id|nct_id|description
2541|NCT03252639|"     This study will use PBV technique to quantitatively assess the improvement of renal perfusion     before and after endovascular treatment (EVT) of renal artery stenosis.   "
1292|NCT03268993|"     Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout     extracts in tablet form, hypothesized to activate protective cellular pathways including     detoxication. In this study, participants who have been curatively treatment for head and     neck cancer, will take Avmacol twice a day for 3 months   "
1298|NCT03268915|"     This study is designed to evaluate the reproductibility and the performance of the 3 minutes     sit-to-stand test in patients with idiopathic pulmonary fibrosis.      To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis     in 2 centers (Grenoble university hospital and Lyon university hospital).      Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the     hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute     sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also     perform a 3 minutes sit-to-stand test with measurement of oxygen uptake.      The investigators will then analyse the results by comparing numbers of cycle, functional     response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The     investigators will also compare the functional response obtained during the 3 minutes     sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test.      Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate     and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on     cycle ergometer.   "
1361|NCT03268057|"     The purpose of this study is to evaluate the safety and tolerability of IV administration of     VX15/2503 in combination with a fixed dose of avelumab in patients with advanced non-small     cell lung cancer. The dose escalation portion of the study will determine the maximum     tolerated dose (MTD) of VX15/2503 administered in combination with avelumab.   "
3764|NCT03236636|"     The primary efficacy index of this study is to compare the OS of the two groups.   "
1311|NCT03268733|"     An open clinical trial   "
1313|NCT03268707|"     A randomized, open, mono-centric pilot study to investigate the influence of an innovative     telemetric smartphone application on re-hospitalization and quality of life after cryoballoon     pulmonary vein isolation in patients with paroxysmal atrial fibrillation.   "
1506|NCT03266328|"     Sample size of 117 patients presented with ST elevated myocardial infarction for PPCI     starting from september 2017 will be divided to 2 groups, group 1 age up to 40 years old and     group 2 older than 40 years then previous history and clinical data and angiographic data at     PPCI and follow up in-hospital and after discharge for 3 months all these data will be     compared at both groups.   "
1334|NCT03268434|"     Aim of the current study is to investigate the acceptance and efficacy of Metacognitive     Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major     depressive disorders in a randomized, controlled, assessor-blind, group trial.   "
1345|NCT03268278|"     To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative     analgesia for endodontic pain   "
1346|NCT03268252|"     The standard regimen for elimination of lymphatic filariasis (LF) in PNG is annual     administration of two drugs at the same time. The two drugs are called DEC     (Diethylcarbamazine, 6 mg/kg body weight) and ALB (Albendazole 400 mg for all individuals     regardless of weight), which are given one time per year for five to seven years with the aim     to interrupt transmission that occurs through local mosquito vectors. These drugs kill the     larval forms of the parasite in the blood that are necessary for continuing transmission of     infection by the mosquito vector. The two drugs were previously thought to have little effect     on adult worms, the stage of the parasite which is responsible for production of the larval     forms that appear in the blood of infected people. Recent data, however, suggest that DEC and     ALB can kill or render adult worms unable to produce the larval forms (sterilization).     Therefore, giving these drugs twice per year for three consecutive years may increase the     rate of killing or sterilizing of adults worms over regimens that involve administration of     the same drugs only one time per year. The overall goal of this research is to compare the     anti-parasite activity of DEC plus ALB given one time per year, the current standard for MDA     to eliminate LF, to DEC plus ALB given two times per year (at 6-month intervals) in order to     reduce the total duration and cost of MDA to eliminate LF in PNG. Adults (18 years and older)     and minors (age 5 to 17 years) will be invited to participate in this study. Study     participants will be asked to give finger stick blood samples to check LF infection status     and stool samples to determine how well the drugs eliminate intestinal worm infections.     Sampling will be done by repeated cross-sectional surveys in the same communities, but not     necessarily the same persons, one time per year over a 3-year period. As part of the annual     treatment infection surveillance the study team will also collect demographic data (place of     residence, family relationship, age, use of bed nets), history of swelling of the arms and     legs (elephantiasis), scrotal swelling (hydrocele), acute filarial fever accompanied by     extremity swelling, and history of prior treatment for LF.   "
1349|NCT03268213|"     The rationale for fecal microbiota transplantation in patients with refractory Clostridium     difficile and/or Ulcerative Colitis or indeterminate colitis is its ability to reconstitute     the normal microbial homeostasis leading to resolution or improvement of symptoms caused by     the bacteria or underlying inflammatory bowel disease. This is becoming an especially     important treatment modality as antimicrobial therapy for Clostridium difficile is becoming     less efficacious due to resistant strains such as the hypervirulent NAP1/ribotype 027 strain.      Currently long-term follow-up data on patients who have undergone FMT is lacking. There are     only scattered reports documenting the alteration of the enteric microbial composition and     function status post transplantation. This study will significantly increase understanding of     the short and long term safety, efficacy, and tolerability of FMT. It will also enable     researchers to assess the change in the fecal microbiome after transplantation. Answers to     these questions may lead to identification of key bacterial taxa to target future therapy.   "
6149|NCT03205384|"     Morbimortality in older patients undergoing abdominal surgery.   "
1355|NCT03268135|"     This study is aimed to investigate the global transcriptome in order to determine the     expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro     noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to     clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers.     To this purpose, both tissue and blood specimens will be collected and patients will be     compared to individuals not affected by cardiovascular diseases.   "
1523|NCT03266107|"     Objective of study is to evaluate the procedural success rate, clinical effectiveness, and     health-economic profile of using the Intracept Intraosseous Nerve Ablation System in adult     subjects with chronic low back pain in the post-market setting   "
1976|NCT03260049|"     The records of patients who were diagnosed with ARN between April 2010 and February 2017 were     analyzed.A retrospective review of the treatment options and outcomes of the these patients     was performed.   "
1356|NCT03268122|"     Hospital-acquired infections are common and frequently lead to poor outcomes, including     death, in affected patients. Two common organisms that cause infections in the hospital are     methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus     (VRE). One strategy used to prevent these infections is contact isolation of hospitalized     patients with MRSA and/or VRE. It is unclear whether contact isolation decreases the rate of     infection with MRSA and/or VRE. The CONTACT-PILOT study is designed to test the hypothesis     that contact isolation decreases the rate of infection with MRSA and/or VRE in patients in     the intensive care unit (ICU). The study will enroll all adults in the Medical ICU and will     run between September 2017 and April 2018. During some months, all patients in the Medical     ICU patients will be placed in isolation for MRSA or VRE if they have a current infection or     colonization with either organism, or a recent history thereof. During other months, patients     will only be placed in isolation for MRSA or VRE if they have an active, highly-transmissible     infection with either organism, such as a pneumonia or an open, draining wound.   "
1364|NCT03268018|"     The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes     using a new calcium atherectomy and modification solution in patients with balloon resistant     calcified lesions in infrainguinal disease. The intent is to both debulk and modify the     vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY     Pilot study will evaluate safety and performance measurements.   "
1370|NCT03267940|"     The study was conducted to assess the safety and tolerability of (1) polyethylene glycol     (PEG) PEGylated Recombinant Human Hyaluronidase (PEGPH20) in combination with cisplatin (CIS)     and gemcitabine (GEM) (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and     atezolizumab (PEGCISGEMATEZO).   "
1371|NCT03267927|"     Assessment of the association of maxillary expansion using a rapid palatal expansion, use of     a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated     position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™     constitute the Yookid system™.   "
1428|NCT03267186|"     This phase II trial studies how well ibrutinib works in preventing acute leukemia in patients     after reduced-intensity conditioning and stem cell transplant. Ibrutinib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
2767|NCT03249688|"     The main aim of the MIND-ADmini pilot trial is to evaluate the feasibility of a multimodal     lifestyle intervention among patients with prodromal AD.   "
1372|NCT03267914|"     Approximately 40 people will participate in this study. This study will compare two different     methods of fluoride application. Both methods are currently used in dental practice and both     have been shown to be effective. If the participant chooses to participate in this study,     participant will be asked to either wear a small tray that has been custom made to fit into     the mouth into which fluoride is placed and worn for 5 minutes at bedtime, or participant     will be asked to brush fluoride onto the teeth for 2 minutes at bedtime. Participant will be     randomly assigned to use one of these methods of fluoride application: participant will not     be allowed to choose which method of application you prefer. Participant will be asked to use     fluoride every night while enrolled in the study. The fluoride that is used in the study is     approved by the United States Food and Drug Administration and is commercially available with     a prescription. After the study is over, participant will need to continue to use fluoride     every night for life to help reduce the risk for dental cavities in the future.      During the study, participant will receive a dental examination every 3 months for a total of     4 study visits over the period of 1 year. This visit will consist of a dental examination to     identify any new cavities and instructions for fluoride use. Participant will also be asked     to complete a written log to document daily fluoride use and to give feedback about     compliance with fluoride use.   "
1373|NCT03267901|"     Investigators planed to conduct a randomized, controlled, crossover trial to examine the     effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary     objective of this study was to investigate the effects of daily walnut intake on changes of     metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This     study was consisted of four periods: run-in, first intervention, wash-out, and second     intervention phases. As 16 weeks of first intervention period began after the run-in phase,     the subjects were randomly assigned into one of two groups: walnut group and control group.     Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants     in control group were provided iso-caloric white bread for first 16 weeks. After the first     intervention and wash-out period (6 weeks), second intervention which is crossover of first     intervention was started during the next 16 weeks. Anthropometric measurements and     biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22,     and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once     during each phase.      Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic     syndrome to normal status especially by reducing waist circumference and improving serum     levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut     consumption on changes of body composition in the subjects with metabolic syndrome, and     3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.   "
1467|NCT03266835|"     This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing     System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System     can facilitate the passage of either devices intended to treat a chronic total occlusion     (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.   "
1390|NCT03267680|"     This randomized phase II trial studies how well cyclophosphamide and IRX-2 work in treating     women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial     neoplasia 3. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. IRX-2 may act as an immune booster to stimulate the     immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical     squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.   "
1419|NCT03267303|"     The purpose of this study is to investigate the efficacy and safety after administration of     TS-091 compared with placebo in patients with narcolepsy.   "
2587|NCT03252041|"     To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.   "
1393|NCT03267641|"     Hepatocellular carcinoma (HCC) is the 6th most common cancer in the world but the 2nd most     important cause of cancer death. Because of its highly heterogeneous nature, the current     approach to identifying druggable targets have not delivered efficacious therapies in HCC and     is a main reason for the high case fatality. Even when surgical resection is potentially     curative in early disease, tumor recurrence remains high and long term survival poor because     of the absence of useful adjuvant therapy.      To address these unmet needs, we bring together internationally recognized scientists from     genomics and immunology and established clinician investigators in a synergistic team. This     TCR capitalizes on recent collaborative advances made by the PIs in the consortium. We have     shown through multi-region sampling of freshly resected HCC and phylogenetic analysis, that     significant intra-tumoral heterogeneity exists and have identified the specific positions of     known clonal drivers. Simultaneously we have analyzed the immune landscape of the tumor     microenvironment with deep immune-phenotyping and found unique inter-patient immune     landscapes predictive of clinical trajectory.      This TCR is a prospective study that samples resected HCC from multi-ethnic sites within the     established Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, which has enrolled     approximately 1000 patients through 6 multi-center trials in 35 centers in the region.     Clinical trajectories are tracked and genomic and immunological studies are repeated when     tumors recu r, to confirm clonally dominant driver mutations and immunological processes that     are targetable. Concurrently, representative pre-clinical models will be developed from the     tissues sampled.      We aim to combine these approaches to overcome the challenges posed by genomic heterogeneity     and to guide the development of therapeutics and precision medicine in HCC.   "
1394|NCT03267628|"     The investigators are comparing post operative analgesia provided for caesarean section     patients, with the quadratus lumborum type 2 block and intrathecal morphine.   "
1395|NCT03267615|"     Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the     Medical University of Vienna will be offered to participate in this prospective observational     trial.      Clinical parameters and laboratory parameters will be recorded for all patients and patients     will undergo a regular follow-up schedule with clinical visits at the Vienna General     Hospital.      This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract biopsies,     liver biopsies and stool collected from the study participants.   "
1396|NCT03267602|"     This is the first study about Neuropsychological function and OSAS in Taiwan. Although the     correlation between OSAS and neuropsychological abnormalities had been reported, it is worth     to understand more about the detailed domains that involved in our cohort. After this,     investigators can dissect the cause of mental retardation in DS and help for further     treatment strategies.   "
1403|NCT03267511|"     The purpose of this study is to determine whether spherical silica can achieve similar or     greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing     higher concentrations of standard abrasive silica, and how the addition of 5% sodium     tripolyphosphate (STP) enhances cleaning capability.   "
1524|NCT03265925|"     This is a prospective study investigating the utility of Brain Network Activation (BNA)     analysis in patients with epilepsy.   "
1407|NCT03267459|"     Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all     pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97%     of 5-years survival rate. Conservative treatments are being more and more used, and intra     arterial chemotherapy is one of the adjuvant treatments proposed to the children. The     treatment is efficient in most cases, but a small proportion of children will have an early     progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find     prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for     early identification of children response to intra arterial chemotherapy.   "
1410|NCT03267420|"     Hypertension is the single most important risk factor for cardiovascular disease and death,     yet blood pressure itself is highly influenced by technique and device. Hence, the target     blood pressure could vary materially based on BP technique and device used. In the present     study, the investigators will compare 4 different methods of measuring blood pressure in the     office (casual, resting average of 3 readings with nurse present or absent for resting     period, and average of 5 readings) as well as a 24 hour ambulatory measurement. The results     of this study will help and enable practicing family physicians and specialists in Canada to     target BP for their patients based on algorithm and method of assessment of BP they use in     their offices.   "
1411|NCT03267407|"     This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal     antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network     laboratories in Vietnam.   "
1413|NCT03267381|"     To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated     from the peripheral blood of patients with melanoma, to identify active disease, provide an     assessment of treatment responses, or predict risk of relapse, in conjunction with standard     clinical assessment and imaging.   "
1414|NCT03267368|"     Pulmonary (lung) rehabilitation, which is done under the guidance of lung     specialists/therapists. It includes breathing exercises, physical exercises, and exercises to     increase tolerance of activity (stamina). This type of lung rehab has been shown to improve     symptoms, quality of life, breathing, and walking distance. It has also been shown to     decrease hospitalization and death rates in chronic obstructive pulmonary disease (COPD) and     lung cancer patients.      Comprehensive Care Management Program (CCMP), a program that includes educational sessions     for tobacco cessation, phone calls, and a home action plan has also demonstrated benefit in     addition to the pulmonary rehabilitation.      In this study, we have an opportunity to identify and intervene with COPD patients. The vast     majority of early stage lung cancer patients are much more scared of their cancer than their     COPD. Upon identification of COPD and recognition of patient tobacco habits for patients     planned to undergo SBRT, interventions can potentially be made that will reduce COPD     hospitalization rates, second primary lung cancer rates, and likely death rates. The     interventions are broadly available and relatively easily instituted and include the     following: seeing a doctor to diagnose their other underlying illness or illnesses (both     respiratory and cardiovascular), smoking cessation if they are smokers, and CCMP's and     pulmonary rehabilitation which have shown measurable COPD benefits in prior trials.   "
1415|NCT03267355|"     The aim is to evaluate the initial experience for the indications and outcomes of EUS in     Tanta university hospital.   "
1499|NCT03266419|"     The aim of this study is to evaluate the influence of depth of neuromuscular blockade during     laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to     either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum     of 12 mmHg.   "
6797|NCT03196908|"     To assess the cardiac effects of energy drink brands in healthy volunteers   "
1416|NCT03267342|"     This project will develop a model for providing low-income people with mental illness with     supports that enable them to manage their money as well as possible so that they are better     able to meet their basic needs, to experience less anxiety about finances, and to live     fulfilling lives in the community with the greatest possible degree of independence. The     project will work within a citizenship-oriented approach to mental health care, which     promotes recovery through linking people with mental illness to the rights, responsibilities,     roles, resources and relationships necessary to achieve full membership in society. The aims     of the project are to: train clinicians and peer staff so that they are able to integrate     discussion of financial issues and concerns into their work with clients; provide on-site     services including financial counseling, peer support groups, help with opening a bank     account, and a savings club, and; develop a 'financial health' model which can be replicated     by other providers of mental health services. The investigators hypothesize that the     intervention will result in improved financial health, reduced financial stress, increased     community participation, and improved satisfaction with care.   "
1417|NCT03267329|"     This study is to evaluate effect and safety on central blood pressure with Duowell compared     to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.   "
1420|NCT03267290|"     Hepatocellular carcinoma (HCC) is unique regarding diagnosis because the clinical diagnosis     without pathology proof is accepted. The dynamic image, including contrast-enhanced computed     tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in     many guidelines for diagnosing the HCC. In contrast to the CT and MRI, ultrasound (US)     with/without contrast is suggested by several societies as the sufficient surveillance     modality. The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the     rapid improvement of contrast medium. In this study, the investigators conducted a     prospective, single-center, open-label trial to compare the efficacy and safety of CEUS +     CEMRI in characterizing HCC, in comparison with CECT + CEMRI.   "
1422|NCT03267264|"     This is a multi-site, prospective, open-label, randomized, 2 period cross over study     comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus     pen needle. The study will consist of two 15 day periods ( in which the subject will use each     pen needle [BD Nucleus pen needle or subject's current pen needle, order randomized] for     injection. At the end of the last study period, each subject will be asked to evaluate his or     her perceptions using a 150mm relative VAS scale.   "
1423|NCT03267251|"     Vaccination against Human Papillomavirus is recommended for adolescent females by the     Advisory Committee on Immunization Practices (ACIP), physicians, and many medical     organizations, yet uptake of HPV vaccines remains very low. CDC data reveal that in 2013 only     44.3% of 13-17 year old females in New Mexico (and 37.6% nationwide) had completed the 3-dose     HPV vaccine series. These data reveal the uptake of the HPV vaccines is unacceptably low,     thereby diminishing its ability to provide population-level protection against the HPV types     known to cause cervical, vaginal, and vulvar cancers in women, oropharyngeal and anal cancers     in men and women, and penile cancers in men. The danger of very low vaccination rates is that     adolescents of all ages will continue to be vulnerable to HPV and the associated cancer     risks.      Despite recommendations for HPV, parents continue to have concerns about HPV vaccination.     Clinicians often lack a clear frame for discussions about HPV vaccination with parents, so     much so that recent research indicates that pediatricians' discussions with parents about     vaccinations in general often take the form of bargaining, e.g., since this may be too early     for the vaccination, can we delay the vaccination schedule? Effective messaging is needed to     close a knowledge gap among parents around HPV and HPV vaccines, improve communication and     shared decision-making about HPV vaccination between adolescent girls' parents and     physicians, and ultimately prompt uptake of HPV vaccines.      This project will employ a web-based intervention on HPV as a way to improve knowledge,     communication and shared decision-making about HPV vaccination for 11-13 year old girls and     their parents. A clinic-based comparative effectiveness randomized trial will be used to     examine the impact of the website on vaccine-related outcomes and vaccine uptake. New Mexico     pediatric clinics will be randomly assigned to either the usual care clinic-based     communication about HPV vaccination or to usual care plus web-based dissemination.     Assessments of vaccine-related outcomes, including shared decision-making between girls,     parents and physicians, will be assessed at baseline, 3 months, and 9 months and vaccine     uptake and dose adherence will be abstracted from clinic vaccine records at 9 months. An     effective web-based resource should increase parents' knowledge, intentions and motivations     to vaccinate   "
1424|NCT03267238|"     Fecal Microbiota Transplantation will be offered to eligible Crohn's disease patient as     Investigational New Drug treatment   "
1425|NCT03267225|"     Main objective- To study the influence of the polymorphisms of nuclear receptor proteins     pregnane X receptor (PXR), Liver X receptor alpha (LXRα), and Cytochrome P450 (CYP450) on the     clindamycin clearance during clindamycin/rifampin combination therapy.      Secondary objectives To study the influence of these polymorphisms on clindamycin clearance,     before combination therapy with rifampin (clindamycin monotherapy) To study the influence of     these polymorphisms on CYP450 activity before combination therapy with rifampin (clindamycin     monotherapy) To study the influence of these polymorphisms on the increase of CYP450 activity     after clindamycin/rifampin combination therapy To study the difference between the expected     and observed clindamycin serum concentrations after dosage adjustment, in patients with     clindamycin dosage adjustment after combination therapy with rifampin   "
1426|NCT03267212|"     The investigators have an existing exercise program (N>70) with a unique population of     individuals with spinal cord injury (SCI) who have been enrolled in Functional Electrical     Stimulation - Rowing Training (FES-RT) for at least 6 months. Previous data in the laboratory     from this exercise platform has recently showed that respiratory restriction in SCI reduces     inspiratory capacity in direct relation to lesion level, and those with high level injuries     have the greatest compromise. As a result, the increase in ventilatory requirements with FES     training results in an imbalance between ventilatory capacity and greater whole body skeletal     muscle demand after FES rowing training. Hence, external ventilatory support could improve     the ability to exercise train and hence enhance the adaptations to chronic exercise in high     level SCI. If our hypothesis is correct, this indicates that maximal aerobic capacity in     these individuals exceeds maximal voluntary ventilation. It will be important to determine     however the consistency of this response and at what level of injury it is not observed. In     parallel of the study # NCT02865343, the investigators will recruit here a population of     subjects who have completed six months of FES-row exercise training across a range of SCI     level (C5-T12). Hence, the investigators will be able to determine the consistency of the     effect and the dependence of the effect on SCI level. Some of them with level >T3 may also     enroll in training effect study with NIV or sham NIV (NCT02865343))   "
6867|NCT03196076|"     The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney     malignancies.   "
1500|NCT03266406|"     The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition     of hyaluronidase on IOP during cataract surgery   "
15142|NCT03087409|"     Collection of follow-up data from the original trial patient cohort.   "
1429|NCT03267173|"     Immunotherapy has become the major breakthrough and the most promising treatment, with the     host of development of tumor biology, molecular biology and immunology. It has become the     fourth tumor treatment model after traditional tumor therapies (surgery, chemotherapy,     radiotherapy) . Mesothelin, PSCA, CEA, HER2, MUC1 and EGFRvIII are potential targets and     spectacular paradigm in the diagnosis and treatment of pancreatic cancer. This study is for     evaluation of the safety and efficacy of Mesothelin, PSCA, CEA, HER2, MUC1, EGFRvIII targeted     and other CAR-T cell immunotherapy for pancreatic cancer.   "
1430|NCT03267160|"     This research will be the first study for exosomes purified in blood and urine from septic     patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine     specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics.     To find the correlations between exosomes biomarkers and hemodynamic parameters.   "
1431|NCT03267147|"     Non-interventional, prospective, observational study to assess the relative risk of anti-CCP     positive patients to develop (subclinical) signs of inflammation in accordance with early     Rheumatoid Arthritis (RA) in a population without pre-classified RA but new1 onset of     non-specific musculoskeletal (MSK) symptoms in general practices in Germany and subsequent 36     months follow-up by rheumatologists   "
1432|NCT03266094|"     The purpose of this study is to assess safety and performance with the use of the BiZact™     device in tonsillectomy procedures in children and adolescents.   "
1433|NCT03266081|"     The objective of this study is to investigate quantitative improvement in excessive tearing     after administration of Bupivacaine, a local anesthetic, into the affected eyelids.   "
1434|NCT03266068|"     Some people develop chronic abdominal pain with diarrhea or constipation after an episode of     acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious     irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact     reason why certain individuals develop these symptoms whereas others don't is not exactly     clear.      The researchers are studying changes in gastrointestinal permeability (movement of contents     across the lining of the intestine) and transit (movement of food through the     gastrointestinal tract). The researchers are also studying if there are any genetic risk     factors that are associated with development of this disorder.   "
1435|NCT03266055|"     There is growing evidence that nutritional intervention with dietary polyphenols can     positively modulate the gut microbiota to improve cardiometabolic health. Whether the     beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to     their potential impact on the gut microbiota and intestinal integrity remains speculative at     this time. Moreover, the mechanisms of action underlying health benefits associated to     blueberry consumption are still unknown. The investigators are thus proposing to combine the     study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity     of highbush blueberries can play a role in the prevention of obesity-linked metabolic     syndrome in a clinical setting.   "
1436|NCT03266042|"     Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have     Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of     Unresectable Hepatic Malignancy   "
1437|NCT03266029|"     Observational study on CHF patients at four sites in Israel. After signing informed consent     and undergoing screening assessments, eligible patients will record a sentence and/or     counting into a smartphone and/or recording machine. The app will upload the vocal data to     the sponsor's servers for analysis.   "
1438|NCT03266016|"     This study is a Phase II controlled clinical trial that will obtain comprehensive, serial     assessments of respiratory muscle strength and architecture to understand the evolution of     ventilator-induced respiratory muscle weakness in critically ill children, and test whether a     novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can     preserve respiratory muscle strength and reduce time on MV. REDvent offers systematic     recommendations to reduce controlled ventilation during the acute phase of MV, and uses     real-time measures from esophageal manometry to adjust supported ventilator pressures such     that patient effort of breathing remains in a normal range during the ventilator weaning     phase. This phase II clinical trial is expected to enroll 300 children with pulmonary     parenchymal disease, anticipated to be ventilated > 48 hrs. Patients will be randomized to     REDvent-acute vs. usual care for the acute phase of MV (interval from intubation to first     spontaneous breathing trial (SBT)). Patients in either group who fail their first Spontaneous     Breathing Trial (SBT), will also be randomized to REDvent-weaning vs. usual care for the     weaning phase of MV (interval from first SBT to passing SBT). The primary clinical outcome is     length of weaning (time from first SBT until successful passage of an SBT or extubation     (whichever comes first)). Mechanistic outcomes surround multi-modal serial measures of     respiratory muscle capacity (PiMax), load (resistance, compliance), effort (esophageal     manometry), and architecture (ultrasound) throughout the course of MV. Upon completion, this     study will provide important information on the pathogenesis and timing of respiratory muscle     weakness during MV in children and whether this weakness can be mitigated by promoting more     normal patient effort during MV via the use of REDvent. This will form the basis for a     larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day     Ventilator Free Days.   "
1439|NCT03266003|"     This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial     (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic     Resistance Solutions Initiative) that will be implemented to evaluate traditional directly     observed therapy (DOT) and electronic forms of DOT (eDOT) for tuberculosis (TB) treatment.     The trial will assess whether eDOT that employs electronic communication methods, such as     video via computer or cellphone, is a non-inferior approach to monitor TB treatment     adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the     physical presence of patients as anti-TB drugs are ingested. ipDOT is the single best     intervention proven to be successful when it comes to TB patients' adherence to therapy     (which reduces risk of acquired drug resistance). However, ipDOT is resource intensive and     many times challenging to facilitate in-person. If eDOT is found to be non-inferior to ipDOT,     health departments and other clinicians might be able to provide eDOT to certain populations     of TB patients in a more flexible and potentially cost-saving manner.   "
1440|NCT03265990|"     Comparison between Haemorrhoidectomy by Ligasure and conventional surgery   "
1441|NCT03265977|"     This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb     infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated     adolescents.   "
1442|NCT03265964|"     This is a randomized, double-blind, placebo-controlled study of the investigational drug     uridine as a treatment for suicidal ideation in veterans.      The investigators hypothesize that the administration of a naturally occurring dietary     supplement, uridine, will rapidly reduce suicidal ideation in veterans. The purpose of this     study is to determine whether 4 weeks of uridine supplementation is an effective treatment     for suicidal ideation in veterans, when compared to a group taking a placebo.   "
1443|NCT03265951|"     Obstructive sleep apnea is commonly reported in Veterans with post-traumatic stress disorder,     which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen     nightmares. Continuous positive airway pressure is the most effective therapy but adherence     to treatment is suboptimal. The overarching theme of the proposal is to compare usual care to     Ramelteon, in a randomized, clinical trial, investigating the effectiveness of physiological     versus pharmacological intervention on sleep quality of life, insomnia severity and CPAP     adherence.   "
1444|NCT03265938|"     Patients who undergo general anesthesia for surgical procedures frequently need to have a     breathing tube placed (tracheal intubation) for the duration of the procedure. Most often     airway management is routine for an experienced anesthesiologist. Less often, airway     management can be difficult and can result in patient harm. In order to reduce risk,     anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and     doing a physical exam, which can aid in predicting which airways may be difficult to manage.     The gold standard for management of the anticipated difficult airway is to perform an awake     flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This     affords added safety because the airway remains patent and the patient breaths spontaneously     until a tracheal tube is secured, at which point general anesthesia can be induced.      Recently, authors have advocated for alternative methods of management of the predicted     difficult airway, most commonly by using a video laryngoscope to perform the awake     intubation. A video laryngoscope provides an indirect view of the larynx using a camera at     the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency     compared to flexible bronchoscopy.      Previous studies that have shown successful awake intubation with video laryngoscopy in the     predicted difficult airway have not included patients with head and neck pathology, including     malignancies or a history of head and neck surgery or radiation. In this study, the study     team will perform video laryngoscopy in patients with head and neck pathology who require     awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction     of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of     the larynx with video laryngoscopy in some patients with head and neck pathology. If there is     a significant incidence of difficult video laryngoscopy in this patient population, it will     reinforce that anesthesiologists need to continue to learn and maintain skills in     bronchoscopic intubation.   "
1445|NCT03267121|"     This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus     tegafur gimeracil oteracil potassium capsules induction chemotherapy in locally advanced     squamous cell carcinoma of head and neck patients who were judged surgically unresectable or     appropriate for non-surgical definitive therapy.The primary purpose of this study is to     evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium     capsules in locally advanced squamous cell carcinoma of head and neck   "
1446|NCT03267108|"     A phase 2b, randomized, double-blind, placebo-controlled clinical study to assess the safety     and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in subjects with pulmonary     fibrosis on long term oxygen therapy (Part 1 and Part 2).   "
1448|NCT03267082|"     A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its     advantages, such as the aesthetic appearance of the wound, less postoperative pain, and     faster recovery which facilitates early discharge, have been highlighted, and the number of     procedures performed has been continuously increasing.   "
1449|NCT03267069|"     This prospective, analytic observational study will investigate alcohol recidivism in     patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver     disease are considered for inclusion. Subjects able to give consent are included.   "
1451|NCT03267043|"     The purpose of this study is to compare neurodevelopment and activity in infants born preterm     (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture     Intervention (FNI) in the neonatal intensive care unit (NICU).      The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic     activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii)     infant behavior and neurodevelopment at 18 months corrected age (CA).      The two-phase effectiveness study aims to:        -  Phase 1 - Examine the existing Standard Care Approximately 30 infants and their mothers        -  Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby          receives the intervention Approximately 30 infants and their mothers   "
1454|NCT03267004|"     The purpose of this investigation is to validate a passive image-assisted dietary assessment     method using images taken by Sony Smarteyeglass and an automatic image analysis software,     DietCam, to identify food items and estimate portion sizes. Participants will be randomized     into one of the two orders of meals (Order 1 and 2). In each meal, participants will be given     a meal that includes a regular-shaped single food (i.e., cookie), an irregular-shape single     food (i.e., ice cream), a regular-shaped mixed food (i.e., sandwich), and irregular-shaped     mixed food (i.e., pasta dish).   "
1455|NCT03266991|"     An open-label, randomised controlled trial comparing compliance to treatment for latent     tuberculosis infection in socially marginalised citizens. Participants will be randomized to     either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed     therapy for twelve weeks.   "
1535|NCT03265782|"     Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in     treatment of Patent Ductus Arteriosus (PDA) in premature infants   "
4288|NCT03229707|"     The aim of this study:      Is to evaluate the accuracy of digital photography in optimizing shade matching when compared     to conventional method of shade selection.   "
1457|NCT03266965|"     Specific Aims:        1. Establish in an open label clinical trial the tolerability and safety of various doses          of l-histidine and lodosyn that may increase levels of l-histidine and histamine in the          serum and cerebrospinal fluid (CSF).        2. Perform pharmacokinetic studies in serum and CSF of study subjects the levels of          l-histidine and histamine after treatment with various combination of l-histidine and          lodosyn.        3. Preliminary information will also be collected on the effects of this intervention on          alleviation of fatigue.      The findings from this study go beyond the effects of histamine on fatigue. If central     histamine can be increased by the strategy outlined above, a number of other vegetative     hypothalamic functions intricately associated with fatigue including sleep, cognition and     satiety need to be examined in MS patients in future studies.   "
1459|NCT03266939|"     In the United States, 1.5 million people abuse cocaine leading to a host of negative health     and economic consequences, yet no FDA approved treatment exists. To develop effective     treatments, the following must be considered: 1) do potential medications ameliorate brain     disruptions associated with cocaine use? 2) are multiple, targeted treatments necessary? To     meet these goals, innovative multi-modal neuroimaging will be used to determine whether     rebalancing the serotonergic (5-HT) system reduces cocaine cue reactivity, impulsivity, and     normalizes related neurochemistry and brain connectivity.   "
2371|NCT03254849|"     In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the     kidney with empagliflozin compared to hydrochlorothiazid on blood pressure and on central     sympathic nervous activity will be examined.   "
1460|NCT03266926|"     In current practice, packing in the vagina overnight after vaginal surgery is typically used     to prevent post-surgical vaginal bleeding. The vaginal packing is usually coated with either     estrogen cream or bupivacaine at the investigators' hospital . There are reports in the     literature that show nasal packing soaked with local anesthetic after nasal sinus surgery     reduces post-surgical pain. To date, no studies have evaluated local anesthetic soaked     vaginal packing after vaginal surgery and if this is associated with a reduction in     post-surgical pain scores.      The investigators seek to investigate if vaginal packing soaked with a local anesthetic     reduces post-operative pain while providing the necessary action of minimizing potential     post-surgical bleeding.   "
1463|NCT03266887|"     Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik     cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of     25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with     survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with     cancer in association with 25(OH)D levels. In this population living just south of the arctic     circle, vitamin D levels largely depend on dietary- and supplemental sources.   "
1954|NCT03260335|"     This study aims to explore whether feedback from a physical monitoring device (electronic     watch) to prompt patients to use an anxiety management strategy can help prevent challenging     behaviour.   "
27954|NCT02919839|"     Personalized medicine methods in the management of type 1 diabetes   "
1471|NCT03266783|"     Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute     symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both     approved by Health Canada. No safety or efficacy data is available from direct head-to-head     comparison of these two anticoagulants. Lawsuits in the United States over bleeding events,     patient perceptions, and concerns with medication adherence are additional factors     highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective,     randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of     apixaban and rivaroxaban for the treatment of VTE.   "
1472|NCT03266770|"     Traditional ureteral stents are commonly used in renal and ureteral procedures, and their use     is associated with many morbidities which can affect patients' quality of life. However,     replacement of the distal portion of the stent with a thin material may reduce bladder     irritative symptoms and allow the ureterovesical junction to coapt---thereby, reducing     urinary reflux. The hypothesis is that the RELIEF stent will offer the same function of     traditional ureteral stents with the added benefits of minimizing urinary reflux and reducing     irritative bladder symptoms.   "
1476|NCT03266718|"     This pilot study will develop and test a couple-based physical activity intervention among     cancer survivors and their partners.      Aim 1: To determine the feasibility and acceptability of a couple-based physical activity     intervention for cancer survivors. Feasibility will be quantified using rates of study     eligibility, overall accrual, attrition, and adherence to the study protocol. Acceptability     will be assessed via couples' ratings on a standardized measure of treatment effectiveness/     satisfaction, supplemented open-ended questions      Aim 2: To provide preliminary data on the effects of a couple-based physical activity     intervention relative to a wait list control group on survivor outcomes (i.e., level of     physical activity, quality of life, self-efficacy for achieving and maintaining physical     activity goals, perceived partner support for physical activity, and quality of the     survivor-partner relationship). The investigators hypothesize that the intervention will     produce benefits in each of these domains.      Aim 3: To provide preliminary data on the effects of a couple-based physical activity     intervention relative to a wait list control group on partner outcomes (i.e., partner's level     of physical activity, self-efficacy for helping the survivor achieve and maintain physical     activity goals, and quality of the survivor-partner relationship). The investigators     hypothesize that the couple-based intervention will produce benefits in each of these     domains.   "
1477|NCT03266705|"     2 different formulations and doses of tafamidis will be compared. All subjects will receive     both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they     will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects     will be fasted before taking the drug. Blood samples will be taken to measure the amount of     tafamidis starting on day 7 and ending on day 8. At least 16 days after the first     formulation/dose is given, all subjects will repeat the procedure with the other     formulation/dose.   "
1478|NCT03266692|"     This is a phase 1, multi-center, single-arm, open-label study evaluating the safety,     tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in     combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory     Multiple Myeloma.   "
1479|NCT03266679|"     The aim of this study is to trial an intervention targeting potential deficits in an     individual's ability to form, and reflect upon, ideas about themselves and others (known as     metacognitive capacities), specifically in relation to individuals diagnosed with a bipolar     mood disorder (BMD).      The proposed research will adopt a mixed qualitative and quantitative design. Participants     will be recruited through hospital outpatient groups (i.e., Metro South Addiction & Mental     Health Services Woolloongabba Community Health Centre & Beenleigh Community Health Centre in     Brisbane, Queensland), and, as necessary, local non government organisations (NGOs),     psychiatrists, general practitioners, online support networks (SANE Australia, Black Dog     Institute), community mental health services(such as MINDNET), and/or social media groups     (Facebook, Twitter) supporting people who meet criteria for a BMD. The research will then use     clinical interviews and quantitative (survey) methods to: (1) confirm diagnosis of     participants; and (2) confirm deficits in metacognitive capacities of participants. Following     this, the research will then involve the implementation of an adapted intervention across a     course of 12 months, aimed at improving the metacognitive capacities of participants with a     diagnosis of a BMD.      The research will provide an enriched understanding of a dimension of people with BMDs that     has not been previously explored. The research will help with gaining an understanding of the     metacognitive processes of people with BMDs, and inform more targeted psychological     interventions.   "
1977|NCT03260036|"     The aim of the project is to investigate the metabolic regulation of the hepatic urea     nitrogen handling and various cognitive functions measured by psychometric and     neurophysiological tests before and after bariatric surgery in patients with non-alcoholic     fatty liver disease (NAFLD).   "
1480|NCT03266666|"     Wellness Rx is a 6 class prescription for a healthier lifestyle developed for people in Lake     County at all levels of health including those struggling with chronic disease. The classes     are running across the community at all times. It is designed for patients that could benefit     from healthy diet, exercise, and other healthy lifestyle modifications.      For those participants attending the classes, they have the option of engaging in this     evaluation. For those that do, participants will answer questions about their current     lifestyle, their and their previous history. They will register attendance at each class and     answer questions about their perception of the class. Then at 45 days and 90 days the     participants will revisit the same baseline lifestyle questionnaires.      As participants attend classes, and complete questionnaires, they'll unlock grocery credits     from online food store ThriveMarket, a basket of fresh produce from the local farmers market     and local fitness classes to help you towards your goals. The use of these credits will be     tracked through the 90-day point.   "
1481|NCT03266653|"     Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with     the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children,     adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem     Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).   "
1482|NCT03266640|"     CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine     Capture System will be administered in children, adolescents and young adults (CAYA) with     refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell     Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).   "
1484|NCT03266614|"     This study is a randomized trial evaluating Recovery 4 US, a social media program aimed at     the enhancement of community participation and overall recovery of individuals with     psychiatric disabilities.This innovative e-mental health program integrates Internet and     mobile technologies and is designed to be a self-sustaining recovery-oriented virtual     community for individuals living with a disabling mental illness based on the principles of     Photovoice.   "
1485|NCT03266601|"     This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness     of aerosol inhalation of recombinant human interferon α-2b compared with ribavirin treatment     on pediatric patients with herpangina.   "
1486|NCT03266588|"     The purpose of this study is to evaluate safety and tolerability of BHV3000 (rimegepant).   "
1502|NCT03266380|"     The primary objective of this study is to assess the incidence of VAP in patients with TBI     and to identify risk factors for developing VAP in this specific patient population (types of     co-injuries in patients with multiple trauma or characteristics on admission). The secondary     objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP     in patients with TBI. The tertiary objective is to discuss the ability of preventive measures     to reduce the incidence of VAP   "
1489|NCT03266549|"     Infantile esotropia is defined as the onset of constant convergent squint in children less     than 6 months of age. Infantile esotropia is mainly treated surgically using either bilateral     medial rectus muscle recessions or unilateral medial rectus muscle recession and lateral     rectus muscle resection with the main goal being to align the eyes so that single binocular     vision may develop. For infants with very large angles of esotropia (>60 prism diopters     (PD)), surgery on 2 muscles alone may not be adequate. Approaches to these patients have     included large bilateral medial rectus muscle (MR) recessions, smaller bilateral medial     rectus muscle recessions combined with resections of 1 or both lateral rectus muscles (LR) or     botulinum toxin augmented bimedial recession. Botulinum toxin augmentation of medial rectus     muscle recession was reported in three previous studies. Lueder et al evaluated the long-term     outcomes in patients with infantile esotropia. The results were good, with a 74% success     rate. Based on historical comparisons, this technique appears equally as effective as 3- or     4-muscle surgery and more effective than large bilateral medial rectus recessions alone.     Ideally, a prospective randomized study should be performed to more definitively determine     which of these approaches is best.   "
1490|NCT03266536|"     Does the small bowel microbiota in healthy individuals change after consumption of a Western     diet?   "
1491|NCT03266523|"     VERTIM study aims to evaluate the influence of different environments of imaging waiting     rooms on the anxiety felt by patients before MRI or CT scans. For this, four environments     (neutral/standard; and nature green, sea, and zen) will be set up in MRI and CT waiting     rooms.   "
1492|NCT03266510|"     The purpose of this study is to assess the efficacy of inspiratory muscle strength training     for lowering blood pressure and improving physiological function (vascular, motor, and     cognitive) in middle-aged and older adults with elevated systolic blood pressure.   "
1493|NCT03266497|"     This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks     using pooled NHANES data.   "
1494|NCT03266484|"     The study is proposed as a single-site randomized double-blind placebo-controlled trial     requiring 4 study visits, where two of the visits are combined with their appointment for     routine clinical care. The study population will consist of patients with quiescent CD and UC     and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis     center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified     according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible     patients will be contacted at the time of their routinely scheduled office visit and     consented for the study. Self-report and review of medical records will be used to obtain     detailed information regarding their disease on an intake questionnaire completed by a     research study coordinator.      The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic     supplement compared to placebo. We propose to examine the effect of a specific probiotic     supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue     symptoms in patients with quiescent IBD.      Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline     visit. The patient will receive either the probiotic supplement or placebo for 4 weeks.      The first follow up visit will be at week 4 to check for adverse events on study treatment,     to check accountability of probiotics/placebo, and to complete the set of questionnaires.     Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment.      At week 8, subjects will receive a phone call from a study research coordinator to check in     with probiotics/placebo intake for treatment compliance and accountability records, and to     complete the set of questionnaires ascertaining subjective symptoms.      Last study visit will be at week 12 which is often combined with a regular office     appointment. Subject will provide serum blood and stool sample, as well as complete the set     of questionnaires.   "
1497|NCT03266445|"     The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in     patients with history of Opioid Use Disorder (OUD) scheduled for upper and lower extremity,     thoracic and abdominal surgery compared to discontinuation of buprenorphine/naloxone 3 days     prior to surgery on pain scores, opioid consumption, patient satisfaction, and severity of     substance use dependence- including record of problematic use of any non-prescribed opioids,     alcohol and illicit narcotics.   "
1501|NCT03266393|"     Adolescents commonly experience barriers to adherence that entail forgetfulness, distraction,     poor planning, and scheduling problems. A once daily oral regimen may be superior to the     current regimens that require twice daily dosing. It is currently unclear if Envarsus XR®     would improve outcomes in adolescent organ transplant recipients. Each patient will receive     tacrolimus (twice daily immediate release oral formulation) which they are using as part of     their standard of care immunosuppressive regimen for a portion of the study and Envarsus XR®     (a once daily extended-release oral tacrolimus formulation) for a portion of the study in a     cross-over design. Besides the advantage to adherence behaviors, a sustained-release     tacrolimus preparation may decrease burdensome side effects and increase quality of life.     Following enrollment, each patient will be maintained in the study for 9 months.   "
1504|NCT03266354|"     the investigator will evaluate the change in endothelial cell count in eyes implanted with     the iris-claw phakic Artisan lens for treatment of moderate to high myopia using specular     microscopy   "
1507|NCT03266315|"     Probiotics have been started in the NICUs in Calgary since 2016 aiming to decrease the     incidence of NEC. Adults with abdominal surgery who received post-op probiotics reported a     significant reduction in surgical site infection, urinary tract infection, and combined     infection. Currently probiotics used only in none-surgical population of infants The main     objective of this study is to determine the impact of probiotics administration on length of     hospital stay in neonates undergoing intestinal surgery. The study will also generate     important data about safety and efficacy of probiotics in this surgical population.   "
1509|NCT03266289|"     Primary aim: evaluation of the short term outcome of different techniques used in     bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE):     cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis     and occurrence of Unstable angina (UA) with ECG changes and echo findings in the same target     vessel in Assiut university Cath. lab.      Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention     in Assiut University Cath.lab   "
1510|NCT03266276|"     Rates of depression and anxiety in cancer patients are much higher compared to the general     population. 40% of head and neck cancer patients will develop significant distress along the     cancer journey. Less than half of these patients are able to access support, with factors     such as age, social difficulty, cancer stage and site affecting referral. In 2016, 78,000     Canadians died of cancer, yet there is limited implementation of routine and integrated     advanced care planning in cancer care.      An upcoming deliverable of all cancer centres in Ontario is the integration of Cancer Care     Ontario's Psychosocial and Palliative Care (PSOPC) pathway into all disease pathways.     Successful widespread implementation of this pathway at Odette Cancer Centre (OCC) will     impact >16,000 patients/year. If effective, it will reduce suffering, unnecessary healthcare     utilization, improve treatment decisions and compliance, enable a better quality of life in     survivorship and improve quality at end of life. There is a need for better developed,     standardized response pathways to address PSO and PC needs throughout the patient's journey.   "
1511|NCT03266263|"     High-quality cardiopulmonary resuscitation (CPR) and early defibrillation are the most     important parts of the chain of survival, and they are highly associated with the survival     rate and life quality of patients with cardiac arrest. It needs the witness to perform     bystander CPR and use the automated external defibrillator (AED) if CPR and defibrillation     are expected to be performed earlier. Nevertheless, few patients with cardiac arrest received     bystander CPR in Taiwan. It might be caused by some reasons. First, traditional training     programs were inefficient and ineffective in the retention of skills and thus students were     not confident in their CPR skills after receiving training programs. Second, the current     training module focused on personal skill training only and lacked teamwork skills training.     It led to poor performance of the students in actual resuscitation scene, where on-scene     resuscitators were usually more than one. Third, the current training contents did not     improve the attitudes and willingness of performing bystander CPR and it caused people who     had received training program did not resuscitate the patients finally. To improve the     above-mentioned problem, a three-year research project will be implemented. The aims of the     project are the following:        1. to explore the effect of different teaching contents and hand-on practice feedback          methods on the students' performance of chest compressing, ventilating and using AED in          the CPR and AED training courses.        2. to analyze the current situation of teamwork when CPR and AED were performed, to build          up the collaborating module accordingly and evaluate the effect of the new module on the          students' performance of chest compressing, ventilating and using AED after the module          is introduced into the training course.        3. to understand the factors affecting the motivations and willingness of people to learn          and practice CPR and AED by utilizing questionnaires, and then to evaluate the effect of          the creative program, which was modified according to the results of the questionnaires,          on the motivations and willingness of people to learn and practice CPR and AED.      The investigators expect to design a more efficient resuscitation skill training course by     implementing the research project and further to improve the motivations and willingness of     people to learn and practice CPR and AED in the future.   "
1513|NCT03266237|"     The aim of this study is to characterize the immune profile of frail and healthy aged     individuals and investigate their immune responsiveness including the response to influenza     vaccine over an 18-month period. The project will include a longitudinal study to define     immune signatures and multi-parameter profiles associated with frailty and may lead to the     identification of predictive markers of evolution to frailty and Immunosenescence in the     elderly.   "
1522|NCT03266120|"     The objective of the research is to test the hypothesis that participating in group-based     gardening or group-based art activities may alter the mental health and cardiac physiological     status of a wellness population of women ages 26-49. Assessment of the effects of gardening     or art activities on the experimental population will take two approaches, the first being     the use of physiological measurements of heart rate and blood pressure. The second approach     will employ six widely used and well-established self-reported assessment instruments that     will capture information about the health and well-being of participants. These measurements     and assessments will provide a psychometrically-based before and after mental health status     and between treatments health summaries of the participants in the gardening group and those     engaged in the art group activities.   "
19746|NCT03027089|"     Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)   "
1515|NCT03266211|"     In the last ten years, more than one hundred generalized tetanus cases were declared in     France. Most of them were affecting people older than 70 years with an important mortality     (around 28%). It is know that the only way to protect ourselves from this disease is the     vaccination. In France tetanus vaccination is mandatory since 1940.      Nowaday none study looked specifically for the vaccination of people older than 65 years. The     hypothesis is: there is a difference in the tetanus vaccination coverage for people older     than 65 years depending on the demographic and medical practice of their general     practitioner.   "
2035|NCT03259269|"     This observational study will examine the safety and efficacy of bedaquiline and delamanid     used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The     information gathered in this study will inform doctors how best to use these TB drugs in the     future.   "
1516|NCT03266198|"     Normal fetal growth is a critical component for a healthy pregnancy and for ensuring the     health and well-being of infants throughout childhood and adolescence. One promising area of     research suggests that changes in fetal soft tissue may be the earliest changes that occur in     pathologic growth. Three-dimensional volume assessments may be used to detect changes in     fetal lean mass, fat mass, and organ size that result from pathologic growth earlier than     conventional 2D measures. This knowledge may lead to interventions that could minimize or     prevent pregnancy and newborn health problems in the future.   "
1517|NCT03266185|"     Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects for patients.     Scalp cooling can prevent or minimise CIA in approximately half of all patients, depending on     many factors, e.g. type and dosage of chemotherapy. High rates of success are seen in     patients treated with taxanes, up to 80-90%. Previous research has shown comparable results     of scalp cooling in docetaxel-treated patients when shortening the post-infusion cooling time     (PICT) from the initial standard of 90 minutes to 45- and 20 minutes. A shorter PICT is an     advantage for both the patient, who can spend less time in the hospital, as well for the     logistics at oncological departments. Paclitaxel and docetaxel are both classical taxanes,     that share similar mechanisms of action and have comparable plasma terminal half-life times,     therefore it seems plausible that the PICT can be shortened for paclitaxel-treated patients     as well.   "
1518|NCT03266172|"     This study will evaluate the pharmacokinetics of GSK2982772 following administration of     modified release formulations in a capsule relative to an immediate release reference tablet     formulation and the pharmacokinetics of escalating repeat doses of a selected modified     release prototype. The study is divided into two parts: Part A will be a non-randomized 6     periods, sequential, 6-way fixed sequence design in which up to 4 MR minitab formulations of     capsules will be evaluated. Periods 1, 2, and 3 will evaluate a slow MR release duration     (nominally 24 hours), a fast MR release duration (nominally 10 hours), and IR tablet     respectively. Periods 4, 5 and 6 will have flexible dose regimen and it will depend on the     outcomes of Period 1 to 3. Subjects will be admitted to the clinic the previous day before     dosing. Each in-patient period will consist of 3 days and 2 nights followed by a minimum     washout period of 7 days between doses. In Part A 16 healthy subjects will be enrolled such     that at least 12 evaluable subjects complete the study. Part B will be an open-label, repeat     dose study in which the selected MR minitab formulation in capsule will be evaluated. Each     in-patient period will consist of 5 days and 4 nights. There will be a minimum of 7 days'     washout period between the last morning dose of one period and the first dose of the next     period. In Part B 10 healthy subjects will be enrolled.   "
1519|NCT03266159|"     GSK525762 is a novel inhibitor of bromodomain and extraterminal (BET) proteins. Trametinib is     a potent inhibitor of the mitogen-activated protein kinase proteins (MEK1 and MEK2).     GSK525762 and trametinib are critical for growth and survival of tumor cells. This will be     the first study demonstrating the synergistic effect of BET inhibitor and MEK inhibitor     administered together against tumor cell growth. This study aims to evaluate the safety,     tolerability, PK, PD, and preliminary efficacy of combination of GSK525762 and trametinib     when administered concomitantly to subjects with small cell lung cancer (SCLC) and rat     sarcoma virus oncogene homolog (Ras) mutated solid tumors. The study will be conducted in two     parts; part 1 will consists of dose escalation and dose expansion cohorts and part 2 will     consists of four disease specific cohorts (SCLC, Ras-mutated adenocarcinoma [RMAC] of the     colon [Ras-mutated colorectal cancer {RMCRC}] and/or rectum, Ras-mutated non small cell lung     cancer [RMNSCLC], Ras-mutated pancreatic adenocarcinoma [RMPAC]) and an optional basket     cohort (Ras-pathway activated solid tumors [RAST]). Part 1 will focus on selection of the     Part 2 dose based on safety/tolerability, PK, PD, and efficacy. Part 2 will investigate the     overall response rate and clinical response. The total duration of study will be     approximately three years (nine to twelve months for part 1 and two years for part 2).     Approximately 138-156 subjects will be enrolled in the study.   "
1520|NCT03266146|"     This study is to observe the efficacy and safety of 36 weeks short-term optimization     treatment of glucocorticosteroid in the patients with chronic recurrent drug-induced liver     injury (DILI).   "
1521|NCT03266133|"     This is a pilot randomized controlled trial involving a sleep education intervention in women     with gestational diabetes to study whether sleep education during pregnancy leads to     improvement in glycemic control in women with gestational diabetes and improvement in sleep     duration.   "
1525|NCT03265912|"     mTBI is widely recognized as a major public health concern in the United States and     worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every     concussion. Recent advances in EEG evoked response potential analysis have led to a novel     technique for assessing brain network activation (BNA) patterns. This study purpose is to     study this BNA technology in individuals who have sustained a concussion.   "
1526|NCT03265899|"     The purpose of this study is to determine whether oxytocin modulates the processing of     stress-associated chemosignals and which substrates are involved.   "
1527|NCT03265886|"     Despite PH adjustment of local anesthetic solution improves the quality of the block in all     respects with special advantage of early onset of sensory and motor block, adequate level of     analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should     have the same effect which have not been evaluated on supraclavicular plexus block for upper     limb surgery.      The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor     block onset and prolong the duration of analgesia when compared to bupivacaine at operating     room temperature.   "
1528|NCT03265873|"     Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers,     used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the     reference technique. IMRT requires a precise definition of the target volumes to be treated     and the anatomical structures to be protected from irradiation. Most studies of head and neck     cancers published in the literature demonstrate the variability in the contouring of the     target volumes between radiotherapists. This may have an impact on dosimetry. To date, no     studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The     aim of this study is to compare the volumes determined by the radiotherapists alone and those     determined jointly by the radiotherapists and the ENT surgeon.   "
6770|NCT03197259|"     A prospective, multicenter national observational study for patients diagnosed as chronic     lymphocytic leukemia across 25 centers in Turkey   "
1530|NCT03265847|"     This study evaluates the impact of administering culturally-specific versions of the Danger     Assessment (DA) tool followed by the tailored safety planning/referral via use of     internet/smartphone-based safety decision aid (SDA) on immigrant, refugee and indigenous     women's empowerment, safety and mental health. Half of survivors will receive tailored safety     planning/referral based on their level of risk assessed by the DA, while the other half will     receive non-DA informed usual safety planning/referral.   "
1531|NCT03265834|"     Complicated intra-ABdominal Infections (CABIs) are abdominal infections where there is an     abscess inside the abdomen, or a hole (perforation) in an abdominal organ such that infected     material e.g. faeces, leaks into the abdominal cavity. A recent review of CABIs after gut     surgery found that they can occur in several ways. They can occur in different parts of the     abdomen, can be different sizes, and may or may not be caused by a perforated bowel.     Management includes, where possible, surgical drainage of an abscess or treatment of the     damaged bowel. In addition, all patients are given antibiotic therapy. Despite the varied     ways that CABIs occur, we currently tend to treat all CABIs with antibiotics in a similar     way. CABIs are associated with significant morbidity and mortality. Despite a significant     amount of disease there is little clinical evidence with which to base treatment on. One     research study evaluated a short course of antibiotics (4 days) compared with a longer course     (up to 10 days) in combination with surgical removal of infection. There was little     difference in outcomes, but in both groups about 1 out of every 7 patients had a relapse. A     recent review of patients with CABI in Leeds, not in a research study and where surgical     removal infection is uncommon and antibiotic durations were short, showed that the risk of     relapse was even higher (about 1 in every 3 patients). The antibiotic management of CABIs in     the UK is variable and involves giving between 4 days to 28 days of antibiotics.      In summary, there is an unacceptably high relapse rate in patients treated for CABI, and     uncertainty about the best length of antibiotic therapy that should be used to prevent these     relapses. We therefore propose to investigate if long course antibiotic therapy (28 days) is     more effective than short course antibiotics (≤10 days) in preventing relapses of CABI.   "
1532|NCT03265821|"     The aim of this study was to investigate whether cigarette smoking had any impact on the     clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680     individuals 20-85 years, referred to the specialised clinic for periodontal treatment at     Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals     filled in a questionnaire regarding their medical health, medication and smoking habits.      Excluded were edentulous individuals and where clinical data 1-year after active treatment,     or smoking habits were missing (n=1453). Complete data for analyses was available for 4227     individuals.   "
1533|NCT03265808|"     Eighty (80) subjects with Alcohol Use Disorder and Comorbid Major Depression, fulfilling all     inclusion/exclusion criteria's will be randomly assigned to receive allogeneic human     Mesenchymal stem cells or placebo in a 1:1 blinded fashion.   "
1537|NCT03265756|"     Pneumonia is a major cause of illness in young children. The investigators are developing and     testing a new thermometer like device called Multimometer, to measure the respiration rate     (RR), temperature, heart rate (HR) and the degree of blood oxygenation (SpO2) of children who     may suffer from pneumonia. These are called vital signs and their measurements greatly help     to diagnose pneumonia.      In the first part of the study, and in order to optimize and better align the size of the     device with the face, the investigators will measure the average size and dimensions of young     children's face. In the second part of the study, the investigators will compare the vital     signs measurements with measurements obtained by other commonly used devices in ill children     who are suspected to suffer from pneumonia.   "
1538|NCT03265743|"     The main risk factor for the development of cervical lesions is human papillomavirus (HPV)     infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to     14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical     pathology. Despite this, human papillomavirus vaccination coverage remains low in France.      Some women with cystic fibrosis might need a transplantation, which is a factor associated     with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of     cervical pathology would also be present in non-transplanted women with cystic fibrosis.     Particular attention should therefore be paid to vaccination in this population.      The objective is to estimate the frequency of human papillomavirus vaccination in young     patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.   "
1539|NCT03265730|"     Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be     encountered between two hours to two months after starting of antibiotics. The purpose of the     study is to determine incidence,risk factors and severity of pediatric antibiotic associated     diarrhea in Turkey.   "
1540|NCT03265717|"     Phase 2 study to assess the efficacy of INVAC-1 at a dose of 800 µg for 6 cycles 4 weeks     apart on Minimal Residual Disease (MRD) eradication rate in the bone marrow, either as a     single agent in a high risk watch and wait group (group 1 - 42 patients) or in combination     with ibrutinib (group 2 - 42 patients), in patients with Chronic Lymphocytic Leukemia (CLL).      Pharmacodynamics and safety will also be assessed.   "
1541|NCT03265704|"     Maternal high blood pressure remodels the intrauterine environment of the fetus by altering     hormonal and cellular signaling patterns and, as a result increases the risk of fetal and     neonatal mortality and morbidity. Newborns of these mothers have an increased risk of     intrauterine growth restriction, premature birth and hematological abnormalities, such as     thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review     neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure     and to establish the optimal management of these cases.   "
1542|NCT03265691|"     Cross ecological quasi-experimental study to assess effectiveness of early intervention in     the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´     falls.   "
1544|NCT03265665|"     The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 8-month     community-based walking intervention refined to be applicable for sedentary African American     (AA) women with asthma. The main outcome of this study is to test the feasibility,     acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled     pilot of 80 AA women with asthma within a pragmatic community setting.   "
1546|NCT03265639|"     The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study     of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.   "
1549|NCT03265600|"     Among primary care patients, compare the effectiveness of an 8-week mindfulness-based     intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness     introduction comparator on self-management of chronic illness and illness-related health     behavior action plan initiation, as well as on measures related to anxiety, depression, and     stress.   "
6846|NCT03196349|"     Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous     Thromboembolism.   "
1550|NCT03265587|"     Objective: To assess whether the feng shui of critical care bed spaces affects the inner     harmony of nursing staff Design: Prospective cohort study Setting: Doncaster critical care     department Participants: Critical care nursing staff Main outcome measures: To assess     self-reported chi scores and their response to feng shui, cake ingestion and ghost sightings   "
1551|NCT03265574|"     PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI)     enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer     undergoing adjuvant epirubicin-based chemotherapy.   "
1552|NCT03265561|"     Background. Bone infections can involve the vertebral column, intervertebral disc space,     spinal canal and soft tissues, can generate neurological deficit in addition to the     destruction of the bone that causes functional disability. Vertebral osteomyelitis is the     most frequent, affecting 2 to 7 patients per 100,000 habitants. Management is bone     debridement and bone reconstruction.      Objective. Demonstrate that the use of bone allograft is a functional method to stabilize the     spine after a bone spinal infection Material and methods. Patients with vertebral bone     destruction are included in two groups. Bone allograft group will receive bone structural     allograft; Auto and allograft group will receive bone structural allograft plus autograft.     The bone reconstruction will be performed in a one-time surgical procedure. Bone     consolidation, pain, functionality, and spine deformity will be evaluated.   "
1553|NCT03265548|"     Our research questions are        1. Will the use of a video laryngoscope lead to decreased attempts        2. Does this result in more successful intubations and greater confidence in the supervisor          and the team that a successful intubation has been performed.   "
1554|NCT03265535|"     We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia.     Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan     single-injection protocol and the myocardial blood flow of both techniques will be compared.   "
1555|NCT03265522|"     Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health.     Mild cognitive impairment (MCI) describes problems with brain function such as difficulty     with day-to-day memory and concentration. It is at this stage that Mediterranean diet could     prove beneficial in terms of prevention.      Previous research by Queens University investigated the opinions of patients with MCI and     their care givers to inform the development of Mediterranean diet education material to     encourage behaviour change. The study suggested that MCI patients lacked awareness of the     link between Mediterranean diet and brain function, although were interested to learn more.     Feedback on the developed educational material was positive although there were suggested     improvements such as tailoring information to memory loss, a potential staged approach to     delivery and adaptations to the material content.      This present study aims to pilot test refined educational material among MCI participants to     evaluate the feasibility of encouraging dietary behaviour change among this patient group.   "
1556|NCT03265509|"     The objective of this study is to determine to effect of additional oral glutamine to Kegel     exercises on pelvic floor strength and clinical parameters of urinary incontinence in females     with either urinary incontinance (stress and/or urgency) and pelvic prolapse.   "
1557|NCT03265496|"     Condorde main objective is to evaluate the correlation between EGFR mutational status     determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid     biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next     Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.   "
1558|NCT03265483|"     One striking observation is that a large portion of the inter-person variation in serum     25-hydroxyvitamin D (25(OH)D) levels is unexplained. In vitro and in vivo studies indicate     vitamin D synthesizing and metabolizing enzymes are Mg-dependent. Magnesium (Mg)     supplementation substantially reversed the resistance to vitamin D treatment in patients with     magnesium-dependent vitamin-D-resistant rickets. The investigators reported in 2013 from     observational studies conducted in the general US population that Mg intake significantly     interacted with vitamin D intake in affecting vitamin D status as well as interacted with     serum 25(OH)D in risk of cardiovascular disease mortality and, maybe, colorectal cancer     mortality. The potential interaction between Mg and vitamin D was supported by two subsequent     studies, including a Finnish cohort study and a mouse study.      In the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT01105169), the     investigators proposed to measure blood concentration of total 25(OH)D as a secondary aim     using Elisa approach. However, following the novel finding of Mg-vitamin D interaction     published by the investigators in 2013, they submitted a separate grant application to NCI     which was funded in 2014. In the new study, the investigators proposed to use a LC-MS     approach, which is more accurate and specific than an Elisa method, to measure 5 vitamin D     metabolites. This new ancillary study allows the investigators to evaluate whether Mg     supplementation differentially affects vitamin D synthesis and metabolism dependent on     baseline serum 25(OH)D levels using existing biospecimens collected in our double-blind     placebo-controlled randomized chemoprevention trial.   "
1559|NCT03265470|"     Acute kidney injury and chronic kidney disease usually associated with radical cystectomy     operation which is the treatment of choice for invasive urinary bladders tumor.     Peri-operative acute kidney injury (AKI) is common but poorly recognized and managed which is     associated with increase surgical morbidity and mortality and hospital cost .Prospective     human studies establishing a renal protective effect of dexmedetomidine are still     questionable.   "
1560|NCT03265457|"     Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of     coexisting cataract and glaucoma. It may be associated with a less than normal endothelial     count.   "
1561|NCT03265444|"     The purpose of conducting phase 1 trial is to evaluate the safety and tolerability of     autologous bone marrow-derived mesenchymal stem cells(CS10BR05) in subjects with Multiple     System Atrophy.      Evaluation of DLT by carotid artery(intra-arterial) injection according to dose-escalating in     Multiple System Atrophy.   "
1616|NCT03264729|"     This study investigates the acute effect of isotonic versus isometric exercise versus walking     on pain in individuals with plantar heel pain and an ultrasound-diagnosed plantar     fasciopathy. The hypothesis is that isometric exercise will induce greater participant rated     pain relief than isotonic exercise and walking during aggravating activity.   "
22203|NCT02995122|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
1562|NCT03265431|"     This study is performed to assess if PET-MR imaging can improve treatment of patients with     irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too     weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One     category of irregular heart rate is called ventricular arrhythmia. It is often seen in     patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause     sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the     source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation     does not fix the problem in 100% of patients and some will still have the arrhythmia     requiring repeated procedure. The purpose of this study is to find new ways of guiding the     doctors performing ablation, hoping to improve the success rate of the procedure.   "
1563|NCT03265418|"     To test the feasibility and accuracy of BioXmark fiducial markers for image guided     radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course     chemo-radiotherapy of the locally advanced rectal cancer.   "
1565|NCT03265392|"     Some literature data and the results of our in vitro studies strenghten the idea that the     role of salivary alpha-amylase in starch digestion has been under-rated and that this enzyme     can an important role in this process. As a result, its inhibition could constitute an     opportunity to reduce the glycemic response elicited by starch-rich foods. The main goal of     this study is to verify whether inhibition of salivary alpha-amylase, upon the consumption of     starchy foods, can have an impact on the postprandial glycemic response, and/or satiety.   "
1566|NCT03265379|"     Although chest wall recurrence of breast cancer is uncommon, it represents a difficult     clinical scenario. The role of full thickness chest wall resection (FTCWR) for breast cancer     recurrence in the chest wall is controversial and is complicated by the fact that no     prospective evidence exists evaluating the utility of FTCWR in prolonging survival or     improving health related quality of life (HRQOL) and thus, there is a lack of evidence to     guide treatment decisions. Gathering HRQOL, local-regional recurrence (LRR) and survival data     in a prospective fashion is thus critical in this population. Therefore, we designed a     prospective trial to evaluate the outcomes for FTCWR in terms of LRC and HRQOL, and     short-term morbidity and mortality, with secondary focus on potential long-term overall     survival benefit.   "
1569|NCT03265340|"     Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS)     dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate     to severe MDD without concurrent medication will be randomised to three different treatment     protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.   "
1570|NCT03265327|"     This study will investigate the effectiveness of two oral supplements on the ocular signs and     symptoms in symptomatic dry eye patients. Eligible participants will be given one of two oral     supplements to take once a day for up to three months.   "
1571|NCT03265314|"     Alternatives For Girls (AFG) is offering LeadHer as a gender-specific teen pregnancy     prevention curriculum to girls between the ages of 14-19 years old who live in Wayne County,     MI. The curriculum seeks to demonstrate that girls who participate in LeadHer will show     increased rates of avoidance of unprotected sex, will show increased use of birth control and     reduced rates of pregnancy. LeadHer will run over a 6-session period covering topics designed     to prevent teen pregnancy and develop girls into leaders. The sessions will be co-led by     youth (Peer Educators).   "
1572|NCT03265301|"     With the ongoing developments in the field of hysteroscopy during the past 15 years,     hysteroscopic surgery is becoming safer and less invasive for the patient. Improved     technology has enabled surgeons to perform many operative procedures in an ambulatory setting     without significant patient discomfort and with potentially significant cost savings.      Office operative hysteroscopy (see and treat hysteroscopy) reduces the distinction between a     diagnostic and an operative procedure, shifting the focus in health care away from inpatient     diagnosis and treatment. The development of smaller-diameter hysteroscopes with     continuous-flow system features and working channels, through which operative instruments can     be introduced, has made it possible to treat some uterine and cervical diseases without the     traditional need for cervical dilation or general anesthesia.      Use of specially designed hysteroscopic 5F mechanical instruments (e.g., scissors, biopsy     cup, graspers, and corkscrews) has long been the only way to perform operative procedures in     an ambulatory setting. However, although grasping forceps and scissors are excellent for     treating adhesions, cervical polyps, and endometrial polyps smaller than or the same size as     the larger endometrial polyps, or thick lesions (e.g., submucous fibroids) were difficult to     treat successfully using such miniature, fragile instruments and without cervical dilation.      An important technologic advance occurred in 1997 with the introduction of a versatile     bipolar electrosurgery system dedicated to hysteroscopy, the Gynecare VersaPoint (Ethicon,     Inc., Somerville, NJ, USA), which represents a key point in the history of office operative     hysteroscopy. With the use of 5F bipolar electrodes, the number of pathologic conditions     treated using office operative hysteroscopy has increased tremendously, reducing the use of     the resectoscope and the operating room to a smaller number of cases.      More recently, a new generation of electrical generators, allowing the use of bipolar energy     on miniaturized electrodes, has been presented (Autocon 400 II; Karl Storz Endoscopy,     Tuttlingen, Germany). The main advantage of these instruments is that they are reusable,     thereby reducing the costs of office operative as those described for the Versapoint system.      The feasibility of ambulatory uterine surgery is not just dependent on recent technological     advances in instrumentation such as miniaturization of equipment, but also the favorable     anatomical characteristics of the uterus itself. The sensitive innervations of the uterus     originate in the myometrium and extend to the outer serosal surface, whereas the endometrium     and any fibrotic tissue within the cavity are less sensitive. Thus, procedures can be carried     out without the use of analgesia or anesthesia.      However, a careful operative technique is of paramount importance, in particular, avoiding     inadvertent deep penetration of the superficial myometrium when resecting lesions such as     polyps, maintaining the lowest possible distension pressures, and expediting procedures     through efficient surgical techniques.   "
1573|NCT03265288|"     An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the     safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.   "
1574|NCT03265275|"     At our institution, hip fracture patients are admitted and treated according to a fast track     patient pathway. The aim of this study is to identify areas of this patient pathway that can     be improved. To achieve this, the study will investigate the underlying reasons for the     continued need for hospitalization on the consecutive days after hip fracture surgery.   "
1575|NCT03265262|"     Background: The need for an oral food challenge (OFC) surrogate is growing in line with the     continuous increase in the prevalence and severity of paediatric food allergy. The basophil     activation test (BAT) has recently been reported as a promising tool for predicting the     outcome of OFC in children.      Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy     diagnosis and spare part of current OFC in paediatric patients attending allergy departments     in Marseille APHM University hospitals.      Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC     during a diagnostic or follow-up procedure.      Expected results: Good concordance of BAT and OFC results leading to potential OFC     replacement by BAT in at least 50% of the study population   "
2162|NCT03257605|"     The aim of this study is to evaluate and describe the feasibility of implementing a     pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly     (PACE), a community-based practice setting.   "
1576|NCT03265249|"     Auricular neurostimulation is a potential novel and non-invasive method of pain control     following liver transplantation in a growing patient population with the probability of     significant impact on economics and morbidity. The investigator propose a pilot study to     investigate the effects of auricular neurostimulation in patients receiving a liver     transplantation. The investigator will investigate the effects of auricular neurostimulation     with this novel device and compare it to the current standard of care for pain management     following liver transplantation.   "
1577|NCT03265236|"     The aim of this work is to evaluate the diagnostic value of anti-MCV antibodies in rheamatoid     arthritis patients and to correlate its relationtion disease activity and manifestations.   "
1579|NCT03265210|"     Chronic pain and depression frequently co-exist in late and mid-life and contribute to     increased disability, high health care costs, psychiatric comorbidity, and suicide. The     investigators will recruit 60 adults from two randomly assigned large WCMA primary care     practices; one practice will offer Relief (a 9 session behavioral intervention) and the other     will offer referral for mental health care.   "
1630|NCT03264547|"     To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar     PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent     HER2-positive breast cancer patients who have no medical history of chemotherapy except     ado-trastuzumab emtansine   "
1580|NCT03265197|"     Importance; Tinnitus is a heterogeneous diagnosis that may occur alone, in the presence of     hearing loss or as a component of other disorders and can be quite disabling. Intratympanic     injections of medications recently proved to have role in management of tinnitus. The     investigators report on our experience with the use of intratympanic injection of Lidocaine     as local anesthetic which potentiate the action of dexthamesasone in treatment of tinnitus     without adding potential risks of inner ear Objective; to describe the effect of Lidocaine as     local anesthetic may potentiate the action of dexthamesasone intratympanic injection in     treatment of tinnitus without adding potential risks of inner ear Design, Setting,     participants ; For this single tertiary center( Tanta University Hospital ) prospective case     series, the investigators included 44 patients divided into two groups (A and B) 22 patients     in each group suffering from tinnitus between March 2015 and October 2015 Intervention; Under     local anesthesia 22 patients were subjected to intratympanic injection with combined     Lidocaine 2% and dexamethasone with ratio (1:1), in the group A, and 22 patients in the other     group B were subjected to intratympanic injection with dexamethasone only , this process was     repeated 3 times for 3 successive weeks.      Main Outcome and Measures; the primary outcome is self-reported significant improve in     tinnitus in group A more in group B without adding significant damage of inner ear   "
1581|NCT03265184|"     Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2     diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and     low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA)     which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this     trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and     vascular inflammation in patients having Mets   "
1582|NCT03265171|"     These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV     infusion in one adult and one child with hypoplasminogenemia. These patients are under     treatment to address wound healing and obstructions.   "
1583|NCT03265158|"     To determine whether peripheral blood flow cytometry can reduce or replace invasive bone     marrow examinations in patients with slow growing lymphomas.   "
1584|NCT03265145|"     The primary objective of this pragmatic study is to compare the time to first moderate or     severe COPD exacerbation in patients, not controlled on their current therapy, randomized to     Stiolto Respimat versus triple therapy over 12 months of treatment      The secondary objectives of this study include:        1. To compare the annual rate of moderate or severe COPD exacerbations for patients on          Stiolto Respimat with patients on triple therapy.        2. To compare the time to first severe COPD exacerbation in both treatment arms.        3. To compare the annual rate of severe COPD exacerbations in both treatment arms.        4. To compare the proportion of patients with moderate or severe COPD exacerbations in both          treatment arms.   "
1585|NCT03265132|"     The aim of this study is to demonstrate the efficacy and to evaluate the safety,     pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's     disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset     Still's disease).   "
1586|NCT03265119|"     This is PART A of a 3-part, 6-week, double-blind, dose-optimization, parallel-group study in     children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes     implicated in glutamatergic signaling and neuronal activity. Parts A will include subjects     determined to have a specific gene mutation(s) implicated in glutamatergic signaling and     neuronal activity.   "
1587|NCT03265106|"     This is a single arm, open-label, uni-center, phase I/II study to determine the safety and     efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell     acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic     SCT, or are otherwise ineligible for allogeneic stem cell transplant.   "
1595|NCT03265002|"     The aim of the study is to investigate how dietary fibre combinations affects gut physiology,     particularly colonic gas production. Comparisons will be made between a single fermentable     fibre (inulin), a non-fermentable fibre (psyllium) and a combination of the two. The study     will also explore differences in response between diarrhoea-predominant and     constipation-predominant IBS (IBS-D and IBS-C) respectively.      The participants will have a preliminary meeting to ensure they are eligible, then will     attend the MRI department on 4 occasions separated by at least 1 week. They will ingest a     drink with the fibre product mixed in, and will have 8 MRI scans (each lasting approximately     15 minutes).   "
11352|NCT03137303|"     The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic     Error in COPD and Asthma patients.   "
1588|NCT03265093|"     Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis,     immunity and epithelial proliferation phases. over a decade has since past since PRF was     developed and many clinicians now point to the potential use of a liquid version of PRF. a     liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation     forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the     fibrin coagulation could be slowed down at early time points thus generating an injectable     PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further     able to stimulate growth factor release.      Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect     s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for     the treatment of OLP are suggested. However, long      -term use of corticosteroids may be associated with local and systemic complications, and     moreover, some patients may not be responsive.      We aimed to apply a treatment of autogenous origin (including no foreign products),     considering the side effects of our corticosteroids. The study was designed as a split mouth.      We planned to administer I-PRF to one side and intralesional corticosteroid therapy to the     other side at patients with bilateral atrophic / erosive oral lichen planus lesions   "
1589|NCT03265080|"     This is a phase 1, open-label, uncontrolled, multicenter study in 3 distinct solid tumors.     The study design is dose-escalation/de-escalation using a standard 3 + 3 design to evaluate     the safety profile of ADXS-NEO, to select a recommended phase 2 dose (RP2D), and identify     initial signs of clinical activity in each of the 3 tumor-specific cohorts.   "
13394|NCT03110107|"     The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in     combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors   "
1590|NCT03265067|"     This is a before and after observational study of a therapeutic strategy to treat patients     with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning     (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the     purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation     of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC®     Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada     for this use under the direction of a health care professional. Paramedics in the Peel and     Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic     Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and     study data will be collected from existing patient records.      The 'before' group will include up to 900 patients who were treated before autoRIC     implementation in the services and hospitals. These patients would have had a STEMI and     undergone PCI, but did not receive the autoRIC device. The 'after' group will include up to     900 eligible patients who have had RIC treatment with the autoRIC device at the two     participating sites following implementation in the services and hospitals.      The primary analyses will compare the short-term and long-term outcomes of eligible patients     who have received completed primary PCI for STEMI in the time period before the     implementation and following the implementation of this RIC strategy. In addition, a health     economic analysis will be conducted to determine the cost-effectiveness of the therapeutic     strategy to treat STEMI patients with RIC prior to PCI.   "
1591|NCT03265054|"     Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE)     affects about 1,200,000 individuals each year in Europe. About 50% of VTE are unprovoked and     20% of these patients will face a recurrent event after the usual three to six‐month course     of anticoagulant treatment. To date, most patients are given prolonged anticoagulant     treatment. However, anticoagulant treatment are associated with a major risk of bleeding     (3%/year). Thus an accurate identification of patients with unprovoked VTE with a low risk of     recurrence is needed to avoid unnecessary anticoagulant treatment with a risk of bleeding.      Over the past few years, microparticles (MPs) which are small vesicles originating from the     budding of cellular membranes have emerged as important biological entities regulating     hemostasis. MPs expose at their surface procoagulant molecules such as phosphatidylserin and     tissue factor (TF). All data obtained in mouse models support a role of MPs in venous     thrombosis mediated by the TF activation. Moreover, results from clinical studies showed that     TF-MPs was associated with the risk of venous thrombosis. However, the predictive value of     TF-MPs in the recurrence of VTE is unknown. Besides, no study has taken into account the     recent progresses in the understanding of the role of MPs in haemostasis. Indeed, MPs     vectorize molecules which are not only procoagulant but also profibrinolytic. The net result     depends on a balance between both activities (the coagulo-lytic balance). This balance is can     be measured by two complimentary assays on MPs.      We hypothesized that the coagu-lytic balance of MPs is associated with an increased risk of     VTE recurrence after stopping the anticoagulant treatment.   "
1592|NCT03265041|"     To detect and evaluate the predictors of graft patency after coronary artery bypass graft     surgery as assessed by multi-slice CT coronary angiography validated by coronary angiography   "
1593|NCT03265028|"     Antibiotic resistance is a worldwide health care problem. Increasing use of antibiotics is     associated with an increase in the prevalence of bacteria resistant to the antibiotic used.     Reducing antibiotic use can be effected by improving antibiotic prescribing quality in two     complementary ways. One is to limit antibiotic prescribing to those patients who will benefit     from the treatment and two is to prescribe these patients the recommended antibiotic.      International research has shown that a web-based communication training for the prescriber     combined with an interactive booklet containing relevant patient information (GRACE INTRO)     can significantly and safely reduce antibiotic prescribing in adults presenting to primary     care with acute cough/lower respiratory tract infections (LRTI). Quality assessment of     antibiotic prescribing for respiratory infections in general practice has revealed the use of     far too many (broad-spectrum) antibiotics in Belgium.      In the proposed project, we aspire to make Belgium the first European country to implement     the most cost-effective part of the GRACE INTRO intervention (TRACE e-learning,     www.acutecough.org) at national level and to perform a scientifically sound assessment of the     nationwide implementation on outpatient antibiotic use and societal cost.   "
1594|NCT03265015|"     This project seeks to identify causal neural mechanisms underlying unwanted, repetitive     behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a     computer task, we will modulate activity in a target brain region in two directions (up or     down) and measure effects on compulsive behaviors and related measures. This work could     ultimately lead to the ability to treat compulsions more effectively by targeting the regions     of the brain that can help or hinder attempts to overcome compulsions.   "
1596|NCT03264989|"     The purpose of the CSEG101A2202 study is to characterize the PK and PD of SEG101 at 5 mg/kg     and to evaluate the safety and efficacy of SEG101.      Study CSEG101A2202 is designed as a Phase II, multicenter, open-label study. Up to 45     patients (to identify 27 evaluable patients) will be enrolled to the treatment group     crizanlizumab 5.0 mg/kg to complete full PK/PD sampling at week 1 and week 15. In all     patients, trough PK/PD samples will also be collected prior to each dose. In addition,     throughout the study (and when possible), all patients will have blood drawn for serum to     assess PK and PD drawn at times of onset and resolution of each VOC event, fever, or     suspected infection. Once the up to 45 patients are enrolled, 10 additional patients will be     enrolled to the exploratory treatment group and begin at 7.5 mg/kg of crizanlizumab.   "
1615|NCT03264742|"     Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the     patients are included in the study and treated according to the concept on the Stroke Unit     within the complex treatment. The patients are included after clarification and with the     consent of the patients. On the morning after the day of intake, the first determination of     the ghrelin takes place in the routine blood sampling. Similarly, 48 hours later and 3 months     after the stroke, a blood sampling is performed to determine ghrelin. The De Morton Mobility     Index (DEMMI), the 9-hole-peg assay and the modified Rankin Scale (mRS) are determined on the     day of admission, on the 3rd day, and three months after stroke. This is done within the     framework of the routine clarification and treatment on the Stroke Unit.   "
22204|NCT02995109|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
1597|NCT03264976|"     Diabetic retinopathy (DR) is one of the most common causes of blindness worldwide. It is a     progressive disease and its detection in early phases is very crucial for visional outcomes.     miRNA of exosomes has been recently considered as a potential circulating marker of     oculopathy, including age-related macular degeneration and uveal melanoma. Therefore, the     primary objective of this study is to evaluate whether the serum exosomal miRNA could be     prospective prognosis biomarker to investigate the initiation and development of DR. This     case-control study is planned to include diabetic patients, and patients without DR, which     serve as controls. Other participants will be divided into four groups by different DR stages     according to the guideline from AAO. Information and samples of all trial participants will     be collected at the inception of the study, including basic information, medical history,     serum samples, and several ophthalmologic examinations. Then these information and     examinations will be collected at regular intervals: every 12 months until 5 years. Different     statistical methods will be used to identify significant associations between DR progression     and different exosomal miRNA. We hypothesis that there could exist alert level of exosomal     miRNAs which indicate the onset and development of DR in diabetic patients. Moreover, the     selected exosomal miRNAs, being considered together with other information including medical     history, blood indicators and ophthalmologic examinations, to be chosen-optimized as a     prognostic model for DR, which may help predicting high risk groups of DR and those with poor     prognosis. Based on clinical trial data, we will further discuss about possible roles of     identified miRNA of exosomes in the pathogenesis of DR.   "
1598|NCT03264963|"     The objective of this study is to reduce the incidence or intensity of snoring in a patient     population of known simple snorers without sleep apnea using smartphone based application     which allows participants to play voice controlled games using various articulations     resulting in tongue base movements.   "
1600|NCT03264937|"     This is a prospective, observational, randomized controlled trial   "
1602|NCT03264911|"     Evaluate the necessity to treat with antibiotics GAS pharyngitis in children in Switzerland.     The null hypothesis is that antibiotic treatment is not necessary for GAS pharyngitis in this     population.   "
1603|NCT03264898|"     Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United     States population is not up-to-date with screening. Although 90% of colorectal cancer     screening is done using colonoscopy, most other countries use fecal immunochemical tests,     reserving colonoscopy for those with a positive fecal immunochemical test. This project will     provide the foundation for a paradigm shift for colorectal cancer screening in the United     States by identifying how well 5 different FITs work for detecting screening relevant     neoplasia, thus reducing morbidity and mortality for colorectal cancer.   "
1604|NCT03264885|"     Elderly with visual impairment (VI) who undergo community eye screening often do not attend     tertiary follow-up even if significant eye diseases are detected. Investigators evaluate an     incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits of     participants following community eye screening.   "
1605|NCT03264872|"     The main purpose of this project is to test whether Peer-Enhanced Motivational Interviewing     (PMI) results in superior alcohol and marijuana use outcomes for emerging adults (EAs, ages     18-29) and their peers. Ninety peer dyads (total n = 180, ntarget client = 90, npeer = 90)     are randomized to receive either Peer-Enhanced Motivational Interviewing (PMI) or Waitlist     Control (WC).   "
1606|NCT03264859|"     The aim of this study is to investigate the association between NGAL plasma levels in     ST-elevation myocardial infarction and the no-reflow phenomenon, adverse events during     hospitalization and at 30-day follow-up.   "
1633|NCT03264508|"     This study aims to determine the effects of 8-10 weeks of repeated hot water immersion (heat     therapy) vs. thermoneutral water immersion on vascular function in late middle-aged to older     (55-79 years) adults.   "
4536|NCT03226470|"     This is an open-label and triple cohort study of the safety and efficacy of T27 and T512 to     possibly treat cervical intraepithelial neoplasia(CIN).   "
1608|NCT03264833|"     Purpose The purpose of this feasibility study is to assess the accuracy and precision of the     Temp-Traq thermometer for monitoring body temperature in adult patients under three     conditions (hypothermia, normothermia, and hyperthermia).      Specific Aims        1. To assess the accuracy of the Temp-Traq thermometer as compared to a gold standard (Core          temp measured by Pulmonary Artery Catheter)        2. To assess the precision of the Temp-Traq thermometer over repeated measures        3. To determine if accuracy &/or precision is consistent in three conditions (hypothermia,          normothermia, or hyperthermia)   "
1609|NCT03264820|"     At the digital level, the diagnosis of obstructive arteriopathy is very difficult in the     absence of ulcer or of true ischemic signs, and the arteriography, which is an examination to     inject an intra-arterial contrast agent, is the reference measure.      The measure by Laser Doppler uses a monochromatic light (laser) to measure the     concentration as well as the speed of travel of red blood cells in the skin and deduct the     cutaneous blood flow.      The great advantage of this technique is that it is non-invasive, inexpensive and can be     performed during a consultation. The patient can therefore be briefly informed of the benign     (functional) or organic origin of his disorders.   "
1610|NCT03264807|"     The purpose of this study is to compare the survival rate according to the presence or     absence of 14v lymph node dissection.   "
1611|NCT03264794|"     1. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet          (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability          of comparative studies which examine people in vivo pharmacokinetic behavior, provide          the basis for clinical use.        2. Evaluation CTTQ gefitinib imatinib sheet production efficacy and safety of Chinese          patients with locally advanced or metastatic non-small cell lung cancer.   "
1613|NCT03264768|"     This a single center non-randomised non-sham controlled intervention study evaluating the     effectiveness and safety of endoscopic lung volume reduction by endobronchial valves   "
1614|NCT03264755|"     Cortical excitability and role of repetitive transcranial magnetic stimulation in nicotine     use disorder. Estimation of cortical excitability in heavy smoker patients and determination     of role of repetitive transcranial magnetic stimulation for reducing nicotine craving.   "
11781|NCT03131687|"     The purpose of this study is to evaluate the efficacy of the study drug LY3298176 in     participants with type 2 diabetes mellitus.   "
1617|NCT03264716|"     Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause     of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year     approximately 60% will develop liver metastasis during the course of their disease. In     approximately 30% of these patients who develop liver metastasis the metastatic disease will     remain confined to the liver.      For the 70-75% of colorectal patients with colorectal liver metastasis not suitable for     hepatic resection or similarly ablative therapy with curative intent, systemic chemotherapy     is the standard initial management. However, after a patient has failed first- line and in     some cases second-line chemotherapy, response rates fall to as low as 12% (Chen HX 2006).     Transarterial chemoembolization (TACE) with microsphere is an alternative treatment because     normal liver tissue receives most of its blood supply from the portal vein, while colorectal     liver metastases derive most of their flow from the hepatic artery. Several clinical trials     have explored the feasibility and the efficacy of TACE with microsphere as a treatment for     patients with colorectal liver metastasis. HepaSphere represents a novel drug delivery system     for chemoembolization, which can add two benefits to embolization therapy. First, by     ionically binding the doxorubicin throughout the microspheres, more drug can be delivered     into the tumor, with less escape into peripheral circulation. Second, conformability to the     architecture of the vessel lumen, providing more contact surface area with the embolic     material and the vessel intima, leading to a more complete occlusion. However, there are     limited experiences in using HepaSphere TACE for colorectal liver metastasis in Taiwan. In     this pilot study, we will evaluate the initiate safety and efficacy of Hepasphere     microspheres loaded with a chemotherapeutic agent doxorubicin for the treatment of patients     who have failed first-line and second-line systemic chemotherapy.   "
1618|NCT03264703|"     This study will be conducted to observe the disease activity change of Conventional Disease     Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from     baseline to 6 months compared with cDMARDs, as measured by the disease activity score with     the erythrocyte sedimentation rate (DAS28-ESR).   "
1619|NCT03264690|"     This study will be conducted to observe the difference in microbiome composition between     healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor     necrosis factor (anti-TNF) treatment.   "
1620|NCT03264677|"     -  To investigate the product regiments' performance on moisturization related skin healthy          signs (skin moisturization, barrier function, elasticity, translucency, roughness and          skin conditions) through instrumental evaluation, clinical grading and self-assessment          before, during and after 8 weeks' home usage under city environmental aggressors (Sun,          change of temperature and humidity, wind and air pollution) among 3 product regimens and          Non-treatment control;        -  To explore the linkage among products efficacy, ambient aggressors, and life habits;        -  To investigate product regimens' tolerance and safety via Home Use Test;        -  To collect skin microflora/microbiome samples for potential research on skin microbiome          distribution change as impacted by product application and/or environmental aggressors          change (data will be analyzed and reported separately).   "
1621|NCT03264664|"     This study will be conducted to assess the safety/tolerability profile of E7386 as a single     agent administered orally in participants with selected advanced or recurrent neoplasms and     to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of     E7386.   "
1622|NCT03264651|"     To evaluate the impact of a selective androgen receptor modulator combined with an aromatase     inhibitor in reducing high mammographic breast density.   "
1623|NCT03264638|"     This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the     combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in     adults women. One third of participants will receive Dingkundan capsules, one third of     participants will receive Diane-35 Pills, and the another third will receive Dingkundan     capsules and Diane-35 in combination.   "
1624|NCT03264625|"     This is a pilot randomized, controlled trial of Vitamin D supplementation in patients on     peritoneal dialysis and to explore if oral administration of vitamin D3 could reduce the risk     of subsequent Peritoneal dialysis-related (PD-related) peritonitis and improve the prognosis     of peritonitis      Aims of the study are to:        1. To examine the effect of vitamin D supplementation on the risk for peritonitis among          patients on peritoneal dialysis.        2. To explore the effect of vitamin D supplementation on the prognosis of peritonitis.   "
1625|NCT03264612|"     Each female sets her experience of 47 manifestations on a 6 point scale separately for the     premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.     Daily Symptoms Report was filled at the start and at end of the study (before and after     performing swimming exercise) Females in group I were instructed to engage into swimming     exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3     days of menstrual cycle then resumed afterwards.      The exercise included three stages: warming up, swimming and cooling down.   "
1626|NCT03264599|"     2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is     occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the     fetal head and upper spine was acquired and stored in the ultrasound machine. On this image,     the offline measurement of the angle formed by a line tangential to the occipital bone and a     line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will     be performed to quantify the degree of fetal head flexion in respect to the trunk   "
1627|NCT03264586|"     Included women were divided randomly into two groups:      Group A: (n=100): women were subjected to application of EMLA® cream Lidocaine-prilocaine     cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and     2.5% prilocaine)for pain relief during episiotomy repair.      Group B: (n=100): women were subjected to application of local injection of 10 ml of 1%     mepivacaine for pain relief during episiotomy repair.   "
1628|NCT03264573|"     The Objectives of this randomized controlled trial aiming to establishing a protocol of post     scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem     cell injection in improvement of atrophic scar after scar revision.   "
1629|NCT03264560|"     There is a critical shortage of psychiatric services to people with mental illness who live     in Skilled Nursing Facilities (SNFs), especially those in rural settings. Although real-time     video conferencing psychiatric consultation, termed Synchronous Telepsychiatry (STP), has     been around for almost 3 decades, its adaptation is met with logistic and other challenges.     In this context, the investigators investigate a novel method of psychiatric consultation     termed Asynchronous Telepsychiatry (ATP). The main hypotheses are that that ATP will be as     clinically effective as STP, and that it will be acceptable to patients. This study aims to     evaluate the comparative clinical effectiveness of ATP vs. STP in SNF population, in a     12-month non-inferiority, randomized, controlled trial.   "
3885|NCT03235024|"     This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II     trial, comparing the effect of twice daily B244 application for 28 days vs vehicle     application on treatment of mild to moderate AD   "
1631|NCT03264534|"     Astigmatic keratotomy (AK) is used to treat numerous refractive disorders, including     congenital astigmatism, residual corneal astigmatism at the time of or following cataract     surgery, post-traumatic astigmatism, and astigmatism after corneal transplantation.      Within the past few years, much consideration has been given to an evolutionary variant of     the procedure, the limbal relaxing incision (LRI). By moving the incision farther to the     periphery, cataract surgeons can safely and predictably remediate mild to moderate amounts of     regular astigmatism at the time of cataract surgery by performing this incisional technique.      Recent technological developments have shifted ophthalmologist's attention from manually     created LRIs and astigmatic keratotomy procedures to femtosecond laser-guided procedures.     Femtosecond lasers offer superior incisional accuracy and reproducibility coupled with     minimal effects on collateral tissues, achieving levels of safety and reproducibility     exceeding those of mechanical techniques. A major clinical application of the femtosecond     laser is for creating arcuate incisions that have a precise and accurate length, depth,     angular position, and optical zone.   "
1632|NCT03264521|"     The study aims to advance pain research by exploring feasibility of crowdsourcing patient     pain data via Amazon Mechanical Turk, the largest and most studied crowdsourcing platform in     the U.S. We will leverage an existing NIH/NCCIH grant as a comparison data (RAND Center of     Excellence in Research on CAM; CERC) to conduct a feasibility study of new methods for     gathering and analyzing data on chronic pain and engaging pain patients in health policy.   "
31795|NCT02869568|"     Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer   "
1634|NCT03264495|"     The objective of the study is to measure the quantities of food consumed at each meal by a     representative part of the population of patients hospitalised in each department of the     Champmaillot Geriatric Centre.      To do so, the quantity eaten will be quantified by weighing the amounts served and     subtracting the weight of the left-overs. These measurements will allow us to provide more     appropriate meals in the second step.   "
1635|NCT03264482|"     the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front     fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a     prospective randomized trial.   "
1636|NCT03264469|"     Psychological trauma is a major public health concern that affects numerous patients who have     experienced traumatic events.      The objective of our research was to improve the diagnosis and management of persons     experiencing such events.      We will seek to determine factors brought into play in the construction of psychological     trauma and the best way to identify them so as to implement the optimal management of     patients and ensure recognition of this condition.      In addition, in the context of our activity as expert witnesses, we will study the methods     used to assess and quantify psychological trauma.      In this respect, a medical appointment will be made by a nurse of the Forensic Medicine     Department of Dijon CHU. During this consultation, a self-report questionnaire will be     completed by the patient alone to evaluate the level of acute stress followed by a     psychiatric consultation and completion of the IES-R questionnaire with the doctor to     identify symptoms of psychological trauma.   "
1637|NCT03264456|"     There is great need for improved preoperative imaging in men with high-risk prostate cancer.     Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for     local, regional and whole body preoperative staging in a single imaging session using the     amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of     prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently     problematic. Conventional imaging is falsely negative for regional lymph node metastases in a     substantial fraction of men. In particular, approximately 35% of men with high-risk prostate     cancer will have biochemical recurrence even after optimal surgical resection. A major     benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18     fluciclovine PET includes having the patient undergo a single imaging study which provides     both anatomic and molecular characterization of the tumor, including metastases which would     potentially be missed by conventional anatomic imaging and size criteria. Additionally,     simultaneous acquisition will improve co-registration of the PET and MR data which is     valuable for small lesions and in anatomically complex regions. Although the use of     fluciclovine in the characterization of the primary PCa remains to be established, the     anatomic detail provided by conventional mpMRI will complement the detection of small volume     metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology     allows for the assessment of dynamic tracer uptake and washout during the whole body and     regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary     PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect     nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology     to develop new treatment algorithms for the optimal management of these patients.   "
1638|NCT03264443|"     Two-center randomized, parallel, controlled trial which will compare a pragmatic combined     training program with a health education program in 184 older adults with hypertension. This     study will last 12 weeks with assessments conducted at baseline, previously to the group     allocation, and after interventions. There is a set of secondary outcomes which show clinical     importance to the elderly population and are possibly influenced by the tested intervention.   "
1640|NCT03264417|"     A multicentric study to explore variability when clinicians are intrepreting lung function     tests. Comparison with results of in-house built software for automatic interpretation.   "
1641|NCT03264404|"     The purpose of this study is to determine the effectiveness of combining immune therapy,     pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who     have advanced pancreatic cancer with disease progression on first-line therapy are usually     treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy     regimen and national guidelines recommend chemotherapy or clinical trial participation. In     this study, all study subjects will receive a combination of immune therapy (every 3 weeks)     and a hypomethylating agent (every 4 weeks).To date, studies have shown that combining a     hypomethylating agent with chemotherapy or immune therapy may benefit patients across     different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of     pancreatic cancer demonstrates improvement in survival with the combination of a     hypomethylating agent and immune therapy. However, the use of single agent hypomethylating     agent or immune therapy has not been shown to be effective in patients with pancreatic     cancer. The one exception, to date, is the use of immune therapy in those individuals with a     particular genetic feature known as mismatch repair deficiency and microsatellite     instability. The combination of immune therapy and a hypomethylating agent has not been     studied in human subjects and is not approved by the FDA for use in pancreatic cancer.      This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in     subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31     individuals will be asked to participate in this study.      Primary objective: To evaluate the progression-free survival per RECIST 1.1.      Secondary Objectives:        1. Safety Objective: To determine the safety and tolerability of induction therapy with          azacitidine followed by pembrolizumab in advanced pancreatic cancer.        2. To evaluate the objective response rate (ORR), duration of response (DOR), disease          control rate (DCR), and time to progression (TTP) per RECIST 1.1, and overall survival          (OS).   "
1685|NCT03263832|"     This is an observational study that does not change routine care.      The primary objective of this study is to investigate the correlation between the     administration of an antibiotherapy able to prevent biofilm formation according to the     results of the Antibiofilmogramme test, and the relapse of the infection for patient with     orthopaedic device-related infection.   "
3886|NCT03235011|"     Evaluation of knowledge about contraception in sickle cell adolescents.   "
1642|NCT03264391|"     Behcet's disease is an important cause of retinal vasculitis and vision loss in Egypt.     Fluorescein angiography is the standard method of diagnosis of retinal vasculitis. OCT     angiography (OCT-A) is a recently developed method that can be used in the evaluation of     retinal circulation. In this study, we will test the utility of OCT-A in diagnosis and follow     up of retinal vascular changes in cases diagnosed with Behcet's disease that visit the     outpatient uveitis clinic of Assiut University hospital, a major tertiary center in southern     Egypt, over a one year duration. Also, correlation of OCT-A changes with visual acuity and     hence prognosis will be described.   "
1643|NCT03264378|"     The Partnership in Implementation Science for Geriatric Mental Health (PRISM) project     proposes an evidence-based physical exercise intervention for older adults who exhibit     behavioral and psychological symptoms of dementia (BPSD). The proposed evaluation study will     conduct a randomized controlled trial with a Hybrid Type 3 design to compare the intervention     arm that implements the culturally-adapted GTO model (GTO-ThAI) to deliver implementation     support, with a control arm, which receives usual top-down administrative instruction for     implementing a policy initiative.   "
1644|NCT03264365|"     Relatives of intensive care patients are at risk of developing symptoms of anxiety,     depression and post-traumatic stress disorder resulting in impaired health-related quality of     life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The     hypothesis is that relatives to former intensive care patients will improve their HRQOL one     year after intensive care. We want to determine whether relatives to former intensive care     patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC)     and symptoms of anxiety, depression and PTSD compared to standard care one year after     intensive care.   "
2714|NCT03250377|"     The purpose of the study is to evaluate the long-term safety and tolerability of BRV in focal     epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV     over time.   "
1645|NCT03264352|"     Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse     cardiovascular (CV) events. Diabetic patients with hypertension benefit from BP lowering     treatment. The present trial,IPAD in brief, is a randomized, double-blind,     placebo-controlled, parallel-group, multicenter study involving 12,000 patients to be     recruited over three years and to be followed up for a median of three years and a half. IPAD     tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose     seated BP 130-149 mm Hg systolic and below 90 mm Hg diastolic, results in 35% difference in     the incidence of stroke. During follow-up the sitting systolic pressure should be decreased     both by at least 10 mm Hg and lower than 130 mm Hg, by titration and combination of the     double-blind study medications of an angiotensin type-1 receptor blocker Allisartan (240     mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and a     hydrochlorothiazide (12.5-25 mg/day). In the placebo group, identical tablets will be used     similarly.   "
1646|NCT03264339|"     Children with cerebral palsy (CP) have life-long motor disorders caused by brain injuries     which occur around birth. These children go through extensive treatment during childhood, but     the treatment has generally been started late due to late diagnosis (median age 15 months).     New recommendations state that the clinical diagnosis high risk of CP should be given     before 6 months corrected age, in order to be able to intervene as early as possible, and     have the best possibilities to prevent or limit the adverse neurodevelopmental consequences     of brain injuries occurring around birth. Thus, there is a great need to develop     evidence-based early interventions for children at high risk of developing cerebral palsy.      The Small Step program is developed at Karolinska Institutet (KI) in Stockholm, Sweden and is     based upon theories of brain plasticity induced by early learning. The efficacy of the     program is presently being investigated at KI. Preliminary results indicate a large     individual variation in response to the program among the participating children.      The aim of the present study is therefore to explore individual responses to the Small Step     Program in infants at risk of developing cerebral palsy.      The main hypothesis is that infant characteristics, such as severity of brain pathology, are     associated with differential response to the program. Also, infants with absent fidgety     movements and children with sporadic fidgety movements are believed to respond differently to     the program.   "
1647|NCT03264326|"     The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to     assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training     in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional     self-report, and objective functional measures. SWE will be utilized to objectively quantify     tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles     tendinopathy.   "
1648|NCT03264313|"     The intent of the study is to evaluate the efficacy and safety of dTMS used as a tool for the     smoking cessation; therefore, the subjects will be randomized to be treated on the active     group or to receive placebo stimulation.   "
1649|NCT03264300|"     A critical aspect of brain tumor patient management is the radiographic assessment of tumor     status, which is used for diagnosis, localization, surgical planning and surveillance. The     primary goal is to develop and apply advanced, quantitative magnetic resonance imaging (MRI)     techniques that can supplement existing high-resolution anatomic imaging to aid clinical     decision-making for patients diagnosed with brain tumors. The studies proposed herein involve     the development of advanced imaging methods that are intrinsically sensitive to the     biophysical characteristics associated with tumor pathogenesis, as they are more likely to     improve tumor characterization and localization and may offer early and more specific     indicators of treatment response. These advanced methods include diffusion-weighted imaging     (DWI), chemical exchange saturation transfer (CEST), and dynamic susceptibility contrast     (DSC) perfusion MRI. A secondary objective of this study is to validate cerebral blood volume     (CBV) metrics acquired using a DSC acquisition and post-processing methods by comparison with     an intravascular reference standard contrast agent. Validated perfusion imaging techniques     will improve the reliability and relevancy of derived CBV metrics across a range of clinical     applications, including tumor localization, treatment guidance, therapy response assessment,     surgical and biopsy guidance, and multi-site clinical trials of conventional and targeted     brain tumor therapies.   "
1650|NCT03264287|"     This trial is designed to evaluate the efficacy of different frequencies in treating the     moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear     point tapping.   "
1652|NCT03264261|"     To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training     only on walking function in individuals post-stroke, a 6 week, single-blind, randomized     training study will be conducted with three assessments of gait to determine the training     effect. Subjects will be randomized to either the CIMT or treadmill training only groups at     the initial test. Following the initial test, individuals from the 2 groups will undergo     intensive locomotor training. Training will be performed 3 times per week for 6 weeks with     the training time for each visit set to 45 minutes as tolerated. Data collection will proceed     until 36 subjects from 2 groups have been trained.   "
1879|NCT03261310|"     The purpose of this study is to investigate the effectiveness of intravenous acetaminophen     (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery)     and spine surgery. Studies have shown that intravenous acetaminophen is useful for post     operative pain control in some operations but there have not been studies to evaluate the use     of acetaminophen in craniotomies or spine surgery.   "
37675|NCT02792504|"     To evaluate safety and efficacy of CE/BZA in real practice in Korea   "
1653|NCT03264248|"     The goals of the proposed study are to test the usability, feasibility and preliminary     efficacy of the E-Scale with wheelchair users. The E-scale was developed as a weight     monitoring technology for wheelchair users. Up to fifteen overweight or obese wheelchair     users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT)     for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g.,     goal setting, self-monitoring) to support lifestyle changes specifically for people with     mobility impairments. The subjects will also be provided the E-scale to track their weight     daily. The outcome measure include usefulness (subjective feedback from a survey about the     program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and     efficacy (improvements in weight and other measures of health) of the weight loss program     coupled with the E-scale at the end of 13 weeks. The primary hypothesis is that the E-scale     coupled with the weight loss intervention will result in significant improvements in weight,     abdominal girth, body fat percentage, and the Center for Epidemiologic Studies Depression     Scale (CES-D).The results may inform the refinement of this technology to increase its     applicability for wheelchair users to independently monitor their weight in their own homes     while attempting to lose weight.   "
1654|NCT03264235|"     Hypothesis/Specific Aims: The purpose of this research study is to determine if using an     exoskeleton during stair climbing training will result in an improved ability to walk and     climb stairs in individuals affected by recent stroke as compared to stair climbing training     without an exoskeleton.   "
1656|NCT03264209|"     This study aims to examine whether Smart After-Care service (Internet-and mobile-based     lifestyle intervention) has an effect on patients' satisfaction and clinical outcomes in     patients with prostate cancer on androgen deprivation therapy. Patients with prostate cancer     on androgen deprivation therapy will participate in the study. The study design is a     randomized controlled trial. The patients were randomly assigned to intervention or usual     care groups. Intervention patients received Smart After-Care service for 3 months. Primary     endpoint was an increase in patients' physical function as assessed using 2 minute walking     test. Secondary endpoints included improvement in muscle strength, short physical performance     battery, body composition, and health-related quality of life.   "
1657|NCT03264196|"     The condylar head is the part of the lower jaw which forms the joint. Displaced fractures of     this area are uncommon but can cause problems with function, such as chewing, if not treated     effectively. The medical literature does not have a clear consensus on whether these should     be treated operatively (with surgery to reduce and fix the fracture) or conservatively (with     advice and exercise and no surgery). The investigators propose a randomised controlled trial     comparing the outcome of the operative or conservative treatment of condylar head fractures     of the mandible, primarily with regards to patient related outcome measures of mandibular     function, and secondarily objective measures of mandibular movement, function and symptoms to     try and provide a clearer answer as to the best way of managing them.   "
1658|NCT03264183|"     Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and     diagnosis in the perioperative setting for critically ill patients and patients undergoing     cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography     (TTE) data and have not validated by transesophageal means. The aim of this study is to     validate TEE assessment of right ventricular function by comparing them to simultaneously     measured TTE measurements.      Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the     investigators will attempt to define a range of normal values of RV free wall strain as     compared to the other measures of RV function.   "
1659|NCT03264170|"     Intrauterine pregnancy of uncertain viability (IPUVI) affects 30% of women seen in the Early     Pregnancy Assessment Unit (EPAU). Such women have a pregnancy within the uterus on ultrasound     but do not meet ultrasound criteria to confirm an ongoing pregnancy. This may represent a     normally developing (early) pregnancy (50%) or a failing pregnancy ending in a miscarriage.     Following The National Institute for Health and Care Excellence (NICE) Guideline 154 (2012),     women need a confirmatory ultrasound after two weeks. This interval is particularly     distressing for women and diagnostic uncertainty in early pregnancy is associated with     heightened levels of anxiety and depression. NICE Evidence Update 71 (2014) suggests that     provision of more information about the likely outcome of the pregnancy (prior to the repeat     ultrasound) may benefit psychological health.      The investigators have previously developed, validated and published a mathematical model to     predict pregnancy outcome after diagnosis of IPUVI (1435 women studied). The model (which     takes account of maternal age, bleeding score and ultrasound measurements) is established as     an accurate research tool.      This study will evaluate whether providing women with an individualised prediction (as a     percentage) of the outcome of their pregnancy at the follow-up scan will help reduce symptoms     of anxiety and depression.      The study will take part in two phases. Phase I women will not receive the risk prediction     but will be invited to complete three questionnaires relating to anxiety and depressive     symptoms. Phase II women will receive the risk prediction (intervention) and will also be     invited to complete the same three questionnaires as the women in Phase I. The responses will     then be analysed once recruitment is complete.      Although the prediction model cannot change pregnancy outcome, establishing that it is     psychologically beneficial (and not harmful) may help up to 30% of the EPAU population.   "
1660|NCT03264157|"     A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of     the pharmacokinetics and safety (and tolerability) of simulated post-exposure prophylaxis     with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.   "
1702|NCT03263611|"     This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted     single injection of AMG0103 in subject with chronic discogenic lumbar back pain   "
33104|NCT02852460|"     To evaluate the influence of rapid recovery on sleep quality following total hip replacement     surgery   "
1673|NCT03263988|"     Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It     is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic     parameter of hemodynamic optimization. Until now standard methods for blood pressure     measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct,     continuous and invasive by inserting an intraarterial catheter. This observational study will     show, that a new non-invasive piezocapacitative-interlayer technology will make continuous     blood pressure monitoring and non-invasive pulse contour analysis available.   "
1955|NCT03260322|"     The primary purpose of this study is to evaluate the tolerability and safety profile of     ASP8374 in participants with locally advanced (unresectable) or metastatic solid tumors. Also     primary purpose is to characterize the pharmacokinetic profile of ASP8374 and to determine     the recommended Phase 2 dose (RP2D) of ASP8374.      The secondary purpose of this study is to evaluate the anti-tumor effect of ASP8374.   "
1662|NCT03264131|"     Adult T-cell leukemia/lymphoma (ATLL) is a rare form of cancer found mostly among people from     the Caribbean islands, Western Africa, Brazil, Iran, and Japan. Most cases of this disease in     the United States occur along the East Coast due to emigration from the Caribbean islands.     There is currently no standard treatment for ATLL. Research shows that patients who go into     first time remission (respond completely or partially to treatment) and have a bone marrow     transplant have the best outcomes. Traditional chemotherapy treatments have generally not     worked well in patients with ATLL. Additionally, not all patients will be eligible for a bone     marrow transplant.      The purpose of this study is to see how well individuals with ATLL respond to an     investigational cancer treatment. This investigational treatment combines a drug called     brentuximab vedotin with a standard chemotherapy treatment made up of cyclophosphamide,     doxorubicin, etoposide, and prednisone. This treatment is considered investigational because     it is not approved by the United States Food and Drug Administration (FDA).      Brentuximab vedotin, also known as Adcetris, is approved by the United States Food and Drug     Administration (FDA) for treatment of certain types of lymphoma in some patient populations.     Brentuximab vedotin has not been approved by the FDA for treatment of ATLL.      Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it.     Antibodies are proteins that are part of the immune system. They can stick to and attack     specific targets on cancer cells. The antibody part of brentuximab vedotin sticks to a target     called CD30 that is located on the outside of the cancer cells. Normal cells have little or     no CD30 on their surface. ATLL cancer cells often have a larger amount of CD30 on their     surface than normal cells. However, CD30 is found in different amounts on ATLL cancer cells.     This study will also test the amount of CD30 found on each participant's cancer cells.     Researchers will be looking to see if the response to the study treatment varies based on the     amount of CD30 found on the outside participants' cancer cells.      Brentuximab vedotin has previously been combined in another study with a different standard     of care chemotherapy regimen: cyclophosphamide, doxorubicin, and prednisone. The study     included patients with various types of T-cell lymphomas. Two of the patients enrolled in     that study had ATLL. Both had a complete response (no evidence of disease). The researchers     in the current study (LCCC 1637) have added etoposide to the combination of brentuximab     vedotin with cyclophosphamide, doxorubicin, and prednisone. They predict that the addition of     etoposide will improve patient outcomes. Research shows that etoposide helps improve outcomes     in patients with certain types of T-cell lymphomas who undergo chemotherapy treatment. This     investigational combination of brentuximab vedotin with cyclophosphamide, doxorubicin,     etoposide, and prednisone is called BV-CHEP.   "
1663|NCT03264118|"     The aim of this study is to evaluate the additional effect of antimicrobial photodynamic     therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone     and porcine collagen membrane.   "
1664|NCT03264105|"     Pits and fissures have been considered as the single most important feature leading to the     development of occlusal caries; About 90 % of carious lesions are found in the pits and     fissures of permanent posterior teeth .Several materials and techniques have been developed     to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite     resins as pit-and-fissure sealants   "
1665|NCT03264092|"     The study's aim is to prospectively compare three different tissue acquisition techniques     during EUS guided pancreatic solid lesions biopsies.   "
1666|NCT03264079|"     This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the     pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.      This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy     volunteers.      Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify     for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects     shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2,     following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be     administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone     methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration).      Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be     administered under fed conditions on Study Days 15-17, and Study Days 19-27.      On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be     confined beginning on Study Day -1 through the last blood sample collection on Study Day 9     during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during     Period 2.   "
1667|NCT03264066|"     This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus     atezolizumab in participants with advanced solid tumors including the following cohorts:     squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, and renal cell     carcinoma (RCC).   "
1668|NCT03264053|"     Buccal bone is prone to resorb after tooth extraction specially with immediate tooth     implantation which could compromise the esthetics of the patient. socket shield technique     retains the buccal aspect of the extracted root fragment which may help in preventing the     buccal bone from resorbing and prevent esthetics deterioration   "
1669|NCT03264040|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Mannosidosis     alpha from plasma   "
1670|NCT03264027|"     The objective of this randomized clinical trial is to compare pain levels during and after     insufflation with carbon dioxide or in subjects that will undergo endoscopic fulguration with     argon to reduce the diameter of the gastrojejunal anastomosis. The investigators hypothesize     that carbon dioxide will be superior in causing less pain and leading to less discomfort.   "
1671|NCT03264014|"     This is an investigator-initiated, multinational, retrospective, non-interventional pilot     study conducted in five haemophilia treatment centres from different geographical regions     that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia     registry. Data from a randomly selected sample of patients from national or local registries     are anonymously collated and analysed.The aims are to determine the feasibility of combining     data from national and local registries in countries with developing healthcare systems and     to assess how existing registries implemented current recommendations for data collection in     terms of available fields and their completion.   "
1735|NCT03263182|"     This study would like to determine if the introduction of the Safe Childbirth Checklist and     associated mentorship can improve the adherence of skilled birth attendants (SBAs) to the     essential practices of childbirth delivery.   "
2834|NCT03248817|"     the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75     mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension     occurred) and single shot (1.5 mcg/Kg) phenylephrine   "
1672|NCT03264001|"     Type 2 diabetes results from a combination of peripheral insulin resistance and beta-cell     dysfunction, and manifests as fasting and postprandial hyperglycemia. In Singapore, despite     the relatively low prevalence of overweight and obesity, the prevalence of type 2 diabetes is     disproportionately high and is expected to double in the near future. This indicates that     insulin resistance and beta-cell dysfunction are widely prevalent even among individuals who     are not overweight or obese. Still, weight loss induced by a variety of ways (calorie     restriction, exercise, surgery, etc.) is considered the cornerstone of diabetes treatment.     This underscores the importance of negative energy balance in improving metabolic function.     In fact, negative energy balance induced by calorie restriction can improve metabolic     function acutely, i.e. within 1-2 days and before any weight loss occurs. Likewise, negative     energy balance induced by a single session of aerobic exercise improves metabolic function     over the next few days. However, the magnitude of negative energy balance that needs to be     achieved in order to improve metabolic function, as well as possible dose-response     relationships, are not known. Furthermore, the comparative efficacy of calorie restriction     vs. exercise in improving metabolic function has never been directly assessed.      Accordingly, a better understanding of the effects of acute negative energy balance induced     by calorie restriction or aerobic exercise on insulin sensitivity and beta-cell function will     have important implications for public health, by facilitating the design of effective     lifestyle (diet and physical activity) interventions to prevent or treat type 2 diabetes.      To test these hypotheses, whole-body insulin sensitivity, the acute insulin response to     glucose, and the disposition index (i.e. beta-cell function), will be determined the morning     after a single day of progressively increasing negative energy balance (equivalent to 20% or     40% of total daily energy needs for weight maintenance) induced by calorie restriction or     aerobic exercise.      Results from this project are expected to result in the better understanding of the effects     of negative energy balance induced by diet and exercise on metabolic function. Therefore,     this project may help in the design of effective lifestyle intervention programs for the     prevention and treatment of type 2 diabetes.   "
1732|NCT03263221|"     Statistical analysis for adult patients who were admitted to Assiut university hospital     within one year with proximal femoral fractures.      Protocol of management include lines of treatment , hospital stay and results   "
1674|NCT03263975|"     The mechanism(s) by which dehydration (both intra- and extracellular) impairs performance are     still poorly described. A loss of volume results in increased occurrence of orthostatic     intolerance, including dizziness, fatigue, headaches and related symptoms with upright     posture. Any of these symptoms can contribute to decreased performance in maneuvers performed     in the upright posture, which includes many military tasks. Thus, loss of volume challenges     the cardiovascular and blood pressure responses to systemic whole body endurance exercise,     while osmolality is the stimulus for intracellular dehydration that may impair local muscle     force production by impairing contractile function, neural signaling, or both. In this study,     we will compare how both types of dehydration affect MSNA and CAC.      The results of this study will provide mechanistic insight for how dehydration (intra- or     extracellular) impairs systemic whole body and local small muscle performance in vivo. This     Basic Science study seeks to understand how volume and osmolality impact MSNA and CAC as a     basis for improving potential countermeasures, such as a more optimally formulated     rehydration beverage. Therefore, this study directly complements Task Area T10 (Hot Weather     Operations and Hydration: Injury and Performance Optimization) and impacts virtually all 14     Military Operational Medicine Research Program Drivers.   "
1675|NCT03263962|"     To evaluate canrenone effects compared to other therapies on cardiovascular mortality in     patients with congestive heart failure and preserved systolic function after 12 years of     evaluation.   "
1676|NCT03263949|"     Predict-VT is an investigator-initiated, prospective, observational clinical trial. Six     hundred patients with ST elevation acute myocardial infarction (STEMI) undergoing primary     percutaneous coronary intervention (PPCI) will be included. The primary end point is a     composite of ventricular tachyarrhythmia (VTA) and sudden cardiac death (SCD). VTAs will be     recorded using continuous electrocardiographic (ECG) monitoring in the coronary unit for the     first 72 hours, standard ECG and ECG holter monitoring. For the analysis of myocardial     function, conventional 2D echocardiography and tissue doppler will be used. For the     evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical     dispersion will be obtained. Important clinical, laboratory and angiographic variables will     also be examined. Patients will be followed-up at 6 months, 1, 2 and 4 years. The optimal VTA     prediction model will be constructed using logistic regression and bootstrap models. Patients     who experience primary end point should undergo secondary SCD prevention using implantable     cardioverter defibrillator (ICD). Patients with left ventricular ejection fraction (LVEF) <     35%, 40 days post acute myocardial infarction (AMI), will be candidates for primary SCD     prevention.   "
1677|NCT03263936|"     This is a pilot study using decitabine and vorinostat before and during chemotherapy with     fludarabine, cytarabine and G-CSF (FLAG).   "
1678|NCT03263923|"     CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or     younger, to take part in a study to compare methods of dealing with the stress of caregiving     to grandchildren. Participants need to have daily access to a computer, complete four surveys     online, and be willing to write in a journal every day for a month. Participants will be     compensated for their time.   "
1679|NCT03263910|"     Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single     dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for     endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on     the proportion of patients having no gastric peristalsis.      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions     observed between informed consent and 7 days after administration in comparison with the     placebo group.   "
1680|NCT03263897|"     Evaluate the feasibility of using a mobile interface to control the insufflator device     administering treatment for aborting (stopping) an acute episode of migraine. The patient,     under clinical supervision, will use the mobile interface to self administer the treatment     when experiencing an acute episode of migraine. The supervising clinician will monitor the     patient and the device to make sure that no harm could come to the patient and will be ready     to intervene if any adverse effects were suspected to or in the process of happening.   "
1681|NCT03263884|"     The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive     trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the     development of pain in a prolonged muscle pain model.   "
1682|NCT03263871|"     The purpose of this study is to assess the effectiveness of PTM202 in treating environmental     enteric dysfunction.   "
1683|NCT03263858|"     Assessment of the safety and clinical performance of a coronary stent system in de novo     coronary artery lesions   "
1684|NCT03263845|"     Observational study.   "
2036|NCT03259256|"     The purpose of this study is to determine if islet cell transplantation , is an effective     treatment for type 1 diabetes. Study participants may receive up to three islet transplants     and will be followed for five years to monitor blood sugar control, islet transplant     function, and changes in quality of life.   "
1686|NCT03263819|"     Patients with POTS experience significant gastrointestinal symptoms. Current evidence     suggesting that abnormal post-ganglionic sympathetic function could play a role in the     pathophysiology of these GI abnormalities. Sympathetic fiber regulate motor and the     postprandial GI peptides secretion.      The focus of the present proposal is to determine glucose homeostasis, GI motility, and their     association with GI and cardiovascular symptoms in POTS patients versus healthy controls.     Furthermore, we will determine differences in these outcomes in POTS patients with and     without evidence of postganglionic sympathetic fiber neuropathy.      As a long-term goal, this study can lead us to understand the pathophysiology of common     co-morbidities in patients with POTS to provide new treatment approaches and prevention     strategies.   "
1733|NCT03263208|"     The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and     refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The     CAR enables the T cell to recognize and kill the leukemic cell through the recognition of     CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+     leukemia.   "
1688|NCT03263793|"     The overall goal of this T2 translational research project is to pilot an interdisciplinary     high-intensity group singing program to improve speech and swallowing in patients with     Parkinson's Disease (PD) and to explore the impact of this program on quality of life (QOL).     This research has three specific aims: 1) Determine the effects of a high-intensity group     vocal training program on vocal function and laryngeal structure; 2) Determine the     transference of vocal training to laryngeal aspects of swallowing; 3) Determine the effect of     patient-reported changes in Quality of Life (QOL) as the result of participation in a group     vocal training program.      Twenty patients with Parkinson Disease will be recruited from the Fresco Institute for     Parkinson's & Movement Disorders to participate in a 12-week vocal training program. The     program will train participants using maximum vocal function exercises targeting vocal     deficits specific to PD. Choral singing therapy sessions will be conducted once weekly with     daily home practice exercises based on principles that have been successful in other     intensive PD vocal exercise programs.   "
1690|NCT03263767|"     Acute or chronic graft versus host disease is still the major complication of stem cells     transplantation regarding morbidity and mortality.      Recently, high dose cyclophosphamide utilization early after post-transplantation (day+ 3 and     +4) not only for patients with HLA- haploidentical donor but also for patients with     HLA-compatible donor, showed a great control of graft versus host disease after     transplantation, allowing to consider stopping immunosuppressive treatment after the     transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetyl). Indeed, this step has     already been completed in myeloablative transplantationin adult patients.      This approach could enable to avoid in the end several complications related to long term     immunosuppressive drugs administration, while promoting quicker immunity recovery.   "
1691|NCT03263754|"     This study aims to assess the efficacy of Pocket Medic to promote self-management and     pulmonary rehabilitation adherence in COPD patients.   "
1692|NCT03263741|"     Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in     the Patients with Locally Advanced or Advanced Gastric Cancer   "
1693|NCT03263728|"     The aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic     high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR     examinations are false positive.   "
1694|NCT03263715|"     The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared     with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind,     controlled fashion, focussing on glucocorticoid-free remission of disease.   "
1695|NCT03263702|"     This prospective, multicenter, observational study will examine the ability of real time     electrogram processing mapping to identify driver domains to target for ablation in     persistent AF patients.   "
1696|NCT03263689|"     Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and     relatively little data have been published about post-operative maternal pain control in     these settings. Cesarean section is the most common type of major operation at our     institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward     staffing capacity is low, with much basic nursing care provided by families and friends of     patients. The investigators conducted a study to examine the impact of ITM versus TAP block     in a setting of limited formal nursing oversight.   "
1697|NCT03263676|"     This is a randomized cross over trial to compare quality of life and product performance     between Icon reusable underwear versus standard disposable pad in patients with mild to     moderate urinary incontinence.   "
1698|NCT03263663|"     In this exploratory phase II trial, the possibility of a personalized treatment after     resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be     obtained, transferred into avatars and treated the same way as in the patient until     resistance arises. These resistant tumor cells are subsequently treated by different targeted     treatment combinations in the mouse avatar model to find the most active drug or combination     of drugs. This drug or combination of drugs may then be offered to the patient after     cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients     during first‐line treatment with cetuximab as well as during second line experimental     treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore     at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism     of resistance seen in the avatar model matches with the mechanism of resistance in the     individual patient.   "
1699|NCT03263650|"     The goal of this clinical research study is to learn if olaparib, when given after treatment     with cabazitaxel, carboplatin, and prednisone, can help to control aggressive variant     prostate cancer (AVPC). The safety of these drugs will also be studied.   "
1700|NCT03263637|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK),     pharmacodynamics (PD) and preliminary antitumor activity of AZD4573 in subjects with relapsed     or refractory haematological malignancies   "
1701|NCT03263624|"     Nail psoriasis has a high incidence amongst patients with psoriasis.It is estimated to affect     80% of psoriatic patients at some time during their lives and has a significant adverse     influence on their quality of life.      Treatment of nail psoriasis is disappointing, as it is refractory to treatment, with     conventional therapies often having little effect.   "
1703|NCT03263598|"     The low sodium intake is important for ascites control in liver cirrhosis patients.     Therefore, World Health Organization (WHO) recommends reduction of sodium (Na) to 2g/day for     adults. The 24-hour urine Na excretion has been regarded as a standard method to estimate the     amount of daily dietary sodium intake. However, it is too inconvenient to apply to patients     or the general population in practice. For this reason, it has been suggested that a spot     urine Na/potassium (K) ratio could be replaced with the 24-hour urine Na excretion. However,     the evidence is not sufficient for that. The investigators will evaluate the usefulness of     spot urine Na/K ratio to estimate the dietary sodium intake. The investigators will also     verify several formulas of estimating the 24-hour Na excretion with spot urine Na, K,     Creatinine (Cr).   "
1705|NCT03263572|"     The goal of this clinical research study is to learn if the combination of blinatumomab and     ponatinib can help to control Philadelphia chromosome-positive acute lymphoblastic leukemia     (Ph+ ALL); BCR-ABL-positive ALL; or ALL that has come back (relapsed) or has not responded to     treatment (refractory). Ph+ and BCR-ABL positive are types of genetic mutations (changes).     The safety of this drug combination will also be studied.      This is an investigational study. Blinatumomab is FDA approved and commercially available for     the treatment of other types of ALL. Ponatinib is FDA approved and commercially available for     the treatment of several types of leukemia, including some types of Ph+ ALL. It is     investigational to use the study drugs in combination with each other.      The study doctor can describe how the study drugs are designed to work.      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.   "
1706|NCT03263559|"     This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and     toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell     disease (SCD). Based on their age and entry criteria patients are stratified into two groups:     (1) children with SCD with strokes; and (2) adults with severe SCD.   "
1707|NCT03263546|"     The purpose of this study is to investigate if therapist-guided internet-delivered cognitive     behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective     treatment in reducing OCD symptoms for children and adolescents compared to gold standard     treatment (face-to-face CBT).   "
1708|NCT03263533|"     The main goal of this pilot study is to test the extent to which adjunctive treatment with     the histone deacetylase (HDAC) inhibitor vorinostat improves brain plasticity and cognition     in a pilot placebo-controlled trial in patients with schizophrenia who are on clozapine.   "
1709|NCT03263520|"     Compare the use of nandrolone associated with corticosteroid for the treatment of     cancer-induced malnutrition to treatment with corticosteroids alone in patients with tumors     in the high gastro-intestinal tract, liver, pancreas and bile ducts in palliative treatment.   "
1710|NCT03263507|"     The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of     IONIS-PKK-LRx administered subcutaneously to Healthy Volunteers   "
1711|NCT03263494|"     Adolescents and young adults with T1D and poor glycemic control (age 14-< 25 years, T1D     duration >12 months, hemoglobin A1c (HbA1c) 7.5-<11.0%, using an insulin pump or MDI)) will     be randomly assigned to either continuous glucose monitoring (CGM) or blood glucose     monitoring (BGM). Sample size will be 150. The primary outcome assessment will be HbA1c after     6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded     CGM at 13 and 24 weeks), and quality of life measures. The randomized trial will be followed     by a 6-month extension study during which the randomized controlled trial (RCT) control group     will initiate CGM and the RCT CGM group will continue CGM.   "
1712|NCT03263481|"     The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as     determined by a 30 minute intraductal secretin stimulation test in patients with a low     likelihood of pancreatic pathology and to compare these data to those obtained from our     historical patients with suspected chronic pancreatitis. These will be patients in which     inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde     cholangiopancreatography (ERCP) for biliary indications . All study subjects will receive a 5     day follow-up phone call. Enrollment goal is 36 subjects.   "
1713|NCT03263468|"     This study is being conducted in patients with a major heart attack caused by a blocked     artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50%     of people with an heart attack are found to have one or more additional narrowings that did     not cause the heart attack. At present the best way to manage these additional blockages is     not known. Many cardiologist recommend opening these blockages at at a later time after the     heart attack. The present study is examining if PCI of all blockages at the same time as the     PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of     heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI).     Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and     monitor adverse events.   "
1736|NCT03263169|"     A pragmatic randomized trial to evaluate the impact of an integrated patient experience and     outcome measurement system supported by citizens, caregivers and community through eHealth     technology.      The primary research question is: What is the effectiveness of the WECCC approach on quality     of life in people aged 65 and older or who self-identify as disabled compared to people not     receiving the Health TAPESTRY program?   "
1722|NCT03263351|"     There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in     girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk     for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for     worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies,     the investigators found that a brief cognitive-behavioral therapy group decreased depressive     symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D     with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a     cognitive-behavioral therapy depression group vs. a health education control group for     improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse     adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up;     2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test     changes in cortisol factors as explanatory.   "
2037|NCT03259243|"     To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing     laparoscopic gynecologic surgery   "
1714|NCT03263455|"     Stroke is the second leading cause of death worldwide and the third most common cause of     disability. The effects of stroke are variable and may include impairments in motor and     sensory systems, emotion and neuropsychological deficits such as a disorder of spatial     awareness known as unilateral spatial neglect (USN). Approaches to ameliorate USN could be     categorized in interventions as involving either bottom-up or top-down processing. The     specific mechanisms underlying these effects on a number of manifestations of the USN     syndrome may include the restoration of defective representations of the side of space     contralateral to the lesion (contralesional), and of the ability to orient spatial attention     contralesionally, through complex patterns of activation of both the damaged right     hemisphere, and the contralateral left hemisphere, with differences related to the specific     stimulation delivered to the patient. In recent years, increasing cutaneous stimuli through     neuromuscular kinesiotaping has been proposed to enhance somatosensory inputs (24) and such     as method could have positive effects on USN. The aim of the present study was to assess the     effect of KTM applied on the sternocleidomastoid muscle controlateral side of the lesions in     improving USN deficits in individuals with stroke patient in sub-acute phase. The hypothesis     is that the KTM application could improved cognitive tests for assessing USN, motor deficits     and kinesthetic neck sensibility.   "
1715|NCT03263442|"     Purpose: To conduct a randomized controlled pilot study investigating the use of high dose     intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium,     including health-related quality of life (HRQOL), functional status, and neuropsychiatric     outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic     hematopoietic stem cell transplant (HSCT).      Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for     allogeneic stem cell transplant.      Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after     transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will     be measured weekly and participants will be assessed for evidence of delirium using validated     measures. Validated measures will also be used to assess cognitive function, depression,     post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at     one, three, and six months after transplant.   "
1716|NCT03263429|"     This phase I/II trial studies the best dose and side effects of glutaminase inhibitor CB-839     and how well it works with panitumumab and irinotecan hydrochloride in treating patients with     RAS wildtype colorectal cancer that has spread to other places in the body and does not     respond to treatment. Glutaminase inhibitor CB-839 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in     chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Giving glutaminase inhibitor CB-839 with panitumumab and irinotecan     hydrochloride may work better in treating patients with colorectal cancer.   "
1717|NCT03263416|"     This is a prospective, comparative, open label, randomized, multicentric study evaluating the     benefit of a dedicated and coordinated follow-up on treatment adherence in patients with     metastatic solid tumor and starting a first cycle of treatment compared to standard     follow-up. A dedicated and coordinated follow-up during the treament period will be based on     a telephone follow-up and a pharmaceutical conciliation.      Patients will be randomized into one of two study arms:      Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a     pharmaceutical conciliation made by the Center Pharmacist.      Arm B: Standard follow-up during the treatment period.      Patients will be followed during 6 months.   "
1718|NCT03263403|"     This study will be a randomized observer -blinded controlled non-inferiority study to     evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Menomune®-     A/C/Y/W-135 on a total of 88 healthy adult participants (18-45 years of age). 44 participants     will receive locally produced Ingovax ACWY and 44 participants of comparator groups will     receive Menomune® - A/C/Y/W which is produced by Sanofi Pasteur Inc. Vaccination will be done     in Day 0 following the screening and pre-immunization blood sample collection and     post-immunization blood will be collected at Study Day 30. Follow- up by home visit will be     carried out from Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The     hypothesis of this study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY     is non inferior and immunogenic among adults in Bangladesh as compared to Menomune® -     A/C/Y/W-135.   "
1719|NCT03263390|"     This study aims to characterize the neurological basis of obesity and response to surgical     and medical treatment by inducing adult pluripotent stem cells into neuronal cells from     subjects that have demonstrated extreme response to bariatric surgery or pharmacological     treatment for obesity.   "
1720|NCT03263377|"     In order to improve child nutrition, the Poverty Reduction Strategy adopted by the Government     of Bangladesh (GoB) has called for the initiation of a school feeding programme for primary     school children living in poor and disadvantaged families and communities where the     prevalence of child malnutrition is high. Accordingly, a pilot feeding programme is planned     for implementation in Government and NGO schools in 10 Upazilas in rural Bangladesh with the     aim of: 1) enhancing the nutritional status and growth of younger school-going children by     reducing micronutrient deficiencies and providing a protein/calorie supplement; 2) improving     learning capacity and attentiveness in the classroom; 3) increasing enrollment, attendance     and completion rates and 4) supporting the goals of achieving universal primary education and     reducing gender disparity.      The objectives of the proposed baseline survey respond to GoB's aims:        1. To assess the nutrition status of younger school-going children prior to the initiation          of a school feeding programme, thus enabling the later assessment of programme impact on          micronutrient deficiencies and anthropometric indicators.        2. To assess the cognitive performance and school attendance of children prior to the          initiation of a school feeding programme thus enabling the later assessment of programme          impact on school enrollment and attendance, and learning capacity.      The baseline study will be conducted using a cluster randomized study design in which schools     represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10     that have been selected for intervention. A control group will be included in study design     consisting of 7 schools selected randomly from 7 comparable yet adjacent Upazilas not slated     for inclusion in the feeding programme. Use of a control group will enable later evaluations     to attribute possible improvements in key impact/outcome variables to the intervention     itself. A mid term evaluation will be conducted 6 months after the baseline survey. Finally,     an impact evaluation will be conducted on the same children 10-14 months after the baseline     survey.   "
1721|NCT03263364|"     Unexplained polycythemias are rare diseases, and therefore, the collection of data inherent     to these diseases will not only improve their characterisation, but also allow stratification     according to the risks and the course of the disease. The objective of this project is to     constitute a database on the disease which will allow us to better understand it and in due     course improve its management.      The GENRED project thus bears uniquely on the collection of information, which will be     gathered throughout the usual management of patients for this type of disease.   "
1725|NCT03263312|"     This is a single center prospective longitudinal exercise training study and will enroll     approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical     activity level between the ages of 10-40 years.      Participants will undergo an MRI of the Fontan circulation. This will include imaging of the     heart, lung and liver. This will include specific imaging for tissue characterization and     assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow.     The investigators will then draw blood (approximately 10 ml) for assessment of serum     biomarkers and circulating microRNAs of interest. The participants will undergo exercise     testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6     month study period the participants will return back for a follow up and repeat all the     testing completed at enrollement.   "
1726|NCT03263299|"     Ovarian stimulation will be done using the Microdose flare-up regimen. The patient will     receive diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously     twice daily. Two days later, stimulation will be initiated by intramuscular (IM) injections     of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.      Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography     and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany)     will be injected when at least 2 follicles 18 mm were observed on ultrasonography.      Oocytes willbe retrieved 36 hours after hCG injection using a 17-gauge aspiration needle     under transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure     that there is no internal bleeding.      After fertilization was confirmed when two polar bodies and two pronuclear were observed     18-20 hours after insemination, one to three grade A embryos were transferred at day 3     fertilization.      The luteal phase support will be initiated from the day of oocyte retrieval for all patients     with (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the     day of serum pregnancy test was done.   "
1727|NCT03263286|"     This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke     victims regain functional use of their hand and regain independent living. Participants will     use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes     from the intervention after the 8 weeks and also at a 3 month followup.   "
1728|NCT03263273|"     To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed     by the change in inflammatory lesion count from baseline over the 12-week treatment period in     patients with moderate-to-severe papulopustular rosacea.   "
1729|NCT03263260|"     Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and     efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of real-world     patients.   "
1730|NCT03263247|"     The current project aims to investigate the efficacy of the visual imaging training (VIT) and     alphabet search training in comparison to an active control intervention, namely     psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive     impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to     biomarkers (PET PIB, PET FDG and liquor).   "
1731|NCT03263234|"     Europe is undergoing a demographic change with a rapidly growing population of 65 years+.     This challenges municipalities and hospitals as the ageing citizens need care and treatment     due to an age-related decline in physical and mental capacity. Therefore municipalities are     experiencing a growing need for sufficient and customized housing, which can support the     elderly citizens in sustaining well-being and health along with preventing functional     decline. Well-fare technologies, such as Circadian adjusted LED-based lighting (CALED), are     suggested as a remedy for this.      To obtain proper visual sharpness and better contrast, people of older age require heightened     light levels due to age-related failing vision. Furthermore, inappropriate light at night     disrupts not only sleep but also the timing of the circadian rhythm, with negative     consequences on cognition and emotions. Therefore CALED is being increasingly considered for     use in hospitals and elderly housing because of its wide spectrum of wavelengths, good     contrast and fast switching, and possibility to support a normalised circadian rhythm.      Lighting based on LED has been shown to improve the quality of sleep and to improve     well-being in the elderly. However, it is not known whether CALED mimicking a normal     circadian rhythm has the same benefits for elderly persons with frailty or dementia. The     investigators therefore want to test the effects of CALED in elderly people with frailty and     mobility disabilities and/or dementia living in elderly housing. The investigators     hypothesise that CALED can improve sleep and well-being in both elderly with frailty and     dementia.   "
1738|NCT03263143|"     The study compares early palliative care consultation to standard of care in the medical     intensive care unit (ICU). The study will assess if the intervention leads to an increased     proportion of clearly delineated goals of care and quality of life and examine if this     intervention leads to decreased length of days in the ICU, Hospital, and on mechanical     ventilation.   "
1739|NCT03263130|"     The purpose of this cross-sectional, observational study is to evaluate the site and     mechanism(s) for expiratory airflow limitation in chronic, treated, current or former smokers     (>15 pack years) with COPD, Emphysema, and Asthma-COPD Overlap with mild to severe expiratory     airflow limitation. Treatment may include short and long acting inhaled beta2agonists, short     and long acting inhaled muscarinic receptor antagonists, inhaled and or oral corticosteroid,     oral antibiotic, supplemental oxygen, and PDE type 4 inhibitor. In some cases, the patient     may have had a history of asthma preceding the development of COPD (Asthma COPD Overlap).   "
1740|NCT03263117|"     Objectives:      This study aims to assess if the use of general anesthesia (GA) or sedation (CS) in patients     with acute stroke undergoing intra-arterial mechanical thrombectomy, leads to better     neurological outcomes and less peri-procedural complications.      Hypothesis Null Hypothesis: There are no differences in outcomes in patients with acute     stroke treated by intra-arterial mechanical thrombectomy using General anesthesia or     Sedation.   "
1756|NCT03262909|"     Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective     treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a     historical control arm (microfracture) in the treatment of cartilage defects in the knee.   "
1757|NCT03262896|"     This study examines muscle movements of elecromyography in adults with brain death. Half of     the participants will have brain death, the other half will be healthy volunteers.   "
36872|NCT02803060|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
1741|NCT03263104|"     Coronary heart disease (CHD) is one of the major causes of death and disability in     industrialised countries. Results from several epidemiological and clinical studies indicate     a positive correlation between elevated total serum cholesterol levels, mainly reflecting the     LDL-cholesterol fraction, and risk of CHD. It is thought that a reduction in total plasma     cholesterol levels in populations suffering from primary hypercholesterolemia (elevated     cholesterol) can lower the incidence of coronary thrombosis. Currently, therefore there is     extensive interest in the management of serum cholesterol and other blood lipids. Diet is     viewed as a major influencing factor that can reduce levels. This is largely driven by the     expense of drug therapy, the large numbers of individuals affected and unwanted side effects     of such treatments. Dietary strategies for prevention of CHD implicate adherence to a     low-fat/low-saturated fat diet. Although such diets may present an effective approach, they     are difficult to maintain on a long-term basis and efficacy diminishes over time. As such,     new approaches towards identification of other dietary means of reducing blood cholesterol     levels have been evaluated. These include, among others, the use of probiotics. Probiotics     are 'live microbial feed supplements that offer a benefit to health'. They are marketed as     health or functional foods whereby they are ingested for their purported positive advantages     in the digestive tract and/or systemic areas like the liver, vagina or bloodstream. The main     goal of the study was to test whether probiotics can directly degrade cholesterol as well as     produce metabolites that interfere with its synthesis in the liver. The effect may also be     partially ascribed to an enzymatic deconjugation of bile acids.   "
1742|NCT03263091|"     The purpose of this study is to determine whether FG-4592 is safe and effective in the     treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood     Cell Transfusion Burden.   "
1743|NCT03263078|"     The purpose of this study is to compare the difference between total intravenous anesthesia     to inhaled anesthesia in major surgery.   "
1744|NCT03263065|"     This study will compare 3 food products (bran, psyllium and nopal) on intestinal water     content measured via MRI.   "
1745|NCT03263052|"     This study will investigate whether converting patients from FDA approved immediate-release     tacrolimus to FDA approved extended release tacrolimus (Envarsus) reduces neurological     side-effects, improves quality of life, and enhances adherence. A select group of elderly (>     60 years of age) patients, who are especially sensitive to tacrolimus-related adverse (AEs)     effects, will be provided the opportunity to convert to Envarsus with this study.   "
1746|NCT03263039|"     In the RESPONDER study, the role of the immune evasive mechanisms combined with genomic     characterization will be explored in urothelial cancer patients treated with second-line     treatment with pembrolizumab.      Combined profiling of immune and molecular status is novel and may contribute to improved     patient stratification and provide rationale for future treatment strategies containing     pembrolizumab.   "
1758|NCT03262883|"     It is known that the number of Chronic Critical İllnes, an iatrogenic condition, increases     all over the world. The prevalence of Chronic Critical Illness in Turkey is unknown. The     investigators aimed to evaluate the etiology, comorbid conditions, demographic data,     prevalence, mortality and costs of these patient in intensive care units in Turkey. In this     multi-centered study, The investigators will retrospectively review the last 1 year of     patients receiving treatment at the Adult Intensive Care Unit.   "
1759|NCT03262870|"     Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating     disease of the central nervous system.   "
1956|NCT03260309|"     Success of the hip arthroplasty depends on the measures that optimize perioperative     conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.   "
1750|NCT03262987|"     May-Thurner syndrome is the result of compression of the left common iliac vein between the     right common iliac artery and overlying vertebrae.      In This Study , We will detect the role of color doppler US in the diagnosis of May-Thurner     Syndrome in comparison to Direct CT Venography   "
1751|NCT03262974|"     Imatinib, the tyrosine kinase inhibitor, is used for treatment of Philadelphia positive     chronic myeloid leukemia. Despite its efficacy and favorable pharmacokinetic profile, there     is a large inter-individual variability in imatinib plasma concentrations, which may lead to     treatment failure and disease progression. Polymorphisms in genes related to absorption,     distribution, metabolism and excretion of imatinib may affect the bioavailability and     consequently the response to the drug.      The study aims to investigate the possible effect of genetic polymorphisms in certain     metabolizing enzymes [CYP3A5*3 (rs776746), CYP2C8*3 (rs11572080 and rs10509681)] and membrane     transporters [ABCB1 2677G>T/A (rs2032582) and SLC22A1 1222A > G (rs628031)] by PCR on the     plasma level (by HPLC-UV) and molecular response (MMR) of imatinib in patients with CML.      The study also aims to provide CML patients with a personalized treatment option, thereby     probably improving the response and reducing the side effects.   "
1752|NCT03262961|"     -  Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to          severe pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention.        -  Previous studies have shown that expectant and conservative management of pre-eclampsia          in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has          been estimated that for each additional day of pregnancy prolongation between 24 and 32          weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival.        -  Sildenafil citrate has been used for increasing utero-placental perfusion in cases with          intrauterine growth restriction, which makes it a promising drug in management of mild          pre-eclampsia.   "
1753|NCT03262948|"     This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage     IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent     squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to     one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status,     smoking status, disease staging.   "
1754|NCT03262935|"     The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is     superior to physician's choice in prolonging progression free survival.   "
1755|NCT03262922|"     The aim of the study is to compare the exposure to environmental and professional toxics by     patients with systemic scleroderma and by patients not achieved by this pathology.   "
36873|NCT02803047|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
2001|NCT03259711|"     Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast     cancer seems to have an impact on the cardio-vascular system. This study investigates reports     of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC)     classification: L02 in the European pharmacovigilance database, Eudravigilance.   "
23018|NCT02984319|"     Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young     men   "
1760|NCT03262857|"     60 healthy patients pulpitis and requiring root canal therapy are selected. . Sampling was     done in a simple and non-experimental way from a dental clinic in Isfahan, and then the     samples were randomly assigned to one of the two experimental groups (A, B) using simple     random numbers.      Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware     of the nature of the design and is not involved in the design, and each letter A or B is     written. This statement is not decoded after the statistical examination. Therefore, the     study is blind and blind. In this way, 60 patients are examined in 2 groups of 30 First,     patients with recognized pulpitis in mandibular posterior teeth have been identified and     information about them is given. Patients will be introduced to the executive phase after the     required explanation and clarification of the ambiguity and written consent. After completing     the patient information form by the practitioner and complying with all entry and exit     criteria, the study begins on each patient.      The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale     (VAS). This pain measurement method involves a 180 mm line with descriptive words that     differentiates patients on a line where the best describes their pain. In order to design a     standard injection of the maxillary nerve block in all patients, using Aspirating Dental     Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject,     Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed     with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above     the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the     tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of     the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the     syringe body in the perimmel area of the opposite side), and after the aspiration of the     contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of     numbness of the lips, the patient begins to study and the access cavity begins on the desired     tooth. In each of the stages of acquiring the access cavity or entering the initial file to     the canal, in the event of pain, the treatment is suspended and the patient signs his pain on     the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over.     In the absence of anesthetized lips, the patient is excluded from the study and after     completing the injection, the root canal is given.   "
1761|NCT03262844|"     Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a     series of neurological dysfunctions and deformities attributable to abnormally increased     tension on the spinal cord, which is lacking effective treatment to relieve the symptoms and     prevent progression. Dr. Shi recently proposed a new technique as nerve root axial     decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet,     the effectiveness and safety should be further studied.      Purpose: The aim of this study is to compare the effectiveness and safety of clinical     outcomes between capsule surgery and conservative treatment in patients with TCS. A study     hypothesis is that outcomes will be improved after capsule surgery.      Methods: This study is a randomized clinical trial with a two-factor (2x7) research design.     The TCS patients will be randomly assigned in one of the two treatment groups: capsule     surgery and conservative treatment. Seven outcome measures will be collected pre-operative     for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits,     including: International Consultation on Incontinence Modular Questionnaire Short Version     (ICI-Q-SF), Rintala Score, a new developed Chinese version of questionnaire, Oswestry     disability index (ODI), SF-12, foot function index (FFI) and Pirani score. Urodynamic     testing, bladder ultrasonography, electromyogram, muscle strength and sensation of lower     limbs will be obtained before and post treatment, to determine the patient`s function of     lower limbs. The investigator performing the outcome measures will be blinded to group     assignment, and therefore will not participate in treatment. After randomization, the     conservative group will be followed up in the outpatient clinic. The capsule surgery group     will receive the nerve root axial decompression surgery (capsule surgery).      Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences     in the seven measures between groups and at the five different time frames with the α level     set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the     differences in the urodynamics and muscle strength data over time and between groups.   "
1762|NCT03262831|"     The investigators hypothesize that a personalized yoga program with mindful movement     implemented during breast cancer therapy will benefit women in multiple ways. The     investigators predict that women participating in the program will experience less weight     gain and fatigue and will have an improved quality of life compared to women not     participating in the program. The investigators predict that this will be associated with     decreased markers of inflammation. The investigators will also evaluate whether there is     improved pathologic response rate compared to historical controls. This study will provide     pilot data for a larger randomized controlled trial assessing whether program can provide     long-term improvement in quality of life, weight maintenance, and the serum and tumor changes     correlating with a reduced risk of recurrence and mortality.   "
1763|NCT03262818|"     The investigators have developed co-registered photoacoustic and ultrasound (US) imaging     technique that allows the investigators to visualize tumor structure and functional changes     simultaneously, which may potentially reveal early tumor angiogenesis development that is not     available by US alone. The ability to detect early angiogenesis changes, as well as tumor     morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance     the care for women.   "
1764|NCT03262805|"     The current study is designed to assess the pain relieving effect of 4-weeks ingestion of     this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per     day) in mild to moderate OA subjects. Also, the current study intends to assess the safety     and efficacy of long term administration of Lanconone in larger sample size as compared to     the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and     function by means of self-reported WOMAC & Lequesne questionnaire.The effect of IP on     clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.   "
1765|NCT03262792|"     This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the     effect of ParActin® at low dose of 300 mg/day and high dose of 600 mg/day in the study     population in the age range of 40-70 years and suffering from mild-moderate OA.   "
1766|NCT03262779|"     The investigators propose a trial to evaluate if the addition of ipilimumab to nivolumab     after primary resistance to anti- programmed death 1 (PD-1) axis therapy can lead to     objective radiographic tumor regression.   "
1831|NCT03261934|"     Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer     (GC). The present study aims to developed risk assessment and syndrome evolution models of     CAG malignant transformation events combining TCM indicators with modern medicine indicators.     The proposed study is a registry study based participant survey conducted in 4 hospitals in     Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed     with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and     off-site by telephone to track malignant transformation events.   "
4832|NCT03222622|"     This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream     in patients with mild to moderate psoriasis.   "
3887|NCT03234998|"     The objective of this study is to investigate the effects of two different dual-task balance     interventions for stroke patients and older adults.   "
1768|NCT03262753|"     Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty     or stent implantation. Although short-term results are excellent with all three treatment     modalities, long term cardiovascular (CV) morbidity and mortality remain high, likely due to     persistently abnormal vascular function. The effects of treatment modality on long term     vascular function remain uncharacterized. The goal of this study is to assess vascular     function in this patient population for comparison among the treatment modalities. Methods:     Vascular function in large and small arteries will be prospectively assessed fusing multiple     non-invasive modalities, and the results will be compared among the three groups of CoA     patients previously treated using surgery, balloon angioplasty or stent implantation after     frequency matching for confounding variables. A comprehensive vascular function assessment     protocol was created to be used in 7 centers. The primary outcome is arterial stiffness     measured by arterial tonometry. Inclusion and exclusion criteria were carefully established     after consideration of several potential confounders. Sample size was calculated for the     primary outcome variable. Conclusions: Treatment modalities for CoA may have distinct impact     on large and small arterial vascular function. The results of this study will help identify     the treatment modality that is associated with the most optimal level of vascular function,     which, in the long term may reduce CV risk.   "
1769|NCT03262740|"     The purpose of this study is to investigate the effect of BMS-986195 in combination with an     oral contraceptive in healthy female patients.   "
1770|NCT03262727|"     The purpose of this study is to investigate the effect of BMS-986165 in combination with an     oral contraceptive in healthy female patients.   "
1771|NCT03262714|"     The goal of this randomized controlled trial is to investigate the effects of a dance     intervention on cardiovascular risk factors and functional capacity of older women, comparing     dancing to a walking exercise intervention and to an active control condition (stretching).     The participants will include women between 60 and 80 years old, with body mass index     inferior to 35 Kg /m2. The main outcome of this study is the peak oxygen consumption     (VO2peak). The secondary outcomes are cardiovascular risk associated factors (C-reactive     protein, TNF-alpha, lipid profile, etc) and functional performance (muscle strength and     power, balance, gate ability, etc). The experimental design will include 3 parts: 1)     Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test,     assessments of body composition, balance, gate ability, muscular strength and power. 2)     Period of interventions: patients will be randomized to one of the three following groups:     dance, walking or stretching. The duration of the interventions will be 8 weeks, including 3     sessions per week for dance and walking, and once a week for the stretching group. Each     session will last 60 min. 3) Post-intervention assessments: the same protocols of testing as     pre-intervention.   "
1772|NCT03262701|"     There have been many adjunctive treatments for the additional clinical benefits to scaling     and root planing (SRP) in the treatment of chronic periodontitis. Topical hydrogen peroxide     (HP) delivered in a custom fabricated tray has been shown to improve pocket depth (PD) and     inflammation. The purpose of this study is to assess the adjunctive treatment outcome of HP     gel in custom tray application in individuals with chronic periodontitis receiving SRP. The     purpose of this investigator-initiated study is to evaluate and compare the clinical effects     of scaling and root planing (SRP) combined with local delivery of 1.7% hydrogen peroxide (HP)     gel in customized trays to that of SRP alone.   "
1774|NCT03262675|"     NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed     with 100 tunisian cardiologists.   "
1775|NCT03262662|"     Varenicline is the most effective smoking cessation therapy available. Nevertheless, most     smokers using varenicline relapse within the first few months after quitting. Varenicline is     hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking     during the standard 1-week pre-quitting treatment phase. Learning theory and previous human     and animal research support the hypothesis that a longer period of varenicline treatment     prior to the target quit date (TQD) will lead to greater reductions in smoking before     quitting, and higher long-term cessation rates, compared to standard varenicline treatment.     Building on promising preliminary clinical data, the study tests these hypotheses with a     full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized     to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD     varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will     receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The     primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks     8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating     mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and     subjective measures assessed both in the lab and using real-world, real-time electronic     momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking     cessation will be improved among the extended run-in group compared to the standard run-in     group. The investigators further predict the improved clinical outcomes with extended run-in     varenicline will be explained (or mediated) by greater pre-quit reductions in smoking     reinforcement among the extended run-in group compared to the standard run-in group. The     significance of this work is clear: The project aims to make best available treatment for     smoking cessation even better, using a method that is ripe for dissemination and an approach     that will elucidate critical mechanisms to target in the next generation of treatment     enhancement.   "
1776|NCT03262649|"     The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a     population-based research registry.      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline     survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys     and annually with interviews. Diagnosis and disease type were verified by chart review.   "
1832|NCT03261921|"     One of the most commonly used regional anesthetic techniques in pediatric surgeries is the     caudal epidural block. Its main disadvantage remains the short duration of action. Hence,     different additives have been used. Dexmedetomidine as an additive to the local anesthetic     bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so     is dexamethasone. The investigators aimed to study the effect of combining both additives in     the duration of analgesia, decreasing side effects and decreasing anesthetic doses   "
2014|NCT03259542|"     This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of     the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A,     given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations     are given after a meal.   "
5010|NCT03220295|"     This is a safety study of the molecule VU319 to ascertain pharmacokinetic and pharmacodynamic     data and test cognitive enhancement in healthy volunteers.   "
1975|NCT03260062|"     The purpose of this research study is to develop and evaluate a parent training program,     which aims to improve language. The study is being conducted to see if teaching parents     positive parenting techniques and behavior strategies will improve the rate of language     development in children with cochlear implants when compared to standard speech therapy     (e.g., auditory-verbal therapy).   "
1777|NCT03262636|"     Primary malignant and non-malignant brain tumors account for an estimated 21.42 cases per     100,000 for a total count of 343,175 incident tumors based on worldwide population estimates.     These entities result in variable but disappointing rates of survival, particularly for     primary brain tumors (5-year survival rates: anaplastic astrocytoma 27%; glioblastoma     multiforme 5%). Metastatic brain tumors outnumber primary brain tumors (estimates as high as     10:1) as they affect approximately 25% of patients diagnosed with cancer. In terms of brain     tumor surgery, the extent of surgical resection—a factor that is greatly impacted by a     Neurosurgeon's ability to visualize these tumors—is directly associated with patient outcomes     and survival. Although spinal cord tumors are lower in terms of their incidence, data     correlating extent-of-resection to outcomes and survival have been demonstrated in patients     with intramedullary tumors. Using systemically delivered compounds with a high sensitivity of     detection by near-infrared fluorescence, it would be possible for us to improve surgical     resection thus minimizing chances of recurrence and improving survival. The use of an ICG     probe registered with MRSI-derived metabolic data allows for the operating field and tissue     at the tumor/normal brain or spinal cord interface to be observed in real-time.   "
1778|NCT03262623|"     Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that     causes pain and functional limitation. Although different nonsurgical conservative therapies     such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid     injections in addition to surgical approaches have been used, yet there is no standard     treatment for lateral epicondylitis.      Objectives: The primary objective of this study is to assess the effectiveness of nerve     stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary     outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.      Methods: This is a prospective randomized, double blind clinical trial that will be conducted     between September 2017 and March 2018. Patients will be randomly allocated into two groups.     Group I will receive radial nerve block guided by a nerve stimulator. Group II patients will     receive placebo through radial nerve block. Patients will be followed up for 2 weeks.   "
1779|NCT03262610|"     The objective of this single patient study is to assess the safety and efficacy of     setmelanotide as a treatment of severe metabolic abnormalities resulting from LD, especially     refractory hypertriglyceridemia leading to recurrent bouts of pancreatitis.   "
1780|NCT03262597|"     The beverage hydration index (BHI) assesses the hydration potential of any consumable fluid     relative to water. The BHI is a relatively new metric. Our purpose was to assess the BHI of     beverages never previously tested, including an amino acid-based oral rehydration solution     (AA-ORS), a glucose-containing ORS (G-ORS) and a sports drink (SD) compared to water     (control).   "
1781|NCT03262584|"     The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens,     is more accurate than other noninvasive options and can report fungal genomic load.   "
1782|NCT03262571|"     Purpose. The aim of this study is to evaluate whether lung ultrasound, in addition to     physical examination, leads to a reduction of the admission rate for acute decompensated     heart failure of patients with chronic heart failure (HF) followed in the outpatients heart     failure clinic.      Methods. This is a prospective randomized study. The planned sample size consists of 440     patients with chronic HF.      The inclusion criteria are: (1) male and female aged between 18 and 90 years (2) signed     written informed consent (3) history of HF for at least six months, (4) left ventricular     ejection fraction < 45%, (5) adequate medical therapy for HF for at least two months.      The exclusion criteria are: (1) concomitant enrollment in other clinical studies, or     treatment with experimental drugs or devices within 30 days of clinical assessment, (2)     inability to undergo to the planned follow-up and procedures (3) documented pulmonary     infections (3) interstitial lung disease and class 4 chronic obstructive pulmonary disease     according to GOLD classification.      Patients are randomized in two groups: group A, patients undergoing to lung ultrasound and     physical examination; and group B, patients undergoing to physical examination only. Patients     are evaluated at baseline and after three months with medical history, Quality of Life test,     physical examination, blood sample for hematochemical (creatinine, electrolytes,     BNP/NTpro-BNP).      The diuretic therapy is then optimized according to the presence and severity of B-lines in     group A and physical examination in group B.      Only patients enrolled in group A undergo to a lung ultrasound examination to assess the     extent of pulmonary congestion, through its evidence of B-lines. B-lines originate from the     contrast between air-filled structures and water-thickened pulmonary interlobular septa. This     leads to linear echogenic vertical artefacts that spread from the pleural layers downwards in     the screen. The ultrasound examination is performed with a handheld echocardiography device.     The physician carries out a scan of the pulmonary fields, from basal towards mid and apical     fields, through the midaxillary line while the patient lies supine. The quantification of     B-lines is performed according to their extent over the lung fields. All the information are     recorded in dedicated forms.      The results are evaluated according to the following criteria. The primary end-point is a     significant reduction of hospitalizations for acute decompensated HF in group A during the     follow-up period. The secondary end-points are changes of NT-proBNP values, quality of life     test (QLT) score and cardiac mortality.   "
1783|NCT03262558|"     Cardiac surgery with extracorporeal circulation (ECC) yields a deep immune system dysfunction     that exposes patients to postoperative infectious complications. Among these, post-operative     mediastinitis with Staphylococcus aureus (SA) generates significant morbidity and mortality.     Two radically different approaches have been proposed in recent years to reduce the incidence     of this complication. A first approach has attempted, without real success, to decrease     postoperative immunosuppression. The second, more efficient, consisted of screening and     preoperatively treating patients colonized with SA. However, although its incidence has     decreased, postoperative mediastinitis remains a terrible nosocomial infection. The authors     believe that a thorough analysis of the immunological changes induced by cardiac surgery will     initiate active therapeutics to reduce the post-operative immunosuppression phase, thereby     decreasing the risk of nosocomial infections. In addition, a study of the interactions     between the operated (host) and staphylococcus aureus (pathogenic) immune systems will     provide a better understanding of the mechanisms that expose patients to this bacterium.   "
1784|NCT03262545|"     The study is to investigate the efficacy and safety of apatinib in patients with advanced     ovarian cancer,who has received second-line chemotherapy and failed.   "
1833|NCT03261908|"     Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of     simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese     population than other racial groups. There is still lack of research data in Chinese. In this     study, we will investigate whether there are specific genotypes which may predict the     incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide     a basis for developing guidelines on precise medication in simvastatin therapy apply to     Chinese population.   "
2198|NCT03257111|"     Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be     recruited into the study. The participants will wear two activity monitors (one commercial     grade and one research grade) for the duration of their rehab stay. Data from the monitors     will be correlated with rehab outcomes, therapy units billed, and length of stay.   "
1785|NCT03262532|"     Transesophageal echocardiography (TEE) is often used by anesthesiologists during cardiac     surgery, as a monitoring tool in non-cardiac surgery, and as a point of care diagnostic tool     in the intensive care unit (ICU). Furthermore, TEE is becoming a core skill in many     specialties to facilitate focused cardiovascular assessment in hemodynamically compromised     patients in various settings. Educators must determine how to best instruct current and     future trainees to achieve clinical competence in TEE within a time limited and constantly     expanding medical curriculum.      In this study the investigators will evaluate a new online TEE Simulation module as a     learning tool to accelerate and enhance traditional clinical teaching. This project will     evaluate a new online TEE Simulation module that replicates the actions required to adjust     TEE probe position and the ultrasound plane in relation to a 3D heart model.      The investigators hypothesize that experience with the online TEE simulation module will     improve the ability of trainees to independently perform TEE probe manipulations necessary to     obtain standard TEE views. The proposed study will answer this question by measuring the     performance of trainees in obtaining 10 of the 25 standard TEE views using the Vimedix     mannequin-based ultrasonography simulator following an hour of review of the online TEE     Simulation module.      The educational benefit of the Web-based TEE simulation module, will be evaluated by 20     novices randomly assigned to two groups, a control group of 10 subjects without exposure to     the Web-based simulation, and an experimental group of 10 subjects with exposure to the     Web-based simulation. Both groups will be assessed on their performance in attaining the 10     standard TEE views with the Vimedix simulator.   "
1786|NCT03262519|"     Obstructive sleep apnea (OSA) is an extremely common disease with inadequately explored     neurocognitive consequences. The investigators will study OSA patients before and after     treatment to understand how OSA changes decision making abilities, and whether treatment can     reverse such cognitive changes. These results could provide deeper insight into how OSA     affects decision making either temporarily or permanently, and provide another rationale or     motivation for treatment of OSA in adults.   "
1787|NCT03262506|"     There is evidence that computerized cognitive training can improve cognition in healthy older     adults and in people at risk of developing dementia, although an effective model to implement     the training in the daily life of people and to ensure engagement is missing. This project     studies the adherence, engagement and progress on computerized cognitive training exercises     that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its     associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte     and Brasilia) received licenses to perform the exercises on line and were followed by a team     of psychologists. We will evaluate adherence, engagement and progress on the computerized     cognitive training exercises of those subjects.   "
1788|NCT03262493|"     Enteral nutritional therapy, fed through the gastrointestinal tract via a catheter, tube,     catheter, or stoma, delivers the nutrients distally to the oral cavity and may reduce     intrahospital malnutrition. Enteral probes are inserted, at the bedside, through the nose or     mouth into the stomach or duodenum. Among the main complications of the use enteral probes,     we can mention: displacement of the probe and administration of diet in the respiratory tract     or microaspirations. To prevent displacement, enteral probes are attached to the skin on the     nose or forehead by the use of micropore-type adhesive. In the probe the adhesive tape is put     in the form of tie and again fixed to the nose of the patient. The enteral probes     displacement rates with this technique are around 62%; in addition, the adhesive tape can     cause discomfort, nasal necrosis, skin lesions and skin sensitivity reactions to the patient.     More recently the nasal bridle, an anchor of the enteral feeding tube located around the     nasal septum or nasal septum, has been described as more effective in securing enteral probes     position over traditional tape attachment, but is not available in our environment. In     Brazil, the feeding tube attachment device (FTAD) is available. Until now, the performance of     FTAD in relation to enteral probe safety and accidental exit rates has not been described in     the literature. Material's FTAD is composed of a layer of hydrocolloid that is adhered to the     skin on the back of the nose and a polyurethane clamp that secures the enteral probe. Thus,     there was a need to evaluate the actual success in using the traditional mode of probe     attachment. It should be noted that very little scientific evidence is available in the     literature on such care, and this is due to the lack of well-designed studies on the subject.   "
1789|NCT03262480|"     Although fluid therapy is of paramount value in anesthetic practice, there is no guideline     available for perioperative fluid management in major abdominal surgery. So, there is a need     to establish whether goal directed fluid therapy protocol is effective during radical     cystectomy and urinary diversion. A balance of perioperative fluid therapy is crucial, yet     the method to achieve this equilibrium remains a highly debated subject. Therefore, this     study will be designed to investigate the effects of two individualized goal directed fluid     therapy during radical cystectomy to encourage an effective circulating blood volume and     pressure. Accordingly, as a primary outcome, the investigators assume that stroke volume     optimization could maintain better perioperative hemodynamic stability with low incidence and     severity of hypotensive episodes together with achievement of maximal oxygenation. Hopefully     this regimen could help to decrease the possibility of perioperative tissue hypoperfusion and     the possible associated complications as a secondary outcome.   "
1809|NCT03262220|"     Total body irradiation (TBI) is a standard part of the conditioning regimen for bone marrow     transplantation (BMT). Several randomized trials have shown superior outcomes using TBI     compared with non TBI-containing regimens. Standard TBI is usually delivered over three days     for a total dose of 12 Gy with two daily fractions. However, as demonstrated by our group,     increasing the TBI dose above 10 Gy is not necessarily associated with better outcome in     patients undergoing allogenic BMT for hematologic malignancies. For this reason, patients     older than 40 or grafted after relapse are treated at our center with a reduced-dose 10 Gy     TBI regimen. This pilot study wishes to investigate in 10 patients with hematological     malignancies unfit for a standard 12 Gy TBI conditioning regimen a more targeted, conformal     form of treatment, referred as total marrow (TMI), using volumetric Arc Therapy (VMAT). Our     hypothesis is that using this technique that can allow deliver a higher total dose to the     target while at the same time assuring to the organs at risk (OAR) the same dose normally     delivered with a 10 Gy TBI we will improve the therapeutic ratio in these patients.   "
5034|NCT03219983|"     The purpose of the study is to determine if pain management after total shoulder arthroplasty     is more efficacious with ultrasound guided, continuous Interscalene block or with local     tissue infiltration with liposomal bupivacaine.      Traditionally, general anesthesia followed by narcotics has been the primary management of     pain control. However, regional anesthesia in the form of an interscalene block (ISB), a     perineural local anesthetic infusion, is commonly used and may more effectively control pain     during and after shoulder arthroplasty, with fewer side effects than narcotics.     Intraoperative benefits include better control of blood pressure and reduced need for general     anesthesia and narcotics. Depending on the type of block (single shot vs. continuous) and the     type of local anesthetic administered, pain relief may persist for 12-96 hours     postoperatively.      However, not all patients are candidates for peripheral nerve blocks. Pre-existing pulmonary     disease, previous neck surgery, cervical arthritis, neurologic disorders and obesity may     preclude ISB placement. As well, interscalene blocks are not completely benign procedures.     Systemic complications include clinically significant intraoperative hypotension,     pneumothorax, vascular injury, cardiac arrest, respiratory failure, seizure and death.     Phrenic nerve paralysis is common, although transient. Peripheral nerve injuries related to     mechanical injury, medication neurotoxicity, compression or ischemia are infrequent but may     be devastating. The experience and number of blocks performed by the anesthesiologist in     addition to adjunctive tools, such as ultrasound and/or nerve stimulators, impacts the     success of the procedure.      Continuous indwelling interscalene blocks (CISB) may provide substantial and longer pain     relief, precluding the need for perioperative narcotics. Earlier discharge post procedure and     better early range of motion are other purported benefits. However, premature catheter     failure, catheter breakage, infection, over administration of medication and extended     diaphragmatic paresis are concerns. In addition, there is a cost associated with these     procedures. The anesthesiologist fee, catheter with or without elastomeric pump, local     anesthetic, perioperative patient evaluation and treatment of any associated complications     all must be considered.      . The development of new, long acting local anesthetics, such as liposomal bupivacaine, is     potentially important in the management of perioperative pain. Liposomal bupivacaine has been     approved by the US Food and Drug Administration for local infiltration for pain relief after     bunionectomy and hemorrhoidectomy. This preparation increases the duration of local     anesthetic action by slow release from the liposome and delays the peak plasma concentration     when compared to plain bupivacaine administration. Studies have shown it to be an effective     tool for postoperative pain relief with opioid sparing effects and it has also been found to     have an acceptable adverse effect profile.   "
36874|NCT02803034|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
1790|NCT03262467|"     In patients with chronic renal failure, a well-functioning vascular access is essential for     hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular     access, due to a lower incidence of complications and better long-term patency as compared to     prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm     (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality     Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative     treatment, but precise recommendations when and how to intervene in available guidelines are     missing.      Several surgical (remodeling, resection and substitution, ligation) and endovascular     techniques have been described in the AAVF treatment, but there is currently no prospective     randomized study comparing these techniques.      In 2008, our team published the first experience with a new surgical method of AAVF treatment     - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was     validated in several studies and has shown a good long-term patency and a minimal incidence     of complications.      AAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis     (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress,     turbulent flow, endothelial damage, and thrombus formation, which should improve vascular     patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized     study comparing the effect of external porous prosthesis on AVF patency and the incidence of     postoperative complications.   "
1791|NCT03262454|"     The investigators hypothesized that local radiation therapy can enhance the effect of     anti-PD-L1 monoclonal antibody through priming T-cell effector function against cancer cells.     Described as above, The investigators concluded that modest dose of radiation to local site     prior to immunotherapy is the best to enhance T-cell-mediated immunity. Accordingly, The     investigators will investigate the combining effect of hypofractionated-sublethal dose of     radiation therapy followed by anti-PD-L1 monoclonal antibody, atezolizumab, for SCLC patients     who are recurrent or refractory for initial platinum-based chemotherapy   "
1792|NCT03262441|"     This is an open label pilot study to determine whether Mycophenolate mofetil (MMF) given over     22 months meaningfully decreases the size of participants' HIV reservoir.      In addition to primary safety endpoints, the following hypotheses regarding drug efficacy     will be tested:        1. MMF therapy will lead to a progressive decrease in reservoir size over 22 months of          treatment.        2. MMF therapy will lead to a continual shift in HIV reservoir composition from primarily          effector memory CD4+ T cells (TEM) and central memory CD4+ T cells (TCM), to primarily          stem cell like memory (TSCM) and naïve (TN) CD4+ T cells.        3. MMF will eliminate detectable measures of the HIV reservoir, including by          cell-associated DNA/mRNA and quantitative viral outgrowth allowing an experimental          interruption of ART in some enrolled participants.   "
1793|NCT03262428|"     The management of chronic conditions is a challenge for health systems worldwide,     particularly in the context of an aging population, and requires urgent improvement of health     services. Integrated care and patient empowerment represent promising solutions: offering     tailored self-management support in a collaborative framework led to good results in several     clinical contexts. Yet, large scale implementation remains a challenge. An important     limitation of existing solutions is a lack of utilization of behavioural and communication     theory for identifying the dynamics of pluridisciplinary collaboration and the interactive     effects of the activities performed by several actors involved in self-management support in     a given chronic condition. A second limitation is not involving all relevant actors in the     development of health service improvement solutions, which leads to limited programme     adoption and sustainability in routine care.      This study is part of a project that proposes to address these limitations and develop and     interdisciplinary model of collaborative care in the self-management of chronic conditions     (CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative     study that will consist of semi-structured interviews with several types of stakeholders:     patients, caregivers, and health care professionals of different specialties (e.g. general     practitioners, nurses, specialist consultants, pharmacists). The main objective of the study     is to explore the experiences and of patients, caregivers, and HCPs on how self-management     support is currently delivered in asthma, cancer and stroke (content, communication,     organisation of care), their needs related to self-management support provision, and     envisaged solutions for improving current practice. Three different chronic conditions will     be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via     grounded-theory and template analysis. It will inform the development of a theoretical model     of collaborative self-management support in chronic conditions. It will also result in three     profiles describing 'real' versus 'ideal' care processes, which will represent needs     assessment stages for future health services improvement interventions in the three     conditions.   "
1794|NCT03262415|"     The purpose of this study is to evaluate the accuracy and efficacy of the Cambridge Medical     Technologies, LLC LabPatch Continuous Glucose Monitoring (CGM) System compared to a     laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio     and Freestyle Lite.      The LabPatch system includes:        1. The LabPatch circuit chip which lies in the center of a circular push-button. The          circuit is in the form of a small chip (approximately 15.7 mm [0.618] x 15.7 mm          [0.618]) placed in contact with the skin. The chip has a telescopic micropipette which          draws interstitial fluid to be analyzed for glucose levels. The chip is also able to          measure skin temperature to ensure appropriate skin contact.        2. A Lab Patch holding device (blue box).        3. A wire that connects the chip to a laptop that continuously captures glucose data.   "
1795|NCT03262402|"     Periodontal diseases, such as chronic periodontitis (CP), frequently occur in     immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by     the HIV infection can justify the high frequency and the difficult in controlling the CP in     this group of patients, raising the possibility of additional factors associated to the     development of CP in HIV patients. The aim of this study is to determine factors that can be     involved in the CP pathogenesis in HIV patients, including Candida spp presence, and     biomarkers involved on the inflammatory response against the microorganisms.   "
1796|NCT03262389|"     Investigators are doing this study to determine which of four imaging techniques:     Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18     FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is     the best test for finding sites of active myeloma disease.   "
1797|NCT03262376|"     The objective of this acute intervention study is to examine the potential of green tea and     rhodiola to demonstrate unique and synergistic effects on oscillatory brain activity,     cognitive performance, and stress reduction (endocrine, sympathetic, and subjective     parameters) under conditions of acute stress in moderately stressed individuals   "
1830|NCT03261947|"     The purpose of this study is to confirm the safety and tolerability of TAK-931 in a cohort of     Western participants with metastatic solid tumors and to evaluate the anti-tumor activity of     TAK-931 in participants with metastatic pancreatic cancer and colorectal cancer (CRC).   "
5035|NCT03219970|"     To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele     fraction (AF) in a real-world setting.   "
1798|NCT03262363|"     The increase in the prevalence of diabetes mellitus (DM) is one of the greatest public health     challenges worldwide. Epidemiological studies have shown that DM is the leading cause of     chronic kidney disease (CKD) in patients initiating renal replacement therapy. In our     country, diabetes accounts for about 60% of all incidents of dialysis. On the other hand, CKD     is currently considered a noxious disease because patients not only have the likelihood of     progression to end-stage renal disease (ESRD), but because these renal alterations are     associated with an increased risk of cardiovascular complications and premature death for the     same cause. Most studies have focused on traditional risk factors (poor diet, physical     inactivity and obesity) for the development and progression of renal damage, and less     information exists on non-traditional factors such as oxidative stress and mainly, the low     antioxidant response that characterizes both DM and nephropathy. In addition, there is a     great variation in the susceptibility to and progression of kidney disease between different     populations that is not explained by the presence of traditional factors and that could be     triggered by genetic variations and its interaction with other components related to the     environment and lifestyle. Fortunately, there is sufficient scientific evidence that early     detection and modification of negative lifestyle factors can not only delay or halt the     progression of the renal function decline to ESRD but can also significantly reduce the     incidence of cardiovascular disease leading to premature death in most of these patients.     Therefore, it is suggested that this risk may be determined by the interaction of lifestyle     factors with the presence of susceptibility alleles, which may vary from one population to     another. It is now known that hyperglycemia causes a state of oxidative stress and     inflammation that can be counteracted by diet supplementation with some natural antioxidants     such as curcumin. It has been shown that this molecule has multiple pharmacological     properties: antioxidant, anti-inflammatory, cardioprotective, renoprotective, among others.     In clinical trials a positive effect of curcumin has been seen in the treatment of diabetes     and its complications. This has generated a relative optimism in the search for new curcumin     treatment targets where oxidative stress is of great relevance, as is the case with CKD.     However, there are still doubts about its efficacy as an adjuvant in the prevention of CKD.     Additionally, the role played by interindividual variability in genes involved in the     mechanism of action of curcumin is still incipient, more studies in this knowledge area are     necessary.   "
1799|NCT03262350|"     The purpose of this study is to assess the effects of a regular yoga practice on body image     in college women.   "
1800|NCT03262337|"     New mobile Health (mHealth) technology creates an opportunity to approach travel medicine     research in a different way, revolutionising our understanding of risks to travellers. Using     mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI),     University of Zurich (UZH), developed a TRAVEL app in collaboration with the Eidgnössische     Technische Hochschule (ETH) Zurich.      By using this new technology, an extensive collection of data (prospective collection of     individual travel behaviour and experienced health events, mapping the travel itinerary via     global positioning system (GPS), linking to publicly available local weather data and data on     disease endemicity) can be combined and an unprecedented abundance of information on travel     behaviour and experienced risks can be obtained. These data will allow a much better     understanding of travel risk profiles using cluster analysis. By simultaneously recording     health outcomes, the relationship between travel risk profiles and health events can be     assessed. In this study, the investigators will address several major shortcomings in travel     health in tropical and subtropical destinations by improving the understanding of poorly     assessed and potentially underestimated health threats (e.g. risk of accidents and injury,     mental health disorders), and travel risks specific to elderly travellers and travellers with     chronic conditions. These findings will directly feed back into individual travel advice     given by practitioners in Switzerland and finally world-wide.   "
1801|NCT03262324|"     There have previously been no validated a specific foot and ankle patient-reported outcome     measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and     adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or     surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included     testing of ﬂoor-ceiling effect, internal consistency, reproducibility, and validity.   "
1802|NCT03262311|"     The purpose of this study is to test the potential of a relatively simple serum assay that     aims to identify patient subpopulations whose curative radiotherapy outcome is likely to be     compromised by radiobiological tumour hypoxia (prognostic value) and who are most likely to     gain (predictive value) from the addition of radiation sensitiser drugs or targeted     radiotherapy dose escalation.   "
1803|NCT03262298|"     The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor     modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.   "
1804|NCT03262285|"     the investigators will compare between the endothelial cell loss after phacoemulsification     and extracapsular cataract extraction in management of senile cataract   "
1805|NCT03262272|"     Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per     group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and     patient profile.      To evaluate the different hemodialyzers and judge their extraction performances in HD and     post HDF.      Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory     status.   "
1806|NCT03262259|"     This study will evaluate effects of a multi-component, population-level intervention on     alcohol use and related harms in nine intervention cities relative to nine matched comparison     cities. Intervention components include promotion of zero- and low-alcohol beer, a social     norms marketing campaign, alcohol guidance labels, screening and brief interventions by     health providers, and other evidence-based interventions (e.g., enforcement of drink-driving     laws) determined for each city. Key outcomes of interest include alcohol-related harms such     as alcohol-related motor vehicle fatalities and violence, heavy/binge drinking, underage     drinking, and drinking and driving.   "
1807|NCT03262246|"     The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid     peptids in the walls of the arteries of young and average calibre of the brain and the     leptomeninx. The incidence of the AAC increases strongly with the age and represents a major     cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar     brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings     leading to cognitive decline.      Anatomical studies reported the presence of cortical infarcts in patients having amyloïd     deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.      However prevalence and meaning of these infarcts in patients having an AAC remain badly known     because of studies on low number of patients and the rarity of radiological analyses of these     infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread     better cognitive disorders(confusions) presented by these patients, and to develop preventive     strategies.      Besides, the risk factors of severity of the AAC are little studied.   "
1808|NCT03262233|"     The objective of the current study is to evaluate the validity of the No Shock, Predictable     Shock, Unpredictable Shock (NPU) stressor task for use as a surrogate endpoint to predict     short-term clinical outcomes among smokers during a smoking cessation attempt.   "
1810|NCT03262207|"     Recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and     that this message is crucial for the future development of the embryo. This epigenetic     signature is notably represented by methylation of genes subjected to imprinting (GSI) and     the methylation of transposable elements (TE). Data on the maintenance of the imprint and of     the control of TE accompanying human gametogenesis in a context of adult germinal testicular     cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes.      The aim of this study is to determine whether patients with seminomas in comparison with     fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes.      This study is based on the use of an existing collection of biological samples. 90 samples     will be selected and split into 3 groups:        -  Group 1: 30 sperm samples from patients with seminomatous testicular tumours        -  Group 2: 30 sperm samples from fertile patients        -  Group 3: 30 sperm samples from infertile patients      After treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they     will be analysed.   "
1811|NCT03262194|"     Human cytomegalovirus (CMV) is the leading cause of neonatal viral infection and can have a     significant impact on the neurosensory development of newborns and especially premature     infants. CMV infection can result from materno-fetal transmission during pregnancy     (congenital infection) or postnatal transmission. The prevalence of congenital CMV infection     in the newborn is estimated to be between 0.1 and 0.5%. Among the newborns in utero infected     by CMV, it is estimated that 10-15% will present symptoms at birth (hypoacousia / unilateral     or bilateral deafness, microcephaly, chorioretinitis, psychomotor retardation, etc.) and 0.5%     of them will die. 20% of infected infants, mainly symptomatic newborns, suffer permanent     sequelae, mainly loss of hearing. Many asymptomatic children at birth will present hearing     loss and other delayed neurological complications. A progressive neurosensory hearing loss     may develop for 13-15% of asymptomatic newborns at birth. Deafness is bilateral in 50% of     cases, severe in more than 50% of cases, and its occurrence is often delayed. The hearing     loss has a significant impact on the future life of the child, mainly on language acquisition     and school performance.      A systematic CMV screening is not currently recommended at birth due to the frequency of     asymptomatic forms, difficulty in fetal diagnosis and prognosis, lack of consensus for     preventive and curative treatment of the infection. New treatments are being evaluated and     encouraging results could revive the debate.      PCR from urine is the gold standard for the diagnosis of CMV infection. Urine collection is     not systematic in newborns and its realization can sometimes be difficult. On the other hand,     in children at risk (hypotrophy, prematurity, infectious risks, fetal distress or respiratory     distress at birth), gastric aspiration is systematically performed at birth to overcome     obstruction of the upper aero-digestive tract, to prevent oesophageal atresia, to avoid     inhalation by reflux and sometimes to make a bacteriological diagnosis.      Our hypothesis is that this liquid could be used for the detection of CMV infection without     adding any invasive action in newborns. Ultimately, gastric aspirate could allow for routine     CMV screening in children at risk and thus allow for appropriate care by nursing staff.The     occurrence of immediate or delayed sensory sequelae in these children would be then limited.   "
1812|NCT03262181|"     The purpose of this study is to determine differences in lower extremity landing biomechanics     and real-world physical activity between individuals with patellar tendinopathy compared to     individuals without patellar tendinopathy,and to determine the acute effects of an isometric     loading intervention on lower extremity landing biomechanics in individuals with patellar     tendinopathy.   "
1813|NCT03262168|"     This study will evaluate if the introduction of a supported exercise programme can improve     physical and psychological well-being for adults with congenital heart disease.   "
1814|NCT03262155|"     Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO /     ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS   "
1815|NCT03262142|"     This is a prospective, randomized multi-center trial investigating the impact of lower airway     infection with P. aeruginosa in COPD patients. The aim of the study is to evaluate if     targeted antibiotic therapy against P. aeruginosa can improve the prognosis in patients with     COPD.   "
1816|NCT03262129|"     Type 1 - Multiple Endocrine Neoplasia syndrome (MEN1,) is an autosomal dominant disorder     secondary to MEN1 mutations that predisposes carriers to endocrine tumors. The MEN1 gene     located on chromosome 11q13 encodes menin, a 610 amino acid protein expressed in all tissues     tested. Menin is a scaffold protein which interacts with a large number of intracellular     molecules. MEN1 disease may display various clinical associations The tumors mainly develop     from endocrine tissues and may arise from parathyroid glands, duodeno-pancreas, pituitary     gland, adrenal glands, and at a lower frequency from the bronchi and thymus. The penetrance     is very progressive but ultimately high during a lifespan.      Although the syndrome was discovered in 1903 by Erdheim and properly documented in 1954 by     Wermer, it was only in the 1970s that the variety of clinical presentations was acknowledged     and first attempts to codify treatments were made. Most published studies deals with selected     and small size populations. Thus, many aspects of the natural history of MEN1 remains unknown     as well as the optimal care of patients. In addition, although advances in genetics improved     the diagnosis of MEN1, there are still clinical forms whose attachment to the syndrome is     difficult: atypical, paucisymptomatic, forms the negative genetic diagnosis (10%). These     clinical forms need to be clarified to ensure optimum support.      This cohort relies on the Groupe d'étude des Tumeurs Endocrines (GTE) network for MEN1,     created in February 1991, and brings together clinical centers in France and Belgium (n=80)     as well as the four genetics laboratories in charge of MEN1 diagnosis. It aims at improving     the knowledge of the MEN1mainly in describing:        -  its evolution over time globally and according to the initial presentation, (          particularly accounting the risk of the occurrence of secondary MEN1 related or          unrelated tumors, and death)        -  the genotype-phenotype correlations and heritability of the disease        -  the real life management of patients and its impact on cure and survival for each type          of MEN1-related tumor        -  the impact of the NEM on the patients' daily lives, their perception of the disease and          their satisfaction with their care   "
1817|NCT03262116|"     Subjects will participate in three weeks of the bionic pancreas in the insulin-only     configuration. Each week, subjects will use a different rapid acting insulin analog --     Humalog, Novolog, or Adpidra -- in a randomized cross-over order.   "
1818|NCT03262103|"     The purpose of this study is to test an approach of stimulating the body's immune system to     attack prostate cancer. This study will test injection of a substance polylysine and     carboxymethylcellulose (Poly-ICLC, Hiltonol®)through a needle guided by MRI (magnetic     resonance imaging) ultrasound fusion technology into the prostate gland. Poly ICLC has been     used to help the body in its fight against cancer. The first aim of the study is to determine     the highest dose of a substance Poly-ICLC (Hiltonol®) that can be safely tolerated by the     study participants. The second aim of the study is to find out the toxicity or side effects     of poly-ICLC.   "
1819|NCT03262090|"     Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients,     which increases the risk of developing postoperative airway obstruction and respiratory     depression. In infants, there is a high incidence of emergence agitation (EA) after     desoflurane anesthesia. The aim of the present preliminary study was to determine the safety     and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent     postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia   "
2199|NCT03257098|"     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size     reduction of Chronic Venous Ulcers) and safety (by monitoring adverse events) of the     medicinal product to be studied after one single application on the wound surface in patients     with Chronic Venous Ulcers.   "
1820|NCT03262077|"     Due to the phenomenon of bacterial resistance, photodynamic therapy (PDT) has been studied as     an alternative to the use of antibiotics on the periodontal treatment. However, the studies     show several discrepancies between the parameters adopted for PDT, which makes it difficult     to compare the results and measure their efficacy. The objective of this research was to     investigate the tissue dosimetric parameters used in PDT for the treatment of periodontal     disease. In order to achieve this objective, the scattering pattern of light in periodontal     tissue, the concentration of methylene blue in the periodontal pockets and the number of     viable microorganisms were evaluated. This clinical trial included 30 patients with chronic     periodontitis according to the eligibility criteria. The patients were in periodontal     treatment at the Dental Clinic at the University of Nove de Julho, where the research was     carried out. Three incisors from each patient were selected for the experimental procedures.     The pattern of light scattering was observed through intraoral photographs. A laser with     emission of radiation with wavelength of 660 nm and 100 mW of power was used. The     concentration of the photosensitizer (PS) in the periodontal pockets was evaluated by     spectrometer before irradiation. Methylene blue was used as PS at the concentration of 100 μM     in two different formulation and vehicles to evaluate the drug dimerization. Then, the     procedures of irradiation of the PDT were carried out, with 3 irradiation times of 1, 3 and 5     min. The microbiological evaluation was performed from subgengival biofilms of the     periodontal pockets of the experimental sites, before and immediately after the irradiation     procedures.   "
1821|NCT03262064|"     Bronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients     have a structural abnormality of the bronchial wall that predisposes them to bacterial     infection likely due to impaired mucus clearance. A vicious cycle of chest infections and     chronic lung inflammation can lead to further damage of the bronchial wall and spread of     disease to normal areas of bystander lung.   "
1822|NCT03262051|"     Cytochromes P450, main enzymes of drug metabolism, play a prominent role in the first-pass     metabolism of oral substances. Inter-individual variability in their activity due to genetic     and environmental factors has been observed and may be associated with adverse therapeutic     outcomes (ineffectiveness or toxicity). The inflammation, whether acute or chronic, can     theoretically modulate the pharmacokinetics of drugs by modulating enzyme activity. Indeed,     in vitro data and animal models, as well as more limited data in humans, indicate a     down-regulation of CYP in the context of inflammation.      The cocktail approach developed and validated in Geneva (Geneva Cocktail) measures the     activity of several CYP simultaneously using micro-doses of probe drugs and facilitating     sampling (10uL capillary blood) on a dried blood spot.      Investigators intend to measure the activity of CYP in an acute inflammation model (hip     surgery) and chronic inflammation model (rheumatoid arthritis, RA). The effect of the     biological agent tocilizumab (anti IL-6 receptor) in a treated patient subgroup (patients     treated regardless of our study) will be measured after 3 months of treatment.      The main objective is to determine if interleukin-6 levels are correlated with the activity     of CYP450 in patients with acute (orthopedic surgery - hip) or chronic inflammation (RA).      Secondary objectives are:        -  To correlate CYPs activities with the levels of other inflammatory markers (CRP, TNF-α);        -  To assess correlation between markers of inflammation, CYP activities and the intensity          of fatigue and pain;        -  To assess if tocilizumab reverse CYP activity in patients with RA after 3 months          treatment.   "
1823|NCT03262038|"     This is a prospective randomized, double-blind, placebo-controlled study to compare the     incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV     ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group,     where pruritus and PONV are treated with PRN only medications.   "
1824|NCT03262025|"     Background: The importance of cecal pathologies lie in the fact that being the first part of     large intestine, any disease involving the cecum affects overall functioning of the large     bowel. Primary cecal pathologies presenting as acute abdomen have not been described in any     previous study in terms of presentation, management and outcome.      Objectives: The objective of this study was to identify the reported causes of primary cecal     pathologies presenting as acute abdomen and the various causes presenting in Indian setting,     to discuss morbidity and mortality associated with cecal pathologies and to critically     analyse the various management modalities employed in emergency setting.   "
1825|NCT03262012|"     A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term     Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very     Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®   "
1826|NCT03261999|"     The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of     subjects with prostate cancer, when administered as two injections twelve weeks apart.   "
1827|NCT03261986|"     The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome     measures to evaluate early post-operative implant stability and the clinical performance of     Stryker's Trident II Acetabular Cup.   "
1828|NCT03261973|"     Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy     employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior     wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very     common and occurs in up to 40% of AF ablations per some studies. When significant thermal     injury to the esophagus occurs, two significant complications can arise: 1) the formation of     an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of     fistula is rare, it is a very important complication since it is often fatal. Currently     luminal esophageal temperature monitoring is the most commonly employed modality to prevent     such injury. However, there are limitations to its use, and atrio-esophageal fistulas     continue to be a major problem in AF ablation even when using esophageal temperature     monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or     Esophagogastroduodenoscopy (EGD) probe has been described in the literature, but the     effectiveness and practicality of these techniques are suboptimal, and have therefore     precluded their use in routine clinical practice. Recently, esophageal deviation using     off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the     randomized double-blind multicenter study Deviating the Esophagus in Atrial Fibrillation     Ablation (DEVIATE-AF). In that study the standard practice (i.e., use of luminal esophageal     temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment.     The results were very encouraging showing that esophageal deviation allowed for significant     reductions in esophageal temperature and proportion of premature ablation terminations.     Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which     was not the case in the control group. One major limitation in the DEVIATE-AF trial was that     off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in     Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the     esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences,     Minneapolis, MN).   "
1829|NCT03261960|"     The objective of this study is to compare the safety and efficacy of BLI4700 bowel     preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations     prior to colonoscopy in adult patients.   "
1834|NCT03261895|"     This randomized controlled trial aims to investigate the effectiveness of an integrative     medicine (traditional Chinese medicine and western medicine) based structured education     programme for newly diagnosed type 2 diabetes patients. The theoretical frame of this study     is based on the health belief model and self efficacy theory. The hypotheses of this study     are: 1) Participants in the intervention group will have higher level of self-management     behaviour after intervention compared to participants in the control group; 2) Participants     in the intervention group will have better diabetes knowledge after intervention compared to     participants in the control group; 3) Participants in the intervention group will have higher     level of self-efficacy after intervention compared to participants in the control group; 4)     Participants in the intervention group will be less depressed after intervention compared to     participants in the control group; 5) Participants in the intervention group will have better     QOL after intervention compared to participants in the control group; 6) Participants in the     intervention group will gain greater reduction in HbA1c after intervention compared to     participants in the control group; 7) Participants in the intervention group will gain     greater reduction in fasting blood glucose after intervention compared to participants in the     control group; 8) Participants in the intervention group will gain greater reduction in BP     after intervention compared to participants in the control group; 9) Participants in the     intervention group will gain greater reduction in BMI after intervention compared to     participants in the control group.   "
1835|NCT03261882|"     Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage     relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be     changing over time. The objective of this study was to examine whether the relationship     between nativity and overweight/obesity has changed over time among Mexican-American children     and to investigate the implications of this pattern on overweight/obesity disparities     relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and     non-Hispanic white children ages 4-17 years participating in the National Health and     Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators     used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by     nativity status adjusting for age, sex, householder marital status, householder education,     survey period and a nativity by survey period interaction. The investigators also tested     another covariate-adjusted model with a 3-level ethnicity-nativity variable that included     Whites and an ethnicity-nativity by survey period interaction.   "
1836|NCT03261869|"     this study evaluates the effect of cold application after impacted third molar extractions.     Patients have bilateral impacted third molar tooth included in this study. Patients do not     applied cold after extraction of third molar on one side and applied cold cold after     extraction of third molar on the other side.   "
1837|NCT03261856|"     Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative;     these patients are labeled as IBS. In these patients, whether testing for carbohydrate     malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear. We aim to     assess the prevalence of SIBO, fructose and lactose intolerance, the usefulness of breath     tests, and predictive value of pre-test symptoms.   "
1838|NCT03261843|"     the study aims to determine the effect of using Autologous platelet rich plasma on both the     quality & rate of posterior lumbar interbody fusion & its outcome on the Patient regarding     postoperative lumbar pain & functional outcome   "
1839|NCT03261830|"     The aim of this study is to determine if antibiotics affect the outcome after percutaneous     surgery for pediatric supracondylar humerus fractures. The patient population will be     recruited from the cohort presenting to Women and Children's Hospital for percutaneous     fixation of pediatric supracondylar humerus fractures who meet the eligibility criteria and     consent to taking part in the study. Patients will be followed up for 3-6 weeks depending on     age, and will be evaluated on the presence or absence superficial or deep infection, VAS pain     scores, time to healing, need for repeat casting, and loss of fixation.   "
1840|NCT03261817|"     In this study, an APA program by web (e-APA) will be offered to two groups of participants     (21 patients and 21 healthy volunteers (HV)) in remote video (use of the SAPATIC (Santé     Activités Physiques Adaptées utilisant les Technologies de l'Information et de la     Communication) platform developed by the company V@SI). At the same time, two control groups,     a group of 21 patients and a group of 21 HV will undergo an health education program (HE)     through the collaborative SAPATIC health platform of V@Si and will constitute the control     groups. The content of the APA sessions will be administered by V@Si. This program offers     content aimed to improve aerobic capacity and muscular strength while relying on the     motivation of the participants   "
1841|NCT03261804|"     To determine the effect of performing internal vaginal douching on the frequency and severity     and type of vaginal infections in IUD users   "
1842|NCT03261791|"     In this phase 2 study, we aim to evaluate the effects and safety of adjuvant apatinib therapy     for the patients who underwent R0 resection for hepatocellular carcinoma with portal vein     tumor thrombus.   "
1843|NCT03261778|"     In a randomised prospective comparative Trial the investigators aim to compare the     conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional     sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.      The sling/brace will be worn for 6 weeks and the patients will be regularly checked     clinically and radiologically.The investigators are interested in differences of shoulder     function, Patient satisfaction as well as cosmetic and radiological results.   "
1844|NCT03261765|"     The rate of cesarean section deliveries has increased dramatically worldwide in the last     decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to     2007 data and is thought to be over 50% at present. The reasons for this include advanced age     of primigravida, a wide range of indications, patient requests, the frequency of women with     previous cesareans, women's rejections to offers of sterilization, and the common usage of     assisted reproductive techniques   "
1845|NCT03261752|"     Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an     estimated 1.3 million new cases and >500,000 mortality ⁄ year . is the fourth leading cause     of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the     worldwide   "
1846|NCT03261739|"     BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate     the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.   "
1847|NCT03261726|"     Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with     progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth     on serial MRI scans typically lead to deafness in the affected ear over time. Radiation     (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in ~80% while surgery     (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small     tumors, although initial hearing preservation by both modalities may fail over time. Surgical     resection via the translabyrinthine approach is the safest way to remove many of these     tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply     (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at     risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies     (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be     required later. The incidence of this is 46% in our patients. This study seeks to determine     the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing     translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant     at a later time.   "
1848|NCT03261713|"     Virtual reality (VR) training (VRT) uses computer software to track a user's movements and     allow them to interact with a game presented on a TV. It is fun and engaging and may     encourage the user to do more exercise. VRT is increasingly being used for rehabilitation     after stroke. Patients often require ongoing therapy post-discharge from inpatient     rehabilitation. Outpatient therapy may be unavailable due to waiting lists, transportation     issues, distance etc.; therefore, home-based VRT may be the answer. Our objectives are to     determine: 1) the feasibility of home-based VRT for stroke patients after discharge from     hospital-based rehabilitation, and 2) the feasibility of a battery of outcome measures. Forty     stroke rehabilitation patients will be recruited over 18 months and randomize them to     experimental or control groups. VRT participants will be introduced to VRT at the hospital     and a VRT system will be set up in their homes shortly after discharge. Control participants     will be provided with games and apps on an iPad focusing on cognition and fine motor skills.     Participants will be instructed to perform 30 minutes of VRT 5 days a week for 6 weeks.     Training will be monitored remotely. Both groups will receive weekly phone calls to review     their home activity and answer questions. Measurements will be made of standing balance and     general function before and after training, and feasibility (compliance, enjoyment, safety).   "
1849|NCT03261700|"     Intimate partner violence (IPV) is a major health concern for women Veterans. IPV is     associated with numerous physical and mental health conditions. VHA is implementing IPV     screening programs to identify female patients who experience past-year IPV. Despite strong     evidence that screening increases detection of IPV, less is established about how to     intervene following IPV disclosure in health care settings, in order to improve health     outcomes. Existing healthcare-based interventions result in minimal effects on health and     well-being, likely because they are too brief and generic.      In response, the PI has developed Recovering from IPV through Strengths and Empowerment     (RISE), based on the IPV-related health care needs and preferences of women Veterans. RISE is     designed to be delivered in primary care and is an individualized, variable-length,     modular-based intervention that addresses        -  safety planning;        -  education on the health effects of IPV;        -  increasing coping skills and self-care;        -  enhancing social support;        -  making difficult decisions; and        -  connecting with resources. This study is aimed at refining and evaluating RISE for use          with female VA patients who have experienced past-year IPV. This brief counseling          intervention is intended to be administered in conjunction with primary care, as this is          a frequent point of healthcare contact for women Veterans and where disclosure of IPV is          most prevalent.   "
1850|NCT03261687|"     This study aimed to address whether a water exercise programme improves pain and quality of     life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise     programme and the feasibility of undertaking a large-scale research programme.   "
1851|NCT03261674|"     The purpose of this clinical trial is to assess the relative efficacy of two     non-pharmacological interventions for insomnia in Veterans suffering from chronic mild     traumatic brain injury (mTBI).   "
1852|NCT03261661|"     The purpose of the proposed studies is to examine a reading intervention for fourth grade     students with reading difficulties that integrate work in mindset (beliefs about whether     abilities are innate or can be developed) with the academic component of reading.     Specifically, the investigators will examine the extent to which integrating mindset     intervention improves student response to reading intervention. The investigators will use     previous research in intensive reading intervention for students with reading difficulties in     the upper elementary grades to examine an intervention that addresses reading skill deficits,     while also providing mindset training along with (Study 1) or embedded in (Study 2) the     reading intervention. It is hypothesized that students in the reading intervention with     mindset conditions will improve their reading outcomes more than students in the reading     intervention only and business as usual groups.   "
1854|NCT03261635|"     To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides     additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV)     in age-related macular degeneration.   "
1866|NCT03261479|"     We are proposing a two-stage, prospective, cohort study of 138 subjects > 28 days old and <     18 years old with respiratory distress, already getting a chest x-ray as part of their     routine clinical care, who will get thermal pictures of their chest at the Massachusetts     General Hospital (MGH) Emergency Department, Pediatric Wards, and Pediatric Intensive Care     Unit. The thermal cameras will measure skin temperature, by taking a picture, in a     non-contact way. We will recruit 138 patients using the FLIR ONE thermal imaging camera for     iPhone and the newly designed irPNA application. The FLIR ONE thermal imaging camera will be     attached to a study-designated iPhone which will only have the ability to take pictures. This     phone will not have the capability to make calls or use the internet. The iPhone will be     password protected, as encrypted by Partners regulations. Demographic and diagnostic data     will be collected from patient charts.   "
4833|NCT03222609|"     This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and     tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.   "
11483|NCT03135600|"     The aim of this study is to investigate the influence of running to kinematic parameters of     patients with anterior cruciate ligament.   "
1855|NCT03261622|"     Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient     treatment option for faecal incontinence (FI).      In a selected patient group we have evidence that 90% of patients will have a successful test     period (≥50% reduction in incontinence episodes). If preoperative there is motor response on     at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP.      Hypotheses In a selected patient group suffering from faecal incontinence a one-stage     permanent implant will be possible. The functional results will be improved as more time can     be spent finding the optimal pacemaker settings as the risk of infection is reduced compared     to the stage implant. One-Stage implantation gives the opportunity to test the amount of     placebo effect with SNS.      During the first 3 months postoperative patients will be randomized to either stimulation     amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at     0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2     pattern. After the initial 3 months the stimulation amplitude is increased to sensory     threshold. After six months the project ends and the number of patients achieving the 50%     improvement in incontinence episodes are evaluated.   "
1856|NCT03261609|"     The purpose of the HAPI project is to study the overall health of preterm infants once they     reach adulthood. The investigators would like to compare the health of adults born preterm     with that of adults born full-term. They would also like to find the early signs, or     biomarkers, of chronic diseases such as high blood pressure, diabetes, osteoporosis, and     chronic lung diseases.      Such biomarkers would allow for early diagnosis and prevention. Furthermore, the     investigators would like to understand why some people born preterm are more likely to     develop chronic disease. They believe that inflammation and oxidative stress may play a part.     Oxidative stress is present when the body is not able to defend itself against oxygen-derived     products that can damage our cells.      To carry out this study, the investigators will examine 6 aspects of the health: (1) heart     and circulation, (2) kidneys, (3) lungs, (4) metabolism - sugars and fats in the blood, (5)     bones, and (6) eyes.   "
1857|NCT03261596|"     The Ghana study will hypothesize that both the multiple dose and single dose of mebendazole     will achieve effective cure rates against hookworm among children and adolescents. This study     is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for     hookworm, tribendimidine.   "
1858|NCT03261583|"     Observational study.   "
1859|NCT03261570|"     Postural tachycardia syndrome (POTS), is the chronic form of orthostatic intolerance     associated with excessive upright tachycardia, and occurs predominantly in young females     (>85%). Among its most troubling symptoms are lightheadedness, fatigue, and decreased memory     often called brain fog by patients. Task-related neurovascular coupling (NVC) links neural     activity to an increase in CBF known as functional hyperemia. Although memory task     performance and NVC deteriorated with angle of tilt in POTS but not healthy controls,     cerebral blood flow (CBF) remained similar to control. Instead, the investigators observed     extensive narrow band low frequency (0.07-0.13 Hz) oscillations in BP (OBP) that entrained     and amplified oscillations in CBF (OCBF). OBP and OCBF increased with tilt angle and caused     impaired working memory and reduced functional hyperemia. The cardiovagal baroreflex couples     BP to HR to buffer BP changes. The investigators hypothesize that the cardiovagal baroreflex     becomes progressively impaired with orthostasis in POTS, but not in healthy volunteers, and     accounts for OBP, OCBF, and loss of NVC; further, improving the baroreflex reduces OBP, OCBF     and Brain Fog in POTS.   "
1860|NCT03261557|"     Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended     psychological interventions to improve symptomatology and functional recovery in psychosis.     In addition, CBT may reduce hyperactivation of the brain structures responsible for the     stress response. In patients with early onset psychotic disorder (EOP) there are not any     previous controlled study that has analyzed the efficacy of this type of intervention.      The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional     improvement after the treatment in patients with EOP. The study will also examine the     potential effect of the intervention on neurobiological stress markers.   "
1861|NCT03261544|"     The purpose of this study is to assess the functional outcomes in patients undergoing     proximal femur resection and reconstruction with an endoprosthesis, based on the abductor     muscle repair technique. The investigators hypothesize that those patients who receive     reattachment of the abductors directly into the prosthesis will have better functional     outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective,     and reproducible method to assess abductor function at clinical post-operative visits through     plain radiographs.   "
1862|NCT03261531|"     Investigators are doing this research study to find out the effect of T6 dermatomal     electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)     unit) on appetite and weight loss.   "
1863|NCT03261518|"     In this study, the investigators aimed to evaluate the incidence of vena cava inferior     diamater on ultrasound guidance of intravascular volume before diagnosis of contrast      - enhanced CT for diagnostic purposes in ileus patients and to investigate the incidence and     risk of developing contrast nephropathy due to contrast - enhanced CT.   "
1864|NCT03261505|"     The aim of this study is to investigate brain response and connectivity changes evoked by     video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee     osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body     interaction, imagery, and acupuncture.   "
1865|NCT03261492|"     The goal of SAGE is to determine if a garden-based curriculum can increase physical activity     and improve nutrition in young children at early care and education centers (ECEC) throughout     Phoenix   "
1877|NCT03261336|"     The aim of this study is to estimate the PSA response rate with the use of ketoconazole     (400mg QD + hydrocortisone 20mg AM, 10 mg PM) among men with CRPC in whom disease has     progressed despite abiraterone   "
1878|NCT03261323|"     The purpose of this study is to:        1. Evaluate whether immediate or delayed reconstruction should be offered for breast          reconstruction candidates with higher risk for surgical complications by comparing          complications, quality of life, and hospital costs        2. Determine the efficacy of risk reduction strategies for breast reconstruction patients          with higher risk for surgical complications   "
5307|NCT03216408|"     This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in     adults with moderate to severe glabellar lines.   "
1867|NCT03261466|"     Obesity is a major, public health concern that affects at least 400 million individuals and     is associated with severe disorders including diabetes and cancers. Worldwide, the prevalence     of overweight and obesity combined in children, adolescents and youth, between 1980 and 2013,     increased to 47.1%, with alarming data also in developing countries. Obesity is often caused     by imbalance between excessive caloric intake and reduced physical activity.      Recently, microbial changes in the human gut was proposed to be another possible cause of     obesity and it was found that the gut microbes from fecal samples contained 3.3 million     non-redundant microbial genes. However, it is still poorly understood how the dynamics and     composition of the intestinal microbiota are affected by diet or other lifestyle factors.     Moreover it has been difficult to characterize the composition of the human gut microbiota     due to large variations between individuals.      The role of the digestive microbiota in the human body is still largely unknown, but the     bacteria of the gut flora do contribute enzymes that are absent in humans for food digestion.     Moreover, the link between obesity and the microbiota is likely to be more sophisticated than     the simple phylum-level Bacteroidetes: Firmicutes ratio that was initially identified, and it     is likely to involve a microbiota-diet interaction.      Obese and lean subjects presented increased levels of different bacterial populations. It is     hypothesized that the obese microbiome is set up to extract more calories from the daily     intake when compared to the microbiome of lean counterparts. In addition, a caloric diet     restriction impacted the composition of the gut microbiota in obese/overweight individuals     and weight loss.      In lean subjects there are Coriobacteriaceae, Lactobacillus, Enterococcus, Faecalibacterium     prausnitzii, Prevotella, Clostridium Eubacterium, E. coli and Staphilococcus. By contrast,     Bifidobacterium, Methanobrevibacter, Xylanibacter, Bacteroides characterize the composition     of lean gut microbiota.      For this reason, in a cohort of obese paediatric subjects with visceral adiposity, the aim of     the study is to assess the efficacy of a supplementation with probiotic bifidobacteria with     respect to a conventional treatment on weight loss and improvement of cardio-metabolic risk     factors.   "
1868|NCT03261453|"     The primary objective of this study is to demonstrate the safety and efficacy of the Elipse     Gastric Balloon System for the treatment of obese adults.   "
1869|NCT03261440|"     Weaning patients off ventilation in an ICU is sometimes difficult, because of three major     inter-related etiologies: impaired lung, heart and diaphragm function. In this context,     ultrasonography during tests to wean patients off ventilation could make it possible to     diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus     reduce the number of failures at extubation.      The study will be carried out in 100 patients on mechanical ventilation following abdominal     or heart surgery, who will have echocardiography, and pulmonary and diaphragm     ultrasonography.   "
1870|NCT03261427|"     The purpose of this trial to compare the pharmacokinetic characteristics of     YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin     Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2,     Vd/f, CL/f.   "
1871|NCT03261414|"     The aim of this study will be to show a decrease in postoperative morphine consumption by the     practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal     resection for Crohn's disease   "
1872|NCT03261401|"     The primary purpose of this study is to investigate the safety and tolerability of M5717 and     to characterize the Pharmacokinetics /Pharmacodynamic relationship between M5717 PK and     parasite clearance in healthy subjects following infection with Plasmodium falciparum.   "
1873|NCT03261388|"     At Courage Kenny Rehabilitation Institute, rehabilitation for individuals with spinal cord     injury (SCI) is being led by the NIH funded NeuroRecovery Network (NRN) Community Fitness and     Wellness Program through the Activity-Based Locomotor Exercise Program (ABLE). Any individual     with a spinal cord injury who is eligible for the ABLE Program is eligible for participation     in the NeuroRecovery Network Research Project (NRN). The purpose of the ABLE POWER Study is     to evaluate the effectiveness of activity-based locomotor exercise programs in individuals     with SCI through a wait-list controlled design. Individuals who have a spinal cord injury and     are on the wait list for ABLE will be enrolled in this project for a year while they wait for     an opening in the ABLE program. Changes that occur while participants are on the wait list     will be compared to changes that occur after they are enrolled in ABLE. A difference in the     rate of improvement after enrollment in the intervention would be attributed to the ABLE     intervention. Individuals participating in the ABLE program will receive the ABLE     intervention regardless of participation in the ABLE POWER research study. In this design,     there will be two measures in the year prior to enrollment in ABLE, and two measures in the     year after enrollment, and the two time periods would be compared to the data collected at     enrollment into ABLE.   "
1874|NCT03261375|"     This is a multicentre clinical trial to evaluate safety and efficacy of renal denervation     system in treatment of hypertension. Hypertensive patients who meet enrollment criteria will     be randomized into treatment group who will receive standardized drugs and renal denervation     treatments, or control group who will receive standardized drugs and a sham procedure (renal     artery angiography only without denervation). The patients will be monitored for blood     pressure changes and any adverse events for 6 months. The safety and efficacy of the device     will be evaluated by comparing blood pressure levels and adverse event episodes between the     two groups.   "
1875|NCT03261362|"     The purpose of this study is to clarify the role of the branched-chain amino acids in the     development of Insulin resistance in patients with diabetes   "
1876|NCT03261349|"     We and other investigators have revealed an association between Hepatitis C virus (HCV)     seropositivity and an increased risk of developing marginal zone B-cell lymphoma (MZ),     lymphoplasmacytic lymphoma (LPL, also known as Waldenström's macroglobulinemia), follicular     lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL). The sustained virologic response     (SVR) to treatment with interferon or pegylated (Peg)IFN with ribavirin was closely     associated with the regression of HCV-associated B-cell NHL (mainly MZL, and LPL).      Currently, the second-generation direct-acting antiviral agents (DAAs), such as sofosbuvir,     have been shown to have a higher cure rate, less side effects, and a shorter duration of     therapy for chronic HCV infection. After the approval of DAA for HCV therapy, several recent     anecdotal case reports showed that indolent low-grade B-cell NHLs regressed after HCV     clearance by DAAs. It is noted that the time to complete remission of these lymphomas was     around 20 to 24 weeks after starting DAAs. These findings indicate that DAAs can eradicate     the trigger of lymphomagenesis by curing chronic HCV infection.      Because DAAs are more potent and efficient than pegylated (Peg) interferon plus ribavirin and     well-tolerated for the treatment of HCV infection, it is reasonable to use DAAs as the     frontline treatment for HCV-positive patients with indolent B-cell NHL, such as MZL, LPL, and     low-grade FL, who do not require immediate cytoreductive therapy. The aim of this proposal is     to assess whether Harvoni® (ledipasvir and sofosbuvir) could eradicate HCV and lead to     durable complete remission of these lymphomas..   "
14704|NCT03092999|"     Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and     tolerability of BAY1002670 (vilaprisan)   "
1880|NCT03261297|"     Chronic diarrhea is defined as stool volume of more than 10g/kg/day in toddlers/infants and     greater than 200 g/day in older children that lasts for 14 days or more.      Chronic diarrhea has many of causes can calcified as infectious & noninfectious causes.        -  Infectious causes as: - Escherichia coli, Giardia Lamblia, tuberculosis, Clostridium          difficile & Shigella.        -  Noninfectious causes as(Abnormal digestive processes- Nutrient Mal -absorption- Immune/          inflammatory- Defects of electrolyte And metaboliteTransport- Motility disorders-          Diarrhea associated With exogenous substances)      There are four basic pathophysiological categories of diarrhea: as ( osmotic diarrhea-     secretory diarrheas- motility related diarrhea- Inflammatory diarrhea)   "
1881|NCT03261284|"     This was a prospective, three arms, randomized controlled study.   "
1882|NCT03261271|"     The purpose of this study is to test how a weight management program affects substances in     the blood called biomarkers that can show the presence or severity of cancer, compared to a     standardized diet and exercise educational flyer.   "
1883|NCT03261258|"     In the vast majority of cases, the person of trust (or contact person) is not designated by     the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team     thus identifies a person who 1) may not be the person the patient would have designated and     2) may not be the most suitable to take on this responsibility. Though the first point is not     easy, the main difficulty for the clinician is to know if he is dealing with the right     person for the job, meaning a person who is able to take on the responsibility of the     contact person. This is a heavy responsibility in terms of the information given, of passing     on this information to relatives and friends, of consulting the doctors, of help or support     in medical decisions, etc. This responsibility may also be difficult for one person alone to     take on and it may be helpful to share it between several friends or relatives. In a princeps     study (QUENOT, 2015), it was shown that the process used by the healthcare team to designate     a contact person was based on criteria such as knowledge of the wishes and values of the     patient, the strength of the relationship with the patient, and the person of trust     designated before admission to the ICU. However, we do not know what criteria are used by the     patients themselves or those used by their close friends and relatives. This study will make     it possible to determine and to measure the possible differences between the criteria used by     the ICU healthcare team (REPERE I), those used by patients (REPERE III) and finally, those     used by close friends and relatives (REPERE II).      In order to do this, 300 persons (150 patients and 150 relatives/friends) will complete     questionnaires.   "
1884|NCT03261245|"     This retrospective study aimed to analyse the relationship between multi-exposure to noise     and air pollution the onset of hypertension disorders during pregnancy      It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and     2009 split into two groups:        -  530 cases (women who experienced hypertension disorders during pregnancy        -  2120 controls (women who did not experience a hypertension disorder during pregnancy)   "
1885|NCT03261232|"     Through this retrospective observational study (over 4 years; period analysed: 1st January     2011 to 31st December 2014), we looked for prognostic factors associated with better survival     in refractory cardiac arrest by:        -  assessing the overall survival rate        -  evaluating the frequency of intra et extra-hospital events and by comparing these with          the survival rate        -  studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and          blood pH in the different groups.   "
1886|NCT03261219|"     Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced     Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next     pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary     exacerbation.      FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF     patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials     because it is an acute indicator of worsening or improving lung function.   "
1887|NCT03261206|"     The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is     non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.   "
1888|NCT03261193|"     Comparison of standard post-operative cesarean surgery pain management with regional post-op     pain control.   "
1889|NCT03261180|"     This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in     improving surgery recovery in patients with head and neck cancer. Adding a nutritional     supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head     and neck cancer surgery may help to decrease the number of wound complications after surgery.   "
1909|NCT03260920|"     The purpose of this study is to assess the safety, tolerability and effects on behaviour of     Syntocinon given intranasally (by a spray into the nostrils) compared to placebo (an inactive     saline substance that contains no medication) in participants with frontotemporal     dementia/Pick's disease. This study will take place in approximately 15 centres across Canada     and the United States. Approximately 112 patients in total will be enrolled in this study. In     the first phase we will examine which of three different dosing schedules of oxytocin may be     more effective. In the second phase of the study, patients entering the study will be     randomized to the oxytocin dosing schedule that appeared most effective in the first phase.   "
1910|NCT03260907|"     The purpose of this study is to verify the efficacy and safety of electroacupuncture     treatment of postmenopausal women with overactive bladder (OAB).   "
23019|NCT02984306|"     Examining the effect of four weeks of cherry powder supplementation on flow mediated     dilatation   "
1924|NCT03260725|"     The present study is leveraging a randomized-controlled design to evaluate an Internet-based     format for the delivery of Parent-Child Interaction Therapy (I-PCIT). Drawing on     videoteleconferencing technology, this format affords real-time interactions for the     provision of care traditionally delivered in person, regardless of a family's geographic     proximity to a mental health facility. Moreover, drawing on technological innovation to     deliver interventions directly to families in their natural settings may extend the     ecological validity of PCIT, as treatment is delivered in the very context in which child     problems occur. Families seeking treatment for early child disruptive behavior problems     (N=40) are being randomly assigned to either receive Internet-delivered PCIT or clinic-based     PCIT. Outcomes and feasibility/acceptability will be assessed across the treatment phase as     well as at post-treatment and 6-month follow-up.   "
1891|NCT03261154|"     Incidence of End Stage Renal Disease (ESRD) amongst elderly patient group is continuously     increasing with population aging progressing. Mineral and bone disorder (MBD) is a common     complication caused by ESRD, it raises the incidence of cardiovascular disease (CVD) in     hemodialysis patients, as well as mortality.      Joint effects of Kidney failure and aging on elderly hemodialysis patients make the     contribution factors of CKD-MBD quite complex, and it also leads to differences in clinic     manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients.     Since not much studies had been done for this specific subject, thus, research on elderly     patients who is taking Maintenance hemodialysis is very necessary. This study is a     retrospective research to identify optimized target value of Calcium and Phosphorus for     elderly patients taking maintenance hemodialysis and hence provide guidance for clinical     practices. The data for this study will be provided by Beijing Blood Purification Quality     Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices     will be collected amongst elderly patients who were elder than 65 years and was taking     maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016. Relationship between     Calcium level, Phosphorus level, iPTH index, all-cause mortality and CVD caused mortality     will be analyzed to identify optimized range of target Calcium levels, Phosphorus level for     hemodialysis treatment   "
1892|NCT03261141|"     The aim of this study is to assess the relationship between The Arabic Pediatric Voice     Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis     of voice of dysphonic children. This is important to provide an efficient therapeutic     strategy for these children.   "
1893|NCT03261128|"     Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence     of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a     self-administered questionnaire carried out by the patient before each chemotherapy cure. The     objective is to secure the quality of patient care and to detect the appearance and / or     aggravation of geriatric fragilities.   "
1894|NCT03261115|"     The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia     against the use of no topical agent during buccal infiltration in maxillary anterior teeth.     The rationale behind this comparison is to evaluate the practical, clinical outcome of not     using any topical agent if in fact topical anesthesia does not reduce pain as reported by     various studies and if consequently its usage was to be discontinued.   "
1895|NCT03261102|"     To investigate the influence of early therapeutic drug monitoring and dose optimization on     disease outcome in Crohn's patients treated with Adalimumab.   "
1896|NCT03261089|"     Cardiovascular disease remains the leading cause of death in the United States. Mortality     rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially     comatose. Of those who survive, 50% are left with a permanent neurological disability, and     only 10% are able to resume their former lifestyle. Early prognosis of comatose patients     after cardiac arrest is critical for management of these patients, yet predicting outcome for     these patients remains quite challenging.      The primary study objective of MOCHA is to develop an accurate and reliable assessment     algorithm for determining neurologic prognosis in patients initially unconscious (no eye     opening, GCS-M<6 and not following commands) post-cardiac arrest, using multiple prognostic     modalities at standardized time points.   "
1897|NCT03261076|"     The current literature on academic skill difficulties, whether considered as part of the     continuum of ability or as a specific learning disability (LD), indicates that these problems     often coexist with conduct problems and juvenile delinquency, and are risk factors for     initial law-breaking behavior and for its persistence. However, less is understood about how     this relationship develops. It is these broad questions that this project seeks to address.     First, what is the causal pathway? Does LD cause delinquency, delinquency cause LD, or are     both caused by something else? And can big data analytics applied to statewide datasets of     information about juvenile justice (JJ) involvement help to answer this question? Second, as     it is known that learning to read and do math (and thus becoming more employable) increases     the likelihood of desistance (i.e., not committing any more illegal acts), what are the     necessary parts of an intervention designed to teach these skills? And what role might     technology play in such an intervention? To answer these questions, we will implement a study     that includes two components, (a) a big data component and (b) an intervention component. For     (a), we will work with a large historical dataset from the Harris County Juvenile Probation     Department. For (b), we will work, in total, with 192 (48 per year) delinquent youth with     severe LD in residential placement. These individuals, in a nonconcurrent multiple baseline     design, will be offered an educational therapy designed to address severe reading problems in     juvenile detainees using a novel mixed media intervention in which the person-to-person     intensive 1:1 component is completed while youth are in residential settings (24 sessions,     delivered in 90 minute settings 3 times a week) and a gamified educational smartphone     learning tool follow-up completed upon release (with appropriate network fidelity monitoring     and participant reinforcement). The person-to-person component is developed specifically for     juvenile offenders with severe LD, combining two well-established and highly-regarded     intervention programs designed to systematically build students' repertoire of     grapheme-phoneme correspondence rules as well as develop comprehensive reading skills, from     beginning reading to proficiency.   "
1898|NCT03261063|"     The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland     China.   "
1899|NCT03261050|"     Most people with an eating disorder (ED) do not receive good treatment. The investigators     have developed a new brief group treatment that is supposed to work by reducing how much     women with an ED value the impossible thinness standard promoted by the media and how much     they value/crave binge foods. The investigators want to test whether the treatment actually     changes those two mechanisms using brain scan data, which is more objective than completing     questionnaires and even interviews.      In the first phase of the study (R61), the investigators will compare women in the treatment     versus those on a wait-list. If the investigators can show that the treatment works (does     what the investigators think it does) compared to no active treatment (women will be allowed     to seek and receive outside help but investigators will not provide it until after the     wait-list), investigators will conduct the second phase of study (R33),where they will     randomly assign women with an ED to either the new treatment or to a group treatment that     represents what many college mental health clinics provide to their clients with ED.   "
1911|NCT03260894|"     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus     epacadostat compared to sunitinib or pazopanib in participants with locally     advanced/metastatic renal cell carcinoma (mRCC) with clear cell component who have not     received prior systemic therapy for their mRCC.   "
2200|NCT03257085|"     Pilot study to compare the impact of following a low-carbohydrate, high-fat diet versus     following a high-carbohydrates, moderate-fat diet (UK dietary guidelines) on cardiometabolic     risk markers and associated behaviours in a normal-weight and overweight adult population.   "
1900|NCT03261037|"     This international clinical study will enroll participants with a suspected diagnosis of     IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the     peri-diagnostic period. This objective will be achieved using a multidimensional approach     assessing changes in pulmonary function, measured by daily handheld spirometry and site     spirometry as well as assessing physical functional capacity at home (accelerometry) and at     site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity     assessments are not routinely performed in this participant population. By following     participants' lung function before and after diagnosis using home spirometry, levels of     physical activity, as well as self-assessment data from the participants (patient reported     outcomes; PRO), the study would provide potentially more rapid information on disease     behavior and eventually progression compared to usual clinic measurements that occur only     every 3-6 months. By receiving data from daily handheld spirometry measurements, treating     physicians may have an improved chance of detecting earlier and outside of hospital visits a     decline in lung function that could potentially lead to improvements in both diagnosis and     treatment for participants with IPF/ILD.   "
1901|NCT03261024|"     This study is a Randomized clinical trial comparing the effectiveness of two different     mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly     divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both     group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and     dental models will be taken for each patients pre and post -retraction. Following complete     anterior segment retraction, the rate and duration of retraction will be evaluated for both     groups as well as patient satisfaction with treatment. Changes in incisors inclination and     soft tissue as well as anchorage loss will be also assessed.   "
1902|NCT03261011|"     This study is to characterize the safety, tolerability, pharmacokinetics (PK),     immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK104 as a single agent in     adult subjects with advanced solid tumor malignancies. The study consists of a dose     escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended     Phase 2 dose (RP2D) for AK104 as a single agent, and a dose expansion phase (Phase 1b) which     will characterize treatment of AK104 as a single agent at the MTD or RP2D.   "
1903|NCT03260998|"     Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by     T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of     diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of     vascular and neuropathic complications that are seen in patients with diabetes mellitus type     1.   "
1904|NCT03260985|"     This is a demonstration project focused on translating neuroscience insights into clinical     practice. The researchers will evaluate how neuroscience assessments may be applied in the     clinical setting to help inform care decisions. The aim of the study is to undertake a     pragmatic pilot trial to assess whether the inclusion of structured feedback from     neuroscience assessments has an effect on improving patient outcomes. The study will     investigate how neuroscience assessments can be integrated into and improve clinical care.     The impact of sharing information and conclusions from these assessments with psychiatric     providers will be explored. Outcomes will include symptoms, social/occupational function and     qualify of life.   "
1905|NCT03260972|"     Objective The objective of this study is to test the hypothesis that instillation of     intra-abdominal chloroprocaine during cesarean deliveries is associated with decreased     postoperative pain and nausea compared to placebo, without increasing intraoperative and     postoperative complications.      Methods The investigators plan to randomize about 150 women undergoing primary and repeat     cesarean deliveries to intra-abdominal chloroprocaine versus placebo prior to abdominal     closure. Women will be excluded if they have ascertained or presumptive hypersensitivity to     the ester type and major anesthetics; if they have chronic pelvic pain or if they refuse to     participate in the study. The investigators' primary outcome measure will be postoperative     pain as measured by visual analogue scale (VAS) at 1 hour after skin closure. Secondary     outcomes will include objective pain as measured by VAS at 2, 6, 24 and 48 hours at rest and     during mobilization, adverse effects of chloroprocaine (gastrointestinal side effects,     pruritus), concomitant analgesic requirement, hospital readmissions and length of hospital     stay. Analysis will follow the intention-to-treat principle.      The investigators will also be studying the concentration/effect (PKPD) relationship of     chloroprocaine use for pain control in the postpartum period. The time courses of the plasma     concentrations of chloroprocaine will be analyzed with mixed effects     pharmacokinetic-pharmacodynamic (PKPD).   "
1906|NCT03260959|"     Experience of the father following the announcement of a first pregnancy Its context,     immediate reactions and actions. Possible impact of this moment of life a few months or years     later?   "
1907|NCT03260946|"     Palliative care centres in Lyon, France as well as the disclosure of Complementary and     Alternative Medicine and conventional healthcare use to conventional and Complementary and     Alternative Medicine practitioners respectively.      These aims will be achieved through the following objectives:        1. Describe the prevalence of Complementary and Alternative Medicine practitioner and          product use in the outpatient population of palliative care centres in Lyon, France        2. Describe the characteristics of Complementary and Alternative Medicine users the          outpatient population of palliative care centres in Lyon, France        3. Estimate the Complementary and Alternative Medicine expenditure of the outpatient          population of palliative care centres in Lyon, France        4. Describe the rates of disclosure of both Complementary and Alternative Medicine and          conventional health care to health professionals by the outpatient population of          palliative care centres in Lyon, France        5. Describe the reasons for disclosure or non-disclosure of both Complementary and          Alternative Medicine and conventional health care to health professionals by the          outpatient population of palliative care centres in Lyon, France   "
1908|NCT03260933|"     This is a qualitative interview study investigating patients', carers' and providers'     perspectives on integrated care and integrated care pathways for frail older people in     Lambeth and Southwark, south London.   "
1953|NCT03260348|"     The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology     and long-term outcomes of the patients will be recorded.   "
2201|NCT03257072|"     Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus     larvae for a maximum of three times.   "
1912|NCT03260881|"     Epicardial adipose tissue (EAT) is the visceral fat of the heart. EAT could locally affect     the coronary arteries through local secretion of pro-inflammatory cytokines. EAT plays a role     in the development of the coronary artery disease (CAD). EAT is a highly enriched with genes     involved in inflammation. Given its rapid metabolism and simple measurability, as first     developed by Iacobellis, EAT serves as target for medications targeting the fat.     Glucagon-like peptide-1 agonists (GLP-1A) are anti-diabetic medications with recently     suggested cardio-protective properties. Liraglutide, a GLP-1A, has recently shown to reduce     the cardiovascular risk. Iacobellis'group found that EAT thickness decreased by an     unprecedented 36% after 12 weeks of treatment with liraglutide. Remarkably, Iacobellis'group     found for the first time that human EAT express GLP-1 Receptor (GLP-1R). GLP-1A effects may     be therefore visceral fat specific and target EAT. Based on these preliminary data, we     hypothesize that treatment with liraglutide will significantly and rapidly reduce EAT     inflammation. Decreased EAT inflammation can reduce the burden of the coronary plaques. We     will test our hypothesis in a 12-week randomized, double-blind, placebo-controlled,     interventional study in 40 patients with type 2 diabetes mellitus (T2DM), and CAD, with an     acceptable glycemic control on their current diabetes regimen who require elective coronary     artery bypass graft (CABG) regardless of their participation in the study. Inclusion criteria     for body fat markers will rule out the confounding effect of different body fast distribution     at baseline. Interim fructosamine test will insure glycemic equipoise between study arms.     Study subjects will be randomized in two groups of 20 patients to receive additional     liraglutide or to remain on current treatment/ placebo prior to cardiac surgery. CAD subjects     not allocated to liraglutide will be started on a supervised low calorie diet (LCD) to     achieve approximately 5% of weight loss after 12 weeks to avoid the confounding effect of     weight loss on the study outcomes. EAT samples will be collected during cardiac surgery and     processed for analysis of mRNA and protein expression of EAT inflammatory genes such as Tumor     Necrosis Factor-alpha (TNF-α) and Interleukin 6 (IL-6), and GLP-1R.   "
1913|NCT03260868|"     Primary Objective:      To evaluate the effect of virtual approach via novel technologies versus traditional study     conduct on glycemic control in terms of glycated hemoglobin A1c (HbA1c).      Secondary Objective:      To evaluate the appropriate utilization of virtual approach via novel technologies during the     study and to assess the effect of the virtual versus traditional study conduct on multiple     outcomes in terms of study methodology and diabetes management.   "
1914|NCT03260855|"     Cancer survivorship has become an important aspect of oncology research due to the risk of     physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim     of this research is to measure frequency and intensity of one of these issues: the fear of     cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0.   "
1915|NCT03260842|"     Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2)     patients at high risk, defined by family history and/or genetic mutations, for pancreatic     cancer.   "
1916|NCT03260829|"     efficacy of the injectable vitamin C to reduce the time of canine traction   "
1917|NCT03260816|"     The Advancing Child Competencies by Extending Supported Services (ACCESS) for Families     Program is a study funded by the National Institutes of Health to explore behavior and     developmental problems among young children aging out of Early Steps (Part C). All families     will participate in five evaluations in their home to learn more about their child's behavior     and development. Families also may receive treatment designed to help change their child's     behaviors that will be conducted over the Internet using a tablet.   "
1918|NCT03260803|"     Osteoporosis fractures impose a significant economic burden on the health system. There is     evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women),     and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the     prevention of osteopenia progression towards osteoporosis has been considered as an important     issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the     equilibrium between bone formation and resorption done by simultaneously regulating     osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption     contributes to reducing bone mineral density and hence increasing the risk of osteoporosis      Recently, new therapies have been focused on use of medicinal herbs, especially     phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act     both on osteoblast and on osteoclast.      Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant     and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in     vitro studies and animal models. Investigators aimed to investigate the effects of oligopin     on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in     postmenopausal women with osteopenia in a double-blind randomized clinical trial.     Participants are forty four women with osteopenia divided into two groups randomly (22,     having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia)     receives the same amount of the placebo. At the first and the end of the study, blood sample     are taken to measure in order to peripheral blood mononuclear cells isolation and plasma     separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in     plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and     protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in     peripheral blood mononuclear cells by measurement of expression and activity of magnesium     superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.   "
1919|NCT03260790|"     Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine     if they are given Prevnar initially.   "
1920|NCT03260777|"     Alopecia is a common, distressing condition that is sometimes difficult to diagnose and     treat.      Losing hair is not usually health threatening; it can scar a young child's vulnerable     self-esteem by causing immense psychological and emotional stress, not only to the patient,     but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed     and treated early to overcome the resulting problems.   "
1921|NCT03260764|"     In this study, the investigators provide participants who had congenital cataract the     multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way     to make a definite diagnosis with high efficiency and accuracy, and report a prospective,     randomized controlled study aiming at comparison of multifocal contact lenses and bifocal     spectacles.   "
1922|NCT03260751|"     This study was conducted to investigate the effects of daily supplementation of Zingiber     officinale Roscoe extract on body fat.   "
1923|NCT03260738|"     The objective of KERAAL technological project is to create a new intelligent robot which     allows a humanoid robot to record then to show and to follow the progress of rehabilitation     session proposed by a physiotherapist to a patient, the latter being able to practice without     the physiotherapist. The final objective is to stimulate and increase the overseen time of     rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements notably     movements of the spine with 5 degrees of freedom associated to the several levels of the     spine. It will allow to address the population included in the protocol. RCOOL study tries to     validate this prototype device as tool of rehabilitation.      The main objective is the feasibility of the supervision by a humanoid robot of a succession     of rehabilitation exercises.      RCOOL study is about a randomized clinical trial checked under single-blind condition to     compare two rehabilitation strategies, one with kinesitherapy exercises supervised by Poppy     and the other one with classic rehabilitation.   "
31796|NCT02869555|"     Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma   "
1925|NCT03260712|"     This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients.     The main objective is to detect an increase in progression-free survival rate at 6 months     (according to RECIST version 1.1) from 60% in patients with BTC treated with standard     chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.      Secondary objectives are:        -  Assess the treatment efficacy in terms of overall survival, immune related          progression-free survival, response rate (according to RECIST version 1.1), safety,          symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21)        -  Exploratory objectives include assessment of immunological response (cytokines,          lymphocyte phenotype, immunoglobulins), and evaluation of pathological and clinical          predictive factors for response/toxicity        -  Translational research will focus on biomarkers for prediction of response and toxicity.   "
1926|NCT03260699|"     While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms     of function and strength, whether these unloader braces are also similarly beneficial after     total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators     questioned whether wearing a brace that has previously been shown to increase strength and     function in OA patients can also increase strength and function in patients after TKA.   "
1927|NCT03260686|"     People who have had a stroke benefit from opportunities to practice the activities they need     to re-learn. It is common practice to give patients written exercises to guide their practice     out of therapy session. Whilst more practice is better, it is important that the activities     are practiced accurately, to ensure that the right movement patterns are re-learned.      The aim of this study, is to evaluate whether an intervention providing in-patients who have     had a stroke an opportunity to use a simple video guide to help them perform their exercises     accurately would improve clinical outcomes. Watching an activity being performed helps you to     learn the activity more effectively. The focus of this study is arm rehabilitation.      The participants will be adult in-patients in Leeds Teaching Hospitals Trust, and will have     had a first time stroke that has left them with some arm weakness.      The participants will be matched according to the severity of their weakness, then randomly     allocated to either a treatment as usual group, or an intervention group. Those in the     intervention group will have their exercises for their arm and hand recorded onto a tablet     during their normal therapy session. They will then be lent the tablet for the duration of     the trial, so they can have a visual guide to help them throughout the trial period. Ward     staff will be shown how to use the tablet to help any participants who struggle with the     technology.      Measurements will be made before and after the trial period to look at ability to move the     arm and hand, quality of movement, self-efficacy and time spent exercising. Participants and     staff will be asked for their experiences of the intervention or normal practice.      This is a feasibility study with an embedded process evaluation.   "
1928|NCT03260673|"     This study investigate the change of the corneal endothelial cells in patients with type 2     diabetes after phacoemulsification with intraocular lens implantation.   "
1929|NCT03260660|"     In this research study, the investigators will compare the liver stiffness results obtained     from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained     from a method that uses faster imaging techniques.   "
1930|NCT03260647|"     Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological     Cancers   "
1931|NCT03260634|"     Invasive fungal infections are a significant cause of morbidity and mortality in     immunocompromised host such as prolong neutropenic patients , post transplantation patients,     malignancies or advanced AIDS . The majority of these infections were caused by Aspergillus     species, which the first line of treatment is antifungal agent, Voriconazole , a triazole     antifungal drug which was approved by the Food and Drug Administration in May 2002 for the     treatment of invasive aspergillosis and refractory infections of Scedosporium apiospermum and     Fusarium spp. There are two forms of Voriconazole , oral and intravenous form. The     recommendation dose is 6 mg/kg twice daily for two dosages, followed by 4 mg/kg twice daily     in intravenous form or a loading dose of 400 mg twice daily for two doses is used (for     individuals >40 kg), followed by 200 mg twice daily, and in individuals <40 kg the     maintenance dose is 100 mg twice daily in oral form.      Voriconazole has a narrow therapeutic window and nonlinear pharmacokinetic profile with wide     inter-individual and intra-individual variability, such as age, race, genotypic variation,     liver dysfunction, the presence of food and drug-drug interactions with CYP450 inhibitors.     These large variations in pharmacokinetics may be associated with decreased efficacy or     increased toxicity. Therefore , monitoring of serum trough concentrations is recommended in     the following infections: invasive aspergillosis treatment , endophthalmitis; meningitis or     osteoarticular infections due to Exserohilum rostratum.      In Thai population , there are different genetic polymorphism from Caucasian ,resulting in a     different response to the initial dose and there is limited resources in Thailand , mostly     patients are unaccessible for Voriconazole level. Especially,in the period of starting drug,     which is the critical period for patients ,most of them are post chemotherapy which may have     gastrointestinal problems, mucositis , vomiting or diarrhea ,as well as receiving multiple     concurrent medications. All of these affect drug absorption,drug level and efficacy of     treatment. Thus, this study was designed to evaluated Voriconazole level in Thai patients in     the first two week after administration.      Primary question        -  From the first collected of Voriconazole drug level , Are the invasive fungal infection          patients in King Chulalongkorn Memorial Hospital achieved the drug level more than 60% ?      Secondary question        -  Which factor affecting Voriconazole through level in the first two weeks after          administration?      Research Design        -  Observational Studies (Descriptive retrospective and prospective study)      Research Methodology      Target Population        -  Patients received Voriconazole for treatment or prophylaxis invasive fungal infection      Study population        -  Patients in King Chulalongkorn Memorial hospital received Voriconazole for treatment or          prophylaxis invasive fungal infection      Sample size      n= ZZ/2P(1-P) /dd        -  n = sample size        -  P =Incident rate        -  From the pilot study of 15 Invasive fungal infection patients in King Chulalongkorn          memorial hospital from February to September 2015 , 60% ( 9 of 15 patients) of the first          collected of Voriconazole trough level achieved the therapeutic level.      replaced P = 0.6        -  Z = 95% confident interval = 1.96        -  d = acceptable error = 0.10      n = (1.96) (1.96) (0.60)(1-0.60) / (0.10)(0.10)      n =92 , sample size = 92      Study processing and data collection      Data collection        -  Collected data of patients received Voriconazole in first two weeks of treatment or          prophylaxis invasive fungal infection in King Chulalongkorn Memorial hospital in          2015-2017 from outpatient records , inpatient records and computer database in King          Chulalongkorn Memorial hospital. This data included        -  Baseline characteristics : sex, age ,weight ,BMI ,co-morbid ,personal history of smoking          or alcohol drinking        -  Basic laboratory investigation : complete blood count , Creatinin , liver function test          , albumin level        -  Gastrointestinal problems        -  Indication of Voriconazole treatment        -  Data of invasive fungal infection :        -  Data of Voriconazole usage : Loading dose, Maintenance dose, Trough level , Data of drug          adjustment, Concurrent medication used, Side effect        -  All data was summarized and recorded in case report forms.      Data Analysis and Statistics      The data was analysed by computer using SPSS17 program This study used descriptive statistics     ,describing general information, age, results, laboratory results and side effects of the     drug in mean ,percentage or standard deviation. And used the chi-square test for analysis of     the proportion of patients with serum drug levels within the therapeutic range.      This study used a confidence level of 95%, p-value less than 0.05 was statistically     significant.   "
1932|NCT03260621|"     Patients of the University Hospital Göttingen with echocardiographic signs for diastolic     heart failure and indication for right heart catheterisation will undergo additional     diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic     dysfunction and tissue characterisation correlating the results with well-established     clinical standards.   "
1933|NCT03260608|"     Dementias are neurodegenerative syndromes typical of the elderly population and causing a     high degree of disability and sick of dependence on others for care. Caregivers of patients     with dementia, especially those belonging to the same family suffer with high overhead and is     often affected by losses in their own health. The aim of this study is to evaluate the     efficacy of a psychoeducation and protocol support, conducted by telephone, in aid of     patients with dementia caregivers in specialized outpatient treatment. It will be selected     patients in outpatient specialized care. The primary outcome is the change in Zarit Scale.   "
1935|NCT03260582|"     The study will assess the efficacy of a web-based application as a complement to traditional     exercise-based cardiac rehabilitation for improvement of secondary prevention outcomes in     post-myocardial infarction patients, compared with usual care. The hypothesis is that the     intervention enhances patient adherence to lifestyle advice (exercise training, daily     physical activity, healthy diet and tobacco abstinence) and medication, resulting in better     risk factor control and prognosis as well as increased self-rated health.   "
1936|NCT03260569|"     This study will evaluate the changes in respiratory mechanics following traumatic brain     injury and determine the effect of inhaled nitric oxide on gas exchange.   "
1937|NCT03260556|"     Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis   "
1938|NCT03260543|"     This study was conducted to investigate the effects of daily supplementation of fermented     ginseng powder on improvement of Liver function.   "
1957|NCT03260296|"     Smartphones have become a part of our daily life, the number of people using smartphones is     increasing day after day. Easy access to internet is the main advantage of smartphones in     comparison to traditional mobile phones, so they are considered as handheld convenient     substitutes to computers. People use smartphones for many different purposes such as     communication, entertainment, browsing for information, education or business facilitation.     Unfortunately the excessive use of smartphones makes people 'addicted' to that type of     technology. Past research has shown that older people have less positive attitudes towards a     variety of technologies and they are less likely than younger people to embrace new     technology, so It seems that the problem of smartphones addiction is most likely to affect     young people who are fascinated with new technologies.   "
1958|NCT03260283|"     The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of     pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is     nowadays the common practice.   "
35319|NCT02823496|"     To evaluate the potential of a test material to produce a photoallergic response.   "
1939|NCT03260530|"     It appears necessary to confront the reality of the contribution of technological progress in     the creation of prostheses with the specific features of lower limb amputees. These     contributions must be clearly identified in their different functional dimensions. This     justifies a quantitative approach to the locomotor abilities of these patients, with regard     to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical     parameters (quantified analysis of movement), so as to measure the real impact of the     proposed prosthesis technology, as a complement to classical qualitative approaches.      In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC     1432), and the company PROTEOR established a research partnership aiming to:        -  Refine the indications for the prescription of new products, by ensuring that they          correspond to the profiles of the patients concerned and their true needs,        -  Study the underlying adaptive mechanisms, and establish new recommendations for their          use, depending on the profiles of the users,        -  And ultimately, better evaluate, in a more rigorous and systematic manner, the          prostheses available on the market.      The research protocol presented in this document aims to provide a framework for part of the     explorations that will be conducted in the context of this partnership. Lower-limb amputees     who will be evaluated in this research will wear these prostheses (foot and/or knee     prostheses), which bear the CE logo, and thus present all of the safety and performance     conditions required for their use by these patients (prostheses destined for usual     prescriptions), the objective of the study was not to evaluate the prostheses as such, but to     explore and quantify the impact of these prostheses and their eventual modifications on the     locomotor abilities of the patients concerned.      The investigations will be conducted using non-invasive evaluation tools available on the PIT     platform, with no modification in the usual management of these voluntary patients.   "
1940|NCT03260517|"     To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon     Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis     with coronary lesions previously treated with drug-eluting or bare metal stents in native     coronary arteries.   "
1941|NCT03260504|"     This phase I trial studies the side effects and best dose of aldesleukin when given together     with pembrolizumab in treating patients with kidney cancer that has spread to other parts of     the body. Aldesleukin may stimulate white blood cells to kill kidney cancer cells. Monoclonal     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and     spread. Giving aldesleukin and pembrolizumab may work better in treating patients with kidney     cancer.   "
1942|NCT03260491|"     This study has two parts: dose escalation and dose expansion.      The primary objectives are:        -  For Dose Escalation, to assess the safety and tolerability of U3-1402 in the study          population and to determine the recommended dose for expansion of U3-1402 in the study          population        -  For Dose Expansion, to assess the safety and tolerability of U3-1402 in the study          population      The number of treatment cycles is not fixed in this study. Participants will continue study     treatment for 36 months unless they decide not to (withdraw consent), their disease gets     worse [progressive disease (PD)], or side effects become unacceptable (unacceptable toxicity)     or other stopping reasons have been met.   "
1943|NCT03260478|"     Most trauma deaths are related to traumatic brain injury (TBI). Although the management of     patients has improved, mortality remains unacceptably high, and half of survivors of moderate     and severe TBI are left with major functional impairment. Current management guidelines are     based on limited evidence and practice is highly variable. Most acutely ill patients with TBI     will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical     practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed     concerns regarding restrictive strategies, which may adversely affect clinical outcomes in     TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion     thresholds on neurological functional outcome. We hypothesize that a liberal transfusion     strategy improves outcomes compared to a restrictive strategy.   "
1944|NCT03260465|"     This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in     combination with the optimys short stem. Wear rate and migration is assessed with roentgen     stereophotogrammetric analysis (RSA) measurements.   "
1945|NCT03260452|"     Based on solid preclinical results in mice and preliminary data in humans, this study aims to     provide the proof of concept of the crucial role of the hematopoietic process occurring in     human adipose tissue in the initiation of the inflammatory process at the origin of insulin     resistance and type 2 diabetes (T2D). The main objective is to compare the number of     pro-inflammatory macrophages derived from human adipose tissue hematopoietic stem cells (HSC)     according to their origin, type 2 diabetes subjects or healthy volunteers.   "
1946|NCT03260439|"     After the consent of the local ethics committee and informed consent of the parents, we     conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December     2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We     collected 53 children in each group.   "
1948|NCT03260413|"     This study aims to answer the question of what is the burden of lower respiratory disease     (pneumonia) among children ages 1 month to 5 years of age in rural Cambodia. The primary     objective will be to quantify the prevalence of severe pneumonia at Chenla Children's     Healthcare, a hospital in the rural town of Kratie, Cambodia. This will involve a chart     review of the medical records available at Chenla Children's Healthcare.   "
1949|NCT03260400|"     The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for     use in upper-limb amputation patients who have received the regenerative peripheral nerve     interface surgical procedure, in order to enable the use of advanced prosthetic arms and     hands.   "
1950|NCT03260387|"     Multi-center, prospective, observational cohort study of patients undergoing total     pancreatectomy with islet autotransplantation (TPIAT)   "
1951|NCT03260374|"     One of the main factors affecting the ability to maximize the full potential of a cochlear     implant is an accurate map.The goal of mapping is to enable cochlear implant recipients to     perceive a desired range of acoustic signals. The process includes programming of the minimum     and the maximum stimulation levels that are based on subjective measurements of thresholds     and the most comfortable level . The use of objective measures in the CI process has greatly     contributed to the definition of the dynamic field, as they provide specific values that     serve as the basis for the start of the mapping process, especially in cases of infants and     young children. Some examples of these measures are electrically evoked stapedius reflex     threshold , neural response telemetry , brainstem auditory evoked potential , and P300, among     others.   "
1952|NCT03260361|"     Relation between hypnosis and MEOPA on algodystrophy.   "
1959|NCT03260270|"     Venous thromboembolism (VTE) is a serious preventable complication of gynecological surgery.     High incidence of silent VTE before surgery seems attributable to the high incidence of VTE     after surgery in ovarian cancer .so the aim of work is to detect silent venous thrombosis in     gynecological patients suffering from pelvic masses using different imaging modalities .   "
1960|NCT03260257|"     Schizophrenia affects 2.4 million Americans and causes significant individual and societal     costs. Cognitive deficits including poor working memory arise early in the course of illness,     account for poor long-term outcomes and have been difficult to treat with available     treatments. The investigators are proposing to develop a novel, computer-based brain training     to improve working memory in schizophrenia patients, which, if successful could have     significant personal, societal, and economic impact.   "
1961|NCT03260244|"     This document is a clinical investigation plan (CIP) for the EnSite Precision Observational     Study.      This clinical study is intended to quantify and characterize the usage of the EnSite     Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world     environment. This study will be conducted in patients who are indicated for a cardiac     electrophysiological (EP) mapping and radio frequency ablation procedure using a     three-dimensional system.   "
1962|NCT03260231|"     Recent literature data suggest beneficial effects of dietary fats in patients with cancers,     in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin     seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.   "
1965|NCT03260192|"     Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to     evaluate patients' response to neoadjuvant chemotherapy   "
1966|NCT03260179|"     This project intends to make a study of personalized medicine evaluation system establishment     for liver cancer, gastric cancer and nasopharynx cancer to provide strong support for the     development of Precision Medicine and personalized medicine for the patients of     high-incidence-rates cancer in China.   "
1967|NCT03260166|"     This clinical study will test the efficacy and safety of nicotinamide for lupus-associated     skin lesions refractory to the treatment of hydroxychloroquine plus low-dose corticosteroids     in patients with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE).   "
1968|NCT03260153|"     The purpose of this study is to investigate the efficacy and safety of Deproteinised Calf     Blood Serum Injection in alleviating perihematomal edema (PHE) and secondary brain injury, as     well as neurologic deficits in patients with acute intracerebral hemorrhage (ICH).   "
1969|NCT03260140|"     More than a third of US Veterans who receive care through the VHA are obese, putting them at     higher risk for multiple serious chronic health conditions. Developing evidence-based     programs that are scalable, cost-efficient and serve a diverse Veteran population is a     priority for the VA National Center for Health Promotion and Disease Prevention (NCP). While     the VA's MOVE! program is an effective lifestyle intervention for obesity, its reach had been     limited. Some Veterans may best achieve weight loss with in-person group visits or by     internet and mobile technology-intensive programs, while others with a population-based,     self-directed program that uses minimal technology. This trial will examine the effectiveness     of a 12-month self-directed, low technology, and low resource lifestyle program. The program     uses a series of DVD sessions focused on healthy eating and physical activity, and encourages     participants to monitor their weight, diet, and physical activity for 24-months. For those     who want to, participants will be able to work with a lifestyle coach to help meet weight and     activity goals. The investigators hope the program will lead to modest, clinically meaningful     weight loss and increased physical activity among obese Veterans. If successful, this trial     may help ease the burden that obesity places on Veterans and the health care system.   "
1970|NCT03260127|"     This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress     disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD     has been associated with thinking problems, including difficulty planning/organizing,     thinking flexibly, and inhibiting distracting emotional information. There is some evidence     that computerized training programs are helpful for improving thinking. Therefore, this study     tests whether computerized cognitive training will in fact improve individuals' thinking     abilities and if this will in turn improve PTSD treatment outcomes and lead to more     individuals completing treatment and showing greater improvements in emotional symptoms and     quality of life than standard therapy (when paired with a word training condition).   "
1971|NCT03260114|"     Physical activity is one of the key strategies used by public health agencies to combat the     growing burden of obesity and non-communicable diseases. Adults around the world are     recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity     activity per week, or a combination of moderate or vigorous activity that results in     approximately the same total energy expenditure. However, majority of the population does not     meet the physical activity recommendation. As barriers to physical activity, people mostly     cite lack of time, self-motivation and confidence in the ability to be physically active.     Cardiac Exercise Research Group (CERG) at Faculty of Medicine and Health Sciences at     Norwegian University of Science and Technology recently developed Personal Activity     Intelligence (PAI). PAI is a result of research based on the HUNT study where more than 60     000 individuals has been monitored over a period of more than 20 years. The goal is to make     PAI the new world standard of activity tracking. PAI is an individual metric that makes sense     of measured heart rate data, and significantly reduces the risk of lifestyle related     diseases.      The purpose of the study is to obtain new knowledge about how the use of PAI is related to     body weight.   "
1972|NCT03260101|"     This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in     study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to     participate in this follow-up study.      Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up     study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post     transplantation, and will undergo the following evaluations: acute and chronic graft versus     host disease (GvHD) assessments, survival status (overall, relapse-free), disease status     (disease relapse/recurrence), physical examination, safety laboratory and concomitant     medication use.   "
1973|NCT03260088|"     Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs     and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized     countries. The cause of the pleural effusion remains unclear in a substantial percentage of     patients with persistently exudative effusions.   "
1974|NCT03260075|"     The aim of this study is to investigate the effect of ward cats in patient satisfaction by     patients and stations atmosphere in patients with substance abuse, depression and psychosis     and the employees working on these wards at UKP Basel.   "
1978|NCT03260023|"     The study will consist of two parts :      In the phase Ib part: safety will be assessed in consecutive cohorts of 3 to 6 patients at     increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will     be no intra-patient dose escalation.      In the phase II part, evaluation of efficacy and further evaluation of safety of the     combination of TG4001 and avelumab will be performed in a single arm cohort of patients with     HPV-16 positive oropharyngeal SCCHN.      In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.      All patients will be followed up until disease progression or death due to any cause or the     date of data cut-off, whichever occurs first.   "
1979|NCT03260010|"     The PROOF Study is an open prospective interventional non-randomized study which aim is to     determine the outcome / effect and safety of fosfomycin in patients with hip, knee or     shoulder PJI.   "
1980|NCT03259997|"     Efficacy of probiotics on physical performance   "
1981|NCT03259984|"     The investigators are trying to understand the role of DNA (deoxyribonucleic acid)     methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a     normal chemical process in the body that modifies DNA. By studying this, the investigators     hope to better understand the causes of insulin resistance.   "
1982|NCT03259971|"     Pediatric movement disorders comprise of a large number of different neurological diseases     including Rett syndrome (RTT) and Tourette syndrome. Studies in the literature as well as our     preliminary reports showed that Rett syndrome and Tourette syndrome/Tic disorders are     associated with a dysbiosis of the gut microbiota compared to normal control. Probiotic     Lactobacillus plantarum PS128 is a diet supplement that available for human consumption.     Probiotic Lactobacillus plantarum PS128 had showed psychotropic effects such as ameliorate     anxiety- and depression-like behaviors as well as altered the level of neurotransmitters such     as dopamine in the brain in animal models, which might be through microbiota-gut-brain axis.     Therefore, the purpose of this study is to access the possible neurobehavior effects of     Probiotic Lactobacillus plantarum PS128 in Rett syndrome and Tic disorders/Tourette syndrome.   "
1983|NCT03259958|"     A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg     Transdermal Delivery System (TDS) compared to daily oral administration of Aricept®   "
2012|NCT03259568|"     This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS)     on neural circuits as a function of spatiotemporal parameters and brain state in order to     better understand why the method works and how to improve its efficacy. Leveraging our     expertise in application of TMS methodology during concurrent single neuron recording     techniques in non-human primates and imaging and scalp potential techniques in humans (fMRI     and EEG), the investigators aim to resolve three interlocking problems in the design and     application of rTMS: stimulation frequency, spatial targeting, and interactions with brain     state.   "
2013|NCT03259555|"     To Demonstrate the Efficacy of Brexpiprazole for the Acute Treatment of Manic Episodes, With     or Without Mixed Features, in Subjects with a Diagnosis of Bipolar I Disorder   "
7269|NCT03190720|"     This study aims to investigate the effect of a mobile community based on a smart phone     application to enhance physical activities of breast cancer survivors.   "
1984|NCT03259945|"     The incidence of aortic valve disease is increasing steadily because of the ageing of the     population. At a certain stage, replacement of the aortic valve improves symptoms and thus     the quality of life of patients.      Surgical aortic valve replacement is the  gold standard . The procedure involves stopping     the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.      The reference technique consists in suturing a prosthetic valve to the aortic annulus so as     to restore normal function. This technique has very good results in the long term. The     elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of     infection, psychological trauma of a major incision. In recent years an alternative approach,     right minithoracotomy, has been proposed. The drawback to this approach is that it increases     aortic cross-clamp time and CPB time.      More recently, new prosthetic valves, so-called sutureless or rapid deployment valves     have become available. The main advantage of these valves is that they are easy to implant,     as they do not require or need just a few sutures. As a result heart-arrest time is shorter,     post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.      However, these valves have a metallic stent to fix the valve in place by pressing against the     aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few     studies have been conducted on this subject.      The investigators wish to evaluate these conduction disorders in a cohort of patients     operated on in this Department with this sutureless or rapid deployment valve technique.   "
1985|NCT03259932|"     After a minor stroke, patients frequently report complaints such as fatigue and difficulty     with certain everyday motor tasks, leading to a marked deterioration in their quality of     life. The aim of this study is to show that the implementation of a personalised physical     activity programme, starting 1 month after the hospitalisation for minor stroke,     significantly decreases the frequency of fatigue in these patients, in comparison with usual     management in real life..   "
1986|NCT03259919|"     To investigate the effect of metformin on pregnancy complications and pregnancy outcome in     the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.   "
1987|NCT03259906|"     For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite     the absence of consensus, in recent years, the use of open reduction associated with internal     plate fixation has considerably developed. Indeed, this therapeutic option allows a more     anatomical reduction and stable fixation.      First-generation posterior plates presented complications related to the size of the plate,     notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates     has reduced these complications.      In the literature, few studies have compared these two techniques in terms of functional and     radiological outcomes. The hypothesis of this research is that osteosynthesis using a     posterior plate is more effective than that with an anterior plate in terms of functional     recovery in patients older than 60 years.   "
2020|NCT03259464|"     The primary objective of this trial is to investigate the safety and tolerability of BI     685509 in healthy male subjects following oral administration of multiple rising doses.      Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics     (PD) of BI 685509 in healthy Chinese and Japanese subjects.   "
1988|NCT03259893|"     Atrial fibrillation (AF) is the most common arrhythmia affecting over 3 million Americans and     about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for     adults over age 40 years. AF is associated with a major medical and socioeconomic burden     including high cost, increased risk of stroke, heart failure, dementia, myocardial     infarction, and death. Numerous studies have demonstrated that modifiable risk factors     including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the     development of AF.      Recent studies have reported that secondary prevention interventions through aggressive risk     factor modification can reduce the burden of AF. Structured, physician and nursing-led     interdisciplinary AF programs have been shown to improve patient adherence to guideline     recommendations and improve long term prognosis. Previous data, however, are derived mainly     from white European and Australian cohorts and it is unclear whether such interventions can     be effectively implemented in a racially diverse, safety net hospital in the U.S.      This study is a randomized hybrid implementation-effectiveness study designed to investigate     feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk     factor modification and AF education in a racially mixed population receiving care in a     safety net hospital.   "
1989|NCT03259880|"     Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity     from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics     suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an     unfavourable disease progression and is associated with a poor prognosis.      The two most common and important causes of acute pancreatitis are gallstones (40-70%) and     alcohol (25-35%) Gallstone pancreatitis is usually due to an obstructing stone in the     pancreatic duct near the sphincter of Oddi . In alcohol-related pancreatitis, it is believed     that the acinar cells of the pancreas are susceptible to damage by ethanol and underlie the     etiology of the disease . Another common cause, iatrogenic pancreatitis, may occur after     endoscopic retrograde cholangiopancreatography (ERCP) in up to 5% of patients. Other     etiologies of acute pancreatitis include medications, infections, trauma, hereditary,     hypertriglyceridemia and autoimmune disease.   "
1990|NCT03259867|"     This is a single center, open-label phase IIA study that investigates the preliminary     efficacy of TATE treatment of liver cancer followed by a PD-1 checkpoint inhibitor (either     nivolumab or pembrolizumab). At least two cohorts will be enrolled, one for patients with     hepatocellular carcinoma (HCC) and the other with metastatic colorectal cancer (mCRC).   "
1991|NCT03259854|"     Conventional mechanical ventilation is a core feature of intensive care. Weaning and removal     of endotracheal tube are crucial processes, which often account for a considerable part of     Conventional mechanical ventilation total time. Unsuccessful extubation has been noted to be     associated with an increase of both morbidity and mortality in adult and pediatric patients   "
1992|NCT03259841|"     Investigators assess the gastric contents by ultrasonography in fasted patients undergoing     cholecystectomy.   "
1993|NCT03259828|"     Radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the     risk of recurrence. The radiotherapy plan must account for organ movement inside the body to     ascertain adequate dose is delivered to the target. Knowledge of the magnitude is crucial to     radiotherapy treatment planning. This study aims to quantify the movement of the sigmoid     colon between different fractions of radiotherapy treatment (interfraction motion) and within     the same fraction (intrafraction motion). This knowledge will help us determine the optimal     margin to use in radiotherapy treatment planning.   "
1994|NCT03259815|"     There has recently been renewed interest in the measurement of post percutaneous coronary     intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post     PCI FFR values ≥ 0.90 are associated with better clinical outcomes for patients but the     available data suggest that despite angiographically satisfactory results, this is actually     achieved in less than 40% of cases.      The main mechanisms for sub-optimal post PCI FFR measurements have been proposed to be stent     underexpansion, unmasking of a second lesion in the target vessel post PCI, residual diffuse     disease in the untreated segments and pressure drift (a technical artifact of pressure wire     technology).      Using post PCI FFR to guide stent optimisation and/or further intervention in the target     vessel has been shown to increase the frequency of achieving optimal post PCI FFR results     (and therefore presumably better clinical outcomes). However, there are additional costs     involved in the routine use of post PCI FFR and it is not clear just how often it is even     possible to increase the initial post PCI FFR to ≥ 0.90. This uncertainty means that it is     currently difficult to either recommend the routine use of post PCI FFR or justify its cost.      The investigators propose a prospective study to assess the feasibility of achieving post PCI     FFR ≥ 0.90 during standard PCI procedures in consecutive patients. The study would also     attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The     investigators anticipate using the data from this developmental study to support a subsequent     funding application for a definitive phase 3 study of the impact of FFR targeted PCI on     clinical outcomes.   "
1995|NCT03259789|"     The purpose of this study is to investigate the effect of bexagliflozin compared to placebo     as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with     type 2 diabetes mellitus (T2DM).   "
2017|NCT03259503|"     The goal of this clinical research study is to learn about the safety and effectiveness of     the combination of olaparib and high-dose chemotherapy (vorinostat, gemcitabine, busulfan,     and melphalan, either with or without rituximab) in patients who have non-Hodgkin's or     Hodgkin's lymphoma and are receiving an autologous stem cell transplant.      This is an investigational study. Olaparib is FDA approved and commercially available for the     treatment of ovarian cancer. Vorinostat is FDA approved and commercially available for the     treatment of lymphoma. Melphalan is FDA approved and commercially available for the treatment     of myeloma. Busulfan is FDA approved and commercially available for the treatment of     leukemia. Gemcitabine is FDA approved and commercially available for the treatment of     lymphoma, breast cancer, and lung cancer. Rituximab is FDA approved and commercially     available for the treatment of non-Hodgkin's lymphoma.      The use of these study drugs in combination to treat non-Hodgkin's or Hodgkin's lymphoma is     investigational. The study doctor can explain how the study drugs are designed to work.      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.   "
14275|NCT03098615|"     This study will examine how Jublia affects dermatophytomas, which are difficult to treat with     other therapeutic options.   "
1996|NCT03259776|"     Since 2011, people who have had a serious accident in England are no longer looked after at     the hospital nearest to them. Instead, they are cared for at a specialist hospital called the     regional major trauma centre. This is so that they can get the best possible care from     specialist professionals.      St George's is the regional major trauma centre for the 2.6 million people living in South     West London and Surrey County. This area stretches about 40 miles across.      About one fifth of major trauma patients who come to St George's live more than one hour's     journey away. Their visitors often travel a similar distance or even further. Family members     and friends play an important part during the patient's stay. It is important to support     visitors.      The aim of this study is to describe the experiences of visitors whose family member or     friend has been admitted to the major trauma intensive care unit at St George's. In     particular, the aim is to describe the experiences of visitors who travel from far.      First, ten visitors will be interviewed to find out more about their experiences. From these     data, a survey questionnaire will then be developed and approximately 150 visitors who have     been to St George's in recent months will be surveyed. This will give in-depth insights to     understanding peoples' experiences of visiting at St George's, and what people thought was     going well and things that could be better. The study will end with a service improvement     workshop with representatives from the team at St George's and visitors. Study findings will     be discussed and decisions on what should be improved will be made.      This study is being funded by St George's Hospital Charity. The study runs from August 2017     to October 2018.   "
1997|NCT03259763|"     Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is     associated with substantial morbidity. Palliation of GOO has traditionally been through the     surgical bypass of the obstructed lumen by creating an opening between the stomach and small     intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has     gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this     study, the investigators are going to compare the safety and efficacy of the two different     endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE)     and enteral stenting (ES).   "
1998|NCT03259750|"     Sport activity induces a relevant risk for lower extremities especially ankle and foot     structures. Athletes who participate in basketball, volleyball and soccer are predisposed.     Self-reported outcome instruments have been used by clinicians to assess the treatment     interventions effectiveness directed at patients with pathologies and identify impairments,     disabilities and quality of life. The assessment of musculoskeletal injuries can be problem     without clinical, radiological examination and on scores from patient-based questionnaires.     The information from these questionnaires provides us good evidence if there is not     interpretation of obtained scores. The Foot and Ankle Ability Measure (FAAM) is a     self-reported outcome instrument for patients with foot and ankle disorders available in     English, German, and French. The FAAM has a sports subscale and activity of daily living     (ADL) subscale that can assess the activities that requires higher level. The aim of this     study is to translate the FAAM into Turkish language, perform a cross-cultural adaptation,     and investigate the reliability, validity of the translated version in athletic population   "
2000|NCT03259724|"     Purpose of Study (The Effect of Non-Viscous Fibre Supplementation on Glycemic Control (NVFS &     GC) in Individuals with Diabetes Mellitus.      Regardless of the remarkable advancement in pharmacotherapy, diabetes mellitus remains a     major concern with more than 300 millions living with its complications including CVD.     Nutrition is a cornerstone in diabetes management, and increasing total dietary fibre have     been shown to decrease HbA1c, fasting glucose, fasting insulin, fructosamine, and HOMA-IR.     However, the main underlying mechanism is still not fully understood, and the specific type     and proportion of fibre supplementation to be recommended for such individuals is still     controversial.      Currently, the available findings/ results from small RCTs are inconsistent. The systematic     review method depends on combining data from many small studies in order a pooled estimate of     the pooled effect. The purpose of this study is to conduct a systematic review and     meta-analysis of randomized controlled trials (RCTs) assessing the effect of non-viscous     fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus.     We hope the findings of this study will play a role in developing the nutritional guidelines     for individuals with diabetes mellitus.   "
31797|NCT02869542|"     Database of Institut Paoli-Calmettes patients diagnosed with lymphoma   "
2002|NCT03259698|"     Despite decades of traditional prevention efforts based on behavior change and condom use,     Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure     prophylaxis (PEP) is one such approach, in which uninfected persons use 28 days of     antiretroviral medications (ARVs) shortly after an HIV exposure to minimize the risk of     acquiring HIV. PEP is highly efficacious, is considered a standard of care intervention based     on medical and ethical grounds, and is supported by treatment guidelines. Yet several     implementation challenges have limited its clinical and public health impact in Ontario,     where no formal PEP policy exists. Our proposal seeks to optimize two aspects of delivering     PEP for sexual exposures (nPEP). Results will inform the development of a standardized     approach to nPEP both province-wide and elsewhere.      Thus study has pragmatic, multicenter randomized controlled trial using a 2x2 factorial     design to determine whether the proportion of nPEP patients that successfully complete     follow-up:        1. is higher among those receiving mobile phone-based text messaging support than among          those receiving standard care; and        2. is non-inferior among those receiving care from a sexual health clinic nurse compared to          those receiving hospital-based physician care.      The prospective, randomized, non-blinded, 2x2 factorial trial that will enroll 358 study     participants in Toronto and Ottawa. In Intervention A, we will randomize half of study     participants to a text messaging support service ('WelTel'), in which a trained,     community-based research staff person provides standardized weekly 'check-in' messages during     their 12-week course of PEP follow-up. The other half will receive standard care, which does     not include any form of active outreach or reminders outside of scheduled appointments. In     Intervention B, we will randomize half of participants to receive nurse-led care for PEP     follow-up at a local sexual health clinic; the other half will receive standard care by a     hospital-based ID physician. The specific activities for each follow-up visit will be clearly     defined in a medical directive. In keeping with Ontario legislation on medical directives,     nurses will review cases with their authorizing physician or nurse practitioner on a routine     basis.   "
2018|NCT03259490|"     To establish the bioequivalence of one fixed dose combination (FDC) tablet of     empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of     empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single     dose under fed conditions   "
2019|NCT03259477|"     Renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC)     undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than     those with complete renal arterial clamping.   "
2021|NCT03259451|"     A retrospective, monocentric, observational, descriptive, open study of a cohort of 149     patients from January 2014 to December 2015   "
2003|NCT03259685|"     Increasing evidence suggest that artificial sweeteners such as saccharin, aspartame and     sucralose may not be as metabolically safe as they first appeared, and it has been proposed     that their consumption may be linked to important disturbances in the gut microbiome. Some in     vitro and in vivo studies suggest that the recently approved sugar substitute Stevia (eg.     steviol glycosides) can also influence intestinal homeostasis. However, it is not clear     whether this natural non-nutritive sweetener (NNS) could also cause metabolic and microbiome     disturbances as proposed for their synthetic counterparts. In fact, steviol glycosides may     even have a beneficial impact on glucose homeostasis and lipid metabolism possibly through a     positive action on intestinal health and gut microbiome, but this has yet to be     experimentally tested in a rigorous study.      The main objective of this project is to evaluate whether steviol glycosides sweetened     beverages (SGSB) or aspartame/acesulfame K sweetened beverages (AASB) exert beneficial,     neutral or detrimental effects on metabolic health of regular consumers of sugar-sweetened     beverages (SSBs), and whether modulation of the gut microbiome is involved in the resulting     impact of these NNSs on metabolic health.      As chronic overconsumption of SSBs is clearly associated with an increased cardiometabolic     risk, this study will be the first to determine the metabolic impact of replacing SSBs by     potentially healthier alternatives such as the increasingly popular stevia-based soft     drinks and aspartame-based soft drinks. The investigators will further investigate whether     these NNS can cause pernicious effects on intestinal health and the gut microbiome. It is a     crucial concern since the importance of this unsuspected key organ has been ignored for too     long and its important implication in many chronic societal diseases has just been     discovered.      Results of this study could have a direct influence on health, nutrition and even     agricultural policies as well as dietary guidelines around the world. This project is also     critically important as an increasing amount of health professionals such as physicians,     nurses and registered dietitians seek to provide evidenced-based guidance to individuals     looking for healthier alternatives to SSBs including stevia-based or aspartame-based soft     drinks.   "
2004|NCT03259672|"     This investigation is planned to compare the incidence and severity of postoperative sore     throat according to the use of sevoflurane or desflurane.   "
2005|NCT03259659|"     1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired          autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.        2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory          cytokines. Presence of these abnormalities would make patients with ulcerative proctitis          and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.   "
2006|NCT03259646|"     Violence against women is a major public health threat that carries significant consequences     for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual     assault (SA) are more likely than non-abused women to seek certain forms of health services,     such as for sexually transmitted infections, chronic pain and illnesses, depression and/or     pregnancy-related concerns. As a result, the health sector is an ideal setting to identify     and support survivors. The U.S. Institute of Medicine has identified the health care system,     including the public health infrastructure, as key for identification of and support for     survivors of violence, as well as for violence prevention. While some evidence-based models     exist, no current national consensus has been reached on scalable best practices in screening     and brief counseling for IPV/SA.      This multi-level intervention includes integrating into the clinic setting IPV/SA screening,     universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact     advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the     evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized     trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy,     health and safety outcomes, as well as participant and provider perceptions of the     intervention and clinic level changes in primary and reproductive health clinics in four     states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following     aims:      Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and     trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA     programs compared to standard practice, on survivor health and safety outcomes over a     cumulative period of six months.      Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma     informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA     programs and improved standards for documentation through the electronic health record (EHR)     and continuous quality measurement and reporting.   "
2007|NCT03259633|"     This will be an open-label, single-arm, multicenter intermediate access protocol which     provides treatment access to selumetinib for eligible patients with neurofibromatosis type 1     (NF1) who have inoperable, progressive/symptomatic plexiform neurofibromas (PN) without any     alternative therapeutic options. All patients will continue to receive drug while they are     deriving clinical benefit .      Approximately 50 patients in the US will be treated as part of this protocol   "
2008|NCT03259620|"     To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide     Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital     cutaneous common warts (verruca vulgaris).   "
2009|NCT03259607|"     This is a research study to verify the same effectiveness and safety profile for the test     products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products,     Nicorette Mint 2 mg gum and Nicorette Mint 4 mg gum (reference products), in a standardized     mode. This verification is done in a so-called bioequivalence study, which means that the     same amount of the same active substance (nicotine), in the same dosage form, for the same     route of administration, and meeting the same or comparable standards is performed.      During the study visits, blood samples will be drawn to measure the level of the substance in     the blood to verify that the two test products are comparable to the reference products.      Tolerability of the treatments will be evaluated based on reported and observed adverse     events.   "
2010|NCT03259594|"     Renal functional reserve may be improved in patients with simple renal cysts after     laparoscopic deroofing.   "
2011|NCT03259581|"     The aim of this study is to evaluate the safety of selective transarterial chemoembolization     (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but     relatively normal direct bilirubin.   "
31798|NCT02869529|"     Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia   "
2015|NCT03259529|"     Despite the current advances in clinical oncology, the prognosis of patients with resistant     diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore     there is a need for the introduction of novel treatment regimens. This phase I/II trial     evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and     rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety     of combination treatment will be evaluated with the determination of recommended dose     schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine,     gemcitabine, rituximab, and nivolumab.   "
2016|NCT03259516|"     There is evidence of involvement of checkpoint pathways, including PD-1, in the pathogenesis     and resistance of myelodysplastic syndrome (MDS). However monotherapy with checkpoint     inhibitors was ineffective in a number of studies, indicating the presence of several     mechanisms of resistance. This pilot study evaluates the safety and preliminary efficacy of     nivolumab combination with currently existing treatments in MDS patients who failed at least     one line of therapy. The study evaluates if there is a combination which induces objective     responses.   "
2038|NCT03259230|"     This observational study is designed to provide a better understanding of the potential use     of IFNγ and IFNγ-inducible chemokines as markers of HLH disease activity and prognosis, and     of the potential of IFNγ as a therapeutic target in M-HLH.   "
2022|NCT03259438|"     This parallel, randomized, non-inferiority trial will examine whether a ten week qigong     intervention is not inferior to a ten week exercise-nutrition comparison group in reducing     fatigue in cancer survivors. To build a more mechanistic understanding of physiological     changes associated with fatigue reduction, it will secondly collect several different types     of data to build an integrative brain-body model of vigor in cancer survivorship including:        1. data related to neural correlates of body awareness: cortical EEG data measuring each          subject's ability to use attention to control neurons in primary somatosensory cortex          (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures          of insular connectivity with nodes of the default mode network and salience network        2. data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6          and tnf-alpha)        3. data related to cardiorespiratory functioning including cardiac impedance (ICG) and          mechanical lung function        4. data related to parasympathetic and sympathetic signaling between the nervous system and          the rest of the periphery.   "
2023|NCT03259425|"     This is a single-arm, open label, Phase II study evaluating the safety and efficacy of     neoadjuvant Nivolumab and HF10 in resectable stage IIIB, IIIC, and IVM1a melanoma.   "
2024|NCT03259412|"     The aim of the study is to determine whether fish oil (specifically omega-3 long chain     polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance     exercise performance when combined with a resistance exercise training study. The     investigators aim to establish the potential mechanisms that might mediate performance     changes at a cellular level.   "
2025|NCT03259399|"     Dry cough is the most common adverse reaction of angiotensin converting enzyme, including     enalapril, in Chinese population. Clinical observations suggest that the incidence of     ACEI-induced dry cough is different between Chinese and other racial groups, however, there     is still lack of research data in Chinese. In this study, we will investigate whether there     are specific genotypes which may predict the incidence of enalapril-induced dry cough in     Chinese so as to provide a basis for developing guidelines on precise medication in enalapril     therapy apply to Chinese population.   "
2026|NCT03259386|"     The purpose of this study is to learn more information about nerves. This study is also     designed to learn how the information in nerves could be used to develop new prosthetic     devices.   "
2056|NCT03258996|"     The main objective is to assess whether the percentage of root coverage (%RC) achieved in the     treatment of multiples class III recessions using the technique we have called modified     vestibular incision subperiosteal tunnel access (mVISTA), which is a lateral approach     subperiosteal tunnel technique, combined with a connective tissue graft is greater than that     achieved through the coronally advance flap (CAF) technique together with a connective tissue     graft.   "
2164|NCT03257579|"     Quasi-experimental, controlled interrupted time series design, evaluating the impact of the     intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education     will be provided, St Joseph's Hospital (SJH) where education alone will be provided and     Niagara Health Services (NHS) sites where education and point of care reminders at discharge     to promote 90 day prescriptions and 3 repeats, with remaining Ontario cardiac sites as a     concurrent control group.   "
2027|NCT03259373|"     The purpose of this study is to use a decentralized claims database to determine whether     education on stroke prevention in atrial fibrillation (AF) among AF patients and their     providers can result in increased use of oral anticoagulants (OAC) for stroke prevention     among those AF patients with guideline-based indications for oral anticoagulation     (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a     prospective, randomized, open-label education intervention trial to evaluate the effect of     the early patient and provider education interventions on the proportion of patients with     evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4     international normalized ratio (INR) tests) over the course of the 12-months of follow-up. A     total of approximately 40,000 patients will be enrolled within multiple major health plans     across the United States. The randomization will be performed by the central coordinating     center, and the health plans will mail the educational intervention materials to their     members and providers.   "
2028|NCT03259360|"     The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial     (N=120) compared to TSP and two historical control conditions. Participants will be young     adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary     outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months.     Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco     abstinence at 3 and 6 mos.   "
2029|NCT03259347|"     The purpose of this study is to assess the effectiveness of two body acceptance programs for     women. Participants may experience reduction of eating pathology and prevention of future     obesity and eating disorders; may derive a sense of altruism and contribution to furthering     understanding of a public health problem.   "
2030|NCT03259334|"     The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based     on composite score of patient-reported symptoms and centrally read endoscopy, in subjects     with moderate to severe ulcerative colitis (UC).   "
2031|NCT03259321|"     The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2     diabetes (T2D) is heavily debated but evidence from large populations in China is scant. We     aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term     association between fish, PUFA intake and T2D risk.   "
2032|NCT03259308|"     The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based     on composite score of patient-reported symptoms and centrally read endoscopy, in subjects     with moderate to severe ulcerative colitis (UC).   "
2033|NCT03259295|"     The objective of this study is to assess the efficacy of using the Digiclamp device to remove     achrocordons (skin tags). The hypothesis is that utilizing the device will result in low     rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.   "
2034|NCT03259282|"     Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in     a retrospective cohort of patients at Rennes University Hospital   "
2039|NCT03259217|"     This study will assess the efficacy of application of stem cell in healing of chronic     diabetic foot ulcer   "
36875|NCT02803021|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
2040|NCT03259204|"     Lower limb immobilization is associated with high risk of complications, i.e. venous     thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized     patients, however, low- or non-effective and associated with adverse events. Thus, there is a     need for novel treatments.      This study aims to demonstrate in leg immobilized patients who have suffered an ankle     fracture (900 patients) or an Achilles tendon rupture (400 patients) that adjuvant     intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow,     compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.   "
2041|NCT03259191|"     Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux     disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.   "
2042|NCT03259178|"     Sports-related concussion affect 1.6 to 3.8 million people each year in the United States.     Despite increased media attention and awareness campaigns, the exact number is difficult to     determine due to underreporting by athletes. The types of symptoms experienced with a     concussion depend on the area of the brain that was affected. The most frequent symptoms     include: headaches, cognitive difficulties, dizziness, neck pain, visual disturbances,     difficulty sleeping, and fatigue.      Despite the availability of many treatment options, some patients continue to experience many     symptoms - such as headaches, dizziness, visual disturbances, balance problems, sensitivity     to light, and difficulties concentrating - that negatively affect school, work, and quality     of life for long periods of time. All of these symptoms are similarly experienced by     individuals with visual dysfunctions, such as the inability of the eyes to move together.     This finding has led some to recommend a visual component in concussion management.     Therefore, the purpose of this study is to determine whether changes in the results of 7     binocular vision tests (BVT) over time in patients with concussion correlate with changes in     concussion symptoms. The investigators will measure 46 concussion patients aged 18 to 30     years with each of these tests and assess their concussion symptoms on up to four separate     visits, which depend on when the patient's symptoms improve.      The tests the investigators will evaluate measure: 3D vision, uniform movement of the eyes,     ability of the eyes to adapt to a target moving towards and/or away from the eyes, quick     movements of the eyes, natural alignment of the eyes, and double vision as a target is moved     towards the eyes. In addition, concussion symptoms will be measured by a standardized     concussion questionnaire (SCAT3) at each visit.      The results of each BVT will be entered into a statistical model with the participant's     concussion symptom score to determine if there is an association between the change in     symptoms and the change in the results of the tests.   "
2110|NCT03258294|"     This clinical study is a double-blind, randomized, placebo-controlled trial to investigate     the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients,     symptoms which have a significant impact on the quality of life of these patients.   "
31799|NCT02869516|"     Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia   "
2043|NCT03259165|"     Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially     treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27%     of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies     have all failed. The evidence for existing AHF therapies are poor: No currently used AHF     treatment is known to improve outcomes. ED treatment is largely the same today as 40 years     ago. Congestion, such as difficulty breathing, weight gain, and leg swelling, is the primary     reason why patients present to the hospital for AHF. Treating congestion is the cornerstone     of AHF management. Yet half of all AHF patients leave the hospital inadequately decongested.      Although it is the investigators' belief patients are often inadequately decongested in the     ED, it is common teaching within emergency medicine to focus on vasodilators and avoid or     minimize diuretics, especially in those patients with elevated blood pressure. This practice     is largely driven by retrospective analyses or small studies suggesting vasodilators are     efficacious and IV loop diuretics may be associated with harm. The evidence base to guide     early ED management is poor, and the AHA/ACC guidelines provide little to no guidance for ED     treatment. This reflects the lack of high quality data, a critical unmet need that the     investigators will address in this study.      Using clearance of LUS B-lines as the study endpoint, the investigators will study whether a     diuretic intense vs. nitrate intense strategy achieves better decongestion. Although nearly     two decades old, a small study of 100 patients suggested a nitrate intense strategy led to     better outcomes in AHF patients with pulmonary edema when compared with a diuretic intense     strategy. The investigators aim to perform a small pilot study, in hypertensive patients (SBP     > 140mmHg) to test such a strategy to inform a larger, more definitive multicenter randomized     trial.   "
2044|NCT03259152|"     Giant cell tumor of bone (GCTb) is a primary, osteolytic, benign tumor of the bone. Surgery     is the commonly used treatment. Discovery of RANKL and its human monoclonal antibody,     denosumab, led to use of denosumab for treatment of GCT. The aim of this study was to     evaluate clinical and pathological results of treatment of relapsed or refractoriness GCT     with denosumab and to assess adverse effect profile and recurrence rate.   "
2045|NCT03259139|"     More American children die by accidental gun use than children in other developed countries.     One factor that can influence children's interest in guns is exposure to media containing     guns. The objective of this study is to test whether children who play a video game     containing guns will handle a real gun longer and will pull the trigger more times than     children who see the same movie without guns.   "
2046|NCT03259126|"     Radiation dose to interventional cardiologists performing transradial percutaneous coronary     procedures is higher compared to those performing transfemoral exams. The radiation dose     seems particularly high at pelvic level. We prepared an home-made protective extension of the     leaded curtain under table that should reduce the operator exposure during interventional     coronary procedures. The aim of the study is to evaluate the procedural efficacy of the     protective extension on the operator radiation dose at pelvic level   "
2047|NCT03259113|"     Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased     risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will     provide data on cardiac rhythm over a period of 18 months. This will provide an extended     monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care.     Therefore, detection of arrhythmias could be used in risk stratification and decision-making     with regard to offer an implantable defibrillator and anticoagulants.   "
2048|NCT03259100|"     The investigators evaluated the spatial association between, cardiovascular diseases (CVD)     and stroke mortality rate with average ambient temperature (Ta) , and then used this     relationship to model future temporal trends in mortality from CVD and stroke till the end of     century (2099) using different warming scenarios across the mainland USA.   "
2049|NCT03259087|"     The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between     participants with impaired renal function and healthy control participants, to investigate     the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the     safety and tolerability of MK-3866 in participants with impaired renal function.   "
2050|NCT03259074|"     The purpose of this study is to demonstrate the impact of secukinumab on progression of     structural damage in the spine, as measured by the mSASSS in patients with AS.   "
2051|NCT03259061|"     The aim of this work is to evaluate the role of cephalometry &nasofibroscopy as objective     tools in order to confirm the diagnosis based upon the clinical judgment of border line cases     suspected to have velopharyngeal incompetence or insufficiency.   "
2052|NCT03259048|"     Acute abdomen can be defined as A syndrome induced by wide variety of pathological     conditions that require emergent medical or more often surgical management [1].There are a     plethora of causes that can lead to acute abdomen in children, they vary depending on the     ages of the children and can be divided into diseases that can be treated with medical care     and those in which emergency surgical intervention must be considered [2]. Ultrasonography is     the initial choice in the diagnosis of the different causes of acute abdomen in children [3,     4]. It is very useful as it is non-invasive, cost- effective, repetitive, with no radiation     exposure, as good as laparoscopy, can be done even in patients with scarred abdomen [5].   "
2054|NCT03259022|"     Hypothesis:        1. Innate immunity is altered in certain patients with COPD and frequent exacerbations, a          fact that makes them more susceptible to being infected by bacteria.        2. The electronic nose is able to detect patterns of specific VOCs for exacerbations of          infectious origin.   "
2055|NCT03259009|"     Some data have suggested a clinical survival benefit related to the reintroduction of     anti-EGFRs therapy in patients with metastatic colorectal cancer (mCRC). Based on resistance     mechanisms related to the development of resistant clones, the investigators could assume     that patients who benefited most from the reintroduction of anti-EGFRs were those who,     through interval chemotherapy, had no longer mutated RAS clone in plasma that appeared during     the progression with the first anti-EGFR treatment. Conversely, those who did not benefit     from this therapy were probably patients who had mutated RAS clones circulating at the time     of reintroduction of anti-EGFRs. To support this hypothesis, investigators propose to     evaluate the correlation between the eventual presence of RAS mutations in circulating blood     and the efficacy of an anti-EGFR therapy reintroduction in patients with mCRC.   "
2111|NCT03258281|"     Pospective, single center, double-blind, randomised pharmacodynamic experimental study. The     study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and     Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible     patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2)     placebo.   "
2057|NCT03258983|"     Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may     reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial     infarction, ischemic stroke and peripheral artery disease. However, the results of previous     studies have been inconsistent.      Objectives: To investigate the associations between dietary intake of ALA, adipose tissue     content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident     myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.      Methods: This project will be based on data from the Danish cohort study Diet, Cancer and     Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary     intake of ALA will be assessed using a validated semiquantitative food-frequency     questionnaire and adipose tissue content will be determined with the use of gas     chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed     information on lifestyle factors, medical history and anthropometri was collected at     baseline.      Incident cases have been identified through national registries and the diagnoses have     previously been validated.      Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas     analyses on adipose tissue content of ALA will be analysed based on a case-cohort design.     Hazard ratioes with 95% confidence intervals will be used to describe the associations     between the exposure variables and the outcome variables of interest.   "
2058|NCT03258970|"     To assess the cross-sectional and 5-year prospective association between self-reported     vitamin C+E dietary supplementation and markers of grip strength and frailty in     community-dwelling Swiss adults.   "
2059|NCT03258957|"     Necrotizing enterocolitis (NEC) is a severe inflammatory disorder of the intestine that     primarily affects very low birth weight (<1,500 g)/very preterm infants (≤32 weeks'     gestation); it is also the leading cause of death in the neonatal intensive care unit     (NICU).Perhaps the best form of treatment for NEC is prevention. Mother's breast milk is best     for preventing NEC. Breast milk contains both nutritional components (proteins, amino acids,     fats, carbohydrates, vitamins, and minerals) and bioactive components (macrophages, T cells,     cytokines, hormones, and growth factors) that have antimicrobial and anti-inflammatory     properties.The current NICU breast milk feeding procedure exists as a means of ensuring that     infants have consistent access to their mother's breast milk even if the mother is not able     to spend time in the NICU. The process also allows for stricter quality and infection     control, as well as computerised inventory and monitoring via electronic health     records.However, the process deprives infants of the benefits of the cellular content of     breast milk, including the stem cells.The primary objective of this study isto evaluate the     feasibility and safety ofproviding very preterm infants (born at <30 weeks' gestation) with     fresh milk (within 4 hours of expression).While we acknowledge that as a pilot the study will     not be powered to detect a statistically significant difference, our secondary objective is     to identify if this approach has the potential to improve infant outcomes, particularly with     regards to the occurrence of NEC.      Our hypothesis is that it is feasible for many mothers to provide at least 1 feed of fresh     breast milk (<4 hours post expression per day, and is not frozen, chilled or pasteurized) and     that this may decrease the prevalence of NEC   "
2060|NCT03258944|"     In several diseases in which muscle weakness is a determining factor for morbidity and     mortality, inspiratory muscle training has been shown to be useful in improving the function     of ventilatory muscles, delaying or minimizing the development of complications due to the     reduction of inspiratory muscle strength.      The breath-stacking technique emerges as an easily applicable alternative, and it can be used     in poorly collaborative patients. The technique described in the literature aims to increase     pulmonary volumes.      This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional     valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this     medium, generating pulmonary hyperinflation and increasing the contractility power of the     expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the     peripheral air distribution in the lungs by increasing intrathoracic pressure.      The objective of this study is to evaluate the effect of the breath-stacking (BS) technique     on the ventilatory muscle strength of young and healthy individuals.   "
11484|NCT03135587|"     The aim of this study is to investigate the influence of increasing loading to kinematic     parameters of normal people while walking on the treadmill.   "
2061|NCT03258931|"     A phase III randomized multi-center study designed to compare the efficacy of crenolanib with     that of midostaurin when administered following induction chemotherapy, consolidation     chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3     mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib     in addition to standard first line treatment of AML (chemotherapy and if eligible,     transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible     subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3     mutation status is confirmed and additional eligibility is established, subject will be     randomized and enter into the treatment phase.   "
2062|NCT03258918|"     The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss     as well as the percentage of participants who achieve 5% weight loss in a 16-week,     Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP     cohort will be compared to weight loss outcomes from previously published DPP studies. The     investigators will also evaluate secondary outcomes including change in physical activity,     mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.   "
2063|NCT03258905|"     The goal of this project is to continue to develop a smartphone application (app) to help     youth from ages 18-25 who have a substance abuse problem. The app will engage them in     grounding, which is a sensory-based experience to help them feel calm by reducing intense     negative feelings and impulses (such as the urge to use a substance or hurt themselves or     others).   "
2064|NCT03258892|"     This randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in     improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The     Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more     engaged with care, encourage communication, and to better manage side effects associated with     chemotherapy treatments in order to improve quality of life.   "
2192|NCT03257202|"     This study is about preventing surgical site infections of the shoulder. We hope to learn if     clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can     affect growth of Propionibacterium acnes in the dermal layer.   "
2065|NCT03258879|"     Epidural, Combined Spinal-Epidural, and more recently dural puncture epidural are forms of     neuraxial anesthesia used to provide pain relief in laboring women . The investigators want     to assess the onset of pain relief with 2 different neuraxial techniques performed at our     center, but which have not yet been compared in the literature: (1) Modified CSE, with only     local anesthetic injected into the spinal fluid to reduce side effects of opioids that are     seen with the traditional CSE and (2) Dural Puncture Epidural (DPE), involving puncture of     the spinal membrane, but without injection of medication into the spinal space. The     investigators hypothesize that the onset of labor analgesia will be faster with modified CSE     compared to DPE.   "
2066|NCT03258866|"     The project was undertaking by Qilu Hospital of Shandong University in China. In order to     compare the efficacy, safety and response duration of different dose of rituximab in patients     primary immune thrombocytopenia(pITP).   "
2067|NCT03258853|"     The current study is designed to test the feasibility of the a wearable bionic pancreas     system that automatically delivers insulin and glucagon can provide superior regulation of     glycemia versus usual care for adults with cystic fibrosis related diabetes.   "
2068|NCT03258840|"     The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)     supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum     levels of some indicators of vascular inflammation, and the gene expression of PON2 in the     peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.   "
2069|NCT03258827|"     As the proportion of older adults increases, elderly-related issues attract more attention.     Sarcopenia is one of the popular elderly-related issues. Sarcopenia may induce decreased     muscle strength, poor physical activity, even disability and increase rate of hospitalization     and mortality. Therefore, we want to figure out the management for decreasing prevalence of     sarcopenia in older adults. This trial is planned to perform during 2017/08/01~2017/12/31. We     plan to enroll 60 elderlies who are sarcopenia. These patient will be divided into 2 group     randomize. Experimental group will be received a set of exercise, composed by warm-up,     strengthening training with a towel, cold-down, 60 minutes per time, 3 times per week.     Control group will be suggested home-based walking activity. We will evaluate the patient's     functional performance three times, before training, after training, post-training for three     months, respectively. These results will be analyzed by repeated measure ANOVA.   "
2070|NCT03258814|"     This study is a non-interventional, longitudinal and non-confirmatory study to compare an     active supervised training (AST) with standard of care (SOC) physiotherapy in patients with     axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to     health-related outcomes. The primary objective is the improvement in spinal mobility after a     6 month training program. SOC physiotherapy will be prescribed on physicians and performed on     physiotherapist's discretion. Further objectives are the improvement in physical function,     health-related quality of life, disease activity, pain, psychosocial risk factors and     workability.   "
2071|NCT03258801|"     The diagnosis of idiopathic pulmonary fibrosis (IPF) is currently one of the most common     diagnoses for patients under evaluation for lung transplantation. In recent years, an     absolute increase in prevalence/ incidence of IPF has been observed. There is evidence that     patients with IPF on waiting list for lung transplantation might benefit from pirfenidone     treatment. Until now, no data are published regarding this important issue in lung     transplantation.      Primary objective is to determine whether there is a difference in the duration time of     mechanical ventilation (weaning) directly after lung transplantation between patients treated     with pirfenidone and patients without pirfenidone treatment. The Secondary objectives are to     determine whether there are differences between the pirfenidone treatment group and the     control group regarding survival after LUTX, the score on the Saint Georges Respiratory     Questionnaire and the decline in forced vital capacity (FVC%) In this Investigator initiated,     non- interventional single center study , patients on the waiting list for transplant     pirfenidone treatment receive oral pirfenidone at the standard dose of 2403 mg per day. The     treatment duration will range from 6 to 12 months. A control group will be used to correlate     the outcome-parameters for a descriptive comparison. The control group includes patients with     IPF on the waiting list who were on another IPF specific (or no) treatment for IPF The Study     Population are Patients aged between 40-70 years who are admitted to the lung transplantation     department and fulfill the international criteria for idiopathic pulmonary fibrosis (     existence of a usual interstitial pneumonia (UIP) pattern in the high-resolution computed     tomography (HRCT) is necessary).      Variables: Duration of mechanical ventilation after LUTX (hours), Forced Vital capacity     relative to reference value at baseline (FVC0%), Forced Vital capacity relative to reference     value after 6 months (FVC6%),Forced Vital capacity relative to reference value after 12     months (FVC12%) Study Size: 30 patients in the Pirfenidone group, 20 patients in the control     group.      For the primary Endpoint, the mean, standard deviation, median, minimum and maximum of the     weaning time of patients who received a pirfenidone treatment, as well as of patients from     the control group will be computed and presented in a table. Additionally, a Kaplan-Meier     curve will be estimated and plotted alongside the respective 95% CI calculated using the     method of Brookmeyer and Crowley. Furthermore, a stepwise linear regression using forward     selection and Age, RBMI, FVC0%, (FVC6%-FVC0%), TLC, FEV1% and ECMO, as well as the     pirfenidone treatment as predictors will be computed. The null hypothesis is that the     pirfenidone treatment has no influence on the weaning time. The according model coefficient     estimate and standard error will be used to test the null hypothesis using a t-test at     significance level α=0.05.      For the secondary endpoints, the mean, standard deviation, median, minimum and maximum of     patients who received a pirfenidone treatment, as well as of patients from the control group     will be computed and presented in a tableStepwise Cox Regression using forward selection and     Age, RBMI, FVC0%, (FVC6%-FVC0%) and ECMO, as well as the pirfenidone treatment as predictors     will be computed in order to compare the treatment and the control group a . If p-values are     calculated for the secondary endpoint analysis, they serve only descriptive purposes.     Therefore no multiple testing corrections are applied.   "
2072|NCT03258788|"     Participants with Non-Small Cell Lung Cancer (NSCLC), Performance Status (PS) 0-2, not     suitable for concurrent Chemo-Radiotherapy (CTRT), will be treated with standard radiotherapy     (radical or palliative). Archival tumour biopsies will be analysed for baseline Programmed     Death Ligand 1 (PD-L1) expression. Some participants will have a biopsy before radiotherapy     if the archive biopsy is not suitable. Participants will be required to undergo an additional     mandatory post radiotherapy course biopsy of the irradiated site ideally during the last 7     days of radiotherapy or within 7 days of completing the course of radiotherapy.   "
2165|NCT03257566|"     Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is     suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset     and in yearly intervals after the age of 12 yr. Furthermore, the International Society for     Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of     thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of     diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more     frequent if goitre present .   "
2073|NCT03258775|"     A randomized, cross over study will assess the effects of ingestion of high and low volumes     of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water     250ml. Participants will be computer randomized to determine which volume of water to receive     first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and     7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any     food or drink after 10pm the night before the assessment. Participants will also be asked to     abstain from alcohol and caffeine for 3 days before the assessment. After verification of     eligibility, baseline REE will be measured for 30 minutes followed by administration of first     assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and     heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period,     participants will return for their second test day where the second dose of water will be     administered. A 7-10 day washout period was selected to allow participants time to resume     normal diet and hydration between visits.   "
2074|NCT03258762|"     Pyrimethamine in combination with a sulphonamide is known to be effective in the treatment of     toxoplasmosis. However, Pyrimethamine has not been approved by the Japanese regulatory body     (Pharmaceutical and Medical Devices Agency [PMDA]/ Ministry of Health, Labor and Welfare     [MHLW]). The pharmacokinetics (PK) of Pyrimethamine has been investigated following     administration of Sulfadoxine/Pyrimethamine tablet in healthy Japanese subjects. However, the     study did not provide sufficient information for approval of Pyrimethamine in Japan; hence,     PMDA has requested confirmation of the PK of Pyrimethamine in another PK study in Japanese     and Caucasian healthy subjects. This study will be a single centre, open-label,     parallel-group, single oral dose study to evaluate the PK, safety and tolerability of     Pyrimethamine in healthy Japanese and Caucasian male subjects. Subjects will undergo a     screening visit within 30 days prior to first dose of the study drug. On Day 1, subjects will     be administered a single oral dose of pyrimethamine 50 milligrams (mg) along with calcium     folinate 15 mg after an overnight fast of at least 10 hours. Subjects will continue to     receive calcium folinate once daily until Day 8 of the treatment period. Blood sampling for     PK analysis and safety assessments will be performed prior to dosing and over 22 days after     dosing. Each subject will participate in the study for approximately 2 months from screening     to follow-up.   "
2112|NCT03258268|"     A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic     outcomes of individualized treatment support in patients with type 2 diabetes. The primary     objective of the trial is to confirm the superiority of standard of care with EASY DSS versus     standard of care without EASY DSS in terms of glycemic control in patients with type 2     diabetes with ongoing treatment with any antidiabetic drug(s).   "
31800|NCT02869503|"     Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer   "
2075|NCT03258749|"     Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent     airflow limitation and associated with an accelerated decline in lung function, impaired     quality of life, hospitalization, and increased mortality. As a major public health problem,     COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus,     prevention of exacerbations is a important goal in the management of COPD. The Global     Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint     project in 1998. Its goals were to raise awareness of COPD and to improve prevention and     treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting     bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled     long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD     patients. However, it is not known whether LABA or LAMA will be more effective for initial     relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the     investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment     of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the     secondary endpoints include the frequency of COPD exacerbation, other lung function     parameters, CCQ score and mMRC/CAT score.   "
2076|NCT03258736|"     The caudal block is the most common technique for inguinal surgery. Increased use of     ultrasound in regional analgesia techniques has been improved the practise of the peripheral     nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative     methods to the central blocks. The aim of this study is to compare analgesic efficiency of     caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for     bilateral inguinal hernia in pediatric patients   "
2077|NCT03258723|"     Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk     pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.      Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle     intervention, with escalation to Metformin therapy will lower the incidence of diabetes among     the highest risk pre-diabetic individuals of Caribbean-descent.   "
2078|NCT03258710|"     Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus     (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in     subjects with chronic hepatitis B associated with HBV growth and abnormal liver function.     This study has been planned to evaluate the virological effects and safety of switching from     ETV to TDF in chronic hepatitis B (hepatitis B e-antigen [HBeAg])-positive and HBV-     deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center,     one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who     have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The     study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV.     After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects     will be screened to achieve 65 evaluable subjects.   "
2166|NCT03257553|"     Necrotizing enterocolitis continues to be a disease that is associated with significant     morbidity and mortality in premature infants due to advances in neonatal intensive care that     increase the survival rate of extremely low birth weight infants (below 1,000 gram)   "
2167|NCT03257540|"     The goal of this research study is to determine if union rates are affected by early     weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.      The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis     procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing     protocol will be non-inferior to union rates previously published for this procedure.   "
2079|NCT03258697|"     Total joint replacement is an ideal procedure to treat end stage joint disease. Good post-op     pain relief could accelerate patient recovery and rehabilitation, and decrease admission days     and medical cost. Local injection of LevoBupivacaine is an effective method in post-operative     pain control. The effectiveness of local analgesia was noticed clinically. However, thorough     studies about the pharmacokinetics of LevoBupivacaine, maintenance of effect, influence of     post-operative rehabilitation are not well studied in different way of injection. The purpose     of this study is to evaluate and analyze the pharmacokinetics and effect of local     Levobupivacaine injection in different ways, the amount of post-operative fentanyl     requirement after local injection, time to first fentanyl request, pain score, immediate     post-operative function, side effect of analgesic agents, and medical cost, and to improve     the quality of total joint replacement post-operative care.   "
2080|NCT03258684|"     In this prospective clinical study, the investigators compare the outcome and clinical course     of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and     thiamine (treatment group) with a control group treated in the investigators' ICU. The     primary outcome is hospital survival. A propensity score is generated to adjust the primary     outcome.There is 50 participants in each group.   "
2081|NCT03258671|"     This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or     cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for     the treatment of stage IV non-small cell lung cancer. Patients with non-small cell lung     cancer have a risk of the tumour in the lung recurring or progressing after treatment.      In this study, the investigators aim to verify the following hypothesis:        -  whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy,          Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung          recurring or progressing similarily.        -  Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal          tissue dose/volume tolerance than concurrent regimen.        -  the survival can be improved by using this new molecular Target-radiotherapy method.   "
2082|NCT03258658|"     This is a Phase I clinical study to determine the safety and efficacy of using autologous,     engineered urethral constructs for the treatment of urethral strictures in adult males.      The proposed study design is a prospective non-randomized and uncontrolled single-center     investigation. Autologous urothelial cells (UCs) and smooth muscle cells (SMCs), obtained     from enrolled male subjects' bladder tissue samples, will be culture expanded in vitro and     used to seed tubular PGA scaffolds to create autologous urethral constructs for the repair of     urethral strictures.   "
2083|NCT03258645|"     This is an observational study in patients with non-valvular atrial fibrillation (NVAF)     presenting to the hospital with a first acute ischemic stroke based on existing data recorded     in the SITS International Registry (located in Sweden) by physicians in several European     countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain,     Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia,     Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.      The aim of this study is to explore the current real world use of dabigatran for stroke     prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European     patients registered in the SITS registry will be considered; countries of origin are not     known a priori.   "
7809|NCT03183661|"     This is an open-label follow up study to evaluate the safety for the subjects with     ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.   "
2084|NCT03258632|"     This project aims to help Veterans who are in the hospital and have untreated alcohol     problems. First, the investigators will adapt a Decision Aid that explains alcohol-related     treatment options and their risks and benefits. Then, the investigators will determine the     effectiveness of an intervention called DO-MoST (for Drinking Options-Motivate, Shared     Decisions, Telemonitor), whereby a Decision Coach helps Veterans make decisions about     alcohol-related behaviors and treatments they prefer, and keeps in contact by phone to     continue to help with drinking and treatment decisions. DO-MoST is designed to increase rates     at which Veterans decide to reduce or quit drinking, and begin and remain in treatment, and     to improve drinking- and medical-related outcomes over time. It may also decrease Veterans'     use of expensive health services such as hospitalizations and emergency visits. Finally, the     investigators will study how VA can use DO-MoST on an ongoing, more widespread basis. The     project should increase patient-centered health care for Veterans with alcohol problems to     benefit their recovery.   "
2085|NCT03258619|"     Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of     cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response     to the ACTH stimulation test, it is recommended to systematically start steroid replacement     therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not     respond to fluid resuscitation and who continue to suffer from haemodynamic instability     despite increasing doses of noradrenaline.      The interest of this corticosteroid therapy lies in its ability to reduce the duration of     treatment with catecholamines, though the results are conflicting with regard to an eventual     benefit for mortality.      Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and     secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood     glucose dysregulation.      Today, there is no way to identify a population of patients who respond to corticosteroid     therapy.      From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also     exert mineralocorticoid effects able to compensate for the impaired renin angiotensin     aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.      This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is     defined by a plasma aldosterone/ plasma renin ratio < 2. It is associated with natriuresis     >30 mmol/l.      We hypothesise that natriuresis > 30 mmol/l will make it possible to identify patients who     respond to steroid replacement therapy in terms of catecholamine use.   "
2090|NCT03258554|"     This randomized phase II/III trial studies how well radiation therapy works with durvalumab     or cetuximab in treating patients with stage III-IVB head and neck cancer who cannot take     cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Monoclonal antibodies, such as durvalumab and cetuximab, may interfere with the ability of     tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will     work better than the usual therapy of radiation therapy with cetuximab in treating patients     with head and neck cancer.   "
2091|NCT03258541|"     For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/-     chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing     local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects,     especially in terms of impaired sexual function. For females, pelvic RT is frequently     associated to long-term complications such as vaginal stenosis (VS), vaginal dryness, and     dyspareunia, while in men RT doses delivered to the neurovascular peri-prostatic bundles and     penile bulb have been associated to the risk to develop erectile dysfunction.      In prostate cancer, hydrogel spacers have been evaluated to create space between the target     (prostate) and the organ (rectum) to be spared during radiotherapy treatments. Clinical     studies have shown the ease of spacer application; patient tolerance and, good clinical     outcomes (decrease in rectal toxicities).      This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel     spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.   "
2092|NCT03258528|"     Objective: to evaluate the effect of right lateral positioning in comparison with supine     positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents     in ventilated preterm neonates. Study design: This randomized controlled trial was conducted     on 60 ventilated preterm neonates < 35 weeks. They were randomized into 2 groups; one group     composed of 30 neonates that were nursed in right lateral position for 6 hours while the     other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal     aspirate sample was obtained from each neonate in both groups just after the end of 6 hours     and pepsin level was measured.   "
2093|NCT03258515|"     This is a randomized, placebo-controlled, double-blind, 3-way crossover phase I study being     conducted on healthy volunteers to investigate the effect of single dose of AZD6094 (600 mg)     on cardiac repolarization under well-controlled conditions in accordance with the     International Council for Harmonization (ICH) E14 guidelines. An open-label Moxifloxacin (400     mg), a fluoroquinolone broad spectrum antibiotic will be used as a appositive control for the     time between the start of the Q wave and the end of the T wave (QT) prolongation in     accordance with ICH E14 guidelines, to establish assay sensitivity. The core study consists     of screening period, 3 treatment period (AZD6094, placebo and moxifloxacin; with a minimum     washout period of 14 days between each treatment period) and follow-up. The study drugs will     be administered orally. The study is planned to determine effect of AZD6094 at therapeutic     dose, safety and tolerability. This study provides adequate and well-controlled mechanisms to     deal with potential bias, facilitate identification of effects related to investigational     product (IMP) administration and tolerability issues.   "
2094|NCT03258502|"     The main aims of the study are to assess the safety, pharmacokinetics and antiviral activity     of multiple doses of RV521 compared to placebo in healthy adult subjects infected with     Respiratory Syncytial Virus (RSV) in the Virus Challenge Model   "
2095|NCT03258489|"     Hypertension is considered a serious public health problem. The imbalance in autonomic     nervous system (ANS) activity is one of the main triggers in the development and maintenance     of hypertension. The non-pharmacological management of this disease is an important resource,     especially in refractory hypertensive patients or in hypertensive crises, where the     pharmacological treatment does not present an efficient response. It is known that     transcutaneous electrical nerve stimulation (TENS) is capable of modifying the autonomic     balance, however, the effects of Interferential electrical stimulation (IES) on this system     in normotensive and hypertensive volunteers are not yet known. These electrotherapeutic     resources may be a non-pharmacological tool supporting the management of hypertension. The     objective of this research is to study the effects of different TENS and IC parameters on     cardiovascular variables of normotensive volunteers and hypertensive patients.   "
2113|NCT03258255|"     The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal     block compared with penil block for pediatric patients undergoing circumsion concerning     postoperative analgesic consumption within 24 hours.   "
2114|NCT03258242|"     This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients     with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of     participates will receive Keluo Xin capsules while other one third will receive placebo.   "
2115|NCT03258229|"     This study was conducted to investigate the effects of daily supplementation of Angelica     gigas N. extract on improvement of Hyperglycemia .   "
7941|NCT03181919|"     the aim of the study is to compare between the step-up and conventional protocols in     ovulation induction in infertile women with PCOS   "
2096|NCT03258476|"     Teenagers are invited to take part voluntarily in a research study of a study drug known as     guanfacine extended release (Intuniv™) and a type of psychotherapy called Mindfulness Skills     Training which teaches people how to focus on the present moment in a nonjudgmental manner to     help them cope with their stresses and worries. Teenagers are being asked to take part in     this study if they have had traumatic stress related over arousal symptoms. He/she may also     have difficulties with worries, anxiety, temper, aggression, quick mood changes, behavior     problems, and/or difficulties with symptoms of Attention Deficit Hyperactivity Disorder     (ADHD) including inattention, hyperactivity, and impulsivity with or without Posttraumatic     Stress Disorder (PTSD); and is not responding adequately to his/her current treatment.      The primary purpose of the teenager's participation in this study is to help answer the     following research question(s), and not to provide treatment for his or her condition:        -  To investigate if Intuniv™ helps for the symptoms of traumatic stress and emotional and          behavioral overarousal in children with a history of traumatic developmental stress with          and without PTSD.        -  To investigate if Intuniv™ helps your teenager engage with and benefit from Mindfulness          Skills Training therapy        -  To better understand how Intuniv™ works in the brain.        -  To investigate how well your child tolerates Intuniv™ during the study.   "
2097|NCT03258463|"     This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico     and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico .   "
2369|NCT03254875|"     The aim of the study is to evaluate whether a screening-based individually tailored nurse     navigator intervention compared to standard care significantly reduce psychological and     physical symptoms among women being treated for breast cancer who had moderate-to-severe     distress (score ≥ 7 on the distress thermometer).   "
2098|NCT03258450|"     Studies have reported about one-third to half of advanced cancer patients experience     psychological distress yet the mental healthcare needs of these patients are not properly     assessed and addressed. Patients with advanced colorectal cancer can face unique challenges     that are stoma- or bowel-related in addition to other symptom burden such as pain, fatigue,     and existential distress that have deleterious consequences on their psychological and social     functioning. This pilot study aims to test an intervention for patients specifically with     advanced colorectal cancer that incorporates culturally-appropriate topics. Using a     randomized selection design, we will investigate the feasibility and acceptability of the     intervention and obtain an initial estimate of efficacy of the intervention. This pilot study     will yield useful information to inform the preparation of a larger, phase III confirmatory     study.   "
2099|NCT03258437|"     This study was conducted to investigate the effects of daily supplementation of Allium cepa     L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.   "
2100|NCT03258424|"     The trial will consist of a single treatment group enrolling adult subjects with CF on     background therapy with KALYDECO®. Approximately 16 subjects will be enrolled.   "
2101|NCT03258411|"     Evaluating and comparing the short term effects of different palatal expanders on the amount     of palatal expansion and buccal tipping of posterior teeth.      Hypothesis:      H0: There is no difference in the short term effects between the different palatal expanders.      H1: There is a significant difference in the short term effects between the different palatal     expanders.   "
2102|NCT03258398|"     This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS     relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the     safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of     avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended     dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508     at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2     will also evaluate pharmacokinetics (PK) and pharmacodynamics.   "
2103|NCT03258385|"     Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth     defects and common complications (e.g. intrauterine growth restriction, neural tube defects),     and possibly immune function impairment. The newborns and infants of B12-deficient mothers     have low B12 stores at birth, further exacerbated by a very low concentration of B12 in     breast milk that may hinder their growth and development. In regions such as Bangladesh, many     women of reproductive age have inadequate B12 status, probably due to low intake of animal     source food. Vitamin B12 intake and status in pregnancy and lactation is potentially     insufficient to prevent impaired child development and immune function related to inadequate     B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through     fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1)     biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive     immunity in infants; (3) neurological and cognitive function in infants.   "
2104|NCT03258372|"     This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of     the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the     exposure of mifepristone at 2 dose levels.   "
2105|NCT03258359|"     This study will evaluate the safety of autologous T cells that have been immunized ex vivo     with patient-specific MDS stem cell neoantigens in patients with MDS.   "
2106|NCT03258346|"     A research study regarding the body's response to several weeks of training using short     sprints and pomegranate juice supplementation   "
2107|NCT03258333|"     In this prospective single-center study included 60 patients with a severe degenerative     aortic stenosis and small aortic annulus (<21 mm) who underwent standard AVR with stented     bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium     (Ozaki procedure) (group 2, n=30)   "
2108|NCT03258320|"     Current agents administered in therapeutic regimens of prostate cancer employ different     mechanisms to eliminate neoplastic cells by inducing substantial apoptosis and causing tumor     regression. Treatment with neoadjuvant chemotherapy before radical prostatectomy may better     control the tumor before it has the chance to convert into the disease of     castration-resistant prostate cancer (CRPC), which is finally refractory to most modalities     of clinical intervention with a clinically lethal nature.   "
2109|NCT03258307|"     Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in     treatment of gynecological malignancy especially ovarian cancer and some advanced stage     endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone     secrete from adipose tissue. These regulate matabolic process.      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,     Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with     gynecological malignancy performed omentectomy or not   "
2116|NCT03258216|"     The Automatic Tongue Diagnosis System (ATDS) was developed to capture tongue images and     extract features reliably to assist the diagnosis of TCM practitioners.This project will     employ the ATDS verified to extract the tongue features of patients with upper     gastrointestinal disorders, such as peptic ulcer, etc. A TCM indices derived through the     non-intrusive tongue diagnosis procedure can provide valuable information for clinical     doctors to analyze the current status of a patient and dynamically schedule a treatment plan,     facilitating early detection and diagnosis of upper gastrointestinal disorders.   "
2168|NCT03257527|"     The study is designed to compare the efficacy of two programs intended to improve happiness     and well-being among healthy, community adults between the ages of 25 and 75 years.     Participants will complete either an in-person program (ENHANCE) or a mindfulness-based     stress reduction (MBSR) self-help program over 3-months. The ENHANCE program will include     12-weekly sessions based on researched principles of happiness. Alternatively, the MBSR     self-help guide will teach ways to replace stress-promoting habits. Participants will be     asked to complete a series of measures at three points of the study: at the start of the     study, the end of the study, and 3-months following the study.   "
2169|NCT03257514|"     The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar     healing after cesarean section by using saline contrast sonohysterography   "
15246|NCT03085901|"     This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that     of Tecnis toric IOL.   "
2117|NCT03258203|"     The purpose of this study is to test the interactions between the genes and diet     interventions varying in macronutrient intake on glycemic, waist circumference, body weight,     visceral fat and lipids changes. In the POUNDS LOST, all of the 811 participants DNA was     extracted from the buffy coat fraction of centrifuged blood using the QIAmp blood kit     (Qiagen, Chatsworth, CA). Single nucleotide polymorphisms were genotyped using the OpenArray™     SNP genotyping system (BioTrove, Woburn, MA). The study is only accepting participants in the     Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in     Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.      Besides, the investigators integrated novel pathway analyses in large cohorts and     comprehensive genetic analyses on long-term weight loss and mechanisms in randomized diet     intervention trials would provide very important evidence to unravel the etiology of obesity,     and have significant public health and clinical implications. Establishing relationship     between genetic variants and diets in determining weight change will help identify     individuals at high risk for obesity especially when adherent to specific diet.   "
2118|NCT03258190|"     Lime powder regimen (LPR) is a limeade-derived composition enrichs with citrate/citric acid     and potassium. LPR was invented to treat the renal stone patients with high risk of stone     recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse     effect than current standard medicine.   "
2119|NCT03258177|"     The purpose of this study is to implement and evaluate postoperative virtual care visits for     patients who undergo a laparoscopic appendectomy or laparoscopic cholecystectomy. We aim to     better understand whether postoperative virtual care visits will not result in a greater     composite measure of the occurrence of hospital encounters within Carolinas HealthCare System     (CHS) for the 30 days following surgery than standard in-person clinic care. We also aim to     better understand whether postoperative virtual care visits provide time and cost savings,     and provide equal or improved patient satisfaction and convenience.   "
2120|NCT03258164|"     The purpose of the present study is to examine whether enrichment of a fat graft with     autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic     use, will significantly improve the results of conventional lipofilling and synthetic facial     fillers, thereby being able to offer a safer, more natural and long-lasting alternative to     current artificial solutions for cosmetic patients.   "
2121|NCT03258151|"     Taxanes are one of the most active agents in the treatment of many kinds of solid tumors,     mainly including paclitaxel and docetaxel. However, variability in toxicity and response     remains a major problem for patients receiving taxanes. It is general that there are many     factors for individual differences of drugs in clinical application, of which genetic factors     accounted for more than 20%. Toxicities of docetaxel, such as myelosuppression, neurotoxicity     or mucositis, were evaluated for possible relationship with pharmacogenetic polymorphisms in     several candidate gene and genome-wide association studies. Due to the levels of evidence of     those studies are low and lack of sufficient research data of Chinese, it has the important     significance in studying individual differences of docetaxel in toxicities, through the     pharmacogenomics research.      The aim of this study is to evaluating the association genetic polymorphisms with     docetaxel-based chemotherapy toxicities in chinese solid tumor patients. By detecting the     gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG)     correlation of docetaxel and provide scientific basis for precise medication guide for people     to use docetaxel.   "
2122|NCT03258138|"     Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes     (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation)     are often recommended to prevent or manage these conditions, but changing habits is     difficult. Mental health can play a role in the ability to seek out and follow through on the     changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely     addressed, and access to mental health services is often limited. Furthermore, individuals     are influenced by factors at the individual, interpersonal, community and policy levels     (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and     need to be addressed in order for individuals to make sustainable lifestyle changes.      A new year-long person-centered healthy lifestyles program is proposed to address the how     to gap in making lifestyle changes through a combination of individual and group sessions.     The feasibility and implementation of this new program will be evaluated through a pilot     study looking at the full healthy lifestyles program compared to a less intensive version of     the program. The study's hypothesis is that the full program will be feasible, acceptable and     more effective for helping participants move across stages of change and for meeting their     goals than the less intensive program.   "
2123|NCT03258125|"     Preeclampsia is a pregnancy related disease characterized by the new onset of hypertension     and proteinuria after 20 weeks of gestation in previously normotensive women. PE is one of     the most challenging diseases in obstetrics worldwide that affects 2-8 % of pregnancies     causing both morbidity and mortality of both mother and fetus.   "
2124|NCT03258112|"     Ventricular arrhythmias arising from cardiac outflow tract affect quality of life and can     cause decrease in left ventricular ejection fraction.      Drugs used for treating those arrhytmias may be ineffective or may have side effects.      Radiofrequency catheter ablation can be used safely for treatment of outflow tract     arrhythmias.      There are different sites where those ventricular arrhythmias may originates, each site has     different electrocardiographic characteristics, different procedural success rates and     challenges in localization and ablation.   "
2193|NCT03257176|"     This is a shortened interrupted time series pilot evaluation over a twelve month period to     evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce     men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce     gender inequality.   "
2170|NCT03257501|"     This is a pivotal, non-randomized, single arm, multi-center, prospective, non-significant     risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.   "
2171|NCT03257488|"     This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive     sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial     hypertension. Results are compared with a modified portable sleep apnea testing (type III     portable monitoring: Somnocheck 2 Weinmann).   "
17352|NCT03058406|"     The purpose of this study is to understand safety and efficacy in participants with soft     tissue sarcomas.   "
2125|NCT03258099|"     Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors.     However, variability in toxicity and response remains a major problem for patients receiving     capecitabine. It is general that there are many factors for individual differences of drugs     in clinical application, of which genetic factors accounted for more than 20%. Toxicities of     capecitabine, such as diarrhea, hand-foot syndrome or anemia, were evaluated for possible     relationship with pharmacogenetic polymorphisms in several pharmacogenomics studies. Due to     the levels of evidence of those studies are low and lack of sufficient research data of     Chinese, it has the important significance in studying individual differences of capecitabine     in toxicities, through the pharmacogenomics research.      The aim of this study is to evaluating the association genetic polymorphisms with     capecitabine-based chemotherapy toxicities in chinese solid tumor patients. By detecting the     gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG)     correlation of capecitabine and provide scientific basis for precise medication guide for     people to use capecitabine.   "
2126|NCT03258086|"     Vitamin D is so-called sunshine vitamin,it is synthesized in the skin during exposure to     the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure     between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back,     or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also     found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.      Vitamin D supplement is recommended in all infants until enough formula, milk, or other food     sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type     1 diabetes is an autoimmune disease, and the self immune system plays a central role in the     destruction of the beta cell of pancrease.   "
2127|NCT03258073|"     In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training     and intermittent opportunity to maintain skills in managing delivery complications and acute     newborn and pediatric conditions. Interventions like effective resuscitation assistance at     the time of birth are lifesaving. Every 30 second delay in establishing effective     resuscitation at birth increases the risk of death by 16%. The purpose of this study is to     test whether medical simulation can improve acute care skills and confidence related to     maternal and pediatric care emergencies.   "
2128|NCT03258060|"     Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to     improve the efficiency of the heartbeat. This treatment is used routinely in patients with     heart failure and a delay in electrical conduction across the heart seen on the surface ECG     (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal     electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see     if cardiac MRI can be used to select patients with normal electrical conduction for CRT,     therefore expanding the number of people who would stand to benefit from this treatment.   "
2129|NCT03258047|"     It's a single arm, open label prospective study, in which the safety and efficacy of     autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.      Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.   "
2130|NCT03258034|"     The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy     occasionally converts it to a resectable cancer. Previous studies showed patients with ELM     gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative     surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel     targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the     patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is     to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the     conversion therapys of ELM gastric cancer.   "
2131|NCT03258021|"     The purpose of this post-authorisation medical device study is to obtain real life data on     the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine     clinical care in Germany. Patients with newly diagnosed GBM and clinical indication for     TTFields treatment will be enrolled in the study after signing Informed consent to use their     data and process it centrally for research purposes. The clinical indication for TTFields is     one of the inclusion criteria and is defined prior to inclusion by the treating physician.     The patient's decision regarding TTFields treatment is part of the observation and will be     assessed within the baseline visit.   "
2132|NCT03258008|"     The goal of this clinical research study is to learn if utomilumab, when given alone or     combined with ISA101b, is able to shrink or slow the growth of tumors in patients with     incurable HPV+ oropharyngeal squamous cell carcinoma.   "
2133|NCT03257995|"     This study is a randomized, double-blind, placebo-controlled, three-period cross-over study     in approximately 54 subjects with asthma.   "
2134|NCT03257982|"     This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI     and FES technology with a view to the inexpensive equipment eventually being used for home     use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients     discharged from hospital.   "
2150|NCT03257761|"     This phase Ib trial studies the side effects and best dose of guadecitabine and how well it     works when given together with durvalumab in treating patients with liver, pancreatic, bile     duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as durvalumab, may block tumor growth in different ways by     targeting certain cells. Giving guadecitabine and durvalumab may work better in treating     patients with liver, pancreatic, bile duct, or gallbladder cancer.   "
2163|NCT03257592|"     Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia,     involve an inflammatory component thought to specifically involve glial cell activation. The     Investigators has been concerned with the development of tools for noninvasive imaging of     inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based     neuroimaging with carbon-11     N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide,     ([11C]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative     marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder,     type I. The investigators will focus on patients in the early stages of disease (within first     five years of onset of schizophrenia diagnosis and within first five years of first manis,     respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on     our results.   "
2135|NCT03257969|"     The rise of oral anticancer drugs favors outpatient care but exposes patients to new risks     compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate     management of side effects and interactions with other co-prescribed drugs. Latrogenic risk     of these treatments is reinforced in older patients with frequent comorbidities, taking     multiple pharmaceutical treatments for long periods and followed by several prescribers.      The literature reports an emergence of drug related problems (DRP) in more than 90% of     patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced     efficacy and potentiation of toxicity) are all the more important that outpatient monitoring     of treatments prescribed at the hospital remains underdeveloped due to default of     coordination between these two settings.      Medical care and prevention of these DRP are difficult because of a lack of information and     tools shared between hospital and liberal actors. Experiments are developed according to     different organizational models, frequently focused on the pharmaceutical analysis of     prescriptions, the detection of DRP and their control, but they stay still undervalued. In     this context, the French Society of Oncological Pharmacology (SFPO - Société Française de     Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien     website and proposes to assess the impact of a program of pharmaceutical interventions named     DROP. The hypothesis of the study is that the DROP program will secure the medical care of     patients with oral anticancer drugs compared to the usual care.   "
2136|NCT03257943|"     A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing     Ivermectin Lotion, 0.5%   "
2137|NCT03257930|"     Use of ethanol injection in treatment of cystic thyroid nodule   "
2138|NCT03257917|"     The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses     and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this     objective, MBC patients will be asked to participate in a short, 37-question survey asking     questions about the financial burden, OOP expenses, and opportunity costs related to their     cancer care   "
2139|NCT03257904|"     Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in     neurocritical care (NCCU) around the world. Uncertainties remain around intracranial pressure     monitoring both in traumatic and non-traumatic brain injury, and variation in clinical     practice of intracranial pressure monitoring exists between neurocritical care units.      The objectives of the study will explore intracranial pressure monitoring variation in     practice to prioritise uncertainties in the clinical management of critical care patients     with acute brain injury and support further collaborative hypotheses-based prospective     studies.   "
2140|NCT03257891|"     Adrenocortical cancer (ACC) is a rare aggressive tumor. The treatment of metastatic ACC is     challenging and the current available treatments are mitotane, chemotherapy or the     combination of both. Prognosis in locally advanced inoperable and metastatic ACC patients     still remains poor, the 5-year overall survival being <15%. New treatment strategies are     therefore needed. The taxanes are a class of drugs targeting the microtubules that have shown     to be effective in the treatment of several malignancies but have not been fully developed in     patients with ACC. Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro     and stabilizes microtubules against cold-induced depolymerization as efficiently as     docetaxel. Cabazitaxel was selected for development based on a better antiproliferative     activity on resistant cell lines than docetaxel. The activity of the drug against several     malignancies is currently tested in ongoing prospective studies, but to our knowledge neither     preclinical nor clinical studies are currently testing cabaztaxel in ACC. This study is aimed     to demonstrate that cabazitaxel is active in ACC, but the drug was never tested before in     this clinical setting. A prospective, non-randomized, multicentre, open label, single arm,     phase II study will be conducted in patients with advanced ACC. The phase II study will be     conducted in 2 different Italian Institutions that are reference centers for ACC.   "
2141|NCT03257878|"     To compare the health related quality of life of patients with systemic sclerosis with other     rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus and Sjogren's     syndrome.   "
2142|NCT03257865|"     To Demonstrate the Efficacy of Brexpiprazole for the Acute Treatment of Manic Episodes, With     or Without Mixed Features, in Subjects with a Diagnosis of Bipolar I Disorder   "
2143|NCT03257852|"     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of     ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate     (MTX).   "
2144|NCT03257839|"     The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear     ring‐array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and     K142517 for use as both a B‐mode ultrasonic breast imaging system and color imaging of     transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a     replacement for screening mammography.      SoftVue uses non‐ionizing ultrasound energy to generate tomographic image volumes of the     whole breast. While the patient lays prone on a padded table with one breast comfortably     submerged in a bath of warm water, a ring‐shaped transducer, 22 cm in diameter, encircles the     breast and pulses low‐frequency sound waves through the water and into the breast tissue.     More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive     ultrasound signals to analyze echoes from the breast anatomy in all directions, from the     chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound     waves off of tissue boundaries and structures within the breast, but because the transducer     surrounds the whole breast, SoftVue also captures signals that are transmitted through the     breast. This additional transmission data enhances the visualization of the anatomic     structure of the breast tissue and is not currently available in any other commercially     marketed breast ultrasound device.      This prospective, multicenter, multi‐arm, clinical case collection program is IRB‐approved     and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki     and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500     women at a total of up to 8 clinical sites. The design of this protocol is strictly limited     to case collection; all investigational and statistical plans for future analyses will be     prepared and registered separately, if they are applicable to the requirements of FDAAA 801.      Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense     breast parenchyma (BI‐RADS breast composition category c or d). Matched triads of 2D digital     mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast     ultrasound (SV)exams, from the same patient, with demographic information and clinical     outcome data, will be collected during the same screening imaging episode. Ultrasound     characteristics for all types of lesions, whether they are benign or malignant, will be     collected, as well as objective and subjective breast density composition data.      The exams and clinical data accumulated in this prospective case collection (PCC) protocol     will populate a database from which future investigations may be designed for peer reviewed     publication, development of user training curriculums, building teaching case, and creating     new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in     ROC Reader Study (protocol DMT‐2015.002), which will be separately registered and is designed     to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an     adjunct to screening mammography. The results of this ROC Reader Study will be submitted to     the FDA for their consideration of a PMA application for SoftVue.   "
2145|NCT03257826|"     The aim of this study was to investigate the effect of percutaneous kirschner wire in     management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This     study was to determine the union rates of congenital pseudarthrosis in children operated     before 1 year of age to identify growth abnormalities in the affected limb ,including ankle     valgus,tibia valgus,and shortening.   "
2146|NCT03257813|"     Aim: To demonstrate the non-inferiority of the PRO-122 ophthalmic solution manufactured by     Laboratorios Sophia S.A. de C.V. versus Krytantek Ofteno® ophthalmic solution like     hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension.      Study design: a multicentric, prospective, crossover (2x2), double blind clinical study.     Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.     Patients in the period 1: In the first sequence 60 patients will be assigned to receive the     ophthalmic solution: Krytantek Ofteno ® (timolol 0.5%%/brimonidine 0.2%/dorzolamide 2%) 1     drop B.I.D. during 30 days and the second sequence 60 patients will be assigned to receive     the ophthalmic solution: PRO-122 1 drop B.I.D. during 30 days in the same period. Washout     period: 20 hours. Patients in the period 2: the pharmacological intervention change to the     opposite therapy for 30 days   "
2147|NCT03257800|"     This interventional double-blind, randomized trial has included120 children of American     Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either     sex, scheduled for outpatient minor surgery under general anesthesia.This study examined     whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion     conditions and preserve hemodynamic state in patients.   "
2148|NCT03257787|"     This study investigates the performance of a new adhesive strip when impacted by output.   "
2149|NCT03257774|"     The study investigates the impanct real output has on the adhesion of a new adhesive   "
2151|NCT03257748|"     Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of     signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and     neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is     affected with at least one sign. The disorder progresses with orofacial pain, muscle pain     involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block,     mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture,     trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase     in emotional stress. Studies have demonstrated that phototherapy is an efficient option for     the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the     proposed study is to analyze the effects of low-level laser therapy and light-emitting diode     (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled,     double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70     years of age allocated to either a laser group or LED group submitted to twelve sessions of     phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all     participants. Pain will be measured using the visual analog scale. Orofacial function will be     measured based on maximum vertical mandibular movement and muscle tension (determined through     palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius     muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also     be performed.   "
2152|NCT03257735|"     Primary lung cancer is one of the most common malignancies in China, with 57 percent of     patients being diagnosed at advanced stage. At present, advanced lung cancer has entered the     era of precise treatment. So it is very important to determine the gene mutation status of     the tumor and prescribe drugs at the targets. Liquid biopsy is a suitable alternative when     tumor tissues are difficult to obtain. Liquid biopsy technique refers to the use of human     body fluid as a sample source to detect the information of related diseases, including blood,     urine, saliva and cerebrospinal fluid. It is non-invasive, fast and simple, and can avoid the     problem of insufficient sample size and support for repeated sampling to continuously monitor     disease.      With the increasing incidence of lung cancer and the development of diagnosis and treatment     technology, the survival period of patients has been extended, and the incidence and     diagnosis rate of the brain metastasis of lung cancer have increased year by year. The brain     metastasis of lung cancer is the most common type of brain metastatic tumor. The incidence     rate is about 40-50%, and the prognosis is poor——the natural median survival period is about     1-2 months. Because of the impractical intracranial tumor biopsy and very low level of DNA in     peripheral blood, cerebrospinal fluid, which makes close contact with brain tumors, becomes     potential available samples. Several studies have shown that genetic testing of cerebrospinal     fluid is feasible. Therefore, this study aims to test the cerebrospinal fluid, blood and     tissue by the latest second-generation sequencing technology at different time points, to     dynamically monitor the gene mutation status of cerebrospinal fluid, blood and tissue, to     explore the role of cerebrospinal fluid biopsy in the diagnosis and treatment of non-small     cell lung cancer with brain metastases.   "
2153|NCT03257722|"     This is a phase 1b/2 study to determine the safety and effectiveness of the combination of     pembrolizumab and idelalisib in NSCLC patients whose disease has stopped responding to immune     therapy. This study is being done to see if adding another immune modulator (idelalisib) to     standard pembrolizumab will increase response rates, compared to the response seen with     pembrolizumab alone.   "
2154|NCT03257709|"     This study compares two established surgical treatments for acetabular labral tears. Patients     will be prospectively recruited and randomised to either labral repair or debridement. All     patients will be followed for 2 years after intervention with a primary outcome assessment at     6 months.   "
2155|NCT03257696|"     Quality of care depends strongly on oral communication with patients. Stroke patients, who     have language disorders, have understanding difficulties, but also have difficulties in     expressing their needs and in being understood. Available tools do not allow a professional     consensus on the assessment of patients' ability to answer reliably to questions asked by     caregivers. The investigators propose an answer reliability assessment tool based on yes or     no questions. The goal of the present study is to define an optimal score for defining the     test positivity, as a compromise between sensitivity and specificity, and by emphasizing the     negative predictive value.   "
2156|NCT03257683|"     The purpose of this study is to collect data to determine if the medication, Ranolazine,     effects heart muscle function in patients who have areas of non-revascularizable heart     muscle.   "
2157|NCT03257670|"     This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective     than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse     in women who are breast cancer survivors. This study will also be looking at whether or not     the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function     before and after treatment.   "
2158|NCT03257657|"     Low-income and minority women are at increased risk for postpartum weight retention (i.e.     retaining weight after pregnancy) and consequent persistent obesity. Women who are obese     pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the     postpartum period than non-obese women. Aims for this pilot study are listed below:      Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss     intervention delivered in a WIC setting to a population of low-income, predominantly     racial/ethnic minority, obese, postpartum women.      Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy,     readiness to change, motivations to eat between intervention and control participants to     determine preliminary intervention efficacy over a 12-week period.   "
2159|NCT03257644|"     The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics     (PK) of topical INCB018424 cream applied to pediatric subjects (age ≥ 12 to 17 years) with     atopic dermatitis (AD).   "
2161|NCT03257618|"     Studying QoL in patients DLGG receiving TMZ is complex because of the multiples interactions     between tumor characteristics, neurocognitive functioning, treatments, environment and     psychopathological context in which these patients experience symptoms. It is, however,     important to accurately evaluate these aspects in consideration of the young age, generally     preserved QoL at the time of diagnosis, possible implications of the disease on the     professional (DLGG patients are often still active), social and familial domain, and     relatively long survival of these patients. In the absence of a curative treatment for DLGG,     preserving patients' QoL is indeed a major goal.   "
2184|NCT03257306|"     The specific aim of this study is to validate our hypothesis that the magnetic ureteral     stents have the same amount of adverse effects as the more commonly used non-magnetic     ureteral stents. If this hypothesis would be confirmed then the usage of magnetic ureteral     stents would be justified for both reducing patient discomfort by way of fewer cystoscopies     and possibly also decreasing the overall expenditures of treatment.   "
2172|NCT03257475|"     Cervical cancer is the most common malignant in women with the average five-year overall     survival rate as high as 70%. Radiation therapy is the main treatment for cervical cancer.     Vagina is one of the important organ at risk and also a target organ in the treatment of     cervical cancer patients. Vaginal radiation has serious related complications that affect the     quality of life of patients and therefore needs much clinical attention. But due to lack of     sufficient evidence, the clinical dose to the vagina is limited. ICRU-89 defined the     recto-vaginal reference point (R-V) as a reference point for vaginal dose assessment.     However, the R-V position is affected by applicator placement, vaginal packing and other     factors hence the dose point only do not represent the entire vaginal radiation dose     resulting in some clinical limitations. The latest research in Europe proposed that     PIBS(Posterior-Inferior Border of Symphysis) / PIBS ± 2cm and VRL (vaginal reference length)     may be more reasonable to use to assess vagina radiation doses, but it remains to be further     clinically investigated. Therefore, this study intends to perform radical radiotherapy in     cervical cancer patients and also by recruiting local and foreign hospitals into this study     by recording its PIBS/ PIBS ± 2cm, VRL, R-V point dose, acute and chronic radiation injury     incidence of vagina and other useful data. T-test and chi-square will be used to compare the     data between Asian and European women. Correlation analysis will be used to determine if     there is a relation between R-V and PIBS point dose. Furthermore, logic and or COX regression     model to evaluate PIBS / PIBS ± 2cm and R-V point doses of vaginal radiation injury     relationships, while exploring other relevant factors causing vaginal radiation injury. This     is eventually expected to provide a scientific, simple and reliable reference point for     vaginal dose assessment and clinical dose limit.   "
2173|NCT03257462|"     This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety,     pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with     classic congenital adrenal hyperplasia (CAH).   "
2174|NCT03257449|"     Abstract:      Background: Obesity is a global pandemic affects all age groups and is independent risk     factors for most chronic diseases. Dietary intervention is an essential component of obesity     management. Dietary fibre supplements have the potential to facilitate weight reduction based     on their viscosity. Up to date, the evidence of effects of some fibres on weight is     inadequate, and literature provides insufficient information about the effects of the fibre     viscosity in weight management.      Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the     effectiveness of viscous fibres, (agar, alginate, b-glucan from oat and barley, guar gum,     glucomannan, pectin, PGX, psyllium), on body weight reduction.      Methods: Only randomised controlled trials are accepted. The trails must have one of the     selected fibres as a supplement, and the outcomes must have body weight, BMI, waist     circumference, or body fat percentage. Studies shorter than 4 weeks are excluded. Three     databases, (Medline, EMBASE, and Cochrane library), were searched through 04/03/2016.      Results: After removing duplicates, 82 studies will be reviewed in full. Significance: This     meta-analysis is the first meta-analysis that is based on fibre viscosity, and it will     quantify the effect of each fibre in improving weight loss. It will also direct future     research in the best direction to further explore this area.   "
2175|NCT03257436|"     Prospective, multi-center, single arm, post approval study to be conducted in the United     States.   "
2194|NCT03257163|"     This phase II trial studies how well pembrolizumab works with capecitabine and radiation     therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive     gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability     of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Radiation therapy uses high energy     x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, capecitabine and     radiation therapy may work better at treating gastric cancer.   "
2195|NCT03257150|"     This I/II study will evaluate to see how safe and useful irreversible electroporation (also     called NanoKnife) is in patients with locally advanced pancreatic cancer.   "
2196|NCT03257137|"     This study will investigate the effect of two dietary patterns on sleep outcomes and measures     of reported appetite. Participants will be given two different diets on two separate stays.   "
7810|NCT03183648|"     This is an open-label follow up study to evaluate the safety for the subjects with     ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.   "
2176|NCT03257423|"     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.     Appendicectomy, however, includes operative and postoperative risks despite being a routine     procedure. Several studies have proved promising results of the safety and efficiency of     antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by     the investigators, published in 2015 in the Journal of American Medical Association, also     proved promising results with 73% of patients with uncomplicated appendicitis treated     successfully with antibiotics. None of the patients initially treated with antibiotics that     later had appendectomy had major complications. The results of the APPAC trial suggest that     CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy     is a safe first-line treatment option. Reducing unnecessary appendectomies has also been     shown to lead to significant economic savings. On the other hand, antibiotic therapies have     been shown to have an effect on the normal gut microbiota and are considered an increasing     global health threat underlining the importance of evaluating both short- and long-term     effects of the antimicrobial treatment in old and new indications.      The aims of this randomized prospective study are:        1. To evaluate the possible role and differences in the microbiological etiology of          complicated and uncomplicated appendicitis.        2. To determine the effects of both antibiotic and placebo treatment on the composition of          gut microbiota, and to evaluate how it recovers after the appendicitis-related          antimicrobial treatment (AMT)        3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the          gut microbiota.   "
2185|NCT03257293|"     The goal of this project is to improve patient experience of cystoscopy using a     non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for     urology patients and is usually performed without sedation. However, there is limited     research into reduction of patient discomfort throughout this procedure. The proposed     modification technique was selected based on a well-documented psychological phenomenon in     which only particular moments over the course of an aversive event determine the resultant     perception of the experience. It is hypothesized that implementation of the technique will     decrease the recalled pain intensity of the cystoscopy.   "
2186|NCT03257280|"     This is a prospective randomized controlled clinical trial to clarify the effect of early     oral nutrition introduction after total gastrectomy in gastric cancer patients on the length     of hospital stay, comparing an experimental group vs control group.   "
35320|NCT02823483|"     To determine the phototoxic potential of a topically applied article in human subjects   "
2177|NCT03257397|"     Background Major depression is associated with morbidity and increased mortality. Along with     the psychological strain depression represents a high socioeconomic burden costing Europe     more than €113 billion/year. About one third of patients do not respond to appropriate     therapy. Theta-burst stimulation (TBS), a form of transcranial magnetic stimulation is an     emerging treatment for patients for whom pharmacological treatment is ineffective or not     appropriate. Based on two different theories of prefrontal dysfunction two TBS-protocols     should have the most antidepressant effects. However, no study so far has compared the two     approaches or systematically investigated their differential effects on brain function and on     a symptom level.      Objectives of the study The aim of this study is to test two TBS protocols on symptom     improvement and associated brain function in patients with treatment resistant depression     (TRD): iTBS over bilateral DLPFC and iTBS over left and cTBS over right DLPFC. As stimulation     over non-motor regions offers no direct readout, fMRI at baseline and after treatment will be     harnessed to quantify an effect on brain activity and functional network metrics.      Study population 80 patients with TRD will be enrolled with 40 patients receiving the one,     and 40 patients receiving the other TBS protocol for a treatment period of three weeks.      Study design The study is designed as a longitudinal, randomized and double-blind clinical     trial. At baseline and after treatment, patients will undergo psychiatric testing using     several symptom scales including the Hamilton Depression Rating Scale (HAMD-17), the Beck     Depression Inventory (BDI-II), the Inventory of Depressive Symptomatology (IDS-C) and the     State-Trait Anxiety Inventory (STAI). Changes in HAMD-17 scores are defined as primary     endpoint. Moreover MRI scans before and after treatment will include structural and     functional MRI sequences as well as diffusion weighted imaging (DWI) sequence. Functional     connectivity and BOLD responses will serve as primary imaging endpoints. A follow-up visit 2     weeks and a final examination 4 weeks after treatment will elucidate durability of effects.      Relevance and implications of the study By investigating which approach is superior for which     symptoms our study will contribute to the development of personalized treatment, the     reduction of personal suffering and the reduction of costs and occupational disability.   "
2178|NCT03257384|"     The primary objective is to prospectively identify Operating Room (OR) time delays from the     time the patient who is undergoing total laparoscopic hysterectomy enters the OR to exiting     the OR. This analysis will be used to identify root cause(s) leading to OR delays and define     areas for improvement. The secondary objective is to identify any improvements in OR time     delays and OR utilization following implementation of a standardized framework developed to     increase OR efficiency.   "
2179|NCT03257371|"     With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic     knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle     arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV     changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal     pathology in the medial or lateral femorotibial joint as determined by physical examination,     diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV     changes in any other compartment of the knee, acute injury to any other part of the affected     lower extremity, or inability to comply with the protocol.      After enrollment, patients will undergo standardized knee radiography, and complete     assessments (described below). Size-matched (standard clinical methodology) proximal tibia     with meniscus and distal femur allografts from the same donor will be obtained from a tissue     bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS     technology. The medial or lateral femoral condyle will be replaced using our novel     instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed     and used to replace the entire medial or lateral tibial condyle while sparing the attachments     of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated     using commercial available implants used for bone fixation. In the event that the meniscus     has been detached from the tibial plateau during graft harvest, the periphery of the meniscus     will be sutured to the capsule following standard meniscus transplant procedure.      Patients will undergo controlled post-operative rehabilitation according to standard     protocols for osteochondral with concurrent meniscus allografts.      Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation     Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical     Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS     Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected     knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months     after surgery to evaluate healing, function and evidence for arthrosis.   "
2180|NCT03257358|"     A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)     after treatment with 0.5mg fingolimod   "
2181|NCT03257345|"     Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's     disease. The aim of this study is to capture the early real life UK experience of vedolizumab     including the outcomes of treatment, describing the patient population treated, drug     persistence, IBD control PROM, durable remission, tolerance and safety.   "
2182|NCT03257332|"     BACKGROUND: More than a third of patients whom have been diagnosed with rectal cancer and     treated with curative rectal surgery (low anterior resection) develop faecal incontinence     also known as the low anterior resection syndrome (LARS). Faecal incontinence is a     deliberating and stigmatized problem that can lead to impaired quality of life.      There is limited evidence on efficacy of current treatment strategies for feacal incontinence     in patients with LARS. Pelvic floor muscle exercise is a simple and non-invasive treatment,     that has shown preliminary positive effects on faecal incontinence and quality of life.     Pelvic floor muscle exercise has the potential to be a cost-effective treatment for faecal     incontinence in subjects with LARS. Despite this, there is limited knowledge about the     relationship between; severity of faecal incontinence and pelvic floor muscle function. To     our knowledge no records exist on this relationship within the first 6 months after low     anterior resection or stoma closure. This type on information is central for future designing     and conducting of expensive randomized trials.      PURPOSE: The purpose of the EDFI-Cohort study, is to determine the incidence, prevalence and     causality of faecal incontinence, quality of life and anorectal muscle function from prior to     stoma closure to 2 years after stoma closure, in subjects whom have been curatively treated     for rectal cancer with low anterior resection.      METHOD: Subjects for the EDFI-Cohort study will be recruited during autumn/winter of 2017 and     throughout 2018, from Department of Surgery, Slagelse Hospital. Subjects should have received     curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant     (radiation/chemo) therapy. Subjects for this study will have been treated with low anterior     resection (e.g. total mesorectal excision (TME) or partial mesorectal excision (PME)) and     scheduled for stoma closure. Prior to inclusion subjects must have received study information     and provided written informed consent to participate in this study.      Sample size: We need to examine a minimum of 50 subjects per year. With our broad inclusion     criteria we aim to include a total of 150 subjects during the 1½ year inclusion period.      Outcomes: Outcomes of patient characteristics (e.g. age, cancer stage and type of surgery)     will be collected at baseline. Self-reported outcomes (e.g. feacal incontinense, quality of     life and sexual function) and a clinical examination on anorectal muscle function will be     collected/performed at prior to stoma closure and 3 weeks, 12 weeks, 6 months, 12 months, 52     months and 104 months after stoma closure.      Statistical analysis: The EDFI-Cohort study is expected to be analysed with both multiple     linear regression and simple linear regression models for the continuous data. In addition we     plan to dichotomize the LARS-score into no/minor or major LARS, and thus analyses on LARS     will be handled with binominal tests.      Patient involvement: Prior to planning of the EDFI-Cohort study, we have performed a single     case-study (spring 2016) on examination procedure, questionnaires and pelvic floor muscle     rehabilitation, this case provided us with valuable information on perspective of testing and     possible evaluation of treatment effect.      Research ethics: Examinations included in this study are all associated with very few if any     adverse events, except from the mild discomfort related to the clinical anorectal examination     itself. Subjects included in this study will receive 6 examinations, whereas care as usual at     Slagelse hospital usually include one examination/contact to the local LARS clinic with no     anorectal examination. Included subjects are more closely monitored and, if need be, might     receive relevant treatment earlier compared to care as usual patients.      Future implications: Results from the EDFI-Cohort study will help guide the design of     randomized controlled trials on treatments of faecal incontinence in subjects whom have been     surgically treated for rectal cancer. With emphasis on establishing the role of anorectal     muscle function in the development faecal incontinence.      Applicability of registrations and approvals: Prior to subject inclusion the EDFI-Cohort     study will need to be approved by the regional research ethics committee of Region of Zealand     including adhering to Danish legislation on 'processing of personal data'. The data     protections agency will be notified prior to project start. Finally, the project will prior     to start be registered at ClinicalTrials.gov.   "
2197|NCT03257124|"     AZD9291 is an oral potent irreversible EGFR TKI selective for sensitizing EGFR mutation and     T790M resistance mutation but sparing wild-type EGFR. Preclinical studies indicate that     AZD9291 has significant exposure in the brain and activity against EGFR mutant brain     metastasis. In addition, anti-tumor activities of AZD9291 in patients with advanced stage     EGFR mutant NSCLC including patients with brain metastasis have been reported in an ongoing     Phase I study. More recently, AZD9291 at a dose of 160mg also showed promising efficacy in     heavily pre-treated patients with leptomeningeal disease from EGFR mutant NSCLC. Among 11     evaluable for response, 6 patients had LM imaging improvement and 3 out of 7 patients with     abnormal neurological exam at baseline had symptomatic improvement. Compared to AZD9291,     other 3rd generation EGFR TKIs, rociletinib or HM61713 has not been reported to be effective     in most of CNS disease of NSCLC. Further, previous studies with AZD9291 showed anecdotal case     series or undetermined for T790M mutation status, indicating more systematic study is     warranted.      Based on these data, we are going to conduct phase II study of AZD9291 in NSCLC patients     harboring T790M mutation who failed EGFR TKIs and brain and/or leptomeningeal metastasis.   "
2183|NCT03257319|"     Prospective single-blind, multicenter, national, randomized, controlled trial in 15 Emergency     Department to compare two ways of morphine titration. The eligible patient is included     immediately after his arrival in the Emergency Department, after being questioned by the     triage nurse about the presence and the intensity of pain, when the VAS is greater than 70     (or EN>7) and after written consent.      After installation into the examination room, patient is randomized in one of two parallel     groups (stratified by sex and center using software) and receives one of the two treatments,     either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control group).      In both groups, titration is defined by a dose of repeated boluses as long as the relief is     not achieved (VAS> 30 or EN >3) and the criteria to stop titration are not met.      A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at a     constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.      Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum of     6 IV injections (one injection every 5 minutes) The stopping criteria, except pain relief,     are linked to the occurrence of side effects and specific cares are described into the     protocol (in case of severe ventilatory depression naloxone titration is provided). Exit     criteria from the emergency room and from the hospital are defined. An information sheet is     delivered.   "
2230|NCT03256695|"     This is a 12-week, multicenter, open-label study to evaluate the relationship between     as-needed usage of ABS eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease     (moderate CE-COPD)/severe CE-COPD in adult patients at least 40 years of age with     exacerbation-prone COPD.   "
2187|NCT03257267|"     The primary objective is to compare overall survival (OS) for patients with recurrent or     metastatic platinum-refractory cervical cancer treated with either REGN2810 or investigator's     choice (IC) chemotherapy.      The secondary objectives are:        -  To compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy        -  To compare overall response rate (ORR) (partial response [PR] + complete response [CR])          of REGN2810 versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors 1.1        -  To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy        -  To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse          events (AE)        -  To compare quality of life (QOL) for patients treated with REGN2810 versus IC          chemotherapy using the European Organization for Research and Treatment of Cancer          Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)   "
2188|NCT03257254|"     12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting     in VLU treated with Varithena   "
2189|NCT03257241|"     The study will include newly-diagnosed AML patients, not suffering acute promyelocytic     leukemia; aged 18-60 years, who are eligible for standard induction chemotherapy. The     patients will be randomized to one standard induction regimen (DAC or DA-90). At day seven     after completion of induction, a bone marrow aspiration with MRD will be performed for an     early evaluation of response to treatment. Patients without bone marrow blast reduction below     10% at day seven after induction will be given a second early induction course. Patients who     do not achieve CR after two induction courses will be randomized to one of the standard     salvage regimens (FLAG-IDA or CLAG-M). Postremission treatment intensity will be adjusted to     risk group based on cytogenetic and molecular risk factors at diagnosis and AML biology     (secondary AML, therapy related AML). Patients with a low risk of relapse will be allocated     to consolidation, with three courses of high doses of Ara-C (HiDAC), or two courses of HiDAC     with subsequent autologous stem cell transplantation. Intermediate- or high-risk patients     will be referred for allogeneic stem cell transplantation, if they have a matched donor.     Until transplantation, consolidation with HiDAC will be continued.   "
2191|NCT03257215|"     Vitamin D is known to have a regulatory influence on both the immune system and skin barrier     function. Studies in paediatric populations have found an inverse association of vitamin D     levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D     as a treatment for AD are limited in number and size. There has never been a     placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose     for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway     genes and response to treatment of AD. This pilot study will be used as a reference to     determine outcomes and feasibility for undertaking a larger and more in depth definitive     study.   "
2202|NCT03257059|"     The aim of this study is to determine whether eating breakfast or having no breakfast has     subsequent beneficial health effects, specifically in relation to glycemic response     throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6     hours after breakfast/lunch.   "
2203|NCT03257046|"     This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study     in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of ITI-214.   "
2204|NCT03257033|"     The study is a multi-center, un-blinded, randomized control study of subjects with locally     advanced pancreatic adenocarcinoma which is unresectable.   "
2205|NCT03257020|"     This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT.     SD-OCT exam will be performed to all patients in this study.   "
2206|NCT03257007|"     The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel     mindfulness meditation-based intervention (MEANING) to usual care for adults with     advanced-stage solid malignancies and their family caregivers.   "
2207|NCT03256994|"     Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal     invasive, endovascular treatment for primary and secondary liver tumours. In France,     SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de     Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated     with SIR-Spheres will be entered into a registry that collects data on the real-life clinical     application of SIRT and reports to the national authorities.   "
2208|NCT03256981|"     HALT is a phase II, randomised multi-centre study with integrated seamless continuation to     phase III trial following acceptable safety and feasibility assessment.      HALT aims to recruit 110 patients with mutation positive advanced NSCLC with oligoprogressive     disease (OPD) following initial response to a Tyrosine Kinase Inhibitor (TKI).   "
2209|NCT03256968|"     The purpose of this study is to explore the combination of ataluren and ivacaftor as a     treatment for patients with nonsense mutation cystic fibrosis   "
2210|NCT03256955|"     Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative     neuromuscular monitoring is standard care. The TOF WATCH SX® monitor is considered as one of     the reference monitoring devices in clinical research and clinical practice. With this     monitor the ulnar nerve is stimulated at the wrist and the force of the movement of the thumb     is measured with acceleromyography. This method requires freedom of movement of the patient's     thumb. Unfortunately this is not always possible due to the constraints of patient     positioning during the operation. The TOF Cuff® monitor is a modified non-invasive blood     pressure cuff that incorporates stimulating electrodes in its inner surface and is based on     the stimulation of the peripheral nerve in the arm (brachial plexus, ulnar and median nerves     principally). The evoked neuromuscular activity is recorded through the changes in pressure     generated in the inner part of the cuff by the muscular activity after the stimulus.     Moreover, this device can be used for non-invasive reading of the blood pressure. This device     has been validated with mechanomyography, but was never been compared with acceleromyography,     which is the most common used neuromuscular monitoring method.   "
2211|NCT03256942|"     Primary objective:      - To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS).      Secondary objectives:        -  To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks          after Etermis 4® injection.        -  To evaluate safety/tolerability of Etermis 4® treatment in lips.   "
25659|NCT02949830|"     The purpose of this study is to determine the long-term safety, tolerability and     pharmacokinetics of ALN-AS1 in AIP patients   "
2212|NCT03256929|"     The propose of the study is a multi-disciplinary project connecting nutritional and health     sciences with social and behavioral sciences, and aimed at understanding the microbiota     changes related to the third age and their effects on mood and mental health. The research     aims are primarily practical: They will explore the influence of the gut flora on depression,     which could help us to recommend diets that might reduce the risk of developing depression.     The novelty of this proposal is in the design of personalized diet-driven microbiota     alterations and health status to modulate depression in elderly. For the first time the     improvement of mental health in the elderly will be studied through a nutritional and food     habits approach based on microbiota changes upon ageing.   "
2213|NCT03256916|"     The primary aim of the trial is to study the impact of nelfinavir on 3 year disease free     survival in patients with advanced carcinoma of cervix receiving standard chemoradiation     (Cisplatin and Radiotherapy).      There will be two study groups. One group will receive standard treatment (concurrent     chemoradiation and brachytherapy) & other group will receive nelfinavir 5-7 days prior to     standard treatment (chemoradiation & brachytherapy).   "
2214|NCT03256903|"     Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used     in usual clinical practice, in patients with trauma and associated pain, treated in Spanish     emergency units.   "
2215|NCT03256890|"     The primary aim is to evaluate impacts of a behavioral intervention called Mindfulness-Based     Blood Pressure Reduction (MB-BP) vs. enhanced usual care control on systolic blood pressure     at 6 months, via a randomized controlled trial.   "
2216|NCT03256877|"     To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of     having bladder cancer.   "
2217|NCT03256864|"     It has been identified that nonadherence to immunosuppressant regimen may cause long-term     graft failure and death in solid organ transplant recipients. Therefore, simplification of     the immunosuppression regimen by reducing daily dosing frequency may improve long-term     outcome. The investigators will examine pharmacokinetics and safety profiles of stable liver     transplant recipients receiving twice-daily TAC with EVR (BID) regimen and then being     converted to once-daily TAC with EVR (QD) regimen over a 6-month study period     post-conversion.   "
2240|NCT03256565|"     Urethral hypermobility, which can be assessed with Q-tip test, has been considered to be     partly responsible for pathogenesis of women with stress urinary incontinence (SUI).     Nonetheless, Q-tip test has lost favor due to patient discomfort. Thus, the purpose of this     study was to search a surrogate for assessment of urethral hypermobility by correlating the     Q-tip angle and the urodynamic variables in women with SUI.   "
2243|NCT03256526|"     IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY,     SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS     WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE   "
2218|NCT03256851|"     Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in     the central nervous system. Although individuals experience mobility (e.g., walking, balance)     impairments that lower quality of life and limit participation in daily activities, one of     the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that     manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately     contributes to increasing disability. The currently available pharmaceutical treatments fail     to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies     such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the     majority of individuals.      Exercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is     seriously limited for many individuals with MS due to geographical location, limited     resources (e.g., financial, transportation), and/or disability. Thus, the development and     evaluation of an alternative delivery method for exercise therapy to target MS-related     fatigue that increases participation and reduces barriers is critical.      In this study, the investigators will compare traditional in-person delivered exercise     therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.   "
2219|NCT03256838|"     To assess the long-term safety and effectiveness of Nephoxil® for the treatment of     hyperphosphatemia in patients with ESRD undergoing dialysis.   "
2220|NCT03256825|"     The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis     decision support on different aspects of antibiotic consumption when implemented alone or     together.   "
2221|NCT03256812|"     To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring     system against the efficacy and stability of an existing outpatient-based electrocardiogram     (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation     ablation, and to test whether such continuous monitoring can better detect arrhythmia that is     undetectable by existing methods and how this may affect treatment outcomes   "
2222|NCT03256799|"     The purpose of this study is to explore the combination of ataluren and ivacaftor as a     treatment for patients with a specific cystic fibrosis mutation   "
2231|NCT03256682|"     The purpose of this study is to verify the effectiveness of mobile video counseling for     workers. Subjects who can participate in the screening evaluation are assigned to one of     face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile     counseling group and the face-to-face counseling group counseld with a total of 4 times, 50     minutes at a time, once a week, and the self-treatment group provides self-education by     providing the stress education kit.   "
2232|NCT03256669|"     Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can     solve the problem to some extent by making a smaller scar but takes more time and need     special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy     and avoid the drawbacks of both.   "
2260|NCT03256292|"     Older hypogonadal obese veterans previously participated in a 6 month lifestyle change     (diet-induced weight loss and exercise) study with or without testosterone replacement     therapy before being followed for the following year at the clinic while receiving standard     of care consisting of diet and exercise counseling (for healthy lifestyle change) and     testosterone replacement therapy. This study will determine if long-term lifestyle change and     testosterone replacement therapy with associated improvement in physical and metabolic health     can be maintained in obese older adults.   "
36876|NCT02803008|"     To evaluate the Sun protection factor efficacy on human skin.   "
2223|NCT03256786|"     The majority of women (> 60%) developed hypothermia and shivering during cesarean delivery.     Core hypothermia may be associated with a number of adverse outcomes in patients, including     shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements,     decreased metabolism and prolonged recovery. Shivering can result in interference with     monitoring, increased tension on wound edges, and increased oxygen consumption.      A previous study has shown several modalities to prevent hypothermia and shivering in     patients undergoing cesarean delivery with spinal anesthesia. But, single modality     intervention have shown marginal or no efficacy.      Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also     produces a lower body sympathectomy that provokes a core to peripheral redistribution of body     heat. It is difficult to treat the core to peripheral redistribution of body heat. However     redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes     core temperature that remains well regulated, but it markedly increases peripheral tissue     heat content. As a result, prewarming reduces the core to peripheral tissue temperature     gradient and the propensity for redistribution after the induction of anesthesia.      We therefore hypothesized that Combined modality active warming consisting of preoperative 15     min of surface warming using a forced air warmer before spinal anesthesia and coloading of     warmed intravenous fluid might reduce perioperative hypothermia and shivering in women     undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining     maternal normothermia increases newborn temperature and Apgar scores.   "
2224|NCT03256773|"     The purpose of this study is to learn about using the imaging to make images of the lungs and     nose with the long-term goal of the research leading to potential treatments and new     therapies for patients with cystic fibrosis.   "
2225|NCT03256760|"     Late-life depression is a significant public health concern, and effective interventions for     prevention and treatment are needed. Insomnia and inflammation are modifiable targets for     depression prevention, and this study is significant in using an experimental approach (i.e.,     inflammatory challenge) to probe acute inflammatory- and depression responses as a function     of insomnia, which will inform identification of molecular targets for pharmacologic     interventions, and improvement of insomnia treatments to prevent depression in older adults.      Project   "
2226|NCT03256747|"     In patients with type 2 diabetes mellitus (T2DM) chronic hyperglycemia is the main cause of     complications, promoting several micro and macrovascular damages. In order to understand     other mechanisms that could have an impact on the development of these diabetic     complications, the assessment of glycemic variability have been widely used. Glucose control     can be achieved with multiple interventions, including exercise training. Some individuals,     however, especially those with autonomic neuropathy, can have exercise intolerance. In this     context, physical therapy proposes neuromuscular electrical stimulation (NMES) as a     therapeutic that has been applied in research and clinical practice as an alternative to the     training of patients who cannot perform conventional exercise. In patients with T2DM, NMES     was shown to improve glycemic control and insulin sensitivity, but quality of these trials is     poor. In addition, the effects of NMES on glycemic variability of T2DM patients have not yet     been reported. The aim of this study is to evaluate the effects of NMES on glucose levels and     glucose variability in patients with T2DM.   "
2241|NCT03256552|"     The overall objective of this study was to assess the efficacy and safety of GP MDI relative     to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4     separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment     duration of 28 days.   "
2242|NCT03256539|"     This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting     improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive     impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light     therapy and a modified cognitive behavioral therapy for insomnia will be developed to address     24-hour patterns of sleep. We will then pilot test its feasibility and explore its     preliminary effects on improving sleep/napping and cognition in patients with MCI or mild     Alzheimer's disease.   "
8123|NCT03179553|"     This study will find out if analysing heartbeat in babies with brain injury, based on     standard clinical monitors, can inform treatment decisions and monitor stress levels in real     time   "
2227|NCT03256734|"     Unplanned hospital readmissions are associated with increases in morbidity, mortality, cost     and patient dissatisfaction,. Policymakers continue to seek effective policy solutions to     avoid readmissions in order to improve quality of care and reduce unnecessary expenditures,.     One attempt to reduce readmissions was implemented on June 1 2012, when the Specialist     Services Committee of British Columbia (a partnership of Doctors of BC and the Ministry of     Health) introduced the new G78717 fee code for physicians. The objective of the fee code     was to create a financial incentive for physicians to provide a point-of-care supplemental     discharge summary to patients and their primary care providers prior to discharge from     hospital. Initially, only urgent hospital admissions were eligible for this incentive payment     but on Nov 1 2015 the incentive was extended to include elective admissions as well. The     other eligibility criteria remained unchanged.      The effectiveness and cost-effectiveness of the fee code intervention is unknown. This study     will address important questions relevant to this policy intervention using rigorous methods     and empirical data.      This study will employ two methods for measuring changes in readmission risk. First, we will     use interrupted (multivariate) time series to measure whether there was a temporal change in     provincial readmission risk associated with the implementation of the new fee code.      We will complement the above analyses with a stronger design, comparing hospitalizations for     which the fee code was charged (intervention group) with a cohort of clinically similar     hospitalizations for which the fee code was not charged (control group). For this approach,     multivariate logistic regression will be the primary statistical method. Using this analytic     strategy, 30-day readmission risk between the intervention and control group will be measured     over time, adjusted for patient-, provider-, and hospitalization-level covariates.   "
2228|NCT03256721|"     Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor     activity in the patients with GC. The purpose of this study is to determine whether apatinib     plus chemotherapy drug can improve progression free survival compared with chemotherapy drug     in patients with metastatic the non-small cell lung cancer who failed one lines of     chemotherapy.   "
2229|NCT03256708|"     Prolardii contains intestinal bacteria, a yeast, a fructo-oligosaccharide and a plant extract     that can contribute to the intestinal comfort. This product could prevent the diarrhea which     sometimes occurs when the patient has to take antibiotics.      A total of 220 patients being prescribed antibiotics by general practitioners will be     included in the study and randomized into a Prolardii arm and a placebo arm.      The primary endpoint will be the overall frequency of diarrhea in the two treatment groups.     Acute diarrhea will be defined as the presence of three or more abnormally loose or watery     stools per day.   "
2233|NCT03256656|"     In previous studies, in which the perception threshold and / or sensory evoked potentials at     different points of the lower urinary tract were examined and measured by means of electrical     stimulation, a clear increase in the volume of the bladder and thus the urine excretion under     the stimulation could be observed. This observation is now to be investigated more closely in     a separate study, in order to strengthen the observation with further measured data and to     find possible physiological connections. A detectable influence of electrical stimulation in     the lower urinary tract on renal urine production would have a significant relevance both     therapeutically and for the neurophysiological understanding of interactions between the     lower and upper urinary tracts.   "
2234|NCT03256643|"     The purpose of this study is to determine whether exercise or exercise with enrichment is     beneficial in individuals who previously had a head injury. The enrichment will consist of a     cultural educational program that will include ethnic food, music, slides and a talk. A     series of tests that measure mental function and balance will be done before and after the     exercise or the exercise/enrichment program will be done to measure efficacy.   "
2235|NCT03256630|"     A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the     Presence or Absence of Aggressive Prostate Cancer   "
2236|NCT03256617|"     The focus of this proposal is to evaluate the feasibility of a cognitive reassurance training     program by examining changes in physical therapist low back pain beliefs and skills with     training and evaluating the quality with which physical therapists apply cognitive     reassurance to patients. The secondary focus is to examine the association between physical     therapist application of cognitive reassurance and short-term changes in patients' low back     pain beliefs and expectations.   "
2237|NCT03256604|"     In patients with clinical symptoms of respiratory infection, rapid identification of cases     requiring antibiotic therapy is crucial to avoid development of multiple resistant bacteria.     Identification of local acute-phase reactants can help assess the host's response to     bacterial infection at the injury site. Here, the investigators developed an affordable,     stable, feasible, and accurate diagnostic tool based on a locally produced protein with     specific binding affinity to polysaccharides. The investigators further evaluated the ability     of the novel test strip to rule out pneumonia.   "
2238|NCT03256591|"     Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths     and reduction in fresh stillbirths. HBB has successfully integrated some aspects of     simulation into an educational curriculum that teach the management of neonatal emergencies     in resource-constrained countries.      Simulation based training brings special advantages and may enhance HBB training. Critical     elements of simulation such as enhanced realism and post-event debriefing may carry potential     to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness     of this combined approach is limited.   "
2239|NCT03256578|"     This is a randomized trial to determine if a visible respiratory function monitor (RFM)     displaying realtime measurements of delivered inflations improves clinical providers ability     to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in     preterm infants after birth.   "
9860|NCT03157050|"     the aim of this study is to assess whether increased ferritin after intravenous iron therapy     will lead to increased prevalence of major depression among treated patients.   "
2244|NCT03256513|"     Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood     flow monitoring and blood pressure, and combining patient demographics and preoperative risk     factors to establish an applicable individual blood pressure controlling model. By comparing     with routine antihypertensive strategies through prospective randomized controlled trials ,     to provide the best perioperative blood pressure control standards and strategies for each     patient ,thus better ensuring the safety and efficacy of CEA .   "
2245|NCT03256500|"     Delirium is induced by changes in cortical excitability and transcranial direct current     stimulation (tDCS), by using weak electrical fields, can modulate cortical excitability and     spontaneous firing activities in the stimulated region by shifting the resting membrane. One     half of the subjects will receive stimulation via tDCS and the other half will receive sham     tDCS for 20 minutes per day, 5 days per week, for 1 week. Symptoms will be monitored using     the Confusion Assessment Method.   "
2246|NCT03256487|"     This study evaluates intravenous (IV) buprenorphine versus IV morphine for the management of     severe, acute pain among emergency department (ED) patients. ED patients with severe pain     will be randomized in equal proportion to receive IV buprenorphine or IV morphine.   "
2247|NCT03256474|"     Retrospective cohort analysis of children hospitalized for pneumonia comparing disease     severity on admission, clinical course, treatment and outcomes and prospective telephone     based Follow-Up assessement.   "
2248|NCT03256461|"     Serum lactate level is depended on the balance between lactate production and clearance. It     is seen as a sensitive indicator reflecting not only the low systemic perfusion but     microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of     impaired mitochondrial oxidation). 2016 Surviving Sepsis Campaign guideline stated We     suggest guiding resuscitation to normalize lactate in patients with elevated lactate levels     as a marker of tissue hypoperfusion, with weak recommendation and low quality of evidence.     Several trials which evaluated the resuscitation strategy included lactate clearance as a     target while based on 2.0 diagnostic criteria for sepsis, finally showed conflicting results.     The aim of this study is to explore the feasibility of lactate clearance guide resuscitation     in sepsis that defined by The Third International Consensus Definitions for Sepsis and Septic     shock through multi-center, central-randomization clinical trial.   "
2259|NCT03256305|"     This is a multicenter, randomized trial aims to reveal the efficacy and safety of Repetitive     transcranial magnetic stimulation (rTMS) individualized therapy based on the 'emotional loop     destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from     three centers and randomized with a 1:1 ratio to receive Personalized rTMS treatment or     traditional rTMS treatment in addition to routine antidepressant treatments.The data of     neuropsychological tests and MRI will be collected at 0, 2，4 and 8 weeks after the     commencement of the treatment.   "
2299|NCT03255785|"     Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular     micro-bypass stent and one suprachoroidal stent   "
2249|NCT03256435|"     Innovative and novel HIV prevention interventions are urgently needed for African American     (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular.     HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a     daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk     individuals. Although acceptability studies have demonstrated high interested in PrEP in the     US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to     settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention     in PrEP care in real world settings are likely more complex, since payment for PrEP can be a     substantial financial burden.      The ADAPT_ITT approach (an approach to adapting behavioral interventions to new populations:     Assessment, Decision, Administration, Production, Topical Experts - Integration, Training,     Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP)     intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and     focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the     country. This study will include formative research to understand the cultural and social     contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed     intervention. Results from these qualitative interviews will inform the study intervention     which will be tested and refined in a dynamic open pilot evaluation.   "
2250|NCT03256422|"     The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups,     evaluating at W48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a     week versus continuous therapy, in HIV infected patients with controlled viral load for at     least 12 months and stable antiretroviral treatment since 4 months.   "
2251|NCT03256409|"     The aim of the study was to compare the surface roughness (Ra) of the implant retained     mandibular bar overdenture (BOD) and the implant retained mandibular ball joint overdenture     (BJOD) in jaw and its relation with the adhesion of molds and yeasts and mesophyll aerobe, in     time 30 to 180 days in mouth. Five systems titanium bar CARES® and synOcta® Straumann® Dental     Implant System, Holding AG Inc., Basel, Switzerland (BOD); and five systems joint ball     Klockner® Implant System; Soadco Inc., Escaldes-Engordany; Andorra (BJOD), were used in two     parallel groups of five participants, in an essay to simple blind person. To 30 to 180 days     they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo     Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml).      The Ra:um (the 30th and 180th): BOD, 0.965 - 1.351; BJOD, 1.325 - 2.384. Adhesion: molds and     yeasts, BOD, 2.6 x 102 and 4.6 x 103; BJOD, 3.0 x 102 and 5.3 x 104. Adhesion: mesophyll     aerobe, BOD, 3.8 x 106 and 5.8 x 106; BJOD, 4.3 x 106 and 7.1 x 107. The BOD and BJOD,     present different Ra (P < 0.05) to 30 to 180 days. To 30 days (P = 0.489) differences do not     exist as regards the adhesion of molds and yeasts and mesophyll aerobe between both     overdentures. To 180 days (P = 0.723) differences exist as regards the adhesion of mold and     yeast and mesophyll aerobe, being major in BJOD.   "
2252|NCT03256396|"     The creation of pneumoperitoneum during laparoscopic surgery can have significant effects on     the respiratory system including decreased respiratory system compliance, decreased vital     capacity and functional residual capacity and atelectasis formation. Intraoperative     mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an     important role in respiratory management during laparoscopic surgery. The aim of this study     is to determine whether setting of PEEP guided by measurement of pleural pressure would     improve oxygenation and respiratory system compliance during laparoscopic surgery.   "
2253|NCT03256383|"     This study is to supplement our internal data that demonstrates the continued performance of     capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra     (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II     instrument in development.   "
2254|NCT03256370|"     Compare the HMO composition in breast milk of infants with allergic manifestation (atopic     dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic     mother and healthy infants with non-allergic mother.   "
2255|NCT03256357|"     A randomized, controlled, and evaluator-blinded trail will be carried out comparing CIMT with     or without AOT on sensorimotor outcome in children with unilateral CP aged 5 to 12 years.     Additionally the potential role of neurological factors, including the anatomical     characterization of the brain lesion, structural/functional connectivity and cortical     reorganization, on treatment response will be investigated.   "
2256|NCT03256344|"     Up to 36 subjects will be enrolled in this study. The locations of the study will be in the     United States, Australia, Europe and Switzerland.      The goal of this study is to evaluate the safety of intrahepatic injection (directly into the     liver) of talimogene laherparepvec in combination with intravenously administered     atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver     metastases.   "
2257|NCT03256331|"     This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study     to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate     safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced     refractory solid tumors. Dose escalation during the study will be made based on dose-limiting     toxicity (DLT).   "
2258|NCT03256318|"     Ten year longitudinal survey following children who have participated in CKRI Sports and     Recreation from a young age (5 to 8), and the parents of children who have participated in     CKRI Sports and Recreation at a young age (5 to 8). These children will be followed for 10     years with surveys every 6 months, whether they are currently participating in sports and     recreation activities or not.      The purpose of this longitudinal study is to examine the effects of early participation in     organized sports and recreation activities (S&R) on self-reported health and health-related     quality of life of children and youth (C&Y) with disabilities and their parent-reported     social participation. This project will examine child and parent reported differences     between:        1. C&Y who participate in CKRI S&R and those who have discontinued participation in CKRI          S&R programs        2. C&Y who participate in sports vs. those who participate in recreation, and        3. C&Y who participate in CKRI S&R and normative data on C&Y with disabilities and those          without disabilities.   "
2370|NCT03254862|"     The main aim of this study is to investigate the effect of patterned distribution stimulation     compared to conventional stimulation in reducing muscle fatigue during functional electrical     stimulation (FES) following spinal cord injury (SCI).   "
2261|NCT03256279|"     Objective: to compare the changes of the mechanical properties measured by tensile test and     three point bending test of two NiTi archwires (heat-activated and superelastic); when     exposed to the oral conditions during the first three months of orthodontic treatment and to     evaluated their clinical efficacy in lower arch crowding resolution in the anterior     mandibular arch.      Methods: Randomized clinical trial in 54 orthodontic patients with moderate crowding. They     are going to be randomly assigned in to two intervention groups, each group with 27 patients.     One group are going to be treated with heat-activated NiTi archwires and the other group with     superelastic NiTi archwires. The patients are going to be followed up for three months and     cast models will be taken every month. Measures of anterior lower arch crowding resolution     are going to be taken by previously-calibrated operators. Six archwires of each group will be     chosen at random and will have tensile test and three-point bending test and the mechanical     properties are going to measure before and after its clinical use. The outcomes are going to     be determined and compared between groups, with correspondent statistical test and the     results are going to be analyzed.   "
2262|NCT03256266|"     The study evaluates the effect of nutrient antigens or therapeutic agents on human small     intestinal organoids.   "
2263|NCT03256253|"     The proposed protocol is an 8 week open label outpatient pilot trial of the safety and     efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary     objective of the study is to determine the efficacy of pregabalin in promoting alcohol     abstinence among individuals with an alcohol use disorder.   "
2264|NCT03256240|"     This study proposes a randomized prospective study comparing the Kono-S anastomosis to the     standard side-to-side anastomosis.This will be a multi-center randomized prospective trial.     Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized     to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.   "
2265|NCT03256227|"     Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in     clinically significant symptom relief for many. Yet, adherence to this treatment (i.e.,     session attendance and homework compliance), which is vital to ensuring recovery, can be     poor. This project will test the effectiveness of improving family support for PE as a tool     to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact     Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite     congressional legislation and national mandates within VA/DoD for family involvement in PTSD     care, there remains no proven strategies for how to routinely include family in traditional     individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a     model of family engagement that can be translated to other problems faced by Veterans,     including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain     management, contributing to a broader evolution towards evidence-based, family-inclusive     care.   "
2266|NCT03256214|"     Seventy-one patients in intensive care were randomized for initial treatment with open     suction systems or closed suction systems in a cross-over design. Pulmonary and     cardiovascular physiology was assessed immediately before and after three 10-second     aspirations per suction. Were analyzed the effect of each suction system on physiologic     parameters while adjusting for their respective values prior to suction.   "
2267|NCT03256201|"     This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for     pancreatic or related cancers are randomized to dietary counseling and home exercise, either     with or without individualized resistance training in order to determine if resistance     improves outcomes.   "
2268|NCT03256188|"     This study tested the feasibility of interrupting prolonged sitting with 10, 3-minute     activity breaks in elementary school classrooms. Three elementary schools in Southeast     Michigan (20 teachers, 500 students) participated in this study.   "
2269|NCT03256175|"     Elective percutaneous coronary intervention (PCI) is often associated with myocardial     necrosis evidenced by peri-procedural troponin release. This is a surrogate for subsequent     cardiovascular events. There is no study on the effect of peri-PCI oxygenation in in     myocardial protection and cardiopulmonary fitness outcome. Patients with higher baseline     cardiopulmonary fitness will have lower mortality.      This study is to assess the utility of oxygen to reduce ischaemia in patients with     significant stable coronary artery disease scheduled for elective PCI. The secondary     objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness     and autonomic response.   "
2270|NCT03256162|"     Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an     adjunctive therapy for depression. The main purpose of the pilot study is to assess trial     processes to help inform a future definitive trial.   "
2271|NCT03256149|"     Few existing data currently indicates that anti-inflammatory drugs could help diminish the     local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an     anterior surgical approach to the spine. This study aims to evaluate the effect of high dose     of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a     cervical spine surgery through an anterior approach will be randomized to a treatment group     receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline.     Outcome will be measured with dysphagia scales, modified barium swallow and     rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve     neurological condition, pain and fusion rate.   "
2272|NCT03256136|"     This research study is studying a drug intervention as a possible treatment for lung cancer.      The drugs involved in this study are:        -  Nivolumab        -  Carboplatin        -  Pemetrexed        -  Ipilimumab   "
2273|NCT03256123|"     Based on recent nutrition survey (SEANUTS Malaysia) on a total of 3542 Malaysian Children     aged between 6 months to 12 years old, 4.4% of the children had vitamin A deficiency. Rural     areas recorded a higher prevalence of vitamin A deficiency (6.4%) compared with urban areas     (3.8%). Besides, prevalence of iron deficiency due to low ferritin concentrations is 4.4% and     anaemia based on low haemoglobin concentrations is 6.6%. It is proposed that a red palm oil     intervention programme to be conducted in alliance with RMT in Malaysia to enhance the     Vitamin A status of school children in underprivileged community in Malaysia.   "
2274|NCT03256110|"     This mixed-methods study is culturally tailoring and evaluating a communication intervention     to increase the frequency and quality of advance care planning with diverse American Indian     and Alaska Native adults with serious, life-limiting illness in primary care at two sites.   "
2275|NCT03256097|"     The study aims to compare two different cochlear implant sound processing strategies. All the     participants will start off with a sound processing strategy called the XDP (extended     performance). At the 3 month stage, half of the participants would randomly be selected and     offered a sound processing strategy called the Voice Guard. Following that, the sound     processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th     month of cochlear implant use.   "
2276|NCT03256084|"     Prospective research of circulating tumor cells as markers of progression risk in colorectal     cancer.   "
2277|NCT03256071|"     The purpose of this prospective, open-label, randomized multicenter study is to evaluate the     safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY     as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia     (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).   "
2278|NCT03256058|"     This is a randomized controlled trial designed to research the effects of different     tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty,     and to guide early postoperative recovery.   "
2279|NCT03256045|"     This phase II trial studies how well panobinostat, carfilzomib and dexamethasone work in     treating patients with multiple myeloma that has come back or does not respond to treatment.     Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Drugs used in chemotherapy, such as carfilzomib and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Using multiple myeloma cells from     patients' blood samples, the researchers will do laboratory tests to look at how well each of     the drugs, alone and in different combinations, kill multiple myeloma cells. If the     laboratory tests work well, they may be used in the future to help plan treatment for future     patients.   "
2280|NCT03256032|"     Patient's sublingual temperature was measured postoperatively on entry to the recovery room.   "
2281|NCT03256019|"     This is a clinical study based on analysis of video-clip data of CPR and clinical data for     out of hospital cardiac arrest patients between 2011-2015. Aim of study is to compare the ETI     performance and CPR outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL)     users.   "
2282|NCT03256006|"     To study per and post effort variations of inflammatory biological markers during a 100 miles   "
2284|NCT03255980|"     To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation     dermatitis in breast and head & neck cancer patients.   "
2365|NCT03254927|"     This is a study to determine the clinical benefit (how well the drug works), safety and     tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with     advanced head and neck squamous cell carcinoma who have previously received cetuximab and     progressed.   "
31801|NCT02869490|"     Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer   "
2285|NCT03255967|"     Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our     public health. While many persons with dementia are cared for by friends and family in the     community with the assistance of home healthcare, most home healthcare clinicians and     agencies are ill prepared to care for this population and therefore have difficulty assisting     patients and caregivers in maintaining quality of life leading to adverse patient outcomes,     increased caregiver stress and burnout, and healthcare utilization. This study will therefore     utilize a cluster randomized controlled design at 3 study sites to examine the ability of a     multi-component evidence-based practice primary palliative care quality improvement program     for home healthcare registered nurses, occupational therapists and physical therapists to     improve the quality of life and reduce healthcare utilization for persons with dementia and     their informal caregiver.   "
2286|NCT03255954|"     Interpersonal Counseling (IPC) is brief, structured modification of Interpersonal     Psychotherapy (IPT). IPC was developed as a brief triage manual to treat depression in     primary care, family practice and non-mental health programs, and work and educational     settings. College and university students are at the age where first episodes of depression,     bipolar disorder, or psychosis may occur. IPC is relevant for this population as many     university students' distress are related to profound life changes, role transitions,     loneliness and social/cultural isolation, which are focuses of treatment in IPC. While there     is considerable evidence for the efficacy of IPT and IPC, this adaptation for university     students has not yet been studied. The investigators propose to administer IPC to across     several college campuses, and to recruit 20 participants at each counseling center.     Participants will receive 3-6 one-hour therapy sessions, and will complete self-report     measures of depression, psychosocial functioning, college adjustment, and treatment     satisfaction. IPC has the potential to reduce depressive symptoms and prevent presenting     symptoms from worsening. For these reasons, developing and testing a brief, yet comprehensive     psychosocial intervention for distressed college students has tremendous importance.   "
2287|NCT03255941|"     This is a randomized controlled trial comparing lay Lady Health Workers with Lady Health     Visitors on quantitative measures of safety and effectiveness of Depo Provera and Sayana     Press provision in a clinic setting. This comparative trial will test the non-inferiority     hypothesis that Lady Health Workers are just as competent as clinically-trained Lady Health     Visitors in screening and counseling first-time injectable users. These first time users will     also be randomly assigned to receive intramuscular or subcutaneous injections of DMPA.   "
2288|NCT03255928|"     Consenting patients with end-stage heart failure that are implanted with/candidates for     implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous     microaxial pumps (Impella), extracorporeal membrane oxygenator (ECMO), Ventricular Assist     Device (VAD) will be enrolled in the study.      Aim of the study is to evaluate the patients' haemostatic and coagulation profile, how it     interacts with the support device as well as the effect of antithrombotic drugs. From these     data, it will be possible to derive the mechanisms triggering post-implant     thromboembolic/hemorrhagic complications and to identify potential therapeutic targets.   "
2321|NCT03255499|"     This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive     abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise     regimen, based on high-intensity training, and a cognitive training component. The design     will contrast the intervention with an active control group, matched for expectancy effects.   "
2289|NCT03255915|"     Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by     randomization to order with 5 participants per study arm. All participants will sequentially     receive both study products for 28-days with at least a 2-week washout period between     products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR     during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC     pod-IVR during Stage 3. During Stages 2 & 3 participants will also complete brief phone     surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs)     regarding perceptibility and acceptability. If willing, participants' male sexual partners     will be invited to complete IDIs as well.   "
2290|NCT03255902|"     The purpose of the proposed study, Family Routines - Healthy Families, is to examine the     feasibility and acceptability of a parenting/family routine intervention program for parents     of young children, ages 2-5, with type 1 diabetes.   "
2291|NCT03255889|"     The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the     form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a     single center study, and the recruitment is expected to happen over a 1-2- month's period.   "
2292|NCT03255876|"     Results from a large number of studies in humans have shown that diets rich in foods that     give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found     in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood     glucose spikes following a carbohydrate-rich meal, through partial inhibition of the main     enzymes of carbohydrate digestion and reduction in glucose and fructose transport from the     gut after digestion and by enhancing the insulin action after glucose reaches the     bloodstream.      This study is designed to determine whether polyphenols, as normally and naturally present in     food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose     levels after its consumption, and hence lower its glycaemic index, and if this effect is     mediated through effects on insulin and other hormones. The study is designed as an acute,     double-blind, randomised, placebo-controlled crossover trial in 24 healthy subjects with     normal glycaemic response to white bread. Participants will be asked to consume either white     bread with pomegranate juice enriched with extracts from grape seeds and apple peels or white     bread with placebo drink. The effects on plasma glucose levels, levels of hormones and other     biomarkers involved in postprandial response will be determined over 3 hours after the     consumption.   "
2303|NCT03255733|"     This study evaluates the effectiveness, safety and patient tolerance for the use of Intense     Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal     tissue pain reduction began in July 2015 and was completed in March 2017. The More     Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic     lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on     subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by     the Principal Investigator. Patients were followed for up to 6 months after the first     treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided     feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy     at each visit and via phone follow-up at 26 weeks after the first treatment.   "
2304|NCT03255720|"     Diffusion Tensor imaging of white matter degeneration in Alzheimer disease   "
2293|NCT03255863|"     Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with     a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic     Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main     aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to     the Health Belief Model, patient will participate in TPE if they perceive their disease as a     serious threat (with possible serious complications), but which can be controlled however,     and that TPE is efficient and represents little burden.      Secondary aims are as follows:        1. To test whether the way TPE is presented to patients impact patients' decision to uptake          TPE. The way TPE is presented comprises the time between diagnosis and the proposal of          TPE, whether patient is a remission or crisis period in the disease, the time between          the proposal and the next TPE session, and what is said by healthcare professionals to          present TPE.        2. To test whether healthcare professionals' empathy impact patients' decision to          participate in TPE        3. To test whether patients' intention to participate in TPE will predict their actual          participation.      The ultimate goal of the study is to identify patients whose beliefs will not favor     participation in TPE in order to accompany those patients more carefully. Best practices will     be proposed according the results.   "
2294|NCT03255850|"     This study aims to examine the psychological well-being and QoL of Hong Kong Chinese     adolescents with CHD by        -  comparing the self-esteem level, depressive symptoms, and quality of life of adolescents          suffering from CHD with healthy norms and cancer survivors.        -  identifying possible factors affecting the quality of life of adolescents suffering from          CHD.   "
2295|NCT03255837|"     This study will involve an experiment in individuals with Autism Spectrum Disorder (ASD)     comparing their performance on a working memory task before, during and after non-invasive     brain stimulation (tDCS) compared to a control group in a 3x3 factorial design. How the     stimulation affects performance on the task will be assessed, along with the impact of the     intervention on the individuals.   "
2296|NCT03255824|"     Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar     surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and     3) no significant hemodynamic or respiratory changes when compared to a sedation combination     of midazolam, fentanyl and propofol for sedation during third molar surgery.   "
2297|NCT03255811|"     At present, apatinib was approved for the treatment of advanced gastric cancer after     second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of     medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small     sample exploratory research, in the conventional chemotherapy after the onset, with APA for     Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line     advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the     feasibility of anti generate small molecule targeted therapy in advanced gastric cancer     vascular pattern.   "
2298|NCT03255798|"     Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation     iStents and one iStent Supra   "
2300|NCT03255772|"     Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG)     analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic     option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux     system will be compared with stress testing methods as well as the results of cardiac     catheterization to identify patients with myocardial ischemia.      This is a prospective observational single-blinded convenience pilot study of 100 patients     placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital     and Medical Center (Detroit, MI).      Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of     adverse cardiac events.   "
2301|NCT03255759|"     A number of rapid panel-based molecular assays for direct organism identification and     resistance characterization in positive blood culture bottles are now commercially available.     They have been shown to improve accuracy and decrease the time-to-result, allowing targeted     treatment in hospitalized patients with bacteraemia, in high-income countries (HICs).     However, these molecular assays are add-on tests performed in addition to conventional     testing, increasing the complexity of diagnostic algorithms and costs of patient care.     Conventional organism identification includes performing a Gram stain, biochemical     identification and phenotypic drug susceptibility testing. The FilmArray Blood Culture     Identification (BioFire, USA) is an example of a rapid panel-based molecular assay that     combines nesting and multiplexing of PCR (nested multiplex PCR) to detect multiple pathogens     simultaneously. There are limited data on how such tests impact patient management, health     care costs and how they can better be incorporated into diagnostic algorithms.      The aim of this study is to assess the added value and acceptability of a multiplexed     molecular diagnostic assay in the identification of pathogens in patients presenting with     bacteremia at hospitals in LMICs, and to assess health care providers' satisfaction with the     assay.   "
2302|NCT03255746|"     Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases     worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension.     Observational and experimental evidence favoring a causal relation between insufficient sleep     and hypertension are particularly compelling - sleeping 6 hours or less per night is     associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment     is largely voluntary, sleep deficiency may be corrected and the detrimental health     consequences potentially reversed.      In this study the investigators aim to investigate the effects of 8 weeks of sleep     enhancement/extension vs health education in prehypertensive and stage 1 hypertensive     subjects who report habitual short sleep (=6.5 hours/night).   "
2354|NCT03255070|"     This is a 2-part, Phase 1, open-label study. Phase 1a of this study is designed to determine     the recommended Phase 2 dose (RP2D) in subjects with advanced cancer whose HER2 test results     are in situ hybridization (ISH) positive or immunohistochemistry (IHC) 3+ and Phase 1b is     designed to assess anticancer activity and safety in 2 advanced breast cancer expansion     cohorts: 1) for tumors that test as HER2 ISH positive or IHC3+ and, 2) for tumors that test     as HER2 ISH negative with IHC 2+.   "
31802|NCT02869477|"     Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer   "
2305|NCT03255707|"     Amblyopia is a unilateral or, infrequently, a bilateral reduction of best corrected visual     acuity which cannot be attributed to coexisting eye or visual pathway disease. Amblyopia can     be due to eye-crossing occurring in early childhood or due to error of refraction whether a     high difference between the two eyes or very high bilateral refractive errors.Another cause     could be visual deprivation like the presence of congenital cataract.      The prevalence of amblyopia worldwide is approximately 1%-5% .In Egypt, a study that was held     in Upper Egypt, found that the prevalence of amblyopia was 1.49%, which is higher in rural     areas than in urban areas.      Several modalities of treatment for amblyopia are available, yet occlusion treatment is the     gold standard involving covering the good eye with a patch for a prescribed period of time     ranging from 10 minutes daily to all waking hours. However, its effectiveness decreases in     older children and adults.      Disadvantages include prolonged treatment leading to poor compliance, patching related     distress, relationship strain and stigma. In extreme cases, non-compliance with patching     results in a costly hospital admission to supervise the patching treatment. In addition,     wearing a patch eliminates any advantage of binocularity. Not to mention that not all     patients respond to patching and of those who do, many have residual amblyopia after     treatment is stopped regardless of compliance. More importantly, binocular vision is not     automatically restored once the vision in the amblyopic eye has been improved. In fact, once     the patch is removed after therapy, the amblyopic eye could be suppressed by the better     seeing eye and can lose some of the gains achieved as a result of therapy.      Another modality of treatment is atropine eye drops and optical penalisation which are     usually secondary treatments to failed patching but carrying the same disadvantages as the     ordinary patching.      Advances in amblyopia treatment include dichoptic training, perceptual learning, and video     gaming. These depend on the fact that the adult brain has been shown to be much more plastic     than it was once believed to be and hence have the advantage of expanding the age of response     in adults.      Perceptual learning approaches have the advantage of being a dichoptic (binocular treatment     using both eyes) approach which is independent of age and type of amblyopia.      A step further to conventional treatment is the use of a home-based approach allowing remote     internet monitoring of treatment between office visits and hence better compliance. In     addition a video game version of the treatment is developed to make it more enjoyable for     improving compliance.      Our goal is to compare the outcome between the gold standard occlusion therapy and one of the     dichoptic treatments.   "
2306|NCT03255694|"     After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human     growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical     treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The     long-term efficacy and safety of the investigational product are evaluated, which can provide     more scientific and reliable medication guidance information for clinical diagnosis and     treatment.   "
2307|NCT03255681|"     The purpose of the study is to determine the efficacy of platelet-rich plasma (PRP) as a     cosmetic facial injectable filler to treat tear troughs deformities secondary to volume loss     and skin laxity in the infra-orbital region. Patients will receive injections of PRP on the     left side, and PRP with A VectraH1 3D camera will be used to quantify the volume of the     infra-orbital region before treatment, at 1, 3, 6 and 12 months post treatment. The objective     is to quantify the amount of volume gained in the region as well as to assess duration of     volumization after PRP treatment and also if volumization results are permanent.   "
2308|NCT03255668|"     Subjects who are recruited in this study are LLA patient, who are treated for routine control     to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion     criteria.   "
2322|NCT03255486|"     Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer   "
2323|NCT03255473|"     Compare hearing outcomes between treatment with dexamethasone versus prednisone in     participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing     loss).   "
4061|NCT03232697|"     The aim of the study is to validate a french version of the 5 minutes version of the Montreal     Cognitive Assessment as compared to the french full version of this test.   "
2309|NCT03255655|"     Double-blinded feasibility study for the treatment of pain related to chronic plantar     fasciitis. A total 37 patients (27 treated and 12 control/sham treated) received 2     treatments, 2 weeks apart on subcutaneous plantar fascia musculoskeletal tissue along with     Standard of Care treatments as prescribed by the Principal Investigator. Patients were     followed for up to 6 months after the first treatment receiving a physical exam at each     follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported     Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up     at 26 weeks after the first treatment.   "
2310|NCT03255642|"     This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and     polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.   "
2311|NCT03255629|"     To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia     occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and     exercise.   "
2312|NCT03255616|"     The aim is to disentangle the supraspinal sensorimotor representation and its potential     cortical reorganization of different thoraco-lumbar motion segments by using a novel     computer-controlled, MR compatible pneumatic spinal indentation device (pneuSPID).   "
2313|NCT03255603|"     The rates of chronic diseases like obesity, diabetes, and heart disease are rising across the     world. This is especially true in industrialized countries like Canada and the USA. Even     though there are many possible causes for these increases. One prominent cause is our refined     diet, which greatly lacks dietary fiber. This 'fiber gap' between the amount of fiber     actually eaten and the amount that should be eaten is likely promoting these diseases.      It is known that a high fiber diet can benefit health and the health of the gut bacteria. It     is also know that these gut microbes can help cause and prevent diseases. When fiber is     eaten, it gets broken down not by us, but by our gut microbes. During this process     by-products called short-chain fatty acids (SCFA) are made. These SCFA have been shown to     promote health. Therefore, it is thought that fiber changes the gut microbes to produce more     SCFA, which may improve overall health.      In order to aid our microbes and improve our health we need to find ways to reduce this     'fiber gap'. One possibility is to add fiber to our refined diet. To do so we must first     learn how different fibers perform in our gut. This includes how our gut tolerates increasing     amounts of fiber, and how our microbes respond. The purpose of this study is to learn how     different types of resistant starch perform in our gut, including gastrointestinal tolerance.     By doing so we will determine the ideal dose and type of these fibers to use in future     studies.   "
2314|NCT03255590|"     This study plans to determine whether training with concurrent non-invasive brain stimulation     can change abnormal flexion synergy in chronic stroke patients.   "
2315|NCT03255577|"     This study is being done to help the investigators determine how accurate the sentinel lymph     node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant     chemotherapy in patients presenting with locally advanced breast cancer.   "
2355|NCT03255057|"     This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow     extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive     mechanical ventilation for patients who require respiratory support due to an acute     exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the     Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation     compared to COPD patients treated with standard-of-care mechanical ventilation alone.     Eligible patients will be randomized to receive lung support with either the Hemolung RAS     plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation     alone.   "
2316|NCT03255564|"     Infants born with heart problems are at risk of developing gut disease due to reduced blood     flow to the intestines which can result in poor weight gain, surgery and even death. At     present, doctors are often unaware of any gut problems until clinical symptoms present (poor     feed tolerance, blood stained stools or bloated stomach) which is often too late to prevent     gut damage.      Earlier diagnosis of gut disease may now be possible; calprotectin is produced when the gut     is inflamed and can be found in faeces and blood. Calprotectin levels have been shown to be a     reliable marker in diagnosing gut disease in premature infants. To date, calprotectin levels     have not been monitored in infants with cardiac defects, who like premature infants are at     high risk of gut disease but the cause of gut disease is different to that seen in premature     infants and therefore requires specific monitoring.      This study will implement a high risk feeding protocol which has been adapted from current     feeding practices from the United States; the aim being to promote weight gain without     increasing the risk of gut inflammation. Furthermore, the study will validate whether faecal     calprotectin is a useful non-invasive marker in identifying gut disease in infants with     cardiac defects. Currently, infants are diagnosed with necrotising enterocolitis by an     abdominal X-ray (current 'Gold Standard'); infants who have a positive diagnosis will have     faecal calprotectin levels cross-checked. From this data, cut-off values will be established     which will provide data to diagnose necrotising enterocolitis eliminating the need for X-rays     (radiation).      Secondly, faecal calprotectin levels will be measured at strategic time points (longitudinal     data) linked to increased risk of gut damage (following cardiac surgery and feeding) which     will then be cross-checked against infants that developed NEC to identify whether high risk     infants had raised calprotectin levels earlier.   "
2317|NCT03255551|"     Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension   "
2318|NCT03255538|"     Despite DFM being a widely-used technique and the empirical grounding regarding the     importance of the pressure applied, there is no study characterizing the pressure applied     during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known     how the amount of pressure applied may influence pain mechanisms or function in the     symptomatic patellar tendon. Having this, our objective is to characterize the pressure     applied during deep friction massage and evaluate the immediate effects of different     pressures applied during deep friction massage in the time until analgesia as well as in     function, in patellar tendinopathy.   "
2319|NCT03255525|"     Despite DFM being a widely-used technique and the empirical grounding regarding the     importance of the pressure applied, there is no study characterizing the pressure applied     during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known     how the amount of pressure applied may influence pain mechanisms and, consequently how it     affects the time needed promote an analgesic response.      Having this, our general objective is to establish a dose-response relationship between the     pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar     tendon.   "
2320|NCT03255512|"     This study is intended to investigate the pharmacodynamic drug-drug interaction as well as     the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable     coronary artery disease.   "
2336|NCT03255304|"     The current proposal aims to investigate implicit and explicit priming paradigms for changing     cue-dependent and goal-directed nutritional behavior.   "
2324|NCT03255460|"     Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central     nervous system. In MS, various loss of strength, balance and gait disturbances arise in the     central nervous system due to sensory and/or motor neuron degeneration. These disorders lead     to limitations in individual activities and participation.      Fatigue is as reported one of the most common first three symptoms among patients with MS and     affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental     energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind.     The most important effect of fatigue is that individuals reduce their physical activity     levels. This can lead to the inactivity-related secondary problems being added to the     findings of the disease. So the physical capacities of individuals may gradually decrease.      In the literature, there are many studies showing that the level of physical activity of     individuals with MS is lower than in healthy individuals. When the investigators analyze the     studies that investigate the relation between fatigue and physical activity levels, it is     seen that there is the single study about this subject in the literature.      As a result, additional studies are needed to investigate the level of physical activity and     the factors affecting it in individuals with MS. Therefore, the investigators planned this     study to investigate the relationship between fatigue and physical activity levels in     patients with MS.   "
2325|NCT03255447|"     Autoimmune Membranous Nephropathy is now understood to be a condition caused by the immune     system although the exact mechanism is not completely known. This study aims to remove the     offending part of the immune system using immunoadsorption to not only treat the disease but     also use the opportunity to better understand the mechanism of disease. This will allow more     targeted treatment in the future with less complications and side effects.   "
2327|NCT03255421|"     This study evaluate the feasibility and the accuracy of an emptying cystometry in order to     simplify the manometric follow-up of overactive detrusor in neurological patients under     anticholinergic or botulinum toxin injections.   "
2328|NCT03255408|"     A prospective double blind, placebo-controlled, randomized cross-over trial to evaluate the     effect of lowering cerebral blood flow on the ventilatory chemoreflexes (acute hypoxic and     hypercapnic ventilatory responses).   "
2356|NCT03255044|"     There is a controversy whether statins are beneficial in patients with heart failure or not.     Trials in which lipophilic statins have been used revealed positive results, unlike major     studies where hydrophilic statins were administered. This trial is designed to compare the     effects of lipophilic versus hydrophilic statin use in patients with heart failure.   "
10941|NCT03142698|"     Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to     the reference method (liver biopsy) in quantification of hepatic steatosis   "
2329|NCT03255395|"     AIM: To provide initial information on the efficacy (pain reduction) and safety of focused     ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic     pain.      PARTICIPANTS: The study will include 10 amputees (men/women age >18 years old) with chronic     (>3 months) phantom/residual limb pain (NPS ≥ 4).      DESIGN: Patients potentially qualifying for the study will be offered an Informed Consent to     sign prior to further evaluation. Those who accept will sign the informed consent, complete     study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically,     a complete medical history will be obtained to determine the patient's general health status,     current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain     scores will be established. If not performed within six months prior to the evaluation, a     contrast MRI of the stump will be performed. Patients not meeting the study criteria will be     exited from the study as screen failures and not be included in analyses. All qualifying     patients will complete a baseline MRI exam on treatment day. Any patient not meeting study     criteria at Imaging will be exited as screen failures.      After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment.     These patients will then be followed for 6-months post-ExAblate treatment; the patients will     complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months     after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after     treatment to assess their pain status, their quality of life and safety. Data regarding     dosage and frequency of analgesic intake for the management of post amputation NP will be     collected. Relevant cost data will be collected in order to enable an assessment of the total     cost of the procedure.   "
2330|NCT03255382|"     The purpose of this study is to compare the efficacy and safety of subcutaneous (SC)     risankizumab and oral FUMADERM provided as study medication in subjects with moderate to     severe plaque psoriasis who are naïve to and candidates for systemic therapy.   "
2331|NCT03255369|"     The recent increase in the number of cases of congenital microcephaly observed in Brazil is a     reason of great concern. This increase occurred a few months after Zika virus (ZIKV) was     introduced in the country, which was associated with reports of pregnant women presenting     fever and rash illness during pregnancy. Thus, the hypothesis of a relationship between ZIKV     infection and microcephaly became plausible. However, studies on the pathophysiology of     maternal ZIKV infection, its consequences for the fetus, and the development of severe     encephalopathy are still needed. Knowledge about the natural history of vertical transmission     and its association with changes in fetal development in early life is still scarce. Studies     on factors which determine the severity and clinical evolution, such as inflammatory response     mechanisms, viral evolution, and development of serological tests to identify ZIKV infection,     are still needed. The Aedes aegypti is responsible for the transmission of various types of     viruses of interest to human health. Currently, it is primarily responsible for the     transmission of the dengue, chikungunya, and ZIKV in epidemic proportions. In addition, it is     not yet known whether there is an interaction between these viruses and whether the     interaction can determine the severity of the disease. The aim of this study is to evaluate     the natural history of ZIKV disease in two cohorts( pregnant women and children) starting     with pregnant women or newborns or evennursing mothers, identifying risk biomarkers, mapping     the anti-viral inflammatory response, evaluating the molecular evolution of the virus,which     areimportant to determine the mechanisms of vertical viral infection and verify children     neurodevelopment from birth to the end of 3rd year of life.   "
2332|NCT03255356|"     The purpose of this study is to evaluate prospectively ventilatory practices in the     perioperative cardiac surgery period.   "
2333|NCT03255343|"     Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to     conventional therapy inoperable liver cancers by in situ introduction of ImDendrim.      Trial Design:      An, open-labeled and unicenter study in women or men with primary hepatocellular cancer or     metastatic liver without standard therapeutic options for treatment including chemotherapy or     surgery.   "
2334|NCT03255330|"     Study of the effect of gabapentin used as a preemptive to the emergence and development     chronic neuropathic pain in patients after spinal cord trauma   "
25935|NCT02946216|"     The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA     samples in EGFR-wildtype NSCLC   "
2337|NCT03255291|"     Epidemiology seeks to improve public health by identifying risk factors for cancer and other     diseases and conveying that information to relevant audiences (e.g., physicians, the public).     The audience is presumed to understand and use that information to make appropriate decisions     about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can     affect the risk of multiple health outcomes, this information is seldom communicated to     people in a way that optimizes their understanding of the importance of engaging in a single     healthy behavior. Providing individuals with the ability to understand how a single behavior     (obtaining sufficient physical activity) could affect their risk of developing multiple     diseases could foster a more coherent and meaningful picture of the behavior's importance in     reducing health risks, increase motivation and intentions to engage in the behavior, and over     time improve public health.      The proposed study translates epidemiological data about five diseases that cause significant     morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes,     and stroke) into a visual display that conveys individualized risk estimates in a     comprehensible, meaningful, and useful way to diverse lay audiences.   "
2338|NCT03255278|"     The study is aimed to evaluate the safety and immunogenicity of the medicinal product     GamTBvac - a recombinant subunit vaccine against the tuberculosis. The study is designed as     a comparative placebo-controlled study with a two-fold increase of an applied dose among     healthy volunteers aged 18-49 years.   "
2363|NCT03254953|"     This study is a randomized controlled trial that compares 3 self-monitoring approaches for     weight loss. GoalTracker is a standalone, technology-based intervention using a commercial     smartphone app (MyFitnessPal) and email.      The investigators hypothesize that the group that delays diet tracking and receives     additional intervention components (weekly personalized feedback, skills training, and action     plans) will have greater weight loss at the end of the 12-week intervention and at 6-month     followup, compared to (a) an intervention group that simultaneously tracks weight and diet     for all 12 weeks and receives the same additional components, and (b) a control group that     tracks only diet.   "
2339|NCT03255265|"     Organ transplantation has become an effective therapy for patients with end-stage organ     failure at present. Rejection is still the most common cause of early dysfunction after organ     transplantation. A large number of experimental and clinical data are suggesting that the     formation of microchimer can successfully achieve donor-specific immune tolerance after     transplantation. The formation of microchimerism may be one of the long-term survival     mechanisms of transplantation, and the detection of microchimerism after transplantation can     effectively predict the rejection of grafts. Scientists from Stanford University in the     United States continued to report in 2014 and 2015 that using a new generation of     high-throughput sequencing technology (NGS) to detect the level of free DNA from donor in     blood plasma of recipients after cardiac and lung transplantation. The investigators found     the level of free DNA in donor significantly increased when acute or chronic rejection     happens, thus it may be used as a reflection of rejection or graft injury markers.      It has been reported that microchimerization and donor free DNA levels are associated with     rejection after organ transplantation, but these studies are mostly based on a small number     of cases and the results of which re qualitative and can not provide a specific     microchimerization rate due to limited detection techniques. Therefore, in order to clarify     the role of microchimerism and the level of cell-free DNA in donor in organ transplantation     tolerance, it is necessary to use a new generation of detection technology for multi-center     study with large samples.      Clinical trial was used to evaluate the clinical prediction and diagnostic value of     microchimerization rate and donor cfDNA for acute rejection after organ transplantation.      950 cases of organ transplantation, of which 600 cases of renal transplantation, 300 cases of     liver transplantation and 50 cases of lung transplantation.8 ml peripheral blood was     collected in 1 tubes with EDTA anticoagulation. The timing of the collection was as follows:     Patients with routine treatment after transplantation were preformed once every one weeks for     one months and then every 3 month until the one year. In case of acute rejection, the     additional blood was collected once on the day of diagnosis, and once after the treatment     remission. All the samples were detected for microchimerism and cfDNA.   "
2340|NCT03255252|"     Perspectives:        -  To set-up another clinical trial with this specific phenotype as the main stratification          factor. Therefore a more aggressive or a more specific systemic treatment (with or          without an immunomodulator) could be proposed to those selected patients in the field of          personalized medicine.        -  To evaluate the use of the smear as a surrogate non-invasive technique to biopsy for          immunomonitoring.        -  To use the CTC/PD-L1 assay as a liquid biopsy in future clinical trials for          stratification and monitoring of cancer patients undergoing immune checkpoint          treatments. This specific subset of CTCs might represent metastatic cells with a high          potential to escape T cell-mediated lysis and might therefore be the actual targets of          immunotherapy.   "
2341|NCT03255239|"     Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture     repair for ventral hernias less than 3 cm diameter   "
2342|NCT03255226|"     To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF     patients with volume overload   "
2343|NCT03255213|"     This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with     Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help     design future research studies about LMT in LOPD.   "
2344|NCT03255200|"     To gather data on the long-term safety of ReActiv8 and identify any residual risks by     reporting all Serious Adverse Device Effects as well as performance and health care     utilization through two years post-implant.   "
2345|NCT03255187|"     This study aims to evaluate whether dietary supplementation with fish oil can protect against     the cardiopulmonary alterations linked to air pollution   "
2346|NCT03255174|"     The objective of this study is to evaluate the safety and hemostatic effectiveness of     EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue     bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac)     surgery in pediatric population.   "
2347|NCT03255161|"     The purpose of this study is to test the effectiveness of a community health worker     intervention to expand access to hearing health care among older adults facing health     disparities.   "
2348|NCT03255148|"     In this study, the investigators will explore the influence of oxytocin administration on     several neurophysiological responses (EEG, skin conductance and heart rate) during rest.   "
2349|NCT03255135|"     Prostate cancer (PCa) is the most prevalent non cutaneous cancer in occidental countries. In     Brazil incidence was about sixty thousand new cases in 2016 and occupied second place as all     cancer mortality, just behind lung cancer. Literature shows than younger patients tend to     have more aggressive tumors rising cancer specific mortality scores. Main risk factors are     age, life style (sedentary, high meat and fat intake) and family history (gene inheritance).      Besides vast advances in precocious tumors detection, challenges remain in the definition of     the biological status of the tumor, which is highly variable and full of prognostic     implications. PCa heterogeneity is demonstrated by the uncertain natural history, varying     from indolent lesion to aggressive metastatic and fast progression cancer resistant to     conventional therapies. In an actual treatment scenario, prognostic identification is the     cornerstone of daily practice treatment considering the natural history variability cited     before and the discrepancy of long term slow growth (studies estimate eight to sixteen years     of tumor growth to achieve metastatic disease) to high grade aggressive cancer.      Considering all this background and taking in account the indolent evolution of low risk PCa     new therapies emerge with promising outcomes. High-Intensity Focused Ultrasound (HIFU) have     to be highlighted due to easy operation, good oncologic results and low complication profile.     The method is based on real-time imaging guided high intensity ultrasound (US) causing     overheat and cavitation in the focused tissue. Applied since 90's, mainly in German and     French groups, initially programmed to treat hole gland preserving only urinary sphincter and     bladder neck, showed recently some data on 1700 patients, 5 years biochemical recurrence free     survival of 80% and best results including morbidity profile in low risk, low prostate volume     and in the group with previous trans urethral prostate resection (TURP). This results are     very similar to other radical treatment options with median follow up of 8 years, cancer     specific survival 98% and metastasis free survival of 95% If local recurrence was identified     another HIFU ablation or even radical treatment achieved good results in local control with     acceptable morbidity profile.      Focal treatment is a new entity in PCa therapy. One randomized trial compared focal treatment     to active surveillance in 513 mans with PCa diagnosis. With a 24 month follow-up     progression-free ratios (28% x 58%) and positive control prostate biopsy ratios (14% x 49%)     were fairly superior in treatment group. This exiting novel data turns urological oncology     paths to the new era of minimally harmful therapy with targeted focused procedure. At our     knowledge there is no high evidence clinical trial comparing HIFU to active surveillance.      The objective of this study is to evaluate prospectively the initial experience with 50     patients submitted to HIFU therapy for low risk prostate cancer in Brazilian single center     considering the following aspects:      One year of treatment prostate biopsy positiveness; Biochemical recurrence free survival     using Phoenix and Stuttgart criteria in one year; Sexual function using IIEF-5 questionnaire     and the usage of 5-phosphodiesterase inhibitors (5-PDI); Urinary symptoms using EPIC and IPSS     questionnaires and free urinary flow; Quality of life based on SF-36 questionnaire     evaluation; Post procedure morbidity using Clavien-Dindo classification.   "
2367|NCT03254901|"     Viral hepatitis is a global health problem affecting hundred millions of people worldwide and     considered the main cause of liver cirrhosis, hepatocellular carcinoma and liver     transplantation in developing countries.   "
2368|NCT03254888|"     • Bladder cancer is the most common malignancy of the urinary tract. It represents the 7th     most commonly diagnosed cancer in male population worldwide and drops to the 11th when both     genders are considered . According to the American cancer society's estimates of bladder     cancer in 2017, the number of the new cases of bladder cancer is 79,030, and the mortality     figures reached 16,870 .   "
2350|NCT03255122|"     The goal of the study is to evaluate the efficacy of an Internet-delivered format of an     evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior     and Leading by Modeling, or the CALM Program) in which therapists and families meet in     real-time via videoconferencing and parent-child interactions are broadcast from the family's     home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a     randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social     anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and     20 will be assigned to a waitlist control and will complete a course of I-CALM after the     waitlist period. Outcomes will be assessed via structured diagnostic interviews and     parent-report questionnaires.   "
2351|NCT03255109|"     WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE) is a     multi-centre, prospective, observational, 4-week inception cohort study being carried out by     the Acute Respiratory Failure section of ESICM. Weaning represents a challenge for     intensivists and patients spend a considerable amount of time in being liberated from     mechanical ventilation. While guidelines do exist on the classification of weaning, a recent     study has shown that these may not be applicable to all patients. Moreover, different     practices exist in regard to weaning procedures. WEAN SAFE will prospectively assess the     burden of, management and spectrum of approaches to weaning from ventilation, in patients     that require invasive mechanical ventilation for any reason, for a time period of at least 24     hours.   "
2352|NCT03255096|"     The purpose of this study is to evaluate the safety, tolerability and clinical activity of     RO6870810 in combination with venetoclax and when co-administered with rituximab in     participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).   "
2353|NCT03255083|"     This study has two parts: dose escalation and dose expansion.      The primary objectives are:        -  For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined          with osimertinib in the study population and to determine the recommended dose for          expansion of DS-1205c when combined with osimertinib in the study population        -  For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with          osimertinib in the study population      In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle     1 onward). In Dose Expansion, there will be 21-day cycles.      The number of treatment cycles is not fixed in this study. Participants will continue study     treatment for 36 months unless they decide not to (withdraw consent), their disease gets     worse [progressive disease (PD)], or side effects become unacceptable (unacceptable     toxicity).   "
2359|NCT03255005|"     The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty     (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular     by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a     delayed treatment control group (diet alone; crossover at 6 months) with a treatment group     (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.   "
2360|NCT03254992|"     Individuals with Autism Spectrum Disorder (ASD) are known to have difficulty with     socio-communicative functioning and restricted or repetitive behaviors or interests, and     there is considerable evidence that the majority also struggle with associated emotional     problems. Speech is typically delayed or may regress, comprehension is impaired, if not at     the word level, then at the level of sentences, nonverbal and verbal language are affected,     and pretend play is delayed or absent, some children are nonverbal or have sparse,     impoverished, poorly articulated, and grammatical speech. Objective: To assess in which     interface has ASD best performance or functionality. Method: Will be evaluated 100     individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum     Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with     typical development (TD-group) matched by age and sex to the ASD-group. Individuals with     comorbidities and functional disabilities that would impede the completion of the task were     excluded.   "
2361|NCT03254979|"     RATIONALE The translation into clinical practice of Primary Care (PHC) of effective and     sustainable interventions to prevent of type-2 diabetes (T2D) remains an unresolved     challenge. Leadership, active involvement of professionals, facilitation and adaptation to     the local context and their determinants are known to be key components in the success of     implementation strategies that seek to optimize clinical practice. However, one of the areas     in which there is still no evidence is related to the effectiveness of different strategies     to engage healthcare professionals in such innovation processes. Especially in real-world     Primary Care clinical contexts characterized by work overload and limited time, with marked     differentiation of professional status, both at the level of identity and competency.      OBJECTIVES To assess the effect of PHC providers engagement procedure in the creation and     execution of a facilitated collaborative modelling process, in the adoption, reach,     implementation and effectiveness of the recommended clinical practice for the prevention of     type-2 Diabetes      METHODOLOGY      Randomized cluster hybrid trial in which 9 PHC centres from Osakidetza will be allocated to     two different strategies to engage professionals and create an inter-professional     collaborative practice directed by a local leader and an external facilitator, to optimize     the integration of a T2D primary prevention program:        -  A strategy focused on the sequential activation: started in nursing, which finally          manages to involve the whole center        -  A global strategy with the participation of all professionals from the beginning      All centres and PHC professionals will receive training on current guidelines and scientific     evidence in primary prevention of T2D and effective interventions to promote healthy     lifestyles. Headed by a local leader and an external facilitator, centres will conduct a     collaborative structured process to model and adapt the intervention and its implementation     to the specific context of professionals and centres, and the determinants of T2D prevention     practice. One of the groups will perform this strategy globally, promoting the cooperation of     all health professionals from the beginning. The other will perform it sequentially, centred     first in nursing, who will lately seek the pragmatic cooperation of physicians and other     professionals.      All patients without diabetes aged ≥30 years old who attend at least once in collaborating     centres at high risk of developing T2DM (FINDRISC> = 14 points and / or intermediate     hyperglycaemia) will be eligible for program inclusion. The main outcome measures focus on     observed changes in T2DM prevention clinical practice at centre level after 12 and 24 months,     as a result of the implementation of one or another engagement strategy. Secondary outcomes     will compare their clinical effectiveness in changing exposed eligible patients' main     cardio-metabolic risk factors (Weight, BMI, Cholesterol, Glucose, Triglycerides) and     lifestyles behaviours (physical activity and diet) after 12 months.   "
2362|NCT03254966|"     To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to     severe active rheumatoid arthritis.   "
2364|NCT03254940|"     This study evaluates different versions of a text messaging-based app for weight loss. This     study will place participants to 1 of 32 experimental conditions that reflect different     texting components and levels. Participants will be randomized to a condition. The     investigators will recruit 448 adults into a 6-month weight loss program, with an additional     follow-up 6-months after the intervention ends.   "
2366|NCT03254914|"     The purpose of this study is to evaluate the effect of home blood pressure monitoring on     controlling blood pressure and correlation between home blood pressure and clinic blood     pressure in hypertensive patients receiving two or more concomitant antihypertensive agents     including fimasartan   "
2372|NCT03254836|"     Objective The objective of the current trial is to investigate the effect of perioperative     sleep and circadian rhythm on the natural course of survival among patient diagnosed with     colorectal cancer. Concurrently, outcome measures like depression, fatigue, quality of life,     and co-morbidity will be measured continuously in the short-, intermediate- and long-term     period following diagnosis.      The a-priori hypothesis is that preoperative sleep and circadian disturbances is a prognostic     marker of reduced overall survival. Likewise, preoperative sleep-wake disturbances at     baseline are expected to result in overall universally reduced quality of life, increased     depression and fatigue. Furthermore, development of sleep-wake disturbances in the     postoperative period as compared to preoperative sleep-wake rhythm is expected to a     prognostic marker of negative outcomes.      Target and study population The study population are all patients diagnosed with colorectal     cancer in Region Zealand recruited consecutively from the trial initiation until study end     each patient with an intended 5 year follow-up period. All available cases will be included     in the trial.      Study design The study will be an observational prospective cohort study applying a     longituditional repeated measure design.      Exposures and outcomes of interest The primary outcomes in the trial are sleep and circadian     outcomes measured via actigraphy in the perioperative period.      Furthermore, cancer related survival and overall survival in the 5 year follow-up period is     considered primary outcomes.      Secondary outcomes consist of consecutively measured depression, fatigue, quality of life,     follow-up treatment and co-morbidity.      Exposure variables are primary related to the cancer, i.e. cancer stage, surgical treatment,     oncological treatment, baseline co-morbidity and pharmacological treatment. Some of the     secondary outcomes could be expected to serve as confounding or mediating factors.      Meaningful control for confounding will in the analysis phase be cancer stage and baseline     sleep-wake rhythm status.      Sampling methods All available cases will be sought included in the trial. No formal sample     size has been performed and continues inclusion into the trial will be performed during an     1,5 year period.      Statistical analyses The relationship between overall survival and baseline sleep-wake rhythm     will be investigated using survival statistics and/or multivariate logistic regression.      Expected results The investigators expect to see a marked difference in overall survival     among patients with sleep and circadian disturbances at baseline.   "
2373|NCT03254823|"     This study investigates whether there is an immune response directed against gut microbes or     food and parts of the body in severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome     (ME/CFS) patients.   "
2374|NCT03254810|"     This is a single site, parallel randomized, double blinded comparison of the safety,     pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57     mg/kg dose of adalimumab (Humira®) reference product from North American and European     sources. The study is open to healthy individuals on no medications that might confound the     results of this safety study.   "
2375|NCT03254797|"     Does a 4-week stepping training program with or without external feedback clinically change     functional ability and reduce risk of fall of ambulatory patients with iSCI?      Are there significant differences between 4-weeks stepping training with or without external     feedback in ambulatory patients with iSCI?   "
2376|NCT03254784|"     The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165     capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie     meal and increased gastric pH on the BMS-986165 tablet formulation.   "
2377|NCT03254771|"     The main goal of this study is assess the effectiveness of a DA for patients with knee     osteoarthritis candidates to ART   "
2378|NCT03254758|"     This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells     (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with     liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase     2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated     against the same target population in Phase 2.   "
2379|NCT03254745|"     Osteoarthritis (OA) is an auto-immune chronic progressive deteriorating disease of the joints     resulting in joint inflammation, pain and swelling that renders patients with reduced     mobility and quality of life. Prevalence of knee osteoarthritis in Pakistan is 4.6%. It is     believed that pharmacists can play a role in managing treatment outcomes of osteoarthritis     patients by providing pharmaceutical care.   "
2380|NCT03254732|"     This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with     pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks. Assessment of safety and     tolerability of drug combination   "
2395|NCT03254537|"     Results from a small number of human cohort studies are also available and indicate that     there are positive associations between organic food consumption and reduced risk/incidence     of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight.      Results from animal dietary intervention studies suggest that (i) switching to organic food     consumption results in significant changes in hormonal balances and an increase in immune     system responsiveness and (ii) differences in pesticide residue, cadmium, protein and     antioxidant concentrations between organic and conventional foods are major drivers for     hormonal balances and immune system parameters in animals.      However, there is virtually no published data from (i) long-term cohort studies focusing on     chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative     conditions) and (ii) controlled human dietary intervention studies comparing effects of     organic and conventional diets. It is therefore currently not possible to assess whether and     estimate to what extent organic food consumption may affect human health.   "
3712|NCT03237325|"     To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe     oral mucositis in patients receiving chemoradiation treatment for the treatment of head and     neck cancer   "
2381|NCT03254719|"     The primary objectives of this pilot trial are to evaluate the feasibility, safety and     acceptability of an integrative care pathway that includes chiropractic care, for the     coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP),     with an emphasis on those with mental health comorbidity, in preparation for the conduct of     an appropriately powered multi-site randomized controlled trial (RCT). The secondary     objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and     10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use     in a future RCT; and 3) determine preliminary intervention effect sizes and variability to     aid in sample size determination for a future RCT. The investigators hypothesize that     chiropractic care offers relief for pain and mental health symptoms through the direct     effects of treatment-focused CMT, as well as through the indirect, non-specific effects of     the team-based relationship with the clinician.      This pilot study is a single-arm trial. All participants will be asked to complete study     outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and     interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as     the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale     (GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder     Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool     (STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary     and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life,     General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool     and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability,     mental health, quality of life enjoyment and satisfaction. All participants will receive up     to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and     10 of the study.   "
2471|NCT03253549|"     The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at     home, on patients undergoing cardiac and major vascular surgery, to determine the effect on     the 45-day risk of hospital readmission and emergency department visits. Half of participants     will receive the SMArTVIEW intervention of increased monitoring, while the other half will     receive standard care after surgery.   "
2382|NCT03254706|"     Objective: This double-blind randomized clinical trial evaluates the influence of increased     application time of a new etch-and-rinse two-step adhesive Single Link; (Angelus Dental     Products Industry) applied in non-carious cervical lesions (NCCLs).      Methods: A total of 221 restorations were randomly placed in 35 patients assigned in four     groups to two different etch-and-rinse two-step adhesive Peak® Universal Bond (P) (Ultradent     Products Ind) and Single Link (SL) (Angelus Dental Products Industry). The adhesives systems     were applied on the NCCLs follows: P1 - applied according to the manufacturer's; P2X -     applied for the double time; SL1 and; SL2X. The resin composite Amelogen (Ultradent) was     placed incrementally. The restorations were evaluated imediataly (baseline), 6 and 12 months,     using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests     (=0.05).   "
2383|NCT03254693|"     Objective: This double-blind randomized clinical trial evaluates strategies for improving the     bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new     universal multi-mode adhesive (Ambar Universal; FGM).      Methods: A total of 134 restorations were randomly placed in 19 patients according to the     following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+     - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The     restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and     USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).   "
2384|NCT03254680|"     This is a single center open-label pilot clinical trial of patients 1-70 years of age with     greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome,     Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a     stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers     will be asked to keep a seizure diary logging all clinical events during the course of the     study. Serum comprehensive metabolic panel, complete blood count with differential, and     antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3     months.   "
2385|NCT03254667|"     Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with     Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis   "
2386|NCT03254654|"     Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer   "
2387|NCT03254641|"     We have in a pilot study found that serum calcium levels change in response to hCG     stimulation test. We observed that serum calcium level measured at baseline and 72 hours     after hCG stimulation were different in men with gonadal insufficiency referred for this     stimulation test. Now we want to investigate a large cohort of men referred for hCG     stimulation test due to suspected impaired gonadal function.   "
2388|NCT03254628|"     The study aims are to evaluate the impact of supportive follow-up strategies for a novel     twinned training and capacity-sustaining program among frontline health workers (providers)     attending facility-based births in remote and district level health facilities in Uganda. The     program is designed to improve provider competencies, provider performance and health     outcomes among women giving birth and newborns.   "
2389|NCT03254615|"     The current project seeks to evaluate the effectiveness of numerous educational strategy     interventions to increase the percentage of water consumed among early elementary school     students over a 1-year period.   "
2390|NCT03254602|"     A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of     Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue     pain reduction began in August 2016 and was completed in April 2017. The clinical setting:     University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal     study for chronic plantar fasciitis.   "
2391|NCT03254589|"     The investigators will study the effects of methotrexate on blood pressure, arterial     stiffness and endothelial function in patients with rheumatoid arthritis.   "
2392|NCT03254576|"     The objective of the study is to compare children at low risk for obesity (two healthy weight     parents) to children at high risk for obesity (two overweight parents) in their response rate     to food taste and in their rate of learning using fMRI.   "
2393|NCT03254563|"     Copeptin, a surrogate marker for vasopressin, has been found to be elevated in metabolic     disorders including obesity and diabetes, which are disorders both associated with     nonalcoholic fatty liver disease (NAFLD), and therefore suggest a potential role for     vasopressin in the pathogenesis of NAFLD. US population currently drinks on average 1-1.5L of     water a day, which is less than recommended water intake (2.5L of water). Therefore, we wish     to look at whether recommended water intake compared to average water intake improves     copeptin (and thus vasopressin levels) along with improving markers of NAFLD.   "
2394|NCT03254550|"     An 18 month observation cohort study with the overall aim to assess the operationalization of     oral Pre-exposure prophylaxis (PrEP) in Swaziland as an additional HIV combination prevention     method among population groups and individuals at high risk of HIV infection.   "
12973|NCT03115619|"     This multicenter, post-marketing, observational study will evaluate quality of life in     participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone     (Esbriet).   "
2396|NCT03254524|"     The goal of this study is to create predictive models of emergency care and metrics for     population health that can be used to analyze how events like hospital closures or disasters     like Hurricane Sandy affect health care utilization by patients in specific populations or     geographic regions. Additionally, it will allow the development of metrics for population     health that can act as surveillance mechanisms to measure disease prevalence and identify     patterns in emergency department use that can be used to identify specific geographic regions     where health care is either optimized to promote health or needs to be improve so that     population health can be improved.   "
2461|NCT03253679|"     This phase II trial studies how well WEE1 inhibitor AZD1775 works in treating patients with     solid tumors with CCNE1 amplification that have spread to other places in the body and do not     respond to treatment. WEE1 inhibitor AZD1775 may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
2462|NCT03253666|"     To determine the relationships of dietary factors with the subsequent risk of dermatological     diseases (such as skin cancers and inflammatory or autoimmune dermatoses) in a cohort of     female registered nurses and male health professionals.   "
2397|NCT03254511|"     This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion     criteria are consist of non-metastatic esophageal cancer who are going to receive     chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention     group, patients are going to inject an enoxaparin (40 mg) daily concurrent by     chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to     control group (only chemo-radiotherapy) and intervention group     (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all     patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological     findings (after esophagectomy) are considered as clinical and pathological response,     respectively.   "
2398|NCT03254498|"     A randomised back to back study comparing cap and Endocuff to detect adenomas during     colonoscopy   "
2399|NCT03254485|"     The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of 3 dose     levels of IW-1973 compared with placebo when administered daily for approximately 12 weeks to     patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise     capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.   "
2400|NCT03254472|"     The investigators conducted a retrospective analysis of all measured concentrations performed     in a large subset of laboratories located in the French Brittany from February 2010 the 17th     to August 2015 the 30th, in adults over 20 years old.      The investigators are aimed at studying physicians' use and eventually misuse of biomarkers     dosage and the characteristics of a broad population based on some biomarkers concentrations.   "
2401|NCT03254459|"     This study will evaluate the safety and tolerability based on the incidence of adverse     experiences of buprenorphine sublingual spray (0.5 mg three times daily [TID]) compared with     standard post-operative narcotic therapy in participants with postoperative pain. Standard     post-operative narcotic therapy is defined as morphine intravenous injection (IV) (4 mg TID)     followed by oxycodone hydrochloride tablet (10 mg TID).   "
2402|NCT03254446|"     The phase III trial is designed with an aim of determining the efficacy of Investigational     Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e.,     HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel     group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study     subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to     their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26     weeks.   "
2403|NCT03254433|"     This research study is a sub-study within the Behavioral Activation for Smoking Cessation and     the Prevention of Post-Cessation Weight Gain main study (NCT02906787). Participants who are     eligible for the main study and meet certain MRI (Magnetic Resonance Imaging) related study     criteria (i.e. conditions) may also elect to complete a series of computer tasks inside a     standard, closed MRI scanner to examine changes in brain activity associated with the smoking     cessation counseling that participants will receive in the main study. In total, participants     will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling     session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment     period.   "
2404|NCT03254420|"     The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology     using electromagnetic transponders implanted within the prostate. It is a real-time target     tracking system that takes into account both inter- and intrafractional target motion. So the     exact position and movement of the prostate can be determined during radiation therapy     treatment.      The aim of this study is to assess pelvic late toxicity rate after intensity-modulated     radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In     this randomized study, patients will receive IGRT treatment using the Calypso system or a     conventional IGRT treatment.   "
2405|NCT03254407|"     The goal of this study compare the effectiveness of an electronic note versus a telephone     call to alert the prescriber of a possible IV to oral switch. Secondary endpoints are the     time-to-switch and the economic impact of earlier IV to oral switch.   "
2406|NCT03254394|"     Oxaliplatin-induced neuropathy is a major dose-limiting side effect in patients with     colorectal cancer treated with the FOLFOX chemotherapy regimen. Hypersensitivity to cold is     the sensory hallmark of oxaliplatin-induced neuropathy, and it can predict the development of     long-term neuropathy. In this study, the investigators aim to determine whether intravenous     lidocaine can prevent oxaliplatin-induced cold hypersensitivity.   "
2407|NCT03254381|"     Older adults with type 2 diabetes experience cognitive decline and are at higher risk for     developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (based     on body mass, glucose levels) are at higher risk for cognitive decline, and intervening at     this point may prevent or delay the onset of such decline. One promising lifestyle     intervention that has been shown to improve cognitive function in other populations is     exercise. However, before investigators can examine whether exercise will improve cognitive     function and brain health (structure and function) in this at-risk population, a feasibility     pilot study is needed to determine whether a larger-scale trial would be viable.   "
2408|NCT03254368|"     The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061     in participants with type 2 diabetes.   "
2472|NCT03253536|"     Prospective single arm, single center observational study to evaluate Quality of Life (Qol)     after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will     receive work-up, treatment and follow-up exclusively as routinely done except additional     quality of life measurements. Qol will be measured by standardized and validated EORTC     questionaires at different time points during routine follow-up.   "
2506|NCT03253094|"     This is a multicenter, randomized, double-blind, double-dummy, active-controlled,     dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus     oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute     Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per     treatment group) will be enrolled and randomized into the study.   "
2563|NCT03252353|"     Octreotide capsule is a novel, orally-administered formulation of the commercially-available     injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated     maintenance of biochemical response up to 13 months in the majority of patients with     acromegaly previously managed with somatostatin analog injections (reference below).   "
2409|NCT03254355|"     Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of     women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the     muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led     to the discovery of this previously unknown major injury and further research now enables its     diagnosis with readily available techniques. Avulsion injury has alarming consequences     because it has been associated with a higher rate of urinary incontinence in the postpartum     period as well as the long-term development of other major urogynecological conditions such     as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from     severe symptoms with significant related impacts on physical activities, overall well-being     and quality of life, but they also present a higher rate of surgical failures. Moreover, it     is still unknown whether the most recommended first-line treatment for urinary incontinence     -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot     study conducted by our team supports the rationale and the efficacy of physiotherapy for     improving PFM function in women with avulsion, despite their major muscle injury.      Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in     women with avulsion at 9-months after randomization compared to a waiting-list control group.      Secondary objectives:        1. To compare physiotherapy to the control group after treatment and at 9-months after          randomization in terms of: a) incontinence and prolapse (objective quantification,          symptoms and related impact); b) PFM morphology and function; c) sexual function; d)          self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change.        2. To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral)          on the response to physiotherapy treatment on the aforementioned outcomes.   "
2410|NCT03254342|"     We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration     levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed     patients.   "
2411|NCT03254329|"     The primary purpose of the proposed research is to establish Reference Values (RVs) for     micronutrients (MN) and macronutrients in human milk. The investigators' research to date has     revealed highly variable milk MN concentrations among populations, and very low values in     some low income countries (LICs) likely caused by poor maternal status and/or diet. During     the past year the investigators conducted a review of human milk nutrient composition, and     formed a Technical Advisory Group (TAG) which developed the current proposal. Here, the     investigators propose to conduct a longitudinal project on well-nourished women and     infants.Therefore Mothers, Infants and Lactation Quality (MILQ) study is a multi-center     cohort study, investigating breast milk nutrient composition in well-nourished women across     the first 8.5 months of lactation in four different populations. The countries involved are     Denmark, Brazil, Bangladesh and The Gambia. Other data collected on mothers and infants,     including nutrient intake and status, morbidity and milk volume, and infant development, will     inform interpretation and support application of the results. While the original priority is     to develop RVs only for MN, the investigators include human milk oligosaccharides (HMOs) and     proteins, and free amino acids (FAA) in infant serum because of a recently published     association between low serum FAA and stunting in young children. Thus, with the samples     obtained the investigators will perform (a) laboratory analyses of milk, plasma and urine     macronutrients and MN to construct RVs for global application, (b) analyses of HMOs and     proteins in milk, and (c) metabolomic analysis of FAA and other metabolites in infant plasma.     By request of the Bill and Melinda Gates Foundation (BMGF) colostrum and fecal samples will     be collected and stored for later analyses.   "
2412|NCT03254316|"     Healthcare - Associated Infection Surveillance In Neonatal Intensive Care Unit of Assiut     University Children's Hospital.The objective of study is to determine the incidence,     infection sites, causative organisms and risk factors related to healthcare-associated     infections in NICU in Assiut University Children hospital.   "
2413|NCT03254303|"     This interventional simple-blind,randomized trial has included 90 children of American     Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of     either sex, scheduled for for outpatient minor surgery under general anesthesia. This study     examined whether one should make iv attempts during the early induction period (at 60     seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane     inhalation anesthesia.   "
2414|NCT03254290|"     This randomized control study will use 15 pediatric subjects selected from the patient     population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC     Dental Clinic). The study will use a within-subject control design whereby one tooth will be     treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc.,     Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with a     formocresol pulpotomy and restored with a multi-surface composite; thus, approximately 15     teeth will be treated for each treatment group. The specific treated tooth will be randomized     as to which side will receive the MTA or formocresol using sealed, opaque envelopes.     Approximately 15 subjects will be needed for the study in order to elicit any significant     findings as demonstrated by a power analysis.   "
2415|NCT03254277|"     This study is a phase 1, open label, dose-escalation study of the mAb 3BNC117-LS administered     intravenously in HIV (human immunodeficiency virus)-uninfected individuals and HIV-infected     individuals. The objectives of the study are to evaluate the safety, tolerability and     pharmacokinetics of a single infusion of 3BNC117-LS in HIV-uninfected and HIV-infected     individuals.   "
2416|NCT03254264|"     The Early start Denver model (Rogers, 2010; Dawson, 2010) is a developmental and behavioral     model that aim to enhance socio-comunicative abilities and also global development of     children with Autism spectrum disorder (ASD). The purpose of this study is to identify     changes in neurocognitive profile of children population with ASD receiving Early Start     Denver Model (ESDM) applied 12 hours per week in comparison to children receiving other     interventions. That is a study proposed to children with ASD and their families that     participate already to a randomized control study called IDEA registered on     clinicaltrials.gov NCT02608333.      the investigators hypothesized that ESDM would increase social cognition, reduce shifting     attention time and increase preference for unpredictable stimuli.   "
2417|NCT03254251|"     We used a parallel experimental design. Following an initial screening and familiarization     session of study tests and procedures, eligible postmenopausal women were randomly assigned     to a stair climbing (SC) group or non-exercising control group. SC training session was     progressive program, and was performed 4 days a week for 12 weeks. Measurements were     collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning     following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48     and 72 hours after the last exercise session.   "
2579|NCT03252145|"     This study will be a 4-week randomized, controlled, assessor blinded, trial comparing a     negative pressure massage device (intervention group), to the standard manual lymph drainage     massage (control group), in breast cancer patients with chronic upper extremity lymphedema.   "
2418|NCT03254238|"     Prescription drug abuse is a major challenge in public health, in particular in countries     such as France, one of the main consumers of medication in Europe. A single source of     information is rarely sufficient to measure such a complex phenomenon. This project entitled     MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete     efficiently the available data from the addictovigilance centres allowing the health     authorities (French Drug Agency) to answer to the main general questions (What are the main     prescription drug abused in France? What are the national trends in prescription drug abuse?     What is the impact of a public health measure on prescription drug abuse). This project     constitutes the opportunity of extending the application of our tool (the DS method) on a     French national database with a minimal risk since this method has already been validated and     applied on different geographic areas, on different drugs and at different levels of     analysis. The project would also be integrated in routinely as a useful tool included in the     addictovigilance monitoring, also allowing a multi-approach approach and the monitoring of     policy and practice interventions implemented by the French Drug Agency.      The project MEGADOSE is also in accordance with the main topic of the projects funded by ANSM     related to drug misuse in particular: development and identification of systems and tools     able to detect earlier misuse phenomenon; analysis of the impact of communications,     guidelines, decisions to health authorities and patients   "
2419|NCT03254225|"     This study evaluates the inffluence of 16 weeks of resistance training on heart rate     variability of hypertensive elderlies patients. All volunteers will be divided in two groups,     one will participate in a protocol of sixteen weeks of resistance training, an the other will     remain sedentary.   "
2420|NCT03254212|"     The aims of this study are to 1) determine the optimal levels of O2 flow which prevent     nocturnal O2 desaturation while minimizing periods of hyperoxia during the course of     nocturnal oxygen therapy (NOXT) in heart failure patients with reduced ejection fraction     (HFrEF) patients with CSA/CSR; 2) document whether within-patient EO2F values change over     time during NOXT, and identify factors which predict changes in EO2F; and 3) examine how well     a conventional stepwise titration procedure compares to a breath by breath titration using an     automated O2 titration system in terms of targeted flow rate and night time oxygenation     (oxygen desaturation index, time spent at specific SpO2 targets).   "
2421|NCT03254199|"     The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with     Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps. Participants will be asked to     take two study products during the course of the study. One of these study products will be a     placebo.      Approximately 120 participants in 20 study centers across the United States are expected to     take part. Participants will be in the study for approximately 3 months and visit the study     clinic 3 times.   "
2422|NCT03254186|"     Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic     movement disorder that can occur in anyone exposed to drugs that block dopamine receptors,     including first and second generation antipsychotics and antiemetic agents. There is no way     to prevent TD except preventing exposure to the inciting agents and there are no approved     symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting     its use as a treatment for TD.      The goal of this study is to determine the efficacy of propranolol in the treatment of TD in     a double-blind, cross-over prospective manner. If propranolol is found to be an effective     therapy, it will fulfill a great need in the treatment of TD with a medication that is known     to be safe and inexpensive.   "
2423|NCT03254173|"     A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA     approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome.      Two arms will be compared . Arm A will involve 50 patients with confirmed advanced cancer     receiving mirtazapine 15 mg once daily for 8 weeks & Arm B will involve another 50 patients     with confirmed advanced cancer receiving placebo for 8 weeks.      Both arms will be compared to assess efficacy of mirtazapine in appetite stimulation     primarily and to assess other outcomes secondarily which will be discussed later in details.   "
2425|NCT03254147|"     This is a retrospective, observational, claims cohort study to assess, for adult patients     initiating an oral anticoagulant for NVAF   "
2426|NCT03254134|"     This is a comparative effectiveness and safety study of clinical events among patients taking     either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to     provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and     bleeding events (safety) using 95% confidence interval for comparison between those     non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large,     nation-wide claims data in Japan.   "
2427|NCT03254121|"     In this international collaboration study, we will analyze somatic mutations of     hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in     patients treated with hepatitis C (HCV) therapy   "
2428|NCT03254108|"     The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent     to that for oral administration of tolvaptan 15-mg tablet will be investigated by     administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with     congestive heart failure.   "
2469|NCT03253575|"     The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and     different assay developed to test the sensitivity of different cancer types to physician     selected therapies (both drugs and/or drug combinations) indicated for the stage and type of     cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies     being considered by the treating physician. CANscript™ test results have been shown to     closely correspond with actual clinical results, providing physicians with information that     may help him/her develop a more personalized cancer treatment and care plan based on the     patients specific condition. The researchers want to see if CANscript™ test results are     helpful in selecting the treatments prescribed and provided. There will be about 800 people     taking part in this study, across 5 different tumor types. The study is designed to assess     the decision impact of the CANscript™ test results in informing physicians in therapy     selection.   "
2564|NCT03252340|"     This study aims to evaluate safety in subjects with over moderately subacute and chronic     atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an     observational study of patients participated in Phase 1 clinical trials, no drug is     administered in this study.   "
2429|NCT03254095|"     Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to     individuals and the society and it is expected to be the 7th leading cause of death in 2030.     Diabetes related complications manifest in many body parts, often in the foot, due to reduced     blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar     pressures during walking contribute to the development of foot ulcers and foot ulcer     recurrence. Emerging studies also point skin temperature as another predictor of foot     ulceration. However, the number of studies including prediction models of plantar pressure     and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic     foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue,     foot deformities and other diabetes related characteristics have been related to plantar     pressure measurements but not to foot skin temperature measurements, and the relation between     skin temperature and plantar pressure has not been much explored in the literature. The role     of these variables in the development of foot ulceration needs further attention, especially     in patients with history of foot ulcers has they are at the highest risk to develop a foot     ulcer.      Therefore, the goal of this research is to determine which variables can be used to predict     plantar pressure and skin temperature and which factors are associated with the development     of foot ulcers in patients with established diagnosis of diabetic foot. The associations     between skin temperature and plantar pressure will also be addressed.   "
2430|NCT03254082|"     Given the interest in gluten-free foods and discovering dietary means to prevent metabolic     disorders, this study was designed to determine the glycemic responses of four (4) grains and     flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects     and blood glucose will be collected prior to and after eating over the course of two hours. A     dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as     the control treatment.   "
2431|NCT03254069|"     The aim of this study was to determine if restoring primary molars with SSCs would improve     children's OBF.   "
2432|NCT03254056|"     This study compares post-operative incisional pain on post-operative days 1 and 7 who will     undergo gynecologic laparoscopic operations. Half of participants will undergo conventional     fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl     Storz, Belgium).   "
2433|NCT03254043|"     This study will evaluate whether a commercially available, secure, electronic pill box is a     feasible, acceptable, and satisfactory method to manage take-home dosing of methadone for     both methadone clinic patients and staff members.   "
2434|NCT03254030|"     This is a prospective randomised controlled trial to assess an intervention of inspection     during both phases of colonoscopic examination ( insertion and withdrawal) improve adenoma     detection rate when compared to inspection only during withdrawal.   "
2435|NCT03254017|"     The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic     conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing     number of studies indicates that that overactivity in the lateral habeluna(LHb) is present     during depressed states, where it could drive the changes in midbrain activity linked to     depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris     thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical     case of directly stimulating habeluna for treatment TRD. This research will investigate     effectiveness bilateral DBS to habenula for patients with TRD.      Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy.     Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal     control of clinical symptoms. Remote programming of DBS can markedly improve patient     convenience, minimize risk of infection and total treatment time and lead to an overall     benefit for doctors and patients alike. This research will also investigate safety and     benefit of remote programming of DBS.   "
2436|NCT03254004|"     A single center, open-label, single arm study in patients who have solid or micropapillary     adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Pembrolizumab 200     mg every 3 weeks   "
2437|NCT03253991|"     A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy     Treatment of Medication Refractory Essential Tremor Subjects      The objective of this prospective, single-arm study is to test the efficacy of treatment     using the ExAblate Transcranial System and to further demonstrate safety in     medication-refractory tremor inpatients with essential tremor (ET).      The Indications for Use claim for this system is as follows: Treatment of     medication-refractory tremor in patients with essential tremor.   "
2438|NCT03253978|"     The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to     deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the     effect of SABR on levels of markers of radiation exposure and bowel damage, along with other     potential markers of outcome and side effects. Quality of life and any side effects that     develop during and after treatment will also be assessed.   "
2439|NCT03253965|"     The purpose of this study is to determine how using auditory cues of a metronome and music at     various frequencies impacts the gait mechanics in people with Parkinson's disease when     walking over ground and on a treadmill.      The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of     Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired     subjects.      Participants will complete 7 different treadmill walking conditions and overground walking     conditions while the investigators measure step length, cadence, gait speed, and variability     of movement.   "
2440|NCT03253952|"     The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal     instability) that develop after SCI have value in predicting SCI-associated infections     (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery     potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in     both the time and frequency domains to discriminate between the relative contribution of     sympathetic and parasympathetic innervation to changes in HRV. The ability to predict     infections will enable novel treatments thereby reducing infection-associated mortality and     improving neurological and functional outcomes.   "
2470|NCT03253562|"     This is a controlled study to measure the efficacy of using metformin or vildagliptin for     type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk     resulting from both diabetes and hypertension using different parameters measuring   "
2441|NCT03253939|"     Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median     survival of less than one year. Systemic chemotherapy including targeted agents has not been     found to significantly increase the survival in Gastric cancer associated peritoneal     carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in     many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic     intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal     carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications     in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic     intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal     recurrences in many randomised trials in Asian countries; as a definitive treatment in     established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is     the only therapeutic modality that has resulted in long-term survival in select groups of     patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal     chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal     chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still     evolving and needs larger studies before it is accepted as a standard of care.   "
2442|NCT03253926|"     In this study, the investigators are interested in testing how lorcaserin influences the     effects of cannabis in a human laboratory model of cannabis use.   "
2443|NCT03253913|"     RESULT is a phase II dose-escalating, open-label, safety and efficacy study to determine if     there is a potential benefit of resveratrol in combination with sirolimus in patients with     lymphangioleiomyomatosis (LAM). The primary study objective is to assess the change in serum     vascular endothelial growth factor-D (VEGF-D) level after 24 weeks of treatment with a     combination of resveratrol and sirolimus as compared to the VEGF-D level in patients on a     stable dose of sirolimus alone. The secondary objectives of this study include an assessment     of the safety and adverse effect profile of combined resveratrol and sirolimus in adult     patients with LAM, and to determine the effect of treatment with a combination of resveratrol     and sirolimus on changes in lung function and quality of life.   "
2444|NCT03253900|"     Rowing simulators are frequently used by rowers, when on-water training is impossible or     limited. While such devices are highly valuable to maintain rowers` fitness, a concern was     raised about extensive simulator usage. It was postulated that it could lead to technique     alterations due to different biomechanical properties compared to on-water rowing.     Slide-based rowing simulators were designed to better simulate on-water conditions.      The main aim of the study was to compare the differences in various kinematic and kinetic     parameters during a short (20 s) all-out rowing bout and during a 2000-m simulated race, to     get a better insight into how different rowing simulator designs affect biomechanics of     rowing.      Three different rowing simulators were used in this study: (1) a standard stable/fixed rowing     simulator, (2) a slides based rowing simulator, i.e. horizontal plane unstable, and (3) a     tilt board based rowing simulator; i.e. frontal plane unstable.      The investigators hypothesised that rowing on different simulators will elicit different     biomechanics, including forces, power output, arm and seat movement velocity and amplitude.      Each of the participants completed the tests in all three interventions on separate sessions;     random order of interventions. The three sessions took place 7-10 days apart. During each     session, the participants completed the all-out 20-s trial first, then the simulated 2000-m     race. The aforementioned biomechanical parameters were tracked throughout the trials to be     compared between interventions later.   "
2445|NCT03253887|"     Central venous catheter infection is a common complication in pediatric patients, resulting     in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and     increase morbidity and mortality. Given the repercussion of this complication, measures that     minimize its should be stimulated. The purpose of this study is to evaluate the effects of     intraluminal alcoholization (ethanol lock therapy) on prevention of infection of short-term     central venous catheters in pediatric patients.   "
2446|NCT03253874|"     A multi-disciplinary intervention will reduce inappropriate preoperative testing for cataract     surgery. Despite multiple rigorous randomized controlled trials and meta-analyses showing     that pre-operative testing for cataract surgery does not improve outcomes, pre-operative     testing has not declined. A quality improvement initiative, which includes gaining senior     leadership support, changing the culture of care, and elimination of pre-operative     consultation visits for cataract surgery, to reduce inappropriate pre-operative testing.     Quasi-experimental difference-in-difference analysis comparing the intervention arm (LAC+USC     Medical Center) with the control arm (Harbor-UCLA Medical Center), 6 months prior and 6     months after the intervention. Generalized estimating equation models will adjust for age,     gender, race/ethnicity, comorbidities and cluster by site.   "
2447|NCT03253861|"     Severe acute pancreatitis is a common reason for intensive care unit (ICU) admission and is     associated with prolonged hospital stays and high morbidity and mortality rates. The Atlanta     classification differentiates mild, moderate, and severe acute pancreatitis, and each of     these categories correlates with morbidity and mortality. Mortality remains high, between 10%     and 39%, in severe and moderately severe acute pancreatitis. After the first week, about 30%     of patients with necrotizing pancreatitis develop infected pancreatic necrosis (IPN). IPN is     a risk factor for mortality.The treatment of IPN combines antibiotics with interventions to     remove the infected intra-abdominal material, preferably using minimally invasive techniques     such as percutaneous and endoscopic drainage, which have been proven beneficial. In several     studies biological markers such as procalcitonin and interleukin 8 were effective in     predicting IPN. However, few clinical risk factors for IPN have been reported. Identifying     risk factors may help to improve standardized strategies for early diagnosis and treatment,     and then patients outcome. Our primary objective was to identify risk factors for IPN in     patients admitted to the ICU for acute pancreatitis. Our secondary objective was to describe     the management and outcomes of IPN   "
2448|NCT03253848|"     This clinical trial studies how well simplified patient care strategy works in decreasing     early death in patients with acute promyelocytic leukemia. Implementing simplified acute     promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia     experts may decrease deaths and improve survival.   "
5671|NCT03211663|"     This is a prospective, multi-center study, designed to assess mid-term performance of the     MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical     findings and radiographic analysis.   "
2449|NCT03253835|"     Various factors affect the performance of the heart: The contractile properties of myocardial     muscle cells are the fundamental devices for translating tension-generation and shortening of     the cardiac muscle into pressure-generation and blood volume ejection from the heart into the     body. On the other hand, the performance of heart can be analyzed with respect to input and     output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance     of a pump: With every heartbeat blood is sucked from a low-pressure system (veins) and pumped     to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood     volume, blood flow and pressures are linked by hemodynamic laws.      Cardiac magnetic resonance (CMR) is the gold standard technique to determine cardiac     function and muscle mass, as well as for non-invasive diagnosis of myocardial     necrosis/fibrosis. Furthermore, new CMR imaging techniques enabling the measurement of     myocardial magnetic relaxation times for characterization of myocardial morphology and the     acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and     surrounding vessels, represent promising tools for the evaluation of the interaction between     myocardial morphology and cardiac function.      Aim of this explorative study is to 1. identify myocardial pathology-associated blood flow     patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood     flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation     dynamics …) with myocardial injuries.   "
2450|NCT03253822|"     The aim of the trial is to test the effect of a web-based decision aid (DA) on colorectal     cancer (CRC) knowledge, decisional conflict, participation rate, and informed choice     (evaluated based on knowledge, attitudes and actual participation).      The study includes three study arms. Citizens to be recruited are identified from the Danish     Civil Registration System based on residence (Central Denmark Region), age (50-74 years old),     and month of birth. A random sample of 15,000 citizens born in December (invited for CRC     screening through October/November/December 2017) (study arm 1+2) and 5,000 citizens born in     October (invited for CRC screening in January/February 2017) (study arm 3) is identified.      Citizens in study arm 1+2 will receive a baseline questionnaire assessing knowledge,     attitudes, worry, and health literacy. Non respondents will receive one reminder after two     weeks and after four weeks non-respondents will receive a phone call, offering them to fill     out the questionnaire via the phone. Baseline questionnaire respondents are included in the     study, and will be randomized into two study arms (intervention group and control group).      Citizens in the intervention group will be identified in the screening IT system. Date of     screening invitation and screening reminder (citizens who do not return a stool sample within     45 days of the screening invitation) is retrieved. Citizens receiving a screening reminder     will receive a link for the DA. Follow-up questionnaire will be sent to all included citizens     in study-arm 1+2 three months after the last screening invitation has been sent out. Citizens     have six weeks to respond to the questionnaire.      Study arm 3 is a historic cohort. The citizens receive only one questionnaire at the same     time as the baseline questionnaires are sent out to the intervention and control groups. The     citizens are included if they respond to the questionnaire within six weeks. Questionnaire     reminders are sent out at two and four weeks.      Data on screening invitation date, screening reminder date, returning a stool sample and     result will be retrieved from the screening IT system for all included citizens (Study arm     1-3). Lastly, data from Statistics Denmark (on socio-demographic and socio-economic factors)     will be included.   "
2451|NCT03253809|"     LV pacing at various sites with recording of ECG and subsequent signal analysis at different     sites.   "
2453|NCT03253783|"     This study uses a randomized controlled design to evaluate the efficacy of a new mobile app,     Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based     mobile health application that can be accessed through mobile smartphones and computers.     Pulse was designed to increase highly effective birth control use and reproductive and sexual     health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of     women with the following characteristics at study enrollment: aged 18-20, not pregnant or     trying to become pregnant, has daily access to a smartphone, currently living in the United     States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at     least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to     enroll up to 1,300 participants over a one-year enrollment period using social media,     including Facebook, Instagram, and Twitter.      Users access Pulse autonomously, on their own terms, and in their own time and place. The app     consists of 6 sections and includes 3 hours of unique content. It does not require the user     to follow a specific sequence of content viewed; however, all users will receive a monetary     incentive after registering with the apps. Youth randomized to the intervention condition are     given access to Pulse indefinitely and receive daily text messages related to sexual health     for 6 weeks. Control participants are directed to a free general health/fitness web-based     mobile application, also called Pulse, and receive text messages related to general health     for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain     different content. Participants in both the intervention and comparison groups receive a     baseline survey and a 6-week follow-up survey. Participants will also receive incentives once     they complete the baseline and post-intervention survey. Both surveys are conducted online     via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of     New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of     Health and Human Services' Office of Adolescent Health.   "
2454|NCT03253770|"     Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX,     accepted for publication BJA) clearly showed that it could not be compared to other urgent     and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local     anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly     improved with the help of a digital cognitive aid.      The present study exclusively deals with the management of cardiac arrest (recovery ward, or     in the delivery room.) with the second generation of our digital cognitive aid, and explores     new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand     of the leader.   "
2455|NCT03253757|"     HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people     in order to prevent them from becoming HIV positive if exposed to HIV.      Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe     for use as HIV PrEP. We know from previous studies worldwide that this combination drug is     very good at reducing the risk of HIV infection and several countries have implemented PrEP     programmes to provide PrEP to individuals at high risk of HIV.      However, it is difficult to effectively plan for a national PrEP programme in England without     knowing how many people will need PrEP, how many will want to take PrEP, and how long they     will stay on PrEP.      In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000     people over three years. HIV negative men and women attending sexual health clinics in     England will have their risk of HIV assessed by their care team and be offered PrEP if they     meet the eligibility criteria. Through the trial we will be able to measure how many     attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take     up the offer of PrEP and how long they remain on PrEP for.      There will not be any additional tests other than those recommended for the safe delivery of     PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine     and blood tests to monitor kidney function. Information about attendances and test results     will be anonymously collected through the existing data reporting system that sexual health     clinics currently use to report to Public Health England.   "
2468|NCT03253588|"     Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy.     We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery     in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the     fertility outcome of the patients, as well as to identify the factors predicting the presence     of persistent ectopic pregnancy after the surgery.   "
2463|NCT03253653|"     Waterpipe smoking is a tobacco use method in which smoke passes through a partially-filled     water jar. Burning charcoal heats the waterpipe tobacco which produces the smoke that the     user inhales. Waterpipe smoking was associated with increased risk for coronary heart and     pulmonary diseases. This Waterpipe Study will inform the FDA on regulating waterpipe tobacco     products and reduce the harm of it use. This study will be conducted at homes of hookah     smokers, in natural settings, aimed to determine the effects of waterpipe smoking practices     on physiological injury markers and biomarkers of toxicity of waterpipe tobacco smoking. The     investigators will employ a repeated measures design. The investigators will recruit a sample     of 50 adult male and female exclusive waterpipe smokers and a control sample of 25 male and     female non-smokers via intercept interviews from San Diego County, California communities.     Waterpipe smokers will smoke one waterpipe tobacco head (10g) of Starbuzz during 3 separate     sessions with a 7-day washout period before each session, as follows: Session 1, Smoking     waterpipe tobacco using 1 quick-light charcoal and room temperature water in the waterpipe     jar, Session 2, Smoking waterpipe tobacco using 1 quick-light charcoal and adding ice cubes     to the water in the waterpipe jar, and Session 3, Smoking waterpipe tobacco without charcoal     using a charcoal-free electrically heated waterpipe head to heat the tobacco, and room     temperature water in the waterpipe jar. The following data will be collected: a) Tobacco Use     History, b) 4-week Tobacco Exposure Diary, c) Waterpipe Use Session Form, d) Carbon monoxide     (CO) exposure: Micro+ Smokerlyzer® CO monitor will be used for exhaled CO pre and 2 minutes     post each smoking session, e) Pulmonary function testing and measuring blood pressure, heart     rate and respiratory rate, and f) 6 first morning urine samples: pre and post the 3 sessions     to measure urinary cotinine, a metabolite of nicotine, 4-(methylnitrosamino)-1-     (3-pyridyl)-1-butanol (NNAL) and NNAL-glucuronides (total NNAL), metabolites of the lung     carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), 1-hydroxypyrene (1-HOP), a     metabolite of the genotoxic carcinogen pyrene, and S-phenylmercapturic acid (SPMA), a     metabolite of the human hematotoxicant and leukemogen benzene. The investigators will explore     exposure levels to furan, a liver toxicant and carcinogen, among waterpipe smokers via     measuring its urinary metabolite Furan-BDA-NAL.   "
2464|NCT03253640|"     This study will investigate the cost and impact of Healthcare Associated Infection (HAI) to     patients, the health service and the wider community.      This is in order to develop a model to allow policy makers to compare the cost effectiveness     of Infection Prevention and Control measures in NHSScotland. The model will support policy     makers and clinical teams in building a patient centred, safe, effective and efficient     service.   "
2465|NCT03253627|"     This study will use non-invasive neuroimaging (i.e., MRI) to examine whether     Mindfulness-Based Stress Reduction (MBSR) improves neural markers of cognitive function for     postmenopausal women taking aromatase inhibitor (AI) therapy for breast cancer. The pilot     randomized controlled trial will obtain preliminary efficacy of MBSR versus Health     Enhancement Program (HEP) active control to improve neural markers of cognitive function. The     final sample will include 32 postmenopausal women with breast cancer. MBSR and HEP groups     will meet for a matched schedule of 8 weekly 2.5-hour sessions and a one-day weekend retreat.     Specimen and data collection will be done at three time points: pre-randomization (i.e.,     within three weeks before beginning the intervention), within three weeks after completion of     the intervention, and approximately three months (+/- three weeks) post intervention. Change     scores for neuroimaging parameter estimates will be correlated with change scores for     measures of cognitive function and affect. Differential expression of genes will be     correlated with neuroimaging parameter estimates.   "
2466|NCT03253614|"     Gentamicin, in combination with a beta-lactam antibiotic, is commonly used for treatment of     neonatal sepsis. Neonates have a high volume of distribution. It is a paradox that most     neonatal dosing schedules still recommend lower gentamicin doses (4-5 mg/kg) than in older     children (≥ 7 mg/kg). In the neonatal unit in Tromsø a simplified gentamicin high-dose (6     mg/kg) regimen has been in use since 2004.      The investigators have previously shown that this regimen was associated with low number of     elevated trough levels, low numbers of prescription errors and no evidence for ototoxicity in     the immediate neonatal period. However, the long-term safety of gentamicin therapy in     neonates is not well studied when it comes to ototoxicity and possible nephrotoxicity.      The objective of the current study is therefore to perform a detailed hearing evaluation,     including an extended high-frequency (EHF; 9-16 kHz) audiometry, in a follow-up study of     children (participants) aged 6-15 years who were exposed to a high-dose gentamicin regimen in     the neonatal period. Moreover, we will investigate blood pressure and urine biomarkers to     assess renal tubular function. The aim is to include 250 children exposed to gentamicin in     the neonatal period and a control group of 25 healthy children.      EHF audiometry is a more sensitive method for detecting ototoxic damage and provides evidence     of ototoxicity before any hearing loss is detected by conventional systems. This is the     background for choice of method.      The primary outcome is the difference in average hearing threshold in the EHF range between     the control group and the exposed group.      Secondary outcomes are i) difference in average hearing threshold in the EHF range between     the children with gentamicin trough levels > 1.0 mg/L versus those who had lower trough     levels, ii) markers of renal tubular function (kidney injury molecule 1) and iii) blood     pressure.   "
2467|NCT03253601|"     Adherence to rehabilitation interventions is associated with functional outcomes (e.g.     independence in daily activities, return of motor function) after stroke. Low adherence to     rehabilitation home programs is common after stroke. Interventions delivered via mobile     health applications demonstrated positive effects on adherence to health behaviors (e.g.     medication routines, smoking cessation). The investigators developed the iADAPTS mobile     application to support adherence to Strategy Training. Strategy Training is an iterative     rehabilitation intervention the promotes goal setting, planning, and self-monitoring after     stroke. This study examines the effects of the iADAPTS mobile health application relative to     a workbook on adherence to Strategy Training after stroke.   "
2844|NCT03248687|"     The investigators will be enrolling children with distal radius buckle fractures, treating     them with a removable splint and randomizing them to follow up as needed vs required follow     up with a primary care physician 1-2 weeks after the ED visit.   "
2473|NCT03253523|"     Occipital neuralgia and subsequent headaches are associated with significant morbidity and     impact quality of life and ability to work. Treatment is primarily medical and consists of     non-steroidal anti-inflammatory medications and medications to treat neuropathic pain. Many     patient exhaust medical management options and suffer from persistent symptoms.      Surgical management of chronic headaches including occipital neuralgia is emerging as a tool     to relieve pain and the burden of morbidity associated with this condition. Dr. Bahman     Guyuron has been reporting positive results in the literature for the past 20 years. In a     systematic review of 14 papers it has been demonstrated that peripheral nerve surgery for     migraines is effective and leads to an improvement of symptoms for 86% of patients.     Complication rates were low across all studies included. Additionally, Dr Ivica Ducic has     reported success specifically treating occipital neuralgia headaches, with significant     improvements in subjective pain outcomes post-operatively. The mechanism behind this is     thought to be similar to carpal tunnel syndrome, whereby peripheral nerve compression causes     nerve irritation and pain. The ensuing inflammatory response to tissue injury can cause     sensitization of nociceptors, resulting in hyperalgesia or allodynia. Surgical release of     tight surrounding soft tissues results in nerve decompression and relief of symptoms.      Although there are multiple case series and empiric evidence supporting the safety and     efficacy of occipital migraine surgery, there are no randomized controlled studies comparing     surgical intervention with continued medical management.      As part of the present study, the investigators intend to randomize patients who have     exhausted maximal medical treatment of post-traumatic occipital headaches to either a     surgical management group or a continued medical management group. Surgical intervention will     consist of neurolysis, or release, of the occipital nerves.   "
2474|NCT03253510|"     Randomized clinical trial to compare between biting force of mandibular complete denture     constructed from two different materials; metal reinforced polyamide and conventional     PMMA,The null hypothesis of the study that there will not be a difference between biting     force of the complete denture constructed from metal reinforced polyamide and PMMA   "
28205|NCT02916498|"     The study aims to better understand how to program Spinal Cord Stimulation for the treatment     of chronic low back and leg pain   "
2475|NCT03253497|"     The use of laryngeal mask (LMA) for the purpose of providing airway safety of patients is a     common method in general anesthesia practice. This practice does not require laryngoscopy and     there is no laryngeal and tracheal stimulation until endotracheal intubation, so an increased     hemodynamic response is not expected in the patient. LMA is an airway control device     consisting of a silicon mask commonly used in cases where endotracheal intubation (ETE) is     not required and a silicone tubing connected by 30 degrees. The glottic settles around the     entrance. There is no obligation for muscle relaxation as LMA is intubated. However, if a     muscle relaxant agent is not used, pharyngolaryngeal side effects such as patient wounds,     hiccups, coughs, involuntary muscle movement, hypoxia, laryngospasm can be seen when LMA is     inserted. In these patients complications such as throat burning, sore throat, ear pain,     voice anxiety, swallowing difficulties are seen depending on the difficulty of LMA placement     in the postoperative period.      Benzidamine is an anti-inflammatory analgesic agent that is not related to the steroid group     as the structure. Benzidamine is different from other non-steroidal anti-inflammatory agents     in terms of base formation. Benzidamine has local anesthetic effect in concentrations used in     topical treatment. Chlorhexidine grams (+) gram (-) bacteria are most effective in     microorganisms such as yeast and some fungi and viruses. Chlorhexidine delays bacterial     spread with delayed surface effect. It is absorptive from the microbial cell walls and causes     membrane leakage.      In this study, investigators aimed to reveal the effects of topical chlorhexidine and     benzidamine containing spray (chlorobenzene 30 Ml Spray) used before LMA placement on     hemodynamic response with postoperative throat and ear pain, swallowing difficulty, voice     anxiety and soft LMA removal.   "
2476|NCT03253484|"     The primary objective of this study is to explore the potential clinical effect of targeting     surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to     reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1)     inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding,     2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3)     remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.   "
2477|NCT03253471|"     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,     tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally     administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3).      Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from     Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per     their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects     with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)   "
2478|NCT03253458|"     The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a     significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence     Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging.     The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further     improve prostate cancer detection and provides a real-time histopathological threedimensional     representation of the tumor lesions.      This is an investigator-initiated, prospective in-vivo safety and feasibility study with     transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in     prostate tissue.   "
2479|NCT03253445|"     The purpose of this study is to evaluate the efficacy of using Acceptance and commitment     therapy for smoking cessation for schizophrenic patients.   "
2480|NCT03253432|"     The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a     clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national     initiative that utilizes machine learning and data mining techniques to identify individuals     whose profiles are consistent with FH patients. The algorithm will be tested in adults with     at least one cardiovascular comorbidity. Study subjects will be asked to provide either a     saliva, buccal or venous blood sample for DNA and biomarker analysis   "
2481|NCT03253419|"     The purpose of this research study is to examine home safety and fall risk for patients who     have undergone hip replacement surgery. The investigators want to know whether evaluating     home safety impacts perceived and real risk of falls at home. The study will utilize a fall     risk assessment which is a questionnaire that focuses on perceived and real risk of falls at     home, as well as a home safety assessment application, the Home for Life App. The participant     will be asked about the home environment, including areas of the home such as the entrance,     bedroom, and bathroom, and modification recommendations will be made to potentially increase     safety.   "
2482|NCT03253406|"     The purpose of this pilot randomized trial is to determine (1) the effectiveness of the Polar     M400, used in combination with a twice-weekly Facebook-delivered Social Cognitive     Theory-based health intervention, in the promotion of more healthful physical activity and     nutritious eating behaviors over 12 weeks in college students versus a comparison group; and     (2) the validity and reliability of the Polar M400 in the assessment of free-living (i.e.,     non-laboratory based) physical activity (in this case, steps per day and daily durations of     moderate and vigorous physical activity) and energy expenditure.   "
2613|NCT03251703|"     Shoulder pain is the second most common musculoskeletal disease in adults, and it often     becomes chronic due to treatment difficulties.      Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of     chronic shoulder pain due to its long duration of action and non-destructive method.   "
2483|NCT03253393|"     This study is a randomized, contralateral, investigator-masked non-dispensing study, to     investigate the microbial contamination rates on the back surface of soft contact lenses     extracted from Smart Touch Technology blister packs versus conventional lens packaging after     short-term placement on the eye, and to compare the microbial contamination rates of the worn     contact lenses to those on the participants' hands/fingers used to conduct lens insertion.   "
2484|NCT03253380|"     this study aim to compare the effect of early rehabilitation program on mechanical ventilated     COPD patient in Respiratory ICU to those using current standard care as regarding :        -  morbidity and thirty day mortality        -  diaphragm function and weaning outcomes.        -  disease exacerbation        -  Duration spent on ventilator.        -  Length of ICU stay   "
2544|NCT03252600|"     This randomized phase II trial studies how well lenalidomide, dexamethasone, and eotuzumab     with or without cyclophosphamide work in treating patients with primary amyloidosis that has     come back after a period of improvement. Drugs used in chemotherapy, such as lenalidomide,     dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as eotuzumab, may interfere with the ability of cancer     cells to grow and spread. Giving lenalidomide, dexamethasone, and eotuzumab with     cyclophosphamide may work better in treating patients with primary amyloidosis.   "
2485|NCT03253367|"     Clozapine (CLZ) is generally prescribed if at least two trials of antipsychotic agents have     not led to satisfactory clinical improvement, thereby implying that patients on CLZ generally     suffer from more severe and/or persistent symptoms than patients suffering from schizophrenia     spectrum disorders (SCZ) on other antipsychotic agents. Unraveling the (functional) genetic     variation underlying this severe SCZ phenotype therefore has the potential to deepen the     understanding of the biological underpinnings of SCZ beyond the boundaries of DSM-based     consensus criteria. Such knowledge in turn has the potential to shape future     pharmacotherapeutic research. It is hypothesized that targeting this phenotype in genome-wide     association studies and next-generation sequencing studies will signal genetic risk loci     implicated in this severe SCZ phenotype. In the future, this may lead to early detection of     severe SCZ, which in turn will enable tailoring of pharmacotherapeutic strategies to such SCZ     subtypes. The results of this genetic part of the study will be combined with the results     from our other research protocol 'Phenomics and genomic of clozapine pharmacotherapy - New     Users'.The overarching goal of both projects is to create a prediction model for clozapine     outcome (response (and side effects). This model includes genetic, epigenetic and clinical     data.   "
2486|NCT03253354|"     This study will explore the effects of 3 different neurostimulation methods on swallowing     function in patients with dysphagia secondary to Parkinson's Disease   "
2487|NCT03253341|"     The purpose of this study is to test the efficacy of delivering an exercise and healthy     lifestyle program, Smart Aging, to older adults.   "
2488|NCT03253328|"     In this pilot clinical study the investigators propose to conduct a prospective, randomized,     double-blinded, placebo-controlled clinical trial for 30 days for participants with critical     limb ischemia (CLI) who undergo a major (above-knee or below-knee) lower extremity     amputation. By exploring the primary endpoints we aim to determine whether NAC can affect     amputation stump perfusion and healing. Based on preclinical data, the investigators     hypothesize that NAC will augment both amputation stump perfusion as well as healing. The     investigators will utilize the data from this trial to determine the true effect size that is     necessary for a larger clinical trial to determine the clinical efficacy of NAC is healing     surgical sites such as major lower extremity amputation stumps.   "
2489|NCT03253315|"     The pericardium is a double-walled sac containing the heart and the roots of the great     vessels. The pericardial sac has two layers, a serous visceral l layer (also known as     epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It     encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the     heart to the mediastinum, gives protection against infection and provides lubrication for the     heart. Pericardial diseases may be either isolated disease or part of a systemic disease     Diseases of the pericardium present clinically in one of several ways        -  Acute and recurrent pericarditis        -  Pericardial effusion without major hemodynamic compromise        -  Cardiac tamponade with cardiac compromise        -  Constrictive pericarditis   "
2490|NCT03253302|"     At present, surgical resection is still the main treatment for the potential cure of rectal     cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or     open surgery for some special patients is really difficult, especially for male, prostate     hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the     mesorectum and separate to the pelvic floor. While transanal total mesorectal excision     (TaTME) approach could be more directly separate the low mesorectum and relatively simple to     complete distal rectal transection, which would bring some considerable advantages. Although     active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in     China. It is urgent for clinical studies to obtain the results in China. This multicenter,     observational study will help to encourage research in this field and to obtain data on the     safety and efficacy of this procedure in Chinese patients with rectal cancer.   "
2491|NCT03253289|"     Meclizine hydrochloride is an antihistamine widely used for treatment of vertigo and motion     sickness. In HCC it has been used for anti-emetic effects, but it is used here as a CAR     (constitutive androstane receptor) inverse agonist.      The hypothesis of this study is that meclizine, a CAR inverse agonist, will have a beneficial     therapeutic effect in patients with hepatocellular carcinoma who are candidates for surgical     resection, ablation or TACE (trans-arterial chemoembolization) by blocking tumorigenesis and     inducing apoptosis.   "
2492|NCT03253276|"     This is an investigator-initiated, double-blind crossover study on the mechanism of OCA     treatment of patients with PBC.      Hypothesis and significance      The investigators will test the hypothesis that OCA administration to patients with PBC     increases hepatobiliary secretion of cholylsarcosine assessed by PET/CT using 11C-labeled     cholylsarcosine (11C-CSar) as tracer.      The results of this research project will elucidate the mechanism of the effect of using OCA     therapeutically in patients with PBC.   "
2493|NCT03253263|"     The purpose of this study is to determine if an investigational drug can reduce respiratory     complications in extremely premature babies through 12 months corrected age (CA), as compared     to extremely premature babies receiving standard neonatal care alone   "
2494|NCT03253250|"     The current study is a prospective, randomized, open, multi-center investigation. The aim of     current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the     hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can     be improved by peginterferon alfa-2a   "
2626|NCT03251534|"     This observational study is a collection of clinical and imaging data of patients with a     femoral shaft fracture treated by nails. The aim of this research is the contribution of the     EOS imaging system in the quantification of malunions.   "
2495|NCT03253237|"     Introduction and objective: The key to optimal diabetes management is tight glucose control.     Hemoglobin A1c is the gold standard to assess glycemic control but in cases of unrecognized     hypoglycemia, confusing nighttime events or in cases of large variations in blood glucose, a     haemoglobin A1c can not detect specific movement of blood glucose. Continuous glucose     monitoring (CGM) provides informations of glucose levels in a real-time format and may be     helpful for making the personalized therapy decisions desired in the era of precision     medicine. Our aim is to analyse the benefit of tracking patterns of glucose values by using     continuous glucose monitoring (CGM) in patients with T2DM in family medicine office.   "
2545|NCT03252587|"     This study will investigate BMS-986165 to assess its effects in patients with systemic lupus     erythematosus (SLE).   "
2496|NCT03253224|"     With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic     surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in     particular, has been increasing with the growing demand for improved mobility and quality of     life. Total knee arthroplasty is performed on patients with advanced and painful     osteoarthritis of the knees, but it can result in moderate to severe postoperative pain     during the recovery period.      To relieve anxiety or stress during surgery under regional anesthesia, sedation can be     provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor     agonist, and its analgesic effect has been well established in various procedures or     surgeries.      Magnesium has been reported to produce important analgesic effects including the suppression     of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine     tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties     of magnesium are believed to stem from regulation of calcium influx into the cell and     antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this     study, investigators will evaluate the reducing effect of magnesium on the post-total knee     arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.   "
2497|NCT03253211|"     This project will improve the efficiency and quality of healthcare for persons with sickle     cell disease, an under-served and at risk population by implementing a co-management model of     care. Many patients with sickle cell disease (SCD) receive care primarily from specialty     physicians and emergency departments (ED), thus resulting in a lack of primary care and a     high number of ED visits and hospitalizations. The goal is to improve PCP and SCD specialist     co-management. The overall purpose of this dissemination project is to evaluate utilization     data, as well as patient and provider reported outcomes associated with the dissemination of     a toolbox of decision support tools to PCP's and ED providers across NC and SC.   "
2498|NCT03253198|"     This study is a non-blinded randomized controlled trial comparing the use of a preoperative     mini block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine)     versus a partial single shot nerve block in subjects undergoing primary reverse or total     shoulder arthroplasty to see which is more effective in controlling surgery related pain. To     do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid     consumption will be recorded on a Pain Monitoring Sheet.   "
2499|NCT03253185|"     This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC)     or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose     regimen finding) in participants with CRC followed by Part A in participants with gastric     cancer. Part B (dose expansion) will enroll participants into separate disease specific     cohorts of CRC or gastric cancer.   "
2500|NCT03253172|"     The current high-sodium, low-potassium diet contributes to the high prevalence of high blood     pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation     are well-established. Hypertension is even more prevalent and resistant in patients with     chronic kidney disease (CKD) and contributes to further decline in kidney function. Four     recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium     intake was associated with better renal outcomes. All studies recommended an intervention     study with potassium supplementation in patients with CKD, but this has not been performed.     The aim of this study is to study the renoprotective effect of potassium supplementation in     patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate [eGFR] 15 - 45     ml/min/1.73 m2).   "
2501|NCT03253159|"     Evaluate the impact of the support in reducing postoperative adverse events in particular on     the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.   "
2502|NCT03253146|"     Sepsis is the most common cause of death in the clinical critically ill patients. We have     successfully screened the sepsis biomarkers by clinical proteomics approach and found that     Vimentin (VIM) played an important role in the occurrence and development of sepsis. However,     the exact mechanism is remaining unclear. In this study, the relationship between the changes     of peripheral circulation VIM expression and different stages of sepsis development will be     further verified in lager clinical trials, as well as the relationship between VIM expression     and apoptosis of immune cells (e.g lymphocytes) will also be clarified. This may indicate     that the role of VIM in the cell-mediated immunity apoptosis and inflammation-related     pathways. Through the implementation of this study, we can clarify the clinical value of VIM     and the mechanism of VIM-mediated immune cell apoptosis during the sepsis development from     the molecular level, and determine whether the VIM as a new target for sepsis diagnosis and     treatment.   "
2503|NCT03253133|"     This study determine the maximal tolerate dose   "
2514|NCT03252990|"     This study is designed as a prospective observational feasibility study. The investigators     will study whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased     uptake of 18F-choline on PET-MRI compared to stable plaques and whether the culprit plaque     shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques.     First, 15 NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention     (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are     currently scheduled for a second PCI at the VieCuri hospital will be included. These patients     will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+ and an     additional optical coherence tomography (OCT) examination (during the PCI procedure at the     Viecuri hospital). OCT will be performed as a reference standard to validate 18F-choline     PET-MRI for detection of vulnerable plaques in the coronary arteries. In addition, 15 NSTEMI     patients, who are scheduled for PCI of the culprit lesion at the MUMC+, will be subjected to     an additional 18F-choline PET-MRI examination at the MUMC+. Hereby, the culprit coronary     vessel and thereby the culprit plaque can be identified by the location of the myocardial     infarct, as identified by late enhanced MRI. The investigators will study whether the culprit     plaque shows an increased 18F-choline uptake on 18F-choline PET-MRI compared to non-culprit     plaques in the other coronary arteries. All patients will receive standard, guideline-based     clinical care, while PET-MRI and OCT will be performed as additional measurements. Before the     start of the study, 5 stable angina pectoris patients that are scheduled for a PCI procedure     at the MUMC+ will be included at the MUMC+ for a single PET-MRI scan to optimize the     parameters of the coronary PET-MRI scan.   "
2627|NCT03251521|"     The aim of the study was to analyze which step of the procedure of toxin botulinum injection     is the most painful between skin break-in, electric stimulation, injection and needle     withdrawal.   "
2505|NCT03253107|"     -  discovery and validation of biomarker predicting gastric cancer chemotherapy response             -  Analysis for expression level of mRNA using Next generation sequencing in gastric               cancer tissue by chemotherapy response             -  Analysis for expression level of miRNA using Next generation sequencing in gastric               cancer tissue and blood by chemotherapy response             -  Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort        -  Biological biomarkers-clinical factor combined prediction model of gastric cancer          chemotherapy response   "
37991|NCT02788370|"     Aim of this study is to compare cardiopulmonary response to conical-PEP breathing during     exercise in older people.   "
2507|NCT03253081|"     Parent-mediated interventions often target social communication in young children with ASD,     although to date studies yield inconsistent effects. One reason for the limited evidence may     be the considerable heterogeneity in both parent and child characteristics that affect the     fit of intervention to family and ultimately influence treatment outcome. For parents, these     factors might include stress associated with the uncertainty of their child's diagnosis,     caregiver expectations for the intervention itself, and a parent's own style of interaction     that may be influenced by milder but qualitatively similar ASD characteristics, known as the     broad autism phenotype (BAP). For children, these factors might include nonverbal DQ,     language, or sensory impairment. The fit between type of intervention and optimal outcome for     parent and child is an understudied, yet essential component of early intervention that may     be susceptible to the influence of heterogeneity in the parent and child. One approach to     addressing this variability is to implement an adaptive intervention approach that seeks to     capitalize on heterogeneity among children and parents. Utilizing an adaptive treatment     design, the current study tests the optimal sequence of intervention delivery and specific     parent and child characteristics that may moderate treatment success in three 10-week stages     of intervention. The first phase will randomize parents and children to a parent education     condition, consisting of a parent support and education group focused on social communication     development, or to a parent mediated and therapist delivered condition involving coaching of     the parent with their child in social communication strategies. Phase 2 involves     re-randomizing parents and children to maintain the same treatment arm, or change to the     opposite arm to test the optimal sequence of intervention delivery and specific parent and     child characteristics that may moderate treatment success. In the final phase, dyads are     randomized to different maintenance arms, each comprised of 5 sessions with one involving     skype and text contact, the other in -home visits, to explore how best to maintain treatment     gains once the active intervention phase is complete. This study has the potential to     dramatically improve child social communication outcomes by individualizing and personalizing     parent intervention approaches with very young children, a high priority need of the     Interagency Autism Coordinating Council and NIH.   "
2508|NCT03253068|"     To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in     subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus     amurubicin (AMR).   "
2509|NCT03253055|"     Athletes and active individuals have been identified as an at-risk group for a low vitamin D     status, specifically those residing in countries of higher latitude (such as the United     Kingdom). This especially applies to those who train indoors for their sport, this is because     Vitamin D is primarily produced following skin exposure to ultraviolet B (UVB) exposure.     Vitamin D is essential for the maintenance of optimal bone and musculoskeletal health. It has     also been suggested to play a role in the prevention of illness incidence, such as in upper     respiratory tract infections (URTI). More recent research has indicated that an improved     Vitamin D status may also play a role in enhancing exercise performance. Therefore, having a     poor vitamin D status could negatively impact athletic training and competition. The purpose     of this study is to evaluate the prevalence of vitamin D deficiency in university athletes     and inactive controls in spring and autumn.      During this study the subjects will be asked to visit the labs on two occasions, at the     beginning of the study for baseline measurements, and again on two occasions at the end of     the study. Participants will have the following outcomes assessed: Sport performance     (vertical jump height, muscular strength and aerobic fitness), peripheral Quantitative     Computed Tomography (pQCT) scan of the bone mineral composition of the tibia, total body     composition via Dual Energy X-ray Absorptiometry (DEXA),total and hip/femoral head bone     mineral density and content to assess fracture risk via DEXA. Serum 25(OH)D levels (≈15ml of     whole blood will be collected for these measurements. Dietary intake using self-reported food     diaries. In addition illness and injury incidence will be recorded daily throughout the study     in a booklet provided to the participants.Throughout the trial, the participants will be     contacted via telephone/ email on a monthly basis to discuss any issues and maintain good     communication.   "
2510|NCT03253042|"     The purpose of this study is to analyze the immediate and chronic effects of an exercise     protocol on the vibration platform on the functional and neuromuscular performance of lower     limbs, postural control and life quality in healthy elderly.   "
2511|NCT03253029|"     Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive     effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body     mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment     (BIA).   "
2512|NCT03253016|"     A comparative evaluation to evaluate the correlation between cervical cerclage or vaginal     progesterone and maternal vaginal microbiome distribution during pregnancy   "
2513|NCT03253003|"     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted     on hard of participants with a hearing loss to grant quality control prior to product launch.     The aim of the investigation series is to ensure a stable overall performance of the new     hearing systems, a good sound quality during phone calls as well as maximum benefit for the     participant with the devices.   "
2537|NCT03252691|"     Lumbar discectomy study, collection and evaluation of incidence of large annular defects.   "
2515|NCT03252977|"     Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for     postoperative pain control. However, effective pain control with minimized side effects of     analgesic agents is still challenging. Several studies reported that preoperative pain     sensitivity measured by quantitative sensory test could predict postoperative pain.     Therefore, the investigators planned this trial to evaluate the effectiveness of tailored     patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain     threshold in patients undergoing gynecological surgery.   "
2516|NCT03252964|"     This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor     (CGM) as part of an educational program designed to help them better manage their glucose     levels. Subjects will also wear an activity tracker to monitor their activity and observe its     effect on their glucose levels. The educational program will involve calls from coaches to     check subjects' progress and answer questions.   "
2517|NCT03252951|"     Anal incontinence is a significant public health problem estimated to affect 7-15% of women     in the United States. Traditional rehabilitation strategies include biofeedback and Kegel     exercises for pelvic floor muscle strengthening, but this strategy does not incorporate     strategies for resistance training that are known to cause muscle strengthening and     hypertrophy in other muscles in the body. This study aims to investigate whether a novel     pelvic floor resistance exercise program will increase pelvic floor muscle strength and     improve anal incontinence and has the potential to impact rehabilitation strategies for the     millions of women affected anal incontinence.   "
2518|NCT03252938|"     This phase I trial aims to investigate a potential enhancement of IMP321 immune-activating     effects by new routes of administration: direct injection of IMP321 into the tumor tissue;     intra-peritoneal therapy; combination of chemotherapy with active immunotherapy     (chemo-immunotherapy)   "
2519|NCT03252925|"     HSCT associated thrombotic microangiopathy(TA-TMA) is a heterogeneous, fatal disorder seen     within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal     failure, mental status changes and involvement of other organs. N-Acetylcysteine (NAC) is a     small, simple molecule that began as a generic drug almost 40 years ago. It has since been     approved by the FDA for many indications. The investigators conducted an prospective clinical     trial to evaluate the safety and efficiency of NAC in patients with TA-TMA.   "
44430|NCT02704143|"     The safety and efficacy of combination of SBRT with Cyberknife with S-1 in treating     pancreatic cancer will be evaluated.   "
2520|NCT03252912|"     Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain     parenchymal metastases, the incidence of LM seems to be increasing, due to the growing     incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic     agents into the central nervous system (CNS). Several prognostic factors have been     identified, including the age at diagnosis, the functional and neurological status, the delay     between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6     months in most published series. Several neuronal biomarkers could also be good candidates,     such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to     be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in     several neurological diseases including Alzheimer's disease, Parkinson's disease, amyotrophic     lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation     of a clinico-biological collection seems to be of high value in order to investigate future     biomarkers of interest   "
2521|NCT03252899|"     A survey was conducted among physiotherapists and occupational therapists working with stroke     patients. The survey consisted out of 30 questions enquiring personal information and upper     limb specific topics divided in 3 sections: (1) Passive mobilization, (2) Active exercises     and (3) Immobilization. The survey took approximately 20 to 30 minutes to complete.      The survey for stroke survivors was divided in seven sections: (1) Personal information (2)     Motor recovery of the upper limb and expectations on upper limb recovery; (3) Comfort, pain     and quality of life (QoL); (4) Immobilization ; (5) Physiotherapy; (6) Occupational therapy;     (7) Nursing (only for patients less than 6 months after stroke). The length to complete the     survey was also organized to be achieved in 20 to 30 minutes.   "
2522|NCT03252886|"     This is a clinical study based on collected video-clip data of CPR patients with suspected     neck injury in multiple trauma between 2011-2015. The study aimed to compare all possible     factors relating to ETI performance during CPR for truma patients between experienced     videolaryngoscopy (VL) and direct laryngoscopy (DL) users.   "
2523|NCT03252873|"     Investigators will compare the factors affecting the adherence to the outpatient pulmonary     rehabilitation program in COPD patients   "
2524|NCT03252860|"     The investigators set out to determine the extent of compliance with the World Health     Organization Surgical Safety Checklist and the association of this compliance with     perioperative surgical outcomes in five of Uganda's referral hospitals.   "
2525|NCT03252847|"     A clinical trial of AAV2 vector for patients with X-linked retinitis pigmentosa (XLRP)   "
2526|NCT03252834|"     This is a prospective, single arm, single center study evaluating the use of a 4-gene panel     to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial     and ovarian cancer patients receiving post-operative chemotherapy with     Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant     chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July~ 2019     June. Blood sample will be collected before chemotherapy to analyze the genetic variants of     TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative     Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D & CIPN20). The     primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and     ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in     cancer patients.   "
2538|NCT03252678|"     This study verifies efficacy of Self-education program for advanced care planning. Half of     participants will receive a book and videos about advanced care planning while the other half     will receive a book and videos about pain control for cancer patients.   "
2539|NCT03252665|"     The study intends to evaluate the efficacy of different medicine delivering by targed     perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical     outcomes in STEMI patients undergoing primary PCI.   "
2540|NCT03252652|"     the study will be carried out to standardize normal parameters of vascular duplex ultrasound     of the cranial vessels in the Egyptian population.   "
2527|NCT03252821|"     The aim of this study is to assess the impact of a high-intensity aerobic training and     resistance training on fatigue in prostate, head and neck and rectum cancer patients     undergoing radiotherapy.      A three-arm randomized controlled trial will be conducted. Patients will be randomised into     either a high-intensity aerobic training group or a resistance training group or a control     group. Participants in the training groups will exercised for five to eight weeks. Exercise     sessions will be take place 3 days per week under the supervision of an experienced     therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome     will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will     be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence     syndrome, insomnia, depression symptoms.   "
2528|NCT03252808|"     The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in     combination with chemotherapy (Gemcitabine + Nab-paclitaxel) in Japanese patients with stage     III or IV unresectable pancreatic cancer.   "
2529|NCT03252795|"     Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to     freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.   "
2546|NCT03252574|"     The primary objective is to evaluate the physiological impact of AIR+ Smart Masks on     end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary     outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate     (HR) and respiratory rate (RR). In addition, we will assess the general well-being and     comfort level of the child when wearing the AIR+Smart Mask with and without micro-ventilator.   "
2565|NCT03252327|"     Frequent pain and distress may affect infants' brain and neural development, and highlight     the need for relieve pain interventions. Peripheral venous puncture procedures are an     important source of preterm infants' pain and distress. Brain development is mainly created     by infant sensory experience. It becomes important, therefore, to relieve preterm infants'     pain and distress using multiple sensory integrations during peripheral venous puncture     procedures.The proposed 2-year study has specific aim: to compare the effects of different     combination of sensory integrations on preterm infants' pain and distress before, during, and     after peripheral venous puncture procedures.   "
2566|NCT03252314|"     To determine safety and occlusion rates when second-generation hydrogel coils are used in the     treatment of ruptured intracranial aneurysms.   "
2530|NCT03252782|"     The correction of Class II malocclusion is one of the most common problems facing the     orthodontist, with an estimated one-third of all orthodontic patients treated for this     condition. Many strategies are available for Class II treatment on growing patients, and most     orthodontists tend to choose a treatment protocol based on what part of the craniofacial     deformity they believe the appliance will affect the most. A number of authors have described     the dentoalveolar and skeletal changes induced by the Herbst appliance. The dentoalveolar     effects consist of distalization of the maxillary molars and forward movement of the     mandibular dentition. The main skeletal change mandibular stimulation is acceleration of a     patient's inherent mandibular growth rather than increased growth beyond what would occur     without treatment. Maxillary molar distalization, is one of the Class II treatment.     Mini-implants have become popular in recent years, and various kinds of mini-implant-borne     distalization approaches have been described. Because Class II correction appears to be     achievable with either appliance, a follow-up question is whether there is a difference in     the esthetic outcomes. However, because of the complexity of the human face and the     subjectivity of facial beauty, a simple set of measures of lines or angles cannot quantify     facial beauty. With the advances in 3-dimensional imaging, it is now possible to capture and     superimpose digital images and measure the changes in the soft tissues from 3-dimensional     images. Such advances in facial imaging allow a more thorough investigation of changes in 3     dimensions and prevent the inherent loss of information that results from 2-dimensional     imaging. Optical scanners with short shutter speeds are convenient for clinicians and     patients for capturing soft-tissue records. Bearing in mind that the aim of orthodontic     treatment is to achieve facial harmony along with excellent occlusion, one of the most     important objectives of an orthodontist should be the improvement of facial appearance.     Therefore, it is important to gain a better understanding of how or whether orthodontic     procedures affect the appearance of the soft tissues. Thus, the aim of this clinical trial is     three dimensional evaluation of soft tissue facial changes on late mixed dentition patients     following maxillary arch distalization with palatal screws one group and acrylic split herbst     patients on other group and to compare these changes.   "
2531|NCT03252769|"     Cervical cytology screening coverage in Northern Ireland (the proportion of eligible women,     aged 25-64 years who have had a test result recorded in the previous five years) has     increased steadily since 2005 to 78% in 2012/2013; almost reaching the 80% coverage target.     The uptake of cervical screening among women in the 25-29 year age group in Northern Ireland     however, has remained consistently lower (70-73%) than all other age groups except for the     60-64 year age group where the coverage rate is similar. The main barriers preventing women     from attending for cervical screening are: embarrassment; inconvenience; time and discomfort     associated with obtaining cervical samples. Studies have shown that offering women the     opportunity to collect a vaginal self-sample to test for HPV (the main risk factor for     cervical cancer) could increase screening coverage. Non-attenders in the Western and Belfast     Health and Social Care Trust area, aged 25-29 years, will be identified by GPs. Letters with     information relating to the study and collection devices will be sent to women giving them     two options: 1. inviting them to book a normal screening appointment; 2. inviting them to     collect a self-sample for HPV testing with either a swab or brush collection device.     Participants for receipt of swab or brush will be randomised. Acceptance to participate in     the study will be indicated by signed consent. Returned self-collected samples will be HPV     tested. If a sample is negative, no further investigation is required and the woman will be     encouraged to accept her next screening invitation. If a sample is positive the woman will be     encouraged to book a screening appointment. The study will evaluate: impact on screening     uptake, acceptance of self-sampling for both devices, practicality and cost-effectiveness of     the intervention.   "
2532|NCT03252756|"     The goal of the proposed project is to begin rigorous study of the clinically relevant     effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe     alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is     designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD     to those of placebo in AUD patients. Participants with AUD will be randomized to receive     either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO)     for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD     levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include     circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and     motoric function), and physiological and psychological domains relevant to AUD (including     self-reported craving, depression, and anxiety, and responses to personalized scripts     designed to elicit stress- and cue-induced craving and anxiety). Assessments will be     conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs.     placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks     of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.   "
2533|NCT03252743|"     This open trial aims to evaluate feasibility and preliminary effectiveness of an     internet-delivered CBT-program for children and adolescents with functional gastrointestinal     disorders when implemented in regular care.   "
2534|NCT03252730|"     The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist.     Additional objectives of this clinical in-use study are to evaluate the cosmetic features and     acceptance of the product by means of a questionnaire in an interview situation and by skin     hydration measurements on the scalp.   "
2535|NCT03252717|"     To confirm the protein expression level in radiation-induced late effects patients and to     determine the performance value, in particular the positive predictive value, of a blood test     based on the dosage of a panel of five proteins, it is necessary to validate these     preliminary results by a prospective study on a large cohort of patients.   "
2536|NCT03252704|"     This randomized, double-blind, comparator controlled trial evaluated the blood glucose and     insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.   "
2542|NCT03252626|"     Ischemic stroke has a variety of treatments and currently drug therapy is one of the main     treatments.A number of clinical studies have proved that alprostadil (PGE1) has     pharmacological effects of significant dilation of blood vessels, inhibition of plate     aggregation, anti-atherosclerosis and increased cerebral blood flow.Evaluate the 90-days     efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mRS.   "
2543|NCT03252613|"     This translational study will assess the association between septic cardiomyopathy (measured     via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and     (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.   "
2562|NCT03252366|"     using gel foam [ absorbable gelatin ] in maxillary sinus elevation which act as a space     maintainer and alternative to bone filler for new bone formation in the maxillary sinus and     its advantages for patients undergoing maxillary sinus elevation with simultaneous implant     placement as regards the implant stability and amount of bone height gain compared to     conventional maxillary sinus elevation by xenograft.   "
4581|NCT03225885|"     This study evaluates the effectiveness of prenatal counseling when verbal counseling is     supplemented with a multi-media mobile application versus a written gestational age handout.   "
2547|NCT03252561|"     Laparoscopic (key-hole) appendicectomy is a minimally invasive procedure when compared to     open large bowel resection, but is still associated with a significant amount of pain and     discomfort. Analgesia is commonly provided by a multi-modal technique involving varying     combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional     analgesia and oral or parenteral opioids. Opioids are associated with an increased incidence     of nausea, vomiting and sedation which can complicate post-operative recovery. Different     techniques of intraoperative infiltration of local anaesthetic to control postoperative pain     are also being used. Their perceived benefits are thought to relate to reduced opioid     consumption and therefore reduced opioid side effects.      Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain     sensation from the abdominal wall and provides effective and safe analgesia with minimal     systemic side effects. Their perceived benefits are thought to relate to reduced opioid     consumption and therefore reduced opioid side effects. The investigators believe ultrasound     guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient     satisfaction, a reduction in post-operative nausea and vomiting and earlier hospital     discharge.      The key research question the investigators are trying to answer is whether TAP block provide     better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both     techniques are currently being used in the investigator's hospital.   "
2548|NCT03252548|"     This study is a prospective cohort study of children diagnosed with primary immunodeficiency     disease (PID). The aim is to investigate the clinical characteristics and prognosis of PID in     Chinese children.   "
2549|NCT03252535|"     Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase     II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test     doses of Cellavita HD product.   "
2550|NCT03252522|"     This proposed research will use randomized control trial (RCT) methodology and compare     micronutrients with placebo in 120 children with ADHD.   "
2551|NCT03252509|"     This study intends to evaluate the security and success rate of large bore percutaneous     radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure.   "
2552|NCT03252496|"     This study will compare between combination of colloids/crystalloids and crystalloids in     women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia   "
2553|NCT03252483|"     This randomized controlled trial was implemented to evaluate the effect of integrating rapid     Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency     Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults     in a New York City Emergency Department participated in the study. Participants were     randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public     Health Advocates approached eligible patients in the Emergency Department, performed HIV and     HCV raid testing, and delivered test results to participants with post-test counseling. The     primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether     the addition of an HCV test adversely impacted participants' consent to test for HIV.     Questionnaires were also distributed to participants to assess HCV knowledge.   "
2554|NCT03252470|"     This is a hypothesis generating pilot study to compare the impact of 2D versus 3D     visualization on surgical performance, as measured by the OR BlackBox platform, during     laparoscopic bariatric surgery.   "
2556|NCT03252444|"     The investigators will test whether conscious control with manual guides and video or EMG     biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with     different type of scapula dyskinesis. The investigators will also examine how correction of     scapular orientation may affect the activation of associated muscles during various dynamic     movements in these subjects.   "
2557|NCT03252431|"     This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3     study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive     breast cancer receiving chemotherapy treatment.   "
2628|NCT03251508|"     The purpose of this trial is to provide salvage peanut oral immunotherapy for patients with     peanut allergy.   "
2558|NCT03252418|"     Vitamin C affect the melanocytes function not the number while diode laser cause melanocytes     destruction. Although diode laser and vitamin C have proved their effectiveness in     depigmentation in previous studies, there are no published studies compared the effect of     diode laser and vitamin C on melanocytes and melanosomes clinically and histologically.   "
2559|NCT03252405|"     To compare the effect of two different induction method; mask ventilation and intravenous     cannulation on emergence agitation on pediatric adenotonsillectomy   "
2560|NCT03252392|"     Co morbidity rates of hearing loss in children with autism spectrum disorder are high and     increasing.      Investigators are aiming to:        1. evaluate peripheral auditory and brain stem auditory function in children with autism          spectrum disorder.        2. compare communication capabilities in autistic children having hearing abnormalities and          autistic children with normal hearing.   "
2561|NCT03252379|"     Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons     for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD     strictures, choledochal cysts and biliary tract tumors management. The incidence of     anastomotic stricture following hepaticojejunostomy in experienced centers ranges between     5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if     untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary     cirrhosis, hepatic failure and eventually death.      Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made     difficult by the sequelae of long-standing unrelieved biliary obstruction like portal     hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of     cholangiolytic liver abscess.      Endoscopic management is not only the least invasive but also very effective via either     balloon dilatation or stenting of the stricture. In patients with Roux-en-Y     hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance     traveled by the jejunal loop until reaching the angle of the enteral anastomosis.      Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been     described in the literature including duodenal, gastric and subcutaneous access loops.      Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric     access loop. Access loop was entered easily with the gastroscope in five patients in whom it     was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different     construction of gastric access loop in the form of bilioenterogastrostomy the overall success     rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was     100% for BEG type III, which is a construction similar to the previous series (BEG) type.      Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series     of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone     extractions were all successful. In most series, the subcutaneous loop was used for     management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the     subcutaneous loop can be used as an endoscopic biliary access.   "
2567|NCT03252301|"     The trial will estimate post-operative pain management in elective surgical patients using     the PMD-200 device. The device measures physiological parameters by placing a non-invasive     sensor on a fingertip and displays an objective pain level in a 0-100 scale. The pain level     will be estimated before surgery (baseline), after surgery and during administration of     parenteral analgesia. Treatment and analgesia will be given according to clinical     considerations and standard ward protocols. The device measurements won't influence the     treatment.   "
2568|NCT03252288|"     Vaccination is a cost-effective strategy for conferring immunity against a host of     preventable diseases, however, rates of timely childhood vaccinations remain inadequate in     resource-limited settings. We propose to evaluate the feasibility and efficacy of     mHealth-assisted conditional cash transfers as a means of overcoming individual barriers to     timely vaccinations. The study will form the basis for a pragmatic randomized controlled     trial of the efficacy and cost-effectiveness of mHealth reminders and conditional cash     transfers for improving rates of timely vaccinations among young children.   "
2569|NCT03252275|"     The aim of this study is to test an intervention that has potential to improve acute care     skills and confidence related to safe delivery and newborn care for mid-level health     providers in Uganda by the development of a 'mobile' simulation package including scale-up     materials based upon research evidence. In this randomized study investigators will compare     the impact of a peer learning package on skills, knowledge and team work regarding newborn     care among health workers in rural south western Uganda.   "
2570|NCT03252262|"     The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment     system and wellness coaching program for vulnerable, low income, community dwelling older     adults, and to determine if this program is effective in promoting and sustaining     self-management skills to increase well-being and functional health among this group.     Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique     opportunity to guide elders in selecting personal goals that align with their assessment     results and develop an action plan for goal achievement. This strategy holds potential as an     effective mechanism to empower elders to implement behaviors that promote healthy aging.   "
3741|NCT03236948|"     This is an individually randomised control trial to assess the effectiveness of a livelihoods     and social empowerment intervention, delivered by Women for Women International, on married     women's experiences of intimate partner violence in Afghanistan. It has a 22 month follow up.   "
2571|NCT03252249|"     Despite substantial evidence supporting the use of dual anti-platelet therapy in patients     with acute coronary syndrome, there remains major uncertainty regarding the optimal duration     of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are     superior because the avoidance of atherothrombotic events is counterbalanced by the greater     risks of excess major bleeding with apparent increases in all-cause mortality with longer     durations. The investigators propose a Scotland-wide randomised controlled trial of 19,424     patients with acute coronary syndrome allocated to differing durations of dual anti-platelet     therapy. In collaboration with the Farr Institute, the investigators will exploit NHS     Scotland's unique and innovative electronic health record linkage infrastructure to track     duration of therapy and clinical outcomes in a real-world, real-time, efficient and highly     cost-effective trial. This has the potential to define treatment duration, settle a major     outstanding international controversy, and influence modern cardiology practice across the     world.   "
2572|NCT03252236|"     People with stroke suffer from different impairments, including the ability to dual-tasking,     increased arterial stiffness, and dysfunction of the autonomic nervous system. The decrement     in dual-tasking performance has been found among stroke survivors, and the deterioration has     been related to increased risk of fall in the population. No coherent result has been     concluded from previous studies investigating the effect of different types of exercise     training on enhancing dual-tasking performance among healthy older adults and stroke     survivors.      Increased arterial stiffness and impaired functioning of the autonomic nervous systems, which     have been associated with increased cardiovascular risk and mortality, are common in stroke     survivors. Studies have been suggesting the beneficial effects of aerobic exercise on both     decreasing arterial stiffness and regulating the autonomic nervous system among healthy older     people. However, only a few studies concerning such topic have been conducted among stroke     survivors, yet the results were inconsistent.      Tai Chi is a Chinese traditional martial art and has been employed as a rehabilitation     exercise in recent decades. Tai Chi practitioners should perform the physical movement and     plan the Tai Chi forms simultaneously. The involvement of cognitive functioning gives Tai Chi     a dual-tasking character. Prior studies demonstrated the beneficial effect of Tai Chi     training on dual-tasking performance in healthy older adults, but would the effect extend to     stroke survivors has not yet been studied.      Also, Tai Chi is considered as a mind-body exercise. It is suggested that one should keep a     relaxed status of mind and breathe gently and slowly. Moreover, Tai Chi is an exercise with     moderate intensity. These features have been found to decrease arterial stiffness and benefit     functioning of the autonomic nervous system. Indeed, studies have been showing Tai Chi     reduces arterial stiffness and improves regulation of the autonomic nervous system among     healthy population. Whether such effect can be observed in stroke survivors is still unknown.      This study aimed at investigating the effects of Tai Chi training on dual-tasking     performance, arterial stiffness, and autonomic system functioning among stroke survivors.     Given the special features of Tai Chi and its advantageous effects on the mentioned     functioning, it is expected that stroke survivors may also benefit from Tai Chi training.   "
2573|NCT03252223|"     Women with PCOS suffer from anovulation and, as a result, infertility. Efforts to clinically     induce ovulation in these women using follicle stimulating hormone (FSH) administered     subcutaneously seemingly requires prolonged administration compared to that of ovulatory     women without PCOS. The apparent differing ovarian responsiveness to FSH between PCOS and     normal women has not been carefully studied. We propose to address this issue by performing a     dose-response study and examine ovarian follicle (estrogen, E2) responses to FSH administered     subcutaneously in women with PCOS compared to responses observed in normal women.   "
2574|NCT03252210|"     This study evaluates the feasibility，accuracy and safety of Preoperative Stereoscopic     Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first     stage，participants will receive both Preoperative Stereoscopic Localization and Methylene     Blue Localization .In the second stage,participants only receive Preoperative Stereoscopic     Localization for Wedge Resection.   "
2575|NCT03252197|"     Two-dimensional ultrasound guided approach does not guarantee first attempt success on     internal jugular vein cannulation. New attachable device recently was developed for accurate     needle insertion when ultrasound is used. Our randomized parallel simulation study will     examine whether this device will improve the first attempt success rate when ultrasound     guided internal jugular vein catheterization of simulated internal jugular vein.   "
2586|NCT03252054|"     This is a cross-sectional observational study that investigates the prevalence of memory     disorders, attention disorders (suggesting delirium), and malnutrition in hospitalized older     adults (aged 70 years or over) in a tertiary care centre, using rapid screening toos     (Six-item screener for memory disorders, Months of the Year Backwards Test for delirium, and     NRS-2002 and Mini Nutritional Assessment Short Form for malnutrition).   "
2576|NCT03252184|"     The endothelial cell layer is responsible for the control of vascular homeostasis, a process     mediated by vasoconstricting and vasodilatory substances. The principal endothelium-dependent     vascular dilator is nitric oxide (NO), and the reduction of its synthesis or bioavailability     is the main cause for the development of endothelial dysfunction. The use of     photobiostimulation may be beneficial in several clinical situations. At the endothelial     level, the photostimulatory action on vascular endothelial growth factor, NO secretion,     number of capillaries and proliferation of endothelial cells is outstanding.The objective of     this study is to evaluate the effects of photobiostimulation on the arterial endothelial     function of healthy individuals. The study design will be a cross-over trial and the sample     will be composed of 12 healthy subjects selected by the eligibility criteria, and randomly     randomized according to the order of intervention of the groups. The hypothesis is that at     the end of the irradiation protocol with photobiostimulation an increase in endothelial     function and blood markers of endothelial function occurs, and no tissue temperature     variation. The research will be developed in room 709 of the Laboratory of Physiotherapy in     building II, UFCSPA. Individuals will be randomly assigned to: group 1 (energy dose of 2J),     group 2 (energy dose of 4J), group 3 (energy dose of 6J), and group 4 (placebo).   "
2577|NCT03252171|"     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell     immunotherapy in treating with GD2 positive glioma patients.   "
2578|NCT03252158|"     Background: While there is some evidence that increasing the range of healthier foods and     drinks and/or decreasing the range of less healthy options may increase healthier choices,     more work is needed to establish the reproducibility of any effect. The current study aims to     investigate the impact of altering the availability of healthier and less healthy foods and     cold beverages in hospital vending machines.      Methods: An adapted multiple treatment reversal design will be used, in which all standard     vending machines serving snack foods and/or cold beverages in one hospital in England change     the number of slots containing (i) less healthy items and (ii) healthier items over eight     4-week periods. Changes will take place in a two-step process whereby decreases are     implemented in a separate study period prior to increases in the contrasting food group.     Following a 4-week baseline period, all vending machines will be standardised to have 75%     healthier drinks and/or 25% healthier snacks (study period 1). Vending machines (n=9) will be     randomly allocated to the order in which they: (1) decrease less healthy foods and increase     healthier foods or (2) decrease healthier foods and increase less healthy foods (study     periods 2&3 and 5&6). After each decrease-increase pair, machines will return to the     standardised 75% healthier drinks and 25% healthier snacks (study periods 4 and 7). Sales     data will be obtained via records of machine restocking.      Planned Analysis: The impact of the availability intervention will be assessed in separate     linear mixed models for cold drinks and snacks, examining the impact on total energy (kcal)     purchased, per restocking interval, with random effects for vending machine.   "
2580|NCT03252132|"     This is a population-based study of type 2 diabetes patients with and without neuropathy     recruited from the Danish National Type 2 Diabetes cohort (DD2).      Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain,     muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural     instability increasing the risk of frequent falls and thereby increased morbidity and     mortality. Thus, diabetic neuropathy is associated with significant disabilities having major     impact on activities of daily living and quality of life.      The effects of resistance training on neuropathy symptoms, muscle strength and muscle     structure in patients with and with diabetic neuropathy will be examined.   "
2581|NCT03252119|"     A randomized control trial of 130 infants admitted to the paediatric high care admission ward     will be enrolled, and randomized to either high flow humidified oxygen or standard     therapy.   "
2582|NCT03252106|"     In this prospective case series study, 20 patients with an implant-borne single crown     following early implant placement with simultaneous contour augmentation will be followed for     10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone     beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and     compared to the 6 year data.   "
2583|NCT03252093|"     Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with     cognitive impairment. Mechanisms of cognitive impairment are complex but may include     insufficient oxygenation and inflammation due to exposure to the bypass circuit. Currently     there are no approved therapeutics for the prevention or treatment of cognitive impairment in     these patients.      A small peptide, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the     brain in animal models. Early studies in humans have shown it to be safe. This peptide is     naturally produced by the body and has anti-inflammatory and vasodilatory effects.     Investigators believe that Ang-(1-7) may be able to help lower the risk of cognitive     dysfunction in patients undergoing CABG.      The goal of this project is to explore effects of the experimental peptide Angiotensin-(1-7)     (Ang-(1-7) in patients undergoing an elective CABG surgery to determine its safety and     efficacy to prevent cognitive dysfunction in patients undergoing CABG.   "
2584|NCT03252080|"     Two hundreds patients with T2DM from the outpatient clinic of The First Affiliated Hospital     of Chongqing Medical University will be enrolled in this study. Participating subjects will     be randomly assigned into one of the 2 groups: Group A (n=100) will be placed on the     short-term intensive education program alone while Group B (n=100) will be placed on the     short-term intensive education as well as a holistic management for 6 months.      Diabetes education: The patients of each group will undergo designated education programs in     4 subgroups. Group A and B will be given the same education classes once a week in the first     month (total 4 times), 5 hours per class. The education classes will be taught by a dedicated     team of diabetes specialist doctors and nurses, with the contents including a basic     understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose     monitoring. At the conclusion of the education classes, the patients in Group B then will     undergo a weekly telephone interview with specialist nurses for 6 months to help patients     resolve self-management problems while patients in Group A will not. The specialist nurses     will talk individually with the patients in Group B for 10-15 min per week. The nurses will     ask the patients about their results of self-blood glucose monitoring, help them find the     reasons of poor blood glucose control as well as answer the patient's questions.      Clinical examination: All subjects will complete Audit of Diabetes Dependent Quality of Life     (ADDQoL) before education classes commence (baseline), at 3 months and 6 months (endpoint)     after education classes to evaluate their quality of life. All patients will be examined for     height, weight, blood pressure, FPG, PPG and HbA1c at baseline, 3 months after education     classes and endpoint. A diabetes specialist nurse will measure the height, weight and blood     pressure, and assist the subjects to fill the questionnaire. FPG and PPG will be determined     by the hexokinase method, while HbA1c by high performance liquid chromatography.   "
2585|NCT03252067|"     To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops     (2.5ml/25mg) in healthy volunteers.   "
2588|NCT03252028|"     Background: Due to anatomical restrictions, the inflammatory response to intra-cerebral     bacterial infections exposes swollen brain tissues to pressure and ischemia, resulting in     life-threatening damage. However, diagnosing meningitis in patients after neurosurgery is     complicated, due to brain tissue damage and changes in cerebrospinal fluid (CSF) caused by     surgery. Hepatocyte growth factor (HGF) is a local, acute-phase protein. Previous studies on     community-acquired septic meningitis reported high levels of intrathecal-produced HGF.      Aim: The aim of present study is to evaluate a new platform for qualitative determination of     HGF in body fluids and revealing the site of injury.      Method: Based on a reverse-methachromacy method, strips are prepared. The surface on the     strip changes colour to blue upon contact with HGF.      Plan: CSF, urine and sputum of patients that develop fever post neurosurgery are analysed     with the test and the results compared with conventional diagnostic methods.      Clinical value: A rapid, equipment-free test gives the opportunity to identify the infectious     focus in the infected organ long before culture results are available.   "
2589|NCT03252015|"     The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood     stream and how long it takes the body to get rid of it.      When drugs are taken together, one or all of the drugs used in combination may be affected.     This study will also evaluate how much lasmiditan and its breakdown products get into the     bloodstream after taking one dose alone and after taking lasmiditan together with a probe     drug cocktail. Information about any side effects that may occur will also be collected.      The study has two parts. Participants will only enroll in one part. This study will last     about 25 days for group1 and 22 days for group 2, not including screening. Screening is     required within 28 days prior to the start of the study.      This study is for research purposes only and is not intended to treat any medical condition.   "
2590|NCT03252002|"     To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in     healthy male subjects after a single oral dose and multiple once daily dosing for 7 days   "
2602|NCT03251846|"     A more convenient blood glucose monitoring system integrated with a responsive mobile health     app may facilitate improved diabetes control in adolescent and young adult patients with Type     1 diabetes. The primary aim of this study is to determine if the POPS diabetes management     system can improve diabetes control in the adolescent and young adult population. The     investigators hypothesize that use of the POPS diabetes management device and mobile     application (app) will be associated with lower HbA1C after 6-months of use in adolescent and     young adult T1D patients.   "
2592|NCT03251976|"     The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR)     decision aid video on CPR knowledge and end-of-life preferences in women with advanced     gynecologic malignancy. We will assess the baseline CPR knowledge in our research population,     gauge the improvement after viewing a decision aid video, and evaluate its effects on patient     preferences regarding CPR.   "
2593|NCT03251963|"     The aim of this research is to better understand how patient-level factors can be used to     predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk     reduction and minimize bleeding.   "
2594|NCT03251950|"     Food insecurity increases the risk of obesity, diabetes, hypertension, and cancer. American     Indians (AIs) in Oklahoma are three times as likely as Whites to be food-insecure (21% vs.     7%) and have burdens of obesity (42%), hypertension (38%), and diabetes (15%) that exceed     those of the general US population. While individual-level obesity prevention efforts have     been implemented with AIs, few environmental interventions to reduce food insecurity and     improve fruit and vegetable intake have been conducted with tribal communities. Community     gardening interventions have been shown to increase vegetable and fruit intake, reduce food     insecurity, and lower BMI among children and adults; however, to date, no such interventions     have been evaluated with AI families. The proposed study, entitled Food Equity Resource and     Sustainability for Health (FRESH), will assess the impact of a tribally-initiated community     gardening intervention on vegetable and fruit intake, food insecurity, BMI, and blood     pressure in families living on the Osage Nation reservation in Oklahoma.   "
2595|NCT03251937|"     To demonstrate the value of multiple modalities and sustained clinically significant pain     relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter     Spinal Cord Stimulator (SCS) System.   "
2596|NCT03251924|"     The purpose of this study is to investigate BMS-986226 administered alone or in combination     with nivolumab or ipilimumab.   "
2597|NCT03251911|"     This research study will test how well a new drug affects bronchiectasis or chronic     bronchitis. The new drug, Ivacaftor (KALYDECO), is a drug that has recently been approved by     the U.S. Food and Drug Administration (FDA) for patients with a lung disease called Cystic     Fibrosis (CF). It has not been approved for use in patients with bronchiectasis or chronic     bronchitis.   "
2598|NCT03251898|"     This study hypothesizes that early-onset neonatal Infections are related to premature rupture     of membrane (PROM) and that early intervention can improve the prognosis of newborns. The     objective of this study is to analyze the correlation between PROM and early-onset neonatal     infections and to assess the prognosis of newborns. A cohort study is designed to implement     the study. The subjects of study group are pregnant women who are diagnosed as PROM or     chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are     pregnant women without PROM and chorioamnionitis. Control group and research group are paired     at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation     between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal     infections. (3) The pathogenesis of intrauterine infection and neonatal infection.   "
2599|NCT03251885|"     The aims of the study are to evaluate the rate of ESBL-producing Enterobacteriaceae     colonization among women in preterm labor, the incidence of maternal vertical transmission of     ESBL, and the clinical significance of ESBL in preterm infants.   "
2622|NCT03251586|"     Test-Retest Reliability of ocular vestibular evoked myogenic potentials (oVEMPs) across     different electrode montages.      The purpose of this project is to compare the response characteristics of the ocular     vestibular evoked myogenic potential in patients grouped by decade (i.e. 20's-90's) using two     different recording montages and two different stimulus types (i.e. air and bone conducted     sound). The long-term goal is to increase the sensitivity and specificity of the oVEMP when     used clinically to identify vestibular disorders affecting the utricle and superior portion     of the vestibular nerve.   "
2600|NCT03251872|"     The main OBJECTIVE of this proposal is to extend our preclinical findings on the role of DNA     damage and poly(ADP-ribose) polymerases (PARP) inhibition as a therapy for a devastating     disease, pulmonary arterial hypertension (PAH), to early-phase clinical trials. We, and     others, have published strong evidence that DNA damage accounts for disease progression in     PAH and showed that PARP1 inhibition can reverse PAH in several animal models1.     Interestingly, PARP1 inhibition is also cardioprotective. Olaparib, an orally available PARP1     inhibitor, can reverse cancer growth in animals and humans with a good safety profile, and is     now approved for the treatment of ovarian cancer in Canada, Europe and the USA. The time is     thus right to translate our findings in human PAH. The industry-sponsored clinical research     on PARP1 inhibitor is currently entirely cancer-oriented. Nonetheless, AstraZeneca Canada     accepted to support an early phase clinical trial through in-kind contribution, but the     support from foundations and federal agencies is critical to catalyze early-stage development     of PARP1 inhibitors for other indications, especially for orphan diseases. A CIHR Project     Scheme grant will thus be submitted on September 15 2017, proposing a Phase 1, followed by a     Phase 2 trial that will be conducted in recognized PAH programs throughout Canada. At this     stage, however, we propose a pilot study to assess the feasibility of the proposed trials in     the PAH population. The overall HYPOTHESIS is that PARP1 inhibition with olaparib is a safe     and effective therapy for PAH.      The primary objective of the study is to confirm feasibility, to support the safety of using     olaparib in PAH patients, and precise the sample size of the coming Phase 1B trial. The     feasibility of the comprehensive patient phenotyping that will be proposed within the phase     1B trial will thus be assessed, in addition to adverse events and efficacy signals.   "
2601|NCT03251859|"     The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic     trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet     inhibition in stable patients who recently underwent acute myocardial infarction and were     treated with percutaneous coronary intervention.   "
3899|NCT03234829|"     Determination of The Combined Mesio-Distal Widths of The Permanent Mandibular Incisors and     That of The Maxillary and Mandibular Canines and Premolars in a Group of Egyptian Children in     Rural Areas of Sohag Governorate: A Cross Sectional Study   "
2603|NCT03251833|"     Body Mass Index is an index that is commonly used to classify underweight, overweight and     obesity in adults. It is defined as the weight in kilograms divided by the square of the     height in meters.The growing epidemic of obesity in our society has become a major public     health issue where the proportion of overweight and obese among women aged 15-59 have     increased from 68 percent in 2008 to 76 percent in 2015   "
2604|NCT03251820|"     Electrical status epilepticus during slow wave sleep is a condition in which the epileptic     patient starts to develop neurocognitive deterioration, any type of seizures and continuous     electrical activity in the EEG during non rapid eye movement sleep. It is an age related     condition and will resolve spontaneously at around the age of puberty. However if left     untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration.     Thus early diagnosis and treatment is essential in these children to preserve neurocognitive     function.   "
2605|NCT03251807|"     This experimental study will evaluate the effect of combined treatment with low-intensity     pulsed ultrasound (LIPUS) and functional appliances (twin-block) on the correction of class     II malocclusion, compared with the control group treated with functional appliances     (twin-block) only.      The study sample will consist of 40 patients with class II malocclusion. The sample will be     allocated randomly into two groups: control group and experimental group.      The functional appliance (twin-block) will be applied for all patients, while the     low-intensity pulsed ultrasound (LIPUS) will be applied for the experimental group only. The     skeleto-dental changes occurring after functional treatment will be assessed using     cephalometric radiographs; pre and post- treatment changes for each group will be evaluated     individually, and the two groups will be compared.   "
2606|NCT03251794|"     Preterm birth continues to be a major public health problem with lasting family and societal     repercussions. Despite tremendous research effort, prevention strategies have failed, and the     prevalence of preterm birth in the United States reached 12.3% in 2003.      Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks'     gestation. The rate of prematurity increases dramatically with the number of fetuses -     singletons 10%; twins 54.9%; and triplets 93.6%   "
2607|NCT03251781|"     Background: The ability to perform activities of daily living (ADL) in patients with chronic     obstructive pulmonary disease is often impaired. Glittre-ADL Test has been used to assess     limitations in ADL, and it seems to be responsive to intervention. However, the minimal     detectable change for Glittre-ADL Test remains unknown. Design: Non-controlled before and     after study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation     program in Florianopolis, Brazil. Subjects: Patients with COPD (GOLD II-IV). Interventions:     Pulmonary rehabilitation program based on physical training, conducted over 24 sessions     supervised, three times a week, including aerobic training in treadmill and localized     training for upper limbs and lower limbs. Main measures: Glittre ADL-Test performance,     six-minute walk test performance, London Chest Activity of Daily Living score, Modified     Medical Research Council score, COPD Assessment Test score, Saint George Respiratory     Questionnaire score before and after the pulmonary rehabilitation program.   "
2608|NCT03251768|"     Evaluation of the efficacy and safety of recombinant human serum albumin /     granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced     neutropenia   "
2609|NCT03251755|"     According to the data from WHO, currently there are 350 million people with diabetes mellitus     in the world, and the amount of which is still increasing. Among all types of diabetes     mellitus, people with type 2 diabetes mellitus are at most, and the proportion of which in     Taiwan is 98%. One third of the group suffers from sleep disorder. The prevalence rate is     33.7-52%, similar with the abroad prevalence rate (38.4%), but it's much higher than the     prevalence rate of the general public(20.8%). As a result, people with diabetes mellitus are     at high risk of sleep disorder. Not having enough sleep or sleep badly tend to cause abnormal     metabolism, which influence the control of glycemia and worsen the disease. Currently     investigations emphasize prevalence rate, risk factors and diabetes mellitus, increasing     glycemia, complications which result from lack of sleep. Primary improving methods include     the improvement of sleeping environment, recommendation of healthy diet, exercise and getting     oriental medicine treatment. At the present time, WHO is actively promoting the combination     of oriental treatment. Consequently, expecting the intervention of Dao-in(Chinese Yoga) could     help to improve sleep quality, HbA1c rate and oriental medicine constitution, in order to     decrease the incidence of complications and improve the quality of life, which could also     decrease the expense of medication and act as a health care for diabetes mellitus patients.   "
44453|NCT02703844|"     The purpose of this study is to determine whether caloric vestibular stimulation improves     symptoms of Parkinson's Disease.   "
2610|NCT03251742|"     The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers     (ventricles) to allow blood flow within two distinct circuits: pulmonary and systemic.     The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic     circuit delivers oxygen-rich blood throughout the body. In children born with a single     ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen     levels in the blood delivered to the body (cyanosis).      The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to     deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made     connection (whereby two large body veins [cavae] are sewn to the pulmonary arteries), thereby     preventing mixing of blood through restoration of two distinct circuits without mixing of     blood. Although the Fontan operation effectively eliminates cyanosis and enables survival     into adulthood, increased systemic venous pressure is an unavoidable systemic complication     and low cardiac output (CO) is pervasive finding.      Despite excellent pediatric surgical results, the risk of late complications and death     dramatically increases in the decades following Fontan surgery. A chronically low CO state     secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction     and shortened life expectancy. Short of heart transplantation, deemed suitable only for a     minority of patients, effective therapies for low CO are largely absent. The investigators     aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO.     Specifically, external suction is applied intermittently to the chest wall, much like a     vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass®     ventilator (Hayek Medical). Although used in patients with lung disease, the investigators'     proposal is to evaluate this novel, portable, ventilation system would be the first study of     its kind in adults with congenital heart disease, specifically those with a Fontan     palliation.   "
2611|NCT03251729|"     The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of     spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length     (<=25mm) and without prior spontaneous preterm birth   "
2612|NCT03251716|"     In early clinical study investigators confirmed that berberine could prevent glucose and     lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and     safety of berberine in treatment for metabolic syndrome in schizophrenia.   "
13687|NCT03106285|"     This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938     supplementation on infantile colic in Indonesian infants.   "
2614|NCT03251690|"     According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended     first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an     alternative one. Most of the randomized-controlled studies, including ECHO and THRIVE, showed     the non-inferiority of RPV compared with EFV in naive cases. But there were not much     randomized-controlled trials for changing from other NRTI to RPV in patients who currently on     another ART, especially in Thailand. Moreover, the concerned adverse effects of dyslipidemia     and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the     cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of     economics.   "
2615|NCT03251677|"     The objective of this study is to compare the perioperative outcomes between mini-lap     hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.   "
2616|NCT03251664|"     This study investigates the association between locally consumed food items with anemia among     pregnant women, in Addis Ababa city, Ethiopia.   "
2617|NCT03251651|"     Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been     reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive,     and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the     abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or     aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is     important to promptly manage such behaviors associated with hyperactive delirium.     Intraoperative sedation plays an important role in relieving anxiety or stress response of     patients. Propofol—a common sedative agent—was reported to cause delirium more frequently,     compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated     patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid     consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU     sedation or procedural sedation. However, there has not been any prospective randomized study     investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects     postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study,     based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence     of abnormal psycho-motor behavior compared with propofol sedation, investigators     prospectively will investigate the incidence of postoperative delirium in elderly patients     who undergo orthopedic surgery with regional anesthesia.   "
2618|NCT03251638|"     Hearing loss is one of the most common congenital anomalies. Early Intervention at or before     6 months of age allows a child with impaired hearing to develop normal speech and     language.Auditory brainstem response , otoacoustic emissions testing have all been used in     newborn hearing-screening programs   "
2619|NCT03251625|"     1. To assess the effect of multistrain probiotics on abdominal pain using a validated          symptom severity score in IBS patients.        2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for          IBS in a tertiary referral centre   "
2620|NCT03251612|"     The purpose of the present study is to investigate the benefit of anti-cancer therapy     administered on the basis of drug sensitivity testing. This concerns colorectal cancer     patients who have previously received standard treatment.   "
2621|NCT03251599|"     Glyceryl trinitrate is used in coronary artery bypass grafting surgery. This surgery     frequently employs hypothermic cardiopulmonary bypass, where the whole body is cooled down to     28-32 °C to arrest the heart, and protect the organs from ischemic insult. When the cardiac     repair or grafting is done, the body is warmed to 37 °C. During this rewarming period, the     heart has to beat against the vessels, all of which are constricted due to hypothermia.      To overcome this constriction of the vessels, and decrease the workload of the heart,     glyceryl trinitrate is infused. This drug causes significant dilatation in arteries and     veins, which allows the heart to pump the blood with less force. The dilatation of the     vessels also allows the body to rewarm more easily.      The investigators' concern is whether increased infusion rates of glyceryl trinitrate may     cause uncontrolled rewarming of the brain or not. The investigators will measure the     temperature of the brain using a temperature probe located in the nasal cavity. The     temperature will be recorded at each minute during the the rewarming period. Results of two     commonly used infusion rates of glyceryl trinitrate will be compared.   "
3120|NCT03245086|"     This study will compare Ferguson hemorrhoidectomy and THD in terms of one-year recurrence in     a large population (N=492). Recurrence is defined as prolapsing internal hemorrhoids at     physical examination performed by a colorectal surgeon.   "
2623|NCT03251573|"     This study is going to apply neuropsychological battery tests to measure cognitive function     across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and     evaluate:        1. The presence and patterns of cognitive impairment in domains of executive function,          perceptual-motor function, language, learning and memory, and complex attention;        2. Clinical characteristics of participants with and without cognitive impairment;        3. the risk factors which might be related to cognitive impairment in this group of          population;        4. The association between cognitive impairment and all-cause mortality, stroke and          non-fatal cardiovascular events;      We hypothesize that hemodialysis patient is going to have cognitive impairment which might be     associated with some risk factors. We also anticipate that cognitive impairment might have     some kind of association with the clinical outcomes like all-cause mortality, stroke and     other common clinical outcomes that we mentioned above.   "
2624|NCT03251560|"     A prospective random control clinical trials to research Fuke Qianjin capsule's effects on     ameliorating the pain caused by chronic pelvic disease.   "
2625|NCT03251547|"     This is a retrospective descriptive study, to study the treatment indications, changes in     transfusion need, coagulation profiles changes and clinical outcome (survival, complication)     of non-haemophiliac patients who received activated factor seven (rFVIIa / NovoSeven®) during     massive bleeding in Hospital Universiti Sains Malaysia (HUSM)   "
13688|NCT03106272|"     To describe AMH serum levels dynamics during natural cycle using an automated assay.   "
2630|NCT03251482|"     The primary purpose of Part 1 in this study is to assess the safety and tolerability of     JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite     of major, clinically relevant non-major, and minimal bleeding events) for the selection of     doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of     JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal     deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated     leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).   "
2631|NCT03251469|"     The aim of this study is to investigate the hypothesis that single dose of tranexamic acid     (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip     fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing     and cemented hemiarthroplasty respectively. After application of inclusion and exclusion     criteria, patients will be randomized in two groups. Group 1 will include patients that     receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that     receive normal saline (control group).   "
2632|NCT03251456|"     Visual development disorders are major public health problems among children especially in     China. How to find an effective and economic way to manage the larger number of children in     China remains exploring. The national basic public health services of China offer visual     acuity screening for preschool children for free every year. The aim of this study is to     demonstrate the feasibility, cost-effective and the influence factors of compliance of     tertiary care for visual developmental disorders in pre-school children after screening, and     whether this disease management model is more effective and superior than the current medical     care in china.   "
2633|NCT03251443|"     The purpose of this study is to explore the efficacy and safety of second-line treatment of     apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety,     progression free and overall survival. The primary endpoint of this study is objective     response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).   "
2634|NCT03251430|"     Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the     deterioration of bone architecture, is a serious complication in the long course after     gastrectomy. The aim of the present study was to evaluate osteoporosis by using     high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course     after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years     should have elapsed since gastrectomy.   "
2635|NCT03251417|"     Esophageal cancer is a common malignant disease worldwide especially in china. Though     esophagectomy and definitive chemoradiotherapy are standard treatments, disease relapses in     many patients and the prognosis of metastatic ESCC is still poor. For patients with     unresectable or metastatic ESCC, chemotherapy is an important treatment alone or with     radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and     is used as first-line treatment of ESCC. As for 2nd-line treatment, both irinotecan and     taxane had been recommended based on data from clinical trials which were most enrolled     esophageal or esophageal-gastric junction adenocarcinoma and with only small sample size.     Therefore, it is still urgently needed to explore effective 2nd-line treatment for ESCC.      Apatinib, also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical     data had shown that it is effective in the treatment of a variety of solid tumors including     esophageal cancer. It had been approved as a 3rd-line treatment for patients with advanced     gastric cancer by state FDA of China in 2014. And the safety data showed that hemorrhage is     rare and non-fetal which is different from bevacizumab.      Therefore, the investigators initialize this phase II study to explore the efficacy and     safety of irinotecan and apatinib combination treatment in unresectable or metastatic ESCC     patients who failed in 1st-line chemotherapy or chemoradiotherapy.   "
2636|NCT03251404|"     This study evaluates the effects of two different injury prevention exercise programs on     sports-relevant performance tests and neuromuscular function in youth football players. Half     of participants will receive education on an existing and previously tested exercise program,     while the other half will receive education on a newly developed exercise program.   "
2637|NCT03251391|"     The main purpose of this study is to see if it is safe and feasible to use cardiac     rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful     revascularization. This study will also test if CR improves quality of life and health     outcomes in PAD patients.   "
2638|NCT03251378|"     The study is an open-label, dose escalation clinical trial to evaluate the safety,     tolerability, and PK of fruquintinib in patients with advanced solid tumors. Study will be     conducted in up to 5 sites in the US.   "
3813|NCT03235986|"     The present study will mainly aim at investigating the safety, tolerability and efficacy of     different escalating single doses administration of nebulised Curosurf®, in preterm neonates     with RDS (Respiratory Distress Syndrome) during nCPAP.   "
2639|NCT03251365|"     A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the     incorporation of other centers that would increase the power of the obtained results . Our     hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with     gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer     by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells,     improving the survival of patients with pancreatic cancer, and decreasing the recurrence of     the disease   "
2640|NCT03251352|"     The primary objective of this study is to describe the maintenance of the molecular remission     after tyrosine kinase inhibitor (TKI) disconnection in chronic myeloid leukaemia (CML)     patients in China in the real-world clinical practice setting. This is a post-marketing,     non-interventional, single-arm, prospective registry study in adult patients with chronic     phase (CP) and accelerated phase (AP) in China. Patients will be recruited consecutively from     the study sites during the enrollment period. The enrolled patients will be undertaking TKI     discontinuation under the conditions of informed consent and frequent monitoring according to     the clinical guideline.   "
2641|NCT03251339|"     Thie primary purpose of this study is to compare the immunogenicity and safety of MSB11455     and Neulasta in healthy adult subjects.   "
2642|NCT03251326|"     Despite the prevalence of cannabis use among the PTSD population and self-reports that it is     used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are     unknown. The purpose of this placebo-controlled, within-subject study is to assess the     effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the     primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in     cannabis smokers with PTSD.   "
2643|NCT03251313|"     This is a Phase I dose escalation trial to assess dose-limiting toxicity (DLT) and MTD of     JS001+GP in advanced/metastatic TNBC patients, and to determine the recommended Phase II dose     and the best combination regimen.   "
2644|NCT03251300|"     The aim of this study is to elucidate whether night-time dosing of mirebegron can improve     nocturia, compared with daytime dosing of mirabegron.   "
2645|NCT03251287|"     Inorganic nitrate, which is found at high levels in green leafy vegetables, is reduced to     nitrite by bacteria in the mouth, swallowed, and absorbed in the stomach into the blood.     Studies have shown that increasing the blood levels of nitrite improves the way that muscles     use oxygen and energy during exercise, and potentially blood flow.      Some people (~1 in 500) suffer from a type of genetic heart condition known as hypertrophic     cardiomyopathy (HCM). This condition means that the muscle in the heart does not use energy     well and becomes larger than average, meaning that they have to tap into the heart's 'energy     reserves'. It is not known if nitrite has the same beneficial effects on heart muscle as on     other muscles in the body. Our study will explore the mechanism by which nitrite may improve     the function and energy status of the heart in HCM.   "
2646|NCT03251274|"     The study is divided into two stages, the purposes of the first stage are (1) to examine the     feasibility and simplicity of the operation of bathtub machine for nurse aides; (2) to     examine the safety and comfortability of the bathtub machine from the perspectives of the     nurse aides. The purposes of the second stage are (1) to understand the experiences of nurse     aides and the elderly with disability by using the bathtub machine(which has edde massage     function); (2) to evaluate the effectiveness of using the bathtub machine on the sleep     quality and body temperature in the elderly with disability.   "
2647|NCT03251261|"     To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of     age) saliva swabs   "
2648|NCT03251248|"     The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of     MSB11455 and Neulasta in healthy adult subjects.   "
2649|NCT03251235|"     Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective     intervention, but the brain mechanisms driving recovery are largely unknown. In this     experimental medicine study, it will be investigated to what degree CBT affects neural     markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes     which might be crucial in the process of recovery as opposed to those seen following full     treatment completion. Patients with panic disorder will be recruited and randomly allocated     to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group     not receiving any interventions until after the experimental procedure.   "
2650|NCT03251222|"     For patients with eye surgery and shorter surgery, sedation is a well-established method in     preserved consciousness and has been successfully used for several years. We have also     developed and published a valid protocol (1).      Remifentanil is used in intravenous infusion for sedation and anxiolysis. Remifentanil is a     descriptive analgesic, which also works partially anxiolytically. In eye surgery, it is     important that the patient cooperates during the operation and should not be ashamed, as     injury to the eye could occur, because the vitrectomes are performed with a fine intraocular     endoscopic technique, in which the operator inserts his instruments through the whiteness     into the eye. For this reason, we have not yet added additional sedatives (for example,     midazolam), which is very unpredictable as regards sedation. Remifentanil is also very     unpredictable and it is very difficult to control it during the operation so that the patient     is saturated with satisfaction.      Lately, dexmedetomidine has been successfully used in sedation for other areas of surgery (eg     neurosurgery, maxillofacial surgery, ORL). It is a safe, proven, active substance with alpha     2 agonistic effect, which has not yet been used in the field of ocular surgery and has not     yet published articles in this field. The substance is very suitable because it works mildly     sedative and at the same time analgesic.   "
2651|NCT03251209|"     Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes     changes that limit the individual in his ability to maintain an active social life. Mental     Practice (MP) consists of the internal reproduction of an event, which is repeated     extensively in order to learn or improve an already known skill. The objective of the study     is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects     with unilateral stroke over 6 months, age> 18 years and who were able to hold objects will be     selected. Subjects with painful conditions that affected exercise performance,> 3 spasticity     by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be     excluded.   "
45171|NCT02694445|"     The purpose of the study is to estimate the Chinese economic burden in patients with     Alzheimer's Disease (AD).   "
2652|NCT03251196|"     This is an observational cohort study. Pulmonary tuberculosis (TB) patients will be enrolled     at the time of TB diagnosis and prospectively followed for at least two years after     TB-treatment initiation with optional prolonged follow-up. Study visits will be performed in     the study clinics or if necessary at the participant's home at pre-defined time points after     TB treatment initiation. Clinical assessments, biological sample collections and collection     of socio-economic data will be performed according to the pre-defined schedule of events.   "
2662|NCT03251053|"     The purpose of the study conducted at VA Medical Center in Miami is to determine if smoking     electronic cigarettes (known as e-cigarettes) that contain nicotine have less negative     effects than regular cigarettes on the person's respiratory health. We will assess this by     measuring pulmonary function tests, several body molecules and functionality of the airway     cells. We will also evaluate how smokers can maintain exclusive electronic cigarettes use.      In this study, some people will continue to smoke regular tobacco cigarettes while others     will switch to a nicotine-containing electronic cigarette.   "
2663|NCT03251040|"     Anastomotic leakage remains a major complication after esophageal surgery. Amongst other     preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic     techniques. The investigators aimed to investigate feasibility of additional sealing by means     of autologous fibrin sealant of the esophageal anastomosis.   "
2653|NCT03251183|"     Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people     >75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved     (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year     and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical     cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no     non-invasive measure provides a clear diagnosis.      Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation     of heart structure and function. New CMR parameters offer the possibility to describe the     underlying pathological and physiological changes associated with HFpEF.      The investigators propose to undertake the first systematic comparison between a CMR protocol     and invasive haemodynamics as the best possible gold standard, as well as define the     histopathological drivers in myocardial biopsies. The investigators will also examine the     relations with tissue and serological biomarkers implicated in HFpEF and the role with     standard and novel parameters by echocardiography. If successful, this study will provide     tools for a reliable and accurate non-invasive characterization of patients with HFpEF,     supporting the diagnosis and grading the severity of disease. This study will provide a     reference basis for future diagnostic algorithms in HFpEF, both, for CMR and     echocardiography, but also for their relative value in comparison to blood markers or     invasive testing. In addition to a new pathway to acess the effects of current and novel     therapeutic interventions, the investigators see the greatest potential in identifying a     disease stage where the myocardial injury may be reversible.   "
2654|NCT03251170|"     The aim of this work is to compare two protocols (ketamine-midazolam versus     fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find     the most safe protocol with regards to hemodynamic status of patients   "
2655|NCT03251157|"     The Nutrition Study of the GA2LEN Follow-Survey was designed to investigate the association     between usual dietary intake and allergic and respiratory outcomes in adults across Europe.     Within this framework, a food frequency questionnaire (FFQ) was designed to ascertain usual     dietary intake of 250 food items, which was translated into the languages of the participant     centres. Information on daily intake of foods, nutrients, and flavonoids was derived.   "
2656|NCT03251144|"     Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV     infection but the mechanisms are unclear. Understanding how antiretrovirals can minimize     morbidity in treated HIV infection is a research priority. Nucleoside/nucleotide reverse     transcriptase inhibitors (NRTIs) are included in all HIV treatment regimens. Tenofovir (TFV)     disoproxil fumarate (TDF) has been associated with an increased risk of nephrotoxicity and     bone disease compared with other NRTIs. Tenofovir alafenamide (TAF) is an oral prodrug of     TFV, but is more stable in plasma as compared with TDF and lower plasma levels of TFV are     thought to lead to the favorable safety profile of TAF. Mitochondrial dysfunction has a key     role in HIV pathogenesis and may be the common denominator that drives pathogenesis of     several comorbidities. Despite the better safety profile of newer (such as TDF) compared to     older NRTIs, there are concerns for the potential for longer term toxicity of NRTIs since the     exact cellular effects of NRTIs remain unclear. It is unknown whether a four-fold increase in     intracellular drug levels seen in peripheral blood mononuclear cells (PBMCs) with TAF may     increase toxicity in mitochondria. Better understanding of these effects could provide     insights into mechanisms of HIV pathogenesis and selection of NRTIs that improve morbidity in     chronic HIV infection.      Hypothesis: Despite higher intracellular levels, TAF has minimal mitochondrial toxicity     compared to TDF in vivo. This research will explore the relative mitochondrial toxicity of     newer NRTIs (TAF, TDF) as a possible mechanism for differential NTRI-related toxicities.     These data will allow selection of NRTIs that may improve morbidity in chronic treated HIV     infection. Towards this aim, the investigators will use a robust experimental approach to     study NRTI-related mitochondrial dysfunction using novel methods, human cell lines and PBMC.     Our specific aims are: Aim 1: To evaluate the relative in vitro effects of TAF and TDF     compared to an older NRTI (ddC) on 5 independent measures of mitochondrial function in the     human cell line HepG2 and PBMC. Aim 2: To explore in vivo whether there is increased     mitochondrial dysfunction with the use of TAF vs. TDF in chronic treated HIV infection. The     investigators anticipate that the proposed experimental approach will set the basis for     future large scale studies to directly compare subtle potential mitochondrial toxicities of     newer NRTIs in large HIV cohorts.   "
2657|NCT03251131|"     Observational studies among patients with acute kidney injury (AKI) have shown an association     with fluid accumulation and increased mortality. Trials among other subgroups of critically     ill patients have demonstrated that restricting fluid input after the initial resuscitation     appears safe.      The objective if this study is to determine whether a fluid restrictive treatment regimen     will lead to a lower cumulative fluid balance at 72 hours from randomization in critically     ill patients with AKI and whether this approach is safe and feasible.   "
2658|NCT03251118|"     TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients     (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical     practice. TARGET-IBD will create a research registry of patients with IBD within academic and     community real-world practices in order to assess the safety and effectiveness of current and     future therapies.   "
2659|NCT03251105|"     In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their     performance characteristics, including insertion features, ventilation parameters, induced     changes in hemodynamics and rates of postoperative complications.   "
2678|NCT03250845|"     The purpose of this observational study is to compare the administration of standard of care     Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion     time and infusion related reactions. Patient satisfaction, number of actions taken by the     nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.   "
2660|NCT03251092|"     This trial will enroll healthy volunteers into a single ascending dose (SAD), multiple     ascending dose (MAD), and Food Effect (FE) treatment groups.      The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy     adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and     will be followed for 7 days post dose. A safety review committee (SRC) will convene after the     completion of each cohort to evaluate safety and pharmacokinetic (PK) data.      Following the conclusion of the respective SAD level dose groups and after sufficient review     of study data and approval by the SRC, a second set of healthy adult subjects will     participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3     ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or     placebo daily for 7 days and will be followed for 7 days after receiving the last dose.      Also following the conclusion of the respective SAD level dose groups and after sufficient     review of study data and approval by the SRC, 12 healthy adult subjects will participate in     the FE treatment group.   "
2661|NCT03251066|"     Investigation of the immediate effect on subjective relief of symptoms by Proponent - Nasal -     Spray after a one time administration (following a single dose administration in each     nostril) in an open, not randomised, non-blinded single centre observation study on 40     volunteers between 18-75 years of age with an unspecific discomfort in the nose such as     enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or     feeling of a dry nose.   "
4398|NCT03228277|"     The purpose of this study is to evaluate the efficacy of Olmutinib(Olita®) in patients with     T790M-positive non-small cell lung cancer (NSCLC) confirmed using DNA extracted from     extracellular vesicles of bronchoalveolar lavage fluid.   "
2664|NCT03251027|"     This phase II trial studies how well intensity-modulated stereotactic radiation therapy works     in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized     radiation therapy that delivers a single, high dose of radiation directly to the tumor and     may cause less damage to normal tissue.   "
2665|NCT03251014|"     The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy     overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic     effects and the effects may be similar with salmon.   "
2666|NCT03251001|"     The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and     histological results of acellular dermal matrix allograft (ADM) compared to autogenous free     gingival graft (FGG)   "
2667|NCT03250988|"     The purpose of this study is to improve spasticity diagnosis through exploration of potential     new diagnostic markers for spasticity that can assist in diagnosis and referral.   "
2668|NCT03250975|"     The purpose of this investigation is to delineate the incidence of acute and chronic     laryngeal injury following intubation within our health system. In addition, this study seeks     to identify risk factors for airway injury that may provide information to help reduce the     incidence of injury or increase the speed of diagnosis through hospital based process     measures.      Study Aims        1. Determine the incidence of acute laryngeal injury in patients with prolonged intubation.        2. Determine the incidence of chronic laryngeal injury in the subset of patients with acute          laryngeal injury   "
2669|NCT03250962|"     The purpose of this study is to evaluate whether treatment with the study drug decitabine in     combination with SHR-1210 is safe and feasible, is more effective than treatment with     SHR-1210 alone,and reverse the resistance of Anti-PD-1 antibody in patients with HL.   "
2670|NCT03250949|"     Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following     Over-drilling Compared To Conventional-Drilling Protocol   "
2671|NCT03250936|"     The aim of this study is to compare trauma related to others sport to trauma due to     trampoline in pediatric emergencies of Rennes.   "
2672|NCT03250923|"     CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is being evaluated for     safety and effectiveness as a potential treatment for candidiasis, a yeast infection,     commonly known as thrush, which is associated with mouth sores. CelAgace™ contains two active     ingredients, a silver citrate complex salt that has demonstrated laboratory effectiveness     against yeast organisms and acemannan, a purified extract isolated from the inner leaf gel of     the Aloe vera plant that has been used as a key ingredient in other oral care products.     Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14     days. Following an initial office visit, patients will be evaluated on days 7 and 14 to     determine response to the product.   "
2673|NCT03250910|"     Data are limited regarding the effectiveness and safety of generic velpatasvir plus     sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus     (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the     effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected     and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are     compare between the two groups. The characteristics potentially related to sustained     virologic response 12 weeks off therapy (SVR12) are analyzed.   "
2674|NCT03250897|"     The aim of the study is to investigate by flow cytometry the phenotype of alveolar     macrophages (AMs) isolated from patients with non-infectious lung diseases.   "
2675|NCT03250884|"     The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to     improve the medical care of patients in emergency room.   "
2676|NCT03250871|"     Hypnosis has already shown an improvement in the support of patients in several surgical     areas but has never been studied in cardiology. This research is a study non interventional,     prospective, monocentric, controlled and randomized.      Patients over 18 years old and hospitalized for implantation of a pacemaker or ablation of     atrial flutter may be included and randomized into one of the arms: placebo or hypnosis.      The pain will be assessed by a visual analogue scale and the anxiety by a self-administered     questionnaire.      The aim is to improve the support of patients and reduce analgesic consumption.   "
2677|NCT03250858|"     The EatWellUK study aims to investigate the effectiveness of a mobile web application     (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet     quality.      Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has     been designed for better usability) and dietary feedback is derived according to adherence to     an 11-item modified US Alternative Healthy Eating Index (m-AHEI).   "
2679|NCT03250832|"     This is a multicenter, open-label, first-in-human Phase 1 study evaluating TSR-033, an     anti-LAG-3 Monoclonal Antibody, alone and in combination with an anti-PD-1 in Patients with     Advanced Solid Tumors in a broad range of solid tumors. Patients with disease types selected     for evaluation in this study are expected to derive clinical benefit with addition of an     anti-PD-1. The study will be conducted in two parts: dose escalation and cohort expansion.   "
2697|NCT03250598|"     The purpose of this Phase I, single-dose, open-label trial is to evaluate the     pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and     Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in     Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at     specified times during conduct of the study.   "
2698|NCT03250585|"     Secretory phosholipases A2 (sPLA2) are significantly elevated in the plasma of sickle cell     disease patients with acute chest syndrome, and similar enzymes have been measured in exhaled     breath condensate (EBC), which is collected easily and non-invasively. The investigators     hypothesize that sPLA2 will be measurable in EBC samples from sickle cell patients with acute     chest syndrome   "
5672|NCT03211650|"     The purpose of this study is to evaluate the efficacy of intra-articular injections of     combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in     improving joint function and reducing pain.   "
2681|NCT03250806|"     Prospective cohort study to test the hypothesis that patients identified with severe aortic     stenosis are under-diagnosed and under-treated. Such patients shall be identified by     auscultation or target echocardiography during flu vaccination. The hypothesis is that this     will increase detection of aortic stenosis in the community.   "
2682|NCT03250793|"     Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with     significant mortality and respiratory morbidity, particularly related to prolonged mechanical     ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the     recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a     synchronized proportional assisted ventilation. This technique has already been used in the     newborn, especially premature and has shown many benefits. Only one study in the literature     shows its feasibility in newborns with CDH. This technique seems interesting in the context     of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating     the clinical benefits, it seems important to describe the effects on the respiratory     physiology, in particular on work of breathing which can be estimated by the esophageal and     trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is     an innovative physiologic pilot study with the objective to describe work of breathing in     neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation     using an esophageal transducer. It will provide the clinician with a physiological     justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of     these patients. This study is a prerequisite for the realization of studies demonstrating the     clinical benefit of NAVA ventilation on reduction of duration of ventilation and more     generally on morbidity and mortality in the population of neonate with CDH.   "
2683|NCT03250780|"     Patients with longstanding ulcerative colitis (inflammatory bowel disease, IBD) have     increased risk of developing colorectal cancer (CRC) when compared with that of the general     population. Therefore patients with longstanding colitis undergo regular screening     colonoscopy at varied time intervals depending on their individual risk. This is thought to     detect early mucosal (interior bowel lining) abnormalities, known as dysplasia, which can     progress to CRC. Until recently, IBD surveillance has relied upon colonoscopy with multiple     (at least 33) random biopsies of the bowel lining to detect dysplasia, but now international     guidelines recommended a technique called chromoendoscopy.      Chromoendoscopy involves applying a dye, called indigo-carmine, to the bowel lining whilst     performing colonoscopy which highlights more subtle abnormalities, therefore increasing     dysplasia detection rate.      There is no standard international concentration of the dye spray used during     chromoendoscopy. Studies have used different concentrations of indigo-carmine dye ranging     from 0.1 to 0.4%. We have recently shown that 0.2% dye improves detection rates compared to     high definition white light. The recent international SCENIC guidelines suggest using 0.03%     indigo-carmine via a foot pump. However there are no trials comparing the two methods and no     previous trials have used the 0.03%. We therefore aim to perform a randomised control trial,     comparing 0.03% indigo-carmine dye versus 0.2% in detecting dysplasia in patients undergoing     surveillance colonoscopy in IBD. Any lesions seen will assessed using standard endoscopic     appearance but also using optical biopsy forceps to further characterise the lesion, then     manage the lesion as standard guidelines. We will also take two additional rectal biopsies,     which will be snap frozen in liquid nitrogen and then studied using Raman Spectroscopy, Infra     Red spectroscopy and electrochemical impedance to develop optical markers to identify     patients at higher risk of dysplasia.   "
2684|NCT03250767|"     A post market, prospective, non-randomized, multi-center, open-label, clinical study using     survivorship as the reference performance goal to study the safety and efficacy of the Titan     Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.   "
2685|NCT03250754|"     Headache disorders (HDs), which are characterized by recurrent headache, constitute a     public-health problem of enormous proportions, with an impact on both the individual sufferer     and society. The stated goals of long-term headache treatment are to reduce the frequency,     severity, and disability associated with acute attacks; decrease the reliance on poorly     tolerated, ineffective, or unwanted acute pharmacotherapies; and avoid acute headache     medication escalation. There is risk for adverse events, leading some patients to refuse     prophylactic therapy. Acupuncture is widely used for the treatment of headaches and it may be     applied as a single modality as well as part of a more complex treatment program. The     objective of this study will be to investigate whether acupuncture in routine clinical     practice ((Real World Data) is more effective than treatment of acute migraine attacks or     routine care only in reducing headache frequency.   "
2687|NCT03250728|"     The aim of the study is to evaluate the role of the endothelial barrier in the occurrence of     stroke-like episode. And to study the protein C system on the surface of the endothelium.   "
2699|NCT03250572|"     This study was designed to assess the relation between serum ferritin and hepatic fibrosis in     patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in     addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its     correlation with steatosis and fibrosis was done.   "
2769|NCT03249662|"     To study efficacy of postoperative pain control of different concentrations of bupivacaine     for periarticular infiltration, part of multimodal analgesia, in bilateral total knee     arthroplasty.      To study plasma concentration of bupivacaine in patient who received spinal anesthesia and     single shot bilateral adductor canal block and periarticular infiltration with bupivacaine     for safety level.   "
2688|NCT03250715|"     This study aims to verify the effects of low level laser therapy (LLLT) on functional     capacity, DNA damage, lower limbs muscle strength, quadriceps muscle architecture, muscle     pain and perception of lower limb fatigue, inflammatory profile, oxidative stress and quality     of life of patients with chronic kidney failure on hemodialysis. Patients will be randomized     into two groups: the control group and the LLLT group. The control group will only be     evaluated and reassessed. The LLLT group in addition to the evaluations will receive LLLT     three times a week for eight weeks during HD. The evaluations will be performed     pre-intervention, after 4 and 8 weeks of therapy. However, the muscle architecture evaluation     will be performed only at pre intervention and after 8 weeks.      The evaluations carried out are: six-minute walk test for functional capacity; alkaline comet     assay for DNA damage; sit-and-lift test, and load cell dynamometry for evaluation of lower     limbs muscle strength; quadriceps ultrasonography for muscle architecture and echogenicity;     visual analogue scale for pain; subjective perception of effort by Borg scale for fatigue;     measurement of interleukins 6 and 10, tumor necrosis factor, reative C protein and muscle     damage markers (lactate, creatine kinase) for the inflammatory profile; protein     carbonylation, superoxide dismutase, catalase, total sulfuric acid and dichlorofluorescein     diacetate for oxidative stress and application of the Kidney Disease and     Quality-of-Life-Short-Form and EQ-5D questionnaires for quality of life.   "
2689|NCT03250702|"     The aim of the Dar es Salaam Urban Cohort Hypertension Study (DUCS-HTN) was to determine the     current prevalence, risk factors, and barriers to diagnosis and treatment for hypertension in     Dar es Salaam, Tanzania. Few previous studies in Tanzania have analyzed the modifiable     determinants of high BP as well as barriers to diagnosis and treatment of hypertension.      DUCS-HTN is a cohort of adults living in the Ukonga ward of Dar es Salaam who had been     registered in the Dar es Salaam Health and Demographic Surveillance System (HDSS) in 2011.     Due to the large size of Ukonga, the investigators chose to randomly sample two of the seven     neighborhoods that compose Ukonga and then conducted a census of these two randomly selected     neighborhoods, Mwembe Madafu and Markazi. The investigators attempted to contact all 4896     HDSS participants who were at least 40 years of age and lived in one of these neighborhoods.      Trained interviewers conducted face-to-face interviews and physical examinations in     participants' homes from March to June 2014. Follow-up visits were conducted from April to     June 2015.      Among 4896 potentially eligible participants from the HDSS baseline survey, 3604 (74%) were     still living at the same address in 2014. Of these, 2290 (64%) enrolled in the DUCS-HTN     study. Of the participants enrolled at baseline, 1752 (77%) participated in the follow-up     study.      Blood pressure measurements      Trained interviewers measured blood pressure with digital blood pressure monitors (15 Omron     M2 and 5 Beurer BM 40 monitors). Standard, large, and extra-large cuff sizes were used     according to the size of a participant's arm. Blood pressure was measured three times with at     least a 5-minute rest before the first measurement and 3-minute rests between each subsequent     measurement. Blood pressure was taken on the left arm with the participant seated and the arm     straight at heart level. Usual blood pressure values were calculated as the mean of the     second and third readings. If a second visit was conducted, usual blood pressure values were     defined as the mean of the second and third readings at both the first and second visits.      Hypertension was defined as SBP≥140 mmHg or DBP≥90 mmHg, or self-reported use of     anti-hypertensive medication. Grade I hypertension was defined as SBP of 140 to 159 or DBP of     90 to 99 mmHg; grade II hypertension was defined as SBP of 160 to 179 or DBP of 100 to 109     mmHg; and grade III hypertension was defined as SBP≥180 or DBP≥110 mmHg. Hypertension control     was defined as current antihypertensive use and blood pressure of less than 140/90 mmHg. If a     participant was found to have grade I or II hypertension, a second visit was scheduled, at     least three days later. Those with grade III hypertension at the last reading of the first     visit or grade I or II hypertension at the last reading of the second visit were told that     they had high blood pressure, advised to see a health professional and were given a referral     letter. In addition, a second visit and blood pressure reading was scheduled for a random     sample of one-fifth of participants, who were selected for additional blood, urinary, and     dietary measurements.      Assessment of covariates      All participants were administered a socio-demographic and lifestyle questionnaire and had     their height, weight, and waist and hip circumference measured. Some demographic information     (age, sex, neighborhood, religion, and assets used to create a household wealth index) was     previously recorded during the HDSS baseline. Information on household health insurance     coverage was collected in 2015 as part of routine HDSS updates.      Standard protocols were used to take anthropometric measurements. Participants were weighed     with minimal clothing using a digital scale (Seca, Germany) to the nearest 0.1kg and height     was measured, with participants not wearing shoes, to the nearest 1cm. Body mass index (BMI)     was calculated as the ratio of weight in kilograms to height in meters squared (kg/m2) and     categorized according to WHO categories.      The Global Physical Activity Questionnaire (GPAQ) was used to assess physical activity for     work, transportation, and leisure. The investigators defined physical inactivity according to     WHO guidelines. Number of servings of alcoholic beverages consumed was reported over the past     30 days. The investigators assumed 14 grams of alcohol as a standard drink portion size. A     household wealth index was created through a principal component analysis of household     characteristics and assets, and was categorized into quintiles. In the follow-up visit,     participants were asked about their health over the past year and the reasons for not seeking     hypertension care.      A subsample of ~ one fifth of the participants completed a food frequency questionnaire, two     24-hour dietary recalls, a 24-hour urine collection for sodium, creatinine, protein, and     potassium, and had capillary total cholesterol and blood glucose measurements taken.   "
2690|NCT03250689|"     The inflammation associated with COPD is characterized by a prominent infiltration of     neutrophils in lung tissue and airways. The CXC chemokine receptor type 2 (CXCR2) plays a     pivotal role in neutrophil recruitment to the lungs resulting in progressive fibrosis, airway     stenosis, and destruction of the lung parenchyma characteristic of COPD. There is a paucity     of novel therapies that target these symptoms, and there are no currently available therapies     that modify disease progression in COPD. Danirixin (GSK1325756) is a selective CXCR2     antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD     and influenza. This study is a mechanistic study which aims to evaluate the effect of     danirixin in reducing neutrophil extracellular traps (NETs) formation (or NETosis). Subjects     will be randomized (3:1) to receive danirixin hydrobromide (HBr) 35 milligram (mg) orally     twice daily or matching placebo for 14 days. Subjects may continue to use rescue     medication(s) and inhaled COPD maintenance medication(s) during the study. The study will     consist of a screening period of up to 30 days, a 2 week treatment period, and a 1-week     follow-up visit via phone call. Approximately 50 subjects will be screened to obtain     approximately 24 subjects to complete the study.   "
2692|NCT03250663|"     Patients with mild to moderate atopic dermatitis will be asked to participate in helping the     study team determine how well the medication works for atopic dermatitis. They will not be     told that adherence will be monitored. Patients will be dispensed topical crisaborole 2%     ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System     (MEMS) cap if they agree to participate. This cap records dates and times the bottle is     opened and this data can be downloaded and tabulated with the associated software.      Investigators and subjects will be blinded to the adherence data until the final treatment     (12 month) session. The study subjects will be randomized to two groups. After baseline     visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12     months. The intervention group will also be asked to complete an online treatment response     survey designed to improve adherence at weekly intervals for 6 weeks, then monthly     thereafter.      The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to     apply the medication twice daily (morning and evening) to all of their AD lesions. They will     be instructed to apply the smallest amount of study medication possible that is sufficient to     cover all lesions. These instructions are standard-of-care for patients with AD.      Subjects will be asked to bring their medication tubes with them at each visit. At each     visit, the study coordinator will weigh the medication tube and download the MEMS cap data.     Disclosure of the adherence monitoring will occur at the 12 month visit (or end of     treatment), at which time the results of the subject's adherence behavior will be used to     supply individualized treatment options for each subject (feedback session).      At each visit, drug tubes will be measured for weight to determine the amount of study     medication used. This data will be correlated with the extent of BSA involved and the     response of the disease. The MEMS caps will be downloaded at each visit.   "
2693|NCT03250650|"     To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and     percutaneous tibial nerve electrical stimulation (PTNS) in the treatment of female overactive     bladder syndrome (OAB).   "
2694|NCT03250637|"     The aim of this study is to investigate the interaction between diet - primary meat and fiber     - and polymorphisms in Toll-like receptors in relation to risk of colorectal cancer in a     Danish prospective cohort.   "
2695|NCT03250624|"     Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel     group study, involving subjects with chronic lesions of AD to evaluate the local and systemic     safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.   "
2696|NCT03250611|"     The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with     anatomical osseous complex that allows significant mobility while maintaining biomechanical     stability. OC instability is a rare disorder with potentially life-threatening consequences.     Instability may manifest as disabling pain, cranial nerve dysfunction, paralysis, or even     sudden death. The most common acute presentation is secondary to major trauma. Other     pathologic processes that may lead to chronic instability include rheumatoid arthritis,     infections, tumors, and even congenital malformations; OC fusion in aforementioned cases each     according is then indicated.      Stabilization of the OC junction remains a challenge, owing to the regional anatomy and poor     occipital bone purchase. OC stabilization techniques have undergone continuous refinement.     Early techniques involving simple posterior only bone grafts demonstrated a high rate of     failure and have largely been replaced by rigid posterior fixation systems using rods/screws     or plates, providing superior biomechanical stability and higher rates of fusion. One of the     very modern modalities of fixation methods is the Occipital Condyle Screw (OCS) as a sole     cranial anchor; believing that decreasing the length of lever arm of the construct,     increasing the length of the screw purchase, and decreasing stresses addressed on the rod     with no need to excessively bend it for the occipital slope may enhance the construct     rigidity, and leaving a greater clear metal-free area of the occiput for graft contact may     have a real potential benefits in fusion rates.   "
2700|NCT03250559|"     Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal     stones since 1980. Although radiation exposure during PNL is within the safe limits for     expert endourologist, the mutagenic hazard is still present especially in pediatric     population. Therefore, employing an alternative imaging technique during PNL would be of     added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL     with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided     PNL was as effective as conventional one, this means that many children could be protected     from the variable hazards of radiation exposure.   "
2701|NCT03250546|"     The primary objective of this study is to compare the 2-year progression free survival     without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or     severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell     transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched     unrelated donor (MMUD).      It will use a Phase II, multicenter, prospective, randomized clinical trial.      By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test     (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients     need to be recruited in each arm, for a total of 184 patients.   "
2702|NCT03250533|"     One of the important complications of DM is the diabetic foot that may present ulcers, which     result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to     peripheral vascular disease considered the main causes. In this way, the ulcers of the lower     extremities of diabetics, have a complex and long cicatrization process. Faced with this, the     treatment of chronic wounds is challenging, the diversity of treatments is great, however the     search for new modalities of effective therapeutic resources, scientifically proven and     financially feasible, that are available and easily accessible for clinical practice is still     desirable . The aim of this study was to evaluate the responses of phototherapy with light     emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in     ulcers of diabetic patients. Diabetic volunteers who present with chronic skin ulcers will     also be randomized (n = 13) to: Treatment group with LED 620 nm, Treatment group with LED 940     nm, Treatment group with fixed diphasic current and Control group. Interventions will occur     three times a week for 12 weeks and evaluations will occur on the 1st, 30th, 60th, and 90th     day of the intervention, followed by follow-up after 30 days of treatment completion.   "
2703|NCT03250520|"     This Protocol is a pilot, clinical interventional study to selected patients between five and     fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade     recurrent in the central nervous system tumors, in whom there has been no response to     conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow     treatment with conventional measures, and that already have an indication for a neurosurgical     palliative procedure. It will be a close pharmacovigilance on possible adverse effects     related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum     derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will     be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.   "
2704|NCT03250507|"     The goal of this study is to evaluate the effectiveness of different formulations of     bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain     management after open abdominal hysterectomy.   "
2705|NCT03250494|"     75 female patients were randomly allocated into one of three equal groups. Group I(GI)     received Dulox 60 mg orally and 100 ml 0.9% sodium chloride solution (NS) intravenous     infusion (IVI) over 15 min, group II(GII): received combined Dulox capsule 60 mg orally and     Dex 0.1mg/kg mixed with 100 ml NS IVI and group III(GIII) received identical placebo     duloxetine capsule and 100 ml NS IVI as a placebo for Dex, 2 hours preoperatively. Patients`     vitals, VAS and sedation score were assessed at 30 minutes, 1h, 2 h, 6h and 12h     postoperatively. Total pethidine requirements, plasma cortisol, PONV and patient`s     satisfaction were recorded.   "
2706|NCT03250481|"     Systematic evaluation of pain, agitation and delirium in ICU-patients is recommended and deep     sedation should be avoided. Sedation is still monitored with clinical assessments, like RASS.     The Responsiveness Index (RI) is a recently described method for ICU sedation monitoring. It     is based on processed frontal EMG and reflects the interaction between a patient's conscious     state and the intensity and frequency of stimulations during treatment. RI has not been     randomly compared to RASS to titrate sedation to target at a clinically adequate sedation     state. In this open randomized controlled pilot study of 32 critically ill, mechanically     ventilated adult patients, investigators will evaluate the feasibility, safety and efficacy     of RI based sedation compared to standard RASS based titration of sedation. Investigators     hypothesize first that RI controlled sedation will be safe and, second that RI controlled     sedation will associate with increased number of ventilator free days alive in 30 days     without excess adverse events.   "
2707|NCT03250468|"     Research aims:        1. To determine if participation in a group-based cognitive behavioural therapy          intervention (CBT-I) intervention results in improved sleep quality.        2. To determine if participation in a group-based CBT-I intervention results in improved          cardiovascular disease risk factors, and if the CBT-I intervention moderates that          relationship.   "
2708|NCT03250455|"     VALIDITY is a prospective, open-label, multicenter, randomized controlled trial     （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive     anatomic CTA combined with functional CTP for the next clinical decision making and the added     prognostic value of CTP beyond CTA.   "
2709|NCT03250442|"     The purpose of this study is to evaluate how well subjects heal after surgery who receive     standard dressings or incisional negative pressure wound therapy for non-traumatic amputation     sites.   "
2710|NCT03250429|"     To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS)     before and after sinus surgery.   "
2711|NCT03250416|"     The investigator aimed to manage noninvasive ventilation in patients with hypoxemic     respiratory failure.   "
2712|NCT03250403|"     To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP)     injection in the treatment of diabetic peripheral neuropathy compared to traditional medical     treatment.   "
2713|NCT03250390|"     Determination of volatile organic compounds to discriminate patients with lung cancer from     healthy smokers and non-smokers healthy subjects.   "
2715|NCT03250364|"     Despite different types of bandages are using in the lymphedema treatment, numerous of them     have not been directly compared. The aim of this study is to compare the efficacy of five     different kinds of bandages on limb volume and lymphedema-related symptoms. It was also     measured as secondary variables the comfort of the bandage related by the participants and     the directly cost of each kind of bandage during the treatment.   "
3627|NCT03238456|"     The current study aimed to test a culturally tailored program designed to help Pacific     Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized     controlled trial design with one intervention group and one control group.   "
2716|NCT03250351|"     Objective: to determine nerve mobilization techniques effectiveness at improving shoulder     mobility and arm sensitive disorders in the early breast cancer postsurgical period with     axillary lymph node dissection. Design: prospective randomized and single blind trial where     participants will be randomly allocated into two groups by EPIDAT 3.1 software. Follow-up     will be conducted through six physical therapy assessments: one before surgery, the second     one after surgery, the third one post-physical therapy intervention, the fourth one after     three months, the fifth after six months and, the sixth one after twelve months, and the     seven one after 24 months. Participants: one hundred and forty women, who are undergoing a     unilateral breast cancer surgery with axillary lymph node dissection in the Gynaecology and     Obstetrics Unit from Príncipe de Asturias Hospital. Intervention: Early physical therapy to     control group and Early physical therapy plus nerve mobilization to intervention group during     the three following weeks from surgery. Hypothesis: nerve mobilization helps brachial plexus     sliding among its interface which improves sensitive disorders, pain and functionality of the     inner arm. Key outcomes: range of motion, pain, sensitive disorder, functionality, quality of     life.      Data analysis: quantitative variables through t-student test and qualitative variable though     Chi test through by Statistical Package for the Social Sciences software.   "
2717|NCT03250338|"     This is a randomized, multi-center, double-blind, placebo-controlled study designed to     evaluate the efficacy of crenolanib administered following salvage chemotherapy,     consolidation chemotherapy, post bone marrow transplantation and as maintenance in     relapsed/refractory AML subjects with FLT3 activating mutation.   "
2718|NCT03250325|"     The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1     expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.   "
2719|NCT03250312|"     This study intends to understand the effects of osteopathic manipulative treatment (OMT) on     the expression patterns of 60 immune cell biomarkers in the peripheral blood mononuclear     cells (PBMC) of each participant, before and after intervention - OMT or seated control. This     study will utilize participants with a history of low back pain (LBP), and will identify and     validate those immune cell biomarkers that change in most participants after OMT, by using     the novel protein subcellular localization (PSL) microarray technology. This study intends to     uncover the important immune cells affected by OMT techniques, therefore to uncover the     molecular mechanisms of OMT.   "
2720|NCT03250299|"     This phase I trial studies the side effects and best dose of microtubule-targeted agent     BAL101553 when given together with radiation therapy in treating patients with newly     diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent     BAL101553, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy     uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted     agent BAL101553 and radiation therapy may work better in treating patients with glioblastoma.   "
2721|NCT03250286|"     The aim of this study is to demonstrate that patients with high risk of choledocholithiasis     who undergo ERCP only for patients with choledocholith in the EUS examination[EUS-ERCP group]     have less negative outcomes (including false-negative results and procedure-related     complications) than patients who undergo ERCP in all patients with high risk of     choledocholithiasis[ERCP group]. The primary outcome is the incidence of negative outcomes     (including false-negative results and procedure-related complications) in both groups. The     secondary outcomes included days of hospitalization and diagnostic yield of EUS in the     diagnosis of choledocholithiasis.   "
2722|NCT03250273|"     The proposed study is an open-label, two-arm study of entinostat plus nivolumab in patients     with unresectable or metastatic CCA or PDAC.   "
2723|NCT03250260|"     Most women with breast cancer are able to have an operation to remove the cancer while     preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most     important goal, appearance of the breast after surgery has been shown to affect the quality     of a woman's life after treatment. This is even more relevant now that most women are     surviving breast cancer.      Before surgery, women are prepared for how they will look afterwards by having a discussion     with the Surgeon or Breast Care Nurse. Sometimes women are shown two dimensional (2D)     (standard) photographs of other women who had a similar operation. Patients have stated that     viewing photographs of other patients does not prepare them adequately for their own     experience of surgery.      Three dimensional (3D) digital photography is currently being used to predict the appearance     of the breasts after enlargement surgery using specialist software. The investigators intend     to use a similar system to simulate a patient's appearance after BCT for cancer. The     investigators believe that this will lead women to feel better prepared for their surgery,     reduce stress, and lead to greater satisfaction with their breast after treatment.      This study invites women undergoing BCT to be assigned at random to one of three groups     receiving standard care (discussion), a 2D photograph, or the 3D simulation before their     operation. The investigators will find out whether women feel better prepared for surgery and     are more satisfied with their outcome if they are shown a simulated image of how their own     breasts are likely to look.      By taking 3D photographs of all study patients before and after surgery, a more accurate way     to predict appearance after surgery will be developed for future patients.   "
2724|NCT03250247|"     The purpose of this study is to determine if the use of image-guided, endovascular therapy     (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease     severity and improve quality of life in patients with established disabling iliac-obstructive     post thrombotic syndrome (DIO-PTS).   "
2725|NCT03250234|"     This investigation will examine the impact of skeletal muscle glycogen stores on skeletal     muscle and circulating microRNA expression and exogenous carbohydrate oxidation.      Primary Objective Determine the influence of carbohydrate availability (e.g., glycogen     depletion and repletion) on skeletal muscle microRNA expression, and if changes in     circulating microRNA are reflective of changes in skeletal muscle microRNA.      Secondary Objective Determine how initiation of exercise with adequate or low glycogen stores     effects exogenous carbohydrate efficiency.   "
2726|NCT03250221|"     To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy   "
4062|NCT03232684|"     The study is aimed at verifying if a pulmonologist in training can reliably assess the     adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training     provided by an experienced pathologist.   "
2727|NCT03250208|"     The study will enroll healthy pre-menopausal female volunteers in the community. These     subjects will act as their own controls. The subjects will collect voided urine and     peri-urethral swab specimens daily for several months. They will also be asked to collect     vaginal and peri-rectal swab specimens at various time points. Subjects will document various     lifestyle variables daily. During the middle of the study, subjects will be randomized to     probiotic vs placebo. Using bacterial culture and 16S rRNA gene sequencing, the study will     measure the bacterial populations of several anatomic sites longitudinally: voided urine,     peri-urethra, vagina, and peri-rectal. The study hypothesizes that oral probiotic usage will     alter the bacterial populations and ratio of Lactobacillus to E. coli within each of these     sites. Additionally, the study hypothesizes that the changes within each site will occur     first in the rectum (i.e. GI tract), followed by the vagina, and then the urethra and     bladder.      Using the prospective design of daily sampling and lifestyle variable documentation, the     study may be able to identify possible influences on microbiome stability within the sampled     sites. The lifestyle variables recorded include: diet, medication usage, menstruation, sexual     activity, and alcohol consumption.      This pilot study will establish the variance of the outcome variables among healthy women and     confirm the emergence of the probiotic with the recommended dose. With this information,     future researchers will be able to calculate the power needed for a larger randomized trial.     This trial would also randomize patients who may be at risk for a UTI to receive a probiotic     vs placebo. The primary outcome measurement will be the change in the ratio of Lactobacillus     to E. coli. As a secondary aim, the study will evaluate the incidence of UTI in the patients.   "
2728|NCT03250195|"     The aim of the study is to examine the value of the new MRI techniques (spectroscopy and     DWI), and FDG-PET in prognostication of male infertility.   "
2729|NCT03250182|"     This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI     320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed     following a single dose administration on the first treatment day (Day 1) and will be     assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to     28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at     least 5 days but no longer than 7 days after the last dose of study drug.   "
2730|NCT03250169|"     Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in     neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS     management.   "
2731|NCT03250156|"     This project aims to evaluate the effectiveness of mindfulness training (MT) on cognitive and     psychological factors when incorporated to the duty-day schedule of servicemembers (via     proctored mindfulness practice). Based on prior literature, it can be hypothesized that the     benefits of MT on measures of attention, working memory, and psychological well-being will be     greater for servicemembers who engage in proctored mindfulness practice and receive duty-day     support compared to servicemembers who practice independently, on their own time, with no     structured duty day support.   "
2732|NCT03250143|"     Fifty six patients of CRU attending the urticaria clinic in the department of Dermatology,     Venereology and Leprology at the Post Graduate Institute of Medical Education and Research,     Chandigarh will be recruited in the study calculated by using equivalence analysis assuming     power of 90%, significance level of 5% and standard deviation of 1 and adjusting 5% of     expected drop-outs after taking written informed consent. This study is undertaken with an     intention to treat the patients of chronic refractory urticaria completely. Patients will be     randomized into two groups A and B using computer generated random number tables, group A     will receive Cyclosporine and group B will receive Azathioprine; wherein, 28 random single     and double-digit numbers from 1-56 will be selected before recruitment, and patients coming     on these numbers will be randomized in a particular group. Random number generation,     recruitment and randomization, were all done by the same investigator..   "
2733|NCT03250130|"     The main objective is to assess the feasibility of an intervention based on medical     Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a     diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and     radiotherapy   "
2734|NCT03250117|"     Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the     Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant     technology where the implant is inserted under the skin. This study will measure how much     ropinirole is released in the blood during 3 months of treatment, and evaluate the side     effects of this new formulation.   "
2735|NCT03250104|"     Throughout project, the investigators design, evaluate and disseminate infection control and     antibiotic stewardship (ABS) measures aimed at reducing the incidence of Clostridium     difficile infection (CDI). The measures will focus on known departments with high incidence     of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average     infection rates, which were identified throughout previous studies. The infection control     package will include staff training, hand hygiene programs and disinfection measures.     Throughout the ABS package, investigators will develop and implement ABS measures     specifically designed for patients at the highest risk of developing hospital-acquired     infections, i.e. those treated on hematological/oncological wards. Potentially useful ABS     actions even in critically ill patients are early reduction of exposure based on     microbiological results, timely cessation of anti-infective treatment, thoughtful     implementation of screening measures and biomarkers, defined approaches to patients known to     be allergic to penicillins, and vigorous enforcement of clinical and microbiological     diagnosis of infection focus.      The IC and ABS measures aim at educating and assisting clinical personnel in realizing     treatments according to official guidelines. There will not be a direct contact between study     personnel and patient. There will be no direct recruitment of patients.   "
2736|NCT03250091|"     The project will aim to identify and determine subgroups of patients with different risks of     progression to gastric cancer and to assess appropriate follow-up intervals. Implementing     risk stratification only high risk individuals will be offered and performed endoscopic     surveillance.   "
2763|NCT03249740|"     The purpose of this study is to evaluate the safety and efficacy of single and repeated     intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular     degeneration.   "
2737|NCT03250078|"     The main goal of this study is to explore the relationship between new-onset diabetes     mellitus and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and     Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage     pancreatic cancer or precursor lesions. Individuals with a strong family history or genetic     predisposition to pancreatic cancer will also be included. Participants will be asked to     donate a blood sample at specific intervals for the creation of a bio-bank necessary for the     development of a blood based screening test for Pancreatic Cancer.   "
4063|NCT03232671|"     Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in     cardiovascular diseases when assessed in clinical routine.   "
2738|NCT03250065|"     This proposal describes the development of a 'Sensing ET Tube'. This device will replace the     standard endotracheal (ET) tube used in anaesthesia and in ventilated intensive care patients     and provide key vital signs monitoring utilising optoelectronic sensors. Continuous     monitoring of patients' arterial oxygen saturation is essential during surgery, however pulse     oximeters often misread or fail altogether as a result of peripheral vasoconstriction,     hypotension or hypovolaemia. The Sensing ET Tube will allow continuous measurement of oxygen     saturation and other parameters, such as pulse rate, from a single internal site, and will     reduce the number of surface sensors placed on the skin and the number of electrical     connections to the patient. The applicants have already developed similar sensor technology     in the oesophagus and other internal locations. A pilot clinical evaluation of the device     will be completed in anaesthetised patients undergoing surgery. The project will lead to     further development of a multi-sensor tracheal platform for comprehensive anaesthesia and     intensive care monitoring.   "
2740|NCT03250039|"     This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and     characterize plasma, fecal and urinary radioactivity and identify any metabolites, if     possible, of 14C PF-04965842 in humans. In addition, this study will provide a better     understanding of the pharmacokinetic disposition of PF-04965842 by obtaining intravenous (IV)     clearance and delineating the extent of oral absorption (absolute bioavailability (F) and     fraction absorbed (Fa)).   "
2741|NCT03250026|"     This study aims to evaluate whether a convergence dialogue during sick leave, between the     employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion     leader, leads to reduced sick leave time compared to those individuals who only have contact     with a Care Manager during the period of sick leave. The study will be performed as a     randomised controlled trial with randomisation at the PCC level where intervention PCCs     offers a convergence dialogue meeting with the work place representative during sick leave in     addition to Care Manager contact.   "
2742|NCT03250013|"     Single-centre open-label prospective study, enrolling 100 children and adolescents aged 6-17     years, who receive medication for ADHD of any subtype (presentation). Long-term results are     evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales;     WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional     Impairment Scale; WIFRS), and quality of life (Child Health and Illness Profile-Child Edition     Scale; CHIP-CE) during 24 months of ADHD treatment.   "
2743|NCT03250000|"     This study investigates the influence of acute exacerbation of chronic obstructive pulmonary     disease (COPD) on retinal microcirculation, on functional status and also investigates the     prognostic value of retinal vessel caliber assessment in terms of hospitalization and     mortality during 2 years of follow-up.   "
2744|NCT03249987|"     This piece of research is a single centre, two-way cross over, prospective study to compare     the outcomes and experience of patients completing a paper bladder diary and an electronic     version. This project aims to examine whether an electronic bladder diary can improve data     quality compared to a paper bladder diary. Participants will attend an introduction     appointment within the Urology Department at Royal Hallamshire Hospital. The participant will     complete the bladder diaries at home and will then complete a questionnaire at the Royal     Hallamshire Hospital.      Patients who are being sent an appointment for urodynamics (standard or video) will be also     sent a recruitment letter and participant information sheet (PIS), to inform them of the     study. One week later a member of the study team will phone the patient, to see if they are     interested in participating in the study and assess the eligibility criteria. If that patient     is interested and they fulfil the inclusion/exclusion criteria they will be invited to attend     an introduction appointment. This will be conducted 1-2 weeks prior to the urodynamic test,     at which point study details will be discussed and written informed consent will be taken.     The participant will be taught how to use the digital and paper versions of the bladder     diaries      Participants will be asked to complete the electronic diary for three days and the paper     diary for three days. Half of the participants will complete the digital diary first, the     other half will complete the paper diary first, and this will be done by alternating     consecutively. Patients will be asked to record the time and volume of voids, any     incontinence or urgency episodes and sleep-wake times. On the day of their urodynamics     appointment, patients should return with their electronic and paper diaries   "
2745|NCT03249974|"     1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with          a standardized breakfast test. Patients receive a standardized breakfast. The usual          insulin bolus will be administered at breakfast. After breakfast, a venous blood sample          is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time,          the glucose value shown by the sensors will be noted. A comparison of the blood glucose          value with the data recorded by the sensor can evaluate the accuracy of the sensor and          also estimate the lag-time between the sensor glucose and the venous glucose.        2. Patient satisfaction will be evaluated using a questionnaire that will be completed          after the Enlite sensor has been worn for 1 month.        3. The development of skin reactions will be checked by a short questionnaire, supplemented          with a picture of possible skin phenomena.        4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within          target,% under target, amount of hypoglycemia) in the month prior to sensor switching          will be compared to the same data recorded by the Enlite sensor during the first month          of use.   "
2764|NCT03249727|"     This study will measure the activity of natural killer (NK) cells using the in vitro     diagnostic device NK Vue in high risk subjects (Quebec risk categories P3 and P4) scheduled     for colonoscopy.   "
2768|NCT03249675|"     Concussion is widely recognized as a major public health concern in the United States and     worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4     patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS     diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked     response potential analysis have led to a novel technique for assessing brain network     activation (BNA) patterns. The purpose of this study is to explore the use of BNA in     individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent     injury.   "
4095|NCT03232255|"     This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the     treatment of dentine hypersensitivity.   "
2746|NCT03249961|"     Practice is required to improve your shot in basketball or to play a musical instrument. The     learning of these motor skills can be further enhanced by non-invasively stimulating regions     of the brain that control movements with electrical currents. These electric currents can     strengthen or weaken connections of the brain, which consequently affects a person's ability     to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely     applied in many disciplines of neuroscience research, and has potential therapeutic     application. There are two specific types of NIBS that will be used in this research study:     1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical     currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation     (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the     brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated,     painless, and safe. The application of tDCS to brain regions that control movements,     concurrently with practice of a skill, results in better skill performance, than practice     alone with no tDCS. Therefore, in this study, we will be testing different types of brain     stimulation and different amounts of practice.   "
2747|NCT03249948|"     Despite significant advances in resuscitation efforts, there are some patients who remain in     refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double     sequential external defibrillation (DSED) and vector change defibrillation have been proposed     as a viable option for patients in refractory VF. This pilot cluster randomized trial will     compare (1) continued resuscitation using standard defibrillation; (2) resuscitation     involving DSED; or (3) resuscitation involving vector change defibrillation, in patients     presenting with refractory VF during out-of-hospital cardiac arrest. The results of this     pilot study will provide critical data for planning a larger, adequately powered multi-site     randomized controlled trial to clinically evaluate DSED and vector change defibrillation     compared to standard therapy for patients in refractory VF.   "
2748|NCT03249935|"     The proposed study is a single center (with multiple long-term YCFs) treatment trial of the     CDC-recommended azithromycin regimen (1gm PO once) for chlamydia in males. This study is     designed primarily to determine the frequency of chlamydia treatment failure following     azithromycin in males who do versus do not have urethral symptoms of urethral discharge     and/or dysuria. Anticipated enrollment is 446 males with subject participation duration of 28     days and study duration of 4 years. The primary objective of the study is to assess the     microbiological efficacy of azithromycin in uncomplicated Chlamydia trachomatis infection in     males with versus without urethral symptoms in YCFs.   "
2749|NCT03249922|"     The investigators will be evaluating quality of life outcomes in patients who are undergoing     routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre     and post-operatively for quality of life improvements, pain control, and functionality.   "
2750|NCT03249909|"     Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding     wounds   "
2751|NCT03249896|"     Gestational diabetes mellitus (GDM) affects one fifth of Singaporean pregnancies and can     result in short and long term complications for mother and child. Mobile applications are     effective in improving diabetes care and weight related behaviors through improved     self-management. A multidisciplinary healthcare team from National University Hospital,     Singapore has worked with Jana Care to develop the Habits-GDM smartphone app, a lifestyle     coaching program specific for gestational diabetes. It consists of interactive lessons to     provide patient education, diet, activity and weight tracking tools, messaging platform for     coaching and motivating patients towards healthy behavior beneficial for gestational     diabetes. It interfaces with the Aina device, a novel hardware sensor that plugs into any     smartphone and can be used for glucose monitoring. This study aims to test the effectiveness     of this app in preventing excessive weight gain in pregnancy among patients with gestational     diabetes.   "
2752|NCT03249883|"     The purpose of this study is to determine whether the geriatric prosthetic foot 1M10 is     superior to the classical SACH (Solid Ankle Cushion Heel) foot, when used by indoor     ambulators with a transtibial amputation.   "
2753|NCT03249870|"     The aim of the present EWALL-INO study is to confirm very promising results obtained with a     combination of INO and mild chemotherapy in older de novo CD22+ B-ALL patients. For that     purpose, safety and efficacy of a weekly INO administration combined to mild-intensity     chemotherapy will be evaluated in a cohort of patients aged more than 55 years with newly     diagnosed previously untreated Ph-negative (CD22+) BCP-ALL. Conversely to the MDACC     miniHCVD-INO study and in order to lower the overall toxicity of the combination, INO will be     given as part of the remission induction treatment phase during the first 2 treatment cycles     only, in combination with corticosteroid, vincristine, cyclophosphamide and intrathecal     prophylaxis only; then, all responding patients will received standard INO-free chemotherapy     as consolidation and maintenance.   "
2754|NCT03249857|"     Based in an embodied approach of cognition, several studies have highlighted a direct link     between perception of an object or an emotion and the associated motor responses. This study     investigated in patients suffering from bipolar affective disorders whether the perception of     emotional words involves an automatic sensorimotor simulation of approach and avoidance     behaviors, and whether the perception of an object involves an automatic sensorimotor     simulation of object prehension (affordance). We hypothesize that, in this pathology, low     level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are     altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will     be recruited. The main objective is the emergence of sensorimotor compatibility effects in     approach-avoidance task with emotional stimuli (gain between compatible vs incompatible     conditions).   "
2765|NCT03249714|"     The study will provide efficacy, safety, tolerability and pharmacokinetics data for     ofatumumab 20 mg subcutaneous injections every 4 weeks compared with placebo for 24 weeks in     patients from Japan and the other countries and also provide the extended efficacy, safety,     tolerability and pharmacokinetics data.   "
2766|NCT03249701|"     This study investigates transcutaneous electrical acupoint stimulation (TEAS) administered in     peri-operation for preventing postoperative complications, meanwhile evaluates it's safety     and effectiveness in elder patients, who accept hip or knee surgery. Totally, three groups     are created, 1/3 participants receive TEAS, 1/3 participants receive sham TEAS, the rest 1/3     will not use TEAS.   "
2755|NCT03249844|"     Arterial ischemic stroke (AIS) is a devastating condition, affecting 1.6-5/100,000     children/year. Although their outcome is different, children with stroke do not recover     better than adults, with at least 2/3 suffering long term sequels such as developmental     (motor, global intellectual, language...) and behavioral disabilities, epilepsy, and low     adaptative and academic skills...      Stenotic cerebral arteriopathy is identified as AIS etiology in 60-80% of previously healthy     children and the course of this arteriopathy is the strongest predictor of recurrent events.     30-40% of these children have a focal unilateral cerebral arteriopathy (FCA). Childhood FCA     is suspected to be an inflammatory vessel wall pathology triggered by varicella and other     (viral) infections. As recurrences occur for the great majority in the first 6 months after     the index event, aspirin 5 mg/kg/day is recommended for at least 18 months to 2 years.      As there is a rational for using immunomodulatory drugs at the acute stage of FCA,     immunotherapies are currently used by neuropaediatricians in AIS, mainly as steroids for     children with stenosing arteriopathies. However, due to weak evidences, the literature cannot     either encourage or discourage this practice.      The long term course of children with FCA is only approach to date by retrospective studies     and controversies about outcome remain (for example, the recurrence risk on antithrombotic     treatment varies notably from quasi zero to 25%). And finally, it is shown in childhood     stroke, as well as in the global field of longstanding impairment, that parental and medical     points of view do not match consistently. Longitudinal studies are needed to deserve this     familial approach.   "
2756|NCT03249831|"     Stem cells are made in the bone marrow, and can circulate the blood stream. These blood     forming stem cells are collected from the blood stream (peripheral blood stem cells) or the     bone marrow for transplant.      Blood stem cell transplants can be used to treat patients with sickle cell disease. In the     future it is hoped that transplants may also be used to treat other health conditions like     diabetes and auto-immune disease.      Transplant is often not an option for patients with other serious medical problems and most     patients do not have a full-matched donor. Improving transplant success and reducing     transplanted-related complications (like graft versus host disease) might allow more patients     to get a transplant from a half-matched (haploidentical) donor (e.g. parent, sibling, and     daughter/son).      This research transplant is being tested in this Pilot study for the first time and is     different from a standard transplant because:        1. Haploidentical donors will be used, and        2. A new combination of drugs that does not completely wipe out the bone marrow cells          (non-myeloablative treatment) will be used to prepare the patient for transplant, and        3. Most of the donor CD4+ T cells (a type of immune cells) will removed (depleted) before          giving the transplant to the patient.      After non-myeloablative conditioning treatment and haploidentical transplant, some of the     blood cells in the recipient (patient) will be from the donor (mixed chimerism). Having the     right mix of donor to recipient T cells can help improve haploidentical transplant outcomes.   "
2757|NCT03249818|"     The purpose of this research study is to collect data from the eyes of traumatic brain injury     (TBI) patients. Patients will look at a green target that will measure the fixation of the     eye for 30 seconds. In that 30 seconds, the location of the green target will change and the     participant is to track, with their eyes, the light as best they can. The device will measure     how well fixation was maintained and the speed of the saccadic movements of the eye. Data     will then be used to determine whether there is correlation between these measures and known     TBI.   "
2758|NCT03249805|"     The aim of this study is to determine the effect of a new design of FAB type on compliance     and treatment outcomes of idiopathic clubfeet treated by the Ponseti method. Very little     literature exists on the effect of brace type or the difference between reported and actual     at-home compliance, which is integral to the success of treatment with the Ponseti method.     Eighty children less than 1 year of age will be enrolled in the study into two arms, using     block randomization. These two groups will use two different designs of foot abduction brace     (FAB). Outcomes will be measured by number of recurrences per group (using recasting and/or     surgical procedures and Pirani score as indicators), time of recurrences (in months),     compliance with brace wear using sensors and comparing the data with brace wear reported by     parents, and parent satisfaction with FAB (measured on a modified Orthotics and Prosthetics     User Sur vey). Enrollment will be on a rolling basis; subjects will be enrolled at their last     cast application and followed for approximately 6 months. Recurrences, time of recurrence,     parent satisfaction, and reported vs. actual compliance will be analyzed.   "
2759|NCT03249792|"     The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a     preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a     maximum administered dose (MAD) of MK-2118 when administered via intratumoral (IT) injection     as monotherapy and in combination with pembrolizumab (MK-3475) intravenous (IV) infusion.   "
2760|NCT03249779|"     To evaluate, in a pilot fashion, efficacy and tolerability of electrical counter-stimulation     using the Scrambler device in alleviating uncomfortable sensations and urge to move in     patients with restless legs syndrome/Willis Ekbom Disease (RLS/WED).   "
2761|NCT03249766|"     Thoracic surgeries are associated with significant operative trauma1. While thoracic epidural     analgesia may help control the incisional component of the pain, an excruciating     postthoracotomy. Ipsilateral Shoulder Pain (ISP) could under mine pain management in the post     thoracotomy patient2. The incidence of ISP ranges from 21% to 97%3. ISP impairs respiration,     mobility, and physical therapy in the early postoperative period4. The etiology of ISP is     unclear. Several hypotheses have been proposed as possible causes of ISP, including     transection of a major bronchus, ligament distraction by surgical retraction, shoulder joint     strain as a result of intraoperative positioning, pleural irritation due to the thoracostomy     tube, and referred pain from irritation of the pericardium or mediastinal and diaphragmatic     surfaces2, 5, 6. ISP is defined as the pain occurring on the operated side of thoracic     surgeries in the immediate postoperative period as early as one hour after surgery6,of dull     aching, stabbing, burning, electric or throbbing nature of moderate to severe intensity and     resistant to treatment, most commonly located in the region of the deltoid muscle or on the     posterior or superior surface of the arm or above ⅓ of the lateral part of the clavicle on     the anterior surface of the chest, lasting 3-4 days2, 7-11.The primary objective of this     study is to find out the prevalence of ISP and the risk factors associated with it.   "
2770|NCT03249649|"     The focus of this project is to elucidate the gaps in care and enhance the provision of     FGC-related health care and social services for women in Arizona who have experienced FGC;     engaging the Somali and Somali Bantu communities. As of 2012, Arizona ranked 7th in the US     for Somali refugee resettlement. The Refugee Women's Health Clinic (RWHC) is a nationally     recognized best practice model for refugee women's health, providing specialized care for     women with FGC. The project will accomplish four outcomes throughout its three-year duration:     1: Identify specific FGC-related health care needs and available health and social services     for women in Arizona who have experienced FGC to improve services to FGC-affected     communities; 2: Identify gaps, barriers, and/or assets in FGC-related health care and social     services for women in Arizona who have experienced FGC to provide improved services to     FGC-affected communities; 3: Create and implement FGC education efforts so that providers     improve culturally competent care for women who have experienced FGC in health care and     social service settings; and, 4: Create and implement community outreach and educational     programs among communities affected by FGC to increase awareness of FGC-related health     issues, prevention and services available. To inform these initiatives, an established     infrastructure exists through the Refugee Women's Health Community Advisory Coalition     (RWHCAC), a team of more than 60 stakeholders from various local ethnic organizations,     refugee resettlement and voluntary agencies, mental health and social services agencies, and     academic partners and including local voluntary resettlement agencies (VOLAGs) and Ethnic     Community-Based Organizations (ECBOs). RWHCAC will be (a) involved in the planning/design of     the project, (b) encouraged to assume responsibility to identify additional Community     Mobilizers, (c) engaged in aligning educational material content to cultural standards, and     (d) engaged in evaluating the project processes and outcomes.      Project strategies include: (1) identifying specific FGC-related health care needs and     available health and social services for FGC-affected women including identification of gaps,     barriers, and/or assets in FGC-related care (year 1); (2) utilizing results from the     Community Health Needs Assessment (CHNA) to refine existing educational materials and     implement educational outreach efforts across the state to improve culturally competent care     among providers (years 2 and 3); (3) promoting outreach and education among FGC-affected     communities through development of culturally appropriate materials and community education     sessions (years two and three); and, (4) partnering with Arizona Department of Health     Services, the University of Arizona, and African Women's Health Center, Brigham and Women's     Hospital during year 2 to deliver inter-professional training workshops for health and social     service providers on FGC, and with Johns Hopkins University for FGC teleECHO™ video     conferencing clinics to promote sustainability via links to online resources, educational     materials, and webinars (years 2 and 3). Emergent products include online learning     components, community education sessions, FGC teleECHO™ sessions, and capacity building     trainings for all partners.   "
2771|NCT03249636|"     Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the     overproduction and accumulation of cancerous, immature white blood cells, known as     lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as     red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating)     to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak     incidence at 2-5 years of age and another peak in old age.   "
2772|NCT03249623|"     Patients residing in the intensive care unit typically receive mechanical ventilatory     support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has     been shown that lung protective settings can reduce mortality in patients with lung injury.     Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a     minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of     ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The     duration of mechanical ventilation is also an important factor in weaning from ventilatory     support, with prolonged ventilator support making the weaning process more difficult.      The purpose of this study is to compare mechanical ventilation following advice from the     Beacon Caresystem to that of standard care in general medical intensive care unit (ICU)     patients, from the start of requiring invasive mechanical ventilation until successful     extubation. The Beacon Caresystem will be compared to standard care to investigate whether     use of the system results in similar care or reduced time for weaning from mechanical     ventilation.   "
2773|NCT03249610|"     Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely     unexplored. The aim of this study was to assess impact of the multi-component interventions     on body weight, body fat patterning and cardio-metabolic risk factors in overweight     individuals working in corporate worksites in New Delhi, north India.   "
2774|NCT03249597|"     Sepsis is a condition with a high mortality. Septic patients are frequently difficult to     identify because of their non-specific presentations. There is also a low sensitivity of     clinical judgment among health care personnel, and of existing screening tools, which are in     turn typically based on vital parameters. Despite prior research, no unique sepsis biomarker     has been identified so far.      There is a need for new strategies to identify sepsis which do not rely on vital parameters     and traditional laboratory blood tests alone. The hypothesis of the investigators is that a     combination of clinical variables measurable in the ambulance can be used to predict sepsis.      The aim of the current study is to determine the predictive value of keywords related to     symptom presentation, vital parameters and point-of-care (POC) blood tests, alone and in     combination, with respect to the outcome sepsis.      The study is performed in the Stockholm ambulance setting from April 2017. A total of 648     adult non-trauma patients will be included.   "
2775|NCT03249584|"     This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.   "
2788|NCT03249415|"     Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes;     some causes result from issues related to the endometrium. Unfortunately, no cure exists for     medical conditions resulting in the destruction of the endometrium, or for non-functional     uterus. Thus, safe and effective therapies are needed to treat these diseases and to     establish fertility in affected women. These novel techniques refer to the use and     application of regenerative/paracrine factors to regenerate the endometrium in patients with     Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the     injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP)     from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution     and/or effect in the endometrial repair by functional proofs.   "
2789|NCT03249402|"     The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of     JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination     oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy     female adult partcipants.   "
2793|NCT03249350|"     The ultimate goal of this research is to facilitate rapid enhancement of youth substance     abuse treatments by determining the key mechanisms of change (i.e., what to target more     intensely to generate better outcomes). This work is critical because current outpatient     adolescent substance abuse treatments yield only small to medium effects that diminish once     treatment has ended. The proposed modern mediation study will address this serious public     health problem by experimentally evaluating the most critical factors causing change in     client outcomes during adolescent substance abuse treatment, directing the field to focus     treatment efforts on those factors.   "
2817|NCT03249038|"     Estimated blood loss is an important parameter recognized as a standard practice in     anesthesiology and others medical specialties, with relevant clinical and research     applications. Currently is no model capable of accurately estimate blood loss. The purpose of     this study is to evaluate the accuracy of a novel model.   "
2776|NCT03249571|"     PURPOSE:        1. PRIMARY: Using a randomized, parallel group design, this investigation will determine if          the combination of 2-weeks polyphenol supplementation (using the Reoxcyn flavonoid          supplement in capsule form) and one acute 45-minute brisk walking bout enhances the          translocation of gut-derived phenolics into the circulation. A comparator group of          runners (N=20) ingesting the flavonoid supplement for two weeks will be included (2.5 h          run, 70% VO2max).        2. SECONDARY: Data from this study will determine if 2-weeks supplementation of the Reoxcyn          flavonoid supplement is a sufficient time period to increase circulating levels of          gut-derived phenolics, extending data collected from the previous 12-week community          trial.      HYPOTHESIS: We hypothesize that an acute 45-minute brisk walking exercise bout (60% VO2max)     following 2 weeks of increased polyphenol intake will be a sufficient exercise stimulus to     increase gut permeability and the movement of gut-derived phenolics into circulation. If this     hypothesis is confirmed, these data would have broad public health appeal, demonstrating that     the combination of brisk walking and increased polyphenol intake augments circulating levels     of health-restoring small phenolic molecules derived from bacterial breakdown in the colon.   "
2777|NCT03249558|"     A double-blind, randomized, and placebo-controlled clinical study examining whether     duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), could enhance opioid     analgesia and reduce overall opioid use. Positive outcomes will help improve the overall     effectiveness of clinical opioid therapy and reduce unnecessary opioid dose escalation.   "
2778|NCT03249545|"     Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally     acutely abolition of PVC at the time of ablation accepted as successful ablation. However in     some patients this effect occurs lately. In this study investigators sought late effect of     ablation   "
2779|NCT03249532|"     Online hemodiafiltration confers a reduced mortality risk. However, it is not clear why HDF     improved survival. To gain more insight in this issue, the effect of 4 dialysis techniques     (differing in dialysate temperature and the absence/presence of convective clearance) on     intradialytic hemodynamic stability and cardiac function will be investigated in a     prospective cross over trial.   "
2780|NCT03249519|"     The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for     advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and     chemosensitive effect of an additional hyperthermia might improve the clinical outcome.   "
2781|NCT03249506|"     The purpose of this study is to identify and evaluate the event rate of the composite     endpoint of all-cause mortality (ACM) or hospitalization for heart failure (HF) for     participants with Type 2 Diabetes mellitus (T2DM) and established cardiovascular (CV) disease     among new users of sodium-glucose co-transporter 2 inhibitor (SGLT2i) as compared with new     users of non-SGLT2i anti-hyperglycemic agent (AHA).   "
2783|NCT03249480|"     To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with     growth hormone deficiency, as well as to study the dosage of PEG Somatropin.   "
2784|NCT03249467|"     The purpose of the study is to develop a validated French version of the HAQ-II questionnaire     for rheumatoid arthritis.   "
2785|NCT03249454|"     The purpose of the study is to investigate the effects of a novel therapeutic approach with     transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and     spasticity in chronic spinal cord injury (SCI).   "
2786|NCT03249441|"     This study aims to explore the effectiveness of a group psychotherapy intervention using     Compassion-Focused Therapy (CFT) in adults with severe obesity. In particular, it aims to     evaluate the principle that CFT can be used to reduce levels of shame and self-criticism in     adults with severe obesity      OBJECTIVES:      The objective of the current study is to assess and compare a CFT group intervention to     Treatment as Usual (TAU) with regard to psychological functioning, specifically     self-compassion, shame, self-criticism, emotional eating and mood.   "
2787|NCT03249428|"     Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco     use rate has substantially gone down in the general population, significant differences exist     between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk     for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the     rest of the Canadian general population. This stark inequity in tobacco use translates into     devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart     disease and death. Canadians who are homeless or at-risk for homelessness die 25 years     earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use     related inequity - a novel approach is urgently needed. Despite commonly held dogma that     People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that     in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led     community-based action approach used in their PROMPT project has demonstrated that tobacco     dependence strategies can be implemented with great success in this population. The majority     of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all     other drug use. Importantly, the investigators have demonstrated that it is possible to gain     the trust and engagement of marginalized populations and that researchers can create a     community space that is low-threshold, safe and non-judgmental. The investigators aim to     compare two tobacco dependence management strategies in the homeless (or at-risk for     homelessness) multi-drug use population in Ottawa and Toronto. They will use the same     peer-led approach in PROMPT with community peer researchers with lived experience; with the     hope that the cost-effective community based framework derived from this trial will serve as     a template for interventions and treatments in community settings for chronic diseases such     as obesity and diabetes.   "
2790|NCT03249389|"     This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of     adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast     cancer.   "
2791|NCT03249376|"     The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,     parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I     or Bipolar II disorder having a major depressive episode.   "
5673|NCT03211637|"     Evaluate the process for implementing a wound protocol for lesion control and     cost-effectiveness in the context of the Family Health Strategy in the city of Santa Cruz do     Sul, Brazil.   "
2792|NCT03249363|"     The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical     Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of     PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach.     To confirm and better assess the efficacy of intraoperative irrigation on the infection rate     in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular     tissue before and after irrigation of the wounds   "
4108|NCT03232086|"     Purpose: To determine whether exposure to levels of fine particles that are close to the     current standard will cause cardiovascular changes in healthy individuals.   "
2794|NCT03249337|"     In brief, the objective of this study is to investigate whether the drug Glanatec ® which is     approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs     endothelial dystrophy who have had a descemet stripping procedure without endothelial     keratoplasty. While some limited data exists as a proof of concept in in vitro or animal     studies, and Glanatec® has been successfully used in a recently published case series for     this indication, there is insufficient data to show that this drug can be effectively used     for corneal cell clearing while maintaining patient safety.      The goal of the study is to provide sufficient proof of concept for the use of this drug in     patients with FED whose only treatment alternative is to undergo corneal transplant.   "
2795|NCT03249324|"     Women with pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy,     and children who experience rapid and excess growth during the first year of life are all at     risk for subsequent obesity. The purpose of this study is to examine creative cognitive     strategies to promote healthy weight gain during pregnancy, creating a sound substrate of     metabolic programming for the critical first six months of life. A trans-disciplinary     approach utilizing a patient- and family-centered intervention and active patient engagement     with counseling for positive gain will work with women to shape lifestyle during pregnancy     and postpartum, and when feeding their infants in the first 6 months of life. It is     hypothesized patient engagement with counseling for positive gains will successfully mitigate     excess weight gain in both pregnancy and infancy compared to usual care. Moreover, data will     be examined to assess whether psychological variables, work and school climate, and social     support factors influence body weight gain trajectories and/or weight loss during and after     pregnancy.   "
2796|NCT03249311|"     Levomilnacipran is an antidepressant currently approved in Canada to treat Major Depressive     Disorder (MDD). Thirty-six healthy male participants will receive escalating doses of     levomilnacipran, duloxetine, or placebo every 7 days (+/- 1 day) throughout a 20 - 28 day     period. After each dose escalation study participants will be asked to come to the clinic to     conduct the necessary tests - these will include tyramine pressor tests as well as blood     draws. The results of this study will allow the investigators to determine the dose(s) of     levomilnacipran at which reuptake inhibition of norepinephrine and serotonin (chemicals     utilized by nerve cells to transmit information to other cells) is achieved.   "
2797|NCT03249298|"     Fluid optimization in neurosurgical patients has an important impact on preservation of     cerebral perfusion pressure and minimization of cerebral oedema during and after the     craniotomy. The investigators would like to know if crystalloids or colloids are equally     useful for goal directed therapy in this patients. The investigators will record haemodynamic     stability, volume loading and postoperative complications and compare two groups of patients.     One group will be optimised with crystalloids and the second with colloids. The investigators     will compare also hospital stay and mortality in the two groups.   "
2798|NCT03249285|"     This is a pharmacogenomic prospective , four-arms, parallel groups, active comparator     controlled study in essential hypertensive patients never treated before.      Each patient will be genotyped for SNPs (single nucleotide polymorphism) in preliminary     genetic profiles and will be treated according to their genetic profile with Peri     (Perindopril) 4 mg or HCTZ ( hydrochlorothiazide) 12.5 mg.   "
2799|NCT03249272|"     The aim of this study is to assess microvascular function as determined by a cardiovascular     magnetic resonance measurement of whole-heart (global) perfusion reserve. The goal is to     determine the prevalence of MVD in two common forms of non-ischemic cardiomyopathy,     hypertrophic cardiomyopathy (HCM) and idiopathic dilated cardiomyopathy (IDCM). The     hypothesis that an optimized technique will provide robust detection of MVD and that a     multifaceted approach will provide new insights into the pathophysiology of MVD, including     the influence of myocardial scarring upon the presence and severity of MVD.   "
2800|NCT03249259|"     In this study, the investigators are going to investigate the efficacy of choline alfoscerate     on improvement of cognitive function assessed by MMSE compared to plaebo.   "
2801|NCT03249246|"     The prevalence and mortality of sepsis in Turkey is not know at large. Turkish Society of     Intensive Care Medicine, Sepsis Study Group conducted a multi-centre,point prevalence survey     to determine the prevalence, causative micro-organisms and outcome of sepsis in Turkish ICUs.   "
2802|NCT03249233|"     The purpose of this study is to investigate changes in the corneal thickness of scleral     contact lens wearers in a keratoconic (KC) population and compare to age-matched controls.     The hypothesis is that scleral contact lens wear is associated with low levels of corneal     hypoxia including measurable changes in corneal thickness. Corneal thickness will be altered     post scleral lens wear compared to pre-lens wear and the amount of alteration will correlate     to the fitting characteristics in the central zone of the scleral lenses. We propose to take     a sample of keratoconic and control participants, fit them in scleral lenses, and to measure     topographic corneal thickness after 8-10 hours of scleral lens wear after two weeks of wear,     to compare two instruments in the measurement of corneal thickness, and to compare the     effects of varying central corneal clearance of the scleral lens on corneal thickness.   "
2803|NCT03249220|"     Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the     measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain     temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured     patients.   "
2804|NCT03249207|"     This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration     twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves     clinical outcome as measured by ordinal shift in mRS at 6 months.      Patients with SAH transferred to a neurosurgical centre will be identified and approached for     study participation. Following consent, patients will be randomised to receive either IL-1Ra     or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be     non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood     samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post     randomisation for IL-6 & IL-1 measurement. Safety will be measured at 30 days post     randomisation and outcome assessed at 6 months post randomisation.   "
2833|NCT03248830|"     The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb)     compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart     disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to     acyanotic children.   "
2805|NCT03249194|"     The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus     (HCV) has changed the landscape of HCV therapy dramatically in the last several years with     reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV     positive patients including those who have received liver or kidney transplants. Since these     new regimens do not include interferon and have already been studied in the post-liver and     kidney transplant setting, they now offer a unique opportunity to expand the donor pool and     improve the lives of those awaiting renal transplant. The address this gap in knowledge, the     investigators hypothesize that pre-emptive treatment with a direct acting anti-viral HCV     medication to cure HCV soon after transplant would allow for safe transplantation of HCV     positive kidneys in disadvantaged and needy HCV negative kidney recipients with acceptable     risks and improved survivals compared with historical cohorts.   "
2806|NCT03249181|"     To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late     pregnancy.      An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens     for women commencing cART in late pregnancy. HIV positive pregnant women presenting with     untreated HIV infection in late (≥28 weeks gestation) pregnancy will be randomised 1:1 to     receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV     + 2 NRTIs (SoC)   "
2807|NCT03249168|"     Despite recent advances in minimal invasive surgery, postoperative pain control remains a     challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious     favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is     minimally invasive, has less pain, and needs less postoperative analgesic use compared with     open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure   "
2808|NCT03249155|"     The target of this clinical trial is Freezing of Gait symptom (FoG), and associated falls.     The project is aimed to evaluate the effects of an innovative experimental protocol to treat     Parkinson (PD) Patients with FoG. This new physiotherapy protocol is based on the recovery of     the correct mental representation of the movement, through Action Observation. A method that     can facilitate the process of re-learning correct motor strategies, and at the same time     avoid the phenomena of external cues dependency. Our version of the Action observation method     uses video-clips of gait exercises. In these video-clips the audio part was obtained with the     sonification of the kinematics of the body movements. We postulate that action observation,     through the activation of the mirror system, is able to reactivate stored motor programs     concerning walking ability, which can be used to facilitate recovery of defective motor     control and overcome freezing of gait. Moreover, given that patients with PD and FoG may have     major shortages of attention resources, a multisensory approach (audio-visual) would help to     further reduce the attention load, facilitating learning processes. Therefore half of     participants received an experimental protocol with Action Observation plus signification     while the other half received a traditional protocol combining visual and auditory cues.   "
2809|NCT03249142|"     This is a randomized, open, comparative, multi-centre study which will recruit up to 66     patients. The objective is mainly to explore the safety and feasibility in neo-adjuvant     first-line ovarian cancer (including patients with primary peritoneal or fallopian tube     adenocarcinoma) of various combinations of durvalumab with chemotherapy with or without     tremelimumab.   "
2810|NCT03249129|"     The purpose of the study is to detect the presence of autoantibodies and autoantigens in     cerebrospinal fluid early (<48 hours) following spinal cord trauma.      The study also aims to define the central or peripheral origin of autoantibodies by looking     for their simultaneous presence at the blood level and to evaluate the prognostic value of     the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial     clinical severity than on the recovery potential.   "
2812|NCT03249103|"     The primary objective is to determine whether daily dosing with NYX-2925 changes markers of     central pain processing in subjects with fibromyalgia by evaluating changes in evoked pain,     and visual stimulation, functional magnetic resonance imaging (fMRI), resting state function     connectivity magnetic resonance imaging (rs-fcMRI) and proton magnetic resonance spectroscopy     (H-MRS) in fibromyalgia subjects on active drug versus placebo.   "
2813|NCT03249090|"     The current study is designed to test nationally whether patients' outcomes and utilization     of services can be improved through symptom monitoring via patient-reported outcomes between     visits.   "
2842|NCT03248713|"     The purpose of this protocol is to examine whether mifepristone, a medication with     glucocorticoid receptor antagonist activity, may be a potential treatment for Tobacco Use     Disorder (TUD). Mifepristone has already shown promise as a potential treatment for PTSD (1)     and alcohol use disorder (AUD) (2), but no previous studies have examined the therapeutic     potential of mifepristone for TUD. This will be a double-blind, placebo-controlled study on     the effects of a 7-day treatment with 600 mg mifepristone, or placebo, on cognitive function,     tobacco withdrawal severity, and smoking behavior.   "
2815|NCT03249064|"     This study aims to evaluate some differences in the immune system between patients with     vitiligo and patients without the disease.      These differences will be evaluated by the extraction of peripheral blood that will be     analyzed before the treatment and after the treatment that, in the habitual way and at the     discretion of the responsible dermatologist.      Patients agreeing to participate in the study will be subjected to extraction of two tubes     (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.      Therefore, neither treatment nor follow-up visits will be modified by participation, but will     be the same whether or not participate in the study.      In the case of controls, two peripheral blood tubes (20ml) will be removed in a single     participation.      Patients with vitiligo will also be asked to complete questionnaires to measure stress,     depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12     weeks (+/- 5 days) of therapeutic intervention .      This study will include 20 patients with active non-segmental vitiligo and 10 controls     without the disease. The duration of participation in this study will be 12 weeks (+/- 5     days) for patients with vitiligo and a single participation (extraction of 20 ml of     peripheral venous blood) for the controls.   "
2816|NCT03249051|"     The aim of this study is to investigate whether an individualized determination of energy     requirements using indirect calorimetry instead of a formula-based approach leads to an     optimized nutritional support and as a consequence to an optimized nutritional status of the     critically ill, mechanically ventilated patients measured by the phase angle.   "
2818|NCT03249025|"     Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with     actual or potential tissues damage, or described in terms of such damage. It is estimated     that 1 in 5 Canadians experience chronic pain Chronic pain is associated with the worst     quality of life compared with other chronic diseases such as chronic lung or heart disease.     Many of these problems are confined to a specific anatomic structure, and can be diagnosed     and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals     experience a more generalized pain. This condition has also resulted I depressed mood, bad     relations with other people, sleep disturbances and poor quality of life.      The condition is very difficult to manage, and multiple methods have been recommended.     Therapeutic intravenous infusion may be considered as one of these methods. Patients come for     infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two     most commonly used mediation are lidocaine and ketamine.      Even though it is common to use multiple medications with complementary mechanisms of action     to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the     purpose of this research study is to determine whether mixture of two medications (ketamine     and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of     pain unpleasantness.   "
2819|NCT03249012|"     This study aims to compare two different protocols commonly used in the management of post     thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The     investigators aim to compare the quality of life associated with these two protocols in a     randomized trial.   "
2820|NCT03248999|"     This study evaluates individual and collective factors of ESBL and CRE carriage in nursing     homes.   "
2821|NCT03248986|"     A single-center, observational, prospective, single dynamic cohort study with before-after     design. Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for     Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with     stroke. Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS),     functionality with the Fugl-Meyer scale for the upper limb, pain by 10-points visual analogue     scale (VAS10) and the quality of life with the Euro QoL 5D survey.   "
2822|NCT03248973|"     Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of     Pregnancy   "
2823|NCT03248960|"     The primary purpose of this study is to validate the sensitivity and specificity of the     iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B     as compared to viral culture.      The secondary aims are to:      Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu     A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase     Polymerase Chain Reaction (RT-PCR).      Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with     influenza-like symptoms.      Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the     iTreat Flu A+B Test.      Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.   "
2824|NCT03248947|"     This pilot study examines the feasibility and acceptability of transitioning office-based     buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from     this study will inform the development of a future multi-site randomized clinical trial.   "
2825|NCT03248934|"     The primary objective of this study is evaluate the diagnostic accuracy of a patient     self-administered clinical examination of the hip compared with a traditional clinical     examination (i.e. index test).   "
2826|NCT03248921|"     The purpose of this study is to identify measures of obesity, functional capacity, and     specific biomarkers that may be predictive of obesity and post-operative outcomes.   "
2827|NCT03248908|"     In this double blinded randomized controlled study, the pupillary dilation reflex is used for     as a nociceptive indicator for opioid administration during elective surgery under general     anesthesia.   "
2828|NCT03248895|"     Mobilte Direct Observation Therapy (MDOT) is a technology has the potential to be a cost     effective approach to direct observation of therapy administration, the latter being one of     the most accurate methods of evaluating adherence. Use to date, as confirmed by the rapid     systematic review, has been limited mainly to TB and sickle cell disease and there have been     no published reports on the use of MDOT to monitor inhaled therapy. Due to the increasing     incidence of childhood asthma worldwide, there is a need for new innovative approaches to     support children and their parents with asthma management, especially since national and     international guidelines have advised healthcare providers to periodically assess inhaler use     as part of asthma management.   "
2829|NCT03248882|"     Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)   "
2830|NCT03248869|"     Mobile health applications (MHA) are increasingly being explored as tools to assist in     management of chronic diseases. Little is known regarding which characteristics of MHAs are     effective and there is limited data suggesting a real-world impact on health outcomes. Asthma     is one of the most common and costly of the chronic diseases, impacting a broad range of the     population including both children and adults. It is a variable disease necessitating regular     medication use, monitoring of symptoms, and avoidance of specific triggers. These     characteristics of asthma make it a chronic disease that is particularly amenable to having     an MHA facilitate active monitoring outside of periodic traditional medical visits. The study     team has designed a MHA focused on asthma subjects to test the feasibility of an asthma     mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between     MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research     design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical     care (that may take place during typical office visits), such as medication reminders, a     daily asthma diary to track asthma control (AC) and medication use, patient education and     assessments of quality of life (QoL), and health care utilization (HCU).   "
2831|NCT03248856|"     In this study Triamcinolone acetonide will be applied intratympanically before cochlear     implant surgery. After round window exposure, a perilymph sample and simultaneously a blood     sample will be drawn. Triamcinolone levels will then be analyzed in the samples.   "
2832|NCT03248843|"     This is an open label, dose escalation study to evaluate the safety and tolerability of KN035     in Japanese patients with advanced and metastatic solid tumor. The dose escalation will     follow the widely used 3+3 design.   "
2835|NCT03248804|"     Dietary protein is a key element of most effective weight loss regimens. This study will     investigate the effects of consuming soy protein on body composition and cardiometabolic     health within the context of an effective weight loss and maintenance program called the     Colorado Diet.   "
2836|NCT03248791|"     Comparison will be conducted between continuous variable infusions of both drugs     (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min     respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.   "
2837|NCT03248778|"     Specific aims of the 1-year project are to pilot test the disclosure support intervention by     (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10     HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and     (b) assessing outcomes in mothers (quality of life and mental health indicators, adherence,     social support, and disclosure stress, efficacy, readiness, and completion). The intervention     will be compared to treatment as usual, with baseline (0 weeks), immediate post-intervention     (4 weeks), and 12-week follow-up (16 weeks) assessments.   "
2839|NCT03248752|"     The purpose of this study is to examine the effect of monitoring and sharing physical     activity outcomes (using Fitbit technology) on physical activity participation in those who     have received an exercise prescription from their physician.      Primary research question: Does shared physical activity outcomes from wearable technology     with a participant's physician improve overall physical activity over 3 months compared to     shared outcomes with a family member, unshared outcomes (normal wearable technology     condition), and a control group (no wearable technology condition) following an exercise     prescription from one's physician? Physical activity will be measured as minutes of moderate     to vigorous physical activity per week.      Hypothesis: Knowledge that physical activity outcomes will be shared with a participant's     physician will serve as a proxy-supervision intervention and improve physical activity     adherence in comparison to all other groups. Self- and partner shared outcomes conditions     will be more effective than the control group.   "
2840|NCT03248739|"     A randomized trial comparing small versus large catheters in terms of occlusion and need for     replacement to confirm differential occlusion risk based on catheter size. This study will be     done to determine whether external ventricular drain catheter diameter has any effect on risk     of occlusion.   "
2841|NCT03248726|"     Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed     that adenoma detection rate positive correlation with good bowel preparation which makes     bowel preparation an important issue. Hence, investigators conduct a clinical trial about     adding another laxative agent to morning single dose low-volume PEG. To see if this new     regimen could have non-inferior efficacy and lower life/sleep impact compared with standard     regimen.   "
2843|NCT03248700|"     Women were given a vitamin A tracer, and blood was sampled to determine individual and group     vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine     effects of study length on model outcomes.   "
2845|NCT03248674|"     Patients with chronic kidney disease (CKD) before kidney transplantation require that     obstructive coronary artery disease (CAD) is excluded, as cardiovascular complications are     the leading cause of mortality in kidney transplant patients. However, in this patient     population, the optimal method for the detection of obstructive CAD has not been identified.     Noninvasive stress tests such as Dobutamine stress echocardiography or nuclear perfusion     study have low diagnostic accuracy. CT fractional flow reserve measurement (CT FFR) is a     novel non-invasive (FDA approved) imaging test to identify obstructive CAD. The goal of this     project is to evaluate the diagnostic accuracy of CT FFR in the detection of obstructive     coronary artery disease in patients with chronic kidney disease before kidney     transplantation.   "
2846|NCT03248661|"     This study will randomly assign 220 men and women to either a social media intervention or a     standard reminder system to have a repeat screening test for colo-rectal cancer.   "
2847|NCT03248648|"     To compare the efficacy of intra-articular administration of neostigmine versus ketamine as     adjuvant analgesics after knee arthroscopy.   "
2850|NCT03248609|"     Investigate the postprandial glycemic responses of healthy individuals when consuming     commercially available table grape varietals or grape juice, compared to a standard amount of     glucose.   "
2851|NCT03248596|"     The aim of the study is a better understanding of hemorrhagic events causes in patients with     ECMO, prevent them and decrease the number of transfusion.   "
2852|NCT03248583|"     Individuals living with food insecurity are disproportionately affected by overweight and     obesity and associated chronic health problems. There remains a lack of sustainable and     scalable interventions targeting widespread barriers to access to healthy foods in this     population to increase the nutritional quality of foods purchased for preparation and     consumption at home.      This randomized controlled proof-of-principle trial was designed to examine the feasibility     and initial efficacy of a default option in enhancing the nutritional quality of groceries     selected via the online shopping service of a local grocery store under conditions that mimic     the financial constraints typical of individuals living with food insecurity.      In behavioral economics, the default option refers to the option a consumer selects if no     active choice is made. The notion of the default option is based on the concept of     asymmetrical or libertarian paternalism, which seeks to subtly shift consumer behavior in     a manner that promotes welfare, but without overtly interfering with the individual's freedom     to choose.      It was hypothesized that the default option effectively increases the nutritional quality     of foods purchased online, compared to monetary incentives and psychoeducation about     nutrition.      Female undergraduate students (n = 60) selected food for one week using the online shopping     service of a local grocery store with a budget corresponding to maximum weekly Supplemental     Nutrition Assistance Program (SNAP) benefits. Before completing the task again, participants     were randomized to: (1) a small monetary incentive for selecting groceries that meet     nutritional guidelines (n = 17), (2) an educational brochure (n = 24), or (3) a default     pre-filled online shopping cart containing a nutritionally balanced selection of groceries to     which they could freely make changes (n = 18).      Primary outcome measures capture the nutritional quality of groceries selected/ purchased.   "
2853|NCT03248570|"     This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic     castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.   "
2891|NCT03248076|"     Opioids is known that produce not only analgesia but also hyperalgesia through activation of     central glutaminergic system-GABA. At the same time, recently it was found that the main     opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their     antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production     via OPRM1, causing ovarian hyperstimulation syndrome.      This study aims to investigate if a single exposure to opioids is enough to produce     activation of stress mechanism during oocyte retrieval.   "
2895|NCT03248024|"     The objective of this study is to analyze the factors influencing the medical and non-medical     direct costs of patients treated with biotherapy during the last twelve months (infliximab or     adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for     treating Crohn's desease or ulcerative colitis   "
2854|NCT03248557|"     Ventricular fibrillation (VF)-related sudden cardiac death (SCD) is a leading cause of     mortality. Patients may survive with neurological damage despite state-of-the-art treatment.     Current biological and imaging parameters show significant limitations on early predicting     cerebral performance at hospital admission. A spectral-based model was recently suggested to     correlate time-dependent VF spectral changes with acute cerebral injury in comatose survivors     after cardiac arrest, which opens the possibility to implement early prognostic tools in     clinical practice. The AWAKE trial is an investigator-initiated, multicenter, observational     trial aiming to validate a spectral-based model to early predict cerebral performance and     survival in resuscitated comatose survivors admitted to specialized intensive care units. The     primary clinical outcome is favorable neurological performance (FNP) during hospitalization.     Patients will be categorized into 4 subsets of NP according to the risk score obtained from     the predictive model. The secondary clinical outcomes are survival to hospital discharge, and     FNP and survival after 6 months of follow-up. Model-derived categorization will be compared     with clinical outcomes to assess model sensitivity, specificity and accuracy. Eligible     patients will be included prospectively and retrospectively, using an electronic Case Report     Form to enter data from medical records and in-person interviews. Patients will be divided     into: study group (predictive data required) including comatose (Glasgow Coma Scale -GCS- ≤8)     survivors undergoing temperature control after return of spontaneous circulation (RoSC), and     control group including patients who regain consciousness (GCS=15) after RoSC. VF tracings     prior to the first DC shock will be digitized and analyzed to derive spectral data and risk     scores.   "
2855|NCT03248544|"     Vitamin D supplementation not only has beneficial effects on morbidity and mortality in     critically ill patients but it may also lead to alleviate of seizure, brain edema, infection,     pain and some other perioperative complications, possibly in part through an attenuation of     the immune response.In this trial patients with brain tumor under craniotomy will receive a     single high dose vitamin D compared to control group.   "
2856|NCT03248531|"     Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses     and scarring on the skin.   "
2857|NCT03248518|"     Fatigue is common and disabling for most patients with inflammatory rheumatic disease.     Therapies designed to improve physical activity and 'talking' treatments, which positively     help patients change the way they think and behave, are both helpful in reducing the burden     of the fatigue. However, few patients have access to these treatments in most health     services. This situation results from the absence of standardised programmes and limited     availability of relevant therapists.      The investigators aim to enhance access to fatigue alleviating physical activity and talking     therapies by testing innovative,standardised and cost-effective approaches to treatment     delivery.      The investigators will also use this opportunity to understand how to select the best     treatment for a patient based on their individual profile and to better understand how these     treatments actually work. This in turn may lead to more refined and effective therapies in     the future.   "
2858|NCT03248505|"     This study aim analyze the immediate effects of conventional transcutaneous electrical nerve     stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with     non-specific low back pain.      All subjects will be submitted to an evaluation of the painful sensation, through the     numerical rating scale, and pain threshold, through algometry, before, immediately after the     intervention and 25 minutes after.   "
2859|NCT03248492|"     Some HER-2 breast cancer patients do not respond or build resistance to current treatment.     DS-8201a is a new experimental product that is a combination of an antibody and a drug. It     has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve     outcomes for these patients.   "
2860|NCT03248479|"     This trial will evaluate Hu5F9-G4, a monoclonal antibody which is designed to block a protein     called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may     enable the body's immune system to find and destroy the cancer cells. In this study, Hu5F9-G4     may be given alone or in combination with azacitidine to patients with acute myeloid leukemia     (AML) or higher risk myelodysplastic syndrome (MDS). Azacitidine is a drug used for treatment     of AML or MDS in patients who are not eligible for typical chemotherapy.      The major aims of the study are: to confirm the safety and tolerability of Hu5F9-G4     monotherapy in a relapsed/refractory AML and MDS population, and of Hu5F9-G4 in combination     with azacitidine in previously untreated AML and MDS; and to evaluate the efficacy of     Hu5F9-G4 monotherapy in relapsed/refractory AML/MDS, and of Hu5F9-G4 in combination with     azacitidine in previously untreated AML/MDS, as measured by the objective response rate.   "
2861|NCT03248466|"     To investigate the treatment effect between Traditional treatment and transplantation of     autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.   "
2862|NCT03248453|"     The aim is to investigate if feedback given by an automatic and objective system in simulated     colonoscopy (the investigation of the large intestine) increase learning and time spent     practicing.   "
2863|NCT03248440|"     This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5%     TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The     purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared     with placebo TDS in the treatment of a chalazion.   "
2864|NCT03248427|"     CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary     HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib     with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.   "
2865|NCT03248414|"     In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction     of fat mass assessed by DEXA compared to plaebo.   "
2866|NCT03248401|"     To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in     patients with type 2 diabetes mellitus   "
15093|NCT03087903|"     Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6     weeks for 3 months, then every 3 months thereafter for up to one year.   "
2896|NCT03248011|"     The purpose of the current study is, 1) Determine the effectiveness of injury prevention     programs for prevention of hamstring muscle strains, 2) Identify how these programs impact     athletes' flexibility, muscle stiffness, strength, and power, and 3) Determine the ability of     a state-of-the-art imaging technology, shear wave elastography to predict future hamstring     muscle strain injury.   "
2867|NCT03248388|"     This study is being done to determine if wearable text-to-speech (TTS) and visual pattern     recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow     patients to read and recognize faces and objects.      The Argus II retinal prosthesis can restore rudimentary forms of vision to patients with bare     light-perception vision. Using the prosthesis, patients can identify obstacles, handles,     switches, eating utensils and demonstrate improved navigation when used in conjunction with     other ambulation-assist tools. Current limits in the resolution of the device prevent useful     reading or face recognition. The FDA has approved the Argus II as a humanitarian device.      Present-day wearable text-to-speech converters are also capable of object and face     recognition. Such systems have been developed to assist with these tasks in patients with     severe low-vision. ORCAM is a commercially-available eyeglass-mounted visual pattern     recognition system capable of converting photographs of text to speech. It is comprised of a     camera, a small belt-worn computer, pattern recognition software and a small audio     transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user     through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize     faces and speak the name of the individual to the user. ORCAM can also be used to recognize     everyday products after being programmed.   "
2868|NCT03248375|"     The aim of this pilot study is to assess the efficacy of radiation segmentectomy with     Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for     thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due     to unfavorable location of target lesions.   "
2869|NCT03248362|"     This study aims to determine whether a programme of transcutaneous posterior tibial nerve     stimulation (TPTNS) is a clinically effective treatment for urinary incontinence (UI) in care     home residents and what the associated costs and consequences are.   "
2870|NCT03248349|"     Infections are common on the Intensive Care for both adult and pediatric patients. Adequately     dosing antibiotic treatment is of vital importance but both under- and overdosing is frequent     due to pathophysiological changes during critical illness. Moreover, the interplay of age and     critical illness is even more understudied.      To optimize antibiotic dosing and outcome of infectious disease, personalized dosing     guidelines in critically ill patients are highly needed. In this prospective observational     population pharmacokinetic study we will evaluate if target attainment for antibiotics is     reached in critically ill children with current dosing guidelines. Using these data,     individualized dosing guidelines will be developed.   "
2871|NCT03248336|"     This study is designed to evaluate changes in objective measures of disparity vergence after     office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in     children 12-17 years old.   "
2872|NCT03248323|"     Color coded blood flow and blood perfusion techniques are applied to the endovascular     treatment of infrapopliteal arterial occlusion,to establish a method of quantitative     evaluation of blood flow and tissue perfusion,to improve the level of calculation of     condition and curative effect. So as to establish a new complete evaluation system of     infrapopliteal arterial occlusive disease, to guide clinical further. At the same time     establish a digital information platform for clinical, lay the foundation for the large     research.   "
2873|NCT03248310|"     This study is being done to see the long-term results for patients who choose to have surgery     for lymphedema (with the vascularized lymph node transfer), compared to patients who choose     not to have surgery.   "
2874|NCT03248297|"     This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon,     Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 12 hours or     prolonged labor ≥ 24 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of     amoxicillin, compared to usual care (placebo). Women will be followed to ascertain maternal     infectious outcomes and perinatal outcomes.   "
2875|NCT03248284|"     Tendon pathologies (enthesitis) are a characteristic component of psoriatic arthritis (PsA),     and are observed in 35% to 50% of PsA patients. The Achilles tendon is one of the most     commonly affected sites. This condition often causes great morbidity and loss of quality of     life, and response only suboptimal to current intervention strategies. One of the main     obstacles for the development of effective treatment methods is that the disease mechanisms     remain poorly understood. To our knowledge, no one has yet ascertained the presence and     function of immune-competent cells and inflammatory markers in tendons tissue from PsA     patients suffering from Achilles enthesitis.   "
2876|NCT03248271|"     In this study investigator's aim to determine the impact of insulin therapy on hypotension     and sarcopenia   "
2877|NCT03248258|"     Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).      Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions     will be used to identify factors that influence decision-making in treatment selection and     the optimal approach for sharing information about prognosis and guideline-based care.     Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct     semi-structured interviews/discussion groups with patients, navigators, nurses, and     physicians to elements important to decision-making.      Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically     develop the TP intervention using the Ottawa Decision Support Framework. Investigators will     test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an     iterative process.   "
2883|NCT03248180|"     A 2-year prospective observational study comparing a group of patients in remitted states of     psychosis undergoing guided antipsychotic dose reduction to a similar group of patients under     maintenance antipsychotic treatment with the main outcome of interest that if the rates of     relapse of psychosis between these two groups will be different.   "
3418|NCT03241186|"     The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients     with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be     administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be     administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.   "
2892|NCT03248063|"     Methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia remains a major cause of     community- or hospital-acquired bloodstream infections with an overall mortality estimated     around 25%. Anti-staphylococcal penicillins (APs) such as oxacillin or cloxacillin are     recommended as first-line agents. With the exception of first-generation cephalosporin (1GC)     such as cefazolin, no alternative has yet proven a similar efficacy. Due to an unfavourable     safety profile for high doses used in severe infection, an uneasy dosing schedule in patients     with renal failure and possible recurrent stock-out events for APs, alternative to APs are     needed. This led to propose an open-label, randomized, controlled parallel groups, phase IV,     non-inferiority trial comparing the efficacy, the safety, and the ecological impact of     cefazolin versus cloxacillin for the treatment of MSSA bacteremia in adults.      The primary objective is to compare the therapeutic efficacy of cefazolin vs cloxacillin at     day 90 after the inclusion.    "
2878|NCT03248245|"     This study includes designing, implementing and evaluating the effectiveness of process-based     measures for improving interprofessional collaboration in Norwegian primary schools (5-7th     grades). Focusing on leadership and organizational development, the overarching aim is to     improve the use of existing interprofessional competence within schools. The interventions     include meetings at municipal-level (strategic), school-level (operative) and class-level     (operative), with feedback procedures to ensure communication between and within all levels.     Also school internal and school external collaborators are involved at all levels of     intervention.      In order to avoid contradictory roles, an implementation team is responsible for developing     and implementing the intervention, while the research team conduct an independent evaluation.     The model will be evaluated by a cluster-randomized design to evaluate the effectiveness of     the intervention. The hypothesis is that schools that utilize the process-based intervention     (intervention group) will improve their interprofessional team work in a way that enhances     the pupil's learning- environment and teachers professional competence, self-efficacy and     efficient use of working hours compared to their counterparts in the control group. We     anticipate main effects to be found at pupil level, mainly through improved early assessment,     intervention and efficient follow-up. The project is a collaboration between four Norwegian     municipalities and includes a total of 37 Schools, half of which will be randomized to     experimental condition and half to control condition.      The project is financed by The Norwegian Directorate for Education and Training with a     duration of three years and three months. The project is led by Professor Ira     Malmberg-Heimonen. The project is a collaboration between Faculty of Social Sciences and the     Work Research Institute (AFI), at Oslo and Akerhus University College of Applied Sciences.     Participants in the project are Ira Malmberg-Heimonen (project leader), Anne Grete Tøge,     Therese Saltkjel, Knut Fossestøl, Elin Borg and Selma Therese Lyng. Participants in the     implementation team are Øyvind Pålshaugen, Hanne Christoffersen and Christian Wittrock, also     from Oslo and Akerhus University College of Applied Sciences, in addition to Torbjørn Lund     from the Arctic University of Norway   "
2879|NCT03248232|"     Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical     outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high     surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI     compared to those in surgical aortic valve replacement, those in TAVI still remains high. In     addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus     aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach.     The antithrombotic regimen in patients undergoing TAVI is needed to be established.      To establish the antithrombotic regimen in patients undergoing TAVI,        1. the investigators assess the changes in platelet thrombus formation and white thrombus          formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis          System (T-TAS).        2. the investigators analyze plasma microRNAs, and shear stress by using computational          fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.   "
2880|NCT03248219|"     Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin     resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm     birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that     sleep disturbances are common during pregnancy, SDB remains under-recognized,     under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity.     Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB,     patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area     with major therapeutic implications to improve maternal and infant health. Using a     prospective design in which diet and gestational age are highly controlled, the investigators     propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep     monitoring system. In parallel, robust patterns of glycemia will be measured with a     continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to     measure insulin action. The investigators global hypothesis is that worse SDB in part     accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT)     pregnant women in their 3rd trimester. We will test the hypothesis that: 1) In obese NGT     pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher apnea hypopnea     index (AHI) will be positively associated with 24-hour glycemia measured by a CGMS and that,     2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a eucaloric controlled     diet will be associated with higher insulin resistance measured by a 75g oral glucose     tolerance test (Matsuda Model). Early identification and treatment has the potential to     decrease long-term maternal cardiovascular morbidity and mortality.   "
2881|NCT03248206|"     In this research work, the concept of strengthening technique of proprioceptive neuromuscular     facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve     neuromuscular function of upper extremity of patients with diabetes mellitus. The first     specific aim of the study is to examine the effects of home-based PNF exercise on the motor,     sensation and functional performance parameters of upper extremity of the patients with     diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the     home-based PNF exercises can provide better treatment effects for the patients with diabetes     mellitus will also been investigated in this study. One of the hypothesis of this study is     the prescribing home-based PNF exercise program has a positive treatment effect on     neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the     other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular     function of the upper extremity of patients with diabetes mellitus.   "
2882|NCT03248193|"     Paclitaxel is a chemotherapy drug that is used to treat breast cancer, one of the most common     cancers. It causes two side effects very often - hair-loss and numbness. Until recently,     there have been no known ways to prevent or treat either side effect. Recently, cooling of     the scalp to prevent hair loss caused by paclitaxel was approved. Our team is developing a     method to prevent numbness caused by paclitaxel by using a device that cools the arms and the     legs, while applying mild pressure, and this technique is called cryocompression. As scalp     cooling use in day-to-day cancer care increases, future studies involving cryocompression to     treat neuropathy must take this into account, lest patients be denied or are required to     trade-off one treatment for the other. However, there is concern of causing a reduction in     core body temperature, which would not be safe or a general intolerance to this treatment.     Both scalp cooling and limb cryocompression individually have not shown to cause this, but     simultaneous use has not been studied previously. Clinical safety studies, in healthy     subjects and cancer patients would need to be conducted to prove this theory, which is being     proposed by currently.   "
3419|NCT03241173|"     The purpose of this study is to determine the safety, tolerability, and efficacy of     INCAGN01949 when given in combination with immune therapies in participants with advanced or     metastatic malignancies.   "
2893|NCT03248050|"     Self-management of medical abortion (MA) pills purchased from pharmacies is considered to be     one of the reasons behind falling morbidity and mortality from unsafe abortion in recent     years. While pharmacy workers commonly sell MA medications over the counter, they have     inadequate knowledge about how women should take the medications and their potential     complications, and do not offer adequate information and counselling to women buying the     drugs. This study aims to evaluate if a pharmacy-based intervention to promote use of a     support hotline (Marie Stopes Zambia (MSZ) call centre) among MA purchasers can increase use     of the call centre, and to assess whether correct MA use and acceptability of self-     administered MA is higher among MA users who contact the call centre than those who     self-administer MA without call centre support.   "
2884|NCT03248167|"     This project aims to determine whether cannabidiol (CBD), a compound derived from the     cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with     comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that     oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with     PTSD. To test this hypothesis, 50 otherwise healthy adult participants with moderate or     severe AUD and PTSD will be randomized to treatment with either CBD (400 mg daily) or     placebo, for a period of 6 weeks, such that both participants and study staff are blind to     treatment condition. Participants (each treated for 6 weeks) will be continuously recruited     over a study period of 14 months until 50 have completed. Baseline and weekly data will be     collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD     treatment leads to a greater improvement in these measures relative to placebo, and whether     reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects     will also participate in a task designed to quantify the psychological and physiological     links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving.     The task will be administered at baseline, before treatment, and following 6 weeks of     treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated     negative emotion between CBD and placebo groups will be compared. This study will be the     first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in     humans, and the first to examine the interaction between these treatment effects. Results     will serve as proof of concept and provide guidance for a future larger clinical trial.     Because CBD is a safe, readily available drug, such a trial would have an immense potential     to prevent death, medical illness, and psychological suffering associated with AUD and PTSD.     Further, because the brain circuits via which CBD acts to produce hypothesized effects are     relatively well-understood, results may substantially advance understanding of the     neurobiological basis of alcohol addiction.   "
2885|NCT03248154|"     The objective of the study is to analyze the different implications (such as graft loss and     conversion of indeterminate depth burns) of biofilm infections in burn patients.     Additionally, it also aims at comparing children's resistance to biofilm infection at wound     site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.   "
2886|NCT03248141|"     Study Design      A prospective observational, cross-sectional epidemiological study in U.S. site-based     clinical practice settings.      30 sites will enroll approximately 300 patients      Participating patients - or their caregiver in the case of patients under the age of 18 -     will be consented to participate.      Physicians complete a retrospective chart review on each enrolled patient.      Patients will complete a one-time study questionnaire.   "
2887|NCT03248128|"     The goal of asthma treatment is to achieve and maintain asthma control and to reduce the     future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most     effective anti- inflammatory treatment for all severities of persistent asthma. For children     >=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive     therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is     designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component)     compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old     currently uncontrolled on ICS. The study will be conducted over a total duration of     approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and     1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF     administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will     be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist     (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870     subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years     (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered     trademark of GlaxoSmithKline (GSK) group of companies.   "
2888|NCT03248115|"     There is little information on the dietary intake, absorption, metabolism and bioavailability     (degree to which a substance becomes available to the target tissues upon administration) of     polyphenols (natural substances present in a variety of foods) in human participants.      This study assessed the bioavailability in healthy participants of polyphenols from 2     supplements containing green tea and green coffee extracts.      Eleven participants were recruited and their habitual diet was assessed to estimate     polyphenol intake. After completing a 24-hour urine collection, participants were given six     green tea extract and three green coffee extract tablets, which they took daily for a period     of 8 weeks. No tablets were taken during the last 4 weeks of the study. Further 24-hour     urines were collected at 2, 4, 8 and 12 weeks.      Participants were required to attend HNR (medical laboratory) the day after each 24hour urine     collection. At these visits, they were asked to bring along their urine collections,     completed documents (urine collection sheet, checklist for tablet intake/side effects) and     any remaining supplements, which were used to assess tablet compliance.      The investigators identified and quantified the amount of polyphenols in the supplement     tablets as well as the amount of polyphenols and their metabolites in urine. The     investigators then evaluated polyphenol bioavailability from the relationship between their     dietary intake and urinary output.      Evidence from this research could inform future intervention studies by providing data on the     bioavailability of green tea and coffee polyphenols, and on the individual differences     related to phenolic intake.   "
2911|NCT03247816|"     The aim of the study is to understand the early experiences of Feraccru® in patients with     inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including     treatment effectiveness, patterns of use and tolerability. By describing the characteristics     of patients treated with Feraccru® and their outcomes, this study will provide the medical     community with important information to support treatment decisions for their patients. This     will ultimately support improvements to patient care, including the long-term outcomes of     patients with IBD and IDA   "
3108|NCT03245242|"     The purpose of this research study is to evaluate an Enhanced Recovery After Surgery (ERAS)     protocol in children and young adults undergoing urologic reconstructive surgery. The     investigators plan to collect data on speed of recovery (how quickly pain improves, length of     time in the hospital, and the need for additional pain control) on patients who receive care     under the ERAS protocol and compare it to historical controls.   "
2889|NCT03248102|"     Acute appendicitis is the most common surgical emergency in childhood. Despite access to     current diagnostic modalities, diagnosis may be challenging since the child may have     difficulty in articulating symptoms. Additionally there is a high frequency of atypical     presentation and rapid progression. Delayed diagnosis in children is reported as being up to     60%. Delayed diagnosis >48hr increases the perforation rate from 21% to 71%. Around 20% of     children presenting with appendicitis have perforated by the time they come to surgery.      Appendix perforation is associated with a prolonged hospital stay and increased cost. Once     perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases     from 2 to 6 days and hospitalisation costs are estimated at US $33,348.      Conversely, a false positive diagnosis leads to unnecessary surgery in 12%. It has been     suggested that only 35% of surgical referrals with possible appendicitis actually need     surgery thus impacting on resource use.      A reliable test, especially if painless, would be very useful. If positive the child could     undergo early appendicectomy in expectation of a reduction in the perforation rate (and,     therefore, reduction in hospital stay). If negative the child could be discharged home     safely. No adequate biomarker has been identified.      Technology already exists to detect changes in Volatile Organic Compounds (VOC) in gases. VOC     analysis is already used commercially to identify disease processes in animals and crops.     Although VOC has been previously used to detect human diseases, it has never been used to     look for changes in the composition of breath in appendicitis.      The investigators hypothesise that the composition of VOC's in children with appendicitis     will differ from those without. The investigators anticipate these differences will be of     diagnostic and prognostic value in clinical practice. The feasibility of collecting breath     samples from children with possible appendicitis to allow VOC testing has not been examined.   "
2890|NCT03248089|"     Tumor Derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype     information about lung cancer, but its concordance with concurrent tumor-derived sequenced     data is not known. The primary objective of this study is to demonstrate the non-inferiority     of cfDNA-based versus tumor tissue-based genotyping.   "
2894|NCT03248037|"     Cornea transplant recipients who are using topical corticosteroids long-term to prevent     transplant rejection will be randomized to use netarsudil or placebo.   "
2897|NCT03247998|"     After a stroke caused by a blockage (clot) in a blood vessel in the brain, patients may have     the clot removed by threading a catheter from the groin up to the affected area of the brain.     An anesthesiologist is involved in the patient's care during this procedure to maximize     patient safety and procedural efficiency. The options for anesthesia for this procedure are     general anesthesia (where the patient is unconscious) or sedation (where the patient is in a     relaxed, calm, sleepy condition). Currently, it is unclear which of these anesthetic options     contributes to the best patient outcome. The investigators would like to investigate whether     or not one method of anesthesia (general or sedation) is better to use than the other when     removing the clot.   "
2898|NCT03247985|"     Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia     repair makes any difference in short-term pain or return to normal activities following the     operation. Other studies have shown no significant difference in hernia recurrence rate when     metal tacks are not used to hold the mesh in place.   "
2899|NCT03247972|"     Monoclonal antibodies against PCSK9 are innovative agents that provide very potent LDL     reduction when administered on top of statins. PCSK9 antibodies prevent LDL receptor     degradation and enhance circulatory LDL cholesterol clearance. High LDL is a major risk     factor for PAD and therefore lipid-lowering therapy constitutes another important therapeutic     intervention for patients with PAD. Evolocumab is a common PCSK-9 inhibitor that has been     shown to reduce plasma LDL.      In this study sixty subjects will be treated with high dose statins for 8 weeks followed by 8     weeks of high dose statin + evolocumab (420mg/4 wk) therapy. The laboratory assessments will     be performed at the screening (baseline), after 8 weeks of high-dose statin therapy, and 24     hr and 8 weeks after high dose statin + evolocumab therapy   "
2900|NCT03247959|"     The Purpose of this study is to evaluate the effectiveness of active ( video game) and     passive (video) distraction techniques on reducing fear and anxiety and improving oral health     knowledge of children undergoing extraction in the dental operatory   "
2901|NCT03247946|"     Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity     during the following year?   "
2903|NCT03247920|"     Randomized controlled open-label non-inferiority trial comparing complete intravenous     antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28     days) with probable bacterial infection.      Primary outcome:      - Bacterial re-infection within 28 days after finishing of antibacterial therapy.      Secondary outcome(s):        -  Pharmacokinetic profile of oral amoxicillin/clavulanic acid        -  Quality of life        -  Cost-effectiveness        -  Alterations in gut microbiome   "
2904|NCT03247907|"     A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP.     This study will also measure how much humidification is required to treat subsequent upper     airway discomfort/dryness from mouth leak by utilizing different levels and types of     humidification.   "
2905|NCT03247894|"     Aim of the retrospective study was to evaluate the influence of the labour on the clinical     course of the parturients with MS in selected 6 month follow-up interval and to evaluate to     possible influence of the different anesthesia/analgesia types on the course of MS.   "
2907|NCT03247868|"     the aim of this study protocol is to describe, using a longitudinal study, a multimodal     approach of treatment of cervical dystonia with botulinum toxin (BoNTA) and a new     rehabilitation protocol named SPRInt (Sensory-motor perceptive rehabilitation integrated)     approach based on motor learning techniques and spatial rehabilitation.   "
2908|NCT03247855|"     the aim of this study is to evaluate safety and efficacy of multivessel minimally invasive     coronary artery bypass graft surgery through evaluating the possibility of reaching complete     revascularization , the complications during surgery and the outcomes   "
2909|NCT03247842|"     Sixty patients with shoulder dystocia after breast surgery will receive either stellate     ganglion neurolysis with or without supra-scapular nerve radiofrequency,   "
2910|NCT03247829|"     This observational post market study is intended to characterize hemodynamic-guided     management of patients with an existing left ventricular assist device (LVAD) to protocol     specified target ranges and its impact on functional status, quality of life, and     readmissions   "
2960|NCT03247179|"     This project is a preliminary randomized controlled trial testing the potential impact of the     PTSD Coach mobile application at reducing posttraumatic stress and pain symptoms among     acutely injured trauma patients. Immediately following the injury, patients will be randomly     assigned to use the PTSD Coach app, or to the treatment as usual condition.   "
3015|NCT03246451|"     Delineation of the role of glucagon-like peptide-1 receptor signalling in the     glucose-lowering effect of metformin during meal ingestion in patients with type 2 diabetes.   "
2912|NCT03247803|"     The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be     used for primary airway maintenance or as a conduit for FOI, as can be the Williams,     Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall     geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a     traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that     dynamically adjusts according to the relative resistances to airflow between the patient's     lungs and the device's cuff. The purpose of this study is to compare the single-operator     intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for     flexible bronchoscopic intubation (FBI) and to compare the single-operator intubation success     using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible     bronchoscopic intubation. Both devices are commercially-available and being used in the study     in accordance with their labeled intended use. The investigator envisage that the endpoint of     the study will be single operator intubation success rate.   "
2913|NCT03247790|"     The purpose of this study is to measure how much of the drug gets into the blood stream and     how long it takes the body to get rid of it during an acute migraine attack and also during     the time between acute migraine attacks.      Information about any side effects that may occur will also be collected.      This study includes two study periods. Each study period requires an overnight stay in the     Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up     to two outpatient appointments. This study will last approximately 5-6 weeks (not including     screening).      Follow-up is required four to seven days after last dose of investigational drug. Screening     is required within 28 days prior to the start of the study.      This study is for research purposes only and is not intended to treat any medical condition.   "
2914|NCT03247777|"     Amateur female golfers were randomized to either a functional weight lifting group or a     traditional weight lift group. Testing, consisting of performance measures and golf measures,     was performed at baseline and after 10 weeks of weight lifting.   "
2915|NCT03247764|"     The prevalence of comorbid depression in patients with epilepsy is as high as 30-50%. The     depressive symptoms severely affect seizure severity and quality of life in patients with     epilepsy. The aim of this study is to register the diagnosis and treatment for depression in     patients with epilepsy from the East China, determining the incidence rate of comorbid     depression in patients with epilepsy and the choices for the antidepressant treatment. At the     same time, neuroimaging data such as brain MRI and blood sample will be collected to analyze     some biomarkers for the comorbidity of epilepsy and depression.   "
2916|NCT03247751|"     To evaluate rotational stability of the investigational device implanted after cataract     surgery.   "
2917|NCT03247738|"     In STEMI patients undergoing PPCI there is a delayed onset of action of oral P2Y12 receptor     inhibitors, including prasugrel and ticagrelor. Crushing prasugrel and ticagrelor improves     their PK and PD profiles as it favors drug absorption and onset of antiplatelet effects and     because of this, it is commonly used in STEMI patients undergoing PPCI. However, despite the     use of crushed tablets, up to one-third of patients may still have high on-treatment platelet     reactivity (HPR) within the first 2 hours after loading dose (LD) administration of these     oral agents. Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and     offset of action associated with a greater reduction in ischemic events compared with     clopidogrel in P2Y12 receptor naïve patients undergoing PCI. To date most studies have     explored cangrelor in the setting of PCI subjects treated with clopidogrel. The PD effects of     cangrelor in STEMI patients undergoing PPCI treated with a newer generation P2Y12 receptor     inhibitor and how this compares with a crushed formulation of the oral drug is unexplored.     The aim of this prospective randomized study is to investigate the PD effects of cangrelor in     STEMI patients undergoing PPCI treated with crushed ticagrelor.   "
2918|NCT03247725|"     The present investigation aims at exploring the effect of including a pain app called Pain     Monitor for chronic pain patients' daily monitoring. Three conditions will be set:        1. usual treatment (waiting list)        2. usual treatment + app (without alarms)        3. usual treatment + app (with alarms)   "
2919|NCT03247712|"     The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe     means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical     resection.   "
2920|NCT03247699|"     Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.      Treatment in period A is the Basel phenotyping cocktail capsule. Treatment in period B     consists of simultaneous intake of isolated formulations. In both study arms peripheral     venous and capillary blood (DBS) samples will be drawn   "
2921|NCT03247686|"     The present study will examine the role of circulating RNA complexed with autoantibodies and     immune complexes and its role in activation of inflammatory pathways in patients with primary     Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have     elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene     expression in blood cells. A number of biochemical and clinical parameters will be analyzed     to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.   "
2922|NCT03247673|"     This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose     Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product     CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg     of each product to healthy male subjects   "
2961|NCT03247166|"     The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The     system is designed to afford motion of the spine segment without fusion. The pur0pose of this     prospective clinical study is to establish the safety and effectiveness of the TOPS™ System,     when used following decompression, in the treatment of lower back and sciatic pain.   "
2962|NCT03247153|"     This study will examine the effect of corticosteroid treatment on heart function.   "
3031|NCT03246243|"     The main goal of this study is to quantitatively assess the sucking and feeding activity of     infants at high risk of neurological impairment (preterm infants and term infants with     hypoxic ischemic injury) during oral sucking and feeding and correlate it with their     underlying neurological impairment for the early diagnosis of brain injury.   "
3109|NCT03245229|"     The primary purpose of this study is to investigate the effect of ACT-132577 at steady state     on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects   "
2923|NCT03247660|"     Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and     treatment of postpartum pelvic floor dysfunction caused by vaginal delivery. Design:     Randomized, controlled and single blinded clinical trial. Participants will be randomly     assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus     hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive     exercises plus training in lifestyle advice; Control group: just training in lifestyle     advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before     intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3,     6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery),     primiparous, whose vaginal delivery has occurred in the PrÍncipe de Asturias Hospital,     which have not been already treated for pelvic floor dysfunction, and after reading,     understanding and freely signing an informed consent form. Sample size: 240 subjects will be     included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that     17% of women in the intervention group may develop pelvic floor dysfunction (urinary     incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1     in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive     analysis will be done of all variables. A confidence level of 95% (p <0,05) will be     established for all the cases. Effectiveness will be evaluated by comparing between the two     groups of the change in outcome variables between visits.   "
2924|NCT03247647|"     This study aims to examine the efficacy of an enhanced alcohol intervention among individuals     who are mandated to complete an alcohol education activity as part of a university sanction.   "
2925|NCT03247634|"     A new, practical program, entitled Getting Ahead in a Just-Gettin'-By World, provides a novel     approach to addressing this previously intractable problem. During the progression through     the Getting Ahead program, individuals develop an understanding of the hidden rules of     economic class and have an opportunity to craft a hopeful future story based on the practical     concepts investigated in the modules. Getting Ahead has shown great success in various     organizations and communities in multiple sectors, including healthcare, but has not been     studied in the context of advancing cancer prevention and control.   "
2926|NCT03247621|"     In this protocol, the investigators propose a randomised controlled trail to explore the     effects of environmental factors and the use of technology on eating behaviours. The     investigators have planned two studies to investigate these effects, one on high school     students from Raffles Institution, and the other on the university population in the National     University of Singapore.   "
2927|NCT03247608|"     This is a single-center, pilot study that will evaluate the effectiveness of the AHA science     based CarePlans and the Ambio Health technology in improving the risk adjusted 30 day     readmissions rate, patient compliance, and biometrics. The study will also be used to assess     the feasibility of similar heart failure transition programs in the future.   "
2928|NCT03247595|"     This study compares a colonoscopy preparation composed of magnesium citrate capsules to a     preparation of polyethylene glycol solution. The hypothesis is that the magnesium citrate     capsules work as well and are better liked by patients due to the lack of taste.   "
2929|NCT03247582|"     In order to understand the risks and benefits of edoxaban use in a real-world clinical     setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional     study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with     NVAF.   "
2930|NCT03247569|"     In order to understand the risks and benefits of edoxaban use in a real-world clinical     setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional     study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause     mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.   "
2931|NCT03247556|"     This study will evaluate the efficacy and safety of high doses of SPN-812 ER in adolescents     (12-17 years old)   "
2932|NCT03247543|"     This study will evaluate the efficacy and safety of high doses of SPN 812 ER in children with     ADHD   "
2933|NCT03247530|"     This study will evaluate the efficacy and safety of low doses of SPN-812 ER in children 6-11     years of age diagnosed with ADHD.   "
2934|NCT03247517|"     This study will evaluate the efficacy and safety of low doses of SPN-812 ER in adolescents     12-17 years of age.   "
2935|NCT03247504|"     Cancer pain is undertreated despite a good access to opioids in France. Although many factors     are involved, the barriers related to the patient (and his family) are often reported .the     reluctance of the patient or the family to take the prescribed medication is linked to     misconceptions about the opioids , cultural barriers; or the lack of explanations provided by     the physician. Some patients can have undiagnosed slight cognitive impairment .The situation     is now more complicated as appear on the market the new form of opioids for the cancer     breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of     the study is to measure the adherence to opioids in cancer out patients and the associated     factors.   "
2936|NCT03247491|"     The aim of this study is to assess a mindfulness and compassion group intervention for     pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of     stress, negative affect and depression in pregnancy and breastfeeding. This group     intervention will also be compared with a Treatment as usual (TAU) group consisting in a     childbirth education class taught by the Health Center midwife. The principal hypothesis is     that the mindfulness and compassion intervention will be more effective than TAU.   "
2937|NCT03247478|"     This is a prospective, single-center, non-randomized, non-controlled observational study.   "
2963|NCT03247140|"     The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine     and JLP-1401 in Healthy Male Volunteers Volunteers   "
2964|NCT03247127|"     The study aimed to investigate the memory preservation and neurocognitive function protection     of hippocampal avoidance whole brain radiotherapy (HA-WBRT) among people who speak Mandarin     Chinese or Taiwanese.   "
2965|NCT03247114|"     The study will consist of five occasions with one week in between. BOLD signal intensity of     the hypothalamus will be measured using fMRI. Measurements will be done before and after     drinking 300 ml plain water (reference) or water to which different sweeteners will be added.   "
2938|NCT03247465|"     Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve     implantation (TAVI) has been developed since 2002, first to treat rejected patients from     conventional surgery, then to treat high surgical risk patients and nowadays probably     intermediate surgical risk patient. TAVI related complications are still recurrent and the     investigators are searching a way to decrease them.      One of them could be image fusion, since it may decrease radiation exposure and contrast     agent use. It may also improve valve placement position leading to decreased complications.      40 prospective and consecutive patients will be included. Participants will be divided into     two groups: the 20 first included will be control group, the 20 following patients will be     the fusion group. For control group TAVI procedure will be the usual one, for fusion group     the procedure will be the usual one with addition of computed tomography 3D images fusion     with fluoroscopy 2D images.      Main evaluation criteria will be radiation exposure, measured by dose area product (DAP).     Secondary evaluation criterion will be procedural as contrast agent volume used, procedure     duration, subjective usefulness of image fusion or procedure failure evaluated immediately     after procedure. The investigators will also evaluated procedure induced complications as de     novo pacemaker implantation, de novo left bundle branch, vascular complication, major     bleeding, acute kidney failure, significant aortic regurgitation. These complications     occurrence will be evaluated after 1 month follow up, during the usual following     consultation.   "
2939|NCT03247452|"     This is a single center randomized controlled trial to compare bowel cleansing for outpatient     colonoscopy in two groups of participants: one group will receive instructions of one-day     structured low fiber diet whilst the other group will receive three-day low fiber diet.      Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic     acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.   "
2940|NCT03247439|"     This study will evaluate whether Cartiva is an effective treatment for individuals with     osteoarthritis of the CMC joint in the hand compared to LRTI.   "
2941|NCT03247426|"     The aim of this study is to compare sleep quality, job satisfaction, quality of life,     occupational burnout levels among individuals who do or do not do exercise.   "
2942|NCT03247413|"     Chronic neck and back pain has become one of the leading causes of disability and loss of     productivity. For many patients with facet or sacroiliac joint mediated pain who have     responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the     joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe     procedure with minimal risk of adverse events. However, with any procedure involving damage     to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The     investigators will test the hypothesis that dexamethasone injection delivered at the time of     lesion effectively prevents the development of post-ablation neuritis through a     placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic,     lumbar, and sacroiliac joint radiofrequency denervations   "
2943|NCT03247400|"     The aim of this study is to evaluate the influence of simvastatin and atorvastatin on     vitiligous lesions in patients with non-segmental vitiligo.   "
2944|NCT03247387|"     Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while     wearable devices can offer immensely more information that can improve the understanding of     this disease. With recent advancements in technology, investigators are now able to use     watch-like devices to more effectively measure the symptoms of Parkinson's Disease outside of     the doctor's office. The present study is designed to evaluate the usability, applicability,     and interpretability of an electronic VA Patient Motor Diary (eON-OFF), MC10 BioStampRC     actigraphy sensor, APDM actigraphy sensor and the GENEActiv Watch in persons with Parkinson's     Disease. There is no placebo/control group.   "
2945|NCT03247374|"     The primary purpose of the study is to evaluate whether the effect of bio-feedback dysphagia     treatment is more effective than a control treatment in post-stroke patients.      This study will be a randomized, single-blind controlled pilot study. The investigators     intend to recruit 40 patients who have suffered a stroke and have dysphagia. Twenty patients     will undergo training with bio-feedback (experimental group) and the other 20 patients will     undergo standard training, using only verbal feedback rather than visual feedback (control     group).      The authors hypothesize that in the control group the efficacy of the treatment will be lower     in the absence of immediate visual feedback of strength and coordination of the swallowing     act.   "
2946|NCT03247361|"     It is well-known that muscle weakness and deconditioning play an important role in low     exercise capacity of patients with HF. Interestingly, not only peripheral muscles are     impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in     addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and     structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of     inspiratory muscles have been associated with low quality of life and poor prognosis, which     make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular     rehabilitation.The specifications of the loads to be imposed during IMT is the main factor     determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory     workload during exercise. Thus, purpose of this report was to perform a randomized clinical     trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic     and resistance Exercise in patients with heart failure.   "
2947|NCT03247348|"     This study evaluates the feasibility of a behavioral intervention designed to replace     sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will     also evaluate the acceptability of the intervention among veterans and intervention effects     on pain and physical function.   "
2948|NCT03247335|"     Follow-up of Arthrosurface HemiCAP shoulder implants.   "
2985|NCT03246854|"     The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability     and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR     mutated lung cancer.   "
3106|NCT03245268|"     The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective,     multi-center, long-term observational project. Scheduled to start data collection in Q4 2017,     the registry will run for approximately four years with a follow-up time for each patient of     at least two years. Its primary objective is to investigate the efficacy and safety of BPA     intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not     amenable to pulmonary endarterectomy (PEA).   "
2949|NCT03247322|"     TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial,     involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness     of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve     medication safety and health outcomes, as compared to usual post-transplant care. The primary     goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues     leading to reduced healthcare resource utilization in kidney transplantation through a     pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel     information on the incidence, etiologies and outcomes of med errors and adverse drug events     in this high-risk population; while also demonstrating the effectiveness of this intervention     on reducing the incidence and impact of med safety issues in kidney transplantation.   "
2950|NCT03247309|"     This clinical research study investigates IMA201 which is composed of special immune cells (T     cells, also called T lymphocytes) being genetically modified by introduction of a     tumor-antigen specific T cell receptor (TCR) to fight against cancer. Patients that choose to     take part in this study have advanced cancer where there is no (further) standard treatment     for their cancer available OR current treatments are not tolerated.      The main purpose of this clinical research study is to confirm the safety of IMA201 and to     define the highest safe dose of IMA201 cells to give to patients. The study will also     investigate what the specific side effects of this treatment are, and to see whether this     therapy shows clinical activity in patients with their advanced cancer.   "
2951|NCT03247296|"     To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.   "
2952|NCT03247283|"     Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males   "
2953|NCT03247270|"     According to the Global Burden of Disease report in 2015, anxiety disorders are among the top     10 contributors to years lived with disability worldwide. There is a need for effective     treatment protocols. As cardiovascular fitness has a major impact on the brain's ability to     change structurally and functionally, interventions involving physical exercise might prove     positive in the treatment of persons with anxiety. Yet there are few high quality clinical     studies with physical exercise as an intervention for anxiety disorders.      Aims:        1. To test a 12 week physical exercise intervention for persons treated for anxiety          disorders within primary care. The exposure of interest is intensity of physical          exercise; outcomes include anxiety symptom burden, cognitive ability and sick leave.        2. To gain knowledge regarding potential mechanisms by comparing serum levels of specific          hormones and cytokines (characterized and associated with brain plasticity in animal          models) before and after different intensities of exercise.      Implementation:      Patients will be randomized into 3 groups: 1) Intervention I: 12 week exercise program with     low-intensity fitness training 3 times per week. 2) Intervention II: 12 week exercise program     with moderate to high-intensity fitness training 3 times per week. 3) Control group, who will     have a physiotherapy session once and will be given general advice about physical activity.     At baseline, 12 weeks and 1 year data of cardiovascular fitness, anxiety symptoms, cognitive     and working ability and biomarkers will be collected.      Impact:      If physical exercise positively affects anxiety disorders it would have significance, for the     patients as well as for society. In addition to increased quality of life, it may decrease     future marginalization and premature death among individuals suffering from anxiety     disorders. Reducing medical and sick-leave costs would also liberate health care resources to     be used elsewhere in an economically strained health care system.   "
2954|NCT03247257|"     This study is a prospective, comparative, controlled, blinded study that will enroll a total     of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder     removal. The objective of this study is to compare Epidural versus General Anesthesia for     postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy     patients.   "
2955|NCT03247244|"     For many individuals with Tourette syndrome (TS), available medications do not help with     their symptoms, or cause significant side effects. Two small controlled trials have     investigated the effect of oral delta-9-tetrahydrocannabinol (THC), a principal psychoactive     ingredient of cannabis, in TS patients. While these trials have shown promising results, the     effect sizes were not as large and consistent as those reported by patients with regards to     inhaled cannabis (smoked or vaporized). Indeed, based on anecdotal evidence, patients have     much greater improvement in their symptoms using inhaled cannabis than using cannabinoid     pharmaceuticals. However, there have been no controlled trials of inhaled medical cannabis     for TS to date. Furthermore, various medical cannabis products are authorized in Canada with     different contents of THC and cannabidiol (CBD), another primary cannabinoid. No data exists     regarding the dosing, efficacy and safety of these products in the treatment of TS. To gather     such data, a double-blind, randomized, crossover pilot trial will be conducted to compare the     efficacy and safety of three vaporized medical cannabis products with different THC and CBD     contents, as well as placebo, in adults with TS. As well, the PK/PD profile of THC and CBD of     the products will be assessed and correlated with tic symptoms   "
2956|NCT03247231|"     TO ANALYSE THE EFFICACY AND SAFETY OF ENDOSCOPIC BAND LIGATION WITHOUT RESECTION IN SMALL     GASTROINTESTINAL SUBMUCOSAL TUMORS   "
2957|NCT03247218|"     Symptomatic sickle cell disease (SCD) is worldwide the most frequent cause for hereditary     hemolytic anemia with recurrent pain crises. Hemolysis, vaso- occlusive and pain crises are     hallmarks of this disease and are causative for an important socio-economic burden worldwide,     especially in Africa.      Aside from allogenic stem cell transplantation, which is rarely available and very expensive,     at present there is no curative treatment for patients with SCD. The current standard of care     includes treatment with Hydroxyurea and symptomatic care such as transfusions,     antibiotic/analgesic treatment. Recent findings allowed the investigators to come up with a     novel pharmacological target for prophylactic treatment of this group of patients. The     investigators showed that N-methyl D-aspartate receptors (NMDARs) are substantially     up-regulated in circulating red blood cells (RBCs) of SCD patients. Ca2+ uptake via these     non-selective cation channels has major impact on RBC hydration and facilitates     polymerization of deoxygenated hemoglobin S variant in RBCs of patients. In vitro     observations shows that inhibition of NMDARs with Memantine caused re-hydration and largely     prevented hypoxia-induced sickling in RBCs. A pilot trial MemSID (NCT02615847) was conducted     in August 2015-March 2017 at the Hematology Division of University Hospital Zurich. A small     cohort of adult SCD patients was treated with 20 mg Memantine daily to test safety,     tolerability and efficacy of this drug and to assess the effect of Memantine on hemolytic     activity and RBC stability. Pilot data reveal safety and an impressive therapeutic potential     of Memantine in treating SCD patients. Due to a small number of SCD patients in Switzerland,     an extended trial including larger number of adult and adolescent patients will be performed     at the Pediatric Hematology Unit of the Emek Medical Center in Afula, Israel   "
2958|NCT03247205|"     This pilot study will look at whether it is possible to give better physical therapy to     people with cognitive limitations who have had a hip fracture.   "
2959|NCT03247192|"     The main purpose of the present study was to investigate the effects of whey protein     supplementation associated with resistance training on muscle strength, body composition,     muscle quality, cellular hydration, cardiometabolic risk factors, inflammatory and oxidative     stress markers in trained elderly women and to evaluate whether the timing of protein intake     provide different responses on these variables.   "
2966|NCT03247101|"     Morbid obesity has become a major global health problem, and the use of bariatric surgery is     increasing. One common complication seen following bariatric surgery is the formation of     gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder     and supersaturation of bile due to rapid weight loss and mobilization of cholesterol.     Previous studies revealed oral probiotics could reduce the cholesterol level by as much as     22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of     cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and     physiological actions of the end products of short chain fatty acid fermentation. Therefore,     the aim of this study was to determine the ability of probiotics to prevent gallstones     formation after bariatric surgery and to evaluate the impact of oral administration of     probiotics on the post bariatric surgery patients 's quality of life.      Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the     quality of life for patients receiving bariatric surgery. It consists of five domains:     digestive symptoms; physical function; emotional condition; social condition and effect of     medical treatment, which could access the quality of life of bariatric patient effectively     and completely.   "
2967|NCT03247088|"     The goal of this clinical research study is to find the highest tolerable dose of sorafenib     (out of 4 possible doses) that can be given in combination with busulfan and fludarabine     before an allogeneic stem cell transplant and alone after the transplant. Researchers also     want to learn if this combination can help to control acute myeloid leukemia (AML). The     safety of this drug combination will also be studied.   "
2968|NCT03247075|"     Social anxiety disorder among youth is highly prevalent and causes significant impairment in     the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective     treatment, research suggests that many young people with this disorder do not have access to     good-quality CBT. Internet-delivered CBT could be an effective method to increase     availability of evidence-based treatments for youth with social anxiety disorder. The primary     objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth     (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized     controlled trial with N = 101 participants. Participants will be randomized to either the     active treatment arm (guided ICBT) or to a control condition (guided internet-delivered     support and counseling). Follow-ups will be conducted at 3 and 12 months after     post-assessment.   "
2969|NCT03247062|"     Summary of the project :      Lack or disturbances of sleep are major problems in patients staying in intensive care unit     (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead     to progressive deafferentation. The patients are then at risk of immune deficiencies,     agitation and confusion states, cognitive troubles that may be associated to increased     morbidity and mortality in the short and long term. Thus, improvement of the sleep of the ICU     patients may impact non only during the ICU stay but also on their future quality of life.      The sleep bundle project is a quality improvement project with a before-after design,     consisting in the evaluation of a bundle of measures that may increase the quality and     duration of sleep in ICU patients.      The bundle consists in the proposition of eye-mask, ear-plugs, music and/or massage to the     patients in parallele to structural and organizational modifications of the service such as     the decrease of the alarms sounds, changing the luminosity between day and night, etc.      The principal indicators followed will be:        -  The sleep quality of the patients        -  The continuous noise intensity in the rooms        -  The continuous light intensity in the rooms Baseline - before period: 8 weeks          Implementation of the bundle with training of the team: 4 weeks After period: 8 weeks.   "
2970|NCT03247049|"     The clinical evidence shows that patients with a first episode of intracerebral hemorrhage     (ICH) are increasingly old and with greater comorbidity with a recognized impact over     mortality. The prediction of the outcome of ICH is not only crucial in the emergin attention     to identify those patients with favorable criteria that can benefit from possible treatments;     but also after hospital discharge, in primary care where the prediction should facilitate the     organization and management of a wide variety of resources: familiar, health and social     welfare. Even though there are different scales that predict mortality, these are not     sufficiently useful in choosing a treatment or do not provide sufficient data to the family     to decide.      Due to the characteristics of the population with ICH described in these works, it seems     useful to propose a prognostic index (ICHCat) to identify the variables associated to its     incidence and mortality and that, in addition, to make adjustments in the comparisons of the     survival between different series of patients or different treatment modalities in primary     care.   "
2971|NCT03247036|"     A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but     there are gender differences. The authors sought to examine the relationship between sex and     outcome after thrombolysis.      Previous reports [1-6] concerning sex-related differences in stroke management and outcome     are inconsistent and sometimes difficult to interpret, and so the reasons for gender     disparities in stroke outcome have remained unclear. Functional outcomes and quality of life     after stroke are consistently poorer in women despite adjustment for baseline differences in     age and prestroke function, and the fact that comorbidities and clinical outcomes were not     different between women and men [3, 7] . Once the reasons for these differences are better     understood, intervention might be possible to help provide the best care for all patients.     This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has     suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11]     .The authors will explore whether sex might modify the effect of thrombolysis on survival and     functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated     time period of 6 months after stroke and compared this with the group without thrombolytic     treatment.   "
2972|NCT03247023|"     This study will evaluate the long term performance and safety data for the Cadence™ Total     Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis     (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if     minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g.     rheumatoid arthritis, hemochromatosis)   "
3608|NCT03238703|"     This pilot clinical trial studies how well endocrine therapy works in treating patients with     HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells.     Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators     may lessen the amount of estrogen made by the body.   "
2973|NCT03247010|"     Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant     prostate cancer and bone metastases. Therapy is administered intravenously every 4 weeks for     up to 6 cycles. More than 20 % of patients treated at Rigshospitalet develop bone marrow     suppression as a side effect to Radium therapy, which delays or excludes the patient from     further oncological therapy. Especially thrombocytopenia is a frequent side-effect and can be     long lasting.      The aim of the study is to examine whether biomarkers of bone marrow recovery (immature     platelets, platelet volume, reticulocytes, red cell distribution width) can predict     development of hematological toxicity during Radium therapy. Furthermore, to investigate     whether these biomarkers can predict recovery from toxicity in patients who develop bone     marrow suppression during therapy.   "
2974|NCT03246997|"     Project Powerfood is a pilot program aimed at addressing food insecurity and food access in     primary care through the implementation of a food prescription program in collaboration with     a number of community partners. The objectives of this project are:        1. Implement screening for food insecurity in adult and pediatric primary care practices at          Mount Sinai.        2. Provide fresh fruit and vegetable prescriptions to be redeemed for farm shares from          local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a          fruit and vegetable box. Participants will have the option to purchase 2 boxes per month          for 6 months.        3. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese          children who are food insecure and/or receive SNAP and/or WIC benefits.          Examine/evaluate:             1. Feasibility of program in a busy primary care practice             2. Outcomes before and after the intervention (at baseline, 6 and 12 months),               including diet, diabetes control, and body mass index (BMI)             3. Outcomes in a comparison group (that will receive the food prescriptions beginning               at 6 months)   "
2975|NCT03246984|"     This is a prospective single arm study enrolling patients who are scheduled for creation of a     new Brachiocephalic AV fistula. Up to 50 patients will be enrolled. All patients will be     implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular     access. The follow up period in this study will be for a duration of 12 months, with follow     up visits scheduled at 1, 3, 6, 9, and 12 months.   "
2976|NCT03246971|"     This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy pain     over a 24 hours period. Two out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects     will receive placebo.   "
2977|NCT03246958|"     This research study is studying nivolumab, an investigational drug, in combination with     ipilimumab, also an investigational drug, as a possible treatment for thyroid cancer.      The drugs involved in this study are:        -  Nivolumab (Opdivo™)        -  Ipilimumab (Yervoy™)   "
2978|NCT03246945|"     Advances in smart phone-based photography (both quality and image transmission) offer the     potential to greatly improve access to pediatric dermatologists. However, the accuracy of     diagnoses reliant on parent-provided photographs has been neither measured nor compared to     diagnoses based on in-person examinations. Therefore, the primary objective of this study was     to assess the concordance between diagnoses based on photographs taken by parents (or legal     guardians) and those based on in-person examinations. A secondary aim was to assess the     effect of photography instructions on improving this concordance.   "
2979|NCT03246932|"     Profession-led psycho-education programs for people with schizophrenia are evidenced to     improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless,     other benefits to patients, for example, their functioning and insight into illness or to be     substantive in a longer term (>12 months) are inconsistent and uncertain, especially in Asian     populations. This single-blind multi-site randomized clinical trial was to test the effects     of a peer-expert-led psycho-education group intervention (in addition to usual care) for     adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison     to a profession-led psycho-education group or treatment-as-usual only.   "
2980|NCT03246919|"     This study will evaluate if the timing of oxytocin administration in cesarean deliveries will     affect the amount of maternal blood loss. Half of participants will receive oxytocin after     delivery of the fetal anterior shoulder and the other half will receive oxytocin after     delivery of the placenta. We hypothesize that administering oxytocin after delivery of the     shoulder, will result in less overall maternal blood loss.   "
2981|NCT03246906|"     This randomized phase II trial includes a blood stem cell transplant from an unrelated donor     to treat blood cancer. The treatment also includes chemotherapy drugs, but in lower doses     than conventional (standard) stem cell transplants. The researchers will compare two     different drug combinations used to reduce the risk of a common but serious complication     called graft versus host disease (GVHD) following the transplant. Two drugs, cyclosporine     (CSP) and sirolimus (SIR), will be combined with either mycophenolate mofetil (MMF) or     post-transplant cyclophosphamide (PTCy). This part of the transplant procedure is the main     research focus of the study.   "
2982|NCT03246893|"     Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them     required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as     an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen     nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory     failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and     high risk for reintubated patients. There was no information about HFNC versus NIV in     prevention of reintubation among severe sepsis or septic shock patients.   "
2983|NCT03246880|"     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III     Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia     Patients.   "
2984|NCT03246867|"     The purpose of this study is to investigate and compare the acute effects of isolytic and     static stretching training in individuals having subacromial impingement syndrome with     glenohumeral internal rotation deficit. Isolytic group will receive isolytic stretching in     modified cross body position. Static group will receive static stretching in modified cross     body position. Stretching groups will be evaluated before and just after stretching exercise.     Control group will receive no stretching. Control group will be evaluated for the first time     and then will be waited until the duration of the stretching exercise program. Afterwards,     second evaluation will be performed   "
2986|NCT03246841|"     TUMOSPEC is a national family study designed to measure the relative and absolute risk of     cancer for carriers of deleterious mutations to these new breast cancer (BC) susceptibility     genes. Index cases will be enrolled consecutively from patients attending an appointment at     one of the Unicancer centres, with no other inclusion criteria, and offered a BRCA1/2     analysis as part of their care plan. A panel of 24 TUMOSPEC genes, chosen in advance by a     steering committee, will be tested as the same time as the BRCA1/2 genes, at one of the usual     BRCA1/2 analysis laboratories belonging to the same network and participating in the study.     If a mutation is found, the index cases will be asked to invite their first and second degree     family members and their cousins to take part in the study, regardless of whether they have     cancer. Saliva samples will be then taken and used for a targeted analysis of the familial     abnormality. Each participant will also complete an epidemiological questionnaire in order to     gather information about his/her medical history and any exposure to various risk factors.     All medical and genotype data will be centralised at the Genetic Epidemiology Research     Platform (PIGE, INSERM). The cumulative mutation frequency for all genes is estimated at 10%.     Penetrance will be analysed using methods designed to minimise selection bias. The expression     spectrum of the mutations will also be described. For genes where the number of mutated     families is too low, the data may be contributed to international consortia. The main project     will be preceded by a two-year feasibility study, using the same inclusion criteria and     logistic circuits. It is this pilot study to which the current funding application relates.   "
2987|NCT03246828|"     The aim of this study is to determine whether fasting and post-prandial glucagon secretion is     suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an     oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for     3 days.   "
2988|NCT03246815|"     National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for     sexually active young women under the age of 25. Despite these recommendations, many young     women are not being screened for STDs, with some estimates that less than 50% of women     receiving health care are screened for chlamydia. Untreated STDs can lead to important     sequelae to women's reproductive health including pelvic inflammatory disease, infertility     and ectopic pregnancy. One of the most important barriers to widespread STD screening is     provider failure to recognize an opportunity for STD screening. The goal of this study is to     determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member     of the medical practice (who receives an automated alert indicating STD screening should be     offered) will be associated with a higher rate of STD screening in young women attending     primary care practices compared to usual care (where a physician offers screening with no     electronic alert). This study will be performed in UPMC-affiliated primary care practices     (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the     intervention or usual care. The intervention will be an auto-task in the electronic medical     record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer     chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out     manner, to eligible women. Practices assigned to the usual care group will not have the     intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be     compared between the to groups (intervention practices and control practices). Results of     this study may be important to guide national STD screening recommendations and will address     critical barriers to widespread STD screening.   "
2989|NCT03246802|"     A dose-response relationship for radiation in the management of prostate cancer is well     established. Local recurrence of prostate cancer after external beam radiotherapy occurs in     at least 40% of patients treated because of inability to deliver sufficient dose through     external beam techniques. These patients respond well to re-irradiation using brachytherapy     with about 50% of selected patients remaining free of recurrence 5 years after salvage.     Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows     identification of the site of recurrence, permitting partial prostate salvage brachytherapy.     There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose     Rate.   "
2990|NCT03246789|"     The purpose of this study is to test the feasibility of two types of group therapy sessions.     The research is being done because the researchers are trying to learn if these approaches     could be used by therapist in the community social service agencies to treat older adults     with depression. There are two study groups. One group is a form of group therapy called     Engage-M, which encourages subjects to engage in physical and social activities that they     find pleasurable or rewarding. One group is another form of group therapy called, Wellness     in Mind and Body, which focuses on education and de-stigmatization of health and mental     health conditions.   "
2991|NCT03246776|"     The clinical study of the microbial colonization of chronic keratinized hand eczema and the     change of microbial colonization after external using of Halometasone Triclosan Cream   "
2992|NCT03246763|"     Current obesity treatment guidelines recommend 26 or more hours of behavior treatment,     delivered over a 6-month period in a multidisciplinary weight management clinic. However,     this guideline is not feasible in real-world clinic settings where medical visits are costly     and poorly reimbursed, and attrition is high, particularly among the most vulnerable     children. The National Collaborative on Child Obesity Research has issued a call for research     investigating healthcare-community partnerships to improve the effectiveness of child obesity     treatment. The World Health Organization supports this approach, and in 2015 modified the     chronic disease model to include healthcare-community integration. Arches is a three-year     project that will develop and evaluate an effective, engaging, and scalable     community-healthcare treatment option for low-income and racially diverse children. The     project engages four communities in North Carolina and facilitates a local clinic-community     partnership, supports the development of an integrated childhood obesity treatment program,     and evaluates the feasibility of the integrated program model. The effectiveness of the     integrated model will also be evaluated, as we will monitor patient outcomes associated with     participation.   "
3027|NCT03246295|"     Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses.     At present, no prediction marker for GDM in early pregnancy is accepted. There is still a     lack of recognized early predictors. This study was designed to identity valuable biomarkers     for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in     early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral     glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed     according to the latest ADA standard. Urinary samples were collected in the first (<12     weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics     and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass     spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal     analysis; 15 cases of GDM women and 15 cases of age matched control women were used for     difference analysis.   "
14748|NCT03092427|"     This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the     activity of the disease in patients with Juvenile Idiopathic Arthritis.   "
2993|NCT03246750|"     Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/     dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell     Lymphoma      Phase: I/II      Number of Patients: 36      Study Objectives      Primary        -  To determine the safety and optimal dose of brentuximab vedotin when use in combination          with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed          ENKTL patients      Secondary        -  To evaluate the clinical efficacy of this regimen        -  To access the overall responses including overall response rate (ORR), disease-free          survival (DSF), progression-free survival (PFS).      Overview of Study Design:      Open-label, multicenter, non-randomized, 3+3 dose escalation study of brentuximab vedotin in     combination with fixed-dose MAD chemotherapy. The first cycle will be evaluated for the     determination of the recommended phase II dose.      Patients will be received the treatment according to the stage of disease as follows:        -  Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field          radiation (IRFT) with concomitant weekly intravenous Cisplatin. Three to five weeks          after the completion of IFRT and cisplatin, B-MAD (Brentuximab vedotin, Methotrexate,          L-asparaginase and Dexamethasone) regimen will be given every 21 days for 3 cycles.        -  Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for          6 cycles.      Study Population:      Patients with newly-diagnosed ENKTL will be screened for enrollment.      Duration of Study: 3 years   "
2994|NCT03246737|"     Multiple cardiovascular adaptations happen during pregnancy. When gestational hypertensive     disorders (GHD) occurs, these adaptations are abnormal. Approximately 5 - 8 % of all pregnant     women develop GHD.      GHD is an pregnancy complication which is characterized by an elevated blood pressure (≥     140/90 mm Hg) and sometimes the appearance of proteinuria (≥3 g/ 24 hours) after twenty weeks     of pregnancy. When this remains uncured, GHD can have severe complications for both mother     and child. For this reason, a close follow-up of women with a high risk for developing this     condition is recommended. This to detect and threat GHD early.      Patients can be included when they are at least 10 weeks pregnant. Every pregnant women     receives two devices to control daily here parameters in her home environment: a blood     pressure monitor and an activity tracker. The women will be asked to perform two blood     pressure measurements a day and to wear the activity tracker day and night. This data will be     send by Bluetooth and Wi-Fi to the investigator in the hospital. Also will the women be asked     to measure once a week her weight and send this to the hospital.      Name of the device Measurement Protocol Blood pressure monitor Blood pressure, heart rate     Twice a day (morning and evening) Activity tracker Activity- and sleep pattern Day and night     Weight scale (not remote) Weight Once a week (morning)      The investigator controls daily the incoming measurements and consults the responsible     gyneacologist when events (= abnormal blood pressure or weight measurement) occurs. Depending     on the decisions of the gyneacologist, following actions can be performed:        -  Further observations        -  Extra monitor        -  Adjustments to the medication scheme        -  Performing an 24 hours urine collection        -  Admission to the prenatal observation ward When results are missing, the investigator          contacts the women to ask of this measurement is due to personal or technical causes.      The purpose of this study part is to detect early signs of PE.      When patients gave birth, the data about the delivery (duration of labour, complications,     mode of delivery, date of delivery, complications, parameters of the mother, specialties) and     the neonate (gestational age, date and hour of birth, Apgar score, birth weight, length,     complications and admission to the neonatal intensive care) will be collected. These data     will be compared to the data of women who were admitted to the hospital for GHD, but who     doesn't receive remote monitoring devices.   "
2995|NCT03246724|"     The purpose of this study is to evaluate patient satisfaction after eye surgery when given a     capsule compared to an intravenous (IV) dose of sedation (calming medication).      Each subject will be given a capsule and an IV in the hospital before their procedure starts,     however they will not know which one is the sedation route. Each subject will have their     planned surgical procedure as previously discussed with their doctor. After the procedure is     completed, the doctors will complete satisfaction surveys. The subject will also complete a     satisfaction survey during their regularly scheduled visit the day after surgery. Once the     subject completes this survey, their study participation will be complete.      The hypothesis is that there will be no difference in patient satisfaction when given a     capsule in comparison to IV sedation. If the results of the study support this hypothesis, a     capsule could be used in place of IV sedation. By using a capsule for ocular procedures, both     patients and the medical practice would benefit: patient recovery time would decrease,     patient costs would be decreased, hospital costs would be reduced, and some of these     procedures would be given the option to move to a procedure room (freeing up operating room     time for other departments).   "
2996|NCT03246711|"     Prospective comparative cohort study including 159 pregnant women at the third trimester     recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during     the holy month of Ramadan (from 18th June To 16th July 2015).      The patients recorded their pattern of fasting during Ramadan then grouped into three groups     A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally     fasting group   "
2997|NCT03246698|"     The purpose of this study is to investigate and compare the effect of isolytic and static     stretching training in individuals having subacromial impingement syndrome with glenohumeral     internal rotation deficit. Isolytic group will receive isolytic stretching in modified cross     body stretching position and standard physiotherapy program. Static group will receive static     stretching in modified cross body stretching position and standard physiotherapy program.     Control group will receive only standard physiotherapy program.   "
2998|NCT03246685|"     Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in     subjects with advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Safety: To     characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis:     Restore (for subjects who have failed pembrolizumab mono therapy) or enhance (for subjects     who actively experiencing SD) sensitivity to checkpoint inhibitors (CPI) by appropriate and     effective stimulation of the subject's innate and adaptive immune systems by combining     Imprime PGG with pembrolizumab.      The study will require documenting at least 5 objective responses among the 38 subjects     enrolled who have failed prior pembrolizumab monotherapy and at least 17 objective responses     among the 49 subjects enrolled who are actively experiencing stable disease following at     least 4 cycles (but no more than 8 cycles) of pembrolizumab monotherapy.   "
2999|NCT03246672|"     Although bariatric surgery is highly effective for inducing significant weight loss and     resolution of comorbidities, weight regain following surgery is a common problem. This pilot     study will test the feasibility and acceptability of an intervention designed to help     bariatric surgery patients maintain weight loss. Findings from this pilot will provide the     foundation for a randomized controlled trial to evaluate the efficacy of the intervention.   "
3088|NCT03245502|"     Venoarterial CO2 difference, (delta CO2) lactate, pH will be recorded in several steps in     valvular and coronary artery bypass graft operations. The patients will be divided in two     groups as Transfusion and No Transfusion Groups observationally. The trend of delta CO2,     postoperative complications and 28 days mortality will be compared.   "
3000|NCT03246659|"     The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to     investigate the IMP, namely 111In-CP04.      The study consists of preclinical (to establish a clinically useful formulation for the     radiolabelled peptide CP04), and a clinical step. The main objective of the clinical part of     the project is to establish the safety of i.v. administration of a high peptide amount and to     assess the tracer biodistribution and dosimetry in MTC and normal tissues and to determine     critical organs as well as the evaluation of the potential of CCK2 receptor scintigraphy to     detect cancer lesions for both low (10ug) and high (50ug) peptide amount and the decrease of     kidney dose after co-administration of gelofusine /gelaspan as a nephroprotective agent. To     achieve this, the following study design has been accepted: the first 4 patients will receive     2 peptide amount of CP04: low peptide amount (for diagnostic purpose) and high peptide amount     (for therapeutic purpose) of CP04. If no SAE is present, the remaining pts will be randomized     for 2 arms: high peptide amount of 111In-CP04 with and without gelofusine/gelaspan infusion.      It is expected that CCK-2/gastrin receptor imaging will become a valid diagnostic method for     a specific non-invasive staging and follow-up of patients with MTC, and treatment of     recurrent and disseminated disease will be more efficient with minimized nephro- and     myelotoxicity (if 111In labelled).   "
3001|NCT03246646|"     This project will develop and pilot test an enhanced, telephone coaching intervention to     help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to     seek treatment for a substance abuse problem.   "
3002|NCT03246633|"     The aim of this study is to assess a novel educational mobile and online application which     will use images of pigmented skin lesions with question prompts to train future medical     providers to more accurately detect malignant lesions.      The hypothesis of this study is that this new educational tool will result in higher melanoma     detection rates among future providers.   "
3003|NCT03246620|"     The purpose of this study is to determine whether oral olanzapine is safer (fewer adverse     events) and more effective (shorter time to sedation) than conventional haloperidol or     diazepam when used in the management of acute agitation in the emergency.   "
3004|NCT03246607|"     This study evaluates the validity of an intravascular continuous glucose monitoring     microdialysis probe, and compares the values to routinely inserted cerebral glucose     microdialysis to evaluate the hypothesised relationship between intracranial and     intravascular glucose levels.   "
3005|NCT03246594|"     The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation     of atrial fibrillation regarding oesophageal ulcers after ablation.   "
3006|NCT03246581|"     The purpose of this study is to compare the absorption of a test inhalation product with the     reference product in healthy volunteers.   "
3007|NCT03246568|"     Atrial fibrillation (AF) is the most common arrhythmia and it is associated with significant     morbidity and mortality. Electrical isolation of the pulmonary vein (PVI) by radiofrequency     energy or cryoablation has been shown to be an effective treatment of AF by reducing     morbidity, improving quality of life and functional capacity.      Renal artery sympathetic denervation (RND) by catheter ablation has been shown in a     preliminary study to improve outcome of PVI in patients with paroxysmal and/or persistent AF     with concomitant refractory or moderate hypertension. In patients with renal impairment, RND     also conferred benefit in reducing AF recurrence after PVI. The initial indication for     catheter-based RND is for blood pressure control in patients with resistant hypertension.     However, a recent study failed to show significant difference in blood pressure reduction by     RND. Therefore, the effect of RND on AF suppression may be independent of blood pressure     control. Possible mechanisms of RND on AF may include risk factors modification and     anti-arrhythmic effect.   "
3008|NCT03246555|"     The objective of this study is to confirm the noninferiority of the blood pressure lowering     effect of fimasartan and evaluate its safety compared to perindopril in the elderly with     essential hypertension.   "
3009|NCT03246542|"     HELLP syndrome is a life-threatening obstetric complication usually considered to be a     variant or complication of pre-eclampsia. And may occasionally be confused with other     diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis,     hepatitis, appendicitis, gallbladder disease, immune thrombocytopenia, lupus flare,     antiphospholipid syndrome, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura,     and nonalcoholic fatty liver disease. The distinction between thrombotic thrombocytopenic     purpura-hemolytic uremic syndrome and severe preeclampsia is important for therapeutic and     prognostic reasons. However, the clinical and histological features are so similar that     establishing the correct diagnosis is often difficult; furthermore, these disorders may occur     concurrently.   "
3010|NCT03246529|"     A total of 207 subjects will be randomized into the study which will employ a double-blind     placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared     to G-CSF + placebo.   "
3011|NCT03246516|"     This study evaluates the role of socioeconomic and individual factors in the onset of the     first symptoms of cancer and the first consultation with a doctor (patient delay) in     oeso-gastric cancer.   "
3012|NCT03246490|"     This study aims to develop a phone app to assess gait differences at different levels of     alcohol intoxication.   "
3013|NCT03246477|"     Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates,     improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in     patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse     has been described in the target population, especially when associated with significant     weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The     surgeons of the Division of Maxillofacial Surgery already started to perform this type of     surgery in 1995.      Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery)     biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the     stability of hard and soft tissues and polysomnographic results.      Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography     and quality of life questionnaires will be retrieved from all patients that were surgically     treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999.      Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However,     long-term data are lacking. This retrospective study might provide us with more information     about the incidence of clinical relapse fifteen to twenty years after surgery.   "
3016|NCT03246438|"     This pilot study is a 3-arm randomized control trial assessing the effectiveness of     sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy     outreach only, in patients between 50-74 years old, who have received care at the University     City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and     are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control),     Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test)     (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active     Choice).   "
3017|NCT03246425|"     Mechanical ventilation has been known to produce changes in the flow of blood through the     major blood vessels in the body. These changes may go undetected, but with continuous     arterial blood pressure measurements, changes in the arterial waveform can be visualized.     Although we know that these arterial pressure variations occur during mechanical ventilation,     little is known about the effects of various modes of mechanical ventilation on these     changes. The most common modes of ventilation used in ICU are Volume control, Pressure     control and Airway pressure release ventilation.      Objective We have designed a prospective randomized pilot study to determine the effects of     the commonly used ventilator modes on the arterial pressure.   "
3018|NCT03246412|"     The study investigates if a computer-based clinical decision support tool for skin cancer may     improve the diagnostic accuracy of general practitioners (GPs). The aim of the program is to     help GPs increase their diagnostic accuracy, in particular regarding the selection of     suspicious skin lesions that need biopsy or referral to specialist health care for further     assessment. Half of the physicians in the trial will have the clinical decision support tool     available during consultations, while the other half has no such tool available. We     hypothesize that general practitioners using the clinical decision support tool will have a     higher number of correct classifications of skin lesions compared to doctors without the     tool.   "
3019|NCT03246399|"     SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension     will be administered via a single intradiscal injection to subjects with degenerative disc     disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in     successive cohorts. Subjects will participate in a 6 month follow-up period. Clinic visits     will be Screening, Treatment Visit Day 1, and Follow-up Visit Days 2, 15, 28, 60, 90, 135,     and 180.   "
3020|NCT03246386|"     Although posaconazole is approved for the prophylaxes and treatment of invasive fungal     infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not     specified. There is clear evidence indicating that heavier patients are receiving a     sub-optimal dose if the current guidelines are used. Specifically in the setting of augmented     prevalence of species with intermediate susceptible to posaconazole, adequate dosing is     needed at start of treatment.      Therefore it seems prudent to conduct a trial in a cohort of obese patients who receive     posaconazole (300mg or 400mg) and define the pharmacokinetics. These will then be compared to     the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.   "
3021|NCT03246373|"     This study observed the relationship between cerebral collateral circulation and the     prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and     leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The     participants' clinical performance caused by leukoaraiosis will be assessed by a series of     scales.   "
3022|NCT03246360|"     Our objective is to establish pharmacological equivalence of intermittent and continuous     infusion of cloxacillin during methicillin-susceptible Staphylococcus aureus (MSSA) bone and     joint infections (BJI). Twelve patients suffering MSSA BJI will receive both administration     modalities and serum concentrations of cloxacillin will be determined after 3 days of II and     3 days of continuous infusion in a prospective, randomized, open-label, monocentric crossover     study design.   "
3023|NCT03246347|"     This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with     the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer.     The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated     and demonstrates improved efficacy compared to ADT + docetaxel.   "
3024|NCT03246334|"     Due to advances in critical care medicine, more patients survive their critical illness.     However, intensive care unit (ICU) survivors often experience long-term physical, cognitive     and mental problems, summarized as post intensive care syndrome (PICS), impacting their     health related quality of life (HRQoL). In what frequency PICS occurs, and to what extent     this influences ICU survivors' HRQoL, is mostly unknown.      The aims of this study are therefore to study the: 1) five-year patient outcomes, 2)     predictors for PICS, 3) ratio between HRQoL of ICU-survivors and healthcare related costs,     and 4) care and support needs.   "
3025|NCT03246321|"     Summary intended for the lay public        -  Background of study: approximately a quarter of the patients who are diagnosed with          colorectal cancer and metastases have their metastases in the peritoneum, the so called          peritoneal metastases. The vast majority of these patients cannot be cured by surgery,          frequently due to too many peritoneal metastases. These incurable patients have a very          short life expectancy. Nowadays, they are treated with chemotherapy through the veins.          However, chemotherapy through the veins appears to be relatively ineffective against          peritoneal metastases, probably because it does not reach the peritoneal metastases very          well. Chemotherapy through the veins may also cause side effects that are sometimes          severe. Recently, doctors developed PIPAC: a short laparoscopic operation during which          chemotherapy is sprayed in the abdomen for 30 minutes, directly against the peritoneal          metastases. As a result, PIPAC may be more effective against peritoneal metastases than          chemotherapy through the veins. It may also have less side effects, because the          chemotherapy mainly stays in the abdomen, not in the veins. PIPAC indeed shows promising          results in the first European patients with peritoneal metastases of colorectal cancer          who have been treated with this operation.        -  Aim of study: to investigate whether PIPAC is a safe, feasible, tolerable, and          potentially effective treatment for patients with peritoneal metastases of colorectal          cancer.        -  Participants: patients with peritoneal metastases of colorectal cancer, without          metastases elsewhere (e.g. liver, lung), who cannot be cured by surgery due to too many          peritoneal metastases.        -  Treatment: instead of chemotherapy through the veins, participants receive PIPAC. PIPAC          is a laparoscopic operation under general anesthesia. The entire operation takes about          90 minutes. After the operation, patients stay in the hospital for at least one night.          PIPAC is repeated every 6 weeks. The aim is to perform 3 PIPACs. If the peritoneal          metastases respond well to PIPAC, participants may undergo more than 3 PIPACs.          Participants may also undergo less than 3 PIPACs: for example if the peritoneal          metastases do not respond PIPAC, if laparoscopy is unsafe for the patient, or if the          surgeons cannot perform PIPAC due to adhesions in the abdomen. In case no further PIPACs          can be performed, participants receive chemotherapy through the veins.        -  Other appointments: four weeks after each PIPAC, participants visit the hospital for a          CT-scan and an appointment at the oncological outpatient clinic to evaluate whether a          next PIPAC can be performed. If not, participants receive chemotherapy through the          veins. After the last PIPAC, patients visit the oncological outpatient clinic every 3          months to evaluate how the cancer responds to the treatment.        -  Potential risks for participants: PIPAC may cause side-effects. The most frequent          potential side-effects are pain, nausea, fever, wound infection, diarrhea, obstipation,          and minor damages to the kidney, liver, and bone marrow. These side-effects are mostly          very mild. Moreover, the risk of side-effects of PIPAC is thought to be lower than the          risk of side-effects of chemotherapy through the veins. Severe side-effects of PIPAC are          extremely rare. The most important are a bowel perforation or a bleeding during PIPAC.          So far, these severe side-effects have not been observed during PIPAC in patients with          peritoneal metastases of colorectal cancer.        -  Potential benefits for participants: PIPAC may potentially be similarly or even more          effective against peritoneal metastases than chemotherapy through the veins, with a          potential lower risk of side-effects. There may be a small chance (+/- 10%) that the          peritoneal metastases become so small that they can be cured by surgery. However, these          potential benefits are uncertain. The cancer may deteriorate at any moment during          treatment with PIPAC.        -  Hypothesis of study: the investigators expect that PIPAC is a safe, feasible, and          tolerable treatment for patients with peritoneal metastases of colorectal cancer, with a          potentially similar or higher efficacy against peritoneal metastases of colorectal          cancer compared to chemotherapy through the veins.   "
3026|NCT03246308|"     Research project in which blood samples of patients undergoing UVB phototherapy for the     treatment of different cutaneous diseases will be investigated for changes of folate levels     and further vitamins over the course of treatment.   "
3028|NCT03246282|"     This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150)     subjects presenting with pain will be enrolled into a single treatment group The purpose of     the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain     reduction, through change between baseline average pain and final average VAS score. The     absence of a control group is based on the following reason: The purpose of this     investigation is to further the understanding of the feasibility of PLEDS for PIV catheter     light delivery for pain management. Further, the results of this investigation will be used     (internally only) to determine if subject-perceived reductions in pain warrant proceeding     with more controlled, targeted and possibly randomized studies.   "
3029|NCT03246269|"     This observational cohort study in healthy volunteers establishes normative data for the     German version of the Montreal Cognitive Assessment (MoCA) and investigates the possible     impacts of demographics on the MoCA total score.   "
3030|NCT03246256|"     The aim of the study is to investigate the ability to recall information given during     informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.   "
3420|NCT03241160|"     The study is planned to determine the relationship between chewing performance level and     gross motor function, and trunk postural control in cerebral palsy (CP).   "
3032|NCT03246230|"     Infection is the most common cause of death in early life, especially for newborns and can be     reduced by immunization but insufficient knowledge of how vaccines protect the very young     limits their optimal use. To gain insight into how vaccines induce protection of the most     vulnerable, this National Institutes of Health (NIH)/National Institute of Allergy &     Infectious Diseases (NIAID)-funded Human Immunology Project Consortium (HIPC) study, based at     Boston Children's Hospital and conducted by the Expanded Program on Immunization Consortium     (EPIC), employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV):     (a) systems biology that uses technologies which comprehensively measure global changes in     molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell     composition of the blood and (b) use of human newborn blood components, collected prior to     immunization, to model vaccine responses in vitro (outside the body). Characterizing     vaccine-induced molecular patterns (signatures) that correspond to vaccine-mediated     protection will accelerate development and optimization of vaccines against early life     infections of major global health importance.   "
3033|NCT03246217|"     Research has shown that music engages the brain bilaterally throughout cortical and     subcortical regions, accessing extended sensorimotor, cognitive and affective networks. This     research explores the hypothesis that use of these shared neural networks allows neurologic     music therapy interventions targeting upper extremity motor control to promote plasticity and     functional improvements in persons recovering from a cerebrovascular accident. The potential     therapeutic benefits of these interventions on attentional processes and affective responding     will also be examined.   "
3034|NCT03246204|"     The study is an observational, multicenter, prospective cohort study aimed at evaluating a     5-year screening programme for chronic kidney disease(CKD) in a population of elderly     patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum,     the incidence of complications and co-morbidities.To assess the correlation between daily     living ability, mental and physical function, quality of life, nutritional status and     prognosis.To develop biomarkers of renal aging.   "
3035|NCT03246191|"     The study is an observational, cross-sectional study aimed at screening and accessing risk     factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate     the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy     malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To     develop biomarkers of CKD.   "
3036|NCT03246178|"     This is a prospective case-control study on SAA patients treated with HSCT, order to further     discuss and assess the safety, feasibility and effectiveness of HFD-HSCT which performed with     reduced-intensity fludarabine-based conditioning regimen.Our findings would indicate that SAA     patients who lack MSD benefited most if HFD-HSCT was performed with reduced-intensity     fludarabine-based conditioning regimen, and our improved outcomes with HFD-HSCT may lead to a     salvaged therapy and an expanded direct role for SAA in the future.   "
3037|NCT03246165|"     The objective of this research was to determine the incidence, predisposing and triggering     factors of delirium following cardiac surgery and its consequences within 30 days of surgery     and during a 12-18-month follow-up in older adult patients.   "
3038|NCT03246152|"     Anti-vascular endothelial growth factor (VEGF) drugs are the mainstay of therapy for diabetic     macular edema (DME), substantially improving visual acuity for many diabetics worldwide, and     proving effective for treatment of both non-proliferative and proliferative diabetic     retinopathy.      Many studies such as Diabetic Retinopathy Clinical Research Network studies, RESTORE Study,     and The BOLT Study have supported the use of different anti-VEGF agents in the treatment of     DME with better visual outcomes using anti-VEGF injections alone or in combination with other     treatments.      Several ocular complications of intravitreal anti-VEGF injections have been reported     including endophthalmitis, cataract and retinal detachment. The effect of anti-VEGF drugs on     macular perfusion has been inconclusive, with mixed reports of increase, decrease or no     effect on perfusion in response to anti-VEGF treatment. In many of these studies, however,     patients with more ischaemic retinas were not included. Retinal ischemia is an important     factor in the progression and prognosis of diabetic retinopathy.      Fluorescein angiography (FA) was the method used to assess changes in macular perfusion after     anti-VEGF injections in most of the studies. Despite its clinical usefulness, however, FA is     known to have documented risks. Optical coherence tomography angiography (OCTA) is a new     noninvasive method of acquiring high-resolution images of the retinal vasculature that can be     utilized in the treatment of retinal disease without the need for dye injection. It allows     the visualization of the superficial and deep retinal capillary layers separately and the     construction of microvascular flow maps.      Several studies have proved the reliability of OCTA in detecting and quantifying macular     ischemia in diabetics.      In this study, investigators aim to evaluate the effect of repeated intravitreal injections     of different Anti-VEGF agents on the perfusion of different capillary layers in the macula of     diabetic patients using OCTA.   "
3039|NCT03246139|"     The specific study aims will be:        1. To investigate the short- and long-term treatment effects of action observation,          imagery, and execution therapy (AOIE) compared with an action observation therapy (AO)          group and a customary rehabilitation group as controls on different aspects of outcomes          in patients with stroke.        2. To examine the neural mechanisms and changes in cortical neural activity after the          interventions in stroke patients.        3. To examine the correlations between AOIE-induced brain activation changes and the          clinical efficacy of AOIE.        4. To identify who are the possible good responders to the therapy based on baseline motor          function and motor imagery ability of the participants.   "
3040|NCT03246126|"     The purpose of this study is to evaluate the use of an investigational device called the     ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of     thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major     artery leading away from your heart) that originates in your chest and extends to your     abdomen and also includes the branch arteries that supply blood to the liver, spleen,     intestine, kidneys and other organs in your abdomen. The word investigational means the     device is still being tested and is not approved by the Food and Drug Administration (FDA)     for sale in the United States.   "
3041|NCT03246113|"     The goal of this single arm Phase I feasibility study is to investigate the tolerability of     cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A     strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high     concentration of cannabidiol (CBD) and a low concentration of THC (relative to average street     cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating     side effects in this medically-ill population.   "
3421|NCT03241147|"     This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to     subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects   "
18216|NCT03047096|"     The aim of present study is to to investigate whether the combined injection of HA and CS was     superior than HA alone in the treatment of knee OA.   "
3042|NCT03246100|"     This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are     slight changes to methods and a different cohort will be used, thus justifying a 2nd     ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in     Colorado. Each state has it's own ClinicalTrials.gov submission.      Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,     only about half of children are vaccinated annually leading to substantial influenza disease     in children and spread of disease to adults. A major barrier is that families are not     reminded about the need for their children to receive influenza vaccination. The     investigators will evaluate the impact of patient reminder/recall (R/R) performed by state     immunization information systems to improve influenza vaccination rates by using three     clinical trials in two states. The investigators will assess effectiveness and     cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall     versus 3) usual care (no R/R) on improving influenza vaccination rates.      The investigators will disseminate the state immunization information system based     reminder/recall system to all states for use for both seasonal and pandemic influenza     vaccinations with the goal of lowering influenza morbidity.   "
3043|NCT03246087|"     The purpose of this study is to determine if the addition of acupuncture to a standard of     care prescribed exercise program is more effective at improving pain and function in adult     patients with plantar fasciosis.   "
3044|NCT03246074|"     This research is being done to test the safety of the combination of the study drugs     fostamatinib and paclitaxel. This study tests different doses of the drugs to see which doses     are safest in people with ovaria cancer when given together.   "
3045|NCT03246061|"     Subjects will be randomized 1:1 Radio Frequency (RF) Ablation arm vs Control arm; this is an     open-label trial. Subjects in the the RF Ablation arm will receive the Intracept System     procedure to treat one or two motion segments. Subjects in the Control arm will continue on     non-surgical management therapies to treat their chronic low back pain (CLBP) and will be     offered optional crossover after 12 months of follow-up.   "
3046|NCT03246048|"     Objectives:      The general objective of the present project is to gain a better understanding of disease     outcome in cACLD patients treated with the new oral DAA. In particular, the project will     focus on:      - To evaluate the long term prognosis of patients with compensated advanced chronic liver     disease (cACLD) who achieve sustained virological response (SVR) after the new oral     direct-acting antiviral agents (DAA), and determine clinical and elastographic basal and     follow-up parameters to identify low and high risk groups of developing liver-related     decompensation.      Methods:      Prospective cohort study in patients with cACLD in whom basal and annual clinical features     and liver stiffness measurements (LSM) will be performed, and survival free of liver-related     events will be analyzed.   "
3047|NCT03246035|"     A randomized study designed to determine whether telephone based interventions can prevent     return hospital visits for elderly and frail patients with acute symptoms of heart failure.     Specifically, the intervention will improve patients ability to monitor and address self care     of heart failure at home.   "
3048|NCT03246022|"     Obstructive sleep apnea syndrome (OSAS) is a common disorder characterized by recurrent     obstruction of upper airway, leading intermittent oxygen desaturation and repetitive arousals     during sleep, which can cause enhanced sympathetic activity, elevated levels of vasoactive     substance concentration and vascular damage, and therefore, increase the risk of hypertension     Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the     occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has     been widely used in clinical. In theory, CPAP maintains upper airway patency and preserves     ventilation, thereby inhibits the chain reaction over activation of the sympathetic nervous     system and blood pressure regulating mechanism, thus CPAP treatment have adequate scientific     basis to cause a substantial reduction arterial blood pressure, but controlled studies showed     either no effect or only a minor decrease in arterial blood pressure by 1.4 and 2.5 mmHg     respectively.The current, which type of combination of hypertension OSA patients can obtain     the best antihypertensive benefit from CPAP therapy is still under debate.      Previous studies have shown that frequent blood pressure fluctuations associated with     respiratory events can lead to increased blood pressure levels at night and even during the     daytime in patients with severe OSA with hypertension. Continuous monitoring of nocturnal     blood pressure fluctuations in OSA patients, not all OSA patients exhibited significant     apnea-related nocturnal BP surges, some patients' nocturnal blood pressure fluctuations were     independent of respiratory events, some spontaneous contractions, without respiratory events,     micro-arousal, and leg movement ,which can lead to transient increases in blood pressure.     Moreover, some patients did not show significant BP fluctuation but with high baseline BP     level. If hypothesis that nocturnal BP fluctuation was irrelevant to the respiratory events     or no obvious BP fluctuations existence during sleep, in these case, even if apnea or     hypopnea events were eliminated by CPAP treatment, but a low size in antihypertensive effect.     If BP fluctuations were the closely related to respiratory events and frequent nocturnal BP     fluctuations resulted in daytime and nocturnal hypertension, in these case, CPAP treatment     can significant lower both daytime and nocturnal BP level. A number of previous studies have     shown that the efficacy of CPAP in decreasing BP level was unsatisfied. The investigator     supposes whether or not during the process of recruitment, the characteristics of blood     pressure fluctuation of OSA patients were not considered and result in a false judgment that     the inefficacy of CPAP treatment on lowering BP levels.   "
3049|NCT03246009|"     The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast     cancer patients with different doses and multiple injections.      To observe the pharmacokinetic characteristics of recombinant human serum albumin     /granulocyte colony-stimulating factor fusion protein after single and multiple     administration   "
3050|NCT03245996|"     This study evaluates the acute effects of heart rate (HR) change on central hemodynamic     parameters noninvasively.   "
3089|NCT03245489|"     The purpose of this study is to see if anti-platelet therapy combined with anti-PD-1     immunotherapy can cause a more favorable immunologic response thatn with immunotherapy alone     in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.   "
3065|NCT03245801|"     Juvenile Idiopathic Arthritis (JIA) is a disorder of unknown cause characterized by chronic     inflammation of the joints and other organs. It affects about 1 in a 1000 Canadian children     and if untreated it can produce lifelong disability. The Canadian Alliance of Pediatric     Rheumatology Investigators (CAPRI) includes most pediatric rheumatologists in Canada. They     have successfully collaborated for the past 10 years producing groundbreaking research on the     modern course and outcomes of JIA. CAPRI proposes an ongoing universal registry of Canadian     children with JIA that will collect longitudinal data on disease course, outcomes and adverse     events to inform healthcare decisions and to gain new insights into the disease and its     treatment.   "
3110|NCT03245216|"     The study is designed to assess the effects of aerobic exercise on motor learning in     Parkinson patients. Specifically, the investigators examine whether a single bout of moderate     intensity aerobic exercise, performed immediately before task practice, facilitates the     acquisition and retention of a motor skill. In a cross-over design, participants will be     randomly allocated to either the intervention group (aerobic exercise before motor learning)     or control group (rest before motor learning).   "
3051|NCT03245983|"     The general aim of research is to identify and analyze the impact and role of spirituality     (as a search for meaning and understanding of the meaning of existence) in the experience of     cancer. For this purpose, the main objective of this study is to measure the existential     component in the trajectory of the disease. It is a question of observing its potential     contribution to the improvement of the quality of life of the patients and to define if this     variable can be translated into a strategy of adjustment for the patients. This research has     a double interest: (a) clinical interest in better managing patients' needs; (B) an interest     in research in the field of health by combining a measure of spirituality with other     psycho-social variables.      The project is a prospective non-randomized mono-centric study by questionnaire and research     interview. It is a study that seeks to identify the role of spirituality in the experience of     illness (i.e. representations, adjustments, emotional distress) and as a determinant of the     quality of life of subjects with cancer pathology.      The interviews will be conducted by a psychologist to qualitatively collect the elements of     the lived experience of the disease in connection with the spiritual elements of the quest     for meaning type.      The population covered by the project is in and out patients coming to the Department of     Medical Oncology and Palliative Care at the CHU de la Timone.      The realization of this project will allow investigators to explore the specificity of the     existential / spiritual dimensions of patients confronted with cancer, to assess the     patients' needs for this type of approach within the hospital, to link the existential     component / Spiritual with psycho-social variables   "
3052|NCT03245970|"     To determine if the use of impedance cardiography can identify appropriate medications for     use in treating chronic hypertensive patients to decrease the risk of preeclampsia.   "
3053|NCT03245957|"     The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL     dysfunction during the acute stage of ischemic and haemorrhagic strokes.   "
3054|NCT03245944|"     Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but     many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is     unknown.The study proposes a randomized clinical trial comparing the clinical and economic     impact of early vs late angioplasty in non-maturing AVFs.      The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of     non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6     months, but a greater long-term AVF patency , lower requirement of subsequent interventions     to maintain AVF patency for dialysis, and lower overall cost of access maintenance.   "
3055|NCT03245931|"     The goal of this study is to assess the health literacy level of patients enrolled in the     HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that     may influence patients' knowledge, and educate patients on Hepatitis C.   "
3056|NCT03245918|"     Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and     vomiting (CINV) are still common and are among the most distressing side effects of     chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid     aprepitant formulation would be ideal for oral administration to patients unable to swallow     capsules.   "
3057|NCT03245905|"     This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide     as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's     Lymphoma (NHL).   "
3058|NCT03245892|"     The purpose of this study is to find out what effects, good or bad, the addition of nivolumab     to typical chemotherapy has on the patient and their cancer.   "
3059|NCT03245879|"     Core elements of effective antibiotic stewardship programs (ASPs) have been identified and     evidence-based guidelines have been developed for implementation. The majority of the     evidence used for these guidelines are from published studies on the effectiveness of ASPs in     large academic or large community hospitals. A significant portion of healthcare in the     United States, however, takes place in small hospitals. In 2015, 73% of US hospitals had <     200 beds (4,057 hospitals) and accounted for 29% of all US inpatient bed days. Limited     studies on the effectiveness of antibiotic stewardship implementation have been performed in     hospitals with < 200 beds. Antibiotic use rates and selection patterns in these small     hospitals are similar to that of large hospitals and the majority of small hospitals lack     formal ASP that meet the CDC's core elements. The objective of this real-world implementation     study was to assess the effectiveness of three ASP strategies of escalating intensity     designed specifically for small hospitals within a vertically integrated healthcare delivery     system.   "
3060|NCT03245866|"     This registry was created to assess management parameters of patients treated for aneurysmal     subarachnoid hemorrhage in Switzerland. All Swiss hospitals with a neurosurgery department,     an intensive care unit and an interventional neuroradiology team that treat neurovascular     emergencies participate in the registry. Clinical parameters are entered into a common     database. This database will provide (1) a nationwide assessment of the current standard of     care and (2) the outcomes for patients in Switzerland including neuropsychological     assessments.   "
3061|NCT03245853|"     Epithelium-On Corneal Crosslinking for Keratoconus.   "
3062|NCT03245840|"     This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents     with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302     extension study. The purpose of this study is to see if BOS is safe and well tolerated over     the long-term in adolescents and adults with EoE.   "
3063|NCT03245827|"     Obesity can lead to low testosterone concentrations in young men. This study will study the     effects of low testosterone in those men and the result of treating them with clomiphene.   "
3064|NCT03245814|"     The purpose of this study is to quantify the therapeutic efficacy and role of trained service     dogs on socio-emotional functioning among military veterans with posttraumatic stress     disorder (PTSD).   "
3103|NCT03245307|"     Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2（VEGFR-2）,     inhibits multiple cytochrome P450 (CYP450) enzymes in vitro. This study in patients with     advanced cancer evaluated the effect of Apatinib on CYP450 function by comparing the     pharmacokinetics of CYP-specific probe drugs in the presence and absence of Apatinib. The     probes used included Nifedipine (CYP3A specific), warfarin (CYP2C9 specific).   "
13393|NCT03110120|"     The aim of the study is to compare the analgesia provided by the serratus plane block with     local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.   "
3066|NCT03245788|"     The Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the     quality of care, make it more patient-centered and coordinated across the continuum of care.     The newest innovation is to introduce lay navigators to specified high-need patients. The     larger goal of the project is to assess whether lay navigators can address non-clinical     patient needs in a timely fashion and appropriately connect them with their clinical team     when warranted. It is expected that proactive interaction with patients will decrease patient     anxiety/stress related to their cancer and facilitate higher patient engagement and improved     management of physical, social,and emotional health. For the pilot project, the smaller goal     is to understand: how lay navigator time is used; the types and frequency of issues brought     up by patients; resources that patients are given or referred to; type and frequency of mode     of contact with patients; and patients' acceptance of navigators based on refusal. An     electronic intake form will be used to collect this information so that data can be analyzed     regularly and informed change can be made to the navigator program as needed   "
3067|NCT03245775|"     The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and     12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to     determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for     implementation and sustainability, (3) relative impact on family eating/physical activity and     parental weight, and (4) relative adherence and potential dose response relationships.   "
3068|NCT03245762|"     The purpose of this study is to compare the change in suck and swallow competency from     baseline to day 5 with intranasal oxytocin spray vs placebo in infants/children with     Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will     be performed on treatment day 1 and on the day following treatment day 5   "
3069|NCT03245749|"     The purpose of this study is to investigate the effect of habitual oily fish intake, sex,     age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.   "
3070|NCT03245736|"     The purpose of the trial is to evaluate efficacy and safety of continued treatment with     tisotumab vedotin.   "
3071|NCT03245723|"     The purpose of this research is to determine the effect of premature birth on later heart     function and metabolism.   "
3072|NCT03245710|"     This study investigates the efficacy and mechanism of traditional Chinese medicine formula     power product in the treatment of osteopenia in patients with pain. Half of participants will     receive Chinese medicine formula power product, while the other half will receive a placebo.   "
3073|NCT03245697|"     Human milk is not a uniform body fluid, but quite the opposite, its composition changes     continuously adapting to the requirements of the newborn. It can be considered as the gold     standard for infants' nutrition and exclusive breastfeeding is recommended by the WHO during     the first months of life. Additionally, its composition should be used as reference or     guidance for defining optimal nutrient intakes for infants that cannot be fully breastfed. In     that connection, the nutritional status and dietary habits/patterns of the mother, along with     certain genetic traits, exert also influence over breast milk. Considering all these facts,     and their great impact on (present and future) infant health, detailed information of breast     milk composition is required for specific populations, covering as many factors, elements and     nutrients as possible.      In the present observational study, research is focused on breast milk in northwestern Spain,     more precisely Galicia. In this context, the obtained data will serve to define the     nutritional characteristics of breast milk from Galician women (interindividual variation),     while at the same time evaluating the existence of specific features related to their     particular diet (dietary factors), the Southern European Atlantic Diet (SEAD). All the     variables measured in this research project will be related with breast milk composition.     Expected primary outcomes can be divided as follows: fatty acid profiles, mineral     composition, essential amino acid profiles, microbiota and steroid hormones. The key     influencing factors taken into account are: lactation characteristics and maternal diet.      Recruitment of participants is based on all the following criteria, with no exceptions:     female, living in Galicia, lactating, > 18 years old, volunteer participation, written     informed consent and agreement to complete questionnaires about lactation, diet and other     socio-demographic factors. Samples are collected by participants, and stored at the     University of Santiago de Compostela under a coded system so that it is impossible to     identify the donor from whom the sample comes, with the exception of the investigators. The     project is adhered to the principles of the Helsinki Declaration. Participants are allowed to     withdraw their consent at any moment of the study.   "
3074|NCT03245684|"     The present pilot randomized controlled clinical trial will test the hypothesis that in     patients with ARDS, fixing ventilator settings to the conventional protective ventilatory     strategy (VT 6 ml/kg ideal body weight and Pplat ≤ 30 cmH2O, PEEP according the PEEP/FiO2     table), control modes of mechanical ventilation will be associated to a concentration of     pulmonary and systemic inflammatory mediators lower than the concentration of inflammatory     mediators observed during assisted modes of mechanical ventilation.   "
3075|NCT03245671|"     Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number     of individuals, and there is a general lack of consensus in the medical community in terms of     effective treatments for this problem. By assessing the relative efficacy of transforaminal     epidural injections of particulate and nonparticulate steroids, this study attempts to     further define the appropriate conservative management of painful unilateral radiculopathies     due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a     transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate     (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months     following the injection.   "
3104|NCT03245294|"     The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure     from ligamentum flavum to epidural space and analyzing factors contributing this pressure     change pattern.   "
3105|NCT03245281|"     The purpose of this non-randomized, cross-over, unblinded, single-center feasibility study is     to assess the sensitivity of the LINQ ICM to measure derived-subcutaneous impedance in     patients with heart failure during periods when diuretics and/or HF-medication consumption is     increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect     safety information related to HF status and to medication consumption changes.   "
3107|NCT03245255|"     This study will use contrast echocardiography to assess the accuracy of a new non-invasive     imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously     acquired intra-cardiac pressures measured invasively during cardiac catheterization. This     study is designed to verify that contrast echocardiography using the SHAPE method, already     proven in a canine model and tested in a human pilot study can be used as a surrogate for     cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.   "
4582|NCT03225872|"     Osteosarcoma is very rare cancer of the bone. The investigator started the BOOST registry and     biobank to make sure every patient has the opportunity to participate in research.   "
3076|NCT03245658|"     The prevalence of malnutrition is overwhelming in pancreatic cancer patients, >80% experience     a weight loss >10% of their habitual weight, which may develop into cancer cachexia. Cachexia     may cause decreased quality of life, increased mortality and morbidity e.g. poorer response     to antitumor treatment, longer length of stay, higher complications rate and shorter life     expectancy. There is currently no effective treatment of cancer cachexia, but clinical     research in medical cannabis show promising results. The cannabinoids THC and CBD show the     highest pharmacological effect, but cannabis consists of >70 cannabinoids. THC and CBD exert     their effect on the endocannabinoid system which modulate physiological systems such as pain,     inflammation, appetite and energy balance. Thus, this potential orexigenic effect from THC     and CBD may improve the nutritional state in patients with pancreatic cancer. Taking the     above scientific rationale and the lack of evidence into account, the relevance of this     clinical trial appears high.      This clinical trial is an eight-week crossover design examining the effects of the     cannabinoids THC and CBD on energy- and protein intake and lean body mass as a measure of     appetite, nausea and quality of life. A characterization of the metabolism is analysed     through a metabolomics analysis.   "
3077|NCT03245645|"     The purpose of this study is to determine the amount and timing of when certain Fermentable     Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely     reintroduced into the diet of Irritable Bowel Syndrome (IBS) patients that have successfully     completed a low-FODMAP elimination diet. The FODMAP diet is an effective treatment for IBS;     however it is unclear how patients can successfully reintroduce and liberalize fructose into     their diet. The low FODMAP diet is thought to reduce IBS symptoms by decreasing water content     and gas production in the bowel and also possibly by altering gut bacteria. Although use of     the FODMAP elimination diet can initially successfully treat IBS symptoms for up to 50-75% of     patients, the reintroduction diet is difficult for patients to complete and maintain for long     periods of time because current methods for reintroduction of FODMAPs are imprecise leading     to frequent recurrent symptoms. As a result, patients often continue the low FODMAP     elimination diet for additional months because they have difficulties knowing how to add back     Protocol ID:IRB#16-000934 UCLA IRB Approved Approval Date: 2/22/2017 Through: 9/20/2017     Committee: Medical IRB 1 FODMAPs into their diet. There are no studies to date to help guide     patients with FODMAP reintroduction. For example, in the case of reintroducing fructose,     patients currently are currently instructed to add back honey into their diet over a 3-day     period using honey in 1- 3tsp doses (equivalent roughly to 2.86-8.6 grams of fructose).     However, honey is a sweetener made of both fructose and glucose and it is unclear whether     recurrent IBS symptoms are related to the concentration of fructose or the concentration of     fructose that is in relative excess to glucose. These types of confounding problems make it     difficult to generalize dietary reintroduction. The three study groups (i.e. fructose,     glucose, fructose/glucose) in this study are designed to determine if and how fructose leads     to recurrent IBS symptoms during the reintroduction diet. The fructose group will help to     determine whether an absolute amount of fructose will lead to IBS symptoms. Based on the     principals of the diet, we hypothesize IBS patients have lower thresholds for fructose     tolerance.      The glucose group will serve as a control since glucose is not a FODMAP and as a result is     not expected to lead to recurrent symptoms. The glucose/fructose mixture group is a cross     comparison group that will determine whether the relative excess fructose concentration is an     important cause of IBS symptoms. Fructose absorption in the gut is dependent on glucose     intake as fructose is transported with glucose from inside the gut into the body. Current     studies suggest that fructose intolerance in healthy controls is highly dependent on the     ratio of excess fructose to glucose.      The fructose/glucose treatment group is designed to investigate this potential relationship.   "
3078|NCT03245632|"     Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection.     Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the     clinical therapy be very difficult. However, there is not much empirical data as to the     prevalence, risk factors, characteristics, and the rationality of the current therapy for the     CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors,     characteristics, and the rationality of the current therapy for the CRKP infection.   "
3079|NCT03245619|"     GSK3335065 is being developed as a treatment for acute pancreatitis with the intent of     reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them     at this level throughout the treatment period. This study will utilize an adaptive design and     is divided into 3 parts. Part A will consist of two cohorts (1-2) and is Single Ascending     Dose (SAD) of GSK3335065 by IV bolus in males. Part B will be initiated after completion of     dosing in Part A. It will involve ascending IV bolus doses of GSK3335065 followed by IV     constant infusion for 7 days in males and will consist of four cohorts (3-6). Part C consists     of a single dose of GSK3335065 by IV bolus (cohort 7), and a single dose followed by     continuous infusion over 7 days (cohort 8) in females of non-child bearing potential     (WONCBP). Total 64 subjects will be evaluated in the study of which Part A will include 16     healthy male subjects, Part B will include 32 healthy male subjects and Part C will include     16 WONCBP. Part A will last up to 19 weeks and Part B will last up to 13 weeks. In Part C     cohort 7 will last up to 7 weeks and cohort 8 will last for 13 weeks.   "
3080|NCT03245606|"     The main objective is to compare the accuracy of transient elastography taking into account     liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in     patient with NAFLD.   "
3081|NCT03245593|"     The investigators hypothesize that implementation of a shared decision making care plan for     prophylactic treatment will help therapeutic adherence of bipolar patients. They also     anticipate that patients treated according to a shared decision making plan will have an     elevated satisfaction of their care, quality of life and functionment, as well as a lower     number of relapses   "
3082|NCT03245580|"     The primary purpose of this prospective, randomized, multicenter study is to evaluate and     compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2     different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques:     modified Wet suction and Slow pull technique of collecting tissue from a liver biopsy via     Endoscopic Ultrasound (EUS).   "
3083|NCT03245567|"     This study is designed to:        1. Implement a Web platform intended to host perceptual learning modules (PLMs)        2. Implement and assess a PLM designed to improve the capacity of first-year residents to          visually estimate the left ventricular ejection fraction (LVEF) with transesophageal          echocardiography (TEE) images.      The hypothesis of the study is that the PLM will improve the visual assessment of LVEF by TEE     in junior residents.   "
3084|NCT03245554|"     To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal     cancer.   "
3085|NCT03245541|"     This study is being done to determine the safety and tolerability of durvalumab in     combination with stereotactive ablative radiotherapy (SABR), a standard radiation treatment,     for patients with pancreatic cancer.   "
3086|NCT03245528|"     The primary objective of the study is to provide access to LJPC-501 for distributive shock     patients who remain hypotensive despite receiving fluid and vasopressor therapy.   "
5119|NCT03218852|"     This study is an extended follow-up of the study (ClinicalTrials.gov ID:     NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of     prednisone alone in patients with advanced-stage IgA nephropathy.   "
3090|NCT03245476|"     This study aims, by means of a randomized control trial, to investigate which treatment     method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises     versus corticosteroid injection + physiotherapy with focus on education and supported home     exercises) gives better results on clinically relevant outcomes (range of glenohumeral     motion, psychological factors, pain, shoulder function, quality of life) and on parameters     derived from arthroscopic glenohumeral investigation by means of MRI.      Furthermore, associations between (1) the results on the MRI investigation, (2) the range of     glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be     assessed at different time-points (before and at 6-12-18 and 52 weeks after the first     injection).   "
3091|NCT03245463|"     Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence,     and even safety of the individuals who suffer from it. One of the most powerful tools for     these patients can be education on self-care and self-management strategies that can be     taught to a patient by a physician, physical or occupational therapist, or a nurse. These     self-management strategies can help patients treat daily stiffness through exercise or manage     flares of osteoarthritis. There is a lack of consensus on the best teaching methods to     accomplish the goal of educating our patients. Feedback from both patients and providers     regarding teaching methods is needed. This study will evaluate teaching methods on     self-management strategies for patients who are undergoing hyaluronic acid injections for     knee osteoarthritis.   "
3092|NCT03245450|"     The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and     Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan     hydrochloride in pediatric participants with relapsed/refractory extra-cranial solid tumors.      The Phase 2 part of the study is conducted to assess the objective response rate (ORR) of     eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with     relapsed/refractory rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma     (NRSTS).   "
3093|NCT03245437|"     This study will measure whether the engagement of intranasal oxytocin with a brain target is     related to effects on learning during a social cognition training program.   "
3094|NCT03245424|"     To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute     myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.   "
3095|NCT03245411|"     Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The     majority of patients have a diverse cultural background, low literacy, and poor     social-economic status. Medication adherence for chronic medical problems is in a range of     40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in     detail. The main objective is to study medication adherence to oral anticancer agents in     patients with low literacy and poor socio-economic status.   "
3096|NCT03245398|"     This study is a double-blind randomized clinical trial which aims at providing evidence on     the efficacy and safety of two regimens of mebendazole in school-aged children. Thus, our     primary objective is to assess the efficacy and safety of: i) 100 mg solid tablets twice a     day for 3 days, and ii) one dose of 500 mg solid tablets of mebendazole in participants aged     6-12, inclusive, infected with hookworm.      The primary endpoint of the trial is the cure rate (CR) of the 3-day regimen of mebendazole     against hookworm and a single dose mebendazole treatment.      The secondary objectives are to determine if the multi-dose regimen is superior to the single     dose regimen, evaluate the efficacy against concomitant soil-transmitted helminth infections,     and assess the safety of both mebendazole regimens.      After obtaining informed consent from children's caregiver, the medical history of the     participating individuals will be assessed with a standardized questionnaire, in addition to     a clinical examination carried out by the study physician on the treatment day. Enrollment     will be based on two stool samples which will be collected, if possible, on two consecutive     days or otherwise within a maximum of 5 days apart. All stool samples will be examined with     duplicated Kato-Katz thick smears by experienced laboratory technicians.      Randomization of participants into the two treatment arms will be stratified according to     intensity of infection. Participants will be interviewed before treatment for clinical     symptoms and 3 hours after every morning treatment and 24 hours after every morning treatment     about the occurrence of adverse events. The efficacy of the treatment will be determined     14-21 days post-treatment by collecting another two stool samples.      The primary analysis will include all participants with primary end point data (available     case analysis). Supplementary, two sensitivity analyses will be conducted imputing all     missing endpoint data as treatment failures or all as treatment success. CRs will be     calculated as the percentage of egg-positive participants at baseline who become egg-negative     after treatment. CRs will be compared by using unadjusted logistic regression. To assess     model robustness with respect to covariates, adjusted logistic regressions (adjustment for     age, sex, school, weight and strata) will be performed.      Geometric and arithmetic mean egg counts will be calculated for the different treatment arms     before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with     5,000 replicates will be used to calculate 95% confidence intervals (CIs) for ERRs and the     difference of the ERRs.   "
3097|NCT03245385|"     This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and     potential for adrenal suppression following topical treatment with halobetasol propionate     0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.     At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria     will be enrolled into the study   "
3098|NCT03245372|"     The primary aim of this study is to quantify and compare the hemodynamic control of cardiac     index in patients who receive either goal-directed therapy or standard hemodynamic management     in lung resection surgery   "
3099|NCT03245359|"     The purpose of this study is to determine if there is any significant difference between     using a short-term ON-Q nerve block (which is applied prior to surgery and maintained in     place until the medication in the initial balls have been fully used, usually 2-4 days) in     comparison to a long-term ON-Q nerve block (which is applied prior to surgery and maintained     in place up to seven days after surgery). This study will analyze patient reported levels of     pain, range of motion, and narcotic use, as well as investigate whether blood loss, blood     thinners, and hemoglobin/hematocrit blood levels influence patient pain levels.      This study will compare patient-reported pain, range of motion and narcotic use in total knee     arthroplasty patients who receive the short-term and long-term combination nerve block     (saphenous and posterior of the adductor canal and wide-field posterior knee.   "
3100|NCT03245346|"     The purpose of this randomized controlled trial is to investigate the effects of epidural     anesthesia and analgesia on the overall survival，disease-free survival and recovery in     patients undergoing pancreatic cancer surgery. This study will also evaluate the effects of     this technique on the neuroendocrine, stress and inflammatory response in these patients.   "
3101|NCT03245333|"     According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short     SGA children, further to evaluate the efficacy and safety of the treatment of short SGA     children.   "
3102|NCT03245320|"     A post market, non-randomized, multi-center, open-label,clinical study using survivorship to     study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when     used for total shoulder arthroplasty.   "
3111|NCT03245203|"     Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has     become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to     reduce the local recurrence rate, however, no improvement of distant metastasis rate was     observed, and the incidence of postoperative local recurrence and distant metastasis can     reach more than 25%. It is still a challenge for us to improve the RO resection rate of     locally advanced rectal cancer and reduce the incidence of local recurrence and distant     metastasis.   "
3112|NCT03245190|"     Chiauranib, which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases     involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory     microenvironment.   "
3113|NCT03245177|"     Lung cancer is the leading cause of cancer mortality worldwide and in the U.K alone; there     are 38,000 new cases of non-small cell lung cancer (NSCLC) a year. The new treatment being     tested in this study is called pembrolizumab, this is a type of immunotherapy, which works by     stimulating the body's own immune system to fight cancer cells.      Pembrolizumab blocks a protein on the T-cell surface (one of the cells of the immune system),     which then triggers the cell to find and kill cancer cells. This will be given with     radiotherapy to see if this combination is safe and effective at treating patients with     non-small cell lung cancer.      Pembrolizumab has proved to be a safe and effective treatment for other cancers such as     melanoma and lung cancer. Radiotherapy is often given as standard treatment to treat lung     cancer, and is proven to be a safe and tolerable treatment. However, the safety of the     combination of Pembrolizumab and thoracic radiotherapy delivered concurrently has not been     tested yet prospectively   "
3114|NCT03245164|"     This study aimed to compare the effects of group exercises under physiotherapist control and     basketball program on body composition and motor skills of obese children. 45 obese children     aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and     control group (n:15). The children were assessed before and after 12-week study duration.     Body Mass Index (BMI), the percentage of body fat, and circumference values of the children     were recorded. Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) was used     to determine motor skills of children.   "
3115|NCT03245151|"     Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum     tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of     lenvatinib administered in combination with everolimus once daily to pediatric participants     with recurrent/refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design,     will be conducted to estimate the antitumor activity of lenvatinib in combination with     everolimus in pediatric participants with selected recurrent/refractory solid tumors     including Ewing sarcoma/peripheral primitive neuroectodermal tumor (pPNET), rhabdomyosarcoma,     and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome     measure.   "
3116|NCT03245138|"     An endoscopic third ventriculostomy is considered to be successful in idiopathic normal     pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality     data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic     third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled,     multicenter study.   "
3117|NCT03245125|"     BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies.     High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF     patients, which was hypothesized to improve the survival of HF patients.      OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of     HF patients.      METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease     management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity     (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV     end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic     peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF     patients with LVEF> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were     classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the     interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up.     Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF     during at end of the study.   "
3151|NCT03244683|"     This is a single center, open label, randomized trial, involving 150 patients undergoing     pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7     days of ONS supplementation combined with resistance training and nutritional education     compared to standard of care, consisting of nutritional education alone.      This proof of concept study is intended to demonstrate the ability of pre-habilitation to     improve patient-related outcomes following pancreatic surgery, specifically postoperative     complications. The rationale for using the designated oral nutrient supplementation is to     preserve muscle mass, and decrease weight loss.   "
3118|NCT03245112|"     Since the first marketing authorization in the world in November 2010 granted by US FDA,     Halaven has been approved for clinical use in more than 40 countries worldwide, including     many Asian countries, e.g. Hong Kong, India, Japan, Malaysia, Myanmar, Philippines, South     Korea, Singapore, Taiwan and Thailand. According to two large global phase III study reports     of Halaven, very few Asian patients participated in these studies. In a phase II study of     Halaven with metastatic breast cancer, the clinical efficacy and toxicity were reported only     in 80 Japanese patients. Halaven has been granted its marketing authorization in Singapore     since February 2011. However, most of other Asian countries including India have had the     approval and launched from middle year of 2013 or in early 2014. Limited information of     Halaven using in Asian patients are available except several case experience exchange     presented by individual medical centers or as personal experience in the past. Some clinical     concerns related to Halaven use are raised by clinicians during their clinical practice, such     as how Halaven works on Asian patients, which type of patient obtains better clinical benefit     from Halaven, and what are the main treatment related toxicities in Asian which may differ     from Westerners due to potential ethnic diversity. Further understanding of Halaven related     clinical benefit and toxicity in Asian patients through collecting clinical experience among     Asian countries becomes necessary and may provide better information to anticipate these     concerns.      The proposed Halaven Patient Registry (called the Registry) will be a patient     population-based registry to collect therapeutic related information from patients with     metastatic breast cancer who were treated with Halaven that was given as a clinical decision     by patient's treating physician based on clinical status of a patient and proper indication     of Halaven and to gain a better understanding of the use of Halaven in such Asian patients.   "
3119|NCT03245099|"     Non convulsive status epilepticus is a persistent change in behavioural and or mental process     from baseline associated with continuous epileptiform activity in electroencephalograph,it     occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in     intensive care unit patients   "
3121|NCT03245073|"     In this project, investigators aim to investigate the effects of action observation therapy     on pain, fear of movement, functional level and brain hemodynamics in patients with knee     osteoarthritis. The study is unique in that this method, which has already been used for     post-surgical or motor healing, aims at long-term administration for the first time with     chronic pain and objective visualization of the results. This study will create a new     perspective to understand the physiology of pain, which has attracted much interest in the     literature in recent years, and will shed light on the studies that can be done in this     regard. Participants' joint range of motion in the initial assessments will be measured by     electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate     evaluation positions. In assessing pain, pain levels at rest and during activity will be     questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via     Tampa Kinesiophobia Scale and functional levels will be assessed via Western Ontario and     McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and Go Test. Functional     near infrared spectroscopy (fNIRS) will be used for evaluation of brain hemodynamics. The     first group, will receive exercises with action observation therapy; and the second group     will receive only exercises. The exercise programme will be administered under     physiotherapist supervision for three days a week for six weeks. The evaluations will be     repeated at the beginning of the study and at the end of the sixth week. Data obtained from     the study will be analyzed using appropriate statistical methods.   "
3122|NCT03245060|"     Around one third of stroke survivors will have aphasia, which means they will have difficulty     talking, understanding, reading or writing. The main aims of this study are to assess: [1]     the acceptability of an existing psychosocial intervention, solution focused brief therapy,     to people with varying presentations of aphasia; and [2] the feasibility of conducting a     future definitive trial investigating clinical and cost effectiveness.   "
3123|NCT03245047|"     The prevalence of malnutrition among the elderly in Asia is high. The objective of this     randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of     consuming an adult ONS plus dietary counseling (intervention group) for 180 days on     nutritional status and unexpected hospital (re)admission, compared with a placebo supplement     plus dietary counseling (control group).   "
3124|NCT03245034|"     This feasibility study develops methods for larger-scale research, evaluating the     acceptability and perceived impact of a group acupuncture and acupressure intervention, as     well as suitability of a self-report instrument. During their weekly training program, eleven     OB residents at NYU Lutheran Medical Center will receive three sessions of auricular     acupuncture therapy. (This resident population was previously anonymously surveyed and all     expressed interest in participating in such a study). The Professional Quality of Life Scale     (ProQOL) will be administered at 6 time points. A brief survey will also be given to assess     participants' acceptance of the intervention as well as applicability of the ProQOL     instrument. Additional feasibility-related outcomes include protocol compliance/withdrawals,     adverse events, and time taken to complete intervention and surveys.   "
3125|NCT03245021|"     Firstline treatment for grade 13a Follicular Lymphoma using Opdivo (nivolumab) plus     Rituximab: The 1st FLOR trial   "
3126|NCT03245008|"     The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to     placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients     with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate     the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.   "
3127|NCT03244995|"     The goal of this research study is to learn if a couple-based mind-body program can be used     during treatment for brain cancer and to learn the opinion of patients and their partners     about the program. A partner must be available and willing to take part in this study with     you in order for you to take part in this study.      Researchers also want to learn if and how this program affects your spiritual well-being,     sleep difficulties, depressive symptoms, and overall quality of life.   "
3153|NCT03244657|"     To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term     treatment of polypoid choroidal vasculopathy (PCV) subjects.   "
3157|NCT03244605|"     The investigators performed a multi-centered, randomized, placebo-controlled, prospective     clinical trial on the effect of comprehensive rehabilitation program to improve quality of     life(QOL) and long-term survival of postoperative patients with early lung cancer. The     investigators plan to enroll 236 cases in 3 years (118 cases for rehabilitation training plus     traditional Chinese medicine (TCM), 118 cases for rehabilitation education plus placebo),     expecting that comprehensive rehabilitation program has a better efficacy on improving QOL     and long-term survival.   "
3128|NCT03244982|"     Fluorescein angiography is a common procedure used in ophthalmology to diagnose and monitor     diseases of the eye. The standard dose of fluorescein dye used in fluorescein angiography is     500mg. It is common practice to give patients who have previously had an adverse reaction to     fluorescein dye a half-dose, or 250mg, of fluorescein. It has been determined by our     institution that anecdotally, there is no difference in image quality between the images     created by a half-dose of fluorescein versus a full dose of fluorescein. Therefore, this     study seeks to determine whether these doses are actually equivalent in terms of image     quality. Patients who consent to participate in the study will be randomized to receive     either a half or a full dose of intravenous fluorescein, and their images will be compared     objectively using image correlation technology, and subjectively using a masked team of     retinal surgeons. We hypothesize that there will be no significant difference between the     images obtained using a half-dose versus a full dose of intravenous fluorescein.   "
3129|NCT03244969|"     The aim of the research is to identify structural tissue changes in the early fracture     hematomas.   "
3130|NCT03244956|"     This is a multicentric prospective non-randomized phase II trial, with two independent arms:     one for patients with RAS mutation and one for patients with BRAFV600E mutation.   "
3141|NCT03244813|"     Our study aims to compare the effects of a standard care plan to one using adapted physical     activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will     allow the collection of quantitative and objective data related to activity in contrast to     questionnaires which are more subjective and dependent on self-representation. In addition,     the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide     interesting data from this population.   "
3131|NCT03244943|"     Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the     cytokine profile and the correlation to clinical parameters of patients undergoing     chemotherapy for breast cancer.      Materials and methods: 40 patients were allocated: Chronic periodontitis patients (PC) (n=20)     and breast cancer with chronic periodontitis patients (CAN/PC) (n=20). The clinical     parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), gingival     index (GI) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in     gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.   "
3132|NCT03244930|"     Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell     mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely     administered once as a single dose in first attempt leading to apheresis yields of >2 x 106     CD34+ cells/kg body weight.   "
3133|NCT03244917|"     This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data     analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an     intervention to improve infection management for suspected UTIs and LRIs among residents with     advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of     randomization as the intervention must be delivered at the facility level to avoid     contamination and because this is how it would be employed in the real-world. Analyses will     be at the patient level.   "
3134|NCT03244904|"     Participants will be consented into the study after they are found to meet the study     inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the     participant to give NGS(Next-generation Sequencing).One is according to the germline mutation     data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the     extensive consistency detection of blood and tissues in patients with SCLC gene mutation     information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in     patients with SCLC during treatment, by changing the types of mutations / abundance (for     example: the clonal evolution of typical samples analysis) and change of tumor load, ,     investigating the patients treatment effect , for the significant change of mutations, to     study whether it can be used as molecular marker; four is to analyze of the molecular typing     of SCLC, according to the clinical and pathological features of patients.   "
3135|NCT03244891|"     Heart Rate Variability (HRV) analysis has been studied in the critically ill patients     although it is affected by several uncontrolled variables in the clinical conditions. The aim     of this trial is to measure the effects of mildly reduced central volume and cyclic variation     of intrathoracic pressure on the variables frequently used to describe the HRV.   "
3136|NCT03244878|"     This study evaluates a culturally-modified version of Thrive, a computerized Cognitive     Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural     Montanans. Study participants will be randomized to either a wait-list treatment as usual or     the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary     assessment measure is the Patient Health Questionnaire-9.   "
3137|NCT03244865|"     Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal     well-being during labor or preparation for cesarean delivery. Current monitoring methods:     transabdominal ultrasound and fetal scalp electrodes have limitations (tracing loss during     fetal movement, potential to confuse maternal for fetal heart rate, inability to monitor     during cesarean section or abdominal surgery) and, in the latter case, risks (infection,     hematoma). A reliable, non-invasive monitor of the fetal heart rate that can be used during     labor, non-obstetric and obstetric surgery during pregnancy is needed. Recent developments in     use of maternal abdominal electrodes for extraction of the FHR and contraction information     inform this study.      LaborView®, developed by researchers at UF College of Medicine and OBMedical, is an     FDA-approved non-invasive labor monitoring device. Refinement of the extraction algorithms     continues, and that work is most effectively performed at UF, where the primary researchers     and OBMedical are located.      LaborView monitoring will be recorded from 150 subjects admitted to Labor and Delivery at     UFHealth. Data will be simultaneously obtained from the standard labor monitor. These signals     will then be analyzed off-line for comparison and refinement of algorithms.   "
3138|NCT03244852|"     The study aims to improve patient-specific anatomical targeting of the Deep Brain Stimulation     for the treatment of intractable OCD.   "
3154|NCT03244644|"     This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3     study of a microbiota suspension of intestinal microbes. Patients who have had at least two     recurrences after a primary episode and have completed at least two rounds of     standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI     resulting in hospitalization within the last year may be eligible for the study. Subjects who     are deemed failures following the blinded treatment per the pre-specified treatment failure     definition may elect to receive an unblinded RBX2660 enema.   "
3155|NCT03244631|"     Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during     hip arthroscopy   "
3139|NCT03244839|"     The increasing demand of bariatric surgery requires ongoing improvement of the preoperative     and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery     mainly focuses on weight loss, improvement of co-morbidities and quality of life.     Post-operative nutritional deficiencies are a complication of bariatric surgery, in     particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and     D are frequently reported and may occur despite supplementation. Morbid obesity itself is     associated with nutritional deficiencies as well, which become worsening after bariatric     surgery. The occurrence of nutritional deficiencies has been reported in the literature but     not in Taiwan. The goal of the current study is to determine the prevalence and incidence of     nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving     standard supplementation in Taiwan.   "
3140|NCT03244826|"     This research study aims to evaluate the effectiveness of allowing patients who have had a     hematopoietic cell transplant to receive some of their post-transplant care with a local     oncologist rather than returning to the transplant center for all of their follow-up.   "
3142|NCT03244800|"     A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety     and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus.     Approximately 63 subjects will be enrolled across two cohorts.   "
3143|NCT03244787|"     The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC)     screening patient navigator program for patients with Mental Health (MH) and /or Substance     Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study     will involve randomly assigning eligible patients to early intervention or usual care/delayed     intervention groups. The investigators believe this random assignment is ethical because     Patient Navigation (PN) is an extremely limited resource, and all patients identified as     eligible could not be contacted by the navigators in a short period of time. Thus the     investigators will randomly assign access to PN during the study period, and then allow all     patients to be navigated and screened after the study period is over. As a result, all     eligible patients will be referred for PN, but the timing of the referral will be randomly     assigned.   "
3144|NCT03244774|"     In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and     Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with     advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and     launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer.     Therefore, investigators initialize this dose escalation phase I study to explore the safety     of combination of apatinib and POF as first-line treatment for advanced gastric cancer.     Investigators will analyze the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT)     of apatinib in this study.   "
3145|NCT03244761|"     Tracheostomy is often performed in patients after or anticipated prolonged mechanical     ventilation, who are usually required oxygen therapy after discontinuation of mechanical     ventilation.   "
3146|NCT03244748|"     Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in     cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone     after ablation is needed.   "
3147|NCT03244735|"     Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but     carbohydrate restriction. It is followed by millions of people around the word as a     life-style, but in the last years was proposed as a treatment for the epilepsy, by its     capacity to induce the state of ketosis.      Since Authors observed that ketosis could be also useful in migraine, and migraine shares     some pathophysiological features with cluster headache, The aim of the study is to test the     efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.   "
3148|NCT03244722|"     This study attempts to understand the association between maternal weight and child weight.     Intended participants are both obese and lean women looking to get pregnant in the near     future. Obese participants will be randomized to either a structured very low calorie diet or     standard-of-care pre-natal dietary counseling. Lean participants will receive     standard-of-care pre-natal dietary counseling. From pre-pregnancy through one-year after     delivery, both mom and child will participate in tests looking at how their bodies process     and store energy. Our hypothesis is that we affect the maternal-child weight association by     changing the mother's pre-pregnancy metabolic make up.   "
3149|NCT03244709|"     Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been found to have a crucial role in     the pathogenesis of Giant cel arteritis (GCA). Based on this rationale, several recent     studies demonstrated the efficacy of tocilizumab (TCZ), an anti-IL-6 targeted monoclonal     antibody, for the treatment of patients with refractory GCA. Confirming previous reports,in a     recent retrospective study the investigators successfully treated 10 patient with refractory     GCA with TCZ. All patients achieved a complete disease remission evaluated by clinical,     laboratory, and positron emission tomography (PET). In a considerable number of GCA patients     treated with corticosteroids (CS) the therapy may be interrupted with no disease flares. No     data are available on the management of patients achieving the remission with TCZ.   "
3150|NCT03244696|"     The investigators propose to conduct a randomized 6-month intervention study comparing     cognitive functioning in individuals with relapsing-remitting multiple sclerosis assigned to     either a physical activity or an active water-intake control group. Individuals will complete     pre-, mid- and post-assessments of cognitive, physical, and behavioral functioning.   "
3156|NCT03244618|"     Double blind parallel study to measure the efficacy of a toothpaste containing     calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste     containing fluoride   "
3465|NCT03240575|"     The primary objective of the trial is to show superiority in lung function of once daily (2     inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to     twice daily (one inhalation) treatment with fluticasone propionate+salmeterol fixed dose     combination over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD).   "
3158|NCT03244592|"     The objective of this proposal is to advance medication development for alcohol use disorder     by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator,     as a potential treatment. This study has important clinical implications, as the available     treatments for alcohol use disorder are only modestly effective and testing novel medications     is a high research priority.   "
3159|NCT03244579|"     Study is an interventional clinical trial. Pregnant women (aged 25-40 years) diagnosed with     GDM (by a 75-g oral glucose tolerance test at 24-28 weeks' gestation) will be recruited     conveniently from Obstetrics and Gynecology clinic at the Jordan University Hospital and     National Center for Diabetes, Endocrinology and Genetics, Amman, Jordan. A sample of 180     pregnant women with GDM (60 women who do not use insulin and hypoglycemia medications, 60     women who are treated with metformin, 60 women who are treated with insulin), who will meet     the inclusion criteria and will be agreed to participate will be centrally randomized to     follow carbohydrate counting dietary intervention, carbohydrate counting and DASH dietary     intervention, and control dietary intervention.   "
3184|NCT03244254|"     A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac     patients during diagnosis to levels under gluten free diet, it's correlation with traditional     serology testing and questionnaire regarding patient responsiveness to the gluten free diet,     and in comparison to a control group.   "
3422|NCT03241134|"     An experimental study will be conducted to evaluate the effect of a single dry needling     session, compared to a sham needling session, on surface EMG activity (signal amplitude and     frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia.   "
3160|NCT03244566|"     Esophageal cancer is the eighth most common cancer around the world, with more than 450000     new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is     the mainstay of treatment in many countries for patients with esophageal cancer. To improve     the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was starTed in     1980s. More potential positive lymph nodes were found during more extended lymphadenectomy,     offering more accurate TNM staging, affecting consequent treatment.     However，3-field-lymphadenectomy was associated with increased surgical morbidity and     mortality. Positron emission tomography (PET) is used for detecting distant metastases and     lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting     cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and     to determine if we can use PET to guide future cervical lymphadenectomy.   "
3161|NCT03244553|"     This study will test prucalopride (a prokinetic drug currently approved by Health Canada for     treatment of constipation) as a treatment for Ineffective Esophageal Motility (IEM). Adult     patients with previously diagnosed IEM will be invited to participate by the investigators.     The participants will take the study medication for 5 days and on the final day of medication     undergo an esophageal manometry procedure at the Calgary Gut Motility Centre to measure     esophageal function. Symptoms and side effects will be tracked at baseline and on Day 5.   "
3162|NCT03244540|"     All patients will be anaesthetized with spinal technique. Each patient will be treated with     intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will     receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat     postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total     morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery     each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom     Inventory (NPSI).   "
3164|NCT03244514|"     There is no specific therapy for acute kidney injury. It is presumed that supportive measures     improve the care and outcome of patients with acute kidney injury.      We hypothesize that the implementation of a bundle of supportive measures adapted to patients     undergoing cardiovascular surgery reduces the occurence of AKI.      A Randomized prospective multicenter trial is needed to investigate whether the     implementation of the bundle of measures is effective to prevent AKI in high risk patients     undergoing cardiac surgery. In this feasibility trial we will analyze the compliance rate to     the trial protocol in a multicenter, multinational cohort in preparation for a large     randomized controlled trial.   "
3165|NCT03244501|"     The purpose of this study is to see if a new brain stimulation technique, static magnetic     field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp,     can influence normal rhythms of brain activity.   "
3166|NCT03244488|"     It is estimated that by 2016, nearly 50% of HIV-positive individuals in the US will be aged     50 or older, and up to 60% of those will experience some degree of cognitive impairment as     they age. The purpose of this study is to evaluate the contribution of the neuronal     cholinergic receptor system to the cognitive impairments seen in adults aging with chronic     HIV Infection. By using anti-cholinergic challenge drugs to reversibly stress cognitive     functioning, the investigators hope to understand whether the presence of the HIV virus in     the brain impairs the neural system necessary for normal cognition, more than would be     expected from normal cognitive aging.   "
3167|NCT03244475|"     Mild traumatic brain injury (mTBI) is a leading cause of sustained physical, cognitive,     emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However,     the underlying pathophysiology is not completely understood, and there are few effective     treatments for post-concussive symptoms (PCS). In addition, there are substantial overlaps     between PCS and post-traumatic stress disorder (PTSD) symptoms in mTBI. IASIS is among a     class of passive neurofeedback treatments that combine low-intensity pulses for transcranial     electrical stimulation (LIP-tES) with electroencephalography (EEG) monitoring. LIP-tES     techniques have shown promising results in alleviating PCS individuals with TBI. However, the     neural mechanisms underlying the effects of LIP-tES treatment in TBI are unknown, owing to     the dearth of neuroimaging investigations of this therapeutic intervention. Conventional     neuroimaging techniques such as MRI and CT have limited sensitivity in detecting     physiological abnormalities caused by mTBI, or in assessing the efficacy of mTBI treatments.     In acute and chronic phases, CT and MRI are typically negative even in mTBI patients with     persistent PCS. In contrast, evidence is mounting in support of resting-state     magnetoencephalography (rs-MEG) slow-wave source imaging (delta-band, 1-4 Hz) as a marker for     neuronal abnormalities in mTBI. The primary goal of the present application is to use rs-MEG     to identify the neural underpinnings of behavioral changes associated with IASIS treatment in     Veterans with mTBI. Using a double-blind placebo controlled design, the investigators will     study changes in abnormal MEG slow-waves before and after IASIS treatment (relative to a     'sham' treatment group) in Veterans with mTBI. In addition, the investigators will examine     treatment-related changes in PCS, PTSD symptoms, neuropsychological test performances, and     their association with changes in MEG slow-waves. The investigators for the first time will     address a fundamental question about the mechanism of slow-waves in brain injury, namely     whether slow-wave generation in wakefulness is merely a negative consequence of neuronal     injury or if it is a signature of ongoing neuronal rearrangement and healing that occurs at     the site of the injury. Specific Aim 1 will detect the loci of injury in Veterans with mTBI     and assess the mechanisms underlying functional neuroimaging changes related to IASIS     treatment using rs-MEG slow-wave source imaging. The investigators hypothesize that MEG     slow-wave source imaging will show significantly higher sensitivity than conventional MRI in     identifying the loci of injury on a single-subject basis. The investigators also hypothesize     that in wakefulness, slow-wave generation is a signature of ongoing neural rearrangement /     healing, rather than a negative consequence of neuronal injury. Furthermore, the     investigators hypothesize IASIS will ultimately reduce abnormal MEG slow-wave generation in     mTBI by the end of the treatment course, owing to the accomplishment of neural rearrangement     / healing. Specific Aim 2 will examine treatment-related changes in PCS and PTSD symptoms in     Veterans with mTBI. The investigators hypothesize that compared with the sham group, mTBI     Veterans in the IASIS treatment group will show significantly greater decreases in PCS and     PTSD symptoms between baseline and post-treatment assessments. Specific Aim 3 will study the     relationship among IASIS treatment-related changes in rs-MEG slow-wave imaging, PCS, and     neuropsychological measures in Veterans with mTBI. The investigators hypothesize that Reduced     MEG slow-wave generation will correlate with reduced total PCS score, individual PCS scores     (e.g., sleep disturbance, post-traumatic headache, photophobia, and memory problem symptoms),     and improved neuropsychological exam scores between post-IASIS and baseline exams. The     success of the proposed research will for the first time confirm that facilitation of     slow-wave generation in wakefulness leads to significant therapeutic benefits in mTBI,     including an ultimate reduction of abnormal slow-waves accompanied by an improvement in PCS     and cognitive functioning.   "
3168|NCT03244462|"     This study is planned to explore the effect of food on the oral pharmacokinetics, the     intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore,     this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally     administered methotrexate in healthy male subjects.   "
3466|NCT03240562|"     The investigators aimed to assess Ultrasounde- guided serratus anterior plane block is not     inferior with paravertebral block in acute postoperative pain following thoracic surgery.   "
3169|NCT03244449|"     Around the world, the prevalence of type 2 diabetes mellitus (T2DM) has been increasing since     the last two decades, with approximately 347 million patients with diabetes by 2013 according     to the World Health Organization (WHO). This pronounced increase is due to an increase in the     prevalence of obesity, reduction in physical activity levels, accelerated urbanization and     aging of the population. In Colombia, T2DM ranks fifth in the main morbidity and mortality     causes, including only deaths caused directly and without adding the strong influence that     T2DM has on cardiovascular disease mortality.      Insufficient tissue response to normal insulin concentrations, called insulin resistance, is     one of the central pathophysiological mechanisms in the development of T2DM. However, there     is currently no simple, practical, safe and reproducible method that allows the diagnosis or     identification of insulin resistance, nor the follow-up to its evolution. At the moment, the     gold standard for assessing the degree of insulin sensitivity or resistance is the     hyperinsulinemic-euglycemic clamp, a laborious technique, of high cost and high technical     difficulty, requiring specialized personnel and hospitalization. Non-invasive methods based     on mathematical regressions, such as the Homeostatic Model Assessment (HOMA-IR), are     imperfect and widely variable, and have not been validated in the Latin American population,     less Still Colombian.      Therefore, the development of new, easily obtainable quantitative tools for the diagnosis of     insulin resistance is required. This requires not only the identification of new and better     biomarkers, but also the determination of their diagnostic performance and operational     characteristics.      This project will investigate 3 molecular targets (myokines), novel and easy to measure, with     high probability of being good biomarkers of insulin resistance. The research will include     validation of its association with insulin resistance measured by the reference method, as     well as its measurement in apparently healthy individuals. Finally, operator-receiver     characteristics of each test will be analyzed, in order to propose a cutoff point for the     diagnosis of insulin resistance.   "
3170|NCT03244436|"     We study the outcome and prequesties of emergency surgeries that were necessary following     accidents in the pediatric cardiac catheterization lab   "
3171|NCT03244423|"     Pediatric patients suffering cyanotic congenital heart disease (CCHD) are prone to excessive     surgical bleeding in the early postoperative period and the need for transfusion when exposed     to cardiac operations in which cardiopulmonary bypass (CPB) is used. The use of     antifibrinolytic agents such as E-amino caporic acid or tranexamic acid (TX) to reduce blood     loss after Pediatric cardiac surgery has been described in several studies   "
3172|NCT03244410|"     -  immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by          increased platelet destruction and decreased platelet number (cooper N et al 2006)        -  recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial          autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic          forms may represent two distinct immunopathological disorders ( cooper N et al 2006) (          Gern Sheimer T 2009 )   "
3173|NCT03244397|"     OBJECTIVE: To find out the effectiveness of physical therapy for stages I and II pelvic organ     prolapse. DESIGN: Randomized, controlled and single blinded clinical trial. Patients will be     randomly assigned to one of these groups: Experimental group: physical therapy + training in     lifestyle advice; Control group: just training in means of lifestyle advice. In both groups     several physical therapy assessments will be undertaken: 1st before intervention; 2nd     immediately after completing intervention; 3rd, 4th, 5th and 6th after 3, 6, 12 and 24     months. SUBJECTS: Women with previously untreated prolapse of stage I or II (confirmed by     their gynaecologist using the POP-Q) in Príncipe de Asturias Hospital, provided that there is     no contraindication for physical therapy, and after reading, understanding and freely signing     an informed consent form. SAMPLE SIZE: A total of 120 subjects will be included in the study     (60 subjects in each group). DATA ANALYSIS: A descriptive analysis will be done of all the     variables, as well as bivariate analysis in order to find all the possible relationships     between the variables. A confidence level of 95% (p<0.05) will be established for all the     cases. Effectiveness will be evaluated by comparing between the two groups of the change in     outcome variables between visits.   "
3174|NCT03244384|"     This randomized phase III trial studies how well pembrolizumab works in treating patients     with bladder cancer that has spread from where it started to nearby tissue or lymph nodes.     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells     to grow and spread.   "
3175|NCT03244371|"     Spontaneous recovery of patients infected with HCV is related to the development of a     cytotoxic immune response that is executed by specialized white blood cells, the CD8+ T     cells, which develop a virus-specific response. In addition, the natural killer (NK) cells     provide a first-line innate cytotoxic response, which is pivotal for the spontaneous clearing     of HCV. In patients where HCV infection settles chronically, CD8+ T lymphocytes and NK cells     fall into a state of anergy induced by chronic viral challenge. This anergic state is also     found in the case of HIV infection and exacerbated by HIV-HCV coinfection. The first     therapeutic strategies against HCV were based on a treatment with interferon alpha, which had     an antiviral but also immunosuppressive effect. In fact, this therapeutic strategy was unable     to help the recovery of the patient's immune system that would be expected after HCV cure.     However, interferon-free therapeutic strategies combining first generation direct antiviral     agents (DAA) showed a positive effect on HCV antiviral immunity, by enhancing the     proliferative response of CD8+ T cells and the cytotoxic and proinflammatory responses of NK     cells in HCV monoinfected patients (4, 5). Since HCV-targeted therapies based on combinations     of the latest generation of DAA have nearly 100% cure rates and enable faster viral     suppression over shorter treatment times, a positive impact of these regimens on antiviral     immunity is plausible. This possibility would be particularly interesting in HIV-HCV     co-infected patients, where reactivation of the innate antiviral immunity may contribute to     immune defenses against both viruses. Moreover, it has been previously reported a moderate     but significant and sustained decline of HIV-1 DNA in CD4 T cells from HIV-1/hepatitis C     virus-coinfected patients receiving highly active antiretroviral therapy and treated with IFN     alpha/ribavirin.      To date, the real impact on antiviral immunity of treatment as well as on HIV reservoir with     the latest generation of DAA was not measured in HIV-HCV co-infected patients.      The aim of this study is to analyze the impact of the cure of hepatitis C on the HIV DNA     reservoir and antiviral function of CD8+ and NK cells in a subgroup of patients receiving the     latest generation DAAs for treatment of HCV infection, as part of a program for a reduction     of the prevalence of chronic hepatitis C patients co-infected HIV-HCV set up within the     Immuno-Hematology Service of the Sainte Marguerite Hospital (Research in routine care-Ethics     committee Approval Sud- Méditerranée I ID RCB 2015-A01913-46/ Principal Investigator: Dr I     Poizot-Martin).      The analysis of HIV DNA, NK and CD8+ T lymphocyte antiviral immune response prior, during and     after anti-HCV treatment will need the collection of a biobank. Indeed, 25 mL peripheral     blood will be collected at treatment initiation, during an interim assessment, at the end of     treatment and six months post-treatment, for a total of 100 ml of additional blood     collection. These analyzes will be performed by Dr C Tamalet for HIV DNA IHU-Méditerranée     Infection, and the team of Prof. E Vivier, DHU- Marseille Immunopole for NK and CD8+ T     lymphocyte antiviral immune response.   "
3176|NCT03244358|"     To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple     negative breast   "
3177|NCT03244345|"     Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with     epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has     been postulated. Both epilepsy and depression also interact with stressful life events, but     only some patients develop these disorders after a stressful event, indicating the     possibility of a vulnerable population. Animal and human studies have looked at the role of     brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF     are associated with higher incidence of depression, and thus indicate the vulnerable     population.      Animal studies of BDNF have looked specifically at the relation between epilepsy and     depression using a novel double hit design. After chronic stress exposure, measurement of     BDNF levels allowed identification of 2 sub-groups: a vulnerable population and     non-vulnerable population. A second hit of kainic acid induced status epilepticus (SE) was     then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable     population exposed to SE developed a depression-like profile.      In a proof of concept approach we propose studying the relation between epilepsy, depression,     anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant     epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in     150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for     healthy subjects and for depressed subjects without epilepsy, we hope to identify whether     risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels.     In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and     C-reactive protein will be measured in addition to BDNF.   "
3178|NCT03244332|"     Prospective investigations into the role of hemostatic factors in the risk of variceal     bleeding among children with chronic liver disease (thromboelastometry e.g) is still     required. A better understanding of these factors would permit better risk stratification and     targeted prophylaxis or therapy.   "
3213|NCT03243877|"     POC Medical Systems has developed a Point of Care system for the screening of breast cancer     in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to     determine breast cancer's risk level for a subject by identifying the presence in plasma of     known biomarkers. The present study aims to determine the Sensitivity and Specificity of the     test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.   "
3179|NCT03244319|"     1. objectives: The primary aim of ENAVLE is to explore the efficacy of edoxaban in patients          with post mitral valve repair or bioprosthetic valve implantation        2. Primary / Secondary Endpoint      1) Efficacy Endpoint Evaluation: Occurrence of thromboembolic events and any thrombus at     repaired ring or bioprosthetic valves detected by follow up echocardiography or 3D CT scan      2) Safety Endpoint Evaluation        -  Dysfunction of treated valve caused by thrombosis on echocardiography or 3D CT scan        -  Major or minor bleeding described in safety outcomes   "
3180|NCT03244306|"     Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and     some patients who relapse following CD19 directed therapy relapse with CD19 negative     leukemia. For this reason, the investigators are attempting to use T-cells obtained directly     from the patient, which can be genetically modified to express a chimeric antigen receptor     (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell     in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the     leukemic cell through the recognition of CD22, a protein expressed on the surface of the     leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine     the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to     treat patients with CD22+ leukemia.   "
3181|NCT03244293|"     To evaluate the discriminative power of BIS monitoring to classify the degree of mental state     associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the     improvement or deterioration of sepsis.   "
3182|NCT03244280|"     A Study of the Systemic Absorption of Once Daily MOB015B when Applied for 28 Days in Subjects     with Moderate to Severe Onychomycosis of the Toenails.   "
3183|NCT03244267|"     The purpose of this study is to explore the impact of using a smartphone app reminder on     medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as     anti-thrombotic therapy after knee or hip arthroplasty.      This study will randomly assign participants to get usual postoperative care which is     teaching with verbal instructions and printed information about taking the aspirin at the     time of discharge, or to have an app on your smartphone with preset reminders in addition to     usual postoperative discharge teaching after surgery.   "
4599|NCT03225651|"     The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow     mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism     children   "
3185|NCT03244241|"     Hyperglycemia during admission is associated with increased rate of complications and longer     hospital stays, thus insulin treatment is recommended for all diabetes patients with     hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control     with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but     increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin     therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently     than sliding scale insulin, with few episodes of hypoglycemia.   "
3186|NCT03244228|"     Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple     ascending dose trial in healthy younger and elderly adult subjects, with an open-label,     randomised, crossover arms to assess the effect of food on bioavailability.   "
3187|NCT03244215|"     The primarily goal of the research is to better understand progression of disease in patients     who present with an acute stroke to the Hamad General Hospital (HGH) stroke and Transient     Ischemic Attack (TIA) clinic. The investigators are specifically interested in patients who     have diabetes and have a stroke.      The patients enrolled into the research will have detailed clinical evaluation and their     imaging studies (MRI and Doppler) will be reviewed. After informed consent, subjects will be     examined in the stroke Ward /TIA clinic upon recruitment, and later at less than 48 hours of     recruitment (blood extraction and urine samples) and for follow up visits at 1 month+/-7 days     (clinical evaluation and to extract blood and urine samples), at 3 months (telephonic     conversation only) and at 1 year (clinical and repeat MRI brain).      During the initial visit at the ward the investigators will collect serum and plasma for     proteomic and metabolomic studies. These will be repeated at less than 48 hours and at 1     month+/-7 days. Investigators will test the effects of risk factors such as diabetes/stroke     on the endothelial procoagulant and inflammatory state at onset and evaluate if best medical     control leads to improvement in such markers.The repeated studies will determine if better     management and presence of certain blood biomarkers can predict or translate to slower     progression of disease and correlate it with clinical status.   "
3188|NCT03244202|"     Health care providers (HCP) are increasingly using genomic sequencing (GS) to target     treatment for patients. However, GS may incidentally reveal inherited risks for thousands of     current and future diseases. Guidelines recommend HCP inform patients of incidental GS     results. No decision aid (DA) exists to guide patients' decisions about which incidental GS     results they wish to learn. This study will evaluate whether the DA followed by genetic     counselling (GC) reduces decisional conflict compared to GC alone in a randomized controlled     trial (RCT) with 128 patients with a family history of cancer, who have had a negative     genetic test and may eligible for GS. A qualitative component with a subset of participants     (n=40) will explore patients' preferences for the types of incidental results they wish to     receive and their decision making process.   "
3189|NCT03244189|"     A randomized clinical trial to investigate the impact of increased fluid intake and increased     urine output on the recurrence rate of urinary stone disease (USD) in adults and children.     The primary aim of the trial is to determine whether a multi‐component program of behavioral     interventions to increase fluid intake will result in reduced risk of stone disease     progression over a 2‐year period.   "
3190|NCT03244176|"     To evaluate the feasibility of adding induction and maintenance Avelumab to the standard     combination of R-CHOP in patients with stage II, III and IV diffuse large B cell lymphoma     (DLBCL)   "
3191|NCT03244163|"     This study aims to compare the overall rate of endoscopic clearance of complicated bile duct     stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser/electrohydraulic     lithotripsy versus conventional BML.   "
3192|NCT03244150|"     The Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born     between 1964 and 1969. Baseline data originate from two different studies carried out in 1983     and 1985, and the follow-up study was carried out in 2005.   "
3193|NCT03244137|"     Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.      It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive     impairments.      Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional     incapacity. However, it effects on cognitive dysfunction are not well known.      The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation     program on cognitive dysfunction in patients with severe to very severe chronic obstructive     pulmonary disease using the Montreal Cognitive Assessment tool.   "
3194|NCT03244124|"     Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,     that aims to evaluate the best application strategy when using a new Universal Adhesive     system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and     recruited,following inclusion criteria and pre-established exclusion. All volunteers will be     informed and sign a term of clarification and consent. 50 enrolled patients will receive 200     Class V dental restorations, made in four different ways, one from each experimental group,     using the same universal self-etching adhesive system, which is the tested material in this     study. Non-carious cervical lesions will receive the applied adhesive system in 4 different     protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the     adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in     the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity,     will be air-dried during 5 seconds, and activated during 10 seconds with Light Emission Diode     (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during     30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity     will be air-dried, and then, the adhesive will be applied according to the manufacturer's     instructions, as described in group SET; Group ERDry (Etch& Rinse Dry): 37% phosphoric acid     will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50     teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin     dry, and then, the adhesive will be applied according to the manufacturer's instructions, as     described in group SET; Group ERWet (Etch& Rinse Wet): 37% phosphoric acid will be applied     during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This     acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then,     the adhesive will be applied according to the manufacturer's instructions, as described in     group SET. After applying the adhesive, the restorations will be made with composite resin,     and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using     scores. To determine in which group each tooth will be enrolled, the authors will randomize     the teeth.   "
3206|NCT03243968|"     Cardiovascular diseases (CVD) are responsible, throughout the world, for high mortality rates     and cardiovascular morbidity. Endothelial dysfunction is the earliest marker of clinical     atherosclerosis development. Human studies show that endothelial and microvascular     dysfunction are independent predictors of ischemic cardiovascular events and long-term     prognosis. The study´s objective is to evaluate the endothelial and peripheral     microcirculation changes by venous occlusion plethysmography (VOP),     nailfoldvideocapillaroscopy (NVC) and serum biomarkers in patients with myocardial ischemia     detected by scintigraphy and normal coronarography.   "
4614|NCT03225456|"     In this protocol, the investigators propose a randomised controlled trial to explore the     effects of intra-nasal oxytocin administration on appetite regulation. The investigators will     run a cross-over design with 60 healthy adult men.   "
3195|NCT03244111|"     Objective: There have been a wide variety of interventions to assist with cognition and     memory of older adults; however, it is often unclear if the interventions have an impact on     daily life memory performance and goal attainment. The objectives of this study are to     examine: 1) whether an intervention that involves a simple memory tool assists with daily     life memory performance and goal attainment of older adults; and 2) whether the intervention     has a different effect for individuals with healthy cognition versus individuals with mild     cognitive impairment (MCI).      Research Questions: Can a simple memory tool assist with daily life memory performance and     goal attainment for older adults? Does the simple memory tool have a different effect for     individuals with healthy cognition and individuals with MCI? Methods: The study will use a     mixed 2 X 3 design with cognition (healthy, MCI) as the between subjects factor and time     (session 1, 2, 3) as the within-subjects factor. There will be 40 older adults who have     healthy cognition and 20 older adults who have MCI. The study will consist of 3 sessions for     each participant. The sessions will be held once a week and incorporate: a) the Montreal     Cognitive Assessment (MOCA) to determine level of cognition (healthy, MCI); b) the     Prospective and Retrospective Memory Questionnaire (PRMQ) to help determine daily memory     performance; c) a memory recall test for recent daily events to help determine daily memory     performance; d) the goals of the participants using the Goal Attainment Scaling (GAS); and e)     the development of checklists that are tailored to address goals. In between the sessions,     participants will perform the checklists and update the diary with notes of what they want to     remember on a daily basis. The hypotheses are that: 1) memory performance (i.e., measured     with memory recall of daily events and PRMQ), and goal attainment will increase from session     to session; 2) participants with healthy cognition will have better memory performance and     goal attainment than participants with MCI; and 3) participants with healthy cognition will     have greater gains in memory performance and goal attainment than participants with MCI.   "
3196|NCT03244098|"     To improve spinal cord injury (SCI) rehabilitation through stronger informal caregiving, the     proposed study will modify and evaluate a telehealth Transition Assistance Program (TAP) for     informal caregivers of individuals with SCI during the transition from hospital to home. The     TAP was previously developed for stroke caregivers and has been found to decrease caregiver     strain and depression. In the proposed study, the TAP will be modified for SCI and     implemented at a state-of-the-art SCI rehabilitation facility with a very high volume of SCI     treatment and with telehealth technology already in place through which to test the     intervention.   "
3197|NCT03244085|"     This is a nonrandomized, open-label, no-control, dose-escalation Phase 1b trial in 18     patients with chronic HBV infection to determine the safety, preliminary efficacy, and     pharmacokinetics (PK) of QL-007 after administration over 28 days of multiple oral doses in a     fasted state at the following planned dose levels: 200 mg/day (100 mg two times a day (BID)),     400 mg/day (200 mg BID), then 600 mg once daily (QD), with 6 patients for each cohort.   "
3198|NCT03244072|"     Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent     endophthalmitis   "
3199|NCT03244059|"     This is intended to be an initial proof-of-concept study to show feasibility, validate     assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema     patients who have clinically relevant (and quantifiable) autoimmune responses. The primary     goal is to determine effects of belimumab on levels of autoantibodies against glucose     regulated protein 78 (GRP78) among patients with pulmonary emphysema attributable to     cigarette smoking. The investigators hypothesize that belimumab treatment will safely reduce     circulating levels of autoantibodies that are associated with emphysema, and comorbidities of     this lung disease, including atherosclerosis.   "
3200|NCT03244046|"     The aim is to test whether the psychotherapeutic intervention Somatic Experiencing targeting     Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the     outcomes of guided physiotherapy against chronic back pain development.   "
3201|NCT03244033|"     Preventing contextual errors requires heightening clinician responsiveness to clues that     there are contextual factors during the clinical encounter, in real time. These clues, termed     contextual red flags are evident in two sources: the medical record and from patients     directly. An effective intervention would prompt clinicians to determine whether there are     underlying contextual factors that could be addressed in the care plan, averting contextual     error. This desirable process is termed contextual probing.      While clinical decision support (CDS) has been used to provide physicians with timely     biomedical information at the point of care to prevent errors and promote appropriate care,     this technology also affords an opportunity to draw physician attention to both contextual     red flags and contextual factors in order to avert contextual errors. This study assesses the     potential of contextualized CDS to improve contextualization of care through a randomized     controlled intervention trial, with assessment measures of both patient health care outcomes     and averted costs associated with overuse and misuse of medical services. The three     hypotheses are that CDS:        1. Reduces contextual error: CDS tools that inform clinicians of contextual factors and          prompt them to explore contextual red flags should result in a reduction in contextual          error.        2. Improve health care outcomes: Contextualized CDS predicts improved health care outcomes          defined as a partial or full resolution of the contextual red flag (e.g. elevated HgB          A1c) after the index visit.        3. Reduces avoidable health care costs: Contextualized CDS is associated with a reduction          in misuse and overuse of inappropriate or unnecessary medical services.   "
5428|NCT03214822|"     This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs     standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and     urinary biomarkers of oxidative stress in premature infants.   "
3202|NCT03244020|"     Aspirin and low molecular weight heparin (LMWH) are both commonly employed pharmacologic     methods of venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. Data comparing     these two methods of VTE prophylaxis in patients undergoing pelvic/lower extremity     orthopaedic surgery for malignancy are lacking, however, as compared to the data and     guidelines present for VTE chemoprophylaxis after joint arthroplasty and hip fracture     surgery. In this clinical trial, our specific aim is to compare the post operative incidence     of VTE between patients receiving aspirin and LMWH after pelvic/lower extremity orthopaedic     oncology procedures.   "
3203|NCT03244007|"     We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with     idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings     will affect postoperative visual outcome.   "
3204|NCT03243994|"     Aim: To investigate whether patients with pulmonary hypertension have reduced absorption     capacity compared to COPD patients without cor pulmonale potentially due to venous     obstruction in the portal vein system.      The presence of cor pulmonale was determined by echocardiography. The concentration of     D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion     and used as markers of absorption. Furthermore, urine was collected for five hours to     determine the amount of excreted D-xylose.   "
3205|NCT03243981|"     In this exploratory study, we hope to learn if treatment of broadband light with infrared     light can alter the molecular pathways associated with aging. Secondary exploratory objective     is to see if there are any visible effects of this light treatment on human skin.   "
3207|NCT03243955|"     Transcutaneous electrical acupoint stimulation (TEAS) is an emerging technology for     non-invasive neuromodulation that has broad potential implications and warrants further     study. The investigators' clinical experience from the University of California, Los Angeles     (UCLA) Center for East-West Medicine (CEWM) has also demonstrated that TEAS can be used as an     effective self-care tool for patients with chronic illness who do not have the time or     resources for frequent acupuncture treatments. Chronic constipation is the chosen area of     study because of the large population with a substantial impairment in health-related quality     of life and work productivity. The investigators have recently completed a randomized     controlled trial (RCT) demonstrating the benefit of perineal self-acupressure on quality of     life measurements in this population, which supports investigation into other     acupuncture-based self-care interventions. Given these findings, the investigators     hypothesize that home patient-administered TEAS can provide measurable improvements in both     symptom severity and health related quality of life.   "
3208|NCT03243942|"     The fundamental hypothesis of this project is that real-time intracardiac pressures can be     monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound     technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast     echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired     intracardiac pressures measured invasively during cardiac catheterization. This study is     designed to verify that contrast echocardiography using the SHAPE method, already proven in a     canine model and tested in a human pilot study can be used as a surrogate for cardiac     catheterization with sufficient accuracy to allow clinical applicability in humans.   "
3209|NCT03243929|"     The purpose of the Translation of District Sun Safe Policies to Schools study was to test     whether schools need assistance to facilitate the implementation of school district     board-approved sun safety policies by individual elementary schools. The intervention is     expected to produce a change in practices at the school level and to improve the sun safety     behavior of children attending the intervention schools compared to control schools. A group     of 40 school districts in Southern California that adopted board policy 5141.7 for sun safety     provided 118 schools that were randomized to a intervention condition or to an attention     control condition. The primary outcome is change in school-level sun safety practices based     on 10 Centers for Disease Control and Prevention (CDC) categories for policy change (i.e.,     sunscreen use, UV protective clothing, hats, student education, teacher education, provision     of shade, scheduling to avoid peak UV exposure, parent outreach, resource allocation for sun     safety, and an accountability system). This primary outcome was assessed by a survey of the     principal and one teacher at each school (N=118 principals and 113 teachers at pretest).     Parents (N=1770 at pretest) of children attending the schools completed a self-report measure     assessing the secondary outcomes of change in individual-level sun safety behavior of their     elementary school aged children and number of communications received from the school     regarding sun safety. Assessment of principals, teachers and parents occurred at pretest,     just prior to randomization, and at a posttest 20-months after the pretest. One Parent     Teacher Association (PTA) representative per school was contacted to assess PTA involvement     in intervention activities related to sun safety.      The primary hypothesis was stated for the effectiveness of the intervention condition at     increasing school-level sun safety practices consistent with the sun safety policies of the     school districts and read, H1: At follow-up, a greater percentage of schools in the     intervention condition will implement at least one component of the school district sun     safety policy compared to schools randomized to the attention-control condition.   "
3210|NCT03243916|"     Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic     arterial embolization chemotherapy (TACE) is a common method for the treatment of     unresectable of hepatocellular carcinoma.But for patients with > 10cm hepatocellular     carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic     radiotherapy which can track the movement of tumor and monitor the position deviation of     tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination     of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.   "
3211|NCT03243903|"     In this study, QS-M needle-free injector and needle-insulin pen were used as a drug carrier     to control blood glucose in type 2 diabetic patients.The efficacy and safety of QS-M     needle-free injector and needle-insulin pen were evaluated and compared.This is a     needle-insulin pen as control group, using a prospective, multicenter, randomized, open,     parallel grouping study.   "
3212|NCT03243890|"     Aortic stenosis is a common heart valve disease and due to the growing elderly population the     prevalence is increasing. The disease is progressive with increasing calcification of the     valve cusps. A few attempts with medical preventive treatment have failed, thus presently the     only effective treatment of aortic stenosis is surgery. This study will examine the effect of     menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). The     investigators hypothesize that MK-7 supplementation will slow down the calcification process.   "
3214|NCT03243864|"     The study's primary objective is to determine plasma and dialysis fluid concentrations in     patients prescribed ceftazidime-avibactam as the standard treatment for their infection and     requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment     for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics     of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the     prescribed dose meets pharmacodynamic targets.   "
3215|NCT03243851|"     A phase 2 clinical trial for the efficacy and safety of low dose Temozolomide plus metformin     as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with     recurrent or refractory Glioblastoma   "
3216|NCT03243838|"     Triple-negative breast cancer (TNBC) is a special type of breast cancer, endocrine therapy     and targeted therapy are completely ineffective, chemotherapy is currently the only effective     treatment. How to improve postoperative pathologic complete response（pCR）of neoadjuvant     chemotherapy is critical problem to prolong overall survival (OS) of TNBC patients. Apatinib     is a new oral small molecule tyrosine protease inhibitor, it is effective in inhibiting     angiogenesis with a very low concentration. So the standard neoadjuvant chemotherapy regimen     of docetaxel and carboplatin combined with apatinib may improve the postoperative PCR and OS     of TNBC patients. Safety and tolerability assessed by number of grade 3 and 4 toxicities and     hospitalizations.   "
3217|NCT03243825|"     For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical     hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent     chemo-radiotherapy is necessary if the patients have high-risk factors, including positive     surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that     combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of     post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.   "
4424|NCT03227926|"     Open label, single-arm, multiple centers, Phase II trial. The trial has been designed to     prove or disprove whether a third line rechallenge with panitumumab can achieve an objective     response rate (ORR= CR+PR) of 30% or more in a population of RAS wild type mCRC patients     selected on the basis of RAS extended clonal evolution in their plasma.   "
3218|NCT03243812|"     Background : Sickle cell patients have profound remodeling of their muscle microcirculation     networks with signs of amyotrophy. However, the consequences of these muscle alterations on     the functional status of muscles are unknown. In addition, whether the poor physical fitness     of sickle cell patients can be attributed, at least partly, to an hypothetical muscle     dysfunction has never been tested.      Purpose : this study will compare the muscle function of legs between sickle cell patients     (SS and SC genotypes) and healthy individuals (AA genotype) before, during and after a short     localized muscle endurance exercise.      Abstract : Very recently, a study reported large differences between the muscle     microcirculation networks of sickle cell patients compared to healthy individuals with     decreased capillary density and higher proportion of large capillaries in the former     population. In addition, the same study showed signs of amyotrophy in sickle cell patients.     However, the muscle function of sickle cell patients has not been investigated and one may     suggest that muscle dysfunction could participate in the decrease of physical fitness, in     association with the hematological and hemorheological disorders, already reported in this     population. The hypothesis is that muscle fatigue during a short localized muscle endurance     exercise should be higher in sickle cell patients compared to healthy individuals, due to a     greater recruitment of glycolytic fibers and a faster decrease of muscle oxygenation during     exercise.   "
3219|NCT03243799|"     The primary aim is to evaluate the effectiveness of an intervention based on a     psychoeducational program carried out by primary care nurses, to improve the rate of     remission and response of depression in patients with physical chronic illness (diabetes,     COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness     of the intervention, the effectiveness to improve the control of physical pathology, the     impact on quality of life and the feasibility of the intervention.      Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up     evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over     50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural)     with major depression and with at least one of the diseases: diabetes mellitus type 2,     chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be     distributed randomly into two groups. The intervention group will participate in     psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting     of health education on chronic physical illness and depressive symptoms.      Main measurements: clinical remission of depression and / or response to intervention (Beck     depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease     (blood test and physical parameters), drug compliance (test Morinsky-Green and number of     packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital     admissions due to complications) and feasibility of the intervention (satisfaction and     compliance). Evaluations will be masked and conducted at 0, 3, 6 and 12 months.   "
3220|NCT03243786|"     The purpose of this study is to examine the impact of a lifestyle intervention. The study     will examine the Stay on Track program, dietary and activity patterns, body composition,     biomarkers and quality of life in breast cancer patients undergoing radiation therapy.   "
3221|NCT03243773|"     Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment.     However, the differentiation between heart failure and other conditions presenting with acute     dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a     simple, rapid and noninvasive technique directly visualizing fluid content in the lung as     evidence for acute heart failure. A number of publications showed the diagnostic utility of     lung ultrasound in the diagnosis of heart failure, but many open questions remain.      The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a     cardiac origin of dyspnea in unselected patients in the emergency room as compared to     standard evaluation. Further goals are to evaluate if lung ultrasound provides additional     diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to     compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart     failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart     failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary     disease) and to compare demographics and clinical characteristics in different patient     populations.      300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as     principal complaint will undergo initial clinical assessment of the likely etiology of     dyspnea by the ER physician in charge. The second assessment by the same physician will     include results of NT-proBNP according to predefined cutoffs. Final diagnosis (Gold     Standard) will be done by two experienced investigators after patient discharge taking into     account the complete medical record except the results of lung ultrasound. Assessment of     chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all     other results.   "
3261|NCT03243253|"     In this cross sectional study, county level data for CVD and stroke mortality, and prevalence     of T2D, were combined with per capita densities of FFR and FSR and analysed using multiple     and simple linear regression. Mortality and diabetes prevalence were corrected for poverty,     ethnicity, education, physical inactivity and smoking to reduce confounding effects.   "
3222|NCT03243760|"     This study will be the first administration of CCI15106 capsules for inhalation to humans.     The primary objective of the study is to investigate the safety and tolerability of single     and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate     chronic obstructive pulmonary disease (COPD). The intention of this study is to provide     sufficient confidence in the safety of the molecule delivered by inhalation to inform     progression to further repeat dose and proof of concept studies.      This will be a three-part study. Part 1 will investigate single ascending doses and Part 2     repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to     patients with moderate COPD.      There will be screening period of up to 30 days. The treatment period will be 3 days for     Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the     last dose.   "
3223|NCT03243747|"     Preanesthetic evaluation is a clinical assessment process with purpose of increased patient     safety. One focus is review of patient medical history to reduce perioperative morbidity and     mortality as well as optimize the daily process in at anesthesia ambulance. The aim of that     study is the development and implementation of a practical computer-based individualized and     risk-adapted questionnaire for the daily routine   "
3224|NCT03243734|"     Prospective, open label, non-controlled single arm, multi-center study The primary objective     is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of     subjects who have been diagnosed with persistent local esophageal cancer and who are not     surgical candidates or have completed or declined systemic therapy.   "
4841|NCT03222505|"     The goal of this research study was to examine the immediate effects of a prototype wearable     robotic stride management assist device (SMA) designed by Honda R&D® on clinical walking     performance, walking energetics, gait kinematics and corticospinal excitability in     individuals with stroke.   "
3225|NCT03243721|"     This evaluation will be a one-year feasibility study to characterize the neuroprotective     benefits of Gilenya and its effects on cognition and grey matter volumes. The study will     enroll 15 patients with relapsing-remitting multiple sclerosis being treated with Gilenya and     5 healthy controls. Each participant will undergo a battery of neurometric testing at     baseline, six months, and one year. In addition, patients will undergo high-field 7T MRI at     the same time points.   "
3226|NCT03243708|"     Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality.     Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it     increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE     prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of     bleeding. However, identifying patients at low risk for VTE can be difficult, because most     patients have at least one risk factor for VTE and there are no validated risk prediction     tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all     approach with near-universal prophylaxis, putting many patients at unnecessary risk of     bleeding. However, to provide care that is truly patient-centered, US physicians face several     challenges. First, there is no accepted risk calculator that they can use to estimate an     individual patient's risk. Second, risk calculators are not readily available at the point of     care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while     in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also     high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an     individual patient's risk of VTE. The tool is incorporated into the electronic health record     in the form of a smart order set. In this randomized trial, we will assess the effects of the     order set on physician behavior and patient outcomes . Examining the effectiveness of an     electronic decision aid embedded in an EHR in routine clinical practice will test whether a     smart order set can improve patient care by incorporating patient-specific factors into a     complex decision process.   "
3227|NCT03243695|"     patients with fractured teeth in the esthetic area requiring immediate restoration will be     recruited to the study. Immediate implants will be placed and patients will be restored     either with straight or angled abutments. Implant failure will be measured.   "
3228|NCT03243682|"     compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating     bidirectional approach versus the standard approach.   "
3229|NCT03243669|"     Over the last years a number of new endoscopic imaging modalities have been introduced     (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new     imaging techniques, the investigators aimed to investigate their use for the detection of     polyps during colonoscopy.   "
3230|NCT03243656|"     Aplastic anemia is a rare disorder characterized by pancytopenia and a hypo cellular bone     marrow.but,It is very serious disease causing morbidity and mortality.      Aplastic anemia can be treated effectively with haematopoietic stem cell transplantation and     immunosuppressive drug regimens but haematopoietic stem cell transplantation has limitations     due to its cost and many patient are unsuitable. Immunosuppressive drug has a significant     number of patients have persistent cytopenias. Currently, the treatment of these patients is     regular transfusion, which are expensive, inconvenient, and associated with serious side     effects related to iron overload and transfusion.      Eltrombopag is an oral thrombopoietin mimetic that selectively binds at the transmembrane and     juxtamembrane domains of the thrombopoietin receptor, at sites distinct from the binding site     of thrombopoietin therefore it does not compete for binding with the native molecule. It     promoting thrombopoiesis and release of platelets from mature megakaryocytes. Also, promote     other hematopoietic stem cell as well as in thrombopoiesis .   "
3231|NCT03243643|"     To investigate tolerability, safety, pharmacokinetics and efficacy of C-met Kinase Inhibitor     HS-10241 single agent or combined with Apatinib in Subjects With Advanced Solid Tumours that     are not eligible for conventional or intensive treatment. The dose of HS-10241 will be     escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD)     of HS-10241 single agent and in combination with Apatinib in advanced cancer patients. At the     same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 or combined     with Apatinb will be observed in advanced cancer patients. To determine the recommended     dosage regimen for phase II.   "
3232|NCT03243630|"     To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit     flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be     administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be     administered intravenously. The reinforcing drug effects will be measured with the drug     effects questionnaire (DEQ).   "
3233|NCT03243617|"     The purpose of this study is to demonstrate the safety, tolerability and efficacy of AO+ Mist     administered daily for 4 weeks to improve the appearance of skin afflicted with keratosis     pilaris.   "
3234|NCT03243604|"     Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective     small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.      CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as     hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated     with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other     androgen-deprivation therapies are not associated with increased mineral corticosteroid     level.      This study investigates reports of cardiovascular toxicities for treatment including L02 (sex     hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate     cancer in the French pharmacovigilance database and in the EudraCT database.   "
3329|NCT03242356|"     Current French guidelines allow oral intake of clear fluid in women in established labor     under epidural analgesia. To date, no study assessed how these guidelines are followed in     clinical practice. This study aims to assess the current practices as to the fasting during     the labor at our institution, while assessing the experience and the expectations of the     parturients (level of comfort or discomfort related to fasting).   "
3330|NCT03242343|"     This is a prospective clinical study of the VasQ external support for arteriovenous fistulas.     The device is designed to improve fistula outcomes by optimizing the geometrical     configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote     laminar flow.      All patients will be implanted with the VasQ device and will be followed up for a duration of     24 months.   "
3235|NCT03243591|"     Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing     the risk of loss of bone support. The purpose of this study is to evaluate the impact of     brushing the bacterial biofilm at the implant-mucosa interface with one of two,     commercially-available dental gels over a 30-day period on amounts of biofilm and indices of     mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have     at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater,     no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens     disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic     antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel     group will be instructed to apply a pea size amount of dentifrice brushing the implant and     mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to     record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and     adverse events.   "
3236|NCT03243578|"     The aim of the current study was to clarify the relationship between protein intake and     health by using a very large, general population cohort study, UK Biobank, to study the     associations between reported protein intake (expressed in g/day, g/kg/day and % of total     energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).   "
3237|NCT03243565|"     Clinical research question: Can OM-85 reduce the recurrence of respiratory tract infections     (RTIs) in children with AH by stimulating the immunological response of the host and     therefore, as a consequence reduce the size of adenoid tissue in children with adenoid     hypertrophy? Can this prevent further complications such as surgery need? Half of     participants will receive OM-85, while other half will receive a placebo.   "
3238|NCT03243552|"     This project will use the experimental medicine approach of a Phase IIa Proof of Mechanism     16-week, randomized, double-blind, controlled trial of L-DOPA versus placebo administration     in combination with a 16 week social skills training group in order to: 1) identify     differences in social reward processes in adolescent and young adult ASD participants versus     healthy controls as measured by fMRI activation in reward circuitry; 2) provide evidence of     dopaminergic moderating effects on social reward components in ASD with greater pre- to     post-treatment changes expected in the subjects randomized to L-DOPA versus placebo; 3)     examine the hypothesis that baseline readouts of putative dopamine signaling (wanting     activation responses) will predict the extent of fMRI reward-related activation changes pre-     to post-treatment; and, 4) examine the proposed relationship between pre- to post- L-DOPA     fMRI reward changes and changes in individual self-report ratings of social wanting and     ratings of videotaped positive affect in a structured interaction with an examiner. The study     will enroll 56 participants with DSM-5 ASD between the ages of 13-30 years of age and 18     healthy control participants without histories of psychopathology for baseline comparisons.   "
3239|NCT03243539|"     Patients who experience lung injury are often placed on a ventilator to help them heal;     however, if the ventilator volume settings are too high, it can cause additional lung injury.     It is proven that using lower ventilator volume settings improves outcomes. In patients with     acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide     in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes     and higher breathing rates are sometimes required to maintain a normal partial pressure of     carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent     additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both     important for patients with acute brain injury. The investigators have designed a     computerized ventilator protocol in iCentra that matches the current standard of care for     mechanical ventilation of patients with acute brain injury by targeting a normal partial     pressure of carbon dioxide with the lowest ventilator volume required.      This is a quality improvement study with the purpose of observing and measuring the effects     of implementation of a standard of care mechanical ventilation protocol for patients with     acute brain injury in the iCentra electronic medical record system at Intermountain Medical     Center. We hypothesize that implementation of a standardized neuro lung protective     ventilation protocol will be feasible, will achieve a target normal partial pressure of     carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight,     and will improve outcomes.   "
3240|NCT03243526|"     the aim in this study to assess the effect of fluid management in patient undergoing     orthotopic liver transplantation either by using pulse pressure variation or by central     venous pressure. we will assess the impact of fluid management by either methods on     oxygenation and extra vascular lung water visualized by lung ultrasound.   "
3241|NCT03243513|"     The aim of the project is to identify an efficient and effective policy or procedure for     identifying complications from surgical abortions through follow-up phone calls.   "
3277|NCT03243045|"     It has been proposed that the modulation of the activity of the sympathetic nervous system,     through renal sympathetic denervation, besides reducing blood pressure, would promote an     improvement in vascular reactivity and consequent improvement of macro and microcirculation.      The present study aimed to investigate the influence of the renal sympathetic denervation on     the skin microvascular function of patients presenting with resistant arterial hypertension.   "
3278|NCT03243032|"     To determine the clinical effectiveness of combined use of pre-emptive analgesia and long     acting anesthesia for pain suppression following dental implant surgery as measured by a     validated numerical rating scale and the information related to consumption of post-operative     medications.   "
5429|NCT03214809|"     Study to assess the possible effects of the use of a point-of-care thoracic ultrasound     protocol for hospital medical emergency teams (MET)   "
3331|NCT03242330|"     The objective of this trial is to find out if there is a difference between single-piece and     two-piece titanium patient-specific mandibular subperiosteal implants in terms of implant     survival, patient satisfaction, and soft tissue dehiscence. This is to enhance both surgical     and prosthetic outcomes for the sake of improved implant longevity, soft tissue health and     patient well-being.   "
3332|NCT03242317|"     The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the     improvement of near vision in presbyopes treated with low dose, short duration Mitomycin C     (MMC) during surgery and an extended low dose steroid regimen after surgery.   "
3242|NCT03243500|"     There are several local anesthetic techniques available for cataract surgery and the choice     depends on patient, surgical and operator factors. The eyes of patients with axial myopia     (the eye globe is abnormally elongated) have thin wall (sclera), limited space for needle     insertion for local anesthetic injection between the globe and the orbit and out-pouching of     the back of the eye (staphyloma). These factors increased the risk of perforation following     conventional needle techniques of eye block The current study technique is per-caruncular     injection (the needle insertion site is between the nasal side of the globe and bony orbit)     which may provide a safer alternative to the conventional needle techniques for myopic     patients. The space of injection is devoid of blood vessels moreover, myopic staphylomata are     infrequently located on the nasal side of the globe.      Local injection of muscle relaxant added to local anesthetic solution may provide earlier     onset of eye muscle paralysis thus earlier onset of favorable surgical condition than local     anesthetic solution alone.      The current study will demonstrate the effect of adding low dose atracurium (a muscle     relaxant) to local anesthetic mixture in providing early onset of eye muscle paralysis and     favorable surgical condition in per-caruncular technique of eye block in high myopes     undergoing cataract surgery.   "
3243|NCT03243487|"     The study is a prospective, randomized, controlled trial studying adherence to positive     airway pressure therapy in a population referred to the VA system for the treatment of sleep     disordered breathing. The primary aim of the study is to determine if, compared to standard     care provided at a VA Sleep Center, the deployment of a structured adherence management     program and a web-based information program designed for participants beginning positive     airway pressure therapy results in a greater portion of participants meeting Centers for     Medicare & Medicaid Services (CMS) adherence requirements (use > 4 hours for >= 70% of days)     at 90 days.   "
3244|NCT03243474|"     The aim of this project is to recognize the actual frequency of atrial fibrillation in the     Polish population as well as to determine the independent risk factors for the occurrence of     its clinically symptomatic and asymptomatic forms   "
3245|NCT03243461|"     The HIT-HGG-2013 trial offers an innovative high-quality diagnostics and science program for     children and adolescents >3 years, suffering from one of the following types of high grade     gliomas:        1. glioblastoma WHO grade IV (GBM)        2. diffuse midlineglioma histone 3 K27M mutated WHO grade IV (DMG)        3. anaplastic astrocytoma WHO grade III (AA)        4. diffuse intrinsic pontine glioma (DIPG)        5. gliomatosis cerebri (GC) For 1.-3. diagnosis has to be confirmed by neuropathological          survey, for 4. and 5. diagnosis has to be confirmed by neuroradiological survey.      In addition to standard treatment (radiotherapy and temozolomide chemotherapy) the effects of     two further drugs, which have been applied to millions of children and adolescents in other     indications, will be compared to each other. The aim of the trial will be to investigate     whether these drugs may increase the effects of radio- and chemotherapy, resulting in a     better survival of the treated patients. One of these additional drugs will be valproic acid,     traditionally used for treatment of seizure disorder. The other drug will be Chloroquin, a     well-established drug for Malaria treatment. Recently, scientific studies provided evidence     for anti-tumoral effects of both drugs: Valproat seems to be a so-called histondeacetylase     inhibitor (HDAC inhibitor), controlling important genetic processes of tumor growth.     Chloroquin is an autophagy inhibitor. It prevents the shutting-down of tumor cell metabolism,     a strategy to ensure survival of the whole tumor by developing a resistance against radiation     and antineoplastic agents.      Studies in cell culture, animals and first clinical trials in adults as well provided     evidence for efficacy of valproic acid and chloroquine in the treatment of glioblastoma. Due     to this we hope children and adolescents suffering from GBM, DMG, AA, DIPG und GC will     benefit from the treatment, too. As common for clinical trials, the treatment of the patients     will be settled in a randomized manner to ensure impartiality of the investigators.      One aim of the HIT-HGG-2013 trial will be to compare the effects of Valproat and Chloroquin     to each other. Additionally, the results will be compared with data of the HIT-HGG-2007 trial     (children and adolescents with same diseases, only treated with simultaneous temozolomide     radiochemotherapy).   "
3246|NCT03243448|"     There are many sympathetic hyperactivity diseases in the investigators' clinical practice.     However, the conventional method to measure the sympathetic nerve activity had many     limitations such as clinical application, data interpretation and even therapeutic     manipulation. Therefore the investigators would like to develop a non-invasive method to     record the sympathetic nerve activity in the investigators' study that can help gathering the     sympathetic nerve activity easily in the investigators' daily clinical situation. By the     determination of sympathetic nerve activity status, the health caregiver can understand the     disease more.   "
3247|NCT03243435|"     In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for     sentinel lymph node detection. In this follow up study we want to investigate how much of     this tracer is still detectable.   "
3248|NCT03243422|"     The ACHIEVE study will be a randomized controlled trial nested within the Atherosclerosis     Risk in Communities (ARIC) study. 850 70-84 year-old cognitively normal older adults with     hearing loss will be randomized 1:1 to the hearing intervention (hearing needs assessment,     fitting of hearing devices, education/counseling) or successful aging intervention     (individual sessions with a health educator covering healthy aging topics). Post baseline,     participants will be followed semi-annually for 3 years.   "
3249|NCT03243409|"     Retrospective observational study of reversed shoulder arthroplasties by proximal humeral     fracture. Analysis of preoperative risk factors as well as minor and major complications at     the first week, 90 days and 1 year.   "
3250|NCT03243396|"     The study will take place in Kanduyi, a sub-county in southern Kenya, and focuses on children     orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low-     and middle-income countries are at high risk of post-traumatic stress, but mental health     professionals are largely unavailable in this area.      Research suggests that some mental health treatments can be delivered effectively in low- and     middle-income countries using a task sharing approach, in which lay counselors with little or     no prior mental health experience are trained to provide treatment.      Whetten and Dorsey's past studies have suggested that partnering with two government sectors,     education and health, could be a low-cost and sustainable strategy to implement task sharing     mental health services. By training teachers (via the education sector) and community health     volunteers (via the health sector) to provide mental health care, a larger population could     potentially be reached.      Before programs are scaled-up country-wide, it's important to know not only what policies to     implement but also their predicted implementation success and intervention effectiveness.     This study aims to identify implementation strategies and examine whether the education     and/or health sectors are productive partners in scaling up task sharing mental health care     in future programs.   "
3279|NCT03243019|"     To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in     pediatric patients. Rapamycin is administered oral for a 6 month period.      The success rate is determined by volume reduction superior to 1/5e of the initial volume     measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.   "
3251|NCT03243383|"     Post-discharge hospital utilization, i.e., readmissions within 30 days of discharge (30d     readmissions) and emergency department (ED) visits, are a high-priority quality measure and     target for cost reduction. Patients with diabetes are disproportionately over-represented in     30d readmissions, especially among racial minorities and urban populations. We have developed     and validated a tool, the Diabetes Early Readmission Risk Indicator (DERRI), to predict 30d     readmission risk among diabetes patients, which is a critical prerequisite for targeting     limited resources for reducing readmission risk to those most in need. Currently, there are     no proven interventions to reduce the risk of 30d readmission specifically among patients     with diabetes. This proposal will assess the feasibility and acceptability of a novel,     multifactorial intervention, the Diabetes Transition of Hospital Care Program (DiaTOHC),     designed to reduce post-discharge hospital utilization rates in a pilot randomized controlled     trial. The intervention will include inpatient diabetes and discharge education,     comprehensive discharge planning and coordination of care, A1c-based adjustment of diabetes     therapy, and post-discharge support. Hospitalized patients with diabetes identified as high     risk for readmission based on the DERRI will be randomized to the intervention or the control     group, which will receive usual care. Such work is highly relevant in the current era of     soaring health care costs and national health care reform.   "
3252|NCT03243370|"     This study concerns the validation of a clinical test that aims to reveal first level     emotional disorders in neurological diseases.      In order to bring to light such disorders, it is necessary to begin by establishing reference     values in healthy individuals. This test is based on the priming effect and time estimations.     The test procedure has two successive phases. The first phase aims to determine the judgement     of time inherent to each participant and then to assess whether or not this judgement varies     during the second phase with the introduction of emotional priming. First, we set out to look     for and to calibrate video stimuli able to activate emotions. To this end, we used a battery     of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined     their degree of physiological activation by measuring the electrodermal response at the     laboratory for the exploration of the nervous system in Dijon. These measurements also     allowed us to define and refine our paradigm, notably by deciding at what moment the time     estimation task should be done and by eliminating the influence of attention. We decided to     select only seven video sequences because we noticed a reduction in the measurement effect on     time estimations due to habituation of the subject. We also conducted pre-tests in a control     population made up of twenty men and women aged from 20 to 60 years.      This brought to light a warp in time estimation opposite to that we found using olfactory     stimuli. This first finding suggests that there are two types of emotion, one which is     anticipative and the other immediately experienced.   "
3253|NCT03243357|"     In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would     be that the choose of this system based on the anatomical characteristics of the canal and     the biological precepts. In teeth with lesions, contaminated dentin should be removed.     However, in many systems, the manufacturer's approach disregards the fact that in wider root     canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch     the walls at the final apical. Therefore, the establishment of the initial apical file (LAI),     the first instrument that measures the resistance of the walls in working length, could be a     criterion in the choice of which system to use, and how many files work within the root     canals after LAI determination. However, there is a lack of studies that demonstrate that LAI     determination affects the degree of cleaning achieved, as well as the impact that LAI-based     instrumentation may have on microcracks formation, canal transportation, postoperative pain     and quality of obturation.In this way, the investigators propose a study in vivo performed,     in patients from 8 to 18 years of age, therefore in large root canals. The protocol     recommended by the manufacturer will be compared by means of a prospective randomized     clinical trial, with the addition of the XP Endo finisher and with the protocol based on the     initial apical file evaluating postoperative pain, exacerbation between the sessions, the     quality of the obturation and periapical radiolucency repair. Considering that currently     performing endodontic treatments using mechanized instruments is taught in undergraduate     courses throughout the country, studies of this nature help the execution of a endodontics     more critical and effective.   "
3254|NCT03243344|"     This study evaluates the efficiency and the cost of three medical devices and the abstention     of the use of specific product for the post-operative haemostasis in endonasal surgery .   "
3255|NCT03243331|"     Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment     of triple negative breast cancer   "
3256|NCT03243318|"     Stroke is the third common cause of adult disability in dveloped countries. Early     identification of the potential for motor recovery is important to avoid 'learned disuse' and     to initiate appropriate therapy with achievable goals. The current cohort study focuses on     those patients with SAFE <8 and using motor evoked potentials (MEPs) to improve on     prognostication of upper limb motor recovery among subacute stroke patients in a local stroke     population.   "
3257|NCT03243305|"     This is a single-arm, open-label, Phase III study in approximately 100 sites in the United     States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of     pregnancy.   "
3258|NCT03243292|"     To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years     follow-up or beyond in subjects previously enrolled in any of the following Boston     Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.   "
3259|NCT03243279|"     The purpose of this study is to determine whether baroreceptor sensitivity (the ability of     your body to change your heart rate and/or blood pressure in response to a situation) has any     effect on how likely you are to suffer certain events after heart or lung surgery. The     postoperative events that the investigators will be studying are pain after surgery, atrial     fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental     abilities).   "
3260|NCT03243266|"     Results from this study will be used to verify that the published pediatric reference     intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.   "
3280|NCT03243006|"     introduction:Pain remains one of the most common reasons of emergency department admission.      objective: assessing the impact of ealy pain pain management on the use of level II and III     analgesicsand on patient satisfaction.   "
3262|NCT03243240|"     Gastrointestinal bleeding represents a serious clinical problem and a common cause of     hospitalisation with a mortality rate of 6-10% for upper Gastrointestinal bleeding and of 4%     for lower Gastrointestinal bleeding requires a multidisciplinary approach involving     gastroenterologists, endoscopists, surgeons and radiologists.      Gastrointestinal bleeding is self-limited in 80% of cases requiring only supportive measures.     However, the persistence of bleeding represents a diagnostic challenge to locate the site of     bleeding especially in severe bleeding and to determine, if possible its cause. This will     allow to select the most appropriate therapeutic approach in order to reduce the morbidity     and mortality, the length of hospitalisation and the transfusion requirements.      Current diagnostic algorithms vary widely from institution to institution and from clinician     to clinician. Imaging modalities remain the mainstay of the diagnostic approach. They include     endoscopy, video capsule, radionuclide imaging, catheter angiography and multidetector     computed tomography imaging.      In recent years, Multidetector computed tomography has emerged as a promising technology to     evaluate Gastrointestinal bleeding. The modality's ease of use and rapid results favour its     use in any emergent situation. In addition, today's high-speed, narrow collimation     multi-detector technology allows a large coverage area with minimal motion artifacts, with     the ability to capture both arterial and venous phase with ease. Multidetector computed     tomography is being increasingly used as this is a widely available, non-invasive and fast     diagnostic technique that allows for visualisation of the entire intestinal tract and its     lesions, the identification of vascularity and possible vascular abnormalities.   "
3263|NCT03243227|"     Carpal tunnel syndrome CTS is the most common peripheral neuropathy seen in clinic. It     results in marked functional limitations of patients. Most patients undergo surgical release     which places a heavy burden on health system. Neurodynamic exercise is claimed to be an     effective physiotherapy treatment for these patients. It is a practical and     complications-free treatment which can be used as a home exercise program. This study aims to     investigate the effect of median nerve gliding exercise on symptoms severity and functional     limitation in CTS patients.   "
3264|NCT03243214|"     Parkinson's disease (PD) affects more than 100,000 Canadians and results in symptoms     affecting both motor and cognitive (thinking and memory) functions. Parkinson's disease with     Mild Cognitive Impairment (MCI) frequently results in development of dementia for which few     treatment options exist. Transcranial Magnetic Stimulation (TMS) is used to alter activity in     the outer regions of the brain and has been shown in previous studies to increase cognitive     performance in patients with different disorders. This study will investigate the     effectiveness of TMS as a clinical treatment for the cognitive deficits associated with     Parkinson's disease. 64 male and female participants between the ages of 50 and 90 will     attend eight study visits over a period of 63 to 66 days. This study is a double-blind     randomized clinical trial meaning the participant will be assigned by chance to either the     TMS-treatment group or the Sham-treatment group. Additionally, a combination of memory and     thinking tests and Magnetic Resonance Imaging (MRI) will be used to see if there are     structural and functional changes within the brain. Genotyping and blood analysis before and     after treatment for different biomarkers will also be performed and these data will be     compared to the TMS data. Initially, this research will increase knowledge about the effects     of TMS on various brain regions. Ultimately, we will be able to determine if TMS can be used     as a complementary therapy for PD to improve cognitive performance and to reduce progression     into dementia.   "
3265|NCT03243201|"     Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden.     Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely     contributor to recalcitrant disease. Emerging evidence shows that colloidal silver     nanoparticles may be effective for reducing biofilms. The investigators intend to perform a     randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness     and safety of intranasal colloidal silver nanoparticles in adult patients with chronic     rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with     intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement     in symptom scores and will not be associated with increased rate of adverse effects.   "
3266|NCT03243188|"     Study Title: Palliative care in general practice: cancer patients' and carers' experience of     their GP's role      Study Design: Qualitative interview study      Study Participants: Adult patients with cancer and palliative care needs, accompanied by     their carers      Planned Sample Size: Up to 30 interviews with patients +/- their carers      Planned Study Period: October 2017 - December 2018      Research Question: What experience do adults with cancer, and carers, have of their GP's     involvement in palliative care provision?   "
3267|NCT03243175|"     Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant     drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation     (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH).     Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular     non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an     intracerebral haemorrhage.      Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should     start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid     anticoagulation and LAAC.   "
3268|NCT03243162|"     The overall objective of this study is to conduct a two-group randomized trial to examine the     efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function,     return to sport, and quality of life outcomes in patients following ACL reconstruction     (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral     based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central     hypothesis is that the CBPT-ACLR participants relative to the Education group will     demonstrate significantly greater improvement in postoperative outcomes at 12 months     following surgery.   "
3294|NCT03242824|"     This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast     enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with     target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.   "
4925|NCT03221400|"     Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study     evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed     after treatment with previous anticancer therapies.   "
3269|NCT03243149|"     PTSD is a debilitating and costly condition and currently available treatment options have     risks and limitations that necessitate development of novel interventions. Collectively, the     functional brain imaging reports suggest that patients with PTSD, especially those with the     re-experiencing and hypervigilence phenotype, show ventromedial PFC hypoactivation and     amygdala hyperactivation in response to symptom provocation, and that treatment, when     successful is associated with reduced amygdala and increased ventromedial PFC activation.     This project is guided by a neurocircuit model of PTSD dysfunction in which abnormalities in     fronto-limbic imbalance, which diminishes capacity for fear extinction learning, and produces     PTSD symptoms of re-experiencing and hyperarousal. Thus, our studies aim to bridge the     translational gap between theoretical and neurobiological models of PTSD to implementation of     clinical practice. The Target Engagement and Dosing Phase of this project, which is a pilot     study, will demonstrate target engagement and its association with laboratory measures of     PTSD-relevant neural processes.   "
3270|NCT03243136|"     A pervasive and persistent finding is the health disadvantage experienced by those in food     insecure households. While clear associations have been identified between food insecurity     and diabetes risk factors, less is known about the relationship between food insecurity and     incident type 2 diabetes.      The objective of this study is to investigate the association between household food     insecurity and the future development of type 2 diabetes.      The investigators used data from Ontario adult respondents to the 2004 Canadian Community     Health Survey, linked to health administrative data (n = 4,739). Food insecurity was assessed     with the Household Food Security Survey Module and incident type 2 diabetes cases were     identified by the Ontario Diabetes Database. Multivariable adjusted Cox proportional hazards     models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for type     2 diabetes as a function of food insecurity.   "
3271|NCT03243123|"     This is a single arm study aimed at evaluating the acute effects induced by a single session     of robot-assisted passive hand mobilization on local perfusion and upper limb function in     post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke     received 20 min passive mobilization of the paretic hand with robotic assistance. After the     intervention, significant improvements were found in forearm perfusion, muscle tone     significantly decreased and subjects reported decreased upper limb heaviness, stiffness and     pain. This study supports novel evidence that hand robotic assistance promotes local forearm     circulation, may help in the management of spasticity and acutely alleviates reported     symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.   "
3272|NCT03243110|"     The study will consist of three phases: Phase A: General population survey for estimation of     the prevalence of asthma, and prospective collection of resource utilization and     quality-of-life data for 12 months, Phase B: comparison of healthcare resource usage     collected prospectively to the data collected using administrative data in the population     recruited in Phase A, and Phase C: Economic modeling of asthma to extrapolate the findings     across Canada and into the future years.   "
3274|NCT03243084|"     Chronic pain is a severe disabling problem within society, affecting 25-30% of the United     States population.. Transcranial alternating current stimulation (tACS) has the potential to     provide a treatment option that is safe, scientifically-supported, low-cost, and     easy-to-administer method to effectively reduce symptoms in patients suffering from chronic     pain. The purpose of this study is to test the feasibility of using tACS to treat patients     with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for     optimizing the design of subsequent large-scale studies. The treatment rationale is to     renormalize the presumed pathological structure of alpha oscillations in the prefrontal     cortex (PFC) of patients with chronic pain.   "
3275|NCT03243071|"     The purpose pf this study is to evaluate the comparative effectiveness of a culturally and     linguistically tailored clinical trial literacy website in increasing likelihood of     participating in clinical trials. To achieve this objective,a randomized group design will     address the following patient-centered outcomes: willingness to enroll in clinical trials and     behavioral intent as well as likelihood of referring others to enroll in such trials) before     and after exposure to a culturally-tailored clinical trial literacy website. Health literacy     will be measured both before and post exposure to tailored messages. Participants will be     randomized into two groups. The intervention group (n=50) will have access to culturally     tailored website. Participants in the control group (n=50) will have access to NYU 's     standard trial participation website.   "
3276|NCT03243058|"     Randomized, controlled, double blinded, multicenter, phase I/II clinical trial to evaluate     the safety of low-dose IL-2 and to test whether low-dose IL-2 can prevent further loss of     beta-cell function in patients with established T1D, or even potentially improve ß-cell     function in such individuals, when IL-2 is given for one year (primary outcome). Equally     important, the study will carefully examine various effects of low-dose IL-2 on the immune     system in patients with T1D, including effects on Treg and other cell subsets, and     disease-specific autoimmune responses.   "
3796|NCT03236207|"     Infants/children with cow's milk allergy will take part in 2 double-blinded     placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random     order. If both food challenges are passed, subjects will be asked to consume the Test formula     in an at-home open challenge for 7 days.   "
3281|NCT03242993|"     This is a clinical trial category C as this is a first in man trial with an unapproved     investigational product. Nevertheless the risk is considered low due to the low dose ≤ 10μg.     No toxicity effects were observed preclinically at a dose >1000 -fold the intended dose.     Open-labeled, non-blinded, non-placebo controlled, multicenter study.      Primary objective:      Assessment of biodistribution and FR-specific tumor detection of [18F]- AzaFol as a PET     imaging agent in patients with FR-positive and FR-negative metastatic cancer of the ovaries     or lungs.      Secondary objective:      Calculation of the effective dose to the patient according to the tissue distribution data of     [18F]-AzaFol (Dosimetry)   "
3349|NCT03242083|"     Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because     of progressive deterioration of the macula, patients with AMD complain about progressive     visual problems that can impair their quality of life in the physical, mental and social     domains. The principal objective principal of this study is to describe the evolution of     quality of life between the diagnosis of secondary atrophic AMD and at 18 months after     confirmation of diagnosis.   "
3282|NCT03242980|"     In the era of test-and-treat, with anticipated high numbers of patients who will have     unsuppressed viral load (VL) due to poor adherence, simple, short and standardized adherence     interventions with documented efficacy will be needed. Achieving re-suppression in patients     with unsuppressed VL is beneficial for the health of the individual, important to reduce the     risk of transmission and has a direct cost implication because patients with sustained     unsuppressed VL will ultimately be switched to more expensive 2nd-line regimens.      Information is still largely lacking on how to best address adherence problems among patients     with unsuppressed VL. VL monitoring is recognized as a useful tool to reinforce adherence in     patients with unsuppressed VL. The Lesotho Guidelines recommend redoing a VL 8-12 weeks after     the first enhanced adherence counselling. To date no study has been published clearly     demonstrating higher re-suppression rates after enhanced adherence counselling for patients     with unsuppressed VL.      This project aims to test an adherence intervention for HIV-positive individuals on     first-line ART who have an unsuppressed viral load. A step wedged study will be used to     compare the effectiveness of a short, standardized adherence counselling followed by an SMS     reminder to the standard of care (≥ 2 unstructured adherence counselling sessions) in terms     of viral re-suppression rates and switches to 2nd line ART.   "
3283|NCT03242967|"     This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for     Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)   "
3284|NCT03242954|"     The purpose of this study is to examine how the consent process affects the acceptability of     participation in biomedical HIV prevention trials, from the perspective of behaviorally     high-risk minors and the parents of minor adolescents.   "
3285|NCT03242941|"     The purpose of this non-randomized, non-controlled, acute, single-arm research study is to     evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on     the interatrial septum. The possibility to terminate atrial arrythmias will also be     evaluated.   "
3286|NCT03242928|"     This will assess whether AFQ056 can have a beneficial effect by reducing cocaine use in     Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.   "
3287|NCT03242915|"     Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of     carboplatin and pemetrexed in EGFR (epidermal growth factor receptor) mutation and ALK     (anaplastic lymphoma kinase) positive NSCLC patients who have disease progression following     prior TKIs (tyrosine kinase inhibitors).   "
3288|NCT03242902|"     Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term     complaints reported by (non-) Hodgkin survivors. The SPARKLE study will test the efficacy of     two intensities of light therapy on cancer related fatigue. Additionally, it explores     possible working mechanisms of light therapy on CRF including improvements in sleep quality,     psychosocial variables (depression, anxiety, cognitive complaints, and quality of life), and     changes in biological circadian rhythms.   "
3289|NCT03242889|"     The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC)     delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese     participants with relapsed or refractory multiple myeloma (MM).   "
3290|NCT03242876|"     Research has shown that diets that give rise to a high glucose response are associated with a     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly     comprises of insulin resistance and glucose intolerance which gives an increased risk of type     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)     rather than rapidly (high GI) have health benefits which include reducing the risk of     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can     lower the blood glucose levels.      Therefore a lower glycemic index diet may have benefits in terms of type two diabetes and     heart disease management, and as a method for weight loss. There has been some research into     the effects of pomegranate on lowering blood glucose responses both chronically and acutely.     Mechanistic evidence suggests that this effect could be down to the organic acids found     within pomegranate juice. 16 volunteers were fed 50 g available carbohydrate from white bread     (109 g), and either 200 ml water (control) or 200 ml solution (test) containing citric acid     (3.8 g) and malic acid (119 mg) the quantities that are found in 200 ml pomegranate juice     (Biona) as analysed. Blood glucose was measured at baseline, and at 30 - 60 minute increments     over three hours. Glucose curves were plotted, and the area under the curve was calculated     and compared between conditions for each participant.   "
3291|NCT03242863|"     In this study, the investigators will vary the proportions of high- and low-energy-dense     foods served to preschool children at all meals and snacks during three 5-day periods. In the     three experimental conditions, the same foods will be served; only the amounts and     proportions of foods will be varied. In the Baseline condition, typical proportions of     age-appropriate foods will be served. In the Addition condition, the portion sizes of     low-energy-dense foods will be increased, and in the Substitution condition, the portions of     low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in     energy density. The primary aim is to determine the effect on children's energy intake of     varying the proportion of low- and high-energy-dense foods served, either by addition or     substitution, over 5 days. It is hypothesized that children will consume less energy when     they are served meals in which low-energy-dense foods are substituted for foods higher in     energy density over 5 days and that children will consume more energy when served meals to     which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily     energy intake in the three conditions will begin to converge across the 5-day period.   "
3292|NCT03242850|"     This study tests whether an enhanced primary cared based literacy promotion intervention     consisting of a video and text message will increase shared reading occurrences between     parents and children compared to the standard version.   "
3295|NCT03242811|"     It is important that asylum seekers should have as accurate age assessment as possible and     that children's fundamental rights are met by choosing methods based on best available     knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for     methods of medical age assessment of whether a person is over or under 18 years of age.      The primary issue is to investigate whether five selected growth zones in knee joint, ankle     and wrist individually or in combination can better determine the 18-year limit compared with     previous research.   "
5004|NCT03220373|"     The aim of this project is to gain a more specific understanding of how different cognitive     profiles predict residential treatment drop-out, treatment retention and post-treatment     outcome in a population with Substance Use Disorder.   "
3296|NCT03242798|"     Cirrhosis is the twelfth leading cause of death worldwide. Malnutrition is prevalent among     cirrhotic patients and is an important prognostic factor. Nutritional assessment is therefore     crucial for identifying patients at risk or with already established malnutrition and refer     them for nutritional intervention and support. In the current literature, nutritional     assessment of cirrhotic patients is performed using several tools and methods. However their     accuracy is widely affected by the underline disease and its complications. In addition, for     the majority of the parameters under study, no gold standard tools and methods have been     established so far. Studies on nutritional assessment in cirrhosis usually focus on one or     few aspects of nutritional status and not on a full nutritional assessment combining     information from medical, biochemical, nutritional, and body composition variables. Hence,     the present study aims at a thorough assessment of the nutritional status of 170 cirrhotic     patients using multiple widely available tools and methods, in order to assess their accuracy     and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition,     sarcopenia, sarcopenic obesity and cachexia.   "
3297|NCT03242785|"     The ADAMPA study is a pragmatic randomized clinical trial which aims to evaluate the     effectiveness of an intervention based on self-monitoring and self-titration of medication in     poorly controlled hypertensive patients 40 years and older. The total duration of the study     is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary     endpoint (Difference in mean systolic blood pressure, in mmHg, between the intervention and     control groups).   "
3298|NCT03242772|"     Children with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity     disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD     alone. Effective early treatments that account for ADHD symptoms have not been developed for     young children with ASD. The overarching goals of this study are to (1) evaluate a novel     early intervention that pharmacologically addresses ADHD symptoms prior to initiating early     behavioral intervention, and (2) identify changes in behavioral and neurophysiological     activity that may underlie improved outcomes in children with comorbid ASD and ADHD. The     primary aim of this study is to evaluate whether a stimulant treatment augments efficacy of a     novel, parent-delivered, behavioral intervention based on the Early Start Denver model     (P-ESDM) through a 30 week, double-blind, placebo-controlled Phase II clinical trial.     Secondary aims are to determine the efficacy of combined intervention in improving ADHD     symptoms and the efficacy, safety, and tolerability of Adzenys-XR-ODT in young children with     ASD+ADHD. The study will also examine correlations between behavioral changes and     state-of-the-art eye-gaze tracking (EGT) and electroencephalographic (EEG) biomarkers to     elucidate key ways in which ADHD impacts attentional and neural functioning in ASD+ADHD, and     to potentially identify new targets for intervention in children with ASD+ADHD.   "
3299|NCT03242759|"     This is a non-interventional, multi-center study to collect data from patients with     idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried     out at 10 medical centers, the expert centers where IPF patients are mainly managed in     Taiwan.   "
3300|NCT03242746|"     This study aims to assess how the proportion of the cervical volume/length removed during     treatment for cervical intraepithelial neoplasia (CIN) varies and whether this correlates to     the pregnancy duration at delivery   "
3301|NCT03242733|"     Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric     contents will be examined by using ultrasonography in fasted elderly patients scheduled for     hip fracture surgery. The primary outcome is the number of patients with stomach contents,     and the secondary outcome is the component of residual gastric contents.   "
3302|NCT03242720|"     With this pilot study, we are hoping to test the feasibility of a larger study in the future     and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial     fibrillation after successful catheter ablation procedure among patients with atrial     fibrillation and obstructive sleep apnea. The results from this study will help us refine the     design for a future larger study, and will ultimately improve care of patients with     obstructive sleep apnea and atrial fibrillation.   "
3303|NCT03242707|"     A new generation of minimally manipulated regenerative treatments are being offered at     clinics across the country, but there is no strong efficacy data to support their use. This     study will evaluate the efficacy of intra-articular autologous adipose tissue for patients     with mild-to-moderate knee OA, and determine how these treatments effect the biochemical     environment of the knee by comparing pre-injection and post-injection synovial fluid     biomarker profiles.   "
3304|NCT03242694|"     This prospective observational study is designed to describe the factors determining the     success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation     (AF). These factors - described as left atrial (LA) function - are simultaneously studied by     multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous     measurements are conducted before the PVI in AF and after the sinus rhythm converted due to     PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA     strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining     biomarkers from blood samples. During the one year follow-up period rhythm monitoring is     conducted by regular Holter-monitoring. Our aim is to define the predictive values of the     above mentioned factors and to create a new score system for predicting PVI success in     persistent AF population.   "
3317|NCT03242512|"     This is a single-center, open-label, dose-escalating study to evaluate the safety,     pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous     injection of a fully human monoclonal antibody of receptor activator for nuclear factor-κ B     ligand (RNAKL) (code name: TK006) in postmenopausal women.   "
3318|NCT03242499|"     Background: Recent evidence has shown that statins, especially lipophilic statins, may have a     neuroprotective benefit in Parkinson's disease (PD). Our group has previously screened a     library of 640 FDA-approved drugs in LRRK2-G2019S fly and mouse model of PD. We have     identified lovastatin exhibiting the most beneficial effect on rescuing dopaminergic neuronal     loss in both in vitro and in vivo. We aim to perform a randomized placebo-controlled trial     evaluating the disease-modifying efficacy of lovastatin in patients with early stage PD.      Methods and Study Design: This study will be a phase II, single-center, double-blind,     randomized, placebo-controlled parallel-group study. In this trial, we are going to examine     the possibility that lovastatin, a highly potent lipophilic statin, has disease-modifying     effects in PD. We are going to enroll 80 patients with early stage (defined as Hoehn-and-Yahr     stage 1) drug naïve PD patients or who have stopped medications for more than 1 month. There     will be three phases in the study. An initial 12-week screening phase was performed to     determine eligibility. Subjects will then be randomized to a 48-week double-blind treatment     period of lovastatin 80mg/day or placebo. Primary endpoints are changes in motor severity     based on Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor sub-score     (MDS-UPDRS part III, with higher numbers indicating more severe disease). At the start of the     study, participants will receive a baseline blood test for liver/renal function and serum CK     level, 18F-DOPA PET imaging, global cognitive test (Mini-Mental State Examination, MMSE), and     then will be randomized to either lovastatin or placebo group. Participants in both groups     will then attend further 5 clinic visits after 4, 12, 24, 36, and 48 weeks, where they are     asked about their health, any anti-parkinsonism medications that are added and received     MDS-UPDRS evaluation. During the follow-up period, the dose of anti-parkinsonism could be     added if both the patients and doctors thought the clinical condition deteriorated. Changes     in PD medication as measured by levodopa-equivalent dose (LED) will be recorded at each     visit. The secondary endpoints measured include MDS-UPDRS total scores, Part I and Part II     sub-scores, the timing and dose of added anti-parkinsonism medication during the treatment     period, the changes of 18F-DOPA PET uptake and MMSE scores, and global impression scale (GCI)     of patients and investigators at the end of the study. Serum lipid profiles (including total     cholesterol, triglyceride, LDL, and HDL), liver function and CK levels will also be checked     at the end of study. The follow-up phase at four week after treatment will evaluate any     changes of MDS-UPDRS and medication changes during this period.      Expected results: We hypothesize that lovastatin would slow down both motor and cognitive     symptoms deterioration and dopaminergic neuronal degeneration in patients with early stage     PD.      Importance of the study: Our study will provide Class II evidence that intensive lipid     lowering with lovastatin 80 mg/day decrease the disease progression in patients with early     stage PD.   "
3319|NCT03242486|"     Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal     astigmatism after cataract surgery.   "
3416|NCT03241212|"     This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What     I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a     validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3     months and 6 months. The intervention group will receive a minimum of 78 text messages     related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited     to respond to some text messages which will be in the form of a multiple-choice question and     if they do, they will receive an additional text message in response to their answer.   "
3305|NCT03242681|"     The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with     the standard simple probing in cases with congenital nasolacrimal duct obstruction .     Furthermore, we will identify associated anatomical anomalies. We believe results of this     study can be valuable in better understanding of this disease and provide a high evidence     level necessary to propose a classification and management algorithm.      Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction,     no past surgical management, with one or more of the below criteria will be included:        1. Non-resolving symptoms of epiphora and/or discharge.        2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical          antibiotics.        3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and          patients will undergo lacrimal tests before and after operation in one week, one month          and 3months based on a special record form. Patients will be randomly assigned to          simple probing group or endoscopy assisted probing group.      All operations will be performed in operative theater and under general anesthesia. Pre- and     post-operative examinations will be performed in plastic clinic in Farabi hospital.   "
3306|NCT03242668|"     To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.   "
3307|NCT03242655|"     People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV     infected people in the United States. Though new, direct-acting HCV medications are highly     efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate     treatment. We seek to improve HCV treatment uptake and cure among HCV and HIV/HCV+ PWIDs by     testing a primary care based HCV Group Evaluation and Treatment UPtake (HCV GET-UP)     intervention. If efficacious, this innovative care intervention could provide a means to     reduce the growing mortality from HCV, as well as decrease the current reservoir for HCV     transmission.   "
3308|NCT03242629|"     To compare the clinical sedative effect and safety using 10% chloral hydrate during     ophthalmic examinations for oral vs enema group.The patients were randomly divided into two     groups (oral group and enema group) using a computer random number generator with a 1:1     allocation (simple randomization, odd number for oral group and even number for enema group).   "
3309|NCT03242616|"     Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and     mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these     are largely done before the wide use of premedication (steroid and vitamin B12) for     pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a     commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.      This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in     patients with recurrent or metastatic breast cancer previously treated with or resistant to     an anthracycline and taxane.   "
3310|NCT03242603|"     Neuroblastoma is a neoplasm of the sympathetic nervous system which affects mostly children     younger than 5 years of age. It is a heterogeneous disease, with nearly 50% of patients     presenting with a high-risk phenotype. After standard treatment, the 2-year event-free     survival (EFS) for high risk neuroblastoma (EFS) is only about 50%. Immunotherapy with     anti-GD2 antibodies has been shown to improve EFS in Children's Oncology Group and SIOPEN     trials.      The anti-GD2 antibody mediates neuroblastoma cell killing primarily through     antibody-dependent cell-mediated cytotoxicity (ADCC). Natural killer (NK) cells are the main     effectors of ADCC. We postulate that infusion of expanded activated NK cells from healthy     haploidentical donors along with anti-GD2 antibody will enhance neuroblastoma killing.   "
3311|NCT03242590|"     Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult     hypogonadal male subjects.   "
3312|NCT03242577|"     This is a single-center, exploratory comparative pilot study to identify the most appropriate     method for microbial consortia sampling from the skin.      Ten subjects are expected to complete the study at one investigative site in the United     States.      The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1,     subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be     combined into one visit. Visit 1 will involve the informed consent process, screening, and     enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3)     different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape     stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a     laboratory for analysis.   "
3313|NCT03242564|"     The purpose of this study is to determine whether red light therapy using LED 650nm red light     for body contouring of the waist, hips and thighs is as effective as red light therapy using     Laser 635nm red light.   "
3314|NCT03242551|"     The BINC-B trial is a diagnostic and interventional study in which various function imaging     methods as Magnetic Resonance Imaging (PWI, DWI and DCE-MRI) and will be compared with common     imaging methods (mammography and/or ultrasound) to investigate if an early response to a     combined neoadjuvant chemotherapy in operable or potentially operable breast cancer. For     breast cancer patients with positive HER-2, additional Herceptin could improve the response     further. In this study the efficacy of combined neoadjuvant therapy with or without Herceptin     should be evaluated and the role in predicting the tumor response with different imaging     should be estimated.   "
3315|NCT03242538|"     The investigators hypothesize that two pelvic relaxation exercises will be feasible and safe     to perform by subjects daily before radiation during the participant's treatment and will     decrease variability of sacral slope measurements on daily port films. The investigators will     observe trends in the daily variability and change in the sacral slope in each participant to     determine if this could decrease variability. The investigators will compare these     measurements to a retrospective cohort that did not have the exercises, but did demonstrate     variability. Reducing set-up variability (which inadvertently occurs during radiation) is     important to improve radiation targets and diminish potential adverse effects. The     investigators will query participants for objective and subjective feedback on the exercises     and record frequency and duration of the two exercises.   "
3316|NCT03242525|"     The aim of the present study is to quantify the time advantage achieved by the use of POCT     compared to conventional coagulation diagnostics. A further objective of this study is an     analysis of the result quality of POCT for the TPZ / INR.   "
15566|NCT03081728|"     to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug     followed by 24 hours continous infusion of drug   "
3320|NCT03242473|"     Acute pancreatitis is increasingly common diagnosis in children. Most of the guidelines     related to the details of management of acute pancreatitis are extrapolated from the adult     literature. There is only limited data regarding management of acute pancreatitis in     children. The mainstay of management is bowel and pancreatic rest with significant fluid     support to minimize the effect of the cytokines on the pancreas and other organs. The     standard fluid choices are Lactated Ringer's solution (LR) and normal saline (NS). Currently,     both LR and NS are used at the discretion of the treating physician as the standard of care     for acute pancreatitis. The investigators hope to examine the question of ideal fluid choice     for fluid resuscitation in children with acute pancreatitis by assessing recovery time in the     context of measured inflammatory markers and SIRS status at 24 and 48 hours after admission.     The ideal fluid choice in the initial resuscitation of acute pancreatitis has not been     effectively evaluated before in the pediatric population. Even if there is no statistically     significant difference between the two fluid options, this trial will still provide     clinically significant information.   "
3321|NCT03242460|"     In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed     MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse     the second-line LD when the bortezomib-containing treatment failed to salvage the patients.     Patients who have relapsed MM after exposure to the above agents and have progressive disease     have a short life expectancy. Third-line therapy is needed for retrieving the patients     hereafter. And substantial proportion of patients will attain an advanced age. To examine if     time to disease progression is maintained and tolerability is improved with lower     dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is     achieved after 3 months of treatment with the initial dose. Three months later (6 months     after the initial treatment), the response remains in stable disease, 2nd dose reduction     (dexamethasone 10mg or prednisone 50mg) will be carried out.   "
3322|NCT03242447|"     The purpose of the study is to determine the impact of the offer to participate in the     e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on     increasing knowledge of sexual health and the impact of trauma on sexual decision-making and     preventing teen pregnancy and high-risk behaviors 12 months after enrollment.   "
3323|NCT03242434|"     This longitudinal, prospective study aims to establish the magnitude and time course of     changes in intestinal permeability; establish the optimal method for assessment of intestinal     permeability in thermally injured participants: describe the participant population most     likely to benefit from a new medicinal product which could prevent changes in intestinal     permeability; and improve our understanding of the links between intestinal damage, changes     in the gut microbiome and microbial translocation to the systemic circulation following     thermal injury. The key factors of interest in this study are to understand the impact of     thermal injury on intestinal permeability in thermally injured participants compared to     healthy participants; and to understand the changes in intestinal permeability over time.     Approximately 15 eligible healthy participants and 25 thermally injury participants will be     included. The sugar test material (STM) comprises of Lactulose, Mannitol and Sucralose and     will be intermittently administered enterally to all the participants. The full duration of     the study for healthy participants will be approximately two weeks and 6 months for thermally     injured participants. In order to enter this study thermally injured participants will be     required to co-enroll in this study and an allied study entitled: A Multi-center, Prospective     Study to Examine the Relationship between Neutrophil Function and Sepsis in Adults and     Children with Severe Thermal Injury (SIFTI-2). (reference number IRAS ID: 200366).   "
3324|NCT03242421|"     Binocular vision tests are guided by the principle that uniform motion and focus of the eyes     may be trained, but exercising the simultaneous movement of the pupils is necessary and     important in achieving optimal and lasting results (Horwood & Toor, 2014). These tests have     been in use for over 70 years and represent the foundation of therapy for visual deficiencies     such as the inability of the eyes to move together. Despite their frequent use, no one has     ever formally evaluated how good these tests are.      One such evaluation method is reliability. A reliable test is one that will give the same     result when repeated on multiple occasions (i.e. test-retest reliability) or by different     people (inter-rater reliability). An unreliable test gives widely varying results when     repeated, which would make changes in a patient's test results difficult to interpret.     Therefore, this study aims to determine the test-retest reliability of seven binocular vision     tests across two independent measurements. The investigators will measure 20 healthy people     ages 18 to 35 years for each of these tests on two separate occasions, one week apart. Since     these tests have been in use for many years, we are expecting the two measurements to be     within acceptable range of each other.      The tests being investigated measure: 3D vision (i.e. gross stereoscopic acuity), uniform     movement of the eyes (i.e. motor punctum proximum), ability of the eyes to adapt to a     target moving towards and/or away from the eyes (i.e. binocular fusion with convergence and     divergence), quick movements of the eyes (i.e. saccadic movements), natural alignment of the     eyes (i.e. anatomic oculomotor deviation), and double vision as a target is moved towards the     eyes (i.e. convergence fusional proximum).      The results of each test will be analyzed individually. If the tests are perfectly reliable,     we would expect the results of the first test to equal the results of the second test for     each participant. To examine the test-retest reliability the difference between the first and     second test for each individual and across all individuals' scores summed together will be     assessed.   "
3325|NCT03242408|"     This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021     in adult hypogonadal male subjects.   "
3326|NCT03242395|"     PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a     degree of neurocognitive dysfunction following a major burn, that this neurocognitive     dysfunction is due to an underlying neuroinflammatory process by fMRI neuroimaging     techniques, and that the neurocognitive deficit is associated with a reduced quality of life.   "
3327|NCT03242382|"     Non-randomized, open, single cohort, phase II, multicenter national clinical trial. 19 sites     in Spain.      Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive     days followed by 7 rest days to comprise a complete cycle of 28 days.      Treatment will continue until disease progression, development of unacceptable toxicity,     non-compliance, withdrawal of consent by the patient or investigator decision      The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1     at 6 months   "
3328|NCT03242369|"     Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most     important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low     volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could     be suitable substitution of polyethylene glycol.   "
3396|NCT03241472|"     Infertility is defined as a couple's inability to become pregnant after one year of     unprotected intercourse in women 35 years old and younger, and for six months in women over     age 35 years. In any given year, about 15 percent of couples in North America and Europe who     are trying to conceive are infertile   "
3333|NCT03242304|"     Acute ischemic stroke (AIS) represents an economical challenge for health systems all over     the globe. Despite increasing knowledge of the pathophysiology of AIS, there is no     satisfactory treatment to revert the resulting brain damage. Changes of neuroactive steroids     have been found in different neurological diseases. In this regard, the investigators have     previously demonstrated that old patients with AIS show changes of plasma cortisol and     estradiol concentrations, in that increased steroid levels are associated with a     deterioration of neurological status and a worse cognitive decline. The present study     assessed in patients with AIS if changes of behavior, brain-derived neurotrophic factor     (BDNF) and nitrites (NO-2) (nitric oxide soluble metabolite) bear a relationship with the     degree of hypercortisolism. To this purpose, the investigators recruited patients     hospitalized at the Central Military Hospital emergency room within the first 24 hours of     AIS. Subjects were divided into two groups, each one composed of 40 control subjects and 40     AIS patients, including men and women. The neurological condition was assessed using the     NIHSS and the cognitive status with the Montreal Cognitive Assessment (MoCA test). The     emotional status was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS),     whereas the Modified Rankin Scale (MRS) was used to determine the functional condition. BDNF     and NO-2 plasma levels were measured by ELISA and the Griess reaction method, respectively.   "
3334|NCT03242291|"     This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber     reinforced flowable composite compared to a conventional resin-based flowable composite     during management of initial carious lesion in adult population over a one year period.   "
3335|NCT03242278|"     The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF)     patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of     rivaroxaban.      The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced     by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal     function).   "
3336|NCT03242265|"     This study will look at measuring the activity of natural killer (NK) cells using the in     vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate     biopsy.   "
3337|NCT03242252|"     Primary Objective:      To demonstrate the superiority of sotagliflozin dose 1 and 2 versus placebo on HbA1c     reduction in patients with Type 2 diabetes who have inadequate glycemic control and moderate     renal impairment      Secondary Objectives:        -  To assess the effects of sotagliflozin dose 1 and 2 versus placebo with respect to          additional measures of glycemic control, blood pressure, and body weight        -  To evaluate the safety of sotagliflozin dose 1 and dose 2 versus placebo   "
3338|NCT03242239|"     The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin®     (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the     pharmacokinetics, safety, tolerability and immunogenicity.   "
3339|NCT03242226|"     The purpose of this study is to evaluate the effect of +3.00ADD vs single vision spectacle on     the progression of myopia in children. Many studies applying bifocals or multifocal     spectacles to intervene the progression have been carried out based on the idea that myopia     was caused by excessive accommodation, however, the effect was limited. The possible reason     is that bifocal or multifocal spectacles still not fully adjust the accommodative error in     myopia children.   "
3340|NCT03242213|"     The current randomized controlled trial is a pilot study that will assess the effectiveness     and feasibility of a mobile phone application intervention. The objective is to determine     whether the use of a mobile health application for patient self-management of depression     improves patient-provider engagement for patients diagnosed with major depressive disorder.   "
3341|NCT03242200|"     The purpose of this research study is to understand if a mobile app is useful to assist young     adult female survivors of childhood cancer in the self-management of survivorship-related     needs.   "
3342|NCT03242187|"     This study is designed to assess the surgical, oncological and functional outcome of either     the laparoscopic or trans-anal TME in management of mid and low rectal cancer.   "
3343|NCT03242174|"     To assess health and lifestyle behavior of pregnant women in Baton Rouge including women     receiving traditional obstetrical prenatal care and delivering in a hospital and those     receiving prenatal care from a midwife and delivering at the birth center.   "
3344|NCT03242161|"     This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid     like patch that is designed to detect real-time changes in interstitial alcohol     concentrations in human subjects. The changes in interstitial alcohol concentrations will be     compared to blood alcohol concentrations to determine the patch's validity against the gold     standard.   "
3345|NCT03242135|"     role of RDW as anon invasive method for predicting liver cell failure & portal hypertension     in cirrhotic patient   "
3347|NCT03242109|"     Cardiovascular disease and malignancies account for more than 70% of all causes of mortality     and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle,     that often defines the line between health and sickness. So far studies aiming at identifying     risk factors have mainly come from Northern Europe and the USA. It was to understand this     balance between genetics and environmental determinants better, and to tailor appropriate     preventive strategies for Italian and other Southern European populations, that the Moli-sani     study was launched, transforming a small Italian region into a large scientific laboratory:     the Molise lab.      Each participant received a thorough medical check-up at no cost to either him/her or the     national health service, resulting in thousands of hours of free public health care. With a     completely computerized system, Moli-sani is a paperless study, in which researchers and     participants communicate using recently developed technologies such as mobile phone text     messages (SMS). The biological data bank (the MoliBank) is one of the largest in Europe.     Paying particular attention towards innovation and new technologies, the Moli-sani study has     placed itself at the cutting edge of a new paradigm crossing research and prevention   "
3348|NCT03242096|"     Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID     EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter   "
5005|NCT03220360|"     To compare the efficacies of MTA, calcium hydroxide preparation, Biodentine and TheraCal LC     that are commonly used in pediatric dentistry in the preservation of vital pulp in carious     deciduous teeth.   "
3350|NCT03242070|"     The high prevalence of chronic illnesses is a serious public health problem in the U.S., and     more than 70 million adults age ≥50 have at least one chronic illness. Management of chronic     conditions requires long-term use of complex treatment plans and can cause unintended     consequences, such as increased risk of medication errors. Patient portals (PPs), a federally     supported health information technology (IT), can be especially helpful for patients with     chronic illnesses. Patients can now access their own health records and directly communicate     with care providers through PPs. Prior findings suggest a great potential for using PPs to     improve care quality, and the federal government funds healthcare organizations to implement     this tool nationwide. Despite the potential benefits, the overall PP adoption rate in the     U.S. is low. A lack of PP use among older adults has been addressed as a particular concern.     When only older adults who use the Internet are considered, however, their proportion of PP     use is similar to other age groups. A few studies also reported that older adults are     receptive to PPs. In general, older adults need additional support for learning to use PPs,     as they tend to be less familiar with technology. Currently, most older adults receive little     or no PP support from their providers. This is an important gap in the nation's health IT     initiative because without appropriate support, older adults will not be able to use this     robust health tool, missing an important opportunity to improve their health outcomes. In an     effort to fill this gap, the investigators developed and tested an older adult friendly     Theory-based Patient portal eLearning Program (T-PeP) to support older adults in using PPs     for their care. In the proposed feasibility study, the investigators plan to (Aim 1) optimize     and implement a vendor-agnostic T-PeP and conduct formative and process evaluations; and (Aim     2) assess the preliminary impact of T-PeP on PP use and selected outcomes (PP knowledge,     self-efficacy for PP use and health decision making, health communication, and medication     reconciliation). If successful, this study could directly affect quality of care provided to     older adults and the success of the national health IT initiative. Findings from this study     will also provide hospitals, vendors, and policymakers with in-depth information on older     adults' current PP usage patterns and other challenges in using various types of PPs at the     national level.   "
3351|NCT03242057|"     Extubation failure is a significant problem in preterm neonates and prolonged intubation is a     well-documented risk factor for development of chronic lung disease. Out of the respiratory     modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous     positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are     the most commonly used.      A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared     to nCPAP (30% vs. 40%)      NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation     in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment     of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported     to improve patient - ventilator synchrony and minimize mean airway pressure and ability to     wean an infant from a ventilator. However till date there has been no head to head comparison     of extubation failure in infants managed on NAVA with conventional ventilator strategies.      In this study the investigators aim to compare primary extubation failure rates in     infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible     infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA     ventilator settings and will be assessed for primary extubation failure (defined as     reintubation within 5 days after an elective extubation).   "
3352|NCT03242044|"     Congenital diaphragmatic hernia is a severe birth defect, with a prevalence of 1:2000 to     1:3000 live births where a defect in the diaphragm results in, herniation of the abdominal     contents into the chest with subsequent compression of the intrathoracic structures and     respiratory insufficiency after birth. Respiratory insufficiency is managed with intubation     and mechanical ventilation. In addition to managing respiratory insufficiency, intubation     prevents entrainment of air into the intestines and further compression of the lungs and     heart. Resuscitation of infants with CDH also involves placement of a nasogastric tube (NG)     into the stomach for removal of entrained air and secretions. As part of routine     resuscitation in infants with CDH intubation and NG tube placement are performed after the     delivery personnel separates the baby from the placenta by cutting the umbilical cord. This     study will assess the feasibility, maternal and fetal tolerance and the optimal approach to     performing these initial steps of resuscitation with an intact umbilical cord. The     investigators have randomly chosen 10 maternal and infant with congenital diaphragmatic     hernia dyads to demonstrate feasibility as well as determine pitfalls and difficulties and     the optimal approach to a complex resuscitation with an intact umbilical cord.   "
3353|NCT03242031|"     Despite the fact that the efficacy of a single session of multispot laser has been     demonstrated in the treatment of patients with diabetic retinopathy as compared with four     sessions of single-spot laser, the management of panretinal photocoagulation in the different     healthcare establishments in France has remained unchanged notably because there is no     specific reimbursement for this new treatment protocol.      Although the benefits of reducing the number of sessions and thus the costs associated with     the treatment for the patient and the payer seem to be obvious, the medico-economic impact of     modifying the treatment strategy thanks to the technological changes must be evaluated to     provide deciders with additional information.   "
3354|NCT03242018|"     Primary Objective:      To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to     hemoglobin A1c (HbA1c) reduction in patients with Type 2 diabetes who have inadequate     glycemic control and severe renal impairment      Secondary Objectives:        -  To assess the effects of sotagliflozin dose 2 versus placebo based on change from          baseline in HbA1c        -  To assess the effects of sotagloflozin doses 1 and 2 versus placebo        -  To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo   "
3355|NCT03242005|"     Open label, randomized 2-period cross-over study comparing two continuous subcutaneous     insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed®     Quick-set®   "
3356|NCT03241992|"     This study will be the first to assess the use of an electronic health records patient portal     for patients with Inflammatory Bowel Disease. We know that patients with Inflammatory Bowel     Disease (IBD), have reduced quality of life, high rates of depression and anxiety, do not     receive routine preventative health maintenance (such as vaccines) at the same rate as the     general public, and have low adherence to medications. We are seeking to understand whether     an electronic health record patient portal (EPIC's MyChart), can be utilized to improve     quality of life in this patient population.   "
3357|NCT03241979|"     Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to     benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios,     however its use in spontaneously breathing pediatric patients undergoing tubeless airway     surgery has not been described. This is a physiologic study that evaluates the feasibility of     THRIVE during pediatric airway surgery under self-respiration.   "
5128|NCT03218735|"     The purpose of this study is to compare the incidence of composite neonatal morbidity and     birthweight >4500 grams among uncomplicated large for gestational age (LGA) fetal growth at     delivered 37 weeks versus expectant management.   "
3358|NCT03241966|"     The investigators are examining how aspects of daily function are perceived in persons with     PD and in those who interact with them on a regular basis. If eligible, participants will     receive a set of online questionnaires by email. The questionnaires will take about 1 hour to     complete, and can be done at the participant's convenience. The investigators are looking for     volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and     proficient English speakers). If a spouse, family member, significant other or other close     associate is available (age 18 or older, proficient English speakers), the investigators will     send them questionnaires as well. There is no monetary or other compensation for this study.     For more information, please contact the Vision and Cognition Laboratory at     vcognition@gmail.com or 617-358-1377.   "
3359|NCT03241953|"     In this randomized, controlled study, 18 patients with peri-implantitis were included. A     total of forty dental implants were debrided with either ultrasonic instruments (test, n=20)     or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width     (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months.     CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical     periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the     surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces     was removed by ultrasonic scaler and air polishing using abrasive powders or conventional     plastic scaler with klorhegsidin combination.   "
3360|NCT03241940|"     This phase I trial studies the best dose and side effects of CD19/CD22 chimeric antigen     receptor (CAR) T cells when given together with chemotherapy, and to see how well they work     in treating children or young adults with CD19 positive B acute lymphoblastic leukemia that     has come back or does not respond to treatment. A CAR is a genetically-engineered receptor     made so that immune cells (T cells) can attack cancer cells by recognizing and responding to     the CD19/CD22 proteins. These proteins are commonly found on B acute lymphoblastic leukemia.     Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving CD19/CD22-CAR T cells and     chemotherapy may work better in treating children or young adults with B acute lymphoblastic     leukemia.   "
3361|NCT03241927|"     Melanoma is an immune-modulated malignancy and immune checkpoint modulators which inhibit     PD-1 function (pembrolizumab, nivolumab) have demonstrated clinical efficacy as treatment for     patients with stage IV melanoma. Pembrolizumab across a range of doses in phase I     investigation has demonstrated clinical efficacy with RR approximately 27%. By better     understanding how NK cell function and exhaustion interplays with PD1 function and activity,     potentially more efficacious combination therapies can be developed. The pharmacodynamic     studies to be performed as part of this trial will provide such information.   "
3362|NCT03241914|"     To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will     not be inferior to returning the endometrial tissue to a normal state than megestrol acetate     alone in patients with early endometrial cancer.   "
3363|NCT03241901|"     This clinical trial evaluates the advantage of prolonging the therapeutic life span of     Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine     0.25mg/kg. The study will have two arms, one that will receive standard treatment of     uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the     prolonged dose of 6 days together with single low dose primaquine. This approach is expected     to provide strategies for malaria control in an era of imminent Plasmodium falciparum     resistance.   "
3364|NCT03241888|"     To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will     not be inferior to returning the endometrial tissue to a normal state than megestrol acetate     or LNG-IUS alone in patients with endometrial atypical hyperplasia.   "
3365|NCT03241875|"     The aim of this study is to evaluate the effect of premedication with pregabalin or     gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.   "
3397|NCT03241459|"     To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment     of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral     and/or popliteal arteries.   "
3398|NCT03241446|"     A prospective, open-label, single center, study to evaluate pharmacokinetics and dosimetry of     intravenously injected Tc 99m tilmanocept at three mass doses (50 µg, 200 µg, and 400 µg)     radiolabeled with 10 millicuries (mCi) Tc 99m.   "
3797|NCT03236194|"     The investigators will be studying the development of the microbiome over the first year     after birth in light of various environmental influences - e.g. mode of delivery, diet (and     diet changes), antibiotic exposure, GERD medication exposure.   "
3366|NCT03241862|"     20 subjects with mild to severe oral commissures or none to severe perioral lines will be     enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days     after Optimal Cosmetic Results has been achieved, as judged by the investigator.      Changes in the projected first impression will be assessed by a total of 200 blinded     evaluators rating the photographs of subjects from the baseline and from 14 days post     achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed     through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic     alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale,     Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the     self-assessment of subjects using the Global Aesthetic Improvement Scale.   "
3399|NCT03241433|"     This study is a single-center RCT. Potential subjects with symptomatic non-permanent AF will     be enrolled to determine the effect of sprint interval training (SIT) in comparison to     moderate-intensity continuous training (MICT) and non-exercise control in reducing AF burden.     The Investigators will enroll 60 patients during the first 12 months of the study. Baseline     data collection will be conducted during the first month after enrollment. After baseline     data collection, subjects will be randomized (1:1:1) to SIT vs. MICT vs. non-exercise     controls. The exercise training will last for 3 months followed by final data collection     which will be completed in 1 month.   "
3400|NCT03241420|"     To determine the utility and sensitivity of the lung clearance index (LCI) technique as a     marker of small airways disease in adults with chronic lung conditions compared to healthy     adults, adjusting for age, sex and smoking status.   "
3367|NCT03241849|"     Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to     the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality     due to hemorrhage, infection, or other surgical complications such as those resulting from     hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is     increasing due to the rise in the rate of deliveries by Cesarean section.      Placenta accreta is a potentially life-threatening obstetric condition that requires a     multidisciplinary approach to management. The incidence of placenta accreta has increased and     seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta     accreta are those who have myometrial damage caused by a previous cesarean delivery with     either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of     placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize     potential maternal or neonatal morbidity and mortality.   "
3368|NCT03241836|"     Mullerian duct anomalies (M.D.A) consist of a set of structural malformations resulting from     abnormal development of the paramesonephric or Müllerian ducts.      The prevalence of M.D.A ranges from 0.001 to 10% in the general population and from 8-10% in     women with an adverse reproductive history.      The most widely accepted classification system of different Mullerian anomalies was     established by the American Fertility Society (A.F.S) in 1988 (7). This classification chart     divides anomalies into the following seven classes: (I) hypoplasia/agenesis, (II) unicornuate     uterus, (III) uterine didelphys, (IV) bicornuate uterus, (V) septate uterus, (VI) arcuate     uterus, and (VII) diethylstilbestrol-related.      Over the years, multiple imaging modalities have been used to diagnose M.D.A.     Hysterosalpingography (H.S.G) allows for assessment of the uterine cavity and tubal patency     but limited in visualizing the external contour of the uterus.      Two dimensional tans vaginal ultrasound (2 D TV US) is quick, readily available, economical     and lacks radiation. However, image degradation can occur with large patients, overlaying     bowel gas, and the external contour may be difficult to visualize.      Three-dimensional (3 D) ultrasound is a new technique that has shown, in experienced hands,     to be more accurate than two dimensional ultrasound and equal or better than MRI at assessing     M.D.A because it is easy, less expensive, less time consuming, lack radiation and provide     good anatomical details for internal and external contour.      However, MRI is currently considered the best imaging modality for M.D.A. It has excellent     soft-tissue resolution and multi-planar imaging capabilities, lacks radiation , provides     clear delineation of both the internal and the external uterine anatomy.and provide accurate     evaluation of associated renal anomalies, zonal uterine differentiation and the presence or     absence of functioning endometrium. Imaoka et al., Pellerito et al. and Reinhold et al.     stated that it is important in patients with hypo-plastic and unicornuate uterus to evaluate     the function of uterine corpus and cervix to predict the future fertility and incidence of     endometriosis. MRI has been shown to have excellent agreement with the clinical diagnosis of     the sub types of M.D.A.   "
3369|NCT03241823|"     Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that     more than 80 million people are chronically infected worldwide, with 3-4 million new     infections and 350,000 deaths occurring each year because of HCV-related complications .   "
3370|NCT03241810|"     This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in     postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative     metastatic, unresectable breast cancer.   "
3371|NCT03241797|"     The aim is to evaluate EUS-FNA efficacy for AIP diagnosis using a 22-gauge (G) needle.   "
3372|NCT03241784|"     This is an open-label pilot study to determine the safety and tolerability of infusions of     autologous CD4+ CD25+ regulatory T cells with concomitant subcutaneous IL-2 injections in 4     subjects with ALS.   "
3373|NCT03241771|"     In the setting of naloxone standing orders, this study will assess if direct outreach with a     web-based Naloxone Navigator 1.0 to patients prescribed chronic opioid therapy (COT)     changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about     overdose and naloxone   "
3374|NCT03241758|"     A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using     Doppler ultrasound and the impact of such changes on erectile function and quality of life of     patients. The baseline study will be compared with the study one year after surgery.   "
3375|NCT03241745|"     The purpose of this study is to test the safety of nivolumab and find out what affects, if     any, nivolumab has on people and their risk of uterine cancer. The investigators also want to     find out what effects, good or bad, nivolumab has on the patient and their cancer.   "
3376|NCT03241732|"     Chronic Traumatic Brain Injury (cTBI) symptoms exist in individuals who experienced previous     traumatic brain injuries. There are 80-90 thousand individuals who are clinically diagnosed     with cTBI, with estimated costs at greater than 60 billion dollars. However, there is a lack     of studies using comprehensive diagnostic imaging tools to better understand physiological     ramifications of the injury that may help guide therapy.   "
3377|NCT03241719|"     The objective of this study is to develop a feasible and safe regimen for minimization of     immune suppression in recipients of vascularized composite allotransplants (VCA) using a     daily dose of recombinant IL-2. In order to achieve this aim, this trial will:        1. Perform VCA in 5 eligible subjects;        2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of          regulatory T cells in subjects who received VCA; and        3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA          and recombinant IL-2.      This trial will also investigate if it is possible to predict immune rejection in VCA using     blood and tissue samples from recipients of VCA.      Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These     technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR     imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.   "
3410|NCT03241290|"     THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and     its ability to be used during surgery.   "
3411|NCT03241277|"     Objective: To investigate the impact of nonsurgical periodontal treatment in patients with     social anxiety disorder (SAD) and controls without phobia.   "
3401|NCT03241407|"     The purpose of this trial was to determine the effect of a triclosan-containing toothpaste in     the clinical parameters and in the profile of osteo-immunoinflammatory mediators in the     peri-implant crevicular fluid (PICF) as a preventive therapy of peri-implant experimental     mucositis in cigarette smokers   "
3402|NCT03241394|"     Obesity is associated with a chronic low-grade inflammation characterized by macrophage     infiltration in adipose tissue that induces insulin resistance and the appearance of     metabolic syndrome (MS). The aim of the study was the investigation of whether circulating     monocyte subsets are differentially regulated in MS.   "
5982|NCT03207594|"     The purpose of this study is to improve cancer care and the delivery of cancer care.     Researchers are interested in studying patient reported information and examining how     different factors may impact cancer care.   "
3378|NCT03241706|"     The purpose of this research study is to learn more about how sugar levels in the liver     affect the ability of people both with and without type 1 diabetes. People with type 1     diabetes do not make their own insulin, and are therefore required to give themselves     injections of insulin in order to keep their blood sugar under control. However, very often     people with type 1 diabetes give themselves too much insulin and this causes their blood     sugar to become very low, which can have a negative impact on their health. When the blood     sugar becomes low, healthy people secrete hormones such as glucagon and epinephrine (i.e.,     adrenaline), which restore the blood sugar levels to normal by increasing liver glucose     production into the blood. However, in people with type 1 diabetes, the ability to release     glucagon and epinephrine is impaired and this reduces the amount of sugar the liver is able     to release.      People with type 1 diabetes also have unusually low stores of sugar in their livers. It has     been shown in animal studies that when the amount of sugar stored in the liver is increased,     it increases the release of glucagon and epinephrine during insulin-induced hypoglycemia. In     turn, this increase in hormone release boosts liver sugar production. However, it is not     known if increased liver sugar content can influence these responses in people with and     without type 1 diabetes. In addition, when people with type 1 diabetes do experience an     episode of low blood sugar, it impairs their responses to low blood sugar the next day. It is     also unknown whether this reduction in low blood sugar responses is caused by low liver sugar     levels.      The investigators want to learn more about how liver sugar levels affect the ability of T1D     and CON to respond to low blood sugar.   "
3379|NCT03241693|"     The aim of this study was to assess the effect of a blended-learning model on physiotherapy     students´ attitude, knowledge and opinions towards learning professional ethics.      A simple-blind clinical trial was performed. An eight-month blended learning program to teach     professional ethics in clinical practices was worked out. An online syllabus and online     activities were elaborated, whilst face to face active participation techniques were     performed to discuss ethical issues detected among practices. Students´ attitudes, knowledge     and opinions towards learning professional ethics were assessed. Non-parametric tests were     carried out. All the participants were informed about the study and procedures, and provided     written informed consent.   "
3380|NCT03241680|"     Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of     15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer.      This high incidence is explained by the pre-neoplastic lesions of the cervix being probably     related to the practice of unsafe sex and to a poor local immune response against HPV.      Human papillomavirus (HPV) infection affects people of any age, although it is more common in     young people, probably due to increased sexual activity in that period.      The association between high-risk HPV and anus neoplasm in men and women with     immunodeficiency or immunosuppression has been confirmed and measures related to surveillance     are standardized.      In patients without immunodeficiencies, this association is still unclear, which may     contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus.      The frequency of the cancer of anus previously considered low, is currently in considerable     elevation, mainly squamous cell carcinoma (SCC).      The causal relationship between this virus and cancer of the cervix and the anus is     established. These facts have motivated the inclusion of this disease as STD, which justifies     the necessity of adopting surveillance measures in the clinics of sexual, gynecological and     urological diseases.      Cancer of the anus, when diagnosed in the early stage, makes healing possible with less     aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary.      Concerned about possible anal cancer, some gynecologists have referred patients with genital     HPV to search for anal infection.   "
3381|NCT03241667|"     This is a non-randomized, open label, uncontrolled first in human safety study, testing the     the material used in the artificial kidney device in subjects already on hemodialysis.      Six subjects already on hemodialysis, who meet the study inclusion and exclusion criteria,     and who dialyze at one of the UCSF associated hemodialysis units will be recruited. Each     subject will be tested during one non hemodialysis day, at the UCSF Moffitt-Long Hospital     Acute Hemodialysis Unit (AHU).      The artificial kidney engineers have created a blood flow system that can be substituted for     the dialysis filter in a standard hemodialysis machine. This is NOT a dialysis filter. It     allows the subjects blood to come in contact with the material while the blood is being     circulated as is regularly done during a hemodialysis session.   "
3382|NCT03241654|"     In mechanically ventilated patients during supine position, alveolar collapse usually     distributes in dependent lung region.Decrease of flow trigger sensitivity might improve     homogeneous of tidal volume distribution.   "
3383|NCT03241641|"     Treatment of CHB patients with genotypic resistance to NUCs has been problematic due to the     lack of data from randomized trials. Recently, two randomized trials comparing the efficacy     of TDF monotherapy versus TDF and ETV combination therapy in CHB patients with documented     genotypic resistance to adefovir (ADV) or ETV demonstrated TDF monotherapy was not     statistically different in viral suppression at week 48 of treatment.1,2 The extension study     based on the above two trials merged study subjects from these trials with changing from TDF     and ETV combination group to TDF monotherapy to evaluate long-term efficacy and safety of TDF     monotherapy for multidrug-resistant patients. At the time of merging of 192 subjects, by     intention-to-treat analysis, 66.3% of TDF group and 68.0% of TDF-ETV group had virological     response as determined by serum HBV DNA <15 IU/mL. (in press) Three year long-term follow up     study showed that the proportion of virologic suppression increased to 76.8% and 72.2% in     TDF-TDF and TDF/TDF-ETV groups, respectively( P=0.46). (in press)      TAF, a novel prodrug of tenofovir was developed to have greater stability in plasma than TDF,     thereby enabling more efficient delivery of the active metabolite to target cells at a     substantially lower dose. The reduced systemic exposure of tenofovir offers the potential for     an improved safety profile compared to TDF a benefit that demonstrated in a recent clinical     trial in patients with HIV infection. In a recent double-blind randomized phase 3     noninferiority trial with 873 treatment naive patients who were positive for HBeAg, the     proportion of patients receiving TAF who had HBV DNA <29 IU/mL at week 48 was 64%, which was     non-inferior to the rate of 67% in patients receiving TDF (P=0.25).3 In the safety profile,     TAF group had significantly smaller decrease in BMD than TDF group in the hip and spine, as     well as significantly smaller increases in serum creatinine at week 48.3 For treatment naive     HBeAg negative patients, a recent study with 425 subjects applied the same methodology and     showed noninferiority in efficacy of TAF compared to TDF at week 48.4 Considering     noninferiority in efficacy and superior bone and renal safety from TAF, TAF might be     considered preferred choice of NUC instead of TDF. However, it is still unknown whether TAF     would show similar efficacy and safety profile in patients with multidrug-resistant CHB.   "
3412|NCT03241264|"     The purpose of this study is to evaluate the safety, tolerability, and the effects two     ND-L02-s0201 have on the body   "
3413|NCT03241251|"     The Psychosocial Assessment Tool (PAT) is an international used instrument for the screening     for psychosocial risk factors in families of a child with cancer. This study want to     investigate the validation and evaluation of the clinical value of the Flemish translation of     the psychosocial assessment tool   "
3384|NCT03241628|"     Epidermolysis Bullosa (EB) is a group of genetic conditions causing extensive, painful skin     blisters and wounds. Four main types of EB are recognised, which all affect the hands but     those patients usually requiring hand therapy interventions have Recessive Dystrophic EB     (RDEB).      The proof of concept study is part of the GLOVE (Generation and evaLuation Of hand therapy     deVices for Epidermolysis bullosa) project. The project aims (i) to develop two hand therapy     devices; a disposable dressing glove and splint glove to manage blisters, wounds and     contractures that occur on the hands of people with RDEB (ii) to design and implement the     Hand Therapy Online (HTO) electronic patient record system and (iii) to determine the cost     effectiveness of the devices and the HTO system.      The proof of concept study focuses on testing the clinical performance and cost effectiveness     of the dressing glove when compared with conventional dressings.      Recruited GLOVE participants will be invited to participate in the 14 week study, conducted     using a quasi-experimental, n-of-1 research design. Patients who have not participated in     GLOVE will also be invited to join. Participants will be asked to follow their usual dressing     regime for six weeks. At week 7, they will be given several pairs of dressing gloves to     replace their usual dressings, or starting to wear the glove if they avoid dressings normally     and familiarise themselves. If participants usually wear their gloves to maintain their web     spaces, they will wear these on top of the dressing glove to help assess compatibility.      Participants will provide feedback twice a week from week 7 on the dressing glove by     answering 12 questions (TELER indicators) validated in the Pilot study (REC no: 16/LO/1046)     using the HTO system. Data from the HTO system will be used by the Health Economist to     determine the dressing glove and HTO's cost effectiveness.   "
3385|NCT03241615|"     The aim of the study is to investigate the relationship between dysphagia symptom severity     and quality of life of the patients with neurogenic dysphagia.   "
3386|NCT03241602|"     The advancement of laparoscopy and minimal access surgery has greatly influenced the     evolution of anaesthetic techniques. However, postoperative pain intensity may be     significant, with up to 40% of patients unsatisfied by routine analgesia and up to 80%may     require rescue opioids during their hospital stay. Diagnostic gynaecological laparoscopy has     no origin of pain other than the abdominal gas insufflations itself only. Pain relief after     diagnostic laparoscopy, being a day case, is an issue of great practical importance.The aim     of this study is to compare the efficacy of combining both pulmonary recruitment and     intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy     shoulder pain regarding severity and frequency      Study Design :      Interventional Prospective Randomized Double-blind Controlled Trial      Methodology This study is a randomized double blinded control trial. It will be conducted at     Kasr-al ainy hospital, faculty of medicine, Cairo university. Approval of ethical committee     and written informed consent will be obtained. 88 female patients, aged 18-45 years , ASA 1     or 2 , scheduled for diagnostic gynaecologic laparoscopy will be included. Females who are     (ASA) ≥ 3, alcoholic, drug abusers, allergic to amide LAs, with pre-existing chronic pain     disorders, or receiving opioids or tranquilizers for > 1 week preoperatively are excluded.     Also if the operation included any interventional procedure or was converted to an open     procedure, or had postoperative complications that could increase postoperative pain, it will     be excluded. Consenting patients will be randomly allocated to either of three study groups :     GPL : Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine.     GPS: Patients will receive pulmonary recruitment maneuver and intraperitoneal saline. GC :     Patients will receive passive exsufflation through the port site. The patient will attend at     the pre anaesthetic room 1 hour before the procedure. A 20 Gauge cannula will be inserted     peripherally and the patient will be premedicated with intravenous Midazolam 0.02 mg kg-1,     Ranitidine 50 mg, 10 mg Metoclopramide.      In the operative room, standard monitoring will be applied to the patient. Anaesthesia will     be induced with propofol 2 mg kg-1, Fentanyl 1 mcg kg-1 , Atracurium 0.5 mg kg-1 and the     trachea will be intubated after mask ventilation for 3 minutes. Anaesthesia will be     maintained with IPPV , isoflurane in 100% oxygen and muscular relaxation with atracurium     0.1mg kg-1every 15 minutes. Depth of anaesthesia was adjusted according to clinical signs.     Laparoscopy is done using CO2 as distension medium. The patient will be placed in a     Trendelenburg position in order to provide optimum conditions for laparoscopic view. In     groups GPL and GPS , the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5     mg/kg) or the same volume of normal saline, for intraperitoneal administration. This ensures     the surgeon and the anaesthesiologist are blind to the patient's group. The solution to be     instilled will be splashed under the right diaphragmatic area by the surgeon and complete the     procedure. At the end of the procedure, the patient will be placed back from trendelenburg     position. In groups GPL and GPS , a pulmonary recruitment maneuver will be done and consist     of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The     anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds. In     group GC CO2 will be removed by passive exsufflation through the port site and gentle     abdominal pressure will be applied to evacuate the residual gas. Residual neuromuscular block     is antagonized with atropine 1.2 mg and neostigmine 2.5 mg and extubation will be done     according to extubation criteria. In the recovery room, patient will be asked about     post-operative pain and it'll be controlled using Meperidine 1 mg kg-1 and given by a nurse     who is unaware of the nature of the intraoperative analgesia. Then, the patient is discharged     to the ward according to the standard criteria. In the ward, patient will be asked to fulfill     a questionnaire at 6, 8 and 10 hours postoperative using the visual analogue score (VAS) of     pain severity. Patients were questioned as to presence of Side effects (nausea, vomiting).      Possible Risk : Pneumothorax , Local anaesthetic toxicity : CNS depression (lightheadedness     and dizziness, difficulty focusing, tinnitus, confusion, and circumoral numbness) ,     excitation ( tremors tonic-clonic convulsions) , respiratory depression and cardiac     dysrhythmias .   "
3387|NCT03241589|"     This study will measure the impact of two teledermatology apps, VA Telederm and MY Telederm,     WITH TWO SEPARATE TRIALS on access to dermatology care. The overall hypothesis is that sites     implementing Department of Veterans Affairs' (VA) teledermatology mobile apps will     significantly augment the use of teledermatology and improve Veterans' access to skin care     relative to control sites. Specifically, the investigators hypothesize that VA Telederm will     facilitate the implementation and adoption of teledermatology among primary care clinic     staff, increasing use by existing programs and potentially expanding teledermatology to new     sites while reducing patient travel to dermatology clinics. Additionally the investigators     hypothesize that My Telederm will improve established patients' ability to follow-up with     dermatology care remotely, while opening up dermatology clinic space for other patients.   "
3388|NCT03241576|"     In 3 laboratory experiments the effect that receiving a small vs. large portion size of food     has on later intake of that food was examined   "
3389|NCT03241563|"     The subjects and evaluating investigator will be blinded to the treatment, thus maintaining     double-blind status. By nature of the varying volumes of injection, the treating investigator     will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced     4 weeks apart.      Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow     up visits will be performed 3 and 5 days after each injection session to assess for side     effect and tolerability profile. After the final injection session, additional follow up     visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be     recorded at baseline and at end of study.   "
3390|NCT03241550|"     The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of     multiple doses of intravenous (IV) isavuconazonium sulfate administered daily in pediatric     patients. The PK data will be utilized to establish a pediatric population PK model of     isavuconazole, the active moiety of isavuconazonium sulfate.   "
3391|NCT03241537|"     In local advanced prostate cancer patients with clinically positive metastatic regional lymph     node, the optimal treatment is still unanswered. For these patients, radiotherapy combined     with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from     NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better     survivals than hormonal therapy alone.      This randomized phase III trial compare hormonal therapy alone with combined hormone with     radiotherapy in clinically pelvic lymph node metastatic prostate cancer.   "
3392|NCT03241524|"     The sample comprised 31 female undergraduate students attending a private University in João     Pessoa, northeastern Brazil. The inclusion criteria were: age between 19 and 35 years,     heterosexual, active sex life, living in a stable relationship for at least 6 months no     pregnancy or parturition in the last 6 months, clinically healthy and agreeing with the terms     for participating in the study. All participants gave their informed consent to take part in     the study.   "
3393|NCT03241511|"     The goal of this project is to assess repeated and ongoing oral care and the way it may     affect inflammation and quality of life in hemodialysis patients. Two treatment groups will     be compared:        -  1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by          multiple appointments of maintenance        -  2) single session of gum disease therapy with only one session of deep tooth cleaning          Samples of blood will be obtained for study to examine the changes of inflammatory          substances in the blood as a result of the two different gum disease treatments. Also, a          14-question survey will be discussed with you to assess oral health related quality of          life (OHIP-14) and the way it is affected by oral care.      For this project, four dialysis centers will be randomly assigned to either of the treatment     groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent     forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a     result, all participants in the same dialysis center will belong to the same treatment group     (either #1 or #2) and presented with the corresponding consent form.      This dialysis center has been randomized to treatment group # 1; therefore you will receive     ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple     appointments of maintenance.   "
3394|NCT03241498|"     The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of     a medication optimisation intervention (delivered in GP practices by pharmacists to patients     at risk of medication related problems), on healthcare resource utilisation and patient     outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will     engage with patients, thought to be at a higher risk of medication related problems, within     their GP practice in order to help identify areas for improvement   "
3395|NCT03241485|"     This is a randomized clinical trial in patients undergoing robotic myocardial     revascularization with intraoperative extubation. Patients will be randomized into placebo or     intrathecal morphine groups to assess postoperative pain scores and patient satisfaction.     Patients will also be assessed for side effects from the intervention.   "
3414|NCT03241238|"     This study will investigate the effects of different fermenting fibers on liking of foods.   "
3403|NCT03241381|"     Melasma is a commonly acquired, pigmentary disorder characterized by symmetric melanosis of     the face. The relation between vitamin D deficiency and periodontitis have been evaluated and     reported to occur in conjunction with anaemia. Vitamin D deficiency is related to sun     exposure factors and melasma is one of the result of actinic associated facial     pigmentation.To correlate melasma with clinical evidence of periodontitis and serum vitamin D     levels and its co-occurrence with anaemia. Patients with facial melasma within the age group     of 30-70yrs in both the genders were included in Group A (50). Clinical examination was     performed for evidence of anaemia and periodontitis. Furthermore, estimation of serum-vitamin     D levels and haemoglobin percentage was also done. The same method was matched with similar     controls Group B (50) patients without having melasma on face.      The study revealed significant correlation between melasma and periodontitis with vitamin D     abnormalities (p value<.05), where as insignificant correlation between melasma and Hb%. The     association of melasma with serum vitamin D abnormalities and periodontitis may preclude for     early detection and subsequent treatment of all of them. The presence of melasma with in     patients having periodontitis and vitamin D abnormalities may be a syndromic triad.   "
3404|NCT03241368|"     This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC)     plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with     known CD and mucosal disease.      The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for     detecting active CD, by visualizing the small bowel and colon in subjects with known CD and     mucosal disease.      There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow     ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month     follow ups along with a Quality of Life questionnaire at 12 month follow up. Concomitant     medication and adverse events information will be collected baseline and 3-, 6-, 9- and 12     month follow ups.   "
3405|NCT03241355|"     The study aims to explore whether prophylactic dietary supplementation with prebiotic     inulin-type fructans is able to influence the intestinal microbiota and the frequency of     infectious disease episodes in kindergarten children during a winter period.   "
3406|NCT03241342|"     GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen     receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is     currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in     postmenopausal women. Urinary incontinence and pelvic floor disorders are major health     problems for women, especially as they age. Pelvic floor muscle relaxation has been found to     correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and     lower urinary tract are crucial for supporting the pelvic organs and micturition; however,     damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic     organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass     and strength, lack of oral bioavailability and known potential risks have limited their use.     Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved     muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with     fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical     data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower     urinary tract disorders, as both testosterone and its more potent metabolite,     dihydrotestosterone, have anabolic effects on muscle.   "
3407|NCT03241329|"     The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and     oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the     follicular fluid. This evaluation will be completed by a trancriptomic analysis from the     cumulus cells of the oocyte.      The normal and pathological oocyte cohort after controlled ovarian stimulation will be also     characterized by identifying the oocyte leading to live birth.   "
3408|NCT03241316|"     The investigators will conduct two rural surveys in Thailand and Lao PDR to improve the     understanding of antibiotic-related health behaviour among the general population. One survey     will capture a cross-section of health behaviours that is representative for the rural     population in Chiang Rai (Thailand) and Salavan (Lao PDR), the other survey will create a two     round village-level panel data set to study the evolution of health behaviours in the context     of public engagement activities. The investigators will also collect complementary data about     village-level infrastructure through observational check-lists, and collect secondary data on     patient load from primary care units catering to their survey villages. As part of the     questionnaire testing process, the investigators will conduct (and collect as primary data)     cognitive interviews to improve the survey tool, to interpret their data, and to justify     their methodological choices.   "
3409|NCT03241303|"     Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate     content in the distal small intestines induced by alpha-glucosidase inhibition during meal     ingestion in patients with type 2 diabetes   "
3415|NCT03241225|"     The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly     mistreatment) victims, to work in synergy with EM mistreatment resolution services that     provide safety planning, support services, and links to legal services. PROTECT is built on a     model which postulates that chronic stress promotes dysfunction of the cognitive control     (CCN) and reward networks, impairing the victims' ability to flexibly respond to the     environment and limits their reward activities. PROTECT therapists work with victims to     develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has     been designed in an iterative process with community EM providers of the New York City (NYC)     Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and     referral for service. In the current study, the investigators will compare the effectiveness     of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental     health services (EM/MH). The investigators intend to enroll 80 subjects that will participate     in the study for approximately 12 weeks.   "
3417|NCT03241199|"     The purpose of this pilot study is to investigate whether some patients who were started on a     2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI,     while maintaining or even deepening the molecular response as a cost-effective treatment.     Eligible patients will be switched to imatinib 400mg daily, with regular molecular     monitoring.   "
6572|NCT03199859|"     1. Observe the characteristics of delirium patients, searching for early diagnostic methods          or finding risk factors        2. Design a guideline for delirium, diagnosis or treatment   "
3423|NCT03241121|"     SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of     time restricted feeding in metabolic syndrome      The purpose of this study is to assess eating patterns among teenagers and adults with a new     method, going beyond the pen-and-paper food diaries, and to investigate whether time     restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in     individuals with metabolic syndrome   "
3424|NCT03241108|"     This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international     multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid     Arthritis   "
3425|NCT03241095|"     The purpose of the study is to investigate if osteopathic manipulative treatment (OTM)     improves the golf swing of the participants. Study participants will be randomized into three     groups, we will stratify by age and gender to make them as uniform as possible. One group     will receive no intervention other than a 10-minute break between the pre and post     measurements. A second group will receive a sham intervention where the doctor will pretend     to give the participant OTM. The third group will receive real OTM.      Participants will perform a sample of 10 golf swings pre and post intervention which will be     measured by a golf simulator. They will also complete a brief health history and pre/post     self-evaluation of their swing.   "
3426|NCT03241082|"     The overall objective of the proposal is to evaluate the ability of ultrasound to predict and     routinely (weekly) monitor changes in the body composition of healthy preterm infants in the     neonatal intensive care unit (NICU) in response to nutritional intake. The investigators     hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight     gain and assess the adequacy of nutritional provision for premature infants in the neonatal     intensive care unit.      The investigators will address the hypothesis in the following Specific Aims:      Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat free     mass in healthy, premature infants. Body composition will be assessed using ultrasound     measurements and the validated method of air displacement plethysmography (ADP). Stable     isotope dilution techniques will be used in a subset of our population as a secondary source     of validation.      Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant     (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to     obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen,     quadriceps) until discharge in healthy, premature infants.   "
3427|NCT03241069|"     Dynamic variations of bio-impedance measured cardiac output using pharmacologic (inhaled     nitrate) and non pharmacologic intervention (sitting position, passive leg rising and     valsalva maneuver) could be used to detect acute heart failure in patients admitted to the ED     for dyspnea.   "
3442|NCT03240874|"     Diabetes during pregnancy is a challenging clinical situation requiring substantial patient     engagement. The investigators have developed a novel early-phase tool, called SweetMama,     incorporates educational, motivational and supportive elements to positively impact maternal     health behaviors. This phase of work involves develop an optimized version of SweetMama via a     2-step sequential process of in-depth usability testing - focus groups and individual     usability testing followed by refinement of SweetMama based on participant input.   "
3428|NCT03241056|"     A small (N = 24) pilot study developed a new and brief cognitive-behavioural therapy (CBT)     module for checking symptoms (CBT-C) in obsessive-compulsive disorder (OCD). CBT-C targets     maladaptive beliefs about memory and results show that it is effective at significantly     decreasing checking symptoms as compared to a waitlist control. The objectives of the current     investigation are to further investigate CBT-C by (1) replicating the pilot results in a     larger sample; (2) using an active control condition (treatment as usual) as the comparison     condition (3) including a 6-month follow-up, and (4) determining whether the association     between maladaptive beliefs about memory at pre-treatment assessment are related to degree of     checking symptom reduction following CBT-C. The findings of the study will have theoretical     significance in adding to our understanding of the maladaptive belief domains relevant to the     development and maintenance of OCD and supporting the cognitive model of compulsive checking.     The relevant clinical significance is the further development of an intervention that could     improve outcomes in treatment of persons with OCD. The key practical outcome of the research     would be to add a stepped care offering to patients with OCD.   "
3429|NCT03241043|"     Single centre, open-label, randomized, controlled, cross over study to evaluate the     pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in de novo liver     transplant recipients   "
3430|NCT03241030|"     The purpose of this study is to see if sucralfate, a medication commonly used for patients     with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level     and improve their ability to drink.   "
3431|NCT03241017|"     The trial assess the progression-free survival (PFS) two years after autologous stem cell     transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with     durvalumab.   "
3432|NCT03241004|"     This study aims to determine if anesthetic depth can be deepened non-pharmacologically     through use of sleep masks. This study seeks to demonstrate a relationship between the depth     of anesthesia with application of sleep masks intraoperatively and in the critical care     setting.   "
3433|NCT03240991|"     This study aims to describe quality of life in hereditary or acquired non drug-related     bradykinin-mediated angioedema patients, using validated questionnaires   "
3434|NCT03240978|"     Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched     groups including high intensity exercise, moderate intensity exercise, and non-exercise     groups. The exercise program will consist of three sessions per week over the course of 12     weeks, under the supervision of our in-house exercise specialists and physiologists. The     effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be     evaluated.   "
3435|NCT03240965|"     This study evaluates changes in swallowing using endoscopic swallowing studies and measuring     of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older     (>60 years) volunteers will serve as control.   "
5228|NCT03217435|"     The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial     allograft from living-related donor is more effective than limbal conjunctival allograft from     living-related donor for ocular surface reconstruction in patients with limbal stem cell     deficiency (LSCD).   "
3436|NCT03240952|"     Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient     requirements concomitant with a reduction in energy requirements, decreases in appetite and     energy intake. Currently there is a gap in knowledge of the factors that are associated with     malnutrition in the elderly in Singapore. In addition, there is no reference database on     anthropometric measurements and biochemical indices for elderly with a range of nutrition     status in Singapore. Thus, the objectives of this cross-sectional study are to examine     factors influencing nutritional status and to determine the reference values for     anthropometric and biochemical measurements related to nutritional status for     community-dwelling elderly in Singapore.   "
3437|NCT03240939|"     A randomized, open label, single dose, two-way crossover clinical trial to investigate the     pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil     administered in healthy male volunteers   "
3438|NCT03240926|"     The main purpose of this study is to assess the accuracy of a non-invasive wearable     technology in the form of a wristband.   "
3439|NCT03240913|"     The primary objectives of this study are to: 1) develop an educational tool known as the     Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the     options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine     what to expect if they choose either option; 2) assess the extent that the PROM-DA improves     patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA     in multiple sites and more patients.   "
3440|NCT03240900|"     Described as the Angelina Jolie Effect, rates of prophylactic mastectomy with immediate     implant-based reconstruction are increasing dramatically as more women with genetic     predisposition towards breast cancer are seeking surgical prevention. Advances in surgical     techniques allow for the creation of an aesthetically pleasing postoperative breast mound;     however, a common complaint is the lack of sensation to the skin and nipple of the     reconstructed breast due to injury and stretch of the sensory nerves. Numbness of the breast,     nipple, and areola is an unnatural feeling for the patient, as well as a potential risk for     injury or burns as the woman is unable to feel pain.      Our laboratory has previously shown that electrical stimulation (ES) is an effective way of     improving nerve regeneration after injury to the nerves of the upper and lower extremities.     Proven to improve motor outcomes following carpal and cubital tunnel release and sensation     following injury to the digital nerves, this technique is a likely mechanism of restoring     sensation of the breast as well.      In this study, we will follow thirty women undergoing prophylactic skin-sparing mastectomy     with immediate implant-based reconstruction. At the time of surgery, patients will be     randomly assigned ES to either the right or left breast. That breast will be reconstructed     first and stimulated for one hour while the other breast is reconstructed. At the completion     of the case, all wires will be removed. We will test sensation (tactile, temperature, 2-point     discrimination, sharp/dull discrimination, and protective sensation) prior to surgery then     again at 6, 12, 18, and 24 months following surgery to evaluate the effects of ES on sensory     return. Patients will be provided with a survey to assess return of erogenous sensation.   "
3441|NCT03240887|"     A randomized control trial will be conducted in high schools in North Carolina and New York     City to determine the impact of a school-based, positive youth development program on both     sexual behaviors associated with teen pregnancy and education outcomes.   "
16219|NCT03073200|"     The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric     participants with moderate-to-severe plaque psoriasis.   "
3443|NCT03240861|"     This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1     TCR (T cell receptor)engineered peripheral blood mononuclear cells (PBMC) and peripheral     blood stem cells (PBSC) after a myeloablative conditioning regimen to treat patients with     cancer that has spread to other parts of the body. The conditioning chemotherapy makes room     in the patient?s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells)     to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is     intended to replace the immune system with new immune cells that have been redirected to     attack and kill the cancer cells and thereby improve immune system function against cancer.   "
3444|NCT03240848|"     In this study, the investigators provide participants who had congenital cataract the     artificial intelligent clinic or normal clinic in the purpose of seeking out a better way to     make a definite diagnosis with high efficiency and accuracy, and report a prospective,     randomized controlled study aiming at comparison of artificial intelligent clinic and normal     clinic for diagnosing congenital cataract.   "
3445|NCT03240835|"     The purpose of this study is to study the function of pre-albumin, retinol conjugated protein     and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for     local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.   "
3446|NCT03240822|"     This is a 4-year, non-randomized, single center, patient self-controlled, clinical trial     (though enrolled subjects will be followed for life as are all transplant patients) for     patients seeking allotransplantation of the male external genitalia (MEG), or penile tissue,     as a feasible reconstructive strategy for the treatment of devastating and irreversible     injuries to the genitalia. In addition to receiving penile allotransplantation and     post-operative monitoring and support, enrolled patients will receive an innovative and     clinically proven immunomodulatory protocol that combines lymphocyte depletion of the     recipient with donor bone marrow cell infusion. Patients will be treated with lymphocyte     depleting induction therapy, donor bone marrow cell infusion and tacrolimus. After the first     year, maintenance immunosuppression will be modified gradually and cautiously (tapered dose     reduction or spaced frequency dosing of tacrolimus) in selected patients based on a critical     evaluation of clinical and immunologic outcomes. Outcomes will include but not be limited to     functional metrics (sensation, erection, voiding), psychosocial (body integrity, adaptation     to transplant) and health related quality of life (HRQOL) measures.   "
3447|NCT03240809|"     An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of     Brodalumab in Pediatric Subjects   "
3448|NCT03240796|"     In this study, the investigators give participants who had a lens implantation before a     secondary intraocular lens implantation in the purpose of reduce complications of surgeries     for dense cataract , and report a prospective, non-randomized controlled study aiming at     comparison of minimal invasive lens surgery and traditional cataract surgery for treating     congenital cataracts   "
3449|NCT03240783|"     Aim: In subjects with acute sciatica (≤ 4 weeks duration), this is a pilot comparative     effectiveness study to evaluate feasibility and to determine final sample size for a future     adequately powered randomised controlled trial of (i) CT-guided transforaminal lumbosacral     epidural steroid injection, and (ii) oral dexamethasone, in a masked (blinded), randomised,     sham injection and oral placebo controlled trial.      Study Design: 60 patients with acute sciatica will randomised 1:1:1:1 to receive either (i)     epidural steroid injection & oral placebo, (ii) epidural normal saline injection & oral     placebo, (iii) oral dexamethasone & IM sham-injection, (iv) IM sham-injection & oral placebo.      Outcomes: The primary outcome is reduction of disability at 3 weeks using the Oswestry     Disability Index. Secondary outcomes include reduction of disability at 6 and 48 weeks.   "
3450|NCT03240770|"     The investigators hypothesize that brief, daily application of HFA will increase the     efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or     discomfort. The investigators will divide subjects into 5 groups changing clear aligners at     different time intervals with or without HFA application for 5 minutes/day to assess the     effect on: time intervals between aligners, cytokine activity, and pain perception.   "
3451|NCT03240757|"     In the present study the investigators compared the hormonal and metabolic effects of three     meal loads very popular among Italian eating habits, both in the resting- and exercising     state. Given the lack of time is considered a common barrier to exercise adherence, we wanted     to identify a low dose of exercise capable to produce health benefits in the post-absorptive     status elicited by three commonly consumed meal-models in Mediterranean countries. To this     end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and     three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low     intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia,     insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each     test-meal load.   "
3452|NCT03240744|"     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,     is a member of the Human Enterovirus species A, family Picornaviridae. Its infection     occasionally leads to severe diseases and death, with central nervous system (CNS) damage.      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated     in animals but no final results of clinical trials, such as attenuated vaccine, subunit     vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been     finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015.     Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine     is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from     July 2016. The purpose of phase IVc is to evaluated the immunogenicity of the inactive EV71     vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei     Province, China.   "
3453|NCT03240731|"     multicentric interventional biomedical research phase II, prospective, non-randomized     evaluating a haploidentical marrow transplants after reduced-intensity conditioning and     prevention of GvHD based on cyclophosphamide administration post transplantation in patients     with severe sickle cell disease.   "
3454|NCT03240718|"     This is a randomized, controlled, within-patient, single-blinded, pilot study that will     evaluate the impact of laser treatment on burn HSc relative to self-matched control scars.     The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain,     itch and patient satisfaction.   "
3455|NCT03240705|"     Clerkship causes significant stress to medical students. Some interventions to increase     well-being have been described but none have been studied prospectively in this context.      The primary objective of this study is to examine the effects of gratitude journaling on     medical clerks' perceived well-being.      Students will be randomised to one of two groups: gratitude journaling or no intervention.     The participants of the experimental group will be asked to complete an online gratitude     journal 3 times per week and will be compared to the participants in the control group.      The students in both groups will answer a standardised questionnaire evaluating well-being     before and after their surgical rotation.      Those randomised to the intervention group will perform gratitude journaling three times a     week during their surgical rotation. This activity consists of writing something that made     them feel happy during their day.      Those randomised in the control group (no intervention) will proceed with their normal     rotation, without additional gratitude journaling.      The main outcome will be evaluated by comparing the well-being at the end of the surgical     rotation as evaluated by a composite well-being assessment scale between both groups.   "
3456|NCT03240692|"     This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial     magnetic stimulation device for treatment-resistant depression. In this open label study, all     participants will receive accelerated theta-burst stimulation.   "
3457|NCT03240679|"     This study is being done to assess the use of scaffold products in promoting constructive     healing as determined by the ability of the resection site to lift during follow-up.   "
3458|NCT03240666|"     The buccal cavity is colonized by numerous microorganisms whose the number and composition     could be modified with medical background (diseases and drugs) and the level of oral hygiene     of the patients. Among all microorganisms identified in the periodontium, few of them are     implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria     are identified for their ability to degrade periodontal tissues.      Although the periodontitis is established to be the consequence of bacterial virulence and     immune dysfunction, these factors fail to explain the refractory periodontitis of some     patients to etiologic treatment .      Others microorganisms such as protozoans could have an impact on this disease.   "
3459|NCT03240653|"     The purpose of this research is to review data already collected and to collect new data from     adults and children in England with Gaucher Disease to determine clinical factors which     predict severity and response to therapy of Gaucher disease especially in the areas of bone,     cancer and brain conditions.   "
3485|NCT03240315|"     This is a 3 year longitudinal study to establish a personalized prediction and prevention     system for acute exacerbation of chronic obstructive pulmonary disease（AECOPD). Data will be     collected which contained with clinical, pathophysiology, etiology and immunology information     of chronic obstructive pulmonary disease(COPD) patients and analyzed by data mining combined     with Internet technology.   "
3460|NCT03240640|"     Shortness of breath (dyspnea) is an important symptom during physical exertion in patients     with chronic obstructive pulmonary disease (COPD) and is related to respiratory muscle     weakness. Dyspnea is a multidimensional sensation. The sensory perceptual domain (perceived     dyspnea intensity) has been study extensively. The perception of respiratory distress     (unpleasantness of dyspnea) has not received as much attention. Inspiratory muscle training     (IMT) has been shown to improve inspiratory muscle function and reduce dyspnea intensity.     Balance impairments increasing the risk of falling is another recognized problem in patients     with COPD. Postural balance has been shown to be especially impaired in patients with COPD     who have pronounced respiratory muscle weakness. Improvements in respiratory muscle function     might improve balance control in patients. Respiratory Muscle Metaboreflex is known as     respiratory muscle work during exercise reflexively induces sympathetically mediated     vasoconstrictor activity, there by compromising blood flow and oxygen delivery to active limb     and respiratory muscles.      Eight weeks of controlled IMT is hypothesized to reduce both intensity as well as     unpleasntness domain of dyspnea perception, improve postural control and improves blood flow     and oxygen delivery to limb muscles in patients with COPD who have pronounced respiratory     muscle weakness.   "
3461|NCT03240627|"     Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8     cutaneous solution versus placebo in children and adolescents with moderate to severe scalp     alopecia areata.      Phase 2/3 study performed in Germany, Bulgaria and Romania in 100 patients.   "
3462|NCT03240614|"     Hypoxemia is a life threatening complication during emergency airway management. Despite     advances in technology and training, hypoxemia still occurs in up to a quarter of all     intubations placing patients at high risk for damage to vital organs and death. A key method     in the prevention of hypoxemia is known as preoxygenation which has been shown to decrease     the incidence of hypoxemia. Currently there are two conventional methods for preoxygenation     in the literature, however recently a new method has been described as a possible alternative     method. What is unclear in the literature is if one modality is superior than the other for     preoxygenation. The goal of this interventional study is to determine if one method of     preoxygenation is superior to the other. This is a 3 arm interventional cross over designed     study comparing three interventional methods for preoxygenation. Non-rebreather mask,     bag-valve mask and high flow nasal cannulae.   "
3463|NCT03240601|"     Involuntary muscle activity, often called spasticity, is a common problem following spinal     cord injury (SCI) that can make it hard to move. Many things can cause spasticity including:     muscle stretch, movement, or it can happen for no reason, and it is often described as an     uncontrolled muscle spasm or feeling of stiffness. Drugs are typically used to treat     spasticity, but they often have side effects, like muscle weakness, which can add to movement     problems. Rehabilitation therapies offer alternatives to drugs for treating involuntary     muscle activity, and rehabilitation can also improve daily function and quality of life.     These benefits may be greater when several rehabilitation therapies are used together.      Walking ability can be improved with a type of therapy called locomotor training. This type     of therapy may also have the benefit of decreasing spasticity. When locomotor training is     combined with electrical stimulation, the benefits of training may be increased. In this     study, investigators will use a kind of stimulation called transcutaneous spinal cord     stimulation (tcSCS) to stimulate participants' spinal cord nerves during locomotor     training.   "
3464|NCT03240588|"     The objective of the study is to characterize the relationship between select objective     metrics and clinical outcomes in chronic pain patients treated with Boston Scientific     commercially approved neurostimulation systems.   "
3810|NCT03236025|"     This study aims to use a three arms randomized clinical trial study to evaluate the     effectiveness of a video-led intervention in helping male smokers planning to have a baby in     Mainland China to quit or reduce the cigarette smoking.   "
3467|NCT03240549|"     Previous studies have shown that the addition of bevacizumab to the standard first-line     platinum-based combination therapy can improve the objective response rate of patients with     advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data     from these published literatures suggest that the improvement in objective response rates is     due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of     patients achieved objective remission after continuing treatment with the regimen after     receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles     of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the     objective response rate of such patients 20%, and may improve survival. For the above     reasons, design this study to validate our hypothesis.   "
3468|NCT03240536|"     This is a randomized study intended to produce a reduction in ordering of inappropriate tests     by general practitioners as determined by recommendations from the CRA's Choosing Wisely     guidelines. This reduction of inappropriate testing is expected in referrals to the     rheumatologists randomized to the intervention group. This study will further explore which     recommendations from the Canadian Rheumatology Association (CRA)/Canada Choosing Wisely     campaign have the most impact on regional referring physicians to the Rheumatology clinic at     St. Joseph's Hospital, London.   "
3470|NCT03240510|"     The goal of this study is to evaluate the Salah Azaïz Cancer Institute male breast cancer     patients population over a period of 14 years.      Goal of the retrospective part: to gather clinicopathologic data and follow-up outcomes of     male breast cancer patients diagnosed and/or treated at Salah Azaïz Cancer Institute from     2004 to 2013.      Goal of the prospective part: to create a registry of male patients with breast cancer for a     period of 48 months (from 2014 to 2017).   "
3486|NCT03240302|"     The aim of this research is to compare sibling oocytes using two sperm selection methods for     choosing the best quality spermatozoa before they are injected into oocytes and the influence     of each of these methods on embryo quality and IVF outcome.   "
3487|NCT03240289|"     Diabetes during pregnancy can be a challenging circumstance requiring extensive patient     learning and self-care. The purpose of this study is to develop and pilot test a     patient-centered diabetes education and self-care tool using text messaging to provide     supportive messaging and education to underserved women with a pregnancy complicated by     diabetes.   "
6924|NCT03195244|"     To compare the efficacy of one-on-one versus group-based aquatic therapy on the social     interactions, behaviors and physical activities of children with autism spectrum disorders     (ASDs).   "
3471|NCT03240497|"     Inflammatory cytokines play a pivotal role in rheumatoid arthritis (RA) and innovative     non-pharmacological therapies aimed at limiting cytokine production are highly warranted.     Recently, our group showed that healthy volunteers trained in an intervention developed by     'Iceman' Wim Hof were able to voluntarily attenuate the pro-inflammatory response during     experimental human endotoxemia (a model of systemic inflammation elicited by administration     of lipopolysaccharide [LPS] in healthy volunteers). Subjects trained in the intervention     exhibited profound increases in plasma adrenaline levels, a rapid increase of an     anti-inflammatory cytokine and subsequent attenuation of the pro-inflammatory response.      The intervention consists of three elements, namely meditation, exposure to cold and     breathing techniques. The meditation element is not likely to be involved. It was a very     minor part of the training program and was not practiced during the endotoxemia experiments.     Exposure to cold and the subsequent rewarming to normal body temperature may influence the     inflammatory response through the release of immunomodulatory molecules like HSP-70. Also,     exposure to cold can induce an ischemia-reperfusion-like state in the skin and peripheral     tissue that is known to be involved in the downregulation of pro-inflammatory cytokines and     upregulation of anti-inflammatory cytokines. The investigators anticipate that the third     element, breathing techniques, is the major contributor to the anti-inflammatory effects of     the intervention previously observed. The present study aims to explore the effects of the     breathing technique ('strength ventilation'), the exposure to cold, and these two elements     combined on the immune response during human endotoxemia. Elucidation of the relative     contribution of the elements is of importance to establish a feasible, safe, and effective     intervention for future use in patients.      Objective: The primary objective of the present study is to determine the effects of the     `strength ventilation` breathing technique and exposure to cold, both separately and in     combination, on the inflammatory response during human endotoxemia. To this end, a 2 by 2     design will be employed. Additionally, an evaluation of the influence of the cold exposure     and breathing technique on pain thresholds and oxygen tension in the mitochondria will take     place.   "
3472|NCT03240484|"     Long term functional status   "
3473|NCT03240471|"     Distal radius fracture (DRF) is a common fracture of which the incidence appears to be     increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.      In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment     with plaster cast or brace for one-three weeks. Despite the advice in the guideline and     despite several studies from the 90's showing that plaster cast treatment of a stable DRF for     one week is safe, the usual length of plaster cast treatment for stable DRF is four-six     weeks. In addition, recent studies have also shown that a long period of immobilization can     lead to more post traumatic pain by increasing disuse and kinesiophobia.      This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF     is unnecessary.      The aim of this feasibility study is to define whether one week of plaster cast treatment is     possible and can lead to better functional results, with at least the same patient     satisfaction and complications. In addition, this feasibility study will be used to define     the sample size of the future RCT.   "
3474|NCT03240458|"     Diabetic macular edema is one of the major causes of visual impairment in diabetic     retinopathy patients especially in the working age group. The problem is likely to increase     in the future with statistics showing a growing number of the diabetic population especially     in the Middle East . .   "
3475|NCT03240445|"     This Phase I study in healthy male volunteers will evaluate the impact of the effect of food     on the pharmacokinetic profile of ODM-203.   "
3476|NCT03240432|"     The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve     quality of life in older adults with T1D.   "
3477|NCT03240419|"     This study will assess the feasibility of a randomized control trial in which the effects of     probiotic supplementation throughout pregnancy on maternal insulin sensitivity and     inflammation, as well offspring gene expression and body composition are examined.   "
3478|NCT03240406|"     This is a pilot randomized controlled clinical trial is designed to investigate whether the     Multicultural Healthy Diet (MHD), an anti-Inflammatory diet based on the Dietary Inflammatory     Index tailored to a multi-cultural population, can improve cognitive functioning in a middle     aged (40-65 yr) urban population in Bronx, New York compared to a usual diet.   "
3479|NCT03240393|"     A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult     Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have     received one or two prior lines of systemic therapy for advanced/metastatic disease as     measured by overall response rate (ORR). The study will also evaluate safety and     pharmacokinetics of INC280.   "
3480|NCT03240380|"     This randomized clinical trails compares the influence of joint crisis plans (JCP) or crisis     cards to reduce psychiatric coercion for people with severe and often recurring mental     illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Both     interventions will be carried out as integrated part of otherwise standard psychiatric     in-patient care in clinic stations specializing in acute or non acute treatment of mentioned     mental illnesses.   "
3481|NCT03240367|"     Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with     improvements in minimally invasive surgery. Ensuring patient comfort and early return to life     are the criteria that should be given priority in this treatment method.The purpose of this     study; Emphasizing that the cautery technique of the stapler line bleeding control methods is     as successful as the other methods.   "
3482|NCT03240354|"     In paediatric anaesthesia, use of cuffed endotracheal (ET) tubes is subject to much debate.     The concern is the possibility of damage to tracheal mucosa by excessive pressure from the     cuff. The cuff pressure can increase during anaesthesia, especially if nitrous oxide is used.      Using saline to inflate the cuff has been shown to reduce intra-operative cuff pressure     variation in adult studies, although it is not standard practice. Although the literature     contains reports of cuff pressure increases during paediatric anaesthesia, there are no     reports of attempts to address this. Use of pressure monitoring is recommended by AAGBI, but     may not be consistently done. A safe method of limiting pressure, that is effective, imposes     minimal extra workload and has minimal cost, would reduce risk to patients.      This study aims to investigate the effect on intra-operative cuff pressure of using saline to     inflate the ET tube cuff, compared to standard practice of air inflation. Continuous pressure     monitoring will be used to determine the proportion of cases where interventions are required     to keep the pressure below a safe maximum level.   "
3483|NCT03240341|"     The aim is to implement the Patient Activation Measure in paramedical practices as a tool to     measure activation of patients in cancer care   "
3484|NCT03240328|"     To study the safety and effectiveness of CAR-T Cell Therapy on HIV patients whose plasma HIV     has been successfully suppressed after cART, which is expected to enhance the     res-constitution of HIV-specific immune function to assist the eradication of HIV reservoir.   "
3488|NCT03240276|"     The aim of this research is to compare sibling oocytes using two sperm selection methods for     choosing the best quality spermatozoa before they are injected into oocytes and the influence     of each of these methods on embryo quality and IVF outcome.   "
3489|NCT03240263|"     Failure to wean is a clinical problem and strength training of inspiratory muscles has been     recently proposed as possible additional component of weaning strategies. The main hypothesis     is that inspiratory muscle training improve weaning success rates and abbreviate weaning     duration and ICU length of stay in difficult to wean patients compared to a sham endurance     training group.   "
3490|NCT03240250|"     For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized:     uni-portal and three-portal VATS. In the uniportal approach, the injury on a single     intercostal space could determine a lower level of pain than the three-portal approach,     allowing a better postoperative course. Few studies in Literature compare these techniques,     and most of them are retrospective.      The main purpose of this randomized study is to compare uni-portal VATS with three-portal     VATS, in terms of postoperative pain.      Secondary objectives of the study are valutations of:        -  respiratory and functional capacity between the two groups        -  operative time        -  number of resected lymphnodes        -  intra and postoperative complications, such as conversions to open surgery, amount of          bleeding, prolonged air leaks, surgical site infections, pulmonary complications.   "
3491|NCT03240237|"     This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure     patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or     III symptoms despite appropriate medication.      The terminology of the HF classification HFpEF is based on the 2016 European Society of     Cardiology (ESC) Heart Failure Guidelines.   "
3492|NCT03240224|"     The aim of this study is the synergistic effect of cancer ablation and life information     rehabilitation therapy on unresectable breast cancer.   "
3493|NCT03240211|"     This is a multicenter, multi-arm, international, phase Ib, 3 x 3 dose-escalation study with     an initial phase I followed by an expansion phase. The primary objective of the phase Ib is     to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dose     limiting toxicity (DLT) of various combinations of pembrolizumab, pralatrexate and     decitabine.   "
3495|NCT03240185|"     This is a quality assurance trial to evaluate the effectiveness of guided breathing exercises     on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients. All patients     who undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce     pain and increase relaxation. These patients will be surveyed at their post-operative visit     regarding pain and other symptoms and at their one month post operative visit on the any     hospitalizations and emergency room visits since their surgery.   "
3496|NCT03240172|"     detection of DNA damage due to occupational exposure to low dose ionizing radiation using     comet assay technique and genotyping of certain DNA repair genes to detect inherited     polymorphism.   "
3497|NCT03240159|"     A prospective study of three different doses of Degarelix in late luteal phase of women     undergoing ovarian stimulation for IVF   "
3498|NCT03240146|"     The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has     FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of     the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high     frequency is reported to alleviate pain with no sensation. By randomising patients between     application of an active device or a dummy device and assessment of disability and pain     scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a     major health problem and if effective this has major economic implications as the device is     cheap and safe.   "
3499|NCT03240133|"     This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor,     BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary     angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks)     or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be     assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a     further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if     efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of     BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject     diary entries completed at pre-defined times post-dose.   "
3500|NCT03240120|"     This trial aims at determining if dabigatran is effective in the treatment of malignancy     associated VTE. Tolerance and safety of dabigatran will also be assessed.      This is a single armed trial of dabigatran in patients with malignancy associated VTE.      The target recruitment is 99 consecutive patients with active malignancy and newly diagnosed     VTE (deep vein thrombosis and/or pulmonary embolism) in Queen Mary Hospital.      Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed (duplex     Doppler ultrasonography for deep vein thrombosis, and computed tomography for pulmonary     embolism), and a written consent is obtained. Patients will be switched to dabigatran 150mg     twice daily from day 6 onwards. The first dose of dabigatran will be given within 2 hours     before the time that the next dose of tinzaparin would have been due. Anticoagulation will be     continued as long as malignancy is active. If patients achieve a complete remission of their     underlying malignancies, dabigatran will be continued for 6 months further.   "
3501|NCT03240107|"     to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation     levator aponeurosis Tucking for Congenital Ptosis   "
3502|NCT03240094|"     An optimal nutritional status is essential for healthy ageing. Telemonitoring might     contribute to maintaining or improving nutritional status in elderly people.The objectives of     this effect study are to test the feasibility and effectiveness of telemonitoring of     nutritional parameters in community-dwelling older adults.   "
3503|NCT03240081|"     The purpose of this study is to compare the effectiveness of two low doses of estrogen cream     applied to a new location for the treatment of moderate or severe pain during sexual     intercourse in postmenopausal women.   "
3558|NCT03239353|"     This is a phase 1, randomized, partially-blind, parallel group, active and placebo controlled     study to evaluate the PK and safety of single oral doses of ETV XR tablet in healthy     subjects.      Approximately 40 healthy volunteers will be enrolled in this study. Eligible subjects will be     randomized 1:1:1:1:1 to the following treatment groups, respectively:        -  Cohort 1 (Blinded): 1.5 mg ETV XR tablet        -  Cohort 2 (Blinded): 3 mg ETV XR tablet        -  Cohort 3 (Blinded): 6 mg ETV XR tablet        -  Cohort 4 (Blinded): Placebo-to-match 1.5 mg ETV XR tablet        -  Cohort 5 (Open-label): 0.5 mg ETV IR tablet   "
3504|NCT03240068|"     Peripheral arterial disease (PAD) affects over 8 million individuals in the United States     alone. This is a form of atherosclerosis in which plaques preferentially build up inside the     arteries of the legs to limit blood flow. These patients are at high risk for heart attack     and stroke, with at least half dying from coronary artery disease. Our understanding of the     causes of PAD remains incomplete. The renin-angiotensin hormone system is one mechanism known     to contribute to atherosclerosis. Pharmacologic blockade of the hormone angiotensin II is     beneficial in forms of atherosclerosis, including peripheral arterial disease, to improve     blood vessel damage and functional outcomes. These therapies also increase circulating levels     of angiotensin-(1-7), a hormone that dilates blood vessels. Angiotensin-(1-7) improves blood     vessel function and reduces inflammation to protect against atherosclerosis in animal models;     however, there are no clinical data in patients with atherosclerosis. The overall goal of     this project is to examine the cardiovascular effects of angiotensin-(1-7) in PAD.   "
3505|NCT03240055|"     The purpose of this study is to investigate the effect of spinal anesthesia on ED50 and BIS50     of etomidate for the loss of consciousness (LOC) by using up-and-down method.Our hypothesis     was that spinal anesthesia could significantly reduce the etomidate bolus dose for the LOC     and could also achieve hemodynamic stability during anesthesia induction.   "
3506|NCT03240042|"     When the retractor blades oped and is positioned to provide the surgical access in the     anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure     on the tissue between the retractor and the trachea. This is convincible as revealed by the     increase of cuff pressure of endotracheal tube. The study aims to investigate differences in     the increase of cuff pressure after retractor is positioned between nasotracheal and     orotracheal intubation.   "
3547|NCT03239496|"     The study will assess and compare the immune response to full-dose inactivated polio vaccines     (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated     poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule     combinations in the Expanded Program on Immunization (EPI) primary series.   "
3548|NCT03239483|"     The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine     gel (0.05%) administered rectally to HIV-1 seronegative adults.   "
3649|NCT03238157|"     Radiation retinopathy is a known complication of ocular radiation therapy. To date there is     no known effective treatment. In addition to their anti-vascular endothelial growth factor     (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing     the activity/density of tight junctions and acute inflammatory effects of radiation in     various tissues.   "
3507|NCT03240029|"     Few data about the evaluation of consequences of past life with cancer on life quality of     children in school reintegration are available in literature. Nevertheless, some of these     studies show that the reintegration impairs life quality of these children (school     difficulties, conflictual relations with peers…). The hypothesis is that children with past     life with cancer have more chances to have school integration difficulties with a consequent     life quality degradation compared to healthy children.      The main objective of this project is to study the relation between the satisfaction of     school reintegration of children in cancer remission and the evolution of life quality in the     medium term (after getting back to school). More exactly, it is the question if the     satisfaction of school reintegration influences life goals and priorities of these children.      The secondary objective is to study the role of psychological status of these children     (anxiety, depressive symptoms) on satisfaction-life quality relation.      A group of children with cancer history sent to ordinary school is compared to a control     group of children sent to school in the same conditions (sex and age matched). Data are     collected with questionnaires some months to several years after school reintegration and     same questionnaires 1 year later.      If the study hypothesis is confirmed, this study will show the necessity of a long term     follow up of children in cancer remission and not only medical care, but also psychological     and social care, in order to support a better school reintegration.   "
3508|NCT03240016|"     This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1     (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer.      Each cycle last 21-days. All subjects will receive abraxane via IV on Day 1 and Day 8 of each     cycle. Subjects will either receive pembrolizumab (IV) on Day 1 of each cycle. Subjects may     continue to receive the study regimen until they experience disease progression or     unacceptable toxicity.   "
3510|NCT03239990|"     According to studies, approximately 20% of children having contact with child protection     services have conduct disorder. Negative parenting can make this problem even worse. Research     has shown Incredible Years Program to be one of the most effective programs to prevent and     reduce child conduct problems. This study is an randomized controlled trial, which evaluates     the suitability and effectiveness of group-based Incredible Years program in child protection     and family support services. The aim of this study is to find out whether this intervention     reduces children's psychiatric symptoms, especially conduct symptoms, increases positive     parenting and positive interaction between parents and children, and reduces children's and     parent's stress and increase well-being. The study will be carried out in 2015-2018. Overall     101 children and 120 parents participate in the study.   "
3511|NCT03239977|"     This study is a randomized clinical trial designed to compare an online social intelligence     intervention with an active control condition at improving the emotional, physical, and     social well-being of custodial grandmothers and their adolescent grandchildren,   "
3512|NCT03239964|"     Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent     keloid at site of surgical scar. One group will undergo surgical excision of keloid. The     other group will have combined surgical excision of keloid and single intralesional     dexamethasone injection at edges of wound.All patients were reviewed once per month for 6     months for evidence of recurrence   "
3513|NCT03239951|"     Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.      A total of 44 eligible subjects will be randomized into the study to receive treatment with     either re-catheterization OR with iTind implantation using a 1:1 randomization scheme     stratified by center.      Study duration will be 12 months post implantation, with follow-up extension of up to 3     years. Extension of follow up period will not require an additional ICF.   "
3514|NCT03239938|"     Modern pain neuroscience has advanced our understanding of chronic whiplash associated     disorders (WAD). Previous studies have shown the importance of central sensitization,     characterized by hypersensitivity of the somatosensory system, in explaining poor treatment     outcome. Therefore, and to address the need for a better treatment of chronic WAD, we     recently proposed a modern neuroscience approach to chronic WAD. Such approach includes two     specific parts: therapeutic pain neuroscience education followed by dynamic and functional     cognition-targeted exercise therapy and stress management techniques.      The primary scientific objective of the study entails examining the effectiveness of a modern     neuroscience approach versus usual care evidence-based physiotherapy for reducing     dysfunctioning in patients with chronic WAD. The secondary scientific objective of the study     entails examining the effectiveness of a modern neuroscience approach versus usual care     evidence-based physiotherapy for reducing pain, central sensitization, psychosocial problems,     and socio-economic burden in patients with chronic WAD. The trial will randomize 120 patients     with chronic WAD, aged between 18 and 65 years, to the experimental (modern pain neuroscience     approach including 3 sessions of therapeutic pain neuroscience education followed by 15     sessions of dynamic and functional cognition-targeted exercise therapy and stress management     techniques (n = 60)) or the control treatment (usual care physiotherapy including 3 sessions     of neck school followed by 15 sessions of graded and active exercise therapy focusing on     strength, flexibility, endurance, and ergonomic principles (n= 60)). The primary outcome     measure is self-reported functional status. Secondary outcome measures include pain,     health-related quality of life, psychological correlates, measures of central sensitization,     and socio-economic factors. In addition, quantitative scalp Electroencephalography (EEG) to     measure various parameters of brain activation will be performed during a conditioned pain     modulation paradigm. Baseline assessment of all outcome measures will be performed.      Follow-up assessments will be performed immediately after 16 weeks of therapy (all tests),     and 6 months (all tests) and 12 months (only questionnaires) after finishing the therapeutic     intervention.      To investigate these objectives, a multi-center triple-blind randomized, controlled trial     with 1 year follow up will be performed.   "
3515|NCT03239925|"     To investigate the acute effects of cell phone exposure on immediate attention levels and     concentration of emergency department physicians   "
3516|NCT03239912|"     This experimental study will evaluate the effect of combined treatment with low-level laser     and functional appliances (twin-block) on the correction of Class II malocclusion, compared     with the control group treated with functional appliances (twin-block) only.      The study sample will consist of 40 patients with Class II malocclusion. The sample will be     allocated randomly into two groups: a control group and an experimental group.      Functional appliance (twin-block) will be applied for all patients. Low-level laser will be     applied for the experimental group only. The skeleto-dental changes occurring after     functional treatment will be assessed using cephalometric radiographs; pre- and post-     treatment changes for each group will be evaluated individually.   "
3580|NCT03239067|"     This is a prospective, single-center study to assess the long- and short-term outcomes of     ticagrelor vs clopidogrel in Chinese patients with acute coronary syndrome undergoing     percutaneous coronary intervention.   "
3581|NCT03239054|"     This study is a randomized controlled parallel arms trial. The purpose of this study is to     evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.   "
3518|NCT03239886|"     This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic     phase that sustain major molecular response after imatinib discontinuation. To be eligible     for this protocol, the subject must have received imatinib as first line regiment for at     least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.   "
3519|NCT03239873|"     This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella     Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with     the VARIVAX™ 2016 commercial process. The primary hypotheses being tested are that antibody     response rate and mean antibody titer induced at 6 weeks after a single vaccination by     VARIVAX™ PE34 Process are non-inferior to those induced by VARIVAX™ 2016 commercial process,     and that antibody response rate induced by VARIVAX™ PE34 Process is acceptable.   "
3520|NCT03239860|"     The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human     endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical     role in multiple sclerosis.      The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term     efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease     progression.   "
3521|NCT03239847|"     This study aims to compare the time difference between radial arterial line placement and use     of the EndoPhys sheath, as well as, assess the cost effectiveness of the EnoPhys sheath vs.     use of a radial arterial line based on device and operating room costs.   "
3522|NCT03239834|"     Objectives Validate the OncAlert RAPID Test, with an NPV ≥(1-prevalence).      Evaluate the independent and associated contribution of readily available clinical variables     including age, race, gender, HPV status, socioeconomic level, tobacco, and alcohol use with     the biopsy and test results.      Evaluate OncAlert RAPID Test results in patients without immediate biopsy, both at baseline     and scheduled follow-up visit (approximately 1-3 months), to assess impact on outcome.      Planned Number of Subjects 800 patients will be followed until pathology of clinically     directed incisional / diagnostic biopsy pathology report is received.      An additional 200 'non-biopsy subjects' will be followed then re-evaluated during a 1-3 month     clinic visit.      Additional follow up of subject data may continue for up to 2 years. Patient Population      Cohorts 1a and 1b:      Subjects with a clinical suspicion of oral potentially malignant disorders, oral or     oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical     history, suspicious lesion(s) in mouth without history of a prior biopsy.        -  Cohort 1a: oral cavity        -  Cohort 1b: oropharynx      Cohort 2:      Subjects with clinically indicated suspicion of disease but without immediate biopsy, both at     baseline and scheduled follow-up visit (approximately 1-3 months), Screen Fail Rate A 20%     Screen Fail Rate is anticipated. Investigational Product Name OncAlert Oral Cancer RAPID Test     (OncAlert RAPID) Methodology Overview Prospectively collect 5cc of normal saline after a     combination of swish, gargle and spit into the provided collection specimen cup. Specimens     will be collected at baseline (time of biopsy) as per standard practice at each site. The     OncAlert RAPID Test cassette is inserted into the specimen cup and read directly from the     cassette in 10 minutes. In addition, comprehensive clinical - pathology and patient     demographic features including age, gender, race, ethnicity, and all pathology biopsy results     will be collected. Any pertinent additional clinical data including HPV status, socioeconomic     status, smoking, drinking history, and pertinent features related to oral health will be     obtained. A central pathology review for all biopsy results will be performed and     incorporated into the final analyses.   "
3523|NCT03239821|"     The primary aim of this investigation is to assess the safety, feasibility and performance of     the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will     also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric     motility and emptying. Furthermore, this investigation will examine whether gastric motility     and emptying as measured in this study are correlated.   "
3559|NCT03239340|"     A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR     mutation-positive locally advanced or metastatic NSCLC treated with osimertinib   "
3609|NCT03238690|"     The purpose of this study is to investigate the potential recovery of heart function in     end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD)     through applying a myocardial conditioning protocol. During myocardial conditioning, LVAD     speed is reduced gradually in order to increase the work load of the heart. Multiple previous     studies have shown that interventions like this may improve heart function and give patients     the opportunity for a better quality of life.   "
3524|NCT03239808|"     Assisted conventional HD in a health center is the most used treatment for stage 5D CKD in     the whole world. By definition it is performed in an outpatient setting 3 days a week for 3     to 5 hours. However, this treatment has an unacceptable high mortality rate (10%-20% a year).     This fact has been assigned, among other things, to an insufficient depuration of uremic     toxins. In order to try to improve those results, new HD techniques and programs have been     proposed. They are based on an increase of the dose as well as on the number of sessions,     regarding the conventional HD used. Nevertheless, inconsistent results of such programs in     terms of clinical benefits have been shown in recent controlled and randomized trials.     Besides, a higher number of sessions has been associated to a lower rate of vascular access     success and to a more accelerated loss of the RRF due to an increased exposure of the blood     to the dialyzer membrane, together with frequent episodes of low blood pressure.      RRF contributes, among other things, to the homeostasis maintenance of the internal     environment, to the endogenous production of vitamin D and erythropoietin and to the     elimination of protein-bound uremic toxins which are poorly dialyzed. Thus, the maintenance     of RRF in patients who start renal replacement therapy (RRT) with HD must be a basic     objective since it plays a fundamental role not only in the dialysis adequacy, but also in     the quality of life and in survival.      The National Kidney Foundation-Kidney disease Outcomes Quality Initiate (NKD KDOQI 2015)1     guidelines set the improvement of the quality of life and the patient's survival as the final     objective of the RRT. It also distinguishes between appropriate dialysis and the proper care     of the patient on dialysis. For patients with a significantly high RRF, measured by a renal     clearance of urea (KrU) higher than 3ml/min/1.73m2, reducing the dose of dialysis or the     frequency of sessions per week is suggested. In such cases a proper target is estimated to     achieve a standard Kt/V (stdKt/v) of 2.3 volumes per week, including the renal clearance and     the ultrainfiltration. However, in spite of the fact that more than 50% of the patients who     start RRT have a KrU higher than 3 (ml/min/1.73m2) 13, few centers follow such     recommendation.      Incremental or progressive HD is an initiation regimen adapted to the patient's necessities     and his/her RRF. It begins with a low frequency of dialysis which increases gradually as the     diuretic level and RRF decline.   "
3659|NCT03238027|"     A Phase 1 dose escalation study to determine if SNDX-6352 will be sufficiently safe and     well-tolerated at biologically active doses to warrant further investigation in patients with     solid tumors.   "
3525|NCT03239795|"     Most of family physicians (FPs) use advertising in their waiting rooms in order to educate     patients. Our objective was to assess an advertising campaign for influenza vaccination using     posters and pamphlets in FPs' waiting rooms.      Registry based 2/1 cluster randomized controlled trial. Clusters gathered the listed patients     over the age of 16 of 75 randomized FPs. The trial was conducted during the 2014-2015     influenza vaccination campaign. Intervention group, 25 FPs received and exposed in their     waiting rooms pamphlets and one poster promoting the influenza vaccination campaign (added to     the usual mandatory information). Control group (50 FPs), usual waiting room. The main     outcome was the number of vaccination units delivered in pharmacies. Data were first     extracted for 2013-2015 from the SIAM-ERASME claim database of the Health Insurance Fund of     Lille-Douai (Northern France). The association between the intervention and the main outcome     was assessed trough a generalized estimating equation.   "
3526|NCT03239782|"     The prevalence of overweight and obesity in Singapore is approximately half of that in the     United States, yet the incidence of type 2 diabetes is similar, and is expected to double in     the near future. This indicates that metabolic dysfunction, particularly insulin resistance,     is widely prevalent even among individuals who are considered normal-weight or lean by     conventional measures, i.e. body mass index (BMI) and percent body fat. These individuals are     often referred to as metabolically-obese normal-weight (MONW), and have increased risk for     cardiometabolic disease despite their normal BMI and total body fat values. The prevalence of     the MONW phenotype varies across populations and differs markedly among different     ethnicities. However, our understanding of the complex interactions between ethnicity, body     composition, and metabolic dysfunction and its reversal remains rudimentary. Previous     attempts to characterize the MONW phenotype are confounded by the small but significant     differences in BMI or percent body fat between groups (even if all subjects were lean, within     the normal range), with MONW subjects being always fatter than the corresponding control     subjects. There are no published studies that prospectively recruited groups of metabolically     healthy and unhealthy lean individuals matched on BMI and percent body fat. Furthermore,     although weight loss improves body composition and many of the cardiometabolic abnormalities     in most obese patients, little is known about the possible therapeutic effects of calorie     restriction in MONW subjects.      Accordingly, a better understanding of the MONW phenotype and the evaluation of therapeutic     approaches for its reversal will have important implications for public health. By     facilitating earlier identification of these subjects, who are more likely to go undiagnosed     and thus less likely to be treated before clinically overt cardiometabolic disease develops,     results from this study will allow for earlier and effective intervention.   "
3527|NCT03239769|"     One hundred twenty female patients who underwent thyroidectomy were evenly distributed into     three groups: conventional access (CA), aesthetic principles access (APA) and minimally     invasive access (MIA). The Patient and Observer Scar Assessment Scale (POSAS) was used as the     assessment tool for the linear scar. After one year follow-up, the cosmetic outcomes were     assessed.   "
3528|NCT03239756|"     This is a single-center, open-label, dose-escalating study to evaluate the safety,     pharmacokinetics, immunogenicity, and preliminary efficacy of single and multiple     subcutaneous injection TK006 in patients with breast cancer-related bone metastases.   "
3529|NCT03239743|"     Pain and anxiety have a direct correlation. Patients who experience anxiety are more     susceptible to feeling pain, and patients who experience pain are more likely to have a     component of anxiety associated with their pain. A common technique used by pain     psychologists to help minimize pain is distraction. Different forms of distraction include     video games, movies, music, etc. Recently, doctors and researchers around the world have     begun experimenting with Virtual Reality as a distraction technique.      A review of the use of virtual reality compared to the current standard of care may help     uncover important trends regarding anxiety, postoperative pain and analgesic use in patients     who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.   "
3530|NCT03239730|"     This study evaluates the prognostic value of arterial blood gas analysis in a cohort of     Emergency Department patients presenting with shortness of breath of any cause, comparing     obese and non-obese patients.   "
3531|NCT03239717|"     Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from     proteins found in food, especially meat, diary products, and legumes. Data from rodent     studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved     control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs     without reducing calorie intake will lead to similar metabolic benefits in humans. Here the     investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement     beverages for two months.   "
3576|NCT03239119|"     This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type     2 Diabetes Mellitus will be enrolled in the trial.   "
3577|NCT03239106|"     Chronic Itch is a debilitating condition affecting many people. Currently, there are no     FDA-approved treatments. Apremilast is an FDA-approved oral medication used to successfully     treat the inflammatory skin disorder psoriasis and the inflammatory disorder psoriatic     arthritis. This study examines if apremiliast taken twice daily relieves chronic itch.   "
3578|NCT03239093|"     To assess 16-year trends in undernutrition reporting and management in Switzerland   "
3532|NCT03239704|"     Inflammatory Bowel Diseases (IBD) refers to a category of disorders, consisting of Crohn's     Disease (CD) and Ulcerative Colitis (UC), where segments of the gastrointestinal tract become     inflamed and ulcerated. Canada has among the highest incidence rates of IBD in the world -     16.3 and 12.3 per 100,000 for CD and UC respectively. In the absence of a cure, the current     goal of treatment is to manage patients in a milder state of remission. However, maintaining     (or even achieving) remission is dependent on timely access to specialist IBD care; which in     light of rising incidence rates have proven to be challenging. Moreover, patients often     experience flare-ups of their gastrointestinal symptoms, while awaiting access to specialist     care. In recent years, there has been increased integration of telemedicine services in     gastroenterology practice. This change has been driven by a desire among IBD patients to have     more flexible follow-up care, where 'virtual' care is provided as an adjunct to in-person     consultations. Within the context of IBD, telemedicine might be effective in delivering     routine and timely follow-up care to high-risk patients. The purpose of this study to     determine whether telemedicine-based follow-up care can effectively manage the     gastrointestinal symptoms of high-risk IBD patients and reduce their need for preventive     health care services.   "
3533|NCT03239691|"     The main study objective is to assess the effect of ACT-709478 in male and female subjects     with photosensitive epilepsy following single dose administration   "
3534|NCT03239678|"     The use of 100% oxygen during the induction of general anesthesia is always preferable in     order to have enough time to secure the airway by endotracheal intubation, because     preoxygenation with a low oxygen concentration may reduce the safe time for apnea. However,     using a low oxygen concentration during preoxygenation might prevent the formation of     atelectasis. There is still no clear conclusion about the best oxygen concentration for     preoxygenation. Our study is designed to evaluate the safety of preoxygenation with whether     30% or 21% oxygen by the safe time for apnea during the induction of general anesthesia.   "
3837|NCT03235661|"     The investigators compared advantages and disadvantages of two forms of noninvasive     respiratory support —bi-level positive airway pressure(BiPAP) or nasal continuous positive     airway pressure (nCPAP) —as a primary mode of ventilation in preterm twins infants with     respiratory distress syndrome   "
3535|NCT03239665|"     The study consists of two arms (PHARM and PEER) designed to educate participants about three     vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will     consist of a 60-minute presentation about the three vaccine-preventable diseases and their     vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion     supplemented by video clips of community members discussing their experiences around     vaccination, as well as physicians underscoring the importance of vaccination. PEER will     consist of a 60-minute small-group session led by a peer educator which includes scripted     roleplaying exercises designed to reinforce learnings pertaining to these three     vaccine-preventable diseases and their vaccinations. The components of these interventions     will be designed to address specific barriers to vaccination identified by literature search     and our prior work in the area of community-based vaccine education. Both arms will focus     primarily on pneumococcal disease and zoster but will include limited content on influenza     because participants are likely to have questions about how the flu and its vaccination     differ from pneumococcal diseases and zoster. The study will be implemented in an older,     predominantly African-American (AA) population, consistent with our prior work in this area.   "
3536|NCT03239652|"     In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy     and safety of microspheres (T-ACE Beads).   "
3537|NCT03239639|"     Sometimes people with health conditions become ill suddenly and can no longer speak for     themselves and another person (such as a family member) will make health care decisions for     them. This means it is important to think about your wishes and tell others about them. This     is called advance care planning. When people have done advance care planning, if they become     very sick and cannot speak for themselves they are more likely to get the kind of health care     they want and it is easier for the people who make decisions for them. There are tools such     as brochures, questionnaires, and videos that can help people learn about these things. This     research is being to done to study whether using tools for advance care planning and goals of     care discussions will improve how patients and their substitute decision makers do advance     care planning. This study is a randomized trial. This means half of the people in this study     will meet with someone at their family practice to talk about advance care planning and     review some tools and half will get usual care (a pamphlet). The study will 1) evaluate if     reviewing the tools, and having help to complete them, helps patients and their substitute     decision maker do advance care planning 2) if this intervention will encourage patients to     talk to their family doctor about these issues.   "
3540|NCT03239600|"     This study aims to evaluate the safety, tolerability and PK of repeat dose administration of     GSK2618960 in the treatment of pSS. The study will contain two parts, Part I will be open     label and Part II will be randomized, double-blind. The minimum duration of Part I & Part II     of the study will be 26 and 32 weeks respectively.   "
3541|NCT03239587|"     The goal of this research study is to learn if simulated live piano music can change the     amount of stress felt in patients with cancer before surgery, health care providers caring     for cancer patients, and/or hospital volunteers.   "
3542|NCT03239561|"     The primary objectives of this study are to characterize [18F]molecular neuroimaging     (MNI)-1020, a positron emission tomography (PET) radioligand for imaging tau pathology, to     visually and quantitatively assess and compare brain uptake and pharmacokinetics of     [18F]MNI-1020 in participants with probable Alzheimer's disease (AD) and compare with age     matched healthy participants, to evaluate the safety of a single injection of [18F]MNI-1020     and to compare the distribution of tau (using [18F]MNI-1020) and amyloid beta (using     florbetapir) in participants with probable AD.   "
3543|NCT03239548|"     A Study to assess the Opinion of Doctors, Nurses and Key informants regarding Independent     Nurse Midwifery Practitioner at selected Hospitals and Colleges of nursing in Haryana.   "
3544|NCT03239535|"     The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem     cells for the treatment of critical limb ischemia.   "
3579|NCT03239080|"     To evaluate the effects of denosumab on erosion healing and change in physical function in RA     patients.   "
3545|NCT03239522|"     Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in     previous clinical trials; however, the elimination routes and metabolic pathways of     daprodustat have not been fully elucidated in humans. This is an open-label, single-center,     non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male     participants. The aim of the study is to assess the excretion balance of daprodustat using     [14C]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion,     administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose).     Absolute bioavailability of an oral dose will also be assessed. Each participant will be     involved in the study for up to 10 weeks which include a screening visit, two treatment     periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral     doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The     primary objective of the study is to gain a better understanding of the compound's excretory     and metabolic profile. This study will include sampling of duodenal bile to conduct     qualitative assessment of drug metabolites in this matrix in order to characterize biliary     elimination pathways.   "
3546|NCT03239509|"     Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to     national data of the Spanish Society of Thoracic and Cardiovascular Surgery).      There is conflicting evidence regarding the long-term survival of patients aged 50-65 years     with mechanical (M) or biological (B) aortic prostheses. General consensus of greater     complications associated with the use of long-life anticoagulation in M and of reoperation in     B.      Similar survival with lower MACCE complications in bioprosthesis could reconsider their     choice in patients aged 50-65 years, specially in the current TAVI era.      The investigators are going to perform a multicentric retrospective observational study     (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve     Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 5 Cardiovascular Surgery     Centers in Andalousia (south Spain)   "
3549|NCT03239470|"     T cells, a type of white blood cell called a lymphocyte, play an important role in the immune     system. One subtype, the regulatory T cell (Treg) helps to regulate the immune system and may     provide protection against the development of autoimmune disease. The hope is that these     naturally occurring Treg cells can be utilized for the treatment of autoimmune disease and     potentially replace the use of chronic immunosuppressive therapies that are associated with     multiple side effects. There has been a small study showing safe administration of Tregs with     decreased disease activity in patients with insulin-dependent diabetes. Tregs are being     studied in lupus, cancer and organ transplantation.      This phase I trial will be conducted as an open-label, dose-escalation, multicenter trial in     adult participants with active pemphigus.The purpose of this study is to test the safety and     effect of Treg therapy in participants who have skin (cutaneous) involvement due to     pemphigus.   "
3550|NCT03239457|"     The purpose of this study is to assess the efficacy and safety of the intralesional     administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard     treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.   "
3551|NCT03239444|"     This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system     ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation     ablation procedures.   "
3552|NCT03239431|"     This is a prospective cohort study that aims to determine the current demographics, clinical     characteristics, comorbidities, treatment status and exacerbations of asthma patients.      The primary objective of this study is to determine the current demographics, clinical     characteristics, comorbidities, treatment status and exacerbations of asthma patients.      The secondary objectives include: (1) to review the current practices of symptom control     assessment, (2) to determine the choice of pharmacological regimen, rate of guideline     adherence and real-world clinical practice in managing asthma patients, (3) to evaluate the     pattern of lung function parameters (spirometry and forced oscillometry technique [FOT]) in     adult asthma patients, (4) to evaluate the effect of ageing on the trend of change in lung     function parameters (spirometry and FOT) in adult asthma patients, (5) to identify biomarkers     that help to categorize different asthma phenotypes and predict subsequent prognosis, (6) to     determine the risk factors of uncontrolled asthma and asthma exacerbation, (7) to evaluate     the impact of comorbidities on asthma control.      400 out-patient asthma patients are planned to be recruited and they will be followed up for     3 years.   "
3553|NCT03239418|"     Traumatic brain injury, stroke and other neurological conditions may result in weakness of     the muscles that either open or close the eye. This is generally a result of impaired     functioning of the oculomotor or facial cranial nerves. Current treatments to improve eye     opening or closing are either invasive or largely ineffective. This study tests a noninvasive     means of improving eyelid opening and closing by applying a previously demonstrated safe and     effective neuromuscular electrical stimulation (NMES) intervention to the muscles controlling     eyelid movement. Participants in this study will either receive the investigational NMES     protocol 30 min per day for five days or a sham NMES for the same period. The primary outcome     for this study is the participants' ability to open or close their affected eye. Secondary     outcomes include additional measures of eye and corneal health.   "
3554|NCT03239405|"     Comparing the operation times and staple loads used between the use of multiple tubes and a     bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.   "
3555|NCT03239392|"     This study is an open-label, multi-center, dose-ranging study to characterize the safety,     tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered     weekly by IV infusion to adults diagnosed with Large Granular Lymphocyte (LGL) Leukemia or     refractory Cutaneous T-cell Lymphoma (CTCL).   "
3556|NCT03239379|"     This study is a single-center, randomized, single‑blind, placebo (PBO)-controlled,     multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1     administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week     (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be     enrolled in the trial. Participants will be followed for 4 weeks after the last dose for     safety monitoring, and collection of PK and PD samples.   "
3557|NCT03239366|"     This study will be conducted at the Montreal Heart Institute and should involve 130 Type 2     diabetes subjects. Subjects will be randomized in a 1:1 ratio to receive either Bio-K+50B®     probiotic capsules or a matching placebo.   "
3560|NCT03239327|"     Project summary:      Objective: To test the hypothesis that administration of vaginal Misoprostol before elective     cesarean section will improve the neonatal respiratory outcomes in late preterm and early     term neonates through induction of catecholamine surge.      Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university     hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two     hundred and ninety two women will be randomly allocated to receive either 50 micrograms of     Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or     receive nothing (control group; n = 146) .      Main outcome measure: Apgar score at 1 and 5 minutes.   "
3561|NCT03239314|"     The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal     block with and without dexamethasone when added to bupivacaine on the duration of     postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament     reconstruction surgery using Numeric Rating Score (NRS).   "
3838|NCT03235648|"     Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced     ovarian cancer   "
3562|NCT03239301|"     Study design: Controlled Trial Objective: To evaluate the effectiveness of robotic-assisted     training of forearm and hand functions in spinal cord injury patients Setting: Ankara     Physical Medicine and Rehabilitation Training and Research Hospital, Turkey Methods: Forty     patients were allocated into robotic and control groups. Both groups received conventional     rehabilitation program for four weeks. Moreover, robotic group received robotic     rehabilitation program tailored to the patient five times a week (each session of 30 min).      Baseline data and post-intervention data was compared.   "
3563|NCT03239288|"     The objective of this trial is to evaluate the postprandial glucose and insulin responses to     replacing digestible carbohydrates with resistant starch type 4 (RS4) in a baked product in     healthy men and women. A randomized, double-blinded cross-over study will be conducted     comparing two foods (a reference food and a test food). The primary outcome variable will be     the incremental area under the curve (iAUC) for capillary glucose from pre-product     consumption (average of t = -15 and -5 min) to 120 min (iAUC0-120 min). This study will     provide substantiation for a beneficial reduction in glycemic response followed by the     consumption of the active product containing an efficacious dose of resistant starch type 4     (RS4).   "
3564|NCT03239275|"     The purpose of this study is to compare the effectiveness and efficiency of labial versus     lingual biocreative therapy in achieving en masse retraction of the maxillary anterior teeth     in subjects with class II malocclusion requiring upper first premolar extraction.   "
3565|NCT03239262|"     The aim of our study was to investigate, whether enhancement of left atrial cryoablation by     ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of     surgical treatment of atrial fibrillation in patients with structural heart disease     undergoing open-heart surgery.   "
3566|NCT03239249|"     The aim of this study is to analyze whether and how a systemic school-level approach to     dropout prevention (the IKO-model), increase the completion rate from upper secondary school.     The hypothesis is that schools that implement the model (i.e. randomized to the experimental     group), will reduce the amount of students in risk of dropout, compared to their counterparts     in schools randomized to the control group. The main expected outcomes in the study are; 1)     increased amounts of students in upper secondary education completing their education within     the three-year standard length of education, 2) decreased amounts of school-drop out, and 3)     reduced values in mediating variables, such as low achievement, course failures, lack of     attendance and lack of school-motivation and -effort. Accordingly, implementation quality and     fidelity to the model will be assessed, both with quantitative (survey) and qualitative     (interviews and observation) data. A total of five counties and 42 upper secondary schools     participate in the evaluation project. One of the counties (Akershus County) have developed     and piloted the model and function as a mentor in the other four counties (Oppland, Hedmark,     Nord-Trøndelag and Hamar). While 20 schools have been randomized to the experimental group,     22 schools have been randomized to the control group. Schools randomized to the control group     will work as earlier with school dropout.   "
3567|NCT03239236|"     This study investigates the effect of 4 different methods of rapid sequence induction (RSI)     in morbidly obese patients on the amount of air insufflation into the stomach.   "
3568|NCT03239223|"     This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical     precancerous lesions in adult women.   "
3569|NCT03239210|"     This project investigates the use of 4 weeks of 24 mg/day ondansetron as compared to placebo     on symptoms and brain functioning in patients with obsessive-compulsive disorder (OCD) and     tic disorders (TD). Patients will be randomized to receive ondansetron or placebo for 4     weeks, with MRI scans and symptom assessments occurring at baseline (before any drug) and at     the end of the 4 weeks. Patients will also be asked to come into the lab approximately 2     weeks into the trial for symptom assessments. The investigators hypothesize that after 4     weeks there will be greater reduction from baseline in sensory symptoms and the activation of     the insula and sensorimotor cortex compared for ondansetron as compared to placebo.   "
3570|NCT03239197|"     This is an exploratory study designed to collect microbial samples from several body     locations from 6 pairs of mothers and their newborn infants at various time points.   "
3571|NCT03239184|"     The aim of this study is the synergistic effect of cancer ablation and life information     rehabilitation therapy on unresectable pancreatic cancer.   "
3572|NCT03239171|"     The aim of this study is the synergistic effect of cancer ablation and life information     rehabilitation therapy on unresectable lung cancer.   "
3573|NCT03239158|"     The aim of this study is the synergistic effect of cancer ablation and life information     rehabilitation therapy on unresectable liver cancer.   "
3575|NCT03239132|"     The purpose of this study is to establish the feasibility and acceptability of a breath-based     meditation in stroke survivors with post-stroke depression (PSD) and their informal     caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis     is that the breath-based meditation will lead to decreases in the severity of symptoms of     PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in     plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and     their informal caregivers.   "
3582|NCT03239041|"     Social determinants of health affect patients throughout the life course. They may be     particularly relevant for pediatric emergency department (ED) patients. Computerized     screening for social and behavioral determinants of health has been deemed effective and     acceptable. This pilot study will characterize the cumulative burden of health related social     problems experienced by patients and families in a pediatric ED. It will specifically examine     those patients with a subset of 9 high-risk chief complaints, patients with obesity, patients     with poor asthma control, and patients with a high number of non-urgent visits, who may be at     particularly high risk for health related social problems. Our analysis will compare these     subsets of patients with the general ED population, hypothesizing that these groups will have     a higher number of health related social problems than the general ED population. Parent and     adolescent participants will be approached during ED visits and administered a computerized     screening tool. For patients aged 0-13, a survey administered to parents will test for     thirteen distinct health related social problems. Two surveys will be administered to     adolescent-parent dyads. The adolescent survey will test for thirteen health related social     problems, seven of which overlap with those on the parent survey. The average total number of     health related social problems in patient groups hypothesized to be at high risk will be     compared to the average total number of HRSPs in the general ED population. For adolescent     patients, an intervention group will receive social navigation consisting of rapid referrals     to community resources based on survey responses by a community health liaison. Their ED     recidivism, community resource use and number of unmet social needs at 12-month follow up     will be compared with that of a control group that receives screening and written resources     only.   "
3583|NCT03239028|"     We will examine the association between diet quality in offspring at age 14 years and     maternal diet quality during pregnancy in the Danish National Birth Cohort   "
3584|NCT03239015|"     This study is intended to evaluate efficacy and safety of targeted precision therapy in     patients with refractory tumor, including rare tumor without standard recommended treatment     and common tumor after multiple line of therapy.   "
3585|NCT03239002|"     This is the first study with a real diagnostic and prognostic focus in prenatal. In addition     to this innovative aspect, the identification of cryptic imbalances in fetuses with     malformative syndrome would be an invaluable resource for the identification of new genes     involved in development, as is already the case for postnatal studies.      This research aims to:        1. to test the feasibility of this protocol, ie the practical application of this new          technology in the context of prenatal diagnosis,        2. demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities          in fetuses with a thick neck associated with other malformations and recruited on the          strict criteria mentioned above,        3. assist in the diagnosis of these fetuses and genetic information for their families,        4. identify new regions of the genome potentially involved in the occurrence of congenital          malformations.   "
3586|NCT03238989|"     The purpose of this study is investigating the clinical course, treatment course, and     prognosis of patients with interstitial lung disease.   "
3587|NCT03238976|"     Patients will be randomly assigned to one of two groups: the group exposed to NS, or the     standard care group exposed to supportive dialogue. Patients assigned to the former group     will be exposed to continuous NS throughout the CNB procedure.   "
3588|NCT03238963|"     The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335     as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in     patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47)     or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without     Center-involved diabetic macular edema (CI-DME)   "
3589|NCT03238950|"     This study will assess whether the type of simulation model used in cricothyroidotomy     training has an effect on the subsequent confidence and competence in the procedure.   "
3590|NCT03238937|"     The study objectives are to demonstrate the ease and safety of bilateral cervically implanted     phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To     demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve     stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a     form of hypoventilation syndrome, for which this device is FDA approved. We will also     determine if the patient's quality and duration of life is improved by using the PNS to treat     CSA in heart failure patients.   "
3591|NCT03238924|"     Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may     develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a     cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating     its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a     promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong     biological and theoretical rationale for investigating the potential effectiveness of     augmenting PE with intranasal oxytocin, no studies to date have done so. The current study     aims to address this important gap in the literature by examining changes in PTSD symptoms     following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.   "
3592|NCT03238911|"     Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency     anaemia and comparison of the incidence of hypophosphatemia.   "
3593|NCT03238898|"     Objective: previous studies suggest that botulinum toxin A (BoNT/A) can reduce muscle     hyperactivity.      Research Design and Methods: a single-center, double-blind and placebo-controlled study     investigating the efficacy and safety of BoNT/A intramuscular injection for treating calf or     foot cramps refractory to common pharmacological drugs in patients with diabetic peripheral     neuropathy. Fifty patients were subdivided in two matched groups (cases and controls) and     BoNT/A (100 or 30 units) was injected for each side into the gastrocnemious or the small     flexor foot muscles, respectively, according to the predominance of leg or foot cramps.     Responders were evaluated again with a second BoNT/A administration.      The changes of pain intensity (primary outcome) and the changes in cramp frequency, the and     the Cramp Severity Scale (CSS) were evaluated over the course of 20 weeks after BoNT/A     administration.   "
3594|NCT03238885|"     This study plans to construct a MR radiomics model for predicting pathological complete     response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC)     patients.   "
3606|NCT03238729|"     This study assesses the ability of ambulatory patients with heart failure (HF) to use a     smartphone application created for the management of patients with chronic HF. This study     will aim:        -  To understand the frequency with which ambulatory HF patients engage with this          smartphone application.        -  To determine whether patient's knowledge of HF and its management has improved with the          use of this smartphone application.        -  To assess improvement in quality of life measures related to the use of this smartphone          application.        -  To assess improvement in lifestyle measures related to the use of this smartphone          application.   "
13395|NCT03110094|"     Interventional study with minimal risks and constraints, prospective, mono-centric.   "
3595|NCT03238872|"     Anxiety and depression are among the most common mental disorders in the population. Anxiety     and depression have significant consequences at the individual, family and community level,     and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner     annually. The majority of this amount is accounted for by anxiety and depression disorders.     Meanwhile, access to mental health services to treat these disorders is limited. The     proportion of people who do not receive treatment of those who are in need of treatment is     estimated to be over 50%.      Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of     Health commissioned by the Ministry of Health, with the goal of increasing access to     evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of     depression. The treatment offered is cognitive behavioural therapy and should lead to reduced     levels of symptoms of anxiety and depression, improved quality of life and better     employability. PMHC is based on the English program Improving Access to Psychological     Therapy (IAPT), which is established in virtually all health communities in England.      The evaluations of IAPT and PMHC have until now been based on relatively weak research     designs which make it difficult to know to what extent the initiative really has the desired     effect. In this study, PMHC is compared with a control group that receives treatment as usual     (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and     Sandnes). Participants are randomly assigned to either the PMHC or the control group. The     investigators aim to include 1100 clients in the study.      The key objectives of this study are to investigate whether PMHC treatment is more effective     as compared to treatment in the control group with regard to symptoms of anxiety and     depression, work participation, functional status, and mental well-being. Cost-effectiveness     of PMHC is also examined.   "
3596|NCT03238859|"     The goal of this double-blind sham controlled study is to evaluate the effeicacy of     continuous theta burst stimulation to the frontal pole as a tool to decrease drug cue     reactivity and improve treatment outcomes in treatment-engaged cocaine and alcohol users. All     participants will be randomized to receive 10 days of real or sham rTMS to the frontal pole.     Brain imaging data and behavioral assessments will be collected at 4 time points - before     TMS, after 10 days of TMS, 1 month follow up and 2 month follow up.   "
3597|NCT03238846|"     This study aims to evaluate the effectiveness of two strategies for multi-month dispensing     (MMD) of ART in Community ART Refill Groups (CARGs) on retention, virologic suppression, and     cost compared to standard of care.      This study is a three-arm cluster-randomized controlled trial conducted among 5,760 stable     HIV-positive patients) in Zimbabwe to compare outcomes of three antiretroviral therapy (ART)     dispensing models. Outcomes of retention in care, virologic suppression, and cost     effectiveness will be investigated in 30 purposively selected clusters (facilities) which are     randomized into three arms; standard of care (3 months dispensing at facilities), three-month     dispensing in CARGs, and six-month dispensing in CARGs. Each study arm will have 10 clusters     stratified into 2 urban and 8 rural. Study participants will be followed, and outcomes will     be measured at 12 months and 24 months. Qualitative research will be conducted at baseline,     12 months, and 24 months (20 participant Focus Group Discussion (FGDs) and 20 provider Key     Informant Interview (KII) at each interval) to understand patient and health provider     acceptability of multi-month dispensing of ART within CARGs. Other outcomes of interest     include measuring gains of facility decongestion and feasibility of multi-month dispensing of     ART within CARGs. Cost analysis will include comparisons of patient level costs, cost per     patient outcomes and cost effectiveness across the three study arms.   "
3598|NCT03238833|"     The investigators attempted to compare the clinical outcomes and cumulus genes expression in     poor ovarian responders undergoing luteal ovarian stimulation or follicular ovarian     stimulation in in vitro fertilization cycles.   "
3599|NCT03238820|"     Patients with gastric gastrointestinal stromal tumors will receive robotic resection.   "
3600|NCT03238807|"     Subfertility is the inability to conceive after 12 months of regular unprotected sexual     intercourse. Around 15% of couples suffer from subfertility. As a treatment for subfertility,     Assisted Reproductive Techniques (ART) have been a choice for subfertile couples. In Egypt in     2010, Pregnancy Rate was calculated to be 36.2%, Live Birth Rate to be 25.7%.      Implantation is the process by which the embryo adheres to the wall of the uterus.     Endometrial receptivity plays the most important role for successful implantation after     embryo quality. It is estimated that up to 70% of early pregnancy losses are due to failure     of implantation.      Despite extensive research, the embryo-maternal dialogue that orchestrates the implantation     process is still not fully understood. Much effort has been done in the last decades to     detect factors affecting Implantation and improve endometrial receptivity.      Human Chorionic Gonadotropin (hCG) is a placental glycoprotein hormone that required to     maintain pregnancy. Recent research data demonstrates that hCG is secreted very early by the     embryo before implantation to facilitate it. hCG has been proved to cause attraction of     inflammatory cells, promote angiogenesis, regulate chemical mediators at the endometrium.     These effects proceed the classical role of hCG during pregnancy and could be a directly     involved in and facilitating the implantation process.      Studies have been conducted to study the effect of injection of different concentrations of     hCG inside the uterine cavity before Embryo Transfer (ET) to improve endometrial receptivity     and outcomes of In-Vitro Fertilization (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI)     cycles.      A recent systematic review was conducted on 12 studies performing intrauterine injection of     different doses of hCG before ET. Results of this study showed that there is increased     pregnancy outcome after injection of intrauterine 500 IU of hCG. The study recommended a     definitive large clinical trial with live birth as the primary outcome. There was no evidence     that miscarriage was influenced by intrauterine hCG administration, irrespective of embryo     stage at transfer or dose of intrauterine hCG.      Aim of the study:      To detect whether intrauterine injection of hCG before ET improves clinical outcomes in     IVF/ICSI cycles.   "
3601|NCT03238794|"     It is unknown whether the bile acid pathway reacts differently to weight loss resulting from     Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction     alone.   "
3602|NCT03238781|"     To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period     in monthly migraine days in subjects with migraine.   "
3603|NCT03238768|"     The overall objective of the proposal is to demonstrate the feasibility of providing     increased calories and protein in the first week of life to very low birth weight (VLBW)     preterm infants.   "
3604|NCT03238755|"     In this study, investigators plan to test whether statins can preserve and/or improve     diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy.     Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic     dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo     cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial     steatosis prior to initiation of statin or placebo therapy and then two years after     initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk,     systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and     markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS     outcomes.   "
3605|NCT03238742|"     The Efficacy of Xuebijing Injection in Adult Patients with Sepsis   "
3607|NCT03238716|"     The purpose of this research is to compare two different approaches for treating patients     with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and     electric dry needling versus electric dry needling. Physical therapists commonly use all of     these techniques to treat stress urinary incontinence. This study is attempting to find out     if one treatment strategy is more effective than the other.   "
3610|NCT03238677|"     The study will test two modifications to speech therapy for 40 school-age children with     childhood apraxia of speech to determine how to improve treatment outcomes. The study will     compare treatment that includes real-time visual feedback of the tongue during speech using     ultrasound vs traditional therapy that does not include ultrasound visual feedback.     Additionally, some children will be treated with a traditional schedule of 2 sessions per     week, whereas others will be provided with treatment that begins with intensive training (10     hours of therapy in one week) and progresses to a more distributed treatment schedule.   "
3611|NCT03238664|"     This randomized pilot trial studies how well robot-assisted laparoscopic high-intensity     focused ultrasound works compared to robot-assisted radical cystectomy for thermal ablation     of muscle invasive cells in patients with bladder tumors. Laparoscopic high-intensity focused     ultrasound uses high frequency sound waves to deliver a strong beam to a specific part of the     tumor and may lower the number of tumor cells released into the blood stream compared to     radical cystectomy.   "
3612|NCT03238651|"     The purpose of this study is to determine the safety, tolerability, maximum tolerated dose     (MTD) and/or recommended phase 2 dose (RP2D) of TAK-659 when administered in East Asian     participants with NHL who do not have an effective standard treatment available and to     characterize the plasma and urine pharmacokinetic (PK) of TAK-659 in East Asian participants     with NHL.   "
3613|NCT03238638|"     This is a research study to test the combination of two drugs, pembrolizumab and epacadostat     with the goal of benefiting subjects with head and neck cancers where prior or ongoing     regimens with a PD-1 or PD-L1 inhibitor for the treatment of advanced head and neck cancer     after platinum failure.   "
3614|NCT03238625|"     This study examines whether the injection of local anesthesia mixed with sodium bicarbonate     in the ratio of 3:1 creates a less burning sensation and is as effective regarding the     anesthetic effect as in the ratio of 9:1.   "
3615|NCT03238612|"     It is well recognized that respiratory viruses cause substantial disease burden every year.     Among all known respiratory viruses, influenza virus is the greatest cause of     disability-adjusted life years lost, excess hospitalizations, and deaths in the elderly and     patients with chronic illness. These patients are frequently hospitalized for pneumonia     secondary to these respiratory viral infection. Recently, macrolide antimicrobial     clarithromycin and flufenamic acid (FFA) have been shown to inhibit seasonal influenza virus     infection in human airway epithelial cells with additional anti-inflammatory effect.      The investigators therefore plan to conduct a 3-year prospective study among adult patients     hospitalized in Queen Mary Hospital for influenza with secondary pneumonia and randomized     them to receive a course of oseltamivir + FFA + clarithromycin (as treatment) vs. a course of     oseltamivir (current standard treatment as control). The objective of this prospective     double-blind randomized controlled trial is to evaluate the efficacy of clarithromycin and     FFA antiviral therapy in patients diagnosed to have pneumonia secondary to influenza     infection.   "
3616|NCT03238599|"     The trial assess the proportion of patients who resumed their professional activity within     100 days after ASCT (autologous stem cell Transplantation).   "
3617|NCT03238586|"     A clinical study for patients with HIV that investigates the best way to reduce HIV     transmission risk, and to improve the overall health of people living with HIV/AIDS.     Participants will complete four assessments over the course of one year and will be randomly     assigned to a five-week treatment program.   "
3618|NCT03238573|"     When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist     gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp     will be resected for the biopsy.   "
3619|NCT03238560|"     The investigators' aim was to evaluate the population pharmacokinetics of montelukast in     infants and children and define the appropriate dose in order to optimize Montelukast     treatment in this vulnerable population.   "
3620|NCT03238547|"     Microalbuminuria is an important biomarker for the development of diabetic nephropathy and     cardiovascular complications. Since microalbuminuria is not easily detected on routine     urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio     (uACR) annually in a patient with diabetes mellitus. While the standard method is     quantitative measurement using turbidimetric immunoassay, it requires high cost and special     laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in     many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and     inexpensive, could be used as a substitute to the current standard quantitative measurement.     The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine     albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in     patients with diabetes.   "
3621|NCT03238534|"     Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or     epigastric pain   "
3622|NCT03238521|"     To compare classical pedicle finder versus pedicle finder with impedancemetry on the     perioperative radiation exposure of PPTLO. These two devices are already used in common     practice.   "
3623|NCT03238508|"     This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA)     in patients who underwent immediate versus deferred stenting during percutaneous coronary     intervention (PCI) for acute myocardial infarction.   "
3624|NCT03238495|"     The primary objective of this study is to determine the efficacy of metformin as a repurposed     agent in human epidermal growth factor receptor 2 (HER2) positive breast cancer when added to     standard neo-adjuvant chemotherapy.   "
3625|NCT03238482|"     The purpose of this study is to compare absorption of salmeterol and fluticasone from     Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide     Diskus   "
3839|NCT03235635|"     This is single center study. The investigators will try to know that relationships between     intestinal microbiome and mortality in preterm infants and what relationships is between     intestinal microbiome in preterm infants and morbidity, mortality.   "
3626|NCT03238469|"     With microwave ablation (MWA), using the heat generated from electromagnetic waves in the     microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated     through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis     (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat     glands, the investigators hypothesize a beneficial and long-term sustainable preventive     effect of MWA in HS patients.   "
3628|NCT03238443|"     The study is a prospective observational mono center study      Primary objective :      Study the anti-HLA antibodies frequency preformed before liver transplantation and the     kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver     transplantation.      Secondary objective :        -  Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)        -  Impact of DSA on:             -  Graft and patients survivals             -  Onset of allograft rejection (acute, late-onset, chronic)             -  Unexplained liver graft dysfunction             -  Unexplained liver enzymes abnormalities             -  Liver fibrosis development (liver stiffness study using fibroscan©)   "
3629|NCT03238430|"     The study will compare the continuous infiltration of local anesthetics and rachianalgesia in     terms of decreased postoperative morphine consumption and incidences of chronic postoperative     pain at 3 and 6 months after hepatic surgery compared to the control group.   "
3630|NCT03238417|"     Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in     quality and patient experience among women seen in VA. VA policy action providing guidance on     delivery of comprehensive healthcare services for women Veterans was disseminated nationally     in 2010, followed by annual assessments and sites visits evaluating local VA efforts. While     substantial inroads have been made, policy implementation, even when leveraged by field-based     women's health leaders, has not been uniformly successful in achieving delivery of     comprehensive care by designated providers in gender-sensitive care environments that ensure     women's privacy, dignity and safety, all tenets of the original guidance and the updated VHA     Directive (2017).      In collaboration with VA Women's Health Services (WHS), VA researchers developed a series of     studies to better understand and help improve comprehensive care implementation through the     Women Veterans' Healthcare CREATE Initiative. Among these, one focused on testing an     evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model --     Patient Aligned Care Teams or PACT -- to the needs of women Veterans, which has yielded     significant local improvements in women Veterans' care. EBQI emphasizes a multilevel     partnered approach to building capacity for innovation, implementation and spread of     evidence-based practice. With its demonstrated success in the CREATE PACT study and several     other EBQI trials, WHS adopted EBQI as a strategy to help low-performing VA facilities     systematically improve services.      The objectives of the WHS/QUERI Partnered Evaluation Initiative that this project represents     are:        1. To evaluate the barriers and facilitators to achieving delivery of comprehensive women's          health care in the identified low-performing VA facilities;        2. To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve          improved:             1. Organizational features (e.g., level of comprehensive services available; care               coordination arrangements; PACT features implemented; environment of care               improvements);             2. Provider/staff attitudes (e.g., improved gender awareness; women's health knowledge               and practice);           d) Quality of care and patient experiences among women Veteran patients using secondary          data; and,        3. To evaluate contextual factors, local implementation processes, and organizational          changes in the participating facilities over time.      Results of the evaluation will be used to provide feedback to stakeholders, including women     Veterans, at the local, network and national levels, while also being used to continuously     refine EBQI implementation processes. The evaluation will also help inform optimal strategies     for ongoing improvements in women Veterans' care in the 24 participating VA facilities, other     VA facilities and for other improvement initiatives in this and other program offices.   "
3631|NCT03238404|"     Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced     recovery after surgery (ERAS) programs.   "
3632|NCT03238391|"     The purpose of this study is to demonstrate the effectiveness of ischemic preconditioning in     the emergency department to prevent contrast induced nephropathy   "
3633|NCT03238378|"     The aim of the present trial is to assess the prospective results of protocol-based     interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a     group of selected patients where salvage surgery with clear resection margins was not     possible.   "
3634|NCT03238365|"     This randomized pilot early phase I trial studies how well nivolumab with or without     tadalafil work in treating patients with head and neck squamous cell carcinoma that has come     back and can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere     with the ability of tumor cells to grow and spread. Tadalafil may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and tadalafil     may work better in treating patients head and neck squamous cell carcinoma.   "
3635|NCT03238339|"     The subjects of this study are the chronic obstructive pulmonary disease (COPD) patients with     chronic II respiratory failure. The participants will be divided into two groups: The     Portable Home Noninvasive Ventilator treatment group and the routine home oxygen inhalation     treatment group. All subjects will be given a stable COPD regimen and conventional oxygen     therapy ,but the portable home noninvasive ventilator treatment group will need to wear a     portable non-invasive ventilator. Objective evaluation indexes were established during the     routine treatment, and two groups of subjects will be followed up for one year. Finally, the     clinical data of all subjects will be analyzed，and then the practicability of portable     wearable household noninvasive ventilator will be verified.The researchers will also build a     remote breathing data-monitoring platform based on mobile internet,and a community home     demonstration application point.   "
3637|NCT03238313|"     The purpose of the study is to determine if exposure to the Plan A video causes decreased     risky sexual behavior among the target population.   "
3638|NCT03238300|"     This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant     supplement on brains of youth (ages 15-19) using magnetic resonance imaging (MRI). 50     adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice     daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days.     Urine and blood samples will be collected at baseline and urine samples again before and     after each course of medication treatment. Participants will receive a 1- hour MRI scan at     baseline and after each treatment trial.   "
3757|NCT03236727|"     Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in     latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine,     a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also     the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not     been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during     posterior spinal fusion surgery before and after Dexmedetomidine administration.   "
3650|NCT03238144|"     This project is investigating a novel MRI method called Magnetic Resonance Force (MRF). MRF     has been developed to accurately estimate tumour stiffness in the breast by measuring the     interstitial fluid pressure (IFP).      50 healthy volunteers will be recruited to extend the hardware and establish MRF imaging     acquisition protocols for pre and post-menopausal women. Once completed, we will test this     new imaging technique with the acquired imaging protocols on 100 patients undergoing surgery     as first line of their treatment for their breast cancer to establish a potential biomarker     signature predictive of lymph node involvement and metastatic potential. Simultaneously, 50     patients undergoing chemotherapy as first line of their treatment for their breast cancers     will be recruited to develop a biomarker signature that could predict response or resistance     to neoadjuvant chemotherapy as determined by conventional imaging and histopathology.   "
3639|NCT03238287|"     Post-resuscitation neurological impairment is associated with morbidity and especially with     late mortality. Thus, because good neurological outcome is vital for a successful     resuscitation, it is essential to have sufficient cerebral tissue perfusion and oxygenation     during its application. Near-Infrared Spectroscopy (NIRS) is used to evaluate such     conditions. NIRS is a non-invasive technique which provides real-time, continuous information     about regional cerebral tissue oxygen saturation levels (regional SO2/rSO2). Research on NIRS     has been done in many studies including cardiovascular surgery, neurosurgery and their     intensive care processes and its effectiveness has been approved. However, there is limited     data on its use in cardiac arrests.      As stated in the current guidelines, sufficient speed and depth of chest compressions, few     interruptions of compressions are key to a successful outcome of resuscitation. The studies     with the mechanical chest compression devices showed that the earlier it was applied in     out-of-hospital cases, the higher the rates of survival until hospitalization. There is not     sufficient number of studies on the routine use of mechanical chest compression devices for     in-hospital cases. In case the application of manual resuscitation is not convenient (during     patient relocation, procedure at the angiography laboratory, and rush hours of emergency     services when staff might fall short), alternative methods will be required.      The aim of our study is to compare rSO2 levels measured during resuscitation with manual and     mechanical devices in in-hospital (at the emergency department) witnessed cardiac arrest     cases and to analyze the impact of both application method and perfusion levels on survival     and neurological outcome.   "
3640|NCT03238274|"     The objective of this study is to demonstrate the clinical performance of the Sofia® 2     analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to     Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick,     whole blood and serum from symptomatic subjects.   "
3641|NCT03238261|"     Compare the use of radiotherapy and concomitant chemotherapy, with the single use of     radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an     outcome the three year survival rate, the disease free survival rate, the locoregional     control of the disease and the security of the treatments provided.      Specific objectives        1. Describe and compare the demographic and clinical characteristics of both groups.        2. Compare the three year survival rate in both groups.        3. Compare the response to treatment in terms of locoregional control of the disease.        4. Compare the appearance of severe and non severe adverse events directly related to the          treatment in both intervention groups.   "
3642|NCT03238248|"     This study will evaluate the treatment combination of pevonedistat and azacitidine in the     setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory     myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.   "
3643|NCT03238235|"     This is a phase 2, randomised, double-blind, placebo controlled study to evaluate the     micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy of     givinostat in patients with Becker Muscular Dystrophy. Approximately 48 eligible patients     will be randomized in a 2:1 ratio to be treated with givinostat or placebo for a period of 12     months.   "
3644|NCT03238222|"     Peripheral arterial disease can cause leg pain or discomfort (called intermittent     claudication (IC)), which limits the ability to walk and carry out everyday activities.     Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge     to begin and then continue. The aim of this study is to investigate if a physiotherapist-led,     behaviour change treatment effects walking in people with IC. The treatment is designed to     build an understanding of IC and walking exercise and help individuals develop strategies to     increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC.     All participants will visit King's College London or their local hospital to complete two     short walking tests and answer questionnaires about their daily activities, beliefs about     their symptoms and treatment, quality of life and the costs of having IC.      Participants will then be randomly assigned to receive either the new treatment or continue     with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at     the participant's home or local hospital) and two 20-minute telephone calls with a     physiotherapist who will discuss participants' understanding and beliefs about IC, walking     and help participants to set goals and plans to increase walking over 12 weeks. Participants     will be provided with a step counter (pedometer) and walking record.      After 12 weeks, all participants will attend a second appointment where they will repeat the     walking tests and fill out another set of questionnaires. A final set of questionnaires will     be completed by all participants after 6 months (by post or electronically). Some     participants will be invited to provide feedback on their experience of the treatment and     trial by telephone or a face-to-face interview with a researcher.   "
3645|NCT03238209|"     To evaluate the compatibility and correlation between noninvasive surface respiratory     electromyography and invasive transesophageal diaphragmatic electromyography measurements, as     facilitating indicators of neural respiratory drive evaluation during treadmill exercise.     Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface     diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and     surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing     capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was     quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and     RMSsc.   "
3646|NCT03238196|"     This is an open-label, multi-institution, phase Ib trial that evaluates the safety and     tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib     in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.   "
3647|NCT03238183|"     Using double blind, randomized controlled design to study the immediate, short-term and     intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and     hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.   "
3648|NCT03238170|"     To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as     part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy     planning systems, so that it can be potentially used to reduce healthy tissue exposure to     radiation. Subsequently, the protocols and procedures established can be used to put the     technique into routine clinical practice.   "
3651|NCT03238131|"     Onchocerciasis is a vector-borne nematode parasitic disease that causes severe disability.     Onchocerciasis affects approximately 33 million people, mostly in 30 countries in sub-Saharan     Africa (with small foci in Latin America and Yemen) 1This disease causes blindness and severe     skin disease and it is spread by black flies. O. volvulus adult worms live in subcutaneous     nodules. O. volvulus adult worms are larger and less sensitive to available drug treatments     than those of the species that cause Lymphatic Filariasis (LF). They also have a longer     lifespan (approximately 14 years rather than the estimated 7 years for LF parasites). Several     programs and developments have greatly improved the Onchocerciasis. situation since the     1970's when the Onchocerciasis Control Programme (OCP) in West Africa (green countries in the     map) was initiated. OCP relied exclusively on vector (black fly) control in its early years.     However, following the appearance of Ivermectin (Mectizan) on the scene in the late 1980's,     OCP transitioned to become a drug distribution program with annual IVM MDA in 11 countries.     OCP ended in 2002. This was replaced by the African Program for Onchocerciasis Control (APOC)     which coordinates community directed distribution of IVM MDA in 28 African countries     (including the former OCP countries). OCP and APOC have done a good job of reducing parasite     infection intensities and Onchocerciasis disease rates in many endemic countries.     Unfortunately, there is no real end in sight for the APOC approach (apart from a funding     endpoint in 2015); while it may be possible to eliminate Onchocerciasis. In selected areas by     MDA with IVM (alone, or combined with vector control), disease control programs in most     African countries will require active maintenance for many years to come. While IVR has good     activity against the parasite larvae that cause disease in the skin and eye (microfilariae or     Mf), it does not kill O. volvulus adult worms, and they resume production of Mf that can lead     to transmission of new Onchocerciasis. Cases by black flies after a few months. APOC     activities are focused on areas with high infection rates (where disease risks are highest).     However, extensive areas in Africa where fewer than 20% of adult men have Onchocerciasis     nodules detectable by palpation are not receiving interventions for Onchocerciasis at this     time. These areas are not disease free. (Onchocerciasis dermatitis can be severe in     hypoendemic areas), and they also may serve as a source for reintroduction of the parasite     into previously controlled areas after interventions stop.   "
3652|NCT03238118|"     The aim of this project is to evaluate the efficacy of an attention bias modification     training if compared to an attention control and psychoeducation to reduce the symptoms of     irritability among children with high levels of irritability.   "
3653|NCT03238105|"     Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as dark     circles, is a relatively common condition and a frequent reason for dermatological     consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which     mainly involves the lower eyelids. POH affects individuals over a wide age range, including     both sexes and all ethnicities, and is associated with a tired and aged facial appearance.     The most commonly affected people are those with the highest skin phototypes. Although the     prevalence is similar between sexes and age groups, POH is a more frequent complaint in     women. The dark circles characteristic of POH can negatively impact patients' quality of     life, although it is not a condition associated with morbidity. Despite its high prevalence,     only a few well-designed studies were done to evaluate its therapeutic options. The intense     pulsed light (IPL) and the thioglycolic acid are safe treatment options and promote the     improvement of dark circles, but it is not known if one treatment differs from the other in     relation to efficacy and adverse effects.   "
3654|NCT03238092|"     In vitro fertilization(IVF) with Gonadotropin-releasing hormone (GnRH) antagonist is one of     the most used protocol for the treatment of infertile couples nowadays. Despite several     advantages over GnRH agonist, the antagonist may be associated with a slightly reduction in     pregnancy rates.      Several medications have been tested in order to increase ovarian response to ovulation     induction, including estradiol and testosterone. A clinical trial in women with IVF     indication will be performed and this women will be randomly assigned to receive topic     testosterone, oral estradiol or no pre-treatment prior to IVF with human Chorionic     Gonadotropin (hMG) and GnRH antagonist. The primary endpoint will be the size and number of     follicles on the beginning of the cycle, after pre-treatment.   "
3655|NCT03238079|"     The purpose of this study is to investigate the efficacy, safety, tolerability, and     pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on     the basis of historical control data, how it compares with other 10% intravenous     immunoglobulin (IGIV) products currently licensed in North America for the treatment of     subjects with primary immune deficiency diseases (PIDD).   "
3656|NCT03238066|"     Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent     prostate carcinoma following external beam radiation therapy.   "
3657|NCT03238053|"     Women with genitourinary syndrome of menopause, with breast or endometrial cancer are     randomized to either laser treatment og sham treatment for 3 months. The randomization is     stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and     microbiology swaps   "
3658|NCT03238040|"     This study is a large multi-centre collaboration between a busy regional paediatric intensive     care transport service (Children's Acute Transport Service, CATS), four large paediatric     intensive care units (PICUs at Great Ormond Street Hospital, St Mary's Hospital and Royal     London Hospital in London, and Addenbrookes Hospital in Cambridge) and the Department of     Paediatrics at Imperial College, London. CATS transports over 800 sick children on life     support to the three PICUs each year.      We aim to improve our understanding of the genetic basis and biological pathways by which     children with acute infection or injury become critically ill and develop failure of vital     organs, and how these factors influence outcome. We will establish well-characterised cohorts     of sick children with diverse pathologies, in whom blood, urine and other samples will be     collected at an early stage of critical illness. Samples will be analysed using genomic,     transcriptomic, proteomic and metabolomic approaches. Advanced bioinformatics techniques will     be used to identify biomarkers for early diagnosis and robust risk stratification. We will     focus on biomarkers to help distinguish between serious bacterial infections, viral     infections and other causes of critical illness; diagnose incipient organ failure; and     accurately identify, early on, children at high risk of developing a poor outcome.      We will recruit critically ill children at first contact with the CATS team, during emergency     transport to PICU. Due to the emergency nature of the research, and minimal risk associated     with the study procedure, we will seek deferred, written informed consent from     parents/guardians once their child has been stabilised, within 24-48 hours following PICU     admission.      By studying these important questions, we aim to better understand how we can diagnose and     provide early life-saving treatments to critically ill children. The research team have an     established track record of successful completion of several large clinical studies in     critical care as well as validation of biomarkers in other diseases.   "
3660|NCT03238014|"     High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the     gas exchange and reduce the work of breathing of patients, is a new strategy targeted at     maximally reducing arterial carbon dioxide. However, no definitive conclusions have been     drawn to decide whether high-intensity NPPV is the best setting for treating patients with     chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has     been established. Most of the trials utilized gradually increased inspiratory positive airway     pressure depending on the patient's tolerance. However, from a respiratory physiology point     of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation,     increased intrinsic positive end expiratory pressures, increased oxygen consumption, and     ineffective work of breathing.Therefore, seeking a method to establish individualized     high-intensity NPPV is of vital importance.   "
3661|NCT03237988|"     This will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety,     and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on     single oral doses of CPI-444 tablets in healthy male and female subjects. Potential subjects     will be screened to assess their eligibility to enter the study within 28 days prior to the     first dose administration.   "
3662|NCT03237975|"     1. Objectives of the Project           The BEYO project is designed based on the middle range theory of self-care of chronic          illness and salutogenic theory. The aim of this project is to facilitate self-care          behaviours of community-dwelling elderly patients with type 2 diabetes through promoting          SOC, and accordingly improve their health outcomes, including promoting quality of life          and reducing diabetes-related emotional distress.        2. Content of the Project      BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant     and 8 elderly patients. 5 weekly sessions are provided to let patients receive health     knowledge, discuss problems and experiences, explore available resources and build up goals     and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network     among group members and introduce group goals and tasks. Session 2-4 covers six topics based     on the Chinese guideline for type 2 diabetes released by Chinese diabetes society: (i)     healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose     monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress.     These middle sessions execute a common session flow to construct an action plan utilizing     patients' resources and strengths to achieve the client-centered goal. Session 5 aims to     review the process, summarize effective solutions, and set up plans for the future. One-week,     one-month and three-month telephone follow-ups are delivered to help patients solve problems     encountered during implementing the action plan and evaluate their self-care, SOC and other     health outcomes.   "
3663|NCT03237962|"     The primary purpose of this study is to compare and assess the immediate and long-term     effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen     therapy device.      The hypotheses was, with high flow nasal cannula usage while exercising, the physiological     outcome measurements would be better than conventional oxygen therapy device. Also, the usage     of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused     by exercising.   "
3664|NCT03237949|"     This is an extension of a previous feasibility study (Clinical Trials Registry -     NCT02571244). The actual study is a research aimed to compare the effectiveness of telephone     counseling and personalized text messages (TM) for supporting post-discharge quit attempts     among hospitalized smokers, with focus on smoking cessation as the main outcome. Smokers     patients will receive brief interventions and nicotine replacement therapy during the     hospitalization. After discharge smoker patients will be allocated into a intervention or     control arm. In the first and third months, after randomization, the patients will be contact     to smoke abstinence assessment.   "
3665|NCT03237936|"     The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of     concept study. The study is designed to assess the effect on the quality of vision of     IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED)     patients with severe keratitis, as well as its safety and efficacy.   "
3666|NCT03237923|"     The EasySense device is a non-invasive device designed to measure lung fluid in patients with     Congestive Heart Failure (CHF). This study seeks to evaluate the efficacy of the EasySense     system in measuring lung fluid volume.   "
3667|NCT03237910|"     AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest     patients.      The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR     may predict the success of defibrillation and optimize the timing of defibrillation delivery.      The primary end-point is the efficacy of the AMSA-CPR: termination of VF/VT with achievement     of ROSC for an AMSA ≥ 15.5 mV-Hz      All patients meeting inclusion/exclusion criteria and receiving cardiopulmonary resuscitation     are randomized into two groups: AMSA-guided CPR or standard CPR.      In the AMSA-CPR group, AMSA value suggests when the rescuer should deliver the defibrillation     attempt; In the Standard-CPR group, the defibrillation is delivered based on the 2015     European Resuscitation Council (ERC) CPR guidelines.   "
3668|NCT03237897|"     The purpose of the study is to evaluate the value and effectiveness of a newly-implemented     preoperative education class for patients undergoing colorectal surgery.   "
3669|NCT03237884|"     Palliative Care procedures should be integrated early in the course of disease of patients     with advanced incurable cancer. With this study, where the investigators follow adult     patients with incurable cancer over 6 months or until death (whatever occurs earlier), the     investigators aim to identify patients' needs for Palliative Care interventions (like support     in illness understanding and decision making, symptom management, concrete end-of-life     preparation, and others) and their remembered delivery by health care professionals. The     investigators also collect data on patients care (use of chemotherapy, intensive care in the     last month of life) and quality of death and dying (assessed by post-death-interviews with     bereaved relatives). The aim is to have a reality map on current integration of oncology     and palliative care and to test if appropriate Palliative Care interventions predict a better     outcome.   "
3758|NCT03236714|"     Preoperative fasting is mandatory for anesthetic induction. This period of fasting is     probably greater due to delays in the surgical theater and changes in daily operation     schedules.Investigators want to resarch between the prescribed and the actual preoperative     fasting time.   "
3691|NCT03237598|"     With the development of economics in China, the dietary diversity got higher. Meanwhile, the     prevalence of metabolic syndrome (MetS) raised up as well. To investigate the gender     difference of getting MetS and its various associations with dietary diversity at different     ages.Data of adults(n=4308) aged 18+ y with three consecutive 24-h recalls and complete     co-variates information were extracted from Chinese Nutrition and Health Survey in 2009.     Modified Dietary Diversity Score (DDS) was adopted to capture the diversity of diet. MetS was     defined by the harmonized criteria. Multivariable adjusted logistic regression was carried     out to detect the association between DDS and MetS and its components for young, middle aged     and elderly adults by a cross-sectional study.      More detailed information can be found in Pubmed,PMID: 24341753 (The China Health and     Nutrition Survey, 1989-2011.).   "
3670|NCT03237871|"     As part of the development of the Engaging Microenterprise for Resource Generation and Health     Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the     feasibility of assessing economic and sexual risk behaviors using text messages. The team     will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless,     out-of-school, and un/under-employed. Participants will complete a text-messaged survey each     week for 5 weeks. The study team will collect information about the number of participants     who respond to the weekly survey, the number of questions to which they respond in each     survey, and the number of hours from sending a survey to participants to receiving their     response. As an exploratory aim, participants will also receive 3 informational text messages     each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain     qualitative feedback from participants regarding text messages they most and least liked. The     survey is not designed to evaluate the effectiveness of the text message intervention.   "
3671|NCT03237858|"     The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial     intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic     feature.   "
3672|NCT03237845|"     The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo     in subjects with Acute Migraines   "
3673|NCT03237832|"     This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy     subjects.   "
3674|NCT03237819|"     Thrombotic Thrombocytopenic Purpura (TTP) is a potentially life-threatening thrombotic     microangiopathy caused by a severe deficiency of ADAMTS13 (a disintegrin and     metalloproteinase with a thrombospondin type 1 motif member 13). Decreased ADAMTS13 activity     leads to an accumulation of ultralarge von Willebrand factor (vWF) multimers which induce     aggregation of platelets and microthrombi. These microthrombi may involve the brain, heart,     kidneys and lead to life-threatening organ failures.      In experimental models, magnesium sulfate increases cleavage of newly released vWF by     ADAMTS13, decreases the endothelial secretion of ultralarge vWF and inhibits the interaction     of vWF with platelets. In another thrombotic microangiopathy, magnesium sulfate has been     shown to reduce the risk of seizures in women with severe pre-eclampsia. In analogy with its     evidence-based therapeutic application in pre-eclampsia and based on a strong rationale for     magnesium supplementation in TTP, we propose a phase 3, double blind, placebo controlled, and     randomized study to evaluate the efficacy of magnesium sulfate in more rapidly restoring     normal platelet counts as measure of prevention of further microvascular thrombosis in     patients with Thrombotic Thrombocytopenic Purpura.   "
3675|NCT03237806|"     The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory     failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS     patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near     diaphram during mechanical ventilation, however, strong respiratory drive could generate more     transpulmonary pressure in ARDS patients, which increase the stress and strain in injured     lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of     ARDS patients.The purpose of this study is to investigate the effects of sedation on     transpulmonary pressure of ARDS patients.   "
3676|NCT03237793|"     The present study was designed as a randomised controlled clinical trial which was unicenter,     double-blinded, parallel designed study, according to the Consolidated Standards of Reporting     Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.   "
3677|NCT03237780|"     This randomized phase II trial studies the side effects of atezolizumab with or without     eribulin mesylate and how well they work in treating patients with urothelial cancer that has     come back, spread to nearby tissues and lymph nodes, or other places in the body. Monoclonal     antibodies, such as atezolizumab, may block tumor growth in different ways by targeting     certain cells. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving atezolizumab and eribulin mesylate may     work better at treating urothelial cancer.   "
3678|NCT03237767|"     A great medical success is the increase in the median survival age associated with cystic     fibrosis (CF). However, this success has led to a new era of research aiming to maximise the     quality of life (QoL) of the aging CF population. Over recent decades, exercise training has     become an integral part of CF management by improving ones aerobic exercise function and QoL.     However, the effects exercise training has upon other aspects of the disease, e.g. metabolic     and vascular abnormalities, remains largely unknown.      The increased survival age associated with CF means the non-pulmonary co-morbidities are     becoming increasingly prevalent and clinically important. For example, CF-related diabetes     (CFRD) is one of the most common non-pulmonary co-morbidities of CF, and is associated with     patients having a poorer pulmonary function and nutritional state, which ultimately leads to     a worsened prognosis. Despite the efficacy of exercise training to manage dysglycaemia in     other populations (e.g. type 2 diabetes mellitus only a single study has investigated its     efficacy in patients with CF, whereby authors reported various encouraging findings (e.g. an     improved OGTT score and insulin sensitivity).      The present study aims to build on previous trials by comparing the therapeutic effects of a     single session of high-intensity interval exercise (HIIE) and moderate intensity exercise     (MIE) upon the 24 hour, ambulatory glycaemic profile of patients with CF. Additionally, the     present study will identify whether HIIE and/or MIE can mediate the consequences of transient     hyperglycaemia when considering: biomarkers of inflammation, oxidative stress and nitric     oxide (NO2) bioavailability, as well as functional measures of microvascular endothelial     function.      The present study supports the top 10 research priorities set by the CF Trust, by further     investigating the potential for exercise training to prevent/manage multiple aspects of CF,     including dysglycaemia.   "
3689|NCT03237624|"     The aim of this prospective randomized 3-month double-blinded single center study is to     determine whether a chewing gum device with food additive chitosan, will aid in reducing     gingival inflammation by supplementing traditional tooth brushing and flossing measures.     Patients with mild to moderate gingivitis will be identified and enrolled in this     investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions     and a baseline clinical examination of the gingiva. The test group will utilize the test     chewing gum three times a day for a minimum 20-30 minutes duration; the control group will     receive a placebo gum and use it in a similar manner. We will examine whether daily use of a     functional chewing gum enhances improvements to brushing and flossing.   "
3690|NCT03237611|"     Low dose aprepitant for patients receiving carboplatin.   "
3759|NCT03236701|"     To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish     included in two meals a week with an amount of egg white containing the same quantity of     proteins.   "
3679|NCT03237754|"     Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic)     drug therapy. In contrast, neurophysiologically guided treatments might provide an     alternative avenue, since these can normalize brain alterations without side effects.     Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic     treatment of migraine, probably because of its modifying and re-balancing influence on     neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it     is necessary to apply not only tDCS but also a sham placebo, which is often neglected in     tDCS stimulation studies. Further, tDCS needs to be applied in a large (n > 20) sample of     well-defined migraine patients, which would be advantageous, compared to previously published     work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS     is essential to investigate physiological mechanisms of tDCS. There is an increasing interest     towards non-pharmacological treatment alternatives for migraine (and headache disorders) with     reduced side effects to established prophylactic medications. The primary outcome of this     project is to demonstrate that repetitive sessions of neurostimulation lead to a significant     and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients     suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays     accepted as therapeutic tools, our study might provide evidence that tDCS can be a     non-pharmacological alternative for treating migraine.   "
3680|NCT03237741|"     This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female     volunteers of non-childbearing potential. The first part of the study will compare the     bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference     capsule (Periods 1 and 2). The second part of the study will assess the effect of     GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat     foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a     proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).   "
3681|NCT03237728|"     Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients   "
3682|NCT03237715|"     Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in     term and late preterm infants during the first week of life.      Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their     relationship to unbound fatty acid (FFAu) levels.      Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.   "
3683|NCT03237702|"     Through a better understanding of the biology of significant (lethal) prostate cancer, we     hope to develop new markers/targets from urine metabolomics for more effective screening and     prevention of significant prostate cancer. In the meantime, with these new markers we may     substantially reduce overtreatment of insignificant PC.   "
3684|NCT03237689|"     Despite treatment with antiretroviral therapy, women living with HIV continue to experience     cognitive impairment. Psychological risk factors, including stress, impair cognition more in     HIV-infected women than HIV-uninfected women. This study plans to examine a novel     intervention for cognitive dysfunction that targets the mechanisms by which stress negatively     affects cognitive functioning.   "
3685|NCT03237676|"     This research is a randomised controlled study. The study hypothesis is cognitive     rehabilitation for attention deficits following mild traumatic brain injury will improve     patient's cognitive outcome, measured by neuropsychological and neuroimaging parameters.     Participant recruitment is from University Malaya Medical Centre, Malaysia. All mild     traumatic brain injury participants have to fulfil the study inclusion criteria and written     consented for therapy. Control group receives existing patient-centred cognitive treatment     whereas intervention group receives individualised structured cognitive rehabilitation     therapy. The intervention begins at three months post injury and ends at six months post     injury. Study outcome measurements are applied at pre and post treatment. This study was     ethically approved by Medical Research Ethics Committee University Malaya Medical Centre     (MREC ID NO: 2016928-4293).   "
3686|NCT03237663|"     Cholera is an acute enteric infectious disease caused by the bacterium Vibrio cholera,     leading to watery diarrhea and loss of fluids from the small intestines. The World Health     Organization (WHO) estimates that up to 4.3 million cholera cases annually with more than     100,000 of them result in death in worldwide. Cholera is mainly caused by the O1 or O139     serogroups of V. cholera. Vaccination has been shown to be a cost‒effective, more immediate     option for cholera control and prevention. Injectable vaccine is not recommended by the World     Health Organization (WHO) mainly because of its limited efficacy and short duration of     protection. However, the inactivated whole-cell, bivalent O1 and O139 cholera vaccine have     provided evidence of substantial protective efficacy. With the goal of making an ideal     low-cost OCV that could be used in cholera-endemic countries, a phase I trial was conducted     to estimate safety of the oral O1 / O139 cholera vaccine (enteric capsules).   "
3687|NCT03237650|"     Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a     significant pain relief and decrease of evoked potentials and has been used to analyze     conditioned pain modulation (CPM). However, it is unknown whether the pain relief results     from habituation to the repeated painful electric stimulation. We compared the effects of CPM     and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether     increased attention by a random change of electric intensities amplifies the habituation     effects.   "
3688|NCT03237637|"     Through this study, the investigators shall compare the effectiveness of atenolol with     propranolol in the treatment of IH. In addition, the investigators shall try to elucidate the     mechanism of action of beta blockers by assessing their action on triggers such as hypoxia.     The study design will be a parallel group comparative study wherein patients of IH will be     randomized into two groups. One group will receive propranolol and the other atenolol for a     maximum period of 9 months. The patients will then be followed up regularly for regression of     the IH based on Physician global assessment, hemangioma activity score(HAS), serial     photography and lesional ultrasonography. Any side effects encountered during the treatment     period will also be noted. Also serial measurements of hypoxia inducible factor 1     alpha(HIF-1α) will be made to ascertain the mechanism of action of the drugs.   "
3760|NCT03236688|"     Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of     MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e.     abiraterone and enzalutamide)   "
3692|NCT03237585|"     AIM: To assess the community level impact of the Gender Centre's Rural Response System (RRS)     in reducing violence against women (VAW) in Ghana.      METHODS:      Design: An unmatched cluster randomised controlled trial with two arms i) Intervention arm-     Receive Gender Centre's RRS /COMBAT package for communities as well as state agencies.     Control arm - No intervention. Qualitative component Setting: Rural and urban communities in     the Central Region of Ghana. i). Rural and urban communities in four (4) Districts located in     the Central Region of Ghana. Two districts are along the Coast (Abura and Komenda) while the     other two (Agona and Upper Denkyira) are inland districts.      ii). State Agencies (DOVVSU/Police, CHRAJ, Social Welfare, and Health Services).      Interventions: Carried out in two Districts - Agona district and Komenda district. Workings     of the intervention arm will be facilitated by the Gender Studies and Human Rights     Documentation Centre in Ghana.      Sample size: A total of 3280 adults (1640 women and 1640 men) from 20 clusters per trial arm     (approximately 82 households per cluster) will be recruited at baseline and again at     post-intervention survey. Sampling format will be a community survey with independent samples     design (i.e. in each community, the people surveyed at baseline may not necessarily be the     same people who are surveyed at post intervention. Clusters refer to the selected localities     and their participating communities in each district.      Evaluation design: Pre-test all study participants with a standardized instrument then     introduce the independent variable (intervention) to the experimental group while withholding     it from the control group. After 24 months of intervention, post-test both groups with the     same instrument and under the same conditions as the pretest (baseline). Compare the amount     of change in dependent variable for both experimental and control groups.      Data analysis: The data will be analysed by intention to treat. The past 12 months prevalence     of IPV will be compared between arms in the study.   "
3693|NCT03237572|"     This pilot study evaluates the use of high-intensity focused ultrasound (HIFU) combined with     pembrolizumab in patients with metastatic breast cancer. One-half of participants will be     randomized to receive the first dose of pembrolizumab after HIFU and one-half of participants     will be randomized to receive their first dose of pembrolizumab before HIFU.   "
3694|NCT03237559|"     A Descriptive study to assess the knowledge, attitude and practice regarding eugenics among     eligible couples of selected area of Ambala, Haryana, India. Eligible couples were the     married couples where wife is in the age group of 15-45 years planning for conception, have     conceived and may or may not have any living child.Eugenics are to methods that are adopted     by eligible couples for having physically and psychologically healthy conception and     pregnancy.   "
3695|NCT03237546|"     The purpose of this randomized, un-blinded study is to determine if serratus blocks or     Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This     study will compare two standard of care pain management options and the patients narcotic     requirements in the immediate postoperative period.   "
3696|NCT03237533|"     Background: Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous autoimmune     disease mainly affecting stratum basal of the epithelium. It is very painful and hamper the     daily routine of patients e.g. (talking, drinking, eating, maintaining normal relationships).     Different topical treatments have been tried for the symptomatic relief of OLP which include     topical corticosteroids (TCSs), topical calcineurin inhibitors (TCIs) retinoids,     photochemotherapy; amitryptaline; thalidomide; amlexanox and traditional medicines such as     curcumin, selenium-ACE combined with itraconazole, glycyrrhiza glabra and aloe vera. But the     exact treatment is still unknown.      Objective: To compare the efficacy of Dexamethasone, Doxycycline, Nystatin and Promethazine     cocktail with Triamcinolone as topical treatment of OLP Subjects and Methods: 40 patients of     symptomatic OLP will be randomly divided in to study and control group. Study group will be     given a cocktail containing dexamethasone, doxycycline, nystatin and promethazine and will be     advised to rinse with 1 and half teaspoon of this cocktail 3 times a day for 2 minutes for     the period of 8 weeks. Study group is also advised to apply an orabase containing 0.1%     triamcinolone on lesions 3 times a day for the period of 8 weeks. The control group will be     advised to apply only triamcinolone orabase 3 times a day for 8 weeks.   "
3697|NCT03237520|"     This study intends to compare the efficacy of of virtual reality therapy(VRT) with modified     constraint induced movement therapy(mCIMT) versus modified constraint induced movement     therapy alone for children with hemiparetic cerebral palsy aged >/= 5-18 years, in improving     the upper limb functions, as measured by the QUEST (Quality of Upper Extremity Skill Test     score) over 3 months of intervention.   "
3698|NCT03237507|"     This is a non-interventional study，aim to observe the safety and efficiency of different     treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world   "
3699|NCT03237494|"     Estimation of the prevalence of TTR in patients with polyneuropathy or cardiomyopathy     undetermined etiology   "
3700|NCT03237481|"     This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled,     multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via     local administration into the surgical site in subjects undergoing unilateral open inguinal     herniorrhaphy.   "
3701|NCT03237468|"     Study looks to determine effectiveness of neck strengthening to reduce the incident,     duration, and severity of sports related concussion in student athletes.   "
3711|NCT03237338|"     Insomnia disorder is one of the major neuropsychiatric diseases which received more attention     in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid     (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of     insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture     can generate treatment effect on insomnia symptom. However, the underlying mechanism remains     unclear. The principal objective of this project is to use magnetic resonance spectroscopy     (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA     levels between pro- and post-acupuncture treatment in individuals with chronic insomnia     disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to     determine whether CID patients have altered brain connectivity and network parameter changes.     The investigators are also exploring the correlation between cortical GABA levels, fMRI     parameter changes and abnormalities in sleep parameters and neuropsychology test in CID     patients.   "
3765|NCT03236623|"     Thirst is defined as the desire to drink water. The perception and satiation of thirst     constitute an interconnected network of neuronal, physiological and hormonal mechanisms that     act simultaneously. In the oropharyngeal cavity are ionic channels called Transient Receptor     Potential Melastatin 8 stimulated by cold temperatures and menthol, which aid in the control     and decrease of the thirst intensity for providing refreshment and satiety without, however,     the necessity of fluid intake In high amounts.   "
4471|NCT03227315|"     Preoperative anxiety level of patients affects postoperative analgesic consumption. However,     there were no studies that showed a relationship between the level of stress tolerance and     analgesic consumption in the literature. In this study, investigators wanted to investigate     the effect of stress tolerance on analgesic consumption of patient.   "
3702|NCT03237455|"     Diffuse idiopathic skeletal hyperostosis (DISH) is a poorly understood, systemic condition     characterized by progressive calcification and ossification of ligaments and entheses. The     current classification criteria allow diagnosing the disease in its late course, when     significant bony overgrowth already involves the vertebral column and the appendicular     skeleton. The research of the pathogenic mechanisms in DISH, is significantly hampered by the     late diagnosis resulting from this definition.Based on recent MRI studies in both axial     spondyloarthritis (axSpA) and in DISH, it seems that changes similar to the classical early     inflammatory changes described in axSpA, can be detected in patients with DISH. We therefore     hypothesize, that patients with metabolic syndrome without radiographic evidence for spinal     DISH, might exhibit early MRI changes. If this hypothesis proves to be correct, early     diagnosis and research of the possible pathogenetic mechanisms at this early stage might be     very rewarding in investigations of the early aberrations of the entheses homeostasis and     eventually early, more targeted therapeutic interventions. The study will examine MRI changes     in patients, in their 5th decade of life, with high risk for the development of DISH (ie     diabetes mellitus, metabolic syndrome) compared with patients who don't have this risk.   "
3703|NCT03237442|"     Ocular chemical burn is one of the causes of vision loss in China, and there are no     satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the     biological characteristics of self-renewal, immune regulation, multidirectional     differentiation and tissue repair. Our preliminary research showed that in corneal alkali     injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The     aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal     burn in human.   "
3704|NCT03237429|"     Arterial hypotension during induction of general anesthesia is a risk factor for developing     postoperative cardiovascular complications. After induction of general anesthesia patients     have a high risk of developing arterial hypotension due to anesthetic drugs who can depress     cardiac contractility and determine vasodilatation. Previous studies have shown that even     short periods of hypotension with a mean arterial pressure of less than 55 mmHg during     surgery is associated with an increased incidence of cardiac injury and acute kidney injury     in the postoperative period.      The volemic status of the patients in the preoperative period is very difficult to quantify     and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting.     Bioimpedance is recognized by over 30 years as a simple and non invasive technique to     determine the volemic status especially in the hemodialysed patients. A new device BCM- Body     Composition Monitoring (Fresenius Medical Care) offers a simple method to determine     extracellular water and total body water. These volumes are determined by measuring impedance     at 50 different frequencies thru electrodes placed at the ankle and wrist. BCM can also     determine lean tissue mass and adipose tissue mass.      Increasing arterial stiffness is the main characteristic of arterial aging; this increase     determines the increase of the afterload, left ventricular hypertrophy, the decrease of     coronary and tissue perfusion. Arterial applanation tonometry is a non-invasive technique     that has been shown to reliably provide indices of arterial stiffness.      In this study investigators wish to determine if there is a correlation between the hidric     status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor     system and the development of hypotension during induction of general anesthesia. The     measurements will be obtained before induction of general anesthesia in the pre-surgical     area. During induction of general anesthesia with standard induction agents and Bispectral     index monitoring, brachial blood pressure will be measured by a cuff every minute after the     loss of verbal contact with the patient up to ten minutes after tracheal intubation. A     hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below     55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the     patient before the surgery.      Measurement of the hidric status and aortic stiffness may represent a valid indicator of the     risk of hypotension during anesthesia induction.   "
3705|NCT03237416|"     Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and     Pgp substrate   "
3706|NCT03237403|"     Specify the association between clinical criteria transmitted by non-medical emergency     services to the regulation of the SAMU centre call in patients with suspected sepsis and     their hospital orientation: emergency department or intensive care unit   "
3707|NCT03237390|"     This phase I trial studies the side effects and best dose of ribociclib and gemcitabine     hydrochloride in treating patients with solid tumors that have spread to other places in the     body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving ribociclib and gemcitabine     hydrochloride may work better in treating patients with solid tumors.   "
3708|NCT03237377|"     This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus     tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic     radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the     pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is     deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the     durvalumab/thoracic RT combination is established, a second cohort investigating the     combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be     opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as     deemed appropriate by the treating investigator.   "
3709|NCT03237364|"     The goal of this study is to evaluate the utilization of conventional 'thermally' polarized     perfluorinated gases mixed with oxygen as an exogenous inert contrast agent to image the     airway spaces in subjects with suspected lung disease, post deployment in Iraq and     Afghanistan. This is an open label proof of concept study expanding on work here at Duke.   "
3710|NCT03237351|"     Perioperative fluid management is a key component of anesthetic management during thoracic     surgery. On one hand, fluid restriction could compromise perfusion of vital organs and     surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary     complications, notably pulmonary edema, which carries a high mortality rate. Perioperative     fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed.     Therefore, to achieve the balance between preventing fluid overload and optimising organ     perfusion, the practical index to guide fluid management, which can predict whether fluid     loading will improve haemodynamic conditions in an individual patient, would be very valuable     during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of     tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory     variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure     variation] can predict fluid responsiveness in mechanically ventilated patients under various     conditions. Therefore, pressure variations are increasingly being advocated for fluid     management.This study will discuss the effects of pulse pressure variation(PPV) in different     level during anesthesia on patients with oxygenation index and short-term prognosis     undergoing video-assisted thoracoscopic surgery for pneumoresection.   "
3761|NCT03236675|"     Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation     from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.   "
3713|NCT03237312|"     In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological     appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity.     At that time wedge resection of the ovaries was introduced on an empirical basis and proved a     successful treatment for the associated anovulation and infertility. In the ensuing fifty     years the limitations of a purely surgical approach to therapy have become recognized and the     importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary     Syndrome: The prevalence of polycystic ovary syndrome in any specified population is     dependent upon the diagnostic criteria used, but does have some regional and ethnic     variation. While most reports on the prevalence of polycystic ovary syndrome range between 2     and 20%, the chosen diagnostic criteria are recognized to influence the determined     prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to     decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been     done to use the level of anti-mullerian hormone as a factor for planning the number of     ovarian drills in each ovary.   "
3714|NCT03237299|"     To study the association between several exposures of interest and the occurrence of     infectious loco-regional complications of pharyngitis in children.   "
3715|NCT03237286|"     This study has two aims: 1) to characterize the effects of intravenous ketamine on     neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic     intervention for depression combining intravenous ketamine with neurocognitive training.   "
3716|NCT03237273|"     Ultrasound represents a promising technique for the assessment of joint health in persons     with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy     Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating     joint ultrasound in the routine assessment of PWH through the use of a simplified scoring     system. The inter-operator reliability of the technique among European haemophilia treaters     has been validated and described elsewhere. Further work is needed to assess the real-world     impact of ultrasound on disease management and treatment decision-making.   "
3717|NCT03237260|"     The purpose of this research study is to determine whether starting the drug vedolizumab     earlier than its FDA approved use can lead to better control of UC then using older drugs     that we have historically used to treat UC. Vedolizumab is FDA-approved to be used after     initial Corticosteroid treatments have failed or other UC treatments have failed. We will     study if using vedolizumab as an early treatment for your UC will allow you to get off     corticosteroids and prevent UC from worsening and requiring surgery.      Vedolizumab is given intravenously initially every 2 weeks and then every 8 weeks.   "
3718|NCT03237247|"     Cases with extrahepatic cholestasis are common and faced during day to day clinical practice,     however reaching the final etiology is sometimes challenging and needs investigations which     are usually expensive, may carry hazards to the patients, or inaccessible so we are in need     for a method which is easily available, affordable and safe for aiding in the differential     diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete     blood count in predicting the etiology of extrahepatic cholestasis.   "
3719|NCT03237234|"     For many people with spinal cord injury (SCI), the goal of walking is a high priority. There     are many approaches available to restore walking function after SCI; however, these     approaches often involve extensive rehabilitation training and access to facilities,     qualified staff, and advanced technology that make practicing walking at home difficult. For     this reason, developing training approaches that could be easily performed in the home would     be of great value. In addition, non-invasive brain stimulation has the potential to increase     the effectiveness of communication between the brain and spinal cord. Combining motor skill     training with brain stimulation may further enhance the restoration of function in persons     with SCI. Based on these findings, the primary aim of this proof-of-concept study is to     inform future intervention development. To meet this aim, we will determine if     moderate-intensity, motor skill training can improve walking-related outcomes among persons     with SCI and to determine if the addition of non-invasive brain stimulation will result in     greater improvements in function compared to training alone.   "
3720|NCT03237221|"     Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that     threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of     breath, chest tightness and cough, usually occurring at night or early morning. However,     there are still some patients with only persistent clinical manifestations of chest     tightness. Concerned about this group of patients, we presented a subgroup of bronchial     asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks     asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and     therefore often misdiagnosed for a long time. In order to further understand the clinical     characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national     multicenter observation study to further understand CTVA. Finally, we plan to clarify whether     CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and     perform an appropriate treatment of CTVA.   "
3721|NCT03237208|"     The aim of the present trial was to investigate the analgesic efficacy and safety of     Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the     emergency department.   "
3722|NCT03237195|"     Most patients with cancer of the head and neck are offered surgical resection of the primary     tumor. In order to determine how the tumor will eventually behave, along with the resection     of the primary tumor, lymph nodes present in the neck are also dissected. Different     institutes have different protocol on handling of the specimen that is received by the     pathology labs after dissection of the neck. We intend to analyze the protocol that we use to     evaluate the neck dissection specimen.   "
3723|NCT03237182|"     This is a randomized controlled clinical trial comparing treatment success of a gene-derived     individualized drug-resistant Tuberculosis regimen to a standard Tuberculosis regimen based     on South African National Tuberculosis guidelines.   "
3724|NCT03237169|"     To test the feasibility and diagnostic accuracy of a new automated pressure derived resting     index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive     physiological evaluation is warranted.   "
3725|NCT03237156|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and     pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male     subjects.   "
3726|NCT03237143|"     Introduction: Erectile dysfunction occurs in a high percentage of patients today, showing not     only an association with various pathologies but also frequent refractoriness to conventional     pharmacological treatment options such as monotherapy. The objective of this study is to     evaluate the response to low-intensity extracorporeal shock wave therapy in a group of     patients with organic vascular erectile dysfunction with a history of more than three months.      Materials and Methods: Observational retrospective study. The researchers reviewed clinical     records of patients with a clinical diagnosis of organic vascular erectile dysfunction (ED)     of more than 3 months duration, who received 5 outpatient shock wave therapy sessions, in the     male sexual health clinics of the Boston Medical Group from Spain and Mexico. The patients     were evaluated with the erection hardness score (EHS) before the first session, at the end of     the last session and one month after the last session.   "
3727|NCT03237130|"     This study proposes to establish a CT radiomics-based prediction model for identifying     metastasis lymph nodes in esophageal cancer.   "
3728|NCT03237117|"     105 infertile women are enrolled in the randomized controlled trial: 70 women with a history     of RIF with donated oocytes and 35 infertile women undergoing the first oocyte donation     attempt. Women receiving donated oocytes are treated with progressively increasing doses of     oral estradiol followed by intravaginal progesterone after previous pituitary desensitization     with GnRH agonist. 35 RIF patients are treated with GH (GH patients) while the rest 35 RIF     patients (non-GH patients) and 35 first-attempt patients (positive control group) are not.   "
3729|NCT03237104|"     Half of all adolescents report experiencing low back pain (LBP), and adolescents who are     active in sport report an even higher rate. The most common identifiable cause of LBP in the     adolescent athlete is a stress fracture in the low back, known as a spondylolysis.     Spondylolysis injuries have been found in up 47% of young athletes with LBP. The current     recommendations of care for a spondylolysis consist of rest for at least 3 months, bracing,     and physical therapy. These recommendations result in athletes being out of sport for as long     as 46 months, and are based on low level evidence and expert opinion. In addition to the long     period out of sport, 42% have poor long-term outcomes, and 1 in 6 athletes are no longer able     to play at their former level specifically due to their back injury. These long periods out     of sport and poor long-term clinical outcomes suggest current care recommendations are     suboptimal.      The overall objective of the proposed research is to test the feasibility of using an early     functional progression program to reduce athletes' time out of sport and improve clinical     outcomes. Specifically, to pilot altering the rest period in athletes with a spondylolysis     and begin rehabilitation immediately. These young athletes will return to sport as they are     able, after demonstrating predetermined pain free functional ability. Twelve young athletes     with a confirmed active spondylolysis will be recruited to undergo the early function     progression intervention. The specific aims of this study are to assess the feasibility of     implementing the immediate functional progression protocol, refine the protocol if necessary,     and estimate potential effectiveness of this intervention. The athletes' outcomes will be     compared to historical controls. The investigators hypothesize that the immediate functional     progression program can be successfully implemented and with only minor changes will be     suitable for use in larger trials. It is estimated the immediate functional progression     program has the potential to return athletes to sport more than a month sooner than current     practice. Once able to demonstrate the feasibility of the early functional progression     program, the investigators plan to progress this work into larger trials to fully assess     effectiveness, safety and long-term outcomes.   "
3730|NCT03237091|"     Research indicates that increasing brain excitability might help improve hand function in     people with spinal cord injury. Brain stimulation that uses electrodes placed on the surface     of the scalp (also called non-invasive brain stimulation) increases brain excitability and     has the potential to make it easier for the brain and nervous system to respond to arm and     hand training. The purpose of this study is to compare four different types of stimulation     for increasing brain excitability to determine which types are best for helping people with     tetraplegia improve their ability to use their arms and hands. To fully evaluate the value of     brain stimulation on arm and hand function, the investigators will also evaluate the effect     of sham (fake) stimulation. Each participant will receive a single session of each of the     five types of stimulation being tested.   "
3731|NCT03237078|"     Recent studies have suggested that gut-brain axis may be one of the mechanisms of major     depression disorder (MDD). In animal studies, alteration of gut microbiota can affect     animal's depression or anxiety-like behavior, brain neurochemistry and inflammation. In human     studies, the composition of gut microbiota is different between patients with MDD and healthy     controls. In addition, supplementation of probiotics can improve mood status in community and     clinical participants. Inflammation is one of possible pathway to connect gut and brain. Gut     permeability and inflammation level are higher in patients with MDD. Lactobacillus plantarum     PS128 in one of bacteria extracted from traditional fermented food, Fu-Tsai. It can alleviate     depressive-like behavior reduce inflammation level in maternal separation mice. This study is     an 8-week open trial to investigate the effects of Lactobacillus plantarum PS128 on     psychophysiology in patients with MDD and higher level of inflammation.      This is a two-phase study. In the first phase, we will recruited patients fulfilling the     following inclusion criteria: Age 20-65; fulfill Diagnostic and Statistical Manual of Mental     Disorders fifth version (DSM-V) criteria of major depressive episode in recent 2 years;     Psychotropics including antidepressants, antipsychotics and hypnotics have been kept     unchanged for at least 3 months. The exclusion criteria are: comorbid with schizophrenia,     bipolar disorder, or other substance use (except tobacco) disorder; having active suicidal or     homicidal ideation; known allergy to probiotics; comorbid with hypertension, diabetes     mellitus, irritable bowel syndrome, inflammatory bowl disease, liver cirrhosis, or autoimmune     diseases; known active bacterial, fungal, or viral infections in one month; use of     antibiotics, steroid, immunosuppressants, probiotics, or synbiotics in the month before     collecting blood and fecal samples; pregnant or lactating women; who state to have dietary     pattern changed or in diet within previous two months. Those hs-CRP > 3 mg/L in the first     screen will be invited into the second phase intervention. In the second phase intervention,     we will give eligible patients Lactobacillus plantarum PS128 for 8 weeks, and compare     depression symptoms, gut microbiota, gut inflammation and permeability, and serum     inflammation level before and after intervention.   "
3732|NCT03237065|"     Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency     anaemia and comparison of the incidence of hypophosphatemia.   "
3733|NCT03237052|"     This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics     treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world     psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per     day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main     purpose of this study is to explore the potential difference between modal-aided-decision     with clinician-decision in order to validate and optimize the selection model that has been     established in advance.      The efficacy evaluations include symptoms, social function, recurrence rate and     hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.   "
3762|NCT03236662|"     This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in     patients with Becker muscular dystrophy who participated in the earlier trial. This single     center study will enroll up to 10 adults who will receive the purified nutritional extract     (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be     enrolled in the study if they meet all inclusion criteria. They will be evaluated at     screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the     study will be presence of one or more biologic or strength and performance outcome measures     that yield a response magnitude that allows for sufficient power in a Phase II B study with a     sample size of 30 individuals.   "
3763|NCT03236649|"     The primary efficacy index of this study is to compare the OS of the two groups.   "
3734|NCT03237039|"     Principal aim The main purpose of the study is to describe the distribution of the sagittal     profile in elderly subjects in order to bridge the gap present in this type of screening,     evaluated in the literature for adults only (i.e. 160 subjects considered by Roussouly et al.     in 2005). This classification assigns an integer value from 1 to 4 in relation to the     evaluation of alignment of the lumbar spine and pelvis in the sagittal plane. The population     description is therefore divided into four categories. The extension of this classification     to elderly can provide useful support for the clinical evaluation and the specific treatment     of the elderly patients.      Secondary aims The study aims in addition to evaluate the relation between the spine sagittal     profile and the objective indexes obtained from the assessment of fall-risk and gait cycle     analysis. Accordingly, a subgroup of 40 subjects out of the 160 will be evaluated. This     subgroup will consider the subjects older than or equal to 74 years, where the risk of     falling is most likely to be expected.   "
3735|NCT03237026|"     Prostate cancer (PC) afflicts millions of men worldwide. In Taiwan, around 5,000 men are     diagnosed as PC while 1,200 men die of the disease each year. Although there is a significant     advance in the definitive treatments of PC, the failure rate is still up to 40%. Androgen     deprivation therapy (ADT) and chemotherapy (Chemo) are palliative and rarely curative.     Immunotherapy brings on promise but is highly unpredictable. Thus, markers that predict     treatment outcomes may help decision making and prompt early adjuvant or salvage therapy.     Also, markers that mediate resistance to treatments may become druggable targets.      This is a prospective and observational clinical study investigating urine metabolites via     metabolomics analysis in subjects who will undergo therapy for PC. The treatment modalities     include radical prostatectomy (OP), prostate radiotherapy (RT), systemic Chemo, and ADT. The     expected subject number to be enrolled is 360 men from NTUH. There will be 2 cohorts:     training cohort (Cohort A, N=180), and validation cohort (Cohort B, N=180). Each cohort     consists of patients treated with OP (N=50), RT (N=70), Chemo (N=30) and ADT (N=30). Cohort A     will be recruited in the first 12 months of the study period to generate the first batch of     urine metabolite profiles. Cohort B will be recruited in the second half of the study period     to validate the first batch of newly developed urine metabolite profile.      Pre-treatment and post-treatment clinic-pathological parameters will be recorded. Group     specific urine metabolite profiles will be constructed by comparing the outstanding     metabolites between groups. These metabolite profiles are constructed so as to efficiently     separate outcome groups, especially to predict subjects with good prognosis and response to     the treatment. The newly constructed metabolite profiles will be validated against another     cohort of subjects who will receive therapy for PC to determine the predictive efficiency of     the constructed profiles. In addition, paraffin blocks of the prostate cancer will be used to     identify progression markers for invasion and metastasis, as well as progression markers for     castration-resistant PC.      Through a better understanding of the biology of PC, we hope to develop new markers/targets     for more effective predicting outcomes of PC. In the meantime, we can also substantially     develop a better decision-making tree of PC.   "
3736|NCT03237013|"     The purpose of the intended proposed research is to investigate and determine best strategies     for preventing skin cancer for emerging adults. To answer this question, the investigators     intended to pilot a randomized control trial with three arms: 1) Facial Morphing, 2)     Mindfulness, and 3) Treatment as usual. The population from which the sample was drawn from     was undergraduate psychology students from a large public university in Southern California,     who report recent indoor/outdoor tanning, and intentions for future tanning.   "
3737|NCT03237000|"     Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a     consistent approach of interpretation of traces. Paper speed of 3cm per minute will be     adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and     mode of delivery will be labelled on CTG.      Magnesium sulphate was administered by continuous intravenous infusion according to our     hospital protocol as follows:        -  Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered          over 15-20 min.        -  Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after          delivery.      Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading     MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels   "
3738|NCT03236987|"     MAC lung infections are a growing public health problem. The ATS / IDSA 2007 guidelines for     the treatment of these non-tuberculous mycobacterial infections recommend the use of a     macrolide or azalide (clarithromycin or azithromycin), rifampicin or rifabutin and     ethambutol.      For MAC disseminated infections, several studies have compared combinations containing     clarithromycin or azithromycin and found no significant difference in efficacy. No randomized     controlled trials have been performed for pulmonary infections to compare clarithromycin and     azithromycin in terms of efficacy. Clarithromycin is often used as a first-line treatment in     France, but its tolerance is often poor, particularly in terms of risk of hepatitis, metallic     taste in the mouth, nausea or vomiting, and it interacts with many drugs via cytochrome p450     . In particular, it increases the toxicity of rifabutin, in particular in terms of uveitis.     Azithromycin has fewer side effects especially less digestive toxicity and drug interactions     than clarithromycin.      The hypothesis is therefore that the efficacy of azithromycin would be non-inferior in     comparison with that of clarithromycin.   "
3739|NCT03236974|"     This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare     and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with     estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2)     negative (HER2-) primary breast cancer.      Patients will receive AZD9496 or fulvestrant and will have an on-treatment image-guided core     biopsy after 5-14 days of commencing treatment.   "
3740|NCT03236961|"     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.     Appendicectomy, however, includes operative and postoperative risks despite being a routine     procedure. Several studies have proved promising results of the safety and efficiency of     antibiotics in the treatment of acute uncomplicated appendicitis. The APPAC study by the     investigators, published in 2015 in the Journal of American Medical Association, also proved     promising results with 73% of patients with uncomplicated appendicitis treated successfully     with antibiotics. None of the patients initially treated with antibiotics that later had     appendectomy had major complications. The results of the APPAC trial suggest that CT proven     uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe     first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead     to significant economic savings.      The aim of this randomized prospective study is to optimize antibiotic therapy for     uncomplicated acute appendicitis by comparing different antibiotic regimens; intravenous     antibiotic (ertapenem) followed by per oral antibiotic (levofloxacin and metronidazole) with     only per oral antibiotics (moxifloxacin). Before randomization, the diagnosis of acute     uncomplicated appendicitis is confirmed with a CT scan.      The hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital     resources are not necessary for the treatment of uncomplicated acute appendicitis and that     per oral mono therapy is non-inferior to the combination of intravenous and per oral     antibiotic therapy.   "
3742|NCT03236935|"     The purpose of this Phase Ib study is to test the safety of NG-monomethyl-L-arginine (L-NMMA)     and pembrolizumab when used together in participants with melanoma, non-small cell lung     cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma     (cHL), urothelial carcinoma, or microsatellite instability-high (MSI-H)/mismatch repair     deficient (dMMR) cancer. Pembrolizumab is a type of treatment that stimulates the immune     system to attack cancer cells. The immune system is normally the body's first defense against     threats like cancer. However, sometimes cancer cells produce signals like programmed death-1     (PD-1) that prevent the immune system from detecting and killing them. Pembrolizumab blocks     PD-1 so your immune system can detect and attack cancer cells. To help further boost the     cancer-fighting ability of your immune system, L-NMMA will be used along with pembrolizumab.     L-NMMA is a nitric oxide synthase inhibitor. The presence of nitric oxide synthase in the     area around the cancer cells blocks the cancer-fighting ability of the immune system. Thus,     the use of L-NMMA and pembrolizumab together may make the immune system work harder to attack     and destroy the cancer cells.   "
3743|NCT03236922|"     It is clear from multiple accounts in the literature that patients with a vesico-vaginal     fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of     residual incontinence. Performing subsequent surgeries after the initial VVF repair risks     additional complications. Therefore, placement of an autologous sling at the time of initial     VVF repair would not only assist in covering the fistula, but would also imitate the     physiologic support that would theoretically improve urethral function. A rectus fascia sling     would most naturally provide this support and warrants testing against the success of the PC     sling.      Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the     urethra. Therefore, this group of patients is the target population for this study. As there     is currently no standard of care for repairing large urethral defects, this procedural     technique combined with otherwise standardized fistula repair would not introduce any     foreseeable harm to patients.   "
3744|NCT03236896|"     A prospective randomized pragmatic trial will be used to obtain data on energy expenditure,     temperature changes and vasomotor symptoms at baseline, during the intervention in which     participants will be randomized to either exercise or to not exercise, and at the end of the     12-week intervention.   "
3745|NCT03236883|"     To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell     transplantation in the treatment of pancreatic cancer.   "
3746|NCT03236870|"     The objective of this non-interventional, observational study is to assess the effectiveness     and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in     real world clinical practice in China.   "
3747|NCT03236857|"     An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of     venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended     Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and     young adult participants with relapsed or refractory malignancies.   "
3748|NCT03236844|"     The purpose of this study is to assess the relative bioavailability of the high concentration     liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the     same HCLF of gantenerumab produced with the G3 process in healthy participants following     single SC dose administration.   "
3749|NCT03236831|"     The investigators are doing this research to find out if more careful assessment and     elimination of potential risk factors of acute kidney injury (AKI) during the subject's     perioperative period will reduce their chance of kidney damage and kidney damage related     problems.   "
3750|NCT03236818|"     In this prospective long term feasibility study we examine whether a goal oriented     therapeutic strategy that is able to preserve right ventricular function will result in     improved clinical outcome in patients with pulmonary arterial hypertension. We hypothesize     that right ventricular function can only be preserved when early and aggressive medical     combination therapy not only reduces pulmonary vascular resistance but also pulmonary     pressures.   "
3751|NCT03236805|"     This is a prospective, randomized, single-blind trial evaluating prehospital patients     experiencing moderate to severe acute pain, defined as a numeric rating scale score greater     than or equal to 5. Patients will be randomized to receive ketamine at or morphine by     intravenous push.   "
3752|NCT03236792|"     Light chain (AL) amyloidosis is a bone marrow disorder that affects a wide range of organs     that can lead to organ dysfunction and death. Amyloid is an abnormal protein that is produced     in your bone marrow and cannot be broken down. It builds up in different organs preventing     them from working well. The most commonly affected organs are the kidneys, heart, liver,     spleen, nervous system, and digestive tract. Treatment with chemotherapy can stop the growth     of abnormal cells that produce this abnormal protein. Decrease in amyloid protein in the body     improves the function of the affected organs.      The primary purpose of this study is to determine the safest dose of the medications and how     well you tolerate them or the maximum tolerated dose (MTD). The study uses Ixazomib in     combination with cyclophosphamide and dexamethasone to treat people with newly diagnosed AL     amyloidosis. This combination of medications is an oral regimen that is taken over 6 cycles.     The first part of study will determine the safety of this regimen and the second part of the     study will determine how effective this combination of drugs is to treat your disease.   "
3753|NCT03236779|"     This is a clinical trial that will be done in the state of Kuwait, at the physical     rehabilitation medicine hospital. the participants will be recruited from all over Kuwait,     there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of     health.   "
3754|NCT03236766|"     This study will enroll 100 Samoan and 100 Marshallese adults to discuss mental health, mental     disorders, and approaches for engaging Pacific Islander adults with mental illness into     mental health services.   "
3755|NCT03236753|"     This clinical trial is designed to evaluate the efficacy and safety of thread-embedding     acupuncture on lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and     quality of life.   "
3756|NCT03236740|"     This study is undertaken to compare the effects of treatment with commonly used OCP     containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special     attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and     they will be correlated with changes in hormonal parameters post-treatment.   "
3766|NCT03236610|"     Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant     chronic ehpatitis B patients who achieved a complete virological response to entecavir and     tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy     for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA     while on tenofovir plus entecavir combination therapy.   "
3767|NCT03236597|"     The purpose of this study is to:        1. Evaluate the relative efficacy of a treadmill desk intervention and a sit/stand desk          intervention on light physical activity and sitting behaviors at work over four weeks;        2. Evaluate the relative efficacy of a treadmill desk intervention and a sit/stand desk          intervention on the cardiometabolic risk profiles (composite measure of fasting glucose,          insulin, triglycerides, HDL-cholesterol, and blood pressure)over a four-week period.   "
3768|NCT03236584|"     Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant     chronic hepatitis B patients who achieved a complete virological response to lamivudine plus     adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy     for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus     DNA while on lamivudine plus adefovir combination therapy   "
3769|NCT03236571|"     Marfan syndrome (MFS) is a rare genetic disease (1/5000) characterized by the association of     ocular impairment, cardiovascular disease and musculoskeletal disease.      In some chronic conditions, physical activity and training have been shown to be effective in     improving muscle strength and functional abilities but also fatigue and quality of life. We     hypothesize that the implementation of a personalized exercise rehabilitation program     (Personalized Training Program) in children and young adults with MFS, by improving muscle     mass, physical endurance, muscle strength, bone mass and quality of life of these patients.     In order to test this hypothesis, investigators wish to carry out an interventional,     prospective, monocentric study for the first time in children and young adults (<25 years     old) presenting an MFS.   "
3770|NCT03236558|"     Regulatory T lymphocytes play a major role in the protection from autoimmune pathology.     Defects in immunosuppression mediated by these cells is therefore suspected to contribute to     these diseases. This issue has very little been studied in humans.Regulatory T cells     emigrated from the thymus will be isolated from the blood of patients and healthy controls.     The repertoire of antigen-receptors will be analysed by high throughput sequencing and its     diversity estimated using appropriate statistical models borrowed from ecology.   "
3771|NCT03236545|"     The purpose of the study is to identify the independent effect of estradiol (E2) on     endothelin-1 (ET-1) mediated vasomotor function in women. The study is the first step in     recognizing the impact of ovarian hormones on the mechanisms that regulate vascular function     in women to provide a better understanding of the cardiovascular efficacy of hormone therapy.   "
3772|NCT03236532|"     This study aimed to investigate the effect of an exercise session with weights associated     with glutamine dipeptide (GLD) supplementation on cognitive function of people living with     HIV/ AIDS. The sample consisted of 10 HIV+ women, who used the Antiretroviral Therapy Highly     Active. The participants were randomized in a double-blind procedure to receive seven days of     supplementation GLD or placebo (PLA). At the end of this first period, the participants held     a workout with weights with cognitive assessments before and immediately after the session.     To evaluate oxidative stress markers blood samples were collected before and 1 hour and 2     hours after the session.Then the participants rested for 7 days for the initial stocks of     glutamine return to baseline levels (washout). Following was realized the crossing of the     groups, so those who had received the GLD in the first week spent extra for 7 days with PLA     and vice versa, and then they repeated evaluations and exercise session. The exercise session     consisted of seven resistance exercises involving different muscle groups, with three sets of     8-12 repetitions with an interval of 90 seconds between sets and 120 seconds between the     exercises. Stroop test was used to cognitive assessments, which aims to assess selective     attention and inhibitory control over the color of conflict and word, and the N-back test,     responsible for evaluating the central executive component of working memory by stimuli     visual. Oxidative stress markers (TBARS, FOX, GSH, GSSG, AOPP) were analyzed in plasma     samples.   "
3773|NCT03236506|"     Hepatitis C is a blood borne virus that can seriously damage the liver. An estimated 50,000     Scots have been infected with Hepatitis C virus (HCV). The main driver for spread of HCV     infection is intravenous drug use. As HCV is highly infectious by the blood borne route     through needle sharing, it can infect the person who injects drugs (PWID) early in their     habit.      Around two thirds of people who are infected are unaware of it, and often show no symptoms     over a long period of time. While there is presently no vaccination for Hepatitis C, improved     treatments with shorter duration are now available. This raises the possibility of using     therapy as prevention, turning the epidemic off at source, by targeting active PWID who are     the main source of new infections. Modelling work illustrates the startling possibility and     impact of treating drug users to reduce the prevalence of HCV.      The focus of this trial will be to ascertain whether oral treatment regimens are effective in     the treatment as prevention scenario in an active PWID population where illicit drug taking     and poor adherence may reduce treatment efficacy. The investigators will trial 3 different     methods of delivering treatment and will trial an unlicensed combined treatment against HCV     genotype 3 infection of shortened duration since current regimens for this genotype are     limited.      The investigators will recruit 135 participants and randomise them to one of three arms:     daily, directly observed therapy; fortnightly dispensing of drugs; fortnightly dispensing of     drugs with a psychological adherence intervention. Randomisation will be stratified according     to HCV genotype. Participants will be treated for 12 or 8 weeks depending on genotype and     followed up 12 weeks post treatment for the measurement of sustained viral response (SVR).     The primary outcome measure will be SVR at 12 weeks post treatment (SVR12), as this measure     of cure is the determinant of sufficient compliance and efficacy within the 3 treatment arms.     Analysis will be by modified intention to treat of all participants who receive one dose of     therapy, to show non-inferiority fortnightly dispensing is easier to deliver than daily     dispensing.   "
13689|NCT03106259|"     Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe     rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.   "
3798|NCT03236181|"     The purpose of this study is to evaluate the effect of dietary fat on satiety (the experience     of fullness between one meal and the next) and energy metabolism over an extended period of     time (chronic effects). How dietary fat sources affect satiety, appetite and energy use is     unclear. The investigators will use a controlled setting for the studies. They want to know     if the source of dietary fat alters satiety, satiety hormones, and energy expenditure     responses after consuming different diets.   "
3799|NCT03236168|"     This is a pilot study evaluating if treatment for scabies also treats headlice in the same     community   "
20052|NCT03023085|"     The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel     preparation prior to colonoscopy in adult patients.   "
3775|NCT03236480|"     Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur     together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel     disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no     history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS     patients have pulmonary involvement, such as inflammation or impaired lung function.     Increasing evidence indicated chronic gut and lung disease share key conceptual features with     the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms     are not well understood.      Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract     and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the     immune responses in the lungs, and vice versa.   "
3776|NCT03236467|"     The most recent conflicts are creating a new generation of Veterans, including an increasing     number of women Veterans, who present with comorbid PTSD and chronic pain conditions,     including Fibromyalgia (FM), from deployment-related physical injuries and exposure to     psychological trauma. Health behavior change is important in treating these conditions and     proactively preventing long-term negative health sequelae, in order to benefit these Veterans     directly and reduce the challenges to our healthcare system. The proposed SPiRE application     will use an innovative translational research approach to study whether a progressive -based     exercise program will reduce FM pain in patients with PTSD and to elucidate and modify     potential PTSD-related deficiencies in neurobiological and psychological responses to     exercise to optimize the physical and psychological benefits of exercise for these     individuals.   "
3777|NCT03236454|"     This 2-armed randomized, sham-controlled, single-blind study aims at providing evidence for     the efficacy of a transcranial direct current stimulation (tDCS)-enhanced cognitive control     training (PASAT) in participants with subjective cognitive decline (SCD). Overall, the study     will include 30 participants. Each participant will take part in a four weeks training (12     sessions); 50% of the participants will receive 2mA anodal tDCS for 20 minutes applied to the     left dorsolateral prefrontal cortex (dlPFC), the other half will receive sham stimulation.     Event-related potentials (ERPs) evoked by the feedback on the correctness of the response at     baseline and after training will be measured with EEG as neurophysiological signatures of     cognitive control. Near and far transfer will be assessed by a verbal 2-back task and the     Trail Making Test A and B. The amount of worrying regarding the memory impairment will be     quantified by means of a 10 point Likert-Scale. Together with changes of PASAT performance     these measures will be obtained before and after the tDCS-enhanced training. Follow-up     assessments 3, 12 and 24 months after training will investigate the stability of training     effects.   "
3778|NCT03236441|"     This a prospective, double-blind, sham-controlled, randomized clinical trial to study the     effects of remote ischemic preconditioning on contrast-induced acute kidney injury, vascular     and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable     angina undergoing cardiac catheterization and percutaneous coronary intervention.   "
3779|NCT03236428|"     This research study is studying a drug as a possible treatment for Monoclonal Gammopathy of     Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM).      The drug involved in this study is:      -Daratumumab   "
3780|NCT03236415|"     Stents are used at centers around the world to unblock the arteries of the heart. These     stents are usually made of metal and remain permanently within the blood vessel wall. Newer     developments in the stent technology has led to stent scaffolds that can be reabsorbed over     time. Patients with diabetes are prone to more complex blockages in the heart arteries which     can be more difficult to treat. The purpose of this study is to compare the difference of how     arteries heal early when metal stents or resorbable stents are used in patients with     diabetes.   "
3781|NCT03236402|"     A cross - sectional comparative study to assess knowledge and opinion regarding adoption     among adults residing in rural and urban area of Ambala, Haryana.   "
3782|NCT03236389|"     Clinical trials have suggested that this device is effective in mitigating changes in brain     structure and function in athlete populations. The purpose of the current study is to better     understand the underlying mechanistic response of the brain hemodynamics to mild jugular vein     compression   "
3783|NCT03236376|"     Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor     impairments are present in 67% of the stroke patients, resulting in problems with     independency and performance of activities of daily life. In addition, the pattern of     recovery in the brain is still a matter of ongoing debate. Although the importance of     somatosensory function on motor performance is well described, evidence for somatosensory or     sensorimotor therapy and brain-related changes is scares. Therefore, we aim to explore the     effect of a sensorimotor therapy compared to pure motor therapy on motor function of the     upper limb. A second objective is to investigate therapy-induced brain-behavior associations     using resting state functional Magnetic Resonance Imaging of the brain.   "
3784|NCT03236363|"     Project which objective is to test the effectiveness of a classroom-based physical activity     intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and     executive function.   "
3785|NCT03236350|"     Chronic kidney disease (CKD) is one of the leading causes of death and disability in     Singapore and worldwide. Hypertension is commonly inadequately controlled in patients with     CKD and this is associated with CKD progression and cardiovascular complications. Daily     episodes of Remote ischaemic conditioning (termed chronic RIC or CRIC) using transient limb     ischaemia/reperfusion applied for 1 to 12 months have been shown to lower systemic blood     pressure (SBP), prevent stroke and reduce post-myocardial infarction left ventricular (LV)     remodelling in experimental and clinical studies. In the ERIC-BP-CKD feasibility and efficacy     study, we hypothesise that CRIC administered for 28 days will lower systemic blood pressure     and improve blood pressure control in patients with CKD and hypertension.   "
3786|NCT03236337|"     Project which objective is to test the effectiveness of an extracurricular physical activity     intervention based on high intensity interval training (MOVI-daFit!) on improving     cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic     performance.   "
3840|NCT03235622|"     A single center cohort which enrolled women who performed mammography, bone densitometry     (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March     2011 to February 2013.   "
3787|NCT03236324|"     The aim of this study is to assess the efficacy of a bilateral TFP block in parturients     undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric     rated pain scores in two groups (TFP block with saline (control) and TFP block with local     anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class     1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal     anesthesia at the South Health Campus will be consented to participate in the study. Patients     will be randomly assigned using a computer-generated table of random numbers to two groups.     Group allocations will be concealed. All patients will receive spinal anesthesia with spinal     Morphine according to our institutional protocol. At the end of surgery, randomized patients     will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5     mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2     anesthesiologists experienced in performing this block.   "
3788|NCT03236311|"     The Primary Objective of this study:      -To assess the effects of SAR407899 on coronary vasomotor function using the coronary flow     reserve (CFR) in patients with microvascular angina and/or persistent stable angina despite     angiographically successful elective percutaneous coronary intervention (PCI).      The Secondary Objectives of this study are:        -  To assess the effects of SAR407899 on quality of life using Seattle Angina Questionnaire          physical limitation domain (SAQ-PL) in patients with microvascular angina and/or          persistent stable angina despite angiographically successful elective PCI.        -  To assess the safety of SAR407899 in patients with microvascular angina and/or          persistent stable angina despite angiographically successful elective PCI with a focus          on identified risks such as hypotension and orthostatic hypotension.        -  To assess SAR407899 plasma concentrations in microvascular angina patients and/or          persistent stable angina despite angiographically successful elective PCI.   "
3789|NCT03236298|"     At Mount Sinai Hospital, epidural analgesia for labor pain is delivered by programmed     intermittent epidural bolus (PIEB), in combination with pushes of medication activated by the     patient, a technique called patient controlled epidural analgesia (PCEA). Studies have shown     that delivering analgesia in this manner can prolong the duration of analgesia, diminish     motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and     decrease local anesthetic consumption comparing to a conventional continuous infusion. The     use of this PIEB technique in routine practice has reduced the total consumption of local     anesthetic and the percentage of patients requesting additional boluses (PCEA or manual     rescues).      However, at the same time, sensory blocks above those targeted for labor pain relief have     been reported in our institution, suggesting that the spread of the freezing medication is     wider than necessary. Based on the information already available in the literature, the     investigators will conduct this study to determine the best regimen of PIEB achievable with a     slower delivery speed.      The hypothesis of this study is that PIEB boluses with 125 mL/h will decrease by 50% the     incidence of women presenting sensory block to ice equal or higher than T6 as compared to a     delivery rate of 250 mL/h.   "
3790|NCT03236285|"     The study investigates the effects of high intensity interval training (HIIT) versus     continuous training (CT), combined or not with fasting, on capillary density, microvascular     function, cardiometabolic risk markers, functional capacity, and quality of life, in     overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could     promote greater improvements in these parameters than CT. Furthermore, the positive effects     of exercise may increase when it is performed in the fasting state, compared to exercise     performed in the fed state.   "
3791|NCT03236272|"     The aim of the investigators 'study is to investigate the relationship between the biomarkers     (e.g. protein markers, genetic polymorphisms and epigenetic markers) and the onset of ARDS.     In this study, the participants were divided into case group (with ARDS) and control group     (without ARDS), based on a nested case-control study method. During the diagnosis and     treatment, the clinical data of subjects are collected at the given time point. And the     clinical data are extracted from plasma, blood and bronchoalveolar lavage fluid of     participants. These data will be analyzed based on statistical methods. In the end ,the     investigators can build a multi index early warning model based on the biomarkers,which is     meaningful for the early diagnosis of the patient with high-risk for ARDS and provide     evidence for the early treatment.   "
3792|NCT03236259|"     The purpose of this study is to investigate the effects of daily supplementation of Brainport     for a period of 6 months on cognitive health.   "
3793|NCT03236246|"     The objectives of this study are to assess the long-term efficacy and safety of different     dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects     with non-dialysis dependent chronic kidney disease (CKD).   "
3794|NCT03236233|"     This study investigates the safety, tolerability and pharmacokinetics of single and repeat     doses of PC786.   "
3795|NCT03236220|"     The aim of the study is to evaluate the efficacy of the prophylactic administration of     N-acetyl-L-cysteine (NAC) in acute leukemia patients with complete remission pre- and     post-allotransplant on the occurrence of poor graft function (PGF) and prolonged isolated     thrombocytopenia (PT) after haploidentical hematopoietic stem cell transplantation.     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment of     malignant hematopoietic diseases. However, the delayed hematopoietic reconstitution,     including PGF and PT, remain serious complication after allo-HSCT, and the effective     therapeutic strategies are limited. In murine studies, endothelial cells have been identified     as a key cellular component supporting hematopoietic stem cells in the bone marrow     microenvironment. Our previous prospective nested case-control study suggested that the     frequency of bone marrow endothelial cells was markedly reduced in patients with PGF or PT.     Moreover, our recent study further identified reduced bone marrow endothelial cells (<0.1%)     pre-allotransplant was associated with significant higher incidences of PGF or PT after     allo-HSCT. In addition, NAC treatment in vitro could quantitatively and functionally improve     bone marrow endothelial cells derived from the patients with PGF or PT. Therefore, bone     marrow endothelial cells (<0.1%) pre-allotransplant can be used to identify patients with a     higher incidence of PGF or PT to provide timely prophylactic intervention of NAC to prevent     the occurrence of delayed hematopoietic reconstitution post-transplant. The study hypothesis:     Prophylactic intervention of NAC pre- and post-allotransplant could reduce the incidence of     PGF and PT in acute leukemia patients after haploidentical hematopoietic stem cell     transplantation.   "
3800|NCT03236155|"     The United States constitutes <5% of the world's population but over 80% of the opioid supply     and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug     overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids.     Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood     of readmission for pain. Available data suggests that orthopaedic surgeons are the most     likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are     over 7 times more likely to come from an orthopaedic surgeon than another type of physician,     but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many     studies have investigated the utilization of opioids after surgery to assess surgeon's     tendencies to overprescribe, demographics of those likely to overuse, and adverse events of     opioid abusers.      The primary purpose of this randomized controlled trial is to determine whether prescribing     fewer opioid pills per prescription reduces the total amount of opioids taken, even while     allowing equal total opioid availability via increased frequency of prescription     availability.   "
3801|NCT03236142|"     The aim of this study is to answer the question of whether the single anastomosis, 300 cm     loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less     nutritional and surgical risks than the standard duodenal switch (DS) operation.   "
3802|NCT03236129|"     The investigators have previously shown the absence of toxicity of Treg-depleted-DLI and the     possibility to triggering alloreactivity (GVHD/GVT) in relapsing patients dealing with     hematological malignancies who had never shown any signs of GVHD after transplant or after     one or more DLI.      The Investigators, we plan to demonstrate the benefit of Treg-depleted DLI as compared to the     reference treatment of relapse in hematological malignancies after allogeneic HSCT which is     currently based on standard DLI   "
3803|NCT03236116|"     This study will examine the effects of almonds consumed by adults with different body fat     distributions on indices of carbohydrate and lipid metabolism.   "
3804|NCT03236103|"     The investigators are doing this research to investigate whether multifaceted preventive     measures for newly hospitalized ventricular assist device (VAD) patients will reduce the     Acute Kidney Injury (AKI) occurrence rate, progression and associated complications   "
3805|NCT03236090|"     Study Design:      Double-blind randomized placebo-controlled clinical trial      Study Duration:      2 years      Study Center:      Single center Hospital de la Santa Creu i Sant Pau, Barcelona      Objectives:      To assess the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in     patients with cirrhosis   "
3806|NCT03236077|"     Despite decades of physical activity (PA) research on inactive, obese individuals, we have     not successfully moved the needle on exercise participation in this population. A recent     review aptly referred to PA recommendations among obese individuals as the public health     guideline that is (almost) entirely ignored[1]. While we have previously had little     understanding of why PA rates are so low in this population, Dr. Leone's research uncovered     two possible explanations: (1) women with obesity are less likely to report enjoying exercise     and (2) more likely than non-obese women to report exercising only when they are trying to     lose weight. In order to affect change among obese women, we need interventions that not only     address disparities in enjoyment and outcome expectations. Programs must also be practical     and scalable; however, these types of evidence-based programs do not exist within the context     that people generally exercise (e.g., community centers, gyms). We propose a novel approach     to increasing exercise participation in this population by focusing on exercise enjoyment,     increasing appreciation of the proximal benefits of PA rather than focusing on weight, and     addressing changes to the exercise environment that make it conducive to this population. By     delivering our intervention in partnership with the YMCA, we not only have the ability to     make changes to a typical exercise context, but we also ensure that our findings can be used     to help exercise-focused community organizations implement a scalable, research-tested     program.   "
3807|NCT03236064|"     This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.   "
3808|NCT03236051|"     The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's     wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets'     oral administration on postoperative pain and rehabilitation after laparoscopic radical     gastrectomy for patients with gastric cancer.   "
3809|NCT03236038|"     Exocrine pancreatic insufficiency (EPI) is the inability of the pancreas to perform a normal     digestive function. The prevalence of IPE in patients with decompensated hepatic cirrhosis     (HC) is unknown and most published series are short, old and use a single diagnostic     technique with potential risk of false positives and negatives. Demonstrating IPE in a     patient with HC can change their vital prognosis with the indication of pancreatic enzymes     that can improve their nutritional status and help control their decompensations.      Objectives: To assess the prevalence of IPE in patients with decompensated CH. To establish     correlation between fecal elastase and 13C triolein breath test.      Methodology: Unicentric, transversal study that will be carried out during hospitalization.     Patients with HC who enter for decompensation and requiere hospitalization will be included     consecutively. Exclusion criteria will include prior diagnosis of IPE, suspicion of biliary     obstruction, more than 5 dep / d induced by laxatives or liquid stools.      The diagnosis of IPE will be made with the combination of two techniques (13C triolein breath     test and fecal elastase).      Demographic, epidemiological data, clinical data as well as anthropometric parameters will be     collected. A blood test will also be done to assess nutritional status and associated     deficits. A multivariate analysis will be performed to assess the predictive factors of IPE   "
3841|NCT03235609|"     comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric     diagnostic gastrointestinal endoscopy.   "
3811|NCT03236012|"     This project will address a problem that has troubled Service members, Veterans, and     civilians with amputations for decades, impacting satisfaction with prosthetic use, residual     limb skin health, and negatively affecting quality of life. Prior research in this area has     been limited and insufficient. We are confident that improving the evaluation and treatment     of residual limb hyperhidrosis will reduce the secondary health consequences of amputation     and will lead to improved quality of life.   "
3812|NCT03235999|"     Up to 20 patients with malignant pleural effusions will be interviewed about their     experiences of having this condition and its management.   "
3814|NCT03235973|"     The investigators focused on patients with refractory acute leukemia or MDS and designed a     phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided     myeloablative busulfan doses. This scheme allows combining different optimization of RTC     experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine     analog cladribine) to approach a specific platform to treat refractory diseases.   "
3815|NCT03235960|"     Despite numerous techniques for enamel protection, occlusal caries still remains a problem.     Sealing pits and fissures is considered to be an effective way of preventing caries     development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for     two reasons. First, they are less susceptible to moisture which allows their use in     noncooperable children or in partially erupted teeth where isolation could be a problem, and     secondly, due to their potential to act as a fluoride reservoir making enamel more resistant     to demineralisation. The purpose of the study is to clinically examine the caries-preventive     effect of a glass-ionomer material for fissure protection in newly erupted permanent molars     in children with low, moderate, and high caries-risk.   "
3816|NCT03235947|"     A clinical controlled, randomized and double blind trial that included adult patients (≥18     years) receiving kidney transplantation (KT) at the INCMNSZ.      The intervention group will receive disodium fosfomycin 4 g intravenously in three moments:     preoperative of transplant surgery, prior to removal of the urinary catheter and finally     prior to removal of ureteral catheter. The control group will receive placebo in the same     moments.      Both groups will receive prophylaxis standard for urinary tract infection (UTI), with     trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once     the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2.      The primary objective is to compare the average number of episodes of UTI´s and asymptomatic     bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know     the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the     days of hospital stay, the pattern of bacterial resistance, the safety of disodium     fosfomycin, and assessment of the function of the graft and rejection rate.   "
3817|NCT03235934|"     This pilot study aims to evaluate the feasibility of close glucose monitoring and management     of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art     flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized     based on individual blood glucose levels. Although the glycemic interventions used in this     study include standard medications and methods of glucose monitoring used for patients with     diabetes, this pilot study will specifically evaluate the feasibility of using these     approaches in patients with GBM, appreciating their additional medical, functional and social     challenges.   "
3818|NCT03235921|"     Hemorrhagic shock is a pathologic state in which intravascular volume and oxygen delivery are     impaired. During circulatory failure associated with hypovolemia and low cardiac output,     redistribution of blood flow caused by increased vasoconstriction results in decreased     perfusion of the skin.      Skin temperature and capillary refill time has been advocated as a measure of peripheral     perfusion.   "
3819|NCT03235908|"     An acute psychotic episode is a severe psychiatric syndrome which might occur in different     psychiatric diagnoses.      The outcome prediction of relapse rate of a psychotic episode within a certain time frame is     difficult and depends on many factors. More and better predictors are required to improve the     outcome prediction in order to adjust therapy and follow-up if patients suffer from this     acute disease.      Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of     the outcome in serious somatic diseases. Additionally, a rise of copeptin due to     psychological stress was shown.      The aim of this study is to investigate the association of the neuroendocrine biomarker     copeptin and the prediction of the onset of psychotic episode within one year.   "
3820|NCT03235895|"     A randomized controlled Trial to evaluate the internet based CME for wet cupping providers in     Saudi Arabia   "
3821|NCT03235882|"     The aim is to validate a FTIR spectroscopy test for measuring lung maturity/Respiratory     Distress Syndrome (RDS) in terms of safety, usability, and efficacy.      The purpose is to accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio     determined by a rapid FTIR test on fresh gastric aspirates) using retrospective analysis.      Research question:      In very preterm newborn infants with (risk of) respiratory distress who have not received     prophylactic surfactant: does analysis of L/S-ratio in fresh gastric aspirates using a rapid     FTIR test predict RDS requiring exogenous surfactant with sufficient specificity and     sensitivity to be clinical useful?   "
3822|NCT03235869|"     This is a single arm, single stage pilot study of radiation therapy plus durvalumab for     tumor-stage cutaneous T-cell lymphoma (CTCL).   "
3823|NCT03235856|"     The purpose of this study is to create a database of keratoconic eyes with two or more     corneal topographies/tomographies, at least 5 months apart   "
3836|NCT03235674|"     This study will evaluate the effect of brief, intermittent stair climbing exercise on key     cardiovascular and metabolic markers of health in individuals completing a cardiac     rehabilitation program. Participants of this study will be placed into one of two exercise     groups: one group will perform the standard exercise protocol currently being used by the     Cardiac Health and Rehabilitation Centre at Hamilton General Hospital and the second group     will perform a variation of interval exercise training, high intensity interval stair     climbing.   "
18106|NCT03048526|"     Patients with mild to moderate dry eye disease will be randomized to receive either     NovaTears® or Hydrabak® eye drops as control.   "
3824|NCT03235843|"     The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over     pilot study in a multi-center setting.      Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial     stimulation to restore functional capacity and quality of life in heart failure patients with     chronotropic incompetence.      Methods: heart failure patients (left ventricular ejection fraction ≤35% & New York Heart     Assessment II or III) who were implanted with a 2-chamber implantable cardioverter     defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic     incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to     rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3     months the pacing mode will be switched to the opposite mode.   "
3825|NCT03235830|"     The overall goal is to assess the feasibility and effectiveness of using text messages as an     educational tool in order to improve health care utilization among the parents and caregivers     of newborns; in particular, the investigators seek to understand how educational text     messages counteract the effects of low health literacy as it relates to non-urgent visits to     the emergency department.   "
3826|NCT03235817|"     The purpose of this research study is to compare difference between breathing by oneself or     with the partial help from an anesthesia machine in infants under general anesthesia.      Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated     (improved breathing) with the help of the breathing machine versus breathing on their own.   "
3827|NCT03235804|"     This study will investigate the effects of a 12-week high-protein diet on individuals with     excessive body weight in adult men and women on metabolism and gut microbiome.      This is a randomized, parallel group, single-blind, placebo-controlled clinical trial of a     12-week nutritional intervention. A sample size of n=72 participants will be randomly     allocated into one of the following groups:        -  Control group (CON): Participants will maintain their usual dietary intake over 12          weeks;        -  High-protein group (HP): Participants will maintain their usual dietary intake and          consume a portion of a yogurt and honey-based soy-protein nutritional supplement twice          daily (as two snacks) over 12 weeks.      The following variables will be analysed:        -  Systemic inflammatory biomarkers (high-sensitivity C-reactive protein [hs-CRP], IL-6,          IL-8, IL-10, tumor necrosis factor-α [TNF-α] and adiponectin).        -  Energy metabolism (i.e. resting energy expenditure and RQ);        -  Metabolic blood markers [glucose, insulin, lipid panel, PYY, GLP-1, ghrelin, leptin,          free glycerol, free fatty acids, and thyroid stimulating hormone (TSH)];        -  Appetite sensations (hunger, satiety, fullness, and prospective food consumption);        -  Body composition;        -  Gut microbiome diversity and composition, specifically taxa that have been associated          with health benefits, obesity, and weight loss.      At baseline and after 6 and 12 weeks, individuals will attend our Human Nutrition Research     Unit where all assessments will take place. In order to assess participants' adherence and     follow-up, dietary intake, body weight and appetite sensations (only for participants     assigned to the HP group) will be assessed weekly during the 12-week intervention period.     Additionally, participants will be contacted by phone weekly and reminded to maintain their     journal/log.   "
3828|NCT03235778|"     1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol          Injection on multiple dose and single dose        2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with          Felbinac Trometamol Injection on multiple dose and single dose   "
3829|NCT03235765|"     Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of     patients is rapidly becoming established as a useful source of information to aid clinical     decision-making. This study is aimed to to compare concordance rate between tissue based     cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by     NGS technique).   "
3830|NCT03235752|"     This is a multicenter, randomized, double-blind, placebo-controlled phase II study.      The trial includes a Run-in Period (if stable conventional treatment needed), a 4-week     Screening Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day     105.      90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive     600mg TJ301 biweekly (Q2W), 300mg TJ301 Q2W or placebo Q2W. TJ301 or placebo administrations     will occur on Days 0, 14, 28, 42, 56, and 70. Randomisation will be stratified by prior     corticosteroids treatment (yes/no) and consent to participate in PK substudy (yes/no).   "
3831|NCT03235739|"     The purpose of this study is to find out whether oral Naloxegol can reduce the side effects     of opioid painkillers following surgery. This study aims to explore whether Naloxegol can     similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery     patients will participate in this study which is being conducted at Cleveland Clinic Main     Campus.   "
3832|NCT03235726|"     This single and repeat increasing dose study will collect information on safety, tolerability     and drug levels in the body of the CCI15106 inhalation powder. The study will also look at     the level of CCI15106 that will be released into the air and may be found in the blood of the     people standing around the person inhaling it (bystanders). This is a two-part study in which     Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part     2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and     approximately 22 subjects with COPD will be randomized in this study for dosing. The total     study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C     Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.   "
3833|NCT03235713|"     The study aims to (1) evaluate the effectiveness of the recent renewal of tobacco health     warnings (HWs) on noticing and anti-smoking responses, and (2) assess the effect of exposure     to point-of-sale (POS) tobacco displays and smoking hotspots on nicotine-craving intensity     and smoking-related behaviors. The study will use time-based system-triggered ecological     momentary assessments to collect real-time data about exposures to smoking-related cues and     behaviors. With a smartphone app installed in the mobile phones of the participants, they     will each day complete at least 3 pairs of EMA prompted randomly for only 2 days (a working     and a nonworking day). Outcomes include exposure and responses to tobacco HWs, exposure to     POS tobacco displays, exposure to smoking hotspots and smoking and quitting outcomes.   "
3834|NCT03235700|"     Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients     with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the     major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in     patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment     using a coronary pressure wire.   "
3835|NCT03235687|"     The purpose of this research study is to investigate the utility of a validated urine test     which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.   "
18107|NCT03048513|"     Melioidosis in head and neck was observed including clinical presentation, diagnosis with     titer, and result of treatment.   "
3842|NCT03235596|"     It's an interventional, prospective and monocentric pilot study concerning adult patients     with autism without mental retardation.      The primary outcome is to assess the effects of cathodal transcranial direct current     stimulation (tDCS) on the left dorsolateral prefrontal cortex (DLPFC) on the executive     functions of patients with autism without mental retardation or with Asperger syndrome.      The secondary outcomes are to evaluate the safety of this treatment and to evaluate its     impact on impaired social communication and on restricted or repetitive behaviors.   "
4472|NCT03227302|"     In China, the standardized training system for residents was built last year, and the     associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.   "
3843|NCT03235583|"     In this study, the investigators propose to assess the validity in measuring physical     activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn     multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope)     with an automatic activity/posture recognition algorithm and an activity-specific multilinear     prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure     (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly     labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns     will be compared to those of two existing activity or movement monitors: the triaxial     accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with     accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the     cost of a calibration of the heart-rate/EE relationship that limits its use in large     population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years     of both gender and with broad range of body mass index and physical activity level. The     subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total     of 14 days in everyday life conditions and complete a physical activity diary. In half of the     subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW.     The other 60 subjects will be studied twice, one month apart, to test the reproducibility of     the measures.   "
3844|NCT03235570|"     The purpose of this study is to evaluate the safety and tolerability of INCB054828 in     Japanese subjects with advanced malignancies.   "
3845|NCT03235557|"     Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.      Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate     Specific Antigen) <30ng/ml.      Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5     fractions, in 10 days, considering CAPRA Scores>5.      Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives :     PSA and MRI response.   "
3846|NCT03235544|"     This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of     2 INCB050465 treatment regimens in subjects with relapsed or refractory mantle cell lymphoma     (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.   "
3847|NCT03235531|"     Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma     centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is     collection of symptoms that can range from anxiety and restlessness to seizures, delirium and     even death. The Clinical Institute Withdrawal Assessment (CIWA) tool is routinely used to     assess alcohol withdrawal symptoms. Benzodiazepines (BZD) are commonly administered to trauma     patients who exhibit symptoms of AWS based on the CIWA scoring system. Although these     medications have proven efficacy, they can also have negative side effects which may affect     recovery. Valprate (VPA) is a medication which may have efficacy in management of AWS     symptoms, thus ameliorating or preventing the need for BZD administration. This trial will     study the effectiveness of VPA in the prevention of AWS symptoms by comparing the amount of     BZD use in trauma patients who receive BZD treatment as indicated by CIWA scores with     patients who receive prophylactic VPA therapy in addition to BZD as indicated by CIWA scores.   "
3848|NCT03235518|"     The purpose of this study is to conduct formative research to inform the design and     implementation of combination prevention interventions, including pre-exposure prophylaxis     (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention     strategies for female sex workers and their male clients in Kenya.   "
3849|NCT03235505|"     Abstract Rationale. Electronic cigarette use is increasing at an exponential rate in Finland     and internationally. The health consequences of vaporised aerosols in electronic cigarettes     are largely unknown especially in a long run. Still, very few studies are available on     quitting attempts with e-cigarettes as a smoking cessation tool compared to evidence based     cessation pharmacotherapy in adult smokers who want to quit.      Research Objective: To investigate effectiveness and safety of e-cigarettes for smoking     cessation in middle-aged smokers, and to compare the effectiveness of them to varenicline.     Our study provides new information of success in smoking cessation among heavy adult smokers     for clinicians.      Design: A double-blind, randomised, placebo-controlled clinical trial with the intervention     phase of 12 weeks and the observational phase up to 52 weeks. This is an investigator     initiated study.      Setting: Volunteer middle-aged daily smokers, who were recruited through newspaper     announcements. The majority of the cohort subjects (n=513)were recruited for our previous     follow-ip study during years 2003- 2009, and many of them continued daily smoking during the     whole follow-up period.      Participants: In all, 450 adult heavy smokers, who want to quit smoking and are willing to     participate up to 52 weeks´ follow-up.      Intervention and procedures: Standardized self-reported questionnaires with detailed smoking     history with assessment of motivation to quit smoking, parameters of nicotine dependence,     symptoms will be included. Smoking status will be repeatedly reassessed during the study     visits, and self-reported smoking abstinence is verified with exhaled-carbon monoxide (CO)     assessment. All adverse side effects either of drugs or of e-cigarettes, and symptoms related     to the drugs or to withdrawal from smoking will be carefully reported.   "
3851|NCT03235479|"     The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo     in subjects with Acute Migraines   "
3865|NCT03235297|"     The purpose of this study is to further understand the effects of altitude on the physiology     of gas exchange in the pulmonary microcirculation in normal subjects and in people with     chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity     for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for     altitude corrections in both study populations to be used clinically in pulmonary labs.   "
3898|NCT03234842|"     This study will evaluate if proton beam therapy as part of chemoradiation results in a     decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation     therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac     function, quality of life, and compare acute and late toxicities.   "
3866|NCT03235284|"     Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor,     postural instability and bradykinesia, which leads to alterations of balance, necessitating     specialized physiotherapeutic treatment. In this way this study aims to determine the     effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 36     patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index and Timed up     and go, and will then be randomized to receive 16 sessions of Kinesiotherapy or Nintendo Wii     alone or together. After this period the patients will be reassessed to verify the effects of     the techniques.   "
4473|NCT03227289|"     Acute respiratory distress syndrome in neonates has been defined in 2015. However, sparse and     conflicting evidence exists regarding mortality risk from pediatric acute respiratory     distress syndrome (ARDS).   "
3852|NCT03235466|"     This study seeks to explore whether heart rate variability (HRV) biofeedback can be effective     in the treatment of chronic cough. Chronic cough has many causes, including asthma, postnasal     drip, and gastroesophageal reflux disease (GERD), each with a specific treatment. However,     among a subset of cough patients, no clear cause is found despite extensive workup, and     traditional treatment methods do not provide relief. Several studies revealed less common     causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal     fold motion, and stress. Additional research identified links between the neurological     networks that produce the cough reflex and those that maintain normal breathing. HRV     biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate     and breathing, two key functions of the autonomic nervous system. By using this non-invasive     behavioral technique, cough patients can regulate their breathing and autonomic function,     potentially leading to improved autonomic balance and a reduction in cough symptoms.   "
3853|NCT03235453|"     The randomized clinical trial will aim to analyze the influence of binary and quaternary     rhythm through a protocol on motor symptoms, sleep, fatigue and quality of life in     individuals with Parkinson's disease. The study design with a randomized clinical trial,     including individuals diagnosed with Parkinson's Disease, will be divided into two groups: 1)     Control group 2) Experimental group. Cognition, balance, gait freezing, functional mobility,     quality of life, sleep, daytime sleepiness and fatigue will be evaluated. Through the     application of binary and quaternary rhythm protocol for a period of 12 weeks. First, the     descriptive statistics (mean, standard deviation and percentage) will be used to know the     data, then the normality calculation using the Kolmogorov Smirnov test will be used to choose     the statistical tests. All information will be collected before and after the intervention     period. For statistical analysis, use the SPSS statistical package, version 20.0.     (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of statistical tests.   "
3854|NCT03235440|"     This study will evaluate the effects of a one week weight management summer camp on     children's weight, quality of life, mood and feelings, self-esteem, weight management     efficacy, enjoyment of physical activity, and body image.   "
3855|NCT03235427|"     CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery     disease.      The purpose of CAROLE is to check the heart health of women who received breast cancer     treatments in the past and protect them from future heart disease.   "
3856|NCT03235414|"     MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring     of liver disease in the pediatric population. There is, however, little data specific to the     use of this technique in children with existing data and techniques largely extrapolated from     adult studies. Existing studies suggest that liver stiffness values may be different between     children and adults [Etchell, Xanthakos]. As such there is an unmet need for uniquely     pediatric data in both healthy and diseased cohorts. To address the need for such data, the     investigators plan a multi-site, prospective study of healthy pediatric (<17 years of age)     volunteers to determine normal liver stiffness measured by MR elastography across the range     of MRI equipment.   "
3857|NCT03235401|"     To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary     arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.   "
3858|NCT03235388|"     Audit filters for monitoring trauma care quality are regarded as one of the most essential     components of trauma quality improvement programmes; however, there is a paucity of evidence     that shows that audit filters are associated with improved outcomes. Therefore, our aim is to     assess if institutional implementation of audit filters reduce mortality in adult trauma     patients.   "
3859|NCT03235375|"     A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety,     tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.   "
3860|NCT03235362|"     This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the     pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers   "
3861|NCT03235349|"     This is a Phase 3, single-arm, open-label, multicenter study to evaluate the efficacy and     safety of ABT-493/ABT-530 in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected     Asian participants with compensated cirrhosis with or without Human Immunodeficiency Virus     (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN)     (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir     with RBV with or without IFN.   "
3862|NCT03235336|"     The China Health and Nutrition Survey (CHNS), an ongoing open cohort, international     collaborative project between the Carolina Population Center at the University of North     Carolina at Chapel Hill and the National Institute for Nutrition and Health (NINH, former     National Institute of Nutrition and Food Safety) at the Chinese Center for Disease Control     and Prevention (CCDC), was designed to examine the effects of the health, nutrition, and     family planning policies and programs implemented by national and local governments and to     see how the social and economic transformation of Chinese society is affecting the health and     nutritional status of its population. The impact on nutrition and health behaviors and     outcomes is gauged by changes in community organizations and programs as well as by changes     in sets of household and individual economic, demographic, and social factors.      The survey was conducted by an international team of researchers whose backgrounds include     nutrition, public health, economics, sociology, Chinese studies, and demography. The survey     took place over a 7-day period using a multistage, random cluster process to draw a sample of     about 7,200 households with over 30,000 individuals in 15 provinces and municipal cities that     vary substantially in geography, economic development, public resources, and health     indicators. In addition, detailed community data were collected in surveys of food markets,     health facilities, family planning officials, and other social services and community     leaders.   "
3863|NCT03235323|"     The aim of this study is to evaluate the effect of External CounterPulsation on postoperative     heart function and vein graft failure rates of coronary artery bypass grafting patients.   "
3864|NCT03235310|"     The purpose of this study is to describe over time the rate of mother to child transmission     of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate     the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV   "
3897|NCT03234855|"     This study is gathering opinions from surgeons on the usability of our laparoscopic measuring     device.   "
3867|NCT03235271|"     The aim of this pilot study is to collect data on stroke patients using the BrainPulse Stroke     Monitor. Patient characteristics, diagnostic procedures and clinical outcomes will be     documented as part of the data collected to assess the clinical utility of the BrainPulse     device. All eligible patients will be enrolled and assigned to a study Group based on     confirmation of their diagnosis: Acute Ischemic Stroke, Hemorrhagic Stroke, Transient     Ischemic Attack or No Stroke. The data collected from the BrainPulse will be compared across     the four different study groups in an attempt to distinguish stroke from other non-stroke     conditions that present with similar symptoms. Further assessments will also be made to     evaluate if the BrainPulse can distinguish between hemorrhagic and ischemic stroke.   "
3868|NCT03235258|"     The purpose of this study is to describe the conditions of access to early treatment of     children infected with HIV, their management on the long-term, and impact on growth, clinical     and immunovirological prognosis, adherence to treatment, living conditions   "
3869|NCT03235245|"     This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective     of this trial is to prospectively evaluate whether a sequential approach with an induction     period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with     nivolumab + ipilimumab improves progression free survival compared to combination     immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive     unresectable or metastatic melanoma.   "
3870|NCT03235232|"     The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the     treatment of primary open-angle glaucoma or intraocular hypertension.   "
3871|NCT03235219|"     The purpose of this Phase 1b study is to assess the safety and tolerability of JNJ-64565111     in adult men and women (of non-child bearing potential) with Type 2 Diabetes Mellitus.   "
3872|NCT03235206|"     This study is intend to show the positive impact that massage therapy can have on the lives     of police officers. The study will demonstrate how regular treatment can change sleeping     quality, stress levels and mental health. It will also investigate the impact that police     work can have on the body.   "
3873|NCT03235193|"     In this prospective study, the ability of a machine learning algorithm to predict sepsis and     influence clinical outcomes, will be investigated at Cabell Huntington Hospital (CHH).   "
3874|NCT03235180|"     The purpose of this study is to assess the effectiveness of a new ultrasound technology for     evaluating Crohn's disease.   "
3875|NCT03235167|"     to observe the outcome of hepatocellular carcinoma patients under the combination treatment     of transcatheter arterial chemoembolization (TACE) and CpG DNA   "
3876|NCT03235154|"     The main purpose of this pilot study is to investigate the safety, effectiveness and     tolerability of the study medication in the treatment of people with chronic hepatitis C     virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction     treatment.   "
3877|NCT03235141|"     To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the     original azithromycin eye drops, and evaluate the release behavior of both in the eye.   "
3878|NCT03235128|"     Childhood nephrotic syndrome is the most frequent glomerular disease that presents during     childhood,primarily owing to a disturbed immune function.This disease is characterized by     alterations in selectivity at the glomerular capillary wall that lead to an inability to     restrict the urinary loss of protein.   "
3879|NCT03235115|"     This study aims to compare the short-term clinical performance of the three contact lenses     (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).   "
3880|NCT03235102|"     This study aims to assess barriers that prevent obesity patients from receiving adequate care     for their condition. The non-interventional study will be administered in the form of a     30-minute, cross-sectional, online survey to various respondents. There is no experimentation     involved in the process of data collection, and each survey poses minimal human risk.      The study will evaluate lifestyle habits and weight management strategies perceived and/or     practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers,     and Employers. A customized survey will be administered to each of the 3 stakeholders, and     data will be analyzed based on respondents' answers.   "
3881|NCT03235076|"     To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal     impairment, stratified according to estimated glomerular filtration rate (eGFR) determined     2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to     assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose     of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.   "
3882|NCT03235063|"     Increasing cases of women with dilated cardiomyopathy with a project of pregnancy are     observed. However there is few knowledge and publications about cardiac diseases in pregnant     women. Moreover the majority of medical articles deal with women with congenital heart     diseases, valvular pathologies or peripartum cardiomyopathies, and few data are available in     literature about women with dilated cardiomyopathy diagnosed before or during the first     months of the pregnancy.      Cardiologist and obstetrician advices are considerably limited when patients with dilated     cardiomyopathy have a pregnancy project. Knowledges and know-how are currently based on     limited personal experiment or on few clinical cases descriptions.      Pregnancy represents a high-risk situation for patients with dilated cardiomyopathy. Creation     of a cohort of pregnant women with dilated cardiomyopathy collecting specific data will allow     to have a better overview and to appreciate possibilities of a pregnancy project, evolution     risks and modalities for medical attention and to improve follow-up and advices delivered to     these patients.   "
3883|NCT03235050|"     This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose     control and weight loss effects, as well as to further explore the safety profile of     MEDI0382.   "
3884|NCT03235037|"     The purpose of this study is to evaluate the safety and effectiveness (how well a drug works)     of Carbidopa/levodopa (Sinemet) in individuals with Angelman syndrome. Sinemet is a     medication that helps to raise dopamine levels (a chemical that signals nerve cells) in the     brain and central nervous system. There is evidence that dopamine concentrations may be     abnormal in patients with Angelman syndrome. This study is investigating whether Sinemet     helps motor control, intellectual function and the achievement of developmental milestones in     people with Angelman syndrome   "
3888|NCT03234985|"     Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and     consolidation. Standard chemotherapy combination for induction treatment associates     cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About     60-70% of patients achieved complete remission after this standard chemotherapy. As     cytarabine competes with endogenous nucleotides to exert its activity, the aim of this     protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of     the induction treatment. Thus, intracellular nucleotides levels will be determined in     peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment,     and results will be compared with the efficacy of the treatment. This parameter will be     assessed by the achievement of complete remission.   "
3889|NCT03234972|"     The primary purpose of this study is to compare the efficacy of daratumumab when combined     with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd),     in terms of progression free survival (PFS) in Chinese participants with relapsed or     refractory multiple myeloma (MM).   "
3890|NCT03234959|"     Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood     disabilities with high cost for individuals and society. Early Intervention (EI), if     intensive enough but affordable by patients, family and health services can improve its     outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in     gross and fine motor skills, visual development and parent infants interaction in preterm     infants. Recently, a new technological tool, called CareToy has been developed as a     tele-rehabilitation tool for delivering at home EI. The effects of CT training on     neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants     with very promising results. The aim of the project is to provide evidence, by a RCT, of the     efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12     months (or with motor competencies from initial head control to unstable sitting position) at     high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants     will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group     will perform a training with CT while the others will perform infant massage. Both trainings     will be carried out at home by parents with the monitoring of the therapists. Both     interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9     wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant     Motor Profile will be the primary outcome measure.   "
3891|NCT03234946|"     Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the     whole family. Hence, during the last decade, studies have focused mainly in the role of the     members of the family and their influence in life quality or clinical outcomes of patients     with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes     mellitus may restric the expectations of success in achieven the necessary modifications in     lifestyle.      Objectives: To assess the effect of the CAIPaDi program interventions on various health     indicators relatives of patients with type 2 diabetes mellitus   "
3892|NCT03234933|"     This research study is evaluating the postoperative results in terms of quality of life and     functional recovery of elderly patients after cancer surgery.   "
3893|NCT03234920|"     Sarcopenia is an independent predictor of morbidity and mortality in cirrhotic patient before     and after liver transplantation. Beta-hydroxy-beta-methyl butyrate (HMB) is a leucine     metabolite with potential efficacy in increasing protein synthesis, muscle mass and its     functionality.      The aim of this randomized controlled study is to evaluate the effect of a nutritional     supplementation with HMB after liver transplantation both on muscle mass and on muscle     function.   "
3894|NCT03234907|"     The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous     (IV) infusion as induction treatment in Chinese participants withmoderately to severely     active Crohn's disease (CD) at Week 10.   "
3895|NCT03234881|"     Inclusion Criteria: aged 21 and older, BMI>=25, and presence of recurrent binge eating on the     MOVE! Survey. Exclusion Criteria: more than 4 MOVE! sessions in the prior year; active     psychosis or suicidal ideation; medical or psychiatric illness, or cognitive deficits that     interfere with providing consent or completing assessments, and; pregnancy or lactation.      Participants will be recruited from the VA's MOVE! Program at VA Connecticut Healthcare     System (both Newington and West Haven campuses). Those participants who meet eligibility and     are interested in the study will meet with a research associate who will obtain written     consent. A baseline appointment will be made where the participant will complete written     assessments, anthropometric measures (weight, height, blood pressure etc.), along with a     blood draw. Participants will then be randomized, by luck of a draw, to either MOVE! or     MOVE!+gshCBT treatment.      For those randomized to the MOVE! condition, participants will continue in the MOVE! program     by meeting with the multidisciplinary team in a group setting once a week for 60 minutes, for     16 weeks. The group sessions are lead by a dietician, health psychologist, and physical     therapist.      For those randomized to the MOVE!+gshCBT treatments, participants will continue in the MOVE!     program as described above, but will also partake in 8 individualized sessions over a 3-month     period. Participants will be given a treatment manual to read at home, ask to complete daily     food logs and work with the study therapist to create goals and complete homework that is     geared at examining and changing how participant think about binge eating and how that     thinking affects behavior. Lastly, a walking program will also be incorporated into the     treatment.      For both treatment arms, 3 months from treatment starting, then again at 9 months and 15     months, participants will be asked to complete post and follow up assessments, much like the     baseline.   "
3896|NCT03234868|"     The aim of this research project is emphasize the benefit of the digital workflow compared to     conventional impressions and crown processing with standard la procedures. The objectives of     the present study are to measure and compare the global cost, the time spent in the dental     chair and in the lab and the fit of both digital and conventional workflow. Additionally,     patient centered outcomes will be recorded.   "
3900|NCT03234816|"     Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean     delivery with promising results ; However, the optimum dose for efficient prophylaxis with     the least side effects is not known. In this study, we will compare three doses (0.05, 0.1,     0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during     cesarean delivery.   "
3919|NCT03234569|"     This pilot study is a collaborative effort between Northwell Health's Departments of     Fertility and Radiology.The aim of this study is to evaluate the feasibility of the     Sonohysterosalpingography (sonoHSG) for it to be determined as the standard of care.     Additionally, it aims to improve the work up of infertility by integrating the examination of     structural abnormalities of the Fallopian tubes and uterus into a single radiation free     ultrasound guided procedure, the sonoHSG.   "
4474|NCT03227276|"     To evaluate the efficacy of Litramine in reducing body weight in the context of an     energy-restricted diet in overweight and moderately obese subjects   "
3901|NCT03234803|"     Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base     material because of its several advantages as; good esthetics, adequate strength, easy repair     and simple processing techniques. As any material it has some problems as polymerization     shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was     introduced into dentistry to be used as a denture base material in order to solve these     problems. Polyamide denture base materials have some superior properties than PMMA as; High     impact & flexural strength, excellent esthetics and less release of residual monomers4.     Although being an advantage from the point of patient satisfaction, flexural property     considered to be a contraindication for a denture base material.      The invistigators' trial is done in order to improve rigidity of a polyamide material as well     as to improve oral health related quality of life in comparison to heat cured polymethyl     methacrylate.   "
3902|NCT03234790|"     Strong scientific understanding of how emissions from diesel engines impact the lungs could     improve policies and regulations protecting workers exposed to diesel exhaust. Accordingly,     we are recruiting healthy volunteers who are non-smokers to participate in our study.     Volunteers sit in a room for four hours and breathe either clean filtered air or air that     contains pollution at various concentrations similar to occupational settings such as bus and     ferry terminals where diesel engines are used. A respirologist assesses the volunteer's lung     health and clinical samples are taken. We are equipped with advanced molecular biology tools     to measure different molecules and compare samples from our volunteer subjects following     exposure to clean air or diesel exhaust. Our research aim is to find a simple, clinically     relevant strategy that can be used to measure the impact of diesel exhaust on workers' lung     health. This knowledge will empower regulators, companies, and ultimately workers to better     manage their health risks. Our research aims to provide specific data to help regulators to     make informed decisions about the risks of diesel exhaust exposure.   "
3903|NCT03234777|"     Diarrhea and vomiting in children is a common reason to visit the emergency department. There     has been a lot of research on how best to treat children with diarrhea and vomiting who visit     the emergency department; however, the care children receive varies by healthcare provider     and across hospitals. Additionally, there are things parents can do at home to help manage     childhood diarrhea and vomiting and potentially avoid a trip to the emergency department.     This shows an urgent need for knowledge translation, that is, efforts to align research     knowledge and healthcare practice. Actively involving parents in healthcare decisions has the     potential to bridge this gap; however, there is little research on the best ways to     communicate complex health information to parents of sick kids. In 2013, a national needs     assessment was conducted with parents seeking care for their kids in general emergency     departments (trekk.ca). This survey showed that 39% of parents looked for information about     their child's health prior to coming to the emergency department and that 44% of these     parents looked for this information on the internet. This means that the development and     evaluation of digital tools to give parents timely and effective child health information has     the potential to reduce unnecessary emergency department visits, empower parents in health     decision-making, and ultimately improve child health outcomes. In this project, parents will     be actively involved in the evaluation of a digital tool, a whiteboard animation video,     designed to communicate the best research evidence on the treatment and management of     vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments     will be randomized to view the video or a sham video, and then provide quantitative and     qualitative data on the potential effectiveness of the video, the perceived benefit and value     of the knowledge translation intervention for pediatric vomiting and diarrhea, the     feasibility of using iPads and an electronic data collection platform to conduct research     with this population, the time required to complete data collection, and parents' willingness     to participate in future, similar research.   "
3904|NCT03234764|"     The purpose of this study is to evaluate the clinical usefulness of assessing specific human     allergy antibodies and other immunologic parameters associated with the diagnosis, evolution,     and management of allergic disease.   "
3905|NCT03234751|"     The purpose of the study is to compare the effects of nesiritide to placebo administered by a     continuous IV infusion over 48 hours for the treatment of insulin resistance in healthy,     obese, insulin resistant individuals.   "
3906|NCT03234738|"     This is a single-center, randomized, placebo-controlled, double-blind,     multiple-ascending-dose, inpatient study to assess the safety, tolerability, and     pharmacokinetics of TP‑271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the     inclusion/exclusion criteria will be enrolled in this study.   "
3907|NCT03234725|"     The aim of the present study is to develop and evaluate a computer-based methods for     automated and improved detection and classification of different colorectal lesions,     especially polyps. For this purpose first, pit pattern and vascularization features of up to     1000 polyps with a size of 10 mm or smaller will be detected and stored in our web based     picture database made by a zoom BLI colonoscopy. These polyps are going to be imaged and     subsequently removed for histological analysis. The polyp images are analyzed by a newly     developed deep learning computer algorithm. The results of the deep learning automatic     classification (sensitivity, specificity, negative predictive value, positive predictive     value and accuracy) are compared to those of human observers, who were blinded to the     histological gold standard.      In a second approach we are planning to use LCI of the colon, rather than the usual white     light. Here, we will determine, whether this technique could improve the detection of flat     neoplastic lesions, laterally spreading tumors, small pedunculated adenomas and serrated     polyps. The polyps are called serrated because of their appearance under the microscope after     they have been removed. They tend to be located up high in the colon, far away from the     rectum. They have been definitely shown to be a type of precancerous polyp and it is possible     that using LCI will make it easier to see them, as they can be quite difficult to see with     standard white light.   "
3908|NCT03234712|"     This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose     (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary     efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid     tumors likely to overexpress the epidermal growth factor receptor (EGFR) or its ligands. The     study will consist of 2 phases: Dose Escalation Phase and Expanded Safety Phase.   "
3929|NCT03234439|"     Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid     psychological distress are also commonly found among individuals living with chronic pain.     Often requiring a multi-modal treatment approach, a growing body of literature suggests that     digital behavioral health interventions and tools may serve as promising complementary     options to help individuals cope with the pain.   "
3920|NCT03234556|"     This randomized phase II trial studies how well systematic random biopsy or magnetic     resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate     cancer in patients with elevated prostate specific antigen. Systematic random biopsy and     MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.   "
20053|NCT03023072|"     The purpose of this study is to determine if the sponsor's Incontinence Product reduces     patient exposure time to a wet and/or soiled incontinence pad.   "
3909|NCT03234699|"     This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5,     CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo     probes. In order to avoid a potential pharmacokinetic interaction between the probes,     midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together     as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time     period between the 2 assessments.      The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2     weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg,     150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady     state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day     of cenobamate for all CYP probes.      The results of this DDI study will provide a basis to make appropriate dose recommendation     for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic     pathway.   "
3910|NCT03234686|"     This study is a phase 2, randomised, placebo-controlled, multicentre study to investigate the     safety and efficacy of Deferiprone in participants with Prodromal Alzheimer's Disease (pAD)     and Mild Alzheimer's Disease (mAD). In this phase 2 study, the investigators aim to determine     whether Deferiprone (15 mg/kg) slows cognitive decline in Alzheimer's patients. As secondary     outcomes, safety and iron levels in the brain will be evaluated.   "
3911|NCT03234673|"     Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well     circumscribed depigmented macules and patches that occur secondary to selective destruction     of melanocytes (Zhang et al., 2009).      Generalized vitiligo is the most common clinical presentation and often involves the face and     acral regions (Alikhan et al., 2011).   "
3912|NCT03234660|"     Neuroapoptosis is induced by the administration of anesthetic agents to the young brain.     Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role     during development and is neuroprotective in several settings of neuronal injury in animals.     We hypothesized that neuroprotective effect of dexmedetomidine would be associated with     evidence of brain injury detected by elevation of plasma concentration of glial fibrillary     acid protein in children undergoing general anesthesia.   "
3913|NCT03234647|"     Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.   "
3914|NCT03234634|"     This study is a prospective, partly randomized, multi-center, Phase III, controlled trial,     designed to show that the onset-to-puncture time (OPT) for good functional outcome (defined     by modified Rankin Scale score at 3 months, 0-2) can be set depending on collateral status     based on multiphase CT angiogram. The purpose of this study is to prove that (1) for patients     with poor collaterals, there will no difference in good outcome rate between endovascular     treatment and best medical treatment group if onset-to-puncture time is between 150 minutes     and 600 minutes, and 2) for patients wih good collaterals, the rate of good outcome is equal     to or greater than 42% (10% greater than historical control) if onset-to-puncture time is     between 150 minutes and 600 minutes. Patients will initially be classified into 3 arms based     on both collateral status on multiphase CT angiography and whether or not receiving     endovascular thrombectomy: group 1, patients with good collaterals and receiving endovascular     thrombectomy, 2) group 2a, patient with poor collaterals and receiving endovascular     thrombectomy, and 3) group 2b, patients with poor collaterals and not receiving endovascular     thrombectomy. Patients with good collaterals will receive endovascular thrombectomy (EVT) if     onset-to-puncture time is between 150 minutes and 600 minutes after last seen well time. Of     the patients with poor collaterals, they will be randomized into endovascular treatment and     best medical treatment group, if onset-to-puncture time is between 150 minutes and 600     minutes, (onset-to-puncture time is not possible within 150 minutes but possible within 600     minutes after last seen well). Primary endpoint is the rate of good outcome at 3 months. The     number of subjects needed with statistical power of 0.8 and alpha value of 0.025 is estimated     309 patients.   "
3915|NCT03234621|"     The purpose of this study is to find a proper ventilation strategy for one-lung ventilation     to prevent postoperative pulmonary complications   "
3928|NCT03234452|"     A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in     Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of     inflammation and intestinal barrier function and gastrointestinal symptoms in healthy     volunteers with self-reported anxiety.   "
3917|NCT03234595|"     A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety     and Efficacy Profile of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With     Recurrent High Grade Glioma.      High grade gliomas, glioblastoma multiforme (grade IV) and anaplastic anaplastic astrocytoma     (Grade III), are the most comment malignant brain tumor. The cause of gliomas remains     unknown. Despite of several researches on environmental hazards and genetic alterations, no     direct causes were found.      Patient suffering from glioma usually develops symptoms such as headaches, seizures, memory     loss and changes in behavior in its early phase. At later stages, patients may encounter loss     of movement and sensation, language dysfunction and cognitive impairments depending on     location and size of the tumor. The average survival of glioblastoma patients is 15 months     regardless of the use of multimodal therapy.      (Z)-BP/polymer wafer, designated as Cerebraca wafer, is a biodegradable wafer for     interstitial implantation comprises (Z)-n-butylidenephthalide ((Z)-BP; the active moiety) and     Carboxyphenoxypropane-Sebacic Acid Copolymer (CPPSA; the excipient).      Cerebraca wafer, the first human-use drug product, is a biodegradable implant comprises     (Z)-n-butylidenephthalide ((Z)-BP) and CPPSA. According to pre-clinical study, (Z)-BP could     reduce glioma migration and invasion, it also could reduce the tumor stem cell marker gens.   "
3918|NCT03234582|"     The primary objective of the study will be to compare intraoperative post TOF repair RVOT     gradient under two different anaesthetic depths. Secondary objectives will be to follow up     change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes     used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from     ICU and at 1 month follow- up   "
3990|NCT03233620|"     The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in     working-age patients (< 65 years) by conducting a prospective cohort study with 2-year follow     up. Outcomes were measured comprehensively using various patient-reported outcome measures     (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction,     physical activity, activities of daily living, and quality of life.   "
3921|NCT03234543|"     This phase II randomized (1:1) controlled trial will examine the effects of remote ischemic     conditioning (RIC) on the outcomes of major abdominal surgery. One hundred subjects will be     enrolled at a single institution - University Hospital - Newark. The study population are     patients undergoing major abdominal surgery (anticipated to be >/= 2 hrs long with a hospital     stay >/= 2 days). Subjects in the treatment group will receive lower limb ischemic     conditioning at 3 different time points: before surgery, POD 1 and POD 2. The primary outcome     is the 30-day comprehensive complications index (CCI). Key secondary outcomes are changes in     systemic inflammatory markers in peripheral blood and 30-day mortality.   "
3922|NCT03234530|"     This study focuses on the prevalence and identification of kidney disease among participants     of the WTC Health Program and the study team are planning to assess kidney disease in a     multi-factorial manner. The first aim of this study is to correlate kidney dysfunction with     9/11 exposure, and the study team predicts that exposure to 9/11 is an independent risk     factor in kidney disease among the WTC Health Program participants. Secondly, the study team     proposes that a well-established WTC-related condition, obstructive sleep apnea (OSA), is     independently associated with kidney disease. In addition, the study team believe there is a     temporal causative relationship between evidence of kidney disease and the severity of OSA.     Finally, the last aim is to further identify and explore potential mechanisms and phenotypes     of kidney disease in participants of the WTC Health Programs.      Regardless of whether the analyses support or reject these hypotheses, the findings will be     of equally great public health importance. Successful completion of the proposed research     would address a critical knowledge gap regarding the risk of kidney damage among this group     of patients, and would inform future mechanistic studies with the potential to impact     prevention.   "
3923|NCT03234517|"     Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis   "
3924|NCT03234504|"     This prospective study investigated the validity and test-retest reliability of stereopsis     test using head-mount display (HMD). Contour-based circles (crossed disparity: 1,960 to 195     arc of seconds(arc secs)) were generated as separate images on a high resolution phone     display (Galaxy S7; Samsung, Suwon, Korea) using a HMD (Galaxy Gear VR; Samsung, Suwon,     Korea). Two images were independently projected to each eye as graded circles with random dot     background. While the position of the stimulus changed from among 3 possible locations, the     subjects were instructed to select the circle with disparity by pressing the corresponding     position on a keypad. The results of the new HMD stereotest were compared to those from     standard Randot and TNO stereotests.   "
3925|NCT03234491|"     The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an     outpatient home study (Phase II). The two phase study design is chosen to enhance safety by     testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff     supervision before it could be investigated at the outpatient home setting. Phase II will not     begin without the establishment of safety in Phase I.   "
3926|NCT03234478|"     Every year, approximately 9,000 Parkinson disease (PD) patients undergo deep brain stimulator     (DBS) placement into the subthalamic nucleus (STN-DBS). Studies suggest that PD patients with     mutations in the glucocerebrosidase (GBA) gene are at high risk for cognitive impairment and     approximately 10-17% of subjects undergoing DBS carry GBA mutations. There may be an     interaction between STN-DBS, which also impairs cognitive function, and GBA, resulting in     worsened cognitive function. This project will 1) determine the relationship between GBA     mutation status and post-operative STN-DBS cognitive function, 2) broaden genotype-phenotype     relationships of GBA mutation carriers and 3) provide scientific knowledge regarding the     longitudinal cognitive effects of DBS in GBA mutation carriers through repeated     neuropsychological testing.   "
4040|NCT03232970|"     Comparison between two groups, experimental and control. Experimental will undergo lectures     on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done     before and after the 3-months long program. Comparisons will be made pre and post and with     groups.   "
3930|NCT03234426|"     Following stroke, patients loses functions of the motor, sensory and higher brain cognitive     faculties to various degrees which lead to diminished balance. It has been documented that     hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight     distribution, impaired weight-shifting ability and decreased stability capability. There are     many balance exercises and strategies; to improve balance in elderly age group population, to     prevent fall prevention. But we have very few evidences of giving manual perturbation balance     training in stroke patients to improve speed, balance and function. Therefore this study is     taken up to examine whether the manual perturbation balance training is more effective in     improving speed, balance and function in stroke patients.   "
3931|NCT03234413|"     Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental     spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of     Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the     two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.      With this study investigators would like to evaluate retrospectively if switching from one     toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin     to another was maintained.   "
3932|NCT03234400|"     Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio,     25 mg, 100 mg or 200 mg VRs.   "
3941|NCT03234283|"     A prospective, open label, non-randomized, single centre safety and feasibility study.     Patients with no expected airway difficulties scheduled for elective surgery including     tracheal intubation and general anesthesia procedures will be enrolled into the study.     Following standard induction of anesthesia, the IRRIS will be attached to the patient's neck     skin just beneath the laryngeal prominence (Adam's apple) and the intubation will be     performed by using a video-laryngoscope in a standardized fashion. The IRRIS device emits a     light that penetrates through the skin into the airway and that is visible on the     video-laryngoscope display. This light highlights the right pathway for the tracheal tube and     facilitates the visual recognition and identification of the laryngeal inlet. In case of     problems identified during the induction period such as an unexpected difficult intubation     situation and the IRRIS does not provide the expected facilitation of intubation, the local     unexpected difficult airway protocol goes into effect.   "
3933|NCT03234387|"     A great medical success is the increase in the median survival age associated with cystic     fibrosis (CF). However, this success has led to a new era of research with the aim to     maximise the quality of life (QoL) of the aging CF population. Recent research has     demonstrated that the traditional method of determining disease progression, i.e. pulmonary     function, no longer adequately predict survival rates. Therefore, various bodies have     promoted cardiopulmonary exercise testing (CPET), as outcomes from this test (e.g. one's     maximal O2 uptake [VO₂max]) are known predictors of the QoL, risk of hospitalisation and     prognosis of individuals with CF.      One of the most common non-pulmonary co-morbidities of CF is CF-related diabetes (CFRD).     Importantly, CFRD is associated with a poorer pulmonary function compared to CF patients     without CFRD, and ultimately a worsened prognosis. Despite this, the influence an impaired     glycaemic control has upon the VO₂max derived from a CPET is unknown in CF. Therefore, the     present study aims to assess whether VO₂max, an established determinant of QoL, differs     between patients with CF with and without established CFRD as well as a group of age- and     gender-matched healthy control subjects.      The additional measures within the present study, such as: biomarkers of inflammation, redox     balance and nitric oxide (NO2) bioavailability, as well as functional measures of     microvascular endothelial function will aid our knowledge of the physiological abnormalities     which are a cause or consequence of CFRD. Importantly, by identifying the factors which may     contribute to CFRD progression and those that are viable for early intervention, mean the     aims and objectives of this study are compatible with the top 10 research objectives set by     the CF Trust.   "
3934|NCT03234374|"     This is a multicenter randomized, single-blind, controlled study. The primary objectives of     this study are to obtain the pharmacokinetic profile and the relative bioavailability of the     INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.   "
3935|NCT03234361|"     An increasing number of studies have indicated that most fast food and common grocery items,     contain large amount of inorganic phosphate-based food additives , which are highly     absorbable. The long-term cardiovascular consequences of a high phosphate diet are unknown     but the existing database implicates phosphate excess as an independent risk factor for     cardiovascular events in individuals with and without chronic kidney diseases (CKD). High     phosphate consumption clearly induces BP elevation in rats with normal kidneys. However, the     mechanisms underlying phosphate-induced hypertension and the relevance of these rodent     studies to human hypertension have not been determined. We seek to investigate the role of     high phosphate diet in human hypertension and assess the effect of high phosphate diet on     muscle sympathetic nerve activity and the exercise pressor reflex.   "
3936|NCT03234348|"     This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter     clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be     followed for 5 years.      All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to        -  Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or        -  Biotronik ORSIRO Sirolimus Eluting Coronary Stent System      Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months     angiographic follow-up (Primary endpoint).      In a subgroup of 40 patients Optical Coherence Tomography will be performed after the     procedure and at 12 months follow-up.      Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months     follow-up) will be analyzed off-line by an independent core lab.   "
3937|NCT03234335|"     Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of     more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is     recommended when at least one of the myeloma defining events occurs (CRAB features). Renal     impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM     patients at diagnosis and 40-50% of patients during the course of their disease. To date,     there is no defined consensus for the management of myeloma patients with renal failure. It     is then of clinical importance to better considering available therapeutic options to improve     responses and survival of these patients.   "
3938|NCT03234322|"     Little evidence exists on the impact of diabetes risk scores, e.g. on physicians and     patient's behavior, perceived risk of persons, shared-decision making and particularly on     patient´s health. The aim of this study is to investigate the impact of a non-invasive     diabetes risk prediction model in the primary health care setting as component of routine     health checks on change in physical activity.   "
3939|NCT03234309|"     This phase II trial studies ferumoxytol in the magnetic resonance imaging of pediatric     patients with brain tumors. Magnetic resonance imaging using ferumoxytol may help in viewing     a brain tumor and blood vessels in and around the tumor in a different way than the standard     gadolinium-based contrast agent. Imaging with this experimental contrast agent may give     doctors more information about tumor blood supply and the extent of the tumor itself.   "
15567|NCT03081715|"     This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced     esophageal cancer. Blood samples will also be collected for research purposes.   "
3940|NCT03234296|"     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.     Appendicectomy, however, includes operative and postoperative risks despite being a routine     operation. At the same time other similar intra-abdominal infections, such as diverticulitis,     are treated with antibiotics. Several studies have proved promising results of the safety and     efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. Our previous     APPAC study, published in 2015 in the Journal of American Medical Association, also proved     promising results with 73% of patients with CT-diagnosed uncomplicated appendicitis treated     successfully with antibiotics within one-year follow-up. None of the patients initially     treated with antibiotics that later had appendectomy had major complications. The results of     the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical     emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary     appendectomies has also been shown to lead to significant economic savings.      Already in 1886 Fitz noted that 1/3 of patients in a large series of autopsies from the     pre-appendicectomy era had evidence of prior appendices inflammation suggesting spontaneous     resolution of acute appendicitis. Acute appendicitis is thought to be similar to acute     diverticulitis (left-sided appendicitis) and this similarity has been shown in     epidemiological studies. Recent studies have shown no benefit of antibiotic treatment in the     treatment of uncomplicated diverticulitis with outpatient management without antibiotics     proving safe and well-functioning.      The aim of this randomised double-blinded study is to compare antibiotic therapy with placebo     to evaluate the role of antibiotic therapy in the resolution of CT-diagnosed uncomplicated     acute appendicitis.      The hypothesis is that antibiotic therapy is necessary in the treatment of acute     uncomplicated appendicitis and that antibiotic therapy is superior to spontaneous resolution     (placebo) with the primary endpoint evaluated at ten days after the intervention.   "
3967|NCT03233932|"     A randomized, open-label, single dose, parallel design phase I clinical trial to investigate     the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after     subcutaneous injection in postmenopausal female.   "
3942|NCT03234270|"     The many complaints that have been expressed by the US aircrew of the F-35 regarding the heat     stress in the cockpit raised an obvious concern that, as a result of such heat levels, the     aviators' core body temperature may increase significantly, and subsequently cause severe     cognitive impairment- risking both the pilot and the mission.      In order to validate this hypothesis, we will measure the aviators' core body temperatures     while inside the cockpit of the F-35, to see whether their core body temperatures are rising     to a level that can cause heat stress or not. The temperatures will be measured on another     fourth generation aircraft as well for comparing purposes.      The temperatures will be measured using a Telemetric pill which will be ingested by each     aviator. Once ingested, the pill will transmit the data to an external monitor. The collected     data will be examined and analyzed in order to determine the likelihood of heat stress     occurrence.   "
3943|NCT03234257|"     Unstable plaques are characterized by lower segmental stiffness and intimal     neovascularization compared to stable plaques. Our objective is to determine the capacity of     the elastographic parameters obtained by the UF to discriminate the unstable to the stable     plaques. We hope to improve the stroke prediction in asymptomatic patients with carotid     stenosis.   "
3944|NCT03234244|"     Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study   "
3945|NCT03234231|"     Intellectual disabled persons faced more dental problems. According to a medical review paper     of international and local studies, this group has poorer dental hygiene, more severe gum     disease and more untreated caries. In 2010, a report from the guardians in Hong Kong     mentioned that most adults with intellectual disability cannot clean their teeth, the have     dental problems and it is very difficult for them to co-operate during the dental treatment.     In order to alleviate their dental problems, supervised toothbrushing programme and an oral     health education talk are proposed. We investigate the effectiveness of the supervised     toothbrushing programme and an oral health education talk. The target group of the study is     mild to moderate grade intellectual disabled students of special schools in Hong Kong. A     clustered randomised controlled trial design is adopted.   "
3946|NCT03234218|"     Interest in vitamin D has seen an unprecedented revival sparked by the finding that vitamin D     has pleiotropic effects with an intriguing link to the critically ill patients. The recent     VITdAL-ICU RCT found a significant difference in mortality in patients with severe deficiency     when high doses of vitamin D supplementation were administered.      Vitamin D deficiency is extremely common in patients with chronic liver disease and/or     cirrhosis. It seems to be a marker of severity of the disease, but also a possible     contributing factor in determining poor outcomes.      Design of the study: Observational prospective study. Primary variable end point: Vitamin D     at baseline, and POD (post-operative day) 1, 3, 7, 28.      Secondary variable end points: ICU length of stay; SAPS 2 and SOFA score at POD 1, 7; Days of     mechanical ventilation; Hospital length of stay; Mortality at POD 28; Diagnosed invasive     infections; Graft rejection in the first 28 days; Bilirubin and INR at POD 7 and 28.      SAFETY. The patient will not undergo to additional procedure during the study and will be     asked for consent to treatment of personal data.      SAMPLE SIZE. Because of the lack of knowledge in this specific cohort no formal sample was     calculated beforehand. The sample size will be defined by one-year clinical activity: about     60 consecutive patients.      STATISTICAL ANALYSIS. All statistical analysis and results will be assessed and reported as     exploratory analysis. In order to describe the trend over time of the vitamin D levels,     descriptive statistics such as mean, median, interquartile range and standard deviation will     be evaluated. In addition, 95% confidence intervals for mean and standard deviation will be     reported. Comparisons between two temporal observations will be assessed with paired t-test.     Any univariate association between factors or covariates, will be explored. Statistical     analyses will be done with SAS 9.4,   "
3954|NCT03234114|"     It is a prospective, multi-centered, randomized, controlled clinical trial (RCT) which     enrolled 930 acute coronary syndrome (ACS) patients concomitant persistent non-valvular     atrial fibrillation (NVAF) undergoing polymer-free drug eluting stent (DES) implantation in     China. All subjects will receive triple antithrombotic therapy (TT) including aspirin 100 mg     per day, clopidogrel 75 mg per day and warfarin with targeted INR 2-3 for 4 weeks or 6 months     in a randomized way after percutaneous coronary intervention (PCI) with stent. The baseline     characteristics of all patients and outcomes in 2 groups including composite endpoints of     all-cause death, non-fatal myocardial infarction, ischemic stroke, major bleeding (BARC     criteria ≥ 3a), and secondary endpoints including stent thrombosis (ST), target vessel     revascularization (TVR), re-hospitalization and minor bleeding will be collected and compared     during hospitalization and in 4weeks (± 7 days), 6 months (± 30 days) and 12 months (± 30     days) after PCI for office visits and in 2 weeks (± 7 days), 2 months (± 30 days) and 3     months (± 30 days) after PCI for phone call visits.   "
3947|NCT03234205|"     Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in     cardiac imagery. It has been initially used for quantitative evaluation of heart viability     and more recently for edema characterization. It allows to prematurely detect a cardiac     transplant rejection. This technique needs successively around ten FSE sequences during     apnea. Weak reproducibility of successive apneas and discomfort of patient limit the     precision of this measurement and consequently its use in standard care. The ARTEMIS study     method allows the examination during free respiration without prolonging the duration of     examination compared to the examination during apnea. Moreover, image processing is     simplified and correction of respiratory movements renders results more reliable.      This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is     a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows     to obtain diagnostic images without movement artifacts.      The primary objective si to show the feasibility of ARTEMIS method for measurement of     myocardial T2 relaxation time during free respiration in cardiac transplant patients.      The secondary objective is to collect quantitative data to compare ARTEMIS method of     measurement of T2 during free respiration and standard clinical practice during apnea.   "
3948|NCT03234192|"     The purpose of this study is to examine the effectiveness of three common techniques for the     treatment of lateral epicondylosis. Through objective and subjective assessments this study     will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment     Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis.     It is hypothesized that the more manual Astym technique and Graston technique will produce     more significant results than the more frequently utilized ultrasound.   "
4668|NCT03224754|"     According to the guidelines for reporting thyroid fine needle aspirations known as The     Bethesda System, the category of atypical cells known as AUS/ FLUS category has an estimated     rate of 5 to 15% for malignancy. This study aims to determine the rate of malignancy of this     category in our institution and to evaluate the clinical outcome of the participants.   "
3949|NCT03234179|"     Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence     rates of lung cancer among never smoking females in some parts of East Asia are among the     highest in the world. The adenocarcinoma of lung being the most frequently identified     histological type is more weakly associated with smoking, and often occurs in females and     never-smokers. Although family history of lung cancer has been associated with histological     subtypes, the inherited susceptibility factors that affect specific histology are unknown.      Genetic factors that determine individual predisposition to lung cancer have been identified     via genome-wide association studies. These known common loci, however, explain only a small     fraction of the familial risk of lung cancer. The hypothesis of this study is that there are     genetic factors that confer inherited susceptibility among patients with primary     non-small-cell lung cancer (NSCLC).   "
3950|NCT03234166|"     Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in     case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of     evolution. The step up approach is now widely recommended for the management of IPN. In fact,     in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first,     supported by probabilist antibiotherapy. 1/3 of patients won't require any other     interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was     formally realized by open laparotomy. Since de last decade, mini-invasive technics have     emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and     permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a     nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections     heterogeneity) which are negative predictors for success of catheter drainage in IPN with an     receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate     on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success.     Secondary aims are to evaluate possible others predictors for success of catheter drainage in     IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need     for an additional necrosectomy regarding its type and duration, as well as the emergence of     multiresistance organism.   "
3951|NCT03234153|"     The trial assess the safety and antitumor activity of the anti-PD-L1 antibody Durvalumab in     combination with the anti-CTLA4 antibody Tremelimumab.   "
3952|NCT03234140|"     Follicular lymphoma is the second most common adult B-cell lymphoma. The acquisition of the     t(14;18) translocation is the genetic hallmark of Follicular lymphoma. However, 50% to 70% of     healthy individuals harbor low levels of circulating t(14;18)-positive cells but will never     develop Follicular lymphoma. It was observed that individuals who developed Follicular     lymphoma showed a higher t(14;18) frequency than controls (Roulland et al., J Clin Oncol     2014). High t(14;18) frequency in blood from healthy individuals could be a predictive     biomarker for Follicular lymphoma development. Genetic instability of those t(14;18)+ B-cells     as well as failure of the micro-environment to control the proliferation of these cells are     proposed mechanisms linking these lymphoma precursors to true lymphoma cells. The prognosis     of Follicular lymphoma patients has been significantly improved mainly with the development     of anti-CD20 monoclonal antibodies, with a current median overall survival over 15 years.     However, this lymphoma remains an incurable disease. The most commonly used tool for     prognostication of patients with Follicular lymphoma is the Follicular Lymphoma International     Prognostic Index (FLIPI) based on conventional clinical and pathology parameters. Although it     has clinical utility, the Follicular Lymphoma International Prognostic Index does not reflect     the biologic heterogeneity of Follicular lymphoma. First-degree relatives of Follicular     lymphoma had a fourfold increased risk of Follicular lymphoma suggesting a genetic etiology.      Using the Genome wide association studies (GWAS) approach on Follicular lymphoma cohorts of     1,565 patients, the project plan to identify new prognostic markers. These markers will then     be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology,     using public or matched patient data. The investigators also plan to analyze the influence of     single-nucleotide polymorphisms on circulating t(14;18) levels in 318 healthy individuals     included in EPIC cohort that will develop Follicular lymphoma later on, and assess if these     biomarkers are helpful to refine the identification of high-risk Follicular lymphoma     individuals.   "
3953|NCT03234127|"     The main objective of SAFIR is to identify the atherosclerotic genetic factors in these     patients, which will identify new therapeutic targets for the treatment of CV and Familial     Hypercholesterolemia diseases. In addition, SAFIR will allow the identification of new CV     protection biomarkers, which will be useful tools for the development of a personalized     medicine for the management of dyslipidemias.   "
3963|NCT03233997|"     To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four     different marketed electronic cigarettes. Furthermore, to measure overall product liking by     subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in     the future.   "
3964|NCT03233984|"     Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major     foetal pathology and impact growth.      Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and     water.      Through a prevention program, the investigators tried to warned pregnant women on endocrine     disruptors exposition risks. The goal here is to assess the effectiveness of this program on     their fresh products consumption.   "
3955|NCT03234101|"     Public health policy is universal in recommending the adoption of low risk low-risk lifestyle     behaviors for health promotion and prevention of chronic or non-communicable diseases     (NCDs).These behaviors generally include achieving and maintaining a healthy body weight,     healthy diet, regular physical activity, smoking cessation, moderate alcohol intake, and     adequate sleep. While there is a general consensus that adherence to any one of these     low-risk lifestyle behaviors is associated with benefit, it is not clear if adherence to     multiple behaviors would result in a larger benefit across different groups of people,     conditions, and chronic disease outcomes. The Canadian Cardiovascular Society (CCS), as part     of the Dyslipidemia Guidelines Update, commissioned a series of systematic reviews and     meta-analyses (a type of knowledge synthesis) using the Grading of Recommendations     Assessment, Development, and Evaluation (GRADE) approach to quantify the benefit of adherence     to multiple low-risk lifestyle behaviors in relation to patient-important chronic disease     outcomes (risk of cardiovascular disease, diabetes, cancer, and death) and assesses the     quality and strength of the evidence for this benefit.   "
3968|NCT03233919|"     The primary objective of the CORIC-MI trial is to evaluate whether comprehensive (per, post     plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with     ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary     intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed     by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.   "
5286|NCT03216681|"     The purpose of this study is to evaluate the effectiveness of Hoat Huyet Nhat Nhat on the     reduction of common symptoms related to the insufficient blood supply to the brain such as     headache, vertigo, dizziness, sleep disorders and forgetfulness; compared with Gingko Biloba     Egb761 (Tanakan) after 45 days of treatment   "
3956|NCT03234088|"     As the population ages and medicine advances, there has been a significant shift to the     management of chronic diseases. Most chronic diseases are managed using evidence based     consensus guidelines but clinician and patient compliance with these guidelines is     sub-optimal. In addition, due to the nature of chronic diseases, patients need to make     long-term lifestyle changes in order to effectively control their disease in order to     minimize complications, disability and cost. It is these two factors, consistent     implementation of evidence-based guidelines and supporting patients in a way that encourages     self-management and lifestyle change, that disease management attempts to impact. There are     areas of design, implementation, testing and final-result-reporting to the patient and     clinician that require collaboration among information technology (IT) and software design     engineers and clinicians to achieve several goals:        1. Ensure patient safety.        2. Protect the security and integrity of clinical data.        3. Provide patient specific education to promote self-management.        4. Provide actionable data to clinicians in order to improve clinical care and minimize the          risk of adverse events.        5. Provide both patient and clinician satisfaction with the system of care.      In order to achieve these goals, testing and development of home technology under a     controlled clinical trial is critical.   "
3957|NCT03234075|"     Patients with terminal chronic kidney disease (CRD) need renal function supplementation,     namely dialysis or renal transplantation. Transplantation is the most efficient and     cost-effective treatment. Early and equitable access to transplantation is a public health     issue. Access to transplantation is facilitated by early and systematic information and     assessment of patients for inclusion in the national waiting list for transplantation prior     to the onset of dialysis, and by the development of transplantation from living donors. In     France, there are wide disparities in access to national waiting list registration and     transplantation. One of the causes of these inequalities in access would be the disparity in     referral practices to a transplant medical and surgical team authorized to register the     individual on the national waiting list.      The aim of the TRACE study is to evaluate the impact of a new regional organization promoting     renal transplantation on access to renal transplantation.   "
3958|NCT03234062|"     People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and     measurements of Cho pool size using isotope dilution should reflect this depletion.     Investigators will identify a biomarker panel that correlates well with measured Cho pool     size across the range of different degrees of depletion.The investigators propose that, as     body stores of Cho diminish, cells and organs will reach the point when metabolism/function     in the cell is altered, and that this will result in a progression of changes in biomarkers     that reflect Cho status.   "
3959|NCT03234049|"     The use of a pre-arrival and pre-departure trauma checklist to optimize care has not yet been     studied. The Alberta Children's Hospital (ACH) Trauma Checklist was developed by the ACH     Resuscitation Council with input from the ACH Trauma Program. The purpose of this study is to     determine if the introduction of the ACH Trauma Checklist as a cognitive aid, coupled with an     educational session, will improve clinical performance in a simulated environment. The     investigators plan to conduct a pilot, randomized control trial assessing the impact of the     ACH trauma checklist on time to critical interventions on a simulated pediatric patient by     multidisciplinary teams. The investigators hypothesize that teams who use a trauma checklist     as a cognitive aid will have faster initiation of key clinical interventions within a     simulated pediatric trauma resuscitation. Improvements in performance in a simulated     environment with this tool may translate to similar results in the clinical setting.   "
3960|NCT03234036|"     This study will be conducted in two Parts to confirm the acceptability/selection of a tablet     formulation for future clinical development of GSK2838232. Part 1 of the study will assess     single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing     approximately 30% fat) against the reference capsule formulation also given with food and     then will assess the impact of fasted conditions on the tablet performance. In Part 2,     non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate     group of subjects, assuming the tablet performance is considered acceptable from Part 1.     Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects     through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at     least 8 evaluable subjects through the single study period in Part 2. The maximum duration of     study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part     2.   "
3961|NCT03234023|"     DESIGN: Controlled clinical trial with single randomization, unmasked, open and unicentric.      CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored not supervised.     MAIN OBJECTIVE: To determine the incidence of major adverse cardiac events, MACE (total     mortality, new ACS, coronary revascularization, all-cause hospitalization) during the     one-year period after hospitalization for ACS.   "
3962|NCT03234010|"     To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four     different marketed electronic cigarettes. Furthermore, to measure overall product liking by     subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in     the future.   "
3965|NCT03233971|"     The aim of this study is to study patients' and caregivers' perspectives towards     deprescribing using the Revised Patients' Attitudes Towards Deprescribing (rPATD)     questionnaire.   "
3966|NCT03233958|"     The purpose of this study is to investigate the psychosocial effects of systemic / family     constellation. The method of systemic / family constellation refers to an approach which     integrates ideas from family systems therapy with elements from psychodrama. The     constellations are conducted in a group based seminar-setting, each seminar lasting two days.      Considering the very limited amount of empirical data on this method, the study design is a     simple pre-post one with a 6-months follow-up. The study will be observational: the     researchers will not manipulate who receives the intervention; instead they invite all     clients (individuals from the general population) attending these therapeutic workshops run     independently of the research process. Given the limited amount of evidence on this     therapeutic method, special attention will be given to monitor potential adverse outcomes to     establish intervention safety.      It is hypothesized that participation in a family constellation seminar might decrease     potential psychological symptoms and will not result in adverse outcomes.   "
21833|NCT02999815|"     To establish whether the addition of intrathecal tetanus antitoxin reduces the need for     mechanical ventilation in patients with tetanus   "
3969|NCT03233906|"     The purpose of the study is to examine the effect of chia seed consumption on body     composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary     displacement in overweight and obese females (18-45years). It is hypothesized that consuming     chia seeds will bring about a positive change in body composition (lower % body fat),     satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber     and improved nutrient intake, in overweight/ obese females.   "
3970|NCT03233893|"     sixty participants will be divided in to two groups (n=30) of patient treated by partial     caries removal according to the capping material (A),where (A1)represents calcium silicate     group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group     (A1) in deep occlusal caries and taking the base line image after restoring the cavity with     composite restoration and apply light activated calcium hydroxide for(A2)group in deep     occlusal caries and taking the base line image after restoring with composite     restoration.Take follow up image after one year to measure the calcific bridge formation for     both groups.   "
3971|NCT03233880|"     This randomized, double blinded controlled trial included 1200 healthy primigravidae who     attended an outpatient clinic at 16-20weeks of pregnancy. All women were randomly divided     equally into two groups, group A(600 women) who received antichlamydial treatment in the form     of azithromycin 1 gram single oral dose before 20 weeks of pregnancy and group B (600 women)     who received no treatment(placebo). All participants were followed up for up to 6 weeks     postpartum and observed for the development of preeclampsia.   "
3972|NCT03233867|"     This is a non-interventional study in children and adolescents (ages 6-17 years) with     attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in     glutamatergic signaling and neuronal connectivity. The screening in this study will be     conducted virtually through a central recruitment vendor.   "
3973|NCT03233854|"     This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T     cells when given together with chemotherapy, and to see how well they work in treating     patients with CD19 positive diffuse large B-cell lymphoma or B acute lymphoblastic leukemia     that has come back or does not respond to treatment. A CAR is a genetically-engineered     receptor made so that immune cells (T cells) can attack cancer cells by recognizing and     responding to the CD19/CD22 proteins. These proteins are commonly found on diffuse large     B-cell lymphoma and B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving CD19/CD22-CAR T cells and chemotherapy may work better in     treating patients with diffuse large B-cell lymphoma or B acute lymphoblastic leukemia.   "
3974|NCT03233841|"     The primary objective of this study is to establish the natural history of Farber disease     (acid ceramidase deficiency) through the collection and analysis of retrospective and     prospective data on patients diagnosed with Farber disease. All patients diagnosed with     Farber disease are eligible, including both those who have and have not undergone     hematopoietic stem cell transplantation (HSCT). Additionally, data and records from deceased     patients will provide valuable retrospective data for this study.      The secondary objective of the study is to establish a set of clinical data, laboratory data     (biomarkers), and functional data potentially useful for:        -  Assessing the efficacy of HSCT and the efficacy of of potential future therapies (for          example with RVT-801, recombinant human acid ceramidase) in Farber disease        -  Characterizing changes in symptoms of patients over time        -  Characterizing distinct groups (phenotypes) within the patient population        -  Documenting the disease histories of individual patients to serve as intra-subject          control data for those who may enroll in any future clinical studies with therapies for          Farber disease      The exploratory objectives of the study are:        -  To explore the relationship between patient disease activity or phenotype and specific          ceramide levels or specific immunologic markers (cytokines/chemokines) in blood        -  To evaluate a standardized tool, the Farber Disease Natural History Instrument (FDNI),          to be used for the collection of patient history information, data from clinical,          laboratory, genetic, and functional studies, and data from review of medical records   "
3984|NCT03233711|"     This randomized phase II clinical trial studies how well nivolumab after combined modality     therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal     antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and     spread.   "
4041|NCT03232957|"     This study evaluates postoperative numerical pain score and systemic opioid requirement     within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of     intrathecal morphine; 0,50, 100 ug with multimodal analgesia.   "
3975|NCT03233828|"     This study is meant to assess the use of intralesional IL-2 to modulate the immunological     response to suspected melanoma, or melanoma in situ, in an effort to increase lymphocyte     infiltration and decrease disease metastasis.      Patients that are clinically diagnosed with suspected Melanoma or Melanoma in situ will be     assigned to either a treatment or control arm. The treatment group will be subjected to two     intralesional IL-2 injections, whereas the control group will be subjected to two     intralesional injections of saline.      The proteomic and metabolomic profiles of both groups will be analyzed using urine and blood     samples in an effort to assess the systemic immunological response, if any, to the treatment.     Also, upon disease confirmation and staging by a qualified pathologist, lesions will be     assessed for lymphocyte infiltration using immunohistochemical methods.      This study will determine whether pre-treatment of IL-2 on lesions (clinically diagnosed as     melanoma or melanoma in situ) is effective in generating an adaptive immune response, and     whether that immune response may play a role in preventing disease metastasis.   "
3976|NCT03233815|"     This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor     necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to     asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled     anesthesia for this procedures.   "
3988|NCT03233646|"     This study aims to develop and evaluate biomarkers using non-invasive optical coherence     tomography angiography (OCTA) to assess the structure and function of the retinal     microvasculature in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD)   "
3977|NCT03233802|"     The object of this study is to develop a treatment for alcohol use disorders that is more     effective than current CB treatments. Through a 2009 R-21 pilot project the investigators     developed a cognitive-behavioral (CB) treatment that employed cellphone-based experience     sampling (ES) to collect detailed patient data, in near real-time, and that used those data     to direct treatment for each patient based on his/her pattern of drinking and specific coping     actions during high-risk situations. ES data included momentary assessments of situations,     thoughts and feelings antecedent to drinking episodes, and the use of coping skills. That     initial study of the Individualized Assessment and Treatment Program (IATP) showed promise.     The present study is intended to extend the earlier findings, to compare IATP to a more     active control treatment, and to evaluate long-term outcomes.   "
3978|NCT03233789|"     The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM     (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score     (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation     clinics.      The following steps are performed:        1. Development of an ADL-algorithms by experts        2. Validation of the ADL-algorithms in a quantitative approach        3. Finalization of the ADL-algorithms by experts based on study results   "
3979|NCT03233776|"     Oral and intestinal mucositis are major risk factors for the occurrence of fever during     neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These     complications often require dose reductions or cause delay of treatment, and thereby     interfere with optimal anticancer treatment. Currently, there are no effective strategies to     prevent or treat mucositis and the related complications.      The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown pivotal in the pathogenesis of     mucositis and recently, it has been established in murine models that IL-1 inhibition     significantly ameliorates chemotherapy-induced intestinal mucositis.      In this phase IIa study the safety, maximum tolerated dose and efficacy of anakinra, a     recombinant human IL-1 receptor antagonist, will be determined in adult patients with     multiple myeloma who receive high-dose melphalan (HDM) in the preparation for an autologous     hematopoietic stem cell transplantation (ASCT) and are at high risk for experiencing     mucositis and fever during neutropenia (FN). After establishing the optimal dose, a pivotal     double-blind randomized placebo-controlled multicenter phase IIb trial will be planned to     establish efficacy.   "
3980|NCT03233763|"     Ongoing laboratory work into the pathology of Leukaemia:   "
3981|NCT03233750|"     Previous research has shown that health professionals can experience stress responses during     high acuity events such as trauma resuscitations. These stress responses can lead to impaired     clinical performance. The goal of this proposed project is to adapt Stress Inoculation     Training (SIT) to the healthcare setting. Stress Inoculation Training is a     cognitive-behavioural approach to stress management that has proven effective in reducing     stress and improving performance in domains outside of healthcare.      Thirty-two emergency medicine residents will be randomly divided into two groups. The SIT     group will receive the simulation-based stress inoculation training. We will measure the     effectiveness of the training by looking at reduction of stress levels and improvements in     clinical performance in a pre-intervention and a post-intervention simulated trauma scenario.     The control group will be exposed to the same simulation scenarios and pre/post intervention     scenarios as the SIT group, but will not receive the stress inoculation training.   "
3982|NCT03233737|"     The purpose of this study is to determine if the topical application to gingival tissue of     the combination of benzocaine and tetracaine has a longer duration of local anesthetic     activity than benzocaine alone.   "
18109|NCT03048487|"     A retrospective study of protein intake and needs as well as outcomes in critically ill adult     patients. Data will be collected for up to 7 days of ICU stay.   "
3985|NCT03233685|"     Tennis is situational sport in which the result of the game is directly influenced by the     interaction with the opponent. In fact, athletes have to respond in a short-time period to     change the way of playing by fast analyzing speed, rotation and direction of the tennis ball.     Therefore, it is extremely complicated to predict exactly what will happen during games and     matches. According to literature goof visual skills, players can receive and process     information quickly and can optimize the performance with extreme precision and dexterity.     For this reason, visuomotor training aims to improve reaction times, but its efficiency     during playing tennis has not yet been investigated. Therefore, the aim of this study is to     investigate how this training method could affect the improvement of visuomotor performance     in young people between 12 and 18 years old.   "
3986|NCT03233672|"     To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for     prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP     or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate     bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was     prescribed based on NCCN risk categories. Median follow-up was 30 months.   "
3987|NCT03233659|"     Graft versus Host disease ( GVHD) is one of the major complications of Allogeneic Stem Cell     Transplantation. Acute GVHD develops early ( within 2to 3 months) after transplantation and     is the leading cause of death of transplanted patients. The pathogenesis of Chronic GVHD is     still little known. Chronic GVHD is caused by donor T lymphocytes, but we have no precise     knowledge on the participation of specific subsets of immune system cells to chronic GVHD. In     general, chronic GVHD is associated with an increase in the number of T effector lymphocytes,     both helper type 2 and cytotoxic.      Recently, also antigen presenting cells (APCs) have been implicated in pathogenesis of     chronic GVHD in studies performed on animal models. T lymphocyte responses that characterize     chronic GVHD require that recipient antigens are submitted by APCs which originate from the     donor's HSC ( Hematopoietic Stem Cells) APCs are heterogeneous population that includes     dendritic cells (DCs) ,monocytes, activated B lymphocytes and CD34+ cell subpopulations.     These cells can be identified by cytometry.      The data about APCs role in chronic GVHD are preliminary and often discordant. Seemingly,     there isn't correlation between circulating APCs number and risk of cGVHD. However, recent     data of our group show that patients with cGVHD could have higher number of monocytes in bone     marrow than transplanted patients without cGVHD.      The aim of study is to measure the number of circulating immune cells in the PB (peripherical     blood) before and after Allogeneic Hematopoietic Stem Cell Transplantation by flow cytometry.   "
3991|NCT03233607|"     This is a prospective cohort study of patients delivering at Columbia University Medical     Center/ Allen Hospital. For the primary research question, the investigators will compare the     change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation     with estimation of blood loss (EBL) and quantitative blood loss (QBL). The investigators will     also simultaneously conduct noninvasive hemoglobin spot checks at the time of each routine     phlebotomy for hemoglobin assessments at three time points (admission, postpartum day 1 and     postpartum day 2) to determine the accuracy of the Pronto co-oximeter to detect any     significant changes maternal hemoglobin levels.   "
3992|NCT03233594|"     Central nervous system (CNS) changes associated with pain have been difficult to measure     until the development of functional neuroimaging techniques such as positron emission     tomography (PET). We have previously observed asymmetry in the thalamus associated with     chronic pain that altered during acupuncture therapy. Imaging studies of therapeutic     techniques for chronic pain in animals and humans have been quite limited. This study will be     the first to utilize FDG PET-MRI imaging of both the brain and body in order to assess CNS     changes and peripheral body changes related to chronic pain and its potential management.   "
3993|NCT03233581|"     The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the     Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the     Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39     years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer     influences will be engaged via a private, social network (e.g. a Facebook group) customized     for survivors. Measurements will be completed (1) at baseline, prior to randomization, and     (2) during the final week of the intervention period (follow-up measure). This pilot study     will provide initial proof of concept and allow for further customization of the intervention     for cancer survivors in anticipation of a future, larger proposal to study physical activity     and related outcomes over a multi-year period.      Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT,     we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39     years and between 1.0-5.0 years from the completion of active cancer therapy, (2)     intervention participants wear the Fitbit Flex on the majority of all intervention days     during the 12-week intervention period, and (3) ≥75% of all participants complete online     questionnaire data collection at Time 1 and Time 2.   "
4101|NCT03232177|"     This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks     and duration of administration for 1 year in patients with high-risk essential     thrombocythemia.   "
3994|NCT03233568|"     The investigators will retrospectively analyze and compare data of 2 groups of overweight and     obese patients: subjects who followed a diet based on Resting Energy Expenditure (REE)     measured by indirect calorimetry and subjects who followed a diet based on REE estimated by     the Harris-Benedict equation. Propensity score adjustment will be used to adjust for known     differences between the 2 groups   "
3995|NCT03233555|"     This study tests four different methods of educating patients about follow-up care (NCI     facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS     website & health coaching combination) after cancer treatment ends. While it is known that     patients need information to guide follow-up it remains unknown how to best provide this in     primary care.   "
3996|NCT03233542|"     The aim of the study is to examine panic-related associations and interpretations in the     context of Panic Disorder and its treatment. While theoretical accounts of Panic Disorder     suggest a central role of such associations and interpretations in the onset and maintenance     of the disorder, research to date in fact leaves many questions about the nature of these     dysfunctional cognitions and their potential role unanswered. Patients with Panic Disorder     and a control group of patients with other anxiety disorders will complete measures of     panic-relevant associations and interpretation bias. The patients with Panic Disorder will be     randomized to receive either Cognitive Behaviour Therapy (CBT) or a waiting list condition     (to be followed by CBT after completion of the study procedures). The anxious control group     will also receive CBT. Panic-relevant associations and interpretations will be measured     twice, i.e., pre and post CBT/waitlist. Furthermore, relevant symptom measures and     physiological and biological markers will be assessed and responses to a hyperventilation     challenge. The study aims to further advance our understanding of cognitions in the etiology     and maintenance of Panic Disorder, and inform future treatment optimisation.   "
3997|NCT03233529|"     This study is being conducted to characterize the mechanism of action of crisaborole ointment     2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD)     lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate     AD. Two identified AD skin lesions for each subject will be treated for the first 15 days,     one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for     biomarker analysis will be performed on the lesions. Following completion of the blinded     treatment period, subjects will start the 28 day open label period during which all AD     affected skin lesions will be treated with crisaborole ointment 2% twice daily.   "
3998|NCT03233516|"     The overall aim of the TREND study is to improve the differential diagnosis of bacterial and     viral etiology in children below 5 years of age with clinical community acquired pneumonia.      Specific objectives:        -  To assess the diagnostic accuracy of MxA for viral CAP (sub-study I)        -  To study etiologies in children with CAP (sub-study II)        -  To evaluate sensitivity and specificity for MariPOC® Respi test versus PCR for detection          of respiratory viruses (sub-study III)        -  To assess sensitivity and specificity for a novel RPA-based point-of-care test versus          PCR for detection of respiratory viruses (sub-study IV)        -  To assess long-term complications in children with CAP (sub-study V      The study takes place at Sachs' Children and Youth hospital in Stockholm.   "
4013|NCT03233321|"     The study evaluate the effectiveness of dry cold application on pain intensity and bruise at     the subcutaneous injection site among patients admitted in medical I.C.U. Purposive sampling     technique was used to select 60 hospitalized patients (30 in experimental and 30 in     comparison group). Dry cold was applied to the subcutaneous injection site using ice bag     filled with crushed ice with half table spoon of salt for 20 minutes after the administration     of injection and no intervention was given in comparison group.   "
4014|NCT03233308|"     To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02%     compared to placebo   "
3999|NCT03233503|"     Food is selected primarily on their taste and texture properties. It is essential to get more     insight in taste and texture characteristics of the foods in the Dutch and Malaysian diets     for a better understanding of food choices. Currently, there is insufficient information on     taste and texture properties of foods to relate these properties to the composition of diets     and individual food choice in larger (observational) studies.      In the current study, the investigators want to assess the perceived intensities of the 5     basic tastes, i.e. sweet, salt, sour, bitter and umami, as well as fat sensation and texture,     in an array of about 1,000 often consumed Dutch and Malaysian foods. The investigators aim to     do this with a trained sensory panel, which is a well-accepted way of assessing perception of     sensory attributes.      With the current study, the investigators aim to build a table, which is comparable to the     food composition table, but contains data that describes foods and meals in terms of sensory     properties. That is, investigators want to quantify sensory characteristics of about 1,000     commonly eaten Dutch and Malaysian foods. This enables investigators to add sensory     information to the food intake data that is already being collected in observational studies,     and to further understand food choices in specific populations, such as elderly and patient     groups. In current project, the investigators also aim to compare the Dutch diet to the     Malaysian diet in term of sensory properties.   "
4000|NCT03233490|"     The overall aim of this thesis is to identify the factors that may affect 13 year old     students' acquisition of CPR skills and their willingness to act. The primary hypothesis is     that the training method (intervention) influences the participants' acquisition of practical     CPR skills and willingness to intervene.      The study used a cluster randomized design, based on a randomization list generated by an     independent statistician. The school classes were randomly assigned to different CPR training     interventions.      A strategic sample, where invitation to participate in the study was sent to the headmasters     of all council schools, with seventh grade students, in two Swedish municipalities (140,000).     Thus, the sample consists of participants with different cultural as well as socio-economic     background. Eighteen of 24 schools agreed to participate. Four schools did not respond and     two schools had a routine to offer CPR education only for grade nine (all six schools from     the same municipality). The eighteen schools who agreed to participate consisted of     sixty-eight classes with 1547 students.      Prior to study participation, students and their guardians obtained a letter with study     information. Study participation of the individual students was voluntary and all     participants gave an oral informed consent.      Inclusion criteria: seventh grade student in one of the participating schools. Exclusion     criteria: student does not want to participate, student with a physical handicap that limited     the physical performance, classes of students with development disabilities (these classes     are age-integrated and have fewer students per class).   "
4022|NCT03233204|"     This phase II trial studies how well olaparib works in treating patients with solid tumors,     non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA)     damage repair genes that have spread to other places in the body and have come back or do not     respond to treatment. Olaparib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
4001|NCT03233477|"     Posner-Schlossman syndrome, or glaucomatocyclitic crisis, is a condition characterized by     recurrent, acute attacks of mild, nongranulomatous, anterior uveitis accompanied by markedly     elevated intraocular pressure. Most of patients are the 20 to 50-year-old young adults, with     unilateral eye involvement. PSS was originally deemed benign, but is now recognized as a     relatively rare cause of chronic secondary glaucoma,especially in patients with recurrent     episodes. This relatively rare disease is likely the result of the infections of a variety of     organisms, and the bulk of literature supports the cytomegalovirus (CMV) as the leading     cause.      This study is an observational study that does not interfere with the normal clinical     diagnosis and treatment process. The investigators in this study focus on observing the     clinical symptoms and outcome of PSS, analyzing the factors that affect the prognosis of PSS,     studying the association of its pathogenesis with the psychological status and the behavioral     types of PSS patients; exploring the relationship between infection (CMV, HSV, Hp) and PSS;     and studying the changes of local and systemic cytokine expression and its significance in     patients with PSS.   "
4002|NCT03233464|"     - One single operator will assess the prevalence of molar incisor hypomineralization and its     Severity among a group of Egyptian children in Giza Governorate .   "
4003|NCT03233451|"     The study aims to explore the effectiveness of psycho-behavioral intervention on depressive     symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac     function and quality of life will also be explored.   "
4004|NCT03233438|"     The purpose of this study is to assess the effect of a new critical pathway (use of     guideline-based patient identification criteria and for those who meet these criteria, use of     dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin     Structure Infections)   "
4005|NCT03233425|"     The aim of this pilot project is to disseminate multiprofessional group programs (*MGP*) for     therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based     behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and     family behaviours, after the intensive phase (*T1*), at 1 and 2 years after start (*T2*,     *T3*). MGP costs are reimbursed in Switzerland: 1) if 116 sessions are provided by experts in     physical activity, nutrition and psychology; 2) if parents are included and if their     adherence is higher than 85%. In the nationwide Evaluation of Multiprofessional Group     Programs for Paediatric Obesity Therapy (*KIDSSTEP*) study, multiple psychosocial and     physical parameters were assessed at T0, T2 and T3 . Out of 33 certified centers, 25 were     active and only 19 were re-certified in 2013/2014. Obese children suffer from major     co-morbidities and therefore, only one third of referred patients can be treated in MGPs and     their beneficial effects on obesity as well as physical and mental health outcomes are     sustained over 2 years.   "
4015|NCT03233295|"     A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin     D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency   "
4681|NCT03224585|"     The goal of this study is to determine the safety and efficacy of anakinra for the treatment     of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7     days.        1. to determine the efficacy of anakinra with respect to chest pain resolution        2. to determine the safety of anakinra with respect to adverse drug events   "
4006|NCT03233412|"     Cervical cancer is one of the leading malignancies affecting women, with 266,000 deaths in     2012, most of them seen in underdeveloped countries. This neoplasm has a pre-invasive state,     such as cervical intraepithelial neoplasia (CIN), which is caused by HPV (Human     Papillomavirus) infection. The female organism most often is able to eliminate the virus,     especially in young patients. However, when the infection becomes persistent, especially for     subtypes 16 and 18, the risk of CIN developing an increased. Cytological screening programs     can efficiently and wirelessly do this. As high-grade intraepithelial lesions (CIN 2/3) are     as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for     progression to invasive cancer. As CIN 2/3 need treatment, and as more therapies as they are     excisional, which theoretically are better, however, they may compromise the reproductive     future of women who are unthreatened, increasing the risk of preterm labor, premature rupture     of amniotic membranes, low weight Birth and perinatal mortality. This relationship aroused     interest in seeking alternative therapies. Decrease antiviral activity directed against HPV,     associated with a higher rate of elimination of the infection. Immediate, an agent that     stimulates like dendritic cells to producer cytokines and activates epithelial T cells.     Imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting     satisfactory results without treatment of CIN 2/3 of the uterine cervix, requiring a better     scientific compilation. Based on these data, this study aims to evaluate the efficacy of     topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.   "
4007|NCT03233399|"     The purpose of this protocol is to learn about movement intention and volition. To improve     such knowledge, investigators will conduct sub-studies using multiple non-invasive     methodologies. These results could provide preliminary data for subsequent studies evaluating     local and global efficacy of plasticity-inducing treatments for PMD symptoms.   "
4008|NCT03233386|"     Sharp increases in substance use rates among youth in Mexico are a major concern, both in     Mexico and the US. Although the Mexican government has elevated substance abuse prevention as     a national priority, there are few school-based universal prevention programs to choose from     that are culturally grounded, empirically tested, and shown to be efficacious. This study     aims to address this gap by adapting, implementing, and testing the keepin' it REAL (kiR)     prevention intervention in Mexico's three largest cities: Mexico City, Guadalajara, and     Monterrey. kiR is a model program for middle school students on the US National Registry of     Effective Programs and Practices, shown to be efficacious and cost-effective in reducing     substance use among large multi-ethnic and Mexican American samples in the US. The proposed     study will leverage the bi-national research team's expertise in developing and adapting kiR     and build upon a series of feasibility studies across Mexico which showed that kiR's core     elements are applicable there. However, evidence also suggested that further adaptation is     needed to enhance the intervention's cultural fit. During the proposed study's Phase 1,     students and teacher-implementers in three schools—one from each of the cities—will provide     feedback about the original curriculum and identify culturally and contextually relevant     scenarios and examples. The bi-national research team—including original kiR curriculum     designers—will collaborate to ensure cultural applicability in Mexico and fidelity to core     elements of kiR. In Phase 2, the efficacy of the culturally adapted Mexican version of kiR,     relative to the original version of kiR and to a control condition, will be tested through an     intent-to-treat analysis in a randomized controlled trial with 7,768 7th grade students in 36     middle schools, 12 from each city. The study will investigate and incorporate into the     curriculum gender specific experiences with drug offers and appropriate drug resistance     strategies in the Mexican context that may impact the youths' risk of substance use and their     responsiveness to prevention programs. In light of rising violence in Mexico, a secondary aim     of the study is to investigate how youths' perpetration, victimization, and witnessing of     violence may moderate the efficacy of kiR in Mexico. The study will create knowledge relevant     to efficacious prevention approaches for Mexican-heritage youth on both sides of the     US-Mexico border. Prevention science will be advanced by understanding how culturally     influenced gender norms affect substance use offers, attitudes, and behaviors, as well as the     success of universal prevention programs. In addition, the study will add to knowledge on how     to execute collaborative, cross-national, translational prevention intervention research.   "
4023|NCT03233191|"     This randomized phase III trial studies digital tomosynthesis mammography and digital     mammography in screening patients for breast cancer. Screening for breast cancer with     tomosynthesis mammography may be superior to digital mammography for breast cancer screening     and may help reduce the need for additional imaging or treatment.   "
4009|NCT03233373|"     Currently, there are no tools that can measure nasal airflow in an objective manner that is     non-invasive to the patient. This clinical study aims to address this by evaluating the use     of thermal imaging as a diagnostic tool for measuring nasal airflow.      Proper airflow cools the nasal airway as it passes--obstructions or narrowed airways hinder     flow and results in elevated temperatures along the airway and nasal tissue. It is this     elevation in temperature, or more specifically, loss of cooling, that we hypothesize to be     measurable with thermal imaging. Participants in this study will be asked to perform 3-4     nasal breathing cycles which will be recorded by the thermal imager.   "
4010|NCT03233360|"     This registry is designed as a multi-centre longitudinal cohort study of patients diagnosed     with HCC between 1st January 2013 and 30th June 2018 in nine countries (ie, Korea, Taiwan,     Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30%     of the sample size will be identified retrospectively and 70% will be identified     prospectively from the start date of the registry (October 2016), with an even distribution     of consecutively diagnosed patients within the different years.   "
4011|NCT03233347|"     This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine,     dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients     with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin     hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with     the ability of cancer cells to grow and spread by enhancing the immune system. Giving     doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may     improve survival of patients with stage I-II Hodgkin lymphoma.   "
4012|NCT03233334|"     The Purpose Project intervention is an 8-session progressive structure that was developed     based on theoretical and scientific evidence from psychology and occupational therapy. The     goal of the intervention is to provide participants with information, tools, and support that     help them move towards reclaiming a sense of self-grounded purpose in daily life. The study     will use a convenience sample of women with breast cancer to evaluate the feasibility of the     Purpose Project intervention in terms of demand/acceptability, implementation, and     limited-efficacy testing. Findings will be used to inform a later study to evaluate the     efficacy of the Purpose Project intervention.   "
4682|NCT03224572|"     This study determines whether high dose vitamin C is effective for quality of life in     terminal cancer patients.   "
4683|NCT03224559|"     This study seeks to understand at how noninvasive electrical brain stimulation might change     how people perform on on tasks requiring concentration and thinking skills.   "
4016|NCT03233282|"     Identify, characterize and then validate electrophysiological markers linking     electrophysiological cerebral activity and performance in cognitive and physical fatigability     in humans. To do this, noninvasive explorations of electroencephalography (EEG) and     magnetoencephalography (MEG) will be carried out under two conditions of different     experiments, the first one that induces a cognitive fatigability and the second one that     induces physical fatigability.   "
4017|NCT03233269|"     The purpose of this study is to investigate the effects of the BEATS music therapy program on     the self-efficacy, trust, knowledge, and adherence of young adult patients with SCD.      Primary Hypotheses:      Compared to baseline, young adult patients with SCD who receive the music therapy     interventions will report:      Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES),     Higher trust in health care providers as measured by the Wake Forest Trust in the Medical     Profession Scale, and Higher SCD knowledge as measured by the Seidman Sickle Cell Knowledge     Quiz.      Secondary Hypotheses Compared to the one year prior to the study period, young adults with     SCD who receive the music therapy interventions will have a higher rate of adherence to     clinic appointments during the one-year study period.      Additional Questions Do music therapy interventions influence the rate of hospital     utilization as measured by ED visits, Acute Care Clinic (ACC) visits, and admissions during     the study period compared to the previous year? Do music therapy interventions influence     adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in     mean corpuscular volume (MCV) during the study period? Do music therapy interventions     influence adherence to iron chelation therapy for patients receiving iron chelation therapy     as measured by ferritin count during the study period? Does the schedule of music therapy     interventions in this study improve outcomes more significantly than the schedule of music     therapy interventions from [IRB# 03-15-30]?   "
4018|NCT03233256|"     This study proposes to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva     and breath by comparing the natural abundances of 2H:1H and 18O:16O in saliva and urine of     un-dosed humans.   "
4019|NCT03233243|"     Atherosclerotic plaque uptake of 18F-sodium fluoride (NaF) in positron emission tomography     with computed tomography (PET-CT) was recently shown to correlate with clinical instability     in patients with CV disease. The investigators hypothesize that rosuvastatin reduces 18F-NaF     plaque uptake.      The investigators will scan coronary, aortic and carotideal arteries of high-risk CV subjects     with 18F- NaF-PET-CT. Individuals with 18F-NaF-positive plaques will be treated with     rosuvastatin for six months, followed by 18F-NaF-PET-CT re-evaluation.   "
4020|NCT03233230|"     The purpose of the study is to determine the efficacy, dose response, and safety of     evobrutinib in subjects with Rheumatoid Arthritis (RA), and to consider a dose to take     forward into Phase III development.   "
4021|NCT03233217|"     This phase I/II, randomized, modified double-blind, multi-center study will assess the safety     and immunogenicity of a high-dose quadrivalent influenza vaccine (QIV-HD) in older adults     (≥65 years).   "
16263|NCT03072602|"     The purpose of the study is to discover any racial dissimilarity in the response of     Natriuretic peptide (NP) system to acute metabolic influences such as a high carbohydrate     challenge   "
4024|NCT03233178|"     The primary objective of this study is to investigate the change in Alanine Aminotransaminase     (ALT) in patients with Type 2 Diabetes Mellitus (T2DM) initiating Sodium Glucose     Cotransporter 2 (SGLT2) inhibitors, liraglutide, or sitagliptin, compared to a control group     of patients who did not initiate a new antihyperglycemic therapy. The hypothesis is that     patients using Sodium Glucose Cotransporter 2 inhibitors (SGLT2i) will achieve a greater     reduction in ALT compared to the control group.   "
4025|NCT03233165|"     Oral leukoplakia is a precancerous lesion with relatively high malignant transformation     potential. They are often treated by wide surgical excisions or conservative retinoids     therapy. The use of high power ablative lasers has been proposed as an effective way of     treating these lesions safely. The aim of this study was to evaluate efficiency Er:YAG and     Er,Cr:YSGG laser, in the treatment of oral leukoplakia.   "
4026|NCT03233152|"     Phase I clinical trial on intra-tumoral ipilimumab plus intravenous nivolumab following the     resection of recurrent glioblastoma.      The aim of this clinical trial is to exploit the potential synergy of combined intra-tumoral     CTLA-4 and systemic PD-1 blockade while minimizing the risk for increased immune-related     toxicity by intratumoral administration of the CTLA-blocking mAb ipilimumab following the     resection of the recurrent glioblastoma.   "
4027|NCT03233139|"     The primary objective of the study is to assess the safety, tolerability, and PK of REGN2810     as monotherapy in Japanese patients with advanced malignancies. The secondary objective of     the study is to assess the immunogenicity of REGN2810.   "
4028|NCT03233126|"     The purpose of the study is to assess the efficacy and safety of KRN23 administered     subcutaneously once every 2 weeks in children with X-linked hypophosphatemic     rickets/osteomalacia(XLH)   "
4029|NCT03233113|"     Exposure-based cognitive-behavioral therapy (i.e., exposure therapy), which entails     repeated and prolonged confrontation with feared situations/stimuli, is the most effective     treatment for anxiety disorders (e.g., arachnophobia). Safety behaviors are actions performed     to prevent, minimize, or escape a feared catastrophe and/or associated distress (e.g.,     wearing thick shoes or gloves when around areas where there might be spiders). It is     understood that safety behaviors contribute to the development and maintenance of anxiety     disorders; accordingly, patients' safety behaviors are traditionally eliminated as soon as     possible during exposure therapy (i.e., response prevention). Unfortunately, not everyone     who receives exposure therapy benefits from this approach. To address the limitations of     exposure's effectiveness, some experts have questioned the clinical convention of response     prevention during exposure therapy. Specifically, they propose the judicious use of safety     behaviors: the careful and strategic incorporation of safety behaviors during exposure     therapy. The controversial role of permitting safety behaviors during exposure has garnered     substantial research attention, yet study findings are mixed. The current study, therefore,     was designed to improve upon the methodological limitations of previous related research and     examine the relative efficacy of traditional exposure with response prevention (E/RP) and the     experimental exposure with the judicious use of safety behaviors (E/JU) in a sample of adults     with arachnophobia. In light of previous related research, several hypotheses were made     regarding the short- (posttreatment) and long-term (1-month follow-up) treatment effects:        1. Primary outcomes: E/RP participants will demonstrate greater improvement in spider          phobia than the E/JU participants along behavioral and self-report symptom measures at          follow-up.        2. Secondary outcomes: Treatment acceptability and tolerability will be higher for E/JU          participants, relative to E/RP participants, before beginning exposures and at          posttreatment, but not at follow-up. In addition, hypothesize that E/RP participants          will report greater reductions in peak distress and greater improvements in distress          tolerance relative to E/JU participants at follow-up.        3. Additional outcome: Exploratory analyses will be conducted to compare the relative rate          of behavioral approach and exposure goal completion between treatment conditions.   "
4030|NCT03233100|"     Constipated patients often have mental problems such as depression and anxiety due to     difficult defecation. Our previous studies have proved the efficacy of FMT treating     constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota.     This trial is based on the theory of the gut-brain-microbiota axis. Patients with     constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota     examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the     potential role of gut microbiome in these gut-brain disorders.   "
4031|NCT03233087|"     The registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic     aneurysm/aortic dissection.   "
4032|NCT03233074|"     It is of clinical significance to better characterize the intrinsic defects harbored by     mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia     (AML) context, as compared to physiological conditions. Such research initiative aims to     dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow     (BM) partners in crime, further prospecting for innovative stromal-directed strategies for     the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).   "
4033|NCT03233061|"     Many obese individuals experience difficulties in executing household activities. In this     study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and     the impact of obesity on cardiorespiratory functioning during daily household activities.   "
4034|NCT03233048|"     The reason we are doing this research is to get information about the ORBERA™ Intragastric     Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are     overweight will lose weight and if their other medical problems will get better. ORBERA™ is a     special balloon approved by the FDA for overweight adults, and we would like to try using it     for overweight teenagers.   "
4035|NCT03233035|"     To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine     analgesic agents in patients with moderate to severe pain in the ED in reducing the need for     opioid or class III analgesic agents.   "
4037|NCT03233009|"     To assess the irritation potential of four prototype daily defense serum formulations after     24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.   "
4038|NCT03232996|"     Examining the feasibility and acceptability of the computer game based rehabilitation system     for improving balance, gait and executive function in individuals with PD. This will involve     a pilot case series intervention study of individuals with PD will be conducted.   "
4039|NCT03232983|"     This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood     sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh     and arm.      The study will be conducted in healthy people to investigate the effect of different     injection sites on the amount of insulin lispro in the bloodstream.      Side effects and tolerability will be documented. The study will last for about 10 weeks for     each participant, including screening and follow up. Screening is required within 28 days     prior to entering the study.   "
4042|NCT03232944|"     The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to     improve CRT response in the non-responder patient population when used in real-world     clinical practice, following commercial release. This evaluation is based on the Clinical     Composite Score which summarizes the proportions and frequencies of CRT non-responder     patients who are improved, unchanged or worsened after receiving MPP therapy. Patients     will be followed for the duration of the PAS. This study is required by FDA as a condition of     approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).   "
4043|NCT03232931|"     Every year, almost all of ½ million infants born prematurely in the US and 15 million     worldwide suffer from abnormal brain maturation resulting from interactions between     immaturity and atypical sensory experiences after birth. The current proposal uses rigorous     scientific methods to measure the effects and determine the mechanisms of action of a     parent-supported multisensory neurorehabilitative intervention for preterm infants, adaptable     to a wide variety of neonatal environments, even when parents cannot be at their child's     bedside. The intervention aims to improve brain multisensory processing, reactions to sensory     stimulation in the home and long term language and motor development.   "
4044|NCT03232918|"     The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%.     This variability may be due to fluid and oxytocin management prior to and during the     initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin     infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a     reduction in the incidence of adverse fetal heart rate changes.   "
4045|NCT03232905|"     This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of     inflammatory bowel disease. The goal of the study is to assess the safety, tolerability,     pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600     in Japanese healthy volunteers.   "
4046|NCT03232892|"     Phase II trial to evaluate trametinib in patients with locally advanced non-squamous,     non-small cell lung cancer (NSCLC) whose tumors harbor a non-synonymous NF-1 mutation, with     progressive disease on at least one prior line of chemotherapy including a platinum doublet.   "
4047|NCT03232879|"     The main objective of this study was to compare the activation of the Sympathetic Nervous     System in a program that combined Motor Imagery with Action Observation, in contrast to an     isolated Motor Imagery program both, in asymptomatic subjects, and in patients with chronic     low back pain.   "
4059|NCT03232723|"     The primary purpose of this study is to determine the effectiveness of the     Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body     other than the brain. This study will examine if electrical activity from parts of the body,     other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies     of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which     can be severe, yet there is no non-invasive way to image this abnormal activity. This is     particularly relevant to deep muscle pain and back pain.   "
5287|NCT03216668|"     The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST     in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after     6 weeks of treatment.   "
4048|NCT03232866|"     There has been an increasing awareness about the need to practice some physical activity,     including several objectives, mainly as a preventive character. From this perspective, notice     the use of the Pilates method as an instrument of therapeutic exercise for the protection and     promotion of health. However, despite being popularly performed, there is still no scientific     evidence on the standardization of the use of the method and its progression to an adequate     prescription of physical training. The objective is monitoring the progression of loads of a     12-week training among the basic, intermediate and advanced levels of the Pilates method     through heart rate (HR), subjective exertion perception (PSE) and heart rate variability     (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic     parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the     initial assessment and familiarization with the method, the training period will begin     totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During     the three months, the participants must pass through the three levels of training: Basic,     Intermediate and Advanced. During each session, the investigators will initially collect:     psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory     parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen     saturation). Throughout the session a heart rate meter will be positioned on the chest of the     participant to capture HR, which will occur every five minutes together with the PSE     illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory     parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be     analyzed at baseline and after three months of training. In the case of HRV analysis, linear     methods in the time and frequency domain will be verified. For the statistical analysis of     the cardiorespiratory and autonomic parameters in the pre and post training moments will be     used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of     the training load will be used the correlation of Pearson or Sperman according to normality.     The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC     curve.   "
4049|NCT03232853|"     The purpose of this observational study is to assess the efficiency of an e-learning in order     to put into practice some preventive measures to avoid medication errors during anesthesia.   "
4050|NCT03232840|"     The purpose of this observational study is to assess the efficiency of an e-learning in order     to put into practice some preventive measures to avoid wrong site surgery during anesthesia.   "
4051|NCT03232827|"     The overall aim of the current study is to determine if flavorings contribute to the     initiation and maintenance of waterpipe (WP) smoking and also influence how a WP is smoked,     which has implications for both risk of dependence but also smokers' level of exposure to     tobacco-related toxicants. Using a randomized crossover-design, 76 current WP smokers (38 low     dependent, 38 high dependent) will complete three counterbalanced WP smoking sessions     (preferred flavored-sweetened, unflavored-sweetened, and unflavored-very low sweetened) that     are preceded by 12 hours of tobacco/nicotine abstinence. Sessions will be separated by a     standard 48-hour washout period.   "
4052|NCT03232814|"     In Canada, over 102,900 men are diagnosed with cancer each year. Of these, 81,000 are     diagnosed with colorectal cancer and an estimated 65% are expected to survive the disease for     at least 5 years. Men who have completed treatment for colorectal cancer face many adverse     physical, cognitive, psychological, and social effects. The Wellness Beyond Cancer Program at     The Ottawa Hospital is a cancer survivorship program that helps people who have completed     treatment for cancer, including men diagnosed with colorectal cancer, manage these effects.     The Wellness Beyond Cancer Program does this through education and referral to supportive     care services and programs offered throughout the city of Ottawa.      Group-based physical activity programs are one of the varied services and programs available     to adults diagnosed with cancer in Ottawa. Such programs are offered through the Ottawa     Regional Cancer Foundation (http://www.ottawacancer.ca) and Breast Cancer Action Ottawa     (http://bcaott.ca). Research on these programs show that group-based physical activity can     improve disease and treatment-related effects while promoting overall quality of life amongst     women with cancer. However, few of these programs have targeted men, even though their needs     and preferences have been shown to be very different from women. While men diagnosed with     colorectal cancer might also benefit from group-based physical activity programs offered in     the community, it is not known if such programs would effectively reach them and what the     impact would be on their quality of life after cancer treatment.      It is believed that a men's group-based walking program could be an effective way to reach     men and promote quality of life after cancer treatment. Therefore, a sustainable 8-week     group-based walking program was developed. This project will seek to explore the feasibility     and potential benefits of the program among men who have completed treatment for colorectal     cancer and who are referred to the program from staff at the Wellness Beyond Cancer Program     in a prospective single-arm trial.   "
4053|NCT03232801|"     The overall aim of this research is to adapt and pilot test a multi-component,     mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.   "
4102|NCT03232164|"     The overall goal of this research is to validate and develop a non-invasive imaging biomarker     of prostate cancer detection, progression, and recurrence. Development of such a biomarker     may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing     for selection of an appropriate risk adaptive therapy.   "
4054|NCT03232788|"     This study will seek to evaluate the predictability and efficacy of a Computer Aided     Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and     hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration.     40 gingival recessions associated with interproximal tissue deficiency will be divided into     two groups: control group (autogenous bone + collagen membrane; n = 20) and test group     (autogenous bone + scaffold; n = 20).   "
4055|NCT03232775|"     Children with autism spectrum disorders (ASDs) have unique social-communication and behavior     impairments that complicate their medical management. This study aimed to evaluate the     effectiveness of using a picture schedule paired with a reinforcement system during the     medical exam. Two groups (treatment and control) of children (ages 5 - 10 yrs) diagnosed with     ASD and below average adaptive communication impairment were asked to participate. Following     participation in an overview of autism diagnostic symptoms training, two teams (comprised of     one chief medical resident and one nurse), blind to the study aim, conducted the study exams.   "
4056|NCT03232762|"     The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and     fats, different in refined grains compared to whole grains as a source of carbohydrates, and     in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is     that there will be differences in the specified outcomes because the proportions of     macronutrients are significant. The primary objective is to detect differences in weight     gain.   "
4057|NCT03232749|"     This study will examine the effectiveness of a single cortisone injection in patients with     shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors     to help predict how a patient with shoulder osteoarthritis will respond to a cortisone     injection utilizing ultrasound giudence.   "
4058|NCT03232736|"     The primary reason the investigators are doing this study are to understand how the right     side of the heart functions in heart failure patients with left ventricular assist devices     (LVADs, or mechanical hearts). Second, the investigators are interested in understanding     how different pacemaker settings influence function of the heart at rest and activity.   "
4060|NCT03232710|"     To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10     mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg     orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects     under fasting/fed condition as well as to monitor the safety and tolerability of subjects.   "
4064|NCT03232658|"     Obstructive sleep apnea (OSA) is a common nocturnal breathing disorder characterized by     complete (apnea) and partial (hypopnea) breathing cessations during sleep. Currently,     clinical diagnosis of OSA is based on the clinical symptoms, especially excessive daytime     sleepiness, and apnea-hypopnea index (AHI) providing a limited overview of the breathing     cessation event frequency during the night. Longer obstruction events and deeper     desaturations have been suggested to be more harmful than shorter and shallower events and     these individual characteristics are completely neglected by conventional and currently used     AHI.      The investigators have previously introduced novel diagnostic parameters incorporating the     number, duration and morphology of individual obstruction events and shown that they improve     the severity estimation of OSA compared to traditional measures. Even though, the novel     diagnostic parameters have so far tackled some of shortcomings of AHI, they need to be     refined to further increase the accuracy of the OSA severity estimation.      It has been shown that age, body mass index (BMI) and sleeping position are strongly related     to the severity OSA. However, it is not thoroughly studied whether the severity of individual     obstruction events progress over time (the aging process) and which factors affect to this     progression. In addition, AHI has poor correlation with excessive daytime sleepiness (EDS)     albeit both of them are used to estimate the severity of OSA.      It is known that OSA patients with similar AHI values, durations of individual breathing     cessation events can differ significantly. Longer and deeper events are connected to     increased mortality rate in patients with moderate or severe OSA and thus, could be     considered to be more detrimental than shorter and shallower ones. However, it has not been     thoroughly investigated whether in severe OSA patients with identical AHI values, sleep     efficiency or hypertension is related to the severity of individual breathing cessation     events.      The investigators planned to explore, whether the individual breathing cessation event     severity progress over time and how different confounding factors affect this progression.     Furthermore, the correlation of EDS with the individual breathing cessation event severity,     sleep structure, and frequency and occurrence of cortical arousals will be investigated.     Also, the investigators will explore whether the percentage time of disturbed breathing from     total sleep time is related to sleep efficiency or hypertension in severe OSA patients having     similar AHI. Moreover, Positional therapy (PT) i.e., the avoidance of the supine posture     during sleep is the treatment of choice for Positional Patients (PP) having most of their     breathing abnormalities while sleeping supine. Since it is known that apneas/hypopneas are     more severe while sleeping supine, this time the investigators will assess the therapeutic     value of PT for severe Non Positional patients (NPP).   "
4065|NCT03232645|"     The objective of the study is to collect data on the use of the Rhythmia HDx mapping system     running commercially available Software Version 2.0 or any future commercially available     Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in     patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF).     The study will collect specific information to characterize the DirectSense technology in     subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a     commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in     order to generate usage guidance on the DirectSense local impedance feature in the management     of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop     a future lesion indexing feature.   "
4066|NCT03232632|"     To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium     for patients with amyloid cardiac injuries.   "
4067|NCT03232619|"     This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of     refractory or recurrent ALL.   "
4856|NCT03222310|"     This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug     interaction study in healthy subjects. The primary purpose of this study is to evaluate the     effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).   "
4068|NCT03232606|"     Physical activity is mandatory to the optimal development and health of children. The     presence of asthmatic manifestations may influence the comportment of children and its family     toward exercise and practice of sports. There no scientific argument to advice a reduction of     physical activity in asthmatic children, but previous studies showed that physical activity     is reduced in asthmatic children.      The aim of this observational study is to evaluate the existing factors leading to this     reduction of physical activity in asthmatic children and their families.   "
4069|NCT03232593|"     This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing     surveillance study will collect information on the the safety and effectiveness of     atezolizumab under the clinical practice, and update the drug label approved by the MFDS in     Korea.   "
4070|NCT03232580|"     Twenty evaluable patients with clinical suspicion or confirmed diagnosis of spondyloarthritis     due to ankylosing spondylitis, or associated with other known clinical conditions like     inflammatory bowel disease, psoriatic arthritis, or undifferentiated spondyloarthropathy.      Five patients will be recruited in the first part of the trial, as a Proof of Concept (PoC)     phase. The PoC phase will assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of     imaging quality, disease-lesion radiotracer uptake and medical relevance to enable the     decision-making to terminate or to continue the clinical investigation completing the     enrollment with the remaining 15 patients.   "
4071|NCT03232567|"     This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety     and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be     screened within 28 days of randomization (Day 1).   "
4072|NCT03232554|"     This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to     Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of     participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu     Pills, one third of participanta will receive Ferrous Sulfate，and the another third will     receive Buxue Yimu Pills and Ferrous Sulfate in combination.   "
4073|NCT03232541|"     Background: Nausea and vomiting (emesis) is a common known problem for patients with cancer     who are undergoing chemotherapy. Emesis affects both the patient´s quality of life and     induces high costs within the health-care system. Acupuncture is an upcoming treatment for     emesis, despite lacking evidence for effects beside non-specific effects since few credibly     sham-controlled studies previously have been conducted. The therapist's care and     communication during the needling sessions may induce non-specific effects, potentially     driven by the patient's expectations. It is not known if the type of communication, in terms     of how positive the therapist communicates regarding expected effects, affects the effect of     acupuncture for emesis.      Aims: The aim of this study is to investigate if chemotherapy-induced nausea, vomiting, and     quality of life differ between patients who receive a) standard care including antiemetics,     b) standard care plus sham acupuncture or c) standard treatment plus genuine acupuncture. The     aim is also to investigate if chemotherapy-induced nausea, vomiting, and quality of life     differ between patients who receive the above mentioned standard care, sham acupuncture, or     genuine acupuncture by a therapist who emphasizes the positive expected outcomes of the     treatment, compared to a therapist who communicates neutral regarding the outcomes.      Procedure: The eligible patients will be randomized to A) standard care, including     antiemetics or to B) standard treatment plus sham acupuncture or C) standard treatment plus     genuine acupuncture. Within the three groups, the patients are randomized to receive either     neutral or positive communication with the therapist during the treatment.      Outcome measures: Nausea and vomiting are documented in questionnaires and in a diary,     measured with Visual Analogue Scales. Well-being, activity level and quality of life are     measured with questionnaires.   "
4074|NCT03232528|"     To evaluate the efficacy of Moxibustion in the treatment of Ulcerative Colitis, thus the     scientific foundation for rational use of Moxibustion in clinical usage, in order to find     admission of the Acupuncture and Moxibustion and even medicine field, accomplish     popularization and application.   "
5300|NCT03216499|"     This phase II trial studies how well HIF-2 alpha inhibitor PT2385 works in treating patients     with recurrent glioblastoma. HIF-2 alpha inhibitor PT2385 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
4075|NCT03232515|"     INTRODUCTION: Accurate estimation of dry weight (DW) is an important and difficult problem in     clinical practice. DW is defined as the lowest weight after hemodialysis (HD) where the     patient will not develop symptoms of hypotension and edema, in addition to not using     antihypertensives. Achieving a fluid balance benefits the control of blood pressure and     reduces cardiovascular risk. In most HD centers, the DW is estimated using a subjective     method dependent on the signs and symptoms that the patient presents. Recently, several     approaches have been studied to develop a standardized DW evaluation technique. Among these,     the analysis of electric bioimpedance vectors (BIVA) has been recognized as a simple and     promising method with high reproducibility.      OBJECTIVE: To use BIVA to improve dry weight estimation in patients with chronic renal     failure undergoing hemodialysis.      Methods: This is a non-randomized pre-test / post-test clinical trial, where the universe of     patients comes from the hemodialysis unit of the General State Hospital of Sonora.      Patients who have limb amputations, pacemakers, metal implants, who are under renal     transplant protocol or who have a renal transplant, and presence of infectious foci will be     restricted from participating.      The diagnosis of DW in the patients will be performed for modification and follow-up. Fluid     status will be evaluated using BIVA. Measurements will be made before and after HD in three     consecutive weekly periods and one one final assessment at three months.      At the beginning of each period, weight, electrolytes, creatinine, total proteins, albumin,     pre-albumin, urea and blood pressure will be measured to calculate the Malnutrition     Inflammation Score and Bilbrey Index. At the end of the HD protocol of each period, body     composition and muscle strength will be evaluated through triceps skinfold, mid-upper arm     circumference and dynamometry. The dialysis dose received will be modified according to BIVA.      The main variables to be considered will be DW, extracellular water and blood pressure.      The duration of the study will be approximately 6 months. In addition, at the end of each     measurement, each participant will be given a nutritional recommendation (feeding guide)     specific to their energy requirements.   "
4076|NCT03232502|"     Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective     serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real     time intervention improve patient outcomes?   "
4077|NCT03232489|"     The purpose of this research study is to evaluate the feasibility in conducting advanced MRI     sequences in a pediatric clinical setting. The study will be observational in nature, and     will only evaluate the studies of pediatric patients who have already been prescribed an     advanced MRI for clinical neurological purposes. The only difference for the subject in     participating in this study is that the data and information about their scan can be used and     disclosed for research purposes, i.e. understanding if the time of the scan, patient comfort,     and quality of the data are feasible. Standard MRI's have been extremely beneficial in the     diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding     advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing     the clinical significance of the data, may improve the benefits of MRI in the future. Within     this scope, the study will be looking at the following factors:        1. The total time of the scan, including:             -  Patient arrival time/lateness             -  Patient preparation time             -  Time scanner is being occupied             -  Patient compliance (is the patient continually stopping the study for breaks, fear,               movement, etc.)        2. Patient dropout rate, including:             -  Change of mind             -  Cost of study is too much             -  Failure to finish the scan        3. Usability of data, including:             -  Movement artifact             -  Patient requiring re-scan for any reason      The scan will consist of two to five advanced MRI sequences that will average between 7-15     minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the     number of advanced sequences depends on the prescription and patient history. All sequences     are performed using a 1.5 Tesla Siemens MRI scanner at Westwood Open MRI, a 3 Tesla GE     scanner at Tower Saint John's Imaging, or a 3 Tesla Siemens MRI scanner at Resolution     Imaging. All scanners are FDA-approved.   "
4078|NCT03232476|"     Clinical trial to investigate effect of voluntary upper extremity loading in combination with     anabolic osteoporosis therapy.   "
4881|NCT03221972|"     The aim of this study was to assess the vitamin D status and analyze risk factors for vitamin     D inadequacy of Chinese children and adolescents aged 6-17y.   "
4079|NCT03232463|"     The purpose of this research study is to evaluate the feasibility in conducting advanced MRI     sequences in a clinical setting. The study will be observational in nature, and will only     evaluate the studies of patients that have already been prescribed an advanced MRI for     clinical neurological purposes. The only difference for the subject in participating in this     study is that the data and information about their scan can be used and disclosed for     research purposes, which is understanding if the time of the scan, patient comfort, and     quality of the data are feasible. Standard MRI's have been extremely beneficial in the     diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding     advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing     the clinical significance of the data, may improve the benefits of MRI in the future. Within     this scope, the study will be looking at the following factors:        1. The total time of the scan, including:             -  Patient arrival time/lateness             -  Patient preparation time             -  Time scanner is being occupied             -  Patient compliance (is the patient continually stopping the study for breaks, fear,               movement, etc)        2. Patient dropout rate, including:             -  Change of mind             -  Cost of study is too much             -  Failure to finish the scan        3. Usability of data, including:             -  Movement artifact             -  Patient requiring re-scan for any reason      The scan will consist of several advanced MRI sequences that will average between 7-15     minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the     number of advanced sequences depends on the prescription and patient history. All sequences     are performed using an FDA-approved MRI scanner.   "
4080|NCT03232450|"     Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO)     and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as     a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization     therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the     wall separating the right and left sides) of the heart.      The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform     Septal Occluder in people with an endocardial device leads reduces the risk of recurrent     stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.   "
4081|NCT03232437|"     A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in     quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following     sites:        1. Forsyth Institute in Cambridge, MA        2. Orange County Research Center in Tustin, CA        3. ActivMed Practices & Research in Methuen, MA   "
4082|NCT03232424|"     This study is a prospective single arm trial designed to study the safety, feasibility and     preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard     adjuvant treatment for newly diagnosed glioblastoma.   "
4083|NCT03232411|"     The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among     men of African Ancestry in Florida and; b) to examine whether smoking increases the     aggressiveness of prostate cancer using several biological approaches.      Investigators plan to contact African American prostate cancer patients regarding     participation. This project has 3 main components. Eligible patients may choose to     participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.   "
4109|NCT03232073|"     The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy,     safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The     AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of     this long term extension of the core study AC-058B301 is to characterize the long-term     safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.   "
4110|NCT03232047|"     The objective of the study is to evaluate if working memory training is effective in     improving working memory of MCI patients. Further, to evaluate if cognitive training relates     to the function and structure of the brain.   "
4084|NCT03232398|"     Patients with acute ST-segment elevation myocardial infarction (STEMI) have an elevated risk     of stroke, most of which are cardio-embolic in origin as a result of left ventricular (LV)     thrombus formation. Anterior-wall location of a MI, in particular, can lead to the     complications of LV aneurysm and/or thrombus, which some estimate occurs in approximately up     to one-third of individuals within the first 2 weeks following an anterior MI.      In the absence of anti coagulation, the risk of embolization in patients with a documented LV     thrombus has been reported to be between 10 and 15 percent [3]. Although there are no     randomized trials evaluating the efficacy of anticoagulation in patients with an LV thrombus     after MI, observational studies provide substantial supporting evidence for the     recommendation to anticoagulate patients with documented LV thrombus in order to reduce the     risk of embolization. The observation that most events occur within the first three months     from the MI forms the basis for the recommendation that anticoagulant therapy should be     started early and continued for at least three to six months after myocardial infarction.     Currently the practice guidelines recommend anticoagulation after MI only in certain settings     such as the presence of LV thrombus or atrial fibrillation. To date there are no data on the     use of novel oral anticoagulants (NOACS) for stroke prevention in the setting of LV thrombus     after acute MI.      The proposed aim of this randomized open label non inferiority clinical trial is to assess     whether apixaban is as effective as VKA for the treatment of LV thrombus after acute ST     segment elevation MI.      Population: Patients with evidence of LV thrombus as assessed by trans-thoracic     echocardiography (TTE) 3 to 7 days post admission for acute ST-elevation MI      Intervention: The patients will be randomly assigned to treatment with apixaban or s.c     enoxaparin 1mg/Kg BID followed by dose-adjusted warfarin to achieve a target international     normalized ratio (INR) of 2.0 to 3.0 for 3 months.      The study Outcomes are the presence of LV thrombus as assessed be echo, major bleeding, and     stroke or systemic embolism and death from any cause.   "
4085|NCT03232385|"     The objective of this research is to evaluate functional validation of the MR-US fusion for     the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system     performance.   "
4086|NCT03232372|"     When an implant is placed, it is assumed that there will be a loss of bone in the more     coronal area around it. The placement of the implant in relation to bone level, either     crestal or subcrestal and the type of connection chosen, either external connection or     internal connection, have been related as one of the factors that caused this loss. The     preservation of the peri-implant bone influences the shape and contour of the underlying soft     tissues, which are important for the aesthetic result of the treatment and for the success of     the same.      Hypothesis: The hypothesis is that there are no differences between the external and internal     connection with regard to marginal bone loss. In implants placed at the crestal and     subcrestal level, the hypothesis is that there is greater marginal bone loss in implants     placed at the subcrestal level.      Objectives: Main: To evaluate the marginal bone loss around implants of internal connection     and external connection. Secondary: To compare the loss of bone in implants of internal     connection placed at crestal and subcrestal level. To evaluate intra and post-operative     complications.      Material and methods: A prospective and randomized radiological study will be performed. 150     implants will be placed in patients who must present partial edentulism and require the     replacement of at least 2 crowns on implants in the same jaw. In a randomized manner,     implants of external connection and internal connection will be placed. Other features such     as surface treatment type of the implant will be similar in both types of implants to reduce     bias.      With this study the investigators will try to define if there is a procedure in when to the     connection of the implant and the location of this, that is more beneficial with respect to     the preservation of bone.   "
4087|NCT03232359|"     Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has     been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is     able to discriminate between patients with TTP/HUS or SPE/HELLP   "
4103|NCT03232151|"     The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the     available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently     widely available worldwide in interventional angiography suites to enable acute ischemic     stroke patients to be imaged, triaged, treated, and assessed using a single modality in one     room.   "
4088|NCT03232346|"     This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy     of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with     long--acting naltrexone (XR--NTX) and to compare it to the standard method of gradual BUP     taper.Individuals with opioid use disorder (OUD) (N=60) who have successfully completed at     least 6 months of buprenorphine treatment and do not wish to remain in a long--term     buprenorphine maintenance program will be recruited. The first phase includes a 4--week     period of stabilization on buprenorphine 4--8 mg at the research clinic to assure that     patients are stable, compliant, and free from illicit opioids. Participants that meet the     above criteria will be randomized 1:1 to: 1) buprenorphine discontinuation and outpatient     transition to XR--NTX with 3 monthly injections, or 2) buprenorphine discontinuation using a     gradual 5-week long taper. In both groups participants will receive weekly relapse prevention     therapy and will be monitored for the duration of the trial, which is 25 weeks post     randomization.   "
4089|NCT03232333|"     This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within     12 weeks of treatment.   "
4090|NCT03232320|"     To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared     with placebo (normal saline)   "
4091|NCT03232307|"     The goal of this clinical research study is to learn if a combination of ibrutinib,     rituximab, and lenalidomide can help control newly diagnosed mantle cell lymphoma (MCL) in     patients over 65. The safety of this drug combination will also be studied.   "
4092|NCT03232294|"     Abnormal fetal development such as macrosomia can cause some complications on both fetus and     mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy     examination that it can be obtained during an examination of a pregnant woman by ultrasound.     Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and     increase childbirth complications and operative birth. There are some studies scrutinizing     the relationship between FAWT and diabetes in the literature. However there are few studies     which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal     outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators     wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome     regarding with macrosomia in the second trimester.   "
4093|NCT03232281|"     To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in     Chinese female subjects with endometriosis by demonstrating the non-inferiority of     triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate     PR 1-month formulation injected 3 times consecutively.   "
4094|NCT03232268|"     This study aims at evaluating the safety of an approach based on HLA-mismatched     Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies     who are ineligible to conventional allograft   "
4096|NCT03232242|"     Infectious disease leads to deaths that accounted for more than 25% of all causes of human     mortality. But the traditional microbiological diagnostic methods such as specimen culture     are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and     viruses may be difficult to cultivate and isolation. Therefore, the accurate identification     and rapid classification of pathogenic microorganisms is very important for the patient's     precise diagnosis and timely treatment.      Small-scale studies on the diagnostic efficacy and prognosis of infection in the next     generation have been shown to provide early diagnosis and targeted medication guidance for     bloodstream infections and respiratory infections, but the larger-scale validation of     next-generation sequencing Technology in the diagnosis and treatment of infectious diseases     in the human body is relatively rare.      The purpose of this study is to provide rapid etiological diagnosis of patients by means of     next-generation sequencing, to change the way of treatment of patients under the existing     traditional pathogen detection by means of accurate description of pathogens and monitoring     their dynamic changes, and to provide patients with more accurate treatment.   "
4097|NCT03232229|"     The aim of this observational study is to examine supplementation (e.g. caffeine or creatin)     use in both male and female professional tennis players.   "
4098|NCT03232216|"     This study evaluates the effect of Vitamin D3 supplementation in healing rate of tibia     fractures in adult patients with low vitamin D. Half of participants will receive Vitamin D3     supplementation while the other will receive placebo.   "
4099|NCT03232203|"     STRIMVELIS is a medicinal product developed by GSK that restores adenosine deaminase (ADA)     function in hematopoietic cell lineages, thereby preventing impaired immune function.     STRIMVELIS is indicated for the treatment of patients with ADA- severe combined     immunodeficiency (SCID), for whom suitable human leukocyte antigen (HLA)-matched related stem     cell donor is not available. The objective of this study is to evaluate the effectiveness of     routine and additional risk minimization measures by assessing the understanding of referring     health care providers (HCPs) and parents/carers (hereby referred as participants) with regard     to the specific risks associated with STRIMVELIS. In this cross-sectional study, surveys will     be provided to referring HCPs and parents/carers of children approximately six months after     treatment with STRIMVELIS. The study will recruit for approximately two years until 10     referring HCPs and 10 parents/carers have completed their respective surveys. STRIMVELIS is a     trade mark of the GSK group of companies.   "
4100|NCT03232190|"     The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of     the newborn. Preterm children are at greater risk for developmental disorders. On the one     hand, this is due to cerebral complications inherent to the prematurity, on the other hand it     is related to the very early and therefore vulnerable stage of brain development at the time     of the premature birth. The development of the child is also the result of a constant     interaction between the infant and its environment, primarily the primary caregiver (i.e. the     parents). A premature birth can cause great stress to parents, and there are several     obstacles that can make it difficult to handle their child. Therefore, we have developed a     web application that supports parents until their child reaches the age of two. By keeping     them informed, we hope to make them more confident in their role as parents, and thus     facilitate the parent-child interaction. In order to determine whether this form of support     has an additional effect on the development of the premature child, we compare two groups of     premature infants and a group of non-premature infants.   "
4104|NCT03232138|"     This research study involves taking an experimental anti-cancer dietary supplement called     Sulforaphane (SF) or a placebo (product without any supplement content) over a period of     twelve months in order to determine if it is a useful dietary supplement for prevention of     lung cancer in humans.      The main goals of this research study are:        1. To learn about the effects of giving Sulforaphane (SF) to former smokers who are still          at high risk of developing cancer due to their smoking history and whether or not their          condition improves, stays the same or becomes worse after Sulforaphane (SF) is given.        2. To learn whether Sulforaphane (SF) might reverse some of the lung cell changes          associated with future development of lung cancer.   "
4105|NCT03232125|"     Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads     to changes in ventricular re-polarization. This in turn can result in changes of heart     rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor     antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed     in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this     study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular     adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg     position.   "
4106|NCT03232112|"     The study is a double-blinded, randomized, placebo-controlled, 26-weeks clinical trial. The     objective of the trial is to investigate the effects of the GLP-1 receptor agonist Bydureon®     (exenatide) vs. placebo on alcohol intake in patients with a diagnosis of alcohol dependence.   "
4107|NCT03232099|"     Recent evidence indicates that Trimethylamine-N-oxide (TMAO) is a pro-atherosclerotic,     phosphatidylcholine-dependent metabolite of diet and intestinal flora. Food substrates derive     from carnitine and phosphatidylcholine (lecithin), present mainly in eggs, red meat, liver     and pork. The intestinal flora pattern that favors the formation of TMAO is very similar to     that which predisposes to insulin resistance and obesity: a high proportion between phylum     Firmicutes over Bacteroidetes. The intestinal microbiota is sensitive and variable; the use     of prebiotics and probiotics can change the relationship between Firmicutes/Bacteroidetes     phyla. Red wine (RW), for its composition with polyphenols and possible bactericidal role,     may play a role in the intestinal flora modification and could promote proliferation of     beneficial bacteria. However, the influence of RW on TMAO is not known. This is the     hypothesis to be tested in this trial. METHODS: This is a prospective, crossover, randomized,     controlled trial with patients from Heart Institute (InCor), FMUSP and volunteers recruited     through press releases. We will evaluate 42 patients, all men, with established     atherosclerotic disease. Patients will be evaluated in a crossed manner: each subject     receives both treatments, intervention and control (in random order), and they will be     divided into 2 groups: A and B. In the first intervention stage, after 2 weeks of washout for     all patients , group A receives Red Wine (RW) and group B is the control, abstemious. In the     2nd stage of intervention, after 2 weeks of washout for all patients the groups are inverted:     group B receives RW; and group A will be abstemious. In the period with wine intervention,     patients will receive 250 mL/day of red wine per day, for 5 days of the week, for 3 weeks.     Patients will maintain their usual diet without the use of prebiotics or probiotics, or other     polyphenolic derivatives. At the beginning and at the end of each stage, patients will be     submitted to serum TMAO and intestinal microbiota evaluation. For the intestinal microbiota     evaluation, the new generation sequencing will be used in the highly preserved portion of the     16S subunit of the rRNA gene. The determination of TMAO in plasma will be by liquid     chromatography coupled to mass spectrometry. Expected results: It is expected to determine if     RW acts on the intestinal flora to the point of influencing plasma TMAO concentration.   "
4111|NCT03232034|"     Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2     diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal     ingestion in humans. However, these nutrients may interact synergistically (and with other     minerals in milk) such that specific co-ingestion of these nutrients is required to obtain     the full therapeutic potential for metabolism and energy balance. This proposal is to perform     a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone     responses.   "
4112|NCT03232021|"     The aim of this study is to assess the effect of pregabalin administration on     catheter-related bladder discomfort (CRBD). The study group includes patients that are about     to be subjected to orthopedic operations.   "
4113|NCT03232008|"     This study investigates the effects of Canderel, an aspartame and acesulfame-k blend     artificial sweetener powder, on post-postprandial blood glucose levels and appetite scores.     Participants will be randomly given either the placebo drink (3g of maltodextrin dissolved in     250ml of water) or the Canderel drink (3g of Canderel dissolved in 250ml of water) alongside     an isocaloric breakfast. Blood glucose measurements will be obtained through finger pricking     and appetite will be measured using self-reported visual analog scores rating hunger, desire     to eat, fullness and alertness for up to 3 hours after breakfast.   "
4114|NCT03231995|"     Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in     1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related     to, among other things, its respiratory or neurological complications, observed especially in     children. Early determination of the severity of influenza is a critical step to avoid in     appropriate treatment and care for patients and to improve their survival. Viral, human but     also environmental factors have been described as having an important role in determining     this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in     the incidence and severity of respiratory viral infections. During influenza infection, the     respiratory microbiota is significantly altered. In animal models, particularly murine     models, the microbiota regulates the immune response to influenza virus infection. In a     retrospective preliminary study, the investigators showed that the composition of the     nasopharyngeal bacterial microbiota is different between children who develop a severe or     moderate influenza. This difference was observed on respiratory specimens at admission to     pediatric emergencies within two days of onset of symptoms.      Hypotheses :        -  The respiratory microbiome is a determining factor in the clinical course of influenza          infection (benign vs. severe with respiratory or neurological complication)        -  The respiratory microbiome can be used as a prognostic biomarker of the clinical course          of influenza Originality: There are currently no clinical and / or virological markers          to predict the clinical course of influenza infection. This study will define biomarkers          of the respiratory microbiome to discriminate patients who will develop a severe          influenza from those who will develop a moderate influenza. These prognostic biomarkers          could be used to rapidly refer patients at risk to intensive care units, thus improving          patient management and care. Moreover, at the fundamental level, this study will specify          the role of the microbiome in the severity of influenza infection.   "
5674|NCT03211624|"     This is a prospective, multi-center, case-control study where neurocognitive function will be     evaluated in 36 patients with Cushing syndrome (CS) and 36 controls matched for age, gender     and education.   "
4115|NCT03231982|"     To evaluate the efficacy and safety of amlodipine besylate and candesartan cilexetil     administered in a fixed-dose combination tablet versus co-administered as their separate     formulations in patients with essential hypertension who have shown inadequate response on     monotherapy of amlodipine or candesartan cilexetil or who are with blood pressure adequately     controlled by co-administration of amlodipine besylate and candesartan cilexetil single     agents   "
4116|NCT03231969|"     To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to     vehicle for the treatment of the signs and symptoms of allergic conjunctivitis   "
4117|NCT03231956|"     To investigate the relationship between initial ClearSight™ derived hemodynamic parameters     and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with     acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9,     and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor     infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic     Group).   "
4120|NCT03231917|"     We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and     air insufflation for inspection of mucosa on withdrawal. In one randomized group, water     infusion will be employed as the first method for mucosal inspection while in a second group,     CO2 insufflation will be used first. This study will be different than usual care since the     participants will receive two successive or tandem colonoscopies versus one   "
4121|NCT03231904|"     In 2010, Simamura et al have demonstrated in a rat model that one of the pro-inflammatory     cytokine belonging to the Interleukin-6 family cytokines, LIF, is required for the     proliferation of neuronal progenitor cells in the cerebrum. They have shown that maternal LIF     induces ACTH from the placenta, which in turn stimulates fetal nucleated red blood cells to     secrete LIF, leading finally to neurogenesis in the fetus As demonstrated recently in a mouse     model, maternal inflammation suppress the physiological maternal— fetal LIF—ACTH—LIF signal,     result in reduction of ACTH production from placenta, which lead to a reduction in LIF     concentration in fetal Cerebrospinal fluid (CSF) and impaired proliferation of the neural     stem/ progenitor cells and poor development of the fetal brain.      In the current study, the investigators will take fetal and maternal blood samples of fetuses     undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the     routine blood samples before performance of TOP , fetal blood samples will be acquired from     the umbilical vessel after the termination has been completed , the blood samples will be     analyzed for levels of LIF and ACTH and checked according to termination pregnancy week,     Patients electronic files will be checked for relevant demographic and obstetric information.   "
4136|NCT03231709|"     The purpose of this study is to examine the patient preference for treatment with once-weekly     dosing of DPP-4 inhibitor trelagliptin versus once-daily dosing of DPP-4 inhibitor alogliptin     among the participants with type 2 diabetes mellitus who are being treated with once-daily     dosing of DPP-4 inhibitor.   "
4137|NCT03231696|"     We assessed the visibility of peripheral nerves while ultrasound guided blockades with a     novel scoring system to evaluate differences in visibility of different nerves.   "
4144|NCT03231605|"     Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The     susceptible population is Children and adolescence, also the morbidity in adult presented     rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important     role in National Immunisation Program(China). The aim of this experiment is to verify the     effects of experimental group non-inferior than control group. The experiment methods is     compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between     experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two     Hepatitis A Vaccines in 18-24 months Chinese Children.   "
4122|NCT03231891|"     The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals     interested in participating in studies focused on inherited cancer predisposition the     opportunity to enroll in a research registry. Efforts through the registry include, but are     not limited to, contribution of data to observational studies, targeted gene-specific     studies, and education and outreach efforts for both participants and recruiting healthcare     providers. Participants are given the opportunity to learn about and participate in other     efforts for which they may be eligible.      All participants and recruiting healthcare providers receive educational newsletters twice     per year which contain research and clinical updates in the field of cancer genetics.     Providers who recruit patients can also access monthly web-based genetics case conferences     which focus on different topics each month and are generally attended by a guest expert who     provides background information on the topic as well as comments on the case presentations.      Participation in ICARE involves completion of an informed consent form, baseline     questionnaire, follow-up questionnaires every two years, and medical record/tumor releases,     as applicable. There is no cost to participate and all correspondence can be facilitated     through phone, email, or mail.      Enrollment can be completed either through a traditional paper-based consenting method (i.e.     postal mail) or through the online enrollment option available on the ICARE website     (InheritedCancer.net). If you are a patient interested in learning more or a provider     interested in recruiting to ICARE, please visit our website where you may complete an online     contact form requesting a study team member contact you.   "
4123|NCT03231878|"     This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two     parallel-group study in male patients with the AMN phenotype of X-linked adrenoleukodystrophy     (X-ALD) to assess the efficacy and safety of MIN-102 treatment. Study sites will consist of     specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).   "
4124|NCT03231865|"     ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is     implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non     invasively. Non invasive and invasive optical measurement of ZnPP will be compared.     Additionally ZnPP measurements will be compared to other iron deficiency parameters for     validation by the investigators.   "
4125|NCT03231852|"     The objective of our study is to determine which factors affect willingness to participate in     gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will     be approached to complete a survey assessing willingness to participate in clinical trials.     The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess     willingness to participate.   "
4126|NCT03231839|"     This study investigates the influence of red meat and fibers on glucose metabolism and body     fat composition in subjects at increased risk for type 2 diabetes.   "
4127|NCT03231826|"     Patients are screened for significant arrhythmias and other possibly significant ECG-patterns     directly after discharge and two weeks after myocardial infarction using wearable devices.     The home monitoring data will be linked with extensive data from electronic health records     collected before, during hospital stay and after discharge.      The purpose of the study is to clarify whether home monitoring of continuous ECG-signals can     be used to predict and prevent serious adverse events after myocardial infarction.   "
4129|NCT03231800|"     A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age     with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.   "
4130|NCT03231787|"     National, randomized, open, parallel, multicenter clinical trial of two comparison groups     that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the     surgery time in antiaggregated patients with proximal femur fracture.      The experimental group will undergo surgery as soon as platelet aggregability, according to     the PLATELETWORKS® method is correct within 24-48 hours.      The control group will undergo surgery according to the usual practice of the center taking     into account the safety time of the antiplatelet agent.   "
4131|NCT03231774|"     This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart     Catheterization in Terms of accuracy to measure hemodynamic parameters.   "
4132|NCT03231761|"     This is a randomized controlled trial examining the impact of videos on medical students'     implicit and explicit attitudes and knowledge related to mental illness in Nepal. Medical     students are randomized to one of three conditions: (a) no video, (b) a didactic video based     on the mental health Gap Action Programme (mhGAP) modules for depression and psychosis; and     (c) videos with personal testimonials from mental health service users with depression and     psychosis.   "
4133|NCT03231748|"     This study will be conducted in patients with sepsis and acute kidney injury needing renal     replacement therapy.      The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter     leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.   "
4134|NCT03231735|"     The purpose of this study is to determine, in preterm infants less than 37 weeks gestation     with respiratory distress who are ventilated in the first 48 hours after birth, if mid     frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared     with standard frequency ventilation strategy using ventilator rates of ≥ 20 to < 60 per     minute will increase the number of alive ventilator-free days after randomization and reduce     the risk of ventilator induced lung injury.   "
4135|NCT03231722|"     -  The association of FOLFOX (5-fluoruracil, folinic acid, and oxaliplatin) and pan is a          standard option for the first-line treatment of unresectable RAS and BRAF wt mCRC          patients.        -  The phase III TRIBE trial recently demonstrated that FOLFOXIRI (5-fluoruracil, folinic          acid, oxaliplatin and irinotecan) plus bev significantly prolongs PFS and OS and          increases RECIST response rate, ETS and DoR, as compared to FOLFIRI (5-fluoruracil          folinic acid, and irinotecan) plus bev. The advantage provided by the intensification of          the upfront chemotherapy backbone is independent of RAS and BRAF mutational status.        -  Some phase II trials recently assessed the safety and activity of the combination of          three-drugs chemotherapy regimens with an anti-EGFR monoclonal antibody. Promising          activity results in terms of RECIST response rate and R0 resection rate have been          achieved, with some safety concerns with special regards to gastrointestinal toxicity.        -  In the phase II randomized MACBETH study the combination of a modified schedule of          FOLFOXIRI with cetuximab determined remarkable activity results, with an acceptable and          manageable safety profile.        -  The optimal duration of the upfront treatment with chemotherapy plus anti-EGFRs is not          established. The phase II MACRO-2 trial suggested that interrupting FOLFOX after 4          months while continuing cet alone as maintenance, is a reasonable option.        -  Activity parameters (RECIST response rate, ETS, DoR) are clinically relevant endpoints,          associated with longer survival, in particular with anti-EGFR moAb-based treatment.      On the basis of these considerations, we designed the present phase III randomized trial of     first-line mFOLFOXIRI plus pan versus mFOLFOX6 plus pan in RAS and BRAF wt unresectable mCRC     patients.   "
4138|NCT03231683|"     The investigators want to investigate the effect of low dose S+ ketamine compared to placebo     on cumulative morphine consumption at 24 hours in 90 women undergoing open abdominal     hysterectomy with remifentanil-propofol target controlled infusion (TCI) in KK Women's and     Children's Hospital. The secondary aims are to investigate the use of low dose S+ ketamine on     the incidence of nausea, vomiting, pruritus (opioid side effect), sedation score and psycho     mimetic assessment compared to placebo group. The investigators propose to conduct a double     blinded, randomized controlled study in women undergoing open abdominal hysterectomy with     remifentanil-propofol TCI. (1) Treatment Group: intravenous ketamine 0.5 mg/kg at the     beginning and 0.5 mg/kg 20 minutes before extubation. (2) Control Group: intravenous normal     saline (as placebo) at the beginning and 20 minutes before extubation.   "
4139|NCT03231670|"     Pulmonary bacterial infections such as exacerbations of chronic bronchitis, nosocomial and     community-acquired pneumonia represent a major public health issue. Antibiotics have shown     their efficacy by direct antimicrobial activity and their limit particularly in case of     multidrug-resistant microorganisms or in treating patients with aggravating pathologies.     Innate immunity could be an alternative or complementary therapeutic pathway. Innate immunity     receptors bind universal and invariant microbial molecular patterns present in bacteria,     virus, fungus or parasite. Toll-like Receptors (TLR) activation by microbial agonist     stimulates the innate immunity response which results in the production of chemokines,     cytokines, antimicrobial molecules and the recruitment of innate cells.      The  Pulmonary Infection and Innate Immunity  team of the Immunity and Infection Center in     Lille (Group of Dr. Sirard and Carnoy) has a long expertise in the study of TLR5 and its     agonist, the flagellin, a structural protein of bacterial flagella. TLR5 is expressed on the     cell surface of macrophages, monocytes, dendritic and epithelial cells. Several studies in     mice have shown the flagellin prophylactic potential during bacterial infections through a     TLR5 dependent stimulation of innate immunity. Recently, the group of Dr. Sirard and Carnoy     has shown that flagellin can be used in association with antibiotics to treat Streptococcus     pneumoniae respiratory infections in mice. The results demonstrate that an agonist of TLR can     increase the therapeutic index of an antibiotic and improve the pulmonary anti-infectious     reaction. This innovative approach allows us to consider new antibacterial strategies where     antibiotics have reached their limit (nosocomial infection, multidrug-resistant bacteria…).     TLR agonists can activate multiple human cell type. Indeed, blood cells activation by TLR     agonists have been recently characterized in healthy volunteers.      However, there is no available data on the ability of TLR agonists to activate cells from     patients with infectious pneumopathies. A study in these patients is inevitable if one is to     consider the therapeutic use of agonists in respiratory pathologies.   "
4140|NCT03231657|"     Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality worldwide.     The morbidity and mortality of this condition arises from two main causes: 1) the lack of     specific and sensible methods for its diagnosis and prognosis, 2) and the fact that the     course of the disease is often unpredictability at its presentation and speed of progression.     The majority of deaths are undoubtedly avoidable and are due to a substandard care. Nowadays     it's known that preeclampsia is a placental disorder that is characterized by an unbalance of     angiogenic and antiangiogenic factors. It has been recently proven that the ratio of sFlt-1     to PlGF in women who presented with a clinical suspicion of preeclampsia is useful     distinguishing between women in whom preeclampsia would develop and those in whom it would     not. A low ratio also predicted the absence of fetal adverse outcomes in the same time frame.     In addition this ratio demonstrated to be useful to discriminate among patients that would     developed maternal or fetal adverse outcome. Correct identification and diagnosis of women at     risk could potentially prevent all these adverse outcomes thus, clinical experience suggests     that early detection and monitoring are beneficial.      EuroPE aims to provide evidence that the re-definition of pre-eclampsia as an entity caused     by a placental unbalance of angiogenic and anti-angiogenic factors and its incorporation in     the diagnosis and classification of the disease would improve maternal and neonatal health.      This will be an open, multicentre, international, randomised controlled trial with an     intention-to -treat analysis. The study is pragmatic: it will be undertaken to reflect real     clinical practice rather than the very tightly controlled circumstances of explanatory     trials. The main objective of this study is to determine the effects of the use of the ratio     as a diagnostic tool in the definition and classification of PE, as compared with its usual     definition, in triage and delivery decisions and to see whether this new approach is able to     improve maternal and perinatal outcomes.   "
4141|NCT03231644|"     The FD/MAS Patient Registry is an IRB-approved research study that that invites the patients     and families to help answer some of the biggest questions about FD/MAS by completing     questionnaires about their lives with FD or MAS.      Have you enrolled in the FD/MAS Patient Registry yet? Are you up-to-date on your surveys?     Take a trip to www.fdmasregistry.org today to learn more about the project, enroll, complete     your surveys, or make sure you aren't due to provide more info!      The FD/MAS Patient Registry: Your story powers research.   "
4142|NCT03231631|"     Cardiovascular diseases are a leading cause of death worldwide. Some of the risk factors that     have been identified are considered as be non-modifiable and modifiable. Among the     non-modifiable, gender, age, race, family history and pathological antecedents such as     diabetes and hypertension among others are taken into account. The modifiable factors are     weight, abdominal circumference, habits such as smoking, alcohol consumption, diet and     especially the EXERCISE.      In order to modify these risk factors, patients are submitted to a strategy of health     promotion, disease prevention, pharmacological treatments, non-invasive and invasive     treatments such as cardiac catheterization, balloon coronary angioplasty and / or stent     implantation, cardiovascular surgeries etc. However, one of the most important strategies     that should be of great importance is to involve the patient and his family in these     treatments through education and follow-up strategies whether it is through the telephone,     home visit, e-mail, messages, etc. In this way, the patient is brought to a state of     self-determination and self-awareness that leads him to perform physical activity routinely     so he can change his cardiovascular risk factors and become a patient adherent to exercise or     any other treatment. This is where the importance of exercise or aerobic physical activity is     emphasized, as it is a low-cost activity that can be performed by any type of patient, and     that results are easily observed in physical and physiological changes that can be     objectively measurable, such as the levels in serum lipid profile (cholesterol,     triglycerides, LDL and HDL), or cardiovascular function tests such as stress tests with METs     indicating increased aerobic capacity (Improvement in ability to withstand a stress test).      Therefore, the purpose of this study is to submit a group of patients to an education and     telephone follow-up plan, emphasizing on the importance of performing physical activity with     the appropriate intensity and frequency so that they can include it within their daily     routine by itself and ensure the adherence to physical activity.      Physiological changes that these patients may present as a consequence of the acquired     routine physical activity by being subject to the education and telephone follow-up plan of     this research will be measured with serum HDL levels in a clinical laboratory test and MET in     a stress test.   "
4143|NCT03231618|"     This study is a randomized crossover (2 × 3) dietary intervention. 40 male volunteers(20     normal weight, 20 overweight / obesity, no other serious disease or metabolic abnormalities)     aged 18-45 years are required to take 3 kinds of isocaloric diets with different amounts of     macronutrients: low-fat high-carbohydrate diets, low-carbohydrate high-fat diets and     high-protein low-fat diets. The comparison is made within subject before and after the test     meal. Each subject takes 6 meals of 3 kinds of diets on 6 separate days with a washout period     between different diets. The study protocol was approved by the Ethics Committee of Shanghai     Institutes for Biological Sciences and all participants provided written informed consents.     The study is the first to investigate among overweight / obesity and normal weight in China     to clarify:        1. the relationship between the proportion of macronutrients in diets and the energy          metabolism efficiency.        2. the main genetic and non-genetic factors that impact individual energy metabolism, the          characteristics of metabolic profiling and relative regulatory pathways.   "
4765|NCT03223493|"     The ACTION (Awareness, Care, and Treatment In Obesity management) study aims to identify     perceptions, attitudes, behaviours, and potential barriers to effective obesity care across     three respondent types: 1) People with Obesity, 2) Healthcare Providers and 3) Employer     Representatives in the US. Data is collected via online surveys using a cross-sectional,     US-based stratified sample design.   "
4145|NCT03231592|"     In 1986, The Pioneer Valley in Western Massachusetts was home to one of the first two     community supported agriculture (CSA) businesses in the USA. In 2014, there were 6,200 CSAs     across the states, and today, in the Pioneer Valley alone, there are sixty CSAs. As with many     parts of the United States, there are too many CSAs competing for the same pool of middle and     upper-class customers. In his research at the University of Massachusetts in 2014, Mark Paul     stated CSA farms are trapped in a lose-lose conundrum in which the farmers are not making     enough money for a living wage, while simultaneously CSA shares are too expensive for many     community members. The central challenge facing the CSA model moving forward is to provide     fair compensation to farmers and farm workers, while making shares available at prices that     can attract more members of the community. (Im)Proving the CSA Model proposes to increase     consumption of and access to local products AND to develop new market opportunities for farms     by opening the CSA membership base nationwide to low-income consumers and more price     conscious middle class consumers. The investigators will do this by researching and     documenting the health benefits of belonging to a CSA program. The investigators expect the     resulting data to justify insurance-provided cash wellness benefits for CSA participation,     much like those currently provided for gym membership. A wellness benefit will provide the     financial incentive necessary to open CSA programs to lower- and middle-income consumers.      The two-year research study intends to demonstrate that enrolling community health center     patients in a Community Supported Agriculture (CSA) program is feasible and leads to dietary     improvements that would be expected to offer clinical benefits in larger scale studies over     longer timeframes. To maximize the knowledge gained from participation in this study, the     investigators will measure several self-reported, laboratory, and clinical outcomes, but the     primary purpose of this study is to provide pilot data for the model.      To test this the investigators will implement a randomized controlled clinical trial design,     with individual-level randomization of 120 participants, assigned in 1:1 ratio to receipt of     a CSA membership (goal: 60 participants) or enhanced usual care (goal: 60 participants).   "
4146|NCT03231579|"     This multi-site study will enroll approximately 200 CLL patients across 7 cancer     institutions. The aim of the project is to ensure hematology care teams that are     participating in new value-based reimbursement models have an accurate understanding of the     evidence and roles of new therapies for relapsed/refractory CLL and best practice supportive     care protocols to proactively assess, monitor, and manage symptoms to promote successful     clinical outcomes. Hematology teams at seven health systems across the U.S. will be given     online clinical training on the latest evidence for treatment planning in CLL along with best     supportive care practices for patients on novel CLL treatments, prior to using Carevive's     patient engagement software.      Once training is complete, CLL patients with relapsed/refractory disease will use the     Carevive patient portal to report any symptoms at and in between clinic visits.     Patient-reported and clinical data will be processed by the Carevive rules engine technology     to generate evidence-based supportive care plans providing patients with direction regarding     self-management strategies, care coordination for relevant cancer center services, and     direction on when to go to the emergency department (ED) or call their hematologist based on     their institution's protocol. On the visits subsequent to the delivery of the care plan,     patients will report on the perceived effectiveness of the intervention (or barriers to     non-adherence to the intervention).      Outcomes focus on the effectiveness of current evidence-based, best supportive care practices     in improving QoL and mitigating ED visits/hospitalizations. This project will lay the     foundation for new supportive care delivery models incorporating professional education and     patient engagement tools to improve clinical outcomes. The research team will collect     real-world evidence for predictive modeling of symptoms for the relapsed/refractory CLL     patient population and evaluate the effectiveness of current evidence-based supportive care     recommendations to inform and improve future practice.   "
4147|NCT03231566|"     To determine if education about pain given prior to Knee Arthroplasty will result in better     outcomes following surgery   "
4148|NCT03231553|"     The trial aims to determine whether or not MiQuit (text-message support programme) is     effective when offered in addition to standard behavioural support for smoking cessation in     pregnancy.   "
4149|NCT03231540|"     This study evaluates the effect of whey protein enriched enteral nutrition in addition to     exercise training on the preservation of muscle function in critically ill patients.      One half of patients receive whey protein enriched enteral nutrition with a protein intake of     1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein     intake of 1 g/kg/day.   "
4150|NCT03231527|"     retrospective multicentric database for the analysis of the long term outcomes of total     arterial CABG in comparison to saphenous vein based CABG   "
4151|NCT03231514|"     The study will examine the performance and body composition effects of ketogenic vs     carbohydrate-based diets, determine the carbohydrate tolerance (carbohydrate threshold) for     active individuals on a ketogenic diet, and then, reexamine the performance and body     composition effects when the diets are modified with supplemental carbohydrate up to the     newly defined ketogenic threshold.   "
4152|NCT03231501|"     This is an open-label study, to evaluated epitinib, which is a selective epidermal growth     factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with     EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of     EGFR may provide a novel mechanism in treating glioblastoma.   "
4153|NCT03231488|"     Can mindfulness help with attention and emotion difficulties after a brain injury?      People who have a brain injury often have problems with their attention and emotions. This     study will see if a short mindfulness task can help with these problems. So far, there are     not many studies looking at this and those that do show mixed results. When being mindful     someone is aware of their attention and focuses on the present moment without passing     judgement. This study focuses on over-selectivity and selective attention to threat after a     brain injury. These are two concepts involved in attention and emotion problems.     Over-selectivity is when someone focuses on only one thing around them and misses other key     things. Selective attention to threat is when someone's focus is drawn to something around     them that is seen as threatening. This has been shown to cause and keep anxious feelings     going. This research will see if a short mindfulness task can help those with a brain injury     by reducing overselectivity and selective attention to threat on two tasks. Participants will     be recruited from NHS and non-NHS brain injury services. The study will take around two hours     to complete for each participant. In summary, this study looks to see if a specific     mindfulness exercise can be helpful for specific attention and emotion problems. It could be     a first step in making treatment better and giving more treatment options for those with a     brain injury.   "
4154|NCT03231475|"     This study will treat patients with advanced NSCLC who have already received at least one     course of specific anti-cancer treatment but the tumour has started to re-grow following that     treatment. This is the first time this drug has ever been tested in patients, and so it will     help to understand what type of side effects may occur with the drug treatment, it will     measure the levels of drug in the body, it will also measure the anti-cancer activity. By     using these pieces of information together the best dose of this drug to use in further     clinical trials will be selected.   "
4155|NCT03231462|"     This prospective cohort study examines the impact of perioperative physical activity on     postoperative pulmonary complications among esophageal cancer patients.   "
4156|NCT03231449|"     FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan     Africa.   "
5733|NCT03210857|"     The aim of this study is to demonstrate the effect of the voluntary neck extension in the     occurrence of an increase in the pulsatility index of the right internal carotid artery in     the amateur diver, realizing an apnea of two minutes or more.   "
4157|NCT03231436|"     The study is designed to compare the effectiveness of spinal anesthesia performed with fixed     dose of hyperbaric bupivacaine regardless of patient's height and weight and anesthesia with     the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that     spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined     with opioid is very effective, regardless of parturient's weight and height, provides very     good surgical conditions and assures patient's comfort while the rate of anesthesia - related     complications is similar or less. Therefore, using height-adjusted protocols, although     preferred in some centres, might not be necessary in order to provide good anaesthesia for     cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric     anesthesia settings, as many of cesareans are performed out of hours, giving less room for     mistakes in less experienced hands.      Two groups of parturients undergoing cesarean section are to be compared: anesthetized with     fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen     (control group). Patients are going to be randomized to one of the above groups, two     anesthetists will be involved in anesthetic procedure: anesthetist that looks after the     patient throughout the procedure will be blinded to the dose of anesthetic given     intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased     and all patients will receive the same perioperative care in terms of fluid therapy,     management of possible anesthesia - related complications and postoperative pain control.      Rate of effective spinal anesthetics, defined as adequate block level and no need for     additional intraoperative analgesia has been established as primary outcome measure.     Secondary outcome measures are rate of complications and amount of opioids used     postoperatively. These are going to be statistically compared.   "
4158|NCT03231423|"     Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with     improvements in minimally invasive surgery. Ensuring patient comfort and early return to life     are the criteria that should be given priority in this treatment method. The purpose of this     study is to determine the use of drain, which closely affects these criteria; And the effect     on patient comfort.   "
4159|NCT03231410|"     This study is designed to identify novel predictors of vascular access success or failure in     chronic kidney disease patients. Despite efforts to improve placement of arteriovenous     fistula (AVF) the primary failure rates are reported as high as 20-50%, but standard tools     like ultrasound cannot inform the clinician sufficiently to accurately predict success or     failure.      The aim of this study is to perform enhanced assessments of arterial health preoperatively     and correlate these measurements with vascular lesions (microscopic tissue changes and     monocyte infiltration) and early AVF outcome.      Activation of monocytes in uremia condition is responsible for endothelium dysfunction,     intimal hyperplasia and atherosclerosis. The investigators expect that stiff arteries caused     by monocyte dysfunction refer to the poor distensability and probably longer maturation time.   "
4160|NCT03231397|"     Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or     because they do not have an AAA (control group).      The purpose of this research study is to further study, through FEA, changes that occur in     the mechanical properties of the aortic wall. The investigator will compare two radiotracers,     18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about     inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging     during the PET-CT scan. The investigator will also compare the results describing the     mechanical properties of the AAA wall to the degree of inflammation in that wall as     determined by PET-CT imaging to define new and better predictors of AAA growth and/or     rupture.   "
4161|NCT03231384|"     The purpose of this study is to determine the safety and feasibility of remote limb ischemic     conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.   "
4162|NCT03231371|"     Heart transplantation is a life-sustaining therapy that allows patients with either     congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time,     however, the transplanted heart can develop problems. One of the more common and troubling     problems is the development of stenoses, or narrowings, within the coronary arteries. These     narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account     for the single most common cause of death or need for repeat heart transplant in persons more     than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac     catheterization using coronary angiography (where dye is directly injected into the coronary     blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good     treatment for CAV aside from treatment of symptoms and listing for repeat heart     transplantation. The goal of this study is to test several newer methods of diagnosing CAV.     The first is called coronary flow reserve (catheterization test). The second is called     Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI     test, only for patients 12 and older). The older method (coronary angiography) will still be     used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose     patients with CAV earlier in the course, prior to a patient's development of abnormal     angiograms. If this can be done, it is possible that better therapies will be able to be used     to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the     need for repeat heart transplantation.   "
4163|NCT03231358|"     The purpose of this study is to test the efficacy of Our Family Our Future, an integrated     intervention for preventing HIV and depression onset among adolescents.   "
4164|NCT03231345|"     Difficult venous access in some patients such as those with obesity, IV drug use, chronic     illness, or vascular pathology often causes increased discomfort and delayed patient care due     to multiple attempts to gain venous access. If access is achieved at all, it usually results     in a much smaller catheter than needed to provide optimal care for the patient.     Ultrasound-guided placement of a peripheral IV in the internal jugular vein is common in the     investigators' emergency department and is gaining popularity across the US. This study     investigates the utility and safety of placing an ultrasound-guided peripheral IV catheter in     the internal jugular vein.   "
4165|NCT03231332|"     The aim of this Project is, within the scope of industrial research, to evaluate the long     term effects of H.pylori eradication on microbiome (gut microbiome, upper respiratory tract     microbiome) and lasting adverse events. In addition, the project aims to evaluate its effects     on abundance and prevalence of extended-spectrum beta-lactamases coding genes and develop     cost effective ESBL screening test prototype.   "
4166|NCT03231319|"     To compare the different analgesic protocols for patients receiving total hip     arthroplasty(THA). Patients will divided into 3 groups, which are 1. fascia iliaca     compartment block with IV-PCA(patient controlled analgesia), 2. femoral nerve and lateral     femoral cutaneous nerve block with IV-PCA, 3. IV-PCA only.   "
4281|NCT03229798|"     Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible     dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™     system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.   "
4167|NCT03231306|"     This is a phase II open label study that will evaluate children ≥ 1 year of age and adults     with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK     inhibitor, binimetinib. The primary objective is to determine if there is an adequate level     of disease responsiveness to binimetinib in children and adults with NF1 and inoperable     plexiform neurofibromas. The objective response to binimetinib is defined as ≥ 20% decrease     in tumor volume reduction by 12 courses.   "
4168|NCT03231293|"     This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and     prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All     participants will receive fimasartan, and the investigators will follow them up for 6 months.   "
4169|NCT03231280|"     This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.     Half of the patients will receive the agent via intra-articular injection and half will     receive a placebo injection.   "
4170|NCT03231267|"     This research focuses on antibiotic resistant bacteria that may reside in the digestive tract     (intestinal flora) of everyone.      When we develop an infection, the bacteria in question is, often, already present in our     flora. Face to the growing phenomenon of multi-resistance, which is a public health problem,     it is essential to follow the frequency of these bacteria but also to find new strategies and     effective means to fight against their spread.      It has been discovered long time ago that it exists viruses able of destroying bacteria: they     have been called bacteriophages .They was used before the arrival of antibiotics for the     treatment of various infections (phagotherapy). Today, with the problems of resistance,     phagotherapy could become a good way to fight against infections with bacteria very resistant     but also a way to remove the resistant bacteria that are present in our digestive flora.      Moreover, it is known that these viruses of bacteria are present everywhere in the     environment (waters, soils, human digestive tract and animal), it is important to check their     presence in our digestive tract. Our objective is to study if the presence of these phages     prevents resistant bacteria from set up in our digestive flora.      To answer the question, it is planned to include 460 people hospitalized in intensive care     unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of     resistant bacteria is carried out regularly during the hospitalization. Three resuscitation     services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool     samples collected at different times of the stay (admission and then during the stay), we     will look for 2 types of bacteria and viruses capable of destroying them.   "
4171|NCT03231254|"     Study Objective: To explore the differences in predicted therapeutic outcome of OA and     optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP)     with overnight PSG in Quebec versus Shenyang patients with OSA.      Design: A prospective, inter-ethnic pilot study. Setting: Two Standard sleep disorder     clinical care in Quebec (Canada) and Shenyang (China), with oral appliance titration tests     performed in sleep laboratory.      Participants: Consecutive specific OSA patients, who are potential candidates for treatment     of OSA with an oral appliance (n=100, 50 Canadian, 50 Chinese), will be recruited from a     sleep center or respirologists, psychiatrists, otolaryngologist and dentists practicing with     broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI＜40 kg/m2).      Interventions: A mandibular protrusive titration study in the PSG lab using a RCMP not only     predicts the eventual therapeutic outcome but also prospectively determines Optimal     Protrusive Position (OPP) for participants predicted to be therapeutically successful with OA     therapy. One goal of this study is to identify OA favorable candidates by physicians using     prospectively and explicitly designed criteria. Analyses of the predicted therapeutic outcome     of OA and OPP between the two ethnic populations (patients in Quebec and Shenyang) will be     processed after matching for OSA severity.   "
4172|NCT03231241|"     Study is aimed at determining why some patients with episodic headache proceed to chronic     daily or near daily headaches. The Investigators seek to discover differences in brain     anatomy and function, composition of cerebrospinal fluid, blood products, genetics, and     patient phenotypes that might help explain this process.   "
4173|NCT03231228|"     This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of     cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive)     scheduled for surgery.   "
4174|NCT03231215|"     The purpose of this study was to evaluate the efficacy of dexamethasone when added to     epidural bupivacaine on the duration of postoperative analgesia in patients underwent total     knee replacement surgery.   "
4175|NCT03231202|"     The primary objective is to compare the failure rate due to splenic bleeding between the     patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative     management (NOM) and the patients not undergoing SAE. We hypothesize that the use of     pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.   "
4176|NCT03231189|"     When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as     rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is     performed. In this situation, the investigators aim to evaluate a strategy with CMR as the     front line exam, and invasive coronary angiography performed only in case of ischemic scar on     CMR   "
4177|NCT03231176|"     This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer.     Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive     inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal     growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer     by simultaneous inhibition of these receptors. The purpose of this study is to determine the     safety and efficacy of Varlitinib in combination with capecitabine for the treatment of     Biliary Tract Cancer. Eligible patients will receive Varlitinib plus capecitabine.   "
4178|NCT03231163|"     The objective of the study is to determine whether music has any effect on resting metabolic     rate (RMR), which is the amount of energy expended at rest. There is currently conflicting     research on how music affects RMR. One problem with RMR testing is that participants often     fall asleep during the test. There can be a 5-10% difference in the metabolic rate between     rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a     potential strategy to prevent participants from falling asleep. Participants will undergo RMR     measurements while listening to no music, relaxing classical music, and self-selected     classical music.   "
4179|NCT03231150|"     The primary aim of this clinical experiment is to compare, in terms of pain relief measured     using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of     ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of     corticosteroid for the treatment of proximal PF. Secondary aims will be to compare     foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol     Foot Score (BFS), between the injection groups, and also to compare the pre-injection to     late-term post-injection thickness of the plantar fascia as measured in the nested USGI     group.   "
4180|NCT03231137|"     This study was conducted to compare post-extraction augmented sockets using Atorvastatin     loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct     application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and     spontaneously healed socket (Control) both clinically and by histomorphometric analysis of     formed bone quality.   "
4181|NCT03231124|"     This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO     32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary     objective is the assessment of PK in Japanese subjects.      Data obtained from this trial will be used to compare with existing data from the other Phase     1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects     will allow the inclusion of Japanese patients into Phase 2b studies.   "
4182|NCT03231111|"     The Effectiveness of Using Preventive Multimedia Teaching Program in Lung Cancer Women     Receiving Targeted Therapy on Skin-Related Quality of Life   "
4183|NCT03231098|"     The objective of this study is to investigate the use of patient throat gargle as an     alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic     Streptococcus (GABHS) infection, also known as strep throat.   "
4184|NCT03231085|"     Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries     in children and especially in the surgery of craniosynostosis. The bioavailability of oral     iron is low and compliance with treatment is inconsistent. The aim of this study is to     evaluate whether the use of ferric carboxymaltose by injection, which has a much better     bioavailability, would make it possible to increase the preoperative hemoglobin level more     effectively and thus reduce the risk of perioperative blood transfusion .   "
4185|NCT03231072|"     Evacuation of pleural effusion (PE) represents a disputable therapy in mechanically     ventilated patients. Patients on mechanical ventilation indicated by the physician to pleural     fluid evacuation will be monitored throughout the procedure by electrical impedance     tomography (EIT) and concurrently end-expiratory lung volume (EELV) will be measured in order     to describe impact of PE evacuation on aeration and ventilation of the lungs.   "
4186|NCT03231059|"     The GLOBAL LEADERS Adjudication Sub-StudY, GLASSY, is based on a re-assessment of all the     events reported in the dataset of the parent trial (COMPARATIVE EFFECTIVENESS OF 1 MONTH OF     TICAGRELOR PLUS ASPIRIN FOLLOWED BY TICAGRELOR MONOTHERAPY VERSUS A CURRENT-DAY INTENSIVE     DUAL ANTIPLATELET THERAPY IN ALL-COMERS PATIENTS UNDERGOING PERCUTANEOUS CORONARY     INTERVENTION WITH BIVALIRUDIN AND BIOMATRIX FAMILY DRUG-ELUTING STENT USE) by an independent     Clinical Event Committee (CEC), composed of three physicians not involved in the main trial.     The substudy include the first 19 top-enrolling sites of the GLOBAL LEADERS to reach the     estimated sample size of 7,186 patients for the two co-primary outcomes of death, any     non-fatal myocardial infarction, any non-fatal stroke or urgent target vessel     revascularization and bleeding events classified as 3 or 5 according to the Bleeding Academic     Research Consortium (BARC) criteria. To ensure a comprehensive assessment of clinical events,     a triggers logic is adopted to identify other potential events qualifying for study endpoints     but not reported as such by local investigators.   "
4187|NCT03231046|"     The objective of this research is to evaluate functional validation of the CBCT-US fusion for     the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system     performance.   "
4188|NCT03231033|"     Pulmonary alveolar proteinosis (PAP) is a syndrome of surfactant accumulation, respiratory     failure, and innate immune deficiency for which therapy remains limited to whole lung lavage     (WLL), an invasive physical procedure to remove surfactant unavailable at most medical     centers. While PAP occurs in multiple diseases affecting men, women, and children of all ages     and ethnic origins, in 85% of patients, it occurs as an idiopathic disease associated with     neutralizing GM-CSF autoantibodies. Basic science and translational research has shown that     idiopathic PAP is an autoimmune disease in which disruption of GM-CSF signaling impairs the     ability of alveolar macrophages to clear surfactant and perform host defense functions.      Recently, it has been shown that cholesterol toxicity drives pathogenesis in alveolar     macrophages from GM-CSF deficient (Csf2-/-) mice and patients with autoimmune PAP. Loss of     GM-CSF signaling reduces PU.1/CEBP-mediated expression of PPARγ and its downstream target     ABCG1 (a cholesterol exporter important in macrophages). The cell responds by esterifying and     storing cholesterol in vesicles to reduce toxicity. Eventually, vesicles fill the cell,     impair intracellular transport and reduce uptake and clearance of surfactant from the lung     surface resulting in disease manifestations. Recent data indicates that pioglitazone, a PPARγ     agonist currently approved by the FDA for human use, increases cholesterol/surfactant     clearance by alveolar macrophages from autoimmune PAP patients and Csf2-/- mice. Importantly,     pioglitazone significantly reduced the severity of PAP lung disease in Csf2-/- mice after     several months of therapy. Together, these observations suggest pioglitazone could be     'repurposed' as pharmacologic therapy for PAP.   "
4189|NCT03231020|"     The purpose of this study is to provide a rich description of the parental perspectives of     utilizing a mHealth application for data transfer during the single ventricle interstage     monitoring period. A gap in the body of knowledge of single ventricle cardiac disease     interstage will be explored with these research questions: 1) How do parents of children (< 5     years of age) with single ventricle disease describe their experiences using a mHealth     application during the interstage period (first 6-12 months of child's life)? And 2) How do     these experiences influence their decision making for use of the mHealth application?   "
4282|NCT03229785|"     This study aims to look at whether human umbilical cord blood plasma (HUCBP) is safe for     intravascular (iv) administration; and whether it provides any reversal of frailty or other     age-related biological measures.   "
19648|NCT03028389|"     To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the     incidence of delirium in elderly patients after non-cardiac surgery.   "
4190|NCT03231007|"     The study is a multicentre evaluation of maternity care delivered through the Saving Babies'     Lives care bundle using both quantitative and qualitative methodologies. The study will be     conducted in twenty NHS Hospital Trusts from six NHS Strategic Clinical Networks totalling     approximately 100,000 births. It involves participation by both service users and care     providers.      To determine the impact of the care bundle on pregnancy outcomes, birth data and other     clinical measures will be extracted from maternity databases and case-note audit from before     and after implementation. Additionally, this study will employ questionnaires with     organisational leads and review clinical guidelines to assess how resources, leadership and     governance may affect implementation in diverse hospital settings. The cost of implementing     the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a     health economic analysis. The views and experiences of service users and service providers     towards maternity care in relation to the care bundle will be also be sought using     questionnaires.      This study will provide practice-based evidence to advance knowledge about the processes that     underpin successful implementation of the care bundle so that it can be further developed and     refined. This has the potential to translate into substantial improvements in the rate of     late stillbirth in the UK should the care bundle be proved effective.   "
4191|NCT03230994|"     To set up a Cooperative Network by enrolling 5000 patients with Adenomyosis(AM) from multiple     centers.Based on the Network platform and Database,the investigators try to explore the     diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In     addiction，the investigators expect to conduct research on the effect and the follow-up     fertility outcomes of different medical or surgical treatment, the etiology of AM and     endometriosis,the perspective investigation of the malignant transformation of AM ;the     high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical     Guidelines about AM which suitable to chinese conditions.   "
4192|NCT03230981|"     The aim of this pilot study is to assess the ability of a new optical coherence tomography     system to obtain information on biomechanics of the cornea.   "
4193|NCT03230968|"     Background. Mexico is lacking guidelines that provide an integral approach for the prevention     and control of respiratory diseases in adults. The World Health Organization (WHO) proposed a     Practical Approach to Lung Health (PAL) using generic guidelines to be used in primary     health care settings for diagnosis and treatment of respiratory diseases. These guidelines     were adapted to the Mexican context as AIRE campaign by the Instituto Nacional de     Enfermedades Respiratorias, Mexico. Objective. To evaluate the feasibility and effectiveness     of implementing a model of care for respiratory diseases in adults based on AIRE guidelines,.     Materials and methods. Prospective quasi-experimental pre-post study. During 03-08/2013     (phase 1), investigators recruited consenting subjects older than 15 years of age seeking     medical care in primary care centers in Orizaba, Veracruz. Researchers investigated     sociodemographic, epidemiological and clinical information before consultation. On patients     who had been diagnosed with respiratory disease by a physician, researchers investigated     prescribed treatment on leaving the physician´s office. A month later conducted a home visit     to investigate clinical outcome. During 09/2014 we trained doctors from the participating     health centers in AIRE guidelines. From 10/2014 to 03/2015 (phase 2) researchers again     surveyed all consenting subjects older than 15 years of age who received health services in     the same health centers following the same procedures as in phase 1.   "
4194|NCT03230955|"     Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group     (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance     to quit smoking (including psychological and psycho-educational support and pharmacological     treatment advice, if required) proactively for 12 months, and the CG only brief counselling     after discharge.      To assess the effectiveness of a multicomponent and motivational intensive telephone-based     intervention to stop smoking (quit line) addressed to smokers with mental disorders     discharged from hospitals.   "
4195|NCT03230942|"     This study aims to evaluate the effect of preoperative patient education program on     functional mobility, gait, postural control, and kinesiophobia level in subjects with TKA.     Patients of both gender will be recruited unilaterally in the city of Florianopolis and     referred by an orthopedist to the Physiotherapy Clinic of UDESC. They are divided into two     groups: one that will receive verbal guidance and a booklet with related information such as     your physical condition as well as signs and symptoms in the postoperative period and a group     that will receive only verbal guidance.Both groups will be evaluated by a blind evaluator in     the preoperative and postoperative periods (6 weeks and 6 months). The evaluations will be     divided into five stages. Anthropometric measurements of the individual will be made and then     the WOMAC functionality questionnaire and the Kinesiophobia Cover Scale will be applied.Then     the individual will walk for 5 meters for three-dimensional gait analysis and     electromyographic analysis of the quadriceps and femoral biceps. The evaluation of functional     mobility by Timed Up And Go and assessment of postural control in an equilibrium platform     will also be performed. Statistical data will be analyzed by analysis of variance 3x2     considering factor time (pre, post 6 weeks and post 6 months) and groups (with and without     information leaflet). The value of p will be 0.05.   "
4217|NCT03230630|"     Pre-clinical and clinical studies have demonstrated that melatonin has cardio-protection     effects. Melatonin has anti-inflammatory, antioxidant, antihypertensive, antithrombotic and     antilipaemic properties, which plays important roles in a variety of cardiovascular     pathophysiologic processes. Nocturnal melatonin levels decreased after AMI, and lower serum     melatonin concentrations after AMI are associated with more heart failure and cardiac death     and left ventricular remodeling. Moreover in women with increased BMI, lower melatonin     secretion is associated with higher risks of MI. Early-morning blood collection is easier in     clinical practice. Therefore, the investigators carried out a cohort study to evaluate the     prognostic value of plasma soluble melatonin in hospitalized patients with acute myocardial     infarction (AMI).   "
4421|NCT03227965|"     Cancer is a well known complication about long term transplantation. Cancer outcomes are due     to the immunosuppressive treatment that prevents transplanted people from rejection. By     lowering the effectiveness of the immune system, immune cells are no longer able to seek and     destroy cancer cells.      The goal here is to study immunes cells population of people that were transplanted 10 years     ago and are now treated either by a corticosteroid - azathioprine association, or only by     cyclosporine A.   "
4196|NCT03230929|"     Currently, a lot of equipments based on Bispectral index (BIS) is used clinically in order to     measure the depth of anesthesia. Although BIS is used for the measurement of the presence of     consciousness or degree of sedation during general anesthesia, it could be influenced by     factors that affect or interfere with the activity of EEG because it is a numerical value     which is measured by analyzing EEG. The BIS electrode for EEG analysis should be attached to     the patient's forehead and the EEG signal is 0.5 - 30 Hz, the EMG signal is 30 - 300 Hz, and     the BIS analyzes the 0 - 47 Hz signal. Therefore, 30 -47 Hz EMG signal may influence the BIS     value and the BIS value may differ from the actual. In patients with complete muscle     relaxation, the change in BIS varies in proportion to the concentration of anesthetic, but in     a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle     relaxation occurs, BIS value may not accurately reflects the change in the depth of     anesthesia. Although there is a study on the influence of the degree of muscle relaxation on     BIS value, there is no study on whether phase lag entropy (PLE) measuring anesthesia depth     based on different mechanism from BIS is affected by status of muscle relaxation. After     measuring BIS and PLE at the same time, I will compare both of them and investigate the     reliability of the measurement of the depth of anesthesia of PLE and how electromyogram     activity affects PLE.   "
4198|NCT03230903|"     The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated     Telemanagement) System as an adjunct to the current standard of medical care for patients     with MS (PwMS). The individual patient with MS will be the unit of analysis. For each     participant, the investigators will assess the effect of Home Automated Telemanagement (HAT)     on functional outcomes, levels of disablement including impairment, activity and     participation, socio-behavioral parameters, and satisfaction with medical care as described     below.   "
4199|NCT03230890|"     The purpose of this study is to evaluate the effects associated with the use of in-office     High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) for     participants with symptoms of military-related traumatic stress. This is a single site,     non-randomized, open label pilot study. Outcome measures collected before, and after the     intervention evaluate effects on self-reported symptoms, autonomic cardiovascular regulation,     functional measures, blood and saliva biomarkers of stress and inflammation, and network     connectivity on whole brain, rest MRI testing. Self-reported symptom outcomes will also be     collected remotely at 1, 3, and 6 months after completion of intervention. The study will     assess feasibility in this cohort, focused on the Special Operations community, will provide     estimates of effect size, and durability of symptom changes, while providing important pilot     data for future proposals and investigations.   "
4200|NCT03230864|"     This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in     patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia     (TRS)   "
4201|NCT03230851|"     A total of 210 coronary atherosclerosis patients without indications for stent implantation     are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and     urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA     after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1:     aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning     50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg     bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and     urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach     Intestinal reactions, small bleeding events are recorded.   "
4202|NCT03230838|"     This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)     compared with that of meropenem in pediatric participants with cUTI, including     pyelonephritis.   "
4203|NCT03230825|"     We speculate that the use of combined oral contraceptives may be a possible solution to     promote the management of retained pregnancy products versus expectant management. By     withdrawing the pill, the endometrium is expected to shed in a synchronized fashion (estrogen     and progestin withdrawal bleeding and may also shed the retained products of conception and     avoid a surgical procedure with its related potential complications.   "
4204|NCT03230812|"     the results from animal studies and preliminary human studies show that carnitine     availability and acetylcarnitine concentrations are low in insulin resistant states such as     with type 2 diabetes mellitus. However, in humans, carnitine supplementation is sometimes     beneficial, but not in everyone. We hypothesize that this variability in response is due to     differences between individuals in the amount of carnitine in the muscle i.e. only subjects     with a low initial carnitine status will benefit from supplementation. The state of the art     non-invasive magnetic resonance spectroscopy method allows us to identify patients with low     vs high muscle acetylcarnitine status. Here we aim to - for the first time - make the     translational step to humans and test the hypothesis that carnitine supplementation in type 2     diabetic patients with initially low carnitine status enhances metabolic flexibility and     insulin sensitivity to a greater extent than in subjects with an initially high carnitine     status.   "
4205|NCT03230799|"     In this study, the investigators give participants who had a lens implantation before a     secondary intraocular lens implantation in the purpose of reduce complications of surgeries     for dense cataract , and report a prospective, non-randomized controlled study aiming at     comparison of minimal invasive lens surgery and traditional cataract surgery for treating     congenital cataracts   "
4206|NCT03230786|"     This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II     trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type     2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of     metformin.      The trial is planned to be performed in Czech Republic, Denmark, Poland, Romania and United     Kingdom   "
4283|NCT03229772|"     The primary purpose of the study is to obtain sample clinical images that are evaluated by     physicians in support of regulatory submissions. Additionally, the study will provide data     for current and future product development and it will provide clinical images and data for     marketing use.   "
4422|NCT03227952|"     The purpose of this study is to investigate the effectiveness of low-intensity and prolonged     vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.   "
4208|NCT03230760|"     Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the     common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion     and pressure exerted by the synthesis and storage of breast milk and it usually happens when     the breasts switch from colostrums to mature milk. However, engorgement can also happen if     lactating women miss several nursing and not enough milk is expressed from the breasts. It     can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may     lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a     plugged duct.      According the meridian theory, the investigators propose the acupuncture treatment for     patients of breast engorgement.      The investigators will include 60 patients and measure the acupuncture effect. The inclusion     criteria are women with breast engorgement and 20 years old or older. Exclusion standards are     patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38     degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound     therapy applied   "
4209|NCT03230734|"     Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus     prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC)      Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic     castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms:        -  Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of          progression (the second step is optional according to clinical evolution of disease)        -  Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of          progression (the second step is optional according to clinical evolution of disease).   "
4210|NCT03230721|"     Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice     for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands     (>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes     and safety of different techniques of endoscopic enucleation of the prostate (monopolar     enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.   "
4211|NCT03230708|"     This study makes an observation over the objective response rate of autologous erythrocytes     derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy     combination in the treatment of malignant ascites. All the participants will randomly receive     the treatment of autologous erythrocytes derived microparticles packaging methotrexate     peritoneal perfusion and systemic therapy combination or convention drugs peritoneal     perfusion and systemic therapy combination.   "
4212|NCT03230695|"     Stroke is the second cause of death worldwide and the majority of the survivors remain with     motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as     a potential intervention to enhance effects of other rehabilitation strategies on improvement     of motor performance of the paretic upper limb. In this proof-of-concept study we will     evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere     associated with robotic therapy on improvement of motor performance of the paretic upper limb     in the early phase post-stroke.   "
4213|NCT03230682|"     Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale     (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can     arguably predict the remission at the 12th week. Our observation study including 80 MDD     patients will access resting-state function MRI to finding factors which infuencing early     improvemrnt, respone and remission of antidepressants.   "
4214|NCT03230669|"     Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) is a new on-line     addiction treatment developed by Dr Kathleen Carroll at the Yale School of Medicine in New     Haven, Connecticut. CBT4CBT consists of seven one-hour long online sessions that teach key     concepts, including dealing with cravings, problem solving, and decision making skills, to     help users reduce substance abuse. CBT4CBT has been rigorously tested throughout various     communities in the United States with great success and is currently being rolled out     throughout the States. The therapeutic approach of CBT4CBT is unique as its efficacy,     durability and cost-savings have been proven in several rigorous clinical trials and will be     magnified by the fact that the program can be delivered in Canada, allowing for increased and     continual improvements in population health. CBT4CBT has been accepted by both patients and     addiction treatment personnel alike and has won numerous clinical innovation awards.      A collaboration has now been formed between Dr Carroll and Drs Michelle Patterson and Juergen     Krause of the UPEI Centre for Health and Community Research (CHCR) that will bring CBT4CBT to     Canada. While CBT4CBT has previously been tested in urban areas, there are many advantages to     offering computer-based training to more rural populations (such as PEI). These more remote     areas frequently suffer from a lack of services, as well as a lack of continuity with the     services currently offered. CBT4CBT may very well provide that needed continuity to     Addictions treatment and has also been shown to improve retention.   "
4215|NCT03230656|"     Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury     (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems     identified by these patients include difficulty with memory, multi-tasking, the ability to     complete tasks quickly, and higher executive functions (e.g., inhibition, initiation,     insight, motivation) (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012,     Rabinowitz & Levin, 2014). If these symptoms persist they can not only affect thinking, but     also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing)     (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both     thinking and communication can better identify individuals at-risk for persistent symptoms at     two week and four weeks post-injury. Also, if cognitive-communication therapy was     administered earlier post-injury, then outcomes related to return to daily activities, work,     and/or the academic setting could possibly change. This study intends to investigate the use     of cognitive and communication screening measures for the identification of persistent     symptoms and the provision of early cognitive-communication therapy if problems persist.   "
4216|NCT03230643|"     The objective of this single center prospective clinical trial is to evaluate the safety and     efficacy of carotid Baroreflex Activation Therapy (BAT) in advanced heart failure (HFrEF).     Beyond that, the primary aim of this study is to identify patients of the whole HFrEF     population that are most likely to benefit from this new promising therapy.   "
4218|NCT03230617|"     Chronic obstructive pulmonary disease is a common respiratory condition that is characterized     by inflammation of the large and small peripheral airways , the alveoli and adjacent     capillary networks. Severe airflow obstruction that imposes a significant load on the     respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The     reduced expiratory airflow also causes air trapping at the end of expiration , producing     alveolar pressure that are higher than atmospheric pressure before the next breath. This     condition is intrinsic positive end-expiratory pressure .   "
4219|NCT03230604|"     To minimize the effects of polymerization shrinkage in the restorative treatment, there are     new composites called Bulk- Fill which the companies has developed this composites for     example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization     shrinkage and properties allow the material to be inserted in one layer being quickly than     traditional composite. This clinical study is designed to compare the clinical performance of     the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior)     and V (cervical-surface posterior) fillings.   "
4220|NCT03230591|"     Study Design: This is an observational study. No treatment or intervention will be assigned     to the subjects. All patients will receive full standard of care concomitant medication for     the treatment of their cardiac condition. 25 patients with genetically confirmed     Anderson-Fabry disease who have a plan to start ERT with Agalsidase Alfa will undergo 2D     strain, diastolic stress echocardiography, LV vortex flow analysis, and CMR at baseline and     after 1 year of treatment with ERT with Agalsidase Alfa for follow-up.   "
4221|NCT03230578|"     The goal of this study is to identify the thoughts and perceptions of pharmacy access to     hormonal contraception among rural women and pharmacists. This will be key in order to     address concerns or perceived barriers in order to inform the implementation of this program.   "
4222|NCT03230565|"     To compare continuous infusions to bolus infusions and there affect on post-surgical pain.   "
4223|NCT03230552|"     There is a need for the development and validation of new teaching strategies and resources     for surgical training that can occur outside of the operating room. The use of surgical     videos is not novel however it has not been validated as an effective approach for     gynecologic surgical training. The goals of our study are to (1) develop an educational     surgical video for laparoscopic salpingo-oophrectomy (LSO) and (2) to evaluate and test the     effectiveness of this tool in preparing residents for performance in the operating room.   "
4224|NCT03230539|"     The UPA doses to be tested in this new IUS, 5, 20 or 40 μg per day, are not expected to     suppress ovulation, however they should prevent endometrial growth resulting in endometrial     atrophy, minimal bleeding, or even amenorrhea. It is anticipated that with low UPA doses,     women will continue to ovulate and secrete progesterone (P) during the secretory phase of the     menstrual cycle. As a result, PRM associated endometrial changes (PAECs) that have been     described in previous UPA studies when ovulation was suppressed and associated with     amenorrhea should not occur and endometria should retain normalcy. These expectations are     based on our findings from a previous study in which the UPA doses tested were insufficient     to block ovulation and participants maintained P secretion with normal endometria (protocol     349). Further evidence regarding the benefit of using low doses of UPA in a copper IUS stems     from a small rhesus macaque proof of principle study that included an UPA-IUS delivering 40     or 60 μg/d of UPA, and fixed doses of E2 and cyclic P delivered via implants over 3 cycles.24     Indices of endometrial proliferation were significantly reduced in 3 out of 5 animals in that     study; the endometria were atrophied with some glandular cysts, and typical PAECs were     limited. Glands were generally small and tubular, however, in some animals they were large     and dilated; resembling cysts with minimal evidence of proliferative activity.24 No bleeding     was observed in the treated monkeys during progesterone withdrawal over the 3 cycles.   "
4225|NCT03230526|"     Phase II, Open-labeled, Prospective, Multi-center study of assessing the link between     microglial activation and dopaminergic denervation kinetics in the early stage of Parkinson     disease, by using the imaging of [18F]DPA-714 a new ligand of Translocator Protein-18 kDa     (TSPO) by Positron Emission Tomography (PET).   "
4226|NCT03230513|"     Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults     and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to     compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and     Brandt-Daroff exercise (BDE) in patients with posterior canal BPPV based on vertigo     resolution, reduction of vertigo intensity, the Dizziness Handicap Inventory scores and the     conversion of a positive to negative Dix-Hallpike test.   "
4227|NCT03230500|"     Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone     will be recruited to the study. After extraction of the tooth implant will be placed     immediately, implants will be placed either by free hand or computer guided technique.     patient satisfaction will be evaluated as primary outcome and early implant failure will be     evaluated as secondary outcome.   "
4228|NCT03230487|"     Part 1 (SRD (Single-rising dose)):      The primary objective of this trial part is to investigate the safety and tolerability of BI     1015550 in healthy male subjects following oral administration of single rising doses.      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single     dosing.      Part 2 (MRD (Multiple-rising dose)):      In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550     in healthy male subjects following oral administration of multiple rising doses.      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple     dosing.   "
4229|NCT03230474|"     I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis,     nausea/emesis, constipation, urinary retention, respiratory depression and undesirable     sedation) so using it as additive to intrathecal morphine in patients undergoing anal     surgeries under spinal anesthesia may be beneficail   "
4230|NCT03230461|"     Optimal chest compression depth during CPR is 4.56cm which is at variance with the current     guidelines of 5.0-6.0cm. A change in guidelines is only worthwhile if healthcare     professionals can accurately judge a subtle reduction in chest compression depth during CPR     by a relatively small amount.   "
4284|NCT03229759|"     Healthy volunteers will receive treatment to two body locations with the investigational     product and placebo and the antimicrobial effectiveness of each treatment will be measured.   "
4232|NCT03230435|"     Eating disorders (ED) comprise a multitude of symptoms involving a disturbed body image and a     preoccupation with food or bodyweight. EDs are often difficult to treat, in part due to the     lack of motivation for improvement. Anorexia nervosa (AN) has the highest mortality rate of     any psychiatric disease, and less than half of patients will recover from the disease.     Studies have found that patients suffering from AN have impaired health-related quality of     life (HRQoL) compared to the general population. It has also been suggested that despite     improvement in clinical parameters, patients report deterioration in HRQoL, which is in line     with a study finding low agreement between patient perceived outcome and clinician assessed     characteristics. To evaluate the patients' perception of their disease, it is important to     develop reliable and valid assessment tools. Previously generic questionnaires have been used     to assess HRQoL in Danish ED patients, as no disease-specific questionnaires have been     developed. Translating and validating a disease-specific questionnaire would provide a useful     tool in assessing current treatment and in developing new treatment options. This study aimed     to develop a Danish version of an internationally disease-specific HRQoL questionnaire.     Furthermore, HRQoL is assessed in patients who have gone through shorter or longer treatment.   "
4233|NCT03230422|"     In Pediatric both manikin and human studies have suggested that the video laryngoscopy is     equally suitable to facilitate intubation compared to the direct laryngoscopy.   "
4234|NCT03230409|"     This study evaluates the efficacy of nursing interventions on adherence to antituberculosis     medication in a paediatric cohort (aged 0-18 years) and identifies the risk factors for     non-compliance.      There are two phases in the study; Phase 1: retrospective descriptive analysis in children     and young people receiving antituberculosis treatment (non-intervention group); and Phase 2:     quasi-experimental, longitudinal, prospective study (intervention group). The results of the     two phases will be compared.   "
4235|NCT03230396|"     The present study will investigate the oral release and systemic pharmacokinetics of a panel     water- and fat-soluble vitamins from two commercially-produced chewing gum formulations.     Vitaball, Inc. (Ft. Thomas, KY) markets a line of vitamin-fortified gums. These products     include Vitamingum Sport and Vitamingum Fresh, which are marketed to different consumer     populations. There is currently no available data on the release of vitamins from these     products in the oral cavity or the impact of chewing these products on plasma levels of the     component vitamins following acute administration. The investigators hypothesize that these     chewing gum products will increase both salivary and plasma levels of the component vitamins.     The present study has two major objectives:        1. To determine the extent to which a subset of water-soluble and fat-soluble vitamins in          two different Vitamingum products are released from the gum matrix and into the saliva          as healthy human subjects chew the gum.        2. To determine the extent to which chewing Vitamingum can acutely influence plasma levels          of a subset of water-soluble and fat-soluble vitamins in a population of healthy human          subjects.      The test articles are commercially-marketed products and are currently available to     participants outside the study (http://chewvitamingum.com). The present study is not intended     to develop a treatment for a particular disease, but rather to determine if the vitamin     components of these commercially-produced chewing gum products are bioaccessible or     bioavailable. Vitamin supplements administered as tablets, capsules, caplets, or gummies     might be regarded as the standard of care.   "
4236|NCT03230383|"     This will be an investigator- and subject-blinded (sponsor open), randomized, placebo     controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional     sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts),     and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each     cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10     subjects dosed in each cohort.      For a given subject in any cohort, the total study duration from screening to follow-up phone     call will be between approximately 7 to 11 weeks.   "
4237|NCT03230370|"     Study purpose This study will explore whether an additional rehabilitation program that focus     on either upper or lower extremity training facilitate the recovery in upper or lower     extremity.      The recovery in both neurological status and motor functions will be explored.   "
4238|NCT03230357|"     This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved,     carry out the guidance of EDUG PICC standardized operation at the same period. Each center     assists to use app to collect research data.The experimental data will be collected,     processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG     will be evaluated according to the results (like the rate of once in place, the number of     adjustment times before X-ray, the length of time during the whole catheter placement, the     ectopic incidence during PICC first implantation and so on, the special content can be seen     in the next indicator section)   "
4239|NCT03230344|"     The aim of this study is to evaluate the periodontal parameters in terms of periodontal     healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in     management of concurrent endodontic -periodontal lesion without communication   "
4240|NCT03230331|"     This study aims to evaluate the long term effect of deep brain stimulation in the the     subthalamic nucleus (STN) in patients with Parkinson's disease.   "
4241|NCT03230318|"     This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of ARQ 087     by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects     with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2     gene fusions (by FISH performed by the central laboratory) and who received at least one     prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of     ARQ 087 capsules.   "
4285|NCT03229746|"     Hydroxychloroquine has been reported to have a clinically significant effect on the platelet     count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator     effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease     characterized by transient or persistent decrease of the platelet count. However, refractory     ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly     understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment     of ITP in comparison to other lines of treatment as detected by the standardized definitions.   "
19747|NCT03027076|"     This research is being done to learn more about the bacteria that live in the genito-urinary     tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).   "
4242|NCT03230305|"     The transposition of the results of biomedical research to medical management of patients in     real-life setting depends highly from patient's selection. In Europe and the United States,     the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012     were after 70 years or 158,722 in absolute value. In this context, the median age at     diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also     characterized by the importance of biomedical research devoted to it. Despite the dynamism of     the research activity in oncology and therefore the number of affected patients, the elderly     are paradoxically sparsely included in clinical trials. Numerous studies have focused in     recent years, to identify possible causes of under-representation of elderly patients in     clinical trials but most of them focused on eligibility criteria and few on barriers related     to non-invitation or non-inclusion in eligible patients.      We postulate that a qualitative survey based on an structured epidemiological device will     able to objective evidences of reasons related to the patient, his/her familial caregivers,     his/her physician and the clinical center organization for participating or not to a clinical     trial and the interrelations between the identified reasons.      The main objective is to assess reasons of non-participation of older patients with cancer in     clinical trials, from the physicians, patients and family caregivers' perspectives using     qualitative and quantitative methods.      The secondary objectives are:      To investigate the social representation and construction of being aged from the patient,     physician and family caregiver perspective (qualitative part).      To compare the reasons of non-participation regarding age class (old and very old), localized     versus metastatic disease and tumor site (quantitative part).      To characterize the profiles of participants and non-participants to clinical trial among     older patients with cancer thanks to qualitative and quantitative data.      Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that     includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in     French hospitals.   "
4243|NCT03230292|"     This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.   "
4244|NCT03230279|"     Patients diagnosed with chronic SIJ pain that can be treated by sacroiliac joint fusion or     radiofrequency ablation. The radio frequency ablation is performed using either conventional     or cooled techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. Minimally     invasive sacroiliac joint consists of implanting 2 to 3 metallic implants inside the SIJ to     increase the stability and eventually fuse the SIJ. This randomized controlled trial aims at     comparing treatment success at 6-month follow-up time-point after minimally invasive     sacroiliac joint fusion and radiofrequency ablation for chronic SIJ dysfunction.   "
4245|NCT03230266|"     During this study, the investigators will perform a collection of biological and device     samples (blood, catheters, insulin) in order to investigate the causes of catheter     obstructions in patients with type 1 diabetes treated by implanted insulin pumps using     intra-peritoneal delivery.      This multi-centre study is interventional with minimal constraints. After an inclusion visit,     blood samples and an insulin sample from pump reservoir will be collected. During the     following year, if a peritoneal catheter is blocked or changed, the explanted catheter and     new blood and insulin samples will be collected for examination of the catheter obstruction     and search for patient- or insulin-related reasons for obstructions.      In this study, 140 patients will be investigated.   "
4246|NCT03230253|"     The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain     plasticity, physiological biomarkers and behavioral outcomes, including cognitive and     physical functions, from pre- to post-training; (2) understand the neural mechanisms of     cognitive recovery following two hybrid interventions using the functional magnetic resonance     imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to     identify the correlations between brain activity, biomarkers and behavioral measures.   "
4247|NCT03230240|"     To ascertain immunologic profile of peritoneal cavity and its relationship to immediate     postsurgical outcome (morbidity or the treatment) and long-term outcome (time to recurrence     and survival).   "
4248|NCT03230227|"     Effective pain relief after cardiac surgery has assumed importance with the introduction of     fast track discharge protocols that requires early weaning from mechanical ventilation.     Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of     atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound     has shown to improve early postoperative pain in various surgical procedures.      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in     animal and human models of pain.   "
4249|NCT03230214|"     The present study is to demonstrate the effect of the presence of bacterial translocation     detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the     polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a     liver transplant procedure.   "
4250|NCT03230201|"     This clinical trial is designed to evaluate the role of lymph node dissection in the     prevention of recurrence and metastasis after radical nephroureterectomy for high-risk     primary upper tract urothelial carcinoma (UTUC) patients.   "
4251|NCT03230188|"     The overall purpose of the study is to compare the patterns of neurocircuitry activation in     severe asthmatics vs. mild to moderate and healthy controls. The Investigators hypothesize     that neurocircuitry activation increases with asthma severity, producing different     neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or     non-asthmatics.   "
4252|NCT03230175|"     It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to     the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management     of infection, result in a higher proportion of wounds showing complete healing within 16     weeks of initiating therapy.   "
4253|NCT03230162|"     comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due     to placental insufficiency   "
4254|NCT03230149|"     FD is pan-ethnic. Its reported annual incidence of 1 in 100,000 may underestimate the true     prevalence of the disease. Indeed, recently, in addition with affected males FD developing a     classic phenotype,  cardiac variant  and  renal variant  have been reported for FD     patients with predominant or exclusive cardiac or renal involvement.  Neurologic variant      could exist.      Nervous system can be affect by FD leading to cerebrovascular diseases (ischemic or     haemorrhagic strokes, TIA (Transient Ischemic Attacks) or peripheral neuropathy     (acroparesthesias and pain).      Aims will be to determine the prevalence of Fabry disease in patients with stroke or small     fiber neuropathy, and their characteristics   "
4255|NCT03230136|"     This trial investigates whether a multimodal cardioprotection per-surgery therapeutic     strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to     traditional management. The primary endpoint is the AUC (area under the curve) of the     hypersensitive troponin I. Blood samples will be collected during the 72 hours following the     aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and     controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.   "
4256|NCT03230123|"     Costa ES, Izar MC, Fonseca FAH, França C, Tria H. The benefits of green banana biomass     consumption in patients with diabetes mellitus. Federal University of São Paulo, São Paulo,     2015.      According to the Guidelines of the Brazilian Society of Diabetes, Diabetes Mellitus (DM) is a     heterogeneous group of metabolic disorders associated with microvascular complications,     hyperglycemia, resulting in a higher risk of developing cardiovascular disease. Currently, it     is estimated that the world population with diabetes is 382 million people and it is expected     to reach 471 million in 2035. About 80% of individuals with diabetes live in developing     countries where the epidemic has greater intensity. In the Diabetes Control and Complications     Trial and UK Prospective Diabetes Study demonstrated that intensive glycemic control (HbA1c ~     7.0%) reduces chronic microvascular complications. The resistant starch (RS) is defined as     starch and products of its hydrolysis are not absorbed in the small intestine. The green     banana presents significant levels of RS, and it is considered a source for the intake of     this substance. These foods have physiological functions in the intestinal regulation in     glycemic control and delayed gastric emptying. To our knowledge, there are no long-term     studies with DM to prove the benefits of resistant starch use. The objective of this study is     to assess the benefits of green banana biomass consumption by patients with Pre DM and DM.     Considering the possibility of improving glucose, lipid profile, increasing the secretion of     glucagon-like peptide-1 (GLP-1), insulin, adiponectin, and reduction in inflammatory markers     IL-6, PCR.   "
4257|NCT03230110|"     The purpose of this study is to identify whether pregnant women with chronic hypertension are     at significantly higher risk of having undiagnosed OSA and should be routinely screened with     home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks     gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be     enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood     pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment     for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the     chronic HTN group. The two groups will be matched for BMI to control for the effect of     obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs     between patients with chronic HTN and normotensive controls, will be assessed with a     two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided     significance level will have 92% power to detect the difference between a normotensive OSA     rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group     is 50. There are no risks associated with the use of the home sleep test device, but subjects     that have a severe latex allergy should not participate, as the device   "
4258|NCT03230097|"     To investigate the efficacy, safety and tolerability of BI 409306 once daily compared to     placebo given for 52 weeks to subjects with attenuated psychosis syndrome.   "
4259|NCT03230084|"     Infertility affects many people in Ontario and carries a significant amount of emotional,     physical and financial burden to those who experience it. Knowing when a woman ovulates is     important for improving a couple's chance to become pregnant naturally and for learning about     fertility problems, such as infertility, irregular menses, and hormonal disorders.      Currently, there are two reliable methods to confirm ovulation: a trans-vaginal ultrasound or     a blood test for progesterone, which is a hormone that only rises sharply after ovulation.     However, both are time consuming and expensive. Recently, an inexpensive, home-based urine     test strip has been developed to confirm ovulation. The test strip works by measuring urine     for a marker of Progesterone, called pregnanediol-3a-glucuronide (PDG).      The purpose of this feasibility study is to follow the use of this home-based PDG urinary     test strip over the course of one menstrual cycle in 25 female participants. The results of     the urine test strip will then be compared to a Progesterone blood test. Participants will be     recruited from the general Ottawa, Ontario area The ultimate aim of this study is to provide     information for the design of a larger study to determine the accuracy of the PDG urinary     test strip. If shown to be as effective in confirming ovulation, this test would provide     substantial cost saving to the Ontario health care system and a much more convenient way for     women and clinicians to confirm ovulation and determine if women are fertile.   "
4260|NCT03230071|"     The study will be a 24-week multicentre, double-blind, placebo-controlled phase Ⅱa trial with     4 treatment arms in China. Participants aged 55-80 years will be randomized to TMBCZG-high     dose(84mg per day), TMBCZG- medium dose(56mg per day), TMBCZG- low dose(28mg per day) or to     placebo. The primary endpoint will be VADAS-Cog and CDR-SB. Secondary outcomes included     changes in MMSE and ADL. Patients' safety will be assessed by recording of adverse events,     clinical examinations, electrocardiography and laboratory tests. The patients, caregivers,     and investigators will be blinded to the treatment allocations.   "
4261|NCT03230058|"     OBJECTIVE To evaluate the efficacy and safety of the concurrent treatment of 5% Natamycin and     1% Voriconazole in patients affected by fungal keratitis METHODS AND MATERIALS STUDY     POPULATION Patients with smear and or culture proven fungal keratitis presenting to our     Instituts, were eligible for enrollment.      STUDY DESIGN Prospective double masked randomized clinical trial.   "
4262|NCT03230045|"     Stimulation at acupoints could be of beneficial effects during the perioperative period. In     this study the investigators tend to verify the effect of dual acupoints stimulation on     pulmonary complications after abdominal surgery in aged patients.   "
4263|NCT03230032|"     The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a     pacifier-activated device (PAM) with mothers' voice to condition suck-strength and     rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for     CP.   "
4264|NCT03230019|"     This study evaluates the viability and safety of two-lumen catheterization versus chest tube     placement in patients with lung wedge resection. Half of participants will receive routine     chest tube placement, while the other half will receive a two-lumen central venous     catheterization along the midclavicular line, second intercostal space for remedial     gas-remove.   "
4286|NCT03229733|"     The aims of this study are to (i) develop exergames by using Kinect system for training UE     function in patient with stroke; and (ii) to test the game's feasibility and effects in a     group of patient with chronic stroke.   "
5959|NCT03207893|"     The purpose of this study is to determine if the use of continuous glucose monitoring with     the GEM lifestyle modification program (Glycemic load, Exercise and Monitoring glucose) will     result in better diabetes control than routine care.   "
4265|NCT03230006|"     Almost 18 million US adults have alcohol use disorders (AUD), with one third of these     individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD     imposes a high burden via healthcare costs and lost productivity. To date, existing treatment     approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is     a lack of adequate research to guide treatment decisions.      The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown     efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence     from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with     results from this study indicating a reduction from baseline in drinks consumed per day.     However, further evaluation of the UP for managing AUD/AXD is warranted.      In this clinical trial, the investigators will further assess the UP's effectiveness in     reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be     randomized to one of two conditions: 1) treatment with the UP or 2) treatment with     therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in     a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be     used to examine the effects of the UP on changes in brain activity in areas important to     regulation of emotional and reward processes implicated in excessive alcohol consumption.      The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1)     be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater     reductions in percent days heavy drinking, percent days of drinking per week, and alcohol     craving.   "
4266|NCT03229993|"     To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation     and treatment of angiographically borderline coronary artery lesions in a Chinese population,     and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the     participants included in the study will be those that are found to have borderline coronary     artery lesions on coronary angiography, in whom the investigators feel that OCT will be     useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or     whether optimal medical therapy is the most appropriate treatment modality. Those     participants who declined OCT will be offered SPECT as an alternative method to assess and     treat the borderline coronary artery stenosis.      It is estimated that OCT guided PCI or not has a non-inferiority to SPECT's in the     borderline coronary artery stenosis.   "
4267|NCT03229980|"     The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of     congenital heart disease encourage us to discuss problems that occur during this surgery     especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging     systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI)     as a result of cessation and re-initiation of coronary artery circulation   "
4268|NCT03229967|"     The purpose of this study is to advance our knowledge of the factors that contribute to the     development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants.     Specifically, the investigators will determine the complexity of the gut microbiota, the     genera of the bacteria that naturally live in the gut, and determine if the relative     diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the     investigators propose to characterize the microbiota of human premature newborns with BPD,     then validate this potential mechanism in mice. The investigators will enroll very low     birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le     Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A     cohort of well full term newborns may also be enrolled. Non-invasive stool samples will be     obtained weekly over the first month of life. Infants that eventually develop BPD will be     paired with infants that did not develop BPD. Stool samples from these infants will be sent     for analysis. The investigators expect that reduced complexity of the gut microbiome is     associated with BPD. The investigators will model the contribution of reduced microbiome     complexity to the risk to develop BPD or death, as well as the association with disease     severity. A companion study is also being conducted by the investigators exploring the     mechanism using mice. The project investigates important factors leading to the development     of BPD, and has the potential to directly translate to therapy for the most significant     pulmonary complication of prematurity.   "
4269|NCT03229954|"     Iron deficiency anemia is a common complication in patients who underwent gastrectomy and     leads to a deterioration in patient's quality of life. Therefore iron supplementation is one     of the important treatments in postgastrectomy patients.      Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients     has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron     supplementation has been emerged as another treatment option, but there are only a few     studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron     in patients underwent gastrectomy.      Therefore, this study aims to evaluate the iron supplementation method as intravenous     injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy     anemia.      Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and     hemoglobin level lower than 11 g/dL will be included in this trial. After the registration,     the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n =     179).      Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in     intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral     iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of     life score at baseline and weeks 12 period will be evaluated.   "
4270|NCT03229941|"     The goal of the proposed study is to determine whether a liberal transfusion strategy     (transfusion trigger at Hb < 10 gm/dl) in Veterans at high cardiac risk who undergo major     open vascular and general surgery operations is associated with decreased risk of adverse     postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at     Hb < 7 gm/dl).   "
4287|NCT03229720|"     Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market     technology for adults and children. Some practitioners started using this modality of     distraction in the dental practice to aid in psychological management of patients.      This study is designed to compare between conventional dental visits (No Distraction) and     dental visits aided with audio-visual distraction. Providing a safe, comfortable and     entertaining dental environment will give pediatric children a better perception regarding     the dental environment and motivate them for repetitive dental visits for better dental     health care.   "
4271|NCT03229928|"     The efficacy of clinical trials addressing behavioral issues in individuals with     intellectual/developmental disabilities (IDD) has traditionally been hampered by lack of     objective and sensitive measures. While there are many behavioral observation measures     available, most of them either rely on recall of the event or are designed for use by trained     professional observers, requiring a third party or extensive training for use. The Measuring     Outcomes for CHange (MOCHA) phone based application was developed to address the need for     feasible real-time tracking of behavior. For the current study, 2 parents of children with     IDD, 2 special education teachers, and 2 behavior health professionals will be recruited to     serve on a stakeholder advisory panel. These individuals will provide initial feedback on the     use of the application. Primary participants will be the parents and teachers of 10 children     or adolescents (age 5-17 years) who are seeking treatment and support for the child's     challenging behaviors (aggression, self-injurious behaviors, severe irritability) from     clinicians in the Behavior Medicine Clinic at the Carolina Institute for Developmental     Disabilities. Participants in the study will use MOCHA to record the child's behavior each     time it occurs over 6 weeks in order to test the feasibility of using MOCHA over time and in     response to treatment. The first 2 weeks of data collection will occur prior to the     participant's scheduled visit to the BMC. Following the clinic visit, where clinically     determined treatment suggestions will be provided, participants will continue to collect data     for 4 weeks to determine if long term data collection is feasible and if change can be     detected in response to the treatment through MOCHA (and compared to pen and paper     questionnaires). Two children will be chosen from this participant pool to wear a sensor     device to determine feasibility of syncing wearable sensors with the MOCHA app for use in     future research studies. Following the 6 weeks of MOCHA use, all participants will receive a     call or in person visit to conduct an exit interview about the participant's experiences     using MOCHA. The overall goal of this study is to determine the feasibility of the use of the     MOCHA application to track behaviors in populations of children with IDD. The MOCHA app does     not act as an intervention and is not modifying the environment of the participants, but will     be used as a tool by caregivers to track behaviors in real time.   "
4272|NCT03229915|"     Posttraumatic stress disorder (PTSD) is prevalent mental illness (~9% life-time) that results     from exposure to trauma. As it is associated with vastly heterogeneous origins, accurate     diagnosis and optimal treatment strategies are sometimes very difficult to achieve. No known     biomarker exists, which makes it difficult to assess treatment response and functional     outcomes. The recent brain imaging studies have suggested that PTSD patients show abnormal     brain connectivity measured by functional magnetic resonance imaging (fMRI). The     investigators propose that cognitive processing therapy may ameliorate this functional     connectivity abnormality which may be related with their symptomatic improvement.   "
4273|NCT03229902|"     There is an evidence gap on whether meditation may improve behaviorally measured attention     after stroke, but preliminary research is promising. This study is the first-ever     investigation of whether mantra meditation may improve chronic, severe impairment in     attention after stroke.   "
4274|NCT03229889|"     Extensive literature exists on the use of alpha-blocker medications for the removal of kidney     stones. Alpha blockers relax certain muscles and help small blood vessels remain open. They     work by keeping the hormone norepinephrine (noradrenaline) from tightening the muscles in the     walls of smaller arteries and veins, which causes the vessels to remain open and relaxed.     This improves blood flow and lowers blood pressure. There are studies that demonstrate     alpha-blockers decrease ureteral pressure and help the ureter relax.      Recent studies have shown that phosphodiesterase inhibitors may also help with ureteral stone     passing. A phosphodiesterase inhibitor is a drug that blocks an enzyme that inhibits     relaxation of smooth muscle. This means that it can help smooth muscle, such as the muscle     that lines the ureter, to relax. While ureteral relaxation is helpful in the passage of     ureteral stones, our study seeks to use this finding by pretreating participants with an     older generation alpha blocker or a phosphodiesterase inhibitor prior to passage of a     ureteral access sheath in cases in which ureteroscopy is being used to approach a ureteral or     renal stone.      By relaxing the ureter, it is possible that a larger access sheath can be safely placed. This     may allow for facilitating passage of the ureteroscope and extraction of stone fragments     while precluding the development of potentially damaging intrarenal pressure from the flow of     irrigant. The ureteral access sheath also protects the ureter from damage during the     procedure. Placement of the largest access sheath possible is helpful in that larger stone     fragments can be retrieved, the flow of irrigant is improved, and the surgical field is kept     clear of blood or debris. To date, nobody has studied whether use of an uro-selective alpha     blocker, alone, or in combination with a 5 phosphodiesterase inhibitor will result in passage     of larger access sheaths.      In this study participants will be randomized into 1 of 4 categories: Flomax (alpha-blocker),     Cialis (5-phosphodiesterase inhibitor), a combination of the 2, or a placebo arm. In this     study the placebo, or no active drug, is the current standard of care and will serve as a     control from the other 3 groups.   "
4275|NCT03229876|"     Universal CART(U-CART) has a great advantage for its allogeneic T cell resource. After gene     disruption of TCRα and HLA-1, U-CART will exempt from immunologic rejection by the receptor,     and won't initiate GVHD. Thus U-CART would act as a off-the-shelf product for the treatment     of tumor.   "
4276|NCT03229863|"     This study is examining the relationship between infant nutrition, gut health, and     development. The fecal microbiota changes and develops, in large part due to the food that     infants eat. These changes are important for many aspects of development. This study is     designed to examine how the fecal microbiota changes when exclusively breastfed infants are     first introduced to solid food, and how changes of the fecal microbiota are related to other     aspects of development.   "
4277|NCT03229850|"     This study will use the euglycemic clamp technique to evaluate insulin absorption when     insulin is administered subcutaneously in an area of subclinical lipohypertrophy vs an area     of normal tissue.   "
4278|NCT03229837|"     Survivors of childhood cancer often suffer treatment-related toxicities, including chronic     health conditions, high symptom burden and emotional distress, and decremented functional     status and quality of life. Although some patient-reported outcome (PRO) tools are available     for survivors of childhood cancer younger than 18 years old, very few studies have been     designed to evaluate longitudinal measurement properties of these PRO tools. In this study     the investigators propose to recruit participants from a cohort of diverse childhood cancer     survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve     assessment tools for PROs and health-related quality of life (HRQOL).      The purpose of this study is to measure the link between Patient Reported Outcome Measurement     Information System (PROMIS) and clinical assessments of childhood cancer survivors over time.     PROMIS is a questionnaire that measures patient-reported outcomes in adults and children.      The study plans to enroll 300 children. Surveys will be completed by the children and their     parents/legal guardians (a total of 600 surveys).      PRIMARY OBJECTIVES:        1. To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for          childhood cancer survivors by testing the association of change in PROMIS PRO scores and          the change in health status measured by objective clinical assessment. Age at baseline          and sex will be included in the analysis.        2. To establish clinically meaningful classifications of the PROMIS Pediatric measures for          childhood cancer survivors by referring PROMIS PRO scores to health status measured by          clinical assessment. Age at baseline and sex will be included in the analysis.        3. To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures          by referring to the change of health status evaluated by anchor-based anchors and          patient-based anchors for childhood cancer survivors. Age at baseline and sex will be          included in the analysis.   "
4279|NCT03229824|"     Surgical site infection (SSI) after breast and axillary surgery occurs more often than for     other clean surgical procedures. Infection in the setting of sick woman could delay the     adjuvant therapy and result increase morbidity and mortality. Also this increased costs     associated with health care.Surgical drains have been noted as a potential source for     surgical site infections. The primary aim of the study is to determine if chlorhexidine     occlusive dressings applied to the intervention drain sites effectively decreases rates of     bacterial colonization in drain fluid and drain tips compared to standard care.   "
4280|NCT03229811|"     The goals of this work will be to 1) develop an ACP educational intervention that will be     integrated into a standard pre-dialysis program and 2) evaluate its preliminary efficacy on     increased use of ACP among patients with advanced CKD and their families.   "
19816|NCT03026179|"     To determine if a brief primary care intervention can educate under-resourced and minority     parents about discipline in a way that is culturally sensitive.   "
4289|NCT03229694|"     Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may     cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension.     Thus, to effectively prevent the tourniquet related hemodynamic responses is important for     patients receiving limb surgery.      Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary     arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present     trial, the investigators are going to investigate the effect of Tracleer on     tourniquet-associated hypertension during total knee arthroplasty.   "
4290|NCT03229681|"     Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with     high mortality. After a long period of medical treatment or surgical treatment, patients     suffered great pain physically and mentally. How to improve the quality of life and prognosis     in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now.     Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous     stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for     CHF patients.      To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart     disease complicated with chronic heart failure (CHF). A randomized, controlled and     prospective clinical trial was designed.   "
4291|NCT03229668|"     The aim of this study is to assess the effect of pregabalin administration on     catheter-related bladder discomfort (CRBD). The study group includes patients that are about     to be subjected to urological operations because of the high incidence of CRBD observed in     this kind of surgical population.   "
4292|NCT03229655|"     Prospective, randomized comparison of the incremental dilation and stent exchange vs.     sequential stent addition approaches for management of anastomotic biliary strictures will     facilitate optimal management of patients who develop anastomotic biliary strictures after     liver transplantation.   "
4293|NCT03229642|"     Opioid use disorder (OUD) is prevalent and causes substantial health and social burdens.     Although evidence have showed the effectiveness of opioid agonist maintenance therapy in OUD,     high drop-out rate and the requirement of continuing use of opioid agonists are the major     problems. Therefore, to develop novel treatment for OUD is important.      Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method of brain     stimulation used to treat a variety of neuropsychiatric disorders. Recent studies showed that     there may be potential therapeutic effects in rTMS for addictive disorder, including reducing     craving and substance use severity. The underlying mechanisms of rTMS in treating addictions     may involve increased dopamine function in corticomesolimbic brain circuits and modulation of     neural activity in brain circuits that relevant to addiction. However, the treatment results     of rTMS in OUD were lacked, and the analysis in functional brain imaging study,     neuropsychological tests and other potential biomarkers under rTMS treatment were limited,     too.      Thus, the investigators will conduct the add-on double-blinded, sham-controlled study rTMS     treatment in 40-60 patients with OUD under methadone maintenance therapy. Patients will be     allocated to active and sham rTMS in a 1 : 1 ratio, and participants will receive rTMS on the     left dorsolateral prefrontal cortex (DLPFC) (15 Hz frequency, 4 seconds per train,     inter-train interval of 26 seconds, 40 trains per session, total 11 sessions in 4 weeks). The     treatment response, urine drug tests, craving scales and side effects to evaluate the     therapeutic effects of rTMS will be examined. Neuropsychological assessments, functional     magnetic resonance imaging (fMRI) and tests for potential biomarkers of immune parameters     will also be measured during 12-weeks follow up. The study results will provide the important     data in whether rTMS add-on methadone maintenance therapy is able to 1) reduce heroin use; 2)     reduce craving for heroin; 3) be an effective treatment for OUD, and 4) be associated with     improvement in fMRI, biological markers and psychological tests.   "
4294|NCT03229629|"     Pre-school undernutrition is a global problem with life long adverse consequences. One form     of undernutrition, chronic undernutrition or stunting, affects 171 million children under the     age of 5 worldwide. 35% of these children live in Africa. In Ethiopia, the focus of this     study, in 2014, 44.5% of children under 5 were stunted. Stunting is the consequence of     several factors including low birth weights, sub-optimal infant and complementary feeding     practices and repeated illness. In Ethiopia, complementary feeding is sub-optimal; only 4% of     children aged 6-24 months met the minimum dietary diversity recommended by WHO.      The investigators hypothesize four main reasons why many children and mothers in Ethiopia     fall short of best practice in terms of meeting nutritional needs and providing appropriate     childcare.      (i) Lack of information on healthy eating and appropriate child-feeding practices; (ii)     Limited affordability; (iii) Limited accessibility to markets and diverse food items; and     (iv) Limited peer effects in spreading information and adopting new practices.      This study will assess the efficacy of the interventions that address these four barriers to     optimal complementary feeding practices in Ethiopia. Using a cluster randomized control     design, mother-father-child pairs in two localities, Holeta and Ejere will be enrolled.     Treatment will be randomized at the garee (village) level. There will be five treatment arms     and a control group: T1, weekly maternal nutrition BCC sessions for four months; T2, weekly     maternal nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions     for three months; T3, receipt of a food voucher for six months; T4, weekly maternal nutrition     BCC sessions for four months and receipt of a food voucher for six months; T5 weekly maternal     nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions for three     months and receipt of a food voucher for six months; and C, a control group. Within     household, recipient of voucher (mother or father) will be randomly selected.   "
4295|NCT03229616|"     The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY     myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous     hematopoietic stem cell transplantation.   "
4296|NCT03229603|"     The Study goals are to test feasibility and acceptability of point of care HPV testing with     227 women already accessing an existing cancer screening program in Mumbai, India. Describe     HPV infection types in women screened. Compare if the quality of HPV clinician-collected and     self-collected samples are equally efficient to detect HPV and cervical cancer precursor     lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the     clinician-collected sample   "
4297|NCT03229590|"     Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children.     The primary source for the blood supply of the head of the femur is the deep branch of the     medial femoral circumflex artery. Loder described a classification for Slipped capital     femoral epiphysis based on ability of the child to walk or not(walking=stable,     non-walking=unstable).   "
4306|NCT03229473|"     People with chronic obstructive pulmonary disease (COPD) have balance problems and are at     risk of falling. New guidelines recommend balance assessment be included in pulmonary     rehabilitation (PR) however no specific tests are recommended. Our goal is to determine the     best balance test for identifying COPD patients who are at risk of falling. In this study,     COPD patients who report balance problems or falling in the last year will participate in a     testing session. Balance, balance confidence, lower body strength, exercise tolerance and     perceived physical limitations will be assessed. The number of falls over the following year     will be recorded using monthly calendars.   "
4307|NCT03229460|"     The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult     with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy     ang noninvasive ventilation.   "
4480|NCT03227198|"     This is a prospective, randomised double blind, controlled, parallel-group phase I and II     study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous     bone marrow derived mononuclear stem cells is safe and effective in hear failure patients     with reduced left ventricular ejection fraction(<=30%) when compared to a control group of     patients undergoing best medical care.   "
4298|NCT03229577|"     The Yale College Emotional Intelligence project aims to highlight the beneficial impact of     wellness programs for Yale students. The investigators will examine the benefits of 3     empirically-validated programs (Emotional Intelligence, KORU Mindfulness & YESplus Yoga     Breathing) for Yale students on measures of general well-being (e.g. perceived stress,     gratitude etc). The study will also include a no-treatment control group as a comparative     measure to the well-being programs. The goal of the study is to show how each program     benefits student well-being over time (immediately after the workshop and 1 month out from     the workshop). The hypothesis is that all 3 workshops will decrease stress and improve     well-being and that the manner in which each workshop will do so may be different (e.g. KORU     will benefit student well-being by increasing mindfulness and self-compassion whereas     Emotional Intelligence may benefit student well-being by improving cognitive emotion     regulation). In addition to the self-report measures, the study will measure physiological     outcomes of stress, heart rate variability, and sleep using a wearable device (Firstbeat).     Given the current state of mental health challenges and stress on college campuses, the goal     of this randomized-control trial is to strengthen the literature on wellness programs for     students and to show that student well-being can significantly increase through effective     interventions.   "
4299|NCT03229564|"     This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin)     in comparison to meshed STSG in children with partial deep dermal and full thickness burns.   "
4300|NCT03229551|"     The purpose of this investigation is to conduct a randomized controlled trial within a     subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol     treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt     biofilms and improve disease control. The effectiveness of topical surfactants is a research     gap in treating CRS but has promising correlates in other medical fields. Specifically, the     investigators will be studying the effect of topical xylitol therapy on biofilm production     with the use of PCR bacterial sequencing before and after medical intervention.   "
4301|NCT03229538|"     This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD),     safety and efficacy of methylprednisolone in neonates undergoing heart surgery with     cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled     safety and efficacy study. Blood samples will be collected from a subset of enrolled study     participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be     randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study     drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery     and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will     be followed for primary and secondary outcomes for the duration of their hospitalization.     Serious study drug-related adverse events will be collected for 7 days after the last dose of     study drug.   "
4302|NCT03229525|"     Post-traumatic Stress Disorder (PTSD) is a debilitating mental disorder that affects     approximately 7% of the general population. This project's aim is to develop a greater     understanding of the efficacy and underlying mechanisms of narrative exposure based     treatments for PTSD. Adult participants (N=162) who meet DSM-5 criteria for PTSD will be     enrolled in a 3-arm randomized clinical trial consisting of trauma-related expressive     writing, trauma-related expressive speaking, or a factual expressive writing control     condition. Treatments will be manualized and conducted entirely through the Qualtrics survey     platform. Treatment will consist of six sessions, three per week over two weeks, taking place     via the internet. Assessments will be conducted pre-treatment, post-treatment, and at 1-month     follow-up in the lab. Assessments will be comprised of symptom self-report measures as well     as two tasks completed in an eye tracker: a reading task to evaluate mechanisms underlying     trauma narrative processing and a sentence production task to evaluate attentional shifts     when producing verbal information      Specific Aims and Hypotheses:        1. Develop and test the relative efficacy of two cost-effective internet-based expressive          trauma therapies (written vs. spoken) relative to a non-trauma writing control for PTSD.          We hypothesize that both trauma-focused expressive therapies will achieve more favorable          outcomes at posttreatment and follow-up on measures of PTSD and depression symptoms,          posttraumatic growth, and quality of life compared to the writing control.        2. Conduct exploratory analyses testing baseline PTSD severity, depression severity, trauma          type, time since trauma, and emotional engagement in moderating the differential effects          of the selected expressive therapies.        3. Test the mediational effects of pre- to posttreatment changes in (1) active language          processing with eye tracking (i.e. how long certain words are fixated on). (2) selected          linguistic elements (i.e., frequency of emotional words, frequency of the pronoun I),          (3) perceived self-efficacy to cope with trauma memories; (4) perceived threat          appraisals associated with intrusive trauma memories on treatment outcome at follow-up.          We hypothesize that (1) fewer and shorter fixations on ideographic (i.e. personally          relevant) trauma words when reading the trauma narrative in the eye tracker will be          associated with reductions in PTSD symptoms at follow-up. (2) increased use of emotional          words over the course of writing sessions will be associated with reductions in PTSD and          depression symptoms at follow-up; (3) pre- to posttreatment increases in trauma memory          acceptance self-efficacy; and (4) pre- to posttreatment reductions in trauma memory          threat appraisals will be associated with greater symptom reduction at the follow-up          assessment.   "
4303|NCT03229512|"     Skin toxicities are a major complication to cancer therapies. They can be painful and limit     the amount of drug that can be received by cancer patients, preventing the patients from     receiving optimal doses of drug. One such cutaneous toxicity, hand-foot skin reaction (HFSR),     is caused by next generation targeted agents that are in routine use for the treatment of     kidney and liver cancer. HFSR is characterized by swelling, redness, and pain of the palms     and soles, in addition to the development of painful or thickened callus-like plaques with     fissures in areas of friction and pressure. We have identified a topical skin-directed     therapy, 1% topical sildenafil cream, that we believe will be useful in preventing and     ameliorating this painful, skin side effect associated with the targeted agents sorafenib and     sunitinib. This project proposal aims to conduct an open-label pilot study to assess whether     pre-medication with this cream can be an effective way of preventing or decreasing the     severity of hand-foot skin reaction, improving their quality of life on therapy and enabling     the patients to receive optimal amounts of their anti-cancer drug.   "
4304|NCT03229499|"     The primary objectives of this study are to determine whether the study drug, anastrozole may     improve six minute walk distance at six months compared to placebo and to assess safety and     side effects up to twelve months in pulmonary arterial hypertension (PAH).   "
4305|NCT03229486|"     The aim of this study is to investigate the effect of sugammadex vs. a conventional     acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during     sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features     of sugammadex compared to neostigmine will be examined by measuring the time from start of     administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and     0.9.      Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty     during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of     neuromuscular blockade with sugammadex in pediatric patients maintained with     sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular     blockade and decreased possibility of residual blockade.   "
4308|NCT03229447|"     This study compares two methodologies for improving access to medication assisted treatment     (MAT) in Ohio courts where MAT is currently restricted or prohibited. All participating     courts are asked to view two educational modules. Module 1 addresses the nature of opioid     addiction and treatment. Module 2 addresses concerns specific to criminal justice such as     misuse and diversion of medications. Courts selected for the experimental group also receive     a hands-on change team initiative in which specially trained professionals work with court     staff to provide education and instrumental assistance in order to improve access to MAT for     court supervisees who are opioid-dependent.   "
4309|NCT03229434|"     In a randomized crossover design, approximately 50 healthy participants will be randomly     exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an     anthropogenically influenced area and in a widely pristine area.   "
4310|NCT03229421|"     The purpose of this study is to determine whether any diagnostic patterns exist in the     symptom presentation of Zika Virus.   "
4311|NCT03229408|"     Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, ovulatory dysfunction     and polycystic ovaries. Insulin resistance (IR) is a common feature of PCOS, and the     resultant hyperinsulinemia is theorized to promote hyperandrogenism in the disorder. However,     30-50% of women with PCOS who are lean do not have insulin resistance. Women with PCOS also     exhibit chronic low-grade inflammation. In PCOS, glucose ingestion activates nuclear factor     ĸB (NFĸB), the cardinal signal of inflammation culminating in upregulation of the     inflammation pathway within mononuclear cells (MNC). This phenomenon is independent of excess     adiposity and is highly correlated with circulating androgens. In addition, in vitro exposure     to proinflammatory stimuli is capable of directly stimulating ovarian theca cell androgen     production. Nonacetylated salicylates suppress NFĸB activation and are well tolerated in     humans.      The proposed research is a randomized double-blind placebo-controlled study of 90 women with     PCOS. Forty-five subjects with PCOS (15 lean without IR), 15 lean with IR and 15 obese)     receiving salsalate, a nonacetylated salicylate, at an oral dose of 3-4 gm daily for 12 weeks     will be compared with 45 age- and body-composition-matched control women with PCOS receiving     placebo. The overarching hypothesis is that inflammation contributes to ovarian dysfunction,     independent of excess adiposity or IR.      The specific aims are, I: To examine the effect of salsalate administration on the ovarian     capacity to secrete androgen and on insulin sensitivity in PCOS. II: To examine the effect of     salsalate administration on the inflammatory response of mononuclear cells induced by lipid     ingestion and glucose infusion in PCOS. The approach involves evaluation of ovarian androgen     secretion in response to human chorionic gonadotropin (HCG) administration and insulin     sensitivity during the euglycemic phase of a two-step pancreatic clamp along with ovulation     monitoring before and after salsalate administration. The inflammatory response of MNC to     lipid ingestion and the hyperglycemic phase of the two-step clamp will also be evaluated     during treatment by measuring reactive oxygen species, the mRNA and protein content of     inflammation markers, NFĸB activation and cytokine release in culture.      The investigators expect that women with PCOS receiving salsalate will exhibit decreased     ovarian androgen secretion and reduced inflammation regardless of adiposity or IR status.     These results will be significant if they show a causal contribution of inflammation to     ovarian dysfunction in PCOS, thus improving our understanding of the pathogenesis of PCOS,     opening previously unexplored therapeutic avenues that are not necessarily dependent on     improving IR, and guiding the design of future studies aimed at determining what     interventions will optimally attenuate inflammation in PCOS to reduce medical disease and     enhance fertility.   "
4312|NCT03229395|"     Several studies have shown that lean mass, in particular muscle mass, is an excellent     predictive survival factor in many diseases. A better knowledge of the mechanisms responsible     for muscle atrophy and the identification of atrophic process markers are deeply needed for     the development of new anti-atrophic therapies. Either as drugs used to treat several medical     conditions or as endocrine hormones released in response to many stress situations (e.g.,     sepsis, cancer, insulinopenia…), glucocorticoids (GC) are recognized to play a major role in     skeletal muscle atrophy. Indeed, the inhibition of GC action by a receptor antagonist (RU486)     or by muscle-specific invalidation of the GC receptor inhibits the muscle atrophy in these     stress situations. Therefore, all these data clearly indicate that GC play a major role in     skeletal muscle atrophy observed in several conditions. Emerging evidence has revealed that     the skeletal muscle has a secretory function. Human skeletal muscle secretome was first     estimated at about 300 proteins by computational analysis and proteomic analysis have     recently confirmed these results. Some of these secreted proteins, conceptualized as     myokines, can act locally on muscle cells through autocrine/paracrine loops and on     surrounding tissues such as muscle blood vessels or can be released into the blood stream to     produce systemic effects. One prominent example is interleukin (IL)-6 which is released into     circulation by contracting skeletal muscle and can regulate metabolic and inflammatory     processes. As IL-6, several other potential myokines have been identified including IL-8,     IL-15, insulin-growth factor I (IGF-I), follistatin-like 1 (FSTL1) or fibroblast-growth     factor (FGF)-21. Moreover, secreted proteins may also reflected metabolic changes which take     place in muscle cells. Indeed, myoblast differentiation is accompanied by dramatic changes in     the secreted proteins profile as increased expression of Semaphorins, IGF-I, matrix     metalloproteinase (MMP)-2 or Collagens. Thereby, the investigators hypothesized that skeletal     muscle atrophy induced by GC is associated with specific alterations of the muscle secretome.     The aim of this project is to identify the GC-induced changes in the secretome of human     skeletal muscle cells in culture (in vitro approach) and to determine how these changes     translate into the circulation of subjects exposed to high concentrations of GC (Cushing's     syndrome) (in vivo approach). Characterization of these changes in human subjects should     allow to better understand the cellular mechanisms involved in muscle atrophy and might lead     to identify circulating biomarkers associated with skeletal muscle atrophy, as telopeptides     are for bone tissue.   "
4313|NCT03229382|"     The objective of the study is the evaluation of efficacy and safety of obinutuzumab     preemptive treatment at the time of the molecular relapse after first line immunochemotherapy     with autologous stem cell transplantation in mantle cell lymphoma patients.   "
4314|NCT03229369|"     Persistent rotational instability after standard ACL reconstruction have been extensively     described, and it has been shown to keep straight correlation with worse outcomes     post-operatively (Chouliaras 2007, Kocher 2004). Anterolateral ligament (ALL) injury have     been shown to play a relevant role in the genesis of rotational instability of the knee     (Claes 2013, Helito 2013). Many anatomical publications have defined the ALL as a distinct     ligament (Claes 2013). Meanwhile, some authors have proposed the association of ACL and ALL     reconstruction in selected ACL-deficient individuals to further enhance knee stability     postoperatively (Sonnery-Cottet 2015, Dodds 2014). Lack of consensus still predominates among     ACL experts regarding the reliability of the combined ACL and ALL considering the controversy     that involves both ALL anatomy and biomechanics (Guenther D 2016, Kittl C 2016). Clinical     trials with high level of evidence and long term follow-up may be useful in order to     determine the reliability of the combined procedure in the clinical setting.      So, the present study aims to compare the effectiveness of the combined ACL and ALL     reconstruction with isolated ACL reconstruction in individuals with high-risk of ACL     re-rupture, through a randomized controlled trial.   "
4376|NCT03228563|"     Probiotics could improve renal function parameters in uremic rats and significantly lower     levels of blood urea nitrogen in stage 3 and 4 chronic kidney disease patients. The aim of     the present study is to evaluate whether probiotics could retard the decline of renal     function in patients with chronic kidney disease?   "
4391|NCT03228368|"     This study is designed to evaluate the predicted potential of quantitative T cell repertoire     (TCR) of T cell receptor chains using next-generation sequencing (NGS) in the treatment of     the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab in participants with locally     advanced or metastatic NSCLC who have progressed during or following a platinum-containing     regimen. Treatment may continue until disease progression or unacceptable toxicity.   "
4392|NCT03228355|"     To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.   "
4315|NCT03229356|"     Smoking is the number one cause of preventable death in the United States. Given the     magnitude of the problem, interventions aimed at promoting smoking cessation have the     potential to make large changes in improving health outcomes. Resources to aid with smoking     cessation such as telephone-based counseling are generally underutilized. The electronic     medical record (EMR) in use at Johns Hopkins has limited decision support to promote referral     to the Maryland Quit Line, a free smoking cessation counseling resource. The investigators     propose a cluster randomized trial (Implementation-RCT hybrid design) with a waitlist control     at the 22 Johns Hopkins Community Physicians (JHCP) sites, which offer primary care. The     intervention will include a multi-modality intervention to promote provider use of smoking     cessation resources which include an Epic-based Best Practice Advisory (BPA) that allows     providers to electronically refer to the Maryland State Quit Line, educational materials, and     provider visits with Quit Line representatives to review use of smoking cessation practices.     Sites will be randomized to one of three arms with increasing support: 1) six-month waitlist     control; 2) BPA with optional educational modules; 3) BPA with online educational modules, a     quick-reference educational document, and additional visit with Quit Line representatives.     The investigators hypothesize that by implementing a new Epic BPA that allows providers to     easily refer to the Maryland Quit Line electronically, investigators will increase use of     this resource. The investigators also hypothesize that adding additional educational     materials and having Quit Line representatives perform educational outreach visits will     further increase use of the Quit Line and will increase prescription of medications to assist     with smoking cessation. Ultimately The investigators hope to improve patient care by     increasing providers' use the Maryland Quit Line and pharmacotherapy. The investigators hope     that the use of these resources will decrease smoking rates and thereby improve patient     health and outcomes while improving JHCP quality metrics.   "
4316|NCT03229343|"     Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median     between 2 and 4 years which leads to a profound alteration of the quality of life.      In thoracic oncology, the systematic and early intervention of a palliative care team result     in an improvement of quality of life for patients.      In the princeps study published in 2010, the early intervention of a dedicated palliative     care team was compared to standard care in a randomized trial of 150 patients and shows a     significant improvement : (i) of quality of life (main objective), (ii) of depression scores     and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of     understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted     hospitalization in end of life (in emergency or not).      Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory     symptom, psychological burden), it seemed reasonable to assume that the joint systematic     intervention of chest physician and palliative care team may provide a significant benefit in     terms of quality of life for patients with severe IPF.   "
4317|NCT03229330|"     This study compares the effect of adjuvant treatment of Low-level Light Therapy with     conventional treatment in the tissue repair of venous ulcers in patients undergoing     outpatient nursing consultation. For the evaluation of the cases clinical indicators of     Nursing Outcomes Classification have been used.   "
4318|NCT03229317|"     Early lung function deficits represent a significant risk factor for the evolution toward     chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke     exposure are already known to predispose children to develop a non-reversible obstructive     ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less     certain. In humans, low vitamin D concentrations during pregnancy are associated to an     increased risk of asthma in children. In murine models, low vitamin D concentrations during     pregnancy are associated to structural abnormalities of the airways in mouse pups.     Investigators hypothesized that vitamin D play a role in early airways development, from the     first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will     study the association of airway resistance in children aged 5 to 6 years old with the     concentration of vitamin D during the first trimester of pregnancy in their mothers.   "
4319|NCT03229304|"     The aim of the study is to evaluate the uterine artery doppler just before labour in term low     risk pregnancies. And to investigate with this measurement if investigators could foreseen     the amount of postpartum hemorrhage looking at decreased in the hematocrit values.   "
4320|NCT03229291|"     This study is a single-center, randomized, single-blind, placebo-controlled, multiple     ascending dose study of SM04755 solution applied topically once daily for 14 days to intact     skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of     80 cm^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1     (SM04755:placebo).   "
4321|NCT03229278|"     This phase I trial studies the best dose and side effects of trigriluzole in combination with     nivolumab and pembrolizumab in treating patients with solid malignancies or lymphoma that has     spread to other places in the body or cannot be removed by surgery. Trigriluzole may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as nivolumab and pembrolizumab, may interfere with the ability of tumor     cells to grow and spread. Giving trigriluzole in combination with nivolumab and pembrolizumab     may work better at treating patients with solid malignancies or lymphoma.   "
4322|NCT03229265|"     Hyperkalemia (high potassium in blood) is a common condition found in kidney transplant     patients. Risk factors include poor kidney function and exposure to various drugs. Regardless     of the causes, current treatment options are limited. Previously, the only available     potassium binder for lowering potassium in the blood is sodium polystyrene sulfonate, which     has unknown drug interaction profile with transplant medications. Patiromer is a newly     approved potassium binder indicated for the treatment of hyperkalemia. Kidney transplant     patients with hyperkalemia may benefit from patiromer. However, the interaction of patiromer     and transplant medications has not been studied. The goal of this study is to look into the     drug interactions between patiromer and transplant medications.   "
4324|NCT03229239|"     The purpose of this study is to determine whether corneal stroma implantation is effective in     the treatment of keratoconus.   "
4393|NCT03228342|"     Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients     classified in remission/low disease activity in terms of Patient Reported Outcomes.   "
4394|NCT03228329|"     aim of our study to validate electrical cardiometry readings against same readings by     transoesophageal echo. we will validate stroke volume (SV) readings stroke volume     variation(SVV), index of contractility.   "
4395|NCT03228316|"     Cancer-related pain represents a major challenge for both clinicians and patients. This pain     can be associated directly with the cancer or with certain treatments administered to the     patient. 52.1% of cancer patients suffer from pain and that 62.6% are not satisfied with the     current pain treatment. Pain prevalence is high in developing countries due to late diagnosis     and major impediments to opioid access   "
4396|NCT03228303|"     Nilotinib vs imatinib in patients with newly diagnosed CML-CP   "
5983|NCT03207581|"     The study will assess the effect of individualized professional coaching for mid-career     family medicine and general internal medicine physicians on burnout, job satisfaction, and     professional fulfillment.   "
4325|NCT03229226|"     Since 2007, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has     required evaluation of practicing attending physicians by management to ensure that     procedural skills and medical care are meeting the accepted standards of care as assessed by     each individual institution. This assessment is known as the ongoing professional practice     evaluation (OPPE). There are several methods by which this can be accomplished, including     through chart review of clinician practice and by verbally assessing knowledge of the steps     required to do a particular procedure. However, for infrequently performed or complicated     procedures, these methods may not allow objective evaluation on a regular basis. Simulation     using task trainers or manikin models offers an alternative method of objective evaluation in     a standardized setting.      The goal of this study is to develop two simulated scenarios to assess physician skill in     relatively uncommon procedures and compare the data obtained against the verbal assessment     and chart review model previously used at our institution. Two raters will assess each     practitioner's verbal and simulated procedures. They will also assess globally their     confidence that the physician is capable of performing the procedure safely and correctly     based on the verbal or simulated trial.      The investigators anticipate that using a simulated experience for assessment will increase     the ability of raters to assess proficiency for the purposes of an OPPE, specifically by     increasing the number of critical procedural components that can be objectively evaluated.     The investigators hypothesize that there will not be a strong relationship between the scores     obtained on the verbal assessment and the scores obtained on the task trainer assessment. The     investigators anticipate that there will be a portion of study participants that do not meet     a minimum passing standard and may require additional deliberate practice and further     testing.   "
4326|NCT03229213|"     Cystic fibrosis (CF) is a disease that affects multiple systems, however, the accumulation of     secretion in the airways contributes to the fact that pulmonary complications are the main     responsible for the high rates of morbidity and mortality. Physical exercise can be an     important component in the treatment of these patients, and modalities such as Nintendo Wii     and Xbox One stand out as feasible and innovative methods that can contribute to increase     adherence to rehabilitation. Thus, the objective of this study is to compare the     cardiorespiratory responses during a maximal exercise test with the use of Nintendo Wii and     Xbox One in patients with CF and healthy individuals. Patients with a clinical diagnosis of     CF, aged from 6 to 30 years old and in stable clinical conditions will be included. For     healthy individuals, those who are considered healthy from the application of a health     questionnaire and also aged from 6 to 30 years old will be included. Patients in both groups     with cardiopathies, musculoskeletal diseases, neurological diseases or signs of pulmonary     exacerbation will be excluded. Participants will complete a questionnaire to assess their     level of physical activity. Afterwards, cardiopulmonary exercise test (CPET) will be     performed (visit 1), followed by the use of video games (visit 2). The video game will be     practiced using a Nintendo Wii and a Xbox One (10 minutes each). A rest of 10 minutes will be     provided between the use of each video game. During the interactive games, patients will use     an accelerometer to assess the level of physical activity. In parallel to this, healthy     subjects will be invited to perform the same tests in two visits. To evaluate the perception     of fatigue, the OMNI scale will be used. In addition, individuals will be asked to evaluate     their level of satisfaction after each game.   "
4328|NCT03229187|"     Cervical cancer is one of the major health problems for chinese women. Besides surgery and     radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many     studies.      However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic     effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic     burden, but also more importantly save time to take more suitable treatments.      This study is undertaken to build specific molecular signatures to predict the effects of     neoadjuvant chemotherapy.   "
4329|NCT03229174|"     This is a double blind placebo controlled trial in Parkinson's disease (PD) patients with     neurogenic orthostatic hypotension (NOH). Investigators hypothesize that the study drug     (droxidopa) may improve cerebral perfusion more robustly than systemic BP, possibly by direct     action within the CNS vasculature. This study is designed to determine if droxidopa improves     cerebral perfusion measures in PD patients with NOH, in addition to peripheral BP measures     and subjective responses.   "
4330|NCT03229161|"     It is well-known that regular physical activity (PA) can improve glycemic control and     physical fitness in type 2 diabetes patients. However, studies examining the effects of PA in     patients with gestational diabetes mellitus (GDM) are limited. Interval walking training     (IWT) is a careful type of PA consisting of repeatedly cycles of 3 min. fast and slow     walking. The investigators aimed to examine, if IWT is feasible as PA intervention for GDM     patients, and to examine the effects of IWT on glycemic control, PA levels and physical     fitness.   "
4331|NCT03229148|"     Objective of the study: to assess whether pharmacological sedation or general anesthesia for     treatment of anterior circulation ischemic stroke with endovascular mechanical thrombectomy     is associated with difference in morbidity (neurological outcome and peri-procedural     complications).   "
4332|NCT03229135|"     This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive     infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from     February 2015 to August 2016.   "
4333|NCT03229122|"     The multi-centered, cross-sectional investigations shall be conducted in this study with the     objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with     epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.   "
4334|NCT03229109|"     Monitoring of a person's physical status is a key point for maintaining of healthy life.     Wearable devices provide a unique possibility for real-time monitoring. This study aims to     estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in     smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM     with the total weight lost during exertion.   "
4335|NCT03229096|"     Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer     PatientsWith lymph node metastasis   "
4336|NCT03229083|"     To determine if Carevive software, which monitors treatment-related toxicities and then     generates self-care management plans for these symptoms, will be feasible to implement among     patients with metastatic renal cell carcinoma (RCC). Additionally for collection of     preliminary data on treatment-related toxicities, quality of life, distress level, and drug     adherence.   "
5036|NCT03219957|"     This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics     (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In     addition, the study will assess the antiviral activity of AT-527 in subjects infected with     HCV.   "
4423|NCT03227939|"     This research is created for compare the difference of AHI variation between LSG and combined     surgery on obstructive sleep apnea in obese patients , evaluate the risk of combined surgery     and explore the correlative factor of the curative effect.   "
4337|NCT03229070|"     Post-lateral thoracotomies and assisted thoracic surgery (CTVA) are the main surgical     approaches for pulmonary resections. One of the counterpoints of these surgical approaches is     postoperative pain, which in addition to causing ventilatory changes and reduction of lung     capacities, contributes to bed rest and consequent decrease in patients' functionality. These     complications increase hospitalization time and hospital costs, being determinant factors for     perioperative morbidity and mortality. In order to prevent these outcomes of reduce the     functional capacity of patients, new physiotherapeutic approaches have been adopted, such as     the use of the cycloergometer. Recent studies show that the early use of this device brings     benefits such as: improved blood circulation and venous return, increased muscle strength,     improved functional capacity and reduced symptoms of dyspnea and fatigue. This study aims to     compare the effect of interval training with continuous cycle ergometer training on     performance in the six-minute walk test. Randomized and controlled clinical trial performed     with patients submitted to elective thoracic surgery, hospitalized at the intensive care unit     (ICU) and in the hospitalization unit of the Hospital Pavilhão Pereira Filho of the Santa     Casa de Misericórdia Brotherhood of Porto Alegre. Participants will be randomized into three     groups: control group (CG), interval exercise group (GHG) and continuous exercise group     (GEC). Functional capacity assessments will be performed through the six-minute walk test     (6MWT) and the chair sit and lift (TSL) test in 30 seconds, and evaluation of the clinical     state of fatigue through the revised Piper-Fatigue Scale. The evaluations will be performed     preoperatively and at hospital discharge.   "
4338|NCT03229057|"     To determine the effect of Oral Contraceptive Pills (OCP) verses Metformin verses OCP and     Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in     overweight/obese women with Polycystic Ovary Syndrome (PCOS).      The combination of OCP and metformin (OCP, through lowering androgens, and metformin, through     improvement in insulin sensitivity) will affect the prevalence of MetS, thereby altering the     risk profile for the development of diabetes and possible cardiovascular disease (CVD) in     young women with PCOS.   "
4339|NCT03229044|"     Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in     the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally     and systemically by secreting factors, called adipocytokines. Tetranectin (TN), a novel     adipocytokine, is secreted by adipose tissues. TN may regulate the glucose/energy homeostasis     to affect lipid accumulation.The role of TN in adipocytes with or without TN on regulation of     adipose tissue growth and lipid metabolism is valuable to be studied.      Materials and methods: Secreted proteins from human adipocyte culture medium were deciphered     using 2-D polyacrylamide gel electrophoresis and determined by LC/MS with MALDI-TOF analysis     of proteins. Adipose tissues were obtained from the breast of 15 women undergoing mastectomy.     Serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to     either a lean or obese group according to the body mass index. The TN protein concentration     was measured in the culture medium of stromal-vascular fraction (SVF)-derived adipocytes from     healthy humans, breast cancer patients, pigs and also from 3T3-L1 cells. Associations between     plasma TN and other biomarkers were assessed with Pearson's correlations and multivariable     linear regression.   "
4340|NCT03229031|"     To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery,     compared to a placebo control with spinal cord repairing surgery, on post-surgery motor     function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in     subjects   "
4341|NCT03229018|"     study target is assessment of the accuracy of linear measurement obtained from CBCT images on     3D volumetric rendering and multiplanar slices with different voxel sizes   "
4342|NCT03229005|"     The purpose of this clinical and radiographic study will be to determine what influence on     marginal bone loss has the thickness of soft tissues and the height of the prosthetic     abutment and eventually determine which of the two factors is the most important.This     research was designed as a multicentre cohort observational study. Eight clinical centers     will treat patients through the placement of a single dental implant. The implants will be     prosthetically loaded about 3 months after placement and periapical radiographs will be     acquired at each time-point.   "
4343|NCT03228992|"     The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing     the safety and efficacy of oral ibuprofen to placebo over 24 hours.   "
4344|NCT03228979|"     Recurrent stroke, cardiovascular morbidity and mortality are important causes of poor outcome     in patients with index stroke. According to INTERSTROKE study 80% of stroke are preventable     due to presence of modifiable risk factors. However lack of knowledge that stroke and     cardiovascular diseases are preventable is major hurdle to reduce the incidence of recurrent     stroke and cardiovascular morbidity. This is further compounded by the non-compliance to     medications, exercises smoking cessation and other lifestyle modifications.      Stroke awareness has proven to be useful in improving early arrival of stroke patients to     emergency thus increasing the thrombolysis rates. Early stroke prevention education using     print and audio-visual media may be useful. In addition the use of pervasive mobile phone     platform may help us reach patients during multiple intervals in a timely manner.      Study aims to use structured semi-interactive stroke prevention package to reduce the risk of     recurrent strokes, myocardial infarction and death in patients with sub-acute stroke after     one month.   "
4377|NCT03228550|"     The study will provide insight into how lifestyle-related interventions, specifically     nutrition and exercise can impact the health of older women. The study uses a unique     combination of interventions and encapsulates overall health outcomes by measuring both     mobility and cognitive function.      The study examines the effects of a combined omega-3 polyunsaturated fatty acid (PUFA) and     multi-nutrient supplement on measures of mobility and cognition in women aged 60 years and     above. Volunteers for the study will be randomly assigned to one of four groups which are as     follows:        -  Omega-3 PUFA multi-nutrient supplement and aerobic exercise        -  Omega-3 PUFA multi-nutrient supplement and no exercise        -  Placebo supplement and aerobic exercise        -  Placebo supplement and no exercise      Volunteers undertake the dietary supplementation for a period of 24 weeks. The active dietary     supplement contains a daily dosage of 1 g docosahexaenoic acid, 160 mg eicosapentaenoic acid,     240 mg Ginkgo biloba, 60 mg phosphatidylserine, 20 mg d-α tocopherol, 1 mg folic acid, and 20     µg vitamin B12. The placebo supplement contains an iso-calorific oil blend that is typical of     the current UK diet. The aerobic exercise consists of two classes per week the final 12 weeks     of the study on stationary spinning exercise bikes.      Volunteers attend testing at the beginning and after 24 weeks. Verbal memory, spatial working     memory, executive function and processing speed are assessed via a battery of cognitive     tests. Mobility testing comprises three walking tests, some under single and dual task     paradigms, as well as the five times sit to stand test, a measure of dynamic balance and     functional mobility. Volunteers also provide two blood samples, one for fatty acids analysis     and the other serum homocysteine levels. Participants also complete health-related quality of     life questionnaire, the short form 36 (SF36) questionnaire, food diary and food frequency     questionnaire.   "
4345|NCT03228966|"     Background: In children and adults living with HIV, cardiomyopathy is a major source of     comorbidity. Traditional echocardiographic measures are insensitive and consequently     cardiomyopathy often goes undiagnosed until late stages of disease. Myocardial deformation     imaging represents a promising means to identify early dysfunction, but to date there have     been no large studies using strain or strain rate to assess cardiac function in children with     HIV and to establish predictors of worse cardiac function such as viral burden and ART     regimen. These studies are critically important as earlier diagnosis and intervention     represent the best means to alter the course of HIV-associated cardiomyopathy.      Objectives: To determine the association of biomarker levels, myocardial deformation, and     viral load level history in HIV infected children attending Moi Teaching and Referral     Hospital (MTRH) clinic.      Design: A cross-sectional study on clients attending HIV clinic, MTRH. Setting: Module 4 HIV     clinic at MTRH in western Kenya, Africa. Population: HIV-infected children attending clinic     in 2017 - 2018 Main Measures: Echocardiographic function assessment, Age, Immune status,     other illnesses, ART status.      Conclusions: The study will explore the NIH/HIV High Priority Target area of HIV-associated     cardiac co-morbidities and will enhance understanding of the relationship between cardiac     function and viremia. The investigators expect to be able to reliably define a subset of     children with worse cardiac function by risk factors: specific ART regimens, less time     virally suppressed, and increased BNP biomarker.   "
4346|NCT03228953|"     This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate     clinical impact of pharmacogenomic testing on the treatment of major depressive disorder.     Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group     (guided group) and treatment as usual group (TAU group). The primary hypothesis is the     pharmacogenomic-guided treatment group will demonstrate significantly higher percent     improvement in depression score compared to treatment-as-usual group.   "
4347|NCT03228940|"     Fabry Disease (FD) is a rare X-linked lysosomal storage disorder (LSD) caused by mutations in     the GLA gene which translates into decreased activity or lack of function of the enzyme     alpha-galactosidase A (α-GAL A) and accumulation of the enzymes substrate, i.e., Gb3,     throughout the body. Cardiovascular and renal complications are among the leading causes of     death in FD patients. RVX000222 is a BET inhibitor which modulates the expression of a     variety of genes and, due to its effects on pathways downstream of substrate accumulation and     reduction of major cardiac events, holds promise as a potential add-on therapy to accompany     enzyme replacement therapy (ERT) in FD patients.   "
4348|NCT03228927|"     Questionnaires will be completed by each member of the twin set. A board-certified     dermatologist will examine each member to categorize the type and severity of their rosacea.     The facial and gut microbiome will be sampled and sent for microbial analysis.   "
4349|NCT03228914|"     The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which     are 2 different nasal decongestants both of which are routinely used before sinus surgery) on     blood loss and the surgeon's view of the surgical field during sinus surgery.   "
4350|NCT03228901|"     In this protocol registration, the investigators plan a secondary data analysis of a dataset     to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.   "
4351|NCT03228888|"     The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of     gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide     RAS consist of metronome or music-based sounds, which are not related with the auditory     experience of walking. Based on previous laboratory research, it is hypothesized that the use     of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a     greater impact compared to artificial sounds (i.e., metronome sounds), within a     rehabilitation program. In a double-blind experiment, it was investigated the effects of 5     weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD     (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions     (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables     were assessed before the rehabilitation period, at its end, and after a 3-month follow-up.     The results revealed that the rehabilitation program integrated with RAS had positive effects     on the majority of objective and subjective measures, independently of the type of sound.     However, when the two groups were examined separately, the patients assigned to the     ecological RAS condition were the only who improved both in terms of cadence and gait speed.     Overall, the hypothesized greater effect of the ecological sounds compared to artificial     sounds was only partially supported by data.   "
4352|NCT03228875|"     Early life exposures may lead to adverse effects on health in later life. The Boston birth     Cohort study is designed to study a broad array of early life factors and their effects on     pregnancy, infancy, and child health outcomes.   "
4353|NCT03228862|"     To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for     the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of     and risk factors for hypovitaminosis D among Thai adults.   "
4354|NCT03228849|"     This study aims to compare conservative treatment versus a new suture anchor technique for     bony mallet finger in 29 patients.   "
4355|NCT03228836|"     This is phase II study. Efficacy and safety evaluation of IBI308 in patients with     relapsed/refractory extranodal NK/T cell lymphoma, nasal type: a multicenter, single arm.   "
4378|NCT03228537|"     This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and     surgery with or without radiation therapy in treating patients with stage I-III pleural     malignant mesothelioma. Monoclonal antibodies, such as atezolizumab, may interfere with the     ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after     surgery may kill any remaining tumor cells.   "
5304|NCT03216447|"     A study of patient adherence and convenience to immunosuppressive agents in newly liver     transplant recipients - a prospective, multi-center, open-labeled, randomized clinical trial     for comparison between once-daily early conversion and twice-daily tacrolimus formulation.   "
4356|NCT03228823|"     Premature ventricular contractions (PVCs) coexist in patients with heart failure (HF) and LV     dysfunction. Frequent PVCs have shown to induce a reversible cardiomyopathy (PVC-CM).      This clinical pilot study will enroll 36 patients with frequent PVCs (burden >10%) and CM     (LVEF <45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, patients     will undergo a baseline cardiac MR if clinically indicated followed by 3-month observation     period (optimal HF medical therapy). Changes in LV function/scar, PVC burden/arrhythmias and     clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events     will be assessed throughout the observation period and compare with PVC suppression     strategies (RFA or AAD). Similar comparison will be made between RFA and AAD treatment groups     during a 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE)     study design. The treatment regimens will be compared in an intention-to-treat analysis. In     addition, a total of 20,000 consecutive ambulatory ECG Holter monitors from all participating     centers will be screened to identify all patients with probable diagnosis of PVC-CM.      This pilot study is intended to estimate the prevalence of this clinical entity and pave the     way for a large full scale randomized trial to identify best treatment strategy for patients     with PVC-CM. Treating and reversing this underestimated PVC-CM may improve patient's health     and subsequently decrease HF healthcare spending.   "
4357|NCT03228810|"     Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients     with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from     metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be     collected before treatment. If patients receive androgen deprivation, then blood will be     collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or     surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment,     after which no further patient contact will occur.   "
4358|NCT03228797|"     aim of this study is to compare the postoperative analgesia provided bya continuous     preperitoneal infusion versus ultrasound guided rectus sheath block for midline emergency     laparotomy.      anticoagulated patients   "
4359|NCT03228784|"     The study tried to find the relation between ablation depth and degree of dryness after LASIK     treatment of myopic patients   "
4360|NCT03228771|"     Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors)     and Statins separately , there has been a lack of clinical investigation into the     simultaneous use of these agents in socket augmentation. Therefore the main objective of this     study is to evaluate socket bone dimensions and quality following the use of PRGF derived     fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and     histomorphometrically.   "
4361|NCT03228758|"     The purpose of this study is to compare the safety and efficacy of the anterior versus     posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of     Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of     narcotics. The secondary outcomes focus on safety which includes technical procedure duration     time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and     non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal     reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure     pain scores, administrations of analgesia until discharge.      The final analysis will focus on determining whether there is a statistically significant     difference in the amount and severity of pain in the Anterior versus Posterior myotomy     subject populations. Additional analysis will be the collection of analgesic type (narcotic     versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure     in the endoscopy recovery suite until the subjects are discharged.   "
4362|NCT03228745|"     Despite surgical success of total knee arthroplasty (TKA), reports of dissatisfaction and     poor outcomes including increased pain, reduced function for daily activities, and     compromised psychological health are common. Interventions to improve TKA outcomes are     primarily education-focused, however there is little support for efficacy. Evidence suggests     that mindfulness based stress reduction (MBSR) is effective for improving both physical and     mental health, which are factors implicated in negative post-operative TKA outcomes. The     efficacy of this empirically supported intervention on TKA outcomes has not been assessed.     The proposed pilot study will conduct a randomized controlled trial to evaluate the     feasibility and efficacy of pre-surgical MBSR on post-surgical outcomes. Post-operative pain     (severity and catastrophizing), functioning (interference and illness impact), quality of     life, emotional distress (anxiety and depression) and sleep will be assessed in pre-surgical     MBSR and compared to treatment as usual. This pilot will provide an opportunity for TKA     patients to receive an intervention that may improve outcomes. Further, it will provide     insight into the relationship between pre-surgical MBSR and post-operative TKA outcomes,     which will assist in the development of MBSR adaptations to less time intensive, and     potentially more accessible, future offerings.   "
4363|NCT03228732|"     (1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac),     an antidepressant often used to treat depression, stimulates the participant's body's ability     to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone,     dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself     from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body.     However, it can be manufactured and is sold as an over-the-counter dietary supplement. The     dose the investigators are giving in this study is higher than the usual recommended dosage     taken as a supplement for certain medical conditions. (3) To study combined effects of     fluoxetine and DHEA during low blood glucose. In the present study, the investigators will     measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or     fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64     individuals with type 1 diabetes will take part in this study.   "
4397|NCT03228290|"     This will be a prospective cohort study of patients with cirrhosis who are listed for liver     transplantation. Subjects will undergo geriatric assessments of frailty, functional status,     and disability using functional status measures at baseline and at every clinic visit in the     pre-transplant setting. Subjects will again undergo functional assessments at every clinic     visit through 12 months after transplant.   "
5984|NCT03207568|"     The objective of the study is to evaluate the safety and performance of Relay Pro and Relay     NBS Pro devices in humans having thoracic aortic pathologies.      Clinical results will be used to apply for the CE certification.   "
4364|NCT03228719|"     Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR),     which results in clinically meaningful improvements in pain and physical function. However,     evidence suggests that physical activity remains unchanged after TKR. This randomized     clinical trial is investigating the preliminary efficacy, fidelity, and safety of a physical     therapist administered physical activity intervention for people after TKR.      Methods/Design: One hundred and twenty-five individuals, over the age of 45, who seek     outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control     and intervention group. The intervention group will receive a weekly physical activity     intervention during PT, which includes a FitbitTM monitor, individualized step goals, and     face-to-face feedback provided by physical therapist. Preliminary efficacy of the     intervention will be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity     (MPVA) using an Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months     from discharge from PT. The association of self-efficacy for exercise and kinesiophobia with     physical activity will also be measured at the same time points. Fidelity and safety of the     intervention will be assessed during outpatient PT.      Discussion: The overall objective of this study is to fill a critical clinical need to     increase physical activity after TKR. This protocol for a randomized clinical trial will     investigate the preliminary efficacy, fidelity and safety of a physical therapist     administered physical activity intervention for people after TKR. The findings will be used     to support a large multi-site clinical trial to test the effectiveness, implementation and     cost of this intervention.   "
4365|NCT03228706|"     Poor medication adherence (MA) among Type 2 Diabetes Mellitus (T2DM) patients had found to be     gnarly and devastating (Krass et al 2015; Sharma et al 2014). It was estimated that more than     half of the patients failed to achieve recommended glycaemic goals due to nonadherence     (García-Pérez 2013; World Health Organization 2003). Furthermore, greater adherence rate was     significantly associated with better glycemic control, fewer hospital visits and admissions,     and lower medical costs. On the other hand, lower adherence rate was significantly associated     with poor medication tolerance, the frequency of medication intake (> 2 times a day), having     concomitant depression and negative belief about the medications. Consequently, patients who     poorly adhere to medications would take more medications due to the poor glycemic control and     development of micro- and macrovascular complications (American Diabetes Association 2013).     Such condition would further worsen their adherence due to more complex medications and a     greater chance of experiencing drug-related side effects (García-Pérez 2013). This inevitably     increases the economic burden and wastage to the healthcare system (Meng et al 2017). Hence     breaking the vicious cycle is an urgent call to all stakeholders.      Notably, Ministry of Health Malaysia (MOH) had initiated several interventions in curbing the     MA problems at national level. One of those which has been perpetuated and led by pharmacists     is Know Your Medicine (KYM) Campaign since 2007. The national KYM campaign aims to promote     the quality use of medicines through mass communication and group-based approach. The     messages conveyed include information on their medication management such as why, how and     when to take medicines, reporting adverse drug events, awareness on the rational use of     medicines and medications that need special precautions. In specific, assuring and improving     medication adherence among patients is one of the important components of the campaign (PSD     2008).      In term of improving medication adherence among Malay T2DM patients, a structured group-based     intervention (SGBI) called Know Your Medicine - Take It For Health with abbreviation     KYM-TIGF, was created by the researchers of this study who work at Sarawak Pharmaceutical     Services Division in 2016 under the KYM campaign. The KYM-TIGF is a theoretical based,     patient empowerment, culturally appropriate and a combination of psychosocial, educational     and behavioral intervention. It is a one-off SGBI that aims to improve the medication     adherence through the message specially designed with a cross-theoretical framework as     recommended by Slater (1999). The model to measure the effectiveness of the SGBI is an     integrated model with Theory of Planned Behaviour (Ajzen 1991) as main theory and     Information-Motivation-Behavioural Skills Model (Fisher et al. 2006) as supporting theory.     The primary outcome of this study is the medication adherence level using a locally validated     scale MALMAS (Chung et al. 2015). The secondary outcomes of this study are the psychosocial     variables of the integrated model which include attitude to medication adhere, the subjective     norm to medication adherence, perceived behavioral control towards medication adherence,     adherence information, adherence skill and intention to adhere.   "
4366|NCT03228693|"     This study aims to examine both the genetic profile and the biomarkers implicated in keloid     scar formation.      Hypothesis:        1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given          population's propensity to develop keloids        2. Differences in biomolecules expressed in subjects with and without keloids can help          predict keloid occurrence and severity        3. Biomarker analysis will provide useful insights for future targeted therapies for keloid          scars   "
4367|NCT03228680|"     To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of     oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation   "
4368|NCT03228667|"     This is a Phase IIb, single-arm, open-label study of ALT-803 in combination with     pembrolizumab or nivolumab in patients with advanced or metastatic non-small cell lung cancer     who have progressed following an initial response to treatment with PD-1 checkpoint inhibitor     therapy. All patients will receive four cycles of treatment. Each cycle is six weeks in     duration. All patients will receive ALT-803. Patients will also receive either pembrolizumab     or nivolumab. Radiologic evaluation will occur at the end of each treatment cycle. Following     four cycles of combination treatment, patients will no longer receive ALT-803 but will be     eligible to continue their respective pembrolizumab or nivolumab therapy through 24 months,     at the discretion of the treating physician. Patients will be followed for disease     progression, post-therapies, and survival through 24 months.   "
4369|NCT03228654|"     Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof     the development of alternative treatments, the incidence of hysterectomy doesn't appear to be     declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined     approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients     with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy     for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be     performed in preference to abdominal hysterectomy.   "
4370|NCT03228641|"     A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology     for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe,     rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal     initiating a skin repair process through formation of new collagen and elastin fibers (skin     rejuvenation).   "
4371|NCT03228628|"     Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot     single-center study, it has been shown that nitrous oxide use during the procedure was able     to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this     multi-center trial is to confirm these results in a larger and more heterogeneous group of     patients having a LP.   "
4372|NCT03228615|"     The purpose of this clinical trial is to implement a multi-component shared decision making     intervention for families of children with IBD. The main objective of this research will be     to assess the acceptability, feasibility and clinical and decision outcomes of a     multi-component decision support intervention targeted at families of children with IBD who     are making decisions about treatment with TNFαi agents.   "
4373|NCT03228602|"     The aim of the study is to compare several parameters in three distinct groups of subjects:     persons with obesity, persons with obesity and diabetes and persons with neither obesity nor     diabetes:        -  the electrical activity in response to a sweet solution, measured before and after a          standard meal, using gustatory evoked potentials (recording explained below)        -  blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin:          measured in blood samples)        -  levels of activity and quantity of an enzyme present in the saliva, amylase, which is          able to break down ingested starch into several molecules of glucose.      All of these parameters will be correlated to determine whether the results are different in     the 3 groups of subjects in the study.   "
4374|NCT03228589|"     This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed,     parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of     daily intake of the probiotic strain Bif195 or placebo when co-administered to daily intake     of 300mg of Aspirin. The objective is to investigate the ability of Bif195 to attenuate     and/or reverse Aspirin-induced deterioration of the small intestine.   "
4375|NCT03228576|"     The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney     transplant. It combined immunosupressive properties of both products and reduce the     nephrotoxicity of tacrolimus by lowering the dosage.      The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack     of information justify a modality of use and tolerence evaluation of this new association,     commonly used.   "
4379|NCT03228524|"     An important mechanism responsible for clinical recovery after neurological damage of     different types is synaptic plasticity. Nervous tissue can enhance or de-energize     inter-neuronal transmission at synaptic level in a lasting way. By increasing the efficiency     of synaptic transmission, through long-term potentiation (LTP), it is possible to compensate     for the loss of synaptic pulses on survived neurons due to brain damage and to restore their     function.      At synaptic level, LTP is mainly regulated by NMDA receptors. In animal models induction of     plasticity in surviving neurons through the stimulation of NMDA receptors has been shown to     limit the clinical manifestations of neuronal damage. Endogenous NMDA is synthesized by     methylation of D-aspartate (Asp) by D-aspartatoartate methyltransferase . Moreover, Asp acts     as a neurotransmitter capable of activating the NMDA receptor, since its biosynthesis,     degradation, absorption and release occurs in the pre-synaptic neuron, and its release     determines a response in Post-synaptic neurons. The expression of Asp in the SNC is very     abundant during the embryonic period and in early years, whereas it is significantly reduced     in adulthood.      Consistent with Asp ability of activating the NMDA receptor, recent studies have shown that     oral administration of Asp increases LTP induction in mice. Preliminary studies by our group     also showed an increase in LTP amplitude in subjects suffering from progressive forms of     Multiple Sclerosis after 2 weeks of daily per os intake of 2660mg Asp.      It is also well known that the therapeutic exercise that characterizes a rehabilitative     treatment is able to induce various benefits to the physical-functional and the     cognitive-emotional spheres. In this regard, it has been extensively demonstrated how     repeatedly performing a motor task can increase cortical excitability through the induction     of LTP mechanisms.      Hypothesis Pharmacologically promoting the induction of cortical LTP by the intake of Asp in     subjects with various types of brain damage (eg Multiple Sclerosis, Parkinson's Disease,     Dementia) may favor the therapeutic effects of rehabilitative treatment.      Specific Objectives Evaluate the effects of Asp in improving the outcome of rehabilitative     treatment resulting from brain damage of different origin.   "
4380|NCT03228511|"     It is a Prospective descriptive hospital based clinical study to determine the value of     introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to     estimate the following :        1. Intraoperative judgement of lesions excision, residual parts, visualization and          operative corridor pre and after endoscope introduction.        2. Post-operative tumor control confirmed comparison between pre and postoperative MRI.        3. Postoperative complications, advantages and disadvantages compared with these when use          pure microscopic excision from the literature   "
4381|NCT03228498|"     The purpose of this study is to assess whether the combination of choline alphoscerate 1200mg     per day and nimodipine 90mg per day given orally is more effective than the combination     nimodipine placebo in reducing cognitive decline in patients with subcortical vascular     cognitive impairment   "
4382|NCT03228485|"     This study assesses the feasibility, and acceptability of a (mobile) application for men     presenting at the general practitioner with LUTS/BPH; starting with medical therapy and naïve     for treatment. Patients will be enrolled in the study by their general practitioner. The     patients will receive a daily medication reminder including frequent feedback on medication     adherence. Furthermore standard questionnaires will be filled out via the application. The     hypothesis of this pilot study is that application is feasible and accepted in this group of     patients.   "
4383|NCT03228472|"     Non-invasive cerebral stimulation techniques have shown potential in the treatment of     neurological disorders such as chronic pain, Parkinson's disease, neglect, aphasia, memory,     engine deficit and epilepsy In general, non-invasive cerebral stimulation techniques have     been shown to be able to induce changes in cortical plasticity that may last even beyond the     end of the stimulation period. Considering this potential, there is growing interest in the     application of these therapeutic techniques.      Hypotheses Based on these assumptions, the underlying hypothesis behind this project is that     the therapeutic use of cranial - electrical or magnetic stimulation - can aid the recovery of     various brain injury symptoms.      Specific objectives This study aims to provide preliminary data about the benefits of using     cortical stimulation to recover various brain injury symptoms. This will be made possible     thanks to the specific skills of a multidisciplinary team of neurologists and physiatrists,     healthcare professionals such as physiotherapists, occupational therapists, psychologists,     speech therapists and the support of a biomedical engineer. These professional figures are     already available at the UCK Neurosurgery of the IRCCS Neuromed directed by the proposer and     actively collaborate to optimize the therapeutic exercise of patients with neurological     damage.   "
4384|NCT03228459|"     Background and Objectives: Chronic kidney disease (CKD) and atherosclerosis are 2     interrelated diseases that increase the risk of cardiovascular morbidity and mortality. The     objectives of the ILERVAS project are: (1) to determine the prevalence of subclinical     arterial disease and hidden kidney disease; (2) to assess the impact of early diagnosis of     both diseases on cardiovascular morbidity and mortality and also on the progression of CKD;     (3) to have a platform with clinical data, vascular imaging and biological samples to define     a personalized cardiovascular risk profile.      Methods: Randomized intervention study. From 2015 to 2017, 14,600 people (7,300 in the     intervention group and 7,300 in the control group) aged between 45 and 70 years without a     previous history of cardiovascular disease and with at least one cardiovascular risk factor     will be randomly selected from the primary health care centers across the province of Lleida,     Spain. A team of experts will travel around in a mobile unit to carry out the following     baseline tests on the intervention group: artery ultrasound (carotid, femoral, transcranial     and abdominal aorta), ankle-brachial index, spirometry, determination of advanced glycation     end products, atrial fibrillation screening, dried blood spot and urine spot tests.     Additionally, blood and urine samples will be collected and stored in the biobank to identify     new biomarkers using omics studies. Participants will be followed up until 2027 to assess     whether the intervention group has any changes on medical treatments and lifestyle changes.     In addition, the incidence of cardiovascular events will be compared between the intervention     and control groups.   "
4385|NCT03228446|"     The investigators are interested in how attentional filter training/ distractor inhibition     training could influence cognitive functions like working memory, executive control, problem     solving, decision making and attentional control.   "
4386|NCT03228433|"     The purpose of this study is to evaluate the safety and tolerability of TAK-418 following     single oral doses in healthy participants.   "
4387|NCT03228420|"     This post-market study is being conducted to document comparative safety, clinical     effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with     CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic     neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective,     randomized comparison of the two treatments.   "
4388|NCT03228407|"     Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal     Reflux Disease (GERD)   "
4389|NCT03228394|"     This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of     Ganaxolone in Women with Postpartum Depression   "
4399|NCT03228264|"     The aim of this study is to investigate the effects of high-frequency short duration     tablet-based speech and language therapy (teleSLT) mixed with cognitive training (teleCT) in     chronic stroke patients. Recent studies suggest that chronic stroke patients benefit from SLT     with high frequency and that cognitive abilities can play a role in sentence comprehension     and production by individuals with aphasia. To investigate the effects of the distribution of     training time for teleSLT and teleCT the investigators use two combinations. In the     experimental group 80% of the training time will be devoted to teleSLT and 20% to teleCT     whereas in the control group 20% of the training time will be devoted to teleSLT and 80% to     teleCT. Both groups receive the same total amount and frequency of intervention but with     different distributions. At three time points (pre-, post-test and 8 week follow-up) the     patients' word finding ability is measured.   "
4400|NCT03228251|"     Acute stroke care is highly time critical for thrombolysis as well as thrombectomy. In both     scenarios, each minute lost reduces the therapeutic efficacy. Therefore, an optimal     implementation of these effective therapies into daily clinical practice is of utmost     importance for the translation of the evidence from clinical trials into good clinical     outcomes in routine care. In acute stroke therapy, the patient is cared for by an     interdisciplinary team and often has to undergo several handovers between different     caregivers with possible interface problems.      To facilitate a smooth workflow, the investigator developed an interdisciplinary stroke team     algorithm and implemented regular simulation-based team trainings at the investigators     institution. This multimodal intervention markedly improved the door-to-needle time for     thrombolysis (time from the patient's arrival in the emergency department to the start of the     tissue plasminogen activator (tPA) infusion) which is the most relevant benchmark parameter     for acute stroke care. The investigators monthly stroke team training had a positive effect     on the perceived degree of safety and staff satisfaction among the employees of the     investigators departments.      The investigator plans to investigate the benefits of the multimodal intervention of a stroke     team algorithm with regular stroke team simulation training in a controlled prospective     pretest-posttest trial design at seven leading stroke centers in Germany. The investigator     hypothesize that the implementation of a stroke team algorithm (defined team, defined tasks)     and regular stroke team training with a focus on efficient team work and communication will     improve process times, patient safety and staff satisfaction.      In the pretest period, the participating seven centers (tertiary care university hospitals     with thrombectomy capacity 24/7/365) record the data of all consecutive patients receiving     thrombolysis and/or thrombectomy during a three month period. Afterwards 3-4 leading     employees of different professional backgrounds (e.g. senior neurologist of the stroke unit,     neurointerventionalist, head nurse of emergency department) will be invited to a joint     train-the-trainer seminar at the sponsors institution where the participating centers     present their algorithm to the participants of all seven stroke centers for discussion to     invite suggestions for streamlining and improvement and a train-the-trainer course of stroke     simulation. After the seminar, the principal investigator and stroke team trainer will visit     all centers for one in situ stroke team simulation training and provide teaching materials.     Afterwards, each center will be invited to schedule two additional stroke team trainings a     with stroke team trainer that will be led by e.g. the senior neurologist from the respective     stroke unit with the aim of permanently starting up regular stroke team simulation. In the     posttest period, the participating seven centers again record the data of all consecutive     patients receiving thrombolysis and/or thrombectomy during a three month time period.   "
4401|NCT03228238|"     Purpose Objectives        1. To evaluate the anti-oxidant effect of long-term Vitamin C+E therapy on coronary          vasospasm improvement.        2. To evaluate the anti-oxidant effect of long-term statin therapy on coronary vasospasm          improvement.        3. To evaluate the effect of long-term Vitamin C+E and statin therapy on regression of          atheroma in target coronary vessels via intravascular ultrasound.        4. To find out the role of vascular endothelium in variant angina via evaluating long-term          Vitamin C+E and statin therapy on improvement in vascular endothelial function by          assessing brachial arterial expansion capability.        5. To find out the role of vascular endothelium in variant angina via evaluating long-term          Vitamin C+E and statin therapy on improvement in arterial stiffness by assessing pulse          wave velocity(PWV)   "
4402|NCT03228225|"     We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk     according to national guidelines. We plan to gradually reduce the number of institution based     CR and increase the tele monitored exercise sessions performed in the community. Stress test     will be preformed before the intervention and after completing 6 month.   "
4403|NCT03228199|"     This trial seeks to establish, using a randomized, controlled design, the impact of near     eyesight correction on the productivity of presbyopic agricultural workers in India, as     measured by weight of tea picked.   "
4404|NCT03228186|"     This study is a single institution Phase II single arm trial to assess the efficacy of the     combination of pevonedistat plus docetaxel in patients with previously treated advanced NSCLC     (non-small cell lung cancer).   "
4405|NCT03228173|"     This study aims to examine iron deficiency symptoms and biochemical iron status based on     hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females.   "
4406|NCT03228160|"     Background. Sympathetically maintained pain (SMP) can be effectively relieved by light     irradiation to the area near stellate ganglion (SGI), which is applied as an alternative to     sympathetic blockade. The clinical efficiency of SGI on heart rate variability (HRV) and its     association with pain outcome need to be further identified.      Objectives. This study is aimed to identify the effects of SGI on pain, HRV indices, quality     of life, and function outcomes.      Design. A prospective, double blind, randomized designed study Setting. An outpatient pain     medicine clinic Subjects and Methods. A total of 44 patients will be enrolled and randomized     to their allocations: the experimental group (EG, n=22) and control group (CG, n=22). All     patients in EG will receive 12 sessions (twice a week) of standard SGI, while those in CG go     through the same protocol except a shame irradiation is applied. Pain, HRV variables, quality     of life, and function outcoms are measured before and after SGI in each session. All measures     at the first-half and second-half courses are analyzed.   "
4407|NCT03228147|"     This pilot clinical trial studies sensory evaluation of oral nutrition supplements in     patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to     obtain input about new oral nutritional supplements that may increase nutrient intake and     maintain or improve nutritional status, functional capacity, and quality of life in cancer     patients.   "
4408|NCT03228134|"     We aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western     medicine in the treatment of asthma, and to further optimize the prescription of Chinese     medicine treatment.   "
4409|NCT03228121|"     The aim of this randomized, controlled crossover designed study is to compare the outcomes of     receiving autologous, adult stem cells versus placebo among participants with chronic     obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a     diagnosis of COPD. The study, along with others at the Lung Institute, have received full     review and approval of an Institutional Review Board.   "
4565|NCT03226093|"     Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient     in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The     SVF includes a variety of different cells and growth factors where the adipocyte (fat cell)     population has been removed. The use of SVF in the clinic for a variety of indications is     analyzed for incidences of safety and tolerability.   "
4410|NCT03228108|"     This study aims to assess the effectiveness and cost-effectiveness of rectal swab     culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal     prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral     ciprofloxacin (control group), while the other half will receive rectal culture-guided oral     antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal     swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis,     comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative     oral antibiotic based on the culture results will be prescribed     (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin).      The investigators hypothesise that the targeted prophylaxis group (intervention group) will     have a lower rate of post-biopsy infectious complications compared to the control group.   "
4411|NCT03228095|"     Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis     (skin, surgery material, other tissue) and exhaled breath is feasible using affordable     user-friendly novel nano-chemo sensors that can accurately be used for screening and     monitoring purpose   "
4412|NCT03228082|"     RATIONALE:      Women with a previous history of preeclampsia (PE)/HELLP have a twofold higher risk of     cardiovascular disease (CVD) and a fourfold increased risk to develop hypertension at a     relative young age. In the latest 2016 ESC guidelines 'CVD prevention', previous PE has been     acknowledged as a serious CVD risk factor in women. In clinical practice, however, these     women are still underappreciated for their CVD risk. It has not been established yet how     adequate lifelong prevention in these potentially high risk women can optimally be achieved     from their childbearing years onwards.      OBJECTIVE:      To evaluate feasibility, usability, acceptance and potential obstacles of blood pressure (BP)     home monitoring in high-risk women, aged 40-60 years, after a previous PE in pregnancy. In     addition to evaluate the effectiveness of BP home monitoring on the occurrence of     hypertension, the efficacy of BP treatment, quality of life (QOL), health-related symptoms,     work ability and life-style behaviour.      STUDY DESIGN:      Randomized, open label feasibility study to compare eHealth guided self management of BP     monitoring and lifestyle advice with 'usual care'.      STUDY POPULATION:      Approximately 300 women, aged ≥ 40 and ≤ 60 years, with a previous PE in pregnancy will be     invited to participate (both early and late PE). Patients will be recruited from the     departments of obstetrics/gynaecology in 6 centres in the Euregio Rhein-Waal and from the     department of cardiology Radboudumc.      INTERVENTION:      eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice     (intervention-group) will be compared with usual care.      PRIMARY OUTCOME:      Feasibility, usability, acceptance and potential obstacles of BP home monitoring in high-risk     women after a previous PE in pregnancy at 1 year of follow-up.   "
4413|NCT03228069|"     To study the humoral and cell-mediated immune responses in HIV-infected adults who had     previously received rabies booster vaccination more than a year before   "
4414|NCT03228056|"     This single-center, prospective, randomized controlled trial was designed to assess and     compare the postoperative pain after VATS lobectomy performed though one, two and three     incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary     outcome measure is cumulative morphine consumption up to 72 hours after surgery   "
4415|NCT03228043|"     Objective: To compare the outcome of patients with colorectal cancer who treated with     adjuvant therapy or Apatinib with adjuvant therapy postoperatively.      Language: English.   "
4416|NCT03228030|"     Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine     deficiency is common in HF patients. Previous small studies have shown that thiamine     supplementation can improve left ventricular systolic function in HF, but larger clinical     studies are lacking. Given the ease of supplementation and the potential benefits in HF, we     aim to conduct a pilot randomized controlled trial (RCT) using high dose thiamine     supplementation in HF patients. The main goal of this pilot study is to determine the     feasibility of recruitment for an RCT of thiamine supplementation.   "
4417|NCT03228017|"     This study will look at how chronic inflammation seen in psoriatic disease translates into     the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk.     The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic     disease and measures of vascular function. 2) Evaluate the association between moderate to     severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional     medications used in cardiovascular disease (CVD) prevention such as aspirin and statins     affect vascular function and thrombotic risk in those with moderate to severe psoriatic     disease.   "
4418|NCT03228004|"     The purpose of this pilot study is to determine if training and support, combined with     reminders to facilitate glucose data sharing with the diabetes care team in between clinic     visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have     HbA1c levels above target.   "
4419|NCT03227991|"     This study will determine the efficacy of Safety Planning Intervention (SPI) compared to     receiving risk factors and warning sign information (RWI) in recent suicide attempters during     the 6 months following an acute care visit on: (1) suicidal behaviors; (2) mental     health/substance use treatment engagement; (3) suicide-related coping strategies; (4)     suicidal ideation; and (5) use of means restriction.   "
4420|NCT03227978|"     Recent advances in thoracoscopic surgery have made it a commonly used technique for treating     spontaneous pneumothoraces and preventing recurrence. The goal of surgical treatment is to     find the offending bleb, remove it, and do some manipulation to encourage pleural symphysis.     Methods of thoracoscopic pleural symphysis have included mechanical abrasion and instillation     of chemical irritants. Each method reduces the rate of pneumothorax recurrence to a certain     degree, but the recurrence rates after thoracoscopic surgery are widely varied in the     literature. Although several articles show significantly lower rates, there are also articles     demonstrating that the recurrence rates of pneumothorax after thoracoscopic surgery ranged     between 5 and 12%, which are higher than the rates reported after open thoracotomy. It is     suggested that a less intense pleural inflammatory reaction is induced by thoracoscopic     procedure than by thoracotomy. Besides, post-pleurodesis severe pain and bleeding were     encountered frequently. A potential alternative to increase the intensity of pleural     inflammation and thereby prevent pneumothorax recurrence is film pleurodesis. Only few     studies have been reported where more than one film pleurodesis has been tried, and the     mechanism of film pleurodesis remains unclear.      Poly-ε-caprolactone (PCL) is a FDA-approved biomaterial with a slow degradation time of     approximately 24 months when degraded by hydrolysis only. Recently, some investigators     combined PCL with other biomaterials such as chitosan, polyethylene glycol, hyaluronic acid     to produce anti-adhesion barrier for clinical applications. However, only few studies report     PCL only could provide anti-adhesion effect. In contrast to common complications of     postoperative abdominal adhesions, adhesion (or pleurodesis) is an important therapeutic tool     to control the incidence of recurrent pneumothorax. We suppose that if a biomaterial induces     adhesion following abdominal surgery, perhaps it may be applied to pleurodesis tool for     preventing recurrence of spontaneous pneumothorax. We hypothesized that PCL membrane-induced     pleurodesis can be achieved intrapleurally.   "
4578|NCT03225924|"     The primary objective of the phase Ib of the study is to determine the recommended phase 2     dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP.      The primary objective of the phase II is to determine the complete metabolic response (CMR)     rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.   "
4425|NCT03227913|"     The aim of this study is to understand how dairy products enriched in minerals and proteins     are broken down in the mouth. More specifically, investigators wish to evaluate the link     between oral physiology (salivation and mastication) and formation of the food bolus during     the consumption of enriched cheese, that is to say the way in which the food is broken down     to be swallowed.      The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4     months. These two sessions will allow investigators to characterise the chewing behaviour of     the subjects and their salivation, and the structure of the food bolus formed when eating the     four products of the project.      For each of the four foods in each session:        -  Two samples of saliva will be taken        -  A video will be made of subjects eating one of the study products        -  Subjects will chew the study foods and spit them out.   "
4426|NCT03227900|"     World's population over 60 years old is increasing rapidly. It is expected that in 2050     elderly population will be 22% of the total population, representing around 2 billion people.     This situation means a rising in the incidence of elderly-related diseases, and thereby the     need for long-term care. Reduction in body fat and weight are a common problem among the     institutionalized elderly. Some factors that contribute to the anorexia of aging are     decreased perception of hunger and increased satiation. This represents an increased risk of     developing cachexia even during minor illnesses. The potentially severe consequences of     anorexia of aging a greater understanding of the underlying mechanism of these changes is     highly important. Intraesophageal and intragastric infusion of 20mg/kg lidocaine results in     an increase in food intake in Wistar rats. All infusions were done 30 minutes before the     start of the meal intake (meal consisted of mealworms). It may be possible to decrease     satiation, increase hunger, and hence food intake in elderly individuals through gastric     infusion of the anesthetics lidocaine or benzocaine. In the future this study could     potentially contribute to improve food intake in elderly vulnerable of losing body weight.     Therefore, the current study aims to investigate the effect of intragastric administration of     lidocaine on food intake, satiety/satiation and gastrointestinal complaints.   "
4427|NCT03227887|"     The aim of this study is to understand how foods such as Sponge cake or Brioche are broken     down in the mouth. More specifically, investigators wish to evaluate the link between oral     physiology (salivation and mastication) and (i) formation of the food bolus during the     consumption of Sponge cake or Brioche, that is to say the way in which the food is broken     down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning     the sensations that participant feel when they eat these products.      The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3     months. The first session will allow us to characterise the chewing behaviour of the subjects     and their salivation, and will enable us to train them in the instructions for the following     sessions. The 6 other sessions will allow us to study the structure of the food bolus while     being formed and the mouthfeel of the foods in the project.      In the first session:        -  Two samples of saliva will be taken        -  A video will be made of subjects eating Sponge cake or Brioche        -  Subjects will be trained in exercises for the following sessions - this will consist in          chewing the study foods and spitting them out on the experimenter's signal.      During the 6 other sessions, subjects will be asked to:        -  Chew one of the study foods and spit it out on the signal of the experimenter.        -  Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different          questions. This test will be done during 4 of the 6 sessions.   "
4428|NCT03227874|"     Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which     include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased     cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of     obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the     criteria. The number of people with diabetes is expected to increase dramatically over the     next decades, coinciding with rising obesity rates in many countries. Recent studies have     highlighted the beneficial effects of apple and apple products in reducing the risk of     chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The     primary objective of the proposed research is to determine the acute effect of consumption of     240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum     insulin, and fullness (satiety). The secondary objective of the proposed research is to     determine the acute effect of consumption of dried apple versus a low-fat muffin on various     cognitive domains. As with any organ, the brain requires nutrients to build and maintain its     structure and function, in order to perform in a harmonious manner and avoid damage from     aging. Epidemiological, clinical and basic research studies suggest protective effects of     several classes of nutrients against cognitive decline and risk of dementia. Twenty five male     and female participants between the ages of 20-45 years with a body mass index (BMI) between     18 and 25 will be recruited to participate in the study at San Diego State University. Each     participant will consume both test foods, the dried apple and muffin, on two separate visits     to the lab at least a week apart. The participants will come to each lab visit after a 10     hour overnight fast. After arriving at the laboratory, the participant's will complete a     cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive     tests on a computer. Next After arriving at the lab, blood samples will be collected from     warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain     an ample blood collection for analysis of baseline plasma concentrations of glucose and     insulin. The participants will then be given 5 minutes to consume the test food. Subsequent     finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The     participants will also rate their feelings of fullness on a visual scale prior to consumption     of the test food and every 15 minutes for two hours after consumption. After the completion     of the finger-prick blood samples and satiety questionnaires the participants will complete a     cognitive post-test which will be a different version of the cognitive pre-test battery.     Concentrations of glucose will be assessed by a handheld glucose monitor as well as an     enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all     dependent variables between the trials will be determined using a repeated measures ANOVA and     followed post-hoc when appropriate using paired T-tests to take advantage of the higher     statistical power provided by paired comparisons. Data will be reported as means +/- SD.     Significance will be selected at an alpha level of P < 0.05. These data may be useful as     finding a snack source that produces a lower glycemic response and a greater satiating effect     could be valuable in dietary counseling for blood glucose maintenance. For the cognitive     portion of this research, these data may be useful because there is considerable room for     improvement and for expanding evidence-based knowledge on the link between nutrition and     cognition.   "
4429|NCT03227861|"     The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/     Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of     care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive     participants as determined by the proportion of virologic responders defined as having     (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.   "
4430|NCT03227848|"     The differentiation between innocent and pathologic murmurs through traditional auscultation     can often be challenging, which in the end makes the diagnosis strongly dependent on the     clinitians experience and clinical expertise. With the development of technology it is now     possible to help diagnose heart murmurs using computer aided auscultation systems (CAA).     eMurmur is an investigational CAA system (not FDA approved) and the investigators hypothesize     that it can distinguish between AHA class I (pathologic murmurs) and AHA class III heart     sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity equal or     better compared to a similar FDA approved CAA system on market.   "
4466|NCT03227380|"     The objective of this study is to determine whether stapling adversely affects the pulmonary     parenchyma and the vascularisation of the adjacent segments. The aim of our work is to     explore by thoracic densitometry with contrast the spared segments after stapling of the     intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the     investigator will assess venous drainage and the arterial vascularisation of the remaining     segments, possible modifications of the adjacent parenchyma and whether there is a defect of     pleuro-pulmonary adhesion (residual pneumothorax).   "
4431|NCT03227835|"     After administration of intravascular iodinated contrast media Contrast-Induced Nephropathy     (CIN), also known as Contrast-Induced Acute Kidney Injury (CIAKI), may occur. CIN/CI-AKI is     associated with increased risk of dialysis and mortality. No treatment exists for CIN/CI-AKI,     therefore the focus lies on prevention. Clinical practice guidelines for the prevention of     CIN/CI-AKI exist and are implemented in most hospitals. Generally, intravascular volume     expansion with normal saline is recommended as prophylaxis.      Earlier this year the results of the AMACING study were published in The Lancet     (NL47173.068.14/METC 14-2-006; Clinical Trials.gov NCT02106234;     http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30057-0/fulltext). These     results show that for the greater part (>90%) of patients considered to be at risk of     CIN/CI-AKI by the guidelines, withholding prophylaxis is non-inferior to giving standard     intravenous prophylactic hydration in the prevention of CIN/CI-AKI. Furthermore, the standard     prophylactic hydration confers some risk (5.5% complications of intravenous hydration were     recorded in the AMACING study).      As a result the clinical protocol in the MUMC+ has been adapted, and patients with an eGFR     >29mL/min/1.73m2 no longer receive intravenous prophylactic hydration before or after     procedures with intravascular iodinated contrast material administration.      CINART aims to evaluate the consequences of this protocol change, especially renal function     and incidence of CIN/CI-AKI, in an observational study.   "
4432|NCT03227822|"     Since the length of lesion seems to be negatively associated with stent patency due to     restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1)     short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the     use of one long stent. This study proposes to evaluate the endovascular treatment for     patients with SFA lesions by comparing two strategies for patients with extensive occlusive     SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.   "
4433|NCT03227809|"     Alcohol abuse is the leading cause of death and serious injury among college students, and     students also experience significant harms from other types of substance misuse and risk     behaviors. The proposed project is a randomized controlled trials that will test the     protective effects of Letting Go and Staying Connected, a handbook for parents of students     who are transitioning for the first time from home to college, the time when students are at     greatest risk. The handbook encourages parent skill development and good management of their     student's new independence, providing a clear framework to guide them in parenting at this     stage. Targeted outcomes include reduction of substance use and risk behaviors. The primary     hypothesis is that students who are in one of the two handbook conditions with their parents     will report lower substance use and risk behaviors in the two years after college entry.   "
4434|NCT03227796|"     This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single     ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain     attributed to osteoarthritis of the knee)   "
4435|NCT03227783|"     Depression is common in Parkinson's disease (PD), but the effective treatment is not     established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The     tDCS on the depression in general population were already conducted, but not in PD. This     study is to know whether transcranial direct current stimulation (tDCS) is effective for the     treatment of depression in PD. Participant will be asked to visit three consecutive days for     the non-invasive stimulation.   "
4436|NCT03227770|"     This multi-center, open-label, randomized, parallel group study aims to investigate the     efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause     mortality and cardiovascular mortality in maintenance hemodialysis patients.   "
4437|NCT03227757|"     The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid     Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid     regurgitation (TR) in patients currently on medical management and who are deemed appropriate     for percutaneous transcatheter intervention.   "
4438|NCT03227744|"     This study is a clinical trial to determine whether a 12-week group therapy intervention for     patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related     anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal     of the study is to further our understanding of anxiety in men who have been diagnosed with     prostate cancer and are undergoing Active Surveillance. Men who have elected Active     Surveillance for their management of prostate cancer are eligible to participate in this     study. After signing informed consent, all participants will complete two brief     questionnaires (The Memorial Anxiety Scale for Prostate Cancer [MAX-PC] and the General     Anxiety and Depression Scale 7 [GAD-7] to measure their anxiety levels. If the participant     scores above a certain number, they will be asked to participate in the study. Patients will     be randomly assigned to either a control group, who will receive no treatment, but continue     to follow up with their urologist to manage their prostate cancer as usual, or the treatment     group. The treatment group will receive 12 one-hour group therapy sessions that will take     place once a week for 12 weeks with a licensed psychologist free of charge. They will be     instructed to follow up with their urologist as previously determined for their prostate     cancer management. Patients in both groups will be monitored for anxiety completing three     questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional     Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If     patients require further therapy beyond the group treatment sessions, the investigators may     refer them to a psychologist or psychiatrist for further treatment.   "
4455|NCT03227523|"     Introduction. Nonspecific low back pain (NSLBP) is a very prevalent medical condition,     especially in subjects with chronic obstructive pulmonary disease (COPD).      The diaphragm is a respiratory muscle, but it takes part in trunk stabilization on lumbar     spine. NSLBP is related to lack of spinal control. The COPD symptoms include lack of     efficiency in diaphragm, which could be connected to NSLBP.      Hypothesis and objectives. COPD can contribute to NSLBP. It is associated with diaphragm     weakness, severity of respiratory function, lower level of physical activity and quality of     life in COPD.      Methods. A descriptive observational cross-sectional study was conducted with two groups: the     first one with subjects with COPD and the second one with subjects without it. Data were     collected on: pulmonary function; respiratory muscles strength; trunk postural control;     quality of life with COPD; physical activity level; lumbar pain presence, intensity and     disability. Data were collected in a single session.   "
4439|NCT03227731|"     An Open Label randomized control study. To explore the safety of Truvada when used as PrEP     during pregnancy and lactation. Pregnant women considered at risk for HIV infection and     willing to participate in this randomized control study will be randomized to commencing PrEP     in pregnancy and continued use throughout breastfeeding or deferred PrEP until breastfeeding     cessation. All women will receive the standard of care for prevention of HIV and other     sexually transmitted infections.      Arm A: (Intervention): Standard HIV Prevention strategy PLUS a once daily dose of Truvada     (FTC 200mg/TDF 300mg tablet) initiated in pregnancy, continuing until cessation of     breastfeeding or 18 months postdelivery whichever is earliest and thereafter the option to     continue PrEP post breastfeeding cessation.      Arm B: (Control): Standard HIV Prevention strategy throughout pregnancy until cessation of     breastfeeding PLUS the offer to initiate PrEP post breastfeeding cessation.      Standard HIV prevention strategy includes risk reduction counselling, STI screening and     treatment, condom promotion and inviting the sexual partner to receive HCT and referral for     ART if he tests positive.      Main Outcome Measure: Renal function, pregnancy outcomes, bone health and infant growth.      Other Outcome Measure: Incident HIV infections, adherence to PrEP, drug resistance and     mother-to-child transmission of HIV.   "
5985|NCT03207555|"     The goal of this clinical research study is to learn if providing earlier treatment for CLL     or SLL with ibrutinib in patients who do not have symptoms will be more effective than     waiting until symptoms develop.   "
4440|NCT03227718|"     The researchers hypothesize that there is a correlation between Vestibulo-ocular reflex (VOR)     performance and innate athletic skill level. A similar study was conducted in female, young     adult gymnasts where a correlation was shown between VOR performance and gymnastic skill     level. However, the results from this study did not suggest that VOR differences develop as a     result of practice; rather that the differences in VOR may simply allow some individuals to     become better performers. In this study the researchers would like to extend the population     to adults both with and without a background in gymnastics to determine the natural     relationship between VOR and innate athletic potential.   "
4441|NCT03227705|"     Prematurity is the leading cause of neonatal morbidity causing more than 1 million deaths     worldwide per year. In 2012, a randomized controlled trial (RCT) testing pessary (silicone     ring placed around the cervix) versus no pessary in patients with a short cervix showed a     4-fold reduction in the rate of spontaneous prematurity <34 weeks of gestation and a     reduction in perinatal morbidity and mortality. This result was not found in a subsequent RCT     and another study on the subject had to be stopped in the face of slow recruitment.     Currently, the obstetric scientific community believes that other RCTs are needed before     using the pessary in the clinic as a therapeutic option to prevent prematurity in the     presence of a short cervix. However, before starting a large RCT, it is important to test the     feasibility of recruitment.   "
4442|NCT03227692|"     The purpose of this study is to compare the accuracy of knee component alignment between     patients operated with iASSIST Knee (Investigational group) versus patients operated without     iASSIST Knee (Control group) using the same implant system.   "
4443|NCT03227679|"     Nicotine mediates smoking's addictive effects in the brain. The ratio of 3-hydroxycotinine to     cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed     biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism. In light of     a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which     found that the NMR can be used to individualize treatment for smokers, our pilot study aims     to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical     populations of daily smokers.   "
4444|NCT03227666|"     Today most fracture prevention measures targets the bone and osteoporosis. However, only     about 20% of individuals with fractures have osteoporosis and at least 90% of all fractures     are caused by a fall. Therefore, the present project builds on previous findings from our     group identifying postural sway as an important risk factor for falls and aims to intervene     against this risk factor in a randomized controlled trial targeting subjects at the highest     risk for falls.   "
4445|NCT03227653|"     Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing     evidence shows that central nervous system side-effects in adults are more common than     previously thought. Due to lack of validated tools and small sample sizes, reliable data in     children are lacking. As HIV-infected children nowadays have a prospect of reaching     adulthood, there is an urgent need to identify potential long-term central nervous system     side-effects, interfering with neurodevelopment and psychosocial maturation.      In this cross-sectional observational study the investigators will examine neuropsychiatric     and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination     antiretroviral therapy (cART) with or without efavirenz.   "
4446|NCT03227640|"     This is a prospective, multicentric (two centers: 1:San Raffaele Scientific institute, Milan,     Italy; 2:Jagiellonian University, Collegium Medicum, Cracow, Poland), randomized (1:1)     clinical trial that includes patients undergoing surgery for primary unilateral or bilateral     symptomatic endometriomas.      The aim of the study is to determine whether and to what extent the two surgical procedures     for endometrioma, cystectomy and laser vaporization, affect ovarian reserve. Recently,     cystectomy has been questioned as an ideal surgical approach because it may involve excessive     removal of ovarian tissue and the loss of follicles; laser vaporization has been proposed as     a promising method to preserve ovarian function.   "
4447|NCT03227627|"     Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment     includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist     on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics.     There is no literature available for the efficacy of LNMES in the treatment of dysphagia on     patients with tracheostomy tubes. The purpose of this study to determine the outcomes on     dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the     investigators aim to determine the relationship between parental stress and a child's     modified diet.   "
4448|NCT03227614|"     This study aims to explore patient, support person, and health care providers' experience and     satisfaction with social support in the abortion procedure room. Although some providers do     allow a support person in the abortion procedure room, no study has formally examined the     effects of this practice.      If this study demonstrates higher patient satisfaction and lower perceptions of pain and     anxiety levels in patients who have social support in the in-clinic abortion procedure room,     this could change standard procedures in the in-clinic abortion procedure room, allowing for     more positive patient experiences.   "
4456|NCT03227510|"     Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third     leading cause of cancer that related death in the worldwide. Although, current most of     doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI,     CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein (AFP)     which characterized by very low of sensitivity in the detection of HCC. Last two decades,     scientists was focused researches of small molecules called MicroRNAs which are produced by     human cells and can be released in the blood.      MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging     non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and     to predict prognosis. A number of studies exposed an abnormal expression of human serum     MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently,     MicroRNAs have a role in the development of HCC, but still it is unknown if these small     molecules will be used as biomarker for diagnosis and survival of HCC.      The aim of this study is to establish MicroRNAs as biomarkers for diagnostic tool of HCC     patients and to compare to circulating levels of MicroRNAs in chronic liver diseases patients     and health volunteers and those HCC patients and To determine the clinical utility of     MicroRNAs as a diagnostic maker of hepatocellular carcinoma comparing with alpha fetoprotein     the current marker of (HCC).   "
4449|NCT03227601|"     Congenital Zika virus syndrome (SCZv) has been gaining attention in studies due to changes in     the central nervous system and in the motor development of children. These changes resulted     in an unexpected picture and without future predictability, with the appearance of several     functional impairments and also on orthostatic posture. In this context, the protocol of     orthostatism proposed here is a 10-week program of the use of a postural adjuster, the     standing frame, made of its own with alternative material to the commercial models     (cardboard). The use of low cost materials allows these devices to be made in the desired     size without cost high, individually adapted, easy to be transported as it is light and can     still be colored. It is an equipment that offers the opportunity to experience the     orthostatic posture and mainly benefits children with little economic resources that enable     the acquisition of traditional devices made of iron or wood and even imported equipment. The     postural adjuster allows physical and sensorial opportunity, being an auxiliary resource in     standing positioning, feasible for home use, besides being useful for performing functional     activities. Thus, the objective will be to analyze the repercussions of the use of the     standing frame on body alignment, muscle tone, gross motor function and gastrointestinal     functions of children with SCZv. An uncontrolled intervention study will be conducted with     children between 12 and 24 months of age, who will undergo an evaluation before use and after     the use of the adjunct along with the proposed orthostatism protocol. The postural alignment     will be evaluated through photogrammetry and the evaluation of muscle tone will be performed     through the modified Tardieu scale. The Gross Motor Function Measure (GMFM) scale will be     used to assess the gross motor function of the children involved in the study. Questionnaires     will be applied for the collection of maternal socio-demographic data, the child's data, the     type and time of therapy that the child already participates, and the gastrointestinal     functions. Evaluations will occur in four moments: initial / before use, on the first day of     placement in the adjuster, after the first month after use and after the second month of use.     For statistical analysis, the Shapiro Wilk Test will be applied to evaluate the normality of     the data, and the Friedman or ANOVA tests for repeated samples, to analyze intra-group time     factor for the dependent variables of each individual.   "
4450|NCT03227588|"     The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary     interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with     intermediate angiographic stenoses. It is a clinical tool used routinely in cardiac     catheterization laboratories throughout the world including the Little Rock VA Hospital. The     technique utilizes a pressure transducer constructed as part of an 0.014 guidewire. An FFR     of >0.80 has been linked with myocardial ischemia found with nuclear stress and dobutamine     echo stress testing. The FAME trial clearly demonstrated its value in improving long-term     outcomes as compared to use of angiography alone. As such, the use of FFR is incorporated     into both AHA ACC and European PCI guideline recommendations as part of routine care for     intermediate lesions. A work horse guide wire is so defined because it can be used in most     PCI cases. It combines a low tip load (to avoid intimal dissection, with excellent (ideally,     one to one) torque transmission and trackability through tortuous lesions. Recently the FDA     has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) which uses light     transmission to measure pressure rather than electrical transduction wires. The primary     purpose of the present study is to determine how effective this wire is as a work horse wire     in patients in whom FFR is required. The OptoWire may also have the advantage of less drift     occurring during the procedure. Drift refers to the change in pressure due to issues related     to the wire and measuring system, rather than a true change in pressure. All current FFR wire     systems demonstrate some degree of drift requiring measuring pressure of the wire in the     aorta after the procedure is completed to determine if, and to what extent, drift has     occurred. Thus, a secondary aim of this study will determine the degree of drift.   "
4451|NCT03227575|"     Physical activity is shown to positively reduce the risk of developing both cardiovascular     disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity     cardiorespiratory exercise five days per week. However, studies report that <40% of young     adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to     40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity     exercise have been shown to improve glycemic control in young and middle-aged sedentary     adults, however, long term implementation of such exercise regimens are difficult. Recent     evidence suggests that short bouts (15 minutes) of moderate intensity walking following a     meal, significantly improves glycemic control in older adults with impaired glucose control.     Due to the low burden of walking on participants, moderate intensity post-meal walking might     be a better alternative exercise intervention to improve overall health in a sedentary     population. Therefore, the purpose of this proposal is to determine if 15 minutes of     post-meal walking is an effective intervention to improve glycemic control in sedentary young     adults at risk for developing MetS.   "
4452|NCT03227562|"     Risperidone at low dosage is often used as treatment of acute anxiety symptom. However,     patients may be either responder or not. Here we hypothesized that the early response to a     low dose of risperidone is predictive to risperidone efficiency.      Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone     prescription would be proposed to be enrolled in the study. A check-up is made at D0, then     the subjects begin the treatment (0.5mg risperidone). The same check-up is carried out on the     following day (D1). The subjects fulfil a last check-up 12 week after the beginning of     treatment (W12). During the D1-W12, the psychiatrist may changes the treatment.   "
4453|NCT03227549|"     Hip replacement surgery is an effective option for treating pain and functional impairment in     chronic hip conditions. Various surgical approaches have been developed to expose the hip     joint for the procedure, each with advantages and disadvantages. The posterior approach (PA)     to total hip replacement is a commonly used exposure method. This approach involves a large     incision and requires multiple cuts through muscle and other soft tissues to expose the hip     joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation     compared to other exposures. The direct superior (DS) approach has been developed to improve     the PA by decreasing the amount of soft tissue injury at the time of surgery and improving     postoperative stability. The DS approach involves a much shorter incision and reduces the     need to damage as much soft tissues surrounding the hip joint during exposure. Specialized     equipment developed for this technique allows the surgeon to place the hip replacement     components. The proposed research study is designed to address a deficit in knowledge     regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This     study will provide much needed insight into the advantages and disadvantages of the DS     approach as compared to PA for total hip arthroplasty.   "
4454|NCT03227536|"     This is an historic cohort study based on the birth and delivery register of the HFME     maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all     gestational ages, identifying causes and describing neonatal outcomes since 2000, when a     second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas     cord blood were introduced in our maternity ward.      The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main     factors including second line strategy introduction, systematic umbilical cord acid-base     implementation and improvement in antenatal risk factor screening for asphyxia. The     investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was     improved with systematic early after birth EEG evaluation, allowing early treatment and     surveillance.   "
5986|NCT03207542|"     The goal of this clinical research study is to learn if daratumumab can help to control B- or     T-cell acute lymphoblastic leukemia (ALL). The safety of daratumumab will also be studied.   "
4457|NCT03227497|"     This cross-over study investigates health effects of dietary intake of whole walnuts towards     cardiovascular risk factors in adults under low cardiovascular risk.      Investigators hypothesize that daily intake of whole nuts as a replacement meal, would     improve cardiovascular risk factors, including traditional risk factors and molecular     biomarkers.      The participants are randomly assigned to receive either study treatment, or no treatment,     and are crossed after five weeks.      The study subjects are instructed to continue with their habitual diet and physical activity.   "
4458|NCT03227484|"     Recently, various sodium glucose cotransporter 2 (SGLT2) inhibitors have been approved for     the treatment of type 2 diabetes mellitus. Empagliflozin is a preparation of this class of     substances. SGLT2 inhibitors also lead to a reduction in body weight in addition to their     blood glucose lowering effect. The basis for this is probably the calorie loss by the     increased glucose excretion over the urine. However, this weight-reducing effect is lost     after a few weeks of treatment and the body weight subsequently stabilizes at a lower level     than before. However, patients continue to lose energy via the urine. Hence, the weight     stabilization could be due to an increased energy intake as a possible consequence of a     changed brain setpoint for the body weight. As the main weight loss is achieved during the     first 6-8 weeks of treatment, the investigators assume that the underlying central nervous     mechanisms will be present after this time.      Furthermore, clinical-experimental observations show that treatment with empagliflozin     promotes endogenous glucose production in the liver. This presumably compensatory mechanism     also occurs after only a few weeks of treatment. The common mechanism, which could be based     both on energy intake and on the endogenous glucose production effect, is still unclear. The     investigators suspect that regulatory circuits in the brain contribute to these observed     effects.      In fact, several studies in animals as well as initial clinical studies in humans show that     the brain is involved in eating behavior and peripheral metabolism. In particular, effects of     the hormone insulin modulate the dietary intake via the brain, thereby affecting human body     weight.      Many of the experiments on the insulin sensitivity of the human brain used a specific     approach to the selective delivery of insulin into the brain: the application of insulin as a     nasal spray. Although this application route has no therapeutic value, this technique allows     the administration of insulin to the central nervous system with little effect on the     circulating insulin levels. By combining nasal insulin administration with functional MRI,     regional insulin sensitivity of the brain can be quantified. The investigators recently found     that the insulin action of the brain (stimulated by nasal insulin) regulates both endogenous     glucose production and peripheral glucose uptake during hyperinsulinemic euglycemic glucose     clamps. The signals from the brain seem to reach the periphery via the autonomic nervous     system in order to modulate metabolic processes. A central brain area in this regard is the     hypothalamus. This brain region receives afferents over various systems such as the autonomic     nervous system and various endocrine systems (including insulin). The investigators recently     characterized the hypothalamus as an insulin-sensitive brain area in humans. The hypothalamus     is the key area for homeostatic control throughout the body.      Since the dietary intake and the endogenous glucose production are modulated by a     hypothalamic insulin effect in humans, we suspect that the observed effects of SGLT2     inhibitors on both processes could be due to altered insulin activity in the brain. Since the     SGLT2 inhibition by empagliflozin modulates the autonomic nervous system in the kidneys,     signals from the kidney may be transmitted to the brain via the autonomic nervous system,     thereby changing specific setpoints, including e.g. insulin sensitivity of the brain.      In order to test this hypothesis, a precise phenotyping of prediabetic volunteers with regard     to regional brain insulin sensitivity as well as the brain effect on metabolism before and     after 8 weeks of treatment with empagliflozin compared to placebo is planned.   "
4459|NCT03227471|"     This is a first-in-human and proof-of-concept study of VX-445. The study includes 5 parts.     Parts A, B, and C will be conducted in healthy subjects. Parts D and E will be conducted in     subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF     transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for     the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ,     IVA, or TEZ/IVA (F/MF genotypes).   "
4460|NCT03227458|"     To determine whether the musculoskeletal adaptations to bone-loading exercise can be     significantly augmented in older women (aged 60-85) with low bone mass (osteopenia; T-scores     <-1.0 and >-2.5) by restoring serum DHEAS to young adult levels by oral DHEA replacement.   "
4461|NCT03227445|"     This randomized, cross over study aims to find out the benefits of delivering triple therapy     using a single ELLIPTA® DPI (fixed-dose combination triple therapy) versus delivering triple     therapy using two different types of inhalers (open triple therapy) including DISKUS® with     HandiHaler® to subjects with COPD. Correct inhaler use, critical errors and performance     attributes will also be assessed. Approximately 240 subjects with COPD will be randomized in     the study. The study will be conducted in 3 visits and will be completed in approximately 56     days. At Visit 1 (Day 1) and Visit 2 (Day 28) subjects will be randomized to receive a     placebo ELLIPTA inhaler once daily (QD) or a placebo DISKUS twice daily (BID) with placebo     HandiHaler QD inhaler in 1:1 ratio in a cross-over manner for the study period (28 days for     each period). At Visit 3 (Day 56), subjects will be asked to complete preference     questionnaire 1 or 2. There will be no active treatment and subjects will continue to take     their own prescribed COPD maintenance and rescue medication during the entire study period.     ELLIPTA and DISKUS are the registered trademarks of GlaxoSmithKline group of companies.     HandiHaler is the registered trademark of Boehringer Ingelheim group of companies.   "
4462|NCT03227432|"     This research study is studying a combination of targeted therapies as a possible treatment     for multiple myeloma (MM).      The drugs involved in this study are:        -  Elotuzumab        -  Nivolumab        -  Pomalidomide        -  Dexamethasone   "
4463|NCT03227419|"     Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France,     affecting 0.3% of the general population. Without effective treatment, the persistent     inflammation causes invalidating pain and joint destruction, leading to major functional     disability.      Biological agents have been proposed for patients with RA who have the most severe form of     the disease and that are inadequate responder patients to conventional synthetic     Disease-modifying antirheumatic drugs (csDMARDs). TNF inhibitors (TNFi) are historically     proposed as the first biological DAMRD for inadequate responder patients to csDMARDs. A     diverse therapeutic arsenal has become available in recent years with the development of     non-anti-TNFα drugs whose mechanisms of action are different from the classical TNFi. This     new biotherapy class includes tocilizumab and abatacept, two drugs recently available for     subcutaneous administration that enables ambulatory care for patients who would otherwise     require repeated in-hospital care.      The role of these new treatments in the therapeutic strategy has been emphasized by studies     that demonstrated their efficacy as first-line treatments. However, in clinical practice,     TNFi remain the most common first-line treatment for the majority of patients, non-anti-TNFα     biological agents being reserved for inadequate responder patients.      In second line, several studies have investigated therapeutic strategies for inadequate     responder patients to TNFi. Current data suggest that it could be wise to change the     therapeutic target after failure of a first-line treatment with TNFi.      Data about the comparative efficacy of different biologics proposed after failure of a     first-line treatment with TNFi are in progress. Meta-analyses from registries and academic     trials conducted in France and The Netherlands suggest that non-anti-TNFα agents would have     equivalent or superior efficacy compared with a second TNFi. This finding suggests clinicians     to switch for an alternate therapeutic target after failure of a first-line TNFi.      Data comparing different non-anti-TNFα biologics in inadequate responder patients to TNFi are     scare. Industrial trials have demonstrated sustained biological efficacy of non-anti-TNFα     biologics after failure of a TNFi. However, there is very little solid data on the direct     comparison between them.   "
4464|NCT03227406|"     To further understanding of the relationship between sleep and memory the investigators will     address and attempt to answer three questions, (1) how memories evolve across wake and sleep,     (2) how different aspects of this memory evolution are reflected both behaviorally and in the     EEG signal, and (3) what stages and features of sleep affect memory evolution. Together,     these studies will provide a greater breadth and depth of knowledge concerning sleep's role     in memory consolidation. Such knowledge would be of practical importance for educational     practices, whether in schools, on the job, or in the military, and would also provide     valuable information to the fields of sleep medicine and psychiatry, where interactions     between sleep disorders and cognitive functioning are of great importance.   "
4465|NCT03227393|"     The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic     activity and subsequently cardiac arrhythmias.   "
4467|NCT03227367|"     The present study is an effort to investigate the hypothesis that Platelet Rich     Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation     and in bone loss.   "
4468|NCT03227354|"     Primary objective of this study is to assess the accuracy and precision of intracranial     pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid     hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive,     measurement.      Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement     in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous,     non-invasive measurement and standard, invasive,measurement   "
4469|NCT03227341|"     The investigators compared the effectiveness of pulmonary rehabilitation program on asthma     control in patients with uncontrolled and partially controlled asthma.   "
4470|NCT03227328|"     Prospective, open label, multicenter, randomized phase III study, comparing two strategies as     first chemotherapy-based treatment for locally advanced or metastatic luminal breast cancer.        -  Arm A: concomitant chemotherapy plus an aromatase inhibitor (AI); the AI must continue          until disease progression or toxicity or patient refusal; chemotherapy may be stopped          after achievement of maximum response (generally after at least about 3-6 months of          treatment) or in case of toxicity or patient refusal.        -  Arm B: chemotherapy followed by an AI at the time of progression to chemotherapy (if an          endocrine therapy is deemed indicated by the treating physician) or as maintenance          therapy after achieving maximum response to chemotherapy (generally after at least about          3-6 months of treatment) or after stopping chemotherapy for toxicity or patient refusal.   "
4475|NCT03227263|"     The recognized manifestations of HHT are all due to abnormalities of vascular structure.     Epistaxis and digestive arteriovenous malformations may be responsible for severe hemorrhages     in 5% of HHT patients, requiring repeated blood transfusions and are associated with high     morbidity. There is currently no standard and efficient management of this severe symptom. It     is also well known that HHT-associated hemorrhages have the greatest negative impact on     quality of life among HHT patients, and is responsible for anemia, blood transfusions,     hospitalizations, depressive syndrome and a high psycho-social impact.      Since 2006, it has been suggested by animal models and then by clinical reports that     anti-VEGF therapy may be useful to treat HHT. 4 case reports have been published on efficacy     of intravenous bevacizumab, a humanized monoclonal antibody in HHT on severe hemorrhages.      Intravenous bevacizumab has been used in a previous clinical trial to measure efficacy and     tolerance of this drug in HHT patients with severe liver involvement. Furthermore, a     reduction was observed in the duration of the nosebleeds after treatment and was encouraging     to treat bleeding. We completed this study by a pharmacokinetic-pharmacodynamic (PK-PD) model     in order to assess the individual concentration-effect relationship of bevacizumab.      However, no randomized prospective study has been performed and published to evaluate the     efficacy in this indication. A total of 24 patients will be randomized versus placebo in a     multicenter phase III trial. The Avastin or placebo will be infused at 5mg/kg every 14 days     with a total of 6 cures with a 3 months following period.   "
4476|NCT03227250|"     This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus     (Gpi) on freezing of gait in patients with Parkinson's disease.   "
4477|NCT03227237|"     Assess the impact of Strained Interpersonal Relationship (IPR) with parents on Juvenile     Delinquency among Children residing in Selected Delinquent Home Ambala, Haryana   "
4478|NCT03227224|"     The purpose of this study is to assess the dose-response relationship of 2 doses of     JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis     results, compared to placebo as adjunctive therapy to an antidepressant drug in improving     depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an     inadequate response to current antidepressant therapy with a selective serotonin reuptake     inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the     safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an     antidepressant in participants with MDD.   "
4479|NCT03227211|"     To develop predictive models for short-term readmission (60 days) and medium term (one year)     for patients with an exacerbation of COPD (eCOPD) which are admitted to any of the     participant hospitals. To identify factors contributing to readmission from the time of     discharge from the index admission to the studied readmission time. Methodology. Design:     Prospective cohort study with a nested case control study, with follow up to one year.     Patients: 1500 patients admitted over a year and a half in any of the 9 participant hospitals     by an eCOPD. Methods: During admission, background information on patient situation prior to     admission, data of the ED during admission, and discharge planning, will be collected from     medical history. We will also survey patients (generic and specific health-related quality     life -HRQoL- dependence, social support, presence of fragility). All patients will be     followed to determining whether any readmission until 60 and up to one year of discharge from     the index admission occurs. Patients readmitted at the first 60 days after discharge will be     surveyed on a number of possible causes of readmission (continuity of care, medication,     complications, individual and social factors). A one to one control group will be established     to compare different factors studied in the case group (readmission). Statistical analysis:     predictive models will be developed from the derivation sample, and validated in a validation     sample. Also, the factors evaluated in the case-control study will be compared using     appropriate test for paired samples.   "
6552|NCT03200119|"     In order to study the effectiveness of personalized healthcare intervention for     lifestyle-related diseases, investigators designed this study using mobile application and     clinical feedback from clinicians   "
4481|NCT03227185|"     Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex     (DLPFC) improved episodic memory performance, indicating a possible use as an intervention     for patients suffering from memory impairments. At the same time, only scant evidence     (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy     (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted     application.      The present study aims at establishing a connection between the stimulation-induced change in     episodic memory performance on the behavioural level and neurophysiological parameters. TDCS     effects and the underlying mechanisms will be compared between different study populations,     receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal     cortex during an episodic memory task.   "
4482|NCT03227172|"     The radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were     investigated by two radiologists using MRI, based on the same six criteria, to categorize the     lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded     to the radiologist's diagnoses) analyzed all specimens by referring to seven specific     parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater     agreements between the radiologists and pathologists in terms of MRI and histological     diagnoses, respectively, along with the discriminant power of the adopted criteria and the     accuracy of the MRI assessments compared with the histopathologic results, were calculated.      A strong inter-rater reliability was observed between the two radiologists (k-statistic =     0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was     higher for the radiological (Guttmann's lambda lower bound > 0.6) than histopathological     criteria. The accuracy (true positives plus true negatives) of the radiologists was higher     than that of the pathologists based on receiver operator characteristic analysis (area under     the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and     comparable to histopathological reliability, highlighting the usefulness of this non-invasive     exam as a pre-treatment diagnostic method for periapical endodontic lesions.   "
4926|NCT03221387|"     Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute     beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized.     The usefulness of this therapy in the outpatient setting is unproven. This pilot study will     test the feasibility of using this therapy in the outpatient setting and its effects on     sleep.   "
4483|NCT03227159|"     This is a national multi-center, prospective surveillance study in patients with suspected     acute coronary syndrome. Eligible patients must present to one of the participating Emergency     Departments within 24 hours from the time of symptom onset. Approximately 2000 patients >18     and <85 years of age are planned to be enrolled.      Upon enrollment in the Emergency Department, a venous blood sample will be obtained from each     patient for analysis. The patient's diagnostic work-up, treatment and disposition will     continue per the standards of the treating institution. Results will be recorded for ECGs,     any cardiac biomarkers measured at the site and any follow-up cardiac objective tests     performed for evidence of coronary artery disease and/or myocardial damage (exercise     treadmill, coronary angiography, cardiac thallium or technetium scintigraphy, etc).      The Principal Investigator at each site will evaluate the results of the diagnostic cardiac     tests performed for that patient to determine whether each patient enrolled at their site has     a final diagnosis of ACS.      The status of each patient will also be assessed at 1 month and 6 months after enrollment for     intercurrent Major Adverse Cardiac Events (MACE), including myocardial infarction, cardiac     revascularization and death.   "
4484|NCT03227146|"     This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin)     in comparison to meshed STSG in adult patients with partial deep dermal and full thickness     burns.   "
4485|NCT03227133|"     The study focuses on the identification of clinical, physiological and morphological markers     that could predict the response to antidepressant in elderly suffering from unipolar     depressive disorder.   "
4486|NCT03227120|"     The primary aim of this study is to determine the effects of pre-surgery exercise known as     Prehabilitation, on functional outcomes for patients following Total Knee Arthroplasty (TKA)     surgery. The hypothesis is patients that receive effective pre-surgery prehabilitation will     demonstrate improved recovery as measured by the 6-minute walk (6MW) test at one month post     surgery.   "
4487|NCT03227107|"     1. enrollment criteria and clinical data collection: follow the principles of medical          ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS          patients, in the active treatment at the same time, according to the Berlin standard          severity of the disease divided into mild group, moderate Group and severe group,          according to the prognosis during hospitalization is divided into survival group and          death group. BALF specimens were collected on the day of admission to detect the levels          of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ          (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen,          fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis,          oxygenation index; record the patient's mechanical ventilation time and other data;        2. Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage          coke death level was a positive correlation between the Spearman rank correlation          analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ,          Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and          ARDS severity was positively correlated;        3. To analyze the prognostic factors of different prognostic factors, to evaluate the          content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray          scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term          survival outcome prognostic value.   "
4498|NCT03226964|"     This study is a prospective randomised trial where a computer will randomly allocate      patients to one of two possible methods of delivering oxygen during the procedure of      bronchoscopy. This trial compares high flow nasal cannula (HFNC) with nasal prongs in      delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans-      bronchial nodal aspiration (EBUS-TBNA) a specialised form of bronchoscopy procedure.      HFNC uses humidified higher gas flow rates than conventional low flow systems such as      nasal prongs which are limited by the respiratory rate and effort.   "
4499|NCT03226951|"     Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the     progression of non central CSME to central CSME in compare to glycemic control   "
4904|NCT03221673|"     This is a cross-sectional study aiming to identify how daily activities affect children's     body fitness and general health. Also, the study will address how specific behaviors (such as     diet and sleep) as well as neighborhood and home environment affect children's metabolic     health and fitness level.   "
4488|NCT03227094|"     Cystic fibrosis (CF)-related diabetes (CFRD) is the most common complication after pulmonary     complications. This specific form of diabetes is associated with an increased morbidity and     mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while     another 35% of adult patients presents impaired glucose tolerance.      In order to identify patients at risk and to implement early therapeutic measures, an annual     CFRD screening test should therefore be undertaken for CF patients after 10 years of age. The     2-hour oral glucose tolerance test (OGTT) with a sweet beverage is the recommended screening     test. However, participation rates for screening tests are far from optimal. For examples, in     2015, the investigators observed that only 47% of non-diabetic patients attended to planned     screening despite large availability and advertisement (unpublished data). Comparable low     levels of screening for CFRD, usually below 33%, have been reported by various teams. Several     reasons could explain these low adherence rates. Some factors are related to patients     perceptions and experience: OGTT is perceived as an additional medical burden requiring a     scheduled appointment (several weeks after the last exacerbation); overnight fasting followed     by the intake of a large glucose load within 5 minutes can lead to nausea, headache, bloating     and fatigue; some patients fear multiple blood sampling, etc. In addition, in case of CFRD     diagnosis, recommended capillary blood glucose monitoring, nutritional advice and treatment     (insulin) are perceived as extremely invasive and complex, thus some patients prefer avoiding     screening test. To date, no alternative screening method has demonstrated its effectiveness     to screen for CFRD. The investigators of this study believe that a simplified version of the     OGTT would be more attractive, would make it more acceptable for patients and has the     potential to improve their adherence to screening tests, simplify CF-team works and reduce     costs. By allowing appropriate education and introduction of treatment in a timely manner,     improved adherence to annual screening for dysglycemia has the potential to minimize or     prevent clinical deterioration observed in years preceding CFRD onset.   "
4489|NCT03227081|"     The purpose of the study is to examine whether sleep affects the development of intrusive     memories.   "
4600|NCT03225638|"     The aim of this study is to evaluate the intramuscular nominal thigh injection performance     and the low threshold strength thigh injection (by evaluating 2 low threshold : upper limit     and lower limit). All participants will receive an intramuscular nominal thigh injection, and     half of the participants will receive an intramuscular low threshold (upper limit) strength     thigh injection, while the other half will receive an intramuscular low threshold (lower     limit) strength thigh injection.   "
4490|NCT03227068|"     After the initial hospitalization, parents of children newly diagnosed with cancer assume     responsibility for assessing and managing their care; however, parents are often overwhelmed     with information received throughout the hospitalization and are apprehensive about caring     for their child at home. Parents want concise, focused information on how to care for their     child after the hospital discharge. Two parent education discharge support strategies (PEDSS)     were created to use at hospital discharge. PEDSS consists of a symptom management     intervention and a support for the caregiver intervention. A cluster randomized control trial     will assess the effectiveness and feasibility of the two different interventions.   "
4491|NCT03227055|"     This 3-year study will systematically evaluate the prevalence, clinical symptoms, and     progression of CV and kidney disease and assess the impact of potential genetic,     pharmacological, behavior, and environmental risk factors in a prospective cohort with a     sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD).     Measurements of morphological (e.g., LVMI & cIMT) and functional characteristics (e.g., FMD &     PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points     for CV comorbidity in this study. Possible associations of these end points with multiple     molecular (ADMA & urine exosome miRNA), perceived value and behavior (EQ-5D-Y),     pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey)     will be explored.   "
4492|NCT03227042|"     This is a natural history study for children up to 18 years of age who have been diagnosed     with Mucopolysaccharidosis Type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B).     Mucopolysaccharidosis type IIIB is a severe neurodegenerative disorder. The information     gathered from this trial may help inform the design and interpretation of subsequent     interventional studies. No clinical intervention or study drug is provided by BioMarin in     this study.   "
4493|NCT03227029|"     The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the     recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L     or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants 6 to 24 months     of age.      This study is a companion study to CIR 321.   "
4494|NCT03227016|"     For this study sensitive or refractory SCLC patients (refractory to prior chemotherapy     defined as having experienced no response or a relapse within 90 days after the end of     chemotherapy) will be eligible. In total, around 130 patients will be enrolled, around 30     evaluable patients in phase I and 100 patients in phase II.      The study will consist of two parts:      A preceding Phase I part will be performed to identify the Recommended Dose of veliparib to     be administered in the Phase II part in combination with topotecan at the dose regimen of     1.25 mg/m2 (on days 1-5 of a 3 week cycle [d1-5q21d]). Each patient will be subjected to an     initial cycle of topotecan monotherapy (1.25 mg/m2 on day 1-5 of a 3 week cycle); this run-in     cycle shall prove topotecan tolerance of the candidates. Only patients who do not reveal any     DLTs receive further treatment with combination therapy. In a dose-escalating 3+3 design the     RD of veliparib for the subsequent Phase II part of the study will be defined during a     maximum of 5 cycles combination therapy.      The Phase II part will follow upon completion of Phase I.   "
4495|NCT03227003|"     The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne     RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food     frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation     Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays.      The investigators studied the association between nutrients involved in one-carbon metabolism     and DNA methylation in peripheral blood.   "
4496|NCT03226990|"     Forty completely edentulous patients were selected and randomly distributed into two groups     20 patients each.Group I received complete dentures constructed from elastomeric impression     with wax spacer,group II received complete dentures constructed from elastomeric impression     with no wax spacer.then on time of denture insertion pressure areas were detected using     pressure indicating paste and the denture retention was detected.The results showed less     pressure areas in group I and more denture retention values than group II.   "
4497|NCT03226977|"     In the past, several studies have compared the effects between nasal intermittent positive     pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the     incidence of intubation in preterm infants, and the results were inconsistent.The purpose of     the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation     and subsequent complications   "
4579|NCT03225911|"     The focus of this project is to determine the immediate efficacy of a combined treatment     (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and     the short term effect over 6 weeks. Secondly, to compare the effect of this combined     treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)   "
4500|NCT03226938|"     Understanding the impact of dietary patterns, exercise, and behavior change in the prevention     of disease is paramount to improving the health and well-being of future generations and     economies. A gap in the research is the lack of data on factors that predict successful     behavior change for sustained dietary practices chosen for health or other personal reasons.     To date, no survey exists that was designed to target persons following a wide range of     popular dietary patterns (e.g., Paleo, low-carb, vegetarian, vegan, Mediterranean,     gluten-free, etc.). These dietary patterns, which offer great variation in macronutrient     composition, are unique and unexplored in other similar surveys to date, making their     examination innovative. Adhering to Dietary Approaches for Personal Taste (ADAPT) will be the     first large cohort of its type that is focused on adherence to popular dietary patterns,     providing the opportunity to better understand how individuals can be supported to     successfully maintain a specific dietary practice, and, in the long-term, how these practices     may influence parameters of healthy aging.   "
4501|NCT03226925|"     Mechanical ventilation can be used to impose a completely regular pattern of breathing     frequency and inflation volume on the patient for as long as required. This would     considerably improve the reproducibility of the internal motion parameters, and thus     facilitate the implementation of respiratory-synchronized techniques such as gating, tracking     and four-digital optimization.   "
5301|NCT03216486|"     The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone     in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT     scanner. Participants will be treated for 1 year.   "
4502|NCT03226912|"     As mortality from critical illness has reduced, the importance of measuring disabilities     (cognitive, functional and psychological) in surviving critically ill patients has become     more important. Currently, the causes, long-term effects and frequency of disabilities in     patients surviving ICU in Australia are unknown. In the US and UK, studies have been     undertaken to assess the effects of specific long-term outcomes, such as functional     disability and depression, which found long-term disabilities were much higher than baselines     (pre-illness function) and ongoing at five years after ICU discharge. In order to improve     quality of life of ICU survivors and ensure that medical specialists apply appropriate     interventions to reduce the cost of these surviving patients on the community, the PREDICT     management committee proposes the introduction of a patient-reported outcomes registry.   "
4503|NCT03226899|"     This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a     placebo plus an XOI in gout participants who have moderate renal impairment and who are not     at target level of sUA.   "
4504|NCT03226886|"     This is a translational study, which, aims to develop prognostic and predictive biomarkers     for patients with renal cell carcinoma (RCC).   "
4505|NCT03226873|"     This pilot study will assess the feasibility and acceptability of a peer outreach and     navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis     (PrEP) uptake among street-based cisgender and transgender women involved in transactional     sex.   "
4506|NCT03226860|"     This research study will see if electrical stimulation increases heel strike (heel hits the     floor first when walking), decreases limp, helps muscle contraction, and improves balance in     children with a hemiplegic leg. An experimental electrical stimulation device called the Gait     MyoElectric Stimulator (GMES) will be used to stimulate the shin and calf muscles.   "
4507|NCT03226847|"     Pulmonary vein isolation (PVI) has become a common and effective treatment for paroxysmal and     persistent atrial fibrillation (AF), particularly in patients with drug-refractory disease.     Intense endurance exercise is a known risk factor for atrial fibrillation. In general, these     athletes poorly tolerate most common antiarrhythmic drugs used for atrial fibrillation     control and often PVI is recommended for durable management. While the efficacy of PVI in     athletes is similar to the general AF population, some athletes with lone atrial fibrillation     report a reduction in subjective exertional capacity following PVI, despite maintenance of     sinus rhythm and absence of pulmonary vein stenosis on imaging. The investigators hypothesize     that PVI may alter pulmonary vein function and affect peak exercise performance.      The investigators propose a small, prospective study of endurance athletes undergoing antral     PVI for treatment of lone atrial fibrillation. Peak metabolic performance and pulmonary vein     function will be assessed pre- and post-PVI by metabolic stress testing and cardiac MRI,     respectively.   "
4508|NCT03226834|"     Anxiety is a psychologic and physiological state that could be characterized by somatic,     emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an     anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to     negative physiological signs that slow down healing, lowers imune response and increases     post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality.     Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of     alternative treatment such as musicotherapy has been demonstrated in several randomized     control trials. Nevertheless, most of these studies have investigated the effect of     musicotherapy in groups with our without musical listening.      In the present study, investigators assume that a personal musical sequence composed by     favourite songs of the patients could have beneficial effect on presurgical anxiety than     selective sequence of the medical device MUSIC CARE.      In this study, the anxiolytic effect of predefined U musical sequences that alternate slow     and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in     women with planned gynecological surgery.   "
4509|NCT03226821|"     In this study, the investigators will examine the effect of therapy with the Growth Hormone     Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV     lipodystrophy and central adiposity. This study is a single arm prospective study of     tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition     testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity     assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous     injection.   "
4510|NCT03226808|"     The objectives of this study are to obtain clinical performance (outcomes) data and     survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by     analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported     adverse events data.   "
4703|NCT03224299|"     Objective of this study is to compare the antimicrobial properties of an investigational     agent to an active control and a negative control when applied to specific body locations.     Testing will be performed according to the procedures outlined in the Food and Drug     Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient     Preoperative Skin Preparation   "
4511|NCT03226795|"     Background Cystic fibrosis is a life-threatening genetic disorder responsible for pulmonary     failure and multi-systemic complications involving specific and large medical care burden. To     date, no program has shown its effectiveness in improving therapeutic adherence. A new     approach to develop a co-constructed program involving patients and professionals may     contribute to improve therapeutic adherence.      Objectives The aim of the MUCOBS-Trial project is to create a program to increase therapeutic     adherence and to evaluate its efficacy in adult patients with cystic fibrosis in 3 CF centers     in France.   "
4537|NCT03226457|"     The RECEDE-CHF trial is a single centre phase IV, randomised, double-blind,     placebo-controlled, crossover trial conducted in NHS Tayside, Scotland comparing     empagliflozin 25mg, to placebo in patients with Type 2 Diabetes and mild Chronic Heart     Failure with left ventricular systolic dysfunction who are already on a loop diuretic. Renal     physiological testing will be performed at two points on each arm to assess the effect of     empagliflozin, on urinary volume, compared to placebo. The secondary outcomes are to assess     the effect of empagliflozin in addition to loop diuretics on natriuresis, to assess the     safety of add-on SGLT2 inhibitor therapy as measured by changes to serum creatinine and eGFR,     to assess effects of empagliflozin on urinary protein/creatinine ratio, albumin/creatinine     ratio and cystatin C when compared to placebo.   "
4512|NCT03226782|"     Among the possibilities of intervention to minimize the effects of cancer treatment, the     exercises are efficient in improving the physical fitness and quality of life of the elderly     in treatment. The goal is to compare the effects of two home physical exercise protocols on     quality of life and physical fitness of elderly people with breast cancer who are in hormone     use. A study was carried out at the Institute of Integral Medicine Professor Fernando     Figueira (IMIP) within the Professional Master Program in Palliative Care Associated with the     Residency Program in Health, which evaluated the effectiveness of a protocol of 29 exercises     with walking sessions, performed at home , In the quality of life and physical fitness of the     elderly in the treatment of breast cancer. The results of the mentioned research showed that     the elderly showed improvement both in quality of life and physical fitness.      In view of the results and the clinical and functional kinetic observation of these patients,     the hypothesis was that a shorter intervention protocol, with fewer exercises with fewer     repetitions and a lower degree of difficulty can bring results similar to those found,     requiring a shorter time In the accomplishment of the exercises, which can favor the     adherence to the protocol by the patients, still achieving positive results in their quality     of life and physical fitness.      The elderly will undergo evaluations to characterize the sample through questionnaires, the     physical fitness assessment will be performed through the Senior Fitness Test (SFT) and     anthropometric evaluation before (beginning of the research), in the 6th week and after the     12th week of the research. It will be offered the elderly, instructional material developed     for this research - printed manual. It will consist of a routine of 12 exercises to be     performed autonomously for range of motion and muscular fitness, using the environmental     resources of the home. All control and training guidelines for using the manual will be     offered through an introductory lecture and subsequent weekly telephone contacts (twice a     week). Participants should complete their respective program for a total period of 12 weeks     and mark in the manual how often they performed the exercises. The control group used a     protocol with 29 home exercises in a longer manual. The results will be obtained from the     statistical package SPSS 10.0 for Windows and a p <0.05 will be accepted.   "
4513|NCT03226769|"     This study will compare the safety and efficacy of TrueTear to standardized moist heat     compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).   "
4514|NCT03226756|"     Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common     clinical situation and although this group of patients has very heterogeneous disease     characteristics, they share a dismal prognosis with a median survival time around 6-11 months     and a relatively poor quality of life.      Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty     cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC)     and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for     recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361     patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this     condition and whose disease had progressed within 6 months after platinum-based chemotherapy.     In this study, treatment with nivolumab resulted in significantly longer survival than     treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months     (p=0.01).      The main objective of the study is to provide additional insight into the frequency of     high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety     database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head     and neck patients.   "
4515|NCT03226743|"     The aims of COMET are the implementation and evaluation of effectiveness and     cost-effectiveness as well as processes of a collaborative and stepped care model for     depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional     network in comparison to routine care. In a cluster-randomized controlled effectiveness trial     750 patients will be recruited by 50 general practitioner practices and followed with a     prospective survey at four time points. The primary outcome is the change in health-related     quality of life from baseline to 12-month follow-up. Secondary outcomes include     disorder-specific symptom burden, response, remission, functional quality of life,     cost-effectiveness, evaluation of processes and other clinical and psychosocial variables.   "
4516|NCT03226730|"     This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and     qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents     (RMA) Interventions developed and implemented by Pathfinder International to increase     contraception use and contraception use intentions among married adolescent girls ages 13-19     in three rural districts of the Dosso region of Niger. Intervention models     (gender-synchronized household visits and small groups) will be tested using a randomized     4-arm outcome evaluation design; Arm 1 will receive household visits, Arm 2 will receive     small groups; Arm 3 will receive household visits plus small groups, and Arm 4 will serve as     the control group and will not receive any intervention. The quantitative component will     consist of collecting quantitative baseline and 16-months follow-up survey data from randomly     selected married adolescent girls (n=1200) and their husbands (n=1200) who are participating     in each Arm of the study. Qualitative elements will include ethnography at two time points     and semi-structured in-depth interviews half way through intervention implementation. A     costing and cost effectiveness analysis will also be conducted to evaluate which intervention     provides the largest gain in the primary outcomes for each dollar spent.   "
4523|NCT03226639|"     The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning     intervention. It allows a long-term treatment of this arrhythmia with a success rate of about     80%. There are, nevertheless, some recidivism.      Risk factors for recidivism are poorly codified and need further research. Indeed the     identification of factors of poor prognosis could lead to not propose this procedure to the     patients who present them and at least to inform them of an increased risk of failure.      To date, aortic stiffness has not been studied in the context of assessing the risk factors     for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads     to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic     dysfunction and increased left atrial size. That may constitute a substrate for FA     recurrence.      In the literature, aortic stiffness can be measured in several ways:        1. Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner          or transesophageal Echography (ETO).        2. Measuring of the Pulse Wave Velocity.        3. Measurement of aortic calcifications.      The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA     6 months after ablation procedure performed in the Croix-Rousse cardiology's department.   "
4538|NCT03226444|"     The objective of this study is to evaluate the efficacy and safety of two strengths of     Lacripep™ ophthalmic solution versus placebo administered three times daily for four weeks in     subjects with a diagnosis of Dry Eye associated with documented Primary Sjögren's Syndrome   "
4539|NCT03226431|"     To treat an intermediate size patient population of bilateral lung transplant patients with     CLAD-0.   "
5302|NCT03216473|"     This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in     adults with essential blepharospasm.   "
4517|NCT03226717|"     The prevalence of HCV infection in Egypt is 14.7%. HCV is both a hepatotropic and a     lymphotropic virus, it may exert a chronic stimulus on the immune system with both T and B     lymphocyte alterations. In addition to cryoglobulinaemic vasculitis, HCV may trigger     different immune-mediated extrahepatic disorders. A variable combination of HCV with other     unknown enviromental and/or hostgenetic cofactors may lead to different clinical phenotypes     that characterise HCV syndrome. Patients who have HCV -related arthropathy are accounted for     by 2 clinical subsits: Rheumatoid-like arthritis and Cryoglobulin-related arthritis. Patients     with mild arthritis, conservative manegement using analgesics with anti- inflammatory     activity is recommended. In patients who have contraindications to their use, short term low     dose prednisone is an option. In HCV infection with concomitant RA, ACR guidelines published     in 2008 provided recommendations pertaining to these of DMARDs that are based on the severity     of liver disease using the child- pugh- turcotte classification. For patients with severe     cryoglobulinaemia such as severe debilitating disease or systemic in improvement, a     combination of immunosuppressive and antiviral therapy is preferred. It has been found that     antiviral therapy with interferon immunosuppressive and antiviral therapy is preferred. It     has been found that antiviral therapy with interferon improves the musculoskeletal     manifestations in HCV arthropathy. The DIrect antiviral agents seems very promising in     treatment of HCV arthropathy. As HCV genotype 4 is the most common genotype in Egypt, the     effective optional antiviral agents are sofosbuvir, daclatasvir, ledipasvir, paritaprevir,     velpatasvir, ombitasvir and simeprevir.   "
4518|NCT03226704|"     Background:      Leukapheresis is a procedure to separate and collect white blood cells. It is the first step     in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be     offered to people when their cancer comes back. The collected T-cells are used to make a     special version of T-cells called CARs. Researchers want to collect these cells from people     who may become eligible for a CAR T-cell study in the future.      Objective:      To identify people who have a high likelihood to benefit from CAR T-cell therapy early in     their disease course and collect and store a T-cell product.      Eligibility:      People ages 4-30 with a form of leukemia or lymphoma that has not been cured by standard     therapy      Design:      Participants will be screened with medical history, physical exam, and blood and urine tests.     Some will also be screened with:      X-rays      Scans      Spinal fluid samples      Bone marrow aspiration and biopsy      On this study, participants will have leukapheresis. A needle will be placed into the arm.     Blood will be collected and go through a machine. White blood cells will be taken out by the     machine. The plasma and red cells will be returned to the participant through a second needle     in the other arm. The procedure will take 4-6 hours. Some participants may have a central     line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the     needles in the arms-especially if they are smaller. For a central line placement, a long thin     tube is inserted through a small incision into the main blood vessel leading into the heart     that would allow access to the blood to do the leukapheresis procedure.      Participants cells will be processed and frozen for future use in a CAR T-cell therapy study.   "
4519|NCT03226691|"     The constitution of blood relies upon hematopoietic stem cells (HSCs), which stay in the bone     marrow and differentiate to all lineages of peripheral blood cells. HSC transplantation is     the only curative option currently available for sickle cell disease (SCD) patients either     via allogeneic HSC transplantation or HSC-targeted gene therapy. Granulocyte-colony     stimulating factor (G-CSF)- mobilized HSCs are frequently utilized in the adult setting of     HSC transplantation because of the faster hematologic recovery as compared to bone marrow. As     an autologous HSC source for gene therapy, bone marrow harvest has been generally employed     since G-CSF has been prohibitive in SCD patients due to granulocyte stimulation and the     associated reports of vaso-occlusive crises, multi-organ failure, and death. However, when     bone marrow harvest is used, the amounts of collected cells are limited and anesthesia is     required. In order to obtain HSCs in large numbers without anesthesia, patients will undergo     mobilization followed by large volume apheresis. Plerixafor is an alternative treatment for     mobilization without direct stimulation to granulocytes, and it is theoretically applicable     for SCD patients. The primary endpoint of this study is to obtain sufficient amounts of HSCs     collected from the peripheral blood in SCD patients after plerixafor      mobilization with an acceptable safety profile. The harvested products will be stored as     backup for patients undergoing gene therapy as well as allogeneic HSC transplantation....   "
4520|NCT03226678|"     This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics     of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease     (CAD).   "
4521|NCT03226665|"     Small bowel obstruction (SBO) is a common presentation to the emergency department (ED) and     represents 15% of hospital admissions for acute abdominal complaints.      Plain radiography, although traditionally recommended as the initial diagnostic imaging     modality of choice, has a sensitivity of only 59% to 77%. When clinical and radiographic     assessment is indeterminate, computed tomography (CT) becomes the test of choice due to its     superior resolution and increased ability to identify both obstruction and its aetiology Aim:     this is a prospective study in a sample of patients presenting to the emergency department     (ED) with abdominal pain, vomiting, or other symptoms suggestive of a SBO (history of     previous surgeries, constipation, abnormal bowel sounds, and abdominal distention). Patients     will be evaluated with US prior to x-ray and CT, with possible diagnostic confirms by     endoscopy or surgery.   "
4522|NCT03226652|"     This study aims to determine the prevalence and prognosis of heart failure with preserved     ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).   "
4524|NCT03226626|"     This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic     delivery:      Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug     Administration (FDA) has approved our Investigational New Drug (IND) application to conduct     this RCT. An IND application was necessary because subcutaneous injection of antibiotics in     general, and cefazolin and metronidazole in particular are considered to be off-label. In     addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a     dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate     (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also     considered off-label.   "
4525|NCT03226613|"     Background: The incidence of human papilloma virus-driven oropharyngeal cancer (HPV-OPC), a     type of head and neck cancer, is rapidly increasing within the US. Currently, there are no     screening methods for early detection. HPV16 E6 antibodies combined with ultrasound imaging     may be a promising method for early detection of HPV-OPC. However, prior to testing HPV16 E6     antibodies and ultrasound for HPV-OPC screening, larger studies are needed to further     validate the utility of these methods in the diagnostic setting among patients with suspected     and/or symptomatic HPV-OPC.      Objective/Hypothesis: To investigate two promising screening modalities for the detection of     HPV-OPC, transcervical ultrasound and HPV16 E6 antibodies. The investigators hypothesize that     both ultrasound and HPV16 E6 antibodies will be highly sensitive for the detection of     symptomatic HPV-OPC.      Specific Aims: (1) Determine the sensitivity of ultrasound to characterize OPC tumors     compared to current standard imaging modalities among patients with suspected or confirmed     OPC. (2) To determine the sensitivity and specificity of HPV16 E6 antibodies for HPV-OPC. (3)     Determine the sensitivity of ultrasound to detect HPV-OPC compared to current standard     imaging modalities among patients that present with a neck mass and unknown primary tumor.   "
4526|NCT03226600|"     The purpose was to compare root coverage outcomes between autogenous connective tissue graft     (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.   "
4527|NCT03226587|"     Ultraviolet light exposure was shown to be able to release nitric oxide from the skin into     the blood stream and lead to an acute decrease in blood pressure and increase in vascular     function. Additionally, preliminary work indicates that UV free blue light also releases     nitric oxide in the skin mediating similar effects as seen with ultraviolet light A(UVA). It     is the goal of the present experimental study to investigate the hemodynamic effects of whole     body blue light exposure including blood pressure, endothelial function and vascular     stiffness. Therefore, healthy volunteers will be exposed to 30 minutes whole body blue light     (453 nm wavelength) and the change in blood pressure and endothelial function (Flow mediated     dilation (FMD)), heart rate, forearm-blood flow, forearm vascular resistance central blood     pressure and vascular stiffness ( pulse wave analysis by sphygmocor) will be measured.      In this randomized controlled cross-over study, 20 healthy subjects aged 30 to 60 years will     participate.   "
4528|NCT03226574|"     The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult     subjects with intractable pain associated with cancer in any area below the mid-thoracic     level who meet all other eligibility criteria.   "
4529|NCT03226561|"     Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses     implantation are supposed to have sufficient uncorrected vision capacity for activities of     daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is     known that light intensity and temperature has a great impact on near vision capacity.     Primary objective of this study is to identify the optimal task lighting conditions (in terms     of light intensity and temperature) for ADLs that demand near vision acuity for a sample of     patients who underwent presbyopic correction with bilateral trifocal intraocular lenses     implantation   "
4530|NCT03226548|"     Paycheck Plus (PP) is a randomized controlled experiment (RCT) that explores the health and     longevity effects associated with increasing the Earned Income Tax Credit (EITC). EITC is a     national program that provides tax credits to low-income, disproportionately minority workers     who file taxes. EITC is politically popular, having received bipartisan support. The EITC,     along with state supplemental programs, have 7 million American families out of poverty. The     investigators' preliminary data analyses show that the EITC has had large population health     impacts, reversing declines in self rated health and survival among the poorest Americans.   "
4531|NCT03226535|"     The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved     Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time     ultrasound that is being performed on the patient. This fusion system will be used to perform     ultrasound guided needle placements for patients undergoing percutaneous CT guided     needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM     SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is     to prove that the new imaging fusion system is comparable to using either CT or US guidance     alone to guide needle placement.   "
4532|NCT03226522|"     This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the     efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's     disease.   "
4533|NCT03226509|"     Several factors are barriers to effective Hepatitis C care: 1) The majority of Hepatitis C     Virus (HCV)-positive patients (45-85 percent) are unaware that they are infected; 2) Only a     small minority of those in need of treatment receive it; 3) Members of minorities and older     patients are even less likely to receive needed care; and 4) Until recently, even those who     were treated had a low chance of clearing the virus or achieving cure; 5) It is possible that     older attitudes and expectation of futility might continue to persist among patients and     provider in primary care settings.      Community Health Centers are often the most culturally appropriate and accessible choices,     particularly for underserved populations, with the benefit of ongoing trust and relationships     with patients. Therefore, these can be ideal places to deliver complex HCV care if they     possess the needed expertise. However, most community-based primary care and community health     centers lack access to Hepatitis C evaluation and treatment services, leading to a major     public health problem.      Thus, investigators propose to implement and evaluate a pragmatic trial to implement and     evaluate a multi-disciplinary model for HCV treatment at Currently, the treatment initiation     rates at each of these sites is estimated as less than 10%. The investigators hypothesize     that our project will increase the rate of participation in all the steps of the HCV care     cascade and ultimately lead to more than doubled rates of treatment uptake   "
4534|NCT03226496|"     The aim of the proposed supplemental study is to test a single session motivational     interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk     young Black men who have sex with men (YBMSM) and to determine whether previous assignment to     study condition moderates these outcomes.   "
4535|NCT03226483|"     INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate     after the surgical resection of brain metastases. Patients won't receive further radiation     therapy of the intraoperatively treated lesion.   "
4540|NCT03226418|"     This phase II trial studies how well cytarabine and idarubicin or decitabine work in treating     patients with acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in     chemotherapy, such as cytarabine and idarubicin, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Decitabine may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving patients cytarabine and idarubicin or decitabine may     work better in treating patients with acute myeloid leukemia or high-risk myelodysplastic     syndrome based on clinicogenetic risk stratification.   "
4541|NCT03226405|"     The MGH Cancer Center's patient navigation (PN) program, utilizes specially trained     community-based personnel to improve cancer care in underserved communities by increasing     cancer screening and removing barriers to timely care. This program incorporate rigorous     evaluation to demonstrate the impact of innovation in healthcare delivery.   "
4542|NCT03226392|"     A randomized, multicenter, double-blind, placebo- controlled parallel-group study to     determine the efficacy and safety of QAW039, compared with placebo, when added to     standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with     uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1     second (FEV1) at the end of 12 weeks of treatment.   "
4543|NCT03226379|"     The DREAMM project is investigating whether point of care tests within a diagnostic and     treatment algorithm together with support and additional training of laboratory and clinical     staff will reduce two and ten week all-cause mortality of HIV-associated meningo-encephalitis     in LMICs.   "
4544|NCT03226366|"     Sepsis is a common syndrome resulting from a dysregulated response to infection. The timing     of antibiotic initiation is an important determinant of outcomes for patients presenting to     the emergency department with sepsis. The potential effect of care reorganization on very     early care for sepsis is unknown. This study will investigate whether multidisciplinary     coordination of the initial patient evaluation in the emergency department influences     door-to-antibiotic time for septic patients.   "
4545|NCT03226353|"     The objective of the study is to determine if habitual or adapted contact lens wearers of     Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one     week of daily wear.      The primary outcome variables for this study are:        -  Investigator responses to refit questions;        -  Lens fit.   "
4546|NCT03226340|"     Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and     S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled     With CCB(Calcium Channel Blocker) Monotherapy   "
4547|NCT03226327|"     This study is an one arm, self-controlled preliminary trial. Hypertension patients will be     categorized into three types, not taking antihypertension drugs with normal renal function,     taking antihypertension drugs with normal renal function, and taking antihypertension drugs     or not with abnormal renal function. Each category includes 30 hypertension patients. Based     on renal function, the investigators provide the ManLiKang containing potassium chloride to     patients with normal renal function, and provide the ManLiKang not containing potassium     chloride to patients with abnormal renal function. All hypertension patients will use the     formula salt with limited sodium ManLiKang in six weeks, and will be followed up at 1, 2, 4     and 6 weeks to assess the safety, the effect of reducing blood pressure and the change of     24-hour urine sodium.   "
4548|NCT03226314|"     In its report dated april 2014, World Health Organization confirms antibiotic resistance     dissemination in all parts of the world, in hospitals and in community and worries about a     possible comeback to a pre-antibiotic era during the 21st century. For the last 15 years,     third-generation cephalosporins resistant enterobacteriaceae (3GCREB) prevalence is     continuously increasing. Community 3GCREB prevalence has not been studied whereas several     observations made in Reunion Island hospital suggest a diffusion in community. In this     situation of world-wide and regional extension of bacterial resistance, the investigator     offers to study bacterial resistance to antibiotic in Reunion Island community.   "
4549|NCT03226301|"     The aim of the current trial is to evaluate if combination treatment with venetoclax +     ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can     lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients     randomized to stopping treatment after 15 induction cycles.   "
4566|NCT03226080|"     Surgical repair of hip fractures may be performed with various anesthetic techniques, but are     most commonly completed under general anesthesia (GA) or neuraxial anesthesia (NA). Numerous     prospective and retrospective studies demonstrate improved morbidity and mortality when NA is     used; however, many surgeons prefer the use of GA with neuromuscular blockade (NMB) due to     the perception of better operative conditions. This study aims to compare the operative     conditions obtained from the use of combined GA and spinal with NMB vs. the use of GA with     spinal without NMB. 84 patients will all receive a single shot spinal and GA and then will be     randomized to receive either NMB or placebo. The fracture reduction time will be measured.   "
7164|NCT03192098|"     A randomized controlled prospective clinical trial assessing the efficacy and safety of     progressive esophageal dilation compared to conservative esophageal dilation in patients with     severe benign esophageal strictures.   "
4580|NCT03225898|"     The American College of Sports Medicine (ACSM) recommends that resistance exercise performed     at greater than 70% one repetition maximum (1 RM) is necessary to induce strength gains and     muscular hypertrophy (ACSM, 2009). However, previous work has shown resistance exercise at     high intensity increases the rate of injury. Blood flow restriction (BFR) exercise is a     method that is used to compress the blood vessels to the exercising muscle in order to reduce     blood flow to the limb with the use of low-intensity resistance. Researchers have suggested     that resistance exercise at intensities as low as 20-30% 1-repetition maximum with BFR     increases in muscle mass, muscular endurance, and gains in strength. However, the acute heart     and blood vessel changes in response to BFR are not clear. Work by our laboratory (Tai et     al., 2016) has demonstrated that immediately following acute resistance exercise at moderate     intensity (75% 1 RM) without BFR, there are no changes in aortic and brachial systolic and     diastolic blood pressure (BP), but there are increases in the pressure of the reflective wave     (augmentation pressure). This suggests that the arterial wall is stiff, and may in turn     result in thickening of the arterial wall. However, the data are limited and these responses     may not be universally accepted. In addition, these studies used primarily lower-body     resistance exercises (squat, leg extension, and leg flexion), and did not assess changes in     heart and blood vessel function. Previous researchers have demonstrated that upper-body     exercise induces higher BP and heart rate (HR) than lower-body exercise. However, the effects     of upper- and lower-body resistance exercise with BFR on heart and blood vessel function are     still unclear. Therefore, understanding the effects of upper- and lower-body resistance     exercise with BFR on heart and blood vessel function using weight machines, specifically the     chess press, latissimus dorsi pulldown, knee extension, and knee flexion may significant     impact how the resistance training program is prescribed.   "
4550|NCT03226288|"     While human body receives large external force or motions, minor injuries to the soft tissues     will be produced and will lead to acute or chronic inflammation reactions. Plantar fasciitis     is the most common foot diseases in normal population. Plantar fascia is a tight band-like     soft tissue that crosses between the bony surfaces of the bottom of the foot with thick     ligament-like structure substantially. Various reasons will induce the happening of plantar     fasciitis including native bone structure, aging, athletic motions and injuries. Indeed,     diagnosis of chronic heel pain remains challenging due to the complex structures of the foot.     Therefore, it is widely accepted that diagnostic imaging such as ultrasound and computed     tomography offer important orthopedic information for clinical assessments of soft tissues     and bone. Even though there is no single treatment shows the highest level of evidence for     plantar fasciitis, wearing of insoles or orthotics are highly suggested for clinical therapy.     Common custom-made insoles are manufactured with polymeric materials based on standing     foot-pressure distribution. However, this method strongly depends on experience of doctors or     physical therapists and usually time-consuming. In addition, modern medical researches tend     to combine the information of both soft (pressure distribution) and hard (orthopedic) tissues     for designing of orthotics and other medical assistive devices because of the complicity of     the limb motion and structures. Therefore, investigators aim at developing integrated 3D     system that provides a 3D limb data model with high-resolution appearance scanning and     orthopedic information for designing of medical assistant devices. This model composes of 3D     surface scanning, 3D bony structure scanning, and soft tissues characteristic mechanical     properties. By developing this system, the 3D model is also highly applicable to the other     parts of human assistant devices. It will bring the enormous impact to the associated medical     field and create excellent economic value.   "
4551|NCT03226275|"     This is a Phase I, open-label, randomized, 2-period, 2-sequence, crossover study to     demonstrate bioequivalence (BE) between the bisoprolol-amlodipine fixed-dose-combination     (FDC) tablet (investigational product) and bisoprolol and amlodipine tablets administered     concomitantly (comparators) given as a single oral dose in fasting and fed state.   "
4552|NCT03226262|"     This is a prospective, observational, multi-center, single-arm, clinical trial designed to     assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to     Invasive FFR for diagnosing hemodynamically significant coronary stenosis.   "
4553|NCT03226249|"     The purpose of this research study is to evaluate a new drug Pembrolizumab in combination     with chemotherapy, for the treatment of newly diagnosed Hodgkin lymphoma. The chemotherapy     regimen is called ?AVD? and includes three drugs: adriamycin, vinblastin, dacarbazine.     Pembrolizumab is currently FDA approved for the treatment of some patients with melanoma,     lung cancer and head and neck cancer, but has not yet been approved for the treatment of     Hodgkin Lymphoma. The ?AVD? regimen of chemotherapy is currently FDA approved for the     treatment of newly diagnosed Hodgkin lymphoma, but has not yet been investigated in     combination with pembrolizumab for this disease. For patients who have a new diagnosis of     Hodgkn?s Lymphoma, multi-agent chemotherapy is recommended. Also, for patients who do not     have a complete response to chemotherapy (meaning there is still evidence of disease on PET     scans performed at the end of treatment), radiation is sometimes recommended. Furthermore,     the rare patient who relapses after chemotherapy requires treatment with high dose     chemotherapy and a transplant.   "
4554|NCT03226236|"     Single center, open-label Proof of Principle phase II trial to assess objective response     (ORR).      Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of     5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and     the third cycle of vaccine+IL-2. The first day of administration of vaccine is day +1 and of     IL-2 is day +2.      Treatment vaccine plus IL-2 (dose 18 MIU/m2/day in 500cc by continuous IV infusion for 72     hours) will be administered every 3 weeks up to 6 cycles.      Total duration of the trial: 36 months        -  Enrolment period: 24 months        -  Treatment: maximum of 6 cycles (5 months) per patient        -  Follow-up every three months until patient died (follow-up until PD and only survival          contacts and subsequent therapy for metastatic disease after PD).   "
4555|NCT03226223|"     This investigation will be the first study assessing genetic modulation of naltrexone's NTX     effects upon the abuse liability of a stimulant drug (methamphetamine). The study team will     assess the ability of oral NTX to block the reinforcing and positive subjective effects of     intranasal (IN) methamphetamine (30mg/70kg). This investigation could identify an important     Gene x Pharmacological interaction, contributing to the personalization of stimulant abuse     pharmacotherapy.   "
4556|NCT03226210|"     To compare the effect of the rapid-acting insulin analogues (RAIAs) NovoRapid (aspart) and     Prandilin (lispro) on glycemic variations by Continuous glucose monitoring system (CGMS) in     continuous subcutaneous insulin infusion (CSII) with metformin intensive therapy in newly     diagnosed type 2 diabetes mellitus (T2DM).   "
4557|NCT03226197|"     Every year, efforts are made to resuscitate about 30,000 people when their hearts stop     outside of the hospital environment ('out-of-hospital cardiac arrest'). Early damage to the     brain due to 'oxygen starvation' (seemingly paradoxically) gets worse when blood flow is     restored. Of the 6,350 survivors admitted to intensive care units, 46% die from brain damage,     and half of those who survive suffer long-term brain damage. Apart from avoiding a high     temperature, nothing has been found which can protect the brain or improve outcome.      'Ketones' are chemicals naturally produced in the body from fat during starvation. They act     as an energy source, but also as regulators of metabolism, and appear to protect cells from     damage when oxygen supplies are scarce, or when blood flow is restored. The investigators     want to see whether a ketone drink will protect the brain after out-of-hospital cardiac     arrest.      The investigators will study 10 cardiac arrest patients, and participants will be given the     ketone drink via a feeding tube (which is routinely passed into the stomach in such cases).     The investigators shall check that the drink is absorbed, and measure the ketone levels in     the blood. The investigators will also measure important aspects of blood chemistry     (including pH and blood sugar) and collect data on brain (electrical recordings called 'EEG'     and 'SSEP') and heart function (ultrasound scans or 'echocardiographs') - both of which it is     hoped might improve - in order to demonstrate that this is possible if it is to be included     in a subsequent large trial. The study will be scrutinised by world experts in the field, who     have also helped design the study.      If this pilot study is a success, the investigators will apply to a major grant body to fund     an appropriately-powered randomised controlled trial to determine whether ketones improve     neurological outcome and survival in these patients. Results will also allow similar studies     to be planned in heart attack, stroke and traumatic brain injury.   "
4567|NCT03226067|"     The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with     Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA)     treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase     (ALP).   "
4577|NCT03225937|"     This is a Phase II multi-center 2-sequential cohorts trial, designed to assess the objective     response rate of two anti HER2 combination in advanced disease CRC patients harbouring an     amplified HER2 tumor assessed according to HERACLES Diagnostic Criteria by FISH/SISH.      Cohort A: monoclonal antibody trastuzumab, used in combination with the small molecule     tyrosine kinase inhibitor lapatinib.      Cohort B, monoclonal antibody pertuzumab, used in combination with the antibody drug     conjugate trastuzumab-emtansine.      Please note that cohort A accrual has been closed and endpoint already reached.   "
4558|NCT03226184|"     Background:      Even today, postoperative infection is the commonest complications after surgery although all     aseptic precautions are taken and causes significant postoperative morbidity, mortality,     prolongs hospital stay, and increases costs. Infections that are related to orthopaedic     procedures are considered particularly severe when implantation materials are used which     further increases the risk of infection and holds the risk of biofilm formation. This is of     particular concern since biofilm-mediated infections are difficult to diagnose and effective     treatments are lacking. Therefore, new strategies for implant infection are currently being     researched worldwide. In this study the relatively new approach for infection control by     using an Er:YAG laser was adapted to an orthopaedic and traumatologic setting. This laser     vaporizes all water containing cells in a very effective, precise and predictable manner and     shows only a minimal thermal damage.      Methods:      For preliminary testing 42 steel pins and 42 plates were cultivated with cocultures for 2     weeks. The minimally necessary laser energy for biofilm removal was determined. We     subsequently compared the effectiveness of biofilm removal with the Er:YAG laser and a     cleansing of the metal implants with Octenidine soaked gauze. The temperature rise within the     metal during the laser procedure was also measured.      In order to achieve an approximation to a clinical setting we want to compared the same     effectiveness of biofilm removal similarly on steel pins directly after explantation from     patients treated with external fixators for at least 2 weeks. Sonication and SEM will be used     for analysis.      Preliminary Results Laser fluences exceeding 2.8J/cm2 caused a complete extinction of all     living cells by a single laser impulse. Temperature rise within the implant is dependent on     repetition frequency but overall negligible.      The effectiveness of biofilm removal after cleansing with Octenidine soaked gauze and     irradiation with the Er:YAG laser will be evaluated on cultivated and extracted pins.      Conclusions We want to compare the effectiveness of the Er:YAG laser and Octenidine in the     removal of biofilms from half-pins. We hypothesize that thee Er:YAG laser offers a secure,     complete and non toxic removal of all kinds of pathogens from steel implants without damaging     the implant or possible development of resistances. The precise non-contact removal of     adjacent tissue could be an advantage over other disinfectants.      Level of Evidence (II-a)      Clinical Relevance:      Having one more arrow in the quiver for disinfection of percutaneous implants or for septic     revision surgery when osteosynthesis equipment or arthroplasties are meant to be left in     place would be extremely desirable.   "
4559|NCT03226171|"     This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients     with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is     assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also     assessed during this period. Patients who completed the first treatment period proceed to the     second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and     safety of SK-1403 are also assessed during this period.   "
4560|NCT03226158|"     The majority of children and adolescents diagnosed with cancer will experience one or more     episodes of fever or infection during their course of therapy. The most common     microbiologically documented infection is bloodstream infection (BSI), which can be     associated with severe sepsis or death. Current methods of diagnosis require a significant     load of live bacteria in the blood making early detection difficult. Delayed diagnosis and     delayed optimal therapy of BSIs are associated with increased morbidity and mortality.      This study seeks to identify whether next generation sequencing (NGS) of pathogens can     identify patients with impending bloodstream infection. This would enable preemptive targeted     therapy to replace antibacterial prophylaxis which often leads ot high-density broad-spectrum     antibiotic exposure and contributes to subsequent development of antibiotic resistance.      PRIMARY OBJECTIVE:        -  To estimate the sensitivity and specificity of next generation pathogen sequencing for          prediction of bloodstream infection in children with cancer at high risk of infection.   "
4561|NCT03226145|"     Constipation is a common condition in which an individual suffers with hard stools which are     infrequent and difficult to pass. It is poorly understood and treatment is often     unsatisfactory. Many patients also experience pain whilst others do not but it is unclear why     . It is believed that the pain arises from contractions in the colon, the lower part of the     intestines. Some patients with constipation have weak colonic contraction but surprisingly     some, particularly those with a lot of pain have strong contractions which are poorly     coordinated. These patients all suffer from constipation but would are likely to need very     different treatments. At present we cannot identify what type of abnormality of colonic     contractions each individual patient suffers from and so are unable to give them the best     treatment. This study will take advantage of two new techniques which have been recently     developed. Magnetic Resonance Imaging (MRI) which will allow us to see the contractions of     the colon in response to a dose of the laxative Moviprep which increases the flow of fluid     into the proximal part of the colon and High Resolution Manometry (HRM) which measures the     power and direction of the contraction in much more detail than ever before using a pressure     sensing catheter placed into the bowel. Using these 2 techniques we will identify the pattern     of contractions in 80 patients with constipation and 40 healthy controls. Participants will     then enter into a controlled trial of either a drug which stimulates contractions or one     which inhibits contraction. We anticipate that the pattern of contractions identified by the     non-invasive MRI technique will predict which treatment will reduce their symptoms most as     effectively as the more invasive HRM. If this is the case then our MRI test of colonic     responsiveness could become widely used in routine clinical practice   "
4562|NCT03226132|"     Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among     trauma exposed individuals. The current proposal aims to address the critical need for     targeted direct SUD prevention in this population by intervening on a novel, malleable risk     factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance     prospectively predicts the development of SUD and may confer risk for SUD by increasing     stress reactivity, decreasing decision-making abilities, and ultimately promoting substance     use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge,     no experimental studies have determined whether improving sleep leads to reductions in SUD     risk. As such, the current study will use a randomized controlled trial design to test the     effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a     sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to     determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD     symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms     through improvements in sleep. Furthermore, we will test direct and indirect effects of     condition on theoretically proposed mechanisms underlying the association between sleep     disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).   "
4563|NCT03226119|"     This post-market study is intended to assess the performance of the HTLV Blot 2.4 in     repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known     positive infection (n=50).   "
4564|NCT03226106|"     Although total knee arthroplasty is an effective intervention for decreasing knee pain and     improving physical function, physical activity levels remain low up to a year after surgery.     This study will use mobile-health technology to deliver an intervention designed to improve     physical activity behavior for Veterans recovering from total knee arthroplasty. The study     will assess the effectiveness of using behavior-change intervention as a supplement to     conventional rehabilitation to improve physical activity. The intervention will be delivered     using home-based tablet computers for Veterans to have remote interaction with the researcher     and real-time physical activity feedback from a wrist-worn activity sensor.   "
5827|NCT03209635|"     A The aim of this study was to investigate the impact of consuming Weissella cibaria (W.     cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on     natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin     (Ig).   "
4568|NCT03226054|"     Gastroesophageal Reflux Disease (GERD) can happen when stomach acid flows backward into     your esophagus (tube from the mouth to the stomach), causing symptoms such as heartburn.     Proton pump inhibitors (called PPIs) are a type of medication that reduce acid in the     stomach and are used to reduce the discomfort from GERD. Treatment for GERD with PPIs is     recommended to last up to eight weeks; however, many people take them for longer periods.     Some people are placed on PPIs (particularly in the hospital) to prevent ulcers and     inflammation of the stomach, but they do not need to be on the medication long term. Previous     research studies have shown that there are some risks with taking PPIs for a long time. These     risks include the inability of your body to absorb some vitamins and minerals, certain     infections such as pneumonia or the digestive tract infection called C. diff, and possibly     bone fractures. Therefore, it is desirable to stop taking a PPI when possible.      The purpose of this study is to use a standard approach to help patients stop taking PPIs by     adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their     PPI dose. All medications used for this study are approved by the U.S. Food and Drug     Administration (FDA). You are being asked to take part in this study because you have been     taking a PPI for longer than the recommended time, and have either a diagnosis of GERD,     gastritis, or an unclear indication for being on a PPI. About 100 patients from the Mount     Carmel St. Ann's Family Medicine practice will participate in this research.   "
4569|NCT03226041|"     To investigate the accuracy and correlation of estimating arterial CO2 pressure（PaCO2） using     a transcutaneous CO2 pressure（PTCCO2） monitor in patients undergoing retroperitoneoscopic     renal or adrenal surgery.   "
4570|NCT03226028|"     The capacity of music to relieve pain has been used in many forms of medicines and has been     proven to reduce anxiety, pain and need for analgesia in perioperative setting. However,     music listening as an inexpensive and duplicable method has not been studied in the local     context. The investigators hereby propose a prospective study to recruit women who undergo     surgery to evaluate the effectiveness of music in pain relief and post-operative recovery in     KKH; as well as the possibility of implementing music listening in perioperative setting.      The patients will be offered to listen to one out of several pre-determined lists of music of     different genres before, and after surgery. Data including pain score, Hospital Anxiety and     Depression Scale (HADS) score, EuroQol-Five Dimensions questionnaire-using Three Levels     (EQ-5D-3L), vital signs, analgesia usage and patient satisfaction will be collected in the     perioperative period. The collected data shall also be assessed if they are affected by the     presence of music, duration of music listening, and the genre chosen by the patients.      The investigators believe that this study could help determine the clinical relevance of     music for pain relief in local setting, which potentially could reduce patient pain and     anxiety caused by surgery. This in turn could allow music listening to be adopted as a     non-invasive pain relief intervention in local healthcare settings and further improve     patient outcome with lower cost and greater convenience as well as safety.   "
4571|NCT03226015|"     PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in     eyes with limbal stem cell deficiency.      DESIGN: Prospective observational study.      METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa     graft transplantation with amniotic membrane transplantation with a mean follow-up of 19     months. Clinical course of the disease including emergency surgeries, planned curative     procedures, conjunctival inflammation, acute inpatient treatment and best corrected visual     acuity were assessed at 3 months postoperatively and at last follow up visit. The unneeded     parts of oral mucosa graft were analyzed immunohistochemically with staining for mesenchymal     stem cell markers and pericytes (CD 90, CD 146, CD 166, CD 31, CD 68, protein gene product).   "
4572|NCT03226002|"     After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60     years of age undergoing maxillofascial, oral and double chin surgery to determine which     nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay     aimed to compare the glottis visualization time, intubation time and total intubation times.   "
4573|NCT03225989|"     This Phase I/II trial evaluates LOAd703 in patients with cancer (pancreatic, biliary,     colorectal or ovarian) together with their standard of care chemotherapy or using gemcitabine     immune-conditioning. LOAd703 is administered by intratumoral image-guided injections. Maximum     50 patients can be enrolled.      LOAd703 is an immunostimulatory gene therapy using an selection replication competent     adenovirus as a gene vehicle. The virus is derived from serotype 5 adenovirus with the fiber     from serotype 35. It expresses the transgenes trimerized membrane-bound isoleucine zipper     (TMZ) TMZ-CD40L and 41BBL under control of a cytomegalovirus (CMV) promoter.   "
4574|NCT03225976|"     Phototherapy is a therapeutic resource of increasing use in the last decade. The     photobiomodulatory effects are commonly produced by means of low intensity lasers or LED     emitting diodes, and can be used at different wavelengths. These light sources are divergent     as to coherence, but produce equivalent tissue effects. The application of laser or LED light     is able to induce biochemical changes in tissues, allowing for inhibitory or stimulating     effects. These responses are associated to a cascade of cellular reactions, which favor the     absorption of enzymes by cytochrome c oxidase, generating physiological responses that lead     to decreased production of reactive oxygen species and increased synthesis of adenosine     triphosphate (ATP). The application of this therapeutic resource brings ergogenic and     protective benefits in muscular performance. The use of LED as a light source is promising     because of its low cost, but there are no enough studies that support this use in athletes,     with a focus on performance improvement. In addition to the deficiency of the sample, there     is also no consensus regarding the use of different wavelengths for LED in the literature,     thus opening gaps for the best protocol for the application of this technique. Therefore, a     study that evaluates the use of LED in athletes, with different wavelengths, to improve     performance is necessary. Hypothesis: It is hypothesized that the LED application is capable     of improving athletes performance in terms of increased fatigue resistance, increased     strength and power, increased muscle recruitment, and optimized oxygen demand. It is also     expected that the results generated in this study can contribute to and increase the     resources used by physiotherapists within the clinical-sports field, contributing to the     post-training recovery, as well as the more effective physical performance in competitive     activities.   "
4575|NCT03225963|"     Bevacizumab has become the standard of care of recurrent glioblastoma based on promising     clinical trial results with with response rates up to 50% and progression-free survival up to     9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab     response.   "
4576|NCT03225950|"     This study evaluates the interaction between host immune cells and bacteria associated with     periodontitis. It comprises biological material from donors with and without periodontal     disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations     and measurements of selected parameters related to periodontitis to clarify obscure areas in     the immunologic pathogenesis of this disease.   "
4583|NCT03225859|"     Veterans who complete trauma-focused therapies (TFTs) report improvements in posttraumatic     stress disorder symptoms, quality of life, and social and role functioning. However, many     also report uncertainty regarding their ability to maintain and build upon progress made     during TFTs following the end of treatment. Veterans who recently completed a course of TFT     believe the likelihood of their ongoing success would be bolstered by mental health services     that support additional practice and reinforcement of skills learned in TFT. Currently no     evidence-based approach for post-TFT care exists; however, Veterans' reported treatment needs     are well-suited to a therapist-assisted self-management approach. The objective of this     project is to complete Stage 1 (intervention refinement and piloting) of the Stage Model of     Treatment Development for a post-TFT therapist-assisted self-management program designed to     help Veterans maintain or build upon gains made in TFT, increase self-efficacy for managing     their PTSD symptoms, and enhance community engagement. The aims of the project are to: 1)     Refine a self-management treatment protocol through eliciting feedback from experienced TFT     providers on a draft of the self-management program, 2) Conduct a pilot open trial to assess     the acceptability and feasibility of the self-management program, and 3) Explore the effects     of the program on Veterans' confidence in managing their PTSD and Veterans' functioning,     quality of life, community engagement, and mental health symptoms.   "
4584|NCT03225846|"     PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled     study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)     of single and multiple doses of WVE-120102 in adult patients with early manifest Huntington's     disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362331 (SNP2).   "
4585|NCT03225833|"     PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled     study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)     of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's     disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).   "
4586|NCT03225820|"     (a) To explore the feasibility and utility of implementing broad preemptive pharmacogenomic     result delivery in the inpatient setting across multiple institutions specifically with the     goal of incorporating minority-specific pharmacogenomic information; (b) To determine whether     clinical outcomes for the drug warfarin are improved in African Americans through the     availability of pharmacogenomics-based dosing guidance at the point-of-care.   "
4587|NCT03225807|"     This is a quality improvement study with the purpose of observing and measuring the effects     of implementation of a proven standardized lung protective ventilation protocol in the new     electronic medical record system iCentra across all Intermountain Healthcare hospitals.     Approximately 14,000 records will be accessed for this study from a database of mechanically     ventilated patients established for quality improvement purposes.      The investigators hypothesize that implementation of a standardized computerized lung     protective ventilation protocol across all Intermountain Healthcare hospitals will be     feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve     outcomes.      The objectives of this study are to:        -  Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal          volume ventilation protocol on initiation of mechanical ventilation) improves outcomes          in patients with acute respiratory failure requiring mechanical ventilation        -  Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal          volume ventilation protocol on initiation of mechanical ventilation) improves outcomes          in the sub-group of patients with the acute respiratory distress syndrome (ARDS)        -  Measure compliance with the implementation of a computerized lung protective ventilation          protocol at 12 Intermountain Healthcare hospitals   "
4588|NCT03225794|"     About three quarters of the viral agents that have emerged recently in humans are considered     to originate from other animals. These viruses have often evolved and spread into the human     population through various mechanisms after the initial contact that resulted in interspecies     transmission. However, knowledge of the initial stages of the emergence of viruses and     associated diseases is still limited in many cases. Microbiological monitoring in populations     at risk of transmission would provide insights into the initiation and early stages of the     emergence process.      Nonhuman primates (NHPs) share many genetic, physiological, and microbiological features with     humans, and are potential sources of many infectious agents. This has been demonstrated for     several simian retroviruses. HIV-1 and 2 are believed to have originated from chimpanzee and     mangabey viruses, respectively, found in Central and West Africa. The current distribution of     the various molecular subtypes of the HTLV-1 oncogenic retrovirus in Africa is mainly the     result of numerous instances of interspecies transmission of STLV-1from NHP species in the     distant past.      Foamy viruses belong to the Retrovidae family and the Spumavirus genus. They are complex     exogenous retroviruses and are very common in many animal species, including primates, cats,     cattle, and horses, in which they cause persistent infections.      The first aim of the work is to study the epidemiological and molecular aspects of the     transmission of foamy viruses from monkeys to humans in populations at risk, such as the     inhabitants (especially hunters) in the villages of the dense forests of southern Cameroon.     It is an area in which NHPs are still very common, with a great diversity of species. The     investigators have already shown that the prevalence of foamy viruses is very high in these     monkeys and great apes (gorillas and chimpanzees). Contact between these monkeys and the     villagers is very frequent, mainly during hunting. The second aim of the project is to study     the clinical and biological features of infected people and investigate intrafamilial     transmission from infected index cases.   "
4589|NCT03225781|"     Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the     cells through the local creation of pores in the cell membrane. The electric pulses can be     applied directly to the neoplastic cells, allowing for the local concentration of a possible     chemotherapeutic agent administered through the bloodstream. This technique does not use heat     nor other thermal energies and it is performed using special needles/electrodes linked to a     generator (porator).      In this study this technique will be applied on unresectable pancreatic cancer, already     submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will     be the chemotherapeutic agent.   "
4601|NCT03225625|"     The SciExVR study will evaluate the potential benefit of autologous bone marrow derived stem     cells (BMSC) in the treatment of spinal cord injury with evidence of impaired motor or     sensory function. The treatment consists of bilateral paraspinal injections of the BMSC at     the level of the injury as well as superior and inferior to that spinal segment followed by     an intravenous injection and intranasal placement. Patients undergoing BMSC treatment may     also be assigned to use of exoskeletal movement (or equivalent) or virtual reality     visualization (or equivalent) to augment upper motor neuron firing and/or receptivity of the     sensory neurons.   "
6124|NCT03205722|"     A retrospective, observational study based on chart reviews for patients with advanced     melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June     2015 and June 2016, conducted in a representative sample of sites in Germany.   "
4590|NCT03225768|"     Abstract      Participation is an ultimate rehabilitation goal that is important to patients, providers,     and insurance payers. Since the International Classification of Functioning, Disability, and     Health (ICF) published, a growing body of literature has emerged to investigate participation     among people with functional limitations in diverse service settings. However, no research to     date has developed an effective intervention that show promise to successfully enhance     participation among individuals with cognitive impairments after stroke and traumatic brain     injury (TBI).      The purpose of this study is to examine the feasibility of applying an intervention strategy     that has shown promise to increase functional independence of rehabilitation patients with     cognitive impairments, the guided training, to enhance participation performance among     individuals with cognitive impairments after stroke and TBI in the outpatient rehabilitation     settings in Taiwan.      A mixed-methods (quantitative and qualitative) design, including a repeated measures design,     will be used in this feasibility study. Adults (n=45-60) who had a first-time stroke or TBI     within the past six months and have cognitive impairments will be recruited from the great     Taipei area. These participants will receive 2 to 3 intervention sessions per week for 10 to     15 sessions. Standardized assessments, including the Participation Measure--3 Domains, 4     Dimensions (PM-3D4D), the Activity Measure for Post-Acute Care (AM-PAC), and the Wisconsin     Card Sorting Task (WCST), will be used to assess participation and other functional outcomes     at baseline, post-intervention, and 3-month and 6-month follow-up. The feasibility     indicators, such as recruitment rates and intervention attendance and adherence, will be     evaluated by questionnaires, field notes, and qualitative interviews after the interventions     are completed.      Quantitative data will be analyzed descriptively; while data obtained from the outcome     measures will be examined using Wilcoxon signed rank test and effect size (r) to compare the     differences between the pre- and post-intervention scores. Qualitative data will be analyzed     using thematic analysis method.   "
4591|NCT03225755|"     The growth hormone (GH )axis has important influences on adipose tissue. GH may have a novel     effect to reduce macrophage yet increase adipocyte inflammation in adipose tissue along with     reducing adipose tissue mass. In order to examine the effect of GH on adipose tissue     inflammation, this study will examine adipose tissue and serum inflammation in patients with     GH deficiency before and after GH therapy. The investigators will also obtain serum samples     before and after treatment for adipokines, inflammatory markers and examine macrophages in     circulation with regard to their inflammatory state. The investigators will also obtain     adipose tissue biopsies from healthy subjects matched to the GHD subjects. Adipose tissue     specimens will be analyzed for adipose tissue morphology, adipocyte size, adipokine gene     expression, and adipose tissue macrophage number.   "
4592|NCT03225742|"     After incontinence surgery, the patients randomly will be divided two groups. In group A     postoperative urinary catheterization time will be applied one day, In group B     catheterization will be applied two days. After removal of urinary catheter, residual volume     will be measured and voiding function will be controlled. In postoperative period; third,     sixth month and one year after surgery stress test will be applied to control success of     surgery   "
4593|NCT03225729|"     This study evaluates the performance of new technology CRYOTHERAPY MAINS ET DECOLLETE     against a classic cryotherapy Nitrogen Liquid  to treat solar lentigines.      The hands and the neckline will be randomised, either left or right side and treated by two     cryotherapy devices:        1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.        2. Liquid nitrogen is a comparator device.   "
4594|NCT03225716|"     This research study is studying Ulocuplumab combined with ibrutinib as a possible treatment     for symptomatic Waldenstrom's Macroglobulinemia (WM).   "
4595|NCT03225703|"     Osteoarthritis (OA) and osteoporosis (OP) affect large numbers of the population. Around 8     million people in the UK are affected by OA and over 300,000 people present with fragility     fractures in the UK each year. High impact exercise has been shown to improve markers of bone     health but the effect of this exercise on the cartilage is less well understood. A six month,     one leg, exercise program based on hopping will be carried out by a group of post-menopausal     women. Post-menopausal women are particularly at risk from OP and the research should give     information on the feasibility of this type of exercise program in this age group and the     effect on cartilage. Participants will be aged between 55 and 70 (at least five years post     menopause) with no conditions that would limit their ability to complete the exercise     program.      To assess changes in participants' cartilage and bone properties they will be asked to attend     several meetings at Loughborough University. Before and after the exercise program     participants will have bone density scans and MRI scans of the knee joint. A subset (n=4)     will undergo high resolution bone scans that can demonstrate changes in bone structure. The     intervention is a home based exercise programme lasting approximately 10 minutes per day.     Initially this will be individualised to each participant with the end goal being daily     exercise sessions. The programme will last for six months with supervised sessions offered     throughout the trial. Using an intervention affecting just one leg will allow the research     team to use the other leg as a control.      The research team hypothesise that in a population of post-menopausal women, a six month,     unilateral exercise intervention will improve bone mineral density at the proximal femur with     no negative effects on articular cartilage.   "
4596|NCT03225690|"     American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing     major abdominal surgery in obstetric and gynaecology clinic were recruited to this study.     Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the     all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6     mg/kg rocuronium. Desflurane and azot protoxit (N2O)-O2 will use for anaesthesia maintenance.     During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the     end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural     catheter before surgical incision. In group II, 1 mg morphine will apply from epidural     catheter before surgical incision. In group III, 1 mg morphine will apply from epidural     catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia     will provide with bupivacaine for postoperative analgesia. Postoperative pain will be     assessed with numerical pain scale. Postoperative analgesic requirement will be calculated.     Hyperalgesia will detect with algometer and von Frey ligaments.   "
4597|NCT03225677|"     To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in     cirrhotic patients by using multiple tracers and single muscle biopsies.   "
4598|NCT03225664|"     There are 2 parts in this study.      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     trametinib when given with pembrolizumab to patients with refractory (has come back after     treatment) non-small cell lung cancer (NSCLC).      The goal of Part 2 of this clinical research study is to learn if pembrolizumab given alone     or in combination with trametinib at the dose that was found in Part 1 of the study can help     to control NSCLC in patients who previously received chemotherapy or immunotherapy.      The safety of the study drugs will be studied in both parts.   "
4602|NCT03225612|"     The purpose of this study is to assess the safety and performance of the Trialign System for     the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients     with a minimum of moderate tricuspid regurgitation.      The procedure will be performed with the PTVAS device using a non-surgical percutaneous     approach to tricuspid valve repair in patients who have FTR with a minimum of moderate     tricuspid regurgitation.   "
4603|NCT03225599|"     Patients who have concussions exhibit an array of symptoms, also known as post-concussive     symptoms, including headaches, feeling slowed down or foggy and difficulty with     concentration. This study aims to determine if cranial osteopathy can provide additional or     expedited symptom relief when accompanying current conventional treatments. The patients will     be identified through routine clinical contact. If patients are found to be eligible and     agree to participate, they receive a single session of cranial osteopathy in addition to     their usual care through the concussion program.   "
4604|NCT03225586|"     To examine the impact of health determinants at the individual (e.g. health related     behaviors) and societal level (e.g. environmental factors, health related policy, quality of     health systems) on health outcomes (e.g. death, non-communicable disease development) across     a range of socioeconomic and health resource settings. Additional components of this study     will examine genetic factors for non-communicable diseases. This will be examined both     through a cross sectional component, and prospectively (cohort component).   "
4605|NCT03225573|"     a cross-sectional study to estimate the prevalence of a second mesiobuccal canal of maxillary     first and second molars in Egyptian population using cone beam computed tomography through     retrospective data analysis   "
4606|NCT03225560|"     This is a randomized controlled trial designed to assess the efficacy of a novel smartphone     application as an automated reminder tool in improving the quality of bowel preparation for     patients undergoing outpatient colonoscopies. The investigators will be comparing the     smartphone application to traditional instructions for bowel preparation. The quality of     bowel preparation will be assessed using the Ottawa and Aronchick bowel preparation scales.   "
4607|NCT03225547|"     This is a Phase II study of pembrolizumab plus mifepristone in advanced breast cancer     patients. The study will include a safety lead in of ten patients. Patients who are deemed     eligible and have signed informed consent will be treated with pembrolizumab at a fixed dose     of 200 mg intravenously on day 1 of each 21 day cycle for each dose level. Mifepristone 300mg     PO be administered daily starting the week prior to pembrolizumab.      Once the safety of the combination is confirmed (study will be paused at least 6 weeks after     first 10 patients are enrolled for safety evaluation), dose expansion cohorts will be     performed in parallel for two cohorts: cohort 1 in triple-negative breast cancer and cohort 2     in hormone receptor positive breast cancer.   "
4608|NCT03225534|"     This proposal relates to the testing of several specific hypotheses in a subset of 500     participants in the Canadian Healthy Infant Longitudinal Development (CHILD) Study. These 500     now have complete data from the time of recruitment (in pregnancy) to age 1 year. The primary     purpose of this proposal is to identify risk factors for early allergic outcomes and     biomarkers that may predict future disease. These 500 infants will provide critical     preliminary data, not only related to early outcomes, but also to inform analytical plans for     the full CHILD cohort.   "
4609|NCT03225521|"     The aim of this research is to evaluate the efficacy of contextually tailored activity     suggestions and activity planning for increasing physical activity among sedentary adults.   "
4610|NCT03225508|"     This study evaluates the movement of the diaphragm (which is the main muscle used for     breathing). It will compare two ultrasound modalities: linear ultrasound versus curvilinear     ultrasound, at measuring diaphragm motion. The proposed measurement method with linear     ultrasound is novel, and will be compared against the established method with curvilinear     ultrasound. The investigators hypothesize that the novel method will have several potential     advantages, including: it may be easier to learn, quicker to perform, and have a lower     failure rate.   "
4611|NCT03225495|"     The main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without     bone regeneration versus standard diameter implants (4.3 mm) in combination with bone     regeneration. To do so, patients with missing upper central incisors, canines, first or     second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental     implants. Cone beam computed tomographic examination and clinical values will be registered     before and after the surgical procedure at 6 and 12 months.   "
4612|NCT03225482|"     The number of older Veterans with Mild Cognitive Impairment (MCI) seeking care within the     Veterans Affairs (VA) health care system is increasing and is expected to increase more     rapidly as Vietnam era Veterans age. The cognitive effects of MCI and subsequent     neurodegenerative disorders can adversely affect a Veteran's ability to function     independently and failure to provide appropriate intervention can result in an increased need     for healthcare services and VA benefits in the future. The VA currently spends over $19,000     annually per patient to care for Veterans with dementia (Zhu et al., 2009), and delaying the     onset of dementia even by one to two years will result in substantial financial savings to     the VA and quality of life gains for the Veteran. Since present pharmacological interventions     have demonstrated limited efficacy, alternative treatments are needed. Therefore, an     evidence-based cognitive training intervention that optimally addresses the needs of older     Veterans with MCI is of critical importance to the VA patient care mission.   "
4613|NCT03225469|"     Enhanced instructions such as re-education by telephone or short message which increase the     patient adherence eventually improve the quality of bowel preparation significantly. However,     the effect of family assistance which plays an essential role on compliance of patient with     treatment on bowel preparation is unknown. The investigators hypothesized that reinforced     education giving family members of outpatients will enhance family support to patients for     colonoscopy, and consequently improve the quality of bowel preparation.      Therefore, the investigators designed protocols to reinforce family member education by     verbal (face to face or telephone) and written methods. The aim of this study is to evaluate     the effect of reinforced family member education on patient compliance and the quality of     bowel preparation for colonoscopy. In addition，the rate of side effects happening, the     subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent     risk factors will be also assessed.   "
4615|NCT03225443|"     Locally advanced cervical cancer (LACC) refers to the clinically cervical visible lesion with     a diameter of > 4 cm, which has been considered as a high risk of early cervical cancer for a     long time. Because of local bulk lesion of LACC, the risk of radical hysterectomy is pretty     high and the radical effect commonly does not meet the satisfactory. Therefore, 1-3 course of     neoadjuvant chemotherapy (NACT) were carried out before operation. However, nearly 20% of     patients are not sensitive to NACT. Therefore NACT did not bring any benefits to radical     surgery even to some extent delayed the treatment.      Traditional radiotherapy is also commonly used in the treatment of LACC, however ovarian     function would be permanently destroyed especially for young patients, additionally     radioactive complications to adjacent organs of cervical such as vagina, bladder and rectal     also commonly happened, moreover sexual dysfunction after radiotherapy significantly affect     the life quality of young patients.      Particle radiotherapy developed recently, has the advantages of short course of treatment and     mild side effects, due to its special working mechanism, Bragg effect. So the amount of     radiation in the tumor tissue is very extremely high, and in the adjacent tissue is quiet     low, therefore the organs at risk were protected by avoiding unnecessary damage.      Based on these, we proposed the application of particle radiotherapy in LACC pre-operation,     and comprehensively evaluated recent curative effect, complications and long-term follow-up     between particle radiotherapy and NACT. Furthermore, the clinical significance and long-term     application prospects about particle therapy were objectively assessed.   "
4616|NCT03225430|"     It is a randomized controlled trial to compare two behavioural treatments, namely CBIT and     CoPs. This study would be the first head-to-head randomized trial between two established     treatments rather than supportive counseling or wait-list control. Thirty-six adults and 36     children with TS/TD will be recruited into each of the two (CBIT, CoPs) modalities requiring     a total recruitment of 72 adults and 72 children over 5 years, which permits, even for a     small-medium effect size, a robust power calculation. Motor performance measures will give     concurrent validity to changes pre-post in TS/TD motor processes. Recruitment of both males     and females will permit sex comparisons. The participants meeting inclusion/exclusion     criteria will be assessed at pre-post 1 month and 6 months following treatment on     standardized tic scales and global assessment of functioning. Participants will be treated     individually on a weekly basis by therapists with an allegiance to each modality and outcome     assessed by masked evaluation. The treatments are manualized and will last 10 weeks with 4     weeks of home practice at post-treatment with 6-month follow-up assessment on all outcome     measures, plus motor performance measures post-treatment. All treatment sessions will be     audio-recorded and assessed with implementation of treatment integrity procedures scales. The     hypotheses are that: (1) the CoPs group will show superiority in clinically significant     improvement on standard tic scale score, global functioning and quality of life than the CBIT     group; and (2) changes in recognized parameters on selected motor tests scored according to     published norms will change towards normalization post CoPs but not post CBIT. The outcome     data from the two treatments will be analyzed by a mixed linear model adaptation of repeated     measures MANOVA and daily diary measures will allow for an additive time series design over     the 10 weeks treatment session. This design will allow computation of the size of treatment     effects at different stages of therapy. The study results will impact on the treatment of     choice and access to treatment for tic disorders and on the conceptualization of tic     disorders.   "
4617|NCT03225417|"     Allogeneic hematopoietic stem cell transplantation (HTC) is the only curative option for many     patients with hematologic malignancies but >50% of this patients will develop extensive     chronic graft-versus-host disease (cGVHD), which remains the most important complication     after HTC.      Classically, the most effective strategies to prevent GVHD have not improved survival;     therefore, the new strategies are being sought.      This study is designed in two phases: the main objective for phase I study is the more     suitable dose for ixazomib search. Phase II study is designed to evaluate the efficacy of     ixazomib at the doses stablished in phase I.   "
4618|NCT03225404|"     The concept of epicondylitis refers to the manifestation of pain ni the area of insertation     of the epicondile muscles, and that it is accompained by limitation funcional.A tendinopathy     is characterized as a process of degenaration, with fibroblast proliferation and     disorganization of the fibers of collagen. This tendon pathology especially affects the     epicondyle extensors and especially the first and second radial and short extensor carpal.   "
4619|NCT03225391|"     Sleep deprivation produces changes including alteration of mood, irritability, fatigue, less     focus and disorientation, also perceptive distortions, visual hallucinations and considering     tasks harder and less pleasant. In resident phsycians, these alterations have been shown to     affect their work performance. Naps have proved to improve arousal and attention, alertness     and performance. Those longer than 90 minutes promote a learning process similar to that     ocurring in REM sleep. Therefore a nap schedule could improve the decision making of     residents during their working hours.   "
4620|NCT03225378|"     The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of     blood that can be repeated as frequently as required without infusing a drop of fluid. Two     recent meta-analyses of many studies have confirmed the reliability of the PLR test to     predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the     effects of the PLR must be assessed by the direct measurement of cardiac output since changes     in arterial pressure do not allow the assessment of the PLR hemodynamic effects with     reliability. Moreover, cardiac output must be measured continuously and in real time.      In clinical practice, cardiac output measurement can be difficult for different reasons such     as the unavailability of the echocardiography machine, or the absence of any continuous     cardiac output monitoring technique at the time of acute circulatory failure occurrence.      Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the     mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid     responsiveness with reliability in patients ventilated with low tidal volume (<8 mL/kg of     ideal body weight).      Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be     able to predict fluid responsiveness with reliability in mechanically ventilated patients     with acute circulatory failure.   "
4621|NCT03225365|"     This is an open bi-centric prospective non-randomized study in patients with metastatic     melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the     study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and     identify the differences between responder and non-responder patients.   "
4622|NCT03225352|"     The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets   "
4684|NCT03224546|"     Reduced drug use is a clinically meaningful target for treatment development, but few studies     have evaluated the positive impacts produced by this behavioral change, preventing adoption     of this endpoint in clinical trials. The proposed research will fill that critical knowledge     gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be     used to change current accepted cocaine treatment endpoints and accelerate identification of     therapies for cocaine use disorder.   "
4623|NCT03225339|"     Diabetes is one of the greatest challenges faced by healthcare services worldwide. It is     associated with serious complications such as heart attacks, stroke, and peripheral artery     disease as well as kidney disease, eye disease, and nerve dysfunction. Data from weight loss     with bariatric surgery suggest that with the appropriate intervention, it should be possible     to reverse diabetes and that the earlier the intervention occurs, the greater the chances of     placing diabetes into remission. There is now a need to translate this knowledge into the     medical care of younger patients with early diabetes who are overweight/obese. The aim of     this study is to see if younger adult patients with overweight/obesity and type 2 diabetes     who are participants in a programme incorporating a low energy diet and physical activity     (lifestyle) will lower their weight, cardiovascular risk and improve their glycaemic control     as compared to the usual care.   "
4624|NCT03225326|"     The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular     parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and     middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled     delivery for maxillary teeth extraction.   "
4625|NCT03225313|"     Prospective randomized double blinded controlled clinical trial will be done with a total     number of 75 patients will be divided into 3 groups. To compare between Ultra-sound guided     rectus sheath block VS Field block infiltration in providing a good analgesia for patients     undergoing midline hernia repair to detect which one is superior.   "
4626|NCT03225300|"     Simultaneous integrated boost (SIB), a field-in-field escalation technique, has been     introduced to deliver higher radiation dose to the certain part of target with the same     fractionation scheme. The aim of this study was to investigate the value of chemoradiation     (CCRT) using SIB in glioblastoma and the correlation with surgical extent.   "
4627|NCT03225287|"     The purpose of this study is to enable continued access to RA101495 for patients with     paroxysmal nocturnal hemoglobinuria (PNH) after they complete a RA101495 clinical study.   "
4628|NCT03225274|"     The study evaluates the effectiveness of Breathing Exercises as Therapeutic Play on     respiratory Status among children with Lower respiratory Tract Disorders. patient were     allocated into two groups- Experimental group and Comparison group. Experimental Group     received Breathing Exercises as Therapeutic Play after administration of Nebulization therapy     and comparison Group received no Breathing Exercises.   "
4630|NCT03225248|"     This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority,     phase III clinical trial evaluating efficacy and safety of once-daily mosapride     (UI05MSP015CT) in patients with functional dyspepsia.   "
4631|NCT03225235|"     The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT)     using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.   "
4632|NCT03225222|"     To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic     pathway of prostate cancer, with upfront individual multivariate risk stratification.   "
4633|NCT03225209|"     Type 2 diabetes (DM2) is a chronic disease affecting 29 million Americans and a leading cause     of blindness, kidney failure, and limb loss (Engelgau et al 2004). Roux-en-Y gastric bypass     (RYGB) is the only intervention that leads to durable DM2 remission ~ 80% of the time     (Mingrone et al 2012). Yet, it's broad application is limited by cost, invasiveness, and     clinical inertia. Medically reproducing RYGB would extend the benefit of disease remission to     the vast majority of DM2 patients using a cheaper, less invasive and more palatable treatment     approach. Although all of the mechanisms mediating DM2 remission are not known, it is widely     accepted that RYGB induces caloric restriction and enhances meal-stimulated release of a     gut-peptide called glucagon-like-peptide-1 (GLP-1) both of which improve glycemic control in     type 2 diabetes (Dar et al 2012; Jackness 2013). Caloric restriction can be achieved using     OPTIFAST which is a commercially available medical weight loss program that has demonstrated     the ability to decrease weight and improve glycemic control (Kirschner et al; 1998). Enhanced     meal-stimulated GLP-1 release can be achieved using Liraglutide an FDA-approved once daily     GLP-1 analogue that improves glycemic control and induces weight loss.      The investigators hypothesize that adding OPTIFAST (caloric restriction) in suboptimally     controlled DM2 patients on Liraglutide (enhanced meal stimulated GLP-1 release), Metformin     and Lantus insulin will medically reproduce RYGB and lead to DM2 remission, weight loss,     decreased medication intensity and improved health related quality of life.   "
4639|NCT03225131|"     Background:      Macular degeneration can cause permanent loss of central vision. This vision is important for     seeing details. Age-related macular degeneration (AMD) is the leading cause of vision loss in     people over 55 in the United States. Researchers want to follow people with AMD to study the     early to middle stages of the disease.      Objective:      To follow for another 5 years participants who completed NIH study 11-EI-0147.      Eligibility:      Participant was enrolled in and completed study 11-EI-0147.      Design:      Participants will have at least 6 study visits over 5 years. Each visit takes about 5 hours.      At visit 1, participants will be asked about their medical and eye disease history. They will     have an eye exam. The exam will test vision, eye pressure, and eye movements. The pupil will     be dilated with eye drops.      Participants will have baseline exams. These include a health history and questions about     problems that affect their eyes under different lighting. They will answer these questions     each year.      At each visit, participants will have some or all of these tests:      Eye exam      Dark adaptation protocol. This measures how fast the eyes recover when exposed to decreasing     levels of light. The pupil will be dilated with eye drops. Participants will sit in front of     a metal box with a camera inside. They will push a button when they see a light in the     machine.      View a bright background light for 5 minutes. After the light is turned off participants will     push a button when a blue or red light is seen.      Sit in the dark for about 30 minutes. Participants will push a button when they see a blue or     red light.   "
4685|NCT03224533|"     Multiple NHANES surveys were combined and weighted to evaluate relationships between walnut     consumption and type 2 diabetes mellitus using various independent measures of diabetes     status and risk. After risks were ascertained, interactions with gender were analyzed.   "
6145|NCT03205436|"     This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that     were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02     trial and receive Affinity fHSAM if certain criteria are met.   "
4640|NCT03225118|"     Background:      The immune system helps the body fight off disease. Most people infected with HIV cannot     control the infection and need daily medicine. Combination antiretroviral therapy (cART) are     drugs taken to prevent HIV infection from damaging the immune system. Researchers want to     study why some people develop resistance to the drugs or have permanent side effects.      Objective:      To study the impact of a short-term treatment stop on HIV that persists even while taking     cART.      Eligibility:      Adults 18-65 years old with HIV who are being treated with cART      Design:        -  Participants will first be screened with a physical exam and medical history. They may          have a chest x-ray. They will have heart, blood, and urine tests.        -  At the baseline visit, participants will repeat the screening tests except the x-ray.          They will get counseling about HIV and risk behavior.        -  Participants will have leukapheresis. Blood will be removed through a needle in one arm.          A machine will separate white blood cells from the rest of the blood. The remainder of          the blood will be returned to the body by a different needle.        -  Participants will stop their current treatment on day 0. They will visit the clinic each          week until they meet the criteria to restart cART. These visits will have the same          procedures as the baseline visit.        -  Before restarting cART, most participants will have leukapheresis.        -  After restart, participants will be seen weekly for 4 weeks and then monthly for about          11 months. Participants will have blood drawn, physical exam, and medical history. They          will have leukapheresis 2 more times over 1 year....   "
4641|NCT03225105|"     This dose-escalation study will evaluate the safety, tolerability, pharmacokinetic (PK),     pharmacodynamic, and signs of clinical efficacy of M3541 in combination with fractionated     palliative radiotherapy (RT) in subjects with solid tumors with malignant lesions in the     thorax, abdominal cavity, head and neck region, or extremities likely to benefit from     palliative RT.   "
4642|NCT03225092|"     This study will investigate the potential effects of platelet rich plasma for the treatment     of persistent medial knee pain after total knee arthroplasty. All study participants will     receive PRP injections and will be followed up to see if any benefit in regards to pain     and/or function is achieved.   "
4643|NCT03225079|"     International registry on the use of Pentaglobin® in patients with severe bacterial     infections; multicentric, international registry, non-interventional trial   "
4644|NCT03225066|"     This study aims to assess efficacy and safety of Sculptra in the treatment of skin flaccidity     in selected areas - arms, anteromedial region, and gluteal regions. To assess the efficacy of     Sculptra®, via adapted Global Aesthetic Improvement Scale -GAIS- score determined by blind     evaluator, in the treatment of skin flaccidity on the anteromedial region of arm and gluteal     region, 4 months after initiating the treatment, based on the assessment of the corporal side     randomized to be the first to receive treatment . Considering as an alternative hypothesis of     interest a 70% value of the subjects the treated side would have higher GAIS than the     untreated side.   "
4645|NCT03225053|"     A headache is a more common disorder and one that prevails over a lifetime of much of the     population. Among the causes are in the stress and spasms of the pericranial musculature,     presence of painful sensitivity in the region, decrease of pain threshold, and a presence of     trigger points (PGs) that can also cause as headaches. The solutions for health and health,     in addition to Percutaneous Microelectrolysis (MEP®), which is used in the application of low     intensity galvanic current through the acupuncture needle. Although it is a very common     pathology, it is still little studied and a lack of information is a question of solutions     such as crisis of care. This work justifies the negative bones of CTT in university students,     as this has repercussions on the quality of life, besides proposing a therapeutic approach to     reduce the symptomatology. The present study aims to investigate the effects of myofascial     release techniques, MEP® and an association of therapies, observing the impact on quality of     life and repercussions on academic performance. This is a controlled clinical trial of a     convenience-based approach, consisting of universities between the 1st and 10th Physical     Therapy course of Estácio Ponta Negra, over 18 years of age, who are not present in the     application of the questionnaires, It is necessary to use the medicine of the analgesic type.     The volunteers are evaluated through the HIT-6 and SF-36 questionnaires, after a selection of     pain evaluation, PGs and algometry. The randomization will consist of 4 groups, after a     consultation and an immediate re-evaluation and a second time and a new intervention and     re-evaluation. A descriptive and inferential statistics will be performed through the SPSS     20.0 program. The normality of the data is observed by the Kolmogorov-Smirnov (KS) test. For     a comparison between groups whose parametric data are applied or anova test with post hoc     tukey comingue of significance of 5% (p <0.05). It is believed that the use of the     association of myofascial release techniques and Percutaneous Microelectronics promotes     greater benefits in tension headache.   "
4646|NCT03225040|"     The investigators will conduct a cross-sectional study of bone density, bone     microarchitecture, vertebral fractures and trabecular bone score in 25 patients with     acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least     1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to     describe the bone architecture and associated biochemical indices of bone turnover and     metabolism in patients with active acromegaly and how these are altered with treatment of the     disease.   "
4647|NCT03225027|"     The purpose of the present study is to evaluate the effect of emotional prosody on the     perception of emotional discourse in the schizophrenic spectrum. The investigators     hypothesize that participant may use emotional prosody as an emotional cue to understand the     emotional content of discourse.   "
4648|NCT03225014|"     Accelerated Recovery Performance (ARP) Wave therapy is an electromyostimulation therapy     designed to enhance neuromuscular control in order to rehabilitate patients with     musculoskeletal pathology. The outcomes of this technology have not been assessed under the     rigors of clinical science. This prospective randomized crossover study will assess ARP Wave     to both shorten duration of therapy and determine other advantages in the treatment of     adolescent anterior knee pain. Two cohorts of teenagers will be followed weekly through     either physical therapy (PT) or ARP Wave therapy, physiological therapy versus neurological     therapy, respectively. Results should highlight the clinical utility of this modality and     provide pilot data for future study.   "
4649|NCT03225001|"     To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients     with a failing surgical aortic bioprosthetic valve.   "
4686|NCT03224520|"     The research study, Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate     Tobacco Interventions will test two smoker-driven, social marketing innovations to recruit     and engage smokers in Decide2Quit.org (Decide2Quit), which is an evidence-based, effective     Digital Intervention for Smoking Cessation.   "
6146|NCT03205423|"     The present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse     liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants     with both Opioid Use Disorder and Alcohol Use Disorder.   "
4650|NCT03224988|"     This project is focused on the gap in understanding of bilateral brain interactions and their     role in helping normative and clinical elderly populations maintain cognitive health. The     investigator will focus on investigating this neural mechanism of these interactions and     promoting them with a precise application of TMS, in order to test the hypothesis that     excitatory interactions between the hemispheres can provide positive outcomes for patients     with pre-clinical AD (amnestic Mild Cognitive Impairment or MCI-AD). In Session 1, the     investigator will establish the spatial specificity of bilateral brain mechanisms with     combination of behavior, TMS, and structural neuroimaging in cortical sites known to be     active during memory encoding. In Session 2, the investigator will establish the underlying     dynamics of interhemispheric communication using a novel combination of TMS and     electroencephalography (EEG) to establish the coordinated activity between the hemispheres;     Lastly, in Session 3, the investigator will use the TMS entraining parameters delineated in     Aim 2 to promote specific cross-hemispheric communication, applied to participants performing     a Picture Encoding task, a general task of memory performance. The outcome of these studies     will allow our group to evaluate the strength of this brain stimulation protocol in     alleviating age-related and dementia-related cognitive decline, and enable development of     novel treatment protocols for dementia in elderly cohorts.   "
4651|NCT03224975|"     Pain is complex phenomenon misunderstood in spite of medical progress and neurosciences.     That's why the relief of chronic pain is only partial for a lot of infection as arthrosis,     chronic back pain, headaches or neuropathic pain. Certain situations bring to relive pain     sensation. Investigators were interested to former burned. They wonder about somatic memory     and unconscious of acute.   "
4652|NCT03224962|"     This study will be conducted to compare the diagnostic predictive values of a light induced     fluorescence camera and Caries detection dye versus visual assessment method in     identification of occlusal carious lesion.   "
4653|NCT03224949|"     The availability of biological samples from individuals with alcoholic liver disease (ALD),     as well as samples from appropriate heavy drinking, yet healthy controls and non-drinking     healthy controls, is an essential first step in the translation of basic research advances to     the clinic. The purpose of the Clinical Core component of the P50 Northern Ohio Alcohol     Center (NOAC) is to provide biological samples (plasma/serum, buffy coats, and urine) from     patients with different stages of alcoholic liver disease, as well as healthy control     subjects, to members of the NOAC. These samples can then be used to test specific hypotheses     related to the presence of specific biomarkers in the serum, functional immune activity in     PBMCs and/or genetic polymorphisms that may predict severity of disease, short- and long-term     morbidity and mortality and/or responsivity to specific therapeutic interventions commonly     used in clinical practice. This study is building on the established biorepositories and the     diversity of outstanding clinical expertise at the Cleveland Clinic. This biorepository     included clinical samples (plasma, serum, buffy coats, and urine) from patients with     different stages of ALD and subjects who are heavy drinkers without ALD, recruited from the     Cleveland Clinic alcohol use disorder treatment clinic. This study will be responsible for     collecting more data to help build the CCF-ALD biorepository via subject recruitment and     communication and specimen collection.   "
4654|NCT03224936|"     While Drug Induced Sleep Endoscopy (DISE) in patients with obstructive sleep apnea syndrome     (OSAS) apnea and hypopnea occur. Because of the induced phases of apnea in a controlled     setting it is possible to evaluate the related pathophysiology of apnea. We plan to correlate     the Patient State Index (PSI) and other physiologic parameters with phases of apnea and     hypopnea.   "
4655|NCT03224923|"     In patients with heart attacks, the current standard of care is to restore blood flow through     percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens     up blockages. Following PCI, standard preventative drug treatment includes the use of dual     antiplatelet therapy (DAPT) using both aspirin and a platelet P2Y12 receptor inhibitor     (Ticagrelor 90 mg twice a day or Clopidogrel 75 mg once a day) for one year to prevent     clotting that can result in additional heart attacks, sudden clotting of stents or death.      New studies have shown that there is a benefit to continuing DAPT beyond this one year mark.     Longer-term DAPT has been shown to reduce ischemic events (heart attack, stroke) but increase     the risk of bleeding. Present guidelines state that the decision to continue DAPT beyond the     one year mark should be made on an individualized basis.      The present study is a pilot study that seeks to compare Long-Term use of Ticagrelor (LTT)     versus a Personalized Approach (PA). We will be recruiting patients who have been stable     (free of ischemic or bleeding outcomes) on DAPT for 1 year after initial presentation with a     heart attack.      The PA group will use a modified DAPT score based on patient demographics to decide whether     treatment is warranted. Patient will also undergo bedside genetic testing to identify     potential at-risk genes. Those identified as carriers will be treated with ticagrelor while     non-carriers will be treated with clopidogrel.      The present study will determine whether a personalized approach will decrease bleeding     versus an approach of universal ticagrelor use.      The hypothesis is that patients receiving a personalized strategy will have a decreased risk     of bleeding.   "
4656|NCT03224910|"     Cytopathologists work along with radiologist in the diagnosis of lesions. Rapid on site     interpretation (ROSE) of fine needle aspiration (FNA) smears of radiologically suspicious     lesions is a common clinical practice. In the last years, the investigators have seen trend     towards needle core biopsies of radiologically suspicious lesions. The investigators want to     analyze the challenges of rapid on site interpretation of touch imprints (TI) of needle core     biopsies (NCB) versus fine needle aspiration smears.   "
4679|NCT03224611|"     Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to     insert in correct position because of it's flexible structure. Especially in classical way of     manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal     position, we could not guarantee the correct position of the LMA. Therefore several studies     have been investigated to improve this.      The light wand is a kind of stylet which have a light on the tip. Recently some studies     demonstrated the usefulness of the light wand which could be used for indicating correct     position of the LMA. We hypothesised there will be two advantages if the light wand is used     as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible     LMA, and second the lightness could confirm the correct position of the flexible LMA.   "
4657|NCT03224897|"     This study aims to investigate the role of the left ventrolateral prefrontal cortex (VLPFC)     on cognitive reappraisal, using the reinterpretation strategy. For this purpose, we will     produce direct disturbance to the activity of this area through anodal and cathodal     transcranial direct current stimulation during a reinterpretation task.      A double-blind randomized sham-controlled trial will be conducted. 60 healthy volunteers will     be allocated into three groups. Each group will receive one type of stimulation (anodal,     cathodal or sham) while accomplishing a cognitive task on reinterpretation using images from     the International Affective Pictures System (IAPS). The task consists in applying a given     emotional regulation condition (downregulate, upregulate or maintain emotions) to a series of     images and ranking the intensity of the emotional arousal felt after doing this procedure to     each picture. The effects of tDCS on the subjective evaluation of emotional arousal after     reinterpretation in each group will be compared.   "
4658|NCT03224884|"     Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder     surgery. However it is associated with a high incidence of hemidiaphragmatic paralysis (HDP)     that may not be tolerated by patients with chronic pulmonary disease.      This randomized controlled trial will compare ultrasound-guided interscalene block (ISB) and     supraclavicular block in patients undergoing arthroscopic shoulder surgery.      The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit     (PACU) as measured by a numerical rate scale (NRS) from 0 to 10.      Our research hypothesis is that interscalene and supraclavicular blocks will result in     equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set     at 2 points   "
4660|NCT03224858|"     This is a prospective randomized wait-list control study to determine whether a stand-alone,     co-located team of physician, mental health behaviorist, and care coordinators with decreased     panel size (aka intensive primary care) will reduce inpatient and emergency care     utilization, inpatient costs of care, and improve patient activation and experience for     medically and socially complex patients, compared to enhanced usual care at 6 and 12 months.     Participants with multiple co-morbidities, and meet utilization criteria will have the     opportunity to enroll; half the participants will start the intervention immediately, while     half will continue enhanced usual care for 6 months before beginning the intervention.   "
4661|NCT03224845|"     Anxiety disorders usually start in childhood and adolescence and are associated with social     and occupational difficulties in adulthood. Children who have a parent with an anxiety     disorder and who find new situations distressing and avoid them are at an increased risk for     developing an anxiety disorder. Research suggests that anti-anxiety parenting can help     children grow up courageous and calm. It is, however, difficult to parent in an anti-anxiety     way when the parent has an anxiety disorder himself or herself.      This research study will test the efficacy of a new program designed to prevent the onset or     persistence of anxiety disorders in children at risk for anxiety disorders. The investigators     will first help parents learn skills to cope with their own anxiety and then coach them to     share these skills with their children and parent in an anti-anxiety way. The goal is to     intervene early enough in the children's lives so that they can be free of anxiety disorders     and lead happy, healthy and productive lives in adulthood.   "
4662|NCT03224832|"     The definitions for R0 and R1 margin status after resection for pancreatic cancer are     controversial.Various studies showed the rate of noncurative resections of 15- 35 % but with     modified pathological examination (R1/R2) revealed the rate of R1 resection was higher     ranging from 76-85 % .      Verbeke CS etal.        -  Whether this discrepancy was caused by incomplete lymphnode dissection, perineural          dissection and improper pathological examination was not yet known.        -  Perineural invasion was detected in 77 % of specimens of resected pancreatic cancers.      So the researchers emphasized the need of new surgical classification involving mesopancreas.     It can be considered as an anatomical space bounded anteriorly by the the posterior surface     of the pancreatic neck, posteriorly by the pancreaticoduodenal coalescence fascia, medially     by the mesenteric vessels with -nerves, lymphatics and vessels as its contents.   "
4663|NCT03224819|"     This is a first-in-human, open-label, phase 1, sequential dose escalation study. AMG 673 will     be evaluated as a short term intravenous (IV) infusion in adult subjects with     relapsed/refractory AML. The study will be conducted at approximately 7 sites in the United     States, Australia and Germany.   "
4664|NCT03224806|"     Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to     their physiological beneficial effects on human health. But, little information is available     between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in     foods. The present study investigated the effect of enriching white wheat flour with wheat     bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich     bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of     bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were     studied on 4 separate days with each subject testing all 4 types of bread. On each test day     subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood     samples, they ate a portion of one of the breads containing 50g available carbohydrate and     had further blood samples at intervals over 2 hours. They also rated their feelings of     satiety fasting and at intervals over 2 hours.   "
4665|NCT03224793|"     To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in     healthy Japanese subjects.   "
7165|NCT03192085|"     This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the     glaucoma screening clinic at the RD&E hospital.   "
4666|NCT03224780|"     Placenta accreta is a potentially life-threatening obstetric condition that requires a     multidisciplinary approach to management.Diagnosis of placenta accreta before delivery     minimizes potential maternal or neonatal morbidity and mortality. In this study the     researchers will evaluate the role and cost effectiveness of biochemical marker as creatine     kinase in comparison with 3D Doppler ultrasound in antenatal diagnosis of placenta accreta     and its variants in patients with placenta previa totalis.   "
4667|NCT03224767|"     This phase II trial studies how well vemurafenib and cobimetinib work in treating patients     with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
4669|NCT03224741|"     The investigators propose to conduct a randomized controlled trial in collaboration with the     Fundacion Raices, a non-governmental organization (NGO) with strong ties to the local     community of Esmeraldas, Ecuador. A total of about 3,000 subjects will be involved in the     full-scale study over the course of 2 years. In partnership with the Fundacion Raices, the     research team will set up stands at four public places in the city of Esmeraldas: the     malecon (esplanade on the town's waterfront), the Centro Comercial Multiplaza     (Esmeraldas' large shopping mall), the municipal market (a popular destination for groceries,     etc.), and a public park located in the city center. Each stand will feature a sign inviting     individuals to stop and get their health checked, and will provide free refreshments (juice     boxes and water). A monitor will approach individuals at the malecon/shopping     center/municipal market/public park and ask whether they are interested to learn about a     health initiative by the Fundacion Raices and a group of public health researchers. If an     individual is interested, the monitor will begin the three steps of the experiment:        1. Participants fill out a brief, anonymous survey with demographics, socio- economic          characteristics, and whether they have been tested for HIV/AIDS in the past.        2. Participants receive the script and actions associated with the experimental condition          into which they are assigned to according to the randomization table.           There are three experimental conditions:           T1 = Information. T2 = Active Choice. T3 = Monetary incentive.        3. Whether participants subsequently showed up at a medical facility to get tested for          HIV/AIDS is noted in the record.   "
4670|NCT03224728|"     Purpose: To compare the effect of spherical aberration on optical quality in eyes with two     different aspherical intraocular lenses Methods: In this prospective, randomized clinical     trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an     aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting     aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months     after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well     as tilt and decentration measurements with Visante anterior segment OCT were performed.   "
4671|NCT03224715|"     It is well known that ultraviolet (UV) light causes sunburn and DNA damage that can lead to     skin cancer. Despite preventative measures of sunscreens and other topicals the incidence of     skin cancers continues to increase every year. Chronic exposure can lead to development of     both basal and squamous cell carcinoma that also is correlated to the risk of melanoma. When     epidermal keratinocytes are exposed to UV radiation, they form cyclobutane pyrimidine dimmers     (CPDs), 6-pyrimidine-4-pyrimidones (6-4-PPs), and oxygen radicals that alter the structure of     nucleotides. When these lesions are not repaired, DNA replication is altered that leads to     mutations in p53 and PTCH tumor suppressor gene and ultimately tumor development. It has been     discovered that intracellular delivery of bacterial DNA incision repair enzyme T4     endonuclease V DNA repair enzymes can repair sun induced damaged DNA in patients with     xeroderma pigmentosum4,. Yarosh et al also showed that T4 endonuclease V DNA repair enzymes     are specific to reducing the amount of cyclobutane pyrimidine dimers and were found to lower     the rate of new actinic keratoses compared to placebo lotion by 68% with no adverse effects     observed. Additionally Yarosh et al also showed that T4N5 liposomes can repair keratinocyte     DNA in skin cancer patients. This study will examine if pretreating actinic cheilitis with     DNA repair enzyme cream before standard treatments can decrease the need for additional and     possibly more aggressive therapies, decrease the surface area of affected areas, and possibly     improve skin thickening and texture.   "
4672|NCT03224702|"     This First-In-Human trial will be conducted in healthy male subjects to explore the safety,     tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of single doses of     M6495.   "
4673|NCT03224689|"     Prospective, multi-centre, non-comparative, post-market surveillance clinical study   "
4674|NCT03224676|"     Aim of the study was to assess the quality of sleep among adult patients, to explore the     perceived sleep distractors among adult patients, to determine the relationship between     quality of sleep and perceived sleep distractors score among adult patients.      and to determine the association of quality of sleep and perceived sleep distractors score     among adult patients with selected variables.   "
4675|NCT03224663|"     The study evaluates the effectiveness of Module based learning and Mobile application based     learning regarding Facility based newborn care among nursing students.Total 70 Nursing     students were randomly allocated to MBL and MABL group . First 35 students received MBL based     teaching and next 35 students received MABL teaching.   "
4676|NCT03224650|"     The investigators are prospectively validating a prognostic clinical tool that uses a     patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict     survival, post-treatment morbidity, and functional outcomes in patients with metastatic     disease involving the spine.   "
4677|NCT03224637|"     Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful     conditions. There have been a few attempts to use RF current for the treatment of painful     conditions of joints of the extremities. It was also used for the treatment of painful     conditions of the hip joint.   "
6731|NCT03197779|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV     infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.   "
4678|NCT03224624|"     Hypertension is the most common medical problem among US Veterans. Treatment is available and     effective, but control rates remain under 75%. While blood pressure control has traditionally     been achieved through sequential visits and medication changes initiated by providers during     office-based care, self-monitoring and self-management of blood pressure medication is an     important strategy that would empower Veterans to achieve better control of blood pressure.     The health impacts of better systems for treatment of hypertension are significant, including     decreased rates of cardiovascular and kidney disease.      This two-site clinical trial will randomize 400 Veterans to either usual blood pressure care     or a self-management strategy in which patient-driven self-management of blood pressure     medications will be taught and used over the course of 1 year.   "
4680|NCT03224598|"     Evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment     of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.   "
4687|NCT03224507|"     Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic     malignancy in the U.S. No standard curative therapy has yet been found. A variety of     therapeutic measures including high dose melphalan, induction therapy, and continuous therapy     have been used but the goal of complete response without relapse has not been achieved. More     active treatment regimens and better tools for response assessment are needed.   "
4688|NCT03224494|"     BACKGROUND & AIMS: Bowel hypersensitivity (lower threshold for discomfort in response to     distention of a balloon in the rectum compared to healthy controls) is a key documented     feature in Irritable Bowel Syndrome (IBS) mechanistic studies. The use of the barostat     catheter to assess bowel hypersensitivity has been well documented in research settings, but     it's use is time consuming which makes it unpractical for routine clinical practice (test     time up to 60 minutes). The Rapid Barostat Bag is a novel device used to obtain a rapid and     simple assessment of the rectal function, which has received approval for use by Health     Canada. Although its safety and use has been validated in healthy controls, RBB use has never     been reported in a cohort of IBS patients. The aim of this study is to 1) evaluate bowel     sensitivity in IBS patients, compared with healthy controls and 2) determine whether the     sensory threshold predicts response to standard of care interventions such as diet or     medications.      METHODS: This is a prospective controlled study. All participants will undergo RBB testing     and will answer a questionnaire related to bowel symptoms (IBS-SSS - IBS Severity Scoring     System) and a questionnaire related to anxiety/depression (HADS - Hospital and Anxiety and     Depression Scale).      HYPOTHESIS: The investigators hypothesize that IBS patients will display lower bowel     sensitivity thresholds than healthy controls, using the RBB device. Furthermore, we predict     that those with a low sensory threshold (i.e. visceral hypersensitivity) are most likely to     respond to interventions that decrease bowel distention (e.g. low FODMAP diet) or the     medication linaclotide that is reported to decrease pain signaling.   "
4699|NCT03224351|"     This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor     (TEZ/IVA)-controlled, parallel-group, 2-part, multicenter study designed to evaluate the     safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with     cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane     conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del     mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or     TEZ/IVA (F/MF genotypes).   "
4700|NCT03224338|"     Multicenter, single-arm, open-label clinical trial to evaluate the efficacy, the safety and     the tolerability of 50 mg dolutegravir once daily (q.d.) given in combination with 2 NRTIs     backbone in HIV-2 positive, treatment-naïve subjects.   "
4701|NCT03224325|"     The purpose of this study is to evaluate the safety and tolerability of TAK-831 when     administered as multiple oral doses at escalating dose levels in healthy participants.   "
4689|NCT03224481|"     Participants will be recruited for inclusion at a routine adjustment appointment prior to     planned removal of the appliances. Following removal of the appliances, consenting     participants will be randomly allocated to one of two groups by computer-generated random     allocation. Allocation will be concealed from the treating clinician using of an opaque     sealed envelope system. Standard stone model records will be available for all participants     following removal of the appliances (T0).      Participants in both groups will have follow-up scheduled for 3 (T1), 6 (T2) and 12 (T3)     months following removal of the braces. All participants will be instructed to wear standard     clear, plastic (Essix-type) retainers on a full-time basis for 6 months, followed by     night-time wear for a further 6 months. A micro-electronic timer will be integrated within     the upper Essix-type retainer. All participants will be given standard advice at each recall     visit.      Participants in the intervention group will receive tailored electronic reminders. The     frequency and content of the reminders will be informed by qualitative interviews involving     participants from an allied trial, and from posts related to orthodontic retainers shared on     social media. Instructions on the necessary duration of retention, maintenance of retainers,     departmental details, allied to advice on appropriate management for appliance breakages, and     delineation of the implication of suboptimal retainer wear may also be included. Participants     in the control group will not receive additional reminders. Treating clinicians will be kept     blind to the study group.      All patients failing an appointment will be sent another. Those wishing to withdraw from the     trial may do so at any point without affecting continuing care with records taken at the     point of withdrawal from the study with data analysis on an intention to treat basis.      Thereafter, patient experiences with electronic reminders will be evaluated on a subset of     participants using one-to-one interviews.   "
4690|NCT03224468|"     This study will use a randomized controlled design to test whether patients who use medical     marijuana, compared to a waitlist control group, experience a change in health outcomes     (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use     disorders, neurocognitive impairments) or brain-based changes.   "
4691|NCT03224455|"     In this research study, investigators want to learn more about the factors that influence     children's breathing during sleep and their sleep quality. Specifically, investigators are     interested in factors that are related to risk of snoring, sleep apnea (a condition where     breathing stops during sleep), and poor sleep quality.   "
4692|NCT03224442|"     Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF     Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical     Trial.   "
4693|NCT03224429|"     The purpose of this study is to gather decision making needs information from caregivers and     patients with sickle cell disease (SCD) in order to develop a web-based decision aid tool.     Study subjects will participate in interviews defining treatment decision making needs during     which investigators will ask information about their SCD. Notes taken from these interviews     will allow the research team to better understand current practice related to clinical     practice and allow for better refinement of the decision aid tool.      An additional group of participants will be asked to review the web-based Sickle Cell     Decision Aid. Participants will be asked to describe thoughts about the site, including but     not limited to ease of navigation, content and construction.      This study will provide information for the conduct of a randomized controlled trial for the     use of a web based decision aid to give patients with sickle cell disease and parent/legal     guardian of children with sickle cell disease accurate information about risks and benefits     of therapies and enable them to make decisions based on their individual values and     preferences.   "
4735|NCT03223883|"     The proposed research is clinical study evaluating the therapeutic benefits of curcumin on     vascular function in patients with chronic kidney disease (CKD). The study aims to establish     that curcumin will improve endothelial function and reduce large artery stiffness by reducing     oxidative stress and in conjunction with lowering markers of inflammation and oxidative     stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive     function in patients with CKD.   "
4694|NCT03224416|"     For decades, men who have sex with men (MSM) have carried the heaviest burden associated with     the HIV epidemic in the United States. Although MSM represent a minority (i.e., approximately     4%) of the male population in the United States, in 2010 MSM accounted for 78% of new HIV     infections among males. Furthermore, the estimated number of new HIV infections attributed to     male-to-male sexual contact is currently rising. In order to improve interventions to     decrease transmission of HIV among MSM, it is important to have a better understanding of     predictors of risky sexual behavior. Alcohol use is among the most reliable predictors of     risky sexual behavior. Unfortunately, studies of alcohol use and risky sex among MSM have     mainly relied on survey-based methods that cannot advance our understanding of the causal     mechanisms linking acute alcohol use to HIV risk behavior.      This study will utilize an alcohol/placebo/nonalcohol design to examine the mechanisms     underlying the association between the acute effects of alcohol (i.e., pharmacological and     expectancy) and risky sexual decision making in MSM. Focal mechanisms include sex-specific     delay discounting (SSDD), and the core constructs of the Cognitive Mediation Model. The     alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target     BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive     beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in     his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told     he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from     a vodka bottle) and tonic water, with a minimal amount of vodka floated on the surface     (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and     mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true     control (or nonalcohol) condition, the participant will be told he is receiving no alcohol     and will be given water (poured in his presence) in a volume comparable to the other     conditions. This 3-group design will enable us to test the pharmacological effects of alcohol     while accounting for potential expectancy effects. Participants (Target N = 150-180) will be     randomly assigned to one condition; all will undergo the same protocol, which will be     completed within one experimental session. The study protocol consists of baseline     assessment, followed by beverage administration, followed by post-drinking assessment of SSDD     and sexual decision making, followed by debriefing.   "
4695|NCT03224403|"     To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as     two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen     administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen     administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental     pain model following third-molar extractions.   "
4696|NCT03224390|"     The specific aim of this pilot study is to estimate the impact of a new digital health     service on the uptake of family planning among Kenyan women with an unmet need for     contraception. Enrolled women will be randomized to a control arm or an encouragement arm     that will receive a special invitation to try the new service.   "
4697|NCT03224377|"     Rheumatoid arthritis (RA) is a chronic systemic disease affecting primarily the synovium,     leading to joint damage and bone destruction(Gravallese E,2002). It is probably the most     common autoimmune disease, It is three times more common in women compared to men and usually     appears in middle age(poulsom and charles, 2016) .Early diagnosis of RA and its early     treatment with disease-modifying anti rheumatic drugs lead to better control and less joint     damage .therefore,It is very important to find an acceptable serological marker in order to     make an early diagnosis and initiate early treatment to avoid complication and disability (     Orozco C,and Olsen,2006)      Various serum biomarkers are used to diagnose RA, including many autoantibodies. However,     only rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) antibodies have     wide acceptance (taylor et 2011).   "
4698|NCT03224364|"     To determine the safety and feasibility of solo laparoscopic appendectomy, which is defined     as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive     non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).   "
4702|NCT03224312|"     We aimed to assess the target organs damage of hypertention and the occurrence of     cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the     influences of the risk factors.   "
4704|NCT03224286|"     This is a pilot study that provides the investigators with an opportunity to assess the     application of PSM technology for patient monitoring in the NICU. This is a prospective,     observational, cohort study.The investigators expect the duration of infant participation in     this study to be 6 hours per single recording session with no follow-up required.   "
4705|NCT03224273|"     in the last years, dentistry is going to the concept of conservatism to preserve the most     amount of tooth structure, so the evolution of new ceramic materials with invasive designs     like (inlay- shaped and proximal box shaped) inlay retained bridge, we can restore single     missing posterior teeth with less invasive techniques and less rate of restoration fracture.   "
4706|NCT03224260|"     Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese     participants after multiple doses are administered.   "
4707|NCT03224247|"     Cesarean section is one of the oldest surgical interventions in the history of medicine.Many     variations in cesarean section technique have been studied.The investigatory team are aiming     to decrease blood loss during cesarean section by vertical splitting versus transverse     cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.   "
4708|NCT03224234|"     Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes;     thus it is important to identify patients at risk and to develop strategies and tools to     increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of     Insulclock® - small electronic device to help track date, time and dosage of the last     injection, type of insulin used and temperature, with an alarm system to prevent insulin     omissions and mistiming.   "
4709|NCT03224221|"     We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined     with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma     after the failure of conventional treatments.   "
4722|NCT03224052|"     While World Health Organization (WHO) guidelines recommend empirical antibacterial therapy as     the standard of care in all African children with severe falciparum malaria, there are fewer     data to guide the management of adults with the disease in low transmission settings.      Presently WHO guidelines do not recommend empirical antibacterial therapy in adults with     malaria in low transmission settings, instead antibacterial therapy is only clearly     recommended in those patients in whom a serious bacterial co-infection is clinically     suspected. However, in a pilot study in Myanmar (High Frequency of Clinically Significant     Bacteremia in Adults Hospitalized With Falciparum Malaria PMID: 26989752) we found that 13%     of adults hospitalized with falciparum malaria were bacteremic, with bacterial co-infection     suspected by clinicians in the minority. Patients with serious bacterial infection are     commonly not bacteraemic and so this probably underestimates the frequency of significant     bacterial co-infection.      In that pilot study, over 75% of patients received empirical antibacterial therapy on     admission to hospital, which would not accord with published WHO guidelines as clinicians     suspected bacterial co-infection in only 17%. However, the study's 100% survival rate - when     over half of the patients were at high risk of death - suggests that the administration of     antibacterial therapy may be appropriate until bacterial co-infection is excluded.      There is also academic debate about the role of co-morbidities in the presentation of     patients severely ill with vivax malaria. Bacterial co-infection has been reported in some -     but by no means all - studies of severe vivax infection. It would be useful to determine the     relative contribution of bacterial co-infection to the clinical presentation of patients with     vivax malaria.      By systematically seeking evidence of bacterial co-infection in all patients hospitalized at     the study sites, this study aims to determine if the bacterial infection is really as     prevalent as was the case in the pilot study. Accordingly it aims to determine the utility of     a strategy that includes empirical antibacterial therapy in adults hospitalized with malaria     in low transmission settings, until significant bactrila infection has been excluded.   "
4710|NCT03224208|"     In the BRIM-3 trial, which was conducted in patients with previously untreated advanced     melanoma harboring the BRAF V600E mutation, vemurafenib, a potent inhibitor of mutated BRAF,     was associated with prolonged overall survival (OS) and progression-free survival (PFS)     compared to dacarbazine. In the same setting, combined use of vemurafenib and cobimetinib, a     selective inhibitor of MEK, yielded a significant improvement in PFS and response rate,     compared to vemurafenib monotherapy, along with an advantage in OS, which did not cross the     pre-specified significance bounderies (COBRIM trial). In treatment-naïve patients with     mutated BRAF, both anti PD-1-based immunotherapy and BRAF-targeted agents are feasible     therapeutic options, with the former and latter agents being associated with more durable and     earlier responses, respectively.      As suggested by National Comprehensive Cancer Network (NCCN) guidelines, the use of combined     BRAF and MEK inhibitors in patients with progressive disease after immunotherapy, is also     feasible, but it is not supported by category 1 evidence, in view of the lack of studies     conducted in this setting.      The main objective of this phase II trial is to evaluate the efficacy and safety of the     combined use of vemurafenib plus cobimetinib in advanced melanoma patients who have received     first-line systemic immunotherapy for inoperable locally advanced / metastatic disease.   "
4711|NCT03224195|"     The aim of this study is to explore the patient experience of acute rehabilitation after hip     fracture surgery. We also aim to identify patient perceived barriers to rehabilitation and     recovery after hip fracture surgery. More specifically, the objectives of this study are to:        1. describe the rehabilitation experience of patients who underwent hip fracture surgery          with respect to the frequency, intensity, type, and timing of rehabilitation and        2. identify patient perceived barriers to rehabilitation and recovery related to the          patient, their injury and their health care.      The results of this qualitative study will inform a future feasibility cluster randomised     controlled trial aimed at optimising acute rehabilitation after hip fracture surgery. The     findings will help to strengthen the patient and carergiver centred approach when developing     the intervention to optimise rehabilitation and potentially improve outcomes after hip     fracture surgery.   "
4712|NCT03224182|"     This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola     in patients with low- to intermediate-risk NMIBC, assessed according to the 2016 American     Urology Association (AUA) Guidelines. Specifically, only patients with the following low-to     intermediate risk tumor characteristics will be included in the study.      2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:      Low Risk        -  Low grade solitary Ta ≤3cm: a        -  PUNLMP: a, b      Intermediate Risk        -  Recurrence within 1 year, low-grade Ta: a        -  Solitary low-grade Ta >3 cm: a        -  Low-grade Ta, multifocal: a        -  High-grade Ta, ≤3 cm (solitary tumor): a   "
4713|NCT03224169|"     To screen the prevalence of multidrug resistant organisms among the resident in the     residential care home for the elderly, and assess the practicability of directly observed     hand hygiene in this setting.   "
4714|NCT03224156|"     PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with     DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder     implantation.   "
4715|NCT03224143|"     This study is a randomized single-blind controlled trial with parallel arms.The present study     is based on that previously published by Pezzati and collegues (2014) and it is part of a     larger project focusing on Doll Therapy dissemination in Canton Ticino through team training     and supervision and guidelines definition that led to the establishment of the Ticino Doll     Therapy Group with support of the Canton Office for elderly and home care.      The first hypothesis regards the 30 days-effectiveness efficacy of the Doll Therapy     intervention in reducing symptoms of behavioral disorders (BPSD) that appear in stressful     situations (as in the case of a separation from a professional caregiver) and in reducing     stress as perceived by the treating physician. Another issue to be investigated is whether     the typical way in which a person manifested attachment behaviors during own life (classified     in three types of mental states: secure, insecure and unresolved) is associated, once this     person is in an advanced stage of dementia, with caregiving behaviors of the PWD during the     doll presentation (i.e. caressing the object, talking to it and smiling).   "
4716|NCT03224130|"     Post-discharge nurse phone call   "
4717|NCT03224117|"     evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat   "
4718|NCT03224104|"     This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three     cohorts will enroll independently.   "
4719|NCT03224091|"     The PROLED study is a prospective, longitudinal and naturalistic study of patients with     Eating Disorders. Annual interviews and collection of biological samples are done, as well as     during changes in disease course e.g. during hospitalization. Included are qualitative     interviews, psychometric tests, questionnaires which are used to collect data on     psychopathology. There is also collection of blood, urine and faeces.   "
4720|NCT03224078|"     The overall aim of INDEED is to facilitate trans-sectoral and interdisciplinary health     services research of emergency care in Germany.      Clinical hospital data from 15 to 20 emergency departments in Germany will be linked to     routine ambulatory health care data provided by the Association of Statutory Health Insurance     Physicians (Kassenärztliche Vereinigung, KV). INDEED will identify health care gaps and     inadequate resource allocation as well as develop strategies for adaptations of the health     care system to existing demands.   "
4721|NCT03224065|"     Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current     treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic     combination therapy, which is lack of validation of clinical studies. More and more studies     have confirmed that NTM antibiotic resistant gene will affect the efficacy, such as erm(41),     rrl to clarithromycin, rrs to amikacin and so on. This study aimed to compare the efficacy of     guideline recommended therapy and optimized therapy according to antibiotic susceptibility -     related genotype.Genetic testing is accomplished through GenSeizer's high-throughput gene     capture technique.   "
4736|NCT03223870|"     The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm     performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and     Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.   "
4737|NCT03223857|"     To evaluate the visual performance after bilateral implantation of multifocal intraocular     lenses.   "
4723|NCT03224039|"     This study will be a single-center, randomized, controlled trial conducted in the Brooklyn     Hospital Center's Emergency Department (ED) expected to last 2 years. The sample size will be     40 patients with 20 patients in each treatment arm.      The data points to be collected in the study are as follows: baseline characteristics     (baseline pain score, date of birth, age, gender, weight and ethnicity), NRS pain scores at     5, 10, 20, and 30 minutes, dose of study treatment administered, incidence of adverse     effects, time to patient discharge following administration of study treatment, patient     satisfaction of pain control based on a 10-point Likert Scale, number of patients who     required rescue analgesia, and amount of rescue analgesia required. 4.      Once informed consent is obtained, patients will be randomized to receive Treatment A     (sufentanil 0.7 mcg/kg intranasally (IN) and normal saline 1ml IV push) OR Treatment B     (Normal saline 0.6 mL IN and morphine 0.1 mg/kg IV push). It should be noted that during the     study period, use of additional morphine or adjuvant analgesics outside of the designated     time intervals is allowed. The decision to use adjuvant analgesics is the decision of the     attending physician assigned to the patient in the Emergency Department (ED).   "
4724|NCT03224026|"     The study is an observational blinded Validation study in pediatric patients below 3 years     old with a diagnosis of Fever Without Source (FWS). In this study the investigators aim to     validate the performance of a proteomic signature aiding the physicians to discriminate     between viral and bacterial infections in febrile children. The study will also assess the     prevalence of Human Enteroviruses (HEV), Human Parechoviruses (HPeV), Adenovirus (AdV) and     Human Herpesvirus type 6 (HHV-6) viremia, as well as Kingella Kingae bacteremia in the study     cohort.   "
4725|NCT03224013|"     Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis     (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).   "
4726|NCT03224000|"     The goal of this clinical research study is to compare the use of MRI simulations to plan     different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in     patients with low risk human papilloma virus positive oropharyngeal cancer.   "
4727|NCT03223987|"     Before and after study in obese women 25-35 years old, BMI 30-35, taking Strath® Kräuterhefe     Original (liquid), Herbal Yeast Food Supplement for three weeks. At the beginning and after     three weeks of the study a stool sample is provided. These samples are analysed with 16S rRNA     analysis down to species level.The results are interpreted with the PICRUSt classification     and Alpha Diversity Analysis and compared to internationally accepted data bases.   "
4728|NCT03223974|"     The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated     balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate     the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation     lesions when compared with traditional single drug eluting stent(DES) strategy, so as to     simplify the procedure for treatment of coronary bifurcation lesions and extending the     clinical indications of paclitaxel DCB in China.   "
4729|NCT03223961|"     This is an open-label, randomized, multicenter, phase III study      Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO     Alfa 60000 UI/week for at least 12 weeks:        -  Either at diagnosis Or        -  at the Hb threshold chosen for RBC transfusions (must be < 9g/dl)   "
4744|NCT03223766|"     This is a Phase IV clinical trial observing and evaluating the safety of proton therapy in     children. Protocol therapy is not being done as part of this clinical trial. The radiation     targeting, planning, prescribed dose, fractionation, schedule, and use of other forms of     therapy will be done per other therapeutic protocols at St. Jude Children's Research Hospital     (SJCRH) at the discretion of the treating physicians associated with those trials.   "
4730|NCT03223948|"     High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting     flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately     high oxygen concentration should be avoided as there is increasing evidence that the     production of oxygen free radicals can lead to lung damage. This pilot dose finding study     will determine the optimal flow rate and oxygen concentration using HFNO2 for patients with     respiratory failure requiring low, medium or high oxygen concentration from conventional low     flow devices. An assessment will also be made of comfort and compliance with HFNO2.   "
4731|NCT03223935|"     An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety     response in healthy young adults.   "
4732|NCT03223922|"     This is a trial that evaluates the preservation of cognition and neuropsychiatric function     following genu-sparing whole brain radiation in patients with brain metastases.   "
4733|NCT03223909|"     Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ®     Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical     trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by     Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological     characteristics of the ocular surface, as well as its distribution and the characteristics of     the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra     Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).      Controlled, randomized, double-blind, masked clinical study, comparing the safety and     efficacy of preservative-free PR0-087 vs Systane Ultra with preservative and Systane Ultra     preservative free, in subjects with mild to moderate tear film dysfunction syndrome, for a     period of 90 days plus 15 days of remote surveillance, in which one of the three agents will     be administered (PR0-087, Systane® Ultra or Systane® Ultra preservative free) with a q.i.d.     dosage. in both eyes, with regular follow-up visits (5 overall).      Best-corrected visual acuity Intraocular pressure Ocular surface Anterior segment examination     Posterior segment examination Tear film break-up time Schirmer test Corneal epithelization     Goblet cells count Adverse events Subjects with a clinical diagnosis of mild to moderate tear     film dysfunction syndrome between 18 and 90 years old, without concomitant eye diseases nor     requiring different treatments of any of the three interventions in this study They will be     randomized in 3 groups where PRO-087, Systane® Ultra o Systane® Ultra preservative free will     be administered.   "
4734|NCT03223896|"     Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group     B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief     self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis.     Secondary outcome: gambling expenditure.   "
4738|NCT03223844|"     Patients with schizophrenia show enhanced dopamine synthesis capacity and release, an effect     that can be evoked in healthy subjects by repeated amphetamine administration. Therefore for     the first time the relationship between dopamine synthesis and release will be studied in     healthy subjects before and after amphetamine sensitization in order to better understand     adaptive mechanisms of the dopamine system.   "
4739|NCT03223831|"     To compare the efficacy of a novel partially covered (PC) versus uncovered (UC)     pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We     hypothesize that the use of PCDS could reduce the re-intervention rates when compared to     UCDS.   "
4740|NCT03223818|"     Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver     resection remains the mainstay of curative treatment. Post-operative recovery from liver     resection has historically been fraught with a high incidence of complications, ranging from     15-48%, and the high incidence of complications leads to prolonged hospital stay, ranging     from 9 - 15 days, and increase costs of hospitalization. Recent advancement in the     perioperative surgical and anesthetic management of patients undergoing liver resection has     led to improvement in these outcomes.      The investigators department had previously studied the impact and confirmed the benefit of     fast-track peri-operative programs after laparoscopic colorectal surgery. Nevertheless,     studies regarding its adoption in liver resection are limited. The investigators group had     previously reported, in a retrospective cohort, that successful implementation of ERAS     protocol was associated with a significantly shorten hospital stay. However, the     peri-operative management in that study incorporated a small proportion of components     described in ERAS programs for liver resection and there was no direct comparison with     conventional peri-operative program.      The aim of this study is to compare the clinical and immunological outcomes of Hong Kong     Chinese patients undergoing liver resection for liver cancer with a conventional vs a     fast-track perioperative program.   "
4741|NCT03223805|"     This study aims to determine the effects of adding the Respiratory Distress Symptom     Intervention (RDSI) to usual care for the self management of the Respiratory Distress Symptom     Cluster (breathlessness-cough-fatigue) for patients with lung cancer including mesothelioma.   "
4742|NCT03223792|"     This clinical trial will evaluate stool consistency in infants receiving one of two study     formulas through a 14-day feeding period.   "
4743|NCT03223779|"     This research study is studying a drug in combination with radiation therapy as a possible     treatment for hepatic metastases from colorectal cancer.      The interventions involved in this study are:        -  Trifluridine (TAS-102)        -  Radiation Therapy   "
4762|NCT03223532|"     A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0     FRP of Male Circumcision in Resource Limited Settings.   "
4745|NCT03223753|"     This randomized clinical trial studies how well web-based physical activity intervention     works in improving long term health in children and adolescents with newly diagnosed acute     lymphoblastic leukemia that shows a decrease in or disappearance of signs and symptoms.     Regular physical activity after receiving treatment for cancer may help to maintain a healthy     weight and improve energy levels and overall health.   "
4746|NCT03223740|"     Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and     chemoradiation for locally advanced gastric cancer.   "
4747|NCT03223727|"     This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of     CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel     and efficacy of the first subsequent therapy. The indication for treatment with Radium-223     will be at the physician's decision. All patients treated with Radium-223 can be included in     this registry. The registry only dictates the collection of base line characteristics,     expansion of regular blood tests and patient reported pain scores.   "
4748|NCT03223714|"     This study evaluates the efficacy and safety of Conbercept ophthalmic injection. This is a     multi-center, randomized, double-masked, placebo-controlled phase III clinical study. 237     patients with CRVO are expected to be enrolled in the study and randomly assigned into the     Conbercept ophthalmic injection treatment group or the control group at a ratio of 2:1.   "
4749|NCT03223701|"     The purpose of this study is to examine the efficacy of using Solum IV and bone marrow     concentrate with general fluid concentrate in Transforaminal Lumbar Interbody Fusion (TLIF).   "
4750|NCT03223688|"     This study aims to investigate the effectiveness of early intervention program in Department     of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The     investigators assume that the frequency of early-intervention and degree of family     involvement will be associate with the treatment outcome.   "
4751|NCT03223675|"     For newly-diagnosed patients with brain metastasis, whole brain radiation therapy (WBRT)     probably remains a common palliative management even for those with oligometastatic brain     disease. However, WBRT-related late sequelae, particularly a decline in neurocognitive     functions (NCFs), are a major concern. More importantly, in patients with limited brain     metastases and a fair/good performance status, sparing the radiosensitive and vulnerable     structures which are responsible for essential NCFs during the WBRT course is one of the     reasonable strategies to postpone and prevent the development of WBRT-induced neurocognitive     impairments. Actually, radiation-related neurocognitive dysfunction is usually characterized     as a decline involving learning and memory, in which the extremely radiosensitive hippocampus     indeed plays a critical role. In addition to the neurocognitive preservation by virtue of     sparing the radiosensitive structures like the hippocampus, durable intracranial tumor     control critically depends on an escalated radiotherapeutic dose level which is adequate     enough to eradicate gross metastatic brain lesions. Therefore, in order to achieve both     hippocampal sparing and simultaneous integrated boost(s) to gross metastatic foci, a     specialized WBRT technique, hippocampal avoidance during WBRT plus simultaneous integrated     boost (SIB) will be adopted in this prospective study. Moreover, the dose-effect relationship     would be analyzed in order to explore the correlation between the equivalent uniform dose     (EUD) irradiating the hippocampus and the neurocognitive change/decline after the above WBRT     course measured by objective neurocognitive test tools. Newly-diagnosed cancer patients     harboring 1-3 gross metastatic lesions but still in fair/good performance statuses are     potentially eligible. All recruited patients should receive baseline functional brain MRI     examination and baseline neurobehavioral assessment. Treatment planning will be designed via     the technique of volumetric-modulated arc therapy (VMAT) to achieve both hippocampal     avoidance and simultaneous integrated boost(s) to gross metastatic lesions. Except for the     above regions for which conformal avoidance or SIB is attempted, the prescribed dose to the     remaining brain parenchyma will be consistently 3000 cGy in 12 fractions. Accordingly, a     battery of neuropsychological measures, which includes 7 standardized neuropsychological     tests (e.g., executive functions, verbal and non-verbal memory, working memory, and     psychomotor speed), is used to evaluate neurobehavioral functions for our registered     patients. The primary outcome measure is delayed recall, as determined by the change/decline     in verbal memory or non-verbal memory, from the baseline assessment to 4 months after the     start of the WBRT course. This prospective cohort study aims to examine thoroughly the impact     of a specialized WBRT technique, integrating both simultaneous integrated boost(s) delivered     to gross metastatic foci and conformal hippocampal avoidance, on the status of NCF     change/decline in patients with oligometastatic brain disease. It is anticipated that     intracranial local control will be more sustainable and durable resulting from the escalated     focal dose of SIBs. Ultimately, we also expect the dose-effect relationship will be clearly     demonstrated after investigating the correlation between the hippocampal dosimetry and the     status of NCF change/decline after receiving HA-WBRT plus SIB.   "
4753|NCT03223649|"     Background:      Some studies have found that people can better process sugars when they take walking breaks.     Studies have also found that children's attention and memory may improve after exercise. It     is not known if short walking breaks have the same effects. Researchers want to study if     breaking up sitting with walking for 6 days helps children s bodies use sugars and improves     concentration.      Objectives:      To learn if breaking up sedentary (low-activity) time with short walking breaks over 6 days     affects how children s bodies use sugar. To learn if breaking up sedentary time changes     children s attention, memory, feelings, activity, or eating.      Eligibility:      Children ages 7-11 in general good health      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Fasting blood tests. On 2 out of 7 total study visits, participants cannot eat or drink          after 10 p.m. the night before.        -  Full-body X-ray        -  EKG (Electronic signals that record heart function through stickers)        -  Treadmill exercise. Heart, blood pressure, and oxygen will be monitored.        -  Questions about the child s health, socialization, and activity, and parent s education          and economic status        -  Picture vocabulary test        -  Dietician meeting (Questions about eating habits)      Participants will have visits on 6 consecutive days. Over that time, they will wear 2 devices     to monitor blood sugar and activity (even while at home).      Participants will have 5 after-school visits. These include:        -  Health check        -  Snack plus food for the next 24 hours        -  Activity monitored        -  3-hour sitting tests. Participants will do non-active things. Some will have 3-minute          walks every 30 minutes.        -  Cognitive tests and questions about mood and anxiety are given on days #1 & 5.      Participants will fast before the last visit in the morning. They will have:        -  9 blood draws by IV catheter. Participants will drink sugar water.        -  Sitting test        -  Activity monitored        -  Meal (food buffet)   "
4763|NCT03223519|"     The study is designed as a proof of concept, single-center, randomized, double-blind, placebo     controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium +     Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the     treatment of Delayed Onset Muscle Soreness (DOMS).   "
4764|NCT03223506|"     Brain is composed of several anatomical compartments separated by physiological barriers     allowing the maintenance of homeostasis. Furthermore, brain-barriers restrain the diffusion     of some drugs in cerebro spinal fluid (CSF) and in extracellular fluid (ECF) of brain tissue,     making the development and optimization of dosing regimen of new drugs difficult. Most dosing     regimen are determined from the plasma concentration because target site concentrations are     difficult to obtain in the brain, hence making the prediction of the therapeutic effect, the     adverse effect and the toxicity of a brain- diffused drug difficult. Although quantitative     and qualitative differences exist in the processes governing pharmacokinetic (PK) in CSF and     brain tissue, CSF is considered as the best surrogate of drugs penetration in the human     brain.      A study previously published has evaluated in rats the cerebral distribution of paracetamol,     used as a marker of passive diffusion in the ECF by microdialysis in the striatum and in the     CSF by microdialysis in the ventricular lateralis and the cistern magna. Authors chose     paracetamol, as it has the property to diffuse passively and rapidly in the central nervous     system allowing the exclusive description of the relationship between the different     compartments of the brain. This study has first revealed an unexpected important difference     between the distribution profiles obtained in ECF and CSF. Based on these results, authors     developed a physiologically based PK model (PBPK) to describe their results and thereby     offering the possibility to perform interspecies simulations to predict central nervous     system (CNS) distribution of paracetamol in human. In this study, authors used this model to     perform pharmaceutical extrapolations between species converting data from animal to human by     replacing obtained data from clinical past studies describing paracetamol distribution in the     CSF and in plasma.      Microdialysis allows determination of free extracellular concentrations of drug in different     tissues and also in brain. Our research team, INSERM U1070, has several past experiences with     studies involving micro-dialysis to study the distribution of antibiotic in tissue in both     animal and human including cerebral tissue in rat and human. Recommendation from the scholar     society suggests that brain injured patients should benefit from a multimodal monitoring to     optimize their care and brain perfusion. This invasive multimodal monitoring consists of     measuring the intracranial pressure, the oxygen tissue-pressure, the estimation of the     cerebral blood flow-rate by cranial Doppler as well as the monitoring of cerebral ischemic     parameters by microdialysis. We also prevent systemic cerebral aggression among which,     hyperthermia, explaining the prescription of paracetamol among a large number of brain     injured patients. Furthermore setting up of an external ventricular draining (EVD) to treat     an intra cranial hypertension is usually necessary to allow the continuous flow of the excess     of CSF in the brain ventricle.      Few studies carried on human has aimed at comparing the distribution of drugs in both the CSF     and the brain extracellular fluid though it is established that the brain barriers differ in     their permeability as well as the drug's concentrations are different between brain     compartments. Thus by mean of monitoring through microdialysis and/or through therapeutic     EVD, required by brain-injured patients, we aim in our study to explore the pharmacokinetic     of paracetamol in the brain ECF, the CSF and the plasma and to validate in man the PBPK     developed in rat.   "
6241|NCT03204175|"     This study will assess the impact of a school-based water, sanitation, and hygiene management     intervention on toilet use and pupil handwashing in the Philippines.   "
4757|NCT03223597|"     Radium-223 is the 5th treatment for metastasized castration resistant prostate cancer with a     proven overall survival benefit. The improved survival of Radium-223 over placebo was     demonstrated in the ALSYMPCA trial, which included a miscellaneous patient population both     docetaxel pretreated and non-pretreated. This registry aims to describe non-study patients     treated with Radium-223 and prospectively evaluate treatment outcomes of patients with and     without docetaxel pretreatment. Analgesic use and patient reported pain scores, efficacy of     the subsequent therapy and overall survival will be evaluated. Moreover, clinical and     explorative serum and blood biomarkers of Radium-223 efficacy will be explored.   "
4758|NCT03223584|"     Title of the research:      Exploratory study to inventory opportunities to optimize continuity of pharmacotherapy at     hospital discharge      Study area:      Care region Leuven (individual interviews), care region Bruges (individual interviews) and     care region Mortsel (One focus group).      Aims:      From an explorative angle, the study aims to identify hurdles, barriers, facilitators and     needs that general practitioners and community pharmacists experience with patients who have     recently been discharged from a hospital. From a feasibility standpoint, the study aims to     investigate what supportive actions are feasible and useful to optimize the care process upon     hospital discharge. For this purpose, a discharge document for the community pharmacist will     be shown to the healthcare professionals. The HCP will be given the opportunity to give     feedback on this document.      Study design:      A non-interventional, qualitative study is set up using face-to-face, semi-structured     interviews and a focus group.      Study population:      Community pharmacists and general practitioners that are employed in the study region and     that are considered opinion leaders.      Number of health care professionals:      Individual interviews will be organised until there is saturation of information and no new     elements are provided in the interviews. At least five community pharmacists and five general     practitioners will be interviewed per care region. In addition, a focus group will take place     in care region Mortsel.      Procedures:      Upon an informed consent of the healthcare professional, a semi-structured face-to-face     interview will take place. The interview will focus on concrete patient cases, provided by     the healthcare professional, as well as a fictional case of the researcher. In the focus     group, data of the individual interviews will be presented and the relevance and completeness     of the information will be assessed. Finally, the aim of the focus group is to reach a     consensus on the research questions.   "
4759|NCT03223571|"     The investigators believe that the initial cerebral connectivity as well as its evolution     immediate post-stroke could be correlated to the amount of motor recovery. Therefore a cohort     of 21 people early post-stroke, and 6 weeks post standard routine rehabilitation will be     analyzed. Clinical, kinematic and imaging (MRI) data will be compared with 12 healthy     controls. Kinematic movement information has been collected within the fMRI. By integrating     multi-modal clinical, kinematic and MRI, the study aims to identify biomarkers of recovery to     improve patient specific evaluation post-stroke in order to adapt rehabilitation protocols     accordingly and to improve functional gain.   "
4760|NCT03223558|"     The main objective of this trial is to investigate the effects of starting exercise     rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or     Aortic/Mitral valve replacement (VR) surgery.   "
4761|NCT03223545|"     The purpose of this study is to evaluate a mindfulness-based cognitive therapy intervention     delivered over the phone (MBCT-T) for women with prehypertension. MBCT-T is an evidence-based     program that teaches meditation practices and cognitive strategies to reduce stress and     negative emotions. It targets psychosocial risk factors that disproportionately affect women,     including rumination (i.e., negative thinking) and low social support. Investigators plan to     translate the established MBCT-T program into Spanish, conduct focus groups to inform     cultural adaptations that may be needed for Latina women, and run a pilot randomized     controlled trial to test the feasibility, acceptability and effects of MBCT-T on blood     pressure and perceived stress in diverse women with prehypertension.   "
4766|NCT03223480|"     Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering     from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is     associated with a high success and low re-intervention rates, there is a risk of morbidities     (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic     stent (DSEMS) is an alternative to surgery for the palliating these patients. As compared to     surgery, the procedure is associated with shorter hospital stay, reduced morbidities and     cost. However, the clinical efficacy of DSEMS is limited by several problems. In uncovered     DSEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis.     In covered DSEMS, stent migration occurs at a frequency of 14 - 25% and it is a major     obstacle to stent patency. As a result, randomized trials comparing uncovered DSEMS and     partially or fully covered DSEMS in patients with malignant GOO have reported comparable     stent patency between the two types of stents.      Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using     lumen-apposing stents has been described 12-16. The procedure was associated with a technical     success rate of around 90% and clinical success of 85% to 100%. The procedure holds the     potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of     tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of     re-intervention. However, there is limited data on how EPASS compares to endoscopic stenting.     The aim of the current study is thus to compare prospective data on EPASS versus a historical     group that received DSEMS.   "
4767|NCT03223467|"     Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep     (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue     and morning headache are symptoms of the disease which has severe health effect (Malhotra. et     al. 2012) including increased mortality risk (Ensrud. et al. 2012) and effects on quality of     life (Kuhn. et al. 2017).      Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz. et al.     2010, Edwards. et al. 2010) . Bariatric surgery is known to be a good treatment to achieve a     sustained weight loss but the long term effects of bariatric treatment of obstructive sleep     apnea is not well studied. The aim of this study is therefore to study the long effects of     bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can     be used to predict the severity of the disease.   "
4768|NCT03223454|"     This project aims to investigate the safety and effectiveness of human amniotic epithelial     cells in the treatment of the severe refractory Asherman's syndrome.   "
4801|NCT03223025|"     This randomized, active-controlled, two-armed, open-label, and cross-over trial was designed     to compare efficacy and safety of 0.03 mg/kg/day subcutaneous injections of either     CinnaTropin® or Novo Nordisk growth hormone product in 30 children with Idiopathic Growth     Hormone Deficiency. Patients were randomized to receive one of the products for three months.     After that, each patient crossed over to the other arm to receive the other product for     another three months. The primary objective of this study was to compare the efficacy of     CinnaGen growth hormone (GH) with Nordilet. The secondary objectives of this study were     further comparison and evaluation of efficacy along with safety between CinnaTropin® and     Nordilet®.   "
4769|NCT03223441|"     Vascular stiffness increases as a person ages, due to the repetitive stress that is put on     the vascular system which causes changes in the elasticity of the vessel walls. The increased     stiffness of the arteries puts added stress on the circulatory system. This rise in stiffness     has been shown to be associated with an increased risk of cardiovascular events, in both     presumably healthy patients, as well as elderly patients The current method for assessing     perioperative cardiac risk is the Goldman's Revised Cardiac Risk Index (RCRI). This method,     however, does not include a direct measurement of arterial stiffness. Applanation tonometry     is a non-invasive technique that has been shown to reliably provide indices of arterial     stiffness While the use of applanation tonometry has been widely studied in general medicine,     it is has not been studied for pre-operative risk assessment in surgical patients.      The purpose of this investigation is to examine whether aortic stiffness is an independent     risk factor for developing cardiovascular related adverse events in patients who are having     major surgery under general anesthesia.      Applanation tonometry will be performed on the right carotid and femoral arteries to assess     carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system,     AtCor Medical, Sydney, Australia). The measurement will be obtained before induction of     general anesthesia in the presurgical area. Patients' medical history, intraoperative     hemodynamics, and any postoperative complications will be recorded to determine significant     correlations and relationships. This information will potentially help identify future     patients that might be at greater risk of developing an adverse cardiovascular event     following their surgical procedure.   "
4770|NCT03223428|"     The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS)     patients who are satisfied with their overall symptom control, 6 months after initiating     treatment with telotristat ethyl (XERMELO).   "
4771|NCT03223415|"     Background: There is an urgent need to develop new strategies to prevent Clostridium     difficile infections (CDI). A recent study suggests that a novel infection control bundle (IC     bundle) can lead to a significant decrease in the incidence of CDI in acute-care hospitals.     This IC bundle consists in screening patients for C. difficile carriage upon their admission     combined with implementation of isolation precautions for carriers. Further investigations     are required to confirm these findings.      Objective: To evaluate the feasibility of implementing a multicenter interventional study to     further to investigate the efficacy of this IC bundle.      Methods: Prospective, cluster randomized feasibility trial of 2 infection control strategies     (a standard and an experimental strategy) to reduce transmission of C. difficile among     patients in 20 medical wards in 5 acute-care facilities in Quebec. Wards will be randomized     (1:1) to one of the 2 interventions. Each intervention will be applied to all patients     present on selected wards. The study will be divided into (1) a 3-month baseline period; (2)     a 2-week randomization and implementation period; and (3) an 8-week intervention period.      Intervention: The experimental strategy includes the components of the above-mentioned IC     bundle. The standard strategy will not implement the IC bundle.      Outcomes: As a feasibility study, process evaluation will form the primary and secondary     outcomes. These outcomes will allow to determine whether a future main trial is possible and     desirable.      Hypothesis: We hypothesize that the intervention will be implementable across the study     wards.      Significance: This study is essential to plan a subsequent definitive trial to determine     whether the IC bundle can prevent CDI.   "
4785|NCT03223233|"     The serum procalcitonin levels are important during infections and sepsis. The investigators     aimed to assess its predictive value in terms of post-cesarean wound infection.   "
4786|NCT03223220|"     The investigators plan to undertake a phase II study to investigate the efficacy and side     effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide     neuroprotection in patients diagnosed with acute ischemic stroke.   "
6732|NCT03197766|"     The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for     the treatment of children with Achondroplasia.   "
4772|NCT03223402|"     Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot     study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV     maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2     drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug     trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only     Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration     24 weeks primary observation period after study termination, patients may opt to continue on     the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza,     Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen     Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD      Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal     will be submitted   "
4773|NCT03223389|"     To investigate the effects of different fat metabolites on gut hormone secretion in gastric     bypass operated subjects and BMI-matched controls.   "
4774|NCT03223376|"     Fruquintinib 4mg once daily in 4 weeks treatment cycle (three weeks on and one week off) in     combination with Paclitaxel 80mg/m2 （day1, 8, 15 of 4 weeks cycle) was well tolerated and     demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC     in ph1b/2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in     combination with Paclitaxel in the treatment of patients with aGC who have progressed after     first line standard chemotherapy.   "
4775|NCT03223363|"     To determine the value of principal component analysis in the combined method of     three-dimensional ultrasonography assessing fetal limb volume and circumference and     conventional two-dimensional ultrasonography for prediction of birth weight in southern     Chinese population.   "
4776|NCT03223350|"     This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the     relieve of nausea and vomiting.   "
4802|NCT03223012|"     This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient     reported outcomes and utilization of health resources over 12 months.   "
4803|NCT03222999|"     This study will evaluated the epidemiology and the outcomes of patients suffering     out-of-hospital cardiac arrest with presumed cardiac etiology in Korea.   "
23630|NCT02976350|"     The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in     Heart Failure with preserved Ejection Fraction.   "
4777|NCT03223337|"     Daprodustat (GSK1278863), is a small molecule currently in development for the treatment of     anemia of chronic kidney disease (CKD). Results of the earlier studies shows that liver is     involved in the clearance of Daprodustat and hence, hepatic impairment can affect Daprodustat     levels in the body. This single dose study will assess the effect of liver impairment on the     pharmacokinetics (PK) and pharmacodynamics (PD) of daprodustat. The study will be conducted     in two parts, Part 1 will include subjects with moderate hepatic impairment and matched     healthy control subjects whereas Part 2 will include subjects will either mild or severe     hepatic impairment and matched healthy control subjects. Approximately 8 subjects will be     included in each of the group and all subjects will receive 6 milligram (mg) of daprodustat     as a single oral dose in the fasted state. Total duration of participation in the study for a     subject will be up to 7 weeks.   "
4778|NCT03223324|"     To study the equivalence of the Monica Novii™ Patch System in patients admitted for     threatened pre-term labor and for pre-term labor & delivery from 32 +0 weeks gestation by     determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR),     Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer     (TOCO) UC and photo plethysmograph MHR FDA approved predicates   "
4780|NCT03223298|"     This study aims to determine whether the injection of botulinum toxin A or placebo     (unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain     relief and improved jaw function in those who suffer from myofascial pain disorder. The study     hypothesis is that botulinum toxin A injection is superior to placebo. The specific research     questions are:        1. Is the injection of botulinum toxin A superior to placebo for the improvement in pain?        2. Is the injection of botulinum toxin A superior to placebo for the improvement in          function or quality of life (QOL)?        3. Are there any adverse effects that result from injection of botulinum toxin A or placebo          into the masseters and temporalis muscles? Limited data exists to support the use of          botulinum toxin A in the management of myofascial pain disorder of the masticatory          region. Botulinum toxin A is not FDA approved for intra-muscular injection within the          masticatory region. Its use in the masticatory region is considered off-label but          performed without significant known complications. This study will provide the          opportunity to quantitate and qualitate any complications in a large prospective sample          of patients.   "
4781|NCT03223285|"     The aim of this study is to evaluate the effect of diaphragm's manual therapy in addition to     cervical spine manual therapy in terms of pain, cervical spine range of motion, trigger     points pain pressure threshold, disability and quality of life in patient with chronic     aspecific neck pain.   "
4782|NCT03223272|"     The study is deigned to determine if refractory hypertension is attributable to heightened     sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic     agent, in patients failing other classes of antihypertensive agents.   "
4783|NCT03223259|"     A group of dance educators will attend two dance injury prevention workshops hosted by the     Harkness Center for Dance Injuries (HCDI), NYU Langone Medical Center, during which     participants will learn strategies to help them train their students in safe ways and impart     injury prevention information through their dance classes to their students. The educators     will take pre- and post-workshop tests to assess knowledge and perceptions of dance medicine.     Several weeks later, participants will take a follow-up survey to assess knowledge     implementation and workshop effectiveness.   "
4784|NCT03223246|"     Acetaminophen and ibuprofen are two of the most commonly used medication products among     children <12 years old, and these medications are frequently prescribed for patients leaving     the emergency department (ED), but previous studies have shown that parents often leave the     ED unsure of how to safely dose these medications at home. This study will be a randomized     controlled trial of a brief medication safety intervention, and examining parental knowledge     and implementation of appropriate weight-based dosing.   "
4787|NCT03223207|"     The primary objective of this research is to determine if evaluating CIEDs using CareLink     Express® can lead to shorter time to interrogation in the Emergency Department compared to     evaluation of devices using traditional evaluation procedures. The goal of the research is to     determine if patients evaluated by CareLink Express® have a reduction of time to     interrogation compared to the traditional patient cohort.      Secondary objectives of the study are to determine any significant differences in the two     populations regarding:        1. Health care resource utilization including total charges for ED care.        2. Number of patients leaving the ED without being seen (LWBS) or left without the device          interrogation completed.        3. Device related issues detected.   "
4788|NCT03223194|"     This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent     control clinical study to evaluate the safety and preliminary efficacy of AT342 in subjects     with Crigler-Najjar aged ≥1 year. Subjects will receive a single dose of AT342 and will be     followed for safety and efficacy for 5 years.   "
4789|NCT03223181|"     In this study the investigators aimed to evaluate diagnostic accuracy the scoring tool used     to determine cow's milk protein allergy, the cow's milk related symptom score, is based on     the gastrointestinal, respiratory system and dermatological symptoms being together in young     Turkish children.   "
4790|NCT03223168|"     The purpose of this study is to assess for acute hemodynamic changes after implementation of     noninvasive negative pressure ventilation (as compared with spontaneous respiration) in     pediatric patients with Fontan failure using modern negative pressure ventilators   "
4800|NCT03223038|"     This is a multi-site study of how nutrition is delivered to critically ill patients in     pediatric intensive care units (PICUs) around the world. Each site will include mechanically     ventilated children in their respective PICUs and record the details of what type and amount     of nutrition was received. These details will be compared to goals designated by the     clinicians caring for each patient. Data will be entered in a secure online remote data     capture tool and managed by the lead researchers in Pediatric Critical Care Nutrition at     Boston Children's Hospital, Nilesh Mehta, MD and Lori Bechard, PhD, RD. Data will be analyzed     to better understand how different types and amounts of nutrition impact important PICU     outcomes such as length of stay, ventilator time, incidence of infections, and mortality.   "
4815|NCT03222843|"     A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with     chronic, previously treated ITP. Dosage could be adjusted (2.5~.75 mg/day) to maintain     platelet counts 50~250×109/L   "
4791|NCT03223155|"     Trial Design        -  Patients with stage IV non-small cell lung cancer are randomized to nivolumab/ipilimumab          plus either sequential or concurrent stereotactic body radiotherapy (SBRT).        -  The primary endpoint is the phase I safety endpoint of SBRT dose for each body site.        -  The same starting SBRT dose levels are used in each arm. If two or more patients          experience a dose-limiting toxicity (DLT) at the starting dose level, then the reduced          dose level will be used (Section 7.1—Page 72).        -  DLT is defined as any grade ≥3 toxicity possibly, likely, or definitely related to SBRT          plus nivolumab/ipilimumab (the combination and not the individual components).        -  Irradiated metastases will be grouped into one of five locations, which have different          SBRT doses, and the DLTs will be attributed to the relevant organ system.        -  The starting and decreased SBRT dose levels are found in Table 2 (Page 20).        -  SBRT will be delivered in 3-5 fractions over the course of 1-1.5 weeks.        -  Patients in the sequential arm will begin immunotherapy between 1-7 days after          completion of SBRT        -  Given the accrual data for IRB15-1130, the investigators anticipate that approximately          1/3 of patients will contribute metastasis to 2 locations. Since there are 2 arms, and 5          metastasis locations with 6 patients per location for the starting dose level, this          translates to 40 patients for the starting dose level, and another 40 patients should          each of the 5 locations require de-escalation to the lower dose level.        -  Secondary endpoints include comparisons of efficacy and toxicity between the arms, as          well as interrogation of changes in the immune microenvironment induced by the two          approaches.   "
4792|NCT03223142|"     This study will document for the safety and efficacy of image guided multi-mode precision     ablation system (the combination of cryoablation and radiofrequency ablation) for the     treatment of liver malignant, as well as provide the indicator of antitumor immune response     for liver malignant in China.   "
4793|NCT03223129|"     Bariatric surgery has been proven to be an effective treatment of type 2 diabetes and it has     highlighted to role of the small intestine in glucose homeostasis. Improvement of glucose     homeostasis occurs just a few days after the bariatric surgery, where parts of the small     intestine is bypassed, has been performed. Furthermore, conditioned medium from the duodenum     and the jejunum from both diabetic rodents and humans are able to induce insulin resistance     in normal mice and in myocytes. Hence the hypothesis is that the small intestine secretes     factors that are able to induce insulin resistance.      This project aims to study how orally ingested glucose is able to induce insulin resistance     and if this response differs in patients with normal glucose tolerance, impaired glucose     tolerance and in patients with type 2 diabetes mellitus. To address this question glucose     homeostasis will be studied by comparing whole body glucose uptake during a progressively     increased oral glucose load with a graded glucose infusion where the blood glucose levels     will be kept in the same range as during the oral glucose load in patients with normal     glucose tolerance, impaired glucose tolerance and patients with type 2 diabetes mellitus.      Previous studied have shown that different metabolites and bile acids could be involved the     regulation of glucose homeostasis. Hence, it is possible that the gut regulates metabolites     that could be involved in small intestine-induced insulin resistance described above. The aim     of this research is to study metabolomics in plasma collected during the oral glucose     tolerance test with increasing load of glucose and the graded glucose infusion where plasma     glucose level will be held in the same levels as during the oral glucose tolerance test and     study the differences in patients with normal glucose tolerance, impaired glucose tolerance     and in patients with type 2 diabetes mellitus.      The expected results in this study will demonstrate that the gut plays an important role in     glucose homeostasis and that this system is dysregulated in type 2 diabetes. More     importantly, novel factors derived or regulated from the gut that regulate insulin resistance     and glucose tolerance will be identified which could be possible targets for future     antidiabetic therapies.   "
4794|NCT03223116|"     This study is to evaluate the safety and efficacy of radiofrequency energy procedure for     Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis     grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment     was performed at baseline and 3, 6, 12 months after treatment.   "
4795|NCT03223103|"     The purpose of this study is to use precision medicine in the form of a vaccine, a     mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care     treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).      The study is designed to determine whether this treatment combination is well tolerated and     safe.   "
4796|NCT03223090|"     This project pursues the validation of an innovative strategy to boost language learning,     based on the benefits derived from sensorimotor training.      The common belief of a rigid brain structure in adult life had to be reconsidered during the     last decade. After training, local increase in cerebral cortex volume and thickness, the part     of the brain containing neuronal cells and synapses, has been documented. Research has     established that brain structures active during training expand while learning and return to     baseline afterwards. The transient structural increase is thought to reflect work in     progress within areas involved in learning, meant to integrate new skills in existing neural     circuitries, via strengthening and/or selection of local neuronal connections. My main     hypothesis is that other functions, as long as they rely on the activity of the same brain     territories, can take advantage of this work in progress. To use an allegory, imagine the     restauration of a building (brain area). It can start after the request of improvements from     some of the residents (trained function) and then become the occasion for other tenants     (other functions) to see realized also their own wish for improvements. In the end everybody     will benefit from the restauration, provided that they all live in the same building and     everybody has posed their requests during the work in progress. Out of the allegory, living     in the same building means neural overlap of functions in the brain. The case of motor and     linguistic systems represents, from this perspective, a unique opportunity. State-of-the-art     research 1) proved the existence, and described the temporal evolution of brain plastic     changes during sensorimotor learning, and 2) documented neural overlap and functional     interactions of motor and linguistic systems. This posits solid bases for a crucial step     forward, gravid of important consequences and applications. This project aims to take this     step forward by directly testing the innovative hypothesis that brain changes induced by     sensorimotor learning induce benefits for linguistic functions relying on the same brain     territories.   "
4797|NCT03223077|"     Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can     change bacteria in the gut. Certain individuals with Campylobacter infection are also known     to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS). The researchers are     doing this study to understand if changes in gut bacteria and gut mucosal lining during an     acute infection can help identify individuals who might be at risk for developing problems in     the future.   "
4798|NCT03223064|"     Following curative intended therapy in prostate cancer patients, a high proportion of     patients (approx. 25%) relapse with local and/or distant recurrence. The metastasis of a     lymph node (LN) in a patient with prostate cancer means that the disease has become systemic     with the increased risk of disease progression. Therefore the ability to detect the presence     of LN metastasis is important in terms of disease prognosis and treatment options. In the     past, patients with LN metastasis have had poor prognoses due to the scarcity of accurate     staging techniques and toxic treatment regimens such as radiotherapy. For those patients with     a medium to high risk of having LN metastasis, the current procedure is a bilateral pelvic     lymph node dissection (PLND). This is the standard procedure prior to curative treatment with     either radical prostatectomy or radiation therapy. However, the procedure is not optimal due     to the frequent inability to remove all positive lymph nodes within the dissection area. 41%     of metastatic LN disease is not found, due to these LN being outside the routine surgery     field. As a result, some urologists will perform an extended lymphadenectomy (e-PLND), which     leads to extended operating times and the risk of complications. Also, therapy of LN     metastases has limitations: more than 50% of metastatic LN are outside the routine (RTOG-CTV)     radiation field. Thus the effect of standard LN radiotherapy is limited. Currently used     imaging techniques such as CT and conventional MRI are also not sensitive enough to detect     prostate cancer metastases due to the small size of the nodes (< 8mm).      In this study, patients that undergo a pelvic lymph node dissection will be undergoing a 68Ga     PSMA PET-CT and a nano-MRI prior to surgery. The results of the PSMA PET-CT and the nano-MRI     will be validated using the pathology results of the (PLND).   "
4799|NCT03223051|"     The aim of this randomized study is to develop a new motor assessment of space exploration in     a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3     until 16 years old.   "
4804|NCT03222986|"     Systematic establishment of exosome proteomics in co-culture medium and clinical sepsis     specimens will be done. Ubiquitination-autophagy-apoptosis biomarkers in exosomes will be     detected and correlated to specific organ failure in sepsis. The inflammatory process also     will be validated by cytokines analysis. NTA double markers identification will be a smart     method to understand the exosome subpopulations.   "
4805|NCT03222973|"     To evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks and     to evaluate the effects of BIIB033 versus placebo on additional measures of disability     improvement.   "
4806|NCT03222960|"     This study will be conducted to evaluate the effect of Propolis-containing toothpaste in     comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk     patients.   "
4807|NCT03222947|"     Taybi-Linder syndrome (TALS, OMIM 210710) is a rare autosomal recessive disorder belonging to     the group of microcephalic osteodysplastic primordial dwarfisms (MOPD). This syndrome is     characterized by short stature, skeletal anomalies, severe microcephaly with brain     malformations and facial dysmorphism, and is caused by mutations in RNU4ATAC. Although     RNU4ATAC-associated TALS is a recognizable phenotype, an atypical presentation is sometimes     observed, thus expanding the clinical spectrum (TALS-like phenotype).      This study aims to identify new variants involved in Taybi-Linder syndrome and associated     phenotypes (i.e.TALS-like).      This non interventional study will be performed on patients with no proven mutation of     RNU4ATAC and their blood relatives (19 samples total) by high throughput sequencing and     genetic analysis of already collected deoxyribonucleic acid samples.      Altogether, such a study will allow a better understanding of the molecular mechanisms     responsible for the Taybi-Linder syndrome and Taybi-Linder syndrome-like phenotypes as well     as the pathophysiology of these devastating forms of microcephalic dwarfism.   "
4808|NCT03222934|"     •Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone     tissue that separates it from the surrounding important structures .Detailed, meticulous     preoperative radiological study of sphenoid sinus is the key to successful and safe     functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is     to delineate the sphenoid sinus radiologically using the multislice computed tomography and     to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one     of the most variable of all sinuses and its relation to vital vascular and nervous elements     make its approach a challenge for endoscopic surgeons   "
4809|NCT03222921|"     Weight bearing in 40 patients undergoing open wedge high tibial osteotomy (HTO) will be     studied during 12 weeks for their post-operative weight bearing using a pressure insole.   "
4810|NCT03222908|"     To assess impact of behavioral economic principles of precommitment, implementation     intentions, and social contracting on smoking cessation for patients undergoing surgery.   "
20157|NCT03021720|"     Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of     life with femoral versus radial arterial access   "
4811|NCT03222895|"     Background: Lymph node status is an important prognostic parameter in esophageal carcinoma     and an independent predictor of survival. Distribution of metastatic lymph nodes may vary     with tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy. Surgical     strategy depends on the distribution pattern of nodal metastases but consensus on the extent     of lymphadenectomy differs worldwide. Especially for adenocarcinoma the distribution of lymph     node metastases has not yet been described in large series. Aim of the present study is to     evaluate the distribution of lymph node metastases in esophageal carcinoma specimens     following transthoracic esophagectomy with at least a 2-field lymphadenectomy.      Methods: The TIGER-study is a multinational observational cohort study with 58 participating     centers. All patients with a resectable esophageal or gastro-esophageal junction carcinoma in     whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in     participating centers will be included. All lymph node stations will be excised and     separately sent for pathological examination. Cluster analysis will be performed to identify     patterns of metastases in relation to tumor location, tumor histology, tumor invasion depth     and neoadjuvant therapy.      Conclusion: TIGER will provide a roadmap of the location of lymph node metastases in relation     to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node     metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored     treatment can be developed on the basis of these results, such as the the optimal radiation     field and extent of lymphadenectomy based on the primary tumor characteristics.   "
4812|NCT03222882|"     At present, the evaluation criterion of endometrial receptivity is controversial. The     development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for     diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown     that the window of implantation (WOI) is displaced in only a quarter of these patients and     use of a personalized embryo transfer (pET) on the day designated by ERA improves     reproductive performance with higher cost .what is known to the others'population? The     morphological changes observed on histology for each specific day after ovulation were     described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference     of more than 2 days between the histologic dating and actual day after ovulation is     considered to be ''out of phase''. But such pET studies according to the Noyes criterion in     hormone replacement cycle are lacking . The aim of this study is to explore the     transcriptomic profile of endometrial receptivity in different histological dating of hormone     replacement cycle and its clinical application.   "
4813|NCT03222869|"     This research is being done to determine the resistance across stenosis in the airway.   "
4814|NCT03222856|"     This a multicenter, open-label, phase II clinical trial to assess the efficacy of     pembrolizumab in combination with eribulin in female patients older than 18 years old with     hormone receptor-(HR)positive/HER2-negative metastatic breast cancer (MBC) previously treated     with at least one, but not more than two, prior chemotherapeutic regimens for treatment of     locally recurrent and/or metastatic disease. Prior therapy must have included an     anthracycline and a taxane and prior anti-hormonal therapy is mandatory.      The number of patients to be included is 44 patients at 11 sites. All eligible patients will     be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23     mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle.   "
4816|NCT03222830|"     At present, the evaluation criterion of endometrial receptivity is controversial. The     development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for     diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown     that the window of implantation (WOI) is displaced in only a quarter of these patients and     use of a personalized embryo transfer (pET) on the day designated by ERA improves     reproductive performance with higher cost .what is known to the others'population? The     morphological changes observed on histology for each specific day after ovulation were     described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference     of more than 2 days between the histologic dating and actual day after ovulation is     considered to be ''out of phase''. But such pET studies according to the Noyes criterion are     lacking . The aim of this study is to explore the transcriptomic profile of endometrial     receptivity in different histological dating of natural cycle and its clinical application.   "
4817|NCT03222817|"     The proposed study will examine the implementation of a Human Papillomavirus (HPV)     self-sampling intervention for unscreened and under-screened transgender men and     transmasculine individuals living in South Florida. The study will enroll participants to     receive this cervical cancer screening intervention in community venues. The purpose of this     study is to pilot the self-sampler for feasibility and acceptability within this underserved     population.   "
4818|NCT03222804|"     The purpose of this study is to determine if supplementing healthy term infants delivered     vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days     increases levels of bacteria in infants' stool.   "
4819|NCT03222791|"     The Personalized Nutrition Project for Prediabetes (PNP3) study will investigate whether     personalized diet intervention will improve postprandial blood glucose levels and other     metabolic health factors in individuals with prediabetes as compared with the standard     low-fat diet.   "
4828|NCT03222674|"     The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T     cells immunotherapy in patients who have Muc1, CD33, CD38, CD56, CD117 or CD123 positive AML     that is relapsed or refractory. Another goal of the study is to learn more about the     persistence and function of CAR T cells in the body.   "
4829|NCT03222661|"     The purpose of the study is to compare the final glasses prescription based on refraction     obtained with SVOne device to the final prescription obtained via subjective manifest     refraction.   "
4830|NCT03222648|"     In this single centre non-randomised pilot cohort study we wish to quantify the effect of a     twice weekly, 8 week, structured responsive exercise training programme on exercise     tolerance, symptoms and health related quality of life in patients with Idiopathic Pulmonary     Fibrosis (IPF). We also wish to assess the effect of exercise training on fibrotic processes     causing IPF through measurement of blood biomarkers of disease activity.   "
4820|NCT03222778|"     In the perioperative or critical care of hemodynamically unstable patients, appropriate fluid     resuscitation guided by reliable preload indices is of pivotal importance as only half of     them are fluid responsive, and that empiric fluid administration actually leads to dismal     prognosis. In the continuum of being non-invasive, combinations of tissue Doppler-derived     parameters of early (e') and late (a') diastolic, and peak systolic velocity (s') of the     mitral annulus provide information regarding the systolic dysfunction and preload (e'/s'),     and LV stiffness (e'/a'). Hence, combining LVEDAI with these indices would provide     comprehensive information regarding the LV dimension, preload, and compliance as well as     systolic function. Yet, its role as a preload index has not been tested before. Moreover,     these values can be reliably obtained regardless of the heart rhythm, except for a', and do     not completely rely on heart-lung interaction as opposed to the dynamic indices. Thus, the     aim of this prospective trial is to investigate the role of LVEDAI combined with e', a' and     s' as a preload index in predicting fluid responsiveness in patients scheduled for off-pump     coronary bypass surgery, both in closed- and open-chest conditions.   "
4821|NCT03222765|"     Background: A significant proportion of pre-diabetics, show macro and micro vascular     complications associated with hyperglycaemia. Although many trials have demonstrated the     efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has     evaluated the extent to which mid- and long-term complications can be prevented by early     interventions on hyperglycaemia.      Aims: To assess the long-term effects on multiple complications of hyperglycaemia of early     intensive management of hyperglycaemia with linagliptin, metformin or their combination added     to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in     adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both).      Study Design: Investigator initiated (non-commercial), long-term, multi-centre, randomised,     partially double blinded, placebo controlled, phase-IIIb clinical trial with prospective     blinded outcome evaluation. Participants will be randomised to four parallel arms: 1) LSI + 2     placebo tablets/day; 2) LSI + 2 Metformin tablets of 850 mg/day; 3) LSI + 1 Linagliptin     tablets of 5 mg/day and 1 placebo; 4) LSI + 2 tablets of a fixed-dose combination of     Linagliptin 2.5mg and Metformin 850 /day. Active intervention will last for at least 2 years.      Setting and population: Males and Females with pre-diabetes (IFG, IGT or both) aged 45 to 74     years selected from primary care screening programs in 14 clinical centres from 10 countries:     Australia, Austria, Bulgaria, Greece, Italy, Kuwait, Poland, Serbia, Spain and Turkey and .     (N=1000)      Main Outcomes: The primary endpoint is a combined continous variable: the microvascular     complication índex (MCI) composed by a linear combination of the Early Treatment Diabetic     Retinopathy Study Scale (ETDRS) score (based on retinograms), the level of urinary albumin to     creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by     SUDOSCAN), measured during baseline visit and at 24th and 48th month visits after     randomisation. In addition, serological biomarkers of inflammation, vascular damage,     non-alcoholic fatty liver disease, insulin secretion, measures of quality of life, sleep     quality, neuropsychological evaluation and endothelial function will be also evaluated in a     subset of participants.   "
4822|NCT03222752|"     Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive     Disorder   "
4823|NCT03222739|"     Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time     throughout growth and development and is typically detected through x-ray imaging. Although     effective at visualizing a curve, x-ray imaging is costly and may expose children to     potentially harmful ionizing radiation. This is a 30 patient study to evaluate the     reliability of ultrasound, an imaging technique without radiation, to effectively measure     scoliosis deformities compared to the gold-standard of x-ray.   "
4839|NCT03222531|"     To perform a study (100 patients) utilizing Hepatitis C positive donor hearts for hepatitis C     negative donors with post-operative surveillance and treatment only if a recipient infection     occurs.   "
4840|NCT03222518|"     The purpose of this study is to:      Compare the effect of paracetamol alone against NSAIDs alone against the association of     paracetamol + NSAIDs in the treatment of traumatic pain.   "
4824|NCT03222726|"     Microvascular complications are a major complication of diabetes.Diabetic microvascular     complications can not only lead to chronic kidney disease and retinopathy, but also affect     the quality of life of patients with diabetic nephropathy, which can lead to the death of     diabetic patients.Due to diabetes patient survival for decades, in spite of more than 90% of     time is a life outside the hospital, so the analysis of the effect of outside risk factors     for complications of hospital and progress, and to find effective intervention measures is of     great significance for the prevention and control of diabetic microvascular     complications.Therefore, we use of advanced Internet technology, and analysis of large data     algorithms, and try to keep track of routine indicators such as the patient's urine in real     time in patients' families.      This topic mainly observe movement (step 6000 steps per day or 6000 / week) in patients with     type 2 diabetic kidney disease microvascular end point events, provide the basis for     prevention and control of diabetes kidney complications, clinical significance and treatment     prospects.   "
4825|NCT03222713|"     The Health and Education Ministries of Brazil launched the Health in School Program - PSE -     in 2007. The purpose of the PSE is twofold: articulate the actions of the education and     health systems to identify risk factors and prevent them; and promote the education for     health in the public elementary school system. In the health field, the self-regulation (SR)     construct can contribute to the understanding of life habits which can affect the improvement     of individuals' health. This study aims to present a school-based program, Promotion of     Self-Regulation in Health (SRH), which adds the self-regulation approach to the topics of     healthy eating and oral health of the PSE for elementary school. A study of a randomized     clinical trial enrolling the 5th grade students of public elementary schools from the south     of Brazil is presented. The study has two phases. In Phase 1, teachers and health     professionals will participate in a training program on SRH, and in Phase 2, they will     conduct an intervention in class: Promotion of SRH. The participants were randomly assigned     into three groups: Condition I followed the PSE program, Condition II group followed the PSE     and the SRH program, and the control group did not enroll in either of the health promotion     programs. For the evaluation of the study, the following measures and instruments were     applied: Body Mass Index (BMI), Simplified Oral Hygiene Index (OHI-S), Previous Day Food     Questionnaire (PFDQ), Declarative Knowledge for Health Instrument, Food Preference     Instrument, Student´s Attitudes and Perceptions and Parents Perceptions and Influences on the     Health Instrument, Food Availability and Oral Health Instrument, Self-Regulation for Health     Scale, Self-Efficacy for Health Scale. Students in the three groups will be assessed five     times throughout the year: before the beginning of the intervention program, three months     into intervention, six months into intervention, at the end of the intervention, and,     finally, six months post intervention to check for the impact of the program on children     health.   "
4826|NCT03222700|"     In the present study, The investigators investigated the effect of surgical methods on the     recovery of patients after robotic surgery and open thyroidectomy   "
4827|NCT03222687|"     Henoch-Schönlein purpura (HSP) is the most common vasculitis in children, with an incidence     of approximately 10:100 000 children and a slight male predominance (male-to-female ratio of     1.5:1). Henoch-Schönlein purpura nephritis (HSPN) is the principal cause of morbidity for HSP     and 1%-7% of HSPN patients may progress to renal failure or end-stage renal disease.      Immunosuppressive therapy has become the standard treatment in children with HSPN, however     the use of these drugs are still mainly in an off-label manner in clinical practice.     Tacrolimus, a calcineurin inhibitor, has been recently suggested in the treatment of HSPN in     children. However, the evidence-based clinical data are still limited.      Given the potential benefits and unmet need in clinical practice, the purposes of this pilot     study were to assess effectiveness and safety of tacrolimus in HSPN children and evaluate the     potential impact of CYP3A5.   "
4831|NCT03222635|"     Aim of this prospective multicenter study is to evaluate the safety of an endoscopic     follow-up strategy in patients treated with endoscopic resection (ER) for submucosal     esophageal adenocarcinoma (T1bN0M0 EAC).   "
4834|NCT03222596|"     The most common symptom displayed in patients with multiple sclerosis (MS) is a pronounced     sense of fatigue that can have negative effect on functional ability and quality of life     (QOL).      An important goal of researchers and clinicians involves improving the QOL of individuals     with MS, and the exercise therapy represents potentially modifiable behavior that positively     impacts on pathogenesis of MS and thus the QOL.      However, the main barrier for its application is low motivational level that MS patients     experience due to fatigue with adjacent reduced exercise tolerability and mobility, and     muscle weakness. Getting individuals with MS motivated to engage in continuous physical     activity may be particularly difficult and challenging, especially those with severe     disability or Expanded Disability Status Scale (EDSS 6-8).      Till now, researchers have focused their attention mainly on the moderate or vigorous     intensity of exercise and on cardiorespiratory training in MS patients to achieve     improvements in daily life quality, less indicating the exercise content, and most     importantly, breathing exercises.      In addition, it is investigators intention to make exercise for MS patients more applicable     and accessible, motivational and easier, but most important, productive.      Investigators think that MS patients experience more stress with aerobic exercise or moderate     to high intensity programme exercise, and can hardly keep continuum including endurance     exercise, or treadmill.      Hypothesis:      Investigators hypothesis is that 4-weeks of continuous low demanding or mild exercise     programme with specific content and an accent on breathing exercise can attenuate primary     fatigue in MS patients, especially in those with more severe disability or EDSS from 6-8, and     provide maintenance of exercise motivation. Investigators also propose that important     assistant factor for final goal achievement is social and mental support of the exercise     group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise     motivation and finally make better psychophysical functioning, and thus better QOL.   "
4835|NCT03222583|"     A Phase 3, double-blind (DB), placebo-controlled study to evaluate the efficacy and safety of     ABT-493/ABT-530 in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to     GT6-infected Asian participants with or without human immunodeficiency virus (HIV)     co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN)     (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir     with RBV with or without IFN.   "
4836|NCT03222570|"     The purpose of this study is to evaluate the effectiveness of two adaptive treatment     strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based     psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic     symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and     how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to     participate in a 16-week sequential multiple assignment randomized trial conducted in     outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS     condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition     who are insufficient responders will be randomized a second time to the addition of a     selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per     week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and     36.   "
4837|NCT03222557|"     This is a prospective, randomized, sham-controlled, superiority trial that aimed to     investigate the efficacy of electroacupuncture (EA) in reducing the duration of postoperative     ileus and hospital stay after laparoscopic total mesorectal excision or abdominoperineal     resection for rectal cancer.   "
4838|NCT03222544|"     The investigators designed this prospective, randomized control study to confirm the efficacy     and safety of indocyanine green - mediated photodynamic therapy for diabetic lower limb ulcer     and to explore its mechanism.   "
4842|NCT03222492|"     There is significant unmet need for effective treatment options for Diffuse Cutaneous     Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of     brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and     targeted to the protein CD30 molecule expressed on activated immune cells There is evidence     for CD30 involvement in SSc. This study represents the first step in determining safety and     tolerability of brentuximab vedotin in SSc.   "
4843|NCT03222479|"     Participants were able to use the application the investigators developed for four weeks.     With the application, the participants were able to monitor their stress level and life style     patterns. The participants were also provided personalized stress management techniques     including psychoeducation and cognitive behavioral technique. In 2014, additional relaxation     techniques—abdominal breathing, progressive muscular relaxation, and meditation—were     incorporated. Participants' mental health status and life style patterns were evaluated at     baseline and at 4 weeks. Pre- and post-intervention statuses were compared after adjusting     for degrees of life stress factors. Brief encounter psychosocial instrument (BEPSI-K) score     and Center for Epidemiologic Studies Depression Scale (CES-D) score were used as primary     outcome measures.   "
4844|NCT03222466|"     Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA)     test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline     developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have     disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men     remain confused about screening harms and benefits. One potential contributing factor may be     that PEMs are typically developed by researchers and clinicians and may not address patient     barriers to change. The investigators will assess whether a PSA screening PEM that is     co-created with patients provides added value over PEMs developed using the traditional     approach (i.e., researchers and clinicians develop a PEM with patient involvement in     usability testing only. The investigators will also assess satisfaction with the engagement     process and calculate the costs and resources required for each method (i.e. co-creation,     usability, and recommendations only). This study will generate a PSA screening PEM to help     patients make evidence-based screening decisions. It will also help Ontario organizations,     including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening     and other areas of preventive health care, such as breast and colorectal cancer screening.   "
6733|NCT03197753|"     The aim of this prospective, randomised, controlled clinical trial was to compare immediate     postoperative discomfort, emergence delirium and recovery time of the patients intubated     using either laryngeal mask airway or nasotracheal intubation.   "
4845|NCT03222453|"     In order to study the transplantation effect of hematopoetic stem cells from beta-thalassemia     induced pluripotent stem cells. We applied clinical grade source of autologous hematopoietic     stem cell for the treatment of beta-thalassemia patients, detecting the homing of     hematopoietic stem cell transplantation, the differentiation of hematopoietic stem cells in     vivo and the hemoglobin beta-chain (HBB) protein expression in the body of recovery, etc., as     well as to make a research on the efficacy and safety of hematopoietic stem cells from     beta-thalassemia induced pluripotent stem cells.   "
4846|NCT03222440|"     SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label，single     center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an     investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the     efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in     patients with Locally Advanced Esophageal Squamous Cell Carcinomas。   "
4847|NCT03222427|"     The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it     is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The     study will last at least two weeks for each participant, not including screening.   "
4848|NCT03222414|"     The study will compare agreement of invasive blood pressure measurements with non-invasive     blood pressure measurements measured with a conical blood pressure and large standard upper     arm rectangular cuff in super morbidly obese severely hypertensive (systolic blood pressure >     160 mmHg) parturients.   "
4849|NCT03222401|"     Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled     at a single center for a duration of two months for each subject. Subjects who meet the     enrollment criteria will be randomized to one of four open-label groups: Control (no     treatment) or treatment with F598 at one of three doses. Following F598 administration or     assignment to the Control group, subjects must return to the study site for inoculation with     N. gonorrhoeae within 2 weeks. Once subjects have been inoculated with N. gonorrhoeae, they     will enter the observation phase and will return to the study site daily for up to 5 days. At     the end of the observation phase, definitive antibiotic therapy will be administered. A     follow-up visit will be conducted 3-5 days after definitive antibiotic and a confirmatory     interaction will occur with the subjects 7-10 days after the follow-up to confirm the     subject's response. A final visit will occur approximately 8 weeks after inoculation.   "
4850|NCT03222388|"     Questionnaires are used within urology to objectify disease burden and symptom changes during     therapy. Recent technological improvements, as the smartphone and tablet, create new fill-out     possibilities. However, questionnaires are only validated on paper. In order to use     questionnaires for multiple platforms, electronic validation is needed. The International     Prostate Symptom Score has already been validated on the smartphone. The International Index     of Erectile Function (normal version of 15 questions and short version of 5 questions) is     widely used within urology, however electronic validation is required for usage on electronic     platforms in the future.   "
4871|NCT03222102|"     This study aims to evaluate if the risk of developing ventral hernia after liver     transplantation can be reduced through the prophylactic implantation of a synthetic, fully     resorbable mesh Phasix in the course of liver transplantation.      Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery     without the use of Phasix.      Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months     after liver transplantation. Furthermore, presence of infections, seroma, pain and other     problems in the wound area will be assessed.   "
4872|NCT03222089|"     A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL)     Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.   "
4851|NCT03222375|"     Locomotor, transport and information functions in human body systems are carried out by     active media in autowave regimes! Any living organism is a (micro-macro-mega) hierarchy of     autowave subsystems-an ensemble of loosely coupled subsystems of a simpler structure. From     the highest levels of the hierarchy, Autowave Codes-Signals arrive, which determine the     transitions of subsystems from one autowave regime to another Autowave interaction (of     Complex Coherent Action). Autowave interaction is a process associated with the evolution and     interaction of spatial and wave structures in the active media of the organism.      Chaos in organism functioning tells about health. Periodicity - Autowave reverberator may     presage a disease - Autism Spectrum Disorder; Chaotic nature of oscillations in active media     of physiological systems is more optimal for their vital functions than periodic one.     Firstly, systems that function in chaotic regimes, can re-arrange themselves faster and     easier in case of change of environmental conditions, i.e. the so called adaptive control is     more easily implemented in them. Secondly, spreading of oscillations strength along     comparatively wide frequency band takes place in chaotic regime.      When an organism is young and healthy, physiological systems show the elements of chaotic     behavior, i.e. irregularity and chaotic dynamics are the extremely important characteristics     of health. Decrease in changeability and appearance of stable periodicity of Autowave     reverberator are often connected with Autism.      The main purpose is to study brain plasticity (the changes that occur in the brain through     Autowave reverberator) in children with autism. Research suggests that during development,     the brains of children may change in response to their Autowave reverberator differently than     the brains of typically developing individuals. Investigators want to understand why and how     this difference may contribute to the symptoms of autism spectrum disorder (ASD). In this     study, the investigators will be examining the effects of non-invasive neuromodulation SQUED™     series 28.1 home-use for Treatment of Autowave reverberator of Autism.      Integrative Team World Organization of Medical Synergetics (WOMS) - collaborations between     physicians and researchers with expertise in biostatistics, physics, mathematics,     engineering, and computer science.   "
4852|NCT03222362|"     We reviewed the records of 120 consecutive patients (male and female), aged 85 years and     above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years     01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in     the center until December 2015.   "
4853|NCT03222349|"     The hypothesis of the study is that DBSF will be safe and tolerable in pediatric patients     during the Interictal state (Period A) and the ictal/peri-ictal state (Period B) of Epilepsy,     and pharmacokinetics will be the same during and in-between experiencing seizures.   "
4854|NCT03222336|"     Fabry disease is caused by the deficiency or absence of alpha-galactosidase A (α-Gal A)     activity, leading to progressive deposition of glycosphingolipids, mainly     globotriaosylceramide (Gb3), in the lysosomes of multiple tissues and organs. In Taiwan, Dr.     Niu first revealed a surprisingly high incidence (approximately one in 1,600 males) of a     cardiac variant GLA splicing mutation, IVS4+919G>A, in newborn screening. Patients who     carried the IVS4 + 919G > A mutation and were older than 40 years had a higher prevalence of     hypertrophic cardiomyopathy. Endocardial biopsy of these patients with hypertrophic     cardiomyopathy showed significant Gb3 accumulation in the cardiomyocytes. Although the     hotspot IVS4+919G>A mutation is now being observed with greater frequency, understanding of     the natural course of cardiac variant Fabry disease with this specific mutation remains     limited. Therefore, our study would like to conduct a study to approach the natural history     among patients with Chinese hotspot late-onset Fabry mutation IVS4+919G>A through family     pedigree analysis.   "
4855|NCT03222323|"     The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an ulnar     nerve block. By using healthy volunteers the investigators can perform bilateral ulnar nerve     blocks and thereby control for a systemic effect to clarify if the effect is actually     peripheral or systemic. The investigators hypothesis is that dexmedetomidine as an adjunct to     a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral     mechanism.   "
4857|NCT03222297|"     To evaluate the feasibility of CT perfusion technique to monitor the changes of blood     perfusion in the brain tissue before and after skull repair using titanium mesh. To determine     the best timing for skull repair using the three-dimensional titanium mesh; to compare the     effects of early (1-3 months after decompression) and late-stage (6-12 months after     decompression) skull repair on neurologic rehabilitation.   "
4858|NCT03222284|"     This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes     who use a blood glucose meter as part of their treatment regimen. Participants will have     either two or three visits at HITLAB during the 28-day study period.   "
4859|NCT03222271|"     Invasive mechanical ventilation (IMV) is associated with numerous complications. Hence,     patients should be weaned from the ventilator as early as possible. A number of randomized     controlled trials have addressed whether noninvasive ventilation (NIV) can facilitate weaning     in patients failing spontaneous breathing trials (SBT)s. Compared to invasive weaning, NIV     weaning strategy showed reduced mortality, greater weaning success, less     ventilator-associated pneumonia, shorter length of ICU and hospital stay and less     re-intubation rate.      Most of the previous studies used pressure support ventilation with fixed pressure support,     but no studies published on hybrid NIV modes.      Intelligent Volume Assured Pressure Support (iVAPS) is a recent NIV mode, which achieves a     target alveolar ventilation by adjusting pressure support and respiratory rate automatically.     In iVAPS, the target is alveolar ventilation not the tidal volume, taking into account a     predicted dead space . This new mode has been investigated in stable chronic obstructive     pulmonary disease (COPD) patients with domiciliary NIV and it was comparable to pressure     support ventilation (PSV) regarding improvement in oxygenation, carbon dioxide (CO2) wash and     therapy compliance.      Yet, less numerous studies have been performed on this mode when used for acute respiratory     failure. These studies found that i-VAPS was comparable to PSV as regards PaCO2 and pH     improvements, minute volume, pressure support and respiratory rate. No published data so far     about the role of i-VAPS as a weaning mode in mechanically ventilated patients. So, this     study aims to investigate this new mode in comparison to the standard S/T mode in weaning     COPD patients using NIV.   "
4860|NCT03222258|"     This study evaluates the change of quality of life, treatment decision and utilization of     health care depending on the use of palliative care in advanced cancer patients by a     prospective cohort study. Participants will be separated into different groups by their     intentions for using palliative care. Every participant will carry out the questionnaire per     3 months. This cohort study will be ended a year after each participant enrolls. However, if     the participant didn't survive during this study, the caregivers will be asked to fill out     additional questionnaire after 3 months of the death.   "
5017|NCT03220204|"     The focus of this study is to examine the feasibility, acceptability, and preliminary impact     of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior     intervention in a group of patients with mild to moderate heart failure (HF), compared to a     motivational interviewing- (MI-) based education condition and treatment as usual (TAU).   "
4861|NCT03222245|"     This study is only open to sites in the Wessex CRN. The aim of diabetes treatment is to     achieve and maintain as optimal blood glucose levels as possible to prevent unpleasant     symptoms associated with high blood sugars and long-term complications of diabetes. This can     be achieved with oral tablets, subcutaneous injectable diabetes therapies such as insulin or     GLP-1 analogues.      Injectable therapies can significantly improve glucose control, but the counter to this might     be an increased treatment burden, patient and clinician's inertia to initiate injectable     treatments and the potential side effects of the medications.      These treatment aspects may critically affect patients' health related quality of life and     satisfaction with treatment which can powerfully influence patients' compliance and     self-management behaviours. This is an observational cohort study and its overall aim is to     compare the health status, quality of life (QOL) and treatment satisfaction in two cohorts of     patients with type 2 diabetes - those treated with oral diabetes drugs (nonexposed group) and     those on subcutaneous injectable therapies (exposed group).      The changes in the above parameters will be measured by applying three questionnaires to both     groups of participants at baseline and after 6 months of treatment:        1. ADDQoL measures diabetes specific quality of life        2. DTSQ measures treatment satisfaction        3. SF-36 measures overall health status      Study duration is six months for each participant and over this period participants will     receive three telephone or face to face contacts (based on their preference) with the     research team. The questionnaires will be posted to participants at baseline and at 6 months     and will be completed in paper form and returned to research team in pre-paid selfaddressed     envelopes.      It is hoped that this study will provide valuable understanding of the effect of injectable     therapies on QOL and treatment satisfaction in our local population with type 2 diabetes     which can then be carefully factored into clinical decisions when initiating or intensifying     diabetes treatments.   "
4862|NCT03222232|"     This is an observational study evaluating a catheter salvage strategy in relation to     catheter-related bloodstream infections in patients with chronic intestinal failure dependent     on home parenteral support. The study is confined to the period 2002 to 2016.   "
4863|NCT03222219|"     The objective of this observational study is to evaluate the primary stability of dental     implants. Clinical insertion torque data with the Implant Stability Quotient will be     correlated.   "
4864|NCT03222206|"     This Study purpose to verify change of variety factors that the cause of nonalcoholic fatty     liver disease and its process through salsalate injection to osteoarthritis patient who has     non alcoholic fatty liver   "
4865|NCT03222193|"     The Tongue Right Positioner (TRP Snorless™) is a medical device designed to restore     physiological tongue positions when functioning or at rest and increase tongue muscles tone.     Patient wears TRP Snorless™ daily at least 5 hours during night. Published data suggested     that TRP Snorless™ increases oropharynx diameter and nasal patency, favouring airflow in     upper airways. Independently of patient's adherence to daily myofascial exercises, the TRP     Snorless™ treatment should increase tongue muscles' tone and decrease the risk of snoring     during sleep.   "
4866|NCT03222180|"     The first 2 years of this project consisted of user-centered design and development of an     online resource designed by and for parents of very young children with type 1 diabetes. That     phase of the work is nearing completion so that recruitment can soon begin for the second     phase, which is a randomized controlled trial to evaluate the effects of use of this resource     on a variety of pertinent child and parent outcomes.   "
4882|NCT03221959|"     This is a single centre, observational study with a medical device which has Conformité     Européenne (CE) marking. The aim of the study is to demonstrate that patients with malignant     middle cerebral artery infarction (M-MCA) show an increased intra-cranial pressure (ICP)     compared to neurological patients without M-MCA infarction or other space-occupying     indications.   "
4905|NCT03221660|"     The objective of this study is to evaluate the clinical performance of the new restorative     F-Composite 2 system for Class I and Class II cavities that need to be restored in permanent     teeth.      The materials of the system can be polymerized in short time with a new curing light which is     part of the system.      The study will be carried out as a prospective study, with evaluation of the restorations     after 7-10 days (baseline), at 6 months, at 12 months and at 24 months according to defined     criteria.   "
4867|NCT03222167|"     This is a multi-center, open-label trial of Elbasvir/ Grazoprevir 50/100 mg fixed dose     combination 12 week treatment aimed to evaluate SVR12 in treatment naïve patients with     chronic hepatitis C (genotype 1b) infection, associated with of metabolic syndrome. The study     to be conducted in conformance with Good Clinical Practices.      A total of 60 subjects will be studied at 2 sites in the Republic of Kazakhstan.      Males and Females treatment naïve patients with CHC genotype 1b infection associated with     metabolic syndrome (MS), 18-70 years of age, with or without severe fibrosis / compensated     cirrhosis will be enrolled. SVR 12 (primary endpoint) will be evaluated. Patients will be     stratified by fibrosis stage and presence of metabolic syndrome components. Interim Analysis     will be performed in order to estimate viral kinetics, applicability of SVR4 and durability     of SVR12 by evaluation of virologic response at week 4 and 8 of treatment and follow-up at     week 4 (SVR 4) and 24 will be performed - this will be a descriptive summary only without     hypothesis testing.      The main hypothesis is that 12-week therapy with MK-5172 in combination with MK-8742 for     treatment-naïve patients with HCV genotype 1b with metabolic syndrome is not notably worse     than the same course for treatment-naïve patients with HCV genotype 1b without metabolic     syndrome.   "
4868|NCT03222154|"     The study consisted of 60 women who had pain-point pains in the upper fibers of the trapezius     muscle. They had a medical age of 22.8 years, with a body mass index of 22.8 kg / cm2.They     underwent an initial assessment, with a visual analogue pain scale, followed by an assessment     of pain threshold, and manual muscle strength.Then, they were allocated into three groups:     control group with 20 volunteers without intervention, placebo group with 20 volunteers with     shock wave simulation and an intervention group with 20 volunteers with shock wave therapy.      All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours     after the intervention protocol (48 hour evaluation). A mixed ANOVA of repeated measurements     was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was     set at 5% (p <0.05).   "
4869|NCT03222141|"     The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN     3 transcatheter heart valve and delivery systems which are intended for use in patients with     symptomatic, calcific, severe aortic stenosis, and are in high risk.   "
4870|NCT03222128|"     The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN     3 transcatheter heart valve and delivery systems which are intended for use in patients with     symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.   "
5018|NCT03220191|"     to evaluate the effect of the PPI (rabeprazole) on the PK of a potential commercial tablet     formulation of palbociclib   "
10868|NCT03143660|"     The goal of this study is to investigate whether eight weekly telephone coaching sessions or     materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year     olds.   "
4873|NCT03222076|"     Objectives:      Primary Objective:      1. To evaluate the safety and tolerability of therapy with nivolumab alone or nivolumab +     ipilimumab in resectable HCC in the context of presurgical therapy; to evaluate the safety     and tolerability of therapy with nivolumab + ipilimumab in potentially resectable HCC in the     context of pre-biopsy therapy.      Secondary Objectives:        1. To assess the efficacy of presurgical nivolumab alone or nivolumab + ipilimumab therapy          in HCC by estimating the objective response rate (ORR) and time to progression (TTP) per          RECIST 1.1 progression-free survival (PFS).        2. To estimate the conversion rate to surgery for arm 3 potentially resectable patients.   "
4874|NCT03222063|"     The study evaluates the effectiveness of play interventions on anxiety among hospitalized     children in selected hospital of Yamuna Nagar, Haryana. Quasi experimental approach was     adopted. 60 (30 in experimental and 30 in comparison)hospitalized children were selected by     purposive sampling technique.Hospitalized children in experimental group were provided play     interventions whereas the children in Comparison group received only usual medical and     nursing care.   "
4875|NCT03222050|"     A study to assess and compare the effectiveness of Distraction techniques on Pain intensity     during Immunization among Infants in selected hospital of Ambala, Haryana.   "
4876|NCT03222037|"     This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a     total of 3 visits where all study endpoints will be measured in all subjects at baseline with     habitual lenses and under the two testing treatments sequentially in separate visits based on     the randomization scheme   "
4877|NCT03222024|"     This is a multi-centre, prospective cohort study. The aim of this study is to investigate     causes, risk factors, clinical course, management and outcomes of severe ischaemic stroke in     a real-world setting in tertiary hospitals in China. Patients with acute ischaemic stroke     from nine tertiary hospitals in western China will be recruited. Participants will be visited     within 24 hours after admission, on day 3, day 7 and at discharge, to collect their clinical     data, blood biomarkers, and brain imaging. A structured telephone interview will be conducted     for each participant at 3 months and 1 year after stroke onset, respectively, to collect     their functional outcomes. In-hospital outcomes include haemorrhagic transformation, brain     oedema and death, 3-month and 1-year outcomes include survival status (death or survival) and     functional outcome (scores of modified Rankin scale, mRS).   "
4878|NCT03222011|"     Two thirds of patients with Crohn's disease require intestinal surgery at some time in their     life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring,     are the most common reason for surgery. Despite the high frequency, associated disability,     and cost there are no are no treatment strategies that aim to improve the outcome of this     disease complication. The STRIDENT (stricture definition and treatment) studies aim to     develop such strategies.   "
4879|NCT03221998|"     This study is designed as a population-based prospective randomized cohort study. A     prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid     obesity   "
4880|NCT03221985|"     The research team will investigate whether there is a relation between smartphone usage and     psychological parameters using the smartphone application.   "
4883|NCT03221946|"     Newer drug delivery systems such as transdermal patches using pain relieving or modifying     agents emerged as mainstream treatment protocol for management of pain on the outpatient     basis. The administration of Diclofenac 100 mg in transdermal patch in the patients having     dental pain due to periapical/periodontal infections was evaluated.      Methods: 90 Patients of either gender, between 18 to 80 years were divided into 3 groups     (Group A- oral medication, Group B- transdermal patch, Group C - intra muscular group).     Patients at the dental department with pain from periapical/periodontal pathologies were     explained about the procedure of analgesia. With written consent, 100 mg diclofenac sodium     transdermal patches were prescribed to patients who opted their use in pain control for 2     consecutive days. A Visual Analog Scale was provided for all patients assessing the pain     intensity during the study.   "
4884|NCT03221933|"     To preliminary assess the efficacy and safety of recombinant human growth hormone injection     on the treatment of small for gestational age (SGA), and determine the best dose.   "
4885|NCT03221920|"     This study examine the effects of very low carbohydrate diet (in which the calories     requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow     Prognostic Score), serum lactate and TNF Alpha levels   "
4886|NCT03221907|"     A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical     trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in     peripheral neuropathic pain   "
4887|NCT03221894|"     In China, herbal therapy as a complementary therapy is very popular. Should conventional     therapy (such as donepezil and memantine) combined with herbal therapy make add-on benefit?     Cognition, activities of daily living and behavioral symptoms will be assessed. Data will be     collected from the medical records of patients with Alzheimer's disease (AD) in memory     clinics.   "
4888|NCT03221881|"     In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to     efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with     standard doxorubicin formulation was used. The study aimed to determine whether the     combination of PLD-docetaxel would increase tumour response in patients with breast cancer.   "
4889|NCT03221868|"     The study aims at evaluating the effects of an intervention among diabetic women (40 years or     older) who belong to the Basic Health Units System (Brazilian public health system). The     novelty of this project is that the intervention is low cost and demands very little from the     health system in terms of structure, facilities and personnel.   "
4910|NCT03221595|"     This study evaluates the efficacy of surgical stabilization of rib fractures, as compared to     best medical management, for patients with multiple, displaced rib fractures.      Half of patients will be randomized to surgery (in addition to best medical management),     whereas the other half will be randomized to medical therapy only.      The primary outcome will be the subjects overall quality of life measured at two months     following injury.   "
4911|NCT03221582|"     An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart     risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.   "
4890|NCT03221855|"     It is a double-blind randomized clinical trial placebo-controlled, which aims to assess     whether Domperidone medication helps to increase milk production. The sample of 30 mothers of     newborns in the Neonatal Intensive Care Unit of the Hospital de Clínicas de Porto Alegre for     at least 15 days, receiving power enteral tube (without clinical condition for oral). Nursing     mothers will be evaluated by the researcher (breastfeeding committee member) or consultants     in breastfeeding that will advise these women about the practice of runs out of the breasts     each mother. You receive containers for collection, at least one for each time you run out.     These containers will measure the volume of milk. For each mother that refer insufficient     milk production or is not maintaining adequate production for their newborn within 24 hours,     one will be generated data form and after 15 days postpartum will be randomized and receive     domperidone orally at a dose of 10mg 8/8 hours, or placebo in same volume. The milk volume     will be measured daily. Three blood samples will be collected for each lactating each with 5     ml tube without anticoagulant for analysis of serum prolactin and domperidone. The sample 01     will be collected immediately after randomization, before receiving any medication (placebo x     domperidone). The sample 02 on 5 of the study. And the sample 03, day 10 of the study, three     days after the termination of the use of medication or placebo. A milk sample (5 ml) of each     mother will be collected on day 5 to analysis of domperidone levels in milk. Once collected,     the samples will be processed and frozen at -80o C for later analysis. All mothers will be     followed until hospital discharge of their newborns, to monitor outcome breastfeeding     exclusive breast.   "
4891|NCT03221842|"     This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant     patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase     inhibitor as add-on to standard of care (IVIG).   "
4892|NCT03221829|"     The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among     elderly patients The basic methods for diagnosis and management of bladder cancer include     endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age     of most patients is above 60, which increases the risk of complications during the     perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional,     mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is     questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining     logical communication with a patient during the procedure enables early diagnosis of     complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures     the best pain management in the early post-operative period. The simplicity of performing an     efficacious spinal block and its cost-effectiveness are additional factors, which have     contributed to the acknowledgement of the method as the standard of anaesthesia for     transurethral procedures.   "
4901|NCT03221712|"     The aim of this study is to find strategy for treatment through comparing the cardiopulmonary     exercise test parameters before and after cardiac rehabilitation in patients with chronic     total occlusion of the coronary arteries.   "
4902|NCT03221699|"     Bothersome odor from the axilla is in most cases caused by Corynebacterium spp.     Anti-microbial effects of zinc oxide (ZnO) are well documented.      The overall objective of this study is to verify that repeated applications of a ZnO     containing formulation can be directly linked to reduced growth of Corynebacterium spp. in     the axillae.   "
4903|NCT03221686|"     Collagen synthesis is depressed systemically in the immediate postoperative period. Arginine,     zinc and vitamin C impact collagen synthesis.      The aim of this study is to investigate the effect of a pre and postoperative oral supplement     consisting of arginine, zinc and vitamin C on collagen synthesis in patients undergoing     inguinal hernia repair.   "
4944|NCT03221153|"     In this project, the authors aim to evaluate the use of high fidelity simulation as a method     of evaluation of general skills in fifth year medical students about patient quality and     safety in a hospital setting.   "
4893|NCT03221816|"     Introduction: Cardiovascular diseases (CVD) are the main cause of death in Western countries.     High levels of homocysteine (He) has been considered an important risk factor for coronary     artery disease. Objective: To evaluate the effects of the drug Tenavit® (pyridoxine     hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40 mg) on plasma homocysteine     concentrations and lipid profile in postmenopausal women. Methods: Sixty women were     postmenopausal selected from the outpatient Gynecology Hospital Santa Marcelina that passed     by routine consultations and fulfilling the inclusion criteria were invited to the study. The     women were randomly allocated to control or experimental group (30 in each group) in a do     uble-blind controlled clinical trial. The experimental group received one tablet of Tenavit®     daily and the placebo group received the same tablet with the organoleptic characteristics of     Tenavit® for a period of 4 months. The women were assessed before the intervention and after     4 months of medication. A self-report questionnaire to assess quality of life (QSF-36) was     applied and anthropometric measurements, cholesterol and fractions, triglycerides, fasting     glucose, homocysteine and cysteine were evaluated. Results: The only variable that presented     significant alteration in both dimensions (between and within group) was the homocysteine. It     was observed statistical significant between groups in the final measure for homocysteine     (control group: 11.5mmol/ L; experimental group: 9.4 mmo   "
4894|NCT03221803|"     The purpose of this study aimed to answer a clinical question whether In a patient with     bilateral distal extension area, would the metal framework partial denture with OT vertical     attachment versus partial denture with OT CAP attachment result in better patient     satisfaction?   "
4922|NCT03221439|"     There is evidence, of a single randomized controlled trial, that CFT is better than combined     manual therapy and motor control exercise for chronic low back pain. However, this study had     significant methodological shortcomings regarding the failure to carry out the intention to     treat analysis and a considerable loss of follow-up of patients. It is important to replicate     this study through a randomized clinical trial with similar objectives in another domain, but     correcting these methodological shortcomings. Therefore, the aim of the study is to assess     the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back     pain.   "
5562|NCT03213080|"     The TLD registry is a multicenter, prospective, single-arm post-market release study designed     to record the clinical outcomes of Targeted Lung Denervation (TLD), using the CE-marked     Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This     registry is being conducted in Europe.   "
4895|NCT03221790|"     OBJECTIVE: To gain mechanistic insights, we will compare effects of low fermentable     oligosaccharides, disaccharides and monosaccharides and polyols (FODMAP) and high FODMAP     diets on symptoms and colonic protease expression in patients with diarrhea predominant     irritable bowel syndrome (IBS-D). We will measure how protease changes affect excitability of     pain sensing neurons and correlate this with measurements of the metabolome and the     microbiome.      DESIGN: We aim to perform a single blind prospective study of patients with diarrhea     predominant IBS (Rome IV criteria) who will sequentially consume a high and low FODMAP diets,     each for 3 weeks. Symptoms will be assessed using the IBS symptom severity scoring (IBS-SSS).     Electrophysiological studies of changes in mouse dorsal root ganglia neurons in response to     colonic mucosal/lamina propria supernatants will be carried out. Protease antagonist will be     used to specifically assess protease expression. The metabolome will be evaluated using     metabolic profiling in urine using mass spectrometry. Stool microbiota composition will be     analysed by 16S rRNA gene profiling. All the above testing will be performed at 4 time     points: at baseline, 3 weeks following a run-in period, after a 3-week-long high FODMAP diet,     and after a 3-week-long low FODMAP diet period.      HYPOTHESIS: We anticipate that colonic tissue protease effects on the excitability of dorsal     root ganglia (DRG) neurons will increase with a high FODMAP diet and decrease with a low     FODMAP diet, but that this may not be found in all patients. The magnitude of the effect may     vary and this variation could be due to differences in the individual patients microbiome.   "
4896|NCT03221777|"     Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute     stressor (e.g.      medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with     Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first     presentation of paroxysmal AF and associated with a risk of stroke. AFOTS is a common     occurrence (>40% in some intensive care settings), but there is a lack of evidence to guide     its management and guidelines have called for further research in this area. Retrospective     data suggest that many patients with AFOTS (>50%) will experience recurrent AF. These     estimates were obtained without using sensitive methods for AF detection, which raises the     possibility that the true rate of recurrent AF is much higher. As the rate of recurrent AF     increases, it becomes increasingly likely that AFOTS is just the first detection of typical     clinical AF.      Objective To use a sensitive strategy to determine the rate of recurrent AF among patients     who experienced AFOTS following i) non-cardiac surgery OR ii) medical illness, compared to     matched controls.      Methods Two multi-centre, 138-patient, observational cohorts. AFOTS patients will have new     AF, documented by 12-Lead ECG or surface monitoring, during hospitalization for non- cardiac     surgery (Cohort 1) or medical illness (Cohort 2).      Controls will be patients without a history of AF who are matched for age (within 5 years),     sex and exposure to stressor. Participants will wear a 14-day ECG monitor at 1 and 6 months     after discharge. The endpoint is detection of AF.      Impact      If the incidence of AF after AFOTS is >80%, clinicians could be advised to treat AFOTS like     clinical AF and initiate anticoagulation according to guidelines. Otherwise, a strategy of     surveillance for AF would be advised.      Hypothesis        1. Patients who experience AFOTS will have a higher future incidence of AF and of stroke          compared to patients exposed to a similar stressor but who did not develop AF.        2. The risk of recurrent AF after AFOTS will be sufficiently high (> 80%) to warrant          routine initiation of long-term OAC in all cases.   "
4897|NCT03221764|"     This study will prospectively evaluate the use of an amiodarone releasing hydrogel applied to     the pulmonary veins and atria at the time of lung transplantation. This study will include     patients undergoing lung transplantation at Jewish Hospital, Louisville KY. The prospective     group will be compared to historical controls from the same institution. Investigators will     access medical records and database entries for those patients undergoing lung     transplantation after January 1st 2005 in order to obtain matched controls for analysis.     Informed consent will be obtained from the prospective cohort prior to patient enrollment.     This pilot study will be used to obtain preliminary data in order to proceed with a larger     randomized control trial.   "
4898|NCT03221751|"     Mild traumatic brain injury (mTBI) from explosions is the signature injury of Veterans who     have deployed to the wars in Afghanistan and Iraq. Although the immediate effects of a single     mTBI usually resolve over days or weeks, multiple mTBIs can lead to both persistent symptoms     and, years later, to two fatal progressive brain diseases, chronic traumatic encephalopathy     (CTE) and Alzheimer's disease (AD). It is believed that CTE and AD are caused by nerve     damaging chemicals called tau and beta amyloid produced by the brain but which are not     removed from the brain in a normal manner in persons with mTBIs. The investigators will     determine in Veterans who experienced mTBIs whether a clinically available drug called     prazosin increases removal of tau and beta amyloid from the brain. This will be accomplished     by seeing if prazosin reduces the amount of tau and beta amyloid in the spinal fluid that     surrounds the brain. If the investigators find such reductions, prazosin will be evaluated as     a preventative treatment for CTE and AD in future studies.   "
4899|NCT03221738|"     The investigators are developing and testing a Smartphone-based cognitive behavioral therapy     (CBT) app for body dysmorphic disorder (BDD). The investigators hypothesize that app-based     CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body     image concerns and related outcomes.   "
4900|NCT03221725|"     Surgery for Stage II-III Pelvic organ prolapse   "
4906|NCT03221647|"     Background & Aims The enteropathy in Celiac Disease (CD) is due the adaptive and to the     innate immune response to gliadin peptides. Gliadin peptide P31-43 activates innate immune     response and interferes with vesicular trafficking. Type 1 interferons (INFs) and viral     infections play a role in CD pathogenesis. In this paper investigators investigated the role     of P31-43 in the activation of the INF-α pathway.      Methods Small intestinal biopsies of CD patients both with active disease on gluten     containing diet (GCD) and in remission phase of the disease on a gluten free diet (GFD) and     controls were analyzed before and after culture with P31-43. The levels of toll like receptor     7 (TLR7), myeloid differentiation primary response 88 (MyD88), myxovirus resistance protein 1     (MxA) and nuclear factor-κB (NF-κB) proteins and INF-α mRNA was analyzed in intestinal     biopsies.   "
4907|NCT03221634|"     The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in     combination with daratumumab in participants with relapsed refractory multiple myeloma     (rrMM). The primary outcome measure for this study is the assessment of Objective Response     Rate (ORR) in participants with rrMM.   "
4908|NCT03221621|"     The primary objective of this randomized controlled clinical trial in a real life setting is     to evaluate the cost-utility of limumab monotherapy compared with the combination of     adalimumab and a maximum of three surgeries after two years of treatment in adult patients     with moderate to severe HS.   "
4909|NCT03221608|"     This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy     (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the     standard adjuvant systemic treatment after surgery.   "
4912|NCT03221569|"     The study investigators are attempting to determine if ketamine can offer rapid, complete and     sustained headache relief in the acute setting and 48 hrs post-discharge. The goal of this     study is to enroll 40 patients total (20 per arm). This will be a double-dummy study in     that there will be no placebo only arm. Medications will be administered in a double blind     randomized fashion. Each patient will receive an intranasal solution via atomizer and a 50 cc     IV normal saline bag. Arm A would include 1 mg/kg intranasal ketamine and a 50 cc normal     saline IV bag while Arm B would receive placebo intranasal dose and 10 mg Metroclopramide/25     mg Diphenahydramine mixed in 50 ccs normal saline. The primary endpoints are: Patient     perception of pain as described by the use the Numerical Rating Scale (NRS) at 30 minutes.      The secondary endpoints are: Frequency and mean dose of rescue/additional doses of therapy at     30min, incidence of dissociative effects (characterized by hallucination, disorientation,     confusion, agitation, delirium, dreams) during study period, Incidence of nausea, vomiting,     or worsening headache, Incidence of bad taste, Incidence of burning sensations in the     nostrils, Incidence of hypertension, Time to patient discharge from the initiation of study     medication/placebo, patient satisfaction of pain control based on a Likert Scale.   "
4913|NCT03221556|"     This is a randomized comparative effectiveness trial to improve outcomes among pregnant and     post-partum women with symptoms of depression. Both interventions under study will be based     in the patient-centered medical home setting at Boston Medical Center - specifically, in     prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid     effectiveness-implementation trial of 230 mothers with clinically significant depressive     symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care     Coordination intervention; the other half will receive the Problem Solving Education     intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month     follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered     Outcomes Research Institute.   "
4914|NCT03221543|"     This study evaluates if measuring resting metabolic rate (the number of calories the body     burns at rest) before surgery can help predict successful weight loss after surgery.   "
4915|NCT03221530|"     The purpose of this project is to develop and test a family-based preventive intervention for     suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention     will focus on reducing suicide risk by reducing family conflict and intergenerational     cultural conflict and improving parent-child communication. The investigators will first     develop the 8-session preventive intervention with quantitative data from analysis of     existing longitudinal studies and qualitative feedback from Latino youth and their     caregivers, clinicians, administrators, and research consultants, as well as results from     initial pilot testing of the intervention. The investigators will then conduct a pilot     randomized trial with 40 adolescents and their families to test feasibility, acceptability,     and impact on intervention targets. Successful development of the intervention would improve     mental health outcomes for a growing and underserved portion of the U.S. population.   "
4916|NCT03221517|"     The investigators hypothesize that disruptions to the microbiome of shift-workers represent a     hitherto unexamined factor contributing to disease risk. The investigators will therefore     define time-of-day dependent fluctuations of the microbiome in night shift workers and     matched daytime workers deeply phenotyped for behavioral, clinical, and metabolomic outputs     using integrated remote sensing.   "
4917|NCT03221504|"     The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of     antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is     formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a     10-day course of therapy and would entail a lower risk of adverse events and better     compliance.   "
4918|NCT03221491|"     In this study, the investigators investigated the efficacy, usefulness and analgesic     consumption of three different patient-controlled analgesia(PCA) programmes:bolus dose alone     without background infusion, bolus dose with low background infusion and bolus dose with high     background infusion to evaluate postoperative analgesia for patients after laparoscopic     colorectal surgery.   "
4919|NCT03221478|"     Objective: The general objective of this study is to determine the possible beneficial effect     of the application of kinesiotaping, as well as the performance of proprioceptive exercises     on parameters related to knee stability, such as the incidence of injuries, pain, static     stability Or dynamics, and flexibility, in amateur soccer players, with a workload of 3 days     per week plus the match.      Material and methods: Amateur soccer players are divided into 3 groups.      Group 1 (G1) performs proprioceptive exercises plus the application of kinesiotaping without     tension in the knee.      Group 2 (G2) performs proprioceptive exercises plus the application of kinesiotaping with     tension in the knee.      Group 3 (G3) is placed kinesiotaping with tension in the knee, without proprioception     exercises.      The treatment will last four weeks and three evaluations, one before treatment, another at     two weeks and the last one at the end of treatment.   "
4920|NCT03221465|"     Project LIFT is a randomized, controlled trial that tests the effectiveness of a     remotely-monitored, home-based exercise program utilizing wearable fitness trackers to     monitor steps taken per day, health engagement questions, and financial incentives. 120     subjects will be randomized into 3 arms: 1) usual care - no fitness tracker or incentive, 2)     a fitness tracker + no incentives, and 3) fitness tracker plus financial incentives.   "
4921|NCT03221452|"     The aims of this project are: (1) to refine an existing cognitive rehabilitation intervention     and tailor it for persons with T2DM by using current literature and interview data from 10     participants with T2DM and (2) to conduct a feasibility study of the adapted intervention     with 20 participants with T2DM. The intervention consists of 8 weekly group educational     sessions to teach compensatory cognitive strategies. Participants will also use a web-based,     game-like program to build on the didactic information and practice activities to improve     cognitive health.   "
4923|NCT03221426|"     The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the     neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of adults with gastric     and gastroesophageal junction (GEJ) adenocarcinoma.      The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to     placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and     pathological complete response (pathCR) rate.   "
4924|NCT03221413|"     The need for non-invasive, non-pharmacological and cost-effective therapeutic options has     revived the use of transcranial current stimulation, either direct (tDCS) or alternating     (tACS), in a wide range of pathologies and cognitive disturbances. Results, although often     promising, are not unequivocal, possibly due to different stimulation parameters and sites,     or non-homogenous patient selection. tDCS has been widely applied but few studies have     focused on tACS which has the advantage of potentially entraining brain oscillations at the     same frequency of stimulation. This overcomes the basic mechanism of tDCS which deploys     anodal or cathodal currents to broadly excite or inhibit supposedly dysfunctional underlying     cortex.      Whether a stimulation paradigm based on sound neurophysiological markers could provide a     better and longer-lasting clinical outcome has not yet been ascertained.      The investigators aim to establish, with a trans-disease approach, categories characterized     by defective EEG oscillatory activity and related dysfunctional networks. This     classification, expected as the result of the first stage of this project, will guide the     stimulation paradigm: categories with a pathologically low-band EEG prevalence will be     treated with high-frequency tACS, and vice-versa, while the stimulation site will correspond     to the defective sites of pathological EEG band maps. Parkinson's disease (PD), the EEG     marker of which is a shift towards fast frequencies, and neuropathic pain (NP), with an EEG     prevalence of slow bands, will be considered.      In order to categorize pathologies on the basis of their EEG frequencies, EEG power spectrums     will be derived from resting EEG, and cortical oscillatory reactivity will be assessed by     EEG-TMS (electroencephalographic-Transcranial Magnetic Stimulation) co-registration. This     method appears to elicit state-dependent brain oscillatory response and is expected to     support power spectrum data. The identified prevailing EEG band will be used subsequently to     reconstruct scalp EEG band distribution. tACS paradigms will be tailored according to these     findings: the anode will be placed over the scalp area corresponding to the dysfunctional     rhythm and frequency will be set in order to correct the prevailing EEG band (slow     stimulation if fast frequencies prevail, and vice-versa).      The translational element of this research proposal will consist of its clinical application     in day-to-day practice for the benefit of people with the target conditions. The     patient-groups, after undergoing the neurophysiology studies, will be tested with     disease-specific scales and a neuropsychological battery. A 2-weeks tACS, either real or     active sham, protocol will then be performed (30 minutes/day, 5 days/week), associated with     an ad hoc rehabilitation protocol (60 minutes/day 5 days/week). During the last day of     stimulation, patients will be tested again with the disease specific scales,     neuropsychological battery and standard EEG to detect EEG frequencies modifications. At     4-weeks follow up, the same tests and EEG recording will be carried out, to assess the     persistence of after-effects.      The expected result is a valid, non-invasive and cost-effective stimulation paradigm based on     sound neurophysiologic markers which transcend traditional disease classifications.   "
4927|NCT03221374|"     Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices,     has become increasingly prevalent due to an increase in awareness of the potential health     benefits, and improvements in concentration that this training can provide to practitioners.     In the present study, the role of Mind-Body Awareness Training (MBAT) in the initial learning     of a sensorimotor (SMR) based Brain-Computer Interface (BCI) is being investigated. The     hypothesis is that MBAT will improve performance in SMR based BCI.   "
4928|NCT03221361|"     In this research we are comparing the new thermoplastic material side by side with the     conventional poly methyl methacrylate for fully edentulous patients measuring their maximum     biting force whether it is going to be higher by the new polyamide material.   "
4929|NCT03221348|"     This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and     anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in     subjects with follicular lymphoma.      Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be     evaluated to determine if it is appropriate to proceed with the additional 3 patients at that     dose and schedule.   "
4930|NCT03221335|"     Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung,     kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows     EUS-guided treatment of solid abdominal neoplasms. The procedure has been shown to be     feasible in the porcine pancreas and was used to treat small groups of patients that are not     suitable for surgery suffering from pancreatic cancers.      The aim of the current study is to perform a multi-center prospective study on EUS-guided     radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided     RFA is safe, feasible and effective for treating solid abdominal neoplasms.   "
4931|NCT03221322|"     Obesity is the 5th leading cause of global death, and is major risk factors for many chronic     diseases, such as type 2 diabetes, cardiovascular diseases, hypertension and cancer. Obesity     is caused by an imbalance between energy intake and energy expenditure, and it is widely     agreed to be a consequence of a gene by environment interaction. Although on average obesity     rates are increasing, the shape of the distribution of adiposity is changing: it is becoming     more right skewed. This is because there is a population of very lean subjects that has     remained almost unchanged by the epidemic. The investigators have called these very lean     individuals that are resistant to the epidemic and sustain a BMI < 18.5 kg/m2 'super lean'     subjects. We have very little understanding of the lifestyles of these individuals and how     they are able to maintain their super lean phenotype, and whether the basis of their leanness     is primarily genetics.   "
4960|NCT03220945|"     This randomized pilot trial studies the effect of comprehensive yoga program (SKY) in     reducing stress, pain, and fatigue, and improving psychological well-being in patients with     prostate cancer. SKY is one of the most widely used breathing techniques derived from yoga.     SKY Yoga may improve quality of life in patients with prostate cancer.   "
4932|NCT03221309|"     This is an open label, non-randomized, observational pilot study to evaluate a model of care     for treatment of hepatitis C in people with ongoing injection drug use. Participants will be     treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly     be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of     opioid use disorder when clinically indicated.   "
4933|NCT03221296|"     A feasibility study of a vestibular rehabilitation program in a sample of cognitively     impaired clinical patients to guide future trials.   "
4934|NCT03221283|"     The group music therapy will be used to treat female amphetamine-type stimulant (ATS)     addiction   "
4935|NCT03221270|"     Investigating the effects of non-invasive transcranial alternating current stimulation (tACS)     as a treatment for auditory hallucinations in patients with schizophrenia.   "
4936|NCT03221257|"     A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled     clinical trial addressing the treatment of patients with active and symptomatic     Scleroderma-related interstitial lung disease (SSc-ILD).   "
4937|NCT03221244|"     Problems with distraction are widespread in the 21st century, but for people with     developmental delays or behavioral challenges they can have more damaging effects. For     example, susceptibility to distraction is associated with worse school and social     performance, lower high school graduation rates, and increased incidence of serious     accidents. The investigators' goal is to improve understanding of distractibility and develop     a targeted treatment. The proposed intervention is based on models of habituation, which is a     term that means reduced physiological and emotional response to a stimulus (e.g. moving     object, or loud noise, etc.) as it is seen repeatedly. The investigators use virtual reality     technology to show study participants distracting stimuli repeatedly in a virtual classroom     setting, and their hypothesis states that participants will improve attention in the face of     distraction by training with this technology intervention. The virtual classroom setting is     especially relevant for children who have significant challenges with distractibility, such     as children with ADHD. This intervention will likely be effective in helping individuals with     other clinical disorders and perhaps the general population as well.   "
4938|NCT03221231|"     We investigate the effects of repeated NAC administration on glutamate concentrations in the     anterior cingulate cortex (ACC), on neurocognitive functioning, and on neuro-inflammatory     parameters in adult cannabis-dependent individuals.   "
4939|NCT03221218|"     The study will examine whether enhancing screening-informed follow-up letters will improve     (i) family physician compliance with best practice guidelines for managing persistent     symptoms following concussion, and (ii) clinical outcomes from concussion.   "
4940|NCT03221205|"     This study evaluates the effect of the use of nasal CPAP in the cardiac function, measured by     strain and TEI index, in patients with type 2 diabetes mellitus, obstructive sleep apnea and     obesity. In order to do so, 76 patients will be studied, half will use sham CPAP and half     will use therapeutic CPAP for three months, with ecocardiogram, laboratory studies,     ambulatory monitoring of arterial tension and sleep study before and after CPAP use.   "
5229|NCT03217422|"     Part 1 - To define the dose-response relationship of VAY736 for AIH patients with incomplete     response to or intolerance of standard therapy with respect to key efficacy and safety     parameters and to determine the most appropriate dose for Part 2 Part 2 - To confirm the     efficacy (biochemical and histological remission) and safety of the dose determined from Part     1 in this population.   "
4942|NCT03221179|"     The primary objective of this study is to evaluate the safety and tolerability of single     ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers. In     addition, pharmacokinetics (PK) of RO7049665, the effects of single doses of RO7049665 on     regulatory T-cells as well as the single dose immunogenicity of RO7049665 will be evaluated.     This trial plans to evaluate approximately seven single dose-levels of RO7049665 or     matching-placebo during dose-escalation in approximately 40 participants.   "
4943|NCT03221166|"     Crohn's disease (CD) is a life-long inflammatory bowel disease disease with an unknown     pathogenesis. The ultimate goal of therapy is to modify the natural history of CD thus     reducing complications. Thalidomide is a small molecule with immunomodulatory and     anti-angiogenetic properties. It is currently approved for the treatment of erythema nodosum     leprosum, an immunological complication of leprosy and multiple myeloma. It has also been     used in several other inflammatory diseases of the skin and of the mucosal membranes, such as     Behcet disease, oropharyngeal ulcers in AIDS, cutaneous lupus, and graft versus host disease.     Many case series and one pediatric randomized controlled trial proved the efficacy of     thalidomide in the treatment of children with CD refractory to standard treatments. In these     patients, clinical remission was achieved in about 50% of the cases and was maintained for a     mean time superior of 3 years. Mucosal healing after 52 weeks of treatment was observed in     40% of the patients in clinical remission. Moreover, thalidomide was found to have a     steroid-sparing effect and to decrease the need for surgical interventions. The clinical and     endoscopic efficacy of thalidomide was also observed in children with failure to respond or     intolerance to anti-TNF biological drugs.      The aim of this multicentric prospective randomized controlled is to evaluate the efficacy     and safety of thalidomide vs infliximab in changing the natural history of CD in patients     with poor prognostic outcome. Moreover, the study will evaluate the immunological and     genetical mechanisms of CD, the mechanisms of action thalidomide in CD and will the     pharmacokinetics, metabolomics and pharmacogenomics of thalidomide, and their impact on     thalidomide safety and effectiveness.   "
4945|NCT03221140|"     Outpatient parenteral antimicrobial therapy (OPAT) has been recognised as a useful,     cost-effective and safe alternative to inpatient treatment, but no formal OPAT unit existed     in Switzerland until recently. In December 2013 an OPAT unit was established at Lausanne     University Hospital. The investigators plan to investigate the efficacy, safety and     economicity of outpatient parenteral antimicrobial therapy administered at the new OPAT unit     of the Lausanne University Hospital starting in January 2014 until December 2020.   "
4946|NCT03221127|"     To determine associations between dietary factors and risk of major chronic diseases and     their risk factors   "
4947|NCT03221114|"     The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic     Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of     women have at least one major cardiovascular disease (CVD) risk factor. The American Heart     Association emphasizes that current CVD prevention efforts are sparse and ineffectual in     minority populations and acknowledges the need for new and more effective disease prevention     strategies. This observational study and pilot cluster-randomized clinical trial seeks to     implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an     attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e.,     elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for     clinically meaningful improvements in cardiovascular function.   "
4948|NCT03221101|"     Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute     hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown     to improve mortality and reduce intubation rate. Few studies are available about long term     benefits of home non invasive ventilation in COPD patients with chronic hypercapnic     respiratory failure who survived after an acute episode. The purpose of this study is to     determine whether home non invasive ventilation can reduce recurrent acute hypercapnic     respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure     episode treated by non invasive ventilation.   "
4949|NCT03221088|"     This study aims to explore the optimal dose of pegylated recombinant human growth hormone     (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its     safety and efficacy, and provide scientific and reliable evidence for the medication dosage     in Phase III clinical study.   "
4950|NCT03221075|"     In order to determine the efficacy of antifungal therapy in patients with documented     azole-resistant invasive Aspergillosis (IA), anonymized clinical information of patients with     a hematological malignancy with a culture-positive invasive fungal infection caused by     Aspergillus fumigatus are collected in an online registry. Respective fungal isolates are     analysed for azole susceptibility and resistance mechanisms. Patients diagnosed with an IA in     2016 and later are included in the study.   "
4951|NCT03221062|"     The traditional method of choice for intravesical resection of bladder tumors is conventional     transurethral resection of bladder tumor (cTURBT). However, there has long been an ambition     to overcome its biggest limitation, tumor fragmentation. Possible consequences include cell     seeding and poor specimen quality, including missing detrusor muscle, thermal tissue damage,     and tissue fragmentation. En bloc resection of bladder tumor (ERBT) represents an alternative     technique for resection of bladder tumors. There is no doubt that ERBT has huge potential.     ERBT provides specimens of high quality that are easy for pathologists to read. In theory,     this may sustainably change the view on secondary resection, lead to faster decisions on     subsequent treatments, and influence patient prognosis. Thus, there is an urgent need to     compare ERBT with cTURBT in a thoroughly planned trial.   "
4952|NCT03221049|"     Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly     concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease     progression. Hence,investors try to combine radiomics and ultrasound images together in order     to improve diagnosis performances of liver fibrosis, benign and malignant tumor and     progression after liver ablations.   "
4953|NCT03221036|"     The purpose of this study is to assess the effect of vedolizumab intravenous IV as induction     and maintenance treatment in Chinese participants with moderately to severely active     ulcerative colitis (UC).   "
5230|NCT03217409|"     A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with     Diabetes Mellitus and Hypercholesterolemia.   "
4954|NCT03221023|"     The implantable pulse generator (IPG) is a device that generates electrical current to     stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG     is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular     and thus, antibiotics administered intravenously cannot reach a potential surgical site     infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat     surgery and hospital re-admissions. We hope to to determine the effects of intrawound     vancomycin-saline and IV antibiotics compared to saline and IV antibiotics on the     incidence of IPG SSI rates 6-months post-surgery.   "
4955|NCT03221010|"     The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the     smoking cessation rates of the smoking groups performed by the primary care teams of the     Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in     the completion rate of the groups.   "
4956|NCT03220997|"     The primary aim of this randomised control trial is to assess the impact of pre-operative     carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care     in elective caesarean section. Half of the participants will receive pre-operative     carbohydrates and the other half will receive standard care.   "
4957|NCT03220984|"     This study aims to evaluate the safety and efficacy of Immuncell-LC, the adoptive     immuntherapeutic agent composed of a CIK cell agent, to treat patients with metastatic     colorectal cancer, which are refractory to the 3rd-line chemotherapeutic agents.      All enrolled patients received the 12 times of Immuncell-LC therapy: 8 times in every 1 week     and 4 times in every 2 weeks.   "
4958|NCT03220971|"     Theranostic translation applications against viral, metabolic liver diseases and hepatic     oncogenesis: lipoprotein and apolipoproteins at a crossroad   "
4959|NCT03220958|"     Nearly 1.5 million patients present to US emergency departments annually following head     trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study     is to see if an intravenous medication called metoclopramide can improve the symptoms of     patients with acute post-traumatic headache.   "
21406|NCT03005379|"     The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective     vs. placebo in the prevention of C. difficile infection recurrence.   "
4961|NCT03220932|"     With 4,600 new cases in France in 2012, ovarian cancer is the seventh most common cancer in     women and the fourth cause of mortality by cancer. Despite a high response rate to initial     treatment, most patients will relapse within 2 years. No standard treatment has yet been     established for patients with recurrent ovarian cancer.      Most patients with such recurrences are currently treated with new combinations of systemic     chemotherapy. A repeated laparotomy with complete cytoreduction is also an option that     several authors have used to obtain median survival rates of more than 30 months.      Twenty five percent of patients experiencing relapse present with platinum-resistant     recurrence, occurring less than 6 months after chemotherapy completion. Recently, Pujade et     al. showed that adding bevacizumab to chemotherapy significantly improves progression-free     survival (PFS) in this subgroup of patients with poor prognoses (16.6 months versus 13.3     months in women treated with chemotherapy alone). Three case control studies have compared     systemic chemotherapy and CRS (Cytoreduction Surgery) alone versus CRS plus HIPEC in patients     with recurrent disease. They showed significantly improved results with the addition of     HIPEC. In the French registry that included 474 patients with recurrence and peritoneal     carcinomatosis, the median PFS was 13.8 months for platinum-resistant patients and 13 months     for platinum-sensitive patients. Our hypothesis is that surgery would reduce the tumor burden     and consequently the number of platinum-resistant tumor clones and that HIPEC would control     the microscopic residual disease by increasing the tumor cell cytotoxicity.      We assume that adding a locoregional treatment to an Aurelia-like systemic treatment would     improve the PFS. We aim to assess the benefit of adding surgery and HIPEC to the treatment of     first or second platinum-resistant recurrence compared to chemotherapy + bevacizumab.   "
4962|NCT03220919|"     The investigators propose to use a weight-based regimen consisting of basal-bolus insulin and     preprandial rapid-acting insulin and to test its efficacy and safety in controlling blood     glucose in hospitalized patients with type 2 diabetes.   "
4963|NCT03220906|"     There is very little information comparing non-invasive blood pressure (BP) readings obtained     from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in     the children under anesthesia. This study seeks to determine the correlation between the     non-invasive BP measurements between upper and lower extremities and compare these     measurements with the invasive BP as the standard for comparison.   "
4964|NCT03220893|"     The significance of this study is that it will be the first prospective trial to compare MBI,     a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic     breast cancer screening technique in women with dense breasts. This study is also the first     to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation     after introduction of a functional imaging technique. These data will inform individualized     decisions on supplemental screening and determine if a functional technique that is     relatively low in cost and complexity of interpretation can eliminate the reservoir of     clinically important breast cancers that remain occult on anatomic techniques. This study     will also provide exploratory data about the optimal frequency of repeat MBI.   "
4965|NCT03220880|"     Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN     DEX in children undergoing non-painful procedures. This aim will test the working hypothesis     that IN DEX regimens are effective for producing sedation adequate for completion of     non-painful procedures in children.      Specific Aim 2: To describe the temporal characteristics associated with varied regimens of     IN DEX in children undergoing non-painful procedures, such as time to onset of adequate     sedation; time to procedure start; and time from procedure end to meeting discharge criteria.     This aim will test the working hypothesis that IN DEX regimens have temporal characteristics     that are favourable for sedating children for non-painful procedures.      Specific Aim 3: To describe the adverse events associated with varied regimens of IN DEX in     children undergoing non-painful procedures. This aim will test the working hypothesis that IN     DEX regimens have a low incidence of adverse events.   "
4966|NCT03220867|"     The primary purpose of this study is to assess the bioequivalence of Xian Risperdal compared     with Gurabo Risperdal in Chinese healthy participants under fasting and fed conditions.   "
4968|NCT03220841|"     Two thirds of patients with Crohn's disease require intestinal surgery at some time in their     life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring,     are the most common reason for surgery. Despite the high frequency, associated disability,     and cost there are no are no treatment strategies that aim to improve the outcome of this     disease complication. The STRIDENT (stricture definition and treatment) studies aim to     develop such strategies.   "
4969|NCT03220828|"     Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been     previously shown to increase the likelihood of family stressors, postoperative pain,     agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is     to determine if a non-invasive distracting devices (Virtual Reality headset, Augmented     Reality headset, tablet, or bed mounted Video Projection unit (i.e. BERT, Bedside     EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology     based distraction) for preventing anxiety before vascular access among hospitalized children     undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port     access, or peripheral IV placement. The anticipated primary outcome will be reduction of     child's anxiety during and after vascular access.   "
4970|NCT03220815|"     20 patients were selected requiring implant placement and divided randomly into two groups     (10 in each group)        -  for the study group, starter drill is used to locate the point of insertion as planned          then pilot drill is also used to the full desired working length after that all other          sequential drills are used at a low speed (50-70 rpm) without irrigation .        -  In the study group: implant will be inserted in the low speed osteotomy site. • In the          control group: implants will be inserted in the conventional prepared osteotomy site.        -  For both groups there is no surgical guide used.        -  The flap will then be copiously irrigated with saline in preparation for closure.        -  The flap will then be closed using interrupted 4/0 resorbable sutures.   "
4971|NCT03220802|"     Long-term proton pump inhibitor use has been linked to intestinal dysbiosis, inflammation and     gastrointestinal symptoms. Probiotics has been shown to correct dysbiosis, reduce     inflammation and strengthen the gut barrier. The aim of this study is to evaluate the     influence of a three months intervention with a probiotic on intestinal inflammation, bowel     symptoms, dysbiosis and gut permeability.   "
4985|NCT03220620|"     The objective of the study is to evaluate influence of perioperative fluid therapy on     Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be     related to metabolic signs of oxidative stress (changes in blood lactate). Patients     undergoing major abdominal surgery will be included into the study.   "
4972|NCT03220789|"     20 patients were selected requiring implant placement and divided randomly into two groups     (10 in each group)        -  for the study group, starter drill is used to locate the point of insertion as planned          then pilot drill is also used to the full desired working length after that all other          sequential drills are used at a low speed (50-70 rpm) without irrigation .        -  In the study group: implant will be inserted in the low speed osteotomy site.        -  In the control group: implants will be inserted in the conventional prepared osteotomy          site.        -  For both groups there is no surgical guide used.        -  The flap will then be copiously irrigated with saline in preparation for closure.        -  The flap will then be closed using interrupted 4/0 resorbable sutures.   "
4973|NCT03220776|"     The proposed 3-week, double-blind, crossover, proof of concept study aims to manipulate     neurochemical dysfunctions characteristic of individuals with co-occurring BD and AUD (i.e.,     abnormally low prefrontal GABA and glutamate), using medications that have been shown to     normalize cortical GABA (i.e., gabapentin) and glutamate (i.e., NAC) levels in past research,     and to evaluate medication-related changes in response inhibition and alcohol cue-reactivity     fMRI tasks as well as drinking and mood in individuals with AUD+BD.   "
4974|NCT03220763|"     The proposed study will test the hypothesis that frequency of eating away from home meals is     independently related to the prospective risk of mortality in the US population. The study     will use public-domain mortality linked data from US national Surveys to address this     question.   "
4975|NCT03220750|"     The University Hospital Advanced Age Pregnant (UNIHOPE) Cohort is the major part of the     National Key Research and Development Program on Reproductive Health & Major Birth Defects     Control and Prevention Project, which is funded by the Ministry of Science and Technology of     China. The Project is led by Prof. Zhao Yangyu, from the Department of Gynecology &     Obstetrics, Peking University Third Hospital, and the UNIHOPE cohort is led by Prof.     Jian-meng Liu, the Co-PI of the Project.   "
4976|NCT03220737|"     VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against     disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18     through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase     4 study is to evaluate the safety and immunogenicity of VAXCHORA in children ages 2 years to     <18 years of age in developed countries.   "
4977|NCT03220724|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of     EnvSeq-1 Envs adjuvanted with GLA-SE, administered with or without DNA Mosaic-Tre env, in     healthy, HIV-uninfected adults.   "
4978|NCT03220711|"     The overall aim of this research project is to evaluate the imaging performance of a confocal     endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide     topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic     histology to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient     study group. This endomicroscope probe will be used during colonoscopies in subjects with     colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or     suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).   "
4979|NCT03220698|"     The aim of this study is to compare tracheal ultrasound with direct visualization of tracheal     rings for the confirmation of endotracheal tube placement in intubated patients. We     hypothesize that this method is more reliable, cheap, and readily available for all emergency     physicians.   "
4999|NCT03220438|"     The major goal is to determine if Transcranial magnetic stimulation (TMS) enhances visual     plasticity in schizophrenia. TMS sessions (sham/placebo and real TMS) will be conducted     before two MRI scans with two weeks in-between to assess whether TMS stimulation to the     visual cortex will enhance visual plasticity in patients with schizophrenia-spectrum     disorders. This project may provide a better understanding of the underlying neurobiological     mechanisms responsible for learning and memory deficits in schizophrenia.   "
5000|NCT03220425|"     The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the     2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once     daily)-bolus regimen.   "
4980|NCT03220685|"     The human intestinal tract harbours a diverse and complex microbial community which plays a     central role in human health. It has been estimated that our gut contains in the range of     1000 bacterial species and 100-fold more genes than are found in the human genome . This     community is commonly referred to as our hidden metabolic 'organ' due to their immense impact     on human wellbeing, including host metabolism, physiology, nutrition and immune function. It     is now apparent that our gut microbiome coevolves with us and that changes to this population     can have major consequences, both beneficial and harmful, for human health. Indeed, it has     been suggested that disruption of the gut microbiota (or dysbiosis) can be significant with     respect to pathological intestinal conditions such as obesity and malnutritio, systematic     diseases such as diabetes and chronic inflammatory diseases such as inflammatory bowel     disease (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD) .      The role of the gut microbiome in human health and disease is becoming clearer thanks to high     throughput sequencing technologies (HTS) as well as parallel recent developments in non     genomic techniques.   "
4981|NCT03220672|"     The goal of the present study is to evaluate the short and long term effectiveness of a     tailored assessment and educational intervention on motor control of the pelvic floor muscle     in menopausal and non-menopausal women.   "
4982|NCT03220659|"     Recently, the introduction of quadripolar left ventricular leads (one with four pacing poles)     has allowed the opportunity to pace the lateral (back) of the heart from several points at     once using a single lead (multi-point pacing - MPP). Although it seems logical that     electrical beginning at several points on the left ventricular wall should improve     coordination of the heart, there is no consistent response in terms of improved remodeling     (cardiac structure and function) or composite scores of patient-related status. The     technology has a further disadvantage that it leads to accelerated battery drain, with on     average one year less longevity over the lifetime of the device.      Aims are:        1. to explore the effect of MPP on the force-frequency relationship,        2. to examine the effects of MPP on exercise capacity measured by treadmill walk time and          whether these are related to the FFR response to MPP in individual patients,        3. establish whether the acute contractile response is maintained to 6 months after the          implant procedure and        4. determine whether the acute contractile response to MPP is associated with subsequent          beneficial remodeling over a further six months.   "
4983|NCT03220646|"     The purpose of this study is to test any good and bad effects of a study drug called     abemaciclib (LY2835219) in patients with recurrent brain tumors.   "
4984|NCT03220633|"     A double-blind, placebo-controlled, phase I study to assess safety, tolerability and     pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy     male and female subjects.   "
4986|NCT03220607|"     To evaluate the performance of uterocervical angle (UCA) in the prediction of second     trimester terminations.   "
4987|NCT03220594|"     To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.   "
4988|NCT03220581|"     The fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)     introduces Internet Gaming disorder (IGD) as a Substance-Related and Addictive Disorder in     Section 3, Conditions for Further Study. Although research is in the nascent stages, existing     studies demonstrate that IGD is associated with psychosocial distress including suicidality,     and adverse vocational and educational outcomes in youth. Internet gaming disorder also     shares substantial overlap with substance use, and it primarily affects adolescents, who     rarely seek treatment on their own. Parents more often express concerns about their child's     game playing behaviors, and data suggest that parents can have strong influences on it. This     psychotherapy development study will evaluate feasibility, acceptability, and effect sizes of     a behavioral intervention designed to help parents reduce gaming problems in their children.     Sixty concerned parents and their children will complete parental and self-report inventories     and structured diagnostic interviews regarding the child's gaming behaviors, substance use     and psychosocial functioning. Participants will be randomized to either a control condition     consisting of referral for mental health issues and family support services or to the same     plus a 6-week family-based behavioral intervention designed to assist with better monitoring     and regulating the child's game playing behaviors and encouraging and rewarding alternatives     to game playing. Gaming and other problems will be assessed pre-treatment, mid-treatment, at     the end of treatment, and at a 4-month follow-up. This study is unique in evaluating initial     psychometric properties of a parental version of a measure that uses the DSM-5 criteria for     IGD in a clinical sample, and it will also assess associations of IGD with substance use,     psychological symptoms, and family functioning over time. Most importantly, this study will     be the first randomized trial of an intervention designed to reduce gambling problems, and     results are likely to guide future research and treatment efforts related to this condition.   "
4989|NCT03220568|"     Background: Although low-fat dairy products are an integral part of a diet recommended for     stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear.      Objective: Therefore the association of adipose tissue content of fatty acids, for which     dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2     cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated.      Design: The study is a case-cohort study nested within the Danish Diet, Cancer and Health     cohort, including all incident stroke cases and a random sample of the total cohort.The fatty     acid composition of adipose tissue biopsies was determined by gas chromatography and the     content of specific fatty acids was expressed as percentage of total fatty acids. Stroke     cases were identified in the Danish National Patient Registry and the diagnoses were     individually verified. Cox proportional hazard regression will be used to estimate the     association between fatty acids and stroke.   "
5001|NCT03220412|"     More American children die by accidental gun use than children in other developed countries.     One factor that can influence children's interest in guns is exposure to media containing     guns. The objective of this study is to test whether children who see a movie containing guns     will handle a real gun longer and will pull the trigger more times than children who see the     same movie without guns.   "
5002|NCT03220399|"     The purpose of this study is to compare the pharmacokinetics and safety/tolerability between     NVP-1603-1 and NVP-1603-2   "
5003|NCT03220386|"     The study EPICS-6 consists of three study phases. Emergency Department patients are screened     for nasal and pharyngeal colonisation with Methicillin sensitive and Methicillin resistant     Staphylococcus aureus (MSSA/MRSA) using a point-of-care (POC)-PCR-testing method     (cobas®LIAT®-System, Roche Molecular Systems Inc.) The first aim of this study is to describe     the prevalence of MSSA/MRSA-colonisation in a routine cohort of Emergency Department     patients. The second aim is to determine the impact of POC-guided decolonisation as compared     to conventional laboratory testing on in-hospital infection rates with MSSA/MRSA in a     pre-post-comparison study.   "
24196|NCT02968953|"     This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a     single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome.   "
4990|NCT03220555|"     In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in     pediatric patients. Prior painful experiences can reduce the acceptance of later health care,     hence making it more difficult for both patients and nurses.      The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction     and relaxation) interventions which are usually used for prevention of procedural pain impose     certain constraints on families and on vaccination centers.      A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could     overcome these constraints and could be an interesting alternative for healthcare management     in vaccination centers and, in a broader perspective, in other medical services.      Research on this device has been scarce to date. Three of them have shown an efficacy of     Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced     pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic     cream, but will be set in an emergency department context. To date, no study has compared     Buzzy® to topical anesthetic cream on healthy children in a vaccination center.      The research team has formulated the following hypothesis: the Buzzy® device will allow to     get a not lower or an equivalent level of pain compared to the level of pain obtained with     the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the     device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.   "
4991|NCT03220542|"     In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump     inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful     due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to     develop new treatment strategies that increase the eradication rate and reduce adverse     effects. In vitro study, we previously reported that a broccoli sprout extract containing     sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective     role in Hp-induced gastritis. Also, several studies suggested that probiotics could be     effective for improving Hp eradication rate or reducing adverse events. But, their effect for     eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate     the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for     eradication of Hp, compared with standard triple therapy.   "
4992|NCT03220529|"     The purpose of this research study is to find out if the new Brillouin Ocular Scanner can     measure the variation (difference) of the corneal elastic changes involved in the onset of     corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment.     Ectasia refers to the thinning and bulging of the cornea and results in severe vision     degradation (loss), which may occur because of a progressive disease (keratoconus) or because     of LASIK surgery. It is believed that the structural weakening of the cornea plays a major     role in developing ectasia. CXL is a treatment that is able to halt the progression of     ectasia.      The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed     measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of     the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound     waves are naturally present and they can induce a similar color shift. Measuring this color     shift with a sensitive light color meter (spectrometer), we will measure the sound speed in     the tissue.   "
4993|NCT03220516|"     The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three     types of scopes.   "
4994|NCT03220503|"     Research Question:      In women undergoing frozen embryo transfer, does routine endometrial injury before frozen     embryo transfer increase clinical pregnancy rate?      Research Hypothesis:      (Null Hypothesis) In women undergoing frozen embryo transfer Routine endometrial injury     before frozen embryo transfer does not increase clinical pregnancy rate.      (Alternative Hypothesis) In women undergoing frozen embryo transfer, endometrial injury     before the transfer may increase pregnancy rate.   "
4995|NCT03220490|"     According to the American Academy of Ophthalmology's Preferred Practice Pattern on Primary     Open Angle Glaucoma, patients should wait five minutes between administering topical drops     for intra-ocular pressure reduction.      To date, no study has shown the efficacy of this waiting period. In this study, we aim to     establish the clinical significance of keeping a time interval between glaucoma medications.   "
4996|NCT03220477|"     The purpose of this study is to test the safety of a combination of three drugs,     pembrolizumab, guadecitabine and mocetinostat. Pembrolizumab is a drug given by vein and all     patients will receive the same dose. Guadecitabine and mocetinostat will be given at     different doses to find out what effects, if any, they have on treating your cancer and side     effects.   "
4997|NCT03220464|"     The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for     early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary     tuberculosis for 1 year follow up   "
4998|NCT03220451|"     All patients with a significant deficiency of skin sensitivity and reduced mobility are     potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal     Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin     sensitivity. Pressure sores are one of the most common and fearful complications in SCI, with     a severe impact on quality of life and on care health costs. They are often the cause of     lengthening the time of hospitalization, slowing down clinical and rehabilitation programs     and re-hospitalization.      PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies,     sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although     even after it recurrence rates remain high.      Further treatments have been proposed in addition to the usual medication, however they are     characterized by a certain degree of invasiveness and are often conditioned by the     availability of specific and sometimes expensive equipment, as well as by the presence of     highly qualified personnel. In general, there is also a lack of good quality clinical trials     for assessing their effectiveness and safety and they are often not decisive, especially for     severe and recalcitrant ulcers.      Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic     bandage, also known as kinesio taping and already recognized for the treatment of edema,     hematoma and scarring, has been proposed. However, specific protocols and published studies     are not available for PUs.      The Montecatone Rehabilitation Institute, that hosts the largest Spinal Unit in Italy, pays     great attention to the prevention and treatment of PUs in both acute and chronic patients.     The rationale for the taping positioning around PUs investigated in this study is to improve     lymphatic drainage and reactivation of the superficial bloodstream by increasing interstitial     spaces and reducing skin and subcutaneous compression, notoriously compromised in the areas     of onset of pressure sores. The total shortage in the literature and in user manuals of     taping protocols for PUs supports this preliminary, exploratory, descriptive and uncontrolled     pilot study with the primary aim of verifying the safety of a taping treatment for     medium/severe grade PUs, add-on to the usual care. The choice of the ulcer sites selected     (sacral and heel) has been affected by the feasibility of tape positioning.   "
5251|NCT03217136|"     This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)     plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.   "
5006|NCT03220347|"     Study CC-90010-ST-001 is an open-label, Phase 1a, dose escalation and expansion,     First-in-human (FIH) clinical study of CC-90010 in subjects with advanced or unresectable     solid tumors and relapsed and/or refractory advanced Non-Hodgkin's lymphoma (NHL). The dose     escalation part (Part A) of the study will explore escalating oral doses of CC-90010 to     estimate the maximum tolerated dose (MTD) of CC-90010. The expansion part (Part B) will     further evaluate the safety and efficacy of CC-90010 administered at or below the MTD in     selected expansion cohorts of approximately 20 evaluable subjects each in order to further     define the recommended Phase 2 (RP2D) dose of CC-90010.   "
5007|NCT03220334|"     In Korea, where the prevalence of gastric tumors is high, the use of ESD as a treatment for     gastric cancer will continue to increase. Considering that there are no special measures to     prevent side effects (bleeding, perforation, etc.) of this procedure, it is possible to     reduce the large medical costs through the discovery of substances that can promote gastric     mucosal healing. Mechanism of PRP-based materials in the regeneration of gastric mucosal     damage can be used to understand the pathophysiology of ulcers. In the future, it can be     suggested as a new treatment for gastrointestinal tract damage such as intractable ulcer,     perforation, mucosal fistula, gastrointestinal bleeding caused by esophagus, small intestine     and large intestine as well as ulcer treatment by endoscopic procedure.   "
5008|NCT03220321|"     The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid     ceramic on pink and white esthetics in comparison with lithium disilicate.      The research hypothesis is that there will be comparable clinical performance results between     polymer-infiltrated-ceramic-network and lithium disilicate hybrid abutment crowns.   "
5009|NCT03220308|"     This study evaluates the effectiveness of an 8-week mindfulness group training for children     (8-16 years old) with ADHD in combination with a parallel mindful parenting training for     their parents. Half of the participants will be randomly assigned to the mindfulness training     in addition to care-as-usual (CAU); the other half to CAU-only.      The hypothesis is that compared to care-as-usual only, the addition of the mindfulness     training will improve self-control of youth with ADHD.   "
5011|NCT03220282|"     Late preterm infants, who are born at 34, 35 or 36 weeks gestation, often have difficulty     feeding, establishing growth, and fighting off infection. Breastfeeding provides improved     nutrition to help fight infection, in part because breast milk encourages the growth of     healthy bacteria (microbiota) in the infant's intestine. However, when mothers give birth     preterm, their breasts are usually not quite ready to make milk; it can take several days to     have enough breast milk to match a baby's nutritional needs. If there is not yet enough     breast milk, formula is often used. However, formula can interfere with the growth of healthy     intestinal bacteria. An alternate nutritional option is donor milk from a certified milk     bank, which is available in all neonatal intensive care units (NICUs) in San Francisco.     However, no scientific studies have yet studied donor milk for late preterm infants, so     currently all San Francisco NICUs (as well as the large majority of NICUs nationwide) reserve     donor milk for infants born at <34 weeks. This study's investigators therefore propose the     Milk, Growth and Microbiota (MGM) Study, a randomized controlled trial to compare banked     donor milk to formula for breastfeeding late preterm infants born in San Francisco. Once     enrolled in MGM, infants will be randomly assigned to receive either formula or banked donor     milk if they need additional nutrition until their mothers are making enough milk. After     enrolling the babies, investigators will weigh them daily to assess their growth. The     investigators will also collect infant bowel movements at baseline, 1 week and 1 month to     determine whether donor milk vs. formula impacts the type of bacteria in the baby's     intestine. If the study's results show that donor milk optimizes growth while helping     establish healthy bacteria in the baby's intestine, donor milk might be postnatal strategy to     bolster neonatal nutrition for late preterm infants.   "
5012|NCT03220269|"     RIAC - An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and     Outcome of Cardiac Arrest in Italy.   "
5013|NCT03220256|"     The investigators intend to find a way to lower drug rash occurrence by applying drug     tolerance induction protocol at the beginning of lamotrigine administration.      Genotyping of participants with rash and those without rash after taking lamotrigine and     genetic testing to find common gene mutations in these participants.   "
5014|NCT03220243|"     The purpose of this study is to determine the safety of using an autologous mesenchymal     stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's     disease. This is an autologous product derived from the patient and used only for the same     patient. Participants will be in this study for two years. There is potential to continue to     monitor participants' progress with regular visits as part of standard of care. All study     visits take place at Mayo Clinic and Rochester, MN.      The study visit schedule is as follows:      Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility     of fistula tract, take fat biopsy, if eligible, and fecal diversion.      Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement     Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8;     Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12).     Visit 10 (Week 104, Month 24)   "
5015|NCT03220230|"     This is a non-interventional multi-center with investigational sites in Chile and Brasil     diagnostic study to validate novel diagnostic technologies, such as Next Generation     Sequencing (NGS) from both tissue and blood compared to the current gold standard. As a     non-interventional study, patients will receive the treatment indicated by their doctor     independently of their participation on this study.      Many cancer cells look the same under the microscope. But as these cells are studied at the     molecular level, some genetic alterations or defects that are more common to certain types of     cancer are identified. In some cases, these defects are what make the cells grow and multiply     abnormally.      Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of     your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and     that may point to a specific treatment choice.      One of the genetic biomarkers that are believed to cause some cancers to grow is the ALK     fusion gene. About 3% to 5% of people with NSCLC may test positive for ALK. ROS1 is a     receptor found in 1 to 2% of people with this type of cancer.      The present study is designed to advance the molecular testing methodologies to identify ALK+     and ROS1+ NSCLC patients.      A positive correlation with these new technologies will mean an efficient, more accurate     diagnostic test, which could impact a greater number of cancer patients around world.   "
5016|NCT03220217|"     The purpose of this clinical research is to define the optimal dose of 68Ga-OPS202 as a PET     imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine     tumors (GEP-NETs). 68Ga-OPS202 is a radiolabelled imaging agent to be used in association     with Positron-Emission-Tomography (PET). 68Ga-OPS202 is made of two main components: 1)     OPS202, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type     2) present on the surface of the tumor cells and 2) Gallium 68, a radioisotope that combined     with OPS202 can be seen in the PET scanner.   "
5019|NCT03220178|"     In this study the investigators assess the impact of the eHealth-supported therapy management     system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic     breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in     combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be     combined with biomarker screening to identify predictive markers for and to learn more about     adherence, symptoms, response, and resistance.   "
5020|NCT03220165|"     The purpose of this study is determine in healthy males how MGL-3196 is metabolized using a     radio-labeled version of MGL-3196.   "
5037|NCT03219944|"     Soft tissue biotype is a critical factor for success of implant in the esthetic zone .     Different soft tissue augmentation techniques have been employed to increase soft tissue     thickness such as: autogenous grafts, allografts, xenografts and living cellular construct     (LCC). Studies showed that, allografts and xenografts were inferior when compared with     autogenous graft . However, few studies were conducted to evaluate the efficacy of soft     tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with     SCTG.   "
5038|NCT03219931|"     Infant colics represent a clinical condition in childhood, characterized by an uncontrollable     crying that occurs without any apparent organic cause.1 They can be associated with face     redness, closed fists, thighs flexion, meteorism, and gas emission. They are generally     diagnosed according to Wessel's rule of three (>3 h of crying a day, for >3d a week, for     >3wk in a row).2 These crises tend to reach their maximum intensity at 6 weeks of age, in     most cases.3 They represent a serious source of anxiety for the family, increasing hospital     admissions (5.8% of infants),4 postpartum depression risk, with higher stress levels for up     to 3 years from these events. The etiology is still unknown. Anyway, it's assumed that the     following factors may be involved: (1) Lactose intolerance. (2) Food hypersensitivity. (3)     Feeding difficulties. (4) Disorders of the enteric nervous system. (5) Alterations of pain     transmission. (6) Gastroesophageal reflux. (7) Intestinal hormones. (8) Psychosocial factors.     (9) Alteration of the intestinal microbiota. In 1994, Lehtonen was the first to suggest that     an altered intestinal microbiota composition in the very first months may induce intestinal     colics in infants. Human intestinal microbiota is composed of about 1013 to 1014     microorganisms, mainly bacteria. The total number of microbiota genes is called microbioma     and it is estimated to be 150 times the number of genes in the human genome.5 It acts as a     real organ, whose activity can be influenced by diet, lifestyle, prebiotics, probiotics, and     antibiotics. Several studies revealed the predominance of bifidobacteria in breastfed     infants, whereas bottle-fed infants show a mixed population where bifidobacteria are less     represented. the intestinal microbiota composition in a 3-year-old child is already similar     to that of an adult.6 Other factors conditioning the microbiota are gestational age and type     of birth. Colicky infants have a microbiota with a slow development and a lower stability     over time.7 It also contains less lactobacilli and bifidobacteria, and a prevalence of     gram-negative bacteria. The stools of these children often show increased levels of     calprotectin, an intestinal index of inflammation.      RISK FACTORS ARE SEVERAL: Smoking: The exposure to cigarette smoke may be related to colics;     this might be connected to the increase of plasma and intestinal levels of motilin. Maternal     smoking during pregnancy seems to increase the risk of developing colics, more than postnatal     exposition to smoke.8      Psychosocial: Infant colics may be more frequent with an instable psychosocial family     environment. Maternal stress, anxiety, and depression are important risk factors.8     Breastfeeding: The difference between breastfeeding and bottlefeeding for colicky infants is     controversial. Many studies have shown contrasting results,17 but the majority of the authors     agree to attribute an important role to bottlefeeding. 9 A melatonin role was assumed too.     This hormone is not secreted in infants, but only in adults, and has a hypnotic and relaxing     role on the gastrointestinal smooth muscle. Its concentration shows a clear circadian rhythm,     with a pick during night hours. Its presence in breast milk may be related to the lower     occurrence of colics in breastfed infants compared with the bottle-fed infants.9 Recent     literature shows an increasing attention toward probiotics,10 for the intestinal microbiota     modulation. Some Lactobacillus reuteri strains were studied, with contrasting results in     different studies; other probiotics as bifidobacteria showed in vitro anti-inflammatory     properties and the ability to inhibit coliforms growth, whose presence is significant in     colicky infants. Some probiotics exert a direct action on the bacterial growth, through     bacteriocins production and final fermentation products.11 Bifidobacterium breve was isolated     from healthy infants' feces.12 Aloisio et al13 tested in vitro ability of this strain and of     other 45 bifidobacteria strains to oppose the growth of several microorganisms such as E.     coli, S. enteriditis, C. difficile, K. pneumoniae, and Enterobacter cloacae. B. breve BR03,     in a randomized clinical study, proved to have a beneficial effect on constipation in adults,     it also seemed effective for the reduction of gas formation and for abdominal distension, and     no side effects were shown during the treatment, while the beneficial effects lasted for up     to 15 days after the end of the treatment.14,15 Both bifidobacteria strains showed, during an     in vitro study, the ability to oppose 4 strains of E. coli; in particular, BR03 displayed an     activity against E. coli O157:H7, an enterohemorrhagic strain that through Shiga toxin causes     a potentially lethal infection.16   "
5039|NCT03219918|"     The study is designed to examine whether colonoscopy using an EndoRings cap has a higher     adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare     completion rate, completion time, complication rate and detection of malignancies. Half of     the patients will be randomised to colonoscopy using cap and the other half to no cap.   "
5021|NCT03220152|"     Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining     the informed consent and confirmation of eligibility within 45 days after the screening     visit.      Once included, participants will be examined in a follow-up visit performed four weeks later     and evaluated for evidence of seroconversion to HIV, medication compliance and clinical     toxicity. The second follow-up visit will occur at 12th week and every 12 weeks successively     (quarterly). Quarterly visits include HIV testing, serum creatinine and counseling on     medication compliance and risk reduction.      The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the     PK study. In all visits will be assessed the risks, HIV testing will be performed, monitoring     of renal function and dispensing of the drug Truvada [emtricitabine 1 tablet (FTC) /     tenofovir (TDF) (200/300 mg) once a day orally for 12 months].      Participants who have completed 48 weeks of follow-up or prematurely discontinue a PrEP will     be encouraged to return for a follow-up visit after discontinuation of medication for     monitoring of the status and evaluation of HIV as the resolution of side effects.   "
5022|NCT03220139|"     Background Cancer and cardiovascular diseases combined account for more than 50% of the     overall mortality burden in the USA. Accumulating evidence indicates that saturated fat     intake is related to an increase, while unsaturated fat intake is related to a decrease in     all-causes mortality. Thus, current US dietary guidelines recommend a shift from saturated to     unsaturated fat.      Objective The aim of the present study was to estimate the mortality risk reduction related     to a dietary change from saturated fat to an equal amount of mono or polyunsaturated fat     intake.      Design The American National health and nutrition examination surveys conducted between 1999     and 2010 were linked to the 2011 national US death registry resulting in an observational     prospective mortality study. Proportional hazards Cox models were used to evaluate the     association between saturated, mono-unsaturated and poly-unsaturated fat with all-cause, and     cause specific mortality. Substitution analysis was conducted to estimate an iso-caloric     substitution of 10% of the energy from dietary fat intake applied to the substitution of     saturated fat with an equal amount of energy from mono-unsaturated or poly-unsaturated fat.   "
5023|NCT03220126|"     The purpose of this study is to look at the amount of the study drug, LY3074828, that gets     into the blood stream and how long it takes the body to get rid of LY3074828 when given     together with LY9999QS compared to LY3074828 alone. The tolerability of the different     formulations will also be evaluated and information about any side effects experienced will     be collected.      Screening is required within 28 days prior to the start of the study. For each participant     the total duration of the clinical trial will be approximately 13 weeks, not including     screening.   "
5024|NCT03220113|"     The purpose of the study is assessment of the safety and efficacy of the De-Novo therapy in     the treatment of craniofacial neuralgia and migraine headaches.This is an open-label study of     simultaneous administration of combination of dexamethasone, lidocaine, and thiamine into the     trigeminal nerve branches as well as greater and lesser occipital nerve bilaterally in one     session.      Patients who meet the exclusion and inclusion criteria are eligible for trial if they have     experienced chronic migraine and craniofacial pain not responding to other prior therapies.   "
5025|NCT03220100|"     This research study is evaluating a new way to provide palliative care to patients who have     recently been diagnosed with lung cancer. . Palliative care is a medical specialty focused on     lessening (or palliating) patients' symptoms and helping patients and their families cope     with a serious illness.   "
5026|NCT03220087|"     The objective of this study is to describe the use of resources and the costs associated with     controlled or uncontrolled CS in patients with NETs in Spain.   "
5028|NCT03220061|"     Effectiveness of music therapy on blood pressure and anxiety among patients undergoing     haemodialysis   "
5029|NCT03220048|"     Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated     nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.   "
5030|NCT03220035|"     This phase II trial studies how well vemurafenib works in treating patients with solid     tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have     spread to other places in the body and have come back or do not respond to treatment.     Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
5067|NCT03219541|"     The purpose of this study is to develop and then test the feasibility, acceptability, and     preliminary effect of a bidirectional text message smoking cessation intervention among     Vietnamese smokers in Hanoi, Vietnam. The specific aim are: 1) To develop a smoking cessation     text message library among Vietnamese smokers; 2) To evaluate message preferences, and the     feasibility and acceptability of the bidirectional text message smoking cessation     intervention; and 3) To assess the preliminary effect of a bidirectional mobile phone text     message intervention on biochemically validated smoking abstinence.   "
5031|NCT03220022|"     This phase I trial studies the side effect and best dose of ibrutinib in combination with     rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin     hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage     II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in     chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and     doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and     doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse     large B-cell lymphomas.   "
5032|NCT03220009|"     This randomized phase II trial studies how well nivolumab or expectant observation following     ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma     that is restricted to the site of origin without evidence of spread, has spread to a local     and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and     ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the     mucosal melanoma may not need more treatment until it progresses. In this case, observation     may be sufficient. It is not known if nivolumab or expectant observation following     ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.   "
5033|NCT03219996|"     The investigators performed a retrospective, single-center observational study, and the     participants with acute fulminant myocarditis were included.Then, the investigator analyzed     the risk factors of in-hospital death in these participants with acute fulminant myocarditis.   "
5040|NCT03219905|"     Kinesio-taping (KT) has recently gained so much popularity and a growing number of physicians     started using it to alleviate musculoskeletal symptoms. It was originally developed by Kenzo     Kase in 1976. The effects of KT on ankle proprioception and stability have been investigated     in previous studies. However, these studies are limited and the current data is conflicting.     Repeated application of KT in a patient with chronic ankle instability has been shown to be     effective in improving balance. In basketball players with chronic ankle sprain, KT did not     improve or inhibit balance. Application of KT did not cause a significant change in balance     of healthy subjects. The aim of this study was to evaluate the immediate and short-term     effects of KT on balance of healthy subjects.   "
5041|NCT03219892|"     This study is a double blind comparative study examining the effectiveness of the rTMS     treatment on Freezing of Gait (FOG) in patients with Parkinson's disease (PD). The     investigators hypothesize that treatment with rTMS on supplemental motor area will improve     gait quality and decrease the frequency of FOG in PD patients.   "
5042|NCT03219879|"     This study determines the effectiveness of telephone-delivered cognitive-behavioral     continuation therapy (T-CT) in comparison to usual care in people with recurrent or chronic     depression. The primary research question is whether participating in T-CT reduces depressive     relapses. The continuation therapy comprises eight therapy sessions delivered over the     telephone by a trained therapist over a period of approximately six months following     acute-phase psychotherapy.   "
5043|NCT03219866|"     This will be a non-blinded feasibility (pilot) study comparing triple therapy nebulizer vs     dry powdered inhalers (DPI) for care transitions in COPD exacerbation patients.      We hypothesize that patients treated in hospital and discharged on respiratory medications     administered by nebulizers will exhibit better quality of life (QoL), symptom control, and     lower COPD and all cause hospital readmission rates compared with patients treated with     respiratory medications delivered by DPI.      We aim to demonstrate that:        1. Patients treated and discharged on nebulized bronchodilators will have fewer          readmissions to hospital at 30 and 90 days compared to the group utilizing DPI        2. The nebulizer group will demonstrate a longer duration of time until hospital          readmission for COPD and all cause readmission compared to the group utilizing DPI        3. The nebulizer group will demonstrate better QoL (measured by the SGRQ - Saint George          Respiratory Questionnaire) and symptom control (as measured by the CAT & mMRC) compared          to the group utilizing DPI.   "
5044|NCT03219853|"     Study aims to investigate 2 topics:        1. Flavour-Nutrient Learning (FNL) FNL proposes that personal food preferences may be          influenced by unconscious mechanisms which operate to ensure the safeguarding of          individual nutrient levels. The theory postulates that food preferences may change over          time to address changing nutritional status (Yeomans, 2012).           This study aims to explore FNL in humans by investigating the preferences of          participants with low and high blood-selenium levels in relation to selenium-enriched          parsnips. Participants will be investigated in a two-week trial in which they will          undertake two food sensory tests: one before, and one after, the two-week period where          they will incorporate provided parsnips into their diet.           Some provided parsnips will contain higher levels of selenium than others, neither the          participants nor the lead researcher will know which type of parsnip each participant          receives.           It is hypothesised that the second food sensory test, performed after the intervention          period, will show that participants of lower initial blood-selenium levels will          demonstrate an increased liking for the selenium-enriched parsnips. This may demonstrate          possible FNL in humans.        2. Relationship between selenium intake & plasma selenium-status. This study will also          examine the relationship (if any) between the selenium intake of all participants via          the different types of parsnips, and their individual blood-selenium levels.      This will be assessed via blood tests before, during and after the trial in order to observe     the blood-selenium levels of each participant.      It is hypothesised that the blood-selenium levels of participants of lower initial selenium     readings will be the most improved upon consumption of selenium-enriched parsnips.   "
5045|NCT03219840|"     This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and     gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical     oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School     of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum     in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum     in the second treatment period (21 days). The other half will be assigned to follow the same     schedule but with the treatment reversed. A statistician will perform the randomization.     Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival     Index (GI), and percent of bleeding sites on probe (BOP).   "
5068|NCT03219528|"     Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly     understood condition with limited treatment options. Current therapies, including a     nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides,     disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of     patients. In this proposal, we will randomize IBS-D patients to receive either rifaximin or     low FODMAP dietary intervention.   "
5046|NCT03219827|"     Severity of allergic reactions are highly variable from one individual to another, they can     range from absent to life threatening. Allergic manifestations and specifically those of     anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells     and/or basophils followed by the release of histamine. Recently however evidence accumulated     that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while     the variance in human populations is an important subject to scientific research, medical     practices and public health policies typically take a 'one for all' approach to disease     management and drug development. Indeed, individual heterogeneity in the immune response can     have a big impact on the likelihood to respond to therapy. Because of the complexity of     immune responses in the individual and within the population, it has not been possible thus     far to define the parameters (genetic or environmental) that define the immune system of     allergic patients and its natural occurring variability. Thanks to the efforts that have been     made in the framework of the Labex Milieu Intérieur study genetic, immunological and     environmental factors have been identified that can be linked to the heterogeneity of immune     responses in healthy individuals. By comparing these already available data from healthy     individuals to a novel cohort of patients with defined severe allergic manifestations, we     will be able to identify for the first time immunological and environmental parameters that     are common to patients with severe allergies and identify those parameters that distinguish     allergic patients from the healthy donor cohort. This analysis will thus open new     perspectives on deregulated immune pathways in allergic patients allowing to orient future     treatment approaches. Furthermore, comparing immune responses before and after     allergen-specific immunotherapy will help understanding, which changes in immune responses     are causal to a successful treatment. Importantly, this analysis will shed light on the     individual differences that may predict the outcome of treatment approaches and propose novel     markers of its success.   "
5047|NCT03219814|"     The purpose of this study is to assess a cognitive dissonance-based eating disorder     prevention intervention program on its ability to reduce attentional biases in     body-dissatisfied women.   "
5048|NCT03219801|"     This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal     stem cells transplantation in systemic lupus erythematosus.   "
5049|NCT03219788|"     The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014     all over the world. Obesity results in anatomical, physiological and pharmacological changes     which represent a challenge for every anesthetist. Difficult airway increases by 30% with     obesity and so awake extubation are the preferred technique. Coughing can be alleviated by     opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an     ultra-short acting opioid and its effect swiftly and predictably disappears after cessation.     An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI),     and the expected effective effect-site concentrations investigated have ranged from 1.5 to     2.5 ng.ml/L.   "
5050|NCT03219775|"     TITAN-TCC (0416-ASG) is a Phase 2, open-label study of nivolumab (BMS-936558) monotherapy     with additional nivolumab/ipilimumab boost cycles in previously untreated and     platinum-based pretreated, 2nd and 3rd line, advanced or metastatic transitional cell     carcinoma subjects. Nivolumab is a fully human PD-1 antibody which blocks the respective     immune checkpoint in a ligand (PD-L1/PD-L2) independent manner.   "
5051|NCT03219762|"     Evaluate the activity and safety of Nab-paclitaxel in patients with sensitive or refractory     SCLC who relapsed after cisplatin or carboplatin and etoposide first-line chemotherapy.   "
5052|NCT03219749|"     Obstructive sleep apnea (OSA) results in vascular dysfunction, which increases the risk of     cardiovascular disease. In contrast, exercise confers cardioprotection through improvements     in vascular health. This proposal evaluates whether the beneficial effects of exercise on     vascular function are attenuated in obese individuals suffering from untreated OSA.   "
5053|NCT03219736|"     Study Summary:      Title: A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric     Emergency Department for the Treatment of Acute Asthma Exacerbations      Principal Investigator: Thomas J. Abramo, MD      Hypothesis: For acute moderate to severe pediatric asthma exacerbations the use of     NIPPV/BiPAP, in conjunction with current standard of care therapies, will lead to a more     rapid improvement in patient ventilation, faster resolution of respiratory distress and     result in improved ventilatory parameters, secondary outcomes and pediatric asthma scores.      Study Design: Prospective, randomized controlled trial      Study Duration: This study will be conducted over a 36 month period.      Sample Size: 240 subjects      Population: Children ages 2-17 years of age presenting to the ED with Acute asthma     exacerbation and a Pediatric Asthma Score (PAS) ≥ 8.      Synopsis: Eligible subjects will be randomized to either a control group or study groups. The     study groups will be either a NIPPV/BiPAP group. The subjects in the study groups will     continue to receive all standard of care therapies per the asthma severity protocols. All     nebulized therapies will be given through the NIPPV circuit. Patients will be assessed by the     pediatric asthma score (PAS), measured respiratory parameters, volumetric end tidal carbon     dioxide monitoring and measured cardiac parameters.      Objectives: A. Evaluate if the use of NIPPV/BiPAP in conjunction with traditional inhaled     beta-agonists improves the outcome in pediatric patients with acute moderate to severe asthma     in the acute setting.      B. Describe the physiology of NIPPV/BiPAP by measuring cardiac parameters in children     randomized to a NIPPV group.      C. Monitor safety of NIPPV/BiPAP use for acute asthma exacerbations in children.      Safety A.: The study must be IRB approved.      B.: Appropriate consent and assent documents will be obtained prior to enrolling the subject     in the study.      C.: A clear safety plan including DSMB will be established to monitor for adverse events.      D.: Confidentiality will be ensured for all subjects enrolled in the study.   "
5054|NCT03219723|"     The purpose of this study is to evaluate the safety and efficacy on patients receiving     first-line eradication and second-line eradication including vonoprazan (Takecab) tablets     (triple therapy) in the routine clinical setting.   "
5055|NCT03219710|"     Chemotherapy induced nausea and vomiting (CINV) is one of the most distressing toxicities of     cancer treatment. It can occur up to 90% in case of highly emetogenic chemotherapy (HEC) use.     It is important to effectively manage CINV for a number of reasons. Acute phase vomiting can     lead to vomiting in the delayed phase. It causes poor compliance with further therapy.     Quality of life is compromised. It is easier to prevent nausea/vomiting than to treat it.     Though strategies for prevention of CINV have been improved, it is still a significant     problem. Newer drugs were explored and studied. The complete response rates were further     increased with usage of olanzapine, an FDA approved antipsychotic, which blocks multiple     neurotransmitters in the central nervous system.      Olanzapine has been studied in multiple randomized trials in adults for its safety and     efficacy in prevention of CINV. Various RCTs have demonstrated the superiority of olanzapine     for prevention of CINV in patients receiving highly and moderately emetogenic chemotherapy.     Olanzapine has been approved for prevention of CINV in adults.      Unfortunately there are no large randomized trials demonstrating the efficacy of olanzapine     for CINV prevention in children receiving HEC. The positive experience with olanzapine     reported in adult oncology patients has prompted some pediatric clinicians to prescribe     olanzapine for individual children receiving chemotherapy. Olanzapine is frequently used for     the treatment of schizophrenia and bipolar disorder in children and adolescents. Though     various studies have demonstrated safety of olanzapine in children, data regarding the     efficacy of olanzapine in children and adolescents for prevention of CINV is limited. There     are many small studies describing the safety and efficacy of olanzapine for prevention of     CINV. However, there are no large randomized trials. Olanzapine is available in generic form     and is not an expensive drug. Therefore we would like to conduct a randomized trial to look     for the efficacy of olanzapine in pediatric population for prevention of CINV   "
5069|NCT03219515|"     This is a prospective, multicenter, randomized, double-blinded, placebo-controlled,     parallel-group, clinical trial to explore the effectiveness of an herbal medication,     Gongjin-dan (GJD) for chronic dizziness (Ménière disease, psychogenic dizziness, or dizziness     of unknown cause), identified as liver-deficiency pattern/syndrome, and assessed with     Dizziness Handicap Inventory (DHI) ≥ 24 at baseline. Participants will be randomized and     allocated to either GJD or placebo group with 1:1 ratio and orally administered GJD or     placebo pills once a day for 8 weeks. For collecting data for cost-effectiveness analysis,     the participants will be followed up to 12 months from randomization.   "
5056|NCT03219697|"     This study will determine whether a primary care based intervention that combines group based     parenting skills training and public health nurse home visits with a focus on healthy     nutrition, activity and sleep, compared to regular health care will lead to improved weight     status in 18 months-3 year old children.      Healthy children at risk for obesity will be identified through primary care practices     participating in TARGet Kids!. Families who participate in this study will be randomly     assigned (having an equal chance of being in either group) to one of the two study groups     that will run for 6-months:      Group A: Receive 10-weeks of group parenting education sessions with 2-4 public health nurse     home visits Group B: Receive regular health care      In addition to the measures collected as part of TARGet Kids!, research assistants will     collect the following information about you and your child before the start of the trial, and     after 6-months:      Parenting Questionnaires from the parent Depression, Anxiety, Stress Scale (DASS-21) from the     parent A blood sample from your child      We will measure the differences in weight, height, social, emotional and behavioural health,     nutrition, physical activity, sleep, risk for heart disease and diabetes, and health care     use.   "
5057|NCT03219684|"     Nephrotic syndrome (NS) is among the most common pediatric kidney diseases and is defined as     massive proteinuria (>40 mg/m2/h or urine protein to creatinine ratio >2 g/g) leading to     hypoalbuminemia (<2.5 g/dL), edema, and hyperlipidemia. 60-70 % of patients present prior to     age of 6 years   "
5058|NCT03219671|"     A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma     (CKS)   "
5059|NCT03219658|"     This internal pilot study will determine whether a highly promising primary care based     intervention that combines group based parenting skills training and public health nurse home     visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight     status in 1 to 5 year old children with severe obesity.      Children with severe obesity will be identified through the obesity management clinical     program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management     Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity     management program designed for 1 to 5 year-olds with severe obesity and their families.     Families who participate in this study will be randomly assigned (having an equal chance of     being in either group) to one of the two study groups that will run for 6 months:      Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home     visits and four one-on-one check-ins with an interdisciplinary team at STOMP.      Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with     an interdisciplinary team at STOMP.      In addition to the measures collected as part of STOMP, families will complete the following     questionnaires before the start of the trial, and after 6 months:      Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21),     Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).   "
22105|NCT02996279|"     Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS)     and increased levels of proinflammatory molecules.   "
5060|NCT03219645|"     This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin     in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene     Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(300mg loading dose,then 100mg     once/day D2-D14) in combination, while the other half will receive aspirin(300mg loading     dose,then 100mg once/day D2-D14).   "
5061|NCT03219632|"     Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients   "
5062|NCT03219619|"     Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden     standard. However, side-viewing duodenoscope is not available in some endoscopic centers.     Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of     the scope has emerged as an alternative method for the observation of MDP. A recent study     showed that complete examination of MDP could be achieved in 97% of patients. The     investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of     MDP.   "
5063|NCT03219606|"     The aim of the study is evaluating the efficacy of organized education process of the     modified Rodnan Skin Score (MRSS) in the systemic sclerosis. Ten physician in South Korea     will be voluntarily enrolled and receive the organized training program, which encompass the     lecture and demonstration of skin scoring by expert rheumatologist. Reliability and accuracy     of the skin scoring before and after the education will be compared.   "
5064|NCT03219593|"     The study is to investigate the efficacy and safety of apatinib for the first-fine treatment     in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or     gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free     survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable     disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were     assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity     or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d     following the occurrence of a clinically significant adverse event (AE). Treatment will be     discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size     is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects     before the start of treatment, and detected using next generation sequencing (NGS)-based     comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or     safety will be explored.   "
5065|NCT03219580|"     This is a double (physician and patient) blinded randomized controlled clinical trial in     which patients who have undergone bilateral direct brow ptosis repair undergo a trial in     which one of brow is injected with placebo 0.9% Normal Saline and the contra-lateral brow is     injected with 0.3-0.6 mL over the entire brow of 50mg/mL 5-Fluorouracil sub-dermal     injections. The researchers aim to investigate whether injecting 5-Fluorouracil preemptively     will not only accelerate wound healing and decrease hypertrophic scar formation compared to     placebo, but also improve overall scar appearance in a safe manner.   "
5066|NCT03219554|"     This is a phase II single center, open-label, single arm study of palbociclib treatment in     patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic     chemotherapy regimens. Patients will receive oral palbociclib 125mg daily for 21days followed     by a 7-day break. Cycle will be repeated every 28 days.   "
5070|NCT03219502|"     The goal of this research study is to learn if using a type of therapy called repetitive     transcranial magnetic stimulation (rTMS) can help improve chemotherapy-related peripheral     neuropathy (CIPN). Peripheral neuropathy is nerve damage with possible numbness, pain, and/or     loss of motor function. Researchers also want to learn if it can improve quality of life and     mental health.      rTMS is designed to change brain activity by introducing small magnetic impulses to the scalp     that encourage the brain to change its activity.      In this study, rTMS will be compared to sham rTMS. Sham rTMS is not an actual treatment. It     is designed to look like rTMS, but does not treat any disease or illness. It will be compared     with rTMS to learn if rTMS has any real effect.   "
5082|NCT03219346|"     The prevalence of chewing dysphagia in the domestic rehabilitation department ward was about     53.61%.Nasal tube retention of about 31%, due to nasogastric tube feeding, often overlooked     oral hygiene, easy to cause respiratory tract infection. At the same time, oral hygiene will     also affect the effectiveness of swallowing treatment, is worthy of attention to health     problems.   "
5096|NCT03219151|"     This research project will evaluate a gamified electronic medication administration record     (eMAR) system simulator as a mechanism to improve students' learning of medication     administration in simulated clinical education. The gamified eMAR simulator will be evaluated     using a pragmatic randomized controlled trial design in order to determine the effectiveness     of the game as a technology-enabled, online learning intervention.   "
5071|NCT03219489|"     Progesterone can be given to women at risk for preterm birth, and is advocated by many     guidelines as progesterone has been shown to markedly decrease preterm birth, death in     newborns, and disability. However, not all eligible women are currently receiving this     medication. Thus, there is an urgent need to improve prevention of preterm birth with     progesterone. In response to the low number of women receiving this medication, the     investigators have designed a potential method to increase progesterone use.      This method involves the use of an alert programmed into electronic medical records, to     prompt doctors to prescribe progesterone to women at risk of preterm birth. This study is a     randomized controlled trial that will assess the feasibility of using this alert, by     randomly assigning 8 clinics to either use this alert, or to provide their usual prenatal     care. The investigators will then study whether the alert improved prescription of     progesterone, and examine neonatal outcomes such as preterm birth and birth weight. Care     providers will be asked for their feedback and thoughts about the alert, through     questionnaires and structured interviews.      The investigators hypothesize that the electronic medical record alert will increase care     provider recommendations and prescription of progesterone for women at risk of preterm birth.     The investigators hope that this study will lay the groundwork for larger future studies     aimed to strengthen health care quality and improve the health outcomes of women and their     babies.   "
5072|NCT03219476|"     This is an exploratory interventional study that initiates standard-of-care anti-estrogen     treatment preoperatively for four weeks.   "
5073|NCT03219463|"     The purpose of our graduate student research study is to observe the effects of ginger on     hsCRP, IL-6, and TNF-α levels in exercising individuals based on their level of activity.   "
5074|NCT03219450|"     This research study is studying a novel type of CLL vaccine as a possible treatment for     chronic lymphocytic leukemia (CLL)      The names of the study interventions involved in this study are:        -  Personalized NeoAntigen Vaccine        -  Poly-ICLC        -  Cyclophosphamide   "
5075|NCT03219437|"     The purpose of this study is to compare the safety and efficacy of risankizumab to     methotrexate in participants with moderate to severe plaque psoriasis.   "
5076|NCT03219424|"     To evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one     year after injury. To derive reliable prediction models for return to work.   "
5077|NCT03219411|"     The transition from normal glucose tolerance to overt type 2 diabetes mellitus (T2D)     encompasses a variety of glycemic abnormalities that are commonly referred to as     'prediabetes'. While intensive lifestyle interventions are the cornerstone of T2D prevention,     developing safe, cost-effective adjunct therapeutic strategies is a clinically relevant goal.     Cinnamon supplementation has been shown to improve fasting plasma glucose in patients with     T2D. This placebo-controlled, randomized study will determine if cinnamon improves glucose     homeostasis in patients with prediabetes over a 12-week period.   "
5078|NCT03219398|"     This study aimed to evaluate the increase of intraabdominal pressure 12- 14 mmHg caused by     pneumoperitoneum resulted from carbon dioxide (CO2) insufflation induce glycocalyx     endothelial injury that cause kidney tubular injury on live donor patient that undergo     laparoscopic nephrectomy surgery, and decreasing the intraabdominal pressure to 8-10 mmHg     during surgery is expected to reduce the injury.   "
5079|NCT03219385|"     The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis     System for treating uterine fibroids in women who are seeking relief from fibroid-related     abnormal uterine bleeding but want to avoid hysterectomies or other surgical procedures. The     Mirabilis System is an investigational device that delivers high-intensity focused ultrasound     (HIFU) to the uterus using integrated ultrasound imaging guidance to offer noninvasive     treatment for uterine fibroids. With the Mirabilis System, HIFU is applied noninvasively     through the skin using an applicator that is placed against the abdomen. No incisions or     surgical procedures are required. During this study, eligible patients will have one or more     fibroids treated with the Mirabilis System and will then remain in the study for a total of     36 months after treatment to monitor the occurrence of adverse events. Primary endpoints will     be assessed at 12 months after treatment, while secondary endpoints will be assessed at     variable times ranging from immediately after treatment up to 36 months after treatment.   "
5080|NCT03219372|"     Hepatocellular Carcinoma (HCC) is a major health concern in the United States, particularly     among people with liver cirrhosis. Out of every 100 patients with liver cancer, only 18 will     survive 5 years or more. While locoregional therapies are utilized in an effort to combat     this disease, the recurrence rate of HCC after these therapies are high.      Statins are widely used drugs that lower cholesterol levels. Some studies have suggested that     statins lower risk of HCC recurrence, but this possibility has not been studied thoroughly in     a clinical trial. This study will examine the effects of pravastatin, a type of statin, on     time to HCC recurrence in patients with early stage HCC. It is possible that pravastatin in     combination with locoregional therapies may delay or protect against HCC recurrence.   "
5081|NCT03219359|"     Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant     complications and discomfort in the stomach and intestines. Crohn's disease is a     debilitating, incurable disease of immune cells; it affects almost 1 million people in the     United States. CD is characterized by inflammation of the stomach and intestine as well as     organs outside of the intestines such as the skin, eyes, and joints. Current therapies to     treat CD aim to suppress the patient's immune cells but these therapies become ineffective     for the majority of patients and lead to complications including the requirement for surgical     bowel resection, impaired quality of life, and lifelong disability. Hematopoietic stem cell     transplantation (HCT) is a procedure used to treat a number of medical conditions including     Crohn's disease. To improve success of HCT in CD doctors considered combining transplant with     other drugs to improve the chances of achieving remission and also maintaining the remission.     The Investigators' plan in this study is to incorporate the drug Vedolizumab after transplant     to test if this drug will improve remission and make patients healthier.      Patients may qualify to take part in this research study because Crohn's disease is active,     because surgery is not a treatment option and because there is evidence that the disease has     failed to respond to treatments for Crohn's disease including the following:        -  corticosteroids        -  azathioprine, 6-mercaptopurine, methotrexate        -  Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)        -  Anti-integrin agents (natalizumab, Vedolizumab) If patients meet entry criteria will          undergo a baseline endoscopy, colonoscopy and MR or CT enterography. If documentation of          active mucosal disease patients will then be tapered off of current medications and          undergo stem cell mobilization. Mobilization will involve low dose chemotherapy, growth          factors and require 1-2 week hospitalization. Patients will then undergo stem cell          transplant which will involve high dose chemotherapy and require a 2-4 week          hospitalization. After restoration of the immune system patients will be placed on          vedolizumab per standard dosing (0,2,6 then every weeks). Patients will have monthly          study visits and a repeat colonoscopy and MR/CT scan at 6 months.   "
17495|NCT03056547|"     To explore biological mechanisms in human model of induced dyspnea, in order to remove the     source of dyspnoea, to modify cerebral impact and to allow the development of targeted     therapies.   "
5083|NCT03219333|"     This is a study that will test how an experimental drug (enfortumab vedotin) affects patients     with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of     the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other     areas of the body.      This clinical trial will enroll patients who were previously treated with a kind of     anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for     the treatment of urothelial cancer.      This study will test if the cancer shrinks with treatment. This study will also look at the     side effects of the drug. A side effect is a response to a drug that is not part of the     treatment effect.   "
5084|NCT03219320|"     To evaluate the efficacy of multiple dose levels of NYX-2925 versus placebo in treating the     neuropathic pain associated with Diabetic Peripheral Neuropathy.   "
5085|NCT03219307|"     This study is an extension of protocol AAG-G-H-1220; and is open only to participants of     AAG-G-H-1220 randomized to Microfracture. It is a prospective single arm clinical trial.   "
5086|NCT03219294|"     During many surgeries, increased muscle tension makes it harder for the surgeon to expose the     site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as     Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction,     blocking their action and producing muscle relaxation. This muscle relaxation allows easier     retraction of muscle tissues and manipulation of structures in the wound. Improved surgical     conditions are likely to result in improved patient outcomes. While increased depths of NMB     have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal     procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To     address this, we propose to study the effect of NMB depth on surgical conditions during total     hip replacement (THR).   "
5087|NCT03219268|"     The primary goal of this Phase 1 study is to characterize the safety and tolerability of     MGD013 and establish the maximum tolerated dose (MTD) of MGD013. Pharmacokinetics (PK),     immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of MGD013 will also be     assessed.   "
5088|NCT03219255|"     This study aims to investigate the long-term safety and efficacy of RELVAR® 100 ELLIPTA®     (hereinafter referred to as Relvar) in daily clinical practice in subjects with chronic     obstructive pulmonary disease (COPD), who are naive to RELVAR. A total of 1000 subjects, from     approximately 200 medical institutions, will be registered for this study and 332 of them     will be considered for safety analysis. In the investigation, subject registration and data     collection will be conducted using an Electronic Data Capture (EDC) system.     Post-registration, the investigator will monitor the information regarding the safety and     efficacy of RELVAR for one year from the start date of treatment with RELVAR. Pneumonia,     systemic effects caused by corticosteroids and cardiovascular events will be considered as     the priority investigation matters. At the end of observation period, the investigator will     enter the obtained information into the EDC system and submit it. RELVAR 100 ELLIPTA is the     registered trademark of GlaxoSmithKline (GSK) group of companies.   "
5089|NCT03219242|"     Longitudinal prospective study on primary debulking surgery including bowel resection in     advanced stage ovarian cancer patients using Caiman® technology   "
5090|NCT03219229|"     Young children have a high resting energy expenditure (REE) relative to their body weight and     metabolically active compartment, fat-free mass (FFM). Both body weight and FFM are, however,     metabolically heterogeneous and include organs and tissues varying widely in specific     metabolic rate (i.e., organ REE/kg/d). One prevailing hypothesis is that most, if not all, of     the higher REE observed in young animals and children compared to adults can be accounted for     by a larger proportion of high metabolic rate components such as brain, liver, and heart..   "
5091|NCT03219216|"     This is a Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of     Glecaprevir (GLE)/Pibrentasvir (PIB) combination for an 8 or 12-week treatment duration in     adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection, without     cirrhosis or with compensated cirrhosis, who are HCV treatment naïve.   "
5092|NCT03219203|"     This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV)     vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn     Chiang Mai Hospital.   "
5105|NCT03219034|"     This study will compare the effectiveness of the two leading oral appliances (OAs) designs     for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness     of OAs has come under question since different designs are combined in evaluating treatment     efficacy, for example when comparing them to continuous positive airway pressure Due to the     wide range of reported efficacy (53 to 90%), it is of great value to identify the most     effective design to guide sleep practitioners and patients.   "
5106|NCT03219021|"     The aim of the study is to assess arch dimensions among children with surgically repaired     unilateral cleft lip and palate.   "
5093|NCT03219190|"     This Fast-Track SBIR project is designed to address the critical need for an effective     primary prevention approach for prescription drug abuse (PDA), an urgent public health crisis     in the United States. The project involves developing and testing an innovative new approach     to the primary prevention of PDA among high school students utilizing e-learning and small     group facilitator-led intervention modalities. The intervention is an adaptation of the     evidence-based substance abuse prevention approach called Life Skills Training (LST). The     adapted intervention will address the relationship between PDA and alcohol, tobacco and other     drug (ATOD) use and abuse; positively change social norms surrounding ATOD and PDA;     discourage diversion of prescription medications; enhance protective factors by building     social and self-regulation skills through interactive learning and behavioral rehearsal     scenarios.   "
5094|NCT03219177|"     There is a current opioid epidemic in the United States partially fueled by excess     prescribing practices after surgery. The objective of this study is to decrease the amount of     opioids needed after ambulatory hand surgery. In this randomized control trial, patients will     be randomized into a patient education group and into a control group. The education group     will be provided with a pre-operative video detailing proper indications for opioid use after     hand surgery, alternative pain management strategies to try before using prescription opioid     medications, and side effects associated with opioid use. Patients will also receive     information on the current opioid epidemic. Patients will be reminded of the information     given pre-operatively after surgery in the post-anesthesia care unit. The control group will     not receive pre-operative education and will only receive standard of care post-operative     counseling by nursing in the post-anesthesia care unit. All patients will be given a pain     log, pain medication diary and participate in phone/email surveys to determine number of     opioid pills taken, pain levels, and satisfaction with surgery. The investigators hypothesize     that the education group will have decreased opioid intake and increased patient satisfaction     compared to the control group.   "
5095|NCT03219164|"     The primary objective of this study is to evaluate the safety and efficacy of a 14-day course     versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new     onset Pseudomonas aeruginosa respiratory tract infection.   "
5097|NCT03219138|"     Objective neuromuscular monitoring is the gold standard to detect postoperative residual     curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or     unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function     tests to identify PORC   "
5098|NCT03219125|"     The purpose is to determine in a case-control study if an association exist between bone     marrow adiposity and fragility fractures in post-menopausal women.   "
5099|NCT03219112|"     In this study the clinical relevance of the use of commercially available virtual reality     games in the rehabilitation of balance will be assessed in children with cerebral palsy. It     will be investigated how different commercially available platforms (i.e. Xbox One + Kinect     and Nintendo Wii + balance board) will affect the compensations of children with cerebral     palsy to preserve their balance. The effect of 1 training session will be assessed as well as     the effect of a long-term training of 8 weeks.   "
5100|NCT03219099|"     A novel methodology was recently developed and validated by the applicants to compute bone     strength at the distal radius and tibia using second-generation HR-pQCT reconstructions. The     methodology is expected to improve significantly the assessment of bone fracture risk in     idiopathic and secondary osteoporosis, but no reference data and no reproducibility data are     available.      The objective of the study is the determination of the sex- and age-specific distributions of     accurate distal radius and tibia strength assessed by HR-pQCT in the Swiss population.   "
5101|NCT03219086|"     Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared     to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial     is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both     with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant     larger amount of patients will gain surgical readiness within 8 minutes after spinal     injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical     readiness is defined as a sensory block level of T5 tested by loss of cold sensation.   "
5102|NCT03219073|"     Transcranial Direct Current Stimulation (tDCS) is a noninvasive brain stimulation technique     that utilizes low amplitude direct currents applied via scalp electrodes to apply currents to     the brain and modulate the level of cortical excitability. tDCS applied over the dorsolateral     prefrontal and motor cortex has been reported to be able to decrease pain sensation and to     increase pain threshold in healthy subjects and is effective in reducing central chronic pain     in patients with multiple sclerosis (PwMS.) In spite of the encouraging results of tDCS in     PwMS, detailed mechanisms accounting for its analgesic effect have not yet been elucidated.      This will be the first study to determine the effects of tDCS on whole and regional brain     activity in PwMS with neuropathic pain to identify potential mechanisms of the analgesic     effects of tDCS. These findings will provide targets for future studies investigating     different stimulation areas, possible short- and long-term side effects, and specific target     areas for other precise stimulation techniques such as transcranial magnetic stimulation.   "
5103|NCT03219060|"     This study's objective was to test the efficacy, acceptability and feasibility of a     motivational interviewing (MI) based smoking cessation intervention with nurses.   "
5104|NCT03219047|"     The goal of this clinical research study is to use xenograft models to test the effectiveness     of certain anti-cancer drugs in relapsed (has come back) or refractory (has not responded to     treatment) mantle cell lymphoma (MCL).      Xenograft models involve taking a piece of tissue from participant's tumor that was     previously collected and putting that tissue inside of a mouse in the lab. This allows the     tumor to grow in the mouse so that researchers can test the effects of certain drugs.      In this study, researchers will test the following types of drugs in xenograft models:        -  Drugs that are FDA approved and commercially available for the treatment of MCL        -  Drugs that are FDA approved and commercially available for other hematological          malignancies (blood-based diseases)        -  Study drugs/combinations that are currently being tested in other MCL clinical research          studies at MD Anderson        -  Study drugs/combinations that have been previously studied in other MCL clinical          research studies   "
5107|NCT03219008|"     Major Depressive Disorder is one of the most common mental diseases,which increases     health-care costs and the financial burden to families and societies. Considering its complex     clinical symptoms and diversity of comorbidity, depressive disorder's     recognition，diagnosis，and antihistone are based on symptomatology,which is lack of     multidimensional diagnosis technique based on clinical pathological characteristics,as well     as lack of individualized therapy strategy based on quantified evaluation. Besides, other     physical diseases，such as nervous system diseases, cardiovascular diseases，endocrine     diseases, have the high comorbidity of depressive disorder. However，there is no precise     diagnosis technique or standardized therapy strategy. With all those taken into     consideration,our study is aimed to adopt E-mental health and m-Health to explore     multi-dimensional diagnosis, individualized therapy and management technique based on     molecular biology,nerve electrophysiology，and neuroimaging technology etc.   "
5108|NCT03218995|"     This is a multicenter, open-label, dose-escalation study to evaluate the safety,     tolerability, PK, and efficacy of once-weekly IV infusions of eteplirsen in approximately 12     male patients, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD     with a deletion mutation amenable to exon 51 skipping.   "
5118|NCT03218865|"     Evaluation of the effect of a vitamin E coated high flux polysulfone dialyzer on the     inflammatory state of patients' end stage renal disease and its clinical benefits in terms of     anemia Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the     micro-inflammatory state of chronic dialysis patients Prospective multicenter controlled and     randomized study Number of patients : 120 patients (60 patients per group)   "
5109|NCT03218982|"     The purpose of this study is to develop and implement a culturally-appropriate intervention     to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test     the feasibility and acceptability of the intervention in a community setting. This will be     done by randomly assigning a family triad (primary caregiver, secondary caregiver, and their     care recipient) into an active intervention or a control condition and monitoring findings at     baseline, post-intervention, and at three months.The intervention will consist of multiple     components -enhanced psycho-education that includes discussion of Alzheimer's Disease (AD)     and cultural impacts on beliefs about dementia and caregiving, management of problem     behaviors, facilitation of support seeking, and mindful Tai Chi. A secondary caregiver who     the primary caregiver identifies as providing him/her with the most support will be invited     to join all components, but the intervention will be flexible depending on caregivers'     needs/preferences. The care recipient is not required to join the sessions but will be able     to if he/she or the family wishes. During the intervention, community partners will provide     respite care for the care recipient.   "
5110|NCT03218969|"     This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat     patients currently having dopamine agonist induced augmentation in restless legs syndrome.     Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week     wash-out period. Efficacy points will include the IRLS, augmentation scales, sleep scales,     clinical impressions and fatigue/mood scales.   "
5111|NCT03218956|"     It is well established that a breast-feeding women need more protein in their diet compared     to non-lactating women, but how much additional protein is needed remains unclear. There is     reason to believe that the current Dietary Reference Intake (DRI) recommendations for     breast-feeding women are too low. To gain better understanding, we plan to study healthy     breast-feeding women 20 - 45 yrs, between 3 - 5 months lactation and 6 - 8 months lactation.     We will use the indicator amino acid oxidation technique (IAAO), which is a modern, quick and     safe research method.   "
5112|NCT03218943|"     Background and Rationale :      Mechanical ventilation is an essential component of the care of patients with respiratory     failure.Biphasic positive Airway Pressure (BiPAP) and Airway Pressure release ventilation     (APRV) are relatively new modes of mechanical ventilation which can be used in treatment of     patients with impaired oxygenation.The effect of using BiPAP and APRV modes on reducing the     physiological dead space had not been previously investigated. The investigators hypothesize     that using APRV mode will decrease physiological dead space more than BiPAP mode in the     mechanically ventilated critically ill patients.      Objectives :      To assess the physiological dead space with each mode. To assess lung mechanics during the     use of the two modes. To assess the effectiveness of ventilation during the use of the two     modes.      Study population & Sample size :      Sixty adult patients more than 18 years old who are mechanically ventilated patients with P/F     ratio less than 300. This sample size was calculated based on the assumption that APRV will     decrease dead space by 20% with alpha error 0.05 and power 80%. The mean and Standard     deviation of the volume of the dead space assessed in a previous study using BIPAP was 40      Study Design :      A randomized controlled non-blinded study with cross-over design. In the Trauma and surgical     ICU at 185-Hospital (Kasr Alainy Hospitals).      Methods :      All mechanically ventilated patients in Trauma and surgical ICU at 185-Hospital (Kasr Alainy     Hospitals) will start on pressure controlled ventilation mode (PCV) with inspiratory pressure     achieving tidal volume 6-8 ml/kg for 2 hours then they will be randomized into one of the two     study groups the BIPAP group or the APRV group .      Possible Risk (s) to study population :      By adjusting the ventilator parameters properly and continuous monitoring of the patients in     the study, there will be no risk facing the patients.      Outcome parameter (s):      Primary outcome: Physiological dead space will be measured in the two groups after 30     minutes.      Secondary outcomes        -  Physiological dead space after 3 hours.        -  PO2/FiO2 ratio.        -  Peak airway and Mean airway pressures.        -  PCO2 and PH.        -  Dynamic compliance.   "
5113|NCT03218930|"     Antibiotic resistance has become a major threat to global public health. It is driven by a     multitude of factors, however one of the leading factors is antibiotic prescribing.     Inappropriate antibiotic use and overuse of broad-spectrum antibiotics can lead to the     development of resistant strains. Since in Malta the vast majority of antibiotics are     acquired through prescription, targeting providers' prescribing behavior is an important     strategy needed to try to curb antibiotic overuse and resistance.      The aim of this study is to evaluate the effect of a multifaceted social marketing     intervention in changing general practitioners' (GPs) antibiotic prescribing behavior for     patients with acute respiratory tract complaints in Malta. This quasi-experimental     intervention study using an interrupted time series design includes three phases; a formative     pre-intervention phase, an intervention phase and post-intervention evaluation phase, and     will last a total of four years.      During the pre-intervention phase, various stakeholders, including GPs, pharmacists and     parents will be interviewed in order to get a better contextual understanding of antibiotic     use in Malta. A 1-year baseline surveillance system will also be set up to collect actual     diagnosis-specific antibiotic prescribing by GP. This data will, at a later stage, be used to     measure the change in antibiotic prescribing behavior post-intervention stage. GPs stage of     behavior change and intention to prescribe antibiotics will also be measure pre-intervention     using questionnaires based on the theory of planned behavior and the transtheoretical model.      The intervention stage will last 6 months and will include multiple components, including,     delayed prescription pads, educational sessions, educational materials for patients and     distribution of antibiotic guidelines. The intervention will be monitored closely through     numerous process indicators.      Following the intervention, GPs' stage of change and intention to prescribe antibiotics will     be re-measured using the same questionnaire used pre-intervention. Surveillance data     collection will be also be resumed and will provide data to measure the primary outcome as     well as additional secondary outcomes.      The primary outcome of interest is the change in the rate of antibiotic prescribing for     patients presenting with an acute respiratory tract complaint.   "
5114|NCT03218917|"     The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a     24-week treatment period in patients with non-cystic fibrosis bronchiectasis.   "
5127|NCT03218748|"     The purpose of the study is to evaluate the feasibility and efficacy of the group-based     intervention Honest, Open, Proud among soldiers with mental illness.   "
5115|NCT03218904|"     Glycogen storage disease type I (GSD I) caused by deficiency of glucose-6-phosphatase enzyme     leading to buildup of a complex sugar called glycogen in liver and low blood glucose level.     Nutritional treatment involves supplying carbohydrates and uncooked cornstarch. Glycosade®     (modified cornstarch) has shown promise in maintaining normal blood glucose level in GSD I.     But the difficulty in nutritional treatment is determining the best type of carbohydrate to     be given to avoid low blood glucose. Thus, there is a need to develop a simple test to     examine glucose digestion and measure the utilization of different carbohydrates in GSD I and     healthy controls.   "
5116|NCT03218891|"     The purpose of this study is to evaluate the safety and feasibility of cardiovascular     rehabilitation in Patients with refractory angina, evaluate the effect of cardiovascular     rehabilitation in patients with angina Refractory, by maximal oxygen consumption (VO2max) and     global myocardial ischemic load by Stress Echocardiography; To evaluate the presence of     myocardial injury, caused by physical stress, through ultra-sensitive troponin after sessions     of aerobic physical activity, evaluating the behavior during the training period; To evaluate     the effect of rehabilitation on the modulation of sympathetic activity and inflammation,     muscular blood flow and lipid metabolism; To evaluate of the effect of rehabilitation on     ventricular function through Stress echocardiography; Detection of ischemic episodes and     arrhythmias identified during the Rehabilitation sessions through external cardiac monitoring     (telemetry); Evaluate the quality of life assessment through the SF-36 questionnaire,     Canadian Cardiovascular Society, the number of symptomatic episodes of ischemia, daily     sublingual nitrate intake.   "
5117|NCT03218878|"     This study seeks to evaluate pregnancy outcomes following hysteroscopic uterine cavity     expansion surgery for patients with dysmorphic uterine cavities and poor reproductive     histories. Patients already planning to undergo surgery at the recommendation of their     physicians will be recruited for participation.   "
5120|NCT03218839|"     This study will assess the safety of the PrePex device as applied to HIV positive men by     assessing the rate of clinical adverse events. The study will include adult, HIV + men who     are eligible to receive the PrePex procedure per the Zimbabwe Ministry of Health and Child     Care (MOHCC) eligibility criteria.   "
5121|NCT03218826|"     This phase I trial studies the side effects and best dose of PI3Kbeta inhibitor AZD8186 when     given together with docetaxel in treating patients with solid tumors with PTEN or PIK3CB     mutations that have spread to other places in the body or cannot be removed by surgery.     PI3Kbeta inhibitor AZD8186 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving PI3Kbeta inhibitor AZD8186 and docetaxel     may work better in treating patients with solid tumors.   "
5122|NCT03218813|"     Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal     and is associated with poor clinical outcomes. Patients' beliefs about medications have been     shown to predict poor adherence and may be targetable for intervention. Findings novel ways     to improve adherence is an important area of research with widespread clinical implications.     Pharmacists may currently be underutilised in promoting and monitoring medication-taking     behaviour. There have been few effective interventions led by pharmacists to support     medication adherence in patients with ACS.      Objectives This study follows on from a feasibility and acceptability study recently     conducted (NCT02967588). The primary objective is to pilot a pharmacist-led hospital-based     intervention to support medication adherence following an ACS.      Methods This study will adopt a non-randomised intervention cohort design (i.e. controlled     before-and-after (CBA) study). Patients admitted to hospital with an ACS will be recruited     for this study. Patients must be prescribed medicines for secondary prevention. The study     will be delivered by hospital pharmacists over two sessions and will target both intentional     (Session 1) and unintentional (Session 2) adherence barriers. Session 1 will involve     eliciting and challenging patients' erroneous beliefs about medications. Session 2 will     involve formulating specific action plans to encourage medication-taking habit formation.      Outcome Outcome data will be collected at two time points - 6 week and 12 week follow up. The     primary outcome of this proposed study will be treatment beliefs, measured using the Beliefs     about Medicines Questionnaire-Specific (BMQ-S) (Horne, Weinman & Hankin, 1999). Our secondary     outcome will be self-reported medication adherence measured using the Medication Adherence     Report Scale (MARS-5) (Horne & Weinman, 2002). Depression, medicines-related self-efficacy     and satisfaction with medicines information provision will also be measured.      Study timeline Control cohort ('before' group): eligible patients will receive treatment as     usual (TAU) and will complete all outcome measures (i.e. treatment beliefs, medication     adherence). Pharmacists will then be trained to deliver the intervention. Intervention cohort     ('after' group): eligible patients will receive the pharmacist-led intervention and will     complete all outcome measures.   "
5123|NCT03218800|"     Infections requiring intravenous antimicrobial therapy are very common events in patients     with advanced cancer. Nevertheless, these patients frequently present vascular damages     becoming extremely difficult to access and maintain intravenous route for hydration and     nutritional support. In this context, the subcutaneous route could be implemented as an     alternative route for replacement of fluids, electrolytes and drugs. Few studies have     evaluated the possibility of using the subcutaneous route for treatment of infections though.      Patients in palliative care often have infections caused by multidrug resistant bacterial     such as beta-lactamase producing bacteria. In this context, we hypothesize Ertapenem     subcutaneously is not inferior to the same drug intravenously for the treatment of urinary     infections in patients on oncologic palliative care. A non-inferiority clinical trial would     be adequate and could provide stronger evidence on the possibility of this alternative route     for antibiotic therapy in urinary tract infections, with important advantages such as greater     convenience of use.   "
5124|NCT03218787|"     The XIENCE Short DAPT Study is a prospective, multicenter, single-arm study designed to     assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with     any approved XIENCE family of Stent Systems.   "
5125|NCT03218774|"     The purpose of this study is to compare the effectiveness of 2 community intervention     approaches to maintain community mobility and walking speed in adults with cerebral palsy who     have previously completed an 8 week course of physical therapy.   "
5126|NCT03218761|"     DNA Acetylation can be responsible for significant down-regulation of transcription of the     Norepinephrine Transporter (NET). NET is an important clearance transporter that removes     norepinephrine (NE) from sympathetic neuronal synapses. Very low levels of NET can cause     Postural Tachycardia Syndrome (POTS) or make these patients more susceptible to certain     medications. Quantified NET messenger RNA (mRNA) levels from a peripheral blood sample may be     able to assess NET availability, which is simpler than older methods. This has not been     validated against NET function. In this protocol, the investigators seek to assess whether     these NET mRNA levels correlate with NET function. The investigators will assess the DHPG     (NET dependent NE metabolite):NE ratio in POTS patients and control subjects from both plasma     and urine samples.   "
5129|NCT03218722|"     Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of     patients with severe trauma) and is associated with increased mortality. ATC is associated     with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early     administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or     1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies     on fast supply of FFP.      To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to     use Prothrombrin Concentrate Complex (PCC) as alternative to treat coagulation factor     deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen     treatment, it is thought that PCC can be efficient in ATC management, while reducing risks     associated with massive transfusion.      ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at     showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the     management of patients at risk of massive transfusion.      Early administration of PPC should optimize patient blood management and therefore reduce     blood products transfused within the first 24 hours following a severe trauma.   "
5130|NCT03218709|"     To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism     in hyperuricemic adults.   "
5164|NCT03218267|"     Total hip replacement (THR) is the procedure which can improve the quality of life in     patients with osteoarthritis. However, deficits in static stability and impairment of the     lower limb efficiency can be observed even several months after procedure. The aim of this     study was to investigate the static balance of the standing position in patients treated by     THR.   "
5131|NCT03218696|"     The intent of this study is to see how boys and girls aged 1-5 and coughing since 1-2 days     due to common cold respond to a specific protective cough syrup taken before going to bed for     one night, with respect to a similar but not specific syrup (placebo). The symptoms evaluated     include especially cough frequency but also cough intensity, bother, and sleep quality of the     child and parents.   "
5132|NCT03218683|"     This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation     study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of     ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies.   "
5133|NCT03218670|"     A health education program was provided to higher education students aged between 18 and 25     years. Students were recruited either by posters and leaflets on campus, or during their     mandatory medical survey at the University Medical Department. The objectives are to assess     health behavior risk among college student : e.g eating disorders, binge drinking, electronic     cigarettes and also stress, burnout   "
5134|NCT03218657|"     The clinical symptoms of non transfusion dependent non severe aplastic anemia (NSAA) are     often lighter than that of severe aplastic anemia. Clinical observation is often used and the     treatment should be given according to the follow-up results of peripheral blood routine and     the survival condition of the patients. In recent years, a number of studies at home or     abroad have tended to intervene earlier. The risk of observation and waiting for disease     progression is higher. Early immunosuppression should be considered. For the treatment of non     transfusion dependent non severe aplastic anemia, the commonly used treatment regimen is     androgen combined with CSA. But the investigators find that Levamisole hydrochloride (LMS) as     a commonly used immunomodulatory drugs may be helpful to improving immune disorder symptoms     in NSAA patients. Therefore,the investigators are conducting a prospective, randomized     controlled study to compare the rate, side effects and long-term survival in non transfusion     dependent patients with NSAA between the androgen+CSA group and the androgen+CSA+LMS group.   "
5135|NCT03218644|"     Introduction: Neck pain is among the most common and costly for industrialized societies. It     is difficult to know the exact structure causing the pain so most are considered as     non-specific neck pain. There is a correlation between the alteration of craneocervical     proprioception and neck pain. The evidence for treatment with proprioceptive exercises is     very limited.      Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to     compare its effects with a cervical mobility program.      Materials and Methods: Subjects between 18-65 years old with traumatic or non-traumatic neck     pain are included. They will be randomized into two groups of exercises: proprioception or     mobility, which will be developed over a period of two weeks, every day, with a total of 10     sessions per patient.   "
5136|NCT03218631|"     To assess the pharmacokinetics and relative bioavailability of a single dose of approximately     0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a     small cohort of healthy adults.   "
5137|NCT03218618|"     The aim of such study is to compare three different school-based (in nurseries, kindergartens     and primary schools) interventions aimed at teaching to families how to prevent food choking     injuries.      The topic of food choking primary and secondary prevention is placed in a more general topic     regarding food safety, including education on food labeling and on food waste prevention.   "
5138|NCT03218605|"     Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of     Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as     to the most solid warming-up of the AT. Therefore, knowledge about activities which increase     blood flow in the AT could be useful in the development of a solid warming-up programme for     the AT. The aim of this investigation was to define the influence of different kinds of     physical activity on the vascularisation of the AT in a healthy asymptomatic population.     Subjects performed five activities in randomized order: running, static stretch, dynamic     stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was     measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before,     immediately after, five and ten minutes after activity to investigate the duration of the     vascular response to activity.   "
5186|NCT03217981|"     Research in the databases Lilacs, BIREME, SciELO by the terms: systemic inflammatory response     syndrome (SIRS), sepsis, severe sepsis and septic shock and their equivalents in the English     language. Selection of the main articles of the last five years to study and contextualize     the reality presented since the implantation of the HUVR sepsis protocol. Statistical     analysis of data since the implementation of the sepsis protocol in the HUVR, in July 2014     until June 2016.   "
24467|NCT02965404|"     The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in     healthy adults, adolescents, and children.   "
5139|NCT03218592|"     Purpose: Perform a 3-phase (single dose, multi dose, dose proportionality) study in healthy     volunteers using daily tenofovir+emtricitabine, dolutegravir, and maraviroc dosing to     quantify intra- and inter-subject variability and dose proportionality. The influence of     covariates on ARV hair distribution (e.g., hair growth rate, race, hair color, hair     treatment) will also be measured. Using both population PK modeling and physiologic based PK     (PBPK) approaches, a statistical model to quantify ARV adherence patterns based on signal     intensity/pattern will be developed.      Participants: Healthy volunteers, aged 18 to 70 years of age, inclusive on the date of     screening, with an intact gastrointestinal system and at least 1cm caput hair.      Procedures (methods): Participants will be sequentially assigned to enroll in a dosing arm,     beginning with maraviroc, then dolutegravir, and ending with tenofovir/emtricitabine. All     participants will take a single observed dose of study product in Phase 1, with blood and     hair samples obtained on Days 3, 7, 14, 21 and 28 days post-dose. In Phase 2, all     participants take 28 days straight of daily dosing, observed, of the same study product.     Blood and hair samples obtained on the same days post-dose. In Phase 3, participants will be     randomized to stop their drug, or decrease dosing to one or three doses weekly. Hair and     blood samples will again be obtained on the same days post-dose. All participants will     complete a follow-up safety visit with 14 days of completing study sampling.   "
5140|NCT03218579|"     The investigators would like to examine the extent of gut microbiome rehabilitation in     healthy people after the consumption of antibiotics.      Outcomes of probiotic treatment versus bacteriotherapy will be compared.   "
5141|NCT03218566|"     To determine the safety and efficacy of the Indigo Aspiration System for aspiration     mechanical thrombectomy in patients with acute submassive pulmonary embolism (PE)   "
5191|NCT03217916|"     we found different pattern of podocyte glycoproteins and kidney injury biomarkers in urine     specimens between preeclampsia and pregnancy complicated with chronic hypertention compared     with normotensive pregnant controls.abnormally elevayed urine biomarkers in severe     preeclampsia were completely or prtially reduced 6-8 weaks after delivery to levels     comparable with those of normal pregnant subjects.   "
17496|NCT03056534|"     R3 Delta Post-Approval Study U.S.   "
5142|NCT03218553|"     Postoperative complications are major healthcare problems and are associated with a reduced     short-term and long-term survival after surgery. Major surgery is associated with a     predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the     magnitude of the surgical trauma. An excessive SIRS syndrome participates to the development     of postoperative organ dysfunction, infection and mortality. Corticosteroids may decrease the     postsurgical SIRS in cardiac surgery: in a large multicenter randomized trial, a single     intravenous administration of high-dose dexamethasone did not reduce the incidence of a     composite endpoint of adverse events but was associated with a reduced incidence of     postoperative pulmonary complications and infections and with a reduction in hospital stay.     However, a similar study, recently published in the Lancet was negative. Evidences from one     meta-analysis, including 11 studies of moderate quality (439 patients in total), suggest that     intraoperative administration of corticosteroids during major abdominal surgery decreases     postoperative complications, including infectious complications, without significant risk of     anastomotic leakage. At present, no large randomized controlled trial has been performed in     patients undergoing major non-cardiac surgery. In acute medicine, several lines of evidence     have shown that low to moderate doses of corticosteroids decrease the excessive inflammatory     response, without inducing immuno suppression. However, despite the widespread use of     corticosteroids to reduce postoperative nausea and vomiting and to improve analgesia,     concerns continue to be raised about their safety, especially regarding an increased risk of     postoperative infection.      Hypothesis Patients treated with early continuous hyperosmolar therapy have reduced morbidity     and mortality rates compared to those receiving standard care alone after traumatic brain     injury.      Perioperative administration of moderate dose of dexamethasone reduces postoperative     morbidity and mortality after major non-cardiac surgery.   "
5143|NCT03218540|"     Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central     venous pressure (CVP), guidance results in better clinical outcomes.      Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine     level.      Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be     randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP     guidance.      Outcome analyses: Compare serum lactate, creatinine as well as other postoperative     complications between both groups.   "
5144|NCT03218527|"     Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis,     responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the     artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel     stenosis. One of the main features related to plaque progression and vulnerability is     inflammation. Positron emission tomography with 18-fluorodeoxyglucos (18-FDG PET) allows an     accurate quantification of plaque inflammation and it has been proved its usefulness in     predicting early stroke recurrences. The investigators aim to test how modifiable vascular     risk factors influence plaque inflammation assessed by 18-FDG PET. In addition, investigators     will assess the association of this inflammation and circulating endothelial progenitor cells   "
5145|NCT03218514|"     The main aim of this study is to compare the influence of total body-weight (TBW), lean     body-weight (LBW), ideal body-weight (IBW) or Body Mass Index (BMI) on peak anti-Xa levels at     steady-state in bariatric surgery (BS) morbidly obese patients receiving a fixed double dose     of dalteparin (5000 IU subcutaneously, twice daily a day) for venous thromboembolism (VTE)     prevention. Secondary aims of this study are to identify which body size descriptors (BSD)     has the greatest impact and could further be explored for an adjusted low molecular weight     heparin (LMWH) dosing algorithm for achieving optimal VTE prevention in BS severely obese     patients.   "
5146|NCT03218501|"     The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405     for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of     treatment.   "
5147|NCT03218488|"     The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric     participants (aged greater than or equal to 12 years to less than 18 years inclusive) with     moderate to severe plaque psoriasis, through monitoring for the following adverse events     potentially related to immune modulation: serious infections, malignancies and autoimmunity;     and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass     index) and development (sexual maturity based on the Tanner Scale).   "
5187|NCT03217968|"     The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program     device used at home for 2 hours to treat a migraine attack. This open clinical trial will     study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to     development of a sham-controlled trial.   "
10935|NCT03142776|"     To assess the local effect of the antimicrobial therapy using clarithromycin association with     photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).   "
5148|NCT03218475|"     Head and neck cancer is the sixth most common form of malignancy world-wide. Surgery,     chemotherapy and radiation are associated with a high burden of side effects; tumour     recurrence within the neck continues to be a major cause of treatment failure. To our     knowledge, this research is the first clinical study in human subjects to utilize magnetic     resonance guided focused ultrasound to treat cancer of the neck. The goal is to evaluate the     safety and technical feasibility of this therapy in order to guide future clinical     applications such as ablation, radiosensitization or drug delivery that could ultimately     improve clinical outcomes. A total of 10 patients will be treated with MR guided high     intensity focused ultrasound (HIFU).   "
5149|NCT03218462|"     Children with intellectual/developmental disabilities (ID/DD) will experience less dental     anxiety and cooperate better in a Sensory Adapted Dental Environment (modified visual,     sensory, and somatosensory stimuli in a regular dental setting) than in a regular dental     environment (RDE).   "
5150|NCT03218449|"     Infective complications after cancer surgery had a significant impact on disease-free and     overall survival. Postoperative inflammatory markers have been proven useful in predicting     infective complications. However, it remains unknown whether these markers can predict     postoperative infection in patients receiving cytoreductive surgery with hyperthermic     intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response     syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive     surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative     complications. Patients were divided into two groups according to the presence of infective     complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures,     or clinical signs and symptoms with comparable radiologic findings were defined as infective     complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio,     white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio,     albumin were collected from preoperative day and postoperative days (POD) 0-14.   "
5152|NCT03218423|"     This study will evaluate longitudinal performance of Epi proColon with respect to test     positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up     colonoscopy and diagnostic yield, as well as assay failure rates.   "
6747|NCT03197571|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with urothelial cancer who have progressed on or after chemotherapy and     anti- PD-1/PD-L1 therapy.   "
5153|NCT03218410|"     Acute pulmonary embolism (PE) is a serious and potentially lethal condition. The clinical     spectrum of PE spans from asymptomatic PE to patients with severe hemodynamic compromise. The     main determinant of outcome is right ventricular dysfunction caused by the abrupt rise in     pulmonary vascular resistance. Patients with hemodynamic compromise are at highest risk of     mortality (>15%). Hemodynamic stable patients with imaging and biomarker evidence of right     ventricular (RV)- dysfunction are at intermediate-high risk of mortality (3-15%). According     to the European Society of Cardiology (ESC) guidelines reperfusion therapy options for     patients at high risk and at intermediate-high risk include systemic thrombolysis,     catheter-directed therapy or surgical embolectomy.      The University Hospital of Bern is the only tertiary care hospital in Switzerland that has     established an interdisciplinary pulmonary embolism response team (PERT since 2010) and has     gained expertise in both catheter-directed thrombolysis and surgical embolectomy. Since the     introduction of PERT, systemic thrombolysis was no longer performed in Bern due to the high     risk of intracranial hemorrhage. Favorable clinical outcomes of the patients managed in Bern     have been published for both catheter-directed therapy and surgical embolectomy.      To date, no study has ever compared catheter-directed thrombolysis versus surgical pulmonary     embolectomy in the treatment of high and intermediate-high risk PE patients.   "
5154|NCT03218397|"     RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the     following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):        1. Standard culture and antimicrobial susceptibility testing (AST); or        2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the          Accelerate Pheno™ System (AXDX)   "
5155|NCT03218384|"     The purpose of this study is to better understand how body levels of iron affect the ability     to exercise in patients with heart failure.      Heart failure is a condition in which abnormal pumping action of the heart reduces the flow     of blood to the body. Patients with heart failure may feel shortness of breath or leg fatigue     when they exercise. Iron is an essential nutrient in the diet. In heart failure patients, low     body levels of iron might increase shortness of breath and fatigue.   "
5156|NCT03218371|"     The investigators compared the incidence of trimming-induced retinal breaks, retinal     redetachment rate, and final LogMAR BCVA; between scleral self-indentation and     non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with     primary retinal detachment. Self-indentation enables complete trimming of the vitreous base     without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with     less need for chandelier shift than with non-indentation approach.   "
5157|NCT03218358|"     intra-abdominal hypertension (IAH) and delirium are serious, high-frequency complications in     intensive care unit (ICU) patients. The consequences of the complication range from high     morbidity and mortality to a greater need for nursing care. We hypothesize that there could     be a correlation between IAH and incidence of delirium.   "
5158|NCT03218345|"     Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung,     kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows     EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in     the porcine pancreas and was used to treat small groups of patients that are not suitable for     surgery suffering from pancreatic neoplasms.      The aim of the current study is to perform a multi-center prospective study on EUS-guided     radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that     EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.   "
5252|NCT03217123|"     A prospective, randomized, double-blinded study was conducted in 7 OCD patients during which     4 electrode contacts along a striatal axis were stimulated bilaterally. DBS electrode     implantation followed a trajectory placing contact zero in nucleus accumbens (a common target     for OCD treatment) with more proximal contacts placed in striatal segments defined using     projections from prefrontal cortex subdivisions (ventromedial, orbitofrontal, dorsolateral)     and anterior cingulate cortex.   "
5159|NCT03218332|"     to examine the relationship between repeated concussions and late decline of brain function.     In addition, all participants agreeing to participate in the study will be asked to will     their brains to The Krembil Neuroscience Centre Concussion Project at the Toronto Western     Hospital with the consent and full knowledge of their families and doctors. However, it is     possible to participate in the research without agreeing to a brain donation.      The Project Team is specifically attempting a clinical-MRI-brain tissue research analysis to     determine the exact mechanism of the damage to brain tissue following repeated concussions.     This condition is known as chronic traumatic encephalopathy (CTE), and shows an abnormal     protein in the brain called tau-protein.   "
5160|NCT03218319|"     This study evaluates the impact of nephrectomy in renal cancer on blood pressure and renal     function. The patients will have a follow-up of their blood pressure and renal function until     6 months after their operation.   "
5161|NCT03218306|"     The study is aimed at confronting a surgical pleth index based protocol for intraoperative     analgesia in a desflurane based general anesthesia for thyroidectomy, versus a standard     clinical approach. A reduction in analgesic consumption and improvement in hemodynamics are     expected.   "
5162|NCT03218293|"     Remote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against     ischemia in various settings. However, the effect of RIPC in patients with acute ischemic     stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized     controlled trial, we examined the effect of RIPC on the resolution of nerve function     deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5‑min     cuff inflation followed by 3‑min deflation to the bilateral upper arm after thrombolysis. The     primary endpoint was the recovery of nerve function deficient assessed by National Institutes     of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS),     CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the     following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF),     basic fibroblast growth factor (bFGF).   "
5163|NCT03218280|"     Critically ill polytrauma patients have a number of physiological disorders secondary to     trauma, such as systemic inflammatory response (SIRS), adult respiratory distress syndrome     (ARDS), sepsis, oxidative stress (OS), and finally the multiple organ dysfunction syndrome     (MODS). Another important aspect in terms of clinical outcome is the energy-metabolic status.     Numerous studies have shown that implementing antioxidant therapy, capable of reducing the     expression of pro-oxidative, pro-inflammatory and energetic-metabolic status, the mortality     rate in critical patients decreases statistically significant. In this research paper, will     be implemented a multimodal monitoring protocol that covers the use of biochemical, genetics     and epigenetics biomarkers and the use of non-invasive medical devices to assess and monitor     critical polytrauma patient. Also will be optimized the antioxidant treatment plan according     to the needs of each patient.   "
5165|NCT03218254|"     Cancer related fatigue (CRF) is the most debilitating problem for patients with     haematological cancer. CRF severely reduces quality of life (QoL), functional capacity,     impacts health behavior, recovery and furthermore no approved treatment exists. In solid     cancer methylphenidat (MTP) has been suggested to improve CRF, however patients with     haematological cancer has not been studied. The current randomized placebo controlled study     includes a variety of severely fatigued haematological cancer patients from seven Danish     departments. It aims at revealing whether MTP can improve CRF, functional capacity and QoL     thereby hopefully providing improvement and treatment options in this field where     improvements are requested the most by patients. Patients are randomized to treatment with     MTP or placebo week 1-6 followed by wash-out and cross-over - placebo to MTP or vice versa     - during week 8-13. End-points will be patient reported fatigue, as well as improvements in     active hours, functional capacity, and QoL.   "
5166|NCT03218241|"     This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose     study of PRT064445 or its matching placebo, in healthy subjects.   "
5167|NCT03218228|"     The aim of the present study is to evaluate the health of immediately placed dental implants     in aggressive periodontitis patients versus those placed in periodontally healthy individuals     in the maxillary esthetic zone.   "
5168|NCT03218215|"     Background Mechanical assistance cough for patients with neuromuscular disorders (NMD) are     known, but there is no adaptation model established. Currently is performed subjectively by     the physiotherapist following the pressures recommended in the current literature as optimal     (±40CmH2O). To check is these pressures are the most optimal pressures to achieve the better     peak cough flow (PCF) monitoring cough assist (Mechanical insuffllation-exsuflattion MI-E)     maneuvers and analyzing pressure- flow / time curves      Adults with MI-E criteria (PCFbaseline <160 l /min). A pneumotachograph, PeakAnalysis     software and nasobucal mask were used to monitor and analyze flow/time curves. Protocol     included 9 PCF values in each patient: 1 baseline, 4 related with inspiratory pressure in     sequential increase of 10 cmH2O (10 to 40 cmH2O) and 4 adding expiratory pressures (±10 to     ±40cmH2O)   "
5169|NCT03218202|"     Two thirds of patients with Crohn's disease require intestinal surgery at some time in their     life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring,     are the most common reason for surgery. Despite the high frequency, associated disability,     and cost there are no are no treatment strategies that aim to improve the outcome of this     disease complication. The STRIDENT (stricture definition and treatment) studies aim to     determine biochemical and imaging features associated with the development of strictures and     in related STRIDENT studies develop strategies for treatment.   "
5196|NCT03217851|"     Study is cross-sectional and observational with one-time dried-blood spot sample collection     from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or     monoinfection). Samples will be analysed for the presence of molecular markers of resistance     to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene     amplifications of pfpm2, and additional mutations which may be identified during the course     of the trial) in the first instance. Testing to detect additional markers of antimalarial     drug resistance will also be performed where feasible. Prevalence of mutations will be     summarized and mapped to provide intelligence on antimalarial drug resistance in the region     of interest.   "
11657|NCT03133325|"     This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine.      There is a 12-week follow-up period. AEs will be recorded throughout the study.   "
5170|NCT03218189|"     The World Health Organization (WHO) has developed a model list of more than 400 medicines and     recommends that each country adapt the list to its own circumstances. More than 100 countries     have developed essential medicines lists.      Some countries have essential medicines lists that are very similar to the WHO's model list     and other countries have lists that are very different from the WHO's model list. Differences     between the WHO list and country lists could be explained by features of the country     including population demographics, disease prevalence, Gross Domestic Product (GDP), and     healthcare system organization. Other factors such as the influence of particular individuals     or organizations may also explain differences between countries.      The purpose of this project is to compare the essential medicines lists developed by     countries with the WHO's model list and to identify attributes of countries that are     associated with differences from the WHO list. Predictors such as region, population, life     expectancy, infant mortality rate, GDP per capita, health expenditure per capita, inequality,     and the corruption perception index will be considered.   "
5171|NCT03218176|"     A tourniquet is used to stop abundant bleeding when simple compression is not effective. The     investigators will study the vascular suffering of the tourniquets according to their     location on the limb: limb (arm / thigh) or distal (forearm / leg). Vascular suffering will     be evaluated by the loss of the radial doppler flux for the tourniquets placed on the upper     limb and in the tibial anterior to the lower limb by the loss of the pulse oximetry pulse and     the collection of the signs described by the volunteers (pain, Paresthesia, cold sensation).   "
5172|NCT03218163|"     Determine the progression free survival of high-risk or relapsed MM patients undergoing     non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance     therapy with MEDI-551.   "
5173|NCT03218150|"     Prospective, comparative, observational study.      The project's aim is long term follow up of patient's having skull bone defects due to     traumatic or lesion resection causes, treated , in standard clinical practice, with     autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and     safety among the 3 types of treatment.      Eligibility to each treatment will respect the standard clinical practice.      Primary outcome: minimize post operative infection      Secondary outcomes: decrease operation time , clinical and psychological improvement of the     patient, decrease the cost on the patient   "
5174|NCT03218137|"     Unblinded, controlled, non-randomized, mechanistic study to determine whether physiological     mechanisms underlying PVC are sensitive to adenosine. Twenty subjects undergoing     clinically-indicated, standard-of-care cardiac electrophysiology study (EPS) procedure for     PVCs will receive adenosine to learn if their arrhythmias are inducible similarly to     sustained ventricular tachycardia.   "
5175|NCT03218124|"     The study is aimed at determining the remifentanil effect site concentration suppressing the     cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane     based general anesthesia, expressed as median and 95th percentile effective dose.      Possible hemodynamic instability, respiratory depression or prolongation of awakening time     are also sought.   "
5176|NCT03218111|"     This study is being done in order to see how gadolinium-based MRI contrast (Magnevist)     travels through the central nervous system (CNS) when injected through the spinal column, and     to compare differences between two age groups (age 20-50, and 51-80). This will allow     investigators to evaluate how much contrast has crossed into the tissue surrounding the     brain. Such information will help investigators determine whether this kind of contrast can     be used to model how other drugs might travel through the CNS and evaluate its use as an     illustrative imaging marker that mirrors the glymphatic system.   "
5177|NCT03218098|"     Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better     Recovery?      Postoperative pain control remains one of the most common problems after major lung     resection. Pain is considered a major independent factor responsible for increased     perioperative morbidity and mortality: in particular, in patients with preoperative     compromised clinical conditions. In fact, acute pain may compromise the patient's     mobilization and the secretion's clearance with secondary possible bronchial obstruction and     parenchymal lung infection.      Today, the treatment of postoperative pain after lung resection is based on association of     the pharmacological therapy, including systemic use of opioids and non-steroid drugs,     epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive     surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve     protection with the use of muscle sparing. In the literature, reduced tissue damage     consequent to the use of limited surgical approaches is reported to be significantly     effective in decreasing early postoperative pain. Thus, the use of a minimally invasive     surgery for lung resections has proved to produce more tolerable pain and allow quicker     functional recovery and lower postoperative complications. The aim of this prospective     randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared     to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of     postoperative pain results. Primarily, to evaluate the differences of operative time between     the groups.      Secondly, to investigate the differences of pain scores between the two groups and the impact     of pain reduction on functional results.   "
5178|NCT03218085|"     Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed     and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma,     peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected.     Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome     will be evaluated to understand the role of hormones, inflammation, and the microbiome in     modulating drug efficacy in the female genital tract.   "
5179|NCT03218072|"     To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential     rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.   "
5180|NCT03218059|"     Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that     occur after a prior cesarean delivery. No clinical guidelines have been issued for the     management of CSP. More than 30 treatment methods are reported to be used in managing CSP.     However, which management can achieve better clinical effects remains unknown. Therefore,     this prospective study is designed to compare the outcome between MTX + transvaginal surgery     and UAE + D&C in the treatment of CSP.   "
24483|NCT02965196|"     The study will evaluate the efficacy of IV Dexamethasone in treatment low back pain as an     adjunct to analgesics.   "
5181|NCT03218046|"     Tinnitus may be considered as a form of phantom auditory sensation and as such parallels may     be drawn with other forms of phantom sensation, such as the sensation of pain in an amputated     limb (phantom limb pain). There has been recent interest in the use of eye movement therapies     to treat patients with phantom sensations such as these. The role of eye movements in the     propagation and maintenance of tinnitus has also been well established. The main aim of this     study is to evaluate the effectiveness of an established form of eye movement therapy called     Eye Movement Desensitisation and Reprocessing (EMDR). This research is important as EMDR has     produced encouraging results for other forms of phantom sensation and current models of     tinnitus fit well with the proposed mode of action of EMDR. Tinnitus is very prevalent in our     population and is often associated with significant discomfort; however, there is a severe     lack of effective treatments based on well designed clinical trials. The investigator wishes     to assess the usefulness of EMDR against the current treatment that is available in many     institutions including the Investigator's own. The Investigator intends to recruit 15-30     patients initially to run a pilot study, before embarking on a larger scale study. The     Investigator hopes that this pilot study will run over the course of a year. If this study     demonstrates a significant improvement in tinnitus in patient undergoing EMDR, this will be     an important step forward not only for treating patients with this disorder, but also for     understanding the pathways that initiate, propagate and maintain tinnitus perception.   "
5182|NCT03218033|"     The goal of this study was to examine the effect of an online educational program with and     without a social media experience.The primary goal of this study was to determine whether     medication adherence would be improved by having adolescents and young adults with systemic     lupus erythematosus participate in an online educational website, with or without a social     media experience. The secondary goal was to determine whether secondary outcomes such as     quality of life, stress, and self-efficacy improved in this model, and whether these changes     were associated with improvements in medication management.   "
5183|NCT03218020|"     Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat     consumption affects iron status and has also been shown to be related to increased CVD risk.     The investigators hypothesized that risk associations between red meat intake and     cardiovascular disease risk can to some degree be explained by higher iron load among     individuals with higher meat intake. Thus, the investigators evaluate associations between     red meat consumption, iron status, and CVD risk in a large-scale population based study, the     European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.   "
5201|NCT03217786|"     Heart transplantation is an effective life-saving treatment for patients with end-stage heart     disease. After a transplant, the new heart may develop narrowing in the arteries, causing     heart failure, heart attacks and abnormal heart rhythms. This condition is known as cardiac     allograft vasculopathy (CAV). The disease is very common, affecting almost a third of heart     transplant patients by 5 years after transplant. CAV is a serious problem that causes the new     heart to fail and is one of the main causes of death after transplant. Early detection of CAV     is important as treatment options are poor once the disease is established. Currently,     available techniques to evaluate CAV are limited by poor ability to detect disease early. The     current tests usually focus on the large heart arteries and do not examine the smaller     arteries that are also affected.   "
5202|NCT03217773|"     This is a prospective randomized controlled trial that aimed to compare the short-term     clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic     submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal     neoplasms.   "
24784|NCT02961270|"     This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in     non-small cell lung cancer patients harboring uncommon EGFR mutation   "
5184|NCT03218007|"     One proposed strategy is the stratification of troponin-negative patients with biomarker     testing at presentation to facilitate the clinically-appropriate rapid discharge from the     emergency department of patients who present with low-intermediate risk chest pain, and     conversely to triage appropriate Non sustained ST elevation acute coronary syndrome     (NSTE-ACS) patients to Cardiology beds, stress and non-invasive imaging modalities.     Biomarkers such as high-sensitivity troponin (hs-cTn), heart-type fatty acid-binding protein     (H-FABP), CRP, brain natriuretic peptide (BNP); and copeptin and ischemia-modified albumin     are an important advance for diagnostic testing for ACS (4). Regarding novel biomarker     testing at presentation, the addition of these biomarkers demonstrated increased sensitivity     at an acceptable QALY threshold, but more evidence is needed (5,6). A reliable method for the     diagnosis of minimal cardiac ischemia would meet a strong demand for the sensitive diagnosis     of coronary artery disease in patients with chest pain but unremarkable ECGs and biomarkers.     Adenosine is an endogenous nucleoside cardioprotective agent. Its cardiovascular effects are     mediated throught the activation of A2A Receptor (A2 AR) and play a major role in the     regulation of Coronary flow CF. As altered coronary blood flow occurs in patients with CAD,     it has been showed that that A2AR expression and functional activity play a role in CAD. In a     previous studies the team have developped an agonist-like monoclonal antibody to study     expression level of this receptor and their functional activity. Recently , Gariboldi     demonstrated that measuring the expression level of A2AR on peripheral blood mononuclear     cells ( PBMC) represents a good tool to address in situ expression in coronary tissues of CAD     patients.   "
5185|NCT03217994|"     The present study investigates whether it is possible to achieve equally satisfactory results     between 37.5% hydrogen peroxide gel and 6% gel for teeth bleaching. A prospective,     double-blind, randomized clinical trial was carried out. A total of 33 patients were selected     from the clinic of the Faculty of Dentistry at the University of Chile. The patients included     men and women over 18 years old without prior tooth whitening treatments, tooth decay, or     restorations of the upper front teeth. The patients had tooth colors of A3 or less according     to the Vita Classical scale, which was determined with a Vita Easy® Shade spectrophotometer.     The study was carried out with a split-mouth design. One side of each mouth was randomly     treated with 37.5% hydrogen peroxide, and the other side was bleached with 6% hydrogen     peroxide. Each group received 3 to 12 minutes of treatment with the respective gel     applications. Two sessions of bleaching were carried out each week. Color was assessed at 7     different sessions for 3 months. The spectrophotometer was used to measure the total     variation of color (ΔE) between the baseline (session 1) and different measurement times     (sessions 2-7). We compared ΔE for both agents using the Mann-Whitney test.   "
5188|NCT03217955|"     Rationale: There is growing consensus that targeting negative symptoms such as social     withdrawal is essential to be able to preserve social participation, thereby reducing the     high yearly costs of schizophrenia. Aaron T. Beck, founder of Cognitive Behavioural Therapy     (CBT), and colleagues have developed and investigated a new CBT approach, in which they     target inactivity in a chronic schizophrenia population with severe negative symptoms The     therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with     neurocognitive impairments can impede social functioning. These results suggest that CBT can     be highly successful in establishing clinically meaningful improvements. However, the therapy     has not yet been investigated in a recent-onset population.      Objective: To evaluate the applicability and (cost-) effectiveness of a shortened, partly     group based, Cognitive Behavioural Therapy focussing on social activation (CBTsa) in patients     with recent onset schizophrenia.      Hypotheses: 1) the investigators hypothesized that CBT focused on social activation (CBTsa)     in a recent-onset population will result in a substantial reduction in severity of negative     symptoms, in particular social withdrawal.      2) The investigators expected that CBTsa would lead to an improvement in terms of Quality of     Life and overall functioning.      3) The investigators expected this intervention to result in a reduction in need for care and     QALY gain as a consequence of improvement in symptoms and social functioning.      Study design: Single blind randomized controlled trial with 6 month-follow up. Study     population: Patients between 18 and 35 years old with negative symptoms of at least moderate     severity, and who have been recently (< 2yrs) diagnosed with schizophrenia.      Intervention (if applicable): Individual and group-based CBT intervention targeting social     withdrawal.      Main study parameters/endpoints: Change in negative symptoms, Social functioning, and quality     of life, Productivity losses.   "
5189|NCT03217942|"     The purpose of this study is to investigate and determine the time course and distribution on     muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized     that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle     soreness in a same manner (effect of duration) as for dosages previously used in NGF studies.     Furthermore, it is also speculated if several injections of low dose NGF into the muscle     combined are able to course immediate pain sensation and spreading of muscle     hypersensitivity.   "
5190|NCT03217929|"     Background: Obesity is one of the most important diseases around the globe; with a continuous     increase and public health concern. Current treatments present some limitations. Craving is a     symptom usually noticeable and has been described as a strong desire or urge to use,     especially with foods. The vagus nerve and its relations to the neurocircuitry of the reward     system play essential roles in food intake regulation and this can be done transcutaneously     trough the auricular branch of the vagus nerve (taVNS). Based on the neurobiology of food     craving and on the initial data on taVNS demonstrating safety and efficacy in open-label and     randomized sham controlled trials, the investigators propose the first randomized, sham     controlled, triple-blind trial on taVNS for food craving in obesity.      Methods: This will be a two-arm, triple-blinded, randomized controlled trial with 54 subjects     with food craving assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2)     a 10-session treatment protocol of sham taVNS, besides qualitative electroencephalogram     (qEEG) and heart rate variability (HRV). Participants will be evaluated for primary outcome     measures (Food Craving Questionnaire - State [FCQ-S] and Food Craving Questionnaire - Trait     [FCQ-T]) before and after intervention, with a follow-up visit of 30 days after the end of     treatment. A comparison between sham and active groups will be performed in three occasions     [baseline (T1), at the end of the stimulation protocol (T2) and 30 days after the last day of     stimulation (T3)].      Discussion: Given the epidemiological situation and economic and social burdens, the     possibility of modulating the reward system neurocircuitry trough the vagus nerve with an     easy-to-use, low-cost, safe and potential at-home use could represent a breakthrough in     treating obesity. The investigators hypothesized that food craving in obese individuals would     decrease at least 50%, as well as their intake of high fat, high sugar and processed food,     commonly described as palatable foods. Beyond that, the investigators expect that these     individuals would improve anxiety symptoms.   "
5192|NCT03217903|"     Myelodysplastic syndromes (MDS) are the most frequent myeloid neoplasms in Western     Countries.They mainly affect patients aged 65 years or older. This is a very heterogenous     group of diseases, which prognosis is evaluated with International Prognosis Scoring System.     High risk MDS present with high frequency of transformation into acute myeloid leukemia.     Treatment of high risk MDS often is based on hypomethylating agents, such as 5'-azacytidine     (Azacytidine), with a complete response in approximativel 20% of cases..      This treatment is based on 4-week cycles, with daily injection during the first week and rest     during the 3 next weeks of the cycle.      Azacytidine efficacy is commonly evaluated with clinical and biological parameters determined     by the International Working Group 2006. These parameters are usually evaluated after at     least 6 cycles of treatments.      There is a response with Azacytidine treatment in 60% of cases, including 40% of partial     responses and 20% of complete responses. In 40% of patients, there is no response, which     means that the disases is stable or in progression under therapy.      In this regard, early evaluation of treatment response is an issue. We want to improve our     knowledge about early response criteria in Azacytidine-treated high-risk MDS, focusing on SMD     with excess blasts, which represent 30 to 40% of total MDS.      Then, the investigator team want to compare DNA methylation profile at diagnosis and after 3     cycles of Azacytidine treatment.      Main objective :      Identify DNA methylation profiles related to response to Azacytidine therapy, after only 3     cycles of treatment, in high risk MDS with excess blasts.      Secondary objective :      Identify at diagnosis DNA methylation profiles that are predicitive of response to     Azacytidin, in high risk MDS with excess blasts.   "
5193|NCT03217890|"     Direct benefit of the research to assess the relationship between cleft lip and / or palate     (different types) and ABO blood groups.   "
5194|NCT03217877|"     The primary objective of the POST-PCI trial is to compare the clinical outcomes of a     post-percutaneous coronary intervention(PCI) aggressive management strategy of routine     noninvasive functional testing to a usual-care strategy of symptom-oriented functional     testing in patients with high risk clinical, anatomical, and procedural characteristics who     received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.   "
5195|NCT03217864|"     Hospitalization at home is booming. It is designed to meet the demands of patients and their     families to continue care at home. It partially solves the problem of the lack of places in     the long-term care structures and allows to respond to a desire of the health policy to     reduce the lengths of stay in the hospital. Hospitalization at home is also an alternative in     the management of chronic patients. Nevertheless, at the moment a certain number of requests     for hospitalization at home remain unsuccessful or their implementation is complicated. In     addition, the number of home health care provider has increased significantly in recent     years. According to the federation of home health care provider, the number of beneficiaries     increased by 1.7% in 4 years. The home health care provider would support 1,200,000 patients     per year.      The objective of the study is to analyze the factors participating in Implementation of a     return home with a Hospitalization at home or a home health care provider during a return     home project constructed with the patient and his / her relatives from the services of     Oncology, oncology, hematology of the University Hospital of Strasbourg.   "
5226|NCT03217461|"     The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial     autograft is more effective than femtosecond laser-assisted limbal autograft for ocular     surface reconstruction after excision of limbal dermoid.   "
5197|NCT03217838|"     This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), safety,     tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 in patients with relapsed     AML/high risk myelodysplastic syndrome or treatment-naïve patients not eligible for intensive     induction therapy or allogeneic transplantation. The study was also explore the potential     clinical activity by assessing anti-tumour activity in patients. The study will be conducted     in two parts, designated Part A, dose escalation, and Part B, dose expansion.   "
5198|NCT03217825|"     The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more     pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients     carrying at least one of the pre-specified gene mutations. In previous studies has been     demonstrated that these mutations are able to induce specific alterations inducing an     increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood     pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of     these alterations, and so directly reverse the increase in blood pressure.   "
5199|NCT03217812|"     The purpose of this study is to determine if the addition of daratumumab to     VELCADE-melphalan-prednisone (VMP) will improve very good partial response (VGPR) or better     compared with VMP alone.   "
5200|NCT03217799|"     The investigators have developed an optical system that measures the coagulation status of     patients in vivo in a non-invasive manner. The system is based on a small optical sensor that     emits coherent light into the skin and collects the reflected light from the red blood cells     in the blood vessels in the skin under the sensor. The sensor is placed on the fingertip, and     during a brief period of occlusion of blood flow by a small pneumatic cuff, red cell movement     becomes Brownian in nature and is thereby affected by the viscosity of the blood. In patients     who have a bleeding tendency, red blood cell movement will be faster, while in patients with     a hypercoagulable state the red cell movement will be slower. Treatment with anticoagulant     medications is expected to affect the movement of the red blood cells and these changes can     be detected by the sensor. The investigators plan to test the device in normal subjects and     in subjects taking Coumadin, direct oral anticoagulants, antiplatelet drugs and heparin-based     medications. The investigators will determine whether anticoagulants affect the noninvasive     measurement and compare the results with standard laboratory tests of coagulation.   "
7240|NCT03191097|"     The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective     and safe in the treatment of influenza and other acute respiratory viral infections in 7-12     years old patients.   "
5203|NCT03217760|"     The aim of this pilot study is to examine the patient's induced stress and the young     dentist's induced stress, during endodontic treatment. This study is carried out using     physiologic (cortisol measurement, arterial pressure and heart rate) and psychological data     (VAS visual analog scale of stress, pain and discomfort, CORAH and HAD Scales) collected from     patients of Brest University Dental Hospital at various stages of root canal treatment. The     endodontic treatment is carried out under the usual standards and practices.   "
5204|NCT03217747|"     Objectives:      Primary Objectives:        -  For Arms C-G, to establish the safety, tolerability, and dose-limiting toxicities (DLTs)          of different treatment combinations of avelumab when administered in combination with          checkpoint agonist(s) with or without radiation, or radiation and cisplatin in patients          with limited, locally advanced or metastatic solid tumors in order to estimate the          maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D).        -  To correlate pre- and post-treatment CD8 expression with clinical benefit (complete          response [CR], partial response [PR], or stable disease [SD] for > 6 months).      Secondary Objectives:        -  To evaluate the efficacy of the different treatment combinations in patients with          limited, locally advanced or metastatic solid tumors by assessing objective response          rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and          immune-related RECIST (irRECIST).        -  To evaluate the efficacy of the different treatment combinations in patients with          limited, locally advanced or metastatic solid tumors by assessing progression-free          survival (PFS), duration of response (DOR), and overall survival (OS).   "
5205|NCT03217734|"     Assess the efficacy and safety of ADA compared to ADA/MTX in patient with Psoriasis. Compare     Anti-ADA antibody formation and serum ADA levels in patients on ADA compared with those on     combination ADA and MTX.   "
5206|NCT03217721|"     Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than     <1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic     shock. The mortality risk is higher risk. The recommendations published in 2016 were     formulated to homogenize the clinical practices to improve the survival.   "
5207|NCT03217708|"     The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart     rate, skin temperature, sleep, and activity) in the post surgical discharge period to     identify trends which correlate with improved outcome and early recovery (return to baseline     activity). These are measured (captured) utilizing a wearable technology (WT) device.      Return to baseline (RTB) activity for the purpose of this study is defined primarily as step     count normalization as a surrogate of activity (pre versus post operative step count), and     heart rate variability normalization back to preoperative baseline. Increased heart rate     variability has been studied in acute care settings as a marker of poor prognosis. Please     note that return to baseline is not defined for the pediatric population in the same way as     adults (which is primarily questionnaire based and not applicable in children).   "
5208|NCT03217695|"     Mild traumatic brain injury (mTBI), also known as concussion, is of great concern in the     youth population, with incidences of injury steadily increasing within the past few years.     Current Canadian estimates have indicated that the total rate of concussions per 100,000     increased from 467 to 754 for boys and from 209 to 441 for girls from 2003-2010. As defined     by the recent Zurich Consensus statement, concussion is a pathophysiological injury induced     by biomechanical forces, which can be caused by impact to the head, neck or body. In 10-20%     of youth, concussion symptoms persist in the weeks, months or even years following the     injury. Consequently, youth with persistent concussion symptoms are unable to fully     participate in the meaningful activities (e.g. attending school, engaging with friends and     community) they did prior to the injury and experience a reduced quality of life.      Persistent concussion symptoms in youth requires an approach that directly addresses the     rumination and attention to distressful thoughts about their functional performance, while     still promoting appropriate levels of physical and cognitive demands. Targeting these     constructs may shift the focus away from symptoms, while building self-efficacy and enhancing     participation in daily activities. Mindfulness-based yoga (MBY) is a mind-body intervention     that uses physical yoga poses, purposeful breathing techniques and a focus on being in the     present moment. MBY encourages participants to develop moment-to-moment awareness of physical     sensations, emotions, and thoughts, and promotes the cultivation of non-judgemental and     accepting relationships to personal experiences. In chronic pain, fibromyalgia, mental health     and now TBI populations, MBY has demonstrated benefits in physical (i.e. increased muscle     strength, endurance), psychological (i.e. decreased stress, increased self-efficacy),     cognitive (i.e. increased concentration) and social (i.e. emotional regulation, improved     mood) domains. Although mindfulness based yoga has been validated as a form of rehabilitation     in the adult population, its applicability for youth with persistent concussion symptoms has     yet to be explored. Understanding the impact of a MBY intervention on this population may     enhance management of persistent symptoms and ultimately, participation in meaningful     activities.      In addition to the functional sequelae that ensue following this injury, concussion in both     the acute and persistent phases is being recognized as a neurophysiological injury.     Traditional methods of assessment following concussion place emphasis on subjective     self-report and administration of neuropsychological batteries. These assessments are used in     an effort to return the youth to activity (i.e school, sport). However, these methods can be     unreliable as youth have a high incentive to return to play and neurocognitive resolution     does not necessarily equate to pre-injury function. To augment these measures, an objective     indicator of neurophysiological stress is needed. Heart rate variability (HRV) is an     objective, neurophysiological indicator of autonomic nervous system functioning. HRV is     quantified by measuring the time intervals between heartbeats. Increased variability in heart     rate (i.e. increased HRV) is seen as healthy neurophysiological function, demonstrating an     individual's ability to adapt and be flexible to the demands of the environment. Conversely,     decreased HRV is demonstrative of an individual's reduced ability to respond flexibly to     their environment. Investigating the impact of persistent concussion symptoms on HRV has the     potential to enhance our understanding of autonomic nervous system functioning in the chronic     phases of this injury for an understudied population.      The specific objectives are to: (1) adapt the MBY intervention protocol to suit the unique     needs of youth with mTBI (i.e. safety, fatigue), (2) collect data on the impact of MBY on     HRV, self-efficacy and participation, (3) describe changes in HRV, self-efficacy and     participation associated with MBY across pre-intervention, post-intervention and 3 months     following intervention, (4) identify if post concussion symptoms change (i.e. increase or     decrease) following MBY and (5) identify if changes in post concussion symptoms occur with     changes in HRV, self-efficacy and participation.   "
5209|NCT03217682|"     This is a cohort study where subjects will receive either massage therapy or music therapy     interventions to evaluate their impact on hospice patients.   "
5210|NCT03217669|"     This is a small phase I study with dose escalation and dose expansion cohorts. The former     cohort will need up to 12 subjects with advanced solid tumor to define feasibility and     recommended phase 2 dose (RP2D); the latter up to 10 subjects to further define safety. Study     subjects will be adults with advanced solid tumor (dose escalation) and advanced non-small     cell lung cancer (NSCLC) who progressed on at least one first-line systemic therapy (dose     expansion).   "
5227|NCT03217448|"     This is a single-center, prospective, randomized (1:1), open-label study with two parallel     groups. This study is planned to investigate the efficacy and safety of dabigatran etexilate     comparing with warfarin for the treatment of cerebral venous thrombosis.   "
5211|NCT03217656|"     The Jiaxing Birth Cohort (JBC) is the largest prospective cohort study to explore prenatal     risk factors, early life feeding practice and growth pattern/ adiposity in Chinese     children.Between 1999 and 2013, 338 413 mother-child pairs were recruited in Jiaxing area in     south-east China.Children of the recruited women were followed up at 1-2, 3, 6, 9 and 12     months of age, and subsequently followed up every 6 months to 36 months of age (toddler     stage), and every year to 6-7 years of age before they went to school (pre-school stage).     Follow-up rate was 70.8% at the toddler stage and 68.9% at the pre-school stage up to June     2013.   "
5212|NCT03217643|"     It has been recently reported that EATL type 1, but not refractory coeliac disease, strongly     expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the     combination brentuximab vedotin and CHP is known and since the role of etoposide as part of     induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity     of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment     of EATL.   "
5213|NCT03217630|"     This is a prospective cohort study. The main objective is to compare the prevalence of a     full stomach using gastric ultrasound technique, in elective surgical patients with     diabetes mellitus compared to non-diabetic controls following the present fasting guidelines     (2 h after clear liquid and 6h after a light meal). For patients with a full stomach, an     consecutive ultrasound scan is performed every 30 min,until empty stomach or intermediate     stomach contents are detected to determine the mean gastric emptying time for clear liquid     and light meal, and to investigate the risk factors for delayed stomach emptying in diabetic     patients by logistic regression analysis .   "
5214|NCT03217617|"     This is a Phase I/II clinical trial of gene therapy for X-linked severe combined     immunodeficiency (SCID-X1) using a self lentiviral vector to replace the defective genes with     good genes. The primary objectives are to evaluate the safety and efficacy of the ex vivo     gene therapy clinical protocol.   "
5215|NCT03217604|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     single ascending doses of PF-06852231 after first-time administration to healthy adult     subjects. The safety, tolerability, and pharmacokinetics of an active metabolite     (PF-06892787) will also be evaluated in this study.   "
5216|NCT03217591|"     To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with     albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.   "
5318|NCT03216265|"     The objective of this POC clinical study is to investigate the impact of the test product     (Developmental Cosmetic Moisturising Cream) on skin barrier function and skin moisturisation     on the forearm and face after 4 weeks of twice daily application compared to no treatment in     participants with dry sensitive skin.   "
5217|NCT03217578|"     Parents or legal guardian of neonates who signed agreement will receive SMA screening test if     their neonates are affected with SMA. The dried blood spots of routine newborn screening     samples will be used to test if neonates have lost 2 copies of SMN1 gene. If neonates have     positive SMA screening test, further confirmation with multiplex ligation-dependent probe     amplification (MLPA) test and prospective motor function monitoring including physical and     neurological examinations will be proved to make SMA confirmation. For any confirmed SMA     patient, genetic counseling and standard of care will be proved.   "
5218|NCT03217565|"     The primary objectives of this study are to describe the single-dose pharmacokinetics (PK) of     intravenous (IV) tedizolid phosphate or an oral suspension of tedizolid phosphate, when     administered to pediatric participants, full-term neonates, and preterm neonates.   "
5219|NCT03217552|"     This study is a prospective, single center, observational, cohort study of patients to     determine whether the Mologic Biomarker Panel can identify patients with infection from those     without, including those with other reasons for inflammation (e.g. post-operative). It will     also assess whether it has the potential to judge the severity of illness, prognosticate     outcome and guide antibiotic therapy.      The aim is to recruit patients who are representative of patients with suspected sepsis,     uncomplicated infection, or non-infection related critical illness that require critical care     intervention and assessment.      This study is observational and will not alter patient management or the standard of care.     The results from the investigational Mologic Biomarker Panel and associated research assays     will not be provided to treating clinicians, or used in any manner to affect patient care.      The study will take place over approximately an 18-month period and it is anticipated that     approximately 600 patients will be collectively enrolled. The study aims to recruit patients     from three environments within UCLH:        -  The Emergency Department.        -  Critical Care Unit        -  Patients undergoing major surgery   "
5220|NCT03217539|"     Population-based randomized controlled trial carried out in two Swedish counties, Dalarna and     Ostergotland to find out the impact of early detection on mortality from breast cancer.   "
5221|NCT03217526|"     Twenty-four individuals with burn injury will be included in this study. Participants with     burn injury will evaluate with the following assessment tools: Demographic datas; age,     gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn     injury, localization of burn injury and total burn surface area will be recorded. Gait     parameters (step length, stride length, base support, step time, cycle time, cadence,     velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait     cycle). will be recorded via GAITRite system.   "
5222|NCT03217513|"     The purpose of this study is to generate proof of concept human data by evaluating     osteoarthritis outcome measures in arthritic patients that are prescribed Forteo® as the     standard of care to treat their primary diagnosis of osteoporosis.   "
5223|NCT03217500|"     The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial     autograft is more effective than limbal conjunctival autograft for ocular surface     reconstruction after excision of pterygium.   "
5224|NCT03217487|"     The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial     autograft is more effective than limbal conjunctival autograft for ocular surface     reconstruction in patients with limbal stem cell deficiency (LSCD).   "
5225|NCT03217474|"     The purpose of the study is to learn if adding femtosecond laser-assisted corneal debridement     to a standard therapy of oral ganciclovir can help shorten the healing time of herpes simplex     epithelial keratitis (HSK).   "
5231|NCT03217396|"     A prospective and retrospective cohort study of about five years will be performed on blood     and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within     the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as     Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD),     and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical     reasons will be recruited As control groups.   "
5232|NCT03217383|"     Obstructive sleep apnea (OSA) is a common disease that is largely un-diagnosed and untreated.     Standard treatment for obstructive sleep apnea, nasal continuous positive airway pressure     (CPAP), entails use of a nose mask to deliver positive pressure which dilates the pharynx and     eliminates obstruction. This therapy is highly efficacious and benign but is associated with     low adherence, particularly in non-sleepy apneics with disease of mild and moderate severity.     The principal alternative to CPAP therapy is oral appliance (OA) therapy in which a custom     made mandibular advancement splint (MAS) is used to protrude the mandible during sleep,     thereby opening the pharyngeal airway. OA therapy, while preferred and well accepted by most     participants, is not uniformly efficacious. Additionally, uncertainty regarding the patient's     response to OAT and the effective target mandibular position can lead to a significant time     span between diagnosis and initiation of effective treatment. Furthermore, knowledge of the     effective target mandibular position supports the use of new OA design and manufacturing     processes that can further reduce the time and cost in delivering the therapy.      Zephyr Sleep Technologies (the Sponsor) has developed a method of identifying OAT responsive     participants and their efficacious mandibular protrusion. Recently, Zephyr Sleep Technologies     developed a portable device that avoids this requirement and can be used in a multi-night     test in the home. Using a feedback controlled mandibular positioner (FCMP), the device     measures and analyzes respiratory airflow and oxygen saturation and makes decisions in     real-time about moving the mandible. The FCMP device was tested in a blinded, bi-phase     clinical study in which participants with mild-to-severe sleep apnea (n=202) underwent two     full-night studies in the home. Data from phase 1 were used to develop a predictive method,     and data from phase 2 were used to prospectively test the accuracy of the predictive method.     An efficacious mandibular position was also predicted, and each participant was treated with     a custom oral appliance set to that position. Data from both phases were used to evaluate the     feasibility of use of the device in the home.      A random forest machine learning system was used to develop and test the predictive method.     The overall oral appliance success rate was 76% for phase 1 and 71% for phase 2. The overall     predictive accuracy was 88%. Values for sensitivity and specificity were 85% and 93%,     respectively. Positive and negative predictive values were 97% and 72%, respectively. The     effective target protrusive position was identified in 86% of cases. The studies were     conducted independently by the participants in their homes, though due to limitations in the     early prototype design, a clinical coordinator visited the home to set up the equipment prior     to each night of study. No significant problems were encountered, and no significant risks     were identified. The results of the clinical trial show that the auto-titrating mandibular     positioner is suitable for use in the home and accurately predicts OAT outcome as well as     target protrusive position.      Based on the results of this study, Zephyr developed a commercially available device which     has been approved for sale in Canada (Health Canada device license #97614). The device,     branded MATRx plus, functions as both a sleep recorder as well as a home-based system to     select patients for oral appliance therapy. This commercially available device is currently     being used in three separate usability trials to quantify the usability of the device and the     benefits of an improved workflow through adoption of the new technology in a dental practice.      Evidence has recently appeared to indicate that the change in pharyngeal volume caused by     protrusion of the mandible, measured while awake, correlates with the change in     apnea-hypopnea index (AHI) achieved by OAT, measured while asleep. This is the first     convincing evidence that an awake measurement of the pharyngeal airway correlates with the     improvement in respiratory status during sleep induced by an oral appliance. The implication     is that a simple conebeam CT of the pharynx can predict outcome with OAT. Accordingly, we     shall carry out conebeam CTs in the research protocol, both at rest position of the mandible     and at 90% of maximal protrusion.      The purpose of this study is to test whether the predictive accuracy of the FCMP in the home     environment is improved by the commercial design and whether patients predicted to be     suitable for oral appliance therapy have long term adherence.   "
5233|NCT03217370|"     The investigators noticed a variable prescription of blood components to haematological     patients in the hospital. This study will analyze the prescription and administration of     blood components to Haematological patients (pre measurement). Based on these results     guidelines on transfusion triggers will be updated and educated to the physicians and new ICT     (information and communications technology) implementations will be added to the electronic     order for blood components. The investigators hope to see afterwards (post measurement) a     more stable prescription and administration of blood components and a more economic use of     blood components.   "
5430|NCT03214796|"     The aim of this study is to investigate the effect of albumin infusion on oxidative albumin     modification, on plasma thiol status and on albumin binding capacity for DS in patients who     routinely receive albumin infusion for various indications and to relate these findings with     neurohumoral parameters, bacterial products such as endotoxin, and neutrophil function   "
5234|NCT03217357|"     An exacerbated response to stress mediated by activation of the     Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the     onset, worsening and relapse of schizophrenia. Subjects at risk for schizophrenia (unaffected     siblings of patients) displayed an intermediate hyperreactivity to stress as compared with     patients and healthy controls.      Symptoms of schizophrenia can be reduced with noninvasive brain stimulation (NIBS) applied     over the dorsolateral prefrontal cortex (DLPFC). Importantly, this same DLPFC NIBS protocol     can modulate decision making processes and modulate biological reactivity to stress by     decreasing salivary cortisol concentration in acute stress condition.   "
5235|NCT03217344|"     Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be     treated non-operatively. The question remains on how long do we have to immobilize     non-operatively treated proximal humeral fractures?   "
5236|NCT03217331|"     This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess     safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an     LVAD.   "
5237|NCT03217318|"     After providing informed consent, patients will be randomized into one of two groups     (single-blinded): Group 1 will receive a standard Percuflex® (Boston scientific) ureteral     stent. Diameter: 6F, length according to surgeons' estimation. Patients in Group 2 will     receive a Suture-Stent adjusted to the individual stone location.      All participant receive standardized patient information, using a validated leaflet on     ureteral stenting and associated morbidity.      In both groups, patients will complete the Ureteral Stent Symptoms Questionnaire (USSQ) 1     week after stent insertion, prior to stent removal (i.e. 2-6 weeks after insertion) and after     (2-6 weeks) stent removal. USSQ results after stent removal serve as an assessment of     baseline symptoms. During secondary stone removal, stents are removed and ureteral     dilatation / access is assessed.      The removed stents will be assessed for biofilm formation within the framework of an approved     and ongoing study on the development of a Biofilm-model (EKSG 15/084). Potential     complications and adverse events are assessed at all scheduled and unscheduled patient     visits.   "
5238|NCT03217305|"     The study compares two different ventilation modes, Pressure support ventilation vs.     Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest     is shunt and alveolar deadspace and ventral vs. dorsal ventilation.   "
5239|NCT03217292|"     Analgesia following video-assisted thoracoscopic surgery (VATS) is important for the     prevention of postoperative pulmonary complications.Various regional methods of anesthesia     are currently being used to achieve this goal. The aim of the study was to assess the     effectiveness of SAPB on postoperative VATS analgesia.   "
5240|NCT03217279|"     The incidence of Stroke in France is about 150 000 per year. Stroke represents the leading     cause of long-term disability. The specificity of stroke is the sequelae polymorphism that     can occurs: physical disability, cognitive deficit and sensitive trouble. Then this large     extend of sequelae may have a different impact on daily life. Therefore, we have to consider     the individual's own resources and in his whole environment to face the situation. We suppose     that each situation, each post-stroke disability will have a different social impact in     stroke survivors and their caregivers. Nowadays, Barthel Index and Rankin scale are the     standards for the assessment of the stroke impact on survivors' daily life. However, what is     the real impact of an activity limitation in daily life? How consider the psychosocial impact     of stroke only with functional indicators? For this study we will consider handicap and     disability in a societal way. In fact, the WHO developed in 2001 the International     Classification of functioning, disability and health that allows to bring the concept of     participation restriction, this is to say the consequences of a disability in the real life.     The ICF allows to bring a conceptual framework of participation restriction.      Psychosocial consequences of stroke are relatively unknown especially in France. According to     our hypothesis, patients with major disabilities and their caregivers will experience more     psychosocial consequences and participation restriction in terms of emotional health, quality     of life and burden. Also, we hypothesize that stroke severity, the typology of disabilities     (motor, cognitive and sensorial) will have a different impact on patients and proxys' lifes     in terms of psychosocial consequences, participation restriction and quality of life.      TYBRA study is a prospective multicentric cohort study that mixes qualitative and     quantitative approaches. The first aim of the quantitative approach is to explore factors     related to patients and their caregivers at 6 months that predict participation restriction     at 12 months post-stroke. The first aim of the qualitative study is to explore the experience     of stroke in minor stroke patients and their proxys.   "
5241|NCT03217266|"     This phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 and radiation therapy     in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Giving MDM2 inhibitor     AMG-232 and radiation therapy before surgery may make the tumor smaller and reduce the amount     of normal tissue that needs to be removed.   "
5242|NCT03217253|"     This phase I trial studies the best dose and side effect of tazemetostat in treating patients     with solid tumors or B-cell lymphomas with liver dysfunction that have spread to other places     in the body or cannot be removed by surgery. Tazemetostat may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth.   "
5253|NCT03217110|"     The purpose of this study is to examine whether cerebellar stimulation can be used to improve     cognitive deficits and mood in patients with schizophrenia, autism, bipolar disorder,     Parkinson's disease, and major depression.   "
12396|NCT03123354|"     The study will collect cerebral oximetry data from pediatric and neonatal subjects using the     Masimo O3 regional oximetry device, for the purposes of device calibration and validation.   "
5243|NCT03217240|"     Advances in paediatric cardiology and cardiac surgery have enabled the survival of most     patients born with congenital heart disease (CHD) into adulthood. Many CHD patients have     undergone palliative or reparative surgery earlier in life. As patients survive into     adulthood, they may need intervention or surgery for residual haemodynamic lesions. This is     because they are at risk of arrhythmias secondary to structure heart disease and are     susceptible to acquired heart disease. In these patients, pre-operative and post-operative     evaluation of right ventricular (RV) structure (shape and volume) and function is an     essential component of clinical management.      Advances have been made in cardiac imaging so that accurate assessment of the right heart     chamber in terms of its structure, function and physiology is possible. However, this     technology has as yet never been applied in an effort to comprehensively assess RV structure,     function and physiology. Cardiac Magnetic Resonance (CMR) will be used in this comprehensive     assessment of structure and function. Thus, this research will allow development of a     comprehensive integrated biomedical engineering (BME) R&D platform for in-depth study and     clinical diagnosis of the RV structure-function relationship and physiology and its     association with biomarker, and exercise capacity in CHD.   "
5275|NCT03216824|"     Central venous access device (CVAD)-associated skin impairment (CASI) is a common problem in     allogeneic hematopoietic stem cell transplant (HSCT) recipients. In this prospective     randomized pilot study, dressing the CVAD exit site will be compared to no-dressing with     respect to CASI and CVAD-related bloodstream infection (CRBSI) rates in adult outpatient HSCT     recipients. The purpose of this study is to gain information that can be used to design a     large randomized controlled trial (RCT).   "
5431|NCT03214783|"     The purpose of this study is to explore the facial characteristics asscosiated with the     increased risk of coronary artery diseases. The secondary purpose is to evaluate the     diagnostic efficacy of appearance factors for coronary artery diseases.   "
5244|NCT03217227|"     Ischemic Heart Disease (IHD) is a condition of recurring chest pain or discomfort that occurs     when a part of the heart is not receiving sufficient blood flow. It is a major public health     concern internationally and in Singapore, the leading cause of death from cardiovascular     disease. Cardiovascular magnetic resonance (CMR) has the ability to assess heart structures,     scarring or lack of blood supply to the heart muscle with great accuracy and without any     radiation involved. A CMR-compatible cycle ergometer can offer a safe and low cost stress     equipment to assess heart function and motion abnormalities, and restrictions of the blood     supply to the heart tissues due to partial or complete blockages of the blood vessels. This     study aims (1) to develop an exercise-CMR stress protocol by testing its feasibility and     robustness in assessing changes in cardiac volumes and function due to physical exertion in     healthy individuals and (2) to assess the accuracy of the multiparametric stress-CMR as a     diagnostic tool for ischemic-causing coronary artery disease (CAD) with coronary fractional     flow reserve (FFR) as a reference.   "
5245|NCT03217214|"     In the proposed method of sensing the vital health sign related to CVDs, thermal heat     transfer performance of the skin will be evaluated using a non-contact based IR temperature     sensor. The temperature of the skin is significantly dependent upon the heat source as blood     vessels (veins and capillaries) in the vicinity of the skin. However, there are several     locations in the human body, where arteries are also at a relatively less depth from the     outer skin surface (radial or ulnar arteries at the wrist and carotid artery in the neck). If     it is possible to track the flow of blood from the thermal performance of the skin, then it     could be useful in predicting various states of the human health related to cardiovascular     activities.      Subjects will undergo Existing Procedure EP- Passive Thermography PT for Phase I and Existing     Procedure EP- Active Thermography ATLIC/ATPC for Phase II, with Duplex Ultrasound being the     existing procedure that is considered as more reliable in clinical practice. Existing Passive     Thermography will be used to setup the baseline data for Phase I. The currently     under-development temperature mapping method (Active Thermography) that involves application     of cooling (either pulsed or lock-in cooling) over the skin will be utilized for Phase II.   "
5246|NCT03217201|"     Cancer related fatigue (CRF) is a stressful and constant tiredness related to cancer and/or     its treatment. CRF is the most intense during treatment and can severely interfere with     activities of daily living, such as tasks that require physical strength or thinking clearly.     Prevalence of CRF has been reported to be as high as 94% during chemotherapy and as high as     34% five years after completion of treatment (Rotonda et al. 2013; Minton & Stone 2008).     There is currently no generally-accepted treatment for CRF. However, there is evidence to     suggest that light therapy can help with CRF. Non-pharmacological interventions for CRF have     also been studied but are costly to implement and involve significant patient burden,     particularly among those in active treatment. Given the clinical impact of CRF, the goal of     this project is to investigate a novel, low-cost and low-burden intervention for Breast     Cancer patients using a particular kind of light treatment called systematic light exposure     (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant     or neoadjuvant chemotherapy will be recruited from Mount Sinai Medical Center and Memorial     Sloan Kettering Cancer Center. The light will be administered by a small, personal Litebox     daily throughout entire duration of chemotherapy. Outcomes will be assessed at eight     timepoints during chemo, and a series of follow up assessments at 1 week, 1-month, 3-months     and 6-months post-chemotherapy. This study will have major public health relevance as it will     determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively     reduces CRF or prevents it from worsening during chemotherapy. Specific Aims: Aim 1:     Determine if sLE prevents CRF from worsening in BC patients undergoing chemotherapy Aim 2:     Determine whether sLE affects sleep, depression and circadian activity rhythms. Exploratory     Aim 3: Investigate sLE normalizes circadian cortisol rhythms. Exploratory Aim 4: Examine     whether the effects of sLE on fatigue are moderated/mediated by sleep quality, depression,     and/or circadian rhythms.   "
5247|NCT03217188|"     The purpose of this study is to evaluate the tumor control and the side effects of using     proton therapy for head and neck cancer that has come back.   "
5248|NCT03217175|"     The study will consist of two study arms. Each arm will include a 24-96 hour outpatient     run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas. In     random order subjects will then complete two approximately 5-hour exercise visits, one     wearing the bi-hormonal bionic pancreas and one wearing the insulin-only bionic pancreas.   "
5249|NCT03217162|"     Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of     surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit     from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any     potential risk factors related to mortality.   "
5250|NCT03217149|"     Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox     is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox     when oxygenation deteriorated on mechanical ventilation and to identify any potential risk     factors related to mortality.   "
5305|NCT03216434|"     This research study is being done to try to find a way to accurately diagnose post-traumatic     stress syndrome (PTSD) in combat veterans.Diagnostic biomarkers have made invaluable     contributions to the diagnosis and treatment monitoring of many diseases and disorders.     Unfortunately, PTSD currently lacks a reliable and compelling clinically-relevant biomarker.     The absence of a viable biomarker impairs efficient and confident diagnosis of PTSD, with     diminished effective care options often resulting.   "
5254|NCT03217097|"     Neuroendocrine tumors (NET) are rare but their incidence is growing. Alkylating agents (ALKY)     are one of the main systemic treatments used, at least for advanced pancreatic NETs, with a     response rate of 30 to 40% and a median progression-free survival of 4 to 18 months.     Chemotherapy is one of the few therapeutic weapons, along with everolimus, somatostatin     analogs, and metabolic radiotherapy, for pulmonary NETs, called typical and atypical     carcinoids, even if the level of proof of efficacy for these treatments is lower than for     pancreatic NETs. Considering the available retrospective data, O6-Methylguanine-DNA     methyltransferase (MGMT) appears to be a predictive factor of the response to ALKY.     Oxaliplatin (OX) has demonstrated an interesting activity, with response rates between 17%     and 30%. In a first retrospective study we showed that Gemox is effective in NET, and more     recently that its activity is similar to that of ALKYs, but without being influenced by the     MGMT status. Prospective studies are needed but our data suggests that ALKY should be offered     first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be     offered first to patients with unmethylated MGMT tumors. In this project, we wish to evaluate     the contribution of the MGMT methylation, evaluated in the tumor, in predicting the Objective     Response (OR) in patients treated with ALKY and to carry out the first randomized phase II     study comparing a treatment with alkylating agents to Oxaliplatin in patients with a     pancreatic or broncho-pulmonary NET.      The main objective of this study is to evaluate the usefulness of tumor MGMT methylation in     the prediction of the Objective Response (OR) at 3 months in patients treated with ALKY for a     NET, assessed using the RECIST v1.1 criteria by centralized reading carried out by an expert     radiologist blinded to the results of the MGMT methylation.   "
5255|NCT03217084|"     Dental caries is the destruction of the tooth structure in the presence of organic acids     produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and     Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH)     2), which is subjected to consecutive cycles of demineralization and remineralization. This     is an interrupted process, with periods of remineralization and demineralization occurring,     depending on the state of the oral environment in terms of the prolonged accumulation and     retention of bacterial plaque on the enamel surface (Aoba, 2004).      Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the     subsurface dissolution of the hydroxyapatite crystals. Under normal physiological conditions     (pH7), saliva is supersaturated with calcium and phosphate ions which diffuse into the     vacancies created during acid-mediated demineralization episodes (Dowker et al., 1999 and     Robinson et al., 2000). The demineralization of enamel (white spot lesions) is a significant     problem during and after orthodontic treatment with prevalence 71.1% and various preventive     measures have been suggested to minimize the incidence (Derks et al., 2004 and Al Maaitah et     al., 2011).   "
5256|NCT03217071|"     This is a randomized single-institution, phase II, open-label clinical trial of neoadjuvant     pembrolizumab with or without low-dose stereotactic radiation therapy (SRT) in stage I-IIIA     non-small lung cancer (NSCLC) patients who are planned to undergo surgical resection of their     lung cancer.   "
5257|NCT03217058|"     Substance use disorders (SUDs) and depression in HIV-infected patients result in poor HIV     outcomes, yet are often unrecognized and untreated. To address these problems, this study     examines the implementation and effectiveness of a clinical intervention consisting of     self-administered tablet-based SUD and depression screening at routine HIV primary care     clinic visits, followed by evidence-based treatments for SUD and depression delivered by a     behavioral health specialist. If successful, this study has potential to reduce SUD- and     depression-related problems and reduce HIV treatment disparities for patients with these     comorbidities.   "
5258|NCT03217045|"     Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the     first weeks of life is responsible for postnatal growth restriction and adverse long-term     outcomes.      This study aimed at evaluating the impact of the introduction of an updated, standardized,     nutrition protocol on very premature infants' growth and morbidity, and the care givers'     compliance to the new protocol.   "
5259|NCT03217032|"     This study is a Phase I/II trial using a novel bioengineered lenti viral vector to deliver a     normal gene for human clotting factor VIII or factor IX into patients with hemophilia A or     hemophilia B, to evaluate the safety, efficacy and pharmacokinetics of IV infusion of gene     modified autoHST in patients.   "
5260|NCT03217019|"     In neonate and infant, radial artery cannulation may be challenging and multiple attempts are     required because of the small diameter.      The invastigators will compare the success rates of radial arterial cannulation with a     guidewire-assisted technique and the direct technique in pediatric patient(<1yr).   "
5261|NCT03217006|"     The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent     coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a     single arterial graft is associated with a reduction in the composite outcome of death from     any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.     The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG,     the use of two or more arterial grafts compared to a single arterial graft is associated with     improved survival.      Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects     enrolled in at least 25 international centers. Patients will be randomized to a single     arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1     fashion between the two groups. Permuted block randomization with random blocks stratified by     the center and the type of second arterial graft will be used to provide treatment     distribution in equal proportion.   "
5262|NCT03216993|"     compare different enteral nutrition strategy in patients with mechanical ventilation   "
5263|NCT03216980|"     Specific Aim #1: Examining the impact of posttraumatic stress disorder (PTSD) on peripheral     vascular function and sympathetic nervous system activity in young individuals.      Specific Aim #2: Examining the impact of posttraumatic stress disorder (PTSD) on peripheral     hemodynamics and metabolic byproducts during small muscle mass exercise in young individuals.      Specific Aim #3: Examining the impact of posttraumatic stress disorder (PTSD) on exercise     tolerance, peripheral hemodynamics and metabolic byproducts during large muscle mass exercise     in young individuals.   "
6252|NCT03204032|"     A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and     safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and     Thalidomide in subjects with Advanced Extrapancreatic Neuroendocrine Tumor   "
5288|NCT03216655|"     Nowadays, doctors put mental health at a prior place and pay more attention to the     psychological problems of ill kids' parents. In our research, we try to find a new modern and     efficient psychological counseling mode to improve the mentality of parents and relieve their     anxiety and depression. We divide guardians of parents into two groups .One group is given     the traditional follow-up by regular phone call every month. The other is in a wechat group.     A doctor send the useful information about kids care and answer questions of parents at     regular time every month. The self-rating anxiety scale (SAS) and self-rating depression     scale (SDS) scores of parents are marked before and after the long follow up.   "
5264|NCT03216967|"     BK virus nephropathy (BKVN), a consequence of the strong immunosuppressive therapy given     after kidney transplantation, represents a growing problem in the kidney transplant (KT)     setting. In recent cohorts, BKVN concerns up to 10% of kidney transplant recipients and early     signs of BK virus (BKV) infection as development of asymptomatic viruria and viremia are even     much more frequent (40% and 20% of patients, respectively). In this context, finding     strategies to prevent BKV infection or treat patients before the occurrence of BKV     nephropathy is challenging. For several years, detection of BKV replication by real-time PCR     in urine and/or blood of kidney transplant recipients at early stages of infection allowed     adaptation of their therapy. As BKV reactivates essentially in patients with     over-immunosuppression, the first step of the treatment is the reduction of     immunosuppression. However, reducing immunosuppression (IS) can lead to acute rejection and     allograft loss. Other treatments have been proposed (cidofovir, quinolones) but their     toxicity profile or their lack of clinical efficacy are now demonstrated. Hence, an efficient     and safe strategy against uncontrolled BKV replication is urgently needed. MTor-inhibitors     are well known immunosuppressive drugs used in organ transplantation to prevent     graft-rejection. They have furthermore anti-viral effects that can be beneficial for     prevention of viral infections after transplantation. Recent evidence that inhibition of mTor     pathway had an impact on BK infected cells provides additional insight into the observed     benefits associated with these drugs. The aim of our study is to evaluate the effect of the     mTor inhibitor everolimus on the prevention of severe BKV infection (BKV nephropathy or loss     of the allograft) after kidney transplantation compared to the reduction of immunosuppression     alone in kidney recipients with BK viremia.   "
5265|NCT03216954|"     This study will evaluate the behavioral effects of alcohol during placebo and     n-acetylcysteine maintenance using sophisticated human laboratory methods.   "
5266|NCT03216941|"     comparison of intramuscular olanzapine and ketamine efficacy as first medication for fast     sedation of patients with agitation and aggressive behavior. Five hundred patients with     agitation caused by psychiatric disorder were randomly assigned under double-blind conditions     to receive olanzapine or ketiapine. The Overt Agitation Severity Scale, Overt Aggression     Scale and Ramsay Sedation Scale will be applied within 12 hours after the first dosage.   "
5267|NCT03216928|"     Blood test in Rheumatoid Arthritis (RA) patients with good response to anti-Tumor Necrosis     Factor (anti-TNF) and in patients with moderate or non-response will be done in the month     following the evaluation of clinical response to therapy. Isolation of mononuclear cells and     purification of monocyte by negative selection. Cell culture of monocyte in presence or not     of anti-TNF for 24 hours and analyze of CD36 (cluster of differentiation antigen 36)     expression (principal outcome). For secondary outcomes analyze monocyte phenotype, NRF2     nuclear translocation, and clinical data of patients.   "
5268|NCT03216915|"     The current study sought to prolong the observational interval after initiating medication     with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an     indicator of autonomic nervous system function in patients with RR-MS.   "
5269|NCT03216902|"     Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop     medications has been shown to be effective in delaying or preventing the progression of     glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field     loss.      This study is being conducted to determine how well DE-126 ophthalmic solution works     (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate     the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost     (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.      The IOP will be measured at 3 different times throughout the day, over 6 total visits during     a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop     taking current eye drops to lower IOP). Safety assessments will be done throughout the study,     including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the     most important time-point to measure IOP in this study and evaluate efficacy will be at the     final study visit (month 3), IOP values will also be evaluated at other visits throughout the     3-month treatment period.   "
5270|NCT03216889|"     The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I)     will improve sleep quality, fatigue, and quality of life in individuals with multiple     sclerosis (MS) with symptoms of insomnia.   "
5271|NCT03216876|"     This is an open-label, active treatment trial to determine the pharmacokinetics of orally     administered ursolic acid and to assess the potential efficacy and safety of ursolic acid in     subjects with primary sclerosing cholangitis (PSC).   "
5272|NCT03216863|"     The feasibility and impact of respiratory rehabilitation (RR) in patients with advanced or     metastatic (EGF-R WT or mutated) non-small cell lung cancer treated with oral targeted     therapy including Inhibitors of EGF-R tyrosine kinases (TKI) and ALK inhibitors.      These patients will benefit, at the beginning of the chemotherapy whatever the treatment     line, of a respiratory rehabilitation. The respiratory rehabilitation takes place at the     patient's home with the HAD's cooperation 3 hours per week, divided into 2 or 3 sessions.     There is associated educational, nutritional and psychological support for a total duration     of 8 weeks.   "
5273|NCT03216850|"     Characterisation of the lipidome and parenteral nutrition modulate the endothelial     glycocalyx.      The aim of the study A is to detect any influence of the lipid emulsion on the endothelial     glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an     indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be     enrolled.      Monitored variables: demographic data, type of the population, type of the lipid emulsion,     selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),   "
5303|NCT03216460|"     Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and     insulin data will be collected. Subjects or their caregivers will manage their diabetes at     home per their usual routine using the study CGM and remain on current MDI or pump therapy.     This will be followed by a 5-day/4-night, hybrid closed-loop phase conducted in a supervised     hotel/rental house setting.   "
5306|NCT03216421|"     The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal     Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and     patient-related impact of adopting IORT.   "
5274|NCT03216837|"     Perinatal stroke causes lifelong neurological disability and most hemiparetic cerebral palsy     (CP). With morbidity spanning diverse aspects of a child's life and lasting for decades,     global impact is large, including 10000 Canadian children. With pathophysiology poorly     understood and prevention strategies non-existent, the burden of hemiparetic CP will persist.     Limited treatments lead to loss of hope for children and families, necessitating exploration     of new therapies. The investigators have evidence that the investigators have a durable new     treatment for perinatal stroke, combining non-invasive neurostimulation and child-centred     intensive rehabilitation. Via the CHILD-BRIGHT SPOR national network, the investigators will     execute a multicentre trial to prove this treatment can improve function in children with     perinatal stroke and hemiparetic CP. Using novel advanced technologies not available     elsewhere in the world, the investigators will explore how developmental plasticity     determines function and response to neuromodulation therapy. This patient oriented effort     will advance personalized, precision medicine in pediatric neurorehabilitation to improve     outcomes for disabled children and their families.   "
5289|NCT03216642|"     An observational study was designed to research the bacteriology and pathogen drug     sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.   "
5276|NCT03216811|"     Nutraceuticals have attracted interest as possible approach to be associated with lifestyle     changes for lowering plasma cholesterol levels in patients with moderate     hypercholesterolemia. Ruscica and colleagues showed that a 8-weeks treatment with a     nutraceutical combination containing red yeast rice extract, berberine, policosanol,     astaxanthin, coenzyme Q10, and folic acid was able to reduce significantly total cholesterol     (−12.8%) and low-density lipoprotein-cholesterol (−21.1%) [11]. These nutraceutical compounds     exert their lipid-lowering effect through different ways, like the inhibition of the     hydroxymethylglutaryl coenzyme A (CoA) enzyme, increasing the hepatic expression of low     density lipoprotein (LDL) receptor and the LDL degradation via enhanced hepatic binding and     internalization. In addition, they up regulate the numbers and function of circulating     endothelial progenitor cells increasing nitric oxide (NO) production. The purpose of the     present study was to assess the effectiveness of CARDIOVIS COLESTEROLO 3 mg (containing red     rice fermented with Monascus purpureus titrated with 3% monacolin K, hydrol mixture of olive     fruit titrated with vitamin E, Coenzyme Q10 and polymethoxyflavones) in terms of cholesterol,     endothelial and inflammatory parameters reduction.   "
5277|NCT03216798|"     This study will investigate preferences for HIV care among participants enrolled in the     Study to evaluate the feasibility of Community-based Test and Treat strategies among men who     have sex with men and transgender women to increase the uptake of HIV testing and treatment     services in Thailand through a model involving linked strategies: The study takes place in     four provinces at six sites affiliated with the Thai Red Cross AIDS Research Center (TRCARC):     Bangkok (RSAT and SWING), Chiang Mai (CAREMAT), Chonburi (SWING and Sisters) and Songkhla     (RSAT). These are all community-based drop-in centers, targeting MSM and TGW.      Participants who are enrolled in the study at any of the TRCARC affiliated sites and who were     tested HIV-positive will be invited to participate in the current questionnaire study.   "
5278|NCT03216785|"     Prospective registry of patients admitted to the medical intensive care unit Patients     discharged are followed up to 5 years after discharge   "
5279|NCT03216772|"     The study is designed to evaluate the safety of performing in-bag morcellation of uterus     tissues during laparoscopic hysterectomy (LSH or TLH). Pre- and perimenopausal women, aged     35-50 undergoing laparoscopic supracervical hysterectomy (LSH) or total laparoscopic     hysterectomy (TLH)   "
5280|NCT03216759|"     To investigate the morbidity of intestinal injury after open surgery and observe the effect     of comprehensive intestinal protection strategy on postoperative intestinal complications in     patients undergoing laparotomy with general anesthesia.   "
5281|NCT03216746|"     Adolescence is a phase of important redefinitions and become an important period in the     construction of new habits. Therefore, oral health education becomes strongly necessary,     since good habits acquired at this stage may be perpetuated for adult life. The aim of this     study is to evaluate the influence of an educational protocol on oral health in oral     knowledge and clinical conditions in adolescence. A longitudinal study is being conducted     with an initial sample of 291 adolescents enrolled in a public school in the city of     Curitiba, Paraná, Brazil. The educational protocol was built in four phases. In phase I, the     participants answered a questionnaire (pre-test) that included five statements about     periodontal diseases and their forms of prevention. The answers were arranged in a Likert     scale with a score of 1 (one) for the correct responses and 0 (zero) for the incorrect ones,     obtaining, therefore, the knowledge score (KC). At this stage, adolescents is also being     clinically assessed using simplified oral hygiene index (IHO-S) for dental plaque evaluation     and gingival bleeding (ISG). In phase II, the sample (n = 291) is being randomly divided into     two groups that receive two different educational interventions: oral orientation (OR) and     video (VD). After each intervention, the questionnaire (post-test) is being reapplied. In the     next phase (III), the study population (n = 291) is being again divided into four groups, and     for two of them (OR + APP / VD + APP) a smartphone app was developed to messages which are     being sending over a period of 30 days. In phase IV, the participants (n = 263) are answering     again to the questionnaire (follow-up test) and are being reassessed clinically.     Non-parametric tests and univariate and multivariate Poisson regression with robust variance     will be used for statistical analysis (α = 0.05).   "
5282|NCT03216733|"     The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is     to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of     unselected patients with ischemic heart disease, using registry detection of clinically     driven events.   "
5414|NCT03215004|"     Clinical specimens are required from HIV positive individuals with viremia controlled by     antiretroviral therapy to complete process development for a genetically modified autologous     T cell product, AGT103-T. The product will be used in a subsequent early stage clinical trial     in subjects with chronic HIV disease and viremia suppressed by antiretroviral therapy as the     initial step in testing a functional cure for HIV disease. Enrolled participants provide a     venous blood specimen (approximately 25mL) to determine their level of HIV-reactive CD4+ T     cells. Subjects with positive T cell responses will be asked to undergo leukapheresis and     their clinical specimens will be used to validate and qualify the AGT103-T cell product.   "
5283|NCT03216720|"     Rationale:      Contemporary coronary artery bypass grafting (CABG) continues to be associated with a     significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal     circulation (miECC) significantly reduces the risk of postoperative bleeding but the     underlying mechanisms are poorly understood.      Primary Objective:      To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on     thrombin generation as indicator of the overall haemostatic capacity after CABG.      Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and     transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution     and haemolysis, endorgan protection, seasibility and safety      Study design:      Single-center, double-blind, parallel-group randomized controlled trial      Study population:      60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive     either miECC or cECC   "
5285|NCT03216694|"     A retrospective hospital-based cohort study of the association between preoperative     cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity     following oesophagectomy.   "
5290|NCT03216629|"     Use of dressing is common place following surgery, allowing for wounds to be covered and     protected. Dressing material with adhesive contact layers or adhesive tape is integral to     sealing off the wound. Mechanical stripping of stratum corneum during dressing removal causes     pain and discomfort. During dressing removal, practitioners may at times apologize as a     function of empathy. Previous study investigated speed of dressing removal and its effect on     discomfort during dressing change. In this study, we aim to investigate how empathy expressed     in form of saying sorry affect the perception of pain during dressing change?   "
5291|NCT03216616|"     Fatigue is common and debilitating in rheumatic inflammatory diseases as for other chronical     medical conditions. The purpose of this study is to develope and evaluate a cognitive     behavioural intervention targeting fatigue. The aim of the intervention is to improve fatigue     self-management by changing behavioral and cognitive factors contributing to perceived     fatigue. Levels of fatigue, depressive symptoms and self esteem will be measured before,     after and three months after the intervention.   "
5292|NCT03216603|"     Health literacy refers to personal and relational factors affecting a person's ability to     acquire, understand and use information about health and health services. In a need     assessment study it was found that, the health services need to focus on health literacy     factors in the follow up of patients with chronic obstructive pulmonary disease (COPD).      Thus, this project evaluate the effect a of a health literacy partnership health promotion     intervention (hospital, municipalities, university) after discharge from hospital with the     use of motivational interviewing and tailored follow-ups on re-admission, health literacy,     self-management quality of life and cost in people with COPD compared with usual care.   "
5293|NCT03216590|"     Strategies to minimize soft tissue swelling during shoulder arthroscopy are constantly sought     after. The investigators propose an unfamiliar method which may reduce tissue swelling during     shoulder arthroscopy.   "
5294|NCT03216577|"     Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the     association of a sudden and extensive purpura together with acute circulatory failure. The     mortality of PF has been reported to be as high as 50% in previous adult series.     Additionally, patients surviving to the early phase of PF are exposed to a high risk of limb     amputation. The hOPeFUL study aims at assessing the short and long term outcomes of adult     patients admitted in the intensive care unit for a purpura fulminans.   "
5295|NCT03216564|"     Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes     mellitus. Diabetic nephropathy is caused by damage to the small blood vessels in the kidneys     due to uncontrolled blood sugar levels, which mean that the kidneys become less effective at     filtering urine. This is associated with albuminuria (protein in the urine). Treatment with     some drugs reduces the loss of albumin through the urine and delays disease progression.     There is increasing evidence that vitamin D could also be important in management of diabetic     kidney disease. The aim of this study is to investigate the efficacy and safety of a combined     regimen of calcitriol (active vitamin D) and established drugs for diabetic kidney disease.   "
5296|NCT03216551|"     Systemic mediastinal lymphadenectomy is deemed indispensable in lung cancer surgery for     accurate staging and complete resection. However, extensive lymphadenectomy in patients     without nodal metastasis may not improve survival and would increase operative duration and     cause damage to mediastinal structures.Therefore the precise selection of patients without     mediastinal nodal metastasis is the key to avoid unnecessary lymphadenectomy.The     investigator's previous retrospective study shows tumor location and histological subtypes     are exclusive predictors of negative mediastinal nodal disease. The current prospective     observational study is to further verify the staging accuracy of this selective mediastinal     lymphadenectomy strategy.   "
5297|NCT03216538|"     The purpose of this study is to evaluate the safety and efficacy of AS101 1% oral solution as     compared to placebo in patients with neovascular Age-Related Macular Degeneration (AMD).      AMD Patients who underwent 3 consecutive intravitreal anti VEGF injections and have sub     retinal or intraretinal fluid at day 1 of study will be treated orally by AS101 1% solution     or placebo once daily for 24 weeks and will be tested for sub retinal or intraretinal fluid     every 4 weeks by OCT examination. In case of fluid in macula anti intravitreal anti VEGF     injections will be given the same day as needed (PRN). Safety evaluation will be assessed by     adverse events related to treatment of 1% AS101 oral solution or placebo. Efficacy will be     evaluated in terms of duration of fluid free macula in the AS101 treated group as as compared     to placebo treated group;   "
5298|NCT03216525|"     To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion     results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration     of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to     placebo.   "
5299|NCT03216512|"     The purpose of this study is to evaluate performance on the Attention Deficit Hyperactivity     Disorder ( ADHD) Battery of the Cambridge Automated Neuropsychological Test Battery (CANTAB),     including spatial working memory, inhibitory control, and attention while using either a     noise cancelling headphone or sham headphone control in the presence of standardized auditory     distractors in children and adolescents with ADHD.   "
5415|NCT03214991|"     In this study, we investigated the usefulness of circulating tumor DNA as a prognostic factor     in pancreatic cancer patients.   "
5308|NCT03216395|"     In the management of patients with acute upper gastrointestinal bleeding from non-variceal     causes, endoscopic treatment and acid suppression are now the standard of care. Current     endoscopic treatment in the form of either thermo-coagulation or clipping to the bleeding     arteries is highly efficacious in the stopping bleeding. Unfortunately in 5 to 10% of     patients, bleeding cannot be controlled during index endoscopy or recurs after initial     hemostasis. These patients are often elderly with significant co-morbidities. Their bleeding     lesions are large eroding into major sub-serosal arteries. In the few who need surgical     salvage, mortality increases to around 30%. The Over-the-scope-Clip (OTSC) is a device, which     allows endoscopists to capture a large amount of tissue and compress on the bleeding artery.     The OTSC also has a high retention rate. Recurrent bleeding with the use of standard     hemo-clips can occur because of their low retention rate. We reported the use of OTSC with a     high success rate in a case series of patients with refractory bleeding after standard     endoscopic treatment. We have also used OTSC in the treatment of bleeding from     pseudo-aneurysm arising from large eroded arteries in ulcer base. A multicenter randomized     controlled trial that compares OTSC to standard endoscopic treatment in the endoscopic     treatment of refractory bleeding lesions has just been completed. The use of OTSC has been     shown to be superior in achieving hemostatic control and reducing further bleeding. In this     proposed randomized controlled trial, we would test the hypothesis that the use of OTSC, when     used as the first or primary treatment, is superior to standard treatment in achieving     hemostasis and thereby improve patients' outcomes.   "
5309|NCT03216382|"     Excessive and uncontrollable worry has been associated with deficits in attention control.     The Attention Training Technique (ATT; Wells, 1990) is a 12-minute audio recording that was     developed to train attention control, so that individuals could learn to shift their     attention away from maladaptive cognitive processes such as worry. The technique has shown to     be promising at reducing symptoms across a variety of mental disorders (Knowles, Foden,     El-Deredy, & Wells, 2016) and is recommended for use in people who suffer from chronic worry.     To date, little research has been conducted examining the benefits of using this technique in     such a population. The present study aims to examine the immediate and short term effects of     weekly ATT practice, compared to a control condition, in a population that suffers from high     levels of worry about a variety of topics. About one-hundred participants who suffer from     chronic worry will be randomly assigned to listen to the ATT or a control recording, every     day for a week. Changes in attention control, worry, and cognitive processes will be examined     over the course of the intervention period.   "
5310|NCT03216369|"     Carotid artery stenting(CAS) and endarterectomy(CEA) are both important treatment strategy     for patients with ICA (internal carotid artery) stenosis. Three dimensional pseudo-continuous     arterial spin labeling (pCASL) is a noninvasive perfusion imaging modality to detect     reperfusion for recanalization therapy. And it provides information about absolute CBF (ml     100 g−1 tissue min−1) at the brain tissue level. The aim of the present study was to evaluate     the series hemodynamic changes in patients who had conducted CAS or CEA by using 3D     pseudo-continuous arterial spin labeling (pCASL) to explore the potential pattern of CBF     alternation and thus to improve the prevention strategy for hyperperfusion syndrome.   "
5311|NCT03216356|"     This study aims to investigate the utility of d-cycloserine (DCS) for enhancing the effect of     a novel psychosocial intervention, imagery rescripting (ImRs), in adult women with mild to     moderate PTSD symptoms after experiencing sexual assault or interpersonal violence.     Participants will receive 4 sessions of either cognitive behavioral therapy with imagery     rescripting or cognitive behavioral therapy with imaginal exposure and will receive study     medication (DCS or Pill placebo) prior to Session 2 and Session 3.   "
5312|NCT03216343|"     Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases     involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory     microenvironment.   "
5313|NCT03216330|"     Background: Endometriosis affects 10% of reproductive aged females, and can have a negative     impact on sexual quality of life. Endometriosis can cause pelvic pain with deep penetration     during intercourse, as well as other sexual and non-sexual pains. This study will allow us to     determine if an increase in sexual pain is related to central sensitization.      Purpose: The purpose of this study is to determine if there is an association between the     severity of sexual pain and central sensitization in women with endometriosis.      Measurement tools: Data will be collected from the Clinic's Data Registry, an online     questionnaire, a quantitative sensory test (QST) to measure pain-pressure threshold (PPT) as     a marker of central sensitization, and daily entry to an online survey.      Primary Hypothesis: Central sensitization (measured by lower pain-pressure threshold) will be     associated with an increased severity of deep dyspareunia, as well as a tenderness of the     bladder/pelvic floor and depression, in women with endometriosis.   "
5314|NCT03216317|"     Objective: analyze the effects of isometric handgrip exercise on arterial pressure and on the     autonomic cardiac modulation of hypertensive individuals treated in the Unified Health System     (UHS).      Intervention: Patients were randomized into Supervised group (SG) and control group (CG). SG     will perform supervised isometric handgrip exercise for three weekly sessions in four sets     with two minutes of isometric contraction with 30% of maximal voluntary contraction (MVC), In     CG, individuals will be encouraged to increase their level of physical activity.      Measurements: Blood pressure, autonomic modulation   "
5315|NCT03216304|"     To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day     administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly     administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg     rosuvastatin administered alone.   "
5316|NCT03216291|"     Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the     management of patients with Fecal Incontinence. It is not easily available to the vast     majority of patients in the community with this problem. It is therefore imperative that a     more pragmatic therapeutic approach that can be administered easily in the community ought to     be developed. However, whether a treatment program that is based on home-training can be just     as useful as office-based training has not been evaluated. The purpose of this study is to     assess whether having patients train their pelvic floor muscles at home is as effective as     in-office biofeedback training.   "
5317|NCT03216278|"     This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet     manufactured at two different plants.   "
5319|NCT03216252|"     2622/5000 Mitochondrial diseases (MM) are the most common metabolic diseases. Since these     pathologies are very heterogeneous in clinical terms, only the identification of mutations in     nuclear genes or mitochondrial DNA confirms the diagnosis.      The full-scale study of mtDNA by high-throughput sequencing (NGS) is a first step in the     diagnostic approach. The recent introduction of this revolutionary new technology has greatly     increased the efficiency of mutation identification. However, in addition to known pathogenic     mutations, NGS reveals numerous variants whose significance is currently unknown. A major     challenge to obtain a reliable diagnosis is therefore the interpretation of the clinical     impact of these new rare variants which proves to be very difficult.      Pathogenicity criteria allow the classification of variants from benign to pathogenic. One of     the major pathogenicity criteria is a good correlation of heteroplasmic level with tissue or     cellular involvement. Indeed, mtDNA mutations are generally heteroplasmic, which corresponds     to the coexistence of normal and mutated molecules in the same cell or tissue, the most     affected tissues having a high rate of mutation. On a muscle biopsy of an affected patient,     the fibers often present an enzyme deficiency in cytochrome c oxidase (COX-negative) which     can be demonstrated in immunohistochemistry. The single fiber study allows to isolate the     deficient fibers and to quantify the heteroplasmic rate of a variant. The presence of a high     level of heteroplasm in the COX-negative fibers, unlike fibers without deficit, is a strong     argument in favor of the pathogenicity of this variant. Currently, this technique is not used     routinely in diagnostic laboratories but only occasionally in a research framework in some     laboratories. It is a heavy technique that consists of a first stage of laser microdissection     of the various muscle fibers followed by a second step of quantification of the variant from     each fiber. This second step requires a specific focus for each identified variant.      The aim of this pilot study is to develop a new technique for quantification of single-fiber     heteroplasmics isolated by NGS laser microdissection. This, independent of the type of     variant, will avoid the long and costly adjustments required for each new variant identified     and thus facilitate its use   "
5320|NCT03216239|"     After subtotal colectomy, 40% of patients report abdominal pain, gas and diarrhea, and poor     quality of life; whose etiology is unknown. We determined whether small intestinal bacterial     (SIBO or fungal overgrowth SIFO) could cause these sympotoms (> 1 year).   "
5321|NCT03216226|"     The trial's objective is to evaluate the immunogenicity of repeated single doses of     dasiglucagon* and GlucaGen following subcutaneous (s.c.) administration in T1DM patients and     further to evaluate the safety and tolerability of dasiglucagon and GlucaGen.      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207   "
5322|NCT03216213|"     Two surveys are conducted. 1) a representative survey of the public's perception towards     organ donation and 2) different messages to examine effect on family members'     decision-making.   "
5323|NCT03216200|"     A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment     system over a week will result in mycological cure and/or clear nail growth on the treated     hallux toe.   "
5324|NCT03216187|"     This study will test the benefits and risks of using pregabalin perioperatively to prevent     persistent postoperative pain in patients at high risk (>30%) of developing such pain after     breast cancer surgery.   "
5325|NCT03216174|"     Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric     cancer is less invasive method which can increase quality of life. Current stomach preserving     surgery after sentinel lymph node dissection produce transmural communication and expose the     tumor to the peritoneum during operation. An endoscopic full-thickness resection method with     a simple suturing technique that does not expose the gastric mucosa to the peritoneum     (non-exposure simple suturing, NESS) was recently developed.      This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation     in early gastric cancer patients.   "
5326|NCT03216161|"     This study was an update and amplification of exposure measurements of the EPIC-Potsdam     Study, which started in 1994-1998.   "
5327|NCT03216148|"     FET PET 2010 is a prospective, multicentre trial aiming to evaluate the additional benefit of     FET PET in the assessment of remission after first line therapy and during follow-up   "
5328|NCT03216135|"     This study will examine the hypothesis that altered esophageal microbiome leads to the     development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the     confirmation of relational data on the study cohort, using the methods developed and applied     at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to     generate a tissue microarray resource future tissue in-situ validation of microbes. And     finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future     functional studies.   "
5329|NCT03216122|"     Previous studies have shown high success rates of immediately loaded implants on par with     conventionally loaded implants (DL), while a few studies have also reported failure rates.     Various studies can be found in the English literature comparing IL to DL protocol, few of     which used the flapless approach while few used cylindrical implants or were confined to     maxillary anterior region. Furthermore, a perusal of literature revealed no study which used     RVG for radiographic evaluation and evaluated the morbidity at the implant site in normal     healthy adult population. Hence this study would help determine whether the IL protocol is on     par with DL protocol, so as to reduce patient waiting time, prevent space closure and provide     early patient satisfaction from an aesthetic stand point.   "
5330|NCT03216109|"     The purpose of this study is to use a proactive approach to improve symptom management of     patients with thoracic malignancies. In this pilot study, the investigators propose to     evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies     and measure the efficacy of this approach on patient satisfaction with their care, patient     activation, quality of life and use of healthcare resources.   "
5331|NCT03216096|"     The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in     patients with dry eye disease in Taiwan.   "
5347|NCT03215888|"     Obesity is associated with alterations in brain structure and cognitive impairment and is a     risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity     related decline in cognitive function are not fully understood. The long-term goal of this     project is to understand how obesity affects cognitive function, with the aim to develop new     ways to prevent and treat obesity related cognitive decline   "
5348|NCT03215875|"     This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability     and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in     healthy volunteers. The study will be conducted as a two-sequence to period crossover study     to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER     torsemide is a new strength and dosage form.   "
5453|NCT03214497|"     The goal of this study is to compare the oropharyngeal leak pressure of the Protector     Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.   "
25416|NCT02952989|"     This study will examine the safety profile of SGN-2FF. The study will test increasing doses     of SGN-2FF given daily to small groups of patients.   "
5332|NCT03216083|"     There are many risks for patients undergoing surgery, with blood loss and the risk of     resulting anemia and blood transfusion being a common one. Decreasing blood loss with     medication can be an important tool in reducing post-operative complications. Tranexamic acid     (TXA) is an anti-fibrinolytic that inhibits the activation of plasminogen to plasmin. It     inhibits the ability of plasminogen to dissolve fibrin networks, thus decreasing bleeding.     TXA was shown in a systematic review and meta-analysis by Ker et. al in 2013 to reduce     surgical blood loss by an average of 34% with an increased percentage reduction as the amount     of bleeding during surgery decreased. This review also showed that a dose of 1g intravenous     (IV) was sufficient in most adults with no evidence supporting a higher dose.      Vaginectomy or total colpocleisis is a surgical procedure performed for women experiencing     symptomatic pelvic organ prolapse. It is performed in women who have significant vaginal     vault prolapse post-hysterectomy and wish an effective treatment but accept the inability of     having penetrative vaginal intercourse. It is most often performed in older patients who have     multiple co-morbidities that would preclude them from having a more invasive procedure to     correct their prolapse, such as an abdominal sacral colpopexy which involves the placement of     surgical mesh, is a significantly longer procedure, and has more associated surgical risks.      This study will be a double-blind, placebo-controlled, randomized trial looking at whether 1g     IV tranexamic acid compared with placebo reduces blood loss in women undergoing vaginectomy.   "
5333|NCT03216070|"     Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce     molecular response as first line therapy in CML.   "
5334|NCT03216057|"     The primary objetive was to evaluate the safety and efficacy the 3 grams per day of omega-3     in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12     weeks, compared with placebo. Half of subjects received 3 grams of omega 3, while the other     half received placebo.   "
5335|NCT03216044|"     There is no doubt, that surgery is very often the beginning of a chronic pain disorder.     C-section is a worldwide performed operation with increasing trend in the developed countries     .This prospective cohort study evaluated the incidence of persistent pain after childbirth in     respect of the pain status before childbirth and the modus of delivery.   "
5336|NCT03216031|"     Wandsworth Integrated Falls and Bone Health Service (IF & BHS) provides an evidence-based     falls prevention exercise programme, but yearly about 500 of 1800 patients decline     participation or do not continue to exercise. Our study seeks to address this efficiency gap     by developing a gardening programme as an alternative to traditional exercise. In a     preparation period (4/17-5/17) we will explore the special needs of the target population     through interviews and create an age appropriate gardening site at Growhampton, a gardening     project run by the University of Roehampton; from 5/17 to 9/17 a falls prevention gardening     group will be implemented and evaluated.   "
5337|NCT03216018|"     The study is a group randomized controlled trial. High school classes were allocated by     randomization to the intervention or control group by a Randomization function in Excel     computer program. Outcomes were measured by questionnaire at pre-intervention,     post-intervention and 3-months follow-up. The study protocol was approved by Tel Hai College     institutional review board. Parents of all participants, in the intervention and in the     control group, received information about the program and the study and were asked to provide     informed consent.   "
5338|NCT03216005|"     To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous     competence for the treatment of symptomatic chronic venous insufficiency (CVI).   "
5339|NCT03215992|"     This study is looking to see if a new device, diffuse optical tomography (DOT), can detect     prostate cancer. The investigators will also see if DOT can tell the difference between high     risk and low risk prostate cancers.   "
5340|NCT03215979|"     In this study investigators are trying to determine the benefits of using platelet enriched     plasma during the second stage of auricular reconstruction. The intervention will be blinded     to the surgeon and the surgical team. The main outcome will be the evaluation of the     integration rate of the skin full thickness graft used to coat the auricular frame.   "
5341|NCT03215966|"     The primary objective of this study is to demonstrate that macitentan and tadalafil     administered as a fixed combination is bioequivalent to both compounds given as separate     tablets given at the same doses as in the fixed combination (i.e. whether the amounts of     macitentan and tadalfil which reach the blood are comparable).   "
5342|NCT03215953|"     Offloading is the concept of relieving pressure to help prevent/cure plantar ulcers,     especially in diabetic patients. Many forms of offloading are available, with many     limitations to apply in clinical practice. In this study, the investigators compare cast shoe     with forefoot offloading shoe considering effectiveness, complications, compliance and     patient's appreciation.   "
5344|NCT03215927|"     A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous     Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome.   "
5345|NCT03215914|"     Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a     hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes     a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3     Hyperinsulinemic Clamps done at: Baseline (before starting the device and after completing     the screening), 6 months (after using the device 6 months), and after using the device for 18     months. This metabolic testing will allow us to measure improvement in hypoglycemia     awareness.   "
5346|NCT03215901|"     The mass provision of HIV treatment in rural KwaZulu-Natal, South Africa has raised adult     life expectancy by 18 years since 2003. We will conduct a population-based survey to assess     young adults' beliefs about HIV, HIV treatment, and expectations for the future in the era of     mass HIV treatment. We will conduct a randomized evaluation to assess whether a short video     providing young adults with information on longevity gains from HIV treatment affects young     adults survival expectations, hope for the future, and health and educational behaviours,     including uptake of HIV testing and treatment services, the study's primary outcome.   "
25584|NCT02950805|"     This study will assess the effect of inhaled AZD5634 on Mucociliary clearance (MCC) in     patients with Cystic fibrosis (CF) after single-dose administration.   "
24484|NCT02965183|"     Examination of the correlation between adenoid hypertrophy and body temperature in candidate     children for adenoidectomy after exercise   "
5349|NCT03215862|"     This is a randomized, double-blinded, controlled trial. This study is a head to head     comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients,     with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to     either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally     and will be continued throughout the procedure. A IVF bolus will be given at the end of the     procedure and then continued as a continuous infusion. Our null hypothesis is that there will     be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the     infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR     solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to     patients receiving NS solution infusion.   "
5350|NCT03215849|"     A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current     intended purposes.      The study will comprise 10 patients. Recruitment of patients will take place from The     University Hospital of Wales (Cardiff & Vale University Health Board [CVUHB]). All patients     recruited will have septal flattening during exercise demonstrated using contrast stress     (exercise) echocardiography.      All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three     of the following settings on separate visits (with a gap of up to 5 days between visits) in     random order:      Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP   "
5351|NCT03215836|"     The objective of this pilot study is to determine whether obesity and metabolic syndrome are     in fact synergistic in relation to airway nitric oxide (NO) biology. To do so, the     investigators want to determine how obesity and the metabolic syndrome relate to metabolism     in bronchial airway epithelial cells and the nasal epithelium.   "
5352|NCT03215823|"     The usefulness of videolaryngoscope has been verified by several studies, and the frequency     of videolaryngoscopy is increasing in clinical practice. Data on the use of     videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the     use of previously used macintosh laryngoscopes. In addition, videolaryngoscopy increases the     success rate of endotracheal intubation compared to conventional macintosh laryngoscopy, but     endotracheal intubation with videolaryngoscope is not successful in all cases with one     intubation attempt. Therefore, if the difficult endotracheal intubation with the     videolaryngoscope can be predicted in advance, it may be possible to improve the success rate     of intubation by reducing unnecessary use of the videolaryngoscope and preparing other     equipment. There are many studies on the preoperative examination that can predict the     difficulty of intubation when using a macintosh laryngoscope. However, there are still     attempts to find screening tests that predict precisely the difficult endotracheal intubation     because the accuracy of screening tests is not high. In particular, there is a lack of     research on factors that can predict difficult endotracheal intubation when using     videolaryngoscope. Therefore, the investigators aimed to investigate the factors predictive     of difficult endotracheal intubation when attempting intubation using videolaryngoscope.   "
5353|NCT03215810|"     Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating     lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of     immunotherapy - a drug that is used to boost the ability of the immune system to fight     cancer, infection, and other diseases.   "
5354|NCT03215797|"     A prospective, double-blinded study. The present study consisted in applying Stroke volume     variation fluid guided therapy to old patients (65 years old) undergoing radical resection of     colon surgery. The aim of this study is to compare the effects of norepinephrine and     phenylephrine in treating perioperative hypotension, and to find the safest and most     effective vasopressor for elderly.   "
5355|NCT03215784|"     Obesity is one of the most concerning health issues in the modern world, especially due to     its association with greater risk of developing a wide range of chronic diseases.     Pre-gestational obesity may increase the chances of maternal and fetal morbimortality, such     as gestational diabetes mellitus, preeclampsia, macrosomia and, even, fetal death. It may     also lead to long term disorders, enhancing the risk of excessive adiposity and metabolic     syndrome in later life and, thus, contributing to the maintenance of the obesity cycle and     its health effects through the subsequent generations. Alterations in placental function are     thought to be deeply involved in this scenario, however further research on its molecular and     biological mechanisms is needed. During pregnancy, there is a physiological enhancement of     the inflammatory state, marked by higher circulating cytokines and macrophage placental     infiltration, which favors fetal nutrient supply and adequate growth; however, this response     is exacerbated in women with pre-pregnancy obesity, leading to adverse outcomes. In this     context, interventions aiming to reduce excessive inflammation may prevent or minimize the     negative impact of pre-pregnancy obesity on both maternal and offspring's health. There is     strong evidence suggesting an important role of n-3 LC-PUFA (EPA and DHA) on the attenuation     and resolution of inflammatory states, besides influencing maternal lipid profile, fetal and     infant adipogenesis and neurodevelopment. Additionally, the consumption of probiotic     supplements during gestation seams to promote adequate maternal weight gain and improve the     profile of inflammatory molecules secreted in the milk. Therefore, the nutritional     interventions with fish oil, as a source of EPA and DHA, or probiotics, in women with     pre-pregnancy obesity, may change the intrauterine environment and reduce the risk of both     short and long term metabolic disorders. This study aims to investigate the metabolic and     molecular changes promoted by gestational obesity and evaluate the effectiveness of different     dietary interventions (fish oil or probiotic) on preventing or minimizing such alterations.     We expect to contribute to the understanding of the physiological and molecular mechanisms     underlying maternal obesity and its association with adverse pregnancy outcomes, associated     with increased risk of chronic diseases in adulthood.   "
5356|NCT03215771|"     The objective of this study is to document longitudinal outcomes in persons with traumatic     brain injury (TBI) using the myoelectric upper limb orthosis with powered elbow and grasp     using both patient centric performance and patient reported outcome measures. Longitudinal     observation will allow us to detect both the initial therapeutic effects as well as the later     functional outcomes of orthosis use. We plan to recruit 15 Veterans and non-veterans who have     TBI and upper limb impairment. The study requires 29 visits over 22 weeks and is divided into     four parts: enrollment, orthotic fitting, therapy/training (9 weeks), and home use (9 weeks).     Therapeutic and functional benefits will be evaluated every 2 to 3 weeks over 18 weeks using     simple, short clinical tests.   "
5357|NCT03215758|"     A randomized, multicenter, double-blind, placebo- controlled parallel-group study to     determine the efficacy and safety of QAW039, compared with placebo, when added to     standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with     uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1     second (FEV1) at the end of 12 weeks of treatment.   "
5543|NCT03213327|"     The validity and the sensitivity of different measures implemented in the web application     StayOk are investigated. The measures are used primarily for the assessment and the early     identification of psychosocial risks. Secondarily, the results of the assessment are applied     to generate health-promoting advices for the user of the web application.   "
5358|NCT03215745|"     To determine the efficacy of program of prevention of delirium in critically ill patients     from the intensive care units of Bucaramanga and Floridablanca. Methods: The study will be a     randomized controlled clinical trial in 600 critically ill patients recruited at 24 hours     from arrival on the intensive care units of Bucaramanga and Floridablanca, without delirium,     with ≥50% in the PREDELIRIC scale score, who comply with the inclusion and exclusion. The     patients will be randomized in blocks to one of the two groups, intervention group (delirium     prevention program, n=200) with control group (usual care; n= 400), the study will compare     the incidence of delirium in both groups. Patients will be followed every day with Confusion     Assessment Method for the Intensive Care Unit (CAM-ICU) until the patient presents delirium,     exit to hospitalization or death. Delirium prevention program includes individualized     nonpharmacological interventions such as multisensory stimulation, cognitive stimulation,     activate the functional and family involvement. The study has received ethical approval from     the University of Santander   "
5359|NCT03215732|"     This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in     rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both     health-related and socio-economic consequences.   "
5360|NCT03215719|"     This will be a phase II single-arm clinical trial. The purpose of this study is to determine     the feasibility of deescalating chemoradiation treatment based onmid-treatment tumor     response. The primary objective of this study is to evaluate progression-free survival at 2     years.   "
5361|NCT03215706|"     The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with     chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as     the first treatment given for the disease   "
5362|NCT03215693|"     The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) capsule     in patients with ALK-positive non-small cell lung cancer previously treated with     crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.   "
5363|NCT03215680|"     Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in     populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce     urine volume and consequently increase UIC independent of iodine status. This could lead to     an overestimation of population iodine intake, thus masking iodine deficiency in vulnerable     groups.      In this longitudinal observational cohort study in women of reproductive age we will collect     24h and spot urine samples in the summer and winter season. The influence of high temperature     climates on UIC, measured and estimated urinary iodine excretion will be estimated.   "
5364|NCT03215667|"     Purpose of the single arm study is to clinically and histologically evaluate alloplastic     in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and     polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth     with non-containable extraction sockets.   "
5365|NCT03215654|"     Objective: To evaluate the efficacy of 3 sensitivity and mental health literacy programs for     young students in the increase of mental health knowledge, to help seeking and reducing the     stigma in order to prevent mental disorders and to reduce symptoms.      Design: Multicenter randomized clinical trial school-based during 12 months follow up.     Setting: Educational centers of secondary education (E.S.O) (public or private) of Barcelona.     Subjects: 408 students between 13 and 18 years old who attend 3rt ESO in 8 randomized schools     of Barcelona.      Interventions: 3 intervention groups of ascending intensity: 1) Sensitivity Program Mental     Health (SP)(1h); 2) Mental Health Literacy Program (MHLP) (6h); 3) MHLP more Stigma Reduction     (ER) ( MHLP+RE)(7h).Control group: waiting List.      Measures of results:1) Mental Health Literacy; 2) Stigma associated with mental health; 3)     Mental Symptoms and Positive Mental Health (SDQ); 4) Bullying and Ciberbullying; 5) Quality     of life (E-5D); 6) Intent to change; 7) Help Seeking (AHSQ); 8) Use of Health Services and     Treatment and 9) Satisfaction.   "
5366|NCT03215641|"     This study evaluates the role of personal activity trackers to help improve weight loss or     weight maintenance for children and their parents enrolled in a comprehensive weight loss     program.   "
5367|NCT03215628|"     Transcranial contrast-enhanced ultrasound for evaluation of cerebral blood flow during     pediatric cardiac surgery. This study is aimed as a feasibility study prior to conducting a     lager prospective clinical trial including neurologic and developmental outcome measures.   "
5368|NCT03215615|"     Non-carious cervical lesion is frequently associated with gingival recession, resulting in a     combined lesion that has a different treatment prognosis when the two lesions appear alone.     The literature presents few studies that propose a multidisciplinary approach (restorative     and root coverage surgery procedures) to optimize the treatment of this combined lesion. The     previously proposed approaches and materials have limitations and an optimal clinical     protocol has not been established yet. Thus the aim of this study is to evaluate a novel     multidisciplinary protocol with two resin composites and two different adhesive systems     through a randomized clinical trial and laboratory studies. 120 combined lesions will be     randomly assigned to one of the following groups: NP + TE (n = 30) - Partial restoration of     cervical lesions with nanofilled composite and total-etch adhesive system and periodontal     surgery for root coverage, NP + UA (n = 30) - partial restoration of cervical lesions with     nanofilled composite and self-etching adhesive system and periodontal surgery for root     coverage, MH + TE (n = 30) - partial restoration of cervical lesions with microhybrid     composite and total-etch adhesive system and periodontal surgery for root coverage, MH + UA     (n = 30) - partial restoration of cervical lesions with microhybrid composite and     self-etching adhesive system and periodontal surgery for root coverage. Restorations will be     assessed using the USPHS criteria after one week, six months and twelve months.   "
5411|NCT03215043|"     First, it will be evaluated whether supplementation of eriocitrin reduces hyperglycemia and     insulin resistance, significantly reducing the risk of diabetes. The effects of eriocitrin on     the lipid profile, inflammatory, endothelial, hepatic and renal biomarkers will also be     evaluated. It is expected that metabolic parameters that constitute risk factors for diabetes     and associated chronic diseases are expected to be improved by supplementation with     eriocitrin   "
5412|NCT03215030|"     The purpose of this Phase 1 portion of the study is to determine the safety and tolerability     of TAK-573 monotherapy in participants with refractory multiple myeloma (MM) and Phase 2a     portion of the study is to provide a preliminary evaluation of the clinical activity of     TAK-573 monotherapy in participants with refractory MM.   "
5369|NCT03215602|"     Osteoarthritis (OA) of the knee is a chronic musculoskeletal disease, and a major cause of     pain and disability worldwide. Exercise has previously demonstrated good effect in     alleviating OA symptoms. However, optimal exercise modes in OA are currently unknown.      This study seeks to evaluate the effects of supplementary focused, knee extensor strength     training in addition to neuromuscular exercise (NEMEX) and education in people with OA of the     knee as performed in Good Life with osteoArthritis in Denmark (GLA:D ᵀᴹ).      Through a randomized design, study participants will either be allocated to 12 weeks (twice     weekly) of NEMEX and education or 12 weeks (twice weekly) of NEMEX and education and focused,     knee extensor strength training.      The primary outcome measurement for this study is the Knee injury and Osteoarthritis Outcome     Score, subscale Activities of Daily Living (KOOS-ADL), which is a self-reported questionnaire     on daily life activities. Other outcomes include parameters of maximal muscle strength and     muscle power, muscle imaging, physical function, pain and self-reported health status.   "
5370|NCT03215589|"     Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy     (NIRS) derived cerebral oximetry has been associated with significant postoperative     morbidity. If significant desaturation occurs during this period, it may represent an ideal     opportunity to further optimize the postoperative care of these patients.   "
5371|NCT03215563|"     Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent     stroke, the 18F-fluoride positron emission tomography-computed tomography highlights     high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose.     Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to     build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of     patients with acute transient ischaemic attack or ischaemic stroke. Investigators will     specifically examine the association of 18F-fluoride uptake with multiparametric magnetic     resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and     lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain     imaging, an assessment of the functional consequences of 18F-fluoride-positive     atherosclerotic plaque will be performed. If successful, this technique has a number of     valuable translational applications including the better selection of patients for carotid     intervention.   "
5372|NCT03215550|"     Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent     stroke, the 18F-fluoride positron emission tomography-computed tomography highlights     high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose.     Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to     build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of     patients with acute transient ischaemic attack or ischaemic stroke. Investigators will     specifically examine the association of 18F-fluoride uptake with multiparametric magnetic     resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and     lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain     imaging, an assessment of the functional consequences of 18F-fluoride-positive     atherosclerotic plaque will be performed. If successful, this technique has a number of     valuable translational applications including the better selection of patients for carotid     intervention.   "
5373|NCT03215537|"     This study aims to propose a perioperative comprehensive intervention based on health     behavior model to improve cardiopulmonary function and quality of life among lung cancer     patients following   "
5374|NCT03215524|"     This is a randomized phase II open label, study of daratumumab, weekly low-dose oral     cyclophosphamide and low-dose dexamethasone with or without pomalidomide in patients with     relapsed and refractory multiple myeloma. The study consists of two arms. Patients will be     randomized into ARM A and ARM B in 1:1 ratio.   "
5375|NCT03215511|"     This is a Phase 1/2, multi-center, open-label study designed to evaluate the safety and     efficacy of LOXO-195 when administered orally to patients with NTRK fusion cancers treated     with prior TRK inhibition or non-fusion NTRK altered cancers regardless of prior kinase     inhibitor treatment.   "
5376|NCT03215498|"     The aim of the study is to compare the pharmacokinetics (i.e. the course of the blood     concentrations of the administered trial drug) of faster-acting insulin aspart (faster     aspart), and the currently marketed formulation of insulin aspart (NovoRapid®) when given as     a bolus using an insulin pump in people with type 1 diabetes. The pharmacodynamic response     (i.e. the course of the blood sugar lowering effect of the administered trial drug) and the     safety and tolerability of faster aspart and NovoRapid® will also be assessed.      The participants will be in the study for approx. 21 days. Each participant will have 5     visits to the clinic, with an overnight stay at both dosing visits. Participants will have a     number of tests, and they will have to give blood and urine samples.   "
5377|NCT03215485|"     Intervention targets youth ages 14 - 19 participating in soccer teams. The intervention group     will be given face to face nutrition lessons and have access to an online immersive learning     environment. The comparison group will not. The project will test if the immersive learning     environment is effective in preventing unhealthy weight gain.   "
5378|NCT03215472|"     This study will test whether a digital health intervention (DASH Cloud) using smartphones can     improve diet quality among women at risk for cardiovascular disease. The DASH (Dietary     Approaches to Stop Hypertension) Diet has been proven to lower blood pressure, yet     dissemination efforts remain poor. This study aims to use technology to improve adherence to     DASH.   "
5379|NCT03215459|"     Cardiopulmonary exercise testing (CPET) has been shown to be superior to American Society of     Anaesthetist classification (ASA) in predicting peri-operative risk. The most common     performance status used is the World Health Organisation (WHO) (0-4), with a clinician agreed     differentiation of the subsets of 0-2 and 3-4; variability also exists within these subsets.      With this there rises a concern that fit older patients may not be offered appropriate     chemotherapy treatment. This observational study will assess whether cardiopulmonary exercise     testing (CPET) offers additional benefit over that of WHO Performance status (PS) in the     assessment of patients fitness for palliative chemotherapy for pancreatic cancer, by     identifying those patients who might survive longer and tolerate chemotherapy better, thus     predicting their outcome.   "
7811|NCT03183635|"     Stroke survivors have higher risks of falling compared to other healthy non-stroke adults.     Stroke patients' balance can be trained by Kinect-based training that enable user friendly     and interactive training.   "
5380|NCT03215446|"     Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the     myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class     effect, and Sevoflurane is the most widely used today.      In humans, the protective effects of halogenated agents have principally been studied in     heart surgery and have shown encouraging clinical results. It seems that HAA induce both     pre-conditioning of the myocardium (early and late) and post conditioning.      Given these protective effects of HAA, in 2007, the American Heart Association (AHA)     recommended the use of HAA for anaesthesia maintenance in non-cardiac surgery in patients     with a high cardio-vascular risk. The aim of this study is to show a decrease in     rhabdomyolysis and tissue distress (kidneys, myocardium and liver), thanks to Sevoflurane     anaesthesia, in the post-operative period following vascular surgery with clamping   "
5381|NCT03215433|"     Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis     (MS) in the context of a nominative temporary authorization for use (TAU) as a     disease-modifying treatment for their MS. A recent study showed that with this treatment,     more patients experienced an improvement after one year in comparison with patients given a     placebo.      The objective of this study is to identify blood biomarkers to determine good responders as     early as possible. In addition, the blood parameters studied will make it possible to better     understand the mechanisms of action, that have a beneficial effect on multiple sclerosis.      The management of patients will not be modified: same number of consultations (at the     prescription, at 3 months, at 12 months), same clinical examination, and the same number of     blood samples (at the prescription, at 3 months, and at 12 months).   "
5382|NCT03215420|"     The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH)     in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional     explorations, namely electrocochleography and dephasing of acoustic distortion products     (which are modified by the EH).      The research hypothesis is that the examinations will show agreement in the diagnosis of EH,     and that the results obtained (quantitative values) will vary in the same direction over time     and during flares of MD.   "
5383|NCT03215407|"     Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and     compound betamethasone.      Study design: A randomized, single-blind, parallel controlled and one center trial design.      Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly     divided into tocilizumab group and compound betamethasone group. In the baseline period, the     investigators will collect patients' general information, disease information, disease     activity score, laboratory results and images of articular ultrasound. After 4 weeks of     injection, patients will be asked to come back, and their disease information, disease     activity score, laboratory results as well as images of articular ultrasound will be     collected. Finally, these data will be sorted and analyzed.      Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better     than that of compound betamethasone.   "
5384|NCT03215394|"     The Social ABCs is an evidence-based, developmentally informed, caregiver-mediated     behavioural intervention for toddlers with suspected or confirmed Autism Spectrum Disorder     (ASD). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied     Behaviour Analysis), and responsive parenting. The two key targets of this program are     functional verbal communication and positive caregiver-child affect sharing. This     intervention takes place in the context of play and daily routines, and in all contexts is     made to be fun.      In both a pilot study and a recently completed randomized control trial, toddlers whose     caregivers received training in the Social ABCs intervention showed significant gains in     early language development (both responsivity and initiations), increased child smiling     (mediated by parent smiling), and a trend toward increased social orienting (one important     manifestation of social attention).      Despite the social-communication benefits demonstrated through the Social ABCs, the research     team is also motivated to foster the attentional abilities of toddlers with emerging ASD in     response to compelling evidence that early attentional control abilities may play a central     role in the emergence of ASD. Based on this knowledge, the current study targets not only     social-communication challenges and affect sharing (as per the existing Social ABCs     intervention), but also attentional control in toddlers with suspected or confirmed ASD.     Using a structured, computerized attention-training protocol, this RCT evaluates the impact     of supplementing the standard Social ABCs intervention with pre-intervention attentional     control training.   "
5385|NCT03215381|"     This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390     in healthy volunteer males.   "
5386|NCT03215368|"     The subjects of the present study were from the Ma'anshan Birth Cohort (MABC) study, a     prospective pregnancy and birth cohort study designed to examine the relationship between     prenatal exposure and pregnant outcomes, child health and development.   "
5387|NCT03215355|"     This is a feasibility study requiring only three patients to serve as a proof of concept that     gadoxetate disodium (a liver specific contrast agent) can be used to improve images taken     just before liver SBRT treatments.      The hypothesis of this research is that if gadoxetate disodium improves image quality at the     time of treatment, then it can be used for image guided radiotherapy (IGRT). Image guidance     is the procedure where the 3D CT image that is used to plan a radiotherapy treatment, is     aligned to a 3D image taken just before treatment. The better the alignment, the more     accurate the treatment, which is crucial for high dose treatments such as SBRT.      This research is important for two main reasons. First, it is much less invasive than the     standard of care which involves surgically implanting markers in the liver that can move over     time. The benefit to harm ratio for surgery, compared to an injection, is much more dramatic.     Furthermore, not all patients are surgical candidates, and therefore in those cases radiation     oncologists must prescribed a larger area to treat to ensure that none of the cancerous     region is missed. The drawback to this method is the irradiation of more normal tissue than     necessary, which although deemed to have a greater benefit than harm, is not ideal. Secondly,     this research has strong implications in the field of radiation oncology to move towards     patient oriented radiotherapy treatments. If successful, radiation treatment to the liver     could be performed in less treatments because of the confidence given to radiation     oncologists of the cancer location; knowing exactly the healthy liver regions to avoid.   "
26417|NCT02939924|"     To assess safety and efficacy of the Kanshas DCB in the treatment of de novo lesions in the     superficial femoral (SFA) and/or popliteal arteries.   "
5388|NCT03215342|"     Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one     of the leading causes of death and disability for children and adolescents. Importantly,     injuries affecting the brain in childhood or adolescence appear during a time of development     when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not     only impact cognitive functions at the time of injury or onset of disease, but also cognitive     functions that are yet to develop. Changes in cognitive function, and in particular executive     dysfunction due to acquired brain injury, cause significant real-life disability, yet solid     evidence in support of executive functioning interventions for children and adolescents is     lacking. In the present study different group-based cognitive rehabilitation interventions     will be compared. The aim of the study is to investigate if a group-based brain training     intervention is able to improve executive function in children and adolescents after acquired     brain injury. Efficacy will be assessed immediately after intervention, but also six months     after the intervention. The project is in line with international research efforts aimed at     establishing more knowledge about how children and adolescents with brain injuries respond to     cognitive rehabilitation.   "
5389|NCT03215329|"     During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of     patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication     including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar     recruitment manoeuvres (ARM). Two methods for ARMs have been described. A sustained     continuous positive airway pressure (CPAP) or a stepwise increase in PEEP.The transient     increase in intrathoracic pressure during ARMs decreases venous return and increases     pulmonary vascular resistance. This result in a decrease in right and left ventricular stroke     volume (SV). Finally, the deleterious hemodynamic effects of ARMs may be exacerbated by     hypovolemia, heart failure, and in patients with chronic treatment wich impedes     cardiovascular responses to hypovolemia. At our best knowledge, there is no study which     compared the hemodynamic effects of ARM using sustained CPAP or stepwise increase in PEEP.     Consequently, the present study was designed to examine the hemodynamic effects of 2 ARM     methods in anesthetized patients.   "
5390|NCT03215316|"     Expiratory flow limitation (EFL) is defined as a dynamic condition that expiratory flow     cannot be further increased with higher expiratory driving pressure. Under mechanical     ventilation, it can cause intrinsic positive end-expiratory pressure (PEEP) and dynamic     hyperinflation, and be associated with worse clinical outcome. The detection of EFL however     needs special maneuvers and offline analysis of flow-volume curves, which are infeasible in     routine practice and cannot be used during real-time monitoring. The investigators propose a     new and simple approach using flow derived parameters to detect EFL in real time without     needing any intervention.   "
5391|NCT03215303|"     The purpose of this study is to verify the effects of continuous positive airway pressure     (CPAP) on exercise capacity of children and adolescents with severe therapy-resistant asthma     (STRA). A randomized, controlled, crossover clinical trial will be conducted. We expect the     use of CPAP to increase exercise capacity in children and adolescents with STRA.   "
5392|NCT03215290|"     Non-anatomical liver resection with appropriate resection margin was regarded as a potential     curative treatment for selected major hepatic carcinoma due to preserving maximal normal     liver, especially in cirrhotic patients. But occurrence of cutting surface related     complications become a main challenge.   "
5393|NCT03215277|"     Study to evaluate the efficacy and safety of Bimekizumab compared to Certolizumab Pegol in     the treatment of subjects with active ankylosing spondylitis (AS)   "
5394|NCT03215264|"     The main purpose of this study is to find the best dose of hydroxychloroquine (HCQ) when     given in combination with regorafenib and entinostat.   "
5395|NCT03215251|"     The study evaluates the effectiveness of an Intervention Bundle on Thirst Intensity and Dry     Mouth among Patients admitted in ICUs. Patients were randomized into two groups -     Experimental and Control group. Experimental group received intervention Bundle whereas     control group didn't receive any intervention. Usual care was continued in both the groups.   "
5396|NCT03215238|"     Pleth Variability Index (PVI) is a variable that is derived from photoplethysmography (PPG)     signal. It is used as a surrogate for intravascular volume status intraoperatively. PVI can     have significant amount of baseline variability which appears to oscillate at a very low     frequency (5-10 minute cycles). This study aims to investigate the origin of these baseline     oscillations.   "
5397|NCT03215225|"     The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995.     Type of complication, success, new endodontic diseases and number of success were reported.     Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.   "
5398|NCT03215212|"     The study evaluates the effectiveness of ear plug, eye mask and ocean sound on sleep quality     among ICU patients. 60 patients were randomly allocated to group 1 and group 2 by lottery     method i.e 30 in each group. Group 1 received earplugs and eye masks on the first night     followed by washout period on second night and received ocean sound on third night, while the     group 2 received ocean sound on the first night followed by washout period on second night     and received earplugs and eye mask on third night.   "
5399|NCT03215199|"     This is a randomized controlled trial comparing a web-based psychosocial screening     application to usual care in a cohort of surgically-treated head and neck cancer patients to     determine its efficacy in monitoring depression and distress, and prompting necessary     psychiatry/psychology referrals. In addition, treatment adherence, rehabilitation and return     to work, primary care utilization, and survival will be monitored.   "
5413|NCT03215017|"     A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery     due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and     medication that can help control of the bowel movement in patients with low anterior     resection syndrome.   "
5476|NCT03214198|"     The purpose of this study is to investigate the safety and efficacy of long-term     administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine     clinical setting in patients receiving NSAIDs.   "
5937|NCT03208192|"     Background: until now, there is no agreement about the safest and feasible method for liver     parenchyma transection during laparoscopic liver resection.      Study design: prospective, randomized, single-center The purpose of the study: comparison of     short-term results of two methods of parenchyma liver transection during laparoscopic liver     resection   "
5400|NCT03215186|"     Prevention and treatment of the reversible childhood blindness, including congenital     cataracts (CC), has been listed as a significant component of the international programme     VISION 2020 - the Right to Sight launched by WHO in 1999. However, there is still a lot of     unsolved problems regarding to CC, especially in developing countries, such as the delayed     presentation and treatment to the hospitals, the lack of specialized treatment departments,     and the poor treatment prognosis. With the two children policy opened in China in 2016, many     CC parents hesitate to have a second child due to the potential high risk of CC. Date on     detailed clinical characteristics of the CC children, including the demography,     pregnancy-labor history, and living condition, are crucial for developing the national     screening strategies of CC in Pregnant women. However, to our knowledge, it still lacks of     thus large population-based and comprehensive investigations of the characteristics of CC     children in developing countries.   "
5401|NCT03215173|"     This study plans to learn more about how to increase postpartum weight loss and how to     decrease risk factors for postpartum women at increased risk for diabetes and heart disease.     The program is delivered using a mobile application (app) and a lifestyle coach. This mobile     application is developed for women who are at higher risk for diabetes and heart disease.     Women who have gestational diabetes, (diabetes during pregnancy, or GDM), gestational     hypertension (high blood pressure), and/or preeclampsia (high blood pressure and protein in     the urine), and/or small-for gestational-age, and/or preterm (early) delivery during their     pregnancies have a higher risk for diabetes and heart disease. This mobile application was     developed using the latest research studies and using the evidence-based Diabetes Prevention     and Colorado Weigh programs. The goal of the program is to help women lose weight and     participate in physical activity after delivery.   "
5402|NCT03215160|"     There is no definite evidence about the most effective treatment approach in early-stage     rehabilitation after total knee arthroplasty surgery. The purpose of this study is to     investigate the effects of mobilization exercises applied with classical exercises on pain,     joint range of motion, edema, function, quality of life and patient satisfaction in early     stage rehabilitation after total knee arthroplasty surgery.   "
5403|NCT03215147|"     The investigators assess the prevalence of airway disease associated with idiopathic     pulmonary fibrosis in Korea, and evaluate the effect of these airway diseases on the symptoms     and quality of life of patients with idiopathic pulmonary fibrosis.   "
5404|NCT03215134|"     This uncontrolled pilot seeks to develop a novel intervention based on Compassion Focused     Therapy (CFT), that reduces self-criticism and improves psychological wellbeing. The     researchers aim to assess the the acceptability and feasibility of providing such an     intervention within a primary mental health care service; and a preliminary indication of the     the effectiveness of this intervention?   "
5405|NCT03215121|"     During induction of anesthesia in children, the investigators have observed significant     variability in mask holding technique at our institution among different anesthesia     practitioners. Some hold the face mask using one hand and others use two hands. The aim of     our study is to comparatively evaluate the extent of airway obstruction in children whilst     anesthetic mask is held with one hand with jaw thrust versus mask held using two hands with     chin lift by anesthesia provider during induction of anesthesia in children.   "
5406|NCT03215108|"     The aim of this animal study is determining the technical feasibility of the novel     flower-type covered self-expandable metal stent (F-CSEMS) and investigating whether the novel     flower-type covered self-expandable metal stent (F-CSEMS) could prevent cholecystitis and     pancreatitis, comparing with conventional covered self-expandable metal stent (C-CSEMS).   "
5407|NCT03215095|"     The purpose of this study is to find out what effects, good and/or bad, a drug called     durvalumab combined with Thyrogen-stimulated RAI, has on the patient and thyroid cancer.     Durvalumab is a drug that has been developed to activate the immune system by blocking a     protein called programmed death ligand-1 (PD-L1) that can be present on tumor and normal     cells, including immune cells.   "
5408|NCT03215082|"     The aim of this research program is to 1) Evaluate potential problems with vision, inner     ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2)     Evaluate treatment programs for individuals with eye and inner ear problems that persist for     greater than 10 days following injury.      This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of     any severity. An initial evaluative phase using the best available technology to evaluate eye     and inner ear function will be performed, and compared with typical tests that are used in     the clinic. If symptoms and functional problems remain 10 days after injury, participants     will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex     and attention exercises as per our pilot studies) or a control group (typical     rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement     of goals (moderate and severe TBI) and quality of life. It is expected that this program will     inform clinical practice and future research leading to a treatment program in TBI that     includes multiple components.   "
5409|NCT03215069|"     Double-blind, parallel arm, randomized controlled trial, in which non-lactating women with     recent GDM who are between 6 to 36 months postpartum to be randomized to either empagliflozin     10 mg daily or matching placebo. The duration of treatment will be 48-weeks. Beta-cell     function will be assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2), measured on oral     glucose tolerance test (OGTT) at baseline, 24-weeks, 48-weeks, and after a 4-week washout.   "
5410|NCT03215056|"     This is a randomised, double-blind, multicentre, placebo controlled study to evaluate the     safety and efficacy of methoxyflurane (Penthrox®) for the treatment of acute pain in children     and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department     with minor trauma). It is conducted as part of the Paediatric Investigation Plan (PIP) agreed     with the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).      The study aims to provide evidence under blinded controlled conditions that Penthrox is safe     and effective in patients aged 6 to less than 18 years presenting to ED with pain associated     with minor trauma.   "
5427|NCT03214835|"     The study will take place at Rambam medical center, department of Otolaryngology Head and     Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate     for laryngeal or hypopharyngeal biopsies will be recruited.   "
5416|NCT03214978|"     The prevalence of papillary thyroid micro-carcinoma (PTMC) increased rapidly in recent years     but the design of treatment is controversial because a majority of them are indolent.     Therefore, to recognize which PTMC is of strong progressive potential which should be     operated is very crucial. Fine needle aspiration (FNA) pre-surgery could obtain tumor cells     which could be used in genetic analysis. To date, there is no specific way to evaluate the     aggressive potential of a PTMC pre-surgery. So, the purpose of this proposal is to screen     genetic mutations of the aggressive type of PTMC. The candidate did a whole exome sequencing     on 3-3 pairs of PTCs and found some SNPs and Indels in TP53、TTN、PDF. To further investigate     those mutations, a target region sequencing will be done in 40 pairs tumor samples. And     ultimately to find out which genetic event could contribute to strong aggressive potential of     PTC. The mutations details would be design to test the FNA and tissue sample to validate if     the genetic testing based on FNA is reliable. The gene test results would be evaluated with     sonographic features to predict the potential of small thyroid carcinoma before surgery. This     project won't aim to study the function and mechanism of specific genes but just screen them     out. So, the fund would cover the fee of the whole study and this study is very likely to     achieve the goal.   "
5417|NCT03214965|"     This study is designed to compare the knowledge, satisfaction and self-esteem of kidney     transplanted adolescents measured through questionnaires between two groups: patients     undergoing conventional treatment with no other intervention versus patients undergoing     conventional treatment and receiving additional educational and consultative actions using a     closed facebook group.   "
5418|NCT03214952|"     The purpose of this study is to evaluate the safety and efficacy of vonoprazan tablets     (Takecab tablets) in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in     the routine clinical setting.   "
5419|NCT03214939|"     The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy     method on the basis of autologous antigen-activated dendritic cells in the treatment of     patients with colorectal cancer.      This technology is intended for complex treatment of patients with colorectal cancer and is     aimed at preventing the occurrence and treatment of secondary foci. The need for this     technology is justified by the widespread occurrence of colorectal cancer, a decrease in the     average age at onset of the disease, and the chemoresistantness of locally advanced forms of     cancer.   "
5420|NCT03214926|"     Recently, Mark Morris Dance Group, and created Moving Through Glass (MTG), a project that was     funded by Google, as a portable, round-the-clock extension of the internationally acclaimed     Dance for Parkinson's Disease (PD)®. When a user activates Glass, participants can choose     from a variety of different exercises, like warm me up or balance me. Once selected, they     see the founder instructors of the Dance for PD® projected in front of them.      As a single site research study at Syracuse University, researchers are conducting the pilot     phase of the research project.      The purpose of the study is to investigate the impact of MTG on quality of life and motor     functions (i.e. balance, gait, fall efficacy). Participation in the study required three     visits to Women's Building in a period of four weeks and about 1-3 hours of the participant's     time at each visit. During the first visit, 1 participants reviewed the consent form,     completed Montreal Cognitive Assessment (MOCA) and if qualified participated in a     face-to-face interview. Participants were given survey package to fill out at home and were     given a week to complete all the paperwork. On the second visit, they returned the completed     survey package, were given physical assessments and were taught how to use Google Glass. The     participants left with Google Glass, log sheet, and survey package. After 3 weeks,     participants came to Women's Building for the last visit and the physical assessments were     repeated, followed by an exit interview.   "
5421|NCT03214913|"     To evaluate two different strategy of fluid resuscitation in sepsis patients   "
5422|NCT03214900|"     This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent     implantation with everolimus eluting stent will be include. The primary endpoint was the     correlation between the change (baseline vs. 1 week) in the number of circulating endothelial     progenitor cells and in cell functionality following an everolimus eluting stent implantation     with the grade of neointimal hyperplasia measured by optical coherence tomography   "
5423|NCT03214887|"     The purpose of this study is to evaluate the safety and efficacy of hyaluronan combined with     autologous bone marrow mononuclear cells for the treatment of critical PAOD patients.   "
5424|NCT03214874|"     The study will evaluate the within-subject variability of 20mg ER torsemide as compared to     20mg IR torsemide (Demadex) in fully replicate double-crossover trial in healthy volunteers,     who are consuming a high-salt diet (300 mmol/day). The study will also evaluate the effects     of ER torsemide and IR torsemide on 24h sodium excretion and total urinary excretion.   "
5425|NCT03214861|"     This is an analysis conducted in the Nurses Health Study and the Health Professional     Follow-Up Study, both prospective cohort studies, where the investigators systematically     investigated the association between carbohydrate quality using a variety of metrics in     relation to coronary heart disease. This was a secondary data analysis of previously     collected data in both cohorts.   "
7812|NCT03183622|"     This is an open-label follow up study to evaluate the safety for the subjects with     ALLO-ASC-DFU treatment in phase 1 clinical trial(ALLO-ASC-BI-101) for 23 months.   "
5432|NCT03214770|"     This is a randomized clinical study. 48 subjects with a confirmed diagnosis of deep carious     molars without pulpal lesions were randomized to one of two treatments: Patients treated with     Light-cured calcium silicate (Theracal) liner, or treated with light-cured calcium Hydroxide     (Biner LC) liner. Both two Treatments are with the step-wise excavation Technique.      Treatment will be done at baseline, collecting dentin sample before application of liner     material, then patients will be dismissed with Resin-modified Glass Ionomer restoration and     recalled after 6 months. Re-entry of tooth required for completing the step-wise excavation     technique collecting the second dentin sample after this time interval (6 months) and     permanently restore tooth with composite restoration. Dentin samples will be     microbiologically analyzed and the results will be statistically calculated.   "
5938|NCT03208179|"     This study evaluates the efficacy and safety of monthly intermittent preventive treatment     using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ)     compared to sulphadoxine-pyrimthamine (SP) for the prevention of malaria in pregnant women in     the second and third trimester.   "
5433|NCT03214757|"     Dilated cardiomyopathy is a heart muscle disorder characterized by systolic dysfunction and     dilation of the left or both ventricles.Dilated cardiomyopathy can develop in people of any     age or ethnicity, although it is more common in male than female persons occurring at a ratio     of about three to one in male to female persons.      Dilated cardiomyopathy is the predominant cause of cardiomyopathy in pediatric populations.     Annual incidence in pediatric populations has been reported to be much lower than one to one     hundred seventy thousand in the United States and one to one hundred forty thousand in     Australia.      Although pediatric dilated cardiomyopathy has a lower annual incidence than adult dilated     cardiomyopathy, the outcome for pediatric dilated cardiomyopathy patients is particularly     severe.      Dilated cardiomyopathy is the most frequent cause of heart transplantation in pediatric     patients. Data from international pediatric dilated cardiomyopathy registries indicate that     the rates of death or heart transplantation over one and five year periods were thirty one     percent and forty six percent, respectively.      Onset of dilated cardiomyopathy is usually insidious but may be acute in as many at twenty     five percent of patients. Approximately fifty percent of patients with dilated cardiomyopathy     have a history of preceding viral illness.   "
5434|NCT03214744|"     Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants   "
5435|NCT03214731|"     This is a multi-center, randomized, double-blind, placebo-controlled study. Study subjects     are class III, IV, V, III+V, IV+V lupus nephritis patients, according to ISN/RPS 2003     classification of LN, with active lesion needing corticosteroid in combination with     immunosuppressant therapy.      Subjects who meet the eligibility criteria during screening will be randomized to 1 of 3     treatment groups in a 1:1:1 ratio: 25mg bid artesunate, 50mg bid artesunate or placebo plus     standard of care (prednisone plus mycophenolate mofetil ［MMF］) for 6 month.   "
5436|NCT03214718|"     The suppression of the immune system creates a permissive environment for development and     progression of cancer. One population of immunosuppressive cells that have become the focus     of intense study is myeloid derived suppressor cells , immature myeloid cells able to induce     immune-escape, angiogenesis, and tumor progression. Two different subpopulations have been     identified and studied: granulocytic and monocytic myeloid derived suppressor cells with a     different immunophenotype and immunosuppressive properties   "
5437|NCT03214705|"     Prospective evaluation of patients with subarachnoid hemorrhage (SAH) will be done by     computed tomography angiography (CTA) and perfusion imaging (CTP) for any correlation between     degree of vasospasm and perfusion deficit as well as evaluating the ability of CTP to predict     delayed cerebral ischemia.   "
5438|NCT03214692|"     Oxidative processes increased in patients with renal failure and especially patients with end     stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on     cardiovascular disease, atherosclerosis, which can accelerate renal damage. Gum Arabic is     claimed to have antioxidant effect and this will decrease the harmful effect of the free     radical on patient on hemodialysis. In this study investigators are aiming to see the effect     of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular     hemodialysis.   "
5439|NCT03214679|"     The proposed study will examine the feasibility, acceptability, safety, effectiveness, and     cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID)     in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs     designed specifically for PWID where they can comfortably access care without fear of shame     or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider,     together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle     exchange program. The proposed study will compare the effectiveness of Accessible Care with     Usual Care (referrals to existing services) in facilitating linkage, engagement, and     retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome     is sustained virologic response, which constitutes virologic cure. Substance use and HIV and     HCV risk behaviors are secondary outcomes.   "
5440|NCT03214666|"     This is a single center phase I/II clinical trial of CD16/IL-15/CD33 (161533) tri-specific     killer cell engager (TriKE) for the treatment of CD33-expressing high risk myelodysplastic     syndromes, refractory/relapsed acute myeloid leukemia or other CD33+ myeloid malignancies.     The hypothesis is that 161533 TriKE will induce natural killer cell function by targeting     malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to     tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK     cells, this single agent may induce a targeted anti-CD33+ tumor response.   "
5441|NCT03214653|"     This study aimed to compare the effect of target-controlled infusion of propofol and     sevoflurane as maintenance of anesthesia to intraoperative hemodynamic profile of renal     transplant recipient   "
5442|NCT03214640|"     We hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of     identifying epidural and/or intrathecal spaces as compared to conventional palpation method.   "
5491|NCT03214003|"     This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial.     In order to establish whether the SIB technique can improve the results of twice-daily     chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of     patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB     twice-daily RT or standard dose twice-daily RT.   "
5570|NCT03212976|"     This study is designed to evaluate the accuracy of a non-invasive method phase-contrast     magnetic resonance imaging (MR-ICP) for assessing intracranial pressure (Phase 1).      To perform second phase contrast imaging to evaluate the patency and flow of ventricular     catheters after MR-ICP imaging (Phase 2).   "
5501|NCT03213873|"     This project aims to determine the effects of the HiBalance program on neuroplastic changes     in people with mild to moderate Parkinson´s disease. The main hypothesis is that highly     challenging exercise will lead to greater gait and balance ability, increased levels of     physical activity and an improved health related quality of life. The investigators further     hypothesize that neuroplasticity changes will be seen in corresponding areas of the brain,     neuropsychological changes on cognitive test measures, and that exercise will inhibit the     degeneration of dopaminergic neurons in the brain through the mediation of neurotrophic     factors.   "
5949|NCT03208023|"     This study aims to evaluate the effect of a novel hemodynamic management and monitoring     strategy for reducing cardiac bio marker elevations and major adverse cardiac events.   "
5443|NCT03214627|"     Fresenius Medical Care has developed a computer software programme called the Anaemia Control     Management (ACM) software to assist in the anaemia management of patients with chronic kidney     disease (CKD) undergoing hemodialysis. This trial is designed to assess the effectiveness of     this ACM software on anaemia management in routine clinical practice. However, all ultimate     decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or     resource utilisation will be at the discretion of the Investigator. The trial consists of a     retrospective (historical) control period and a prospective (going forward) period. During     the prospective period, the ACM will be used to assist the Investigators' decision making and     will help the Investigators to administer a personalised intravenous (IV) iron and red blood     cell stimulating agent (ESA) therapy, whereas treatment according to standard of care will be     documented retrospectively for the same patients during the retrospective period of the     trial. Thus, patients can serve as their own control.   "
5444|NCT03214614|"     The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating     multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given     for 14 days in healthy male subjects.      The purpose of the study is to evaluate the safety and tolerability of multiple ascending     oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of     multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.   "
5445|NCT03214601|"     The purpose of this study is to conduct an early clinical evaluation of the Relay Branch     System, which will provide initial insight into the clinical safety and function of the     device.      This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at     the index procedure and at 30-day follow-up. The study will evaluate the delivery and     deployment of the device, patency of branches and branch vessels, and exclusion of the aortic     pathology. The data will help determine if modifications need to be made to the device, the     procedural steps, operator technique, or the indications for use.   "
5446|NCT03214588|"     The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper     extremity (arm and hands) motor function and manual dexterity. This study will also evaluate     the efficacy of TAK-831 versus placebo on Activities of Daily Living (ADL).   "
5447|NCT03214575|"     Background: Central venous catheter (CVC) insertion is a very common procedure in the     intensive care setting. A recent international guidelines advocated the use of ultrasound for     routine internal jugular CVC insertion. The needle navigation technology is a new innovation,     also known as guided positioning system (GPS) which allows clinician to visualize the needle     position and trajectory in real time as it approaches the target. We hypothesised that the     use of GPS would increase success rate and decrease performance time in vascular access     procedures.      Objectives: To compare the success, efficacy and safety of the procedure using the ultrasound     guidance (UG) with conventional versus GPS method.      Methods: This was a prospective randomized controlled study in a single centre - intensive     care unit. 100 patients were randomized into two groups (50 each each). Subjects would     receive CVC insertion via internal jugular vein using ultrasound guidance out of plane     approach by conventional versus GPS method. Outcomes measured were the procedure efficacy,     safety, level of operators' experience and their satisfaction.   "
5448|NCT03214562|"     The goal of this clinical research study is find the highest tolerable dose of venetoclax     that can be given in combination with a type of chemotherapy called FLAG-IDA to patients with     acute myeloid leukemia (AML). FLAG-IDA chemotherapy includes fludarabine, cytarabine,     idarubicin, and filgrastim.      The safety of this drug combination will also be studied.   "
5449|NCT03214549|"     The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain     laminates veneers prepared with modified gull wing preparation and conventional preparation.   "
5450|NCT03214536|"     In spine surgery postoperative pain can often be severe and difficult to treat.With the use     of ultrasound, the performance of plane blocks and other techniques like root blocks, facet     infiltration have become possible without the use of either unreliable  pop-techniques or     the use of x-ray.The erector spinae block was recently described as a safe and simple and     safe technique for neuropathic pain and acute post surgical pain, with effect on the dorsal     rami of the spinal nerves and with promising results. In this observational pilot study we     want to test the influence of these to blocks on the postoperative pain and opioid     consumption after spine fusion.   "
5451|NCT03214523|"     Sleep is a clearly necessary neurobiologic process that influences innumerable aspects of     basic daily functions, physical health, and mental well-being. Recent literature shows that     college students across the country are experiencing high rates of sleep deprivation.     Interestingly, some recent studies have implicated this sleep loss in contributing to weight     gain that occurs in the first year of college, also known as the freshman fifteen. Rates of     depression and other mental health issues, which are closely connected to sleep disturbances,     are also on the rise in college campuses. The majority of the sleep data obtained in this     population has been via questionnaires and self report, and the studies usually include     college students at all seniority levels (e.g., freshmen, sophomores, seniors). Here, the     investigators outline a novel study investigating how sleep time changes in college freshman,     and how it relates to multiple different aspects of their health and functioning over the     course of one quarter.      As technology has advanced, the ability to easily obtain objective measurements of different     health parameters has increased dramatically. The investigators plan to use wireless     actigraphy devices to measure sleep over a baseline seven day period in college-bound UCSD     students prior to matriculation, and for 2 additional seven day periods during the first     quarter of college. To the knowledge of the investigators, this is the first study to     directly measure sleep time in college freshman in their normal environment. Effects of sleep     time loss will be evaluated through multiple different metrics of physical and mental health.     Given the recent link between sleep disturbances and weight gain in college freshman, the     investigators will plan to measure weight changes prior to entering college and at two     different time points through the first quarter. The investigators will use the PSQ-9 and     GAD7 batteries as measures of mental health, obtained at the same time points as the sleep     and weight information. As one of the primary consequences of sleep deprivation is on     neurocognition in the daytime, the investigators plan to measure vigilant attention using     psychomotor vigilance testing (PVT) as well. Screen time use has recently been targeted as a     possible contributor to sleep loss in adolescents as well as adults and is something the     investigators will attempt to measure as well using a smartphone application. Finally, this     project will test the efficacy of a one hour sleep education intervention on improving total     sleep time.      To the knowledge of the investigators, no other studies have closely examined how total sleep     time changes during the first year of college in freshman in relationship to weight and     mental health parameters, nor has PVT been done in this context. Additionally, with the     increasing concerns regarding screen time use in adolescents and young adults, this study     provides prime opportunity to examine this issue in the context of sleep.   "
5452|NCT03214510|"     The goal of this clinical research study is to compare the quality of recovery for patients     who receive different standard pain control treatments after surgery on the liver.     Researchers want to learn which method helps people to recover more completely and more     quickly after surgery.      The 2 kinds of pain control are epidural pain management and transversus abdominus plane     (abdominal) block.   "
5454|NCT03214484|"     This pathology, DMLA, whose evolution is chronic, requires regular follow-up and care (IVTs)     over a long period (several months or even years).      Increasing the number of patients to be followed and treated poses increasing problems for     ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory     functional results.      Moreover, this regular follow-up imposes enormous constraints on patients and their families     (some children or patients are still working).      Studies are beginning to emerge on the reliability of patient follow-up in telemedicine. The     use of a measure of visual acuity by patients, Electronic Tablet (TE) or computer (O), and at     home, seems a logical step to help us improve the quality of patient follow-up while spacing     controls.      The aim of our study is thus to demonstrate that the measurement of the VA performed by TE or     O is reliable. Indeed, during the follow-up of the patients, in the case where the patient's     AV decreases, and whatever the reason   "
5455|NCT03214471|"     The aim of this trial is to evaluate the effect of a post-surgery 12-month lifestyle     intervention compared to usual care upon post-surgery weight loss and changes that occur in     body composition (relative amounts of body fat, muscle and bone), physical fitness and     activity levels, diseases linked to obesity (e.g. diabetes, high blood pressure, high     cholesterol level, sleep apnoea) and health-related quality of life (HRQoL) over a 12-month     period.   "
5456|NCT03214458|"     The investigators are looking at the effect of humidified nasal high-flow with oxygen     (HNHF-O2) on air exchange during exacerbations of COPD. HNHF-O2 therapy may have beneficial     effects in patients with severe breathing impairment that results in low oxygen in the blood.     Some studies show that patients with low blood oxygen levels who use HFNC oxygen have lower     rates of needing mechanical ventilation.   "
5457|NCT03214445|"     the patient (n=60), with at least 3 composite resins with marginal defects , randomized into     3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin     sealant , and C=Control, without intervention , and then assessed by the FDI criteria for     clinical performance and longevity of restorations   "
5458|NCT03214432|"     Background:      Patients with mild traumatic brain injury can to some extend experience long-term physical,     cognitive, social and behavioral deficits, which have serious implications for employment     trajectories and financial independence. High socio-economic position such as income, level     of education or employment before the accident have shown to affect return to work.     Previously studies are typically self-report studies, and are often small and may suffer from     selection bias due to patient nonresponse.      Aim:      The aim of this study is to describe variations in return to work and social transfer     payments among patients with mild traumatic brain injury in Denmark on the basis of a range     of socioeconomic indicators.      Hypothesis:      The hypothesis is that patients with mild traumatic brain injury use more social benefits     compared to a non-injured control group, and additionally a greater proportion of patients     with mild traumatic brain injury with a low socio-economic position (low education, low     income, being single, ethnic origin other than Danish) use more social benefits than patients     with mild traumatic brain injury with a high socio-economic position.      Methods:      The present study is an observational retrospective national register-based cohort study with     long-term follow up of patients with mild traumatic brain injury from 2008-2012 in Denmark.     Patients aged 18-60 years diagnosed with concussion from 2003-2007 in the national patient     register will be included in the study. Data will be retrieved from several national     databases, including the DREAM database containing data on social benefits and     reimbursements. Primary outcome is return to work and secondary outcome are sickness absence,     long-term sickness absence and disability pension.   "
5459|NCT03214419|"     Radioisotopic and wire localizations suffer from several limitations. These techniques add     another procedure prior to surgery, can be uncomfortable and entail additional cost.      The aim is to develop a novel technique of breast tumor localization using preoperative     magnetic resonance imaging (MRI) and breast optical scanning.      Patients with diagnosis of breast cancer who have had a preoperative MRI and 3D optical scans     are included.      Optical scanning is done preoperatively and intraoperatively after tumor localization was     marked on the breast using radioisotopic technique.      The MRI is then adjusted with the intraoperative optical scan to match the breast position at     the time of surgery.      The investigators evaluate the efficiency for localization of breast lesion of the novel     technique by comparison with radiosiotopic technique.   "
5460|NCT03214406|"     Parallel, double blind, randomized, IRB-approved study involving approximately 160 subjects     to complete. Subjects were randomly assigned to either the test product (Arm & Hammer Advance     White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline     mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned     dentifrice 2X daily and were evaluated for gingivitis, bleeding and plaque at Baseline and     after 4-, 8-, and 12-weeks of product use.   "
5461|NCT03214393|"     Relation of certain maternal serum antibodies to Doppler changes will be studied in cases     suffering from hypertension with pregnancy.   "
5462|NCT03214380|"     The purpose of this study is to compare LY900014 to insulin lispro, both in combination with     insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).   "
5463|NCT03214367|"     The main purpose of this study is to evaluate the efficacy of the study drug LY900014     compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in     adults with type 1 diabetes (T1D).   "
5464|NCT03214354|"     The aim of this study to evaluate the safety and efficacy of a nonmyeloablative conditioning     regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric patients     with sickle cell disease (SCD) who have a matched related major ABO-incompatible donor. The     nonmyeloablative regimen will use alemtuzumab, total body irradiation (TBI) and sirolimus for     immune suppression. This study will expand the access of HSCT for patients with SCD who are     currently not eligible because of donor restrictions.   "
5465|NCT03214341|"     Differentiation between benign and malignant mediastinal tumors as well as characterization     and grading of malignancy which is essential for treatment planning as well as for prognosis   "
6030|NCT03206970|"     This is a single-arm, open-label, multi-center Phase 2 study in subjects with histologically     documented MCL who have no response or relapse after ≥ 1 but < 5 prior treatment regimen(s).     The study is composed of an initial screening phase, a single-arm treatment phase, and a     follow-up phase.   "
5466|NCT03214328|"     Intrauterine fetal death (IUFD) is defined as the occurrence of fetal death at >20 weeks'     gestation. IUFD affects about 1 in 160 pregnancies (6-7 per 1000 births). Optimal diagnostic     evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal     and fetal blood tests, fetal bacteriology, cytogenetic analysis, autopsy, and placental     examination. This extensive protocol testing may vary in clinical practice and interpretation     of the results is rarely performed by multidisciplinary staff to establish cause of death.     These findings are related to the fact that there are very few epidemiological studies to     validate optimal protocol, no French recommendations on this subject, and a relative lack of     pathologists with expertise in perinatal pathology. Only, one recent prospective study from     the Netherlands has concluded that extensive protocol testing should be redefined and some     diagnostics tests may only be performed with suggestive clinical circumstances. However these     recommendations may not be applicable to all populations and countries. To date, there are no     French published series on IUFD to evaluate causes of death in France and thereafter to     better define optimal diagnostic evaluation tests. Improvement in prenatal diagnosis in     France may contribute to detection of the vast majority of severe chromosomal abnormalities     and malformed fetuses and particularly those at risk of death. Retrospective cohort     unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to     chromosomal or malformation abnormalities. In fact in these two series, most deaths were     related to placental diseases or fetal growth retardation. The hypothesis is that extensive     protocol testing is not helpful in clinical practice and selective protocol testing focused     on specific risk situations can be as efficient.   "
5467|NCT03214315|"     The project aims at developing and structuring a network of clinicians, pathologists, and     scientists, from the Grand Ouest area, most of them already involved in prostate cancer     management and research.      Patients treated by radical prostatectomy will be recruited within the ReSCaP network of     clinicians, with centralized database and standardized bio-resource collection, including     prostate and adipose tissue samples. Seven clinical centers will participate to the network,     6 recruiting mainly Caucasian patients, and 1 from the French West Indies recruiting mainly     African Caribbean patients. After 18 months, 1000 patients will be included.      The main goal is to study the relationships between adipose tissue/lipids and prostate cancer     aggressiveness. In fact, adipose tissue is likely to be involved in cancer progression at     many levels: abdominal obesity has been associated with aggressive disease, and     poly-unsaturated fatty acids (PUFAs), as well as cytokines produced by adipocytes     (adipokines) have an impact on cancer cells growth and migration in vitro. Moreover, adipose     tissue is the preferential site of storage of persistent organic pollutants with estrogenic     properties, which could impact cancer progression.      The study will analyze the association between adipose tissue (distant from the prostate)     composition and cancer aggressiveness. Among the 1000 patients, 100 aggressive tumors will be     selected according to the d'Amico criteria (Gleason score 8 or more and/or pT3 tumors). They     will be matched with 100 potentially indolent prostate cancers (Gleason 6 or less, and PSA     less than 10, and pT2 stage on the surgical specimen). These 200 adipose tissue samples will     be analyzed for 1/ the lipid profile, including the fatty acid composition, particularly     PUFAs, that reflects past dietary fat intake, 2/ adipokine expression, and 3/ tissue     concentrations of persistent organic pollutants belonging to the class of organochlorine     pesticides with hormone-like activity.   "
5468|NCT03214302|"     The majority of childbearing age women with hepatitis B virus infection were still in the     immune tolerance period. Our recent research had shown that most puerperae after delivery had     elevated ALT level. However, there is no withdrawal time recommendations after childbirth at     present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the     investigators explore the withdrawal time of antiviral treatment during pregnancy.   "
5469|NCT03214289|"     The investigators hypothesize that perturbations in the intestinal microbiota following     allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development     and propagation of acute graft-versus-host disease. Therefore, modification of HSCT     recipients' gut microbiota using fecal transplantation from a healthy donor could be used to     treat gut acute GVHD.      The study evaluates safety and feasibility of fecal microbiota transplantation with frozen     capsules from healthy donors for the treatment of steroid resistant or steroid dependent     acute graft-versus-host disease of the gut.   "
5470|NCT03214276|"     Endurance performance during high intensive exercises is mainly determined by the capacity of     the aerobic metabolism. It generally induces muscle fatigue defined as the reversible decline     in skeletal muscle contractile performance. Fatigue is multifactorial and is often associated     with many physiological parameters including reduced neural input and disruptive metabolic     changes in skeletal muscles such as lactic acidosis and the production of oxidative free     radicals. Moreover, it could lead to oxidative stress as a result of an imbalance between     reactive oxygen species (ROS) production and intrinsic antioxidant defense.      To alleviate oxidative stress, some ergogenic strategies have been tested. Numerous studies     have reported that different types of supplementation such as selenium, vitamin E, vitamin C     or polyphenols were of interest to protect against these mechanisms. Indeed, although some     studies demonstrated no or harmful effects, most studies observed positive effects of     antioxidants on oxidative stress or performance. More particularly, polyphenols, have great     antioxidant capabilities and protective effects and it increases the synthesis and     bioavailability of nitric oxide (NO)which is well known to be the most important mediator of     vasodilation. To date, most of the studies exploring the effects of polyphenols on exercise     investigated several days or weeks of supplementations on vascular, blood parameters (blood     pressure, NO concentration, oxidative stress markers) or endurance performance. Conflicting     results are often obtained. Only few studies investigated the effects of a single intake on     immediate performance and recovery capacity. Therefore, the present work aimed to study the     effects of an acute intake of a specific profile polyphenols from grape and apple on physical     performances. More specifically, performance, in the present study, referred to high     intensity cycling exercise until exhaustion revealing the capacity to maintain a constant     strong effort hereafter named endurance. The hypothesis was that an acute of polyphenols     would increase the time to exhaustion during a high intensity cycling exercise.   "
5471|NCT03214263|"     Introduction: The medical treatment of inflammatory rheumatic diseases has improved     dramatically during the last decades primarily due to the introduction of biological disease     modifying anti-rheumatic drugs (bDMARDs). However, bDMARD treatment failure occurs in 30-40%     of patients due to lack of effectiveness or side effects. The tools to predict treatment     outcomes in the individual patient are currently limited. The objective of the present study     is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1)     diagnose inflammatory rheumatic diseases early in the disease course with high specificity     and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and     tolerability for the individual patient.      Methods and analysis: Observational and translational open cohort study with prospective     collection of clinical data and biological materials in patients with inflammatory rheumatic     diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e.     whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are     enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after     0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities     and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected     repeatedly during follow-up. Currently (June 2017) >5,000 samples from ≈3,000 patients have     been collected. Data will be analysed using appropriate statistical analyses.      Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The     Danish Data Protection Agency. All participants give written informed consent. Biomarkers     will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results     will be published in peer-reviewed medical journals and presented at international     conferences.   "
5472|NCT03214250|"     The main purposes of this study are to learn how effective the study drug combinations are in     treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are     APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.   "
5473|NCT03214237|"     To provide a point-in-time measurement of the oral health of elderly inpatients across the     trust (elderly defined here as over 70 years). This will provide information about the number     of teeth, need for restorative and periodontal treatment, and extractions, the health of the     oral mucosa, quality of any dentures and hygiene of the teeth and dentures.   "
5477|NCT03214185|"     50%-60% of the known causes of recurrent pregnancy loss(RPL) are associated with embryonic     aneuploidy, such that preimplantation genetic screening (PGS) on embryos acquired by assisted     reproductive treatment should improve the rate of pregnancy and live birth in those patients.     In dispute though the clinical application of PGS has been, a series of studies show that the     new generation of PGS(PGS 2.0), based on blastocyst biopsy followed by whole genome analysis,     has significantly improved the clinical outcome of IVF treatment. At present, there is still     a need for the evidence of the use of PGS 2.0 in RPL patients, who may benefit from this     emerging technology considering the prevalence of genetic abnormalities and the number of     transferable embryos in this population.      An earlier single center RCT conducted by our IVF center displayed higher implantation rate,     clinical pregnancy rate and ongoing pregnancy rate calculated by per embryo transfer(ET)     cycle in IVF/ICSI+PGS group compared with IVF/ICSI group.      This multi-center prospective randomized clinical trial is to provide more data to determine     whether the clinical outcomes are significantly improved per treatment cycle such that     provide evidence for the application of PGS in RPL patients. Besides, risk factors of PGS     outcome are to be analyzed from multi-center data to build a model for prediction of the     possible outcomes of PGS and direction of the clinical choice.   "
5478|NCT03214172|"     To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding     and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with     rivaroxaban   "
5479|NCT03214159|"     The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir     tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting     condition.   "
5480|NCT03214146|"     The purpose of this study is to evaluate the safety and efficacy of HLA-haplo matched     Allogenic Bone Marrow Derived stem cells(HYNRCS-Allo-ALS-02 inj), through intrathecal     delivery for the repeated treatment after 6 months of first treatment in patients with     amyotrophic lateral sclerosis(ALS).      This study is an open label, single-dose study to assess the safety and efficacy of HLA-haplo     matched Allogenic Bone Marrow Derived stem cells(HYNRCS-Allo-ALS-02 inj)   "
5481|NCT03214133|"     This study will investigate the effects of dietary supplementation of epicatechin-rich cocoa     in humans on collagen synthesis and power-based performance outcomes (rate of force     development).   "
5482|NCT03214120|"     The study is to evaluate the effect of modified ultrafiltration on different components of     Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary     bypass.   "
5483|NCT03214107|"     To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate     intake is frequently required. Carbohydrate intake required will vary with insulin regimens,     timing and type of exercise as well as starting blood glucose level. In addition to the     amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact     on glucose control during exercise. Therefore, the objective of this study will be to compare     the efficacy of two snacking strategies to maintain glucose levels in the target range during     an exercise period in adults with type 1 diabetes: 1) a snack containing ~0.5g of     carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes     before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight -     rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30%     after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.   "
5484|NCT03214094|"     The purpose of this study is to investigate the safety and efficacy of long-term     administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine     clinical setting in patients receiving low-dose aspirin.   "
5485|NCT03214081|"     The purpose of this study is to evaluate the safety and efficacy of long-term administration     of Vonoprazan tablets (Takecab tablets) when used as maintenance therapy for reflux     esophagitis in routine clinical settings.   "
5486|NCT03214068|"     The study on evaluation the pattern of TD in MetS population may help us to know the     magnitude of overlap of these two disease entities and may highlight the importance of     thyroid function tests in patients with MetS. This can lead to proper planning and adequate     management strategies, resulting in significant reduction in cardiovascular morbidity and     mortality due to MetS with TD. Thus, this study aims to evaluate the pattern of TD in     patients with MetS and to explore the relationship between TD and components of the MetS.   "
5487|NCT03214055|"     We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial     pressure before and after mannitol administration in patients who undergo robot assisted     laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.   "
5488|NCT03214042|"     To conduct a prospective, single-center, self-controlled, clinical trial to verify the     efficacy and safety of K-Rod dynamic stability system in the repair of lumbar degenerative     diseases following 2 years follow-up, aiming to provide references for clinical treatment of     lumbar degenerative diseases.   "
5489|NCT03214029|"     Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the     diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the     emergency department in whom serial cTnI measurements are obtained on clinical indication.   "
5490|NCT03214016|"     This study evaluates the effects of Pilates method and aerobic training in hypertensive     subjects. Half of participants will be trained with Pilates, while the other half will be     trained with aerobic exercise during 8 weeks.   "
5502|NCT03213860|"     Environmental factors such as noise and light have been cited as important causes of sleep     deprivation in Intensive care unit (ICU) patients. Previous studies demonstrated a     hyperalgesic alteration in pain perception following a controlled sleep deprivation protocol.     Another studies indicated that using eye masks can improve REM sleep in healthy subjects in     simulated ICU environment, and improve sleep quality in ICU patients. This study aimed to     determine the effects of using eye masks on sleep and thus on pain quality in postoperative     cardiac surgery patients in ICU.   "
5611|NCT03212443|"     Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve     block adding to general anesthesia might improve the quality of postoperative analgesia. The     aim of the study is to compare the subacromial local anesthetic infiltration and the     suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption,     postoperative analgesia and analgesic consumption.   "
5492|NCT03213990|"     The purpose of this study is to find out whether continuous infusion of beta-lactam     antibiotics or intermittent infusion or beta-lactam antibiotics, offers more health     advantages to patients or if there is no difference.      The investigators will be looking to see whether patients receiving beta-lactams via one     administration method or the other have a better chance of recovering from their illness.     They will also be looking at long term outcomes such as quality-of-life and healthcare     resource use.      Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the     bloodstream from a site of infection. In some people, the infection can progress to sepsis     and septic shock where the functions of organs in the body are affected. Patients suffering     from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they     are prescribed antibiotics as standard therapy, as well as other therapies to support the     functions of the body.      Beta-lactam antibiotics are a group of antibiotics commonly used to treat infection in     patients with sepsis and septic shock.      Currently, beta-lactam antibiotics are most commonly given to patients be intermittent     infusions, that is, given at regular intervals throughout 24 hours. New research suggests     that giving beta-lactam antibiotics as a continuous infusion may mean that antibiotic     concentrations in the blood remain more consistent and may be more effective at killing     bacteria.      However, the benefit to the patient by giving beta-lactams via continuous infusion has not     been tested in a high-quality, large clinical trial.   "
5493|NCT03213977|"     Patients initially are randomized into 4 arms:      Arm I: R-DA-EPOCH; Arm II: R-DA-EPOCH + auto-SCT; Arm III: R-CEOP90; Arm IV: R-CEOP90 +     auto-SCT.      Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of     R-DA-EPOCH or R-CEOP 90, continue to have 2 more cycles for consolidation in each arm (Arm I     and Arm III), or undergo stem cell harvest and auto-HSCT following standard institutional     protocols. (Arm II and Arm IV).      The overall purpose of the study is to determine if R-CEOP90 followed by auto-HSCT has     similar efficacy compared to that with R-DA-EPOCH.   "
5494|NCT03213964|"     This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose     (MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with     recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following     minimal prior treatment requirement:        -  Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy).          Platinum resistant is defined as disease that has responded to initial chemotherapy but          demonstrates recurrence within a relatively short period of time (< 6 months) following          the completion of treatment.        -  Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy).          Platinum sensitive is defined as the recurrence of active disease in a patient who has          achieved a documented response to initial platinum-based treatment and has been off          therapy for an extended period of time (≥ 6 months).   "
5495|NCT03213951|"     68Ga-PSMA is a radiopharmaceutical used with PET imaging for the detection of prostate cancer     under a compassionate IND in patients who have presented with biochemical failure. In this     study, the use of 68Ga-PSMA-11 will be extended to newly diagnosed patients with high risk     prostate cancer. Patients enrolled to this study will undergo a 68Ga-PSMA-11 PET/CT or     PET/MRI scan for research purposes (in addition to the routine CT or MRI that is routinely     done for staging), and a second 68Ga-PSMA-11 administration just prior to surgery for     experimental ex-vivo beta probe testing of resected tissue. Immediately following resection     of the prostate, the intact tissue will be scanned using a PET camera designed for animal     research in order to record the 68Ga-PSMA-11 distribution in the isolated tissue at higher     resolution than can be attained using whole-body PET imaging. The experimental beta probe     will then be use to measure 68Ga-PSMA-11 counts of the resected tissue.   "
5496|NCT03213938|"     Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of     bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS     include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It     affects men of all ages without apparent racial predisposition, among which, 36-50 years old     are the most commonly influenced. Yet, few effective therapies are available for treating     CP/CPPS.      Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture     on CP/CPPS remain uncertain because of the small sample sizes or other methodological     limitations.      The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to     assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will     provide a robust conclusion with a high level of evidence.   "
5497|NCT03213925|"     After neoadjuvant chemotherapy, patients normally receive either conservative breast surgery     or mastectomy followed by radiation therapy. Some patients achieve a complete response after     neoadjuvant chemotherapy. Considering that radiation therapy is an effective treatment for     subclinical microscopic disease, the question arises whether breast surgery before radiation     therapy can be avoided in the subgroup of patients with complete response after neoadjuvant     chemotherapy.   "
5498|NCT03213912|"     The investigators determine the half maximum effective concentration (EC50) of the Cet value     of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for     the maintenance of general anesthesia during microelectrode recording in the deep brain     surgery in patients with Parkinson's disease.   "
5499|NCT03213899|"     Previous studies have demonstrated the direct associations between malnutrition and hospital     mortality as well as the length of stay in critically ill patients. However, the validity of     these results may be limited by inappropriate diagnoses of malnutrition, small sample size,     possible treatment bias, and sub-optimal statistical adjustment. This study aimed to further     examine the aforementioned associations by addressing these limitations.   "
5500|NCT03213886|"     This study will be done to evaluate the effect of load dose of vitamin D compared to the dose     of usual clinical practice, in improving mobility and reducing disability in older people     following a hip fracture.   "
5540|NCT03213366|"     The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy     of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV     infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health     intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV     prevention and to increase linkage to primary care.   "
5612|NCT03212430|"     To measure the cerebral hemodynamic effect of L-kynurenine.   "
5503|NCT03213847|"     The aim of the study was to determine whether there is a correlation between the increased     intraneural flow as measured using Doppler ultrasound (US) and superb microvascular imaging     (SMI) methods and the severity of CTS as measured by nerve conduction studies. Moreover,     investigators investigated the association of increased intraneural flow with the cross     sectional area of the median nerve. The null hypothesis that there is no correlation between     increased intraneural flow and the severity of carpal tunnel syndrome.   "
5504|NCT03213834|"     The purpose of this prospective randomized clinical trial is to compare two currently     accepted standard-of-care treatment strategies: medical thoracoscopy as compared to     instillation of intrapleural tissue plasminogen activator (TPA) and human recombinant     deoxyribonuclease (DNase) for the management of complicated pleural infections in adults as     defined as complicated parapneumonic effusions or pleural empyema.   "
5505|NCT03213821|"     Effect of high calorie high protein diet versus high calorie,glomerular filtration rate (GFR)     based protein intake in non-obese advanced HF patients will be assessed. In this regard,     protein intake impact will be measured on muscle mass, physical performance and renal     function as main outcome. Rehospitalization, quality of life, depression an inflammatory     status are second endpoints.   "
5506|NCT03213808|"     Allergic diseases, including allergic asthma, allergic rhinitis and anaphylaxis are not     properly classified in current classifications of diseases. We here propose a project based     on the evaluation of medical records of hospital databases of patients suffering for allergic     and hypersensitivity conditions coded with the current and a new coming version of the     international classification of diseases, no patient or intervention will be analysed.      We here propose a study to update and reach quality assurance of the classification of     allergic and hypersensitivity conditions in international classification systems. The     Allergic and hypersensitivity conditions section has indeed been recently built into the new     ICD-11 framework and we aim to reach its quality assurance by evaluating medical records of     French hospital databases. All the consecutive cases related to allergic and hypersensitivity     conditions registered in the last 1 year will be selected and blind-coded by two independent     coders based on the online English versions of the ICD-10 (2015 version) and ICD-11 Beta     draft. The generated data will support the intra and inter-variability testing, survey among     end-users and economic-impact evaluation. The economic impact of the transition from ICD-10     to ICD-11 will be analysed based on average estimated cost per day of each principal     diagnosis and the effect of the classification change will be quantified by the cost variance     of inter or intra diagnosis of ICD-10 and ICD-11. For the bridge procedure based on the     alignment of the allergic and hypersensitivity conditions described into the ICD-10 (and     ICD-10 CM US adaptation) framework to the ICD-11 beta phase, we propose the mapping and     cross-linking terms methods. Meanwhile, we will start updating the allergic and     hypersensitivity procedures by influencing the International Classification of Health     Intervention (ICHI).   "
5507|NCT03213795|"     Since the development of multibranched endografts a novel therapeutic option for the     management of thoracoabdominal and para-renal aortic aneurysms was made accessible. The     introduction of readily available off-the-shelf devices expanded the application of such     technology also to those patients who could not afford to wait for a customized endograft to     be designed and manufactured according to their aneurysm morphology   "
5508|NCT03213782|"     Effect of nature based sounds' intervention on Agitation and Anxiety of patients admitted in     Intensive Care Units of MMIMS&R Hospital, Mullana, Ambala   "
5509|NCT03213769|"     Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause     is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10     gel to treat the lesion and more safe for the participants.   "
5510|NCT03213756|"     A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with     autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and     complications. The distal forearm AVF is known as the best option but not all patients are     good candidates for this surgery, and there is a primary failure rate between 20 and 50%     published in literature.      The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and     hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis.     These characteristics can be modified by performing physical exercise Some vascular access     guidelines suggest the performance of isometric exercises in the pre and postoperative period     of the AVF confection. However, there is very little data in literature on the possible     efficacy of preoperative exercise, although small published observational studies point to an     improvement in the venous and arterial caliber. Regarding the postoperative exercises, they     do seem to improve maturation, however the degree of evidence in literature is low and there     is no consensus on the exercise protocol to follow.      We present an open-label, multicenter, prospective, controlled and randomized study in order     to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients     or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1,     one group of patients will perform PIE for 8 weeks and the other group of patients will be a     control group. The main purpose will be to evaluate if there is a lower rate of primary     failure in the PIE group compared with control group.   "
5511|NCT03213743|"     The purpose of the study is to find out the differential expression profiling of microRNA     before and after adiministration of dexmedetomidine in patients undergoing procedures, and     then investigators will do some in vitro studies to validate the functions of the microRNA.   "
5512|NCT03213730|"     This study is part of a larger, multi-centered project done with the collaboration of     University Of Victoria. This study holds three separate studies on the mild traumatic brain     injured population and the use of perceptual-cognitive training (3D-MOT).   "
7717|NCT03184870|"     This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy     of BMS-813160 in combination with either chemotherapy or nivolumab in participants with     metastatic colorectal and pancreatic cancers.   "
5533|NCT03213457|"     The objective of this study is to evaluate safety and efficacy of elagolix in the management     of moderate to severe endometriosis-associated pain in adult premenopausal female subjects     including the safety and efficacy of elagolix in combination with concomitant hormonal     add-back therapy.   "
5534|NCT03213444|"     The present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated     and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent     vascular function in patients undergoing colectomy for stages II and III colon cancer. Will     be performed evaluation of cardiac and vascular function, autonomic control, functional     capacity and blood evaluations.   "
5561|NCT03213093|"     Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes.     Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin     vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular     component and abnormal foot plantar pressure are also important to take into account. The aim     of the study is to assess prospectively different factors involved in DFU pathogenesis     notably the neurovascular response to non noxious pressure.   "
5513|NCT03213717|"     Title: Effect of body weight loading on urinary electrolyte excretion      Swedish Title: Effekt av belastning på utsöndring av elektrolyter      Study period: Q2-Q3 2017      Study site: The study will be performed at the Institution for Neurology and Physiology,     Sahlgrenska Academy, University of Gothenburg. Principal Investigator is John-Olov Jansson,     MD, PhD, Professor at Institute of Neuroscience and Physiology, University of Gothenburg      Background and study design: Weight reduction can be obtained by decreased appetite or     increased metabolism. However, acute weight loss can also be obtained by loss of fluids - for     example by increased urinary loss of fluid and salts, so called elctrolytes. Preliminary     results from a laboratory lesson for the Master of Science in Medicine program at University     of Gothenburg suggest that carrying a 10 kg weight vest could increase urinary excretion of     Na+, K+ and Cl-. The purpose of this study is to investigate this further in a more     controlled research setting. If confirmed, the results could potentially contribute to the     development of potent diuretics or obesity medicines.      The study will include 15 healthy volunteers and consist of three study days with about one     week between each study day. The study subjects will go through a different study procedure     each study day, and a randomized cross-over study design will be used to determine which     procedure each day.      Procedure 1: Wearing a weight vest with 10 % of body weight standing for seven hours. The     study subject is allowed to sit for 10 minutes each hour. The reason for this is that it has     been considered that the effect may be transmitted by weight loading of the lower     extremities.      Procedure 2: Wearing a weight vest with 1 % of body weight standing for seven hours, as a     control for procedure 1, with lower loading. The study subject is allowed to sit for 10     minutes each hour.      Procedure 3: Wearing a weight vest with 1 % of body weight sitting for seven hours. This is a     procedure with even less loading of the lower extremities than during procedure 2.      Urine- and blood samples, as well as heart rate and blood pressure measurements, will be     collected during the study days and analyzed in order to address the primary and secondary     objectives of the study.   "
5514|NCT03213704|"     This phase II trial studies Trk inhibitor LOXO-101 in treating patients with solid tumors,     non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other     places in the body and have come back or do not respond to treatment. Trk inhibitor LOXO-101     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
5515|NCT03213691|"     This phase II trial studies how well selumetinib works in treating patients with solid     tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations     that have spread to other places in the body and have come back or do not respond to     treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
5516|NCT03213678|"     This phase II trial studies how well PI3K/mTOR inhibitor LY3023414 works in treating patients     with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR     mutations that have spread to other places in the body and have come back or do not respond     to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.   "
5517|NCT03213665|"     This phase II trial studies how well tazemetostat works in treating patients with solid     tumors, non-hodgkin lymphoma, or histiocytic disorders that have spread to other places in     the body and have come back or do not respond to treatment and have EZH2, SMARCB1, or SMARCA4     gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
5518|NCT03213652|"     This phase II trial studies how well ensartinib works in treating patients with solid tumors,     non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have     come back or do not respond to treatment and have spread to other places in the body.     Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
5519|NCT03213639|"     Pre-eclampsia is one of the most serious complications of pregnancy affecting 3-8 % of     pregnancies worldwide. It is a multi-system disorder involving maternal vessels (causing     hypertension and endothelial dysfunction), the kidneys, the liver, the lungs, the     hematological system, the cardiovascular system and the feto-placental unit. In its most     severe form, it affects the brain, causing seizures (eclampsia), cerebro-vascular events and     even death.   "
5521|NCT03213613|"     This project will evaluate the neuro-cognitive outcomes of a novel, adaptive attention     training in a healthy adolescent population.   "
5522|NCT03213600|"     Social cognition concerns the understanding of how people think about others and how that, in     turn, influences our behavior, feelings, and social interactions. schizophrenia     social-cognitive impairment is profound (effect size D>1.2), medication resistant and     critically limits functional well-being . Social cognition involves complex patterns of     coordinated activity within numerous cortical and subcortical networks, making it a difficult     target for clinical neuroscience investigation. Yet, prior research demonstrates that     sensory-perceptual dysfunction in schizophrenia can upwardly generalize into higher-order     social-cognitive impairment making perception a tractable and fruitful approach for studying     social cognition in schizophrenia. Here, the investigators explore how distortions in     perception of temporal coincidence can contribute to the aberrant inferences of physical     causation and social agency.   "
5523|NCT03213587|"     To evaluate the efficacy and safety of apatinib in treating patients with recurrent or     metastatic nasopharyngeal carcinoma who failed prior platinum based chemotherapy   "
6056|NCT03206801|"     This is a Phase II-III multi-center prospective randomized controlled clinical trial of     incident adult renal transplant patients.      The primary objective of this study is to determine if the early treatment of rejection, as     detected by urinary CXCL10, will improve renal allograft outcomes.   "
5524|NCT03213574|"     Robot assisted urological procedures are often long surgical cases that can potentially     result in complicated postoperative hospital course. The amount of intravenous (IV) fluids     administered to patients during these operations fluctuates based on the length of the case,     surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The     goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing     fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid     status and analyze post-operative outcomes.   "
5525|NCT03213561|"     People with locked-in syndrome cannot move their limbs or talk because of a motor impairment,     but remain conscious and intellectually awake. Restoring the ability to communicate to people     with locked-in syndrome will have a positive effect on their quality of life, will enable     them to reintegrate into society and increase their capacity to lead productive and     fulfilling lives. This study sims to develop a new assisted communication device based on a     brain-computer interface, a system that allows the user to control a computer with his brain     activity. The investigators will develop this brain-computer system for long-term stability     and independent use by using adaptive decoders. The investigators will test the long-term     stability and independence of this system with healthy volunteers, people with tetraplegia     and people with locked-in syndrome over time periods of several months.   "
5526|NCT03213548|"     Rhinoplasty is among the most accomplished aesthetic procedures in Plastic Surgery. The     mastery of Alar Base modifications is essential for superior aesthetic results. The main     indication is to reduce nasal width when it exceeds the intercanthal distance in Caucasian     women. Other indications are the modification of the shape of the nostrils or to reduce alar     flare in noses with too convex alar base. Since Wier's first description, a series of     techniques has been developed with a common goal of making the basal view of the nose close     to an equilateral triangle. The location and amount of tissue to be removed will be according     to the preoperative or intraoperative indication due to changes in the alar base resulting     from reductions in the projection of the nasal tip. One of the controversies in the     literature is in the position of the incision in alar base modifications. Some authors     prioritize incisions that do not violate the alar facial groove , since the groove region     presents a greater number of sebaceous glands, leading to poor scarring results. Other     authors have argued that incisions above the sulcus have caused more evident scars, anda that     poor healing results would be more associated with aggressive resections of border and bad     closing skin techniques.      Due to divergence in the literature, the present study aims to compare, through a double     blinded randomized clinical trial, two techniques of alar base modifications that will     differentiate only by violating or not the alar facial groove.   "
5527|NCT03213535|"     This study aims to investigate the relation between the concentration of urea and creatinine     in vaginal fluid and length of latency period in women with PROM between 32 and 35 weeks     gestation.   "
5528|NCT03213522|"     The purpose of this study is to determine the efficacy of CST for the treatment of LUTS in     patients with MS and evaluate the acute effects compared to PFPT.      A. Objectives To examine the effect of CST as compared to PFPT on QOL, SEMG resting     biofeedback readings, and PVR ultrasonography measures in patients with MS and LUTS.      B. Hypotheses / Research Question(s) It is hypothesized that patients who receive CST will     demonstrate improved QOL, bladder control and ability to empty bladder as compared to those     who receive PFPT.   "
5529|NCT03213509|"     The purpose of this study is to conduct Verbal Autopsies of deaths (maternal deaths,     stillbirths and neonatal deaths together) identified in the BetterBirth trial to identify     their potential causes, timing, and social determinants.   "
5530|NCT03213496|"     Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to     conventional intervention (not recommended exercise) in reducing the length of hospital stay     and the time of onset of ambulation during postoperative hospitalization, in patients with     ability to move, ≥30 years who will undergo non-cardiac surgery.      Secondary        1. Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during          hospitalization.        2. Evaluate the incidence of falls during hospitalization.      Methodology The PAMP project phase II, as a component of CARDIECOL program will be     implemented by designing a pilot study, a randomized controlled trial. Adult-patients with     greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed     consent will be randomized to an intervention prescribed of walking in the period of 2-3     weeks before surgery or will be assigned to a Control group/conventional care. The study was     not blinded to patients, but evaluation and analysis of the data will be blinded for     researchers and statisticians. Patients will be evaluated on their previous level of physical     activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise).     This study will include a sample of 500 patients, with capacity to mobilize, ability to walk     at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to     be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of     stay, and time to first walk. Other results are evaluation falls during hospitalization and     the presence of falls, report of cardiovascular events, and death by group.      Expected results   "
5531|NCT03213483|"     The aim of this study will be to clinically assess the soft tissue augmentation achieved by     the de-epithelialized free gingival graft with coronally advanced flap versus the     subepithelial connective tissue graft with coronally advanced flap as root coverage     procedures for management of patients with Miller class I and II gingival recession.   "
5541|NCT03213353|"     This is a single-dose, randomized, two-period cross-over study with 72 healthy male and     female volunteers. The investigational products will be given (after fasting overnight) at     separate visits separated by 7 ± 3 days. Blood for pharmacokinetic analyses will be drawn     pre-dose and at 5, 10, 15, 20, 25, 30, 40, 60, 75, 90, 105 minutes, as well as 2, 2.25, 3, 4,     5, 6, 8, and 12 hours after drug administration. Subjects will also be monitored to capture     any adverse events that may occur. Bioequivalence will be assessed based on the single-dose     pharmacokinetics of paracetamol, guaifenesin and phenylephrine, respectively   "
5542|NCT03213340|"     This is a random order cross over design trial to evaluate the efficacy of select nutritional     ingredients on enhancing muscle perfusion in response to an acute meal stimulus.   "
17879|NCT03051503|"     to determine the safety, efficacy and tolerability of transdermal fentanyl in patients     undergoing mastectomy, as well as the postoperative consumption of analgesic.   "
5532|NCT03213470|"     Intracranial artery disease has been more detected with development of HR-MR. HR-MR can     depict vascular wall directly and give us more information beyond the pre-existing imaging     modalities such as digital subtraction angiography, magnetic resonance angiography, computed     tomography angiography. Hence, HR-MR is considered to become promising imaging modality for     intracranial artery disease and many studies have been published recently. However, there was     not enough to differentiate various intracranial artery disease such as atherosclerosis,     dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real     clinical arena, intracranial artery disease is too difficult to diagnose and distinguish     among the disease. Of the disease, usefulness of HR-MR has been consistently published in the     detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be the     most important and reliable imaging method in intracranial artery dissection as of now.     Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial     artery dissection is dynamic vascular pathology. The geometric change is the most common     among intracranial artery disease. However, there was no report about the geometric change in     HR-MR. We acquired retrospective data about the natural course of intracranial artery     dissection in HR-MR and are preparing for publishing an article. However, the data is not     prospective and not intraindividual comparison. Therefore, reliability is not enough to     convince the natural course. If we got prospective and intraindividual data, definite natural     course of intracranial artery dissection could be acquired and would be helpful to diagnose     the dissection and differentiate from other vascular pathologies. I'm sure that the     longitudinal information from this study could guide us as the important map on the confusing     HR-MR findings. In addition, our retrospective study can be a stepping-stone to perform a     prospective study, which can increase the success rate of the prospective study. The     protocols for imaging follow-up are as followed: initial (optional), 1 month, 3 month, 6     month (optional), 12 month   "
5613|NCT03212417|"     The purpose of this study is to evaluate the impact education has on reducing compassion     fatigue in Oncology Clinical Research Nurses.   "
5535|NCT03213431|"     This study will examine self-reported neurocognitive functioning in pediatric cancer     survivors whose cancer therapy may have included cranial radiation, intrathecal chemotherapy,     and high-dose intravenous antimetabolite chemotherapy. There is evidence that these therapies     which are directed at the central nervous system (CNS) can lead to reduced volumes of     normal-appearing white matter and neurocognitive dysfunction.      Neurocognitive deficits can significantly impact pediatric cancer survivors' academic     success, daily functional status, and quality of life. Previous studies demonstrate the need     for screening and treating neurocognitive dysfunction in childhood cancer patients and     survivors.      This pilot study will conduct cognitive debriefing tests with childhood cancer survivors, 30     with and 10 without neurocognitive deficits, and their parents. The collected data will aid     in developing a comprehensive patient-reported outcomes (PRO) toolkit consisting of generic     and specific cognitive and behavioral domains that are content-appropriate and     interface-friendly for pediatric cancer populations.      PRIMARY OBJECTIVE:        -  To conduct cognitive debriefing tests with 30 pediatric cancer survivors who have global          neurocognitive impairment (i.e., the impaired group) to understand the cognitive process          of answering the extant pediatric PRO measures by different levels of general          intelligence quotient (IQ). Additionally, 10 pediatric cancer survivors who have at          least average general IQ (i.e., the unimpaired group) will be recruited for a comparison          purpose.      SECONDARY OBJECTIVE:        -  To conduct semi-structured interviews with 30 parents/legal guardians of individuals who          have global cognitive impairment as described in the primary objective in order to          explore the general concept of their child's neurocognitive functioning, to rank the          relative importance of different neurocognitive functioning domains, to inform a          strategy for communicating with children and adolescents with impaired neurocognitive          functioning for PRO research, and to suggest a user-friendly interface to collect PRO          data from cognitively impaired children and adolescents. Additionally, 10 parents/legal          guardians of individuals at least average general IQ will be recruited for comparison.   "
5536|NCT03213418|"     This project aims to develop electroretinogram as a new putative marker for dopamine release,     and as a predictor of treatment response among patients seeking treatment for smoking     cessation. Tobacco smoking continues to be a major public health challenge. Dopamine is a     neurotransmitter released in the brain. Several lines of evidence suggest that dopamine     release deficit in the brain is involved in the development and maintenance of nicotine     dependence. The investigators hypothesize that smokers who do not have a deficit in dopamine     release will more readily respond to behavioral treatment for smoking cessation, and in     particular, financial incentives contingent on abstinence (Contingency Management). Previous     pilot data suggest electroretinogram (ERG), which records electrical signals from the retina     in response to light, is a clinically accessible correlate to dopamine release in the brain.     The project proposes an ERG-based biomarker, and a pilot clinical trial to apply this     biomarker to personalize smoking cessation treatment. This clinically tractable biomarker of     central dopamine release may have a large number of future applications in the diagnosis and     treatment of other mental illnesses and substance use disorders.      The study will recruit normal controls and smokers, measure ERG before and after a standard     dose of oral immediate release methylphenidate. Smokers will undergo a 12-week standardized     treatment course of CM. The investigators will test whether smoking status and the response     to CM are correlated to changes in ERG in response to methylphenidate challenge.   "
5537|NCT03213405|"     Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract     infection in children under one year of age. This study will evaluate the safety,     tolerability and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine that     expresses the human Respiratory Syncytial Virus Nucleoprotein (N), in adult males (18 to 50     years of age).   "
5538|NCT03213392|"     General anesthetic induced neurotoxicity has received considerable attention in the past     decade from various pre-clinical studies in rodents and non-human primates. Which     demonstrated that exposure to general anesthetic agents for a longer duration can induce     neuronal cell death that can lead to adverse neurodevelopmental outcomes.      The neuroapoptosis and impairment of neurodevelopmental processes has been postulated as the     underlying mechanism, but the molecular mechanisms was not completely understood. Various     hypothesis has been proposed they are- Antagonistic effect on N-methyl-D-aspartate receptors     and agonistic effect on gamma-aminobutyric acid type A receptors; mitochondrial perturbations     and activation of reactive oxygen species and dysregulation of intracellular calcium     homeostasis. They trigger neuroapoptosis and cell death through the activation of caspases.3     Caspases, a group of cysteine proteases, plays an important role in regulation and execution     of apoptosis. Caspase-3 is most important since it is activated by many cell death signals     and cleaves a variety of important cellular proteins.4 Various anesthetic agents like     isoflurane, halothane, sevoflurane, nitrous oxide and propofol causes neurotoxicity by     activation of caspase-3. Which has been proven from various animal studies western blot     analysis, immunohistochemical analysis and flow cytometric analysis.3, 5-9 Though it is     documented that exposure to general anesthetics causes neurotoxicity during active brain     growth in animals, there is no evidence of such effects in adult humans.10 and it is     difficult to separate the effects of anesthetics from surgical impact and other factors     associated with diseases.11 The patients with aneurysmal subarachnoid hemorrhage (SAH) have     variable degree of neurological insults and it is possible, based on the evidence from animal     models that administration of general anesthetics could add to the neuronal insults.   "
5539|NCT03213379|"     The goal of the study is to compare the impact of different actigraphy procedures on the     healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do     so, the study design includes a patients' randomisation in two groups that will be followed     during 6 months.   "
6748|NCT03197545|"     The study is a genetic historical cohort study in a military combat recruits - this study     does not examine a specific treatment but rather examines a statistical link between medical     history of traumatic fractures, clinical diagnosis of stress fractures and the presence of     unique SNPs in subjects DNA.   "
5544|NCT03213314|"     This observational clinical cohort study aims to evaluate the clinical utility of     LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will     enable further developments in scanning protocols and software, and clearly define the     relevance of applying this technology as part of the pre-operative assessment of the patient     being considered for liver resection or TACE.   "
5545|NCT03213301|"     Aim of this study is to provide the proof of concept of efficacy and tolerability of     lurbinectedin monotherapy in progressive malignant mesotheliomas.   "
5546|NCT03213288|"     The primary aim of this study is to directly compare the two major types of anthocyanins     found in the diet (cyanidin-type and delphinidin-type) on lipid status in adults.   "
5547|NCT03213275|"     Recent advances in neonatal intensive care have dramatically increased the survival rate of     extremely premature infants but the number of survivors with severe morbidity and lifelong     neurodevelopmental impairment remains high. Perinatal white matter injury is the predominant     form of brain injury in premature infants, often leading to adverse neurodevelopmental     outcome. Intrauterine and neonatal infection and inflammation have been identified as major     risk factors of neonatal brain injury. The fragile gut microbiome of premature infants seems     to play an important role in health and disease as distortions of the microbiome occur prior     to sepsis and necrotizing enterocolitis. Furthermore, the close link of the gut microbiome to     neurological and psychiatric diseases in animal models suggests that the microbiome may     influence brain maturation and development in preterm infants. Recent studies have underlined     the importance of regulatory T cells as well as γδ T cells in brain injury, which can be     directly influenced by the gut microbiome. It is therefore likely that an underdeveloped or     distorted gut microbiome affects host immune response and may be a risk factor for     neurodevelopmental disabilities in extremely premature infants who are already challenged by     the unphysiologic early extrauterine environment after premature birth which affects     maturation of the gut microbiome and immune system as well as neurophysiological maturation     alike.      Therefore, the overarching aim of the PreMiBraIn study is to elucidate the role of the     gut-immune-brain axis on neonatal brain injury and its impact on long-term neurodevelopmental     outcome of extremely premature infants. The study cohort will consist of a total of 60     extremely premature infants with a gestational age < 28 weeks and birth weight < 1000 grams.     The investigators seek to characterize the orchestrated dynamics of the maturation of the gut     microbiome and the subsequent impact on maturation of innate and adaptive immune mechanisms     as well as neurophysiological maturation and neurodevelopmental outcome. Furthermore, the     investigators will assess the value of the microbiome as a prognostic indicator for neonatal     brain injury as well as short- and long-term neurodevelopmental outcome of extremely     premature infants.      This goal will be achieved by state-of-the-art techniques using 16s rRNA gene sequencing of     the gut microbiome, holistic analysis of T cell biology using flow cytometry, whole     transcriptome analysis and proteomics as well as neurophysiological measurements     (amplitude-integrated EEG, near-infrared spectroscopy, visual evoked potentials) and cranial     MRI of extremely premature infants. Short- and long-term neurological outcome will be     investigated using Bayley Scales of Infant Development, Third Edition at one and two years     corrected age, and Kaufmann-Assessment Battery for Children at five years of age. The     investigators expect to find microbiome signatures that are predictive for later     neurodevelopmental disabilities which may then be used for early screening and intervention     and may suggest personalized therapeutic options. The prospects of precision medicine     targeting the gut-immune-brain axis in extremely premature infants hold the opportunity to     improve the overall outcome of these high-risk patients.   "
5548|NCT03213262|"     In this study, investigators wanted to investigate the effect of preoperative anxiety level     on anesthesia preference of patient. Before surgery, patients will fill the forms of Pain     catastrophising scale (PCS), Beck depression and Beck anxiety scale. After surgery, these     forms will be evaluated according to the choice of anesthesia.   "
5560|NCT03213106|"     Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which     currently no specific treatment is available. Some limited studies verified the effects of     cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. So     far it is not known which patients could benefit. Our hypothesis is that cerebellar TMS could     improve ataxic symptoms in some patients.   "
6253|NCT03204019|"     A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and     safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and     Thalidomide in subjects with Advanced Pancreatic Neuroendocrine Tumor   "
5549|NCT03213249|"     Breast implants, either cosmetic or reconstructive, are among the most common procedures     performed by plastic surgeons. Bacterial infections or biofilms are implicated in the     majority of breast implant complications including infection requiring explantation, capsular     contracture (CC), and/or breast-implant associated anaplastic large cell lymphoma (BIA-ALCL).     The research team, which has already extensively characterized bacterial pathogenesis in the     urinary tract and designed non-antibiotic therapeutics to reduce the incidence of     catheter-associated urinary tract infections (CAUTIs), and proposal will study     bacteria-breast implant interactions and explore further the impact of the breast microbiome.     The proposed research provides a greater understanding of which bacteria can colonize breast     implants, their source, and how effective antibiotic pocket irrigation is at eliminating     them, and begins to examine the mechanisms by which bacteria bind and colonize the implant     surface. These insights will set the groundwork for developing new therapeutic agents that     can disrupt the binding of certain bacteria to breast implants. Strategies that minimize     problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant     complications, limit antibiotic-related side effects, and reduce bacterial resistance.   "
5550|NCT03213236|"     Up to now, no studies are available where a comparison has been made between the accuracy of,     on the one hand, the gold standard PSG and, on the other hand, a home monitoring sleep     apnea-diagnostic system, consisting of a pulse oximeter, and accelerometer, a smartphone for     snoring analysis, and a mattress for ballistocardiographic (BCG) recordings.      The purpose of this study is twofold. On the one hand, a comparison between the predictive     performance of an automated home monitoring system and the gold standard PSG in sleep apnea     diagnosis will be performed. The home monitoring system consists of a pulse oximeter, an     accelerometer, a smartphone to record ambient sound, and a mattress to record the BCG signal.     This system will be provided by KU Leuven and Equilli, two partners that work together with     the Sleep Laboratory at UZ Leuven and the group STADIUS of the KU Leuven in the OSA+ project.     The system performs automated signal processing and classification in order to determine the     presence of sleep apnea events. On the other hand, this study aims to improve the phenotyping     of patients suffering from sleep apnea. This task will be first developed using the classical     PSG and later an evaluation will be performed on the less obtrusive system.   "
5551|NCT03213223|"     EXECUTIVE SUMMARY RESEARCH QUESTION TO BE ADDRESSED BY THIS PROPOSAL What are the factors     associated with retention-in-care of women enrolled in the eMTCT Option B+ program at eMTCT     (elimination of mother-to-child transmission of HIV) sites with high retention-in-care     compared to eMTCT sites with low retention in care? Hypotheses Null hypothesis H0: The     attributable rate of low retention-in-care of women in the eMTCT program at eMTCT sites     equals zero.      Alternative hypothesis HA: The attributable risk of low retention-in-care of women in the     eMTCT program at eMTCT sites is not equal to zero.      RATIONALE FOR RESEARCH There is poor retention of women along the PMTCT (prevention of mother     to child transmission of HIV) cascade. Retention in eMTCT refers to documented regular     participation of the pregnant woman, confirmed HIV positive, together with her child or     children not yet confirmed as HIV-positive, in all prescribed activities aimed at preventing     transmission of HIV from her to the child, and scheduled or unscheduled HIV-care related     visits, measured during or at the end of care. It results in uninterrupted supply of ART     (antiretroviral therapy). Retention in PMTCT ranges between 10.6% and 76.5% in other     countries. In Zimbabwe it was found to drop from 83% at second pick up of antiretroviral     drugs to 45% at fourth pick up of antiretroviral drugs. Poor retention in PMTCT leads to poor     health outcomes in the mother and the baby. These include increased viral load, reduced CD4     count, reduced adherence to ART, emergency of drug resistant HIV strains, reduced quality of     life, increased frequency of opportunistic infections, increased all-cause hospitalizations     and death of women and children. HIV infection contributes to between 6 and 20% of maternal     deaths. On the other hand, about 14% of all new infections are due to MTCT (mother to child     transmission of HIV).      Retention in care is better at some clinics and hospitals. The purpose of the study will be     to determine the factors associated with retention-in-care of women enrolled in the eMTCT     Option B+ program at eMTCT sites.      The following objectives will be addressed in the study:        1. To assess the PMTCT Option B Plus program at selected eMTCT sites.        2. To determine the prevalence of retention among women enrolled in the eMTCT Option B+          program at selected eMTCT sites.        3. To determine the incidence of attrition among women enrolled in the eMTCT Option B+          program at selected eMTCT sites.        4. To identify factors associated with variability in levels of retention-in-care of women          in the eMTCT Option B+ program at selected eMTCT sites.        5. To explore the barriers and facilitators of retention among women enrolled in the eMTCT          Option B+ program.      METHODS The study is being done through a nested, embedded, mixed methods study with priority     given to a prospective cohort methodology. The supplementary design is a simple descriptive     qualitative design carried out through focus group discussions. A mixed methods design caters     for the weaknesses in either a qualitative or a quantitative design. Hence, it is ideal in     study of complex human issues such as retention in the PMTCT Option B Plus program.      In the study, 462 pregnant women enrolled for PMTCT Option B Plus will be followed up for 12     months in an open cohort. The sample size was calculated using Stata software based on a     power of 0.8, a margin of error of 0.05, a design effect of 1.1 and a retention rate of 0.45.     Six randomly selected eMTCT sites in Mashonaland East Province were chosen for the study.     Retention rate at the sites since 2013 will be calculated. Three sites with lower retention     will be considered as the exposure sites. The other 3 sites will be the unexposed sites.     Option B Plus, a recently introduced and recommended PMTCT option, was meant to benefit     pregnant women, in addition to their children and sexual partners. Hence, the involvement of     women as participants. Four focus group discussions will also be done, with nursing mothers     to ascertain the barriers and facilitators of retention in PMTCT Option B plus. Included in     the study will be HIV positive pregnant and nursing women coming for PMTCT Option B Plus.     Women who can communicate in English or Shona and are without psychiatric conditions will     also be included. Emancipated minors, below 18 years of age will also be included. Excluded     from the study will be women enrolled in PMTCT Options A or B, women with psychiatric     conditions or those who are too ill to participate. The study was approved by The Medical     Research Council of Zimbabwe. Signed voluntary consent is sought from participants. Data is     being collected through questionnaires and audio-taped focus group discussions. Follow-up     data will also be extracted from eMTCT registers at respective eMTCT sites. Data is kept in     locked cabinets only accessible to the principal investigator and the supervisors.   "
5552|NCT03213210|"     Single arm study to evaluate the effectiveness of treatment approach using a new moldable     beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in     peri-implantitis.   "
5553|NCT03213197|"     The researchers hypothesize that patients and their families will be comfortable watching     standardized CPR informational videos and that they would recommend that others watch the     videos. Furthermore, the researchers hypothesize that patients and their families will find     the videos helpful in their own end-of-life planning.   "
5554|NCT03213184|"     The environment during the prenatal period and in early life is a major contributor to the     risk of developing childhood asthma. Birth cohort studies from single research centers have     identified several factors that affect the risk for developing childhood asthma, including     being exposed in early life to allergens, pollutants, viruses and bacteria, and psychosocial     stress. Despite such advances, further progress in understanding the root causes of asthma     have been hampered by the small size of previous studies, which makes it difficult to: 1)     identify asthma risk factors with certainty, 2) know how environmental factors across the     United States (U.S.) affect asthma, and 3) whether there are critical ages when pregnant     mothers, infants and young children are particularly susceptible to these influences.     Furthermore, different research groups tend to use different methods to study asthma, making     it difficult to either compare or pool findings. One other challenge is that there are     several types (i.e. phenotypes, endotypes) of childhood asthma, but these are poorly     understood. To help overcome these challenges, investigators leading 12 asthma birth cohorts     across the U.S. have established the Children's Respiratory Research Workgroup (CREW)     consortium. CREW proposes to identify specific types of childhood asthma, develop an     understanding of what early life environmental influences cause these different types of     asthma and when, and identify targets for future efforts aimed at preventing childhood     asthma.   "
5555|NCT03213171|"     This study evaluates the effects of using reception staff to prompt patients by providing a     pamphlet and an opportunity to register in the waiting room via a mobile tablet on deceased     organ donor registration rates.   "
5556|NCT03213158|"     The purpose of this research study is to find out how well ixazomib (the study drug) works to     desensitize highly sensitized kidney transplant recipients.   "
5557|NCT03213145|"     This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate     the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics     and safety of EDP-305 in healthy human volunteers.   "
5558|NCT03213132|"     This study will compare the efficacy of an interactive internet intervention for older adults     with insomnia called SHUTi (Sleep Healthy Using the Internet) both with and without support     for adherence to that of a static educational website to improve sleep, health, mood, and     overall quality of life.   "
5559|NCT03213119|"     The exploration of space is more effective when intrinsically rewarding elements are located     in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to     various attentional disorders. The first part of the project aims to characterize these     effects at the behavioural level. The interventional part consists then in the administration     of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of     water in the external ear activates the vestibular organs and subsequently vestibular-related     brain areas. Among the observed brain activations, the possibility to reach cingulate areas     appears particularly interesting because it foreshadows the possibility to further enhance     attentional capture by rewards.      CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in     cancellation tasks requiring the processing of targets of different nature (e.g. monetary or     neutral). The main prediction is that CVS administration would enhance spatial exploration in     terms of center of gravity of the cancellation and improved accuracy as a function of the     type of target processed (e.g. its value).   "
6254|NCT03204006|"     Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single     Dose of Dexmedetomidine in Hypertensive Patients.   "
5563|NCT03213067|"     Gastrointestinal (GI) dysmotility in patients with mitochondrial disease are increasingly     recognized and often include dysphagia, abdominal pain, abdominal distention, bacterial     overgrowth, constipation, and in severe cases surgery. Although the proposed pathological     mechanisms underlying the development of GI dysmotility remain diverse, potential mechanisms     include mitochondrial dysfunction of smooth muscle within the GI tract and visceral myopathy.     Moreover, bacteria within the GI tract, termed 'gut microbiota' has also been identified as a     key contributor towards GI dysmotility.      Aim: The aim of this study is to assess the role that the gut microbiota has on clinical     disease expression in patients with mitochondrial disease.      Objectives: This is a feasibility study to assess:        1. How does clinical disease severity impact upon the gut microbiota in mitochondrial          patients compared to healthy controls.        2. How diagnostic and therapeutic approaches for mitochondrial disease be improved.      Methods: This is a pilot study and is part of the Newcastle Mitochondrial Research Biobank.     Stool samples will be collected from patients with a Mitochondrial Encephalomyopathy Lactic     Acidosis and Stroke-like episodes (MELAS) phenotype carrier of the m.3243 A>G mutation (N=20)     from the UK MRC Centre for Mitochondrial Disease Patient Cohort (RES/0211/7552, the largest     cohort of mitochondrial patients in the world) and the mitochondrial clinic and age and     gender matched healthy controls (N=20). DNA will be extracted from stool samples and the 16S     rRNA gene (V4 region) will be sequenced. This data will be analysed using bioinformatics     pipelines and computational biology.      Long Term Goal: To generate novel information relating to how the gut microbiota impacts upon     clinical disease expression. This information could then be used to build a predictive model     designed to optimise diagnosis and therapeutic treatments. This method also holds potential     for use as a model for ageing and diseases associated with mitochondria not working properly,     such as diabetes, cancer and Parkinson's disease. This research has the potential to reduce     costs to the NHS and improve patient care and their quality of life.   "
5564|NCT03213054|"     This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in     combination with radiation therapy in patient with esophageal cancer who are not applicable     to standard therapy.   "
5565|NCT03213041|"     The purpose of the study is to evaluate the impact on progression-free survival (PFS) with     the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells)     positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and     taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to     chemotherapy and maybe associated with a weak immune system. This study is investigating the     use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of     controlling and killing cancer cells of an important component of your immune system called     T-cells. Pembrolizumab has been found effective in other types of cancer and has already been     approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In     this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell     killing. There is no control or placebo treatment in this study.   "
5566|NCT03213028|"     The goal of this pilot study is to assess both implementation outcomes (acceptability,     feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing     to avoid pregnancy) using a Hybrid Type 2 study design of a family planning program being     piloted by the Cervical Cancer Prevention Program in Gabarone, Botswana.   "
5567|NCT03213015|"     The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of     motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand)     and to verify if there is correlation between the limitation of the ADROM and the PFP.   "
5568|NCT03213002|"     The purpose of this study is to evaluate the safety and efficacy of administering the     medication capecitabine along with temozolomide when you start your monthly regimen of oral     temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).      Capecitabine is an oral chemotherapy that is given to patients with other types of cancer.     The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after     radiation, when taken along with temozolomide. It will also try to determine if the     medication capecitabine helps patients respond to treatment for a longer period of time     compared to just temozolomide alone, which is the standard of care.   "
5569|NCT03212989|"     This is a phase I, single-site, study to evaluate the effects of VOR and HIV-1 Antigen     Expanded Specific T Cell Therapy (HXTC) on persistent HIV-1 Infection in HIV-infected     individuals suppressed on cART. Twelve participants with durable viral suppression will be     enrolled and will complete the study. All participants will receive the same treatment and if     eligible, will be dosed with HXTC and VOR. Participants will continue their baseline cART     regimen throughout the study.   "
27552|NCT02925104|"     Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in     patients with cMET dysregulated advanced solid tumors.   "
5572|NCT03212950|"     A randomized, double-blinded (for insulin type), single centre, crossover design young adult     study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring     time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed     Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency     number EMEA/H/C/004046) or normal acting insulin Aspart.      Study duration will be about 3 weeks per subject, 5 month overall.      The objectives of this clinical investigation is:      1. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter     with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity     and unannounced meals, in a controlled in-hospital environment.      Primary endpoint is significant between-group difference (intervention Fast-CL versus control     Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl)     during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till     18:00 next day based on sensor glucose readings.   "
5573|NCT03212937|"     This is a single center, open-label, phase I trial with a standard 3+3 dose escalation schema     to identify the maximum tolerated dose (MTD) of selinexor when combined with ICE. Once MTD is     determined, there will be an expansion phase and tumor biopsies and peripheral blood will be     taken pre and post selinexor to examine the study's biologic objectives.   "
5574|NCT03212924|"     Listening with a cochlear implant remains difficult and most listeners will report high     levels of listening effort.The present study is a pilot aiming to evaluate listening effort     for cochlear implant users. The listening effort is measured with pupillometry, by monitoring     the variations of pupil size in response to different stimuli. The size of the pupil is known     to increase with the listening effort. The listening effort is evaluated in two different     situation: speech perception in quiet and speech perception in noise. The pupillometry     measures will be compared for the two listening conditions. Moreover, the study will evaluate     the relationship between objective (pupil dilatation) and subjective measures (auto     evaluation) of listening effort, and between speech comprehension, cognitive abilities and     listening effort.   "
5575|NCT03212911|"     The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active     hepatitis could cause by several scenarios, including false positive, remote infection     without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine     booster could be a great prevention strategy for those who do not have HBV viremia. There is     no standard consensus for management of this issue especially among HIV infected population.     In addition, prior studies revealed that HIV-infected individuals had lower immunologic     response to HBV vaccine than general population. This study intends to compare the immune     response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in     HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after     the participants receive vaccination.   "
5576|NCT03212898|"     The primary study goal is to explore the influence of pharmacist interventions on the     effectiveness of warfarin treatment in a specific subpopulation.   "
5577|NCT03212885|"     Patients with Parkinson's Disease who undergo Deep Brain Stimulation surgery receive symptom     relief due to electrical stimulation of the brain. The target for the stimulation, in many     cases, is the subthalamic nucleus (STN). The brain area just above the STN is called the     rostral Zona Incerta (rZI). The rZI may be a potential target for deep brain stimulation, in     combination with the STN.   "
5578|NCT03212872|"     Assessment of blood ammonia level as a non-invasive predictor for presence of EV and risk of     bleeding   "
5579|NCT03212859|"     In a previous trial, researchers demonstrated that the Coach2Move approach is superior to     regular physiotherapy in terms of increasing physical activity, reducing frailty, improving     quality of life and reducing healthcare costs. In short, in less physiotherapeutic sessions,     better outcomes were realized.      Despite these promising findings, the research group still has questions regarding the     generalisability of these findings. The reservations towards the generalisability of the     approach are caused by the following:        1. A modest (n=130), yet somewhat selective study sample was included: nearly half of the          eligible individuals declined randomisation and thereby participation. An understanding          is needed how this group of eligible non volunteers respond to Coach2Move. Therefore, a          study design that avoids randomisation at the patient level will be used.        2. The Coach2Move approach significantly increased the level of moderate physical activity          among the treatment group and reduced levels of frailty significantly after 6 months,          but the clinical importance of these findings is still unclear. Thus, a replication of          the effects in the light of physical functioning is needed in a larger more variable          study population and with a longer follow-up.      In addition, the results from the earlier carried out RCT concerning the cost-effectiveness     of Coach2Move have to be replicated on a larger scale.      For the reasons mentioned above, it is important to further implement Coach2Move and study     its effect, costs, and feasibility in current practice. A stepped wedge cluster randomised     trial design is chosen because in the opinion of the researchers, the implementation strategy     will do more good than harm (making a parallel design, in which certain practices do not     receive the intervention or to withdraw the intervention as would occur in a cross-over     design, is unethical) and it furthermore minimizes contamination.      The objective of this study is to assess the cost-effectiveness of the implementation of a     patient and context focused tailored coaching intervention (Coach2Move) in the daily     physiotherapy practice for older adults with mobility problems compared to usual     physiotherapy. The hypothesis is that Coach2Move leads to better physical outcomes and lower     costs than usual care.   "
5580|NCT03212846|"     The aim of this study is to evaluate if a intervention with hippotherapy will improve     spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will     be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in     addition to traditional treatment.   "
5591|NCT03212703|"     The purpose of this study is to investigate the role of a mindfulness-based skills training     program for parents of children with obsessive compulsive disorder (OCD). The investigators     will explore if parents involved in this group experience any change in their levels of     stress, feelings of being an effective parent and family relationships compared to a waiting     list control period. The investigators will look at how the family manages OCD in their     lives. In particular, if mindfulness skills training will help increase the parents ability     to tolerate distress in their child secondary to OCD and as such reduce the family     accommodation of OCD. As family accommodation is an important negative prognostic predictor     for children with OCD, changes in OCD symptom severity and functional impact in these child     will also be measured.   "
5581|NCT03212833|"     Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000     deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic     Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers,     was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009).     It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al     2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), (     Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals     (DAAs) have shown improved efficacy and tolerability compared with interferon     (IFN)-containing regimens, and they have become the standard of care for treatment of HCV     genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given     concentration of insulin produces a less-than-expected biological effect. The prevalence of     type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than     among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin     resistance and insulin resistance induces interferon resistance, steatosis and fibrosis     progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained     response rate, and increase the risk for the development of steatosis and fibrosis     progression, However, the impact of insulin resistance in other genotypes seems not achieve     enough importance to impair sustained response, probably due to the high sensitivity to     peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could     improve sustained response rate in patients with chronic HCV-1 infection when treated with     peginterferon plus ribavirin(Romero-Gómez,2006).      Objectives: we aim to determine the prevalence of insulin resistance among the patients with     chronic hepatitis C virus( HCV) infection and to explore the association between insulin     resistance and therapeutic response by comparing the insulin resistance among responders and     non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods:     The study is intended to include patients of chronic hepatitis C virus infection receiving     oral treatment for one year period. All patients will have clinical evaluation,     ultrasonographic examination, and laboratory investigations which include complete blood     count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and     determination of insulin resistance index.The patients will be selected according the     selection criteria determined by the National Committee for Control of Viral Hepatitis     (NCCVH).   "
5582|NCT03212820|"     20 patients were selected requiring implant placement and divided randomly into two groups     (10 in each group)        -  for the study group, starter drill is used to locate the point of insertion as planned          then pilot drill is also used to the full desired working length after that all other          sequential drills are used at a low speed (50-70 rpm) without irrigation .        -  In the study group: implant will be inserted in the low speed osteotomy site.        -  In the control group: implants will be inserted in the conventional prepared osteotomy          site.        -  For both groups there is no surgical guide used.        -  The flap will then be copiously irrigated with saline in preparation for closure.        -  The flap will then be closed using interrupted 4/0 resorbable sutures.   "
5614|NCT03212404|"     CK-301 is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed     Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and     B7.1 receptors. The primary objective of this study is to assess the safety, tolerability and     preliminary efficacy of CK-301 when administered intravenously as a single agent to subjects     with selected recurrent or metastatic cancers.   "
5583|NCT03212807|"     PHASE II STUDY OF DURVALUMAB IN COMBINATION WITH LENALIDOMIDE IN RELAPSED/REFRACTORY EBV     ASSOCIATED SUBTYPES OF DLBCL, PRIMARY CNS LYMPHOMA AND PRIMARY TESTICULAR DLBCL      Patients with relapsed refractory subtypes of DLBCL who fulfill the inclusion / exclusion     criteria will be recruited to this trial and treated in this open label, phase 2 trial with     the PDL1 inhibitor Durvalumab and Lenalidomide. The combination treatment will be given from     the time of recruitment for 6 months when Lenalidomide will be stopped but Durvalumab will     continue for a total of 2 years. Response will be assessed by PET / CT scans as per standard     lugano criteria.   "
5584|NCT03212794|"     The purpose of this 24-week study is to evaluate the impact of recovery coach intervention on     rates of treatment retention, illicit opioid use, and readmission among hospitalized patients     newly initiated on buprenorphine compared to the control intervention.   "
5585|NCT03212781|"     Iron deficiency is the most prevalent nutritional deficiency and the most common cause of     anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells     that are abnormally small (microcytic) and contain a decreased amount of hemoglobin     (hypochromic).   "
5586|NCT03212768|"     Ankle fractures are among the most common osseous injuries to the lower extremity, and remain     a significant source of morbidity for both the young and the elderly. Recent cross-national     studies have shown a significant increase in the incidence and severity of ankle fractures     among the elderly population.   "
5587|NCT03212755|"     Diabetes mellitus is a chronic disease that affects 366 million people worldwide ( 6.4 % of     the adult population ) and is expected to rise to 522 million by 2030 . Diabetic nephropathy     occurs in approximately one - third of all people with diabetes and is the leading cause of     renal failure in developed and developing countries Diabetic nephropathy is a severe     complication occurring in diabetic patients and it is associated with an increased risk of     all- cause mortality , cardiovascular disease and progression to end stage renal disease ,     requiring costly renal replacement therapy in the form of dialysis or transplantation   "
5588|NCT03212742|"     The Stupp protocol is the standard treatment of glioblastoma multiform (GBM) which prognosis     remains poor.      The non-dividing nature of normal brain cells provides an opportunity to enhance the     therapeutic ratio by combining radiation with inhibitors of replication-specific DNA repair     pathways such poly(ADP-ribose) polymerase (PARP) inhibitors, thus inducing more cytotoxic     effects of DNA-damage related to treatment modalities, including alkylating reagents like     temozolomide (TMZ).      Olaparib, a potent PARP inhibitor, overcomes apoptotic resistance and sensitizes GBM cells     for death receptor-mediated apoptosis induced by TRAIL (Tumor necrosis factor-Related     Apoptosis Inducing Ligand). Moreover, inhibition of PARP activity increases cellular     sensitivity to ionizing radiation: it was even suggested to be more pronounced in tumors than     in normal tissue.      Lastly, progress in technical imaging and intensity-modulated-radiotherapy (IMRT) techniques     provide new possibilities for sparing healthy tissues.   "
5589|NCT03212729|"     Microorganisms play a critical role in the etiology and pathogenesis of apical periodontitis.     Enterococcus faecalis and Candida sp. are frequently associated with persistent infections.     The aim of this study was evaluated the antimicrobial photodynamic therapy (aPDT) as an     adjunct of the endodontic treatment. Ten uniradicular teeth [control group (CG)=4 and test     group (TG)=6] with primary endodontic infections were analyzed. Microbiological samples were     collected before and after the chemical-mechanical instrumentation (CMI), after the aPDT (for     the TG) and after the temporary restorations removal (second session).   "
5590|NCT03212716|"     The aim of this study is to evaluate the possibility to repropose marketed drugs as antiviral     ones, based on their ability to reverse the transcriptomic signature of the infected cells.     This strategy has to be considered is the context of emerging viral diseases and of increase     of resistance to antivirals. Concerning infection by Influenza viruses, two main drugs were     identified and evaluated on in vitro and in vivo models: etilefrine and diltiazem. Therefore,     it will be assess the efficacy of these two drugs, compared to placebo, to treat severe flu.   "
7942|NCT03181906|"     This study evaluates the the effectiveness of pre-consultation Medication Reconciliation     Service in reducing unintentional medication discrepancies among patients who discharged from     hospital to primary care.   "
5592|NCT03212690|"     The purpose of this study is to assess whether circulating Angiotensin (Ang) II and Ang (1-7)     levels are associated with right ventricular (RV) dysfunction in mechanically ventilated     subjects. It is also designed to further characterize the subject population for severity of     RV dysfunction. This study will investigate the association of renin-angiotensin system (RAS)     peptides and markers of RV function, as measured by echocardiography, in subjects requiring     acute mechanical ventilation. Maximum 150 subjects will be enrolled for the study and they     will be evaluated over three days period using standard of care investigations, including     trans-thoracic echocardiography (TTE) and/or trans-esophageal echocardiography (TOE)     echocardiography. The maximum total duration of this study for subjects is 28 days.   "
5593|NCT03212677|"     Iron deficiency-related anemia is the most common nutritional deficiency disorder in the     world, mainly affecting children, women and older adults in underdeveloped countries. To     combat iron deficiency, inorganic forms of iron (such as ferrous sulfate) are often used as     an iron supplement. One big problem is that high levels of this kind of iron supplement     produce negative health effects. This includes diarrhea, changes in the bacteria in the gut,     as well as increased severity to malaria in young children in countries with high rates of     that parasite.      Most forms of iron are not well absorbed and, therefore, pass through the intestine to be     eliminated in the stool. This unabsorbed iron can be used by gut bacteria, disturbing the     balance of healthful and potentially harmful bacteria in the colon, which can increase     inflammation in the body.      In this study, the investigators are seeking to determine whether two new forms of iron cause     fewer changes in the gut bacteria thus lowering inflammation while providing similar amounts     of iron to the body. The findings from this research study are important because they will     inform the development of safer treatments for iron deficiency.   "
5594|NCT03212664|"     The primary aim was to assess whether a one-time physical therapy program for hyperkyphosis     is effective. Participants received physical therapy exercises and were followed for 6 months     for pain intensity, quality-of-life, and perceived spinal appearance.   "
5595|NCT03212651|"     monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the     interaction between PD-1 and its ligands, PD-L1 and PD-L2; Recent phase I trial provided     evidence of activity of pembrolizumab in advanced platinum-resistant metastatic urothelial     carcinoma; Recent phase 3 trial showed an overall survival benefit in patients treated with     pembrolizumab in a trial comparing pembrolizumab to chemotherapy in patients who failed     first-line platinum-based chemotherapy Neoadjuvant chemotherapy followed by radical     cystectomy is the standard of care for cisplatinum-eligible non-metastatic MIBC patients;     Many patients with MIBC are unfit for cisplatin-based combination treatment; Given its safety     profile, pembrolizumab may be used in unfit patients; Neo-adjuvant setting is a unique     opportunity to assess mechanisms of action of pembrolizumab in human   "
5596|NCT03212638|"     The purposes of this study are to determine:        -  If there are any differences in the amount of baricitinib in the blood/body when taken          in two different forms.        -  How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.        -  The safety and tolerability of baricitinib.      The study has two parts. Individuals will participate in only one part.      Participants will be admitted to the clinical research unit (CRU) and will be discharged from     the CRU following the completion of 3 overnight stays.      Each part of this study will last from 8-10 days, not including screening. Follow-up will     occur 7 to 14 days after the last dose of baricitinib.   "
5597|NCT03212625|"     Many investigators have studied for prevention and care of Hand-Foot Skin Reaction(HFSR), and     urea cream is typical representative. Recent study was performed prevention effect of urea     cream for Hand-Foot Skin Reaction(HFSR) on 871 Chinese. But the study did not designed as     placebo-control group and it had big defect in double-blinded.      Therefore, it needs complementary study as double-blinded placebo-controlled trial and effect     of urea cream on Korean patient group.   "
5598|NCT03212612|"     The exact cause of endometriosis is unknown ,so our study is to investigate the relationship     between Galectin-3 and endometriosis by comparing between its level in healthy and     endometriosis women. Also, we will measure the level of oxidative stress markers in     endometrium of both healthy and endometriosis women and investigate the correlaton between     them and galectin-in endometriosis women.   "
5599|NCT03212599|"     A causal therapeutic approach for treatment of Alzheimer's disease has not been established     so far. The protein ADAM10 represents a promising target for an A-beta peptide preventing     strategy. Treatment of human neuronal cells with Disulfiram, a drug which is used in clinical     routine for recrudescence prevention of alcohol dependency, revealed an increased expression     of ADAM10. This finding indicates a neuroprotective potential of Disulfiram. The     investigators' research purpose aims at the verification of the results obtained in cell     culture experiments in the human organism. Therefore, include alcohol addicted patients were     included, which take the drug Disulfiram for recrudescence prevention, in our study. Patients     are recruited from the patient-collective of the University Medical Center Mainz and the     Central Institute for Mental Health Mannheim. Blood samples (max. 5 ml) are taken from the     participants before the intake of Disulfiram and about two weeks after treatment. Demographic     data are collected (such as age or onset of addiction). Gene expression is analyzed via     reverse transcription polymerase chain reaction(RT-PCR) from blood cell-derived messenger     ribonucleic acid (mRNA).   "
5600|NCT03212586|"     This study is a first in human study that will investigate the safety, tolerability and     pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled,     randomized, single center design. In addition the influence of food on the pharmacokinetics     of BAY1902607 and the bioavailability between different pharmaceutical formulations will be     investigated.   "
5601|NCT03212573|"     A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be     randomized in 2 groups: those following an ERAS program and those ones following a standard     protocol.      Postoperative pain 24 hours after surgery and hospital stay will be assessed.   "
5622|NCT03212300|"     This is a randomized study to examine whether aerobic exercise training (AET) before total     shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and     shorten time to recovery in elderly patients. POD is a form of sudden change in mental     function that could be experienced after undergoing surgery.   "
7943|NCT03181893|"     A Study looking at Investigational drug and Placebo administered to adult Patients with     moderate to severe Dermatomyositis   "
5602|NCT03212560|"     Hematologic malignancies are neoplasms that affect the blood, bone marrow, and lymph nodes.     Hematological malignancies are the most common forms of leukemia, lymphoma, and myeloma, with     numerous subtypes. The general symptoms of leukemia are fatigue, increased susceptibility to     infection, bleeding, and the formation of bruises easily. Typical lymphoma symptoms are night     sweats and involuntary weight loss, recurrent fever, fatigue, and itching. Myeloma patients     often have bone pain, fatigue, anemia, hypercalcemia or infection symptoms.      Adverse effects of hematologic malignancies and treatments cause abnormality in physical     function and quality of life. Treatments such as chemotherapy, radiotherapy and hematopoietic     stem cell transplantation, which may have side effects on the body systems are used in early     or late period. The most common side effect due to chemotherapy is fatigue. Vomiting, weight     loss, anemia, depression, decreased aerobic capacity, loss of muscle strength, decreased     physical functioning and deterioration in the quality of life are indirect side effects seen     in patients.      In the literature, side effects of hematological malignancies have been investigated after     treatment in patients. However, no study investigated exercise capacity, quality of life,     physical activity level and pulmonary functions on newly diagnosed hematologic malignant     patients. Therefore, the investigators aimed to compare aforementioned outcomes in newly     diagnosed hematologic malignant patients and healthy controls.   "
5615|NCT03212391|"     Monocentric unblinded two parallel-group randomized controlled trial to evaluate the effect     of diet with or without Nordic Walking on weight loss, physical performance and     cardiovascular risk factors in overweight and obese population   "
5616|NCT03212378|"     In routine clinical practice, high-risk patients with high-risk anatomies are more often     referred for interventional treatment by percutaneous coronary interventions (PCI). Current     guidelines only suggest that elective insertion of an appropriate hemodynamic support device     as an adjunct to PCI may be reasonable in selected high-risk patients.      The objective of this retrospective study is to investigate the safety and efficacy of a     standardized program for complex high-risk interventional procedures (CHIP).   "
5603|NCT03212547|"     The objective of this project is to determine the effect of the verbal intervention on the     decrease in sustained social withdrawal in late and moderately late preterm infants. The     intervention will be performed by pediatricians trained in the Alarm Distress Baby Scale     (ADBB). This scale has been applied to term and preterm newborns in multiple international     studies, but it has not yet been applied in Chile, nor with moderately late and late preterm     infants.      Infants are social beings who are born with innate reciprocal communication skills that can     be observed during the two first months after delivery in babies with normal development.     These skills include abilities to make and maintain eye contact, to vocalize and to use     facial expressions, body and head movements to start interactions. Micro-analytical studies     have demonstrated the frequent appearance of short episodes of social withdrawal affecting     the infant during mother-baby interactions, whose function is to regulate the interaction     flow. This behavior can be perceived when the infant needs to calm down or when is tired, and     as a reaction to transitory interaction disturbances. In contrast with these short episodes     of social withdrawal, the occurrence of sustained social withdrawal in infants is     significantly less and is frequently associated with pathological conditions, such as autism     spectrum disorder, child depression, and severe or chronic pain. Additionally, sustained     social withdrawal is a symptom of anxiety and post-traumatic stress disorders. Different     studies have revealed a prevalence of 10-14% sustained social withdrawal in term infant     populations and of 13-22% in pre-term infant populations. In addition, the increase in     sustained social withdrawal has been related to deviations of the interaction skills,     attachment, as well as to relational and behavioral disorders. The increase and     chronification of sustained social withdrawal, used as a defensive conduct, imply a risk to     the adequate development of an infant's potential and raise the probability of alterations in     the development of his psychopathology.   "
5604|NCT03212534|"     Through the mapping of retrospective patient data into a discrete multidimensional space, a     novel algorithm for homeostatic analysis, was built to make outcome predictions. In this     prospective study, the ability of the algorithm to predict patient mortality and influence     clinical outcomes, will be investigated.   "
5605|NCT03212521|"     A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in     treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and     with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.   "
5606|NCT03212508|"     Continuous distending airway pressure (CPAP) has gained popularity as a means to provide     non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI).     However, maintaining CPAP in preterm infants has been challenging, often related to issues     with nasal interface such as nasal septal injury, problems with keeping the prongs in the     nose and leak around the prongs with are important factors in proving effective CPAP. RAM     cannula was recently approved for providing supplemental oxygen and soon adapted by many     centers to provide CPAP in preterm infants. Concerns have been raised that RAM cannula     interface results in sub-optimal pressure delivery compared to standard nasal prongs.   "
5607|NCT03212495|"     Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis,     meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of     postoperative pain, which is caused by an irritation of free nerve endings of the synovial     tissue, anterior fat pad, and joint capsule due to surgical excision and resection   "
5608|NCT03212482|"     Mechanical ventilation is an important support strategy for critically ill patients. It could     improve gas exchange, reduce the work of breathing, and improve patient comfort. However,     patient-ventilator asynchrony, which defined as a mismatch between the patient and ventilator     may obfuscate these goals. Studies have shown that a high incidence of asynchrony (asynchrony     index > 10%) is associated with prolonged mechanical ventilation and ICU length of stay and     high mortality. So far, there have been only a few studies on the epidemiology of asynchrony     in brain-injured patients. Investigators conduct a prospective observational study among     brain-injured patients to determine the prevalence, risk factors and outcomes of     patient-ventilator asynchrony. Esophageal pressure monitoring, a surrogate for pleural     pressure, combined with airway pressure and flow waveforms is used to detect     patient-ventilator asynchrony.   "
5609|NCT03212469|"     The study is an open label, paucicentric, Phase I/II trial aiming to evaluate the safety, the     clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating     Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in     patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.   "
5623|NCT03212287|"     To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg     or 90 mg (hereinafter referred to as BRILINTA) in clinical practice in the post-marketing     phase.        1. Profile and incidence of ADRs The CEI will be conducted to collect data of the events,          especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate          onset, outcome, treatment for the event, and risk factors for these events, etc.        2. Profile and incidence of ADRs not expected from Precautions for Use of the ticagrelor          JPI        3. Efficacy: Profile and incidence of cardiovascular events (cardiovascular death,          non-fatal myocardial infarction and non-fatal ischemic stroke)        4. Factors which may affect safety or efficacy of ticagrelor   "
5624|NCT03212274|"     This phase II trial studies how well olaparib works in treating patients with glioma,     cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that have spread to other     places in the body and usually cannot be cured or controlled with treatment. Olaparib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
5610|NCT03212456|"     The use of opioids facilitates angiogenesis and has a proven action in the immune system,     mainly in the reduction of natural killer cell activity, favoring the migration of neoplastic     cells and inhibiting humoral and cellular immunity. These factors may contribute to     recurrence and tumor metastasis.      Therefore, could opioid-free anesthesia help reduce tumor recurrence? This is a prospective     randomized controlled clinical trial in which patients undergoing radical prostatectomy will     be evaluated by conventional means, which have moderate and high D'Amico criteria for tumor     recurrence.      In the operating room, patients will be monitored, receive peripheral venoclysis and then     randomized into two groups: in group I, the anesthetic induction will be done with pre     oxygenation with 100% O2, propofol, cisatracurium, lidocaine and fentanyl; In group II the     induction will be done with the same doses of propofol, cisatracurium, lidocaine and placebo.      In both groups maintenance of general anesthesia will be with propofol 1% target infusion     controlled with model of Marsh target-controlled infusion plasma between 2.0 and 3.0 mcg /     ml, ketamine, lidocaine and dexmedetomidine.      Both groups will receive blockade of the transverse plane of the ultrasound guided     ultrasound, group I with placebo (saline 0.9% 20 ml on each side) and group II with     ropivacaine 0.375% 20 ml on each side. And the postoperative analgesia will be based on     anti-inflammatory and opioid analgesics (pca of morphine) according to the analgesic pain     scale of the patients.      In the postoperative period, patients will be followed up for 2 years with serial doses of     prostate specific antigen (PSA) to diagnose tumor recurrence (2 PSA measures> 0.2 ng / ml)     and will be evaluated in relation to analgesia, need for analgesia of Rescue with morphine,     satisfaction with the anesthetic technique, adverse effects (nausea and vomiting).      The primary objective is to evaluate tumor biochemical recurrence after radical prostatectomy     in patients undergoing opioid anesthesia compared to patients anesthetized without opioids.     The secondary objectives are to evaluate the quality of analgesia with the two techniques,     patient satisfaction with perioperative period, quality of anesthetic recovery and adverse     effects (nausea and vomiting, pruritus and drowsiness).      Thus, to answer the hypothesis raised, 146 patients will be needed (73 in each group).   "
5617|NCT03212365|"     Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their     operative procedures. Thus, plastic & reconstructive surgery patients are among those at     highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Our     preliminary data has shown that a fixed, or one size fits all dose of enoxaparin, an     anticoagulant, can allow a high proportion of patients to have appropriately thinned blood,     measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to     have significantly decreased venous thromboembolism risk (VTE), which is desirable. However,     30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who     are over-anticoagulated are significantly more likely to have ADEs including bleeding     requiring return to the operating room, need for blood transfusion, or death. The optimal way     to dose enoxaparin to minimize ADEs remains unknown. This study seeks to optimize both the     safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding     events, and VTE events among plastic & reconstructive surgery patients randomized to receive     two different enoxaparin dose regimens.   "
5619|NCT03212339|"     This study will examine the efficacy of a dyadic therapy intervention for mothers who have     histories of adverse events (e.g., history of family violence, partner violence, family     conflict, and/or childhood trauma, including abuse/neglect) and their very young children     (ages 0-5 years), with the goal of demonstrating how an evidence supported, community-based     and/or hospital-based therapeutic intervention may help reduce exposure to trauma and     incidents of child maltreatment, improve parental stress and mental health, and secure     parent-child attachment.      The three main objectives associated with Project BELONG are: 1) to determine the     effectiveness of a dyadic care model in improving parent/child interaction, parenting     confidence and competence, reducing parenting stress and social isolation, and improving     access to concrete supports; 2) to address maltreatment risk in children by enhancing     social-emotional functioning and developmental progress; and 3) to train new and future     mental health professionals in dyadic mental health services and disseminate the model and     findings through health professional schools and publications.   "
5620|NCT03212326|"     There is a high correlation between scar areas identified by contrast-enhanced ICE and scar     areas identified by conventional electroanatomic mapping. Therefore, the investigators will     assess the utility of contrast-enhanced ICE to identify and localize myocardial scar     real-time during VT ablation procedures.   "
5621|NCT03212313|"     This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in     subjects with different degrees of hepatic impairment to the PK of a single-dose of     tozadenant in healthy subjects.   "
5625|NCT03212261|"     The Relaxation Response Resiliency Program (3RP) was developed by researchers at the MGH     Benson-Henry Institute for Mind Body Medicine; This program has recently been adapted to     target the needs of individuals who have completed treatment for lymphoma (3RP-Lymphoma).   "
5626|NCT03212248|"     This preliminary study investigates in patients with possible clinical diagnosis of     pneumonia, clues and biomarker assessed at Emergency Department (ED) triage, potentially     predicting detection of lung consolidation by Thoracic-ultrasound (TUS) and/or by     Chest-X-Rays. Cough and high admission CRP levels will be defined according to the cutoff     defined by ROC analysis, will be challenged if independently associated with TUS lung     consolidation detection High level of the chosen biomarker, and any of the considered     symptoms, in otherwise not extremely critical patients (CURB65≤3), should prompt to immediate     confirm by TUS, during the physical examination. This may limit the need of further     radiological investigations allowing targeted workup.   "
5627|NCT03212235|"     Notwithstanding major improvements in treatment modalities, the prognosis of patients with     glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard     6-week regimen could be an attractive approach as an effort to prevent tumor cell     repopulation and reduction the total treatment period promoting patient comfort and     convenience.   "
5628|NCT03212222|"     The purpose of this study is to evaluate how visual acuity assessed with Peek Acuity (a cell     phone application to check visual acuity) among preschool and school-aged children 3 to less     than18 years of age (1) compares to the standard visual acuity exam in the ophthalmology     clinic and (2) performs as a screening test for ocular abnormalities that warrant referral     for an eye exam.   "
5629|NCT03212209|"     This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and     Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with     moderate to severe OSA.   "
5630|NCT03212196|"     This trial will investigate what surgical technique between pancreaticogastrostomy and     pancreaticojejunostomy with transanastomotic externalized drains is associated with the     lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk     pancreatic remnants.   "
5631|NCT03212183|"     The purpose of this pilot randomized controlled trial is to evaluate a web-based virtual     nursing intervention (ÉPI-TAVIE) in terms of 1) acceptability and feasibility, and; 2)     preliminary efficacy.   "
5632|NCT03212170|"     The goal of this research is to test the accuracy of PET/MRI imaging with     18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression     in patients with invasive breast cancer. We hypothesize that FFNP SUVmax from PET/MRI will     correlate well against the semi-quantitative PR immunohistochemistry score.   "
5639|NCT03212079|"     PATH is a research study for cancer survivors to help participants to become more active.     Studies suggested an association between inactivity and cancer. The investigators created new     novel ways and technologies that may help participants to become more active. The three     methods the investigators are studying are: 1) participant become active on her/his own;     educational material will be provided; 2) working with a programmed health coach over the     phone via text messages; and 3) using digital voice assist to help participant become more     active. The digital voice assist will be delivered via Amazon Alexa on Echo speaker (it is     the famous intelligent voice that you see in superball commercial by Alec Baldwin). This     study is funded by the State of Maryland.   "
5640|NCT03212066|"     The purpose of this study is to conduct a randomized controlled trial to evaluate the     efficacy of the Master Mind program, a mindfulness education substance abuse prevention     program. The program has the goal of enhancing coping strategies and decision-making skills     and preventing substance abuse in late elementary school students.   "
5633|NCT03212157|"     The roles of imaging in cancer may be divided into that of diagnosis and tumour detection,     staging and assessment of response to treatment. Standard radiological techniques include     ultrasound, Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Positron Emission     Tomography (PET). A combination of imaging techniques is often necessary to differentiate     between cancerous and normal tissue. Traditional imaging techniques identify cancers by their     gross appearance and structural/ cellular characteristics, whilst PET do so by tracking     glucose metabolism. PET owes its specificity to the high rate of glucose metabolism seen in     most cancers. However it is not used routinely due to a lack of availability and high costs.     In addition, PET is often used in combination with CT, which imparts a significant diagnostic     radiation dose. This can increase an individual's risk of cancer, especially with childhood     or early adult exposure. In contrast, MRI is more readily available and does not involve     radiation. However its ability to detect cancer by tracking glucose metabolism has not been     widely explored. Our group has recently developed a novel MRI technique called Gluco-CEST     that can image glucose delivery, uptake and metabolism in cancer, therefore potentially     allowing a radiation-free, one-stop imaging service that can be adapted to current generation     of MRI scanners. This study aims to optimise the GlucoCEST technique, after which it will be     rigorously tested and compared to standard imaging parameters and clinical or pathological     reference standards to evaluate its diagnostic and predictive power across a number of cancer     populations.   "
5634|NCT03212144|"     This study will enroll and randomly assign 30 sedentary, healthy overweight men and women to     two groups. Participants will either start by consuming peanuts for 4 weeks, and then go on     to exercise at high intensity intervals (HIIT) for 4 weeks, or the reverse order. The study     will test and compare the effect of peanuts and exercise on inflammation and heart rate     variability as indicators of heart health. Specifically, the study will measure inflammation     in the blood because there is evidence that higher inflammation is found in heart disease     patients. There is also evidence that inflammation is related to death as a result of heart     disease in healthy individuals. Finally, there are ongoing trials targeting these markers to     improve heart health. The study hypothesizes that peanuts and exercise will reduce     inflammation. It is also expected to find less inflammation because exercise and peanut     consumption activate a part of the nervous system that has been shown to cause a similar     effect.      Additionally, previous studies show that inflammation involves the mitochondria in the cell,     the part of the cell that produces energy. For this reason, it is expected that exercise and     peanuts will cause changes in the mitochondria. The study will test and compare mitochondrial     activity in response to peanut consumption and exercise.   "
5635|NCT03212131|"     This trial is conducted in Europe. The aim of this trial is to investigate the effect of     abnormal liver (hepatic) function on the amount of trial drug getting into the body and     removal of the drug from the body (this is called pharmacokinetics).      In this trial the participants will receive three subcutaneous (under the skin) injections of     the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug     similar to human growth hormone) intended for once-weekly subcutaneous administration.   "
5654|NCT03211884|"     The primary aim of the proposed study is to assess the efficacy of PST for positively     impacting distressed military family caregiver's burden, and depression levels, ultimately     enhancing their mental health QOL (primary outcomes). Data will also be collected to     characterize physical and social stressors for these caregivers such as illness that limits     the caregiver's activities, new household management and caregiving responsibilities,     satisfaction with social roles and activities, lifestyle constraints, the quality of the     marital relationship, perceived social support, and demographic factors. A secondary aim of     the proposed study is to determine which of a series of key caregiver sociodemographic     factors moderate PST- intervention efficacy for caregiving burden and mental health QOL     outcomes   "
5636|NCT03212118|"     Long-term sickness absence has considerable impact on social functioning, families involved,     the employer, and society as a whole. Preventing long-term sickness absence and increase the     likelihood of return to work (RTW) are critical concerns for industrialized countries across     the world. Motivational factors contributing to RTW and maintenance of work participation are     therefore of importance to explore in order to get the person back to work after long-term     sick leave. Motivational interviewing (MI) is an empirically validated psychological approach     that may be particularly useful in a RTW context. Even though MI has been widely studied and     is considered a flexible intervention strategy in different domains, its effectiveness in     improving RTW has not yet been studied.      The aim of this study is to evaluate whether MI provided by trained caseworkers at The     Norwegian Labour and Welfare Administration (NAV) to sick-listed users with unselected     diagnoses facilitates RTW compared with follow-up as usual.   "
5637|NCT03212105|"     The purpose of this study is to determine within a randomized controlled trial the     feasibility of a 60-second acceptance based mindfulness exercise for patients with     musculoskeletal pain versus usual medical care. Feasibility will be evaluated as the number     of individuals approached who agree to participate and the number of individuals who drop out     prior to completion of post intervention questionnaires.      The investigators aim to determine the usefulness and acceptability of the 60-second     acceptance based mindfulness exercise for patients with musculoskeletal pain as compared to     usual medical care. Usefulness and acceptability will be assessed with the Client     Satisfaction Scale-3 (CSQ-3).      The investigators also aim to determine whether participating in a personalized 60-second     acceptance based mindfulness exercise (e.g., intervention) is associated with significantly     more improvement in patients' ratings of state anxiety and pain intensity (co-primary     outcomes), and to determine if Distress, Anxiety, Depression and Anger (secondary outcomes)     decrease compared to a brief educational pamphlet (e.g., control).      The investigators also aim to determine whether any improvements observed will maintain     within a 3 month follow up.   "
5638|NCT03212092|"     The study is an randomised controlled trial (RCT) to test whether supplementation of     vitamins, minerals and n-3 fatty acids may reduce aggressive behavior in people with     intellectual disabilities.   "
5664|NCT03211754|"     In this work, the investigators report the effects of consume of 15g walnuts and 15g almonds     for 8 week on weight, waist and hip circumferences, body mass index, fat mass, serum     LDL-cholesterol adiponectin, lipocalin-2 concentration and fatty acids profile.   "
5641|NCT03212053|"     There is no prospective study published on the Essential Thrombocythemia and the correlation     between this specific disease, its complications and the biological variations observed.      The aim of this study is to demonstrate a correlation between biological tests of     haemostasis, as Multiplate analyser and thromboelastometry (ROTEM) and the occurrence of     clinical complications, thrombosis and/or haemorrhage, in order to determine if this     biological tests could be biological prognostic factors   "
5642|NCT03212040|"     Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast     biopsies   "
5643|NCT03212027|"     The aim of this study is to analyze aquaporins expression of thymic epithelial tumors and to     compare them with apparent diffusion coefficient(ADC) from ultra-high b-values, and to test a     possibility of use of ADCuh to identify the pathological type of tumor.   "
5644|NCT03212014|"     The present study aims to compare the clinical efficacy of intelligent POWER therapy,     intelligent LSVT-BIG therapy, and the three exercise models currently in clinical use. DCM_IR     analysis will also be incorporated into the analysis to develop a personalized and     intelligent Parkinson's rehabilitative therapy platform.   "
5645|NCT03212001|"     The goal of this study is to evaluate the overall impact of Telehomecare on COPD and HF     patients and system level outcomes using a comparison group of patients that did not     participate in the program (for up to 18 months). This evaluation study will explore costs,     participants' experiences, perceptions, and patterns of use related to Telehomecare. The     study will include eight Local Health Integration Networks (LHINs) across Ontario, Canada.   "
5646|NCT03211988|"     This is an open-label, single arm, multi-center Phase II trial of entinostat given as a 5 mg     oral dose every week (days 1, 8, 15, and 22 of a 4-week cycle) in patients with relapsed or     refractory abdominal neuroendocrine (NE) tumors. Patients will continue on treatment until     disease progression or intolerable toxicity occurs.   "
5655|NCT03211871|"     The aim of this study was to evaluate efficacy and safety of dexmedetomidine infusion during     laparoscopic cholecystectomy. The randomized, single-center, controlled study was carried out     from May 2016 to June 2017 at department of surgery, anesthesiology and intensive care,     Postgraduate Institute of Bogomolets National Medical University.   "
5656|NCT03211858|"     Primary Objective:      To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin     A1c (HbA1c) change from baseline to Week 26 in patients with type 1 or type 2 diabetes     mellitus (T1DM or T2DM) also using Lantus®.      Secondary Objectives:        -  To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of          positive/negative status and anti-insulin antibody (AIA) titers during the course of the          study.        -  To assess the relationship of AIAs with efficacy and safety.        -  To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of          patients reaching HbA1c <7.0% and change in HbA1c, fasting plasma glucose (FPG), and          self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only          Week 52 for HbA1c).        -  To assess safety of SAR341402 and NovoLog/NovoRapid.   "
5647|NCT03211975|"     Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in     the endocardium. It remains a complicated disease to manage due to its low incidence,     diagnostic difficulties, the change in epidemiology in recent decades and high mortality     rates. The annual incidence is estimated at 3-10 cases per 100,000 people.      The epidemiology of AR has changed significantly in recent years due to new risk factors.     Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor,     decreased markedly in the industrialized countries, replaced by new predisposing factors: the     presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50     Compared with the general population), hemodialysis, nosocomial infections,     immunosuppression, increased use of injectable treatments and, above all, an aging population     with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency.      The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes     atypical especially in case of infection on prosthesis where the diagnosis is based mainly on     the results of the blood cultures and the ultrasound data.      The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and     fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the     native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation.      The evolution of endocarditis and its prognosis vary according to many factors: the type of     germ responsible, the precocity of the diagnosis, the existence of a complication, the site     of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is     complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses,     embolic, neurological, renal and septic complications. Despite improvements in diagnosis and     therapeutic methods, diagnosis is sometimes difficult, management remains very complicated     and morbidity and mortality remain high. Studies are still needed to study the prognosis and     to determine the predictive factors for hospital mortality and long-term mortality.   "
5648|NCT03211962|"     Transient renal insufficiency is frequently observed in the course of cardiovascular arrest.     Although elevation of creatinine is reversible in a large majority of cases, severe renal     insufficiency is sometimes observed and is associated with a dark prognosis. Any intervention     that may limit the worsening of renal function may have an impact on patient mortality. There     is currently no validated pharmacological treatment to limit the progression of ARI or to     accelerate its recovery. A major challenge then concerns the detection of the reversible     character of renal damage.      Renal biomarkers have been little studied in the prediction of severe ARI and mortality after     cardiac arrest. The combination of TIMP2 (tissue inhibitor of metalloproteinase) and     insulin-like growth factor binding protein (IGFBP7) in urine showed good diagnostic     performance in the early detection of the risk of developing acute renal failure within 12     hours. Measured in the urine, the excretion of these two markers specifically reflects renal     tubular lesions. Moreover, their rate seems to be strongly correlated with the severity of     the tubular lesions.      Thus, it can be reasonably assumed that their very early dosing in post-cardiac arrest could     detect the presence and severity of renal tubular lesions. A threshold to be defined would     discriminate patients at risk of developing an ARI within 48 hours post ACR and to     distinguish between severe transient and severe persistent lesions beyond 72 hours.   "
5649|NCT03211949|"     Blocking the medial antebrachial cutaneous nerve (MACN) during an axillary block often a     subcutaneous wheal of local anesthetics is made what is described as painful. With the     improvement of the resolution of the ultrasound machines smaller structures and nerves can be     visable. In this study topographic assessment will made of the anatomical variation of the     medial antebrachial cutaneous nerve (MACN) by ultrasound in the axilla and 5 cm above the     cubital fossa of the arm.   "
5701|NCT03211273|"     In the LIFT study 2000 cancer patients will be recruited at 6 months after diagnosis and     extensively surveyed over five years on factors that are associated with fatigue.   "
5650|NCT03211936|"     Patients submitted to general anesthesia and artificial ventilation almost always develop     pulmonary atelectasis, which can determine adverse consequences both intraoperatively and     postoperatively. It is recommended to use physiological tidal volume (6 - 8 mL / kg of ideal     body weight) during the intraoperative period in order to minimize the risk of lung injury.     To prevent the formation of atelectasis, minimizing the risk of complications, the use of     PEEP has been recommended. At present, there is no way to make an optimal adjustment of PEEP     to the needs of each patient, seeking a value that keeps the alveoli open without forming     atelectasis and also without areas of hyperdistension.      The aim of this study was to evaluate the agreement between the ultrasound and the electrical     impedance tomography - Timpel® (TIE) to detect the beginning of the formation of areas of     atelectasis after pulmonary recruitment, with decreasing PEEP values. In addition, the lung     ultrasound will be validated for intraoperative use for both adequacy of PEEP, as well as     quantitative analyzes of ultrasound images to assess atelectasis.      17 patients (> 18 years) of both sexes, submitted to general anesthesia, will be     prospectively studied. All patients will receive, in addition to the usual monitoring, the     monitoring with the electrical impedance tomography and chest ultrasonography, after being     anesthetized and under neuromuscular block, being ventilated with an inspired fraction of 50%     oxygen (or greater to maintain oxygen saturation > 96% ), Tidal volume of 6 mL / kg and     respiratory rate to maintain expiratory tidal CO2 between 35-45 cmH2O.   "
5651|NCT03211923|"     The aim of this study is to quantify muscle relaxation properties of the finger flexor     muscles in patients with different myopathies. The inhibiting effects of transcranial     magnetic stimulation (TMS) on the cortical motor hand area are used to induce relaxation,     which in turn will be monitored with handgrip dynamometry and EMG. The investigators will     evaluate if this technique can be implemented as a diagnostic tool in clinical practice.      Muscle relaxation is an often overlooked property of the muscle as compared to muscle     strength or activation. Muscle relaxation is affected in different myopathies, such as     myotonic dystrophy, non-dystrophic myotonias, and Brody myopathy. Therefore, a diagnostic     tool to quantify muscle relaxation is of clinical and scientific importance. In this study,     transcranial magnetic stimulation (TMS) is used, in combination with a dynamometer to     quantify muscle relaxation properties.      Transcranial magnetic stimulation (TMS) is a non-invasive technique that is commonly used to     stimulate the brain. In practice, a circular coil is held directly above the scalp, upon     which a strong current pulse induces a magnetic field that stimulates the underlying     superficial brain areas. This stimulation can have both activating and inhibiting effects.      When the motor cortex (i.e. the area of the brain that controls muscle contractions) is     strongly stimulated with TMS during a voluntary muscle contraction, both excitatory and     inhibitory effects can be observed in the muscle the targeted cortical area controls. The     inhibitory effect entails a transient interruption of neural drive to the muscle. This     interruption, called the silent period, lasts for less than half a second and results in     the relaxation of the muscle. Muscle activity and control quickly return to normal after the     silent period.      The elegance and main advantage of TMS-induced muscle relaxation lies in the fact that it     excludes all voluntary influences on the relaxation process. Furthermore, the TMS pulse     causes all muscle fibres involved in the contraction just prior to the onset of the silent     period to relax simultaneously. This allows us to study muscle relaxation as only a property     of the muscle, i.e. without voluntary influences.      In this study, the investigators will measure muscle relaxation in several myopathies     (McArdle disease, Nemaline myopathy type 6 and myotonic dystrophy type 2) and compare this to     healthy controls and to controls with no myopathy but with similar complaints (myalgia,     stiffness, cramps). The data from these two control groups has been gathered previously in a     different study. The investigators will also compare this to patients suffering from Brody     disease who were previously measured in a different study.      Muscle relaxation will be evaluated in fresh and fatigued finger flexor muscles. The main     outcome of this study is the peak relaxation rate normalized to the peak force preceding     relaxation.      The final outlook of this research is to evaluate whether muscle relaxation studied with TMS,     can be used for different myopathies as a diagnostic tool, to monitor disease progression,     and to study the effects of different interventions (e.g. medication, exercise).   "
5652|NCT03211910|"     The purpose of the study is to investigate the ability of the product Sacral Saver, to     prevent and /or help healing bed sores.   "
5653|NCT03211897|"     The goal of this research investigation is to conduct a prospective observational study of     the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone     for the treatment of acute undifferentiated agitation in the emergency department.   "
5657|NCT03211845|"     An optimal nutritional status is essential for healthy ageing. Telemonitoring might     contribute to maintaining or improving nutritional status in elderly people.The objectives of     this pilot study are to test the feasibility, acceptability and implementation fidelity of     telemonitoring of nutritional parameters in community-dwelling older adults; to test the     study procedures for effect evaluation; and to determine the likelihood of achieving desired     impact on the primary and secondary outcomes.   "
5658|NCT03211832|"     The purpose of this study is to identify and evaluate dissemination strategies to support the     uptake of evidence-based programs and policies (EBPPs) for diabetes prevention and control     among local-level public health practitioners. Dissemination strategies such as multi-day     in-person training workshops, electronic information exchange modalities, and remote     technical assistance are hypothesized to associate with improved access and use of public     health evidence and organizational supports for program and policy decision making based on     evidence-based public health.   "
5659|NCT03211819|"     Patients with fractured anterior teeth indicated for extraction will be recruited to the     study. After Extraction of the tooth the socket will be evaluated and if eligible for     immediate implant placement, implants will be placed either by free hand or computer guided     technique. The pink esthetic score will be evaluated to be the primary outcome.   "
5660|NCT03211806|"     The goal of this research is to develop and test a technology-supported intervention to     reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at     elevated risk for postoperative complications and readmissions. Sedentary behavior increases     markedly after surgery and hospitalization, and reducing sedentary behavior around the time     of cancer surgery could reduce risk while also empowering cancer patients to take a more     active role in their recovery.   "
5661|NCT03211793|"     The MANUS Trial aims to examine the safety, feasibility and potential efficacy of     intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers     of systemic sclerosis.   "
5662|NCT03211780|"     Using the analysis of group velocity for a screening application and then higher order     analysis based on the elastic and viscious components of the shear modulus may allow     discrimination between extent of tumor invasion through the esophageal wall if appropriately     correlated with pathological findings.   "
5663|NCT03211767|"     The primary objective of this trial is to assess the effect of consumption of aged garlic     extract powder on 24 h systolic and diastolic ambulatory blood pressure in hypertensive     individuals following 8 weeks of supplementation.      Additional secondary objectives are to assess the effects of aged garlic extract powder     intake for 8 weeks on lipid profile (TC, HDL-C, LDL-C, and TG concentrations), blood glucose,     office blood pressure, pulse-wave velocity and augmentation index, body mass index, and waist     and hip circumference.   "
6905|NCT03195491|"     The purpose of this study is to investigate the safety of patients in Asia with Non-Small     Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third     line treatment.   "
5665|NCT03211741|"     Although the safety and efficacy of bevacizumab has been established in several phase 3     trials, there is only little documented about the long-term safety and efficacy in the     'real-world practice' in large populations from different regions.      Therefore the investigators evaluate the long-term safety and efficacy of intravitreal     treatment with bevacizumab by registration of best corrected visual acuity, side-effects and     central retinal thickness as measured with the ocular coherence tomography if available. This     will allow the investigators to compare the results of their centre with the results of     several phase 3 trials from the literature and will guide improvements in their treatment     protocols.   "
5666|NCT03211728|"     The investigators hypothesize that perioperative oral administration of pregabalin would     reduce postoperative pain and produce reduction in postoperative opioid consumption after     anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2     groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after     initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same     points.   "
5667|NCT03211715|"     In contemporary era of rectal cancer treatment, development of surgical technique and tool,     adaptation of chemoradiation therapy, as well as multidisciplinary approach have led     increased survival as well as rate of sphincter preservation. However, poor anorectal     function, such as fecal incontinence and/or urgency, has also been increased. Such anorectal     dysfunction is named as low anterior resection syndrome, and its rate has been reported in 40     to 90% in rectal cancer patients who received sphincter preserving surgery. Low anterior     resection syndrome is known to debilitate quality of life in survivors of rectal cancer.     Previously, several studies attempted to evaluate the low anterior resection syndrome via     questionnaires and scoring system. Adapting the low anterior resection syndrome score system     created in Denmark, this study investigates the validity of the scoring system in Korean     language.   "
5668|NCT03211702|"     This study will validate the impact of comprehensive geriatric assessments using activity of     daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity     index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma     (DLBCL) treated with R-CHOP.   "
5669|NCT03211689|"     This aim of this research project is to determine if low to moderate level exercise can have     an impact on stress, fatigue, and quality of life for individuals diagnosed with a primary     immunodeficiency disease. This 8-week study will compare participants engaging in a     semi-customized, home exercise program (exercise intervention group) to participants     performing normal activities (non-exercise control group). This study will track stress,     fatigue, and quality of life in individuals with a diagnosis of primary immunodeficiency     disease, using standardized questionnaires, journals, and interviews.   "
5670|NCT03211676|"     The aim of this study is to evaluate the removal of midle molecules and inflammatory     cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high     flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.      Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also     be carried out.      Finally, the investigators will compare hepcidin levels and the erythropoietin resistance     index between the two groups.   "
5675|NCT03211611|"     The aim of this study is to determine general practitionners' role in management of women     with BRCA1/2 mutation.      This study will be conduct between April 2017 and December 2017 at Montpellier University     Hospital on women followed-up in the department of genetics and their general practitionners     (GP). Patients and their GP will be called by the investigators and questionnaire will be     given to them. Questionnaire includes questions for patients and their GP. The primary     endpoint was to determine the rate of GP having sufficient knowledge of the adequate     management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic     search for a family history of cancer, knowing criteria required to refer women in     oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint     was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 /     2 mutation.   "
5676|NCT03211598|"     The purpose of this study is to determine the feasibility and safety of the Surefire Infusion     System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in     the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in     terms of disease response.   "
5677|NCT03211585|"     The purpose of this study is to further quantify the safety and effectiveness of the     Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta     V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and     blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of     rosacea with less bruising or purpura and greater effectiveness than previous generation     systems. This study should enable optimization of treatment parameters for using the Perfecta     595nm laser for treating rosacea.   "
5678|NCT03211572|"     Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy     Response in Hormone Receptor Positive Breast Cancers   "
5679|NCT03211559|"     The aim of our study is to investigate the effect of Clinical Pilates Exercises on functional     status and quality of life when applied together with aerobic exercise in patients with     ankylosing spondylitis (AS).   "
5680|NCT03211546|"     Prospective data collection and evaluation of complete data sets will be performed in the     course of routine clinical care of a cohort of consecutive patients (children up to 16 years     old) presenting with an isolated femur shaft fracture. Data will be collected during     follow-up visits at 3 to 6 weeks, 3, 6, 12 and 24 months, with additional follow-up visits as     needed or dictated by individual practice. Final follow-up will be at 24 months, unless a     patient requires additional follow-up or another intervention to address an unfavorable     outcome (e.g. malalignment, nonunion, limb length discrepancy) noted at the 24 month     follow-up visit.   "
5716|NCT03211078|"     With the increased incidence of lung cancer and prevalence of low dose CT screening, treating     of early lung cancer has becoming an important issue in the clinical practice of thoracic     oncology. In this clinical study, the investigators will evaluate whether superDimension     (superD) ENB (Electromagnetic navigation bronchoscopy) in combination with interstitial     photodynamic therapy can provide the chance of tumor eradication.   "
5681|NCT03211533|"     This observational study aims to early identify, through a rigorous and standardized     follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the     parents, infants born at term or preterm with ultrasonographic evidence of brain injury     considered at risk for neurodevelopmental disorders will be strictly monitored during the     first months of life performing a periodic neurological assessment (Prechtl's General     Movement (GMA) and the Hammersmith Infant Neurological Examination) at term age and around 3     months of post term age. Moreover, to study more accurately the brain injury early identified     by ultrasonographic brain exam, around 6 weeks of post-term age the enrolled infants will     perform, as recommended in infants at risk, brain Magnetic Resonance (RM).      Thanks to the high predictability power of the combination of the clinical observation with     the neuroimaging infants at high risk of CP will be early detect. Selected infants,     considered at high risk for CP will have the opportunity to perform an home based and family     centered early intervention later than 3 post term age.   "
5682|NCT03211520|"     The study is being conducted to see which cardiac tests that monitor how the heart functions     during and after treatment with anthracyclines are most effective. This study will assess a     new way to check the heart function of children during and after cancer treatment. Currently,     doctors use echocardiograms (heart ultrasound) to see how the heart is working.     Echocardiograms are currently being done as part of standard of care prior to giving     anthracycline chemotherapy doses and if any cardiac problems are suspected. The new method     involves Cardiac Magnetic Resonance Imagining (CMRI) and a blood tests for certain biomarkers     for heart health: High sensitivity troponin, Caspase, C-reactive Protein (CRP), ventricular     derived B-type natriuretic peptide (BNP), Matrix Metalloproteinases (MMPs), Tissue inhibitors     of metalloproteinases (TIMPs), C terminal propeptide of type I procollagen (PICP), C terminal     telopeptide of collagen type I (CITP), Troponin I, and Bone Alkaline Phosphatase. The purpose     of this study is to find out if CMRI and blood tests help us to find heart problems earlier,     before they are detected by echocardiograms.   "
5683|NCT03211507|"     A case-control study to investigate whether job exposures are an under-recognized cause of     idiopathic pulmonary fibrosis (IPF) using an interview to collect information about previous     jobs and a blood test to investigate genetic susceptibility.   "
5684|NCT03211494|"     The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP     levels during INTELLiVENT®-ASV with conventional lung protective ventilation in the acute and     sub-acute phase of moderate or severe ARDS.      A total of 48 adult patients admitted to intensive care units with moderate or severe ARDS     will be included. In the acute phase patients will receive 4 hours of INTELLiVENT-ASV     ventilation and 4 hours of conventional lung protective ventilation in random order. After     these two blocks the patients are allocated into either the INTELLiVENT-ASV arm or the     conventional lung protective ventilation arm.      in the sub-acute phase patients will be assessed every day until day 7 or extubation,     whichever comes first.      Primary endpoint is the transpulmonary transpulmonary (ΔP). Secondary endpoints of both     studies include other ventilator settings and ventilation parameters, as well as time spent     at a ΔP level of 15 cm H2O or higher.   "
5755|NCT03210571|"     This study aims to test a new medical device, called the eyeWatch, used in filtering surgery     for the treatment of glaucoma. This medical device has the following property: it allows     better control of intraocular pressure in the initial postoperative phase by adjusting     aqueous flow going through the device. The target criteria for the study are defined as:     keeping intraocular pressure in target range; reducing the number of anti-glaucoma drugs;     evaluating the number and type of postoperative complications. So far, this device has been     already tested on 20 patients in Switzerland.   "
5685|NCT03211481|"     Uterine fibroids are benign uterine masses that can be removed through a surgical procedure     called a myomectomy. Myomectomy is often associated with a significant amount of blood loss     for the patient. The large volume of blood lost can increase post-operative complications and     lead patients to require blood replacement (blood transfusion). To reduce the amount of blood     lost during the surgical procedure and the need for blood transfusions, interventions such as     medications and surgical techniques have been used. While evidence in the literature exists     for these techniques, there is no standardized approach to this problem in clinical practice.     The objective of this study is to create a novel intra-operative blood conservation pathway,     using a modified Delphi expert consensus approach, to decrease the amount of blood lost     during myomectomy.      The current study is expected to benefit patients undergoing myomectomy through an improved     surgical experience, reduction in blood transfusion rates, and reduction in associated     complications.   "
5686|NCT03211468|"     A controlled, randomized clinical intervention study which includes the development and     activation of an intervention program designed to prevent eating disorders among adolescent     female aesthetic athletes. Our hypothesis is that the intervention program will yield     improvement in the participants' eating behaviors, drive for thinness, and body image as     compared with the age matched control group. Results will be measured using the study     questionnaire, to be filled out by the participants before, after, and three months after the     completion of the program. The Questionnaire will include validated questionnaires with good     psychometric qualities.   "
5687|NCT03211455|"     Although peroperative intravenous lidocaine has been shown to be useful in early recovery     after colorectal surgery, its beneficial effect on the specific population of obese patients     scheduled for bariatric surgery remained unknown.      Investigators hypothesized that peroperative intravenous lidocaine could decrease     postoperative opioid consumption and improve postoperative recovery   "
5688|NCT03211442|"     MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac     structures and the risk of acute coronary events (ACE) and other cardiac complications in     breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue     Complication Probability (NTCP) models to assess the risk of ACE in individual patients based     on cardiac dose metrics in the first 10 years after BC radiotherapy.   "
5717|NCT03211065|"     To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy     (replacement of antibodies, which are infection-fighting proteins) in patients with a type of     blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy)     and have an abnormal immune system putting them at increased risk of infection.   "
5689|NCT03211429|"     Fear of falling is a major health problem among community-dwelling older adults that may     contribute to avoidance of activities that they are capable of performing. Studies show that     the fear of falling may lead to a continual, complex decline in older adults that includes a     loss of auto efficacy, restriction of physical activities and social participation, physical     frailty, falls and disability. Apart from these effects, the fear of falling may also have     financial implications for health care systems and the general public. Several interventions     have been shown to reduce fear of falling with multifactorial interventions, including     physical and behavioral components, being most successful. Behavioral components usually     comprise strategies to reduce catastrophic thinking and fear-related avoidance behaviors     while physical components usually comprise falls prevention exercise programs. However,     multifactorial programs are not always feasible or preferred by older people. In this     framework, the objective of this works is to assess the effects (benefits and effectiveness)     of three interventions programs (Tai Chi, postural control exercises and behavioral therapy     intervention) to improve functionality and decrease fear of falling in older people living in     the community.   "
5690|NCT03211416|"     This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating     patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells     to grow and spread. Giving sorafenib tosylate and pembrolizumab may work better in treating     patients with liver cancer.   "
5691|NCT03211403|"     This is a single-Center, randomized, double-Blind, placebo-controlled, multiple     ascending-dose Phase I trail.   "
5692|NCT03211390|"     The purpose of this study is to test the reliability of using telemedicine so a neurologist     can remotely identify residents of a long-term care facility who should be referred to a     neurologist for an in-person spasticity consultation.   "
5693|NCT03211377|"     This is a non-interventional study to observe the safety and efficiency of chemotherapy for     potentially resectable locally advanced esophagogastric junction   "
5694|NCT03211364|"     One of the main complications after stroke is hemiplegic shoulder pain. It is known that one     of the most frequent causes of hemiplegic shoulder pain is a restricted range of motion in     the shoulder joint. Therefore, it is necessary to preserve the passive range of motion by     using the most optimal mobilization technique. The aim of this study is to compare 2     different techniques in order to document their influence on shoulder range of motion and     shoulder pain in stroke patients.   "
5695|NCT03211351|"     With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been     developed in which phospholipid liposomes are delivered to the tear film via the surface of     the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte     application on the lipid and stability of the tear film in dry eye patients   "
5697|NCT03211325|"     The investigators seek to perform a comparative transcriptome analysis of TRP channels     residing in the skin between primary and scleroderma secondary Raynaud's phenomenon and     healthy subjects.   "
5698|NCT03211312|"     This study intends to investigate the relevant risk factors of perioperation complications or     mortality in older patients with cardiac diseases undergoing teeth extraction surgery and     this study aims to quantify the risk factors and then to establish the predictive scoring     systems.      Hypothesis:Preoperative parameters could predict postoperative complications.   "
5776|NCT03210298|"     Multicentric, international, web-based prospective documentation of the indications and     results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant     pleural and peritoneal diseases. Indication is decided by the treating physician. There are     no predefined inclusion or exclusion criteria.   "
5699|NCT03211299|"     Excessive fat in the liver, in absence of high alcohol consumption, is diagnosed as     non-alcoholic fatty liver (NAFL). NAFL prevalence is as high as 50-70% in obese people and is     associated with impairments in metabolic health, e.g. insulin resistance. Not only the     amount, but also the composition of the fat stored in the liver appears to be linked to     health outcome measures, such as insulin resistance, but this evidence comes mainly from     animal studies. Since fat composition has been linked to health outcome measures, it is     important to understand what determines the fatty acid composition of liver fat. De novo     lipogenesis (DNL) and adipose tissue fat composition are factors that could determine liver     fat composition. Since the end product of DNL are saturated fatty acids and as the majority     of fatty acids in the liver originate from adipose tissue, both may influence hepatic fatty     acid composition profoundly. Here, our primary hypothesis is that DNL is associated with the     relative amount of saturated fatty acids in the liver in overweight/obese humans differing in     liver fat content. Furthermore, we hypothesise that adipose tissue fat composition is     associated with liver fat composition and that liver fat composition is associated with     liver, muscle and whole body insulin sensitivity in overweight/obese humans differing in     liver fat content. To this end, liver fat composition, adipose tissue fat composition, DNL     and insulin sensitivity will be measured in overweight/obese participants differing in liver     content.   "
5700|NCT03211286|"     Studies have shown that hip fractures have a significant perioperative blood loss.     Postoperative anaemia is associated with a higher morbidity and mortality.      Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in     other forms of orthopaedic surgery and in traumatized patients. However, evidence on the     effectiveness of TXA in lower extremity fracture care is more limited.      Hip fractures represent a common orthopedic injury in a fragile patient population that often     necessitates post-operative blood transfusion thereby putting the patient at additional risk     of complications.      The goal of this study is to assess if the use of tranexamic acid in patients with hip     fractures will result in a reduction in blood losses and blood transfusion rates.      Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the     amount of preoperative and intraoperative bleeding thereby leading to a decreased need for     postoperative transfusion.      This a double blinded, placebo controlled, therapeutic trial in which the patients will be     randomized to receive TXA or a placebo (saline solution). Treatment will be administered     pre-operatively as well as at the time of surgical incision. The primary outcome will be need     for blood transfusion. Secondary outcomes will include calculated perioperative blood loss,     length of stay, and rate of thromboembolic events, and 90 day mortality.   "
5702|NCT03211260|"     Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes     falls, and impairs quality of life. Therapeutic options for this symptom are limited and of     limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive     sensitivity is likely to play a role and recent studies have reported that high-frequency     microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits     and could be considered a valuable treatment strategy. However, evidence is not available.     The present study was designed to collect preliminary evidence of efficacy of a vibrotactile     device (Equistasi) for the treatment of FOG.   "
5703|NCT03211247|"     The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization     to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by     EPicutaneous ImmunoTherapy (EPIT).   "
5704|NCT03211234|"     To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and     high dose) given in combination with Lucentis® in subjects with wet age-related macular     degeneration (AMD) compared with Lucentis® alone.   "
5705|NCT03211221|"     The aim of this study is to investigate the effectiveness of low-frequency (1Hz) rTMS     (repetitive transcranial magnetic stimulation) over the pre-SMA (pre-supplementary motor     area) in a sample of treatment-resistant OCD patients in a multicenter, controlled design.   "
5706|NCT03211208|"     A panel of highly sensitive circulating biomarkers for acute liver injury have been     identified and demonstrated to identify liver injury on first presentation to hospital before     standard tests are elevated in patients with paracetamol overdose. The investigators wish to     test these biomarkers in patients with active and latent tuberculosis to see if they can be     used to stratify patients undertaking anti-tuberculosis drug therapy. Anti-tuberculosis drug     induced liver injury is the most frequent side-effect of anti-tuberculosis therapy, affecting     2-5% of tuberculosis patients seen at the Royal Infirmary Edinburgh and hindering their     effective treatment. Patients will be recruited from the TB out-patient clinic at the Royal     Infirmary Edinburgh. Blood samples will be taken every time the patient visits the clinic and     also retrieved from the biochemistry lab. The biomarkers in the blood samples will be     analysed to determine if they rise in patients who develop liver injury.   "
5707|NCT03211195|"     Primary Objective:      To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin     (test) compared to the development tablet of sotagliflozin (reference) under fasting     conditions in healthy male and female subjects.      Secondary Objectives:        -  To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite          sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test)          tablet or a single sotagliflozin (reference) table in healthy male and female subjects          under fasting conditions.        -  To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet          compared to a single sotagliflozin (reference) tablet administered under fasted          conditions in healthy male and female subjects.   "
5708|NCT03211182|"     The lifestyle intervention program focusing on healthy dietary habit and exercise effectively     prevents progression to diabetes. Thus, the purpose of this study was to assess the     effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.   "
5709|NCT03211169|"     Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of     bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies     for obtaining diagnostic tissue from biliary strictures.   "
5710|NCT03211156|"     This is a randomized, double-blind, placebo-controlled Phase II study designed to determine     if amoxicillin will eradicate vaginal colonization/infection with Gardnerella vaginalis (GV)     when administered to women who are colonized/infected with GV but have no clinical evidence     of Bacterial Vaginosis (BV). The study will be conducted at 2 clinics in the United States:     University of Alabama at Birmingham and Wake Forest University Health Sciences. Entire study     duration is approximately 10 months and subject participation duration is approximately 15     days. Approximately 245 healthy adult females, 18 to 45 years of age will be screened to     enroll approximately 98 participants to achieve 82 evaluable participants at the test of cure     (ToC) visit. Participants will be enrolled and randomized to one of two groups, either     amoxicillin (2 x 250 mg capsules by mouth twice daily for 7 days) or placebo. Women who are     enrolled will be asked to return for one further visit, Visit 2 (Day 15 - 21), where a ToC     will be completed. For those not enrolled, participation will end at their post screening     follow up phone call. Women will be asked to use condoms during their participation. The     primary objective is to determine if treatment with amoxicillin eradicates GV in women who     are colonized/infected with GV but have no clinical evidence of BV.   "
5711|NCT03211143|"     A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in     healty subjects   "
5712|NCT03211130|"     This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention     in older adult stroke survivors to improve medication adherence. Half the participants will     receive the SystemCHANGE intervention, while the other half will receive the     attention-control education intervention.   "
5713|NCT03211117|"     This phase II trial studies how well pembrolizumab, chemotherapy, and radiation therapy work     with or without surgery in treating patients with anaplastic thyroid cancer. Monoclonal     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and     spread. Drugs used in chemotherapy, such as docetaxel and doxorubicin hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy     x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, chemotherapy, and     radiation therapy with or without surgery may kill more tumor cells and work better in     treating patients with anaplastic thyroid cancer.   "
5714|NCT03211104|"     This was a placebo-controlled, double-blind, randomized trial designed with the aim of     establishing whether curcumin influenced the duration of treatment interruption and rate of     prostatic specific antigen(PSA) progression, compared with placebo among men with prostate     cancer receiving intermittent androgen deprivation therapy.   "
5715|NCT03211091|"     Patients with stroke were registered based on the WHO/ MONICA protocol and were followed-up     for 28 days, starting in 2015 in PROVE Registry   "
5718|NCT03211052|"     This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy.     The three year biochemical free survival is the primary endpoint. There are a number of 2nd     endpoints such as pathological complete response rate, the need for adjuvant radiation     therapy, use of post operative radiotherapy an the rate of positive margins at surgery.     Translational endpoints include measuring tumoural and plasma testosterone as well as other     androgens.      Patients with untreated high risk and intermediate risk operable prostate cancer will be     treated with TAK-700 (plus LHRH agonist) for 24 weeks prior to planned prostatectomy.   "
5719|NCT03211039|"     This study will seek to determine if rapid genomic sequencing improves outcomes for acutely     ill infants. The investigator will enroll up to 1,000 acutely ill infants in a prospective,     randomized, blinded study to either rapid Whole Genome Sequencing (WGS) or rapid Whole Exome     Sequencing (WES, which is 2% of the genome and ~4-fold less expensive). Outcomes will be     measured both by objective clinical measures and family perceptions (patient/family centered     outcomes). Primary analysis of WGS or WES will be in infants alone. Secondary analysis, in     infants who do not receive a diagnosis, will be of families - ideally trios (mother, father,     and affected infant), which is ~2-fold more expensive. Trios will be analyzed within the same     randomization arm (WGS or WES). This study is designed to quantify which acutely ill infants     benefit from rapid genomic sequencing, by how much they benefit, how they benefit, which     rapid genomic sequencing method is superior, and the cost effectiveness of such testing.   "
5720|NCT03211026|"     The purpose of this study is to better estimate the prevalence of urinary tract infections     (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR)     bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the     transplantation. Urine culture was done in a city lab or at hospital. Current data on     bacteriuria and candiduria lead mostly to hospital data that are incomplete..   "
5721|NCT03211013|"     The investigators will test whether intranasal oxytocin (24 IU vs placebo) will induce     effects on attention bias and startle comparable to those the investigators have shown to be     induced by the presence (vs absence) of a service dog in Veterans diagnosed with PTSD. This     possibility is suggested by a 2015 study showing that urinary oxytocin levels are elevated in     association with mutual gaze between dogs and their owners.   "
5777|NCT03210285|"     Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated     vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into     the complete genome of the NF2 associated VS compared to sporadic VS (control group). These     data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically     evoked potentials) and the clinical picture as well as the tumor growth rate and general data     such as sex, age, side, etc.   "
5722|NCT03211000|"     The molecular mechanisms contributing to the development of aortic aneurysmal disease are     poorly characterized making actual therapies not sufficient. Autophagy is an intracellular     mechanism that removes dysfunctional organelles and unfolded proteins, thereby maintaining     cellular homeostasis. Activation of autophagy was shown to limit cardiac damage during     stress. Accordingly, autophagy was found to be inhibited in the heart in animal models of     metabolic syndrome, diabetes, obesity and aging thereby contributing to the development of     cardiac derangements associated with these conditions. However, it remains to fully dissect     the association between autophagy and structural alterations of the aortic wall and     endothelial dysfunction in humans. In this study the correlation between levels of autophagy     and the development of human aortic aneurysm will be assessed in patients subjected to     surgical interventions for aortic pathologies. The association of Hippo signaling activation     with the formation of aortic disease will also be evaluated, since previous work demonstrated     that the Hippo pathway negatively regulates autophagy and promotes the development of     cellular abnormalities. The results of this study may provide new insights into the     mechanisms underlying the development of aortic disease.   "
5723|NCT03210987|"     Patient case presentations during ward rounds can take place at the bedside or outside the     room. The best approach to patient case presentation is yet unclear. Thus, the overall aim of     this multicenter, randomized-controlled study is to test the hypothesis that outside the room     patient case presentation compared to bedside patient case presentation results in better     outcomes across different dimensions including patient understanding and perception of     quality of care as well as patient outcomes, physicians' preferences, perception of quality     and effectiveness, and timing of the ward rounds, respectively.   "
5724|NCT03210974|"     This study is a non-interventional (NIS), multicenter, retrospective cohort study, which will     obtain data from patients diagnosed with invasive breast cancer between 2002 and 2005 in the     medical oncology departments of hospitals that are members of GEICAM (using information     obtained from patient medical histories).   "
5725|NCT03210961|"     This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and     pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.   "
5726|NCT03210948|"     Diagnostic assessment of solid pancreatic lesions may represent a real challenge in the     clinical practice, even with the aid of tissue sampling by means of endoscopic ultrasound     (EUS) fine needle aspiration (FNA).      Aim of this multicenter randomized controlled trial (RCT) is to establish the diagnostic     accuracy, sensitivity, and specificity of real time elastography (RTE)-guided EUS-FNA as     compared to conventional EUS-FNA in a series of patients with solid pancreatic masses.      Eligible will be patients with solid pancreatic masses detected at abdominal imaging     (ultrasound, CT-scan or MRI).      In the treatment arm, RTE assessment of pancreatic masses will be performed using a last     generation ultrasound machine, and all suspicious areas at elastography (i.e. those appearing     in dark blue color as a consequence of higher cellularity of tumoral tissue) will be recorded     and stored in our database. A 25 G needle will be then inserted into the most suspicious part     (dark blue) of the lesion and immediately after the procedure the stylet will be removed.     At the end of the procedure, the needle will be retracted and the samples, after being     checked for adequacy by an on-site cytotechnician, will be prepared for cytological     examination.      Primary endpoint will be diagnostic yield of the procedure. Secondary endpoints the     diagnostic sensitivity, specificity, number of passes needed to achieve an adequate sample     and safety It will be planned to enroll 280 patients (140 per arms) within 1 year. A minimum     follow up of 12 months from the last patient unsuitable to surgery will be required.   "
5727|NCT03210935|"     Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and     cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown     in terms of natural behavior, prognosis, treatment and outcomes.      CARADERM is a French prospective national cohort enrolling patients with either one of these     3 tumor types, whose objectives are :        -  to provide epidemiological, clinical and socio-economic characteristics of patients        -  to identify new clinical or epidemiological prognostic factors for these rare cancers        -  to evaluate the impact of various treatments on outcomes   "
5728|NCT03210922|"     Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the     elective cervical spinal surgical patients: a study of clinical predictors and outcomes   "
5729|NCT03210909|"     An intravenous infusion in healthy subjects to obtain information about the absorption,     metabolism, and excretion (AME) of BMS-986231   "
5730|NCT03210896|"     Breath analysis is becoming of increasing interest to researchers throughout the world for     disease identification and monitoring. It is known that small chemicals dissolved in the     blood can pass through the blood/air barrier within the lungs and be exhaled in normal     breath, with many of these chemicals being potential biomarkers for a broad range of     diseases. These specific biomarkers need to be identified so that gas analysis instruments     and sensors can be designed to detect these chemicals.      The aim of this study is to determine if there are biomarkers in exhaled breath that     correlate with blood glucose concentration. This biomarker can then be used to produce a new     device that will allow diabetic patients to monitor their blood glucose levels in a quick and     non-invasive way. The investigators believe this will lead to a significant improvement in     the quality of life of those suffering from this condition.      In this study breath samples will be collected using three different methods to maximise the     chemical information available from each breath. Breath samples from Type 2 diabetic patients     will be compared with healthy controls. Subgroups will have repeated breath samples after     drinking orange juice or during normal day-to-day activities. This is to measure any changes     in breath chemicals over time. The chemicals detected will be compared with blood tests, to     identify potential breath biomarkers for blood glucose concentration, and to see if factors     such as sex, age, and diet have any effect on the biomarkers detected.      This is a single centre pilot study taking place at University Hospitals Coventry and     Warwickshire NHS Trust, and the analysis of the breath samples will be carried out at the     University of Warwick. This study is funded by Boydsense, a US company whose mission is to     change how chronic conditions are detected and monitored, through breath analysis.   "
5731|NCT03210883|"     This retrospective multicenter cohort will validate an independent association of     electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained     ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients     with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for     prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in     systolic heart failure patients with primary prevention ICD.   "
5732|NCT03210870|"     Purpose of this study is to learn more about how nutritional advice given during pregnancy     affects a mother's food choices and her baby's growth.   "
27686|NCT02923336|"     The purpose of this study is to evaluate the influence of non betablockers in     gastrointestinal motility (transit time) in patients with liver cirrhosis.   "
5734|NCT03210844|"     Background The direct anterior approach (DAA) and micro-posterior approach (micro-PA) for     total hip arthroplasty (THA) become popular approaches due to their fast recovery and good     clinical outcomes. However, little is known if DAA is superior to micro-PA in implant     positioning and functional outcomes for THA patients.      Methods The investigators conducted a non-randomized comparative study to compare component     positioning and clinical outcomes of the consecutive unilateral primary THA patients operated     with DAA techniques and that of those operated with micro-PA techniques by a single surgeon.     The investigators used DAA techniques with standard operation table and micro-PA techniques     featuring indirect-contracture-releasing capsulotomy, preservation of short external rotators     except piriformis and conjoint tendon, and tendon-to-bone capsulotendinous repair. The     investigators used propensity-score matching analysis to compare the postoperative THA     component positioning and clinical outcomes in DAA and micro-PA groups.   "
5735|NCT03210831|"     The goal of this project is to identify neonates who are predisposed to Necrotizing     Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive     measures as well as biochemical markers to identify neonates early in the disease process.     Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to     institute or test treatments in the long term to prevent the progression of the disease in     these infants.   "
5736|NCT03210818|"     Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and     respiratory support to patients with heart and respiratory failure. It can save time for     these patients to regain organ function or to receive transplantation. Both our team and Ince     et al. from the Netherland found that the microcirculatory dysfunction is more severe in ECMO     non-survivors. The next step of research is to find out the key factors that affect     microcirculation in ECMO patients. Because the blood flow supplied by the venoarterial ECMO     (VA-ECMO) is directly related to macrocirculation, this study aims to investigate the effect     of adjustment of VA-ECMO blood flow on microcirculation. We hope that the results of this     study can help the medical team to improve the quality of ECMO care. After evaluation,     explanation, and acquisition of agreement, the sublingual microcirculation will be examined     within 24 h and at 48 h after placement of VA-ECMO. The VA-ECMO blood flow will be recorded,     and the baseline microcirculation will be examined. After the ECMO technician adjusting the     ECMO flow, sublingual microcirculation will be examined 2 minutes after each adjustment, and     the change of ECMO blood flow will be recorded. When the ECMO team plans to weaning off the     ECMO within 72 h, the sublingual microcirculation will be examined. The VA-ECMO blood flow     will be reduced by ECMO technician, and sublingual microcirculation will be examined 2     minutes after each adjustment of the blood flow. The ECMO parameters, medications, and     clinical data will be recorded, and the prognosis will be followed up on the 28th day.   "
5737|NCT03210805|"     Investigate the in vivo effects of n-3 PUFA supplementation on inflammation, gene expression     and epigenetic signatures.      Ex vivo stimulation of peripheral blood mononuclear cells (PBMCs) collected pre and post n-3     supplementation and measurement of it's effect on inflammation, gene expression and     epigenetic signatures.   "
5738|NCT03210792|"     A pilot study for a prospective randomized clinical trial was conducted to compare subjects     using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the     intervention.      The primary outcome was difference in the level of pain based on the visual analogue scale     (VAS) between before and after intervention in each group during forceful and resting     respiration.      VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis   "
5739|NCT03210779|"     This research will study the healing of standardized wounds created in the oral mucosa of     volunteer participants during daily intake of tablets and topical application of oil     containing the probiotic bacterium Lactobacillus reuteri. Our null hypothesis is that the     consumption and topical application of probiotic supplements containing L. reuteri does not     improve clinical healing of oral wounds in healthy participants when compared to controls.   "
5740|NCT03210766|"     The aim of this study is to evaluate the efficacy of oral administration of nabilone or     THC/CBD administration in combination with spinal cord stimulation (SCS) in FBSS patients     refractory to other available therapeutic strategies.   "
5741|NCT03210753|"     Background and objective      The introduction of a proteasome inhibitor bortezomib has significantly improved response     rates and overall survival in patients with multiple myeloma (MM), and it has soon become the     cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However,     the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which     becomes an obstacle during treatment with bortezomib, either alone or in combination. Until     now, there are no consistent findings regarding the risk factors that may cause BiPN. There     is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk     factors of BiPN using retrospective analysis in a large cohort with longer observation period     as well as the relations between BiPN and gene polymorphisms, and to compare different routes     in the incidence of BiPN.      Methods      This is a retrospective cohort study with a sample size of about 400 MM patients treated ever     with at least one full cycle of bortezomib in the institution. All the patients enrolled need     to be adults (≧20 years ) with measurable M-component in either blood or urine. The     investigators will perform a retrospective chart review to collect clinical data, including     anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this     cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also     plan to perform genotyping for the possible genetic factors associated with development of     BiPN.      Expected contributions      The successful collaboration between clinical hematologist-oncologist and biopharmaceutical     researcher would result in the concrete evidence of efficacy and safety of bortezomib in     Taiwanese patients with MM. The findings in this large cohort study will unveil the risk     factors of BiPN, including the administration routes and ethnicity. As results, the     investigators would be able to provide the precision medicine-based bortezomib treatment     strategy to MM patients in Taiwan.   "
5742|NCT03210740|"     To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the     treatment of Actinic Keratosis (AK) Lesions   "
5743|NCT03210727|"     The investigators will use a single arm design and deliver a new supportive intervention     entitled, Ready to Connect, Actively Relax and Exercise (CARE). The purpose of the study is     to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE     intervention. Effectiveness outcomes include caregiver self-efficacy, distress, and coping     style, and patient quality of life, symptom burden, and healthcare utilization.   "
5744|NCT03210714|"     This phase II trial studies how well pan-FGFR tyrosine kinase inhibitor JNJ-42756493 works in     treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have     spread to other places in the body and have come back or do not respond to treatment with     FGFR mutations. Pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth.   "
5745|NCT03210701|"     An estimated 21% of Canadians with HIV are unaware of their infection. There is a need to     improve access to HIV testing to detect infections earlier so individuals can access care     early and take steps to prevent transmission to others. Barriers to HIV testing include     limited access or reluctance to go to traditional testing sites (doctor's offices and     sexually transmitted infection clinics), and the lengthy wait time to receive test results     from standard laboratory-based HIV testing (usually 1-2 weeks). These deterrents are     particularly significant for those at highest risk of infection, who may be socially     marginalized or stigmatized. In rural areas, HIV testing may only be available through     doctor's offices and hospitals, yet many Canadians do not have access to a family physician.     Pharmacists are among the most trusted and accessible healthcare providers, and are well     positioned to improve access to HIV testing. Point of care tests for HIV are easy to     administer and results are available within minutes, making them ideal for use in the     community pharmacy setting. Point of care testing (POCT) by pharmacists can ensure     individuals receive their test results, and facilitate timely linkages to care and treatment.     This adaptation grant will look at factors influencing the acceptability and feasibility of     pharmacist-provided rapid POCT for HIV in two Canadian provinces, including pharmacies in     both urban and rural areas. The effectiveness of pharmacist-delivered POCT will be considered     from a variety of perspectives including people living with or at risk of HIV, as well as     pharmacists as the service providers.   "
5746|NCT03210688|"     Traditionally MCN is treated with a high dose of prednisolone, which induces remission in     60-90% of patients. Prednisolone treatment contains numerous side effects and the current     dose is empiric. Given the lack of efficacy evidence and the risk associated with the     currently accepted treatment regimen there is a need to characterize the outcome in MCN     further, and to establish new, and potentially less toxic treatment regimens.      The aim is to examine if treatment with reduced dose of prednisolone in combination with     activated vitamin D is as effective as standard high dose prednisolone in achieving remission     and preventing relapse in MCN, and if reduced dose prednisolone is associated with fewer side     effects compared to standard dose. Furthermore, the study will examine the influence of     prednisolone metabolism on the efficacy and side effects of prednisolone in the treatment of     MCN.   "
5747|NCT03210675|"     Interventional, comparative, open label, single-center study to demonstrate that an early     (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea     (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of     life is associated with an improved neurocognitive development at the age of 3 years.   "
5748|NCT03210662|"     The goal of this clinical research study is to learn if the combination of external beam     radiation therapy (EBRT) and pembrolizumab can help control relapsed (has come back) and     refractory (has not responded to treatment) non-Hodgkin's Lymphoma (NHL). The safety of this     combination will also be studied.   "
5749|NCT03210649|"     The purpose of this study is to investigate the safety/tolerability and     pharmacokinetics/pharmacodynamics of CKD-519   "
5760|NCT03210506|"     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral     replication. In hepatitis B infection, cytokines played a vital role. This study was aimed at     investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue)     therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in     the secretion of cytokines.   "
5750|NCT03210636|"     In order to help the surgeons to clearly visualize their target operating area and create an     optimal operative field throughout the procedure, the device owners have developed a new     class of inflatable laparoscopic retractors for both bowel and organ specific retraction with     load bearing bore by an inflatable reinforced material that is atraumatic, biocompatible, and     are self-retained, i.e. require no personnel to maintain them post-placement.      Specifically, the device owners menu of designs hold a range of 50 - 100 % of the bowels and     support at minimum 6 lbs in the vertical direction. All the device owners devices enter the     abdominal cavity through a conventional 10mm incision. The pressure within the inflatable     tubes of the device will not be above 15 mmHg, which is the current pressure used to     insufflate the patient's abdomen with carbon dioxide (CO2). The devices are able to retract     up to 10 cm of the bowels in any direction within the coronal plane and retract the bowels     10cm upward, towards the abdominal wall. Finally, the invention here-in described can be     manipulated easily to provide retraction of specific organs, including, liver, bladder,     uterus, etc.      The device has been approved by the FDA for clinical use (FDA Registered) and the purpose of     this study is to evaluate the device in laparoscopic operations for safety and feasibility.   "
5751|NCT03210623|"     The study is a prospective, multi-center, stratified randomized, single-blind, parallel     assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either     stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims     to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as     compared to Solitaire™.   "
5752|NCT03210610|"     in this study the investigators will measure the colchicine trough levels in 80 FMF patients     taking stable doses of colchicine   "
5753|NCT03210597|"     The objective of the present study was to compare the neuromuscular, cardiorespiratory and     metabolic effects of 12 weeks of aerobic training, strength training and combined training in     the aquatic environment in women with MS. For this purpose, 51 postmenopausal, sedentary and     MS women were randomly divided into three intervention groups: hydro-aerobic (HA, n = 18,     63.77 ± 5.03 years), hydro-power (HF, n = 16, 61.01 ± 4.93 years) and hydro-combined (HC; n =     17; 60.52 ± 6.91). A subsample participated in eight weeks without physical exercise to     characterize a control period. The three intervention groups performed two weekly sessions of     60 minutes for 12 weeks. Before and after the training period, blood tests, muscle strength     tests, cardiorespiratory evaluation, functional tests and a questionnaire were performed. For     statistical analysis, the Generalized Estimates Equations (GEE) model was used, using the     group and the time as factors. The Bonferroni post hoc was used to locate the differences     and the significance index adopted was α = 0.05.   "
5754|NCT03210584|"     Evaluation and comparison of histological analysis, 9,4 tesla MRI, Full-Field Optical     Coherence Tomography (FFOCT) and ultrasound-based navigation system for cartilage     degeneration analysis of patellofemoral joint.   "
5778|NCT03210272|"     The primary objective of this trial is to investigate the safety and tolerability of BI     1358894 in healthy male subjects following oral administration of single rising doses.     Secondary objectives are the exploration of the pharmacokinetics (PK), including dose     proportionality of BI 1358894 after single dosing.   "
27955|NCT02919826|"     To determine the feasibility and effectiveness of a RCT of an adapted DBT group delivered to     individuals with ID and emotional dysregulation.   "
5756|NCT03210558|"     Trial objectives and purpose: The primary aim is to study the effects of moderately increased     testosterone concentration on aerobic performance (endurance time to exhaustion), and     secondary aims to investigate the effects on submaximal work on treadmill, muscle strength,     body composition, behaviour and well-being, blood parameters, steroid hormone profile,     gynecological parameters and skeletal muscle parameters in young healthy women in a     double-blind, randomized, placebo-controlled trial.      Treatment: Ten weeks of transdermal treatment with testosterone cream 10 mg daily or placebo     cream in a randomized design (1:1).      Primary outcome: Aerobic performance (endurance time to exhaustion)      Secondary outcomes:        1. Submaximal work on treadmill (oxygen uptake, ventilation, heart rate, blood lactate and          subjective rate of exhaustion)        2. Muscle strength (Cybex apparatus, force transducer, counter movement jump)        3. Body composition (Dual X-ray Absorptiometry: muscle mass, fat mass, bone mass)        4. Behaviour and well-being (Quality of life, Profile of mood state, Confidence          Questionnaire, Aggression Questionnaire)        5. Blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP)        6. Steroid hormone profile in blood and urine        7. Gynecological evaluation (ovarian and endometrial variables on ultrasound)        8. Skeletal muscle morphology, metabolic enzymes and muscle protein synthesis      Study population: Fifty healthy menstruating women will be included in the study and     randomized to treatment with testosterone or placebo. Inclusion criteria: 18-35 yrs of age;     body mass index (BMI) 19-25; non-smoking; a moderate to high self-reported level of     recreational physical activity; not taking hormonal contraception and willing to use highly     efficient non-hormonal contraception during the study (intrauterine device, bilateral tubal     occlusion, vasectomised partner, same-sex partner, or sexual abstinence); accepting to not     participate in any sports competitive event during the study period plus one month. Exclusion     criteria: the presence of cardiovascular, liver, biliary or renal disease; hyperlipidemia;     uncontrolled high blood pressure; endocrinological disorder; oligomenorrhea (menstrual     intervals of more than 6 weeks) or amenorrhea (no menstruation for at least 3 months);     pregnancy; a history of thromboembolic disorder; any malignancy; and intake of hormonal     contraception the last two months prior to the study.   "
5757|NCT03210545|"     DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel     biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with     Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement     therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be     replaced with dexamethasone in physiological and supra physiological doses. Blood, saliva,     urine, health related Quality-of-life self-assessment forms, measurements of physical     activity and sleep quality will be collected from both treatment periods.   "
5758|NCT03210532|"     A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate     the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or     DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia   "
5759|NCT03210519|"     This is a randomized, double-blind, placebo-controlled, parallel comparison trial to evaluate     the efficacy and safety of Eleutherococcus Senticosus taken orally by patients under regular     dialysis. Eligible subjects with written consent were randomized into one of the two groups:     A. Acanthopanax senticosus (30mg/vial); B. Placebo. After 2-4 weeks of run-in period, the     study subjects were asked to take the investigational products orally for 90 days in order to     evaluate the effects of oral Eleutherococcus Senticosus liquid on the markers of     inflammation, anemia, and safety, and to compare the efficacy among oral Acanthopanax     senticosus and placebo.   "
6906|NCT03195478|"     A Study to Evaluate Safety and Effectiveness of Nivolumab in Combination With Ipilimumab in     Chinese Patients With Previously Treated Late-Stage Cancer   "
5761|NCT03210493|"     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral     replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role     in immune. This study was aimed at investigating the changes of Treg cells frequency and     function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside     analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed     the virus, which led to the decline of Treg cells frequency and function;negative regulation     of Tregs for immune cells diminished, hence, the function of immune cells recovered.   "
5762|NCT03210480|"     The aim of the study is to assess the tolerability, efficacy and safety of a new lithium     sulphate prolonged release formulation (Lithiofor®) in patients affected by Bipolar Disorder     poor tolerant to lithium immediate-release treatment in terms of lithium-induced tremor when     switched from therapy with a lithium carbonate immediate release formulation (Carbolithium®)     to a new lithium sulphate prolonged release formulation (Lithiofor®).   "
5763|NCT03210467|"     Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play     an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral     replication. In hepatitis B infection, Plasmacytoid Dendritic Cells（pDCs） are the main     effector cells in early antiviral innate immune response. This study was aimed at     investigating the changes of pDCs frequency and function, and the expression of costimulatory     molecules CD86(Cluster of Differentiation antigen 86) during Peg-IFN-αand entecavir(ETV)     therapy.Meanwhile, investigators want to verify whether Peg-IFN-α suppressed the virus and     the reduction of virus led to the recovery of pDCs function, or Peg-IFN-α enhanced pDCs     function which gave rise to the decline of the virus.   "
5764|NCT03210454|"     The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to     measure the impact of increasing women´s incomes and providing gender equality trainings on     women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project     will be the first in Latin America to evaluate rigorously the impact of a marketing     intervention, alone and combined with IPV prevention training. The knowledge generated from     this evaluation has the potential to identify the most effective solutions to empower women,     as well as to drive transformative change in current approaches to reduce IPV and promote     gender equality in highly vulnerable populations in Colombia, and worldwide.   "
5779|NCT03210259|"     The primary objective of the trial is to assess the PK similarity between patients receiving     Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with     moderate-to-severe chronic plaque psoriasis.      The secondary objectives of this trial are to descriptively compare the safety,     immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those     who alternate between BI 695501 and Humira®.   "
5780|NCT03210246|"     This study will be performed as a multi-center, randomized, double-blind study in 60 healthy     women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a     COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor     modulator (PRM) vilaprisan.   "
5765|NCT03210441|"     In post-menopause women affected by breast cancer and treated with chemotherapy, overweight     and obesity are considered both a risk factors as well as a negative prognostic factors since     they increase the risk of early relapse and death. Furthermore, a decrease in weight may also     occur during chemotherapy and is associated to a reduced quality of life and survival. Also,     the majority of patients under chemotherapy refer dysgeusia, an alteration in taste that can     determine food aversion, selection of hypercaloric food or reduced food introduction up to     malnutrition. Our aim is to evaluate eating habits changes in patients affected by breast     cancer and under chemotherapy treatment and to better understand how this alterations     influence the quality of life, anxiety, depression and insomnia of patients as well as     overall survival.   "
5766|NCT03210428|"     Hypoxic tumour cells within the primary tumour have shown prognostic importance for local and     metastatic disease control in several cancer sites. Radioresistant hypoxic cells diminish the     rate of local control, and the hypoxia driven increase in metastatic potential of the tumour     and lowers the rate of distant disease control. DCE MR imaging has been used to quantify the     extent of poor perfusion regions within cervical tumours and it has been shown to be a     surrogate of hypoxia. Furthermore, a number of studies have demonstrated that DCE MR is     predictive of disease failure in cervix cancer.      The EMBRACE II study will implement an imaging sub-study, which will evaluate the value of     quantitative MR imaging to identify patients at increased risk of disease recurrence (local,     nodal and systemic).   "
5767|NCT03210415|"     In China, there's no effective prevention and treatment on preterm birth for pregnant women     ≥35 years old, so this study is necessary.   "
5768|NCT03210402|"     New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with     approved indications for pacing to determine if elevated pacing therapy is tolerated and     whether there is a signal for efficacy.   "
5769|NCT03210389|"     The purpose of this study is to evaluate the efficacy and safety of chemotherapy with     Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.   "
5770|NCT03210376|"     Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the     abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a     common complaint from patients who have had abdominal surgery and the pain is thought to be     related to the use of IP.      In addition to anesthesia (which keeps participant asleep during surgery), the current     standard practice is to block the nerve-muscle junction with a type of drug called     neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower     level of insufflation pressure is needed by the surgeon.      To reverse the effects of NMB after surgery, a drug called neostigmine is given.      The goal of this clinical research study is to compare the use of standard-of-care moderate     NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly     patients (patients who are 65 years of age or older) who are scheduled to have robotic     abdominal surgery. Deep and moderate in this study refers to the dose or strength of the     NMB given.   "
5810|NCT03209856|"     The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through     vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the     success of IVF cycles.   "
5771|NCT03210363|"     Dengue is an important public health problem despite the efforts of local health authorities     to mitigate the impact of epidemics and the epidemiology of dengue evolved from an     endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of     chikungunya virus in the Americas was identified in Caribbean countries and territories     including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had     reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert     regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in     South America led to a rapid spread throughout South and Central America, reaching French     Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and     the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus     have become social, political, and public health challenges that require specific and     non-available immune status information.   "
5772|NCT03210350|"     It had been shown that high percentage of severe preeclampsia patients got a high cerebral     perfusion pressure (CPP) due to abnormal autoregulation of cerebral blood vessels with     associated endothelial dysfunction and disrupted blood brain barrier. Moreover, patients with     high CPP is more likely to present with headache compared to other patients with normal     CPP.In this particular scenario, use of magnesium sulphate is associated with marked     reduction of CPP and. hence prevention of cerebral damage.This hypothesis was confirmed by     new magnetic resonance techniques that demonstrated brain edema in eclampsia/ severe     preeclampsia patient mostly due to vasogenic edema and less commonly attributed to cytotoxic     edema.      Changes in the optic nerve sheath diameter (ONSD) mirrors the changes in the Intracranial     pressure(ICP), subsequently when the intracranial pressure increases the optic nerve sheath     diameter (ONDS) also increases.      The aim of this study is to determine the effect Magnesium sulphate infusion on intracranial     pressure, in patients presented with severe preeclampsia by measuring changes in the ONSD     using ultrasound examination.   "
5773|NCT03210337|"     The primary objective of this study is to evaluate the effectiveness of A-101 compared to     vehicle when applied to 1 common target wart on the trunk or extremities.   "
5774|NCT03210324|"     To investigate the efficacy and adverse effects of mifepristone tablets in widely used     conditions, to evaluate the relationship between interests and risks used in general or     special populations, to further observe the safety and efficacy of drugs.   "
5775|NCT03210311|"     Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Early diagnosis and     treatment is very important to alter the normal progression of this disease. A threshold (>=     3% volume change) that recognizes subclinical lymphedema is promoted. When the lymphedema is     diagnosed late, options for treatment are diminished as fibrous tissue is formed.      Preoperative investigation with near-infrared fluorescence lymphography can show an     abnormality. Even if a linear transport is visualized, velocity of the transport can be     diminished or a different pathway than normal can be visualized. Such an extensive evaluation     has not been performed yet.      This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically     visible (subclinical). The investigators hypothesize that the evolution of lymphedema can be     altered if treatment is started in the subclinical phase.   "
8339|NCT03176745|"     The investigators aim to determine the optimal number of measurements required for     multiple-breath-washout derived lung function parameters in adults with pulmonary disease as     well as in healthy controls   "
5781|NCT03210233|"     Teicoplanin is an antibiotic used very commonly to prevent infection during surgery. Its use     has expanded rapidly in the last few years, with around 18,500 doses administered in Leeds     Teaching Hospitals NHS Trust alone, in 2014-15. Unfortunately, anaphylaxis (a severe allergic     reaction) to the drug appears to be increasing. These reactions can result in admission to     intensive care, prolong hospital stay, or even be fatal.      It is vital that patients who suffer anaphylaxis have tests to accurately identify the cause,     so they can avoid the drug in future. However these tests are currently very limited, because     we don't have any diagnostic tools proven to confirm or refute a diagnosis of teicoplanin     allergy. We have to make a 'best guess' diagnosis, leaving patients vulnerable to harm in the     future, should they require antibiotics again. We need to reliably diagnose teicoplanin     allergy to reduce this arm. Where a diagnosis of teicoplanin allergy is confirmed, patients     and their doctors know to avoid it. Importantly, where allergy is excluded, teicoplanin can     be safely used, avoiding alternatives that may be less effective, more toxic, and more     expensive. This directly benefits individuals, saves the NHS money by reducing avoidable     harm, and helps improve antibiotic stewardship at a population level - which in the long term     helps reduce antibiotic resistance. The clinical need for this work has become imperative.      Collaborating with our industry partner ThermoFisher (significant expertise in this area), we     aim to:        1. Standardise the current skin testing protocols being used when testing patients with          suspected teicoplanin allergy.        2. Develop laboratory tests to support the skin tests, and give a more confident diagnosis          to patients.        3. Understand how and why people develop allergy to teicoplanin, to better predict and          modify the allergic response.   "
5783|NCT03210207|"     Between January and December 2012, a total of 40 patients underwent GLP. The study will     assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60     months.   "
5785|NCT03210181|"     Myofascial pain is an important cause of neck pain or neck and shoulder pain. Neck shoulder     pain is a common socioeconomic problem that negatively affects the quality of life. Different     treatment strategies with limited effectiveness or application have been implemented.     However, medication remains a widely used approach.      The levator scapulae is one of the muscles involved in myofascial pain leading to levator     scapulae syndrome. The muscle limits the rotation of the neck. It is innervated by branches     of the third and fourth cervical nerves through the cervical plexus. Hence, performing     superficial cervical plexus block may have some potential effect in reducing myofascial pain.   "
5786|NCT03210168|"     This study evaluates the safety, tolerability, and activity of BioFe in the dietary     management of iron deficiency in adults.   "
5788|NCT03210142|"     The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve     Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause     contraction of the genioglossus muscle, which will move the tongue forward, opening the     upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea     (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that     require an open surgical approach to wrap a cuff electrode around the HGN.   "
5842|NCT03209440|"     Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer.     The study team will use a spiritual intervention, Dignity Therapy (DT), to help these     patients maintain pride, find spiritual comfort, enhance continuity of self, and ultimately     make meaning of their life threatening illness.   "
5789|NCT03210129|"     Physical activity is not only efficient for primary prevention of several cancer types, but     it also plays an important role in cancer survivors. Physical activity after a cancer     diagnosis has been associated with reduced overall and cancer-specific mortality. It has     significant positive effects on physical fitness and several cancer-related symptoms     including fatigue, sleep disturbance, depression and anxiety. The evidence is considerable     and consistent for breast, colorectal and endometrial cancers. However, patients are     generally insufficiently active, and participation rates in physical activity opportunities     offered by specialized organizations are low. This pilot study will evaluate the feasibility,     efficacy and cost-effectiveness of an intervention seeking to increase active lifestyle and     physical activity participation of cancer patients. To encourage this behavioural change,     motivational interviewing will be used, a patient-centred approach aimed at increasing the     patients' motivation for a behavioural change through open-ended discussions.      Seventy patients with breast, colorectal or endometrial cancer will be recruited within a     time period of 12 months. Patients will be randomly assigned to an intervention or a control     group. The intervention group will receive standard care alongside 12 motivational     interviewing sessions within 12 weeks. The control group will receive standard care only.     Physical activity behaviour (3D-accelerometer) and physical fitness (cardiovascular and     strength fitness) will be measured in the week preceding and following the intervention.     Additionally, a subgroup from both study arms will be assessed 12 weeks after the completion     of the intervention. The investigators hypothesize that sedentary time will decrease and time     spent in moderate and vigorous physical activity, physical fitness and quality of life of     cancer survivors will increase to a greater extent in the intervention group than in the     control group. Furthermore, health-related quality of life and resource use (intervention and     healthcare costs, out of pocket costs) will be measured to evaluate the cost-effectiveness of     the intervention.   "
5823|NCT03209687|"     The aim of this study is to test the hypothesis that addition of daily small dose of human     menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility     outcome in women undergoing in-vitro fertilization   "
5790|NCT03210116|"     A quality improvement project compares automatic palliative care consultation compared to     standard of care in the medical intensive care unit (ICU). The study will assess if the     intervention leads to an increased proportion of clearly delineated goals of care and quality     of life and examine if this intervention leads to decreased length of days in the ICU,     Hospital, and on mechanical ventilation.   "
5791|NCT03210103|"     The goal of this randomized treatment de-escalation study is to formally compare outcomes in     HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary     surgical approach, to provide a high level of evidence to guide the selection of treatment     options for a subsequent phase III trial   "
5792|NCT03210090|"     Donor and recipient CMV-serostatus is one of the risk factor for CMV infection in solid organ     transplantation. Recipients with IgG positive anti-CMV are classified as low-risk patients     since it is considered that patients also have specific cellular immunity against CMV.     However, investigators group has published that around 25% of solid organ transplant     candidates lack CMV-specific CD8+ T-cell response (humoral/cellular mismatch) and they are     at a higher risk of CMV replication after transplantation. The main goal of this study is to     analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell     transplantation (HSCT) CMV-seropositive donors on the CMV reactivation after HSCT in     CMVseropositive recipients. Investigators will study not only the incidence of CMV     reactivation but also the severity (duration and peak viral load), CMV disease and survival.     CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related     donors will be consecutively recruited from Reina Sofía Hospital (Córdoba) and Marqués de     Valdecilla Hospital (Santander).      Patients will be monitored during 12 months after HSCT. CMV-specific CD8+ T-cell response     will be determined in their donors, using QuantiFERON-CMV assay, to know the frequency of     humoral/cellular mismatch. Innate and adaptive immune reconstitution will be assessed by flow     cytometry and experimental QuantiFERON Monitor assay. CMV-specific CD8+ T-cell reconstitution     will be determined using QuantiFERON-CMV assay.   "
5793|NCT03210077|"     The critically ill patient is one of the most complex cases with regard to the optimization     of the anesthesia, as well as postoperative management. One of the most important steps in     the complex management of such patients is the modulation of anesthesia for every patient     needs. We start with the assumptions that the optimization of anesthesia should depend on     each patient, being conducted in an individual manner. We also believe that by     individualizing the anesthesia by monitoring the entropy it is possible to obtain an     appropriate management regarding hemodynamic complications during anesthesia including     tachycardia, bradycardia, hypotension and hypertension.   "
5794|NCT03210064|"     This study makes an observation over the objective response rate of Apatinib and 5-Fu     combination regimen in the three-line treatment of metastatic colorectal cancer. All the     participants will randomly receive the treatment of Apatinib and 5-Fu combination regimen or     5-Fu.   "
5795|NCT03210051|"     Currently, early reperfusion is considered as the most effective therapy for the treatment of     acute ischemic stroke (AIS). Over the past 20 years, intravenous tissue plasminogen activator     (IV tPA) has been demonstrated to be the only effective therapy for AIS. More recently,     several large randomized clinical trials have concluded the superiority of endovascular     mechanical thrombectomy for AIS. Furthermore, with the development of materials and     techniques, the occluded artery can be recanalized with high percentage (60%-90%), and the     rate of recanalization is still being improved. A great number of AIS patients are now     eligible for revascularization therapy and there should be a good prognosis of AIS after     recanalizing the occluded artery using mechanical thrombectomy. However, things are never as     simple as wished to be. The rate of patients with functional independence is less than 50%     and over 15% patients died at 3 months post thrombectomy. The discrepancy between the     functional outcome and recanalization rates encourage researchers to explore strategies that     further improving the functional outcome of AIS patients.      Remote ischemic conditioning has been demonstrated to reduce cerebral infarct size in mouse     model of focal cerebral ischemia. And clinical researches demonstrated the protective effects     of remote ischemic conditioning in AIS patient treated with IV tPA,. However, whether remote     ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic     stroke and undergoing endovascular treatment is still unknown.   "
5796|NCT03210038|"     Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in     order to undergo a cystoscopy examination will be recruited.      Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible     and rigid) and by use of anesthesia to the introitus.      Pain levels will be recorded prior to the examination, during entrance of the cystoscope in     the urethral meatus, immediately after the examination and 15 minutes after conclusion.   "
5843|NCT03209427|"     Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but     the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among     these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected     morphine.   "
5797|NCT03210025|"     The objective of the study is to compare the bioavailability of a generic product of     methyldopa with that of a reference product when administered to healthy volunteers under     fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917)     manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical     Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620).     The bioequivalence or bioinequivalence of the test and reference formulations will be     assessed and concluded based on the plasma pharmacokinetic data of Methyldopa, as well as WHO     guidelines on registration requirements to establish interchangeability.   "
5798|NCT03210012|"     This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater     diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And     68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).   "
5799|NCT03209999|"     Using cross-sectional samples from over 40 Demographic and Health Surveys, the investigators     studied the association between maternal employment and 3 indicators of Infant and Young     Child Feeding (IYCF): exclusive breastfeeding (EBF) among children less than 6 months old     (N=39,791) and minimum diet diversity (MDD) and minimum meal frequency (MMF) (N=137,208)     among children 6 to 23 months old. Mothers were categorized as formally employed, informally     employed, or non-employed. The investigators first used adjusted logistic regression models     to assess the associations within each country. The investigators then used meta-analysis to     pool associations across all countries and by region.   "
31071|NCT02879045|"     The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of     striae gravidarum: A randomized controlled clinical trial.   "
5800|NCT03209986|"     There has been great interest in recent years to take advantage of stem cells to treat liver     cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver     diseases in some studies. Randomization controlled studies are needed to confirm the long     term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety     and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.      This study is an open-label multicenter randomized control study. Patients with with     decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard     medical care(treatment）or standard medical care (control). Three times of MSC infusion     (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group     (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and     scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and     survival.   "
5801|NCT03209973|"     The study is to evaluate the efficacy of BGB-A317 assessed by Independent Review Committee     (IRC) in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured     by Overall Response Rate (ORR) per the Lugano Classification   "
5802|NCT03209960|"     The purpose of this study is to improve spasticity diagnosis through development of a simple     physical examination guide for primary care providers to identify patients who would benefit     from being referred to a movement disorders neurologist for a spasticity evaluation.   "
5803|NCT03209947|"     There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the     elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a     population of asymptomatic subjects   "
5804|NCT03209934|"     The choice of antimicrobial therapy to treat complex bone and joint infections (BJI) is     challenging, requiring consideration of: (i) the problem of bone diffusion; (ii) the     necessity of using antimicrobials active against bacterial biofilms; (iii) the growing     incidence of antibiotic resistance; and (iv) the high risk of severe adverse events (SAE) in     response to first-line antimicrobials in these patients.      Consequently, off-label use of recently developed antimicrobials, such as daptomycin, is     frequently required as salvage therapy in complex BJI. Even if daptomycin does not have     approval for the treatment of BJI, the Infectious Diseases Society of America guidelines     propose this antibiotic as alternative therapy for prosthetic joint infection. The     recommended dose is 6 mg/kg/d, whereas recent data support the use of higher doses in these     patients as bone penetration of daptomycin is limited.      The present cohort study aimed to assess the safety and efficacy of prolonged high-dose (>6     mg/kg/d) daptomycin salvage therapy in patients with complex BJI.   "
5805|NCT03209921|"     Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic     option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus     species in the latest Infectious Diseases Society of America (IDSA) guidelines.      The population pharmacokinetics (PK) of daptomycin have been described in various groups of     patients in previous publications. However, little information exists on the PK of daptomycin     in patients with bone and joint infections (BJI). Also, previous population studies did not     investigate daptomycin PK over prolonged therapy, and, to our knowledge, no study has     reported the intraindividual PK variability of this drug.      The aim of this study is to describe the inter- and intraindividual PK variability of this     drug.   "
5806|NCT03209908|"     Pregnant women carry high HBV DNA loads before delivery, which is the most important factor     leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment     during late pregnancy can significantly reduce the incidence of HBV MTCT, but security     problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim     of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF)     antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of     hepatitis B virus(HBV MTCT).   "
5807|NCT03209895|"     This study is designed to evaluate the effectiveness of a proprietary nutritional supplement     that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and     discomfort in participants, compared to an inert placebo (palm oil) control and to a positive     control (glucosamine-chondroitin). The purpose of the study is to determine if the     combination of KO, AX, and HA will benefit participants with joint pain.   "
5808|NCT03209882|"     This study evaluates the effects of transcranial infrared laser stimulation (TILS) on     prefrontal metabolism and hemodynamics in veterans with post-traumatic stress disorder     (PTSD). The subjects will receive six TILS interventions and one sham intervention in a     course of seven weeks.   "
5809|NCT03209869|"     Subjects with relapsed or refractory neuroblastoma will receive ex-vivo expanded and     activated natural killer (NK) cells from a haploidentical donor in conjunction with the     immunocytokine, hu14.18-IL2.   "
5811|NCT03209843|"     The objective of PERFECTO is to assess the reendothelialization at 3 months after     successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES)     by OFDI analysis. Designed as a multicentric, observational and prospective study which will     be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be     realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of     stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia     proliferation will be measured over the entire length of each stent implanted combining in a     composite primary endpoint.   "
5824|NCT03209674|"     The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery     aims to prospectively collect data in order to test the association between various     preoperative and per-operative variables ; and several postoperative outcomes such as     mortality, shock, redo surgery, sepsis and extracorporeal life-support.   "
5825|NCT03209661|"     Investigating the acute effects of a single use E-Cigarette upon vascular health.   "
5826|NCT03209648|"     Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential     to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of     CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.   "
5812|NCT03209830|"     Many people who have undergone subarachnoid hemorrhage from an aneurysm (an artery of a vein     in the brain) struggle with a pronounced fatigue as well as a number of other sequelae such     as impaired concentration, memory deficits and emotional problems. Exhaustion is often     permanent and can lead to a significant worsening of quality of life and be the cause of     disability. This condition does not only have major consequences for the individual who is     affected, but also for their families and for society. So far no effective treatment for     fatigue has been found. The drug OSU6162 has shown a beneficial effect on fatigue and other     impairments after stroke and after traumatic brain injury. There is good reason to believe     that OSU6162 can also improve fatigue and other impairments after aneurysm bleeding and thus     increase the chance of returning to the level of daily function they had before the bleeding.     The study is double blinded and measures the effect of OSU6162 and placebo on fatigue and     neuropsychological function.   "
5813|NCT03209817|"     This clinical trial aims to test the effects of consuming two types of tomato (one ordinary     cherry red tomato containing lycopene, and the other a yellow cherry tomato low in lycopene),     on cardiovascular risk factors including endothelial function as the primary outcome, and     blood lipids, inflammatory factors and blood pressure.      In a crossover design, participants of this study will randomly consume 300g of raw cherry     (red and yellow) tomatoes per day for four weeks, with a control period consuming no tomato     products. Before and after each intervention, the cardiovascular outcomes mentioned above     will be measured in the clinic.   "
5814|NCT03209804|"     To evaluate the clinical benefits and risks of hybrid operating techniques in management of     cerebral arteriovenous malformations.   "
5815|NCT03209791|"     In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to     degrade MAA adducts.   "
5816|NCT03209778|"     Patients with schizophrenia suffer from autobiographical memory disorders. Patients have     difficulty to remember vividly personal past events when they are specifically asked for.     Indeed, this task requires a good executive functioning to retrieve precise information     stored in long term memory. Interestingly, executive functioning has been showed impaired in     schizophrenia and studies showed that their autobiographical memory impairments were directed     related to their executive dysfunction.      Yet, in daily life people remember more often autobiographical memories spontaneously,     without trying voluntarily to recall them.      In that case, the involuntary recall of personal past events is much less sustained by     executive functioning.      In this protocol the investigators would like to investigate and compare subjective     characteristics of involuntary and voluntary autobiographical memories in order to highlight     the role of executive dysfunction in patients' autobiographical memory impairments.   "
5817|NCT03209765|"     It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)     worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong     Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based     on data from 2014.      Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for     average-risk asymptomatic individuals starting at age 50. Fecal immunochemical tests (FIT),     is one of the recommendation as first-line modality for CRC screening. Since yearly testing     is recommended to maintain programmatic effectiveness longitudinal adherence is a critical     component of FOBT-based screening programs. Our previous study conducted in Hong Kong showed     that the rate of compliance with CRC screening was declining since the first year of     enrolment8.      In recent years, social media (SM) has become an increasingly popular source of health     information. By providing an easily accessible and interactive channel of communication     between reviewers and information providers, it has potential values for affecting public     health. However, the effects of SM on the compliance of CRC screening by FIT has not yet been     studied.      WhatsApp Messenger, is the most popular social media messaging app worldwide. This randomized     controlled study will investigate the effect of WhatsApp vs no reminder on the compliance of     CRC screening by FIT.   "
5818|NCT03209752|"     In this study, the accuracy of a new numerical method is evaluated for predicting the 3D     effect of brace on idiopathic scoliosis. This method results from the combination of several     innovative technologies: the EOS imaging system and the anatomical transfer developed by     Anatoscope. This is an essential step in validating a digital tool that can be used in     routine clinical practice.   "
5861|NCT03209180|"     Assessment of clinical effect and treatment quality of immediate release carvedilol (IR)     versus slow release carvedilol (SR) in patients with HFrEF   "
5862|NCT03209167|"     The purpose of this study was to specifically compare the long term patient satisfaction of     the abdomen after DIEAP flap procedure with conventional abdominoplasty.   "
5863|NCT03209154|"     The aim of the study is to investigate and explore the most important aspects of     drug-adherence in the treatment of hypertension in order to improve treatment and blood     pressure control, implying that new knowledge will reduce morbidity and mortality.   "
12088|NCT03127605|"     Information relating to requesting compassionate access for this investigational drug can be     found at the following link:      http://www.pfizer.com/research/compassionate_use   "
5819|NCT03209739|"     It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)     worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong     Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based     on data from 2014.      CRC is one of the most preventable cancers because its development in general follows an     adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC. Recent     guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk     asymptomatic individuals starting at age 50. Modalities such as guaiac-based fecal occult     blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy (FS), and     colonoscopy are among the acceptable options for CRC screening.      While early detection and removal of colorectal adenoma by screening colonoscopy with     polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after     a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to     account for up to 10.5% of CRC. a CRC has been associated with proximal colon location, small     lesion, flat lesion, missed lesion, inadequate examination, incomplete resection of lesion,     tumor biology, and low adenoma detection rate (ADR). High ADR (eg, ≥ 20%) has been associated     with a reduced risk of interval CRC.      Bowel preparation includes diet restriction and proper use of laxative before the     colonoscopy, and this is one of the important factors to ensure a high quality colonoscopy.     Suboptimal bowel preparation may lead to decreased ADR, cecal intubation rate, and     surveillance interval and increased procedural time. Efforts to improve bowel cleansing     quality through traditional communication routines, including face-to-face verbal education,     written booklet or visual aids or telephone-based re-instruction have proven to be useful. A     recent study using WeChat, a widely used social media mobile app in China, has also shown to     be effectively improving bowel preparation level of a mixed population who received     diagnostic (77%), screening (15.8%) and surveillance (7.2%) colonoscopy. However, the impact     of social media mobile app on the bowel preparation level of screening colonoscopy is not yet     known. Hence, this study will investigate the effectiveness of the most popular social media     app worldwide, WhatsApp in bowel preparation level of screening colonoscopy.   "
5820|NCT03209726|"     The primary objective of this study is to develop an approach to determine eligibility for     subcutaneous ICD by analyzing routine clinical 12-lead electrocardiogram.   "
5821|NCT03209713|"     This study is a two-arm randomized controlled trial, implemented to assess the effectiveness     of a community-based educational program with and without a text messaging reminder system,     in increasing the rate of HPV vaccination completion among children of Mexican Americans.   "
5822|NCT03209700|"     This study is an extension to re-treat partial and non-responders from the previously     approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and     15-003200 (cryptoglandular perianal fistulas).   "
5828|NCT03209622|"     A randomized controlled trial was conducted in cardiology department and smoking cessation     center of University Hospital of Monastir (Tunisia). All smokers Hospitalized for ACS were     included. Participants were randomly assigned to either group A, initiating Nicotine     replacement therapy (NRT) in intra-hospitalization or a control group B that received NRT     after hospital discharge. The end point assessment was smoking abstinence at 24 weeks     following randomization, defined as self-reported abstinence in the past week before the 24     week clinic visit confirmed by a measured exhaled carbon monoxide ≤8 ppm. Data were analyzed     by intention to treat.   "
5829|NCT03209609|"     Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients     with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with     arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one     SVG bypass will be randomized to be supported by the VEST, while another will not be     supported and serve as control. Thus, the full cohort will provide a basis for comparison     between two sets of SVGs: A VEST supported set; and an unsupported set.   "
5830|NCT03209596|"     This study aimed to verify if orange juice supplementation can be a nutritional strategy to     ensure an adequate energy and micronutrients ingestion, influencing metabolic responses of     soccer players.   "
5831|NCT03209583|"     Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of     those affected having critical conditions requiring open heart surgery within one year of     birth. Surgical and medical advances have allowed many patients to live beyond their fourth     and fifth decades of life. Unfortunately, cardiac arrhythmias are a relatively common sequela     due to cardiac anomalies and surgical scars in addition to residual volume and pressure load     on the heart. Atrial arrhythmias, including sinus node dysfunction and intra-atrial     re-entrant tachycardia (IART) are among the more common abnormalities found in adults with     repaired CHD. The presence of IART significantly increases morbidity and mortality, and     anti-arrhythmic medications have been shown to be a sub-optimal treatment strategy with the     majority of patients requiring multi-drug therapy. Catheter ablation procedures remain a     treatment option, but are less successful for some patient demographics. In the mid-1990's,     pacemakers with atrial anti-tachycardia pacing (ATP) capabilities were developed, primarily     for the management of atrial flutter and fibrillation in adults with structurally normal     hearts. Given the need for pacemakers in the CHD population to manage sinus node dysfunction     and atrioventricular node conduction block, the adoption of atrial anti-tachycardia     pacemakers began to gain favor. However, there is limited data available comparing the safety     and effectiveness of ATP therapy between various demographics of CHD patients. In the current     study, the investigators aim to determine if ATP is an effective treatment strategy for IART,     specifically within particular sub-populations of CHD patients. Additionally, investigators     hope to delineate any significant differences in efficacy of ATP treatment between adult and     pediatric congenital heart patients. The research team will accomplish our goals with a     retrospective, multi-center study in which data is collected from existing electronic medical     records and pacemaker interrogations. Following data collection, the investigators will     employ statistical analyses to determine if certain CHD demographics are statistically     significant predictors of ATP therapy outcomes.      The purpose of this prospective/retrospective study is to determine how effective atrial     anti-tachycardia therapies are with the congenital heart patients who are known to have     atrial arrhythmias. As this population ages, we know that arrhythmic burden increases and     medications are increased or changed for symptomatic improvement.      Patients will be enrolled at the time of anti tachycardia device ATD placement or when device     therapies are turned on. Patients will need a minimum of 5 years of clinical history prior to     implantation and after implantation (unless patient is very young). Data will be collected     both retrospectively and prospectively. The research team will consent patients at the time     of clinical evaluations and scheduled follow-ups (usually 3 - 6 months). If therapy is     effective, investigators will determine the specific programming which was successful. If     therapy was ineffective, investigators will also determine if a change in programing was made     and if this improved ATP efficacy. Investigators will also determine the arrhythmia burden.     Cardioversion and medications before and after ATD implantation will be the key determinants     of arrhythmia burden in this study.   "
5832|NCT03209570|"     The purpose of this study is to prospectively compare a standard of care manual toileting     protocol (e.g., check and change strategy) to toileting patterns recorded by the TENA     Identifi system in identifying incontinence patterns and events, and, whether such data     differentially improve a care planning strategy, nursing effort, product use, and wet-time     for urinary incontinence.   "
5833|NCT03209557|"     Investigators will assess the feasibility of implementing a randomized control trial of a     behavioral intervention that uses smartwatch technology to monitor smoking behavior with     texts aimed at reducing smoking in pregnant women who smoke. Investigators will compare the     cessation rate of pregnant women who receive usual care through programs aimed at reducing     smoking with pregnant women who receive usual care and are using the SmokeBeat app with a     smartwatch.   "
5834|NCT03209544|"     The objective of the Think Life study is to test the effect of an online, unguided self-help     intervention, i.e. Think Life. The primary hypothesis is that Think Life will reduce suicidal     ideation. The secondary hypothesis is that Think Life will lead to improvements in depressive     symptoms, hopelessness, rumination, and anxiety. Positive changes are expected after     completing Think Life and at follow-up, twelve weeks after baseline.   "
5835|NCT03209531|"     The purpose of this study is to examine if thigh muscle weakness and the lack of muscle     activation that accompanies ACL injury can be improved through a form of mental coaching and     encouragement, known as operant conditioning.   "
5836|NCT03209518|"     The purpose of this study is to evaluate the safety in patients with premenopausal breast     cancer receiving the drug in the routine clinical setting.   "
5837|NCT03209505|"     This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with     contact lenses having difference coefficients of friction (CoF)   "
5838|NCT03209492|"     The purpose of this study is to evaluate the safety in patients with prostate cancer     receiving the drug in the routine clinical setting.   "
5839|NCT03209479|"     The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous     injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis     in the routine clinical setting.   "
5840|NCT03209466|"     There is controversy regarding the utility of antiseptics in wound management for diabetic     foot ulcer syndrome. The aim of this study is to assess chlorhexidine gluconate at 0.125% vs.     saline solution to reduce the ulcerated area in patients with diabetic ulcer syndrome. A     clinical trial model to evaluate modifications in size and area is proposed. Patients to be     included will be those with diabetic foot ulcers Graded II accordingly to the University of     Texas wound classification system.   "
5841|NCT03209453|"     To identify the therapeutic effects of short-term family-centered work shop for children with     developmental delays   "
5844|NCT03209414|"     The impact of frailty on immediate and long term outcomes of invasive treatment of coronary     artery disease is not fully characterized. The assessment of frailty may help physicians in     the selection of best treatment option and in the timing and modality of the follow-up. The     FRAilty syndrome in daily Practice of Interventional CArdiology ward (FRAPICA) study is     designed with the aim to validate the use of the Fried frailty scale and instrumental     activities of daily living scale (IADL) as prognostic tools in patients admitted to hospital     for symptomatic coronary artery disease, either stable, unstable, or acute coronary syndrome     (ACS).      The FRAPICA study is a single center prospective study enrolling patients aged ≥65 years. The     aims are (1) to describe Fried frailty scale and IADL scale distribution before hospital     discharge and (2) to investigate the prognostic role of Fried frailty and IADL scores. The     outcomes are: (1) results of invasive treatment, (2) its complications (periinterventional     MI, contrast-induced nephropathy, blood loss), (3) three-year all-cause mortality,     cardiovascular mortality, stroke, myocardial infarction, reintervention, heart failure,     hospital readmission for any cause, and a composite of the above mentioned. Ancillary     analyses will be focused on different clinical presentations, different tools to assess     frailty and risk stratification.      The FRAPICA program will fill critical gaps in the understanding of the relation between     frailty, cardiovascular disease, interventional procedures and outcome. It will enable more     personalized risk assessment and identification of new targets for interventions.   "
8977|NCT03168399|"     To evaluate the acceptability, tolerance and effect on metabolic control of PKU Explore, a     renovated Phe free protein substitute for the dietary management of PKU in children from 6     months to 5 years.   "
5845|NCT03209401|"     This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients     with advanced, solid tumor malignancies who have pre-identified deleterious germline or     somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway     (HR deficient). The trial is designed to assess the efficacy and safety of niraparib plus     carboplatin in patients with evidence of HRD. The primary endpoint will be identifying the     recommended phase 2 dose (RP2D) and schedule of niraparib plus carboplatin, as well as     establishing the anti-tumor efficacy of niraparib plus carboplatin as determined by Response     Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.   "
5846|NCT03209375|"     This non-interventional study will test scoring systems used to identify high risk patients     when they are triaged upon presentation in the Emergency Department (ED) in a single hospital     in the Northwest of England between May and July 2017.E The study will involve collecting     data only from a cohort of 500 consecutive patients who arrive at the ED. Patients who have a     traumatic, purely obstetric or purely psychiatric condition will be excluded.      Patients will be triaged as is routine by nursing and medical staff using various scoring     methods determine whether they are high risk and need urgent, life-saving treatment. In     addition the impression (yes/no) of the triaging nurse and the treating clinician as to     whether the patient will need a life-saving intervention will be collected. Patients will be     followed up for 48 hours to see whether they needed any life-saving treatment, such as     admission to ICU, life-saving surgery, cardiopulmonary resuscitation (CPR), or death.      Each patient's Manchester Triage category, NEWS at presentation, nurse and treating clinician     impressions and a novel score calculated from NEWS data will be collected together with the     outcome data in order to compare the predictive power of the five scoring systems. In this     way the study will test which is the best scoring system for identifying high risk patients     in a timely manner. This is important as it can allow life saving treatment to be delivered     quickly to those patients who need it most and can prevent inappropriate interventions on     patients who do not immediately need them. The study will collect minimal patient information     and will not interfere with or alter their treatment in any way. Only patient data recorded     as part of routine practice is required, which will be collected by members of the direct     care team and will be anonymised prior to analysis.   "
5847|NCT03209362|"     The objective of the study is to evaluate the efficacy and safety of intra-articular     injections of SI-613 compared with placebo for knee OA.   "
5848|NCT03209349|"     This study evaluates how often patients without sedation that receive screening sigmoidoscopy     are able to have their full colon examined without significant discomfort by comparing a new     colonoscopy technique known as the water exchange technique to the traditional air     insufflation technique. It compares the differences between complete colon exam rates for     water exchange when compared to the traditional air technique. Patients will be randomised     and blinded to the procedure type.      Previous studies have shown that the water exchange method is associated with a significant     reduction in discomfort and often allows patients to receive colonoscopy without sedation or     with only minimal sedation. However, the potential for water exchange to be used in the     screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy     screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy     screening, while maintaining minimal levels of discomfort, the investigators will attempt to     scope beyond the distal colon.   "
5849|NCT03209336|"     To study the application of Intersphincteric Resection（ISR）combined with intraoperative     radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications     of Intersphincteric Resection（ISR.      The study is aimed to assess the postoperative acute complication and the short-term acute     efficacy on the patients with middle and low rectal cancer by treated with intraoperative     radiotherapy,especially those with peritoneal inversion rectal cancer.   "
5850|NCT03209323|"     The aim of the study was to assess the influence of volatile induction of general anaesthesia     with sevoflurane using two different techniques and intravenous anaesthesia with propofol on     the possible presence of epileptiform electroencephalograph patterns during the induction of     general anaesthesia. We aimed to verify whether presence of epileptiform patterns (EPs)     defined as polispikes (PS), rhytmic polispikes (RPS), periodic epileptiform discharges (PED)     on Electroencephalographs (EEGs) influence the behaviour of values of the Bispectral Index     (BIS), State (SE) and Response (RE), A-line Auto Regressive Index (AAI) derived from middle     latency auditory evoked potentials (MLAEP) during the induction of general anaesthesia using     abovementioned techniques and such variations may be useful in detection of presence of EPs.   "
5874|NCT03209011|"     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral     replication. In hepatitis B infection, CD4+T Cells are the main effector cells in adaptive     immune response. This study was aimed at investigating the changes of CD4+T Cells frequency     and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside     analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg IFN - alpha     suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function,     or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.   "
5851|NCT03209310|"     Cerebral palsy (CP) can be defined as a group of disorders of movement and posture, causing     activity limitation that are attributed to nonprogressive deficits that take place in the     immature brain. The motor disorders of CP are often accompanied by deficits in sensation,     cognition, communication, perception, behavioral and respiratory system .      Children with CP have many primary motor impairments such as selective mobility, muscle     weakness, abnormal muscle tone, impaired coordination between agonist-antagonist muscles and     insufficient postural control. These motor impairments also lead to secondary problems such     as contractures and bone deformities. Whether primer or secondary, all these problems can     reduce independence in activities of daily living (ADL) by affecting CP children at different     levels.      There are several studies in children with CP that investigate the effects of trunk control     and/or respiratory functions. However, there are very few studies examining the relationship     of these functions which have direct effects on ADL. In these studies, the functions of     children who are more heavily affected and unable to move have been examined. However, there     are no studies examining the effect of trunk control on respiratory muscle strength in     children with CP with a better mobility level. There are many factors affecting both trunk     control and respiratory functions in these children. Therefore, in children with CP, who have     better functional level and can move on their own, revealing the interaction between trunk     control and respiratory functions may contribute significantly to the treatment process. For     this reason, this study was planned to investigate the effect of trunk control on ADL and     respiratory muscle strength in children with CP having a Gross Motor Functional     Classification System (GMFCS) levels of 1 and 2 and to compare them with healthy children.   "
5852|NCT03209297|"     TMD treatment, based on state of the art knowledge derived from clinical studies will be     applied in patients with tinnitus and TMD. When this approach proves to be useful for the     treatment of tinnitus, it offers a new therapeutic option for patients with tinnitus. To     understand how TMD treatment works for patients with tinnitus, we will analyse mediating     factors, i.e. factors that contribute to the therapeutic effect. To help clinicians in their     clinical process we will identify prognostic indicators, i.e. factors that predict a positive     or negative outcome of TMD treatment. This can provide a helpful tool in clinical practice.   "
5853|NCT03209284|"     The aim of this study is to analyze neoformed bone after maxillary sinus lifting with     transcrestal approach, in atrophic crests (≤5 mm residual bone height). Clinical and     laboratory data will be related to maxillo breast anatomy.   "
5854|NCT03209271|"     Fluid boluses are often administered with the aim of improving tissue perfusion in critically     ill patients. It is unclear whether the temperature of the fluid has an impact on the     hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid     bolus with two different temperatures.   "
6749|NCT03197532|"     Women of late to mid reproductive age may participate in a study using novel methodology to     identify subtle changes in the reproductive endocrine axis via daily urine hormone analysis,     which may have important implications for reproduction and may signal reproductive     senescence.   "
5855|NCT03209258|"     Continued uncertainty exists over benefits of early intensive blood pressure (BP) lowering in     acute intracerebral hemorrhage (ICH), related to the non-significant primary outcomes,     patient selection, and discordant results of INTERACT2 and ATACH-II. We designed INTERACT3 to     determine the effectiveness of a goal-directed care bundle of active management (intensive BP     lowering, glycemic control, treatment of pyrexia and reversal of anticoagulation) vs. usual     care in ICH.      INTERACT3 is a large-scale pragmatic clinical trial to provide reliable evidence over the     effectiveness of a widely applicable goal-directed care bundle in acute ICH.   "
5856|NCT03209245|"     Background. Immunotherapy in elderly patients is controversial, and there is still not much     evidences supporting this treatment's safety and efficacy in this population. This study was     performed to evaluate the safety and efficacy of specific injection immunotherapy for house     dust mite allergens in patients over 65 years of age with allergic rhinitis and a confirmed     allergy to house dust mites. The primary endpoint was the change from baseline in the mean     average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS)     difference in the least square means in the label in comparison to placebo.      Materials and methods. The study with double blind, placebo controlled trial was conducted in     one centre. Fifty eight elderly patients with house dust mites allergy and AR were     individually randomized in comparable numbers to one of two parallel groups: two years     perennial AIT with the use Purethal Mites or placebo. Symptoms and medication score were     presented as AAdSS and TCRS. Quality of life based on Rhinoconjunctivitis Quality of Life     Questionnaire (RQLQ), serum allergen specific IgG4 to D.pteronyssinus and D. farinae and Der     p1 and Der p2 were monitoring.   "
5857|NCT03209232|"     Objectives: To examine the effect of accelerated infliximab induction in children with     moderate to severe UC. Design: A multi-center, prospective, randomized, open label study.     Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years     (Overall, 84 patients) with moderate to severe UC who are corticosteroid dependent/resistant     thus planned to receive infliximab induction. Intervention: Group 1 (intervention) will     receive an accelerated induction at 0,1,3 weeks (5 mg/kg) and then at week 7,11,15. Group 2     (standard) will receive a per protocol induction at 0,2,6 weeks (5 mg/kg) and then at week     14. Drug levels will be obtained prior to each infusion in each group (up to week 20).     Further maintenance will be planned according to drug levels at weeks 15 and 14,     respectively. Follow-up will continue without further interventions till 52 weeks following     induction. Main outcome measure: Clinical remission, on infliximab at week 20. Secondary     outcome measures: 1. Colectomy free rates at week 20 and 52. 2. Clinical remission on     infliximab at week 52. 3. Drug levels and anti-drug antibodies prior to last study infusion.     4. Anthropometric and laboratory measures including calprotectin at the end of induction,     week 20 and week 52 5. Changes in fecal microbiome, virome and bile acids content. Sample     size: In order to demonstrate 30% difference in clinical remission rate between groups is     significant, we will need to study 36 children in each group to be able to reject the null     hypothesis that the failure rates between the groups are equal with probability (power) of     80% and a type I error probability of 0.05.   "
5858|NCT03209219|"     Brief summary: This study compares the long-term efficacy and safety of interferon (IFN) α2a     and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral     glucocorticosteroid in patients with refractory Behçet`s uveitis (BDU). Half of the     participants will receive IFNα2a while the other half will receive CsA.   "
5859|NCT03209206|"     The investigators evaluated the efficacy of a single early intravesical instillation of     doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal     ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).   "
5860|NCT03209193|"     Volatile anesthetics, such as sevoflurane and desflurane, are commonly used in patients     undergoing cardiac surgeries including off-pump coronary artery bypass. However, the effect     of volatile anesthetics on microcirculation in patients undergoing off-pump coronary artery     bypass has not been well conducted.   "
5864|NCT03209141|"     Arterial hypertension (AHT) is responsible for important morbidity and mortality. The cardiac     repercussion of AHT is usually assessed by electrocardiography and echocardiography,     time-consuming, technically demanding examinations that require experienced operators, which     limits their use for screening diastolic dysfunction. Alternative tools for the screening of     diastolic function in hypertensive patients are needed. Impedance cardiography (IC) is     presently used in the study of AHT and in the optimization of antihypertensive therapy. It     seems an attractive and economical option to change the clinical approach for screening;     however, its validation in well-defined populations is required to sustain its use in     clinical practice. The IMPEDDANS study aims to validate IC for screening left ventricular     diastolic dysfunction in outclinic patients with AHT, using functional echocardiography as     the clinical standard. Descriptive and analytical study with analysis of the agreement     between the diagnosis of diastolic dysfunction and its degree, as well as the parameters     obtained by impedance cardiography and echocardiography in patients with AHT.   "
5865|NCT03209128|"     Hippocampus and amygdala are parts of the brain involved in the recognition of emotions,     memories, memory, language ... It is therefore very important to protect them during     irradiation of the brain.      The aim of this study is to evaluate cerebral irradiation with saving hippocampus and     amygdala protects these brain functions in patients with small cell lung cancer (SCLC)     Radiotherapy of the brain   "
5866|NCT03209115|"     Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra     canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases   "
7718|NCT03184857|"     Two stage sinus lifting using Nano hydroxyapatite particles [Nanostreams] versus Deprotenized     bovine bone allograft [Tutogen] : Randomized clinical trial.      comparing between Height of new bone formation, Bone area percent( Histomorphometric)   "
5867|NCT03209102|"     This study aims to better understand the behavioral, neurobiological and hormonal     underpinnings of stress and reward reactivity of adolescents suffering from borderline     personality disorder compared to healthy adolescents by a multimodal approach based on     clinical assessments, structural and functional mri and experimental acute stress exposure.   "
5868|NCT03209089|"     This is a multi-centre observational, ambispective study, which will retrospectively and     prospectively collect clinical variables and socio-demographic data from medical records of     patients with type 2 diabetes mellitus (T2DM) initiated with dapagliflozin by general     practitioners (GPs) and endocrinologists in real-life setting. It is anticipated that patient     recruitment will last 8 months (from Q3 2017 to Q1 2018) and each patient will be followed     during the second visit 6±3 months later after the first visit. There are 2 time points:        -  Baseline data: baseline data are defined as data available within 3 months prior to the          first dose of dapagliflozin. In case of presence of multiple data values within baseline          period the most recent pre-dose value will be selected        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary          analysis will be focused on data available at 6±3 months after the first visit. In case          of discontinuation dapagliflozin, data will be collected at routine visit within 3-month          time frame after the last dose.   "
5869|NCT03209076|"     Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for     rectal cancer.      Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.   "
5870|NCT03209063|"     Recurrent miscarriage is a pregnancy loss before 20 weeks of gestation. The recurrent     pregnancy loss usually occurring in the first trimester of gestation and its rate is quite     high (15-20% even in full reproductive period) . In 2012, the American Society for     Reproductive Medicine Practice Committee issued a statement that defined recurrent pregnancy     loss as a disease distinct from infertility defined by two or more failed consecutive     pregnancies.   "
5871|NCT03209050|"     Pre-market Investigational device exemption study evaluating the safety and efficacy of the     Surfacer System to facilitate stable upper body central venous access suitable for any     conventional catheter.   "
5872|NCT03209037|"     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral     replication. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive     immune response. This study was aimed at investigating the changes of CD8+T cells frequency     and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside     analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed     the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN     - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.   "
5873|NCT03209024|"     Background: Hypertension is the leading attributable risk factor for cardiovascular disease     and death globally. In diagnosing and monitoring hypertensive patient population, home blood     pressure monitoring (HBPM) has been shown to be superior to the office-based blood pressure     (BP) measurement as a predictor of cardiovascular disease and total mortality. However, the     conventional method of HBPM utilizing handwritten BP logbooks has known shortcomings, mainly     attributable to inaccuracy and underreporting of data, as well as the failure to bring the     logbooks to the regular outpatient appointments. In recent years, the availability of home BP     devices with Bluetooth® technology on the market, the increasingly widespread use of     smartphones, and the development of mobile applications (apps) that complement Bluetooth®     enabled BP monitors have expanded the potential for an accurate log of BP data to be     accessible to clinicians. Our study's primary aim is to compare the level of HBPM recording     fidelity using smartphone app versus using a handwritten logbook among the multi-ethnic     hypertensive patient population seen in a district polyclinic located in Pasir Ris,     Singapore. Patient acceptability of the two recording modalities and the association between     the home blood pressure recording fidelity and the patients' socio-demographic background,     self-care profile, clinical factors, and level of exposure to technology is also assessed as     exploratory aims. Our main hypothesis is that the level of fidelity in HBPM recording,     defined as the proportion of scheduled number of home blood pressure readings that is     successfully recorded, regimen compliant, and made available at the final follow up visit,     would be higher for patients who use a smartphone app versus those who maintain a handwritten     logbook.      Methods/design: Open, randomized controlled trial of 80 patients seen at Pasir Ris Polyclinic     randomized to either intervention or control arm and assessed after a 3-week follow up period      Intervention arm: Participants randomized to intervention arm follow a 3-week HBPM regimen     and wirelessly record the BP readings onto a smartphone app using Bluetooth® technology.      Control arm: Participants randomized to control arm follow a 3-week HBPM regimen (identical     to intervention arm) and manually record the BP readings onto a handwritten logbook.      Participants: A convenience sample of 80 patients visiting the study polyclinic was obtained     during the recruitment period (15 Mar 2017 - 15 June 2017).      Outcomes: A trained outcomes assessor will assess each participant's home BP record brought     to the final follow up visit at 3 weeks post-randomization. The primary outcome will be HBPM     recording fidelity, defined as the proportion of scheduled number of home blood pressure     readings that is successfully recorded, regimen compliant, and made available at the final     follow up visit. The participants' level of discomfort during the study, their willingness to     incorporate into their healthcare management the modality of HBPM to which they were     assigned, and their overall impression on their study participation will be assessed by a     participant acceptability questionnaire.   "
15267|NCT03085628|"     The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences     social reward processing and whether the effects are context- and sex-dependent.   "
5875|NCT03208998|"     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral     replication. In hepatitis B infection, NKs are the main effector cells in early antiviral     innate immune response. This study was aimed at investigating the changes of NKs frequency     and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside     analog(ue) therapy.Meanwhile, investigators want to verify whether Peg IFN - alpha suppressed     the virus and the reduction of virus led to the recovery of NKs function, or Peg IFN - alpha     enhanced NKs function which gave rise to the decline of the virus.   "
5876|NCT03208985|"     This study is designed to assess whether consumers select and use ella® (ulipristal acetate     30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in     an OTC-like setting.   "
5877|NCT03208972|"     The study compares in a randomized controlled way two stimulation methods. One of these     stimulation methods implements a new insight in ovarian follicular growth. If this novel     method of stimulation proves to be as efficient as the classical stimulation protocols, there     might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also     the overall IVf costs significantly.   "
5878|NCT03208959|"     IDO1 is expressed in a wide variety of human tumors (eg. bladder, breast, colon, DLBCL,     HNSCC, lung, ovarian, uterine, renal…), and contributes to tumoral resistance. HTI-1090 (also     referred as SHR9146 in nonclinical study reports) is an orally bioavailable, highly potent,     novel small-molecule IDO1/TDO dual inhibitor, with favorable preclinical oral bioavailability     and safety profiles.   "
5879|NCT03208946|"     The aim of this study is to evaluate the effect of carboxymethyl-lysine (CML) on the levels     of absorption and excretion of CML, and in the microbiota of healthy adults. To achieve the     objective, a randomized clinical trial will be carried out. Before the intervention, subjects     will have a washout period for seven days, then they will be randomly assigned to either a     high-CML or to a low-CML diet for 5 days. Both groups will consume the foods provided by the     researchers at the research center. Diets for this intervention will be based on an     isocaloric diet that will include breakfast, lunch, snacks and dinner.      Blood samples will be taken the first day, the second day of the intervention, and after the     five days of the intervention. Urine and fecal samples will be taken the day before the     intervention and after the intervention. CML levels will be measured by Liquid chromatography     tandem-mass spectrometry in serum and urine samples to evaluate the levels of absorption and     excretion. DNA extraction from the fecal sample will be carried out by a commercial kit.     Bacterial log10 number of copies will be determined by using q-PCR.   "
5880|NCT03208933|"     This study is a national, multicenter, interventional, non-randomized, non-controlled,     open-label study to assess the effectiveness of pirfenidone in participants with IPF in     Russian clinical practice.   "
5881|NCT03208920|"     The purpose of this study is to determine if high-dose PUFA supplementation in patients     undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.   "
5882|NCT03208907|"     Plasmodium vivax can be cause of severe malaria and mortality. There are serious public     health implications associated with cases of P. vivax resistant to Chloroquine in the     Americas as well there are efforts of many countries to eliminate this disease. In this way,     it is critically important to evaluate an alternative radical cure treatment efficient to     amazon scenario. The objectives of this trial are to demonstrate the superiority of adequate     parasitological response at D42 of Dihydroartemisinin plus Piperaquine (DHA-PQP or     Eurartesim®) versus Chloroquine and to evaluate the proportion of failure until D180     considering different starting days of Primaquine (0.50 mg/kg/day) for 14 days. It is an     open, 4 arms, randomised, comparative trial. Total of 460 patients must be included. To     demonstrate the superiority of DHA-PQP compared to Chloroquine, the 95% confidence interval     of the difference observed between both treatment success rates will be determined. Each     recurrence will be passively and actively detected for 180 days.   "
5883|NCT03208894|"     to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of     newborn   "
5884|NCT03208881|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In     the parent trial, patients will be subjected to an 8-week diet intervention phase including a     low-calorie diet and dietetic counseling, after which patients will be randomised to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.      This substudy aims to investigate any changes in the thickness of Adventitia, Extra-media     (EMT) and veia jugularis assessed by ultrasound in relation to an initial 8-week weight loss     intervention.      Change will be assessed by grey-scale ultrasound, the area measured will be from the anterior     wall of arteria carotis interna to the jugular vein including the wall of the vein,     subsequent the thickness of the artery will be subtracted to measure the thickness of the of     Adventitia, Extra-media (EMT) and veia jugularis interna compelx.   "
5885|NCT03208868|"     Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible     complication in cirrhosis that increases morbidity and mortality before, during and after     liver transplantation. No proven treatments exist for the prevention or reversal of     sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown.     Based on compelling preliminary studies and those of the co investigator, investigators     hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a     myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in     reduced protein synthesis and increased autophagy. Investigators further postulate that     leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the     skeletal muscle of cirrhotics. The consequent increase in protein synthesis reduced autophagy     will result in an increase in skeletal muscle mass. Investigators will test these hypotheses     by quantifying the response to acute and long term (3 month) administration of leucine     enriched essential amino acid (EAA/LEU) compared with an isonitrogenous isocaloric     non-essential balanced amino acid mixture (does not stimulate protein synthesis) in cirrhotic     patients. Fractional protein synthesis rate (FSR) in skeletal muscle, responses of the     molecular regulatory pathways of skeletal muscle protein synthesis, and autophagy flux will     be quantified in the acute and long term protocols. Tracer studies using L-[D5]-phenylalanine     (Phe) as a primed constant infusion (prime 2µmol.kg-1.hr-1; constant 0.05 µmol.kg-1.hr-1)     with and L [ring-D2] tyrosine, forearm plethysmography, and sequential skeletal muscle     biopsies (total of 3 per study subject) will be used to quantify these outcomes.     Anthropometric, clinical and body composition measures will be additional outcome measures     for the long term intervention. Expression of regulatory signaling proteins, myostatin, IGF-1     (insulin like growth factor) , phospho-Akt, phospho-AMPK (activated protein kinase),     phospho-mTOR and phospho-p70s6k will be quantified by Western immunoblots. Autophagy flux     will be measured by quantifying expression of the autophagosome proteins.   "
5886|NCT03208855|"     Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are     independently linked to reduced quality of life, disability, and high healthcare costs.     Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative     sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with     SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex     bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain     high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication,     withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of     sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the     most well documented predictor of substance use relapse. Treatment specifically targeting     chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a     well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary     residential treatment programs that specifically treat chronic insomnia during acute SUDs     treatment. We propose that improved treatment of insomnia as part of a comprehensive     reinforcement-based outpatient treatment program will provide an efficient and cost effective     opportunity to improve standard outpatient SUD. Converging evidence suggests that     prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and     improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will     engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual     for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a     new standardization of outpatient care. We hypothesize that a CBT-I intervention can be     implemented as part of an evidence-based SUD treatment program within a residential facility.   "
9352|NCT03163524|"     This is a randomised controlled trial to test the impact of a modified e-coupon service,     delivered through SMS, on uptake of sexual and reproductive health services among women     calling a free hotline in Uganda.   "
5887|NCT03208842|"     After gaining verbal consent , Patients included in this study will be subjected to:        1. history taking :             -  peronal history .             -  obstetric history.             -  past history        2. general examination including vital signs        3. abominal and pelvic examination        4. the patient will be examined son graphically at 3 visits             1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with               partially filled bladder to nullify effect of anteversion of the uterus for               assessment of---the site of the intrauterine gestational sac in relation to the               endometrial cavity . For the purposes of this study and to obtain consistent               findings, it was decided to have only five subgroups of gestational site               implantation in relation to the endometrial cavity (Fig. 2):                  1. anterior,                  2. posterior,                  3. Fundal,                  4. low-lying anterior,\                  5. low lying posterior We adopted the definition of implantation site from                    previous publication (Abdallah et al., 2012). The implantation site is                    visualized in the sagittal plane as a hyperechoic ring that occupies one side                    of the implanted gestational sac and protrudes into the endometrial lumen It                    represents the maternal decidual reaction and the beginning of maternal-fetal                    circulation. This area is also believed to be responsible for future placental                    formation and development (Brosens and Gellersen, 2010) Distance between the                    implantation site and the internal cervical ostium (os). This was taken from                    the lower end of the hyperechoic trophoblast ring of the gestational sac to                    the internal cervical os in the sagittal plane.                       -  doppler assessment of the retro chorionic blood flow in the area behind                         the maximum chorionic tissue to detect sensitivity index (RI),in cases of                         low gestational sac Doppler assessment of peri trophoplastic blood flow                         will be assessed.             2. then the patient will be enrolled during routine ANC till delivery and data               collected at32-34 weeks gestation regarding placental site will be correlated with               1st data and data at delivery   "
5888|NCT03208829|"     Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One     group will receive a booklet with guidelines for postoperative care, while the other group     will participate in face-to-face sessions with exercises with emphasis on muscle     strengthening.   "
5889|NCT03208816|"     This study will be conducted at La Liga Contra el Cancer in San Pedro Sula, Honduras. The     overall objective of this project is to improve symptom management for patients undergoing     chemotherapy in Honduras. The first step in this line of research is a proof of concept     feasibility study in which the investigators will demonstrate their ability to train nurses     to administer a non-pharmacological, telephone-delivered, symptom management program for     chemotherapy patients.   "
5890|NCT03208803|"     In patients with myelofibrosis, ruxolitinib is a current therapeutic option, which has     demonstrated rapid and durable reduction in splenomegaly and improved disease-related     symptoms. Anemia is another frequent issue in myelofibrosis. Consistent with its JAK2     signalling inhibition, ruxolitinib therapy has been shown to be detrimental on the hemoglobin     level, increasing the depth of anemia or transfusion need.      Despite potential antagonistic mechanisms of action on Janus Kinase 2, some responses on     anemia have been reported with the addition of Erythropoiesis-stimulating Agent to     ruxolitinib in a small subset of patients in the COMFORT II study.      Ruxo-EPO is an observational study aimed to better assess the combination of     Erythropoiesis-stimulating Agent and a Janus Kinase 2 inhibitor for therapeutic efficacy on     anemia, Myelofibrosis evolution and for tolerance, in a larger cohort of patients treated for     myelofibrosis in general practice.   "
5891|NCT03208790|"     The present randomized, controlled, parallel-grouped trial includes 81 patients (aged 18 to     75 years) suffering from oral potential premalignant lesions. Patients will be randomly     assigned into 3 equal groups: Group A:Thymoquinone group 100mg Group B:Thymoquinone group     200mg Group C:Control group (placebo)   "
5892|NCT03208777|"     Colorectal carcinoma is a heterogeneous disease that is caused by the interaction of genetic     and environmental factors. colorectal carcinoma encompasses a complex disease with different     molecular pathways and biological characteristics arising from a multi-step process that     implicates several genetic and epigenetic events . The multi-step genetic model involves the     loss of function of tumor suppressor genes, such as adenomatous polyposis coli (APC),     Telomeres could be a promising marker due to the fact that their lengths change in the     colorectal polyp-carcinoma sequence . Moreover, telomere length (TL) is altered in blood     cells in patients with colorectal carcinoma        -  These findings could suggest that changes in TL may take place before the development of          the tumor .      The two main forms of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's     disease (CD) are characterized by chronic intestinal inflammation and risk of progression to     colon cancer. One proposed cause of the latter characteristic is chromosome instability,     since the rearrangement of genetic material can lead to activation of oncogenes, loss of     tumor suppressor genes and other changes that lead to uncontrolled cell growth. Chromosome     instability is particularly associated with UC and has been observed in colon epithelial     cells and peripheral blood mononuclear cell. Since genomic instability in peripheral blood     mononuclear cells (PBMCs) has been used as a biomarker for global cancer risk in a number of     diseases, the latter observation suggests the possibility of a chromosome instability     syndrome in UC that could affect all tissues. One possible cause of chromosome instability is     telomere dysfunction .   "
5935|NCT03208218|"     The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by     comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg)     when administered a single-dose to healthy male volunteers.   "
8815|NCT03170531|"     The purpose of this study is to assess the image quality improvement provided by a custom MR     spine coil in comparison with the FDA approved coil when used for radiotherapy treatment     planning.   "
5893|NCT03208764|"     A Prospective, Open labeled, multi-Center, Evaluation of the Efficacy Safety and Tolerability     of Nitric Oxide Given Intermittently via Inhalation to Subjects with Cystic Fibrosis     diagnosed with NTM (specifically MABSC).      Nitric Oxide (NO) has been shown to play a critical role in various biological functions. In     the airways, NO is considered to play a key role in the innate immune system in which the     first-line of host defense against microbes is built.      In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses     anti-microbial activity against a wide variety of phyla including fungi, and     antibiotic-resistance bacteria.      In this study the investigators wish to evaluate the efficacy, safety and tolerability of 160     ppm Nitric Oxide intermittently delivered via inhalation to subjects with Cystic Fibrosis     (CF) infected with Non-tuberculosis mycobacteria (NTM), specifically with MABSC.   "
5894|NCT03208751|"     Regular exercise training has shown to improve exercise capacity in patients with     cardiovascular disease. The feasibility and transferability of exercise training in a     community based cardiovascular rehabilitation setting is currently less well investigated.     The objective of this study is to translate regular exercise training into a community based     setting. A 6 months training intervention program with lifestyle counseling is performed,     with both supervised training in rehabilitation centres as well as home based training. The     aim of the project is to implement this program for a wider patient population and to improve     exercise capacity, diastolic function as well as cardiometabolic parameters.   "
6006|NCT03207282|"     The purpose of this study is to estimate the prevalence of Treatment Resistant Depression     (TRD) among Major Depressive Disorder (MDD) participants being treated in a psychiatry     reference site (example, clinic, ambulatory, hospital, day-hospital) in 4 Latin American     countries: Argentina, Brazil, Colombia and Mexico; and to evaluate all and depression-related     healthcare resource utilization in TRD participants.   "
5895|NCT03208738|"     Concept: Alcohol misuse is common among Veterans with PTSD. It has been proposed that this     high comorbidity is the result of self-medication, with alcohol being used to alleviate     common PTSD symptoms (e.g., hyperarousal, sleep problems). Given this high prevalence and     functional relationship, researchers at the BSD of the NCPTSD developed the VetChange     self-management website to concurrently address these conditions. In a large scale RCT,     VetChange has shown efficacy to reduce both alcohol misuse and PTSD symptoms. Unfortunately,     the recently launched publicly available VetChange website (Vetchange.org) has been plagued     by a high rate of visitors not completing the mandatory registration process, which is     required for repeated use. Based on the promising findings of the VetChange research, the D&T     Division partnered with the BSD Division to develop the VetChange mobile app, which is set to     be released to the public very soon. However, unlike the VetChange website, the app has not     yet been evaluated and has the advantage of allowing users to easily obtain it without having     to register and repeatedly log on through an Internet connection.      This research partnership between the D&T and BSD Divisions will extend and enhance an     ongoing successful cross-center collaboration in a high priority topic for the larger Center.     The purpose of this proposal is to conduct a pilot evaluation of the VetChange mobile app in     order to test its feasibility, acceptability, and potential efficacy to reduce alcohol     consumption, PTSD severity, and improve psychosocial functioning among Veterans with PTSD who     exhibit signs of problem drinking. In this study, 280 Veterans with problem drinking and     clinically significant PTSD symptoms will be recruited using social media and randomized in     equal numbers to receive one of four conditions: 1) Assessment only, 2) VetChange mobile app     only, 3) AFT plus the VetChange mobile app supplemented with a package of supportive     accountability tools (VetChange+). In addition to receiving the mobile app, VetChange+     participants will receive SMS reminders to log drinking behavior using the mobile app. The     investigators will track objective use of the VetChange mobile app to assess feasibility, and     this usage data will also be used in real-time to tailor the content of text messages     provided to participants in the VetChange+ condition. Participants will complete measures of     alcohol use, functional well-being, and PTSD symptoms at baseline and again after 8 weeks     (posttreatment). At post-treatment, participants in the VetChange app arms of the study will     also be asked to report their level of satisfaction with the app and to complete a brief     qualitative evaluation of their experience using the VetChange mobile app.      Results of this pilot study will be used to characterize the feasibility, acceptability, and     potential efficacy of a mobile app-based self-management intervention to reduce problem     drinking behavior in Veterans with PTSD, will inform optimization of the intervention, and     will serve as the foundation for subsequent proposals for extramural funding.   "
5896|NCT03208725|"     The CHAIN Network aims to identify modifiable biomedical and social factors driving the     greatly increased risk of mortality among young undernourished children admitted to hospital     with acute illness, as inpatients and after discharge. The study will inform priorities,     risks and targeting for multi-faceted interventional trials.      CHAIN is a multi-centre cohort study with a nested case control analysis of stored biological     samples. Study sites are located in Africa and South Asia. Children will be recruited at     admission to hospital, stratified by nutritional status. Exposures will be assessed at     admission, during hospitalisation, at discharge, and at two time points after discharge. The     main outcomes of interest are mortality, re-admission to hospital and failure of nutritional     recovery up to 180 days after discharge. To determine community health norms, an additional     sample of children living in the same communities will be enrolled and assessed at one time     point only.   "
5897|NCT03208712|"     This is a single-arm, single-site pilot of Radium-223 (55 kBq/kg) IV q3 weeks for up to 6     doses in combination with Atezolizumab 1200mg IV once every 3 weeks until investigator     determined lack of benefit, unacceptable toxicity, or 17 doses in patients with urothelial     carcinoma with bone metastases who have disease progression after platinum-containing     chemotherapy.   "
5898|NCT03208699|"     Eating disorders (ED) are often undetected in the general population resulting in delayed     treatment. The SCOFF questionnaire has been validated for eating disorders screening in     primary care, but does not identify the type of eating disorder.      Objective: Investigators evaluated the performance of a clinical algorithm (ExpaliTM)     combining answers to SCOFF questionnaire with Body Mass Index (BMI) to identify four Broad     Categories of ED derived from DSM-5.      Design: Clinical algorithm (ExpaliTM) was developped from 104 combinations of BMI levels and     answers to five SCOFF questions. Two senior ED specialists allocated each combination to one     of the four Broad Categories of ED (DSM-5 diagnostics): restrictive disorder (anorexia     nervosa typical, atypical and restrictive food intake disorders), bulimic disorder (typical     and with low frequency or duration), hyperphagic disorder (binge eating disorders typical and     with low frequency or duration) and other specified ED. The performance of ExpaliTM was     evaluated on data from patients referred to the Nutrition Department including a precise     DSM-5 diagnosis of ED, a positive SCOFF test (at least 2 yes answers) and BMI. Sensitivity,     specificity values with a 95% confidence interval (95% CI) and Youden index were calculated     for each category.   "
5899|NCT03208686|"     The purpose of this application is to create and implement a targeted, culturally grounded,     diabetes self-management intervention for Black men that uses social support, mobile health,     and remote sensing technology to improve diabetes-related outcomes.   "
5900|NCT03208673|"     This is an open label study of Optive eyedrops and gel combination for day and night dry eye     management   "
5901|NCT03208660|"     This study is conducted to assess the retention rate of Fycompa when given in routine     clinical care.   "
5902|NCT03208647|"     To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially     the comprehensive multiple factors risks. The author conducted a case-control research     included 338 AA cases and 1464 controls. Subjects were surveyed using same standard     questionnaire including personal data, past histories of diseases, family history and     histories of occupational and daily exposure to harmful substances. Single and multiple     Logistic regression analyses were made using SPSS17.0 on the dates to study potential factors     in the development of AA.   "
5903|NCT03208634|"     Robotic rehabilitation is promising to promote function in stroke patients. The assist as     needed training paradigm has shown to stimulate neuroplasticity but often cannot be used     because stroke patients are too impaired to actively control the robot against gravity. Aim     of this study is to present a novel robotic approach based on fully assisted functional     movements and to examine the effect of the intervention in terms of motor function     improvement in subjects with chronic stroke in the short term and at 6-month follow up. A     preliminary evaluation of the effectiveness of the intervention in improving activity and     participation in the short term is also performed. Further, the study aims to verify whether     some instrumental measures (using kinematics, EMG and EEG) may help gain insight into the     mechanisms leading to improved motor ability following the robotic intervention and can be     used to predict functional recovery.   "
5925|NCT03208348|"     Drs. from the Mayo Clinic Rochester will plan and execute a feasibility study of the phase I     prototype version of the Virtual Reality exposure therapy system. Dr. X, who has significant     experience in evaluating patient experiences and opinions of technologies intended to change     behavior, will oversee a qualitative study to examine the prototype system. Twenty children     with generalized anxiety disorder with perfectionism who have received less than 3 treatment     sessions and a parent will be recruited to pilot the Virtual Reality system.   "
5904|NCT03208621|"     Objective: To evaluate the impact and cost-effectiveness of FDG-PET/CT (PET) and diagnostic     laparoscopy (DLS) in addition to initial staging by CT and gastroscopy in patients with     advanced gastric cancer.      Hypothesis: The study hypothesizes that performing DLS and PET for advanced gastric     adenocarcinomas results in a reduction in the number of futile gastrectomies performed and a     favorable cost-effectiveness. According to the literature, in 27% of patients a futile     gastrectomy can be prevented, and the annual cost-reduction is an estimated €916.438.      Study design: The study design is a prospective observational study. Study population: The     study population consists of patients with a surgically resectable, advanced gastric     adenocarcinoma (cT3-4a,N0-3,M0), that are scheduled for treatment with curative intent after     initial staging with gastroscopy and CT.      Usual care / comparison: Both PET and DLS were recently included in the new Dutch guidelines     for the treatment of gastric cancer, as staging modalities for advanced (T3-4) tumors after     initial staging. The costs of the study population will be compared to retrospective data of     patients who underwent curative surgery (gastrectomy) after initial staging with CT alone.      Outcome measures: The primary outcome of this study will be the proportion of patients in     whom the PET or DLS lead to a change in treatment strategy. The accuracy of each modality     will be analyzed separately. Secondary outcome parameters will be diagnostic performance,     morbidity and mortality, quality of life, cost-reduction and cost-effectiveness.      Sample size: Based on the expectation that 22% of patients will have a change in treatment     strategy, at least 239 patients will be needed for this study to demonstrate that the     diagnostic modalities in the new guideline are break-even. Approximately 543 patients will be     eligible for the study in 36 months.      Cost-effectiveness analysis: A state-of-the-art cost-effectiveness analysis and budget impact     analysis will be performed on the additive value of PET and DLS by both prospective and     retrospective data collection   "
5905|NCT03208608|"     The present cross-sectional study aims to examine the cognitive capabilities of older adults,     aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable     Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals     (RBANS-H). Secondly, the correlations between cognition on the one hand and hearing and     speech reception capabilities on the other hand are investigated. For this purpose, twenty     participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89,     bringing the total number to 80. Three questionnaires are administered to the participants:     the Health Utilities Index-2/3 (HUI 2/3), Dizziness Handicap Inventory (DHI) and a general     questionnaire on education and profession, medical history, hearing aid use and tinnitus.     Also an audiological examination is performed, including pure tone audiometry, speech in     quiet and speech in noise audiometry. Finally, cognition is assessed using the RBANS-H.   "
5906|NCT03208595|"     Characterization of the female genital tract microbiome in women undergoing IVF treatment   "
5907|NCT03208582|"     Osteogenesis Imperfecta(OI) is an inherited disorder characterised by extreme fragility of     the bones. Bones often break from little or no apparent cause.      Current available medicine can increase bone strength by making bones wider and filling in     the holes in the bone walls that weaken it. These medicines are bisphosphonates, given either     by a drip intravenously (eg pamidronate), or taken by mouth (eg risedronate). Their major     action is to prevent bone breakdown by stopping the normal process of removing and then     replacing old bone tissue, so in some parts of the bone, new bone formation is actually     reduced. Most studies of bisphosphonates in children with OI have shown increased bone     mineral density and improved exercise tolerance that could positively affect new bone     formation; some have shown reduced fracture rate. Bone is highly responsive to mechanical     stimulation. Whole body vibration (WBV) is a form of mechanical stimulation that has been     shown to improve bone mineral density in some individuals with narrow bones.      Little is known whether bisphosphonates affect the response of the skeleton to mechanical     stimulation. We will determine the response to mechanical stimulation in children with OI by     looking at bone turnover markers following WBV in those who are and are not treated with     bisphosphonates.      The results from this study will help us to understand whether skeleton in children with OI     is normally responsive to mechanical stimulation, and whether bisphosphonates alter that     responsiveness in a way that is either beneficial or not for increasing bone strength.   "
5908|NCT03208569|"     There is increasing evidence that medications with anticholinergic effects may adversely     affect cognitive function. Older adults are particularly sensitive to anticholinergic effects     because of changes in pharmacokinetics and pharmacodynamics. The cumulative effect of taking     one or more medicines with anticholinergic properties is referred to as anticholinergic     burden. To estimate the anticholinergic burden, Boustani et al. published the Anticholinergic     Cognitive Burden scale (2008). The objective of this study is to measure the association     between the use of medications with anticholinergic properties (identified by the ACB scale)     and cognitive performance. Anticholinergic use and cognitive performance will be measured at     baseline and 6-months follow-up.   "
5936|NCT03208205|"     The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in pediatric     retinal detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) as well as     complications and factors influencing the final anatomical and functional results.      This is retrospective consecutive case series of 14 eyes treated with primary PPV for RD     repair. Average postoperative follow-up period is 34 months.   "
5909|NCT03208556|"     PD1 pathway is critical in determining the response to CAR T cell therapy. Emerging data     suggested that Inhibition of PD1 could enhance the efficacy of CAR T cell therapy. iPD1 CD19     eCAR T cells is an enhanced version of the classical 2nd generation anti-CD19     4-1BB-costimulatory chimeric antigen receptor engineered T cells with cell-intrinsic PD1     inhibition by incorporation of a PD1 shRNA-expressing cassette in the CAR lentivector. This     design will enhance the anti-tumor activities of CAR T cells by inhibiting PD1 induction     after CAR T cell activation. This pilot, single arm, one center, dose-escalation, open label     study is to determine the safety and efficacy of iPD1 CD19 eCAR T cells in relapsed or     refractory CD19 positive lymphoma.      Subjects will be given a lymphodepletion chemotherapy comprised of Fludarabine and     cyclophosphamide prior to CAR T cell infusion. The chemotherapy is completed 1 to 4 days     before the first dost of iPD1 CD19 eCAR T cells.   "
5911|NCT03208530|"     Test the acceptability and feasibility of a brief motivational interview intervention to     facilitate advance care planning (ACP) conversations for older adults with serious co-morbid     illness being discharged from the emergency department (ED). The investigators will interview     the participants to understand their perception of the intervention and collect     patient-reported outcomes data after leaving the ED.   "
5926|NCT03208335|"     Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the     rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment     is commonly used in unresectable HCC patients. Preclinical models have shown that     anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make     it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently.     This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy     in the treatment of HCC.   "
8571|NCT03173716|"     This study is being done to find out if and how much the use of RTMPE improves a provider's     confidence in the diagnosis they assign. This is important because the use of RTMPE may     decrease the need for any additional invasive testing.   "
5912|NCT03208517|"     The primary objective of this study is to determine whether a Person Centred Care online     training programme confers significant benefit in terms of improving staff attitudes and     quality of care of residents with dementia living in care homes, in comparison to enhanced     usual training for professional care staff.      There is considerable interest in e-learning and dementia from care home providers.     Significant investment has been made into the production of resources for care staff but to     date there appears to be no, or very limited, evaluation of their effectiveness.      The aim is to provide a cost-effective, simple and practical evidence-based intervention,     improving staff attitudes towards residents with dementia and quality of care provision. The     trial will be a randomized controlled 3-arm cluster single blind trial that will take place     over 9 months in 24 care homes in the UK.   "
5913|NCT03208504|"     A prospective, open-label, non-randomized, interventional clinical study, sponsored by     Endospan Ltd. Subjects will be followed-up for five years.   "
5914|NCT03208491|"     The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of     patients suffering from Alzheimer's disease using a serious game providing cognitive and     physical straining compared to a usual management. Among the secondary objectives it is     important to assess the real life feasibility in different types of care structures.   "
5915|NCT03208478|"     Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries.     Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful     orthopedic procedure performed after traumatic injury to the knee. Many patients undergoing     ACL reconstruction receive a nerve block as part of their anesthetic care. These blocks can     be performed in different locations along the femoral nerve, with advantages and     disadvantages to each location. Recently published evidence indicates that there is no     short-term difference in pain control between the two commonly-targeted locations (Adductor     Canal and Femoral). However, studies involving patients undergoing total knee arthroplasty     indicate that femoral blocks provide better pain control with movement than adductor canal     blocks. As many patients undergoing ACL reconstruction use continuous passive motion (CPM)     machines as part of rehabilitation starting on post-operative day one, the investigators     hypothesize that pain control and quality of recovery in the first 48 hours after surgery     will be superior with a continuous femoral block than with a continuous adductor canal block.     The investigators plan to study this by randomizing patients presenting for ACL     reconstruction to receive either a continuous femoral or continuous adductor canal block     (both considered adequate means of pain control), and following them to 48 hours to determine     the level of pain, quality of recovery score, opioid use, and CPM compliance.   "
5916|NCT03208465|"     This trial evaluates the effects of Empagliflozin versus Sitagliptin, in addition to standard     of care, on global myocardial perfusion reserve using dynamic single-photon emission computed     tomography (SPECT) images.   "
5917|NCT03208452|"     To evaluate the correlation between the effect of intraoperative magnesium sulfate infusion     and the incidence of emergence agitation after pediatric ophthalmic surgery   "
5918|NCT03208439|"     A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling     system is introduced to stroke survivors for lower-limb rehabilitation. The system will     generate NMES to targeted muscle according to the user's voluntary intention, represented by     the EMG signal during cycling.   "
5919|NCT03208426|"     Objectives: A recent randomized trial showed that 14-day sequential therapy containing high     dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether     the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains     unknown. Therefore, the investigators aimed to compare the eradication rates and long term     re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10     days in the second line treatment.   "
5920|NCT03208413|"     Purpose: This early phase II clinical trial aims to evaluate the indications, therapeutic     effects and side effects of thalidomide in radiation-induced brain injury.      Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University /     Yameitang.      Primary outcome measure: clinical efficacy, which is determined by brain edema volume in     Brain MRI (Magnetic resonance imaging) and neurological functions using LENT/SOMA scales     before and after the treatment of thalidomide.   "
5921|NCT03208400|"     While knowledge on the neurobiological signatures of fear and anxiety disorders and, in     particular, their association with treatment outcome is accumulating, clinical translation     still awaits empirical proof of evidence. Exposure-based cognitive-behavioral therapy (CBT)     is a first-line treatment, but clinically significant change is only seen in approx. 50-65%     of patients. Patient stratification is a powerful option to increase treatment response;     however, developing prognostic markers suitable for single-patient predictions still is in     its infancy and crucially requires external cross-validation embedded within an a priori     prediction approach - a procedure yet largely missing in the field of biomarker research.     Employing a bicentric strategy the aim of this study is to test the hypothesis that a priori     prediction of treatment outcome based on neurobiological measures is possible in a second,     independent sample. Building upon findings from previous mechanistic studies, These will be     incorporated into the development of a predictive pattern comprising fear-relevant genotypes     and molecules targeting neuropeptides, related epigenetic signatures as well as     neurofunctional activation patterns associated with fear circuitry functions, and clinical     data. Pre-treatment neurobiological signatures will be tested for their potential as a     predictive response marker towards behavioral exposure (virtual reality exposure treatment     (VRET) and an in vivo behavioral avoidance test) in a model disorder of fear circuitry     dysfunctions (spider phobia). Multivariate pattern analyses employing a machine learning     framework will be used to generate predictions on the individual patient level and to     cross-validate markers in a second, independent sample. While at site A predictions will be     generated following completion of the treatment, response will be predicted at site B a     priori, but in a double-blind manner. Comparison of observed vs. predicted response rates     will serve as a test of hypothesis. In addition, neuroplastic (on a subsample) and epigenetic     changes induced by VRET treatment will be assessed following treatment and, in case of     epigenetics, also after 6-months follow-up.   "
5922|NCT03208387|"     The goal of this study is to learn about the cognitive and behavioral functioning of children     being treated for cancer.   "
5923|NCT03208374|"     This study will recruit approximately 5,000 patients with histologically confirmed cancer who     have successfully completed MSK-IMPACT panel testing and collect information about tumor     genetic results and patient exercise behavior history.   "
5924|NCT03208361|"     This study aims to evaluate wether high-dose penicillin V is as effective as high-dose     amoxicillin for the treatment of non-sever community-acquired pneumonia (CAP).   "
6150|NCT03205371|"     This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study     is conducted to assess the immunogenicity and safety of a single dose of MenACYW conjugate     vaccine when administered alone and in combination with other pediatric vaccines in healthy     toddlers in South Korea, the Russian Federation, and Mexico.   "
5927|NCT03208322|"     The primary objective of the study is to determine the number of adverse events (AEs)     reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV)     and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican     Health Authority's AE surveillance system during a specified 24-month study period. The     secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV     and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance     Center (CNFV) in Mexico during a specified 24-month study period.   "
5928|NCT03208309|"     Considering that, Diacerein is on the market for 16 years being used continuously in elderly     patients with osteoarthritis without experience significant side effects, and considering the     anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal     models of type 2 diabetes treated with this medicine.      The aim of this study is to investigate the effect of Diacerein, a medication with     anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and     antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory     cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the     glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to     metformin treatment.   "
5929|NCT03208296|"     The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3     weeks in individuals with Basal Cell Nevus Syndrome (BCNS).      The secondary objectives of the study are to obtain preliminary data on the effectiveness of     ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by        1. evaluating the histological clearance of BCCs in patients with BCNS, and        2. assessing the clinical changes of BCCs after treatment with ASN-002, and        3. assessing the systemic effect of ASN-002 by determining response in non-injected lesions        4. assess the safety and clinical changes after a second cycle of ASN-002 injections   "
5930|NCT03208283|"     Colonoscopy is a sedated procedure traditionally performed using air insufflation during the     insertion phase of the procedure. Recently, the use of water method (eg, water infusion or     water exchange techniques) during the insertion phase of colonoscopy has been reported to     increase the proportion of patients in whom complete unsedated colonoscopy could be achieved,     reduce patient recovery time burdens, decrease abdominal discomfort during and after     colonoscopy, enhance cecal intubation, and increase willingness to repeat an unsedated     colonoscopy. However, there has been no study on the use of water method during the training     of primary care doctors or nurse endoscopists in flexible sigmoidoscopy for colorectal cancer     screening.      In unsedated endoscopic procedure such as FS, endoscope insertion techniques that can     potentially reduce patient discomfort and increase the rate of achieving an adequate depth of     scope insertion are desirable. Our current study aims to evaluate the impact of water method     during insertion phase of FS in the training of primary care doctors or nurse endoscopists     for colorectal cancer screening.   "
5931|NCT03208270|"     Bleeding is the most feared complication during extracorporeal membrane oxygenation (ECMO)     and is associated with high dosing of heparin. There is no consensus on antithrombin (AT)     supplementation during ECMO. However, AT is needed by heparin to properly anticoagulate. We     hypothesize that maintaining normal antithrombin levels during ECMO is associated with a less     heparin dosing and more adequate level of anticoagulation.   "
5932|NCT03208257|"     Septic shock is a common syndrome caused by the body's response to an infection. Septic shock     is responsible for 10% of all ICU admissions and 30% of ICU deaths. Use of beta blocker     medications may improve outcomes after septic shock. This pilot study evaluates protocols to     infuse the beta blocker esmolol in patients with septic shock.   "
5933|NCT03208244|"     This is a proof of concept, single center study for the donation of HCV-positive hearts to     HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of     sofosbuvir plus velpatisvir to prevent HCV transmission upon transplantation.   "
5934|NCT03208231|"     The purpose of this study is to evaluate the safety and antiviral activity of VRC01 in     HIV-1-infected infants beginning combination antiretroviral therapy (cART).   "
24628|NCT02963311|"     The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC in     participants with homozygous familial hypercholesterolemia.   "
5939|NCT03208166|"     The purpose of this study is to determine the effects of the Doctormate device, a specialized     blood pressure cuff used to perform remote limb ischemic conditioning, on cerebral blood flow     in subjects with intracranial atherosclerosis. Previous studies in patients with narrowing of     the brain arteries have shown that this device is safe to use and suggested that if this     device is inflated in both arms for 5 minutes, followed by deflation for 5 minutes and     repeated 4 times in a row every day for 6-9 months, the risk of another stroke is lowered and     the device may increase the blood flow to the brain.   "
5940|NCT03208153|"     The role of a routine invasive strategy in frail patients with non-ST-segment elevation acute     myocardial infarction is currently uncertain. We hypothesize that a routine invasive strategy     will improve outcomes. The aim of the trial is to evaluate the efficacy and safety of a     routine invasive strategy in increasing the number of days alive at home during the first     year and improving cardiovascular outcomes.   "
5941|NCT03208140|"     Assessment of the airway forms part of routine anesthetic practice. However, the predictions     referred to intubation or ventilation difficulties are usually inconclusive. In effect, the     failure rate in predicting such difficulties exceeds 60%. In this scenario it is not possible     to know whether a given patient will be difficult to intubate and ventilate. These are     referred to as non-intubate and non-ventilate cases with a high risk of severe neurological     complications and even death due to hypoxemia. According to all the clinical guides, the     solution in such cases usually involves the use of supraglottic devices that rescue     oxygenation through effective ventilation.      In the event of ventilation failure with a supraglottic device, it is currently not possible     to know whether the device is correctly positioned, unless some other instrument such as a     flexible fiberscope is used to visualize the anatomy beyond the ventilation device.      The TotalTrack is a new device with all the characteristics of a supraglottic device that     moreover includes a camera at the tip, allowing us to confirm anatomical positioning with     respect to the glottic structures. This device also allows intubation under indirect     visualization of the glottis, thus adding the possibility of definitive patient lung     isolation.      The primary objective of this study is to determine the capacity to visualize the glottic     structures through the camera of the TotalTrack device, compared with glottic visualization     afforded by indirect laryngoscopy in the same patient. The Cormack-Lehane scale and     percentage of glottic opening (POGO) are used for this purpose.      The secondary objectives comprise assessment of the ventilation, intubation and TotalTrack     device withdrawal times. The hemodynamic changes associated to both techniques during     intubation and TotalTrack device withdrawal are also evaluated. Minimum patient oxygenation     throughout the procedure is assessed. The sealing and ventilation pressures during operation     of the TotalTrack device are recorded. Likewise, an analysis is made of the number of     placement attempts, visualization improvement maneuvers, and minor complications associated     to the use of the TotalTrack device (presence of blood upon withdrawal or pharyngeal pain),     with their degree of severity.   "
5942|NCT03208127|"     This is a single center study for the donation of HCV-positive livers to HCV negative     recipient patients, with preemptive, interventional treatment to prevent HCV transmission     upon transplantation.   "
5943|NCT03208114|"     Background: Although exclusively breastfeeding is recommended up to six months, current     breastfeeding rates are still far from recommended targets. The investigators aim to     investigate the effect of the information on breast milk substitutes at discharge on     breastfeeding rates at six months of age.      Methods: A randomized controlled trial has been designed. All mother-infant pairs will be     randomized to either receive the written information of the name of a breast milk substitute     on the infant's discharge documents (group A) or not to receive it (group B). Mothers will     receive a phone interview on mode of infants' feeding at 7 days,1, 2 , 3 and 6 months after     delivery. Reasons for early discontinuation of breastfeeding according to mothers' opinion     will be also collected.      Statistical analysis:      Sample size: In order to detect a 10% difference in the discontinuation rate of exclusive     breastfeeding at six months of age between groups, at 5% significance and 80% power, a total     of 388 mother-infant pairs per group will need.      Descriptive data will be expressed as mean±SD or number of observations (percentage). With     regard to the items that were scored on a 5-point Likert scale, for the analysis, the answers     will categorize into two groups (not important and important).      Differences between groups in breastfeeding rates at each time point of the study will be     assessed by the T-test analysis. The X2 test will be used for comparisons between discrete     variables. Statistical significance is set at a = .05 level. All statistical analyses will be     performed by using SPSS (version 12, SPSS, Chicago, IL).   "
5944|NCT03208101|"     This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I     study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta     co-administered with Imovax Polio in healthy adults.   "
5945|NCT03208075|"     The investigators have conducted the study about the effects of normal diet and     low-phosphorus diet on phosphorus homeostasis in healthy subjects, now this study is designed     to explore further about the effect of high-phosphorus diet on phosphorus homeostasis.   "
5946|NCT03208062|"     Musculoskeletal disorders are an heterogeneous group of diseases that represent one of the     major causes of disability. Considering the importance of studying these pathologies, it is     necessary to develop research lines based on the availability of human biological material     from highly clinically relevant patients. The purpose of this project is therefore the     establishment of a bank of biological material (biobank) to investigate important aspects     related to the pathologies of the musculoskeletal system through subsequent bio-molecular     characterization studies.   "
5947|NCT03208049|"     The purpose of this study is to evaluate the efficacy and effectiveness of sleep restriction     (SR) and cognitive therapy (CT) in Gulf War Veterans with insomnia.      The primary hypothesis is that the efficacy of these treatments will depend upon an     individual subject's baseline characteristics. For SR we expect that baseline measures of     excessive time spent in bed may predict response and for CT we expect that baseline     measures of cognitive arousal and pain may predict response. Exploratory analyses using     signal detection techniques will systematically compare and contrast the potential usefulness     of a number of additional potential moderator measures.      Insomnia is a serious health problem in Gulf War Veterans that is often associated with     extensive prescription of sleeping medications. Although safer, even the latest sleeping     pills can lead to cognitive impairment and risk of abuse. Thus non-pharmacological     treatments for insomnia have been pursued as alternatives to medications. Cognitive Behavior     Therapy for Insomnia (CBT-I) is the term widely used to describe therapies that combine     behavioral and cognitive therapies for insomnia. The combined CBT-I approach has     well-documented efficacy. Between 2012 and 2014 over 650 VA mental health clinicians have     received extensive training in CBT-I. Although CBT-I is efficacious, the optimal target     populations for its major components has not yet been well-defined for Gulf War Veterans. We     propose to address this gap and develop tools for clinicians to identify the best treatment     for insomnia for individual Gulf War Veterans.   "
5948|NCT03208036|"     Development of interventions that can effectively target and remediate the cognitive and     functional impairment associated with schizophrenia is a treatment priority. Transcranial     direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is     capable of stimulating brain activity to facilitate learning. The primary objective of this     study is to evaluate the pairing of two therapeutic techniques, cognitive remediation and     tDCS, as a cognitively enhancing intervention. This study is designed to address four     questions. Is cognitive remediation paired with tDCS more efficacious than cognitive     remediation delivered with sham stimulation? Is it possible to predict responsiveness to the     intervention? Is intervention-induced cognitive change sustainable? Are there barriers to     implementing this intervention in clinical practice?      To examine the incremental benefit of pairing tDCS with cognitive remediation, a 110     clinically stable outpatients between the ages of 18-60 who have a diagnosis of schizophrenia     or schizoaffective disorder will be enrolled in a double-blind, double-baseline,     sham-controlled clinical trial. Participants will be randomized in a 1:1 ratio to receive     either tDCS or sham stimulation concurrent with working memory focused cognitive remediation.     Training will be offered to participants in a small group format. Training will consist of 48     sessions, with 2-3 sessions scheduled in a week. Each training session will last 2 hours. One     hour will be spent completing cognitive exercises that require working memory skills on a     computer. TDCS or sham stimulation will be offered concurrent with the first 20 minutes of     training with a StarStim neuromodulator. One mA of anodal stimulation will be applied to the     left dorsal lateral prefrontal cortex and the cathodal electrode will be placed in the     contralateral supraorbital position. Upon completion of working memory training, participants     will transition to a 30-minute discussion group. The discussion will focus on application of     cognitive skills in everyday life. Effective strategies for approaching cognitive tasks will     be described and practiced. Participant experience with aspects of the training will be     monitored with self-report measures of motivation, mood, and physical reactions. To assess     intervention-induced change, working memory, other aspects of cognition, functional capacity,     and community functioning will be assessed pre- and post-intervention. Cognitive outcomes     will be assessed with training tasks as well as tasks that are unfamiliar to participants. A     performance-based measure will be used to assess functional capacity for everyday living     skills and a self-report instrument will be used to assess community functioning. Potential     confounds such as symptom severity, medication changes, outside treatment hours, and     significant life stressors will be assessed individually every 2 weeks during the     intervention phase of the study. Sustainability of intervention-induced change will be     assessed with assessment sessions 6 weeks and 6 months post-intervention. Change in     performance during the first 12 training sessions on two working memory training tasks, a     n-back task and a complex span task, will be used to determine if early response to treatment     is predictive of post-intervention outcomes. An intent-to-treat analysis will be used to     analyze intervention-induced change. Regression analyses will be conducted to identify     predictors of treatment response.      Achieving the proposed objectives will yield important information about the efficacy,     durability, and efficiency of a novel pairing of cognitively enhancing interventions.     Findings will inform treatment development for patients with schizophrenia as well for     patients with other cognitively compromising illnesses.   "
5950|NCT03208010|"     The purpose of this study is to test a culturally tailored lifestyle intervention designed to     prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Half the participants     take part in a lifestyle program that emphasizes preparing and eating healthy     Mexican-American foods and increasing physical activity and the other half will take part in     an enhanced usual care control group.   "
5957|NCT03207919|"     This study will evaluate the potential impact of a brief musical intervention, the Lullaby     Project, in a sample of pregnant women. The study aims are:        1. To determine the potential effect of the Lullaby Project on maternal-fetal attachment.        2. To evaluate the potential impact of the Lullaby Project on maternal mental health.        3. To characterize the potential impact of the Lullaby Project on perceived maternal          stress.   "
5951|NCT03207997|"     Assessment of pulmonary fibrosis is currently based on high-resolution CT (HRCT) and     pulmonary function tests (PFT) such as forced vital capacity, (FVC) and carbon monoxide     diffusion (DLCO). These techniques allow a semi-quantitative analysis of the pulmonary     disease but are imperfect. The mains weaknesses are the lack of reproducibility, the limited     sensitivity and for CT the resulting radiation dose.      Recent advances in MRI sequences allow exploring the lung parenchyma with millimeter slice     thickness. Development of computer-assisted post-processing such as elastic registration     opens new perspectives in the functional study of the lung parenchyma, especially the     analysis of its deformation during the respiratory cycle and therefore of its elasticity.      Pulmonary involvement in scleroderma is present in 70 to 100% of patients and is the leading     cause of death. Initial assessment of pulmonary involvement and follow-up are important for     therapeutic decisions and patient prognosis. Quantitative analysis should be developed to     reliably evaluate pulmonary fibrosis and increase the reproducibility.      The purpose of our study is to evaluate the feasibility of quantifying pulmonary fibrosis by     successively performing full inspiration then full expiration volumetric MR acquisitions     using a VIBE - Volumetric Interpolated Breath-hold examination sequence. Post processing of     the 2 volumes using elastic registration is performed to evaluate pulmonary deformation in     the normal and fibrotic lung areas, hypothesizing that it would be different.   "
5952|NCT03207984|"     Subepithelial connective tissue graft (SCTG) is considered gold standard for root coverage     treatment. However, it is associated with postoperative morbidity, limited amount of donor     tissue and longer surgical time. Thus, the search for a tissue substitute for SCTG is     increasing. Currently, one of the possible autogenous soft tissue substitutes found in the     market is the Mucograft® xenogeneic matrix (MG). The results with the use of MC are very     promising, both for root coverage as well as for gain of keratinized tissue. The present     study consists of a parallel randomized clinical trial with the objective of comparing SCTG     (control group) and MG (test group) in the treatment of Miller's class I and II gingival     recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).   "
5953|NCT03207971|"     Subepithelial connective tissue graft (SCTG) is considered the gold standard treatment for     root coverage in Miller Class I and II single gingival recession. Therefore, scientific     evidence is limited for multiple gingival recessions, only with extrapolation from     single-tooth data. Depending on area and depth during the removal of the graft from palate,     connective tissue presents different anatomic characteristics, geometric shapes and     histological composition. Possibly different types of SCTGs present distinct volumetric     stability and physiological process of revascularization. This randomized, split-mouth,     double blind clinical trial aim to evaluate periodontal parameters (complete root coverage,     gingival recession depth and width, gingival thickness, width of keratinized tissue, probing     depth, clinical attachment, plaque and bleeding index) and gingival blood flow in recipient     sites, comparing sites that received SCTG from palatal area with predominance of lamina     propria and predominance of submucosa. Clinical measurements will be evaluated at baseline     and 3, 6 and 12 months after surgical procedure. Blood flow flowmetry with laser doppler     (LDF) will be analyzed at baseline and 3, 7,14 and 28 days after surgery. Participants will     be invited to answer a questionnaire of aesthetic satisfaction and symptoms of pain and     discomfort. Two experienced periodontists blind to experimental groups will be invited to     observe the clinical outcomes and answer an aesthetic questionnaire. Data analysis will be     performed by paired t-test if follow normal distribution or Wilcoxon if follow nonnormal     distribution with significance level of 5% (p <0.05).   "
5954|NCT03207958|"     Given the role of B cells in the pathophysiology of chronic graft versus host disease (GvHD),     the association between elevated BAFF levels post-transplant in abnormal B-cell homeostasis     and chronic GvHD, and the efficacy of belimumab in the inhibition of soluble human B     lymphocyte stimulator protein (BAFF) signaling, these proof-of-principle findings support the     rational for use of belimumab as prophylaxis of chronic GvHD. The investigators propose a     pilot and feasibility study to assess the safety and tolerability, as well as preliminary     efficacy, of belimumab as prophylaxis of chronic GvHD following allogeneic hematopoietic cell     transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be     well tolerated and have a favorable effect on incidence and severity of chronic GvHD.   "
5967|NCT03207789|"     The designed study follows up on the previous one by the international T-cell project (Bellei     et al,, 2012) and its purpose is to verify whether a prospective collection of data would     permit access to more accurate information permitting a better definition of prognosis and     investigation of more adequate treatment strategies for these neoplasms.      The analysis of patients distributed in all five macro regions of the country and a     comparison among them will provide a real picture of the disease in Brazil, limiting the bias     probably found in the previous projects.   "
5968|NCT03207776|"     Patients who are hospitalized at select Carolinas Healthcare System (CHS) sites with Chronic     Obstructive Pulmonary Disorder (COPD) acute exacerbation symptoms will be treated per the CHS     COPD Clinical Pathway. Patient outcomes will be followed, including but not limited to     readmission. Patients on the pathway will also have access to navigator services.   "
5969|NCT03207763|"     Microneedles can be prepared as a low-cost patch that is simple for patients to apply for     vaccine delivery targeting the many antigen-presenting cells present in the skin. Data     regarding the safety, reactogenicity, tolerability, and acceptability of a microneedle patch     in children are lacking. The goal of this study is to evaluate the safety, reactogenicity,     and acceptability of placement of a placebo microneedle patch to the skin of children.   "
5955|NCT03207945|"     Atherosclerosis in the setting of HIV infection is distinct and includes increased vascular     inflammation, worsened endothelial function, and a predominance of non-calcified plaque.     These outcomes can be assessed using specialized noninvasive imaging which strongly predict     future CV events in the general population.      PCSK9 has emerged as an important pharmacologic target for cholesterol lowering in the     general population and recent studies among individuals without HIV have shown that PCSK9     inhibitor therapy is safely tolerated and significantly reduces major CV events in the     general population.      The investigators will perform a clinical trial of PCSK9 inhibition in the setting of HIV     infection. This will be a randomized, placebo-controlled study to evaluate the effects of     PCSK9 inhibition on vascular inflammation, endothelial function, and non-calcified plaque     using a PCSK9 inhibitor called alirocumab. This study will recruit 140 treated individuals     with HIV who are aged 40 and older, with known CVD or risk factors for CVD and who have     evidence of vascular inflammation at baseline.      The primary and secondary objective of this study is to determine whether PCSK9 inhibition     can improve arterial inflammation as assessed by FDG-PET/CT and endothelial function as     assessed by flow mediated vasodilation. The investigators will correlate changes in arterial     inflammation and endothelial function with lipids and markers of inflammation and immune     activation.      The tertiary objective is to perform a pilot evaluation of the impact of PCSK9 inhibition on     non-calcified plaque as measured by coronary CT angiography. Non-calcified plaque     measurements will be correlated with changes in lipid parameters and markers of inflammation     and immune activation.   "
5956|NCT03207932|"     anatomical landmarks on the body surface were used to insert central vein catheter. However,     ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian     and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority     of one technique over the other.   "
5958|NCT03207906|"     Paronychia is inflammation of the skin surrounding the nail that leads to secondary     infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This     phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a     vehicle control.   "
5960|NCT03207880|"     Serial use of urine multi-level pregnancy tests (MLPTs) has been shown to be a reliable and     efficient strategy for excluding ongoing pregnancy after medical abortion at ≤ 63 days of     gestation. This pilot project will assess whether MLPTs can enhance the quality of remote     medical abortion services through enabling women to reliably ascertain their abortion     outcomes at home sooner than would otherwise have been the case.      safe2choose provides remote medical abortion services through the Internet (information,     counselling and access to abortion pills) in a growing number of countries worldwide.     safe2choose will collaborate with Gynuity Health Projects to pilot the utility of MLPTs for     home follow-up as part of its remote medical abortion services.   "
5961|NCT03207867|"     The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in     combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL)     and further explore schedule variations of NIR178 to optimize immune activation through     inhibition of A2aR.   "
5962|NCT03207854|"     This research trial collects and stores blood, tissue, and bone marrow specimens from     patients with cancer or blood disorders, and healthy volunteers to study the immune system in     a variety of different types of experiments, as well as associated clinical data as     appropriate, focused on understanding mechanisms of immunotherapy.   "
5963|NCT03207841|"     Individuals with spinal cord injury (SCI) are living to ages when metabolic disorders are     highly prevalent. The combination of impaired glucose tolerance and insulin resistance can     disrupt lipid metabolism and increase the risk of cardiovascular disease and diabetes, and     contribute to an accelerated aging process in the SCI population. Feasible interventions to     improve metabolic function in the chronic SCI are in great demand. Compared to pharmacologic     therapies, dietary modification is a more cost-effective treatment option for reducing the     risk of metabolic dysfunction that, surprisingly, has not been rigorously investigated in     people with SCI. Therefore, in the present study the investigators will investigate the     efficacy of an 8-week, eucaloric (a meal plan designed specifically to provide the exact     amount of calories needed to maintain a given body weight) LC-HP dietary intervention for     improving metabolic function, body composition, gut bacteria composition and quality of life     in individuals with SCI and impaired glucose tolerance or type 2 diabetes. The investigators     also aim to determine the association between changes in the composition of gut bacteria and     improvements in metabolic function and the association between improvements in metabolic     function and improvements in quality of life.   "
5964|NCT03207828|"     Chronic pain is a major health problem. It causes high economic and social costs around the     world and severely impairs the quality of life of those who suffer from it. Chronic pain and     major depression frequently co-occur. Patients with both conditions have a worse prognosis     and higher disability, and their treatment options are scarce. Behavioral activation (BA) may     be an especially useful intervention for these patients. This intervention targets mechanisms     of action that seem to be common to both disorders. In spite of this, the efficacy of this     intervention has not been yet examined in people with both conditions. Therefore, the purpose     of the present study is to examine the efficacy of BA compared to usual care among Chilean     women with fibromyalgia and mayor depression (N = 90). Women will be randomized to an     experimental arm (n = 45) who will receive usual care (UC) for fibromyalgia with comorbid     depression plus BA; and a comparison arm, who will receive only UC for fibromyalgia with     comorbid depression (n =45). Primary and secondary outcomes will be assessed before, during,     and after the intervention, as well as at a three month follow-up. The investigators expect     to find that, after treatment, the group receiving BA will experience higher statistical and     clinical significant reductions in depressive symptom severity (primary outcome), as well as     in their levels of some pain-related variables (namely pain intensity, fibromyalgia impact,     pain-related anxiety, catastrophism, and physical health symptoms severity). In addition, the     percentage of women in remission from the diagnosis of depression (as well as the percentage     of women responding to treatment) will be greater in the experimental arm than in the     comparison arm. Also, the percentage of women who show a clinically significant reduction in     pain intensity (decreases greater than two units in the pain intensity scale) will be greater     in the experimental arm than in the comparison arm. Finally, the investigators hypothesize     that the decrease observed in the pain-related variables will be mediated by the decrease     observed in depressive symptoms severity. Regarding the outcomes assessed at a three months     follow-up, the investigators expect to find that the differences found after treatment     between the two arms will be maintained at follow-up. In order to test our hypothesis,     Hierarchical Linear Models (HLM) and Cochran-Mantel-Haenszel tests will be performed. The     results of these study might contribute to facilitate the integrated treatment of     fibromyalgia and depression, and to reduce the burden on the health system due to the lack of     effective therapeutic strategies to treat these comorbidity.   "
5965|NCT03207815|"     The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo     for the treatment of the signs and symptoms of non-infectious uveitis in participants failing     treatment for active non-infectious uveitis   "
5966|NCT03207802|"     Study will collect data from the home using the CoVa Monitoring System. Data will be captured     and retrospectively analysis to determine if the data provided can alert clinician about a     patient's declining health.   "
5970|NCT03207750|"     The purpose of this study is to assess if there is any immune interference between the     Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant     vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as     compared to the currently licensed lyophilized formulation of the HRV vaccine when     co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age   "
6057|NCT03206788|"     The purpose of the study is to examine if a specific drug called losartan (Cozaar ®),     generally used to treat high blood pressure and to protect kidneys from damage in patients     suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients     with cystic fibrosis. The study will be performed at the Pulmonary Division at the University     of Miami, Cincinnati Children's and University of Alabama-Birmingham   "
5971|NCT03207737|"     The purpose of this study is to examine the effects of onsite and telehealth programs for     individuals with spinal cord injury. The primary aim of this study is to compare the     effectiveness of a blended 7-day onsite health promotion program followed by a 12-month     telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month     telehealth-only package in individuals with spinal cord injury. The investigators hypothesize     that the blended onsite and telehealth program will achieve better gains in fitness, dietary     control, body composition, and pain management scores across a one-year period in comparison     to the telehealth-only group. The secondary objective of this study is to examine changes in     psychosocial mediators between the two groups to determine if key social cognitive theory     constructs were significantly different between the two groups. The investigators hypothesize     that the blended onsite and telehealth program will achieve better improvements in these     outcomes compared to the telehealth only group.   "
5972|NCT03207724|"     This study is being conducted to examine the safety of the investigational drug, Xilonix(™),     in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil     (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a     syndrome that includes involuntary weight loss and physical deterioration that can contribute     to poor outcomes of cancer treatment. In other studies, Xilonix has increased lean body mass     in advanced cancer patients. This increase could lead to improved weight maintenance and     quality of life.   "
5973|NCT03207711|"     Type 2 diabetes mellitus (T2DM) is the most expensive chronic disease in the U.S.      Lifestyle modification is central to T2DM management, but long-term adherence to dietary     recommendations is difficult. A key challenge is the difficulty of coping with cravings for     high carbohydrate or sugar-laden foods in an environment where these foods are tempting and     widely available. One mechanism by which mindfulness may increase long-term dietary adherence     is by better equipping individuals with skills to experience food cravings and difficult     emotions without eating in response. Such approaches seek to strengthen abilities to be     non-judgmentally aware of, tolerate, and respond skillfully to food cravings and difficult     emotions without reacting impulsively or maladaptively. The investigators hypothesize that     improved ability to manage food cravings and emotional eating is a key mechanism through     which mindfulness-enhancements can improve dietary adherence. The study will test a     mindfulness-based intervention (MBI) for improving dietary adherence. Although the particular     diet employed is not the focus of this study, the study will use a diet with about 10% of     calories from carbohydrate as: (1) it induces a low level of ketone production, which will be     used as a biomarker for dietary adherence; (2) prior studies suggest it improves metabolic     parameters in T2DM, including glycemic control.   "
5974|NCT03207698|"     The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of     mandibular class II furcation defects and its comparison to PRF and access therapy alone.   "
5975|NCT03207685|"     To demonstrate safety and effectiveness of the Embrace device in identifying convulsive     seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy     monitoring unit (EMU).   "
5976|NCT03207672|"     This study is conducted to determine the maximum tolerated dose (MTD) of E7389 liposomal     formulation (E7389-LF).   "
5977|NCT03207659|"     The investigators aim to perform a prospective and randomized trial comparing the safety and     efficacy of active basket extraction of fragments and stone dusting during the RIRS.   "
5978|NCT03207646|"     This study evaluates a smartphone-based cardiac rehabilitation program in adults with     coronary artery disease. Half of patients will participate in a smartphone-based cardiac     rehabilitation program while the other half will receive standard-of-care.   "
5979|NCT03207633|"     This study aims to evaluate the therapeutic effect of low frequency rTMS over the right     DLPFC, versus right OFC versus Sham group of obsessive-compulsive disorder (OCD) patients.     Sixty patients will be recruited from the out-patient psychiatric clinic of a university     hospital, and randomized into three equal groups. The 1st group will receive 10 sessions of     low frequency rTMS targeting right DLPFC by means of a butterfly coil, 120% RMT, 1 Hz, 3     trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool.     The 2nd group will receive 10 sessions of low-frequency rTMS over the right orbitofrontal     cortex (OFC), the international 10-20 EEG system will be used to position the coil over the     right OFC, at the right frontopolar 2 (Fp2) electrode site, using the following parameters:     120% motor threshold, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train     interval allowing the coil to cool. The 3rd group will receive sham stimulations with the     same pulse delivery as the other groups but with the coil placed perpendicular to the scalp.      The resting motor threshold (RMT) and cortical silent period (CSP) at different intensities     from 110 % to 150 % will be measured before and after the end of sessions. All assessments     like (Y-BOCS), (HAM-A), Beck Depression Inventory, (CGI-S), (MoCA) will be performed before     and after end of the sessions and 3 months later.   "
5980|NCT03207620|"     Smoking occurs frequently in patients with asthma. Recent surveys on smoking prevalence     report 21-26% current smokers in populations of patients with asthma. Detrimental effects of     active smoking in asthma include worse asthma control, an impaired response to     corticosteroids and accelerated lung function decline.   "
5981|NCT03207607|"     The purpose of this study was to determine the effect of mid-morning gel snacks on subjective     appetite, glucose and insulin responses, and food intake in healthy weight young adults.   "
25745|NCT02947672|"     Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative     nausea and vomiting following Laparoscopic gynecological surgeries.   "
5987|NCT03207529|"     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     alpelisib (also called BYL719) and enzalutamide that can be given to patients with breast     cancer that is metastatic (has spread) and has come back after standard treatment or is     intolerant to standard treatment.      The goal of Part 2 of this study is to learn if the dose of alpelisib and enzalutamide found     in Part 1 can help to control the disease.      The safety of alpelisib when combined with enzalutamide will also be studied.   "
5988|NCT03207516|"     In a double-blind, randomised crossover study, two sourdough croissants (SC) or two brewer's     yeast croissants (BC) were served to 17 (9 F; Age range 18-40; BMI range 18-24 kg/m2) healthy     subjects to evaluate the effects of their ingestion on postprandial gastrointestinal     functions. Hydrogen breath test was performed to measure H2 production after SC and BC     ingestion. Gastric volume was evaluated by Magnetic Resonance(MR) Imaging to calculate     gastric emptying rate in the 3-hour interval following croissant ingestion. Palatability and     postprandial gastrointestinal symptoms and perceptions over a 4-h period after the meal were     evaluated by visual analogue scale (VAS). In addition, in the 3-hour interval, blood samples     were drawn to measure serum glucose levels. The area under the curve (AUC) was employed to     evaluate global kinetics of all parameters and the T-test was used to evaluate differences     between groups.   "
5989|NCT03207503|"     Test a model of age related changes to brain circuitry and precognitive performance as     predictors of emotion regulation ability and depressive symptoms   "
5990|NCT03207490|"     The major issue for a person who has suffered a stroke is the severe impairment affecting the     hand and the high risk to have a poor recovery associated. Innovative approaches are needed     in the next future, translating recent advances from neuro-engineering, into feasible devices     for rehabilitation care. The FP7-EU project MYOSENS aims to translate known motor control     logic from sEMG prosthetic control, to rehabilitation robotics. The target is to promote the     closing of sensory-motor loop on the basis of intention to move, as detected from residual     sEMG (i.e. Extensor Digitorum Communis, Flexor Digitorum Profundus).   "
5991|NCT03207477|"     This study aim at following a cohort of prematurely born infants at 18 months corrected age,     4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent     age (TEA) with factors associated with impaired visual maturation.     (PREMAVISION-CLinicalTrials.gov ID: NCT02890251).      In this follow-up study, prematurely born infants vision will be compared to term born     infants matched for postnatal age.   "
5992|NCT03207464|"     This study aims to use [C-11]MRB PET (positron emission tomography) imaging to look at brain     injury in patients with Multiple Sclerosis (MS) and healthy individuals. The overarching     hypothesis is that there is decreased radioligand binding to the norepinephrine transporter     in multiple sclerosis, reflecting injury to the noradrenergic system and that it plays a role     in disease pathogenesis, its clinical manifestations and severity. This strategy is targeted     to address an unmet need because currently available MRI techniques lack sensitivity and     specificity for assessing such changes in the brains of people with MS.      The specific aims of the study are:        1. To determine norepinephrine transporter binding in the brains of MS patients using          [C-11]MRB PET and compare it with age, and sex matched healthy controls.        2. To determine correlation of norepinephrine transporter binding with clinical severity          and MRI parameters in MS.        3. To determine correlation of norepinephrine transporter binding with fatigue and          cognitive impairment in MS patients.   "
5993|NCT03207451|"     This investigation will be conducted in patients 18-75 years of age with multiple coronary     artery disease risk factors (antiplatelet naïve patients) and patients with prior MI or PVD     on antiplatelet therapy. Pharmacodynamics will be assessed at multiple time points to assess     onset-, maintenance-, and offset-effect of vorapaxar on thrombin generation, platelet     reactivity, and plasma/platelet endothelial and inflammatory biomarkers. Safety assessment     will be assessed throughout the study.   "
5994|NCT03207438|"     In essence the researchers are hoping to test two separate hypotheses (described below in the     form of research questions). Therefore, the proposed analysis has been outlined according to     each hypothesis.      Hypothesis 1: Is low-dose quetiapine (50 mg/day) more effective for patients with depression     who have insomnia at treatment baseline? (Stated differently: is low-dose quetiapine 50     mg/day effective as monotherapy for patients with depression regardless of whether or not     they have insomnia at baseline?).      Hypothesis 2: Is high-dose quetiapine (150 - 300 mg/day) more effective for patients     presenting with melancholic depression at treatment baseline?   "
5995|NCT03207425|"     This is a study to characterize the pharmacokinetics as well as safety and tolerability of a     single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to     matched healthy subjects.   "
5996|NCT03207412|"     This project will investigate the safety and effectiveness of human amniotic epithelial cells     in primary ovarian insufficiency patients and provide a new cell therapy against infertility.   "
5997|NCT03207399|"     The purpose of this study is to evaluate whether treatment with Epclusa     (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C     infection is feasible, safe and effective at curing HCV.   "
6007|NCT03207269|"     Approximately 3 million Canadians have type 2 diabetes, a condition where the blood sugar     levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other     complications. Patients with type 2 diabetes are often advised to consume a snack before bed     in order to help control morning blood sugar levels. However, scientific evidence for this     dietary approach is limited and there is no data to help elucidate what the ideal bedtime     snack is. We hypothesize that a high protein, high fat snack with very little carbohydrate,     will be an effective bedtime snack for lowering morning glucose without spiking glucose     levels in the night. In this study we will determine if a bedtime snack that is high in     protein and fat but low in carbohydrate can help improve morning glucose control in people     with type 2 diabetes. This information will provide scientific evidence for the potential     health benefits of strategically-timed high protein, high fat snack consumption in people     with type 2 diabetes.   "
6008|NCT03207256|"     This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or     as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202     trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.   "
5998|NCT03207386|"     The purpose of this matched comparison, multiple baseline study is to evaluate the     effectiveness of a comprehensive youth-led sexual violence (SV) prevention program, Youth     Voices in Prevention (Youth VIP). The prevention program builds on youth-adult partnerships     among middle and high school students in Rapid City, South Dakota. Consenting students will     take part in a youth summit where they will be trained as popular opinion leaders to spread     SV prevention messages among middle and high school youth and parents. Following the summit,     youth will work in small groups focused on different aspects of evidence-based prevention     strategies including bystander intervention, social marketing messaging, parent education,     norms change, and social emotional learning. Multiple research methods will be used to     examine implementation process and cost. In addition, consenting students will take six     surveys across three years including several surveys before programming begins, and several     to document Youth VIP outcomes after prevention programming takes place. Survey data from a     demographically similar community will be used to compare changes over time among youth in     Rapid City, SD and youth a comparison city not implementing Youth VIP. All phases of the     project will be implemented with collaboration from a Research Programming Advisory Board of     community members and professionals from Rapid City, SD.   "
5999|NCT03207373|"     Patients with preexcitation are at risk for sudden cardiac death. The pathogenesis is a rapid     antegrade conduction of atrial fibrillation over the accessory pathway to the ventricle     resulting in ventricular fibrillation. Today it is possible to eliminate the conduction over     the accessory pathway by catheter intervention (radiofrequency ablation) with a low rate of     complications and a high rate of success. In clinical practice it is therefore important to     estimate the risk for sudden cardiac death in an individual patient to give an advice to the     patient and the parents about the further evaluation and therapeutic strategy. The velocity     of the conduction over the accessory pathway can be estimated by analysing the ECG during     sinus tachycardia. If the preexcitation disappears at a relatively low heart rate, the risk     for sudden death is less than in patients with persisting preexcitation at the maximal heart     rate. Compared to the gold standard i.e. measurement of the refractory period of the     accessory pathway during invasive electrophysiological study (EPS), the measurements at the     stress ECG have been reported to be a relatively poor indicator for an elevated risk which     may be explained by a high intraindividual variability of this test. This study is designed     to define the clinical relevance of the stress ECG in paediatric patients with preexcitation     (compared to the invasive electrophysiological study).      First Hypothesis:      The results of the 3 stress ECG-tests are reproducible in an individual patient.      Null hypothesis: there is no difference between the three measurements of cycle length during     stress ECG. Alternate hypothesis: the difference between the three measurements of cycle     length is > 10%.      Second Hypothesis:      There is a close correlation between the results at stress ECG and the results at the     invasive electrophysiological Intervention.   "
6000|NCT03207360|"     The proposed study seeks to develop and test a novel psychosocial pain management     intervention for patients with advanced cancer. It is hypothesized that the intervention will     demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop     a combined pain coping skills training and meaning-centered psychotherapy intervention. The     second aim is to test the intervention's feasibility and acceptability as well as preliminary     efficacy for improving primary outcomes (i.e., pain, pain interference, and meaning in life)     and secondary outcomes. Two efficacious, theory-driven interventions will be integrated to     address pain management by teaching pain coping skills with a novel emphasis on enhancing a     sense of meaning in life. Participants will be patients with advanced cancer and     moderate-to-severe pain. The study will be conducted in two phases. Phase I of the study will     be intervention development. The intervention content will be guided by theory and mentoring     from a team of leading experts in pain management and meaning-centered psychotherapy. Initial     intervention content will be further informed by interviews with patients with advanced     cancer. Content will then be refined through an iterative patient testing process. Phase II     of the study will be a single-arm pilot trial testing the intervention. The intervention will     be delivered in-person and consist of four, 45-to-60 minute therapy sessions. Study measures     will be collected at baseline (0 weeks), immediately post-intervention (5 weeks), and 4-weeks     post-intervention (9 weeks).   "
6001|NCT03207347|"     This open-label, non-randomized study will investigate the use of niraparib in patients with     tumors known to have mutations in BAP1 and other select DNA double-strand break repair     pathway genes.   "
6002|NCT03207334|"     This is an open label, single arm study of midostaurin in patients with relapsed or     refractory AML.   "
6003|NCT03207321|"     This study will investigate the association between exposure to a daily nutritional     supplement in utero and during the first three years of life and adult educational, marriage,     and labor market outcomes in India. During 1987-1990, a controlled nutrition trial offered a     daily cooked meal to pregnant women and children below the age of six years in 15     intervention villages near the city of Hyderabad in South India. No supplementation was     offered during the study in another 14 control villages. The trial and its follow up surveys     are together known as the Andhra Pradesh Children and Parents Study (APCAPS).      This protocol registration is for an analysis of the publicly available APCAPS third follow     up wave (2010-2012) data. It is not a registration of the underlying 1987-1990 nutrition     trial.   "
6004|NCT03207308|"     Despite economic growth in developing countries, Sub-Saharan Africa still faces food     insecurity malnutrition and infections. Micronutrient deficiency and infectious diseases     still remain a public health problem and have a negative impact on health and the economy.     They are both directly and indirectly responsible for children morbidity and mortality. Due     to high level of children mortality (139‰) Vitamin A Supplementation (VAS) program was     implemented in Senegal since 1999. A national representative study undertook in 2010 to have     biological data on vitamin status and infections, showed that 24.4% of children aged 1-5 y     were Vitamin A Deficiency (VAD) and 50.2% were infected. To address VAD issue, large scale     oil fortification was launched by government and private industries also fortified bouillon     cubes. Furthermore, home fortification is being initiated without evaluation of VAD control     strategies existing in the country.      In order to assess the impact of national VAD control strategies in Senegalese children, this     study was designed to measure in subsample of rural children aged 3-5 y, the current vitamin     A total body stores in relation to their infectious status.   "
6005|NCT03207295|"     Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient     symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive     heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass.     Investigators seek to determine whether nesiritide would improve the early postoperative     course after total cavo-pulmonary connection surgery in children.   "
6212|NCT03204565|"     The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy     hyaluronic acid (HA) in combination with the coronally advanced flap (CAF) for the treatment     of single gingival recession site.      The hypothesis is that HA will result in improved the clinical outcomes and will reduce the     pos-operative morbidity   "
6009|NCT03207243|"     GSK3772847, an anti-interleukin (IL)33 receptor monoclonal antibody, is a novel treatment for     asthma. This is a phase 2a study which aims to evaluate efficacy, safety, tolerability,     pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in subjects with     moderately severe asthma. The study will be conducted in 4 phases including screening, run-in     phase, treatment phase and follow-up. In treatment phase, eligible subjects will be     randomized to receive either GSK3772847 or placebo administered via intravenous (IV) route     every 4 weeks in addition to open-label background therapy of fluticasone propionate/     salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. During the treatment phase, the     background therapy will be switched to FP 500 mcg for 2 weeks and the dose of FP will be     reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. The     total duration of study will be approximately 33 weeks and approximately 148 subjects with     moderately severe asthma who are maintained on high-dose of inhaled corticosteroids/     Long-Acting Beta-2-Agonists (ICS/LABA) will be randomized.   "
6010|NCT03207230|"     Study evaluates the relationships between daily physical activity levels (PAL) and functional     capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)   "
6011|NCT03207217|"     SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational     Development Center (EDC) propose to develop a web-based training product, Suicide Prevention     Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to     more effectively manage patients who screen positive for risk of suicide in this Phase     I/Phase II fast-track application. If funded, the team will develop the Risk Assessment     module in Phase I and utilize a within group pre-post design to evaluate its feasibility.     Twenty practicing clinicians will be recruited to utilize the module and complete a pre-post     knowledge test. In Phase II, the team will develop Safety Planning, Access to Lethal Means,     and Willingness to Accept a Referral modules. The efficacy of the product to positively     influence patient outcomes will be tested with a Historically Controlled Trial (HCT)     enlisting 65 practicing clinicians across five IFH sites. All providers will be trained and     patient outcomes will be tracked for 6 months post training. This data set will be compared     to 6 months of historical data for the same provider group. Primary outcomes of this study     will measure the participants' ability in obtain improved patient outcomes related to: 1)     rate of same-day C-SSRS Screening; 2) rate of suicide being added to the problem list; 3)     rate of same-day safety planning; 4) rate of same day C-SSRS Lifeline/Recent Completion; 5)     rate of same-day Risk Assessment; 6) rate of acceptance and attendance to within-Institute     referrals for post intervention patients who are offered the referral at the first visit; 7)     and lower rates of documented suicide attempts. Ultimately, the development and successful     testing of this product would provide the US health care system a novel technology to scale     up a clinician's confidence and skill to better manage patients who identify as at-risk for     suicide. Additionally, if effective, this product will have a direct impact on patient     outcomes, a vital component to any training product that attempts to train health care     professionals. The utility and scalability of the proposed product will move health care     systems toward the goal of zero deaths from suicide consistent with the Zero suicide     approach.   "
6012|NCT03207204|"     The objective of this clinical study is to evaluate the effect of the whitening treatment     performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the     tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of     participants in relation to the technique and impact on their quality of life. After being     informed of the objectives of the study, 200 participants will be selected and randomly     divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1     session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED     (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2     sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session /     week); G6 - Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week);     G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4     sessions, 1 session/week); G8 - Hybrid technique CP HP (Violet LED + application of 30%     carbamide peroxide + violet LED) (4 sessions, 1 session/week). The color evaluation will be     performed at predetermined times (before and immediately after treatment, 14 days after     completion of bleaching and 3, 6 and 12 months after completion of bleaching), and     quantitatively evaluated by colorimetric tests (objective and subjective) and     spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after     (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality     of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction     (descriptive evaluation), will be subjected to statistical analysis to determine the     homogeneity and normality of the sample and for comparison between treatment groups,     considering a 5% significance level.   "
6013|NCT03207191|"     Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation     study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem     cell transplantation (alloHSCT).   "
6014|NCT03207178|"     Cluster of differentiation antigen 19(CD19) specifically presents in B lymphocyte cell lines     steadily,while not in most normal tissue,including pluripotent hematopoietic stem     cells.Cluster of differentiation antigen 20(CD20) presents in 90% of B-cell lymphomas.CD19     antigen is a well-established target for B-cell lymphomas treatment as well as CD20     antigen.Both CD19-targeting CAR T Cells and CD20-targeting CAR T Cells can be used as     adoptive cellular immunotherapies for B-cell lymphomas.Though two kinds of single target     treatments were proved can induce recession of B-cell lymphomas, the risk of cancer cells to     escape and tumor recurrence are still existed. There are no report about combination transfer     of two kinds of single target treatments.This research aimed emphasis on safety and     therapeutic efficacy evaluation,as well as if combination transfer can decrease recurrence     rate.   "
6015|NCT03207165|"     The investigators are interested in determining if there is a meaningful difference between     two of the most commonly used medications used to improve the pumping function of the heart     among critically ill patients admitted to the Coronary Care Unit (CCU) at the University of     Ottawa Heart Institute (UOHI). To do this, the investigators will randomly assign patients     who are felt to require use of these medications by their treating physicians to one of the     two most commonly used agents in Canada: Milrinone or Dobutamine. Each patient will be     closely monitored by their healthcare team, and their medication will be adjusted based on     each patient's clinical status. Information from blood work (e.g. kidney and liver function,     complete blood counts, and other markers of how effectively blood is circulating in the     body), assessment of end-organ function (e.g. urine output, mentation), abnormal heart     rhythms noted on monitoring and results of imaging studies (e.g. angiogram, echocardiograms.)     will be collected for analysis. All patients will be followed for the duration of their     hospital stay at UOHI.   "
6016|NCT03207152|"     This study aims to test the hypothesis that gene transcriptional changes occur within 24     hours of virus exposure in the blood and nasal mucosa, and to identify early biomarker     signatures that are predictive of higher viral shedding at the peak of disease   "
6027|NCT03207009|"     This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 15 subjects ≥12     and ≤50 years of age with transfusion-dependent β-thalassemia (TDT), who have a β0 mutation     at both alleles of the β-globin (HBB) gene (i.e. β0/β0). The study will evaluate the efficacy     and safety of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin     BB305 Drug Product.   "
6028|NCT03206996|"     Auditory hyper-reactivity affects up to 66% of children with autism spectrum disorder (ASD)     and has been linked to greater stress and anxiety for children and their families. Exposure     and Response Prevention (E/RP) is highly effective for reducing obsessive/compulsive     behaviors in children with both OCD and ASD. This study is the first to assess the     feasibility and efficacy of E/RP for auditory sensory hyper-reactivity in ASD.   "
6017|NCT03207139|"     This is an open-label single arm clinical trial, plan to enroll approximately a total of 62     evaluable subjects. According to the estimated missing rate 15%, the sample size in this     study is 73.      Inclusion criteria:      To be eligible for inclusion, each patient must fulfill all of the following criteria:        1. Age equals or more than 20 years old        2. Willing to sign the informed consent        3. Pathology-proved intermediate to high risk group prostate cancer patients (PSA > 10          ng/mL, or Gleason score 7-10, or clinical stage >T2a) OR Prior radiotherapy or          prostatectomy for prostate cancer with biochemical recurrence defined as:             -  post prostatectomy: increase in PSA of > 0.2 ng/mL in two or more consecutive blood               samples             -  post radiotherapy: PSA levels of ≥ 2 ng/mL above the post-therapy nadir        4. Life expectancy more than 3 months      Exclusion criteria:      Patient who has any of the following criteria will be excluded from the trial:        1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie          still, consciousness unclear, vital sign unstable.        2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and          allergy to medium contrast        3. Unable to give informed consent.        4. Allergy history to Ga68-PSMA ligand, significant abnormal lab data (ALT more than three          times of normal value), and high risk to conduct examination after evaluations of PI.        5. Patient had malignancy history   "
6018|NCT03207126|"     Aim: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with     suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy).      All women presenting to clinic with suspected endometrial cancer will have an internal     ultrasound. If the endometrial lining is thickened an endometrial biopsy will be performed.     This can sometimes be done in an outpatient clinic, or sometimes a hysteroscopy and biopsy is     needed (on a different day). Hysteroscopy guided biopsy has the advantage of enabling the     clinician to perform directed biopsies under vision.      Ultrasound guided biopsy is a ubiquitous procedure when used elsewhere in the body however it     is not routinely used in this context. It does have the advantage of being easily performed     on the same day as the first consultation. In this pilot study we will assess the diagnostic     ability and tolerability of ultrasound guided biopsy of women with suspected cancer, as an     alternative to hysteroscopy guided biopsy.   "
6019|NCT03207113|"     The Ned case study is a 12-month mixed methods embedded single-case study with a nested     within-group pre-post comparison of health outcomes. 400 patients, 200 caregivers, and 10     clinicians will be given access to Ned. Participants will be asked to complete study     assessments at baseline, 2 months, 6 months and 12 months. 30 semi-structured qualitative     interviews with patients (n=20) and their caregivers (n=10) post-study will also be conducted     to gain insight into their experience with the application.   "
6020|NCT03207100|"     This study evaluates the safety and efficacy of an analog-sedation protocol for patients with     mild to moderate brain injuries in intensive care unit. Patients are randomly divided into     two groups. The Analgesia-based sedation group will receive remifentanil before the addition     of a sedative(Dexmedetomidine). The conventional-based sedation group will be sedated as     usual(non-protocolized). Furthermore，patients in Analgesia-based sedation group will be     divided into two subgroups（Analgosedation + remifentanil bolus group and Analgosedation     group） depending on whether they have received an intravenous bolus of remifentanil for     procedural pain relief or not during routine clinical practice.   "
6021|NCT03207087|"     This trial is a prospective, multicenter, single-arm Objective Performance Criteria     controlled confirmatory study. It is for evaluating safety and effectiveness of the WEB     Aneurysm Embolization System when treating wide neck bifurcation aneurysms (WNBN).The study's     primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The     study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by     an independent third party core lab.   "
6022|NCT03207074|"     Aim: Determine if Rapid Evaporative Ionization Mass Spectrometry (the iKnife); can diagnose     cancer and pre-cancer from endometrial tissue biopsy samples.      Women attending a gynaecology clinic for assessment of abnormal bleeding will receive an     pelvic (internal) ultrasound as routine standard of care. If any abnormalities are detected,     a tissue sample will be needed. If women are agreeable a second tissue sample will be taken     for research. The first will be analysed by conventional means (histopathology). The second     sample with new technology called the 'iKnife'. This is a modified type of Mass spectrometry     device, that separates particles based on their mass charge ratio. The idea being that if     tissue is burnt, gas is produced, and this gas contains lots of ions that can be analysed by     the iKnife. Each type of tissue (cancer or non-cancer) will have a unique signature that the     iKnife can use to distinguish between samples. If effective it could be used in future     outpatient clinics to provide a one-stop, true point of care diagnosis.   "
6023|NCT03207061|"     Aim: Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology     with respect to myometrial invasion of endometrial cancer.      This study will assess whether 3D ultrasound is accurate at predicting myometrial invasion of     endometrial cancer. All patients will receive routine standard of care (MRI). The results of     the 3D ultrasound will be compared to the MRI report and final histology.   "
6024|NCT03207048|"     This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS)     on cognition and long-term clinical outcomes of bipolar patients.   "
6025|NCT03207035|"     We propose to compare the effects of local anaesthetic dilution on the characteristics of the     ultrasound guided axillary brachial plexus block.      Administration of 40ml lidocaine 1% with epinephrine will shorten the onset time of     ultrasound guided axillary brachial plexus block when compared to 20 mL lidocaine 2% with     epinephrine for elective upper limb surgical procedures.   "
6026|NCT03207022|"     Adjuncts to local anaesthetics for the peripheral nerve blocks such as epinephrine, clonidine     and opioids have been widely used to enhance quality, duration of anaesthesia and     postoperative analgesia. Clonidine, an α2-adrenergic agonist, when combined with local     anaesthetics in axillary brachial plexus block has shown to decrease block onset time and     prolong the duration of anaesthesia.      We propose to compare the effects of combining both adjuvants to 20 mL of lidocaine 2% on the     onset of ultrasound guided axillary brachial plexus block.   "
6029|NCT03206983|"     To evaluate the intraoperative stability, safety and overall efficacy of the Canabrava Ring     (AJL - SPAIN) when used to expand pupils with less diameter than 5 mm and pupils with     sphincter synechiae.   "
6031|NCT03206957|"     In approximately half of individuals with Down syndrome, an higher than normal number of     vessels cross the optic disc margin. Investigator hypothesize that early retinal vessel     branching occurs due to inhibition of angiogenesis by triplet overexpression of endostatin,     an angiogenesis inhibitor encoded on chromosome 21. Since angiogenesis is critical in the     development of eyes and other organs angiogenesis depended (specially kidney, brain, and     recently described lungs and heart), early branching of retinal vessels at the level of the     optic disc would also likely result in abnormal renal and other organs development in these     individuals. Investigator wish to determine whether observation of optic disc vessels may     serve as an indicator of elevated endostatin levels and other angiogenesis-dependent organs     anomalies.   "
6032|NCT03206944|"     The reducing the anti-aggregation properties of platelets significantly decreases the risk of     myocardial infarction and the total number of cardiovascular events. In patients who have     cardiovascular disease, anti-platelet therapy reduces the risk of serious vascular events.     Side effects, such as bleeding, are relatively small so the benefits of anti-platelet therapy     in secondary prevention exceed the risk of these side effects. According to guidelines for     the treatment of arterial hypertension, PTNT 2015, patients with arterial hypertension (HA)     that have a 20% or higher risk for cardiovascular events in the next 10 years, should have     ASA included in their treatment to reduce this risk. It has been proved that the use of     acetylsalicylic acid in secondary prevention reduces the risk of major cardiovascular events,     while the benefits of ASA in primary prevention have recently been debated. The benefits of     using ASA in primary prevention should always be confronted with the risk of hemorrhagic     complications of this therapy According to 2016 European Guidelines on cardiovascular disease     (CVD) prevention in clinical practice, anti-platelet therapy is not recommended in     individuals who do not suffer from CVD, due to the increased risk of major bleeding. It is     important to look for alternative anti-platelet therapy for people with cardiovascular risk     factors. Standardized tomato extract (STE) does not cause side effects and may have multiple     beneficial effects on total cardiovascular risk, primarily by inhibiting platelet     aggregation. Since its discovery in 1999, several studies and human trials with STE have been     carried out. During the last 50 years, tomato (Lycopersicon esculentum) has become a highly     consumed food. The benefits of inhibiting platelet activity through diet are currently     difficult to determine due to the lack of clear and comprehensive scientific data. It is     difficult to specify the over activity of the plaques or their proper activity. However,     there are data available that indicate the benefits of a diet containing diminishing activity     of platelets (Mediterranean diet) and lowering cardiovascular risk.The investigators want to     conduct a comparison of the less common STE with clinically recognized ASA. The aim of the     study was to compare the anti-platelet effect of STE and ASA in hypertensive patients with     high cardiovascular risk.The study highlights that STE may be an alternative, food-based     strategy to control the platelets reactivity.   "
6033|NCT03206177|"     This is a Phase 1 B feasibility trial with Galunsertib, a TGFβ inhibitor, in combination with     carboplatin/paclitaxel in patients with newly diagnosed, persistent or recurrent     carcinosarcoma of the uterus or ovary. The objective of the study is to determine whether     this drug combination is safe for this patient population and to see if it is effective in     shrinking cancers, keeping them from growing or helping patients live longer.   "
6034|NCT03206164|"     The barriers faced by people with intellectual and developmental disabilities (IDD) begin in     their mid to late 20s and often mirror the experiences of older adults (50+) living in the     U.S. While evidence for successful population-specific health promotion programs and     training, such as the 12-Week HealthMatters Program has been documented, an urgent need     exists for continuous, readily available, on-demand training in these programs. Online     training can substantially aid the widespread translation of evidence-based programs into     practice and policy. This proposal seeks to test the effectiveness of an enhanced mode of     translating the HealthMatters program into practice through the use of an on-demand     e-Learning platform (HealthMatters@24/7) for staff in community based organizations (CBOs) in     one state; thereby advancing the science of translational research. HO1. More CBOs in the     asynchronous training program will have developed Strategic Action Plans for Health and     Wellness, established Wellness Committees, and have equal or more resources and improved     culture for health promotion at 1 year compared to CBOs participating in the current live     HealthMatters TtT Workshop webinar. HO2. Staff in the asynchronous training group will have     improved levels of learner/instructor satisfaction (job productivity, job performance, job     satisfaction, organizational commitment, convenience) toward the training immediately after     completing the enhanced mode of training, HM@24/7 compared to staff trained using the current     live HealthMatters TtT Workshop webinar.   "
6035|NCT03206151|"     Drugs used against cancer work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009,     can block tumor growth in different ways. Giving combination chemotherapy together with     CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer（first-line     treatment）may improve the treatment efficacy. However, it is not yet known whether giving     combination chemotherapy together with CMAB009 is more effective than combination     chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in     combination with a standard and effective chemotherapy FOLFIRI（5-Fluorouracil /Folinic acid     plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting,     compared to the same chemotherapy alone.   "
6036|NCT03206138|"     This is a study to investigate the safety and efficacy of GX-188E administered IM plus local     administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial     neoplasia (CIN) 3.   "
6213|NCT03204552|"     To determine the effect of diet and lifestyle, particularly vegetarian diets on chronic     degenerative disease outcomes in a cohort of Taiwanese Buddhists participants   "
32098|NCT02865629|"     N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar     disorder: a functional connectivity study   "
6039|NCT03206099|"     Background:      Genetic testing called sequencing helps researchers look at DNA. Genes are made of DNA and     are the instructions for our bodies to function. We all have thousands of genes. DNA variants     are differences in genes between two people. We all have lots of variants. Most are harmless     and some cause differences like blue or brown eyes. A few variants can cause health problems.      Objective:      To understand the genetics of immune disorders.      Eligibility:      People ages 0 99 who are have a disease under investigation by another NIAID study that they     are enrolled in      Relatives of those people      Design:      Participants will give a sample by one of several means.      Blood drawn by needle, or      Saliva spit into a tube, or      A couple of hairs plucked from the head, or      A fingernail clipping.      Researchers will study the genes from the samples. They will tell participants if they find     results that relate to:      The participant s (or family s) immune disorder      Serious treatable diseases (like inherited cancer or heart disease)      Some uncertain clinical results      Researchers will not routinely tell participants about results that relate to normal variants     or disorders that can t be treated.      The samples and data will be saved for future research.      Personal data will be kept as private as possible.      If future studies need new information, participants may be contacted.   "
6042|NCT03206047|"     This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when     given together with guadecitabine and CDX-1401 vaccine and to see how well they work in     treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come     back. Monoclonal antibodies, such as atezolizumab, may block tumor growth in different ways     by targeting certain cells. CDX-1401 vaccine may enhance the expression of the genes encoding     tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T     cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor     cells may help the body build an effective immune response to kill tumor cells. Giving     atezolizumab, guadecitabine, and CDX-1401 vaccine may work better in treating patients with     ovarian, fallopian tube, or primary peritoneal cancer.   "
6058|NCT03206775|"     This is a remote observational study in which participants will complete cognitive     assessments developed by Posit Science. Participants will be healthy controls aged 18-65 with     reliable internet access and a device that they can use to access the assessments, such as a     laptop or iPad. Participants will complete up to 6 Posit Science assessments in different     domains of cognition, which should last approximately 30 minutes.   "
6043|NCT03206034|"     Impairments in higher level cognitive processing, such as new learning and memory, are common     in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including     occupational and social functioning. Despite this, few studies have attempted to remediate     these cognitive deficits in order to improve everyday functioning. While not applied in     traditional rehabilitation protocols as of yet, many techniques from cognitive psychology     significantly improve learning and memory in healthy persons. These techniques include the     generation effect (GE), the spacing effect (SE), and the testing effect (TE). These     techniques have recently been incorporated into an 8-session treatment protocol, Stylistic     Memory Enhancement (SME), designed to teach participants about each of the techniques, train     them on how to apply the techniques in daily life and practice their application to daily     life memory demanding situations. The protocol includes teaching participants how to     restructure a memory demanding situation in order to make optimal use of self-generation,     spaced learning and self-testing. The objective of the study is to test the efficacy of the     SME in an MS population.   "
6044|NCT03206021|"     Many pediatric brain and solid tumors have altered epigenetic landscapes, and altered DNA     methylation. As such this study is a Phase I/Ib study of combined 5'Azacitidine with an     escalating dose of carboplatin for all recurrent/refractory pediatric brain and solid tumors.     The phase I component will establish with maximum tolerated dose of carboplatin with     azacytidine. An expansion cohort will be recruited of up to 30 patients will follow     consisting of 20 recurrent posterior fossa ependymoma and 10 recurrent supratentorial     ependymoma.   "
6045|NCT03206008|"     Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient     surgery case   "
6046|NCT03206931|"     LOXO-195 expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene     fusion who are ineligible for an ongoing LOXO-195 clinical trial or have other considerations     that prevent access to LOXO-195 through an existing clinical trial. Expanded access is     intended to treat individual patients with different types of cancers, including blood     cancers, with a NTRK gene fusion who have previously received TRK inhibitor therapy   "
6047|NCT03206918|"     This is a single-arm, open-label, multi-center Phase 2 study in subjects with histologically     documented CLL/SLL who have relapsed after ≥ 1 prior treatment regimen(s). The study is     composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.   "
6048|NCT03206905|"     The purpose of this study is to compare the effect of endoscopic sleeve gastroplasty (ESG)     with diet and exercise, to diet and exercise alone, to see which is better in weight loss     reduction. We will also compare the effects of ESG to diet and exercise comorbidities such as     diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.   "
6049|NCT03206892|"     laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for     polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards     successful surgical procedure with less side effects   "
6050|NCT03206879|"     Norwegian hospitals are struggling to control spread of extended-spectrum beta-lactamase     producing Enterobacteriaceae (ESBL-E) in health care settings. Strict screening and isolation     criteria are enforced in hospital, and patients previously infected by ESBL-E are regarded as     possible ESBL-E carriers indefinitely. This observational multi-centre cross-sectional study     aims to estimate the duration of fecal ESBL-E carriage and to assess the risk of ESBL-E     resurgence during hospital stay for patients previously infected by ESBL-E. Through better     knowledge of these risk factors, infection control procedures may be better tailored to rhe     individual patient.   "
6051|NCT03206866|"     Although the diagnosis and therapy of HCC have being improved, the poor prognosis still     remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it     is important to detect the protein biomarkers which are associated with HCC tumor progression     and may be useful as potential diagnosis or therapeutic targets.      SMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identiﬁed     from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular     carcinoma associated antigens [4]      Serum antibody response to SMP30 in various patients using the methods of Western-blot and     ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in     the one with alpha-fetoprotein (AFP) negative   "
6052|NCT03206853|"     To evaluate the clinical benefits and risks of hybrid operating techniques in management of     complex intracranial aneurysms, which could coexists with multiple risk factors.   "
6053|NCT03206840|"     Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in     the general community the underlying neurobiological mechanisms are unclear. The change in     the relationship between the self and the conscious experience that they bring about may be     crucial. This study aims to identify the neural correlates of self-consciousness in     meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy     participants combined with detailed first-person experiential accounts and behavioural tasks.     This study will provide important clues about the widely reported effects of mindfulness     meditation and hypnosis and shed light on the neural correlates of the conscious experience     of self.   "
6054|NCT03206827|"     The aim of this study is to investigate the effects of dietary plant and animal proteins on     gut metabolism and markers for colorectal cancer as well as blood protein metabolites and     markers for type 2 diabetes in healthy adults. The study participants will be stratified into     three groups with different protein composition in diets: 1) animal 70%/plant 30%; 2) animal     50%/plant 50% and 3) animal 30%/plant 70%. The participants will get part of their diet as     ready foods or raw material to promote their compliance. The participants will also get     personal advice for their diets. Blood, stool and urine samples will be collected in the     beginning and in the end of the 12 week intervention, as well as phenotype measures like BMI,     blood pressure and body composition. The participants will also fill food diary before and in     the end of the intervention.   "
6055|NCT03206814|"     The CHARGE-APP project will investigate whether an innovative management strategy of     hypertension based on the combination of usual care visits and ESH CARE App compared to     standard care, is associated with differences in outcome, including control rate of office,     home and ambulatory BP, cardiovascular and renal intermediate end points at one year, and     changes in a number of blood pressure-related variables throughout the study.   "
6059|NCT03206762|"     A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS)     followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by     DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with     claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long     (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions     irrespective of length).   "
6060|NCT03206749|"     This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study     to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.   "
6061|NCT03206736|"     The biliopancreatic diversion and duodenal switch (BPD-DS) is an accepted and published type     of bariatric surgery in the United States. The surgery involves both restriction and     malabsorption to achieve weight loss by creating a sleeve gastrectomy as well as two     intestinal connections that bypass some of the small intestine, decreasing the amount of food     that is absorbed. The BPD-DS procedure produces the most weight loss of any bariatric surgery     commonly performed but has the highest risk of malnutrition and gastrointestinal side     effects. The loop duodenal switch (L-DS) is a bariatric surgery which has been modified from     a biliopancreatic diversion and duodenal switch to maintain excellent weight loss while     possibly reducing side effects. The surgical modifications in this procedure include reducing     the number of intestinal reconnections from two to one and reducing the amount of small     intestine which is bypassed. The L-DS operation is considered experimental by the American     Society of Metabolic and Bariatric Surgery as long-term data in large numbers of patients is     not available for weight loss or side effects. The purpose of this study is to examine weight     loss and other outcomes in the L-DS operation up to 1 year after the procedure.      Patient eligibility criteria: between 19-70 years of age at enrollment, BMI ≥ 40 kg/m2, and     the subject is under consideration for surgery for obesity or metabolic disease and elects to     undergo a primary loop duodenal switch procedure or as a conversion procedure for failed,     sustained weight loss after a sleeve gastrectomy or laparoscopic adjustable gastric band     performed more than 12 months prior to time of evaluation. All subjects will undergo a     standard comprehensive bariatric surgery evaluation which includes but is not limited to     nutrition consultation, psychological evaluation, laboratory tests and supervised medical     weight loss. Once the study subjects have met all of the insurance requirements, the     bariatric clinic will submit for insurance approval for a duodenal switch operation. Once     surgery is approved, study subjects will have a standard pre-operative history and physical     visit no more than 30 days prior to surgery and will fill out a survey regarding     health-related quality of life and amount of gastrointestinal symptoms experienced (diarrhea,     constipation, bloating, etc).      This study does not change the number of visits, timing of visits, or laboratory blood draws     surgical patients would have with the bariatric surgery clinic or staff. Study subjects will     be seen in the clinic at 2 and 6 weeks, and 3, 6, 9, and 12 months per the bariatric surgery     center protocol. As part of these normally scheduled visits, weight loss and health status     will be recorded. Labs will be checked at 3, 6, and 12 months for nutritional status. A     survey to reassess health-related quality of life and gastrointestinal symptoms will be     performed at 3 months, 6 months and 12 months.   "
6062|NCT03206723|"     Two percent of all patients presenting to the Emergency Departments have complaints involving     the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause     significant discomfort. Current treatment includes a thorough evaluation of the eye followed     by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a     randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the     initial patient evaluation followed by a return visit to the Emergency Department within 36     hours for re-examination. At each visit, the patient will be assessed for the size and     location of the abrasion along with their report of pain using a visual analog scale. Data     will be recorded on a standard data collection sheet. Telephone contact will be made at 30     days to ensure resolution of abrasion and that no complications ensued.   "
6063|NCT03206710|"     In a randomized clinical trial (RCT) published in JAMA, the investigators have provided     evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the     effects of maternal smoking during pregnancy on offspring lung function and subsequent     incidence of wheeze by 48% through 1 year of age. The investigators are currently completing     a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of     pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused,     interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in     these children including the study of pulmonary function test (PFT) trajectories and     incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of     pregnant smokers randomized to vitamin C versus placebo.   "
6064|NCT03206697|"     The present study has the objective to study whether the mitochondrial DNA copy number values     that can be generated when human embryos are analyzed for chromosomal content before embryo     transfer correlates with the actual number of mitochondria as well as their energy     requirements of the human embryo.   "
6065|NCT03206684|"     A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and     safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection)     in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous     radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer   "
6072|NCT03206593|"     Current prospective cohort study is to evaluate the association between fasting lipid     profiles (including total cholesterol, low density lipoprotein-cholesterol, high density     lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and     lipoprotein(a)) and fasting plasma glucose at admission with cardiovascular disease outcomes     (including fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke,     re-hospitalization due to heart failure, revascularization by percutaneous coronary     intervention or coronary artery bypass grafting, or cardiovascular mortality) and all-cause     mortality.in patients with ischemic heart failure and left ventricular ejection fraction < 45     % evaluated by echocardiography during 12 months follow-up.   "
21905|NCT02998879|"     The main objectives of the study are to evaluate safety and efficacy of repeated treatment     with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6     years   "
6066|NCT03206671|"     The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized     trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic,     Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the     trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell     Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents.      The following primary study questions are going to be analyzed:        -  the effectiveness (event-free survival) in pediatric patients with very limited mature          B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window          without compromising survival rates.        -  the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL          (R2 stage III) randomly assigned to receive the rituximab window plus standard          chemotherapy or standard chemotherapy without the rituximab window.        -  the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+          B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4          CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus          seven doses rituximab.      Secondary study questions will address        -  additional parameters for immune reconstitution, lymphocyte subpopulations,          immunoglobulin levels, vaccination titers and infection rates        -  kinetics of immune reconstitution after treatment        -  adverse event and severe adverse event profile        -  inter-individual variability of rituximab response        -  role of different mechanisms of action of rituximab in advanced B-NHL/B-AL   "
6113|NCT03205865|"     Type 1 diabetes (T1D) affects 1.4 million people in the U.S. and its incidence has doubled     over the past 20 years. The Diabetes Autoimmunity in the Young Study (DAISY) will estimate     overall burden of T1D and other autoimmune diseases in the general population by age 30. The     study will evaluate environmental risk factors for development of islet autoimmunity and     progression to T1D.   "
33701|NCT02844673|"     To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU     (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.   "
6067|NCT03206658|"     This study was designed to evaluate the effect of spironolactone administration in the     incidence and severity of AKI in patients critically ill with invasive mechanical ventilation     (IMV) in the critical care unit.      Patients in critical care unit (CCU) are the most at risk of developing AKI. In most cases a     mechanism of ischemia/reperfusion has a central role in the development of AKI. Aldosterone     has traditionally been recognized as a mediator that maintains water and sodium homeostasis.     Nevertheless, there are enough evidence in humans and experimental models that aldosterone     might mediate detrimental effects on renal function and structure in pathophysiological     conditions. Indeed, several experimental studies from our laboratory have shown that     mineralocorticoid receptor blockade protects the kidney against ischemia/reperfusion injury.      The aim of this study is to know:      o If mineralocorticoid receptor blockade may reduce the incidence and severity of AKI in     critically patients with IMV in CCU.      You may be able to enter in this study if:        -  You are at least 18 years old.        -  You are male or female        -  You are with IMV.        -  You are in CCU.        -  Your serum K is less than 4.5 mEq/L        -  Your BP is >90/70 mmHg      You cannot enter this study if:        -  You have CKD        -  You have AKI      This study will recruit 90 patients from Instituto Nacional de Ciencias Médicas Salvador     Zubiran in México City. The study will begin in April 2017. The patients will be randomized     to one of 2 groups of treatment (Spironolactone 25 mg or placebo). All treatments looks     identical (1 capsule), will be administered through the nasogastric tube. Neither the     patients nor their doctors will be able to know or decide which group you are in. You will     receive the medication during the first five days of stay in the critical care unit.      As part of this trial, the doctors will ask your permission to get a sample urine during this     days. They will use the samples to do tests in the laboratory (different to routine tests)     that may help them to compare renal function and biomarkers of renal injury. Your     participation will end 10 days after your entry into the critical care unit. The most common     side effect of spironolactone is hyperkalemia.   "
6068|NCT03206645|"     This is an open-label Phase Ib dose-escalation study to assess MTD, safety, tolerability, and     PK of PTC596 when combined with standard paclitaxel and carboplatin for women with stage III     or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant     chemotherapy. For all cohorts, PTC596 will be given in combination with paclitaxel and     carboplatin.   "
6069|NCT03206632|"     The primary objective of this trial is to investigate the safety and tolerability of BI     690517 in healthy Chinese and Japanese male subjects following oral administration of single     doses.      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose     proportionality as well as the investigation of pharmacodynamic effects following single     rising doses of BI 690517.   "
6070|NCT03206619|"     Patients attending the smoking cessation programme at the Virgen del Rocío University     Hospital under the SoLoMo clinical trial of the SmokeFreeBrain project (EudraCT number     2016-004771-42) and provided with the SoLoMo mobile app will be observed for one year. This     mobile app which sends the patients tailored health motivational messages selected by a     health recommender system, and based on their user profile retrieved from an electronic     health record. Patients' messages feedback and interactions with the app will be analyzed and     evaluated following an observational prospective methodology to see whether patients like the     messages, and measure the patient engagement with the health recommender system.   "
6071|NCT03206606|"     Problematic: Spirometry is used to objectify the obstructive syndrome defining chronic     obstructive pulmonary disease (COPD). However, this test remains underused in the primary     care. The tools available for its interpretation are little used and the existence of several     decision algorithms can create confusion during the diagnosis.      Principal objective: To evaluate the impact of a mobile application (SPIRO©) on medical     practice (interpretation and prescription of spirometry) of family physicians and family     medicine residents working in family medicine units (FMU) in Quebec affiliated with Laval     University.      Secondary objective : To evaluate the usability of SPIRO© among family physicians and     residents in family medicine working in FMU in Quebec affiliated with Laval University.      Methods: This is a pre-post clinical trial with control group. Participants (family MD and     family medicine residents) will be recruited from the various FMU affiliated with Laval     University. Participants working in the FMU in the experimental group will be able to use the     SPIRO® mobile application to facilitate interpretation of the spirometry test results while     participants in the control group will not have access to it during the study. The basic     characteristics of the participants and various behavioral parameters based on the theory of     planned behavior concerning the interpretation and prescription of spirometry test will be     measured. Data from the control group will be collected before those in the experimental     group at the time the application is not yet available, which will minimize contamination     between groups. The data will be collected with questionnaires delivered in person to the     participants before the intervention (T0 time) and then four months later (T1 time) during     their team or research meeting. Participants will be recruited in eight of the 12 Quebec FMU     affiliated with Laval University, who will be randomly assigned to two equal groups: control     and experimental. The intervention will consist in sending the SPIRO© mobile application to     participants in the experimental group who will use it for a period of four months.   "
6082|NCT03206450|"     This research trial studies saliva, semen, and blood samples to determine effects of     chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from     osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes     fertility problems and to learn more about the long term effects.   "
6123|NCT03205735|"     An observational study of a prospective, analytical, monocentric cohort which does not modify     the patient care because the phenotyping of the dihydropyrimidine déshydrogénase DPD     (lymphocyte activity) is already carried out in routine hospital. The analysis will be based     on clinical, radiological and biological criteria.   "
6073|NCT03206580|"     Life expectancy and elderly population are increasing. Health professionals try to provide     longevity with good quality of life for this population, through the functional independence     maintenance. In this context, physical exercise has an important role, specially the strength     training. The ability to produce muscle strength is positively associated with the     functionality and independence of older people. Different types of strength training can lead     to different neuromuscular and functional gains. These types of interventions can help health     professionals to determine characteristics of training for the elderly, aiming the     maintenance of their functional independence. Thus, the purpose of this study is to determine     the effects of a concentric strength training versus a concentric-eccentric strength training     for knee flexors and extensors on structural, neuromuscular and functional parameters in     older people, as well as to investigate the effect of a detraining period. Additionally, the     investigators will try to identify which structural and neuromuscular parameters of lower     limbs are better related to the functionality.   "
6074|NCT03206567|"     NUTRAFOL® is a novel nutraceutical supplement, scientifically formulated to specifically     target the multiple underlying causes of hair loss and thinning in women. It does not contain     hormones, drugs, or industry by-products.      The purpose of this clinical research study is to evaluate the safety, efficacy and     physiological effects of NUTRAFOL® supplement compared to placebo in forty (40) female     subjects, ages 21-65 years of age with self-perceived thinning hair over the course of six     months of continued use.   "
6114|NCT03205852|"     The objective of this study was to evaluate the effect on patient treatment decision-making     if information was given based on the benefit or on the side effect in rotator cuff     disorders.   "
6115|NCT03205839|"     The acceptance and commitment therapy (ACT) model theoretically fits with treating     appearance-related anxiety in individuals with a visible difference. This study examines the     effectiveness of an acceptance-based self-help manual for this population.   "
6075|NCT03206554|"     40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of     two groups, namely group LIA (n=20), where local infiltration analgesia would be administered     intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be     administered. All patients received a standardized multimodal approach, including pregabalin,     adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with     morphine. Morphine consumption during the first 24 hours postoperatively was measured and     additionally the investigators recorded: Time of morphine first dose administration, NRS     scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours     postoperatively, complications, patient satisfaction and duration of hospitalization.   "
6076|NCT03206541|"     This is a multi-center case-control study that aims to define the association between the     exposure to an arbovirus infection and the development of a neurological syndrome in patients     from Colombia. The study makes part of the Neurovirus Emerging in the Americas Study (NEAS)     that is a collaborative effort that looks to combine the efforts of researchers, healthcare     providers and patients in Colombia to establish a comprehensive registry of the clinical,     radiological and laboratory profile of patients with new onset of neurological diseases     associated mosquito-borne viruses, known as arboviruses.   "
6077|NCT03206528|"     This is an observational, cohort-based, single-site, prospective study conducted in     accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate     the accuracy of the device's measurements/readings in comparison to a gold standard or     standard of care patient monitor.   "
6078|NCT03206515|"     Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the     management of >20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL)     which takes nephrolithotomy channel size less than or equal to 18, was first used in the     treatment of children with kidney stones in 1997, then gradually applied to adult, aims to     achieve the similar stone clearance rate as the standard channels, at the same time, reduce     the complications. At present, the use of percutaneous renal surgery in our country is more     than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function     was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence     of Evidence-based medical evidence to compare the two kinds of sheath for the safety and     effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of     the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.   "
6079|NCT03206489|"     The investigators compared advantages and disadvantages of two forms of noninvasive     respiratory support —noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal     continuous positive airway pressure (nCPAP) —as a primary mode of ventilation in preterm     twins infants with respiratory distress syndrome   "
6080|NCT03206476|"     The objective of the study was to demonstrate the efficacy of a nutritional intervention     based on the Social Cognitive Theory and the Transtheoric Model in the favorable modification     of eating habits in adolescents of secondary education.      The hypothesis was that secondary school adolescents receiving a nutritional intervention     based on Social Cognitive Theory and the Transtheoric Model presented more favorable     modifications in their eating habits than adolescents who only received nutritional     information.      A community trial was conducted with pilot testing for the validation of the study     instruments. Adolescents from the second grade of the afternoon shift of the Jalisco     Technical High School Nº46 participated in the 2015-2016 cycle.      Self-completed questionnaires evaluated socioeconomic variables, physical activity habits,     stage of change (Transtheoric Model), constructs of the Social Cognitive Theory and five     eating habits: consumption of fruits and vegetables, natural water, dairy products, sugary     drinks and processed foods ; As well as anthropometric variables.      The intervention group had twelve workshops on healthy eating habits and two sessions for     parents. The control group received three sessions of nutritional information.      All variables were measured again at the end of the intervention to evaluate results in the     short term and three months later to know results in the medium term.   "
6081|NCT03206463|"     The overarching goal of this study is to characterize the acute cognitive and     psychophysiological effects of the main psychoactive constituent of cannabis,     9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to     begin probing the mechanisms that may underlie its effects in this illness.      This study is expected to contribute to a better characterization of specific effects of THC     in individuals with BD compared to healthy controls (HC).   "
6083|NCT03206437|"     This study will evaluate the effects of Mindfulness-Based Stress Reduction (MBSR) on     physiological reactivity. This study will focus on individuals with anxiety who will     participate in an 8-week MBSR class. The investigators will test participants' reactivity to     both predictable and unpredictable stimuli before and after the class to understand the     physiological changes that may occur after to the intervention. Secondary measures include     psychometric instruments and a delay discounting task.   "
6084|NCT03206424|"     WHO and UNICEF recommend exclusive breastfeeding for six months and addition of complementary     foods (CF) at six months of age with continued breastfeeding till two years But WHO estimates     that 2 out of 5 children are stunted in low-income countries, so CF should be timely,     adequate and prepared and given in a safe manner.   "
6096|NCT03206268|"     The aim of this study is to evaluate the correlation of retinal nerve fiber layer (RNFL)     thickness measured using spectral domain optical coherence tomography (SD-OCT) and scanning     laser polarimetry (SLP) in uveitic eyes compared to healthy eyes.      A descriptive, observational, prospective, consecutive, cross-sectional, controlled,     mono-center case series was conducted from May to October 2015. Clinical characteristics,     best-corrected visual acuity, intra-ocular pressure, RNFL thickness measurement with SD-OCT     and SLP using GDx variable corneal compensation (GDx VCC) were performed for each patient. An     evaluation of anterior chamber inflammation with laser flare cell meter was also carried out.     Correlations between SD-OCT and GDx VCC RNFL measurement were evaluated by linear regression     analysis.   "
6085|NCT03206411|"     -  Addiction to drugs and alcohol is increasingly becoming a worldwide trend that is          prevalent in both rich and poor countries . Substance abuse shows a significant warming          to the health, social and economic build of families, communities and nations. Extent of          worldwide psychoactive substance use is estimated at 2 billion alcohol users and 185          million drug users .        -  Substance abuse (including alcohol and drugs) is an important risk factor for poor          health globally due to their intoxicating effects or their toxic effects on organs and          tissues that lead to the development of diseases, injuries and other health conditions        -  Drug abuse is associated with the increased risk of cardiovascular diseases. A study on          the need for hospitalization in approximately 4800 drug users found that 223 of these          were admitted to hospital due to cardiovascular diseases .        -  The majority of abused substances or their metabolites are excreted through the kidneys          and renal complications of drug abuse are very common .The involvement of the kidney due          to drug abuse is either attributed to their elimination through the kidney, or a direct          nephrotoxic effect. The damage may be acute and reversible, or chronic and can leads to          end stage renal failure .        -  Addiction is responsible for different types of liver diseases including fatty liver,          hepatitis and liver failure. . Intravenous drug addiction by sharing of contaminated          needle is very important risk factor for the development of liver diseases, particularly          hepatitis B and hepatitis C. Globally, 90% of new hepatitis C infections are attributed          to drug injection . In the long run, substance abuse has negative effects on sexual          functions and leads to the onset of sexual disorders. .        -  Long term use of alcohol was reported to inhibit of hypothalamic-pituitary-adrenal axis          and reduces the release of gonadotropins from the pituitary . Morphine administration          suppresses LH release and reduces the levels of testosterone, which affects testicular          function.   "
6086|NCT03206398|"     Non-operative treatment of pelvic fractures is possible. Immobilisation implies different     adjustment processes. Patients with pelvic ring fractures and partial weight bearing have to     obtain theses. The aim of this pilot study was to prove the additional effect of the     anti-gravity treadmill in patients with non-operatively treated pelvic fractures.   "
6087|NCT03206385|"     The present register has been designed to confirm the hypothesis that while using high     quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam     stereotactic boost component it would be possible to maintain the late severe toxicity rates     under the 5 % level in situations where brachytherapy could not be proposed as a boost.   "
6088|NCT03206372|"     Young women have an increased risk of venous thromboembolism (VTE) during hormonale exposure     (estrogen-containing pill or pregnancy). In order to detect women at higher risk of VTE     during hormonal exposure, thrombophilia testing is often performed in order to adapt     contraception methods and/or to increases thromboprophylaxy during pregnancy. However, such     practice is probably not accurate nor discriminent. Indeed, there are evidence that the     impact of the familial history of VTE might be stronger than that of detectable inherited     thrombophilia.      The FIT-H study is a cross-sectional study comparing the prevalence of previous venous     thromboembolism in first-degree relatives of women (propositi) who had a first episode of     venous thromboembolism in association with hormonal exposure with the prevalence of previous     venous thromboembolism in first-degree relatives of women who did not have venous     thromboembolism during a similar hormonal exposure.      The primary objective is to determine the association between the presence or the absence of     VTE in young women during hormonal exposure and the presence or the absence of a previous     episode of VTE in their first-degree relatives. Secondary objective is to determine the     impact of associated inherited thrombophilia on the risk of VTE in first-degree relatives.   "
6089|NCT03206359|"     GADD34 (Growth Arrest and DNA Damage inducible-protein) is a regulatory subunit of PP1     (phosphatase 1) phosphatase which dephosphorylates eIF2alpha (eucaryotic initiation factor 2     alpha subunit), representing a negative feedback loop of the unfolded protein response (UPR).     Moreover, GADD34 is necessary for type I interferon (IFN) production in response to viral     infection in murine models. We investigate here the expression of GADD34 in systemic lupus     erythematosus (SLE), in which type I IFN has an important pathogenic role.      We report a case-control study on GADD34 gene expression in PBMC (peripheral blood     mononuclear cells) of SLE patients (n=60) and age- and sex-matched healthy controls (n=30).     The level of GADD34 gene expression, as well as of type-I IFN response genes in PBMC is     measured by quantitative PCR.   "
6090|NCT03206346|"     The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective     and safe in the treatment of influenza and other acute respiratory viral infections in 13-17     years old patients.   "
6091|NCT03206333|"     The aim of the BRAGATSTON study is to provide a low cost tool for measuring CAC in breast     cancer patients, thereby identifying patients at increased risk of CVD. Breast cancer     patients and doctors can act upon this, by adapting the treatment and/or by adopting     cardioprotective interventions. Hereby, the burden of CVD in breast cancer survivors can be     reduced and better overall survival rates can be achieved.   "
6092|NCT03206320|"     Skin infiltration with local anesthetic is commonly used to decrease patient discomfort     during peripheral nerve blocks. Topically applied local anesthetic gel might provide     analgesia while eliminating the need for additional injections. The primary objective of this     study was a noninferiority comparison between the analgesia achieved with topical gel with     that of skin infiltration for pain upon needle insertion and injection during administration     of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.   "
6093|NCT03206307|"     Can professional performance and the probability of returning to work up to three years after     medical rehabilitation be predicted by spiroergometric data (or performance of the     cardiovascular system) together with psychological factors (motivation, self-efficacy) as     well as physical activity, and their interaction? How are work related and health related     factors associated with the The following variables: workload, work satisfaction, personal     assessment of the professional future and psychological stress?   "
6094|NCT03206294|"     The coverage of the diabetes is a multidisciplinary care, with practitioners'     implication(hospital and liberal), and other medical and paramedical profession: doctor,     pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between     hospital and general medecine outside. That's why the pharmacist's presence during the     hospitalization seems to be a good alternative to make the link between hospital and the     outside pharmacist where patient take his treatment.      Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge.      By this conciliation the aim of the study is to show and quantify the impact of pharmacist     presence on therapeutic target .   "
6095|NCT03206281|"     To investigate the difference of clinical VS sonographic fetal weight estimation of tall     women stature (above 10t percentile)   "
6097|NCT03206255|"     The primary objective of this study is to evaluate the immuno-persistence (type specific IgG     antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young     healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).   "
6098|NCT03206242|"     Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location.     Patients with advanced stage of the disease need extensive tumor excision with neck     dissection. Secondary reconstructive surgeries using free flap could improve the     postoperative function or appearance of cancer survivors. Advanced treatments make survival     rates increased. Effects of treatment for oral cancer develop shoulder dysfunction, speech,     mastication, donor site morbidity and psychological issues. Physical therapy may have     benefits for temporomandibular joint function, shoulder pain relief, muscle performance, and     oral structures coordination. Return to work in the number of cancer survivors is a realistic     outcome. Rehabilitation effects on functional restorations and quality of life for head and     neck survivors are needed for further studied.      The purpose of this project is to explore the rehabilitation effects following head and neck     reconstructive survivors. The investigators measure temporomandibular joint function,     shoulder function, pain monthly. Physical functions, self-reported quality of life, and the     status of return to work are measured 3 and 6 months after surgery. This prospective study     could help to predict the rehabilitation outcomes and benefits.   "
6099|NCT03206229|"     This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way,     crossover study comparing the Test (T) and Reference (R) products following subcutaneous     administration. Subjects will be randomly assigned to one of two treatments sequences (TR or     RT).      All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol     requirements and procedures will be followed within each group.   "
6100|NCT03206216|"     This clinical trial studies how well Diode laser fiber type selective stimulator works in     predicting pain development in patients with ovarian cancer who are receiving chemotherapy.     Stimulating of the pain nerve fibers in your skin with an investigational device using laser     light stimulation may help to predict whether a patient will develop painful peripheral     neuropathy, correlate with the severity of neuropathy during and after chemotherapy     treatment, and may help to explain the mechanisms of chemotherapy induced neuropathic pain.   "
6102|NCT03206190|"     Study goals        1. Prospective longitudinal data on progression in the natural course of SPG4 in          presymptomatic mutation carriers prior to clinical disease onset and in early stages of          disease        2. Biomarkers providing objective measures of disease activity   "
6103|NCT03205995|"     The purpose of this study is to evaluate the platelet count change from baseline and safety     of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study     will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody     response (ADA).   "
6104|NCT03205982|"     The overall goal of this study is to design a user-centered design app linked to a smart pill     box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled     trial. The proposed trial is scientifically significant in representing a principled and     systematic effort to test the efficacy of a smartphone intervention linked to a smart pill     box for ART adherence in PLWH in the US. Guided by a strong theoretical framework building on     our earlier user-centered design work, and integrating a real-time monitoring device, this     work has the potential to improve ART adherence in PLWH and have a sustainable public health     impact.   "
6105|NCT03205969|"     The purpose of this study is to determine whether functional games can be used to improve the     adherence and quality of life of breast cancer patients with chemotherapy.   "
6106|NCT03205956|"     The Measuring Parkinson's Disease Progression study aims to use MRI scans and a controlled     dose of levodopa to find a biomarker (objective measurement) of Parkinson's disease (PD).     Biomarkers would help determine the effectiveness of therapies in slowing or stopping PD     progression, and accelerate the pace of research.   "
6107|NCT03205943|"     To collect and analyze the physiologic data of the ICON™ during dexmedetomidine (DEX)     sedation for neonatal pulmonary function testing. The ICON™ is a noninvasive physiological     monitor which uses respiratory impedance to follow systemic vascular resistance (SVR), heart     rate, cardiac index and stroke index.   "
6108|NCT03205930|"     Neoantigen （Neo）is a new targets for immune cells，that the DC neoantigen immunotherapy was     more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and     neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood，and be     loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous     T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly     re-infused.      The study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.   "
6109|NCT03205917|"     This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral     efficacy of the PGDM1400 and PGT121 mAbs for HIV prevention and therapy.   "
6110|NCT03205904|"     Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and     progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC). Until     now, there is no evidence to support the use of low glycemic index diet to improve glycemic     response in pre-diabetic and CF patients. The objective of this study is to evaluate the     glycemic improvement after nutritional orientation in patients with cystic fibrosis.   "
6111|NCT03205891|"     The goal of this clinical research study is to find the highest tolerable dose of TAK228 that     can be given in combination with brentuximab vedotin in patients with lymphoma. The safety of     this combination will also be studied.   "
6112|NCT03205878|"     Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls.      First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with     an improvement in oxygen saturation and sleep. No improvement on physical activity has been     shown.      The current study would randomize patients in a standard care group (CPAP) and an     intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with     physical activity assessment before, after 3 months and 12 years.   "
6116|NCT03205826|"     Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar     collateral ventilation during bronchoscopy. Assessing collateral ventilation is important     when you intend to treat a patient with endobronchial valves. Chartis measurement of     collateral ventilation can be performed under both conscious sedation as well as general     anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis     measurements in the literature.      Objective: In this project we want to investigate whether there is a difference in Chartis     measurement outcomes between these two methods of anesthesia: conscious sedation and general     anesthesia.      Study design: This study will be a single center observational study      Study population: The study population exists of patients with severe emphysema who undergo     collateral ventilation assessment before bronchoscopic lung volume reduction treatment with     one-way endobronchial valves.      Intervention: All patients will undergo two subsequent Chartis measurements. The first     measurement will be performed with the patient undergoing conscious sedation and the second     measurement with the patient under general anesthesia.      Main study parameters/endpoints: Our primary outcome measure is the failure rate of the     Chartis collateral ventilation measurement under general anesthesia versus conscious     sedation.   "
6117|NCT03205813|"     Spinal block with intrathecal morphine is a popular anesthetic technique in cesarean     delivery. This technique brings about good maternal and neonatal outcomes as well as provides     good postoperative pain control. Systematic review showed intrathecal morphine produced long     period of pain control up to 27 hours. However, some patients still experienced moderate to     severe pain which defined as postoperative pain score >,= 4. From our institute survey, there     were more than 50 percents of patients undergoing cesarean delivery receiving spinal block     with intrathecal morphine experienced moderate to severe pain in the first 24 hours.      The aim of the study is to determine the actual incidence and associated factors of patients     whom experienced moderate to severe pain after spinal anesthesia with intrathecal morphine     200 mcg in cesarean delivery.   "
6118|NCT03205800|"     Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears     gradually when the tooth is extracted. This bone loss often becomes a problem if a patient     wants to close the missing tooth space with orthodontic treatments (braces), or to get a     dental implant (a metal post replacing a tooth). Therefore, we would like to place small     screws at the extraction sites to preserve the alveolar bone when the teeth need to be     extracted and a patient cannot start treatments some time.      Mini-screws (small metal screws) are routinely used for regular orthodontic treatment. We     will recruit patients who require extractions of two upper small molars (maxillary premolars)     on both right and left sides. We will place one mini-screw on one side while the other side     will be untouched after teeth extractions. Both sides will be followed at 4 months and 8     months for examinations.   "
6119|NCT03205787|"     Human safety studies will be carried out to test whether red clover botanical dietary     supplements used by peri- and post-menopausal women are safe to use with Food and Drug     Administration (FDA)-approved drugs. To test this, a red clover dietary supplement     (previously tested in women at the University of Illinois at Chicago without any harmful     effects) will be given with four selected FDA-approved drugs to determine if the red clover     supplement can increase or decrease how these medications are absorbed, metabolized and     excreted by the human body. Preclinical studies predict that the red clover supplement might     affect the metabolism or break down of these probe drugs.   "
6120|NCT03205774|"     The aim of this prospective study was to assess the effect of patient positioning on the     ultrasound assessment of gastric contents.   "
6121|NCT03205761|"     This is a multicenter single-arm phase II clinical trial to evaluate the efficacy and safety     of olaparib in patients diagnosed of advanced triple negative breast cancer (TNBC) with     methylation of BRCA1 and/or BRCA2 promoters assessed in DNA from metastatic lesions and     absence of BRCA1 and 2 germline mutations.      Patients must have received at least one previous regimen in the advance disease setting and     must have at least one measurable lesion that can be accurately assessed according to RECIST     v.1.1. Potential eligible patients will be screened to assess somatic (s) BRCA promoter     methylation at an reference central laboratory. Germinal (g) BRCA mutational status will be     analyzed also centrally at Myriad GmBh laboratory unless the BRCA mutational status is     already known based on a Myriad previous report. Patients with a positive methylation status     on at least one of the two genes and lacking of known deleterious or suspected deleterious     mutations in both genes could be enrolled in the study and receive olaparib.      Blood and tumor samples collected from all screened patients could be used for the biomarker     analysis, including the assessment of germline methylation status and gene expression levels     of BRCA1/2. An early efficacy review will be performed after 12 evaluable patients are     enrolled; if at least 4 of them show tumour response, additional patients will be included to     complete a total of 34 patients.   "
6122|NCT03205748|"     Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is     most commonly observed in patients with cirrhosis and resulting portal hypertension     (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a     malignancy   "
26325|NCT02941120|"     Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in     patients with full-thickness cartilage defects in the knee joint.   "
6125|NCT03205709|"     The purpose of this study is to evaluate if systematic cognitive training can improve     cognitive performance in participants (55 and older) with memory loss. This study will     evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday     cognitive and function status, in addition to long-term changes in brain networks over an     18-month period. Although there is no distribution of medication for this study, participants     are required to have an at-home computer.   "
7192|NCT03191721|"     The aim of this study was to evaluate the effects of a dentifrice containing 0.3% triclosan     on periodontal and peri-implant parameters in patients, with or without periodontitis,     treated for peri-implantitis and that were enrolled in a maintenance phase for two years.   "
6126|NCT03205696|"     This is a strategic prospective cohort study which will measure the effects of early     intensive antiretroviral therapy (ART) on the establishment and persistence of HIV-1     reservoirs and HIV-1-specific immunity in acutely /recently HIV infected youth aged 12 to 24     years as compared to newly diagnosed youth with established infection > 6 months.     Participants with newly diagnosed acute /recent HIV-1 infection will be offered enrollment     into the study with immediate initiation of ART which is the current standard of care.   "
6127|NCT03205683|"     We hypothesize that a standard course of INF can result in significant improvement in CTS as     measured by clinical, electrodiagnostic, or ultrasound measures.   "
6128|NCT03205670|"     This study investigates safety and efficacy of surgical treatment of patients with anterior     urethral stricture using a tissue-engineered construct based on autologous buccal mucosa     cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. This     is a single arm study with no control. Success will be assessed via objective and subjective     methods; complications will be tallied in a standardized fashion. Outcomes will be measured     at five years.   "
6129|NCT03205657|"     The investigators plan to perform a retrospective review of patients with poor risk     relapsed/refractory B-NHL having received HSCT and targeted immunotherapy at the Maria Fareri     Children's Hospital between January 1, 2012 and June 1, 2015. The investigators will review     the clinical records and collect the data with de-identified medical information from our     HSCT clinical research database.   "
6130|NCT03205631|"     Prospective, randomized crossover study to compare the NFT sleep patches to sham device to     assess sleep via home sleep testing device in the home environment   "
6131|NCT03205618|"     The study will provide safety and efficacy information among patients receiving daclatasvir.     It will describe daclatasvir prescribing patterns and provide a clinical profile of patients     receiving the treatment in KSA, UAE, and Qatar.   "
6133|NCT03205592|"     This prospective observational study aims to assess whether ultrasound assessment of gastric     content may be useful for the monitoring of the gastric residual content in critically ill     patients   "
6134|NCT03205579|"     Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO     analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not     affect only physical but also emotional and quality of life.      From review literatures we found that patients' knowledge about cancer pain management is     inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer     treatments, which can cause of unfavorable pain management outcome.      Therefore, we will conduct the RCT of using pain education by video comparing to conventional     face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs     examination for testing pre-post intervention to test level of understanding of patients. The     measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that     NRS should improve more than 50% at the seven day of study.   "
6135|NCT03205566|"     This study evaluates whether a 7-day course of Raltegravir 400mg bd or Raltegravir     400mg/lamivudine 150mg bd can prevent HIV from infecting genital tissue and will relate the     level of drug in the blood to the level of drug in genital tissue and to the ability to of     HIV to infect genital tissue. As well as determining whether these regimes can provide ex     vivo protection against HIV, this study will also determine speed to provision of protection     and a 48 hour PK/PD decay profile of Raltegravir following drug cessation after attaining     steady state concentrations. The results will also inform all future HIV pre-exposure     prophylaxis studies of Raltegravir and form the basis for large scale clinical trials without     the need for tissue sampling. To date, efficacy studies assessing PrEP regimens have utilized     HIV-acquisition endpoints with the consequence being such studies are required to be large in     subject number in order to power observations. In addition the study will provide for the     first time data on HIV protection rather than just Raltegravir drug levels in tissue, and     allow assessment of the possibility of Raltegravir being used as an intermittent dosing     regimen in PrEP.   "
6136|NCT03205553|"     Gastroschisis is a clinical condition characterized by a defect in the normal development of     the abdominal wall. The defect is present to the right of the umbilicus leading to in utero     bowel evisceration and exposure to amniotic fluid. Prolonged exposure to amniotic fluid may     lead to inflammatory changes and damage to the exteriorized bowel. After birth and prior to     operation, the usual treatment consists of covering the bowel with impermeable plastic bag to     prevent additional fluid losses and bowel desiccation. Subsequent operative intervention     occurs either in the operating room or in the neonatal intensive care unit. Two surgical     options include primary closure of the abdomen or placement of a silastic silo followed by     subsequent closure several days later as a staged procedure. The main reason the abdominal     wall is not closed initially is due to fear of abdominal compartment syndrome, a condition     caused by high intra-abdominal pressures leading to respiratory and circulatory compromise.     The key points of the initial surgery involve examining the intestine for any signs of     atresia, bowel compromise, and either placement of the bowels back into the abdomen or a     spring loaded silo.   "
6137|NCT03205540|"     This study evaluates postoperative analgesic efficacy within 48 hours between epidural     analgesia and single-shot bilateral adductor canal blocks in bilateral total knee     arthroplasty. Half of participants will be received continuous epidural analgesia, while     other half of participants will be received single-shot bilateral adductor canal blocks.   "
6255|NCT03203993|"     This is a prospective, multi-center, observational study, the primary objective is to     evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and     explore ovarian cancer treatment outcomes of different BRCAm status.   "
6147|NCT03205410|"     Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and     reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in     patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled     clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way     using serum creatinine concentration (SCr) and with use of serum level of neutrophil     gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury.     Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC     after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).   "
7944|NCT03181880|"     ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the     effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination     compared to standard of care bronchodilators in chronic obstructive pulmonary disease.   "
6138|NCT03205527|"     The long-term objective of this research is to develop an efficacious training paradigm to     enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare     cost. The Centers for Disease Control and Prevention estimates the direct medical cost for     fall related injuries to be $34 billion annually. Forty percent to 70% of community-dwelling     stroke survivors experience detrimental falls each year and tend to have 1.5 to 4 times     higher risk of hip fracture than their healthy counterparts; with only less than 40% of those     individuals regaining independent mobility. Falls, thus not only affect activities of daily     living but also reduce mobility, increase risk of second stroke and mortality. Despite     potential financial and functional implications of falls in this population, health-care     personnel are limited in their ability to develop and validate interventions to reduce     fall-risk for them. Further emphasis is placed on locomotor training with focus on enhancing     paretic limb function. The project design consists of a randomized controlled trial to     examine the ability of chronic stroke survivors to acquire, generalize and retain adaptations     to slip-perturbation training for not only mitigating fall risk but also improving walking     function. It also explores translation of this paradigm to the sub-acute population. The     paradigm is novel in that it targets contributions of the paretic vs. non-paretic limbs on     fall-risk through a bilateral training paradigm that involves training the non-paretic side     first and then paretic to facilitate acquisition of fall-prevention skills on the paretic     side, which may otherwise take longer to acquire training effects. The longer-term benefits     of such perturbation training, targeting both limbs for reducing falls will be assessed not     only in the laboratory but also in real life via wearable sensors, along with improved     community walking function. The hypothesis of this study if supported by the results will     provide an evidence-supported training protocol to reduce the fall-risk not only in people     living with hemiparetic stroke but also among survivors of other acquired unilateral cortical     lesions.   "
6139|NCT03205514|"     Ten-fifteen percent of acute coronary syndromes without ST-segment elevation (NSTE-ACS) are     caused by intermediate lesions without signs of unstable plaque. In this subset of patients,     fractional flow reserve (FFR) has some drawbacks and may not be always able to predict     outcome, especially when negative (above 0.80). In this particular nique of patients,     advanced imaging techniques are suggested by International guidelines. However, it is     actually unknown how these techniques may impact treatment strategies. With the present     study, the investigators want to characterize the mechanism of disease in this particular     subset of patients through multimodality imaging (intravascular ultrasound-near infrared     spectroscopy (IVUS-NIRS), optical coherence tomography (OCT)) in order to understand the     proper treatment.   "
6140|NCT03205501|"     To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of     patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there     is a need for better endoscopic visualization and the ability for targeted biopsies. Optical     molecular imaging of neoplasia associated biomarkers could form a promising technique to     accommodate this need. It is known that the biomarker c-Met is overexpressed in dysplastic     and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target     for molecular imaging.      Edinburgh Molecular Imaging Ltd (EMI) has developed a fluorescent tracer specifically     targeting c-Met by labeling a small peptide to a fluorescent fluorophore: 'EMI-137'. The     investigators hypothesize that when EMI-137 is administered intravenously, it accumulates in     c-Met expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling     (early) cancer visualization using a newly developed fluorescent fiber-bundle. This     hypothesis will be tested in the current pilot intervention study.   "
6142|NCT03205475|"     This study will focus on examining the supports required to enable community Senior JASPER     Trainers to support the training and development of junior interventionists throughout the     province of Newfoundland and Labrador, Canada. The study will examine the training and     supports delivered by Senior Trainers to help junior interventionists provide a targeted     social communication intervention (JASPER: Joint Attention, Symbolic Play, Engagement, and     Regulation) with children with autism spectrum disorder (ASD). Children's engagement, play,     and social communication outcomes will be examined as well as the influence of junior     interventionists' intervention implementation on children's outcomes. Further, the study will     examine the supports required to help junior interventionists who demonstrate slower gains in     implementation fidelity after the first three months of standard support. Interventionists     who are slow to gain implementation fidelity will be randomized to either (a) enhanced     feedback plus peer support or (b) enhanced feedback plus intensive refresher course.   "
6143|NCT03205462|"     The current Phase I clinical trial has been developed to assess the safety and tolerability     of the Fluorothyazinone drug used as a single-dose administration and a treatment course in     healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment     of volunteers.   "
6144|NCT03205449|"     Parenting for Lifelong Health (PLH) Philippines Evaluation Study: Multisite randomised     controlled trial to compare the efficacy of a culturally-adapted parenting programme,     Masayang Pamilya, versus services as usual in the reduction of child maltreatment and     improvement of child wellbeing in low-income Filipino families with children aged two to six     years in Metro Manila (N = 120).      A previous study focused on adaptation and feasibility testing was conducted from January     2016 to February 2017. Community-based participatory approaches were used to culturally adapt     the Sinovuyo programme to a Filipino context. A formative evaluation using qualitative     in-depth interviews and focus group discussions with parents, as well as consultative     workshops with service providers and other stakeholders, examined issues regarding the needs     and concerns of Filipino parents, appropriateness of intervention components and delivery,     and other specific cultural issues in order to balance fidelity to evidence-based practices     with fit to the local context [11]. The Sinovuyo programme was then adapted into the MaPa     programme with local materials and approaches developed to fit the Philippine cultural     context based on findings from the formative evaluation.   "
23330|NCT02980250|"     The purpose of this clinical multi-center study is to determine whether different doses of     domperidone are effective in the treatment of feeding intolerance in premature infant   "
6148|NCT03205397|"     In France, during surgery, only 4% of parents are present at induction, most often for     children with disabilities with iterative interventions. Some studies have shown that the     presence of parents during induction decreases the anxiety of children, while others do not.     Their conclusions all advocate preparing parents for this presence in the operating room in     an accompanying course.   "
6151|NCT03205358|"     The purpose of the study is to evaluate the immunogenicity and safety profile of a single     dose of MenACYW conjugate vaccine when given alone compared to that of the licensed vaccine     NIMENRIX®.      Observational objectives:        -  To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present          in MenACYW conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using          baby rabbit complement (rSBA) and by serum bactericidal assay using human complement          (hSBA)        -  To evaluate the antibody responses against tetanus in subjects who received MenACYW          conjugate vaccine or NIMENRIX vaccine        -  To evaluate the safety profile of MenACYW conjugate vaccine and NIMENRIX®   "
6152|NCT03205345|"     This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the     safety and efficacy of emricasan in improving event-free survival based on a composite     clinical endpoint (where all-cause mortality, new decompensation events, and MELD score     progression are events) in subjects with decompensated NASH cirrhosis.   "
6153|NCT03205332|"     Generalized Anxiety Disorder (GAD) is a chronic condition whose hallmark feature is excessive     and uncontrollable worry (American Psychiatric Association, 2013). Theories of GAD propose     that specific cognitive biases are involved in the maintenance and etiology of chronic worry.     One cognitive bias that plays a role in worrying is abstract thinking, or the tendency to     verbalize thoughts and worries in a manner that is vague and lacking in detail. There is     evidence that training depressed people to think more concretely improves depressive symptoms     and depression-type thinking styles, and reduces emotional reactivity. Given that chronic     worry and depression have commonalities (e.g., repetitive thinking styles, difficulties with     problem-solving and attentional control, emotion dysregulation), concreteness training may     help people who struggle with chronic worry. The main goals of this proof of concept     experiment are 1) to test in individuals reporting chronic worry the effects of an active     form of concreteness training that involves imagery practice (compared to a no training     control condition) on frequency of worrying, problem solving quality, and worry-related     processes; 2) to examine the degree to which concreteness training causes improvements in     daily worry and negative affect during the 7 days of practice. The study design will provide     us with an understanding on a more macro level of the potential short-term benefits and     will at the same time allow us to see, on a more micro level, how training concreteness     affects worry and mood on a day-to-day basis during a 7-day period. The findings from this     study will inform relevant clinical literature about efficacious methods to reduce chronic     worry.   "
6154|NCT03205319|"     Indigestion or dyspepsia is highly prevalent worldwide. Often these symptoms are of benign     nature and subside without treatment, or with lifestyle interventions like dietary     modifications. Too often, gastroscopy is performed because of dyspepsia. Although this is     indicated when malignancy is suspected, in a substantial part of the cases the gastroscopy is     not indicated and will not achieve clinically relevant results. It is suspected that     gastroscopy is often used for reassurance of patients or as a 'last resort'.      Our hypothesis is that adequate education of patients can replace this need for invasive     measures. The aim of this study was therefore to reduce the volume of gastroscopies for     dyspepsia, by offering patients an e-learning containing educational material on dyspepsia.      During the trial, 400 dyspeptic patients, referred for gastroscopy by the GP, will randomly     be divided into two groups: One group will receive the e-learning instead of gastroscopy     (intervention), the other group will receive the gastroscopy (control).      After a twelve week follow-up, change in symptom severity, disease specific quality of life     and fear of disease will be compared between the two groups.   "
6155|NCT03205306|"     The purpose of the study is to systematically capture and characterize mental comorbidities     for patients with myasthenia gravis. Anxiety disorders and depression for example, can     negatively affect the quality of life and lead to e.g. unemployment and early retirement     especially in young patients.      Additionally the researchers want to find out in what way certain aspects of the disease have     an influence on the quality of life, and whether different concepts of coping with the     disease have different effects on the quality of life for patients with myasthenia gravis.      During the study, close relatives of patients will also be asked to provide input about their     current stress situation in the context of supporting their relative.      Based on the results, the investigators want to improve and supplement established treatment     concepts, to ensure a more comprehensive and individual treatment.   "
6156|NCT03205293|"     The purpose of this research is to develop, apply, and evaluate a school-based intervention     program in East Jerusalem schools, designed to increase knowledge and to improve the     attitudes and healthy behavior of schoolchildren, their teachers and their mothers' with     regard to healthy eating and physical activity habits. The study tested the hypothesis that     the impact of the entire school intervention program on students' lifestyles is mediated by     their teachers' engagement in health promotion and by their mothers' involvement in school     activity.   "
6157|NCT03205280|"     1. Background The results obtained in clinical research led to a new paradigm for the          treatment of patients affected with multiple sclerosis (MS): no evidence of disease          activity. This means having each patient monitored with high quality imaging. To this          purpose, researchers have developed segmentation algorithms for automated reading of          MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the          number and the volume of focal lesions. We have thus a powerful strategic biomarker for          the treatment of MS.           Due to the relevance of comparing over time the evolution of lesions (lesion load) and          brain atrophy, the French Society of Neuroradiology edited standardized national          recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in          order to harmonize exams for all patients all over the country. At an international          level as well, MRI have been put at the heart of the therapeutic strategy.           Therefore, we need now to create the conditions able to implement, collect and analyze          imaging data according to these recommendations.           This is the meaning of the MUSIC project, which aims to develop and assess a          standardized monitoring MRI control tool for therapeutic decision.           CADIMS is this tool. It is based on an integration of several segmentation algorithms          developed by INRIA and an image viewer developed by b<>com and included in a regional          images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2          lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous          MRI exam, in a multicenter clinical context.        2. Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing          the CADIMS tool to the expert consensus.   "
6214|NCT03204539|"     The primary goal of the INITIATE trial is to compare the clinical outcome of individualized     lot selection to random lot selection utilizing one plasma-derived von Willebrand factor     (VWF)/coagulation factor (FVIII) complex concentrate for immune tolerance induction (ITI) in     subjects with congenital Hemophilia A, FVIII activity ≤2%, and a historical high-titer     inhibitor [≥5 Bethesda Unit (BU)].   "
6158|NCT03205267|"     Bosutinib is a 2nd generation tyrosine kinase inhibitor that has shown promising results from     first up to fourth line treatment in patients with in chronic phase of chronic myelogenous     leukaemia. Most patients discontinuing the treatment with Bosutinib do so because of side     effects occuring early after starting the treatment. A step in dosing scheme could improve     these early toxicities. The aim of this study therefore is to demonstrate that temporary     lowering of the Bosutinib dose during early treatment may help to reduce or prevent side     effects while preserving efficacy.   "
6159|NCT03205254|"     The primary objective of this study is to generate preliminary data on the effects of a     short-term diet of either fast food or Mediterranean type diet on HDL and microbiota     composition and function in healthy subjects, which includes both normal weight and     overweight/obese subjects.   "
6160|NCT03205241|"     Research Plan      Eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks     of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout     between supplementation periods. During the performance trials blood, expired air and heart     rate were collected. The blood samples have been used to investigate the production of     inflammation resulting from the cycling performance test. Inflammation has been assessed     using enzyme-linked immunosorbent assay for IL-6, which is an inflammatory cytokine. Work     done from the cycling performance will be analysed to investigate whether there is a     relationship with power and inflammation and whether this is modulated by fish oil     supplementation.      Specific Aims        1. Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following          high intensity cycling.        2. Is a modulation of the inflammatory response connected to cycling performance.      Hypotheses        1. Four weeks of n3-PUFA supplementation will reduce the inflammatory response        2. A reduction in inflammation will improve cycling performance      Anticipated Outcomes      A high level of cycling performance, indicated by a high average power, will be associated     with high levels of systemic inflammation. n3-PUFA supplementation will decrease the level of     inflammation and consequently cycling performance will be improved.   "
6162|NCT03205215|"     We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post     Concussive Syndrome.   "
6163|NCT03205202|"     COSMOS-Eye is an ancillary study of the COcoa-Supplement and Multivitamins Outcomes Study     (COSMOS) that will examine the role of a daily multivitamin and cocoa supplements in the     prevention of cataract and AMD, two leading causes of visual impairment in US men and women.   "
6164|NCT03205189|"     This study evaluates the comparison of the incidence of postoperative home pain after     ambulatory surgery with general anesthesia between a group with pre-surgical prescription     delivered during anesthesia preoperative clinic and a group with postoperative prescription.   "
6165|NCT03205176|"     This is a first-time-in-man (FTIM) multicenter, dose escalation study designed to investigate     the safety, pharmacokinetics, and pharmacodynamics of AZD5153 in patients with malignant     solid tumors, including lymphomas.   "
6167|NCT03205150|"     The purpose of this study is to assess the effects of LIK066 on a variety of metabolic and     inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)   "
6168|NCT03205137|"     The primary objective of this study is to compare the medication adherence measured by PDC of     patients with FDC or double-pill combination therapy in real-world Japanese therapeutic     practice.The further objective of this study is how much influence the background of patients     to the adherence.   "
6169|NCT03205124|"     Traumatic injury to the peripheral nerves is most common in the young population with high     associated costs to the patient, as well as to society. These range from acute healthcare     cost to loss of productivity and rehabilitation. Despite major efforts in improving surgical     technique, functional outcome has not significantly improved in the past thirty years.     Irreversible denervation, atrophy of target muscles, and deranged sensation secondary to slow     or aberrant axonal outgrowth remains a significant challenge. Although pre-operative     conditioning of the injured peripheral nerve with electrical stimulation has shown promise in     animal studies, it has not been tested in humans.      In animal studies, pre-operative conditioning with electrical stimulation (ES) of the injured     peripheral nerves promoted peripheral nerve regeneration in both sensory and motor fibres. We     propose to conduct a clinical trial comparing 3 different treatments of complete digital     nerve laceration before and after surgical repair. Participants will be randomized to one of     three treatment arms: i) pre and post operative electrical stimulation, ii) pre-operative     electrical stimulation alone , or iii) control group that receives sham pre and     post-operative electrical stimulation. We will evaluate the effect of pre-operative     electrical stimulation on axonal regeneration, as well as determine whether there is an     additive effect of pre and post-operative electrical stimulation on sensory nerve axonal     regeneration.   "
6170|NCT03205111|"     The aim of this study is to photographically characterize the endometrium in patients     presenting with abnormal uterine bleeding at age group from 20 to 45 years old.      and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of     the etiology of abnormal uterine bleeding.   "
6171|NCT03205098|"     To assess the evolution of biological markers of mesenteric ischemia during ultratrail.   "
6187|NCT03204890|"     Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for     controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are     anatomically and physio-pathologically similar. Based on this, the use of this therapy is     considered to be viable for the control of PE.      Objective: To evaluate the efficacy of transcutaneous posterior tibial nerve     electrostimulation for the ejaculatory reflex.      Patients and Methods: Phase II clinical trial. Patients with a diagnosis of premature     ejaculation who are treated at the Colombia Boston Medical Group clinic will be included. The     participants will receive 3 transcutaneous posterior tibial nerve stimulation therapies per     week for 12 weeks. The IELT and the PEDT scale will be evaluated on week 6, at the end of     treatment and three months after completing the protocol.   "
6172|NCT03205085|"     Right heart failure is the main cause of morbi-mortality in patients with pulmonary     hypertension (PH), including patients of chronic thrombo-embolic pulmonary hypertension     (CTEPH) or pulmonary arterial hypertension (PAH) etiologies. Endarterectomy is an effective     treatment for patients with CTEPH to lower pulmonary pressure. Evidence of postoperative     right heart remodeling are contrasted according to the studies and determinants of right     heart failure are still unclear. Similarly, few evidence exists on right ventricular     remodeling after bilateral lung transplantation for patients with pulmonary arterial     hypertension (PAH). Recent evidence have supported the role of inflammation and immunity in     the pathophysiology of PAH . While several cytokines have been shown to predict survival ,     little is known on the implication of inflammation and immunity in postoperative Right     Ventricular failure in patients with PAH.      • The specific translational goal of this current project is to elucidate the role of immune     biomarkers in 6 months postoperative right heart adverse remodeling in patients with CTEPH or     PAH. We speculate that selected immune biomarkers (such as CXCL9, interleukin -18 or     interferon) and growth factors (such as HGF) are correlated with mid-term postoperative right     heart failure.      All consecutive adults with either CTEPH referred to our center for endarterectomy, or PAH     referred for lung transplantation, will be included, aiming for 150 CTEPH and 50 PAH. After     inclusion, patients will undergo assessment of right heart dimensions and function by cardiac     magnetic resonance imaging (MRI, including 4-Dimensions blood flow sequences) and 2D and 3D     trans-thoracic echocardiography (TTE), as well as immune panel analysis. All patients will     undergo as part of routine care right heart catheterization within a week after TTE and MRI     imaging. On the day of surgery, pulmonary pressure will be measured by right heart     catheterization monitoring (as part of routine care) in order to estimate the drop of     pressure and to adjust for the extent of endarterectomy for patients with CTEPH. TTE will     also be performed on the day of surgery if possible. At 7 days post-endarterectomy or     transplant, clinical outcomes will be collected and peripheral blood will be collected.     Patients will be prospectively follow-up for 6 months. Death, need for reintervention,     duration of vasopressor after surgery and number, duration and cause of readmission will be     recorded. At 6 months after surgery, all survivors will undergo the same biological sampling,     as well as an 4D MRI and a 2D and 3D TTE. Data of right heart catheterization at 6 months (as     part of routine care) will be collected as well.   "
6173|NCT03205072|"     A prospective, multi-center, non-randomized, observational, consecutive case series, which     will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy     Glass Digital System (DS) procedure at 5-10 centers.   "
6174|NCT03205059|"     This Phase II SBIR project is designed to address the critical public health problem of     bullying and cyberbullying among middle school age youth. The project involves developing and     testing bullying and cyberbullying prevention materials, including interactive classroom     sessions and corresponding serious games, based on the evidence-based substance abuse     prevention approach called Life Skills Training. The product has the potential to fill a gap     in the intervention tools currently available to schools that can be widely disseminated     throughout the country using existing marketing and dissemination channels and decrease the     adverse consequences of bullying and cyberbullying as well as substance abuse.   "
6175|NCT03205046|"     This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.   "
6176|NCT03205033|"     Breast cancer is the second most common cancer in the world, the most common in women,     representing the leading cause of death in Brazil. The therapeutic approach for breast cancer     includes surgery, radiotherapy, chemotherapy and endocrine therapy. Chemotherapy courses with     side effects because the cytotoxic effects affect indistinctly neoplastic cells and normal     cells. The cancer per se may promote disruption in circadian rhythm. Chemotherapy induces or     enhances desynchronization of the sleep-wake cycle, which competes with impaired memory,     mood, pain and poor quality of life. Melatonin is an attractive therapeutic option in this     context. This neurohormone also has immunomodulatory, co-analgesic and anti-depressant     properties. Additionally, the antioxidant properties of melatonin may decrease free radical     formation, reducing damage to DNA. The objective is to assess the response to melatonin as a     synchronizer of the sleep-wake rhythm, neuromodulator, and mieloprotetor genoprotetor in the     effects induced by chemotherapy in women with breast cancer.   "
6177|NCT03205020|"     The aim of the current study is to assess the accuracy of maternal serum amyloid A for     prediction of preterm labor in women with threatened preterm labor.   "
6178|NCT03205007|"     Our overarching goal is to prove the benefit of a behavior change intervention designed to     help older people overcome barriers associated with risk for inadequate nutrition, so that     they can improve their nutritional intake of fruits and vegetables, low fat dairy, whole     grains, nuts, lean meats, poultry and fish.   "
6179|NCT03204994|"     This study aims to assess the lymphatic drainage of rectal tumours by using ICG as a     fluorescent non-specific marker. As a feasibility study, it will also assess its technique     and timing along with its ability to assist in removing lymph nodes when it is clinically     indicated.   "
6180|NCT03204981|"     This study will examine the safety and efficacy of intramural needle ablation (INA) in the     treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has     been unsuccessful. We hypothesize that the increased current density and improved rates of     transmural lesion creation seen with intramural needle ablation will lead to successful     arrhythmia termination with minimal or no increased risk of complication.   "
6181|NCT03204968|"     Systemic inflammation is a potentially debilitating complication of thoracic surgeries that     can result in significant physical and economic morbidity for afflicted patients. There is     compelling evidence for the role of central nervous system in the regulation of systemic     inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers     by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the     peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis     factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory     role of systemic inflammation after lung lobectomy is unknown.   "
6182|NCT03204955|"     This pilot study will compare the two hypertonic solutions currently used for subarachnoid     hemorrhage (SAH) - related complications and to determine if the reduction of chloride load     is safer, and as efficacious as the classic hypertonic solution.   "
6183|NCT03204942|"     AIM OF THE WORK To evaluate the effectiveness and safety of Pulsed and Thermal Radiofrequency     lesion of the dorsal root ganglion (RF-DRG) on a consecutive group of patients presenting     with chronic thoracic pain due to vertebral bone metastasis.   "
6184|NCT03204929|"     Multicenter, open-label dose-escalation study   "
6185|NCT03204916|"     This research trial studies cancer care delivery in adolescent and young adult patients with     acute lymphoblastic leukemia. Surveying institutions, evaluating delivery of care at the     patient level and seeking input from healthcare providers may help doctors increase rates of     adherence to National Comprehensive Cancer Network (NCCN) treatment guidelines. It may also     improve care for adolescent and young adult patients with acute lymphoblastic leukemia.   "
6186|NCT03204903|"     Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser     acupuncture group and control group under conventional treatment with artificial tears. The     effects of laser acupuncture therapy for patients with dry eye are investigated.   "
6188|NCT03204877|"     Modern living is associated with an epidemic of type 2 diabetes mellitus (T2DM). Sleep     disturbances are strong independent risk factors for incident diabetes. Melatonin has been     implicated in regulation of circadian rhythm and sleep, but it is also ascribed     anti-oxidative properties and effects on glucose homeostasis. A potential association between     melatonin and T2DM has only been addressed in few human physiological studies, but the topic     has received renewed interest since genetic-epidemiological studies have pointed to a role     for melatonin in the development of the disease. In the current study, the investigators wish     to examine whether treatment with synthetic melatonin induces physiological changes that     affect the risk of developing type 2 diabetes. Two studies of the physiological effects of     melatonin are included in the present protocol. In study A, the investigators will examine     the acute effects of Melatonin on insulin secretion and insulin sensitivity using a Botnia     clamp and in study B the investigators will examine the potential effects of Melatonin on the     incretin response.   "
6189|NCT03204864|"     This study is a prospective, multi-center, physician-initiated study, with intra-center     control arm of patients with advanced heart failure undergoing cardiac resynchronization     therapy (CRT) with or without defibrillator therapy.      The purpose of this study is to verify whether optimizing the left ventricular lead position     at implantation with the pacing cathode corresponding to the longest RV-to-LV electrical     delay may result in a better patient outcome. The RV-to-LV electrical delay will be evaluated     with RLD value (ms). RLD is the distance between the Right Ventricular pacing marker (VP) and     the maximum peak (or the first maximum peak in case of two equally tall peaks) of the LV     bipolar deflection.   "
6190|NCT03204851|"     The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when     used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for     prescription and over the counter use in humans. Primary clinical end point of study is     percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or     until wound closure. Patient population comprises patients referred to Mission's Wound     Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100     subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous     stasis ulcer (20 patients); diabetic foot ulcer [DFU] (20 patients); pressure ulcer (20     patients); wounds of various other etiologies (40 patients).   "
6191|NCT03204838|"     This leukemia is characterized by a poor prognosis for most patients, as they have a high     relapse rate despite aggressive treatment with chemotherapy agents and allogeneic bone marrow     transplantation. It has been proposed that relapse can be attributed to a leukemic cells     population with quiescence properties that are resistant to chemotherapy, known as leukemic     stem cells (LSCs). Clinical trials shown a major LSCs percentage than diagnosis correlated     with worst prognosis or minimal residual disease with AML.      AML is most common in adults and represents about 40% of all leukemia types in American     Continent. In Mexican patients with AML age median is 32 years, lower than other     international series. Genomic and functional studies have identified two classes of     mutations, which cooperate during AML development.      Somatic mutations have been identified recently that codify for isocitrate dehydrogenase     (IDH). These genes codify key metabolic enzymes, which convert isocitrate into     α-ketoglutarate (α-KG).15-16From which IDH1 and IDH2 genes presenta high frequency of     mutations in AML and other types of tumors. IDH mutations affect mainly active site residues     (for example, IDH1 R132, IDH2 R140 or IDH2 R172), resulting in the normal enzymatic function     loss abnormally converting α-KG to 2-hydroxiglutarate (2-HG).      Oncometabolyte 2-HG may competitively inhibit multiple α-KG depending dioxygenases,     including key epigenetic regulators as histones demethylases and TET proteins. Consequently,     IDH mutations are associated with chromatin alterations including global alteration of     histones and NDA methylation. This is the reason of the need to identify such mutations of     genes (IDH1/IDH2) in patients with SMD and AML entering Hematology service of the Hospital     General de Mexico from 2017 to 2019, and determine clinical impact in prognosis and     monitoring the response to therapy, as well as prognosis and survival.   "
6192|NCT03204825|"     Peripheral Arterial disease is a common condition which causes narrowing of the arteries. The     most common symptom that patients with PAD experience is Intermittent Claudication (IC), pain     in the lower limb(s) on exertion, which is relieved by rest. IC reduces patients' quality of     life (QoL) by limiting their ability to walk and engage in daily activities. Regular exercise     and physical activity (PA) are central to the management of PAD and help to improve walking     distances and reduce the risks associated with PAD such as heart attack and stroke. However,     exercise and PA in this population is often limited due to pain. Investigators have shown     that Transcutaneous Electrical Nerve Stimulation (TENS) can help to reduce pain and increase     walking distance in patients with PAD. Investigators have also shown that educating patients     about their condition and helping them to set goals has the potential to increase PA, and     quality of life. This study will examine the feasibility of designing a definitive trial that     investigates whether TENS can improve the physical activity of patients with PAD when     delivered alone and/or alongside a patient education programme.   "
6193|NCT03204812|"     The goal of this clinical research study is to study the safety and tolerability of     durvalumab and tremelimumab when given to participants with metastatic (has spread)     castration-resistant prostate cancer.   "
6194|NCT03204799|"     Microbiota is important for immunology, hormonal and metabolic homeostasis in human and could     influence on developing diabetes and obesity. Recent studies investigates microbiota by     metagenomic sequencing, however, the composite of microbiota and its metabolic role has not     been fully determined. Metagenomics and microbiome analysis could early diagnose metabolic     disorders and suggest treatment options for metabolic diseases.      In this study, the investigators investigate the composite of microbiota and deduct basic     information for treatment models using metagenomic sequencing.   "
6195|NCT03204786|"     This purposed of this clinical trial is to investigate the effectiveness of vasopressin nasal     spray for treating symptoms associated with autism. Vasopressin is a hormone that is produced     naturally within the body and has been implicated in regulating social behaviors. It has been     proposed that administration of the hormone may also help improve social functioning in     individuals with autism.   "
6196|NCT03204773|"     Comparing the non-motor symptoms of patients with SPG4 mutations to healthy controls     (spouses, relatives or other healthy controls) by using the a number of specific     questionaires   "
6197|NCT03204760|"     The aim of this study is to compare the efficacy of a single dose of intramuscular     dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to     moderate asthma exacerbations in children and test whether this single dose of intramuscular     dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the     treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory     Assessment Measure (PRAM).   "
6198|NCT03204747|"     Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor     disorders are the most visible disability, urinary disorders are frequent, with prevalence     from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions.     The seconds are due to specific lesion in inhibitor/activator encephalic centers, or     interruption on medullary conduction. It seems to be evident that walk and urinary disorders     are link, because of similar anatomic ways and control process. Effect of bladder filling is     well known on motoneuronal excitability. The effect of bladder filling on walk stay unknown,     while medullary integration of these two functions is very close, in medullary cone.      Primary aim is to assess the effect of need to void on walk speed in multiple sclerosis with     lower urinary tract symptoms. Secondary aim is to identify clinical or urodynamic factor link     with major walk impairment when patients need to void.      Patient with multiple sclerosis over 18 years old, consulting for lower urinary tract     symptoms in a tertiary center are included.      History and treatment, high, weigh, symptoms severity by USP score, cognitive impairment by     MMSE score and last urodynamic data are recorded. Patient are asked to drink water until they     feel a strong need to void, for which they would go to urinate at home.      Walk tests are realized in a specific place, with calm and no passage. A chair is placed at     each end of the path. Toilets are just next to the hall where they realize the tests. A 10     Meters Walk Test is done during this condition, 3 times (only the intermediate 6 meters are     recorded). They can take 30 seconds of rest between each try if necessary. One Timed up and     go is done. Patient can use their habitual walking device. Speed walk asking is comfortable     for the two test.      Next, patient can urinate. 3 post void residual volume with portable echography are done, and     the higher is recorded.      Patient achieve the same walk tests after urinate, in the same order. They must use the same     walking device.      Primary outcome is mean gait recorded for 10 meters walk test.      Secondary outcome is time for timed up and go test.      Individual variability between the 3 10MWT in the two conditions will be study.      Influence of age, EDSS, severity of symptoms, MMSE, detrusor overactivity on speed impairment     will be study in secondary analysis.   "
6199|NCT03204734|"     A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine     therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after     capecitabine-base chemotherapy.   "
6200|NCT03204721|"     The main aim is to test the preventive use of extracorporeal photophoresis (ECP) against     development of graft-versus-host disease (GVHD) in patients undergoing allogeneic stem cell     transplantation for hematological malignancy.   "
6201|NCT03204708|"     patients undergoing modified radical mastectomy were divided into two groups. patients in     catheter group were placed a catheter with open technique by the surgeon in the pectoral     area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml     %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in     iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog     pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and     compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.   "
6202|NCT03204695|"     The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm     safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System     in the current medical practice setting in patients with non-valvular atrial fibrillation who     are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites     in Europe. Patients will be followed through 45 days post-procedure.   "
6203|NCT03204682|"     Endometriosis is associated with different types of pain (acute, chronic, excess nociception,     neuropathic) generated by different mechanisms in the nervous system. The rTMS could provide     significant analgesia for refractory endometriosis pain.      The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation     (rTMS) for analgesia on chronic refractory endometriosis pain.   "
6204|NCT03204669|"     Major burn patients are characterized by large exudative losses of Cu, Se and Zn. Trace     element (TE) repletion has been shown to improve clinical outcome. The study aimed to check     if our repletion protocols were achieving normalization of TE plasma concentrations of major     burn patients and if the necessity for continuous renal replacement therapy (CRRT) might     increase the needs.   "
6205|NCT03204656|"     Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological     sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are     used to predict difficulties and avoid complications for usual tracheal intubation. However,     existing indices are not adapted to selective bronchial intubations.      The aim of the study is to determine the incidence of unexpected difficult SBI using     conventional screening tests. It is a prospective descriptive epidemiological monocentric     study comparing two groups of patients (selective vs. non selective intubations).   "
6206|NCT03204643|"     Patients who present to one of the participating EDs with a telepsychiatric consult performed     will be treated and followed per the behavioral health virtual patient navigation pathway     (BH-VPN) or usual care. The BH-VPN is inclusive of several components which will all be     consistently applied to patients randomized to the intervention, as well as having access to     behavioral health trained patient navigators. These key components are often deployed     inconsistently as a part of usual care, but per the intervention, will be completed in     totality for subjects who are assigned to and participate in the BH-VPN plan.   "
6207|NCT03204630|"     A randomized double blinded controlled study including infants at the age of 1 month .     Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or     L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain     (Control group). The primary outcome of the study is the body weight gain of infants.     Secondary outcomes are incidence of infections, symptoms related with intestinal function,     and fecal microbiota   "
6208|NCT03204617|"     The AELIX-002 study aims to evaluate the safety and the immunogenicity of DNA.HTI     administered alone and as part of an heterologous prime-boost regimen in combination with     MVA.HTI in early diagnosed and treated HIV-1 positive individuals, males and females,18-50     years of age.   "
6209|NCT03204604|"     The Brain Ketone Body Challenge Imaging Study will measure how the brain uses different     fuels. To do this, radioactive compounds will be used during Positron Emission Tomography     (PET) imaging.      These compounds, called [11C]Acetoacetate (AcAc) and [18F] Fludeoxyglucose (FDG), are similar     to the sugars and fats the brain already uses for fuel. These compounds safely allow     researchers to see how the brain uses sugars and fats during PET scans.   "
6210|NCT03204591|"     Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic     drug use are common in patients with cirrhosis especially in Eastern countries.These patients     are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high     short-term mortality. And the natural history of these patients is frequently complicated by     bacterial infections, which lead to deterioration of underlying diseases. The present study     is aimed to investigate the prevalance and risk factors of bacterial infections in those     patients and its impact on in-hospital/short-term mortality.   "
6215|NCT03204526|"     Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus     to improve cognitive performance in patients with advanced Parkinson's disease. All study     participants have undergone DBS implantation surgery as part of their routine care for motor     manifestations of Parkinson's disease. In this study, a temporary low frequency period of     stimulation will be applied to determine its effects on cognition.   "
6216|NCT03204513|"     The overall goal of this research is to determine the efficacy of new powered prosthetic     devices for individuals with transfemoral amputations. The anticipation is that this will be     a high-impact technological intervention with the potential to restore significant     functionality to individuals with lower limb amputation and transform the field of lower limb     prosthetics. The objective of the proposed clinical trial is to fully evaluate the     biomechanical and energetic effects of using PKA prosthesis and quantify functional     performance and quality of life changes.   "
6217|NCT03204500|"     This is a pilot study in 40 subjects with definite ALS to evaluate the efficacy of valproate     and lithium carbonate. After a random assignation of the dual treatment vs. placebo, a     follow-up of 20 months will allow to know the clinical and functional evolution so as the     status of biomarkers under each treatment.   "
6218|NCT03204487|"     Studies have shown that ocular surface disease (OSD) is common among patients with glaucoma     with a prevalence of 50% or more. The percentage of affected patients appears to increase     with increasing number of topical anti-glaucoma products instilled. Both pre-clinical and     clinical work has indicated that the preservatives used in anti-glaucoma drops, particularly     benzalkonium chloride, are mainly responsible for this detrimental effect. As such more and     more anti-glaucoma drugs without preservatives entered the market.      To prove that switching from preserved to unpreserved antiglaucoma medication improves the     signs and symptom of OSD is, however, not easy. This is on the one hand related to the     physiological variability of these parameters over time and on the other hand to the poor     association between signs and symptoms. Recently, a new method for measuring tear film     thickness (TFT) using ultra-high resolution optical coherence tomography (OCT) has been     introduced. Using this method, it has been shown that there is a correlation between reduced     TFT and OSD symptoms. In the present study, it is hypothesized that changing patients who are     on preserved prostaglandin formulations to preservative free tafluprost may be associated     with an increase in TFT.   "
6219|NCT03204474|"     The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide     (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese     male subjects.   "
6220|NCT03204461|"     In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle     were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control     subjects.   "
6221|NCT03204448|"     The study is to evaluate the clinical performance of BioCLIA Ro60 for measuring the     autoantibody in autoimmune disease patients.   "
6222|NCT03204435|"     To evaluate the clinical benefits and risks of hybrid operating techniques in management of     intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.   "
6223|NCT03204422|"     The accurate evaluation of daily salt or sodium intake is difficult to implement in clinical     practice and large epidemiological studies. 24-h urinary sodium excretion (USE) is considered     the gold standard, but is expensive and has a high participant burden. To further explore the     association between 24-h USE and spot urines in Chinese population, it was proposed that     using collected multiple spot urine samples could be estimated for 24-h USE in Chinese     children and adults.   "
6224|NCT03204409|"     Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness     of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil.   "
6225|NCT03204396|"     Cigarette smoking is the leading preventable cause of premature death worldwide. However     smoking is a very difficult addiction to break whereby main reasons for not quitting or     relapsing after cessation are the nicotine withdrawal syndrome and post-cessational weight     gain. GLP-1 analogues are well known to stimulate insulin secretion and to reduce energy     intake and therefore body weight. Recent findings from animal and human studies suggest a     role of GLP-1 in the pathophysiology of addiction. The putative role of GLP-1 analogues in     nicotine reward regulation combined with its weight reducing effects might be of major     interest in view of novel pharmacotherapeutic options for smoking cessation.   "
6226|NCT03204370|"     Mucopolysaccharidosis IVA (MPS IVA) (or Morquio A disease) is a rare recessive autosomal     lysosomal storage disorder caused by deficiency of N-acetylgalactosamine-6-sulfatase (GALNS)     resulting in accumulation of the glycosaminoglycans (GAGs) chondroitin-6-sulfate and keratin     sulfate (KS). Patients display progressive development of skeletal and joint abnormalities     and non-skeletal features including respiratory, cardiac, sensorial and neurological     complications. Recently, a specific treatment using enzyme replacement therapy (ERT) with     recombinant human GALNS (elosulfase alfa) has become available. A multicenter double-blind     placebo-controlled phase 3 trial (176 patients, age > 5 yrs) showed significant improvement     in endurance of 22.5 m in 6 Minute Walking Test (6MWT) distance after 24 weeks of treatment     with elosulfase alfa at 2.0 mg/kg/week as compared with placebo group. In addition to ERT, a     multidisciplinary management approach is necessary for coordinating assessment and follow-up     as well as for providing individualized supportive and symptomatic care.      The clinical presentation is highly variable from one patient to another regarding age at     onset, severity, progression rate and life expectancy. Most patients are affected with the     classical phenotype characterized by short trunk dwarfism with short neck and adult height <     1 m. Atypical phenotypes with less severe extension of skeletal manifestations, adult height     > 1m, and less frequent complications in other organs have been progressively recognized.     Clinical management differs depending on the clinical presentation of the patients but     natural history of the disease is largely unknown in atypical phenotypes. Precise and     exhaustive follow-up data are needed in such patients to increase our knowledge of this     natural history and to define the best criteria to evaluate ERT efficiency.      The investigators propose a prospective clinical study focused on a unique large series of 9     adult patients (aged from 18 to 55 years) followed in a single expert center for metabolic     disorders located at the university hospital of Bordeaux, France. Eight of these patients are     affected with atypical MPS IVA characterized by less severe evolution of the disease and     heights ranging from 135 to 176 cm (the last patient height is 102 cm). Investigators aim to     increase knowledge on the natural history of the disease in adult patients with atypical MPS     IVA, treated or not with ERT, and to develop new objective and robust clinical criteria to     evaluate the efficiency of ERT over time, particularly in patients presenting an atypical     phenotype. The entire cohort treated or not treated with ERT, will be evaluated at baseline     and every year during a 5-years period. The complete evaluation at baseline will be our     absolute priority as well as obtaining long-term and exhaustive follow up of the patients     treated with ERT (two patients of the cohort already treated, and ERT expected in three     additional patients in the next months).      The investigators designed a schedule of systematic and exhaustive assessments based on the     recommended follow up from experts panel consensus meeting (MorCAP protocol) extended to some     additional investigations including motor, cardiac and rheumatologic exams as our specific     focus.   "
6227|NCT03204357|"     Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss     24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate     levels.      The study design is a prospective randomized interventional trial of transfusion of fresh     autologous whole blood versus standard of care expectant management of bleeding during     elective cardiac surgery.   "
6228|NCT03204344|"     For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate     improves postoperative recovery. The purpose of this pilot study is to investigate the impact     of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after     gastrointestinal surgery.   "
6229|NCT03204331|"     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once     daily, co-administered with low-dose estradiol and norethindrone acetate compared with     placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.   "
6230|NCT03204318|"     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once     daily, co-administered with low-dose estradiol and norethindrone acetate compared with     placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.   "
6239|NCT03204201|"     This is an open-label feasibility study utilising direct instillation of ICG into the urethra     during surgery for low rectal cancers. The trial involves a single intervention taking place     during the patient's operation. Participants will be included in the study for around 2     months with time either side of the intervention to collect background data.   "
6368|NCT03202524|"     Large volume paracentesis with albumin administration is the standard of care for patients     with refractory ascites complicating end-stage liver disease. However, the use of albumin is     frequently limited due to expense and occasional short supply. The goal of this study is to     demonstrate if the administration of fresh frozen plasma (FFP) is as effective as albumin for     volume expansion at the time of a large volume paracentesis.   "
6231|NCT03204305|"     All participants will be healthy volunteers and all procedures will be completed for research     purposes only. Two groups will be recruited, females who use cannabis (marijuana, MJ), and     female who do not use cannabis (controls). Female MJ users will be enrolled in a protocol     that includes an outpatient drug administration session and a 4-day/3-night inpatient stay on     the Johns Hopkins Bayview Clinical Research Unit (CRU). During outpatient visits, MJ users     will have an MRI, and complete MJ self-administration and cognitive performance sessions. MJ     users will then reside on the CRU,and complete MJ abstinence, and self-report instruments for     craving, mood and any withdrawal discomfort. A positron emission tomography (PET) scan of     brain cannabinoid type 1 receptors will also be completed. Non-users will complete MRI, PET     imaging and cognitive testing under an outpatient protocol (no MJ administration).   "
6232|NCT03204292|"     ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao)     depends on the daily balance of fluids.   "
6233|NCT03204279|"     This study is Phase 2 pharmacokinetic (PK) and pharmacodynamic (PD) dose-finding study of     oral netupitant administered concomitantly with oral palonosetron in pediatric cancer     patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy.     Two different netupitant dosages will be tested in patients aged from 3 months to < 18 years:     1.33 mg/kg up to a maximum of 100 mg, and 4 mg/kg up to a maximum of 300 mg. All netupitant     doses in all age classes will be concomitantly administered with palonosetron 20 μg/kg (up to     a maximum dose of 1.5 mg) which is the IV palonosetron dose approved by USA FDA for the     pediatric population. The primary objective is to investigate the PK/PD relationship between     netupitant exposure (AUC, Cmax) and antiemetic efficacy (CR in delayed phase) after a single     oral netupitant administration, concomitantly with oral palonosetron in pediatric cancer     patients receiving Moderately Emetogenic Chemotherapy (MEC) or Highly Emetogenic Chemotherapy     (HEC) cycles. Efficacy parameter to be used in the correlation is the proportion of patients     with Complete Response (CR i.e., no emetic episodes and no rescue medication) during (>     24-120 h after the start of chemotherapy on Day 1).      The secondary objectives are to assess the safety and tolerability after single oral     administration of netupitant given concomitantly with a single oral administration of     palonosetron; to evaluate the pharmacokinetic (AUC, Cmax, tmax and t1/2) of oral palonosetron     at the fixed dose of 20 μg/kg in pediatric patients with the concomitant administration of     netupitant. A total of 92 pediatric cancer patients receiving either HEC or MEC will be     enrolled in the study.   "
6234|NCT03204266|"     The goal of this clinical research study is to learn if an Arginine recovery supplement     (which has l-arginine and also contains protein) and Omega-3 fatty acids can help     inflammation and recovery after Radical Cystectomy (RC) in bladder cancer patients.   "
6235|NCT03204253|"     Pregnancy rates fall dramatically in women after 35 years undergoing to IVF or ICSI. While     ovarian aging obviously plays the major role in this phenomenon, over suppression of     endogenous LH concentrations with GnRH agonists or antagonists—an integral part of standard     IVF/ ICSI protocols—may also play a pivotal role.      Assisted reproduction technology protocols using GnRH agonists have been considered as the     standard protocol during the last two decades, but the use of GnRH antagonists offers the     opportunity to control the endogenous LH surge in a rapid and more convenient way.      LH plays a key role in the intermediate-late phases of folliculogenesis. The presence of     receptors for LH in cumulus granulosa cells and its correlation with oocyte maturation has     been demonstrated. Although ovarian stimulation is efficiently achieved in most cases by the     administration of exogenous FSH alone, specific subgroups of women may benefit from LH     activity supplementation during ovarian stimulation. Some authors have found improved outcome     with LH activity supplementation in advanced reproductive age women.      LH has a number of roles in follicular development, induction of ovulation, completion of     meiosis I, early luteinization and the production of progesterone.      The efficacy of recombinant human follicle-stimulating hormone (r-hFSH) for ovarian     stimulation is well established however, the role of supplementary recombinant human     luteinizing hormone (r-hLH) is less clear.      Aim of the present study is to evaluate If adding rLH in the late phase of stimulation can     benefit in some patient awith repeated implantation failure.   "
6236|NCT03204240|"     Individuals with spinal cord injury (SCI) live longer than before and live to an age where     metabolic disorders become highly prevalent. Due to loss of mobility and severe skeletal     muscle atrophy, obesity, glucose intolerance, and peripheral insulin resistance develop soon     after the onset of SCI. These abnormalities are thought to contribute to the increased     diabetes disease risk and accelerated aging process in the SCI population. As a result of     these trends, overall burden of complications, economic impact and reduced quality of life     are increasing. Until there are effective treatments for SCI, it is imperative to develop     effective interventions to mitigate metabolic disorders that develop in individuals with SCI.     The proposed research project examines the impact of early utilization of a novel     neuromuscular electrical stimulation (NMES) program on skeletal muscle metabolism and overall     metabolic health in individuals with sub-acute, complete SCI.   "
6237|NCT03204227|"     A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine     (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess     the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children     are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive     2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data     included immediate reaction at the injection site and systemic reaction within 30 min of     administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34     days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start     of first dose to 28-34 days after second dose).   "
6238|NCT03204214|"     Case Control Study :      Objective:      Frequent Binge drinking during 18-25 years is a risk factor of alcohol addiction in adulthood     (25-40 years) Hypothesis: 25% of frequent binge drinking, OR = 2, power 80%, alpha risk : 5%     126 Cases aged 25 to 40 years: alcohol addict patients recruited in Addiction Unit in Rouen     University Hospital 126 controls aged 25 to 40 years: non alcohol addict recruited by the     Clinical investigation center in Rouen University Hospital An anonymous self-questionnaire     was completed Binge Drinking during 18-25 years was retrospectively evaluated Confusion biais     was also recorded   "
6274|NCT03203746|"     Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on     GCF Level of Oxidative Stress Marker; Protein Carbonyl   "
6242|NCT03204162|"     There is significant data showing that the quality of CPR performed is quite poor. Recent     studies have shown that when real-time visual corrective feedback is available to CPR     providers, quality (compression depth and rate) improves.      Pilot work at John's Hopkins Children's Hospital indicates that providing a CPR Coach whose     role it is to provide real-time coaching during cardiac arrest, further improves the quality     of CPR. This study will assess the impact of a CPR Coach for improving CPR quality and CPR     perception in a team of healthcare providers during simulated CPA.   "
6243|NCT03204149|"     This is a randomized, double blind, placebo-controlled study to evaluate the safety of the     low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic     Foot Ulcer (DFU) that has been present for at least 3 months.      Eligible subjects will be randomized to either Treatment group or Control group, following     which, treatment of each subject will be provided by a qualified nurse at the clinic or in     the home setting, everyday for up to 16 weeks.      Study assessments and adverse events monitoring will be also performed throughout the study.   "
6244|NCT03204136|"     Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in     treating inflammatory bowel diseases. Yet some patients develop severe side effects or     initial invalid to conventional therapies. Some studies have already showed that tarcolimus     and methotrexate are both effective in inducing and maintaining disease remission. Here we     conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in     treating refractory inflammatory bowel diseases as rescue therapy.   "
6245|NCT03204123|"     The purpose of this study is to see if a new diagnostic research agent named     68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other     standard imaging even when the PSA levels are very low.   "
6246|NCT03204110|"     Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity     characterized by severe headaches (associated or not with neurological complications) during     one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral     arteries, which resolves spontaneously in 3 months. The pathway is unknown. At early stage of     the disease (at the first medical consultation) cerebral arterial abnormalities which are     necessary for diagnosis are identified in only 20% of patients (brain magnetic resonance     imagery (MRI) ,CT scan angiography), appearing with a delay on 2th or 3rd week after the     first severe headache..      Retinal artery network is considered to be a window on brain microvasculature by sharing the     same embryologic origin and physiopathology. A retinal arteriolar examination at early stage     of RCVS could provide non invasively early clue to confirm diagnosis by identifying     anatomical change and /or functional abnormalities at the microvascular level, whereas large     cerebral artery abnormalities are still normal.   "
6247|NCT03204097|"     Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative     properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as     a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic,     antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant     anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV     gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the     treatment of degree II furcation defects   "
6248|NCT03204084|"     Pterygium is a wing-shaped fibrovascular tissue that has proliferated onto the cornea.     Ultraviolet radiation and hot, dusty, windy, dry, smoky environments are regarded as risk     factors for pterygium . Surgical removal is the treatment of choice, and surgical wound     intraoperative and inflammatory response postoperative have been considered two of the most     significant factors that can increase the recurrence rate of pterygium. Low-Temperature     Plasma Surgery System(LTP), avoids causing burn injuries to patients, has been introducing     into minimally invasive surgery. The mechanism by which this equipment stop bleeding and     abolish tissue is to directly occupy the injury with the formed blood clots, plasma flows     close the vessel and plasma active particles cause physical and chemical reactions with     tissue. The different levels of energy density of plasma can affect the bacteria, cells and     cancer cells and even to death, therefore it is widely used in the disinfection of medical     devices, dental root canal therapy, skin disease treatment and surgical wound disinfection.     Whether it's possible to apply the advantages and benefits of plasma technology in ophthalmic     surgery? Like pterygium surgery? However, there is no research to answer until now. In this     study, the investigators retrospectively observed the efficacy, postoperative discomfort,     inflammation, complications, and recurrence rates in a group of patients for whose LTP was     used in pterygium excision and wound hemostasis. The investigators Observe the clinical     benefits of LTP in pterygium surgery and find the facilitates and problems it need to be     addressed reasonably.   "
6249|NCT03204071|"     Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts     differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favorable     effect on alveolar bone.      AloeVera Gel had also been used in dentistry and showed good results.The present study aims     to explore the efficacy of 1% MF gel and aloe vera gel as a local drug delivery system in     adjunct to scaling and root planing (SRP) for the treatment of subjects with chronic     periodontitis (CP) with intrabody defects.   "
6250|NCT03204058|"     Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts     differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a     favourable effect on alveolar bone. Statins are one of the lipid lowering drugs that help in     reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl     coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin     (RSV) have shown to have bone stimulatory and anti-inflammatory effects.Statins are one of     the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically     inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme     for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone     stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of     1.2% RSV and 1MF gel as a local drug delivery and redelivery system as an adjunct to scaling     and root planing (SRP) for the treatment of intrabony defects.   "
6251|NCT03204045|"     This study was performed to compare the effects of oxycodone and fentanyl on airway and     hemodynamic responses and postoperative pain during recovery period in patients undergoing     laparoscopic cholecystectomy.   "
6256|NCT03203980|"     The optimal antithrombotic therapy for patients requiring anticoagulation after coronary     stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation     (triple antithrombotic therapy) remains the Gold standard.      Our study aims at studying bleeding events occurring until 6 months after the initiation of     triple antithrombotic therapy.   "
6257|NCT03203967|"     Single femoral nerve blockade combined with patient-controlled intravenous analgesia are used     for postoperative analgesia for patients after TKA in the hospital of the investigators.     Although this method provides acceptable analgesia, the incidence of opioid-associated side     effects is relatively high. Low-dose epidural morphine is commonly used in postoperative     analgesia after cesarean section, and the effect of single dose morphine lasts more than 20     hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The     investigators hypothesize that, for patients undergoing TKA, the addition of low-dose     epidural morphine to single femoral nerve block and intravenous opioids can improve the     postoperative analgesia, reduce the consumption of intravenous opioids and decrease     opioid-associated side effects.   "
6258|NCT03203954|"     Major depression is a prevalent and impairing illness. To better understand the basic science     and treatment of depression, the investigators study the behavioral and brain processes     associated with learning in depression and how potential disruptions in learning may be     repaired. Understanding different methods that change learning may lead to novel treatments     that contribute to recovery in people with depression.   "
6259|NCT03203941|"     Individual patient expanded access protocol for a child with cerebral palsy (CP) who has     autologous umbilical cord blood available and who is ineligible to participate in other stem     cell studies for children with CP.   "
6260|NCT03203928|"     Although woman are diagnosed with Attention-deficit hyperactivity disorder (ADHD) at a 1:3     ratio with men, recent research suggests that woman may experience the same levels of adult     ADHD as men but are underdiagnosed because symptoms may be less severe and/or mistaken for     anxiety and depression. Women with ADHD typically experience problems in managing worker,     student, spousal, and parenting roles dues to disorganization, poor time management,     difficulty regulating internal and external stressors, and difficulty maintaining daily     schedules and routines. Intervention effectiveness research has largely focused on     pharmacological treatment of ADHD symptoms; however, while such pharmacological treatment     tends to enhance concentration and reduce motor restlessness, it does not address the skills     needed to successfully carry out daily life roles and activities dependent upon time     management, prioritization of tasks, and regulation of emotional responses within the home,     school/work, and community environments. In this study, the investigators aim to determine     whether a 7-week tailored occupational therapy intervention addressing organization, time     management, stress management, and sensory regulation in the home, school/work, and community     environments can increase satisfaction in desired daily life activities, and reduce ADHD     symptoms and stress levels in women with ADHD.   "
6261|NCT03203915|"     To determine if the addition of chardonnay grape pomace powder enriched with grape seed     extract to the diet will result in reducing blood levels of cholesterol or triglycerides.   "
6314|NCT03203226|"     Loss of functioning and age-related health problems tend to appear earlier in individuals     with intellectual disability (ID) than in their non-disabled peers and due to this people     with ID who are in employment tend to need to retire earlier, producing social, economic and     health problems. The Feldenkrais method (FM) is a movement-based form of learning that     enhances body balance and physical functioning. We hypothesized that the FM could be helpful     to improve balance and functioning of employed people with ID.   "
18616|NCT03041896|"     To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2     levels with the coflex® Interlaminar Technology or decompression with or without fusion.   "
6262|NCT03203902|"     Many formerly homeless adults with chronic mental illness experience treatment resistant     symptoms for which pharmaceutical agents and cognitive behavioral therapy are not effective.     Although formerly homeless adults with chronic mental illness typically receive medical and     psychiatric services to manage their illness, chronic stress and post-traumatic stress     disorder (PTSD) acquired from homelessness are difficult to resolve and many adults     experience relapse that can result in housing loss. Therapeutic touch is a complementary and     alternative treatment that has been shown to be effective at reducing stress, anxiety, and     pain in a variety of diagnoses including cancer, cardiac disease, chronic pain syndromes, and     PTSD in veterans. In this study the investigators aim to determine whether a 30-minute     therapeutic touch session combined with a conventional 1-hour psychoeducation group delivered     over 6 weeks can more effectively reduce stress compared to conventional psychoeducation     alone. The ability to reduce stress levels and maintain emotional equilibrium is critical for     this population to manage illness symptoms effectively and stave off the incidence of     relapse, rehospitalizations, and housing loss.   "
6263|NCT03203889|"     It is important to address the substantial substance-related health disparities of American     Indians (AI). This project aims to examine the effectiveness of a culturally tailored     Community Reinforcement and Family Training (CRAFT) approach and Twelve-step facilitation     with Concerned Signficant Others (TSF-CSOs) among AIs to increase engagement of treatment     refusing individuals into treatment/healing and to reduce distress of their loved ones. Study     hypotheses are that (1) CRAFT will result in higher numbers of people entering treatment for     substance use disorders than will TSF-CSO, (2) both groups will yield similar improvements in     the family member's functioning, and (3) we will explore potential factors of the treatments     to see which aspects of the treatment are most important and to test which characteristics of     the clients impact the outcomes for better or worse. This knowledge may impact dissemination     and diffusion efforts for CRAFT-AI and other evidence-based treatments among AIs and other     culturally diverse groups.   "
6264|NCT03203876|"     The purpose of this study is to determine whether lirilumab in combination with nivolumab or     in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or     metastatic solid tumors   "
6265|NCT03203863|"     The purpose of this study was to cross-sectionally evaluate nutritional status and the     metabolic syndrome in a sample of school-age children 10-15 years of age from 20 public     schools in Santiago, Chile. In addition, the investigators retrospectively assessed the     association of those variables with perinatal variables (birth weight, birth length, and     gestational age at delivery).   "
6266|NCT03203850|"     The purpose of this study is to evaluate the efficacy and safety of deferasirox film coated     tablet (FCT) versus phlebotomy for the management of iron overload in adults with HH at risk     of iron-related morbidity. This evaluation will provide information on the two treatment     options in terms of the rate of response of proportion of patients reaching the study target     SF ≤ 100 μg/L and their associated safety profiles.      In addition to exploring the safety and efficacy of deferasirox FCT in hereditary     hemochromatosis (HH), this study is being conducted to fulfill an FDA post-marketing     requirement [PMC 750-10 (Exjade) /PMR 2888-8 (Jadenu)] to provide additional randomized data     to confirm the ocular safety profile of deferasirox through detailed ocular assessments in     patients treated with deferasirox FCT for 2 years.   "
6267|NCT03203837|"     To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma     patients who undergo radioembolization.   "
6268|NCT03203824|"     The purpose of this graduate student study is to determine if ingestion of dark chocolate     (70% cacao) will change brain frequencies between visualization at a state of rest and a     state of exercise performance via electroencephalography (EEG) in vigorously active     individuals.   "
6269|NCT03203811|"     Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3     levels. Ten subjects will be enrolled at each dose.   "
6270|NCT03203798|"     In the current scientific literature, it is clear that SUI can cause several social, hygienic     and personal relationship problems. It has also been proven that this condition affects many     more menopausal women than menacme, and this is believed to be due to the hypoestrogenism     characteristic of this phase.      On the other hand, weakness of the pelvic floor muscles (PFM) is also related to the genesis     of SUI. The role of these muscles would be to keep the bladder neck elevated (above the pubic     symphysis) during increases in abdominal pressure, and its weakness would lead to excessive     lowering of the bladder neck at these times, leading to SUI due to bladder neck     hypermobility.      The conservative treatment of this condition, therefore, encompasses the strengthening of     PFMs, which would avoid excessive descent of the bladder neck during increases in abdominal     pressure, thereby reducing urinary loss.      In the current literature there are studies proving the effectiveness of pelvic floor muscle     training; however, in relation to the literature on abdominal hipopressive gymnastics, it is     observed that the scientific evidence is still poor, however, the technique is still Widely     spread through extension courses offered throughout Latin America, France and Spain; With     regard to the comparison of these methods with respect to their clinical efficacy and the     quality of life and patient satisfaction, there are no consistent studies, and this fact     motivated us to carry out this study.   "
6271|NCT03203785|"     The study is a randomized, double-blinded, placebo-controlled trial that will include the     participation of 16 Jiu-Jitsu athletes between 18 and 30 years. The aim of the study is to     evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle     damage in Jiu-Jitsu athletes.   "
6272|NCT03203772|"     Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain     syndrome, is affected by virtual reality. While several studies have looked into virtual     reality for treating this type of pain, few have used the latest immersive virtual reality     hardware combined with motion control for an engaging virtual mirror therapy experience. The     investigators are interested in studying the use of virtual reality as an alternative     treatment option for these conditions.   "
6273|NCT03203759|"     The investigators propose a home hospital model of care that substitutes for treatment in an     acute care hospital. Limited studies of the home hospital model have demonstrated that a     sizeable proportion of acute care can be delivered in the home with equal quality and safety,     reduced cost, and improved patient experience.   "
6275|NCT03203733|"     This study evaluates, among study patients with lymphoma or myeloma undergoing autologous     SCT, whether cooling oral mucosa with a cooling device compared with ice cubes/crushed ice or     ice pop succeeds in reducing the degree of oral mucositis (OM) according to the Oral     Mucositis Assessment Scale (OMAS) total,degree of OM according to World Health Organisation     (WHO), tolerability of either cooling method. The study is also aiming to , patients     subjective experience of OM, rating of general quality of life and oral pain, number of days     with total parenteral nutrition (TPN), number of hospital days, total dose of opioids, and C     reactive protein during time in care.      Finally, the study aims to evaluate weight loss, Leukocyte particle concentration, number of     days until bone marrow response, S-albumin, and body temperature.   "
6276|NCT03203720|"     Adolescence is the peak onset period for serious and persistent psychiatric disorders.     Treatment guidelines for management of major psychiatric disorders in youth include     pharmacotherapy. There has been substantial progress in recent years in identifying effective     medications for youth with psychiatric disorders. However, adherence to prescribed     medications among psychiatric populations is notoriously low, and adolescents rank among the     least adherent of all patient populations. Given that the consequences of poor medication     adherence among youth with chronic mental illness are far-reaching, including     hospitalization, poor functioning, and suicide, there is a desperate need for interventions     targeting medication adherence in this population.   "
6277|NCT03203707|"     Bipolar disorder is a severe and chronic illness associated with significant occupational and     social impairment, enormous public health costs, and high rates of suicide. The single most     potent risk factor for the development of bipolar disorder is a first-degree family member     with the illness; indeed, offspring of parents with bipolar disorder are a particularly     high-risk group who typically display early onset and severe course of illness. Thus, early     assessment and intervention for the children of parents with bipolar disorder focused on     specific, measurable, and modifiable risk factors has the potential to prevent or ameliorate     the progression of bipolar disorder in those at highest risk.   "
6278|NCT03203694|"     The purpose of the present study is to determine the effects of increased walking on leg     vascular function in patients with type 2 diabetes (T2D).   "
6300|NCT03203408|"     The main objective of the study was to demonstrate the non-inferiority of the efficacy of a     single intra-articular injection of OSTENIL PLUS compared to that of a single intra-articular     injection of the reference product SYNVISC-ONE in the treatment of symptomatic tibiofemoral     osteoarthritis. The primary endpoint was the change in mean score on the WOMAC pain scales     from D0 to D180.   "
6279|NCT03203681|"     Low testosterone affects more than 10% of men worldwide, with high incidence in the     elderly.This will be a prospective case study. The investigators will identify men with     hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT).     Natesto is a relatively new form of testosterone replacement therapy that is delivered     intranasal to men diagnosed with low testosterone. Current advantages to Natesto include ease     of delivery and decreased risk of transference. Recently Natesto 4.5% (125 uL/nostril, 11.0mg     testosterone/dose), three times a day (TID) dosing was shown to also increase serum     testosterone while maintaining normal, though decreased, serum levels of Luteinizing Hormone     (LH) and Follicle-Stimulating Hormone(FSH). 40 participants will be enrolled and receive     treatment with Natesto.The study will identify men with confirmed hypogonadism (testosterone     (T) <350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between     6am and 10am with demonstrated symptoms of hypogonadism). Participants with a history of     prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be     excluded.   "
6280|NCT03203668|"     To assess the efficiency of 18F-fluorocholine PET/CT in localization of hyperfunctioning     parathyroid tissue in hyperparathyroidism, thereby enabling minimally invasive surgical     approaches with fewer complications and comparable success rates   "
6281|NCT03203655|"     Hispanic populations in the US are dis-proportionally affected by high rates of obesity and     diabetes; according to the Centers for Disease Control and Prevention, Latinos are the     minority group with the second-highest obesity prevalence in adults. In comparison to the     general female population (61.2%), Mexican American women (73%) have a greater overweight or     obese percentage. In addition, more than 50% of Hispanic men and women are expected to     develop type-2 diabetes over their lifetime, compared to 40% among whites. Hispanics are also     50% more likely to die from diabetes compared to whites. In many cases Hispanic populations     do not have the knowledge, self-confidence and resources to participate in mainstream     physical activity and nutrition interventions, which are usually geared towards the general     population without considering cultural and linguistic differences.      Information and communication technologies in the form of Internet and mobile phone access     have grown enormously during the past decade; these technologies have the potential to affect     food intake and physical activity as well as weight loss. Approximately 95% of countries have     mobile telephone networks and about 70% of people worldwide use mobile phones.      CareMessage is a Google-backed 501(c)3 nonprofit technology organization based in San     Francisco that uses 'smart' text and voice messaging to enable clinical staff to provide     automated yet personalized support to patients struggling with chronic conditions. The     CareMessage™ Adult Obesity texting program adapts the Health Belief Model by strategically     implementing behavioral concepts to help improve self-efficacy.      The investigators will pilot test its effectiveness among a sample of Hispanic women who are     at risk of obesity and diabetes by sending a culturally-sensitive and     linguistically-appropriate text-based message three to 5 times a week, encouraging lifestyle     modifications (diet and exercise education and behavior modification).   "
6282|NCT03203642|"     The goal of the study is to compare and evaluate safety and efficacy of tesevatinib 50mg     versus placebo in patients with ADPKD.   "
6283|NCT03203629|"     To conduct a prospective, observational study to evaluate the non-interventional feasibility     of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter     Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.   "
6284|NCT03203616|"     Women with breast cancer often develop metastases in the brain. Currently, treatment of these     metastases is difficult and relies on radiotherapy or surgery which often fail. Therefore,     development of new methods of treatment for breast cancer with brain metastasis is very     important. T-DM1 is a drug that is already in everyday use for a specific type of breast     cancer called HER2-positive breast cancer. The objective of this study is to investigate     whether T-DM1 is also effective in brain metastasis and can help patients to live longer and     better   "
6285|NCT03203603|"     The overall aims of this protocol are to determine whether prenatal supplementation with     vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years     of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring     through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial     that supplemental vitamin C in pregnant smokers can significantly improve their children's     PFTs and decrease the incidence of wheeze.   "
6286|NCT03203590|"     The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant     Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC     patients with EGFR mutation.   "
6287|NCT03203577|"     Objective: To prove that initiation of chronic ventilatory support at home, in patients with     chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage     problem is not inferior compared to initiation in a hospital based setting. In addition we     believe that the start at home is cheaper compared to an in-hospital start.      Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost     effective compared to a hospital-based initiation.      Study design: A nationwide non-inferiority multi-center randomized parallel active control     study.      Study population: Patients with chronic respiratory insufficiency due to a neuromuscular     disease (NMD) or thoracic cage problem who are referred for chronic ventilator support.      Intervention: The start of HMV at home Standard intervention to be compared to: The start of     HMV is normally in a clinical setting as recommended in the national guideline.      Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function;     nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size     calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome.     A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as     non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96     patients in total.      Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial.     Costs of the initiation of HMV at home and in the hospital will be estimated form a societal     perspective over a time horizon of 6 months.      Time schedule: After an initial phase of 6 months recruitment will start and will take 24     months. Thirty-six months after the start of the study the last assessments will be done and     analysis and writing of the papers will start. After 42 months the study will end.   "
6288|NCT03203564|"     The purpose of this study is to evaluating ECG effects, safety, tolerability and     pharmacokinetics of single ascending dose of Modufolin® in healthy male volunteers   "
6301|NCT03203395|"     Depression is a risk factor for morbidity and mortality in patients with heart disease, and     has a negative impact on quality of life, work capacity and treatment adherence. Screening     for depression among heart patients are therefore recommended by the Norwegian Health     Authorities. Also, symptoms of anxiety may negatively affect rehabilitation due to e.g. fear     of physical activity and excessive worry. Patients currently receiving treatment for heart     disease at Diakonhjemmet Hospital will be screened for symptoms of depression and anxiety. If     such symptoms are detected, patients will be offered a counselling session with a clinical     psychologist. Further, routines for collaborative communication between clinical     psychologist, cardiologist and the patient's general physician will be emphasized.   "
6302|NCT03203382|"     Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for     ocular symptoms and corneal nerve morphology. We are specifically interested in the     relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.   "
6289|NCT03203551|"     This clinical study identified the Candida species from the palate and complete dentures of     edentulous individuals with prostheses-related stomatitis (PRS) and evaluated the effect of     disinfectant solutions for denture hygiene on Candida spp. Sixty participants were randomly     assigned in 04 parallel groups (n = 15); They were oriented to brush their prostheses and the     palate 3 times a day and immerse them in saline solution (C-control), 0.25% Sodium     hypochlorite (HS0.25%), 10% Ricinus communis (RC10%) or 0.5% Chloramine T (CT 0.5%) for 20     minutes. Biofilm samples were collected from the prostheses and palate in the baseline, after     7 and 37 days of use of the solutions and seeded in CHROMagar Candida medium. After     incubation period, the presumptive identification, incidence verification and quantification     of Candida species growth (CFU count) were performed. To quantify biofilm with software     ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at the end     of each period. The Candidiasis remission was assessed by scores before and after the use of     solutions by palate's phographs. Descriptive analyzes were used for the identification and     incidence of Candida spp. Kruskal-Wallis and Friedman tests, with stepwise step-down     post-test for cell growth; ANOVA and Tukey for biofilm removal; Frequency of scores for     evolution of inflammation. Level of significance was 95%. The most incident species were C.     albicans, followed by C. tropicalis, C. glabrata and C. krusei. HS 0.25% reduced the     incidence of the three species on the prostheses and palate in the periods of 7 and 37 days;     CT 0.5% promoted reduction of Candida spp. only in dentures. R. communis decreased the     incidence of C. tropicalis in both collection sites. For CFU counts, HS 0.25% and CT 0.5%     caused significant reduction. For biofilm removal, HS0.25% was the most effective (9.75 ±     12.6) and RC10% (15.92 ± 14.8) intermediate. All groups decreased protheses-related     stomatitis. HS0.25% has potential for clinical use as total denture disinfectants. RC10% and     CT0.5% require further studies to be indicated as alternative solutions.   "
6290|NCT03203538|"     The project will contribute with new knowledge concerning how aspects of the physical work     environment (lighting conditions) can be arranged to facilitate the workers' adaptation to     night work. This is important given the reported adverse consequences of shift work for     performance, safety, and health. The project involves a series of three experimental,     laboratory based shift work simulation studies. The aim is to investigate how different     lighting conditions (intensities and colour temperature), administered through light emitting     diode (LED) based bright light integrated standard room lighting, affects adaptation to three     consecutive simulated night shifts and re adaptation to a day oriented schedule on measures     of alertness, cognitive performance, sleep and circadian rhythm. The proposed project     examines the effects of interventions that can be applied in naturalistic settings and will     be based on new laboratory infrastructure available at the laboratories situated in the     Faculty of Psychology, University of Bergen.   "
6291|NCT03203525|"     The goal of this clinical research study is to find the highest tolerable dose of 2 study     drug combinations that can be given with the NovoTTF-100L system at 150kHz. The NovoTTF-100L     System is a portable device that uses electrical fields to stop the growth of tumor cells.      The first study drug combination is modified FOLFOX6 (folic acid, leucovorin, fluorouracil,     and oxaliplatin) mFOLFOX6 and bevacizumab. The second study drug combination is liposomal     doxorubicin, bevacizumab, and temsirolimus. Patients in both combinations will also receive     treatment with the NovoTTF-100L system.      The safety of these combinations will also be studied.   "
6292|NCT03203512|"     N-3 polyunsaturated fatty acids (n-3 PUFA), which are abundant in oily fish and fish oils,     have been suggested to play a role in reducing the risk of cardiovascular diseases (CVDs) by     modifying a wide range of risk factors, such as blood fats, blood clotting, blood vessel     function and inflammation. Extracellular vesicles (EVs) are small particles released from     various cells when they are activated or damaged. High numbers of EVs in the blood have been     associated with a higher risk of CVDs, and it is thought that this is because they carry     'bioactive' components which can affect many processes involved in CVDs. However, very few     clinical trials have investigated the relationships between the consumption of n-3 PUFA and     circulating EVs. This study aims to investigate the effects of dietary n-3 PUFA on the     generation and functional activities of EVs, which would provide new insight into the     benefits of n-3 PUFA on cardiovascular health.   "
6293|NCT03203499|"     This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose     study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels     of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a     screening visit, a qualification visit, a Treatment Phase and follow-up.   "
6294|NCT03203486|"     The effects of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile     in NAFLD patients with simple steatosis. Potential associations of single nucleotide     polymorphisms to diet composition and patients' profile were also investigated.   "
6295|NCT03203473|"     This research study is studying two drugs at different time points as a possible treatment     for advanced renal cell cancer      The drugs involved in this study are:      Nivolumab Ipilimumab   "
6296|NCT03203460|"     The primary aim of this study is to examine the effects of exercise on anti-cancer immune     activity related to tumour progression in prostate cancer patients undergoing active     surveillance.   "
6297|NCT03203447|"     This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed     to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT)     aflibercept (EYLEA® ; Regeneron; Tarrytown, NY and Bayer, Berlin, Germany) in subjects with     treatment naive RVO is superior to IVT aflibercept used alone.   "
9353|NCT03163511|"     The purpose of this trial is to test if VC-02™ combination product can be implanted     subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained     safely for up to two years. It will also test if VC-02 is an effective treatment for these     subjects.   "
6298|NCT03203434|"     Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with     malignant tumors of the esophagus or pancreatic head. These procedures are associated with     high morbidity rates, which are strongly correlated with the occurrence of anastomotic     leakage. Current diagnostic methods, including clinical, biochemical and radiological     techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which     ratifies the need for development of novel and accurate non-invasive diagnostic tests for     detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic     status of an individual, which is associated with a systemic immunological response. The aim     of this study was to determine the diagnostic accuracy of urinary volatile organic compounds     to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early     phase.   "
6299|NCT03203421|"     The purpose of this study is to assess the safety, immunogenicity and efficacy of the     candidate malaria vaccines ChAdOx1 LS2 and MVA LS2.      Healthy adult volunteers will be recruited and vaccinated in Oxford.   "
6332|NCT03202992|"     This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal     precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.   "
6303|NCT03203369|"     A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster     of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed     or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose     expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.   "
6304|NCT03203356|"     To evaluate in children affected by idiopathic GHD the adrenal function both at baseline and     after 6 and 12 months of GH treatment.   "
6305|NCT03203343|"     Today there are various surgical techniques for inguinal hernia. In this study, investigators     want to compare the ''PIRS'' operating technique laparoscopy and modified Marcy operating     technique with open inguinal access. Investigators would compare both groups to find out     witch one does the lesser inflammatory stress response on the organism.   "
6306|NCT03203330|"     A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the     safety and efficacy of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3     Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial     joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a     single intra-articular injection to the damaged joint area via ultrasound guidance. Patients     will be followed for 24 months for safety and efficacy.   "
6307|NCT03203317|"     The study will investigate myocellular signalling in skeletal muscle after     insulin-stimulation and exercise in healthy young men   "
6308|NCT03203304|"     External beam photon stereotactic body radiotherapy (SBRT) using a linear accelerator to a     total dose of 40 Gy in 5 fractions delivered once daily with at least 48 hours between each     fraction. SBRT treatment will be completed within a 21-day window. Starting within 14 days     after completion of SBRT, intravenous nivolumab 240 mg will be given every 2 weeks as     monotherapy or in combination with ipilimumab 1 mg/kg IV every 6 weeks.   "
6309|NCT03203291|"     There are a number of common impairments resulting from stroke that contribute to motor     deficits which affect gait, or walking ability. These manifest as decreased walking speed,     and further, as stroke affects only one side of the body, there are resulting asymmetries in     time, spatial and force parameters during walking. Robotic-based therapies have been used to     increase walking speed and reduce asymmetry in a population of individuals after stroke,     however these therapies have demonstrated results similar to that of non-robotic, or     conventional training. This is possibly due to the control strategies used in robotic     training, which strategies limit participant involvement and reduce learning effect. The     Tethered Pelvic Assist Device (TPAD) is a robotic device that uses motorized tethers attached     to a belt at the user's pelvis to guide the pelvis along a pre-set movement trajectory. These     tethers can be configured in an infinite array of possibilities, and most recently have been     used to facilitate a body weight shift onto the paretic limb in a population of individuals     after stroke. Other robotic devices constrain the limb through the entire movement trajectory     and constrict the participants ability to participate in motor planning and movement     execution. The TPAD promotes weight shifting, but allows an individual to freely move the     limb and to navigate leg movement and foot placement independently, without constraints.     Further, if coupled with overground training to promote transfer of improvements to walking     over ground, this device maybe useful at improving symmetry in individuals after stroke.     OBJECTIVES: The purpose of this study is to evaluate the overall feasibility in terms of     safety, treatment tolerance and adherence as well as preliminarily address how effective this     treatment model using the TPAD and overground training would be to reduce load asymmetry on     the treadmill and promote increased stance symmetry on the paretic limb during overground     gait.PARTICIPANTS: A total of 12 individuals in the chronic (>6 months) stages post stroke     will be recruited from a voluntary stroke research database for participation. DESIGN: A     non-randomized pilot study of feasibility will be used to establish the feasibility and     preliminary efficacy of using the TPAD in combination with overground training to reduce load     force asymmetry in this population. METHODS: Participants will undergo a series of three     assessments within a one-week time frame prior to initiating intervention. Intervention using     the TPAD and overground training will occur during week 2 over 5 consecutive visits     (Mon-Fri). Participants will also complete short walks before and after the intervention with     an instrumented system that records individual walking characteristics. Participants will     return one-week after completing the intervention for a final test of walking and balance.     Each study visit will be approximately 1-1.5 hours in duration, and total participation     should be completed within three weeks. EXPECTED OUTCOMES: We anticipate this training     paradigm will prove feasible and effective in reducing both load and stance asymmetry in a     population of individuals with chronic stroke.   "
6310|NCT03203278|"     This randomised controlled trial aims to investigate the effect of a 12 week personalised     exercise programme delivered using a web-based platform, compared to usual care, on glycaemic     control, muscle strength, functional ability, blood lipid profile, blood pressure and quality     of life in adult South Asians with Type 2 Diabetes Mellitus   "
6311|NCT03203265|"     This study will ask Thai MSM and transgender women (TG) participants to self-select to     participate in one of the 3 different study groups which provide various degrees of     integrated online interventions and offline interventions for the Recruit-Test-Treat-Retain     for HIV prevention and care among 3 groups (A, B1 and B2). All participants will be followed     up either offline or online for 12 months. HIV-negative participants will be scheduled for     repeat HTC at months 6 and 12. HIV-positive participants will be scheduled either offline or     online to review their treatment history at months 6 and 12. HIV-negative participants in     Group B1 and B2 can choose again at months 6 and 12 to switch from the online to offline, and     vice versa, at the HIV testing/post-test counseling step and the referral to HIV treatment     step   "
6312|NCT03203252|"     Measuring appearance of implant-based breast reconstruction after mastectomy for breast     cancer - an online approach to research. Using 3-dimensional surface images we intend to     create a tool to measure appearance after surgery in order to improve standards of care for     women. We want to minimise the number of visits and amount of time involved in research     participation so this pilot study will develop new online tools for information giving and     gathering, and for consent so that only one visit to hospital will be required for     photographs. This will also extend the availability of expensive 3D technology to more women.   "
6313|NCT03203239|"     Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle     brachial index (<.9 or >1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above     the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and     subsequent acquisition of ultrasound images. 2 blood samples will be collected for     measurement of nitric oxide metabolites.   "
6315|NCT03203213|"     Poisoning by psychoactive substances is increasingly common in Europe and can be responsible     for deaths. These substances, also called festive drugs, circulate among other places in     festive gatherings (night clubs, concerts, free music, feria, etc.). The main objective of     this study is to determine the molecules that circulate in festive events in Aquitaine, in     order to implement prevention actions by looking at whether the circulating substances vary     with the style of event.   "
6316|NCT03203200|"     This study develops and tests a behavioural and structural intervention to prevent     unprotected sex among young female sex workers. Half the participants will receive the     intervention and half will receive the standard of care.   "
6317|NCT03203187|"     In the current proposal the investigators seek to evaluate the acute and short-term effects     of mango intake on vascular and platelet function in postmenopausal women between 50 and 70     years old.      Our aims are 1) to determine if two weeks of daily mango intake will result in favorable     changes in measures of vascular function, as measured using peripheral arterial tonometry     (PAT) and platelet reactivity, in overweight and obese postmenopausal women. 2) to determine     if two weeks of daily mango intake will change the fermentation capacity of gut microbiota.      Investigators hypothesize that the daily intake of 330 grams of mango (2 cups) will     significantly increase PAT while reducing platelet aggregation after 2 hours and two weeks of     daily intake.   "
6318|NCT03203174|"     Hyperhidrosis or sweating of palms results from the overactivity of sweat glands and leads to     psychosocial impairment with reduction in quality of life in those that are affected.     Injection of botulinum toxin has been shown to be effective in reducing the symptoms of     hyperhidrosis with associated improvement in quality of life, but is usually very painful.     Microneedles are a different modality for transdermal drug penetration without the pain. This     study aims to understand if botulinum toxin A can be delivered topically after microneedle     pretreatment in hopes of developing a minimally painful treatment protocol for treatment of     palmar hyperhidrosis.   "
6333|NCT03202979|"     The aim of the study is to collect preliminary information on the effect of low doses of     trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the     neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.   "
8875|NCT03169738|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with NSCLC who have progressed on or after treatment with PD-1/PD-L1     inhibitors.   "
6319|NCT03203161|"     While bariatric surgery is established as a safe and effective alternative with well-defined     risks for severely obese adults, little has been published on its use in children.      There are many unresolved questions concerning the long-term metabolic and psychological     consequences of bariatric surgery in adolescents, and the difference with the adult     population. The appropriate timing for bariatric surgery in young people, and the predictors     of success and safety still need to be determined.      The aim of this long-term prospective study is therefore to establish the safety and efficacy     profile of surgical procedures and to clarify whether reductions in morbidity and mortality     outweigh the risks of serious surgical complications and lifelong nutritional deficiencies.   "
6320|NCT03203148|"     In this observational study a comparison is made between two different monitors for     measurement of the activated clotting time (ACT): mechanical versus biochemical techniques   "
6321|NCT03203135|"     Staggered work affects about 20% of French employees and its health risks are now well known.     They concern physical health (sleep disorders, weight gain, cancer, cardiovascular disorders,     nutritional problems, etc.) and psychological health. Faced with these alarming findings,     it is necessary to find ways of improvement and levers of action to prevent them.      This project aims to set up and evaluate a nutritional health prevention programme for the     benefit of employees in staggered hours from CITEO. CITEO is a company of social mediation.      The objectives of the project are twofold: to evaluate the impact of working conditions in     shifted schedules on food behavior and on to improve their eating behaviors.      How? Focusing on the pleasure of eating through a nutritional prevention program in which     various and varied actions will be proposed but always adapted to the life of the company     (example: culinary demonstration, physical activity, provision of baskets of Fruits, etc.).   "
6322|NCT03203122|"     6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in     measured on several severity scores.   "
6323|NCT03203109|"     Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward     after a first hemispheric stroke. Postural and gait disorders in relation to referential of     verticality have been analyzed in routine care.   "
6324|NCT03203096|"     This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium     from magnesium citrate/magnesium oxide affects stress parameters in students in exam     preparation.   "
6325|NCT03203083|"     Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower     limb function as a preventive injury strategy. SLS clinical rating is a qualitative     evaluation and it does not count objective outcomes as kinematics data and surface     electromyography (sEMG) assessment. Based on the SLS rating, the aims of this study were (i)     to determine the clinical rating agreement among six raters and (ii) to assess kinematic and     sEMG predictors of good SLS performance in physically and non-physically active individuals.   "
6326|NCT03203070|"     A prospective randomized trial will be performed. Patients undergoing gastric bypass will be     randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane     (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative     intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group     2).      Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and     morphine needs will be quantified.   "
6327|NCT03203057|"     Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the     diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result     of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients     with chest pain and dyspnea.      Guidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending     on the assay. High-sensitivity assays measure concentrations that are ten-times lower than     earlier generations of assays. However, the time from when troponin is elevated in the     bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully     known.      During an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to     do a short, controlled occlusion of coronary artery by inflating a small balloon in one of     the coronary arteries. Numerous earlier studies in patients have used this method for induced     occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured     troponin I.      The aim with this study is to quantify and compare the release of troponin T and troponin I     in the early hours after a controlled induced ischemia.      Study Design This is a prospective, descriptive and experimental study. There will be     included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4     groups.      0: 10 patients - control group, no balloon occlusion        1. 10 patients - balloon occlusion for 30 seconds        2. 10 patients - balloon occlusion for 60 seconds        3. 10 patients - balloon occlusion for 90 seconds      Subsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6     hours: Every 30 minutes      Statistics This is a pilot study and it is estimated that ten patients are sufficient number     of patients in each group to assess elevation of troponin after occlusion of coronary artery.     The thesis is there is a dosage-response correlation between the length of balloon occlusion     and the concentration of troponin in blood stream.   "
6328|NCT03203044|"     Soylent 2.0 is a popular meal replacement drink that is used to supplement or replace one's     regular diet. Soylent is designed to fully fulfill one's nutritional needs, but its impact on     the human microbiome remains unknown. This study aims to track the composition of     participants' gut microbiomes before, during, and after Soylent consumption to more     holistically understand its impact on microbiome health. We predict that a short term     Soylent-based diet will induce observable and reversible changes to participants' gut     microbiomes.   "
6329|NCT03203031|"     Postoperative pain scores and analgesic requirements will be evaluated in neonates after     abdominal surgery, with regional quadratus lumborum block performed at the beginning of the     procedure.   "
6330|NCT03203018|"     The current health literacy (HL) pilot intervention was designed through focus groups with     women in low socio-economic status (SES) communities. The primary HL issue identified was     communication challenges at doctors' visits. As a unique HL intervention tailored to the     participants' preferences, this intervention can serve as a model for improving HL in similar     communities worldwide.      Objectives include increasing the percentage of women who utilize patient-doctor     communication skills and increasing their cardiovascular disease (CVD) knowledge. A unique HL     intervention tailored to the participants' preferences was designed which consisted of three     workshops conducted in municipality-sponsored women's groups in low SES Jerusalem     communities. Questionnaires were completed before and three months after the intervention.     The study answers the following: Can HL workshops improve patient-doctor communication skills     and CVD knowledge in low SES women?   "
6331|NCT03203005|"     This study is being carried out in order to evaluate a new cancer vaccine called IMA970A     combined with CV8102, a new adjuvant for the treatment of liver cancer (hepatocellular     carcinoma). It will be investigated whether IMA970A and CV8102 is safe and can trigger an     immune response against the tumor, which may prevent the tumor (cancer) from recurring or     spreading or may even lead to tumor shrinkage following the standard treatments the patients     have previously received.   "
6334|NCT03202966|"     This study is a cohort longitudinal design, also known as within subject repeated measures'     design to measure the impact of an early identification and intervention program being     implemented by Amar Seva Sangam (ASSA), an Indian non-government organization in South India.     The primary objective of the Early Intervention (EI) Village-Based Rehabilitation (VBR)     program is to increase access to early identification and early intervention therapy to     enhance physical, cognitive, language, social and emotional development of children with     developmental delays. The primary outcome will be the creation of developmental trajectory of     girls and boys with developmental delay who are receiving village based early intervention     therapy in rural India, aged 0 - 6 years based on the Gross Motor Function Measure - GMFM     (children with cerebral palsy only), Functional Independence Measure - wee-FIM, Functional     Assessment Checklist for Programming - FACP, Communication Developmental Eclectic Approach to     Language Learning - CDDC and Canadian Occupational Performance Measure - COPM. Secondary     outcomes will be the effect of therapy compliance rates on development in girls and boys with     developmental delay, the effect of therapeutic approach on development in girls and boys with     developmental delay, improved enrolment in school for children with developmental delays from     age 3 to 6; and, improved parent/caregiver knowledge, attitude, behavior and confidence in     caring for their child with developmental delay.   "
6335|NCT03202953|"     The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in     patients undergoing robot assisted laparoscopic prostatectomy   "
6336|NCT03202940|"     This research study is studying a drug combination as a possible treatment for anaplastic     lymphoma kinase-positive (ALK+) non-small cell lung cancer.      The drugs involved in this study are:        -  Alectinib        -  Cobimetinib   "
6337|NCT03202927|"     This study will compare treatment emergent incidence rate of ADA between TPI-120 and US     licensed Neulasta in normal healthy adult subjects   "
6338|NCT03202914|"     The present record represents a secondary data analysis of the Modification of Diet in Renal     Disease (MDRD) Study. For this analysis, the MDRD study data and specimens were retrieved     from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central     Repository. A global, untargeted, metabolomic profile was used to investigate biomarkers of     dietary intake as well as biomarkers of kidney disease progression.   "
6339|NCT03202901|"     The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week     treatment) both on mild/moderate knee pain   "
6340|NCT03202888|"     This project aims to create and evaluate a tool that gathers patient and family member     feedback and makes it rapidly available to providers, enabling nimble and responsive safety     and quality improvement efforts. Aim 1. Determine feasibility and acceptability of the     patient data collection and provider dashboard tool. The investigators will conduct usability     testing prior to study start, measure user (patients and providers) engagement over time, and     gather feedback about the tool at study end. This will test the hypothesis that patient and     caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and     caregiver- observed processes of care to providers leads to changes over time. The     investigators hypothesize that performance on structured items of interest will improve over     time with rapidly available data presented to providers. Aim 3. Estimate tool implementation     effect sizes, using a pre-post design, on medical errors.   "
6341|NCT03202875|"     Primary Objective:      To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.      Secondary Objective:      To assess the safety and tolerability of SAR341402.   "
6379|NCT03202381|"     The aim of this phase IV interventional study is to evaluate variation in bone mineral     density and lean and fat body composition in patients with prostate cancer without bone     metastasis, treated with Degarelix. These variations are evaluated at time 0 (before starting     androgen deprivation therapy with Degarelix) and after 12 months of therapy by dual-energy     X-ray absorptiometry (DXA scan).   "
6342|NCT03202862|"     This is an open-label, single arm, phase II trial to evaluate the efficacy and safety of     500mg Fulvestrant (Faslodex®) in ESR1 mutated postmenopausal women with hormone receptor     positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase     inhibitor therapy. Fifty patients will be enrolled and treated with 500 mg Fulvestrant until     disease progression or study closed.      Treatment will continue until disease progression, unless any of the criteria for treatment     discontinuation are met first. If a patient progresses during the treatment period, the     patient must be withdrawn from the treatment and further treatment will be at the     investigator's discretion.   "
6343|NCT03202849|"     The investigators hypothesize that supplementation with vitamins A and D will reduce the     incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with     supplementation with vitamin D alone.   "
6344|NCT03202836|"     This study evaluates the addition of vaginal progesterone in the management of preterm labor.     Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while     the other half will receive only tocolysis and corticosteroid.   "
6345|NCT03202823|"     Diabetes is associated with an increased risk of cardiovascular complications, as a     reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects     present impaired arachidonic acid metabolism. Moreover, atheromatous plaques in diabetic     subjects seem to be significantly enriched in 2-AA-LPC     (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture     than are plaques in non-diabetic subjects. We therefore hypothesize that this vulnerability     of atheromatous plaques in diabetic subjects could be explained by impaired 2-AA-LPC     metabolism within the plaque.   "
6351|NCT03202745|"     Inappropriate prescribing exposes patients to health risks and results in wasteful public     expenditures. This study will evaluate an approach to fighting abusive prescription: sending     letters to suspected potentially inappropriate prescribers warning them that they are     outliers compared to their peers and have been flagged for review. The study will target high     prescribers of opioids in the Schedule II controlled substances class. Two types of letters     will be tested: one focusing on the health consequences of inappropriate prescribing for     patients, and the other focusing on the consequences for prescribers including e.g. potential     administrative actions. Using claims data, the investigators will assess the effect of the     letters on prescribing of opioids, receipt of opioids by patients, substitution behavior by     prescribers and patients, and health outcomes of patients.   "
6346|NCT03202810|"     Oral cancer is a major health problem worldwide, accounting for 274,000 new cases and 145,000     deaths annually. On average, half of the patients die within 5 years of an oral cancer     diagnosis. Most troubling, however, is the lack of significant change in prognosis for this     disease over the last 4 decades, even in developed nations. Even when successful, treatment     of oral cancer can be devastating due to diminished quality of life and disfigurement. The     key to controlling this disease is early identification of lesions that are at high risk of     progression and provide effective treatment. The overall objective of the team is to     integrate clinical, pathological, molecular, and imaging data to create a robust oral cancer     risk model to predict the risk of progression of OPLs and to develop population-wide     cost-effective prevention strategies for high-risk oral premalignancies. The project will     involve 4 specific aims as described in detail below.      Aim 1. To use molecular data to stratify low-grade OPLs into high- and low-risk groups.      Aim 2. To evaluate the cost-effectiveness of various follow-up frequency that use LOH at     chromosome 9p21 as a risk marker.      Aim 3: To evaluate the specificity and sensitivity of using imaging technologies as a tool     for the decision of the high-grade or high-risk biopsy site.      Aim 4. To assess the clinical utility of a miRNA expression signature derived from serum     collected from patients with oral cancer and OPLs.   "
6347|NCT03202797|"     360 million people in the world suffer from debilitating hearing deficiency. The cochlear     implant is indicated in certain patients with severe profound deafness. The principle of the     cochlear implant is to directly stimulate auditory nerve fibres by electrodes inserted in the     cochlea. The steps in auditory rehabilitation are the surgical insertion of the cochlear     implant, activation, and follow-up regulation. There is no formal consensus to define the     exact modalities for regulation during activation or follow-up, but the principles are     respected according to centres that regulate cochlear implant. Bimodal audition is the fact     of having a cochlear implant and a contralateral hearing aid. In patients with cochlear     implants, having binaural bimodal audition improves their auditory vocal performance in     silence and in noisy environments. It needs to be considered when a second cochlear implant     is not indicated for the contralateral ear. It has been shown that by allocating frequencies     different from the default frequencies attributed by the manufacturer, intelligibility and     perception of music are modified. The investigators therefore with to study this working     hypothesis and to develop a simple protocol for the reallocation of frequencies in order to     optimise auditory performance in the everyday lives of patients with implants by using an     evolutionary algorithm.   "
6348|NCT03202784|"     This is an open-label, randomized study to investigate the relative bioavailability of two     formulations of BCX7353 and to determine if there is a food effect   "
6349|NCT03202771|"     Test the Efficacy of Home Biofeedback Training: Currently, biofeedback requires a skilled     therapist and sophisticated equipment and is not widely available. We designed and tested a     novel home biofeedback device and predict that home training will be as effective as office     biofeedback therapy. Our specific aims are to perform a randomized controlled trial of 100     subjects with dyssynergic defecation to investigate:      (A) Whether a self-administered, home-biofeedback training program with a new portable device     is as effective as office-based biofeedback therapy in improving i) physiology- dyssynergia     (defecation index), and ability to expel simulated stool, and ii) symptomatology-     satisfaction with bowel function, number of complete spontaneous bowel movements, stool     consistency, straining and quality of life.      (B) Whether home-training is more cost-effective than office-based biofeedback training.   "
6359|NCT03202641|"     The goal of this interventional crossover study, in intubated and mechanically ventilated     Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive     end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas     exchange, changes in aeration and distribution of ventilation and its impact on cardiac     function , specially the right heart (RH). The PEEP titration techniques are : incremental     PEEP titration(PEEPinc) and Lung recruitment maneuver plus incremental (LRM plus PEEPdec).   "
6380|NCT03202368|"     This is a multicenter, interventional, open-label, long-term extension study of Study WA28119     (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who     subsequently have flare or persisting disease activity. A maximum of 11 participants from six     centers in France that participated in the WA28119 study will be enrolled. The entire study     duration is anticipated to be approximately 160 weeks.   "
6381|NCT03202355|"     The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate     of tooth movement during alignment for Subjects receiving fixed appliance orthodontic     treatment.   "
6350|NCT03202758|"     Colo-rectal cancer is still one of the leading causes of cancer death worldwide. In France,     approximately 40 500 new cases are diagnosed each year. With more than 17 500 deaths in     France in 2011, colo-rectal cancer is responsible for more than 12% of all cancer deaths, the     overwhelming of deaths occurring in patients with metastatic disease.      Many studies highlight the fact that colo-rectal cancer has immunogenic properties and that     host immune responses can influence survival. Recent data have provided a clearer     understanding of the factors limiting the antitumor immune response in colo-rectal cancer.     One of the most critical checkpoint pathways responsible for mediating tumor-induced immune     suppression is the programmed death-1 (PD-1) and PD ligand 1 (PD-L1) pathway.      PD-1 is expressed on activated immune cells and can link to PD-L1 express on     Antigen-Presenting-Cell. Usually, this pathway is involved in promoting T-cells tolerance and     preventing tissue damage in settings of chronic inflammation. In pathological context, the     PD-1/PD-L1 pathway contributes to immune suppression and evasion. Many human solid tumors     including colo-rectal cancer express PD-L1, and this expression is associated with a worse     prognosis. The interaction of PD-1 with the ligand PD-L1 inhibits T-cell proliferation,     survival, and effectors functions; induces apoptosis of tumor-specific T cells; promotes the     differentiation of CD4+ T cells into immunosuppressive regulatory T cells; and increases the     resistance of tumor cells to cytotoxic T lymphocytes attack. Thus, the blockage of the     PD-1/PD-L1 interactions represents a logical target for cancer immunotherapy and in     particular colo rectal cancer immunotherapy strategy.      Preclinical studies have shown that PD-L1 blockade improves the immune response by restoring     T-cell effectors functions. Recent work in two in vivo tumor models shows a strong interest     in using an anti-PD-L1 in combination with standard treatment of colo-rectal cancer (FOLFOX).     In these models, the survival of mice that are treated with the combination therapy reached     40% when no mice were alive with FOLFOX treatment alone. This result may be explained, in one     hand by cytotoxicity of 5FU and in the other hand by the restoration of anti-tumor immune     activity of anti-PD-L1. These results suggest that the combination of chemotherapy with     immunotherapy would act synergistically in patients with colo-rectal cancer.      Research Hypothesis: Combination of chemotherapy (FOLFOX) with immunotherapy association     (anti-PD-L1 + anti-CTLA-4) would act synergistically in patients with colo-rectal cancer.   "
6371|NCT03202485|"     To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical     Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high     myopic astigmatism.   "
6443|NCT03201536|"     Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site,     non-blinded, randomized controlled, study designed to evaluate user preferences associated     with use of the zipline 3 system versus conventional suturing for incision closure.   "
6352|NCT03202732|"     The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes     care compared to standard care in relation to patient involvement and relevance for specific     group of persons with T1DM.      The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of     patient in-volvement, improved glycaemic control and a decrease in total number of     consultations compared to standard care. Furthermore, the investigators aim to identify if a     specific sub-population within the T1DM population will benefit significantly from the     intervention.   "
6353|NCT03202719|"     This is an open-label randomized phase IV clinical trial assessing immunogenicity of     poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months     of age. The study will recruit 1645 participants in five arms.   "
6354|NCT03202706|"     Obesity is associated with hyperactivation of the endocannabinoid system, and its inhibition     by the administration of CB1 receptor (CB1R) antagonists, leads to a decrease in food intake,     weight loss and an improvement in metabolic parameters. Even though the reduction in food     intake following central CB1R inactivation seems to be the principal cause of weight loss and     the improvement in metabolic parameters, several studies in animals and humans have indicated     that peripheral CB1R could also be implicated in the regulation of glucolipid metabolism. As     a result, it has been suggested that the long-term beneficial effects of inactivation of the     endocannabinoid system are due to both central effects on food intake and peripheral effects     involving adipose tissue, the liver, skeletal muscle and the pancreas. It appears essential     to determine the role of CB1R located in peripheral tissues and in particular in adipose     tissue, which plays an active role in maintaining glucolipid homeostasis. The experiments     conducted in this project consist in studying in biopsies of abdominal subcutaneous fat     whether activation of adipocyte CB1R modifies adipocyte metabolism by determining the     mechanisms. The investigators hypothesize that activation of CB1R in adipose tissue will lead     to the stimulation of lipolysis dependent on the alteration of the insulin signal, and     therefore that inactivation of the endocannabinoid system by blocking peripheral CB1R could     constitute a therapeutic approach to improve obesity-related insulin resistance and     dyslipidaemia.   "
6355|NCT03202693|"     This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the     absorption, metabolism, and excretion patterns of a single dose of [14C] PA-824, and (2) the     pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled     PA-824 in healthy adult male subjects. Unlabeled PA-824 and [14C]-PA-824 will be administered     together in an oral-suspension formulation. Enrollment is planned for one dose group of 6     subjects. All 6 subjects will receive the same treatment.   "
6356|NCT03202680|"     The objective of this trial is to compare the effects of a healthy, lean beef diet and an     average American, United States Department of Agriculture (USDA) style diet, that is low in     saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for     diabetes mellitus.   "
6358|NCT03202654|"     The objectives of this trial are to assess the effects of corn oil and coconut oil on     low-density lipoprotein cholesterol (LDL-C) concentrations, and other aspects of the fasting     lipoprotein lipid profile, as well as insulin sensitivity and an inflammatory marker, in men     and women.   "
9722|NCT03158688|"     Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone     (Kd) in terms of progression free survival (PFS) in patients with multiple myeloma who have     relapsed after 1 to 3 prior therapies.   "
6360|NCT03202628|"     This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem     cell transplantation works in treating patients with multiple myeloma that has come back or     does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone,     before a stem cell transplant helps kill any cancer cells that are in the body and helps make     room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After     treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then     returned to the patient to replace the blood-forming cells that were destroyed by the     chemotherapy. Giving ixazomib citrate in addition to pomalidomide, dexamethasone, and stem     cell transplantation may work better in treating patients with relapsed or refractory     multiple myeloma.   "
6361|NCT03202615|"     130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic     anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the     outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University     Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer     generated random number table. Each of the 2 groups will receive 2 medication for 2 months     with specific instruction to increase iron absorption. One group named L will receive powders     of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous     sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume     (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin     concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment     period.   "
6362|NCT03202602|"     Continuous positive airway pressure (CPAP) is the first choice of treatment for moderate to     severe obstructive sleep apnea syndrome (OSAS). Although adherence is critical for achieving     a good treatment effect, and early intervention if treatment problems emerge is important for     achieving good adherence, information on patient compliance is usually based on assessment of     the first few weeks of treatment. Telemedicine technology allows for monitoring of CPAP     pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis and could     therefore be an option allowing for adequate support and quick response if a patient has     problems with the treatment. In addition, improving early experiences of CPAP, identifying     patients in need of more intensive support could potentially improve adherence but also     reduced cost of care, and increased patient satisfaction.      The proposed study will recruit 200 OSAS patients starting CPAP treatment; 100 patients     randomized to afterwards receiving telemonitoring in combination with telephone calls, and     100 patients randomized to receiving usual office visits. All patients will in addition     answer questionnaires on sleep and health, quality of life, and patient satisfaction after     the first CPAP information visit and then again after 6 months of treatment. At time of     follow-up all patients will also answer questionnaires on side effects of CPAP. Health     economic variables will also be measured throughout the testing period.      The study will provide valuable information regarding benefits of telemonitoring in clinical     work with CPAP therapy. Implementation of telemedicine-based monitoring of CPAP therapy may     be an important part of increasing adherence among patients but also in the development of a     more cost-effective care as it can provide clinics with increased treatment capacity and     follow-up of both new and established patients. It would further improve the care for these     patients who often have a lifelong treatment, which aims to reduce the risk of developing     cardiovascular disease or premature death.   "
24038|NCT02971020|"     The investigators are conducting a pilot study to compare cognitive outcomes among Veterans     with severe aortic valve stenosis who are scheduled to undergo either aortic valve     replacement.   "
6363|NCT03202589|"     Hip fracture is the second indication of surgical management elderly patients. It remains     linked with a one-year mortality of 20%-25% according to diiferent governmental agencies, and     the incidence reaches 30% for those over 80 years old.      The factors recognized and found to be most correlated with the survival / mortality ratio of     patients are age, sex, intervention time, and prior health status.      The aim of a preoperative clinical evaluation is to estimate the benefit-risk balance of     different clinical and technical managements and to prepare the postoperative patient     outcome. During the last decade, management of hip fracture has improved mainly due to the     different recommendations for a multidisciplinary management of perioperative procedures.     However, none of them have yet highlighted FOCUS echocardiography as a routine examination     of the preoperative evaluation as in most noncardiac surgeries.      The objective of this study is to evaluate the preoperative management of these patients:     Clinical and biological evaluation, and to analyze the place that would have the FOCUS     preoperative echocardiography in the choice of the anesthesia technique resulting from the     patient evaluation.That study in a pre-requisite study to evaluate the incidence of FOCUS     echocardiography realized by anesthesiologists in the preoperative period in order to define     patient's outcome and anesthetic management.   "
6364|NCT03202576|"     This study evaluates the use of tape to secure nasogastric tubes compared to securement with     a nasal bridle device.   "
6365|NCT03202563|"     The objective of this study is to evaluate the efficacy on glycemic variability and safety of     gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin     10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on     metformin alone or diabetes medication naïve patient   "
6366|NCT03202550|"     This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will     be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on     pain scores during cervical dilator placement prior to dilation and evacuation (D&E).   "
6367|NCT03202537|"     The prevalence of gastroesophageal reflux disease is estimated to be as high as 20% in the     United States, and up to 50% of these patients remain symptomatic on proton pump inhibitor     (PPI) therapy. Unfortunately, the clinical approach to understand the mechanism of     nonresponse is not standardized, and patients will often undergo various esophageal function     tests: 1) pH-impedance, 2) wireless pH monitoring over 96 hours, 3) high-resolution impedance     manometry (HRIM), and 4) mucosal impedance. Currently significant controversy exists     regarding the best technique, optimal study protocol and treatment approach for the PPI     non-responder (PPINR) group, resulting in inappropriate resource utilization and a failure to     provide effective personalized care. As such, PPINRs contribute to a large healthcare burden     in the United States.      The first aim of the study is to identify the relevant physiologic parameters of the     aforementioned diagnostic tools in their ability to predict PPI requirement. Subsequently, in     Aim Two, these results will be applied to guide the formal development of a clinical     algorithm for the management of PPINRs with personalized clinical pathways based on mechanism     of treatment failure.      The investigators will first perform a prospective comparison trial of 240 PPINR subjects at     two centers over a 4 year period. Subjects will complete symptom questionnaires and undergo     diagnostic testing (pH-impedance on PPI therapy, HRIM, 96-hthe wireless pH monitoring off of     PPI therapy and mucosal impedance). Those who have a positive pH study and/or resume PPI     therapy will receive escalation of acid suppression therapy with dexlansoprazole. Experiments     1a & 1b will compare the ability of 96-hthe wireless pH monitoring vs pH impedance to predict     PPI requirement and response to dexlansoprazole, respectively. Experiment 1c will explore     whether mucosal impedance is equivalent to 96-hthe wireless pH monitoring in predicting PPI     requirement. Lastly, Experiment 1d will determine whether HRIM metrics can be utilized to     determine reflux burden, mechanism and response to treatment. Next, the investigators will     develop quality measures for reflux testing in order to develop a simplified management     strategy for the PPINR group. The RAND/UCLA Appropriateness Methodology will be utilized with     an expert working group to develop formal validated quality measures for reflux testing based     on results from aim 1 in addition to the available literature & evidence. This will be     conducted over twelve months (years 4 to 5).   "
10347|NCT03150524|"     This is a randomized clinical trial of short-acting nimodipine versus twice daily extended     release verapamil to treat patients presenting with Reversible Cerebral Vasoconstriction     Syndrome (RCVS).   "
6369|NCT03202511|"     The study will be a randomized, open-label, cross-over clinical pharmacokinetic trial to     investigate a strategy for probenecid boosting in the setting of tenofovir disoproxil     fumarate (TDF)/emtricitabine (FTC) for HIV pre-exposure prophylaxis (PrEP). The study will be     conducted at the Indiana University Clinical Research Center. All samples will be processed     and the amount of tenofovir/FTC in plasma, blood, and urine, and tenofovir diphosphate and     emtricitabine in peripheral blood mononuclear cells will be determined using validated     analytical methods developed by the investigators at the University of Colorado. Probenecid     plasma and urine concentrations will also be measured using an in-house assay. Following     completion of the study, the secondary aim will be accomplished via analysis of selected     samples collected at baseline and following treatment. Those selected samples will be     assessed for urinary markers of proximal tubulopathy (urine total protein, albumin,     creatinine, phosphorus, retinol binding protein, and beta-2-microglobulin) and serum alkaline     phosphatase, osteocalcin, procollagen type 1 N propeptide, cystatin C, and creatinine to     determine if the probenecid boosting strategy does indeed lead to less potential renal and     bone toxicity.   "
6370|NCT03202498|"     In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut     into the blood and cause harm. This study looks into a new way to lower the leakage of     bacterial fragments into the blood.      Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have     the ability to bind these bacterial fragments and so confine them to the gut. The purpose of     this clinical trial is to test the product Yaq-001 for the first time in patients with     cirrhosis.      This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it     helps improve the overall health status of the cirrhotic patients.      Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis     for any cause. Only postmenopausal women or with surgical sterilisation are eligible.     Additional inclusion and exclusion criteria of medical nature will be determined with the     investigator at the screening visit, by means of standard care routines plus an additional     test to assess the bowel transit time.      Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001,     or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to     better understand how safe and tolerable Yaq-001 really is.      The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study     doctor 5 times. At all the visits the patients will undergo a routine physical examination,     electrocardiogram, collection of blood and urine samples. On three occasions the patients     will be asked to provide additional samples of blood, urine and stool for analysis outside     the hospital.      56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will     participate in this study.   "
6372|NCT03202472|"     This pilot clinical trial studies radiofrequency technology in locating non-palpable breast     lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip     in the breast lesion before surgery and using a handheld device to guide doctors during     surgery may improve surgical outcomes in patients with non-palpable breast lesions.   "
6373|NCT03202459|"     Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects     of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the     PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these     episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it     becomes important the adequate control of PONV, aiming at the satisfaction of the patient     with the procedure, lower costs for the health system as well as reduction of complications     in the postoperative period. This study aims to evaluate the association of gabapentin or     pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients     undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess     side effects.   "
6374|NCT03202446|"     Our study evaluates the use of Laser-Assisted Immunotherapy (LIT) plus placebo and LIT plus     low-dose cyclophosphamide versus that of Standard of Care in patients presenting with Stage     IIIA, IIIB or IV breast cancer.      One-third of enrolled patients will receive LIT plus placebo, one-third will receive LIT plus     low-dose cyclophosphamide, and one-third will be assigned to a control group that receives     Standard of Care.   "
6375|NCT03202433|"     Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.      This study has not been completed.   "
6376|NCT03202420|"     The purpose of this pilot proposal are the following: 1) to determine the feasibility and     acceptability of integrating the TOPS weight loss program into underserved populations     through an urban safety net clinic and 2) to gather preliminary data of weight change to     inform the design of a future randomized, controlled trial to determine the efficacy of the     TOPS program in safety net clinics.      To achieve these goals, the investigators will pursue the following Specific Aims:      Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into     an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and     retention/dropout rates) and focus groups.      Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and     acceptable to participants.      Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with     clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12,     26, and 52 weeks.      Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of     initial body weight at 12, 26, and 52 weeks, respectively.   "
6377|NCT03202407|"     Chronic Kidney Disease-Mineral and Bone Disorder  is a systemic disorder of mineral and     bone metabolism, due to chronic kidney disease that is manifested by either one or a     combination of the following :        1. Abnormalities of calcium, phosphate, parathyroid hormone or vitamin D metabolism        2. Vascular and/or soft tissue calcification.        3. Abnormalities in bone turnover, metabolism, volume, linear growth or strength. According          to glomerular filtration rate , Kidney Disease Improving Global Outcomesclassify chronic          kidney disease into 5 stages,stage 5 also known as End Stage Renal disease is defined as          glomerular filtration rate less than 15 ml/Min/1.73 m2, or the need for renal          replacement therapy for survival The kidney plays a major role in phosphate          homoeostasis. The kidneys excrete the total net amount of absorbed phosphate.Under          normal physiological condition phosphate is freely filtered through the glomerulus. The          majority (85-90%) of filtered phosphate undergoes tubular reabsorption primarily in          proximal tubules.      Progressive renal insufficiency leads to hyperphosphatemia, hypocalcemia, and secondary     hyperparathyroidism .      Hyperphosphatemia known as hidden killer in chronic kidney disease defined as an abnormally     high serum phosphate concentration of >1.46 mmol/L (4.5 mg/dL). Its long term complications     are renal osteodystrophy, hyperparathyroidism, and increased cardiovascular calcification     leading to increased mortality and morbidity .      High serum phosphate can interact with calcium to precipitate calcium phosphate salts in     non-skeletal tissues Calcification generally occurs in the blood vessels, heart valves,     myocardium, and other soft tissues .      Cardiovascular calcification is probably the main reason for the high prevalence of     cardiovascular diseases in chronic kidney disease patients Studies have shown that     hyperphosphatemia is associated with increased vascular stiffening and arterial and valvular     calcification This is postulated to be caused by elevated serum phosphorus promoting the     transformation of vascular smooth muscle cells into an osteoblast phenotype that can     mineralize These vascular calcification also lead to left ventricular hypertrophy by     decreasing vascular compliance . Poor control of mineral metabolism also has been associated     with functional and structural cardiac abnormalities Efforts to reduce morbidity and     mortality associated with Chronic Kidney Disease-Mineral and Bone Disorder are therefore     primarily directed at controlling hyperphosphatemia via diet, phosphorus binders, and     dialysis      Dialysis alone is inadequate in assisting hemodialysis patients to obtain and maintain normal     serum phosphate levels . So, other methods of achieving prescribed levels of serum phosphate     in hemodialysis patients include the use of phosphate binders and phosphorus dietary     restrictions.:      Phosphate binders have been approved by the Federal Drug Administration (FDA) for patients     treated with maintenance dialysis, and calcium-containing salts are used worldwide not only     for the control of hyperphosphatemia but also as a source of supplemental calcium. Several     calcium salts are commercially available, including calcium carbonate, calcium acetate, and     calcium citrate Sevelamer hydrochloride is a recently developed phosphate binder, which is a     quaternary amine anion exchanger without calcium or aluminum. Sevelamer is effective in     controlling hyperphosphatemia without increasing the calcium load in chronic hemodialysis     patients In addition to its effects on serum phosphorous levels, sevelamer has been shown to     decrease total serum cholesterol and low-density lipoprotein cholesterol and to increase     high-density lipoprotein levels . These effects may offer additional benefits in reducing     cardiovascular complications in patients with end-stage renal disease.      Controlling abnormal laboratory parameters such as calcium ,phosphate and parathyroid hormone     as well as preventing the progression of extraskeletal calcification is considered a major     component for prevention of the bone disease and other related morbidities and hopefully     mortality in chronic kidney disease patients   "
6378|NCT03202394|"     This Phase IIa pilot study is a placebo-controlled multicenter study to evaluate safety and     efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be     randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus     standard of care. The treatment will continue for up to 28 days. The study will enroll up to     60 adult ARDS patients in up to eight sites within USA.   "
6382|NCT03202342|"     The study will consist of five occasions with one week in between. BOLD signal intensity of     the hypothalamus will be measured using fMRI. Measurements will be done before and after     drinking 300 ml plain water or water to which glucose and/or ethyl butyrate will be added.   "
6383|NCT03202329|"     Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery     will be randomized to receive either standard post-operative care (surgeon has to ask     actively for specialist cardiological support) or a nurse-based heart failure management     (nurses provide week-day support every day after surgery, if needed together with a heart     failure doctor)   "
6384|NCT03202316|"     The goal of this clinical research study is to learn if the combination of atezolizumab,     cobimetinib, and eribulin (ACE) can help to control inflammatory breast cancer that is     metastatic (has spread). The safety of this drug combination will also be studied.   "
6385|NCT03202303|"     This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with     ASD.   "
6386|NCT03202290|"     The prevalence of people suffering from gambling disorder is relatively high, and the impact     on this disorder the individual and those around him is considerable. The etiopathogenic     model of gambling disorder is multifactorial, involving various risk and vulnerability     factors, involved in the initiation and maintenance of the disorder. Among these factors,     neurocognitive alterations associated with the disorder has recently aroused interest among     researchers. In this study, the investigators propose to explore the neurocognitive     impairments of patients suffering from gambling disorder compared to a control group, in     order to identify alterations that could be the target of cognitive remediation programs.     Gambling disorder provides a unique opportunity to study the specific neurocognitive     impairments of the addictive process because it is not biased by the neurotoxic effect of     substances as it is the case in substance use disorders.   "
6387|NCT03202277|"     Type 2 diabetes (T2D) is a national epidemic and current lifestyle programs and medications     are not effectively managing the crisis. This project aims to test a novel     smartphone-delivered intervention that simultaneously targets multiple health behaviors     (i.e., sleep, sedentary behavior, physical activity,dietary intake) within clinical settings     at a large Veteran Health Administration regional hospital. If effective, this project has     potential for large-scale implementation nationwide through the VA healthcare system and     broad applicability for other populations at T2D risk as well as other disorders.   "
6401|NCT03202095|"     The investigators hypothesize that the administration of a widely available, naturally     occurring dietary supplement, creatine monohydrate, will reduce the severity of depression in     individuals with type 2 diabetes. The purpose of this study is to determine whether 12 weeks     of creatine supplementation is an effective treatment for depression in individuals with type     2 diabetes.   "
6414|NCT03201926|"     Malnutrition in cancer patients continues after surgery and worsens the patient's overall     health and quality of life. Previous studies reported edible insects in patients' diets     increased postoperative muscle mass and weight gain. Therefore, by using nutritionally     excellent mealworms for a long time, it is proved that nutritional status and survival rate     are improved, leading to development of various products of edible insects.   "
6388|NCT03202264|"     Medication side effects and interactions between medications are very common in older adults     and are related to negative health outcomes, including mobility. In this study, the     investigators will test a new process aimed at reducing unnecessary medication use and drug     side effects in seniors using the best medical evidence and patient preferences for     treatment. This study will assess how feasible the implementation of this intervention is     within a long-term care facility as well as if it is possible. The study will also assess for     any signals of reversal of medications related mobility impairments to reduce     medications-related mobility impairment (fatigue, pain, falls) using the intervention.     Participants in two long-term care facilities will participate in this study. Measures will     include feasibility outcomes regarding the logistics of the intervention as well as patients     outcomes (falls, hospitalizations, and medications) collected before and after     implementation. Findings will inform the design of a randomized controlled trial to test the     effect of this intervention on health outcomes.   "
6389|NCT03202251|"     Deep brain stimulation (DBS) is a neurosurgical procedure using a device that improves motor     symptoms of specific neurological and movement disorders such as Parkinson's disease or     Essential Tremor. As part of the patient's care, the DBS is implanted when symptoms cannot be     satisfactorily controlled with medications or conventional therapies. Lower urinary tract     symptoms are common in patients who have underlying neurological or movement disorders and     control over lower urinary tract function is poorly understood. In this study we are     evaluating the effects of DBS on lower urinary tract function.   "
6390|NCT03202238|"     Venepuncture can be challenging, especially in patients with co-morbidities that predispose     them to have inaccessible veins. Multiple unsuccessful venepuncture attempts compromise     patient care. It causes pain, delays in obtaining blood samples for investigations and     instituting intra-venous treatment.      Venepuncture assistive devices (VAD) include ultrasonography, and devices that utilize     infra-red or transillumination. These are expensive, not widely available, and have not been     rigorously proven to be effective. This preliminary study using an ordinary pen-torch for     transillumination showed promising results. 95% of patients with known difficult venous     access required two or less attempts for successful cannulation. It costs 35 times cheaper     compared to the cheapest VAD in the market. The concept is promising but the technique     cumbersome.      Building upon the concept of transillumination, the aim of this study is to develop an     idiot-proof cost-effective pocket-sized VAD (FireFly) to improve venepuncture success. A     randomized controlled trial (RCT) will be conducted to determine its safety and efficacy. Two     candidate prototypes will be modelled using Computer-Aided Design (Inventor®, Autodesk®,     California, USA) and fabricated using 3D-printing. Each prototype will be fitted with     light-emitting diodes of a specific wavelength (6500Knm, 4500Knm, or 660nm). Compared to     existing VADs, FireFly will be significantly smaller and lighter. It will be constructed     using nylon-based polyamide and silicone, with flexible circuitry. Flexibility allows it to     conform to the patients' limbs. A large transverse viewing window optimizes vein     visualization.      We include adult patients aged 21 to 100 with difficult venous access (history of ≥3     consecutive attempts required for successful cannulation during the current admission)     requiring non-emergent venepuncture in the RCT. Each patient undergoes venepuncture over the     upper-limb using one of the following: Veinlite® EMS (TransLite®, Texas, USA) (Control), a     commercial transillumination device; Prototype-1; Prototype-2; Conventional venepuncture     without an assistive device. Outcome measures include: successful cannulation within 2     attempts; duration of venepuncture; subjective user feedback. Fisher's exact and     Kruskal-Wallis tests will be performed.   "
6391|NCT03202225|"     While performing a primary TKA in consecutive patients, a constrained insert may be necessary     when adequate stability and soft tissue balance are not obtained. In this retrospective     study, The investigators aim to identify the prevalence and risk factors that associate with     the use of a constrained insert in primary TKA.   "
6392|NCT03202212|"     On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and     cardiovascular outcomes. Several potential candidates of these beneficial effects have been     explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on     different circulating mediators of vascular dysfunction.   "
6393|NCT03202199|"     The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict     resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation     therapy.   "
6425|NCT03201783|"     Information regarding the optimal timing for frozen-thawed embryo transfer (FET) following a     stimulated in vitro fertilization (IVF) is lacking. One option is to perform FET in the first     cycle following the stimulated IVF cycle, i.e. immediate transfer. Another option is to     postpone FET for at least one menstrual cycle, i.e. delayed transfer. This randomized study     aims to compare the ongoing pregnancy rate of immediate versus delayed FET following a     stimulated IVF cycle.   "
6394|NCT03202186|"     The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral     micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in     postmenopausal women. Three different doses of BHR-401 (200 mg, 300 mg or 400 mg) will be     tested against placebo in hierarchical order, starting with the highest dose. Superiority     will be defined as a significant (significance level α = 0.05) reduction of moderate to     severe VMS frequency compared to placebo at treatment week 12 (the primary efficacy endpoint     of the study).   "
6395|NCT03202173|"     To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human     nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.   "
6396|NCT03202160|"     Thyroid disorders are one of the most common endocrine problems in children and adolescents.     Diagnostic considerations can be approached from the perspective of the goiter.A goiter, or     thyromegaly, is an enlargement of the thyroid gland.Persons with enlarged thyroids can have     normal function of the gland (euthyroidism), thyroid deficiency (hypothyroidism), or     overproduction of the hormones (hyperthyroidism).   "
6397|NCT03202147|"     This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with     evidence of PSCI.   "
6398|NCT03202134|"     Patients get a general anesthesia for DIEPFLAP surgery. Depending on the attending     anesthesiologist an opioid based or an opioid free anesthesia is chosen. no randomization, no     blinding is done.      Retrospective outcome data are analyzed to improve further clinical care.   "
6399|NCT03202121|"     To analyze the relationship of nocturnal concentrations of melatonin, γ-aminobutyric acid and     total antioxidants with insomnia after stroke.   "
6400|NCT03202108|"     Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant     compliance, over a 7-day period, of Krio for the dietary management of participants with     intractable epilepsy or Glut-1 DS patients on a ketogenic diet.   "
6415|NCT03201913|"     Phase1 study of TTC 352 for treatment of metastatic ER+ breast cancer.   "
6402|NCT03202082|"     The present study aims to expand the evidence base of neuropsychological services in the     context of medical management of epilepsy, examining whether treatment outcome and patient     satisfaction with medical care are significantly improved when neuropsychological evaluation     is included as an additional component of medical care within a comprehensive epilepsy     center. All participants will complete an initial survey and a follow-up survey regarding     views towards their epilepsy treatment. Participants will be randomized into one of two     groups. One group will be given a neuropsychological battery in addition to the survey. The     primary study hypothesis is that the addition of neuropsychological services to     treatment-as-usual will result in significant improvements in (a) satisfaction with medical     care, (b) patient perceived treatment outcome, and (c) physician-rated medical compliance.     The secondary hypothesis is that participants who undergo neuropsychological evaluation will     be generally satisfied with their experience with neuropsychological services.   "
6403|NCT03202069|"     The purpose of this study is to determine the effects of daily protein intake patterns on     body composition and eating behaviors during weight loss.   "
6404|NCT03202056|"     Dry needling is a new treatment technique, addressed to mechanical pain of the     neuromusculoskeletal system. Recent investigations has developed new hypothesis about the     etiology of the osteoarthritis and could be in relation to musculoskeletal disorders, but     there is no published studies evaluating the results of this technique in hip osteoarthritis     patients.      The objective of this trial is to evaluate if dry needling is more effective in symptoms,     function, range of motion, strength, muscular length, pain threshold and compared to sham dry     needling and control.      For this purpose the investigators conduct a randomized controlled trial double-blind     (patient and examiner). The investigators included patients diagnosed of hip osteoarthritis     Grade I-III by Scale of Kellgren and Lawrence.      Patients included are randomized into 3 groups one receive Dry needling, other sham dry     needling and the other is a control. Groups receive 3 treatment sessions.      The variables are measured at the beginning and end of treatment. And also some variables are     measured before and after each session. Patients who participated in sham dry needling or     control group, when the intervention finish the investigators will be given the opportunity     to receive the actual technique.   "
6405|NCT03202043|"     This study is designed to see if drinking a tomato-based vegetable juice will increase skin     carotenoids.   "
6406|NCT03202030|"     This randomised controlled trial compares the immediate dentoalveolar restoration and bovine     demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A     total of 34 patients will be included and followed clinically and radiographically for 18     months. Patient centred outcomes will also be evaluated.   "
6407|NCT03202017|"     The purpose of this study is to investigate the effects of two treatment techniques called     Expiratory Muscle Strength Training (EMST) and Lung Volume Recruitment (LVR) on breathing,     swallowing, speech, and cough function in persons with mild to moderate ALS. Half of the     participants will do EMST alone, and the other half of the participants will do EMST and LVR.   "
6408|NCT03202004|"     This study will evaluate the efficacy and safety of GSK2894512 cream for the topical     treatment of plaque psoriasis (psoriasis) with its vehicle cream. This is a randomized,     double-blind, vehicle-controlled, parallel-group, multicenter study in adults with psoriasis.     The aim of this study is to show superiority of GSK2894512 over vehicle by comparing their     response rates. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks     blinded treatment, and 1 week post-treatment follow-up period. Subjects will apply randomized     study treatment to all psoriasis lesions once daily for 12 weeks. Subjects will be stratified     by Baseline physician global assessment (PGA) category (PGA score=2, PGA score >=3) at     randomization. Approximately 120 subjects will be randomized into the study of which 80 will     receive GSK2894512 1% cream and 40 will receive vehicle cream. Total duration of a subject's     participation in the study will be approximately for 14 to 17 weeks.   "
6409|NCT03201991|"     The purpose of this study is to determine the muscle strength of a muscle in the thigh after     12 weeks of home exercise.   "
6410|NCT03201978|"     GSK2894512 (trans-isomer) is a fully synthetic, non-steroidal anti-inflammatory agent. This     study is being conducted to evaluate the PK, safety and tolerability of GSK2894512 cream, 1     percent administered topically to healthy adult subjects. PK parameters obtained in this     study will be used to support the design of future maximum use PK (MUPK) studies in subjects     with atopic dermatitis (AD) and plaque psoriasis or psoriasis (PSO). This is a phase 1,     randomized, double-blind, vehicle-controlled, 3-period, sequential, inpatient study consists     of a Screening visit, 3 treatment periods and a follow-up visit. GSK2894512 cream, 1 percent     (or matching vehicle) will be administered sequentially in the treatment periods. Period 1     will include once daily repeated topical applications on approximately 5000 centimeter (cm)     ^2 intact non-occluded skin area for 21 days. Period 2 will include once daily repeated     topical applications on approximately 5000 cm^2 intact occluded skin area for 21 days. Period     3 will include a single topical application on up to 400 cm^2 gently taped-stripped skin     area. Each treatment regimen will be followed by washout period for approximately 21 days,     except for Treatment Period 3. Approximately 26 healthy adult subjects will be enrolled in to     the study. Total duration of participation in this study will be approximately 18 weeks.   "
6411|NCT03201965|"     The purpose of this study is to evaluate the efficacy and safety of daratumumab plus     cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in     treatment of newly diagnosed AL amyloidosis participants.   "
6412|NCT03201952|"     This project will evaluate distal intestinal bile salt administration in humans by deliving     ursodeoxycholic acid (UDCA) into the terminal ileum of subjects with a pre-existing ileostomy     and assessing several hormone levels following an oral glucose tolerance test compared to a     placebo.   "
6413|NCT03201939|"     In this study, the Investigators plan to determine the optimal means to prevent or slow the     progression of kidney disease among genetically at-risk northern Nigerian HIV-infected     adults. Based on data from studies of diabetic kidney disease that used medications that     block the renin angiotensin aldosterone system (RAAS), we plan to evaluate whether or not     RAAS inhibition (using a widely available medication that blocks RAAS) in HIV-infected adults     produces similarly promising results.   "
6416|NCT03201900|"     This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period     in untreated participants with partial onset seizures (POS).   "
6417|NCT03201887|"     Performance Validity Tests (PVTs) are widely used for the detection of sub-optimal effort and     malingering in neuropsychological assessments. Threats to their validity however likely to     intensify with time (e.g., information available on the web or from legal representatives)     and may lead to a decline in their ability to differentiate between malingerers and     non-malingerers. Eye movements and response time (RT) are less obvious outcome measures and     under less conscious control than more conventional PVT indices (e.g., accuracy). They are     therefore promising measures that can aid in detecting malingering when used in conjunction     with more conventional PVT indices. The Word Memory Test (WMT) is a widely used PVT in     neuropsychological evaluations. As part of the proposed study, TBI patients, chronic pain     patients and healthy adults (60 in each group) will be randomly divided to one of two     conditions; optimal effort or sub-optimal effort (participants will be asked to play a TBI     patient who wishes to present himself as having cognitive deficits or exaggerate existing     cognitive deficits). The proposed study will improve the WMT's efficacy in detection of     sub-optimal effort in neuropsychological evaluations and therefore protect its validity from     future threats. In addition, the proposed study will provide us with better understanding of     the effect of TBI on eye movements and RTs in general.   "
6418|NCT03201874|"     The project will test a tailored web and smartphone-based application (iCanCope with SCD) to     improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease.     The program will include goal setting, peer-based social support, and pain self-management     training. The investigators will determine initial program effectiveness through a pilot     three-site randomized controlled trial in 160 youth randomized to treatment compared to     attention control.   "
6419|NCT03201861|"     The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based     regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer     .   "
6420|NCT03201848|"     This is a multisite, double-blind, randomized, placebo-controlled, and parallel study     designed to evaluate the clinical efficacy and safety of Huaiqihuang granule for treatment to     children with chronic primary immune thrombocytopenia (Qi Yin deficiency).   "
6421|NCT03201835|"     Fifteen (15) healthy male volunteers will receive, following an overnight fasting and a     standard breakfast, a single dose of either one of five different administrations.Subjects     will undergo screening procedures within 21 days prior to first dosing. Eligible subjects     will be admitted to the Clinical Research Center (CRC) in the evening before each study drug     administration and will remain in-house for 24 hours after dosing. Following an overnight     fast of at least 10 hours, the subjects will receive a standard meal within 30 minutes prior     to dosing. Blood samples for PK will be drawn at specified time points. An End-of Study     (EOS)/Safety Follow-up visit will take place on 7-10 days after the last dose of study     treatment.   "
6422|NCT03201822|"     A randomized, double-masked and cross-over dietary intervention study in healthy young adult     males to evaluate the concentration of F-derived metabolites in plasma and urine after single     acute intakes of F-containing drinks on four different test days.   "
6423|NCT03201809|"     This study investigates the use of post-operative on-Q pain catheters for tissue expander     based breast reconstruction, versus conventional ultrasound-guided blocks placed     pre-operatively.   "
6424|NCT03201796|"     The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to     levofloxacin in the treatment of patients affected by CBP.   "
6426|NCT03201770|"     The study is to be performed in public health facilities in Central and West Africa where     Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat     episodes. The study is to assess the safety of Pyramax, particularly in patients with     underlying liver function abnormalities, in patients who have co-morbid conditions, such as     HIV, and also in very small children (<1 year of age).   "
6427|NCT03201757|"     This study will evaluate the long-term safety, tolerability, and durability of treatment     effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I     disorder   "
6428|NCT03201744|"     The proposed study aims to assess the effect of different levels of muscle relaxation on the     success of low-pressure insufflation, surgical conditions and patient recovery following     laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will     be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.      Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on     the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures     will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions     will be serially performed during surgery on an established visual scale. If conditions are     deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up     to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each     procedure, and the ability to perform low-pressure laparoscopic VHR.      Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to     maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be     considered successful when scores are maintained at 4 or 5 throughout the duration of the     procedure. Outcome for this aim will be the mean score for surgical condition assessment for     each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be     used as a surrogate of good visualization).      Specific Aim 3. Assess patient recovery with low and high insufflation pressures during     laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication     requirement, PONV incidence and severity will be assessed in multiple time points following     surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue     score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey.     Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.   "
6429|NCT03201731|"     Although psychotic disorders such as schizophrenia usually present in late adolescence or     early adulthood, research suggests that a substantial subset of people are diagnosed for the     first time after the age of 60. This condition is referred to as 'very late-onset     schizophrenia-like psychosis' (VLOSLP). People with VLOSLP are thought to experience high     levels of social isolation, yet there has been little research systematically examining this.     Additionally, little is known about how lonely people with VLOSLP feel, or how this group     relate to and perceive other people.      This study aims to examine levels of social isolation and loneliness in patients with VLOSLP.     The investigators also aim to explore aspects of social cognition in relation to VLOSLP.      A case-control study design will be used to examine the relationship between VLOSLP,     loneliness, social isolation and social cognition. The case group will be people diagnosed     with a non-organic psychotic disorder after age 60. The comparison group will be those aged     60 and above in contact with mental health services for a mental health difficulty, except     from a psychotic disorder or dementia.   "
6430|NCT03201718|"     Post-marketing surveillance study to evaluate the real world safety and effectiveness of     Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a     normal, routine treatment practice by Korean patients with Hepatitis C.   "
6431|NCT03201705|"     Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic     pain in Failed Back Surgery Syndrome with associated legs and/or low back pain. The waves     used in Spinal Cord Stimulation are mainly Tonic or Burst. Both Tonic and Burst stimulation     offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS.     The aim of our study is to evaluate the efficacy of a new stimulation paradigm with the     combination of the two wave forms.   "
6432|NCT03201692|"     Balance and gait problems in subjects with neurological disease lead to reduced mobility,     loss of independence and frequent falls. Treadmill training is a widely used form of     treatment and it has been used in subjects with neurological disease to ameliorate walking     and balance deficits. The Virtual Reality Treadmill as a therapeutic tool has been recently     introduced to practice gait adaptability elicited by aligning foot placement relative to the     projected visual context.      Forty-eight subjects with neurological disease will receive treadmill training treatment     randomly divided in Traditional Treadmill training and Virtual Reality Treadmill training.      The aim of this randomized controlled study is to assess whether Treadmill training with     Virtual Reality is better than Traditional Treadmill training in improving dynamic balance     and cognitive aspects in subjects with neurological diseases.   "
6433|NCT03201679|"     The worldwide occurrence of hip fracture is high with an annual incidence of approximately     100 per 100.000 people. Mortality for patients undergoing hip fracture surgery is high with a     30-day mortality rate varying between 4.5 and 13.3 %. It is agreed that non-modifiable     factors such as age, gender and pre-existing comorbidities contribute to early death of hip     fracture patients. However, not many studies have focused on preoperative sepsis as a     potential risk factor. Hip fracture patients are commonly identified with sepsis after     surgery, but the extent of preoperative sepsis and its consequences are sparsely elucidated.     Being able to identify patients at higher risk of postoperative mortality could potentially     improve outcome and extensive hospital registries of vital signs and cultures allow     identification of preoperative sepsis.      The aim of this study is to assess the association between preoperative sepsis and the 30-day     mortality after hip fracture surgery.   "
6434|NCT03201666|"     This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal     diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted     the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and     maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden     standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing     chromosomal anomalies.   "
6435|NCT03201653|"     Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to     60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the     most common complications after DP (12% to 40%). POPF after DP is also associated with major     complications such as bleeding or septic shock and remains an equivocal problem. However, all     the previous reports were retrospective review, non-randomized study, or individual     experience and showed no significant improvement of overall POPF. As always, this issue     remains in obscurity and seek for a more concrete evidence to solve.   "
6491|NCT03200912|"     The objective of this study was to evaluate the safety and therapeutic equivalence of generic     ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic     comparability of the two active products and the superiority of the two active products over     the vehicle gel in the treatment of AK on the face and scalp.   "
6436|NCT03201640|"     All of the tools currently available for preoperative preparation of children either use a     third person approach (i.e., use media whereby they watch a video or look at pictures of     another child receiving an anesthetic), provide tours at some time previous to the operation     date, or are shown the equipment that they will encounter during their anesthetic. No     preoperative programme currently allows the child to experience the entire chain of events     from leaving the preoperative preparation area (and their parents), walking to the operating     area, being initially prepared for and receiving anesthesia and recovering from anesthesia,     in real time and from a first person perspective. As such the investigators are carrying out     this study to assess whether virtual reality preoperative preparation is effective in     reducing anxiety at induction of anesthesia.   "
6437|NCT03201627|"     This study is planned to study whether lithium carbonate has protective effect on the brain     of Niemann-Pick disease type C1.   "
6438|NCT03201601|"     The aim of the present study is to evaluate the effect of increasing the proportion of     D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in     women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly     take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of     D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of     D-chiro-inositol.   "
6439|NCT03201588|"     The study is a Randomized Intervention, Multi-Center Study to Determine the Role of Fatty     Acids in Serum and Breast Milk in preventing Retinopathy of Prematurity Subjects who meet all     inclusion and none of the exclusion criteria will be enrolled into the study. Upon entry into     the study, subjects will be randomized and given a unique subject number.      A randomized intervention study of 105+105 (number based on power analysis regarding up to     date ROP frequency, see 5.1 and 11.1) infants without major malformations born with a     gestational age less than 28 weeks + 0 days will be performed.   "
6440|NCT03201575|"     Septic shock remains a major public health problem in industrialized countries, with a     mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to     dysregulated inflammatory response, the pathophysiology of organ failures in septic shock     involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic     strategy for protecting organs against the detrimental effects of ischemia-reperfusion     injury.      The objective of the present study is to determine whether remote ischemic conditioning can     limit the severity of organ failure in patients with septic shock.   "
6441|NCT03201562|"     To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in     the treatment of early to moderate presbyopia.   "
6442|NCT03201549|"     The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21     levels in humans.   "
24837|NCT02960581|"     This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral     efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.   "
6444|NCT03201523|"     The purpose of this research study is to design, implement, and evaluate a community level,     socio-ecological based CVD prevention intervention using a participatory approach for women     in a homogeneous ultra-Orthodox Jewish Hasidic community in Israel. A quasi-experimental,     pre-post study design will be utilized, where all community participants will be exposed to     intervention components. Pre and post samples will be selected through randomized cluster     sampling of pre-existing community groups. It is hypothesized that ultra-Orthodox Jewish     Hasidic women exposed to this community intervention will have improved healthy eating     behaviors, reduced unhealthy eating behaviors, increased engagement in physical activity and     sleep, and reduced risk for obesity (weight, BMI).   "
6445|NCT03201510|"     This study aims to determine the feasibility of recruiting and retaining men who have sex     with men (MSM) in a multi-country prospective cohort study in preparation for human     immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).   "
6446|NCT03201497|"     the investigators aim to set up a multicenter registry study for severe PJP requiring ICU     admission. The purpose of this study is        1. to establish a prospective severe PJP registry about clinical characteristics,          laboratory and radiographic findings, critical care management and outcomes.        2. to explore the predictive factors associated with outcomes ;        3. to compare the difference between PJP patients with HIV and without HIV infection.   "
6447|NCT03201484|"     A study correlating patient reported outcomes measured by a validated tool with physical     measurements recorded by 3d photography of patients undergoing parotid resections   "
6448|NCT03201471|"     It's a prospective, single arm, open label phase II clinical trial, in which the safety and     efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have     received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed     positive results.      abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide,     etoposide, vincristine and prednisone.      PR: partial remission; MRD:minimal residual disease;   "
6449|NCT03201458|"     This phase II trial studies how well atezolizumab with or without cobimetinib works in     treating patients with bile duct cancer that has spread to other places in the body and     cannot be removed by surgery. Monoclonal antibodies, such as atezolizumab, may interfere with     the ability of tumor cells to grow and spread. Cobimetinib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cobimetinib     may work better at treating bile duct cancer.   "
6450|NCT03201445|"     The primary objective of this study is to evaluate the testicular safety of filgotinib in     adult males with moderately to severely active ulcerative colitis.   "
6458|NCT03201341|"     To accurately control body movements to interact with objects, our brain needs     representations of the body and the nearby space. The broader aim of this research project is     to study the behavioural and physiological mechanisms involved in the constitution of these     representations, to identify their neural bases, in order to better understand the     dysfunctions in the context of neurological or developmental disorders.   "
6550|NCT03200145|"     Cohort Observational Study. The study will assess differences in quality of life, well-being     and mood between persons living in a nursing home following usual care and persons living in     nursing homes following a centered person care model.      Initially, the follow up will last 6 months, with the possibility to be extended.   "
6451|NCT03201432|"     Stroke is one of the important causes of disability and death in the world, in which more     than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral     basilar artery system, especially when in the presence of extracranial proximal vertebral     artery stenosis. Vertebral artery stenting is a minimally invasive method for the     reconstruction of vertebral artery stenosis and the early clinical studies showed that it was     feasible, safe and effective, but the high rate of restenosis has become a bottleneck     restricting its development. Previous systematic review had suggested that the drug eluting     stent might reduce the incidence of restenosis of vertebral artery. However, prospective     randomized controlled trials comparing the efficacy of bare metal stents and drug eluting     stents on the prevention of restenosis remains absent.   "
6452|NCT03201419|"     The purpose of this trial is to investigate the efficacy, safety and tolerability of     different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of     treatment for nocturia due to nocturnal polyuria in adults   "
6453|NCT03201406|"     During 1993 and 2006, a total of 987 patients older than 20 years underwent native kidney     biopsy at the Renal Division of this hospital. 404 patients with membranoproliferative     glomerulonephritis and mesangioproliferative glomerulonephritis, and patients with secondary     glomerulonephritis or other renal pathologies, such as diabetic nephropathy, lupus nephritis,     rapid progress glomerulonephritis, acute tubular necrosis, and tubulointerstitial nephritis     will be analyzed. The demographic characteristics and laboratory data of these patients at     presentation or before renal biopsy will be recorded. These data included parameters such as     age, sex, diabetes, hypertension, immunosuppressants treatment, BUN, serum creatinine,     albumin, hemoglobin, total cholesterol, triglycerides, and urine protein. All subjects will     be followed until 2015 for occurrence of primary endpoints, including all-cause death or ESRD     requiring long-term dialysis or renal transplantation. A total of 433 patients who had been     followed for 3 years during 2003 and 2007 will receive regular clinic follow-up. GFR will be     estimated according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula:     186 x Scr -1.154 x age -0.203 x 0.742 (if female). CKD stage will be determined as described     by the National Kidney Foundation of the United States. At the time of entry, GFRs of 30-59,     29-15 and < 15 ml/min/1.73 m2 for more than 3 months will be classified as CKD stages 3, 4     and 5, respectively. Baseline Data of the 433 patients are used as recorded at the beginning     during 2003 and 2007. The observation period of each patient is defined to start immediately     after the registered measurement of serum creatinine satisfying the above criteria     (designated as the index date) and lasted until ESRD or end of 2015. ESRD is defined as     initiation of RRT, i.e. chronic dialysis or renal transplantation.   "
6463|NCT03201276|"     Glucosamine is an important part of the treatment strategy for osteoarthritis, but its     effectiveness is still controversial. To explain the efficacy differences of glucosamine, in     this study the investigators detect the concentration of glucosamine in the plasma and     synovial fluid, some effect indexes such as inflammatory markers and gene polymorphism of     glucosamine transporters. On the one hand, the investigators compare the plasma peak and     gluten glucosamine concentration and the concentration in synovial fluid among participants     to observe the individual differences of glucosamine exposure in vivo. On the other hand, the     investigators investigate the correlation between drug concentrations, effect index and gene     polymorphism. The hypothesis is that glucosamine exposure in vivo has individual differences     and gene polymorphism can explain this differences.   "
6454|NCT03201393|"     The investigational product is a combination of two re-purposed marketed drugs used for the     treatment of Chronic Low back Pain through the discovery of biologically and clinically     relevant affinity for new targets. Both drug are being re-purposed at a significantly lower     dosage compared to the maximum dosage that has already been approved for the marketed     indications.      The combination is a First-in-Class drug due its new and unique mechanism of action. This     non-narcotic product may provide a safer and more effective alternative to opioid     painkillers.      The investigators propose that in predisposed individuals, Chronic Low back Pain occurs due     to an exuberant innate immune system activation (to the detriment of the host) nearby spinal     nerve roots. The innate immunity activation leads to release of proinflammatory cytokines     [nitric oxide (NO), tumor necrosis factor-α (TNF-α), and reactive oxygen species (ROS)], and     to activation of COX-2. The resulting neuro-inflammation, triggers radicular pain along the     anatomical distribution of the spinal nerve roots. The investigators propose that exuberant     innate immune system activation is triggered by tissue injury nearby the spinal nerve roots,     (e.g., intervertebral disc pathology, or degenerative abnormalities of the spine).      Back pain becomes chronic when the immune system becomes stuck in fighting mode. ALLOD-2     reverses the neuro-inflammation through dual action, inhibition of release of     pro-inflammatory cytokines and inhibition of COX-2 activation. High efficacy for treatment of     CLBP and for treatment of migraine may suggest the product addresses the root cause of pain.   "
6455|NCT03201380|"     The prostate cancer is a heterogeneous disease the care of which varies according to the     status: localized, locally advanced, or in recurrence after local or metastatic treatment.     The precise evaluation of the degree of extension of the disease is thus essential because it     is going to allow to adapt at best the therapeutic strategy.      Contrary to the abdomino-pelvic scanning and to the osseous scintigraphy which(who) are a     member(part) of the balance assessment of standard extension of the prostate cancer, the     place of the Tomography with broadcast of Positrons to scan (TEP scan) in Choline in the     management of patients affected by prostate cancer is not clearly defined in the national and     European recommendations.      The current marketing authorization ( AMM) is the research for bones localizations in the     prostatic cancers at high risk. It indeed seems that this examination is more successful than     the standard radiological examinations (bone scintigraphy and abdomino-pelvic scanning) in     the detection of the bone metastatic hurts, with a sensibility of about 100 % and a precision     of the order of 93 % according to certain studies.      The recent data of the literature suggest a quite particular interest at the patients in     situation of biochemical recurrence in terms of localization of (or) tumoral site (s).      THE AMM however not specifying if this examination has to be made within the framework of the     initial balance sheet of extension, at the time of the biochemical second offense or at the     known metastatic stage, there is a big variability of the practices according to the centers.      The current indications being very ill-assorted, he is interesting being able to estimate the     heterogeneousness of the practices of way multicentre, by leading a study observationally     retrospective in region Provence-Alpes-Côte d'Azur (PACA).   "
6456|NCT03201367|"     Portal vein thrombosis (PVT) in patients with liver cirrhosis may be due to neoplastic growth     or non-neoplastic causes.        -  Treating PVT with anticoagulation in liver cirrhosis is difficult to be established but          may be of great benefit in acute symptomatic PVT.        -  The ultimate goal is complete recanalization of the portal vein without inducing major          bleeding, abnormal liver function tests or increased mortality.   "
6457|NCT03201354|"     The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to     lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the     subconjunctival space. The implant was developed in response to the need for more     straightforward, standardized and safe surgical technique than standard filtration surgery.     No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a     partial-thickness scleral flap. This may reduce surgical time and complications when compared     to a standard trabeculectomy.      In some studies it has been found to be safe and effective with few complications, even in     high-risk patients. No previous studies have compared filtration surgery with Ex-Press     implant to deep sclerectomy.   "
6459|NCT03201328|"     This is a prospective research study talking place at University hospital of Dijon and     requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants     and 10 patients with bilateral cochlear implants to carry out:        -  an audio-vestibular examination,        -  a videonystagmoscopic study,        -  a posturography study and        -  a movement study. The aim of the study is to evaluate the impact of binaural audition on          postural performance and orientation.   "
6460|NCT03201315|"     The aim of this quality control study is to describe the presence and intensity of     postoperative nausea and vomiting (PONV) and its correlation with intraoperative fentanyl     dosing. Additionally, the investigators will examine pain scores.   "
6461|NCT03201302|"     Bone mass develops throughout childhood and adolescence until a peak bone mass is achieved     during early adulthood. Fracture risk later in life can be predicted at a large extent by     peak bone mass. Occurence of sarcopenia and osteoporosis (i.e. loss of mone mass) during late     adulthood has been strongly associated with the degree of bone mineralization during early     life. Nearly 50% of total bone mineral content (BMC) reached during adulthood is obtained     during pre-adolescence rendering this period critical for skeletal health and is considered     as an optimal period for bone/skeletal growth since during this time bones are more adaptable     to osteogenic stimuli such as exercise-induced mechanical loading. Organized sport activities     and/or nutrition appear to affect profoundly bone mineral density (BMD), BMC, bone geometry,     and overall skeletal health during preadolescence offering an effective type of prevention of     osteoporosis, a condition very difficult to treat later in life. Evidence suggest that some     modes of exercise activities may be more effective (osteogenic) for bone development due to     the magnitude and type of mechanical strain placed on long bones causing them to be more     dense. Weight-bearing activities (e.g. running, jumping etc.) are believed to be more     osteogenic than non-weight bearing activities. However, more research is required in order to     determine: i) whether weight-bearing activities are more osteogenic than non weight -bearing     activities during childhood and ii) the osteogenic potential of a large number of sport     activities used by school-children as compared to a control treatment of no participation in     organized sport activities. The present trial attempted to compare a large number of     different sport activities in respect to their osteogenic potential based on training     variables that are thought to affect osteogenesis while at the same time allows direct     comparison of exercise modes that are entirely different. Therefore, the goal of this     investigation was to determine the osteogenic potential of a large number of exercise     training activities in boys and girls of 8-12 years of age during an entire primary school     season.   "
6462|NCT03201289|"     The purpose of this study is to measure MTWA in the patients undergoing cardiac surgery and     to investigate the relation between MTWA and adverse clinical outcomes.   "
26917|NCT02933398|"     A prospective, randomized, controlled trial including patients who are diagnosed with a small     renal mass (<4 cm) amenable to resection using either RALPN or LPN.   "
6464|NCT03201263|"     Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory     distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016).     Early implementation of a specific mechanical ventilation mode that enhances lung protection     in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a     tremendous impact on clinical practice.      Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to     assisted mechanical ventilation: improves oxygenation without increasing ventilation     pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory     drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity     of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure;     improves regional compliances. Thus, physiologic studies generated the hypothesis that     addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical     ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung     strain and stress through various synergic mechanisms potentially yielding decreased risk of     VILI, faster weaning and improved clinical outcomes.      The investigators conceived a pilot RCT to verify clinical feasibility of the addition of     Sigh to PSV in comparison to standard PSV.      The investigators will enrol 258 intubated spontaneously breathing patients with mild to     moderate AHRF and ARDS admitted to the ICU.      Patients will be randomized through an online automatic centralized and computerized system     to the following study groups (1:1 ratio):        -  PSV group: will be treated by protective PSV settings until day 28 or death or          performance of spontaneous breathing trial (SBT);        -  PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh          until day 28 or death or performance of spontaneous breathing trial (SBT).      Indications on ventilation settings, weaning, spontaneous breathing trial and rescue     treatment will be specified.   "
6465|NCT03201250|"     In the currently proposed phase I/II study, the investigators aim to treat patients with     relapsed and/or relapsed refractory Multiple Myeloma who have progressed on carfilzomib-based     therapy with an FDA approved c-MET inhibitor, cabozantinib.   "
6466|NCT03201237|"     To compared short- and long-time action observation training (AOT) in terms of grip strength,     the Jebsen Taylor Hand Function Test (JTHF), the Quality of Upper Extremities Skills Test     (QUEST), and the ABILHAND-Kids test.   "
6467|NCT03201224|"     In the complex process of organ transplant, two of the major steps are:        1. evaluation of the organs of potential donors in health institutions:        2. proposing grafts to the transplant teams, according to rules defined at the national          level.      In the absence of the possibility of transmitting the images between the deceased donor sites     and the transplant teams, the visualization of these examinations does not take part in the     decision-making of the transplant team. This leads in the displacement of the transplant team     in order to verify the grafts after acceptance of the graft proposal.      The Cristal Image project is a visualisation project for the transplant teams, in real     time, at the time of the proposal of the graft so that they can give an opinion (acceptance,     refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical     records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).      The hypothesis of the project is that the implementation of a secure image transmission     (complete anonymisation of the data of the donor) before the acceptance by the team, will     allow an optimization of the use of the qualified organs by reducing risks, unnecessary     displacement of transplant surgical teams, and securing the allocation of organs to recipient     patients.   "
6468|NCT03201211|"     The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the     antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71     years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously     exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a     0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received     saline placebo controls will also be included in this follow-up study to make comparisons     with the investigational vaccines. No vaccinations will be administered in this trial.   "
6551|NCT03200132|"     This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory     motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET)     images.   "
6469|NCT03201198|"     This study examines the effects of an exercise and behavioral program, called Active-Life, to     promote physical activity in people with chronic obstructive pulmonary disease. A sedentary     lifestyle is very common in older people with chronic disease and if this program is     successful it will be used to promote physical activity and improve the health of people with     chronic obstructive pulmonary disease.   "
6470|NCT03201185|"     The investigators aim to demonstrate that ramipril after transcatheter aortic valve     implantation has benefits in terms of prognosis, cardiovascular events and ventricular     remodeling (MRI).   "
6471|NCT03201172|"     The study is designed as a monocentric, prospective, observational, comparative follow-up     study based on two previously treated patient groups. The first group consists of patients     treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients     will be included in the study and analyzed. The final follow-up after 24 months has already     been documented by the study center. Compared to that, a consecutive series of 50 Univation®     X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to     include 80 retrospective patients for that historical control study design.      The products under investigation were used in routine clinical practice and according to the     authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use     will be documented in the Case Report Form (CRF).   "
6482|NCT03201029|"     As a physician, narrowing ones' practice to a particular pathology or group of people is     common. Dermatologists are able to concentrate within a number of different areas: cancer,     cosmetics, pediatrics or ethnic populations to name a few. Recently, there has been an     emphasis on developing skin of color (SOC) clinics and recruiting dermatologists who focus on     skin diseases that effect patients with skin of color. In this study, patients with SOC is     defined to encompass that of persons of African, Asian, Native American, Middle Eastern, and     Hispanic backgrounds. An emphasis on SOC benefits patients in a variety of ways: 1) these     dermatologists are trained to recognize pathology that may present differently, depending on     the Fitzpatrick skin type and ethnicity of the patient, 2) these dermatologists are trained     to address medical disparities that are present among patients with SOC, 3) these     dermatologists are trained to address culturally sensitive topics that may be common among     patients with SOC. Despite the growing number of SOC patients and the benefit that SOC     clinics provide, studies have not looked at the characteristics that influence dermatologists     to focus on SOC as opposed to other specialty areas. Therefore, we aim to identify     information that may influence dermatologists to focus on skin disease prevalent among     patients with SOC.      Currently, there are nine academic institutions with an Ethnic Skin Center in the United     States. Given the limited number of academic centers with a designated center focused on SOC,     a lot of care of skin of color patients happens in private practices. This is supported by     the fact that many of the members in the Skin of Color Society are dermatologists in private     practices. Thus, SOC clinic is defined broadly in our study to encompass not only academic     dermatologists but also private practice dermatologists who have special interest in care of     skin of color patients. Regardless of the type of practice, we hope to identify unique     characteristics of dermatologists focusing on SOC skin diseases.   "
6573|NCT03199846|"     This study will collect real-world data from advanced melanoma diagnosis through most recent     visit and data sourced from patient medical records following a 2-part study design     consisting of a random sample (Part 1) and an oversample (Part 2).   "
24838|NCT02960568|"     The investigator proposes to 2D6 (Cytochrome P-450 Isoenzyme 2D6) genotype and phenotype a     group of active duty service members and assess the effects on primaquine metabolism.   "
6472|NCT03201159|"     The study drug (VLX103) is being developed for the treatment of Alcoholic Steatohepatitis and     other liver diseases. Alcoholic Steatohepatitis is an inflammatory (associated with     irritation, swelling and cell damage) disease that affects the liver. It is associated with     heavy and chronic intake of alcohol and presence of fat in the liver. Signs and symptoms     often include fever, yellowing of the skin, nausea and impairment of liver function.      The main objective of this study is to evaluate the safety, pharmacodynamics (what the drug     does to the body) and pharmacokinetics (how the drug is handled by the human body, like     absorption and elimination) of increasing doses of VLX103 in subjects with moderate Alcoholic     Steatohepatitis. In other words, we will evaluate how your body tolerates VLX103 at a     specific dose and the effects that this VLX103 dose has on your liver and your body in     general. The secondary objectives of this study are to evaluate if VLX103 has the potential     to treat Alcoholic Steatohepatitis patients, to determine the maximum dose that can be     tolerated, and to measure the levels of VLX103 in your blood at different time points during     the study.      VLX103 is an experimental drug. Experimental means that the drug has not been approved by the     Food and Drug Administration (FDA) for the treatment of Alcoholic Steatohepatitis. The active     ingredient in VLX103, pentamidine, is approved for treating parasitic (microorganisms)     infections. Pentamidine is currently approved and marketed in about 20 countries, including     the United States, for use by injection (administered by a syringe) and by inhalation     (administered by a nebulizer) for other health conditions. However, VLX103 is the first oral     form of pentamidine being developed, and is administered by mouth as an oral tablet.   "
6473|NCT03201146|"     The purpose of this study is to evaluate the safety and clinical activity of Apatinib in     combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line     chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung     cancer(NSCLC).   "
6474|NCT03201133|"     Patellofemoral pain syndrome (PFPS) is a multifactorial pathology characterized by diffuse     retropatellar and peripatellar pain in the knee joint, exacerbated by overloading activities     on the patellofemoral joint. However, this disease showed high degree of patients not     responsive to therapeutic strategies. This condition occurred because several factors is     related to disease such as: (1) proximal factors (involving trunk and hip), (2) local factors     (surrounding and or within the patellofemoral joint) and (3) distal factors (involving ankle     and foot). Thus, the identification of clinical subgroups based in anatomic changes     (proximal, local and distal factors) is a recent strategy that could help in the therapeutic     strategies focused on the etiology of the disease, improve responsiveness to treatment,     clinical and functional benefits.   "
6475|NCT03201120|"     Phase 3b of the research will be a laboratory experiment that uses an experimental and     analytic design that is parallel to that used in Phase 3a, the online experiment. The primary     objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different     message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral     intentions and UV-related behavioral choices post-exposure. Including time for preparation,     viewing, and removal of the monitoring equipment, the message viewing session will take about     45 minutes per session.   "
6476|NCT03201107|"     To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls     and health in Spanish postmenopausal women   "
6477|NCT03201094|"     The study purpose is to investigate the hypothesis that in adults with SAH, early     neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will     improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls     receiving standard of care interventions for nutrition and mobilization. The investigators     will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment     as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH.     This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as     compared to age and severity-matched SAH patients undergoing standard of care interventions     for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and     NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of     this study will establish evidence for precision nutrition plus early exercise to mitigate     the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health     recovery outcomes.   "
6478|NCT03201081|"     Lack of physical activity is one of the major causes for obesity and functional disability in     the elderly. Including regular exercise in elderly´s lifestyle is not an easy task. The main     objective was to analyse the effect of a motivational resistance-training programme on     satisfying the individual´s psychological needs, level of self-determination and body     composition. A quasi-experimental study was performed with 47 volunteers (29 females, 18     males) of 67-75 years of age, divided into two groups: experimental (n = 27) and control (n =     20). A 12-week intervention programme was performed, with a total of 36 sessions.   "
18790|NCT03039621|"     The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in     the treatment of acute respiratory viral infections in children aged from 6 months to 6     years.   "
6479|NCT03201068|"     This study will define the impact of a probiotic supplement on microbiome, immune system, and     metabolic syndrome. This study will determine the degree to which a probiotic supplement can     1) improve metabolic markers and metrics of metabolic syndrome, 2) alter microbiota     composition and function, 3) impact microbiota metabolites, short-chain fatty acids—potential     normalizers of metabolic and immune dysfunction, and 4) regulate immune status and function     including reducing chronic, systemic inflammation as assessed by high dimensional immune     profiling.   "
6480|NCT03201055|"     This study will aim to assess the acceptance of the Snore PAP system as a treatment concept     for snore. The study will subjectively assess participant and bed partner acceptability and     usability of the Snore PAP system and objectively assess participant compliance with the     Snore PAP system.   "
6481|NCT03201042|"     To establish performance of individual tests and combinations of tests (serological,     molecular and cellular tests) in early Lyme infection diagnosis   "
6553|NCT03200106|"     Treatment of malignant ascites with the alfapump offers a new treatment option for this     patient group. So far, there is no systematic analysis of patients with this indication     available in the literature.      This retrospective analysis offers the possibility to assemble already existing data within a     reasonably short time frame. Based on this analysis, a prospective analysis can be designed.   "
6483|NCT03201016|"     Osteoporosis is a common complication in chronic liver disease, especially in the late stages     of the disease. Good nutrition and calcium and vitamin D supplementation are recommended for     the prevention and treatment of osteoporosis. There are no specific guidelines for its     pharmacological treatment, but bisphosphonates have been shown to be effective in increasing     bone mass in patients with chronic cholestasis, with a good safety profile.      There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis     (except for primary biliary cholangitis (PBC)). There are no clear recommendations for     osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention     before the onset of the complications derived would significantly improve the quality of life     and decrease the morbidity and mortality associated with osteoporosis and fractures      Objective:      -To assess the prevalence of osteoporosis and fragility fractures in patients with liver     cirrhosis in our country and the risk factors associated      Method:      Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child     stage during a hospital admission. Epidemiological, demographic, clinical, analytical and     imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score)     will be evaluated. A descriptive statistic of the main variables will be carried out as well     as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or     fragility fractures   "
6484|NCT03201003|"     The purpose of this study is to demonstrate the efficacy and safety of AR101 through     characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children.   "
6485|NCT03200990|"     The objective of this study is to determine ventricular loading conditions during and after     PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors     and cardiac enzymes. These specific patterns are so far unknown and will be compared with the     validated FDA-cleared and CE marked Impella CP. Ten cases with Impella CP will be performed     in this study to obtain the exact same measurements for comparing purposes.   "
6486|NCT03200977|"     An observational database analysis, using existing data of patients diagnosed with Classical     Hodgkin Lymphoma.   "
6487|NCT03200964|"     Database registering demographic patient data, anesthesia and surgery information, post     operative recovery and complications if any.   "
6488|NCT03200951|"     Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for     detecting intracranial hypertension. The aim of this study is to evaluate the effect of     epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing     osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural     block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20).     Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine     for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15%     ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve     sheath diameter after epidural block measured by optic nerve ultrasonography between groups.   "
6489|NCT03200938|"     Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two     techniques is established.   "
6490|NCT03200925|"     The main purpose of this study is to determine the effect of prenatal video education on     pregnant women's intention to practice and actual practice of skin to skin contact (SSC)     after birth. This study hypothesizes that education in video format will increase patients     knowledge about skin to skin in a way that will make them consider participating in skin to     skin immediately after birth.      Therefore the end point for this study is intention to participate in SCC measured by a     single questionnaire item Do you plan on participating in skin to skin (or kangaroo care)     immediately after birth? Our secondary end-point will measure whether or not the patient was     able to participate in skin to skin within five minutes of delivery.      All study participants will complete a short survey about their intention of practicing skin     to skin after birth upon admission for delivery. Half of the study participants will only     complete the brief survey. The other half of study participants will then watch a short video     about skin to skin and complete one follow up question regarding their intention to practice     skin to skin at the time of delivery. All patients will be followed until after delivery to     determine if they were able to participate in skin to skin after delivery.   "
6492|NCT03200899|"     The effects of multiple sclerosis (MS) on cognition, thought to occur in 50-75% of persons     with MS, have gained increasing recognition as one of the major disabling symptoms of the     disease. While numerous studies have addressed the emotional and physical impact of MS,     little attention has been given to strategies that might help manage the cognitive changes     commonly experienced by persons with MS. The proposed study will test a novel     computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, &     Problem Solving Skills for Persons with MS). The MAPSS-MS integrates the powerful effects of     group interventions to build self-efficacy for new cognitive compensatory     strategies/behaviors with individual home-based computer-assisted training. The computer     training will assist individuals to develop cognitive skills that they can apply to everyday     life using the compensatory strategies learned in the class sessions. In the recently     completed exploratory study with 61 persons with MS (R21NR011076), the eight-week MAPSS-MS     intervention was acceptable and feasible and had medium to large effects on the use of     compensatory strategies and performance on neuropsychological tests of verbal memory. The     proposed study will test the refined MAPSS-MS intervention with a larger more diverse sample     (N=180) across multiple sites, extend the period of post-intervention follow-up to 6 months     and establish whether performance improvements on neuropsychological tests make the important     transfer to improved neuro-cognitive functioning in everyday life.      The specific aims of this study are to: (1) Evaluate the efficacy of the novel MAPSS-MS     cognitive rehabilitation intervention to improve overall neuro-cognitive competence in     activities of daily living including verbal memory performance, use of compensatory cognitive     strategies and performance on cognitive-related instrumental activities of daily living     (IADL) among persons with MS; (2) Evaluate the efficacy of the MAPSS-MS intervention to     improve self-efficacy and related aspects of cognitive performance (non-verbal     learning/memory, information processing speed and attention, verbal fluency and complex     scanning and tracking) among persons with MS; and (3) Determine the number of intervention     participants who achieve and maintain their self-identified cognitive goals three and six     months following the intervention. The effects of the intervention on outcome variables will     be assessed using a randomized controlled trial design with a comparison group receiving     usual care computer games. Measurements of study variables will occur at baseline,     immediately after the MAPSS-MS intervention, and three months and six months after the     intervention is complete. Statistical analysis will include descriptive statistics and HLM     analysis to account for the nested design. The intent-to-treat approach will be used.      Public Health Statement: This research will provide new knowledge about an innovative     intervention to improve memory, use of compensatory strategies, and performance of cognitive     activities and instrumental activities of daily living for persons with MS. If effective, the     intervention would provide a new and feasible approach to target a serious, debilitating     problem commonly experienced by persons with MS.   "
6554|NCT03200093|"     This study evaluates the role of oral vancomycin in the prevention of recurrent Clostridium     difficile for hospitalized patients receiving systemic antibiotic therapy. Half of     participants will receive oral vancomycin daily, while the other half will receive a placebo.   "
6605|NCT03199430|"     The aim of this study was to explore the impact of acute ingestion of the polyphenol     epigallocatechin galate (EGCG) on catecholamine, catecholamine metabolite, systemic metabolic     and cardio-vascular variables across a range of exercise intensities during graded cycle     exercise in man.   "
6493|NCT03200886|"     Osteoarthritis of the trapeziometacarpal joint (TMJ), also called rhizarthrosis is a common     disease, mostly affecting post-menopausal women. Intra-articular therapy with hyaluronic acid     (HA) was usually recommended as a second-line treatment after failure of non-pharmacological     modalities, only in early stages of the disease .Aim of the present observational,     retrospective, comparative study is the assessment of the efficacy and tolerability of i.a.     injections of an hybrid HA formulation (Synovial H-L®) in comparison to triamcinolone in     patients with TMJ Osteoarthritis (OA). We are analyzing the records collected in the     departmental archives of outpatients affected by TMJ OA, according to the ACR criteria for     the classification for hand OA and who were treated with i.a. Sinovial H-L or triamcinolone     acetonide from December 1st, 2015 to December 1st 2016.The patient's assessment of     spontaneous hand pain on a 0-100 mm VAS with 0 representing the absence of pain and the FIHOA     score validated in Italian language were routinely recorded and documented in our centre     prior to the injections (T0), at the time of the second i.a. administration (T1), after one     month (T2) and after 3 (T3) and 6 months (T4) following the i.a. therapy.      The primary outcome criteria of our study is the change of VAS and FIHOA from baseline to the     end of treatment. Furthermore, we chose as secondary outcomes the duration of morning     stiffness, the Italian version of Health Assessment Questionnaire (HAQ) and the validated     Italian version of the Medical Outcomes Study 36-Item Short Form (SF-36) routinary registered     in our medical record before the i.a. therapy, at the end of the treatment and after 1, 3 and     6 months.      The chi square test, t test or Kruskal-Wallis test, as appropriated, will be used to evaluate     differences between groups before i.a. treatment the clinical and demographical data.      Mixed-effects linear regression models will be used to evaluate temporal trends and     differences in the two groups for specific outcomes: VAS pain, VAS stiffness, FIHOA and PCS     and MCS from SF-36 questionnaires. In these types of statistical models, the effects of the     covariates and their standard errors are correctly estimated taking into account the     hierarchical structure of the data (i.e., patients and visits). For the compute of SF-36s Z     score will be used mean and SD of U.S. general population. Data analysis will be performed     using Stata vers 13.0 software. Descriptive statistics will be used to summarize data as     frequencies (categorical variables) or mean +/-SD (continuous variables) as appropriate. P     values <0.05 is considered statistically significant.   "
6494|NCT03200873|"     Impulsivity describes the tendency to make risky and unplanned decisions, to pick immediate     reward over a bigger reward after a period of time or to not be able to resist the urge to do     something. Empathy refers to the ability to be sensitive to and vicariously experience other     people's feelings and to create working models of emotional states. Recent neuroscientific     research have found that the right frontal part of the brain (left dorsal lateral frontal     cortex, LDLPFC) is important in the control of impulsive behaviour and empathy. Self-report     questionnaires have been proven valid measures at assessing impulsivity and empathy.     Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive brain     stimulation procedure; stimulation can be applied at different brain regions depending on the     administration method. It temporally changes the way that this part of the brain functions,     providing us a further understanding of how this part works. Recent research has found that     rTMS on the LDLPFC changes performance-based tasks measuring different types of impulsivity     and empathy. This study aims to investigate this further to look at the RDLPFC stimulation     and its effects on empathy and two different types of impulsivity. Of interest is also how     innate impulsive personality type and empathy trait relate to performance on these tasks.   "
6495|NCT03200860|"     Acute decompensated heart failure is the fastest growing disease in the world and the leading     cause of hospital admissions worldwide. Short term mortality and rehospitalization are     extremely high (20-30% within 3-6 months) and there is no therapy available that improves     clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose     co-transporter with diuretic and renal- protective properties. In patients with type 2     diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of     hospitalization for heart failure by 35%. Based on the promising pharmacological profile of     empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we     hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure,     with or without diabetes,      This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in     subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be     randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.   "
6497|NCT03200834|"     Comparing different method of surgical technique D2 lymph node dissection vs D3 for right     colon cancer.   "
6498|NCT03200821|"     In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate     non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.   "
6509|NCT03200678|"     An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is     critical to the improvement of knee rehabilitation and preservation. However, if a large     number of studies had rated surgical technics, giving high results level for ACL     reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore     there is no consensus about criteria in return to sport.      The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation     of muscle thigh after ACL surgery.   "
6499|NCT03200808|"     The aim of this study is to demonstrate the safety and effectiveness of mixed methylene blue     compound Injection for the treatment of nonneoplastic epithelial disorders（NNEDS） of vulva.      NNEDS of skin and mucosa of vulva refer to a group of chronic diseases including squamous     hyperplasia and lichen sclerosus, which mainly cause vulvar itching and hypopigmentation.     Usually the itching is severe may influence social activities and sleep. In addition, NNEDS     cause scarring of the vulva which may cause significant sexual dysfunction or pain. The     reasons for NNEDs are not clear and the methods of treatment are diverse. The current     treatments are primarily local drug (e.g. steroid, calcineurin inhibitors, immunosuppressive     agents ), surgical treatments, laser or photodynamic therapy, and the gold standard     treatment for lichen sclerosus is potent steroids creams. However, all the treatments are not     good enough, and the diseases often recur and severely affect women's quality of life. So the     investigators reviewed plenty of literatures, and found some authors used single intradermal     1% methylene blue injection for intractable idiopathic pruritus ani and the effect was good.     As a preliminary experiment, the investigators used intradermal mixed methylene blue compound     injection for a NNEDs patient in the year of 2012, the itching of the patient stopped     immediately and the color of the vulva recovered 6 months later. The patient keeps healthy     till now. And from then on, the investigators designed this study and to verify the effect     and complications of intradermal mixed methylene blue compound injection for the treatment of     NNEDS. So far, there is no similar study reported internationally.   "
6606|NCT03199417|"     Randomized controlled trial regarding the efficacy of a multimodal topical analgesic,     Multiprofen, in comparison to placebo cream treatment on knee pain and function in patients     with knee osteoarthritis.   "
6500|NCT03200795|"     Background. Diabetes is a global epidemic disease. The prevalence of diabetes for all age     groups worldwide was estimated to be 2.8% in 2000 and is predicted to affect 4.4% by 2030.     The global prevalence of diabetics is currently estimated to be 285 million and projection     rates are expected to rise to over 438 million by the year 2030, with Asians suffering the     bulk of the total diabetes epidemic.      The incidence of chronic diseases of lifestyle such as Type 2 Diabetes Mellitus (DM) is on     the increase amongst the South African population. Due to the numerous factors such as lack     of education, inaccessibility of healthcare facilities and/or poor socio-economic background,     diabetes mellitus often goes undetected in rural areas, resulting in an increase in     musculoskeletal complication and other diabetes mellitus complications. Inability to control     blood sugar may induce serious complications such as renal disease, peripheral neuropathy,     retinopathy, and vascular events. Due to its multi-systemic nature, diabetes will lead to the     development of additional manifestations such as musculoskeletal complications, reduces     respiratory capacity, depression and poor quality of life.      Studies have shown that both exercises and pharmacotherapy can decreases depression and     improved glycemic control and overall quality of life of persons with diabetes. Thus, in     addition improve the quality of life and substantial financial savings and improved medical     care of these individuals.      Hypothesis        1. There will be no statistical significant difference in glycemic control, cholesterol          level, respiratory parameters, pain scores, depression and quality of life among type 2          diabetes patients at the baseline and at the end of 8 weeks of rebound exercises.        2. There will be no statistical significant difference in glycemic control, cholesterol          level, respiratory parameters, pain scores, depression and quality of life among type 2          diabetes patients at the baseline and at the end of 8 weeks of circuit resistance          training.        3. There will be no statistical significant difference in glycemic control, cholesterol          level, respiratory parameters, pain scores, depression and quality of life among type 2          diabetes patients at the baseline and at the end of 8 weeks of routine care.        4. There will be no statistical significant difference in glycemic control, cholesterol          level, respiratory parameters, pain scores, depression and quality of life among type 2          diabetes patients between the rebound exercises group, circuit training and routine care          at the baseline.        5. There will be no statistical significant difference in glycemic control, cholesterol          level, respiratory parameters, pain scores, depression and quality of life among type 2          diabetes patients between the rebound exercises group, circuit training and routine care          at the end of 8 week of the programme.      Summary of the proposed research methodology. The participants will be randomised into three     groups. The first group will be engaged in rebound exercise, the second group will be engaged     in circuit training while the third group will continue with their normal care of medication.     But before the commencement of the study, pilot study will be conducted on normal subjects.     Measurement will be carried out at the baseline, four weeks and at the end of the programme,     'The following parameters will be measured. Pain level, blood glycemic level of each     participant, cholesterol level, depression and quality of life.   "
6501|NCT03200782|"     The purpose of the study is to investigate whether hypoglycaemia observed after food intake     in bariatric patients can be either influenced by an SGLT2 inhibitor, empagliflozin, or via     inhibition of inflammation with an human interleukin-1 receptor antagonist (IL1-RA,     anakinra).   "
6502|NCT03200769|"     Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant     Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep     apnea syndrome treatment by CPAP on the epilepsy seizures frequency.   "
6503|NCT03200756|"     This trial randomizes patients who plan to attend cardiac rehabilitation to either a     behavioral intervention to specifically reduce sedentary behavior or to usual care which     exclusively focuses on increasing exercise.   "
6504|NCT03200743|"     Catestatin is a kind of protein involved with cardiovascular disease. Accumulated evidence     shows that Catestatin may be a predictor of primary hypertension, but whether it plays the     same role in pregnant hypertensive disorders needs to be determined. By measuring the plasma     level of Catestatin, main biochemical marks and UCG in healthy pregnancy and pregnancy with     hypertension, the research may contribute to this problem.   "
6505|NCT03200730|"     Background: The lack of a holistic approach to palliative care can lead to a fractured sense     of dignity at the end of life, resulting in depression, hopelessness, feelings of being a     burden to others, and the loss of will to live among terminally-ill patients. Building on the     clinical foundation of Dignity Therapy, together with the empirical understanding of     dignity-related concerns of Asian families facing terminal-illness, a novel Family Dignity     Intervention (FDI) has been developed for Asia palliative care. FDI comprises a recorded     interview with a patient and his/her primary family caregiver, which is transcribed, edited     into a legacy document, and return to the dyads for sharing with the rest of the patient's     family. The aims of this study are to assess the feasibility, acceptability and potential     effectiveness of FDI in reducing psychosocial, emotional, spiritual, and psychophysiological     distress in community-dwelling and in-patient Asian older terminally-ill patients and their     families living in Singapore.      Methods/Design: An open-label multicentre randomized controlled trial. 126 patient-family     dyads are randomly allocated to one of two groups: (i) intervention group (FDI offered in     addition to standard psychological care), and (ii) control group (standard psychological     care). Both quantitative and qualitative outcomes are assessed in face-to-face interviews at     baseline, three days and two week after intervention, and during an exit interview with     family caregivers at two month post bereavement. Primary outcome measures include sense of     dignity for patients and psychological distress for caregivers. Secondary outcomes include     meaning in life, quality of life, spirituality, hopefulness, perceived support and     psychophysiological well-being, as well as bereavement outcomes for caregivers. Qualitative     data are analyzed using Framework method.      Discussion: To date, there is no available palliative care intervention for dignity     enhancement in Asia. This first-of-its kind study develops and tests an evidence-based,     family-driven psycho-socio-spiritual intervention for enhancing dignity and wellbeing among     Asian patients and families facing mortality. It address a critical gap in the provision of     holistic palliative care. The expected outcomes will contribute to advancements in both     theories and practices of palliative care for Singapore and other Asian communities around     the world.   "
6506|NCT03200717|"     An international, multicenter, single arm Phase II trial to determine the efficacy, safety     and quality of life of pazopanib treatment after previous therapy with immune checkpoint     treatment. Approximately 140 patients will be enrolled. Patients will receive treatment with     standard dose pazopanib until disease progression, unacceptable toxicity, pregnancy, death,     discontinuation from the study treatment for any other reason or until study end. All     patients will be followed for survival. Patients who discontinue treatment without documented     disease progression will be followed for efficacy.   "
6507|NCT03200704|"     This is a randomized, prospective, open label, multicenter study to assess the effectiveness     of IC2000 and SPY Fluorescence Imaging Systems (SPY) in the identification of lymph nodes     during lymphatic mapping in subjects with breast cancer.   "
6508|NCT03200691|"     The objective of this study is to evaluate the efficacy and safety of radiation therapy     combined with anti-PD-1 antibody SHR-1210 followed by surgery in treating patients with     resectable esophageal squamous cell carcinoma   "
6510|NCT03200665|"     Sonographic fetal weight estimation at the last weeks of third trimester in low-risk     pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting     close surveillance and timely delivery. The need for a systematic ultrasound evaluation at     the last weeks of a low-risk pregnancy and the best time to perform it remains controversial.     The most commonly used clinical screening tool in this population is the serial measurement     of symphysis-fundus distance, which is a method of a variable and low sensitivity for     detection of FGR.      In Portugal, in accordance with guidelines of Direcção Geral de Saúde from 2015, fetal growth     restriction screening in low risk pregnancies is performed with an ultrasound for fetal     weight estimation at 30th-33rd weeks. Nonetheless, recent data from randomized trials showed     that FGR detection rate was superior at 36 vs 32 weeks' gestation. In cases of severe FGR,     detection rate was also superior at 36 vs 32 weeks' gestation. In a prior retrospective     study, our group analyzed 1429 term low risk pregnancies and the investigators concluded that     small for gestational age term babies (birthweight < 10th centile) had a statistically     significant higher rate of operative deliveries for intrapartum fetal distress than     appropriate for gestational age as well as a higher rate of admission to neonatal intensive     care unit. Moreover the investigators compared the same outcomes within small for gestational     age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected (normal     30th-33rd weeks ultrasound). Antepartum detection of small for gestational age neonates     showed a statistically significant lower rate of operative deliveries for intrapartum fetal     distress than undetected small for gestational age neonates. The investigators will conduct a     prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the     standard of care ultrasound in low risk pregnancies is effective in improving the detection     rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission     to neonatal intensive care unit.   "
6607|NCT03199404|"     This purpose of this retrospective, single-arm, non-randomized, multi-center study is to     collect real-world data on the effectiveness of using the TRAP technique in acute ischemic     stroke patients undergoing mechanical thrombectomy.   "
28677|NCT02910284|"     This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and     immunogenicity of GEN-003 in subjects with genital HSV-2 infection.   "
6511|NCT03200652|"     Protein is the key determinant of growth and bodily functions. The quality of food proteins     depend on their amino acid content and the amount of amino acids used by the body to make     proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and     exceed 80% in poorer developing countries. In many of those countries, wheat is the major     cereal grain in the diet. The protein in wheat is low in the essential amino acid lysine.     Hence wheat protein is of low quality. Low lysine affects protein synthesis in the body.     Cooking methods also affect the lysine available from foods to the body.The protein can be     complemented by the addition of lentils to augment the low lysine content. However, lentils     are prohibitively expensive in some developing countries.      As the human population increases, the world faces the continuous challenge of maximizing a     limited food supply. Protein quality (PQ) evaluation of wheat directly in humans would allow     us to bridge the gap in knowledge between what is required and how best to provide.The     information gathered from this project will provide the first direct experimental data on PQ     of wheat protein in humans on which nutrition recommendations can be built.   "
6512|NCT03200639|"     The study aim was to compare the effectiveness of combined training (CT; aerobic + resistance     exercises) and high-intensity interval body weight training (HIITBW) on body composition,     metabolic and inflammatory profile, physical function and quality of life in older women with     gynecological and breast cancer and their pair-matched controls (older women with no cancer).     The hypothesis of the present clinical trial is that HIITBW is effective as well as CT for     improvements on body composition, metabolic and inflammatory profile, physical function and     quality of life in older women with gynecological and breast cancer.   "
6513|NCT03200626|"     Prospective, multicenter, observational registry of myeloma patients undergoing hematopoietic     progenitor cell mobilization for upfront autologous transplantation.   "
6514|NCT03200613|"     Thromboprophylaxis options are limited for patients with acute spinal cord injury (SCI) and     there are no studies on direct oral anticoagulants (DOACs) for thromboprophylaxis in this     population. Participants will be randomized to apixaban 2.5 mg twice daily or standard dose     low-molecular-weight heparin (LMWH), either enoxaparin 40 mg or dalteparin 5000 units,     subcutaneously once daily for 90 days or until fully mobilized, whatever comes first.     Thromboprophylaxis will be started as soon as hemostasis is achieved. The primary outcome for     this pilot study will be the recruitment rate per year (i.e. the screened to enrolled ratio).     The primary efficacy endpoint will be a composite of symptomatic, objectively verified,     venous thromboembolism (VTE), defined as upper or lower limb deep vein thrombosis (DVT)     and/or pulmonary embolism (PE) or sudden death where PE cannot be excluded. The primary     safety endpoint will be major bleeding.   "
6515|NCT03200600|"     Delirium is a common complication in elderly patients after surgery. And its occurrence is     associated with worse outcomes. The causes of delirium are multifactorial but may include     pain, stress response and inflammation. Dexamethasone is commonly used to prevent the     occurrence of postoperative nausea and vomiting. In a randomized controlled trial, small-dose     dexamethasone (8 mg) administered before anesthesia induction improved the quality of     recovery in patients after cardiac surgery. Flurbiprofen axetil is commonly used to improve     postoperative analgesia while decreasing the requirement of opioids. In a randomized trial of     the investigators, combined use of flurbiprofen axetil with sufentanil for postoperative     analgesia reduced delirium in elderly patients after orthopedic surgery. The purpose of this     2 plus 2 factorial randomized controlled trial is to test the hypothesis that combined use of     dexamethasone and flurbiprofen axetil may reduce delirium in elderly patients after lung     cancer surgery.   "
6516|NCT03200587|"     This is an open-label, non-controlled, non-randomized, phase I dose-finding, of Cabometyx +     Avelumab, to establish safety, feasibility, and the maximum tolerated dose (MTD) or     Recommended Phase 2 Dose (RP2D) of Cabometyx in combination with Avelumab, and to investigate     preliminary efficacy. The MTD or RP2D determined in this study will be used for a future     study to formally test efficacy.   "
6517|NCT03200574|"     This is a prospective, interventional, multi-center trial to report the overall incidence of     reduced leaflet motion identified by CT imaging in patients receiving a commercially approved     LivaNova bioprosthetic aortic heart valve up to 1 year post implant.   "
6545|NCT03200210|"     The investigators will enroll continuous ambulatory peritoneal dialysis (CAPD) patients with     hyperuricemia and randomly divide them into two groups, treated with Febuxostat and placebo     respectively. After 3 years of following up, cardiovascular events, all cause mortality,     cardiovascular mortality and non-fatal cardiovascular events are collected and recorded. The     difference of cardiovascular events, all cause mortality and non-fatal cardiovascular event     rate will be analyzed.   "
6546|NCT03200197|"     The objective of this study was to compare the effectiveness of menthol chewing gum compared     to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst     during the preoperative period. The hypothesis of the study was that the use of menthol     chewing gum in surgical patients in the preoperative period would be more effective than the     maintenance of fasting with regard to the decrease in thirst and its discomforts.   "
6547|NCT03200184|"     The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for     the treatment of hepatitis C in Iran. In this study the efficacy of this combination is     evaluated in 1000 patient with hepatitis C.   "
6555|NCT03200080|"     This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double     dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to     d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational     polydrug users with stimulant experience, under fed conditions.      Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification     (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.   "
6556|NCT03200067|"     In order to study the effectiveness of personalized healthcare service program for breast     cancer rehabilitation, investigators designed this study using mobile phone and clinical     intervention(feedback coaching).   "
6608|NCT03199391|"     The purpose of this study is to collect postmarket data in subjects who receive surgical     treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™     SureLock™ implant. Both performance and safety data will be collected.   "
6518|NCT03200561|"     Background:      Kawasaki disease (KD), most popular acquired heart disease in childhood, is characterized by     diffuse vasculitis, especially on the middle-sized muscular arteries. IVIG and aspirin are     currently standard treatment. However, 10-15% of KD patients have poor response to such     treatment and suffer from higher risk of coronary involvement. Recently, combination of     prednisolone and IVIG has been shown effective to lower the chance of refractory to IVIG     treatment and subsequent coronary lesions. However, no randomized trial on the steroid     efficacy was ever conducted in Taiwan.      Aim:      Prospectively randomized open-label trial to evaluate the add-on effect of prednisolone in     the refractory KD children.      Methods:      For the KD patients with fever persisted or relapsed 24 hours after the ending of IVIG     infusion, they will be randomized into two group: IVIG group (I) and IVIG + prednisolone     group (P). The KD patients in the P group will have in addition to IVIG, oral prednisolone     2mg/kg/day for at least 5 days. The difference in the response rate and percentage of     coronary involvement will be compared between I and P groups.      Predicted results:      We plan to enroll 100 refractory KD patients, 50 patients for each group. We predict the risk     of coronary involvement can be reduced from 30% to 15%.   "
6519|NCT03200548|"     Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by     involvement of multiple organs with a female to male ratio of 12:1 with the highest incidence     reported in women of child bearing age (15-44 years). In general, advances in diagnosis and     management have led to significant improvements in outcomes. However, fatigue remains a     challenging and prevalent issue for SLE patients.      The investigators aim to determine the feasibility of recruiting and conducting acupressure     in fatigued persons with lupus; to explore the effect of two distinct acupressure formulas     (relaxing and stimulating) plus usual care versus sham acupressure plus usual care and usual     care alone on severity and impact of chronic fatigue (as measured by the Brief Fatigue     Inventory) as well as quality of life, sleep and pain.   "
6520|NCT03200535|"     Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin     A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that     programs such weight management classes and one-on-one counseling with registered dieticians     can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser     Permanente Colorado members in these activities is low. The purpose of this study is to     determine which of three outreach methods is most effective in increasing engagement in these     activities.   "
6521|NCT03200522|"     This research is being done to evaluate the feasibility of a prudent versus Western diet     feeding study in women with asthma in Baltimore City. The results of this research will     provide data to appropriately design a definitive study looking at the differential effects     of these two diets on asthma health.   "
6522|NCT03200509|"     Physical activity plays an important role in the management of chronic low back pain (LBP).     Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is     evidence to suggest that patients with chronic LBP are less likely to meet recommended     physical activity levels. Furthermore, while exercise therapy has been endorsed by recent     clinical practice guidelines, evidence from systematic reviews suggests that its effect on     pain and disability are at best moderate and not sustained over time. A limitation of current     exercises programs for chronic LBP is that these programs are not designed to change     patient's behaviour toward an active lifestyle. Therefore, the objective of this study is to     investigate the short and long-term efficacy of a multimodal intervention consisting of     supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex)     compared to supervised exercises plus sham coaching and a sham activity monitor on physical     activity levels, pain intensity and disability in patients with chronic nonspecific LBP.   "
6523|NCT03200496|"     This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and     safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and     Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy     male subjects   "
6524|NCT03200483|"     Check the effects of musical auditory stimulation on the autonomic modulation and     cardiorespiratory parameters during and after aerobic exercise. Hypothesized that classical     music can increase recovery velocity after exercise and rock style music can generate a delay     in the recovery velocity of the cardiorespiratory parameters and in the cardiac autonomic     response.   "
6525|NCT03200470|"     This is a prospective multicenter study. All patients presenting for revision hip or knee     arthroplasty for all indications under the respective surgeon's care may be eligible. Per     standard of care preoperatively, all patients must have blood drawn for erythrocyte     sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in     question may be performed at the discretion of the treating surgeon and results documented.     Intraoperative samples will also be collected and sent for NGS analysis   "
6526|NCT03200457|"     The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on     the same day on a series of 80 patients.   "
6527|NCT03200444|"     This study investigates the impact and adhesion of new adhesives to the skin.   "
6528|NCT03200431|"     The purpose is to investigate the impact real output has on the peristomal skin covered by a     newly developed adhesive.   "
6529|NCT03200418|"     The study investigates the impact real output has on the adhesion of the adhesives.   "
6530|NCT03200405|"     The purpose of this study is to determine the exact position of a mesh which is placed in     underlay position in umbilical hernia in vitro. The investigators want to gain information if     the mesh lays directly next to the abdominal wall fascia or if there´s fat tissue between     mesh and fascia. Furthermore they hope to get some information about the tissue     incorporation.   "
6531|NCT03200392|"     A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and     Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective     tissue graft harvesting compared to conventional scalpel surgical technique in the treatment     of class I and II Miller gingival recession.   "
6532|NCT03200379|"     To determine the treatment efficacy, safety and long-term outcomes of chronic hepatitis C     patients receiving directly acting antivirals in Taiwan   "
6548|NCT03200171|"     Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of     hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C     (CHC).   "
6533|NCT03200366|"     The purpose of this study is to test different approaches to help people understand the     purpose of colorectal cancer (CRC) screening, two screening test options available, and the     barriers to screening so they can make informed decisions about CRC screening. Participants     will be randomly assigned to one of three groups: (1) one group will receive a tailored     digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus     telephone calls from a patient navigator; and (3) the third group will receive the care     normally provided by the healthcare system's endoscopy department.      The investigators hypothesize the following: (1) participants who receive the tailored DVD     plus the patient navigation intervention will have higher rates of CRC screening with the     fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who     receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or     DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy,     or either screening test than those who receive usual care; and (3) participants who receive     either intervention who complete colonoscopy will have better quality of bowel preparation,     less anxiety about the procedure, and greater satisfaction with the colonoscopy experience     than those who receive usual care.   "
6534|NCT03200353|"     Patient with chronic wounds are selected to receive NATROX system ; it's a continous     diffusion of oxygen therapy delivery system. This one is put on the wound during a     consultation at the hospital and will be followed in home medical care. Every 2 days a nurse     renew the application at home and patient recharge the system with oxygen every day.      The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to     have a consultation with the doctor.   "
6535|NCT03200340|"     This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects     with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to     receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy     (cisplatin). Informed consent will be obtained from each subject prior to enrollment.      The trial will be performed in 2 stages:      Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24     subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three     doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo. Stage 2 of the     study will evaluate both safety and efficacy.      Sixty (60) subjects will be randomized in a 1:1 scheme to receive either placebo or EC-18 at     the dose determined in Stage 1.   "
6536|NCT03200327|"     The investigators anticipate a reduced risk of post-operational de novo stress urinary     incontinence following surgery for prosthetic vaginal sacrospinofixation, associated with     reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and     rate of dyspareunia with the new treatment   "
6537|NCT03200314|"     A prospective, observational study will be performed measuring recirculation of blood through     a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory     distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to     recirculation.   "
6538|NCT03200301|"     The investigators hypothesise that intact umbilical cord milking (I-UCM) will reduce neonatal     morbidity and improve long term neurodevelopmental outcome in very preterm infants. All     babies born less than 32 weeks gestation, meeting the inclusion criteria will be randomly     assigned to either I-UCM or immediate cord clamping (ICC) and their short and long term     outcome measures analyzed.   "
6539|NCT03200288|"     This is a study to evaluate the Clinical Performance and Safety of a single intra-articular     (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to     osteoarthritis (OA) of the knee.   "
6540|NCT03200275|"     There has never been a paper published or research done to determine the rate of Legionella     species as a cause of community or nosocomial acquired pneumonia requiring hospitalization in     Malaysia. Anecdotally, Legionnaires' disease is thought to be uncommon in Malaysia. This is     one of the first prospective hospital-based studies to comprehensively evaluate the     epidemiological and demographical factors of patients hospitalized with Legionella infection     in Malaysia.   "
6541|NCT03200262|"     The shoulder is the most mobile joint in the body, and the most exposed to the risk of     dislocation notably anterior. Chronic instability of the shoulder is frequent after     dislocation, and principally affects people who are young and active. It can have major     functional repercussions, leading to restricted participation in professional or sports     activities, even in everyday life activities.      Surgical stabilisation is the reference treatment for chronic anterior shoulder instability,     and has given good results. There are numerous surgical techniques available; the     orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy,     following many years of reflexion and adaptation.      Rehabilitation following the surgery is essential, notably to recover muscle strength in the     shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the     joint. At the moment, we do not know the objective evolution of muscle strength after the     Trillat arthroscopic technique.      The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is     reproducible. It gives objective and reliable values for muscle strength, thus making it     possible to guide and to optimise rehabilitation protocols done by patients under the     supervision of a physiotherapist, and to estimate time to the return to physical,     professional or sports activities, without risk.   "
6542|NCT03200249|"     Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by     RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse,     often associated with poor prognosis      Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with     concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or     cN1-2.   "
6543|NCT03200236|"     The purpose of this study is to compare intensive telephone counseling (ITC) plus the     nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC)     among current smokers undergoing lung cancer screening. Smoking-related outcomes will be     examined at three, six and twelve months post-randomization.   "
6544|NCT03200223|"     In order to study the effectiveness of personalized healthcare intervention for     lifestyle-related diseases, investigators designed this study using mobile application and     clinical feedback coaching.   "
6549|NCT03200158|"     To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).   "
6557|NCT03200054|"     South Africa is implementing the policy of universal initiation of lifelong antiretroviral     therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease     stage (Option B+). There is a recognised need for innovative models of service delivery to     support adherence and retention in care in this group, particularly during the postpartum     period. The investigators are conducting a pragmatic randomised control trial to compare     virological outcomes 24 months postpartum in two models of service delivery for provision of     HIV care and treatment services postpartum in women who initiated ART during pregnancy: local     adult ART clinics and community-based adherence clubs.   "
6558|NCT03200041|"     The purpose of this study is to evaluate the performance of the IONA® test which is a     non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in     twin pregnancies, from a maternal blood sample.   "
6559|NCT03200028|"     The primary objective of this study is to evaluate the effects of the revised brain training     program on the cognitive abilities (e.g., attention, executive function), functional status     and quality of life of individuals diagnosed with Alcohol Use Disorder (AUD) and     Post-Traumatic Stress Disorder (PTSD).   "
6560|NCT03200015|"     Evaluation of the safety and effectiveness of metformin as an adjunct to RCHOP chemotherapy     for patients with newly diagnosed diffuse large-B cell lymphoma   "
6561|NCT03200002|"     This was a prospective open label randomized control trial, which was conducted for a period     of one and half year from January 2014 to June 2015. Out of 52 patients screened, 49 patients     meeting the international society of nephrology/ renal pathology society (ISN/RPS) criteria     were enrolled in the study comprising of 25 and 24 patients in the cyclophosphamide (CYC) and     mycophenolate mofetil (MMF) groups respectively. Forty two patients (21 in each group) could     complete the study till the end of 6 months and were included in final analysis. Baseline     clinical evaluation and investigations were done and recorded. CYC was given intravenously as     a monthly pulse in the dose of 0.5 to 1 gram per m2 body surface area. MMF was administered     in the tablet form with the starting dose of 500 mg twice daily, which was increased to 750     mg twice daily after a month. Patients were assessed and monitored monthly and the details     were recorded. Efficacy of treatment was measured as primary end point for those who achieved     partial remission (reduction of 24 hour urinary protein to < 3.5gms/day if baseline     proteinuria >3.5 gms/day or decrease by 50% if baseline proteinuria <3.5 gms/day) and     secondary end point for those who achieved complete remission (normalization of serum     creatinine and < 500 mg of 24 hour urinary protein). Adverse events experienced by the     patients were also recorded during monthly visit.   "
6562|NCT03199989|"     The purpose of this study is to design a prospective randomized clinical trial to explore     whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon     cancer patients with high risk factors.Therefore the investigators can provide high level     clinical evidence of indications for patients with colon cancer with stage II colon cancer.   "
6563|NCT03199976|"     This study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed     versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as     needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or     shortness of breath.   "
6564|NCT03199963|"     A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to     placebo for reducing breast tissue density in women identified as having dense breast tissue     upon analysis of screening mammography. The Primary Study Endpoint being the percent     reduction of mammographic breast tissue density on a follow-up mammogram compared to the     baseline mammogram after 52 weeks of treatment.   "
6565|NCT03199950|"     The hospital pharmacy at the Zuyderland Medical Centre developed the DElirium MOdel (DEMO) to     predict which patients are at risk of developing a delirium in patients aged 60 or older.     With this delirium risk prediction model we aim to predict more accurately which patients are     at high risk of developing a delirium and want to investigate if these patients can benefit     from prophylactic haloperidol.   "
6566|NCT03199937|"     The purpose of this project is to test the effectiveness of a novel school-based intervention     targeting executive function skills, including flexibility and planning, in college-track,     transition-age youth with ASD. Evaluating treatment change through behavior and brain     activity provides important information on how the treatment works and who will best benefit     from it.   "
6567|NCT03199924|"     to evaluate the analgesic effect of a standard dose of intravenous magnesium added to     intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular     diclofenac or intramuscular diclofenac alone in patients presenting to the emergency     department with renal colic and whether it can reduce opioid consumption.   "
6569|NCT03199898|"     Depending on their gestational age, preterm infants need several weeks with different types     of breathing-support due to immature development of the lungs, respiratory muscles,     chest-wall and respiratory center in the brain. WHO`s recommendation on interventions to     improve preterm birth outcomes underline the need for more research on respiratory support in     infants born preterm. This study will test inter-rater and intra-rater reliability of the     Silverman-Andersen Retraction Score, which is a systematic clinical scoring tool for the     respiratory work and the severity of respiratory distress in preterm infants. It will examine     if there is consistency in the assessments done by doctors and nurses, and also if the     observations correlate with technological monitoring. This easy to use scoring tool will help     to determine the grade of respiratory distress, to assess respiratory exacerbation, to decide     when to start weaning from respiratory support, and to give the best respiratory treatment to     the child. This study will contribute to optimize care for preterm infants with respiratory     distress.   "
6570|NCT03199885|"     This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with     or without pembrolizumab works in treating patients with breast cancer that has spread to     other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab,     pertuzumab, and pembrolizumab, may interfere with the ability of tumor cells to grow and     spread. Giving paclitaxel, trastuzumab, and pertuzumab with pembrolizumab may kill more tumor     cells.   "
6571|NCT03199872|"     The study will evaluate safety and immunological response to RhoC peptide vaccine in patients     with prostate cancer   "
6574|NCT03199833|"     Stroke is the third most common cause of death and the main cause of acquired adult     disability in high-income countries. The most common deficit after stroke is motor impairment     of the contralateral arm, with more than 80% of stroke survivors experiencing this condition     in the acute phase, and only half regaining some useful upper limb function after six months.      Within the European project RETRAINER (grant agreement No 644721), the consortium developed a     platform for the rehabilitation of the upper limb after stroke, which combines a passive     forearm-hand orthosis for hand-wrist motion stabilization, selective fingers constraining and     grasp movement facilitation, Functional Electrical Stimulation (FES) of the extrinsic hand     flexor muscles and of the extrinsic hand extensor muscles, interactive objects, and voluntary     effort. The system also provides a graphical user interface which helps the therapist set the     training session and save the training data and parameters, and provides the subject a visual     feedback about his/her active involvement in the exercise. The training consists of the     execution of a series of exercises involving the affected arm during daily life activities.     Typical exercises include controlled wrist flexion and extension, controlled fingers flexion     and extension, anterior reaching and grasping on a plane or in the space, moving an object on     a plane or in the space.      The aim of this clinical study it to evaluate the efficacy of this novel training platform on     patients between two weeks and nine months after their first stroke, who preserved at least a     visible muscle contraction for the arm and shoulder muscles. Participants are randomized in     an experimental and a control group. The control group is trained with an advanced     rehabilitative program, including physical training, occupational therapy, FES, and virtual     reality, while the experimental group is trained with the RETRAINER system for about 30     minutes, in addition to the same program of the control group. The daily training time is the     same for the two groups. The intervention consists of three sessions a week for nine weeks.     Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week     follow-up visits. It is planned to recruit 68 subjects for this study. Since the RETRAINER     platform was built on the up-to-date theory of motor re-learning, which supports     task-oriented repetitive training, a close temporal association between motor intention and     stimulated motor response, and an intensive and frequent training paradigm, the study's     hypothesis is that the experimental group shows a greater treatment effect than the control     group.   "
6575|NCT03199820|"     This study will randomise low-risk women to compare the effectiveness of trans-cervical     balloon catheter for pre-induction cervical ripening for out-patient induction of labour with     current practice (Propess). Women will be randomised to two treatment groups. The     investigators wish to explore if such a trial is feasible, acceptable to women and what data     collection is required for a future trial. Since no data exist, the investigators propose a     study with approximately 60 women in each arm across two recruiting sites.   "
6576|NCT03199807|"     The study herein successfully developed a new immunotherapeutic approach combined with     radiotherapy, and tried to proved it to be more effective and safe.   "
6577|NCT03199794|"     The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of     bleeding episodes in real-life clinical practice in Europe.   "
6578|NCT03199781|"     PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics     in improving body contour and appearance of gynoid lipodystrophy.      SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be     performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted     data collection and assessments and before and after treatment.      HYPOTHESES: It is expected that the patients will present improvement in the body contour and     in the picture of the gynoid lipodystrophy after the association of the therapies.      STATISTICAL ANALYSIS: A descriptive analysis will be done before and after     vibration-oscillatory therapy, with frequency tables for categorical and descriptive     variables (mean, standard deviation, median, minimum and maximum values) for continuous or     numerical variables. In order to compare the main variables between the groups and the     collection times, the analysis of variance (ANOVA) for repeated measurements will be used.     Tukey's test will be used to compare groups. The level of significance adopted for the     statistical tests will be 5% or p <0.05.   "
6579|NCT03199768|"     To investigate whether single-bed rooms can prevent and reduce incidence and duration of     delirium compared to multi-bed rooms in elderly patients admitted to a geriatric department.     In addition, it is investigated whether single-bed rooms reduce the use of psychotropic     drugs, opioids, parenteral medication, fixed guard, falls, hospitalization and discharge to     institution among delirious patients. Furthermore, to study if delirium is associated with of     re-hospitalization, traumatic fall, institutionalization and death within 30 days, compared     to those who do not develop delirium.   "
6580|NCT03199755|"     The overall goal is to validate efficacy and potential superiority of dried leaf Artemisia     annua (DLA) vs. artemisinin combination therapy (ACT) to cure malaria and to demonstrate     elimination of the transmission stage (gametocytes) of the disease. This is a 3 arm trial in     Democratic Republic of Congo covering 600 total adult and pediatric patients. Final     validation of infection from dried blood samples will be done at WPI.   "
6581|NCT03199742|"     The purpose of this study is to evaluate a mobile phone app designed to help Veterans with     PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone     apps. The term randomized means that which app a participant receives will not be based on     any characteristic or behavior of the participant, but will be determined solely by chance     like a flip of a coin.   "
6582|NCT03199729|"     The long-term objective of this research is to develop an efficacious training paradigm to     enhance older adults' defense mechanisms against falls and possibility reduce healthcare     cost. The Centers for Disease Control and Prevention estimates the direct medical cost for     fall related injuries to be $30 billion annually. Slips and trips combined account for more     than 50% of the outdoor falls in community-dwelling older adults. These environmental     perturbations are opposing in nature, with slips mainly resulting in backward falls and trips     in forward falls. This project explores perturbation training through both slip and trip     exposure based on the principles of motor learning. The project design consists of a     randomized controlled trial to examine the ability of the central nervous system to mitigate     the interference in stability control (if any) that is induced by opposing types of     perturbations. It also introduces a novel combined slip and trip perturbation training     paradigm to enhance one's ability to retain and generalize the acquired fall-prevention     skills to both types of falls. Slips and trips induced on an over ground walkway will be used     to prepare the motor system to improve stability control and vertical limb support to resist     falls. The longer-term benefits of such combined perturbation training over exclusive     slip-only or trip-only perturbation training in reducing both laboratory-induced and real     life falls will also be assessed. The hypothesis of this study if supported by the results     will provide an evidence-supported training protocol to reduce the fall-risk among     community-dwelling older adults.   "
6631|NCT03199092|"     The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training     (RRT), a computer-assisted intervention method that combines sublexical reading exercises     with rhythm processing, and that of a multimodal intervention comprising different     methodology, called 'Abilmente'. All interventions were delivered for a period ranging 1-2,5     months, in 60 minutes biweekly sessions.   "
6583|NCT03199716|"     The study aim is to determine if parent mentors can improve adherence to the intensive     multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the     frequency of blood glucose measurements. Researchers are also trying to determine if the     parent mentors can improve glycemic control, which is measured through HbA1c. The study     hypothesis is that trained parent mentors can help families with children who have poorly     controlled T1DM improve adherence to their diabetes regimen and improve their metabolic     control.   "
6584|NCT03199703|"     This will be a prospective single-blinded, randomized, controlled trial comparing the     effectiveness and safety of transseptal puncture using the Baylis transseptal system to     transseptal left atrial access with standard transseptal equipment (usual care) in patients     undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.      The targeted population will consist of patients with symptomatic paroxysmal atrial     fibrillation undergoing pulmonary vein isolation with the cryoballoon system.   "
6585|NCT03199690|"     The purpose of the study is to see how the drug Dolutegravir is broken down by your body,     when taken with another drug called Rifampicin. Dolutegravir is given to people as a     treatment for HIV. Rifampicin is given to people as a treatment for tuberculosis.   "
6586|NCT03199677|"     This is a single-center, open-label, single arm，exploratory clinical trial evaluating the     efficacy and safety of Apatinib in patients with local progressive/metastatic refractory     thyroid cancer.   "
6587|NCT03199664|"     The study will compare the effectiveness of combined treatment with NB-UVB and tacrolimus     versus NB-UVB alone . Patients will be treated for 6 months and followed up after 3 months     .All types of vitiligo will be included except universal vitiligo.   "
6588|NCT03199651|"     This randomized clinical trial studies the Beating Lung Cancer in Ohio protocol in improving     survival in patients with stage IV non-small cell lung cancer. The Beating Lung Cancer in     Ohio protocol may help in evaluating immunotherapies and targeted therapies that prolong     survival, have more favorable toxicity profiles than conventional chemotherapy and impact     quality of life.   "
6589|NCT03199638|"     This project will assess the feasibility and efficacy of the use of exercise and dietary     supplementation with a non essential amino acid - glutamine - a component of most protein     supplements, on the regulation of plasma glucose homeostasis in a clinical setting of     children with type 1 diabetes (T1D). The study specifically targets patients in puberty as     this period is associated with a physiological decline in insulin sensitivity, the latter     often associated with poor control. Although physical exercise has long been known to exert     beneficial effects on metabolism, lack of time is the most common reason perceived as     preventing the performance of exercise in both healthy and diabetic subjects. In earlier     studies, we showed that oral supplementation with glutamine, a non essential amino acid given     prior to exercise decreases overnight post-exercise blood glucose in adolescents with T1D.     Hence, the objective of the current study is to investigate if a novel way of exercising,     such as performing 6 short bouts of just 1 min each of intense exercise ('exercise snacks')     30 min before meals, with or without glutamine, improves glycemic control in adolescents with     T1D. Designing innovative ways to improve diabetes control in adolescents is highly     desirable. The specific aim of the project is to determine whether the sustained use of the     proposed exercise snacks with or without glutamine results in diminished glycemic variability     and/or improved glucose control   "
6602|NCT03199469|"     This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent     control clinical study to evaluate the safety and preliminary efficacy of AT132 in subjects     with X-Linked Myotubular Myopathy aged less than 5 years old. Subjects will receive a single     dose of AT132 and will be followed for safety and efficacy for 5 years   "
6603|NCT03199456|"     The Zip-009 clinical investigation will enroll 26 paediatric subjects requiring laceration     repair and fulfilling the eligibility criteria for the clinical investigation. The     investigation is designed to evaluate the time and cost savings and the satisfaction and     outcomes of the Zip 4 device compared to conventional sutures. The subjects will be randomly     assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the     Standard of Care sutures group. The investigation consists of one screening/baseline visits     at day 0 where the subject will be treated with either the Zip device or sutures, and     thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be     removed prior the first follow up call day 10. The duration of the investigation is estimated     to 5 months, including a 4-month recruitment period and 1-month follow up period.   "
6590|NCT03199625|"     Cognitive behavioral therapy (CBT), which includes cognitive therapy (CT) and behavioral     therapy (BT), is the first-line treatment for patients with panic disorder (PD). However, the     neural mechanism of CBT is unknown. The exploration of mechanism is of great significance for     clinical strategy formulation. This study is proposed on the basis of our early PD and CBT     neuroimaging studies, adopt the design of prospective randomized controlled intervention     study, set up three time points: before the treatment（week 0）, the initial treatment (week     4th), the plateau treatment (week 28th). With normal subjects as black control and     antidepressant therapy as intervention comparison, this study set up CT and BT two     intervention groups, respectively collect all the participants'symptomatological,     psychological, cognitive function and brain imaging data (3D,DTI, fMRI in resting and tasks     states) at week 0, week 4th and week 28th. This study is based on the advanced analysis     methods we applied in the early study,including BOLD-fMRI, DTI, topological characteristics     analysis of the whole brain network and Granger causality test etc. It is from the point of     multiple levels(brain regions, circuits, whole brain), multimodal (structure, function) to     comprehensively analysis the role of CT and BT for the function and structure of brain     regions, circuits (mood regulating circuit and cognitive control network for emotion     processing) and whole brain in patients with PD. Totally, we explore the target area, path     and mechanism of CBT for emotion processing neural circuits in patients with PD, and combined     with the clinical data we preliminarily explore the imaging biomarkers of different     intervention methods which may predict therapeutic effect.   "
6666|NCT03198624|"     This is a single and multiple dose, parallel group study to assess safety and     pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.   "
10971|NCT03142282|"     This study is a randomized phase II trial of maintenance chemotherapy versus consolidative     radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic     colorectal cancer (MCRC).   "
6591|NCT03199612|"     The advent of continuous flow (CF) pumps for patients with severe heart failure has led to     marked improvements in survival; however, pump operation remains fraught with adverse     thrombotic events. This climbing rate of thrombosis and stroke during CF pump support has led     to a recent warning by the US Food and Drug Administration. Despite a rising incidence of     pump thrombosis and its downstream complications of stroke, the hematologic mechanisms behind     these devastating adverse events remain uncertain. Recently, it has been recognized that CF     pump induced hemolysis precedes and is associated with thrombosis. In-vitro studies show     increased platelet function with exposure to products of hemolysis, which is also known to     occur in diseases of intravascular hemolysis such as sickle cell anemia. This proposal will     investigate if hemolysis associated increased platelet function can be reduced by a     potentiation of nitric oxide signaling by an oral phosphodiesterase-5 inhibitor, sildenafil.     Elucidating mechanisms of hemolysis induced thrombosis may inform best strategies for     prevention of end organ damage and maintaining optimal CF pump operation.   "
6592|NCT03199599|"     Prospective validation of a prognostic model based on advanced PET/CT image analysis in non     small cell lung cancer   "
6593|NCT03199586|"     First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X     28 days followed by a 14 day rest period.   "
6594|NCT03199573|"     The proposed study will assess the current sun safety policies and practices in programs for     young children and to determine the willingness of stakeholders to incorporate more     protective measures.      The primary hypothesis is that children in Head Start programs, daycare programs, elementary     schools, or summer camps are exposed to significant UV radiation throughout the day, and are     not adequately protected with sunscreen, hats, or sun-protective clothing. The secondary     hypothesis is that these programs value sun safety as an important health behavior, but     probably do not have the funding avilable to make it a priority.   "
6595|NCT03199560|"     A randomized controlled double-blinded study comparing the intraoperative injection of     lymphatic mapping agents Tc 99m tilmanocept to Tc 99m filtered sulfur colloid in breast     cancer patients undergoing breast conservation and sentinel lymph node biopsy   "
6596|NCT03199547|"     Though maternal and neonatal health are high priority areas for international development,     maternal and neonatal mortality remain unacceptably high. Worldwide there are 1 million     maternal and 4 million neonatal deaths every year and half of them occur in sub-Saharan     Africa.      Post-partum and neonatal severe bacterial infections, namely sepsis, are leading causes of     maternal and neonatal deaths in sub-Saharan Africa. Newborns can be infected during labour -     when passing through the birth canal - and also during the first days/weeks of life, as a     consequence of the close physical contact with the mother, when the latter carriers bacteria.     As the mother is an important source of bacterial transmission to the newborn, treating     mothers with antibiotics during labour should decrease their bacterial carriage and therefore     lower transmission to the newborn. As carriage is a necessary step towards severe disease,     this intervention should in turn result in the lower occurrence of severe bacterial disease     and mortality during the neonatal period.      In many high-income countries, pregnant women are screened during pregnancy for vaginal     carriage of Group B Streptococcus, the bacteria responsible for the vast majority of neonatal     sepsis in the developed world. If women are carriers, they are treated with intravenous     antibiotics during labour to decrease the risk of severe disease to their off-spring.     Although this intervention has been successful in developed countries, infrastructure and     resource limitations in regions like sub-Saharan Africa prevent both screening and use of     intravenous antibiotics. Also, in Africa several bacterial pathogens are responsible for     neonatal sepsis and the antibiotics needed in the continent should cover a wider number of     bacteria; and ideally cover also bacteria responsible for severe post-partum disease in the     mother.      We will conduct a large trial in West Africa, The Gambia and Burkina Faso, with the main     objective of determining if a single dose of an oral antibiotic given to women during labour     decreases newborn mortality. The trial will also assess the effect of the antibiotic on     lowering newborns and maternal hospitalization during the first week's post-partum. We have     selected an antibiotic (azithromycin) that in sub-Saharan Africa has already been used for     elimination of other prevalent diseases such as trachoma. This antibiotic is safe, requires a     single oral administration, has no special storage requirements and has the potential to     eliminate most of the bacteria commonly causing severe disease in newborns and post-partum     women in the continent. Very important this antibiotic is not widely used in clinical care in     the continent, and therefore, any temporal increase of resistance induced by the intervention     should not have implications on current treatment guidelines.      Before going to the large trial proposed here (12,500 women to be recruited), we have     generated robust preliminary data on the effect of the intervention in a proof-of-concept     trial conducted in The Gambia (829 women and their offspring recruited). We found that in     fact, babies born from mothers who had taken this antibiotic during labour were less likely     to carry bacteria that can potentially cause severe disease. These babies were also three     times less likely to have bacterial skin infections or umbilical infections, both highly     common among African newborns. Besides, fever or mastitis (again both very common in the     region) during the post-partum period were four times lower among mothers who had taken the     antibiotic during labour. Such trial confirmed our hypothesis of impact on bacterial     transmission but it was too small to assess the effect of the antibiotic on mortality and     hospitalizations. The preliminary trial also showed that women from the azithromycin group     were less likely to need antibiotics for treatment infections during the puerperal period,     decreasing then the pressure on the scarcity of antibiotics available in the continent.      The advantages of our approach are its simplicity, low cost and the possibility of protecting     both mothers and babies with the same intervention.   "
6597|NCT03199534|"     This study assesses whether the addition of chemodenervation to an established regimen of     pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves     patients' objective and subjective outcomes. Study subjects will select one of two treatment     approaches: injection of 50 units Botulinum toxin A with local sedation as an office     procedure, or injection of 150 units Botulinum toxin A while anesthetized.   "
6598|NCT03199521|"     This study will assess the effect of apixaban on thrombotic status in patients with atrial     fibrillation.In addition it will compare apixaban to aspirin and warfarin on their effect on     endogenous fibrinolysis.   "
6599|NCT03199508|"     Nocturnal enuresis is common problem in children who are from 5 to 18 years old and do not     spontaneously urinate at least 2 times a week for more than 3 months. It can lead to major     distress for the children and their parents. The investigators hypothesize that the 3-day     voiding diary as the same as the 7-day voiding diary could be a diagnostic tool to provide     information on the diagnosis and classification of nocturnal enuresis. The purpose of this     study is to investigate the reliability and sensitivity of 3-day versus 7-day voiding diary     to diagnose nocturnal enuresis.   "
6600|NCT03199495|"     Contrast to conventional Western medicine, traditional Chinese medicine is the most common     used therapy of complementary and alternative medicine. Taiwan inherits traditional Chinese     culture, and the people popularly accept traditional Chinese medicine for general diseases.     However, most patients with acute or critical illness are used to admit to emergency     department for medical services, and then transfer to the department of related specialist     for further treatment. During the course of staying at emergent observation room, some     diseases do not meet the criteria of admission and keep for evaluation. The longer of staying     at emergent observation room the more waste medical resources.      The Chinese medicine department of Changhua Christian hospital has treated patients, who     consulted us at their own dispense, with subjective discomfort but remained at the emergent     observation room. Detailed contents of this study include the Chinese and Western medicine,     pharmaceutical, nursing cooperation mode, monitoring clinical effect of treating of the     patients diagnosed with intestinal obstruction or ileus who complain about nausea, vomiting,     abdominal pain, abdominal distension or constipation.And the patients were assigned to the     control and treatment group. Then we give the treatment group with the electroacupuncture     treatment,and the control groupe with the Chinese medicine seeds and the transcutaneous nerve     stimulation (no power).The patients were diagnosed with objective analysis of tongue     diagnosis, pulse diagnosis, heart rate variability, and questionnaire of pain. Hope that we     can assess the efficacy of both two different treatment,and also assess the cost of medical     care, and try to complete the syndromes statistical analysis of traditional Chinese medicine     for abdominal pain, building the relevance of Chinese medicine physical assessment teaching     and clinical efficacy.      The most important of this clinical teaching is that, this is a good opportunity for Chinese     medicine and Western medicine to cooperate with each other at the emergency department to     confirm the efficacy of traditional Chinese medicine, not only in the field of chronic or     geriatric diseases, but also in the field of emergency with the evidence base. This factually     achieves communication and integration of Chinese and Western medicine, and benefits the     public.   "
6601|NCT03199482|"     A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on     post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with     symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study   "
6604|NCT03199443|"     Prospective observational study.      A substantial number of patients do not respond favourably to sacral neurostimulation (SNS)     although clinically, they appear to have the same lower urinary tract (LUT) dysfunction     characteristics as the good responders. This may be due to methodological issues (lead     position) or patient selection. The purpose of this study is to improve and standardize lead     position, in order to increase the patient response to test stimulation and to SNS treatment,     and to decrease adverse events.      This studie consist out of two parts. In this second part (for the first part the examiners     refer to NCT03194425), the examiners will monitor EMG activity during tined lead test     procedures and the response on different needle positions will be evaluated until a close     match with the optimal template is found. The lead will then be placed in that position.     Comparison will be made between left and right side to evaluate any possible influence of     asymmetrical sacral innervation. The clinical effect will be evaluated on voiding diaries     after 3 weeks of sacral neuromodulation treatment (end of tined lead test phase), and also     with validated questionnaires (King's Health Questionnaire (KHQ) and Pelvic Floor Inventories     Leiden (PeLFis). Furthermore, pelvic floor EMG activity will be measured again. If > 50%     improvement is achieved compared to baseline, patients will proceed with the implantation of     an implantable pulse generator and clinical response will be evaluated by voiding diary and     questionnaires, coupled to pelvic floor EMG measurement after 6 months and 1 year.   "
6609|NCT03199378|"     The goal of this proposal is to collect normative data from a sample of ethnically diverse     Florida elders on a brief, standardized neuropsychological test battery . The norms collected     in this multi-cultural dataset will provide appropriate corrections for demographic and     sociocultural variables that contribute to performance variance on neuropsychological tests.     By accounting for these variables, the normative corrections will improve specificity and     eliminate disparities in diagnostic validity and clinical utility of neuropsychological tests     when administered to Florida's ethnic minority elders.   "
6610|NCT03199365|"     The goal of this research study is to learn about factors that may affect healthy eating and     physical activity for Latino families in Houston. Researchers will use this information to     design a program to encourage healthy behaviors.   "
6611|NCT03199352|"     The technique of laparoscopic Roux-en-Y gastric bypass (RYGB) has evolved significantly over     the past few decades to minimize complication risks such as strictures. Three different     anastomotic techniques are currently widely used hand-sewn (HS), linear-stapled (LS) and     circular stapled (CS). Studies are contradictory as to the best technique to avoid     complications. Many studies have focused on the stricture and infection rates of these     procedures, and minimized the examination of ulceration, gastritis, and anastomotic leak. The     purpose of this study is to prospectively examine how the use of linear-stapled and hand-sewn     anastomotic techniques affect complication rates of marginal ulceration, gastritis, leak and     stricture in patients who undergo RYGB. The goal of this study is to compare the long-term     complication rates between hand-sewn robotic RYGB and linear-stapled laparoscopic RYGB.     Eligible patients are men and women age 19-65 who are to undergo RYGB, have a BMI between     35-45, and RYGB is the primary procedure. The main outcomes to be measured are complications     in marginal ulceration, gastritis, leak, and stricture rate at 2 and 6 weeks, and 3, 6, 9,     12, and 24 months postoperatively.   "
6612|NCT03199339|"     The primary objective of the study is to evaluate the safety and tolerability of single and     multiple doses of TBA-7371 in healthy subjects   "
6613|NCT03199326|"     This study evaluates the feasibility, acceptability, and impact of a collaborative care     practice for infants investigated by state Child Protective Services (CPS) for suspected     maltreatment. Recognizing the vulnerability of infants referred into CPS in the first year of     life, as well as the frequent contact of infants with health care providers in the first year     of life, the investigators will conduct a RCT to measure the impact of a collaborative     practice model linking CPS caseworkers with primary health care providers during an     investigation for suspected infant maltreatment. With this trial, the investigators will ask     (3a) Can a collaborative practice model improve parent-reported infant health-related quality     of life 6 months following child welfare involvement for suspected infant maltreatment? and     (3b) Does a collaborative practice model impact repeat child welfare involvement for     suspected child maltreatment over 6 months?   "
6614|NCT03199313|"     This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted     at one study center in the United States. Four (4) cohorts of 8 subjects each (6 active and 2     placebo). Subjects will participate in only one cohort.      Safety will be assessed throughout the study; serial ECGs and serial blood samples will be     collected for the safety and PK assessment of sutezolid.      Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor,     in conjunction with the Principal Investigator, has determined that adequate safety,     tolerability and PK from the previous cohort has been demonstrated to permit proceeding to     the next cohort.      Interim PK analyses will be performed for the dose escalation decisions to reconsider the     sampling time points as the study progresses. All samples will be sent for analysis and the     bioanalytical lab will be unblinded and only run the analysis on active treatment subjects.     Data from the analysis used for the escalation meetings will only include active treatment     subjects, and will be blinded by subject.      Subjects will be housed in the clinic from at least 24 hours prior (from Day -2), until 48     hours (Day 3) after dosing. Subjects will be contacted via a phone call for follow-up     questioning about adverse events 7 days later (Study Day 10).   "
6615|NCT03199300|"     Cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or     pulmonary toxicity. Why some patients are susceptible to extreme toxicity of cancer treatment     is largely unknown. Unraveling extreme cardiovascular toxic responses in cancer patients may     help understand the pathophysiology of cardiovascular toxicity of these agents and help in     understanding the more subtle, long-term cardiovascular side effects that affect a larger     part of cancer survivors. With induced pluripotent stem cells we will obtain patient-derived     cells to recapitulate and mimic and study pathological (cardiovascular) responses and     (cardiovascular) toxicity in vitro.   "
6616|NCT03199287|"     Infective endocarditis (IE) is an infection of cardiac valves. IE mainly involves bacteria,     more rarely fungi. IE is an uncommon diseases with an estimated incidence of 1-12 cases per     100,000 inhabitants per year. The diagnostic of IE relies on the culture of biological     samples (blood cultures and per-operative samples) in the bacteriology laboratory in order to     identify the pathogen and its susceptibility to antimicrobials. Nonetheless in about 10% of     the cases, the blood cultures remain negative, due to antibiotics taken before harvesting, to     non-culturable bacteria or to aseptic phenomena.      Clinical metagenomics is defined as the application of high-throughput sequencing (NGS)     followed by a specific bioinformatics analysis to obtain clinical information, i.e. pathogen     identification and the prediction of their susceptibility to antimicrobials. The metagenome     of a sample (i.e. all the genomes of the organisms present) virtually contains all the     information necessary for bacteriological diagnosis: what is the pathogenic bacteria , and to     which antibiotics it is susceptible.      Hence, using clinical metagenomics in the context of IE appears seducing in order to overcome     the limitations of conventional methods based on culture. Here, we propose to assess the     performance of clinical metagenomics in the diagnostic of IE.   "
6617|NCT03199274|"     This randomized pilot clinical trial studies how well perflutren protein-type A microspheres     and contrast-enhanced ultrasound work in improving response to radioembolization therapy in     patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A     microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced     ultrasound imaging will pop these microbubbles and cause tumors to become more sensitive to     radiation therapies.   "
6618|NCT03199261|"     Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder     in healthy subjects.   "
6619|NCT03199248|"     Digital mucous cysts (DMCs) are a benign rubbery cystic lesion which usually involve the     dorsal or lateral side of DIP joint (digital interphalangeal joint) or proximal nail fold.     The most successful treatment way is surgical management. However, which may cost time,     require expertise, may cause infection, prolong wound healing and sometimes may lead to the     joint movement limitation. The investigator bring this new technique: percutaneous     capsulotomy for digital mucous cysts, which is easy and quick, last but not least, low     recurrence rate.   "
6620|NCT03199235|"     The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky     Iron Fish™ (LIF) utilization among families with young children in a Latin American community     with a high prevalence of iron deficiency and iron-deficiency anemia.   "
6621|NCT03199222|"     A common problem for the intermediate preparatory stage of prosthetic rehabilitation is     distal pressure, due to commonly compromised sensation and lack of understanding how to     address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin     breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent     this common problem among rehabilitating amputees, smart socket technology has been developed     to better identify problems that may occur. The Smart Socket Technology including Prompting     (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses     distal pressure, which is novel to the technology. When excessive pressure is sensed on the     residual limb, it will send a signal to the user's smart phone to make an adjustment. This     prompting improves patient interaction and may prevent problems as a result of common volume     fluctuation and compromised sensation. The purpose of this clinical trial is to determine if     the ALPS iForce smart socket technology with prompting (SST+P) will improve patient     interaction, usability, comfort, fit, function and health economy outcomes compared with the     standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces   "
6622|NCT03199209|"     The goal of this research study is to learn if participating in a program with another family     member in their household can help participants eat healthier and become more physically     active.   "
6623|NCT03199196|"     The goal of this research study is to learn if enrolling in a program with a partner that     involves monitoring each other's physical activity and providing support to one another can     help both participants be more physically active.   "
6624|NCT03199183|"     Takayasu arteritis(TA) is a chronic progressive vasculitis predominantly affecting the aorta     and its major branches. The demographic, clinical and prognostic features of Takayasu     arteritis in China remains in uncertainties. Investigators aim to setup a national     registration study for Takayasu arteritis, to observe the prevalence, clinical     manifestations, natural history, survival, progression, diagnostic and therapeutic methods of     the disease in China.   "
6636|NCT03199027|"     Following the announcement of the global 90-90-90 strategy, there is a huge need in South     Africa for effective well-developed scaled-up models of ART (anti-retroviral therapy)     delivery that aim to improve patient adherence and viral suppression. The ART adherence club     is one such model of service delivery. We are conducting a pragmatic randomised control trial     to compare virological outcomes 12 months post-ART initiation between arms: those referred to     the Adherence club at 4 months post-ART initiation (early referral) and those referred to the     Adherence club at 12 months post-ART initiation (delayed referral). Those with delayed     Adherence club referral will continue to attend the ART clinic as per the Standard-of-Care.   "
6637|NCT03199014|"     The purpose of this study is to determine whether prolonged inflation time on drug-eluting     stents deployment for ST-elevation myocardial Infarction was better than conventional stents     deployment.   "
6717|NCT03197961|"     This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and     FTC in healthy women comparing the drug levels and activity in the absence (first phase) and     then the presence (second phase) of DMPA. The investigators will recruit 12 healthy women     aged 18-45 who are HIV-negative and at low risk for acquiring HIV.   "
6626|NCT03199157|"     The investigators designed a prospective randomized study to investigate the effect of     fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level     laminectomy/discectomy.   "
6627|NCT03199144|"     The goal of the present study is to test if in situations of borderline resectable patients a     neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase     the median OS rates above 30 months that means at least 12 months more than the 18-20 months     generally described.   "
6628|NCT03199131|"     Chronically elevated pulmonary pressures do not immediately result in right ventricular     failure. During the initial period of exposure, the RV adapts to the increased afterload by     altering its metabolism and morphology so as to meet the increased work requirement. Several,     interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a     switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased     production of mitochondrial reactive oxygen species. While adaptation is initially successful     in many cases, it is temporary, and after an uncertain period of time, the ventricle begins     to fail. This transition from a compensated to decompensated state is difficult to predict     clinically, and patients with different etiologies of CPOS progress to overt RV failure over     significantly different time periods. This variability hinders the implementation of     treatments that are tailored to a specific disease stage.   "
6629|NCT03199118|"     This research will be conducted in an attempt to achieve complete root coverage with     physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich     fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.   "
6630|NCT03199105|"     Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general     anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this     study, the investigators will enroll male patients undergoing elective noncardiac surgery     with urinary catheterization after anesthetic induction, and compare preoperative education     with cartoon illustrations combined with local tetracaine mucilage vs. local tetracaine     mucilage alone in alleviating CRBD during the post-operative period.   "
6726|NCT03197844|"     The purpose of this study is get to know what and how Xinyuan capsule in hospital results in     drug-induced liver injury or adverse drug reactions from a cohort event monitoring as     registration research.   "
6727|NCT03197831|"     The Patient Protection and Affordable Care Act (PPACA) came into law in 2010. Originally,     according to the Act, a state would lose its federal Medicaid funding if it did not expand     its Medicaid eligibility to include all persons earning below 138% of the federal poverty     level on January 1, 2014. However, in a Supreme Court Case in 2012 this was ruled as     unconstitutional and Medicaid expansion in 2014 was made optional. Twenty four states and the     District of Columbia opted to expand their Medicaid programs on January 1, 2014 and the     remaining 26 states opting against it. Section 1115 of the Social Security Act allows states     to alter the federal Medicaid requirements to promote the overall state Medicaid program.     Among those states that expanded Medicaid Arkansas, Arizona and Iowa adopted approved Section     115 Waivers to expand their Medicaid programs. The variability in the states' decisions     regarding Medicaid expansion presented researchers with the opportunity to study the impacts     of Medicaid expansion on various facets of health care.      There is a growing body of evidence suggesting that implementation of the coverage expansions     under the PPACA and Medicaid expansion led to significant decreases in rate of uninsured     persons, increase in access to health care and improvements in affordability of healthcare.     Along with improving access and affordability of health care, the PPACA aimed at reducing the     growth rate of health care expenditures by reducing wasteful use of resources such as     preventable inpatient and emergency department (ED) visits. According to previous research,     access to primary care and insurance coverage are significantly and negatively associated     with experiencing preventable inpatient and ED visits. Historically, racial/ethnic minorities     have had lower rates of access to primary care and insurance and higher rates of preventable     inpatient and ED visits which might change with implementation of PPACA. Within states that     have expanded Medicaid, adopting different methods of expansion may also impact patterns of     inpatient and ED utilization and disparities in those. In the current political scenario and     looming uncertainty over the future of PPACA and the possibilities of modifying the PPACA it     might benefit policy makers to gain knowledge on the early impact of Medicaid expansions and     different approaches to expanding Medicaid under the PPACA. This study seeks to determine the     impact of Medicaid expansion and different types of Medicaid expansion on overall and     preventable inpatient and ED utilization and disparities in those through a three-state     comparison between Kentucky, Arkansas and Florida.      Another major reform under PPACA was in the area of substance use disorder treatment. Despite     the high societal burden exerted by patients with substance use disorders treatment rates     among them have been low. The most common reasons cited for the poor access to treatment have     been lack of insurance coverage. The PPACA required all insurance plans sold after January 1,     2014 to cover substance use disorder treatments. Additionally, plans were required to cover     screening, brief intervention and referral to treatment for substance use disorders. This     might potentially lead to changes in treatment rates and sources of payments for substance     use disorder treatment. Further, the promotion of integration between substance use disorder     treatment and primary care might lead to increased referrals by healthcare professionals to     substance use treatment. Thus, in this study we also seek to assess the impact of Medicaid     expansion on admission to substance use disorder treatment facilities and changes in sources     of payments and rate of health care referrals to those treatment facilities.   "
6632|NCT03199079|"     Preterm birth is a leading global cause of neonatal mortality despite of numerous advances     and intensive research in perinatal medicine. Almost one million children die each year due     to complications of preterm birth and in almost all countries with reliable data, preterm     birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of     disability, including learning disabilities, visual and hearing impairments. Spontaneous     preterm delivery (SPTD) is often multi factorial event, precocious cervical softening,     shortening and dilatation are a common denominator. The majority of preterm births happen     spontaneously, though some are due to early induction of labor or cesarean birth, typically     due to medical maternal of neonatal conditions.   "
6633|NCT03199066|"     The Czech National Lymphoma Registry (NiHiL) was founded to monitor epidemiologic data and     improve the diagnostic evaluation and quality of treatment of patients with non-Hodgkin´s     lymphoma (NHL).      The patients are registered into the registry in anonymized form. For each patient are     available: registration form, diagnostic form, treatment form, follow- up form, and other     malignancy form.      Data quality in the NiHiL has been checked by audits. The data is analyzed according to NHL     subtypes with endpoints: lymphoma distribution, epidemiological data, prognostic     characteristic, treatment characteristics, response rate, relapse rate, mortality, PFS, OS,     DFS, Lymphoma specific survival, longterm toxicity.   "
6634|NCT03199053|"     The purpose of this research study is to evaluate the efficacy and safety of the drugs     dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18     years old and are currently taking metformin, insulin, or both drugs.      Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged     18 years or older. This study will assess how well dapagliflozin and saxagliptin work by     finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a     pill that contains no active drug), in children and adolescents. Dapagliflozin and     saxagliptin are considered investigational products in this study since while they have been     approved for use in adults (patients 18 years or older), they haven't been approved for     children and adolescents due to lack of clinical studies in this specific population.      Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who     do not have this disease. The high level of sugar in the blood can lead to serious short-term     and long-term medical problems. The main goal of treating diabetic patients is to lower blood     glucose to a normal level. Lowering and controlling blood glucose help prevent or delay     complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the     possibility of amputation.      Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the     kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the     kidneys from returning glucose from the urine back into the bloodstream.      Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a     hormone made by the pancreas that allows the body to use sugar (glucose) from the food that     is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood     sugar levels in response to a meal and between meals if blood glucose levels are not lowered     effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps     to decrease the amount of sugar made by the body. Together, these processes reduce blood     glucose levels and help to control Type 2 Diabetes.      Dapagliflozin (alone or in combination with other antidiabetic drugs) has been shown to be     effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use     in adults (patients 18 years or older) in approximately 40 countries worldwide including the     USA and Europe. Dapagliflozin has not yet been studied in children (pediatric patients).      Saxagliptin (alone or in combination with other antidiabetic drugs) has been shown to be     effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use     in adults (patients 18 years or older) in approximately 90 countries worldwide. Saxagliptin     also has not yet been studied in children (pediatric patients).      The subject will either receive one of the active study drugs or a placebo (a pill that looks     identical but contains inactive drug). This study will be double blind; this means that     neither the subject, nor the study doctor will know which treatment the subject will receive.      Which treatment the subject receives is decided by a computer, purely by chance; this is     called a random assignment.      For this study, there will first be a screening phase of up to 6 weeks, followed by a 2 week     lead in phase. Thereafter there will be a 26 week short-term treatment phase (week 1-week     26), and a 26 week long-term treatment phase (week 27-week 52). Following this there will be     a follow-up telephone call on week 56 and a post study visit at week 104.      At day 1 visit after the lead in phase the subject will be randomly assigned to receive one     of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or placebo in a blinded manner. This     treatment will continue up to week 14. Then after week 14, and until the end of the study,     the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5     mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg or placebo in a blinded manner.     The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups     will receive them at a higher dose.      After completion of the 26-week short-term phase, the subject will enter a 26 week long-term     phase. The same treatment that the subject had been assigned to at week 14 visit will be     continued. This long-term phase is primarily designed to provide additional information on     how well dapagliflozin and saxagliptin are tolerated.      Following the treatment phases, there will be a follow-up telephone call at week 56.      The subject will be asked to visit the clinic at week 104 again for a final evaluation of the     physical development (based on the stage of puberty).   "
6635|NCT03199040|"     This is a single institution, open-label randomized phase 1 trial of neoantigen DNA vaccine     alone vs. neoantigen DNA vaccine plus durvalumab in triple negative breast cancer (TNBC)     patients following standard of care therapy. Patients with newly diagnosed clinical stage     II-III TNBC are eligible for enrollment. Patients will receive standard of care therapy     including chemotherapy, surgery and radiation therapy as clinically indicated. Following     standard of care therapy, patients will be randomized to receive either a neoantigen DNA     vaccine alone, or a neoantigen DNA vaccine + durvalumab.   "
6638|NCT03199001|"     Fabry Disease (FD) is a rare, X-linked lysosomal storage disorder leading to left ventricular     hypertrophy, myocardial fibrosis, arrhythmia and heart failure. Cardiac involvement is the     leading cause of death in FD. Treatment with enzyme replacement therapy is expensive, may be     poorly targeted and there are difficulties in early detection and disease monitoring. T1     mapping signal change is a potential remarkable biomarker for FD.      Fabry400 is a multicentre study aiming to understand the biology of Fabry Disease and its     relationship to non-invasive multi parametric mapping by CMR.   "
6639|NCT03198975|"     Microvascular invasion (MVI) has been well demonstrated as an unfavorable prognostic factor     for hepatocellular carcinoma (HCC), and patients with MVI have a high risk of tumor     recurrence after curative hepatectomy. Currently, the diagnosis of MVI is determined on the     postoperative histologic examination, which greatly limits its influence on preoperative     decision making. Therefore, we constructed this prospective study to develop a machine     learning-based model for preoperative prediction of MVI by extracting high-dimensional     magnetic resonance (MR) image features.   "
6640|NCT03198962|"     There are two stages in the study. In Stage 1, 2000 Thai MSM, MSW and TGW/TGSW will be     screened at the Thai Red Cross Anonymous Clinic (TRCAC) or Besides walk-in clients of TRCAC,     potential participants could be referred to TRCAC by Rainbow Sky Association of Thailand     (RSAT), Service Workers In Group (SWING) Foundation and Sisters Foundation. Each participant     will complete a short standardized questionnaire on risk behavior, including use of     amphetamine-type stimulants (ATS) and other drugs. HIV testing will be done following usual     HIV testing and counseling (HTC) guidelines. Stage 1 will collect data on ATS use in the     community. The results from stage 1 will also be used to stratify participants for inclusion     in stage 2 of the study.      Participants from the screening will be invited to participate in stage 2 of the study, which     is the longitudinal cohort study. Recruitment will be stratified by HIV status and ATS use as     listed in to ensure an adequate number of ATS users for data analysis. Participants in stage     2 will follow-up every 6 months for 18 months.   "
6641|NCT03198949|"     This is a prospective, randomized, double-blind, placebo-controlled cross over study designed     to evaluate the efficacy and safety of everolimus (trough 5-15 ng/mL) given as adjunctive     therapy in patients with focal cortical dysplasia type II who already failed more than two     antiepileptic drugs and surgery.      This study will assess the impact of everolimus to placebo on seizure frequency in focal     cortical dysplasia type II. The number of patients who experience seizure reduction of 50% or     more will be counted during last 4 weeks of each core phase.   "
6642|NCT03198936|"     Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement.   "
6643|NCT03198923|"     The purpose of this study is to assess the safety and effectiveness of natural killer (NK)     cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung     cancer.   "
6644|NCT03198910|"     The collected data from the Zurich Registry for pulmonary Hypertension (PH) are evaluated in     a retrospective analysis. This study examines the number of patients and their exact     diagnoses who are treated at the University Hospital of Zurich and potentially other     participating in the Zurich Registry. Other demographic parameters such as age, gender and     body-mass-index are also part of the evaluation. Furthermore, the analysis will focus on the     newest guidelines on PH. Therefore, it will be checked how many patients would fulfill the     therapeutic goals in terms of New York Heart Classification (NYHA), 6-minute walk distance,     sign of right heart failure and N-terminal pro-brain-natriuretic peptide(NTproBNP).     Additionally, the study examines on how the patients are treated. Despite the different kind     of Drugs, the focus lies on the combination therapy (single, double, triple) and the impact     the therapy had on the patients.   "
6645|NCT03198897|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of homozygous     familial Hypercholesterolemia from plasma   "
6646|NCT03198884|"     A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of     Darunavir, Ritonavir, and Dolutegravir   "
6647|NCT03198871|"     The primary goal of this study is to assess the utility of a postoperative intravenous     acetaminophen dosing schedule in minimizing postoperative pain, opioid consumption and     opioid-related side effects. Investigators also aim to study overall patient satisfaction and     cost-effectiveness (direct and indirect costs) of this regimen as part of Enhanced Recovery     After Surgery protocol at the University of Pittsburgh Medical Center (UPMC) Presbyterian     Hospital, a tertiary care hospital and level one trauma center.   "
6648|NCT03198858|"     CartoUnivu™ module easily integrates into the workflow of PVI with the endpoint of     unexcitability of the ablation line without prolonging the procedure time. It is associated     with a marked reduction in fluoroscopic dose when compared to a conventional 3D-mapping     system.      The aim of this prospective randomized study is to evaluate during pulmonary vein isolation     (PVI) for paroxysmal atrial fibrillation (PAF) whether the use of the IIM is: 1. feasible, 2.     can help to reduce fluoroscopy time and burden and 3. has an influence on the procedure     duration.      Study design Prospective, randomized controlled multicenter trial, open label. Randomization     1:1   "
6649|NCT03198845|"     To investigate the effects of video game play therapy in patients with knee osteoarthritis   "
6650|NCT03198832|"     Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory     etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity     of PD, and this may contribute to the overall inflammatory burden of the individual,     influencing the natural course DM2. The aim of this study is to establish whether individuals     with DM with or without chronic periodontitis have an increase in oxLDL and what is the     influence of periodontal treatment in the reduction of oxLDL with consequent improvement in     Diabetes Mellitus parameters.   "
6651|NCT03198819|"     The correct timing and technique of neural tube defect (NTD) repairs significantly decreases     the morbidity and mortality of NTD cases. However, infections related to the surgery are     still common. We investigated the effects of topical rifampicin (RIF) combined with routine     prophylaxis in newborns with open NTD.   "
6718|NCT03197948|"     This pilot clinical trial studies how well electronic patient reported outcomes work in     measuring health-related quality of life in patients with stage I-IV prostate cancer     undergoing treatment. Using a smartphone application to measure and monitor symptoms before,     during, and after treatment may help patients better detect, understand, and manage their     health.   "
6652|NCT03198806|"     The need to restore water losses resulting from physical activity has become established and     diffused into international consensus for healthy individuals or high-performance athletes.     However, the influence of fluid replacement when administered during and after exercise on     cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of     effort and pain of individuals with autonomic alterations known as the coronary arteries     remain poorly understood. In this sense, this study intends to investigate the influence of     hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective     perception of exertion and pain of coronary arteries submitted to aerobic exercise in the     model of a cardiovascular rehabilitation session. A total of 31 individuals will be recruited     in this study and will perform two standardized cardiovascular rehabilitation sessions. Only     in the second session will the volunteers be instructed to ingest a quantity of water     predetermined by the evaluator, based on the loss of body mass measured in the first session.     The outcomes (autonomic modulation, cardiorespiratory variables and perceptions) will be     evaluated before, during and after exercise. The results of this study will enable     professionals working with this population to implement awareness strategies on the     importance of fluid intake in cardiovascular rehabilitation programs.   "
6653|NCT03198793|"     Essential hypertension (HTN) is a disease that affects approximately 1 billion individuals     worldwide. Despite the availability of effective and safe anti-hypertensive drugs, 65% of     subjects diagnosed with HTN do not have their blood pressure (BP) controlled (<140/90 mmHg).     The overall incidence of resistant HTN, (defined as requiring 3 or more anti-hypertensive     drugs, including a diuretic, to control BP) is estimated to be 15% of the hypertensive     population. Consequently, there is a pressing unmet medical need to develop new classes of     anti-hypertensive drugs that act on alternative pathways and further control BP and the     associated cardiovascular risks in subjects.      The prevalence of HTN in African Americans in the United States is among the highest in the     world, and HTN is more common in African Americans than in Caucasians. One of the risk     factors for HTN is sodium sensitivity. There is a higher association of HTN with sodium     sensitivity in African American subjects and other racial/ethnic groups who are     overweight/obese.      Effective agents to treat HTN in this high-risk population are clearly needed.      This study will be conducted in a hypertensive, overweight subject population of multiple     ethnic origins in which QGC001 is likely, based on its mode of action, to demonstrate a     significant anti-hypertensive effect.   "
6654|NCT03198780|"     To establish the feasibility of a tool that monitors and motivates people with COPD to     complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at     home.   "
6655|NCT03198767|"     The purpose of this study is to determine if LIK066 taken with a meal containing low     carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to     assess the potential effects of supplements such as psyllium or calcium carbonate on     alleviating diarrhea associated with LIK066.   "
6656|NCT03198754|"     A sample of 60 patients scheduled for HSCT in the treatment of MM will be recruited in the     weeks to months prior to their hospitalization. Light therapy incorporating ambient     systematic programmed light illumination (sPI) will be used in patient hospital rooms (during     scheduled transplant) to control cancer-related fatigue (CRF). The FDA has certified that     light therapy, like that used in this study, is a low-risk intervention. When admitted to the     hospital for a stem cell transplant, there will be a light fixture in the hospital room which     we will be testing to see how it may affect cancer related fatigue, sleep quality, and other     negative side effects often seen with the transplant and subsequent treatment. The light     fixture will turn on and off by itself in the morning. There are two treatment arms used in     the study, each of the arms uses different light intensities. The study treatment received,     i.e. which of the two lights, will be chosen by chance, like flipping a coin. There is an     equal chance of being given each study treatment. Participants will not be told which study     treatment they are getting until after the study is completed. Each light will be turned on     from 7 AM to 10AM every day during transplantation. While in the hospital assessment of     fatigue, sleep activity, depression, circadian rhythms, and quality of life will continue     through the course of hospitalization (14-21 days of treatment, to determine immediate impact     of sPI), then repeat at one month and three months post-discharge follow-ups (to determine     lasting effects). Outcomes will be assessed through standardized scales (e.g., FACIT-Fatigue     Scale) and objective measures (e.g., actigraphy, daysimeter for light monitoring, melatonin     from urine collection, blood inflammatory markers, all explained below). This trial will: 1)     be the first randomized clinical trial (RCT) to investigate the effects of sPI to prevent CRF     and other biopsychosocial side effects of transplant; 2) focus on a distinct, relatively     homogenous patient population (MM-HSCT patients) with high prevalence of CRF; and 3) explore     possible circadian rhythm mediation via melatonin analysis and blood analysis. This     investigation will have major public health relevance as it will determine if an inexpensive     and low patient burden intervention (sPI) is able to control fatigue associated with medical     illnesses and related problems.   "
24839|NCT02960555|"     The goal of this clinical research study is to learn if isatuximab can help to control     smoldering multiple myeloma (SMM). The safety of this drug will also be studied.   "
6657|NCT03198741|"     Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with     coronary artery disease. However, antiplatelet therapy may have adverse consequences, the     most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The     extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has     not been studied, principally due to the lack of sensitive, noninvasive measurements capable     of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE)     is a non-invasive, active controlled system which affords assessment of the stomach and     entire small intestine.The current randomized study will assess gastrointestinal mucosal     injury and bleeding via AMCE in patients on three different antiplatelet regimens and     establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding     optimal antiplatelet agent usage after PCI.   "
6658|NCT03198728|"     This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety     study in adult hypogonadal men. The study duration is 12 months (365 days), including a     90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.   "
6659|NCT03198715|"     The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic     stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by     intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is     determined that each dose is safe and tolerable, the next higher dose will be given to the     next group.   "
6685|NCT03198377|"     Purpose      The purpose of this study is to determine whether application of Transcutaneous Electrical     Nerve Stimulation (TENS) is effective on habituation to electrical current whether delivered     at a fixed frequency of 100 Hz or at patterned frequency. The secondary purposes are to     determine the effectiveness on mechanical pressure pain and the subjective perception of the     subjects regarding habituation and comfort of the different stimulations.   "
10740|NCT03145324|"     To collect the immunisation history of participants enrolled in a previous vaccine study (REC     09/H0604/107) in order to assess the influence of genetic variation on the level of immunity     to routine immunisations.   "
6660|NCT03198702|"     In children population with obstetrical brachial plexus palsy (OBPP), shoulder     musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder     motion, pain and a reduction in social participation. Some uncontrolled studies shows that     early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which     cause the deformity) are one of the most promising treatment for the prevention of bony     deformity.      The main objective of this study will be the evaluation of the effectiveness of BTI in the     internal shoulder rotator muscles at the age of 12 months in preventing an increase in     posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of     11 months and 18 months), compared to the Sham group.   "
6661|NCT03198689|"     The purpose of this study is to assess feasibility, safety and preliminary efficacy of     Brentuximab vedotin (Adcetris), a CD30-directed monoclonal antibody (anti-mitotic monoclonal     antibody), in the treatment of early active diffuse cutaneous systemic sclerosis (dcSSc).   "
6662|NCT03198676|"     A safety study to compare the effect of two different formulations of PrEP-001 nasal powder     when dosed in healthy subjects   "
6663|NCT03198663|"     Black young men who have sex with men (BYMSM) are at high risk for contracting and     transmitting HIV, and represent a priority population for developing effective interventions.     Within the House Ball community (HBC), a clandestine subculture of the Black gay community,     HIV is highly stigmatized. This stigma, coupled with high HIV prevalence rates and elevated     levels of undiagnosed/untreated HIV infection, places BYMSM in HBCs at incredible risk for     HIV infection. Community-level interventions that target social norms, behavior, and stigma     in the HBC are sorely needed in order to make a broader impact among BYMSM. Building on prior     work in the community, this study proposes to launch an innovative     Effectiveness-Implementation Hybrid Type 2 trial to examine the effectiveness and     implementation of a community-level HIV prevention intervention (called POSSE) based on     popular opinion leader (POL) models across two cities with similar HBCs, Chicago and     Philadelphia. The proposed study has two specific aims: 1) To determine the effectiveness of     a POL intervention, POSSE, to decrease sexual risk behavior (UAI), STIs and HIV stigma among     BYMSM in the HBC; and 2) To evaluate the processes, strategies, barriers and facilitators for     the implementation of POSSE delivered across two distinct metropolitan areas with high HIV     prevalence among BYMSM and similar House Ball Communities. To examine these aims, the     investigators will first use social network strategies to identify, screen, and recruit POLs     (n=75) from the Philadelphia HBC. The investigators will then gather baseline behavioral and     biological (HIV/STI testing) data in both Chicago and Philadelphia (n=100 BYMSM per city) and     train the Philadelphia POLs to implement the POSSE intervention. The investigators will     conduct an implementation-focused process evaluation to assess fidelity to the POSSE     intervention; number, content, spread, and acceptability of risk reduction messages; age     appropriateness of the messages; acceptability of the overall intervention; and     barriers/facilitators to implementation. Next, the investigators will complete follow-up     assessments every 6 months post- intervention in both cities (n=100 BYMSM per city at each     assessment point). The investigators will also assess behavior change in those delivering the     intervention (POLs) at each assessment point. The investigators will conduct     implementation-focused qualitative interviews with POLs (n=15) and community participants     (n=30) from Philadelphia. Last, the investigators will implement POSSE in Chicago by     repeating the steps outlined above, continuing assessments in both cities, and conducting     qualitative interviews in Chicago.   "
6664|NCT03198650|"     This is a multicenter, open-label Phase 1 study of acalabrutinib, a selective and     irreversible Bruton's tyrosine kinase inhibitor, in Japanese adult patients with advanced     B-cell malignancies. This study is divided into 2 parts: Part 1 (dose-confirmation phase) and     Part 2 (dose-expansion phase).   "
6665|NCT03198637|"     The main objectives of the prolonged resuscitation paralysis are usually adaptation to     mechanical ventilation, lower insufflation pressures and cough suppression.      The use of monitoring during the prolonged neuromuscular blockade is the subject of     recommendations. Its interest is subject to a recommendation grade B and its use in     prevention of overdose is associated with a recommendation of Grade C.      However, many practitioners continue to objectify the depth of neuromuscular blockade and     reversal by simple clinical evaluation. This is a subjective estimate of the depth of     neuromuscular block.      Resuscitation in several pharmacokinetic parameters are taken into account. First, the drug     distribution volume is usually increased in the Intensive Care patient and requires an     increase in initial doses to obtain the same pharmacological effect.      Then, unlike a short-term administration, the administration of neuromuscular blocking agents     on days causes diffusion in peripheral compartments. Their diffusion coefficients are slower     which contributes to the increase of the elimination period after interruption of the     administration of curare. There is therefore a risk of residual paralysis.      Secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte     disorders and acid-base, administration of certain drugs, the inter- and intra-individual     variability and tachyphylaxis (form tolerance of particularly rapid installation during a few     close administration, linked to the proliferation of cholinergic receptors).      The value of monitoring neuromuscular blockade in intensive care is the prevention of     overdose and in finding the lowest effective dose.   "
6667|NCT03198611|"     Objectives: To study the prognostic value of the evolution of diastolic function according to     fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of     mortality (ICU and hospital) and mortality at 90 days.      2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left     ventricular systolic and diastolic) in septic shock.      B) Incidence and reversibility of diastolic dysfunction according to the echocardiographic     criterion used.      C) Incidence and reversibility of right ventricular systolic dysfunction.   "
6668|NCT03198598|"     In this study the investigators will evaluate the effects of yoga practice on multiple     sclerosis patients and healthy controls for fatigue, quality of life, movement, cognition,     brain activity, self-efficacy, stress, anxiety, depression, affective states and     immunological response. To investigate the effects of yoga training delivered by a yoga     instructor or through a smartphone application, the investigators will use a multidimensional     approach that comprises of: evaluation of neuropsychological, quality of life and affective     aspects, structural and functional magnetic resonance imaging, functional near infrared     spectroscopy (fNIRS) combined with movement analysis (gait, strength, balance etc.) and     analysis of the immune response.   "
6669|NCT03198585|"     To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and     during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and     health-related quality of life in stable, symptomatic heart failure patients with reduced     left ventricular ejection fraction.      The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce     the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).   "
6670|NCT03198572|"     The purpose of this study is to evaluate the efficacy and safety of berberine treatment on     Non-alcoholic Steatohepatitis.   "
33878|NCT02842346|"     The aim of our study was to investigate the correlation between the umbilical resistance     index and weight gain during the third trimester of low-risk pregnancies.   "
6672|NCT03198546|"     The third generation of CAR-T cells that target GPC3 (GPC3-T2-CAR-T cell)have been     constructed and their anti-HCC function has been verified by multiple in vitro and in vivo     studies.Clinical studies will be performed to test the anti-cancer function by the     GPC3-T2-CAR-T cells in human HCC patients with GPC3 expression.In this phase I study, the     safety,tolerance, and preliminary efficacy of the GPC3-T2-CAR-T cell immunotherapy on human     will firstly be tested.   "
6673|NCT03198533|"     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective     randomized clinical trial.   "
6674|NCT03198520|"     To evaluate the change in patient Oral Health-related Quality of Life (OHRQoL) from wearing a     cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360TM     polymer Removable Partial Denture (RPD) for 8 weeks.   "
6675|NCT03198507|"     The test and treat strategy for treating dyspeptic patients who are H. pylori positive is     rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a     new triple therapy to treat H. pylori infection in dyspeptic patients against an active     comparator.   "
6676|NCT03198494|"     The objective of this study is to test the feasibility and physiological effect of     low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy     patients. The long-term goal is to develop this protocol for daily, long-term use in a home     setting, for nocturnal seizure and IED suppression   "
6677|NCT03198481|"     The decision making process for stress incontinence surgery is complex. A key gap in the     literature is how to improve patient preparedness and satisfaction for mid-urethral sling     (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap.     The specific aims of the proposed research: (1) is to develop two videos to counsel patients     who have elected to undergo a MUS surgery. One video will be created from a patient-centered     perspective using peers as counselors. The second will employ a traditional counseling     approach; (2) To compare the impact of multimedia counseling between women randomized to a     patient-centered counseling versus a traditional counseling video. The investigators will     recruit patients who present with stress urinary incontinence who elect to undergo a MUS     procedure. Women will be randomized during their pre-operative visit to watch the     patient-centered or traditional counseling video before they are counseled regarding their     upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a     patient centered-video will report higher satisfaction, less decisional regret, greater     preparedness, and less anxiety as measured by validated scales. Successful completion will     improve understanding of patient's needs and will allow development of improved educational     tools readily available to the AUGS community.   "
6678|NCT03198468|"     This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal     Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic     cancer in the lung. Patients who have consented to participate in this study (enrolled) will     be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C     procedure. Only patients that meet all of inclusion criteria and none of the exclusion     criteria will receive vapor ablation treatment.      Patients will receive BTVA-C treatment followed by standard-of-practice surgical resection.   "
6679|NCT03198455|"     Asthma and allergy is increasing in Norway and Western countries. Treatment is still mostly     symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as     Andosan™, have been shown to protect against asthma and allergy in murine models by changing     the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune     system. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway. Blood     donors and possibly patients with pollen-derived allergy and asthma will be included in the     study.The aim is to examine whether Andosan™ i) has similar clinical effects against allergy     and asthma in man as it has in mice, and ii) reduces drug use and increases frequency of     blood donations. Blood donors or patients who are recruited with informed consent will be     given Andosan™ or placebo orally as add-on treatment to ordinary treatment for 7 weeks during     the Birch pollen season, and specific IgE will be measured before, during and after the     intervention, in addition to basophil activation testing and filling out of a questionnaire.   "
24840|NCT02960542|"     This pilot study is designed to adapt a community-based diabetes prevention program to reach     adults at risk for cancer.   "
6680|NCT03198442|"     Breast PET may be able to help in the diagnostic pathway in patients to determine which ones     need to go on to have a second look ultrasound +/- biopsy and those who need to be sent for     MRI guided biopsy. This may reduce the need to create more anxiety and uncertainty in this     group of patients, already extremely stressed by the recent diagnosis of breast cancer.This     study involves a single trial visit the Royal Free Hospital for imaging. Participants will     need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI.     They will be advised not to take part in this study if they are unable to lie flat on their     back and their front for this length of time or if they are claustrophobic. They will be     offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to     the trial.   "
6681|NCT03198429|"     The current cluster randomized trial examines the efficacy of embedding two different     parenting interventions within child protection services for young children (0 to 4) who have     been exposed to domestic violence and who are at moderate to high risk for recurrent     experiences of maltreatment. Interventions are embedded in recognition of the significant     role played by child protection case workers in identifying families in need of intervention,     referring/engaging families in intervention, and being able to use information resulting from     intervention (e.g., reports from the intervention program, observations of parenting     behaviour changes made as a result of intervention) to improve decision-making in their child     protection practice. Thus in this trial, ongoing child protection case workers for families     are randomly assigned to receive professional development training, supervision support, and     priority client access to parenting interventions in the following four conditions: a)     embedded mother-child dyadic intervention (Mothers in Mind); b) embedded fathering     intervention (Caring Dads); c) both mother-child dyadic and fathering intervention; d)     service as usual.      Mothers in Mind (MIM) is a dyadic mother-child intervention aimed at preventing child     impairment resulting from exposure to domestic violence. Intervention focuses on increasing     mothers' awareness of the impact that exposure to family violence/trauma may have had on     their infants and themselves as mothers, helping identify and promote positive parenting     skills such as sensitivity and responsiveness to infant needs, promoting parental competence     and emotional closeness and decreasing mothers' social isolation. Mothers in Mind uses an     attachment and trauma-informed psycho-educational process approach in 12 weekly sessions (10     group and 2 individual).      Caring Dads (CD) aims to prevent recurrence of child exposure to domestic violence by     intervening with fathers. Caring Dads includes 15 group sessions, an individual intake, and     two individual sessions to set and monitor specific behaviour change goals. Major aspects of     innovation in the Caring Dads program include the use of a motivational approach to engage     and retain men in intervention, consistent emphasis on the need to end violence against     children's mothers alongside of improving fathering; program content addressing     accountability for past abuse; focus on promoting child-centered fathering over developing     child management skills; and a model of collaborative practice with child protection.      Hypotheses are posed for differential outcomes among child protection workers (level of     randomization) and for children who are the subject of the child protection referral (nested     within workers). At the level of the individual child (primary outcome) it is hypothesized     that there will be lower rates of re-referral for children of families on the caseloads of     child protection workers assigned to the embedded CD, MIM and combined intervention than for     those on the caseloads of workers in the service as usual condition. At the worker level     (secondary outcomes), outcomes are hypothesized in two areas: 1) worker skill in     conceptualizing risk and need in cases of child exposure to domestic violence and 2)     increased self-efficacy for referring to and collaborating with embedded interventions.     Specifically, we hypothesized that following training and at 12-month follow-up, workers in     the CD/MIM intervention and combined CD and MIM condition will have greater case     conceptualization skills in responding to hypothetical cases as compared to workers in the     treatment as usual condition. We further hypothesize that assignment to an intervention     condition will lead workers to report greater self-efficacy for collaborating with embedded     parenting interventions than workers in the treatment as usual condition post-training and at     12-months follow-up.   "
6682|NCT03198416|"     This is a single-arm study involving the use of a high resolution manometry (HRM) diagnostic     device that is not utilized in any clinical decision-making processes. All patients scheduled     for DISE as part of their regular clinical care will be screened for enrollment via described     inclusion and exclusion criteria.   "
6683|NCT03198403|"     The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative     pain after total knee arthroplasty   "
6686|NCT03198364|"     Schizophrenia and bipolar disorder are associated with high risk for suicide, yet there are     few brief interventions that directly target suicide prevention in this large population. The     goal of this intervention development study is to evaluate the feasibility, acceptability,     and preliminary effectiveness of a brief intervention called SafeTy and Recovery Therapy     (START) that is augmented with content delivered on mobile devices outside of the clinic     setting. The intervention will evaluated in a community urgent care center context as people     initiate outpatient care, and, if effective, could be deployed in a wide network of such     centers.   "
6687|NCT03198351|"     Primary Objective:      To evaluate any potential increase in the risk of major birth defects, in the first year of     life, in teriflunomide-exposed pregnancies.      Secondary Objective:      To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy     outcomes including any potential pattern of minor birth defects, spontaneous abortion,     stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.   "
6688|NCT03198338|"     The Transversus Abdominis Block (TAP) block is known to be an effective means of reducing     patient pain after abdominal surgery. In the meantime, the general TAP block has been studied     in patients who were in the recovery room and the ward after surgery. The purpose of this     study was to determine the effect of pain reduction and opioid saving effects in patients     with TAP block in ICU settings.   "
6689|NCT03198325|"     Prospective, open-label, single arm, non-randomized, proof-of-concept study. Eligible     patients will sign a written informed consent and will be followed-up at screening, baseline     (ART interruption) and at 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at     ART resumption.      The study visits will include: general clinical assessment, routine laboratory tests     including: creatinine, phosphorus, calcium, alkaline phosphatase, AST, ALT, fasting glucose,     total cholesterol, HDL- and LDL-cholesterol, triglycerides, CD4+ cell count and CD4+/CD8+     ratio.      Additional 30 mL of peripheral blood will be withdrawn at study visits for further     virological, and immunological investigations and for bio-banking purposes.      During follow-up, the occurrence of two consecutive HIV-1 RNA values >50 copies/mL or the     occurrence of stage B or C AIDS-defining events or any serious non-AIDS clinical event at     least potentially related to treatment interruption will be criteria for ART resumption.      All patients with HIV-RNA<50 copies/mL at week 48 (end of the study) will resume their     baseline ART regimen.      The main demographic, clinical and therapy information will be accurately recorded at the     study visits in an electronic Case Report Form.   "
6690|NCT03198312|"     Develop a prospective, multicenter, randomized, open, parallel controlled noninferiority     clinical trial to evaluate the efficacy and safety of CathiportTM implantable drug delivery     device   "
6691|NCT03198299|"     Using double blind, randomized controlled design to study the short-term therapeutic effects     of customized arch support insoles on children   "
6692|NCT03198286|"     This pilot clinical trial studies how well the Carevive Survivor Care Planning System works     in improving quality of life in breast cancer survivors. A personalized survivor care plan     includes a summary of a patient's cancer treatment and a customized survivor care plan and     may provide beneficial information and resources.   "
6693|NCT03198273|"     The aim of the study is to determine the effects of clinical Pilates Exercises on the level     of pain, functional status, flexibility, static and dynamic endurance of the truncus muscles     and quality of life in patients with lumbar disc herniation.   "
6694|NCT03198260|"     Aims & objectives:        1. The aim of the study is to find out the influence of fascial manipulation on running          kinematics among athletes with medial tibial stress syndrome (MTSS).        2. The objectives of our study are      i. To use fascial manipulation as a mode of treatment in MTSS. ii. To compare running     kinematics before and after treatment intervention. iii. To compare pain perception before     and after treatment intervention.   "
6695|NCT03198247|"     The purpose of this study is to test whether adding a treatment using pain neuroscience     education (PNE) and coping skills training (CST) to usual care, in subjects with knee     osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty     (TKA), is more effective than only usual care. There is a high evidence level of different     systematic reviews, which support the efficacy of physiotherapy treatments combined with     behavioural techniques aimed to reduce pain catastrophism, pain and disability in other     pathologies. The primary aim of that kind of interventions is to help the subjects to     reconceptualise its own pain understanding and its role on the recovery process, as well as     promoting an increase of activity and encourage the subject to resume its usual activity     instead of continuing to avoid it.   "
6728|NCT03197818|"     The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed     combination of extrafine beclometasone dipropionate plus formoterol fumarate plus     glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well     as to assess its safety.   "
8816|NCT03170518|"     The purpose of this study is to assess the effect of canagliflozin relative to placebo on     glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and     tolerability of canagliflozin after 52 weeks of treatment.   "
6696|NCT03198234|"     A significant number of patients with hematologic malignancies need a hematopoietic stem cell     transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor,     the remaining patients will require an HSCT from a mismatched related or unrelated donor.     Almost 60% of these mismatched donor HSCTs will result in graft-versus-host disease (GvHD),     which can cause significant morbidity and increased non-relapse mortality. GvHD is caused by     the donor effector T cells present in the HSC graft that recognize and react against the     mismatched patient's tissues.      Researchers and physicians at Lucile Packard Children's Hospital, Stanford are working to     prevent GvHD after HSCT with a new clinical trial. The objective of this clinical program is     to develop a cell therapy to prevent GvHD and induce graft tolerance in patients receiving     mismatched unmanipulated donor HSCT. The cell therapy consists of a cell preparation from the     same donor of the HSCT (T-allo10) containing T regulatory type 1 (Tr1) cells able to suppress     allogenic (host-specific) responses, thus decreasing the incidence of GvHD.      This is the first trial of its kind in pediatric patients and is only available at Lucile     Packard Children's Hospital, Stanford.      The purpose of this phase 1 study is to determine the safety and tolerability of a cell     therapy, T-allo10, to prevent GvHD in patients receiving mismatched related or mismatched     unrelated unmanipulated donor HSCT for hematologic malignancies.   "
6715|NCT03197987|"     Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and     colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy.     In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma     detection rate during colonoscopy.   "
19611|NCT03028870|"     The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily     compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.   "
6697|NCT03198221|"     This is a prospective randomized study which will be done at main campus Cleveland Clinic.     The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale     in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be     randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a     low volume bowel preparation (sodium picosulfate, magnesium oxide and anhydrous citric acid     (P/MC)). Both agents will either be administered as full dose the evening before or as     split-dose on the evening before and on the day of the procedure.   "
6698|NCT03198208|"     Fentanyl is the most commonly used opioid during anesthesia at Massachusetts General     Hospital. Compared to other opioids, e.g. sulfentanil and remifentanil, fentanyl's     pharmacokinetic properties are more problematic as the context sensitive half-time increases     with duration of fentanyl infusion. This may lead to respiratory complications particularly     in patients who receive fentanyl for surgical procedures of long duration. Considering the     common use of fentanyl during surgery and its duration of action that is hard to predict     during long surgical procedures, we will evaluate the association between intraoperative     fentanyl dose and postoperative respiratory complications within 3 days of surgery.   "
6699|NCT03198195|"     A protocol named as CIP-2015 for patients with Wiskott-Aldrich Syndrome may reduce the rate     of GvHD.      The details of the protocal followed with:        1. Conditioning regimen Busulfan 16 mg/kg in total, Fludarabine 160 mg/m2 in total.        2. GvHD Prophylaxis:      Rabbit antihuman thymocyte globulin 7.5 mg/kg post-transplant cyclophosphamide (CY) (50     mg/kg.d on days +3 and +4) Cyclosporine or tacrolimus, mycophenolate mofetil, on days +5   "
6700|NCT03198182|"     The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the     effects the drug has on the body   "
6701|NCT03198169|"     This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial     products on the complete healing of chronic wounds.   "
6702|NCT03198156|"     1. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance          in subjects with central hypersomnia without cataplexy.        2. To determine the effects of tDCS on subjective measures of sleepiness and alertness in          subjects with central hypersomnia without cataplexy.   "
6703|NCT03198143|"     This study evaluates the effect of the hunger hormone ghrelin on human decision-making.     Participants will be given an injection of ghrelin or saline on different study days and will     then be asked to make a series of computer-based decisions. The investigators hypothesize     that ghrelin will increase participant's preference for energy-dense foods and will also     increase impulsiveness in decision making.   "
6704|NCT03198130|"     This study is being conducted to compare the relationship of patient response to treatment to     changes in tumor microenvironment.   "
6705|NCT03198117|"     This study including two parts，one part is a randomized clinical trial design，another part is     a registration study.   "
6706|NCT03198104|"     This is a prospective observational study which will recruit up to 100 paediatric     participants over a period of 30 months to determine whether MRI is as accurate at detecting,     distinguishing, and monitoring liver disease as current standard of care techniques such as     liver biopsy and fibroscan.   "
6707|NCT03198091|"     This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin     Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin     Ning has a better effect on different subgroup patients with certain characteristics.   "
6708|NCT03198078|"     To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of     adolescents with schizophrenia.   "
6759|NCT03197402|"     This leucine-enriched protein gummy (as a gummy bar/slab) will be studied to address     age-related loss of muscle mass and strength/function in older persons. The product is small     volume (approximately 35 g per serve) and low energy (approximately 100 kcal per serve). It     is easy to chew and swallow with the consistency of a firm Jello. In addition, it contains an     effective dose of leucine in a high-quality protein matrix consisting of milk proteins.     Understanding the efficacy of this product on changes in levels of blood amino acids and the     molecular signaling required to enhance muscle growth will provide helpful insight for the     suggestion of supplemental use.   "
6921|NCT03195283|"     This study aims to investigate whether a novel meal service FoodforCare (FfC), comprising     6-protein-rich meals a day following proactive advice from a nutritional assistant, improves     dietary intake and patient satisfaction, compared to the traditional 3-meals a day service     (TMS).   "
6709|NCT03198065|"     Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally     invasive surgery has become the main stay for treating of many surgical diseases. After the     booming in the advancement of surgical instrument and breakthrough in surgical skills, the     minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast,     thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and     effective, and further it achieves compatible results and outcomes in oncology and functional     diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has     been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and     bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy,     and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel     disease). Under a superior heritage of surgical skills from Taiwan university hospital, we     introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the     mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our     hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years,     single-incisional laparoscopic surgery has emerged to become one of the focused topic in the     world and seemly in our department. Through single-incision surgery, we attempted to minimize     the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical     experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate     two-step plans: first, by retrospective data collection, we can explain the clinical problems     based on current statistical results. Second, based on prior (step 1) retrospective findings,     a prospective study could be conducted for more evident results.   "
6710|NCT03198052|"     The third generation of CAR-T cells that target PSCA, MUC1, PD-L1, or CD80/86 have been     constructed respectively and their anti-cancer function has been verified by multiple in     vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function     of the these individual or combination of the CAR-T cells for immunotherapy of human cancer     patients with PSCA, MUC1, PD-L1, or/and CD80/86 expressions.In this phase I study, the     safety,tolerance, and preliminary efficacy of the PSCA/MUC1/PD-L1/CD80/86-CAR-T cell     immunotherapy on human cancers will firstly be tested.   "
6712|NCT03198026|"     This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in     treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as     obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's     lymphomas.   "
6713|NCT03198013|"     The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its     marker specific PD in relation to Prednisolone in healthy male subjects   "
6714|NCT03198000|"     This is a single center, double-blinded study designed to demonstrate the therapeutic     equivalence of over-the-counter eye drops in healthy adults with red eyes.   "
6716|NCT03197974|"     The aim of this study is to improve outcomes in people with bipolar disorder (BD) by     comparing two new online interventions specifically designed to improve quality of life     amongst people who have had multiple (10 or more) episodes of BD.   "
6719|NCT03197935|"     This is a global Phase III, double-blind, randomized, placebo-controlled study designed to     evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed     death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and     cyclophosphamide (nab-pac-AC), or placebo and nab-pac−AC in participants eligible for surgery     with initial clinically assessed triple-negative breast cancer (TNBC).   "
6720|NCT03197922|"     This study is comparing 2-week and 1-week versions of a multidisciplinary intervention for     encopresis (MIE), consisting of both medical and behavioral components to treatment as usual     control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed     and treated for any constipation or other potential medical complications. Following this,     individuals randomly assigned to one of the treatment groups start attending daily     appointments in clinic for either 1 week or 2 weeks. At appointments, the behavior team     implements structured sits on the toilet to promote independent bowel movements (BMs). If an     independent BM does not occur, the study team will administer a suppository to promote rapid     release of the bowels and prompt the child to remain on the toilet following administration.     In doing so, continent bowel movements are predictably evoked while the child is on the     toilet, allowing for reinforcement with praise and preferred toys/activities. Eventually,     suppositories are gradually decreased until the child is having BMs independently. Caregivers     are trained to continue implementing the intervention following the clinic-based portion.      The purpose of the current study is to evaluate MIE using a large randomized clinical trial     (RCT), addressing the Department of Defense Autism Research Program, Area of Interest of     Therapies to Alleviate Conditions Co-Occurring with autism spectrum disorder (ASD). The     researchers will recruit 150 children diagnosed with ASD, randomizing them to 2 weeks of MIE     , 1 week of MIE, or treatment as usual (TAU) consisting of behavioral consultation and     medical intervention. This study will evaluate MIE compared to TAU and determine the optimal     treatment length.   "
6721|NCT03197909|"     Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is     usually progressive and associated with an enhanced chronic inflammatory response in the     airways and the lung to noxious particles or gases. It is associated with an atrophy of the     skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this     muscle atrophy have not been elucidated, and the spill-over theory has recently emerged.     Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade     inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute     the cellular micro-environement of the muscle fibre - could activate the mechanisms of the     cell atrophy.   "
6722|NCT03197896|"     This clinical trial studies how well an educational intervention works in increasing     knowledge about prostate cancer in high-risk neighborhoods. Learning about prostate cancer     and the pros and cons of screening for prostate cancer may increase knowledge about prostate     cancer while decreasing anxiety and concerns about prostate cancer screening.   "
6723|NCT03197883|"     To evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in     healthy female participants with mild to advanced photo-damaged facial skin who have     undergone a 70% Glycolic Acid facial peel procedure.   "
6724|NCT03197870|"     The purpose of this study is to evaluate the safety and efficacy of subcutaneously     administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with     moderate to severe non-proliferative diabetic retinopathy (NPDR).   "
6725|NCT03197857|"     The aim of this project is to investigate in obese patients the changes induced by bariatric     surgery on the various components of the physical condition and their postoperative evolution     following an intervention combining a physical activity program (aquabike vs bicycle) with or     without protein supplementation.   "
6729|NCT03197805|"     The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists     (CAP) recommend that HER2 status (negative or positive) must be determined in all patients     with invasive breast cancer. The knowledge of HER2 status will help the oncologist in     prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used     to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ     hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative     or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed     using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4     ≤HER2 gene number copy <6), the patient is eligible to an anti-HER2 therapy after discussed     during MD-MM. This decision should be individualized on the basis of patient status     (comorbidities and prognosis) and patient preferences after discussing available clinical     evidence.      Based on molecular classification, RNA expression could help to discriminate breast cancer     subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a     genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the     expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow     determining the HER2 status.      This study was designed in order to define if such a test could help the oncologist to define     the better therapeutic decision in a HER2 equivocal population. In addition, concordance     tests will be performed. The aim of this study is to assess the modification decision rate     between the first and the second multidisciplinary decision-making meeting in HER2 equivocal     patients using genomic testing.   "
6730|NCT03197792|"     The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of     the composite outcome of persistent organ dysfunction plus death in patients undergoing     elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. The     investigators' hypothesis is that the portal vein pulsatility fraction, measured using     transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is     proportional to the risk of developing subsequent end-organ dysfunction in the postoperative     setting.   "
6734|NCT03197740|"     The objective of this study is to evaluate the efficacy and safety of donepezil transdermal     patch in patients with mild to moderate Alzheimer's disease.      The primary objective is to demonstrate the non-inferiority of the test drug, IPI-301     (donepezil transdermal patch), to the comparator, Aricept tablet, after 24 weeks of treatment     in patients with mild to moderate Alzheimer's disease in terms of improvement in cognitive     function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) and     in terms of global assessment as assessed by Clinician's Interview Based Impression of Change     plus Caregiver Input (CIBIC-plus).   "
6735|NCT03197727|"     This study compares the associated risk factors between adults with tooth wear and age- and     sex-matched controls without tooth wear.   "
6736|NCT03197714|"     Phase Ib, open-label, dose-escalation clinical trial to evaluate the best-tolerated doses in     Acute Myeloid Leukaemia (AML) relapsed or refractory to chemotherapy.      This open-label, nonrandomized trial will comprise 2 stages. A dose escalation stage will     characterize the safety, tolerability and maximum tolerated dose (MTD), of OPB-111077.      Subsequently, an expansion stage will further evaluate the safety and antitumor activity of     OPB-111077 in AML relapsed or refractory to chemotherapy.      Enrollment to the expansion cohort will begin following determination of the MTD.      Approximately 6-12 patients will be included in the phase I part of this clinical trial.      Additional patients will be included in the expansion cohort up to a total of 15 patients.     The expansion cohort will serve to further evaluate safety simultaneously with preliminary     efficacy.   "
6737|NCT03197701|"     The general objective of this project is to determine the best method to measure maximal     inspiratory flow rates, to study their reproducibility and create reference equations in     healthy subjects.   "
6738|NCT03197688|"     The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety     profile of Opsumit and to describe clinical characteristics and outcomes of patients newly     treated with Opsumit in the post-marketing setting. It is expected that the recruitment     target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit     new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry     with retrospectively identified first-time Opsumit users in order to achieve the desired     sample size.   "
6739|NCT03197675|"     Of the more than 250,000 Americans with severe spinal cord injury (SCI), 42,000 are military     veterans. The Department of Veterans Affairs is the largest single network of SCI care     providers in the nation. Patients with SCI experience functional disabilities as well as     chronic pain. Studies show that individuals with SCI report pain refractory to conventional     treatments. Civilian and veteran patients with SCI have associated pain with impairments in     physical and cognitive function, sleep, employment, social relationships, community     re-integration and quality of life. In a survey of individuals with SCI, those who used     acupuncture experienced a reduction of pain symptoms lasting hours after treatment, with     27.3% reporting pain relief for days. A pilot study on the use of auricular acupuncture for     neuropathic pain associated with SCI showed a greater reduction of pain as measured by the     Numerical Rating Scale (NRS). A recent review of randomized controlled trials regarding the     use of acupuncture in SCI found that only two of sixteen included studies were of high     quality. There was limited evidence for the use of acupuncture in motor functional recovery,     bladder function recovery, and in pain control related to SCI. Further high quality studies     are needed. This proposal is for a phase II randomized clinical trial.   "
6740|NCT03197662|"     The investigators propose a phase 2 randomized double blind 8-week treatment trial of     intranasal OXT vs. placebo in 50 subjects aged 5 to 17 years with PWS in order to assess     IN-OXT's affect on measurements of (1) eating behaviors (2) repetitive behaviors (3) weight     and body composition (4) quality of life (5) salivary OXT and hormone levels (including     ghrelin, pancreatic polypeptide, peptide YY, GLP-1, insulin, glucagon, testosterone, and     estrogen). If superior to placebo, this data will add to the current knowledge that OXT is an     effective treatment for hyperphagia as well as other symptoms of PWS.   "
6741|NCT03197649|"     Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while     comparing the treated areas to an untreated control area in the same patient.   "
8870|NCT03169803|"     A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac     Autonomic Nerve Stimulation (CANS) Therapy System   "
6742|NCT03197636|"     An observational single center study designed to identify response-related biomarkers of     anti-programmed death 1 (PD-1) therapy to advanced melanoma patients and to investigate if     vitamin D levels are related to treatment response. 40 patients diagnosed with advanced     melanoma will be included. Patients are included at the Department of Oncology, Aarhus     University Hospital (AUH). All patients will be treated with Pembrolizumab as a standard     procedure at the Department of Oncology. The protocol comprises blood samples at baseline, 3     and 6 weeks after treatment initiation with anti-PD1 therapy and three years of observational     follow-up. A total amount of 217 ml blood will be drawn during the study period. The study     period is 6 weeks followed by 3 years of follow-up. Medical history, symptoms, response to     treatment regarding the RESIST criteria and side affects will be recorded at each visit in     both the study period and in follow-up. Biochemical markers will be obtained according to     normal procedure during study and follow-up visits.      20 Healthy volunteers (HV) are included, matched by age and gender. Collected blood samples     (serum, plasma, peripheral blood mononuclear cells) will be analyzed after the last patient     has ended the week 6 visit.   "
6743|NCT03197623|"     A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose     Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women     with Osteopenia Secondary to Corticosteroids.   "
6744|NCT03197610|"     Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering     denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic     surgical operations is another method in covering denuded root surface. The aim of this study     is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete     root coverage rate and a newer method root coverage esthetic scoring system (RES).   "
6745|NCT03197597|"     This study focus on the genetic changes of B. pertussis clinical isolates. For this panels of     B. pertussis isolates has been collected during four periods in different European countries.   "
6746|NCT03197584|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with epithelial ovarian cancer who have progressed on or after SoC     therapy.   "
6750|NCT03197519|"     The purpose of this project is to conduct a multicentre, randomized controlled trial (RCT)     with 250 patients diagnosed with an eating disorder (ED). In this experiment, the patients     from the experimental group will test an mHealth application (TCApp developed by HealthApp)     and then, a clinical efficacy analysis and economic evaluations will be performed. To do     this, we have set the following three specific objectives:        -  To evaluate the clinical efficacy of an intensive intervention that includes both          standard face-to-face Cognitive Behavioural Treatment (CBT) (treatment as usual, TAU)          plus an online intervention using TCApp, versus TAU alone.        -  To carry out an economic evaluation (cost-utility and cost-effectiveness analysis) of          the new mHealth intervention and identify factors that promote or hinder the          implementation of TCApp in mental health settings in Spain.        -  To analyse the adoption processes of this type of applications by patients and health          professionals and identify the determinants of mHealth adoption.      General hypothesis:      The implementation of the intensive intervention program (TAU + TCApp) would result in a more     significant improvement of the ED symptoms compared to the TAU control group.      Specific hypotheses:        -  The application of the intensive mHealth intervention would lead to significantly          greater change scores (difference between T0 and T1, which will be also maintained at          follow-up, T2) in the primary outcome variable of ED psychopathology, compared to the          control group.        -  The mHealth intervention would lead to significantly greater change scores (difference          between T0 and T1, which will be also maintained at follow-up, T2) in patients'          secondary outcome variables: a) depression symptoms, b) anxiety symptoms, c) motivation          to change, d) suicidal risk, and e) quality of life, compared to the control group.        -  Similarly, intensive intervention would result in greater change scores (difference          between T0 and T1, which will be also maintained at follow-up, T2) in caregivers'          variables: a) quality of life and b) caregiver burden.   "
6751|NCT03197506|"     This phase II trial studies the side effects and how well pembrolizumab works in combination     with standard therapy in treating patients with glioblastoma. Drugs used in the chemotherapy,     such as pembrolizumab and temozolomide, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors.     Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy     may kill tumor cells.   "
6752|NCT03197493|"     This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of     carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of     carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who     successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will     use the two higher dose regimens of protocol 0002. these will be assigned according to how     well the higher dose was tolerated in protocol 0002.   "
6753|NCT03197480|"     To investigate whether ocular imaging and proteomic biomarkers; and systemic biochemical,     metabolomic, and genetic biomarkers predict treatment response to intravitreal aflibercept in     a cohort of patients with DME.      To identify if subjects with DME who do not have a rapid response to intravitreal     aflibercept, will benefit from intravitreal steroid therapy, and identify the biomarkers that     predict response to steroid therapy.   "
6754|NCT03197467|"     NEOMUN is designed as an open-label, single arm, prospective, monocenter, phase II study of     pembrolizumab in a neoadjuvant setting in patients with non-small cell lung cancer of Stage     II/IIIA suitable for curative intent surgery.   "
6755|NCT03197454|"     The primary objective of this study is to evaluate the effects of the experimental treatment     (cognitive training) further outlined in this protocol on the cognitive abilities (e.g.,     processing speed, attention, working memory, and executive function), brain functionality,     functional status and quality of life of individuals with age-related cognitive decline as     compared to a computer-based active control.   "
6756|NCT03197441|"     This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis.     Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also     receive second look surgery and intraoperative biopsy.   "
6757|NCT03197428|"     This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle     instability by comparing the imaging and clinical outcomes between patients receiving PRP and     those receiving whole blood during the modified Broström-Gould procedure.   "
6758|NCT03197415|"     This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back     pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal     injection of autologous PRP.   "
6769|NCT03197272|"     To evaluate the improvement in myopic refractive error and the corneal endothelial safety     with a corneal crosslinking treatment regimen for mild myopia. The treatment involves a 4-mm     central treatment zone in high oxygen environment without corneal epithelial debridement.   "
6760|NCT03197389|"     The study consists of 2 parts: a retrospective study, and a prospective clinical study with     pembrolizumab (Keytruda®) (Phase 0).        1. Retrospective study (S58910):           This is a retrospective analysis to study the expression of PD-L1 in ER/PR negative          breast tumors and to correlate this PD-L1 expression with tumor infiltrating lymphocytes          (TILs), proliferation, expression of apoptosis and clinical outcome (development of          distant metastases).        2. Phase 0 study:      This is a Phase 0 single center, open-label, non-randomized, study in patients with early     ER/PR negative breast cancer. Patients will be treated with one injection of Pembrolizumab     (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. This phase 0     study will consist of 2 cohorts; cohort A will include patients who are scheduled for upfront     surgery. Cohort A1 will include patients with Her2 negative tumors and Cohort A2 patients     with Her2 positive tumors. Cohort B will include patients who received neoadjuvant     chemotherapy (with anti-Her2 therapy if Her2 positive) and who have clear signs of residual     tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual     tumor size of at least 10 mm). Cohort B1 will include Her2 negative tumors and Cohort B2 Her2     positive tumors. The injection will be given in the oncological outpatient unit. Patients     will be monitored carefully for the development of adverse experiences/events. Adverse     experiences/events will be evaluated according to criteria outlined in the NCI Common     Terminology Criteria for Adverse Events (CTCAE), version 4.0.   "
6761|NCT03197376|"     This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at     the immune response in infants. In addition, the study will compare the immunogenicity of the     Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.   "
10961|NCT03142412|"     To develop a test to characterize and monitor SLE disease activity status from a     participant's home by analyzing the gene expression from participant self-collected blood     samples using a novel fingerstick collection kit.   "
6762|NCT03197363|"     The main goal of the study is to provide a unique multidimensional picture of the health of     the population with simultaneous optimal standards of sampling, processing and storing of     data and biomaterial that will allow discovering novel mechanisms in the development and     progression of common civilization diseases. In the effect it will improve prevention,     diagnosis and treatment.   "
6763|NCT03197350|"     The goals of this research will be to define some of the mechanisms underlying the     progression and complications of heart failure (HF) with preserved left ventricular ejection     fraction (HFPEF) Aim 1: to evaluate the differences in cardiac structure, function and     fibrosis markers through the spectrum of HF stages in order to deepen the understanding of     the pathophysiology driving HF progression.      Aim 2: to define the mechanisms by which HF risk factors, such as hypertension, diabetes,     obesity, and renal insufficiency, interact with age to increase HF risk, and to evaluate the     role of precipitating factors such as myocardial ischemia, atrial fibrillation in HFPEF.      Aim 3: to determine prognostic factors in HFPEF patients, by following these patients over     time. Accordingly the investigators will correlate baseline data (echocardiographic, MRI or     biomarkers) with incident cardiovascular events and determine whether these measures provide     incremental prognostic information beyond clinical characteristics.   "
6764|NCT03197337|"     Small-scale experiments conducted by our group have led to the hypothesis that Localized     Provoked Vulvodynia (LPV) may be due to laxity of the Utero-Sacral ligaments (USL). According     to this hypothesis, the pain experienced by women with LPV is due to the USL's inability to     provide appropriate support for the pudendal nerve.      In order to test this hypothesis we will conduct a single-blind randomized control trial in     which patients with LPV will undergo a pressure-test - pressure will be temporarily applied     to the posterior fornix using a speculum, thus strengthening the USL and adding support to     the pudendal nerve. While the pressure is being applied, the cotton-swab test will be     performed (palpating vulvar and vestibular sites using a cotton-swab), and each patient will     rate the elicited pain on a scale of 1 to 10 (1 - not painful, 10 - worst pain imaginable).      The results for each patient will be compared to their baseline level of pain (which will be     recorded in the beginning of the experiment) and to the level of pain they report while     inserting a speculum but not applying any pressure.   "
6765|NCT03197324|"     The purpose of this study is to examine the drug-drug interaction in your body when given the     study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate     whether bexagliflozin effects the amount of digoxin in your blood and how safe the study drug     is and how well the study drug is tolerated when taken with digoxin.   "
6766|NCT03197311|"     Surgical extraction of third molars is one of the most common outpatient procedures performed     by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the     standard of care practice to relieve symptoms of pain, swelling, and trismus after these     procedures. The majority of these patients do not return for follow up unless they experience     a problem. There is limited data on whether the patients use the narcotics as directed and     what is their practice of disposal of the remaining medications that were not consumed.      In this research the effectiveness of postop analgesic consumption, analgesic disposal     practice, pain control, and patient satisfaction will be compared between patients who are     randomized to the intervention group who will use a developed mobile application and a     control group who will not use the mobile app.   "
6767|NCT03197298|"     Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet     therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides     aspirin). This change is based on studies that showed benefits of ticagrelor. However, study     participants were only partly treated by percutaneous coronary intervention (PCI). In     patients who were treated by PCI, this was generally performed using of bare metal or     first-generation drug-eluting stents (DES).      CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we     evaluate the impact of the guideline suggested change in the primary DAPT regimen (from     clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with     newer-generation DES in the Thoraxcentrum Twente.   "
6768|NCT03197285|"     The aim of the present study is to value the effectiveness of an Eye-Cervical Re-education     Program (ECRP) to decrease pain and increase mobility in the cervical area compared to a     Combined Physiotherapy Protocol (CPP) in patients with chronic neck pain symptoms.   "
6771|NCT03197246|"     This study will provide further knowledge concerning the use of electrocardiography (ECG)     signals for verification of peripherally inserted central catheter (PICC) tip placement.     Furthermore, it will be investigating whether use of Intravascular ECG (IVECG) for this     verification is just as good as or even better than the current standard method with chest     X-ray. This can help promote a method that involves less radiation and increased safety for     patients, while at the same time saving resources. If use of ECG signals from the PICC tip is     an equally exact method for verification of correct PICC tip placement as chest X-ray     verification, the IVECG could replace chest X-ray control.   "
6772|NCT03197233|"     The objective of this study is to investigate if maternal intake of vitamins A and D from     food and dietary supplements during pregnancy, and infant supplementation with these     vitamins, are associated with development of asthma in the offspring.   "
6773|NCT03197220|"     : findings have been reported about the benefits of omega-3 fatty acids on decreasing the     incidence of cardiovascular disease (CVD). The objective was to compared the effects of     walnut (plant omega-3 fatty acid) and fatty fish (marine omega-3fatty acid) and their     combination on cardiovascular risk factors. In this clinical trail 99 over weight and obese     female adults were on three diets with fish (300 g), walnut (6 walnuts) or fish-walnut (150g     fish and 3 walnuts) for 12 weeks. Three diets were Low in calories and similar. Fasting blood     sugar, inflammatory markers serum lipids, coagulation factors (fibrinogen, D-Dimer), oxidant     markers and leptin were measured at baseline and the end of study. Anthropometric indices,     blood pressure levels, food records were assessed before study and by 3-wk intervals until     the end of trail   "
6774|NCT03197207|"     The plan  Quantitative analysis of different acupuncture needle manipulation to treat     chronic shoulder pain includes an objective observation of acupuncture operation (movement     in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions.     Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical     rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking     medicine or Western medicine were included. Then use of distal acupoints GB34 and GB39,     giving once acupuncture manipulation therapy.   "
6775|NCT03197194|"     The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours     improve visual deficit due to acute CRAO with a good safety profile.   "
6776|NCT03197181|"     Motivation represents a core aspect of goal-directed behavior as it determines how much     effort individuals are willing to invest to reach their goals. While research on effort-based     decision-making focuses mainly on effort preferences in younger adults, loss of motivation     might be a key component of the apathetic tendencies frequently seen in older adults.     However, an open question refers to which brain mechanisms underlie motivational processes in     older adults. The investigators have recently shown that the frontopolar cortex plays a     crucial in motivating the exertion of rewarded effort in younger adults. The goal of the     current study is to determine whether frontopolar cortex plays a crucial role for motivation     also in older adults and may thus be a promising target for improving the motivation deficits     in healthy aging. Participants perform computer-based experimental tasks measuring the     propensity to exert cognitive or physical effort for monetary rewards. During task     performance, participants receive anodal or sham transcranial direct current stimulation     (tDCS) over their frontopolar cortex. The study tests whether tDCS over frontopolar cortex     allows modulating participants' motivation to engage in rewarded effort.   "
6777|NCT03197168|"     The principal objective of this pilot trial is to evaluate the effectiveness of a     psychosocial intervention to reduce self-stigma and improve treatment adherence and quality     of life among people with a severe mental illness who attend to Community Mental Health     Centers in Chile. The intervention is based on recovery and narrative therapy and considers     10 group sessions, mainly with patients, but also integrating relatives and professionals in     some of the activities.   "
6778|NCT03197155|"     Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C     virus (HCV) with high-sustained virological response (SVR) rates and very few side effects     has drastically changed the management of HCV infection. The impact of DAA exposure on     hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced     fibrosis remains to be clarified.      Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission,     subsequently treated or not with a DAA combination, were included. Clinical, biological, and     virological data were collected at first HCC diagnosis, at remission and during the     surveillance period.   "
6779|NCT03197142|"     The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the     Province of Pavia with a follow-up up to five years after the event.   "
6780|NCT03197129|"     The amount of time the patient has spent awaiting treatment and the nature of the waiting     room environment influence the anxiety level prior treatment. The objective of the present     study is to compare the effect of waiting room's environment on the levels of anxiety     experienced by children, in sensory adapted dental environment (SADE) and traditional waiting     rooms.Cross-over randomized trial. The participants will be randomly assigned to one type of     waiting room for the first visit, and the other type for the second visit. The participants     will be asked to answer VPT scale while waiting in the waiting room just before entering the     clinic.   "
6781|NCT03197116|"     This is a randomized controlled study to compare the effectiveness of interactive telephone     reminders by a layperson on enhancing compliance with CRC screening by FOBT, when compared     with usual care (i.e. no intervention).   "
6782|NCT03197103|"     The aim of this study is to assess the effect of new tumescent solution for liposuction     containing N-Acetylcysteine (Pietruski solution) on the autologous fat graft volumetric     retention used for healthy women breast asymmetry correction by means of lipofilling.   "
6794|NCT03196947|"     Multicentre, open label, uncontrolled, phase I pharmacokinetic study, to determine the     Maximum Tolerated Dose (MTD) of APO010 administered intravenously on D1, D8 and D15 followed     by a one-week drug rest, in patients with multiple myeloma for who have relapsed or are     refractory to 2 (in high-risk patients 1) or more different prior therapies and who have Drug     Response Predictor (DRP) for APO010 indicating a higher likelihood for response to APO010.     The study will contain an extension phase where the recommended Dose will be tested on     additional patients.   "
6795|NCT03196934|"     To allow subjects who have completed Insys 030 extension study to continue to take     Cannabidiol oral solution.   "
6783|NCT03197090|"     This is a single center, open label, randomized control trial to assess the efficacy of a     one-lead ECG handheld device (Zenicor) for the detection of previously unknown atrial     fibrillation (AF) in hospitalized patients.      All patients admitted to the internal medicine department of the Hospital Fribourg throughout     the study period will be screened for study enrollment. Patients with known or previously     documented atrial fibrillation, patients with a cardiac pacemaker, and implantable     cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the     present trial. The study population will consist of approximately 800 patients in each group     at the University of Fribourg Medical Center. Patients must meet all eligibility criteria for     inclusion into the study.      Patients allocated to the treatment group will undergo twice daily monitoring with the     handheld Zenicor ECG. Additional recordings will be obtained whenever patients notice     palpitations. Recordings will be obtained in the presence of specially trained nurses. The     recordings will then be validated through a web-based interface offered by Zenicor. The     one-lead ECGs will be reviewed by the investigating physicians through the Web-based analysis     service (Zenicor-ECG Doctor System) to assess the presence of atrial fibrillation.      The primary end point of the study is the percentage of newly detected atrial fibrillation at     6 months   "
6784|NCT03197077|"     The study will focus on important aspects related to follicle recruitment using exogenous     gonadotropins in patients with polycystic ovaries:        1. Early follicle recruitment in patients with polycystic ovaries using corifollitropin          alfa: does administration of this drug result in earlier and higher FSH (follicle          stimulating hormone) concentrations above the threshold for follicle recruitment in an          IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in          comparison to normal daily administration of rFSH (recombinant follicle stimulating          hormone, Puregon)?;        2. The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media          registered for clinical use: does stimulation with corifollitropin alfa versus          recombinant FSH have an impact on the maturation rate and developmental capacity of the          oocytes ?   "
13758|NCT03105362|"     This study will assess the tolerability and palatability of an amino acid based oral     rehydration solution (enterade®) compared to current oral rehydration solution among children     with short bowel syndrome .   "
6785|NCT03197064|"     The purpose of this study is to determine if intravenous fosaprepitant can interfere with     nervous system monitoring signals in patients having surgery under general anesthesia. This     medication has numerous effects on the sensory nerve transmission which can theoretically     have effects on the ability to accurately measure somatosensory evoked potentials.   "
6786|NCT03197051|"     Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in     regulation of inflammatory responses, vascular permeability, blood coagulation. It can be     easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly,     the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases     such as diabetes mellitus, atherosclerosis, malignancy has been researched.      In cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion,     oxidative stress which can damage endothelial glycocalyx. In this research, the investigators     would like to discover the impact of perioperative shedding of the endothelial glycocalyx on     the incidence of postoperative acute kidney injury in patients undergoing valvular heart     surgery.   "
6787|NCT03197038|"     Chronic kidney disease (CKD), affects over 45% of all individuals over 70 years of age.     Patients with moderate CKD have more than a two-fold increased risk of cognitive impairment     than those without CKD; furthermore, as many as 20-70% of patients with CKD have established     cognitive impairment and overt dementia. The burden of cognitive impairment and dementia     leads to functional decline and accelerated loss of independence, contributing to the     tremendous individual, societal, and economic burden of CKD (i.e., 20% of Medicare     expenditures in adults >65 years of age). There is no recommended treatment to prevent     cognitive decline in CKD patients, and the few medications available for cognitive impairment     have only short term modest effects. There is a critical need to evaluate therapies to     forestall cognitive impairment, and maintain or improve cognitive functioning in older     patients with CKD. To address this need, this study will test the hypothesis that older     patients with moderate/severe CKD and pre-clinical cognitive impairment randomized to a     6-month home-based exercise program will improve cognitive function and MRI measured brain     structure, compared to a usual care control group. This study will combine an assessment of     cognition with MR imaging techniques to fully evaluate brain structure, blood flow, and     behavior relationships at a level previously not conducted in this population   "
6789|NCT03197012|"     This is a prospective, pilot, single center, open-label study in patients with metastatic     neuroendocrine tumor. Eligible participants will undergo baseline assessments at enrollment.     Study participants will receive a one-time administration of 90Y-DOTA-TOC via the hepatic     artery.      Participants in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the     90Y-DOTA-TOC dose, and undergo additional imaging and assessment.   "
6790|NCT03196999|"     The investigators have developed a mobile app called Resolving Psychological Stress (REPS) to     help alleviate symptoms of PTSD. The app will administer threat-related attention bias     modification to individuals who score high on a PTSD checklist. This study will be     administered remotely to individuals in the United States. The aims of the study are to     explore both the feasibility and acceptability of the app with it's users, as well as,     explore the efficacy of the app at alleviating PTSD severity.   "
6791|NCT03196986|"     This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy     and safety of MIL60 with bevacizumab as first-line treatment when combined with standard     chemotherapy (paclitaxel/carboplatin) in chemotherapy-naive patients with metastatic or     recurrent non-squamous NSCLC.   "
6792|NCT03196973|"     The purpose of this study is to determine if a combination of an antibiotic plus a     corticosteroid is safe and effective in treating AOE   "
6793|NCT03196960|"     The primary aim of this study is to assess if the mobility dose that patients receive in the     surgical intensive care unit (SICU) predicts adverse discharge disposition (primary     endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).   "
6796|NCT03196921|"     This will be an open label phase I/II prospective cohort study to determine the efficacy and     safety of CAMB for the treatment and prevention of cryptococcal infection.   "
6798|NCT03196895|"     Conventional lifestyle modification in the management of type 2 diabetes focuses on weight     loss, through caloric restriction and exercise, to reduce insulin resistance. This approach     is limited because some people either do not need to lose weight, do not want to lose weight,     cannot lose weight, or cannot maintain weight loss over a lifetime. This study proposes to     evaluate the effectiveness of a lifestyle modification that focuses on reducing post-meal     blood glucose (BG) elevations instead of weight loss. It works by teaching participants to:     1) choose low glycemic load foods that do not significantly increase their blood glucose, and     2) increase their routine physical activity after meals when it can offset post-meal blood     glucose elevations. The study will also evaluate the role feedback about blood glucose     fluctuations can play in improving the effectiveness of this program.   "
6799|NCT03196882|"     Currently, there is no consensus regarding iron supplementation dose that is most beneficial     for maternal and offspring health during gestation. This deficit, or excess, of iron     prejudices the mother-child wellbeing. Therefore the hypotheses are that an iron     supplementation adapted to values of hemoglobin at the start of the pregnancy will would be     more effective in preventing iron deficiency, without increasing the risk of     hemoconcentration by the end of pregnancy. This would be helped optimize mother-child health     status.      The aims of the study are to determine the highest level of effectiveness of iron     supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum     for mother-child health.      To accomplish this objective a Randomized Clinical Trial (RCT) triple-blinded was designed.     The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of     gestation.      Stratum 1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement     of 40 or 80 mg/d.      Stratum 2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or     20 mg/d.      This study will be conducted in non-anemic pregnant women at early gestation stage, and their     subsequent newborns. The data recollected to mothers will be: socio-economic data, clinical     history, food item frequency, lifestyle and emotional state, and adherence to iron supplement     prescription. In addition, biochemical measured will be Hemoglobin, serum ferritin, C     reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children, the     data collected will be: ultrasound fetal biometry, anthropometric measurements, and     temperament development      Should conclusive outcomes be reached, the study would indicate the optimal iron     supplementation dose required to promote maternal and infant health. These results would     contribute towards developing guidelines for good clinical practice.   "
6800|NCT03196869|"     This study is to observe and compare the effect of docetaxel plus lobaplatin induction     chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy     combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of     locally advanced head and neck squamous cell carcinoma.   "
6801|NCT03196856|"     This study will analyze the effects of Greek yogurt consumption and an 8 week exercise     intervention on muscle size, body composition and bone health in untrained, university-aged     males.   "
6802|NCT03196843|"     The purpose of this study is to evaluate the efficacy of radiotherapy combine with     raltitrexed in older patients with head and neck squamous cell carcinoma.   "
6803|NCT03196830|"     This study is a single arm study to investigate the efficacy and safety of CAR-T targeted     CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients     will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for     at least 2 years.   "
6804|NCT03196817|"     Carpal tunnel syndrome (CTS) is the most common neuropathic compression syndrome of the upper     limbs, caused by compression of the median nerve in the wrist. There is no gold standard for     establishing the diagnosis of STC. The diagnosis can be based on clinical findings and     electrodiagnostic tests. Treatment options can be divided into surgical and non-surgical     procedures. Surgical interventions include open carpal tunnel release, mini incision or     release of the endoscopic carpal tunnel. Nonsurgical include daily activities modification,     oral anti-inflammatory drugs (NSAIDs), oral corticosteroids, splints, corticosteroid     injections or other options (laser therapy, ultrasound or acupuncture)      The aim of this study is to compare randomly, conservative treatment for CTS with night     splint of the wrist versus local infiltration of corticosteroids after a min-imum period of     six months follow-up.      Patients will be divided into two groups: night orthesis group that will receive the     prescription to purchase the orthesis and guide the use of it; and infiltration group of     patients will be referred to the Moema Alvorada Hospital to carry out infiltration. These     patients will be evaluated before application, one week, one month, three months and six     months after intervention.   "
6805|NCT03196804|"     To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple     iv injection in healthy male subjects.   "
6806|NCT03196791|"     This study is designed to evaluate the impact of muscle relaxation during laparoscopic     gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary     endpoint is number of harvested lymph node that is critical point regarding quality of     surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding,     surgeons' satisfaction.      The patients were randomly assigned to two groups using a computer-generated randomization     table : 196 persons        -  Deep neuromuscular block group (98persons)        -  Moderate neuromuscular group (98persons)   "
6807|NCT03196778|"     Older studies in animals and humans have shown cancer responses to very low doses of     whole-body or hemi-body radiation. To study the effects of low doses of radiation in patients     with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions     of low dose radiation, delivered over 5 weeks. Participants will be followed on study for 12     months, capturing PSA, CBC, QoL and blood samples for immunological analysis.   "
6809|NCT03196752|"     The cricothyroid membrane is the most common position that the invasive airway secure is     performed, but it is not easy to identify the cricothyroid membrane by tactile perception.     Although it is recommended to use the laryngeal handshake method for identifying the     cricothyroid membrane in difficult airway society 2015 guidelines for management of     unanticipated difficult intubation in adults, there is only suggestion without clinical data     about how much the laryngeal handshake method improves the accuracy of identification of the     cricothyroid membrane So we made the hypothesis that the cricothyroid membrane is identified     more correctly when the laryngeal handshake method is used than when that method is not used.     And we try to find out whether there is actual difference about identification of the     cricothyroid membrane between using the laryngeal handshake method and not using that method.     By identifying the difference between them, we are going to support the recommendation of     guidelines and make the evidence for educating the doctors who have any possibility to     perform the criocthyroidotomy to use the laryngeal handshake method skillfully in the 'cannot     intubate, cannot oxygenate' situation.   "
29215|NCT02903238|"     This is a two week,single-blind study evaluating pain response and changes in brain imaging     upon treatment with placebo in people with knee OA.   "
6810|NCT03196739|"     Because virtual reality can provide more enriched environment, repetitive goal-oriented     tasks, and increased patients' interest and motivation, it is expected to stimulate     neuroplasticity of injured brain and promote recovery in patients with brain disorders. On     the other hand, immersive virtual reality using a head-mounted display has not yet been     attempted in the rehabilitation of patients with brain disorders. In addition to the benefits     of existing virtual reality or game rehabilitation, immersive virtual reality can further     enhance brain plasticity, such as the effect of mirror therapy or action observation, through     self-awareness of the body in the virtual space. The purpose of this study is to investigate     the feasibility of applying the immersive virtual reality using a head-mounted display in     patients with upper extremity dysfunction due to brain disorders.   "
6811|NCT03196726|"     Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at     primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to     management by Medical Officer as compared to Medical Officer alone   "
6812|NCT03196713|"     The objective of this study is to examine the significance of knowledge of autism spectrum     disorder (ASD), and early intensive behavioral intervention, as well as trust in EIBI,     adequate assessment of EIBI quality, and EIBI supervision on EIBI intervention outcome in     ASD.   "
6813|NCT03196700|"     The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short     course radiation treatment in patients with symptomatic advanced head and neck cancer.   "
6814|NCT03196687|"     Patients with type 2 DM may develop a cardiomyopathy often called diabetic cardiomyopathy     which is characterized by left ventricular diastolic dysfunction in early stages      Type 2 DM is associated with various types of subclinical target organ damage resulting in     elevated risk of CVD events, moreover there is growing evidence that a prediabetic status,     such as impaired fasting glucose is also related to subclinical target organ damage when     compared to a group with normal glucose metabolism Diabetes mellitus is a well-studied major     risk factor for coronary heart diseases, which is one of the leading causes of death     worldwide. Another distinct entity of diabetes-related cardiac affection is the diabetic     cardiomyopathy. This entity of cardic affection by diabetes still needs more and more     attention, not only because it is common in diabetic patients, but also because of its easy     detection by the simple, inexpensive and widely available diagnostic echocardiography.   "
6815|NCT03196674|"     This study will compare the effect of manipulated vs. non-manipulated feedback during the     rehabilitation of individuals with disability due to stiff shoulder following multiple     trauma. This will be accomplished using the state-of-the-art real-time motion capture     technology.   "
6816|NCT03196661|"     Adopt the design of random, blind method and placebo to parallel control and progressive     methods of groups to study and evaluate the safety and immunogenicity of influenza A (H7N9)     vaccine (two types, one type with two specifications) on people of different ages. The     vaccines used for testing include: influenza A (H7N9) virus inactivated vaccine/split     influenza vaccine (15μg /dose), influenza A (H7N9) virus inactivated vaccine/split influenza     vaccine (30μg / dose), influenza A (H7N9) virus inactivated vaccine/whole influenza vaccine     (7.5μg / dose) and influenza A (H7N9) virus inactivated vaccine/ whole influenza vaccine     (15μg / dose).      The study between different subgroups was carried out in an orderly and progressive manner,     that is, each kind of vaccine by the dose is from low to high according to the order of age     from old to young. Firstly, the study on 15μg/dose split vaccine group (aged 18 and above)     and 7.5μg/dose whole-virus vaccine group (aged 18 and above) was carried out and then the     study on 15μg/dose split vaccine group (aged 12-17) and 7.5μg/dose whole-virus vaccine group     (aged 12-17) was conducted upon 7-day safety was confirmed after the vaccination, finally the     study on 30μg/dose split vaccine group (aged 18 and above) and 15μg/dose whole-virus vaccine     group (aged 18 and above) was done. By that analogy for the same conditions, the next group     of test can be done after the 7-day safety of the last group of vaccine is confirmed.      Subjects and researchers didn't know the formulations of the vaccines used. The vaccine is     injected into the upper arm deltoid muscle. After 30 minutes of field observation on safety,     the subjects' axillary temperature shall be recorded on the Record Book prepared by the     research and local and systemic reactions to injection at the 6th, 24th, 48th, and 72th hour     and on the 4th, 8th, 21st and 30th day shall also be recorded. This paper collected 5 serum     samples: day 0 (before the first-dose vaccination), day 4 (after the first-dose vaccination),     day 21 (before the second-dose vaccination), day 25 (fourth day after the second-dose     vaccination) and day 42 (21st day after the second-dose vaccination), of which, blood samples     on day 0, 21 and 42 should be stored at 18℃ for antibody detection and the remaining 2 blood     samples are only used for blood routine examination, routine urine test, blood biochemistry     and other laboratory examinations.   "
6817|NCT03196648|"     The purpose of this study is to evaluate the safety and efficacy of a newly formulated     foaming gel product on gingivitis and/or moderate periodontitis when used with or without the     GLO Science accelerating device (GLO Device), compared to standard tooth brushing with     antioxidant whitening toothpaste with or without flossing (split mouth design for control     group).      This is a 60-day randomized single blinded parallel group study. After 42 days, all use of     interventional products were discontinued, and the participants returned to the clinical     center at day 60 for final measurements. The primary outcomes assessed in this study were the     differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 & 60     days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque     amount.      It is hypothesized that participants using the gingival health product with the GLO Device     will experience greater reductions in GI & BOP measurements than the control group, as well     as participants using the gingival health product on a toothbrush alone.   "
6818|NCT03195595|"     This is retrospective study that will be done in Cardiothoracic surgery department in Assuit     university hospitals for one year duration aiming to compare minimal invasive technique to     conventional median sternotomy for mitral valve surgery regarding early postoperative     outcomes and pain   "
6819|NCT03195582|"     The aim of this study is to evaluate the healing of peri-implat tissue following surgical     uncovering with the adjunctive use of Chlorohexidine (CHX) gel.   "
6820|NCT03195569|"     To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the     study of QL1101 and Avastin® in patients with Non-squamous Non-small Cell Lung Cancer   "
6821|NCT03195556|"     Our laboratory has discovered that ultrasound (US) imaging together with clinically approved     microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations     have been made in mice with and without peripheral artery disease (PAD), and also in humans     where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was     found also to augment perfusion by almost 2-fold. The latter human studies were performed     with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In     this study, we will measure the degree to which limb perfusion is augmented with specific     therapeutic CEU settings that are still within the FDA-approved limits with regards to US     power and contrast dosing.   "
6972|NCT03194620|"     The objectives of this study are to i) describe the absorption, distribution, metabolism and     excretion (ADME) and pharmacokinetic parameters of selected dietary (poly)phenols in humans;     and ii) to compare the ADME and pharmacokinetic parameters of selected dietary (poly)phenols     in humans.   "
6822|NCT03195543|"     The objective of the present study is to assess blood coagulation disorders in patients with     Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. The     investigators aim to evaluate any possible coagulation abnormalities related to the patients'     primary disease and any possible effects the pulmonary hypertension- specific therapy may     have on hemostasis.   "
6823|NCT03195530|"     A correlation between the bispectral index values and electroencephalographic patterns at the     loss of consciousness (LOC) when using propofol in elderly patients, has not been determined.      Our aim is to describe the BIS values and the power of the alpha band in the     electroencephalography in elderly patients, at the LOC moment.   "
6824|NCT03195517|"     The aim of our research was to define both in vivo and in vitro whether and to what extent an     high-impact exercise program would affect bone cell turnover and improve the QoL in     osteopenic postmenopausal women.   "
6825|NCT03196622|"     Identify the threshold which the handgrip strenght can be used as a screening test of     sarcopenia.      Handgrip strenght can be used in daily clinical practice to screen patients having sarcopenia     to improve treatment and quality of life.   "
6827|NCT03196596|"     Transcatheter aortic valve implantation is increasingly used to treat patients with severe     aortic stenosis who are at increased risk for surgical aortic valve replacement and is     projected to be the preferred treatment modality. As patient selection and operator     experience have improved, it is hypothesised that device-host interactions will play a more     dominant role in outcome. This, in combination with the increasing number of valve types and     sizes, confronts the physician with the dilemma to choose the valve that best fits the     individual patient. This necessitates the availability of pre-procedural computer simulation     that is based upon the integration of the patient-specific anatomy, the physical and     (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro     experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing     the valve size that best fits the individual patient.      The aim of this study is to assess the added value of patient-specific computer simulation in     valve size selection.   "
6828|NCT03196583|"     Oral appliances (OA) have emerged as an alternative to continuous positive airway pressure     (CPAP) for obstructive sleep apnea (OSA) treatment. The most commonly used OA reduces upper     airway collapse by advancing the mandible (mandibular advancement devices, MAD).      There is a strong evidence base demonstrating that MADs improve OSA in the majority of     patients, including some with more severe disease. However, MADs are not efficacious for all,     with approximately one-third of patients experiencing no therapeutic benefit. Patients often     prefer MADs to gold-standard CPAP treatment. Head-to-head trials confirm CPAP is superior in     reducing OSA parameters on polysomnography; however, this greater efficacy does not     necessarily translate into better health outcomes in clinical practice. Comparable     effectiveness of MADs and CPAP has been attributed to higher reported nightly use of MADs,     suggesting that inferiority in reducing apnoeic events may be counteracted by greater     treatment adherence.      The MAD in study, called Bite-Velo Linguale (BVL), features a novel monobloc device including     a tongue retainer, a suction cavity that maintains the tongue down onto the mouth floor in     order to prevent it from raising towards the hard palate, and therefore increasing the retro     lingual aerial space. Its design requires the presence of only four occlusal points, allowing     for a direct anchorage onto the mandibular bone, thus reducing the risk for occlusal changes,     tooth loosening and the development of an anterior cross bite, which represent some of the     major long-term adverse effects of oral appliances.      MADs are generally well tolerated, although short-term adverse effects during acclimatization     are common. Long-term dental changes do occur, but these are for the most part subclinical     and do not preclude continued use. The BVL in study features technological advances aimed at     preventing long-term dental changes, as well as improving tolerability and easiness of use.   "
6829|NCT03196570|"     The purpose of this study is to determine the feasibility and preliminary efficacy of a web     and text-messaged based intervention designed to increase physical activity among Latino men     in Rhode Island. The study will also examine potential moderators of treatment effects     including demographics, acculturation, and environmental variables such as the neighborhood     built, social and economic environments.   "
6830|NCT03196557|"     The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male     subjects   "
6844|NCT03196375|"     The COMMEND Study will assess the safety and effectiveness of FLX-787 in men and women with     Motor Neuron Disease [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral     Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)] experiencing muscle cramps.     Participants will be asked to take two study products during the course of the study. One of     these study products will be a placebo.      Approximately 120 participants in approximately 30 study centers across the United States are     expected to take part. Participants will be in the study for approximately 3 months and visit     the study clinic 3 times.   "
6868|NCT03196063|"     Patellar tendinopathy is characterized by anterior pain in the knee, due to the great demand     imposed on the extensor mechanism of the knee. Evidence shows that the most appropriate     treatment for this condition is the conservative treatment, through strengthening with     eccentric exercises. However, a recent editorial proposes a new treatment protocol based on     concentric and eccentric exercises, with the initial prescription of isometric exercises. The     hypothesis of this study is that the protocol is as good as the eccentric exercises,     generating less pain.   "
13759|NCT03105349|"     This is a phase 4 clinical trial to treat patients who have failed to treat with regimen     based on an inhibitor of the NS5A   "
6845|NCT03196362|"     Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with newly     diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to     investigate whether sequential treatments using fixed dose combination of     pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical outcomes inpatients with     newly diagnosed type 2 diabetes.      We plan to include 50 patients with newly diagnosed type 2 diabetes who are drug naïve and     meet the inclusive criteria will be enrolled. After baseline assessments, SIIT will be     applied to all patients using insulin pump to achieve and maintain euglycemia for 2 weeks.     After completion of intensive treatment, insulin pump will be stopped. Patients were randomly     assigned into either of the following two groups: PIO/MET group: pioglitazone/metformin     (15mg/500mg) will be orally administrated twice daily to the subjects for 12 weeks; placebo     group: placebo is given twice daily to all subjects for 12 weeks. Afterwards, patients will     be followed up for 48 weeks. Primary endpoint is difference in remission rate at the end of     study. Secondary endpoints include proportion of patients who achieve glycosylated hemoglobin     A1C <7% at the end of study; differences in β-cell function , insulin sensitivity and     incidence of adverse events among treatment groups.   "
6831|NCT03196544|"     The overall goal of this project is to develop a novel transdiagnostic behavioral treatment     -- social approach training -- intended to enhance positive social connections in individuals     with elevated anxiety and/or depression. Social relationship impairments are pervasive and     debilitating consequences of anxiety and depression. Existing treatments have some beneficial     impact on social functioning; however, many people continue to have few and/or poor quality     relationships following treatment, even after experiencing symptom relief. This study will     evaluate the effects of social approach training on the brain systems that have been shown to     be important for establishing positive connections with others. Approximately 60 individuals     (ages 18-55) seeking treatment for anxiety or depression will participate in this study.     Participants will be randomly assigned with equal probability to one of two versions of     social approach training (5 or 10 sessions) or a waitlist (assessment only) control group.     Participants will be assessed at baseline and post-treatment and compared on measures     assessing brain responses to social reward (primary outcome), as well as physiological,     behavioral, and emotional responses to social reward (secondary outcomes). It is hypothesized     that participants assigned to social approach training will display greater increases from     pre- to post-treatment in activity in brain systems that regulate the processing of social     reward (e.g., striatum) relative to participants in the control group. This study will also     determine whether the 5- vs. 10-session versions of the treatment program result in     meaningful differences, compared to each other, in how the brain responds to social reward.   "
6832|NCT03196531|"     The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared     with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under     fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.   "
6833|NCT03196518|"     The goal of the study is to evaluate a new imaging test that may allows the investigators to     predict the uptake of radioactive iodine by thyroid cancer faster than the current standard     and that does not interfere with the uptake of radioactive iodine used for therapy.   "
6834|NCT03196505|"     This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine     (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing     total IV and oral morphine equivalents required after laparoscopic bariatric surgery.     Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the     course of three days. Having a long acting local anesthetic should provide better pain     control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the     use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery.     This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can     potentially improve patient post-operative pain control, decrease narcotic use, decrease     hospital length of stay and readmission rates and improve patient satisfaction after     bariatric surgery.   "
6835|NCT03196492|"     The investigators are doing a study on the bacteria that normally live in the vagina and what     effect, if any, Depo-Provera has on the bacteria.      Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or     sexually transmitted disease (STD) check-up, or have a child and are planning to receive a     Depo-Provera shot for contraception or have declined the use of hormonal contraception may     join.   "
6836|NCT03196479|"     This study aimed to compare the efficacy of ketamine and propofol mixture with 1:6 ratio and     1:4 ratio for endoscopic retrograde procedure   "
6837|NCT03196466|"     The purpose of this study is to develop population pharmacokinetic models for antiepileptic     drugs in a pediatric population.      The interest of these models is multiple:        -  describe the pharmacokinetics of these molecules in children and explain the          inter-individual variability of concentrations through covariates such as weight, age,          co-treatments and renal function;        -  estimate maximum, minimum and exposure concentrations from the individual          pharmacokinetic parameters for each patient;        -  propose adaptations of doses for certain classes of children (according to age, weight          etc.) and individualize the doses.   "
6838|NCT03196453|"     Children with abnormal weight development of BMI will be given either placebo or a probiotic     protein formula and measures of weigh gain during a 3-mont treatment will be conducted   "
6839|NCT03196440|"     The purpose of this study is to identify the thresholds sensitivity of the five basic tastes     in an elderly population and relate to food intake, nutritional status, age, gender and     others variables.   "
6840|NCT03196427|"     The purpose of this study is to determine vedolizumab IV safety profile, the effect of     long-term treatment on time to major inflammatory bowel disease (IBD)-related events     (hospitalizations, surgeries, and procedures), to examine the effect on health-related     quality-of- life measurements and to determine the effect on patterns of growth and     development in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD).   "
6841|NCT03196414|"     To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen T     cells in treating patients with CD138 or BCMA positive multiple myeloma that is refractory to     further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).   "
6842|NCT03196401|"     This study is being done to evaluate whether the combination of immune therapy and radiation     therapy to plasmacytoma that can stimulate the immune system to attack and eliminate the     abnormal cells in the bone marrow and perhaps delay or prevent the cancer from worsening.     This study will evaluate whether the immune system responds to the combination of radiation     with immunotherapy. It is possible that that the combination of immune therapy and radiation     may not make any difference in whether or not the patient will develop multiple myeloma in     the future.   "
6843|NCT03196388|"     This research study is evaluating a drug called enzalutamide in combination with external     beam radiation therapy as a possible treatment for prostate cancer. Presently, when     participants receive hormonal therapy with radiation therapy for prostate cancer, medications     are given to reduce testosterone levels in the blood stream. This leads to side effects such     as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose     of this study is test another form of hormonal therapy with radiationtherapy. The medication     called enzalutamide will be used with radiation therapy. Instead of lowering testosterone,     enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used     with radiation will lower the PSA without causing the side effects associated with     medications that lower testosterone in the blood stream   "
6847|NCT03196336|"     Hypothesis: Pharmacotherapy follow-up can improve clinical outcomes of outpatients with type     2 diabetes mellitus.      Methods: In this single blind, placebo-controlled trial, the participants with type 2     diabetes mellitus are randomized into two groups:        1. pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and        2. control (n=30, attended by the usual procedure of dispensing).      Primary outcomes evaluated are: hospitalization (percentage of participants hospitalized),     severe evolving complication - ischemic or proliferative retinopathy, severe renal     insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion (presence or     absence).      Other parameter checked: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP),     total cholesterol (TC), waist circumference (WC), body mass index (BMI) and mortality. The     investigators follow up all patients for up to 12 months.   "
6848|NCT03196323|"     The overall purpose of this study is to develop a broad-based (i.e., multiple domains)     behavioral outcome measure for children between the ages of 3-18 years with Rett syndrome     (RTT). The innovative approach of this proposal consists of integrating the process of     developing a behavioral questionnaire to an ongoing large-scale data collection project. The     Natural History Study of Rett Syndrome and Related Disorders (RTT5211) is a project that     collects data on diverse aspects of the clinical evolution of individuals with RTT and     related disorders. This project will serve as the basis for recruitment of subjects and it     will also provide key demographic and clinical data for cohort characterization and for     determining clinical relevance of the instrument (RettBe). An initial 100-subject cohort will     allow for the testing with one rater of RettBe 1.0, a 50-item questionnaire formed from     existing measures, a panel of clinicians and behavioral experts in RTT, and a focus group of     parents and caregivers of children with RTT. Scores on RettBe 1.0 will be statistically     analyzed to determine their psychometric properties, including its content validity. Items     that do not meet psychometric standards (e.g., ceiling effect) will be eliminated.      Additional items will be added if the parental survey attached to RettBe 1.0 or clinician     input suggests so. The resulting modified assessment, called RettBe 2.0, will be administered     to a larger (validation) cohort of 300 participants. RettBe 2.0 will also be subjected to     analysis of psychometric properties. RettBe 2.0 will also be administered to two raters per     subject, in order to determine inter-rater reliability. In addition, these raters will be     completing other behavioral and clinical measures for further evaluating the validity of     RettBe 2.0 as well as for determining its clinical and functional significance. Finally, the     investigators will obtain input from a panel of clinicians (site PIs and their designated     clinicians) about content validity and clinical impact. The resulting version will be     released as RettBe 3.0.   "
6849|NCT03196310|"     Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection     for basal joint arthritis.   "
6850|NCT03196297|"     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of     the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under     the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A     without inhibitors.   "
6851|NCT03196284|"     This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to     assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once     daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.   "
6852|NCT03196271|"     An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally     complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years,     adolescents and adults with intractable epilepsy or other disorders where the KD is     indicated.   "
6853|NCT03196258|"     Psychological factors such as stress, distress, anxiety, depression, and poor coping     strategies may be associated with ongoing pain following injuries such as fractures. In order     to study this relationship, researchers at McMaster University have developed the Somatic     Pre-Occupation and Coping (SPOC) questionnaire, which identifies illness beliefs that may     help to predict which patients are at risk for ongoing pain, reduced quality of life, and     delays in returning to work and leisure activities after a fracture requiring surgical     treatment. Previous research using the SPOC questionnaire suggests the possibility that     fracture patients with illness beliefs that put them at risk for developing ongoing pain     could be identified early in the treatment process. These patients may benefit from cognitive     behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing     ongoing pain and improving quality of life. The goal of this study is to determine if CBT is     effective in reducing ongoing pain and improving quality of life in fracture patients who     show illness beliefs that may place them at risk for developing ongoing pain.   "
6854|NCT03196245|"     Pregnant women have increased morbidity and mortality due to infection with influenza.     Changes in T cell function have been proposed as possible mechanisms for this finding. We     believe that pregnancy induced changes in NK cell phenotype and function also impact     influenza immunity. This study will compare the immune response of pregnant women and     controls to TIV influenza vaccination as a surrogate for infection. In addition pregnant     women with flu like illness will be enrolled to evaluate changes in immune response following     influenza infection as compared to vaccination.   "
6855|NCT03196232|"     This phase II trial studies how well epacadostat and pembrolizumab work in treating patients     with gastroesophageal junction or gastric cancer that has spread to other parts of the body     and cannot be removed by surgery. Epacadostat may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may     block tumor growth in different ways by targeting certain cells. Giving epacadostat and     pembrolizumab may work better in treating patients with gastroesophageal junction or gastric     cancer.   "
6869|NCT03196050|"     Cancer is becoming a chronic disease, with the requirement of a lifelong intake of     cancer-controlling drugs. While young(er) patients may cope with this, geriatric cancer     patients may require a more customized and tailored follow up.      Most elderly patients have multiple other diseases (comorbidities) and, due to many other     factors, may per se not tolerate or simply not follow anticancer therapies. This may not only     impair quality of life (QoL), but on the long rung also the therapeutic outcome (survival).      Handheld devices provide a new reporting/communication tool for patients and health care     providers. TeleGraPH will assess if these devices are a suitable communication modality in a     cohort of geriatric cancer patients.   "
6904|NCT03195504|"     Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend     time before a decrease in the level of oxygen in the blood occurs. During this period, obese     patients have a faster decrease in the level of oxygen in their blood. This study uses a     device called high-flow nasal cannula (HFNC), which delivers humidified high-flow oxygen     through 2 small plastic tubes placed just inside nostrils. In the intensive care unit     settings this device has been used extensively and has become a standard practice. Purpose of     this study is to determine whether these high-flow nasal cannula increase the time safely     when going to sleep during elective surgery.   "
6856|NCT03196219|"     An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and     tolerability of multiple C16G2 Varnish and Strip applications in male and female dental     subjects 12-75 years of age. The study will compare multiple study drug administrations of     C16G2 Varnish and/or C16G2 Strip in three study arms.      In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a     daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip     administered over 7 days. Following the three C16G2 Varnish applications, each subject will     receive 7 days of AM and PM dosing with C16G2 Strip and will be followed for microbiology for     up to 2 months after the last study drug administration.      Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four     C16G2 Varnish or Placebo applications over 7 days, followed by 3 additional weekly varnish     administrations. Subjects will be followed for microbiology for up to 2 months after the last     study drug administration.The treatment allocation will be 1:1 (6 subjects receiving C16G2     Varnish, 6 subjects receiving Placebo).      Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to     two week post last study drug administration from Study Arm 2. If initiated, Study Arm 3 will     enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2     Varnish over 10 days, for a total of 10 doses and will be followed for microbiology for up to     2 months after the last study drug administration.   "
6857|NCT03196206|"     Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in     participants with normal renal function and moderate to severe renal impairment.   "
6858|NCT03196193|"     The purpose of this study is to compare reduction positon maintenance rate at 3 weeks     post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2     technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum     15sites, total study duration is 22months.   "
6859|NCT03196180|"     This phase I clinical trial studies the side effects of topical fluorouracil and imiquimod     ointment in treating patients with high-grade cervical intraepithelial neoplasia. Topical     fluorouracil may kill precancerous cells. Imiquimod ointment may stimulate the immune system.     Applying topical fluorouracil and imiquimod ointment may cause fewer side effects and may be     a better way to treat patients with precancerous cervical lesions.   "
6860|NCT03196167|"     The purpose of this study is to demonstrate faster time to extubation after arrival in the     cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery     bypass grafting (CABG) who receive Sugammadex as compared to placebo.   "
6861|NCT03196154|"     Progression of T2DM is widely accepted to be contributed by two main components: beta cell     function deterioration where insulin secretion is impaired and insulin resistance where     insulin physiological response is reduced. Insulin resistance and beta cell function will be     estimated through a mathematical model, homeostasis model assessment. Fasting insulin and     C-peptide will be measured using liquid chromatography tandem mass spectrometry. Insulin     resistance and beta cell function is then compared with the glycaemic control, HbA1C.   "
6862|NCT03196141|"     The purpose of this study is to compare 3 methods of assessing endothelial function in     healthy female volunteers and pregnant women with and without pregnancy induced hypertension.     The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and     Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood     pressure, 10 pregnant with hypertension) will be enrolled.   "
6863|NCT03196128|"     This study will examine whether or not the use of digital communication methods (text     messages and emails) improves patient engagement with Early Intervention Psychosis (EIP)     Services, compared to standard communication methods (letters and telephone calls).      One of the biggest challenges of psychiatric services is patient disengagement. People with     psychosis, are often difficult to engage in community based mental health services (CMHTs).     Patient's who disengage from psychiatric care often have higher social care needs, are often     more unwell and are more likely to be detained under the Mental Health Act compared to those     who engage. It is important to examine the reasons for this for both research and clinical     reasons to establish the effectiveness of the service to its users. Importance must be placed     on the clinician's perspective of the engagement; the patient's perspective is vital.      This study is a pilot two-arm pragmatic Randomised Control Trial to examine the feasibility     of assessing engagement of EIP services through different communication methods. Patients and     care-coordinators will use self-reported scales to measure engagement to determine whether     this improves through the use of different communication methods.      Patients will be asked to consent to being randomly allocated to one of two groups:      (i.) Receive letters, phone calls and voicemail's from their care coordinator for standard     appointments.      OR      (ii.) Receive text messages and emails from their care-coordinator for standard appointments.      Patients eligible for this study will be in their first six months of care under an EIP CMHT     and who have consented to take part. They will be aged 18-35, not a hospital inpatient, have     access to the Internet, a mobile phone and who are fluent in the English language.      Care-coordinators will assess the feasibility and acceptability of the design and procedures     and determine an effective sample size calculation for a future large scale pragmatic     Randomised Controlled Trial.   "
6864|NCT03196115|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Hyaline     fibromatosis syndrome from plasma   "
6865|NCT03196102|"     While the military has taken steps to reduce tobacco use over the past two decades, over a     quarter of new military recruits report regular tobacco use prior to enlistment. This rate is     higher than the national prevalence of 21.3% of US adults. Brief health prevention programs     may be particularly effective for Airmen in Technical Training, given that all Airmen have     been tobacco free for 11 ½ weeks and nearly 2/3rds are confident that they won't return to     tobacco. We have developed and validated a Brief Tobacco Intervention (BTI) that is currently     being implemented as part of Technical Training. We found that a motivational interviewing     based, 40 minute BTI was efficacious in increasing perceived harm and decreasing intentions     to use tobacco in a sample of 1055 Air Force trainees. Although we obtained significant     positive changes in latent cognitive constructs for tobacco behavior that are highly     predictive of future tobacco use in youth and young adults, the Little et al study did not     obtain measures of actual tobacco resumption following the ban on tobacco in Air Force     training. Given that 69.8% of all tobacco resumption/initiation occurs in Technical Training,     a study that evaluates the short-term impact of our BTI on actual tobacco use is necessary     prior to conducting the full scale R01 that would evaluate the long term efficacy of the BTI     intervention. Thus, we propose the following Specific Aims: (1) To recruit approximately     2,000 Air Force trainees at the beginning of Technical Training at Joint Base San     Antonio-Lackland Air Force in San Antonio, Texas during the 11 ½ week involuntary cessation     ban; (2) To randomize participants to either (a) receive our cigarette smoking military     tailored pamphlet (HL095758), The Airmen's Guide to Remaining Tobacco Free (Airmen's Guide;     which has been disseminated and is now the standard of care in the Air Force) or (b) the     Airmen's Guide + Brief Tobacco Intervention (BTI); (3) To determine the short-term (3 month,     end of Technical Training) efficacy of the intervention on tobacco abstinence. Our primary     outcome is tobacco abstinence at the end of Technical Training to determine an estimated     effect size as well as establish the requisite preliminary work for a subsequent R01. Given     that over 220,000 new recruits enter the military annually in one of the service branches,     the public health implications of an effective brief tobacco intervention targeting the most     commonly used tobacco for military personnel in Technical Training is considerable. If the     BTI is proven efficacious it can be easily disseminated to other service branches that have     similar tobacco bans during Technical Training.   "
6866|NCT03196089|"     In a randomized, sham-controlled trial the investigators will test whether supplemental     oxygen given during cardiopulmonary exercise testing will improve exercise performance and     physiological parameters in patients with chronic obstructive pulmonary disease.   "
6870|NCT03196037|"     Purpose:To gather preliminary data and to determine the feasibility and acceptability of an     8-week Tai Chi intervention for adults cancer survivors (survivors) who report experiencing     cognitive impairment, and to perform exploratory analyses to assess improvements in cognitive     performance, health-related quality of life, brain activity, and blood-based biomarkers.      Participants: Adult survivors (> 18 years old) who report experiencing cognitive impairment     and are within 60 months of completion of chemotherapy for treatment of a breast cancer     diagnosis.      Procedures (methods): A single arm pre-/post-test non-randomized study design in adult cancer     survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60     months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and     consist of feasibility, acceptability, expectancy/credibility, health-related quality of     life, cognitive performance, serum biomarkers, and brain activity.   "
6871|NCT03196024|"     The Corazón de la Familia study is a randomized controlled trial to examine the effects of a     novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes     and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health     workers, the family-focused intervention engages two members of a family in an educational     program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles     among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a     randomized controlled trial using a 2-group design and compare the short-term and long-term     impact of the family-focused active intervention to an individual-focused control condition     on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will     examine outcomes of participants in the family-focused intervention to determine how each     family member's engagement in healthy lifestyle behaviors and level of support for the other     family member's engagement in healthy lifestyle behaviors affects their own and their     partner's outcomes.   "
6872|NCT03196011|"     As many as 20% of patients are unhappy with the results of total knee replacement (TKR).     Various changes to surgical technique have tried to address this but have not led to a     significant improvement in the numbers of patients satisfied with their operation.      Recently, attention has focussed on alignment of the leg. When viewed from the front, a     number of people do not start with a straight, mechanically aligned leg. Traditionally, when     implanting a knee replacement, the surgeon tries to put the shin bone half of the knee     replacement perpendicular to the floor to equalise stresses on the in and outside of the     joint. However, this may result in the alignment of the leg changing considerably, straining     the soft tissues around the knee and contributing to dissatisfaction with TKR.      There has been a move by some surgeons to change practice, and to implant the TKR in a way     that replicates the alignment of the patient's own original knee- alternative alignment.     Studies looking at alternative alignment have not shown any loss of satisfaction with results     of TKR and indeed are showing some signs that in the short term, function of the knee may be     better with the new technique.      The research team are planning to run a study comparing the knee replacement used in Exeter-     the Triathlon- when put in place using traditional alignment versus using the alternative     alignment methods. The outcomes will be assessed in various ways including patient     satisfaction questionnaires, measuring muscle strength, flexibility around the knee, and by     assessments of alignment of the new knee on X-rays and Computerised Tomography scans. The     research team will look at short term results for satisfaction and function of the knee, and     in the long term look at wear and survivorship to see if patient satisfaction with TKR can be     improved.   "
6873|NCT03195998|"     The most common and widely accepted method of monitoring bilirubin levels in neonates is the     use of the laboratory analyzation of serum blood levels. Unfortunately this method is     invasive, painful, and can progressively lead to increased blood loss in the neonate. It also     requires the use of additional time and resources to coordinate sending the sample to the     laboratory and processing the specimen in the lab. There exists a different option for     obtaining bilirubin levels in neonates which is the transcutaneous bilirubinometer. This     device detects bilirubin levels at the bedside and has been validated for use in infants born     at > 35 weeks gestation. There are a limited number of studies evaluating its use in     premature infants.      Our aim is to assess the diagnostic accuracy and efficacy of transcutaneous bilirubinometry     (TcB) of the Dräger JM-103 by comparing (TcB) readings to total serum bilirubin (TSB) results     in neonates born at 23 0/7-34 6/7 weeks gestation.   "
6874|NCT03195985|"     The study will focus on measuring stress, rumination and cognitive function across three time     points in old adults with subjective cognitive complaints via a 4-week short mindfulness     intervention, as compare to an active control condition (psycho-education course ge Well).      This is a pilot study.   "
6875|NCT03195972|"     Oral anticancer treatments are increasingly numerous. They represent an additional     alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who     prefer this route of administration over intravenous treatment. The objective of oral     therapies is twofold: to remove the constraints and risks associated with infusions and to     allow the patient to follow his treatment at home.      However, they have significant adverse effects that may affect patients, who are sometimes at     a disadvantage compared to how they are treated, and potentially lead to non-compliance with     the consequences.      This study will identify the factors associated with non-adherence and determine the impact     of this non-adherence in terms of treatment efficacy and tolerance.      The aim of this routine care study is to evaluate the adherence to oral anticancer therapies     during 3 months.   "
7317|NCT03190083|"     The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide     additional information to evaluate the extent of disease and additional findings that would     aid in staging a new breast cancer patient. This would impact surgical planning and improve     patient outcomes.   "
6903|NCT03195608|"     Parkinson's disease (PD) impacts an individual's fitness to drive in a number of ways that     increase the crash risk in this population. Current vehicle automation technologies are     available, that although designed for the general public, may help drivers with PD stay on     the roads longer and safer than currently possible. Using a driving simulator (a safe and     cost-effective alternative with no impact on licensing for participants), this study will     investigate the feasibility and preliminary efficacy of utilizing in-vehicle technology     (i.e., a simulated lane change assistance system) to address critical driving errors in     individuals with mild to moderate Parkinson's disease.   "
6876|NCT03195959|"     Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to     extensive research in this field, there are more and better treatment options that allow     patients to participate in recreational activities at moderate altitude or bring up the     question of air-travel.      Still very few is known about the effects hypoxic conditions have on PH patients. The aim of     this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia     on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart     catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics     under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary     arterial and chronic thromboembolic pulmonary hypertension compared with control patients,     that are scheduled for right heart catheterisation due to dyspnea but have no PH.   "
6877|NCT03195946|"     This study will help determine which types of drugs that may interact with Lu AF35700   "
6878|NCT03195933|"     The stress-related hormone cortisol has been studied in depression for decades. However,     relatively little is known about the role of cortisol in psychological features of     depression. Basic research shows that cortisol modulates brain processes that are highly     relevant to depression (especially the neural substrates of negative biases in learning and     memory formation). However, very few studies have directly examined the effects of cortisol     on neural circuitry of learning in depressed humans. In addition, the effects of cortisol on     the neural substrates of learning differ for males and females. The toll of depression is     especially high in women, who are roughly twice as likely as men to suffer from depression.     Thus, the primary goal of this project is to investigate the effects of cortisol on the     neural circuitry of learning in depressed women.      A secondary goal is to investigate whether early life adversity moderates cortisol's effects     on the neural circuitry of learning. Animal data suggests that early life adversity causes     life-long biases toward learning in threatening conditions associated with elevated cortisol.     In addition, new data from humans suggests that alterations in cortisol traditionally     ascribed to depression may stem in part from early adversity rather than depression per se.     Thus, this study will examine effects of cortisol on the neural circuitry of learning in     depressed and healthy women with and without history of early life adversity.      The study will use pharmacological manipulation of cortisol levels (compared to placebo)     during measurement of brain activity at rest and during memory encoding of emotional and     neutral stimuli. The study will also measure whether cortisol alters the negative biases in     emotional memory often seen in depression. In doing so, the study will examine the role of     cortisol in neural networks associated with emotional learning that are often implicated in     depression.      Medications that target cortisol receptors in the brain may be beneficial in the treatment of     depression. However, this knowledge has yet to inform clinical practice, and mechanisms of     action of these medications are not well understood. This project is significant because it     provides the prerequisite knowledge (and develops a paradigm) that can be used in the future     in the development of more effective targeted intervention strategies.   "
6879|NCT03195920|"     This is a single arm, single center study to assess the safety and efficacy of a form of     extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.   "
6880|NCT03195907|"     This study evaluates the predictors of intensive care unit admission and mortality among     stroke patients and the effects of pulmonary physiotherapy on these stroke patients.     One-hundred patients participated in the pulmonary rehabilitation program and 81 patients     served as a control group.   "
6881|NCT03195894|"     The primary objective is to investigate differences in the alcohol consumption pattern     between alcohol addicts receiving conventional treatment and those who receive a combination     of conventional treatment and TripleA.   "
6882|NCT03195881|"     This study investigates the relationship between optic nerve sheath diameter and increased     intracranial pressure and its effect on neurologic outcome in post-cardiopulmonary arrest     patients.   "
6883|NCT03195868|"     This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects     the growth and distribution of nerves int he skin. Our previous study demonstrated that the     treatment we use here was effective at reducing the symptoms of neuropathy (as measured by     the modified total neuropathy score) in patients who had been treated with chemotherapy. The     current effort is designed to repeat this confirm this observation using a more extensive     battery of survey as well as to begin to elucidate the mechanism through which     photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic     patients differ in terms of response from chemotherapy patients   "
6884|NCT03195855|"     Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral     neuropathy can occur when the nerves carrying sensory information are affected. People with     diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which     affects function and associated with high NHS and social care costs. People with diabetes can     also have reduced movement at joints caused by increased stiffness in connective tissue.     Reductions in ankle and big toe movement leads to increases in the pressure over the sole on     the front part of the foot (the forefoot) when walking; this is a risk factor for ulceration.      The study will to assess whether ankle and big toe joint mobilisations and home program of     stretches in people with diabetic peripheral neuropathy improves joint range of motion and     reduces forefoot peak pressures.      Fifty eight people with diabetic peripheral neuropathy and a moderate risk of plantar     ulceration will be recruited from a local podiatry clinic. They will be randomly assigned to     an intervention (29 people) or control group (29 people). We will control for between-group     differences in age using a minimization process. The intervention will consist of a 6 week     program of ankle and big toe joint mobilisation by a physiotherapist and home stretches. The     control group will consist of usual care including podiatry interventions.      Outcome measures will be taken at baseline, post intervention and at 3 month follow up by an     assessor who does not know the group allocation. Primary outcome will be ankle range while     walking with secondary outcomes including big toe joint range, forefoot pressure while     walking and balance.      Changes over time between the groups will be compared statistically and the relationship     between ankle range of motion and peak plantar pressure will be analysed using linear     regression.   "
6885|NCT03195842|"     In this pilot study, limited English proficient (LEP) parents of children at Seattle     Children's Hospital for day surgery will be randomized to usual discharge care or usual     discharge plus language-concordant, audio-recorded instructions via recordable card. these     cards are similar to recordable greeting cards, and can record up to 180 seconds of     information. They can be played back over 100 times. We will follow-up with families 2-7 days     later to assess satisfaction and comprehension of discharge instructions.   "
6886|NCT03195829|"     This non-pharmacological interventional feasibility study evaluate a computerized cognitive     stimulation program in elderly with mild cognitive impairment.   "
6887|NCT03195816|"     This is a non-pharmacological study evaluating the impact of a computerized cognitive     stimulation program on verbal learning and on the progression white matter hyperintensities     in elderly with mild cognitive impairment.   "
6888|NCT03195803|"     This is a non-pharmacological study evaluating the differential effects of a computerized     cognitive stimulation program according to the existence or not of white matter     hyperintensities in elderly with mild cognitive impairment.   "
6889|NCT03195790|"     Pediatric obesity interventions for low-income populations are increasingly delivered in     children's homes, which may make treatment more accessible to families and enhance the     potency of the intervention in several ways. This randomized trial will directly test whether     delivering family-based behavioral interventions for pediatric overweight/obesity in the home     setting improves weight loss outcomes in low-income children relative to medical center-based     treatment. The trial will also quantify the cost-effectiveness of home visitation, and     explore the mechanisms accounting for observed treatment effects   "
6890|NCT03195777|"     The goal of this study is to develop strategies that will improve outcomes for patients with     deep vein thrombosis (DVT), using in vivo FDG-PET inflammation imaging to better predict the     development of the post-thrombotic syndrome (PTS). New approaches are needed to improve the     outcomes of patients with DVT, a disease that affects up to 600,000 patients per year in the     US alone. DVT acutely places patients at risk of death from pulmonary embolism and causes     50,000 deaths annually in the US. Moreover, up to 30-50% of patients will develop PTS, an     illness characterized by inflammation-driven fibrotic vein wall injury, and persistent     thrombus obstruction. PTS occurs despite anticoagulant therapy, and produces chronic     disability from leg pain, heaviness, edema, skin pigmentation, and ulcers; some patients may     even require amputation. PTS impairs quality of life to the same extent as chronic     obstructive pulmonary disease or diabetes. Therefore new diagnostic insights into PTS are     urgently needed.      There are several major challenges to improve outcomes in PTS: A) Limited in vivo knowledge     regarding inflammation and the development of PTS; B) L Lack of predictive approaches to     identify patients at high risk for PTS that will preferentially benefit from novel therapies.     Recently, our laboratories have harnessed FDG-PET molecular imaging to illuminate DVT     inflammation in vivo, and to provide a new strategy to diagnose recurrent DVT, a vexing     clinical problem (Hara et al. Circulation 2014). We now propose to further develop FDG-PET to     improve outcomes in DVT and PTS.      The objective of this application is to develop FDG-PET as an inflammation imaging approach     to assess DVT inflammation and predict risk of developing PTS in human subjects;      Hypothesis 1A: Inflammatory activity in DVT (quantified acutely, using FDG-PET imaging within     0-7 days after DVT) will predict PTS incidence (primary) and severity (secondary) within a 24     month follow-up period.      Hypothesis 1B: Inflammatory activity in DVTs (quantified sub-acutely, using FDG-PET imaging     within 21-28 days after DVT), will predict PTS incidence and severity.      Eighty patients with DVT will be imaged using FDG-PET/CT acutely (0-7 days of DVT diagnosis),     and sub-acutely (21-28 days after diagnosis). Subjects will be evaluated repeatedly for up to     2 years to detect clinical evidence of PTS (Villalta score), ultrasound findings for     structural venous injury, and soluble biomarkers of systemic inflammation. Subsequently, we     will evaluate the relationship between FDG DVT activity and the development of PTS.   "
6891|NCT03195764|"     T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential     anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) is a potent     anti-cancer agent in numerous human cancer cell lines. In addition, oral administration of     T-1101 (Tosylate) showed tumor growth inhibition in different mouse xenograft models of human     cancers. In this study, safety, tolerability and PK of T-1101 (Tosylate) will be evaluated     and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.   "
6892|NCT03195751|"     The scope of the research is to determine if a motion-based software development kit may     substitute for a manual goniometer. If so, this opens up the possibility of remote     telemonitoring of upper extremities patients.   "
6893|NCT03195738|"     The purpose of this study is to evaluate the feasibility and effects of a cognitive     intervention for youth following concussion   "
6894|NCT03195725|"     To investigate how discussions surrounding Do Not Attempt Cardiopulmonary Resuscitation     (DNACPR) decisions have changed following the Tracey judgement and how harm is being     defined by clinicians working within specialist palliative care in a hospice setting.   "
6895|NCT03195712|"     The study team's research fills the gap in the obesity literature where BMI with a cut point     of 35 is frequently used to show the association between BMI and metabolic syndrome     biomarkers. The study team was unable to locate any papers that showed the association     between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as     this clinical team has presented.   "
6896|NCT03195699|"     Many patients have cancers that have increased activity of a protein called STAT3 that     contributes critically to the development and growth of their cancer. Despite our knowledge     of STAT3's importance to cancer, scientists and doctors have not developed a drug that     targets it and that patients can take to treat their cancer more effectively than treatments     that are now available. StemMed, Ltd. has developed a compound, C188-9, which can be given by     mouth and acts as a direct inhibitor of STAT3. Administration of C188-9 to mice demonstrated     that it blocked growth of cancers of the breast, head and neck, lung, and liver and it was     safe when administered at high doses to mice, rats, and dogs. In this application, StemMed is     proposing to further develop C188-9 for treatment of solid tumors for which the prognosis is     dismal. The investigators will determine how safe it is when administered to patients with     cancer, determine whether an adequate dose can be administered to patients with cancer that     will block STAT3 in their cancer, and determine whether treatment with C188-9 leads to     reduced growth of their cancer.   "
6897|NCT03195686|"     Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric     patients   "
6898|NCT03195673|"     The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in     Carotid Artery Stenting   "
6899|NCT03195660|"     This study is designed to demonstrate feasibility of study conduct and that acceptable     adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently     hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the     criteria will receive ASV therapy.   "
6900|NCT03195647|"     The primary purpose of this pilot study will be feasibility of recruitment. However, in order     to further inform a full randomised controlled trial (RCT), information on the incidence of     AF and other arrhythmias, hospital length of stay, resource use and morbidity will be     collected.   "
6901|NCT03195634|"     Portal hypertension is a common complication of chronic liver diseases and is responsible for     most clinical consequences of cirrhosis. measurement of the hepatic venous pressure     gradient(HVPG) is the gold standard for evaluating the presence and severity of portal     hypertension, this technique is considered invasive and is not routinely performed in all     centers. Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a     secreted N-glycoprotein, which has been reported as a novel marker in assessing liver     fibrosis.However, the correlation of WFA+-M2BP with HVPG is unclear.The aim of this study was     to explore the relationship between WFA+-M2BP and HVPG.   "
6902|NCT03195621|"     Identifying the critical lesion of coronary artery disease and determining the interventional     plan are significant for reducing adverse cardiovascular adverse events. The assessment of     critical lesion requires the consideration of plaque morphology, tissue composition, and     endometrial stress which leading to rupture. In summary, accurate assessment of critical     lesions has high application value. In this study, patients with critical coronary artery     disease were divided into two groups: an accurate assessment group and a simple assessment     group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis,     potential cardiovascular risk, possible excessive intervention.   "
6929|NCT03195179|"     Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains     controversial whether initial urethral realignment after PFUI decreases rates of urethral     obstruction and the need for subsequent urethral procedures.      The proposed prospective multi-institutional cohort study should determine the utility of     acute urethral realignment after PFUI.   "
6907|NCT03195465|"     The purpose of this study is to determine if routine consumption of high antioxidant cacao     can have an effect on the behaviors of children with Autism Spectrum Disorder. This is     proposed as children with Autism Spectrum Disorder have elevated oxidative stress markers,     such as, free radicals making them highly vulnerable to oxidative damage. Thus, it is     proposed that foods high in antioxidant activity can offer protection against oxidative     stress and thus impact behaviors.   "
6908|NCT03195452|"     Raltegravir (RAL) is a very effective antiretroviral drug with a favorable long term     tolerability. RAL offers many advantages such as lack of drug-drug interactions, a good     safety profile particularly on lipids, inflammation and bone parameters. Ral can be an very     interesting for patient with comorbidities and comedications, intolerance or toxicities with     their current ARV treatment. However its current formulation of one tablet of 400mg twice a     day coul not suit many patients.      A new once-a-day formulation of RAL has been developed, with two tablets of 600 mg QD.     Pharmacokinetic study in healthy volunteers has shown that this dosing provides increased RAL     exposure compared to the standard formulation of 400 mg given twice a day.      The objective of this study is to evaluate the maintain of virologic suppression with     raltegravir 600mg 2 tablets qd as part of a triple antiretroviral regimen in virologically     controlled patients.   "
6909|NCT03195439|"     The study has 2 phases:        -  The Retrospective Phase (50 patients were diagnosed to have sepsis according to our          definition and criteria and 30 patients as a controlled cases )        -  The Prospective Phase (600 patients who will be admitted and monitored in ICU in order          to get at least 30 sepsis cases, according to our definition and criteria).      Measurements will be made from the forehead using the TTP's biocompatible sensor Unit that     will be attached to the skin. The SU will transfer data to the MCU.   "
6910|NCT03195426|"     This study aims at assessing the effectiveness of combined suprascapular nerve block (SSNB),     infraclavicular brachial plexus block (ICB) and supraclavicular nerve block (SCNB) as     surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary     objective is to test the hypothesis that SSNB-ICB-SCNB combination could spare the phrenic     nerve.   "
6911|NCT03195413|"     This study aims to determine whether early initiation of temporary nerve block therapy     improves patient satisfaction, decreases patient pain and discomfort, decreases the use of     dangerous medications such as narcotics, and frees hospital resources. Hand injuries, such as     blast injuries from fireworks, can be very painful. In the emergency department, providers     generally use narcotic pain medications to control pain, but these have significant side     effects. It is possible that temporary nerve blocks, guided by ultrasound, can be safe and     useful in the emergency department. They have been shown to be effective in several studies     around the country. The goal of this study is to build on the experience of others to     increase the use of US-guided regional nerve blocks as a form of pain management in hand and     distal forearm injuries in the Harborview Medical Center (HMC) emergency department. By     working with a multidisciplinary team, the study investigators hope to use this technique to     decrease narcotic use and improve pain control, and to provide important data for Emergency     Medicine physicians elsewhere who are considering incorporating this nerve block technique     into their practice.   "
6912|NCT03195400|"     Type 2 Diabetes (T2D) in obese youth is often preceded by a prediabetic state called:     Impaired Glucose Tolerance (IGT), which is associated with a pre-existing defect in insulin     secretion. This study intends to determine if genetic factors are associated with defects in     insulin secretion, the incretin system and hepatic insulin resistance in obese adolescents.     The long-term goal of this study is to generate information on both the genetics as well as     the pathophysiology of Type 2 Diabetes in Youth, which ultimately might guide the     investigators towards better preventive and treatment avenues.   "
6930|NCT03195166|"     Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated     doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in     elderly patients.      The aim of this study was to investigate the hemodynamic effects of continuous spinal     anesthesia in elderly patients undergoing knee arthroplasty.      Investigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess     modification blood pressure, stroke volume and cardiac output during anesthesia and specialy     after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it     off.      they recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours     after the end of surgery.   "
6993|NCT03194347|"     The aim of the planned research project is to find out the clinical significance of molecular     genetic analyzes in gynecological malignomas. In particular, it will be investigated how the     knowledge of a molecular-genetic finding affects the therapeutic decision of the physician.     Furthermore, genetic changes in the tumor tissue will be compared with the changes in CTCs,     DTCs and cfDNA.   "
6913|NCT03195387|"     This study follows a First-In-Human dose-escalation study of MMV390048 (5 to 120 mg MMV390048     powder-in-bottle formulation), a formulation bioavailability study to establish suitable     tablet formulation, and a two-part dose-escalation (40 to 120 mg of MMV390048) / induced     blood stage malaria (ISBM) challenge study with the new tablet formulation. After     identification of the predicted efficacious MMV390048 plasma concentrations in the IBSM     model, the current study will evaluate the chemoprotective efficacy of MMV390048 in a     standardised and validated controlled human malaria infection (CHMI) model using direct     venous inoculation (DVI) of aseptic, purified, cryopreserved, vialed P. falciparum     sporozoites (PfSPZ Challenge).      Three sequential cohorts of healthy men and women of non-childbearing potential (WONCBP) will     be administered the investigational medicinal product (IMP, i.e. MMV390048) under different     conditions. This may identify preventative regimens, to be further investigated in a Phase II     program. In the first two cohorts, protective administration of the IMP will occur 1 and 7     days before DVI of PfSPZ challenge. The timing of IMP administration and dosage in the last     cohort will be determined on the basis of emerging data from the preceding cohorts, but will     not exceed 28 days prior to the challenge nor 120 mg MMV390048.   "
6922|NCT03195270|"     The investigators are studying the ability of PET/MR imaging (using the PET tracer [18F]FDG)     to objectively identify and characterize pain generators in patients suffering from chronic     pain.   "
6923|NCT03195257|"     Investigate GIP effects on biomarkers involved in bone homeostasis   "
6914|NCT03195374|"     Chronic pain is a worldwide health problem due to its high prevalence and its difficult     management with a significant impact on quality of life. Pain and addiction co-occur     frequently. Indeed, the prevalence of addiction in patients with chronic non-cancer pain may     affect from 0% to 50% of patients (Højsted et al 2010). This large variability in the     estimation of addiction prevalence in chronic non-cancer pain patients is at least partly due     to a lack of standardization of the selected patients from the clinical or therapeutic point     of view and the lack of consensus in the use of a specific evaluation tool or gold standard.     Indeed, several tools are currently available at the international level with varying     efficiencies and precisions (Chou et al 2009, Turk, Swanson, and Gatchel 2008, Højsted and     Sjøgren 2007). In France, no data are available on the prevalence of analgesic opioid misuse     in chronic non-cancer pain patients, due to the lack clinical studies and validated tools in     French.   "
6915|NCT03195361|"     A prospective, single arm, multi-center clinical study to evaluate the safety and performance     of the SRS (Lyra Medical) vaginal mesh in POP patients   "
6916|NCT03195348|"     This study is a collaboration between the Centre of Human & Aerospace Physiological Sciences     (CHAPS) and the Sleep and Brain Plasticity Centre (Department of Neuroimaging) at King's     College London and the Sleep Disorders Centre at Guy's Hospital.The main purpose of the study     is to evaluate the effects of a 7 day unloading period (simulating micro gravity) on muscle     mass using three independent methods; two scanning techniques (magnetic resonance imaging     (MRI) and dual x-ray absorptiometry (DXA)) and one that involves swallowing a capsule that     contains a harmless chemical called creatine (D3-Creatine (D3-cr)) and then measuring its     concentration in urine. In order to induce muscle loss, participants will be required to lie     flat on their back on a water bed filled with water and salt (called hyper-buoyancy flotation     (HBF)). As this situation is similar to that experienced in space, the investigators will     also measure the effect of HBF on sleep, brain and physiological function - all things known     to change in astronauts. Sixteen male subjects (18-40 yrs) will be recruited to participate     in the study that will require physiological testing before, during and following both 7 days     of normal conditions and 7 days of HBF bed-rest. Each subject will be exposed to the same     conditions and assessments over the study period. As some loss of muscle is expected,     participants will be offered an exercise rehabilitation programme upon completion of HBF with     self-monitored and/or guided sessions based on those provided by the Space Medicine Office of     the European Space Agency to returning astronauts.   "
6917|NCT03195335|"     Cerebral Palsy (CP) is the most common cause of physical disability in children, is a     non-progressive neurological impairment resulting from an injury in the developing brain and     causing various problems related to sensory, perception, cognition, and movement. This     problems leads activity and participation levels of the children with CP. In the literature     various assessment tools developed for assessing participation. Assessment of Life Habits     (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life     and participation in detail. The scale is originally in French but English and German     versions are also available. The aim of this study is to translate the scale to Turkish and     to determine validity and reliability of Turkish version of Life Habits questionnaire.   "
6918|NCT03195322|"     Primary Objective:      • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a     population of women undergoing bilateral mastectomy followed by immediate, bilateral     pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage.      Secondary Objectives:        -  To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale          and Brief Pain Inventory—Short Form at Day 1-60 after tissue expander placement        -  To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after          mastectomy and tissue expander placement.        -  To describe short-term changes in Quality of Life scores after mastectomy and tissue          expander placement.        -  To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after          mastectomy and tissue expander placement.        -  To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final          reconstruction with tissue expander exchange for permanent implant.        -  To describe short-term changes in Quality of Life scores after final reconstruction with          tissue expander exchange for permanent implant.        -  To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final          reconstruction with tissue expander exchange for permanent implant.        -  To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after          final reconstruction with tissue expander exchange for permanent implant.        -  To describe average hospital length of stay in patients after final reconstruction with          tissue expander exchange for permanent implant.        -  To describe the patient's final assessment of pre-pectoral reconstruction from free-form          text.      Tertiary Objectives:      • To measure cosmetic result and associated residual pain with Alloderm® reinforcement of     breast pocket.   "
6919|NCT03195309|"     To compare the postoperative analgesic effect and the intensity of motor block in different     concentration ropivacaine plus fentanyl when used epidurally with a patient-controlled     analgesia device after Cesarean delivery.   "
6931|NCT03195153|"     Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial     clinical and experimental evidence suggest that both diabetes and insulin resistance cause a     combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the     vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial     dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular     disease. It has been implicated as an independent risk factor for cardiovascular disease and     premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as     well as for patients with essential hypertension. A complete biochemical understanding of the     mechanisms by which hyperglycemia causes vascular functional and structural changes     associated with the diabetic milieu still eludes us. In recent years, the numerous     biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of     diabetic vascular disease have been distilled into several unifying hypotheses. The role of     chronic hyperglycemia in the development of diabetic microvascular complications and in     neuropathy has been clearly established. However, the biochemical or cellular links between     elevated blood glucose levels, and the vascular lesions remain incompletely understood. A     number of trials have demonstrated that statins therapy as well as angiotensin converting     enzyme inhibitors is associated with improvements in endothelial function in diabetes.     Although antioxidants provide short-term improvement of endothelial function in humans, all     studies of the effectiveness of preventive antioxidant therapy have been disappointing.     Actually, control of hyperglycemia thus remains the best way to improve endothelial function     and to prevent atherosclerosis and other cardiovascular complications of diabetes.   "
6920|NCT03195296|"     Graves orbitopathy (GO) is an inflammatory eye disease associated in 95% of patients with     Graves' hyperthyroidism (GH), in ~3-4% with hypothyroid autoimmune thyroiditis, and in ~1-2%     with thyroid autoimmunity in the absence of thyroid dysfunction, the former known as     euthyroid GO. The pathogenesis of GO is autoimmune, with the TSH-receptor being considered     the major autoantigen, thereby establishing a pathogenetic link between the thyroid and     orbital tissue. Thus, TSH-receptor is expressed by orbital fibroblasts, where it forms a     complex with the IGF-1 receptor. Unlike GH, which is notoriously caused by TSH-receptor     stimulating autoantibodies, GO is believed to reflect cell-mediated autoimmunity, as     suggested by studies showing a Th1-like pattern of cytokine release by primary cultures of     orbital infiltrating lymphocytes from GO patients. On the other hand, a role of B lymphocytes     has emerged in recent years based on the observation that the anti-CD20 monoclonal antibody     rituximab has a beneficial effect on GO activity, as demonstrated by a recent randomized     clinical trial in which rituximab was compared with intravenous glucocorticoids (GC), being     the former the standard treatment of moderately-severe GO. The explanation for the findings     was that B lymphocytes are involved in the pathogenesis of GO as antigen-presenting cells.     However, in spite of the above mentioned promising observations, another randomized clinical     trial in which rituximab was compared with placebo provided opposite results. Thus, rituximab     had no effect at all on GO. Data from the two studies were confronted and major differences     between the two cohorts emerged, especially concerning GO activity, leading to the conclusion     that rituximab may be effective for active, but not for inactive GO. Rituximab has been     employed also for autoimmune diseases other than GO, including type 1 diabetes. In the     former, it was shown that the effectiveness of rituximab paralleled the presence of     CD20-positive infiltrating lymphocytes in pancreas islets. We therefore postulated that     something similar may occur in GO, because of which we planned the present, perspective,     observational study, aimed at determining the presence and immunohistochemical features of     lymphocytes infiltrating orbital tissues in patients with GO and to relate them with the     clinical features of GO.   "
6925|NCT03195231|"     Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's     disease ）which may not just interfere with the motor symptoms of PD but can also cause     immense personal suffering as well as decreased quality of life with increased disability and     caregiver burden. However,there is little hard evidence to guide clinical treatment. Although     some newer dopamine agonists also have antidepressive effect, the use of tricyclic or     nontricyclic antidepressants is frequently required.However, the side-effects of these agents     may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine     which is made by cultivating Xylariasp mycelium using submerged fermentation technology.     Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used     to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder     has been confirmed in clinical, but not in the patients of Parkinson`s disease. Therefore,     the investigators design a randomized, double-blind, placebo-controlled study to evaluate the     antidepressant effect of Wuling powder in PD patients and its underlying mechanism.   "
6926|NCT03195218|"     STUDY PURPOSES: This study aims to evaluate a high resolution microendoscope (HRME): 1) To     assess the sensitivity and specificity of the HRME device in the detection of cervical     intraepithelial neoplasia grade 2 (CIN2) or histologically more severe lesion (NIC2+) and     cervical intraepithelial neoplasia grade 3 (CIN3) or histologically more severe lesion     (NIC3+) in a comprehensive case-by-case basis; 2) Compare the accuracy of the HRME device     with acetic acid visualization (VIA) and colposcopy. METHODOLOGY: 1,780 women with abnormal     Pap Smears (ASCUS+) or positive high-risk human papillomavirus (HPV) test in the cervix     performed in the Barretos Cancer Hospital (HCB, Barretos, Brazil) screening program will be     recruited, either at Mobile Prevention Units or Fixed Units, who have been referred for     diagnostic investigation with colposcopy. The invitation for women to participate in the     study will be made immediately before the medical consultation for colposcopy, in the     Prevention Department of Barretos Cancer Hospital. Women who decide to participate in this     study will sign an Informed Consent Form after invitation and relevant explanations, which     will be provided by the researcher in charge or by a representative with previous training     appointed by him for the application of the Form in question. During the colposcopy     examination, the HRME device will be used to check the presence of precursor lesions in the     cervix. HRME will capture images from all areas considered abnormal by VIA and/or colposcopy.     Any abnormal areas detected by VIA and/or colposcopy will undergo a biopsy. If no abnormal     area is observed, a cervical microbiopsy will be obtained from an apparently normal area     examined using HRME. If during the study a precursor disease or cervical cancer is detected     in any woman, an appropriate treatment will be offered by Barretos Cancer Hospital according     to an institutional protocol.   "
6927|NCT03195205|"     Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United     States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in     Pennsylvania are living with hepatitis C. In 2010, Center for Rural Pennsylvania estimated     that 27% of population of PA live in one of Pennsylvania's 48 rural counties. Under this     estimate, there are over 43,000 individuals affected with chronic HCV living in rural     Pennsylvania. Rural county residents often experience barriers to health care by having fewer     primary care providers and limited specialty care physicians available to them to address     their healthcare needs.      RQ1: Will the community based delivery system for Hepatitis C screenings see an increase in     positivity rates?      HO1: There is no relationship between the community based delivery system with an increase in     the Hepatitis C screening positivity rates.      HA1: There is a relationship between the community based delivery system with an increase in     the Hepatitis C screening positivity rates.   "
6928|NCT03195192|"     This is an open-label, multicenter study in patients with metastatic breast cancer who are     candidates for standard first line treatment with palbociclib plus endocrine therapy. To be     eligible, patients must have received no prior chemotherapeutic or hormonal regimen for     metastatic disease. However, patients may still be considered eligible if they have already     started treatment with endocrine therapy (an aromatase inhibitor or fulvestrant) plus     palbociclib for no longer than 4 weeks prior to study enrollment, as long as they meet all     other eligibility criteria. Eligible patients must have had a diagnostic biopsy of the     metastatic lesion no more than 4 months prior to study enrollment and with sufficient tissue     to complete the proposed biomarker analysis. Patients who develop disease progression within     the first 24 months of starting palbociclib plus endocrine therapy will be eligible for an     optional additional tissue biopsy at time of disease progression to repeat the analysis at     time of disease progression and obtain real-time (10-14-day turn-around) multi-omic data     produced under College of American Pathologist (CAP)/Clinical Laboratory Improvement     Amendments (CLIA) development and/or compliant practices.   "
6932|NCT03195140|"     A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old     with type 1 diabetes (T1D).   "
6933|NCT03195127|"     As the general population ages and technology advances, many who suffer from catastrophic     critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome)     survive only to find themselves severely physically debilitated and compromised from a     pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath.     Oftentimes, these patients require a long course of physical rehabilitation and ventilator     support. These patients frequently remain ventilator dependent for greater than 3 weeks, and     are thus referred to as requiring prolonged mechanical ventilation (PMV).      Older patients are at significantly higher risk for requiring PMV for reasons that are not     entirely clear, but which may include physical deconditioning, impaired cardiopulmonary     physiology, and cognitive or behavioral disturbances.      The purpose of this study is two fold: 1. to characterize the functional phenotype of     ventilator dependent, and recently ventilated patients with respect to general strength,     endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a     rehabilitation protocol that targets improving this populations disabilities through     exercises focused on improving strength, endurance, balance, and pulmonary functioning.   "
6934|NCT03195114|"     The objectives of this study are to: a) evaluate and correlate the severity of paravalvular     leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after     transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO     bioprostheses; b) assess the inter and intraobserver variability of both imaging methods; and     c) correlate the severity of PVL with post-TAVR changes in LV remodeling and clinical     outcomes.   "
6935|NCT03195101|"     Many surgical approaches for excision of orbital tumors have been described. These approaches     do not allow access to all orbital quadrants. Furthermore, some of these approaches are     technically difficult, associated with long morbidity and post operative pain, having high     rate of complications or having unacceptable cosmetic appearance. the investigators present     the transconjunctival approach as an alternative procedure that allows access to orbital     tumors in different locations as well as less morbidity and better cosmetic results   "
6936|NCT03195088|"     The primary objective of this trial is to investigate the safety and tolerability of single     rising doses of BI 473494 in healthy male subjects.      The secondary objective is the exploration of PK including dose proportionality, and PD of BI     473494 after single dosing.   "
6937|NCT03195075|"     Endoscopic ultrasonography is a widely accepted modality for the diagnosis of     gastrointestinal and pancreatic-biliary diseases.      Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative     procedure to percutaneous trans-hepatic biliary drainage, with a technical success between     75%-100% and with low complication rate. Other important advantage of endoscopic     ultrasonography-guided biliary drainage compared with external percutaneous trans-hepatic     biliary drainage is better quality of life due to the internal placement of the stent.   "
6938|NCT03195062|"     In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past     fifty years, the generalization of added sugar in processed food led to a marked increase in     fructose consumption in almost all countries, and epidemiological studies demonstrated that     the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is     associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity.      The objective of the study is to measure the amount of fructose that escape first-pass     hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its     metabolic fates with the use of tracers.   "
6939|NCT03195049|"     Exchange transfusion is effective and considered to be safe procedure ; however, it is not     without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%.     therefore ,the current recommendation for performing exchange transfusion are based on     balance between the risks of encephalopathy and complications related to the procedure .   "
6940|NCT03195036|"     There is substantial evidence that early childhood development (ECD) programming can improve     child health and development outcomes. An important component of ECD programming is     supporting positive parenting and early stimulation practices. While many parents could     benefit from such programming, mothers that are HIV-infected may particularly benefit given     the higher risks of poorer child development among HIV-exposed children. Catholic Relief     Services (CRS) in Cameroon is implementing the Key Interventions to Develop Systems and     Services (KIDSS) ECD program for HIV-exposed children. The program will include home-,     facility-, and community-based components. This impact evaluation will ascertain to what     extent the KIDSS home-based component of the ECD model affects attainment of age-appropriate     developmental milestones (measured by the Ages and Stages Questionnaire 3 (ASQ-3)) in     HIV-exposed children in Cameroon. The study design is a cluster-randomized controlled trial     with a cohort of 200 mother/child dyads across 10 study clinics. HIV+ mothers will be     recruited during pregnancy and their children will be followed up until 18 months of age. The     intervention group will receive regular home-based ECD services focused on positive parenting     and early stimulation as well as exposure to facility- and community-based ECD programming.     The control group will only have exposure to the facility- and community-based ECD     programming. Randomization occurs at the clinic (cluster) level.   "
6941|NCT03195023|"     This study evaluates the effect of renin-angiotensin blockers on chronic kidney disease     progression in elderly (>65 years old) patients with non-proteinuric nephropathies. Half of     the patients will receive angiotensin converting enzyme inhibitors, while the other half will     not receive them. Renal function, proteinuria and cardiovascular events will be follow up     during a three year period.   "
6942|NCT03195010|"     This pilot clinical trial compares the safety of two different platelet transfusion     thresholds among patients with blood cancer or treatment-induced thrombocytopenia whose     condition requires anticoagulant medication (blood thinners) for blood clots. Giving     relatively fewer platelet transfusions may reduce the side effects of frequent platelet     transfusions without leading to undue bleeding.   "
7062|NCT03193450|"     It was suggested that the patient compliance plans an important role in the Hp eradication.     However, data on whether re-education could improve the eradication rate are lacking. We     consider that re-education on patients by telephone during the process of drug administration     could increase the eradication rate in Hp infected patients.      We hypothesized that telephone re-education during the whole process of drug administration     would improve the compliance of patients and ultimately increase the Hp eradication rate.   "
6943|NCT03194997|"     Breast cancer is one of the most common types of cancer in Brazil, and its treatment, namely     surgery, chemotherapy, radiotherapy or hormone therapy, has consequences and side effects     that significantly affect the quality of life and associated physical and psychological     factors. The practice of physical activity, in turn, may play a beneficial role in these     factors, and help the recovery of the patient in relation to the consequences of the     treatments. Two types of physical activity can be addressed in the context of breast cancer;     Dance and the Pilates method. Thus, the objective of the present study will be to analyze the     impact of Pilates practice and dance on quality of life and on psychological and physical     factors in patients undergoing adjuvant treatment of breast cancer. Patients older than 18     years who are in adjuvant treatment, namely, chemotherapy, radiotherapy and / or hormone     therapy at the Oncology Research Center - CEPON, will be invited to be part of the study.     With a randomized clinical trial of three arms, the patients will be submitted to 16 weeks of     intervention, and randomized in 3 groups: (A) belly dance protocol group; (B) Pilates method     protocol group, and (C) control group who will continue with their routine activities. Sample     randomization will be conducted in confidence by one of the researchers in a specific     computer program. Information about personal and clinical characteristics, quality of life,     psychological factors (depressive symptoms, body image, self-esteem, optimism, perceived     stress, fatigue, pain, sexual function and sleep quality) and physical factors     (cardiorespiratory fitness, balance , Posture, upper limb functionality and presence of     lymphedema). All information will be collected before and after the intervention period.     Statistical analysis will use the statistical package SPSS - IBM, version 20.0. Firstly,     descriptive statistics (mean, standard deviation and percentage) will be used in order to     know the data, and then the Anova two way test with repeated measurements and Sydak     Comparison Test, in order to analyze the data. Groups of the Pilates method, of the dance and     control group. Significance level of 5%.   "
6944|NCT03194984|"     To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute     risk and intensity of dentin sensitivity due to dental bleaching in the office with 35%     hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent,     South Jordan, UT, USA) in the same arch in patients of different age groups: 18 to 25 years     and 40 to 65 years. Data will be collected, tabulated and submitted to statistical analysis   "
6945|NCT03194971|"     This study will assess whole brain samples from glioblastoma patients at autopsy to determine     the underlying pathological signatures of tumor treatment fields at autopsy.   "
7136|NCT03192501|"     This study prospectively evaluates whether the use of iCAGES (integrated CAncer GEnome Score)     tool in guiding the treatment of advanced cancers is superior to current standard care in     progress free survival (PFS),overall survival (OS),and improvement of life quality.   "
6946|NCT03194958|"     Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri     to compare the relative and combined effects of these two strategies for augmenting an     existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will     receive standard Missouri quitline services and half will receive new Specialized Quitline     services targeted to this group. In each of these groups, half also will receive calls from a     trained navigator to help them address unmet Basic Needs and the accompanying psychological     distress that act as barriers to smoking cessation.   "
6947|NCT03194945|"     Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce     glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of     patients with response gradually decreases over time. There is no consensus on which     treatment should be given in order to maintain the benefit in glycemic control and β cell     recovery. In this multi-center, randomized, controlled study, effects of various sequential     treatments ( metformin, linagliptin and combined with both drugs) on long-term blood glucose     control as well as preservation of β cell function after SIIT were investigated.      In total, 448 patients with newly diagnosed type 2 diabetes who meet the inclusive criteria     will be enrolled in eight centers in China. After baseline assessments, all patients will be     treated with insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of     intensive treatment, insulin pump will be stopped. Different treatments will be applied to     patients for 48 weeks according to randomization: Group A: Linagliptin 5 mg Qd + Metformin     0.5 g bid; Group B: Linagliptin 5 mg Qd; Group C: Metformin 0.5 g bid; Group D: No oral     drugs. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7%     at the end of the study. Secondary endpoints include proportion of patients achieving     glycosylated hemoglobin A1C <6.5% at the end of study; differences in β-cell function ,     insulin sensitivity, GLP-1 and glucagon secretion among treatment groups, and differences in     adverse events among treatment groups.   "
6948|NCT03194932|"     The purpose of this study is to test the safety of venetoclax and to find the highest dose of     venetoclax that can be given safely when it is combined with one or two chemotherapy drugs     (cytarabine or cytarabine and idarubicin). This study tests different doses of venetoclax to     see which dose is safer in children with leukemia.      PRIMARY OBJECTIVE: Determine a tolerable combination of venetoclax plus chemotherapy in     pediatric patients with relapsed or refractory acute myeloid leukemia (AML).      SECONDARY OBJECTIVE: Estimate the overall response rate to the combination of venetoclax and     chemotherapy in pediatric patients with relapsed or refractor AML.   "
6949|NCT03194919|"     The primary purpose of the current study is to test the effect of providing users of     automated web-based smoking cessation interventions with the option of negotiating and     re-negotiating the quit date.   "
6950|NCT03194906|"     Children with brain tumors who have had radiation therapy are at risk for problems with     attention, memory, and problem solving. Such problems may cause difficulty in school and     daily life. Memantine, the drug being used for this study, is not yet approved for use in     children by the U.S. Food and Drug Administration. However, studies have shown some     improvements in memory for patients with dementia, Attention Deficit Hyperactivity Disorder,     and autism. Scientists have also used this medication for adult cancer patients receiving     radiation therapy with results showing less cognitive declines over time compared to patients     taking a placebo (inactive pill). These studies have also shown few side effects.      This is a pilot/feasibility study and the first known study involving children with a cancer     diagnosis or brain tumor.      PRIMARY OBJECTIVES:        -  To estimate the participation rate in a study of memantine used as a neuro-protective          agent in children undergoing radiotherapy for low grade glioma        -  To estimate the rate of memantine medication adherence        -  To estimate the rate of completion of cognitive assessments      SECONDARY OBJECTIVES:        -  To estimate the effect size of change in neurobehavioral outcomes (cognitive, social,          quality of life, neurologic) associated with memantine        -  To evaluate the frequency and nature of memantine side effects as measured by the          Systematic Assessment for Treatment Emergent Events (SAFTEE)   "
6951|NCT03194893|"     The purpose of this study is to provide continued treatment with alectinib or crizotinib as     applicable to participants with ALK- or RET positive cancer who were previously enrolled in     any Roche-sponsored alectinib study and who are deriving continued clinical benefit from     alectinib or crizotinib in the parent trial at the time of parent trial closure.   "
7318|NCT03190070|"     Single arm physiological study to measure renal functional reserve as a biomarker of kidney     function and health   "
6952|NCT03194880|"     Two new rapid HIV tests by Alere™ have the potential to substantially decrease the window     period for rapid tests. First, the Alere™ HIV Combo is a rapid fourth generation test. The     performance in a laboratory based setting was recently assessed at the Thai Red Cross     Anonymous Clinic Laboratory in Bangkok, Thailand (personal communication). Of 50 confirmed     acute HIV samples, Alere™ HIV Combo could detect 37 (74%), while none of these 50 cases could     be identified by the currently used third generation tests. These data have not yet been     published, but the preliminary results indicate a very favorable performance of the Alere™     HIV Combo in a facility-based laboratory setting.      Second, the Alere™ q HIV-1/2 Detect is a qualitative, cartridge based, nucleic acid     amplification test designed for Point of Care use. Data from several early infant diagnosis     studies in Sub-Saharan African countries have assessed the performance of the Alere™ q     HIV-1/2 Detect. The test was performed in the field, by a range of health professionals, from     nurses and laboratory technicians to medical doctors. The pooled analysis showed a     sensitivity of 99.07% (95%CI 95.48 - 99.95%) and a specificity of 99.94% (99.72-100%).   "
6953|NCT03194867|"     Primary Objective:        -  To evaluate the safety and tolerability of the combination of Isatuximab (also known as          SAR650984) and REGN2810 in patients with relapse/refractory multiple myeloma.        -  To evaluate the overall response rate of the combination of Isatuximab and REGN2810 in          patients with RRMM.      Secondary Objectives:        -  To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of          response (DOR), time to response (TTR), progression free survival (PFS), and overall          survival (OS).        -  To assess the pharmacokinetics (PK) of Isatuximab and REGN2810 when given in          combination.        -  To assess the immunogenicity of isatuximab and REGN2810.   "
30898|NCT02881307|"     The purpose of this research study is to evaluate if a weight loss intervention will improve     your rheumatoid arthritis disease activity.   "
6954|NCT03194854|"     Subjective well-being is a positive state affairs in six domains of life: interpersonal,     community, occupational, physical, psychological, and economic (I COPPE). The purpose of the     study is to evaluate the effectiveness, feasibility, and acceptability of an online     intervention named Fun For Wellness (FFW), designed to promote skills and self-efficacy in     the multidimensional I COPPE domains of life.   "
6955|NCT03194841|"     The purpose of this study was the development, and testing of a HF application that was used     to provide self-care support to HF patients through a smartphone device. The study appraised     current available literature on HF to determine best practices for promoting self-care of HF     through direct communication with individuals with HF living at home. For the purpose of this     study, smart phone communication was utilized. Smart phone applications allow patients to     transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to     healthcare providers. Using a secure website, a healthcare worker can access the information     and contact the patient via the mobile phone when their data is out of normal range. This     study was novel in its approach from what is traditionally offered in that it supported     patient self-care decisions by promoting symptom monitoring and offered both tactical and     situational skills strategies through at the point education.   "
6956|NCT03194828|"     This study will evaluate the effectiveness of real-time data collected on patients taking     topical medication to treat glaucoma. Patients will be randomized to two groups, the first of     which will only use the study device to take their medication, while the second will use the     study device and receive on-demand reminder messages, when necessary.   "
6957|NCT03194815|"     A randomised phase II double-blinded placebo-controlled trial designed to explore the utility     of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes     (NMDA-receptor or Voltage Gated Potassium Channel).      Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients     with acute psychosis associated with anti-neuronal membranes.      Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with     acute psychosis associated with anti-neuronal membranes.   "
6958|NCT03194802|"     The aims of the study are to determine whether an online drug tapering program can lead to     successful drug tapering in hypnotic dependent insomnia and whether such tapering is     associated with improved daytime functioning and sleep.   "
6960|NCT03194776|"     This study is designed to determine whether LLG783 displays the clinical safety and efficacy     profile, after multiple i.v. doses, to support further development in patients with PAD and     intermittent claudication.   "
6971|NCT03194633|"     Chronic kidney disease (CKD) and hypertension are two closely related common chronic diseases     that have serious implications to human health. Hypertension is a major cause for progression     of renal disease and a risk factor for cardiovascular disease (CVD). Control of Blood     Pressure (BP) to target is now considered to be the main goal in the treatment of patients     with CKD.      In clinical practice, it is difficult for CKD patients with hypertension to achieve systolic     BP (SBP) or diastolic BP (DBP) goal; oftentimes, calcium channel blocker (CCB) class of     drugs, for example, nifedipine gastrointestinal therapeutic system (GITS), is used in such     patients. Previous data have demonstrated nifedipine to be having a significant dose-response     relationship; that is, nifedipine 60 mg provided better BP reduction than 30 mg. However,     there are limited studies that have evaluated the efficacy and tolerability of nifedipine     GITS 60 mg in Chinese CKD patients with hypertension. Hereby, the objective of this study is     to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg treatment in a large     cohort of CKD patients with uncontrolled hypertension.   "
6961|NCT03194763|"     Congenital heart defects are the most frequent manifestation of congenital diseases (8 per     1000 live births). Imaging modalities play an increasing role in their diagnosis, follow-up,     and pre/post-surgery check-up. Echocardiography usually provides a first line diagnosis, but     Coronary CT Angiography (CCTA) also demonstrated its usefulness whenever accurate modelling     of anatomic structures is required.      CCTA is well defined for adult patients. This is not the case for paediatric population,     which rises two main difficulties:        -  The use of ionising radiation in young subjects involves a very radio-sensitive          population, potentially subject to multiple exams during their follow up.        -  Technical issues related to young patients: No breath-holding, uncontrolled movements          during acquisition, very high heart rates (making ECG gating more complex) and very          small structures.      These conditions usually result in a deteriorated image quality or in radiation dose increase     (retrospective gating). These two outcomes are not acceptable for both, clinician and     patient.      In this study, investigators make the hypothesis that despite difficult conditions stated     above, ultra-low dose acquisitions may results in diagnostic quality acquisition, thanks to     state of art CT technologies combined with acquisition parameters specially designed for that     purpose.      Investigators aim to demonstrate feasibility and performances of such exams.   "
6962|NCT03194750|"     Renal failure and resuscitation measures in critically ill patients can result in fluid     overload. Fluid overload in renal failure patients can cause harmful effects like pulmonary     edema, anasarca and congestive cardiac failure exacerbations among other complications. These     have been associated with increased time on the ventilator, increased length of stay in the     ICU, and higher overall mortality for patients requiring dialysis in the ICU.      The current standard of care for adjusting fluid removal rates in patients on continuous     renal replacement therapy relies on clinical judgement. Clinicians take into account factors     like the patient's condition, vasopressor requirements, kidney function, total intake and     outputs, vital signs, and physical examination findings when making daily changes to fluid     removal rates on dialysis machines. Such assessment is highly subjective and can be     imprecise/inaccurate leading to hypotension and hemodynamic instability in a critically ill     patient.      Use of conventional ultrasound by physicians to assess volume status using compressibility of     the inferior vena cava has been shown to be a reliable predictor of volume status and can     help guide therapy. Such use makes bedside volume assessment a non-invasive, rapid,     repeatable point of care tool that can provide objective data to guide fluid removal     determine velocity of fluid removal and help identify patients at risk of hypotension and     hemodynamic instability during the process of fluid removal. Apart from rare possible local     allergic reactions to ultrasound jelly and transient local discomfort, the disadvantages are     minimal. Ultrasonography has been considered a safe imaging modality. This protocol will     measure inferior vena cava compressibility using the General Electric VScan with Dual Probe,     which has FDA approval for abdominal and vascular imaging in humans.   "
6963|NCT03194737|"     Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with     acute urinary retention secondary to benign prostatic hyperplasia (BPH).   "
8871|NCT03169790|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with with CD20-positive NHL who have progressed on or after rituximab     therapy.   "
6964|NCT03194724|"     The relationship between infections and malnutrition is synergistic, each further     compromising the outcome of the other. Malnutrition compromises natural immunity leading to     increased susceptibility to infections, more frequent and prolonged disease episodes, and     increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition     through decreased appetite and food intake, nutrient malabsorption, nutrient loss or     increased metabolic needs. Severe malnutrition often masks symptoms and signs of infectious     diseases making prompt clinical diagnosis and treatment very difficult. Another issue is that     infections (as well as overweight and obesity status) affect nutritional biomarkers making it     difficult to assess the real magnitude of some nutritional problems. This is the case of     vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or     more of a defined population has a serum retinol concentration of less than 0.7 µmol/L.   "
6965|NCT03194711|"     The single center retrospective study evaluates the acute and long term outcomes of     bioabsorbable drug-eluting scaffolds (BVS) implantation in 50 consecutive coronary artery     disease (CAD) patients using optical coherence tomography (OCT) imaging.   "
6966|NCT03194698|"     Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual     acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both     conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film     and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry     eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long     term improvement of symptoms for patients by improving the quality of meibum, increasing     meibum flow, improving tear film stability and decreasing inflammation.      Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation,     topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers,     intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses,     among other. Despite this variety of symptoms, patients often do not experience complete or     long term relief of symptoms.      Forced meibomian gland expression (MGX) has been shown to be an effective method of     rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are     forcefully compressed to express gland contents. Research has shown improvement in patient     symptoms with the use of MGX.      Intense pulsed light (IPL) have been used in dermatology to treat various conditions.     Patients with DED who have tried other therapies and found no relief, often resort to IPL as     a last resort. Research has shown IPL alone may be effective in improving patient symptoms.     In addition, such studies have failed to show significant adverse events with the use of IPL.      Here, we propose a prospective, randomized, case controlled clinical pilot study to examine     the efficacy for both subjective and objective measures. 20 patients with DED will be     recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL.     Objective measures will include tear cytokine levels, impression cytology, meibography, tear     osmolarity and others. Subjective measures will include quality of life screening tools.      We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective     dry eye symptoms and objective measures. Given the lack of adverse effects reported in the     literature, we do not anticipate adverse effects in our study.      Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no     contact with subjects or biospecimens.   "
6967|NCT03194685|"     A Phase 1/2a dose escalation and dose ranging study of FF-10101-01 in subjects with relapsed     or refractory acute myeloid leukemia to determine the safety, tolerability, PK and     preliminary efficacy. A total of 9 cohorts will be enrolled in Phase 1 to establish the     Maximum Tolerated Dose (MTD). Phase 2a will consist of up to 3 dose levels (high, medium, and     low) of which subjects with FLT3 mutations will randomly be assigned.   "
6968|NCT03194672|"     Randomized trial of a rapid repeat pregnancy prevention program for adolescent mothers.      Five hundred adolescent mothers from central Ohio will be enrolled--half will be assigned to     an intervention that features nurses and social workers providing extra assistance during     late pregnancy and the early postnatal period and half will be assigned to a standard of care     intervention.      OhioHealth is the lead entity. Nationwide Children's Hospital serves as the local independent     evaluator.      This federally funded contract is supported by the Family and Youth Services Bureau.   "
6969|NCT03194659|"     The purpose of this study is to determine whether choline supplementation influences the     availability of docosahexaenoic acid throughout pregnancy.   "
6970|NCT03194646|"     The study is performed to assess the efficacy and safety of Vilaprisan in subjects with     uterine fibroids compared to standard of care   "
6973|NCT03194607|"     Low back pain is a leading cause of medical consultations in France and in other     industrialized countries. Although spinal surgery is a recognized treatment, to date, its     impact has only been assessed using subjective or declarative criteria. Yet, in many     orthopaedic diseases, it has been shown that the evaluation of functional capacities,     including walking speed, is particularly useful to study the impact of these diseases and     their treatment. To date, no study has attempted to assess the impact of spinal surgery by     evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of     locomotion and joint dynamics. The investigators hypothesize that spinal surgery in patients     with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable     locomotion parameters, and in particular walking speed. Walking speed is a quantitative     measurement, which could reflect the degree of functional impairment of the patient before     and after surgery.   "
6974|NCT03194594|"     Ketamine and dexamethasone have been known to be effective postoperative pain. Many studies     also have reported these two drugs might change mood such as depression. This study aimed to     investigate the effect of each drug individually with their combination on perioperative     change of mood in patients undergoing gynecologic surgery   "
6975|NCT03194581|"     This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation     as a measure of the effect of blood loss on DO2 during surgical procedures.   "
6976|NCT03194568|"     This study will assess whether Anterior Vertebral Tethering is a safe and feasible method of     anterior approach surgery for spinal deformity in pediatric scoliosis.   "
6995|NCT03194321|"     The purpose of this study is to demonstrate the safety of tacrolimus extended-release in HLA     sensitized (HS, defined as panel reactive antibody ≥ 30%), kidney transplant recipients after     desensitization with intravenous immunoglobulin (IVIG) and rituximab +/- plasma exchange     (PLEX) per the standard of care with alemtuzumab induction.   "
6996|NCT03194308|"     Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic     settings need prevention strategies to reduce periconception HIV acquisition risk. Women at     high risk for acquiring HIV during pregnancy need risk reduction strategies to protect     themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as     pre-exposure prophylaxis in this population is crucial to understanding whether and how this     novel prevention strategy should be incorporated into HIV-risk reduction packages for at-     risk women planning or with pregnancy.   "
8872|NCT03169777|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with recurrent and metastatic CRC.   "
6977|NCT03194555|"     While many individuals are able to limit therapy to treatment of migraine attacks, others     need medication to reduce the frequency and/or severity of attacks. Patients with prolonged     or severe attacks leading to substantial disability, or patients who are refractory to     abortive treatments can benefit from migraine prevention.      The investigational product is a combination of two re-purposed marketed drugs used for     migraine prevention through the discovery of biologically and clinically relevant affinity     for new targets. Both drugs are being re-purposed at a significantly lower dosage compared to     the approved marketed indications dosage.      The combination is a First-in-Class drug due its new and unique mechanism of action.      The investigators propose that in predisposed individuals, migraine attacks occur due to     exuberant innate immune system activation nearby the trigeminal nerve and other cranial     nerves. The innate immunity activation leads to release of pro-inflammatory cytokines [nitric     oxide (NO), tumor necrosis factor-α (TNF-α), and reactive oxygen species (ROS)], and to COX-2     activation, which produces neuro-inflammation, causing pain and various migraine-associated     symptoms.      ALLOD-2 reverses the neuro-inflammation through dual action, inhibition of the release of the     pro-inflammatory cytokines and inhibition of the COX-2 activation. Efficacy of this product     for migraine headache pain and for migraine-associated symptoms, especially nausea (which is     refractory to other known migraine treatments), may suggest the product addresses the root     cause of migraine.   "
6978|NCT03194542|"     This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of     luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without     RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period     (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension     Phase), followed by a Posttreatment Follow-up Period.   "
6979|NCT03194529|"     The goal of this study is to evaluate the safety of Fecal Microbiota Transplantation (FMT) in     children with Crohn's disease who are in remission. Safety will be the primary endpoint and     Pediatric Crohn's Disease. Pediatric Crohn's Disease Activity Index (PCDAI) with other     secondary endpoints including changes in gut microbial diversity will also be studied. All     children will receive the equivalent of 50g of stools from a healthy donor into the jejunum     through upper endoscopy. Also, 1-2 additional mucosal biopsies will be collected during     patient's routine (standard of care) endoscopy. Subjects will have a total of 5 study visits     within 24 weeks including phone call follow up on Day 7 after FMT.   "
6980|NCT03194516|"     Men with indolent forms of prostate cancer are managed expectantly using active surveillance,     with a goal of delaying treatment and its deleterious side effects. However, almost 50% of     men experience progression with this approach and require treatment. Elevated body mass index     (BMI) is associated with a dramatically increased risk of progression to higher grade     prostate cancer. The goal of the proposed research is to gather preliminary data evaluating     the effects of a promising dietary strategy to delay cancer progression in overweight and     obese prostate cancer patients undergoing active surveillance. The investigators hypothesize     that a ketogenic diet intervention may reduce BMI and favorably alter the prostate     microenvironment.   "
6981|NCT03194503|"     The purpose of the study is to determine the efficacy of video coaching training for     neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.   "
6982|NCT03194490|"     The purpose of this study is to assess the benefit of adding stretching exercises to cervical     mobilization and cervical range of motion exercises on cervical range of motion, pain, pain     threshold, level of disability and patient satisfaction for patient with non-specific     mechanical neck pain   "
6983|NCT03194477|"     Project Narrative This 3-city proposal seeks to address HIV disparities among young (ages     15-24) Black men who have sex with men (YBMSM) in a multilevel intervention to identify,     engage and retain, high-risk HIV-uninfected and HIV-infected urban YBMSM in the HIV     prevention and treatment cascade. The mobile-enhanced engagement intervention (MEI) is driven     by the expressed and self-determined needs of each HIV infected and uninfected participant     and includes care navigation, engagement, treatment and adherence. MEI also includes a     supplemental Screening, Brief Intervention, and Referral for Treatment (SBIRT), to support     YBMSM who face barriers accessing substance use treatment. By building upon existing case     management services and flexibility to be adapted across ages and maturity and for prevention     services, this intervention has the ability to transform networks, HIV and prevention care in     YBMSM in cities with very high primary and secondary HIV transmission.   "
7101|NCT03192969|"     To investigate the safety and efficacy of abatacept with steroid treatment in comparison to     steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of     Giant Cell Arteritis in adults.   "
34794|NCT02830321|"     The purpose of this study to explore the association between Hyperemesis Gravidarum in     pregnant women and Helicobacter pylori infection.   "
6984|NCT03194464|"     This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue)     with the less involved, or so-called non-paretic hand, in people who have experienced a     stroke. In previous work the investigators found that non-paretic hand exercise to     task-failure increased excitability of the motor cortex in the more involved hemisphere and     produced behavioral improvements in the unexercised paretic hand. Importantly, the magnitude     of increased brain excitability is greater than what has been observed following brain     stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial     direct current stimulation (tDCS) and lasts longer. This approach could be implemented in the     clinical setting and could be accessible to a greater number of people than brain     stimulation. The investigators' goals in the current study are to: repeat previous findings     in a different group of participants and investigate the neural mechanisms that produce brain     and behavioral facilitation in order to inform development of this approach for clinical     implementation.   "
6985|NCT03194451|"     The main limitation in bone regeneration is the lack of vascularization of the newly shaped     tissue. The main objective of this project is to check if the simultaneous differentiation of     dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a     new pre-vascularized tissue engineered bone construct.      We will then evaluate the boosting effect of the conditionned medium on cell differentiation     and production of a prevascularized bone construct.   "
7023|NCT03193957|"     A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects     with Rheumatoid Arthritis.   "
6986|NCT03194438|"     The primary goal of this study is to determine the feasibility and acceptability of a 6-week     multicomponent integrative therapy program, Urban Zen Integrative Therapy (UZIT), for adults     with chronic, life-limiting cardiopulmonary disease. The secondary goal is to determine     preliminary efficacy of UZIT in symptom management. Pulmonary hypertension (PH) presents an     excellent model of a severe, life-limiting cardiopulmonary condition with high symptom burden     and poor outcomes suitable for this scientific inquiry. Despite medical and pharmacological     advances in the treatment, 50-55% of persons with PH will die within three years after     diagnosis. Medical management often involves life-long complex pharmacological treatment     requiring high levels of skill, knowledge, and social support. Clusters of bothersome     symptoms such as chest pain, anxiety, insomnia, dyspnea, and fatigue can overwhelm patients'     ability to manage daily activities and medication treatment regimens. Side effects of     treatment induce additional noxious symptoms. The high prevalence of physical symptoms,     depression, and anxiety among adults with PH confirmed in our prior work, can also lead to     reduced (HRQoL). A literature search found no published report of complementary, integrative     therapy interventions to alleviate symptoms in adults with PH. This study will use a single     group repeated-measures design to address the feasibility and acceptability of the     intervention and to explore preliminary efficacy.   "
6987|NCT03194425|"     Retrospective case-control study.      A substantial number of patients do not respond favourably to sacral neurostimulation (SNS)     although clinically, they appear to have the same lower urinary tract dysfunction     characteristics as the ones with good responses. This may be due to methodological issues     (lead position) or patient selection. The purpose of this study is to improve and standardize     lead position, in order to increase the patient response to test stimulation and to SNS     treatment, and to decrease adverse events.      This study consist out of two parts. In this first part, we will measure the pelvic floor     electromyography (EMG) template in 15 patients with overactive bladder (OAB) and 15 patients     with urinary retention already on SNM treatment with a >90% improvement (perfect responders)     compared to baseline. Likewise, measurements will be done in 15 OAB patients and 15 urinary     retention patients that have <50% response upon sacral neuromodulation (loss of efficacy).     The pelvic floor EMG will be measured by an intravaginal (women) or intra-anal (men) probe     that measures independently left, right, anterior and posterior part. Based upon the     differences in EMG activity between perfect-responders and non-responders, the pattern for     optimal stimulation will be determined which will be used as template for lead placement in     patients that present for test stimulation with the tined lead.   "
6988|NCT03194412|"     This intervention study is a part of the FOCUS (Frailty Management Optimization Through EIP     AHA Commitments and Utilization of Stakeholders Input) project which purpose is to critically     reduce the burden of frailty in Europe by assisting those partners within the European     Innovation Partnership for Active Healthy Ageing (EIPAHA) with commitments focusing on early     diagnosis/ screening and/or management of frailty to achieve scalability.      FOCUS aims to critically reduce the burden of frailty in Europe by developing methodologies     and tools to assist entities focusing on early diagnosis, screening and management of frailty     to achieve scalability. Frailty is a common clinical syndrome in older adults that brings an     increased risk for poor health outcomes including falls, incident disability, hospitalization     and mortality.      The FOCUS Consortium brings together a multidisciplinary team of specialists from 10     organizations in 6 countries - Italy, Poland, Portugal, Spain, Netherlands, United Kingdom -     that will work on developing, piloting and disseminating methodologies and tools to assist     entities focusing on early diagnosis, screening and management of frailty to achieve     scalability.      Wroclaw Medical University actively participates in all projects for the advances in science,     entrepreneurship, technological innovation, both with public authorities, local governments,     and enterprises. In FOCUS project, WMU is responsible for Evaluation of the project and     collaborates with the others partners in Coordination of the project, Dissemination of the     project, Synthesis of learning and realities of practice, Analysis and guidelines     development, Creation of Network and Platform for knowledge exchange, Test of guidelines in a     set of commitments (Work Package 7 - WP7).      The outcomes of this proposal will offer significant potential improvements for innovative,     coordinated and comprehensive community based prevention with regard to the optimisation of     functional capacity tools to address pre-frailty, and for improving the management of     frailty.      The registered study has its own protocol developed by Wroclaw Medical University research     team and will be implemented within WP7 of the FOCUS project.   "
6989|NCT03194399|"     In order to develop effective personalized healthcare service program for breast cancer     rehabilitation, we designed this study using mobile phone and clinical intervention(feedback     coaching).   "
6990|NCT03194386|"     Millions people, all over the world, are admitted in the Emergency Department after a trauma     or simply to receive medical cares. In France, it represents 10 million patients. Probably     because of stress associated with the event, 20% will suffer a combination of non-specifics     symptoms which persist for many months and with daily life quality impairment. The     investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization     and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of     these symptoms   "
6991|NCT03194373|"     The purpose of this study is to test the effectiveness (how well the drug works), safety, and     tolerability of the investigational drug combination of palbociclib (Ibrance) plus     carboplatin in patients with metastatic head and neck squamous cell cancer.   "
6992|NCT03194360|"     Delirium is one of main adverse events in ventilated patients who receive long-term usage of     mono-sedative. Sequential sedation may reduce these adverse effects. This study aimed to     evaluate incidence and risk factors for delirium in sequential sedation patients.   "
6994|NCT03194334|"     Balanced vegetarian diets are popular and contain health-promoting characteristics. A     balanced lacto-ovo-vegetarian diet differs in nutrient intake from an omnivorous diet, e.g.     by increased intake of fibre, magnesium and antioxidants, but lower intake of omega-3 fatty     acids and vitamin B12. However, the impact of reduced to near absent intake of carnitine,     carnosine and creatine in a vegetarian diet is less well established and could be relevant in     relation to muscle function, exercise capacity and sports performance. Few longitudinal     intervention studies investigating the effect of a vegetarian diet on the availability of     these compounds currently exist.      This study aimed therefore to investigate the effect of of transiently switching omnivores     onto a vegetarian diet for 6 months on muscle and plasma creatine, carnitine and carnosine     homeostasis.      We hypothesized that homeostasis of creatine and carnosine would be disrupted when their     dietary intake was missing. For carnitine, however, we hypothesized that homeostasis can be     maintained given its slow turnover rate and its presence in some non-meat nutrients. A second     aim was to investigate whether supplementation of creatine and beta-alanine (the     rate-limiting precursor of carnosine synthesis), concurrently with a lacto-ovo-vegetarian     diet, was able to correct for potentially emerging deficiencies.   "
25004|NCT02958397|"     The overall purpose of this study is to explore the therapeutic effect of CD33-targeted     chimeric antigen receptor T(CAR-T) cells in the treatment of Myeloid Malignancies.   "
6997|NCT03194295|"     Efforts to improve methadone maintenance outcomes are often thwarted by strong social     networks that reinforce substance use and other risk behaviors. The proposed study the     feasibility and preliminary efficacy of a practical community support intervention that     employs an alteration model of social network change. The intervention works with patients     and at least one drug-free family or friend to support participation in community activities     designed to mobilize recovery support and expand personal drug-free social networks.   "
6998|NCT03194282|"     Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss     balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift     body weight or to with stand external pertubations. An important determinant of activities of     daily living performance is standing balance. Therefore, poor balance, or postural stability,     is significant predictors the risk of fall. After a fall, the patient can experience     psychological, physical, social, economic, and sometimes fatal effects. The injuries can     reduce the patient's mobility as well as independence and influence quality of life. Postural     movement patterns include three discrete control strategies: hip, knee, and ankle strategy.     The ankle rocker is an important factor to maintain balance during standing and the ankle     strategy restores the center of mass (CoM) to a position of stability through body movement.     As a result, effective control of foot motion and ankle stability may decrease postural sway     and the risk of fall in chronic stroke.      The purpose of this study is to investigate the effects of the insole on balance capacity in     chronic stroke.   "
6999|NCT03194269|"     This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the     long-term safety and performance of EARFOLD® Implantable Clip System.   "
7000|NCT03194256|"     This study is designed to examine how the nicotine content of cigarettes and the nicotine     concentration and flavors in e-liquids influence responses to and use of these products in     adolescent smokers. Participants will complete a total of six sessions (an in-person     screening/baseline session and five lab sessions.   "
7001|NCT03194243|"     This is an observational prospective multicenter study of patients admitted for acute dyspnea     in an emergency department of the participating centers in the Lorraine district.      The primary objective is to assess the outcome of this population according to the cause of     acute dyspnea as well as identify the predictors of this outcome, both overall and according     to each acute dyspnea cause.   "
7002|NCT03194230|"     The purpose of this study is to evaluate whether the use of cervical dilators for cervical     ripening in case of second trimester medical termination of pregnancy (TOP) is effective to     reduce duration of labor.   "
7003|NCT03194217|"     This phase 2b study is designed as multicentre, multinational, randomized, double blind,     parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in     subjects with excessive daytime sleepiness with Parkinson's disease.   "
7004|NCT03194204|"     Rheumatoid Arthritis (RA) is a chronic inflammatory disease characterized by joint swelling,     joint tenderness and destruction of synovial joints, leading to severe disability and     premature mortality.   "
7005|NCT03194191|"     Acupuncture is widely used for treatment of insomnia. The research hypothesis is that     acupuncture may be more effective than sham acupuncture to treat insomnia during pregnancy.      GAS is a randomized controlled trial with placebo acupuncture using the insomnia severity     index (ISI) as the main outcome criterion.   "
7006|NCT03194178|"     The study team has made the hypothesis that the intensity of the phonatory disorders     (rhinolalia), and of the maxillo-mandibular growth anomalies (facial morphology), may have     negative effects on the quality of life of adolescents with Pierre Robin sequence.      The investigators also want to assess the impact of 2 different surgical protocols of closure     of the cleft palate (1 or 2 step(s)), on the current phonatory and morphology aspects. These     2 protocols were performed, by 2 parisian clinical teams, that have now been merged at Necker     hospital.   "
7129|NCT03192592|"     Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant,     anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and     complications.   "
7130|NCT03192579|"     This study aim to evaluate whether intensive lipid lowering therapy may improve the clinical     outcomes in coronary artery disease patients with in-stent neoatherosclerosis, in comparison     with standard therapy.   "
7007|NCT03194165|"     The purpose of this study is to develop population pharmacokinetic models for antiretroviral     drugs in a pediatric population.      The interest of these models is multiple :        -  describe the pharmacokinetics of these drugs in children and explain the          inter-individual variability of concentrations through covariates such as weight, age,          sex, smoking status, co-treatments and bilirubin;        -  estimate maximum, minimum and exposure concentrations from the individual          pharmacokinetic parameters for each patient;        -  propose adaptations of doses for certain classes of children (according to age, weight          etc.) and individualize the doses.   "
7008|NCT03194152|"     This is a 2 parallel-arm randomized controlled study with free-living subjects on     self-selected diets. The objective of this study is to compare the effects of two servings of     peanuts with an isocaloric matched refined carbohydrate snack food on glucose, lipids and     lipoproteins and cardiovascular health risk factors, satiety and gut microbiota in 250     Chinese participants at risk for metabolic syndrome (overweight/obese, enlarged waist     circumference, elevated LDL-cholesterol, prehypertension, and/or prediabetes).      The investigators hypothesize that the inclusion of 2 serving of peanuts in the diet will     decrease blood glucose, LDL-cholesterol, and improve satiety sanctification between meals and     gut microbiota compared to the control group and baseline.   "
7037|NCT03193775|"     -  HBV is not curable with persistent HBsAg even after the disappearance of HBV DNA.        -  HBsAg > 1000 IU/ml is associated with the risk of virological recurrence and HCC.        -  There is an impaired immune response to HBsAg and HBV vaccine is an easily available,          cost-effective, non-harmful method of stimulating immunity.   "
7038|NCT03193762|"     Today, there is no simple tool for measuring patient anxiety. The primary purpose of this     study is to evaluate the ability of the Visual Analogue Scale (VAS) to measure anxiety in     painful hospitalized patients, and to correlate it to STAI-Ya and HAD-7A auto questionnaires.   "
25005|NCT02958384|"     The overall purpose of this study is to explore the therapeutic effect of LeY-targeted     chimeric antigen receptor T(CAR-T) cells in the treatment of myeloid malignancies.   "
7009|NCT03194139|"     The study will be a double-blind, randomized, crossover, single-dose assessment of     IV-administered GC4711 compared to GC4419 in healthy volunteers.      Consenting subjects will undergo screening procedures within 28 days of the start of dosing.     Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine     from all subjects.      Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will     receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety     review by the Galera study team , if no safety concerns are identified after the last subject     completes study participation, enrollment will continue in 2 stages to a crossover study     design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are     identified in stage 1 following a clinical safety review by the Galera study team, 20     subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover     design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) ->     Ref (GC4419) or Ref (GC4419) -> Test (GC4711). On Day 1, subjects will receive the first     treatment they were randomized to, and on Day 4 (following a washout), they will receive the     second treatment. Subjects will be followed up for 2 days after the second treatment.   "
7010|NCT03194126|"     Reducing the time patients spend in the labor and delivery room saves money and reduces     patient discomfort as well and reducing complications. We will compare two methods for     inducing cervical maturation in order to shorten the time taken between administration of     drugs and delivery.   "
7011|NCT03194113|"     The aim of this project is to investigate the effectiveness of phase-based trauma-focused     therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD     related to childhood abuse.      We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or     i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and     after a 6 and 12 months follow-up in an intention-to-treat analysis.   "
7012|NCT03194100|"     The investigators measured serum METRNL levels in newly diagnosed patients with type 2     diabetes (T2DM) compared with normal glucose tolerance or prediabetes and explored the     correlations between its serum levels and various metabolic parameters   "
7013|NCT03194087|"     Results from KDOQI guidelines, parathyroid hormone (PTH) level within target range is     150-300pg/ml. Both lower PTH levels and higher PTH levels were associated with higher risk of     all-cause mortality. However, in out of target range, it is still unknown which mortality     higher. so, in this prospective, observational clinical trial study. the investigators will     observe the mortality and cardiovascular incidence rate between SHPT(>800pg/ml) and low serum     PTH levels(<60pg/ml). Both two groups of patients will receive a reasonable treatment     according to the suggestions in K/DOQI guidelines.   "
7014|NCT03194074|"     Postoperative cognitive impairment is one of the most common complications in elderly     surgical patients. Laser laryngeal surgery is a short procedure, but characterized by high     risk of disastrous airway fire. So the recommended oxygen concentration is less than 30%. For     elderly patients, because of preoperatively declined cardiovascular and lung function and     cognitive function, there is a potential that intraoperative low oxygen concentration may     lead to drop of arterial oxygen tension, decrease of brain oxygenation, and exacerbate brain     function impairment. Intravenous anesthesia and inhalation anesthesia is two commonly used     technique for general anesthesia. Consequently, we carry out this study to identify whether     different classes of anesthetics can affect postoperative cognitive function in old patient     undergoing laser laryngeal surgery.   "
7015|NCT03194061|"     The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy     and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a     high volume brazilian center.   "
7016|NCT03194048|"     This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and     drooling in children with cerebral palsy.   "
7017|NCT03194035|"     The aim of this study is to study the per and post-exertional variations of the pro and anti     inflammatory markers during an ultra-endurance race in healthy volunteers.   "
7018|NCT03194022|"     The aim is to study per and post-exertion variations of biological markers during an     ultra-endurance race   "
7019|NCT03194009|"     The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and     cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult     subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will     receive as intervention, metformin and lifestyle modification therapy and the other half will     receive only lifestyle modification therapy.   "
7020|NCT03193996|"     The study seeks to determine whether the 4DCT imaging technique can be used to replace     current invasive diagnostic tests for ligament injuries of the wrist.   "
7131|NCT03192566|"     Although there are numerous studies investigating the pharmacokinetic properties of     intravenous acetaminophen in infants and children with normal weight, there are none in the     obese pediatric patient . This study will investigate the pharmacokinetics and     pharmacodynamics of acetaminophen (total Cl and Vd) in obese children and adolescents   "
7021|NCT03193983|"     Fingertip is a complex structure that is responsible for the fine function of the fingers and     the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the     insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious     condition that if untreated properly could lead to significant functional disability and     disuse of the injured finger. Up to date, defining the best treatment option for this injury     remains controversial. Hand surgeons are divided between proponents of flap coverage and     conservative treatment, driven by beliefs, training programs and financial aspects. After     recently reviewing the literature for the current best evidence and fundamentals of     conservative treatment, Krauss and Lalandei in their recent review of the literature, pointed     out to the necessity for implementing controlled trials to compare both ways of treatment.   "
7022|NCT03193970|"     The intent of this study is to establish a registry of post‐surgical outcomes in patients     undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating     institutions. The goals of this initiative are to obtain a detailed baseline of multiple     patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various     presenting conditions associated with them, so that future quality improvement interventions     can be evaluated accurately as to their relative contribution to improved outcomes.   "
7024|NCT03193944|"     General objective: To assess the effect of vitamin D supplementation on metabolic syndrome     among older adults in Karaj city, Alborz province in Iran. A two-arm randomised controlled     trial (RCT) will be conducted by recruiting participants. Inclusion Criteria: Food insecure,     metabolic syndrome; Vitamin D deficiency Exclusion Criteria: those who are already taking any     type of vitamin D supplements, Individuals with a history of allergy, Those subjects with     serious medical condition such as cancer, heart attack, stroke, and etc., Intervention group:     The intervention will start from 10 of May 2017 to 11 of July 2017 for 2 months. The     intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8     weeks plus pamphlets and brochures about nutrition and health at the beginning of the study.     Control group: The respondents in control group will receive placebo plus brochures and     pamphlets related to nutrition and health at the beginning of the study. The data collection     process will identify the older adults for both groups; intervention and control. Consent     will be obtained from those who are eligible. Anthropometric measurement (height, weight,     body mass index, and waist circumference), blood pressure measurement, blood taking and     three-day food record will be obtained during baseline from all study respondents in the     intervention and control groups. Primary Output: Achieving 25 (OH) D upper than insufficient     serum 25(OH) D level >30 ng/l. Secondary Output: Reduction anthropometry (body mass index     (BMI) and waist circumference (WC), Improved Biomarkers indicators (lipid profile, fasting     blood fast), improved blood pressure before and after intervention.   "
7025|NCT03193931|"     The study is designed as an open-label, randomized, prospective, multicenter, phase II study     comparing pembrolizumab with methotrexate in elderly, frail or cisplatin-ineligible patients     with squamous carcinoma of the head and neck (HNSCC)   "
7026|NCT03193918|"     This is a single-arm phase I/Ib study of crenolanib combined with ramucirumab/paclitaxel as     second line therapy for patients with advanced/metastatic adenocarcinoma of the esophagus,     GEJ or stomach. Patients will be enrolled in two phases; dose escalation phase and dose     expansion phase.   "
7027|NCT03193905|"     Background      Major spinal surgery tend to be lengthy with an increased risk of hypothermia. A quality     improvement project of patients undergoing major spinal surgery showed that 67 % were     hypothermic at the beginning of surgery. Several patients expressed a feeling of coldness at     the arrival of the operating theatre.      Aim      To evaluate if Bairhuggers Full Access Underbody blanket can prevent hypothermia at     initiation if used as prewarming and intraoperative warming compared to the results from the     local quality improvement project. In addition we aim to explore patients´ experiences of     comfort in relation to their temperature.      Method      Temperature of patients undergoing major spinal surgery (n=30) will be assessed at arrival to     the theatre, after insertion of bladder catheter, at the start and end of surgery using a     bladder temperature. The patients´ experiences of comfort will be evaluated with a 5 point     Likert at the arrival to the operating theatre and after ten minutes of active prewarming     with Bairhuggers Full Access Underbody blanket. Preoperatively ten randomly chosen patients     will be observed and later interviewed in order to obtain further information regarding their     experiences of comfort in relation to their temperature.      Conclusion and perspectives      By increasing the investigators knowledge on Bairhuggers Full Access Underbody blanket and     its effects in preventing hypothermia as well as gaining insight to patients´ experiences of     comfort in relation to temperature, the investigators anticipate to improve pre-anesthetic     care and minimize risk factors associated with hypothermia for patients undergoing major     spinal surgery.   "
7028|NCT03193892|"     Pulmonary lymphangioleiomyomatosis (LAM), a disease characterized by diffuse cystic changes     in the lung, is a rare disorder that affects almost exclusively women. The main objectives of     this study are to accurately evaluate the prevalence of LAM, the status of disease, the     diagnosis and treatment, the quality of care, and the health related outcomes in China.   "
7029|NCT03193879|"     Particulate matter(PM) exposure has been shown to increase the morbidity and mobility of a     variety of respiratory diseases, including COPD and asthma. This study focus on the effects     of PM on the pulmonary function and acute exacerbation of COPD and asthma patients in China,     where PM exposure is much heavier than the United States and European countries.   "
7030|NCT03193866|"     The overarching goal of this study is to determine whether rituximab (RTX) offers     effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs     (DMT) in the largest real-world population-based structured prospective follow-up cohort of     Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment     naïve patients starting their first DMT and patients switching from a previous first line DMT     (escalation/second-line).   "
7031|NCT03193853|"     This study evaluates efficacy of TAK- 228 and TAK- 117 followed by cisplatin and nab     paclitaxel in patients with metastatic triple negative breast cancer.   "
7032|NCT03193840|"     Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The     outcome was reviewed to assess the feasibility of the surgical procedure.   "
7033|NCT03193827|"     The aim of this study is to demonstrate the efficacy of in-line filtration in reducing the     incidence of postoperative phlebitis associated with peripheral short-term vascular access.      In this controlled trial, 268 surgical patients are 1:1 randomised to in-line filtration     (study group) and standard care (control group). The incidence of phlebitis (defined as     Visual Infusion Phlebitis, VIP score≥2) within 48hrs postoperatively is compared between the     two groups, as well as the onset and severity of phlebitis and the reasons for removal of the     cannula. The lifespan of venous cannulae and cost-of-care are compared for the study and     control groups through a Kaplan-Meier curve. Multivariate Cox regression analysis is     performed to evaluate the effect of in-line filtration on risk of phlebitis and cannula     removal.   "
7034|NCT03193814|"     The purpose of this study is to evaluate the efficacy and safety of apatinib in combination     with second-line FOLFOX or FOLFIRI for metastatic colorectal cancer in patients with disease     progression during or after first-line therapy.   "
7035|NCT03193801|"     To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,     California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.   "
7036|NCT03193788|"     This study aims to verify superiority of pemetrexed maintenance to observation for patient     without disease progression after 1 st line cisplatin-based chemotherapy.   "
7039|NCT03193749|"     Purpose:      The ATTACH trial, as currently designed, will primarily test whether a treatment with     Amiodarone for at least 6 months has a trypanocidal effect among individuals with     mild-to-moderate Chronic Chagas Cardiomyopathy. A secondary goal will be to confirm, in this     population, a clinical benefit from this treatment (in terms of reducing mortality or cardiac     arrhythmic events), and to explore whether a potential trypanocidal effect is associated with     a clinical benefit.   "
7040|NCT03193736|"     The study will evaluate the efficacy and safety of the implant and IOP lowering effects with     or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the     patient will be asked to perform several examinations up to 24 months after surgery.      The primary efficacy objective of the present study is to show the IOP reduction under     medication 6 months after surgery compared to medicated diurnal IOP at screening.   "
7041|NCT03193723|"     The aim of this study is to evaluate success, efficacy, feasibility and safety of a simple     five step ultrasound guided local anesthetic infiltration technique for unilateral open     inguinal hernia repair and to determine the non-inferiority of the block to spinal anesthesia     by comparing intraoperative and postoperative complications, pain control and patient and     surgeon satisfaction of the block with spinal anesthesia.   "
7042|NCT03193710|"     The body immunity is important to the development of tumor. The immune system is in charge of     monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response     and affect the elimination of tumor cells. The purpose of the trial is to test whether     inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing     colorectal cancer resection through depression of lymphocytes-mediated immunity.   "
7043|NCT03193697|"     This trial explores the application of different hip replacement materials in elderly     patients with unstable intertrochanteric fracture, and aims to provide the experience and     basis for hip arthroplasty in elderly osteoporosis patients with unstable intertrochanteric     fracture.   "
7044|NCT03193684|"     the aim of this study is to examine the role of autonomic nervous system in the increase in     hepatic glucose production in response to glucosuria caused by inhibition of renal glucose     uptake   "
7045|NCT03193671|"     This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal     population in the western region of Sweden. The aim is to improve diagnosis of ovarian     cancer.      If the investigators observe a clear improvement in the early diagnosis of EOC, the     investigators aim to implement the best strategy for all patients with suspected pelvic tumor     mass in the western region of Sweden.   "
7046|NCT03193658|"     The study aims to evaluate the effect of US guided bilateral Thoracolumbar Interfascial plane     (TLIP) block performed at the level of the lumbar spine surgery (involving 1 up to 3 adjacent     lumbar vertebrae) after induction of general anesthesia and before starting the surgery on     postoperative opioid consumption by the patients during the first 24 hours postoperative.   "
7047|NCT03193645|"     The DUO study's main objective is to evaluate, in the real life, the prevalence of     cardiovascular risk in patients with prostate cancer that hormone treatment of androgen     suppression by Degarelix was introduced.      This study will also assess, at the initiation of therapy, the prevalence of osteoporosis,     metabolic comorbidities, depression, sexual and geriatric patients suffering from prostate     cancer.   "
7048|NCT03193632|"     The study aims to correlate Lean Body Mass (LBM) Evaluated by Musculoskeletal Ultrasound with     Resting Energy Expenditure (REE) measured by Indirect Calorimetry and to generate a     predictive equation of REE based on LBM, in addition to identifying other factors that may     affect REE such as age, gender, and severity scores.   "
7049|NCT03193619|"     The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused     Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical     application.   "
7061|NCT03193463|"     The purpose of this study is to determine if treatment with topotecan by an alternative     method, direct delivery into brain tumors, is safe and well tolerated. The Cleveland     Multiport Catheter is a new, investigational device that will be used to deliver topotecan     into your brain tumor. A second purpose of this study is to determine whether the Cleveland     Multiport Catheter can be used effectively and safely to deliver topotecan into your brain     tumor.      This study will also determine the best dose of topotecan to deliver to your tumor with use     of the Cleveland Multiport Catheter and will also examine how your tumor responds to     treatment with topotecan.   "
7050|NCT03193606|"     eligible teeth will be randomly divided into two groups to be treated with incomplete caries     excavation (A), where (A1) represents teeth to be treated with application of Nano silver     fluoride solution on remaining carious dentin prior to final permanent glass ionomer     restoration application, (A2) represents comparator group to be restored without Nano silver     fluoride application prior to restoration. Every participant will receive both the     intervention and control treatment. Image of radiographic density of remaining carious dentin     will be evaluated using PSP plate at baseline immediately after restoration and after 6     months after restorative procedures.      The null hypothesis tested is that application of Nano silver fluoride solution prior to     glass ionomer restoration will not increase radiopacity of the underlying dentin treated by     incomplete carious removal technique compared to that of direct glass ionomer restoration     without prior application of Nano silver fluoride.   "
7051|NCT03193593|"     To determine the safety and efficacy of single intra-operative treatment of EB-001 IM     injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with     subpectoral implants   "
7065|NCT03193411|"     this is an interventional prospective clinical study which was conducted to evaluate the     efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of     Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate     myopia.   "
7066|NCT03193398|"     This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of     up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.   "
7176|NCT03191929|"     This study assessed the potential of Health Information Technology (HIT) to improve the     screening, diagnosis, and treatment of depression and post-traumatic stress among LEP     Southeast Asians. Should this intervention be found to be effective, the principles of the     HIT technology could be easily adapted for screening in other languages to increase the     recognition and treatment of depression and PTSD in primary care settings.   "
7052|NCT03193580|"     Non-invasive brain stimulation can both study and potentially treat neurological disorders.     Transcranial direct-current stimulation (tDCS) is an emerging safe and tolerability form of     stimulation and has been used increasingly over the last decade.      The purpose of this research is to see if two different types of tDCS can improve motor     function in healthy children. tDCS has been shown to safely enhance hand motor function in     healthy adults, and those that have suffered stroke and other conditions. Recently the     investigators demonstrated that tDCS may enhance hand motor function in healthy children,     however, how it does so is unknown. In addition to assessing changes in motor function when     tDCS is given during motor skill training, the investigators will perform various tests     before and after stimulation to understand the changes that happen in the brain accompanying     motor skill learning and brain stimulation.      The investigators hypothesize that there will be an accelerated acquisition of motor skill,     when training is paired with conventional anodal tDCS, HD-tDCS, or sham tDCS.   "
7053|NCT03193567|"     The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient     Killing Cell Therapy for refractory and advanced non-small cell lung cancer   "
7054|NCT03193554|"     Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic     blood pressure 140mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or     greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . The disorder     usually occurs after 20 weeks of pregnancy and worsens over time. Risk factors for     pre-eclampsia include: obesity, prior hypertension, older age, and diabetes mellitus,     primigravida and pregnant women with multiple gestation .      Healthy women pregnancy can be associated with resistance to the action of insulin on glucose     uptake and utilization. Insulin Resistance (IR) is defined as decreased ability of target     tissues such as liver, adipose tissue and muscle to respond to normal circulating     concentrations of insulin. Insulin Resistance can be a result of a number of factors such as     defective molecular structure of insulin, defective receptor functioning or defective signal     transduction pathway .      Preeclampsia is associated with increased expression of Tumor necrosis Factor α and other     inflammatory marker which causes Insulin Resistance. Increased Insulin Resistance leads to     dyslipidemia that can worsen the placental ischemia leading to vicious cycle of     ischemia-inflammation-Insulin Resistance-dyslipidemia-ischemia . Insulin resistance has also     been hypothesized to contribute to the pathophysiology of preeclampsia. Compared to women who     have normotensive pregnancies, women who develop preeclampsia are more insulin resistant     prior to pregnancy .      The recognition that specific miRNAs are induced by hypoxia and are commonly dysregulated in     preeclampsia raises the possibility that such miRNAs mediate the adverse effects of placental     hypoxia in preeclampsia. MiRNAs present in maternal blood may have the potential to be used     as biomarkers, as they are relatively stable and tissue specific . It was found that mir-210     is induced in patients with pre-eclampsia, whether mir-210 contributes to the pathogenesis of     pre-eclampsia, a complex disorder widely believed to be associated with placental hypoxia .   "
7055|NCT03193541|"     To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA     assay directed at a BCa-associated diagnostic signature in voided urine samples of patients     with microscopic hematuria.   "
7056|NCT03193528|"     To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA     assay directed at a BCa-associated diagnostic signature in voided urine samples of patients     with gross hematuria.   "
7057|NCT03193515|"     Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder     cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa     when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much     better. Because of this severe limitation, all patients who are under surveillance to monitor     for recurrent BCa must undergo an invasive examination of the urinary bladder, where a     miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We     propose to improve the non-invasive detection of recurrent BCa by further validating a     multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine     samples.   "
7058|NCT03193502|"     -Rivaroxaban is factor Xa inhibitor   "
7059|NCT03193489|"     Individualization of exercise is recommended but rarely performed in patients with     Parkinson's disease (PD).      Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The     clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment,     treated patients and the control group were subjected to a two-year observation.      Objectives: The effect of the unusually highly intense and strictly individualized sensomotor     and visuomotor agility program was determined for the clinical symptoms, mobility and     stability of non-demented PD patients with a two-year follow-up. Detection and comparison of     results of patients undergoing biphasic maintenance with the results of intensively treated     patients and the control group.      Patients were recalled every 3 months after the first intensive examination and one year     after a one-year control. The results of the active group were continuously compared with the     results of the passive and control groups, thus determining the effectiveness of our     treatment and the deterioration of the other groups in life-quality.      The treated groups will be divided into two. One Parkinson's group takes part in a treadmill     treatment that takes place 3 times a week for 2 years. The other group does not undergo a     special series of exercises after 3 weeks of intensive therapy.      Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale,     Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD     symptoms.      In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL,     Beck Depression Score, PDQ-39, EQ5D VAS, Schwab & England Scale for Parkinson's Disease. The     TUG test and 12 static posturographic measurements are compared and compared to the healthy     group as a standard.      An at-limit and individualized sensorimotor and visuomotor agility exercise program vs.     standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility,     and postural stability by functionally meaningful margins. As a long-term solution, a     follow-up treatment can slow down the progression of clinical symtoms.   "
7060|NCT03193476|"     This is an international, multicentre, prospective, non-interventional, observational     registry of patients with X-linked hypophosphatemia (XLH). The main objective of the registry     is to collect data to characterise the treatment, progression and long-term outcomes of XLH     in both adult and paediatric settings.   "
7132|NCT03192553|"     Alternative doffing strategies may help prevent self-contamination of staff members when     using PPE. The study aims to determine which among the suggested methods in the literature     that have been proposed as alternatives to the traditional CDC recommended doffing protocol,     would be most beneficial to reduce healthcare worker self-contamination.   "
7063|NCT03193437|"     The purpose of this study is to evaluate the safety, tolerability and effectiveness of     selinexor in patients with advanced thymic epithelial tumor progressing after primary     chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage     design. The study population is adults with histologically confirmed, advanced, inoperable     TETs who are progressing after treatment with at least one platinum containing chemotherapy     regimen.      This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one     running in EU (25 patients):      There are two study arms:      Arm A: Thymoma        -  Stage 1: 15 patients        -  Stage 2: 10 patients      Arm B: Thymic carcinoma        -  Stage 1: 15 patients        -  Stage 2: 10 patients   "
7064|NCT03193424|"     Esophageal cancer is a common malignant tumor in china, occupies the second place of     malignant tumor morbidity and mortality, the overall 5-year survival rate less than 20%.   "
25336|NCT02954042|"     The purpose of this investigation is to compare the clinical benefits of using the Pelvital     product, in comparison to a sham procedure as a noninvasive treatment for female incontinence   "
7067|NCT03193385|"     Closed reduction is where the thigh bone is placed into the socket without any surgical     incision being made. This is more likely to be performed in a child under the age of four     year. The femoral head is gently manipulated into the socket, whilst the child is under     anaesthetic. Once the femoral head is in place, a hip Spica is applied and can remain in     place for up to three months to maintain the hip in the correct position. This allows time     for healing and for the socket and the thigh bone to mould together as a joint.      The purpose of this study was to identify and evaluate risk factors of avascular necrosis     (AVN) after closed treatment for developmental dysplasia of the hip (DDH).      assessed according to Salter's classification system.   "
7069|NCT03193359|"     This study is an open-label extension study to evaluate the safety, tolerability and efficacy     of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have     successfully completed the double-blind study: 1313-301-008.   "
7070|NCT03193346|"     This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared     with placebo as headache prophylaxis in Chinese participants with chronic migraine.   "
7071|NCT03193333|"     Objectives: To evaluate the non-inferiority in the intraocular pressure decrease of the     preservative-free ophthalmic solution PRO-122, manufactured by Laboratorios Sophia S.A. de     C.V., versus concomitant therapy in subjects with uncontrolled primary open-angle glaucoma     and/or IOP.      Hypothesis: The mean (average) value of the IOP final absolute reduction in the experimental     group (PRO-122) is not lower, considering a lower limit of 1 mmHg, compared to the IOP mean     absolute reduction of the standard group (concomitant therapy).      Methodology: A non-inferiority, phase III, double-blind, randomized, controlled, parallel,     clinical trial   "
7072|NCT03193320|"     This is a single-center prospective randomized control trial (RCT) to determine whether the     continuous monitoring of the plethysmographic variability index (PVI) during low-risk     surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients     that attend our day surgery unit, and who will be operated under general anesthesia, will be     randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring     group (PVI-directed). The amount of fluid infused together with the time to discharge, will     be assessed in each participant during the postoperative period along with additional     secondary outcomes.   "
7073|NCT03193307|"     The primary objective of this trial is to investigate the effect of multiple doses of     ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306     and the effect of single dose of BI 409306 on multiple dose pharmacokinetics of     ethinylestradiol / levonorgestrel (Microgynon®)   "
7074|NCT03193294|"     Angina is form of chest pain that is due to a lack of blood to the heart muscle. Angina is     commonly triggered by stress and exertion, and is a common health problem worldwide. The     diagnosis and treatment of angina is usually focused on detection of blockages in heart     arteries, and relief of this problem with drugs, stents or bypass surgery. However, about one     third of all invasive angiograms that are performed in patients with angina do not reveal any     blockages. Many of such patients may have symptoms due to narrowings in the very small micro     vessels (too small to be seen on an angiogram). The purpose of this research is to undertake     a 'proof-of-concept' clinical trial to gather information as to whether routine tests of     small vessel function in the heart might help identify patients with a stable coronary     syndrome due to a disorder of coronary function (vasospastic or microvascular angina), and     appropriately rule out this problem in patients with normal test results. The diagnostic     strategy enables stratification of patient sub-groups to optimized therapy (personalised     medicine). Evidence of patient benefits in this study would support the plan for a larger     study that would be designed to impact on healthcare costs and patient reported outcome     measures (PROMS).   "
7075|NCT03193281|"     Chronic myeloid leukaemia (CML) is due to a chromosomal abnormality in white blood cells     which results in abnormal multiplication. CML in its earlier, slower growing chronic phase     (CP) is well controlled by the tyrosine kinase inhibitor (TKI) drug imatinib, which targets     the consequences of the chromosomal abnormality, inducing a response and subsequent remission     (as measured using molecular techniques on patient blood or bone marrow samples in the lab).     Dasatinib, a newer TKI drug, similar in design to imatinib, gives a more rapid molecular     response, however the long term side-effects are less known than imatinib.      This study will investigate the efficacy and safety of a treatment plan for patients with     newly diagnosed CML-CP, where dasatinib will be used to more rapidly induce a molecular     response (MR3.0) within 12 months, after which imatinib will be used to maintain the CML in     that remission. It is hypothesised that imatinib is safe and effective in maintaining MR3.0     in patients with CML who achieve MR3.0 at 12 months following initial induction therapy with     dasatinib.   "
37404|NCT02796066|"     The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical     gel in the treatment of moderate to severe acne.   "
7076|NCT03193268|"     Determine the short-term and lasting effects of intensity-matched exercise programs on level     2-3 PD patients' clinical symptoms, postural control, and mobility.      Hypothesis        1. The inclusion of a Borg-scale/heart-rate matched active control group will allow us to          test the idea that, in addition to a fitness element, the reflexive movements that          chellenge PD patients' sensorimotor system will improve patients' clinical symptoms,          posture, and mobility more than fitness training and that such lasting effects will be          superior in the agility compared with the fitness-control group. This hypothesis emered          from the idea that the favorable results in the currently under review paper may be in          part due to a simple conditioning effect instead of a specific motor learning effect          caused by the xbox training.        2. If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance          training group will be also added to test the idea that the reflexive actions evoked by          the agility program by xbox exergaming still produce superior adaptations vs. the          balance group because xbox forces patients to rapidly and reflexively execute movements          (respond to cues, prompts), while balance training allows patients to stop, go, stop,          and go and disrupt the continous execution of linked movements. The disruptions of          movement chains could arise from small losses of balance on the unstabel surfaces, need          for patients to re-initiate every movement element of a sequence, planning each movement          element. It is not clear yet how it woul be possible to match all three intervention          groups on Borg/heart rate intensity.   "
7077|NCT03193255|"     Multipurpose solutions (MPS) are the most commonly prescribed regimen to clean, disinfect and     rinse rigid lenses. The preservatives used in MPS may cause hypersensitivity and the presence     of quaternary ammonium compounds (QAC) may increase development of antiseptic resistance     mediated by QAC resistance genes, thus lowering the efficacy of disinfection. Povidone-iodine     (PVI) has been safely used as a disinfectant for ophthalmic operations and eye drops. The     cleadew GP (Ophtecs, Japan) tested in the current study is a PVI based rigid lens     disinfecting solutions which does not employ QAC. If its efficacy and safety can be confirmed     in this study, it will be a good alternative rigid lens care regimen for children.   "
7078|NCT03193242|"     This study is an extension of a pilot study in which investigators developed and tested a     computerized tool to help physicians to determine if their patients' asthma is well     controlled, advise them on medication changes required according to the current level of     control, and automatically generate an electronic version of the AAP, all based on patient     responses to a questionnaire completed by patients on a tablet computer. In this phase     patients will have the ability to complete the questionnaire on their smartphones, through a     pre-downloaded app and will have access to an electronic asthma self-management app.   "
7079|NCT03193229|"     The overarching objective of our work is to provide an inexpensive and scalable m-health tool     to increase both volume and intensity of physical activity and reduce sedentary behavior in     patients at risk for type 2 diabetes. The objective of this study is to pilot test MapTrek, a     text-messaging based intervention.   "
7080|NCT03193216|"     This study evaluates the addition of an alginate based solution to twice daily proton pump     inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's     esophagus. The investigators hypothesize that the addition of this medication will help to     achieve complete remission of Barrett's over a shorter period of time.   "
7081|NCT03193203|"     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the     autoinjector and pre-filled syringe of SB4 in healthy male subjects.   "
7082|NCT03193190|"     A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety,     tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based     treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma     (PDAC).   "
7083|NCT03193177|"     Effectiveness of fasting or fasting-mimicking diet has been proved an effective approach to     treat metabolic and autoimmune diseases in mice. However, clinical trials performing     prolonged fasting with more than 7 days have not been reported. Investigators conduct an open     label, phase I/II clinical trial to evaluate the safety and effectiveness of the 21-day     fasting-like diet in the treatment of metabolic and autoimmune diseases.   "
7084|NCT03193164|"     The study will investigate the effects of neuromuscular electrical stimulation (NMES) in     patients with septic shock. The objective of this study will be investigate the effects of     neuromuscular electrical stimulation (NMES) in patients with septic shock.   "
7085|NCT03193151|"     INTERLIVER is a prospective observational study of the relationship of the molecular     phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical     features and outcomes. A segment of a biopsy performed as standard-of-care for indications,     or by center protocol, will be used for gene expression study.   "
7086|NCT03193138|"     Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of     prostate cancer seems to have an impact on the cardio-vascular system. This study     investigates reports of cardiovascular toxicities for treatment including Anatomical     Therapeutic Chemical (ATC) classification: sex hormones (G03), hypothalamic hormones (H01C)     and sex hormones used in treatment of neoplastic diseases (L02) in the French     pharmacovigilance database and European Clinical Trials (EudraCT) database.   "
7087|NCT03193125|"     This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral     carnitine supplementation modifies mitochondrial fatty acid processing in healthy young     adults.   "
7088|NCT03193112|"     Agomelatine is a melatonin drug used to treat depressive disorder. Agomelatine may also some     effects on ocular pressures. In this study, we aimed to demonstrate that melatonin decreases     intraocular pressures when given depressive patients.   "
7133|NCT03192540|"     This study explores the effects of an eight-week center-based exercise intervention for     adolescents with Down syndrome on home exercise compliance. As well, to observe changes in     fitness including muscular strength, endurance and aerobic capacity. Finally to observe any     changes in mood, behavior and quality of life.   "
7166|NCT03192059|"     This is a Phase II study in patients with advanced and/refractory cervical cancer,     endometrial carcinoma or uterine sarcoma.      Patients will be treated with an immunomodulatory cocktail (Vitamin D, aspirin,     Cyclophosphamide and Lansoprazole), followed by pembrolizumab, combined with radiation. In     addition, patients will take Curcumin, a food supplement.   "
7089|NCT03193099|"     WIN-HD is a monocentric longitudinal study comparing premanifest Huntingtin (HTT) mutation     carriers and non HTT mutation carriers to determine that white-matter atrophy occurs far     earlier than clinical onset in HD using Diffusion-weighted Nuclear Magnetic Resonance (N     spectroscopy (DWS) and Diffusion Tensor Imaging (DTI).      The investigators will recruit up to 20 premanifest HTT mutation carriers (15 completed) and     up to 20 non HTT mutation carriers (15 completed). It is important to have those 2     populations in order to compare our results and determine if there are significant     white-matter changes far from the onset of HD. Therefore, non HTT mutation carriers will be     age and gender matched to premanifest HTT mutation carriers.      In order to test the hypothesis, the study has 2 visits with a year interval.      This study is based on 4 principal criteria:        1. Imaging criteria        2. Clinical and neurological criteria        3. Psychological criteria        4. Behavioral criteria   "
7115|NCT03192787|"     The purpose of this study is get to know what and how Sanwujiaowan capsule in hospital     results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring     as registration research.   "
7116|NCT03192774|"     A single center registry including all patients treated with TAVI at the Heart Center, Bad     Segeberg, Germany   "
7177|NCT03191916|"     The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral     prefrontal cortex (LDLPFC) will induce long-lasting effects in improving cognitive function     and reducing cognitive fatigue and fatigability in PD patients with MCI.   "
7090|NCT03193086|"     The development and progression of multiple sclerosis seem to be driven by concomitant     inflammation and, to a less well-defined degree, disturbances in metabolism of individual     cells of the human central nervous system as well as changes in the dynamical supply of blood     to the brain. These alterations in normal physiology can be quantified by investigating the     change in specific parameters over the time course of multiple sclerosis evolution. Amongst     these specific parameters, the ability of the so-called blood-brain-barrier to selectively     filter nutrients from the blood stream prior to passage into the nervous tissue, is disrupted     in multiple sclerosis, and the severity of this deficiency seem to be related to the     underlying disease burden. The present study utilises a novel imaging technology in order to     monitor changes in the integrity of the blood-brain-barrier over the course of treatment with     a biological disease modifying agent known as alemtuzumab. Alemtuzumab is a potent     immunosuppressant drug. It is hypothesised that alemtuzumab reverts the deficiency in     blood-brain-barrier integrity and, conversely, the severity of blood-brain-barrier disruption     at several time points during alemtuzumab treatment can be utilised as prognostic marker for     the requirement of additional administration of alemtuzumab beyond the regular treatment     regimen. In addition, several other factors are investigated by advanced imaging techniques     in combination with blood and urine samples in order to elucidate the possible underlying     mechanism of alemtuzumab efficacy. It is hypothesized that alemtuzumab normalises metabolic     alterations and changes in the blood supply through resolution of inflammation in the brains     of multiple sclerosis patients.   "
7091|NCT03193073|"     The fibroblast growth factor-23-bone-kidney axis is part of newly discovered biological     systems linking bone to other organ functions through a complex endocrine network that is     integrated with the parathormone/vitamin D axis and which plays an equally important role in     health and disease . Most of the known physiological function of fibroblast growth factor 23     to regulate mineral metabolism can be accounted for by actions of this hormone on the     kidney.In a recent experimental study, fibroblast growth factor-23 was shown to cause     pathological hypertrophy in rat cardiomyocytes by calcineurin-nuclear factor of activated T     cells and treatment with fibroblast growth factor -blockers reduced left ventricular     hypertrophy in experimental models of chronic renal failure.The current hypothesis is that,     in healthy individuals, iron deficiency stimulates increased production of fibroblast growth     factor23. At the same time, iron is thought to be the cofactor of enzymes taking part in the     degradation of intact fibroblast growth factor-23 and thought to have a role in the excretion     of degraded FGF-23 parts .Studies speculated that Angiotensin Converting Enzyme inhibitors     may exert their anti-proteinuria effects at least in part by reducing serum fibroblast growth     factor-23 levels although it is difficult from the results of this study to understand which     comes first and brings about the other; decrease in proteinuria or fibroblast growth     factor-23. Available evidence points to the deleterious effects of increased fibroblast     growth factor-23 level in proteinuria, but the precise molecular mechanism still remains to     be explored. An intricate and close association exists among parathormone, phosphorus, active     vitamin D with FGF23, but the independent role of the latter on proteinuria is the least     explored. Elaborately conducted studies that control effects of confounding factors     adequately are needed to demonstrate the independent pathogenic role of FGF23.   "
7092|NCT03193060|"     This study is a multi-centre, prospective observational study. The study plans to enrol 500     patients with localized or locally advanced prostate cancer who are eligible and intended to     be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate     implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical     sites in China. The effectiveness and safety data will be collected at baseline and each     visit within 26 weeks after treatment of Zoladex®.   "
7093|NCT03193047|"     The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9     inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL     cholesterol.   "
7094|NCT03193034|"     The primary objective is to investigate the change from pre-operative baseline to two year     postoperative functional performance improvement for the ATTUNE® primary, cementless TKA RP     system as measured with the KOOS questionnaire (KOOS-ADL sub-score) in the Japanese patient     population.   "
7095|NCT03192202|"     The investigators plan to investigate AFM13 and evaluate its ability to facilitate and     redirect the Natural Killer (NK) cells in eliminating CD30-positive lymphoma targets in the     skin and, by inference, other organs involved by the lymphoma.   "
7096|NCT03192189|"     Acute kidney injury is a frequent and growing complication associated with a risk of     progressing into a chronic kidney disease. Recent guidelines have recommended systematic     consultations with a nephrologist 3-6 months following hospitalization. Risk factors of     developing chronic kidney disease between hospital visits are understudied.   "
7098|NCT03193008|"     AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low     axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast     cancer.      Objective: To calculate the negative predictive value of AUS/FNAC in those patients with     breast cancer who meet ACOSOG Z0011 criteria.   "
7099|NCT03192995|"     This project is a placebo-controlled, double-blind randomized trial evaluating the     feasibility, tolerability, acceptability and adherence for lorcaserin among actively using,     men who have sex with men (MSM) with cocaine use disorders.The study will enroll 45     individuals who will randomly be assigned to either the treatment (lorcaserin) arm or the     placebo arm, to be taken twice a day for 12 weeks.   "
7100|NCT03192982|"     To investigate whether compression therapy with foot pump reduce post-operative edema,     facilitate wound healing of operation wounds, promote healing of ischemic ulcers and shorten     hospitalization, increase and improve the patient's subjective quality of life faster   "
7102|NCT03192956|"     Research hypothesis        -  There is a correlation between the quantity of fluid markers of CNS injury in blood and          DCS.        -  There is a correlation between quantity and kind of fluid markers of CNS injury in blood          and both diving profile and severity of DCS.        -  There is a correlation between the quantity of inflammatory markers in blood an DCS.      Objectives:        -  Assess whether individuals suffering decompression sickness exhibit fluid markers of          central nervous system injury.        -  Evaluate the correlation between quantity and kind of fluid marker of CNS injury and          clinical signs of neurological impairment.        -  Evaluate the correlation between quantity and kind of fluid marker of CNS injury and          clinical outcome after 3-6 months.        -  Assess whether individuals suffering decompression sickness exhibit inflammatory markers          in blood.   "
7103|NCT03192943|"     The purpose of this study is to assess the safety and tolerability for the combination     therapy of BMS-986205 and Nivolumab in patients with advanced tumors   "
27171|NCT02930291|"     The purpose of this study is to explore the effect of preoperative inflammation-based scores     on postoperative morbidity and mortality for laparoscopic gastrectomy.   "
7104|NCT03192930|"     Research hypothesis        -  Prolonged hyperbaric exposure will affect the central nervous system        -  Prolonged hyperbaric exposure will induce inflammatory changes        -  Prolonged hyperbaric exposure will affect fluid regulation in the body      Objectives:        -  To investigate the presence of cerebrospinal biochemical markers in blood during          prolonged hyperbaric exposure        -  To investigate changes in the quantity of cerebrospinal biochemical markers in blood          during decompression after prolonged hyperbaric exposure        -  To investigate the presence of inflammatory markers in blood during prolonged hyperbaric          exposure        -  To investigate changes in the quantity of inflammatory markers in blood during          decompression after prolonged hyperbaric exposure        -  To investigate if prolonged hyperbaric exposure alters fluid balance in the body   "
7105|NCT03192917|"     The purpose of this project is to verify the relationship between low intensity shock wave     treatment (LI-SWT) and increased scores in self-assessment regarding to erectile function     (ED) and sexual intercourse, in patients, who has undergone a radical prostatectomy (RP). The     data will be obtained from patients using international accepted sexual questionnaires prior     to the LI-SWT and 5, 12 and 24 weeks following treatment.   "
7106|NCT03192904|"     According to published studies, there are two main approaches in the dissection of     intersegmental plane: stapling devices and energy instrument separation. However, only a few     retrospective studies focused on the perioperative outcomes of these two approaches, and     there has been no definitive conclusion about which method is better. So the investigators     want to conduct a prospective study, trying to figure out this problem.   "
7107|NCT03192891|"     Numerous single-center studies have indicated gadolinium-enhanced stress CMR perfusion     imaging has excellent diagnostic accuracy for coronary artery disease and negative clinical     event rates, with its diagnostic accuracy exceeding nuclear scintigraphy. However, current     prognostic evidence supporting clinical use of stress CMR is limited by study size,     single-center settings with a predominance of academic centers, and a lack of real-world     study design. Large-scale multicenter real-world evidence from a registry will provide the     much needed information to guide evidence-based clinical adaptation that benefits patient     care.   "
7108|NCT03192878|"     Takayasu arteritis (TA) is a chronic inflammatory disease affecting large and medium caliber     arteries, particularly the aortic arch and its main branches. Clinical manifestations are     caused by the marked thickening of the wall of the involved vessels, resulting in lumen     narrowing and ischemia of the tributary districts. Therapy is based on the use of     corticosteroids, immunosuppressants, and biologic drugs including infliximab, a monoclonal     antibody blocking tissue necrosis factor (TNF)-alpha. Biosimilar infliximab is commercially     available and used in the treatment of various immune-mediated conditions. There are     currently no data on the efficacy and safety of biosimilar infliximab in the treatment of TA.      The investigators propose this monocentric, observational, prospective, open label study to     evaluate the efficacy and safety of biosimilar infliximab in the treatment of 30 patients     with TA. Specifically, the study will include: I) TA patients refractory to treatment with     corticosteroid and/or immmunosuppressive therapy, not previously treated with infliximab; II)     TA patients already receiving treatment with originator infliximab.      Biosimilar infliximab will be administered at dosages usually employed in the treatment of     TA. Specifically, patients not previously treated with the originator drug will receive     biosimilar infliximab intravenously at a dose of 5 mg/Kg at time 0, at week 2, at week 4;     thereafter, treatment will be administered every 4-6 weeks at a dose of 5-10 mg/kg based on     clinical judgement. In patients previously treated with the originator drug, biosimilar     infliximab will be administered at the same dosages.      To evaluate the efficacy of therapy, changes in clinical manifestations, laboratory     examinations, and imaging findings including angio-magnetic resonance imaging (MRI) of     thoracic and abdominal vessels and total body PET/CT scan will be evaluate at time 0 as well     as 6 and 12 months following treatment initiation. In order to evaluate the safety of the     study treatment, the investigators will stringently evaluate possible side effects of     treatment, including infusion reactions, changes in laboratory tests, infection, cancer,     autoimmune manifestations, neurological and cardiovascular symptoms.      The total duration of follow up for each patient will be 52 weeks from enrolment.   "
7109|NCT03192865|"     This study aims to assess consequences and causes of hemidiaphragmatic paralysis for     ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².   "
7110|NCT03192852|"     We aim to evaluate colorimetric changes after supervised whitening treatment, using Violet     LED light associated or not with carbamide peroxide 35% gel. 80 will be divided into: Group 1     - Violet LED light, Group 2 Violet LED light + carbamide peroxide 35% gel, Group 3 -hydrogen     peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for     aesthetic desire, after whitening treatment with Violet LED light without gel. The     colorimetric changes will be measured before, right after each whitening session in the end     of the period of 3 months, through the Vitapan Classical (Vita) color scale, and by digital     spectrophotometer. The sensibility degree will be measured by the Visual Analogue Scale (VAS)     . The gum tissues Group 4, will be analyzed by histomorphometrically. Quality of life will be     evaluated.   "
7111|NCT03192839|"     This clinical trial will evaluate the effects of giving supplements of PUFA to premature     infants.   "
7112|NCT03192826|"     To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine     0.2% in preventing intraocular pressure (IOP) elevations after neodymium:     yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.   "
7113|NCT03192813|"     Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic     Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic     CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions). The collected     data will also be used to apply for regulatory approval in France by HAS (Haute Autorité de     Santé).   "
7159|NCT03192163|"     This study will use a survey to examine relationships between culture, race, and ethnicity     with treatment preferences and perceptions for acne vulgaris.   "
7319|NCT03190057|"     The objective of this study is to evaluate effectiveness and safety of BioFreedom stent in     the real world daily practice as compared with other drug-eluting stents.   "
7114|NCT03192800|"     Spinal dural arteriovenous fistulas (SDAVFs) are the most common vascular disorder of the     spine and account for approximately 70% of spinal vascular malformation.They are a rare     pathology with an excepted incidence of only 5-10 new cases per million inhabitants per year.     Most fistulas are found in the thoracolumbar region and > 80% of all SDAVFs are located     between T6 and L2, whereas the cranio-cervical, cervical and sacral fistulas are more rare.     SDAVFs have an overwhelmingly male predominance (80%), with an age presentation in the fifth     or sixth dacede. It is presumed that SDAVFs are acquired diseases. A typical SDAVF is located     inside the dural mater close to nerve root. It is fed by a radiculomeningeal artery and     enters a radicular vein that merges in the perimedullary plexus. The presence of a shunt     leads to a reversal of blood flow to the spinal cord venous system, which then induces venous     hypertensive myelopathy.   "
30899|NCT02881294|"     The purpose of the study is to investigate the effect of Food, Gender, and Age on the     Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects   "
7117|NCT03192761|"     The investigators wish to compare 3 methods for reconstruction of the anterior cruciate     ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract     graft, as these methods influence the muscles around the knee differently. Methods using     bone-patella tendon-bone and hamstrings are performed as standard operations, and the use of     the iliotibial tract graft using a new method of reconstruction.      The purpose is:        1. To assess whether one of three different grafts used for reconstruction of the ACL shows          superior results compared to the others in relation to mechanical stability and          re-rupture rates.        2. To assess whether one of three different methods for reconstruction of the ACL shows          superior results compared to the others in subjective patient outcome measures.        3. To assess whether one of three different methods for reconstruction of the ACL shows          superior results compared to the others when considering specific symptoms and          complications that can be related to donor-site morbidity.        4. To assess whether one of three different methods for reconstruction of the ACL shows          superior results compared to the others when considering muscular power, muscle          coordination, and function.   "
7118|NCT03192748|"     The purpose of this study is get to know what and how Runzaozhiyang capsule in hospital     results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring     as registration research.   "
7119|NCT03192735|"     We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and     effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium     Capsules Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)   "
7120|NCT03192722|"     The effect of tinted filters and illumination on the visual performance of patients with low     vision (i.e., individuals with reduced vision that is uncorrectable with glasses, surgery or     treatments) has been a topic of research and discussion for many years, yet there is no     current consensus or practice standard for the evaluation and recommendation of colored     filters and/or illumination intensity. Anecdotally, there have been many subjective reports     of improvement in visual function and comfort with the use of tinted lenses. Previous studies     have attempted to elucidate the subjective improvements observed using vision tests, such as     visual acuity and contrast sensitivity, and the findings have been inconsistent.     Traditionally, filters and optimal illumination are prescribed clinically through a trial and     error method, which involves trying various filters and lamps haphazardly to determine which     if any are preferred by the patient. The investigators are proposing to evaluate whether the     illumination and filters chosen in office by participants using a new assessment tool the     LuxIQ/2 translate to overall patient comfort and improved speed, accuracy and print size     while reading, and to evaluate whether participants have the same illumination and colored     filter preference determined by the LuxIQ/2 in a clinical office setting and in their home     environment.   "
7121|NCT03192709|"     Adequate growth of the endometrium is crucial for implantation. Accordingly, the pregnancy     success rate of patients with a thin endometrium is low. Furthermore, there is a little     information about the factors responsible for impaired endometrial growth in patients with a     thin endometrium. The researches have revealed that nitric oxide (NO) release can cause     relaxation of vascular smooth muscle through a cyclic guanyl monophosphate (cGMP)-mediated     pathway. Sildenafil is a type 5-specific Phosphodiesterase inhibitor that augments the     vasodilatory effects of NO on vascular smooth muscle by preventing the degradation of cGMP     and could improve blood flow and endometrial thickness. This study is designed to evaluate     the effect of vaginally administered sildenafil suppositories on IVF/ICSI outcome of     infertile patients with repeated IVF/ICSI failures.   "
7122|NCT03192683|"     Examining custom made sling vs. off the shelf sling for immobilization following pediatric     upper extremity fractures.   "
7123|NCT03192670|"     The primary objective of this study is to confirm and compare the effect of methods of     Low-level light therapy (LED-T) in the mild cognitive impairment.   "
7124|NCT03192657|"     This is a 52-week, randomized, open and routine treatment controlled study. This study will     assess the safety and efficacy of basiliximab as an add-on treatment for interstitial     pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are     planned to be enrolled in a single center.   "
7125|NCT03192644|"     To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with     HCC and PVTT after hepatectomy.   "
7126|NCT03192631|"     There is a lack of incentive approach for patients who suffer from schizophrenia yet lack the     insight to accept treatment. Most existing approaches involve coercion and involuntary     hospitalizations. This study will explore whether patients with poor insight and lacking in     competence for treatment decisions will improve their acceptance and adherence of depot     injection antipsychotic medication if a financial incentive is offered. Ethical     considerations are also explored for this innovative pilot study   "
7127|NCT03192618|"     To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for     Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.   "
7128|NCT03192605|"     The objective of the study is to determine how wild blueberry consumption affects glucose     regulation, gastrointestinal hormones and satiety in healthy adults.   "
7134|NCT03192527|"     KN015,the active substance recombinant human Follicle Stimulating Hormone（FSH） Fc fusion     protein, which belongs to the pharmaceutical class gonadotropins.KN015 is proposed for     Assisted Reproductive Technology (ART) programs only. Its indication is Controlled Ovarian     Stimulation （COS）in combination with a gonadotropin releasing hormone (GnRH) antagonist for     the development of multiple follicles in women participating in an ART program. Due to its     prolonged duration of FSH activity compared to conventional recombinant FSH (rFSH), a single     subcutaneous injection of the recommended dose of KN015 may replace any daily rFSH     preparation in a COS treatment cycle. This study is to evaluation of the safety,     tolerability, pharmacokinetics and pharmacodynamics of KN015 in healthy Chinese female     subjects.   "
7135|NCT03192514|"     This study is a cluster randomized control trial aimed to measure the effectiveness of an     educational knowledge transfer intervention to prescribers on the discontinuation of two     targeted classes: Benzodiazepines andNon-benzodiazepine hypnotics.   "
8873|NCT03169764|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with HNSCC who have progressed on or after previous chemotherapy and     anti-PD-1/PD-L1 therapy.   "
7137|NCT03192488|"     This study seeks to determine whether a simple, single intervention of Cetirizine / Zyrtec®     use can improve exercise performance of active individuals when acutely exposed to altitude.     For this project, healthy subjects will perform steady state and progressive work rate     exercise, endurance performance time trials, and repeated sprint performance time trials in     the laboratory at a simulated altitude of 3000m (9900ft) after dosing with 10 mg of     Cetirizine or a placebo in a repeated measures design.   "
7138|NCT03192475|"     The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program     among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12     month outcome data (with a no treatment follow-up assessment at 24 months) to help determine     whether a continued contact group telephone intervention is feasible and effective in     enhancing health outcomes and physical functional ability in high risk adults (aged 65-80)     with obesity and cardiometabolic risk factors .   "
7139|NCT03192462|"     Patients who have pancreatic cancer that has has come back or has not gone away after     treatment, including the standard treatment for this disease or patients who are not eligible     for or have elected not to receive standard of care chemotherapy, and patients who will have     surgery after treatment for pancreatic cancer are eligible for this study. This is a research     study using special immune system cells called tumor-associated antigen (TAA)-specific     cytotoxic T lymphocytes, a new experimental therapy.      The proteins that are targeted in this study are called tumor-associated antigens (TAAs).     These are cell proteins that are specific to the cancer cell. They do not show, or they show     up in low quantities, on normal human cells. In this study, five common TAAs will be     targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study,     patients have been treated and so far this treatment has shown to be safe.      Investigators now want to try this treatment in patients with pancreatic cancer.      These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not     approved by the Food and Drug Administration.   "
7140|NCT03192449|"     Mass drug administration (MDA) of albendazole (ABZ) to school-age and pre-school-age children     is the currently recommended strategy for controlling soil-transmitted helminthiasis (STH) in     endemic areas. Recent mathematical modelling suggests that community-wide MDA will be     required in order to interrupt transmission of STH. DEWORM3 aims to determine the feasibility     of eliminating STH through expanded and intensified MDA strategies. In order to ensure     rigorous trial results, it is crucial that the definition of such MDA coverage is informed by     unbiased, empirical data. The Centro de Investigación Veterinaria de Tandil (CIVETAN) and     Instituto de Investigaciones en Enfermedades Tropicales Universidad Nacional de Salta     collaborate on scientific research related to pharmacokinetic studies of ABZ.      This proposal describes the request for funding from DEWORM3 to conduct a study of the serum     pharmacokinetic characteristics and urinary excretion of ABZ and its metabolites in     non-infected human volunteers to better understand the use of urinary analysis of ABZ as a     measure of MDA adherence in the context of DEWORM3.   "
7141|NCT03192436|"     Neuromodulation is a fast growing field that offers a wide range of applications for both     understanding and treating the brain. Future research for non-invasive neuromodulation will     need to elucidate the optimal frequency, duration, and intensity of stimulation for a variety     of technologies and diseases. Closed loop stimulation is thus a promising research area that     allows for responsive stimulation and real time symptom management. Our project is proposed     to develop and test a novel noninvasive neuromodulation integrating transcranial focused     ultrasound stimulation (tFUS) with electrophysiological source imaging (ESI-tFUS) to allow     evidence-based neuromodulation for brain research and the management of brain conditions.     Despite the recent developments and attention surrounding tFUS, relatively little is known     about the mechanisms and optimal parameters of this stimulation technology. The addition of     ESI neuroimaging, aimed at providing biomarkers to assess the effects of tFUS     neuromodulation, could provide crucial necessary information regarding the neural response to     the applied stimulation in real-time. In order for tFUS to be further developed and     transformed into a robust neuromodulation technology, an integrated electrophysiological     source-imaging-guided tFUS system to allow for individualized and responsive stimulation is     needed.      The purpose of this study is to develop and evaluate the proposed ESI-tFUS in human subjects     using motor and somatosensory paradigms.   "
7142|NCT03192423|"     This study explores lumbar puncture operators stress associated with their performance of the     procedure, across three experience levels: Experts, Intermediates, and Novices.      The study will investigate the association of this potential stress to patient experienced     stress and patient related outcomes of the lumbar puncture procedure.   "
7160|NCT03192150|"     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of     ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation     and pain associated with cataract surgery.   "
7161|NCT03192137|"     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of     ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation     and pain associated with cataract surgery.   "
7143|NCT03192410|"     The Alpha Omega Cohort is a prospective study of 4,837 state-of-the-art drug-treated Dutch     patients aged 60-80 years who had a clinically diagnosed myocardial infarction up to 10 years     before enrolment. During the first 40 months of follow-up, patients took part in an     experimental study of low doses n-3 fatty acids (Alpha Omega Trial, ClinicalTrials.gov     NCT00127452). At baseline (2002-2006), data on medical history, medication use, diet,     lifestyle and other factors were collected by means of questionnaires. Patients were     physically examined by trained research nurses and blood samples were obtained. Follow-up for     vital status and cause-specific mortality is ongoing. The trial was approved by a central     medical ethics committee (Haga Hospital, The Hague, The Netherlands) and all patients     provided written informed consent.   "
7178|NCT03191903|"     This is a multi-center, randomized, double-blind, parallel group, active comparator     controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the     relief of joint pain in subjects with OA of the knee.   "
7179|NCT03191890|"     This study is designed to generate a comprehensive survey of the use on the market of the     Anecova device within its intended indications according to the Instructions For Use. The     Anecova Registry is part of the Anecova quality system, to enable the Post Marketing     Surveillance and the Post Market Clinical Follow-up.   "
7144|NCT03192397|"     This phase II trial studies how well chemotherapy, total body irradiation, and     post-transplant cyclophosphamide work in reducing rates of graft versus host disease in     patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in     the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body     irradiation before a donor stem cell transplant helps stop the growth of cells in the bone     marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy     stem cells from a donor are infused into the patient, they may help the patient's bone marrow     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells     (called graft versus host disease). Giving cyclophosphamide after the transplant may stop     this from happening.   "
7145|NCT03192384|"     The head of nursing at University Hospital Coventry and Warwickshire (UHCW) plans to roll out     an intervention across groups of hospital wards over the next four months. The intervention     is designed to reduce falls as part of quality improvement for the hospital. However, the     head of nursing has asked the University of Warwick to help with the scientific evaluation of     the intervention - to find out whether and to what extent falls on the wards are reduced by     the intervention. The University of Warwick will have two functions:        1. To analyse data on falls to see if there has been a statistically significant drop in          fall rates before and after the intervention has been implemented across these groups of          wards        2. To determine a random order in which the groups of wards receive the intervention as          this will make it easier to distinguish cause and effect.   "
7146|NCT03192371|"     The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in     children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.   "
7147|NCT03192358|"     For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and     Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom.     Dysphagia places the affected individual at risk for secondary health consequences, including     malnutrition and aspiration pneumonia, and negatively affects quality of life.      Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more     slowly and reduce the risk of entry into the airway. However, there is limited understanding     about how changes in liquid thickness modulate swallowing physiology in individuals with     neurodegenerative conditions, and previous reports have shown that increased liquid thickness     may contribute to the accumulation of residue in the throat.      The purpose of this study is to explore swallowing physiology and function in individuals     with neurodegenerative conditions, across five levels of liquid thickness (thin,     slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify     boundaries of optimal liquid thickness, which maintain airway safety, without contributing     to the accumulation of significant residue. Results from this study will help guide the     clinical recommendations for thickened liquids in dysphagia management.   "
7148|NCT03192345|"     Primary Objectives:      Dose escalation (Part 1)      Part 1A (SAR439459 monotherapy)        -  To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of          SAR439459 when administered intravenously as monotherapy in adult patients with advanced          solid tumors.      Part 1B (SAR439459 and REGN2810 combination therapy)        -  To determine the MTD and/or MAD of SAR439459 administered intravenously in combination          with REGN2810 administered intravenously in adult patients with advanced solid tumors.      Dose expansion (Part 2)      Part 2A (SAR439459 monotherapy)        -  To determine optimal dose of SAR439459 administered intravenously in adult patients with          advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell          death-1) or anti-PD-L1.      Part 2B (SAR439459 and REGN2810 combination therapy)        -  To determine the objective response rate (ORR) of SAR439459 administered intravenously          in combination with REGN2810 in adult patients with selected advanced solid tumors.      Secondary Objectives:        -  To characterize the pharmacokinetic (PK) profile of SAR439459 administered as          monotherapy (Part 1A/2A) and in combination with REGN2810 (Part 1B/2B) and PK profile of          REGN2810 in combination with SAR439459 (Part 1B/2B).        -  To assess the immunogenicity of SAR439459 monotherapy (Part 1A/2A) and SAR439459 and          REGN2810 combination (Part 1B/2B).      Dose escalation (Part 1)        -  To characterize the overall safety and tolerability profile of SAR439459 administered as          monotherapy and in combination with REGN2810.        -  To identify the preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy          or in combination with REGN2810.      Dose expansion (Part 2)        -  To determine the progression free survival (PFS), time to progression (TTP), ORR, and          safety of SAR439459 as monotherapy and PFS, TTP and safety in combination with REGN2810          in adult patients with selected advanced solid tumors.        -  To confirm the optimal dose of SAR439459 administered in combination with REGN2810 (Part          2).   "
7149|NCT03192332|"     Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has     been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV     t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal     vessel occlusion in the anterior circulation has currently become a matter of debate and is a     relevant unanswered question in clinical practice.      The main objective is to determine whether subjects experiencing an AIS due to large     intracranial vessel occlusion in the anterior circulation will have non-inferior functional     outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects     treated with combined IV t-PA and MT.      The secondary objectives are to study causes of mortality, dependency and quality of life in     these AIS patients.   "
7150|NCT03192319|"     The purpose of this study is to determine the optimal timing of zoster vaccination to induce     both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with     history of hematopoietic stem cell transplantation(HSCT).   "
7162|NCT03192124|"     To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell     counts before and after irrigation with Bactisure Wound Lavage.   "
7163|NCT03192111|"     This purpose of this study is to evaluate the effects of a single dose of entinostat on     subjects with varying levels of renal impairment.      The primary objective of this study is to evaluate the pharmacokinetics of a single dose of     entinostat in adult subjects with mild, moderate and severe renal impairment compared to     healthy mean-matched subjects.      The secondary objective of this study is to evaluate the safety and tolerability of     entinostat in adult subjects with mild, moderate, and severe renal impairment and in healthy     mean-matched adult subjects.   "
7361|NCT03189511|"     The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue     activity in humans.   "
7180|NCT03191877|"     Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To     measure the effect of coffee consumption on intestinal motility after caesarean section for     the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary     outcome and secondary outcome will be measured.   "
7897|NCT03182491|"     The purpose of this study is to explore different mechanisms for anaphylaxis and find novel     biomarkers for this hypersensitivity syndrome. The study participants are patients with     anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion     reactions. The investigators will also include a group of healthy controls.   "
7151|NCT03192306|"     The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,     is safe and effective in the treatment of cold sores.      Subjects who meet the requirements to participate in the study will be put randomly, and     equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a     group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor     the site will know which treatment they will be getting. Once the subject has been assigned     to a treatment group, they will be given a kit containing a bottle of the treatment and     special swabs to apply the liquid. The subject will be told to take the kit home and wait     until they think they are starting to get a cold sore.      Once a subject begins to see something that they think is the start of a cold sore, they are     to immediately call the clinic. Once the clinic confirms that the subject is in fact starting     to get a cold sore, the subject will be told to open the kit and begin treatment. From the     start of treatment, there will be twelve (12) treatments, with either Merlin or placebo,     applied six (6) hours apart, up to 3 per day, over the next 96 hours (4 days). Each treatment     of Merlin or placebo is made up of three (3) applications given twenty (20) minutes apart,     for a total of thirty-six (36) applications. For each application, the subject will use the     special swab to put the Merlin or placebo solution on their cold sore.      Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until     either the cold sore is completely healed or 14 days from the start of treatment, whichever     comes first. At each clinic visit the cold sore will be observed to determine at what stage     it is at or if it has healed. The subject will also be asked how they are feeling.      Subjects will also be told to record in a diary the time of each application of Merlin or     placebo. They will also be asked to record the stage of their lesion and how much pain, if     any, related to the cold sore, that they are feeling.   "
7152|NCT03192293|"     This is a prospective single arm open-label Phase 2 study utilising the combination of     Fulvestrant, Metformin and Simvastatin in post-menopausal ER-positive metastatic breast     cancer, with the primary endpoint being Clinical Benefit Rate (defined as complete response,     partial response or stable disease, equal to or more than 24 weeks). The hypothesis is that     the addition of Metformin and Simvastatin to Fulvestrant will improve the Clinical Benefit     Rate from 40% (historical data from control arm of PALOMA-3 study) to 60%. A total of 28     patients will be enrolled over a period of 24 months. Eligible patients will receive 500 mg     Fulvestrant by intramuscular injection on days 1 and 15 of cycle one and then on day one of     each subsequent cycle (28 days). Patients will be given 850mg oral Metformin twice-a-day     (based on xenograft models which showed that Metformin had anti-tumor effects at a minimum     dose of 1500mg per day), and 20mg oral Simvastatin every night (drawing reference from the     investigators' group's window-of-opportunity study), daily throughout the cycle. As part of     the in-build safety and tolerability design, all patients will have a lead-in period of 7     days where they receive 850mg oral Metformin twice-a-day and 20mg oral Simvastatin every     night. Special adverse events of interest include lactic acidosis, diarrhea, bloatedness,     transaminitis and rhabdomyolysis. If no dose-limiting toxic effects (DLT) occur, Fulvestrant     will be commenced, and considered the start of cycle 1. If DLT occurs in any of the patients,     the combination of Metformin and Simvastatin will be modified for the affected patient as per     protocol, with further monitoring for another 7 days. This combination will be deemed safe     for that patient if no DLT occurs, following which cycle 1 can officially commence.      At the time of study entry, blood samples will be drawn to establish baseline physiological     parameters including fasting insulin, glucose, lipids and Homeostasis Model Assessment 2     (HOMA2). In patients who have accessible tumor sites and are willing to provide tissue for     translational research, pre- and post-treatment (at end of 8 weeks) biopsies will be taken     for correlative biomarker studies. Patients will be evaluated on an 8-weekly basis for     toxicities and efficacy assessments during the first 6 months of treatment, followed by     12-weekly thereafter until disease progression, unacceptable toxicities, or patient     withdrawal.   "
7153|NCT03192280|"     This trial will test the feasibility of various imaging devices to detect local skin     inflammation prior to clinical manifestation.   "
7154|NCT03192267|"     The primary goal of this study is to investigate lung disease, through pulmonary function and     high resolution chest CT, in newly diagnosed RA patients. Extra-articular disease occurs in     approximately 50% of RA patients, with the lung being a common site of involvement.      Investigators goal is to understand the prevalence of lung disease in early RA patients and     to better characterize it through questionnaires, imaging, and serum studies. Additionally,     the goal is to find novel biomarkers to predict lung disease in RA patients.   "
7155|NCT03192254|"     This research seeks to examine psychological factors that may impact relationship between     incentives and health behavior engagement, specifically fruit and vegetable consumption.     Additionally, it will compare the impact of two different incentive schedules on behavior     engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and     another providing delayed rewards (i.e. rewards received at the end of the study period),     with a control condition in which no rewards are offered. Study participants will provide     reports of their fruit and vegetable consumption each day for three weeks, and in the two     incentive conditions, they will receive small monetary rewards for their fruit and vegetable     consumption. Following the three week reporting and reward period, participants will complete     two additional assessments, measuring psychological constructs and behavior engagement     following the cessation of rewards. The study will also examine how cognitive and     anthropomorphic factors may contribute to intervention response and the effects on     psychological constructs.   "
7156|NCT03192241|"     The primary objective of this study is to pilot an intervention of providing manual breast     pumps at hospital discharge to low-income, first-time mothers and to generate initial     estimates of the effect of this intervention on exclusive breastfeeding rates at 3 months (12     weeks). In this pilot study, we will compare receipt of a breast pump and brief instructions     of its use to the active control of receipt of a children's book and brief instructions about     reading with baby. As a secondary objective, we will investigate mothers' attitudes and     opinions about the manual breast pump intervention with the goal of fine-tuning it to best     fit mothers' needs before a larger, multi-center trial. To support our objectives, we will     examine the following specific aims:        1. To test the intervention of providing low-income, first time mothers with a manual          breast pump at hospital discharge on exclusive breastfeeding rates at 12 weeks.           Hypothesis: Among low-income first-time mothers, receipt of a manual breast pump at          hospital discharge will lead to improved exclusive breastfeeding rates at 12 weeks          postpartum compared to receipt of a children's book.        2. To use qualitative methods to determine best practices associated with successful          implementation of a breast pump intervention to improve breastfeeding rates among          low-income, first-time mothers.        3. To test the effect of receiving a children's board book during the birth hospitalization          on parents reading to the baby at 3 months (12 weeks).   "
7157|NCT03192228|"     Therapeutic education programs allows in diabetic patients to promote self-care and better     perception of the disease      Our multidisciplinary program of therapeutic education regroups in one day: individual     interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity     and glycemic objectives workshop.      At the end of the program, individual and personalized goals are given to the patient.      This study aims to evaluate this program success rates and the psychological, anamnesis, and     sociological factors linked to success.   "
7158|NCT03192215|"     Objectives        -  Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention          of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.        -  Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin          increases with the severity of atrial cardiopathy.   "
7167|NCT03192046|"     Parkinson disease (PD) is a progressive neurological disease that results in characteristic     gait dysfunction. Gait problems include decreased velocity, decreased stride length,     difficulty with initiation of gait, postural stability problems and alteration in joint     kinematics.1 In this typically older patient population, these gait deviations affect their     participation in household and community activities. The standard of care is currently     focused on therapeutic exercise and cueing of various types (visual, auditory, verbal).     Current interventions have not been demonstrated to markedly improve gait kinematics, so     there is a need to identify interventions that could improve gait performance in this     population. Lower extremity bracing is a common and well-established intervention for gait     dysfunction with other populations, including stroke and brain injury. The braces allow for     improved stability, sensory feedback, and consistent tactile cues to allow patients to have     the best gait mechanics with each step. It is reasonable to hypothesize that appropriate     bracing may have the potential to improve gait function and kinematics in PD since these     patient often have gastroc-soleus weakness. Data from our early pilot studies indicates that     bracing individuals with PD can positively impact their mobility. This includes improvements     in velocity, step length, and dynamic balance. Additional data supported an upward trend in     quality of life.   "
7168|NCT03192033|"     Over the past years, arterial closure systems have tended to replace manual compression to     ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce     hemostasis and patient immobilization times, thus enabling early resumption of walking. These     devices have contributed extensively to the development of outpatient stays for cardiology,     vascular and neuro-radiology procedures.      However, main arterial closure devices use different technology to close the arterial     puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs     (an inner and an outer). For others, they are designed to close puncture sites delivering a     single monofilament polypropylene suture mediated by needles.      The investigators hypothesis is based on a different efficacy between both arterial closure     devices for peripheral arterial disease (PAD) patients.   "
7169|NCT03192020|"     Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed     parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment     strategy 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited     fasciectomy (LF) in patients who do not respond to PNF, 2) primary collagenase clostridium     histolyticym (CCH) followed by LF in patients who do not respond to CCH or 3) LF as the     primary (and secondary) treatment modality is the most efficacious and cost-effective in     treating Dupuytren´s contracture.   "
7170|NCT03192007|"     The goals of this study are:        -  To optimize and evaluate multiple kidney MRI methods; and        -  To investigate the potential of MRI in the assessment of transplant kidney functions; To          achieve these goals, we will perform pilot MRI studies with kidney transplant patients.          We will study if MRI can reflect different levels of kidney function. We will also          evaluate if MRI can differentiate causes for declining kidney function. Finally, we will          explore how MRI measures changes before and after medical treatment for worsening kidney          function.      You may be invited for MRI exams with different exam options. An MRI exam may use either of     two types of MRI machines at the CMRR: the 3T scanner and the 7T scanner. You may also be     invited for a multi-session exam. A description of the MRI exam types with different exam     options and the types of multi-session exams is provided later in this document.   "
7171|NCT03191994|"     To investigate the impact of a structured eight week exercise intervention as an add-on     therapy in treating Major Depressive Disorder. Using behavioural techniques and neuroimaging     to measure changes in brain function following an exercise intervention in people with     clinical depression. By correlating changes in the hippocampus with changes in HPA axis     hormones, inflammatory cytokines and growth factors it is possible to determine which of the     biochemical markers is most predictive of improved neural function.   "
7172|NCT03191981|"     This is a multi-centre phase I/II trial with an initial dose finding phase for     cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab for patients with     relapsed or relapsed / refractory multiple myeloma (MM) that have had at least 1 prior line     of therapy   "
7173|NCT03191968|"     This study will evaluate the feasibility of delivering a supervised physical activity program     plus standard exercise counseling (SPA+EC) versus a supervised physical activity plus     motivationally-enhanced behavioral counseling (SPA+BC) in prostate cancer survivors (PCS).     Fifty participants (n=25) will be randomized to receiving SPA+EC or SPA+BC (n=25). We     hypothesize that PCS receiving the SPA+BC intervention will result in greater increases in     objectively-assessed physical activity compared with PCS receiving the SPA+EC intervention.   "
7174|NCT03191955|"     One way cancer affects people is through weight loss. During this weight loss (called     cachexia), all types of body tissue are lost, but there is a greater rate of muscle loss than     fat. Cancer patients with cachexia show decreased quality of life, decreased response to     treatment (e.g. chemotherapy), increased complications from surgery, and shorter overall     survival. The Investigators aim to identify molecular (and patient) factors within the     tissues and bodily fluids of patients with cancer and cachexia in order to identify patients     at risk of weight loss, and identify potential therapies. For this, the Investigators aim to     take patient samples (muscle, fat, tumour, urine and blood) whilst patients are asleep     (general anaesthesia) during their operation to remove the cancer. These samples, and similar     samples taken in previous studies, will be analysed in the laboratory. Along with the sample     taking, the Investigators aim to perform nutritional assessments of patients before and after     surgery to get an accurate picture of their weight loss. This will include simple     measurements (e.g. height/weight), and computer reanalysis of their initial diagnostic     computed tomography (CT) scans (this study will not require any additional scans for     patients). The Investigators also aim to assess how their muscles function, by asking them to     perform walk tests and wear a physical activity meter, and assess their quality of life     through questionnaires. The Investigators aim to perform nutritional and functional     assessments pre-surgery and at 2-3 appointments post-surgery, up to a period of 12 months. At     these timepoints, the Investigators also aim to take repeat blood and urine samples, and     where possible, one additional thigh muscle biopsy. Repeated assessments allow comparison     between cancer and cured states. The study will take 2 years for patient recruitment.      For comparison, the Investigators also aim to examine similar tissue and fluid samples     (except tumour) from non-cancer patients who are having surgery for benign conditions (e.g.     hernia).   "
7175|NCT03191942|"     This project aims to study the effects of treatment characteristics on myopia control in     orthokeratology by investigating the effects of modified treatment zone by reducing the lens     back optic zone diameter on the effect of myopia control. The project will be a two-year     randomized, double-masked (examiner - mask axial length only) study conducted at The Hong     Kong Polytechnic University recruiting sixty Chinese subjects aged between 6-11. Subjects     will be randomly assigned to two ortho-k groups. The Control group will wear KATT BeFree lens     with a BOZD of 6mm while the Test group will wear KATT MC lens with a modified BOZD of 5mm.   "
7181|NCT03191864|"     Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by     eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting     corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and     pathological features of EoE.      APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This     study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with     EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance     treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.   "
7182|NCT03191851|"     Ascites is the accumulation of fluid inside the abdomen. This can happen when the liver fails     due to a substantial amount of scarring (cirrhosis). Patients (pts) must have this fluid     drained and as cirrhosis progresses, patients will require drainage of ascites repeatedly on     a regular basis, leading to frequent hospitals visits and increased complications.      The current drainage device is slow and doesn't always drain completely so pts have to return     repeatedly to keep symptoms under control.      A new device (called Melody) has been developed and specifically designed for the purpose of     draining ascites fluid, which the Investigators expect to drain faster and completely.      This study will compare the volume of ascites drained using the new 'Melody' catheter device     with that used in standard NHS practice. If the melody catheter device is confirmed as     superior to the current device this would improve patient experience (less frequent visits to     hospital and increased length of time between visits).      With fewer procedures performed per patient, the pressure on the NHS would be greatly reduced     in terms of time and costs.   "
7183|NCT03191838|"     The primary purpose of this study is to investigate whether audiovisual distraction can lead     to a reduction in standard of care administered intraoperative propofol consumption compared     to those who receive propofol sedation alone in adults having total hip or knee replacement     surgery under spinal anesthesia.   "
7184|NCT03191825|"     The purpose of the trial is to test the adjunctive effect of adding a lapse management system     to a best practices web- and mobile smoking cessation program.   "
7185|NCT03191812|"     The tDCS & Dual Tasking study will compare the effects of transcranial Direct Current     Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation)     on dual task standing and walking in older adults with and without a recent history of     recurrent falls.   "
7186|NCT03191799|"     This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and     tolerability of emicizumab in participants with congenital hemophilia A who have documented     inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12     or older, will be enrolled in this study and are expected to be enrolled at approximately 85     sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab     subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the     remainder of the 2-year treatment period.   "
7187|NCT03191786|"     This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate     the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1]     antibody) compared with a single agent chemotherapy regimen by investigator choice     (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or     metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any     platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology     Group [ECOG] performance status of 2-3).   "
7188|NCT03191773|"     Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be     infused back to patients with refractory /relapsed B cell malignancies, including lymphoma     and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T     cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and     treatment efficacy.   "
7189|NCT03191760|"     The purpose of the study is to see if Behavioral Activation and Social Engagement for PTSD     (BASE for PTSD), an individual therapy for PTSD, will help Veterans with PTSD 1) through     improved understanding of how PTSD affects them, 2) by reducing ways in which they avoid     meaningful activity due to PTSD, 3) by enabling them to do more of the things they really     care about, and 4) by improving, strengthening, and building up their social supports.   "
7190|NCT03191747|"     Examining whether men with greater Avoidance to Femininity subscores using the Male Role     Norms Inventory - Short Form will demonstrate differences in skin care knowledge, attitudes,     and behaviors, compared to men with lower subscores.   "
37676|NCT02792491|"     This is Phase II prospective trial of addition of rituximab to reduced dose CHOP chemotherapy     in DLBC L patients aged 65 years and over.   "
7193|NCT03191708|"     Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of     coronary stenosis. The purpose of the FAVOR II China study is to evaluate the diagnostic     accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to     compare the diagnostic accuracies between online QFR and online QCA, with FFR as the     reference standard.   "
7203|NCT03191578|"     The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal     immunological response and provide safety information after the use of RUTI® administration     to individuals with NMIBC.      The study will enroll individuals treated with Transurethral resection of bladder tumor     (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable     candidates for BCG therapy and who meet all eligibility criteria.      Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of     25 μg RUTI® or placebo. After vaccination, individuals will receive the standard intravesical     Bacillus Calmette-Guerin (BCG) therapy with induction course (weekly BCG for six weeks) and     maintenance course (three courses of weekly BCG for three weeks at 3, 6 and 12 months after     induction).      After the last intravesical BCG administration (BCG15, end of Interventional Phase)     immunological assays will be performed and data will be analyzed. At the end of the     Interventional Phase the blind will be opened, except for the study physicians who will     remain blind during all the follow-up. All the individuals will be followed up for three     years since TURBT.   "
7946|NCT03181854|"     This study verifies whether integrated Early Palliative Care for Stage 4 gastric and     non-small cell lung cancer patients who have failed first-line treatment, and Stage 4     pancreatobiliary cancer patients improve qualify of life and enhances the ability to overcome     the current crisis.   "
7194|NCT03191695|"     Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from     non-progressive disorders that develop in the immature brain. CP leads activity limitations     of movement and posture development. Motor problems in CP are usually accompanied by sensory     and perceptual disorders, cognitive disorders, communication and behavioral disorders,     epilepsy, and secondary musculoskeletal system problems. The first 20 years of life is     characterized by rapid growth and specific changes in physical, social, and psychological     development. Social participation and independence of children and youth are related to the     changes in this period. Participation can be identified as being involved in life situations     and it reflects the social aspect of functionality. The problems which can be come across in     life situations are identified as participation limitation. In literature, no adequate study     has investigated the functional inadequacy, activity and participation of children with CP;     this project has been planned in order to specify the importance in rehabilitation     interventions more detailed. This project aims to specify whether the functional levels     correspond to the activity and participation limitations of children with CP living in Ankara     city center and determine the effects of their functional status on activity, participation     and quality of life. This investigation will be pioneer in indicating the activity and     participation limitations of children with CP. According to the results, these limitations     will be overcome and the quality of life of children with CP will be increased. The CP     follow-up database in Ankara will be specified so their physical activity and participation     levels will be followed periodically and CP profile will be determined in Ankara.   "
7195|NCT03191682|"     This study is carried out to test the safety of a study drug called PRL3-ZUMAB. PRL3-ZUMAB is     an investigational drug that has not yet been approved by the Food and Drug Administration     (FDA) or any other regulatory authorities for commercial purposes. This is the first study in     which PRL3-ZUMAB will be given to humans. The study drug has been tested in animals and was     found to be well-tolerated with minimal side effects. This research study will test different     doses of the drug to see which dose is safest in people.   "
7196|NCT03191669|"     Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s     and more recently human papillomavirus vaccine. There was an important flu incidence during     the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health     professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been     evaluated yet.      Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with     MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory     vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify     potential limitations to vaccines in general in patients with MS.      Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes     (France).      Data will be collected through an auto-questionnaire administered during an out-patient visit     or hospitalization, during a two-week period.      Statistical analysis Description of the percentage of patients exposed to the flu vaccine,     and to other vaccines. Stratification according to demographics (age, sex) and MS related     criteria (disability level, relapse in the year before, disease-modifiying drug) Expected     results Vaccine exposure of patients with MS will be put in perspective with the general     population exposure. The study can provide information regarding potential reluctance of     patients with MS towards vaccines. This could lead to develop specific communication tools     for patients with MS and/or health professionals.   "
7197|NCT03191656|"     This is a post market trial to be conducted at several sites in Germany. The device has CE     approval in the EU. The purpose of this observational registry is to collect post market data     in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety     and quality of life outcomes as a new treatment for patients with heart failure in a real     world practice setting.   "
7198|NCT03191643|"     Description of the role of a post-operative external beam radiotherapy in patients with     differentiated thyroid cancer.   "
7199|NCT03191630|"     Inactivity is a common problem among older kidney transplant recipients (KTRs) and is     associated with their high incidence of obesity and cardiovascular problems which are the     leading cause of death for KTRs. However, the combination of SystemCHANGE activity trackers     holds promise for increasing physical activity of KTR patients post-surgery.      This pilot study will incorporate Fitbit health trackers with an intervention of questions     about influences to physical activity in a population of kidney transplant recipients who are     at particularly high risk of cardiovascular disease and death.   "
7200|NCT03191617|"     The objective of the study is to compare two human milk fortifiers with different protein     content and LCPUFA in a group of very low birth weight infants.   "
7201|NCT03191604|"     This study tests the impact of narrow band imaging (NBI) on endoscopists' accurate detection     of visible lesions and dysplasia in patients with Barrett's esophagus, as well as the effect     of NBI on the choice of primary treatment modality among endoscopists performing endoscopic     eradication therapy (EET).   "
7202|NCT03191591|"     The First 1000 Days (conception to age 2) is a crucial period for the development and     prevention of obesity and its adverse consequences in mother-child pairs and their families.     The overall aim of the First 1000 Days program is to work across early-life systems to     prevent obesity, promote healthy routines and behaviors, address social determinants of     health, and reduce health disparities among vulnerable children and families at the MGH     Chelsea and Revere HealthCare Centers, and DotHouse Health.      The study aims to simultaneously implement and evaluate an obesity prevention program across     early life systems to reduce the prevalence of obesity risk factors within racial/ethnic     minority families, close the gap in maternal-child health disparities, and assess and address     social determinants of health.   "
7215|NCT03191422|"     This study aims to explore if the LSVT BIG® - a motor learning based treatment program     designed for rehabilitation of people with Parkinson's disease could be beneficial for     chronic stroke rehabilitation. A single-case experimental design with two adult participants,     will be monitored for performance on self-selected goals before, during and after     participating in the treatment program.   "
7260|NCT03190837|"     The study aims are to: a) identify the long-term natural history of Gaucher disease, b)     evaluate long-term treatment efficacy of enzyme replacement therapy (ERT) and substrate     reduction therapy (SRT), and c) identify potential long-term complications of this disorder.     These aims will be accomplished through long-term record review of individuals with all three     types of Gaucher disease.   "
7204|NCT03191565|"     BACKGROUND: Borderline Personality Disorder (BPD) is a serious and debilitating mental     disease characterized by difficulties with emotion regulation that leads to unstable and     self- destructive behavior and relationships. The prevalence of BPD is between 1% and 5% in     the Scandinavian population with similar prevalence rates found in US epidemiologic surveys.     BPD increases the risk for suicide by 4-fold, while patients with comorbid BDP and tendency     to self-harm have a further 2-fold attenuated risk. BDP is difficult to treat, and even more     difficult when co-occurring with other disorders. Dialectical Behavior Therapy (DBT) is the     best validated treatment for BPD, showing medium to large effect sizes as compared to     treatment as usual for anger, parasuicidality (suicide attempts without an intention to die)     and poor mental health. DBT uses self-monitoring as the mainstay of treatment, which helps     patients regulate their emotions by means of emotional regulating skills, and reduce problem     behavior. Self-monitoring has traditionally been done by means of daily paper diaries. The     latest developments in smartphone applications have generated alternatives for ecological     momentary assessments of problematic behavior that even prompt patients to practice skills     targeting emotion regulation. An example of this is Monsenso's DBT self-monitoring mHealth     application (mHealth means mobile health, public health supported by mobile phones). Such     applications may enhance treatment success in BPD patients, as they are available to patients     at all times.      OBJECTIVES: To evaluate the Monsenso's mHealth app with respect to clinical efficacy as an     adjunct to DBT-psychotherapy treatment and utility as a way to measure outcomes in BPD     patients.      METHODS: The study will be a 2-year multi center, randomized controlled trial. In both     conditions patients will be followed for one year. Self report data of DBT-skills-use,     positive and negative affect, Standardised self report questionnaires on Emotion regulation     ability; functioning; borderline symptoms. will be given pre, post and every month. The     treatment arm (n=50) will receive the mHealth app that includes coaching suggestions and     instructed how to use it. The control arm (n=50) will only use a pen and paper based     self-monitoring, as traditionally used in DBT-treatment.      STUDY ENDPOINTS: Primary: mean number of days passed per new DBT-Skill learned. Secondary:     Borderline personality disorder(BPD)-symptoms, Emotion regulation ability, ratio     positive/negative affect.   "
7205|NCT03191552|"     To evaluate the effects and feasibility of lycra based compression garment called Stabilizing     Pressure Input Orthosis (SPIO) vest on posture and balance during sitting and gross manuel     dexterity, parent satisfaction with the garment and to to compare 2 hours vs 6 hours of daily     wear time.   "
7206|NCT03191539|"     This study aims to evaluate more objectively, through an imaging technique such as     ultrasound, changes in joints and entheses of patients with active psoriatic arthritis (PAs)     who will start treatment with Apremilast after the failure of other therapies such as     synthetic DMARD (metrotrexato , Leflunomide ...).      The hypothesis of the study is that the technique of ultrasound can demonstrate the efficacy     of Apremilast in the treatment of patients with active PAs   "
7207|NCT03191526|"     The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous     injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan.   "
7208|NCT03191513|"     The purpose of this study is to investigate whether there are differences in postprandial     metabolic indices following interesterified fats used commercially versus the corresponding     un-interesterified blend.   "
7209|NCT03191500|"     This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy     of a steerable catheter in the establishment of vascular intervention access. five centers     participate in this study. The total enrollment number is 68. In the procedure of vascular     interventional surgery or angiography diagnosis, the steerable catheter are used to building     vascular interventional access. Evaluate the safety and efficacy of the product, by the     observation and record the relative index of subjects intraoperative and postoperative     (discharge) before and after 30 days .   "
7210|NCT03191487|"     The primary objective of this study is to compare an experimental organization for     chemotherapy session planning based on early, standardized, and prioritized means of data     transmission via secure e-mail (laboratory results) and the use of a smart phone (for     clinical toxicity data) compared to the regular organization, in terms of the rate of     prescriptions of chemotherapy prepared at the latest the day before a session and then     administered in full (over a 6-month observation period) among colorectal cancer patients in     need of cancer treatment in an outpatient setting.   "
7211|NCT03191474|"     CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated     linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus     standard of care (SOC).   "
7212|NCT03191461|"     This is a cross-sectional pilot study. The investigators seek to obtain early information     pertaining to the relationship between measurements of myocardial perfusion reserve and     myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior).   "
7213|NCT03191448|"     Currently, it is not known what the dimensional changes might be following a molar site     extraction which has been grafted with FDBA and covered with a collagen wound dressing. The     purpose of the proposed study is to examine the clinical healing following ridge preservation     using freeze dried bone allograft (FDBA) with a collagen wound dressing barrier (CollaPlug®)     in a molar extraction site.      I   "
7214|NCT03191435|"     In diabetic individuals, changes in ventilatory muscle strength and lung function have been     demonstrated over the years. The onset and progression of chronic complications in diabetes     should be avoided by reaching glycated hemoglobin (HbA1c) levels below 7%. The control of     glycemia through the measurement of HbA1c is fundamental to avoid complications. The     inspiratory muscle training has been used in several clinical situations, and may be an     alternative for individuals with type 2 diabetes mellitus who have difficulties performing     conventional exercises. The long-term effect of inspiratory muscle training on glycemic     control has not been tested yet. The aim of this study is to evaluate the effects of     inspiratory muscle training on glycemic control in individuals with type 2 diabetes.   "
7216|NCT03191409|"     End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD).     Abnormalities of cognitive function and high levels of depression or anxiety incidence are     characteristic of hemodialysis patients. In this research project, the investigators subject     in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research     design, using multimodal neuroimaging data，combining with the interact relationship between     changes of brain morphology, the dysfunction of resting-state and-task state with cognitive     impairment and abnormal emotions.Establish brain structure-function change model associated     with dialysis progression, Explore imaging markers of central and disease development     characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of     kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD     patient.   "
7973|NCT03181503|"     This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study     to evaluate the safety and efficacy of nemolizumab over a 12-week treatment period in     patients suffering from PN compared to its placebo.   "
7217|NCT03191396|"     This study is conducted in Europe. The aim of the study is to compare the effect of     semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg     once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes.      The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at     the clinic and 3 phone calls with the study doctor. At the visits, participants will have a     number of tests, for example: general health checks, blood samples, heart and eye checks etc.     Participants will also fill in some forms about their health and satisfaction with their     diabetes treatment.   "
7218|NCT03191383|"     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the     investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the     vaccinated women   "
7219|NCT03191370|"     To compare the effectiveness of reducing discomfort during flexible nasal endoscopy using     simple distraction techniques compared to topical anaesthetic spray and a control group that     does not receive topical anaesthetic spray or a distraction technique.   "
7220|NCT03191357|"     This protocol is designed to facilitate the recruitment, screening and registry of Military     Service Members (SMs) and individuals eligible for care in the Department of Defense (DoD)     healthcare system. This protocol will serve as an entry point for SMs, retirees and other     beneficiaries, to facilitate their participation in Center for Neuroscience and Regenerative     Medicine (CNRM)-sponsored clinical research studies at participating CNRM sites.     Specifically, this protocol will be comprised of an initial evaluation of participants, to     include questionnaires, a blood draw, and neuroimaging. This evaluation will enable     investigators to direct participants to CNRM-sponsored natural history, observational, or     interventional protocols that are most relevant to the individual interests and needs of each     participant. Other approved CNRM protocols may continue to recruit participants directly into     their respective studies, and may refer participants to this study.      The objective of this protocol is to develop a broad-spectrum military subject recruitment     database that will collect and store preliminary data on research participants who are     interested in and potentially eligible for current and future CNRM sponsored studies. The     effectiveness of the recruitment methods utilized in this protocol will be evaluated to     determine the most successful outreach approaches and recruitment tools for the enrollment of     participants, including both active and reserve component SMs along with others who are     eligible for care in the DoD healthcare system, who have experienced traumatic brain injury     (TBI), psychological health (PH) concerns, or are interested in participating in studies as     controls. Control participants may include (i) those with exposure to primary blast without     the development of TBI, (ii) those with physical injuries without experiencing head injury,     and (iii) healthy participants (non-injured, non-TBI, non-PH).   "
7221|NCT03191344|"     after established the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy we     further extented the clinical value of Intraoperative Parathyroid Scores System in Treatment     decisions of calcium treatment time and improve recognition skills of parathyroid in     Clinicians   "
7222|NCT03191331|"     The aim of this pilot study is to conduct a dietary intervention for overweight (body maas     index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the     effect of the intervention on gestational weight gain and the prevalence of gestational     diabetes between the intervention and control groups.   "
7223|NCT03191318|"     The aim of this study is to compare two postoperative recovery pathways namely, enhanced     recovery after surgery (ERAS) pathway and conventional recovery pathway after laparoscopic     sleeve gastrectomy with respect to outcomes including hospital stay, postoperative pain and     other postoperative outcomes.   "
7224|NCT03191305|"     In past few years new anticoagulants have been developed which directly inhibit thrombin or     factor X.factor x inhibitor is available in Pakistan. The superior efficacy of Rivroxaban has     been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in     prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study     ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug     interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis.     This study is therefore required to find its efficacy in CVT patients as well as its     comparison with Coumadin   "
7225|NCT03191292|"     The purpose of this study is to establish a bacterial epidemiology in patients who present a     prosthetic joint infection and for which a surgery is necessary. At the time of the first     surgery, as the bacteria responsible for the infection are not known, a probabilistic     antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then     adapted to the bacteria from samples collected during the surgery when they are identified     (the delay is 14-21 days).      The study will focus on bacteria identified on samples collected during the surgery; the     delay between the implantation of the prosthesis and the presentation of symptoms will be     considered : more than one year vs. less than one year.      Investigators assume that there is not the same type of bacteria involved in those two cases     of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are     presented more than one year after implantation of the prosthesis. A probabilistic     antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the     chance to cure the patient (increasing of relapse).      The result of this study will allow medical doctors to have an optimal probabilistic     antibiotherapy, depending on the delay between implantation of the prosthesis and the     presentation of the symptoms.   "
7226|NCT03191279|"     The study aims to assess the effect of first aid from bystanders on survival, admission     length, and need of ICU-stay for trauma victims.   "
7237|NCT03191136|"     This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess     the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.      Hypothesis: YHD1119 is showing equal equal pharmacokinetics in fasted and fed state.   "
7238|NCT03191123|"     This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE)     for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided     into two group.One group will receive hepatic resection, while an another equivalent group     patients will be treated with Transarterial Chemoembolization.   "
7227|NCT03191266|"     At least 60% of Veterans with an alcohol use disorder will relapse within 6 months of     treatment, irrespective of the type of treatment they receive. This indicates that currently     available interventions for treating AUD in Veterans are not effective in helping them     achieve long-term sobriety. Repetitive transcranial magnetic stimulation (rTMS) is a brain     stimulation method that is at the forefront of innovative, non-invasive, and safe treatments     for AUD. However, there have been no studies that specifically determined the effectiveness     of rTMS treatment for Veterans with AUD. This project will evaluate the effectiveness of rTMS     treatment in promoting long-term abstinence in Veterans suffering from AUD. Assisting     Veterans in achieving long-term and sustained sobriety is critical because it is associated     with the best medical, cognitive, psychiatric, and psychosocial recovery from AUD.   "
7228|NCT03191253|"     UCSF and Project Open Hand (POH), a community based organization in San Francisco which     provides meals and groceries to chronically ill clients in the Bay Area, have partnered to     conduct an initial randomized controlled trial (RCT) of the Changing Health through Food     Support (CHEFS) pilot intervention implemented by POH. The intervention consists of providing     comprehensive, medically-appropriate food support, individual nutritional counseling, and     group-based nutritional education over 6 months to low-income clients who have been diagnosed     with HIV in order to improve their viral load and health-related quality of life (primary     outcomes) as well as depression, ART adherence, food security and diet quality (secondary     outcomes). We will randomize 200 participants to the intervention (n=100) or control (n=100).     Participants will be followed for 6 months. The investigators will assess outcomes at     baseline and 6-month follow-up using a quantitative survey and blood draws. In addition, the     investigators will conduct a qualitative study at follow-up in a subset of participants to     understand perceived impacts, barriers and facilitators.   "
7229|NCT03191240|"     The investigators aimed to evaluate the effect of AMCPR (Augmented-Medication CardioPulmonary     Resuscitation: administration of additional vasopressin to titrate to arterial diastolic     blood pressure over 20 mmHg) on cardiopulmonary resuscitation results and outcomes in     out-of-hospital cardiac arrest patients.   "
7230|NCT03191227|"     The aim of the Cork and Kerry Study Phase II (Mitchelstown cohort recruited 2010-11) is to     provide an updated profile of glucose tolerance status, cardiovascular health and their     related factors in an Irish adult general population sample and to compare the findings with     those obtained during baseline assessment of Phase I of the Cork and Kerry study (1998) and     the rescreen (2008).   "
7231|NCT03191214|"     The purpose of the study is to assess the temperature changes that take place throughout the     body in a real world setting, when a patient is given general anaesthesia. Specifically we     will investigate the movement of body heat from the core to the peripheries at the beginning     of surgery. This will be measures with a series of temperature sensors and infrared     thermography   "
7232|NCT03191201|"     In this study the investigators aim at addressing potential relationships between iron stores     and glucose homeostasis. Iron (i.e. Ferric Carboxymaltose) will be perfused to     pre-menopausal, iron-deficient non-anaemic women suffering from a chronic fatigue syndrome     and parameters related to glucose homeostasis, parameters related to metabolic syndrome and     inflammation will be measured before and after the intervention.   "
7233|NCT03191188|"     Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine     complication of chronic kidney disease that has been associated with impaired quality of life     and cardiovascular complications. While levothyroxine is one of the most frequently     prescribed medications in chronic kidney disease patients, little is known about its efficacy     and safety in this population. This study will investigate 1) whether levothyroxine     adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid     hormone replacement improves quality of life and cardiovascular markers, without leading to     wasting in dialysis patients.   "
7234|NCT03191175|"     The clinical challenges confronting patients with HIV has shifted over the past 10 years from     acquired immunodeficiency syndrome to chronic diseases including atherosclerosis,     neurocognitive disorders, and osteoporosis. Chronic low grade inflammation and monocyte     activation have been consistently associated with comorbidities in HIV patients. Indeed,     recent studies indicate that inflammatory mediators including IL-6, IL-1, sCD14 and s CD163     produced by monocytes, but not T-cell activation, predict Non-AIDS-related events in     virologically suppressed HIV-infected persons treated with combined antiretroviral therapy     (cART), highlighting the important role of monocyte activation in the occurrence of     comorbidities in cART-treated HIV infected patients. Yet, the underlying molecular pathways     of persistent monocyte activation in cART treated HIV-infected patients remains incompletely     characterized. Our preliminary results: 1/ establish a link between the activation of the     inflammasome, the increased of pyrimidine-derived metabolites and the cardiovascular risk in     a cohort of elderly patients; 2/ show that treated HIV-patients are characterized by     increased soluble IL-1b or IL-18 in their blood suggesting that the inflammasome pathway is     activated.      Objectives: In this study we will characterize the molecular pathways underlying persistent     monocyte activation in treated HIV patients, through the implication of the activation of the     inflammasome machinery: 1. Characterization of NOD like Receptor (NLR) expression in     monocytes for IL-1b and IL-18 secretion (inflammasome activation); 2. Characterization of     circulating metabolites that active the inflammasome machinery; 3. Evaluation of the link     between the activation of the inflammasome, the increased of circulating metabolites and the     non-AIDS related comorbidities.   "
7235|NCT03191162|"     A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens     (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment     of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion     of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the     first 12 months after starting treatment. The study will be performed in Spain, Brazil,     Argentina and Colombia.   "
7236|NCT03191149|"     This phase II trial studies how well osimertinib works in treating patients with non-small     cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back.     Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
7239|NCT03191110|"     The main aim of this observational, prospective cohort study is to assess associations of     diet and other lifestyle factors with colorectal cancer recurrence, survival and quality of     life.   "
7261|NCT03190824|"     This is an open-label, multi-center Phase IIa study to evaluate the efficacy, safety, and     immunological response of OBP-301, a telomerase specific replication-competent oncolytic     adenovirus in patients with unresectable metastatic melanoma. This is a proof-of-concept     study that will be undertaken in male and female patients with unresectable Stage III and IV     melanoma.   "
7262|NCT03190811|"     The purpose of this study is to compare the clinical efficacy and toxicity of anti-PD-1     monoclonal antibody alone with anti-PD-1 monoclonal antibody plus autologous dendritic     cells-cytokine induced killer cell (DC-CIK) immunotherapy in advanced tumor     patients.Furthermore,to characterize response to therapy we intent to evaluate the role of     cell-free DNA (cfDNA) and immune repertoire based on the next generation sequencing.   "
7241|NCT03191084|"     Marijuana is one of the most widely used substances. This study will characterize the     persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated     driving over a several hour time period. The data obtained from simulated driving, cognitive     tests, and biological assays of THC will be used in analyses aimed at identifying what tests     or combination of tests predict both recent use and driving impairment risk.      Eligible participants will undergo a full day screening visit, if still eligible they will     come to Hartford Hospital in Hartford, Connecticut to take part in the full study.     Participation requires overnight stays between each of the five study visits. On each of the     study days participants are dosed with either a low dose of THC marijuana, a high dose of THC     marijuana or placebo marijuana, (the low and high doses are repeated once each, order in     which the study drug is given is double blind and chosen at random.)   "
7242|NCT03191071|"     The study is randomized clustered pragmatic trial whose objective is to decrease unnecessary     antibiotic prescription in adult patients with lower respiratory tract infection managed at     primary care level in Switzerland, using a simple algorithm based on 2 point of care test     results   "
7243|NCT03191058|"     The study will involve a randomized, double blind, non-inferiority clinical trial with two     treatment arms conducted in two international academic medical centers (CAMH and UT     Southwestern). The investigators are pursuing a non-inferiority clinical trial in an effort     to compare MST - a new treatment in TRD - to RUL-UB-ECT with the primary aim of demonstrating     that MST is non-inferior to RUL-UB-ECT vis à vis remission of suicidal ideation.      Treatment will be administered three days per week. Suicidal ideation will be assessed using     the SSI. Depressive symptoms will be assessed with the HRSD-24 to ensure comparability with     previous NIMH supported brain stimulation treatment studies. Remission will be defined as a     SSI=0 and HRSD-24 < 10 and > 60% decrease from baseline over 2 consecutive ratings.     Therefore, there will be no specific minimum number of treatments that patients must receive     to be classified as remitters. Patients who do not meet remission criteria after 21 treatment     sessions will be considered non-remitters. This maximum treatment number was chosen     considering the possibility that MST and RUL-UB-ECT may require more treatment sessions to     achieve remission. Also, the pilot data from the CAMH study site demonstrated that the mean     number of MST treatments needed to achieve remission was 14.67 + 6.35 treatments. Upon     completion of the study, remitters and non-remitters will be referred back to their referring     clinician for treatment as usual, which may include MST, ECT, ECT plus pharmacotherapy or     psychotherapy, depending on provider recommendation and patient preference. The subject blind     will be maintained until the completion of the entire study.   "
7244|NCT03191045|"     This study will: 1. validate MRI motility method with concomitant perfused manometry method     in healthy adult participants. 2. measure exploratory endpoints of interest including GI     fluid volumes in 21 adult healthy volunteers studied twice.   "
7245|NCT03191032|"     The implementation of early sensory re-education (SR) techniques, aimed to preserve the     cortical hand area, such as the use of audio-tactile interaction, becomes an important     strategy to obtain also a better sensory function. The aim of this study was to investigate     sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and     DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the     hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17     participants were divided into two groups: the training group, trained on the protocol with     the sensor glove model, and the control group, untrained. After six-month follow-up, no     difference was observed between groups, related to sensory function, especially tactile     gnosis. Despite this, the early training with this sensor glove model seems to provide some     type of cortical audio-tactile interaction, contributing to previous studies that focus in     early SR of the hand using the integration of different sensory modalities.   "
7246|NCT03191019|"     The purpose of this study is to determine whether a mobile-phone based intervention is     effective in supporting smoking cessation among Chilean women   "
7247|NCT03191006|"     Using double blind, randomized controlled design to investigate the short-term therapeutic     effects of function of customized insoles on children with developmental delays   "
7248|NCT03190993|"     The purpose of the current study is to test if weight change is differentially affected by     consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form     over 1 month.   "
7249|NCT03190980|"     Background: It was long believed that newborns could not experience pain. As it is now     documented that newborns have all the necessary systems to perceive pain, pain management can     no longer be ignored.      Pharmacologic agents are not recommended in neonates for pain relief in minor procedures and     still there is debate regarding the efficacy of oral glucose, in different strengths, on     alleviation of pain among neonates.      Aim: The objective of this study is to assess the efficacy and safety oral administration of     glucose, in different concentrations, on pain relief in full term neonates undergoing heel     prick test.      Methods: The investigators will conduct a prospective, randomized, double blind placebo     controlled trial to investigate the effect of glucose solution on alleviating the pain of     heel prick test in around 360 healthy full term newborns who will be randomly allocated to     one of three groups (around 120 neonates in each group): First group will receive 5% glucose,     second group will receive 30% glucose and third group will receive sterile water as a     placebo, 2 minutes prior to the procedure.      Specially trained nurses will take turns to carry out blood sampling. Neonatal pain will be     assessed by the Neonatal Infant Pain (NIPS) as well as by duration of crying, changes in     heart rate, respiratory rate and oxygen saturation.   "
7268|NCT03190733|"     In this study, a randomized, prospective, multicenter, open cohort study was conducted to     investigate patients with acute leukemia (14～60-year-old) with different ATG doses (10 mg /     kg and 12.5 mg / kg ) in fludarabine, busulfan, cyclophosphamide and antilymphocyte globulin     (FBCA) pretreatment protocol of Haploidentical hematopoietic stem cell transplantation     (haplo-HSCT). The purpose is to compare the incidences of chronic graft vs host disease     (cGVHD) in haplo-HSCT recipients receiving different dose ATG and one year leukemia relapse     after transplantation. The main objective was to investigate the optimal dose of ATG for     decrease cGVHD and not increase one year relapse leukemia after haplo-HSCT. Its significance     is to provide evidence-based medical evidence to reduce the occurrence of cGVHD and to     improve the quality of life of patients with haplo-HSCT.   "
7251|NCT03190954|"     Background:      The chemical messenger dopamine carries signals between brain cells. It may affect addiction.     Heavy use of pain medicines called opioids may decrease the amount of dopamine available to     the brain. Researchers want to study if decreased dopamine decreases self-control and     increases impulsiveness.      Objective:      To learn more about how opiate use disorder affects dopamine in the brain.      Eligibility:      Adults 18-65 years old who are moderate or severe opiate users      Healthy volunteers the same age      Design:      Participants will first be screened under another protocol. They will:        -  Have a physical exam        -  Answer questions about their medical, psychiatric, and alcohol and drug use history        -  Take an MRI screening questionnaire        -  Give blood and urine samples        -  Have their breath tested for alcohol      Participants will have up to 3 study visits.      They will have 2-3 positron emission tomography (PET) scans. A radioactive chemical will be     injected for the scans. Participants will lie on a bed that slides in and out of the     donut-shaped scanner. A cap or plastic mask may be placed on the head.      Vital signs will be taken before and after the PET scans.      Participants will get capsules of placebo or the study drug. They will rate how they feel     before, during and after.      Participants will have their breath and urine tested each day.      Participants will have magnetic resonance imaging (MRI) scans. They will lie on a table that     slides into a cylinder in a strong magnetic field. They may do tasks on a computer screen     while inside the scanner.      Participants will have tests of memory, attention, and thinking.      Participants will wear an activity monitor for one week.   "
7253|NCT03190928|"     Background:      Follicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for     cancer research. They help scientists better understand differences in the cancer biology of     different patients. Researchers want to collect serial samples over time from people with     follicular lymphoma to help them design future treatments.      Objective:      To collect a variety of samples from people with follicular lymphoma to study how these     diseases progress and respond to treatment.      Eligibility:      Adults at least 18 years old who have been diagnosed with, but have not yet had any treatment     for, follicular lymphoma.      Design:      Participants will be screened with medical history and physical exam. They will answer     questions about daily functioning. They will have blood and urine tests. They may have scans     and have tissue samples taken.      Participants will be monitored about every 4 months for up to 2 years. They will repeat     screening tests. They will have a cheek swab. A small brush will be rubbed against the inside     of the cheek to wipe off some cells.      Participants will have imaging scans about every 8 months for up to 2 years.      Participants may have a bone marrow aspiration and biopsy. The hipbone will be numbed with a     small needle.      A needle will be put into the hipbone, and about 2 tablespoons of bone marrow will be taken     out through the needle.      Participants will continue being monitored every 6 months for up to 5 years, then 1 time a     year.   "
7254|NCT03190915|"     This phase II trial studies how well trametinib works in treating patients with juvenile     myelomonocytic leukemia that has come back or does not respond to treatment. Trametinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
7255|NCT03190902|"     Computer-assisted rehabilitation of attention deficits in pediatric Multiple Sclerosis and     ADHD patients recruited during the study Cognitive impairment in Pediatric Onset Multiple     Sclerosis: research of biomarkers predictive of cognitive impairment progression.   "
7256|NCT03190889|"     The overall goal of this project is to reduce risk of second anterior cruciate ligament (ACL)     injury in vulnerable populations (active athletes between 14 = 24 years old) through the     identification of relative injury risk groups based on subject-specific movement patterns     prior to second injury, as well as through the determination of effect for differential     rehabilitation protocols following initial ACL reconstruction and prior to return to sport.     As nearly one-third of athletes who have a primary ACL injury and return to sport will     experience a secondary injury, results from the proposed work will allow us to prospectively     identify high risk patients who are the most appropriate recipients of enhanced treatment,     including targeted training, which may reduce the risk of second ACL injury. Secondary ACL     injury has the potential to end athletic careers, promote the development of osteoarthritis,     and have debilitating effects on quality of life. Hence, the information gathered in this     investigation will offer ACL injured athletes the optimal potential to reduce or potentially     prevent these negative health effects before they are initiated.   "
7257|NCT03190876|"     With a prevalence of up to 25%, seroma formation is among the most common complications of     body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by     the body spontaneously, however, larger seroma volumes need to be evacuated via puncture     aspiration to prevent wound healing disturbances and infection, leading to major patient     discomfort and a prolonged hospital stay. There is increasing controversy regarding the     efficacy of surgical drains in seroma prevention. This study compares the incidence rate of     seroma in three study arms with different usage of drains.   "
7258|NCT03190863|"     Motor imagery has shown promising results to optimize tenodesis grasp in individuals with     C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after     tetraplegia requires further study with higher level of evidence. In addition, controlling     covert practice remains difficult due to the absence of overt movements. However, similar     brain activity measured during both over and cover movements makes possible to provide visual     information about the covert practice performance using neurofeedback.      The Investigators thus designed this multicentric randomized controlled trial to investigate     the effect of motor imagery with or with no visual neurofeedback on grasping capabilities     after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain     activity measured by electroencephalography namely knowing the covert practice performance     would results in greater grasping improvement in response to practice as compared to motor     imagery practice alone.   "
7259|NCT03190850|"     This study aims to evaluate the effect of inspiratory muscle training on sleep apnea in the     elderly. The patients screened will be randomized and allocated into two groups, intervention     and control. In the intervention group, the patients will perform the exercises with the     inspiratory muscular training apparatus called Powerbreathe with progressive load, according     to its inspiratory muscular force. The control group will perform the same exercises, with     the same apparatus, but without load.   "
7264|NCT03190785|"     The benzoic acid derivatives sodium and potassium benzoate are preservatives that are     commonly added to food and beverages to inhibit microbial growth and prevent spoilage. In the     US the major source of benzoate intake is beverages. Studies have shown that piglets or     chicks fed low levels of benzoic acid have greater feed efficiency and gain more weight than     control fed animals. It has also been shown that benzoic acid inhibits the release of a key     metabolic hormone, leptin, from isolated adipocytes (fat cells). Inadequate leptin levels     result in increased appetite, decreased metabolic rate, weight gain, insulin resistance and     increased diabetes risk.      The primary aim of the proposed research is to directly determine if benzoate consumption in     human volunteers results in lower levels of leptin, decreased metabolic rate and increased     insulin resistance. If so this would implicate benzoic acid as an obesogen and would help     inform more effective approaches to obesity prevention and treatment. A secondary aim of the     study is to establish a connection between benzoate exposure and biomarkers in urine that can     be used to help treat obese patients.   "
7265|NCT03190772|"     The study aimes at identifying whether positive expectations have an impact on the way     depressive participants experience emotions in the form of sadness.   "
7266|NCT03190759|"     Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It     is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest     tightness and cough that vary over time and in intensity, together with variable expiatory     airflow limitation. This definition was reached by consensus, based on consideration of the     characteristics that are typical of asthma and that distinguish it from other respiratory     conditions .      Asthma is a problem worldwide, with an estimated 300 million affected individuals .It appears     that the global prevalence of asthma ranges from 1% to 18% of the population in different     countries .   "
7267|NCT03190746|"     It is hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs)     (rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226) in the YWHAH gene could     be related to RA disease severity.   "
7270|NCT03190707|"     The aim of the project is to develop and evaluate an interdisciplinary and cross-sectorial     intervention targeting pregnant women with psychosocial vulnerabilities. The objective is to     1) detect depression, anxiety and personality disorders in the pregnant women, 2) to increase     knowledge sharing across the health care sectors and 3) strengthen the parents' parenting     skills and thereby support a secure attachment between parents and child and thus promoting     the child's well-being.      The overriding hypothesis is that an early multi-stringed, interdisciplinary and     cross-sectorial intervention, with a long-term perspective from the early pregnancy     throughout the child's first years of life, can effectively prevent disorders in the     parent-child relation. The approach is to detect and treat depression and anxiety in the     mother and strengthen the parents' parenting skills in families with maternal psychosocial     vulnerabilities. The hypothesis indicates that the over-all intervention will result in     improved interaction between child and parents which will make it possible to detect higher     maternal sensitivity and a higher level of well-being among both children and parents in the     intervention group compared to the control group.      The projects' specific hypotheses are;        -  A systematic screening for anxiety, depression and personality disorders in the          midwifery consultation will imply more pregnant women with symptoms of anxiety,          depression and personality disorders being detected and offered treatment in the          intervention group compared to the control group.        -  Knowledge sharing across health care sectors will improve by the implementation of a          joint consultation involving the vulnerable pregnant woman/families, the midwife and the          health visitor and by a systematic transmission of information when the woman leaves the          post-natal ward and is transferred to the health visitor.        -  Parental skills in psychosocial vulnerable pregnant women and their partners can be          strengthened by a parental training program and by education and dialogue about          perceived challenges and breast-feeding. Parents in the intervention group will          therefore gain greater knowledge on what it takes to make breast-feeding work          successfully, be able to interact more appropriate with their children, and improve          their mentalization skills and experience less stress compared to parents in the control          group.   "
7271|NCT03190694|"     This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with     non-diabetic chronic kidney disease.   "
7272|NCT03190681|"     The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic     and noradrenergic agent, onto the different components of motivation: decision-making, effort     allocation and instrumental learning.   "
7273|NCT03190668|"     The purpose of this research study is to compare the current standard of care for     prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of     Cefazolin during pediatric spinal surgery.   "
7274|NCT03190655|"     Burn injury is the result of an energy transfer that destroys the skin and adjacent tissues.     Partial thickness burn wounds are painful and difficult to manage. The aim of burn treatment     in partial thickness burns is to promote rapid wound healing, decrease pain, protect wound     from infections, minimize scar formation and functional impairment In recent years, there are     progressive development of new dressing material with a variety of option for depth adapted     wound management. Many wound dressings are available for superficial and partial thickness     burns. Hydrogel based wound dressing provides good biocompatibility with the skin and mucosa     and promotes hydration of the wound bed.      Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with     aluminium that was designed to reduce acute pain in the treatment of superficial and partical     thickness burn injuries.      Up to date, no evidence regarding integrated with aluminium sheet in hydrogel based wound     dressings for the use in partial thickness burns. Therefore this trials is aimed to evaluate     the efficacy and safety of Aluminaid versus Hydrogel for the treatment of partial thickness     burns.   "
7275|NCT03190642|"     The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use     of one gram of methylprednisolone administered intravenously prior to orthognathic surgery.     This is largely based on the work of Habal. The administration of one gram of     methylprednisolone can be concerning for the anesthesiologist since this is an unusually     large dose of steroid in comparison to use in other surgical specialties. As with most     medications, the chances of steroid-related complications increase with increasing doses of     steroids.      The researchers are proposing a prospective, double-blind randomized control trial to     determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively     instead of one gram of methylprednisolone.   "
7276|NCT03190629|"     Compared to conventional hemodialysis (HD), on-line hemodiafiltration (OL-HDF) achieves a     more efficient removal of uremic toxins and reduces inflammation, which could favourably     affect nutritional status. The aim of this study was to evaluate the 1-year effect of OL-HDF     on nutritional status and body composition in prevalent HD patients.   "
7277|NCT03190616|"     Limited agents have been approved after standard first and second line treatment. Regorafenib     and Trifluridine/Tipiracil (TAS-102) are still not approved in China.Apatinib has shown     significant efficacy in refractory advanced gastric cancer regarding PFS and OS with     controllable toxicity.This study is aimed to explore the efficacy,safety as well as     predictive biomarker in advanced colorectal cancer failed to standard therapy in Chinese     population.   "
7278|NCT03190603|"     Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing     spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness,     peripheral arthritis, enthesitis. Controlling aforementioned symptoms are one of the goal in     treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine.     Ankylosis can limit range of motion and lower the quality of life.      Non-steroidal antiinflammatory drug (NSAID) and Tumor necrosis factor (TNF)-a inhibitor are     the current treatment options for axial SpA. These medications can improve pain and stiffness     of axial SpA patients, however preventing bony ankylosis is not proven. Current study showed     attenuating inflammation at early stage could prevent further bony destruction and ankylosis     in axial SpA. Present study is designed to discover the therapeutic effect of NSAID whether     NSAID could recover the early inflammatory bony change (bone marrow edema at MRI) and prevent     further bony change.   "
7279|NCT03190590|"     Noninvasive stimulation of the central nervous system, including transcranial magnetic     stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly     used in the investigation of cortical plasticity. The purpose of our study is to understand     mechanistically—at the neurophysiological and systems levels—how the brain learns new motor     skills. We propose to study the acquisition, consolidation, and retention of motor skill     learning in healthy subjects. At the behavioral level, we will use movement kinematics to     quantify and characterize movement, which allow us to infer functional strategies used by the     brain to reduce movement errors. At a neurophysiological level, we will use TMS to document     changes in cortical circuitry, which will allow us to infer neuroplastic changes possibly     subserving these strategies. At a systems level, we will enhance motor system excitability     using tDCS, which will enable us to infer the contribution of the stimulated area to the     motor system's ability to learn new skills.   "
7655|NCT03185676|"     The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose     and insulin have already been study in the past. The aim of the current study is to evaluate     the long term effect of the probiotic bilberry drink on glucose tolerance and insulin     resistance in healthy adults and in comparison to a control drink.   "
7280|NCT03190577|"     Familial amyloid neuropathy due to transthyretin gene mutations (TTR-FAP) is a rare autosomal     dominant inherited disease resulting in the abnormal multi-system deposition of amyloid     proteins. These deposits produce a multi-organ disease. AP is usually fatal 10 to 15 years     after onset of symptoms if untreated. The prevalence of the disease remains still poorly     understood and usually the search for this pathology is done in a third line of     investigation. So the average time to diagnosis is extremely long, from 12 to 24 month. Now     that we have etiological treatment ( famidis (Vyndaqel®) and Diflunisal (Dolobid)) of this     disease, it is essential to be able to detect FAP patients as early as possible. With our     study, we decided to test for TTR mutation all patients presented with neuropathy of unknown     etiology at the first line of investigation. The goal of this study is to evaluate the     prevalence of FAP-TTR among neuropathy and defined the best strategy to test this population     for TTR mutations.   "
7281|NCT03190551|"     The primary aim of this study is to compare needle shaft visibility between the     retroclavicular approach and costoclavicular approach for infraclavicular brachial plexus     block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the     differences between the two groups in sensorial block success rate, block performance time,     block performance related pain, motor block success rate, surgical success rate,     complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.   "
7282|NCT03190538|"     Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in     children. Steatosis without significant liver cell injury or fibrosis is the most common form     of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult     population have variably suggested that steatosis is a benign nonprogressive condition and     NASH is recognised as a potentially serious condition with significantly risk of morbidity     and mortality.      A growing body of evidence suggests that children with NASH frequently show histopathological     features that differ from those of adults. The prevalence of this pattern in a wide range of     paediatric cases as well as other histopathological lesions and their relevance and     prognostic significance in children with NAFLD remains to be determined. Thus the     investigators would like to conduct a study of biopsies and clinical information to document     the histological features of paediatric NAFLD, to explore the natural history of paediatric     NAFLD, and to determine the frequency and prognostic value of these features.   "
7284|NCT03190512|"     There is a relationship between depression and periodontal disease. This relationship may be     double-sided. A psychological state such as anxiety, depression, body image, and self-esteem     may be affected from the symptoms of periodontal disease.   "
7285|NCT03190499|"     Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers     and lymphomas are the most common ones among them. During medical treatment children with     cancer are at risk of neuromuscular and musculoskeletal complications such as reduced muscle     strength, gross and fine motor performance impairment, decreased energy consumption. These     neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and     quality of life of the children. Childhood cancers have negative effects on sleep. The aim of     this study is to identify the status of sleep, fatigue, and quality of life in children with     various types of cancer and to examine the relationship between these conditions.The general     situation of children will be determined according to findings from this study.   "
7297|NCT03190343|"     The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult     to have histology of these tumors as the samples taken during ERCP were performed under      blind  radiology control. So the diagnostic accuracy was insufficient.      The arrival of A new optic fiber endoscope used by only one operator had improved the     diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had     proved outdated for several reasons: poor manoeuvrability, perfectible optical vision,     optical fibers fragility and cost.      A new generation of endoscopes with digital vision appeared and would allow an increase in     diagnostic accuracy related to better vision and manoeuvrability.      The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed     with digital vision.   "
7997|NCT03181191|"     Delineation of the anatomical location, cellular origin and molecular basis of gut-derived     glucagon secretion   "
7286|NCT03190486|"     Crying is the primary signaling strategy available to the human newborn for eliciting     parental care. Yet, the investigators only have superficial understanding of the information     carried by cries, and how this information is perceived by parents. Using modern tools of     sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims     to investigate cry-induced brain activation in adult depending on the cry's acoustic     properties expressing various degrees of stress and distress levels. For that, Adults will be     tested inside a fMRI magnet to determine their brain activations elicited by different babies     cries according to whether the cry was evoked in a pain situation or not. The cerebral     activity will be investigated in relation to acoustic features of cries (e.g. with pitch     and/or roughness variations). To test if the gender or parentally of adult listeners     influence their perceptions and brain responses, the task will be applied to 2 different     groups (men and women not-parents). The hypothesis is that the brain of adult listeners will     be able to discriminate adequately the intensity of the pain mediated by the cries. This     process should involve brain areas such as the insular and the orbito frontal cortex that are     known to participate in the integration of pain intensity and pain controls. The experiment     should also determine which one of the acoustic features is able to transmit pain and to     recruit brain areas involved in pain processes.   "
7287|NCT03190473|"     Indication for use: The Svelte DES is indicated for improving coronary luminal diameter in     patients with symptomatic heart disease, including patients with non-ST elevation MI due to     discrete de novo native coronary artery lesions. The treated lesion length should be less     than the nominal stent length with a reference vessel diameter of 2.50 mm - 4.00 mm   "
7288|NCT03190460|"     Approximately one in three older adults fall annually and it is the primary cause of     traumatic injury in older adults. While exercise and balance programs have been shown to be     effective in reducing fall risk, maintaining behavior change is known to be difficult. Thus     additional interventions need to be validated to add to our current armamentarium to reduce     falls in older adults. Cognitive training (CT) involves exercises that target specific     cognitive tasks, such as memory or processing speed. It has been speculated that routinely     performing such tasks may increase functional ability. Recent work has pointed to an     increased risk of falls in community-dwelling older adults who have alterations in specific     cognitive tasks. Thus the purpose of the proposed study is to demonstrate the feasibility and     to explore the effectiveness of a 16 week CT intervention to reduce risk and incidence of     fall and improve outcomes up to 1 month post-intervention in a group of community dwelling     older adults at risk for fall.   "
13778|NCT03105089|"     preconditioning of no debate has a valuable effect upon myocardial protection .     pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative     inotropic support   "
7289|NCT03190447|"     Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier     against external contamination. Currently, in Corporació PT after orthopedic surgery,     traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is     placed. In many cases the appearance of blistering caused by the use of these conventional     dressings is observed, which increases the risk of infection, pain and the final cost of the     procedure. There are other types of dressings that could improve these aspects but     comparative data are not currently available. Main objective: to identify the dressing that     better preserves the integrity of the skin.      Design: Prospective randomized comparative study of 5 types of dressings used in total knee     and hip arthroplasty surgical wounds (TKA and THA).      Secondary Objectives: To identify the dressing that provides greater advantages and minor     inconveniences in TKA and THA surgery.      Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110     patients   "
7290|NCT03190434|"     This study is designed to demonstrate that the performance of the AL-SENSE developed by     Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be     experiencing an amniotic fluid leakage or a water breaking. The AL-SENSE is an extended     shelf-life product that is technically simple, fast to react, visually readable, and     therefore enables women to test the cause of any unidentified wetness. An additional,     secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and     specificity that are comparable to those specified for the currently marketed AMNIOTESTTM     (nitrazine yellow swabs; PRO LAB Diagnostics) product.   "
7291|NCT03190421|"     This purpose of this study is to see if expanded urine culture techniques used in the     laboratory improve the clinical care of women over standard urine culture techniques.   "
7292|NCT03190408|"     To conduct a multicenter observational cohort study to determine the variability in fluid     resuscitation in shock in a broad range of areas in hospitals and treatment areas.   "
7293|NCT03190395|"     Atrial fibrillation (AF) is the most serious atrial electrical activity disorders, is also     one of the common tachyarrhythmias.Circumferential pulmonary Vein Isolation (CPVI) is     considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently     reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the     5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also     high in the follow-up period. Therefore it is necessary for us to explore whether the success     rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial     fibrillation is higher than the pure CPVI.   "
7294|NCT03190382|"     The overall goal of SHOWME-PAD is to make the existing evidence-base on treatment outcomes     -focusing on health status outcomes that reflect the patients' perspective - more     transparently available to patients and providers, such that more informed, evidence-based     shared treatment decisions occur. INTEGRITY-PAD has the potential to radically reorganize     care delivery to patients with PAD such that more value for the patient and society will be     created.   "
7296|NCT03190356|"     The purpose of this study is to show the effectiveness of Soberlink's remote alcohol     monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample     size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to     improve clinical outcomes and manage financial risk through facilitating early interventions     and other means of mitigating recidivism and costly treatment episodes from AUD population.   "
7298|NCT03190330|"     The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM     (ibrutinib capsule 140 milligram [mg]) under actual conditions of use, and to understand the     incidence of adverse events (AEs) (serious and non-serious AEs).   "
7299|NCT03190317|"     This is a study of study of My HealtheVet (MHV) use by Veterans diagnosed with Human     Immunodeficiency Virus (HIV) and VA providers/staff who care for them. We hope to learn and     understand how MHV can improve the self-management of chronic conditions like HIV. First, we     will review Veteran medical records to look at the relationship between use of MHV and     whether it has a positive or negative impact on the Veteran's management of HIV. Next, we     will interview Veterans to find out how they use MHV for self-management and both Veterans     and providers to find out why they choose to use (or not to use) specific MHV tools. Lastly,     we will use the information we found from the first two steps and create an intervention that     will encourage non-MHV users to use the MHV tools that can help them achieve their     health-related goals. Once the intervention has been developed, Veterans and providers will     participate in a cognitive walkthrough where they will help the researchers test the     intervention to see if it is usable, possible, and acceptable.   "
7656|NCT03185663|"     The fracture of the proximal femur is a common traumatic pathology in patients aged over 70     years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During     this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing     antiescarres slippers. Mobilization, source of pain, is also problematic.      759/5000   "
7300|NCT03190304|"     Studies with new drugs in the treatment of heart failure (HF), such as the combination of     valsartan/sacubitril, also known as LCZ696, have demonstrated important clinical impact on     the morbidity and mortality outcomes in HF population. However, the effect of LCZ696 on the     pathophysiological mechanisms of HF such as exercise tolerance (peak VO2) and peripheral     muscle blood flow is not known. Since LCZ696 is a new drug with promising effects on the     treatment of HF, the objective of the present study will be to evaluate the effect of LCZ696     in patients with HF on: 1) peak VO2, 2) 6-minute walk test, 3) peripheral muscle blood flow,     4) muscle strength, and 5) body composition.   "
7301|NCT03190291|"     Noting the need for evidence-based cancer survivorship care, the American Society of Clinical     Oncology (ASCO) published guidelines for screening, assessment, and care of psychosocial     distress (anxiety, depression) in adults with cancer. These guidelines recommend screening     all adults with cancer for distress and treating those with moderate or severe symptoms using     a stepped-care approach tailored to distress severity.      The purpose of this study is to test a method of implementing this stepped-care approach in     community oncology practices caring for rural survivors, using self-directed and telehealth     approaches based on cognitive-behavioral theory.   "
7302|NCT03190278|"     Phase I, first-in-human, open-label, dose-finding study of UCART123 administered     intravenously to patients with Acute Myeloid Leukemia (AML), followed by a dose-escalation     stage in Relapsed or Refractory AML patients and a dose expansion stage in     Relapsed/Refractory AML patients, and in poor-prognosis, newly diagnosed AML patients in the     European LeukemiaNet (ELN) Adverse genetic risk group.   "
7303|NCT03190265|"     The purpose of this study is to study the safety and clinical activity of nivolumab and     ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine     followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with     pancreatic cancer.   "
7304|NCT03190252|"     Research hypothesis        -  Diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing          gas will affect the central nervous system.        -  Diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing          gas will induce inflammatory changes.      Objectives:        -  To investigate the presence of cerebrospinal biochemical markers in blood after diving          to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.        -  To investigate the presence of inflammatory markers in blood after diving to depths up          to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.        -  To investigate the presence of venous gas emboli (VGE) in blood after diving to depths          up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.   "
7305|NCT03190239|"     Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the     main pathological type is non-small cell lung cancer (NSCLC). Most of them present with     advanced stage at diagnosis. This design is to study maintenance therapy with pemetrexed plus     apatinib after first line induction therapy four cycles for advanced non-squamous     non-small-cell lung cancer.   "
7306|NCT03190226|"     The aim of this study was to evaluate the potential of L-PRF in increasing the width of the     keratinsed mucosa around implants. Furthermore, it was assessed whether this surgery was     associated with significantly less post-operative discomfort for the patient compared to Free     Gingival Graft surgery. L-PRF for increasing keratinised mucosa around implants.   "
7307|NCT03190213|"     This is an open label, non-randomized phase 2 study to assess overall response rate (ORR),     clinical benefit rate (CBR), overall survival (OS) and progression free survival (PFS) in     patients with poorly differentiated, high grade neuroendocrine tumors treated with     pembrolizumab 200mg Q 3 Weeks.   "
7308|NCT03190200|"     The purpose of the study is to determine if by using MRI changes can be identified changes     early on in the knees of young children that may be at risk for developing osteochondritis     dissecans. If MRI can identify changes then better council can be offered about the risks of     future activity and treatment options.   "
7309|NCT03190187|"     The aim of the present intervention study is to determine the effectiveness of manipulation     techniques.   "
7310|NCT03190174|"     This study investigates the safety/toxicity and potential anti-tumor activity of sequential     administration of nivolumab and escalating doses of the mTOR inhibitor ABI-009 in advanced     UPS, LPS, CS, OS and Ewing sarcoma.   "
7311|NCT03190161|"     The purpose of this study is to explore the impact of self-selected music listening which     targets disrupting the reward process maintaining smoking and additionally attenuating the     reward processing deficits associated with schizophrenia. Five participants with     schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual     session of self-selected music listening for a half an hour.   "
7312|NCT03190148|"     In this study glucose metabolism of pregnant women with a history of bariatric surgery, obese     pregnant women and normal weight pregnant women was investigated. Three to six months after     delivery the assessment of Glucose metabolism was repeated and the amount of ectopic lipids     in the liver, heart and muscle was measured.   "
7313|NCT03190135|"     BOKS, Build Our Kids' Success, is a before-school physical activity program that has been     implemented in over 2,000 elementary and middle schools. Students participate in the program     for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a     non-randomized control trial seeking to 1) examine the extent to which participation in the     before-school BOKS program improves, health, well-being, and performance, and 2) compare the     results of a two-day-per-week versus a three-day-per-week program.   "
7314|NCT03190122|"     Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With     Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single     Blinded Trial.   "
7315|NCT03190109|"     Aiming to validate the use of bone age determined by ultrasound (BAUS) in Brazilian children,     normal control students will be studied. X-Ray bone age (RXBA) and BAUS will be determined in     500 children and adolescents of both genders, with chronological age varying from 6-16 years.      Concordance analysis and the correlation between both BA determination methods will be     performed.   "
7316|NCT03190096|"     The present study is designed as a observational prospective, multicentre, international. The     main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB     in a prospective manner.   "
7320|NCT03190044|"     Migraine is a highly disabling disorder that affects hundreds of millions of people around     the world. Yet, a little number of prophylactic treatments are available still now. The     limited number of available drugs leads to a wide use of nutraceutical compounds in migraine     therapy. To improve the efficacy, some of these nutraceuticals were combined. So far, we do     not know if these combinations are really more effective than the single compounds alone, or     an anti-synergic effect could be present because of a reciprocal antagonism of effects. For     this reason, we decided to test the efficacy of a fixed combination of magnesium, partenium,     andrographis, co-enzyme Q10 and riboflavin (PACR) as prophylactic treatment for migraine in a     randomized controlled double blind study.   "
7321|NCT03190031|"     The present study aims at evaluating the effect of respiratory muscle training in adult     patients with cystic fibrosis on lung function, exercise performance and quality of life.   "
7322|NCT03190018|"     The study is a proof-of-concept of peritoneal dialysis with the Carry Life System for     Peritoneal Dialysis (CLS PD). The extra-corporeally absorption of uremic toxins and certain     ions from the recirculated peritoneal fluid by the Purcart are evaluated together with the     achievement of a stable intraperitoneal osmolarity.   "
7323|NCT03190005|"     The investigators designed the following experiment to observe the pattern of administration     in vitro, which can be completely excluded liver enzyme cytochrome P450 metabolism under the     influence and observe the relevant P2Y12 receptor downstream signal changes, hope in the     above experiments, that the human body directly for the difference between the existence of     drug reactions exist.   "
7324|NCT03189992|"     Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge,     clinical diagnosis and treatment and curative effect evaluation in TCM. Same TCM Syndrome     for Different Diseases and Same Treatment for Different Diseases is one of the     characteristics of TCM syndrome differentiation and treatment.      This study is the TCM disease syndrome combination research baced on principles and methods     of system biology, which is through acquisition of primary hepatocellular carcinoma (HCC) and     colorectal cancer patients with TCM syndrome information, detection of clinical indicators     and genomic, proteomic, and metabolites changes, analyzing the correlation between TCM     syndromes and biological information, and revealing its biological material characteristics     and the molecular mechanisms of Same TCM Syndrome for Different Diseases;Developing and     implementing the program of TCM syndrome differentiation and treatment for HCC and colorectal     cancer to evaluate the efficacy of TCM syndrome based-treatment of HCC and colorectal cancer     with TCM syndrom scores, clinical and systems biological indicators, quality of life and     survival rate, and to revealing the mechanism of the Same Treatment for Different Diseases.   "
7325|NCT03189979|"     Background: Youth from low-income and minority families are disproportionately affected by     obesity and its complications. This study presented pilot work to develop and implement a     multi-component physical activity and healthy eating intervention at a Boys & Girls Club     (BGC) after school program.      Methods: Using a community-based participatory approach, BGC staff and academic researchers     developed intervention components informed by formative studies and based on a social     ecological theory framework. Components included healthy eating and physical activity policy     implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a     peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary     intervention efficacy was assessed through a single group, pre-post study design with     measured collected at baseline and 6 months.   "
7326|NCT03189966|"     The aim of the study is to evaluate the effectiveness of ultrasound-guided transversalis     fascia plane block (TFPB) and quadratus lumborum block (QLB) on post-operative analgesia in     pediatric patients with Developmental Dysplasia of the Hip (DDH)under going open reduction     surgeries（Salter acetabular osteotomy，combined with proximal femoral rotation osteotomy）.The     effectiveness of TFPB/QLB for perioperative analgesia in lumbar nerves (L1) innervated     surgery have been demonstrated in recent studies. However, this regional technique rarely     applied to children.The objective of our research is to assess the quality of postoperative     analgesia in pediatric patients who had received a preoperative TFPB/QLB for hip surgery.   "
7327|NCT03189953|"     In order to improve the sensitivity and specificity of pre-operative imaging localization of     foci in adult endogenous hyperinsulinemic hypoglycaemia (AHH) we aim to evaluate a novel     promising imaging compound targeting the glucagon-like peptide-1 receptor (GLP-1R),     68Ga-NODAGA-exendin 4. With the currently used imaging techniques, only about 70-80% of     insulin producing pancreatic neuroendocrine tumors (IPPNET) can be successfully visualized.     Therefore, we propose to compare GLP-1R PET imaging to the standard imaging techniques in     patients scheduled for surgical removal of the tumour. These highly relevant data will allow     us to interpret the benefits of GLP-1R-imaging over other imaging techniques for the     diagnosis of IPPNET in AHH patients. Since pre-operative localization of foci in AHH remains     challenging and frequently still leading to futile surgery or unnecessary partial     pancreatectomy, a more sensitive and specific imaging technique would be of great value.   "
7328|NCT03189940|"     This study aimed to investigate the effects of a mobile phone app linked to hospital     electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA).     Adults aged > 20 years with witnessed snoring or sleep apnea from a sleep clinic of a     tertiary center were prospectively enrolled, and the participats were randomized into app     user and control groups. The mobile app was designed to collect daily lifestyle data by     wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of     use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both     physicians and app users. Further lifestyle modification was encouraged on the basis of the     electronically collected data. In the control group, the lifestyle modification performed as     the usual practice. All participants underwent Watch PAT and body mass index (BMI)     measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters     of sleep related breathing were analyzed.   "
7329|NCT03189927|"     A non-randomized prospective clinical, pilot study in a single centre assessing the safety     and feasibility of the esophageal biodegradable covered stent for refractory benign     esophageal strictures with or without fistulae   "
9456|NCT03162289|"     The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a     supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality     of life, reduction of side effects and possible reduction in tumor progression.   "
7330|NCT03189914|"     This will be a Phase 1a/2b multicenter 2-stage study. Phase 1 will be conducted as a     dose-finding, open-label study of oral RX-3117 administered in combination with Abraxane® to     subjects with metastatic pancreatic cancer. After completion of the Phase 1 portion, a Phase     2a study will be conducted using a 2 stage, open-label design, of RX 3117 and Abraxane® in     combination to treat subjects with metastatic pancreatic cancer as first line therapy.   "
7331|NCT03189901|"     There are always poor outcomes in patients with acute myocardial infarction(AMI) combined     with elevated BNP/NT-proBNP level. An elevated BNP/NT-proBNP level highly indicates acute     heart failure(AHF).Levosimendan is recommended in many clinical trials of heart failure and     Chinese heart failure guidelines. As a result, the investigators form a hypothesis that when     patients with AMI combined with elevated BNP/NT-proBNP level are in conditions before AHF, to     use levosimendan may reduces the risk of heart failure and improve the outcome.   "
7332|NCT03189888|"     BACKGROUND: Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative     colitis, although is limited by costs and variability of results.   "
7333|NCT03189875|"     SPOCS is an international, multicenter, prospective observational cohort study with bi-annual     study visits over a 3-year follow-up designed to systematically describe the comprehensive     SLE patient-journey regarding clinical features, disease progression and treatment patterns,     SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU)     in a general population of moderate-to-severe SLE patients.   "
7334|NCT03189862|"     Physical inactivity in children is a major public health risk factor and a health objective     for the nation. This study aims to investigate the short- and long-term effects of a movement     and physical activity program - the Children Health and Motor Programs (CHAMP) on motor     competence, perceived motor competence, and physical activity. A secondary aim of this     project (i.e., Science of Behavior Change Administrative Supplement) is to examine the     immediate (pre- to post-test) effects of the CHAMP intervention on self-regulation and     associations between self-regulation and changes in motor competence, perceived motor     competence, and physical activity. The long term goal is to provide evidence-based movement     experiences during the early childhood years that promote and contribute to overall healthy     growth and development.   "
7335|NCT03189849|"     This study will be an observational study of children who attend summer camp at the Heartland     Farm Sanctuary (HFS). The investigators are exploring whether time-limited exposure to a     traditional farming environment will improve children's overall health and general     well-being.   "
7336|NCT03189836|"     This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and     anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with     rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.   "
7337|NCT03189823|"     In order to create insights in the effects of Motor cortex stimulation (MCS) on intractable     pain, an open observational study was started in 2003. The aim of this research is to:        1. to determine the clinical effectivity of MCS on pain intensity after 1 month, 1 year and          3 years of stimulation        2. to determine the clinical effectivity of MCS on QoL and daity medication intake after 3          years of MCS   "
7338|NCT03189810|"     The high prevalence of cannabis and other substance use disorders are a major barrier to     recovery in people with schizophrenia. Moreover, schizophrenia patients have significant     deficits in cognitive function, which may be exacerbated by cannabis use. Complicating these     problems is the lack of evidence-based treatments for co-morbid cannabis use disorders (CUDs)     in schizophrenia; there are no established pharmacotherapies. Therefore, this study is     investigating the effects of high-frequency (20Hz) repetitive transcranial magnetic     stimulation (rTMS) on cannabis use disorder and cognitive function in patients with co-morbid     schizophrenia/schizoaffective disorder. The proposed study would be the first randomized,     double-blind, sham controlled trial of rTMS in patients with schizophrenia and co-morbid CUD.     A total of N=40 schizophrenia smokers with co-morbid cannabis use disorder will be assigned     to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatment     for four consecutive weeks. All participants will receive weekly behavioral therapy for 4     weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham     rTMS for the treatment of CUD in schizophrenia.   "
7339|NCT03189797|"     This study will be conducted to evaluate The Effect of tailored preventive program on caries     incidence using International Caries Classification and Management System (ICCMS) at a follow     up periods of 3 and 6 months.   "
7340|NCT03189784|"     Ankle joint self mobilization.   "
7341|NCT03189771|"     effect of occlusal reduction on post-operative pain is evaluated after single visit root     canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible     pulpitis and apical periondontis   "
27172|NCT02930278|"     The purpose of this study is to explore the effect of preoperative hemotologic markers on     postoperative long-term and short-term outcomes for laparoscopic gastrectomy.   "
7342|NCT03189758|"     Sodium-adapted magnetic resonance imaging (23Na-MRI) studies have demonstrated that sodium     accumulates in certain tissues, including the skin and skeletal muscle, but may be     manipulated by lifestyle factors or therapeutic interventions such as a hemodialysis (HD)     session. This tissue sodium accumulation is increased with age and in the presence of certain     chronic diseases such as renal failure, and may contribute to the development of high blood     pressure. It currently not known what the impact of dietary sodium consumption has on tissue     sodium in HD patient's and on the subsequent risk of cardiovascular complications either     acutely or chronically. The University of Illinois' Biomedical Imaging Center recently     completed safety testing on a 23Na-MRI coil that they modified for measuring skin and muscle     sodium levels in the lower leg/calf that will be used for assessing the impact of dietary     salt restriction on tissue sodium levels.   "
7343|NCT03189745|"     This study will evaluate the immunogenicity, reactogenicity and safety of a booster dose of     MenACWY-TT vaccine administered 10 years after healthy subjects aged 11-17 years received     either MenACWY-TT vaccine (Nimenrix) or Mencevax ACWY   "
7344|NCT03189732|"     The aim of this study is to investigate whether metformin has inhibitory effect on     exercise-induced lipolysis in subcutaneous adipose tissue in healthy lean man. Ten healthy     lean mean will follow protocols consisting of 60 minutes of exercise on bicycle ergometer     combined with a) orally administered metformin and b) locally administered metformin into     adipose tissue and c) without metformin treatment. Microdialysis is used for assessment of     metabolites in situ in subcutaneous adipose tissue.   "
7346|NCT03189706|"     The purpose of this study is to find out whether an experimental drug called Hu3F8 can be     given with the chemotherapy drugs irinotecan and temozolomide and another drug called GM-CSF.     The investigators want to find out if this combination is safe and what effect it has on the     participant and the disease.   "
7347|NCT03189693|"     Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and     analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of     appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease     opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to     examine the analgesic effect of PVB on appendectomy in adult patients.   "
7348|NCT03189680|"     To determine the effects of an unusually highly intensity and individualized sensorimotor and     visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility,     and postural stability.   "
7349|NCT03189667|"     Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing     stenosis rates in dialysis arteriovenous fistulas (AVFs).   "
7350|NCT03189654|"     There are no investigations so far whether an application of positive pressure during     non-invasive ventilation might be a therapeutic option for transudative pleural effusion in     patients with heart failure. In view of the pathophysiological process with pleural effusion     resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation     might provide an improvement.      The aim of the present study is to investigate whether an additional non-invasive ventilation     therapy leads to an improved suppression of pleural effusion in heart failure patients.   "
7351|NCT03189641|"     The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol     eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary     arteries.   "
7352|NCT03189628|"     The purpose of this study is to observe whether the transplantation of autologous stromal     vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin     regeneration.   "
7353|NCT03189615|"     The purpose of this study is to assess the impact of mild to moderate hepatic impairment on     the pharmacokinetics of a single oral dose of Lu AF35700   "
7354|NCT03189602|"     The purpose of this study is to analyze the clinical manifestations, imaging features, and     prognosis-related factors of pulmonary artery (PA) involvement in Takayasu's arteritis (TA),     and to explore the early clinical features of PA involvement in TA patients.   "
7355|NCT03189589|"     GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the     treatment of inflammatory airways diseases. This is the first study using a new formulation     of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a     single dose of GSK2269557. Data derived from this study will inform on the PK profile and     systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be     randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of     GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing     0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study     will be carried out in 3 phases, including screening phase, treatment phase and follow-up     phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a     registered trademark of GlaxoSmithKline group of companies.   "
7356|NCT03189576|"     Circulating tumour DNA (ctDNA) is a promising tool when monitoring the residual disease in     colorectal cancer (CRC). Current staging procedures are insufficient to identify the patient     cohort at high risk, who might benefit from additional adjuvant therapy.      We will show that the assessment of ctDNA is a non-invasive approach and easily taken at     different time points via simple blood draw to monitor residual disease from the colorectal     cancer patients after primary surgery. Minimal residual disease could be used in the future     for individualized treatment decisions after primary surgery.   "
7357|NCT03189563|"     This is a phase IIa, first in human, randomized, double-blind, multicenter study to evaluate     the safety, tolerability and efficacy of DA-9805 at 45mg, 90mg versus placebo in subjects     diagnosed with early Parkinson's disease.   "
7358|NCT03189550|"     Multimodal perioperative care pathways have evolved into enhanced recovery after surgery     (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten     length of stay. This project will test the hypothesis that implementation of a multi-modal     ERAS perioperative care protocol in colorectal surgical patients will result in significantly     reduced perioperative morbidity and mortality.   "
7359|NCT03189537|"     The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people     having contact with sick people infected with influenza and other acute respiratory viral     infections   "
7360|NCT03189524|"     This phase I clinical study is to investigate the safety, tolerability and pharmacokinetics/     pharmacodynamics of BTK inhibitor BGB-3111 in Chinese patients with B-cell lymphoma, by     conducting in two stages, the first stage being the safety assessment of dose, and the second     stage being the dose expansion.      Part I: Safety evaluation - according to the results of preclinical toxicological trials and     the results of the phase I clinical study conducted in Australia and New Zealand, two     regimens of BGB-3111 320 mg daily (160 mg BID, administered in the morning and at night, or     320 mg QD) and 3+3 design is adopted for the assessment. The recommended dose and method of     administration of phase II clinical study will be determined according to the Part I results.      Part II: Dose expansion - this stage is to further evaluate the preliminary anti-tumor     effects of BGB-3111 in Chinese subjects with follicular lymphoma (FL) or marginal zone     lymphoma (MZL), approximately 20 subjects with relapsed or refractory follicular lymphoma     (FL) or marginal zone lymphoma (MZL) will be enrolled. The recommended Phase 2 dose will be     used in the Part II.   "
7362|NCT03189498|"     The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic     exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult     participants with various degrees of renal function (mildly, moderately, or severely     impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult     participants with normal renal function.   "
7363|NCT03189485|"     The purpose of this study is to measure the amount of a protein in the brain known as tau     using an imaging procedure called Positron Emission Tomography (PET/CT). 18F-AV-1451 is a     specialized radioactive PET imaging agent that is able to detect the presence of tau in the     brain. In this study, the investigator will use the 18F-AV-1451 to capture images of tau in     the brain. Findings from this study will likely provide insight into the mechanisms and     distinctions of age-related cognitive decline and that of very early Alzheimer's disease.   "
7364|NCT03189472|"     This is a double-blind randomized controlled pilot study to test the effects of     Remotely-Supervised (RS)-tDCS using a dorsolateral prefrontal cortex montage to ameliorate     fatigue and cognitive slowing in PD.      Fatigue and slowed thinking are very prevalent symptoms in people with Parkinson's disease     (PD). To date there are no concrete effective treatment available for either symptom. This     study will test transcranial direct current stimulation (tDCS) to ameliorate fatigue and     slowed thinking in PD. tDCS is a noninvasive brain stimulation technique that is low-cost,     relatively safe, and reproducible when conducted in repeat clinic visits.      Following procedures for our validated protocol, participants will receive training on the     use of study tDCS device and pre configured laptop computer. The device will be programmed to     deliver either active or sham tDCS (all study personnel and participants will be blinded),     and operated with unlock codes provided by the study technician daily to release one session.     Once trained, and following an initial in-clinic baseline tDCS tolerability test and initial     treatment session, participants will use the equipment to complete the remaining sessions     from their home using our tele medicine platform. Remote supervision will be provided using     HIPAA secure online video conference with the study technician following clearly-defined     operational procedures. Participants will be monitored to determine if any predefined stop     criteria are met using VSee software, a telemedicine software. Additionally, Team Viewer     software will allow study technicians to troubleshoot any computer issues, to initiate the     video conference on behalf of participants, and to remotely supervise the entire tDCS     session.   "
7365|NCT03189459|"     Advanced Parkinson's Disease is a debilitating, costly, and understudied condition. Improving     access to comprehensive, specialized, in-home patient care and caregiver support offers the     potential to minimize the downward spiral of morbidity and preventable healthcare     utilization. The aim of this proposal is to test whether and to what degree an     interdisciplinary home visit program, with and without peer mentoring for caregivers, will     improve patient- and caregiver-reported outcomes and reduce healthcare costs when compared     with usual care in advanced Parkinson's Disease.   "
7366|NCT03189446|"     The purpose of this study is to determine the progression-free survival of patients with     surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with     high-intermediate risk factors treated by vaginal cuff brachytherapy followed by     chemotherapy.   "
7367|NCT03189433|"     Ryanodex is being investigated as a potential adjuvant treatment for people suffering from     psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that     results mainly from the abuse of certain illicit drugs, most notably methamphetamine, and     related forms (MDMC or Molly; MDMA or Ecstasy). Ryanodex is approved for the treatment of     malignant hyperthermia in conjunction with appropriate supportive measures and for prevention     of malignant hyperthermia in patients at high risk and in this study, will be investigated     for the treatment of PDIT. The hypothesis of this study is that administration of Ryanodex as     adjuvant treatment to Standard of Care (SOC) will improve the clinical outcome compared with     SOC alone, in subjects with psychostimulant drug induced toxicity. Current SOC is defined as     body cooling and supportive measures.   "
7368|NCT03189420|"     Diffuse glioms are primary brain tumors characterized by infiltrative growth and high     heterogeneity, which render the disease mostly incurable. Advances in genetic analysis     revealed that molecular and epigenetic alterations predict patients´s overall survival and     clinical outcome. However, glioma tumorigenicity is not exclusively caused by its genetic     alterations. The crosstalk between tumor cells and the surrounding microenvironment plays a     crucial role in modulating glioma growth and aggressiveness. In this sense, to understand the     tumor microenvironment would elucidate potential treatment alternatives. The focus will be to     evaluate myeloid cells and cytokines levels.   "
7376|NCT03189316|"     Some subsets of lymphocytes are able to inhibit immune response and thus, could be used to     control auto-immune diseases and transplant reject. In mice, the main source of those     anti-inflammatory lymphocytes is the peritoneal cavity. No data are available in human. This     study aims at exploring the presence of those anti-inflammatory lymphocytes in human     peritoneal cavity and at determine how to expand those cells.   "
7377|NCT03189303|"     Prospective, global, multicenter study to assess cup position in THA. After written informed     consent has been obtained, study evaluations will be collected from the pre-op clinic visit,     the operative visit (including discharge), and 6, 12 and 52 weeks postoperatively.   "
7369|NCT03189407|"     Type 2 diabetes mellitus (T2DM) patients from our previous survey tend to co-administer     various herbs with their oral hypoglycemic agents (OHA). Some of these herbs are known to     possess antidiabetic activities. One of such is Moringa oleifera leaves.      The present study evaluated the effects of seven days, twice-daily administration of hot     water infusion of dried Moringa oleifera leaves on the steady state plasma concentrations of     Metformin, one of the most widely used OHAs using T2DM patients who have been on Metformin     for a period of not less than three months. The included patients had also been on Moringa     supplementation but had terminated the use of Moringa at least a month to the start of the     study.      Patients who had other comorbidities such as heart diseases, renal or hepatic impairments     were excluded from the study. The patients were recruited from Endocriniology clinic of the     Obafemi Awolowo University Teaching Hospitals complex, a tertiary hospital from southwest     Nigeria.      Each patient served as his/her control.   "
7370|NCT03189394|"     The proposed study is a randomized controlled intervention to reduce sexual risk for HIV     among HIV-negative concordant and HIV discordant gay couples. There are three arms of the     study: 1) the in-person experimental condition, PRIDE, 2) the online adaptation of the     experimental condition, ePRIDE, and 3) the time- and attention-matched in-person control     condition, Men's Health. Participants (N = 300 couples) will be randomized equally into one     of the three study conditions and assessed via surveys at baseline and at 3-, 6- and 9-months     after completion of the intervention sessions.   "
7719|NCT03184844|"     This is an exploratory experiment, aims to explore the effective and safety of thalidomide in     the treatment of TI to improve the hemoglobin level, improve the quality of life, reduce     blood transfusion, so as to avoid the adverse reactions caused by transfusion,60~100 patients     will be enrolled.   "
7371|NCT03189381|"     This trial is a pilot, Phase 2, sequential two-cohort study designed to test two de-escalated     whole brain radiation therapy (WBRT) dose levels and assess their ability to maintain     acceptable in-brain distant control. The WBRT dose would decrease as the study moves forward,     both in terms of absolute value and equivalent dose in 2 Gray fractions (EQD2) (as determined     by the linear quadratic radiobiological model). The absolute value of the simultaneous     integrated boost (SIB) dose will change with each dose level because the number of fractions     delivered will depend on the WBRT dose. As such, the SIB dose will be manipulated such that     the EQD2 will remain essentially equivalent despite the difference in the number of fractions     delivered. This design will ensure that the only variable is the change in WBRT dose.      The concept is that WBRT with SIB would be expected to maximize both local and in-brain     distant control as has already been shown in studies exploring WBRT with SRS boost. However,     by itself WBRT with SIB does not address the concern over neurocognitive outcomes. Therefore,     investigators hypothesize that there is a lower WBRT dose threshold that will maintain     acceptable in-brain distant control, particularly in the setting of a SIB to gross lesions to     maintain treated lesion control. In addition, lower overall brain dose (including lower     hippocampal dose without specific hippocampal avoidance) may potentially improve     neurocognitive function. Investigators are also interested in evaluating treated lesion     control, overall survival, neurocognitive sequelae of therapy, quality of life, performance     status, and adverse effects of therapy. Biomarker identification for potential correlative     circulating tumor DNA and microRNA is an exploratory endpoint to generate data for future     prospective evaluation.   "
7372|NCT03189368|"     To perform a comparative study of multi-site left ventricular pacing and cardiac     resynchronization therapy effects on ventriculoarterial coupling and energy efficiency of the     failing heart   "
7373|NCT03189355|"     With a prevalence of more than 15% in ICU, septic shock today represents a real public health     problem and remains the leading cause of mortality in ICU. Undernutrition is characterized by     an alteration of the body composition and in particular by a loss of muscle mass. In     intensive care, there are indirect elements suggesting a link between loss of muscle mass and     prognosis.      Muscle mass results from a balance between the pathway of proteolysis and that of protein     synthesis, depending on many factors, not one of the most important are insulin. The protein     PTP1B (Protein Tyrosine Phosphatase 1B), by the dephosphorylation of its numerous substrates,     constitutes an endogenous regulator of numerous intracellular signaling pathways, including     that of insulin. PTP1B could play a role in the protein synthesis abnormalities observed     during sepsis leading clinically to impaired body composition including muscle body mass.     Therefore, we propose to study the association between PTP1B and loss of muscle mass in     patients in sepsis in resuscitation.      The intestinal barrier plays an essential role in protecting against microbial luminal flora     and the phenomenon of bacterial translocation. Zonulin is one of the major regulators of     tight junctions, important actors in the intestinal barrier function. The increase in plasma     zonulin levels, greater than 0.6 ng / mg, is directly correlated with increased intestinal     permeability (16). However, elevation of plasma zonulin has never been evaluated in septic     resuscitation patients. This is why we propose the evaluation of the association between     plasma zonulin and the loss of muscle mass in these resuscitation patients.   "
7374|NCT03189342|"     Dual task training has been shown to reduce the risk of falls more than single task training.     However, there have been no studies which compared the effects of single task training, dual     task training and asynchronous cognitive, balance exercise training during same day on the     risk of falls among healthy older individuals. Therefore, the aim of this study was to     investigate differences among the effects of single task training, dual task training and     exercise-cognitive activity combined training on balance and gait performances and fall risk     in elderly at risk of fall.   "
7375|NCT03189329|"     The investigators measured changes in cerebral oxygen saturation (rSO2) and MMSE scores after     retrobulbar block performed with levobupivacaine and lidocaine in patients undergoing     vitreoretinal surgery.A total of 66 patients over the age of 60 undergoing vitreoretinal     surgery with a total duration of less than 1 hour were included in this prospective,     double-blinded study. The patients were randomly divided into two groups: group L (5ml, 2%     lidocaine) and group LB (5ml, 0.5% levobupivacaine). Bilateral rSO2 measurements were     recorded before the retrobulbar block and at 1-5 minutes post-block, during the procedure,     and at 10-40 minutes post-op. MMSE was performed preoperatively and postoperatively in order     to evaluate short term cognitive function. Sensory and motor block durations, pain, akinesia     and conjunctival feeling scores, patient-surgeon satisfaction, and complications were also     recorded.   "
7378|NCT03189290|"     The purpose of this prospective research study is to determine the best way to manage     post-operative pain after a total hip arthroplasty. Currently, there is no standard of care     for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first     described by Blanco in 2007, is a promising technique in this indication: recently, there is     a growing evidence for the use of the QLB as an alternative technique for pain management     after hip surgery.   "
7379|NCT03189277|"     This cross-sectional study, utilizing two sets of questionaire designed for patients and     physicians respectively, aims at the epidemiology, the clinical features, and the current     status of evaluation and management of lung cancer related pain in 20 participating hospitals     in Northern China.   "
7514|NCT03187522|"     This is an EU sponsored trial and independent of the US trial registered under     Clinicaltrials.gov ID NCT02009644.      The purpose of this registry is to gather clinical data on the safety and performance of the     TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part     of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.   "
7380|NCT03189264|"     Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure considered as the     treatment of choice for the management of large-scale and fully-formed kidney stones.This     procedure has a 5% risk of complications including bleeding, the lesion of the collecting     system, the risk of urinary infection and bacteremia. New surgical tools such as dilatation     of the nephrostomy tract with mechanical dilatation contribute to the reduction of these     risks, together with an improvement in the operative times and a lower rate of complications.      At present there are multiple scales measuring the lithiasic morphology (Guy, the STONE     nephrolitometry score system and the nomogram of the Office of Clinical Investigation of the     Endourology Society - CROES) which allow to evaluate the degree of complexity of the stone,     the possibility of residual stones and the risk of complications. These tools allow us to do     a better analysis of the risk factors of the patient who will be taken to this type of     endoscopic procedure in order to decrease morbidity and complication rates.      Hypothesis:      The use of pneumatic dilators during percutaneous nephrolithotomy reduces the rates of     intraoperative and postoperative complications, which would have an impact on hospitalization     times and surgical success for the management of renal stone.   "
7381|NCT03189251|"     Perform an exploratory analysis of association between consumption of high excess free     fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple     juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.   "
7382|NCT03189238|"     Female Orgasmic Disorder (FOD) is defined as a female sexual disorder with the presence of     the following on all or almost all (75%-100%) occasions of sexual activity:        1. Marked delay in, marked infrequency of, or absence of orgasm        2. Marked reduced intensity of orgasmic sensations.        3. The absence of orgasm must cause personal distress (bother) in order for these symptoms          to be considered a disorder. (for example, women who are not very bothered by their lack          of orgasm do not have FOD).      Symptoms must have been present for at least 6 months and are not better explained by a     mental disorder or because of a relationship problems or other significant stress in the     participant's life and not due to effects of substance abuse or new medications or other     medical conditions.      Approximately one in twenty women have FOD and it is the second most frequently reported     sexual problem in American women. FOD can either be lifelong (primary) or acquired     (secondary).      There are no currently FDA approved treatments or devices for FOD. Therefore, common     off-label treatments include psychotherapy/sex therapy, hormone therapy, and medications that     increase blood flow to the genitals.      Platelet-rich plasma (PRP) is a platelet concentrate that may help to speed up tissue     healing, without serious side effects, in some medical conditions. It has been tried as     treatment for diabetic foot ulcers, muscle injury, tendon injury, and in a variety of     cosmetic procedures. The only condition for which there are high-quality data and clear     demonstration of effectiveness is arthritis of the knee. It is also apparent from the     majority of published studies that PRP therapy has minimal risk of scar tissue formation or     significant bad side effects.      It has been suggested by many scientists that in some women FOD may be caused by decreased     clitoral and genital blood flow secondary to blockage in the small blood vessels going to the     clitoris (similar to that seen in erectile dysfunction (ED) in men) and/or diminished nerve     conduction (also as seen in ED). PRP activates cells to develop into new tissue—nerves,     collagen, and blood vessels. As such, PRP may potentially reverse the changes responsible for     FOD. In addition, it has been shown that improved sexual function in women is highly linked     with increased blood flow through the clitoris. One component of PRP is known to cause growth     of new blood vessels. Therefore, the investigators anticipate PRP injections may potentially     improve blood flow through both the clitoris and the tissue around the urethra, thereby     improving sexual function and decreasing FOD.      In addition, it has been shown that women who easily achieve orgasm are more likely than     women with FOD to have a larger clitoris and a clitoris positioned closer to the vaginal     wall. Since PRP has been shown to increase connective tissue, injection of PRP into the     clitoris may potentially enlarge the clitoris and may bring the clitoris closer to the     vaginal wall, thereby improving orgasm.      There are some reports that physicians using the PRP as an injection near the urethra and     clitoris have seen some patients with improvement in FOD after the injections. This is the     first study that uses an objective comparative study to find out if this treatment works or     not.   "
7383|NCT03189225|"     This study is to evaluate accuracy between product platforms in the hands of users, comparing     capillary to venous response vs YSI reference instrument as well as the local hospital     analyser.   "
7384|NCT03189212|"     The purpose of this study is to determine whether a telemedicine follow-up visit at the NYU     Langone Transplant Institute is a feasible and acceptable alternative to a traditional     in-center follow-up visit.   "
7385|NCT03189199|"     The purpose of this study is to make a cohort event monitoring to see whether and how     Dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions   "
7386|NCT03189186|"     Patients will undergo a screening process as per standard of care to identify disease type     and severity. Careful history and physical examination will also take place to rule out major     heart, lung, or kidney disease and pregnancy that may affect how they will respond to the     treatment. Patients with advanced (stage II and above with multiple tumors or tumors within     vessels) and metastatic Renal Cell Carcinoma will be first treated with cryoablation on a     large primary tumor and then given 200 mg pembrolizumab every 3-weeks 3 cycles , followed by     partial/radical nephrectomy. Pembrolizumab is a biologic drug that adheres to the cell death     receptors on white blood cells preventing there death and leading to an increased immunologic     response. Cryoablation will be used in these patients to initially trigger and immune     response to cancerous cells that is then magnified by the drug. After the surgery, patients     will resume pembrolizumab for additional 5 cycles or up to a total of 2 years if a partial     response is observed at the discretion of the treating medical oncologist or urologist until     complete tumor remission, disease progression, unacceptable toxicity, patient refusal, or     patient death due to any cause.   "
7387|NCT03189173|"     The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances     and supplemental inspired oxygen. The following aims will be tested:      Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity     (apnea-hypopnea index) in patients using an oral appliance.      Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral     appliances versus supplemental oxygen versus both treatments in combination. We will test     whether responders to oral appliances have distinct pathophysiological characteristics     compared with oxygen responders.   "
7388|NCT03189160|"     This study aims to explore the optimal dose of pegylated recombinant human growth hormone     (PEG-rhGH) injection to treat children of Turner syndrome (TS), preliminarily evaluate its     safety and efficacy and provide scientific and reliable evidence for the medication dosage in     Phase 3 clinical trial.   "
7429|NCT03188627|"     Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor     airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even     death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by     recent clinical methods so far. This study intends to carry out a single-centered and     non-randomized phase I/II clinical trial with concurrent controls to investigate whether     bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial     basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful     characterization, expanded cells will be transplanted autologously into the lesion by     fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by     measuring the key clinical indicators.   "
7569|NCT03186807|"     The aim of this study is to evaluate the normal development of cerebral cortex with     quantitative measurement in low risk pregnant women   "
8876|NCT03169725|"     The purpose of the study is to evaluate safety and immunogenicity of inactivated     poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose     of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.   "
7389|NCT03189147|"     The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC     tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears     simultaneously due to the high likelihood of prolonged postoperative immobilization,     stiffness and poor clinical outcomes. The current standard care interventions include     debridement, biceps tenotomy or tenodesis rather than surgical repair of SLAP tears. Simple     debridement is a low cost and time-saving procedure that has the advantage of maintaining the     anatomy of the long head of biceps (LHB), a muscle that acts as an active depressor of the     head of the humerus in patients with RC tears. Biceps tenotomy is also low cost and     time-saving; however, since the LHB is released from its attachment in the shoulder joint,     the anatomy is not preserved and results in decreased strength and possible development of a     'Popeye' deformity. Biceps tenodesis has higher costs and time than the other two approaches,     but has the advantage of preserving the LHB anatomy and power, and a lower possibility of     developing complications. Finally, labral repair has the highest costs and associated     surgical time and may lead to increase stiffness after surgery, particularly in patients over     45 years old.      Currently, the standard care of the surgeons involved in this study is to use either     debridement or biceps tenodesis to address labral lesions in patients undergoing surgery for     their RC tear. Based on the current evidence and current practice in our facility, we aim to     compare the efficacy of tenodesis versus debridement in patients with combined RC tear,     degenerative labrum (SLAP tears) and a normal biceps tendon.   "
7390|NCT03189134|"     The investigators propose to translate confocal microscopy for use during open heart surgery.     This tool will help discriminate between various types of tissues in the heart during     surgery. One of the most feared complication after heart surgery is heart block. This     flexible fiberoptic confocal microscope will help discriminate between the various types of     tissues in the heart and thus help avoid injury to the conduction tissue during surgery.   "
7553|NCT03187015|"     The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of     Midazolam.      The primary objective is to evaluate the effect of a single oral dose of entinostat on the     pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects.      The secondary objective is to evaluate the safety and tolerability of combined administration     of entinostat and midazolam in healthy subjects.   "
7392|NCT03189108|"     Background:      Researchers want to study fluids and blood of people with cancer. The fluids are from the     abdomen and around the lungs. Studying these might help researchers learn about the biology     of cancer. This may lead to better ways to treat cancer.      Objectives:      To study the biology of cancer.      Eligibility:      Adults 18 and older with malignant solid tumors.      Design:      Participants will be screened with medical history, blood tests, and confirmation of     diagnosis.      Participants will have samples taken at regularly scheduled procedures. Fluids from the     abdomen and/or lungs will be taken as part of the procedures. Blood will be taken separately.      Participants may be asked to give more samples at future procedures.   "
7393|NCT03189095|"     Project WOWii examines how useful and effective an online format is for helping people with     SCI get more exercise over 4 months. Study participants will meet over Skype weekly for 16     weeks and work through weekly online modules to start and stick with an accessible and     individualized exercise program. Participants will be compensated for their time to attend     fitness testing and complete surveys before and just after the 16-week program.   "
7394|NCT03189082|"     The purpose of this study is to evaluate the efficiency of the intradermal injection of     botulinum toxin in lower face rejuvenation. The study will also compare this intervention     with the Nefertiti Lift intramuscular injection technique.   "
7395|NCT03189069|"     The primary purpose of this study is to evaluate the risk of major bleeding and     stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve     Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with     apixaban, dabigatran, rivaroxaban, or warfarin.   "
7396|NCT03189056|"     Chagas disease is one of the most neglected vector-borne infectious disease worldwide. The     first decades following the discovery of the pathology drove an international research     enthusiasm, mainly concentrated on understanding the typical cardiac and digestive forms.     Recently, research have been focused on vector control, which has been a huge success, at the     price of neglecting the patients who already presented fixed and severe organic lesions due     the chronic phase of the illness.      This study focus on a rarely studied aspect of this pathology: the involvement of the lower     urinary tract and it's symptomatology in adults suffering from Chagas chronic disease.      Various studies have assessed the involvement of the lower urinary tract in chronic Chagas     disease, the vast majority of them being on the animal model or very ancient human studies     mainly on cadaveric specimen, the first of them being the primary description of Koeberle in     1963.      Human symptomatology deriving from bladder, ureteral and urethral chronic chagasic lesions     are yet widely unknown, and only a few Brazilian and Mexican studies have intended to     describe the clinical and urodynamic presentation of these patients.      The aim of this study is to assess the prevalence of urinary disorders in chronic chagasic     patients and to describe their symptoms, through a complete clinical, ultrasonographic and     urodynamic description.   "
7397|NCT03189043|"     This is a controlled open label efficacy study of Aionx antimicrobial surface for the     prevention of healthcare-associated infections.   "
7398|NCT03189030|"     This study will evaluate the safety and tolerability of a personalized live, attenuated,     double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal     cancer.   "
7399|NCT03189017|"     This is a single center, randomized, double-blind, placebo-controlled, dose escalation study     in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of ICP-022 following oral single and multiple escalating dose     administration.   "
7400|NCT03189004|"     1. Burden:           In global perspective, it is estimated that the lives of 150,000 women could be saved          each year worldwide with access to sufficient family planning services. It is indicated          that only 26 percent women received four or more antenatal care (ANC) visits during          their pregnancies, while 67.7 percent received at least one ANC during their pregnancies          which are the great challenges for ensuring safe motherhood in the country. As a part of          safe motherhood, it is estimated that only 28.8 percent deliveries are being conducted          in health facilities in the country. In case of postnatal care (PNC), from 2008 to 2010,          only 27 percent of women received PNC for their last deliveries from a medically-trained          provider within two days of their delivery. Despite the tremendous success of expanded          programme on immunization (EPI) in Bangladesh, a substantial number of children are not          fully vaccinated under EPI as data shows 82 percent were fully vaccinated by the age of          12 months.        2. Knowledge gap:           Use of technology for covering all or major components of primary health care (PHC) is          yet to be developed and tested in Bangladesh. Further, no such initiative has yet been          taken focusing community clinic (CC) to ensure equity of services in Bangladesh.        3. Relevance:      At present in Bangladesh, the CCs cater the services on family planning, maternal neonatal     and child health (MNCH), health education for the rural people by using e-health strategy as     the community health care provider (CHCP), newly recruited staff of community clinic are     equipped with internet connected laptop service. So, updated technology for updating     information, follow up and referral in primary health care can be used to increase the     utilization of health services.      Hypothesis (if any):      Use of smart phones by community level healthcare providers will increase utilization of     reproductive health (RH) and family planning (FP), MNCH, integrated management of childhood     illness (IMCI), EPI and other PHC services at rural communities in Bangladesh.      Objectives:      To develop and test a mechanism as well as assess the impact of mHealth strategy to improve     RH and FP, MNCH, IMCI, EPI and other PHC services in rural communities of Bangladesh.      Methods:      The service delivery personnel who are providing the services to the community people at     different levels (community clinic, union health and family welfare centre, upazila health     complex) will be equipped with smart phones having the facilities for text messages, voice     messages as well as internet and data capturing. Training on handling of the smart phones,     data capturing and monitoring will be provided to service providers in each upazila. They     will be trained to input, edit, verify and monitor the data on different services through the     software installed in their smart phones. The community clinic management and support groups     will be oriented and motivated on mobile phone based registration, notification and referral     to the health facilities.      Outcome measures/variables:      This will be a quasi-experimental pre-post design study and evaluation will be done through     comparing antenatal care (ANC), postnatal care (PNC), and contraceptive prevalence rate (CPR)     and EPI coverage before and after its implementation in the study versus comparison areas.     The study will be conducted over a period of 30 months.   "
7401|NCT03188991|"     This study will evaluate intracystic NanoPac® (Sterile Nanoparticulate Paclitaxel)     administered via endoscopic ultrasound-guided fine needle injection (EUS-FNI) in subjects     with mucinous cystic pancreatic neoplasms.   "
9015|NCT03167905|"     Postnatal depression affects about 10-15% of women after childbirth. Approximately 3-5% of     women experience a moderate-to-severe depression that requires medical attention. This study     aims to investigate the implication of pain relief choice in reducing the postnatal     depression of women who deliver their babies.   "
7402|NCT03188978|"     Primary failure is the most common complication of newly created arteriovenous fistulas     (AVFs) and an important contributor to end stage renal disease (ESRD) patients' morbidity and     mortality. Recently, the investigators have found that high intensity atorvastatin (40     mg/day) reduces AVF primary failure significantly when compared to other statins or no statin     treatment in three separate prospective and retrospective studies done in collaboration with     the University of Miami. Based on these findings and considering the necessity for a therapy     to improve AVF maturation rates, the investigators propose the realization of a feasibility     pilot double blinded randomized controlled trial (RCT). In this study, a total of 50 patients     will be randomly allocated to receive high intensity atorvastatin (40 mg daily) or placebo     starting at two weeks before surgery and until the end of the observational period (6 weeks     after surgery). Present trial will reveal crucial feasibility information such as the     appropriateness of the eligibility criteria, patient recruitment and retention rates,     compliance, adverse events, efficacy of patient follow-ups, and readiness of the facilities     and involved personnel; while having as a secondary endpoint the predictive measurements of     diameter and AVF blood flow 6 weeks after fistula creation useful for the estimation of the     probable effect of proposed intervention. Here, the investigators aim to pave the way for a     future multicenter Phase II RCT seeking to prove the efficacy of atorvastatin therapy as a     perioperative intervention to reduce AVF primary failure.   "
7403|NCT03188965|"     The ATR(ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for     the treatment of patients with advanced solid tumors and lymphomas. The purpose of the     proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the     maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further,     the response of the cancer to the treatment will be determined.   "
7404|NCT03188952|"     1. A total of 40 volunteer patients will be assigned in this study.        2. All patients will be randomly selected with variable caries risks .        3. For each patient The Examiner will use Two screening methods used in caries detection ,          where D1 represents ICDAS index and D2 represents ICCMS index which are used by each          examiner for each patient.        4. Each examiner will record the dental findings using the visual- tactile assessment          method .The visual-tactile assessment method includes the use of mirror, probe under          good illumination condition        5. After full caries assessment in the 1st visit , All patients will receive full treatment          and oral hygiene control .        6. After 6-months follow up re-assessment of same patients will be done by same Examiners .        7. The data of each examiner will be collected, and then the repeat-ability and the          reproducibility of each method as well as the inter- and intra-operator agreement will          be evaluated using the kappa statistics             -  Number of visits & follow up period: There will be 2 visits and 6-months follow up               between 2 visits.             -  Direct benefit of the research to the human volunteer:To get the most appropriate               treatment plan .             -  Scientific Value and social benefits:obtain better information quality and support               Dentist Discussion making.             -  Expected risk to human subjects:: the ordinary side effects associated with any               restorative treatment and no of the study variable has side effect on the patient               and in case of any side effect due to the restorative treatment , the participant               will directly contact the operator.   "
7405|NCT03188939|"     Supraclavicular block of brachial plexus is a type of regional anesthesia sometimes employed     as an alternative to general anesthesia for surgery of the forearm. Many approaches have been     described for ultrasound-guided supraclavicular block of the brachial plexus , Double-     injection technique , single-injection and intra- cluster-injection technique. In intra-     cluster-injection technique.The comparison between the 3 techniques may allow detecting the     most beneficial one. the investigators hypothesized that intra-cluster-injection technique     will be associated with more rapid onset, longer duration and the least complications.     (because the trunks and divisions of the brachial plexus are relatively close as they travel     over the first rib, the onset and quality of anesthesia will be faster and complete) Methods     : This study will be conducted at kasr al ainy Hospital Cairo university After obtaining     ethics committee approval and written informed consent 36 patients (who will undergo surgery     for forearm)included in the study classified into three groups Gs single injection technique     ,Gic intra- cluster injection technique, Gd double injection technique After block will be     done, a second investigator will examine the patient for sensory and motor block (every 10     minutes for 30 minutes) and for occurrence of complications. The patient will be ready for     surgery when the score ≥14 point. At this point the onset will be determined and so the     patient can be transferred to the operating room .      If the patient experienced anxiety, propofol infusion (80-250 ug/kg/min) can be started. If     the patient experienced pain during surgery the block considered failed and induction of     general anesthesia should be started.      After end of the surgery the second investigator will continue to assess the patient for post     operative pain every one hour for 24 hours to determine duration of the block.   "
7406|NCT03188926|"     To provide treatment guidelines for patients with long bone metastatic disease based on     observational study and to propose an algorithm to guide orthopedic surgeons in     decision-making for these patient.   "
7407|NCT03188913|"     Prospective observational study in which FXIII levels and coagulation tests and cicatrization     are measured during the 30 days after the thermal trauma.   "
7408|NCT03188900|"     The aim of the study is to setup a collection of maternal plasma and serum from patients with     preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on     extra-corporal removal of sFlt-1   "
7409|NCT03188887|"     TIGER study (Treatment of IgA nEphropathy according to Renal lesions) is a prospective openly     randomized controlled study.      The main objective is to evaluate the efficacy of early corticotherapy + RAS blockade (versus     RAS blockade alone) after two years of evolution in IgAN patients with severe histological     lesions The study will include 122 IgAN patients, it is scheduled to start in september 2017.   "
7410|NCT03188874|"     This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute     myeloid leukemia.      Investigator's sites: 40 sites in Germany.      Primary objectives:        -  Identification of epidemiological data on AML: age, prognostic factors and subgroup          distributions. Incidence and age distribution are compared with the data of          population-related tumor registry.        -  Evaluation of the most important patient-relevant clinical endpoints (outcomes):          relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence          of relapse (CIR) and overall survival (OS)        -  Documentation of treatment strategy   "
7411|NCT03188861|"     EMASPOT assesses the prevalence and impact of mental health conditions in multimorbid     emergency patients with cardiac ACSC on transsectoral utilisation of health care services.   "
7412|NCT03188848|"     This is a randomized, double-blind, placebo-controlled, dose finding study evaluating the     safety, pharmacokinetics and pharmacodynamics of subcutaneously injected BPI-3016 in Chinese     healthy subjects.   "
7413|NCT03188835|"     Activating brown and beige adipose tissue (herein described as BAT) has been recently     recognized as a potential means to increase energy expenditure and lower blood glucose,     however, BAT activity appears to be reduced with obesity, aging or Type 2 Diabetes (T2D). BAT     has the unique capability to burn large amounts of sugar and fat and effectively dissipate     this energy as heat due to the expression of uncoupling protein 1 (UCP1) which is controlled     by a thermogenic gene program of transcription factors, co-activators and protein kinases.     Thus, enhancing the thermogenic gene program may be beneficial for treating obesity and T2D.     Despite the importance of BAT in regulating metabolism our understanding of the factors which     suppress its metabolic activity with obesity, aging and T2D are largely unknown. Recently, it     was shown that peripheral serotonin, which is regulated by the tryptophan hydroxylase 1     (Tph1), is a negative regulator of BAT metabolic activity. In addition to serotonin, other     studies have indicated that pro-inflammatory stimuli may also inhibit BAT metabolic activity.     These data suggest that reduced activation of BAT may be due to increases in peripheral     serotonin and inflammation. Importantly, the gut microbiome has recently been recognized as     an important regulator of serotonin and inflammatory pathways suggesting the observed effects     of the microbiome on obesity, T2D may be mediated in part through reductions in BAT activity.      One mechanism by which the environment may impact BAT activity and the thermogenic gene     program over the last 3 decades involves changes in our food supply as result of changes in     agricultural production (chlorpyrifos, glyphosphate) and the addition of food additives     (fructose). These agents have been reported to alter inflammation, serotonin metabolism and     the gut microbiome indicating a potential bimodal (direct and indirect via the microbiome)     mechanism by which they may alter the thermogenic gene program and contribute to chronic     metabolic disease. Thus, our overarching hypothesis is that environmental agents and     additives related to food production may contribute to the reduced metabolic activity of BAT.     The objective is to identify and characterize how food production agents and additives reduce     the metabolic activity of BAT.   "
7414|NCT03188822|"     The purpose of this study is to compare how two different post-surgical treatments that both     deliver steroids to the frontal sinus opening affect your healing after frontal sinus     surgery.   "
7415|NCT03188809|"     After total knee prosthesis surgery, in the first postopertive days, serious pain complaints     occur in the patients and this causes many problems, especially mobility limitation. For this     reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee     surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in     the forefront, peripheral nerve blocks are frequently preferred due to complications related     to central nerve blocks. Femoral nerve block and adductor channel block are the preferred     peripheral blocks for total knee prosthesis. Since early mobilization after total hip     prosthesis is very important, it is aimed to provide sufficient analgesia by making less     motor block. Previous studies have shown that adductor channel block provides similar     analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the     risk of falls are not yet clear, although it is estimated to be in the positive direction.     Again, previous studies have compared single doses and infusion doses but no repeated bolus     doses. Repeated bolus doses have been shown to be more effective in studies in which adductor     channel catheters have been introduced to date to compare infusion and recurrent bolus doses.      investigators aimed to compare the effects of repeated bolus doses with femoral nerve     catheter and adductor channel catheter on postoperative pain and muscle strength in patients     undergoing total knee replasment under spinal anesthesia in this study.   "
7416|NCT03188796|"     In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill     patients, there was no benefit regarding the primary endpoint hospital length of stay.     However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had     significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, HR 0.52     (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of     severely vitamin D deficient critically ill patients is a promising and inexpensive     intervention that requires confirmatory multicenter studies.      To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever     demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials.     In case of benefit, vitamin D treatment in critically ill patients could be immediately     implemented worldwide.   "
7417|NCT03188783|"     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of     single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.   "
7418|NCT03188770|"     The purpose of this international, multicenter service review is to describe and compare     ventilation management in patients at risk of acute respiratory distress syndrome (ARDS)     versus patients not at risk and patients with established ARDS, and to ascertain whether     certain ventilator settings and ventilation parameters are associated with pulmonary     complications or development of ARDS after start of ventilation in patients in intensive care     units (ICUs) in Asian countries.      Participating centers will include adult patients undergoing mechanical ventilation in the     ICU during a 28-day period. Patients' data will be collected during the first 7 days in the     ICU, or until ICU discharge. Follow up is until ICU discharge. The primary outcome includes     two main ventilator settings, i.e., tidal volume and the level of positive end-expiratory     pressure. Secondary endpoints are development of ARDS in patients without ARDS at the onset     of mechanical ventilation, worsening of ARDS in patients with ARDS at the onset of mechanical     ventilation, pulmonary infection, other pulmonary complications, need for tracheostomy,     duration of ventilation, length of ICU stay and ICU mortality.   "
7419|NCT03188757|"     There are going to be 20 adoescents, 5-10 years after onset of T1D, aged 12-20 years, on     insulin pump. They are going to have MRI of the head in euglycaemic and hyperglycaemic state.     During both MRI, they are going to preform Flanker test, Tower of London test and Spatial     memory test. We are also going to check the response of inflammation markers and oxidative     stress marekers in blood durin hypreglycaemia.   "
7430|NCT03188614|"     Fluid resuscitation is important in shock therapy, but the choice of fluids, especially the     choice of crystalloid is under debate. It is said that normal saline is related to     hyperchloremia， which might lead to acute kidney injury. Thus the hypothesis of the study is     to explicit whether balanced salt solution could reduce the incidence of acute kidney injury     when compared with normal saline.   "
7431|NCT03188601|"     Create a personalized time and context curve of patient circulating α1-antitrypsin (AAT)     levels and functions before hematopoietic stem cell transplantation and throughout     progression into GVHD.      PRIMARY ENDPOINT 1. Serum AAT levels and activity, before myeloablative preconditioning, as     well as on days (-3),0,7,14,28 from HSCT and every 21 days thereafter.      SECONDARY ENDPOINTS 1. Correlation between AAT patterns and:        -  Circulating immune cell activation profiles on day of ablation, 28 days from HSCT and          once GVHD is diagnosed.        -  Patient survival        -  Liver function tests        -  GVHD grade: skin manifestations, weight, GI and liver histopathology        -  Graft-versus-leukemia effect   "
21113|NCT03009227|"     The purpose of this study is to determine wether D3 lymph node dissection gives superior     oncological outcomes compared to standard D2 lymph node dissection in colon cancer   "
7420|NCT03188744|"     Introduction: Pelvic floor muscle dysfunctions (PFMD) represent a major public health problem     manifesting through lower urinary tract symptoms (LUTS), anorectal and sexual dysfunction in     the general female population. A large part of the research published in this subject covers     non-cancer patients. Aim: This study aims to verify the prevalence of PFMD in patients     diagnosed with cervical cancer (CC). Secondly, it is aimed to verify the presence of a     multiprofessional approach before, during and after cancer treatment; to evaluate the reasons     for not seeking treatment for PFMD; to evaluate the effect of a pelvic floor muscle training     (PFMT) in women with PFMD and to assess quality of life (QoL). Methods: Patients with a     diagnosis of CC, of any stage, histology and grade, accompanied by the Oncology Gynecology     Service of the Clinic Hospital of Medical School of Ribeirão Preto of University of São Paulo     will be studied in the period between 2004 and 2014. For the analysis of the prevalence of     PFMD will be applied the Discomfort Questionnaire on the Floor Pelvic (PFDI-20) for     evaluation of pelvic organ prolapse (POP) complaints, anorectal symptoms and urinary     incontinence, and the Sexual Questionnaire for Urinary Incontinence and Pelvic Organ Prolapse     (PISQ-12) for evaluation of sexual function. Both questionnaires have already been validated     for the Portuguese language and are specific for women with PFMD. A structured questionnaire     developed by the researchers will question the presence of a multiprofessional approach     before, during and after cancer treatment. This same structured questionnaire still contains     questions that address the possible reasons why patients did not seek specialized treatment     for PFMD. The Pelvic Floor Impact Questionnaire (PFIQ-7) will also be applied to assess the     impact of PFMD on QoL, daily life activities and emotional health. For the evaluation of     global QoL, the EORTC QLQ-C30 questionnaire and its specific module for patients with CC,     QLQ-CX24, will be used. All questionnaires proposed will be applied by telephone. Patients     evidenced with PFMD through the application of the proposed questionnaires will be invited to     participate in a PFMT program, with sessions held once a week with a duration of 45 minutes     each during the period of 10 week. The PFMT will be supervised by a single physiotherapist.   "
7421|NCT03188731|"     The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV)     infections in pregnancy and congenital malformations. We will estimate the absolute and     relative risks of congenital malformations and other adverse outcomes of pregnancy among     women who become infected with ZIKV during pregnancy compared to uninfected pregnant women,     also leading to further validation of the Congenital Zika Syndrome.   "
7422|NCT03188718|"     Validation study of a novel sleep Device compared to a traditional sleep study.   "
7423|NCT03188705|"     This study builds, in part, upon preliminary results generated as part of the     Pharmacogenomics Anti-Platelet Intervention (PAPI) Study (NCT00799396). The purpose of this     investigation is to assess the impact of genetic variation in the carboxylesterase 1 (CES1)     on response to clopidogrel as well as dual antiplatelet therapy (i.e. clopidogrel and     aspirin), as assessed by ex vivo platelet aggregometry, in healthy Amish individuals. The     investigators hypothesize that participants who carry alleles that modify the activity or     expression of CES1 will have altered response to clopidogrel as well as dual antiplatelet     therapy.   "
7424|NCT03188692|"     The purpose of this study is to evaluate the safety and efficacy of an intramuscular     injection of BK1310 in healthy infants.   "
7425|NCT03188679|"     Cytomegalovirus (CMV) is the most common cause of congenital infection, with approximately     0.5% of pregnant women being infected during pregnancy. CMV transmission to the fetus occurs     in about one third of women who are infected in first trimester. Babies infected before birth     are at risk for serious neurological complications such as intellectual disability, seizures,     deafness, and even death. Most couples facing a diagnosis of congenital cytomegalovirus     infection in their unborn baby focus heavily on the predicted neurological outcome for their     child. To date, methods to assess brain development in fetuses have been mainly limited to     detecting structural brain abnormalities by ultrasound. However, these ultrasound signs may     not become apparent until very late in pregnancy, and some neurological disability is not     accompanied by any structural brain changes. More research on methods of predicting     neurodevelopmental outcome independent of structural brain malformations before third     trimester is urgently needed.      The purpose of this study is to investigate a new method of studying the health of unborn     babies using amniotic fluid. Amniocentesis is often performed after maternal CMV infection to     diagnose fetal infection. Prior research by Dr Hui has demonstrated that cell free RNA in     amniotic fluid can provide meaningful information from multiple organs including the fetal     brain. The investigators propose to collect and analyse a small sample of amniotic fluid to     detect which genes are turned on or off (gene expression) in a fetus that has a     congenital CMV infection, compared to those without any infection.      The genes that are differentially expressed in CMV infected fetuses will then be analysed to     provide information on the broad physiological processes that are altered due to the     infection (functional analysis) and identify neurodevelopmental gene transcripts of     interest for future studies (biomarker discovery).   "
7426|NCT03188666|"     This is a two period study design consisting of a 6-month, randomized, double-blind     placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period     2).      Primary safety objective of the study is to assess the safety and tolerability of REGN2477 in     male and female patients with fibrodysplasia ossificans progressiva (FOP).      Primary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on     the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined     by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of     HO lesions by computed tomography (CT).      Secondary objectives are:        -  To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as          determined by the number of new HO lesions identified by 18F-NaF PET or by CT        -  To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF          standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET        -  To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the          area under the curve (AUC) for pain based on daily numeric rating scale (NRS) scores        -  To assess the effect of REGN2477 versus placebo on the change from baseline in          biochemical markers of bone formation        -  To characterize the concentrations of total activin A at baseline and over time          following the first dose of study drug        -  To characterize the concentration-time profile (pharmacokinetics [PK]) of REGN2477 in          patients with FOP        -  To assess the immunogenicity of REGN2477   "
7427|NCT03188653|"     This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up     to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be     enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their     upper extremities. One spot will serve as a control and not receive any cleanser. Each spot     will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap     water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes     after rinse off.   "
7428|NCT03188640|"     The purpose of this study is to characterize the hormonal status in fertile women undergoing     laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation     between health-related quality of life and proposed hormone changes post-operatively.   "
7465|NCT03188159|"     This is a phase II study in patients with recurrent platinum resistant or refractory C5     high-grade serous, endometrioid or undifferentiated ovarian, primary peritoneal or fallopian     tube cancer. All patients with high-grade serous, endometrioid or undifferentiated primary     peritoneum, fallopian tube or ovarian cancer will be eligible to be screened for this trial     and will be required to sign a pre-screening consent form.   "
7432|NCT03188588|"     Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure.     This treatment is based on the principle of oxygen supplementation via a source to correct     hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate     (reporting by patients), but the results of the literature show poor LTOT compliance. It is     therefore important to accurately measure the oxygen consumption by patients and to     understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient     management to make them more observant in order to improve the therapeutic efficacy of the     treatment.   "
7433|NCT03188575|"     Depression and anxiety are common mental health problems. There are effective treatments for     depression and anxiety and one of these is talking therapies using cognitive behaviour     therapy (CBT). In recent years CBT has been transferred to online delivery methods and these     interventions have proven successful for people being treated with symptoms of depression and     anxiety.      The current study will utilise a randomised controlled trial design, where the majority     (n=240) of participants will be allocated to the immediate treatment (internet-delivered CBT     for either depression or anxiety), and a smaller number (n=120) will be allocated to a     waiting list. The waiting list group will receive treatment after an eight week wait. This     design helps us to understand that any changes in symptoms in the treatment group will be     likely due to the treatment they received compared to the waiting list.      A sample size of 360 participants is proposed and has been adjusted to ameliorate against     patient dropout. Follow-up and maintenance of any positive changes in symptoms is very     important in CBT for depression and anxiety, simply because some people can have a relapse of     symptoms. We will therefore follow-up the treatment group for 3, 6, 9 and 12 months to assess     maintenance of positive gains from treatment.      The study also seeks to investigate the cost effectiveness of the treatments.   "
7434|NCT03188562|"     The aim of the study is prospective comparison of diagnostical and therapeutical efficiency     between different methods of mediastinal lymph node preoperative staging in Non-Small-Cell     Lung Cancer (NSCLC).      Two hundred patients with histologically/cytologically confirmed clinical stage primary     I-IIIA NSCLC will be included. The patients must be fit enough to undergo at least pulmonary     lobectomy. Computer Tomography (CT) and Positron Emission Tomography (PET/CT) will be     performed in all patients. Subsequently, the patients without evidence of dissemination will     be randomized to transbronchial and transesophageal endoscopic ultrasound-guided needle     aspiration ( EBUS-TBNA, EUS-NA) or Transcervical Extended Mediastinal Lymphadenectomy     (TEMLA). The patients with N3 will be referred to definitive oncological treatment, the     patients with N2 metastases will be referred to neoadjuvant treatment and the patients     without N2/3 metastases will be operated on. The operative procedure will include at least     lobectomy with complete lymphadenectomy, with open or video-assisted (VATS) technique. The     patients undergoing sublobar resection will be excluded from this study. Final analysis will     include comparison of the diagnostic yield and 5-year survival between the EBUS/EUS and the     TEMLA arms.   "
7435|NCT03188549|"     Background: Procedures of hand hygiene are an important component in prevention of     cross-transmission of infections in hospitals. In recent years, hand washing with antiseptic     soap (chlorhexidine) was replaced with use of alcohol-based hand rub. This change brought an     increase in compliance with hand hygiene regulations from 30-40% to over 50%, and in other     places up to 70%. However, even 70% compliance is not enough. One of the reported reasons for     lack of compliance of staff to the use of alcohol-based preparations is skin irritation and     dryness of the hands as a result of frequent use. At Sheba, like the majority of Israeli     hospitals, the product used for handwashing is Septol (Teva), which includes 0.5%     chlorhexidine gluconate (CHG) and 70% ethyl alcohol. The CDC, WHO and FDA guidelines approve     for use of hospital hand hygiene, products that contain between 61-85% ethanol.      The investigators will replace the Septol currently used with a different alcohol-based     antiseptic that is more user-friendly, and aim to determine whether this will increase the     compliance with hand hygiene protocols.      The investigators will assess        1. Satisfaction of staff.        2. Increase of hand hygiene compliance.   "
7436|NCT03188536|"     The purpose of this study is to characterize the multiple myeloma (MM) participants with     symptomatic relapse and/or refractory disease in Spain.   "
7437|NCT03188523|"     This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and     anti-retroviral therapy (ART) activity of MK-8504 monotherapy, a tenofovir (TFV) pro-drug, in     ART-naïve, HIV-1 infected participants. The primary hypothesis is that MK-8504 has superior     antiretroviral activity compared to placebo, as measured by change from baseline in plasma     HIV-1 ribonucleic acid (RNA) at 168 hours postdose.   "
7438|NCT03188510|"     The purpose of this study is to look at the amount of the study drug, LY3074828, that gets     into the blood stream and how long it takes the body to get rid of LY3074828 when given as     different formulations. The tolerability of LY3074828 will also be evaluated and information     about any side effects experienced will be collected.      Screening is required within 28 days prior to the start of the study. For each participant,     the total duration of the clinical trial will be approximately 13 weeks, not including     screening.   "
7439|NCT03188497|"     Nasopharyngeal carcinoma (NPC) is a common malignant tumor in Southern China area, which is     characterized by obvious regional characteristics and Guangdong cancer. Radiotherapy is the     main treatment for locally advanced nasopharyngeal carcinoma. In recent years, chemotherapy     has improved the short-term and long-term survival of patients with locally advanced     nasopharyngeal carcinoma.      Lobaplatin is the third generation platinum anticancer drugs, mechanism of action and     traditional cisplatin is similar, mainly formed by the Pt-GG and Pt-AG chain cross connect,     replication and transcription process blocks of deoxyribonucleic acid(DNA), thereby     interfering with tumor cell cycle. The damage of DNA induced by lobaplatin can influence the     expression of tumor cell specific genes. Due to the different structure of lobaplatin and no     cross resistance to cisplatin in the study showed that, compared with cisplatin with     gastrointestinal reaction more mild, and no cisplatin common liver and kidney toxicity,     neurotoxicity and ototoxicity, in some tumors have a better adaptability; but compared with     cisplatin had more severe bone marrow suppression this, offset some of the advantages of     lobaplatin in a certain extent. At present, the clinical indications for the treatment of     such diseases include head and neck cancer, breast cancer, gastrointestinal cancer,     gynecologic malignant tumor and non small cell lung cancer. Tian Ying confirmed that     lobaplatin has obvious cytotoxic effect on nasopharyngeal carcinoma cells, in a concentration     dependent manner, the mechanism for the dual role, namely block at lower concentration of     cells in G2 phase and induce apoptosis at higher concentration, provide the possibility for     clinical treatment of nasopharyngeal carcinoma for lobaplatin; there are a number of clinical     study confirmed that lobaplatin chemoradiotherapy for locally advanced nasopharyngeal     carcinoma with cisplatin approximation. But at present, there is no report on the dose and     tolerability of concurrent radiotherapy for nasopharyngeal carcinoma.      Based on the above research background, this study used radical radiotherapy using lobaplatin     treatment III - IV stage B nasopharyngeal carcinoma, understanding of lobaplatin in locally     advanced nasopharyngeal carcinoma radiotherapy concurrent application dose tolerance and dose     limiting toxicity, and provide clinical basis for further research.   "
7440|NCT03188484|"     It is a randomized, observational and controlled non-blinded interventional cohort study,     divided into two different phases of generation and validation of the screening program. From     5,500 patients, 100 will be randomly selected for the first phase of the project to create     and apply a sequential screening program in a high-risk population by integrating clinical,     electrocardiographic and biological information, testing of different pulse devices     (MyDiagnostick, AliveCor and WatchBP) for AF screening, discovery of blood biomarkers for AF     by aptamer technology, and validation of biological candidates from the literature and     previous results. AF diagnosis will be based on detection in four-week Holter-EKG monitoring.     In the second phase, the investigators will apply the best candidates in a sequential     screening program in a high-risk population (aged 65-75 with hypertension and diabetes) by     clinical variables and performing pulse device detection. Biomarkers will be measured in the     negative cases to perform Holter-ECG monitoring in the highest-risk patients. In the final     step of the study, cost-efficacy analyses will be carried out.      The main objective is to develop a clinical model for AF prediction with the combination of     clinical information plus pulse device and blood markers in high-risk populations.   "
7441|NCT03188471|"     Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian     stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more     important than treatment.Preventive administration of GnRH antagonist for high risk OHSS     patients from the day of oocyte retrieval is not investigated. Besides, the relevant     mechanism is not clear yet. Here we designed a prospective randomized study to investigate     whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing     early ovarian hyperstimulation syndrome development than traditional aspirin preventive     administration in women at high risk for OHSS.   "
7442|NCT03188458|"     The purpose of the study is to support the recommendation of vaccination of all pregnant     women in Colombia with Diptheria, tetanus and pertussis (dTpa) by studying the transfer of     pertussis specific IgG antibodies from mother to the child.   "
7443|NCT03188445|"     Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron     deficiency anaemia in pregnancy   "
7444|NCT03188432|"     This randomized phase II trial studies hyperthermic intraperitoneal chemotherapy or     intraperitoneal chemotherapy in improving quality of life in patients with stage IIIC-IV     ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal     chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into     the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill     any cancer cells left over after surgery. Intraperitoneal chemotherapy is delivered directly     to the abdominal cavity to help treat cancer. It is not yet known whether hyperthermic     intraperitoneal chemotherapy or intraperitoneal chemotherapy works better in improving     quality of life in patients with ovarian, fallopian tube, or primary peritoneal cancer.   "
7447|NCT03188393|"     This phase II trial studies how well biopsy of breast after chemotherapy works in predicting     pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving     surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy     destroyed the breast cancer cells and may be compared to the tumor removed during surgery to     check if they are the same.   "
7466|NCT03188146|"     Several risk assessment scoring systems have been proposed to assess the therapeutic response     and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary     cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their     management. However there scoring systems have not been fully validated in Chinese     population. This study is going to compare the prognostic ability of these criteria, validate     the overseas scoring systems, develop and validate a new scoring system in a cohort of     Chinese PBC patients.   "
7618|NCT03186170|"     The investigators propose to assess one method of sperm selection based on the     characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a     gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better     quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional     technique of swin up) as well as embryo development.   "
7448|NCT03188380|"     Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns,     affecting up to 10% of very low birth weight infants (VLBW). In the most premature population     mortality rates can rise as high as 60%.      Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal     vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases.     Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head of     AR), but it also provides other crucial information such as bowel wall viability (thickness     or thinning) and free abdominal fluid. These additional findings are helpful in expediting     diagnosis and management of NEC.      Methods and analysis The hypothesis being tested is that preforming an AUR in patients with     clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and     expedite treatment in infants born at <32 weeks.      Discussion The use of AUS together with AR as an add-on test may increase the accuracy of     diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest     is extremely important. To our best knowledge, our study will be the first to focus only on     VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the     use of AUS as an add-on test, enabling us to recruit a significantly higher number of     patients compared to published studies.   "
7467|NCT03188133|"     Occurrence of visual hallucinations (VHs) in schizophrenia depend in part on disorders in the     processing of late visual information (Top-Down). The broader question of how these top-down     mechanisms (cognitive and / or emotional mechanisms) are involved in the occurrence of VHs     remains to be specified and very few behavioral studies have so far been interested. The     investigators propose to study the implication of Top-Down mechanisms in the visual     hallucinatory manifestations, more specifically in the processing of ambiguous stimuli during     an emotional priming task. Schizophrenia patients with VHs would have more false visual     perceptions in the treatment of ambiguous stimuli than schizophrenia patients with auditory     hallucinations or no hallucinations (AH/NH) and healthy controls.   "
7468|NCT03188120|"     The study objective is to investigate the safety and effectiveness of Spiriva Respimat in     patients with mild to moderate persistent asthma under real-world use   "
7449|NCT03188367|"     An emerging problem in clinical practice is how to manage the growing number of patients who     experience symptoms related to the ingestion of gluten-containing foods gluten and in whom     celiac disease has been ruled out. These patients most frequently report gastrointestinal     symptoms such as diarrhea, abdominal discomfort or pain, bloating, flatulence, but also     extraintestinal symptoms, including headache, lethargy, attention-deficit/hyperactivity     disorder, ataxia, or recurrent oral ulceration. This heterogeneous syndrome, which has been     reported to improve or even disappear after gluten withdrawal and to relapse after gluten     challenge, is called non-celiac gluten sensitivity.1 The concept of nonceliac gluten     sensitivity is not completely new. Besides several sporadic single cases reported, more than     30 years ago an oral, double-blind, placebo-controlled, cross-over gluten challenge trial     showed that six out of eight adult non-celiac patients, who suffered from intestinal symptoms     caused by the ingestion of gluten-containing food, were affected by gluten-sensitive     diarrhea. Over the last few years, an intense debate about the existence and the prevalence     of nonceliac gluten sensitivity has emerged, as shown by the considerable increase in     internet forums of discussion on this topic and in availability of gluten-free food. A     definition of nonceliac gluten sensitivity based on definitive scientific evidence does not     still exist, and the clinical trials conducted so far in order to fill this knowledge gap are     burdened by a number of biases. In a cross-over trial of subjects with suspected NCGS, the     severity of overall (intestinal plus extraintestinal) symptoms increased significantly during     1 week of intake of small amounts of gluten (daily 4.375 grams), compared with placebo. Among     the 59 participants in this trial, the Investigatotors identified only three true     gluten-sensitive patients, defined as having a delta overall score -calculated by subtracting     the weekly overall score under placebo from that under gluten- higher than the mean delta     overall score plus 2 standard deviations. However, these results should be cautiously     interpreted due to the lack of a control group of non-gluten-sensitive subjects.      On this basis, the Investigators will conduct a randomized, dose-finding, double-blind,     placebo-controlled, cross-over gluten challenge trial aimed at comparing the effects of a     daily dose of 8.4 grams of gluten with those of a daily dose of 6.0 or 4.2 grams of gluten on     a cohort of subjects with nonceliac gluten sensitivity versus healthy volunteers.   "
7450|NCT03188354|"     Primary central nervous system lymphoma (PCNSL) is a rare subtype of extranodal non-Hodgkins     Lymphoma (NHL) with rising incidence and variable response to treatment. MRI is considered     the most useful imaging modality of PCNSL, but conventional MRI has its limitations, and     contrast-enhanced MRI sometimes does not clearly differentiate PCNSL from other neoplasm or     non-neoplastic diseases.      Positron emission tomography (PET) could have a number of potential advantages in refining     and improving the management of patients with PCNSL. Because of the rare incidence of PCNSL,     the value of PET has however not been well defined in this subtype of lymphomas. There are a     few studies that have investigated the role for FDG-PET and amino acid PET in the primary     staging/diagnosis and response assessment in PCNSL patients, but the results are     inconclusive. Further studies are therefore needed.      Previous studies support an integration of both MRI and PET for the routine diagnostic workup     and response assessment for PCNSL, and the newly available simultaneous PET/MRI scanners may     have the potential to improve imaging baseline accuracy, response assessment and add     prognostic value in PCNSL.      The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI     examination with the clinical routine MRI examination given to these patients today. It will     be investigated whether PET (18F-FDG and 18F-fluciclovine) can provide additional prognostic     value at baseline and in response assessment compared to MRI and established pre-treatment     prognostic scores in PCNSL, and evaluate which PET/MRI parameters that are best suited as an     imaging biomarker for progression-free survival.   "
7451|NCT03188341|"     The vascular surgery is a highest risk procedure when considering postoperative complications     associated with the cardiovascular system. The leading clinical presentation is acute     hemodynamic decompensation. However, one of the possible pathomechanisms might be     repolarization disturbances. Many of perioperative risk factors of cardiac complications are     modifiable. The identification may help in the global perioperative risk reduction.      Aim: The aim of the study was an identification of the factors which may release clinically     overt repolarization disturbances.      Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic     aneurysms or peripheral arterial disease scheduled for an elective open vascular surgery     procedure. The authors investigated whether age, gender, comorbidities or some perioperative     factors (including hemodynamic, metabolic or genetic) were related to the occurrence of     clinically concealed repolarization disturbances or clinically disclosed cardiac     complications in postoperative time up to 30 day and one year after vascular surgery     procedure.   "
7452|NCT03188328|"     Local treatment of unresectable tumors is challenging, particularly with radioactivity.     Current practice relies on external beam irradiation or on a variety of medical devices for     brachytherapy. Both approaches proved useful in controlling tumor growth but are     characterized by poor patient's compliance, significant side effects, high costs and     technological complexity hampering wide-spread use. The use of AvidinOX for radionuclide     therapy of inoperable cancer lesions will offer a number of advantages compared to current     brachytherapy. In fact, the perfusion of a target tissue with AvidinOX, compared to current     devices, will allow adapting the therapy to the tumor/organ shape, and it will also make it     possible to delay the administration of radioactivity for several days which, according to     pre-clinical studies, might be also divided up into repeated doses. AvidinOX linking stably     to tissue proteins, does not exhibit the problem of seed migration which is associated with     high morbidity. Based on previous findings with AvidinOX in combination with radionuclides in     pre-clinical studies as well as data from the clinical use in liver metastases, it can be     assumed that intralesional injections of AvidinOX followed by intravenous injections of     177Lu-ST2210 could be a safe and efficacious method for treating inoperable tumor lesions.   "
7469|NCT03188107|"     The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor     Profile, and analyze interrater and intrarater reliability of this test.   "
7470|NCT03188094|"     The proposed study will inform efforts to prevent diabetes and promote weight loss in a     high-risk population and generate a reproducible, scalable, and sustainable model for use     with other insurer groups and clinical settings that work in immigrant populations with a     high burden of chronic disease.   "
7471|NCT03188081|"     The primary objective of this study is to investigate whether an Educational Supported     Program (ESP), including tight control procedures implemented through patient home care, has     positive impact in terms of better adherence to the therapy with abatacept SC at 12 months     after treatment start (1st injection). In the scope of this objective the adherence is     measured by the Medication Adherence Questionnaire (MAQ).   "
8139|NCT03179345|"     Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study     comparing simulated driving performance, daytime sedation and cognition in healthy volunteers     administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica®     (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.   "
7453|NCT03188315|"     Cancer is a devastating disease, presenting an immense disease burden to affected individuals     and their families as well as health care systems with 10.9 million new cases and 6.7 million     deaths per year. Approximately 12% of human cancers worldwide are caused by oncoviruses     infection with more than 80% of cases occurring in the developing world.      Tumor viruses can be classified into two groups based on their genetic material;        1. DNA tumor viruses:             1. Small DNA tumor viruses (Papilloma viruses, Polyoma viruses and adenoviruses).             2. Complex DNA tumor viruses (Herpes viruses and Hepatitis B viruses).        2. RNA tumor viruses ( Hepatitis C viruses and human T-cell leukemia virus HTLV).      There are around 100 types of HPV, with different variations in their genetic and oncogenic     potential [5]. Thus, HPV genotypes are divided into 2 groups based on their vulnerability;     High risk HPV (HR-HPV) and low risk HPV (LR-HPV).      The HPV genome encodes several oncoproteins [5]. E6 and E7 are the main genes responsible for     cell transformation mediated by HR-HPV, and they modulate the activities of cellular proteins     that regulate the cell cycle. Thus, the presence of E6/E7 can be a specific marker for     diagnosing precancerous lesions by HPV.      Knowledge of the etiology of virus-mediated carcinogenesis, the networking of pathways     involved in the transition from infection to cancer and the risk factors associated with each     type of cancer, all suggest prophylactic and therapeutic strategies that may reduce the risk     of virus-mediated cancer.   "
7454|NCT03188302|"     This study is designed to validate a new direct method for the measurement of stool     consistency, using Texture Analyser. Forty healthy subjects are enrolled in this trial for     collection of stool samples. Every stool produced during 2 collection periods of     approximately 60 hours each is collected and subjected to the measurement of consistency     using Texture Analyser. The stool consistency results are compared with the Bristol Stool     Form Scale scores for each stool. The relationships of stool consistency with other stool     parameters, bowel habit and sleeping habit are also evaluated.   "
7455|NCT03188289|"     This is a randomized clinical trial in which investigators will compare the antimicrobial     effect and inducer of cicatrization as well as the degree of postoperative pain in patients     who are extracted the lower third molars.      After the surgery, different bioadhesive gels will be applied in the area of the surgical     wound and we will evaluate the aforementioned parameters.   "
7456|NCT03188276|"     Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver     cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the     disease and the efficacy is seemingly not affected by a variety of viral factors. In     addition, direct-acting antiviral agents therapy may affect the transformation of the immune     cells and ameliorate the host immune status consequently. This study mainly investigated the     relationship between Direct Acting Antiviral Treatment effect and the functional activity of     myeloid-derived suppressor cells (MDSCs) and natural killer cells (NK cells) in Chronic     Hepatitis C.   "
7457|NCT03188263|"     The primary purpose of this pilot study is to test a novel head worn light device (Re-Timer®)     as an intervention to improve glucose metabolism in people with prediabetes. The hypothesis     is that morning light treatment will improve glucose metabolism. This is a pilot study and     the data from this project will be used to develop a larger clinical trial.   "
7458|NCT03188250|"     Preventing maternal and newborn deaths remain high on the global agenda. To address this, the     Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of     Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women     together in pregnancy and infancy. Central to the chama approach is the integration of     health, social and financial literacy education with a savings/loans program.   "
7459|NCT03188237|"     This proposal is a program evaluation of a group care delivery model designed for pregnant     women that was implemented as a pilot project in Teso District, Kenya in 2012.   "
7460|NCT03188224|"     Moving from child care to adult care is a hard time for patients and their families. Parents     of children with chronic conditions say they need more support around the time of changing     care. Care providers say they do not have the tools to provide smooth transitions or help     their patients manage their own health. This study is to see if a smart-phone-based app     (named MyTransition) can improve healthcare transition experiences and health outcomes for     youth, compared to usual care.   "
7461|NCT03188211|"     Atrial Fibrillation (AF) is the most common cardiac arrhythmia and the main cause of     cardioembolic stroke. Oral Anticoagulation (OAC) has been shown to significantly prevent     AF-related thromboembolism, however, despite convincing evidences and current guidelines     recommendations, OAC tends to be underused in clinical practice especially in the oldest.     Education and training to appropriately select people suitable for OAC for stroke prevention     could be pivotal in the decision making process. According to the study project, physicians     working in Internal Medicine and Geriatric wards, where are mainly admitted elderly people     with AF, will undergo to a program of e-learning through computer-based simulation method     reproducing clinical scenarios of patients aged 65 years or older, with known or newly     diagnosed AF, admitted to hospital for any medical reason and requesting that a decision     about long-term antithrombotic therapy is taken.      Primary objective of the study is to investigate whether such educational intervention will     improve the appropriate use and prescription rate of OAC in hospitalised elderly patients     with AF, multimorbidity and polypharmacy, in comparison to the usual practice.      The study will be a cluster randomised controlled trial involving a network of Internal     Medicine and Geriatrics wards. Thirty-two wards will be recruited based on voluntary     participation and randomised to receive an educational intervention through computer-based     simulation, (N=16) or to continue with the usual practice (N=16). Subjects receiving the     intervention will be all the staff physicians of the wards randomised in the intervention     arm.      The impact of the intervention compared with the usual practice will be evaluated in patients     aged 65 years or older admitted to the participating centres with a known diagnosis of AF or     newly diagnosed with AF during the hospitalisation.   "
7462|NCT03188198|"     This randomized phase II trial is studying two different combination chemotherapy regimens to     compare how well they work in treating patients with diffuse large B-cell lymphoma.   "
7463|NCT03188185|"     This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in     adults who have treatment refractory MDD.   "
7464|NCT03188172|"     To determine whether a combination of four novel agents bortezomib(Velcade), lenalidomide     (Revlimid), Daratumumab (Darzalex) & dexamethasone in combination with low-dose     cyclophosphamide is sufficiently active in a high risk population of myeloma patients, to     take forward into a phase III trial compared to standard treatment.   "
7720|NCT03184831|"     28 recruited patients indicated for sinus floor elevation with simultaneous implant placement     . they were divided into two groups. first group was assigned for placement of deproteinized     bovine bone solely, while the other group was assigned for the placement of mixture of     injectable platelet rich fibrin with deproteinized bovine bone into the sinus after implant     placement.   "
7472|NCT03188068|"     Kaposiform hemangioendothelioma (KHE) is a rare vascular neoplasm that occurs predominantly     in infancy or early childhood. KHE has a nearly equal sex ratio. The annual incidence of KHE     has been estimated at 0.071 per 100,000 children. KHE presents with intermediate-malignant     and locally aggressive characteristics but without distant metastases.      This pilot trial studies sirolimus versus sirolimus plus pednisolone in treating patients     diagnosed with kaposiform hemangioendothelioma (KHE) and Kasabach-Merritt phenomemon (KMP)     that cannot be removed by surgery. The purpose of this study is to compare the efficacy and     safety of orally administered sirolimus versus sirolimus plus pednisolone in the treatment of     KHE associated with KMP.   "
7473|NCT03188055|"     The purpose of this study is to test the effect of the Best Case/Worse Case (BC/WC)     communication tool on the quality of communication with older patients admitted to two trauma     units. The intervention was developed and tested with acute care surgical patients at the     University of Wisconsin (UW) and we are now testing whether the intervention will work in a     different setting. We will test the intervention with severely injured older adults at Oregon     Health Sciences University (OHSU) and Parkland Memorial Hospital (PMH) at the University of     Texas Southwestern (UTS). In the first year, UTS/PMH and OHSU will recruit and enroll 50     patients in the control arm (total, for both sites) and train trauma surgeons to use the best     case/worst case tool. In the second year, UTS/PMH and OHSU will recruit and enroll 50     patients in the intervention arm (total, for both sites). UW will compare survey-reported and     chart-derived measures before and after clinicians learn to use the best case/worst case     tool.   "
7474|NCT03188042|"     This pilot study will test the preliminary efficacy and feasibility of an intervention     protocol for one method of electric current stimulation, repetitive transorbital alternating     current stimulation (rtACS), to treat visual impairment in people with glaucoma. We will     evaluate a study protocol to use in future clinical trials to test the effectiveness of rtACS     to ameliorate the progressive effects of vision loss both structurally and functionally in     the eye, the visual pathway, and in regard to people's independence (i.e., functional     ability). In this prospective, randomized controlled, double-masked pilot study, we will: 1)     determine an effect of rtACS on ophthalmic structure and function (from retina to visual     brain), 2) assess the methodology of procedures for assessment of people's functional ability     and QoL to determine an effect of rtACS, and 3) assess the feasibility and implementation of     the pilot study protocol for a larger multi-site, randomized controlled trial.   "
7475|NCT03188029|"     The aim of this study is to investigate the effect of repeated doses of etomidate on the     adrenocortical synthesis of corticosteroids in patients aged 18 to 65, ASA status I to III     scheduled to electroconvulsive therapy every 2 days for 3 to 4 weeks.      Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5     mg/kg succinylcholine.      Blood samples for cortisol dosage are performed immediately before the first session     (baseline cortisol), 24 hours after the first session, 24 hours after the third session and     24 hours after the sixth session. All blood samples are performed at 9 and collected in     normal tube.      sample were analysed using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal     value are between 6.2-19.4 µg/dL . Sample analysis was performed by a biochemist blinded to     clinical detail.   "
7476|NCT03188016|"     The project will investigate the effectiveness of a specialised musical-clinical approach     used as an adjunct to an established non-musical intervention in the enhancement of     interpersonal interaction.      6 school pupils with profound disability will be randomly allocated to experimental and     control groups. The control group will receive only Intensive Interaction for 16 sessions.     The experimental group will receive four sessions of Intensive Interaction, followed by     twelve sessions of Intensive Interaction plus improvised music. Music therapists will follow     a flexible manual written to ensure that their music supports the interaction between pupil     and learning support assistant (LSA) without direct social interaction with either.      Changes in capacity for interpersonal interaction will be assessed by a standardised     assessment instrument, the Pre-Verbal Communication Schedule (PVCS), administered to both     experimental and control groups before the 1st session and after the 16th session.      There will also be a qualitative process study of the experimental group conducted by video     observation by the researchers involved.      The project is funded in equal shares by the Music Therapy Charity and Beacon Hill Academy.   "
7750|NCT03184441|"     This pilot project proposes to develop and test a new device to manage (defined as resolving,     prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in     prematurely born infants weighing < 1 kilogram.   "
37677|NCT02792478|"     Analysis of freely circulating DNA in liquid biopsies using the BEAMing method   "
7477|NCT03188003|"     Lumbar pain is one of the most common injuries being the cause of morbidity in the individual     generating occupational disability with strong personal, social and economic impact. As one     of the methods of treatment, Pilates is a method that has good results for the management of     this dysfunction. However, it is not known exactly which approach Pilates can bring better     results for this population. Therefore, the purpose of this study is to compare the effects     of two types of Pilates method interventions on non-specific chronic low back pain.      A blinded randomized clinical trial, will be held. 32 patients divided randomly into two     groups will be assessed, the Mobilization Pilates (MP) and the Stabilization Pilates (SP).     Both groups will be formed by individuals of both sexes and aged 21 to 41 years with chronic     low back pain. Both groups will receive 10 sessions of Pilates Methods twice a week, with     each session taking an average of 50 minutes, therefore the MP will focus on a lumbo-pelvic     mobilization exercises approach and the SP will focus on lumbo-pelvic stabilization exercises     approach. At the beginning and end of the 5 weeks the individuals are evaluated to verify the     presence of pain and disability with VAS of pain and Oswestry Questionnaire, and also with     the Functional Movement Screen. Data will be analyzed statistically.   "
7478|NCT03187990|"     In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not     detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or     tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the     ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately     direct prostate needle biopsy using the Gleason score from the histology of the core biopsies     as standard of truth.   "
7479|NCT03187977|"     Computer-based cognitive training has been found to be helpful for improving attention and     working memory in pediatric and adult patients with existing cognitive difficulties. A     previous study was conducted at St. Jude Children's Research Hospital with survivors of     childhood cancer who were experiencing difficulties with attention and/or working memory.     Findings from that study indicated that the use of Cogmed, computer-based cognitive training,     is effective in improving attention and working memory in survivors.      Researchers want to learn whether Cogmed intervention completed at the end of therapy for     acute lymphoblastic leukemia will be effective for all survivors (i.e., regardless of whether     they have existing difficulties).      PRIMARY OBJECTIVES:        -  To evaluate the overall participation rate in a randomized, standard-of-care controlled          trial of computerized cognitive intervention administered at the end of TOTXVI therapy.        -  To estimate the study completion rate in a randomized, standard-of-care controlled trial          of computerized cognitive intervention administered at the end of TOTXVI therapy.        -  To estimate the compliance rate for participants randomized to the intervention arm of a          computerized cognitive intervention administered at the end of TOTXVI therapy.        -  To estimate the standard deviation for the overall cohort on a measure of working          memory.        -  To use neuroimaging data collected in the context of the Total Therapy XVI trial to          explore candidate biomarkers predictive of response to the computerized cognitive          intervention.   "
7480|NCT03187964|"     TB is increasingly diagnosed using the GeneXpert platform, which can be used for a variety of     tests (not just TB). HIV viral load monitoring is required at least annually in patients on     ART to detect failure of virologic suppression, however, most HIV VL testing is done in a     central lab. If a patient has virologic failure, these patients are more likely to get TB.      The investigators wish to see if Xpert done at the clinic results in faster patient TB     diagnosis and treatment initiation compared to sending specimens away to a central     laboratory. In a different patient group (PLHIV returning for HIV treatment monitoring), the     investigators wish to see if POC Xpert HIV-1 viral load (Xpert VL) monitoring results in     faster patient viral load quantification compared to sending patient specimens to a     centralised laboratory. Both POC tests will use the same testing hardware. This polyvalent     utility of the GeneXpert system is hitherto uninvestigated in this local setting.      Newly diagnosed pre-ART HIV positive patients will be approached and asked to be a part of     this study. Patients will be randomly assigned to Ultra done at the clinic or the normal     off-site laboratory TB testing. The time taken for patients to get diagnosed and how long it     takes to start treatment will be recorded. Additionally, a different group of HIV positive     patients (on ART) returning to the clinic for annual follow-up visits will also be asked to     join the study. These patients will be randomly selected for either Xpert VL testing done at     the clinic or the normal off-site laboratory VL testing. The time taken for patients to     receive viral load results will be recorded. The time taken for patients to have ART regimen     adjusted, receive adherence counselling or received HIV drug susceptibility testing will be     recorded should the patient's viral loads be found to be higher than anticipated and     considered by the clinical to indicate a lack of viral suppression.      This project will confirm if Ultra TB testing performs well in PLHIV irrespective of     symptoms, and may produce evidence that supports universal TB testing in this important and     vulnerable patient group. The investigators will also assess whether POC placement of Ultra     and Xpert VL has benefits (e.g., more patients diagnosed for TB or VL monitored during the     same day visit).   "
7481|NCT03187951|"     The goal of this clinical research study is to learn if regular exercise and behavioral     skills training can help to improve physical activity in patients with pancreatic cancer who     are scheduled to receive chemotherapy and/or radiation before standard-of-care surgery.   "
7482|NCT03187938|"     Alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its     levels are normally increased in pregnancy. Therefore, it would be reasonable to hypothesize     that alkaline phosphatase would be low to low normal in cases of low birth weight /     intrauterine growth restriction (IUGR)/ placental insufficiency.   "
7483|NCT03187925|"     Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is     used to divide the common wall between the diverticulum and esophagus, or who are not     surgical candidates but agree to follow-up.   "
7484|NCT03187912|"     Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation     intensities and shorter irradiation times have been introduced. In addition, new riboflavin     solutions with HPMC (hydroxylpropyl methylcellulose) instead of dextran found its way into     CXL-treatment. The aim of this trial is to evaluate clinical outcomes in an accelerated     corneal collagen cross-linking protocol with different riboflavin solutions.   "
7485|NCT03187899|"     The goal of the study is to determine if the addition of a superficial cervical plexus block     to a traditional interscalene plexus block will provide superior perioperative analgesia to     an interscalene brachial plexus blockade alone for repair of clavicle fractures and     non-/malunions.   "
7500|NCT03187704|"     The study is a blinded cross over test of in-home air filtration. Participants will have a     window unit air filter (HEPA) installed that will filter for 3 weeks and do sham filtration     for another 3 weeks. During the time that the filter is installed in the home a machine that     measures particulate air pollution of the type that the filter is designed to remove will be     installed. A survey will be administered, blood samples taken and blood pressure measured     immediately prior to starting the filter, at 3 weeks when the filtration is changed from sham     to real filtration or visa versa and at the end of the second three week period. All     participants will be recruited from the Boston Puerto Rican Health Study cohort.   "
7486|NCT03187886|"     INTRODUCTION: Cerebral amyloid angiopathy-related inflammation (CAA-ri) is a very rare     manifestation of cerebral amyloid angiopathy, characterized by acute/subacute neurological     deterioration and T2/FLAIR corticosubcortical or deep white matter hyperintensity. With the     advent of new diagnostic criteria, there are more and more case reports and series reported;     nevertheless, MRI findings and follow-up data need to be thoroughly described.      OBJECTIVES: Our aim in this multicentrical and retrospective study was to describe the     clinical and radiological features of patients with CAA-ri and assess long-term prognosis.      METHODS: We reviewed the characteristics of 28 patients with CAA-ri including clinical data,     systematic MRI analysis, cerebrospinal fluid results (including Alzheimer's disease     biomarkers) and APOE genotype.      HYPOTHESIS: We aimed at describing the clinical and radiological characteristics of a cohort     of patients with CAA-ri.   "
7487|NCT03187873|"     This team has shown that chamas can be tailored to increase the uptake of health services in     pregnancy and infancy, sustain themselves beyond the period of funding and become integrated     within a county's health strategy. However, further investment is warranted to validate this     intervention in a new region to ensure the positive effects on MNCH are a result of chamas     and can be replicated. The purpose of this study is to demonstrate that chamas are an     effective service-delivery platform for improving women's and children's health and     well-being in western Kenya.   "
9989|NCT03155191|"     Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of     autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR)     (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.   "
7488|NCT03187860|"     This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without     chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.      Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface     cell cultures. These will then be used to make observations concerning cilia and mucus     rheology.      This is a first pilot study. The working hypothesis is that the largest group differences     will be found for cilia densities; the latter metric was thus chosen as a primary criterion.   "
7489|NCT03187847|"     The primary objective is to evaluate changes in fatigue and physical activity (steps per day)     before and after rehabilitation in patients with MS (EDSS 3-6.5).      The association of changes in fatigue and physical activity will also be analyzed for disease     severity, the HRV, quality of life and the emotional status of the participants.   "
7490|NCT03187834|"     The use of antibiotics has saved millions of human lives, however consumption of antibiotics     can select for antibiotic resistant organisms and may lead to changes in commensal     microbiome. This study is designed to estimate the effect of antibiotic consumption on     microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and     nasopharyngeal microbiome and resistome following a short course of antibiotics will be     measured.   "
7491|NCT03187821|"     The purpose of this study is to determine if location of laser peripheral iridotomy (LPI)     that is the standard of care treatment for angle closure glaucoma is related to changes in     post-operative intraocular pressure (IOP), endothelial cell count,anterior chamber angle     morphology and onset of new visual disturbances.   "
7492|NCT03187808|"     This study aims to compare the immediate effects of using a single thoracic manipulation     combined with special massage technique (RT technique) and single thoracic manipulation alone     on pain level at rest, cervical range of motion, upper limb neurodynamic test, neck     disability, and adverse effects in chronic mechanical neck pain patients.   "
7493|NCT03187795|"     The purpose of this research study is to determine the effectiveness and safety of mirabegron     compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called     neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI).   "
7494|NCT03187782|"     The mechanism led to the dysmenorrhea can be understood more clearly and one may have a     better idea to treat the disease in the future.   "
7495|NCT03187769|"     This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in     young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in     their illness   "
7496|NCT03187756|"     This is an open label phase II single arm study of peripheral blood stem cell transplantation     and posttransplantation cyclophosphamide, using HLA full match or haploidentical related     donors, in hematological malignancies including those difficult to engraft. The objective of     this study is to evaluate the safety and feasibility in nonmyeloablative, partially     HLA-mismatched or HLA-matched PBSC transplant from haploidentical donors or fully matched     donors with post-grafting immunosuppression that includes high-dose cyclophosphamide,     tacrolimus, and Mycophenolate mofetil (MMF).   "
7497|NCT03187743|"     This research study is a multicentre prospective pharmacokinetic study. The clinical and     biological data will be collected in the framework of a prospective study. The drug to be     evaluated is a glucocorticoid routinely used to treat Systemic lupus erythematosus (SLE)     patient. Initial dose of prednisone must be oral and at least 0.5mg/Kg/day, but the precise     dosage and the tapering regimen will be determined according to the clinical judgment of the     investigator. The duration of the research period for each patient will be 3 months. Three     visits (which are all usual care visits) will be needed within the 3 months of the study for     collecting data and/or blood sampling   "
7498|NCT03187730|"     This is a 24 month pilot project that will implement and evaluate an innovative program that     integrates financial counseling with smoking cessation counseling for low-income immigrants.   "
7499|NCT03187717|"     The aim of us is to define the incidence of postoperative complications and recovery time in     view of two anesthesia procedures.      During the period between 01.01.2016 and 01.01.2017, totally 583 patients were included in     the study, who had oral and maxillofacial surgeries. Anesthesia types were determined as     total intravenous anesthesia (TIVA) and inhalation anesthesia (IA). Postoperative     complications and recovery period were determined as tachycardia, bradycardia, hypertension,     hypotension, recovery time, additional analgesia, nausea-vomiting. Both anesthesia procedures     were compared in terms of these postoperative complications and recovery time.   "
7501|NCT03187691|"     A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute     myelogenous (AML) or lymphoblastic leukaemia (ALL)   "
7751|NCT03184428|"     This study collects intra- and postoperative data from the patients´charts retrospectively     and evaluates retro- and prospectively the rate of posterior capsule opacification (PCO)     following implantation of the intraocular lens L 313.   "
7502|NCT03187678|"     The development of selexipag for intravenous administration will be useful to avoid treatment     interruptions in patients with pulmonary arterial hypertension (PAH) already treated with     selexipag administered orally as tablets (Uptravi®). The target population for intravenous     selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets     of Uptravi.      The primary objective of this study is to assess whether it is safe for patients with PAH to     temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein     (intravenous selexipag), and then switching back to the initial oral dose of selexipag.   "
7529|NCT03187327|"     In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or     salpingo-oophorectomy were included. The objective of this study is to assess the feasibility     of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the     prevalence of occult tubal lesions. The hypothesis is that prophylactic salpingectomy during     vaginal hysterectomy for benign pathology present a low failure rate and it makes it possible     to avoid the appearance of a certain number of ovarian cancers. The prevalence of bilateral     salpingectomy with or without ovariectomy and the prevalence of histopathological and     immunohistochemical (p53 expression) abnormalities were evaluated.   "
7530|NCT03187314|"     The objective of this study is to evaluate the efficacy and safety of radiation therapy     combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer   "
7503|NCT03187665|"     This research study will help the investigators to learn more about a device used when     children are sick called a pulse oximeter. The pulse oximeter measures how much oxygen is     inside a child's blood without taking blood from the child. It is non-invasive meaning it     does not enter the body. The device has a cable attached to it. At the end of the cable is a     wrap that looks like a Band-Aid with a red light on it. This wrap is placed around a finger     or toe. The red light gives the investigators a reading of how much oxygen is in the child's     blood and the child's heart rate. Having a pulse oximeter connected to a child is painless.     This device is used in many places. Besides hospitals, it is used in doctors' offices and in     fitness centers.      This study will help the investigators learn more about whether a partially wireless, more     portable pulse oximeter that connects to a small device worn on the child's arm or leg will     give the investigators a more reliable signal/reading while letting children move more     easily. The investigators will compare this device with the traditional wall-connected unit.     Movement of the cable or a child moving may give a false oxygen reading. The investigators     will ask the child to do activities that create movement and will look at the readings when     the child moves. The investigators think the partially wireless pulse oximeter will be more     reliable during movement than the traditional wall-connected unit.      Subjects will have two continuous pulse oximeter probes placed on them. These soft probes     will go on a finger, toe, foot or hand and will be attached to two different pulse oximeter     monitors. The child will then be asked to do common childhood activities based on their age     for about 20 minutes. These activities will be play activities the child already does such as     grabbing a toy, drawing with crayons or kicking a ball. Continuous pulse oximetry data will     be recorded during the testing and will be stored in a way that it cannot be linked to the     subject after the testing is complete.   "
7504|NCT03187652|"     A prospective cohort study of idiopathic TTP patients who have presented with their first     episode and are in remission within the last 30 days. They will be followed for 12 months     from the time of their remission, followed by a long-term follow up study.   "
7505|NCT03187639|"     To determine whether, in a population of patients presenting to the rapid access chest pain     clinic (RACPC), routine FFRct (Fractional Flow Reserve Computed Tomography) as a default test     is superior in terms of resource utilisation when compared to routine clinical pathway     algorithms recommended by the National Institute for Health and Care Excellence (NICE)   "
7506|NCT03187626|"     The primary purpose of this study is to determine whether a single ultrasound-guided     intra-articular injection of botulinum toxin A associated to splinting is effective in     reducing pain at 3 months in base-of-thumb osteoarthritis.   "
7507|NCT03187613|"     Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated     for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal     shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.   "
7508|NCT03187600|"     The investigators want to compare two different surgical techniques for the treatment of a     condition called velopharyngeal dysfunction (VPD). VPD is a condition in which the nasal part     of the airway does not close properly during speaking and feeding. The current standard     surgical management involves taking a pharyngeal flap from the back of the throat comprised     of muscle and overlying mucosal tissue to create a functioning valve. The proposed technique     would use only the mucosal/submucosal layer of the pharynx for the flap. This technique has     been shown to be effective in animal models and it is hoped that it will lead to faster     healing, lower complications and improved functional outcome for patients.   "
7509|NCT03187587|"     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a     tumor specific immunologic response. In laboratory animals the imILT method has also been     shown to induce a so called abscopal effect. This means that when one tumor is treated with     imILT other, untreated, tumors also decrease in size.      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction     of the imILT treatment method performed pecutaneously in patients diagnosed with pancreatic     cancer. The purpose is also to investigate the functionality and safety of the method.      This trial is an open-label, double-arm study. Twenty patients diagnosed with pancreatic     cancer will be treated in this trial, ten recieving imILT treatment and ten recieving     standard chemotherapy. The study is estimated to be carried out during a time period of 21     months.   "
7510|NCT03187574|"     Our study is a non-randomized prospective study compared two groups matched for     anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42     Perigee™ transvaginal mesh (group B). The study hypothesis was that the Elevate Ant™ mesh     would provide better apical correction than the Perigee™ mesh. One- and 2-year follow-up     comprised anatomic assessment (POP-Q) and QoL (PFDI-20, PFIQ-7, PISQ-12). Success was defined     as 2-year POP-Q ≤1. Secondary endpoints were function and complications.   "
7511|NCT03187561|"     This 3-arm RCT tests the effects of a sleep-enhanced adaptation (FF+) of a well-known,     evidence-based transition-to-parenting coparenting intervention program (Family Foundations;     FF). In one arm, families will experience FF as originally formulated; in the second,     families will receive an adapted FF (FF+) program that emphasizes coparenting in infant sleep     contexts; the third arm will serve as controls. It is hypothesized that (1) Compared to     controls, parents in both FF groups will report improved overall coparenting and reduced     overall distress, but parents in the FF+ group will show greater improvements in coparenting     and individual parenting in infant sleep contexts, better infant and parent sleep, and better     child adjustment; (2) early coparenting around infant sleep will be a central mechanism by     which both interventions exert their effects.   "
7512|NCT03187548|"     This study is aiming in preventing the formation of WSL associated with orthodontic treatment     which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on     the enamel surface once every 2 weeks for 3 months.   "
7513|NCT03187535|"     The proposed research will utilize electroacupuncture, a type of needleless acupuncture that     uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of     post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the     transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.   "
7752|NCT03184415|"     THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156     Combination Therapy in Patients with Gastritis   "
7531|NCT03187301|"     A cardiac safety study of an investigational drug to see how it affects the heart in people     with Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)   "
7532|NCT03187288|"     This is a phase 1 study of investigational drug CFI-400945 in patients with relapsed or     refractory acute myeloid leukemia or myelodysplastic syndrome. The purpose of this phase 1     study is to see how safe and tolerable the study drug is and to determine the best dose     (maximum tolerated dose or recommended phase 2 dose) that can be given in this patient     population.   "
7515|NCT03187509|"     This study will be a randomized open-label pilot study. The purpose of the study is to     compare standard of care outpatient heart failure management versus a weight based torsemide     regimen. Subjects admitted to the hospital for heart failure exacerbation will be randomized     upon discharge to either standard of care outpatient heart failure management or a weight     based torsemide regimen. Those subjects randomized to standard of care therapy will be     prescribed a daily fixed dose of a loop diuretic at hospital discharge and have a follow-up     appointment within one week of discharge. All management decisions including loop diuretic     type, dose and frequency will be made at the discretion of the subject's personal physician.     Those randomized to an individualized weight based torsemide regimen will be prescribed a     dose of torsemide upon hospital discharge based on a prespecified algorithm. These subjects     will then undergo physician-subject phone encounters three times a week where the subject's     torsemide dose will be modified based on the prespecified algorithm which incorporates     current symptoms and weight. Primary end-point will be an unbiased estimate of 30-day all     cause readmission rates. Secondary end-points include incidence of acute kidney injury,     changes in brain natriuretic peptide levels from baseline and a preliminary estimate of the     effect size and feasibility of a weight-based torsemide regimen intervention in order to plan     a future larger study.   "
7516|NCT03187496|"     A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of     concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam,     caffeine, and rosuvastatin in healthy human volunteers.   "
7517|NCT03187483|"     This study aimed to compare flash-free bracket system with conventional adhesive-coated     bracket system in patients with maxillary crowding.   "
7518|NCT03187470|"     Left ventricular dyssynchrony will be assessed by echocardiography using different     programming of an implantable cardioverter defibrillator.   "
7519|NCT03187457|"     The study will assess vaginal microbiota levels before and after antibiotic treatment in     females infected with Bacterial Vaginosis (BV).   "
7520|NCT03187444|"     Chronic inflammatory rheumatism and inflammation can increase the risk of cardiovascular     problems. Indeed, these diseases can increase the risk of myocardial infarction. The     objective of this project is a better understanding and preventing the risk of cardiovascular     problems in chronic inflammatory rheumatism through the study on the long-term flexibility of     the arteries, blood markers of cardiovascular risk and muscle mass.   "
7521|NCT03187431|"     Currently, the application status of MSCs as treatment modalities in IPF is still in its     infancy and remains exploratory. Although a number of safety and efficacy clinical trials of     MSCs as therapeutic options in immune-mediated and cardiac diseases have already been     published with tantalizing results, to our disappointment, pulmonary and critical care     medicine have traditionally lagged behind other therapeutic and research fields including     hematology, gastroenterology and cardiology in translational studies of the use of reparative     cells   "
7522|NCT03187418|"     The goal of this study is to evaluate the efficacy and safety of the novel form of     trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana     treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in     adults for the treatment of uncontrolled glaucoma.   "
7523|NCT03187405|"     Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with delayed     cerebral ischemia (DCI) as a major complication. There are several evidences, both in     preclinical and in clinical studies that intraventricular fibrinolysis (IVF) controls the     phenomenon that are leading to DCI. Here, the investigators propose to conduct a phase III     trial to provide a clear evaluation of the impact of IVF after aneurysmal SAH.   "
7524|NCT03187392|"     The aim of our study is to compare the analgesic effect of topical application of     lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control     implants   "
7525|NCT03187379|"     This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric     bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine     injection solution) injections intra-operatively at time of incision site closure. The     control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of     incision site closure. The medication for the control group is our current standard of care.     The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog     Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will     be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours     a member of the research team will administer a 2-part questionnaire containing the VAS and     the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is     validated for assessment of the patient's experience of pain and it hindrance to daily     activity in the post operative period.   "
7526|NCT03187366|"     Schistosomiasis is a flatworm transmitted from freshwater snails to humans in the tropics. In     addition to this infectious disease, tropical developing countries are faced with     malnutrition. We propose to alter pesticide and compost use to reduce schistosomiasis and     maintain or even improve crop production.   "
7528|NCT03187340|"     Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and     numerous negative health consequences including depression. Advanced Medical Electronics, in     partnership with researchers are the University of Pennsylvania, propose developing an     innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for     the treatment of insomnia   "
7619|NCT03186157|"     Decompressive craniectomy is frequently used to treat increased intracranial pressure or an     intracranial mass effect. Trephined Syndrome describes a neurological deterioration, which is     attributed to a large craniectomy. The symptomatology is varied but includes headache,     aggravation of a hemisyndrome or cognitive disorders, often has an orthostatic component and     improves or disappears with cranioplasty. The incidence of Trephined Syndrome has been     reported between 7% and 26%. However, it might be underestimated if the course of cognitive     functions before and after cranioplasty were insufficiently documented.   "
8151|NCT03179189|"     The pathophysiology and treatment of sepsis disease are still not fully known. International     guides often refer to the studies done in the developed countries and suggest some     treatments. The infrastructure of the developing countries is quite different. For this     reason, it is not exactly scientific how much these proposals are reflected in patient     treatment. In our study, We will try to reveal the treatment of sepsis.   "
7533|NCT03187275|"     Cancer-related fatigue (CRF) is a prevalent and debilitating symptom experienced by cancer     survivors. CRF can persist for months or years after cancer therapy is completed and has a     negative impact on all areas of mental and physical function. Treatment options for CRF are     extremely limited and finding safe, inexpensive, and effective interventions for managing     this distressing symptom are urgently needed. Massage therapy is one of the fastest growing     complementary therapies. A recently completed study in breast cancer survivors with CRF found     that Swedish Massage Therapy (SMT) caused a significant reduction in fatigue and improvement     in quality of life. This study investigates the effects of massage therapy on CRF among     prostate cancer survivors. The study will evaluate whether SMT improves quality of life,     depression, and anxiety. Second, this study will evaluate if SMT reduces CRF by decreasing     the pro-inflammatory cytokine Interleukin-6 (IL-6). Lastly, to establish measures of reduced     fatigue beyond self report at the treatment visits, the researchers will implement     continuous, real-time monitoring of physiologic and psychological signs and symptoms,     throughout the treatment period. This study will improve care for CRF and other     hard-to-manage symptoms of cancer treatment and provide preliminary evidence of immune     modulation as a potential mechanism of action.      This study is a randomized clinical trial to test the efficacy of Swedish massage therapy     (SMT) versus an active control condition (light touch, LT) on cancer related fatigue in men     with prostatic cancer, at least 2 months after the end of their radiation therapy and who are     on androgen depletion therapy. The primary outcome is the Multidimensional Fatigue Inventory     (MFI). Secondary outcomes are the Patient-Reported Outcomes Measurement System (PROMIS)     Fatigue Scale, plasma concentrations of cytokine IL-6, self-reported quality of life,     depression, and anxiety, wearable measures of activity and sleep, and Automated Monitoring of     Symptom Severity (AMoSS) ratings.   "
7534|NCT03187262|"     This research study is studying Daratumumab as a possible treatment for Waldenström     Macroglobulinemia.   "
7535|NCT03187249|"     Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary     disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary     rehabilitation are promising in improving life quality, disease symptom and outcomes. But     there's not standard algorithm in China so far. The study aims to compare the effectiveness     of these interventions and develop an intervention algorithm of anxiety and depression in     COPD.   "
7536|NCT03187236|"     Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease     (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and     depression tend to have more severe symptoms and worse prognosis, but the related evidences     are not strong enough. The study aim to investigate the prevalence and long-term outcome of     anxiety and depression in COPD.   "
7537|NCT03187223|"     Two high-dose chemotherapy regimens (melphalan alone versus the combination of melphalan and     bendamustine) used for conditioning treatment before autologous stem cell transplantation     will be compared in a 1:1 randomization in myeloma patients. The experimental arm is the     bendamustine and melphalan (BenMel) combined regimen. The melphalan alone (Mel) regimen is     the control (standard) treatment. Despite remarkable progress using novel agents both for     induction before ASCT as well for maintenance after ASCT, definite cure in myeloma patients     remains exceptional due to residual disease escaping intensive treatment. The aim of the     study is to show an improvement of the rate of complete Remission 60 days after ASCT in     myeloma patients from 50% with melphalan alone to 65% with the combination of bendamustine     and melphalan.   "
7538|NCT03187210|"     The trial assess the maximum tolerated dose of a single-dose of Brentuximab Vedotin added to     standard BeEAM chemotherapy (comprising Bendamustin, Etoposide, Cyclophosphamide and     Melphalan) before autologous stem cell transplantation in CD30+ malignant lymphomas.   "
7539|NCT03187197|"     To describe the treatment perception from patients with non-valvular atrial fibrillation     (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation     questionnaire of PACT-Q during a 6-month study period.   "
7540|NCT03187184|"     Pharmacogenomics (PGx) studies the interactions between an individuals genes and medications.     PGx testing identifies genes within an individual that may affect treatment, efficacy, and     toxicity of drugs. With improvements in testing speed, accuracy and cost, it is now possible     to perform PGx testing in cancer patients prior to starting chemotherapy. The test results     may help a physician personalize chemotherapy dosing. The goal of this study is to determine     if PGx testing using the OneOme® Rightmed test is feasible in a community oncology clinic to     guide treatment prior to starting chemotherapy. The study will also gather data regarding the     frequency of genes within the local population as well as the impact of testing on     chemotherapy doses.   "
7541|NCT03187171|"     This research protocol seeks to compare radiological and clinical outcomes of cervical spine     disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF)     using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device.      This clinical study presents little to no additional risk to study subjects beyond those     associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an     ACDF procedure will be enrolled in the study. The study consists of a completing a series of     questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate     of successful spinal fusion for each group. For evaluation of the primary endpoint and     additional assessments, descriptive statistics including mean, standard deviation, minimum,     median, and maximum for continuous variables and frequency distribution for categorical     variables will be provided, as well as tabular listings. All complications will be itemized     including incidence, duration, and relationship to the device used and/or procedures     performed.   "
7542|NCT03187158|"     Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant     of the rate of lung function decline during the later years of life. The attainment of a     healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment     and nutrition) and exposure to environmental toxicants and nutrition during childhood and     early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on     maternal nutrition and anthropometry can provide invaluable insight into the factors     affecting lung function growth and their effect sizes in the Indian population. Therefore, in     this observational study, the Investigator will be collecting data on lung function, current     nutritional and environmental exposures and linking it to pre and peri natal data of the same     participants in order to understand lung function growth and the reasons for an early decline     in the Indian population, using a life course approach.   "
7543|NCT03187145|"     This is a prospective cohort study. The main objective is to compare the frequency of a full     stomach in the diabetic population compared to healthy controls 2 h after clear liquid and     6h after a light meal, and evaluate the mean gastric emptying time of clear liquid and light     meal in diabetic patients.   "
9990|NCT03155178|"     The objective of the study is to demonstrate persistent effect of the CHG/IPA Prep on skin     flora of the abdomen and inguinal regions of human subjects.   "
7544|NCT03187132|"     This study will test the effectiveness of an evidence-based, multi-modal, digital     pain-reduction kit as a non-pharmacological supplement to managing patients with acute pain     due to orthopedic injuries. Outpatients will be randomized to receive either the pain     reduction kit or an active control. The kit will contain a virtual reality (VR) headset,     therapeutic VR visualization software, a low-cost wearable transcutaneous electrical nerve     stimulation (TENS) unit, and a remote activity monitor. Clinical staff will monitor progress     and provide scheduled coaching and outreach to patients in the intervention group. The     control group will receive a remote activity monitor alone; they will not receive VR, TENS,     or remote coaching. Study devices will be delivered to the patient's home with instructions     for use; patients will receive remote clinical and technical support. Patients will be     followed for 60 days and monitored for functional status, pain levels, use of pain     medications (including opioids), satisfaction with care, and time to returning to work.   "
7545|NCT03187119|"     The aim of this study is to investigate the potential benefit of Pictorial versus Written     Asthma Action Plans (AAPs) to support asthma management among young people with persistent     asthma. Participants will be randomly allocated to the Pictorial or Written AAP group and     followed up over a 6-month period. Qualitative and quantitative data will be collected from     young people, parents and clinical teams involved in recruitment to assess the feasibility     and acceptability of the Pictorial AAP (PAAP) software developed for this study, the PAAPs     produced by the software, and the study procedures.   "
7546|NCT03187106|"     The purpose of this study is to determine if the addition of a 48-hour course of     post-operative antibiotics to the recommended course of pre-operative antibiotics improves     surgical site infection rate in patients who are obese and undergo Cesarean section after     laboring.   "
7547|NCT03187093|"     Major Depressive Disorder (MDD) is one of the most prevalent mental diagnosis within the     worldwide population. Although there is evidence about relationship between MDD and cognitive     dysfunction, still the correlations between biomarkers and the severity of the disorder or     the level of cognitive dysfunction need further research. Therefore, the aim of the study is     to determine such relationships in Ukrainian population.   "
7549|NCT03187067|"     The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of     childhood pneumonia in developing countries   "
7550|NCT03187054|"     The objective of the Preoperative Pelvic Organ Prolapse Quantification (POPQ) versus     Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of     Transvaginal Apical Suspension (PREPARE) trial is to compare surgical outcomes of POPQ-based     surgery with simulated apical support-based surgery for anterior or posterior vaginal wall     prolapse at the time of transvaginal apical suspension.   "
7551|NCT03187041|"     Purpose: This research study seeks to determine whether surface pressures generated by     elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues     where major arteries and nerves lie. Additionally, investigators will also determine the     effects of prolonged tourniquet application on hand sensation using a controlled,     reproducible force stimulus. In conjunction, the investigators will also track changes in     skin surface pressures and pain levels over this prolonged tourniquet application.     Hypothesis: The investigators hypothesize the use of common elastic tourniquets used for     blood draws does not significantly impact sensation and will not elicit nerve or tissue     damage. Technologies used: Monofilaments and Pressure Sensor   "
7552|NCT03187028|"     Determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients     comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.   "
7554|NCT03187002|"     High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an     inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that     activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane     review of TENS for acute pain found inconclusive evidence. One previous abortion trial     comparing TENS to IV sedation only looked at pain control in the recovery room. We propose a     randomized controlled trial comparing TENS to IV sedation (in conjunction with local     anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome     will be perceived pain by Visual Analogue Scale (VAS) during cervical dilation.   "
7555|NCT03186989|"     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     IONIS-MAPTRx in patients with Mild Alzheimer's Disease   "
7556|NCT03186976|"     This is a pilot study to assess feasibility to conduct a multi-center, randomized trial to     examine the effect of aggressive risk factor control and arrhythmia trigger-based     intervention on the atrial substrate, which is involved in the development and maintenance of     atrial fibrillation (AF).   "
7557|NCT03186963|"     The purpose of this study is to determine wether postoperative immobilization is effective in     controlling the pain of patients with intra-articular distal radius fractures treated with     volar locking plate fixation. The study hypotheses is that postoperative immobilization does     not enhance the analgesia of these patients.   "
7564|NCT03186872|"     Anxiety disorders and depression are more prevalent in patients living with inflammatory     bowel disease (IBD) than in healthy controls. Approximately 40% of IBD patients have elevated     anxiety. Given the robust effectiveness of cognitive behavioral approaches for anxiety     disorders and the paucity or mixed findings of cognitive behavioral approaches for anxiety in     IBD, an integrated behavioral approach and combining face to face and online cognitive     behavioral modalities is recommended for IBD patients with anxiety.   "
7605|NCT03186339|"     Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five     European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120)     and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical     treatment only. All patient groups will fill in three different questionnaires to assess     quality of life in 5 different languages (English, French, German, Italian and Spanish). One     of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life)     questionnaire (TASQ).   "
8172|NCT03178916|"     The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the     term and premature newborn, particularly with regard to protection from infectious agents.     Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary     tract infections, necrotizing enterocolitis, and otitis media among breastfed infants   "
7558|NCT03186950|"     The pulp therapy in primary teeth is designed to eliminate the infection and keep the tooth     in a functional state until its natural exfoliation. An important step for the success of     endodontic therapy is the final restoration, which must seal the tooth, avoiding new     contamination. Thus, this study proposes to carry out a randomized clinical trial with     longitudinal follow-up of two years, in order to compare the degree of success of endodontic     treatment in primary teeth restored with two different techniques: composite resin (Filtek     Bulk Fill - 3M ESPE) or stainless steel crowns (3M ESPE). Success will be measured by     clinical and radiographic features of primary teeth treated with the different restorations     after 1, 6, 12 and 24 months. Among the secondary outcomes that will be assessed are the     quality and durability of restorations and the cost benefit of treatments. Patients who seek     the university clinics and require endodontic treatment will be invited to participate. The     sample unit is the tooth and these will be randomized in groups through a randomization list     created and distributed in sequential opaque envelopes. The envelope will be opened only     after the end of endodontic treatment, to ensure allocation concealment. The data will be     statistically analyzed using the Stata 12.0 (Stata Corporation, College Station, TX, USA).     The longevity of the treatments will be evaluated by estimating survival rates using the     Kaplan-Meier method. Differences between survival rates according to the type of endodontic     proposed treatment will be analyzed using the log-rank test. All other clinical variables     will be analized using Cox regression. The significance level for all analyzes will be 5%.   "
7559|NCT03186937|"     Given preliminary data demonstrating that methionine deprivation enhances cell surface     expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that     methionine restriction enhances its expression in triple negative breast cancer and to     establish the feasibility and acceptability of this dietary intervention in humans. This     study will also examine the effect of methionine restriction on cancer stem cells and     metabolic health.   "
7560|NCT03186924|"     This research program aims to comprehensively investigate the clinical, physiological,     metabolic, and molecular effects of reducing sedentary behavior in rheumatoid arthritis. This     4-month parallel-group randomized controlled trial aims to investigate the feasibility and     efficacy of a newly developed personalized intervention focused on replacing sedentary time     with light-(or very light-) intensity physical activity in rheumatoid arthritis. A multitude     of gold-standard techniques will be applied to evaluate the effects of the intervention on     several outcomes, including sedentary time (primary outcome), physical activity levels,     clinical parameters specific to each condition, cardiometabolic risk factors, immune     function, and health-related quality of life. In addition, skeletal muscle and blood samples     will be collected and a variety of molecular analyses will be performed to gather knowledge     on the potential mechanisms which underpin the response to this intervention.   "
7561|NCT03186911|"     Participants will complete a phone screen and then one laboratory session. After completing     in-person screening assessments, eligible participants will complete additional     questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the     session. Participants will then sample two e-liquids that vary in nicotine content from     little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the     subjective effects of each one. Participants will then complete a preference assessment where     they choose between the two e-liquids. Participants will be blind to the nicotine contents.   "
7562|NCT03186898|"     This phase III trial studies how well radiation therapy with protons works compared with     photons in treating patients with liver cancer. Radiation therapy, such as photon therapy,     uses high energy x-rays to send the radiation inside the body to the tumor while proton     therapy uses a beam of proton particles. Proton therapy can stop shortly after penetrating     through the tumor and may cause less damage to the surrounding healthy organs and result in     better survival in patients with liver cancer.   "
7578|NCT03186690|"     This study aimed to evaluate the clinical performance of White MTA (MTA, Angelus, Londrina,     Brazil) and Biodentine™ in pulp capping of cariously exposed mature permanent teeth.      The investigator performed a prospective longitudinal randomized controlled study of 60 vital     permanent teeth with deep caries from 50 patients. Patients were divided randomly into     Biodentine™ and MTA groups; patients with more than one offending tooth were treated with     both Biodentine™ and MTA. Teeth were assessed clinically and radiographically prior to the     procedure. Caries were excavated under local anesthesia, hemostasis was achieved after pulp     exposure using NaOCl and capped with Biodentine™ or MTA. Clinical and radiographical     follow-up were performed by a blinded calibrated evaluator after six months and one year   "
7579|NCT03186677|"     This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the     safety, pharmacokinetics and pharmacodynamics of ISU304/CB2679d in previously treated     hemophilia B patients.   "
7753|NCT03184402|"     The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of     Functional Dyspepsia.   "
7563|NCT03186885|"     Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle     interventions to reduce obesity. Few studies have been translated into rural settings or     among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for     urban Latino families. The FI is a 12-week behavioral modification program grounded in social     cognitive theory, designed to engage the whole family in lifestyle changes by developing     knowledge and skills in physical activity and healthy eating, building skills in goal-setting     and self-monitoring, and creating a supportive home environment. Researchers will engage     community partners in formative research to adapt the current FI for rural Latino families.     Two parallel delivery methods of the FI will be developed and tested: 1) in-person group     setting at a community center (FI-IP) and 2) home-based delivered remotely with technology     (FI-RT). Both will be designed to address the unique social, cultural and environmental     factors facing rural Latino families. The FI-RT will take advantage of innovative modern     technology and e-Learning to increase program availability, accessibility and participation     in rural settings. Researchers will conduct a 3-arm randomized controlled trial (RCT) to     compare effectiveness of the two delivery approaches on weight loss (primary outcome) and     energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus     control. The researchers will recruit 270 obese Latino adults (ages 21-65) with a child (ages     8-17) from three primary care practices in rural South Texas. These parent-child pairs will     be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI-RT (n=90); or     3) control group (n=90). Primary specific aims are to: 1) Conduct community-engaged formative     studies to transform the existing FI into two unique delivery methods (FI-IP and FI-RT) for     use in a subsequent RCT in a rural Latino community; and 2) Conduct a RCT to evaluate the     comparative effectiveness of FI-IP and FI-RT to address weight loss (primary outcome) and     energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with     adult participants in control group at immediate post intervention (3 months), after a     3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months     post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's     weight and energy balance behaviors.   "
27515|NCT02925585|"     The investigators will analyze biomechanical transformation of pelvic floor tissues and     support structures under affected pelvic floor conditions and repaired states after the     surgery.   "
7565|NCT03186859|"     Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition     where fat accumulates in the liver and can lead to inflammation and scarring. It mostly     causes no symptoms, however, in the most advanced cases there is an increased risk of liver     cancer or liver failure.      NAFLD is currently managed by weight loss and treating associated diseases such as diabetes.     No medicines have been licensed to directly treat it but bariatric surgery has been shown to     be usually beneficial, although it is unknown whether some operations are better than others.     It is also unclear whether this is due to general weight loss or other factors.      This study will be conducted in a hospital setting and aims to determine what changes in     liver fat and fat processing occur after pre-operative low calorie diet and the two most     common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.      Participants will have ten study visits, four of which may be combined with NHS appointments.     Participants will undergo investigations including MRI scans to measure changes in NAFLD and     DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo     mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be     added to allow changes in fat processing to be detected. In addition to samples taken as part     of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal))     will be used for research. Visits will take place before and after low calorie diet and     bariatric surgery.   "
7566|NCT03186846|"     In the last 25 years, there has been a lot of attention directed on reducing perioperative     morbidity and mortality by improving intraoperative monitoring and hemodynamic optimisation     of patients. Advanced monitoring devices and new parameters have shifted the focus of     anaesthesia management from macro- to micro circulation with the emphasis on the determinants     of oxygen delivery and tissue oxygenation. There is increasing evidence that long-term     outcome is improved by goal-directed optimisation of hemodynamic parameters (optimisation of     stroke volume and cardiac output by fluids and inotropic and vasoactive drugs). Besides, new     monitoring possibilities (depth of anaesthesia and cerebral and tissue oxygenation monitors)     and adherence to protocols have proved beneficial in reducing morbidity cognitive     dysfunction.      However, questions are raised what the optimal goals (healthy population derived normal     values, preoperative values, maximal values, restrictive fluid management) should be.     Secondly, all new methods were used separately and there is a lack of studies to show the     effect of combined (multimodal) monitoring on occurrence of cognitive dysfunction. All     gathered data indicate that the combined use of new methods with adherence to an appropriate     protocol might radically improve the perioperative management and outcome of high-risk     surgical patients.      The present study tests the hypothesis that intraoperative multimodal monitoring with     hemodynamic optimisation, BIS-guided anaesthesia and maintenance of optimal cerebral oxygen     saturation will reduce cognitive dysfunction.   "
7567|NCT03186833|"     The study addresses the hypothesis that a gradual build-up in arterial resistance and     microvascular endothelial dysfunction due to common comorbidities such as hypertension and     diabetes mellitus, on top of age related vascular and cardiac changes (mainly fibrosis and     hypertrophy), is responsible for HFpEF. The HFpEF syndrome is commonly seen in elderly     subjects (often females) with hypertension and diabetes.      The investigators will investigate the vascular function, cardiovascular performance and     myocardial fibrosis in different cohorts of subjects to try and prove this hypothesis. There     will be 5 groups of subjects, all ≥ 70 years of age, as follows:      A) Normal healthy volunteers without major comorbidities including hypertension or diabetes     B) Patients with hypertension only (without diabetes mellitus) C) Patients with hypertension     AND diabetes mellitus D) Patients with HFpEF. E) A parallel group of patients with Heart     Failure with reduced Ejection Fraction (HFrEF) group.      Arterial resistance measured by pulse wave velocity will be the primary measure and will be     compared between groups A to D. A separate comparison will be made between groups D and E.     Other secondary measures will focus on endothelial function (Laser Doppler measurements) and     other cardiovascular performance measures (peak VO2 by CPEX, 6-minute walk distance). Bloods     samples will be taken for NT-proBNP, high sensitivity Troponin T, Galectin 3 and also stored     for testing later for vascular biomarkers.   "
7568|NCT03186820|"     Knowledge of the precise location of endometriosis is essential for a successful surgical     treatment. MRI Susceptibility-Weighted Imaging (SWI-MRI) yields high sensitivity for blood     by-products detection. Since endometriosis lesions are haemorrhagic, and therefore rich in     blood by-products such as hemosiderin, SWI-MRI could be useful in the pre-operative     assessment of endometriosis, especially in superficial peritoneal lesion detection. The     purpose of our study is to evaluate the performance of SWI-MRI for the preoperative work-up     of endometriosis   "
7572|NCT03186768|"     The soap on a rope behavioral trial is a school-randomized trial to determine if a disruptive     cue (the soap on a rope hall pass) can influence hand washing behavior for students in     Namwala District, Zambia.   "
7573|NCT03186755|"     This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% & Ectoine 2.0%) and     Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal     allergic conjunctivitis in the pediatric population. Half of participants will receive     Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.   "
7583|NCT03186625|"     Recent studies highlight the participation of gut microbes in the pathogenesis of both     atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide     (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving     nutrient precursors abundant in a Western diet and the sequential action of gut microbiota.     Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks     in a variety of stable cohorts. The purpose of this study is to evaluate the efficacy of     traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of     TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary     intervention. 80 patients with ACS would be randomly allocated into interventional group(IG)     and control group(CG). The patients in the IG would be administered by oral Compound     pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the     placebo twice per day during the same period. All of subjects would be administered with     standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial     infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is     the plasma level of TMAO at 90-day follow-up. The second endpoint is the level of lipid,     score of The Seattle Angina, fecal DNA extraction and pyrosequencing.   "
7574|NCT03186742|"     Obstructive sleep apnea syndrome (OSA) is the most frequent sleep disorder characterized by     excessive decrease in muscle tone of the soft palate, the tongue and the posterior pharyngeal     wall. It leads to airway collapse. In cases of decreased airway passage hypoventilation     (hypopnea) occurs while periodic lack of airflow is called apnea. An obstructive sleep apnea     syndrome is recognized as an independent cardiovascular risk factor. OSA is very common in     patients with resistant hypertension. RAH is diagnosed when blood pressure remains elevated     despite simultaneous use of 3 antihypertensive agents from different groups of drugs at     optimal to maximum doses, including a diuretic.      In patients with OSA frequent episodes of hypoxemia during sleep result in the repeated     activation of the sympathetic nervous system. What is more, the episodes of respiratory     disorders increases in levels of aldosterone serum concentration with following sodium and     water retention and elevation of blood pressure finally. An increased aldosterone level also     stimulates synthesis of collagen, promotes stiffening of the arterial wall, myocardial     fibrosis with heart muscle remodeling and takes part in development of left ventricular     hypertrophy (LVH) - common complication of hypertensive patients with OSA. Several studies,     including the Sleep Heart Health Study have confirmed that severe OSA is associated with high     prevalence of concentric hypertrophy through sympathetic activation and vasoconstriction.      Eplerenone is a selective mineralocorticoid receptor inhibitor. It has no affinity for     glucocorticoid, progesterone and androgen receptors and therefore has lower risk of side     effects. Eplerenone lowers blood pressure and inhibits heart muscle fibrosis. The hypotensive     effect is caused by reduction of fluid retention. Probably, in patients with OSA, a reduction     of fluid accumulation especially at the level of the neck may contribute to lowering the     resistance in the upper respiratory tract and in that way it may help to decrease the     severity of OSA.      As LVH remains a strong and independent predictor of total mortality and death from     cardiovascular causes, in this study we want to assess whether the addition of Eplerenone to     a standard antihypertensive therapy will favorably change left ventricular geometry. We also     want to check if the addition the Eplerenone to a standard antihypertensive therapy could be     an effective therapeutic option for patients with OSA and RAH.   "
7575|NCT03186729|"     The study evaluates the effects of antithrombotic drugs (anticoagulant drugs or antiplatelet     drugs) for prevention of ischaemic events in patients with intracerebral haemorrhage.   "
7576|NCT03186716|"     The effects of colostrum on intestinal permeability in critical ill patients has not been     investigated. In current trial, intensive care unit patients with enteral feeding will     receive either enteral colostrum or maltodextrin as placebo.   "
7577|NCT03186703|"     The goal of the McMaster Optimal Aging Portal is to be a trustworthy source for health     information. The Portal team can see (through measuring analytics of website use) that     thousands of people are using the Portal and the knowledge-sharing strategies in place (email     alerts, Twitter and Facebook), with many more users added each month. Previous studies have     measured the quality and trustworthiness of health information available online; others have     studied the numbers and populations who use different types of information and how easy it is     to use and understand. This study builds on that knowledge to find out: if easy-to-understand     evidence-based messages reach members of the public, do these messages change what people     know and think to do to stay healthy (in this case, what they know and think to do to lower     their risk of cancer)?   "
7620|NCT03186144|"     1. Clinical description of a French cohort of patients with CHARGE syndrome.        2. Search any phenotype-genotype correlation in typical, atypical or incomplete form of the          syndrome        3. Using Next generation Sequencing, try to identify other genes involved in this syndrome,          as the CHD7 gene is involved in only 40-60% of cases   "
7621|NCT03186131|"     There has been no comparative data between oral ibandronate and oral ibandronate plus active     vitamin D   "
7580|NCT03186664|"     Spasticity is frequently experienced by people with Multiple Sclerosis (MS), negatively     impacting on patient's motor functional outcome, including walking. Currently, none of the     available MS disease-modifying medications has been shown to stop or reverse gait disability.     Recently the nabiximols has been tested for the treatment of spasticity and walking     impairment in MS. Nabiximols (trade name Sativex®) is an oromucosal spray formulation     containing 1:1 fixed ratio of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)     derived from cloned Cannabis sativa L. plant. The main active substance, THC, acts as a     partial agonist at human cannabinoid receptors (CB1 and CB2), and may modulate the effects of     excitatory (glutamate-GLU-) and inhibitory (gamma-aminobutyric acid -GABA-)     neurotransmitters, leading to muscle relaxation, which in turn is responsible for spasticity     improvement. Cannabinoid receptors may modulate both excitatory and inhibitory transmission     at central synapses, and have been heavily implicated, in animal models, in multiple forms of     synaptic plasticity, such as long-term potentiation (LTP) and long-term depression (LTD).     Indeed, in a previous study implying transcranial magnetic stimulation (TMS) technique, it     has been hypothesized that the activation of cannabinoid receptors by Sativex® could modulate     the balance between LTP and LTD like plasticity by changing the state of cortical     excitability. In a recently study it has been proposed that Sativex may modulate the cortical     excitability changing the activity of inhibitory GABAergic cortico-cortical synapses. Aim of     our study is to clarify the role of Sativex coupled to a robotic neurehabilitation training     in MS patients in improving the motor outcome, by means of clinical, kinematic, beside some     neurophysiological and measures.   "
7581|NCT03186651|"     This is a prospective, randomized, controlled, two-armed multi-center pre-market trial.     Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress     urinary incontinence (SUI), will be considered as potential study participants. After written     informed consent has been acquired, a medical and surgical history, a physical examination     (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed,     followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling     all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or     the standard of care (SoC) group.   "
7582|NCT03186638|"     This randomized phase II trial studies how well exercise and low-dose ibuprofen in improving     cognitive impairment in patients with colorectal cancer that has not spread to other places     in the body who are receiving chemotherapy. Anti-inflammatory agents, such as ibuprofen, may     slow the decline of cognitive processes and diseases involving the brain. Exercise may also     help alleviating cognitive difficulties during chemotherapy.   "
7602|NCT03186378|"     The primary objective of the study is to determine the systemic presence or absence of VP-102     topical film forming solution when applied to molluscum contagiosum lesions in subjects 2     years of age or older from a single 24-hour dermal application. Treatment will continue over     the course of 3 additional 21 day intervals allowing for further evaluation of safety,     efficacy and impact on quality of life.   "
7603|NCT03186365|"     Grazoprevir plus elbasvir 12 to 16 weeks is now approved for chronic hepatitis C (CHC)     genotype 1, 4, or 6 infection regardless liver disease severity. The current study aims to     explore the efficacy and safety of 8-week grazoprevir/elbasvir in HCV-1b patients with mild     liver fibrosis   "
7584|NCT03186612|"     Introduction. Multiple sclerosis (MS) is the most common neurological disease causing     disability in young adults. Neurorehabilitation is a fundamental aspect in the treatment     approach for MS, in which new technologies have gained popularity, especially the use of     virtual reality (VR), thanks to the therapeutic possibilities offered for patients with MS     presenting cognitive, sensitive and motor dysfunctions.      Aim. To analyze and compare an occupational therapy intervention (OT) compared with OT + VR     (OT+VR) on the manual dexterity of patients with MS.      Material and methods. 26 patients will be recruited. The control group (n=8) will recieve 20     conventional OT sessions distributed in two sessions per week. The experimental group OT+VR     (n=8) will recieve 20 sessions of VR interventions, twice weekly and lasting 30 minutes,     consisting of VR games accessed via the online webpage motiongamingconsole.com, including     Flip Out, Air Hockey, Partículas, Dunkit, Cuenta peces and Robo Maro, in addition to the     conventional OT sessions. Pre and post-intervention assessments will be based on the Purdue     Pegboard Test, the Jebsen Taylor Hand Function Test and the Grooved Pegboard Test.   "
7585|NCT03186599|"     A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The     study included 6 months baseline measurement, and 12 months intervention. Patients will be     assigned to high adherence or low adherence group. Then, through randomization, low adherence     patients will be assigned to the intervention or control group. Study Coordinator delivers     the intervention using the WALKON mobile application. Control participants receive usual care     with continuous monitoring using Medication Event Monitoring System (MEMS) device.   "
7595|NCT03186469|"     Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant     mortality, in part because they may not be the sole decision-maker for an infant's sleep     environment and position and they make seek advice from older female support people.     Investigators will conduct a randomized controlled trial of a educational intervention to     mitigate the risks of unsafe infant sleep practices across generations. Given the complexity     and variability of teen-SCG relationships, investigators will include an examination of     inter- and intra-personal factors that are key control variables or may mediate the uptake of     safe sleep recommendations. Investigators believe that the intervention will empower support     people to positively influence a teen mother's adoption of safe sleep recommendations.   "
7596|NCT03186456|"     The purposes of the study is to determine the safety and efficacy of treating acute ischemic     stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).   "
7586|NCT03186586|"     Objectives: To assess if the administration of ulipristal acetate (UPA) in users of the     levonorgestrel-releasing intrauterine system (LNG-IUS) with breakdown bleeding or abnormal     bleeding, could be able to inhibit the bleeding and if this effect will be sustainable up to     three months after treatment.      Material and methods: A total of 32 women aged between 18-45 years, users of the LNG-IUS with     breakdown bleeding, abnormal bleeding or prolonged bleeding (bleeding more than 14 days) or     episodes of bleeding with intervals less than 24 days). The study is an experimental, double     blind randomized (16 women will receive UPA 5 mg/day/5 days; 16 women will receive placebo/1     time/day/5 day). The women will invited to participated at the Family Planning clinic at the     day they consulted with the complaint of bleeding. That day they will allocated at random to     UPA or placebo group. They will oriented to fill out a bleeding calendar through 90 days     after the pill intake. In addition a ultrasonography scan will be perform before the first     day of pill intake and at 90 days after.      Statistical analysis: A a pilot study the sample was estimated in 26 women (13 at each group)     based at the estimative of success of 0.95 with UPA and 0.35 with placebo with significance     of 0.05 and power of 80%. The sociodemographic characteristics will be analyzed as mean and     SD and will compared through Mann-Whitney, Yates χ2 and Fisher exact tests as apropriate.     Also, a regression analysis (Poisson analysis) with the dependent significant variables. The     established level of significance will be p < 0.05.   "
7587|NCT03186573|"     This project aims to evaluate if after 14 days of grape juice ingestion there is improvement     of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will     be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling     simulations will be performed on 3 different days.   "
7588|NCT03186560|"     This is a single centre open label study measuring microcirculatory flux using Speckle     imaging Device.      Microcirculation will be measured using laser speckle contrast imaging, at baseline and with     the device active for 30 minutes in the wound, peri-wound and other point on the lower leg.     The same procedure will be done on all the different patient groups.      Temperature variations can be assessed using Infrared Temperature Scanner (Exergen DermaTemp     DT1001), a measurement will be taken at baseline, and then at 5 minutes interval during the     30 minutes activity of the device.   "
7589|NCT03186547|"     The aim of the proposal study is to answer the question of how to manage gummy smiles due to     hypermobile upper lip with less invasive and low risk level procedure . This trial will help     the practitioners and the patients in taking the convenient decision to correct the gumminess     to restore lip-gingival-dental harmony and enhance smile asthetics.   "
7590|NCT03186534|"     Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in     which rates of new HIV infections are on the rise. There has been a relative dearth of     research dedicated to understanding these health disparities between gay/bisexual and     heterosexual youth, and even less has focused on identifying factors that might promote     resilience against negative health outcomes. Understanding both risk factors and processes of     resilience is critical in developing efficacious interventions to improve health in this     population.      Through a grant from the National Institutes of Health, the investigators completed formative     research with young male couples. Qualitative interviews identified preferences for     couples-based intervention format and content. While coupled YMSM expressed some interest in     HIV prevention, participants were most interested in building relationship skills. Coupled     YMSM preferred group-based interventions in order to meet and learn from other couples but     had concerns about discussing personal topics in groups. Quantitative analyses found that the     rate of condomless sex in couples increased from adolescence to young adulthood. Further, the     influence of older partners, partner violence, and drinking before sex were strongest in     emerging adulthood. Informed by these, the research team developed 2GETHER, which aims to     reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a     four session program. The first two sessions are group sessions aimed at skills building, and     the second two sessions are individualized couple sessions aimed at skills implementation.     Modules address communication skills, coping with stress (both general and sexual     minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within     the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in     couples regardless of HIV status; couples learn to use behavioral and biomedical approaches     to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and     transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis     on the health of the couple.      The investigators completed a pilot trial of 2GETHER with funding from Northwestern     University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility,     acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized     pre-/post-test design because the goal was to evaluate feasibility, acceptability and     preliminary effects in a large number of diverse couples to inform a future efficacy RCT.     Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial     recruited a diverse sample of couples in less than one year and each program module receive     high ratings of acceptability during post-sessions evaluation and an exit interview. At the     2-week post-test, the investigators observed significant decreases in HIV risk behavior,     improvements in motivation to reduce HIV risk, and improvements in relationship investment.      The current study will conduct a randomized controlled trial (RCT) to test the efficacy of     2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that     aims to reduce HIV transmission risk by optimizing relationship functioning. The     investigators will conduct an RCT with 200 dyads (total individual N=400), who will be     randomized to receive the 2GETHER intervention or an attention-matched couples-based positive     affect promotion program.   "
7591|NCT03186521|"     To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to     the patient in terms of sedative drugs reduction and thus overall decrease in duration of     mechanical ventilation and the morbidity and mortality which is associated with it, without     altering patient comfort and tolerance of the environment. This, compared to the less     frequent assessments by doctors and thus regular adjustments during the day as opposed to a     fixed drug dose.   "
7604|NCT03186352|"     The problem of root caries has been increasing in last decades as the an average life     expectancy is rising. Due to progress of medicine and dentistry humans also maintain natural     dentition longer.      The aim of the study is to determine the effectiveness of photoactivated disinfection /     photodynamic therapy / photodynamic antimicrobial therapy in elimination of cariogenic     bacteria after manual root caries removal.      If proved to be effective in eliminating bacteria from prepared cavity PAD could be     incorporated in the protocol of treatment of root cavities.   "
8173|NCT03178903|"     The purpose of this study is to examine the efficacy of tDCS (transcranial direct current     stimulation) for increasing exercise adherence among low active individuals with elevated     depressive symptoms. The investigators expect that this project will contribute much needed     knowledge about the role that tDCS can play in changing the affective experience of exercise.   "
7592|NCT03186508|"     Enhancing children's sleep may be a novel approach for prevention of obesity and     cardiovascular (CV) disturbance. Observational studies with children demonstrate that short     sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with     children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes     in eating and activity behaviors and weight status, particularly for children who enhance     their sleep the most. Enhancing sleep may be particularly important for racial minority     children and those from lower socioeconomic backgrounds given their increased risk for short     sleep, obesity and CV risk factors. In this study two active obesity preventive interventions     will be evaluated: a) enhancing sleep alone (Optimize Sleep [OS]), and b) enhancing sleep     along with eating and activity behaviors that have demonstrated efficacy for obesity     prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy     dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred     four children 8-11 years old who are African American/black, primarily from low socioeconomic     backgrounds, and who sleep < 9.5 hours/night into a 12-month study will be enrolled. Children     will be randomly assigned to either OS or OS-Plus. Over the 6-month treatment phase, all     children will attend an 8-session treatment; monthly phone contacts will occur during     maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus relative to OS     on change in body mass index z-score (BMIz) at end of treatment. Secondary aims will assess     efficacy of OS-Plus relative to OS on additional cardiometabolic risk factors, eating and     activity behaviors. Exploratory aims will assess maintenance of effects at 12 months.   "
7593|NCT03186495|"     The trial is conducted in Europe. The aim of the trial is to investigate the steady state     exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate,     severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal     renal function   "
7594|NCT03186482|"     The purpose of this study is to look at the levels of three HIV medications: Descovy®,     Viread® and Rifadin® in the blood after drug intake has been stopped, in order to understand     how long these drugs persist in the blood. The study will specifically look at blood levels     of these three drugs after taking them every day for 28 days. Participants will take Descovy®     on a first stage, a combination of Descovy® and Rifadin® on a second stage, and Viread® on a     third stage. If the participants decide to take part, the duration of the study will be up to     85 days plus a screening visit which will take place up to 28 days prior to the start of the     study, and a follow up visit, which takes place 28 to 36 days after the last dose of study     medication. This study is not randomised which means that all participants will receive all     study medications in the same order. The participant and the study doctor will know which     study medications the participant is taking at all times during the study.      During the study, numerous blood samples will be taken which could cause inconvenience and     distress for patients. Every effort will be made by study staff to minimise this. There are a     lot of clinic visits during the study and three full days in the unit which may inconvenience     patients. However, participants will be made aware of this both verbally and in the patient     information sheet. Participants will also receive compensation for their time and travel     expenses whilst participating in the trial. Participants or participants' partners who plan     to become pregnant during the study will not be allowed to take part in the study. Further to     this (if applicable), participants must use effective contraception for the duration of the     study. Participants will have to adhere to other restrictions as detailed in the participant     information sheet. These restrictions will be explained in full to all participants.   "
7597|NCT03186443|"     Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic     neuralgia still need to confirm.   "
7632|NCT03185988|"     To seek the efficacy signals of trastuzumab in combination with chemotherapy in pretreated     patients of HER2 positive, relapse or metastatic carcinoma of digestive system as response     rate (RR) determined by the Investigator using RECIST 1.1, and provide evidence for phase III     clinical trial.   "
7598|NCT03186430|"     The primary research aim of this project is to test the effectiveness of a comprehensive,     evidence-based vaccine promotion toolkit implemented in the pediatric healthcare setting on     increasing the likelihood that adolescents in Georgia will initiate and complete the Human     Papillomavirus (HPV) vaccine series. Secondary research aims include assessing the impact of     the comprehensive toolkit on 1) patient and parent knowledge and attitudes regarding HPV     vaccine, and 2) provider recommendation of HPV vaccine for males and females in the     recommended age range (11-12 years). The intervention toolkit will include evidence-based     components aimed at the practice-level, provider-level and parent-level that will be tested     through a cluster-randomized trial design. The primary hypothesis is that implementation of     the comprehensive vaccine promotion toolkit in the pediatric health care setting will     increase the likelihood that an adolescent receives initiates HPV vaccination.      At the initial visit, parents of adolescent patients at participating pediatric practices     will complete a brief questionnaire assessing their knowledge, attitudes, and beliefs about     adolescent health, including protection against infectious diseases during adolescence. The     parents will be contacted again three months later to complete a short follow-up interview on     the general health of their adolescent child, immunization status, and attitudes regarding     vaccination.   "
7599|NCT03186417|"     This is a prospective, multicenter, double-blind, placebo controlled interventional study to     evaluate the safety and efficacy of allogeneic mesenchymal stem cells (MSCs) in 20 patients     with new onset Rheumatoid Arthritis (RA). The study is a single dose, phase I clinical trial     and is the first time that this product will be infused in RA patients. The study duration is     approximately fourteen months from time of screening to completion.      Research hypothesis: The investigators hypothesize that when administered therapeutically,     MSCs will induce healthy immune responses and will reduce RA disease activity. This study is     primarily focused on demonstrating the safety of this approach.   "
7600|NCT03186404|"     Anthracycline (AC) chemotherapy has substantially reduced the mortality rate from several     common cancers globally. Unfortunately, AC treatment is associated with up to 19% risk of     heart failure (HF). Current standard of care for preventing AC induced HF (AIHF) is cardiac     surveillance followed by initiation of treatment once HF is diagnosed. With this approach 89%     of patients fail to recover heart function and 46% will experience adverse cardiac events.     Therefore there is a need for effective preventive therapy to reduce the risk of AIHF. Based     on small human studies, animal studies, and our own pilot data, statins are an ideal class of     drug for this purpose.      We will conduct a pilot double blinded, placebo controlled, randomized controlled trial to     assess whether pre-treatment with statins before AC can prevent heart dysfunction. Eligible     patients with cardiovascular risk factors scheduled to receive AC will be recruited. They     will be randomized to statin therapy or placebo and followed until the end of cancer     treatment. Primary outcome is the difference in cardiac MRI-determined left ventricular     ejection fraction between pre-AC and end of treatment.   "
7601|NCT03186391|"     The aim of this study was to evaluate exercise testing in case of patients suspected of     Peripheral Artery Disease (PAD).   "
7606|NCT03186326|"     Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer     appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC     representing approximately 15% of the CRCs exhibits a high mutational load which generates     many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found     in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis     than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific     immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i)     the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is     controversial.      Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even     chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1     alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4)     was tested in the MSI CRCs and a selection of interesting results in heavily pretreated     patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy.      Anti-PD1s now have marketing authorization for patients with melanoma and metastatic     pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be     as promising in MSI CRCs as in other tumors and therefore face the same major challenges.      Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with     promising results and is currently being studied in phase III in gastric cancer. There is no     data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used     in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The     main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the     2nd line of treatment in patients with a MSI mCRC progression after standard 1st line     chemotherapy +/- targeted therapy.   "
7607|NCT03186313|"     A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined     single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir & Ribavirin) versus Sofosbuvir     + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir &     Daclatasvir) versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults with Chronic     Genotype 4 HCV Infection.   "
7609|NCT03186287|"     The purpose of this study is to investigate and compare the effects of eccentric and     concentric strength training on pain, strength, joint position sense and function in patients     with subacromial impingement syndrome.   "
7610|NCT03186274|"     This study will evaluate how the educational intervention utilized affects pediatric resident     comfort level with EOL discussions.   "
7611|NCT03186261|"     -  The teeth of the patients that meet inclusion criteria will be anesthetized, isolated          with a rubber dam.        -  Cavity opened using conventional high-speed rotary instruments.        -  The central cariogenic biomass and the superficial parts of the necrotic dentine will be          removed with round burs.        -  Caries lesion will be completely removed in the enamel/dentin junction.        -  The excavation procedure will be terminated as soon as the soft and wet dentine was          removed and the remaining tissue was leathery but not hard on exploring.        -  A dentinal sample will then be collected from the base of the cavity using sterile spoon          excavator as a baseline for bacteriological assessment.        -  Then, application of either intervention or control agent, another dentinal sample will          be collected using a sterile excavator and transferred into sterile tubes and          transferred to the laboratory for microbiological analysis.        -  Filling of the cavity with resin composite restoration.        -  All clinical procedures will be carried out at the same visit.   "
7612|NCT03186248|"     Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3     cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an     additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM     procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy.     Hypothesis is that performing short myotomy will result in similar efficacy in achalasia     cardia while reducing the total time taken for the procedure and ultimately will result in     less complications.   "
7613|NCT03186235|"     Chronic hepatitis C infection is a global worldwide health problem with an increasing burden     year-by-year, particularly in areas with a high endemicity like Egypt . The World Health     Organization estimates that approximately 200 million people worldwide are infected with     hepatitis c virus. In Egypt, it was estimated that 15 % of Egyptians have serologic evidence     of hepatitis C viral infection .   "
7614|NCT03186222|"     Acne vulgaris is one of the most common skin diseases. It is a disease of the pilosebaceous     units, clinically characterized by seborrhea, comedones, papules, pustules, nodules and, in     some cases, scarring.   "
7615|NCT03186209|"     This is a randomised, double-blind, parallel group, placebo-controlled study designed to     evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered     subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma     receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA)     with or without oral corticosteroids and additional asthma controllers.   "
7616|NCT03186196|"     The C677T polymorphism of the MTHFR gene is associated to several biochemicals imbalances, as     changes in folic acid serum levels and some inflammatory markers, elevating the oxidative     stress and increasing the risk of developing non communicable diseases (NCDs).      Thus, a diet containing folate as a main antioxidant nutrient, could reduce not only the     oxidative stress, but also has many others benefits for individuals with this genetic     alteration, like the anti-inflammatory function, which could help restore the altered serum     levels and minimizing or avoiding the development of future diseases.      The aim of this study was to evaluate the influence of the C677T polymorphism of the MTHFR     gene and the effect of a diet containing folate in the inflammatory markers levels, such as     homocysteine, Tumor Necrosis Factor alpha (TNF-α) and interleukins in women with overweight     or obesity. This is an intervention study, double-blind, held in a city in northeastern     Brazil, with a sample of 48 adult women (20-59 years old) with BMI among 26.19 kg / m² and     49.64 kg / m². In which we evaluated the TNF-α levels, Interleukins 1β, Interleukin 6,     Interleukin 8, Interleukin 12p70, Interleukin 10, homocysteine, folic acid and in addition to     these markers evaluation, were made the genotyping for the C677T polymorphism in the MTHFR     gene and the food consumption assessment by the 24 hour dietary recall (24HR). For the     intervention, the sample was divided by randomization into two groups, each one with 24     indivuals, receiving daily during 8 weeks, a salad with 300g vegetables containing 191 ug of     folate for group 1 and 90 ug for group 2.   "
7666|NCT03185533|"     Emergency department (ED) crowding has become an international challenge in the recent     decades.      Length of stay (LOS) is a useful marker to monitor ED crowding. Searching for the possible     causes and reducing barriers may have the greatest impact on EDLOS.      Therefore, the investigators assembled a multidisciplinary team for improvement of the ED     process, to undergo assessments of ED patient flow with the spirit of lean-sigma     methodologies. The objectives of this study were to evaluate a Lean-sigma-based initiative to     lessen EDLOS.   "
7617|NCT03186183|"     GPS is a sexual health promotion and HIV prevention peer-delivered counselling program. The     GPS program has 4 parts: information provision about HIV and sexually transmitted infections,     motivational interviewing counselling, sexual health behavioural skills building, and linkage     to care. The adaptation grant has three goals: 1) to establish a multi-region and     multi-sectoral team that can deliver the revised program across a variety of settings, 2) to     learn how best to deliver this program as individual counselling program and also how to     adapt this program for HIV-negative MSM, and 3) to pilot the individual program in 5 settings     across Ontario and British Columbia. The research team will evaluate the pilot adaptation     through mixed methods, employing a quantitative questionnaire and one-on-one semi-structured     interviews.   "
7646|NCT03185793|"     The objective of the study is to assess efficacy and safety of SHR4640 in subjects with     hyperuricemia.   "
7622|NCT03186118|"     This study will enroll patients who have been enrolled into study PLAT-02 and meet the entry     criteria for study PLAT-03.      Patients with relapsed or refractory CD 19+ leukemia who have achieved remission after CD19     CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over     time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs)     at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and     reduces the incidence of leukemia relapse.   "
7623|NCT03186105|"     The investigators will conduct a monocentric prospective preliminary study evaluating the     feasibility of appendectomy for simple acute appendicitis in a cohort of 6-17 year-old     children presenting to the emergency department of the Hôpital Pédiatrique de Nice CHU-Lenval     (Lenval Childre Hospital, Nice) on a Period of 1 year.   "
7624|NCT03186092|"     Pulmonary hypertension (HP) is a progressive pathological condition presents with vascular     changes in the lung. Cardiopulmonary changes in PH are considered the main limiting factor,     however, it is known that the muscular alterations potentiate the symptomatology. Several HP     factors and mechanisms have an impact on peripheral and respiratory muscle changes, so,     specifically, respiratory muscles are also altered in patients with PH.      In the face of respiratory muscle weakness, inspiratory muscle training (IMT) has been shown     to increase respiratory muscle strength and functional capacity in chronic conditions such as     obstructive pulmonary disease (COPD) and heart failure (HF).      The objective of this study is to test whether a 12-week TMI protocol is capable of impacting     functional capacity, respiratory muscle strength, spirometric values and quality of life in     patients with PH.   "
7625|NCT03186079|"     Constipation is the most common complaint in childhood gastrointestinal disease,affecting an     estimated 20% of the global children.The treatment strategies consist of diet     control,behavioural intervention and oral and sometimes rectal laxatives. Given higher     success rate and fewer side effects,the laxative PEG3350 has been considered the first choice     in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting,     additional treatment interventions are still necessary.With an unsatisfactory response to     current treatments, many patients seek help from Chinese Herbal Medicine.In view of the     traditional theory, childhood constipation is derived from weakness of gastric and splenic     function.The functional weakness is characterized by food stagnation and further pathological     heat accumulation in the gastrointestine. The food stagnation can slow the gastrointestinal     motility while heat causes constipation by drying the intestines and their content.     Therefore, the therapeutic principles and practices for childhood constipation must focus on     the pathophysiological basis accordingly. In the documented traditional medicine     dictionary(Pi Wei Lun), Xiaojidaozhi Decoction is well described in improving the gastric and     splenic function, eliminating food stagnation and removing pathological heat accumulation,     and it has always been used in treatment of constipation throughout Asia since the first     description in Pi Wei Lun in 1249. It comprises twelve herbs. Through the combined action of     these herbs, Xiaojidaozhi Decoction can increase fluid in the intestines and facilitate the     gastrointestinal motility, relieving the symptoms of constipation. Despite of the long     history of successful use of Xiaojidaozhi Decoction in childhood constipation, a large     randomized placebo-controlled trial is still not available.The aim of this study was to     explore the clinical efficacy and safety of Chinese herbal medicine Xiaojidaozhi Decoction in     the treatment of childhood constipation.   "
7626|NCT03186066|"     Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients     with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper     Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma     chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of     patency, fixation of the PEG and possible leakage around the PEG.      BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic     submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo     device, which is inserted over the PEG and then is used to radially dissect the overgrowing     tissue with a cutting wire.      In this study both methods, the standard method using an ESD knife and the Flamingo device,     are compared in a randomized controlled open-label trial. Primary endpoint is the time needed     for PEG removal.   "
7627|NCT03186053|"     To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in     patients undergoing valve surgery   "
7628|NCT03186040|"     Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).   "
7629|NCT03186027|"     The main aim of the study is to examine the effect of oral CoQ10 plus NADH (Reconnect®)     supplementation twice daily for 8-weeks on the changes in fatigue perception, sleep     disturbances, autonomic dysfunction and HRQoL assessed by patient-reported outcome measures     in CFS/ME.   "
7630|NCT03186014|"     Dysphagia is the major symptom of patients with malignant esophageal stricture caused     predominantly by advanced esophageal cancer. Stent placement is the most commonly used     strategies for relieving the dysphagia and a novel irradiation stent loaded with 125I seeds     has recently been developed. A multicentre randomized clinical trial demonstrated this     irradiation stent can relieve the dysphagia rapidly and prolong the survival of patients with     advanced esophageal cancer, but the total stent stenosis rate cannot be ruduced. A novel     fully covered segmented retrievable irradiation stent was developed in our institute. The     purpose of this study is to evaluate the safety and clinical efficacy of this newly developed     irradiation stent in patients with unresectable malignant dysphagia.   "
7667|NCT03185520|"     This study seeks to determine the clinical characteristics of young ESUS patients using     diagnostic criteria of the Cryptogenic Stroke / ESUS International Working Group, and to     determine the rates of stroke recurrence, death, and hospital readmission in a contemporary     cohort of young ESUS patients during follow-up of up to 18 months.   "
8494|NCT03174717|"     The goal of this study is to examine the impact of an individualized music program that     includes music performance impacts quality of life, PRN drug use and scores on the RAI-MDS     for residents of a long-term care facility. The impact of this program on staff at the     long-term care facility and musicians performing at the facility will also be assessed.   "
7631|NCT03186001|"     The botulinum toxin was first identified in the late 19th century(1). With its 40 different     subtype this toxin is produced mainly by the gram positive anaerobic bacteria Clostridium     Botulinum(2). This neurotoxin has great affinity to the neuro muscular junction preventing     neurotransmitter release in the synaptic space of acetylcholine(3). The first clinical use     was reported by Alan Scott in 1980(4). The most commonly used subtype is toxin A commercially     found as BOTOX (onabotulinumtoxinA, Allergan, approved by FDA in 1989), Dysport     (abobotulinumtoxinA, Medicis, approved by FDA in 2009) and Xeomin (incobotulinumtoxinA, Merz,     approved by FDA in 2010). As for other commercial toxins botulinum neurotoxin serotype B     product (MYOBLOC™). Neurotoxin Blast generally 12-15 weeks compared to 3-6 month for     neurotoxin A. the FDA approved its use for strabismus in 1989(5), blepharospasm and     hemifacial spasm in 1990(6,7), cervical dystonia in 2000(8), glabella in 2000, hyperhidrosis     in 2004(9), chronic migrane and detrusor overactiviy in 2014. Other off-label uses have     emerged like lanyngeal dysponia, chronic pain etc… (10). Multiple studies with a reduced     number of patients have aimed to quantify the effect of botulinum toxin on brow higth. Some     studies used injections only to the lateral part of the orbicularis,while others added a     corrugator injection. We aimed in this study to compare a known techniques in brow lifting     and associanting that with 2 frontalis injection techniques. The main objective is to     evaluate the shape of the brow and the elevation in multiple brow landmarks before and after     the injection and to see if the frontalis botulinum bloc causes brow ptosis   "
7633|NCT03185975|"     This research study will recruit 200 transgender youths between the ages of 15-24. There are     two arms to the research study: the control and the intervention arm. Each eligible     participant will be randomized into either arm. The control arm participants receive an     OraQuick HIV testing kit sent to an address of their choice and instructions of how to     conduct the test. They will enter their results on the research study website and complete     surveys at 3 month intervals until an entire year has passed. Participants in the     intervention arm will receive an OraQuick HIV testing kit sent to them and will receive     video-based counseling called Motivational Interviewing and Certified Testing and Referral.     After this counseling session, the results from the OraQuick HIV test will be logged by study     staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals     until a year has passed.   "
7634|NCT03185962|"     Extubation failure can directly worsen patient outcomes. Therefore, the decision to extubate     is a critical moment during an intensive care unit (ICU) stay. The decision to extubate is     usually made after a weaning readiness test involving spontaneous breathing on a T-piece or     low levels of ventilatory assistance. However, extubation failure still occurs in 10 to 20%     of patients. The investigators focused on previously reported physiological risk factors, and     were able to obtain from common clinical practice: 1) age, 2) underlying cardiovascular     disease, 3) underlying respiratory disease or occurrence of pneumonia, 4) rapid shallow     breathing index (RSBI), 5) positive fluid balance during the previous 24 hours, 6) the ratio     of arterial oxygen partial pressure to fractional inspired oxygen, 7) Glasgow Coma Scale, 8)     respiratory tract secretions. The investigators aimed to assess the incidence and risk     factors for extubation failure among critically ill patients who passed the 30 min     spontaneous breathing test (SBT) using a low level of pressure support (PS) with positive     end-expiratory pressure (PEEP), in a prospective multicenter study.   "
7635|NCT03185936|"     To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined     with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade     in management of optic disc pit (ODP) maculopathy.   "
7636|NCT03185923|"     This study evaluates the integrated traditional Chinese and Western medicine in the treatment     of severe community acquired pneumonia in adults. Half of participants will receive     traditional Chinese and Western medicine in combination, while the other half will receive a     placebo traditional Chinese and Western medicine.   "
7637|NCT03185910|"     The purpose of this study is to explore the differences between stress, depression,     childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with     Mindfulness-Based Childbirth and Parenting education program.   "
7638|NCT03185897|"     Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe     hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia     B (coagulation factor IX [FIX] ≤2%).   "
7640|NCT03185871|"     The overall purpose of this study is to assess whether celecoxib can reduce the change in     collagen alignment and inflammatory response in the tumor tissue of primary breast cancer     patients with invasive breast carcinoma after 2 weeks of oral intake.   "
7641|NCT03185858|"     The aim of the study is to evaluate the effectiveness the SINEMA model via a one-year cluster     randomized controlled trial in a resource-poor rural area in China. The hypothesis is that     trained village doctors (VDs) and family caregivers, equipped with digital health technology,     can provide essential evidence-based care to stroke survivors in rural China.   "
7642|NCT03185845|"     Anticoagulation is the most important treatment for pulmonary thromboembolism (PTE). The     thromboembolism risk is especially high in patients with chronic obstructive pulmonary     disease (COPD) exacerbations. However, there's no agreement on the most appropriate duration     of anticoagulation in COPD with PTE to balance the risk of recurrence of thrombosis and     bleeding. This randomized, controlled trial aims to evaluate the risk and benefit of     prolonged anticoagulation compared with the regular 3-month anticoagulation in COPD with PTE.   "
7652|NCT03185715|"     Multiple pregnancies are considered an ART complication. The only effective way to reduce its     incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the     patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after     receiving the information about the similar cumulative live birth rate after single embryo     transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of     multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable     studies have been published in oocyte recipients. The aim of this study is to evaluate if the     information given to the patients influence their preference on the number of embryos to be     transferred. It also seeks to identify factors which determine the initial preference and     factors which can explain a hypothetic change in this preference.   "
30489|NCT02886637|"     The purpose of the present study is to evaluate the effects of immune function on prognositic     outcome in critical ill patients with Acinetobacter baumannii infection.   "
7643|NCT03185832|"     The purpose of this observational registry is to collect clinical events and outcome data in     4 different study populations (cohorts), with a majority of Japanese subjects, that are at     risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be     compared with available published data mainly from Europe and the United States.      Selected Subject Cohorts:        1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular          sustained arrhythmia) and de novo ICD device treatment.        2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac          resynchronization therapy (CRT) indication who received a de novo CRT-D device          treatment.        3. Selected subject cohort who are clinically expected to require >40% right ventricular          pacing with a left ventricular ejection fraction (LVEF) <50%, any determined New York          Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT pacemaker (CRT-P)          therapy despite previous device history (de novo, box changes, system revisions or          upgrades).        4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology          (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF <35%, having 2 to 5 predefined          SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D,          PM, or CRT-P.      The primary endpoint will report on the Composite rate of first appropriately treated     ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening     symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which     requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions     in a study population with a majority of Japanese subjects. This primary end point is     assessed in the ICD/CRT-D implanted patient cohort.      The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II     data) will be assessed in the PM/CRT-P patient cohort.      The All-cause mortality will be assessed in the non-implanted subject cohort.   "
7644|NCT03185819|"     The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses     of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive     placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD)     including suicidal ideation in participants 12 to less than 18 years of age who are assessed     to be at imminent risk for suicide.   "
7645|NCT03185806|"     The acute peripancreatic fluid collections (AFPCs) is the most common complication in severe     acute pancreatitis (SAP). There are controversies on optimal timing for drainage of APFCs in     SAP. The early-stage percutaneous catheter drainage (PCD) of sterile peripancreatic fluid     collections is questioned as a result of the major cause of secondary infection. The aim of     the present randomized controlled trial is to compare the outcomes in terms of mortality,     secondary infection of peripancreatic collections, organ failure, length of hospital/ICU stay     and inflammatory biomarkers between the early-stage PCD of sterile AFPCs and conservative     therapy.   "
7647|NCT03185780|"     Nearly a quarter of a million patients are diagnosed each year with tumors of the central     nervous system, a third of them malignant. The most common malignant tumor of the brain is     the high grade glioma( HGG), whose treatment begins with surgical resection of the tumor,     followed by a combined chemo-radiation regimen, with the drug Temodal (temozolomide). This     treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation,     weakness/fatigue, and others), with treatment of these effects limited in their effectiveness     and safety. Complementary medicine treatments such as acupuncture and touch therapies     (reflexology, Shiatsu, etc.) have been researched and found to be both safe and effective for     some of the toxic effects of oncology treatment regimens.      The present pilot study is set to examine the impact of complementary medicine on the toxic     effects of the conventional treatment for HGG. The study will include 40 patients and will     last for two years, during which patients will be treated with acupuncture and/or touch     therapies, this in parallel to their chemo-radiation regimen. The primary study outcome will     be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself     Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain     Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the     European Organization for Research and Treatment of Cancer Quality of Life Questionnaire     (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary     medicine treatments, and adherence to the planned oncology treatment regimen, as measured by     the Relative Dose Intensity (RDI) calculation.   "
7648|NCT03185767|"     the precise role of RNA in setting of this complication in systemic lupus erythematosus (SLE)     is largely unknown   "
7649|NCT03185754|"     A multi-center prospective randomized trial in Taiwan to investigate whether sublobar     resection, as compared to lobectomy, can offer equivalent clinical results to treat early     non-small cell lung cancer.   "
7650|NCT03185741|"     The investigators will leverage increasingly available technologies to impart a Universal     Medication Schedule (UMS) in primary care to help patients living with diabetes safely use     and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of     medicine by using health literacy principles and more explicit times to describe when to take     medicine (morning, noon, evening, bedtime). This eliminates variability found in the way     prescriptions are written by physicians and transcribed by pharmacists onto drug bottle     labels. The proposed intervention will standardize prescribing within an electronic health     record (EHR) so all medication orders include UMS prescription instructions ('sigs') and     patients receive both a medication information sheet and UMS-structured medication list with     after-visit summaries. Additionally, to help patients remember when to take prescribed     medicines we will link unidirectional short message service (SMS) text reminders to the EHR,     delivering medication reminders to patients around UMS intervals.        1. Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to          usual care.        2. Determine if the effects of these UMS strategies vary by patients' literacy skills and          language.        3. Using mixed methods, evaluate the fidelity of the two strategies and explore patient,          staff, physician, and health system factors influencing the interventions.        4. Assess the costs required to deliver either intervention from a health system          perspective.   "
7651|NCT03185728|"     This five-year study aims to improve childcare provider (CCP) reporting of suspected child     abuse by means of an online learning module, iLook Out for Child Abuse. Using an interactive,     video-based story-line (along with follow-up activities), iLookOut engages CCPs emotionally     and intellectually to take the first step in addressing the epidemic of child abuse -which in     the U.S. claims >680,000 confirmed victims annually. The consequences of child abuse can be     devastating and long-lasting. The purpose of this study is to establish an evidence-based     intervention that can help those who care for young children recognize and report suspected     child abuse before irreparable harm occurs.   "
7653|NCT03185702|"     The investigators will conduct genetic comparisons between Turner Syndrome (TS) patients with     and without Bicuspid Aortic Valve (BAV) to identify causative agents of BAV in people with     TS.      The investigators will correlate the patterns and prevalence of structural heart defects in     TS women with emerging molecular data to identify patients who are at high risk for     cardiovascular complications   "
7654|NCT03185689|"     In relation to rapid urbanization, demographic transition and childhood conditions obesity     and type 2 diabetes (T2D) is increasing in an alarming rate in Africa. With an increase in     the rate of diabetes in Ethiopia, responses to reduce its occurrence and delaying or     preventing complications is not adequate. One of these strategies is empowerment of diabetes     patients on self-care.      The main objective of this project is to assess effects of phased and intensified DSME on     psycho-social, clinical, and behavioral outcomes among adults with T2D in Ethiopia.      An interventional two groups study design was employed to determine the desired effect of     DSME. The study participants were selected randomly from adult T2D patients attending Jimma     University Medical Center (JUMC) chronic illness follow-up clinic. Using the assumption of     increasing the proportion of people with controlled blood glucose from 18% to 33% the sample     was calculated 120 with participants in the intervention group and 120 in the comparison     group.      To reduce risk of contamination, we planned to vary the intervention and the comparison group     based on their residence using kebele (the smallest administrative unit) for residents of     Jimma town and woreda or district for those outside of Jimma town. Because of the     inconvenience to vary days of appointment, where those supposed to come on Monday were coming     on Tuesday and those supposed to come on Monday were coming on Tuesday, that created a high     risk of mix-up of participants. Because of this reason, though the baseline was collected     from February 2016 to May 2016, the intervention was delayed by five months and then started     on November.      Face to face group-based DSME has been given to the intervention group from November 2016 to     April 2017. Then the participants will be further followed for three months to determine the     effect of phased and intensified DSME on the control of BGL as measured by HbA1c.      In order to make it culture-friendly educational materials were prepared with two widely used     languages, Amharic and Afan Oromoo. First, the teaching materials were prepared in English     then translated to Amharic and Afan Oromoo separately by bilingual experts. Then, different     bilingual experts back translated to English. Finally, with these experts, common discussion     was made and the final teaching materials were produced. The package of teaching materials     includes booklets, fliers, and posters prepared in both languages.   "
7657|NCT03185650|"     Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol     delivery device in healthy people using clinical measurements of mucociliary clearance.      Participants: 10 Healthy non-pregnant volunteers aged 18 to 65 (inclusive) with a body mass     index <30 kg/m² will enrolled.      Procedures (methods): 7% hypertonic saline (HS) aerosol containing the radio tracer     Tc99m-sulfur colloid will be delivered via the tPAD and compared to the well characterized     PARI LC Star nebulizer using planar gamma scintigraphy (i.e. particle clearance). The     fraction of sulfur colloid particles that clear over the ensuing 24 hours with each device     will indicate the fraction deposited in conducting airways.   "
7658|NCT03185637|"     Background: Five billion people worldwide do not have access to safe, affordable surgical     care. A significant proportion live in sub-Saharan Africa (SSA), where up to 50% of the     population are children. There is limited literature on neonatal and paediatric surgery in     SSA and children's surgery does not appear on any of the National Health Strategic Plans for     the 47 independent countries across SSA.      Objectives: To form a collaboration of surgeons and allied health professionals involved in     children's surgery across SSA and collectively undertake the largest prospective cohort study     of paediatric surgery in this region.      Materials and Methods: Data will be collected via REDCap website on all patients with     gastroschisis, anorectal malformation, appendicitis, inguinal hernia and intussusception,     during a 1-month period of collaborators choice between October 2016 to April 2017, with a     30-day follow up until the end of May 2017. Estimated study population: 1450 patients from 50     institutions. Full ethical approval has been granted by the host centre; local ethical     approval will be required at collaborating centres for participation. All collaborators will     be co-authors.      Primary outcome will be in-hospital all-cause mortality. Secondary outcomes will include     post-intervention complications. Data will be collected on institutional facilities, patient     demographics, duration from condition onset to presentation, peri-operative resuscitation,     intervention and outcome.      Differences in outcomes between SSA and benchmark data from high-income countries will be     calculated using chi-squared analysis. Multi-level multivariate logistic regression analysis     will be used to identify interventions and peri-operative factors associated with improved     outcomes; p<0.05 will be deemed significant.      Outcome: Results will be used to advocate for enhanced children's surgical services in SSA.     We shall identify context-appropriate interventions associated with improved outcome. The     collaboration will help to enhance research capacity in the region.   "
7659|NCT03185624|"     Some studies have shown that rifaximin is effective in the management of Crohn's Disease.     Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its     effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study     to assess the effect of rifaximin on preventing postoperative endoscopic recurrence in     Crohn's disease. The primary endpoint is the rate of endoscopic recurrence at 6 months.   "
7660|NCT03185611|"     Some studies have shown that rifaximin is effective in the management of Crohn's Disease.     Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its     effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study     to assess the effect of rifaximin combined with thiopurine on preventing postoperative     endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is     the rate of endoscopic recurrence at 6 months.   "
7661|NCT03185598|"     To find the threshold of First operating room SBP above which MACE risk increases.   "
7662|NCT03185585|"     The COAST nutrition screening tool will be validated in 300 community-dwelling older adults     in Florida.   "
7663|NCT03185572|"     Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease     (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD     and pulmonary hypertension may have pathological or genetics interactions so that patients     having both disorders tend to have poor prognosis. Echocardiography is widely used to detect     pulmonary hypertension, but it's not accurate enough. Therefore, high-quality data reflecting     the prevalence, disease course and outcome of pulmonary hypertension in COPD is very limited     in China. The aim of the study is to detect pulmonary hypertension with right heart     catheterization, describe its outcome in Chinese COPD patients and explore the underlying     interaction mechanism.   "
7664|NCT03185559|"     This study will evaluate the clinical performance and safety of a self-administered abortive     treatment for migraine headache using combined occipital and supraorbital transcutaneous     nerve stimulator (Neurolief device, Relievion™).   "
7665|NCT03185546|"     Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette     nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure,     puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco     dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other     tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate     differences between conditions in compliance with product use and the ability to abstain from     cigarette smoking when provided a financial incentive for abstinence from combusted tobacco.     This is not a treatment program for smoking.   "
8188|NCT03178708|"     During the surgical procedure of scoliosis correction, large surgery extent and long-lasting     strong nociceptive stimulation lead to postoperative pain formation of greater intensity     compared with other orthopedic interventions. In these patients, duration of postoperative     symptoms is longer, and may lead to persistent pain formation due to developing neuroplastic     changes in the central nervous system.   "
7668|NCT03185507|"     Upon suffering a concussion, a neurometabolic cascade including an increase in glucose and     oxygen demand occurs for up to 48 hours post-insult.5 This period of increased glucose and     oxygen demand is coupled with a period of hyperperfusion and decreased cerebral blood flow.     6-9 Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature,     blood flow, oxygen and metabolic demands.10-17 Cryotherapy following moderate or severe     traumatic brain injury has been demonstrated to decrease intracranial metabolic processes and     oxygenation consumption.18-23 Although the benefits of cryotherapy have been established in     moderate-severe TBI, the effects of superficial cranial cooling in individuals with and     without concussion are unknown. The purpose of this randomized control trial is to evaluate     the effects of superficial cryotherapy on cerebral blood flow and cognitive function in     healthy, recreationally active young adults.   "
21145|NCT03008798|"     Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal     medicine C117--PRISIT Trial   "
7669|NCT03185494|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous or donor-derived T cells may make the body build immune response to     kill cancer cells.      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in     treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell     transplantation or intensive chemotherapy) or refractory to chemotherapy.   "
7670|NCT03185481|"     The purpose of this study is to evaluate the long term safety and tolerability of PF-06649751     in Parkinson's disease patients who experience motor-fluctuations.   "
7671|NCT03185468|"     This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of     4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer     (UBC) who have no further treatment available.   "
7672|NCT03185455|"     Women with hypertensive disorders of pregnancy need postpartum blood pressure (BP)     surveillance to detect persistent hypertension. Various barriers result in only 30%     attendance at postpartum BP visits. A more effective strategy is needed. Women with     hypertension of pregnancy will be randomized to either text-based monitoring or office     visits. Those randomized to the intervention will receive a BP cuff and text in their BP to     an automated, clinician derived, HIPAA compliant text-based algorithm.   "
7673|NCT03185442|"     Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG     (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility     study (after which an interim analysis is done): 5 subjects in order to detect measurable     central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.   "
7674|NCT03185429|"     The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell     and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past     standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic     therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC     vaccine.   "
7675|NCT03185416|"     A mixed methods randomized control trial assessing the impact of early palliative care     incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being,     patient physical and psychosocial outcomes, and health services utilization.   "
7676|NCT03185403|"     Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension     than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is     essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this     study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient     undergoing oesophagectomy with laparoscopy and thoracotomy.   "
7677|NCT03185390|"     A periampullary lesion may be begin as duodenal adenoma, ampullary adenoma, gall stone     pregnant ampulla, Stricture, or periampullary lipoma, or malignant as pancreatic ductal     adenocarcinoma, distal CBD cholangiocarcinoma, ampullary carcinoma and periampullary duodenal     adenocarcinoma, pancreatic carcinoma.      The aim of the study is to detect incidence of different types of periampullary lesions     detected by ERCP in Assuit University Hospital and the role of ERCP in early detection,     diagnosis and management and diagnostic accuracy and sensitivity of biopsy and brush cytology     taken by ERCP in a period of 1 years starting from June 2017 to June 2018.   "
7678|NCT03185377|"     Chronic obstructive pulmonary disease (COPD) is closely related to venous thromboembolism     (VTE). But it is difficult to identify VTE in COPD patients in clinical practice. Therefore,     the prevalence data of PTE in COPD is limited. Pulmonary thromboembolism (PTE) is an     important factor effecting patients outcomes, but existing researches only have short     follow-up time less than 1 year. This study aim to develop an early detection system of PTE     in COPD and explore the disease course and prognosis.   "
7679|NCT03185364|"     Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary     hypertension. The current therapy focuses only on the basic disease and there are a lot of     controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our     study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug,     could be efficient and safe in improving symptoms and survival of severe pulmonary     hypertension caused by COPD.   "
7689|NCT03185234|"     The objective of the clinical trial is to investigate whether weak transcranial direct     current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke     rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham     stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient     stay in a rehabilitation center. Additionally, motor tasks are performed before and after the     stimulation. The effect of the weak current stimulation on motor function is assessed 3-4     days after the last stimulation and 3 months after enrollment.   "
7690|NCT03185221|"     Study purpose: This study is a prospective, randomized, controlled multicenter clinical     research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they     dealing with all kinds of complex lesions in the real world.      Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control     group: XIENCE V® Everolimus Eluting Coronary Stent System   "
8189|NCT03178695|"     The Inovium Ovarian Rejuvenation Treatment is a PRP-based autologous treatment used in     combination with a stimulated IVF sequence and Pre-Implantation Genetic Screening to treat     infertility in women experiencing menopause, perimenopause, and premature ovarian failure.   "
7680|NCT03185351|"     An effective brachial plexus block (BPB) provides a useful alternative to general anesthesia     for upper arm surgery producing complete muscular relaxation. It provides surgical anesthesia     in upper extremity surgery, post-operative analgesia and chronic pain management. In addition     to surgical procedure on conscious patients and early eating after the procedure make     regional anesthesia more attractive.      Brachial plexus block also maintains stable intraoperative hemodynamic and associated     sympathetic block. The sympathetic block decreases postoperative pain, vasospasm and edema.     The nerve of brachial plexus may be blocked anywhere along its course. The approach for     blocking brachial plexus nerve is interscalene, supraclavicular, infraclavicular and axillary     approach.      Supraclavicular approach for blockade of the brachial plexus is the most commonly used     approach in providing surgical anesthesia. In recent years, the technique has gained     importance as regional anesthetic technique for surgical, diagnostic and therapeutic purposes     in interventional pain management. It includes blocking of the brachial plexus where it is     most compactly arranged, with fewer requirements of the anesthetic solution and rapid onset     of action. Supraclavicular nerve block is technically easy to perform because of reliable and     fixed landmark but association of pneumothorax is a profound complication.      The extent of blockade following injection into the sheath surrounding the brachial plexus     may depend on the volume and concentration of local anesthetic (LA) used. Because of     bupivacaine long duration of action, it is used most frequently among local anesthetics for     BPB.      Inevitably, the effects of single-injection BPB dissipate after several hours unmasking the     moderate-to-severe pain of the surgical insult. Efforts to prolong BPB duration by increasing     LA dose are limited by their narrow therapeutic window and indeed may not be effective as     recent studies have demonstrated equivalent analgesic duration with volumes as low as 5 ml.      Midazolam is known to produce antinociception and potentiate the effect of LA when given in     neuraxial block. It produces this effect by its action on Gamma Aminobutyric Acid-A (GABA-A)     receptors and also on the peripheral nerves which contain these receptors.      Several studies showed midazolam to be effective when used in intrathecal, epidural and     caudal blocks and now recently midazolam with bupivacaine has been found to improve analgesic     characteristics in peripheral blocks compared to bupivacaine alone. Due to the high blood     concentration of benzodiazepine through conventional routes and profound sedation, proper     assessment of analgesic effect was difficult to obtain. With the advent of the less toxic     water soluble benzodiazepine (midazolam), it became possible to use it directly over the     nerve tissues.   "
7695|NCT03185156|"     This is a randomized, placebo-controlled trail, the objective of this study is observation     the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by     hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the     presence of post-delivery intra-operative nausea and vomiting in parturients. The patients     demographic characteristics, blood pressure, sensory block level, and the medications will be     collected.   "
9464|NCT03162185|"     With this study, the investigators aim to test whether acute administration of selective     serotonin reuptake inhibitors (SSRI) improves motor performance in a sequential motor     learning task in comparison to placebo in healthy humans.   "
7681|NCT03185338|"     Background:The lack of physical activity and increasing time spent in sedentary behaviours     during childhood place importance on developing low cost,easy-to-implement school-based     interventions to increase physical activity among children. The PREVIENE Project will     evaluate the effectiveness of five innovative, simple, and feasible interventions(active     commuting to school, Physical Education lessons, active school recess physical activity,     sleep health promotion, and an integrated program incorporating all 4 interventions) to     improve physical activity, fitness, anthropometry, sleep health, academic achievement,and     health-related quality of life in primary school children.      Methods:A total of 350 children (grade 3; 8-9 years of age) from six schools in Granada     (Spain) will be enrolled in one of the 8-week interventions (one intervention per school; 50     children per school) or a control group (no intervention school; 50 children). Outcomes will     include physical activity (measured by accelerometry), physical fitness (assessed using the     ALPHA fitness battery), anthropometry (height, weight and waist circumference), sleep health     (measured by accelerometers, a sleep diary, and sleep health questionnaires), academic     achievement (grades from the official school's records), and health-related quality of life     (child and parental questionnaires).To assess the effectiveness of the different     interventions on objectively measured PA and the other outcomes, the generalized linear model     will be used.      Discussion: The PREVIENE Project will provide the information about the effectiveness and     implementation of different school-based interventions for physical activity promotion in     primary schoolchildren.      Keywords:children, physical activity, school,active commuting, Physical Education, school     recess, sleep health, fitness, academic achievement, health-related quality of life.   "
7682|NCT03185325|"     Lymphomas are hematological malignancies, which are divided into non-Hodgkin lymphoma and     Hodgkin lymphoma. Non hodgkin lymphoma is a lymphoma-derived malignancy that makes up about     90% of all malignant lymphoma. According to its origin, non hodgkin lymphoma is classified     into B-cell non hodgkin lymphoma and T-cell non hodgkin lymphoma. The most common types are     follicular lymphoma, and diffuse large B-cell lymphoma. Lymphomas are types of cancer that     develops from lymphocytes, a type of white blood cell. Diagnosis is by examination of a bone     marrow or lymph node biopsy. Non hodgkin lymphoma mortality has increased in recent years and     has become the seventh most frequently occurring cancer.   "
7683|NCT03185312|"     The Janus kinase/signal transducer and activator of transcription (JAK-STAT) cytokine     signaling pathway is an emerging area of interest in dermatology, and emerging evidence     suggests that this pathway may play a crucial role in pathogenesis of inflammatory skin     disorders.      Recent advances on the role of cytokines in the pathophysiology of immune mediated     inflammatory diseases lead to the understanding that many pro inflammatory interleukins use     JAK/STAT components for signal transduction .   "
7684|NCT03185299|"     High quality bowel preparation is essential for successful colonoscopy. This study aimed to     assess the impact of reinforced education by Video on the quality of bowel preparation. This     prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced     education groups received additional education via reminders by video 2 days before     colonoscopy. The primary outcome was the quality of the bowel preparation according to the     Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate     (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.   "
7685|NCT03185286|"     This study aims to use 3D-printed personalized metal implants for bone defect surgeries in     order to reduce pain of the patients.   "
7686|NCT03185273|"     This is a prospective cohort study building upon the existing cohort study on the     effectiveness of the Trekkers Family Enhancement Scheme. This study will sample 200     low-income parent-child pairs and follow them up for 24 months with yearly assessment on     parental stress and child health using both subjective measures and objective physiological     parameters. Additional data on parenting style, neighbourhood cohesion, child physical     assault and neglect potential, parental mental health and HRQOL and family disharmony will     also be collected at each assessment time point for testing mediating and moderating     mechanisms between parental stress and child health. The baseline assessment will be carried     out in 2016-17 with three repeated assessments after 6 months, 12 months, and 24 months.   "
7687|NCT03185260|"     The aim of the registry is to collect laypeople's performance after a BLS/AED course carried     out with the use of feedback devices.   "
7688|NCT03185247|"     The proposed intervention is focused on developing and implementing a psychological approach     incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction.     The investigators hypothesize that their intervention will result in improvements in the     transdiagnostic mechanisms specifically targeted by components of their intervention     including sleep, information processing, and youth/parent experiential avoidance.   "
7691|NCT03185208|"     Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older.     AD leads to a complete loss of memory and independent function, and presently there is no     cure. Many studies suggest that lithium treatment may delay dementia onset or slow its     progression. However, more research is needed to understand the extent of its anti-dementia     properties if it will be deployed broadly in the general population. This study will examine     whether lithium has anti-dementia properties in older adults who have mild cognitive     impairment and are at risk of becoming demented.   "
7692|NCT03185195|"     This study is conducted to evaluate the absolute bioavailability, metabolism and elimination     pathways of AQX-1125 in healthy male and female subjects.   "
7693|NCT03185182|"     The main objective is to study whether imaging detection of the biomarker DAT can be used to     detect kidney tumors identified by computer tomography (CT), which are pathologically     assesses as being of the clear cell subtype.   "
7694|NCT03185169|"     The impact of treatment for GSM on the quality of life will be examined for postmenopausal     women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have     been diagnosed with breast cancer.   "
14197|NCT03099629|"     The purpose of this study is to investigate the effectiveness of inspiratory muscle training     (IMT) on respiratory performance in patients with esophageal cancer during combined modality     therapy.   "
7696|NCT03185143|"     The objective of this study is to compare side-by-side ALLOD-2 with sumatriptan, (a current     acute migraine standard of care treatment), in the acute treatment of migraine.      The investigational product (ALLOD-2), is a combination of two re-purposed marketed drugs     used for the acute treatment of migraine due to discovery of biologically and clinically     relevant affinity for new targets. Both drug are being re-purposed at a significantly lower     dosage compared to the maximum dose that has already been approved for the marketed     indications.      The combination is a First-in-Class drug due its new and unique mechanism of action.      The investigators propose that in predisposed individuals, migraine attacks occur due to     exuberant innate immune system activation nearby the trigeminal nerve and other cranial     nerves. The innate immunity activation leads to release of pro-inflammatory cytokines [nitric     oxide (NO), tumor necrosis factor-α (TNF-α), and reactive oxygen species (ROS)], and to COX-2     activation, which produces neuro-inflammation, causing pain and various migraine-associated     symptoms.      The investigation will focus on comparison of migraine-associated nausea, which has been     shown none-responsive to any of the other known migraine treatments, and is considered an     unmet treatment need.      ALLOD-2 reverses the neuro-inflammation through dual action, inhibition of the release of     pro-inflammatory cytokines and inhibition of the COX-2 activation. Efficacy of this product     for migraine headache pain and for migraine-associated symptoms, especially nausea, may     suggest the product addresses the root cause of migraine.   "
7697|NCT03185130|"     Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for     approximately 1.2 million migraine visits to US emergency departments per year . There are     numerous studies that discuss treatment for migraine and other benign headaches within the     emergency department (ED), however, there are very few that discuss specifically the use of     intravenous fluids (IVF) for headache treatment. Many of these studies look at various     options for treating migraine and other benign headaches: treatment options include dopamine     antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics     and ergot derivatives. Comparisons have been done between many of these treatment options     with dopamine antagonists appearing to be the most effective, compared to other treatments     The dopamine antagonist with the most evidence and availability for benign headaches is     prochlorperazine. Given that IVF administration is a common part of treatment regimen for     benign headache patients in the emergency department and given the lack of randomized trials     in adults, the investigators aim to study the use of IVF on pain reduction in headache     patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF     may help in patients with migraines, whereas the adult literature has no randomized control     trials and a review of data shows that fluids do not help relieve pain in migraine headache     patients. This study will include both adult and pediatric patients presenting to the     Emergency Department with complaint of benign headache.   "
7698|NCT03185117|"     At the Ohio State University, and across the country, surgical patients admitted to the     hospital are over-prescribed a significant amount of opioid medications upon discharge to     home. Recent studies reveal that a large percentage of patients prescribed opioid medications     after surgery have approximately half of the prescribed medication left over. This study aims     to evaluate reported opioid use after surgery in patients undergoing major orthopedic surgery     in order to better approach the issue with current opioid use and abuse trends while still     providing adequate medical care and pain management to patients   "
7699|NCT03185104|"     This study measures and compares the effect of silver diamine fluoride (SDF) on caries     increment in removable partial denture wearers. Half of the participants will SDF and while     the other half will receive placebo.   "
7700|NCT03185091|"     To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in     patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation     surgery.   "
7701|NCT03185078|"     The aim of this study is to observe the changes in the combined ESWT application and     physiotherapy program in the frozen shoulder pathology associated with diabetes. Different     treatment approaches will try to identify the most effective treatment method. Changes in     muscle tone will be observed with ESWT treatment. For the first time placebo-controlled     research is being conducted with different doses of ESWT in our country and in the World     literature. In this way the lower floor of the further work to be done will be established.   "
7702|NCT03185065|"     Randomized, placebo-controlled, crossover, 4-sequence, 4-period, double-blind (participants     and investigators), multicenter trial of 3 commonly used medications for treatment of     MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued     subjects with MS defined by McDonald Criteria.   "
7814|NCT03183596|"     The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs     blocks as well as the Serratus Anterior Plane Block have extended the application of     perioperative regional anesthesia to provide analgesia for breast surgery. However, to our     knowledge, there are no large studies that truly delineate the optimal injection site for the     Serratus Anterior Plane Block.   "
7703|NCT03185052|"     Over the past years, arterial closure systems have tended to replace manual compression to     ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce     hemostasis and patient immobilization times, thus enabling early resumption of walking. These     devices have contributed extensively to the development of outpatient stays for cardiology,     vascular and neuro-radiology procedures.      According to certain studies however, it would appear that arterial closure devices do not     present any greater benefits than manual compression in terms of hemostasis and     complications. Moreover, the use of increasingly small diameter instruments would tend to     render manual compression sufficient. Finally, the use of these devices generates additional     costs.      The purpose of our prospective study is to evaluate the feasibility and safety of same-day     discharge after manual compression in patients treated for peripheral artery disease by     endovascular technique with 5F sheath.   "
7704|NCT03185039|"     Prospective research of Matrix Metalloproteinases (MMP) 2 and 9 as predictive biomarkers in     metastatic kidney cancer patients treated with 2 anti angiogenic agents (Sunitinib or     Pazopanib).   "
7705|NCT03185026|"     The aims of the recent World Health Organization report, highlighting that every 40 seconds a     person dies from suicide somewhere in the world, are to increase awareness on the public     health significance of suicide and make suicide prevention a greater priority within the     global public health agenda. Across age groups, less than half of individuals at elevated     suicide risk interface with some form of mental health services. Several barriers to     help-seeking have been identified (maladaptive coping, lack of perceived need, beliefs about     treatment effectiveness, fear of hospitalization or mistrust of providers, stigma...), which     are key targets in knowledge-based interventions on suicide. Psychoeducational programs have     shown effectiveness in prevention relapse for several mental disorders such as schizophrenia,     bipolar disorder or recurrent depressive disorder, improving treatment adherence and     self-confidence in coping with symptoms of the disease. They are highly recommended for     addressing adherence problems in patients with serious and persistent mental illness. Only     one team has published a study protocol for a controlled trial assessing a 10 group sessions     psychoeducational program for prevention in patients having a suicide history, in a one-year     follow-up. Interestingly, diagnosis-mixed group psychoeducation have shown superiority than     an unspecific intervention add-on routine care, on the suicide prevention and compliance for     severe psychiatric disorders. Those psychoeducational-specific elements are namely the     interactive transfer of illness and treatment-related knowledge and management/coping -     cognitive/behavioral - strategies, as defined by the National Institute for Health and Care     Excellence)-Guidelines (NICE). Notably, as several psychiatric diagnoses are associated with     suicidal behavior (SB), coping strategies have to target processes that overlap among these     psychiatric disease, as well as suicidal vulnerability. Acceptance and Commitment Therapy     (ACT), a third wave behavioral therapy, targets experiential avoidance and psychological     flexibility, at the core of psychiatric disorders. Interestingly, in patients with a history     of suicidal depression, training in mindfulness can help to weaken suicidal thinking     associated with depressive symptoms , and thus reduce an important vulnerability for relapse     to suicidal depression. ACT would also increase intrinsic motivation for daily life action     (i.e. reasons for living and acting). Then, the functional analysis (matrix) used in ACT     seems to be an useful tool to help patient in decision making, a neuropsychological factor     impaired in suicidal patients. Finally, acceptance and commitment group therapy has suggested     effectiveness in reducing intensity and frequency of suicidal thoughts, through improvement     in acceptance, in high risk suicidal patients. As compared with ACT, Dialectical behavior     therapy (DBT) teaches added distress tolerance in view of survive the crisis. DBT is the most     validated therapy for borderline personality disorder, the mental disorder the most     associated with SB . Notably, group skills training is the most effective component in DBT     for preventing suicidal behavior in borderline patients with high suicidal risk. Furthermore,     interventions based on positive psychology have suggested efficacy in reducing depressive     symptoms and suicidal ideation. Notably, in a recent pilot study, positive psychology     exercises delivered to suicidal inpatients were feasible and associated with short-term gains     improvement in optimism and hopelessness. Finally, as altered social link and sense of     belonging have been widely involved in SB, relationship skills are an interesting positive     psychology area for suicide prevention program.      Psychoeducational program integrating knowledge as well the last innovating     cognitive-behavioral coping strategies for SB is of major interest in suicide prevention.      Investigators developed the first French program of suicide psychoeducation called PEPSUI.     The aim of this innovating program is to teach patients the more recent knowledge about     suicidal behaviour (SB) and effective treatments, through didactic and interactive sessions.     Thus, the objective is to conduct the patients to become experts and actors of their disease,     increasing adherence to treatment. Besides, the patients will experiment the last innovating     psychological skills to cope with unpleasant emotions and thoughts (including suicidal     thoughts), distress tolerance skills and crisis strategies, and identify personal purpose in     life and learn positive psychological skills in order to anchor with meaningful and pleasant     components in life. Thus, this program will include skills from ACT, DBT and positive     psychology. Finally, this primary care research is about a program which aim at improving     accessibility to mental health services, care adherence and continuity for suicidal patients.   "
14214|NCT03099408|"     We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is     better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis   "
7707|NCT03185000|"     Crohn's Disease (CD) is a condition that causes inflammation of the digestive system or gut.     Crohn's can affect any part of the gut, though the most common area affected is the end of     the ileum (the last part of the small intestine), or the colon.      Crohn's is a chronic condition. This means that it is ongoing and life-long, although     patients may have periods of good health (remission), as well as times when symptoms are more     active (relapses or flare-ups).      Current available therapies frequently fail to maintain long-term remission and may be     complicated by significant side effects.      There is an unmet medical need for novel therapies. Cellular therapies are emerging as     potentially attractive therapeutic strategies.      The TRIBUTE trial will use autologous regulatory T cells (Tregs) expanded in vitro.      It is hoped that the administration of this treatment to patients with active CD will change     the immune responses in the gut and reduce bowel wall inflammation.   "
7709|NCT03184974|"     During thoracic surgical procedures, while ventilating with a protective tidal volume, an     open lung approach consisting of a recruitment maneuver followed by an individualized     positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance     (Open-lung PEEP, OL-PEEP) would decrease driving pressure. To test this hypothesis, we     performed a multicenter observational study in 17 Spanish teaching hospitals of patients     undergoing one lung ventilation (OLV). In addition, we analyzed the association between the     driving pressure and the prevalence of postoperative pulmonary complications (PPCs), and     finally the association between the individualized PEEP and relevant patient preoperative or     intraoperative variables.   "
7710|NCT03184961|"     Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in     hypovolemic patients. The authors hypothesized that the changes of dynamic variables through     lung recruitment maneuver could predict preload responsiveness in pediatric patients with     lung protective ventilation   "
7711|NCT03184948|"     This study exploits the distribution of low-cost high-quality phototherapy devices     (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of     improved technology improves health care for infant jaundice. Specifically, the investigators     are interested in measuring whether the provision of an additional high-quality phototherapy     device, a known effective treatment for jaundice, successfully translates into improved care     of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.   "
7712|NCT03184935|"     The purposes of the study is to determine the safety and efficacy of human umbilical cord     mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.   "
7713|NCT03184922|"     Study Aims and Objectives:      To investigate the following null hypothesis: that there is no difference in clinical and     functional outcome when comparing outcomes of Anterior Cruciate Ligament (ACL) reconstruction     when comparing femoral side graft fixation with either a fixed versus an adjustable     suspensory loop system.      The research team will achieve this aim by:        -  Enrolling 150 patients into this study over a period of 2 years and 8 months        -  Carrying out a prospective randomised study looking at the subject matter over a period          of 5 years and 8 months        -  Analysing patients functional status pre and post-surgery using patient generated          questionnaires        -  Quantitatively measuring knee joint laxity using the KT1000 testing device at the 3, 6          and 12 month post-surgery time frames        -  Collating the data received into a spread sheet for analysis by a professional          statistician.      It is not uncommon to tear the anterior cruciate ligament (ACL) particularly during sporting     activities. Younger and sportier patients will often have this ligament reconstructed so as     to allow them to return to sport with a stable knee joint that they feel they can trust.      Various surgical techniques exist to perform ACL reconstruction. In Exeter, the favoured     technique is to reconstruct the ligament by taking two of the hamstring tendons from the back     of the knee and creating a graft with these, passing them through a bony tunnel to replace     the torn ACL. On the shin bone side of the knee the graft is fixed in place using a screw. On     the thigh bone side, the graft is attached to a device known as a suspensory loop.      The length of the graft and the length of the tunnel in the thigh bone vary from patient to     patient. It is important to get a good length of the graft material in both the shin and     thigh bones so as to give the best chance of the graft attaching to the surrounding bone.     With the fixed loop system, once the metal button attached to the outer thigh bone is in     place, the length of the loop cannot be adjusted. Thus the amount of hamstring graft in     either end of the bony tunnel cannot be changed. One potential advantage of an adjustable     loop system is that the amount of graft in either end of the bone tunnel can be altered to     ensure sufficient graft is accurately placed.      The research team are planning to run this study to identify which type of loop system gives     the best outcome for patients, examining the results in different ways including     questionnaires to measure how well the patients feel their knee is performing, and specific     tests to measure knee function.      If patients consent to be in the study, they will be randomly allocated to receive one of the     2 ACL reconstruction options above and their progress monitored for 2 years after the     operation. All aspects of surgical care will be as routine practice apart from the decision     to fix the graft to the thigh bone with an adjustable or fixed suspensory loop.   "
7714|NCT03184909|"     Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress     and anxiety. A randomised placebo-controlled clinical trial.   "
7715|NCT03184896|"     Hip fracture is a osteoporosis-related fracture with higher mortality, and is a major public     health issue in China. The British Orthopedic Association and the British Geriatric Society     have published the UK Blue Book, which summarizes current evidence and best practice in the     hip fracture care and secondary prevention, but this kind of standardized practice in hip     fracture care is not yet existed in China. The Blue Book standards will be used as the most     contemporary evidence-based guidelines for management of hip fracture.This study is to     prospectively examine the barriers and facilitators in the current management of hospital in     China by comparing the Blue Book standards.   "
7716|NCT03184883|"     comparing the effect of conventional mandibular single denture with flexible mandibular     single denture on tissue and patient's satisfaction   "
7721|NCT03184818|"     Pharmacists in some Canadian jurisdictions have recently been granted the ability to     prescribe for uncomplicated urinary tract infections (UTIs). Therefore, the purpose of this     study is to assess the impact that community pharmacists can have on the management of UTIs.      Pharmacists will identify potential study participants (patients) when they either present     with symptoms of a UTI (such as difficulty or painful urination, increased frequency or     urgency of urination) without a prescription for an antibiotic from another health care     provider, or when they present with a prescription for an antibiotic from another health care     provider to treat a UTI. For patients who consent to participate in the study, the pharmacist     will screen for eligibility and assess for appropriateness of treatment.      If the patient does not already have a prescription for an antibiotic from another health     care provider, the pharmacist will prescribe this for them if they meet certain criteria. If     they do already have a prescription from another health care provider, the pharmacist will     assess the appropriateness of the prescription and work with the patient to potentially     change it to make it more appropriate, if necessary. If the pharmacist identifies any     complicating factors that require a physician's assessment, the patient will be referred to     their physician. The enrolled patients will also have a 2-week follow-up to assess for     resolution of symptoms, unintended effects, and adherence to the treatment regimen. All data     will be collected in a web-based registry that will maintain the patient's confidentiality     outside of the pharmacy (i.e. patient initials, date of birth, and study identification (ID)     number will be the only patient identifiers collected by the researchers). A patient     satisfaction survey will also be administered via email.   "
7722|NCT03184805|"     Most previous trials support the absolute increase in bleeding risk with perioperative     administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative     major bleeding may be related to increase cardiovascular risk. The investigators will compare     the efficacy and safety of continuing versus stopping antiplatelet therapy during     perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next     generation DES(Drug Eluting Stent).   "
7723|NCT03184792|"     Stimulation of the spinal cord may induce the growth and reorganization of neural pathways     leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical     spinal cord stimulation improves motor functions immediately via modulating the excitability     of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive,     well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated     to be effective for improving lower limb motor function in healthy individuals and in     patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical     electrical stimulation can enhance conscious motor control and functions of hand and arm via     neuromodulation of spinal network.      This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation     for improving upper limb function in patients with traumatic or degenerative cervical spinal     cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the     United States Food and Drug Administration for treatment of spinal cord injury.      The interventions include either transcutaneous cervical spinal electrical stimulation     combined with physical therapy or physical therapy only. The order of the interventions will     be randomized for each subject in a delayed cross-over design. Total duration of the study is     6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks     follow-up. Both immediate and lasting improvements in hand motor and sensory function via     transcutaneous cervical spinal stimulation will be evaluated.   "
7724|NCT03184779|"     The main objective of the study is to investigate if a video intervention can help increase     knowledge, decrease risky behaviours on the hill, and reduce injury risk in students who     participate in ski and snowboard school programs. The study design is a cluster randomized     controlled trial where participating schools will be randomized into either an intervention     or control group. The intervention video will contain an injury prevention and safety     promotion component for skiing or snowboarding. The control group will receive the standard     orientation video that many schools typically provide for students prior to their     ski/snowboard outings in previous years.   "
7725|NCT03184766|"     This comparative pharmacokinetic study is being conducted to provide supporting evidence for     inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC     abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen & 30     mg pseudoephedrine).   "
7726|NCT03184753|"     The primary objectives are to evaluate the safety and efficacy of infusion of autologous     ovarian cancer immunogene-modified T cells (OC-IgT cells).   "
7727|NCT03184740|"     Technological advances and non-invasive techniques to modulate brain function have been     developed, including transcranial Direct Current Stimulation (tDCS). Basically, electrodes     are placed on the brain regions to stimulate or inhibit it. Subsequently, a continuous     electrical current (0.4-2 mA) is imposed, for a period of 3-20 minutes, to modify cortical     excitability. Few are the research groups that work on the topic of primary dysmenorrhea and     the use of tDCS as the focus of study. Preliminary studies associated the use of tDCS with     pain reduction, but the outcomes of physical and behavioral function needs further     investigation.   "
7728|NCT03184727|"     The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing     attention these days. Recent researches show that pulmonary vasculopathy and right heart     dysfunction relate to greater severity in COPD. Applying appropriate modalities for early     detection of pulmonary vasculopathy and right heart dysfunction is of great importance.     What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD     still needs to be further studied. The aim of our study is to develop an assessment system of     pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their     impact on COPD course and outcome.   "
7729|NCT03184714|"     Chronic obstructive pulmonary diseases (COPD) coexisting with obstructive sleep apnea is     called overlap syndrome (OS). Patients with OS seem to have worse prognosis than patients     with only one disorder. Noninvasive positive pressure ventilation is an efficient treatment     in obstructive sleep apnea, but the effectiveness in improving outcomes of OS patients is     still not fully investigated. The aim of this non-randomized concurrent control trial is to     evaluate noninvasive positive pressure ventilation's effectiveness in OS patients.   "
21182|NCT03008317|"     a split mouth randomized clinical trial that compares quantity and quality of bacterial     adhesion under both PEEK versus cobalt chromium alloy denture base.   "
7730|NCT03184701|"     End-Stage Liver Disease (ESLD) is one of the ten leading causes of death in US. It is marked     by episodic acute exacerbations of the underlying liver disease which often leads to severe     symptoms, poor quality of life, mental deterioration and repeated hospitalizations.      The overall purpose of this project is to introduce a telehealth based intervention     (involving remote monitoring of symptoms and cognitive function initiated at the time of     discharge of ESLD patients. This will support enhanced clinical care and improve     self-management in ESLD population. In addition, it will reduce healthcare utilization,     improve medication adherence and overall health outcomes   "
7731|NCT03184688|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Although many conservative     managements of CTS, the effectiveness of these methods is insignificant or only persist for a     short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients     with kinds of musculoskeletal disorders and recent reports showed being beneficial for     peripheral neuropathy in animal studies. Since 2014, four small clinical trials showed the     positive effect of PRP in peripheral neuropathy. Among these studies, two small trials showed     beneficial effect of PRP for patients with mild CTS. However, the definite clinical effect of     PRP for peripheral neuropathy from currently published studies is unclarified because these     studies enrolled a few patients and lacked long-term follow-up (no more than 6 months     follow-up).   "
7732|NCT03184675|"     This study aimed to examine the effects of functional action observation training on gait     ability in chronic stroke patients.   "
7733|NCT03184662|"     Type 2 diabetes is a chronic condition whose prevalence is increasing globally. Kidney     disease is a key complication of diabetes and is among the most common cause of end-stage     renal disease, requiring renal replacement therapy.      It has been shown that the trajectory of renal function (estimated glomerular filtration rate     - eGFR) is of great prognostic value for renal and cardiovascular endpoints in diabetic     patients. However the clinical use of this prognostic marker is not associated to date with a     clear therapeutic intervention, effective in patients with type 2 diabetes identified with     this biomarker.      In France, type 2 diabetes patients have twice less physical activity than non-diabetic     persons. Recently, it has been published that physical activity was associated with an     improvement of renal risk in patients with type 2 diabetes, recruited from the LOOK-AHEAD     study. It was demonstrated that high-intensity physical activity (HIPA) can have several     additional advantages over moderate-intensity, on blood pressure improvement, and     cardiovascular risk profile modification. In addition, this procedure was shown to be safe in     patients with high cardiovascular risk.      We plan to perform a randomized intervention comparing a structured program of high-intensity     physical activity (HIPA) vs standard recommendations for physical activity on renal function     decline (primary outcome) and mortality, renal and cardiovascular endpoints, patients' safety     and quality of life (secondary outcomes). Study participants will be patients with     established type 2 diabetes and a high renal risk, identified by rapid renal function     decline, defined as a eGFR slope below -5ml/min per 1.73 m2/yr. The intervention is planned     to last for 2 years.   "
7734|NCT03184649|"     The Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection     and Following Dental Extraction in Primary Molars: A Randomized clinical trial   "
7735|NCT03184636|"     Rationale:      To identify the prevalence of Acute-on-chronic liver failure in Zagazig University Hospitals.      The question of the research:      How much the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals?      The aim of the work:      The aim of the study is to identify the presence of Acute-on-chronic Liver Failure in Zagazig     University Hospitals      Objectives:      To estimate the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals.      Subjects and Methods:      I . Technical Design:        -  Site of the study: Gastroenterology and Hepatology Unit- Zagazig University Hospitals        -  Sample size: ''all patients admitted to Gastroenterology and Hepatology Unit with the          criteria of ACLF according to EASL-AASLD from June 2017 to December 2017 were included          in this study''.      II . OPERATIONAL DESIGN:        -  Type of the study: a prospective study.        -  Full medical history - taking.        -  Full clinical examination.        -  Laboratory investigations including Routine laboratory investigation  CBC, Liver          functions test, kidney functions test and prothrombin time       III. Administrative Design:        -  Approvals obtained for performing the study from the official or governmental          department.        -  An ethical committee from the faculty of medicine and patients included in the study.      Results:      Collected data will be presented in tables and suitable graphs and analyzed according to     standard statistical methods   "
7736|NCT03184623|"     ICUacquired weakness is a common complication of critical illness, particularly in patients     receiving mechanical ventilation and/or suffering from conditions leading to the systemic     inflammatory response syndrome. The weakness and disability that result from these     neuromuscular disorders can dominate the lont-term course and impede recovery.      In this observational study we try to measure muscle mass and body composition by     echocardiography and BIVA at admission and on day 2, 5   "
7737|NCT03184610|"     The OCT used in this trial offers the advantage of both a non-contact method and a very high     axial resolution. Determined parameters with the highest potential of diagnostic     discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this     trial is to investigate differences of specific parameters of epithelium thickness maps at     healthy eyes and eyes with Keratoconus.   "
7754|NCT03184389|"     The aim of this research is to build systems that can recognize when people are stressed and     then provide them with relaxation prompts in the moment to reduce their likelihood of being     stressed, smoking, or overeating in the near future. Using these systems should help smokers     be more effective in their attempts to quit by reducing their tendency to lapse when they are     stressed or experiencing other negative moods or behaviors.   "
7813|NCT03183609|"     This study purpose is to conduct a confirmatory double-blind randomized controlled trial in     an inpatient setting of the effects of a tightly controlled gluten-free diet (GFD) to improve     negative symptoms in people with schizophrenia or schizoaffective disorder who have     antibodies to gliadin (AGA IgG). As part of the project investigators will also confirm     outcomes such as cognitive symptoms, changes in peripheral and central inflammation as well     as gut/blood brain barrier permeability.   "
7738|NCT03184597|"     Cutaneous adverse drug reactions (cADRs) include mild maculopapular exanthema (MPE) and     severe cutaneous reactions such as hypersensitivity syndrome, Stevens-Johnson syndrome (SJS),     and toxic epidermal necrolysis (TEN). cADRs are considered as a major public health issue     because of their potentially life-threatening morbidity, especially severe cutaneous     reactions. The incidence of SJS/TEN is estimated to vary from 1 in 1,000 to 10,000 drug     exposures, and its mortality is as high as 35%. Antiepileptic drugs (AEDs), particularly     those with aromatic ring structures such as carbamazepine (CBZ), oxcarbazepine (OXC),     lamotrigine (LTG), phenobarbital (PB), and phenytoin (PHT), are among the most common causes     of severe cutaneous reactions. The incidence of AED-induced SJS was estimated as 0.2% and all     cases occurred in individuals receiving aromatic AEDs.      Previous studies have validated that the human leukocyte antigen (HLA) allele HLA-B*15:02 is     strongly associated with CBZ-induced SJS/TEN in southern Han Chinese and populations in     southeast Asia. Our recent studies indicated that HLA-A*24:02 is a common genetic risk factor     for CBZ-, LTG-, and PHT-induced SJS/TEN. It is also associated with MPE. Additionally,     another four alleles, including HLA-B*15:01, HLA-B*15:11, HLA-A*02:01,and HLA-DRB1*01:01,     were showed to be potential risk factors for aromatic AEDs-induced SJS/TEN. In 2007, the US     Food and Drug Administration issued the safety alert that recommended HLA-B*15:02 screening     for people with Asian ancestry before starting CBZ, and avoidance of the drug if the test is     positive. Subsequent studies from Taiwan, Hong Kong and Thailand demonstrated that     HLA-B*15:02 screening before commencing CBZ can significantly reduce the incidence of     CBZ-induced SJS/TEN. However, the overall incidence of AEDs-induced SJS/TEN remained     unchanged in Hong Kong, as PHT-induced SJS/TEN increased when CBZ-SJS/TEN decreased.     Moreover, no study focuses on the incidences of AEDs-induced cADRs with and without HLA     screening before commencing aromatic AEDs. Therefore, we are planning to conduct a     multicenter prospective study to examine the reduction of AEDs-induced cADRs after the HLA     screening prior to the beginning of aromatic AEDs administration.   "
7739|NCT03184584|"     Phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and     tolerability of PBI-4050 in subjects with Alström Syndrome who have completed a preceding     ProMetic-sponsored Alström Syndrome study with PBI-4050.   "
7740|NCT03184571|"     This is an open label, single arm, multi-centre phase II study to assess the anti-tumour     activity and safety of BGB324 in combination with pembrolizumab in up to 48 patients with     previously treated advanced adenocarcinoma of the lung. The study will utilise an extension     of Simon's 2-stage design. The primary objective is objective response rate.   "
7741|NCT03184558|"     This is an open label, single arm, multi-centre phase II study to assess the anti-tumour     activity and safety of BGB324 in combination with pembrolizumab in up to 56 patients with     previously treated, locally advanced and unresectable, or metastatic TNBC or TN-IBC. The     study will utilise an extension of Simon's 2-stage design. The primary objective is objective     response rate.   "
7742|NCT03184545|"     The purpose of study is to evaluate the efficacy of the electrical muscle stimulation (EMS)     device in patients with patellofemoral pain known as anterior knee pain. Usual treatment for     it is physical therapy (PT). We want to evaluate and see if adding the electrical muscle     stimulation will fasten the recovery and improved outcome in patellofemoral pain syndrome.     Half of participants will receive EMS and PT while other half will receive PT only.   "
7743|NCT03184532|"     To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of     liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used     to evaluate the volume and the nature of the stomach content. In its latest recommendations,     the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting.     The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients     using ultrasound (US) scanning of the stomach (antrum).   "
7744|NCT03184519|"     Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro     Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after     In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).   "
7745|NCT03184506|"     Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below     36°C. Intraoperative hypothermia can lead to serious clinical complications such as,     myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection.     Hypothermia develops easily during surgeries that require irrigation fluid, such as     laparoscopic surgery and transurethral resection of the prostate. Although isothermic     irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to     warm a large volume of irrigation fluid.      Re-distribution after induction of anesthesia is the most important cause of perioperative     hypothermia. The extent of re-distribution is proportional to the gradient between the core     and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal     compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis     suggested that as a single strategy, preoperative forced air warming had significant benefits     than other warming methods. Also, it was reported that only 20 (or even 10) min of     pre-warming mostly prevented patients from perioperative hypothermia under general     anesthesia. However, few studies have examined whether short time pre-warming can reduce     hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia.      The purpose of this study is to assess whether the application of preoperative forced air     warming set to high temperature (> 43°C) for brief period can prevent hypothermia or     shivering during procedures requiring large volumes of cold irrigation.   "
7746|NCT03184493|"     This prospective trial aims to compare the role of celebrex alone, metformin alone, and     celebrex plus metformin in preventing HCC recurrence after hepatic resection.   "
7747|NCT03184480|"     The aim of this post-marketing investigation is to collect and assess the information about     safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as Arnuity) in daily     clinical practice. The investigation will include subjects with a diagnosis of asthma     bronchial who are naïve to ARNUITY. The investigator will monitor the information about     safety and effectiveness of ARNUITY for one year from the start date of ARNUITY     administration and Pneumonia will be considered as the priority investigation matter. 300     subjects, from approximately 150 medical institutions, will be included in this analysis.     ARNUITY ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.   "
7748|NCT03184467|"     This clinical study is designed as a multi-center, randomized, double-blind,     placebo-controlled, parallel design, prospective, phase II clinical trial.      An eligible subject who meets inclusion and exclusion criteria is randomly assigned to three     groups: study group 1 (GV1001 0.56 mg), study group 2 (GV1001 1.12 mg) or placebo group. A     randomized subject is administered either GV1001 or placebo in a total of 14 times and will     be evaluated for the efficacy and safety at week of 24.   "
7749|NCT03184454|"     This study involves the use of the Medtronic PC+S deep brain stimulation for the treatment of     intractable OCD.   "
21183|NCT03008304|"     The aim of this study is the safety and efficacy of high-activity natural killer     immunotherapy to small metastases of pancreatic cancer.   "
7755|NCT03184376|"     This trial will investigate the therapeutic potential of a prebiotic supplement to improve     histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot     trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty     liver activity score (NAS) ≥ 5). Participants will be randomized to receive oligofructose (8     g/day for 12 weeks and 16g/day for 24 weeks) or isocaloric placebo for 9 months. The primary     outcome measure is the change in liver biopsy NAS score and the secondary outcomes include     changes in body weight, body composition, glucose tolerance, serum lipids, inflammatory     markers, and gut microbiota.   "
7756|NCT03184363|"     The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows     Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study     for CFL.   "
7757|NCT03184350|"     The APROVE study is a prospective single-center single-arm phase-II study. Patients with     cervical or endometrial cancer after surgical resection who have an indication for     postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly     used photon radiation. A total of 25 patients will be included in this trial. Patients will     receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active     raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered     if indicated. The primary endpoint of the study is the evaluation of safety and treatment     tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4     toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and     progression-free survival. The aim is to explore the potential of proton therapy as a new     method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder     thus reducing acute and chronic toxicity and improving quality of life.   "
7758|NCT03184337|"     This pilot study aims to determine whether adding a sleep extension and sleep hygiene     intervention to an existing lifestyle improvement program improves its efficacy for weight     loss in those at risk for diabetes and cardiovascular disease. Half of the participants will     receive the Centers for Disease Control's standard PreventT2 program and half of the     participants will receive the same program with an additional sleep intervention.   "
7759|NCT03184324|"     The purpose of this study is to determine the efficacy and safety of DWP14012 compared to     esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los     Angeles(LA) classification grades A to D.   "
7760|NCT03184311|"     This study investigates the effects of a 12-week high-intensity interval training (HIT) on     exercise tolerance, functional status and quality of life in patients with chronic heart     failure with preserved ejection fraction (HFpEF), in comparison to a control group continuing     to undergo usual care.   "
7761|NCT03184298|"     The proposed project will provide data concerning dating and sexual interactions that occur     on Fort Bragg, North Carolina. The investigators will be able to use data from this research     to develop a program that promotes health in men's sexual and dating relationships and     address the role of alcohol in sex and dating in subsequent research studies. The long term     goal of this research is to reduce rates of sexual assault in the military by providing a     sexual assault prevention program tailored to at risk male Soldiers that can be disseminated     across military posts.   "
7762|NCT03184285|"     Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive     and invasive (Masimo© ; Nexfin© Monitoring ; FloTrac© Edwards Lifesciences) beat to beat     measurement methods for the determination of arterial blood pressure in patients undergoing     bariatric surgery.   "
7763|NCT03184272|"     Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive     and invasive (Masimo©; Nexfin© Monitoring ; FloTrac © Edwards Lifesciences) beat to beat     measurement methods for the determination of cardiac output and fluid responsiveness in     patients undergoing bariatric surgery.   "
7764|NCT03184259|"     A new lower-limb training system is introduced to enhance the clinical service for     post-stroke lower limb rehabilitation and to assist the establishment of public clinical     trial in different settings and share experiences on the robot-assisted functional training.   "
7765|NCT03184246|"     The investigators suppose that direct laryngoscopy is connected with deeper insertion of     endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can     cause postoperative discomfort and further complications in some patients.Routine use of     videolaryngoscopy could minimize these problems.   "
7766|NCT03184233|"     Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time     during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood     pressure which presents as an on-off phenomenon. However it is not clear whether repetitive     periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be     undetected. The investigators will study the safety of RVP, particularly for the heart and     the brain.   "
7767|NCT03184220|"     This study aimed to investigate the effects of myofascial release therapy (MRT) for improving     pressure pain thresholds (PPTs), range of motion and pain in patients with mechanical neck     pain (NP).   "
7768|NCT03184207|"     In the operating room, most intubation procedures (IP) are scheduled and performed on     hemodynamiccaly stable patients. In the ICU, IP is frequently performed in emergent patients,     because of unstable hemodynamics and/or acute respiratory failure, and complicated by a     subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily     available in most ICUs for several years. Echocardiography enables to perform a noninvasive     hemodynamic evaluation (cardiac function and volemia status).      We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse     and its components.   "
7769|NCT03184194|"     Evaluation of the effect of nivolumab and daratumumab with or without     lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma.   "
7806|NCT03183700|"     The aims of the present study are to assess the effects of a hrHPV self-sampling test as     strategies to reach non-attending women in organized cervical screening in comparison with     standard recall by letter in 8000 women; to evaluate the performance of two self sampling     devices with and without a preservative buffer and to explore their acceptability among     invited women and to evaluate a molecular triage approach for management of HPV positive     women in self sampling collected material by HPV genotyping and DNA methylation marker panel   "
7770|NCT03184181|"     The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of     awareness about the options of the physiotherapist treatment. It is necessary to do studies     about effectiveness of therapeutic percutaneous electrolysis (EPTE®). This technique enables     treatment of the tendinopathies and the broken muscle fibrilare. It is base on the     application of galvanic current through a acupuncture needle. To analyze the effectiveness of     therapeutic percutaneous electrolysis (EPTE®) in the treatment of supraspinatus muscle     tendinopathy. Single center randomized controlled trial, parallel treatment design. A     specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants     will be randomly assigned to receive treatmen for 4 weeks: EPTE® associated with eccentric     exercises or dry needling with the same eccentric exercises. Both interventions were     performed under ultrasound guidance with a portable ultrasound (General Electric LogicE).     Data will be collected by a blinded evaluator.   "
7771|NCT03184168|"     This open-label, radiolabeled, single 100-mg dose study in 6 healthy male volunteers has been     designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel     study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in     plasma; a benzoic acid metabolite (M8) resulting from cleavage of the amide and aromatic     ether bonds of lorlatinib, accounting for 21.0% of the circulating radioactivity. However,     due to the position of the 14C radiolabel on the carbonyl carbon, the metabolic fate of the     larger fragment of lorlatinib resulting from this cleavage, the pyrido-pyrazole substructure,     could not be determined. In this current study, the radiolabel will be on the pyrazole ring     allowing for monitoring the metabolic fate of the pyrido-pyrazole part of the lorlatinib     molecule cleaved during the formation of the M8 metabolite. Since M8 will not be     radiolabeled, its concentrations in plasma will be determined using a validated assay.      The sample size of 6 was selected to ensure at least 4 fully evaluable subjects with     completed collections of plasma, urine, and fecal samples. This is a standard sample size     used for mass-balance/ADME studies which include assessment of metabolic profiling, and is     not based on empirical data or hypothesis testing criteria.      Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as     well as on cumulative urine and feces excreted until Day 14 postdose or until one of the     following early release criteria is met: 1) recovery in excreta of at least 90% of     administered radioactivity, or 2) less than 1% of administered radioactivity being recovered     in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2     consecutive days). Plasma concentrations of both lorlatinib and its unlabeled M8 metabolite     will be analyzed using validated assays. Information from this study will complement the     metabolic profiling results from study B7461004, will help guide in the assessment of     potential drug-drug interactions (DDIs) and the need for other DDI studies with lorlatinib.      Banked biospecimens will be collected for the purpose of conducting research. Collecting     biospecimens for exploratory analyses makes it possible to better understand the     investigational product's mechanism of action and to seek explanations for differences in,     for example, exposure, tolerability, safety, and/or efficacy not anticipated prior to the     beginning of the study.   "
7772|NCT03184155|"     This is a single-center double blind, placebo controlled study of patients undergoing a     cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is     anticipated or will be determined during the early diagnostic phase. The study will assess     the use of intracoronary nicardipine vs. sterile saline injection in reducing the index     measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to     the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a     1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to     PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and     adverse events will be collected by phone at 30 days and 1 year following the procedure.   "
7773|NCT03184142|"     Intimidation of medical students by health care professionals is a well-documented     phenomenon. Raising awareness of what constitutes intimidation is a preferred method for     preventing it through increased reporting. Simulation is a novel method of raising awareness     of intimidation.      This is a randomised controlled trial comparing the effectiveness of simulation (involving     actors), an educational video and no intervention, as adjuncts to group discussion, on     students' ability to identify and report intimidation. Medical students from the University     of Montreal in Montreal, Canada, will be recruited at the beginning of surgical clerkship.     They will complete a standardized and validated pre-intervention questionnaire on their     experience with intimidation consisting of multiple choice questions and short answers. They     will be randomised to one of the three interventions lasting 70 minutes that will be followed     by a 20-minute standardized discussion on intimidation with all students participating     together. At the end of their surgical rotation, they will complete a similar     post-intervention questionnaire with additional questions pertaining to the reporting of     intimidation.      Differences in intimidation reporting after the intervention as well as a before and after     comparison of the Negative Acts Questionnaire score will be studied.   "
7774|NCT03184129|"     To verify and assess the safety and efficacy of newly developed knee prosthesis (Wuhan     Yijiabao Biomaterial Co., Ltd.) in total knee arthroplasty.   "
7775|NCT03184116|"     This project will implement and evaluate a community-based intervention to improve individual     outcomes in violence-related injuries and homicide. Young African American men participating     in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be     randomized to receive an additional individual intervention based on the cognitive-behavioral     Reasoning and Rehabilitation program.   "
7776|NCT03184103|"     Acute post streptococcal glomerulonephritis is an immunologic response of the kidney to     infection, characterized by the sudden appearance of edema, hematuria, proteinuria and     hypertension . It is essentially a disease of childhood that accounts for approximately 90%     of renal disorders in children. The disease occurs especially in children between the ages of     2 and 12 years and young adults, and more often in male than in female .   "
7777|NCT03184090|"     This is an international, open-label, non-controlled, multicenter phase II clinical trial     with two different primary objectives: a biological and a clinical objective.      From a clinical point of view, the objective is to assess the clinical benefit of the     combination of palbociclib and hormonotherapy in patients with advance breast cancer that had     previously received endocrine therapy in combination with palbociclib and had achieved     clinical benefit during palbociclib treatment with subsequent disease progression.      From a biological point of view, the challenge is to define a molecular profile that allow     identifying patients that could benefit more from continuing on palbociclib after progression     on a prior palbociclib-containing regimen   "
7778|NCT03184077|"     To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to     monocryl using a validated sexual function questionnaire.      To assess maternal satisfaction with the laceration repair and suture material.      To assess overall perineal pain using a visual analog scale.      To assess the rate of wound breakdown and the need for suture removal.   "
7828|NCT03183414|"     To establish the correlation between echocardiographic parameters of the RV, measured with     TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the     perioperative process when RV dysfunction occurs.   "
7779|NCT03184064|"     Large postprandial glucose responses are associated with increased risk of chronic diseases,     including diabetes and cardiovascular disease. Our group have previously shown that fruit     polyphenol extracts, when consumed immediately before a mixed carbohydrate meal, reduce     postprandial glycaemia. The aim of this study is to investigate the effects of a blackcurrant     polyphenol extract and citrus polyphenol extract (and their combination), on postprandial     glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed     carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will     inhibit glycaemia compared to placebo, and a combination of the two will have a greater     effect.   "
7780|NCT03184051|"     This study investigates the potential of the ultrasound imaging technique to diagnose the     severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using     Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.   "
7781|NCT03184038|"     This phase II trial studies the neurological function in patients with multiple brain     metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy     (SBRT). Assessment of neurocognitive function may help show that SRS preserves neurological     function in patients with multiple brain metastases better than SBRT   "
7782|NCT03184025|"     The aim was to evaluate the clinical performance of HEMA-containing and HEMA-free all-in-one     self-etch adhesives with and without a surface sealing process with a nanohybrid composite in     occlusal caries restorations. The hypothesis is that the HEMA-containing and HEMA-free     all-in-one self-etch adhesive and the surface sealing process would significantly effect     clinical performance of occlusal restorations.   "
7783|NCT03184012|"     The hypothesis to be investigated is that no difference will be found upon comparing resin     composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in     restoring anterior primary teeth.   "
7784|NCT03183999|"     This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of     ginseng(GINST) supplementation for 12 weeks on sperm motility.   "
7785|NCT03183986|"     Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and     irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of     478 nm should be optimal in reducing total serum bilirubin. The aim of this study is     therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478     vs. 459 nm., respectively.   "
7786|NCT03183973|"     Sternal wound and there complication such as infection, Bruising and scar formation are known     as major complication cardiac surgery with a high mortality rate up to 50%. Several     approaches have been proposed for treatment of chronic sternal wounds in these patients.     however, Underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia,     atherosclerosis and malnutrition have main role against wound repairing. In this study     investigators aimed to treatment of patients with open heart surgery and need to strict     monitoring of sternal wound repair by Platelet Rich Fibrin.   "
7787|NCT03183960|"     Since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a     Danish region with 1.2 inhabitants have in cooperation with health professionals from a     specialized neurorehabilitation in a Danish municipality with 336,000 inhabitants, worked     through and is still working with an iterative process in the development of a novel     self-management support intervention for elderly stroke individuals.The intervention is going     to be implemented into the second phase- a randomized clinical controlled trial (RCT) in the     project named 'Stroke - 65 plus. Continued active life'.   "
7788|NCT03183947|"     The aim of the study is the examination of brain plasticity on on affective symptoms after     neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback. During the     fMRI neurofeedback training, patients with depression as well as patients with schizophrenia     are trained to consciously regulate the activity of areas which are associated with the     cognitive reappraisal of emotional stimuli.The aim is to improve the patients' subjective     emotional processing and perception in everyday life as well as to investigate the impact of     neurofeedback on resting-state networks in the brain. Healthy participants will be     investigated as control group.   "
7789|NCT03183934|"     This is an open-label follow up study to evaluate the safety for the subjects with     ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.   "
7790|NCT03183921|"     This is a multicentre, multinational, prospective observational investigation on ICU     critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU     Hospital-acquired Pneumonia (HAP), Non-ventilator ICU-acquired Pneumonia (NV ICUAP),     Ventilator associated pneumonia (VAP) Ventilator associated tracheobronchitis (VAT).   "
7791|NCT03183908|"     The overall aim of the study is to compare safety and immunogenicity of adjuvanted     inactivated influenza vaccine (IIV) (FLUAD) versus High-Dose inactivated influenza (Fluzone     High Dose) vaccine in ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded     clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons.     During each season, approximately 220 older adults will be enrolled at Duke University     Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects     will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza     vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then     return for a second blood draw without vaccination about 4 weeks later to assess for     influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6     months post-vaccination to assess for waning of influenza antibody titers. Subjects will     record the occurrence of local and systemic reactions (including fever, pain, tenderness,     swelling, redness, general systemic systems), unsolicited adverse events, medical care     utilization, and changes in medications over 8 days following vaccination. In addition,     serious adverse events and events of clinical interest will be assessed through 42 days     post-vaccination. Quality of life will be assessed 8 days post-vaccination and vaccine     perceptions surveys will be administered 8 days and 4 weeks post-vaccination.   "
7792|NCT03183882|"     We aim to determine if descriptive normative feedback of peer prescribing reduces opioid     analgesic prescribing by emergency medicine providers   "
7807|NCT03183687|"     This wellness initiative is aimed to assess the activity level, sleep habits and nutrition     status of resident physicians. The investigators will monitor for improvement in these areas     with initiation of an exercise program suited to the lifestyle needs of resident physicians.   "
7793|NCT03183869|"     The proposed randomized, open label, with treat as usual control group (standard treatment or     any disease modifying drugs), crossover phase II study will be conducted in 40 patients (n=20     per group) with the relapsing forms of multiple sclerosis according to the McDonald 2010     Criteria.      Patients will be randomized into 2 intervention groups. One will receive the FMT from     baseline and for the first 6 months (early intervention group). On the other hand, the other     group will be a control group during the first 6 months and will receive the FMT for the last     6 months of the study. Patients will be screened for eligibility based on MS diagnosis and     EDSS and if eligible then consented. All qualified patients will not be currently or recently     treated with high dose steroids.   "
7795|NCT03183843|"     The efficacy and safety of anticoagulation therapy using dabigatran in comparison with     warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic     replacement concomitant with Cox-Maze procedure.   "
7796|NCT03183830|"     This study evaluates the potential anti-inflammatory effects of inorganic dietary nitrate in     a model of acute inflammation relevant to cardiovascular disease (CVD).      Green leafy vegetables contain large amounts of inorganic nitrate, and research suggests that     this nitrate has beneficial effects on the heart and blood vessels. We have shown     anti-inflammatory benefits of inorganic nitrate in pre-clinical models of CVD, early     mechanistic studies in healthy volunteers, and in patients with hypertension,     hypercholesterolaemia and those suffering acute heart attacks that translate to     cardiovascular benefits. Understanding the mechanism of how this is achieved may open new     therapeutic options in CVD.      We therefore wish to explore whether inorganic nitrate might alter inflammatory responses     using a blister-model of acute skin inflammation. This study is a randomised control trial     with parallel limbs where half of patients receive nitrate-rich beetroot juice, and the other     half a nitrate-deplete placebo beetroot juice.   "
7797|NCT03183817|"     The goal of the research project PROTECT is to translate the person-centred care (PCC)     principles into an eHealth context. A developed PCC eHealth platform will be used as a tool     to identify patients´ resources to enhance coping and living with their chronic illness by     means of a dialog and partnership with staff and relatives. The PCC eHealth platform will not     replace, but instead be used as add on treatment to usual care (guideline directed care).   "
7798|NCT03183804|"     This is an open-label follow up study to evaluate the safety for the subjects with     ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.   "
7799|NCT03183791|"     The goal of this research is to assess the utility of smartphone-based progressive muscle     relaxation (PMR) for the treatment of headaches. While there are many commercially available     electronic diary and mind-body intervention apps for headache, there is little data showing     their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in     an earlier epilepsy study and beta tested with headache specialist and migraine patient     input. It also has functionality to track medications. This 2-arm randomized controlled study     will evaluate the feasibility and acceptability of RELAX for use with headache patients. One     arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual     care (MUC) group (this group receives standard of care and uses the electronic daily symptom     reporting diary). The goals are to assess the feasibility and adherence of the RELAX     intervention in persons with headache (Aim 1) and to gather data on the effects of the RELAX     intervention on headache disability (Aim 2).   "
7800|NCT03183778|"     The purpose of this proof-of-concept controlled-feeding study is to determine whether     patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum     potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a     plant-rich diet.   "
7801|NCT03183765|"     Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic     non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct     person-to-person contact or indirectly by fomites . Warts appear in various forms including     verruca vulgaris, plane, plantar, filiform, digitate and periungual.   "
7802|NCT03183752|"     It has been shown that insulin might be involved in the pathogenesis of thyroid growth.      Objective To evaluate the impact of IR and metformin use on the volume of benign thyroid     nodules (TNs).      Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle     aspiration confirming the diagnosis is necessary to inclusion. Patients will receive similar     tablets of MTF and placebo and instruct to take 3 tablets/day of MTF (500mg/tablet). Thyroid     volume, as TN volume, will be assess by ultrasound, both in the beginning, six months and one     year after randomization, by the same researcher blinded regarding location group. Blood     samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h     fasting.   "
7803|NCT03183739|"     The purpose of this study is to evaluate the safety and tolerability and evaluate     pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly     Japanese male and female subjects.   "
7804|NCT03183726|"     This is an open-label follow up study to evaluate the safety for the subjects with     ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.   "
7805|NCT03183713|"     This is a single-center prospective randomized investigation of patients undergoing surgical     arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy.     Patients indicated for surgery for cervical degenerative disease (CDD) will be screened for     yellow flags using validated tools to assess pain. Cognitive-behavioral therapy (CBT) will be     used to modify yellow flags in spine patients. All patients at risk will be stratified by     risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). The goal     of this study is to unmask the relationship between psychological distress and clinical     outcomes in patients undergoing surgical treatment for cervical degenerative disease     resulting in combinations of neck pain and radiculopathy, and to determine the effectiveness     of a brief psychological intervention on subset of patients who screen positive for     psychological distress prior to their surgeries.   "
7808|NCT03183674|"     Observe effects of oxytocin on individuals with autism spectrum disorder   "
7874|NCT03182803|"     This is a single-arm, open-label, one center clinical study, to determine the safety and     efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies     (CTLA-4 and PD-1) and chimeric antigen receptor targeting mesothelin (mesoCAR-T) in adult     patients with mesothelin positive, advanced recurrent or refractory malignant solid tumors.   "
7815|NCT03183583|"     Prolonged wound drainage after total hip or knee arthroplasty is a very undesirable     complication, both from medical as patients view. Wound drainage prolongs hospital admission     and is associated with an increased risk of infection (1) post-operative wound drainage of     more than 48 hours is associated with an increased infection risk of 42 percent a day in hip     arthroplasty and 27 percent a day in knee arthroplasty. (2) Patient organizations report that     wound drainage is considered as one of the most undesirable complications.      In our hospital, patients undergoing hip or knee arthroplasty are treated according to a     fast track protocol, in most cases resulting in a hospital admission of only two days. This     increases the chance that patient's release from hospital will be delayed due to wound     drainage. The fact that our department recently started to perform hip and knee arthroplasty     in a daycare setting increases this chance substantially.      In hemiarthroplasty of the knee, tissue adhesive was used in addition to conventional wound     closure techniques with monocryl sutures. Resorbable monocryl sutures were used so that the     usual visit to our outpatient department to remove the sutures was no longer necessary.     However, we experienced an increase in wound drainage and complications using only monocryl.     The addition of a tissue adhesive decreased the post-operative wound complication     drastically. This in mind, we started to use tissue adhesive in regular hip and knee     arthroplasty as well. With tissue adhesive in addition to conventional staples, we noticed     good results. These results however, were subjective and not officially recorded.      In a previous study, good results are reported in decreasing wound drainage with the use of a     tissue adhesive in addition to staples. Clinical relevance was not reported and the study     design lacked a cost-effectiveness analysis (3) The increase in cost for the use of the     tissue adhesive involved was noted by our board of directors. Because lack of a clear medical     of financial benefit, we were asked to minimize the use of tissue adhesive, resulting in     usage of tissue adhesive solely in a day care setting, which comprises only 5 to 10 percent     of our treated population. Previous study reported a decrease in post-operative wound     drainage when tissue adhesive was used in addition to staples in knee arthroplasty. However,     no financial benefit is known, therefore this treatment has not been accepted into daily     practice. In our department, prolonged hospital admission due to wound drainage is not found     to be uncommon. Our hypothesis is that the addition of tissue adhesive in wound closure after     hip and knee arthroplasty will significantly decrease post-operative wound drainage, leading     to a reduced number of admission days. In addition, we expect less patients to return to our     outpatient clinic for non-regular visits due to wound complications. Expensive bandages are     used in our standard treatment protocol. Less wound drainage would mean less bandages. All     these things combined will lead to a reduction in overall health care costs   "
7816|NCT03183570|"     The investigators wish to evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in     patients with Idiopathic Pulmonary Fibrosis.   "
7817|NCT03183557|"     There has been no comparative data between Zoledronic acid and Zoledronic acid combined with     active vitamin D in primary and secondary osteoporosis.   "
7818|NCT03183544|"     Prostate cancer is the most common cancer in men. Early detection of primary diseases and     recurrence is crucial for patient counseling and management. Conventional imaging modalities     (CT-MRI) are limited to detect recurrence.      Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and     in patients with suspicious recurrent disease.      Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher     diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The     most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier,     ANMI, has developed a kit formulation of PSMA-11 which will be test in this clinical trial.   "
7819|NCT03183531|"     The objective of present study was to evaluate clinical and laboratory characteristics of     febrile neonate and describe the incidence of SBI in febrile neonates. Secondarly     investigators aimed to test usefulness of major protocols and new protocol in evaluating only     febrile neonate.   "
7820|NCT03183518|"     To evaluate the skin irritation and sensitization potential of a cosmetic facial product,     under exaggerated conditions of use with controlled product application and under supervision     of a dermatologist.   "
7821|NCT03183505|"     The purpose of this study is to evaluate the safety and efficacy of Anyu Peibo Capsule     comparing with placebo in the treatment of Chinese Patients with Depression. And to provide     some scientific evidence for protocol designing in following phase Ⅲ clinical trial.   "
7822|NCT03183492|"     This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A     vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating     antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult     vaccine. In the present study, the anamnestic response will be assessed 30 days after the     challenge dose.   "
7823|NCT03183479|"     Allogeneic blood products transfusions are often necessary to treat perioperative bleeding in     patients undergoing complex scoliosis surgeries. A prospective, randomized trial is designed     to evaluate if the infusion of fibrinogen concentrate may reduce allogeneic blood transfusion     in patients undergoing scoliosis surgery. Eligible patients will be randomly assigned to     treatment group (fibrinogen concentrate infusion) and control group (normal saline infusion),     and functional fibrinogen will be measured to guide the infusion of fibrinogen concentrate.     Perioperative blood loss, intraoperative blood loss, and the amount of perioperative     allogeneic blood transfusion will be compared between the two groups to determine the effect     of fibrinogen concentrate infusion.   "
7824|NCT03183466|"     The purpose of this study was to randomly classify the upper third of the subscapularis in     1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement     group) and the difference between clinical and clinical scores.   "
7825|NCT03183453|"     Confabulators consistently generate false memories without intention to deceive and with     great feeling of rightness. However, there is currently no known effective treatment for     them. In order to fill this gap, we performed a neuropsychological treatment in two groups of     confabulators: experimental vs. control (ClinicalTrials.gov ID: NCT02540772).      Now, we intend to replicate the treatment with a larger sample of confabulators and with     other two control groups: non-confabulator patients with brain injury and healthy individuals   "
7826|NCT03183440|"     Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic     Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases     (prevalence 20%). Recent studies have shown that allergies were associated with a disruption     of the gut microbial 'balance' suggesting that the use of nutritional intervention very early     in life may restore an optimal pattern of microflora aiming at improving the host's health.     So far, most human intervention studies have mainly focused on improving postnatal infant     colonization. Our study will test the hypothesis that a maternal antenatal prebiotics     (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk     children.   "
7827|NCT03183427|"     This study aims to determine size of corpus callosum on midsagittal MR scan in patients with     a pineal cyst and to compare it with the control group without a pineal cyst.   "
7839|NCT03183271|"     The aim of this research project is to test the local response and the acute toxicity (which     can be observed within 90 days).   "
7895|NCT03182517|"     Secondary hyperparathyroidism is an important complication in patient with chronic kidney     disease . It is associated with bone complication and an increase in cardiovascular mortality     The parathyroid hormone rises in these patients as consequence of low concentration of     vitamin D3 ,reduction in quantities of serum calcium, phosphorus retention and reduction of     vitamin D receptors sensitive to calcium.   "
7829|NCT03183401|"     The DENACAPST programme represents an important initiative to provide near nation-wide     roll-out of an important cancer surveillance program for childhood cancer survivors. The     program is based on internationally recognized standards in cancer surveillance, which were     developed by the International Guideline Harmonization Group (IGHG) with support of all     relevant stakeholders in cancer survivorship research and clinical work in Europe, Canada and     the United States and recognized French recommendations about breast screening for women at     high risk of cancer.      With this programme, French centers organized themselves to provide to childhood cancer     survivors adequate medical attention, which includes close medical surveillance for     breast/thyroid cancer where appropriate, based on adequate risk stratification.      The aim of the study is to analyze if the recommendations about breast and thyroid cancer     screening are followed in this population and secondly to provide more informations about     these second cancers and about the screening.   "
7830|NCT03183388|"     New treatments to help to reduce the emotional dysregulation of mood disorders are critically     needed. This is a study of an emotional dysregulation psychotherapy treatment in which     subjects will learn skills to help to down-regulate maladaptive emotional responses and learn     beneficial, healthy habits. Investigators will perform symptom and behavioral assessments and     scanning prior to the treatment and will then repeat scanning, symptom and behavioral     assessments at the midpoint, and after the psychotherapy is completed. This collected     information will assess whether the treatment can improve functioning of emotion regulation     brain circuitry.   "
7831|NCT03183375|"     Objectives      Primary objectives:        -  To determine the efficacy of Hydroxyurea in the study participants.        -  Hypothesis: The study will result in either maintenance or rise in hemoglobin as          compared to the control treatment.      Secondary objectives:        -  To determine the compliance of Hydroxyurea in study participants.        -  To determine the safety of Hydroxyurea in the study participants. Design and Outcomes      An open label randomized controlled trial to test the efficacy and safety of Hydroxyurea on     beta thalassemia major patients. It is a six months study. Findings of physical examination,     vital sign variables, laboratory variables and ultrasound at baseline, during and end of the     study will be listed. Schedule of intervention is mentioned in section 6.1. later in the     protocol.      Interventions and Duration Hydroxyurea will be given to the participants in intervention arm     along with the standard treatment if thalassemia (blood transfusion and iron chelation     therapy) and the control arm will receive the standard treatment (blood transfusion and iron     chelation therapy) only. Each participant will be followed up for 6 months after initiating     the intervention. Intervention will be given for 6 months or until the participant withdraws     from the study or due to any reason, the investigator stops the intervention.      Sample Size and Population This pilot study will be done on 100 patients initially.     Stratified randomization will be done on the basis of presence of Xmn polymorphism. And the     study population will be assigned to intervention or control arm randomly through a computer     software (randomizer.org).   "
7832|NCT03183362|"     The aim of this randomized controlled trial is to determine whether the use of barbed sutures     to close uterine incision at cesarean section is associated with more postoperative adhesions     compared with conventional sutures or not.   "
7833|NCT03183349|"     20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided     into two groups. the selected teeth will be extracted and immeiate implants will be placed in     all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the     buccal space between the implant and the bone, the second group will recieve platlet rich     fibrin to fill the buccal space between the implant and the bone   "
7834|NCT03183336|"     20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected     and randomly divided two groups (10 in each group). the first group received interpositional     block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane.     the second group received onlay block grafts (harvested from the chin and ramus) and covered     with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge     width dimensions is then measured using radiographic analysis using cone-beam computed     tomography scans   "
7835|NCT03183323|"     ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure     population. The goal is to evaluate if a home-based telerehabilitation project can increase     physical activity in heart failure patients. Patient will be provided telerehabiliation or     advice on physical activity (standard care).   "
7836|NCT03183310|"     The effect of chlorpromazine (Largactil) on esophageal sensitivity will be investigated in     this study. Overnight fasted subjects will be asked to fill out 2 questionnaires to assess     the emotional status before their onset of the stimulation tests. The multimodal stimulation     probe will be positioned through the mouth in the distal esophagus.      After the ingestion of the stimulation probe, 10mg of chlorpromazine or placebo (saline) will     be slowly administered via intravenous injection. Hereafter the multimodal stimulation tests     will be initiated.      Esophageal sensitivity will be assessed by performing thermal, mechanical, electrical and     chemical stimulation of the esophagus. The chlorpromazine condition will be compared with a     placebo condition, this will be organised on 2 separate study visits in a randomised order.   "
7837|NCT03183297|"     This will be a double-blind, placebo-controlled study with a 4-way crossover design with     subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on     different study days, in conjunction with a quantity of alcohol estimated to be sufficient to     produce a hangover the next day. The primary objective of the study is the evaluate the     pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001     administered in conjunction with alcohol to healthy adult subjects.   "
7838|NCT03183284|"     Immune thrombocytopenic purpra(ITP) is an autoimmune thrombocytopenic syndrome characterized     by decreased platelet count and increased risk of bleeding, primarily due to immunoglobulins     G(IgG)autoantibodies opsonizing the individual's platelets,resulting in markedly enhanced Fc     receptors(FcR)-mediated phagocytosis and destruction by macrophages in the     reticuloendothelial system within spleen Severe ITP defined as :Patients who have clinically     relevant bleeding that mean that patients have bleeding symptoms at presentation sufficient     to mandate treatment,or occurrence of new bleeding symptoms requiring additional therapeutic     intervention with a different platelet-enhancing agent or an increased dose.   "
7840|NCT03183258|"     This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps     for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate     the use of sentinel skin flaps in clinical practice and assess whether rejection occurs     concordantly or discordantly between the skin flap and the transplanted abdominal organs. If     successful, sentinel skin may allow improved immune surveillance and thereby facilitate     earlier treatment of rejection with subsequent improvements in allograft survival and patient     morbidity.   "
7841|NCT03183245|"     The main purpose of this study is to compare the Human Acellular Vessel (HAV) with     arteriovenous fistula (AVF) when used for hemodialysis access   "
7842|NCT03183232|"     In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing     surgery, for example, cryosurgery going to be investigated   "
7843|NCT03183219|"     In this study, effects of γδT cells on human Liver Cancer in combination with tumor reducing     surgery, for example, cryosurgery going to be investigated.   "
7844|NCT03183206|"     In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing     surgery, for example, cryosurgery going to be investigated.   "
7845|NCT03183193|"     Non-alcoholic fatty liver disease (NAFLD) is a condition of excessive hepatic lipid     accumulation in subjects that consume less than 20g ethanol per day, without other known     causes as drugs consumption or toxins exposure. In Western countries, the rate of this     disease lies about 30% in the general adult population. The process of developing NAFLD can     start from simple steatosis to non-alcoholic steatohepatitis (NASH), which eventually can     lead to cirrhosis and hepatocellular carcinoma in the absence of alcohol abuse. Liver biopsy     is considered the gold standard of steatosis, fibrosis and cirrhosis. However, it is rarely     performed because it is an invasive procedure and investigators are focusing in the     application of non-invasive liver damage scores for diagnosis.      The pathogenesis of NAFLD is multifactorial and triggered by environmental factors such as     unbalanced diets and overnutrition as well as by lack of physical activity in the context of     a genetic predisposition. Nowadays, the treatment of NAFLD is based on diet and lifestyle     modifications. Weight loss, exercise and healthy eating habits are the main tools to fight     NAFLD. Nevertheless, there is no a well characterized dietary pattern and further studies are     necessary.      With this background, the general aim of this project is to increase the knowledge on the     influence of nutritional/lifestyle interventions in obese patients with NAFLD, as well as     contribute to identify non-invasive biomarkers/scores to early diagnosis of this pathology in     future obese people.   "
7846|NCT03183180|"     According to American Heart Association criteria, patients who have had Rheumatic Fever (RF)     should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in     patients with well-documented histories of RF and in those with evidence of rheumatic heart     disease.      There is a limited data regarding adherence of patients to treatment and efficacy of     treatment.      In this study, patients with RF who are older than 21 years will be collected from a     computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health     Funds. Patients will be assigned to the study after obtaining informed consent.      Previous adherence to antibiotic prophylaxis will be examined according to computerized     database of drugs which were issued to the patient since RF diagnosis.      Past history of cardiac involvement, including past Echocardiograms, will be collected from     computerized database. In addition, the current cardiac state will be assessed by an     experienced cardiologist, including a full new Echocardiogram examination.   "
7847|NCT03183167|"     Intracerebral hemorrhage [ICH] is the most feared sub-type of stroke, associated with a high     mortality rate up to 50% and thus leaving large proportions of patients in functionally     dependent states. In recent years randomized trials have failed to provide an effective     intervention to improve functional outcome in ICH. Therefore, evidence regarding acute     therapeutic interventions as well as secondary treatment approaches is still limited.      The present monocentric longitudinal study on spontaneous ICH patients is based on a     prospective institutional stroke registry including all hemorrhagic stroke patients treated     at a German University Hospital, Department of Neurology, over a 10 year time frame     (2006-2015). The main aim of this investigation, besides analyses of epidemiological aspects,     will be (i) to identify possible treatment targets influencing functional outcome, and (ii)     to evaluate existing therapeutic strategies in ICH care.   "
7848|NCT03183154|"     The objective of this study is to explore the impact of initiation of ART with different     regimens in naïve MSM (in the setting of acute and chronic HIV-infection) on the probability     of transmission of HIV by mathematical modeling.   "
7849|NCT03183141|"     Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug     will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The     purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of     Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after     receipt of SER-109 or Placebo in Study SERES-012.   "
7850|NCT03183128|"     Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days     in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group     II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to     reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.   "
7861|NCT03182985|"     The investigators intend to measure the health impact of a dietary intervention known as time     restricted feeding (TRF) on patients with body mass index ≥ 28 and metabolic syndrome (three     or more of: increased waist circumference, abnormal cholesterol levels, elevated blood     pressure, or elevated blood sugar). The investigators will enroll patients with metabolic     syndrome who eat for ≥ 14 hours per day and will ask participants to reduce daily oral intake     to 10 hours per day. The investigators will assess the impact of this dietary change using     measures obtained before and after a 12 week intervention period, including body mass index,     blood pressure, various lab parameters and blood sugar levels (assessed using a continuous     glucose monitor). The investigators will assess for compliance with TRF using a Smart Phone     application (myCircadianClock (mCC) app).   "
7862|NCT03182972|"     This study will assess the current practice of medication reconciliation among pharmacists in     the selected institutions with a view to making an intervention to address gaps discovered   "
7851|NCT03183115|"     Esophageal cancer is a highly lethal disease, and its incidence is still increasing in the     world. Recent advances in image-enhanced techniques such as Lugol chromoendoscopy and narrow     band imaging, the number of patients with early esophageal squamous cell neoplasias (ESCNs)     detected has markedly increased. Endoscopic submucosal dissection (ESD) enables en bloc     resection of the neoplasia, and the resected specimen allows for a pathological assessment to     evaluate the curability. However, the patients who received complete ESD for early ESCNs     frequently developed metachronous recurrence. The cumulative metachronous recurrence rate at     5 years was 50%, and the mean annual incidence of newly diagnosed metachronous tumors was     10%. Among them, those with speckled lugol staining pattern over the esophageal background     mucosa have the highest risk and should be seen as a precancerous lesion of ESCCs. This issue     is gaining attention in the era of endoscopic treatment, but currently there was no     appropriate strategy to prevent the tumor recurrence in these high-risk subjects.      Endoscopic radiofrequency ablation (RFA) is a rapidly evolving therapeutic modality, and     recent studies have shown its efficacy and safety for eradicating for flat type early ESCNs.     To search a best strategy for the prevention of ESCNs, the investigators thus propose a     hypothesis that the preemptive RFA for esophageal speckled lugol background mucosa may     prevent the metachronous neoplastic recurrence after complete endoscopic resection.   "
7852|NCT03183102|"     The purpose of this pilot study is to determine if suppressing estrogen in premenopausal     women results in changes in gut microbiota and if dietary flaxseed modulates these changes.   "
7853|NCT03183089|"     The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to     Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.   "
7854|NCT03183076|"     The Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy,     There is a high prevalence worldwide , especially in Latin American countries, including     Mexico.      Low income earners, many of which do not have a social security, must meet the high costs by     Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination     therapy, because monotherapy is insufficient .      The diet adkins makes some changes in the traditional food habits by others that are     accessible and not necessarily expensive, whose mechanism allows for better control of the     seizures.   "
7855|NCT03183063|"     Deep vein thrombosis (DVT) occurs when a blood clot forms in a deep vein, typically in the     lower extremities. Pulmonary embolism (PE) occurs when a DVT clot (or fragment) breaks free     and travels through the heart to the pulmonary arteries (having to do with the lungs) and     lodges in an artery causing a partial or complete blockage. PE is difficult to diagnose due     to the non-specific signs and symptoms patients have with this condition such as a cough,     shortness of breath, increased heart rate, blood tinged sputum, low oxygen levels.      The standard test to diagnose PE is the Pulmonary Computed Tomography Angiogram (CTA). This     can be prohibitive with some patients due to the amount of radiation exposure as well as the     complications associated with the need to use intravenous (IV) contrast. In patients not     eligible for CTA, the other option for diagnosis is a ventilation-perfusion (V/Q) single     photon emission computed tomography (SPECT) scan. Though this is often prohibitive due to     transport to Nuclear Medicine dept., prolonged test time, no test during off hours, etc. In     this study the investigators are looking at an alternative method of diagnosing PE's in the     Emergency Department where the investigators look at the breathing and blood flow to the     lungs thru respiratory gated non-contrast CT (commonly called 4DCT).      The investigators hypothesize that respiratory induced blood mass change in the lungs will     allow the identification of under-perfused lung regions. The investigators did a prelimary     study and tested this theory in cases with low oxygen levels, narrowing of the blood vessels,     airway obstruction, comparing 4DCT with SPECT scan. The images compared well. It is unknown,     however, if this process works to detect perfusion defects due to PE where the perfusion is     obstructed and breathing normal.      15 participants will be enrolled with a diagnosis of PE by CTA. Each will receive SPECT/CT     and 4DCT imaging on the same day. Respiratory induced blood mass change images will be issued     from the 4DCT and compared to the SPECT/CT images.   "
7856|NCT03183050|"     Clinical guidelines for women with early stage breast cancer integrate genomic tumor     profiling tests such as the Oncotype DX Recurrence Score to refine recurrence estimates and     systemic therapy selection when combined with existing markers. Guidelines suggest that the     25% with a high Score benefit from chemotherapy and the 50% with a low Score can safely avoid     chemotherapy. Many challenges remain to maximize the benefits of testing prior to release of     trial results in the next year. Strong clinical communication can impact proximal outcomes of     patient comprehension, treatment preferences and satisfaction, involvement in care decisions     as well as longer-term outcomes of treatment adherence and QOL. These proximal outcomes can     be influenced by patient activation interventions utilizing a question prompt list (QPL). In     the context of patients receiving Oncotype DX testing, the QPL could allow them to better     understand the rationale for their oncologist's treatment recommendation, what it means for     managing their disease, and encourage alignment of treatment preferences and selection with     the Recurrence Score. Research is conducted in two phases to test the feasibility and impact     of the QPL. In Phase 1, the draft QPL will be revised based on in-depth interviews with     patients (N=20) and medical oncologists (N=10). Phase 2 will be a single-arm trial (N=75) to     demonstrate feasibility and preliminarily assess the impact of the QPL on key outcomes.   "
7857|NCT03183037|"     The purpose of this study is to compare the effects of real acupuncture with placebo     acupuncture or usual care on symptoms of nerve damage from chemotherapy.   "
7858|NCT03183024|"     Study to determine the efficacy of benralizumab when compared to placebo in patients with     chronic hives that do not respond to antihistamine treatment   "
7859|NCT03183011|"     This study is evaluating how MRI after CRT can provide key insights regarding LV function,     structure, and mechanics resulting from CRT in patients with or without LV scar and inform     optimal pacing strategies. The expected accurate and reproducible response assessment with     cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and     the insights from the post-CRT MRI promise to improve implementation of CRT.   "
7860|NCT03182998|"     This randomized phase III trial studies how well decision aids work in improving knowledge in     patients with prostate cancer. Decision aids may improve patients' knowledge of their     condition and options for treatment, and may also help when talking with their doctor.   "
7873|NCT03182816|"     This is a single-arm, open-label, one center clinical study, to determine the safety and     efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies     (CTLA-4 and PD-1) and chimeric antigen receptor targeting epidermal growth factor receptor     (EGFR-CAR) in adult patients with EGFR positive, advanced recurrent or refractory malignant     solid tumors.   "
15286|NCT03085381|"     To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus     (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects     aged 9-45 years.   "
7863|NCT03182959|"     This study is being done to see whether Avmacol®, a dietary supplement made from broccoli     sprout and seed extract powder, induces changes in inner cheek cells that may be protective     against environmental toxins such as tobacco.      There are three main goals of the study:        1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair          damage from environmental toxins;        2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the          participant's urine and blood;        3. to learn whether the immune system can be stimulated by Avmacol®, by studying the          natural killer cells and T cells in the participant's blood.   "
7864|NCT03182946|"     This study evaluates the impact of platelet transfusion on geriatric patients with platelet     dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover     better if their platelet dysfunction is corrected with platelet transfusion.   "
7865|NCT03182933|"     Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on     physical therapy measures and pain scores as well as opiate consumption.   "
7866|NCT03182920|"     The purpose of this study is to look at the amount of study drug that gets into the blood     stream and how long it takes the body to get rid of it by comparing the results of healthy     elderly participants to those of healthy young participants. The tolerability of the study     drug will be evaluated. Information about any side effects that may occur will also be     collected.      This study will last up to approximately 19 days, not including screening. This study     requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four     days/three nights. Participants will return for a follow-up seven days after last dose of     study drug. Screening is required within 28 days prior to Day 1.      This study is for research purposes only and is not intended to treat any medical condition.   "
7867|NCT03182907|"     The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and     tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed     diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug     treatment. The primary hypothesis is that the area under the concentration-time curve from 0     to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with     bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of     adults with bezlotoxumab,   "
7868|NCT03182894|"     Trial Design This is an open label, single-arm, phase IB/II trial to evaluate the safety,     tolerability and anti-tumor efficacy of epacadostat (INCB024360) in combination with     pembrolizumab (MK-3475) plus azacitidine in patients with chemo-refractory MSS mCRC.      The phase 1B portion of the study will evaluate the safety, tolerability and RP2D of     epacadostat (INCB024360) in combination with pembrolizumab plus azacitidine in subjects with     chemo-refractory MSS mCRC without any further standard treatment options.      The phase 2 portion of the study will evaluate the efficacy and safety of epacadostat     (INCB024360) in combination with pembrolizumab plus azacitidine in subjects with     chemo-refractory MSS mCRC without any further standard treatment options.      In both phase IB and phase 2 portions, patients will receive the combination of azacitidine,     pembrolizumab and epacadostat (INCB024360) for the first 18 cycles (Cycles 1-18). Beginning     with Cycle 19 through Cycle 35, patients will receive the combination of pembrolizumab and     epacadostat (INCB024360).   "
7869|NCT03182881|"     Objective. To compare the effectiveness of myofascial therapy against manual lymphatic     drainage in the reduction of sequelae secondary to conservative surgery and radiotherapy in     women who survived breast cancer.      Design. Randomized clinical trial. Site. Faculty of Physiotherapy of the University of     Valencia. Participants. Twenty-four patients were included in the study. Interventions. 13     patients were randomly assigned to treatment with myofascial therapy and 11 to receive manual     lymphatic drainage.      Main measurements. Pain measured using the Visual Analogue Scale, shoulder joint range,     shoulder functionality using the DASH questionnaire, quality of life assessed using the     FACT-B questionnaire, and the depressed status of the patients using the PHQ-9 . All of this     was assessed before and after treatment, and one month later as follow-up.   "
7870|NCT03182855|"     This randomized, controlled trial compares the anti-thrombotic effect of cangrelor and     ticagrelor on platelet activity in patients with acute ST-elevation myocardial infarction.      Patients will receive either prehospital ticagrelor (180 mg - crushed) or in-hospital     cangrelor (bolus 30 μg/kg within 1 minute followed by infusion (4 μg/kg/minute) for two     hours) followed by 180 mg ticagrelor.      The primary study end-point is platelet reactivity at sheath insertion, at the end of the PCI     procedure (before sheath removal) and two hours after PCI is initiated. The secondary     end-point is the proportion of patients with inappropriate or harmful P2Y12 administration.   "
7871|NCT03182842|"     A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects     with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in     glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle     Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California,     USA) versus Self-Monitoring Blood Glucose (SMBG - control).      Study duration will be two weeks per subject and two weeks overall, it will take place at     youth summer camp for children with T1D. Main inclusion criteria include age of six to 15     (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months     of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other     chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current     medications (other than insulin) (detailed list of inclusion and exclusion criteria list can     be found at section 6).      The objectives of this clinical investigation is:      1. to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with     T1D during two weeks of summer camp.   "
7872|NCT03182829|"     This trial is conducted to assess the performance and handling of the in vitro diagnostic     (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients     on treatment with direct oral anticoagulants Apixaban, Edoxaban, Rivaroxaban, and Dabigatran     (DOAC) in an actual point-of-care (POCT) setting in comparison to results obtained by liquid     chromatography tandem mass spectrometry (LC-MS/MS) from urine samples.      This trial is conducted to assess the performance and handling of the IVD for oral direct     factor Xa and thrombin inhibitors from urine samples of patients on treatment with DOACs in     an actual point-of-care setting in comparison to results obtained by liquid chromatography     tandem mass spectrometry (LC-MS/MS) from urine samples.   "
7875|NCT03182790|"     The present study will examine (1) the effectiveness of regular messages and     semi-personalized instant messaging with AWARD brief advice and active referral to smoking     cessation (SC) services and (2) explore the use of CBPR model to build capacity and to engage     community partners in taking on this important public health issue for sustainability in the     community. In addition, a process evaluation will be conducted to assess the effectiveness of     the recruitment activity and how it is linked with the overall program outcomes.   "
7876|NCT03182777|"     Patients with cardiac channelopathies needing restorative dental treatment will be included     in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine     and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL)     will be evaluated. The patients will be their own control and will be assessed by Holter     monitoring for 28 hours, blood pressure measurement and anxiety measuring.   "
7877|NCT03182764|"     Aim: to collect further information on issues related to tobacco control which should be     addressed and advocated in further tobacco control measures in Hong Kong      The objectives of this policy-related survey are as follows:        1. to update information on trends and prevalence of secondhand smoke, smoking attributable          health effects, cessation services, and e-cigarette;        2. to investigate the level of public support on current and future tobacco control          measures and taxation;        3. to address the timely impacts of smoke-free policies, public support for further tobacco          control measures and assist COSH in shaping policy direction for government.      Current study is a cross-sectional retrospective telephone survey based on questionnaires. In     total, 5,104 subjects will be randomly selected for a telephone interview. The subjects will     be categorized into three groups, i.e. never smokers (1,700), ex-smokers (1,700) and current     smokers (1,704). They will be required to answer a questionnaire via telephone. All data     shall be collected using a Computer Assisted Telephone Interview (CATI) system, which allows     real-time data capture and consolidation. All interviews shall be conducted anonymously.     Analysis of survey data will aim to identify current opinion on tobacco control policies and     implications for future policies. Analyses will be controlled for confounding variables as     required by stratification into sub-groups based on important pre-defined characteristics     and/or by multivariate analysis. Comparison with past trends and, where possible,     extrapolation of future trends will be explored. Weights will be applied to adjust for the     sex and age of Hong Kong population, and to handle the over-sampling issues of current     smokers. The data analysis will be conducted by statisticians.   "
7879|NCT03182738|"     The purpose of this study is to use technology to improve symptom status and ultimately     improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose     of the intervention (VIP-HANA) is to improve symptom status. The investigators hypothesize     that VIP-HANA will improve symptom frequency and intensity.   "
7880|NCT03182725|"     Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans,     but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating     tachycardia upon postural changes such as standing that impairs their quality of life.     Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS     patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120     beats/min within the first ten minutes of a diagnostic tilt table test without postural     hypotension. There are currently no effective treatment methods for POTS. However, several     studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine     specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the     heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart     failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has     been also used for treatment of inappropriate sinus tachycardia with good benefit. The     hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve     functional status in patients with POTS.   "
7881|NCT03182712|"     The aim of this study was to verify the effect of a combined supplementation [n-3 PUFA (known     to induce anti-inflammatory effects) plus vitamin E (known for its antioxidant properties)]     on lipidic, glycemic, redox status and inflammatory parameters in type 2 diabetic patients.     In addition, considering that exercise, at high intensities, can induce a transient     inflammatory state and increase oxidative stress (OS) markers, the investigators tested if     our nutritional intervention could attenuate this response within this population (thus,     using high intensity exercise as inductor of acute inflammatory/OS state).   "
7892|NCT03182556|"     Some authors claim that patients with musculoskeletal pain tend to underestimate their levels     of muscle tension. The results of studies find evidences of the deficits in the perception of     muscular tension in patients with chronic pain, being this the pathogenic factor in some     musculoskeletal alterations. These studies show that patients with chronic pain can not     identify their muscle tension and suggest that this contributes to maintaining pain. Thus,     positive results have been found with relaxation and electromyographic biofeedback in     patients with chronic pain. If these symptoms are due to excessive stress, patients should be     able to benefit from regulation of muscle activity through BFB-EMG, thus learning to regulate     the physiological variable. The study will be carried out in the electrotherapy laboratory of     the Health Sciences Building of the University of Almeria. Initially, the sample will be     chosen and the informed consent of the subjects will be obtained. Before the start of     treatment, a baseline assessment of the dependent variables will be performed. Subsequently     subjects will undergo three sessions of manipulative therapy over 12 weeks (one session per     week). After the therapeutic intervention, a new determination of the dependent variables     will be performed.   "
7893|NCT03182543|"     The aim of this study is to assess the antioxidant capacity of two mango base beverages (AM1,     AM2), against exercise-induced oxidative stress.   "
7896|NCT03182504|"     The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in     healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being     developed as a combination therapy with the beta-lactam meropenem for the treatment of     serious gram-negative bacterial infections. Adult male and female healthy participants will     receive a single intravenous infusion of nacubactam co-administered with meropenem and then     undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid     (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.   "
7882|NCT03182699|"     Background:      Calcimimetic therapy has been shown to reduce systemic FGF23 levels, which themselves are     associated with left ventricular hypertrophy (LVH) in chronic kidney disease (CKD).      Methods/design:      This is a randomized multicenter trial in which the effect of etelcalcetide in comparison to     alfacalcidol on LVH and cardiac fibrosis in hemodialysis patients with secondary     hyperparathyroidism (sHPT) will be investigated.      The investigators will perform a comparative trial testing etelcalcetide vs. alfacalcidol     treatment on top of conventional HPT therapy for 12 months. A total of 62 hemodialysis     patients with sHPT and LVH will be enrolled in the study. After a washout of all calcimimetic     and vitamin D treatment, subjects will be randomized at 1:1 ratio to either etelcalcetide or     alfacalcidol. The participants will undergo cardiac imaging consisting of cardiac resonance     imaging (cMRI) and strain echocardiography before and at baseline and one year. Etelcalcetide     or alfacalcidol will be administered intravenously three times per week following chronic     hemodialysis treatment.      The primary end point will be a change in left ventricular mass index (LVMI) measured in     g/m2. As secondary end points the changes in left atrial diameter (LAD), cardiac fibrosis,     wall motion abnormalities and left ventricular function, changes in serum FGF 23 and soluble     Klotho levels as well as changes in proBNP as well as pre- and postdialysis troponin T (TnT)     levels will be determined. Additionally a quantitative analysis of the treatment influence on     the individual metabolites of the renin-angiotensin-aldosterone system (RAAS) will be     performed using mass spectrometry (RAAS fingerprint).   "
7883|NCT03182686|"     This is a phase 3 randomized study is to confirm the efficacy of an intra-articular injection     of Ampion™ in adults with pain due to severe osteoarthritis of the knee.      There will be a 7-day screening period for each subject followed by a 12-week participation     period.      The primary trial objective is to evaluate the clinical efficacy of Ampion using the     OMERACT-OARSI criteria D and percent change from baseline (using the WOMAC 3.1 Index and PGA     as assessments).      The secondary trial objectives are to evaluate the safety of a single intra-articular     injection (4 mL) of Ampion.   "
7884|NCT03182673|"     This aim of study to assess the safety and tolerability of SHR7390 combined with SHR-1210 and     to define Dose limiting toxicity（DLT）and the maximum tolerated dose (MTD) of SHR7390 in the     patients with advanced solid tumors.      To evaluate the pharmacokinetics of SHR7390 in patients with advanced solid tumor.To assess     the antitumor activity of SHR7390 combined with SHR-1210 in patients with advanced solid     tumors preliminarily and recommend reasonable dosage regimen of SHR7390 for the follow-up     clinical trial.   "
7885|NCT03182647|"     Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee     injuries. Because it is such a significant injury - requiring a long period of rehabilitation     before the injured person is ready to return to physical activity, the burden of injury is     high. This can help to explain why so much of orthopaedic research is devoted to evaluating     the outcomes of ACL injury. However, while there has been extensive study of short-term (up     to 5 years after injury) outcomes, few studies have followed patients beyond 15 years after     their ACL injury. This is important because long-term follow-up can provide key insights to     guide the information provided to newly injured patients (e.g. to help set realistic     expectations of what the injured person can expect of their knee function in the future), and     help us evaluate the efficacy of previous treatments.      The primary aim is to assess the influence of an acute ACL injury on knee function and     quality of life, 32-37 years after the index injury. Approximately 300 patients injured     between 1980 and 1985 will be invited to participate in the study. Patient- and     clinician-reported outcomes, and radiographic osteoarthritis will be evaluated.   "
7886|NCT03182634|"     plasmaMATCH is a multi-centre phase IIa umbrella trial platform consisting of a ctDNA     screening component and a therapeutic component. plasmaMATCH aims to assess whether ctDNA     screening can be used to detect patients with targetable mutations, and will assess the     safety and activity of the targeted treatments in patients with targetable mutations     identified at ctDNA screening.   "
7887|NCT03182621|"     Despite recommends that school-based interventions use a comprehensive approach for health     promotions; most fitness programs exclusively emphasize physical activity. This study     compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program     to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK)     fitness curriculum) on measures of physical fitness, body composition, and executive     cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a     10-week intervention period.   "
7888|NCT03182608|"     Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip     fracture using ultrasonography.   "
7889|NCT03182595|"     An open‐label, single centre, nonrandomized clinical study in healthy volunteers, with     intervention over a 13--‐week period. After written informed consent, subjects will undergo     screening evaluations (Visit 1). One week after visit 1, subjects who meet the selection     criteria will enter a run--‐in period of 8 weeks where participants will receive paracetamol     1g tablet and collect a blood sample at monthly intervals (visits 2, 3 and 4). A final visit     for safety assessment will take place at week 13 (visit 5). Blood samples will be used to     quantify P, PG e PS.   "
7890|NCT03182582|"     Bacterial load is frequently associated with impaired healing of chronic wounds. As well,     sharp debridement is often associated with pain, causing patient distress, and thereby     occasionally contributing to inadequacy of debridement, leading to a delay in wound healing.     The purpose of this study is to assess the efficacy of the Sciton Laser in reducing bacterial     load and patient distress in patients with chronic wounds, in efforts to expedite the wound     healing process.   "
7891|NCT03182569|"     Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the     usual treatment with a metal needle.   "
7894|NCT03182530|"     Data from literature: transradial access failure sometimes occurs due to inability to     cannulate the radial artery due to radial artery spasm1 causing severe difficulties in     manipulation of the guide wires and catheters along the tortuous pathways of the arteries.     both mechanical stimuli and circulating catecholamines through activation of     α1-adrenoreceptors, causing smooth muscle cell contraction & radial artery spasm   "
10091|NCT03153865|"     This is a prospective, multicenter, observational study, aiming at comparing the Safety and     effectiveness among the different surgical treatment of unruptured intracranial aneurysms in     China, so as to improve the diagnosis and treatment of unruptured intracranial aneurysms.   "
7898|NCT03182478|"     Skin Picking Disorder (SPD) affects 1.4-5.4% of the general population. It has a high     association with anxiety and depressive symptoms. Only behavioral treatments demonstrated     significant benefits compared with inactive control conditions, but with poor accessibility     of this treatment to patients. Besides this, behavioral treatment does not address the     associated anxious and depressive symptoms. Trichotillomania and SPD have co-occurrence rate     greater than expected, indicating that can be part of the same disease spectrum. The Rothbaum     Cognitive Behavioral Therapy(CBT) protocol is effective in treating trichotillomania. Based     on the similarity of these diseases, this study uses the Rothbaum Protocol to treat SPD in     individual and group format. We hypothesize that this protocol will be effective in treating     SPD, anxiety and depression symptoms associated and also facilitate therapist training.     Methods: A community sample of 40 participants with SPD will be randomly allocated to receive     treatment with the Rothbaum Protocol individually or in group format. Patients with current     psychotic disorder, suicide risk or mental disability will be excluded. Instruments measuring     anxiety, depression and SPD severity will be applied in the baseline, after the intervention     and after a 6 months follow-up. Motivation of patients to therapy will be evaluated at the     baseline. The primary outcome will be the remission of symptoms evaluated by the overall     clinical impression. The secondary outcomes will be the degree of improvement in anxiety,     depression and SPD severity.   "
7899|NCT03182465|"     CALIF study is a monocentric observational study which aim is to analyse the value of adding     procalcitonin (PCT, a pre-hormon increased in bacterial infection and septicaemia) in the     management of chemo-induced febrile neutropenia occurring in patient with solid tumour.     Febrile neutropenia will be managed according to international guidelines. PCT will be dosed     at initial presentation. Primary objective is to determine the optimal value of PCT for the     detection of septicaemia in low risk (according to MASCC score). The investigators plan also     to compare two risk stratification scores: the validated MASCC score and a recently developed     score which includes PCT and other more objective items.   "
7900|NCT03182452|"     This Clinical Study will be conducted as a comparative study focusing on usability and     efficiency by comparing alarm burden pre- and post-implementation of an Alarm Advisor     software.   "
7901|NCT03182439|"     The objective of this study is to evaluate the accuracy of four heart rate monitors in     cardiac rehabilitation patients during typical, supervised cardiac rehabilitation involving     exercise on a treadmill and/or stationary bicycle.   "
7902|NCT03182426|"     Type 1 diabetes is an autoimmune disease characterized by destruction of pancreatic     beta-cells, resulting in absolute deficiency of insulin. Presently there is no known cure.      Our proposed interventional trial is based on 'immunological reset' approach: T-depletion     therapy and anti-inflammatory treatment will restore self-tolerance in T1DM; Autologous,     peripheral-blood mobilized hematopoietic CD34+-enriched stem cells and a long-acting GLP-1     analogue will promote pancreatic islet regeneration and repair.      The short-term goals of this protocol is to demonstrate that subjects with new-onset T1DM     undergoing autologous hematopoietic stem cell mobilization and immunologic reset will have     greater preservation of endogenous insulin secretion compared to controls, and foremost that     this nonmyeloablative treatment is safe, without the need for chronic immune suppression.   "
7903|NCT03182413|"     Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a     documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to     placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).      Methods: 20 healthy male subjects participated in a double-blind, randomised,     incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo     (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg     flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.   "
7912|NCT03182296|"     In order to evaluate the difference in beta cell mass in women with and without a history of     gestational diabetes mellitus (GDM), investigators aim to compare quantitative PET imaging of     the pancreas between these groups. Investigators propose to measure uptake of     68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these women as a measure for beta cell     mass. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta     cell function measured by laboratory parameters. These highly relevant data within this     at-risk population for type 2 diabetes (T2D) will provide the investigators with more     information on the role of beta cell mass in the predisposition for development of T2D     leading to better knowledge on the pathophysiology of this disease. This could be of great     interest for development of new treatment options.   "
7981|NCT03181399|"     Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be     enrolled. To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in     addition to IQ, language, working memory, processing speed, emotional and behavioral     functioning, ataxia, and other neuropsychological and neurological performance indices in     children and adults genetically diagnosed with G1D receiving a regular diet at enrollment.   "
39602|NCT02767271|"     The objective of this study is to evaluate the pharmacokinetics of Luliconazole Cream 1% in     subjects with moderate to severe tinea pedis or tinea cruris.   "
7913|NCT03182283|"     Schizophrenia is a major mental illness that presents in young adulthood and affects ~1% of     the population. Impact on affected persons life is often major and life expectancy is reduced     by ~20 years. Better and more effective care models are needed to increase health in these     persons. Person-centered care have been suggested to be one way to increase efficiency in     care delivery for patients with chronical and complex conditions. The impact of     person-centered care on a inpatient psychosis care setting is now being tested.      The purpose of this study is to test whether inpatient Person-centered psychosis care (PCPC)     can        1. increase patient empowerment        2. improve patient satisfaction        3. reduce the frequency of involuntary treatments        4. reduce the duration of inpatient care and        5. reduce overall ward burden      A further purpose is to qualitatively explore which components in this complex intervention     are experienced as facilitators or barriers to the achievement of good care, from both     patient, next-of-kin and staff perspectives.      Quantitative data is collected through questionnaires from patients (measuring empowerment,     care satisfaction and perceived health) before and after an educational intervention for     staff, along with ward level measures such as care burden, number of involuntary treatments     and length of stay on ward.      Qualitative interview is used to study experiences of patients, next-of-kin and staff.   "
7904|NCT03182400|"     It is now widely accepted that autism is linked to a developmental disorder and cerebral     function.      Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F     Bonnet-Brilhault is responsible for team Autism) hypothesizes that atypical sensory     information processing, especially auditory and / or visual information, could underly the     symptoms observed in autism. A better knowledge of the typical development of the sensory and     cognitive processes must therefore make it possible in the long term to identify the     abnormalities linked to the autism spectrum disorders (ASD).      Studies in healthy subjects are therefore necessary in order to identify neurophysiological     indices of cerebral functioning and to study their evolution during normal development,     making it possible in the future to compare with populations of subjects with ASD.      The investigators intend to study the development of all the cognitive processes involved in     the processing of sensory and, in particular, auditory and visual information in humans: from     low-level perception processes to higher-level cognitive processes (attention, emotion,     language, prediction, ...). For this the investigators will use non-invasive     neurophysiological explorations (EEG, eye tracking) as well as neuropsychological     explorations (Questionnaires or spontaneous language recording).      A better understanding of the pathophysiological mechanisms underlying the symptoms observed     in autism could ultimately lead to the development of new specific therapeutic strategies,     particularly in the field of exchange and development therapy or cognitive remediation .   "
7905|NCT03182387|"     To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar     fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation     pneumonitis in comatose patients with intubated ventilation for less than 24 hours.   "
7906|NCT03182374|"     This is a two-phase multicenter, double-blind, randomized, prospective evaluation of     intra-articular injection(s) comparing APS to intra-articular HA injection(s). The maximum     study duration for each subject will be 62 months; 60 months from treatment to last     follow-up, and two additional months if the maximum visit window is realized. A total of 246     patients will be enrolled. These patients will meet specific inclusion and exclusion     criteria, but can be generally characterized as patients with painful unilateral knee OA who     have been unable to achieve satisfactory pain relief with previous conservative OA treatment.   "
7907|NCT03182361|"     Patients with craniofacial defects caused by oncologic resection, traumatic events or     congenital etiologies suffer from esthetic, functional and psychological problems. Auricular,     nasal and orbital defects can be reconstructed with implant retained extra-oral prosthesis.     The goal of this study is to evaluate implant survival in temporal, maxillary and orbital     bone, and peri-implant tissue reactions using a new implant system developed by BioComp     Industries.   "
7908|NCT03182348|"     Cardiovascular disease is the leading cause of illness and death in the world. The disease     involves narrowing of blood vessels due to deposits of fat which can become coated in     calcium. It is treated by percutaneous coronary intervention in which a balloon is passed     down the blood vessel to remove the obstruction and where appropriate a stent is placed in     the blood vessel to scaffold it.      Early stage research suggests that the growth of small blood vessels in and around the     deposits of fat and calcium leads to the growth of the deposit and may contribute to plaque     rupture into the vessel leading to clot formation the process which leads to heart attacks.     Drugs which prevent the development of these small blood vessel restrict the development of     the deposit, and those that encourage the development of these small blood vessel also     increase the development of the deposit. Researchers would like to find out more about the     system of blood vessels around deposits of fat and calcium in the larger blood vessels. This     involves looking just beneath the surface of the blood vessel wall, and requires a detailed     and accurate image. Researchers on this project would like to find out if optical coherence     tomography (OCT) is a suitable technique for imaging in this way.      OCT works like an ultrasound, but using light instead of sound waves. The additional imaging     will prolong the clinical procedure by 10-15 minutes.   "
7909|NCT03182335|"     To assess the impact of daily awakening from sedation on the amount of vasoactive medication     required in the ICU. The hypothesis of this proposal is that the amount of vasoactive drug     required to maintain an adequate mean arterial blood pressure will be reduced during a daily     awakening from sedation.   "
7910|NCT03182322|"     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta     cells. Administration of mucosal insulin in islet autoantibody-negative children who are     genetically predisposed for T1D offers the potential for inducing immunological tolerance to     beta cells and thereby protect against the development of islet autoimmunity and T1D.     Intranasal insulin has the advantage that whole protein will be exposed at the mucosa.     Therefore, the available dose of insulin when administered intranasally is likely to be     consistent between individuals. On this basis, the investigators aim to conduct a     placebo-controlled, double-blind/double-masked primary intervention pilot trial (PINIT Study)     of intranasal insulin treatment in islet autoantibody negative children to test immune     efficacy and safety in the primary prevention setting. This pilot will help to develop and     design a Phase III study aiming to test efficacy of preventing islet autoimmunity and T1D.   "
7911|NCT03182309|"     COPD and sleep apnea dyspnea syndrome represent two of the most common chronic lung diseases.     It is reported that the prevalence of COPD with sleep apnea dyspnea syndrome is also very     high. COPD and sleep apnea may have pathological or genetics interactions so that patients     having both disorders tend to have worse outcomes than either condition alone. Data     reflecting the prevalence, disease course and outcome of overlap syndrome is very limited in     China. Therefore, the aim of the study is to describe the prevalence, treatment and outcome     in Chinese patients and exploring the underlying interaction mechanism.   "
7937|NCT03181971|"     It is widely argued that the promotion of water consumption, as an alternative to     sugar-sweetened beverages, can assist in childhood obesity prevention efforts. Yet no studies     have tested this argument in real world schools where flavored milk or juices are available.     This trial will fill gaps by examining how promoting fresh water intake-both in schools that     do and do not provide access to caloric beverages -impacts children's consumption of food and     beverages both during and outside of school, and obesity.   "
7938|NCT03181958|"     Nasal high frequency oscillation ventilation is recommended as a primary mode in preterm     infants.However, It is rarely used as the noninvasive supporting mode after extubation.   "
7914|NCT03182270|"     This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary     hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows     better characterization of pancreatic cysts and improves appropriate therapeutic     decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic     cysts could impact patient management by: Ruling out malignancy for patients with benign     appearing nCLE images. Characterizing more malignant tumors in the pancreas.   "
7915|NCT03182257|"     This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with     advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid     tumors harboring NTRK gene fusions.   "
7916|NCT03182244|"     The purpose of this study is to determine the clinical benefit of ASP2215 therapy in     participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have     relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage     chemotherapy. In addition, this study will evaluate safety as well as determine the overall     efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to     salvage chemotherapy.   "
7917|NCT03182231|"     In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2     diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim     to compare quantitative PET imaging of the pancreas in this patient group before and after     surgery. Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the     pancreatic beta cells of these patients. Furthermore, investigators aim to compare uptake of     the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly     relevant data will provide investigators with more information on the contribution of the     beta cells to the mechanisms behind resolution of T2D after bariatric surgery and on the     prognostic value of pre-operative beta cell mass determination to T2D resolution. This might     be of great interest for the assessment of RYGB as an alternative therapy in patients with     T2D and a BMI <35, who currently do not meet the international guidelines for bariatric     surgery.   "
7918|NCT03182218|"     Direct oral anticoagulants (DOAC) are a new drug group that has been approved for chronic     anticoagulation of patients in atrial fibrillation or suffering acute thrombosis, between     others. The need of surgery of a patient in atrial fibrillation is round 10% per year.      Due to DOAC short time of commercialization and the lack of experience, the proper management     of DOAC when a patient in this treatment needs a scheduled or urgent procedure, has not yet     been established. This fact may mean both the decrease of the anticoagulant treatment     efficacy and the increase of the haemorrhage complications in the perioperative period.      With the aim of gaining additional information about this aspect, a multicentre, prospective     and observational study (classified by the spanish drug society, AEMPS, as non-interventional     trial, EPA-SP) about the DOAC management, before a scheduled or urgent surgery, in normal     clinical practice, is proposed.   "
7919|NCT03182205|"     This study aims to evaluate the autonomic and hemodynamic responses triggered by inspiratory     muscle exercise in prehypertensive and hypertensive individuals. The reason that leads us to     this study refers to clinical relevance for individuals with high blood pressure levels,     since this type of exercise can act as a important nonpharmacological agent for arterial     pressure control. In addition, this study aims to elucidate the mechanisms involved in     cardiovascular responses to inspiratory muscle exercise and, consequently, provide safety in     the prescription of these for this population.   "
7920|NCT03182192|"     Hyperinsulinemic hypoglycemia (HH) is a rare complication that occurs 1 to 5 years after     gastric bypass surgery. The underlying mechanism of this complication is not yet completely     understood. Changes in hormone levels, such as GLP1 after RYGB, nesidioblastosis or an     increase in the number of beta cells may be one of the underlying causes. However, several     study results are conflicting and it is hypothesized that the patient population with HH     after RYGB is heterogeneous and several underlying causes may be present. In order to     differentiate between hyperfunction with normal beta cell mass and a general or localized     increase in beta cell mass we aim to compare quantitative 68Ga-exendin-4 PET imaging of the     pancreas between patients with and without HH after RYGB. Thereby, investigators aim to     increase the insight in the underlying mechanism of HH after RYGB. If different underlying     causes can be diagnosed, treatment for HH can be optimized for patients.   "
7921|NCT03182179|"     Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by     4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron     (P-O sequence). It will be one week of washout between the two treatments.      During the treatment questionnaires will be completed by the patients to evaluate the     efficacy of the study treatment and the quality of live.   "
7939|NCT03181945|"     There are no guidelines or studies evaluating duration of anti-epileptic drugs in central     nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic     brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan     to conduct this study to decide the optimal duration of anti-epileptic drug in acute     symptomatic seizure in central nervous system infections   "
7922|NCT03182166|"     It is planned to enroll 80 UC patients who will require optimization of golimumab after     secondary LOR. The review of the study protocol and its approval by an Independent Ethics     Committee of the University of Saint Etienne are pending. All patients enrolled will give     their written informed consent before being included. This study will be conducted in     accordance with the ethical principles that have their origins in the Declaration of     Helsinki, in compliance with the approved protocol, good clinical practice and applicable     regulatory requirements. Patients will visit the investigator from screening visit to visit 6     at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation,     patients will record clinical parameters required to calculate the partial Mayo score     reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8     (optional) and at the end of the follow-up to calculate total Mayo score.   "
7923|NCT03182153|"     Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days     of monitoring.   "
7924|NCT03182140|"     The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with     Kyleena in a real-life setting and to identify factors which influence user satisfaction,     taking into account previously used contraceptive methods and reasons for use of Kyleena.   "
7925|NCT03182127|"     • Elbow pain is any type of pain that comes from structures in the elbow joint and/or in     structures adjacent to the elbow joint. elbow is a complex joint; it allows to both extension     and flexion, as well as rotation hand and forearm. Since most movements are a combination of     these actions, Elbow pain is often caused by overuse, but in general, elbow joint is much     less prone to wear-and-tear damage than are many other joints. The causes of elbow pain are     numerous. Most elbow pain is due to overuse or strain on the elbow joint components, but some     causes are due to trauma, infection, and/or autoimmune processes and neoplasm. Risk factors     for elbow pain are numerous and range from engaging in repetitive activities and     participation in sports to those associated with infection, trauma, and rheumatoid arthritis.     Other adjacent structures associated with elbow pain include the shoulder, upper arm,     forearm, and wrist and hand joints.   "
7926|NCT03182114|"     In this study, we will investigate the effect of left lateral tiling performed after spinal     block on maternal hemodynamics compared to ordinary supine position   "
7927|NCT03182101|"     This project will test a measure of treatment quality, Exposure Guide, for therapists using     exposure therapy for youths and young adults with anxiety or OCD. We anticipate that users of     this measure will be able to complete it reliably, find it acceptable, and that the measure     will predict patient outcome. This project will include 40 therapists treating 300 anxious     youth and young adults ages 5-21 at a large community mental health agency. Results of this     study will establish the Exposure Guide as a measure of exposure quality in real world     settings.   "
7928|NCT03182088|"     three doses (0.05 mcg/Kg/min, 0.1 mcg/Kg/min, and 0.15 mcg/Kg/min) of norepinephrine will be     compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.   "
7929|NCT03182075|"     Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the     economy over $2 billion annually and represents a significant public health problem. This     study aims to build on our understanding of aberrant emotional processing in OCD. The     proposed project tests whether a computerized training aimed to alter emotional processes,     can relieve repetitive thoughts and behaviors.   "
7930|NCT03182062|"     The purpose of this study is to determine whether individualized ventilatory management     during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of     low tidal volumes, alveolar recruitment maneuvers, individually titrated positive     end-expiratory pressure and individually indicated ventilatory support will decrease     postoperative pulmonary complications, ICU and hospital length of stay compared to a     standardized Lung Protective Ventilation (LPV).   "
7931|NCT03182049|"     The ultimate goal of this prospective natural history study is to define the natural history     of the obstructive airway manifestations of Granulomatosis with polyangiitis (GPA).      Additionally this proposal seeks to develop biomarkers of disease activity and define their     correlation with clinical outcomes in an effort to transform clinical care and shape future     drug development for this devastating rare disease.   "
7932|NCT03182036|"     The main purpose of this study is to learn how patients breathe on portable oxygen     concentrators (POCs), and to get feedback from patients using POCs.   "
7933|NCT03182023|"     Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane     Oxygenation are not known in china.A cross-section survey will be performed to assess the     long-term outcome of these patients.   "
7934|NCT03182010|"     The aim of this randomized control trial is to compare the residual myometrial thickness and     the depth of cesarean section scar defect after uterine incision closure with barbed or     conventional sutures.   "
7935|NCT03181997|"     As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic     patients with severe aortic stenosis (AS) at high surgical risk. As cancer therapy improves,     some AS patients suffering active malignancy (including advanced metastatic diseases) may be     more endangered by their untreated valvular disease than their oncological disease. Among     these patients, TAVI may be indicated before cancer related surgery or cardiotoxic     anti-cancer therapy in order to achieve better anti-cancer therapy outcomes. Individualized     life expectancy assumptions should be evaluated by the heart team in the clinical     decision-making process as an essential factor in weighing the risk-benefit ratio for     oncologic patients undergoing TAVI. A multicenter, international TAVI in Oncology Patients     with AS (TOP-AS) registry was designed to collect data on patients with an active malignancy     and severe AS undergoing TAVI. The aim of the study is to evaluate the outcomes, benefits and     risks of oncology patients undergoing TAVI, mainly the patients' survival and cause of death     and also the interactions between the valvular and the oncologic conditions.   "
7936|NCT03181984|"     This study is to provide safety information of hemoporfin during the post-marketing period as     required by China Food and Drug Administration (CFDA) regulations in order to identify any     potential drug related treatment factors in the Chinese population, such as     unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine     drug uses.   "
7940|NCT03181932|"     This study is a multi-center, randomized phase III study to evaluate the clinical     effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.   "
7945|NCT03181867|"     Background:      Prostate cancer is the second leading cause of cancer deaths in American men. When prostate     cancer is confined to the prostate there is a high chance of cure. However, it is outside the     prostate or comes back after treatment, additional therapy may be needed. Current methods of     imaging prostate cancer are limited. Researchers want to see if a radiotracer called     18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading     outside the prostate or who have signs of recurrent cancer after treatment.      Objectives:      To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or     after therapy.      Eligibility:      Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed     after radiation or surgery      Design:      Participants will be screened with medical history and physical exam. They will have blood     taken.      Participants will be divided into 2 groups.        -  Group 1 will be men with cancer that has been newly diagnosed as high risk by their          doctor who are scheduled to have prostate removal surgery or undergo biopsy before          radiation therapy.        -  Group 2 will be men who have presumed prostate cancer relapse after prostate removal          surgery or radiation therapy.      Both groups will have scans taken. Participants will lie still on a table in a machine that     takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.      Participants will be contacted for follow-up after scans.      Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove     some prostate tissue. This procedure will be standard of care and is not a part of this     study. They will also have an extra MRI scan of their prostate. For this, a tube, called an     endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside     of their pelvis. A contrast agent will be given by IV.      Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of     abnormalities found on the 18F-DCFyL scan.      Participants will have data about their prostate cancer collected for up to 1 year.   "
32756|NCT02856997|"     The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE     regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.   "
7947|NCT03181841|"     Numerous psychiatric and neurodegenerative diseases like schizophrenia, dependency on drugs     of abuse, depression and Parkinson's disease are related to motivational and cognitive     deficits in value-based decision making, which frequently persist even after a successful     pharmacological treatment. According to current neurobiologic models, cortical dopamine D1     receptors play a crucial role in taking value-based decisions. In this study, it will be     investigated whether value-based decisions in healthy volunteers can be improved by     stimulation of D1-receptors. For this purpose, a newly developed dopamine D1-agonist will be     used, which selectively increases the activities of frontal D1- and D5-receptors. In this     double-blind, randomized, placebo-controlled study, the effects of different single doses of     PF-06412562, a not yet licensed D1-agonist, on value-based decision making will be compared     with placebo. The use of different dosage strengths will allow to investigate a potential     relationship between the extent of activity of the D1-receptor and its influence on     behavioral indices.      Therefore, four parallel groups will be investigated. Each participant takes in a single dose     of either PF-06412562 in different doses or placebo. A screening exam will be carried out 1-3     weeks before the drug intake, and a follow-up examination will be carried out approx. 1 week     after the drug intake. At all 3 visits in the study centre, several tests for the     investigation of value-based decision making will be carried out.   "
7948|NCT03181828|"     The objective is to determine if acetohydroxamic acid (AHA) can prevent hydrolysis of urea by     inhibiting the bacterial urease of gut flora of both healthy control adults as well as adults     with urea cycle disorders   "
7949|NCT03181815|"     The vast majority of patients with AML will die of the disease, and no standard chemotherapy     regimen were defined for patients with relapsed/refractory AML. Previous studies have     confirmed the efficacy of cladribine in the treatment of AML, both de novo or     relapse/refractory AML. Our previous experience has shown that Cladribine in combination of     CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable     toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and     safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG)     in patients with refractory/relapsed acute myeloid leukemia.   "
7950|NCT03181802|"     Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A)     requires further studies to confirm the reported short-term therapeutic effect and to     determine potential predictive factors of efficacy.   "
7951|NCT03181789|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two     HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant,     given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected     adults.   "
7952|NCT03181776|"     The aim of this work is to investigate the effect of different angles of lateral tilt on the     maternal hemodynamics before and after subarachnoid block   "
7953|NCT03181763|"     This study will examine how the drug methylenedioxymethamphetamine (MDMA) impacts response to     different types of memory in humans compared to placebo. MDMA is an experimental drug and is     illegal to possess outside of research; when sold illegally it is referred to as Ecstasy or     Molly (material supposedly containing MDMA). MDMA may make it easier to face unpleasant     memories and reduce anxiety, and it may do so in part by influencing response to memories.     This study will enroll healthy adults. At visit 1, participants will undergo a 1-hour startle     test. The startle test measures eye-blink response to loud sounds. After this, the     participant will also view different colored shapes presented on a computer monitor. While     watching the computer monitor, the participant will experience several brief blasts of air     directed at the throat. The following day at visit 2, participants will be randomized to     receive placebo or 100 mg MDMA and will complete tasks similar to the ones completed the     previous day. The researchers will measure pulse, blood pressure and temperature once before     and seven times after receiving MDMA, and study participants will complete a questionnaire     about their experience. Two days after receiving MDMA or placebo, participants will return     for a third visit to complete similar tasks to previous visits. This study will also measure     sleep through a sleep diary and actigraphy, which is a device worn on the wrist like a watch     that records movement during sleep and lets researchers see how much sleep a person is     getting.   "
7954|NCT03181750|"     Palliative care is a priority area of focus for the National Institute of Nursing Research.     Despite the evidence-based benefits of palliative care, access remains limited, especially in     poor urban and rural settings. Cultural and linguistic barriers may also increase disparities     in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and     the unique cultural preferences and values of patients, our innovative study has the     potential to improve palliative care outcomes and reduce health disparities in both urban and     rural underserved communities.   "
7982|NCT03181386|"     The purpose of this study is to evaluate the safety of a protocol which does not suspend the     new oral anticoagulants (dabigatran, rivaroxaban and apixaban) in front of dental extractions     in patients with non-valvular atrial fibrillation.   "
7955|NCT03181737|"     The trial aim of the study is to evaluate the effectiveness of a novel psychological internet     intervention (Covivio), which was designed to improve adherence in Persons with Diabetes     Mellitus type 2 (PwDM), using cognitive-behavioral therapy (CBT) techniques. Therefore, 300     PwDM will be recruited and randomized to three groups:      (1) a treatment group that immediately receives two-month access to Covivio and may also use     care-as-usual (CAU), (2) an active control group that also immediately receives a two-month     access to Relaxio, an internet program with the focus of stress relaxation ,and may also     additionally use CAU or (3) a control group, in which they may engage with any diabetes     treatment (i.e. CAU/ wait list control group). The active control group (2) and the wait     control group (3) receive access to Covivio after a delay of six months. The primary outcome     measure is the Diabetes Self-Management Questionnaire-Revised (DSMQ-R), collected at     baseline, two (post-treatment), and additionally three and six months follow-up.   "
7956|NCT03181724|"     The investigators plan a prospective randomized controlled study that compares whether the     use of a decision aid results in different scores on variables reflective of the     decision-making process, behavior, health outcomes, communication, and healthcare system.   "
31335|NCT02875600|"     To determine the difference in baseline MR flow measurements and post-prandial MR flow     measurements between patients diagnosed with CGI and patients not diagnosed with CGI.   "
7957|NCT03181711|"     BACKGROUND: To diagnose caries in clinical practice today, a combination of clinical     examination with mirror and probe, and in sometimes x-ray images are used. For surfaces in     contact with other teeth X-rays (preferably bitewing) are often required. Even though the     radiation doses in bitewings are small, it is important to weigh risks against the benefit to     avoid unnecessary radiation.      There are other methods for diagnosing caries based on different forms of laser light. One     such technique is based on the translucency of the teeth. The light is within the near     infrared light (NIR) area. A product named DAIGNOcam (diagnostic camera) is using this     technology. The light is led in a hand piece held against the tooth. The tooth is illuminated     and the caries lesions can be seen like dark spots on a computer monitor screen. The     technique is mainly used in adult patients and permanent teeth. However, there is no complete     evaluation of how well the technology diagnoses caries in milk teeth. From a radiation     hygiene point of view, it is particularly important to reduce the amount of X-rays to young     individuals. X-rays are often experienced as difficult by younger children, which leads to     poorer diagnostics. It is important to identify early caries in milk teeth as these teeth     have thinner enamel and a more porous dentin. This may lead to that caries progress much     faster thus more difficult to fix. This in turn leads to a risk of toothache and that the     damage becomes so extensive that the tooth must be removed.      OBJECTIVE: To investigate diagnostic accuracy / precision in caries diagnosis between teeth     using DIAGNOcam in milk teeth comparable to caries diagnostics using bitewing x-rays.      RESEARCH QUESTIONS:        -  Is DIAGNOcam a reliable diagnostic method for diagnosing caries in between teeth          (approximal caries) in milk teeth?        -  How does child experience caries diagnosing performed with DIAGNOcam compared to X-rays?          INVESTIGATION VARIABLES: Caries data are recorded according to the accepted diagnostic          method at the surface level. Each examined tooth surface is assessed as either 1)          intact; 2) caries only in enamel; 3) caries i dentin; or 4) the surface can not be          judged. The same classification is used for X-rays and DIAGNOcam.      The children will also be able to rate their experience of the X-ray examination and the     DIAGNOcam survey using a Faces pain scale to see if there is any difference in experience     between the different methods of investigation.   "
7958|NCT03181698|"     Bipolar disorder is a complex psychiatric disorder characterized by recurrent episodes of     mania or hypomania and depression, and affects around one to three percent of the population     . Bipolar Disorder is associated with significant psychosocial morbidity and mortality , and     is among the leading causes of disability worldwide . The disease is highly heritable, but     the underlying pathophysiology is not yet understood .   "
7959|NCT03181685|"     This randomized, controlled, prospective, crossover, open-label, two-treatments, two-period     trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous     administration of progesterone versus the vaginal one.      The couples, scheduled for performing 2 In Vitro Fertilization (IVF)/Intracytoplasmic Sperm     Injection (ICSI) cycles will be randomized to receive, as luteal phase supplementation,     Pleyris 25 milligram (mg) (a single subcutaneous administration per day) or Prometrium 200 mg     (3 vaginal administrations per day).   "
7960|NCT03181672|"     To investigate the influence of stellate ganglion block on tourniquet response during surgery     in patients undergoing elective lower limb Department of orthopedics.   "
7961|NCT03181659|"     This clinical trial study evaluates the effectiveness of a multimodal physiotherapy treatment     based on a biobehavioural paradigm in the treatment of non-specific chronic low back pain.     The experimental group received treatment based on therapeutic exercise, education in     neuroscience, and manual therapy, contrary to the control group, which did not receive manual     therapy treatment.   "
7962|NCT03181646|"     Citicoline, is a naturally occurring compound and an intermediate in the metabolism of     phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of     the cell membranes. Citicoline is composed of two molecules: cyti¬dine and choline. Both     these molecules enter the brain separately and by passing through the blood-brain barrier     where they act as substrates for intracellular synthesis of CDP-choline . This drug has been     widely used in adults who suffer from acute ischemic strokes for than 4 decades with good     results and has been proved to have a very good safety profile as well. It has various     therapeutic effects at several stages of the ischemic cascade in acute ischemic stroke.        1. It stabilizes cell membranes by increasing phosphatidylcholine and sphingomyelin          synthesis and by inhibiting the release of free fatty acids . By protecting membranes,          citicoline inhibits glutamate release during ischemia. In an experimental model of          ischemia in the rat, citicoline treatment decreased glutamate levels and stroke size.        2. Citicoline favors the synthesis of nucleic acids, proteins, acetylcholine and other          neurotransmitters, and decreases free radical formation Therefore, citicoline          simultaneously inhibits different steps of the ischemic cascade protecting the injured          tissue against early and delayed mechanisms responsible for ischemic brain injury.        3. citicoline may facilitate recovery by enhancing synaptic outgrowth and increased          neuroplasticity with decrease of neurologic deficits and improvement of behavioral          performance.      Considering these pharmacologic properties of citicoline, we are planning to see its effects     in newborns who have HIE which causes a global acute ischemic changes in developing brain.   "
7963|NCT03181633|"     The purpose of this study is to evaluate long term safety and efficacy of ACH-0144471 in     patients with PNH who have demonstrated clinical benefit from ACH-0144471 in Clinical Study     ACH471-100. This study is designed to include up to 12 patients.   "
7983|NCT03181373|"     Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years     period.   "
7994|NCT03181230|"     This study plans to learn more about how the energy system works in girls with Turner     syndrome. This is important to know so that the investigators understand how Turner syndrome     relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and     how this impacts day to day life.   "
7964|NCT03181620|"     SATIRE is a prospective, randomized control trial assessing two methods of administration of     intravenous sedation and narcotics in surgical patients requiring mechanical ventilation.     Many hospitals use a continuous infusion method of administering these medications. The     investigators hypothesize that intermittent, bolus/sliding-scale based administration will     lead to less medication being given and subsequently decrease the amount of time on     mechanical ventilation without compromising patient comfort or level of sedation.      Patients are randomized into a control arm (continuous infusion) and a trial arm (sliding     scale hourly bolus) using versed for sedation and fentanyl for pain medication. Inclusion     criteria are surgical patients requiring mechanical ventilation, including trauma patients,     post operative patients, etc.      Primary end point is total time of mechanical ventilation in each arm. Secondary end points     are amount of medication given, time in ICU, time to discharge. Mortality and adverse events     in both arms are recorded and reported to the Institutional Review Board for monitoring.   "
8190|NCT03178682|"     evaluation of the role of ultrasonographic parameters (mean gestational sac diameter, yolk     sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in     predicting early pregnancy failure in patients with recurrent pregnancy loss   "
7965|NCT03181607|"     Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic     countries. Although active-passive immune prophylaxis is generally administrated to infants     delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High     HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF     （tenofovir） or LDT（telbivudine） to treat patients with high HBV DNA load during middle, late     pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported     in late years. Recently, American Association for the Study of Liver Diseases, European     Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis     B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28     weeks of gestation to lower MTCT of HBV.      Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that     MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or     LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the     long-effect of TDF or LDT on infants remains unclear thoroughly.      Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine     liver protection therapy could not effect. Some of them could develop into liver failure,     fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse     effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature     birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during     early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating.      Taken together, the investigators will enroll women with chronic HBV infection and evaluate     their state of illness. Then the investigators treat participants with TDF or LDT or routine     liver protection therapy, and follow up the participants for a long period. The     investigators' objectives are as follows:      A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between     immune-tolerant and immune-active CHB patients.      B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different     trimesters of pregnancy.      C, To compare MTCT rate between patients received TDF/LDT therapy and patients without     TDF/LDT therapy.      D, To compare MTCT rate and adverse effects between LDT and TDF.   "
7966|NCT03181594|"     A multi-center, prospective, non-randomized, interventional clinical trial to assess the     safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the     nose of subjects with chronic rhinitis.   "
7967|NCT03181581|"     Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There     seems to be an agreement that achieving extensive resections, when done safely without     jeopardizing neurological function, improves survival.      Ultrasound is currently used as a tool for providing 2D or 3D images for tumor localization     and resection control. For the use in resection control the resection cavity is filled with     saline to provide acoustic coupling between the ultrasound transducer and tissue. However,     attenuation of acoustic waves is very low in saline compared to the brain and this difference     in attenuation is the cause of artifacts that may severely degrade the ultrasound images.     Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. The     artificial signal enhancement can potentially mask small tumor remnants and is generally     making the interpretation of images more difficult.      This research group has developed an acoustic coupling fluid intended for use in the     resection cavity instead of saline. Tests in laboratory measurements have shown that the     fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain     tumor surgery. Three different concentrations of the acoustic coupling fluid have been tested     in a phase 1 study that included 15 patients with glioblastoma. The concentration that     provided the optimal ultrasound images, from qualitative and quantitative inspection, is used     in the current phase II study. This study is a randomized controlled trial aiming to include     82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of     glial brain tumours to further investigate safety and efficacy.   "
7968|NCT03181568|"     12-week single-blind, prospective, randomized, controlled, pilot clinical trial assessing The     MolecuLight i:X Imaging Device in chronic wounds. This device guides clinicians to inspect,     sample, debride or further evaluate areas within or around a wound where potentially harmful     bacteria appear under violet light illumination resulting in better overall care and     accelerated surface area reduction compared to current standard care. The study aims to     determine if this device aids in the healing of chronic wounds by reduction in size of wound     compared to current standard of care.   "
7969|NCT03181555|"     1. Determine if the stool or vaginal microbiome and urinary metabolite profiles in a          pregnant obese population of African American women differ from their pregnant non-obese          counterparts        2. Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by          class of obesity and magnitude of excess weight gain in this population of pregnant          African-American women.        3. Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination          of all biomarkers as predictors of preterm birth (PTB) and onset of labor.        4. Determine if any dietary or clinical variables are correlated with changes in the          microbiome or urinary metabolites or modify their association with PTB   "
7970|NCT03181542|"     The objective of the study is to assess the efficacy of the vein visualization device     AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for     establishing intravenous (iv) access in the infant and toddler population (<2years)   "
7971|NCT03181529|"     The proposed pilot study will assess whether people with major depressive disorder experience     psychological and behavioral benefits and/or harms from psilocybin. This study will     investigate acute and persisting effects of psilocybin on depressive symptoms and other     moods, attitudes, and behaviors. The primary hypothesis is that psilocybin will lead to rapid     and sustained antidepressant response, as measured with standard depression rating scales.   "
7992|NCT03181256|"     This research trial studies the long term follow-up for early detection of lung cancer in     current or former smokers. Following up on smokers by collecting and analyzing specimens in     the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical     records may help doctors detect lung cancer at an earlier stage.   "
7993|NCT03181243|"     To compare the acceptance, safety, and efficacy of needle-free jet anaesthetic technique     (MadaJet) versus needle injection for sperm retrieval in patients with azoospermia.   "
7972|NCT03181516|"     Probiotics are live microorganisms that, when administered in adequate amounts, confer a     health benefit on the host. One of the most common indications for probiotic treatment is the     prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products     used for AAD are not supported by rigorous independent research, and often results in     non-evidence-based usage. The overarching objective is to move research forward for the most     well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose,     BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children     receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented     with BB-12, and to carry out longitudinal community structure and gene expression analysis of     fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population     receiving antibiotics. The microbiota includes hundreds of species, and its disruption is     hypothesized to be an important factor in the development of AAD.   "
7974|NCT03181490|"     Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify     lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to     differentiate between malignant and benign nodules.      In previous studies, we had taken the approach of methylation profiling by high throughput     bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. We     had learned methylation patterns that differentiate malignant vs. benign lesions from tissue     samples by in-depth data mining, and then used pattern matching to classify plasma samples.      In this study, we are going to validate the efficacy of ctDNA methylation test for diagnosing     early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the     post-surgery pathology.   "
7975|NCT03181477|"     Glioblastoma (GBM) is the most aggressive and most frequent brain tumour. Approximately four     people per 100,000 inhabitants are diagnosed with this disease every year. The standard     treatment comprises surgical resection (whenever possible), normofractionated radiotherapy at     a dose of 60Gray (Gy) and temozolomide (TMZ). Median overall survival in these patients is     14.6 months [13.2-16.8].      In a previous phase I clinical trial, dose escalation tolerance using simultaneous-integrated     boost intensity-modulated radiation therapy (SIB-IMRT) technic has been evaluated. The     investigator demonstrated that SIB-IMRT until a dose of 80Gy in 32 daily fractions,     associated with TMZ is feasible and well tolerated by patients with glioblastoma.      The aim of this present phase II clinical trial is to evaluate the overall survival at 18     months for patients with glioblastoma receiving TMZ, according to standard protocol,     associated to radiotherapy delivered at 80Gy using SIB-IMRT technic. The first planning     target volume (PTV), including oedema and tumour highlighted on T2 flair magnetic resonance     imaging (MRI) sequences, will receive 60.8Gy in 32 daily fractions. The second PTV, including     tumour highlighted on T1 MRI sequences, will receive 80.0Gy in 32 daily fractions.      Secondary objectives are tolerance, survival free progression and quality of live     evaluations.      Sixty seven patients will be enrolled in this present trial.   "
7976|NCT03181464|"     During labor and delivery, pregnant women may choose to receive pain relief called epidural     analgesia, which is the delivery of a numbing agent through the back and into a body space     around the spinal column. This numbs the area of the stomach and the pelvis. Typically the     numbing agent is lidocaine, which is a local anesthetic like your dentist uses. Some times     the numbing agent is combined with another medication that causes drowsiness and relieves     pain called a narcotic. One of the risks associated with having this kind of pain relief is     unintentional puncture of a sheath of tissue that surrounds and protects the spinal cord when     inserting the needle. This sheath is called the dura. This would cause the fluid surrounding     the spinal cord to leak out and this would cause a headache. This headache is called a     post-dural puncture headache [PDPH]. The headache can be mild or severe. Rarely, PDPH can be     serious and cause bleeding or small clots in the brain and damage to nerves that come out of     the brain.      The purpose of this study is to test the use of a technique that uses a hollow cotton swab     [no needles] to numb a nerve cell cluster that sits at the very back of the nasal cavity. The     anatomical name for this nerve cell cluster is the sphenopalatine ganglion. This has been     done before at BJH and other hospitals with positive results, but no formal studies have been     conducted here. Also, the sphenopalatine ganglion [SPG] has been the treatment target for     other kinds of headaches. To numb the SPG, a hollow tip cotton swab [like a long Q-Tip] is     inserted through the nose to the back of the nasal cavity and a solution of numbing agent is     slowly pumped through the hollow Q-tip. This study will include a group that will receive a     salt solution through the swab instead of a numbing agent. Subjects will be offered BJH     standard care for their headache if they do not have relief from the study procedures.     Standard care would be decided by their treating physician and may include oral pain     medications and/or medications like ibuprofen [Motrin] or they could have a procedure called     an epidural blood patch. This is performed by injecting a small amount of the patient's own     blood into the areas of the spinal column where the original epidural anesthesia was injected     in order to patch the leaks in the dura.   "
7977|NCT03181451|"     The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric     Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in     comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.   "
7978|NCT03181438|"     The objective of this study is to evaluate the efficacy and safety of transverse abdominal     plane block in patients undergoing renal transplant surgery.Adult renal transplant recipients     will be prospectively randomized to receive a standard general anesthetic technique     supplemented with ropivacaine 0.375% 20 mL TAP block or sham block with 20 mL 0.9% saline.     Both groups will receive patient-controlled morphine analgesia. Patient assessment will occur     in the postanesthetic care unit and at 1, 2, 4, 6, 12, and 24 hours. The primary outcome is     total morphine consumption in the first 24 hours after renal transplantation. Other outcomes     asses include pain scores, presence of nausea or vomiting, excessive sedation, and     respiratory depression.   "
7979|NCT03181425|"     The aim of this study is the evaluation of new MRI tractography maps for early knee     osteoarthritis assessment.   "
7980|NCT03181412|"     The effectiveness of acute ischemic stroke (AIS) management has improved considerably in     recent years with thrombolysis and more recently with mechanical thrombectomy (MT).     Currently, mechanical thrombectomy can only be performed in stroke unit with an     interventional neuroradiology center by experienced/qualified interventional     neuroradiologists. In the Rhone area, only one hospital has the authorization to perform     mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke     patients for mechanical thrombectomy to this center constitutes an important stake of the     triage of suspected acute ischemic stroke patients. Some validated scores for the     identification of severe strokes and large vessel occlusion, including the Cincinnati     prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in     order to identify patients potentially eligible for mechanical thrombectomy and address them     to a stoke unit with interventional radiology center.   "
7984|NCT03181360|"     Stroke is a leading causes of death and disability. At least 20% of strokes occur during     sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is     effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom     onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy.     Previous studies indicate that many wake-up strokes occur just before awakening.      In this study, patients with wake-up stroke will be randomized to thrombolysis with     tenecteplase and best standard treatment or to best standard treatment without thrombolysis.     Tenecteplase has several potential advantages over alteplase, including very rapid action and     that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done     to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT     scan to inform this decision. CT is used as a routine examination in all stroke patients.     Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more     complex brain scans, which are not routinely available in the emergency situation in all     hospitals.   "
7985|NCT03181347|"     Obesity and its associated diseases are increasing worldwide. However, the mechanisms behind     the development of obesity is not fully understood. There is evidence that intestinal     bacteria may play a role in the development and perpetuation of obesity through regulation of     energy and fat storage.      Bariatric surgery is currently the most effective modality for treating severe obesity with     evidence to support long-term sustained weight loss and improvement in obesity-related     comorbidities. The two most commonly performed bariatric surgical procedures are the     Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). RYGB leads to greater weight     loss than SG and improved diabetes control in patients following surgery. Despite the success     of RYGB and SG in inducing weight loss and improving comorbidities, the underlying mechanisms     leading to clinical improvement following these operations is not completely understood.     Multiple factors are thought to play a role including reduced caloric intake, decreased     nutrient absorption, increased satiety, release of hormones and shifts in bile acid     metabolism.      Recent evidence has suggested that the gut bacteria mediates a number of the beneficial     effects of bariatric surgery. Small studies have demonstrated changes in the composition and     diversity of the gut microbiota after RYGB and SG in humans. One study also confirmed     long-term microbial changes for RYGB. However, comparative trials have been small (less than     15 participants per treatment group) and important differences between specific bacterial     populations have not been well elucidated. Furthermore, no human study has examined the     differences in bacterial composition following RYGB and SG in relation to their metabolic     consequences.      The aim of this study is to investigate and compare the metabolic and microbial changes that     occur with RYGB, SG, and dietary controls. Specifically, we aim to use a systems biology     approach utilizing powerful analytic techniques including metagenomics, metabolomics, and     multiplex immune profiling to define the combined microbial, metabolic and immunologic     changes that occur after bariatric surgery.   "
7986|NCT03181334|"     Participants will be mailed an invitation to complete CRC screening along with a fecal     immunochemical test (FIT) kit, containing a 1-sample Polymedco OC Sensor FIT, simplified     English/Spanish instructions on performing the test, educational information about colorectal     cancer screening and a return mailer with prepaid postage.      Processes that will be used to promote screening completion include automated and live     phone call reminders to encourage completion of FIT testing.      Participants will be randomly assigned to 1 of 5 study arms across 3 conditions, described     below:        1. Condition 1 (Pure Control):             -  Branch I: Participants assigned to the control condition will receive a FIT kit and               the standard invitation letter to participate in free screening.        2. Condition 2 (Time Restriction):             -  Branch II: Participants will receive a FIT kit and invitation letter to participate               in free screening with a 1-week time restriction.             -  Branch III: Participants will receive a FIT kit and invitation letter to               participate in free screening with a 3-week time restriction.        3. Condition 3 (Time Restriction + Incentive):             -  Branch IV: Participants will receive a FIT kit and invitation letter to participate               in free screening requesting they return the kit within 1-week for a $20 incentive               or within 3 weeks for a $10 incentive.             -  Branch IV: Participants will receive a FIT kit and invitation letter to participate               in free screening requesting they return the kit within 1-week for a $10 incentive               or within 3 weeks for a $5 incentive.      Participants with a normal test result will receive a personal letter confirming this with     invitations to complete a repeat screening in subsequent year(s). Participants receiving an     abnormal FIT result will be navigated to complete a diagnostic colonoscopy.      Participants continuing in the screening program in subsequent years will receive letters     emphasizing the importance of repeat screening to prevent adverse CRC outcomes.   "
7987|NCT03181321|"     The purpose of this study is to assess the efficacy of an internet-based firefighter health     and wellness program for volunteer fire departments.   "
7988|NCT03181308|"     This is a multicenter, open-label, nonrandomized, Phase 1b, dose-escalation study of     Carotuximab (TRC105) in combination with standard dose Nivolumab in patients with metastatic     NSCLC.   "
7989|NCT03181295|"     Despite knowing that exercise improves health, primary care providers (PCPs) do not regularly     assess physical activity (PA) levels or use proven techniques to help patients to increase     their PA levels. Studies have shown that PCPs don't talk to patients about their PA levels     because they don't feel they have adequate knowledge or resources to help their patients.     Additionally they don't feel they have time to provide personalized advice regarding PA.      This study will use tablet computers and email to engage patients in contemplating their own     PA levels and starting conversations with their PCPs. Electronic surveys delivered via     tablets and email prior to periodic health reviews will be used to support customized,     patient-centred health care. The patient's survey responses will be used to develop a     printable 'toolkit' with individualized PA recommendations, a personalized exercise     prescription (Rx), as well as patient-specific educational and community resources. The     exercise Rx and resources can be edited by the PCP based on the resulting discussion between     patient and PCP.      The overarching aim of this study is to determine how the use of technology in family     doctors' offices can help patients to engage with their PCPs regarding PA and ultimately     increase their PA levels.   "
7990|NCT03181282|"     While deep brain stimulation of the subthalamic nucleus (STN-DBS) is commonly used to reduce     tremor, muscle stiffness, and bradykinesia in people with Parkinson disease (PD), preliminary     studies suggest balance may worsen and falls may increase after STN-DBS. Walking speed, known     to be reduced in PD, typically improves after surgery; however, other important gait     qualities may not improve. Given the potential for worsening balance and gait and increasing     falls after surgery, it is imperative that researchers explore interventions that complement     the positive effects of STN-DBS and delay worsening of balance and gait.      Physical therapy (PT) is reported to be effective in improving balance and walking in people     with PD. However, there have been no studies to investigate how individuals with STN-DBS     respond to PT. As such, it is unclear if exercise in the post-DBS population is safe,     feasible, and effective. The purpose of this study is to examine the safety, feasibility, and     efficacy of PT in people with PD with STN-DBS.      The investigators hypothesize that PT will be safe and feasible for people with PD with     STN-DBS. Further, the investigators hypothesize that those assigned to PT group will     demonstrate improvements in balance and gait while those assigned to the control group will     demonstrate no change or a decline in balance and gait.   "
7991|NCT03181269|"     This study will explore the effects of skin-to-skin contact (SSC) between mothers and their     babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk     microbiome. This will be accomplished by administering an intervention education session to     one group and a placebo education session to the second group in order to influence the     magnitude of total SSC defined by the frequency and duration of contact time between the two     groups.   "
7995|NCT03181217|"     The study will consist of four occasions with one week between the occasions. fMRI will be     performed to monitor hypothalamic activity before and after an ingestion of 1 of the     following 4 stimuli (300 ml of each): water at room temperature, water at 0 degrees Celsius,     glucose solution at room temperature, glucose solution at 0 degrees Celsius. The last two     stimuli both contain 75 gram glucose. The order of conditions will be randomly assigned to     the subjects. Functional connectivity of the hypothalamic regions will be assessed by     analysing the resting state fMRI.   "
7996|NCT03181204|"     The primary objective of this study is to to verify the feasibility of obtaining and     comparing two epithelia in two populations based on the following experiments:        -  Differentiation of an Induced Pluripotent Stem cell (iPS) clone derived from cutaneous          biopsy in a population of heavy smokers (plus patients with chronic obstructive          pulmonary disease) in order to obtain differentiated bronchial epithelia in vitro.        -  For each of these same patients, generation of bronchial epithelium in vitro from          bronchial biopsy using human bronchial epithelial cells (HBECs) in air-liquid interface          (ALI) cultures.   "
7998|NCT03181178|"     Prevention of malnutrition in infants and children requires access and intake of nutritious     food starting at birth with exclusive breastfeeding for the first 6 months of life,     breastfeeding in combination with complementary foods from 6-24 months of age, access to     clean drinking water and sanitation, access to preventive and curative health care (including     prenatal).      In Ghana, the Demographic and Health Survey of 2014 reports rates of stunting, wasting and     underweight in children aged 0-59 months are 28%, 14% and 9% respectively. Furthermore,     height for age starts dropping from age 4-6 months with children aged 6-23 months being more     likely to be stunted (40%) than those below 6 months (4%). Infant and young child feeding     data show that for breast-fed children ranging from 6 months through 35 months of age,     cereals are predominantly the first foods introduced in the diet (6-8 months of age). As the     child grows older, consumption of fruits rich in Vitamin A, other fruits and vegetables and     meat, fish, poultry and eggs are reported by the mothers. The Demographic and Health Survey     (DHS) found that the proportion of breast fed children aged 6-23 months who received a     recommended variety of foods the minimum number of times per day increases with child's age     from 28% in children 6-8 months to 50% in children aged 18-23 months.      The study objective is to examine the effect of providing a macro- and micro-nutrient     fortified complementary food supplement (KokoPlusTM) on growth and nutritional status of     Ghanaian infants.   "
7999|NCT03181165|"     Type 2 diabetes represents a significant burden to both the individual and our healthcare     system. Individuals with type 2 diabetes are typically prescribed one or more     glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk     of cardiovascular complications, weight gain) and cost our healthcare system a lot of money.     An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet.     However, adjusting medications after choosing to follow a low-carbohydrate diet can be     difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this     difficulty in medications adjustment because pharmacists are trained to adjust medications.     In this study the investigators will determine whether type 2 diabetes patients can reduce     medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under     the direction of a pharmacist.   "
8000|NCT03181152|"     To Assess the Utility of Impulse Oscillometry on a Differential Diagnosis among the Patients     with ACOS,asthma and COPD over Age 40.   "
8001|NCT03181139|"     Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy     pathway implementation.   "
8002|NCT03181126|"     This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary     efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric     participants with relapsed acute lymphoblastic leukemia.   "
8003|NCT03181113|"     In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN     study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs     level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test     every year from the second year to the fifth year after the ending of peginterferon alfa     treatment, and long-term benefit of interferon treatment will be evaluated.   "
8004|NCT03181100|"     Objectives:      Primary:      To determine if targeted therapy + atezolizumab (cohorts 1-3) will lead to improved overall     survival (OS) in patients with anaplastic thyroid carcinoma (ATC).      Secondary:        1. To evaluate the safety and efficacy (RECIST response rate, progression-free survival          [PFS]) of targeted therapy + atezolizumab (cohorts 1-3) in ATC and poorly differentiated          thyroid cancer (PDTC).        2. To determine the OS in patients with PDTC treated with targeted therapy + atezolizumab          (cohorts 1-3).        3. To determine the efficacy (RECIST response rate, progression-free survival [PFS]) and OS          of ATC and PDTC patients treated with taxanes + atezolizumab (cohort 4)   "
8005|NCT03181087|"     The purpose of this study is to evaluate the safety of umbilical cord mesenchyme stem cell     local intramuscular injection for treatment of uterine scars by a prospective, single-center,     open, and single-arm clinical trial.   "
8006|NCT03181074|"     This early post-marketing study is an observational, prospective and descriptive study of     patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating     sentinel sites for the CNFV in Mexico.   "
8007|NCT03181061|"     This national, qualitative study of physicians who provide abortion care aims to better     understand the facilitators of abortion provision among generalist clinicians in OB-GYN and     Family Medicine.   "
8008|NCT03181048|"     The study will assess the outcomes of patients treated with concomitant hip arthroscopy at     the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with     patients treated with PAO alone.   "
8009|NCT03181035|"     This is a pilot study in the form of a prospective Phase II, single centre, single arm     hypoxia study of oral tongue cancer with FAZA-PET imaging and pimonidazole targeted IHC of     surgical specimens.   "
8010|NCT03181022|"     The purpose of the Tailored Motivational Interviewing Project (TMI) is to develop an     implementation intervention to increase evidence-based patient-provider communication     strategies using a Motivational Interviewing (MI) framework.   "
8011|NCT03181009|"     Few studies have been conducted to optimize safety of oral immunotherapy(OIT) in conjunction     with Omalizumab as well as to identify the immunological mechanism(s) underlying any     long-lasting effects of OIT. To address these issues in the field of food allergy research,     we have designed this study to test whether: 1) Omalizumab improves the safety of OIT in     subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT     is associated with the ability to use a lower maintenance dose of each food allergens in the     OIT regimen, particularly in younger subjects with food allergies.   "
8012|NCT03180996|"     This study is a prospective non-interventional, multi-centre study of the Vascutek     Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek     Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal     Aortic Aneurysm.   "
8191|NCT03178669|"     The purpose of this study is to evaluate efficacy of cobitolimod treatment at different dose     levels and frequencies compared to placebo in patients with moderate to severe active     ulcerative colitis.   "
11629|NCT03133689|"     The primary aim of this study is to examine if long-term patterns of alcohol consumption are     associated with time-to-onset for incident coronary heart disease (fatal and non-fatal),     using data from multiple cohorts.   "
8013|NCT03180983|"     CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An     explanation for this increase in consumption would be aging. Thus, part of this aging     population lives in nursing home, where the urinary tract infection is the second most     suspected pathology. However, it can most often be bacteriuria requiring no antibiotic     therapy. In nursing home, nurses who alert prescribers when an infection is suspected by     describing clinical signs.However, his propensity to perform too rapidly and systematically     an examination with dipsticks leads the physician to prescribe antibiotic. This is how a     program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The     present ATOUM 4 study builds on this program.      OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving     training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic     resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a     randomized double-arm interventional study in 40 nursing home. The intervention group of 20     nursing home will receive a blended-learning intervention.   "
8014|NCT03180970|"     The purpose of this study is to assess whether lower Lugol's solution concentration can     perceive the same image quality of early esophageal squamous neoplasia.   "
8015|NCT03180957|"     Dupuytren's disease is a very common condition, affecting 4% of the general UK and US     population. It causes the fingers to curl irreversibly into the palm and can be extremely     disabling. The disease usually starts as a small firm lump (nodule) in the palm, and in about     40% of patients advances to form cords that pull the fingers into the palm. There is no     approved treatment for the early stage of disease. Once patients have established     deformities, the diseased tissue can removed by surgery or cut using less invasive techniques     such as a needle or an enzyme. However, recovery following surgery usually takes several     months and recurrence rates with the less invasive techniques are high.      The investigators have unravelled the cellular process that initiates and maintains the     disease progress and identified tumour necrosis factor (TNF) as a new target for treatment.     Based on these findings the investigators plan to test the effects of adalimumab, an anti-TNF     drug which currently approved for use in patients with rheumatoid arthritis and other     inflammatory conditions. The aim of the study is to find out whether treatment by injection     with adalimumab directly into the diseased tissue will control the advance of early     Dupuytren's disease better than a placebo injection with normal saline.      The investigators will first carry out a small trial in up to 40 patients with established     disease to determine the best dose that reduces the activity of the cells responsible for the     disorder (Dose Response study). In this part patients who will be having surgery to remove     their diseased tissue will receive a single injection of adalimumab into the nodule in their     hand about 2 weeks before surgery. The tissue that is then removed during surgery will be     analysed in the investigator's laboratories to determine the effect of the drug on the     tissue. Patients will be followed for 12 weeks after surgery.      In the second part of the study the investigators will assess whether the optimal dose of the     drug prevents early disease advancing in 138 patients (Early Disease study). Patients who     take part in the second part of the study will receive a total of 4 injections of adalimumab     into the nodule in their hand at three monthly intervals. They will then be checked at 6     months after the last injection. In additional to assessing the effect of the injections on     the nodule and hand function, information will also be collected to assess the cost     effectiveness of the treatment.   "
8016|NCT03180944|"     This study was to test an appropriate concentration of Lugol's solution which can reduce the     mucosal irritation and provide high image quality to ensure endoscopy examination by a     randomized blinded controlled trial.   "
8017|NCT03180931|"     Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE     mark) and is used in daily clinical practice. While recent randomized controlled trials     comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable     device thrombosis after BVS implantation, the causes underlying thrombotic events occurring     beyond one year after scaffold implantation remain unclear and require investigation in an     independent manner.      The INVEST registry is a world-wide, multi-center, observational, retrospective,     investigator-initiated registry, which will include any patients who suffered from very late     (>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of     thrombosis and provided informed consent for the further use of their health related data for     this registry.   "
8018|NCT03180918|"     Background:      Due to the remarkable improvement in treatments these last decades, long term survival can be     expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can     be harmful to the gonads and can affect reproductive and endocrine functions. While loss of     fertility is a major concern for most patients, sperm cryopreservation should be offered to     all pubertal male patients. For prepubertal boys, only the experimental option of testicular     biopsy in order to cryopreserve testicular stem cells can be proposed.      Primary aims      - To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic     oncological treatment.      Secondary aims        -  To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal          patient with high risk of infertility        -  To create a database in order to record clinical and biological follow-up data        -  To create a research biobank for future research projects      Multicentric study: HUG, CHUV, UKBB   "
8019|NCT03180905|"     The researchers want to find out more about a standalone software application, ImPACT Online     and how it relates to other commonly used tests of memory, attention and reaction time.     ImPACT Online is a computer-based neurocognitive test for concussion management. The test was     designed to help measure the effects of concussion on cognitive processes (for example,     memory, attention, brain speed) and visual functioning.   "
8030|NCT03180762|"     The purpose of this study is to investigate the safety and tolerability of JNJ-64140284     versus placebo after single oral dose administration (ascending dose levels) under fasted     condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal     fluid (CSF) and urine after single oral dose administration and to investigate the effect of     food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose     administration.   "
8031|NCT03180749|"     Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm     Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers   "
43216|NCT02720003|"     To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion     of the superficial femoral and popliteal arteries.   "
8033|NCT03180723|"     Type I membranoproliferative glomerulonephritis (MPGN) is a relatively uncommon glomerular     disease, constituting 1.8% of renal biopsies performed in Rochester, minnesota, United States     of America, at the Mayo Clinic, between 1993 and 2008. The prognosis of idiopathic Type I     MPGN is relatively poor. Recently, Irish series, slightly more than 50% of patients developed     end stage renal disease after a mean follow up of 14 years . The disease may recur after     renal transplantation . High-dose glucocorticoids have been used to treat this disease in     children but there is no established treatment in adults.   "
8034|NCT03180710|"     This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using     automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.   "
8020|NCT03180892|"     Background: Autoimmune hypothyroidism has been regarded as the most common cause of primary     hypothyroidism in iodine sufficient area and has relationship with excess iodine induced     hypothyroidism. However, non-immune related hypothyroidism and its relationship with excess     iodine have been rarely evaluated.      Objective: Therefore, the investigators planned to calculate proportion of non-immune related     hypothyroidism and relationship with iodine intake using nationwide data from Korea National     Health and Nutrition Examination Survey (KNHANES) 2013-2015.      Design:        1. Korea National Health and Nutrition Examination Survey VI (2013 to 2015) - The national          data - which is the government designated statistics (Approval No. 117002 ) of South          Korea based on the Article 17 of the National Health Promotion Act - were used. The          survey was approved by the Institutional Review Board of the Korea Centers for Disease          Control and Prevention, and provides only non-identified measures for academic research          purposes.        2. The participants who were examined for thyroid stimulating hormone, free thyroxine,          thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC) were          included.        3. The proportion of immune related and non-immune related hypothyroidism was evaluated.          Demographic variables and severity of hypothyroidism were compared between the two          groups. To analyze iodine effect on hypothyroidism in TPO Ab positive or negative          population, prevalence of hypothyroidism were assessed in each TPO Ab negative and          positive population according to UIC subgroups.        4. This study protocol was approved by IRB of SMC (2017-05-149).   "
8021|NCT03180879|"     This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet     (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be     taken without water and can be used 'on the go'. Vanquish has an improved organoleptic     profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as     a suitable dosage form for children who may be reluctant to swallow tablets. This product has     the potential for application in both adults and children due to the convenience of the     format and the ease of administration for both groups.      This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.   "
8022|NCT03180866|"     This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of     a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive     dressing in adult subjects with mild to moderate psoriasis vulgaris. Two interpatient arms     will be used to compare the efficacy of combination of NBUVB with an occlusive dressing     (active) to no treatment (control). 32 patients will be enrolled in this 30 week study.   "
8023|NCT03180853|"     The purpose of this study is to document the participants characteristics, disease burden,     and clinical management of participants in the United States who are treated for relapsed     multiple myeloma in routine medical practice with a treatment strategies that include a     proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or     combination therapy with other treatments.   "
8024|NCT03180840|"     This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of     pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry     patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3     years. Safety and efficacy exploratory endpoints will be evaluated throughout the study     period and pharmacokinetics will be obtained on Day 1 and Week 52.   "
8025|NCT03180827|"     Background:      Due to the remarkable improvement in treatments these last decades, long term survival can be     expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can     be harmful to the gonads and can affect reproductive and endocrine functions. While loss of     fertility is a major concern for most patients, only the experimental option of ovarian     tissue cryopreservation can be proposed to prepubertal girls with a high risk of infertility.     For pubertal patient, cryopreservation of mature oocytes after ovarian stimulation can be     offered if oncological treatment debut can be delayed. As it is often not possible, ovarian     tissue cryopreservation can also be offered.      Primary aims      - To cryopreserve ovarian tissue of prepubertal and pubertal patient who will be receiving     highly gonadotoxic oncological treatment.      Secondary aims        -  To create a database in order to record clinical and biological follow-up data        -  To pool resources with Fertisave Registry        -  To create a research biobank for future research projects      Monocentric study: HUG   "
8026|NCT03180814|"     Aging causes anatomical and physiological changes in the cardiovascular system and autonomic     function with decline in its maximum function. This study aimed to evaluate the acute effects     of whole body vibration on cardiovascular system, autonomic function and heart variability in     healthy young and elderly. The investigators' hypothesis is that whole body vibration has     different effects in young and elderly.   "
8027|NCT03180801|"     FLU-v is a broad spectrum influenza vaccine that targets regions in the influenza virus that     are conserved among many different influenza strains.This study aims to assess efficacy of     FLU-v vaccine in protecting healthy FLU-v vaccinated volunteers against an influenza     challenge delivered intranasally under quarantine.      Efficacy of FLU-v will be assessed by measuring the incidence and severity of the disease in     the treatment groups compared to the placebo group. In addition, the immune responses of the     volunteers to FLU-v will also be explored.   "
8028|NCT03180788|"     The aim of this study is to evaluate the role of traction assisted ESD in comparison to     traditional ESD on procedural time and outcome in patients with large, non pedunculated     colorectal polyps.   "
8029|NCT03180775|"     Recently, the investigators have been screening for anti-atherogenic or pro-atherogenic amino     acids (AAs) in the macrophage model system to better understand their role in atherogenesis.     The findings so far suggest that specific AAs induce selective anti-atherogenic effects     (glycine, alanine, leucine and cysteine) or pro-atherogenic effects (glutamate and glutamine)     in macrophages. Taking together the above previous reports with the mechanisms behind     macrophage foam cell formation and atherogenesis, it is possible that AAs could be     anti-atherogenic or pro-atherogenic via their mechanism of action on macrophage foam cell     formation. This paradigm may serve as a basis for the development of novel cardio-protective,     anti-atherogenic nutritional, or therapeutic approaches, that should be studied in human     trials.   "
8032|NCT03180736|"     The purpose of this study is to evaluate the effects of the addition of daratumumab to     pomalidomide and dexamethasone in terms of progression-free survival in subjects with     relapsed or refractory Multiple Myeloma.   "
8035|NCT03180697|"     Targeted therapy with bevacizumab is the main method to prolong the progression-free survival     of patients with recurrent malignant gliomas in recent years. Using noninvasive imaging     methods to predict which RMG may respond to bevacizumab regimen therapy is a clinical problem     ; on the other hand, repeated gadolinium enhancement may increase the risk of gadolinium ion     deposition of brain tissue. Furthermore,there may be a false response phenomenon and cause     assessment bias.in the evaluation of treatment efficacy,owing to bevacizumab is only     anti-tumor angiogenesis.      Amide Proton Transfer (APT) is a new molecular imaging technique. Our previous studies have     shown that imaging features and signal changes of APT can fully reflect the therapeutic     effect of malignant glioma,without the injection of contrast agent and avoid the side     effects.      RMG patients will be recruited in this study . This project will be designed multi-center,     prospective, observational clinical research. The changes of APT signal intensity before and     after treatment will be compared with those of different types of RMG line. The relationship     between APT imaging characteristics and clinical end point events will be investigated and     compared with conventional MR imaging technique. The sensitivity, specificity and accuracy of     the progression-free survival and median overall survival will be measured after treatment     with bevacizumab.   "
8037|NCT03180671|"     The study will be conducted in four groups of 20 patients in age of 20-30 years with complete     dentition or single tooth loss in lateral regions, with masticatory muscle pain in the     history or during examination and overuse and/or chronic tensing of the masticatory muscles.     Patients will be randomly assigned to the groups.      Each person will be measured twice before and after use of selected anterior deprogrammer.     The following assessment tools will be applied:        -  surface electromyography of masseter and temporal muscles,        -  intraoral pin-supported registration to draw a gothic arch.      Measurements will be made before and after intervention to assess the effect of anterior     deprogrammer application on the tone of the selected masticatory muscles and condyles     position in mandibular fossa. The first group (control) will be counsel with an explanation     of the pathomechanism of masticatory muscles pain and preventive principles. In the second     group, the Sliding Guide will be used for a period of 12-15 minutes, in the third Dawson     B-Splint for 7 days, and in the fourth Kois deprogrammer for 14 days. Devices in group 3 and     4 will be used by patients for 24 hours a day, with breaks for oral hygiene procedures and     eating/drinking.      The aim of the study is to evaluate the effectiveness of selected anterior deprogrammers.   "
8038|NCT03180658|"     Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth     factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human     mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars     will be included and randomly divided into two groups. The experimental group will accept GTR     + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The     clinical examination and cone beam computed tomography (CBCT) will be performed at baseline     and 1 year post-surgery.   "
8039|NCT03180645|"     The objective of this POC clinical study is to evaluate the moisturising effects on fine     lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks     of twice daily application of the test product on participants presenting visible signs of     ageing.   "
8040|NCT03180632|"     The purpose of this study is to determine the effect of a single dose of Lorazepam on     salivary cortisol in children undergoing digestive endoscopy. To do so, the patients will be     randomized in three groups. The first group receives the Lorazepam, the second group receives     a placebo and the last group receives no intervention. Each patient will have three saliva     samples taken at three different time point on the day of the endoscopy and will be asked to     fill out questionnaires on anxiety and overall satisfaction of the procedure.   "
8041|NCT03180619|"     The primary objective of this study is to evaluate the safety and tolerability of tenofovir     alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal     and/or hepatic impairment.      This study consists of 2 Parts. Approximately 90 renally impaired participants will be     enrolled in Part A and approximately 30 hepatically impaired participants will be enrolled in     Part B.   "
8042|NCT03180606|"     The present health care situation for the elderly in many countries is insufficient and not     designed according to the health care needs of the aged population. In a pragmatic     multicenter primary care setting (n= 1600), the investigators use an evidence based     prediction model to find elderly (75+) with high risk for complex medical care or     hospitalization and apply a differentiated and directed medical and social care to this risk     group, in comparison to usual care. The intervention will include all the latest evidence     based tools in the care of elderly (multi-professional team, social support, medical care     home-visits, telephone support, general practitioner visits, etc). The project has high     potential impact on the development of future care of elderly.      In addition to the intervention study, several academic sub-studies focusing on patient's     perspective, professional roles, equality, implementation and governance management of health     care will be performed.   "
8043|NCT03180593|"     To assess the efficacy of Left Ventricular Hypertrophy (LVH) reduction and 24-hour blood     pressure control of Valsartan 80mg or Nebivolol/Valsartan 5/80mg once daily as replacement     therapy for currently treated or untreated hypertensive patients with LVH not at BP goal.   "
8056|NCT03180424|"     This study evaluates the impact of the treatment with L-Carnitine on the function of adults     over 65 years, in conjunction with regular exercise. Simple randomization will be performed,     distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical     exercise at home or supervised.   "
8057|NCT03180411|"     The goal of this research study to help develop a tool to assist patients in making decisions     about care during treatment for colorectal cancer. Information collected during this study     will be saved to help develop future studies about patient decision making in cancer     treatment.   "
8058|NCT03180398|"     This is a pilot study of implement multi-parametric MR imaging for organ delineation and     tumor response assessment of prostate cancer patients being treated with radiation therapy.     The study aims to generate intraprostatic lesions maps based on imaging, perform the     treatment planning to compute the highest feasible simultaneous boosting dose to     intraprostatic lesion and characterize longitudinal changes in imaging characteristics.   "
8044|NCT03180580|"     In Bangladesh, the prevalence of overweight and obesity among children varies from less than     1% to 17.9% based on different reference standard. In 2014 school based country wide study     has been demonstrated that among children (6-15 years of age), 9.6% were overweight and 3.5%     children were obese. Childhood obesity is getting increasing attention due to its association     with adult obesity and increased risk of co morbidities in adulthood. Childhood obesity is     known to be an independent risk factor for adult obesity and once a child is obese, it is     difficult to reverse through interventions. This suggests an urgent need to address     overweight and obesity levels in childhood. The increasing trend of childhood obesity     suggests urgent solution of the problem. There is no evidence of intervention for childhood     overweight and obesity exists in Bangladesh. This feasibility study will be able to generate     evidence for overcoming this upcoming epidemic in resource poor setting. If the proposed     study will be able to address its objective that will create a possibility for developing a     large cluster randomized trial in low resource setting like Bangladesh. This study will also     give opportunity to our policy makers for advocating to the government of Bangladesh for     adopting an obesity control policy for children.      The aim of the study is to develop a school based healthy eating and active lifestyles module     and assess feasibility and acceptability of the guideline in school setting.      Outcome measures/variables:      Healthy Eating and Active Living intervention material (Guideline, Tiffin box) Perception of     children, parents and policy makers regarding obesogenic behavior Acceptance of children,     parents and policy makers regarding planned intervention.      Facilitators and barriers of Healthy Eating and Active Living.   "
8045|NCT03180567|"     As drug response is a complex trait in the majority of cases using an optimal starting dose     for an individual may reduce the time taken to reach a stable INR, and reduce the risk of     having either a high INR (with a risk of bleeding) or a low INR (with a risk of thrombosis)   "
8046|NCT03180554|"     Chronic widespread pain (CWP) is considered one of the most common and costly health     conditions today. Due to its complex aetiology, both psychopharmacological and psychosocial     treatments have been struggling to lower pain intensity and disability in patients suffering     from CWP. However, recent research has found that there is a strong association between low     parasympathetic nervous system (PNS) activity and pain intensity in patients diagnosed with     CWP. Furthermore, research has suggested that increasing PNS activity by stimulating the     vagus nerve may lower pain intensity in patients with CWP. This present study will     investigate and compare the effects of non-invasive transcutaneous vagal nerve stimulation     (tVNS) and deep breathing (DB) on low PNS activity in patients with CWP. We hypothesise that     by stimulating the vagal nerve, either exogenously with tVNS or endogenously with DB, we will     increase PNS activity and therefore decrease pain intensity, disability, and increase both     psycho and physiological wellbeing in patients suffering from CWP.   "
8047|NCT03180541|"     This study aims to evaluate the coordinated implementation of Dialectical Behaviour Therapy     in Community Mental Health Services in Ireland.      There are three main objectives of the current study:        -  evaluate the effectiveness of DBT for adults and adolescents attending Community Mental          Health Services in multiple sites across Ireland        -  conduct an economic evaluation of the coordinated implementation of DBT in community          settings in Ireland        -  evaluate the implementation initiative by means of quantity, quality and experience of          the coordinated implementation   "
8048|NCT03180528|"     This phase II trial studies how well remetinostat works in treating patients with skin basal     cell cancer. Remetinostat may slow the growth of basal cell cancer cells.   "
8049|NCT03180515|"     Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs     in Parkinson's disease, however some patients find that it does not adequately treat their     freezing of gait (FOG). Currently, cDBS is limited to open-loop stimulation,without     real-time adjustment to the patient's state of activity, fluctuations and types of motor     symptoms, medication dosages, or neural markers of the disease. The purpose of this study is     to determine if an adaptive DBS system,responding to patient specific, clinically relevant     neural or kinematic feedback related to FOG, is more effective than continuous DBS on the     motor Unified Parkinson's Disease Rating Scale (UPDRS III) and gait measures of PD.   "
8050|NCT03180502|"     This randomized phase II clinical trial studies the side effects and how well proton beam or     intensity-modulated radiation therapy works in preserving brain function in patients with IDH     mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to     deliver radiation directly to the tumor and may cause less damage to normal tissue.     Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to     treat the tumor and may also cause less damage to normal tissue. Patients will be more likely     to be randomized to proton beam radiation therapy. It is not yet known if proton beam     radiation therapy is more effective than photon-based beam intensity-modulated radiation     therapy in treating patients with glioma.   "
8051|NCT03180489|"     Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose     co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose     co-transporter 2 inhibitors is associated with moderate weight (fat) loss, in addition to     other health benefits, including decreased blood pressure, decreased inflammation, and     decreased oxidative stress. It is unclear as to whether these health benefits are due to     SGLT2 inhibition per se, or as a secondary effect of weight loss. We wish to compare the     health benefits of dietary counseling for weight loss with and without concomitant use of an     SGLT2 inhibitor.   "
8052|NCT03180476|"     The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for     Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free     survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug     safety.   "
8053|NCT03180463|"     The purposes of the study is to evaluate the safety and efficacy of human umbilical cord     mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.   "
8054|NCT03180450|"     The purposes of the study is to evaluate the safety and efficacy of human umbilical cord     mesenchymal stem cells (hUC-MSC) in treating heart failure patients   "
8055|NCT03180437|"     In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor     reducing surgery, for example cryosurgery going to be investigated.   "
8059|NCT03180385|"     Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which     comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA)     and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive     alternatives to providing respiratory support post-operatively. The investigators hypothesize     that providing synchronized biphasic support with NAVA will be associated with shorter     duration of non-invasive respiratory support, less sedation requirements, and reduced length     of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive     either NAVA or BiPAP following their cardiothoracic surgery.   "
8060|NCT03180372|"     This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid     fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.   "
8061|NCT03180359|"     Thanks to improved surgical techniques, postoperative management and immunosuppressive     therapies, an increasing number of children benefit from renal, hepatic, cardiac and     pulmonary transplantation. Infection is a significant cause of mortality and morbidity in     these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the     effective means of reducing infection-related mortality in these particularly vulnerable     children. It is mostly well-tolerated, but all the more effective as it is performed early     before transplantation, at best during a dedicated consultation, according to a vaccine     scheme adapted to the immunocompromised child. In the almost constant absence of clinical     efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often     indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation     in immunocompetent individuals.      Primary objective: To estimate the immunogenicity of vaccines recommended in children     transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using     serological titers measurements before and after a vaccine injection for: influenza,     pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B.      These serological titers will be compared to correlates of protection existing for each     valency.      The evolution of serological titers will be described during the first year. The vaccination     will be carried out within the routine care, according to the recommendations.      Secondary objectives:        -  describe and quantify the vaccination status of patients        -  describe the vaccination coverage of their entourage        -  evaluate the tolerance and efficacy of vaccines   "
8062|NCT03180346|"     The primary aim of this study is to determine if the SSI rate following revision total hip     and knee arthroplasty is reduced in patients treated with the PICO device compared to     patients with traditional postoperative dressings. Our secondary goals include; comparing the     amount of wound drainage, rate of resolution of wound drainage, length of hospital stay,     functional outcomes, and economic implications of wound drainage and SSI after revision     arthroplasty comparing PICO and traditional dressings.   "
8063|NCT03180333|"     Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of     multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug     concentration in the plasma and urine after a single oral administration of different doses     of PNA on the condition of fasting, the pharmacokinetic parameters of the single dose are     estimated;3.By measuring the changing drug concentration in the plasma of PNA after a     multiple-dose oral administration on the condition of fasting, the pharmacokinetic parameters     of multiple-dose are estimated, and a basis for dosage regimens of the clinical research     phase Ⅱ is provided;4.To study the effects of diet on the pharmacokinetic parameters via the     changes of concentration of PNA in plasma after high-fat and high-calorie food.   "
8064|NCT03180320|"     Chronic heart failure (CHF) is a major and growing public health problem and poses economic     burden on the society. There is a need for a safe, equipment-free, low-cost, and easily     implemented exercise-based cardiac rehabilitation program for CHF patients in China.     Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms     of traditional Chinese exercise and it could have value to be integrated into a     exercise-based cardiac rehabilitation program for CHF patients, together with education,     evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin     exercise as the central component, has been developed in Guangdong Provincial Hospital of     Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This     project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with     CHF in China, and it will be based on a randomized controlled trial and a qualitative study.   "
8065|NCT03180307|"     This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in     patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to     undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer     surgery.   "
8066|NCT03180294|"     This phase II randomized trial studies how well bupropion hydrochloride works in improving     sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work     by boosting sexual desire, energy, or motivation without causing intolerable or undesirable     side effects.   "
8077|NCT03180151|"     -  To compare patients who will undergo orthodontics treatment involving upper premolar          extraction for space of time whether with or without corticotomy by Piezotome.        -  Assess the safety of both methods of retraction in regard to the quality of the          surrounding periodontium and roots of anterior teeth.        -  Monitor postoperative pain.   "
8087|NCT03180021|"     To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI),     blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast     enhanced magnetic resonance imaging (DCE-MRI) to evaluate the intra-renal blood flow,     perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus     nephritis (LN) and compare these parameters to renal biopsy findings to determine whether     DWI, BOLD, T1rho, and DCE-MRI may provide a set of non-invasive tools to assess renal     function and pathology in LN.   "
8088|NCT03180008|"     This randomized controlled trial is comparing outcomes of customary Fit and Strong!, to Fit     and Strong! Plus, an enhanced version of the program that incorporates weight management. We     hypothesize that Fit and Strong! Plus participants will show improved diet behaviors at 2, 6,     12, and 18 months that will be accompanied by a significant 5% weight loss at 6 months and     maintained to 18 months, compared to participants in customary Fit and Strong!.   "
8067|NCT03180281|"     Prevalence of diabetes is increasing rapidly both in China and all over the     world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and     cerebrovascular diseases and even dangerous to human health.High glucose toxicity cause     pancreatic β cell non-physiologic and irreversible damage.It is an important cause of β cell     dysfunction.High glucose toxicity further suppresses insulin secretion of β cell, further     even β-cell function failure.It is urgent to explore more effective and safety treatments     which can also protect islet cells function.How to release high glucose toxicity , reverse     the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize     recover and protect the pancreatic β cell function is the keypoints of this study.Our aim is     to explore the non-inferiority of new antidiabetic drugs DPP4 inhibitors on releasing glucose     toxicity and protecting islet β cell function compared with traditional treatments on newly     diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs     and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and     compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic     β-cell function.   "
8068|NCT03180268|"     This randomized phase III trial studies how well radiation therapy works compared with     observation in treating patients with newly diagnosed grade II meningioma that has been     completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells     and shrink tumors.   "
8069|NCT03180255|"     Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the     EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with     implantation of a monofocal posterior chamber intraocular lens (IOL).   "
8070|NCT03180242|"     The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014     (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1:     Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States     (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after     intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel     groups of healthy male subjects.   "
8071|NCT03180229|"     Propofol is one of the most commonly used anesthetic agents because of its ability to induce     rapid and reliable collection. However, hypotension and injection pain in the induction are     the most common complications. After induction of propofol; The cardiovascular system     depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic     vascular resistance. This may also contribute to the reduction of sympathetic tone activity     in the central way, and slight reduction in the number of pulses that develop as a result of     increasing vagal activity. İn order to attenuate these hemodynamic undesired effects caused     by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer     lactate, ketamine. Ondansetron and granisetron, which are used for postoperative nausea and     vomiting prophylaxis, have been used as such. Therefore, ondansetron and granisetron were     preventing hypotension induced by post-spinal and general anesthesia induction.      The investigator also tried to demonstrate the effect of granisetron, another serotonin type     3 (5-HT3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction     hypotension and intubation quality before propofol induction in this study   "
8072|NCT03180216|"     This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated     multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus,     HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT     donors.      In this trial, the investigators will utilize a rapid generation protocol for broad spectrum     multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell     transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV and/or     HPIV3, or with PCR/culture confirmed infection(s). These cells will be derived from HSCT     donors, and the study agent will be assessed at each dose for evidence of dose-limiting     toxicities (DLT).      This study will have two arms: Arm A will include patients who receive prophylactic     treatment, and Arm B will include patients who receive VSTs for one or more active infections     with targeted viruses. Determination of the study arm will be determined by the patient's     clinical status. Study arms will each be analyzed for safety endpoints and secondary     endpoints.   "
8073|NCT03180203|"     The aim of this study is to investigate whether postoperative ventilation with     INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic     surgery, is as effective, more user-friendly and as safe as compared to the conventional     modes of ventilation.   "
8074|NCT03180190|"     Hydroxychloroquine(HCQ)play major role in management of many rheumatic diseases.      Retinal toxicity from HCQ is serious side effect because even after the drug drug is     discontinued, there is little if any visual recovery. For this reason, regular screening for     retinal toxicity is recommended to detect early retinopathy and discontinue the therapy.      Cytochrome P450 (CYP) enzymes play major roles in drug metabolism. Certain single-nucleotide     polymorphisms(SNPs) in CYP genes may have a large impact on CYP enzyme activity.Polymorphisms     in the cytochrome P450 gene might influence blood concentration some patients have a genetic     predisposition to HCQ toxicity (e.g.,from abnormalities in the ABCA4 gene)Which is not     studied previously among Egyptian population   "
8075|NCT03180177|"     This project is a multi-center, prospective, randomized controlled clinical observation the     safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant     chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for     advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking     surgery and 3-year disease-free survival is the primary end points of this project.   "
8076|NCT03180164|"     Chronic airways diseases involve alterations in the person's social roles, relationships and     self-perception so demands continual psychological adjustment .      Also Kunik studied patients with chronic breathing disorders for depression and anxiety and     found that 65% of patients were positive for depression and anxiety.      Shackell found that patients' anxiety and fears of breathlessness and dying extended into the     night and were aggravated by feelings of isolation and frustration. One patient reported that     they often thought 'am I going to see the next morning?'   "
10092|NCT03153852|"     Melasma is a common acquired disorder of hyperpigmentation characterized by irregular light     brown to dark brown patches of hyperpigmentation commonly affecting the face. The trunk and     arms are also occasionally involved .   "
8078|NCT03180138|"     Despite the impressive economic progress in developing countries, significant proportion of     young children and pregnant women living in low-resource settings remain inadequately     immunized. Progressive decline in immunizations are in large part attributable to poor     follow-up and compliance. National and international pediatric bodies, recommend a time     sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle,     leading to adequate levels of immune protection. Due to inadequate protective immunity,     resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are     rampant, making childhood mortality in this group among the highest in the world. Major     challenges of vaccination programs include maintaining / tracking records, linked to positive     identification of individual children, and strategies to improve follow-up and compliance.     Novel cellular technology based approaches targeting behavior modifications can therefore     significantly impact health outcomes in these communities. In this proposal, the     investigators will evaluate a novel software platform, utilizing biometric identification of     subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake     and coverage of primary vaccinations in young children and pregnant women.   "
8079|NCT03180125|"     carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper     extremities, CTS is characterized by typical anatomic changes, the most probable swelling of     the median nerve in the proximal part of the CT.      Local infiltration of corticosteroids easily leads to atrophy of the median nerve,     subcutaneous fat, and systematic complications, surgical treatment decision is always taken     by the patient who sometimes wants to delay or avoid the surgery because of psychological or     medical concerns, It would be interesting if low molecular weight sodium hyaluorinate     injection is used as an alternative conservative treatment of CTS. This study aims to     investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection     of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone     acetonide, under ultrasound guidance.   "
8080|NCT03180112|"     Autism spectrum disorders are pervasive developmental disorders that include autistic     disorder, Asperger's disorder, and pervasive developmental disorder-not otherwise     specified.They are characterized by stereotypic behaviors, variable deficits in language and     social skills and a wide range of other behavioral problems. Autism spectrum disorders     manifest during childhood and at least thirty percent present with sudden clinical regression     of development around three years of age.   "
8081|NCT03180099|"     Objectives:Lomber disc hernia is one of the most common diseases in Turkey. The prevalence in     various studies is between 60-80% and incidence is between 1-3% for the entire     population,Goal of TLIP is to provide a same impact in the thoracolumbar region, like     thoracoabdominal plane block (TAP) diminish the pain in the abdominal surgery Methods: The     study design was approved by the locale ethics committee. This double-blinded, randomized,     controlled clinical trial recruited 50 patients who were candidated for surgical operations     on lumbar disc hernia surgery. . Patients will be divided into two groups as Group T (TLIP     block) and Group E (Epidural group).In group T, TLIP block will be applied before anesthesia     and surgery and evaluate block efficiency with temperature discrimination and pin-prick test.     During the TLIP block, block fluid will have total volume of 20 mL of 0.5% bupivacaine.). In     Group E, after surgery, total of 20 ml of 0.1% bupivacaine and 50 mcg of fentanyl will be     performed in the epidural space with direct vision by the surgeon.For the postoperative     analgesia, patient controlled analgesia device will be administered as 20 mg/h continue dose     tramadol and administered 10 mg bolus dose tramadol if patient need a rescue dose.     Nausea-vomiting, tramadol consumption, bolus dose intervention and visual analog scale value     in the postoperative 0-4., 4-12., and 12-24. hour interval will be assess and results will be     record.   "
8082|NCT03180086|"     In a randomized controlled trial, the investigators will test the effect of a novel strategy     for breast cancer risk assessment and risk-based management of women in their 40s seen in     primary care. The investigators anticipate that this approach will lead to more optimal use     of mammography screening and breast cancer prevention interventions in women in their 40s and     as a result will improve care of these women.   "
8083|NCT03180073|"     Most of the conduction abnormalities with TAVR are usually detected during the procedure or     during the following days of observation. Little is known about the prevalence and timing of     any conduction abnormalities that exist before (other than standard ECG) or after through     long term cardiac monitoring.   "
8084|NCT03180060|"     Background: Detection of coronary artery disease (CAD) is important due to its high     prevalence and its medical and economic implications. Purpose: A systematic review of the     diagnostic performance of stress echocardiography (Echo), SPECT, cardiac magnetic resonance     (CMR), CT Perfusion (CTP) and PET versus invasive coronary angiography (ICA) or fractional     flow reserve (FFR) using hierarchical summary ROC (HSROC) methods. Data Sources: MEDLINE,     EMBASE and SCOPUS for literature published in English or Spanish from January 1970 to     December 2015. Study Selection: For inclusion, studies had to meet the Cochrane guidelines,     had to evaluate the sensitivity and specificity methods, and use ICA and/or FFR. Only those     studies with STARD methodology ≥60% were included. Data Extraction: Ten investigators     extracted patient and study characteristics and 4 resolved any disagreements.   "
8085|NCT03180047|"     This study characterizes acute dry eye symptom control, assessed during exposure to a     Controlled Adverse Environment, following use of the TrueTear for 45 days.   "
8097|NCT03179891|"     The hypothesis of this study is that DBSF will be safe whether it is given when subjects are     not experiencing seizures (Interictal Period A) or experiencing active seizures     (ictal/peri-ictal Period B), and that Pharmacokinetic (PK) is not different during or in     between the seizures.   "
8098|NCT03179878|"     A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized,     Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate     Safety, Tolerability, Dosing, and Pharmacodynamics   "
8122|NCT03179566|"     Patients will be randomized to one of two interventions intended to facilitate safe disposal     of opioids after cessation following surgery. For pragmatic reasons, participants will be     randomized by day to either the information sheet or the disposal bag using a block     randomization schedule. To ensuring adequate sample size, patients will be enrolled for a     ~4-week period following the 2-week usual care run in period. In the event that the sample     size estimate has not been reached after the 4-week intervention period, additional patients     will be enrolled accordingly.   "
8089|NCT03179995|"     This will be a prospective, randomized, double blind trial enrolling patients who will     undergo major liver resection. Patients will be randomized in a 1:1 ratio to receive either     octreotide or placebo in the postoperative period. The patients will receive octreotide     intravenously continuously for five days after operation. During this period the patients'     health will be monitored by performing blood tests including complete metabolic profile,     Complete Blood Count (CBC) with/diff., INR and PTT. The functioning of heart will also be     monitored post-operatively by EKG. Up to 80 participants will be accrued over a 2 year     period. Volumetric CT scans will be performed prior to hepatectomy, 1 week after hepatectomy     and 3 months after hepatectomy to evaluate liver regeneration.   "
8090|NCT03179982|"     The purpose of this study is to test the feasibility and acceptability of Safe South Africa,     an integrated intervention for preventing HIV and Intimate Partner Violence perpetration for     male adolescents 15-17 years of age.   "
8091|NCT03179969|"     In approximately 10-15% of all patients after surgical or interventional heart valve     replacement, flapping defects appear as complications in the long-term course, so-called     paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the     defect, a new procedure is required - with a not inconsiderable disease or even mortality     risk   "
8092|NCT03179956|"     A window of opportunity study which would allow brief treatment of HPV negative SCCHN with a     CDK4/6 inhibitor, in the pre-operative setting, with biomarker analyses of pre and post     treatment tissue. Given that the standard treatment for this population is surgical     resection, this would not impact or alter standard therapy for this population. The goal will     be to learn more about the alterations in pRB1 levels, as well as other signaling markers, in     order to be able to eventually plan a biomarker driven treatment study.   "
8093|NCT03179943|"     This is a single arm Phase II study with a safety run-in to identify the recommended phase II     dose of the combination therapy of atezolizumab and guadecitabine. Patients with     recurrent/advanced urothelial carcinoma (stage IV) who had previously progressed on     check-point inhibitor therapy with PD-1 or PD-L1 targeting agents are eligible for this     study. After a dose that is safe and tolerable has been established, a dose expansion phase     (Phase II) will begin. This study will enroll a total of 4 to 53 patients depending upon the     number of patients treated in the safety run-in phase and the number of subjects replaced     during the phase II portion.   "
8094|NCT03179930|"     The purpose of this study is to test any good and bad effects of the study drugs called     Pembrolizumab and Entinostat when used in combination to treat lymphoma. This combination     could shrink the lymphoma but it could also cause side effects. Researchers also hope to     learn whether adding entinostat to pembrolizumab can be more effective for patients with     lymphoma than either drug alone.   "
8095|NCT03179917|"     This study is being done to test the safety and effectiveness of pembrolizumab followed by     radiation therapy in Hodgkin lymphoma.      The purpose of this study is to determine how effective combining the research drug,     pembrolizumab, with a targeted form of radiation therapy known as involved site radiotherapy     can be in patients with relapsed or refractory early stage classical Hodgkin lymphoma. The     goal is to see whether this treatment strategy can cure a significant number of patients with     relapsed or refractory early stage classical Hodgkin lymphoma while avoiding the toxicity of     either a large radiation field or further chemotherapy and stem cell transplant.   "
8096|NCT03179904|"     This phase II trial studies how well FASN inhibitor TVB-2640, paclitaxel, and trastuzumab     work in treating patients with HER2 positive breast cancer that has spread to other places in     the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and     trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving FASN     inhibitor TVB-2640, paclitaxel, and trastuzumab may work better in treating patients with     HER2 positive breast cancer.   "
8099|NCT03179865|"     Establishing that mucosal healing (MH) has occurred after therapy is an important treatment     goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical     parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has     demonstrated good correlations for clinical remission and disease severity, but its role for     establishing mucosal healing after therapy has not been validated . The ability to predict     mucosal healing may be different for patients in long term remission compared to assessment     after obtaining clinical remission. No previous study has prospectively validated the use of     PUCAI as a proxy for MH specifically during clinical remission after therapy.   "
8100|NCT03179852|"     The primary objective is to assess pre- and post-intervention nutrition education knowledge     and preference. The secondary objective is to assess pre- and post-intervention fruit and     vegetable consumption via a plate waste study.   "
8101|NCT03179839|"     The primary objective of the study is to evaluate the clinical curative effect of MBCT to     reduce obsessive and compulsive symptoms. Moreover, the investigators will also explore a     MBCT manual for Chinese patients with OCD, which can be widely applied to the clinical     practice.      There are two parts of the study. The first part is a qualitative research with two pilot     MBCT groups. The second part of this study is a single-blind randomized controlled trial with     three study arms: one - third of participants receive group mindfulness-based cognitive     therapy led by trained MBCT psychotherapists or psychiatrists in addition to medication, one     - third of participants receive group psycho-education program and one - third of     participants receive drug therapy as usual. All participants have 10 sessions intervention     and assessments.   "
8131|NCT03179449|"     This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance     imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with     malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a     noninvasive imaging biomarker of inflammation.   "
8132|NCT03179436|"     This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary     efficacy of escalating doses of MK-1308 when used in combination with pembrolizumab in     participants with advanced solid tumors.   "
10230|NCT03152045|"     The purpose of this pilot study is to evaluate the feasibility, acceptability, and     preliminary efficacy of an intervention aimed at improving how adolescent patients and their     clinicians communicate about behavior change.   "
8102|NCT03179826|"     Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling     pathologies. The general practitioner is often at the front line vis-a-vis screening,     diagnosis and treatment of these pathologies. There are currently many treatments available,     in particular inhaled corticosteroids, and although the recommendations for management appear     to be well codified in theory, the adaptation of drug therapy remains complex in general     practice.      The prescription of inhaled corticosteroids, often initiated during a general medicine     consultation, is not simple. The aim of this study is to analyze the relevance of the     prescription of inhaled corticosteroids in primary care and to identify the criteria     necessary for the prescription of inhaled corticosteroids available in general practice.      The main objective of our study is to evaluate the rate of consultations where all the     elements required for guiding the prescription of an inhaled corticoid are available.      The secondary objectives are:        -  Identify other factors associated with decision-making        -  Identify the causes of inhaled corticosteroid stopping (de-prescription)   "
8103|NCT03179813|"     The investigators set out to develop a clinical trial in order to test the topical use of     hydrocortisone as a intraoperative irrigant solution. As this route of administration as well     as being low cost and not add new steps to the surgical procedure, can contribute to an     improved quality of life in the postoperative period of patients undergoing extraction of     third molars.   "
8104|NCT03179800|"     The objective of this study is to evaluate the safety and effectiveness of the MobiusHD     System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal     study.   "
8105|NCT03179787|"     The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in     patients with autism in the real world clinical setting in Japan.   "
8106|NCT03179774|"     Revascularization for carotid artery occlusion (CAO) remained controversial, there is no     prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO     patients. The investigators conduct a prospective study composed of clinical registry arm and     RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and     thereafter up to 12 months.   "
8107|NCT03179761|"     This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or     standard-dose quadrivalent inactivated influenza and how well they work in treating adult     patients undergoing stem cell transplant. Season influenza can cause more severe infections     in patients who have had a stem cell transplant since their immune system doesn't work as     well. Influenza vaccine may provide better protection against flu in adults.   "
8108|NCT03179748|"     The trial is conducted in North America. The aim of the trial is to assess the safety of     turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in     Mexico   "
8109|NCT03179735|"     The number of orthodontic treatment provided to Brazilian population has been increased.     Unfortunately, some negative effects such as gum bleeding and bad breath are commonly     observed. It partially happens because tooth brushing and flossing become more difficult in     the presence of braces. Therefore, there is a need for clinical protocols able to maintain     the mouth healthy during orthodontic treatment.      Considering that proper use of mouthwashes by in individuals without braces is accompanied by     decrease in plaque and gum inflammation levels, it was hypothesized that, during orthodontic     treatment their anti-gingivitis and anti-plaque properties would positively affect oral     health. Objectives: The present study will compare the effects of two commercially available     mouthwashes with a placebo mouthwash in orthodontic patients wearing fixed appliances.      Whole-mouth clinical examinations will be performed in periodontally healthy patients 15 days     before, at the day of bonding and also 3 and 6 months after braces bonding. Hard and soft     tissues status, presence of gingivitis and amount of dental plaque will be monitored to     determine mouthwashes efficacy. At these same time-points plaque samples will be collected     from dental sites and braces surfaces aiming at determining total levels of bacteria and     levels of specific bacteria related to gum disease. After a full-mouth ultrasonic debridement     to remove dental plaque, stains and tartar, patients will be randomly assigned to an     Essential oils, Cetylpyridinium chloride or a placebo mouthwash for 6 months (40 ml/day).     Further, samples of orthodontic wires will be analyzed under microscopy to check whether     regular use of mouthwashes increases the risk of corrosion or not.   "
8121|NCT03179579|"     This project is a multi-center, prospective, randomized controlled clinical observation the     safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients     accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and     systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as     the research object, with median progression-free survival and overall survival, adverse     events as the end points.   "
8110|NCT03179722|"     In this intervention study, 75 Belgian community pharmacies each recruit 12 patients for an     intermediate medication review. For each patient, the identified drug-related problems and     subsequent interventions are registered using the PharmDisc classification. In a subset of     Dutch speaking patients, a pretest-posttest single group design is used to measure the impact     of this review on patient related outcomes using questionnaires. The primary outcome is the     medication related quality of life, measured via the living with medicines questionnaire.     Other patient reported outcomes include adherence, self-management, patient satisfaction,     fall incidents and use of emergency healthcare services. Medication records are also     collected to objectively measure adherence before and after the intervention.   "
8111|NCT03179709|"     The proposed study will use qualitative methodology to understand health care provider     perceptions of neuromuscular blockade (NMB) in patients with Acute Respiratory Distress     Syndrome (ARDS). To achieve this goal the investigators will conduct a prospective ancillary     study at four clinical centers participating in the NHLBI PETAL network as part of the ROSE     (Reevaluation of Systemic Early Neuromuscular Blockade) clinical trial (NCT02509078). Using     thematic content analysis of semistructured interviews with health care providers caring for     patients enrolled in the ROSE trial the investigators will determine the barriers to NMB use     and develop a framework for future NMB adoption in ARDS.   "
8112|NCT03179696|"     This clinical trial will test a combined group therapy plus mobile cognitive behavioral     therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order     to change motivational negative symptoms linked to defeatist attitudes.   "
8113|NCT03179683|"     This randomized controlled split-mouth clinical trial study was designed to evaluate the     effects of low-level laser therapy on bone healing in patients with bilateral sinus lifting     and simultaneous dental implant application.      Maxillary posterior partially edentulous or totally edentulous twelve patients who need     bilateral sinus bone augmentation were included in this study. Sinus bone augmentation and     dental implant surgeries were done simultaneously. Low level laser therapy (LLLT) was (λ=     630-660 nm, 25 mw / cm², 6 mins) applied for just one operation side at first, third, fifth     and seventh days. Treatment side were randomly selected by another surgeon who applied LLLT.     Panoramic radiographs were taken at the first, third and sixth months using aluminum     step-wedge technique. Optic Density analyses were performed using Cardinal Health Digital     Densitometer (Fluke Biomedical 07-443) with 1mm diameter. Digital densitometric results were     obtained as equivalent aluminum thickness for each radiograph. These data were used to     evaluate changes in optical bone densitometry and compare the LLLT applied side and control     side for each patient.   "
8114|NCT03179670|"     The high level of unsatisfactory outcome observed in patients treated for LUTS associated     with BPH with respect to the different existing therapeutic options strongly emphasizes the     need for treatment optimisation in daily practice by a careful LUTS monitoring and treatment     adjustment when needed. The poorer outcome observed in patients for whom treatment has been     initiated recently suggests that the duration of the disease itself may influence the patient     satisfaction.To achieve this goal, we propose to systematically assess LUTS associated with     BPH in patients treated for at least 6 months and to assess whether an alpha-blocker therapy     initiation/modification may improve the outcome in case of persisting symptoms. We also     investigate the influence of the symptom duration on the frequency of unsatisfactory outcome.   "
8115|NCT03179657|"     Purpose: The Guangzhou Nutrition and Health Study (GNHS) aims to assess the determinants of     risk of osteoporosis and cardio-metabolic diseases and changes in their relevant indices in     nutritional aspects, as well as other environmental and genetic factors.      Study design: GNHS is a community-based prospective cohort study.      Participants: About 4540 apparently healthy residents, living in Guangzhou city (South China)     for >5 years, aged 40-80 years, recruited between 2008 and 2013.      Visits and Data Collection: Participants were/will be visited every three years by invited to     the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews,     specimen collection, anthropometric measurements, DXA scanning, ultrasonography evaluation     were/will be conducted. Up to May 2017, 3400 and 2380 subjects completed the 2nd and 3rd     visits.      Key variables:        1. Questionnaire interviews: Structured questionnaires were/will be used to collect the          participants' socio-demographic characteristics, lifestyle factors, menstruation and          reproductive history (women only), sleep quality, family history, psychological health,          social support and participation, cognitive function, habitual dietary intake, use of          supplements and history of chronic diseases.        2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip          strength, and usual gait speed.        3. DXA scanning: A dual-energy x-ray absorptiometry (DXA) was/will be used to determine          bone density and bone mineral content, bone geometry information, fat mass and muscle          mass.        4. Ultrasonography evaluations: Ultrasonography evaluation was/will be performed to          determine carotid artery intima-media thickness and plaque, and fatty liver.        5. Specimen collections: Overnight fasting blood sample and early morning first-void urine          sample and faces samples were/will be collected, separated and stored at −80°C till          tests.        6. Laboratory tests:             1. Blood tests: Metabolic syndrome-related indices; inflammatory markers; sexual               hormones and SHBG; genetic markers; nutritional indices (e.g., carotenoids; fatty               acids; minerals, folate, betaine, choline, and vitamin D, etc.)             2. Urinary tests: Flavonoids and flavones; minerals; creatinine and renal function               related markers             3. Fecal test: Gut microbiota and related metabolites.        7. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple          health information systems.   "
8116|NCT03179644|"     The primary objective of the study is to determine the correlation between mean pleural     pressure and oesophageal pressure in the immediate aftermath of bi-pulmonary transplantation.      In this research, oesophageal pressure will be measured by a nasogastric tube with an     esophageal balloon (also suitable for feeding the patient) usually installed at the time of     transplantation, pleural pressure will be measured by several Pleurocath-type catheters     (Prodimed Inc, France) which the thoracic surgeon will have positioned at the end of the     surgery without additional skin intrusion.   "
8117|NCT03179631|"     This study is a long-term study of ataluren in patients with nonsense mutation Duchenne     muscular dystrophy.   "
8118|NCT03179618|"     This study evaluates the clinical efficacy of Xuefu Zhuyu Decoction in the treatment of     unstable angina pectoris. All of the patients will be divided into 2 arms randomly. One of     the arms will be treated by conventional western medicine, the other one will be treated by     Xuefu Zhuyu Decoction at the base of conventional western medicine.   "
8119|NCT03179605|"     The purpose of this study is to evaluate the potential of DFD-06 to suppress the     hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.   "
8120|NCT03179592|"     The purpose of this study is to prospectively evaluate the effectiveness of low-volume     contrast media (CM) injection protocols adapted to tube voltage in patients undergoing     Coronary Computed Tomography Angiography (CCTA).   "
8125|NCT03179527|"     This study evaluates the clinical efficacy of Shuanghe Decoction in the treatment of unstable     angina. All of the patients will be divided into 2 arms randomly. One of the arms will be     treated by conventional western medicine, and the other one will be treated by Shuanghe     Decoction at the base of conventional western medicine.   "
8126|NCT03179514|"     This study evaluates the clinical efficacy of Gualou Xiebai Banxia Decoction compounded with     Danshen Decoction in the treatment of unstable angina pectoris. All of the patients will be     divided into 2 arms randomly. One of the arms will be treated by conventional western     medicine, the other one will be treated by Gualou Xiebai Banxia Decoction compounded with     Danshen Decoction at the base of conventional western medicine.   "
8127|NCT03179501|"     This is a Phase 1 placebo-controlled biomarker study of NP001 in individuals with Alzheimer's     Disease.   "
8128|NCT03179488|"     The intensity used during transcutaneous electrical nerve stimulation (TENS) in both,     clinical practice and research studies, is often based on subjective commands such as strong     but comfortable sensation. There is not consensus regarding the effectiveness dose of TENS   "
8129|NCT03179475|"     The study will be investigating the effectiveness of oxycodone-naloxone (brand name Targin®)     at treating chronic pain in individuals with spinal cord injury. The goal of the study is to     compare the effectiveness of Targin® at treating chronic pain in individuals with sub-acute     and chronic spinal cord injury compared to opioid medication that is not compounded with     naloxone.   "
18389|NCT03044847|"     The purpose of this study is to establish the large COPD cohort and biological database in     China, aiming for precision medicine to optimize diagnosis and treatment choices and to     monitor and improve clinical outcomes in this disease.   "
8133|NCT03179423|"     The monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous     Multiple Sclerosis associated RetroVirus (MSRV), which could play a critical role in     different autoimmune disorders, notably type 1 diabetes (T1D).      This study is a multicentre study evaluating for the first time the safety and efficacy of     GNbAC1 for 20 weeks in T1D subjects. The primary objective of the study is to assess the     safety and tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D.     Secondary objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of     T1D.   "
8134|NCT03179410|"     The purpose of this study is to assess the safety and efficacy of avelumab in patients with     metastatic neuroendocrine-like prostate cancer. Eligible men will be started on avelumab     every 2 weeks and will stay on therapy until progression or intolerable side effects. The     central hypothesis is that PD-L1 inhibition with avelumab will be efficacious based on     radiographic responses in a subset of men with metastatic neuroendocrine-like prostate cancer     and be reasonably well tolerated, meeting criteria for further study in larger phase 2 and 3     trials based on meeting pre-specified efficacy rates and prolonged PFS in some men.   "
8135|NCT03179397|"     To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate     vision when compared to a legally marketed monofocal IOL.   "
8136|NCT03179384|"     Acute pyelonephritis (APN) corresponds to infections of the renal parenchyma. The annual     incidence of these infections is estimated at 4-6 million cases in France, with 60 to 90% of     patients managed in general city medicine. The ceftriaxone, parenteral third-generation     cephalosporin (C3G), occupies an important place in the antibiotic treatment of these     infections: this is the recommended probabilistic treatment, and in some situations the     treatment can be continued in its entirety via a Ceftriaxone monotherapy.      The aim of the last antibiotic plan is to avoid the use of antibiotic therapies with a high     selection capacity (cephalosporins, penicillins, fluoroquinolones, etc.) and thus reduce the     incidence and prolongation over time of the digestive carriage of multi-resistant bacteria .      To date, there have been few studies evaluating the impact of ceftriaxone on the emergence of     multi-resistant bacteria on an individual scale, with rather heterogeneous results (13-86%     C3G resistance).      Thus, before considering randomized studies comparing the ecological impact of different     molecules or therapeutic regimens in the treatment of ANP, it is necessary to have a precise     and rigorous evaluation of the ecological impact of the molecule reference in this     indication.      The investigators propose a study to evaluate the impact on the digestive flora at 1 month of     a ceftriaxone antibiotic therapy (7 days) in the management of acute pyelonephritis in women.   "
8145|NCT03179267|"     In recent years there has been increasing focus on the earlier detection of deterioration in     the clinical condition of hospital patients with the aim of instigating earlier treatment to     reverse this deterioration and prevent adverse outcomes. This is especially important in the     ED, a dynamic environment with large volumes of undifferentiated patients, which carries     inherent patient risk. SNAP40 is an innovative medical-grade device that can be worn on the     upper arm that continuously monitors patients' vital signs including relative changes in     systolic blood pressure, respiratory rate, heart rate, movement, blood oxygen saturation and     temperature. It uses automated risk analysis to potentially allow clinical staff to easily     and quickly identify high-risk patients. The aim of this study is to investigate whether the     SNAP40 device is able to identify deterioration in the vital sign physiology of an ED patient     earlier than current standard monitoring and observation charting techniques.   "
8137|NCT03179371|"     Congenital diaphragmatic hernia (CDH) is a severe congenital malformation, related to a     developmental defect of the diaphragm. The incidence of CDH is approximated at 1 in 3,000     live births. Although advances in surgery and neonatal intensive care have improved the     prognosis, mortality remains high, around 30-50% related to severe lung hypoplasia and     persistent pulmonary hypertension. Prenatal evaluation with observed/expected Lung over Head     Ratio (o/e LHR), liver position and total lung volume measured by magnetic resonance, have     been shown to correlate with neonatal mortality . However, the preponderant factor of     persistent pulmonary hypertension remains difficult to predict prenatally. In patients with     isolated diaphragmatic hernia (without associated malformations or karyotype abnormalities),     prognosis is evaluated indirectly on pulmonary development from pulmonary volume     measurements. Apart from the most caricatural cases with extremely good or very pejorative     values, for a large proportion of fetuses with diaphragmatic dome hernia the prognosis     remains uncertain.      The aim of the proposal is to investigate whether the analysis of the proteom of the amniotic     fluid of the fetuses with CDH could give information of a prognostic character. The objective     of the study is to identify, from the proteomic profile of the amniotic fluid of mothers     whose fetus has CDH, prognostic markers candidates for death at 2 months of the infant. The     first step is to carry out an exploratory and non-interventional study on a small sample (n =     10) of the target population. This is a preliminary step before considering, if the results     are encouraging, a large-scale study from a biological collection to determine candidate     proteins (new biomarkers) which relative expression levels could be used as surrogate marker     of pulmonary hypoplasia.   "
8138|NCT03179358|"     In colorectal surgery, hand suturing and stapling are routine methods for performing     intestinal anastomoses, and these methods appear to be similar in terms of clinical safety.     Despite several years of experience with surgical procedures as well as improvements to the     medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis     after colorectal surgery remain a significant challenge for surgeons. In addition,     preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even     further.      The methods that are used today to detect leakages are unfortunately inaccurately and limited     to monitoring symptoms, temperature, CRP (C-reactive protein)-levels, and performing     abdominal examinations and CT-scans. These clinical signs and parameters usually become     apparent several days after onset of the leakage, which leads to a delayed diagnosis.     Anastomotic leakage is not only a significant cause of increased morbidity of complications     and mortality in patients, but also associated with increased risk of local recurrence and     poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma     may be made at the level of the sigmoid colon and this procedure impacts quality of life     negatively.      Based on the above considerations, a novel, adaptive anastomotic method has been developed by     CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking     Procedure (C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal     ends and validate the anastomosis, with function of Extract samples for analysis and conduct     X-ray through connected catheters).      The novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to     use, with unique possibility to control the anastomosis during and after surgery. The     previous successful preclinical study encourages a clinical verification in patients     undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking     Procedure by use of C-REX LapAid and C-REX DMH/DMHC.   "
8140|NCT03179332|"     This is a single-centre, randomised, double-blind, three-period, complete cross-over trial     comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin     lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of     basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject     will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which     the subject will receive the investigational products. In a euglycaemic clamp setting,     subjects will be given a bolus dose of 0.15 U/kg body weight.      Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of     100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic     assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose     concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp     procedure after dosing.   "
8141|NCT03179319|"     This study is testing the acceptability and feasibility of MyChoices, a mobile application     (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who     have sex with men (YMSM).   "
8142|NCT03179306|"     The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer     Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for     all kinds of settings, including lowresource ones that rely on development of robust,     low-cost screening and triage tools. Therefore, to support development of algorithms for     cervical image recognition software, NCI seeks to share digital cervical images and     accompanying clinical data from our large epidemiological studies on HPV and cervical cancer     screening with interested and qualified image analysis researchers. To accommodate the many     researchers that are interested, we have created this standard protocol to describe a unified     process for sharing deidentified cervical images and accompanying de-identified clinical data     from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical     Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .   "
8143|NCT03179293|"     The aim of this randomized double-blinded study is to determine whether transition to     propofol for 3 min at the end of sevoﬂurane anaesthesia reduces the incidence of EA in     children undergoing genito-urinary paediatric surgeries.   "
8144|NCT03179280|"     A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of     different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard     meals with varying composition. Participants were asked to consume 10 different combinations     of meal and bolus type.   "
8156|NCT03179124|"     Children with cerebral palsy (CP) have postural control problems due to the lack of motor and     sensory development. Trunk control which has an important role in ensuring postural control,     is the basis for sitting, mobility, development of the upper extremity, pulmonary function     and activities of daily living. Poor postural control restricts upper extremity functions     which also affects the quality of movements. For this reason, it is important to assess the     relationship between trunk control and upper extremity functions. This study is planned to     investigate the effect of balance and trunk control on upper extremity functions in children     with CP.   "
8146|NCT03179254|"     Patients scheduled to undergo ambulatory surgery are usually made non per os (NPO) at     midnight on the day prior to surgery. In the case of patients with type 2 diabetic mellitus     (DM) on treatment with oral hypoglycemic agent (OHA), patients are instructed to temporarily     discontinue treatment on the day prior to surgery. This advice is based on the concern for     intraoperative and postoperative hypoglycemia in this group of patients. Metformin , a     dimethylbiguanide, is widely used as an oral antihyperglycemic drug in the long term     treatment of type 2 DM. This instruction to withhold treatment may be imprudent given that     metformin by virtue of its mechanism of action does not cause hypoglycemia. Another concern     often cited as a reason to withhold metformin is the reported adverse effect of lactic     acidosis. However, a recent metanalysis by the Cochrane group found no cases of fatal or     nonfatal lactic acidosis in 70,490 patient-years of metformin use, or in 55,451 patient-years     for those not on metformin. Furthermore, discontinuing OHA treatment can result in disruption     of established glycemic control and intraoperative and postoperative hyperglycemia all of     which can be deleterious to the patient.      We hypothesize that uninterrupted treatment with OHA in type 2 DM patients undergoing     ambulatory surgery will not result in intraoperative and postoperative hypoglycemia (defined     as blood glucose < 60mg/dl) compared to patients withholding OHA treatment on the day of     surgery.   "
8147|NCT03179241|"     Selektive dorsal rhizotomy (SDR) has been used as treatment option in children suffering from     cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits.     Nevertheless, there are still no proven strategies for patient selection, optimal point of     time for the operation or pre- and postoperative therapies. The evaluation of the impact of     selective motor control, cognition and cerebral imaging findings on the motor outcome and     life quality in children with CP who underwent SDR at the Charité University clinics will     clarify these critical points in daily care for patients with CP.   "
8148|NCT03179228|"     The primary study objective is to evaluate improvement of symptoms from benign prostatic     hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months     post prostatic artery embolization (PAE) with bland microspheres.   "
8149|NCT03179215|"     Correction of arterial hypotension is essential for adequate cellular metabolism. maintaining     MAP above a minimum level has been recommended in order to prevent further tissue     hypoperfusion and organ dysfunction.Functional assessment of arterial load by dynamic     arterial elastance (Eadyn), has recently been shown to predict the arterial pressure response     to volume expansion (VE) in hypotensive, preload-dependent septic patients.   "
8150|NCT03179202|"     The purpose of this study is to evaluate the safety and effectiveness of electrical     stimulation (low levels of electricity) on low back pain. This study involves a Peripheral     Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the     muscles in the low back. The System includes up to four small wires (called Leads) that are     placed through the skin into the muscles in the low back. It also includes up to four devices     worn on the body that deliver stimulation (called Stimulators).   "
9134|NCT03166358|"     This study will determine the efficacy of an 8-week Hatha yoga intervention for adolescents     with tension-type headache (TTH) and will assess theoretically-driven mediators of treatment     response, including experimental pain sensitivity, chronic stress, and negative cognitions     linked to chronic pain.   "
8152|NCT03179176|"     In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the     identification of the tumor and its limitations in relation to the healthy brain; (ii) the     identification of functional cerebral regions, ie implicated in neurological function (motor     skills, sensitivity, language, vision, cognition, etc.). The reference method currently used     to improve the quality of resection of brain tumors while minimizing neurological risk for     patients is so called wakeful surgery with direct electrical stimulation (DES) of the     brain. The investigators routinely use ultrasound to localize the tumor within the brain, but     to date there is no pre- or intra-operative imaging tool to reliably identify tumors and     functional brain regions. There is therefore a need for innovative imaging in this field.      For this reason, the investigators propose to evaluate the interest of a new High Frequence     Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management     of patients operated in an awake condition for a brain tumor. The ultra high frequency allows     to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional     ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than     1 mm / second. The safety of this device is demonstrated and validated by CE marking     (December 2015).   "
8153|NCT03179163|"     High blood pressure can cause physical changes to the blood vessels of the body (remodeling).     If a person who has high blood pressure also has a lot of blood vessel remodeling with their     condition, they are more likely to have poor results with medical treatment for hypertension.     The researchers examine the impact of different classes of drugs that doctors use to treat     high blood pressure (hypertension) on blood vessel remodeling. Some drugs that doctors     prescribe for their patients contain a sulfhydryl group (a sulfur atom bonded to a hydrogen     atom). Drugs that have the sulfhydryl group may reduce blood vessel remodeling more that     drugs that do not. For this study, participants who have high blood pressure perform the     experiments, take a drug for 16-weeks to lower blood pressure, and repeat the experiments.     The researchers randomly assign one of three drugs to participants who have high blood     pressure: a diuretic (water pill), a drug containing a sulfhydryl (SH) group, or a drug     that does not contain a sulfhydryl group. Participants who do not have high blood pressure     perform the experiments, but do not take any of the drugs. In some of our experiments, the     researchers use a technique called microdialysis (MD). With MD, the researchers perfuse     some research drugs into the skin on the forearm through tiny tubing that mimics capillaries.     These MD drugs mimic or block substances the body naturally makes to control the small blood     vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go     into the rest of the body. The researchers also analyze very small skin samples (skin biopsy)     obtained from the forearm. Lastly, the researchers use a standard technique called flow     mediated dilation (FMD) that uses blood pressure cuffs and ultrasound to look at the health     of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin     under the tongue during part of the test.   "
8154|NCT03179150|"     To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD)     assisted reading for the identification of pulmonary nodules in chest Computed Tomography     (CT) from oncological patients with that of unassisted reading.   "
8155|NCT03179137|"     Cardiac ischemia is a common pathological condition, known to elicit multiple pathological     processes at the cellular level. One of the most affected is thought to be cellular     metabolism, key for the adequate cardiac function. The aim is to study mitochondrial     bioenergetic function, interaction with other cellular systems and influence of several     co-morbidities in myocardium of the affected patients.   "
8157|NCT03179111|"     This is a prospective study whereby it involves patients who are planned for Laparoscopic     Sleeve Gastrectomy. In Sleeve Gastrectomy procedure, a large portion of the stomach will be     removed. Pneumoperitoneum pressure will be the experimental aspect in this study. The     pneumoperitoneum pressure will be adjusted to either 8-10 mmHg of low pressure or to     12-15mmHg of standard pressure.   "
8158|NCT03179098|"     The elbow contracture is a secondary injury that can occur after direct trauma, causing the     patient to have limitations in their range of motion. Objective evaluation protocols that     help in decision making for the indication of these therapeutic resources have great value in     rehabilitation, as they reduce unnecessary expenses and improve the assertiveness in the     indication of this resource.      Objective: To verify the immediate effects of superficial heat associated with sustained     stretching through muscle activity and range of motion in the posttraumatic contractures of     the elbow seeking the best indication of orthosis.      Methods: Characterized as a randomized crossover type clinical trial. Sample of 20 adult     subjects, of both sexes, over 18 years old, with elbow stiffness due to fractures and / or     dislocations with indication of orthosis use. Patients will be divided into 2 randomly     assigned intervention groups: the control group (CG) who will perform the 10 'sustained     stretching drawn by a defined load through maximal voluntary isometric contraction (MVIC) and     the modified Weeks Group (GWM) will perform 20 'of surface heat through the swirl and soon     after the stretching sustained by 10' with already defined load. All patients will undergo an     initial assessment and will participate in all 2 interventions while respecting a 7 day     washout period. Goniometry and the visual analogue scale will be applied at the beginning and     end of the interventions. The Delsys® brand equipment will be used to collect the     electromyographic data. Placement and positioning of the electrodes will follow the     determinations of the Seniam protocol. The activation of the brachial, brachioradial and     triceps brachii muscles during the MVIC will be analyzed and also during the respective     intervention protocols.   "
8159|NCT03179085|"     People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD).     CKD is associated with increased risk for heart disease and death. The burden of chronic     kidney disease is increased among minority populations compared to Caucasians. New Mexico     American Indians are experiencing an epidemic of chronic kidney disease due primarily to the     high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is     designed to delay / reduce rates of ESRD by early interventions in CKD. Investigators propose     to assess the safety and efficacy of conducting a full-scale study to determine if home based     care delivered by a collaborative team composed of community health workers, the Albuquerque     Area Indian Health Board and University of New Mexico faculty will decrease the risk for the     development and the progression of CKD.   "
8169|NCT03178955|"     Primary objective: To determine the changes in circadian activity rhythms and disease     activity in rheumatoid arthritis (RA) patients from pre-treatment to one month after Enbrel     initiation.      Secondary objectives:        -  To determine if there is an association between changes in circadian rhythm and changes          in disease activity in active RA after initiation of Enbrel        -  To determine if the changes in circadian activity rhythms are associated with systemic          inflammation in RA patients        -  To determine changes in traditional sleep quality variables from pre-treatment to one          month after Enbrel initiation in RA patients   "
8170|NCT03178942|"     Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of     Scabies.   "
8160|NCT03179072|"     Managing fluid status is a complex but fundamental part of the clinical care of people     receiving haemodialysis (HD). Day-to-day fluid management is usually based on the concept of     'target weight' - the weight used to determine how much fluid should be removed during each     dialysis session. However, the focus of this approach is usually on avoiding fluid overload     (hypervolaemia), since this is associated with a higher incidence of cardiovascular and     pulmonary events, in addition to increased morbidity and morbidity. As a consequence, a     significant proportion of people on maintenance HD spend a great deal of time in a dehydrated     state. Although dehydration is known to be associated with a number of unwanted consequences     (e.g. headaches, severe fatigue, impaired cognitive and physiological function), there has     been little research focusing on the impact dehydration has on the physical and psychosocial     well-being of this patient group. Considering the short life expectancy of individuals with     end-stage renal disease (ESRD) reliant on maintenance HD, particularly those who are unable     to receive a renal transplant, we should be focused on improving their function and quality     of life (QoL).      Key issues that need addressing prior to developing interventions in this cohort are 1)     investigating the best and alternative measures to assess hydration status and 2) documenting     the biopsychosocial impact of typical target weight driven HD in a well-designed study.   "
8161|NCT03179059|"     Given the high rate of delayed adoption of antenatal care (ANC), and high rates of unintended     pregnancy and unsafe abortion in Uganda, research on the period of time before confirmation     of pregnancy is critical to understand underlying beliefs that guide behaviors ultimately     important for maternal and neonatal health (UDHS, 2011; Hussain, 2013).      Home pregnancy tests - which now cost less than 10 cents each - have the potential to     facilitate FP uptake and significantly improve reproductive, maternal and child health     outcomes in sub-Saharan Africa, including Uganda. These tests are easy to administer,     disposable, inexpensive, and have a low false positive rate. Yet, for women living in rural     areas in sub-Saharan countries, these tests are typically unavailable outside of health     centers or they are prohibitively expensive.      This study will investigate women's underlying beliefs about pregnancy status and examine how     providing access to home-based pregnancy tests - thus facilitating earlier resolution of     uncertainty of pregnancy status - influences such beliefs and decisions to take up family     planning (FP) or seek appropriate pregnancy services.      The results will inform the design of a larger study in the future.   "
8162|NCT03179046|"     This study is designed to investigate the association of the clinical and laboratory     parameters or data with the cardiac structural and functional abnormalities in systemic lupus     erythematosus(SLE). Patients with at least four ACR classification criteria for SLE and     stable clinical condition (no need for immunosuppressive therapy intensification, i.e.     current immunosuppressive drug dose increase or introduction of an additional     immunosuppressive drug within last 3 months) will be included in the study. Study procedures     will include clinical evaluation, lab tests including blood counts, liver and kidney     functions and antibodies levels such as ANA, antiphospholipid antibodies, anti-ds DNA as well     as inflammatory markers such as sedimentation rates. Also evaluation of cardiac status by     cardiologist examination echocardiography and gadolinium enhanced cardiac MRI. Next,     correlation between cardiac abnormalities and laboratory changes will be statistically     analyzed.   "
8227|NCT03178201|"     Primary Objective: Determine the ORR of TGR-1202 in R/R FL.      Secondary Objectives        -  Determine the genetic and other novel biological markers that may be predictive of          response or resistance to TGR-1202 in patients with relapsed or refractory FL.        -  Describe the Progression Free Survival (PFS), Duration of Response (DoR) after treatment          with TGR-1202.        -  Describe the number of dose delays and dose reductions and other safety profile.   "
8163|NCT03179033|"     Left Ventricular Assist Device (LVAD) implantation is a common surgical procedure in patients     with end-stage heart failure. Optimal fluid management is essential for adequate     postoperative treatment. It is important to identify which patients will benefit from fluid     administration. Passive leg raising (PLR) is a validated dynamic method to predict fluid     responsiveness in patients with heart failure by inducing a transient increase in cardiac     preload. Objective: To investigate the role of PLR on the management of patients following     LVAD implantation in the postoperative period.   "
8164|NCT03179020|"     This study consists in an cluster-randomized clinical trial involving near 60 Brazilian     intensive care units (ICUs) with a high notification rate of potential donors of organs and     tissues. ICUs will be randomized in a 1:1 ratio to manage potential organ donors through the     use of a evidence-based checklist or to manage potential organ donors according usual care.     The primary outcome is the rate of losses of potential donors due to cardiac arrest.     Secondary outcome measures include number of effective organ donors, number of organs     recovery per effective donor and total number of cardiac arrest among all potential donors.   "
8165|NCT03179007|"     This is a single-arm, open-label, one center clinical study, to determine the safety and     efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies     (CTLA-4 and PD-1) and chimeric antigen receptor targeting MUC1 in adult patients with MUC1     positive, advanced recurrent or refractory malignant solid tumors.   "
8166|NCT03178994|"     To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in     Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12     weeks.   "
8167|NCT03178981|"     This study will compare nicotine delivery and product satisfaction in healthy subjects either     using several different types of electronic cigarettes or smoking a conventional cigarette.   "
8168|NCT03178968|"     The clinical study was a single-blind, randomised intervention study to measure surface     changes of polished and unpolished enamel in situ following an orange juice acid challenge.     Ethical approval for the study was granted by the Stanmore Health Research Authority REC ref     15/LO/0417, and the study was conducted per the guidelines for Good Clinical Practice. The     study investigated a total 6 erosion regimes divided in 3 different erosion times plus ex     vivo immersion in orange juice drink versus in vivo rinsing of the same orange juice drink.   "
8171|NCT03178929|"     The aim of this study is to explore the effect of SAMe on recurrence after radical treatment     of Primary liver cancer.   "
11231|NCT03138902|"     The purpose of this study is to evaluate the validity of using a carbohydrate intolerance     questionnaire (CIQ) and/or other health markers as a means of predicting response to insulin     sensitivity as determined by an oral glucose tolerance test (OGTT).   "
8174|NCT03178890|"     Advanced prosthetic devices are currently controlled by electromyography (EMG) signals     generated by patient's stump muscles and recorded by surface electrodes attached on the skin.     This way of recordings is often unreliable, inconsistent and leading to high prosthetic     abandonment rates for individuals with upper limb amputation. The use of implantable     electrodes has been long thought as the solution for a more natural control of artificial     limbs, as these offer access to long-term stable and physiologically appropriate sources of     control, as well as the possibility to elicit appropriate sensory feedback via     neurostimulation.      This Clinical Investigation (CI) is performed to clinically test and verify the safety and     benefits of a bidirectional interface into the human body that allows permanent and reliable     communication using implanted electrodes. These electrodes will provide long-term stable     bioelectric signals for an improved control of artificial limbs. The bidirectional interface     is based, and requires, the clinically established implant system for bone-anchored     prostheses named Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA). The     feasibility of the device was initially proven through a proof-on-concept patient who has     used the system without any adverse events for more than three years.      This CI is performed to verify the safety and benefits of the Osseointegrated Human Machine     Gateway (OHMG) as an enhancement of the OPRA Implant System for patients with upper limb     amputation, when used within the intended purpose and according to instructions. The CI will     be performed at Sahlgrenska University Hospital and Chalmers University of Technology,     Sweden. A maximum of eighteen patients will be enrolled. Each patient will undergo a surgery     where the OHMG will be implanted. The patients will participate in 8 follow-up sessions, the     last one approximately 13 months after the surgery. The study is prospective, where the     patient is his/her own control.   "
8175|NCT03178877|"     A cross-sectional study of 350 medical student Universitas Indonesia from first grade until     fifth grade was done during November-December 2016. This study used stratified randomized     sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview     was applied to all subjects.   "
8176|NCT03178864|"     SECRET examines the safety of rivaroxaban versus standard-of-care for treatment of     symptomatic cerebral venous thrombosis, initiated within 14 days of diagnosis.   "
8177|NCT03178851|"     This study will evaluate the preliminary efficacy, safety, and pharmacokinetics of     cobimetinib and atezolizumab in participants with advanced BRAF V600-wild type (WT),     metastatic, or unresectable locally advanced melanoma who have progressed on prior anti−PD-1     therapy. In addition, this study will evaluate the efficacy, safety, and pharmacokinetics of     atezolizumab monotherapy in participants with BRAFV600-WT metastatic or unresectable locally     advanced melanoma, who have not been previously treated.   "
8284|NCT03177460|"     The goal of this clinical research study is to learn about the safety and tolerability of     giving Darzalex (daratumumab) to patients who have prostate cancer before having an     already-scheduled prostatectomy (surgical removal of the prostate).      Researchers also want to learn if daratumumab can help to control the disease before the     prostatectomy.   "
8178|NCT03178838|"     The buccal cavity presents microorganismes whose the number and composition vary with oral     hygiene and medical context (pathologies and associated drug therapies) of the patient. More     than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the     sub-gingival biofilm. Among all these microorganismes, only 20 species participate to the     etiopathogenesis of periodontal diseases.Some are recognised as major periodontopathogens     other play unclear role in this pathology. They belong respectively to the red and orange     complex of Socransky et al. (1998).      Other microorganismes such as virures, yeasts and protozoans could potentially impact the     emergence and development of periodontal diseases. The presence of protozoans in     periodontitis have been investigated in this study.   "
8179|NCT03178825|"     This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid     fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of     Menopause.   "
8180|NCT03178812|"     This study aims to find a correlation between cytokines levels and malignancy potential of     different cystic types.   "
8181|NCT03178799|"     Aims: To compare clinical outcomes for patients under FLS or usual care at the NTUH MH and     BB.      Method: Four hundred subjects with new hip fracture or newly identified vertebral fracture     are randomly assigned into FLS and usual care (UC). FLS subjects received     osteoporosis-related assessments, treatments, consultations on diet, medications, exercise,     fall preventions given mainly by care managers with followed up telephone call at 4, 8, 12,     18, 24 months then annually for up to 10 years. Physicians manage UC subjects at their own     plans without pre-specified protocols as FLS subjects. Care managers will perform baseline     assessments and follow them by telephone annually for up to 10 years. Major outcomes include     bone mineral density assessment rate, calcium, vitamin D, and osteoporosis medication     initiation and adherence rate, fall and fracture incidences, mortality, and healthcare     resource utilizations.   "
8182|NCT03178786|"     The purpose of this dual phase cross-sectional, controlled and prospective, open label,     exploratory study is to determine the general characteristics of visuospatial exploration and     its neural substrate in subjects with Parkinson's Disease (PD) and to explore the impact of     professional art therapy intervention in a cohort of subjects with Parkinson's Disease on     visuospatial exploration, visuomotor integration, neuropsychological and emotional sphere,     quality of daily living and motor symptoms.   "
8183|NCT03178773|"     This is an intervention to study incorporating social support into mHealth interventions for     low-income, ED patients with diabetes   "
8184|NCT03178760|"     The purpose of this study is to measurement of optic nerve sheath diameter in children     without intracranial pressure increase and determine the average optic nerve sheath diameters     for healthy children.   "
8185|NCT03178747|"     To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional     Giemsa stain in patients with herpes infection.   "
8186|NCT03178734|"     The purpose of this study is to compare UTI rates and patient satisfaction associated with     indwelling Foley catheter verses a valved catheter in patients who cannot void spontaneously     immediately after urogynecologic procedures via a Randomized Clinical Trial.   "
8187|NCT03178721|"     Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many     diagnostic and management challenges. One such challenge is the excess cardiovascular disease     observed in patients with Systemic lupus erythematosus . Coronary heart disease and other     manifestations of atherosclerosis continue to be a major cause of death in patients with     Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator     of the immune system that inhibit pathological immune response by suppressing both     uncontrolled protective immune response and damaging autoimmune responses   "
11401|NCT03136666|"     The objective of the study was to investigate the pharmacokinetics as well as safety and     tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under     fasting conditions in healthy male subjects.   "
8192|NCT03178656|"     According to the guidelines recommended, only a few new targeted therapy drugs treatment,     such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our     previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone     and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3     year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect     is obviously better.   "
8193|NCT03178643|"     This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in     children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will     enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three     malaria chemoprevention regimens, and follow participants monthly for 12 months in order to     record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the     efficacy of each regimen to prevent malaria and SCA morbidity.   "
8225|NCT03178227|"     Before February 2018 the baseline survey is conducted in about 60 class in Brazilian     secondary schools. These classes are randomized to control and intervention group in a 1/1     manner. A few weeks thereafter medical students from the local medical school visit the     schools and perform a smoking prevention intervention called photoaging mirroring     intervention which takes about 45 minutes. One month and six months after the intervention     the intervention group receives another anonymous questionnaire monitoring smoking status.     The primary endpoint is the difference in the chance of smoking prevalence between the two     groups.   "
8194|NCT03178630|"     Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and     Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among     adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate     predictive value for the progression of hepatobiliary damage in subjects with pediatric onset     AILD. This study will involve collection of MRI-based data at the time of enrollment and at     year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment.     There is a strong possibility that MRI quantitative techniques may be more sensitive to     disease progression than standard clinical and laboratory tests. To investigate predictivity     of MRI based biomarkers, summary measures of MRCP/MREL from baseline, Year 1 and Year 2, e.g.     change rate, maximum, and average will be calculated as predictors for Year 10 clinical     outcomes. The same predictors will also be used to model native liver survival in a     proportional hazard regression. Findings from this study may be used to assess disease     progression and to predict complications and survival of liver disease patients.   "
8195|NCT03178617|"     This randomized clinical trial studies how well a high-intensity intervention parenting     program works in improving learning and school functioning in Latino children with acute     lymphoblastic leukemia, acute myeloid leukemia, or lymphoblastic lymphoma. A high-intensity     intervention program may help doctors to see whether training parents or caregivers in     specific parenting skills and pro-learning behaviors will result in better learning and     school outcomes for Latino children with acute lymphoblastic leukemia, acute myeloid     leukemia, or lymphoblastic lymphoma. It is not yet known if a high-intensity intervention     program is more beneficial than a standard of care lower intensity parenting intervention.   "
8196|NCT03178604|"     In this study we intend to apply a treatment protocol for hamstrings that can be beneficial     for a good recovery.      Initially, a sample of athletes with hamstring shortening was chosen. Once the sample is     chosen, it will be divided into three groups: group 1 (G.1) who will receive a massage     protocol, group 2 (G.2) that receives the muscular chain approach, and last group 3 (G.3)     Placebo.      To finalize the study comparing the results of the three groups to observe the experimental     protocol obtains better results.      Material and methods The sample of an athletic club. Recruiting subjects between 18 and 45     years old without other injuries of the lower limb. Subjects with shortening of the hamstring     muscles are available through the specific shortening test.      This is a randomized controlled trial. Subjects were randomly assigned to three intervention     groups (2 treatment and 1 placebo control). The intervention consists of 4 sessions for 1     month. The sessions have a duration of 45 minutes. Evaluations are performed at the beginning     of treatment, at the end of treatment and one follow-up per month. Participants also perform     strengthening exercises three days a week, a total of 3 sets with 15 repetitions each.      Group 1 receives a massage treatment of the quadriceps and hamstrings. Group 2 receives an     equilibrium-oriented treatment of the anterior and posterior muscle chains of the lower limb.      Group 3 received placebo treatment. The hands of the physiotherapist rest for 10 minutes in     the quadriceps and hamstrings without intention of treatment.      In addition, all groups work on strengthening the muscles of the lower limbs with eccentric     work 3 times a week.      The assessments consist of knee and hip goniometry, lumbar and hamstring flexibility by     finger-to-floor testing, pain measurement on the visual analogue scale (EVA), and complete     the questionnaire Mood Status Profile (POMS) , Which evaluates the states of mind   "
8197|NCT03178591|"     Type 2 diabetes mellitus (type 2 DM) is an important disease with increasing prevalence     worldwide. More than 60% of diabetes patients die of CVD. Diabetes is associated with 2-to 4-     fold increase in the risk of coronary artery disease (CAD). Diabetes patients with stable     ischemic heart disease may have more prevalent of asymptomatic ischemia or silent ischemia     due to autonomic neuropathy. Therefore, detection of total myocardial ischemia including both     symptomatic and silent ischemia using ambulatory electrocardiogram monitoring may provide     better accuracy in ischemic burden and prognosis in diabetes patients. DDP-4 inhibitors have     favorable effects on atherosclerotic risk factors beyond glycemic control. Furthermore, DPP-4     inhibitors may have favorable effects on ischemic preconditioning in patients with CAD. For     this study we aim to compare the effects of between vildagliptin and Dapagliflozin on     ischemic burden defined by total ischemic time, markers of autonomic function, biomarkers of     myocardial injury and biomarkers of inflammation.   "
8198|NCT03178578|"     This prospective observational study aims to (i) asses intensive care doctors trigger for and     the expected physiological response to a fluid bolus and (ii) evaluate the patient's actual     physiological response to a single fluid bolus at one hour post-bolus for 100 adult patients     admitted to the intensive care unit will be included in the study.   "
8199|NCT03178565|"     The present study aims to evaluate the effect of mechanical insufflation-exsufflation on     airway mucus clearance among mechanically ventilated ICU patients. A parallel group     randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a     tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical     ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1     ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation     device (intervention group) or standard respiratory physiotherapy without the use of the     mechanical insufflation-exsufflation device (control group). The primary outcome is the     amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of     respiratory physiotherapy.   "
8200|NCT03178552|"     This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate     the safety and efficacy of targeted therapies or immunotherapy as single agents or in     combination in participants with unresectable, advanced or metastatic NSCLC determined to     harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as     identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA)     assays.   "
8201|NCT03178539|"     Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in     post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and     ketorolac tromethamine on post-tonsillectomy bleeding   "
8223|NCT03178253|"     Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality     of life, and on morbidity and mortality through the complications that affect the small and     large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease     has been emphasized by the findings of the national commission (USA) on diabetes .      So, there was curiosity to understand and learn the association of this disorder with another     common endocrine gland function that is thyroid gland . The association between these two     disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic     population varies widely between studies. With insulin and thyroid hormone being intimately     involved in cellular metabolism and thus excess or deficit of these hormones result in     functional derangement of the other.   "
8224|NCT03178240|"     Randomized trial looking at the effects of a behavioral photoaging software intervention on     sunscreen use in the city of Itauna, Brazil.   "
8202|NCT03178526|"     Aim: this double-blind split-mouth clinical trial study was performed to evaluate the     clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling     and root planning (SRP) in the treatment of chronic periodontitis.      Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3     mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel     periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular     molars were selected for the study.      Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were     recorded for the selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments     were performed at baseline and after 6 months. At one side the pockets around randomly     selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case     group=B), and on the other side, the pockets were filled with a placebo gel by a blunt     syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for     statistic analysis Spss 23.( P<0.05) was considered significant.   "
8203|NCT03178513|"     New or worsening symptoms following discharge from the hospital likely leads to unplanned     readmission. These rates are higher than desired and costly to patients, payers, and     providers. Many interventions have unsuccessfully attempted to reduce readmissions, but few     have provided in-home personnel to patients transitioning from acute care back to ambulatory     care. Still fewer have involved a physician in the home. We therefore will test the effect of     a physician home visit to a patient's home who was discharged in the last 4 days.   "
8204|NCT03178500|"     A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation     induction with the stair-step protocol. Sixty women will be included after obtaining their     written informed consent and will be randomized into either of the 2 groups.   "
8205|NCT03178487|"     This is a Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled study to     evaluate the safety and efficacy of upadacitinib in participants with active ankylosing     spondylitis (AS).   "
8206|NCT03178474|"     Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer     infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual     nutrients as compared to breast-milk in term Chinese infants.      Participants：189 healthy termed-infants with ages of 5-14 days at the enrollment.      Study Design: A multiple-center, quasi-randomized,open labeled, controlled trial. Random     allocation between the two infant formula.      Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2)     JINLINGGUAN Formula Group：fed with JINLINGGUAN infant formula (PRO-KIDO™ I-PROTECH®, Phase     I); (3) TOFER Formula Group: feeding TOFER infant formula (TOFER®, Phase I). Random     allocation performed between the two formula groups.      Intervention Duration: 12 weeks.      Visits: 1 week(baseline), 7 and 13 weeks of age      Outcome measures: (1) General information, general health and wellbeing, regular body     check;(2) Anthropometric parameters: body length, body weight, and head circumferences; (3)     Stool characteristics (color , volume, stool consistency, and frequency;(4)Behavior and     habits; (5) Gut microbiota; (6) Residual nutrients in feces (nitrogen,total fat, fatty acids,     minerals); (7) adverse events and concomitant medications; (8) compliance. Slopes of changes     from baseline to 6 and 12 weeks post intervention in anthropometric parameters, stool     characteristic index, fecal residual nutrients, pattern score of gut microbiota, behavior and     habit index were be calculated.   "
8207|NCT03178461|"     To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal     outcomes.   "
8208|NCT03178448|"     The objective of this study is to characterize the prevalence of clinical or subclinical     polyvascular lesions and 4-year progression rate of plaque in intracranial and carotidal     arteries in a Chinese community population using vascular imaging techniques; to investigate     the both traditional and emerging genetic, metabolomic, and environmental risk factors of     presence and progression of intracranial and carotidal plaque; and to investigate the     association between polyvascular lesions and future risk of cognitive impairment,     cardio-/cerebrovascular events and death.   "
8209|NCT03178435|"     An interventional controlled trial to test the feasibility of applying risk score based     prevention for critically ill patient at high risk to develop acute kidney injury (AKI)   "
8357|NCT03176511|"     Poor balance is one of the major risk factors for falling in older adults. A Matter of     Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite     its name, MOB focuses on managing concerns about falling, and does not include a balance     component. We are testing to see if adding a dual-task balance component (balance and mental     thinking) to MOB can improve balance and walking better, than MOB only.   "
8358|NCT03176498|"     This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells     (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological     function of convalescent period.   "
8210|NCT03178422|"     Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to     deliver nicotine into the systemic circulation via the skin. They have been found to reduce     craving, thereby enhancing a patient's success for quitting smoking. However, side effects     such as sleep disturbances and skin irritation, as well as incomplete smoking cessation are     commonly experienced by users of such systems. Chrono Therapeutics, Inc. has developed an     innovative programmable transdermal drug delivery system called the Chrono Quit Smoking     Solution (CQSS2) that provides off periods (periods in which little to no nicotine is     delivered), which is an advantage over existing systems that currently provide continuous     delivery. The most important features of the CQSS2 are the periodic automatic dosing, plus     the reduced side effects of sleep disturbances and potentially, skin irritation. The period     when less nicotine is being delivered through the skin allows the skin an opportunity to     recover, thereby potentially reducing skin irritation. Another major benefit is the     automatic dosing, which provides higher drug dosage at specific times of the day, leading to     potentially greater success in quitting smoking. In this study, the CQSS2 will be used in     conjunction with the Digital Coach application (app). The Digital Coach is a custom mobile     app that provides behavioral support for the CQSS2. Together, the CQSS2 and the Digital Coach     comprise the CQSS2 System.   "
8211|NCT03178409|"     Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The     aim of this study was the analysis of the outcome comparing such tumor with classic     hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).   "
8212|NCT03178396|"     The investigators will be studying the effect of melatonin on blood pressure, insulin     resistance, and platelets, along with possible reasons for how melatonin cases these effects.   "
8226|NCT03178214|"     This is a single centre, open-label, randomised, single dose, three-period, crossover study     to evaluate the bioavailability of Infacort® administered as 'sprinkles' with soft food and     yoghurt compared with direct administration to the back of the tongue in     dexamethasone-suppressed healthy adult male subjects.      The study will comprise of a pre-study screen, followed by 3 treatment periods and a     post-study follow-up.   "
8213|NCT03178383|"     This population-based application responds to the American Cancer Society Research Scholar     Grant, Priority Program in Cancer Control. Recent years have seen a growing research interest     in learning how to get known-effective health education strategies to reach more people who     could benefit from them. An important part of this growing movement is a focus on sustained     impact, or continued program benefit after the funding period is over. It is believed that     the best way to achieive this sustained impact is through integrating the program into the     host community at multiple levels. This innovative strategy has not been systematically     tested in community-based settings, where the most vulnerable people can be reached. Since     churches have a historical and ever-growing role in health promotion particularly among     African Americans, they are an ideal place to reach this group for cancer education. The     proposed project will compare two ways to apply a known-effective cancer educational strategy     through African American churches: 1) a standard method vs. 2) a new method in which the     churches integrate the strategy into their organizational structure and practice at multiple     levels. It will be determined whether this integrated approach results in more effective     and sustained cancer education and screening activities at both the church and individual     levels over time. The educational strategy is one that has been used successfully in previous     work: Project HEAL (Health through Early Awareness and Learning). Project HEAL is a series of     three cancer early detection workshops (breast, prostate, colorectal) delivered through     trained and certified lay peer community health advisors in African American churches. 14     churches will be randomly chosen to conduct either the standard Project HEAL program or an     integrated Project HEAL strategy where the churches build the program into their organization     in multiple ways (e.g., allocating volunteer or paid staff, space, or funds; policy change;     ministry development). The project will be conducted in three phases: 1) refining the     integrated approach with community and stakeholder feedback; 2) pilot testing the integrated     approach in 2 churches; and 3) conducting the study to comparatively evaluate the standard     vs. the integrated approaches in 14 churches. A scientifically rigorous evaluation plan will     be used to look at outcomes at both the individual and the church level. This project will     make important contributions to research in evidence-based medicine and sustainability. In a     climate of limited resources, identifying sustainable and effective ways to increase cancer     awareness and screening in African American men and women is more important than ever.   "
8214|NCT03178370|"     Autonomic, inflammatory, enteric, electrophysiologic and hormonal.   "
8215|NCT03178357|"     Hypertrophic cardiomyopathy (HCM) is the most common hereditary disease characterized by left     ventricular hypertrophy and consequently left ventricular diastolic function. Its prevalence     is estimated at around 0.2% in the general population. HCM is the most common cause of sudden     cardiac death due to cardiovascular disease in young athletes, accounting for one third of     deaths. HCM patients often have symptoms of heart failure. The ESC recommendations for heart     failure (HF) from 2016 recommend exercise training regardless of ejection fraction to improve     exercise capacity, quality of life, and reduction in hospitalizations due to HF. Meanwhile,     for many years, HCM was equivalent to exercise training limitation. According to the 2014 ESC     guidelines, it is recommended that patients with HCM avoid sports practice. Edelmann et al.,     however, suggest that physical training brings significant improvement in patients with     diastolic dysfunction and thus may be beneficial in patients with HCM. In 2015, Klempfner et     al. published the results of a first study, which showed that the majority of HCM patients     with moderate risk undergoing supervised physical training had improved physical performance,     no significant adverse events were recorded. The study was limited by the small number of     admitted patients (twenty), lack of control and failure to perform cardio-pulmonary exercise     test. The main goal of our study will be to evaluate the effectiveness and safety of     comprehensive cardiological rehabilitation and telerehabilitation in patients with     hypertrophic cardiomyopathy without left ventricular outflow tract obstruction with preserved     systolic function. The study is planned to include 30 patients with HCM subjected to physical     training and 30 patients with HCM in the control group treated as standard according to     current guidelines, not subjected to physical training.   "
8217|NCT03178331|"     The aims of the study are 1) to explore whether part of the school doctors' routine health     checks can be omitted using screening questionnaires which address the parents', school     nurses' and teachers' concerns regarding each student and 2) to evaluate the benefits of     school doctors' routine health checks.   "
8218|NCT03178318|"     Ability to provide oxygen to patients undergoing general anaesthesia is crucial. This is     traditionally provided using face mask, supraglottic airway (breathing tube above voice box)     or endotracheal tube (breathing tube in wind pipe). However in some patients it may be     impossible to provide oxygen through any of these above means which can be life threatening     and lead to permanent brain damage/death. One of the ideal ways of managing this emergency     situation is to pass a breathing tube through a membrane in the front of the neck called     cricothyroid membrane with the neck in extension position where permitted. Many studies have     recommended identifying the cricothyroid membrane before general anaesthesia in high risk     patients but with their head in neutral position. This study will be a pilot study to check     if the cricothyroid membrane remains in the same place in neutral and extended positions.   "
8219|NCT03178305|"     The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle     change and a better disease management. The study aims to support patients with behavior     change by providing them with devices and behavioral intervention in order to facilitate     long-term behavior change.   "
8220|NCT03178292|"     To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in     reducing upper urinary tract infection and urosepsis after PCNL.   "
8221|NCT03178279|"     People suffering from psychotic illnesses (e.g. schizophrenia) have poorer physical health     than the general population. The reasons include a lack of service user motivation to attend     physical health checks and the tendency of health professionals to focus mainly on the mental     disorder thus delaying the detection of physical health conditions.      Identifying people who have physical health needs is increasingly recognised as a priority.     The investigators have developed a Physical Health Plan (PHP) which is completed by service     users and identifies areas of physical health need. An action plan is then completed by the     service user and care co-ordinator to address these issues.      The PHP is designed to be very simple to use and there will be 3 versions, 1. paper version,     2. 1 version implemented via the 'IMPARTS' computerised 'tablet' based system that has been     separately evaluated (REC Ref 12/SC/0422) and 3. 1 version on an iPad via the MHL2 system via     Mindwaves.      The investigators wish to pilot the use of this PHP in two community teams in the South     London and Maudsley (SLaM) Trust. The pilot will be done in three stages.      Stage One: The investigators will undertake an initial qualitative study to refine the     process of using the PHP using focus group consultations with staff and service users.      Stage Two: The investigators will then undertake a six month study to evaluate the uptake and     use of the PHP. This will involve collecting data on how many people complete the PHP and     what actions are taken following the completion of the PHP.      Stage Three: At the end of this six month period the investigators will undertake qualitative     interviews with a selection of service users and staff to understand their experience of     using the PHP.      The investigators hope to be able to use the results of this pilot study to introduce the use     of the PHP into routine care.   "
8222|NCT03178266|"     This study is a prospective, randomized, single center, study to evaluate Zip Closure Device     in subjects undergoing knee arthroplasty. Patients identified as candidates for knee     arthroplasty and meet the study selection criteria will be approached and considered for the     study. Knee Arthroplasty of 40 subjects will be enrolled where 20 subjects will receive     ZipLine and 20 subjects will receive Staples.   "
8437|NCT03175458|"     30 recruited patients indicated for sinus membrane elevation with simultaneous implant     placement. patients are divided into 2 groups each group contain 15 patients, one group     assigned for placement of bovine bone graft after membrane elevation and insertion of the     implants while the other group assigned for graft-less tenting technique after membrane     elevation and insertion of the implant.   "
8228|NCT03178188|"     forty DLE lesions from patients will be recruited in the study. The lesions on one side of     the body were block-randomized into the treatment group and the other side served as a     control. The patients can continue their systemic treatments and the PDL is designed to be     used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment     group every 4 weeks for 4 consecutive months while the lesions in the control group received     a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up     period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture     index (TI) will be obtained and digital photographs will be taken and modified Cutaneous     Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit.     The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side     effects and patients' satisfaction score will also be recorded.   "
8229|NCT03178175|"     This plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture     technique specialized to neurological disorders, in managing motor function and body balance     for PD patients. This is a randomized, controlled, single-blind clinical trial.   "
8230|NCT03178162|"     There are different methods for measuring cardiac output (CO) completely non-invasive, which     are used today. Two of these should be used in the study to examine the CO in an older group     of patients (> 65 years) undergoing major trauma surgery. The first method is the     esCCOTM-technology by Nihon Kohden, the second uses the Volume Clamped Method via a     finger-cuff by Nexfin Edwards life sciences. Both technologies work continuously and fully     non-invasive.      The measured data will be compared to established standard procedures like semi-invasive     pulse contour analysis using the Flotrac-Vigileo system. The study should answer the     following questions:      How accurate and precise are the non-invasive methods? How large is the percentage deviation     in comparison to the established standard? Are there any limitations of measuring accuracy     regarding the age of the patient? The continuous hemodynamic monitoring of patients during     surgery has recently changed from invasive and semi-invasive methods to completely     non-invasive technologies. The accuracy and precision of this way of measuring cardiovascular     parameters in comparison to the invasive standard is still controversial. Especially for     older patient with atherosclerotic alteration of the blood vessels the utility of     non-invasive monitoring systems is not shown yet. But principally this group with a high     level of comorbidity might profit notably from less invasive procedures. This is the reason     for the planed research.   "
8231|NCT03178149|"     The purpose of this study during the Dose Escalation stage is to assess the safety and     tolerability of 3 ascending doses of ASP7317 in participants with age-related macular     degeneration (AMD), of which one dose will be selected for evaluation of efficacy and safety     during the Proof of Concept (PoC) stage of the study.      The primary purpose of the study during the PoC stage is to assess the safety, tolerability     and superiority of ASP7317 at low cells/ dose and the selected dose compared to untreated     control and ASP7317 low cells/dose versus the selected dose in best corrected visual acuity     (BCVA).      This study will also assess the differences among ASP7317 at low cells/ dose, ASP7317 at the     selected dose and the untreated control group in microperimetry and fundus autofluorescence     parameters during the PoC stage.   "
8232|NCT03178136|"     It is universally accepted that the persistent infection of high-risk human     papillomavirus(HR-HPV) is the cause of cervical intraepithelial neoplasias and cancer. Some     researches indicate that the virus load may relate the extent of the disease. The objective     of the study is to detect the virus load of 14 types HR-HPV among the participants, using a     new HPV DNA hybrid capture technology,sequentially find the diagnostic significance of virus     load of HPV.   "
8233|NCT03178123|"     This is a phase II randomized, control, multi-center study of recombinant humanized anti-PD-1     mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has     been removed by surgery.   "
8260|NCT03177772|"     The investigators are adapting Complicated Grief Group Therapy (CGGT) for soon-to-be bereaved     dementia caregivers at risk for complicated grief—Pre-Loss Group Therapy (PLGT) to facilitate     healthy death preparedness and eventual bereavement. This will be the first known application     of proven therapeutic strategies to address complicated grief applied to high-risk dementia     caregivers prior to care recipient death to mitigate complicated grief. If proven to be     effective in attenuating poor bereavement outcomes, PLGT could be translated into     comprehensive caregiver support programs and delivered to active caregivers of living persons     with dementia at risk for complicated grief through community-based caregiver support groups.   "
8234|NCT03178110|"     The objectives of this pilot study are to determine the effectiveness of a manual therapy     (MT) protocol plus the use of a dynamic jaw opening device on the maximal interincisor     distance; on trismus symptoms; on pain-disability outcomes and on the quality of life,     anxiety, and depression in subjects with trismus. The proposed pilot study will comprise a     single subject design with multiple baseline measures and during treatment phases to     determine the effectiveness of the treatment protocol. A minimum sample of 10 subjects will     be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this     study. Participants will receive a MT protocol plus exercises and the use of the DTS device     for 6 months. The first two weeks of treatment will involve only MT and opening     exercises.After this initial 2 weeks, the DTS will be introduced. The participants will     receive a session of 30-45 minutes of MT three/two times per week, for 24 weeks. All     participants will be instructed how to use the Dynasplint® Trismus System at home.      Analyses: Visual analyses will be performed on participant before, during, and after the     intervention. The 2-standard deviation band method will be used to analyze the behavior of     each participant on the outcome of interest before, during, and after the treatment. The     minimally important difference levels in order to determine clinical relevance will be done.     Two effect size indexes will be used: the percentage of non-overlapping data, and the     percentage of improvement rate difference.   "
8279|NCT03177525|"     Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social     initiation and there are no empirically validated treatments specifically for this core     deficit. While parent training is known to be a critical intervention component, few social     skills programs involve parents. This study will capitalize on an existing social skills     group already established at the community agency Abilities United, with the goal of     enhancing the program's effectiveness by adding a parent component. Specifically, the     proposed study will investigate whether a novel parent mediated social skills program (Social     SUCCESS), which provides parent training in conjunction with a social skills group     intervention, will result in more frequent initiations during play with typically developing     peers. Participants will include 50 children with ASD age 4:0 to 6:11 years. Children will be     randomly assigned to either Social SUCCESS (N=25) or waiting list (N=25). Treatment will be     provided for 8 weeks during a weekly 120-minute social skills group at Abilities United. The     study will evaluate the effects of Social SUCCESS on areas of core social deficit including     frequency of peer initiations using parent ratings, observational measures, standardized     questionnaires, and a social eye tracking task. Outcomes will be compared to a waiting list     control group. Findings will be disseminated through presentations and publications to aid     clinicians in providing more effective social skills treatment for children with ASD and to     enhance the scientific knowledge-base related to evidence-based social skills treatments.     This research designed with the goal of stimulating additional scientific inquiry in the area     of treatment for core social deficits in ASD and will provide a strong foundation for larger     scale grants to study motivation-based interventions to improve social functioning.   "
8438|NCT03175445|"     Sexual dimorphism analysis in Egyptian population by locating the mandibular canal using     cone-beam computed tomography: an observational cross sectional study   "
8235|NCT03178097|"     There are different methods for measuring cardiac output (CO) completely non-invasive, which     are used today. Two of these should be used in the study to examine the CO in an older group     of patients (> 65 years) undergoing major trauma surgery. The first method is the     esCCOTM-technology by Nihon Kohden, the second uses the Volume Clamped Method via a     finger-cuff by Nexfin Edwards life sciences. Both technologies work continuously and fully     non-invasive.      The measured data will be compared to established standard procedures like semi-invasive     pulse contour analysis using the Flotrac-Vigileo system. The study should answer the     following questions:        -  How accurate and precise are the non-invasive methods? How large is the percentage          deviation in comparison to the established standard?        -  Are there any limitations of measuring accuracy regarding the age of the patient?      The continuous hemodynamic monitoring of patients during surgery has recently changed from     invasive and semi-invasive methods to completely non-invasive technologies. The accuracy and     precision of this way of measuring cardiovascular parameters in comparison to the invasive     standard is still controversial. Especially for older patient with atherosclerotic alteration     of the blood vessels the utility of non-invasive monitoring systems is not shown yet. But     principally this group with a high level of comorbidity might profit notably from less     invasive procedures. This is the reason for the planed research.   "
8236|NCT03178084|"     A low CD4/CD8 ratio is considered a surrogate marker of immunosenescence and is an     independent predictor of non-AIDS-related morbidity and mortality. Given the strong clinical     implications the impact of different regimens on the CD4/CD8 ratio recovery needs to be     analyzed. The MERIT study is a completed a randomized, double-blind, multicenter phase     IIb/III study with an open-label extension phase (240-week follow-up) to assess the efficacy     of zidovudine/lamivudine in combination with maraviroc (MVC) or efavirenz (EFV) in     treatment-naïve patients. Anonymised patient level data of the MERIT trial to compare the     trajectories of the CD4/CD8 ratio of participants treated with maraviroc vs. efavirenz will     be used.   "
8237|NCT03178071|"     This expanded access study has being designed following a demand from the FDA, given the     increase in the number of request for single patient INDs for lorlatinib   "
8238|NCT03178058|"     In this study we would like to identify demographic and individual risk factors that place     parturients at a higher risk for postoperative nausea and vomiting (PONV) and itching     following administered neuraxial morphine for cesarean section. Our primary objective is to     develop a reliable predictive neuraxial morphine induced nausea and vomiting (NMINV) and     itching model.   "
8239|NCT03178045|"     The aim of this study is to understand and improve the experience of patients after surgery     by comparing two methods of following symptoms while the patient recovers at home.   "
8240|NCT03178032|"     Oncolytic adenovirus for pediatric naive DIPG, to be infused after tumor biopsy through the     same trajectory in the cerebellar peduncle.   "
8241|NCT03178019|"     Dipeptidyl peptidase 4 (DPP4) is a serine exopeptidase able to inactivate various     oligopeptides involved in inflammation, immunity and vascular function. Our aim was to     investigate the associations between constitutive levels of DPP4 activity and inflammatory     biomarkers, skin microvascular reactivity, gut peptides, insulin resistance indexes, heart     rate and blood pressure variability, and measures of adiposity in subjects with different     grades of glucose tolerance.   "
8242|NCT03178006|"     This project aims to establish the correlation between intestinal microbiota with     inflammatory biomarkers, intestinal morphology, vascular reactivity and degree of hepatic     fibrosis in patients with different degrees of glucose tolerance and body adiposity.   "
9135|NCT03166345|"     Platelets rich plasma is simple source of growth factors and cytokines that can regulate     endometrial growth for subgroup of thin endometrium women. It is an autologous source of this     enhancing factors; therefore, there os no risk of using it within the same participant.   "
8243|NCT03177993|"     Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected     tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program     supported by the World Health Organization (WHO), however scabies and STH are currently     managed on an individual level with symptomatic treatment as required.      In an attempt to reduce the prevalence of LF globally, research is being undertaken into     alternative, more effective treatment options. A recent study in Papua New Guinea     demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is     superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole)     used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite     no serious adverse events being observed, it is necessary to conduct further studies to     review the safety of this new triple therapy before it can be endorsed as an effective mass     drug administration (MDA) regimen for LF in endemic countries. Fiji's burden of LF, that has     been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal     site to obtain further efficacy and safety data of the triple therapy.      Ivermectin given to communities as MDA has been proven to be effective in reducing the     community prevalence of scabies. What is not known is the effects of one dose versus two     doses of ivermectin as MDA. This question will be reviewed within the design of the community     randomized study. The prevalence of impetigo in a community is linked to scabies and this     will also be reviewed. Ivermectin and albendazole are both effective individually against     STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been     studied. The effectiveness for the individual in the short-term and the community in the     longer-term will be reviewed.      In addition, the acceptability and feasibility of the new therapy in communities at risk of     these three diseases will be reviewed.   "
8244|NCT03177980|"     A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation     study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for     analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in     the NICU.   "
8245|NCT03177967|"     A randomized, controlled study to examine the effect of group treatment for insomnia (CBT-I)     in an outpatient clinic compared with waiting list and treatment-as-usual (sleep-hygiene     based educational course)   "
8280|NCT03177512|"     This study is testing the acceptability and feasibility of a highly interactive mobile     application (app) to promote accurate risk perception and increase HIV and sexually     transmitted infection (STI) testing and linkage to care among young men who have sex with men     (YMSM).   "
8296|NCT03177304|"     The National Institutes of Mental Health has identified the use of empirically based mental     health treatments (i.e., treatments with research supporting efficacy) as a priority, yet     there is a shortage of clinicians trained in these approaches. This study develops an on-line     therapist training program for Interpersonal Psychotherapy (IPT), a particularly     well-researched yet particularly little disseminated, empirically based treatment, in order     to facilitate wider dissemination of this approach.   "
8297|NCT03177291|"     The purpose of this study is to find out what effects (good and/or bad) Pirfenidone combined     with standard first-line chemotherapy will have on you and non-small cell lung cancer     (NSCLC). The investigational drug Pirfenidone is being combined with standard chemotherapy in     participants with advanced non-small cell lung cancer. Pirfenidone is approved to treat     idiopathic pulmonary fibrosis (IPF) but it isn't currently approved to treat non-small cell     lung cancer.   "
8246|NCT03177954|"     There is a need to improve the discharge process for patients with stroke, which has been     reported to be a particularly stressful time for patients. A Patient Oriented Discharge     Summary (PODS) meeting has been shown to be an effective approach for minimizing     discharge-related stress and fostering self-management skills in other patients being     discharged from rehabilitation into the community. The purpose of this study is to develop     and evaluate whether a PODS meeting can minimize stress around the discharge process and     improve patient satisfaction with this process. There are two main hypotheses regarding the     PODS program: 1) it will help in-patients with stroke understand key issues related to     knowledge required once discharged and 2) it will increase levels of self-efficacy in     in-patients with stroke. Potential subjects are encouraged to participate if they are a     Sunnybrook - St. John's Rehab admitted in-patient with a stroke diagnosis who are 18 years or     older and meet the following criteria: (a) fluent in English; (b) cognitively intact; and (c)     have minimal or no aphasia.The participant will be asked to answer some surveys 8-10 days     prior to discharge about their knowledge and confidence in managing their stroke.      The participant will then be asked to meet with a clinical staff member who will hold a     one-hour PODS meeting. In the meeting, a discharge plan will be created and given to the     patient that covers a number of topics that will be useful following their return to the     community. One day following the PODS meeting, the participant will be asked to answer the     same survey they completed prior to the PODS and again 3-5 days following discharge. If the     participant is interested they will be asked to undergo a brief interview to get their     feedback on the PODS Program. It is anticipated that about 20 people will participate in the     program with all 20 patients completing the surveys with 6 being asked to complete the brief     interview.      To the best of the investigators knowledge, there is little risk associated with this study.     Participants may become uncomfortable during the interview while discussing their     experiences. By participating in this study, patients will be provided with a chance to     gather information and learn problem solving and self-management skills prior to discharge.     It is the hope of this project that it can lead to a more effective approach in supporting     the transition from the hospital to the community for patients with stroke   "
8247|NCT03177941|"     The proposed study builds upon the success of our research program (STU00017005:     Interventions to teach melanoma patients skin self-examination and the continuation     STU0201983) designed to increase early detection of melanomas before they metastasize. This     study seeks to expand the use of our efficacious skin self-examination (SSE) training program     to first-degree relatives with automated support with reminders and the dermatologist     coaching about pictures of moles submitted by user. In 2015 there are more than 1 million     living melanoma patients in the United States (US), and almost 500,000 were age 40-60 years.     If each melanoma patient has 2.79 first-degree relatives (children, and siblings of melanoma     patients), then there are 2.79 million first-degree relatives and 1 million melanoma patients     or 3.79 million people at-risk to develop melanoma, who are predominantly non-Hispanic White.     A first-degree relative (FDR) is the parent, sibling or child of a melanoma patient. In 2015,     approximately 73,870 individuals in the US will be diagnosed with invasive melanoma and about     9,940 will die from the disease. People with a history of melanoma have 10 times greater risk     of developing a second new melanoma relative to the general population. A first-degree     relative of a melanoma patient (parent, child, sibling) has an 8 times greater chance of     developing melanoma. Early detection with surgical excision at an early stage when treatment     is usually more effective is the only proven curative strategy. Thus, enhanced surveillance     for melanoma patients and screening for their first-degree relatives, who have the same skin     type (skin that easily sunburns) and melanoma-risk habits (sunny vacations) as the melanoma     survivor, has the potential to detect melanomas in the early stages where treatment prognosis     is optimal. Indeed, several societies recommend routine screening by a physician for persons     with a family history of melanoma.   "
8248|NCT03177928|"     Myeloproliferative neoplasms are heterogeneous group of clonal hematopoietic stem cell     neoplasms with excessive proliferation of one or more of the erythroid, megakaryocytic, or     myeloid lineages and relatively normal maturation resulting in increased numbers of red     cells, platelets, and/or granulocytes in the peripheral blood. Constitutive tyrosine kinase     activation appears to be a common pathogenetic mechanism.   "
8249|NCT03177915|"     Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to     investigate if, and to what extent, hydro-dissection using 1% lidocain followed by Sodium     hyaluronate versus 40 mg of triamcinolone acetonide, ultrasonic guided   "
8359|NCT03176485|"     This is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the     tyrosine kinase pathway in the presence or absence of solar simulated light exposure.      A maximum of 45 subjects will be accrued into the overall study we anticipate approximately     25 patients in the Raf inhibitor group and 10 patients each into the Tyrosine Kinase and MEK     inhibitor arms of the study.   "
8250|NCT03177902|"     Breast cancer is one of the most common cancers in China. Even though advances in the field     of breast cancer therapeutics, chemotherapy remains the mainstay therapeutic modality. The     cytotoxic therapies are generally associated with some immediate or otherwise delayed side     effects, such as adverse effects on gastrointestinal, hepatic, renal and hematological     systems. The effect of chemotherapy on endocrine system, however, is comparatively less     envisaged. Several epidemiological studies show a positive association between plasma thyroid     hormones levels and breast cancer risk. Thyroid dysfunction is emerging as a variably common     endocrine toxicity of several anticancer drugs. Due to the scarcity of data on the     functioning of thyroid gland during chemotherapy in a large scale group, the present study     was aimed to investigate the incidence of thyroid abnormity in Chinese women with newly     diagnosed breast cancer, and also the effects of chemotherapy on thyroid gland functions or     structure in these breast cancer patients undergoing at least four cycles of chemotherapy.   "
8251|NCT03177889|"     Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with     limited therapeutic approaches. From the perspective of traditional Chinese medicine,     congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or     mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat     trapping in the phlems, congestion of wind evils and stagnation of blood. Symptomatic     treatment may be effective and safe for ameliorating respiratory symptoms and hindering     disease progression of bronchiectasis. Here, the investigators have explored the Lung     Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling     the wind evil in patients with bronchiectasis. The investigators sought to conduct a     multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD     on clinically stable bronchiectasis.   "
8252|NCT03177876|"     twenty recruited patients indicated for sinus augmentation and immediate implant placement     will be divided into two groups (10 in each of the two groups), to compare bone formation and     implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite     Nano particles [Nanostreams] or augmentation with graft less tenting technique with     simultaneous implant placement.   "
8281|NCT03177499|"     Portal pressure gradient (PPG) above 12 mmHg after transjugular intrahepatic portosystemic     shunt (TIPS) increases the risk of portal hypertension complications. Currently, a PPG     reduction <12 mmHg after TIPS is the most consistent threshold associated with almost     complete protection from variceal bleeding and ascites. However, the measurement of PPG     requires an invasive procedure. A recent study investigated the variations in PPG     measurements collected at different time points after placement of TIPS and demonstrated that     a time point of at least 24 hours after which PPG values were best maintained (early PPG). It     is of great clinical value to propose that an immediate PPG measurement fail to accurately     identify the risk of decompensated event. And early PPG would change the decision making for     re-intervention or not. However, the repeated invasive examination is extremely difficult to     follow in clinical practice worldwide. The prospective multicenter trial aims to assess the     diagnostic performance of a virtual imaging-based early portal pressure gradient (vePPG)     (investigational technology) from CT angiography and Doppler ultrasound with invasive early     PPG measurement as reference. The study participants with portal hypertension will be     prospectively recruited at 10 high-volume liver centers in China.   "
8253|NCT03177863|"     In the Swedish organised cervical screening program precursors of cervical cancer are     detected and treated. Most precursor lesions detected by screening heal spontaneously. Those     who progress do it slowly. There are three levels from light; CIN1, moderate; CIN2 to severe;     CIN3. Women with CIN3 are always treated, regardless of age, according to current clinical     guidelines. Women with CIN2 who are below the age of 25 years are offered active expectance     for up to two years because there is good evidence that they will spontaneously heal their     lesions (regression) in 40-70% of the cases during that time.      Method of treatment is today an excisional procedure of the cervix most often by Large loop     excision of the transformation zone (LLETZ/LEEP) Treatment increases the risk of premature     birth in a future pregnancy. In 2015 about 1800 excisional procedures of the transformation     zone of the cervix were performed in the Västra Götalands regionen (VGR) om Sweden. The     average age of first-time mothers in Sweden is rising and in 2014 it was 29 years. Postponed     childbearing raises the question whether it is possible to refrain from surgery even for the     group of women over 25 years old, with proven CIN2. Existing studies suggest that cure of     CIN2 in the age group of and above 25 takes place in the same extent as under 25 years of     age.There is lack of evidence concerning clinical follow-up.      In a prospective multicenter clinical cohort study (observational study) with careful     monitoring, the investigators will examine what proportion of CIN2 changes regress     spontaneously within two years in women, 25-30 years old, and if human papillomavirus (HPV)     type 16 may can be a marker for poor regression in this group. Instead of LLETZ, active     expectance is offered to women this age with CIN2 in five gynecological clinics in VGR. The     study protocol includes gynecologist visits every 6 months for two years, including cytology,     colposcopy and directed biopsies of the cervix. Power calculation shows 160 women needs to be     included, which is expected to occur within one year from the start.   "
8254|NCT03177850|"     In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)     vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.   "
8255|NCT03177837|"     In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)     vs. placebo on exercise performance at altitude in patients with COPD.   "
8256|NCT03177824|"     The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal     outcomes in women with fetal growth restriction.   "
8257|NCT03177811|"     In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)     vs. placebo on postural control at acute altitude exposure in patients with COPD.   "
8258|NCT03177798|"     The overarching goal of this study is to determine the role of chronic kidney disease and the     activation of the kallikrein-kinin system during hemodialysis on the development of     mitochondrial dysfunction; the investigators will measure mitochondrial function using the     gold standard method, 31-phosphorus magnetic resonance spectroscopy.      The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial     dysfunction in patients undergoing hemodialysis. The investigators will first perform a     randomized, placebo-controlled, double-blind, cross-over study measuring the effect of     Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.   "
8259|NCT03177785|"     This study aims to test the efficacy of the EverydayMatters Multiple Sclerosis (MS) program     for individuals age 45 or older living with multiple sclerosis. The program involves a 6-week     telephone-delivered program to promote resilience and happiness for individuals living with     MS.   "
8360|NCT03176472|"     This is a randomized, double-blind, parallel group clinical study of up to 450 patients     designed to evaluate the safety and efficacy of ricolinostat for Diabetic Neuropathic Pain     (DNP).   "
8261|NCT03177759|"     This is a prospective evaluation to determine the effectiveness of the Prostate Cancer     Supportive Care (PCSC) Program's group therapy program, Living with Prostate Cancer (LPC).     LPC is an intervention which utilizes a small group format (5-7 participants with 2 leaders     and a paraprofessional counselling student) to understand and learn how to manage emotional     responses, depressive symptoms, and life stressors associated with prostate cancer. Data for     this evaluation will be derived from a focus group (at 3 months) and self-report     questionnaires that participants will complete immediately prior to the intervention,     immediately following the intervention and at 3, 6, and 12-months post-intervention.   "
8262|NCT03177746|"     The purpose of this study is to evaluate the safety and efficacy of Dapoxetine/Tadalafil     30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile     dysfunction.   "
8263|NCT03177733|"     This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF     block) for the anesthesia of the intercostal nerves anterior branches and assesses the     association of the serratus block with a PIF block for the breast surgery.      To obtain a correct prospective clinical trial completion we have to begin a new series of     inclusion.   "
8264|NCT03177720|"     The investigators will determine the difference of pharmacokinetics of ciprofloxacin and     imipenem between healthy volunteers and intensive care patients suffering from pneumonia in     plasma and at the target site - lung - using bronchoalveolar lavage. As additional aspect the     feasibility of combining microdosing of C14 ciprofloxacin with microdialysis, saliva sampling     and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and     macrodose.   "
8265|NCT03177707|"     With improvements in detection and treatment of prostate cancer (PCa), more men than ever are     living with side effects from PCa treatment; most distressingly, treatment side effects     include problems with sexual functioning (e.g. erectile dysfunction, climacturia,     inorgasmia). This study aims to develop a mindfulness-based group treatment for couples with     sexual functioning complaints post-PCa treatment. Couples will be invited to a four-session     mindfulness-based treatment group. Pre- and post-treatment outcomes (e.g., distress, sexual     functioning/enjoyment, relationship satisfaction, treatment adherence) will assess     feasibility and effectiveness of this novel treatment for couple's sexual lives after PCa.   "
8282|NCT03177486|"     Patients with coronary artery disease (CAD) were enrolled. CAD was diagnosed by coronary     angiography which also resulted Syntax score. Images of left and right ears were captured by     a digital camera. Frank score of each patients was calculated based on characteristics and     numbers of wrinkles of the earlobes. Statistic analysis were carried out to analyze the     correlation between Frank Score and Syntax Score.   "
43217|NCT02719990|"     Open-label extension study to evaluate the safety of long-term twice-monthly administration     of somavaratan in adults with Growth Hormone Deficiency (GHD).   "
8266|NCT03177694|"     Aging of the population is dramatically increasing the number of hospitalized patients, with     the consequent challenges of limited medical personnel and resources in hospitals. Wireless     technologies that create highly connected healthcare environments are developed to help     hospitals address these issues, once these technologies are perfectly integrated in the     hospital environment with respect to IT infrastructure for big data storage. Such devices     have proven remarkable efficiencies in monitoring patients with high patient safety, data     accuracy and security, which are essential to provide high quality patient care, reduce     health-related costs and optimize the management of high numbers of patients.      Cough is the most common condition that results in a visit to the physician. Often coughs are     benign, but sometimes can be the sign of exacerbations of a chronic respiratory disease.     Exacerbations are defined in the Global Initiative for Chronic Obstructive Lung Disease     (GOLD) document as an acute event characterised by a worsening of the patient's respiratory     symptoms that is beyond normal day-to-day variations and leads to a change in medication. It     is assumed that, if coughs were remotely monitored, hospitals might be unburdened, patients     would be empowered to self-manage their health, and that prevention of serious respiratory     diseases might be facilitated, thus improving health outcomes. Unfortunately, remote     monitoring for cough that rely on self-reporting is impractical, as patients do not record     data very reliably. On the contrary, a bed sensor under the mattress connected to a medical     data analysis platform might monitor patients' micro-movements at night and alert the medical     staff as soon as there is a cough exacerbation.   "
8267|NCT03177681|"     The goal of this clinical research study is to learn if probiotics found in yogurt can help     to decrease gastrointestinal (GI) symptoms in cancer patients. Probiotics are live bacteria     and yeast that help with many of our functions and may help digestive problems. Researchers     also want to learn if the bacteria in your stool change as your symptoms change while eating     yogurt.   "
8268|NCT03177668|"     The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110     intravenous administration in patients with malignant pleural mesothelioma and to     preliminarily examine the anti-tumor effect of YS110.   "
8269|NCT03177655|"     This single-center interventional study quasi-randomly allocated patients to a guided imagery     or control intervention (positive journaling). Data were analyzed with treatment allocation     masked.   "
8270|NCT03177642|"     The purpose of this research is to investigate multiple facets of non-traumatic and traumatic     orthopaedic health issues. Studies under this protocol will investigate a variety of research     questions concerning traumatic and non-traumatic health issues in the Orthopaedic Hand and     Upper Extremity Service.   "
8271|NCT03177629|"     The purpose of this study is to determine the efficacy of H. pylori eradication for the     treatment of chronic or persistent immune thrombocytopenic purpura (ITP) patients with     moderate thrombocytopenia. This is a multi-center, open label, prospective randomized phase     IIl study.   "
8272|NCT03177616|"     This pilot study evaluates the addition of chiropractic treatment to conventional     neurological care in the treatment of migraine headaches in adult women. Half of the     participants will receive 10 chiropractic treatments in addition to their usual care over a     14 week period, while the other half will continue their usual medical care alone, as     prescribed by their physician during that time period.   "
8369|NCT03176355|"     30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with     intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.   "
8273|NCT03177603|"     GSK2586881, a purified intravenous (IV) formulation of soluble recombinant human Angiotensin     Converting Enzyme (rhACE2) is being investigated as a treatment for PAH. This GlaxoSmithKline     (GSK) study will evaluate the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) of GSK2586881 in subjects with PAH. This open-label, dose-escalation     study will comprise of 4 separate groups based on the planned dose range, and subjects in     each group will be administered a single dose of GSK2586881 ranging between 0.2, 0.4, 0.8, or     1.2 milligram per kilogram (mg/kg) via IV route. Dose escalation will occur after 4 subjects     have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to     24 hours post dose has taken place. A maximum of 27 subjects will be included in the study     and the total duration of the study will be up to a maximum of 59 days.   "
8274|NCT03177590|"     The purpose of the JEMImE project is to create a serious game to help children with Autism     and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.      The objective of this study is to record facial and vocal emotional productions in children     with autism and PDD in order to create an algorithm for the recognition of facial emotional     expressions implemented in the serious game JEMImE.   "
8275|NCT03177577|"     To determine the effect of first dorsal interosseus (FDI) strengthening in patients with     thumb carpometacarpal (CMC) osteoarthritis.   "
8276|NCT03177564|"     This study aims to investigate the feasibility of a driving pressure limited mechanical     ventilation strategy compared to a conventional strategy in patients undergoing one-lung     ventilation during Video-assisted thoracoscopic lobectomy.   "
8277|NCT03177551|"     This is an observational, prospective (study following participants forward in time),     multi-center (study conducted in more than 1 center) study to identify the risk factors, then     develop and validate the predictive Nomogram of metastatic castration-resistant prostate     cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving     androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3     year. Participants will primarily be evaluated for achieving biochemical or radiological     progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum     testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine     will be monitored throughout the study.   "
8278|NCT03177538|"     In an opened randomized study of women undergoing in vitro fertilization with expected     suboptimal response to controlled ovarian stimulation (Poseidon Group 2b) investigators will     examine clinical efficacy and safety of two stimulation protocols: Corifollitropin alfa     (Elonva) in combination with menotropin (Merional) versus Follitropin alfa and lutropin alfa     (Pergoveris).   "
8283|NCT03177473|"     This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator     on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. All     participants will wear the bone growth stimulator every day for 4 hours/day for 6 months.   "
8298|NCT03177278|"     This is a single-center, open label, non-randomized metabolism, excretion, and mass balance     study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.   "
8285|NCT03177447|"     Background: Early palliative care (EPC) is recommended but rarely integrated with advanced     heart failure (HF) care. This pilot study engaged patients and family caregivers to study the     feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture,     Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers).      An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart     Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical     centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person     palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls.     Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom,     health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models     were used to assess baseline to week 24 longitudinal changes. The intervention was tailored     to rural, older adults (age≥65) with advanced HF in reducing HF morbidity and improving     patient and caregiver QOL and quality of care.   "
8286|NCT03177434|"     Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of     functional constipation in children aged 6 months to 6 years. The basis of assessment is to     compare the number of commissioned stools (more than three stools per week) and stool     consistency according to the scale of Bristol, in children taking Dicopeg Junior and children     treated with lactulose. Childrens who meet the inclusion criteria will be randomized to one     of two groups, in which the treatment will be as follows for 12 weeks:        1. The first group - Dicopeg Junior (max. in 2 doses) in a dose of:             -  weight up to 8 kg - 1 sachet per day             -  weight 8 - 12 kg - 2 sachets a day             -  weight 12 - 20 kg - 3 sachets a day             -  weight> 20 kg - 4 sachets per day,        2. The second group - Lactulose at 2 ml / kg / day (in two doses). Preparations: Dicopeg          Junior and Lactulose will be administered orally for the duration of the study (12          weeks).   "
8287|NCT03177421|"     The objective of this study is to use health information technology to implement and evaluate     a counseling recommendation for children who suffer from problematic sleep associated with     bedtime media use. Participants will be randomized by clinic to be screened for basic sleep     concerns and receive appropriate counseling, or to be screened for sleep concerns and media     use, and receive appropriate counseling.   "
8288|NCT03177408|"     This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive     patients. HMGB1 level were tested in all patients, and diastolic function determined by     echocardiographic.   "
8289|NCT03177395|"     Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC     treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC     treatment is initiated before 24hours post POD.   "
8340|NCT03176732|"     Hypertension is a common consequence of obstructive sleep apnea (OSA). However, not all     individuals with OSA have hypertension and there are major individual differences in blood     pressure response to positive airway pressure treatment of OSA. This project is focused on     determining the basis of these individual differences in blood pressure response to OSA and     will evaluate the possible underlying reasons for these differences. The results will help     clinicians to know whether or not to expect a reduction in blood pressure (BP) to OSA     treatment in a given patient and thereby personalize patient management.   "
8290|NCT03177382|"     Purpose:To compare the efficacy and the safety of total neoadjuvant chemotherapy + TME with     standard neoadjuvant concurrent chemoradiotherapy + TME + adjuvant chemotherapy for locally     advanced rectal cancer patients with high risk factors of recurrence.      Evaluation indexes: (1) the primary evaluation index: disease-free survival (disease free     survival, DFS); (2) the secondary evaluation indexes: pathological complete remission rate     (pCR), the 3 year overall survival (overall survival, OS); R0 dissection rate; distant     metastasis free survival (DMFS); local recurrence free survival rate (LRRFS); tumor     regression grade (TRG, tumor regression grade) and the adverse reaction rate during the     chemotherapy, the operation safety index; quality of life; psychological and cognitive     effects, assessment of nutritional status.      Safety evaluation indexes: including all adverse events observed during the experiment.      Number of patients: 458 cases Study design: patients will be randomly assigned into the total     neoadjuvant treatment group (experimental group, TNT) and neoadjuvant concurrent chemotherapy     group (control group, CRT) in the ratio of 1: 1. The patients of experimental group will be     given 1 cycle of induction CAPOX (Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2, bid,     d1-14) prior to radiotherapy. Then pelvic IMRT/VMAT (50-50.4Gy/25-28f) and two cycles of     concurrent chemotherapy (Oxaliplatin 130mg/m2, d1, d 22, Capecitabine 825mg/m2, bid, 5d/w,     25-28d) are performed. And three cycles of consolidation chemotherapy (CAPOX) are delivered     after concurrent chemoradiotherapy. Total mesorectal excision (TME) is performed after     completion of the whole neoadjuvant treatment. The patients of control group will receive     standard concurrent neoadjuvant chemoradiotherapy with capecitabine (825mg/m2, bid, 5d/w)     followed by TME 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients are     treated with another 6 cycles of CAPOX.      Schedule: Investigators plan to finish the study in 4 years and write the related work within     2 years after the completion of this study.   "
8291|NCT03177369|"     Staphylococci represent the first etiologic agents of bone and joint infection (BJI), leading     glycopeptides use, especially in case of methicillin-resistance or betalactam intolerance.     Teicoplanin may represent an alternative to vancomycin because of its acceptable bone     penetration and possible subcutaneous administration. Various studies have shown that     teicoplanin pharmacodynamic profile was superior compared to vancomycin regarding bone     diffusion. Few studies have investigated the use of teicoplanin in BJI, particularly through     subcutaneous administration.      The aim of this study assesses the efficacy and tolerance of teicoplanin in S. aureus BJI,     especially focusing on subcutaneous use. This study is a retrospective single-center     observational cohort study (2001 to 2011) including all consecutive patients managed at our     institution receiving teicoplanin as part of S. aureus BJI treatment.   "
8292|NCT03177356|"     20 recruited patients indicated for immediate implant placement in mandibular molar patients     are divided into 2 groups each group contain 15 patients, one group assigned for placement of     bovine bone after molar extraction and immediate implant placement, while the other group we     use Platelet-rich fibrin as space filling material.   "
8293|NCT03177343|"     Staphylococcus aureus represents the leading pathogen implicated in bone and joint infection     (BJI), usually requiring prolonged combination antimicrobial therapy, which may be     particularly challenging in the case of MDR bacteria and/or for patients with multiple drug     intolerance. In the absence of new well-tolerated oral antistaphylococcal drugs, older     antibiotics must be considered, such as the pristinamycin.      However, pristinamycin is not currently licensed for treatment of staphylococcal BJI and lack     of clinical data prevents it from being considered as a reliable alternative therapeutic     option in current guidelines.      The aim of this study is to evaluate pristinamycin (efficacy and tolerance) in the treatment     of MSSA bone and joint infection (BJI).   "
8294|NCT03177330|"     Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock     patients with intra-abdominal infections. Because of the concerns of postoperative bleeding,     physicians may hesitate to use anticoagulation in patients with septic shock within a few     hours after an abdominal operation. We developed a heparin dosing score protocol for heparin     dosage adjustment. The purpose of the study is to examine the safety and efficacy of the     heparin dosing score protocol.   "
8295|NCT03177317|"     Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in     elderly patients receiving moderate emetogenic chemotherapy   "
8337|NCT03176771|"     The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once     daily for the treatment of Tardive Dyskinesia (TD) symptoms.   "
8299|NCT03177265|"     Tobacco-related diseases account for a significant portion of all VA healthcare costs and are     a detriment to the health and quality of life of our Veterans. Despite progress in     instituting tobacco screenings and treatment referral, most Veterans still do not receive the     most effective strategy to help them quit smoking - pharmacotherapy combined with behavioral     coaching. This study builds on findings from population health and mobile interventions to     help more Veterans receive evidence-based tobacco treatment. The investigators propose to     test the effect of two types of text messaging in combination with telephone cessation     counseling: 1) pre-counseling text messages to increase enrollment in counseling, and 2)     ongoing texts for those who start counseling that provide appointment reminders and support     between sessions to increase adherence to counseling. This study supports multiple goals of     the VA's Blueprint for Excellence. Results will directly inform decision-making and     population-based care models for tobacco treatment.   "
8300|NCT03177252|"     Making sure the heart rate and or the blood pressure [called hemodynamic instability] during     surgery is stable, setting up for a rapid postoperative recovery, and ensuring that patients     have adequate pain relief are some of the important goals of neurosurgical anesthesia. Scalp     block anesthesia [injection of a numbing agent into the area of the scalp where the incision     will be] together with general anesthesia is used to achieve these goals. There has been some     research on whether or not scalp block improves patient recovery and pain management, but the     studies have not be large enough to say for certain. This is true even though scalp block is     used with almost every patient that is having brain surgery. The investigators propose to     determine if scalp block in combination with asleep anesthesia is better than asleep     anesthesia alone in patients who are having brain surgery for tumors in the cerebral area of     the brain.   "
8354|NCT03176550|"     Few patients recover full hand dexterity after an acquired brain injury such as stroke.     Repetitive somatosensory electrical stimulation (SES) is a promising method to promote     recovery of hand function. However, studies using SES have largely focused on gross motor     function; it remains unclear if it can modulate distal hand functions such as finger     individuation. The specific goal of this study was to monitor the effects of SES on     individuation as well as on cortical oscillations measured using EEG, with the additional     goal of identifying neurophysiological biomarkers.   "
8407|NCT03175861|"     Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography     (PET-CT) parameters predictive of tumor response and local control   "
8408|NCT03175848|"     This is a prospective, single arm, phase II trail to assess the effect of primary lesion     radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic     chemotherapy.   "
8301|NCT03177239|"     This study aims to evaluate the safety, tolerability and effectiveness of new treatments for     kidney cancer called Nivolumab and Ipilimumab. The study is in two parts; in the first     instance patients receive nivolumab alone. If this treatment is not effective patients may     move onto the second part of the trial, where they receive nivolumab + ipilimumab. There is     no placebo.      The reason to offer one treatment alone, followed by two treatments together is that it is     thought that the double treatment may have more side-effects, but also may be effective in     people in whom the single first treatment (nivolumab alone) has not helped.      Nivolumab and ipilimumab are experimental treatments. This means that they are not an     approved treatment for non-clear cell kidney cancer in Australia.      The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab     (also known as Opdivo or BMS-936558) and Ipilumumab (also known as MDX-010 or Yervoy).     Nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to     see if they will allow the body's immune system to work against tumour cells. The immune     system is the body's defence against cancer, bacteria and viruses. The effectiveness of     nivolumab and ipilimumab in cancer of the kidney will be assessed by measuring the size of     patient tumours via CT scans.      Nivolumab and ipilimumab have been used alone or in combination in many other cancers, and     are licenced for use in other cancers like advanced melanoma and bladder cancer in Australia.     They have not been tested in people with non-clear cell kidney cancer.      About 85 participants with non-clear cell kidney cancer are expected to participate in this     study, from Australia and New Zealand.      This research study has been initiated by Dr. Craig Gedye, is being conducted in     collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in     Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials     Group Pty Ltd. Bristol Myers Squibb (BMS) is supplying the study drugs and grant funding for     this research.   "
8302|NCT03177226|"     Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of     applied nominal electrical stimulation parameters given to premature ejaculation (PE)     patients in order to prolong the ejaculatory latency time which will eventually increase the     quality of their sexual life.   "
8303|NCT03177213|"     Pemphigus is severe antigen derived autoimmune bullous skin disorder, the word pemphigus is     derived from the Greek word pemphix  which means blister . Two main clinical variants are     known pemphigus vulgaris (PV), and pemphigu foliaceus (PF). (Zenzo .et al., 2015).   "
8304|NCT03177200|"     Background In view of expected growth of the older population in Singapore in the next     decades, the volume and complexity of needs for health care services is expected to increase,     which amplifies stress on the current healthcare system. One approach to addressing this     challenge is to consider service utilization in relationship to needs based on population     segmentation and to plan and evaluate new services in light of unmet needs.      Specific Aims and Hypotheses Primary Aim 1: To establish health and social service (HASS)     norms for population segments as defined by the Simple Segmentation Tool (SST) via a     modified-Delphi methodology.      Primary Aim 2: To evaluate the concordance between the types of HASS that patients in each     population segment actually utilize versus the types of HASS normatively defined for each     population segment over a 3-month period from the point of hospital discharge.      Primary Hypothesis: The concordance between the actual utilization of different types of HASS     versus normative HASS is not better than fair.      Secondary Aim: To assess the association between concordance of normative HASS and incidence     of adverse outcomes which includes emergency department visits, unplanned hospital     readmissions, nursing home placement, and all-cause mortality over a 12-month period from     point of hospital discharge for all population segments.      Secondary Hypothesis: Patients with disagreement between normative HASS and actual     utilization of HASS will have a higher incidence of adverse outcomes.      Methodology The investigators will use a modified-Delphi methodology to develop HASS norms     and conduct a follow-up study of inpatients to evaluate the concordance between the types of     HASS utilized and norm HASS, and to evaluate the association between this concordance and     adverse outcomes in each population segment.      Significance to Health Services Delivery The transformation of the health care system to     effectively meet growing needs in a patient-centric way requires practical tools for     population planning and program development. The norms and evaluation approaches developed     here will guide clinical and public policy decision makers in prioritizing population needs,     and thus contribute to tangible improvements in health services delivery, patient care and     health outcomes for an aging Singapore population.   "
8305|NCT03177187|"     ACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069,     administered in combination with enzalutamide, in patients with metastatic castration     resistant prostate cancer(mCRPC). The investigators will be investigating the safety and     toxicity of the combination.   "
8306|NCT03177174|"     This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy     combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.   "
8307|NCT03177161|"     A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their     views on their own health or the impact of healthcare they have received on their health and     quality of life (RCN, 2011). The benefit of PROMS is that they gather information from the     patient's perspective, which offers great potential to improve the quality and outcomes of     health services (Department of Health 2011).      There is a PROM (the PROMIS-10 Global Health) and a number of extra questions that are     recommended for use in people who have had a stroke by the International Consortium for     Health Outcomes Measurement, but the best way of delivering these questions for stroke     survivors is unknown.      At present, the NHS in England, Scotland and Wales are required to offer every stroke     survivors a 6 month post stroke follow-up appointment. Currently, the information collected     at the 6 month review is not from the patient's perspective and the best method of collecting     this information has not been established. The Sentinel Stroke National Audit Programme     (SSNAP) which is led by the Royal College of Physicians in London promote the 6 month     follow-up assessment. SSNAP recognise that currently 4 different methods of 6 month follow-up     appointment occur. The current methods in use are face-to-face assessment, telephone     interview, online questionnaire or postal questionnaire.      The aim of this research is to understand if there is a difference between these 4 methods of     delivering these questions in people who have had a stroke.      As part of the 6 month review this research study will assess the response rate for 15     Patient Reported Health Status questions across the 4 recognised methods of delivery;        -  Face-to-Face        -  Telephone        -  Online        -  Post      To conduct this research study a sample of 808 stroke survivors will be asked to take part in     the research. From these 808 people, 202 participants will be randomly assigned to each     method of administration (Face-to-Face Interview, Telephone Interview, Postal Questionnaire     and Online Questionnaire).      The questionnaires received by the research team will not record any personally identifiable     information. The data will then be utilised by the researchers for statistical analysis in     order to identify, which method of the 4 methods of administration, under investigation, is     the most acceptable for stroke survivors. The conclusions of this research will inform the     roll-out of the most appropriate method of delivering the 6 month stroke follow-up review for     stroke survivors.   "
8308|NCT03177148|"     In this cluster randomized effectiveness trial, pediatric primary care practices will be     recruited from the American Academy of Pediatrics' national Pediatric Research in Office     Settings (PROS) practice-based research network, as well as the client database of the     Physician's Computer Company (PCC) - an Electronic Health Record (EHR) vendor. We will     recruit 18 practices. 9 practices will be randomized to the Intervention arm and 9 practices     to Usual Care. Intervention arm practices will select 1-2 pediatric clinicians to receive     in-person training in Motivational Interviewing (MI), behavioral therapy, billing and coding,     and study procedures. Usual Care practices will select 1-2 pediatric clinicians to receive     billing / coding and study protocol training only, via telephone and webinar; they will be     offered in-person MI training at the close of the trial. Around 316 parents of overweight or     obese children (BMI > 85th percentile for age and gender) between 3 and 8 years of age at     baseline that are patients of participating Intervention arm clinicians will be enrolled.     Over 24 months, these parents may receive up to 4 in-person, MI-based counseling sessions     with a trained pediatric clinician and up to 6 telephone counseling sessions with an     MI-trained Registered Dietician (RD). There will be no study-specific contact with parents or     their children in Usual Care practices during the trial - they will continue to receive usual     care. EHR and billing data for all 3-8 year old children within all participating practices     will be extracted by PCC to permit determination of the effectiveness of the intervention     versus usual care on change in BMI z-score among 3 groups: 1) all eligible children in the     Intervention arm), 2) all eligible children whose parent actively participates in the trial ,     and 3) all 3-8 year old children in all participating practices.   "
8356|NCT03176524|"     This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in     subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a     sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon     (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®,     each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.      Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD)     assessments will be carried until 4 hours. Safety will be assessed during all the trial     period.      The total trial maximum duration for the individual subject will be up to 10 weeks.   "
8309|NCT03177135|"     This is a Prospective study to demonstrate that the AMNIOSENSE Blue pad can reliably rule in     or rule out amniotic fluid leak as a cause of vaginal wetness in pregnancy, thus, can be     adopted by hospitals as an amniotic fluid leak detection tool, and can be recommended by care     providers for use in a home usage setting.      Study Group 1: Women attending the triage / delivery room with unidentified will be provided     with an AMNIOSENSE Blue pad to use in hospital until they notice any wetness prior to a     clinical assessment as per hospital standard procedure.      The clinician performing clinical diagnosis tests for amniotic fluid leak detection,     according to the hospital standard procedure will be at all times blinded to the results of     the AMNIOSENSE Blue pad.      Study Group 2: Women attending the obstetrical antenatal clinic for a routine antenatal visit     > 36+0, and has not been referred for further assessment in triage/delivery unit by the     physician will recruited to this study group (Study Group 2). Before leaving the antenatal     clinic, they will be given one AMNIOSENSE Blue pad to use at home when vaginal wetness is     experienced or in any case when they suspect that they have amniotic fluid leakage. The     participant will be instructed to arrive at the hospital within 2 hours of applying the     AMNIOSENSE Blue pad, regardless of the test results (positive or negative), to have a     clinical diagnosis by the attending physician.   "
8310|NCT03177122|"     This is a prospective comparative randomized controlled study investigating the effect of     Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.   "
8311|NCT03177109|"     This is a single center, randomized control. Sixty eligible subjects will be recruited into 3     study treatment groups (n=20 per group) through computerized randomization. Subjects in group     1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2     with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and     protect, Dentsply). The subjects in the study will be evaluated for tactile and air-blast     hypersensitivity criteria at baseline, two and four weeks.   "
8312|NCT03177096|"     The implementation of a sensor of glycemia Enlite coupled with an insulin pump (Medtronic     Minimed 640G) is a therapeutic option that Hospital of Mulhouse can propose to the children     affected by type 1 diabetes. The glycemic rate detected by the sensor of continuous measure     of the glycemia is visible in real time on the pump and then the rate can be normalized. The     study will evaluate the impact of the continuous measurement of blood glucose on insulin pump     on child quality of life with type 1 diabetes aged 2 to 13 years old.   "
8313|NCT03177083|"     The primary objective of the study is to evaluate safety and tolerability as defined by the     frequency of the adverse events (AEs) of flu-like symptoms (FLS) [chills, pyrexia, myalgia,     and asthenia], injection site reactions (ISRs), and injection site reaction pain (ISR-P),     over 24 weeks of treatment (the active comparator period) with PLEGRIDY 125 μg subcutaneous     (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting     Multiple Sclerosis (RRMS).   "
8314|NCT03177070|"     The main aim of this project is to assess whether intravenous methylene blue can help     identify the ureters during open and laparoscopic (keyhole) surgery. The ureters are small     tubes that link the kidney to the bladder and, if not properly identified during surgery, may     be damaged.      Methylene blue has been safely given to patients for many years and it is fluorescent. It is     removed by the kidney and will therefore travel through the ureters. Methylene blue shines     brightly (becomes fluorescent) when viewed under red light.      This study aims to compare the ability of methylene blue with white light to identify the     location of the ureters during colorectal surgery. Recruitment will include 50 patients     undergoing colorectal surgery (25 for keyhole/laparoscopic, 25 for open procedures). Each     patient will act as their own control.      To detect the fluorescence, a special fluorescent laparoscope for keyhole surgery will be     utilised, and a wide-field camera will be used for open surgery.      The potential benefits of this procedure are to identify the ureters during surgery and     therefore prevent inadvertent damage to them      It is hoped that near infra-red light emitting from the ureters will be detected. This will     allow the surgeon to determine the anatomy of the ureters during the operation and avoid     inadvertent injury.      Funding source: Nuffield Department of Surgical Sciences, University of Oxford Recruitment     sites: Oxford University Hospitals NHS Trust.   "
8315|NCT03177057|"     This pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART)     project works in sun exposure and protection behaviors. Measuring how behavior tracking and     individually tailored messages affect risk behaviors in patients with skin cancer may help     doctors plan the best prevention plan and decrease national melanoma incidence and mortality.   "
8316|NCT03177044|"     The primary aim of the project is to investigate whether a behavioural training programme     improves troublesome bowel symptoms, that people with inflammatory bowel disease continue to     have, despite their disease being controlled by medication. The other aim is to determine if     there are factors which influence how well the training programme works.      People attending an Inflammatory Bowel Disease clinic in a tertiary hospital, with bothersome     bowel symptoms despite disease control, will be asked to join the study. This involves 2 to 6     sessions with a pelvic floor trained physiotherapist over a period of 6 months with further     follow up at 12 months..   "
8338|NCT03176758|"     Total knee arthroplasty may be conducted either under general anesthesia or spinal block.     previous studies have shown that spinal block leads to less complications. The investigators     aim to find whether post-operative pain is also diminished under spinal block compared to     general anesthesia   "
8317|NCT03177031|"     This post-marketing study is undertaken to compare the clinical effectiveness and safety of     two continuous ambulatory peritoneal dialysis produced by Fresenius Medical Care (FMC), i.e.     Stay Safe® (STS) that is produced by a plant in Germany and Stay Safe Link® (SSL) that is     produced in Malaysia. The study is an open labelled, randomised controlled trial where 434     patients in total will be randomised to either STS or SSL in a 1:1 ratio.   "
8318|NCT03177018|"     The main objective of this study is to assess if it is possible, at the end of endocardial     voltage mapping, to accurately collect intact cardiomyocytes and to isolate high quality DNA     allowing molecular testing of selected genes involved in arrhythmogenic right ventricular     cardiomyopathy/dysplasia .   "
8409|NCT03175835|"     The purpose of this study is to evaluate the drug interaction between CKD-519 and     rosuvastatin in healthy male subjects.   "
8319|NCT03177005|"     Approval for access is solely at CSL Behring's discretion and the following criteria must be     met for CSL Behring to consider access to experimental or unlicensed product:        -  The patient has an unmet medical need that is life-threatening, chronic or seriously          disabling, as defined by local regulations and applicable to the particular patient. All          treatment options available to the patient should have been explored and exhausted by          the physician, including participation in clinical trials.        -  The patient and caregiver must be informed of potential risks and benefits of receiving          the experimental therapy. The overall potential benefit should outweigh the combined          potential risks of the experimental medicine and the outcome of the illness or disease          itself. If approved, CSL Behring will provide treating physicians with risk information          wording for inclusion in the physician's informed consent form, which will outline the          risks of the experimental medicine. Treating physicians must share this information with          the patient through the informed consent process. Treating physicians must also agree to          participate in CSL Behring's safety monitoring and reporting requirements and follow FDA          safety reporting regulations.        -  Only medicines under active clinical development in the USA by CSL Behring will be          considered for early access. There must be sufficient clinical trial data on efficacy          and safety indicating a potential benefit greater than risks for the intended use and          dose.        -  Granting early access should not negatively impact or delay the ongoing development          program with the experimental medicine to support approval by FDA and other regulatory          authorities.        -  Adequate supply of the experimental medicine must exist to support both ongoing clinical          trials and approved expanded access until, and if, the product becomes commercially          available.      Only requests received from the licensed physician on behalf of the patient will be     considered. CSL Behring will assess the request against the above criteria. If these criteria     are met and the IRB/Ethics Committee and FDA approve access to the experimental therapy,     early access may be granted. US medicine importation requirements must also be met. The     patient's physician is responsible for the patient's ongoing care as well as all relevant US     federal and state legislations while the patient is receiving the experimental medicine     through early access. If approved the patient/caregiver must provide informed consent and the     treating physician must follow safety and monitoring requirements as defined by CSL Behring.      CSL Behring cannot provide a guarantee that expanded access will be available for every     experimental medicine. Even if such a program is offered CSL Behring cannot guarantee that an     experimental medicine will be available to a particular patient. The early access will cease     if clinical trials or regulatory assessment determines the product does not demonstrate a     positive risk benefit for patients. Once the experimental medicine is approved and     commercially available in the US, early access will no longer be available.   "
8320|NCT03176992|"     Two hundred & forty patients aged from 40 to 50 years - complaining of heavy menstrual     bleeding that is unresponsive to hormonal lines of treatment & requesting conservative     surgical approach- were randomized into 3 groups; group A (Surgicel group) in which 80     patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the     uterine cavity, group B (Thermal balloon ablation group) in which 80 patients underwent     thermal balloon ablation using bipolar radiofrequency electrical energy (Novasure), group C     (Endometrial resection group) in which 80 patients underwent transcervical Hysteroscopic     endometrial resection.All patients were followed up over duration of 18 months following the     procedure (at 3,6,12 & 18 months). Primary outcome included amenorrhea rates   "
8321|NCT03176979|"     This pilot clinical trial studies how well contrast enhanced spectral mammography works with     digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast     enhanced spectral mammography uses a special dye that is injected into the veins before     mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to     produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral     mammography with digital breast tomosynthesis may highlight areas of concern within the     breast in more detail than a standard mammogram and improve the accuracy of tumor size.   "
8322|NCT03176966|"     The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the     treatment of muscle cramps in cirrhotic patients.   "
8323|NCT03176953|"     Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and     having both disorders is associated with greater psychological and functional impairment than     having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is     sometimes less effective when individuals also have AUD. Anti-relapse medication appears     promising to improve the effectiveness of PE to help individuals reduce alcohol use and PTSD     symptoms and improve functioning. This study compares PE with and without topiramate, a     medication shown to both reduce drinking and PTSD symptoms, with the hypothesis that combined     PE and topiramate will be more effective than PE and placebo. The aim of this grant is to     improve treatment outcomes for Veterans with AUD and PTSD.   "
8324|NCT03176940|"     The purpose of this study is to evaluate the administration of single doses of 2-HOBA in     humans, with an escalation of doses that begins with the calculated Maximum Recommended     Starting Dose. This evaluation will assess tolerability to oral administration of 2-HOBA,     obtain pharmacokinetic data, characterize the 2-HOBA metabolic pathways, and determine the     relation of dose to prevention of formation of bi-functional electrophile adducts in blood.     Characterization of the metabolic fate of 2-HOBA will be supported by investigations that     evaluate metabolism in microsomes and cells.   "
8325|NCT03176927|"     There is a tremendous clinical need for a noninvasive technique that can assess gastric     electrical activity and would be repeatable without any exposure to radiation. Investigators     developed a new technique allowing to use noninvasive methods to assess bioelectrical     activity in the gastrointestinal system. This has enabled to characterize the normal and     pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG)     records. Primary hypothesis for this proposal is that analysis of gastric slow wave     uncoupling and propagation in multichannel MGG discriminates between normal and pathological     gastric electrical activity. Eventually, investigators envision this research leading to new     insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and     chronic idiopathic nausea that would inform clinical management of these debilitating     diseases.   "
8326|NCT03176914|"     This study modified and contextualized a community mobilization approach in a bid to find a     solution to reduce the high incidence and prevalence of child morbidity and mortality in     Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity     and mortality at community level by comparing the effect of the intervention to that of the     conventional community interventions.   "
8327|NCT03176901|"     The purpose of this study is to examine the feasibility of conducting a pilot randomized     controlled trial comparing mindfulness-based stress reduction with the health enhancement     program on symptoms of urinary urge incontinence in older adult women, and to establish     preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.   "
8355|NCT03176537|"     The aim of this study is to assess if hypogonadic men with periodontitis benefit from     testosterone replacement therapy before being submitted to periodontal treatment. Fifty     hypogonadic men (Total Testosterone <200ng/dL) will be recruited from the Clinics Hospital at     Federal University of Paraná and subjected to periodontal evaluation by a trained and     calibrated researcher. The subjects presenting with periodontitis (assessed by clinical     parameters) will be randomly allocated to testosterone replacement therapy (TRT) group or     placebo for 3 months. After that time, all patients will receive nonsurgical periodontal     treatment, which will be reassessed after 45 days. Clinical parameters (such as probing     depth, gingival and plaque index, clinical attachment loss, bleeding on probing), sub     gingival plaque and gingival crevicular fluid will be collected at baseline, just before     therapy and 45 days after therapy.   "
8328|NCT03176888|"     Treatment of cancer patients should not only involve removing the cancer, but should also     focus on maintaining good health and well-being and quality of life. This can be done by     offering patients suitable rehabilitation programmes. Previous research has shown that such     programmes need to involve exercise alongside other components, such as psychological     support. To date most studies have looked at the positive effects of moderate-intensity     exercise such as brisk walking, but this type of exercise is time-consuming and often not     done by many patients. Shorter-duration exercise routines consisting of repeated short     sprints have been found to improve general health just as well, but one of the most     time-efficient routines (termed 'reduced-exertion high-intensity interval training', or     'REHIT') has not been studied in cancer patients. REHIT involves 3 exercise sessions per     week, each only 10 minutes long. This makes it an ideal routine to combine with other     components of a cancer rehabilitation programme. The present study will determine whether     REHIT can improve important markers of health and well-being in newly diagnosed breast cancer     patients. To achieve this the investigators will recruit up to 30 patients and divide them     into a group who will do REHIT before and for up to 6 weeks after their cancer surgery, and a     control group who will receive standard care. Markers of health and well-being will be     measured at the start of the study, ~1 week after surgery, and ~7 weeks after surgery. Any     changes will be compared between the exercise group and the control group. If beneficial     effects are found with the REHIT intervention then this could be more widely implemented as     part of cancer treatment. This study is funded by Nuffield Health and will be performed in     Oxford, UK.   "
8329|NCT03176875|"     The primary objective of this study is to determine the efficacy of a novel enteral nutrition     (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of     remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the     standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients     to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD).      The hypothesis is that no significant difference in the remission rate between the novel EN     protocol with partial enteral nutrition (PEN) and standard protocol with EEN will be     observed.   "
8330|NCT03176862|"     This study aims to understand the onset an functional consequences of left ventricular     interstitial fibrosis in patients with chronic kidney disease (stage 2 to 5), as well as     assess whether transplantation results in a regression of cardiac fibrosis.Thus all patients     will undergo: 1) a cardiac magnetic resonance imaging (MRI) scan to assess cardiac function     and measure left ventricular interstitial fibrosis; 2) a cardiopulmonary stress     echocardiogram to understand the functional consequences of fibrosis and rule out any     underlying ischaemic heart disease; 3) a 24 hour holter monitor and electrocardiogram (ECG)     to assess whether these patients are at higher risk of arrhythmia.   "
8331|NCT03176849|"     Research has suggested that children with sufficient vitamin D levels undergoing     hematopoietic stem cell transplant (HSCT) have improved outcomes, including lower incidences     of infection and graft-versus-host disease (GVHD), as well as overall improved survival.     However, supplementation in children undergoing HSCT has shown to be a challenge using     standard or aggressive supplementation strategies. The overall objective of our study is to     determine the effectiveness of a single, high dose oral vitamin D at the start of transplant     followed by maintenance supplementation in children undergoing HSCT.   "
8332|NCT03176836|"     Li-Fraumeni Syndrome (LFS) is a cancer predisposition disorder in which most affected     individuals develop cancer during their lifetime. The majority of LFS patients carry a     mutation in a gene called TP53, whose normal function is to control cell growth and prevent     cells with damaged DNA from becoming cancerous. There is currently no way to determine when,     where or what type of tumour will develop. This project will use novel techniques utilizing     magnetic resonance imaging (MRI) to determine how sensitive they are at detecting very small     tumors and how specific they are in terms of distinguishing malignant tumors from benign     tumors.   "
8333|NCT03176823|"     The prevention of secondary brain injury is a primary goal in treating patients with severe     traumatic brain injury (TBI). Secondary brain injury results from tissue ischemia induced by     increased vascular resistance in the at-risk brain tissue due to compression by traumatic     hematomas, and development of cytotoxic and vasogenic tissue edema. While traumatic hematomas     may be managed surgically, cytotoxic and vasogenic edema with resulting perfusion impairment     perpetuates brain ischemia and injury. Animal models suggest that remote ischemic     conditioning (RIC) can reverse these effects and improve perfusion. Based on these findings     it is hypothesized that RIC will exert beneficial effects on TBI in man, thereby representing     a new therapeutic strategy for severe TBI.      Patients presenting to our institution suffering from severe TBI will be considered for     enrollment. Eligible patients will have sustained a blunt, severe TBI (defined by Glasgow     Coma Scale <8) with associated intra-cranial hematoma(s) not requiring immediate surgical     decompression, with admission to an intensive care unit and insertion of an intra-cranial     pressure monitor. Patients will be randomized to RIC versus sham-RIC intervention cohorts.     RIC interventions will be performed using an automated device on the upper extremity     delivering 20 cumulative minutes of limb ischemia in a single treatment session. The planned     enrollment is a cohort of 40 patients.      Outcomes of this study will include multiple domains. Our primary outcome will include serial     assessments of validated serum biomarkers of neuronal injury and systemic inflammation.     Secondary outcomes will include descriptions of the clinical course of each patient,     radiologic assessment of brain perfusion, and neurocognitive and psychological assessment     post-discharge.      If clinical outcomes are improved using RIC, this study would support RIC as a novel     treatment for TBI. Its advantages include safety and simplicity and, requiring no specialized     equipment, its ability to be used in any environment including pre-hospital settings or in     austere theatres. The investigators anticipate that TBI patients treated with RIC will have     improved clinical, biochemical, and neuropsychological outcomes compared to standard     treatment protocols.   "
8334|NCT03176810|"     The present study aims to demonstrate the superiority of optical coherence tomography     (OCT)-guided percutaneous coronary intervention (PCI) compared with Angiography-guided PCI.   "
8335|NCT03176797|"     Early diagnosis and treatment of liver fibrosis can repress or delay the development of     cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate     non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and     grading of liver fibrosis, so that patients can be treated in time. These techniques combined     could reach high diagnostic performance for detection of liver fibrosis, and could decrease     the number of liver biopsies.   "
8336|NCT03176784|"     This research will determine whether two highly promising modifications to varenicline     treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce     superior smoking outcomes when they are either used together or alone. Despite their promise,     the proposed modifications have never been experimentally evaluated relative to standard     varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence     regarding how best to help smokers quit, and thereby address the leading cause of preventable     mortality and morbidity related to cardiovascular and pulmonary diseases.   "
8341|NCT03176719|"     It has long been recognized that the positive effects of vaccination on childhood mortality     cannot be solely attributed to a decline in the disease targeted by the vaccine. These     so-called non-specific effects of vaccination have so far mostly been linked to mortality.     However, it has been suggested that non-specific effects may also effect morbidity and     nutritional status. This study aims to further explore the correlation between vaccination,     susceptibility to infectious diseases (particularly malaria and bacterial infections),     nutritional status and immunity.      With this prospective cross sectional study among healthy individuals in rural west-Africa we     aim to address several research questions at the same time. This study will assess the     influence of (time-point of) vaccination on morbidity, mortality and immune status among     healthy individuals in a rural sub-Saharan African setting. Secondly, to explore the     prevalence of subclinical malaria, iron deficiency anemia, sickle cell anemia and thallasemia     among a healthy rural sub-Saharan African population. And finally to assess normal     hemocytometry values among a healthy rural sub-Saharan African population.   "
8342|NCT03176706|"     To avoid iodine deficiency and its consequences in pregnant women and their offspring, women     should reach a sufficient iodine intake long before conception. To monitor iodine status,     median urinary iodine concentration (UIC) is widely used in pregnant women (PW).     Thyroglobulin (Tg) us another marker used to assess iodine status . In this study, urine     samples as well as dried blood spots will be collected to measure UIC and Tg (as well as     other hormones to define thyroid function) in PW. The results shall be used to reassess the     threshold which defines iodine status in PW according to UIC.   "
8343|NCT03176693|"     Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires     preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby     reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a     non-selective alpha blocker that is significantly more expensive and is associated with     increased adverse effects in comparison with selective alpha blockers such as doxazosin.     Retrospective studies show minimal differences in hemodynamic instability and no differences     in postoperative morbidity and mortality between selective vs. non-selective alpha blockers.     This study is a randomized controlled trial that will compare hemodynamic instability,     morbidity, mortality, cost, and quality of life between patients blocked with     phenoxybenzamine vs. doxazosin.   "
8344|NCT03176680|"     The goals of this study are to testify the effectiveness on enhancement recovery by new     anesthetic ERAS (Enhanced recovery after surgery) strategy.   "
8345|NCT03176667|"     This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal     nerve block plus PCA as post-operative pain control for patients having video-assisted     thorascopic surgeries.   "
8346|NCT03176654|"     This study evaluates the effect of high-velocity low-amplitude thrust (HVLAT) manipulation to     the cervical spine on neuropeptide expression as determined by the plasma concentration of     oxytocin, neurotensin, orexin A and cortisol; and Examine the effect of HVLAT manipulation on     pain perception in symptomatic females with non-specific mechanical cervical spine pain   "
8347|NCT03176641|"     This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by     comparing the imaging and clinical outcomes between patients receiving PRP with meniscus     repair surgery and those receiving meniscus repair surgery only.   "
8349|NCT03176615|"     The purpose of this study is to investigate harmful effects of intentional weight loss.     Intentional weight loss has been linked to increased risk of cardiovascular disease in     overweight individuals, but the link between intentional weight loss and thrombotic disease     is poorly understood. Postprandial coagulation activation, including thrombin generation, is     a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass     will be included in a randomized, cross-over clinical trial. All patients will consume a     high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven     days apart). This cross-over study will be carried out before weight loss, during     lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass.     Fasting and postprandial blood samples are collected on each study days, while one fecal     sample is collected for each study period. The study will contribute to our understanding of     mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in     relation to intentional weight loss programs must be modified.   "
8350|NCT03176602|"     There are two nutrition assessment tools that are commonly used in the ICU, namely the     Subjective Global Assessment (SGA) and Modified Nutrition Risk in Critically Ill Score     (mNUTRIC). It has been proposed that both assessments should be performed in the ICU but     their combined prognostic ability has not been adequately assessed.      This study aimed to: 1) determine the agreement between SGA and mNUTRIC scores, and 2)     quantify their utility in discriminating and quantifying hospital mortality risk both     independently and in combination.   "
8351|NCT03176589|"     PEP (positive expiratory pressure) is routinely given to patients after surgery in order to     improve lung function. There is, however, no evidence of effect on lung function,     postoperative pneumonia or any other outcome (Guimarães MMF, Tyson AF). The investigators aim     to test the immediate effects on oxygen saturation and carbon dioxide. 65 patients will be     investigated in RCT design with deep inspirations and expiration using PEP or only deep     inspiration with expiration a placebo tube without resistance air. At the end of the study we     will also measure the effect of 10x3 very deep inspirations and no expiratory no expiratory     resistance. Primary outcome: continuous oxygen saturation from pulse oximetry and     transcutaneous carbon dioxide.   "
8352|NCT03176576|"     The purpose of this study is to develop and test a model of patient navigation that     investigators hope will address the unique needs of adolescent and young adult (AYA) cancer     patients and their families by minimizing barriers in their care and potentially improving     the outcomes of their treatment while reducing distress and enhancing quality of life.     Investigators plan to achieve this by increasing access to, and use of, the resources     available at Moffitt Cancer Center for AYA patients and their families.   "
8353|NCT03176563|"     Observational follow-up study of patients included in the clinical trial REGATTA.   "
8410|NCT03175822|"     The purpose of the proposed study is to better understand what benefits visual art has on     reducing problematic symptoms in dementia patients, including those with Alzheimer's disease.   "
8361|NCT03176459|"     Primary objective: The primary objective of this study is to compare total opioid consumption     through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus     abdominis plane (TAP) after spinal anesthesia to active bupivacaine HCl TAP infiltration     after spinal anesthesia in subjects undergoing an elective cesarean section (C-section).      Secondary objective: The secondary objectives are to assess efficacy and safety parameters     and patient satisfaction.   "
8362|NCT03176446|"     Fear and dental anxiety are often associated with the use of needles and syringes for local     anesthesia, and painful perception during the administration of local anesthetics is often     the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in     childhood, through experience misconduct. The objective of this study is to evaluate the pain     and anxiety related to 4 different modalities of anesthesia in children. Will be selected     volunteers aged between 5 and 12 years who need restorative dental treatment in posterior     teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia:     conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and     computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological     and behavioral criteria. For the physiological evaluation will be measured the blood     pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each     anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and     modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain     will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong     Baker Faces. The results will be submitted to parametric and non-parametric statistical     analysis, according to the data obtained in the different evaluation criteria.   "
8363|NCT03176433|"     The aim of this study is to assess the safety and feasibility of a short period of cold     storage prior to normothermic machine perfusion in adult liver transplantation.   "
8376|NCT03176264|"     This is a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line     therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study     will assess primarily the safety and tolerability and then the efficacy of PDR001 in     combination with bevacizumab and mFOLFOX6. Particular attention will be paid to the level of     activity of study drug combinations in CMS4 patients (retrospective analysis).   "
8439|NCT03175432|"     The goal of this clinical research study is to learn if atezolizumab and bevacizumab can help     to control the disease in patients with cancer that has spread to the brain.      The safety of this drug combination will also be studied.   "
8364|NCT03176420|"     Ischemic stroke is the fourth leading cause of disability and mortality in the United States.     The overall risk of emboli detachment from a chronically occluded internal carotid artery     (COICA) is around 7% per year. Despite receiving the best available medical therapy, about 6%     to 24% of these patients will subsequently suffer transient or permanent ischemic     complications annually. This has been theoretically attributed to a cerebrovascular     hemodynamic impairment.      The management of chronic or subacute internal carotid artery (ICA) occlusions has been     challenging clinically. Carotid endarterectomy and superficial temporal artery to middle     cerebral artery bypass have been studied in high risk stroke patients with results showing no     benefits in symptomatic COICA patients. Consequently, some centers have employed angioplasty     and stenting for the management of these challenging lesions. The main concern with the     endovascular treatment of COICA patients is the significant risk of perioperative     complications such as distal embolization, vessel perforation, pseudoaneurysm formation,     vessel dissection, fistula formation, and hyperperfusion syndrome. In this report, we propose     for the first time a COICA classification, which could offer the interventionalist a guide of     the technical feasibility and safety of endovascular recanalization of symptomatic COICA. We     will assess the success of this classification in predicting endovascular recanalization of     symptomatic COICA in a single -institution pilot study.   "
8365|NCT03176407|"     The clinical trial entitled Detection of upper gastrointestinal (GI) bleeding with a novel     bleeding sensor capsule - a pilot study was carried out in a monocentric clinical trial with     30 patients. This trial aimed to determine if the capsule's sensor signals allow to deduct     the patient's bleeding status in a clinical setting.      The target of the explorative study was to show the feasibility and safety of the HemoPill     acute and its implementation procedure as well as, the definition of measurable parameters     and thresholds for blood detection. Within this clinical trial, initial clinical data on the     performance of the HemoPill acute capsule were collected.   "
8366|NCT03176394|"     This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days)     catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel     (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis     will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.   "
8367|NCT03176381|"     This is an observational, prospective (study following participants forward in time),     multi-center (study conducted in more than 1 center) study to identify the predictive factors     that will effectively predict the response to abiraterone treatment in metastatic     castration-resistant prostate cancer (mCRPC). The entire duration of study will be     approximately 3 year. Participants will primarily be evaluated for achieving biochemical or     radiological progression after receiving abiraterone treatment based on EAU 2017 practice     guideline criteria. For this, we put our attentions on the FKBP5 (FK506 Binding Protein 5,     Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by     NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are     selected from the data of gene-array for various subtypes of CRPC (unpublished data).     Response to abiraterone treatment will also be predicted using other androgen-regulated genes     like AKR1C3 and PCNA.   "
8368|NCT03176368|"     This study will seek to assess the experience of using of coconut oil as an approach to     managing radiation-induced xerostomia in patients previously treated for cancer in the head     and neck. There is a high prevalence of radiation-induced xerostomia in this patient     population, and the condition has significant negative impact on patients' quality of life.     There is currently no agreed-upon standard of care for the treatment of this condition.     Anecdotal evidence from patients and both physicians and allied healthcare providers suggests     improvement in this condition with the use of coconut oil, but this has not previously been     formally studied. We therefore propose a case series study to formally assess the     tolerability and efficacy of coconut oil as an approach to managing radiation-induced     xerostomia.   "
8370|NCT03176342|"     The study is about drug patch tests in patients who have history of severe cutaneous drug     reaction including Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),     Drug-induced eosinophilia and systemic symptoms (DRESS), AGEP (Acute generalized     exanthematous pustulosis) and generalized bullous fixed drug eruptions. This study also     investigate in Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation     test. We also trying to prove the correlation among result of drug patch tests, ELIspot and     LTT.   "
8371|NCT03176329|"     Nursing is essential in critically ill patients care but with high risk of hypoxia,     especially during mobilization. Full closed-loop control ventilation is well established for     her safety in unselected ventilated critical care patients with different lung conditions     compared to conventional ventilation.      The aim of this study is to assess the ability of a full closed-loop control ventilation     (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated     patients.   "
8372|NCT03176316|"     Postoperative ileus and opioid induced constipation are well-known post-operative     complications. Previously, research has shown that using peripherally acting opioid     antagonists can help alleviate the condition. There has not been a prospective study to     investigate whether use of peripherally acting opioid antagonists are effective in preventing     post-operative ileus in patients having spinal fusion surgeries.   "
8373|NCT03176303|"     This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on     lumbar fusion rate in high risk subjects who have had lumbar fusion surgery. All participants     will wear the bone growth stimulator for a minimum of 2 hours/day for 6 months.   "
8374|NCT03176290|"     The aim of this study is to compare prospectively the ability of MRE and Transient     Elastography in detection and staging of allograft fibrosis in comparison to Liver biopsy in     patients who underwent Living Donor Liver Transplantation for complications related to HCV.   "
8375|NCT03176277|"     This study will determine the safety and maximum tolerated dose of ONO-7475 in patients with     relapsed or refractory acute leukemia and evaluate the efficacy of ONO-7475 in patients with     newly diagnosed AML   "
24639|NCT02963168|"     This is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to     determine the MTD and optimal dosing regimen of Oradoxel. No control group has been included.   "
8377|NCT03176251|"     Simulation-based training curricula for gastrointestinal endoscopy have been developed and     have been shown to be effective. It is possible that these curricula may be further improved.     Gamification, the application of game-design principles to non-game contexts, has been shown     to improve learning and skill performance in medical education. In gastrointestinal     endoscopy, however, no dedicated curricula have been developed using gamification principles.     We aim to evaluate the impact of applying gamification to a curriculum using SBT in endoscopy     on clinical performance, compared to an identical curriculum without gamification. 36 novice     endoscopists from the general surgery and gastroenterology programs at the University of     Toronto will be recruited. Participants will be randomized into two groups: the Conventional     Training Curriculum (CTC) Group, in which participants will receive 6 hours of training on a     simulator augmented with expert feedback and interlaced with 4 hours of didactic training on     the theory of colonoscopy; and the Gamified Integrated Curriculum (GIC) Group, in which     participants will receive the same curriculum, using the following applications of gamified     learning: a leaderboard of participant performances; badges for achievement of training     landmarks; and rewards for top performance. Participants will be trained to perform     colonoscopies progressively moving from a low to high complexity simulators, starting with     the bench-top model (1 hour) and then moving to the EndoVR® virtual reality (VR)     gastroenterology simulator (5 hours). Performance will be assessed at three points: prior to     training (pre-test), immediately after training (acquisition post-test) and 4-6 weeks after     training (retention test). Assessment will take place on the simulator at all three time     points and during two live colonoscopies at the retention test. The primary outcome measure     will be the difference in clinical colonoscopy performance between the two training groups,     as assessed by the Joint Advisory Group for GI Endoscopy Direct Observation of Procedural     Skills (JAG/DOPS). We aim to have data collection finished by 2018. Our results have the     potential to improve existing curricula for training in colonoscopy. Moreover, the     development of a gamified curriculum in procedural skills may have applicability to other     specialities, such as general surgery and anesthesiology.   "
8378|NCT03176238|"     The present international, multi-center, open-label, single-arm study aims at collecting     clinical safety, tolerability and efficacy data with the use of everolimus combined with     exemestane in the Novartis Oncology Emerging Growth Market (EGM) countries for the treatment     of post-menopausal women with hormone receptor (HR) positive, human epidermal growth factor     receptor 2 (HER2) negative locally advanced or metastatic breast cancer after documented     recurrence or progression following a non-steroidal aromatase inhibitor (NSAI) therapy.   "
8379|NCT03176225|"     The purpose of this clinical trial is to collect safety and effectiveness data to support     cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the     China FDA regulations for this kind of device. The clinical trial will be performed solely     inside China under GCP regulation and all applicable China regulations on medical device     clinical trial.   "
8380|NCT03176212|"     This study was designed to determine if an ingredient in milk fat can prevent gut leakiness     induced by running at 80% maximum oxygen consumption (VO2max). In mouse studies, the milk fat     ingredient, and individual components thereof, have been shown to reduce gut leakiness     induced by intra peritoneal lipopolysaccharide (LPS) injections.      The investigators hypothesis is as follows: Compared to a sports drink with identical macro     nutrient composition, a sports drink with milk fat globule membrane (MFGM) will reduce the     change in gut leakiness induced by running at 90% VO2max for 30 minutes. The decrease in gut     permeability change will be associated with a decreased area under the curve of plasma     endotoxin for 5 hours following the exercise. In addition, decreased gut permeability will be     associated with lower area under the curve values for inflammatory cytokines.   "
8381|NCT03176199|"     This study is to evaluate the efficacy and safety of a titration method by selects 10 mg     control-released (CR) oxycodone tablet as background drug in combined with immediate-released     (IR) oxycodone, compared to conventional titration method with immediate-released (IR)     oxycodone in patients with moderate to severe cancer pain in Taiwan.   "
8382|NCT03176186|"     XePOHCAS: Prospective, randomized, multicenter interventional trial in adult subjects with     out-of-hospital cardiac arrest comparing treatment with standard-of-care post-cardiac arrest     intensive care (which is targeted temperature management [TTM]) to xenon by inhalation plus     standard-of-care post-cardiac arrest intensive care (including TTM).   "
8383|NCT03176173|"     This phase II trial studies how well radical-dose image guided radiation therapy works in     treating patients with non-small cell lung cancer that has spread to other places in the body     who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor     cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with     non-small cell lung cancer may help to improve response to immunotherapy anti-cancer     treatment.   "
8384|NCT03176160|"     The purpose of this study is to determine if Laser Interstitial Thermal Therapy (LITT) is     safe in newly diagnosed glioblastoma (GBM) patients unable to undergo broader surgical     resection. LITT, and specifically the NeuroBlate® System (NBS), represents a unique tool that     may permit the development of much needed novel treatment algorithms for those GBM patients     inappropriate for the conventional surgery followed by chemotherapy and radiation. The     primary objective is to assess the safety of combination LITT and short-course radiation     therapy (SCRT) for patients with newly diagnosed GBM not amenable to standard of care (SOC)     therapy.   "
8385|NCT03176147|"     Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach     10 to 20% of pregnant women in developed countries, with potentially serious consequences for     the child. Systematic iron supplementation remains controversial.      This study aims to identify in the first trimester of pregnancy clinical and biological     predictive factors for the occurrence of iron deficiency anemia in the third trimester of     pregnancy.   "
8386|NCT03176134|"     This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate     (MK-1986) compared with comparator antibacterial agent in participants 3 months to <12 years     of age with acute bacterial skin and skin structure infections.   "
8387|NCT03176121|"     This study is to evaluate the safety and tolerability of oxycodone control-released (CR)     and/or immediate-released (IR) use in patients with moderate to severe cancer pain in a     3-months period in Taiwan.   "
8396|NCT03176004|"     This is a multi-site study to examine error-related brain activity (i.e., the error-related     negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated     by two years. The study examines the degree to which error-related negativity can predict     anxiety prospectively over two years, and whether a computerized game that alters attention     to threat can alter error-related negativity and trajectories of anxiety.   "
8397|NCT03175991|"     Ovarian masses are common problems in clinical practice. Sonography is considered the     firstline imaging technique for discriminating between malignant and benign lesions, and it     has been shown to be useful for determining optimal treatment.   "
8471|NCT03175016|"     This is a multicentre, open labeled, single arm study to determine effectiveness and safety     of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable     liver metastases in patients with colorectal cancer after chemotherapy failure.   "
8388|NCT03176108|"     Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a     neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and     leads to functional impairment. ADHD is recognized as the most common psychiatry disorder in     children and it's considered as a public health problem.      ADHD is frequently associated with a new diagnostic entity  Disruptive Disorder with     Emotional dysregulation . This disorder is characterized by crisis of anger with verbal or     physical aggression, intensity disproportionate to the context and developmental age.      Few studies have examined the elements of emotional dysregulation in ADHD in children. Many     studies have shown the interest of CBT in multimodal management of ADHD symptoms and     associated disorders.      The main objective is to evaluate the effectiveness of a Cognitive-Behavioral Therapy     Parent/Child program versus a body mediation focused on emotional and behaviorial aspects in     ADD children aged 7-13 years with dimensional emotional dysregulation at 6 months after     intervention. Secondary objectives are to evaluate the impact of this program, at short-term     (at the end of CBT) and at 6 months after intervention, on socio-communicative capacities,     quality of life, children's functioning and parental stress.      It's a biomedical research, prospective, controlled, randomized, monocentric, two parallels,     with an evaluation of the criteria of blind judgment.   "
8389|NCT03176095|"     Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently     available treatment is a gluten-free diet. Recent studies have shown several probiotics to     carry properties that might positively influence the immunological activity in celiac     patients.      The aim of the present study is to investigate how daily consumption of probiotics would     affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease     autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac     disease.      Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective     celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were     randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration     of 6 months.      Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA     using radioligand binding assays.   "
8390|NCT03176082|"     Purpose: The investigators propose to test the effectiveness, feasibility, and     cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid     enrollees in Mecklenburg County.   "
8391|NCT03176069|"     Sexuality is considered one of the pillars of quality of life, an integral part of the     personality of each individual. Being a basic human being need, it cannot be separated from     other aspects of life. For several centuries and until recently, sexuality was considered the     lower instincts expression related only to the sexual act. Sex is associated with     reproduction of the sexual energy. On the other hand, the exercise of sexuality includes     various factors such as the building of the sensitivity between individuals like touch,     dance, fantasy, look, etc. For a long time feminine sexuality was predominantly focused on     procreation and has only recently been considered as an integral part of sexual and     reproductive rights of women. Vaginismus is a female sexual dysfunction that affects the     quality of sexual and psychosocial lives of women, influencing the quality of the couple's     relationship. The scientific literature emphasizes the importance of the examination,     diagnosis and physical therapy for this dysfunction, but until now there is no quantification     or evaluation of the pelvic floor muscles for this group of women, which justifies the     realization of this project.   "
8392|NCT03176056|"     This study determines whether an educational intervention with a 90 g/day LCD is safe,     effective and has good compliance for poorly controlled type 2 diabetes patients.   "
8489|NCT03174782|"     This study will be a double-blinded randomized controlled trial analyzing all patients who     will undergo major lower extremity amputations by the vascular surgery service at UCSF Fresno     between July 2017 and June 2018 to determine if regional nerve blocks (sciatic and femoral)     have any effect on postoperative pain control, narcotic requirements, and length of stay     compared with standard post-operative narcotic regimens.   "
8393|NCT03176043|"     The purpose of the study is to determine whether participants who are dictating their own     administration of IV fluid boluses in response to thirst, receive better protection from     hypovolaemia and volume overload than those who undergo routine fluid management.      Thirst is prominent in critically ill patients and is related to dehydration. In a recent     study of the symptoms experience in ITU patients at high risk of dying, the sensation of     thirst was reported in 70.8% of assessments made and was considered to be one of the most     intense stressors. Thirst and dehydration can be combated in an ITU setting by consuming oral     fluids and through administration of intravenous fluids. However, in older adults, frailty     and dysphagia reduces patients' capability to access fluid and results in thirst. In     addition, the administration of IV fluids is determined by the attending physician and is     often only re-evaluated on a daily or twice-daily basis.      The Quench machine has been designed to allow the patient to have more control over their     oral and IV fluid administration protocol. This may help reduce the sensation of thirst and     dehydration in patients. The machinery is an automated fluid delivery system that will     administer a given bolus of IV fluid in response to a trigger provided by the patient.      The purpose of the current study is to examine the physiological basis for the functional     benefit of this Quench system by investigating the effectiveness of the thirst response in     healthy humans as a guide for administration of intravenous fluid boluses.      To explore this, the investigators have designed a randomised, cross-over study. On one visit     IV fluid boluses will be administered as per the participants' request in response to thirst.     In the second arm of the study participants will be administered routine IV fluid maintenance     as per NICE guidelines. Body mass at the end of a 4 hour fluid administration intervention     will be our primary research outcome and will be compared between the two arms of the study.      From this comparison the investigators hope to show that a patient would be able to     accurately manage their level of hydration, both in terms of correcting dehydration and     avoiding fluid overload. It is thought that avoiding states of fluid imbalance can reduce     post surgical recovery times, reduce the incidence of post operative complications and avoid     critical complications of fluid imbalance, such as acute kidney injury.   "
8394|NCT03176030|"     Malnutrition in older inpatients is a significant problem espicially among those with     dementia. A number of methods have been used to tackle this issue and oral nutritional     supplements (ONS) were proven to be the most effective way. However, they are limited by     their poor tolerability due to lack of familiarity with these products. An alternative method     is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this     study to test the feasibility and acceptability of delivering fortified foods to older     patients whilst in hospital including those with dementia and frailty. This pilot study will     compare the daily protein and energy intake in older people before and after offering     fortified food. Furthermore, patients' likeability and staff acceptability of these fortified     foods will be assessed.   "
8395|NCT03176017|"     In this study, Investigators planned to compare Holmium Laser ejaculatory sparing and     non-ejaculatory sparing (conventional) TUIP using both subjective and objective assessment     tools for the degree of deobstruction.      Furthermore, the impact of both techniques on ejaculation and its secondary effect on orgasm     perception and different domains of sexual function will be thoroughly assessed.   "
8425|NCT03175614|"     This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years     selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the     effects of the addition of an ICT tool developed for the Smartphone application and a     Smartband in support of behavioral and educational recommendations to reduce weight.   "
8398|NCT03175978|"     The primary objective of this study is to determine the safety and tolerability of utilizing     the insulin-like growth factor-1-methotrexate conjugate, 765IGF-MTX for the treatment of     advanced, previously treated myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia     (CMML) and oligoblastic acute myelogenous leukemia (oligoblastic AML or O-AML), including     determining the maximum tolerated dose (MTD).   "
8399|NCT03175965|"     This study aims to examine whether P30 wave of somatosensory evoked potentials (SEP) is     related with outcome after cardiac arrest. The study design is a prospective,     multicenter-observational study. Patients survived after out-of-hospital cardiac arrest     undergoing hypothermic-targeted temperature management will participate in the study.     Relationship of P30 wave of SEP with the neurologic outcome on hospital discharge will be     evaluated.   "
8400|NCT03175952|"     The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients     with saphenous vein graft disease after coronary artery bypass graft, and planning for     receiving percutaneous coronary intervention after virtual histology intravascular ultrasound     will be enrolled between May 2017 and April 2019. These subjects will be followed up at 1, 6     and 12 months post-operation of PCI to assess the short-term and long-term effect.   "
8401|NCT03175939|"     This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of     distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but     without additional adjuvant chemotherapy.   "
8402|NCT03175926|"     Asthma is a major public health problem. The main treatments against asthma are delivered to     the lung through several dry-powder inhaler such as Turbuhaler ®, Diskus® and the new     Ellipta® device. In real life, patient's ability to handle a device is not routinely assessed     by their practitioner. We hypothesized that many asthmatics cannot properly prepare and prime     their device, which may alter the positive effects observed in clinical trials.   "
8403|NCT03175913|"     This was a single-blind, randomized controlled trial. Sixty-six patients who underwent caudal     epidural injection were randomized into the vapocoolant spray group or local infiltration     group. Before the insertion of a 20-gauge spinal needle, the subcutaneous tissue was     infiltrated with 3 ml of 2% lidocaine in the local infiltration group and vapocoolant spray     was applied just before the spinal needle insertion in the spray group. 100-mm visual analog     scale to evaluate the pain intensity of spinal needle insertion and a five-point Likert scale     for patient satisfaction and preference for repeated use were compared between the two     groups.   "
8404|NCT03175900|"     This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to     investigate the effects and neural mechanism of Naoandiwan on migraine patients by utilizing     fMRI and DTI method, as well as headache evaluation measures such as responder rate, headache     duration, PRO scale, etc.   "
8405|NCT03175887|"     This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation     at the forehead versus the left side of the head for treatment of Treatment Resistant     Depression.   "
8406|NCT03175874|"     Autophagy is recognized as a central mechanism for the regulation of aging. . Osteoporosis     (OA) and Alzheimer's disease (AD) are two forms of pathological aging, sometimes entangled,     including an over-risk of OP in AD and degradation of cognitive functions after OP fracture,     but the link between These two pathologies remain poorly understood.      The aim of this prospective pilot study is to evaluate the level of autophagy of osteocytes     (OST) in postmenopausal women with OP and to explore the hypothesis that the defect of     autophagy is one of the physiopathological links of the OP During the MA   "
8411|NCT03175809|"     The presence of trigger points in the pelvic floor musculature (PFM) is a frequent condition     in individuals with chronic pelvic pain (CPP) and is associated with higher levels of pain,     disability and functional decline. The purpose of this study is to test the effectiveness of     two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with     the addition of trigger point dry needling applied over(Lumbar square, psoas, external     obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with     CPP.   "
8413|NCT03175783|"     Early mobilization is an important element in Enhanced Recovery After Surgery (ERAS). It     reduces risk of conditions which are related to prolonged bed rest such as deep vein     thrombosis, lung atelectasis, pneumonia, and sacral sore. (Appelboom, Taylor et al. 2015) It     is also associated with shortened length of hospital stay, improved survival, and reduction     in health care cost.      However, early mobilization was not defined consistently in previous study. Some authors     recommend patients to get out of bed and ambulate on the day of operation while others define     as getting out of bed more than 2 hours on day of operation and up to 8 hours on second     post-operative day. (Wolk, Meissner et al. 2017) The inconsistency in definition is partly     due to the inability to quantify patients' mobility which is usually self-reported by     patients and is subjective.(Eva van der Meij 2017) This is especially true for elderly     patient in whom preoperative mobility varies significantly between individuals. For this     reason, the approach of early mobilization in elderly should be goal directed and     individualized according to their preoperative mobility and functional status.      The aim of current study is to monitor and motivate elderly patients undergoing abdominal     surgery to increase postoperative mobilization by using Fitbit Zip activity tracker.   "
8414|NCT03175770|"     In the last years radiofrequency resection has become a frequent method in surgical     subspecialties. Although many departments are using this method for the resection of Tumor in     the oropharynx, there is no study so far which describes feasibility and safety.      Goal of this study is to show feasibility and safety of Radiofrequency Resection in     Oropharyngeal Tumor Surgery.   "
8415|NCT03175757|"     The purpose of this study is to assess the effects of a turmeric and black cumin seed     formulation on cholesterol levels.   "
8416|NCT03175731|"     This study is aimed at investigating the effect of PPI on esophageal variceal bleeding in     cirrhotic patients. Half of participants will receive PPI, while the other half will receive     a placebo.   "
8417|NCT03175718|"     Project Summary - Aggressive soft tissue cancers are commonly treated with radiation followed     by surgery. These wounds have a very high rate of wound complications and infection (30%),     resulting in more surgeries, longer hospital stays and complex nursing care. Previous     research shows that negative pressure (vacuum) dressings applied to the incision at the end     of surgery can reduce these complications. The Investigator and his team across Canada will     perform a clinical trial comparing standard dressings to these vacuum dressings. The results     of this study have the potential to immediately improve the quality of life of soft tissue     cancer patients. It can also decrease the amount of time required in hospital and reduce the     cost to the Canadian healthcare system.   "
8418|NCT03175705|"     This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC     stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or     the patients cannot receive standard treatment under current conditions. This research study     uses specific HCC antigens CD8+ T cells, a new experimental treatment.      The purpose of this study is to evaluate the safety and tolerance as well as the potential     clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte     antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal     Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients     suffering from relapsed/advanced hepatocellular carcinoma (HCC).   "
8419|NCT03175692|"     Under the joint efforts of genetic and intensive expert, to establish the high-throughput     whole exon sequencing(WES) and analysis all the possible pathogenic genes. To provide patient     with the appropriate treatment for genetic disease. Besides, it can identify the genetic     factor of idiosyncrasy or susceptibility to explain the medical difficulties and give     patients personalized advice.   "
8420|NCT03175679|"     This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC     stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or     the patients cannot receive standard treatment under current conditions. This research study     uses special immune system cells called iNKT cells, a new experimental treatment.      The purpose of this study is to find the biggest dose of iNKT cells that is safe and     tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to     learn the side effects are and to see if the iNKT cells will help people with     relapsed/advanced hepatocellular carcinoma (HCC).   "
8421|NCT03175666|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with metastatic or unresectable TNBC who have progressed on or after     anthracycline-based chemotherapy or who have refused anthracycline-based chemotherapy.   "
8422|NCT03175653|"     The purpose of this randomized trial is to examine whether the number of opioid pills     prescribed for pain control after Cesarean section has an effect on patient reported pain     levels and satisfaction with pain control during recovery. Both groups receive what is     considered an adequate number of pills for pain control after an uncomplicated Cesarean     delivery. Secondarily, the investigators wish to gather reliable information about the     duration of use of opioids for pain control after uncomplicated Cesarean section, and what     happens to unused medication.      After an uncomplicated Cesarean section, patients will be approached and asked to participate     in the study. If the patient agrees, she will be randomly assigned to one of the two study     groups and receive a prescription for opioid medication at the time of hospital discharge. At     her standard care follow-up visit 10-14 days later, the participant will complete a survey     asking questions about her pain levels during recovery, her use of study-related and     non-study-related pain medication, and satisfaction with pain control. At that point the     patient's participation in the study will end.   "
8490|NCT03174769|"     This evaluates the affect of protein quantity on indices of sleep. Half the participants will     be prescribed protein in the amount consistent with the USDA healthy style eating pattern,     while the other half will be prescribed a diet containing 12.5 oz eq of protein.   "
8423|NCT03175640|"     The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids     among persons living with HIV, along with their common use of benzodiazepines, has resulted     in high rates of opioid overdose among this population. This study will test the     implementation of evidence-based training, mentoring, technical support, and academic     detailing to encourage HIV physicians to adopt evidence-based interventions to reduce     overdose risk and treat opioid addiction.   "
8424|NCT03175627|"     The purpose of this study is to determine whether a new tooth-colored composite material is     effective for load-bearing dental fillings.   "
11079|NCT03140878|"     The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over,     proof-of principle study in healthy volunteers. The study will determine the probiotic effect     of LGG on intestinal tissue and intestinal cells   "
8426|NCT03175601|"     The general objective of this study is to identify biomarkers of sleep quality, sarcopenia,     insulin resistance, oxidative stress and inflammation associated with prefrailty in     middle-aged and elderly obese subjects through the integrated study of sleep patterns,     functional cardiovascular testing, olfactory function and circulating molecules.      Results from the SleSOB study will contribute to identify molecular and functional     determinants of prefrailty, to allow early targeted interventions and will have important     implications for empowerment of elderly citizens to self-management of preventive measures     and healthy lifestyle.   "
8427|NCT03175588|"     The aim of this study is to assess the effectiveness of interactive video-games on mobility     and wellbeing and to compare them with activity-based approaches in geriatric population.      100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the     criteria will be included in the study. Persons will be placed in the study groups in     consideration of their interests. One group will be included in Nintendo Wii program with     balance board, which is the most frequently preferred game consoles in rehabilitation, and     video-games will run for 30 minutes two days a week for 8 weeks. The other group will     participate a program consisting of various physical activities for the same duration; The     results of both groups will be compared with a control group.   "
8428|NCT03175575|"     The pilot study aims to investigate the place of fresh garden produce in the food supply and     food practices of women in community gardens of deprived neighborhoods of Marseille, reputed     to be among the poorest in the European Union. We hypothesized that access to a community     garden in these neighborhoods could help instigate the adoption of healthier food patterns by     gardeners and their households, and in particular, increase their consumption of fruits and     vegetables.   "
8429|NCT03175562|"     The objective of this clinical study is to assess the irritation and sensitisation potential     of a cosmetic test product after repeated semi-occlusive patch applications to healthy human     participants by following a conventional HRIPT methodology under supervision of a     dermatologist.   "
8430|NCT03175549|"     The primary hypotheses under test are that alcohol dependent subjects treated with apremilast     will report decreased craving for alcohol following alcohol exposure in the laboratory and     report significantly less drinking under naturalistic conditions, than those treated with     placebo.   "
8431|NCT03175536|"     Asthma is one of the most common chronic diseases in the U.S. Despite guidelines, adherence     to recommended controller medications is low. Cost is an important barrier to adherence.     Employers are increasingly adopting high-deductible health plans (HDHPs) which require     deductibles of > $1,000 per individual/$2,000 per family each year. In HDHPs with Health     Savings Accounts (HSAs), most medications and non-preventive care must be paid out-of-pocket     (OOP) until the deductible is reached. The lower premiums of HSA-HDHPs are appealing, but the     high level of OOP costs can lead patients to forgo needed care. HSA-HDHPs can exempt     preventive care from the deductible, and employers can add Preventive Drug Lists (PDLs) which     exempt certain chronic medications from the deductible (including asthma medications), making     them free. PDLs have the potential to improve controller medication use, which could prevent     negative health outcomes and reduce cost-related trade-offs for families.      The goal of this research is to evaluate the impact of these two developments in the health     insurance market -- HSA-HDHPs and PDLs -- on medication use and clinical outcomes for adults     and children with asthma. To do this, tteh investigators will first conduct in-depth     interviews with patients with asthma and parents of children with asthma who have HDHPs and     traditional plans. Interviews will collect patient-reported data on how patients and their     families navigate their insurance plan and make health care decisions when faced with OOP     costs. Findings from the interviews will inform analyses of data from a large national health     plan from 2004-2017. Investigators will select adults and children with asthma whose employer     switched them from traditional plans to HSA-HDHPs with or without a PDL. Analyses will     examine changes in asthma medication use, emergency department (ED) visits, hospitalizations,     and OOP costs before and after changing plans compared to similar patients who did not switch     to a HSA-HDHP. The study aims to: 1) understand health care decision making and experiences     of families with asthma with HDHPs; 2) examine the impact of HSA-HDHPs with and without PDLs     on use of asthma medications and asthma-related ED visits and hospitalizations; 3) examine     the extent to which the response to HSA-HDHPs and PDLs is affected by the presence of other     family members with asthma or other chronic conditions; 4) examine the impact of HSA-HDHPs     with and without PDLs on OOP costs for families.   "
8432|NCT03175523|"     The objective of this trial is to compare clinical outcomes between imaging-guided and     QCA-guided strategy in patients with native coronary artery disease undergoing BRS     implantation.   "
8433|NCT03175510|"     This study, we performed the Turkish version validity and reliability of the Back Performace     Scale.   "
8434|NCT03175497|"     The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability     and pharmacokinetic profile of telatinib in China patients with advanced solid tumor   "
8435|NCT03175484|"     High-fidelity simulation (HFS) is a learning method extensively used for training of surgical     specialty (including anesthesia) and nurses. It has a beneficial effect on knowledge of     algorithms, team working, early warning scores, and communication. Various skills can be     learned using a standardized simulation programs.      The complexity of instructional design may produce cognitive overload, high stress level and     anxiety. This may increase fatigue, facilitate errors, and is associated with inferior task     performance which may impede memorization of learned skills resulting in inefficient     learning/simulation failure. Subjectively reported scales can accurately identify the level     of perceived workload and mental demand in individuals during simulation tasks. One example     is the National Aeronautics and Space Administration (NASA)-TLX - the most accepted     subjective measure of human workload in various industries including medicine.      Surgical specialty (including anesthesia) and nurses training curriculum in Lyon, France,     includes several HFS scenarios with a large panel of critical events. The investigators aim     to evaluate the effect of burden of workload and stress perceived by surgical specialty     (including anesthesia) residents and nurses during HFS on the learning performance, and to     grade different learning scenarios by their difficulty.   "
11630|NCT03133676|"     This study will evaluate the safety and tolerability of KA34 when administered via     intra-articular injection to subjects with osteoarthritis of the knee.   "
8436|NCT03175471|"     Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and     Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among     adolescents. In all these conditions, autoimmune lymphocyte responses are thought to     orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in     PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR     cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to     assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis.     In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will     be correlated with both liver histology and circulating biomarkers of these disease     processes.   "
8481|NCT03174886|"     This study is a pilot trial evaluating the safety and immunogenicity of AADvac1 in patients     with the non-fluent variant of Primary Progressive Aphasia.      50% of participants will receive the 40 µg dosage of AADvac1 and 50% of participants will     receive the 160 µg dosage of AADvac1. No placebo is used.   "
8440|NCT03175419|"     Setting up a Prospective Belgian National Registry of patients undergoing minimally invasive     liver resections will allow the constitution of a national network able to get updated     information on indication and results. Data will be of great importance for additional     scientific projects aimed to clarify the role of minimally invasive approach in surgical     liver pathology, especially malignancies.   "
8441|NCT03175406|"     Pre induction assessment using bishop scoring system and Manipal cervical scoring system     performed on 105 pregnant females   "
8442|NCT03175393|"     Coronary artery disease (CAD) is usually used to refer to the pathological problem affecting     the coronary arteries (usually atherosclerosis) that leads to Coronary Heart disease (CHD)     which includes the diagnoses of angina pectoris, MI and silent myocardial ischemia.      Despite the mortality for this condition has gradually declined over the last decades in     western countries, it still causes about one-third of all deaths in people older than 35     years.      Dyslipidemia is very important risk factors of atherosclerosis that is one of the causes     leading to cardiovascular disease Despite management of dyslipidemia by controling fasting     total plasma cholesterol and LDL cholesterol as these are the best biomarkers for prediction     of cardiovascular diseases (CVD) risk.      LDL elevation is absent in many patients with atherosclerosis and about 1/3 of cardiac events     remains to be unpredicted using this method. Even more, in fasting normolipidemic subjects,     increased CVD risk is associated with an exaggerated postprandial lipemic response.      Postprandial dyslipidemia is defined as a rise in triglyceride-rich lipoproteins (TRLs),     including chylomicron remnants (CMRs) and remnant lipoproteins (RLPs), after eating, has     drawn an increasing interest recently because of its association with cardiovascular events.     Chylomicron remnants (CMRs) have been shown to penetrate the artery wall and to be retained     within the intima.      Endothelial dysfunction is an initial process of atherogenesis and it contributes to the     pathogenesis of CHD. Postprandial hyperlipidemia (postprandial hypertriglyceridemia) is     involved in the production of proinflammatory cytokines, recruitment of neutrophils, and     generation of oxidative stress, resulting in endothelial dysfunction   "
8443|NCT03175380|"     This protocol will use leukapheresis to collect lymphocytes to study immune responses     following vaccination with BCG in BCG-naïve participants. These studies will include, but not     necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses,     anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses     will provide a detailed framework characterizing the immune responses that are induced and     responses that are not induced in humans by BCG, a partially protective TB vaccine. This     framework will allow new hypotheses to be formulated and tested regarding what new and more     effective TB vaccines should target for optimal protective immunity.   "
8444|NCT03175367|"     The primary objective of the study is to evaluate the reduction of low-density lipoprotein     cholesterol (LDL-C) by evinacumab in comparison to placebo after 16 weeks in patients with     primary hypercholesterolemia (heterozygous familial hypercholesterolemia [HeFH], or non-HeFH     with a history of clinical atherosclerotic cardiovascular disease [clinical ASCVD]) with     LDL-C ≥ 100 mg/dL (2.59 mmol/L) despite maximally tolerated statin and proprotein convertase     subtilisin/kexin type 9 (PCSK9) inhibitor therapy.   "
8445|NCT03175354|"     This is a randomized, double-blind, vehicle-controlled study to evaluate the safety and     efficacy of ALX-101 Gel 1.5% and 5% and a matching ALX-101 Gel Vehicle when applied topically     twice daily for 42 days to adult and adolescent subjects with moderate atopic dermatitis.   "
8446|NCT03175341|"     Forty years ago clinical studies conducted by Ewan Cameron and Linus Pauling suggested that     intravenous (IV) and oral ascorbic acid (AA) may diminish symptoms and could improve survival     in terminal cancer patients. Previous phase I and II clinical trials have found that high     dose (1.5g/kg ) iv AA is well tolerated in cancer patients. This is a phase I/II, randomized     study of parenteral administration of Ascorbic Acid (AA) as a supplement to the conventional     neo-adjuvant chemotherapy in women with breast cancer.   "
8447|NCT03175328|"     Sepsis continues to be a major global cause of both mortality and morbidity. Furthermore, the     development of acute kidney injury (AKI) in sepsis increases the risk of unfavorable     outcomes. Besides source control, fluid resuscitation and the use of antibiotics, application     of extracorporeal renal replacement therapies (RRT) is the predominant treatment for     sepsis-associated AKI (SAKI). However, the timing of initiation of RRT remains controversial.     It is reported that a correlation was observed between the concentrations of circulating     inflammatory cytokines and mortality in patients with septic shock. Therefore, it is     hypothesis that adequate removal of inflammatory mediators from the circulation may provide a     potential therapy for this devastating condition. Indeed, data from meta-analyses,     observational studies and randomized controlled trial (RCT) suggests that initiating RRT in     critical ill patients (including patients with sepsis and non-sepsis) at early stage may be     beneficial. But in some studies, initiating RRT at early stage do not shown to improve     survival compared with initiating RRT at late stage. At present, large-scale prospective RCT     about the timing for initiating RRT in SAKI was still lack.The decision when to start RRT is     not merely academic but may impact on outcomes. Therefore, in our study, 600 patients with     SAKI at KDIGO 2 from multicenter in China will be recruited. And then the patients will be     divided into early group and delayed group randomly. In the early group, continuous RRT     (CRRT) was started immediately after randomization. In the delay group, CRRT was initiated if     at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, metabolic     acidosis, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter, or     oliguria for more than 72 hours after randomization. Overall survival at day 90 will be     observed in order to understand whether different CRRT strategy would affect the outcomes of     SAKI. This clinical study will be a large-scale, multi center, prospective, randomized trial     about SAKI. It will help clinician choose appropriate timing to initiate CRRT and improve     outcomes of SAKI.   "
8448|NCT03175315|"     This study is a randomized, controlled, prospective trial with a 6-month follow- up. A newly     developed psychoeducational treatment and education programme for diabetic patients on an     insulin therapy who use flash glucose monitoring (FGM) will be tested compared to a waiting     group. Primary outcome variable is the difference in glycemic control between baseline and     the 6-month follow-up. Secondary outcome variables are: time-in-range, frequency and duration     of hypo- and hyperglycemic episodes, diabetes-related distress, depressive symptoms,     health-related quality of life, diabetes self-efficacy, self-care behavior, and hypoglycemia     awareness.   "
8449|NCT03175302|"     This study leverages a modernized digital version of a well-known cognitive screening tool to     examine pre and post operative cognitive function after surgery in adults age 65 years or     more. Machine learning algorithms will be applied to the hospital wide standard of care     cognitive metric to identify risk for post-operative cognitive complications.   "
11978|NCT03129113|"     This is a multicentre, phase IV, randomised, open-label, trial exploring adjunctive maraviroc     and/or metformin for liver steatosis over 48 weeks.      Sponsored by University College London Coordinated by MRC Clinical Trials Unit at UCL   "
8450|NCT03175289|"     This randomized clinical trial studies how well expiratory muscle strength training works in     improving bulbar function and quality of life in patients with head and neck cancer.     Expiratory muscle strength training may help to strengthen the muscles involved in breathing     and swallowing and may allow improved breathing, airway safety, swallow function, and quality     of life in patients with head and neck cancer.   "
8451|NCT03175276|"     To investigate the usefulness of the Informant Questionaire on Cognitive Decline in the     Elderly (IQCODE) to predict delirium in elderly patients admitted to Emergency Department     (ED) with geriatric assessment and transferred to Geriatric ward.   "
8452|NCT03175263|"     This study was an observational, open-label, cohort-study conducted in accordance with the     principles of the Helsinki Declaration. We prospectively and systematically recorded data     from the patients and analyzed them retrospectively. During a first phase, called adaptation     period, the injector (DR) used a follow-the-pain approach in order to determine the optimal     injection scheme for each individual. The possible injection sites were the corrugator,     temporalis, and trapezius muscles. Patients were systematically asked about the usual     topography and time course of migraine attacks, and the existence of pain or stiffness of the     cervical muscles. If the pain was predominantly located in the frontotemporal area, the     corrugator and temporalis muscles were injected bilaterally. When the patients had     predominant pain in the back of the head, or when their headache pain frequently started     and/or ended in the trapezius muscles, both trapezius muscles were injected. These muscle     groups were injected together if pain was both frontotemporal and cervico-occipital. When     this first set of injections was efficacious, patients were re-injected in the same manner at     the time when the frequency of headache days definitely increased. In the absence of     efficacy, the paradigm was modified using the same follow-the-pain approach. Once the best     procedure was determined for each patient, it was reproduced at each subsequent injection     session. This adaptation phase could necessitate up to three sessions. The observation period     started 8 weeks before the first efficacious injection and ended 2 months after the second     consecutive efficacious injection, or in case of inefficacy. Throughout the adaptation and     the observation phases, patients kept a headache diary where they were asked to note the days     with headache and the use of rescue medication.   "
8453|NCT03175250|"     A randomized trial was conducted at drug diversion educational programs with a sample of 343     adult drug offenders who volunteered for the study. The trial tested three different     interventions on HIV testing and condom use, with a 3 month follow-up. The study translated     consistent basic research showing strong effects of memory practice on memory for new     material. One of the conditions involved extensive memory practice of action plans involving     HIV testing and condom use. Other conditions varied two active control interventions. Results     showed that the memory practice condition led to a substantially larger odds of HIV testing     than did the two control conditions. Condom use was also significantly more frequent in the     memory practice condition than in one of the control conditions but was not significantly     different from the second control condition.   "
8454|NCT03175237|"     To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different     levels of post-stroke motor impairment with two different therapy protocols. This is a     randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke.     Participants were randomized into two intervention groups: MT group with motor patterns of     movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor     impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation     Inventory) and functionality (Functional Independence Measure - FIM) were performed before     and after treatment, and 3 months after the end of sessions (follow-up). In each intervention     group,there were patients classified with mild, moderate or severe motor impairment,     according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes     each session.   "
8455|NCT03175224|"     The purpose of this study is to determine the safety, tolerability, and recommended dose of     CBT-101 in individuals with advanced solid tumors and c-MET dysregulation.   "
8456|NCT03175211|"     The primary objective of this trial is to investigate the safety and tolerability of BI     456906 in healthy subjects following single rising doses.      The secondary objective is the exploration of the pharmacokinetics including dose     proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing   "
8457|NCT03175198|"     The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in     real-world setting after the availability of idarucizumab   "
8458|NCT03175185|"     The aim of this study is to carry out a psychological evaluation for the parents of children     diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children     without ADHD as control to detect any psychological problems in those of children with ADHD .     These problems may be a precipitating factor to cause ADHD in their child or have a genetic     predisposition to be passed to their children. On the other hand these psychological problems     may be caused by the difficulties they encounter in raising their ADHD child. The exact     relation needs more researches and to be more investigated.   "
8459|NCT03175172|"     The purpose of this study is to evaluate whether CRS-207 with pembrolizumab is safe and     effective in adults with MPM who have failed prior anti-cancer therapy.   "
8460|NCT03175159|"     This study seeks primarily to test, in a three-arm randomized controlled trial (RCT), the     efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with     HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with     stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a     diagnosis of stimulant use disorder will be randomized 2:2:1 to three arms: (1) the Project     IMPACT intervention, BA-RR counseling, which lasts ten sessions; (2) the time- and     intensity-matched control condition, including ten sessions of relaxation therapy with     educational support; and (3) the standard of care (SOC) comparison condition, including two     equivalent sexual risk-reduction counseling sessions. Participants will be followed for one     year post-randomization, with assessments at months four, eight, and 12.   "
8461|NCT03175146|"     The proposed study will evaluate if curative intent SBRT can provide high response rates     and clinically meaningful cancer control with acceptable toxicity specifically in patient     with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer     responding to systemic therapy   "
8462|NCT03175133|"     This study will pilot a strengthening intervention targeted to muscles found to be important     to gait in people with multiple sclerosis (MS). Previous studies that have tried to     strengthen leg and trunk muscles in people with MS have failed to improve walking ability     consistently. We think that is because strengthening exercises were not targeted to the     correct muscle groups. For this study the investigators propose targeting muscle groups that     they have found to be strong contributors to walking in a prior study. This is the first     study to target these muscles, so the investigators propose doing a small trial to first     evaluate the feasibility of the strength program and the outcomes. The investigators will     measure strength and walking measures twice before and once after an 8-week strengthening     intervention in a single group of 10 people with MS who are able to walk independently. The     results of this study will help inform future, larger trials that could change the way     strength training is conducted in people with MS.   "
8463|NCT03175120|"     This trial is conducted in Asia. The aim of this trial is to confirm the superiority of     insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese     subjects with type 2 diabetes mellitus after 26 weeks of treatment   "
8464|NCT03175107|"     The purpose of the PD_manager project is to explore and develop innovative ecosystem     management for people with Parkinson's disease. The research part contains expert analysis of     diagnostic tests and decomposition of activity, accompanied by modern IT. The results of the     analysis will be compared with the results of clinical trials that fall under the routine     clinical pathways in monitoring a patient with Parkinson's disease. The primary motor     symptoms, such as tremor, bradykinesia and impaired balance, and other symptoms, such as     sleep disturbances, speech and cognitive perception, will be assessed by unobtrusive sensors     (shoe insoles, bracelets) and sensors embedded in a mobile phone. The collected data will be     analyzed using data mining methods and a platform for clinical decision support will be     developed. This way, dependency of the patients on other persons will be reduced and the     patients' quality of life improved. The patients will be motivated to follow the prescribed     diet and take regular medication; the patients' activities will be monitored by occupational     therapists and physiotherapists. A technical system will be designed as a computing platform     in the open architecture cloud (FI-WARE), which will allow the use of commercially available     sensors.   "
8465|NCT03175094|"     After enrollment, participants will be randomized to either receive the intervention     (treatment) from trained health educators or undergo observation as usual (control group).     Randomization will be stratified by HIV serostatus. A control group is appropriate because     participants will still receive services offered through probation and will be offered the     intervention after completion of the trial. Subjects will be paid, not for participating in     the intervention, but for providing research assessments. The newly adapted intervention will     be delivered over no more than a 3-month period (it will be shorter if the adaptation process     is supportive). Baseline assessments will assess the pre-intervention period. The 3-month     assessment will be the end-of-intervention effects and the post-intervention assessments will     be at 6, 9 and 12 months. HIV prevention knowledge will be assessed based on quizzes used     previously for HHRP+; though final quiz content will depend on final selected materials for     the intervention. Subjects will be followed for 12 months with assessments by trained     research assistants.   "
8466|NCT03175081|"     Obesity is a metabolic disorder that has gradually become a prevalent public health problem     and is becoming one of the leading causes of death and disability worldwide. The most     efficacious therapy for morbid obesity today is bariatric surgery. Bariatric surgery     increases life expectancy by correcting the comorbidities associated with obesity, improves     the quality of life, and is associated with reduced morbidity and mortality. There is an     increase application of laparoscopic procedures as it is considered to cause less pain than     traditional open surgery, smaller incision, reduced blood loss and shorter postoperative     stay, which cuts down on hospital cost. However, postoperative pain still exists causing     unpleasant experience for the patient and at times causes a delayed discharge. Pain after     bariatric surgery is a result of many mechanisms such as tissue injury, abdominal distention,     local trauma of the stomach, chemical irritation of the peritoneum, and the pneumoperitoneum     and this pain potentially can prolong hospital stay and lead to increased morbidity, and     bariatric surgeons are striving to minimize the morbidity of current procedures to improve     patient outcomes and this gave rise to the use of intraperitoneal local anesthetics (LA). It     was found that the use of intraperitoneal LA in laparoscopic cholecystectomy is safe, and it     results in a statistically significant reduction in early postoperative abdominal pain. Many     studies were done to evaluate the efficacy of intraperitoneal LA in laparoscopic     cholecystectomy, gynecologic procedures and appendectomy but to date there are limited     studies done to evaluate the role of intraperitoneal LA in bariatric surgery. The aim of this     study is to evaluate the effectiveness of intraperitoneal instillation of local ropivacaine     on postoperative abdominal pain after bariatric surgery. We hypothesized that the     administration of intraperitoneal instillation of local ropivacaine would help reduce     postoperative pain.   "
8467|NCT03175068|"     Many patients with Major Depressive Disorder (MDD) and generalized Social Anxiety Disorder     (gSAD) are treated with cognitive behavioral therapy (CBT) but few have meaningful     improvement. MDD and gSAD are diseases of brain dysfunction that manifest as impaired emotion     regulation; CBT teaches emotion regulation strategies but how it works in the brain remains     largely unknown. Individual differences in brain function related to emotion regulation may     make some patients better suited for CBT and CBT may remedy the brain dysfunction that     underlies these disorders. This project will compare CBT with a placebo psychotherapy (i.e.,     supportive therapy) in MDD and gSAD to test, validate, and refine brain-based markers and     examine mechanisms of change to examine how CBT works and for whom.   "
8468|NCT03175055|"     This study will evaluate the Phoenix device for safety and effectiveness at allowing persons     with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of     conditions.   "
8469|NCT03175042|"     Pregnant patients in the UT Medical Branch outpatient obstetric clinic are screened for     anemia via blood draw at first prenatal visit. Those who meet Center for Disease Control     (CDC) criteria for anemia during pregnancy (hemoglobin less than 11g/dL in first and third     trimesters and hemoglobin less than 10.5g/dL during the second trimester), will be approached     for participation in this study. It is the protocol of the UT Medical Branch outpatient     obstetric clinic to repeat a blood draw every 4 weeks in patients with anemia. At the time of     their blood draw, patients who participate in our study will have the Masimo Spot     Non-invasive Hemoglobin monitor placed on our finger. The primary aim of the study is to see     how accurate the non-invasive monitor is compared with blood draw. With the potential benefit     being earlier diagnosis of anemia and easier method to ensure improvement in the hemoglobin.   "
8470|NCT03175029|"     The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor     underactivity patients with overactive bladder.   "
24640|NCT02963155|"     Prospective research of Natural Killer cells as predictive biomarkers to stratify patients     likely to have longer response time to castration.   "
8472|NCT03175003|"     The current study conducted will lend toward the optimization of the development of a food     product that will promote a shift towards improved metabolic health. Specifically, this trial     will determine the optimal level of protein needed to elicit positive changes in markers of     inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular     function, and the relationship of these changes to the metabolome in overweight and obese     school aged children (9 - 13 years of age).   "
8473|NCT03174990|"     This study evaluates the effects of Aspirin and thienopyridine resistance in relation to     clinical cardiovascular outcomes as the genetic predictors of, and outcomes associated with     aspirin and thienopyridine resistance in patients with peripheral arterial disease (PAD)     currently remain unknown.   "
8474|NCT03174977|"     This is a single-center drug distribution and pharmacokinetic study of a single microdose of     18F-raltegravir given to 10 HIV-infected subjects who are either taking or not taking a     raltegravir-containing ART regimen. After administration of IV 18F-raltegravir, subjects will     undergo PET/MRI in order to determine the distribution of radiolabeled drug through the     lymphoreticular system and other tissues throughout the entire body.   "
8475|NCT03174964|"     Infertility and miscarriage ordinary events in reproductive failure in humans, as are     affected one couple in every six couples of reproductive age and abortion is including in     approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted     Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains     below 30% and Recurrent Implantation Failure in one of the most important limiting factor is     the assisted reproductive techniques. According to studies conducted in recent years one of     the most important mechanisms of implantation failure is maternal immune system because the     fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that     ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly     associated with implantation failure. It also increases the number of natural killer (NK)     cells and Th17 cells and their cytokines in peripheral blood of mother and is also associated     with an increased risk of infertility. Several studies have also shown that the fertile     persons in compare to infertile have increased amount of Treg cells and inhibitory cytokines     associated with it. The studies have shown that if patients are properly selected RIF and     placed under appropriate immunotherapy approaches it will be seen a significant increase in     fertility. In previous years, followed by the production of intravenous immunoglobulin (IVIg)     and determine its effect on immune suppression, IVIg uses for the treatment of various     diseases such as thrombocytopenic purpura, Guillain-Barre syndrome, Kawasaki disease and     Myasthenia gravis. It is also valuable drug for the treatment of patients with infertility     problems have also been used but still remains how well the drug and its mechanism of action     are unknown. Probably one of the mechanisms of IVIg is its effect in suppressing the activity     of NK cells. Likely IVIg cause to increase Cluster of Differentiation 94 (CD94) molecule as     an inhibitor molecule on the NK cells and reduced the cytotoxic activity of NK cells. So     because of reduce the cytotoxic activity of NK cells by IVIg in patients with RIF injection     increases the likelihood of successful implantation. Previous studies have shown that the     incidence of genetic abnormalities in children who have received immunosuppressive drugs such     as IVIg like normal people and normal society. In this study we used IVIg before IVF to     suppress the immune system in patients with immunological causes of RIF and the results will     be compared with a control group that did not receive any type of drug.   "
8476|NCT03174951|"     Infertility and miscarriage ordinary events in reproductive failure in humans, as are     affected one couple in every six couples of reproductive age and abortion is including in     approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted     Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains     below 30% and Recurrent Implantation Failure in one of the most important limiting factor is     the assisted reproductive techniques. Determine the causes of Recurrent Pregnancy Loss (RPL)     can raise the success rate of assisted reproductive techniques and hope infertile couples and     reduce psychological pressure on them and also reduce costs is very important. According to     studies conducted in recent years one of the most important mechanisms of recurrent     miscarriage is maternal immune system because the fetus as an allograft toxic (Semi     allograft) to the mother. Studies have demonstrated that ratio of Th1 to Th2 cells increase     in maternal peripheral blood cells can be directly associated with recurrent pregnancy loss.     It also increases the number of Natural killer (NK) cells and Th17 cells and their cytokines     in peripheral blood of mother and is also associated with an increased risk of infertility.     Several studies have also shown that the fertile persons in compare to infertile have     increased amount of Treg cells and inhibitory cytokines associated with it. The studies have     shown that if patients are properly selected RPL and placed under appropriate immunotherapy     approaches it will be seen a significant increase in fertility. In previous years, followed     by the production of intravenous immunoglobulin (IVIg) and determine its effect on immune     suppression, IVIg uses for the treatment of various diseases such as thrombocytopenic     purpura, Guillain-Barre syndrome, Kawasaki disease and Myasthenia gravis. It is also valuable     drug for the treatment of patients with infertility problems have also been used but still     remains how well the drug and its mechanism of action are unknown. Probably one of the     mechanisms of IVIg is its effect in suppressing the activity of NK cells. Likely IVIg cause     to increase Cluster of Differentiation 94 (CD94) molecule as an inhibitor molecule on the NK     cells and reduced the cytotoxic activity of NK cells. So because of reduce the cytotoxic     activity of NK cells by IVIg in patients with RPL injection increases the likelihood of     successful pregnancy. Previous studies have shown that the incidence of genetic abnormalities     in children who have received immunosuppressive drugs such as IVIg like normal people and     normal society. In this study we used IVIg before IVF to suppress the immune system in     patients with immunological causes of RPL and the results will be compared with a control     group that did not receive any type of drug.   "
8491|NCT03174756|"     Hypochlorous acid (HOCl) in a non-antibiotic antimicrobial agent used in clinical medicine.     Nevertheless, its antiplaque oral effect has not been evaluated. Chlorhexidine (CHX) is the     gold standard as an antiplaque agent for its high substantivity in plaque and saliva. There     are no published studies evaluating the substantivity of hypochlorous acid compared to CHX.     Objective: To evaluate the efficacy of mouthwashes of HOCl in substantivity evaluated by     reduction of bacterial viability in saliva during 7 hours compared to CHX rinses and a     placebo.   "
8492|NCT03174743|"     The investigator will evaluate the influence of lung protective ventilation on postoperative     clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.   "
8493|NCT03174730|"     This study evaluates a new digitally delivered mindset based intervention in addition to a     smartphone application (app) for smoking cessation. Participants will be provided an app     (SmartQuit) that teaches them skills to quit, and will be randomly assigned to either receive     a growth mindset intervention or to a control group.   "
11668|NCT03133182|"     This study investigates the association of preoperative polypharmacy with outcomes and     healthcare resource utilization in a population-based sample of older patients enrolled in a     universal pharmacare program   "
8477|NCT03174938|"     The Swedish BioFINDER 2 study is a new study that will launch in 2017 and extends the     previous cohorts of BioFINDER 1 study (www.biofinder.se). BioFINDER 1 is used e.g. to     characterize the role of beta-amyloid pathology in early diagnosis of Alzheimer's disease     (AD) using amyloid-PET (18F-Flutemetamol) and Aβ analysis in cerebrospinal fluid samples. The     BioFINDER 1 study has resulted in more than 40 publications during the last three years, many     in high impact journals, and some the of the results have already had important implications     for the diagnostic work-up patients with AD in the clinical routine practice.      The original BioFINDER 1 cohort started to include participants in 2008. Since then there has     been a rapid development of biochemical and neuroimaging technologies which enable novel ways     to the study biological processes involved in Alzheimer's disease in living people. There has     also been a growing interest in the earliest stages of AD and other neurodegenerative     diseases. With the advent of new tau-PET tracers there is now an opportunity to elucidate the     role of tau pathology in the pathogenesis of AD and other tauopathies. The Swedish BioFINDER     2 study has been designed to complement the BioFINDER 1 study and to e.g. address issues     regarding the role of tau pathology in different dementias and in preclinical stages of     different dementia diseases. Further, the clinical assessments and MRI methods have been     further optimized compared to BioFINDER 1.   "
8478|NCT03174925|"     This clinical trial studies how well ultrasound elastography works in imaging patients with     thyroid nodules. Diagnostic imaging, such as elastography, uses shear waves to measure the     stiffness and compressibility of tissue and may be a better way to image thyroid nodules.   "
8479|NCT03174912|"     Investigators aimed to evaluate the performance of The European Organization for Research and     Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological     Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and     those not treated with BCG and treated with BCG separately.   "
8480|NCT03174899|"     Chronic kidney disease (CKD) is a common global public health problem and the average     incidence of end-stage renal disease in developing countries is 150 per million population,     which is lower than that in the developed world   "
12336|NCT03124160|"     This will be a multi-site, participant-blinded, randomized clinical trial. The investigators     will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to     Mona Lisa NT Cu380 Mini and 200 to ParaGard.   "
8482|NCT03174873|"     Ray and colleagues define unexplained infertility as failure to achieve pregnancy when the     semen analysis is normal, evidence for ovulation is present, and tubal patency has been     established. The efficacy of treatment declines with increasing age and duration of     infertility Infertility is a disease , defined by the failure to achieve a successful     pregnancy after 12 months or more of appropriate, timed unprotected intercourse or     therapeutic donor insemination, barber evaluation and treatment may be justified based on     medical history and physical findings and is warranted after 6 months for women over age 35     years.      In unexplained infertility abnormalities are likely to be present but not detected by current     methods including semen analysis in the man, assessment of the state of ovulation, ovulation     reserve and patency of uterine tubes in the woman.      unexplained infertility is not a rare item of infertility. Approximately 15% of infertility     couple will be diagnosed with unexplained infertility after their diagnostic workup Many     researches studied the laparoscopic tubal factor like tubo-ovarian relation, tubal kinks and     fimbrial pathology. But we need to scope on more tubal factors like fatty mesosalpinx ,     fimbria ovarica, methylene blue free spill and others   "
8483|NCT03174860|"     The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg     Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine     1:200,000 in mandibular molars with symptomatic irreversible pulpitis.   "
8484|NCT03174847|"     Majority of patients with hypertension have primary hypertension (without an underlying     cause). Secondary hypertension (due to an underlying disease) is important to recognize, as     treatment can lead to cure of hypertension. Primary aldosteronism (PA) is the most common     cause of secondary hypertension, and can be found in 5-10% of patients locally.      PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which     can be unilateral (one gland) or bilateral (both glands). Distinction between two is crucial     as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is     treated by medication.      It has been shown that excess aldosterone has other harmful effects in addition to     hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and     quality of life. This is supported by studies showing reversal of these effects after     treatment for PA. In addition, improvements after surgery appears to be superior to medical     treatment, although studies have found variable results.      Hence, the investigators aim to accurately subtype patients with PA into unilateral or     bilateral disease and study the post-treatment response after both surgery and medicine with     regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of     life.   "
8485|NCT03174834|"     Urinary tract infection is the most common serious bacterial infection among infants. Bladder     catheterization is considered the gold standard for diagnosis, yet is painful and invasive.     In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive     approach to collecting urine in young infants with a contamination rate similar to bladder     catheterization. Previous research, however, relied upon trained study personnel thereby     limiting the generalizability of their findings. By training staff in the pediatric emergency     department, this study aims to evaluate the feasibility of incorporating this technique into     routine clinical practice while also assessing its impact on parent and provider     satisfaction.   "
8486|NCT03174821|"     The recent study suggested that oxidative stress resulting from increased production of     reactive oxygen species (ROS) plays a crucial role in the development of diabetic     complications. The researches aim to monitor the level of oxidative stress of patient in     different stage of diabetic nephropathy before and after insulin pump therapy.   "
8487|NCT03174808|"     The primary objective is to assess the feasibly, adherence, and effects of mindfulness-based     stress reduction (MBSR) on anxiety and health-related quality of life in adult patients with     cutaneous T-cell lymphoma at the Yale Cancer Center/Smilow Cancer Hospital.      Participants will attend group sessions led by an instructor experienced in MBSR in an     academic setting. The mindfulness meditation group sessions will take place at the Smilow     Cancer Center at the Yale New-Haven Hospital.   "
8495|NCT03174704|"     Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death, affects     over 24 million people in the US and is the leading cause of disability with projected     healthcare costs at almost $50 billion. The goal of this study is to identify novel and     potentially powerful targets for behavioral interventions in COPD which has been understudied     despite its tremendous detrimental impact on overall public health.   "
8496|NCT03174691|"     Until now very little information exists regarding the early luteal serum progesterone     profile after Human chorionic gonadotropin (hCG) trigger. This pilot study will help     characterize the serum progesterone, 17-hydroxyprogesterone profiles in IVF patients and     correlate progesterone, 17-Hydroxyprogesterone levels to ovarian follicles obtained after     stimulation with exogenous gonadotropins.   "
8497|NCT03174678|"     The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral     dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the     young children underwent complete dental treatment.   "
8498|NCT03174665|"     To increase our understanding of pain mechanisms related to nerve injury and to enable early     clinical testing of new treatments in a frequent occurring clinical condition, we intend to     evaluate patients with spontaneous and/or evoked pain associated with upper extremity surgery     or other trauma affecting the radial, ulnar or the medial nerve, or branches of these nerves     such as digital nerves, and to compare them with patients who underwent same procedure for     same trauma without developing pain.We will determine the prevalence of neuropathic pain     after trauma and nerve surgery of upper extremity nerves. The patients with pain and without     pain will be further analyzed in respect to clinical differences, biomarkers and genetical     differences.   "
8499|NCT03174652|"     The global burden of maternal morbidity and mortality attributable to anemia is staggering,     and this is especially true in low-resource settings. A recent review suggests 42% of     pregnant women have anemia worldwide (1993-2005) with the vast majority of anemic women (90%)     residing in Africa or Asia1; and in Asia, anemia was the second highest cause of maternal     mortality2. Anemia was diagnosed in almost one third to one half of women presenting to the     Shoklo Malaria Research Unit (SMRU) clinics on the Thai-Myanmar border for antenatal care     (ANC) in a 2008 survey3, and anemia at first antenatal visit was associated with a two-fold     increase in maternal mortality in this population4. Studies have also shown an association     between anemia and small for gestational age infants, preterm delivery, infant and childhood     anemia and developmental delays5.      The anemia in pregnant women presenting to SMRU clinics is multifactorial, as     hemoglobinopathies, Glucose-6-dehydrogenase (G6PD) deficiency, iron, folic acid and B12     deficiency, helminth infection, and malaria are all prevalent in this rural population.     Though all of these pathologies can cause anemia, they require different and sometimes     conflicting treatment and prevention strategies, interacting in a complex web of causes and     effects. Iron supplementation is the mainstay of most anemia control programs, but some women     with hemoglobinopathies suffer from potentially fatal iron overload6. Iron supplementation     has also been associated with increased risk of malaria7. Some helminth infections are     associated with increased rates of anemia and malaria, but others may be protective8. Malaria     and G6PD deficiency have complex effects on one another, and some malaria treatments can     cause acute and life-threatening hemolysis in G6PD deficient individuals9.      Given the high prevalence and diverse causes of anemia in this population, and its     potentially dire effects on maternal and infant health and survival, SMRU implemented     increased clinical testing for pregnant women in 2012 to inform clinical care at the     individual level. Further analysis of these data is urgently needed to improve care on a     population scale. We propose to review existing data from ANC records to determine the causes     and effects of anemia in this population, and use this information to improve treatment and     prevention guidelines. Results would be integrated rapidly into local practice with the     potential to have profound impacts on maternal and child health in this region.   "
8500|NCT03174639|"     From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with     retinal detachment in high myopia treated with combined inverted and free ILM flap insertion     into the hole were retrospectively reviewed. The anatomical and function outcomes were     assessed.   "
8501|NCT03174626|"     The purpose of the pilot is to test the feasibility of developing and implementing the     Williams LifeSkills Cancer Care (WLSCC) and examining its preliminary impact on caregiver     well-being and patient well-being. The study is a two-arm randomized intervention pilot     (WLSCC vs. Usual Care [UC]) with data collection at baseline, immediately after training, and     2 weeks after completing the training. Study setting is at the breast and thoracic cancer     clinics at the Duke Cancer Clinic. A total of 40 cancer patients (20 breast cancer patients     and 20 lung cancer patients) and their caregivers (for a total N of 80) will be recruited for     the pilot. The WLSCC will involve six 30-minute phone sessions and will encompass the     application of 10 psychosocial skills within the context of cancer caregiving. Descriptive     statistics will be used to detail recruitment/retention rate, fidelity rate, and the baseline     demographic and clinical characteristics for the total sample and each group. Plots of the     individual trajectories (within-person scores over time) will be used to identify the     pattern(s) of change over time, and assess between-person variability in baseline values     (intercepts) and trajectories (slopes). This study carries minimal risk to study     participation.   "
8502|NCT03174613|"     1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects        2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in          healthy male subjects        3. To evaluate bioavailability of LC51-0255   "
8503|NCT03174600|"     The course of post-stroke bladder problems and their relation with functional, mental status     and quality of life: A six-month prospective, multicenter study   "
8504|NCT03174587|"     The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic     bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis.      Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.   "
8505|NCT03174574|"     Individuals who are affected with pancreas cancer and melanoma as well as those without     either cancer who have been identified as 1st or 2nd degree relatives of family members with     pancreas cancer and melanoma will be asked to participate. The participant will be asked to     complete a survey about their health and family history of cancer and to give a blood sample     for specific gene testing and storage for future research studies.The overall goal of this     study is to understand the factors that increase susceptibility and expression of pancreatic     cancer and melanoma in high risk families.   "
8506|NCT03174561|"     The study investigate the efficacy of the combination inuline, choline and silymarin in     alleviating the symptomatology of the patients with irritable bowel syndrome with     constipation in a randomized, cross-over, no treatment controlled study.   "
8520|NCT03174379|"     The purpose of this two-center study is to examine the effectiveness of acupuncture     treatments in addressing mobility deficits, sensorimotor impairment, and quality of life     (QOL) limitations in persons with Multiple Sclerosis (MS). It is hypothesized that     acupuncture will result in an improvement in these limitations.   "
8507|NCT03174548|"     Primary Objective:      To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative     to a fasted state in healthy adult male and female subjects.      Secondary Objectives:        -  To evaluate the effect of food on the single-dose pharmacokinetics of the main          metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult          male and female subjects.        -  To investigate the relative bioavailability of sotagliflozin tablet to oral solution          under fasting conditions        -  To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted          conditions in healthy adult male and female subjects.   "
8508|NCT03174535|"     The present study aims to develope a risk assessment model of ischemic stroke endpoint events     combining multi-dimensional traditional Chinese medicine(TCM) indicators with modern medicine     indicators. The proposed study is a registry study based participant survey conducted in 7     hospitals nationwide in China. After obtaining informed consent, a total of 3000 study     patients diagnosed with ischemic stroke will be recruited. 1-year follow-ups are carried out     on-site in hospitals and by telephone to track endpoint events.   "
8509|NCT03174522|"     This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial     conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to     assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of     Rexmyelocel‑T or matching placebo into the index limb.   "
8510|NCT03174509|"     Laboratory studies suggest extubation with positive pressure because it reduces the volume of     secretions filtered into the distal airway. The aim of this non inferiority study is to     evaluate the safety of the extubation technique under positive pressure with respect to the     traditional technique (with suction and without positive pressure in the airways).   "
8511|NCT03174496|"     This pilot study will investigate the feasibility of physical activity tracking in patients     aged 4-16 years before and after elective tonsillectomy as an innovative tool in paediatric     research. The participating patients will receive a wearable physical activity tracker     (CE-certified) that will continuously measure the patients' physical activity before and     after an elective tonsillectomy, in addition to their parents' documentation of their child's     activity in a conventional diary.   "
8512|NCT03174483|"     To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan     of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.   "
8513|NCT03174470|"     The company suggests a new concept of treatment for PE: Transient inhibition of striated     muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the     safety of delivering increasing electrical stimulation intensities to the subject's perineum,     using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.   "
8514|NCT03174457|"     The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when     prescribed for prophylaxis or treatment of fungal infections in different real-world clinical     conditions and centers, in pediatric patients in Asia/Oceania.   "
8515|NCT03174444|"     There have been few studies of small media interventions to promote colorectal cancer     screening among Chinese Americans. Based on the results of strong preliminary studies on the     promotion of colorectal cancer screening among Asian American populations, this     community-academic research team propose to develop a culturally and linguistically     appropriate traditional small media print brochure and a novel small media electronic     audio-visual application accessible through mobile applications and through a website to     promote CRC screening in English, Cantonese, and Mandarin. The team will test in a randomized     controlled trial in 3 healthcare systems the efficacy of a combination of these small media     interventions and a mailed patient reminder compared to usual care on increasing CRC     screening among Chinese American patients.   "
8516|NCT03174431|"     This is a multi-centered randomized controlled trial of women with stress urinary     incontinence or stress predominant mixed urinary incontinence who desire non-surgical     therapy.   "
8517|NCT03174418|"     Investigator-initiated, international, multicentre, observational study with two cohorts.      The two study cohorts will be:      Cohort A: to understand if the local blood flow patterns (associated with low WSS), as     evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive     images, may better predict the clinical outcome of patients with bifurcated coronary lesions     treated by PCI.      Cohort B: to understand if the local blood flow patterns (associated with low WSS), as     evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive     images, may better predict the clinical outcome of patients with sub-critical bifurcated     lesions managed conservatively.      Coronary angiography and OCT images will be combined to obtain a three-dimensional model of     the diseased coronary vessels that will be used to calculate the local blood flow patterns     and the time-averaged WSS at the bifurcated lesion level by using computational fluid     dynamics software.      Baseline (in patients both managed conservatively and treated by PCI) and post-PCI (in     patients treated by PCI) images will be processed.   "
8518|NCT03174405|"     AVETUX is a single arm multicentric phase II investigator initiated trial conducted by the     Arbeitsgemeinschaft Internistische Onkologie (AIO) in 11 German sites in patients with     previously untreated RAS/BRAF wildtype mCRC independent of MSI status.   "
8519|NCT03174392|"     Individuals poststroke with gait and balance impairment are typically less active and have     low levels of physical fitness. Improving fitness level while also improving gait and balance     is very important. Maximizing the exercise training benefit requires the appropriate level of     effort is achieved. Traditional exercise programs scale aerobic demand by increasing the     walking speed or the slope of the treadmill surface. This may be difficult for individuals     who experience decreased balance at faster speeds or on sloped surfaces and require the use     of handrails to safely walk under these conditions. These exercise programs show limited     improvement in walking ability after training. This project will test a novel approach,     resistance-based treadmill walking, for maximizing improvements in fitness and ability to     walk by individuals poststroke. The investigators previous research has shown that backward     directed resistive force applied to the pelvis while walking is well tolerated by individuals     poststroke. Further, these forces can be used to effectively scale aerobic demand while     walking in a controlled manner. With traditional treadmill training approaches handrail     support is utilized to ensure safety. However, handrail support externally stabilizes the     individual reducing training improvements in walking capacity and balance. For this pilot     investigation a group that aerobically trains using a standard exercise treadmill training     paradigm will be compared to a group that experiences progressive backward directed resistive     forces applied to an individuals' pelvis while they walk at comfortable walking speeds     without the aid of handrails. Individuals will wear a fall harness that provides no external     stabilization but prevents falls to the treadmill surface. This approach has the potential     benefit of allowing individuals poststroke to meaningfully practice walking at safe speeds     but against resistance thereby improving walking economy, dynamic balance, and walking speed.     The proposed project is necessary to gather preliminary data for a much larger training study     that has the potential to change the clinical approach for improving gait economy, balance,     and walking speed for individuals poststroke.   "
8521|NCT03174366|"     Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled     diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of     the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences     frequently lead to below-knee amputation of the affected limb.      Currently treatment options are limited, and no pharmaceutical treatment has been efficacious     in the medical literature. The purpose of this pilot study is to investigate the potential of     the medication denosumab for acute stage Charcot neuroarthropathy.   "
8522|NCT03174353|"     This is a single arm investigator-initiated study designed to test the feasibility and     potential efficacy of preoperative lanreotide to reduce the risk of postoperative abscess or     pancreatic leak and fistula. All consenting patients undergoing planned elective     pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy will     be treated with a single deep subcutaneous dose of lanreotide prior to planned resection on     the day of surgery. Following this intervention, care will be based on standard treatment     protocols. Sixty-day mortality and morbidity will be collected for all patients.   "
8523|NCT03174340|"     The main objective is to evaluate the effect of therapeutic exercise program on blood glucose     regulation in women with gestational diabetes mellitus (GDM) who are assigned to     diet-and-exercise, compared to diet only (usual treatment). The primary outcome is the need     for insulin treatment in the two groups.   "
8524|NCT03174327|"     Interventional study with minimal risks and constraints, prospective, mono-centric.   "
8525|NCT03174314|"     This pilot study will integrate multi-sensor fusion techniques (software) to effectively     combine information obtained from the newly embedded infrared, ultrasound, and     stereo-camera-based sensor systems (hardware) that are implemented into the VIS4ION platform.      The core of this technology is based on 4 components: (1) a wearable vest with several     distinct range and image sensors embedded. These sensors extract pertinent information about     obstacles and the environment, which are conveyed to (2) a haptic interface (belt) that     communicates this spatial information to the end-user in real-time via an intuitive,     ergonomic and personalized vibrotactile re-display along the torso. (3) A smartphone serves     as a connectivity gateway and coordinates the core components through WiFi, bluetooth, and/or     4G LTE, (4) a headset that contains both binaural, open-ear, bone conduction speakers     (leaving the ear canal patent for ambient sounds) and a microphone for oral     communication-based voice recognition during use of a virtual personal assistant (VPA).      Blindfolded-sighted (50), and blind (50) subjects in a real-world, combined obstacle     avoidance / navigation task will serve as an independent measure of overall improvements in     the system as well as a roadmap for future avenues to enhance performance.   "
8526|NCT03174301|"     The objective of this common multicenter protocol is to test the hypothesis that algorithmic     tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data     can detect ventilatory control instability and predict chronic and acute respiratory     consequences of ventilatory control instability and autonomic dysregulation.   "
8527|NCT03174288|"     In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR     blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade,     exercise or the combination of both interventions. The investigators will assess function in     conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI),     resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular     (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin     clamp.      We hypothesize that compared to healthy controls, both baseline and insulin-responsive     vascular function are impaired throughout the arterial vasculature by DM1 and that exercise     training and/or mineralocorticoid receptor (MCR) blockade will improve both baseline and     insulin-responsive pan-arterial function.   "
8528|NCT03174275|"     Participants in this study have a type of cancer called squamous cell carcinoma of the head     and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This     is called locally-advanced SCCHN. These participants are eligible for surgery.      Previous research with a similar therapy regimen resulted in high rates of cancer shrinkage,     high rates of avoiding radiation and its side effects, high cure rate and good quality of     life. Radiation can be very toxic. The purpose on this study is to try to avoid radiation. If     the participants are not on this study they would be receiving radiation as it is standard     treatment of their cancer. In the last study with a similar regimen, about a third of cancers     had a pathologic complete response with the first part of the study. This means that the     chemotherapy had killed the cancer. The investigators are trying to improve the regimen     further with a goal of increasing this rate of complete response to the first part of     therapy. The investigators also hope that by improving results in the first part, that more     people will be cured and that long term quality of life (especially speech and swallowing)     will be improved, both compared to standard therapies and to the last study. Doctors do not     know how this therapy will effect the participants. There is no guarantee that this study     will benefit the participants.      The prior study used a combination of chemotherapy consisting of carboplatin, paclitaxel and     a third targeted anti-cancer drug. In this study the investigators are testing the     combination of carboplatin, nano-albumin bound paclitaxel and durvalumab. Nano-albumin bound     paclitaxel has been shown to be more active against other types of squamous cancers than     regular paclitaxel. It is FDA approved for squamous lung cancer, but experimental for head     and neck cancer. Durvalumab is an experimental drug that uses the body's own immune system to     fight the cancer. Doctors hope that combining Durvalumab with 2 chemotherapy drugs will be     effective in treating SCCHN. Durvalumab on its own has been studied in patients with SCCHN     and initial results have shown that some subjects' cancer has responded to it.      The purpose of this study is to test a combination of chemotherapy to hopefully both increase     the number of subjects that respond to therapy while also decreasing the number of side     effects that subjects experience.   "
8529|NCT03174262|"     The study aims to determine whether a face to face ergonomic workstation intervention has any     advantage over an online instructional training program for acquisition of knowledge,     self-efficacy, and habit formation.   "
8530|NCT03174249|"     Consecutive patients with long-standing complex regional pain syndrome II in a lower limb are     treated with graded exposure therapy in vivo in combination with methods targeting cortical     reorganisation.   "
8531|NCT03174236|"     Children with severe malnutrition who are admitted sick to hospitals have a high     mortality(death rate), usually because of infection. All children with severe malnutrition     admitted to hospitals are treated with antibiotics(medication used to kill bacteria).     However, the current antibiotics used in hospitals may not be the most effective. It is     possible that the antibiotics that are currently used after initial antibiotics should be     used first. No studies have been carried out to determine if the current antibiotics used for     treating malnourished children who are sick and admitted in hospital are the most     appropriate. The aim of this study is to find out if a changed antibiotic system for children     with malnutrition is safe, reduces the risk of death and improves nutritional recovery.   "
10774|NCT03144882|"     Programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-CRP,     IL-6 and TNF-α accompanying with increases albumin levels in hemodialysis patients. Turmeric     can be considered as an effective anti-inflammatory supplement in hemodialysis patients.   "
8532|NCT03174223|"     Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during     various abdominal and non abdominal surgeries. It is however unknown if the application of     deep NMB leads to favourable outcome, such as lower rate of postoperative complications in     general and surgical infections in specific and ultimately lower readmission rates. In the     leiden university medical center, deep NMB is routinely applied for a variety of procedures,     most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro     radiologic intervention surgery, since 2014. This retrospective study intends to investigate     whether the application of deep NMB for these procedures affects patient outcome and     readmission rates.   "
8533|NCT03174210|"     The aim of this study is to investigate the effects of supplemental oxygen on blood     oxygenation at rest in Patients with severe to very severe COPD comparing the portable oxygen     concentrator (Activox™ 4L) to a liquid continuous oxygen device (Companion®).   "
8534|NCT03174197|"     There are 2 parts to this study: Part I and Part II.      The goal of Part I of this clinical research study is to study the safety and tolerability of     atezolizumab in combination with radiation therapy and temozolomide.      The goal of Part II of this study is to learn if atezolizumab combined with radiation therapy     and temozolomide can help to control glioblastoma.      The safety of this combination will also be studied.   "
8535|NCT03174184|"     The overall goal of this exploratory proof-of-concept study is to determine whether, in     participants with pulmonary tuberculosis caused by M. tuberculosis (MTB) with or without     rifampin resistance-conferring rpoB-gene mutations, the combination of meropenem and     amoxicillin/clavulanate with rifampin has greater early bactericidal activity (EBA) than the     combination of meropenem and amoxicillin/clavulanate without rifampin.   "
8536|NCT03174171|"     The overall objective is to evaluate everolimus as an aldosterone-lowering drug in the     treatment of primary hyperaldosteronism.   "
8537|NCT03174158|"     This study is a four arm pilot randomized controlled trial testing the effect of a 12 week     text messaging intervention and a mailed nicotine medication intervention, alone and in     combination to a control condition consisting of brief behavioral advice and usual care.      Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the     effect of a text messaging program and mailed nicotine replacement therapy on smoking     outcomes and medication use.      Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a     quit attempt compared to smokers receiving no text messaging.      Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement     therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy.      Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed     past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects     receiving no text messaging intervention.      Hypothesis 4: A text messaging intervention will increase the number of days not smoking     compared to subjects receiving no text messaging intervention.      Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per     day compared to subjects receiving no text messaging intervention.   "
8538|NCT03174145|"     The purpose of this clinical trial conducted in patients suffering from chronic pain is to     study the relationship between individual patients' profile and their analgesic response   "
8539|NCT03174132|"     The purpose of this study is to evaluate the pain and safety in associated with injection of     Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale   "
8540|NCT03174119|"     In this randomized, double-blind, placebo controlled project, the investigators would like to     assess the effect of a specific light, as compared to placebo light, on wakefulness     (circadian rhythms, homeostasy, sleep-wake cycle), awareness (perceptual and self     consciousness), cognition (attention, memory) and underlying brain activity     (electrophysiology and neuroimaging)   "
8541|NCT03174106|"     Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac     rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality     and risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The     main goal for CR is to establish exercise training and other lifestyle changes as permanent     changes in the patient's life. Many studies have shown that cardiac patients strive to     maintain a heart-healthy lifestyle, one year after participating in CR. Furthermore, this     leads to risk profile returning to the starting point where they got their Cardiac event.     Changing a lifestyle is known to take time, and we believe that the patients need further     follow-up beyond the time spent in traditional CR.      To our knowledge very few, if any, studies evaluates the use of modern technology in longterm     follow-up focusing on maintaining a new lifestyle after participating in CR. The     investigators would like to evaluate the effect of an dynamic application (app) with regard     to physical fitness, lifestyle and quality of life (QoL), one year after CR. The     investigators hypothesize that patients getting Access to a dynamic Application and tailored     feedback through the application after CR will better be able to take care of physical     Fitness and other lifestyle factors one year after CR, compared to patients getting usal     care.   "
8542|NCT03174093|"     This study will assess the benefits of using a mobile health application designed for shared     decision aid in anticoagulation therapy in patients with Atrial Fibrillation (AF). The aim is     to improve their treatment adherence and time in therapeutic International Normalized Ratio     (INR) range. The results of this study have the potential to lead to a sustainable and     resource-efficient strategy for better prevent thromboembolic events in patients with atrial     fibrillation.   "
8543|NCT03174080|"     Osteoarthritis (Osteoarthritis) of the knee is a high prevalence in the population of people     aged 60 years and over, when in some cases does not cause any discomfort or pain, and     therefore not diagnosed. In addition, Radio graphic findings of the knee not fully compatible     with the patient's symptoms, which resulted in errors in the interpretation and diagnosis.      In this study, patients who suffer from two knees or unilateral pain, will take part.     Participants will undergo a clinical examination, including evaluation of symptoms by an     orthopedist and an X-ray imaging, which are part of the currently accepted medical diagnosis.      Patients will perform PET-MRI test in order to assess whether PET MRI is a more efficient     tool for active knee osteoarthritis diagnosis.   "
15287|NCT03085368|"     This is a randomized controlled trial of HER-2 positive breast cancer patients treated with     lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous     anthracycline   "
8544|NCT03174067|"     This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal     to the emergency department to receive either one of clonidine (usual standard of care) or     buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid     access addiction medicine clinic within a few days of emergency room presentation. Secondary     treatment outcome is treatment status with respect to opioid agonist treatment at one month     post emergency room visit.   "
8545|NCT03174054|"     Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to     increased PSA levels or clinical suspicion, are false negative, despite malignancy.      Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging     devices.      A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of     malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells     and is shown to be a primary prostate tumor site in addition to metastasis.      We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI     test can lead to further improvement in malignancy, better biopsy guidance, and optimal     treatment for the patient.   "
8546|NCT03174041|"     The purpose of this study is to assess the potential for a drug interaction between GDC-0853     and midazolam, itraconazole, rosuvastatin, and simvastatin.   "
8547|NCT03174028|"     Anorectal malformations are congenital malformations, in which the terminal part of the     hindgut is abnormally placed and lies outside (partially or completely) the sphincter     mechanism.   "
8548|NCT03174015|"     This intervention will experimentally test the hypothesis that sanitation can be improved in     a peri-urban setting using state-of-the-art behaviour change communications.      Formative research indicated that landlords are the effective decision-makers about     investments in sanitation on their plots (which can include a number of tenant households as     well). Landlords will therefore be the primary targets of the intervention. The study will     take the form of a randomized controlled trial of the intervention evaluated at the plot     level. The intervention will invite enrolled landlords to a series of meetings in which     various mechanisms will be used, each designed to increase their likelihood of improving the     toilet(s) on their plot. These meetings will be the main vehicle for a status-building     campaign associated with increasing wealth by improving plot sanitation, understanding     tenants' implicit demand, understanding the processes by which toilets can be improved, and a     competition rewarding landlords that make the greatest improvements to the improvement of     their toilet(s). The desired improvements will be measured via multiple primary outcomes that     measure aspects of changes to hardware and software components, including indicators of     hygienic quality, psychological desirability, accessibility, and ecological sustainability.     This is because the investigators argue that, to have a significant impact on     population-level diarrheal disease indicators, any sanitation solution must be:        -  effective at reducing exposure to pathogens (i.e., hygienic),        -  desirable (i.e., seen as valuable or humane), and        -  accessible (i.e., no one excluded), so that it can be used by all        -  for a reasonably long time (i.e., sustainable)   "
8549|NCT03174002|"     Handling oxygenation targets (HOT) is standard of care in the intensive care unit (ICU),     however the quality and quantity of evidence is low and potential harm has been reported. The     aim of the HOT-ICU trial is to assess the overall benefits and harms of two levels of     oxygenation targets in adult critically ill patients with acute hypoxaemic respiratory     failure in the ICU.   "
8550|NCT03173989|"     Introduction: Osteoarthritis is a disabling disease that can affect 6% to 12% of the adult     population and more than a third of people over 65 years of age. Considering osteoarthritis     of hands, existing research about the therapeutic treatment advocates actions such as (1)     joint protection, (2) assistive technology and (3) exercises, however, doubts persist as to     their effects. Objective: To verify the functional and analgesic effect of joint protection     and energy conservation techniques, assistive technology (orthotics and adaptations) and     exercises in the treatment of patients with osteoarthritis of the hands. Method: An     epidemiological study in which a total sample of patients with knee osteoarthritis will     receive joint protection and energy conservation guidelines. Subsequently, the sample will be     divided into two groups, group 1 with radiological signs that suggest osteoarthritis of the     hands and 2 with patients with radiological signs and symptoms of osteoarthritis of the     hands, who present greater functional limitations in the daily life, being eligible for     treatment of Rehabilitation, in which will be used orthosis aiming at the relief of pain,     stabilization of the affected joints and the prevention of grievance of deformities and     orientations of exercises to maintain muscle strength. Participants will be followed up for     two years, evaluated with the Disabilities of the Arm, Shoulder and Hand questionnaire     (DASH), Stanford Health Assessment Questionnaire (HAQ), palmar grip strength measured with     Jamar dynamometer, key pinch strength, three point pinch strength and pulp pinch strength     measured with B & L Pinch-gauge dynamometer. The groups will be divided between 1 and 2, the     group 1 will be composed of patients who will only perform the orientations informed in the     theoretical and practical classes, while the group 2, besides the orientations will receive     orthoses with models such as volar hand rest splints, short thumb stabilization splints, and     volar finger splints with nocturnal support, aiming at the relief of the pain, stabilization     of the affected joints and the prevention of the appearance / aggravation of deformities.     Exercise guidelines for maintenance of muscle strength for thumb and fingers will be     performed on patients who present significant improvement of pain.   "
8551|NCT03173976|"     The purpose of this single arm open label phase 1b clinical study is to see what effect     zoledronic acid has on tumors in patients with resectable any grade chondrosarcoma prior to     surgery.   "
8572|NCT03173703|"     The purpose of this trial is to collect safety and effectiveness data to support peripheral     vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA     regulation in this kind of device. The clinical trial will be performed solely inside China     under GCP regulation and all applicable China regulations on medical device clinical trial.   "
8576|NCT03173651|"     60 Patients were randomly allocated into three equal groups, after induction of general     anesthesia one of the three airways included in the study (Modified Williams, Modified     Gudle's and LMA MADgic airway) was used as a conduit for endotracheal tube placement using     fiberoptic bronchoscopy. Airway insertion time, ease of insertion, adaptation to oral cavity     and intubation time was recorded.   "
8606|NCT03173261|"     Diagnosis of extra pulmonary tuberculosis remains especially challenging since the number of     Mycobacterium tuberculosis bacilli present in tissues at sites of disease is often low and     clinical specimens from deep-seated organs may be difficult to obtain. Histology is     time-consuming to undertake and establishing a diagnosis of tuberculosis with high     specificity remains difficult. Tissue microscopy after special staining is often negative and     when mycobacteria are seen, it is impossible to distinguish Mycobacterium tuberculosis from     non tuberculous mycobacterial disease. Reliance on culture, the mainstay of diagnosis, often     leads to considerable delays, compromising patient care and outcomes.      Evidence from 138 studies published before 2008 suggested that nucleic acid amplification     technologies could not replace conventional mycobacterial tests (microscopy, culture) for     diagnosing pulmonary and, especially, extra pulmonary tuberculosis   "
8553|NCT03173950|"     Background:      More than 130 primary tumors of the central nervous system (CNS) have been identified. Most     affect less than 1,000 people in the United States each year. Because these tumors are so     rare, there are few proven therapies. This study will test whether the immunotherapy drug     nivolumab is an effective treatment for people with rare CNS tumors.      Objectives:      To learn if stimulating the immune system using the drug nivolumab can shrink tumors in     people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors     to grow or spread.      Eligibility:      Adults whose rare CNS tumor has returned.      Design:      Participants will be screened:        -  Heart and blood tests        -  Physical and neurological exam        -  Hepatitis tests        -  Pregnancy test        -  MRI. They will lay in a machine that takes pictures.        -  Tumor tissue sample. This can be from a previous procedure.      At the start of the study, participants will have blood tests. They will answer questions     about their symptoms and their quality of life.      Participants will get nivolumab in a vein every 2 weeks for up to 64 weeks.      Participants will have monthly blood tests. Every other month they will have an MRI and a     neurologic function test. They will also answer questions about their quality of life.      Genetic tests will be done on participants tumor tissue. Participants will be contacted if     any clinically important results are found.      After treatment ends, participants will be monitored for up to 5 years. They will have a     series of MRIs and neurological function tests. They will be asked to report any symptoms     they experience.   "
8554|NCT03173937|"     Background:      Severe aplastic anemia (SAA) and myelodysplastic syndrome (MDS) are bone marrow diseases.     People with these diseases usually need a bone marrow transplant. Researchers are testing     ways to make stem cell transplant safer and more effective.      Objective:      To test if treating people with SAA or MDS with a co-infusion of blood stem cells from a     family member and cord blood stem cells from an unrelated donor is safe and effective.      Eligibility:      Recipients ages 4-55 with SAA or MDS      Donors ages 4-75      Design:      Recipients will be screened with:        -  Blood, lung, and heart tests        -  Bone marrow biopsy        -  CT scan      Recipients will have an IV line placed into a vein in the neck. Starting 11 days before the     transplant they will have several chemotherapy infusions and 1 30-minute radiation dose.      Recipients will get the donor cells through the IV line. They will stay in the hospital 3-4     weeks. After discharge, they will have visits:        -  First 3-4 months: 1-2 times weekly        -  Then every 6 months for 5 years<TAB>      Donors will be screened with:        -  Physical exam        -  Medical history        -  Blood tests      Donors veins will be checked for suitability for stem cell collection. They may need an IV     line to be placed in a thigh vein.      Donors will get filgrastim injections daily for 5-7 days. On the last day, they will have     apheresis: Blood drawn from one arm or leg runs through a machine and into the other arm or     leg. This may be repeated 2 days or 2-4 weeks later.   "
8556|NCT03173911|"     Elastic Bandaging Therapy (BET) is a technique that consists of the application of elastic     adhesive tape directed on a skin, and is used for pain reduction, improvement of flexibility,     postural alignment. It is believed that it can help proprioception by increasing or reducing     muscle tension by acting on motor coordination and balance. The present study aims to     evaluate the effect of the application of different BET strategies on the postural balance of     healthy young women through measures obtained through a proper instrument for a balance     assessment, a force platform.   "
8557|NCT03173898|"     The literature concerning the success and pain scores of PDL injection technique compared     with other techniques remains controversial; whereas some studies found no significant     difference in pain scores between local infiltration and PDL injection, other older studies     found that pain during administration of PDL injection was described by the majority of     patients either as greater than local infiltration6, or as negligible or as a less painful     injection compared with other injection techniques. The aim of this study was to evaluate the     efficacy of and patients' subjective responses to the PDL injection technique as compared to     the traditional infiltration injection, for the non-surgical extraction of one posterior     maxillary permanent tooth.   "
8558|NCT03173885|"     This is a two-arm parallel group randomized controlled trial at the Department of     Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age     undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts     remaining after fresh embryo transfer will be randomized to either transfer of a     cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of     a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).   "
8569|NCT03173742|"     Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18     mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing     fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing     (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios     do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose,     three-period crossover trial in healthy volunteers.   "
8570|NCT03173729|"     This is a-two phase study. Phase 1 will adapt a 3-metabolite biosensor that identifies     patients with colorectal cancer (CRC) and precancerous polyps to Nigerian patients. Phase 2     will pilot test and evaluate the point-of-care (POC) biosensor device in Nigeria.   "
8603|NCT03173300|"     Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG)      This is a natural history (observational) protocol designed to collect clinical and     biological information in patients with PMM2-CDG (CDG-Ia).      Data from this natural history study will be used to determine a set of clinical and     biological parameters that will be used for primary and secondary endpoints in a later     clinical trial with a new chemical entity, Lipo-M1P.   "
8604|NCT03173287|"     Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.   "
8670|NCT03172416|"     PIPAC is a procedure that involves the administration of intraperitoneal chemotherapy using     an innovative concept that enhances the efficacy by taking advantage of the physical     properties of gas and pressure. The chemotherapy drugs will be delivered in aerosolised form.     This results in a superior distribution and depth of penetration of the drug. This research     study serves to determine the safety profile and tolerability of PIPAC with oxaliplatin. It     may offer a novel and effective option of treatment for patients with peritoneal     carcinomatosis, who, at present have limited options involving the use of systemic     chemotherapy and who suffer from poor life expectancy and poor quality of life.   "
8559|NCT03173872|"     For the past few years, the military has been looking for an innovative way to decrease the     use of opioids for chronic pain. This has prompted military treatment facilities to begin     integrating complementary and/or alternative medicine modalities into their conventional     plans of care. Reiki, a bio-field energy therapy, is one such modality. The purpose of this     prospective repeated measure study is to: 1) introduce the concept Reiki therapy to military     healthcare beneficiaries experiencing chronic pain, 2) assess pain outcome after receiving     six treatments of Reiki therapy, and 3) assess participant's impression of Reiki therapy as a     possible complementary and/or alternative option for the management of chronic pain.      Thirty military healthcare beneficiaries with the complaint of chronic pain will receive a     brief introduction to Reiki therapy followed by six 30-minute Reiki sessions provided by     trained Reiki Level 1 Practitioner. Participant's knowledge of Reiki will be assessed using     pre and post questionnaires; pain will be assessed using the Brief Pain Inventory, Defense     Veterans Pain Rating Scale, DoD (Department of Defense) VA (Veteran's Administration) Pain     Supplementary Questionnaire, McGill Pain Questionnaire and pain medication diaries; and     participant's impression will be assessed using the Patient Global Impression of Improvement     Scale and along with a post study questionnaire. If it is found that Reiki therapy helped in     decreasing chronic pain outcomes, this treatment modality may be added to Landstuhl Regional     Medical (LRMC) Pain Clinic's pool of complementary and alternative medicine options.   "
8560|NCT03173859|"     A randomized phase II study comparing the sequential use of abiraterone followed after     progression by apalutamide with alternating cycles of abiraterone and apalutamide   "
8561|NCT03173846|"     This study aims to predict cognitive decline using a performance endophenotype of     neuro-feedback based on functional magnetic resonance imaging in real time in a population at     risk for Alzheimer's disease (AD).   "
8562|NCT03173833|"     The aim of phase 1 of this study is to develop a care need scale (CNS) for adolescents with     cancer. The aim of phase 2 is to examine the mediating role of care needs between physical     and psychosocial dysfunction and QoL, and to explore the recovery trajectory and its     predictors regarding the care needs, physical and psychosocial factors, and the QoL of     adolescents with cancer at the first, second, and third 3-month periods after initiating     on-treatment and off-treatment. The aim of phase 3 is to examine the effectiveness of the     computerized assessment with graphic outcome (CAGO) for fulfilling the care needs of     adolescents with cancer, its acceptability for adolescents with cancer, and its usability for     clinicians in pediatric oncology units.   "
8563|NCT03173820|"     Kidney transplantation is the most appropriated treatment in end stage renal failure patients     in order to improve quality of life. However, patients have to take immunosuppressive drugs     to prevent graft rejection. Tacrolimus is the most common immunosuppressive drug used now.     However, tacrolimus has narrow therapeutic level and needs regularly therapeutic monitor     because of inter-individual variation in dosage regimen. Not only age, body weight and drug     interaction but also genetic factor in metabolic pathway of tacrolimus plays an important     role in tacrolimus blood level. Previous data showed CYP3A5 genetic polymorphism was     significant effect tacrolimus blood level. From previous study showed the mean dose of     tacrolimus required for the induction phase was significantly higher (P= 0.006) in the     CYP3A5*1/*1 group at 0.142±0.050 mg/kg/day than that required by patients who carried either     the CYP3A5*1/*3 group of 0.097±0.040 mg/kg/day or the CYP3A5*3/*3 group of 0.077±0.020     mg/kg/day. Tacrolimus maintenance dose required for CYP3A5*1/*1 group of 0.12±0.03 mg/kg/day     was 1.3 times higher (P<0.0001) than used for the CYP3A5*1/*3 at 0.09±0.03 mg/kg/day and 2.4     times higher than the CYP3A5*3/*3 group of 0.05±0.02 mg/kg/day. Therefore, the investigators     plan to investigate a prospective study to determine the clinical outcome of tacrolimus     treatment in kidney transplant recipients between genotype guided dosage regimen group and     conventional group.   "
8564|NCT03173807|"     The purpose of this study is to test the feasibility of nutrition and exercise counseling     program for reducing the incidence of metabolic syndrome in prostate cancer patients on     Androgen Deprivation Therapy.   "
8565|NCT03173794|"     The goal of this research program is to reduce health disparities by deploying an     information-based intervention to increase caregiver utilization of community-based food     supports and satisfaction with care among food insecure caregivers of hospitalized children.     We will conduct a randomized controlled trial to evaluate, versus usual care, the effects of     the CommunityRx-H intervention on caregiver use of food resources (primary), caregiver     patient satisfaction with care (primary), caregiver mental health-related quality of life     (secondary), and caregiver household food security (secondary). The proposed research will     yield an understanding of how to leverage a child's hospitalization to effectively intervene     on the problem of food insecurity. Findings will inform the rapidly growing field of     healthcare-based interventions to address health-related social needs.   "
8566|NCT03173781|"     The purpose of this study is to determine if droxidopa reduces fall risk by improving gait     speed, kyphosis, and functional reach in individuals with Parkinson's disease.   "
8567|NCT03173768|"     A quasi-experimental study was conducted among patients receiving care at the medicine units     of the Maharaj Nakorn Chiang Mai Hospital to determine the appropriateness of intravenous     antibiotics at hospital discharge with and without ID consultation.   "
24677|NCT02962674|"     The purpose of this study is to evaluate the safety and performance of the ProstaCare System     in relieving symptoms of urinary outflow obstruction secondary to benign prostatic     hyperplasia.   "
8573|NCT03173690|"     This study evaluates the effect of performing medicines reconciliation on patients admitted     to an intensive care unit. Half of the patients will receive a medicines reconciliation at     the intensive care unit. The other half will not. All included patients will receive     medicines reconciliation after transfer to the ward.   "
8574|NCT03173677|"     Macrophages can exhibit distinct phenotypes and functions in response to stimuli and can     polarize into one of three distinct phenotypes: a pro-inflammatory (M1), an anti-inflammatory     pro-tissue (M2) and metabolically-activated (MMe) macrophage phenotypes. Thirty-six healthy     volunteers were recruited and randomized into one of three macronutrient intake groups     (glucose, lipids, proteins). This study measured the effects of macronutrient intake on the     macrophage differentiation.   "
8575|NCT03173664|"     KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye.     The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.   "
8577|NCT03173638|"     In this study the investigators propose to perform a Phase II Clinical Trial which seeks to     evaluate the safety of cell therapy as a new treatment for patients who suffer from acute     non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study     to assess efficacy will be performed.      This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results     in blindness. Currently, there is no available treatment and second eye involvement occurs in     approximately 15-25% of the cases.      All this background originates a particularly dramatic outcome for the patient. Therefore, it     seems justified to evaluate new therapies that maintain or improve the visual function in     these patients.      The Project includes a clinical trial whose purpose is the assessment of the safety of     intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION,     a product in clinical research phase (PEI No. 15-007) already approved for other human     clinical applications (PEI No. 15-007).      It can be considered that the therapy with intravitreal injection of MSC is a treatment     option in patients with acute NAION, since through the paracrine properties of these cells     (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or     reduce the progression of axonal degeneration caused by this disease.   "
8578|NCT03173625|"     The main objective of the study is to investigate the safety and tolerability of single     ascending doses of AC-076 administered as subcutaneous injection   "
8579|NCT03173612|"     The purpose of this study is to evaluate that whether the AML (acute myeloid leukemia)-CAMS     (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the     use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML.   "
8580|NCT03173599|"     A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir     Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted     in Chinese Healthy Adult Volunteers.   "
8581|NCT03173586|"     This study is a secondary analysis of data collected in the Nurses' Health Study (NHS) that     will evaluat the association between intake of sugar sweetened beverages (SSB), juice and     artificially sweetened beverages in relation to biomarkers of hepatic function, lipid     metabolism, inflammation and glycemic control.   "
8582|NCT03173573|"     This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose     escalation study in healthy male participants. Part 2 is a single dose, open-label study in     healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in     healthy female participants. Part 4 is a randomised, double-blind, placebo-controlled,     dose-escalation study in healthy male and female participants.Part 5 is a single dose,     open-label study in male and female participants with CF.   "
8583|NCT03173560|"     Study E7080-G000-218 is a Randomized, Double-blind, Phase 2 Trial conducted to assess whether     a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once     daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24     weeks [ORR24W]) with an improved safety profile compared to lenvatinib 18 mg in combination     with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any ≥ Grade 3     adverse events (AEs) in the first 24 weeks after randomization).   "
8584|NCT03173547|"     The objective of this study is to determine and compare the safety and efficacy of topical     146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to     severe ichthyosis vulgaris (IV).   "
8585|NCT03173534|"     To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN     Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF)     undergoing transcatheter aortic valve replacement (TAVR).   "
8586|NCT03173521|"     This study investigated the safety and efficacy of gene therapy approaches for     Mucopolysaccharidosis type VI disease caused by the deficiency of arylsulfatase B (ARSB)     enzyme. The aim of the study is to evaluate the safety and efficacy of the treatment.   "
8587|NCT03173508|"     This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right     ventricular function at acute altitude exposure in patients with COPD.   "
8599|NCT03173352|"     Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated     incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related     epidemiological data remains unclear. So, the investigators designed the study for the     following purposes: 1, to aware the incidence of infantile hemangioma and understand the     related risk factorsin China; 2, to understand the clinical characteristics of infantile     hemangioma and the risk factors for complications; 3, to investigate the level of knowledge,     treatment options in infant hemangioma in Chinese doctors; 3, to improve the awareness of     infantile hemangioma in parents and provide more advice for pregnancy counseling and     eugenics.   "
8600|NCT03173339|"     This investigation is planned to compare the incidence and severity of postoperative sore     throat according to the dose of remifentanil.   "
44122|NCT02708160|"     This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to     evaluate remineralization of early caries lesions.   "
8605|NCT03173274|"     The purpose of this study is to investigate the feasibility of a mobile-phone based     contingency management (CM) intervention for smoking in low-SES women. The CM intervention     will be combined with a Brief Motivational Interviewing (BMI) counseling component. This     study will examine the following research aims:      Primary Aim: To compare the effects of a Brief Motivational Intervention (BMI) + mobile     phone-based CM on tobacco use when compared to BMI with a non-contingent control condition in     a small feasibility trial.      Hypothesis: The investigators expect women in the BMI + CM condition to have more smoke free     days than women in the BMI + NC condition.      Secondary Aim: To examine alcohol use as a moderator of cessation outcomes.   "
8644|NCT03172754|"     This is a Phase I/II, open-label, multi-center study of axitinib in combination with     nivolumab in patients with previously treated and untreated advanced RCC. This clinical study     will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases     (Phase II). The dose finding phase will assess the safety of the combination and establish a     recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable     by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have     received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy     of the combination at the RP2D in two parallel expansion cohorts in both previously treated     and treatment naïve patients.   "
8588|NCT03173495|"     Cardiovascular Diseases (CVDs) are the leading causes of death in the world and in Brazil. In     2001, 12.45 million deaths on the globe (21% of the total) were caused by some CVD.      The composition of modern man's diet has changed drastically with the industrialization of     food, resulting in the transition from a diet rich in fibers and complex carbohydrates to one     with a high content of sugars and fats. Since the current dietary pattern is characterized by     the consumption of three or more meals a day, containing a quantity of fat in the range of 20     to 70 g, individuals spend a large part of the day in the postprandial state, with continuous     fluctuation of lipemia Over 18 hours. Food intake (postprandial state) is the dynamic,     unstable response of the body that refers to rapid hormonal and lipoprotein remodeling. It is     well established in the literature that high-fat meals (lipid overload) cause an increase in     plasma triglycerides. Hypertriglyceridemia and / or elevated triglyceride-rich lipoproteins     (LRT) (chylomicrons, VLDL and their remnants) in the postprandial state induces endothelial     dysfunction via increased oxidative stress and is an independent risk factor for CVDs.     Therefore, Postprandial Lipemia (PPL) is counted as an early marker of atherosclerotic     process, metabolic abnormalities and endothelial dysfunction.      High-carbohydrate (CHO) diets may promote increased LDL-c, TG, VLDL and HDL-c reduction, as     well as PPL, generating a lipid profile associated with an increased risk of CVDs. This     effect appears to be more pronounced with the inclusion of simple carbohydrates (mono and     disaccharides), although it also occurs with diets rich in complex carbohydrates     (polysaccharides).      High fructose diets (HFDs) are a known model of induction of insulin resistance, dyslipidemia     and DM2 in primates and humans. The chronic effect of fructose consumption has been well     studied in the last decades due to its connection with obesity, resistance to Insulin,     accumulation of visceral fat and dyslipidemia.      As the consumption of fructose is progressively increasing in society and its chronic     exposure can generate a phenotypic effect of dyslipidemia and, consequently, the increased     risk of CVDs, prevention and treatment strategies should be seen as an important public     health issue . Thus, the objective of this study is to understand the effects of exercise on     fat metabolism, since there is a lack of robust evidence about the possible cardioprotective     and hypolipemic role of the same on HFD.   "
8589|NCT03173482|"     Cesarean section on demand: defined as a primary cesarean section performed at the mother's     request to avoid a vaginal birth, without any recognized medical or obstetric indication. The     medical field now acknowledges a patient's right to actively participate in her choice of     medical treatments, including method of delivery.      There are many reasons for a cesarean section on demand: fear of delivery, fear of pain,     family pressure, a previous bad experience, more control over events, improved care, and     maintaining the integrity of the pelvic floor. of the pelvic floor.   "
8590|NCT03173469|"     all female with operable breast cancer seeking health care at general surgery department     Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on     clinical examination, findings on mammography and sonography, will undergo MRI breast, and     see if MRI finding will change decision of the surgery.   "
8591|NCT03173456|"     This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg     acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen,     400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for     the treatment of patients with acute musculoskeletal pain who present to the Emergency     Department (ED).   "
8592|NCT03173443|"     One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus     surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube     (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker;     (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with     SLT is well established technique for anticipated or unexpected difficult intubation. But,     little is known about flexible fiberoptic intubation with DLT.      The investigators compared insertion time over fiberoptic bronchoscope between SLT with     bronchial blocker and DLT in patients undergoing thoracic surgery.   "
8593|NCT03173430|"     This study involves receiving blinatumomab after high-dose melphalan and ASCT for multiple     myeloma. The main purpose of this study is to: - To determine whether blinatumomab is safe     and feasible to administer after ASCT in patients with advanced multiple myeloma. - To assess     how long multiple myeloma remains under control when blinatumomab is administered after     second ASCT.   "
8594|NCT03173417|"     Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19     Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.   "
8595|NCT03173404|"     This is a prospective randomized open-label trial. Women scheduled for their first or second     in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no     abnormality detected in transvaginal ultrasound examination, were randomized to two groups.     In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle     while in the second group (group II) 37 patients underwent direct cycle without previous     hysteroscopy   "
8596|NCT03173391|"     This study evaluates the efficacy and safety and population PK of HMS5552 as add on to     Metformin in type 2 diabetic adult subjects, there will be 2 groups in the first 24 weeks,     one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks,     all subjects received HMS5552 for 28 weeks.   "
8597|NCT03173378|"     Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness     and, in some patients, falls in muscle tone related to emotions (cataplexies). It often     begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an     important handicap in everyday life, and are often misunderstood by the family and     professional environment. In addition, many comorbidities are associated with narcolepsy,     such as depression, anxiety, or obesity.      Few studies have examined the impact of narcolepsy on patients' educational background,     socio-professional integration, and quality of life. In particular, the factors of     professional handicap related to the characteristics of the disease and the determinants of     the insertion of the patients remain poorly known.      As a better understanding of these determinants could help to inform patients and guide them     in their choices, NARCOWORK study aims at evaluating the academic and professional     trajectories of a wide population of narcoleptic patients.   "
8598|NCT03173365|"     Comparative analysis of the severity of Hand-Foot-Syndrome (HFS) of palms treated with     brimonidine tartrate gel or with standard care Urea 10% containing lotion in cancer patients     receiving antineoplastic therapy to show a preventive effect of cutaneous brimonidine     treatment on severity of HFS symptoms.   "
8601|NCT03173326|"     The study evaluates the efficacy of two different anesthetic techniques in patients     undergoing unilateral knee arthroscopy. Participants will be randomized to receive either     subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.   "
8602|NCT03173313|"     The objective of this trial is to evaluate the safety and effectiveness of therapeutic     hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients     presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous     coronary intervention (PCI).   "
8607|NCT03173248|"     Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized,     placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib)     + azacitidine vs placebo + azacitidine in adult subjects with previously untreated IDH1m AML     who are considered appropriate candidates for non-intensive therapy. The primary endpoint is     Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS),     rate of complete remission (CR), Rate of CR and complete remission with partial hematologic     recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based     on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo,     both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An     estimated 392 subjects will participate in the study.   "
8608|NCT03173235|"     1,25-dihydroxy-vitamin D3 (1,25 (OH) 2D3) or calcitriol regulates plasma calcium and     phosphate concentrations in the blood by stimulating intestinal absorption and renal     reabsorption of calcium and phosphate. 1.25 (OH) 2D3 is formed by the renal 1α25OH vitamin     D-hydroxylase (Cyp27b1) and inactivated by the renal 25-hydroxy vitamin D-24-hydroxylase     (Cyp24). Unpublished studies in mice revealed an inhibitory effect of 1.25 (OH) 2D3 on embryo     implanation. An excess of 1.25 (OH) 2D3 could therefore lead to female infertility. The     excess of 1.25 (OH) 2D3 could result from uncritical vitamin D intake with insufficient     negative feedback by FGF23 / Klotho. The aim of the study is to identify patients with an     excess of 1.25 (OH) 2D3.   "
8609|NCT03173222|"     This study aims to prove the efficacy of electroacupuncture (EA) for pain relief in patients     with acute pancreatitis compared with conventional treatment. Patients diagnosed with acute     pancreatitis will be enrolled after obtaining informed consents. They will be randomly     assigned to EA 1, EA 2, or control group in a 1:1:1 ratio. All the enrolled patients will     basically receive the conventional standard-of-care therapy for acute pancreatitis. Local     electroacupuncture will be given in group EA 1, while local with distal electroacupuncture     will be given in group EA 2, additionally. For the conventional therapy, first non-steroidal     anti-inflammatory drugs will be administered; afterwards, if inadequately controlled,     low-potency narcotic analgesics such as codeine and then high-potency narcotic analgesics     such as morphine or meperidine will be given sequentially as required. The patients     randomized to the EA 1 and 2 groups will undergo 1 session of electroacupuncture daily from     day 1 until day 4, or until pain is resolved. The primary endpoint is the visual analogue     scale (VAS) for pain on day 5. Secondary endpoints include daily VAS, requirement of     analgesics, changes of inflammatory markers, and hospital days.   "
8610|NCT03173209|"     We explored the meaning and outcomes of a 4-month program designed to build capacity of     school personnel in implementing evidence-based strategies for reducing stress and promoting     mental well-being among students in school settings. A one-group (N 93) mixed-methods design     using a pretest-posttest survey and qualitative analysis of their written reactions was used     to explore the meaning and outcomes of the Calm Moments Cards program.   "
8611|NCT03173196|"     The patients of the group sepsis are measured several times with the non-invasive     multi-spectral sonography (Sonovum ACG-Diagnosesystem) (days 1, 3, 7 and 14). The patients     of the group control are measured on days 1 and 3 with the system. A measurement takes 3     minutes. For this purpose two ultrasound heads are placed above the patient's ears and fixed     with an all-head harness. The device is certified for CE application. There are no known     health risks of ultrasound in humans.   "
8612|NCT03173183|"     This is a randomized double-blind placebo controlled trial aim to compare the efficiency of     genuine regional and non-genuine regional Rhizoma Atractylodis in treating functional     dyspepsia. This study will also observe the clinical safety of genuine regional Rhizoma     Atractylodis.The trial will be conducted in Xiyuan Hospital of China Academy of Chinese     Medicine Sciences and Dongzhimen Hospital of Beijing University of Chinese Medicine.   "
8613|NCT03173170|"     The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor     itraconazole on the single-dose PK of TAK-954.   "
8614|NCT03173157|"     The investigators hypothesize that a combined didactic and data feedback program presenting     evidence based indications and in-hospital-charges for echocardiograms to inpatient     cardiology team members will lead to increased health care value for patients on inpatient     cardiology teams.   "
8637|NCT03172845|"     To determine the clinical relevance of vulnerable plaque using OCT in patients with coronary     bifurcation lesion.   "
8615|NCT03173144|"     Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease     and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis,     psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and     non-infectious uveitis are treated with biologics targeting the pro-inflammatory molecule     tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do,     however, not respond to biologics and lifestyle is assumed to affect the treatment outcome.     However, little is known on the effects of lifestyle as a prognostic factor (possibly     enabling personalised medicine). The aims of this multidisciplinary collaboration are to     identify lifestyle factors that support individualised forecasting of optimised treatment     outcome on these costly drugs.      This prospective cohort study will enrol CID patients assigned for TNF-α inhibitors. At     baseline (Pre-treatment), patient characteristics are assessed using patient-reported outcome     measures and clinical assessments on disease activity, quality of life, and lifestyle     together with registry data on comorbidity and medication. Follow-up will be conducted at     week 14-16 after treatment initiation (according to the current Danish standards). Evaluation     of a successful treatment outcome response will - for each disease - be based on most     frequently used primary endpoints; the major outcome of the analyses will be to detect     differences in treatment outcome between patients with specific lifestyle characteristics.      The overarching goal of this project is to improve the lives of patients suffering from CID,     by providing evidence to support dietary recommendations likely to improve the clinical     outcome.      The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency     (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient     associations, and presented at national and international conferences.   "
8616|NCT03173131|"     This is a randomized controlled study that will involve fellowship-trained board certified     orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder     and elbow surgery, and foot and ankle surgery) within our practice group. Consenting patients     will be randomized to the treatment group (receiving preoperative counseling) or to the     control group (no preoperative counseling). The control limb will provide us with information     regarding average opioid consumption following common outpatient orthopedic procedures, and     the study limb will allow us to evaluate the effect of the pre-operative opioid counseling.   "
11669|NCT03133169|"     The study will investigate the relation between erythrocyte glutamine/glutamate ratio and     pulmonary hypertension risk in Egyptian thalassemic children in Assiut University Children     Hospital   "
8617|NCT03173118|"     Chronic pancreatitis is a progressive inflammatory condition where progressive fibrosis and     calcification results in loss of physiological pancreatic function (both endocrine and     exocrine). The structural, fibrotic changes of chronic pancreatitis can only be seen in     advanced disease with conventional radiology tests and the diagnosis of chronic pancreatitis     early in the disease course remains challenging. Early diagnosis and treatment of chronic     pancreatitis can prevent the complications of pain and malnutrition and improve the quality     of life of patients. Endoscopic ultrasound (EUS) has recently become a favoured method for     diagnosing early structural fibrotic changes of chronic pancreatitis in clinical practice;     however this technique is subjective with sub-optimal intra-observer agreement. A new     technique called elastography, performed during EUS, quantitatively measures tissue stiffness     which may give more reliable results. This study aims to assess whether EUS elastography can     accurately identify for chronic pancreatitis.      Patients referred for EUS examinations will be identified and recruited prospectively. The     investigators will perform endoscopic ultrasound examinations with elastography readings in     two groups of patients: those referred for EUS with suspicion of chronic pancreatitis and     those referred for EUS for assessment of abdominal pain without risk factors or any other     tests suggesting chronic pancreatitis. The elastography readings will then be compared to the     gold standard which is a composite evaluation including standard EUS examination using     morphological appearance (Rosemont classification), and other tests already performed     including cross-sectional imaging (MRCP and CT), patient history and faecal pancreatic     elastase (FEL-1).      Patients will be identified and data collected prospectively. There is no randomization or     blinding involved in the study as the endoscopists will need to be aware of the indication     for referral in order to carry out a complete examination.   "
8618|NCT03173105|"     Postural control requires the integration of the vestibular, visual and somatosensory     systems. Vision, in particular, exerts a considerable influence on body sway during     activities that require balance. The investigators aimed to analyze the effects of     transcranial direct current stimulation (tDCS) combined with proprioceptive exercises on     postural control in individuals between 18 and 55 years old, with congenital and acquired     blindness.      Intervention will occur in three phases: 1 - Determine differences in postural control and     gait between individuals with congenital and acquired blindness with and without the use of a     guide stick when wearing shoes and when barefoot; 2 - Analyze the effect of anodal tDCS over     three areas of the brain (primary motor cortex, somatosensory cortex and visual cortex) on     postural control and gait; 3 - A treatment protocol will be conducted in which the     participants will be allocated to four groups: G1 - active tDCS + dynamic proprioceptive     exercises; G2 - sham tDCS + dynamic proprioceptive exercises; G3 - active tDCS + static     proprioceptive exercises; and G4 - sham tDCS + static proprioceptive exercises.      Evaluations will involve a camera system for three-dimensional gait analysis, a force plate     to measure the postural control, and electromyography to analyze the muscles activities.     Dynamic stability will be determined using the Timed Up and Go test and static stability will     be analyzed with the aid of the force plate.      The viability of this study will allow the determination of differences in postural control     between individuals with congenital and acquired blindness, the analysis of the effect of     tDCS on postural control and the establishment of a rehabilitation protocol.   "
8619|NCT03173092|"     The purpose of this study is to determine the progression-free survival (PFS) at 2 years for     multiple myeloma (MM) participants previously receiving a bortezomib-based induction regimen     to ixazomib in combination with lenalidomide and dexamethasone (IRD).   "
8620|NCT03173079|"     A geriatric assessment is becoming increasingly important in the treatment of patients with a     percutaneous aortic valve replacement due to their comorbidities. The aim of this multimodal     therapy concept is to examine the influence on the postoperative outcome. In addition to a     comprehensive assessment of the individual frailty score, the subjective condition before and     after TAVI is also evaluated using a standardized questionnaire (Minnesota living with heart     failure questionnaire).   "
8621|NCT03173066|"     This proposal is based on findings from our previous work involving ferumoxytol-enhanced     cardiac magnetic resonance angiography. The resolution of the pulmonary vasculature based on     our previous imaging protocol was exceptional (PMID: 26786296). In the Partners Healthcare     System between January 1, 2014 and January 1, 2015 there were 541 patients evaluated in     Partners Healthcare-affiliated hospitals with a diagnosis of pulmonary embolism and acute or     chronic kidney disease at the same visit between 01/01/2014 and 01/01/2015. Ventilation     perfusion scanning was performed in 201 patients during this same time interval. Up to 63% of     these patients in one year did not receive the diagnostic test of choice.   "
8622|NCT03173053|"     This trial focusses on identifying the most effective and safe long-term S. aureus carriage     decolonization strategy in home parenteral nutrition patients. Half of the participants will     receive a quick and short systemic antibiotic treatment combined with topical treatment,     while the other half will receive only topical treatment on a periodic basis.   "
8698|NCT03172052|"     interventional randomized clinical trial will be done at Assuit University Hospital ( Chest     Department and Caridothoracic surgery department ),and all patients presented with complex     septate pleural effusion in whom the symptoms excepted to be relieved by pleural fluid     drainage will be included in our study within the two next years.   "
8623|NCT03173040|"     Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory autoimmune disease that     results in the destruction of joints, connective tissues, muscle, tendons and fibrous tissue.     Effective therapy to manage RA still does not exit at present. Jia Wei Niu Bang Zi pill     (NBZP) consists of Chinese herbals which has been widely used in the treatment of RA patients     in China for hundreds of years to relieve pain and prevent the affected joints pejorative.     However, there is no systematic trials to prove the effect of NBZP for management of RA.   "
8624|NCT03173027|"     Knee osteoarthritis (KOA) is known as degenerative joint disease, which is the most common     form of arthritis and the leading cause of disability, loss of function and pain worldwide.     Effective therapy to manage RA is still lack at present. Fangji Huangqi pill (FHP) is a     Chinese medicine which has been widely used in treating KOA in China for hundreds of years to     relieve pain, reduce swelling and protect the affected joints from further degeneration.     However, no certain evidence to show the effect of FHP for the management of active KOA.   "
8625|NCT03173014|"     EEG in moyamoya disease in children preoperatively   "
8626|NCT03173001|"     Colorectal cancer (CRC) has the third highest cancer incidence in the world. There is     mounting evidence that the intestinal microbiota plays an important role in colorectal     carcinogenesis. but there is no information on protozoa of intestinal microbiota except     Blastocystis hominis, although data on this issue is scarce. In this study we are going to     evaluate the prevalence of intestinal helminthes and protozoa in CRC patients and control     group that includes random residents. Patients will be examined before, after surgery and     chemotherapy. Parasites and protozoan infection intensity will be estimated by triple     coproscopy.   "
8627|NCT03172988|"     Surgical resection is the first choice treatment for patients with non-small-cell lung     cancer. Despite of advances in surgical techniques, the long-term survival rate of     postoperative patient is far from optimal. In a recent retrospective cohort study of the     applicants, 588 patients after surgery for non-small-cell lung cancer were followed up for a     medium of 5.2 years. The results showed that perioperative use of dexamethasone was     associated with prolonged survival; perioperative use of flurbiprofen axetil was also     associated with a slightly longer survival but not statistically significant. Further     analysis showed that combined administration of dexamethasone and flurbiprofen axetil had     additive effect in prolonging survival. We hypothesize that, for patients undergoing surgery     for non-small-cell lung cancer, perioperative administration of dexamethasone and     flurbiprofen axetil may improve long-term survival. However, evidences from randomized     controlled trials are still lacking in this aspect.   "
8628|NCT03172975|"     This study evaluates the efficacy, safety and immunogenicity of different formulations of the     Na-GST-1 hookworm vaccine using a controlled human hookworm infection model in healthy,     hookworm-naive adults.   "
8629|NCT03172962|"     Low back pain (LBP) is common in the population and has great socioeconomic consequences for     societies across Europe and the United States. About a third of working-age adults have     frequent LBP, and for about 10% the pain becomes chronic with consequences for work and     leisure activities. A Cochrane review from April 2017 concluded that physical exercise is an     intervention with few adverse events and positive outcomes on pain and function in adults     with chronic pain. However, when scrutinizing the specific studies of the review there are     large differences in adherence to the exercise interventions and consequently in the results     obtained. Thus, there is a need for simple exercises that the patients can easily adhere to.   "
8630|NCT03172936|"     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics,     pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.   "
8631|NCT03172923|"     The investigators therefore propose to undertake a further randomised controlled trial     comparing the sliding hip screw (SHS) with the Targon PFT intramedullary nail. The aim is to     see if the summation of the first trial of 600 participants comparing the sliding hip screw     with the Targon PF nails, in conjunction with this study of 400 participants with the updated     Targon PFT nail produces results that convincingly demonstrate that this particular design of     implant is superior to the sliding hip screw. Because of the financial issues involved a cost     benefit comparison for the two procedures is planned at the completion of the study.      Primary outcome measures will be regain of walking ability. Secondary outcome measures     recorded with include mortality, length of surgery, operative blood loss, blood transfusion,     post-operative complications, hospital stay, need for subsequent revision surgery and degree     of residual pain.   "
8632|NCT03172910|"     This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and     safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban     measuring clotting times using Whole Blood Clotting Time (WBCT).   "
8633|NCT03172897|"     For patients undergoing mechanical ventilation, light sedation is better than deep sedation     for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of     mechanical ventilation, and decreased mortality. In a recent study of the investigators,     low-dose dexmedetomidine without sedative effects (0.1 ug/kg/h) improved sleep quality and     reduced the incidence of delirium in elderly patients admitted to the ICU after surgery. The     investigators hypothesize that, for ICU patients with prolonged mechanical ventilation,     low-dose dexmedetomidine infusion (0.1 ug/kg/h) may also be effective in decreasing delirium.     The purpose of this study is to investigate whether low-dose dexmedetomidine infusion can     reduce the incidence of delirium in ICU patients with prolonged duration of mechanical     ventilation (>= 24 hours).   "
8634|NCT03172884|"     To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic     or renal function in comparison to healthy subjects   "
8635|NCT03172871|"     This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy     and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with     schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment     phase with a 14(±2)-day safety follow-up.   "
8636|NCT03172858|"     This study is designed to determine if an intracervical balloon catheter (IBC) is better than     oxytocin for induction of labor in the setting of premature rupture of membranes (PROM) or     breaking the bag of water prior to onset of labor. The investigators suspect that an     intracervical balloon catheter will shorten the time interval from initiation of induction of     labor to delivery.   "
8639|NCT03172819|"     This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and     safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.   "
8640|NCT03172806|"     The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA,     STOP-Bang with former algorithm, and STOP-Bang with new algorithm).   "
8641|NCT03172793|"     Due to emerging resistance, new antibiotic options are needed to treat CF acute pulmonary     exacerbations caused by methicillin resistant Staphylococcus aureus (MRSA). There is     established evidence that adult patients with cystic fibrosis (CF) may have altered     antibiotic pharmacokinetics compared with non-CF patients. Telavancin is a lipoglycopeptide     antibiotic that has activity against gram-positive bacteria including MRSA. This study will     determine the pharmacokinetics and tolerability of telavancin in 18 adult CF patients     admitted for a pulmonary exacerbation at 1 of 4 participating hospitals in the US.   "
8642|NCT03172780|"     This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with     clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's     diclofenac gel in the symptomatic treatment of steoarthritis of knee compared to Voltaren®     gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.      Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of     the knee according to the American College of Rheumatology (ACR) criteria      Total study duration for the clinical part will be around 56 days that includes screening     period of 28 days and treatment period of 4 weeks.   "
8643|NCT03172767|"     The study aims investigate sensory processing disorders and school readiness in pre-school     preterm children and the relationship between sensory impairment and school readiness   "
8645|NCT03172741|"     Over the last two years, the United States has witnessed enormous change concerning the     acceptance of marijuana. The number of persons with MS (PwMS) using cannabis to treat their     symptoms is expected to rise, and it is important to provide clinicians and PwMS with     evidence based information on the safety and effectiveness of marijuana. In addition,     scientists need to identify the effects of medical marijuana as the compound action of     different cannabinoids, specifically tetrahydrocannabinol (THC) and cannabidiol (CBD). The     ratio of CBD to THC may have an important impact on the effects of the marijuana, which in     turn may have important implications for the medical benefits. The overarching goal of this     study is to advance a better understanding of the potential positive and negative effects     associated with different strains of marijuana, using an interventional design. The     investigators will examine three strains that differ markedly on THC potency (A. THC <1%, CBD     > 10%; B. THC >10%, CBD < 1%; C. THC 510%, CBD 510%) to determine whether the level of THC is     associated with differences in motor and cognitive functions in PwMS. One hundred PwMS will     be recruited for this project and followed for 3 months following designation to one of three     strains of marijuana with different ratios of CBD to THC or a placebo marijuana (THC 0%, CBD     0%). It is hypothesized that the strains with a high CBD to THC ratios will demonstrate the     most benefits on measures of motor and cognitive function.   "
8646|NCT03172728|"     The rationale for conducting the experiment including quantitative measures and a description     of the method of recruitment:      This study provides psycho-educational intervention aimed at raising awareness of post partum     Obsessive-Compulsive disorder (OCD) , reducing the intensity of symptoms and increase of self     referral to treatment. Various studies report that 1-11% of women after childbirth suffer     from OCD. A part of this population suffered from the disorder prior to giving birth and for     some this is a first outbreak. This is a psychological disorder characterized by obsessions     and compulsions. The disorder can appear or worsen at any time , and is characterized by     different content depending on the stage of life. Obsessional thoughts after birth often     includes harming the baby which alarms the woman and the surrounding, and affects her ability     to care for the baby and develop a beneficial relationship with him. Studies support a     bio-psycho-social model of OCD .and that adjustment period and physical changes after     childbirth can be create a psychological biological and environmental background, to the     development or worsening of OCD in women who suffer from or are prone to the disorder.      The present study deals with psycho-educational information which will be given to women     after birth who were identified as susceptible to develop OCD. The information will be     delivered in the maternity ward through written and recorded data , and sent through the     system Qualtrics 4 weeks after birth. Psycho-education is an important first step in     Cognitive Behavioral therapy for OCD and may lead to anxiety reduction and commitment to     treatment. The information sent in the study is similar to the information provided at the     beginning of standard Cognitive Behavioral Therapy.Women will be recruited from the maternity     ward at Lis Maternity Hospital. In order to identify women at risk for OCD, All women in the     maternity ward will be asked to fill a short questionnaire. Women found at risk or as     suffering from OCD will be invited to participate in the study.   "
8647|NCT03172715|"     The aim of this study is to compare knee function and pain one year after treatment of     intra-articular proximal tibia fracture using either osteosynthesis with a locking plate     (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.   "
8648|NCT03172702|"     The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be     dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month     long-term Maintenance Phase.   "
8649|NCT03172689|"     To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive     (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.   "
8650|NCT03172676|"     Thrombocytopenia refers to a reduction in platelet count to (<150 × 109/L). Immune     thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated     thrombocytopenia and the exclusion of other causes of thrombocytopenia   "
8651|NCT03172663|"     Obesity may directly or indirectly lead to hearing loss   "
8652|NCT03172650|"     Non-alcoholic fatty liver disease is the most common cause of chronic liver disease     worldwide. It is defined as the accumulation of fat (>5%) in the liver cells in the absence     of excessive alcohol intake or other causes of liver disease including viral, drug-induced,     or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic     syndrome.   "
8653|NCT03172637|"     A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including     decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual     abnormalities are common in CKD and many women are an-ovulatory .      Causes of sexual dysfunction in CKD include hormonal alterations along with vascular,     neurologic, psychogenic, and other factors, such as medications, contribute to the     development of sexual dysfunction . Sexual dysfunction in females is mainly due to hormonal     factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal     lubrication, and failure to conceive.   "
8654|NCT03172624|"     The purpose of this study is to find out what effects, good and/or bad, treatment with two     drugs called nivolumab and ipilimumab have on the participant and salivary cancer.   "
8655|NCT03172611|"     This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a)     and other atherogenic particles associated with cardiovascular disease risk.   "
8656|NCT03172598|"     A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in     Subjects with Painful Diabetic Peripheral Neuropathy   "
8657|NCT03172585|"     High resolution computed tomography of the chest is the gold standard imaging modality for     most pulmonary diseases. However, the associated high expenses, radiation exposure , and its     limited possibility for bedside use are a limitation.   "
8668|NCT03172442|"     This experimental study aims to evaluate the efficiency of the orthodontic removable traction     appliance in the treatment of skeletal class III malocclusion. The study sample will consist     of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly     into two groups: experimental group and control group. The dentoskeletal changes will be     assessed by using lateral cephalometric radiographs before treatment and after obtaining 3mm     positive overjet.   "
8669|NCT03172429|"     The purpose of the current study is to evaluate the cerebral tissue oxygenation of Kyrgyz     highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal     cohort study. To this end, the investigators will invite the same highlanders who     participated in the study in 2012 to undergo follow-up examinations in 2017, in order to     allow comparisons of current results with baseline data from 2012.   "
9136|NCT03166332|"     High risk women for growth restricted fetuses will randomized in the second trimester into     different strategies applied to the mothers: a stress reduction program based on mindfulness     techniques or a nutrition interventional program based on Mediterranean diet.   "
8658|NCT03172572|"     RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or     robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy     (OPD). The generalizability of the current literature is, however, unknown since randomized     studies are lacking, and current data are published from few, very high volume centers and     selection bias with a lack of case-matched series. International studies are lacking     completely.      OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in     high-volume European pancreas centers (>10 MIPDs per year, total >20 PDs per year).      METHODS: A retrospective multicenter propensity-score matched cohort study including all     consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and     December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic     pancreatitis. Predefined electronic case report forms will be disseminated amongst     participating centers. Participants are responsible for their own data collection. Matching     of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch     and German national registries) will be based on propensity scores determined by logistic     regression including preoperative variables: year of surgery, demographics, BMI, ASA,     comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary     outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day     postoperative events including: pancreatic fistula, length of hospital stay, R0     (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant     therapy and overall survival.   "
8659|NCT03172559|"     Liver transplantation (LT) represents the best treatment for patients with selected, early     stage hepatocellular carcinoma (HCC). Due to the gap between the number of patients on the     waiting list and the available donors, patients with HCC wait ~1 year to be transplanted.     While waiting, 25-30% of patients need to come off the transplant list due to tumor     progression beyond transplant criteria (extrahepatic disease, vascular invasion or increase     in tumor burden beyond enlistment criteria). To try to avoid this progression, patients are     treated while waiting with bridging therapies, mainly transarterial chemoembolization     (TACE) and ablation. Around 30% of patients are not eligible for these treatments (.e.g. due     to poor liver function). Stereotactic body radiotherapy (SBRT) has been shown to be an     effective treatment for advanced HCC in primarily small, single institutional studies and its     safety has been reported in cirrhotics. SBRT could be used in patients not eligible to TACE     or ablation as a bridge to LT reducing the risk of progression in the waiting list. This     study will evaluate if patients with liver cirrhosis and HCC benefit from receiving SBRT     while awaiting LT. Patients will be randomized to a treatment arm where they will receive     SBRT as a bridge therapy or to a no intervention arm. Outcomes prior and post to transplant     will be performed to evaluate the differences between both arms: proportion of patients that     do not drop-out of the list (are transplanted), liver decompensation while waiting,     perioperative measures in those that are transplanted, time to transplant or drop-out,     overall survival, disease-free survival in those that are transplanted in a population of     about 330 patients across all sites.   "
8660|NCT03172546|"     The primary objective of the present study is to determine the clinical, biological and     genetic determinants of the anticoagulant activity in patients treated with either anti-IIa     or anti Xa oral anticoagulants.      The secondary objective is to determine the clinical, biological or genetic determinants of     hemorrhagic or thrombotic complications during a one year follow-up.      Results will lead to a better prediction of both drug response and risk of complications.   "
8661|NCT03172533|"     The present study is a placebo-controlled randomised study on the effects of estrogen     replacement upon AN-associated psychopathology, several neurocognitive domains and     appetite-regulating circuits in female patients with AN.      The investigators aim at assessing peripheral concentrations of neuroendocrinological     components of the Hypothalamus-Pituitary-Gonadal (HPG) and Hypothalamus-Pituitary-Adrenal     (HPA) axis, as well as appetite-regulating hormones in AN and to examine associations with     AN-associated psychopathology and neurocognitive performances before (baseline), during and     after inpatient psychotherapy of female patients receiving concomitant treatment with     estrogens (vs. placebo).   "
8662|NCT03172520|"     The purpose of this study is to document the safety of the Medtronic automatic periodic     stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent     post-operative facial nerve weakness, which is a relatively common outcome after parotid     surgery.   "
8710|NCT03171896|"     The experience of labor for a woman can be rewarding but can be traumatic. Medical clowning     may alleviate the potential for trauma.   "
44818|NCT02699086|"     The purpose of this study is to evaluate the safety and efficacy in adult patients with     Attention-Deficit Hyperactivity Disorder (ADHD).   "
8663|NCT03172507|"     An observational pilot proof-of-principle study. 15 patients with significant coronary artery     disease and 15 matched controls. To investigate whether long-term activation of the innate     immune system, named 'trained innate immunity', occurs at the level of the bone marrow     progenitor cells in patients with significant coronary artery disease and whether this     correlates with the proinflammatory phenotype of monocytes.   "
8664|NCT03172494|"     This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin     degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes     mellitus inadequately controlled on oral antidiabetic agents   "
8665|NCT03172481|"     This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase     3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric     subjects between 6 to 12 years of age.   "
8666|NCT03172468|"     This study seeks to evaluate, whether patients suffering from cardiac arrest, that can be     successfully resuscitated, can be differentiated from those, that cannot be resuscitated,     using arterial blood pressure values.   "
8667|NCT03172455|"     An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic     stem cell transplantation.      This Program is available for female and male who are recipients of allogenic HSCT and who     have been newly diagnosed with acute GvHD.      Alpha 1 antitrypsin is being tested in a Phase 2/3 Clinical Study to evaluate the safety and     efficacy of Glassia (1-4) as an add-on bio pharmacotherapy to conventional steroid treatment     in subjects with acute graft versus host disease with lower gastrointestinal involvement     (NCT02956122).   "
8671|NCT03172403|"     Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a     master negative regulator of skeletal muscle mass. If the role of myostatin in cancer     cachexia is now well established in murine models, no study has focused on muscle expression     of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin     a biological marker of cachexia in patients with colon cancer. The main objective is to     compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of     cachexia in colon cancer patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be     determined in a muscle sample taken during the resection under general anaesthesia. Skeletal     muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength     of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6     months postoperatively. Blood sampling will also be performed on these 4 occasions.   "
8672|NCT03172390|"     Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture.     There is substantial variation in individual aneurysm progression: established risk factors     for an accelerated aneurysm growth rate include initial size or localization, the presence of     aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.   "
8673|NCT03172377|"     Crohn's disease is a chronic inflammatory bowel disease. This disease can be treated with,     among other things, biologicals such as adalimumab. Patients use adalimumab for a long time     to maintain remission and to prevent relapse of the bowel inflammation. The disadvantages of     this therapy are the high price and side effects (such as the higher risk of infection).      Currently, adalimumab is given every 2 weeks, by injection under the skin. The optimal time     between two injections has never been investigated before. Prior research in patients with     rheumatoid arthritis shows that disease remission can be maintained with longer     injection-intervals. Our hypothesis is that this is the same for Crohn's disease patients.     Our aim is to show non-inferiority of extending the adalimumab dosing interval, under strict     disease monitoring in Crohn's disease patients in sustained (>12 months) clinical remission,     compared to standard care.      During the trial,174 patients with stable Crohn's disease will be divided into 2 groups. One     group continues adalimumab injections with the same 2-week interval. And the other group will     incrementally extend the interval to 4 weeks, under strict disease monitoring. If a step-down     leads to recurrence of disease activity patients will return to the preceding effective     dosing interval. Thus, we will investigate whether, and for whom, it is safe to extend the     adalimumab injection interval.   "
8674|NCT03172364|"     The objective of this clinical study is to assess the cutaneous and ocular local tolerance of     two cosmetic facial cleansers in healthy female participants with sensitive skin under normal     conditions of use.   "
8675|NCT03172351|"     prospective, comparative (3 arms), randomized, multicentric clinical trial   "
8711|NCT03171883|"     The supraspinatus is a relatively small muscle of the upper back that runs from the     supraspinatus fossa superior portion of the scapula to the greater tubercle of the humerus.     It is one of the four rotator cuff muscles and also abducts the arm at the shoulder. A     supraspinatus tear is a tear or rupture of the tendon of the supraspinatus muscle.   "
8676|NCT03172338|"     The onset and course of heart failure (HF) is triggered by a complex regulatory network that     includes stressors (pressure overload by individual anatomic hemodynamic settings), intrinsic     (genes), environmental (regulating epigenetics), and modifying factors (such as hor-mones and     the immune system). SMART aims to establish individualized strategies for the prevention and     management of HF by early detection of the physiological, genomic, proteo-mic and hemodynamic     mechanisms that lead from onecommon cause of ventricular dysfunction (pressure overload) to     maladaptive remodelling and irreversible HF. To cope with the complexity of HF, SMART will     interrelate models describing the interplay between ge-nome, proteome and cell function,     regulating hormones, tissue composition and hemody-namic whole organ function up to a whole     body description of a patient and patient cohorts. The ultimate goal is to demonstrate     proof-of-concept tools for predicting disease evolution and efficacy of treatment in a given     patient. To achieve this task SMART will apply        -  A modelling framework that couples multi-scale mechanistic models with in-depth          genome/proteome, cell physiology and whole organ (biomechanical and fluid dynamic)          models        -  Subsequently, investigate methods validity and relevance for quantitative prediction          of treatment outcome in a clinical proof-of-concept trial (demonstrator) of patients          with aortic valve desieases.   "
8677|NCT03172325|"     The purpose of this study is to compare the efficacy and safety of adalimumab produced by     CinnaGen company and AbbVie adalimumab in subjects with active Rheumatoid Arthritis. Patients     with diagnosis of active Rheumatoid arthritis according to EULAR criteria (European League     Against Rheumatism) aged between 18 to 75 years are included. This is a Phase III,     randomized, two arms, double blind (patient and assessor blinded), parallel active non     inferiority controlled clinical trial. The eligible patients are randomized in a 1:1 ratio to     receive CinnoRA® or Humira®. Every 2 weeks, 40 mg of either of the drugs is administered to     each patient subcutaneously along with methotrexate (15 mg/week), folic acid (1 mg/day), and     prednisolone (7.5 mg/day) over a six-month period.      The primary objective of this study is to assess equivalence of test- adalimumab (CinnoRA®)     to the reference adalimumab (Humira®) in terms of efficacy in patients with moderate to     severe active rheumatoid arthritis.      The secondary objectives of this study are:        -  To further compare efficacy of test- adalimumab to reference adalimumab        -  To assess safety of test- adalimumab compared to reference adalimumab   "
8678|NCT03172312|"     Ready to establish the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy and     study the clinical value of Intraoperative Parathyroid Scores System for thyroidectomy.   "
8679|NCT03172299|"     The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its     goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation     of the eyeball is sometimes necessary after proton therapy in the case of neovascular     glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor)     and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to     necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The     intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular     glaucoma without avoiding enucleation in all cases. The investigators propose to study the     prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.   "
8680|NCT03172286|"     A study in the postpartum period reveals that among women who delivered vaginally and having     perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears     from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after     delivery.      Severe pain that is not taken into account can become chronic pain. It has physical and     psychological consequences. It is therefore essential to prevent these risks in young     mothers.      The main objective of this study is to assess the efficacy of radiofrequency treatment on     perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with     perineal lesions.      A double-blind randomized prospective single-center study will be conducted on patients     delivering at Marseille's north hospital.      Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy)     will be invited to enroll in the study.      Patients will be then randomized into two groups, one with radiofrequency treatment, the     other without treatment with radiofrequency.      The duration of inclusion is provided over 6 months. Each topic will be followed over a     period of 1 month. The total study duration is 7 months.      The expected results are a significant reduction in pain scores during the first days     postpartum in women with perineal alteration caused by a vaginal delivery instrumented or     not. Also an improvement in the quality of life of patients during the first days.   "
8681|NCT03172273|"     This multicenter RCT is designed to investigate if TIPS with covered stents improves     transplant-free survival for cirrhotic patients with early stage of refractory ascites     compared to LVP+albumin during 1 year follow-up period.   "
8682|NCT03172260|"     This is an observational study, to test the hypothesis that E Balance Pro Therapy     micro-current treatments, delivered with precision in amplitude, waveform and pulsing     pattern, adapted by other aspects of this device's technology could affect ion flow across     cells and tissues in a fashion that modifies or transforms a crucial pathophysiologic deficit     present in patients with diabetes. E Balance Pro Therapy can supplement standard treatment,     as an adjunct, and help patients better manage their diabetes. HbA1C is the primary endpoint     of this study. However, we expect to see changes in other symptoms (if present) associated     with diabetes such as: blood pressure, insulin sensitivity, neuropathic pain retinopathy and     wound healing.   "
8683|NCT03172247|"     Care of the diabetes is multidisciplinary with the involvment either private and hospital     specialist   "
8684|NCT03172234|"     To evaluate the effect of oral amantadine versus gabapentin premedication on the hemodynamic     response to laryngoscopy and tracheal intubation and their effect on β-endorphins.   "
8685|NCT03172221|"     This is a cross-sectional and multicentre clinical trial to study the performance of the     Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the     detection of malaria during pregnancy in low transmission settings from Colombia and     Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy,     and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral     blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.   "
8687|NCT03172195|"     Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that     requires the use of immunosuppressive therapies. In previous studies, the active role of     cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus     DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive     lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of     this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase     Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex)     together with that of CMV in colonic mucosa depending of the local inflammation     (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to     severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral     load will also be correlated to the Mayo endoscopic score and the response to     immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).   "
8688|NCT03172182|"     Preoperative anxiety is associated with adverse consequences such as emergence delirium, and     postoperative behavioral changes. According to previous studies, providing information of     anesthetic procedures helps to lessen preoperative anxiety. However, verbal explanation alone     provides the limited effect, and the tour program of the operating room prior to surgery may     not be possible for a number of hospitals due to organizational and financial reasons.     Therefore, the virtual reality (VR) tour of the operating room may be an innovative and novel     method to give children information about the preoperative process and to alleviate the     preoperative anxiety. In this study, we intend to evaluate the effects of the operating room     virtual tour on preoperative anxiety as well as emergence delirium and postoperative     behavioral changes, in pediatric patients.   "
8689|NCT03172169|"     Through the literature screening of MyomiRX 7, the detection of mechanical ventilation group,     difficult withdrawal unit and healthy adult plasma levels of MyomiRX in the evaluation of     function and skeletal muscle thickness of the diaphragm, the correlation analysis of 7 kinds     of MyomiRX and diaphragmatic dysfunction. The research value of this project is to explore     the predictive value of plasma MyomiRX level on diaphragmatic dysfunction in patients with     mechanical ventilation, and to lay the foundation for finding the target of VIDD diagnosis     and treatment   "
8690|NCT03172156|"     CtDNA detection is a noninvasive detection method, and the second generation of     high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can     detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA     dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive     effect of ctDNA .   "
8691|NCT03172143|"     The purpose of this study is to determine if taking an increased sampling of mesentery (fatty     tissue next to the intestine) and lymph nodes at the time of the subject's ileocolic     resection prevents a 4-6 month recurrence of Crohn's disease at the site of the new     connection.   "
8754|NCT03171324|"     Term infants (Small for Gestational Age and Appropriate for Gestational Age) would be     randomized to receive oral iron supplementation from 6 weeks and 6 months. Growth in terms of     Occipitofrontal circumference, length and weight would be monitored at 6 weeks, 6 months and     1 year of age. Hemoglobin, RBC (Red blood corpuscles) indices and ferritin would be monitored     at 6 months and 1 year of age.   "
8692|NCT03172130|"     Chronic cough is an important clinical problem in primary care and sub-specialty practice.     Besides the distress experienced by patients with chronic cough, significant healthcare     resources are expended to understand the role of gastroesophageal reflux, asthma and     post-nasal drip in understanding their contribution to cough.      Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly,     treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in     cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough     includes beneficial effects on reflux and airway inflammation.      The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in     chronic cough patients improves cough. While these patients with chronic cough are not     routinely screened and treated for OSA, this study aims to evaluate these chronic cough     patients with screening questionnaires for OSA and if necessary with polysomnography and     randomize them to either CPAP or sham CPAP for 6 weeks.   "
8693|NCT03172117|"     A long-term follow-up study to obtain safety and efficacy data in subjects who completed     phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups     for up to 36 months after the initial administration in patients suffering from Alzheimer's     disease   "
8694|NCT03172104|"     Research question: The primary aim of this study is to compare the prevalence of motor     impairment from birth to five years of age between children born <30 weeks and term-born     controls, and to determine whether persistent abnormal motor assessments in the newborn     period in those born <30 weeks predict abnormal motor functioning at age five years.     Secondary aims for both children born<30 weeks and term children are i) to determine whether     novel early magnetic resonance imaging (MRI) - based structural or functional biomarkers are     detectable in the neonatal period that can predict motor impairments at five years, ii) to     investigate the association between motor impairments and concurrent deficits in body     structure and function at five years of age, and iii) to explore how motor impairments at     five years, including abnormalities of gait, postural control and strength, are associated     with concurrent functional outcomes including physical activity, cognitive and learning     ability, behavioural and emotional problems.      Design: Prospective longitudinal cohort study. Participants and Setting: 150 preterm children     (born <30 weeks) and 151 term-born children (born >36 completed weeks' gestation and     weighing>2499 g) admitted to the Royal Women's Hospital, Melbourne, were recruited at birth     and will be invited to participate in a five-year follow-up study.      Procedure: This study will examine previously collected data (from birth to two years) that     comprises the following: detailed motor assessments and structural and functional brain MRI     images. At five years, preterm and term children will be examined using comprehensive motor     assessments including the Movement Assessment Battery for Children - 2nd edition and measures     of gait function through spatiotemporal (assessed with the GAITRite® Walkway), dynamic     postural control (assessed with Microsoft Kinect) variables and hand grip strength (assessed     with a dynamometer); and measures of physical activity (assessed using accelerometry),     cognitive development (assessed with Wechsler Preschool and Primary Scale of Intelligence)     and emotional and behavioural status (assessed with the Strengths and Difficulties     Questionnaire and the Developmental and Wellbeing Assessment). Caregivers will be asked to     complete questionnaires on demographics, physical activity, activities of daily living and     motor function (assessed with Pediatric Evaluation of Disability Inventory, Pediatric Quality     of Life Questionnaire, the Little Developmental Co-ordination Questionnaire and an activity     diary) at the 5 year assessment.      Analysis: For the primary aim the prevalence of motor impairment from birth to 5 years will     be compared between children born <30 weeks and term-born peers using the proportion of     children classified as abnormal at each of the time points (term age, one, two and five     years). Persistent motor impairments during the neonatal period will be assessed as a     predictor of severity of motor impairment at 5 years of age in children born <30 weeks using     linear regression. Models will be fitted using generalised estimating equations with results     reported using robust standard errors, to allow for the clustering of multiple births.      Discussion/Significance: Understanding the developmental precursors of motor impairment in     children born <30 weeks is essential to limit disruption to skill development, and potential     secondary impacts on physical activity, participation, academic achievement, self-esteem and     associated outcomes, such as obesity, poor physical fitness and social isolation. Better     understanding of motor skill development will enable targeting of intervention and     streamlining of services to the individuals who are at highest risk of motor impairments.   "
8695|NCT03172091|"     The aim of research is to identify markers of acute rejection by VOC analysis in exhaled     breath of bilateral-lung transplanted patients. 120 bi-lung transplanted patients will be     divided into two groups : patients with acute rejection diagnosed on transbronchial biopsies     and patients with no acute rejection. Exhaled breath will be collected for VOC analysis woth     electronic nose and mass spectrometry. VOC profiles will be compared between the two groups     of patients.   "
8696|NCT03172078|"     To compare the total amount of propofol used by the manually-control infusion (MCI) and     Target-control infusion (TCI) using standard monitoring without BIS or standard monitoring     with BIS during advanced endoscopic procedure.   "
8697|NCT03172065|"     Conventionally General anaesthesia remains the choice for the majority of open abdominal     surgical procedures, and regional anaesthesia is preferred only for patients who are at high     risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the     first choice for laparoscopic cases was its advantages over general anaesthesia which include     uniform total muscle relaxation, a conscious patient, economical, relatively uneventful     recovery, pain free early postoperative period and the protection from potential     complications of general anaesthesia. The main debatable point, however, seems to be the     status of respiratory parameters among the two modes of anaesthesia during laparoscopic     surgery. In this context it can be stated that spontaneous physiological respiration during     spinal anaesthesia would always be better than an assisted respiration as in general     anaesthesia.      The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the     diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered   "
8699|NCT03172039|"     This quality improvement study will assess the antimicrobial use and prescribing practices of     hospital and community prescribers for the ambulatory hemodialysis (HD) population in an     urban academic outpatient HD unit in Ontario. Currently, in the outpatient HD unit at Toronto     General Hospital (TGH), it is the standard of care for the patients to be screened on a     weekly basis by the nephrology care team for the use of any oral or intravenous     antimicrobials. Patient charts, pharmacy patient profiles and electronic medical records for     these patients from September 1 2016 - April 30 2017 will be retrospectively reviewed in     order to characterize antimicrobial use and its concordance with available clinical     guidelines and antimicrobial stewardship principles described by the Centers for Disease     Control and Prevention (CDC). The primary objective of the study is to determine the     prevalence of antimicrobial use in an ambulatory HD population. The secondary objective of     the study is to determine the congruence of prescribed antimicrobial regimens with available     clinical guidelines and antimicrobial stewardship principles described by the CDC. It is     hypothesized that antimicrobial use among HD patients will be common and that antimicrobial     prescribing practices are not congruent with recommendations from published clinical     guidelines and antimicrobial stewardship principles for a significant proportion of patients     included in the retrospective review. Descriptive analysis of the data will summarize the     findings. Future research will build upon the results of this project, and may include the     development of interventions that target gaps in knowledge and prescribing behaviours of     prescribers who provide care to the ambulatory HD population.   "
8700|NCT03172026|"     After stroke, the combination of progressive skills practice in an adequate dose, exercise     for fitness, and reduced sedentary time will augment motor and cognitive outcomes.     Sensorimotor and cognitive improvements after stroke often reach a general plateau by     approximately 12 weeks after onset, however. Drugs that might enhance learning or neural     repair, as well as other molecular and synaptic adaptations that occur during skills training     and fitness exercise, might extend that recovery curve, although to date only fluoxetine has     given any hint of this. Most trials have tested agents that modulate neurotransmitters.     Several very recent preclinical experiments and observational studies in patients after     stroke suggest that the commercially available medication, Maraviroc, a CCR5 antagonist, may     augment skills learning during rehabilitation training, especially during the first three     months after onset, by affecting CREB and synaptic plasticity.      The investigators will carry out a randomized controlled trial of Maraviroc in patients with     disabilities severe enough to have required inpatient stroke rehabilitation and, based on our     preclinical data, who can start the drug intervention within 6 weeks of stroke onset. The     investigators will compare usual post-stroke care plus placebo versus Maraviroc given for 8     weeks in 60 participants. However, to try to maximize the amount of practice that is most     relevant to the primary outcome measurements and determine whether or not Maraviroc can     enhance the effects of training, as hypothesized, all participants will be tele-monitored by     mobile health devices and will receive weekly telephonic encouragement, based on device data,     to walk, reduce sedentary time, and reach and grasp in the home in between usual care     therapies. Compliance, serial motor changes over time, and self-management skills in making     use of the telerehabilitation devices will be a nested substudy of feasibility of remote     monitoring and feedback.   "
8701|NCT03172013|"     Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients   "
8702|NCT03172000|"     Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in     humans.   "
8775|NCT03171051|"     This study is being conducted to evaluate the ability of a light emitting diode (LED) study     device's ability to raise the temperatures on flank tissue to a similar level compared to an     approved laser device (SculpSure by Cynosure). Laser treatments have been shown to reduce fat     in the flanks by heating the fat cells and causing them to burst. The contents of the cells     are then cleared naturally by the body.   "
8703|NCT03171987|"     This is a prospective, randomized, single blinded, two-arm, head to head study.      The purpose of this study is:        -  To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for          treatment of acute low back pain.      Determining the effect of the 5% lidocaine patch and flurbiprofen patch for improving     functional disabilities and in reducing pain resulting from acute low back pain. Efficacy     will be determined by the level of pain relief (as measured by the Numerical Rating Scale,     NRS), decrease in analgesics, improved quality of life (as measured by the Oswestry     Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain     interference with function (as measured by the Brief Pain Inventory-Interference scale,     BPI-QoL), Short-Form McGill Pain Questionnaire-2(SF-MPQ-2), general health status (as     measured by the EQ5D), Overall treatment effect (OTE), physical exam from baseline up to     1-Months.   "
8704|NCT03171974|"     Ultrasound guided treatment of steroids for capsular contracture in patients with     reconstructed/augmented breast   "
8705|NCT03171961|"     Online visit and online counseling via telemedicine technology is a new service for obese     people who wish to lose weight but because of their active lifestyle and time limitation     cannot come to clinic. The purpose of this study was to examine the efficacy this     technology-based intervention on weight loss in obese and overweight female adults.   "
8706|NCT03171948|"     The purpose of this study is to assess the effects of limited portion of almond consumption     after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight     maintenance in obese female adults.   "
8707|NCT03171935|"     The main purpose of the present study is to verify whether, as compared with conventional     weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive     pressure ventilation may more effective in shortening the duration of invasive ventilation,     hence reducing the rates of complications and mortality in patients with acute hypoxemic     respiratory failure.   "
8708|NCT03171922|"     The purpose of this study is to examine the efficacy of an internet based diet plus a regular     dedicated dietary coach (ID group) versus clinic visit based weight loss program (CD group)     on weight loss in obese and overweight female adults.   "
8709|NCT03171909|"     About one third of twin pregnancies are resulting from a single fertilized oocyte. Two third     of these monozygotic twins share a common placenta and are therefore called monochorionic.     Due to placental sharing and the ever-present inter-fetal vascular connections, specific     complications may arise and lead to an increased risk of intrauterine death and long-term     neurodevelopmental impairment. Specific complications include twin-to-twin transfusion     syndrome (TTTS), twin-anemia-polycythemia sequence (TAPS), selective intrauterine growth     restriction (sIUGR) and discordant major anomalies, occurring in about 10%, 5%, 20% and 6% of     monochorionic diamniotic twins. Prenatal interventions may improve perinatal and long-term     outcome of affected fetuses. However, general knowledge about early diagnosis of     monochorionic twins and their specific complications is still limited in a significant number     of practitioners in Austria and systematic analysis of pregnancy outcomes are not conducted.      In this prospective multicenter registry study, the investigators aim to include all     monochorionic pregnancies in Austria. Main outcome parameter is the occurrence of     complications. Secondary outcomes are gestational age at occurrence of complications,     gestational age delivery and neonatal outcome. The investigators also strive for long-term     outcome, especially of infants following complicated pregnancies or preterm birth.   "
8712|NCT03171870|"     Idiopathic pulmonary fibrosis is defined as a specific form of chronic, progressive fibrosing     interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the     lungs, and associated with the histopathologic and/or radiologic pattern of usual     interstitial pneumonia.      The definition of Idiopathic pulmonary fibrosis requires the exclusion of other forms of     interstitial pneumonia including other idiopathic interstitial pneumonias and Interstitial     lung disease associated with environmental exposure, medication, or systemic disease.      Prevalence estimates for Idiopathic pulmonary fibrosis have varied from 2 to 29 cases per     100,000 in the general population IPF should be considered in all adult patients with     unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar     inspiratory crackles, and finger clubbing.   "
8713|NCT03171857|"     A wide variety of superficial soft tissue masses may be seen in clinical practice.     Superficial soft tissue masses can generally be categorized as mesenchymal tumors, skin     appendage lesions, metastatic tumors, other tumors and tumor-like lesions, or inflammatory     lesions. The investigators will use doppler ultrasound in evaluation of superficial soft     tissue masses characterization.   "
8714|NCT03171844|"     In the reanimation neonatal department of the Nice's hospital, 34% of newborns admitted have     an umbilical vein catheter (KTVO). Their parents are admitted 24h/24h by their side, where     everything is done to set up the Attachment (participation in care, skin to skin, support of     breastfeeding, ...).      The benefits of skin to skin described in developmental care of the newborn in the neonatal     health services are well established. Nevertheless, for supposed risks (infectious and     displacement of the catheter), registered in the memory of the teams, this care is not     currently carried out when the newborns are carrying an umbilical venous catheter.      Sometimes, because of the presence of an umbilical venous catheter, parents and their     newborns could not enjoy this moment of well-being in the first days of life. We therefore     propose a study evaluating the current risks of skin to skin with an umbilical venous     catheter by reflecting on a new protocol for laying and fixing this medical device.   "
8715|NCT03171831|"     The purpose of the study is to assess the safety and efficacy of haploidentical hematopoietic     stem cell transplantation for patients with thalassemia major.   "
8717|NCT03171805|"     Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to     manage gastric varices. However, more than one third of patients after BRTO treatment     experienced worsening of esophageal varices. The present study was designed to evaluate the     effect of post-BRTO propranolol adminstration on the change of esophageal varices.   "
8776|NCT03171038|"     TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the     long-term impact of a 6-months telemonitoring program in chronic heart failure patients.   "
8777|NCT03171025|"     This is a phase 2, single arm, open label trial to evaluate the rate of failure free survival     at 2 years after start of study treatment with adjuvant nivolumab in adult subjects who     undergo chemoradiation for localized bladder cancer.   "
8718|NCT03171792|"     The purpose of this study is to explore the perspectives of health professionals on chronic     (non-malignant) musculoskeletal pain in adolescence and young adulthood. The prevalence of     this pain symptom is rising for ten years, and most of the time the diagnosis is complex.     Health professionals have to differentiate between the continuing activity of a somatic     problem, some painful sequelae, a low threshold for the perception of pain, and psychological     symptoms with somatic expression. Diagnosis in this case takes time, and is a matter of     trained specialists. No protocol exists to assess the sub-clinical symptoms which will be     used to help doing this complex task.      This qualitative study will elicit the perspectives of trained specialists on this diagnosis:     how do they deal with these patients? What signs and symptoms helps them? The results will     present their clinical experiences. The overall goal is to construct the first chronic     musculoskeletal pain multidimensional scale that will help the practitioners with this     complex diagnosis.   "
8719|NCT03171779|"     More than 300,000 people die each year in France from a disease that may require palliative     care. Nevertheless, only a small proportion of these patients are able to access this care,     in particular because of a too late identification.      While several factors may hinder access to specialized palliative care resources, one of the     major barriers to the initiation of palliative care, and particularly to the implementation     of quality end-of-life care, Remains the failure to recognize that patients with advanced     chronic illness are actually approaching the end of their lives.      However, it is now clearly established that early integration of palliative care in the care     of people living with a serious, incurable and progressive disease:        -  has an impact on the quality (and sometimes the expectation) of life of these people,        -  avoids aggressive treatments and unplanned hospitalizations,        -  is associated with lower health costs than other end-of-life patients. Primary health          care providers have a major role to play in facilitating access to palliative care, but          their practice has been hampered in our country by the fragmented and poorly coordinated          nature of primary care and Negligible in terms of training. However, they remain the          first contact of the patients with the system of care, and are also structuring for the          continuation of the patient's journey within the health system.      The first hypothesis is that the work of genuine interprofessional primary care teams in     multi-professional health centers (MSPs), coupled with adequate training in the use of simple     tools, can contribute to the early identification of patients approaching End of life, to     meet their palliative care needs.      However, various European programs (Gold Standards Framework in the UK, NECPAL in Catalonia,     RADPAC in the Netherlands) have shown that identification alone is not enough to increase     access to specialized palliative care. The second hypothesis is that it must be articulated     for this with a training of the professionals to carry out conversations of anticipated     planning of the care with their patients.   "
8720|NCT03171766|"     The main goal of the investigation is to identify the incidence of cognitive dysfunction and     POD in patients older than 65 years of age undergoing neurosurgical elective surgery and     determine if an association between cognitive dysfunction, basal NIRS and POD exists.   "
8721|NCT03171753|"     Music can reduce anxiety in adult patients awaiting surgical interventions. The study was     designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory     enzymes, skin resitance between surgical patients listening music vs no sound.   "
8722|NCT03171740|"     Study where children will receive one premedication, either intranasal dexmedetomidine or     oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that     dexmedetomidine is superior but previous studies lack quality.   "
8916|NCT03169205|"     The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting     or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal &     fetal complications and to predict the risk factors for poor maternal, fetal & neonatal     outcomes   "
8723|NCT03171727|"     Transjugular intrahepatic portosystemic shunt (TIPS) dysfunction is defined as a loss of     decompression of the portal venous system due to occlusion or stenosis of the TIPS. Occlusion     of the TIPS can either be due to thrombosis or hyperplasia of the intima. Thrombosis of the     TIPS usually occurs early and can happen within 24 hours of TIPS creation. The frequency of     this complication is on the order of 10%-15% when bare stents are used. Post-TIPS short-term     low molecular weight heparin (LMWH) was used to prevent the early thrombosis formation.     Weather post-TIPS LMWH was necessary when polytetrafluoroethylene-covered stent was used     during TIPS creation was not answered. The present study was designed to evaluate the effect     of short-term use of LMWH on early TIPS dysfunction.   "
8724|NCT03171714|"     In this research study, a device called the Derma-Stent will be tested. The sponsor of the     study, Mar-Med Company, will supply the device. This device is used to drain a cutaneous     abscess, which is a skin infection that results in buildup of pus under the skin. Currently,     the normal treatment for this abscess is to cut and drain and the wound, and later pack the     wound with gauze. Packing is done to prevent the pus to accumulate again. But regular gauze     is difficult for patient to remove themselves, so another visit to the doctor is usually     necessary. The Derma-Stent device will be tested to see how easily patients can remove this     by themselves and if it is less painful and more effective than normal gauze packing.   "
8725|NCT03171701|"     The transplant is the definitive treatment of renal insufficiency, in our days. While waiting     for it, the arteriovenous fistula surgery is standard procedure.   "
8726|NCT03171688|"     Investigators will observe the incidence of post-cesarean nausea or vomiting and try to     associate it with some risk factors.   "
8727|NCT03171675|"     This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid     and placental tissue samples of pregnant females as a possible marker in determining whether     or not an association exists between chronic periodontitis and preterm labor. Interleukin-17     is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal     disease.   "
8728|NCT03171662|"     Appendicitis is the most common abdominal disease requiring surgery in children. The risk of     developing appendicitis during a lifetime is reported to be 8.7% for boys and 6.7% for girls.     Despite its high incidence, there are still diagnostic difficulties. The overall negative     appendectomy rate among all children is suggested to be 8.4%, but in children under 6 years     of age, the rate has been reported to be as high as 56.7% . The diagnosis of acute     appendicitis is considered to be especially challenging in children due to difficulties in     communication and examination.   "
8756|NCT03171298|"     Rectal cancer is one of the frequent malignant neoplasms ,Total mesorectal excision (TME) has     become the gold standard treatment for middle and lower rectal cancers. Laparoscopic TME     still be difficult in patients with low rectal tumors, narrow pelvic anatomy, male sex or     high body mass index . Difficult visualization of the pelvic anatomy along with the     limitation of rigid laparoscopic instruments may affect the quality of oncological outcomes     and increase the risks of injuries during surgery. A down to up approach via transanal total     mesorectal excision (TaTME) technique may overcome these problems   "
8729|NCT03171649|"     Stroke is the third most common cause of death and the main cause of acquired adult     disability in high-income countries. The most common deficit after stroke is motor impairment     of the contralateral arm, with more than 80% of stroke survivors experiencing this condition     in the acute phase, and only half regaining some useful upper limb function after six months.      Within the European project RETRAINER (grant agreement No 644721), the consortium developed a     platform for the rehabilitation of the upper limb after stroke, which combines a passive arm     exoskeleton for weight relief supporting both shoulder and elbow movements, Functional     Electrical Stimulation (FES) of the two-most impaired muscles of the affected side,     interactive objects, and voluntary effort. The system also provides a graphical user     interface which helps the therapist set the training session and save the training data and     parameters, and provides the subject a visual feedback about his/her active involvement in     the exercise. The training consists of the execution of a series of exercises involving the     affected arm during daily life activities. Typical exercises are anterior reaching on a plane     or in the space, moving an object on a plane or in the space, moving the hand to the mouth,     with or without an object in the hand, and lateral elevation of the shoulder.      The aim of this clinical study it to evaluate the efficacy of this novel training platform on     patients between two weeks and nine months after their first stroke, who preserved at least a     visible muscle contraction for the arm and shoulder muscles. Participants are randomized in     an experimental and a control group. The control group is trained with an advanced     rehabilitative program, including physical training, occupational therapy, FES, and virtual     reality, while the experimental group is trained with the RETRAINER system for about 30     minutes, in addition to the same program of the control group. The daily training time is the     same for the two groups. The intervention consists of three sessions a week for nine weeks.     Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week     follow-up visits. It is planned to recruit 68 subjects for this study.      Since the RETRAINER platform was built on the up-to-date theory of motor re-learning, which     supports task-oriented repetitive training, a close temporal association between motor     intention and stimulated motor response, and an intensive and frequent training paradigm, the     study's hypothesis is that the experimental group shows a greater treatment effect than the     control group.   "
8730|NCT03171636|"     The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients,     as well as clinical-prognostic correlation, are crucial in the era of targeted therapies.     EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in     non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future     for newest target drugs. In Brazil, we have few data about the prevalence of EGFR and KRAS     mutations and their knowledge would allow us to optimize personalized medicine.   "
8731|NCT03171623|"     This is a phase 1 radomized,double-blind,placebo-controlled study with single oral dose of     globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated     the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin     hydrochloride (SY-004).   "
8732|NCT03171610|"     The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in     patients undergoing laparoscopic nephrectomy   "
8733|NCT03171597|"     This study evaluates the clinical efficacy of the famous prescription in the treatment of     unstable angina pectoris. All of the patients will be divided into 4 arms according to their     syndrome type. One of the arms will be treated by conventional western medicine, the other     three will be treated by different Chinese herbal medicine prescription at the base of     conventional western medicine.   "
8734|NCT03171584|"     Onychomycosis refers to the fungal infection of the fingernails or toenails, caused by     dermatophytes, yeast and non-dermatophyte molds that lead to distortion, discoloration,     thickening and detachment from the nail bed   "
8735|NCT03171571|"     Unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge     financial burden in EU healthcare systems. Unfortunately, the communication of Public Health     failed to influence consumer to change their habits. In this study, the aim is to evaluate     the impact of a regular monitoring during 1 year on wellbeing and dietary habits in healthy     volunteers.   "
8749|NCT03171389|"     This is a non-randomized, open-label, multicenter phase 2 study to evaluate the efficacy and     safety of ponatinib in patients with metastatic and/or unresectable GIST after prior failure     or intolerability of imatinib. Patients will be enrolled into 1 of 2 cohorts based on absence     (Cohort A) or presence (Cohort B) of KIT exon 13 resistance mutations as measured by liquid     biopsy. A third cohort (Cohort C) will include patients who have received all approved lines     of TKI treatments (imatinib, sunitinib and regorafenib).   "
8736|NCT03171558|"     This study will compare the gastric pull up (GPU) with the free flap [(specifically,     anterolateral thigh (ALT) and radial forearm free flap (RFFF)] techniques used in the     reconstruction of alimentary tracts in patients who require laryngectomy and circumferential     pharyngectomy for carcinoma resection. These two interventions will be compared by block     randomizing 20 patients based on history of failed chemoradiation to undergo either ALT or     RFFF. The primary outcome will be the type and number of postoperative complications. The     secondary outcomes will include swallowing function, speech, and quality of life measures     along with cancer specific endpoints.   "
8737|NCT03171545|"     The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure     during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment     will take place on the clinic level rather than the patient level.   "
8738|NCT03171532|"     This study aims to study differences in clinical and functional outcomes at 2 years based on     hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or     5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in     our subset of patients in Asian population context.   "
8739|NCT03171519|"     Introduction: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating     and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or     difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at     least 3 months. Pharmacologic therapy is the most commonly method used for its treatment,     however, pharmacotherapy is associated with side effects. Thus, non-pharmacological therapies     have been suggested as an alternative. Objective: To verify the effects of exercise     associated with acupuncture on chronic insomnia. METHODS: 40 patients with chronic insomnia     will be randomly assigned into two groups: CONTROL (n = 20) and ACUPUNCTURE (n = 20). The     volunteers of the CONTROL group will be submitted to 12 weeks of aerobic exercise, performed     on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day.     ACUPUNCTURE volunteers will perform aerobic exercise, following the protocol of the CONTROL     group, plus acupuncture therapy once a week. The sleep evaluation will be evaluated by     polysomnography and questionnaires. Expected Results: A 12-week combined therapy could     potentiate the previously described positive effects of exercise in the treatment of chronic     insomnia.   "
9150|NCT03166150|"     The purpose of this study is to improve urinary incontinence in older women by building     strength in the pelvic and lower body muscle through exercise and rehabilitation. The study     will also look at quality of pelvic floor and lower extremities muscles using MRI (Magnetic     Resonance Imaging).   "
8740|NCT03171506|"     The objective of this investigation is to examine the effects of 12 weeks of usual care plus     a ketogenic diet (KD) or usual care plus dietary recommendations endorsed by the Academy of     Nutrition and Dietetics (AND) in women with ovarian and endometrial cancer. Participants     undergo testing at baseline and at 12 weeks; the testing consists of blood draws,     questionnaires, and measures of body composition. The baseline visit also includes a meeting     with a registered dietitian to discuss the guidelines of the assigned diet.      It is hypothesized that the KD group will have improved cancer outcome measures, beneficial     body composition changes, reduced fasting concentrations of glucose and insulin, and higher     ratings of patient satisfaction with the diet relative to the AND group.   "
8741|NCT03171493|"     This is a Phase 1 study designed to test the tolerability and feasibility of intravesical     therapy with an attenuated Measles virus (MV-NIS) in patients with urothelial carcinoma who     are undergoing radical cystectomy but are ineligible or do not desire neoadjuvant     chemotherapy.   "
8742|NCT03171480|"     A randomized controlled trial (RCT) of nitric-oxide donor (NOD) isosorbide mononitrate (IMN)     versus placebo as an adjuvant to misoprostol/ intra-cervical Foley bulb for induction of     labor to decrease rate of cesarean deliveries in pregnancies complicated by preeclampsia     (≥24/0 weeks' gestation)   "
8743|NCT03171467|"     Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental     salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of     serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic     salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).   "
8744|NCT03171454|"     In this prospective, randomized, controlled study, the investigators wish to compare the     efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of     adhesion reformation after hysteroscopic adhesiolysis.   "
8745|NCT03171441|"     This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal     children according to adiposity status.   "
8746|NCT03171428|"     The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA)     versus the abdominal approach (AA) is still debated.      The aim of the study is the analysis of the perioperative outcome of patients operated with     or without the TAA for liver tumors.   "
8747|NCT03171415|"     Obesity is a direct result of food-intake in excess of body energy expenditure. Thus,     induction of increased energy expenditure via the activation of thermogenesis at targeted     anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel     compound, in treating obesity by activating thermogenesis in subcutaneous fat.   "
8748|NCT03171402|"     The investigators are conducting a study to better understand how the average consumer     differentiates between bitter and astringent sensations, both of which are typically     unpleasant sensations characteristic of some healthy foods. Astringency is the dry/rough     sensation elicited by foods such as green bananas and some wines. Although trained scientists     can differentiate between these stimuli, untrained participants rate them similarly, despite     their differences. This confusion has created additional barriers in understanding the     mechanism of astringent perception, which is currently debated. Understanding how to design     experiments where untrained participants can clearly evaluate both sensations will lay the     foundation to better understand astringency.      One mechanism that is believed to contribute to astringency is the interaction of astringent     stimuli with salivary proteins. Interestingly, the salivary protein profile may be influenced     by consumption of fruits and vegetables. Therefore, the investigators will evaluate how     bitter and astringent perceptions differ among high and low consumers of fruits and     vegetables by collecting saliva following exposure to the stimuli. This knowledge will inform     approaches to increase the appeal of healthy food.   "
8804|NCT03170674|"     The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to     tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of     the three electronic cigarettes or abstinence.   "
8750|NCT03171376|"     Increased incidence of apical periodontitis was reported where root filling was found coronal     to the marginal bone due to communication between pulp and periodontal space. It has been     suggested to place intraorifice barrier in the canal to provide coronal seal. However there     exists a void in literature regarding clinical validity of the termination of obturation     apical to marginal bone and placement of intraorifice barrier in resolution of periapical     pathology. Therefore this randomized controlled trial intends to investigate effect of     coronal level of obturation on endodontic success and marginal breakdown.   "
8751|NCT03171363|"     The purpose of this study is to determine whether giving gaze-contingent feedback is an     effective attention modification procedure, helping in the treatment of anxiety disorders in     children.   "
8752|NCT03171350|"     Participants who meet the eligibility criteria and who consent to participation or whose     parents/legal guardian consent to their participation, will be enrolled in the study for a     period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will     include the collection of throat swabs, testing by staff at the site using the ellume·lab     Group A Strep Test and testing for Group A Streptococcus by a central laboratory using     bacterial culture and polymerase chain reaction (PCR). All participants will be followed up     with a phone assessment of adverse events between Days 2-14.   "
8753|NCT03171337|"     Epidemiological studies show a one-year prevalence of 30%-60% for episodic tension-type     headache (TTH) and 2%-3% for chronic TTH (CTTH). Many TTH patients seek acupuncture treatment     worldwide, and CTTH is one of the most commonly treated. FSN has been used to treat CTTH     recently; the curative effect of it was especially good for CTTH accompanying pericranial     tenderness. Nonetheless, the effectiveness of acupuncture and FSN for CTTH remains     controversial. Several research results showed that symptoms of TTH improve after acupuncture     treatment, but these improvements were more subjective than objective measures. So, the aim     of this study is to determine the cerebral function efficacy of acupuncture and FSN in the     treatment of CTTH, using Headache impact test questionnaire (HIT-6), VAS to evaluate the     subjective symptom and fMRI to detect the objective cerebral function changes.      Intervention: device: acupuncture; Fu's subcutaneous; placebo sham acupuncture   "
11670|NCT03133156|"     The purpose of this study is to determine whether exercise training leads to changes in the     white adipose tissue that are beneficial to the body's regulation of sugar and body weight.   "
8757|NCT03171285|"     Although the mortality rate among soccer players is low, it causes much impact on the entire     community and is a fascinating conundrum. The aim of this study was to evaluate the     cardiovascular risk of soccer referees, to describe the frequency of cardiovascular risk     considering age groups younger and older than 35 years old and to relate the Framingham and     PROCAM indices for the comparison of cardiovascular risk in soccer referees. 50 referees of     Paulista Soccer Federation were subjected to clinical and laboratory based evaluations at the     Center for Sports Health at the Faculty of Medicine of ABC, and divided into two groups:     lower and higher than 35 years of age.   "
8758|NCT03171272|"     The most commonly observed sequel after stroke is muscle weakness, which can also be     identified in respiratory muscles, in the acute and chronic phases, and may compromise the     lung function of these individuals. Studies have shown that lower Pimax values are found in     non-community ambulators, and gait velocity has been reported as an important indicator of     functionality after stroke, with higher gait velocity values associated with greater     community participation and better quality of life.      This study will test the hypothesis that training of the inspiratory muscles is effective in     improving strength and endurance of the inspiratory muscles and functionality, including     speed of gait, functional gait perfomarnce, activities of daily living and quality of life     with stroke subjects.      For this clinical trial, people after stroke will be randomly allocated into either     experimental or control/sham groups. The experimental group will undertake training of the     inspiratory muscles with the Power Breath Medical Classic device regulated at 50% of the     subjects' maximal inspiratory pressure values, five times/week over six weeks, twice a day     for 15 minutes, totaling 30 minutes/day. The control group will undertake the same protocol,     but the participants will receive the devices with a minimal load, wich corresponds to     1cmH2O. Both groups will participate in the rehabilitation program for 6 weeks. At baseline     and post intervention, after the cessation of the interventions, researchers blinded to group     allocations will collect the following outcome measures: maximal respiratory pressures,     respiratory muscle endurance, functional gait performance, activities of daily living and     quality of life. After 12 weeks will collect again maximal inspiratory pressures and     functional gait performance.   "
8759|NCT03171259|"     Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge,     there is a pressing need to collect observational data on treatment patterns, adherence to     performance measures, and outcomes that are relevant to patients and clinicians. To address     this need, the current study will pilot test the research infrastructure and data elements     needed to build a larger, national study collecting of the CLI population. It will also     provide much-needed preliminary information to identify areas of action that can be targeted     in quality improvement programs for this population. Most importantly, it will provide data     on health status outcomes in patients with CLI, as a function of individual patient     characteristics (demographics, socio-economic and clinical background) and the treatments     that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify     potential disparities in the provision of care and patients' outcomes as a function of     patient's characteristics.   "
8760|NCT03171246|"     Crohn's disease (CD) is a chronic inflammatory condition of the gut with severe     complications. There is strong evidence to suggest that diet and gut bacteria are key     components in the onset, perpetuation and management of CD.      An 8-week exclusive liquid diet (EEN) without any normal food is the best treatment for     paediatric CD. The mode of action of EEN remains unknown, but according to recent     publications, the modulation of the gut bacteria drives its therapeutic properties. While     successful, EEN is a challenging therapy to follow. Half of the paediatric EEN patients will     require a nasogastric tube to support treatment, its use in adults is limited, and the need     for a more palatable diet is very well described. Based on these findings, a non-liquid and     more acceptable dietary treatment was recently devised called CD-TREAT (Crohn's Disease     TReatment-with-EATing) diet. CD-TREAT, which is a solid food-based diet designed to replicate     the nutrients and food ingredients composition of EEN, was recently tested in healthy adults     and a rat model of colitis. In order to pilot CD-TREAT diet as a CD induction treatment, 10     children and 10 adults with active luminal CD will be recruited. Once consented, baseline     blood, urine and faecal samples will be collected and the CD-TREAT prescribed for a maximum     of 12 weeks. Another 3 blood, urine and faecal samples will be requested during the 12 weeks.     All the foods/meals of the CD-TREAT diet will be purchased and delivered to the participants'     house by the researcher and the meals which need cooking will be pre-prepared by a     sub-contracted catering company. Blood and faecal inflammatory biomarkers will be measured,     the disease activity assessed with routinely used clinical indices and the faecal bacteria     and its metabolites characterised.   "
8761|NCT03171233|"     Dynamic knee valgus is an inadequate biomechanical movement of multifactorial cause that may     expose the individual to various injuries. The range of motion of ankle dorsiflexion is one     of the possible influencing factors. This study intends to compare the immediate effect of     two techniques on ankle mobility and dynamic knee valgus.   "
8762|NCT03171220|"     The purpose of this study is to see the safety and efficient of neoantigen reactive T cells     (NRTs) combined with programmed cell death-1(PD-1) inhibitor（SHR-1210）in the treatment of     Chinese patients with advanced refractory solid tumors.   "
8763|NCT03171207|"     A novel body weight support device that uses pressurized pants may provide advantages in     delivering gait therapy. The objectives of this study are to test the following hypotheses     that 1) the novel device will allow for increased body weight support while improving or     maintaining the same level of patient comfort; 2) the novel device will yield greater patient     satisfaction with gait therapy relative to current harness systems; 3) therapists will be     more satisfied with the use of the novel device relative to current harness systems; 4) the     use of the novel device will require less total therapist time than a harness comparator; 5)     the use of the novel device will increase therapeutic treatment time when compared with     current harness systems.   "
8764|NCT03171194|"     The purpose of this study is to evaluate the safety of mesenchymal stromal cells (MSCs)     obtained from umbilical cords for the treatment of adults with active systemic lupus     erythematosus (SLE).   "
9451|NCT03161184|"     This study investigates whether training Community Health Workers (CHW) to use a     smartphone-based prenatal counseling application as a job aid instead of the existing paper     based standard is associated with increased women's use of maternal health services in     Singida region, Tanzania.   "
8765|NCT03171181|"     Motor control includes postural control and voluntary movement. For an optimal motor control     it is necessary that brain integrates vestibular, visual and somatosensorial inputs properly,     in a nonlinear way. Vestibular system, as an afferent organ, encodes head position in     relation to gravity and changes in its linear and angular acceleration. As vestibular central     system, it plays an essential role in motor control and in orientation and spatial memory as     well.      When a peripheral vestibular lesion occurs, elaboration, interpretation and processing of     inputs are deficient and therefore motor control is altered to a greater or lesser degree. As     process progress in time, there is a natural neuroplasticity that facilitates recovery or     compensate vestibular function, although sometimes this process is incomplete and requires     vestibular reeducation This study aims to assess changes in balance control, orientation and     handicap perception in one case group with symptomatic unilateral peripheral vestibular     dysfunction, before and after a rehabilitation programme (RV). To compare values obtained at     the beginning and at the end of RV to those achieved by control group. Finally, this research     aims to analyse evolution of spatial orientation quality in symptomatic and non symptomatic     participants.   "
8766|NCT03171168|"     AposTherapy is a home based exercise program utilizing footwear that causes exercise with     normal activity that may significantly improve function in patients with knee osteoarthritis     since patients with knee osteoarthritis have altered mechanics of motion contributing or due     to the presence of the conditions. Capitalizing on the reported excellent adherence and     clinical benefit of ApostTherapy in patients with significant knee OA, the investigators     propose to evaluate this as a conservative treatment that may supplant/supplement traditional     pain medications and physical therapy in an at-risk urban inner city population.   "
8767|NCT03171155|"     To access the safety and performance of the XPro System to facilitate hemostasis in patients     undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the     common femoral.   "
8768|NCT03171142|"     Helium is an inert gas with a density almost one-seventh of that of air. Based on its     properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in     resistance through narrowed airways and consequently decreases the work of breathing.     Participating infants with RSV acute bronchiolitis will be supplied with heliox (ration of 21     oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in     improving their oxygenation. Heliox will act as an additive therapy to improve oxygenation in     patients with lower respiratory tract infection caused by respiratory Syncytial Virus (RSV)     and will decrease the need for more complicated therapies.   "
8769|NCT03171129|"     This study is to evaluate the feasibility of using a pressure limited nasal cannula system     instead of a high flow nasal cannula system in the management of premature babies with     respiratory distress.   "
8805|NCT03170661|"     A deep neuromuscular block (NMB) is often associated with improved surgical conditions     especially in laparoscopic surgery. We previously showed that deep NMB is superior to a     moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia     and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to     investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia     maintenance.   "
8806|NCT03170648|"     This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms     related to receiving chemotherapy.   "
8770|NCT03171116|"     Protein energy wasting (PEW) is a complex syndrome associated with different underlying     illnesses and characterized by loss of muscle, with or without loss of fat. It is a highly     prevalent condition among patients with chronic kidney disease (CKD), associated with     increased morbidity and mortality.      The pathophysiology of PEW in CKD is multifactorial and not yet completely understood. The     potential role in uremic PEW of two of hormones involved in orexigenic/anorexigenic balance,     ghrelin and obestatin, both derived from the ghrelin gene (GHRL), has been investigated in     adults and, less extensively, in children. Aim of our study was to measure AG, UAG and     obestatin concentrations in children with CKD and to assess their potential contribution to     the development of pediatric uremic PEW.   "
8771|NCT03171103|"     prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef     localities   "
8772|NCT03171090|"     Patients will be randomly allocated according to computer - generated tables to one of two     groups, group (A) ultrasonic guided sphenopalatine block using local anasthetic, group (B)     ultrasonic guided sphenopalatine block using saline. Before induction anesthesia the     following will be assessed, time needed to perform the technique, time till onset of the     block, distribution of the block (Opthalmic, Maxillary, Mandibular) by needle brick.Intra and     post- operatively the following will be assesse the quality of operative filed every 30 min     intra-operatively using a pre- defined average category scale (ACS) (from 0 to 5), End tidal     Sevo Flurane concentration will be recorded intra- operatively every 5 minutes, The total     amount of Nitroglycerine used to achieve the target MAP and frequency of propranolol usage     will be recorded,emergence time, postoperative VAS score and amount of meperdine used for     rescue analgesia.   "
8773|NCT03171077|"     The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and     therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the     recovery of the motor function of poststroke hemiparesis patients.   "
8774|NCT03171064|"     Checkpoint inhibitors like the PD-1 antibodies Pembrolizumab and Nivolumab represent standard     of care for patients with metastasized melanoma. Numerous high quality studies demonstrate     that endurance and resistance training in cancer patients is safe and elicits beneficial     effects. However, there is no systematic experience with regard to exercise interventions in     patients undergoing checkpoint inhibitor treatment. Therefore, the Sportivumab Study aimed to     investigate safety, feasibility and effectivity of a 12 week combined resistance and     endurance exercise intervention program during checkpoint inhibitor treatment. It is planned     to enroll 40 patients. Participants will be randomized into an experimental and a wait-list     control group (20 per group). The wait-list control group will receive the exercise     intervention program after week 13 of enrollment.   "
9151|NCT03166137|"     Viral warts are common skin conditions seen in both children and adults. Human papilloma     virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are     extremely common particularly on the hands and feet. Warts can induce hard, thickened skin,     black pinpoints, pain or tenderness with significant morbidity for the patients.   "
8778|NCT03171012|"     Post-stroke hemiparesis causes sequelae in the limbs and also in the trunk and abdomen     structures. The level of physical activity decreases and cardiorespiratory training(CRT) is     indicated to this population to improve the functions of several systems (respiratory,     cardiovascular, muscular). The application of Proprioceptive Neuromuscular Facility(PNF)     would imply in the awareness and greater harmony of the functions performed by the trunk of     this individual. The objective of this study is to evaluate the effects of respiratory and     trunk characteristics of the PNF associated with Cardiorespiratory training in quality of     life, gait, distance traveled, peak oxygen consumption, respiratory muscle strength, thoracic     cavity volumes, mobility and diaphragmatic thickness of individuals with post stroke.   "
8779|NCT03170999|"     It has been observed that COPD exacerbations are under-reported in China. One of the reasons     for this is Chinese subjects with COPD cannot describe the symptoms of exacerbation mentioned     in English. Hence this study aims to create a tool called CERT that will help Chinese     physicians and subjects with COPD to recognize and report exacerbations. The study will be     carried out in 4 stages: item identification, cognitive briefing, item reduction and creation     of final CERTs. Two CERTs will be prepared, one for subjects with COPD and another for     physicians. A total of approximately 200 subjects will be included in the study and each     subject will contribute to only one step.   "
8780|NCT03170986|"     This study aims to test the hypothesis that a multi-sectoral agricultural and microfinance     intervention designed to improve household food security, prevent antiretroviral treatment     failure, and reduce co-morbidities among people living with HIV/AIDS will lead to     improvements in the nutrition, health and development of children under 5 years old who     reside in households of adults who participate in the Shamba Maisha intervention.   "
8781|NCT03170973|"     Introduction: The metabolism of fatty acids in plasma is modulated by their availability in     plasma. Individuals with increased weight have increased plasma fatty acids and physical     exercise seems to favor the metabolic responses of fatty acid mobilization. Objective: To     test the hypothesis that the physical exercise of acute way changes the fatty acids of medium     chain of the serum of individuals with increase of the corporal weight. Method: Including 66     women, randomly divided into two groups, control and experiment, overweight, sedentary, and     between 18 and 30 years of age. After a 12-hour fast, basal blood collection will be     performed. The experiment group, 12 hours after the first collection, will be submitted to a     physical exercise session with energy expenditure of 250Kcal. The volunteers in the control     and experiment group will make a second blood collection 24 hours after the first one. The     fatty acids will be dosed: pelargonic, azelaic, elaidic and oleic by gas chromatography.     Intra and intergroup comparisons will be made using the t test for independent and dependent     samples, p <0.05.   "
8782|NCT03170960|"     This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary     efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in     subjects with advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter,     urethra) or renal cell carcinoma (RCC). The study consists of two stages: in the Dose     Escalation Stage, an appropriate recommended cabozantinib dose for the combination with     standard dosing regimen of atezolizumab will be established. In the Expansion Stage,     tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy     of the combination treatment in these tumor indications.   "
8783|NCT03170947|"     Deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (RA), due to the     interaction between inflammation and abnormal biomechanical. These cause instability in the     hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar     forefoot and more pain during daily activities. Non-pharmacological interventions (insole,     footwear) have an important role, reducing pain and disability, increasing the effectiveness     and improving daily activities.   "
8784|NCT03170934|"     The proposed study will conduct a preliminary investigation of the effectiveness of two     different psychotherapy classes at the Mental Health Crisis Response Centre (CRC) in reducing     suicidal ideation. One class - Managing Difficult Emotions (MDE) - is an 8-session,     Dialectical Behavioral Therapy-informed program that focuses on skills related to increasing     tolerance for distress and emotion regulation such that harmful behaviors are reduced. The     other class - Mindfulness-Based Cognitive Behavioral Therapy (CBTm) - is a 4-session program     that focuses on challenging and changing maladaptive beliefs and behaviors in order to reduce     distress. Both classes are delivered in lecture style, PowerPoint format. The investigators     will also examine the effectiveness of participation in psychotherapy classes in reducing     symptoms of general psychological distress, depression, anxiety, and emotion dysregulation.   "
8785|NCT03170921|"     The aim of this study was to characterize the psychophysiological demand in different     Capoeira performances in male experienced individuals. Eleven men healthy and experienced in     Capoeira. Participants were invited to five visits in different days: 1) anamnesis and     anthropometric assessment; 2) aerobic performance assessment; 3 to 5) performance of 90s in     three Capoeira styles (Angola, Benguela and São Bento). Main Outcome Measure(s): The     physiological demand through the heart rate (HR), R-R interval (RRi), blood pressure (BP),     blood lactate ([Lac]), and glucose ([Gluc]) and rating perceived effort (RPE), feeling scale     (FS) and perceived activation (PA) were assessed after 10min of rest and during recovery (1,     3, 5, 7 and 9min) of each performance. HR and RRi records also occurred during each     performance.   "
8786|NCT03170908|"     The study is designed to observe the impact of improved measures of the fidelity on the     community delivery of Interpersonal Psychotherapy. Pairs of therapist-patient dyads will be     observed, first to develop and test brief measures of fidelity, and then to correlate those     measures with symptomatic outcomes.   "
8787|NCT03170895|"     The study aims to test if combination of sorafenib and omacetaxine mepesuccinate (OM, also     known as homoharringtonine) results in durable composite complete remission (CRc) in patients     with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML) carrying     FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).   "
8788|NCT03170882|"     The purpose of this study is to compare the effect of ixazomib+dexamethasone (ixa+dex) versus     pomalidomide+dexamethasone (pom+dex) on progression-free survival (PFS) in participants with     relapsed and/or refractory multiple myeloma (RRMM) who have received at least 2 prior lines     of therapy, including lenalidomide and a proteasome inhibitor, and are refractory to     lenalidomide but not refractory to proteasome inhibitors.   "
8789|NCT03170869|"     The purpose of this study will be to prospectively evaluate the outcomes of patients with     hepatocellular carcinoma (HCC) who undergo DEB-TACE (drug-eluting bead trans-arterial     chemoembolization) with the Surefire Precision Infusion System for intentional effect of     down-staging patients to OLT.      Patients with HCC and who are considered candidates for liver transplantation but outside     Milancriteria and meet the eligibility criteria will be enrolled in the prospective single     arm study.      Results of the prospective cohort will be compared to matched historical control patients who     were previously treated with DEB-TACE, delivered with standard endhole catheters. This     includes all patients treated at the University of Colorado since 2009 treated with 100-300     micron beads for whom follow-up is available.   "
8790|NCT03170856|"     Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout     their recovery. Cerebrovascular function, heart rate, and symptom duration will be monitored     throughout.   "
8791|NCT03170843|"     This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the     rate of surgical site infection in patients who undergo open abdomen surgery for     gastrointestinal tract.   "
8792|NCT03170830|"     This is an observational diagnostic study that aims to evaluate the diagnostic value of     circRNA-Uck2 in Acute Myocardial Infarction (AMI) in adults as compared to healthy and     unstable angina controls. Rapid and adequate diagnosis of AMI is of great importance to     enable a rapid start of treatment, save large tracts of dying myocardium, reduce the infarct     size,and thereby decrease the risk of subsequent heart failure.   "
8793|NCT03170817|"     Accurate measurements from a non-invasive test like myocardial perfusion positron emission     tomography/ computed tomography (PET/CT) may decrease the need for invasive procedures such     as cardiac catheterization.The investigators wish to see if the measurements from cardiac     catheterization can be predicted using a non-invasive 13N-NH3 digital PET/CT scan.   "
8807|NCT03170635|"     A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led     Refreshing Recess program designed to build capacity of recess supervisors to create a     positive recess experience so that all students can successfully participate in and enjoy     active play and socialization with peers.   "
8808|NCT03170622|"     Please see description below   "
8809|NCT03170609|"     This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study     evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged     18 to 49 years of age with no history of group B streptococcal vaccination will be randomized     to receive either a single intramuscular dose of multivalent group B streptococcus vaccine     (various formulations at 3 dose levels) or a placebo (saline control).   "
8794|NCT03170804|"     The purpose of this registry is to collect uniform genomics-centered data on patients with     nodular thyroid disease and cancer in a prospective fashion. After initial clinical     evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation     and a needle biopsy of the thyroid (fine needle aspiration (FNA) or core biopsy) as     clinically indicated. Biopsy samples will be evaluated cyto-pathologically. A     molecular/genomic profiling will be obtained using Thyroseq v2 test. Surgical treatment will     be performed as per clinically determined indications. Standard surgical pathology will be     processed and reported per the institutional policy and procedures. A molecular/genomic     profiling will be obtained using Thyroseq v2 on the surgical specimen. All patients     undergoing thyroid nodule work-up may be enrolled. The registry will collect patient     demographic and clinical data, cytopathology reports, and surgical pathology reports and     slides (if/when a review is required).   "
8795|NCT03170791|"     This study will find out whether electrical stimulation of a nerve called the vagus nerve     is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20     patients will be recruited if they had a stroke between 4 and 48 months previously and have     been left with reduced function in the affected arm. Patients will receive 3 sessions of     physiotherapy per week for 6 weeks. Each session will last 1 hour during which the patient     will be asked to perform specific movements e.g. shuffling cards, reaching for a shelf. With     each arm movement the therapist will turn on a stimulator which is worn clipped to the     patients ear. This will deliver a short burst of electricity creating a mild tingling     sensation.      At the end of the session, the stimulator will be removed and the patient will be asked to     rate the level of any discomfort or fatigue they experienced as well as any other side     effects. The therapist will also record whether the stimulator device interfered with the     therapy in any way. A heart tracing will be performed at each visit to check the heart     rhythm. At the start and end of the 6 week course of physiotherapy, patients arm weakness and     level of arm function will be assessed, as well as their general levels of fatigue, mood and     quality of life. These will be reassessed at 1 month and 6 months after the course of     physiotherapy has ended. The investigators will also interview patients to establish how they     found the treatment itself. If the vagal nerve stimulation combined with physiotherapy is     acceptable to patients and therapists and there are no safety concerns, the investigators     will plan a larger trial of this treatment in stroke patients.   "
8796|NCT03170778|"     The purposes of this study are to identify indicators of vision problems and ocular     abnormalities in patients with a Fontan circulation through a standardized questionnaire and     to correlate the intraocular pressure measured with the Icare tonometer with central venous     pressure measured with the VENUS 2000 CVP non-invasive system to determine whether     intraocular pressure can be used as a surrogate measure of increased central venous pressure     in patients with a Fontan circulation.   "
8813|NCT03170557|"     Pain is one of the most common problems in patients with spinal cord injury (SCI) and     persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often     poorly responsive to pharmacological therapy. Attention has been paid to the use of     non-pharmacological therapies and interventional techniques in treating pain in other     clinical conditions, and acupuncture has been the treatment most used and appreciated for its     effectiveness. However, only few studies are available on the use of acupuncture in SCI     patients. The present randomized, comparative trial aims to clarify the efficacy of     traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in     subjects with spinal cord injury, by overcoming the biases reported in previous studies.   "
9452|NCT03161171|"     The study quantitates behavioral challenges in mucopolysaccharidosis type I-III and parental     coping strategies   "
8797|NCT03170765|"     Measles is a preventable infectious viral disease. Since 1985, India has been administering a     single dose of measles vaccine to all infants at 9 months of age. This age was chosen to     balance the disappearance of maternal (transplacental) antibodies with the increasing risk of     developing measles. Thus infants are expected to get protection against measles by acquired     maternal measles antibodies derived trans-placentally from the mother for the first 9 months     of life. Thereafter vaccine-induced antibodies are expected to protect infants.     Seroconversion after measles vaccination does not take place as long as maternal measles     antibodies persist in the infant. However, it is widely recognized that a substantial     proportion of measles infection (10 to 15%) can occur among infants before the age of measles     vaccination. Further, two small cohort studies done in our institution confirm that the     majority of infants lose maternal antibodies by six months of age, making them susceptible to     measles.This argues strongly for anticipating measles vaccination to an earlier age. However,     such early vaccination has the risk that residual maternal antibodies (even if insufficient     to protect infants) can neutralize the antigen in the vaccine, rendering vaccination     ineffective. Therefore, a careful balance has to be chosen so that low levels of circulating     maternal antibodies do not interfere with infants' response to vaccination. However, there is     no prospective study in Indian infants to determine the seroconversion and sero-protection     rate of earlier vaccination.      This study has following aims and objectives:        1. To study the level of measles specific immunoglobulin G (IgG) antibodies in a cohort of          term infants followed from birth to 9 months of age; and the pattern of antibody decline          in them.        2. To compare the levels of antibodies in infants at these time points and correlate the          levels with the antibody level in the respective mothers at the time of delivery.        3. To compare the efficacy and safety of three different measles vaccination schedules in a          cohort of term infants viz (i) vaccination at 9 months of age (current practice), (ii)          vaccination at 7.5 months and 9 months of age, and (iii) vaccination at 6 months and 9          months of age.   "
8798|NCT03170752|"     This study is a randomized controlled trial (RCT) and there will be two groups: an     intervention group and a control group. Nurse practitioners (NPs) across Newfoundland and     Labrador (NL) who agree to participate will be randomly assigned to one of the two groups.     The NPs in the intervention group will be asked to screen about 30 individuals aged 40-74     years without established cardiovascular disease (CVD) that currently come to their clinics.     The NPs will be asked to screen these patients for CVD using a set of specific data     collection tools that will be in electronic format. The control group will carry on with     usual practice. Their charts will be reviewed by the researchers at a later date. At the end     of the study, the screening program, with tools and strategies for CVD screening, will be     given to NPs in the control group.   "
8799|NCT03170739|"     Acute kidney injury (AKI) is associated with complications that may lead to multiorgan     dysfunction and potentially to multi-organ failure after major surgery. Dexmedetomidine is a     highly selective alpha(2)-adreno receptor agonist widely used during anesthesia. In animals,     dexmedetomidine has shown protective effects in AKI after surgery. Dopamine (DA) is an     organic chemical of the catecholamine and phenethylamine families that has been widely used     to increased renal blood flow and urine output during surgery. However, the clinical effects     of dexmedetomidine and dopamine on renal function are still controversial. The aim of this     study is to investigate whether dexmedetomidine and dopamine have positive effects on renal     function after selective major surgery.   "
8800|NCT03170726|"     This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv)     ibuprofen on pain occurring during and after the mandibular third molar surgeon   "
8801|NCT03170713|"     this study was planned to investigate the antiinflammatory activity of preemptive intravenous     ibuprofen on inflammatory complications such as edema and trismus after third molar tooth     surgery   "
8802|NCT03170700|"     The goal of this study is to further increase the impact of a validated and widely-used     Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices     resulting in the development of healthier patterns of child eating behavior and food intake.     Additionally, the effectiveness of two delivery strategies for adding feeding video-based     content will be examined (in-person versus online lessons).   "
8803|NCT03170687|"     This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth     metatarsal fracture (Zone II).   "
8810|NCT03170596|"     Post acne scarring is a common complication of acne. Cosmetic appearance of the post acne     facial scarring can be improved by various methods. Among the procedural methods     microneedling (1) is a novel and a promising option. It is a minimally invasive day care     procedure for the management of atrophic acne scars. Topical tazarotene 0.1% gel is an     effective medical method in the management of acne vulgaris and macular acne scars (2, 3).     Based on its mechanism of action and role in collagen synthesis, topical tazarotene is a     logical choice to investigate for the management of atrophic post acne scars. This is a pilot     study comparing microneedling and topical tazarotene for the treatment of atrophic post acne     scarring in regard to extent and rapidity of improvement, patient satisfaction and any     adverse events if any.      Thirty six subjects with grade 2 to grade 4 atrophic post acne scars, classified on the basis     of Goodman's Qualitative classification (4) criteria will be recruited. Goodman's qualitative     and quantitative acne scarring grading system scoring will be performed for the assessment of     severity of acne scarring at baseline. The face of each patient will be randomized for     monthly microneedling on one side and topical tazarotene 0.1 % gel once a day local     application on opposite side, using computer generated random number table. Follow ups will     be done at every month until treatment completion (3 months) and 3 months after the last     treatment session. Goodman's qualitative and quantitative acne scarring grading system     scoring will be performed at 3rd and 6th month follow up visits. An improvement by two grades     will be considered as excellent, one grade will be rated as good and no up gradation will be     labelled as poor response. Patients will be also assessed by a blinded observer for clinical     improvement and scored on a scale of 0 (no improvement) to 10 (maximum) at 3rd and 6th month     follow up visits with the help of serial photographs taken under consistent background,     position and lighting. All patients will be instructed to assess themselves using Patients'     Global Assessment Score 0 (no response) to 10 (maximum) at 3rd and 6th month follow up     visits.      The investigators hope the outcome of the present study may propose a newer medical modality     for acne scarring, i.e topical tazarotene 0.1% gel, which can be used at home, obviating the     need for physician dependant microneedling procedure.   "
8811|NCT03170583|"     The purpose of this post approval study is to evaluate the long-term safety of the FDA     approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse     generator (IPG) such as the Accent MRI™, Assurity MRI™, Endurity MRI™ pacemaker, or similar     model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.   "
8812|NCT03170570|"     this is a prospective clinical trial using intensity modulated radiotherapy（IMRT）for the     treatment of cervical cancer patients with recurrent disease within the previously irradiated     field. Sixty patients will be enrolled after careful selection to meet the inculding criteria     and excluding criteria.A primary course of 36Gy will be prescribed to the recurrent site and     a further 9-24Gy of dose escalation will be prescribed to the gross tumor volume in the     second course according to the toxicities and the shrinkage of tumor. Weekly concurrent     cisplatin of 30mg/m2 by five weeks will be administrated intravenously to the selected     patients.Acute and late toxicities will be monitored and survival endpoints will be tracked     with our follow-up protocol to evaluate the safety and effecacy of this approach.   "
8814|NCT03170544|"     This is an active- and placebo-controlled, single-site, three-part trial of MK-1092 in     healthy adult participants and in participants with type 1 diabetes mellitus (T1DM). The     primary hypothesis for this study is that at a dose with sufficient safety, the mean maximal     glucose infusion rate (GIRmax) after single subcutaneous (SC) administration of MK-1092 in     adult participants with T1DM is within an acceptable range. (Part 3)   "
8817|NCT03170505|"     The fact that still exist is which method for repairing of secondary cleft palatal fistula is     the best. This study will have shown whether using of Acellular dermal Matrix decreased the     fistula formation versus using Conchal Cartilage during secondary fistula. Among studies that     published, they have not consensus for using acellular dermal matrix. Most of the questions     are about cost effectiveness, time that surgery and rehabilitation need and patient risk (     risk of transmission disease from other human tissue )   "
8818|NCT03170492|"     Explanation of the study: As the older adult population continues to rise, so will normal     cognitive aging. This increase raises concern for maintaining cognitive function and possibly     delaying the onset of disorders such as dementia. Cognitive training (CT) is one potential     solution which may be done using computer programs, pencil-and-paper problem solving     activities, or everyday tasks. Traditional, skilled occupational therapy (OT) is not     reimbursed for this type of preventative or maintenance services. CT may be a fundable answer     for older adults to maintain or even improve cognitive function. The purpose is to determine     if computerized CT, utilizing a specific program (RehaCom), improves executive functioning in     the older adult with mild cognitive impairment, as compared to pencil-and-paper CT.      How study is performed: Participants who meet the inclusion criteria will complete a     9-question demographic survey and pre-test standardized cognitive tests. The experimental     group will complete RehaCom computer training and the control group will complete     paper-and-pencil based training. All trainings will take place at Mercy LIFE and will be     conducted by trained OT students. Subjects will complete a total of 480 minutes of training     over a 12-week period, within 30 to 60 minutes sessions. After the 480 minutes of training,     subjects will complete the cognitive post-tests.      How data is collected, de-identified and analyzed: Participants who enroll will be assigned a     code number linked to their first and last name. This coding will de-identify participants     before analyzing or reporting. All signed forms, data collected, and data identified will be     kept in a locked cabinet in the researcher's office. All stored files will be shredded one     year after the study.      Interventions/tests/medications:      Computerized CT: RehaCom is a computer program that was designed to assist cognitive     rehabilitation. The program targets attention, concentration, memory, perception, and     problem-solving, with trainings lasting for a total of 480 minutes over 12 weeks.      Pencil-and-paper CT: Various pencil-and-paper exercises to improve attention, concentration,     memory, language, and orientation will be used. Such exercises may include word puzzles,     calculation or number puzzles, and map reading, for a total of 480 minutes of training over     12 weeks.      Potential risks: Risks of feeling segregated are minimal, as all members have been offered     the opportunity to use the site's computer room. Risks may include cognitive fatigue (in both     groups) or overstimulation during computer use. Breaks will be given at any sign of these     symptoms. There is a small possibility that the participant may become too overwhelmed or     stressed with the cognitive training. Upon notice of these symptoms, activities will cease     immediately.      Potential and expected benefits: Participants may gain a greater insight into cognitive     abilities and improvement of executive functioning skills. Increased knowledge on effects of     using cognitive software in a community-based setting may also occur. Mercy LIFE will receive     the benefit of continued use of the RehaCom software and laptop as the equipment will be left     at the site. Additionally, these findings may help other community-based sites incorporate     specific cognitive training for other older adults.   "
8819|NCT03170479|"     i. To examine the impact of malnutrition on development quotient of children      ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the     development quotient of severe acute malnourished children under five year of age.      iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF     rehabilitation on growth and development of malnourished children.   "
8820|NCT03170466|"     Patients with advanced heart failure (HF) typically experience significant burdens that     negatively impact their quality of life. Although palliative care has been shown to improve     patient outcomes in other serious illnesses, insufficient data exist to support its use in     HF. Furthermore, the demand for palliative care in serious illness outstrips the available     supply of certified palliative care clinicians. This pilot trial will assess the feasibility     and acceptability of training cardiology nurses in basic palliative care skills and their     ability to deliver this care alongside usual HF management.   "
8821|NCT03170453|"     This study will investigate and confirm the efficacy of two psychological treatments for     adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive     remediation intervention that aims to help adults with problems in thinking, planning, and     socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that     aims to help adults learn about their condition, manage their emotions and stress, improve     their social skills, and cope with everyday problems.   "
8822|NCT03170440|"     Post traumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) frequently     co-occur, and these patients often have disrupted sleep. Poor sleep quality is associated     with several poor heath outcomes that overlap with those that are experienced in PTSD. These     can include poor cognitive performance and difficulty with emotional regulation. Effective     treatment of sleep problems in these individuals could substantially improve these symptoms     and quality of life. Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive     electrical stimulation technique that has been previously shown to moderate the response of     the sympathetic nervous system and reduce hyperarousal in patients with mTBI and PTSD. In     this study, our objective is to determine the effect of tVNS in changing sleep architecture     and subjective sleep quality, as well as changing emotional and cognitive performance.   "
8823|NCT03170427|"     Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring.     Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg     (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing     elective cesarean section; secondary, to compare the duration and quality of analgesia and     anesthesia   "
8824|NCT03170414|"     The primary objective of this study is to evaluate the safety of solid organ transplantation     using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in     HIV-positive recipients.      HIV-positive individuals who agree to accept and receive a solid organ transplant from and     HIV-positive donor will be followed to determine the safety and efficacy of this practice.   "
8825|NCT03170401|"     The aim of this study is too determine the effect of enteral protein supplementation on     biochemical measures of inflammation and protein metabolism in critically ill surgical     patients. The investigators will also collect data on important clinical outcomes, including     infectious complications, duration of mechanical ventilation and other measures of recovery     from critical illness.      Hypothesis: That early supplemental protein will increase serum concentrations of     transthyretin at three weeks after the onset of illness or injury. Secondarily, the     investigators will test whether supplementation, reduces infectious complications and     increases ventilator-free days.   "
8826|NCT03170388|"     A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group,     Clinical Study in the Treatment of Acne Vulgaris   "
8827|NCT03170375|"     Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF),     and suffer poor quality of life, frequent hospitalizations, and high death rates. Older     Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal     cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However,     it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive     information from experimental animal models and some human studies suggests that dietary     patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF.     Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent     heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of     HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to     emphasize prevention of disease and population health.   "
8828|NCT03170362|"     The focus of this application is on the impact of providing depressed Veterans and their     providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The     project focuses on whether and how patients and providers use genetic test results given to     them at the time an antidepressant is to be initiated to treat Major Depressive Disorder     (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most     common conditions associated with military service and combat exposure, increases suicide     risk, and worsens the course of common medical conditions, making it a leading cause of     functional impairment and mortality. Validation of a PGx test to personalize the treatment of     MDD represents an important opportunity to improve the healthcare of Veterans.   "
8829|NCT03170349|"     The purpose of this study is to assess the safety and clinical outcomes of the Edwards PASCAL     Transcatheter Mitral Valve Repair (TMVr) System.   "
8874|NCT03169751|"     This is an observational study of subjects receiving standard of care therapy, while admitted     to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with     Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be     compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in     adjunct to standard of care.   "
8830|NCT03170336|"     Nowadays, the prevalence of chronic kidney disease (CKD) in China is about 10.8%,and nearly     120 million people suffer from CKD, which has become a serious public health problem in     China. Study confirmed that proteinuria is an independent risk factor for the continuous     deterioration of glomerular filtration rate (GFR) in patients with CKD. So it is of great     significance to explore the strategy of reducing proteinuria.      According to our previous study, Amiloride can inhibit the expression of uPAR in podocytes     and reduce proteinuria, This clinical trial aims to evaluate the effect and safety of     Amiloride in decreasing proteinuria for patients with Chronic Kidney Disease.   "
8831|NCT03170323|"     Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in     adults. There are few randomized clinical trials regarding the therapeutic effect of     mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to     evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in     inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic     membranous nephropathy.   "
8832|NCT03170310|"     Subject ever received a standard chemotherapy solution progression or recurrence or can't     tolerate chemotherapy with advanced esophageal squamous carcinoma.   "
8833|NCT03170297|"     The purpose of this study is to pilot data for a systematic molecular characterization of     pathophysiologic perturbations incurred by snake envenomation and compare this to other     inflammatory physiologic states such as trauma and sepsis. This sub-study will analyze     samples of participants enrolled under the parent study Surgical Critical Care Initiative     Tissue and Data Acquisition Protocol.   "
8834|NCT03170284|"     The purpose of this study is to examine the efficacy of Bevacizumab in addition to     platinum-based chemotherapy for first-line treatment of participants with advanced stage     (IIIB/IV) non-small cell lung cancer (NSCLC) other than predominantly squamous cell     histology.   "
8835|NCT03170271|"     The purpose of this study is to investigate the effect of benralizumab on the rate of asthma     exacerbations, patient reported quality of life and lung function during 24-week treatment in     patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of     patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps.   "
8837|NCT03170245|"     Every year, 100,000 neonates are born with hemoglobinopathies around the world. Thalassemia     is the most common heterogeneous disease of the human being . It is a disease of high     prevalence in Mediterranean, Indian, North Chinese, and Pacific populations. Recently, the     quantity and quality of the life of these patients have been significantly improved by     regular transfusion and iron chelating therapy .   "
8838|NCT03170232|"     This is a pilot study to investigate the effect of danirixin hydrobromide 35 milligram (mg)     tablets on lung function and health related quality of life (HRQoL) in subjects with mild to     moderate airflow obstruction and a demonstrated history of decline in forced expiratory     volume in one second (FEV1). Specifically, this study aims to assess whether or not danirixin     has the potential to impact disease progression in subjects with a COPD progression score     indicating they are likely to decline based on 5 year data from a COPDGene study and support     the conduct of a larger Phase III study for disease progression. Subjects will receive either     placebo or danirixin 35 mg tablets (as hydrobromide hemihydrate salt) twice daily for 52     weeks (12months). Study subjects will continue with their standard of care inhaled     medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while     receiving study treatment. This study will be an ancillary study within the COPDGene study     investigating the enrichment strategy for assessing disease progression. Potential subjects     most likely to decline from the well established COPDGene cohort, will be based on data     collected over the initial 5 year period. With the use of an enriched population, it is     anticipated that one year of treatment will be sufficient to detect a trend in altering     disease progression. Approximately 130 subjects will be screened to enroll 100 subjects in     this study. The data from this study will provide useful information in determining whether     to progress to a Phase III study to explore an indication for slowing disease progression.   "
8839|NCT03170219|"     To determine if a strategy of early discharge using a novel subcutaneous delivery system for     parenteral furosemide can improve clinical outcomes within 30 days of randomization (days     alive and outside the hospital) compared to usual care.   "
8840|NCT03170206|"     This trial is being conducted as a possible treatment for lung cancer with a specific change     in the KRAS gene.      The drugs involved in this study are:        -  Palbociclib        -  Binimetinib   "
8841|NCT03170193|"     A study to assess the safety and tolerability of AMG 529 following single, ascending doses     administered subcutaneously (SC) or intravenously (IV) in healthy subjects   "
8842|NCT03170180|"     1. Metastatic gastric cancer patients who failed standard treatment will be enrolled in          this study.        2. After consent form, patient-derived cancer cell will be collected and tested with 3          kinds of drugs (sunitinib, gefitinib, imatinib).        3. Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and          patients will be treated with sensitive drugs.        4. Patients will be evaluated every 6 weeks.   "
8843|NCT03170167|"     The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and     for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess     the efficacy and feasibility of these group visits. During 2017-2018, the investigators will     recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this     study. The study will be a pre-post evaluation, without a control group, using validated     patient-report assessments at baseline, after completion of the group visits, and 3 months     later. The primary outcome variables will be physical and mental wellbeing, stress, mood,     resilience, mindfulness, and social support. Paired t tests will be used to assess changes     from baseline to immediately post-intervention & 3 months post-intervention. The     investigators will also calculate Cohen's d effect sizes, to help them understand the degree     to which an effect is present in the population.   "
8844|NCT03170141|"     This study is for patients that have a type of brain cancer called Glioblastoma multiforme     (GBM). This study will combine two different ways to fight cancer: antibodies and CAR-T     cells. Several immune checkpoint antibodies have been examined on various tumors with good     outcomes. GBM is known to express increased levels of surface antigens that can be targeted     by CAR-T cells. Thus, in this study, the 4SCAR-IgT cells targeting GBM surface antigens will     be infused in dose escalation cohorts.   "
8845|NCT03170128|"     The purpose of this study is to investigate the effects of physical therapy as part of the     non-operative treatment of radial head fractures.There is currently no data to support the     use of physical therapy in the non-operative treatment of radial head fractures. Likewise,     there is no data that shows that physical therapy is harmful to patients being treated     non-operatively for radial head fractures. Investigators believe that prescribing physical     therapy for patients with non-displaced radial head fractures treated non-operatively is     unnecessary, and that that it would be equally efficacious to teach patients simple     stretching exercises that they could perform by themselves. Subjects will be randomized into     2 groups: Group 1 - Patients will be prescribed physical therapy within the first month     following fracture; Group 2 - Patients will be given simple stretching exercises to perform     at home and will not be given a prescription for physical therapy. Patients who agree to     participate in this study and sign the informed consent will be randomly assigned to one of     the two groups.   "
8846|NCT03170115|"     The benefit of aspirin in cancer of the colon and rectum is already known. Recently, it was     described its potential activity during chemoradiotherapy, with higher rate of tumor     downstaging. Furthermore, induction chemotherapy followed by chemoradiation represents an     attractive approach, with more favorable compliance and toxicity profiles. The aim of this     study was to evaluate the efficacy of total neoadjuvant treatment and assess the efficacy and     feasibility of aspirin use during chemoradiotherapy for high-risk rectal cancer.   "
8847|NCT03170102|"     The study involved a one-group (n=19) mixed methods design using using pretest-posttest     surveys and qualitative analysis of written reflections was used to explore the meaning and     outcomes of participation in the building capacity process.   "
8848|NCT03170089|"     This study is designed to evaluate the effect of oral health educational program on the     awareness and oral health status of children with Insulin Dependent Diabetes Mellitus.   "
9861|NCT03157037|"     This study will evaluate the safety and tolerability of IdeS in patients with severe anti-GBM     (Glomerular Basement Membrane) disease receiving standard care consisting of     pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with     plasma exchange (PLEX).   "
8849|NCT03170076|"     -  Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that          primarily affects the liver. It is one of the main causes of chronic liver diseases          worldwide .        -  According to World Health Organization (WHO), 2011 , Egypt has particularly high rates          of Hepatitis C (22%).        -  Hepatitis C virus (HCV) is known to induce both hepatic and extra-hepatic          manifestations. About 17% of HCV patients present with at least one skin manifestation,          which can be directly or indirectly induced by chronic HCV infection .   "
8850|NCT03170063|"     The overall objective of this study is to compare the performance of available oligomeric and     phosphorylated a-synuclein assay in cerebrospinal fluid and blood.   "
8851|NCT03170050|"     A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face,     comparative, non-inferiority, Medical device Clinical trial.      This study is randomized, evaluator and subject blinded, split-face medical device Clinical     trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane     Lidocaine) in right or left nasolabial folds.   "
8852|NCT03170037|"     This study hypothesizes that a novel reversal V-E ventilation technique will retain its high     efficiency as that of standard V-E technique and will be easier to use.   "
8853|NCT03170024|"     Currently, both oral and written health education make certain assumptions about the health     literacy of patients and their parents. The prevalence of health literacy issues is unknown     in the adult congenital heart disease (CHD) population. Having a better understanding of a     patient's and/or their parents' health literacy will help us develop appropriate education     and teaching tools to meet the patient's and their parents' needs.   "
8854|NCT03170011|"     Patients with cardiac disease have been shown to have deficits in activities such as standing     up from a chair. The Biodex Sit2Stand Trainer is a new device meant to improve sit to stand     performance by providing a lifting force through the seat to help the individual stand. The     amount of lift can be graded to help improve leg strength, endurance, and function over time.     The device has the potential to be a form of training for those in cardiac rehabilitation who     have limitations in standing from a chair.   "
8855|NCT03169998|"     -  It has been known that the recent application of a goal-directed fluid therapy (GDFT) to          the intraoperative fluid infusion in patients contributes to decreasing the prevalence          of postoperative complications and shortening the length of study in the intensive care          unit as well as hospital stay compared with conventional methods.        -  Laparoscopic surgery is in a trend that its application is being expanded recently, but          there has been no report on the application of GDFT to laparoscopic surgery so far.        -  To this end, this study aims to apply the intraoperative GDFT protocol in patients          undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether          there is any difference in postoperative recovery and incidences of postoperative          complications, by comparing with patients applied with the fluid therapy using existing          conventional methods   "
8856|NCT03169985|"     The aim of this prospective, open-label, randomized, single center study is to compare the     effect of usual dose rosuvastatin plus ezetimibe and high-dose rosuvastatin on modifying     atherosclerotic plaque.   "
8857|NCT03169972|"     The purpose of this survey is to understand the following items in the actual clinical use of     ADYNOVATE in patients:        1. Unexpected adverse drug reactions        2. Occurrence of adverse drug reactions in the actual clinical use        3. Factors that may affect safety and efficacy        4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII          deficiency (hereinafter hemophilia A)        5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy          and on-demand therapy   "
8858|NCT03169959|"     A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product     (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin     /10 mg Dapagliflozin /1000 mg Metformin XR Relative to Individual Components (Onglyza and     XIGDUO XR) Co-administration. A randomized, open-label, cross over design has been chosen to     minimize the effects of between-subject variability and any period effects on the overall     results.   "
8859|NCT03169946|"     Considering the beneficiary properties of both Chlorhexidine (CHX) and Metronidazole (MTZ)     such as property of substantivity and diffusion of these drugs on the external surfaces     through the anatomical communication channels in between the root canals and periodontium,     may be utilized as an alternative approach for the delivery of drug ( intracanal medicament)     in the deep periodontal pockets in concurrent endodontic- periodontic lesion with     communication lesions. Thus the aim of study is to conduct a prospective randomized     controlled clinical trial to evaluate and compare the effects of CHX-MTZ combination with     chlorhexidine alone as an intracanal medicament on periodontal healing in concurrent     endodontic- periodontic lesion with communication.   "
8860|NCT03169933|"     Patients with high risk prostate cancer may benefit from radiotherapy after radical     prostatectomy. The investigators postulated that adjuvant androgen deprivation therapy (ADT),     radiation dose escalation, and selective pelvic irradiation may improve outcome. A phase II     trial was designed to prove that combined-intensified-modulated-adjuvant (CIMA) treatment may     improve 5-year biochemical relapse free survival (bRFS) from 75% to 90% in high risk     patients. The delivered dose to tumor bed and pelvic nodes was 64.8-70.2 Gy and 45 Gy (57% of     patients), respectively, and 69% received ADT.   "
8861|NCT03169920|"     This study evaluates the efficacy of M-MIST with or without PRF in the treatment of intrabony     defects.Taking into consideration of advantages of PRF and M-MIST it was hypothesised that     this combination (PRF+M-MIST) would be more beneficial in achieving healing of intrabony     defects. Furthermore the concomitant use of Platelet Rich Fibrin with M-MIST has not been     previously attempted in periodontal practice.   "
8886|NCT03169595|"     The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat     aggressive clinical characteristics, including multifocal presentation and occasional lymph     node involvement.      The investigators reviewed the clinicopathologic and radiologic characteristics of bone and     soft tissue epithelioid hemangioma in patients treated at our institution with available     tissue for molecular testing.      The hypothesis is that epithelioid hemangioma may present with multifocal involvement and     rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent     prognosis.   "
8862|NCT03169907|"     INTRODUCTION      Circulatory changes associated with fetal anemia have an important role in maintaining     sufficient tissue oxygenation. With fetal anemia, hyperdynamic circulation and increased     cardiac output occurred. In current practice, using Doppler in assessment of the peak     systolic velocity (PSV) of the middle cerebral artery (MCA) is the main parameter in     screening of fetal anemia. Myocardial performance index (MPI) is a noninvasive technique that     evaluates systolic and diastolic cardiac function by pulsed Doppler.      Patients and Methods:      This prospective study will be carried out on Women with singleton pregnancies with Rh     isoimmunization who are scheduled to have intrauterine blood transfusion. Selected patients     will be monitored weekly from 18 weeks gestational age till 28 weeks of gestational age.      Venous and arterial Doppler indices:        1. Middle cerebral artery (MCA) peak systolic velocity (PSV)        2. Umbilical Artery Pulsitility Index (PI) and Resistant Index (RI)        3. Ductus venosus (DV) Doppler      Cardiac functions:        1. Global cardiac function evaluated by Modified Myocardial Performance Index (Mod-MPI)        2. Diastolic cardiac function evaluated by relationship between the maximal velocities of          the E and A waveforms of ventricular filling (E/A ratio)   "
8863|NCT03169894|"     This is a Phase 1b, open-label, dose-escalation, signal-finding, single center study. The     study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of     MDGN-002 in adults with moderate to severe, active Crohn's disease who have previously failed     anti-tumor necrosis factor alpha (anti-TNFα) treatment.   "
8864|NCT03169881|"     Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will     have improved neurocognitive outcome at 22-26 months compared to placebo   "
8865|NCT03169868|"     The purpose of this study is to evaluate the clinical utility of a decision support tool, the     Patient Medication Profile(TM), developed by Sano Informed Prescribing on medication     reconciliation and identification of drug-related problems in patients with serious mental     illness.   "
8866|NCT03169855|"     A) The main purposes of this study are (i) to develop a related virtual reality (VR)     environment in order to judge the nighttime driving ability under mesopic and under glare     conditions (ophthalmologically healthy subjects and patients with incipient to intermediate     cataract, i.e. opacities of the human lens, will participate in this study), (ii) to validate     the above-mentioned VR environment with respect to a related on-road driving scenario under     mesopic and glare conditions, (iii) to validate clinical photopic and mesopic contrast vision     tests and glare tests with respect to the prediction of nighttime driving ability, (iv) to     assess the test retest reliability of clinical photopic and mesopic contrast vision tests      B) Background:      An intact mesopic vision and a glare sensitivity within a normal range are essential     pre-requisites for safe driving at nighttime (DOG & BVA, 2011). Anderson & Holiday (1995)     have shown that (simulated) opacities of the refractive media (with only minor effects on     daytime visual acuity) induce a pronounced impairment of contrast sensitivity under nighttime     conditions. Especially under glare conditions by the headlights of traffic on the opposite     lane or by stationary street illumination, an impairment of the mesopic vision may cause     traffic hazards. The prevalence of impairments of the central visual acuity, the mesopic     vision and the glare sensitivity is significantly higher for subjects being involved in     nighttime traffic accidents (Lachenmayr, 1998). Furthermore, these impairments occur more     frequently in aged drivers and are, among others, related to an increase of age-related media     opacities (Aulhorn & Harms, 1970, Babizhayev, 2003). Due to the demographic change, the     relevance of nighttime driving ability is increasing in the next years since more and more     aged employees will participate at the motorized traffic at night.      The German Fahrerlaubnisverordnung (FEV i.e. driving license regulation) specifies pass/fail     criteria with regard to mesopic vision and glare sensitivity. The luminance level during     nighttime driving is usually between 0.01 and 1 cd/m^2, and therefore can be attributed to     the level of mesopic vision. However, over the last years, the attempt was made to introduce     photopic contrast sensitivity test to diagnose nighttime driving ability (i.e. testing of     contrast vision under daytime conditions without time consuming adaptation procedures).     Current research aims at investigating the relationship between contrast tests under various     luminance conditions (Wilhelm et al, 2013). It is questionable, whether photopic tests are at     all reliable predictors with regard to nighttime driving (Gramberg-Danielsen et al., 1984,     Hertenstein et al., Graefe´s Archive of Ophthalmology, 2016).   "
8867|NCT03169842|"     This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous     pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA)     procedures.   "
8868|NCT03169829|"     The purpose of this proof-of-concept controlled-feeding study is to evaluate the impact of     plant-rich diets, with and without high-potassium fruits and vegetables, on phosphorus and     potassium homeostasis in hemodialysis (HD) patients.   "
8869|NCT03169816|"     This study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into     our program of outpatient detoxification and naltrexone induction followed by a     relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible     participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or     placebo (N = 20) with weekly therapy.   "
8887|NCT03169582|"     The main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal     cord injury erectile dysfunction. The study has the characteristics of a non- inferiority,     randomized, crossover, open clinical trial. The principal variable is the IIEF-EF (Erectile     Function Domain questionnaire of the International Index of Erectile Function IIEF).      This is an interventional study   "
9862|NCT03157024|"     This is a single blind randomised controlled trial involving healthy volunteers to determine     feasibility and blinding property of two types of sham press needles.   "
8877|NCT03169712|"     Sexual assault victims (SAV) have an elevated risk of developing posttraumatic stress     disorder (PTSD). Trauma-focused cognitive-behavioural therapy (CBT) is an effective     first-line treatment for this pathology. However, although sleep disturbances are a common     complaint in SAV with PTSD, trauma-focused CBT does not directly address this symptom.     Posttraumatic nightmares are widespread among SAV. Trauma-related sleep disturbances are     associated with significant impairment in general functioning and quality of life (mental and     physical health), and contribute to the maintenance of PTSD symptoms. This study evaluates     the efficacy of sequential nightmare therapy (imagery rehearsal therapy; IRT) and     trauma-focused CBT, in comparison to CBT alone. Forty-two SAV suffering from PTSD and sleep     difficulties were recruited and randomly assigned to the experimental (IRT+CBT) or control     condition (waiting period followed by CBT alone). Participants were administered a clinical     interview and a series of questionnaires assessing PTSD symptoms, general functioning and     quality of life.   "
8878|NCT03169699|"     To develop and validate a library of cough spectrum from a target of 1000 cough acoustics.     Coughs arising from upper respiratory infection, lower chest infections, asthma, allergic     conditions are included in the study. Cough acoustic in absence of respiratory disease is     also included.      This is a prospective observation cohort study recruiting children below the age of 16 years     old in 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) Well     patients without active coughing.   "
8879|NCT03169686|"     This proposed 18-month (July 01, 2017 to December 31, 2018) project is to assess whether     WeChat based, Interprofessional team support interventions ('WeChat WeQuit') will be     effective at helping people in China who smoke, to quit.   "
8880|NCT03169673|"     Healthy volunteers aged 18-75 will undergo hyperpolarized 3-Helium MRI and pulmonary function     testing for the development of tools to assess image signal to noise and reproducibility of     spin-density and diffusion-weighted imaging.   "
8881|NCT03169660|"     The prognosis of exudative age-related macular degeneration (AMD) accompanied by submacular     hemorrhage is generally poor. A recently developed anti-VEGF agent eyeliaTM is also a useful     treatment option for exudative AMD. However, one major limitation of VIEW study was that lack     of data regarding eyes with submacular hemorrhage. The purpose of the present study was to     evaluate the efficacy of Eylea in submacular hemorrhage secondary to exudative AMD.   "
8882|NCT03169647|"     Metacognition, in-the-moment awareness of performance while engaging in cognitive tasks, is     negatively affected by traumatic brain injury (TBI). Metacognitive deficits can greatly     reduce quality of life for individuals with TBI as functioning in this domain has been     closely linked with successful independent living and community re-integration.     Problematically, there are currently no empirically validated treatment options that address     metacognitive deficits after TBI. Recent research in healthy samples demonstrates that     specific listening interventions may alter neural activation in brain works associated with     metacognition and can improve metacognitive functioning; however, it remains unknown if these     effects generalize to individuals with TBI. Thus, the objective of the proposed study is to     use a double-blind, placebo controlled randomized clinical trial to determine the efficacy of     applying a specific listening intervention to improve metacognition after TBI and to employ     functional magnetic resonance imaging (fMRI) to document the neural mechanisms by which the     intervention operates.   "
8883|NCT03169634|"     Lay Person's Summary:      Knee replacement surgery has been successfully carried out for many years. However, in time,     some knee replacements will fail-usually either because of wear or loosening of the     replacement parts. This may mean the patient has to undergo further surgery-this is known as     revision total knee replacement (rTKR). This revision surgery is often more complex than the     original operation and presents the operating surgeon with several technical challenges. Of     particular concern, is that when the old knee replacement is removed, a large cavity can be     left in the bone. The new knee replacement has to be placed into this, but it is essential     that it is immediately stable and secure. The large cavity has to be somehow either filled in     or bypassed to ensure the new knee replacement is secure enough for early weight-bearing and     long term survival.      Different techniques have been used for many years to overcome this problem. Firstly, it may     be possible to simply cement another knee replacement into the cavity- probably needing more     cement than was previously used.      An alternative option to this is use a device called a cone which sits into the bony cavity     created by removing the original knee replacement, and a new knee replacement can be cemented     into this.      Bone grows onto the cone to ensure its stability. The new knee replacement can have either     short stemmed components like the original Total Knee Replacement (TKR), or long stemmed     components.      All of these types of rTKR are presently in use throughout the United Kingdom (UK). At this     point in time, no-one knows which type is best. The research team are planning to run this     study to see if it is possible to identify which type of rTKR gives the best outcome for     patients. The research team will examine the results in different ways including     questionnaires to measure how well the patients feel their knee is performing, specific tests     to measure knee function, and by using x-rays and scans.      The investigators will identify patients suitable for inclusion in the study from their     medical notes, x-rays and scans. If patients consent to be in the study, the research team     will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee     replacement only, cone with short stemmed components or cone with long stemmed components)     and monitor their progress for 5 years after the operation.      The investigators will identify patients suitable for inclusion in the study from their     medical notes, x-rays and scans. If patients consent to be in the study, the investigators     will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee     replacement only, cone with short stemmed components or cone with long stemmed components)     and monitor their progress for 5 years after the operation.      A preliminary analysis of the data generated by the study will be carried out 2.5 years after     recruitment of the 1st participant to assess compliance with the study protocol.   "
8893|NCT03169504|"     This study aims to compare the efficacy of three therapies for chronic obstructive pulmonary     disease (COPD) patients: one, conventional drug based on Global Initiative for Chronic     Obstructive Lung Disease (GOLD) 2017 and Chinese Medical Association Guidelines; another,     acupuncture, an important part of traditional Chinese Medicine; and finally, the combination     of conventional drug and acupuncture, and then determine which therapy is the most suitable     for patients with COPD.   "
8963|NCT03168594|"     The study will be conducted to compare the safety and efficacy of irinotecan combined with     cisplatin (IP regimen) and etoposide combined with cisplatin (EP regimen) in advanced or     metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.      In this prospective randomized phase II study, the investigators aim to compare the survival     benefit as well as the safety for irinotecan combined with cisplatin (IP regimen) versus     etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal     pancreatic and esophageal neuroendocrine carcinoma.   "
35196|NCT02825095|"     Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in     treatment of patients with malignant pleural effusion   "
8884|NCT03169621|"     Chronic endometritis (CE) is a persistent inflammation of the endometrial lining caused by     the infection of the uterine cavity mainly by bacterial pathogens. It is known that CE can     produce implantation failure, recurrent abortion and preterm labor. The study hypothesis is     that patients who have repeated implantation failures (RIF) despite transferring good quality     and normal embryos, diagnosed by preimplantation Genetic Diagnosis (PGD), into a receptive     endometrium, diagnosed by Endometrial Receptivity Analysis (ERA), may present asymptomatic     CE, being the altered endometrium the main cause of these implantation failures.      The current diagnosis of CE is the microbiological culture of endometrial biopsy samples.     Alternatively, examination of the uterine cavity by hysteroscopy is effective at 93.4%.     However, both methods have limitations, such as the time needed to obtain the diagnosis, the     economic cost of the tests, the possibility of detecting microorganisms in culture etc. For     these reasons, the developing of a simple, fast, cheap and minimally invasive diagnostic tool     for CE patients subjected to IVF treatments is expected. It would be very useful in order to     establish a specific treatment and improve pregnancy rates in infertile patients. For this     reason, the bacterial DNA present in the endometrial fluid samples will be obtained and the     identification of the causative pathogens of CE will be done by sequencing (NGS) and/or     quantitative PCR with specific oligonucleotides for the most common bacteria causing CE. The     validation of this new method will be performed by comparison with the microbiological     diagnosis of those same patients.   "
8885|NCT03169608|"     Characterization of the perioperative autonomic nervous system state, cardiovascular and     cerebrovascular control and microcirculation in order to predict postoperative atrial     fibrillation and acute kidney injury in patients undergoing coronary artery bypass graft     surgery   "
8888|NCT03169569|"     Endoscopic submucosal dissection (ESD) for superficial gastric neoplasm is minimally invasive     and achieves curative resection with an acceptable rate of adverse events. Although the     safety of ESD has been demonstrated, the procedure is associated with a substantial risk of     adverse events, including bleeding, perforation, and stricture.      Post-ESD bleeding is the most frequent adverse events and the incidence of post-ESD bleeding     in previous studies ranges from 1.8% to 15.6%. Several studies identified that antithrombotic     agents and large resection size were strong risk factors for post-ESD bleeding. Moreover, the     incidence of bleeding in high-risk patients has been reported to be as high as 61.5%,     depending on the definition of high-risk patients. The number of patients at high risk for     post-ESD bleeding is increasing worldwide. In addition, as the indications for ESD have been     expanding, more patients with large lesions undergo ESD. Therefore, it is important to     prevent post-ESD bleeding in high-risk patients.      Although several previous studies have attempted to prevent post-ESD bleeding using surgical     material, there is no definite prophylactic treatment to prevent re-bleeding after ESD. To     date, coagulation of remnant vessels on the post-resection ulcer surface and administration     of a proton pump inhibitor (PPI) after ESD are practical methods to prevent post-ESD     bleeding.      Polysaccharide hemostatic powder (Endo-Clot™) is a new topical hemostatic method recently     used for non-variceal upper gastrointestinal bleeding. This study aimed to identify the     efficacy of hemostatic powder in preventing post-ESD bleeding in high-risk patients. This is     a multicenter, prospective, randomized study.   "
8889|NCT03169556|"     Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is     a widely used equipment in cervical immobilized patients. However, a lightwand, which is used     blind, is difficult to make midline positioning and can increase airway complications and     hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through     camera, however, it requires cervical movement. Therefore, investigator hypothesized that the     combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of     intubation compared to the use of lightwand alone in cervical immobilized patients.   "
8890|NCT03169543|"     From 40 to 60% of patients with depression experience a rapid and significant improvement of     mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect     have not been elucidated. Recent advances in functional neuroimaging have provided new     opportunities to investigate state changes in regional brain function, along with a better     understanding of the neural networks affected by depression and SD. Here we propose to study     a group of N=48 antidepressant-free male and female patients with current depression symptom     and N=12 healthy controls with no history of mood disorders before and after SD to provide     mechanistic insight into the neural substrates underlying the antidepressant effects of SD.     We hypothesize that SD-induced concurrent functional activity and connectivity changes in     multiple brain networks related to different depressive symptom dimensions including emotion     regulation, attention, arousal, self-referential, and reward processing will underlie the     rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain     imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing     data will be acquired at baseline after normal sleep, during one night of total SD, and after     one night of recovery sleep using a 5-day in laboratory protocol during which subjects will     be continuously monitored by trained staff.   "
8891|NCT03169530|"     The Moderate Alcohol and Cardiovascular Health Trial (MACH15) is a multicenter, worldwide,     randomized clinical trial of ~15 gm of alcohol daily versus abstention, using a balanced     parallel design and single-blind assessment of all outcomes among approximately 7,800     participants aged 50 years and older with advanced cardiovascular risk. Intervention will     average 6 years in duration with a common close-out date. Following recruitment and     pre-screening, participants will attend a screening visit followed by a two-week abstention     washout period, a baseline visit and randomization, and subsequent visits at 3 months, 6     months, 12 months, and then annually until close-out.   "
8892|NCT03169517|"     Laser speckle contrast imaging (LSCI) allows real-time, non-invasive, quantitative     measurements of regional blood flow. The aim of this prospective observational study was to     evaluate the blood flow changes by LSCI after peripheral nerve block and determine whether     this novel optical technique can be used as a reliable indicator of successful blocks.   "
9028|NCT03167736|"     The purpose of this research is to compare two different approaches for treating patients     with lumbar spinal stenosis: electric dry needling and thrust manipulation versus     impairment-based manual therapy, stretching, strengthening and electrothermal modalities.     Physical therapists commonly use all of these techniques to treat lumbar spinal stenosis.     This study is attempting to find out if one treatment strategy is more effective than the     other.   "
8894|NCT03169491|"     Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe     complications, and its first line of treatment (adenotonsillectomy) has risk of     complications. Even though the use of presurgical CPAP seems logical due to its effects in     adults, it must be studied in children due to the different physiopathology and adherence.     One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the     anatomical site of obstruction. The post-surgical anatomical changes could correlate with a     persistent OSAS, which would be helpful in selecting those patients who require a post     surgical sleep study. The main goal of the study is to cuantify the changes in the     oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after     adentonsillectomy in children.   "
8905|NCT03169348|"     Autoimmune thrombocytopenic purpura is an immunological disorder characterized by increased     platelet destruction due to presence of anti-platelet antibodies. Hepatitis C virus     infection, which is one of the most common chronic viral infections worldwide, may cause     secondary chronic immune thrombocytopenic purpura. It seemed to play a pathogenic role in     autoimmune thrombocytopenic purpura. Moreover, the successful response (negative hepatitis C     virus - ribonucleic acid) to tapered steroids and antiviral therapy was useful to revert     thrombocytopenia   "
8939|NCT03168906|"     This is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm,     parallel-group efficacy and safety study of NEOD001 as a single agent administered     intravenously in adults with AL amyloidosis who have a maintained hematologic response to     their most recent treatment for AL amyloidosis (e.g., chemotherapy, autologous stem cell     transplant [ASCT]) and have persistent renal dysfunction.   "
8895|NCT03169478|"     Transcervical resection of submucous myomas (TCRM) is nowadays considered necessary if it is     associated with infertility or miscarriage or menorrhagia. Nevertheless, one possible risk of     hysteroscopic myomectomy is the formation of intrauterine adhesion (IUA) at the site of     resection. The development of IUA arising from trauma to the basalis layer of the endometrium     during hysteroscopy can result in infertility, recurrent miscarriages, amenorrhea,     dysmenorrhea, or abnormal placentation.      Several measures have been proposed in an effort to decrease the formation of post-surgical     intrauterine adhesions. Additionally, physical barriers such as balloon catheters or     intrauterine devices have been used in the postoperative period. Despite years of studies     evaluating prevention strategies for intrauterine adhesion formation after operative     hysteroscopy, it is still unclear which strategy is most effective because there has never     been any formal properly powered randomized, control trial to examine the efficacy of the     various methods used to prevent adhesion reformation.      In this prospective, randomized, controlled study, the investigators wish to examine the     efficacy of intrauterine balloon dilatation therapy in the early postoperative period in     preventing adhesion formation after transcervical resection of submucous myomas.   "
8896|NCT03169465|"     Patients with posterior calcaneal deformity may presented by many clinical data associated     with retrocalcaneal bursitis which occurs due to the deformity this clinical complaining     include pain and swelling in the back of the heel.      Many treatment choices available of this deformity with low level of response to conservative     treatment which includes medical treatment , physiotherapy and corticosteroids injection.     surgical treatment in cases of HAGLUND deformity is the treatment of choice including either     endoscopic or open surgical approach for this deformity .   "
8897|NCT03169452|"     Noninvasive ventilation is increasingly used method of respiratory management in both the     emergency room and critical care. Noninvasive ventilation delivers mechanically assisted     breaths without the placement of an artificial airway and has become an important mechanism     of ventilator support inside and outside the intensive care unit.      Noninvasive ventilation is further subdivided into negative pressure ventilation which is the     iron lung, first used in 1928 and the Hayek oscillator, is a more recently designed to     provide negative pressure during inspiration and positive pressure during expiration.     Noninvasive positive pressure ventilation can be used as continuous positive airway pressure     or bi-level positive airway pressure.   "
8898|NCT03169439|"     Irreversible electroporation (IRE) is a novel non-thermal ablation modality with promise for     revolutionizing the treatment for local solid tumors.      With the growing demand for alternative and less invasive treatments for localized tumors,     the investigators have seen the development and investigation of several tissue ablation     modalities, including radiofrequency ablation (RFA), microwave ablation, and cryoablation.     Although these modalities have been efficacious, they have some disadvantages owing to their     reliance on thermal energy for creating cell death.   "
8899|NCT03169426|"     Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion     injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker,     commonly used cardiovascular medication in patients with cardiac diseases such as     hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has     not been well documented. The purpose of the study is to investigate the effect of     beta-blocker on remote ischemic conditioning in healthy volunteers.   "
8900|NCT03169413|"     Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia     resulting from defects in insulin secretion, insulin action, or both.      According to American Diabetes Association diabetes can be classified into the following     general categories: Type one diabetes (due to beta cell destruction, usually leading to     absolute insulin deficiency), Type two diabetes (due to a progressive insulin secretory     defect on the background of insulin resistance), Gestational diabetes mellitus and specific     types of diabetes due to other causes, example monogenic diabetes syndromes (such as neonatal     diabetes and maturity-onset diabetes of the young, diseases of the exocrine pancreas, and     drug induced diabetes.   "
8901|NCT03169400|"     The project will be structured in 3 main parts:        1. Effect of sera of ESRD patients on HD using Theranova dialyzer on high-Pi induced          vascular calcification in an in vitro model of rat VSMCs.        2. Effect of sera of ESRD patients on HD using Theranova dialyzer on oxidative stress          pathways in an in vitro model of rat VSMCs vascular calcification.        3. Study of RNA sequencing, transcriptome analysis gene expression of time course high-P          challenged VSMCs studying the effect of sera of ESRD patients on HD using Theranova          dialyzer   "
9455|NCT03162302|"     The objective of this study is to develop and evaluate novel magnetic resonance imaging (MRI)     protocols for studying the structure and function of the human body using 1.5Tesla and     3.0Tesla MRI scanners with or without the use of an MRI contrast agent.   "
8902|NCT03169387|"     Introduction: Cardiovascular diseases are the leading cause of death in the world, thus,     rehabilitation programs are essential to improve symptoms and reduce mortality. Virtual     reality presents itself as a new alternative of therapeutic resource, stimulating the     practice of physical activity through interaction between man and machine, based on the use     of games and virtual environments. Objective: To compare the body composition of individuals     with cardiovascular diseases submitted to conventional cardiac or virtual reality     rehabilitation. Methods: Twenty-four individuals with cardiovascular diseases, divided into a     conventional rehabilitation group (GRC) or virtual reality rehabilitation group (GRV), will     be evaluated, and undergo a rehabilitation program for a period of 8 weeks, with two weekly     sessions lasting 60 minutes. For the GRV training, the Xbox 360® from Microsoft with Kinect™     will be used with the games YourShape™ (Fitness Evolved) and Dance Central 3™. For the GRC     training, treadmills (embreex) will be used to perform the aerobic training and free weights     and weight training equipment to perform the resistance training. Food frequency will be     evaluated by means of the Food Frequency Questionnaire, food consumption by the 24-hour food     recall, body composition by bioimpedance, and functional capacity by the six-minute walk     test. For analysis of data normality the Shapiro Wilk test will be applied. For paired     analysis, the Student's T test will be performed in case of normal distribution or the     Wilcoxon test for variables that do not follow Gaussian distribution. The intergroup     comparisons will be analyzed through absolute variation before and after the interventions     and the unpaired Student's T test or Mann Whitney test applied according to the normality of     the data. The level of significance adopted will be 5%.   "
8903|NCT03169374|"     The purpose of this study is to investigate the safety and feasibility of virtual reality for     anxiety treatment in mechanically ventilated patients.   "
8904|NCT03169361|"     The purpose of this study is to evaluate the safety of NINLARO in participants with     relapsed/refractory multiple myeloma in daily clinical practice.   "
8915|NCT03169218|"     The purpose of this study was to evaluate pain and function after mirror therapy as well as     level of catastrophism in bilateral carpal tunnel syndrome patients   "
10962|NCT03142399|"     The aim of this study is evaluate the effect of whey protein supplementation on muscle mass     preservation, improvement of strength and quality of life, and inflammatory parameters in     patients with heart failure NYHA I or II followed by a cardiac rehabilitation program.   "
8906|NCT03169335|"     The objective of this study is to assess the similarity between QL1101 and Avastin®     respectively combined with chemotherapy in terms of efficacy and safety in patients with     non-squamous non-small cell lung cancer. The study intends to include first-line patients     with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic     chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and     dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small     cell lung cancer.   "
8907|NCT03169322|"     Studies reveal association between dry conditions and decreased healing in wounds or any     treatment. From these studies, it can be hypothesized that healing in mouth breathers after     scaling and root planing in terms of bleeding on probing, gingival index, plaque Index,     clinical attachment level, probing depth may not show as much improvement as in case of nose     breathers. No study has been conducted till date to find effect of scaling and root planing     in periodontitis patients among mouth breathers and nose breathers.   "
8908|NCT03169309|"     Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT); is an     auditory-neurophysiologic technique which uses auditory tones (often embedded in music,     nature sounds or white noise) dichotically via stereo headphones to manipulate brainwave     activity in turn affecting the listener's mental, physical and/or emotional state. Although     this technology is widely marketed to the general public and can be found free in on the     internet, only a hand full of scientific studies have shown its efficacy. This study is a     follow-on study to the Sound Mind Warrior (SMW) Study (ClinicalTrials.gov [NCT02328690])     conducted 2012-2015 which assessed the efficacy of the technology (in the theta brainwave     frequency) on the cardiovascular stress response in a group of service members with complaint     of chronic stress. This study will now assess BET (in the delta brainwave frequency) on     sleep quality in a population of military healthcare beneficiaries with complaint of poor     sleep quality.   "
8909|NCT03169296|"     Myelodysplastic syndrome (MDS) is a group of clonal haematopoietic stem cell disorders     characterized by ineffective haematopoiesis leading to cytopenia, with a significant risk of     progression to acute myeloid leukaemia (AML). Progression to AML and resistance to     hypomethylating agents (HMA) are important unmet clinical needs. The pathophysiology of MDS     and its progression to AML involve cytogenetic, genetic and epigenetic aberrations, and hence     better understanding of the molecular landscape of MDS has important clinical implications.     Also, future treatment strategies for MDS may involve exploitation of genetic information in     designing more effective therapy encompassing single agents or combinatorial approaches.      The proposed cohort study aims to establish a registry of clinical and genomic registry of     MDS and secondary AML in Asian patients, which allows the establishment of the mutational     profile of patients and prognostic model for survival, as well as exploration of treatment     strategies and prediction for treatment response.   "
8910|NCT03169283|"     This project will assess the effects of the macro-nutrient make-up of morning food intake on     cognitive performance using visual analog scale (VAS) measures, behavioral tests, and     advanced high-density electrophysiological techniques (256-channel recordings). Two     Isocaloric cereal products will be tested and compared to determine if measures of cognitive     performance as well as satiety will change after consumption.   "
8922|NCT03169127|"     The present clinical trial randomized will be to assess the link between the different     haplotypes of CYP2C8 and CYP2C9 genes and the clinical efficacy of ibuprofen after lower     third molar extractions. Onset, duration of postoperative analgesia, duration of anesthetic     action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth     opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 200     healthy volunteers underwent removal of one lower third molar, under local anesthesia with     articaine 4% (1:200,000 adrenaline) will be genotyped and phenotyped for these genes and     their postoperative records with all data collected will be compared with the haplotypes     found in the Brazilian population.   "
9012|NCT03167944|"     Breast cancer is one of the most common cancer among women nowadays. There are lots of     modality of treatment and one of them is Mastectomy. We found out that seroma is one of the     disturbing postoperative complications after mastectomy. In our study we want to compare the     outcome between using the conventional electrocautery and the low thermal tissue dissection.     We expected that the serum production should be lower in cases using low thermal system     electrosurgery system.   "
35197|NCT02825082|"     EMERGENCY GENERAL SURGERY IN GERIATRIC PATIENTS: EPIDEMIOLOGY, AND EVALUATION OF FACTORS     AFFECTING MORBIDITY AND MORTALITY   "
8911|NCT03169270|"     The current protocol is developed in the context of a large Research and Innovation (R&I)     program aiming the promotion of daily life physical activity in chronic patients registered     at clinicaltrials.gov (NCT02976064) and approved by the ethical committee of the Hospital     Clinic de Barcelona (HCB/2016/0883). The project is partly supported by the Smart Innovation     Strategies promoted by the EU Commission (COMRDI15-1-0016). Specifically, the protocol uses     retrospective information collected between 2005-2008 as part of the EU project Biobridge     (LSHG-CT-2006-037939).      The aims of the current analysis of the retrospective information are 1) to assess     training-induced changes in muscle oxygen saturation (StO2) assessed by near-infrared     spectroscopy (NIRS) during constant-work rate cycling exercise (CWRE) as a useful marker of     the effects of training at limb muscle level in patients with chronic obstructive pulmonary     disease (COPD), and 2) to further explore underlying mechanisms of skeletal muscle     dysfunction as a characteristic systemic effect of COPD, potentially modifiable with     preventive interventions as endurance muscle training.      Methods: Incremental exercise (VO2 peak) and CWRE at 70% baseline peak work rate, before and     after 8-week of endurance exercise training, were done in healthy sedentary subjects and COPD     patients. NIRS was used to assess StO2 in the left vastus internus during the CWRE (before     an after training program) (objective 1); and blood samples and muscle biopsies of the     quadriceps were obtained at rest (before an after training program) (objective 2).   "
8912|NCT03169257|"     Background Childhood obesity has been related to an impaired cardiovascular structure and     function. Aims of this study will be to evaluate early cardiovascular abnormalities in a     large population of obese children and adolescents compared with a normal weight counterpart,     to investigate the potential association with insulin resistance (IR), serum uric acid (sUA),     metabolic syndrome (MetS), plasmatic markers of inflammation and oxidative stress and     adipokines, to evaluate changes in cardiovascular dysfunction after 6 and 12 months of a     behavioral treatment (isocaloric Mediterranean balanced diet plus daily aerobic physical     activity).      Subjects and methods This was a single-center case-control study. Eighty obese (OB) subjects     (6-16 years) and 20 normal weight (NW) matched controls were consecutively recruited. In the     whole population we will perform an anthropometric and a cardiovascular assessment. OB     patients will also undergo an OGTT and biochemical evaluations. In the OB group, all these     evaluations will be performed at baseline and after 6 (T6) and 12 months (T12) of diet plus     aerobic training.   "
8913|NCT03169244|"     The present proposal is an innovative and translational clinical trial derived from exciting     preclinical findings to test the hypothesis that treatment with the melanocortin activator     bupropion can reduce binge drinking in humans. Furthermore, pilot data on moderating effects     of coexisting nicotine use on the efficacy of bupropion for binge drinking population will be     obtained. Evidence for an efficacy signal with good tolerability with this FDA approved     medication would form the foundation to conduct a well-powered Phase II b trial. The     development of an effective pharmacotherapy for binge drinking would be a significant     clinical advance.   "
8914|NCT03169231|"     This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b     study.   "
8917|NCT03169192|"     The study will be conducted at Assiut university children hospital and it will include     patients with history of repeated fractures due to mild or irrelevant trauma.      Diagnosis will be established by biochemical tests, bone survey to exclude secondary causes     followed by Dual Energy absorbiometry scan to detect bone density of selected cases then     confirm our diagnosis by detection of gene mutations of Osteogenesis imperfecta during one     and half year duration with starting zoledronic acid therapy during this duration.   "
8918|NCT03169179|"     Policing is an increasingly sedentary occupation and high levels of physical and     psychological morbidities are reported by officers and staff. Wearable fitness technology may     be an effective intervention to promote physical activity and improve health.      This study aims to assess the effectiveness and feasibility of introducing wearable fitness     technology (Fitbit™ activity monitors linked to the 'Bupa Boost' smartphone app) as a     motivator for increasing physical activity within the police force. Additional aims are to     explore which motivational strategies (e.g. individual goal-setting vs. social competitions)     are most effective and for which groups of staff, and to assess the impact of the     intervention on health and wellbeing, stress, sickness absence and self-perceived     productivity.      A single-group, before and after, exploratory trial will be conducted. Approximately 180     police officers and staff from two sites (Plymouth Basic Command Unit and North Dorset) will     be recruited to take part. Participants will use the technology for 12 weeks initially     followed by a further five months of optional use. A combination of questionnaire surveys,     interviews and analysis of staff absence records will be used.      Data will be collected pre-intervention, mid-intervention (6 weeks), post-intervention (12     weeks) and follow-up (8 months). Primary outcomes are change in objectively recorded step     count, self-reported physical activity and sedentary time. Secondary outcomes include general     health and wellbeing, perceived stress and productivity, sickness absence, engagement with     the intervention and perceived usability and usefulness.      This study will add to our understanding of the effectiveness and acceptability of mobile     fitness technology in a specific workplace setting, and inform a larger trial within the     police force.   "
8919|NCT03169166|"     This is a prospective comparative randomized controlled trial investigating the effect of two     GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women     undergoing assisted reproductive technology.   "
8920|NCT03169153|"     The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to     ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake)     after 30 days of wear by high lipid depositors.   "
8921|NCT03169140|"     The purpose of this study is to compare the effect of a combination of separate therapies of     Biofreeze® and TheraBand Kinesiology Tape to advice on acute pain, disability and fear     avoidance among low back patients over a 1-week period of time.   "
8952|NCT03168737|"     This goal of this clinical research study is to learn the best time to have a PET-CT scan     after receiving (18)F-fluoroazomycin arabinoside ([18F]FAZA).      During certain types of scans (like PET-CT scans), an imaging agent is injected into your     bloodstream to help certain parts of your body be more clearly seen during the scan.     [18F]FAZA is a new imaging agent designed to show how much oxygen is in a tumor during a     PET-CT scan.   "
8923|NCT03169114|"     The RIPASA score is a Clinical Prediction Rule (CPR) for the diagnosis of acute appendicitis.     Since its inception in 2009, the RIPASA score has been validated in various population in     healthcare institutions around the world and reported significantly higher sensitivity and     specificity when compared to Alvarado score. RIPASA score ranges from 3 to 16.5 with those     having a score of less than 7 having a low probability of acute appendicitis and those with a     score of 7.5 having a high probability of acute appendicitis.      There has been a trend in the past decade on non-operative management of early-uncomplicated     acute appendicitis (EuAA) with antibiotic therapy. This antibiotic non-operative management     strategy (AMS) has been reported to work in children, thus avoiding unnecessary emergency     operation. In adults presenting with early-uncomplicated acute appendicitis, this management     pathway is still uncertain and most randomized controlled trials (RCT) and meta-analysis have     not been able to show significant benefit of AMS over surgery management strategy (SMS),     partly due to variable treatment efficacy, high recurrence rate within a year and a lack of     agreement of whom would constitute a group of EuAA.      The working hypothesis of this study is that RIPASA score as a Clinical Prediction Rule, can     determine a group of patients with a diagnosis of EuAA, based on the range of scores (RIPASA     score 7.5 - 11.5), who will benefit from an AMS rather than SMS, leading to improve patients'     outcomes through a significant reduction in negative appendicectomy rate, shorter length of     hospital stay, reduce post-operative complications and changing physician behavior in     managing this group of patients to an AMS rather than SMS and ultimately financial cost     savings.      The primary specific aim of this study is to compare AMS with SMS in patients with EuAA in a     prospective non-inferiority RCT. Secondary specific aims are to determine the range of RIPASA     score that can define a group of patients with EuAA, step 3 validation of RIPASA score as a     valid CPR and improve patient outcomes in terms of reducing unnecessary negative     appendicectomy rate, hospital stay and complications arising from such surgery, and     ultimately financial cost savings.   "
8924|NCT03169101|"     This study tests whether withdrawal-related cognitive deficits increase smoking relapse among     HIV-infected (HIV+) vs. HIV-uninfected smokers (HIV-). Adult smokers (N=300; 150 HIV+, 150     HIV-) will complete 2 sessions to assess cognition (24h abstinence vs. smoking-as-usual;     order counterbalanced; weeks 0-2). Subjects will then receive smoking cessation counseling     and open label transdermal nicotine (weeks 3-12). Outcomes are: 1) cognition; and 2)     abstinence rates at the end-of-treatment.   "
8925|NCT03169088|"     Unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge     financial burden in EU healthcare systems. Unfortunately, the communication of Public Health     failed to influence consumer to change their habits.      In this study, the aim is to evaluate the impact of a regular monitoring during 1 year on     wellbeing and dietary habits in healthy volunteers.      This study follows the pilot study cook to health and is intended to confirm the results     obtained by the tools used in C2H, in a larger population (25-50 years)   "
8926|NCT03169075|"     This phase II-III study will randomize (2:1) patients starting first-line OTT for metastatic     cancer between an individualized SPEP supervised by a personal coach, and recommended     physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic     chemotherapy, ECOG PS ≤2, controlled pain (VAS <3/10), and life expectancy ≥3 months.   "
8927|NCT03169062|"     The purpose of this study is to propose a new method for evaluating coronary artery calcium     scores (CACS) in individuals with coronary artery disease.   "
8928|NCT03169049|"     The purpose of this study is to determine whether the transcutaneous application of     unmodulated high frequency alternating currents could produce a quickly conduction block of     peripheral nerve.   "
8929|NCT03169036|"     Melanoma is the most dangerous skin cancer and is becoming commoner, largely due to increased     foreign holidays and use of sun-beds. Melanoma usually begins as a new or changing mole. If     it is picked-up quickly enough it can be removed in a simple operation and effectively cured.     GPs can do this operation and many are highly experienced and skilled in minor skin surgery.     However, guidelines written by hospital specialists insist that all patients who might have a     melanoma should not be treated by GPs, but should be referred to hospital. This contrasts     with Australia, where melanoma is commoner and initial treatment by GPs is standard practice.     This creates several potential problems. First, melanoma can be difficult to diagnose. Many     moles that do not look concerning based on checklists do turn out to be melanoma, and the     opposite frequently occurs too, moles that look worrying at initial examination are not     melanoma. Second, people are becoming more skin aware and GPs are checking moles much more     often. Sensibly many of these patients are being sent to hospital for a check, although most     will not have melanoma. Third, as a result hospital skin clinics and minor surgery lists are     becoming very busy and waiting times are ever increasing. Fourth, the many people who have a     melanoma that is not clinically obvious are waiting an increasingly long time to have it     diagnosed and treated in hospital, and this could actually mean that melanoma has more chance     to spread while they wait. The investigators conducted studies on 1200 people diagnosed with     a melanoma in Northeast Scotland between 1991 and 2008 and found that 20% of these people had     had their melanoma diagnosed and first treated by their GP. These patients were no more     likely to receive improper treatment than those that had been referred to hospital. Also     people who had had their melanoma cut out by a GP were no more likely to die from melanoma,     and they actually required less hospital visits afterward. This suggests that the guidelines     could be changed to allow GPs to treat suspicious moles. The investigators think this will be     better for patients and the NHS in the long-run. However, the investigators cannot recommend     changes to the guidelines on the basis of local research. For this reason, the investigators     wish to extend the study using data from 18,000 patients diagnosed with melanoma from across     Scotland. The results of this inclusive study will inform how the health service should deal     with the growing problem of suspicious moles in the future.   "
8930|NCT03169023|"     This proposal will pilot a weight management program for patients with endometrial cancer,     the cancer most associated with obesity. If successful, this pilot could be expanded to     include obese women with other gynecologic cancers (ovarian and cervical) and could be     expanded and adapted for use not only upon completion of treatment, but during chemotherapy     or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for     obese women as a practical cancer prevention strategy for obesity-associated cancers.   "
8931|NCT03169010|"     The knowledge on the rare type of pulmonary hypertension which can not be explained by left     heart disease, respiratory disease or congenital heart disease is very limited. Investigators     aim to setup a national registration study for the rare type of pulmonary hypertension, to     understand the natural history, survival, progression, genetic and environmental     contributions to disease.   "
8932|NCT03168997|"     The aim of this study is to investigate whether there will be any efficacy difference of     Memantine treatment in different cognitive severity AD patients stratified with BPSD   "
8933|NCT03168984|"     The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of     UCB0942 in Japanese and Caucasian subjects.   "
8934|NCT03168971|"     The purpose of this study is to examine the preliminary efficacy of a telephone-administered     cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older)     with cancer and their primary informal caregiver. This study will examine the impact of the     intervention on patient and caregiver anxiety (primary outcome) and depression, distress, and     quality of life (secondary outcomes) relative to a usual care control condition.   "
8962|NCT03168607|"     Currently, there is no standard second line treatment for patients with neuroendocrine     carcinoma. Irinotecan monotherapy or combination regimen has shown promising in previous     study. The study was designed to confirm thet FOLFIRI regimen can be used as a second-line     regimen for patients with advanced or metastatic neuroendocrine carcinoma who have progressed     after first-line chemotherapy with platinum based regimen.   "
8935|NCT03168958|"     Patients undergoing cardiac surgery often experience moderate to severe pain in the early     postoperative period. A number of methods have been used to help control pain after surgery;     however, each of these techniques adds additional costs and risks. A simple and effective way     to decrease this pain is to administer a long-acting opioid in the operating room. Methadone     is a opioid that can produce analgesia (pain relief) that lasts up to 48 hours when given in     large doses (0.3 to 0.4 mg/kg). Previous studies have demonstrated that both pain and     requirements for analgesic medications are significantly reduced for up to three days after     surgery if methadone is given at induction (the start) of anesthesia. In the study that was     performed at Evanston Hospital, cardiac surgical patients who were given methadone also     appeared to feel better after surgery compared to those given a standard or typical     intraoperative opioid. The aim of this randomized clinical trial is to determine whether     overall quality of postoperative recovery can be enhanced if methadone is given in the     operating room. Quality of recovery will be determined by using a validated scoring system,     the QoR 40, which will be given to patients to complete on the first three days after     surgery.   "
8936|NCT03168945|"     TB kills most people with HIV in Africa. TB is out of control. Radically different approaches     to deal with the disease is therefor needed. It is known that intensified case finding works     in high HIV prevalence environments. However, the poor performance of conventional     diagnostics makes the strategy costly and unpalatable for policy makers. If it can be shown     that a package of new diagnostic technologies significantly enhances ease and speed of     diagnosis, and time to treatment initiation when using intensified case finding, this will     usher the way for further studies and policy adjustments to tackle TB. Thus, the work, if     found to be useful, could have major policy implications      The purpose of this study will be to determine the diagnostic yield, impact and feasibility     of community-based intensified TB case finding using symptom screening, point-of-care TB     testing (Xpert Omni), point-of-care HIV testing and CD4 count (Alere PIMA), if HIV-infected,     together with a clinic-based diagnostic package (sputum smear microscopy, MGIT sputum     culture, and digital chest radiograph). Additionally, the study will assess the     infectiousness of previously undiagnosed TB cases in the community using cough aerosol     sampling technology (CASS) and will determine the genomic, transcriptomic and lipidomic     profile of TB isolates from patients undergoing CASS sampling. The cost-effectiveness of     using a novel TB diagnostic platform (Xpert Omni) for intensified case finding compared to     conventional methods will also be evaluated.      ~6000 people will be screened to enrol 600 participants with suspected TB. It is expected     that using the GeneXpert® Omni POC mobile clinic of 2- to 3-person team of healthcare workers     in an inexpensive panel van will substantially reduce the time to treatment initiation, and     the proportion of individuals initiating and completing TB treatment. Investigators will also     review and follow up Household contacts of active TB participants.      As part of the study investigators will also contribute data and specimens to the RePORT     consortium (Regional Prospective Observational Research for Tuberculosis), that aims to     create a multinational bank with the primary objective of providing specimens and data to     RePORT consortia biomarker researchers and their collaborators over the next decade to     achieve a better understanding of the prognosis of TB disease; and the pathogenesis of     progression from TB exposure to disease.   "
8937|NCT03168932|"     Gyrogenesis is an ontogenic process that transforms the smooth (lissencephalic) cortex toward     its mature, convolved (gyrencephalic) state. A tortuous, branching and deepening pattern of     sulci and fissures outlines for a well-developed cortex.      The aim of this study is to find an algorithm that can detect the sulci in ultrasound images     of fetus' brain and measure the length of it. This algorithm can be used for research demands     like learning the development of the brain from embryo stages until the birth of the baby   "
8938|NCT03168919|"     The overall goal of this study is to determine if quantitative imaging techniques can be used     to detect dynamic changes of morphology and different physiologic properties of the tumor     during and after completion of radiation treatment and to predict site and time of radiation.   "
8940|NCT03168893|"     Deep brain stimulacion (DBS) clinical study in the subcallosal cingulate (CSG) and accumbens     nucleus (NAc) for 8 patients with treatment-refractory, cronic and severe anorexia nervosa     (AN) patients. The main objective is to show efficacy and safety. Studies show that SSG and     NAc are strategical targets in the pathophysiology and the hypothetical surgical treatment in     AN patients. The patients distribution (4 patients in each target) it will made by the AN     type and the comorbidity associated, the reasons are: 1- It is well known the comorbidity     treatment imoportance in the AN evolution, 2- The two differentes types of AN have differents     clinical behaviour and prognosis, 3- Studies show efficacy in TOC and DM patients with NAc     DBS and in DM patients with CSG DBS. The main variable is BMI. After a 6 months stabilization     evaluation phase will be followed (only in patients that have increase 10% BMI) by a     double-bind, crossover phase, where patients will receive 3 months with stimulation turned on     and 3 month with turned off. All patients will have a 12 months follow up. The study     secondary objectives are to know the relation btween the stimulacion answer (increase 10%     BMI) and the differents variables, specially AN type, associated cormobidity, selected target     and preoperative MRI tractography study.   "
8941|NCT03168880|"     Triple-negative breast cancer is a subtype of breast cancer that is clinically negative for     expression of estrogen and progesterone receptors (ER/PR) and HER2 protein. It is     characterized by its unique molecular profile, aggressive behavior, distinct patterns of     metastasis, and lack of targeted therapies. Although not synonymous, the majority of     triple-negative breast cancers carry the basal-like molecular profile on gene expression     arrays.      Although sensitive to chemotherapy, early relapse is common and these cancers show a     predilection for visceral metastasis, including brain metastasis. Targeted agents, including     epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), and poly     (ADP-ribose) polymerase (PARP) inhibitors, are currently in clinical trials and hold promise     in the treatment of this aggressive disease.      Multiple independent data sets have revealed that the triple negative type of breast cancer     carries a poor prognosis. It is unclear whether the poor prognosis of triple negative breast     cancer is due to poor therapy options or inherent aggressiveness. Given their triple negative     receptor status, these tumors are not amenable to conventional targeted therapies for breast     cancer, such as endocrine therapy or trastuzumab, leaving only chemotherapy in the     therapeutic armamentarium.      Patients on metformin showed a 30-40% protection against all forms of cancer. Recent pilot     studies carried out using population registries raise the possibility that metformin may     reduce cancer risk and/or improve cancer prognosis. One showed an unexpectedly lower risk of     a cancer diagnosis among diabetics using metformin compared with a control group of diabetics     using other treatments ; another showed lower cancer-specific mortality among subjects with     diabetes using metformin compared with diabetics on other treatments. Metformin is a     biguanide known to be an insulin sensitizing agent which promotes reduced circulating insulin     and glucose levels in hyper-glycaemic and hyper-insulinaemic patients. Metformin activates     the AMP dependent kinase, attenuates insulin and IGF-1 stimulated proliferation in breast     cancer cells and a general decrease in protein synthesis in vitro. Western blot analysis     indicated that metformin stimulates AMPK phosphorylation in a dose-dependent manner. AMPK     activation is associated with decreased phosphorylation of mTOR and S6 kinase. While     metformin reduces breast carcinoma cell proliferation both in vitro and in vivo, the     activation of AMPK leads to significant VEGF production, angiogenesis and tumor progression.     This must be taken into consideration when it is applied in as a therapeutic regimen.   "
8942|NCT03168867|"     The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The     3Ms. The proposed study will use an effectiveness-implementation Hybrid 1 design. In this     design, the primary goal is to determine whether an intervention works in a real-world     setting, but the design also answers secondary questions such as the relationship between     treatment dose and treatment outcome and what factors affect the actual delivery of the     intervention in the clinics (staff burden, workflow interference etc).   "
8943|NCT03168854|"     This Phase 1 trial will include 16 subjects in Study Arms 1 and 2 who will receive the GAP3KO     vaccine administered by the bite of approximately 200 infected A. stephensi mosquitoes in a     controlled clinical environment and 12 CHMI infectivity controls (six for each of the two     CHMIs). The ten subjects in Arm 1 will each receive five vaccinations, with the first four     vaccinations given four weeks apart and the fifth vaccination given eight weeks after the     fourth vaccination, for a maximum cumulative dose of 1000 GAP3KO bites per subject and     scheduled vaccinations will be given to all Arm 1 subjects on the same day. The first CHMI     will be given at four weeks after the last vaccination for subjects in Study Arms 1 and 2 and     will include six infectivity controls. The second CHMI will be given 26 weeks (six months)     after the first CHMI and will include subjects in Study Arms 1 and 2 who did not have     documented malaria infection following the first CHMI and six new infectivity controls. To     allow the first and second CHMI administrations to be given concurrently to subjects in Study     Arms 1 and 2, subjects in Study Arm 2 will initiate the GAP3KO series on the day that Study     Arm 1 subjects receive their third vaccination. The second vaccination for Study Arm 2     subjects will be given four weeks later, on the day that Study Arm 1 subjects receive their     fourth vaccination, and both groups will receive their last vaccination eight weeks later.     Subjects will be observed for adverse events for at least 60 minutes after each GAP3KO     administration. Solicited local and systemic AEs will be recorded on a memory aid Subjects     will be monitored for possible breakthrough peripheral parasitemia . Positive tests will be     followed by repeat testing as soon as possible and with clinical safety labs.Four weeks after     the last GAP3KO administration, all subjects who completed the immunization phase (up to 16)     and a group of six malaria-naïve infectivity controls will be challenged on the same day with     wild-type P. falciparum NF54 sporozoites. On the day of challenge, subjects will receive five     infectious A. stephensi mosquito bites using standard CHMI procedures. Twenty-six weeks (six     months) after that challenge, all of the protected subjects in Arms 1 and 2 (up to 16) and     another six malaria-naïve infectivity controls will receive five infectious A. stephensi     mosquito bites on the same day using standard CHMI procedures. For subjects in Study Arms 1     and 2 with documented parasitemia after the first CHMI or who are discontinued for other     reasons after the first CHMI, and for the infectivity controls, additional follow up will     occur on Days 90 and 180 after their first CHMI. SAEs will be recorded from the day of CHMI     through the end of study follow up and clinical laboratory evaluations for safety will be     performed on Day 29 and as clinically indicated (all subjects) and, for subjects with     documented parasitemia, on the day malaria treatment is initiated and three days after     malaria treatment is initiated. The primary objectives are to: 1) assess the safety and     reactogenicity of candidate GAP3KO malaria vaccine when administered by the bite of     approximately 200 infected mosquitoes on a five dose schedule, with the first four     vaccinations given four weeks apart and the fifth vaccination given eight weeks after the     fourth vaccination, and on a three dose schedule, with the second vaccination given four     weeks after the first vaccination and the third vaccination given eight weeks after the     second vaccination, to healthy malaria-naïve adults aged 18 through 50 years , 2) confirm     attenuation of GAP3KO parasites by assessing the occurrence of breakthrough peripheral     parasitemia from the time of first GAP3KO administration through 28 days after last GAP3KO     administration.   "
8944|NCT03168841|"     Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic     subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of     subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the     efficacy and safety of both topical and oral antifungal treatment options for onychomycosis     in diabetic subjects. However, no study to date has specifically addressed the efficacy and     safety of efinaconazole among diabetic subjects.      The objective of this noncomparative, uncontrolled study is to determine the efficacy of     topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus.     Specific indicators to measure efficacy of treatment will be the mycological cure rate,     complete cure rate, and treatment success. Furthermore, an additional goal of the study is to     gain knowledge of safety in the setting of a cohort of diabetic subjects   "
8945|NCT03168828|"     The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery     system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO)     resulting from spinal cord injury (SCI).   "
8946|NCT03168815|"     Pneumonia is a lung infection. Fiberoptic bronchoscopy is a test to diagnose the type of lung     infection. While this procedure is being performed, a small amount of oxygen is delivered     into the nose (low flow nasal cannula). Occasionally during this procedure, the blood oxygen     of the patient may drop and an intervention such as increasing the oxygen flow, or placing     the patient on a breathing machine is required. An alternative device called 'Optiflow' can     provide high flow oxygen through nasal cannula, and is comfortable for patients. If Optiflow     is used during bronchoscopy, it may prevent the blood oxygen from dropping.   "
12529|NCT03121820|"     This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of     Memantinol® (JSC GEROPHARM, Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma     GmbH & Co. KGaA, Germany) 20 mg tablets in normal healthy subjects   "
8947|NCT03168802|"     This is a prospective, randomized, two-arm, phase II study.      The purpose of this study is:        -  To evaluate and compare the efficacy and safety of magnetic resonance-guided focused          ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint          osteoarthritis low back pain.        -  Determining the effect of the MRgFUS System and RFA for improving functional          disabilities and in reducing pain resulting from facet-joint osteoarthritis low back          pain. Efficacy will be determined by the level of pain relief (as measured by the          Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life          (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures          index questionnaire, COMI), pain interference with function (as measured by the Brief          Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the          EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS          and radiofrequency treatment.        -  Evaluate incidence and severity of adverse events associated with the MRgFUS system and          RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back          pain.   "
8948|NCT03168789|"     This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To     determine eligibility potential subjects will have resting blood pressures (BP) measured on 2     occasions. Pre-hypertensive individuals will be invited to participate in the study. After     informed consent is obtained, subjects will complete baseline visit consisting of a survey,     resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours,     collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer     (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining     4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days     ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout     the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.   "
8949|NCT03168776|"     The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA     Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the     XIENCE or Promus durable polymer coronary stents.      This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to     1632 subjects at up to 130 investigational sites in North America, Japan, and Europe.     Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2,     3, 4, and 5 years.   "
8950|NCT03168763|"     The goal of this research study is to learn about the effects of a doctor's characteristics     on participant's preference for a doctor. Researchers also want to learn about how a doctor's     characteristics affect participant's options about professionalism and compassion.   "
8951|NCT03168750|"     This prospective study will evaluate the hip function and quality of life of patients     operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The     results of this study will establish the performance of Masterloc femoral component (Medacta     International SA) and MPACT acetabular component (Medacta International SA), and provide a     general estimate of survivorship, clinical effectiveness and complications.   "
8953|NCT03168724|"     Goal Management Training (GMT) is a cognitive rehabilitation program targeting executive     dysfunction (problems with attention, reasoning, problem solving, planning, etc), which is a     central problem in HIV-associated neurocognitive disorder. It teaches self-management     principles, stress management and mindfulness, and trains participants in the use of several     strategies to reduce cognitive load in everyday tasks, and methods to cue attention to     maintain focus on specific tasks. GMT is a manualized protocol with set content conveyed     through a combination of slides and a workbook. Two-hour small group sessions are led, in     person, by a trained therapist once a week, for nine weeks. The small group sessions allow     participants to learn from each other, enhancing engagement. GMT has been shown to improve     cognitive function in a variety of neurological conditions, as well as in healthy older     people with cognitive concerns. These improvements have been shown to last at least 6 months     in some studies and are accompanied by changes in the brain networks underlying executive     function. GMT is thus a well-validated, high yield intervention with which to test the     potential of cognitive rehabilitation in older HIV+ people with cognitive concerns.      The researchers hypothesize that GMT will lead to improved cognitive function as assessed by     better performance on cognitive tests and reduced self-reported cognitive difficulties in     people with stable HIV infection who report cognitive difficulties at baseline.   "
8954|NCT03168711|"     This is a multi-center, 20-week study of inosine treatment.      Study Objectives and Endpoints The primary objective of the study is to determine the safety     and tolerability of oral administration of inosine (administered daily) dosed to moderately     elevate serum urate over 20 weeks.      The primary outcome measures will be        1. Safety, as measured by adverse events        2. Tolerability, defined as the ability of subjects to complete the entire 20-week study.      As an exploratory objective, we will test the feasibility and utility of a smartphone     application for monitoring symptoms and disease progression in patients with amyotrophic     lateral sclerosis (ALS).   "
8974|NCT03168438|"     This study is intended for men and women at least 18 years of age who have relapsed and/or     refractory multiple myeloma. This 2-arm randomized pilot study will test the safety,     tolerability and efficacy of NY-ESO-1ᶜ²⁵⁹T alone (Arm 1) or in combination with pembrolizumab     (Arm 2) in subjects who have the appropriate HLA-A2 marker, and whose bone marrow expresses     the NY-ESO-1 and/or LAGE-1a protein.      This study will take a subject's T cells and give them a T cell receptor protein that     recognizes and attacks the tumors.   "
8978|NCT03168386|"     Early stroke rehabilitation is known to be an effective and essential therapy in gaining     functional independence and preventing complications. However, there was no consensus of     proper amount of motor rehabilitation in stroke patients. In this study, the investigators     investigated the effects of the intensive motor rehabilitation during subacute phase to     improve motor function at 6 months after onset in patients with first-ever strokes.   "
8955|NCT03168698|"     The study investigators are comparing 2 drugs (oxytocin and carbetocin) at 2 different     dosages, to help prevent serious bleeding (hemorrhage) after cesarean deliveries. These drugs     are used routinely to help contract the uterus and keep it contracted after the delivery of     the baby and placenta; this reduces the amount of blood you might lose. At Mount Sinai     Hospital, currently oxytocin is used, but its effect on the uterus is much shorter than that     of carbetocin. Internationally, there is no consensus as to what the most effective drug to     use is and at which dose. The Society of Obstetricians and Gynaecologists of Canada has     recently revised its guidelines to suggest 100 micrograms (mcg) of carbetocin as the drug of     choice at elective cesarean section. Guidelines from the United Kingdom and the United States     currently suggest oxytocin at various doses as the drug of choice at elective cesarean     sections. Previous studies at Mount Sinai Hospital have shown that lower doses of oxytocin,     0.35 International Units (IU), and carbetocin, 20 mcg, may be as effective as the higher     recommended doses. The investigators plan to conduct a large study to confirm these findings     so that they can use the most appropriate dose in the future. Furthermore, the investigators     hope to demonstrate that side effects are lower with the lower dose regimens.   "
8956|NCT03168685|"     The purpose of this study is to evaluate the utility and user experience of a smart phone app     for people with medical conditions, used in conjunction with an ActiGraph wearable device and     a connected scale.   "
8957|NCT03168672|"     This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance     of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post     market surveillance of the device, and may potentially be used for additional market access     purposes.   "
8958|NCT03168659|"     This is a post-approval study to evaluate the clinical outcomes in a cohort of participants     treated during commercial use of the HeartLight System to confirm results of the previously     conducted pivotal clinical study.   "
8959|NCT03168646|"     there are many management options of ulnocarpal abutment depends on clinical evaluation and     imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.   "
8960|NCT03168633|"     Diabetic patients need to manage their glucose level, physical activity and food intake to     successfully cope with their disease. Previous work has shown that reminders of the disease,     be they informational or about ones' condition, can improve management of disease in     diabetes.      This trial focuses on delivering these reminders, via email, in attempt to improve the     patients glycemic control (measured in Hemoglobin A1C)   "
8961|NCT03168620|"     Aim: To evaluate whether glass ionomer interim therapeutic restoration (ITR) in asymptomatic     teeth with deep cavities can help in determining the pulp status. Methodology: 146 mandibular     molars with deep carious lesion having positive response to pulp sensitivity were randomly     allocated to two study groups (75-ITR, 71- NON-ITR group). In the first group after partial     caries removal(PCR), interim therapeutic restoration of glass ionomer cement (GIC) Ketac     molar was placed for one month before definitive adhesive restoration. In NON-ITR group,     cavity preparation was similar to ITR group, but definitive restoration was done in the same     visit. Two examiners evaluated the clinical and radiographic outcomes for 18 months. Success     was defined as absence of signs and symptoms of irreversible pulpitis and absence of     periapical alterations.   "
9152|NCT03166124|"     The purpose of this study is to compare LY900014 with insulin lispro in elderly and younger     adults with type 1 diabetes mellitus.      Screening is required within 28 days prior to the start of the study. For each participant,     the total duration of the clinical trial will be between 3 to 8 weeks.   "
8964|NCT03168581|"     A multicenter, open-label phase 2a trial of CN-105 in patients with supratentorial     intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of     symptom onset. Eligible participants (approximately 60) will receive CN-105 administered     intravenously (IV) for a 30-minute infusion every 6 hours for up to a maximum of 3 days (13     doses) or until discharge (if earlier than 3 days). Participants will be monitored daily     throughout the Treatment phase of the study (up to a maximum of 5 days) and will receive     standard-of-care treatment for the duration of the study. Additional protocol assessments     will be required during the Treatment phase. After discharge from the hospital, participants     will enter a 3-month Follow-up phase, with a clinic visit at 30 days and a follow-up     telephone interview with telephone-validated Modified Rankin Scale (mRS) at 90 days after     first dose of study agent.   "
8965|NCT03168568|"     The objective of this study is to evaluate whether valsartan/sacubitril leads to a superior     improvement in endothelial function and endocrine status compared to valsartan alone.   "
8966|NCT03168555|"     Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral     stimulation with chenodeoxycholic acid in the same subjects before and after elective     cholecystectomy   "
8975|NCT03168425|"     The number of opioid overdose deaths in the United States has quadrupled in 15 years, a     dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp     increase in the amount of legal prescription opioids dispensed. The abundance of prescription     opioids available is a primary pathway for opioid abuse and diversion. Adjusting post-     cesarean delivery opioid prescribing practices to better match actual patient need has the     potential to reduce unused opioids available for diversion, nonmedical use, and development     of chronic dependence, as well as reduce wasted resources.   "
8976|NCT03168412|"     This phase IV clinical study was designed to evaluate the immunogenicity and safety of the     recombinant Hepatitis E vaccine (Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,     in healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers     will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days     schedule or a 0-1-6 month schedule.   "
8967|NCT03168529|"     Ivabradine (IVA) has been shown to decrease the risk of hospitalizations for worsening Heart     Failure and was associated with a trend towards improved mortality in the SHIFT1 trial.     SHIFT1 excluded patients within 4 weeks of hospital discharge, so the efficacy and safety of     IVA in this setting is less clear.      In today's health care environment more and more patients that present to the Emergency     Department (ED) for mild Acute Heart Failure (AHF) are being placed into observation unit and     subsequently discharged, or discharged outright from the ED. This is not only a growing     segment of patients, but also represents an important window of opportunity to intervene with     a potentially effective therapy.      Moreover, at this point in a patient's experience (being discharged after getting treated for     exacerbation of Heart Failure), it's not clear that beta blockers (BB) should yet be     increased/started due to the recent state of exacerbation.      Standard treatment of worsened heart failure presenting to the ED or urgent care includes     diuretics (e. g. furosemide) and vasodilators (e.g. ACE-I, ARB, Hydralazine/Isosorbide or     ARNi), but according to usual standard of care, titration of beta blockade is often reserved     for outpatient follow up after a period of demonstrated stability (in the ambulatory     setting).      This is in contradistinction to hospitalized patients, where patients have been observed by     the treating team for days, presumably show stability and improvement, and starting low dose     BB at the time of hospital discharge has been shown to be safe. As such these ED/Observation     discharge patients are often not optimal candidates for intensification of BB at the time of     release, and could be considered to be at maximally tolerated BB dose (for at least for 2-4     weeks). This may represent a vulnerable period for these patients; its unknown in the setting     of Observation discharge but evidence from hospitalized patients indicates that the highest     daily risk of rehospitalization is in the days just after discharge. IVA may be effective     post observation unit management (where lower risk Heart Failure (HF) patients are typically     placed), to reduce heart rate (without decreasing contractility, such as a BB would) to help     reduce the risk of hospitalization or emergency care, but safety and efficacy (in terms of     heart rate lowering) in this setting has not been previously explored.      Additionally, the SHIFT1 trial lacked African Americans and this unique patient population     has not been previously studied with IVA. The investigating sites serve a predominantly     African American patient population. Therefore the proposed study represents an important     opportunity to gather data on IVA effect in this understudied group of patients.   "
8968|NCT03168516|"     Extremely low gestational age neonates (ELGANs), i.e. those born at <28 weeks, frequently     experience intermittent hypoxemic/hyperoxemic episodes. Observational data indicate that     severe and prolonged hypoxemic episodes are associated with retinopathy of prematurity (ROP),     impaired long-term development and death. Closed-loop automated control of the inspiratory     fraction of oxygen (FiO2-C) reduces time outside the oxygen target range, decreases number     and duration of hypo- and hyperoxemic episodes, and reduces caregivers' workload. The     proposed observer-blinded randomized controlled trial was designed and will be powered to     compare the effect of FiO2-C in addition to manual adjustments, in comparison with manual     adjustments of FiO2 only, on death and severe complications of prematurity thought to be     related to hypoxia/hyperoxia and neurodevelopmental impairment in ELGANs. The results of this     trial may help to improve the quality of life of ELGANs and reduce the burden of significant     morbidity as well as costs for health care and society   "
8969|NCT03168503|"     The aging process leads to a marked decline in immune function (immunosenescence), causing a     significant reduction in immune response after vaccination or infections. Dietary     intervention is an attractive, safe and non-invasive way to impact on gut bacteria and     subsequently the functioning of the immune system. The ability of the dietary supplementation     to alter these functions can be of particular importance in those groups that have an     underdeveloped, poorly functioning immune system such as infants, immuno-compromised subjects     or elderly. Research over the past two decades has provided evidence that administration of     probiotics (live microorganisms which, when administered in adequate amounts, confer a health     benefit on the host) could enhance immune function. Lactobacilli and bifidobacteria are the     most common probiotics used in humans and various strains have been shown to have     immunostimulatory properties in vitro and in experimental models, these properties include     modulation of cytokine production. evidence exists of the immunostimulating effects of     certain probiotics and the potential to use prebiotics to increase the levels of beneficial     bacteria (which are known to be reduced in elderly population). Furthermore, by providing a     probiotic at the same time as a prebiotic conditions for survival are enhanced. To date, only     a small number of studies conducted have been randomised and/or placebo controlled to     unequivocally demonstrate efficacies.   "
9013|NCT03167931|"     The main objective of this study is to estimate the effect of the neuromodulation on the     behavioral performances during the access in semantics according to the age of the     individuals.      Neuromodulation by non-invasive stimulation allows to explore the functioning of the brain by     exciting or by inhibiting localized cortical zones. The modulation of the performances in     cognitive tasks, further to the neuromodulation of these zones, allows to deduce on their     functional roles.   "
8970|NCT03168490|"     In the last two decades, a series of epidemiological studies have shown a particular increase     in Coeliac Disease (CD), a life-long intolerance to gluten proteins (the seed storage     proteins) present in most cereals (wheat, barley and rye) both in the United States and     Europe, and in developing countries. In these subjects, the consumption of cereals containing     gluten causes a chronic inflammatory process leading to lesions in the small intestine and a     dysfunction in nutrient absorption.The only current treatment for CD is a strict lifelong     gluten-free diet. In most cases (some people do not respond) this dietary regimen guarantees     the full recovery of small intestine architecture and functions, though for many patients the     gluten-free diet is highly restrictive, especially for social events and during travelling.     In addition, this dietary therapy has often low content of vitamins and ions, such as     vitamins B and calcium, iron, zinc and magnesium, as well as fibre. Furthermore, one of the     major risks is to develop obesity and diseases related to metabolic syndrome.      Recently a new and innovative detoxification method has been developed with the purpose to     overcome the disadvantages of the prior methods. The method is based on the application of     microwave energy for few seconds to hydrated wheat kernels; the treatment induces     modifications to endosperm components which dramatically reduce the immunogenicity of the     most common epitopes involved in coeliac disease, without compromising the technological     properties necessary to process flour into bread, pasta and other baked goods.      The method is based on the analysis of recent studies that have reported, when high     temperatures are applied to the caryopsis of wheat, the protein polymers present in the pasta     produced with these baked grain present a size distribution pattern that is not observed in     pasta during the drying cycles. The researchers Lamacchia and others explained this     phenomenon on the basis of the fact that in the caryopsis of wheat, gluten is not yet formed     and gluten proteins are deposited in different protein bodies.   "
8971|NCT03168477|"     The purpose of this research is to compare two different approaches for treating patients     with shoulder impingement: electric dry needling and spinal manipulation versus     impairment-based manual therapy, exercise electro-thermal modalities. Physical therapists     commonly use all of these techniques to treat shoulder impingement. This study is attempting     to find out if one treatment strategy is more effective than the other.   "
8972|NCT03168464|"     NSCLC patients with metastatic disease who have failed at least one prior treatment and have     a minimum of two metastatic lesions (at least one measurable), are eligible if they have an     ECOG Performance Status of 0-1. Patients will receive on Day 1, ipilimumab (every 6 weeks)     concurrently with radiation (6Gy x 5 fractions). Nivolumab (every 2 weeks) will be given in     addition to ipilimumab on day 22.   "
8973|NCT03168451|"     In an attempt to reduce smoking-related health disparities, investigators will implement a     text messaging-based smoking cessation intervention in collaboration with state quit lines.     The approach is based on the successful STOMP (STOp smoking by Mobile Phone) program, a text     messaging-based smoking cessation intervention among young Maori adults in New Zealand.     Investigators will adapt the STOMP intervention, which will result in a new intervention     known as AI STOMP (American Indians STOp smoking by Mobile Phone).The primary aim of the     study is to determine the effectiveness of the AI-STOMP intervention in smoking cessation     among American Indians.   "
8979|NCT03168373|"     Early stroke rehabilitation is known to be an effective and essential therapy in gaining     functional independence and preventing complications. However, there was no consensus of     proper amount of language rehabilitation in stroke patients. In this study, the investigators     investigated the effects of the intensive language rehabilitation during subacute phase to     improve language function in patients with first-ever strokes.   "
8980|NCT03168360|"     Early stroke rehabilitation is known to be an effective and essential therapy in gaining     functional independence and preventing complications. However, there was no consensus of     proper amount of cognitive rehabilitation in stroke patients. In this study, the     investigators assess the effects of the intensive cognitive rehabilitation during subacute     phase to improve cognitive function at 6 months after onset in patients with first-ever     strokes.   "
8981|NCT03168347|"     In dermatology, biologic medications are used to treat conditions such as moderate-to-severe     psoriasis. These medications generally function to decrease inflammation or disrupt the     inflammatory cycle. Examples of biologic medications commonly used in dermatology include     tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab,     certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A     blockers (secukinumab, ixekizumab).      Due to biologic medication's efficacy and safety profiles, they have revolutionized     dermatology and the general medical field. However, patients may be apprehensive about     choosing a biologic medication for a variety of reasons. These include hearing negative     information about the drug from friends or family, being nervous about injection, or seeing     the drug or its side effects negatively portrayed in the media. Many patients are not aware     that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence     in choosing to take these medications.      Because fear of the drug is inherently subjective, it can be modified with appropriate     reassurance and presentation of evidence. Physicians must be able to ascertain from where the     fear originates and how it can be countered. By understanding what kind of information will     allow patients to be confident in their decision to take a biologic, dermatologists can     improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or     adverse events may improve adherence to treatment and may improve treatment outcomes. The     investigators propose this study with the goal of learning whether patients are more     confident in the potential success of biologic medications in treating their psoriasis after     being presented with clinical trial evidence, anecdotal evidence, or both.   "
8982|NCT03168334|"     This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed     to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123Vehicle Lotion.   "
8983|NCT03168321|"     This is a multicenter, randomized, double-blind, vehicle-controlled study designed to assess     the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle     Lotion.   "
8984|NCT03168308|"     This prospective, randomized, double blinded study is intended to enroll a total of 92     patients undergoing thoracic surgery with general endotracheal anesthesia at Parkland     Hospital. Patients will be randomized to receive either neostigmine or sugammadex for     reversal of neuromuscular blockade. Merck, Inc. will supply the sugammadex through an     agreement with Parkland Investigational Drug Services. Neostigmine is readily available for     anesthesiologists to use and is the current standard of care for reversal of neuromuscular     blockade. A standardized anesthetic protocol that is usual and customary for the type of     operation the patient is having will be provided to the anesthesia teams of enrolled     subjects. The remainder of the anesthetic care of the subject will not deviate from the     standard of care. The surgeon, anesthesia team, PACU nurse, and research assistant will be     blinded as to which reversal drug the patient receives. The only individual that will know to     which drug the patient has been randomized will be the pharmacist who draws up the     medication(s). A blinded research assistant will record postoperative outcomes and the     patient will be followed until postoperative day (POD) 3.   "
8985|NCT03168295|"     Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose     concentration in diabetic subjects after kidney transplantation (i.e. renal denervation) or     in subjects after renal sympathectomy (63) can add insight about the possible role of a     neural arc which mediates the changes in plasma glucagon and/or insulin concentration in     response to glucosuria.   "
8986|NCT03168282|"     The purpose of this study is to determine the feasibility of identifying novel etiologic     agents associated with SARI in patients who have required intubation and in whom, after     analysis, a causative agent was not identified by standard microbiologic (culture) and     multiplex real-time Polymerase Chain Reaction (PCR) platforms. Taking into account that     isolation of any pathogens is generally time sensitive, the study will evaluate subjects that     are culture negative at the time of consent. Not all subjects will actually prove to be     culture negative. Additionally, the study will compare etiologic agents identified on     broncho-alveolar lavage (BAL) to etiologic agents identified by routine upper airway testing     on all subjects with SARI.   "
8987|NCT03168269|"     Coronary Computed Tomographic Angiography (CCTA) is emerging as the diagnostic test of choice     in chest pain patients with low to intermediate probability of coronary artery disease (CAD).     Qualified CCTA readers may not be available around the clock in most centers, limiting the     use of CCTA. This study aimed to determine if well-qualified CCTA technicians can provide     initial accurate diagnosis to guide initial management and triage of such patients   "
8988|NCT03168256|"     This trial will test the hypothesis that the administration of CF101, a novel     anti-inflammatory agent, to patients with moderate to severe plaque psoriasis will relieve     signs and symptoms of the disease. CF101 effect will be in comparison to apremilast in this     study population   "
8989|NCT03168243|"     Enteral tube feeds are commonly used to meet the entire or partial nutritional requirements     of patients with disease-related malnutrition and other conditions who need nutrition     support. A large proportion of tube fed patients have increased protein and/or energy     requirements due to a higher body mass or increased metabolic stress as a result of disease,     surgery or trauma. A high energy, high protein feed has been developed to help meet the needs     of such patients. The aim of this study is to investigate the tolerance, compliance and     acceptability of this high energy high protein tube feed in adult patients who require     nutritional support via tube feeding. 50 eligible patients requiring tube feeding will     receive the high energy, high protein feed, according to nutritional requirements for 4     weeks. The primary outcome is nutritional intake, and secondary outcomes include     gastrointestinal (GI) tolerance, compliance, acceptability and functional measures.     Additional exploratory outcomes of quality of life and micronutrient levels will also be     investigated.   "
9003|NCT03168061|"     The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to     patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of     the drug will also be studied.   "
8990|NCT03168230|"     For patients with colorectal liver metastasis (CLM), the prospect of long-term survival     relies on liver resection. Wistfully, more than 75 % of patients with CLM are initially     unresectable, due to an insufficient future liver remnant (FLR) volume      In order to increase FLR volume, most patients will first receive chemotherapy to reduce the     tumor load (downsizing).      When chemotherapy is insufficient to provide an adequate postoperative FLR, portal vein     embolization (PVE) can be performed. About 50-70 % of patients undergoing PVE obtain a     sufficient liver hypertrophy to allow liver resection.      While PVE is recognised for its efficacy to induce liver hypertrophy, some studies expressed     substantial concerns regarding the potential adverse effect of this intervention on     pre-resection tumor progression, increased risk of cancer recurrence following resection and     reduced overall survival following resection      Those studies suggested that the need to perform PVE should be assessed thoroughly for each     patient and that chemotherapy should be maintained during the whole hypertrophy process in     order to contain the potential adverse effect of PVE on tumor progression.      Other studies found no significant association between PVE and negative oncological outcomes.      As mentioned in almost every study cited above, more data is needed to provide a clearer     vision regarding the impact of PVE on tumor progression and cancer recurrence following liver     resection.      The aim of this study is to compare the overall and disease-free survival of PVE-requiring     patients to the ones who underwent upfront surgery (NoPVE).      As a secondary objective, the impact of several covariates (related to surgery, patient's     condition and disease stage) on survival and cancer recurrence will be tested.      Our hypothesis are that 1) PVE might be associated with a lower overall survival and a higher     risk of cancer recurrence in univariate analysis but 2) this association will not remain     significant when other covariates are included in the proportional COX hazard models.   "
8991|NCT03168217|"     This study aims to identify phenotypic groups of patients with periodontitis by applying a     cluster analysis.   "
8992|NCT03168204|"     The evaluation of a detection and prevention program which aims to create a continuum of care     and support for frail community-dwelling older people (from early detection, over     intervention, to follow-up). First, the program aims to develop methods to easily, accurately     and timely detect and prevent a negative frailty-balance in older people. Second, the study     aims to improve the quality and efficacy of care and support given to frail     community-dwelling older people.   "
8993|NCT03168191|"     This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination     with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine.     The hypothesis is that menthol and the other experimental flavor will interact with nicotine     dose to improve taste and liking for e-cigarettes.   "
8994|NCT03168178|"     The purpose of this study is to determine whether antibiotics can be safely avoided in women     who develop a fever during labor. Because investigators have no accurate tests to determine     whether women who develop fever during labor have intra-amniotic infection, antibiotics are     often used to prevent spread of infection to the fetus.   "
8995|NCT03168165|"     This is a cluster randomized trial that involves training regions of physical therapy clinics     to use pain neuroscience education or continue with usual care. The investigators will     examine outcomes for patients with chronic neck or back pain.   "
8996|NCT03168152|"     This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body     radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).      This trial will be the first prospective comparison of these modalities for the treatment of     HCC and will provide critical information regarding which local ablative modality is most     appropriate for which patients. This study will also provide important information regarding     quality of life and liver function changes following these two different treatment     modalities.   "
8997|NCT03168139|"     The purpose of this study is to show that the type, number and/or distribution of tumor     metastases infiltrating immune cells such as cytotoxic T cells and/or the cytokine signature     in the tumor metastases can be modulated by treatment with olaptesed pegol and to explore     safety, tolerability and efficacy of olaptesed pegol in combination with pembrolizumab as a     basis for subsequent studies in combination with immunotherapies, in particular checkpoint     inhibitors.   "
9014|NCT03167918|"     To investigate the protective effect of calcium dobesilate, Xuefuzhuyu Decoction, calcium     dobesilate combined with Xuefuzhuyu Decoction on the early lung function of type 2 diabetes     mellitus   "
8998|NCT03168126|"     Background: Anesthesia in free flap surgery is challenging. Monitoring of hemodynamic changes     and their influence on the cardiovascular system in permanent feedback loops allow control,     which is what anesthesiologists aim for to ensure an adequate blood flow and tissue     oxygenation. The circulatory support and inferable volume administration are managed via     heart rate (HR) and mean arterial pressure (MAP), but both parameters are influenced by     variable components and are thus unfavorable for volume management. The aim of this study was     to evaluate whether volume requirement may be assumable to additional monitoring parameters.      Methods: 31 patients were enrolled prospectively. HR, MAP, central venous pressure and O2     saturation were comprehended based on the protocols. We expanded the data set by a permanent     blinded intraoperative monitoring with registration of the Cardiac Index (CI) and Stroke     Volume Variation (SVV) and semi-invasive pulse-contour analysis utilizing the Pro-AQT-Device.   "
8999|NCT03168113|"     This is a prospective, single center, clinical mechanistic pilot clinical research study.     Participants will not receive any investigational agent. The investigators will examine     whether children with atopic dermatitis (AD) and food allergy have a different skin barrier,     microbiome, epidermal transcriptome, and epidermal lipid composition than children with AD     and no food allergy and non-atopic (NA) children. Participation involves a single study     visit.   "
9000|NCT03168100|"     The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated     great improvement in treatment outcomes for multiple myeloma patients. However, some patients     still relapse early during maintenance treatment meaning that better options are still     needed. This study will evaluate a treatment regimen that alternates two different 3-drug     regimens every eight weeks for patients that have previously completed autologous stem cell     transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will     be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will     be measured by the depth of response (i.e., whether or not minimal residual disease (MRD)     negative status is achieved). The rate of MRD negativity from this study will be compared to     historical control data from the Total Therapy 4 trial which used continuous VRD maintenance     therapy after stem cell transplant(s).   "
9001|NCT03168087|"     Fluids administered intravenously may alter whole blood coagulation. However, little is known     about the dose-response relationships of hemodilution in plasmalyte-148 solution.     Investigators have therefore performed the present study to measure the effect of a     plasmalyte-148 solution on the coagulation pathway according to the hemodilution level using     a rotational thromboelastometry (ROTEM®) tests.   "
9002|NCT03168074|"     The Investigators hypothesize that single agent lenvatinib has biological activity in     estrogen receptor positive breast cancer, and that the effects are more pronounced in     patients with positive RET expression in the tumor.   "
9004|NCT03168048|"     The present single-center prospective exploratory study, conducted at Heidelberg University     Hospital, assesses the feasibility of introducing a concept for additional patient care based     on a mobile application for patients undergoing radiotherapy. Patients presenting themselves     for the irradiation of thoracic or pelvic tumors will be surveyed regarding general     performance, treatment-related Quality of Life (QoL) and symptoms and their need to     personally consult a physician on a treatment-daily basis by means of a mobile application.     The primary endpoint of feasibility will be reached when 80% of the patients have     successfully answered 80% of their respective questions scheduled for each treatment day.     Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by     PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.   "
9005|NCT03168035|"     The goal of this clinical research study is to find the highest tolerated dose of NC-4016     that can be given to patients with advanced solid tumors or lymphoma. The safety of the drug     will also be studied.   "
9006|NCT03168022|"     This study is an open-label, 2-way crossover, single-dose study that is being performed to     establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers:     manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial     drug product. This bioequivalence study will confirm (1) the drug product manufactured from     these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data     obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.   "
9007|NCT03168009|"     The mechanisms of bariatric surgery-induced weight loss go beyond reductions in calorie     intake and may involve several other pathways. Recently, brown adipose tissue (BAT) has been     added as another potential player. Activation of BAT results in enhanced energy expenditure     and promotes weight loss. Here, the investigators will study the effects of bariatric surgery     on BAT function by PET/CT studies and molecular analyses of adipose biopsies. The     investigators will explore different pathways that may affect BAT activation in this patient     population.   "
9008|NCT03167996|"     This platform will enable investigation the cardiovascular risk reduction and the increase in     participantengagement in their heart-healthy goals, through the use of a digital platform     that connects them to their own doctors, nurses, and dietitians.   "
9009|NCT03167983|"     From this study, it is hoped to learn if and how the gut microbiome composition, gut     permeability and inflammation in patients with dementia are associated with each other.     Dysbiosis may lead to an increased gut permeability, bacterial translocation and inflammation     which may influence pathogenesis and progression of dementia.      The novel aspect of the study will be to understand the association between gut microbiome     composition, gut permeability and the presence of dementia. This will help to better     understand the pathogenesis of dementia and lead to the development of novel therapeutic     strategies. If this hypothesis holds true, the study will be the basis to develop new     treatment options for dementia.   "
9010|NCT03167970|"     This study is to examine the benefits of newly designed capsule with enhanced frame rate and     wide angle compared to standard endoscopy, which may help enhance detecting esophageal     diseases that otherwise may have been out of vision in the standard endoscopy, ultimately     decreasing healthcare costs.   "
9011|NCT03167957|"     This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB     dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).   "
9178|NCT03165786|"     This study is being conducted to determine the feasibility of a cognitive behavioral therapy     intervention to reduce fear of hypoglycemia and improve glucose levels in young adults with     type 1 diabetes.   "
9016|NCT03167892|"     Stroke is a common disease in older people, and often leads to various degrees of disability.     Dysphagia is one such consequence which is associated with aspiration pneumonia and     malnutrition. There are studies showing that oral screen-training may reduce dysphagia, but     the method is insufficiently evaluated. Since treatment with an oral screen is easy,     relatively quick and cheap, it is of high relevance to perform a strict and unbiased study to     assess the feasibility and efficacy of the intervention. Thus, the aim of the present study     is to evaluate the effect of daily oral screen training in post-stroke patients with     dysphagia.      A randomized controlled clinical study will be performed in subjects who have had a first     stroke 8-12 months earlier and suffer from dysphagia. The intervention consists of daily oral     screen training for 3 months. In total 70 subjects will be randomized to intervention or     control. The changes in swallowing capacity is the main outcome, and secondary outcomes are     subjective swallowing problems, lip force, chewing function and quality of life.      Improved oral motor function and decreased dysphagia in post-stroke patients will result in     an improved quality of life for the individual, and also reduce hospitalization and health     care costs.   "
9017|NCT03167879|"     This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family     planning (FP) program that incorporates a structured, multi-component safer conception     counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2;     less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new     services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by     The AIDS Support Organization (TASO) Uganda.   "
9018|NCT03167866|"     The investigators will examine the influence of increasing motivation on healthy lifestyle     and glycemic control in diabetes patients. Participants will be randomized to two groups, the     control group gets informational text message and the intervention group gets motivational     SMS. The patients get a weekly text message and after 26 weeks the HbA1c and quality of life     will be assessed.   "
9019|NCT03167853|"     This is a single-center, open-label, phase Ib study evaluating safety and efficacy of the     humanized anti-PD-1 antibody JS001, as a monotherapy in patients with neuroendocrine tumors     who have failed in previous systemic treatment. 40 patients are enrolled and injected with     the humanized anti-PD-1 antibody 3mg/mg every 2 weeks until disease progresses or     unacceptable toxicity.   "
9020|NCT03167840|"     This randomised controlled trial aims to determine the effectiveness of combined physical and     cognitive training in preventing falls and decreasing risks of falls among community-dwelling     older persons with mild cognitive impairment (MCI).   "
9021|NCT03167827|"     This study evaluates the effect of Physical Training and Supplementation of Isoflavone About     Pelvic Floor Musculature in Women in the Postmenopausal period, and it has two groups the     intervetion.   "
9022|NCT03167814|"     Chyle is lymphatic fluid present in the wall of the intestine. It flows trough lymphatic     vessels to cisterna chyli and to venous circulation carrying lymphatic fluid, long-chain     triglyceride fatty acids and proteins, fatty soluble vitamins and electrolytes. Lymphatic     vessels are at risk of damage in pancreatic surgery and especially when there is vein/artery     resection and reconstruction at the same time. Chyle leak can be seen in post-operative     patients when there is milky substance coming out of the surgical drains and drain fluids     triglyceride level is high (>1,5 mmol/l). Patients with chyle leak are at risk of     dehydration, malnutrition, sepsis and prolonged stay at the hospital. Usually treatment of     chyle leak is with drains and no-fat diet up to 14 days after surgery. Sometimes combined     with somatostatine-analogue-treatment. In this study investigators are randomizing patients     with major pancreatic surgery in to two groups. Intervention group will start no-fat diet,     including MCT-oil, right after surgery up to 2 weeks. And control group will start the diet     if chyle-leak is seen. End goal is to reduce chyle-leaks in post-operative patients and     analyze if it has an effect on patients prognosis.   "
9023|NCT03167801|"     To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord     injury patients versus a database of healthy volunteers.   "
9024|NCT03167788|"     The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and     inflammation will be less if patients undergoing cardiac surgery who are at risk of large     volume blood transfusion (defined as the administration of ≥4 units of red cells) receive     rejuvenated washed cells compared to standard care (unwashed aged stored cells).   "
9025|NCT03167775|"     Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best     Supportive Treatment in the Treatment of Advanced Primary Liver Cancer   "
9026|NCT03167762|"     Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade     forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed     in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent,     meaning that it produces red light when blue light is shone on it. By measuring how much     light is given off with a camera, the investigators can determine how much photosensitiser is     present in the skin. Also, it is thought that more of the chemical is converted to the active     photosensitiser if the skin is warmer, so the investigators plan to measure the temperature     of the skin using a thermal camera. Light is shone on to the skin and this activates the     photosensitiser, treating the problem area and leaving healthy skin intact. This research     will increase the investigators understanding of how PDT works, and may help the     investigators to improve treatment regimens so that they can be made more effective and     better tolerated   "
9027|NCT03167749|"     Normal testicular hormonal and spermatogenic function depends not only on the testis itself,     but also on the integrity of the hypothalamus and anterior pituitary. Systemic diseases has     been shown to influence male gonadal function in variety of ways, leading to reduced libido,     erectile impotence, infertility, osteoporosis, and decreased physical stamina and muscle     mass. The effect of systemic diseases may occur directly at the testicular level: reduced     Leydig cell function will lead to androgen deficiency, while diseases affecting     Spermatogenesis may lead to infertility. Alternatively, acute and chronic illness may     interfere with the hypothalamic-pituitary axis and lead to reduced testicular function.   "
9179|NCT03165773|"     The objectives of this study are to assess the 4 hr postprandial kinetics of total and     exogenous glucose in response to consumption of oatmeal containing a high percentage of the     viscous agent β-glucan, in comparison to a β-glucan free corn cereal that is matched by grams     of available carbohydrate.   "
9029|NCT03167723|"     Traumatic hemothorax and hemopneumothorax are common diagnoses which are typically treated by     placement of a chest tube. 28-32 Fr chest tubes have previously been shown equivalent to     36-40 Fr chest tubes for the non-emergent drainage of hemothorax. A smaller study has found     14 Fr pigtails had less pain than larger tubes but was not powered to compare outcomes. We     seek to perform a prospective randomized trial that is adequately powered comparing efficacy     of 14 Fr thal tubes to 28 Fr chest tubes for non-emergent drainage of hemothorax and     hemopneumothorax. Additionally, we will employ maximal barrier precautions for all chest tube     insertions and compare empyema rates to our historical controls.   "
9030|NCT03167710|"     The purpose of this research is to compare two different approaches for treating patients     with lateral epicondylalgia: electric dry needling, thrust manipulation and stretching versus     impairment-based manual therapy, exercise and ultrasound. Physical therapists commonly use     all of these techniques to treat lateral epicondyalgia. This study is attempting to find out     if one treatment strategy is more effective than the other.   "
9061|NCT03167307|"     This study investigates the therapeutic efficacy and safety of omega-3 fatty acids rich in     eicosapentaenoic acid / docosahexaenoic acid in pediatric depression in a nine months     double-blind multi-centre study in 220 children and adolescents between 8 and 17 years of     age. Inflammatory and bioactive lipid markers as predictors of response are evaluated. The     relationship between omega-3 fatty acids with psychopathology, illness course and cognitive     parameters will be further investigated.   "
9031|NCT03167697|"     This study centres around a new one-a-day phenylalanine-free protein substitute for     phenylketonuria patients. Fifty eligible adults (≥ 16 years) with proven phenylketonuria or     hyperphenylalaninemia will be recruited and randomly allocated to one of two intervention     arms (n = 25 per arm). Following a 3-day baseline period, and in addition to routine     nutritional management, patients will receive either one sachet of the new protein substitute     daily (intervention) or continue their usual dietary and/or protein substitute regimen     (maximum of 1 protein substitute per day (equal to 20g protein equivalent) control) for 28     days.   "
9032|NCT03167684|"     This study will evaluate the impact on blood glucose of the use of an oral appliance to treat     obstructive sleep apnea (OSA) in individuals with Type 2 diabetes. An oral appliance is     similar to a sports mouth guard or an orthodontic retainer and is an alternative treatment to     continuous positive airway pressure (CPAP) for OSA. Oral appliance therapy has not been     evaluated in patients with Type 2 diabetes with respect to glycemic outcomes. This will be a     1:1 randomized controlled trial: The experimental group will receive the oral appliance and     the control group will receive a sham device over the course of approximately 5 months.   "
9033|NCT03167671|"     AposTherapy is a home based exercise program utilizing footwear that causes exercise with     normal activity that may significantly improve function in patients with back pain since     patients with back pain have altered mechanics of motion contributing or due to the presence     of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of     ApostTherapy in patients with significant knee and back pain, we propose to evaluate this as     a conservative treatment that may supplant/supplement traditional pain medications and     physical therapy in an at-risk urban inner city population.   "
9034|NCT03167658|"     There is great public and private interest in the use of workplace wellness programs to     reduce health care spending, improve health outcomes, and enhance productivity for employees.     However, there is little rigorous evidence on the effects of wellness programs. This study     partners with a large multi-state U.S. employer (BJ's Wholesale Club) and an experienced     wellness vendor (Wellness Workdays) to evaluate a multi-prong workplace wellness program,     including components such as nutrition counseling, fitness challenges, and stress management     workshops. The wellness program will be delivered by a team of experts and aided by     innovative technologies, and will include financial rewards for participation. The program     will be available to employees in 25 of BJ's 200 worksites. These sites have been randomly     selected, allowing a randomized controlled evaluation of the effects of the wellness program.     Data will be collected on a wide array of outcomes from multiple sources, including on-site     biometric screenings and surveys, employment records, and health insurance claims for     employees at both treatment and control sites.   "
9035|NCT03167645|"     Aim of this study is to reduce postoperative complications (assessed by POMS-Score and graded     by Clavien-Dindo-Score) by substitution of perioperative hypoalbuminaemia in high-risk     patients or patients undergoing high risk surgery.   "
9036|NCT03167632|"     Oral Ulcers have serious effect on patients' lives. Due to absence of any information about     its prevalence, risk factors and effect on patients' lives, this study has been held. The     investigators recruited patients from the outpatient dental clinic of the faculty of oral and     dental medicine, Cairo University, screened them clinically for oral ulcers. All patients     filled questionnaires about the risk factors of oral ulcers. Furthermore, oral ulcer patients     filled questionnaires about their Quality of life, previous treatments used, previous     physicians visited and their Quality of life after using previous treatments.   "
9037|NCT03167619|"     This is a randomized, international, multicenter, Phase II study designed to explore the     efficacy of olaparib or olaparib in combination with durvalumab in platinum-treated mTNBC.     The primary objectives are to explore olaparib or olaparib in combination with durvalumab as     maintenance therapy following clinical benefit with platinum-based therapy in subjects with     mTNBC.   "
9038|NCT03167606|"     The proposed MyPEEPS Mobile intervention is a novel and evidence-driven intervention using     mobile technology to deliver HIV prevention information specifically developed for at-risk     young men who have sex with men (YMSM). This will be the one of the first studies to test the     efficacy of a scaled-up, mobile version of an existing human immunodeficiency virus (HIV)     prevention intervention originally developed for, designed by, and piloted for, a diverse     group of YMSM.      MyPEEPS Mobile will be tested in an randomized controlled trial with racially and ethnically     diverse HIV-negative or unknown status YMSM aged 13-18 at four geographically diverse sites:     Birmingham, Chicago, New York City, and Seattle, allowing for increased generalizability of     findings.   "
9241|NCT03164967|"     This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in     subjects aged 2-16 with primary immune deficiency disorders associated with defects in     humoral immunity to generate additional data on these populations, and more specifically     safety and pharmacokinetic (PK) assessments.   "
9039|NCT03167593|"     The objective of the present study is to evaluate the capability of the probiotic strain     Lactobacillus coryniformis K8 CECT5711 (Lc K8) to enhance the immune response to influenza     vaccine in elderly and the effect on respiratory symptoms related to respiratory infections.      A randomized, double-blind, placebo-controlled trial was conducted between November of 2015     and April of 2016. A total of 98 residents of nursing homes aged more than 65 years were     randomly assigned to receive Lc K8 or placebo for two weeks previous to influenza     vaccination.      Primary outcome was the percentage of seroconversion. Secondary outcome were the incidence of     influenza-like illness and respiratory symptoms associated to respiratory infections during     the follow-up period of 5 months. Serum cytokines and immunoglobulins levels were also     evaluated.   "
9040|NCT03167580|"     The 'REstricted versus Liberal positive end-expiratory pressure in patients without Acute     respiratory distress syndrome' (RELAx) trial is a national multicenter, open randomized     controlled trial in ICU patients without ARDS at start of ventilation. It will be the first     RCT comparing ventilation with the lowest possible positive end-expiratory pressure (PEEP)     level with ventilation with the median PEEP level currently practiced in the Netherlands that     recruits a sufficient number of patients to test the hypothesis that ventilation with the     lowest possible PEEP level is non-inferior to ventilation with a PEEP level of 8 cm H2O with     regard to objective and patient-relevant clinical endpoints.   "
9041|NCT03167567|"     Women during their first labor will be offered the assistance of a medical clown. Their     experience will be compared after delivery with that of primiparae who were not helped by a     medical clown.   "
9062|NCT03167294|"     The primary objective of this study is to evaluate the safety and performance of the     AQUABEAM® System device for the treatment of lower urinary tract symptoms associated with BPH   "
9042|NCT03167554|"     Achilles tendon is a frequent lower-limb tissue where tendinopathy may arise. Percutaneous     Therapeutic Electrolysis (EPTE®) is an electronic device that enables to treat accurately,     guided by an ultrasound, the tendon injured area by applying a galvanic current through an     acupuncture needle. Thus, the first stage of physiological regenerative process may be     obtained. Design: Randomized Controlled Clinical Trial. Objectives: To know the effectiveness     of Percutaneous Therapeutic Electrolysis (EPTE®) versus a sham intervention at improving pain     and function in patients who undergo Achilles Chronic Tendinopathy and to determine the     efficiency of Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle versus     Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle at improving pain and     function in patients who undergo Achilles Chronic Tendinopathy. Participants: patients     diagnosed with Achilles Chronic Tendinopathy. Setting. Infanta Leonor Hospital, Madrid,     Spain. Experimental intervention: Percutaneous Therapeutic Electrolysis (EPTE®) with     monopolar needle, 330 microamps, 1 min 20 sec versus bipolar needle. Sham intervention: the     guide tube of the needle contacted with the skin and the device remained switched on to     simulate its functioning.   "
9043|NCT03167541|"     This study is being conducted to investigate the rate and extent of naproxen absorption from     the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference     product currently marketed in The Netherlands in order to support the registration of the     Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).   "
9044|NCT03167528|"     The aim of the study is to evaluate, 3 months after lung transplantation, integration and     appropriation by the patient of complementary techniques ( Toolbox  included relaxation,     autohypnosis, relaxation therapy, TENS (if pain) and holistic gymnastics to improve the     comfort and the quality of life in very high-technology care pathway   "
9045|NCT03167515|"     The primary objective of this study is to determine the efficacy and safety of 074-6751     Lotion applied twice daily for four weeks (28 days) in clinical subjects with moderate plaque     psoriasis.   "
9046|NCT03167502|"     Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No     studies have compared the effect of eccentric versus concentric reinforcement in knee     osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement. This     is a randomized, interventional trial.   "
9047|NCT03167489|"     This pilot study aims to demonstrate that emotional regulation (ER) is a valuable supplement     to a documented and effective group-based lifestyle intervention on cardiovascular disease     risk reduction maintenance in a non-clinical population by assessing changes in this primary     outcome: Mediterranean diet adherence and these secondary outcomes: average daily steps, METS     per week, BMI, blood pressure, physical activity, LDL, HDL, Triglycerides, Hemoglobin A1c,     Western Diet Score, ER skills, Healthy Heart Score and eating behavior. This study will     include 14 female hospital employees and the group intervention will be based on the gold     standard Diabetes Prevention Study, integrating the Mediterranean Diet as well as emotional     regulation skills based on dialectical behavior therapy. The core intervention will last 3     months with 2 booster sessions will be conducted over 2 months.   "
9048|NCT03167476|"     The objectives are to:        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the          tissue of patients with and without reactive hyperplasia and lymphoma.        2. investigate the physiological range of the miRNA panel in lymphoma and reactive          hyperplasia subjects.        3. investigate the dysregulation of miRNA panel and their prognostic and predictive values          in clinical outcomes to identifying patients with malignant lymphoma or reactive          hyperplasia.      The objectives are to:        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the          tissue of patients with and without reactive hyperplasia and lymphoma.        2. investigate the physiological range of the miRNA panel in lymphoma and reactive          hyperplasia subjects.        3. investigate the dysregulation of miRNA panel and their prognostic and predictive values          in clinical outcomes to identifying patients with malignant lymphoma or reactive          hyperplasia.      This trial involves tissue samples diagnosed as lymphoma and reactive hyperplasia. The     investigators will develop panels of miRNAs that are specific biomarkers of lymphoma, and     assist clinical outcomes with these miRNAs.   "
9265|NCT03164655|"     National trial, multicenter, randomized, phase II comparing treatment intensification with     hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic     chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still     non resectable after at least two months of systemic induction chemotherapy.   "
9049|NCT03167463|"     Congenital choanal atresia is an abnormality of the posterior nasal passages resulting in     complete or partial obstruction of the nasal airways. It has an incidence of 1: 5000 to 8000     live births, with a female predominance. 41% - 72% occur in conjunction with non-syndromic     facial abnormalities such as arched palate, cleft lip, and auricular deformities. About 4%     present as a component of chromosomally-based syndromes such as (coloboma, heart defect,     atresia choanae, retarded growth, genital abnormality, and ear abnormality and Treacher     Collins syndromes.      Previous reports have described the ratio of bony to membranous choanal atresia as 9:1.     However, a detailed review of computed tomography study combined with histopathological     studies has shown mixed bony-membranous atresia in about 70% of cases and purely bony atresia     in 30% of cases.   "
9057|NCT03167359|"     As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now     seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the     traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema     are some of the most common acute and potentially long-term debilitating toxicities of BrCA     XRT.      The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the     breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily     radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.   "
9058|NCT03167346|"     To investigate public awareness of core stroke symptoms in more than 40 years old population     and its related factors.   "
9059|NCT03167333|"     To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into     synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce     synovitis.   "
9060|NCT03167320|"     The Low Von Willebrand in Ireland Cohort (LoVIC) study focuses on the bleeding phenotype and     biological mechanisms underlying low Von Willebrand Factor (VWF) levels.   "
9130|NCT03166410|"     This study will examine the safety and efficacy of autologous adipose-derived stromal     vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA);     monitoring adverse events and measuring pain, function and stiffness in the joints of     osteoarthritic subjects.   "
9052|NCT03167424|"     The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular     Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence,     predisposing factors, pathophysiology and prognosis of the patient in this setting.   "
9053|NCT03167411|"     The purpose of this study is to examine the drug-drug interaction in your body when given the     study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1     receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug     is and how well the study drug is tolerated when administered with exenatide injection.   "
9054|NCT03167398|"     Antibiotic resistance has emerged world wide and is of major concern. Multi-drug resistant     (MDR) bacteria is widely spread and is now a major factor in morbidity and mortality in     health-care settings. Among MDRs, carbapenem-resistant Enterobacteriaceae (CRE) are of     special concern, receiving the highest classification of urgent threat level in the US     President Report. Consistent mortality rates of 40-50% are observed among inpatients with     infections caused by CRE in hospitals worldwide, related mainly to unavailable, delayed or     ineffective antibiotic treatment options.      The extremely high mortality rates of patients with CRE infections have driven efforts to     prevent the acquisition and spread of these bacteria in hospitals. These include screening     for carriage, contact isolation of carriers, cohorting, dedicated healthcare staff and other     infection control measures. These strategies have been proven as effective but are cumbersome     and expensive. In most locations these strategies failed to completely eradicate CRE     endemicity.      CRE decolonization (eradication of colonization) might offer a double benefit - reducing the     risk for the individual carrier to develop an infection due to the resistant strain (by that,     potentially lowering the mortality risk) and preventing the bacteria from spreading to other     patients, exposing them to the same hazard.      Fecal microbiota transplantation (FMT), in which fecal material enriched with commensal     microorganisms is transferred from a healthy donor, have proven efficacy in the treatment of     recurrent Clostridium difficile infection (CDI) in multiple trails. Major adverse events that     has been reported so far are mostly related to the route of administration (aspiration during     nasogastric tube administration/colonoscopy). Other adverse events include mostly GI related     symptoms (diarrhea, nausea, belching) and are self limited and resolve in few hours. FMT     seems to be safe and effective both in immunocompetent and immunocompromised patients.      The high efficacy of FMT in the treatment of a multi-drug resistant pathogen such as     Clostridium difficile, suggest that it might be an efficient tool for other MDR pathogens     (e.g. CRE).      The authors aim to assess the effects of FMT on colonization and clinical infections with     CRE. The potential of FMT to restore the gut microbiome and compete with residual resistant     strains offer a novel way to fight the current MDR epidemic.      The authors will apply FMT on a cohort of CRE carriers in a single center in Israel. FMT will     be given by capsules for 2 consecutive days followed by rectal sampling at predefined     timepoint in the following 6 months.   "
9055|NCT03167385|"     This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with     with locally advanced or metastatic differentiated thyroid carcinoma (DTC). The purpose of     this study is to evaluate the efficacy and safety of apatinib in patients with locally     advanced or metastatic differentiated thyroid carcinoma.   "
9056|NCT03167372|"     This study compares the effect of two N-of-1 trials on study compliance with an N-of-1     protocol and on satisfaction with participation in an N-of-1 trial. Using within-person     analyses, the study also compares the effect of different types of light therapy on mood,     fatigue, sleep, physical activity, and side effects within a mild to moderately depressed     cancer survivor population. Twenty participants will be randomized to the bright white versus     dim red light therapyN-of-1 trial, while the remaining 10 participants will be randomized to     a dim white versus dim red light comparator N-of-1 trial.   "
9375|NCT03163225|"     The purpose of this research study is to determine whether there are things that     Intermountain can do to break down barriers to helping patients see their primary doctors or     other outpatient clinics. To do this we will develop and test a classification scheme to help     us understand how we might reduce some avoidable emergency department and InstaCare visits.   "
9063|NCT03167281|"     Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is     placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase     are given through the chest tube to help with draining the fluid. We are doing this research     to see if early addition of tPA-DNase immediately after chest tube placement will help with     better fluid draining.   "
9064|NCT03167268|"     Background and rationale: EGFR represents the main and more studied signal activation pathway     in the development of colorectal carcinoma. KRAS, NRAS, BRAF and PI3KA mutations and ERBB2     and MET amplification are responsible for most of the cases of primary resistance to     anti-EGFR antibody treatments. Despite the identification of these resistance mechanisms, a     primary resistance to the therapy was detected in a certain percentage of cases, in which     tumour bio-molecular characteristics would suggest a possible response to anti-EGFR antibody     treatment. In these cases, pathway activation mechanisms should exist, which act in an     alternative, complementary or parallel way than the EGFR one, allowing tumour progression     despite of EGFR pharmacological deactivation. Skin toxicity is a characteristic of drugs     having EGFR as a target and it shows itself mainly as a sterile acneiform folliculitis     together with neutrophils perifollicular infiltrates but also as skin xerosis and paronychia     starting from the earliest cycles of treatment. This skin toxicity seems to be closely     related to EGFR activation of pro-inflammatory cytokines able to activate specific     inflammatory activators, which induce neutrophils granulocytes chemotaxis. Lycopene is a     compound belonging to carotenoid group, largely contained in tomatoes and their derivatives,     which has an extreme antioxidant activity. In Dermatology, prolonged use of β-carotenoids in     general and of lycopene in particular in the diet showed to be effective in skin protection     from ageing, sunlight and radiotherapy damages because these compounds may accumulate in skin     and thus contribute to reduce free radicals and inflammation effects. Moreover, lycopene     ability to induce apoptosis and to inhibit cell cycle progression in some types of tumour     cells, both in vitro and in vivo, has already been described. Lycopene seems to be able to     suppress significantly PCNA (Proliferating cell nuclear antigen, cofactor of DNA     polymerase-β) and β-catenin nuclear expression in neoplastic cells, essential substrate of     WNT/β-catenin pathway, which is itself closely connected to activating pathways often     involved in carcinogenesis of some kinds of tumours, in particular of colorectal carcinoma,     like Akt/GSK3β/β-catenin and Hippo pathways. For its proved skin anti-inflammatory activity     as powerful free radicals scavenger, lycopene, which accumulates itself specifically in skin,     could be effective in reducing anti-EGFR drugs toxicity. Contemporary use of lycopene could     have a positive effect on anti-EGFR drugs treatment effectiveness in patients with metastatic     colorectal carcinoma due to its ability to interfere with pathways involved in neoplastic     cells proliferation.      Estimated population:100 patients (50 for each of the two groups of treatment)      Study Framework: In this study, patients suffering from metastatic colorectal cancer and     submitted to therapy with panitumumab would be enrolled. According to indications,     panitumumab would be used:      in first line combined with Folfox or Folfiri;      in second line combined with Folfiri or treatments containing Irinotecan      in monotherapy in any therapeutic line in patients resistant to Fluoropyrimidines,     Oxaliplatin and Irinotecan or intolerant to these drugs.      Standard schedules of these treatments would be used.      This is a phase-II, randomized, double-blind study between experimental prophylactic     treatment with Lycopene vs placebo:        -  Treatment A - lycopene tablets 20 mg        -  Treatment B - placebo tablets      Patients should take orally Lycopene/placebo after dinner (to promote its absorption),     starting the day before the beginning of treatment with panitumumab for the entire duration     of the therapy, until progression of the disease or definitive drug suspension for toxicity.      Objectives of the study      Primary objective: to assess the effectiveness of lycopene versus placebo in reducing skin     toxicity induced by panitumumab in patients treated for metastatic colorectal carcinoma.      Secondary objective: to assess lycopene pharmacokinetics      Exploratory objectives: to assess lycopene effectiveness versus placebo in increasing     panitumumab effectiveness in terms of Disease Control (DC), Objective Response (OR) and     Stabilisation of the Disease (SD). To assess lycopene effectiveness versus placebo in     increasing panitumumab effectiveness in terms of Progression Free Survival (PFS).      As far as randomization is concerned, the two groups will be balanced according to sex,     therapeutic line and institution in which patients will be treated.   "
9065|NCT03167255|"     This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once     weekly for an additional 24 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.   "
9280|NCT03164460|"     The goal of this research study is to compare the effectiveness of stereotactic body     radioablative therapy (SBRT) to conventional radiation therapy in patients with head and neck     cancer who are receiving repeat radiation.   "
9066|NCT03167242|"     This study aims to determine the most effective and tolerable dose at the shortest dosing     regimen of the investigational drug KAF156 in combination with a solid dispersion formulation     of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P.     falciparum malaria.      There is unmet medical need for anti-malarial treatment with new mechanism of action to     reduce probability of developing resistance, and for duration shorter than 3 days of     treatment and/or reduced pill burden.   "
9067|NCT03167229|"     Our goal is to determine the viral kinetics of HBV DNA reduction in 170 non-Thai pregnant     women receiving Tenofovir disoproxil fumarate (TDF) to inform a subsequent RCT. The     investigators also aim to determine adherence to daily TDF in pregnancy as new interventions     must not only be effective but also safe, feasible and acceptable in the local, and ideally     global, context.      Study Design: One arm, open label, Tenofovir treatment intervention study      Study Participants: Non-Thai pregnant women estimated gestation 12-20 weeks and their     offspring      Planned Sample Size: 170      Primary Objective To estimate the time to HBV DNA suppression (<100 IU/ml) in 170 HBV DNA     positive women who start TDF late in the first or early in the second trimester.      Outcome Measures Time in months to HBV DNA < 100 IU/ml      Secondary Objectives        1. To estimate the proportion of women with HBV DNA <100 IU/ml at delivery.        2. To estimate the TDF levels at delivery in women who are HBV DNA detectable and          undetectable.        3. To monitor safety of TDF in the Thailand-Myanmar border women        4. To address potential barriers to implementing TDF in early pregnancy to PMTCT-HBV.        5. To determine the rate of hepatic flares post-partum.        6. To estimate the proportion of cases of vertical transmission at 2 months of age.        7. Fetal growth monthly ultrasound, infant growth at 1,2,3,6,12 and neurodevelopment at 6          and 12 months   "
9069|NCT03167203|"     The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater     than 5 years after treatment) safety events of special interest in participants who have     received sub-retinal transplant of human embryonic stem cell derived - retinal pigment     epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special     interest are adverse events (AEs) that are presumed to have a potential causal relationship     to the hESC-RPE cells.   "
9070|NCT03167190|"     Although the lumbar puncture is a common procedure and has been performed without ultrasound     for decades, other research studies suggest that there may be some benefits to using     ultrasound. This study intends to see whether by using ultrasound there is increased success     rate, decreased need for additional procedures, and less discomfort during the procedure.   "
9071|NCT03167177|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with melanoma who have progressed on or after chemotherapy and     anti-PD-1/PD-L1 therapy.   "
9072|NCT03167164|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with MCC who have progressed on or after anti-PD-L1 therapy.   "
9073|NCT03167151|"     A parallel group, open label, multi-centre, phase I/II marker-lesion study of intravesical or     intravenous pembrolizumab in recurrent intermediate risk NMIBC. Thirty patients (fifteen in     each of two arms) will be randomised 1:1 to treatment with either intravesical pembrolizumab     (Arm A) or intravenous pembrolizumab (Arm B). The main study will be preceded by a single     institution safety run-in phase involving intra-patient dose escalation in six patients to     confirm the safety and tolerability of intravesical pembrolizumab and the dose to be used in     the randomised phase.   "
9074|NCT03167138|"     Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder     pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative     treatments such as pharmacological agents and physical therapy; however, when this fails,     rotator cuff surgery may be the only option. Autologous adipose tissue injection has recently     emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be     used to provide cushioning and filling of structural defects and has been shown to have an     abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose     of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose     tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons     with SCI.   "
9075|NCT03167125|"     The overall goal of this study is to test strategies to raise rates of colorectal cancer     screening among the Latino population in a federally qualified health center that operates     multiple clinics. This intervention study will test automated and live prompts to a     direct-mail fecal testing program in two phases.      In Phase I (Years 01 - 02), the investigators will tailor and define intervention components     using a community-based participatory research approach called boot camp translation (BCT).     The ultimate design of the intervention will be defined by patient and provider feedback from     BCT. The investigators will then conduct a three-arm patient-randomized trial to compare 1)     usual care, 2) automated screening prompts (e.g., automated phone calls, text messages,     patient portal messages) selected and refined by BCT [Automated Prompts], and 3) automated     screening prompts with culturally and linguistically tailored live prompts [Automated Plus     Live Prompts].      In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted     intervention to additional clinics within the partnering health center using a two-arm trial.      Both phases will be guided by an advisory group of clinicians, researchers, policy makers,     and patients.   "
12580|NCT03120767|"     The goal of this study is to evaluate the effect on first-year college students of     participation in a 14-week seminar course and residential housing wellness activities.   "
9133|NCT03166371|"     The purpose of this study is to see if oral liquid glutathione treatment, has any effect on     improving health-related cellular protection, muscle size and strength, and fatigue,     weakness, and quality of life in older adults with a history of malnutrition who have been     hospitalized. Persons enrolled in this study will be those initially admitted to Emory     University Hospital (EUH) in Atlanta, GA, but recovering and ready to be discharged home or     to an assisted living facility to eat an oral diet. A combination of nutritional measures,     blood markers and imaging tools will assess body composition. Study participants will     complete questionnaires about quality of life and physical health, and do simple testing for     physical strength and stamina. Information from this pilot study will increase understanding     of a simple intervention which may prevent or reduce health risks related to hospital     recovery in older adults.   "
9076|NCT03167112|"     Pancreatic cancer is a serious condition and is one of the leading cause of cancer related     health problem. It is estimated that in 2016, 5,200 Canadians will be diagnosed with     pancreatic cancer, and approximately 20% (1 in 5) of patients will have localized cancer     (cancer that is limited to pancreas and there is no evidence of cancer in other parts of the     body). Localized cancer is earlier stage of disease and surgery to remove the cancer is     standard of care in this condition. However, recent scientific and clinical studies show that     using the chemotherapy medication before surgery can improve the overall survival in patents     with localized pancreatic cancer. One of these chemotherapy regimen is combination of     fluorouracil, oxaliplatin, irinotecan, leucovorin (FOLFIRINOX) that we are going to evaluate     its effect in this study.      Because of promising result of this combination in more advanced stage of pancreatic cancer,     this study is going to examine its efficiency in earlier stage of pancreatic cancer     (localized form). Total number of participant in this study will be 20 patients with     localized form of pancreatic cancer without any evidence of cancer in other parts of the     body.      Laboratory tests show that it works by slowing down the growth of cancer or may cause cancer     cells to die. It is hoped that by shrinking the tumor size, the surgeon will be able to     remove the cancer and improve the overall survival.      Procedures start with 2 weeks of comprehensive evaluation. Approximately 20 eligible     subjects, based on this study criteria, will receive 6 treatment of this regimen every 2     weeks. Once 6 treatments have been completed, comprehensive re-evaluation procedures will be     repeated, and subjects without disease progression or unacceptable toxicity will continue on     their treatment based on treating team decision (surgical intervention, radiation therapy or     continue FOLFIRINOX or different regimen). Patients then will follow with CT scan, blood test     and physical examination every 3 months.   "
9077|NCT03167099|"     This study is designed to examine if immediate weight bearing on a distal femur fracture     fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less     invasive stabilization system), is safe and promotes more rapid fracture healing than partial     weight bearing, which is standard of care.   "
9078|NCT03167086|"     This study aims to compare the efficacy of a single session psychological treatment, From     Catastrophizing to Recovery (FCR), with the current standard of care, group Cognitive     Behavioral Therapy (CBT) specifically on individuals with chronic low back pain suffering     from Pain Catastrophizing (PC).   "
9079|NCT03167073|"     Breastfed babies have significant health benefits extending beyond infancy, including lower     rates of childhood obesity and infection. Low-income women are less likely to breastfeed     comparatively; this disparity may be due to misconceptions about breastfeeding benefits or     poor social support. Based on survey results and focus groups of low-income women, the     investigators designed a novel smart-phone application to confront barriers women perceived     prevented them from breastfeeding and propose the first-ever randomized controlled trial     describing the impact a smart phone app has on breastfeeding rates among low-income women.   "
9080|NCT03167060|"     This study will be a randomised placebo controlled trial examining the effectiveness of using     an intranasal evaporative cooling device (the RhinoChill intransal device) in providing     relief of pain and symptoms of acute migraine.The treatment works by introducing cooling into     the passageways of the nose through two small cannulas thereby cooling the local nasal tissue     and the blood vessels which supply blood to the brain. This cooling effect will cause the     blood vessels to constrict as well as stimulating special cold receptors that are thought to     be involved in the relief of migraine, thereby providing both pain and associated symptomatic     relief. In total, 90 patients randomised in a 1:1 fashio n will be recruited from three     different NHS Trusts. The patients will have a 30-day period of data collection for their     current migraine frequency, treatment and response to medication (with a minimum of 2     migraine attacks recorded) before starting the treatment phase with the RhinoChill Device.     Treatment will be for 3 migraine attacks. Only a single treatment is allowed for the first     attack, but on the second attack the patient may deliver 2 treatments with a gap of at least     2 hours between treatments, if indicated.   "
9081|NCT03167047|"     Two methods of pain control in children undergoing surgery on the groin and scrotum are     caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an     injection of local anaesthetic around the nerves supplying the area). A pilot study at our     hospital showed a significant decrease in post-operative pain and nausea and vomiting in     these two methods when compared to intravenous morphine and local anaesthetic to the wound.      One potential side effect from caudal injections is temporarily decreased motor power in the     legs due to the local anaesthetic - it is thought that this might be overcome using a more     dilute solution of local anaesthetic along with clonidine. This study is to demonstrate that     this method is as effective as the use of a regional nerve block.   "
9082|NCT03167034|"     This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right     ventricular function during exercise at acute altitude exposure in patients with COPD.   "
9083|NCT03167021|"     The objective of this survey will be to evaluate the perception by the students (except for     medical students, pharmacies) of community pharmacists concerning the management of cannabis     consumption. We want to see if the student population perceives the pharmacist as the public     health actor of choice, and if they would more easily turn to him or to another health     professional (doctor, nurse) in case they need. Discussing possible problematic consumption     or for a simple search for information. It will be assessed whether the pharmacist seems to     be a good candidate and an element of choice when young adults want to take an intelligence     approach to cannabis consumption.   "
9084|NCT03167008|"     -  Infertility is defined as the inability of a sexually active couple to conceive after 1          year of regular intercourse without contraception, affects approximately 15% of couples,          and male factors are the cause in 20% -50% of cases.        -  Infertility of unknown origin is classified into idiopathic male infertility and          unexplained male infertility according to semen quality.   "
9085|NCT03166995|"     In the current study, the investigators aimed to study:        -  The proprioception status of patients with FMS.        -  The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks          (2 sessions per week), compared to a low impact aerobic exercise program on different          parameters, such as proprioception, balance, muscle strength, flexibility and joint          range.   "
9131|NCT03166397|"     Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with     lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective     response rates of approximately 50 percent in patients with highly advanced, refractory     metastatic melanoma.      Recent developments in theTIL ACT procedure facilitate the use of a reduced-intensity,     non-myeloablative, lympho-depleting preparative regimen which is expected to be both less     toxic and equally efficient compared to previous regimens.   "
11020|NCT03141645|"     This study is designed to examine the incidence of postoperative nausea and vomiting during     24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative     intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor     ondansetron or control group (group C).   "
9086|NCT03166982|"     The treatment of the acute phase of the complicated abscess tubo-ovarian relies on     antibiotics more or less associated with surgical management in case of visible abscess, poor     clinical tolerance (sepsis) and resistance to medical treatment. The CNGOF recommended in     2012 that the tubo-ovarian abscess are not within one antibiotic, and should be drained by     interventional radiology, preferably by transvaginal or laparoscopic.      Furthermore the efficiency of drainage by ultrasound puncture performed vaginally was     demonstrated. This approach tends to replace the first laparoscopy because of its less     invasive, fast, easy to access, more acceptable and less cost compared to laparoscopy. This     approach is recommended by the French and English colleges.      In total, the surgery in case of ATO is necessary, it is always coupled with antibiotics.     Several surgical approaches are possible, laparotomy, laparoscopy and ultrasound-guided     puncture. No prospective comparative study has been done, for which we want to develop this     study.   "
9087|NCT03166969|"     Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor     stroke.      This study objective is to determine profitability of Holter 21 days for screening paroxystic     ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of     discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and     brain imaging (scanner and MRI) will be analyzed.   "
9088|NCT03166956|"     Background & Aims. Glutamine is a conditional essential amino acid that was found in reduced     plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and     vitamin C potentially have beneficial effects on wound healing and a reduction in infection     rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient,     and the associated changes in proinflammatory cytokines and clinical outcomes were     investigated.   "
9089|NCT03166943|"     It has been known for many years that the heart and the liver are intimately related. There     is a mutual interaction between the function of the heart and the liver and a broad spectrum     of acute and chronic entities that affect both the heart and the liver. Chronic hepatitis C     virus infection affects more than 3% (170 million) of the world's population.   "
9090|NCT03166930|"     This study will examine the impacts of two different methods of managing MS-related     spasticity of the lower limbs. Both interventions will be presented as group classes     consisting of exercises to reduce spasticity. One program consists of stretching exercises,     while the other consists primarily of range-of-motion and strengthening exercises.   "
9091|NCT03166917|"     Objective: Clinical application of 3D printing implant in bone defect treatment.      Study design: multicenter randomized controlled study . Methods:patients randomly grouped     according to register number into internal fixation and bone graft group and 3D printing     group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in     computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve     the greatest degree of physiological reconstruction.Evaluate surgical efficacy .   "
9092|NCT03166904|"     Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014).     Study-arm is composed of 27 patients.      Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using     RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8     weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective     disease progression (within a window of +/- 7 days of the scheduled date).   "
9093|NCT03166891|"     Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora     B）、VEGFR/PDGFR/c-Kit、CSF-1R targets. This clinical trial is studying the efficacy and safety     of chiauranib(50mg，QD，PO) works in treating patients with relapsed or refractory ovarian     cancer, in the meantime, exploring the latent biomarkers accompany with chiauranib, as well     as the relevancy of which and clinical benefit.   "
9094|NCT03166878|"     Autologous T cells engineered to express chimeric antigen receptors (CARs) against leukemia     antigens such as CD19 on B cells have shown promising results for the treatment of relapsed     or refractory B-cell malignancies. However, a subset of cancer patients especially heavily     pretreated cancer patients could be unable to receive this highly active therapy because of     failed expansion. Moreover, it is still a challenge to manufacture an effective therapeutic     product for infant cancer patients due to their small blood volume. On the other hand, the     inherent characters of autologous CAR-T cell therapy including personalized autologous T cell     manufacturing and widely distributed approach result in the difficulty of industrialization     of autologous CAR-T cell therapy. Universal CD19-specific CAR-T cell(UCART019),derived from     one or more healthy unrelated donors but could avoid graft-versus-host-disease (GVHD) and     minimize their immunogenicity, is undoubtedly an alternative option to address     above-mentioned issues. We have generated gene-disrupted allogeneic CD19-directed BBζ CAR-T     cells (termed UCART019) by combining the lentiviral delivery of CAR and CRISPR RNA     electroporation to disrupt endogenous TCR and B2M genes simultaneously and will test whether     it can evade host-mediated immunity and deliver antileukemic effects without GVHD.      The main goal of the phase 1 portion of this phase 1/2 trial is to evaluate the safety and     tolerability of several doses of UCART019 in patients with relapsed or refractory CD19+     leukemia and lymphoma, so as to establish the recommended dose and/or schedule of UCART019     for phase 2 portion. The recommended Phase 2 dose will be defined as the highest dose level     of UCART019 that induced DLT in fewer than 33% of patients (i.e., one dose level below that     which induced DLT in at least two of six patients). Phase 2 portion of the trial will not be     initiated until the recommended Phase 2 dose is determined. In the phase 2 portion of this     trial, we will mainly determine if UCART019 help the body's immune system eliminate malignant     B-cells. Safety of UCART019 and impact of this treatment on survival will also be observed.   "
9095|NCT03166865|"     Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic     degenerative disorder. There is no effective therapy available today. This prospective     clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with     platelet rich plasma in knee osteoarthritis.   "
9096|NCT03166852|"     High-intensity training (HIT) has showed beneficial effects in type 2 diabetics such as     improved glycemic control, improved bloodpressure and more. In addition, HIT is a time-saving     training protocol which is of importance, as lack of time often is mentioned as a reason not     to train. The combination of the time-saving HIT-protocol and the possibility to train at     home and still get feedback on the intensity and amount of training can be appealing for     some. This study aims to investigate whether it is possible to train at the right intensity     and frequency and only get feedback throug a technology.   "
9132|NCT03166384|"     There was no study about application of electrosurgical bipolar sealing device for mastectomy     in Korean population, because Korean national insurance did not cover use of the advanced     sealing device until last year. Sample size of the previous studies was too small to draw a     solid conclusion. Therefore, this study was designed prospectively to evaluate whether     application of bipolar energy device for mastectomy could provide clinical benefit in terms     of reducing seroma formation.   "
9097|NCT03166839|"     Background: Maternal deaths occur universally and are largely avoidable. Postpartum     haemorrhage accounts for a disproportionate amount of maternal deaths. There remains a great     need to expeditiously decrease the rate of postpartum haemorrhage to prevent further     mortality.      Methods: This study is a cohort analysis of data collected for the pragmatic international     multi-centre randomized double blind placebo controlled design WOMAN Trial. It will present a     univariate analysis of patient and delivery characteristics (age, type of delivery, placenta     fully delivered, primary cause of haemorrhage, severity of haemorrhage), physiologic     characteristics (systolic blood pressure, estimated blood loss, clinical signs of     haemodynamic instability) and management characteristics (receipt of blood products,     uterotonics). Multivariable logistic regression models and likelihood ratio tests will be     used to examine the evidence for interaction between death from PPH and region after     adjusting for any independent effects of 1) systolic blood pressure 2)age 3) type of delivery     4) receipt of blood products Discussion: This analysis of the WOMAN trial dataset will     explore the relationship between geographical location, patient and environment     characteristics and outcomes of postpartum haemorrhage. A protocol and statistical analysis     plan is presented here.   "
9098|NCT03166826|"     Apgar scoring system has been widely used for the evaluation of the infant's postnatal     condition. As conventional Apgar scoring system is affected by gestational age and     resuscitative efforts, there is a need for development of new scoring systems for the     assessment in the delivery room. Herein, Modified Combined Apgar scoring system which     includes two new parameters (cord blood pH and targeted oxygen saturation level) has been     developed and the utility of this modified system was compared with Conventional and Combined     Apgar scoring systems for prediction of hospitalization.   "
9099|NCT03166813|"     Survival rates of children with cancers have improved significantly in the recent few     decades. Nonetheless, the side effect of this class of drugs on heart function remains to be     an issue of concern. Exploration of new strategies to protect the heart in the long term is     therefore of paramount importance in children undergoing treatment of cancers. Previous     cardioprotective interventions hav focused on changing the formulation or rate of     administration of anthracyclines but with no observable benefits. While dexrazoxane, an iron     chelator, has shown to reduce cardiotoxic outcomes, there remains worries of an association     between dexrazoxane use and an increased risk of developing secondary malignancies. Recently,     the clinical application of remote ischaemic preconditioning (RIPC) as a non-invasive and an     easily applicable non-pharmacological myocardial protective intervention has gained     increasing interest. Remote ischaemic preconditioning is the phenomenon in which brief     episodes of reversible ischaemia and reperfusion applied to one vascular bed render     resistance to ischaemia reperfusion injury of tissues and organs distant away. It can be     achieved by repeated 5-minute cycles of inflation and deflation of blood pressure cuff placed     over the arm or leg to induce limb ischaemia and reperfusion injury. It is noteworthy that     anthracycline cardiotoxicity and myocardial reperfusion injury occur through similar     pathways. Hence, the investigators hypothesize that RIPC may reduce myocardial injury in     children receiving anthracycline chemotherapy for childhood malignancies. The proposed study     aims to conduct a parallel-group blinded randomized controlled trial study to investigate     whether RIPC may reduce heart damage in childhood cancer patients undergoing     anthracycline-based treatment, and to determine the effect of RIPC on the changes in levels     of cardiac troponin T, and on the occurrence of clinical cardiovascular events and     echocardiographic indices.   "
9100|NCT03166800|"     The purpose of this study is to determine whether MS patients who receive Oral mitoquinone     (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's     fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if     MitoQ has a significant change in fatigue.   "
9101|NCT03166787|"     Hookah (water pipe) smoking is a new global epidemic. The World Health Organization wants to     prohibit all claims that hookah is less harmful than cigarettes and wants hookah products to     bear the same warning labels as cigarettes. But there is little scientific evidence to     substantiate this proposal. Cigarettes, cigars, medicinal nicotine, and e-cigarettes all     acutely impair brachial artery endothelial function (flow-mediated dilation, FMD). Also,     cigarettes cause both acute and chronic impairment in coronary endothelial function, but the     comparative effects of hookah are unknown. Hookah tobacco is heated with burning charcoal.     So, the smoke contains tar and nicotine plus charcoal combustion products. These include     carbon monoxide (CO) and proatherogenic oxidants (especially carbon-rich nanoparticles) that     the study team expected to impair endothelial function.   "
9102|NCT03166774|"     Implementation of sexual health support program in oncology department. This program is     organized in 3 axes. One is to inform the side effects of treatment on sexual health.      There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with     patient and partner .      Finally, the oncologist continue during the treatment to evaluate the benefit of this program     and adapt their counselling according to the needs   "
9103|NCT03166761|"     Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in     sacroiliac joint injections   "
9104|NCT03166748|"     The purpose of this RCT is to compare the clinical/radiographic outcomes of Potassium nitrate     in polycarboxylate cement and MTA as pulpotomy biomaterials used for asymptomatic vital     immature permanent lower first molar and this will help to clinically evaluate the use of     alternative capping material in vital pulpotomy in young permanent teeth with pathologic     pulpal injuries emphasis is set on avoiding total pupectomy and maintaining radicular pulp     vitality and function and therefore maintain the tooth in a viable condition that help root     completion.   "
9105|NCT03166735|"     The primary objective of this study is the proof of mechanism and support of dose finding,     together with the safety evaluation in patients with clinical evidence of NASH.      To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory     analyses of biomarkers related to NASH and liver fibrosis will be performed. This will     include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP,     γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key     information regarding the use of BI 1467335 in patients with NASH.   "
9106|NCT03166722|"     The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival     without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral     tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and     heart rate and specified clinical treatment guidelines during immediate transition period     after birth (the first 15 minutes).   "
9107|NCT03166709|"     The goal of this study is to evaluate the effectiveness and utility of the investigator's     National Institute on Drug Abuse (NIDA) R21 developed Preventing Addiction Related Suicide     (PARS) program by utilizing a novel stepped wedge design to evaluate PARS as a selected     prevention program to increase help-seeking by clients in community addiction treatment.   "
9108|NCT03166696|"     A registry of consecutive patients who were admitted and diagnosed with acute myocardial     infarction or acute cerebral infarction were conducted at the Guangdong General Hospital or     the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Yue Bei People's     Hospital, China, between January 2000 and December 2016. The adverse clinical outcomes,     including all-cause mortality, were followed from the date of admission for acute myocardial     infarction or acute cerebral infarction until study end (December 31, 2016). All-cause     mortality, including the date of death, was identified from the electronic hospitalization     data, phone follow-up, and confirmed by the household registration (HUKOU) system, a record     of registration required by law in China. Baseline characteristics, including major treatment     of acute myocardial infarction or acute cerebral infarction, estimated glomerular filtration     rate (eGFR) and proteinuria, were collected. Demographic data were determined from the     electronic hospitalization data and electronic hospital discharge records. All comorbid     conditions were identified using International Statistical Classification of Diseases, Tenth     Revision (ICD-10), coding algorithms applied to electronic physician claims and electronic     hospital discharge records. Life style (smoking), treatment regimen at discharge, including     angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), were     determined from the electronic hospitalization data.   "
9109|NCT03166683|"     This multicentre prospective and randomized study aims to compare the sealant effect after     surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch     (Hemopatch) vs standard of care.   "
9110|NCT03166670|"     Diarrhea is one of the most common reasons for people to seek medical advice - but it can     range from being a mild, temporary condition, to be life threading condition. It is estimated     that there are 2 billion cases of diarrheal disease every year globally, and that 1.9 million     children below the age of 5 years, mostly in developing countries, die annually.   "
9111|NCT03166657|"     All women with history of secondary infertility after caesarean section will be subjected to     office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to     diagnose any subtle uterine abnormalities not detected by conventional means.      Hysteroscopic examination will be done during the proliferation phase of the menstrual cycle.      The hysteroscopic evaluation will include assessment of the cervical canal, intrauterine     lesions, the endometrium and the uterotubal junction. .      If hysteroscopy reveal a lesion, its type, size, location will be recorded. Transvaginal     ultrasound will be done after the procedure to detect fluid in the douglas pouch to confirm     patent tubes.      Asses the uterine scar in details.   "
9112|NCT03166644|"     To determine whether a treatment strategy targeting an individualized sufentanil     administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of     sufentanil during major abdominal surgery, as compared with standard practice.   "
9113|NCT03166631|"     The main objective of the dose-escalation parts of the trial is to determine the maximum     tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting     toxicities (DLTs), and/or the recommended dose for further development of BI 891065     monotherapy as well as of BI 891065 in combination with BI 754091, and to evaluate its safety     and tolerability by monitoring the occurrence and severity of adverse events (AEs).      Secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 891065     monotherapy as well as of BI 891065 in combination with BI 754091, and the preliminary     assessment of anti-tumour activity.   "
9114|NCT03166618|"     This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in     adult participants seeking correction of temple hollowing.   "
9115|NCT03166605|"     Wireless video capsule endoscopy (VCE) is a non-invasive technology that looks into small     intestine and gives images of its lumen as the wireless capsule passes through it. It is used     widely to access this anatomically difficult part of the body that cannot be seen via either     colonoscopy or endoscopy. Currently various studies have been done that give multiple     comparisons between various bowel preparation in terms of quality of the small bowel     visualization. No studies have been done where simethicone (Gas-X) is ingested after capsule     swallowing. We intend to give patients simethicone 1 hour after capsule ingestion for two     consecutive hours and compare results of capsule endoscopy outcomes like small bowel transit     time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ) and completion     rate (CR).   "
9116|NCT03166592|"     Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of     intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra     axial brain masses can be non-specific and even the use of contrast agent is of limited     benefit.      Contrast enhancement reflects only disruption of blood brain barrier. One third of high-grade     malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement.      Reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade     from low grade tumor, is difficult with conventional Magnetic resonance imaging   "
9117|NCT03166579|"     This study aims to evaluate the effectiveness of Dialectical Behaviour Therapy for adults     with Borderline Personality Disorder attending Community Mental Health Services in Cork,     Ireland.      The main objective of the current study is to determine if completion of a 12 month DBT     programme is associated with improved outcomes in terms of borderline symptoms, anxiety,     hopelessness, suicidal behaviour, depression and quality of life.      A secondary objective includes assessing client progress across multiple time-points     throughout the treatment.   "
9118|NCT03166566|"     Purpose: To assess the feasibility of a surgical technique and present the preliminary safety     results of a new glaucoma device devoid of a tube in painful blind eyes.      Methods: Fifteen end-stage glaucomatous eyes without light perception vision were treated     with a novel laminar drainage implant. Intraocular pressure was measured preoperatively and     up to 24 months after surgery using a Goldmann applanation tonometer. A scale ranging from 0     to 10 was used to evaluate ocular pain. Conjunctival hyperemia, discharge, erosion or     retraction, aqueous humor leakage, corneal edema, hyphema, anterior chamber cells and depth,     dislocation of the implant, and filtering bleb height were assessed by slit-lamp     biomicroscopy. Anterior segment optical coherence tomography was also assessed.   "
9119|NCT03166553|"     Clinical Trial of Elemene Injection/Elemene Oral Emulsion in Combination with Systematic     Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver     cancer   "
9120|NCT03166540|"     The aim of this study will be to define the bioavailability and the beneficial properties of     coffee bioactive compounds. Moreover, the contribution of cocoa-based products containing     coffee to the pool of circulating metabolites will be investigated with the aim of evaluating     the effect of the combination of bioactives from different sources.      To study the bioavailability of coffee/cocoa bioactive compounds and their effects in     cardiometabolic health, the objectives will be:      i) Assessing the bioavailability of the four main groups of phytochemicals in roasted coffee     (methylxanthines, phenolic compounds, trigonelline, and diterpenes), its modulation by the     level of consumption, and establishing the daily average concentration of coffee-derived     plasma circulating metabolites; ii) Investigating the effect of different levels of coffee     consumption on cardiometabolic risk factors; iii) Evaluating circulating metabolites and     their putative bioactivity when substituting coffee consumption with the intake of     cocoa-based products containing coffee.      A 3-arm, crossover, randomized trial will be conducted. Twenty-one volunteers will be     randomly assigned to consume three treatments in a random order for 1 month: 1 cup of     espresso coffee/day, 3 cups of espresso coffee/day, 1 cup of espresso coffee at breakfast and     2 cocoa-based products containing coffee two times per day. The last day of the treatment     subjects will refer to the ambulatory where blood and urine samples will be collected at     specific time points up to 24 hours following the consumption of the testing coffee or of the     cocoa-based products containing coffee. In addition to the bioavailability of the bioactive     compounds, the effect of the coffee consumption on several cardiometabolic risk factors     (blood pressure, anthropometric measures, inflammatory markers, nitric oxide, blood lipids,     fasting indices of glucose/insulin metabolism, DNA damage, eicosanoids, nutri-metabolomics)     will be investigated. At the end of the treatment, the same protocol will be repeated,     switching the allocation group.   "
9121|NCT03166527|"     Chronic inflammatory demyelinating polyneuropathy (CIDP) is a treatable form of peripheral     neuropathy with suspected autoimmune cause. The current first-line treatment is IVIG (immune     globulin), which is infused in a set regimen that requires 4-5 hours in a hospital day unit,     taking up resources such as nursing time and hospital space. Chronic treatment is required in     most cases.   "
9122|NCT03166514|"     The purpose of this study is to examine the glucose and insulin response to a food bar.   "
9123|NCT03166501|"     This Phase 1b study examines the safety and efficacy of parenterally-administered lanicemine     in a parallel-arm, randomized, double-blind, placebo-controlled trial in adult patients     (N=24) with significant PTSD symptoms and elevated anxiety potentiated startle (APS).     Investigator hypothesize that lanicemine (100 mg) displays a normalization of APS following     three infusions over 5 non-consecutive days. If target engagement is demonstrated and the     drug is safe and tolerable in this patient population, investigator will proceed to a larger     POC study.   "
9124|NCT03166488|"     The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic     Resonance Elastography (MRE). The study will let the investigators know whether the subject's     liver is normal or has increased stiffness. Increased liver stiffness often means there is     chronic liver disease and fibrosis. Increased right heart pressure and congestive heart     failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if     progressive, may lead to cirrhosis and its related complications. The increased liver     stiffness may be due to a poorly functioning tricuspid valve. With this research, the     investigators will be able to determine if the elevated stiffness of the liver returns to     normal after the surgeon performs a repair or replacement of the tricuspid valve.   "
9125|NCT03166475|"     A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the     UFJF was conducted. It was included patients who presented indication of extraction of     premolars, canines or incisors. All the thirty patients underwent dental extraction and were     randomly divided into three groups according to the study methodology. Plaster casts and     Cone-Beam Computed Tomography (CBCT) exams were performed for comparative analysis between     sample groups and between study times ( imediate postoperative and four months later).   "
9126|NCT03166462|"     Demand for Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) is increasing     steadily and is projected to continue trending upwards in the coming years. Concomitant with     that trend is the increase in prevalence of obesity. Obesity serves as a common risk factor     for osteoarthritis, obstructive sleep apnea and medical complications.      Obstructive Sleep Apnea (OSA) is defined as episodes of obstructive apneas and hypopneas     during sleep, with daytime somnolence. It occurs commonly in obese, middle age and elderly     men and has an estimated prevalence of 5% - 9%.      Pre-operative screening for elective surgical procedures is a critical component of a     successful surgical outcome. Patients with medical comorbidities ideally will undergo medical     treatment or optimization to minimize the risk peri-operatively and post-operatively.     Obstructive sleep apnea has been shown in numerous studies to be a risk factor for     cardiopulmonary complications following surgery. The contributing factors include alterations     in REM sleep post-operatively and opioid induced respiratory suppression post-operatively.      The STOP-BANG patient questionnaire is a validated patient survey that uses both objective     and subjective data to screen patients for their risk of OSA. The sensitivity of the     STOP-BANG questionnaire for moderate-to-severe OSA has been estimated as high as 97.74%.     Authors have also shown that higher STOP-BANG scores are independently associated with     increased risk for post-operative complication.      Other authors have utilized similar pre-operative questionnaires to screen for occult     pulmonary disease in patients scheduled for elective joint arthroplasty. They found a     slightly increased incidence of OSA in this population as compared with the national average,     over 50% of which were previously undiagnosed.      The American Society of Anesthesiologists task force on perioperative management of patients     with OSA published extensive guidelines aimed at reducing morbidity and mortality. Improved     diagnosis pre-operatively could aid in proper compliance with these guidelines. These     recommendations include preferential use of regional analgesia, reduction in systemic     opioids, monitoring of oxygen saturation and nonsupine posture.      The mainstay of treatment for OSA is a positive pressure airway device such as Continuous     Positive Airway Pressure (CPAP) or in severe cases Nasal Intermittent Positive Pressure     Ventilation (NIPPV). Post-operatively continuation of these treatments in patients with known     OSA is often recommended. Some authors have demonstrated reductions in Apnea-Hypopnea Index     postoperatively through the use of CPAP.      However, a recent meta-analysis evaluating the effect of pre-operative or post-operative CPAP     in patients with OSA concluded that the use of CPAP did not reduce post-operative adverse     events.      Given the projected increase in demand for joint arthroplasty, the ever-increasing incidence     of obesity, the ambiguity surrounding the topic and the potential to clinically impact     post-operative morbidity, mortality and health care costs, shows the need for further     studies.   "
9127|NCT03166449|"     Background: Head injury is one of the top three diagnosis leading to intensive care unit     (ICU) admission in Malaysia. There has been growing interest in using immunonutrition as a     mode of modulating the inflammatory response to injury or infection with the aim of improving     clinical outcome. The aim of the present study was to evaluate the effect of an     immunonutrition on biomarkers (IL-6, glutathione, CRP, total protein and albumin) in     traumatic brain injury patients.      Methods: Thirty six patients with head injury admitted to neurosurgical ICU in University     Malaya Medical Centre were recruited for this study, over a 6-month period from July 2014 to     January 2015. Patients were randomized to receive either an immunonutrition (Group A) or a     standard (Group B) enteral feed. Levels of biomarkers were measured at day 1, 5 and 7 of     enteral feeding.      Results: Patients in Group A showed significant reduction of IL-6 at day 5 (p<0.001) with     concurrent rise in glutathione levels (p= 0.049). Patients in Group A also demonstrated a     significant increase of total protein level at the end of the study (day 7).      Conclusion: These findings indicate the potential of immunonutrition reducing cytokines and     increasing antioxidant indices in patients with TBI. However, further studies incorporating     patient outcomes are needed to determine its overall clinical benefits.   "
9128|NCT03166436|"     Pancreatic cancer and cholangiocarcinoma are the most common causes of malignant biliary     obstruction. They are diseases of increasing incidence and unfavorable prognosis. Only a     minority of patients have a localized disease and are indicated for surgery with a chance of     long-term survival. Locally advanced and metastatic tumors are treated with palliative     chemotherapy or chemoradiotherapy; the results of such treatments are unsatisfactory. The     average survival of patients with unresectable disease is 6 months and only 5 - 10 % of     patients survive 5 years. Chemotherapy and radiotherapy can be used, however only with a     palliative effect. Biliary drainage is an integral part of palliative treatment.     Endoscopically or percutaneously placed stents improve quality of life, decrease cholestasis     and pruritus, but do not significantly improve survival. Biliary stents get occluded over     time, possibly resulting in acute cholangitis and require repeated replacement. Endoluminal     biliary photodynamic therapy (PDT) and radiofrequency ablation (RFA), locally active     endoscopic methods, have been increasingly used in recent years in palliative treatment of     patients with malignant biliary obstruction. In photodynamic therapy, improved survival has     been shown in two randomized controlled trials; however the technique suffers from technical     complexity, high cost and low availability. In RFA, application of low voltage high frequency     current during radiofrequency ablation results in tissue destruction by heat. Its antitumor     effect may also be related to systemic changes in antitumor immunity. The use of endoluminal     biliary RFA has so far been reported only in small retrospective cohorts of patients.      The aim of this randomized study is to compare efficacy of RFA plus stenting to stenting     alone in palliative treatment of malignant biliary obstruction with survival as primary     outcome. Secondary outcomes are stent patency, immediate and late complications, quality of     life and effects on anti-tumor immunity in the RFA group.   "
9129|NCT03166423|"     The primary objective is to evaluate the efficacy and safety of the use of a formulation of     snail slime and natural extracts, for the curative treatment of ulcer wonds in diabetic foot.      The secondary objetives:        1. To evaluate the efficacy of the use of a formulation of snail slime Helix aspersa Müller          and natural extracts (MU001) for the curative treatment of ulcer wonds in diabetic foot          with respect to the standard of care, by means the application of patchs that containing          the formulation in a treatment period of until 60 days.        2. To determine the safety of the use of a formulation of snail slime Helix aspersa Müller          and natural extracts (MU001) in diabetic individuals in a treatment period of until 60          days.   "
9138|NCT03166306|"     Pulmonary arterial hypertension (PAH) is a disorder of elevated pulmonary vascular resistance     characterized by progressive remodeling and obliteration of vessels of the distal pulmonary     circulation. Outcomes in PAH could be improved with earlier diagnosis, and with the early     deployment of therapies before irreversible changes have occurred. This study tests the     sensitivity of positron emission tomography (PET)-CT scanning with [89Zr]-bevacizumab, a     radioisotope-conjugated anti-VEGF antibody for detecting pulmonary vascular remodeling in PAH     disease. This test could enable non-invasive diagnosis early in the course of the disease,     and potentially improve outcomes in PAH,   "
9139|NCT03166293|"     This is a randomized controlled trial comparing 3 months of intensive leg exercise to     standard physiotherapy care for the improvement of motor function in the legs in young     children with spastic diplegia.   "
9140|NCT03166280|"     HCV is associated with vitamin D deficiency. Iron overload is frequently occurred in chronic     hepatitis C patients; more than one third of HCV positive patients have elevated serum iron,     ferritin, and transferrin which were linked to bad prognosis. Hepcidin is a regulatory     peptide that is mainly synthesized by the liver cells and plays an important role in iron     homeostasis. There is an interaction between iron metabolism and vitamin D metabolism. Iron     is essential for vitamin D activation and vitamin D deficiency is associated with elevated     hepcidin level, which partly accounts for anemia associated with vitamin D deficiency. Up to     our knowledge, little is known about the association between vitamin D status and iron     metabolism in HCV patients.   "
9141|NCT03166267|"     In this prospective case series patients with a tibial fracture are monitored with smart     biofeedback systems to document the healing progression and real life weight.   "
9142|NCT03166254|"     Metastatic non-small cell lung cancer (NSCLC) is incurable with current therapies, but due to     mutations induced by cigarette smoke, typically expresses a large number of altered proteins     that can be recognized as foreign by the immune system. This antigenicity is thought to     explain the efficacy of pembrolizumab as either a first or second line treatment in this     disease. For patients who receive chemotherapy as a first line therapy, there is sound     rationale for combination treatment with immunotherapy and a therapeutic antitumor vaccine as     a maintenance strategy. Regardless of PD-L1 expression in the tumor, monoclonal antibodies     that block PD-1/PD-L1 interactions are effective second line therapies after chemotherapy. In     addition, by targeting the immune system against tumor specific antigens using a peptide     vaccine, the efficacy of pembrolizumab alone is expected to be enhanced, with an improved     response rate and prolonged overall survival with no additional toxicity.      This pilot study will provide a preliminary test of the feasibility of generating a     personalized, tumor neoantigen-specific therapeutic vaccine and the safety of combining it     with checkpoint blockade immunotherapy.   "
9143|NCT03166241|"     Adverse cutaneous drug reactions are undesirable and typically unanticipated reactions     independent of the intended therapeutic purpose of a medication. It may be either immunologic     (eg, drug allergy) or non-immunologic. Adverse cutaneous drug reaction produce a wide range     of clinical manifestations such as pruritus, maculopapular eruptions, urticaria, angioedema,     phototoxic and photo allergic reactions, fixed drug reactions, erythema     multiforme,vesiculobullous reactions (eg, Stevens-Johnson syndrome and toxic epidermal     necrolysis) and serum sickness .They must be considered in the differential diagnosis of     sudden symmetric eruption   "
9144|NCT03166228|"     Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical     lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis     of a vast number of uterine pathologies Historically, urologists used the resectoscope to     perform a transurethral prostatectomy. This instrument was later modified to accommodate     gynaecological applications. Operative hysteroscopy became popular after improvements in     endoscopic technology and instruments in the 1970s and after the introduction of fluid     distension media in the 1980s (1). During the past 2 decades, hysteroscopy has been     increasingly used for operative procedures   "
9145|NCT03166215|"     The purpose of this study is to characterize the multiple-dose safety and tolerability     profile of TAK-935 in adult participants with developmental and/or epileptic     encephalopathies.   "
9376|NCT03163212|"     This study will examine the safety and tolerability of supplementation with bovine     lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants.     Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature     and healthy gut. It also has antimicrobial and immunomodulation activities.   "
9146|NCT03166202|"     Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising     candidate as a functional endpoint measure for evaluating interventions to slow early     progression of age-related macular degeneration (AMD). However, there is no agreement among     the clinical, research and regulatory communities as to what constitutes a clinically     (practically) significant slowing in RMDA. Treatments for AMD are often not considered     efficacious if they do not result in a criterion level of improvement in vision. But how much     change in the rate of dark adaptation constitutes a clinically significant change? Until this     issue is resolved, progress in developing clinical trials on early AMD are at a standstill     since there is no functional endpoint to be used in the trial. One approach to establishing     clinical significance is to examine how RMDA relates to the performance of an everyday visual     task under low luminance conditions, such as night driving or reading. However, such data are     not yet available. The purpose of this project is to examine the relationship between RMDA     and night-time driving and reading under poor illumination. This information will guide the     development of a definition of a clinically significant difference in RMDA that can be used     in designing clinical trials on early AMD.   "
9147|NCT03166189|"     Investigators will examine safety and efficiency of the cell product of autologous bone     marrow-derived mesenchymal stem cells (MSC) for patients with repeated IVF failures and     hypoplastic or/and fibrosis process of endometrium   "
9148|NCT03166176|"     Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014)     monotherapy. Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous     schedule of a 28 day cycle as a monotherapy   "
9149|NCT03166163|"     i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on     bleeding on brushing among a group of Egyptian children.   "
9153|NCT03166111|"     Long-acting reversible contraception methods are highly effective methods for reduction of     the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that     provides reliable, effective and long term contraception for many women. However, the     insertion procedure can be associated with a troublesome degree of pain that prevent some     women from choosing its use. Different interventions have been described to decrease pain     perception during intrauterine device insertion with no agreement on an effective one.     Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and     prostaglandins has been reported with variable degrees of success .   "
9154|NCT03166098|"     This is a single center study that uses both between-group comparisons and correlational     analyses to establish biomarkers of dysmyelination and cognitive impairment in Psychotic     Spectrum Disorders using imaging and neuropsychological assays.The study will provide     non-invasive biomarkers of cognitive dysfunction in Psychotic Spectrum Disorder.   "
9155|NCT03166085|"     The purpose of this study is to decide the best dose of the study drug, PU-H71, that can be     given in combination with the standard chemotherapy drug, nab-paclitaxel (Abraxane).   "
9156|NCT03166072|"     To evaluate health related quality of life (HRQoL) of low-vision patients and their care     givers undergoing low-vision rehabilitation program (LVRP).   "
9157|NCT03166059|"     The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce     bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb     ischemia. This device has been designed to protect the puncture site by stabilizing the CDT     sheath with the double-balloons that are part of the CaveoVasc system. Also the device is     designed to reduce bleeding at the puncture site during CDT.      This study is designed to assess the safety and performance of the CaveoVasc Thrombolysis     Protection System in twenty patients with limb ischemia undergoing treatment with CDT.   "
9158|NCT03166046|"     Chronic pain is now widely understood to be due to central sensitization, which leads to     exaggerated pain perception. Migraine is no exception, since it is well known that     sensitization of the trigeminovascular pain pathway can occur during a migraine attach. There     is early evidence that ActiPatch can help mitigate this sensitization, so this study is being     conducted to determine the efficacy of ActiPatch in preventing chronic, episodic migraines.   "
9159|NCT03166033|"     This study is conducted to observe the characteristics of the risk factors of CTS in Chinese     population.   "
9160|NCT03166020|"     The aim of this randomized controlled study with stroke patients is to demonstrate that a     re-education with interactive table with instrumented objects delivering sensory feedback and     serious game improve certain motor functions of the paretic upper limb than rehabilitation     based on a standardized self-rehabilitation program.   "
9161|NCT03166007|"     The aim of the AMBER trial is to determine the effectiveness and cost effectiveness of     abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who     have problems with their bowel i.e. faecal incontinence and/or constipation.   "
9162|NCT03165994|"     This study evaluates APX005M, in combination with chemoradiation, in patients with resectable     cancers of the esophagus and gastroesophageal (GE) junction, including both squamous cell and     adenocarcinomas.   "
9195|NCT03165565|"     The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral     intervention strategy promotes treatment entry and reduces risk of additional     substance-exposed pregnancies (SEPs), as well as HIV and HCV risks among substance-using NICU     mothers. Additionally, to assess whether the intervention increases use of professional     obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies     (SEPs).   "
9163|NCT03165981|"     A prospective, randomized open-label clinical trial that will be conducted during the     2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be     enrolled at Duke University Medical Center and Kaiser Permanente Northern California.     Eligible children will be randomized to receive simultaneous or sequentially administered US     licensed PCV13, US-licensed DTaP vaccine, and US-licensed inactivated influenza vaccine     (IIV). Children in the simultaneous group will receive PCV13, DTaP, and IIV vaccines at Visit     1, and then return for a health education visit without vaccination about 2 weeks later     (Visit 2). Children in the sequential group will receive both PCV13 and DTaP without IIV at     Visit 1, and then will receive IIV and health education about 2 weeks later (Visit 2).     Parents will record the occurrence of fever, solicited adverse events, medical care     utilization, and receipt of antipyretics over 8 days following Visit 1 and Visit 2. In     addition, febrile seizures and serious adverse events will be recorded for the entire study     period (from enrollment through 8 days following the Visit 2) as determined through parental     report and chart review. Parental perceptions about their child's vaccine schedule will be     assessed on the 8th day following Visit 2.   "
9164|NCT03165968|"     The long term goal for the Traumatic Injury Research Program (TIRP) is testing of novel     devices for the identification and longitudinal assessment of traumatic brain injury (TBI).     The Department of Defense (DoD) has now tasked TIRP with the test and evaluation of these     devices to assess reliability and validity. The objective of this effort is to test the     reliability of the NeuroKinetics Inc (NKI), i-PAS (portable assessment system) device using a     test/re-test protocol with healthy controls.      The basic research design adopted here is the test/re-test paradigm with three assessments     obtained on three separate visits. This will allow the assessment of reliability of both the     device and the measure(s) that are computed from the input signals. Participants will be     Healthy Controls (HC) as defined in the inclusion exclusion section.      In this initial study we will be administering standardized self-report instruments ( Short     Form - 36 (SF-36) and the Symptom Checklist-90 (SCL-90r)), standard three-lead     electrocardiogram. In addition we will administer the NKI i-PAS specific protocol as     delineated by NKI.   "
9165|NCT03165955|"     This is a multicenter, open-label, single-arm PK study in patients for whom paclitaxel     treatment is indicated.   "
9180|NCT03165760|"     Randomized controlled trial, comparing two groups of 40 patients each scheduled for open     major abdominal surgery. The intervention group was ventilated with a protective strategy     consisting on a low Tidal volume (Vt) (6ml/kg of predicted body weight (PBW)), positive end     expiratory pressure (PEEP) = 10 cm H2O and recruitment manoeuvres (RM) after disconnection     from the ventilator, the control group had classic ventilation (Vt = 8 ml/kg of PBW, PEEP = 4     cmH2O and no RM).   "
9166|NCT03165942|"     This study proposes to examine both the peripheral and central nervous system responses when     light social drinkers and binge/heavy social drinkers are exposed to intravenous infusion of     ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral     blood flow and functional connectivity) underlying the association between stress, cortisol     release, heart rate variability, alcohol craving, and alcohol stimulant and sedative effects.     This knowledge could be significant in developing new therapies for the treatment of     alcoholism.   "
9167|NCT03165929|"     Connective tissue graft (CTG) and free gingival graft (FGG) harvesting from the palatal area     has been used frequently in the periodontal mucogingival surgery and reported to provide     higher predictability and success regarding esthetic outcomes. The aim of the study was to     evaluate the effects of oral flurbiprofen spray on wound healing, postoperative patient     morbidity and discomfort after palatal graft harvesting.      Forty eight patients scheduled for CTG and FGG requiring periodontal plastic surgeries were     selected. The patients were randomly assigned to each group, and used oral spray of     flurbiprofen or placebo 3 times a day for a week. The palatal donor area was evaluated at 1     and 3 days and 1, 2, 3, 4, 6 and 8 weeks postsurgery for postoperative pain, complete     epithelization, feeding habits, color match, and total number of analgesic pills taken. The     Wound-Healing Index (WHI) was recorded at 2-week follow up.   "
9168|NCT03165916|"     A randomized prospective study will be conducted of patients at Vanderbilt University Medical     Center who undergo liver transplantation from March 2014 until approximately 120 patients are     randomized. Patients will be randomized to undergo biliary reconstruction with and without     stent placement.   "
9169|NCT03165903|"     The study tested an intervention that used a cue-removal and implementation intentions based     strategy to change habitual dietary behaviors. The intervention was evaluated using a     randomized experimental design that consisted of two conditions including (1) a control     condition or (2) a cue and implementation intention-based intervention. High schools (N=22)     were randomly assigned to one of the two conditions. Families (N=187), with a family defined     as an adolescent and one participating parent, were recruited from within the 22 schools. All     of the families from each school were assigned to the same condition.      Families that were eligible for the study and that were interested in participating scheduled     an appointment to complete informed consent. After written parental consent and youth assent     was obtained, the participants had their height and weight measured and completed a series of     questionnaires programmed on laptops. In addition, the adolescent took part in a 24 Hour     Dietary Recall Assessment. The family was also informed that a second 24 Hour Dietary Recall     Assessment would be administered to the adolescent over the phone in approximately 3-14 days.      Families that were from a school assigned to the control condition received an intervention     on sun safety that consisted of a 10-minute meeting with a trained Health Coach, two generic     newsletters, an email, and a text message. Families from a school assigned to the cue- and     implementation intentions condition received an intervention on healthy snacking and the     reduction of sugar sweetened beverage consumption that consisted of a 90-minute meeting with     a trained Health Coach, two 20-minute phone calls, four tailored newsletters, and a series of     emails and text messages. Both of these interventions were delivered over a period of 3-10     weeks depending on the self-directed pace of the participants. All participants were then     asked to complete a follow-up assessment appointment three months after their original     consenting appointment. Our hypotheses focused on dietary behaviors and stated that     adolescents assigned to the cue-removal and implementation intentions intervention would     consume significantly fewer daily servings of high fat snacks, high sugar snacks, and sugar     sweetened beverages than adolescents in the control condition.   "
9170|NCT03165890|"     Randomized, placebo controlled trial evaluating the effect of acetazolamide on cognition in     lowlanders with chronic obstructive pulmonary disease travelling from 760 m to 3200 m.   "
9171|NCT03165877|"     To compare the effect of low-glycemic index versus control lunches and dinners intake on     indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2     diabetes under metformin therapy.   "
9172|NCT03165864|"     The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of     IONIS TMPRSS6-Lrx Administered Subcutaneously to Healthy Volunteers   "
9173|NCT03165851|"     The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for     pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a     risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes     of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.   "
9216|NCT03165292|"     The main objective is to evaluate the efficacy of two intensified consolidation strategies in     very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from     randomisation date. This evaluation will follow a hierarchical testing procedure: each     experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of     positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.   "
9174|NCT03165838|"     Due to potential to improve family planning, clinicians are increasingly interested in     shortening the time to postpartum visits, but lack an evidence base to change policy.There     are no studies that have examined the effectiveness of shortened interval to postpartum visit     on attendance rate, contraception use, and rapid repeat of pregnancy (RROP). With this     research, the investigators propose to conduct a randomized controlled trial (RCT) to examine     the effect of reduced time interval to postpartum visit (3-4 weeks rather than 6-8 weeks) on     postpartum visit attendance rate, contraceptive use, and RROP.   "
9175|NCT03165825|"     compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical     transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain   "
9176|NCT03165812|"     The incidence of diabetes mellitus is increasing annually in Asia. It is the leading cause of     blindness, chronic renal insufficiency, and amputations, multiplying the risks of heart     disease and stroke. Ninety percent of diabetic patients are type 2 diabetes mellitus (T2DM),     which is usually associated with overweight and obese. Single Anastomosis Duodeno-Jejunal     Bypass with Sleeve Gastrectomy (SADJB-SG) is a type of bariatric surgery whereby food is     bypassed into the distal jejunum, and the duodenum is excluded. Sleeve gastrectomy offers the     restrictive component by reducing the capacity of the stomach. In short, this combined     technique results in food restriction and malabsorption. A total of 84 patients will be     recruited in this study. An equal number of patients will be allocated into two groups. There     will be an intensive medical therapy group (IMT) and SADJB-SG group. The patients in IMT     group will be subjected to strict adherence to diet, optimization of diabetic medications and     close monitoring of blood glucose and glycated haemoglobin (HbA1c) level. The SADJB-SG group     will be undergoing surgery. The variables that will be studied include body mass index (BMI),     fasting blood glucose (FBG), glycated haemoglobin (HbA1c), C- peptide, plasma insulin and     Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Biochemical markers are     important in this research as the development of T2DM involves both multi-organ insulin     resistance and inadequate insulin secretion by pancreatic β-cells, leading to high blood     sugar during fasting and post meal. Other mechanisms proposed in this study are leptin,     adipokines, incretins, amino acids, and diabetic dyslipidaemia. The raw data will be analysed     using the SPSS statistical software. At the end of the study, the investigator will evaluate     and determine the role of SADJB-SG in glycaemic control and BMI in T2DM patients compared to     IMT. The investigator hypothesized that there is an improvement in HbA1c level in T2DM     patients in SADJB-SG group compare to IMT group.   "
9177|NCT03165799|"     This is a single center, randomized study that assessed the effects of mindfulness training     on physician teaching teams at a VA hospital.   "
9182|NCT03165734|"     This is a Bayesian adaptive dose-finding study in patients with primary or secondary     myelofibrosis:        1. who have failed therapy with ruxolitinib on the basis of intolerance or loss of          efficacy,        2. are thrombocytopenic (platelet count of ≤100,000/μL),        3. highly symptomatic (DIPSS risk score of Intermediate-1 to High Risk),        4. and have splenomegaly (assessed by physical examination).      The study is designed to support a pacritinib dosage selection decision. Three dosages will     be evaluated, with patients randomized 1:1:1 to pacritinib 100 mg quaque die (QD), pacritinib     100 mg bis in die (BID), or pacritinib 200 mg bis in die (BID). Assigned treatment will     continue for 24 weeks unless the patient experiences progressive disease, intolerable AEs,     withdraws consent, or until the assigned treatment arm is closed. All patients should     complete all visit procedures through Week 24, including patients who stop pacritinib     treatment or have protocol-defined progressive disease prior to Week 24, unless patient     withdraws consent, dies, undergoes splenic irradiation or splenectomy, or initiates any     nonprotocol-directed anti-myelofibrosis treatment. The dosage selection process will be based     on pre-specified efficacy and safety parameters, including model-based dose-response. The     maximum duration of trial participation for an individual patient will be approximately 7     months. The estimated duration of the entire study is approximately 2 years if the maximum     number of patients are enrolled.   "
9193|NCT03165591|"     Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of     cancer-related death in the United States, with a survival rate of less than 7%.There are     currently no treatments found to be effective for patients with advanced disease who are     ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses.     Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving     patients with practically no options except surgery.      We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients     with PDA in line with similar highly promising approach we have adopted for patients with     hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given     one tablet per day of V3-P and followed up to see the outcome.   "
9183|NCT03165721|"     Background:      Wild-type gastrointestinal stromal tumor (GIST) is a cancer in the esophagus, stomach, or     intestines. It does not respond well to standard chemotherapy or radiation therapy. Most     people with GIST are treated with imatinib. But it may not work in many children with GIST.     Researchers think the drug SGI-110 may help treat people with GIST, pheochromocytoma and     paraganglioma (PHEO/PGL), or kidney cancer related to hereditary leiomyomatosis and renal     cell carcinoma (HLRCC).      Objective:      To learn if SGI-110 causes GIST tumors to shrink or slows their growth. Also to test how it     acts in the body.      Eligibility:      People ages 12 and older who have GIST, PHEO/PGL, or HLRCC that has not responded to other     treatments      Design:      Participants will be screened with:        -  Physical exam        -  Urine tests        -  CT or MRI, or FDG-PET scan: A machine takes pictures of the body.        -  Blood tests      Participants will be injected with SGI-110 under the skin each day for 5 days. This cycle     will repeat every 28 days. The cycles repeat until their side effects get too bad or their     cancer gets worse.      Participants will have tests throughout study:        -  Physical exam and blood and urine tests before each cycle        -  Blood tests on days 1, 7, 14, and 28 of the first cycle.        -  Scans before cycle 1 and then every other cycle.        -  Questionnaires about their pain and quality of life        -  Tumor biopsy for those 18 and older: A needle removes a small piece of tumor.      After they stop treatment, participants will have a final visit. This includes an evaluation     of their health, pain, and quality of life.   "
9184|NCT03165708|"     The purpose of this study will be to evaluate the inter-rater agreement, or concordance,     between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for     the epidural space verification.      Primary study endpoint will be successful concordance of identification of ligamentum flavum     and epidural space during a standard epidural procedure in pregnant patient. Secondary     outcome will be successful concordance of identification of bony contact during a standard     epidural procedure in pregnant patient.   "
9185|NCT03165695|"     This study evaluates whether Ramelteon can prevent delirium, decrease the severity of     incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients.     Half of the patients will be assigned to Ramelteon, while other half will be assigned to     placebo.   "
9186|NCT03165682|"     Systemic lupus erythematosus is a chronic inflammatory autoimmune disease with an unknown     cause and many challenges. Whilst corticosteroids and effective immunosuppressive therapy     have transformed the management of patients with active systemic lupus erythematosus, one of     the major causes of morbidity in Systemic lupus erythematosus patients is chronic,     debilitating fatigue.      Despite frequent occurrence of fatigue in Systemic Lupus Erythematosus, to the best of our     knowledge, no studies have been directly performed to examine fatigue-related changes in     cortical motor function in Systemic lupus erythematosus. In this study, we hypothesized that     Systemic lupus erythematosus patients with fatigue and depression versus Systemic lupus     erythematosus patients without fatigue and depression would present an alteration of motor     cortex excitability.   "
9187|NCT03165669|"     This randomized controlled with cross-over trial aims to investigate the efficacy of a     cervical pillow (the Viscospring PostuRite made by SOFF-ART S.r.l. Via Maestri del Lavoro     49 - 05100 Terni, Italy) versus education in non-specific chronic neck pain. More     specifically, effectiveness will be measured using the following outcome measures: pain,     disability, sleep quality, cervical pillow satisfaction, and global perception of the     treatment effectiveness.   "
9188|NCT03165656|"     The purpose of the current study is to evaluate the progression of right ventricular function     and dimension in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by     performing a cross sectional case-control study.   "
9224|NCT03165188|"     This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA     requires for all participants in gene transfer protocols and assures that adequate follow-up     can be maintained for subjects who have received at least one dose of algenpantucel-L.   "
9281|NCT03164447|"     This study evaluates the efficacy, safety, and tolerability of UB-421 in conjunction with an     existing failing antiretroviral therapy (ART) for 2 weeks and optimized background therapy     (OBT) for 24 weeks, respectively.   "
9189|NCT03165643|"     Background Macrosomia at birth is associated with subsequent susceptibility to obesity,     abnormal glucose metabolism, hypertension and dyslipidaemia. Epigenetic reprogramming has     been reported to be involved in the development of human diseases caused by suboptimal     environmental or nutritional factors.      Objective The study was aiming to explore epigenetic mechanism influences on macrosomic     infants exposed to intrauterine hyperglycemia.      Design The investigators performed a genome-wide analysis of DNA methylation in cord blood     from macrosomic infants born to women with gestational diabetes or infants with normal birth     weight born to normal glucose-tolerant women in order to identify genes related to foetal     growth or early adipose tissue development. The candidate genes were then validated using     SEQUENOM MassARRAY after bisulfite conversion.   "
9190|NCT03165630|"     Background: Stroke is the leading cause of long-term disability in Singapore, and studies     have found that intensive specialized stroke rehabilitation can improve post-stroke     functional outcomes for a substantial proportion of stroke patients. However, despite the     benefits associated with adherence to prescribed rehabilitation, the uptake rate of     outpatient rehabilitation services (ORS) in Singapore is only 33%.      According to local longitudinal studies, the financial burden of out-of-pocket service costs     and the inconvenient transportation from home to rehabilitation centres are important     barriers to access to ORS.      Objective: To examine the effect and cost-effectiveness of providing incentives for ORS to     improve the uptake of ORS compared to usual care (control) with no incentives      Hypothesis: An evidence-based program to test the effectiveness of providing incentives to     alleviate the financial burden as well as inconvenience of transportation for ORS will     improve the uptake of and adherence to ORS among stroke patients.      Methodology: This study is an individual-based randomized controlled trial (RCT) of 300     stroke patients recruited from Singapore General Hospital (SGH) and Changi General Hospital     (CGH). They will be randomized to one of three study arms (education only, free     transportation, and free services and transportation) and interviewed at the time of     recruitment and four months after the enrolment in the study. Participants' health     conditions, socioeconomic situation, health & medical services utilization, stroke-related     disability measures, quality of life, and reasons for uptake/rejection/withdraw from the     services will be collected during both baseline and the 4th month assessments.      Significance: As the first study in Singapore to test innovative ways to increase the stroke     ORS uptake rates, it will provide evidence for future policy changes in financing outpatient     rehabilitation and other long-term care services in Singapore. It will also provide important     empirical parameter estimates for Systems Dynamics modelling of the demand and supply of ORS     in Singapore.   "
9191|NCT03165617|"     The randomized, observer-blind non-influenza comparator controlled study is intended to     demonstrate the efficacy, immunogenicity, safety and tolerability of Seqirus' cell-based     inactivated quadrivalent vaccine (QIVc) in subjects ≥2 years to <18 years of age   "
9192|NCT03165604|"     In the present study the investigators will examine the impact of varying information     (positive compared to standard information) concerning a drink for improving physical fitness     in overweight children.   "
9194|NCT03165578|"     The objective of the present study is to identify brain networks in patients that contribute     to successfully learning self-regulation with real-time fMRI.   "
9196|NCT03165552|"     Patients with abnormal kidney function are common in primary care, particularly in people     with other long standing illnesses. Some of these patients have long standing weakness of     their kidneys, others develop new kidney weakness alongside other new illnesses. Patients     with weak kidneys are more likely to be admitted to hospital, spend longer in hospital or die     than those with normal kidneys. Although these events are common, how kidney weakness     develops in the community is not well understood and awareness is poor. It is known that     appropriate attention to a patient's medical care at times of high risk may reduce the onset     of new kidney weakness. We have developed a new education package for primary healthcare     professionals and patients. This will teach them about risks of new kidney weakness in their     patients, give advice about how to combat them, and help prevent it occurring. This project     will also use a new software tool - IMPAKT EVOLVE-AKI - to extract information from primary     care systems and combine this with hospital data to identify developing kidney weakness much     more accurately primary care . Both these elements of the study have already been tested in     primary care and we are confident that they work well. Patients and the public have been     involved in the development of these tools and will also be closely involved in their     implementation. We now intend to implement the education more widely in primary care. We will     then test how effectively the education has been implemented and whether it has a significant     effect on the number of episodes of new kidney weakness developing in primary care. We     calculate that we will need to provide this education to 36 practices to be able to determine     accurately whether the programme significantly reduces new kidney weakness. Advice we have     received from colleagues in primary care indicates that they are very interested in this     education programme, and we believe that that a positive result from this study will lead to     rapid and wide implementation of this combined programme of education and data analysis to     the benefit of patients across the UK. This study fits well with a national programme of work     in this area, and this combination will help with wider adoption of the study findings when     the results are available.   "
9197|NCT03165539|"     This study will assess the incidence and risk factors for post-operative delirium in patients     undergoing thoracotomy. Specifically, the study will assess if there is any relationship     between an intra-operative decrease in brain oxygen levels which can occur during one-lung     ventilation, and the occurrence of delirium in the post-operative period.   "
9198|NCT03165526|"     FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD     Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a     post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD     Occluder.   "
9199|NCT03165513|"     The project aimed to create a dialogue between the informal sector (traditional and faith     healers) and the formal sector (trained health care workers) in order to increase synergy and     communication between the two systems, by minimizing any harmful practices and enhancing     complementary practices. The informal sector will also be trained on how to use WHO mhGAP-IG     component on depression for routine screening in order to ameliorate functional and social     outcomes and refer complicated cases to the formal sector for biological interventions   "
9200|NCT03165500|"     The surgery for the extraction of the third molars is a procedure in Dentistry that generates     a large picture of anxiety in the patient. One of the ways to try to soften this picture, are     the professionals to use sedation. Thus, the objective of this study was to evaluate three     sedation protocols, and to compare them with vital signs values, in order to obtain the     sedation method with greater patients stability.   "
9201|NCT03165487|"     The goal of the project is to identify a molecular signature of tumor stroma from normal     adjacent breast tissue obtained prospectively at the time of breast conserving surgery before     and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A     and triple negative breast cancer. IORT is considered as being standard of care. Our primary     aim is to determine if there are distinct protein signatures in the stroma of different     breast cancer sub-types.   "
9202|NCT03165474|"     The primary purpose of this study is to assess the feasibility and participant acceptability     of an interactive, internet/mobile-enabled dietary self management intervention. The     secondary purpose of this study is to determine if the intervention improves knowledge,     attitudes and food preferences associated with the targeted behaviors, to reduce childhood     obesity risk from baseline to post-test.   "
9282|NCT03164434|"     This observational study investigates ICP signals obtained through an external ventricular     drain in the brain connected with an external transducer. In particular, the study     investigates how drainage influences the monitored signal: influence of flow rate, reservoir     height and initial ICP before draining.   "
9203|NCT03165461|"     Failed intubation is currently one of the most important factors leading to morbidity and     mortality in anesthesia.      The development of supraglottic airway devices (SGDs), such as the intubating laryngeal tube,     has revolutionized airway management, as these devices allow adequate ventilation and     oxygenation in situations where ventilation and/or intubation via conventional means pose a     challenge. Several publications describe the usefulness of such devices for salvaging     ventilation in patients that cannot be intubated with direct laryngoscopy or who cannot be     ventilated with a facemask. In these salvage situations, SGDs are highly effective in     achieving adequate patient oxygenation.      Achieving effective oxygenation with an SGD and completely isolating the airway by intubation     at the same time. This is now possible thanks to the so called supraglottic intubation     devices (SGIDs). For that reason, we believe it is necessary to conduct a study that allows     evaluation of the performance of this device in the context of daily clinical practice.      Its design characteristics, its capacity to be used in intubation applications, its soft and     atraumatic materials as well as its disposability augur this product a significant expansion     in the next few years. Nonetheless, no data are available on the success of intubation when     the intubating laryngeal tube suction device (ILTSD) is used. The idea behind this study is     to assess the possibilities to use the ITLSD device to intubate patients in regular     anesthetic practice.   "
9204|NCT03165448|"     Patient's psycho-emotional status is being affected during various dental procedures causing     patient's and doctor's discomfort. There are three basic factors, composing psycho-emotional     status: fear, stress and pain sensitivity. There aren't any objective method that may help in     standard evaluation of oral surgery patient's psycho-emotional status. In the present     non-standardized evaluation, there is a problem of heterogeneity between studies, and also     ineffective patient's evaluation. Therefore, Universal Scale in oral surgery for patient's     psycho-emotional status rating (USOS) was designed. Clinical trial to validate the USOS was     constructed.   "
9205|NCT03165435|"     Study CV-0003 will be the second clinical trial administering CV-MG01 in humans. This will be     a phase 2/3 proof-of-efficacy therapeutic confirmatory study following the proof-of-concept     exploratory phase 1 study (CV-0002).   "
9206|NCT03165422|"     This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma     in Japan   "
9207|NCT03165409|"     This study is a real-world retrospective claims analysis to assess and compare AE-related     HCRU and medical costs among patients with different follow-up frequency after initiating a     melanoma therapy.   "
9663|NCT03159455|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising     doses The Caucasian group will receive higher dose only.      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI     1467335 in healthy Japanese and Caucasian male subjects.   "
9208|NCT03165396|"     According to the inclusion and exclusion criteria, elderly patients undergoing elective     orthopedic surgery were randomly divided into four groups. The different combinations of     propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients     become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive     function was evaluated using a professional cognitive scale and other indicators. Finally,     statistical analysis.   "
9209|NCT03165383|"     Effective postoperative pain control results in decreased cardiac and pulmonary     complications, patient satisfaction and early mobilization. A prospective, randomized     comparative study was done of analgesic efficacy, opioid requirement and side effects in     patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided     Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given.     Patient controlled analgesia (PCA) with intravenous morphine was given to both group     patients, and total good PCA demands in both the groups was studied.   "
9210|NCT03165370|"     Insomnia is one of the most main diseases of civilization in the world, which chronic     insomnia is up to 30% in Taiwan under the latest statistics and a common disease which     appears to sleep difficultly, sleep interrupted, wake up early or wake up still tired.     Long-term persistence of these symptoms will lead to the occurrence of mental illness and     then affect people's emotional behavior and cognitive memory, showing that insomnia is an     important modern health issues. Recently, individual response patterns was proposed by     modern medicine. This thinking process and spirit seems to be compatible with the traditional     Chinese medicine (TCM) therapy of Differential Treatment. The purpose of this study, the     Athens Insomnia Scale (AIS), commonly used to quickly screen for insomnia patients and the     evaluation of Western medicine efficacy in Western medicine clinic, and investigation of     Syndrome Type of TCM to find out whether with Syndrome Type of TCM and AIS in the associated     factors, and confirm the necessity and importance of Syndrome Type of TCM, for future     reference and basis for the development of integrated medicine.      In the cross-section study with an interview on survey, sampling Miaoli County an Chinese     medicine clinic, in line with standard sampling of 200 patients with insomnia were recruited.     The questionnaires contained two instruments including Athens Insomnia Scale (AIS), and     Syndrome Type of TCM questionnaire. Cross-table, chi-square test, variance analysis and     Pearson product-moment correlation was used to find the relation.   "
9211|NCT03165357|"     The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and     placebo (PLA) supplementation on body composition, physical capacity, as well as     concentrations of the selected biochemical blood markers in trained athletes, in a     randomised, double-blind, placebo-controlled crossover trial.   "
9238|NCT03165006|"     This is a multicenter retrospective cohort of women participating in breast cancer screening     programs in Spain between 2000 and 2009, with a cancer diagnosed during the screening or     between the screening interval (interval cancer), specifically true interval cancers and     false negatives. The investigators obtained woman-related information (including breast     density), tumor-related information (including tumor phenotype), and follow-up information     (including relapses, second neoplasms and vital status at the end of follow up (June 2014)).     The objective is to evaluate the survival and disease-free period of women participating in     screening programs for breast cancer with a cancer diagnosed during the screening or an     interval cancer, specifically true interval cancers and false negatives.      This study is part of a broader project (CAMISS study), which also includes one prospective     cohort (CAMISS Prospective cohort - Identifier in ClinicalTrials.gov: NCT02439554).   "
9212|NCT03165344|"     Endoscopic submucosal dissection as the fastest growing endoscopic treatment technology in     the past decade has been widely used in the treatment of early esophageal cancer and gastric     cancer without local lymph node metastasis. The main complications of ESD treatment of early     esophageal cancer are hemorrhage, perforation, postoperative esophageal stenosis, infection,     etc. Postoperative esophageal stenosis is the most common and major complication after ESD     treating patients with lesion involving more than 2/3 esophagus cycle. It is very important     to prevent esophageal stricture after ESD. Glucocorticoid is gradually concerned by clinical     research because it can inhibit local inflammatory response and reduce the formation of     connective tissue in order to prevent postoperative stenosis. The specific usages include     endoscopic injection of corticosteroids, oral corticosteroids and combination of them. The     study shows that the incidence of esophageal stricture after using glucocorticoid can be     reduced effectively. Currently, there is no uniform consensus on the use of glucocorticoids,     such as specific drugs, dosage, course of treatment, route of administration. In particular,     efficacy comparison of different routes of administration is laking. Studies have shown that     endoscopic injection triamcinolone acetonide in some patients with intractable esophageal     stricture is not very effective, but it can be treated with oral corticosteroids. Aluminium     Phosphate Gel is a kind of neutral buffer. The main component aluminum phosphate can form a     strong ion buffer system in acidic environment. The structure of its auxiliary components     agar and pectin is similar to that of natural mucus. It forms a mucous layer in the esophagus     to restore and protect the esophageal mucosa. Therefore, investigators assume the     hydrocortisone sodium succinate aluminum phosphate mixed gel can be used for preventing     postoperative ESD stenosis of patients with a large area of early esophageal cancer. This     study will design a randomized controlled trial to compare the effect of oral hydrocortisone     sodium succinate mixed Aluminium Phosphate Gel and local injection of triamcinolone acetonide     plus oral prednisone for the prevention of ESD postoperative esophageal stricture in patients     with a large area of early esophageal cancer.   "
9213|NCT03165331|"     A visible difference can have a profound impact in a society with a massive emphasis on     appearance and looks. A vulnerable group is adolescents with a condition affecting their     appearance as a result of injuries (burns, accidents), treatment (cancer), skin conditions or     congenital anomalies (birthmarks, craniofacial conditions). Research has identified potential     psychological difficulties, which, if not addressed, can lead to anxiety, depression, and     eating disorders.      In addition to medical treatment options, aiming at diminishing a difference that may be     visible to others, young people with appearance concerns also need self-management skills.     However, evidence-based interventions are scarce and specialised psychological treatment is     difficult to reach.      The Centre for Appearance Research (Bristol, UK) has developed an online intervention for     adolescents, now translated into Norwegian (www.ungfaceit.no). UNG Face IT provides easy     access to specialist advice and support via a home computer, using information, videos, and     interactive activities. It provides advice, teaches coping and social skills, strengthening     psychological adjustment to a visible difference.      A systematic evaluation of the Norwegian version is needed. UNG Face IT could potentially     address unmet needs, provide a cost-effective tool to reduce the need for face-to-face     psychological and surgical/medical services, and contribute to make online health care     available for young people with a visible difference.   "
9214|NCT03165318|"     This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass     postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction     surgery. Half of the participants will receive the PEMF therapy in combination with standard     rehabilitation programme, while the other half will receive sham therapy in combination with     standard rehabilitation programme.   "
9215|NCT03165305|"     Sustained inflation (SI) has been reported to be effective for reducing the need for     intubation and/or invasive ventilation in preterm infants. However, it has also an important     role to support the initial breaths and liquid removal from the airways. Therefore, we     hypothesized that SI performed just after birth may help to facilitate the transitional     period and decrease the incidence of early respiratory morbidities such as transient     tachypnea in term infants.   "
9379|NCT03163173|"     GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer     patients who receive radiation and chemotherapy.      In this study, GC4419 will be mixed with a small amount of radioactive material in order to     find out how much study drug is in the blood and to see how the drug is processed and     eliminated from the body. The safety and how subjects tolerate the study drug will also be     studied.   "
9217|NCT03165279|"     To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal     Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use.     To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic     aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith     AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who     experience successful treatment at 1 year post-implant; defined by technical success and     clinical success.   "
9218|NCT03165266|"     Right ventricular infarction usually occurs in association with inferior myocardial     infarction in about 10-50% of the cases. Currently the presence of elevation in right     pericordial leads is the most powerful indicator of right ventricular infarction.      The incidence of right ventricular infarction is more in postmortem studies,meaning that     Right ventricular infarction is underestimated, possible explanation for this difference     could be explained that electrocardiographic sign of Right ventricular infarction disappear     early or patients presented late.   "
9219|NCT03165253|"     The aim of the study is to evaluate the effects of the synbiotic Bifidobacterium animalis     ssp. lactis B94 plus inulin addition to the standard triple therapy on Helicobacter pylori     infection eradication rates in children.   "
9220|NCT03165240|"     The primary objective of this current trial is to investigate the safety and tolerability of     5 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy     as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor     blockers [ARB].      Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine     Ratio [UACR].   "
9221|NCT03165227|"     The main objective of this trial is the safety and tolerability of 4 multiple rising oral     doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as     adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker     (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important     diagnostic marker of nephropathy.   "
9222|NCT03165214|"     Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related     to the pelvis of either men or women for more than 6 months according to The International     Association for the Study of Pain. In other words, chronic pelvic pain with associated     ovarian vein varicosities is termed pelvic congestion syndrome and is an important but     under-diagnosed condition   "
9283|NCT03164421|"     N-Acetylcysteine and L-carnitine were used in pcos patients   "
9225|NCT03165175|"     The aims of this pilot study are: (1) to assess the feasibility and acceptability of a mobile     application to educate military members about the risks of prescription drug misuse; (2) to     determine if there is evidence that the mobile application plus treatment as usual reduces     the risk of prescription drug misuse and shows differences in related measures compared to     treatment as usual among military medical clinic patients currently taking prescription     medication; and (3) if evidence of reduced risk is found, to estimate effect sizes for a     future effectiveness trial. The pilot study will use a randomized controlled design with two     groups. The control group will be provided with treatment as usual (TAU), and the     experimental group will be provided with the MedAware smartphone application in addition to     treatment as usual (app + TAU). Self-reported measures of risk of misuse and related     attitudes and knowledge will be administered to all participants at baseline, 1 month, and 3     months. The mobile app is a brief intervention designed to help military members to assess     their risk for medication misuse and provide individualized feedback on risk level with     recommendations for reducing risk. The app also contains other features, including sections     in which to store information on current medications and look up drug interactions and     provides resources for help.   "
9226|NCT03165162|"     The purpose of this project is to gain a better understanding of the underlying consumer     motivations associated with choosing foods labeled as natural; and further, how the use of     this term impacts the amount of food consumed.   "
9227|NCT03165149|"     The aim of this study is to investigate the effect of addition of different doses of Ketamine     locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the     probability of developing chronic post-mastectomy pain.   "
9228|NCT03165136|"     Recurrent miscarriage (RM) defined by >=3 consecutive losses affects 1% of fertile couples.     Most women have recurrent early loss with a failure of development before 10 weeks'     gestation. Standard investigations fail to reveal any apparent cause in >50% of couples.      No study has demonstrated any benefit of any medication in women with Unexplained RM, in the     presence or absence of an inherited thrombophilia.      Moreover, the benefit of aspirin and/or heparin has not been proved in women with     Antiphospholipide (APL) antibody without other clinical manifestations of Antiphospholipide     Syndrome.      Hydroxychloroquine (HQ) is a molecule whose properties (anti-thrombotic, vascular-protective,     immunomodulatory, improved glucose tolerance, lipid-lowering, anti-infectious) could be     usefull against mechanisms of Unexplained RM.      There is no data concerning the benefit of HQ in RM in the presence or absence of     antiphospholipid antibodies or any inherited thrombophilia.      Administration in (Systemic Lupus erythematosus (SLE) women and for Malaria prevention     provides extensive safety data during pregnancy.      Oral administration makes possible treatment since the preconception period. For all of that     and its low cost, hydroxychloroquine should be evaluated in RM whatever the woman     thrombophilic status.   "
11021|NCT03141632|"     The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but     also thirst perception. It is hypothesized that GLP-1 analogues reduce fluid intake in     healthy volunteers compared to Placebo.   "
9229|NCT03165123|"     Postoperative nausea and vomiting is defined as any nausea, retching, or vomiting occurring     during the first 24-48 h after surgery in inpatients. Postoperative nausea and vomiting is     one of the most common causes of patient dissatisfaction after anesthesia, with reported     incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In     addition, postoperative nausea and vomiting is regularly rated in preoperative surveys, as     the anesthesia outcome the patient would most like to avoid. While suture dehiscence,     aspiration of gastric contents, esophageal rupture, and other serious complications     associated with postoperative nausea and vomiting are rare, nausea and vomiting is still an     unpleasant and all-too-common postoperative morbidity that can delay patient discharge from     the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.   "
9230|NCT03165110|"     The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used     with the Contour Next One meter (the Onyx system).   "
9231|NCT03165097|"     The primary purpose of this study is to evaluate the safety and tolerability of ascending     multiple doses of ACT-709478 in healthy male and female subjects   "
9232|NCT03165084|"     The aim of this study is to develop and evaluate a person-centred digital intervention in     primary healthcare for people with T2D, in addition to their usual diabetes care.   "
9233|NCT03165071|"     The primary purpose of this study is to investigate the fate of ACT-132577 in healthy     subjects and in people with severe kidney disease   "
9234|NCT03165058|"     In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive     technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity     changes in the colonic epithelium.   "
9235|NCT03165045|"     The objective of this NIS is to measure changes in health status including functional status     using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to     label after approximately 6 weeks in routine clinical practice.   "
9236|NCT03165032|"     The purpose of the current study is to evaluate the right ventricular function during graded     cycling on an ergometer by transthoracic echocardiography in Kyrgyz highlanders with high     altitude pulmonary hypertension (HAPH) by performing a cross-sectional case-control study.   "
9237|NCT03165019|"     The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz     highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal     cohort study. To this end, the investigators will invite the same highlanders who     participated in the study in 2012 to undergo follow-up examinations in 2017, in order to     allow comparisons of current results with baseline data from 2012.   "
9239|NCT03164993|"     This is a randomized, double-blind, placebo-controlled phase II study evaluating the safety     and efficacy of Atezolizumab when combined with immunogenic chemotherapy in subjects with     metastatic triple-negative breast cancer. Atezolizumab, pegylated liposomal doxorubicin and     cyclophosphamide are the Investigational Medicinal Products (IMPs).   "
9240|NCT03164980|"     This is a multicenter, randomized, controlled, open-label study including patients with     recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer.      The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD     with other standard platinum-based chemotherapy in platinum-sensitive disease.   "
9242|NCT03164954|"     Following surgery, some but not all patients develop persistent (or chronic) postoperative     pain CPSP. Several risk factors for this persistent pain have been confirmed in previous     studies, but neither surgeons nor anesthesiologists have or take the time to systematically     screen patients for this risk. However, hospital information systems often contain the data     already, entered during preoperative consultations (e.g. chronic opioid medication) or     obtained during the postoperative period (e.g. pain scores).      Here the investigators test an automatic detection algorithm which alerts the analgesia team     when a patient at risk of CPSP is or has been operated.   "
9243|NCT03164941|"     Selective Laser Trabeculoplasty (SLT) is a glaucoma treatment that has been shown to     effectively lower intraocular pressure by increasing aqueous outflow through macrophage     recruitment. There is evidence of increased drainage in the nasal quadrants of the eye. This     study aims to compare whether there is a difference in the reduction of eye pressure when SLT     is performed nasally and temporally.   "
9244|NCT03164928|"     To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as     assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of     age with Glucocorticoid (GC)-induced osteoporosis (GiOP).   "
9245|NCT03164915|"     The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in     adult subjects with ITP. The primary objective of this study is to determine the responder     rate. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase     of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without     bleeding. The secondary objectives are to evaluate the further efficacy assessments including     duration of response, and the safety of LIV-GAMMA SN Inj.   "
16625|NCT03067883|"     To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin     based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis     patients.   "
9246|NCT03164902|"     This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence     and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their     hepatitis therapy. In this single-arm, prospective study, subjects at high risk for     nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with     ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the     providers will have access to the ingestion adherence.   "
9247|NCT03164889|"     Previous studies indicated that Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)     could improve survival rate in patients with acute liver failure and obtain higher HBsAg     seroconversion rate when in combination with peg-interferon for chronic hepatitis B (CHB)     patients. In this study, investigators will study the clinical effect of entecavir (ETV) plus     GM-CSF in patients with CHB compared to ETV monotherapy.   "
9248|NCT03164876|"     This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after     repeated doses in patients with stable but symptomatic schizophrenia, taking one or two     established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition     and tests of auditory function and electrophysiological measures in addition to routine     safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a     key objective is to characterize this range of biomarkers which will inform the future     development of the drug.   "
9249|NCT03164863|"     Millions of cancer patients every year receive chemotherapy with only a 20-60% probability of     pathological response, while most experience adverse side effects that lower quality of life     without prolonging it. Reliable identification of ineffective therapies can eliminate     needless human suffering while increasing overall probability of positive response to     treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits     strong resistance to a therapy prior to its final selection by the oncologist. However, there     are no effective methods for quickly assessing patient chemotherapy resistance. Patient     Derived Xenograft (PDX) models have replaced older Chemotherapy Sensitivity and Resistance     Assays (CSRAs) to some degree, but both technologies suffer from long testing times, high     cost, and/or low accuracy.      Motility Contrast Tomography (MCT) has recently emerged as a technology that measures the     biodynamic response of intact tumor biopsies to applied therapeutics by using Doppler     detection of infrared light scattered from intracellular motions inside living tissue.     Several small scale animal, xenograft, and human studies have shown this phenotypic profiling     technique to be highly accurate in prediction of response and resistance to chemotherapy.     This project will be the first human trial of biodynamic phenotyping to predict chemotherapy     response among breast cancer patients. Specifically, the study cohort will include patients     selected for neoadjuvant chemotherapy treatment, because this setting offers the opportunity     for near-term outcome measurement at the time of post-chemo surgery. Pre-therapy fresh tumor     specimens will be imaged using MCT, and the resulting bio-dynamic signatures will be compared     to confirmed pathological response at the time of surgery. Observation of a high predictive     value will provide the basis for expanded clinical trials and prompt commercialization of a     biodynamic chemotherapy selection assay for breast and other cancer patients.   "
9250|NCT03164850|"     During laparoscopic surgery, video camera becomes a surgeon's eyes since the surgeon uses     image from the video camera positioned inside the patient's body to perform the procedure.     The greatest limitation is the impairment or complete lack of tactile sensation normally used     to assist in surgical dissection and decision making. The Investigator proposes to develop a     tactile sensing system, Laparoscopic Tactile Imager (LTI), to be used in urogynecological     laparoscopic surgery for tactile imaging and tissue characterization (elasticity, structure,     boundaries, blood vessel detection) which will be imposed on the video image at area of     interest in real time.   "
9251|NCT03164837|"     This is an open-label positron emission tomography/computed tomography (PET/CT) study to     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in prostate     cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-RM26 will be     injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT     images.   "
9252|NCT03164824|"     The purposes of this study were to conduct cross-cultural adaptation of the Functional Rating     Index (FRI), to test psychometric properties of the translated questionnaire and to examine     head-to-head comparisons with other questionnaires.   "
9253|NCT03164811|"     The investigators will do the Goal directed fluid therapy by protocolized fluid management in     the experimental group, using PPV to guide the fluid administration, compare with standard     fluid management in patients undergoing complex spine surgery.   "
9284|NCT03164408|"     The necessity of orthopedic implant removal is under intense discussion and even if it is     performed as an elective procedure, the risk of complications is present.      Aim of the study is to identify parameters responsible for an increased risk of early     post-operative complications after elective aseptic orthopedic implant removal.   "
9254|NCT03164798|"     This study aims to develop the quantitative biomarker to establish the individualized     strategy in stroke rehabilitation. Brain-derived neurotrophic factor (BDNF) acts on certain     neurons of the central nervous system (CNS) helping to support the survival of existing     neurons, and encourage the growth and differentiation of new neurons and synapses. BDNF in     CNS can be assessed by analysing serum BDNF. The final objective of this study is to     demonstrate a role of biomarker of BDNF in stroke rehabilitation to establish the     individualized strategy.   "
9255|NCT03164785|"     The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao     Capsule on diabetic kidney disease in T2DM patients.   "
9256|NCT03164772|"     This is an open-label multicenter 2-arm study to evaluate the safety and preliminary efficacy     of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC.      Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 [durvalumab] Arm B: mRNA     Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 [tremelimumab]      For each arm of the study, there is a dose escalation phase in which the Recommended     Combination Dose (RCD) is determined according to a standard 3 + 3 design. The dose     escalation phase is followed by an expansion phase, in which the cohort at the RCD is     expanded to 20 subjects (inclusive of the subjects from the dose escalation cohort).   "
9257|NCT03164759|"     Correlate the implant stability quotient values measured by ostell device with radiographic     bone density measured on CBCT by bluesky software pre-operatively   "
9258|NCT03164746|"     Severe injurious behaviors in children with autism spectrum disorder are challenging. First     line treatment approaches include behavioral techniques but pharmacotherapy is frequently     required despite frequent adverse effects in youths.      Therapeutic body wraps has been reported in small series or case reports, but has never been     assessed in the context of a randomized controlled trial.      The present study is an exploratory, multicenter, randomized, controlled, open label with     blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic     body wraps in children presenting with autism spectrum disorder and severe injurious     behavior.   "
9708|NCT03158870|"     Collaboration between the surgeon and the anesthesiologist is key for delivering a safe     pheochromocytoma surgery. This study aims to establish the collective performance of     surgeon-anesthesiologist team by quantifying the relationship between their previous     collaborations and patient complications.   "
9259|NCT03164733|"     Wear is the main reason for revision operations after joint arthroplasty. While the survival     of modern implants is often longer than the expected life span in old patients, young     patients (<60 years) have to expect at least one wear induced revision operation. The reason     is the throughout all registries consistantly significantly reduced implant survival rates in     young patients. In the swedish arthrplasty registry the 15 year survival for patients older     than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a     5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant     difference cannot be explained by the higher activity of younger patients alone. Patient     specific factors, that modulate the biological reaction on wear particles, are therefore     highly probable. These could explain the significant age dependency of implant survival.      The main hypothesis of this study is therefore, that the biological reaction on wear     particles depends on the patients age.   "
9260|NCT03164720|"     Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting     many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild     manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life     threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN     is one of the most serious SLE complications since it is the major predictor of poor     prognosis .      Lupus nephritis is a common major organ manifestation and main cause of morbidity and     mortality of the disease . It is occurred in 30-50% of SLE patients at initial diagnosis and     more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients     will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year     survival rate of a patient with severe LN is less than70-80%. Therefore, an involvement of     renal disease activity is one of the most important prognostic factors for patients with SLE,     and the diagnosis of SLE patients with LN has an important clinical implication in guiding     the treatment of SLE in clinical settings.   "
9261|NCT03164707|"     Coronary atherosclerosis is the leading cause of death worldwide. Diabetes mellitus is     associated with increased prevalence of coronary artery disease      Increased plasma glucose is a common feature in the acute phase of myocardial infarction,     even in patients without diabetes. Patients with stress hyperglycemia, but without previous     diagnosis of diabetes, were at increased risk of congestive heart failure, arrhythmia and     cardiogenic shock as well as increased both in-hospital and long-term mortality . Previous     studies have demonstrated larger infarct size and poorer prognosis inpatients with     hyperglycemia upon hospital admission compared with patients without hyperglycemia      It has been reported that stress hyperglycemia impairs microvascular circulation and may lead     to no-reflow phenomenon. No reflow phenomenon was significantly more frequent among patients     with hyperglycemia and increased progressively with increasing admission blood glucose in     patients with Acute Myocardial Infarction . Furthermore, patients with high admission glucose     are more likely to develop restenosis and require repeat revascularization procedures     compared with those with normal admission glucose and are also at increased risk for repeated     Myocardial Infarction, stent thrombosis and death.   "
9262|NCT03164694|"     The purpose of this study is to studying the addition of apatinib with chemotherapy to     investigate the efficacy and safety of apatinib in combination with chemotherapy in patients     with advanced NSCLC.   "
9263|NCT03164681|"     Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl     increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular     administration of a contrast agent.   "
9264|NCT03164668|"     The purpose of this formative study is to provide preliminary data regarding how the     availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of     a ban on menthol flavored cigarettes   "
9285|NCT03164395|"     This study seeks to determine the efficacy of single coil defibrillation leads for     cardioversion of persistent atrial fibrillation.   "
9266|NCT03164642|"     This project will determine whether an intervention to enhance communication between infants     and toddlers with developmental disabilities and their depressed mothers can be integrated     into federally-funded Early Intervention (EI) services. Participants will be mothers with     depressive symptoms whose children are receiving EI services, along with their EI service     providers.      The investigators will conduct a small randomized control trial using the Language     ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring     system, with 20 mothers and one of their child's EI service providers. The LENA uses an     infant or toddler garment with an integrated audiotape system that records adult speech     centered on the child, child vocalizations, and reciprocal parent-child turn-taking     conversations. The LENA software produces visual feedback that a mother can use to focus her     language interactions with her child. A LENA with feedback group will follow participants     in the intervention over 5 weeks: 5 weeks of LENA data collection (with mothers running the     system 1 day/week for 16 consecutive hours), with feedback during 3 weeks (baseline=LENA, no     feedback; 3 week intervention=LENA with feedback; post-intervention=LENA, no feedback). A     LENA no feedback group will complete LENA data collection at baseline on the same schedule     but will not receive feedback. The main difference between groups will be provision of LENA     feedback and strategies to promote increased mother-child interactions. This design allows     the investigators to isolate the effect of LENA with feedback, and minimizes attributing     changes in language environments due to exposure to LENA alone. The investigators will     analyze data from measures on LENA communication data (adult word count, child vocalizations     and conversational turn-taking), and measures of child language, maternal depressive     symptoms, and child disability profiles.   "
9267|NCT03164629|"     The purpose of this research study is to learn about how cone-beam Computerized Tomography     scans (X-ray images taken from different angles) work together with an embolization guidance     software (helps the doctor see the arteries that feed the prostate)to find and see arteries     in the prostate.   "
9268|NCT03164616|"     This is a randomized, open-label, multi-center, global, Phase III study to determine the     efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC)     chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as     first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with     tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic     lymphoma kinase (ALK) fusions.   "
9269|NCT03164603|"     This is an open-label Phase I study to evaluate the safety, tolerability, and     pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to     inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system     attack solid tumor cells more effectively.   "
9270|NCT03164590|"     This study aims to compare the effects of local wound infiltration with ketamine versus     dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total     abdominal hysterectomy.   "
9271|NCT03164577|"     This study is focused on conducting a stage 1b feasibility pilot trial among 60 AI/AN men and     women (for a final sample of 48 at follow-up) in an urban outpatient treatment setting to     analyze the potential benefits of Drum-Assisted Recovery Therapy for Native Americans     (DARTNA). Dr. Dickerson, Principal Investigator, is collaborating with Dr. Elizabeth D'Amico,     co-Investigator, with Sacred Path Indigenous Wellness Center, a community-based organization     providing consultative services for American Indians/Alaska Natives (AI/ANs).      A feasibility randomized clinical trial will be conducted within an urban setting and will     compare urban AI/AN males and females with AOD disorders who receive DARTNA (n=30) to AI/AN     males and females with AOD disorders who receive usual care plus (n=30). Compare outcomes at     end of treatment and 3-months post-treatment to gather data that can be used to judge the     feasibility of a larger trial, and to plan that trial. Obtain information on (a) clinically     significant changes in AOD use, (b) clinically significant changes in mental health, physical     health, spirituality, cognition, adoption of 12-step principles and practices, and cultural     identification, and (c) estimate covariate correlations, reliability of measures and likely     effect sizes.   "
9272|NCT03164564|"     This study will evaluate the safety and efficacy of the long-acting injectable agent     cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine     (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.   "
9273|NCT03164551|"     The main purpose of the study is to evaluate the overall clinical value of GERI+ as an     integrated embryo culture and assessment system, providing an undisturbed culture     environment, continuous monitoring of embryo development and automated scoring using a     predictive algorithm.   "
9274|NCT03164538|"     The focus of this study is to examine the feasibility, acceptability, and impact of a     customized, combined positive psychology and motivational interviewing (PP-MI) health     behavior intervention versus a diabetes education intervention in a group of patients with     type 2 diabetes (T2D).   "
9275|NCT03164525|"     The prospective study set forth to test Thai version CPOT and BPS for validity, reliability,     and practicality. After translation, both pain scales were tested for concurrent validity,     discriminant validity, criterion validity, and inter-rater reliability in patients who were     intubated during the postoperative period. Opinions regarding practicality were elicited via     questionnaires from nurses who had been using and were familiar with these two pain scales.   "
9276|NCT03164512|"     This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol     administered via inhalation and oral ingestion.   "
9277|NCT03164499|"     This is a randomized controlled trial aimed to design an intensive intervention to modify     lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness.     200 participants aged 35-74 years who have intermediate cardiovascular risk will be included.     Subjects will be selected by consecutive sampling at urban primary care health centers from     Salamanca (Spain) and they will be randomized to a control or an intervention group. Both     groups will receive individual standardized counselling on healthy diet, daily physical     activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals     from the intervention group will receive additional group counselling and follow-up calls.     The effect of the intervention will be assessed using lifestyles and quality of life     questionnaires, metabolic control parameters, inflammation markers, anthropometric and     vascular function measurements, and neuropsychological tests.   "
9278|NCT03164486|"     This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well     it works in imaging patients with primary or cancer that has spread to the breast,     colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may     improve the ability to locate cancer in the body.   "
9279|NCT03164473|"     The purpose of this study is to investigate, after achievement of remission, the efficacy of     rituximab compared with azathioprine maintenance therapy on duration of remission, in     patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA     receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.   "
9286|NCT03164382|"     This trial was designed to investigate whether the survival outcome, response rate and safety     of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients     with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than     those of the standard treatment with sorafenib or not.   "
9287|NCT03164369|"     The aim of this double blinded study is to assess the abilities of the SpineNav3DTM     technology (Accuro) to identify the lumbar epidural space in parturients using as comparator     a standar ultrasound (US) device.   "
9315|NCT03164005|"     The investigators will enroll about 120 subjects from the hospital's healthcare center. The     investigators will collect the basic informations, blood pressure, body mass index, fasting     blood glucose and fasting blood lipids of each subject. The investigators will collect the     blood samples and then test them for fasting insulin levels, VEGF-B levels, the gene promoter     region methylation status and the genomic protein methylation levels of the VEGF-B gene of     the cells，and finally do the statistical analysis.   "
9288|NCT03164356|"     The purpose of the proposed study is to conduct research on individuals with lower limb     amputation, evaluating if residual limb fluid volume data collected using a novel     non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as     determined by amputee test subjects and practitioners (prosthetists). Participants' residual     limb fluid volume will be monitored through bioimpedance analysis both before and after a     practitioner-issued modification to the prosthesis as an observational cohort study and then     as a blinded randomized control trial in which the data may or may not be shared with the     practitioner before the modification is made to the prosthesis.   "
9289|NCT03164343|"     The primary objective of this study is to examine whether Pain Neuroscience Education for     children is able to increase a child's knowledge on the neurophysiology of pain.      In addition, this study investigates the influence of PNE on several pain related outcomes;     pain-related fear, pain catastrophizing and pain vigilance and awareness.   "
9290|NCT03164330|"     Workplace wellness programs have become a $6 billion industry and are widely touted as a way     to improve employee well-being, reduce health care costs by promoting prevention, and     increase workplace productivity. Yet, there is little rigorous evidence available to support     these claims, partly because the voluntary nature of these programs means that participants     may differ from nonparticipants for reasons unrelated to the causal effects of the wellness     program. The investigators will implement a randomized control trial to identify the effects     of incentives on wellness program participation, produce causal estimates of the effect of     wellness programs on health outcomes, determine what kinds of employees benefit from wellness     programs the most, and test for the presence of peer effects in wellness participation.   "
9291|NCT03164317|"     This study evaluates the effect of a mobile health technology enabled trained nurse led     intervention on control of blood pressure among patients with hypertension seeking care in     the community health centres in the southern state of Andhra Pradesh, India. half the     community health centres will receive the intervention and the other half will receive the     routine care.   "
9292|NCT03164304|"     Preeclampsia is commonly viewed as one of the hypertensive pregnancy disorders, which cover a     spectrum of clinical presentations from chronic hypertension ( hypertension occurring prior     to 20 weeks of gestation) and gestational hypertension (hypertension occurring after 20 weeks     of gestation) To more severe forms, including preeclampsia, eclampsia (its convulsive form),     and HELLP syndrome (hemolysis, elevated liver enzyme S, and low platelets)   "
9293|NCT03164291|"     Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections     who have failed or are intolerant of rifampin.      Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or     intolerant of rifampin.   "
9294|NCT03164278|"     The objective of this research study is to assess the effectiveness of an independent     transfer training program (ITTP), and to determine methods which may increase overall success     of an online training program.   "
9295|NCT03164265|"     Phase I/II, single center, prospective, open-label, non-controlled, non-randomized,     interventional, cohort study in which low risk living donor liver transplant (LDLT)     recipients will receive a single infusion of donor-derived DCreg 1 week prior to     transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6     months after transplantation. At that time point, recipients meeting specific criteria will     be slowly weaned off MPA per standard of care over a period of 6 months. Participants will     then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet specific     criteria be weaned off Tac over 6 months . Successfully weaned participants who remain     rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression.   "
9296|NCT03164252|"     The low-power laser provides the body with an improvement in the inflammatory response. Thus,     the objective of this study is to evaluate two laser application protocols in 60 patients     requiring surgical treatment for extraction of third molars included, without distinction of     race or gender, aged between 16 and 40 years, coming from the Faculty of Dentistry Of São     José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 -     intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) , group 2 -     intraoral irradiation with 660 nm laser at a dose of 30 J (30 mW, 30 J / cm 2) and group 3-     control group, with application of placebo laser. At 3 and 7 days after surgery, the patients     will be evaluated by two evaluators who will measure edema, trismus and pain. The tissue     repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic     analysis and periodontal conditions in the distal of the lower second molar. The results will     be submitted to descriptive statistics and compared using the statistical analysis of     variance (ANOVA) and Tukey test with significance level of 5%.   "
9305|NCT03164135|"     The investigators performed this study to evaluate the safety and feasibility of     transplantation with CRISPR/Cas9 CCR5 gene modified CD34+ hematopoietic stem/progenitor cells     for patients that develop AIDS and hematological malignances. Patients will be treated with     antiviral therapy (ART) to achieve undetectable HIV-1 virus in peripheral blood before     conditioning. CD34+ cells from donors will be infused into the patients after treatment with     CRISPR/Cas9 to ablate CCR5 gene.   "
11671|NCT03133143|"     The investigators aim to establish a research project to test the impact of gaming by     carrying out a video gaming interventions, monitoring its cognitive and clinical outcomes,     while concurrently performing a multimodal brain imaging experiment.   "
9297|NCT03164239|"     The purpose of this regional parallel-group RCT was to assess the effect of a six-month     tailored telephone and email based physical activity intervention on various measures of     physical fitness and body composition in a sample of physically inactive adults. A total of     111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either     an intervention group (IG;n=56) or a no-intervention control group (CG;n=55). The IG received     tailored exercise recommendations, every two months by email or mail (print) in addition to     motivational follow-ups every second week, alternatively by email and telephone. Primary     outcome measures were various objective measures of musculoskeletal and cardiorespiratory     fitness in addition to various measures of body composition, including waist circumference,     body mass index and fat percentage, which were assessed pre- and post-intervention.   "
9298|NCT03164226|"     The objective of this study is to verify the contribution of digital plethysmography in the     early diagnosis of acute coronary syndrome in emergency departments.      To determine the sensitivity, specificity, negative and positive predictive value of this     method that was not previously used for this purpose.   "
9299|NCT03164213|"     The purpose of this study is to investigate effects of tDCS stimulation in the left primary     motor area followed by naming therapy to improve language functions in patients with aphasia     in the sub-acute stage.   "
9350|NCT03163550|"     This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group     study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug     interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in     healthy subjects and otherwise healthy subjects with moderate or severe renal impairment.   "
9300|NCT03164200|"     Aging is associated with an increased risk for metabolic diseases, such as type 2 diabetes     and cardiovascular disease. There is reason to believe that the time of day when specific     food groups are eaten affects this risk. The investigators propose that eating foods made up     of fat and protein (such as eggs) in the morning for breakfast, rather than foods made up of     carbohydrates (such as white-bread toast or sugary cereal) may promote a healthier     metabolism. This is because the body is designed to burn fat during times of fasting, such as     overnight, during sleep. Thus, the body is not prepared to burn sugar early in the morning,     when most people eat breakfast. Studies with mice have shown that a sugary breakfast meal     inhibits the ability of the body to burn fat for the entire day. In contrast, a breakfast     meal with more fat enabled the animals to burn fat as well as other fuels throughout the day.     The ability to burn fat is thought to minimize risk for obesity, as well as related diseases     such as type 2 diabetes and heart disease. The purpose of this study is to determine if, in     older adult humans, consumption of a lower-carbohydrate breakfast meal (relative to a     higher-carbohydrate meal) is associated with a healthier metabolism.   "
9301|NCT03164187|"     The aim of this study is to analyze the efficacy of Diabeton 60 MR as intensive     sugar-lowering therapy into routine clinical practice, in patients for whom the treating     physician has already decided to prescribe this medication. This concerns untreated newly     diagnosed patients uncontrolled by diet, and patients uncontrolled by metformin.   "
9302|NCT03164174|"     The study is a prospective-observational, explorative single-centre cohort study aimed to     examine the atherosclerosis progression in coronary arteries compared to peripheral vessels     (carotids, femoral arteries). Atherosclerotic alterations in peripheral vessels (IMT, plaque     volume, plaque morphology) will be measured with ultrasound (IMT measurements and 3D     quantitative plaque volumetry), whereas atherosclerotic alterations in coronary arteries will     be tested with cardiac computertomography (CT) (coronary artery calcium score, calcium volume     score, plaque morphology).      A total of 55 patients without prior known established vascular diseases will be tested.     Cardiac CT and ultrasonography will be performed initially. After 2 years follow-up CT and     ultrasound examination will be performed to assess the changes in atherosclerotic burden.     Initially and after two years plasma samples will be collected and tested for traditional and     novel cardiovascular risk factors.      The primary endpoint of the planned study will be the correlation of the atherosclerotic     progression between coronary arteries and peripheral arteries (carotids, femoral arteries).      Secondary endpoints will include the correlation of atherosclerotic progression with     established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP,     P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1     (ICAM-1), CETP TaqIb polymorphism), with cardiovascular event rate, and the additional     predictive value of atherosclerotic progression compared to an established risk score (SCORE     Card, FRS). Also plaque morphology will be compared between coronary arteries and peripheral     vessels.   "
9303|NCT03164161|"     The purpose of this study is to evaluate the correlation between β-endorphin levels in blood     plasma and saliva in healthy participants with different pain sensitivity and in those with     acute pain in oral and maxillofacial region.      Expected results        -  Relation between blood plasma and saliva β-endorphins levels        -  Differences of blood plasma β-endorphins levels in healthy participants with different          pain sensitivity and in those with acute pain        -  Differences of saliva β-endorphins levels in healthy participants with different pain          sensitivity and in those with acute pain        -  Objective method of patient's pain sensation evaluation        -  Correlation between patient's self-reported understanding of pain levels in oral surgery          procedures, levels in saliva and blood plasma β-endorphins levels and sensitivity to          cold test results      Study protocol:      Selection of participants        1. Evaluation of pain perception in oral surgery procedures by healthy adult participants.        2. Groups formation, according to the results from first stage, resulting in high and low          pain rating participants groups.        3. Control group formation from patients with acute pain in oral and maxillofacial region          Control rating of participants      1. Patients that have been assigned to groups according to subjective pain ratings in oral     surgery procedures will have to repeat the same questionnaire to ensure the correct group     assignment.      2. Patients that have been assigned to groups according to subjective pain ratings in oral     surgery procedures, will undergo the sensitivity and tolerance to cold pain test.      3. Patients that were assigned to control-acute pain group, will be included in further study     stages only with clinically diagnosed cause of acute pain in oral and maxillofacial region to     avoid possible psychogenic or general diseases pain.      Evaluation of β-endorphins - sampling        1. Saliva samples will be collected by all further included participants by one selves          participants with researchers supervision.        2. Blood samples will be collected from forearm veins by researcher. Evaluation of          β-endorphins - laboratorial examination      1. Levels of β-endorphins in saliva and blood will be evaluated according to manufacturer of     β-endorphins evaluation kit for human research. Every sample will be evaluated twice and the     mean level will be evaluated.      Statistical analysis      1. Statistical analysis will be produced to access all possible relationships   "
9304|NCT03164148|"     Several studies have been reported that heart rate is known to be associated with prognosis     in chronic diseases and acute diseases. For example, a decrease in heart rate following     myocardial infarction may lead to a higher mortality rate. It is also known to predict heart     failure, diabetic neuropathy, and even depression.      The combined pituitary function test artificially induces hypoglycemia to observe the     secretion of pituitary hormone. The degree of change in heart rate during hypoglycemia can     predict the adequacy of the test, and heart rate can be changed according to the     characteristic of the tumor. Also, the prognosis can be predicted based on this.      In our study, we used a licensed device approved by KFDA (Korea Food and Drug Administration)     to measure heart rate variability in patients with pituitary adenoma.   "
9314|NCT03164018|"     Fampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of     walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The     medicinal product has been authorized under a so-called conditional approval scheme. This     means that further evidence on this medicinal product is awaited and this study aims to     assess the effect of Fampyra, administered according to standard clinical practice, on     cognition, fatigue and quality of life in patients with MS.      This clinical study is a multicenter, prospective, non-interventional, cohort study of MS     patients receiving Fampyra in outpatient setting. Patients will be treated according to the     local prescribing information of the study medication and routine medical practice in terms     of visit frequency and types of assessments performed. The assignment of the patient to this     therapeutic strategy is not decided in advance by the study protocol but falls within current     practice and the prescription of Fampyra is clearly separated from the physician's decision     to include the patient in the current study.      Since this is purely non-interventional study, primary data -which will be obtained     prospectively during the study visits through patients' interview and patient reported     outcomes or as performed per standard clinical practice- will mainly be employed.   "
9306|NCT03164122|"     Recently, the emergence of biotherapies has allowed the use of intra-articular injections of     autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the     demonstration that platelets-enriched plasma, by virtue of its growth factors concentration,     stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent     literature highlights that these autologous products are very well tolerated by humans. PRP,     as an intra-articular injection therapy, seems to be an autologous biological medicine,     innovative for cartilage injury reparation and showing good primary results for this     indication.      Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large     proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to     differentiate into several cellular lines in vitro and in vivo, including cartilage cells.      The association of microfat and PRP is interesting in order to potentiate trophic and     regenerative effects on damaged cartilage site. The combination of these two products,     respectively rich in autologous multipotent stem cells and growth factors, aims to create an     optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase     is playing the role of a nutritive support matrix which contains and limits the diffusion and     resorption of PRP liquid while allowing progressive growth factors release on the injection     site.      The hypothesis of this project is that standardized injection of an innovative treatment     (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the     treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative     second line treatment in case of medical treatment failure.   "
9307|NCT03164109|"     This is a partially double-blind study in healthy adult subjects, which will be conducted as     a placebo- and active-controlled, single-dose, crossover study.      Twenty-eight subjects will be enrolled to ensure 24 subjects on all study periods. All     subjects will receive all 3 study treatments (GC4419, placebo and moxifloxacin) in randomized     sequence.      Cardiodynamic assessment using continuous ECG recordings (Holters) will be performed for     approximately 26 hours on the day of dosing (Day 1) in each study period. ECGs will be     extracted serially pre- and post-dose and predefined timepoints at which subjects will be     supinely resting.      Subjects will be supinely resting for at least 10 minutes prior to and 5 minutes after each     nominal timepoint for ECG extraction.      Blood draws for PK will be performed in all periods at the same timepoints and always after     ECG extraction.      Subjects will be domiciled in the clinic from noon/afternoon of the day before dosing (Day     -1) until completion of safety procedures on Day 2 in each study period.      All subjects (including subjects who terminate the study early) will return to the clinical     research unit (CRU) 14 (± 1) days after the last administration of study treatment for     follow-up procedures and to determine if any Adverse Event (AE) has occurred since the last     study visit.   "
9308|NCT03164096|"     Although the exact mechanism remains unknown, the association of pregnancy and decreased     local anesthetic requirement is clear. demonstrated that more local anesthetic is required     for cesarean section under combined spinal-epidural anesthesia in preterm compared with term     patients.   "
9309|NCT03164083|"     Osteoarthritis of the knee is one of the most common causes of disability among elderly. As     the disease progresses the cartilage become frustrated, surrounding bone react to become     thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in     signal density. Patients are treated initially by pain management. In patients who don't     response to first line treatment invasive treatment like total knee replacement is done. The     investigators designed this clinical study with the aim of evaluating therapeutic effects of     intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular     Fraction (SVF) in patients with severe knee osteoarthritis   "
9310|NCT03164070|"     This study evaluates laboratory-based method to estimate the degrees of activity of medium     and large joint osteoarthritis.   "
9311|NCT03164057|"     The overall aim of this study is to determine if epigenetic priming with a DNA     methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries     evidence of a clinical efficacy signal as determined by minimal residual disease (MRD),     event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as     well as total reduction in DNA methylation and outcome assessments will be done to     simultaneously obtain preliminary biological and clinical data for each DMTi in parallel.      PRIMARY OBJECTIVES:        -  Evaluate the tolerability of five days of epigenetic priming with azacitidine and          decitabine as a single agent DMTi prior to standard AML chemotherapy blocks.        -  Evaluate the change in genome-wide methylation burden induced by five days of epigenetic          priming and the association of post-priming genome-wide methylation burden with          event-free survival among pediatric AML patients.      SECONDARY OBJECTIVES        -  Describe minimal residual disease levels following Induction I chemotherapy in patients          that receive DMTi.        -  Estimate the event-free survival and overall survival of patients receiving a DMTi prior          to chemotherapy courses.   "
9312|NCT03164044|"     Current study evaluates the use of the improved Basophil Activation Test (BAT) in the     diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs     (NSAIDs).   "
9313|NCT03164031|"     Walking can be slow and unsteady in people with multiple sclerosis (MS). This study will     investigate whether orthotic shorts might help.      Orthotic shorts are similar to the tight clothing believed to improve performance in     athletes. Research suggests that such shorts help stroke survivors to walk faster. Some     people with MS find that similar garments improve coordination and stability. Public funding     is controversial because there is no research investigating whether they work in people with     MS.      This is a cross-over study in which participants will each trial two different pairs of     shorts. The first aim is to determine whether these shorts are acceptable to people with MS.     Secondly, the study will develop the tools required to test the shorts. For example, by     determining which measures seem most appropriate and if specific factors predict whether the     shorts might help. The hypothesis being tested is that the shorts are acceptable.      People with MS will be invited to participate in this mixed methods study, aiming for a     sample size of 16 people. Participants will trial two different garments: orthotic shorts and     a placebo. The placebo shorts look similar but are less supportive. The shorts will be tested     in a movement laboratory and in daily life.      In the movement laboratory, participants will be measured in both pairs of shorts and in     normal, loose clothing. Walking pattern, speed and variability will be measured when the     shorts are first worn.      Participants will test shorts in their normal daily life for up to two weeks. They will     complete questionnaires about their walking and balance in the different shorts and record     how long they wear the shorts. Interviews will explore expectations and experiences of the     shorts and of the research study.      In the analyses, data from interviews will be combined with the numerical information gained     from laboratory measures, diaries and questionnaires. If the shorts are acceptable, this     study will inform a larger trial investigating effectiveness.   "
17329|NCT03058705|"     The primary outcome of this study is to determine the minimal dwell time needed for adequate     detection of hexaminolevinulate HCL avid tumors using protoporphyrin IX (PpIX) near infrared     fluorescence (NIRF).   "
9316|NCT03163992|"     This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects     with advanced hepatocellular carcinoma as second-line treatment after failure of sorafenib.      Approximately 60 subjects will be enrollment to evaluate the efficacy and safety of     pembrolizumab.      Enrollment will begin with all subjects without regard for PD-L1 expression status.      An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment.      All study subjects will be evaluated every 6 weeks (+/- 7 days) following the date of IP drug     adminstration for the first 12 months and every 12 weeks (+/- 7 days) thereafter until     progression of disease is documented with radiologic imaging (computed tomography or magnetic     resonance imaging).      The primary efficacy endpoint is ORR (objective response rate) per RECIST 1.1.   "
9317|NCT03163979|"     Cisplatin-based chemoradiation (CCRT) has been considered as the standard care for patients     with locally advanced cervical cancer (LACC). Nevertheless, increasingly more radio-resistant     tumors still recur. IMRT including Rapid-Arc have obvious advantage in the dose distribution     and organ protection, and positron emission tomography (PET) with F-18 fluorodeoxyglucose     (FDG) and Comet analysis have good sensitivity for detecting sites and radiosensitivity of     disease. These may be helpful to individualized CCRT of LACC.      Three hundred LACC patients are enrolled in the study, who were with FIGO stages IB2-IVA and     had no para-aortic lymphadenopathy (>10 mm) assessed by PET-CT or MRI. All the patients     received definitive radiotherapy consisting of external beam whole pelvic RT and HDR-ICBT.     The cumulative linear quadratic equivalent dose (EQD2) was 70-75Gy prescribed at point A.     Cisplatin 30 mg/m2 weekly was administered concurrently for 5 courses. 2-4 cycles TP (Taxol     135 mg/m2, D1 and DDP 25 mg/m2, D1-3) regimen sequential chemotherapy were performed if     complete response (CR) not achieved according to magnetic resonance imaging (MRI) or PET-CT     after CCRT. Hypothesis of the study is that CCRT and sequential chemotherapy is safe. Based     on FDG-PET/CT and Comet assay, higher doses can be safely delivered individually to accurate     tumor volume, while the doses to bladder and rectum are relative low. Comet and     FDG-PET/CT-guided IMRT including RapidArc may improve survival in terms of time to     progression (TTP), progression-free survival (PFS) and overall survival (OS) and less     treatment-related toxicity. The data will be observed and analyzed.   "
9318|NCT03163966|"     CR6086 is a new, potent and selective, orally available, small molecule prostaglandin EP4     receptor antagonist, endowed with immunomodulatory properties. The pharmacological properties     of CR6086, along with its oral bioavailability, predictable pharmacokinetics and good safety,     make it the ideal candidate to be tested alone or in combination with methotrexate (MTX) in     patients with early Rheumatoid Arthritis who are naïve to Disease-Modifying Antirheumatic     Drugs (DMARDs). The compound has indeed the potential to provide a safer and more effective     treatment than MTX (or other conventional synthetic DMARDs - csDMARDs), and could     significantly improve the proportion of responder patients and avoid/delay the recourse to     biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs).   "
9319|NCT03163953|"     This study will determine the effect of physical activity promotion based on Thai Physical     Activity Guideline (TPAG) and break in workplace sitting on physical activity level, physical     fitness, body compositions, cognitive functions and cardiometabolic biomarkers in office     workers at Software Park Thailand under the Office of Science and Technology (NSTDA). There     are two intervention including physical activity (PA) coaching based on TPAG and break in     workplace sitting. The investigators will coach participants for promoting daily active life     and participating to monthly exercise programs. The participants will be assign to break in     sitting during daily work.   "
9320|NCT03163940|"     The present study will adopt a non-blinded parallel-group randomized controlled trial design     that involves a Laughter Yoga group (intervention) and a treatment-as-usual group (Control).     It aims to determine the feasibility of using LY intervention on patients with Major     depressive disorder (MDD), and also to evaluate the potential effect of the intervention on     comorbid depression, anxiety and stress for these patients. It is hypothesized that, LY     group, as compared to the TAU group, will have significantly lower symptoms of depression,     anxiety and stress, but greater improvements in self-reported mental health/physical     health-related quality of life immediately post intervention and at 3 months' follow-up.   "
9321|NCT03163927|"     This study will investigate the effect of simulation-based training with mastery learning     (SBML) on novice performers' lumbar puncture (LP) performance in a clinical setting. The     study will investigate the effect on operators' performance, stress level, and on patient     experienced stress, confidence in operator, and patient-related outcomes of pain, and risk of     subsequent Post Dural Puncture Headache (PDPH), and days of sickness leave.      The study will compare the effect of the training to a control group of novices receiving     standard training and additionally to an intermediate and an expert group.      The study will provide insight into the translational effect from the simulation based     setting to clinical performance. Further, the study will explore: if stress decreases     operators' performance; if operators stress affects the patient stress level; and the effect     of SBML on patient-related outcomes.   "
9322|NCT03163914|"     96 pregnant patients will be enrolled in this study. Participants will divide in to 3 groups.     Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all     patients. After performed spinal anaesthesia, vasopressor infusion will be started     intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for     Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group     NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group     P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus     ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20%     of basal value, atropine will apply IV.   "
9323|NCT03163901|"     Test the hypothesis that a certain set of osteopathic manipulation procedures preformed on     patients with mild to moderate traumatic brain injury will result in accelerated rates of     recovery assessed using vestibular function tests, quality of life questionnaires and     measurements of the levels of anti-inflammatory metabolite and protein biomarkers in the     blood and urine.   "
9351|NCT03163537|"     Observation of disturbing factors in the operating room and comparison between day and night     shift. The investigators have chosen to observe kidney transplantations, since this type of     operation has the same priority during day and night. Stress levels of surgeons will be     measured using the HealthPatch.   "
9324|NCT03163888|"     Total knee arthroplasty (TKA) is a well-established modality for the treatment of advanced     knee osteoarthritis with high satisfaction rate. However, the traditional cutting jigs for     distal femur cutting inevitably violates the medullary canal of femoral bone. The process of     intramedullary reaming for the insertion of distal femur cutting jigs stimulated the     dissipation of marrow emboli that reported lead to increased risk of myocardial infarction or     cardiac stress perioperatively. There are emerging refinements aiming to reduce the insult to     the medullary canal of the distal femur as well as to improve the prosthetic alignment, such     as navigation assisted TKA or robotic surgery.      In addition to better prosthetic alignment, computer-assisted navigation TKAs also mitigate     perioperative blood loss and systemic emboli. The publication previously published by the     investigators showed that navigation TKAs can lead to lesser extent of elevation of     endothelial injury markers than the traditional TKAs. However, the detrimental effects of     intramedullary reaming seem to be multi-dimensional and the whole picture has not been     elucidated clearly at present.      Previous studies have shown that operative trauma can trigger marked immune responses.     Operative procedures can simultaneously stimulate the pro-inflammatory and anti-inflammatory     response, with 80% of the leucocyte transcriptome being affected. Most studies of hip or knee     surgery found that operation-triggered immune reactions are associated with postoperative     recovery, infection, and even mortality.      The navigation TKAs avoid the process of intra-medullary reaming, which is the mandatory part     of conventional TKA for the distal femur cutting. The investigators hypothesize that the     reaming process may exert substantial inflammatory response, which can be manifested by     higher level of inflammatory markers in the serum and hemovac drainage samples obtained from     the participants undergoing conventional TKAs.   "
9325|NCT03163875|"     Urticaria is one of the most frequent presenting complaints in dermatology, allergy, and     emergency departments. The term chronic urticaria (CU) is understood as the appearance of     recurrent wheals more than twice a week for over 6 consecutive weeks .Urticaria is not a     single disease but a reaction pattern that represents cutaneous mast cell degranulation,     resulting in extravasation of plasma into the dermis. The incidence of chronic urticaria is     unknown, but it is thought to occur in 0.1%-3% of the population   "
9326|NCT03163862|"     This is a controlled preminary trial intended to increase the implantation rate of IVF     cycles, by using more than one known procedure, endometrial scratching, evaluating the status     of the adhesive factors as αVβ3 integrin, L-selectin ligand MECA-79, E-cadherin and ICAM-1,     as a determinant for intervention by G-CSF, according to a score that can be done on a small     sample obtained during scratching, then give G-CSF for the scores less than 4 intrauterine     and subcutaneously.   "
9327|NCT03163849|"     Chronic hepatitis C virus infection affects an estimated one hundred and seventy million     people around the world with and approximate prevalence 0.2-2 % in the United State of     America and European countries.   "
9328|NCT03163836|"     Current European Society of Cardiology Guidelines recommend concomitant atrial fibrillation     (AF) ablation for all symptomatic patients undergoing other cardiac surgeries, but the safety     and potential benefits of concomitant atrial fibrillation (AF) ablation at the time of double     valve replacement remains unexamined. A retrospective review of patients with AF who     underwent double valve replacement with or without concomitant surgical ablation in our     institute starting from April 2006.   "
9329|NCT03163823|"     This study will enroll 75 mechanically vented adults in the ICU to compare self-reported ease     of communication, patient satisfaction, and patient anxiety and frustration levels between a     group using a communication application on an iPad and a group using standard methods of     communication while mechanically vented.   "
9330|NCT03163810|"     The purpose of this study is to determine whether low level laser therapy (LLLT) using the     Erchonia VERJU and EVRL laser devices is effective in reducing aminoalanine transaminase     (ALT) levels in individuals with nonalcoholic steatohepatitis (NASH).   "
9331|NCT03163797|"     Head and neck cancer (HNC) continues to be a significant health care problem in Taiwan and     oropharyngeal squamous cell carcinoma (SCC) is the common subtype. With the concern of organ     preservation in recent years, concurrent chemoradiation is the major treatment modality for     oropharyngeal SCC. Endoscopy with biopsy serve as the main diagnostic tools in patients with     oropharyngeal SCC. While computed tomography (CT) and magnetic resonance imaging (MRI) are     commonly used to evaluate the tumor extent of HNC, MRI is more preferred in the oropharyngeal     area by virtue of its high contrast resolution. With the advance of MRI technology, whole     body MRI is now possible, and functional techniques become more feasible in the head and neck     region, including diffusion-weighted imaging (DWI) which comprises of monoexponential DWI,     IVIM (intravoxel incoherent motion) model and Kurtosis (biexponential or non-Gaussian     fitting), and perfusion-weighted imaging (PWI) become feasible. Therefore, MRI can evaluate     distant site status of HNC in the single examination session and provide biologic information     of tumors, such as cellularity, angiogenesis and permeability, and so forth. Positron     emission tomography/CT (PET/CT) is another common imaging modality to evaluate HNC, because     of its ability to provide whole-body anatomic and metabolic information.      Integrated PET/MRI is a novel imaging technology that combines PET and MRI in one single     scanner. It can acquire both PET and MRI information simultaneously. Initial data convey that     PET/MRI performed favorably in diagnostic evaluation of HNC. However, the predictive value of     PET/MRI in treatment outcome of HNC has not been reported. A prospective study of integrated     PET/MRI in a large cohort of patients with specific tumor origin and uniform treatment     protocol is needed to fully validate the clinical usefulness of this novel integrated system.      In this 3-year prospective study, the investigators will take the advantages of integrated     PET/MRI scanner with diffusion-weighted MRI (DWI) and dynamic contrast-enhanced perfusion     weighted MRI (DCE-PWI) to evaluate our 160 patients with oropharyngeal SCC subjected to     chemoradiation. Non-contrast chest CT will also be performed on the same day. The     investigators aim to (1) determine whole-body staging/restaging accurately, (2) predict     treatment response and prognosis, and (3) to determine necessity of noncontrast chest CT. The     investigators expect that this project will offer the validation of usefulness of integrated     PET/MRI in tumor staging/restaging of oropharyngeal SCC and resultant clinical impact. The     role of noncontrast chest in the workup with our PET/MRI protocol can be defined. It will     also provide evidence about how and to what extent the various simultaneously acquired MRI     and PET functional parameters can help prediction of treatment response and prognosis, which     are important in timely modification of treatment regimen.   "
9332|NCT03163784|"     SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the     safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on     stable antiretroviral therapy (ART).   "
9333|NCT03163771|"     The principal aim of the study is to avoid the diagnostic wanderings of patients suffering     from a peroxisomal disorder. For this purpose, a new diagnostic strategy is proposed. It     rests on functional metabolic explorations and gene studies directly connected to a     first-line enlarged physico-chemical detection of metabolites from peroxisomal origin in     clinically suspect patients.   "
9334|NCT03163758|"     The study aimed to figure out brain structural and functional reorganization evidence after     repetitive transcranial magnetic stimulation through the method of neuroimaging brain network     analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor     imaging.   "
9335|NCT03163745|"     Spontaneous bacterial peritonitis is defined as the presence of an infection in a previously     sterile ascites in the absence of an intra-abdominal source of infection or malignancy .      The variants of Spontaneous bacterial peritonitis includes - (i) Classic Spontaneous     bacterial peritonitis: -ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3     and positive culture. (ii) Culture negative neutrocytic ascitis but the ascitic fluid     polymorphonuclear leukocyte counts more than 250/mm3 and (iii) Bacterascites: - a culture     positive ascitic fluid but the polymorphonuclear leukocyte counts less than 250/mm3   "
9336|NCT03163732|"     The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to     compare the clinical relevance of a large Next-generation sequencing (NGS) panel     (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients     with advanced solid tumors.      This study will allow adapting the therapeutic management of these patients, if needed, by     giving them recommended therapies (commercialized or in ongoing clinical trials), based on     the recommendations of the Molecular Tumor Board (MTB).   "
9337|NCT03163719|"     Defining the origin of a seizure remains a difficult diagnosis. The presence of witness is     not systematic, the clinical examination can be little contributory, and the delay     recommended by the FSN is often surpassed for the realization of Creatine kinase (4h). In the     event of a suspected seizure, an initial blood test with Creatine kinase and Lactates is     often done on admission of the patient in other words before the 4hours delay.      It seems interesting to harmonize the practices, to limit the patient wait in the emergencies     for a deferred dosage of CK at 4 hours from the seizure and to identify an early biological     marker.      Objectives:      To evaluate the value of blood CK and Lactate dosage in emergency procedures in the diagnosis     of generalized seizures.   "
9338|NCT03163706|"     The main objective of this study is to assess whether attention deficits and executive     functions in patients with schizophrenia are general (semantic and response conflict) or     specific (semantic or response conflict).   "
9339|NCT03163693|"     The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I     and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery     bypass Grafting.   "
9340|NCT03163680|"     Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding   "
9341|NCT03163667|"     Phase 2 Study Comparing CB-839 i with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in     Patients with Advanced or Metastatic RCC   "
9342|NCT03163654|"     The aim of this study was to assess the clinical efficacy of the acellular porcine derived     collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of     multiple adjacent gingival recessions (MAGR). The primary objectives of the study were to     evaluate mean and complete roots coverage. Additionally, the secondary objective was to     evaluate and compare the clinical effectiveness of PADM and SCTG for the treatment of MAGR     defects applying modified coronally advanced tunnel technique (MCAT).   "
9343|NCT03163641|"     This is a prospective, randomized (Reading Center), masked, controlled study in up to 45     subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm     well or trephine at the time of surgery to ensure consistency of the size of the ablation     area.   "
9344|NCT03163628|"     ANTOINE is a prospective trial which aims to assess diagnostic performance of 7 biomarkers     for the diagnosis of severe bacterial infections (SBI) in children aged from 7 days to 36     months.      Fever is a frequent cause of consultation in pediatric emergency departments. Clinical     diagnostic tools are rare and discrimination between severe bacterial infection and viral     infection is difficult to confidently state. The prevalence of severe bacterial infections     (IBS) varies from 10 to 25% according to the studies. Biological markers such as     procalcitonin (PCT) and C-reactive protein (CRP) are commonly used in clinical practice.     These markers have bacterial specificity but share a wide range of values with viral     infections and do not make it possible to exclude or to confirm definitively the diagnosis of     IBS. The use of new markers to improve the diagnosis of bacterial and viral infections is     increasingly studied in adults. The diagnostic value of these new markers has been     demonstrated by associating their dosage with that of CRP for example. This is the case for     IP-10, TRAIL or MxA. However, very few pediatric studies have been carried out to date on     these new biomarkers. However, in pediatrics, these diagnostic tools based on the combination     of biomarkers to discriminate against viral and bacterial infections could be a major help in     the suspicions of IBS. 7 biomarkers were selected to be evaluated in this study. This study     is designed to determine the best biomarkers combination for the SBI diagnosis on a cohort of     800 patients.   "
9345|NCT03163615|"     The purpose of this study is to evaluate the effect of Tibet Rhodiola Capsule on hypoxia and     the cardiovascular risk factors in patients with mild to moderate OSA.   "
9346|NCT03163602|"     The aim of this randomized controlled study is to evaluate the outcome of surgical treatment     of peri-implantitis with and without the use of a bone substitute graft covered by a collagen     membrane. There will be a follow up period of 12 months. Outcome measures will include     assessments of inflammation, probing depth, recession, radiological parameters and PROMs.   "
9402|NCT03162861|"     To assume that lumbar plexus-sciatic nerve block combined with sevoflurane can effectively     diminish the incidence of cognitive dysfunction in elderly patients after hip arthroplasty.   "
9403|NCT03162848|"     The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a     SystemCHANGE™ intervention to improve medication adherence in older adults with heart     failure. The intervention focuses on changing the individual's environment by incorporating     medication taking into existing routines using small experiments with feedback, and receiving     support from people who impact routines.   "
9347|NCT03163589|"     Perinatal hypoxic-ischaemic encephalopathy occurs in one to three infants per 1000 term     births, and up to 12 000 infants are affected each year in the united state of America.     Hypoxic ischemic encephalopathy is not preventable in most cases, and therapies are limited.     Hypothermia improves outcomes and is the current standard of care. Yet clinical trials     suggest that 44% to 53% of infants who receive hypothermia will die or suffer moderate to     severe neurological disability. Therefore, novel neuroprotective therapies are urgently     needed to further reduce the rate and severity of neurodevelopmental disabilities resulting     from hypoxic ischemic encephalopathy.      Erythropoietin is a novel neuroprotective agent, with remarkable neuroprotective and     neuroregenerative effects in animals. Rodent and primate models of neonatal brain injury     support the safety and efficacy of multiple erythropoietin doses for improving histological     and functional outcomes after hypoxia-ischaemia.   "
9348|NCT03163576|"     Hyperphosphatemia is a common complication of end-stage renal disease and particularly     affects haemodialysis patients. Elevated serum phosphorus contributes to the development of     secondary hyperparathyroidism, Mineral bone disorders,metastatic calcifications and calcific     uremic arteriolopathy. There is a significant association between hyperphosphatemia and     increased morbidity and mortality in end stage renal disease patients including     cardiovascular morbidity and mortality ,also it's associated with hospitalization of     haemodialysis patients.   "
9349|NCT03163563|"     The purpose of the study is to measure patient- temperature in the perioperative period of     patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate     if active warming with self-warming blanket (Easywarm®) is as effective as active warming     with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods     is effective in preventing perioperative hypothermia.   "
9354|NCT03163498|"     Introduction: Sleep disturbances may contribute to impairments in mood, occupational and     intellectual performance, and social relationships, as well as being associated with     cardiovascular diseases, such as arterial hypertension. Sedentary lifestyle has often been     associated with poor sleep quality and hypertension; regular exercise has been studied as a     coadjuvant therapy for hypertension and/or for some sleep disorders. Objective: To compare     sleep pattern of active and inactive patients with arterial hypertension, as well as to     evaluate complaints of depression and anxiety, and the mood profile. Material and Methods:     Polysomnography, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale will be used to     assess the sleep pattern. Depression will be assessed by the Beck Depression Inventory (BDI),     Beck Anxiety Inventory (BAI) anxiety, and mood pattern by the State of Mood Profile (POMS).     The level of physical activity will be recorded by the number of steps taken (pedometer).     Participating in the study will be 60 hypertension patients (ACTIVE, n=30; INACTIVE, n=30).     Hypothesis: Active hypertensive patients better quality of sleep, better mood profile, and     fewer complaints of depression and anxiety when compared to physically inactive hypertensive     patients.   "
9355|NCT03163485|"     This clinical trial evaluates the safety and diagnostic performance of a newly developed     combined catheter that will be implanted into the brain of patients with severe brain injury     for short time (up to 28 days) monitoring of the electric activity and the metabolism of     brain tissue at risk. Ten patients will be monitored with the new device and seven patients     will be monitored by intracerebral probes according to standard treatment.   "
9356|NCT03163472|"     Axillary brachial plexus block is an safe, effective and widely used technique for providing     surgical anesthesia at and below the elbow. Inadvertent intraneural and intravascular     injections are the only significant risks. Traditionally, greater volumes of local     anaesthetic have been administered to achieve successful axillary brachial plexus block, but     recent studies have demonstrated that this can be achieved with even very low volumes of 2-4     mL lidocaine 1.5% per nerve or ultra low volume of 1 mL lidocaine 2% per nerve.      Administration of 30mL (vs 10 mL) lidocaine 2% with epinephrine 1:200 000 prolongs the     sensory and motor block duration of ultrasound guided axillary brachial plexus block for     elective upper limb surgical procedures.      Primary Outcome:      The primary outcome will be the overall duration of sensory block.      Secondary Outcomes:      Duration of motor block Time to onset of the block. The quality of block intra operatively     Time to first request of postoperative opioid analgesia. Total opioid consumption at 24     hours. The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus,     vomiting, convulsions or arrythmia.   "
9357|NCT03163459|"     To determine the efficacy and safety of short-duration intra-artery selective brain cooling     in addition to mechanical thrombectomy in patients with acute ischemic stroke.   "
9359|NCT03163433|"     The aim of the study is to examine the potentials of involving patients with metastatic     melanoma in their own care planning through systematic use of patient-reported outcome     measures (PROM). Furthermore, to examine the outcome of health-related quality of life,     self-efficacy and impact on the patient-physician interaction.      Patients (N=282) will be included from three highly specialized hospitals in Denmark. At one     hospital patients will complete PROM before each consultation during a year (intervention     group). At the two other hospitals patients will not complete PROM (control group). In     addition to baseline, measurements will take place after three, six and 12 months. The     project is organized and executed with patient involvement in the research process.   "
9360|NCT03163420|"     The aim of this clinical trial is to evaluate the effect of pre-operative administration of     diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine     anaesthetic agent in patients with symptomatic irreversible pulpitis.   "
9361|NCT03163407|"     Prospective, randomized study, including full term parturients scheduled for caesarean     section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a     25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the     spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were     recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as     decrease of Systolic blood pressure>20% from the baseline value, was managed using Ephedrine     increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients     of GN group. Intraoperative hemodynamic data of the 2 groups were compared.   "
11672|NCT03133130|"     Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in     Healthy Male Volunteers   "
9377|NCT03163199|"     Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios     (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for     symptomatic lower extremity peripheral arterial disease.      Secondary objectives:        -  Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following          endovascular therapy        -  Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in          TLPGS        -  Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and          TLPGs        -  Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional)          and TLPGs   "
9378|NCT03163186|"     To evaluate the safety, advantages, and appropriateness of performing transarterial hepatic     emobolization of liver cancer via arterial access from the radial artery versus conventional     transfemoral arterial access. The procedures that will be followed utilizing arterial access     include transarterial chemoembolization (TACE), specifically performed for hepatocellular     carcinoma, and transarterial embolization (TAE) which is performed for types of liver tumors     such as carcinoid tumors or liver metastases.   "
9362|NCT03163394|"     Urinary tract infections (UTIs) are a common cause of bacteremia and serious bacterial     infections in young children (2-24 months of age). Because these children are usually unable     to say what symptoms they are experiencing, UTIs are diagnosed through testing. Current     testing of urine samples require a catheter or suprapubic aspiration performed for urine     collection for infections markers to be reliable. Bag specimens often have varying results     that can be poor in sensitivity and specificity depending on what component of the urine test     one is looking at. Catheter and aspiration testing can be anxiety-provoking to parents, be     painful for patients and even introduce bacteria into the bladder. An antimicrobial peptide     called alpha human defensin-5 (HD5) is produced by the uroepithelium in response to     infection. HD5 has been studied in the urine and does increase in actual UTIs. This study     will look at children 1 to 24 months of age and again study levels of HD5 in culture positive     UTIs versus urine negative for UTI. This study will also determine if collection method     alters HD5 levels. We will measure HD5 levels in the urine from a bag specimen and a catheter     specimen in the same patient.      Our primary objective is to determine the sensitivity and specificity of HD5 measured in     urine collected by bag and catheter in the same patient for the diagnosis of UTI in children     between the age 1 to 24 months presenting with febrile illness and suspected UTI.   "
9363|NCT03163381|"     Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting     ,single center, one-armed clinical study.   "
9364|NCT03163368|"     The purpose of this study is to study if giving radiation to a brain tumor (a procedure     called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep     brain tissue healthy, while possibly eliminating the need to return for radiation once a     patient has healed from neurosurgery. This study will also seek the best radiation dose on a     brain tumor based on how well the radiation therapy works and asses the side-effects.   "
9365|NCT03163355|"     The texture of the pureed diet is likely to be most useful factor predictive of the     prevention of aspiration pneumonia. However, it has not been previously reported what kinds     of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing     evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture     of pureed diets in elderly patients with severe dysphagia.   "
9366|NCT03163342|"     This is an open-label, single administration dose study in adult healthy male and female     subjects. After qualifying for the study, subjects will receive a single intramuscular     injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.   "
9367|NCT03163329|"     Previous trials have shown that TAVR was a noninferior alternative to surgery in patients     with severe aortic stenosis at intermediate surgical risk. However, patients with congenital     bicuspid valve have been excluded in those trials. The purpose of this trial is to determine     the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve     stenosis.   "
9368|NCT03163316|"     Breast cancer is the most common cancer among women worldwide.The main cause of cancer     related death is the invasion and metastasis. The usual site of spread outside the breast is     to lymph nodes in the axilla.   "
9369|NCT03163303|"     This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use     and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use.     Both groups will be offered a nicotine patch starter kit. The primary outcome is verified     7-day point prevalence abstinence from smoking at 3, 6, and 12 months.   "
9370|NCT03163290|"     Patellofemoral Pain (PFP) is one of the most common disorders that affecting the physically     active population, and its incidence is higher among women. Despite the high incidence, the     etiologies of this painful syndrome are still unclear. Research has verified the influence of     hip stabilizers on knee injurie and has demonstrated a deficit of strength of the hip lateral     rotator, abductors and extensors muscles in patients with PFP. The aim of this study is to     compare the effectiveness of strengthening the Posterolateral Hip Complex with the     Anteromedial Hip Complex associated with quadriceps strengthening for pain reduction and     improvement of functional capacity in patients with PFP.   "
9371|NCT03163277|"     Neurocognitive disorders are still highly prevalent in the HAART era; despite a dramatic     reduction in dementia cases, 15-50% of patients may develop mild or asymptomatic     neurocognitive disorders (HIV-associated neurocognitive disorders, HAND).      Among other hypothesis neurotoxicity of antiretrovirals has been postulated but its impact is     unknown.      Our hypothesis is that using drugs with reduced in vitro neurotoxicity may improve cognition     in HIV-positive patients withHAND.      76 patients with HAND will be randomized to either continue their treatment or switch to     emtricitabine, darunavir/cobicistat, maraviroc. Patients will be re-tested 6 months later.   "
9438|NCT03162393|"     Brachial plexus avulsion injury (BPAI) caused by traction injury, especially total root     avulsion, represents a severe handicap for the patient. Despite recent progress in diagnosis     and microsurgical repair, the prognosis in such cases remains unfavorable. We need to find an     relatively optimal surgical treatment.   "
10016|NCT03154840|"     1. Compares and evaluates the relative bioavailability of single-dose subcutaneous          administration of each of the Eutropin formulations to healthy male volunteers.        2. Ensure safety and tolerability of single, subcutaneous administration of Eutropin          formulations to healthy male volunteers.   "
9372|NCT03163264|"     The MTG intervention uses a new MTG software tool delivered on tablets to facilitate     5As-based weight management counseling with a health coach and the VA PACT healthcare team to     promote goal-setting, behavior change, and weight loss in the primary care (PC) setting. The     MTG intervention also includes 10-15 health-coaching calls to the patient over 12 months.      As part of a cluster-randomized controlled study, the investigators will randomize 10 PACT     teams at the Brooklyn VA to receive either the MTG Intervention or an Enhanced Usual Care     control. The primary aim of the study is to explore differences in feasibility,     acceptability, and intermediate, behavioral, and weight loss outcomes at 3, 6 and 12 months     of 520 patients recruited from the randomized PACTs.      Objective:      1) Explore the feasibility and impact of this intervention on intermediate, behavioral, and     weight loss outcomes at 3, 6 and 12 months post-intervention when compared to enhanced usual     care.   "
9373|NCT03163251|"     This study evaluates the effect of peer facilitated monthly small group topic-based small     group discussions on various themes common to physician training that pertain to aspects of     humanism on rates of burnout. Attendance to these sessions and completion of the surveys is     voluntary.   "
9374|NCT03163238|"     Cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by     extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit,     endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation,     ischemia-reperfusion injury of myocardium) factors. This may either be mild or lead to a more     severe clinical condition. Inflammation after pediatric open heart surgery is a parameter     affecting also duration of mechanical ventilatory support. Dexmedetomidine use was associated     with a reduced increase in plasma IL-1, IL-6, TNF-a, and INF-g levels   "
9380|NCT03163160|"     Pelvic floor muscle physical therapy is recommended in clinical guidelines for women     dyspareunia and pelvic pain. This study compare pelvic floor manual therapy and intratissue     percutaneous electrolysis (EPI) technique in the treatment of pelvic pain in women with     dyspareunia. Half of participants will receive pelvic floor manual therapy while the other     half will receive intratissue percutaneous electrolysis technique.   "
9381|NCT03163147|"     Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count     (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for     unknown reasons , leading to stimulation of the immune system , autoantibody production, and     platelet destruction In recent years ,the list of etiologies of ITP has been steadily     increasing, so the term idiopathic is becoming obsolete, increasingly replaced by     immuneTP .      Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy .     the terminology of corticosteroid-dependence means The need for ongoing or repeated doses     administration of corticosteroids for at least 2 months to maintain a platelet count at or     above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are     considered non responders   "
9382|NCT03163134|"     The overall purpose of this study was to assess the necessity of lumbar drain placement after     endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak     postoperatively and promote a standardization of its use.   "
9383|NCT03163121|"     This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically     attenuated PfSPZ) in healthy malaria-naïve adult volunteers. This Phase 1 trial is divided     into two stages, Stage A and B. Stage A is an open label, single center, dose escalation     study in 19 volunteers. Stage B is a multi-center, double blind, randomized,     placebo-controlled trial in 48 volunteers. The primary objective of this study is to     determine the safety and tolerability of direct venous inoculation (DVI) of PfSPZ-GA1 Vaccine     in healthy adults.   "
9384|NCT03163108|"     Two-center, randomised controlled, cross-over clinical trial in preterm infants born at     gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support     (Continous positive airway pressure (CPAP) or Non-invasive Ventilation (NIV) or Invasive     Ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2)     will be tested against RMC supported by closed-loop automatic control (CLAC) with     slow-algorithm and RMC supported by CLAC with fast-algorithm.      The primary hypothesis is, that the use of the faster algorithm results in more time within     arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate     hypothesis is, that the faster algorithm is equally effective as the slower algorithm to     maintain the SpO2 in the target range.   "
9385|NCT03163095|"     This is a prospective randomized clinical study. The study will comprise the randomized     decision to either A) primarily close the fascia after laparotomy for intra-abdominal     infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary     abdominal closure (TAC) device (OPEN) with a vacuum drain.      Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current     suggested standard of care. Thus, high quality data to direct clinical decision making in     this highly lethal condition is urgently required.   "
9386|NCT03163082|"     The investigators are interested in typical couple interactions and health behaviors. In     particular, the investigators are interested in different ways that each partner in a coupled     relationship reacts to and understand each other's behavior, and in their health behaviors.   "
9387|NCT03163069|"     A clinical trial to test the effect of whitening toothpaste on teeth color during bleaching     process.   "
9388|NCT03163056|"     The present research project aims to develop an innovative and empirically validated     intervention protocol for smoking cessation among patients with depressive symptoms. For this     purpose, two smoking cessation treatments tailored for managing depression will be compared     with a standard smoking cessation treatment. Participants will be assigned to one of the     following three treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation     (CBT); 2) CBT plus Behavioral Activation (BA); 3) CBT+BA+ Contingency Management (CM).      The main goals are:      1. To assess abstinence rates in each of the above-mentioned treatment conditions conditions     at short and long-term follow-ups: post-treatment, once during the first three months, and at     at six after post-treatment.      1. To assess the effectiveness (relapse rate) of each treatment condition at short and     long-term follow-ups: post-treatment, once during the first three months,and at six after     post-treatment.      3. To analyze efficiency (cost-efficacy) and feasibility of the treatments to a community     setting.      4. To analyze the moderating effect of individual variables over treatment outcomes. In     particular, moderating variables will be: sociodemographic characteristics, severity of     nicotine dependence, severity of depressive symptomatology and impulsivity.      The study hypothesis are:      1-Adding a voucher-based CM component to CBT+BA will enhance abstinence rates and decrease     both short and long-term relapse rates.      2. Providing smoking cessation treatments that include a mood management component (BA or     BA+CM) will have a positive impact in ameliorating depression.      3. Certain individual variables (e.g., gender, nicotine dependence and depression severity     and impulsivity) will have a moderating effect on treatment outcomes.      4. Both CBT+BA and CBT+BA+CM will prove cost-effectiveness and thus may be generalized to a     clinical and community context.   "
9389|NCT03163043|"     Nutritional requirements for dietary amino acids in children have traditionally been     determined utilizing the nitrogen balance technique, which is prone to underestimating     protein requirements. As a result, there is a need to re-evaluate recommendations in order to     characterize how dietary amino acid needs may be modulated by physical activity in healthy,     active children. The purpose of this study is to measure the protein requirement in children     (boys and girls) using the IAAO technique in the presence of a variable intensity exercise     stimulus. It is hypothesized that the present study will deem current amino acid requirements     to be underestimates of appropriate amino acid requirements for this population.   "
9390|NCT03163030|"     The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve     stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with     symptomatic heart failure with preserved and mid-range ejection fraction.   "
9391|NCT03163017|"     The purpose of this study is to determine if use of new imaging technology termed 3D     fluoroscopy will lead the surgeon to change the position of the fractured bones to a more     accurate position.   "
9405|NCT03162822|"     Caregivers and their child are being asked to participate because the investigators are     interested in typical caregiver-child interactions and health behaviors. In particular, the     investigators are interested in different ways that caregivers react to and understand their     young children's behavior, and their health behaviors.   "
9392|NCT03163004|"     Since sedentary time is related to various health outcomes and is already highly prevalent in     childhood and adolescence, effective strategies are needed to tackle this health problem.     Children and adolescents spend the majority of the day in a classroom while sitting at a     desk. Therefore, the classroom is an important setting for implementing specific strategies     to reduce sedentary time.      One of the strategies that gained more attention during the past years is replacing     traditional desks and chairs with standing desks.      This project evaluates the implementation of standing desks in primary and secondary schools     via a clustered randomized controlled trial using an intervention and control condition.     Effects on sedentary time during in class, sedentary activities during leisure time, breaks     in sedentary time, and related determinants (secondary outcomes) are evaluated.      Next to effect evaluation, it is also equally important to evaluate how teachers and pupils     perceive this change in the classroom environment. Both groups need to be positive in order     to obtain the adoption and sustainability. Therefore, focus groups with pupils and interviews     with teachers are conducted, with a specific focus on the perceived barriers. Moreover, the     process evaluation is conducted quantitatively as well by using questionnaires in pupils and     teachers.      The project results will lead to recommendations on how to broadly implement standing desks     into primary and secondary schools.   "
9393|NCT03162991|"     Overview- In this study, overweight or obese, sedentary participants (age=35-55 years, n=20)     will be randomized to a 12-week control period or an aerobic exercise intervention. Those     randomized into the control group will then complete the exercise intervention subsequently.     The planned energy expenditure per week of exercise will be 10-12 kilocalories per kilogram     of body weight per week. Participants will complete three non-consecutive exercise sessions     per week. Body weight, resting metabolic rate via indirect calorimetry, peak oxygen     consumption (VO2peak) through graded exercise testing, fasting blood samples, CGM, sleep and     dietary habits via self-report, and physical activity monitoring will be completed at prior     to and following the aerobic exercise intervention.   "
9394|NCT03162978|"     The purpose of this study is to research the effects of exercising at high intensities for     short periods of time on exercise tolerance and motivation.   "
9395|NCT03162965|"     The investigators propose to improve HIV prevention and care through expanding HIV testing     options to include self-testing for young women, their peers and their sex partners, and by     facilitating linkage to care.   "
9396|NCT03162952|"     The RAND approach to appropriateness makes it feasible to take the best of what is known from     research and apply it—using the expertise of experienced clinicians—over the wide range of     patients and presentations seen in real-world clinical practice. The major limitation of the     RAND approach, however, is that it still utilizes a limited definition of appropriateness;     one that relies heavily on safety, efficacy and effectiveness. Until now the RAND method has     not included patient preferences or resource utilization effectiveness. These are both     serious absences. In the past decade we have seen an evolution in outcome measures from     clinician based objective measures to patient-centered and subjective measures. The     development of Patient Based Outcome Assessments (PBOA); Patient Reported Outcomes     Measurement Information System (PROMIS) and the recent establishment of Patient-Centered     Outcomes Research Institute (PCORI) all contest to the growing importance of the patient's     perspective in determining outcomes and therefore also appropriateness. In the Center, we     propose to advance appropriateness methods by adding three additional dimensions to the RAND     appropriateness methods: patient outcomes, patient preferences and cost   "
9397|NCT03162926|"     The purpose of this trial is to test if VC-02™ combination product can be implanted     subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4)     months.   "
9398|NCT03162913|"     This study is being conducted to assess the effect of dietary strawberry supplementation on     cognition and mobility in obese middle-aged and older adults. It is hypothesized that plant     compounds, present in strawberries, may improve cognition and mobility.   "
9399|NCT03162900|"     This is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic     exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects.     This is a randomized, double blind, positive and placebo controlled study with a 6 day     washout between successive periods.   "
9400|NCT03162887|"     This pilot clinical trial studies how well an educational module and decision counseling     program works in increasing mammography screening rates in formerly homeless women with     serious mental illness. An educational module and decision counseling program may be an     effective tool and have the potential to help with early detection and treatment.   "
9401|NCT03162874|"     This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of     concept in subjects with PD treated with a stable dose of levodopa who are experiencing both     end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)   "
9404|NCT03162835|"     The scientific objective of this research implies developing and examining the clinimetric     properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) in healthy     children.      A total study sample of 60 healthy children (30 from 2nd and 3rd primary school) will be     included to measure test-retest reliability of the Pediatric Neurophysiology of Pain     Questionnaire (PedNPQ). Children will be asked to fill in the questionnaire twice, with a     time interval of 48 hours (assessment T0 and T1).      In order to assess concurrent validity of the PedNPQ, 30 children (15 from 2nd and 3rd     primary school) as well as their parent will receive a pediatric Pain Neuroscience Education     (PNE) session. It is hypothesized that if the developed PedNPQ is valid, children who     received PNE will perform better than children receiving no PNE.      To reduce the participant's workload, all assessments will be done immediately after the     school hours or during recreation, in the primary school of the participant.   "
9406|NCT03162809|"     Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum     analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to     continue analyzing aspects of the performance of salivary hormone competitive immunoassays     for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone     levels will be monitored during treatment cycles for infertility.   "
9407|NCT03162796|"     The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in     participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and     symptoms of PsA.   "
9408|NCT03162783|"     The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic     activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects     with dry eye syndrome.   "
9409|NCT03162770|"     This protocol of meditation is based on mindfulness program proposes to train meditation     during the hemodialysis session. The investigators hypothesize that this program offered     during hemodialysis session may promote well-being, reduce symptoms of stress and depression     reported by the patients, which ultimately may improve biochemical parameters resulting from     better adherence to treatment. Objectives: To evaluate the effects of mindfulness meditation     practice in patients on chronic hemodialysis, in order to verify if this training can improve     symptoms of depression, stress, quality of life and sleep disturbances. Methods: fifty     patients will be separated in two groups, twenty five each group, half of them in the control     group (CG) and the other half to the intervention group (IG). The patients will be evaluated     pre- and pos-protocol.   "
9410|NCT03162757|"     The aim of this pilot study is to establish the success rate of catheterization of the lower     jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is     to compare the two techniques and to determine the best design for a full study (superiority,     non-inferiority). This is a 2-arm randomized control study. The randomization ensures the     comparability of the groups and allows evaluation of the feasibility and potential bias for     further comparative studies.   "
9411|NCT03162744|"     Suicidal intentionality is generally stronger among the elderly, suicidal acts are more     violent and are combined with a greater physical fragility. The suicide of an older adult is     a situation that often leads to helplessness feelings.      Analysis of the literature reveals two types of major interventions in order to reduce     suicide rate: reducing risk factors and increasing protective factors. Risk factors are well     documented, particularly from studies using psychological autopsies. However, protective     factors are much less studied for the elderly. Yet the identification of relevant and     available protective mechanisms in a suicidal crisis is essential to effectively guide nurses     and health professionals in therapeutic commitment and intervention.   "
9412|NCT03162731|"     This pilot clinical trial studies the side effects of nivolumab, ipilimumab and radiation     therapy in treating patients with stage IVA-B head and neck cancer. Monoclonal antibodies,     such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and     spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with     stage IVA-B head and neck cancer.   "
9413|NCT03162718|"     The paradigm of pre-operative exercise as a neoadjuvant therapy to reduce morbidity is     increasingly promoted within general surgery and surgical oncology.      Patients with lung cancer participating in pre-operative exercise have better aerobic     capacity and pulmonary function and shorter hospital length-of-stay after surgery.     Additionally, pre-operative exercise may increase the likelihood of resuming exercise     post-surgery, thereby accelerating the pace of rehabilitation and recovery.      In order to translate the research findings into sustainable clinical practice,     clinician-scientists need to develop pragmatic and effective home-based exercise protocols.     Wearable fitness devices offer a way to approximate the supervision that occurs in exercise     research.      Before the investigators can develop an intervention in which patients receive tailored     support similar to what occurs with supervised exercise, they need to pilot test the     monitoring aspect of the wearable fitness device in conjunction with the pre-operative     exercise program. The investigators propose a mixed methods, 16 single arm feasibility study     of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable     fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will     identify the strengths, weaknesses, and utility of this approach.   "
9414|NCT03162705|"     This protocol is to obtain tumor tissues and blood samples from patients with a confirmed     histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling.   "
9415|NCT03162692|"     Preoperative anxiety is often described as an uncomfortable, tense unpleasant mood before     surgery, an emotional response to a potential challenge or threat to reality. Data show that     adult patients with preoperative anxiety rate of 30-40%. The main reason for the occurrence     of patients for surgery, anesthesia and other factors of fear. Preoperative anxiety itself is     not a mental illness, but studies have confirmed that the occurrence of preoperative anxiety     and postoperative complications were positively correlated, and the existence of preoperative     anxiety in patients with conventional postoperative analgesic effect is poor. At present,     there are still few studies on the relationship between preoperative anxiety and     postoperative complications and analgesia. At the same time, there is a lack of large sample     size to study the incidence of preoperative anxiety and its related predictors.   "
9454|NCT03162315|"     At the start of the controlled ovarian stimulation as a part of the IVF/ICSI treatment     patients are informed about this trial. In case they gave informed consent and they have a     progesterone level between 1 and 1.5 ng/ml at the day of the hCG injection, they will be     randomised. One group of patients will have a fresh embryo transfer, in the second group all     embryos will be cryopreserved and transfered in a subsequent (natural or artificial) cycle.     The aim of this study is to compare clinical pregnancy rate between the two groups.   "
9416|NCT03162679|"     There is a lack of studies on treatment effect in traumatised refugees. Recent findings     indicate that emotion regulation deficits play a key role in PTSD also among traumatized     refugees and highlight the importance and potential directions for the development of an     emotion regulation training for refugees. In this study, the investigators therefore want to     examine the effectiveness of a new, transdiagnostic, cultural-sensitive group therapy, which     systematically teaches specific emotion regulation strategies. Participants will be randomly     assigned to either the emotion regulation training, delivered in group format or a wait list     control condition. The study takes place in cooperation with REFUGIO Munich, which is a     treatment centre specialised in the treatment of traumatised refugees. Clinicians will     deliver the treatment to traumatized asylum seekers and refugees that report difficulties in     emotion regulation. The investigators will examine if refugees and asylum seekers in the     intervention group will show improvements in psychological symptoms, social functioning as     well as in emotion regulation in comparison to a wait list control group which will receive     the treatment after the intervention group has completed. The group therapy covers 14     sessions and has a cognitive-behavioural background. It focuses on conveying strategies to     cope with intense feelings and the patients should gain a sense of self-efficacy and control     over their trauma-relevant feelings and symptoms. Qualified interpreters will be used in the     assessments as well as group therapies.   "
9417|NCT03162666|"     This study is a post-market clinical follow-up study. The data collected from this study will     serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.   "
9418|NCT03162653|"     Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term     disability in infants born at term in the western world, affecting about 1-4 per 1.000 life     births and consequently about 5-20.000 infants per year in Europe.      Hypothermic treatment became the only established therapy to improve outcome after perinatal     hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected     children die or suffer from long-term neurodevelopmental impairment. Additional     neuroprotective interventions, beside hypothermia, are warranted to further improve their     outcome.      Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and     brain damage in experimental, animal, and early human studies of ischemia and reperfusion.      This project aims to evaluate the efficacy and safety of allopurinol administered immediately     after birth to near-term infants with HIE in addition to hypothermic treatment.   "
9419|NCT03162640|"     Cannabis smokers having begun prematurely their consumption (before 16 years) present a     persistent impulsivity much later after have stopped their consumptions. The literature     highlights that the impulsivity promotes the passage towards a compulsive consumption, and     the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity     would lead the subjects to overestimate the duration of events and to choose immediate     rewards than preferred but delayed rewards. This hypothesis questions the role of the     temporal anticipation in the impulsive choices. In a first hypothesis, the temporal     impulsivity could be an endogenous deficit bound to the reward, and would be responsible for     disorders of the temporal anticipation. In this case, the disorders should be observed     especially when the subject anticipates a reward. Alternately, a disorder of the temporal     anticipation could provoke impulsivity, and in this case, would be present with or without     reward. To separate these hypotheses, we propose to test the capacities of temporal     anticipation of non-smokers and early smokers of cannabis by means of a behavioral task      Hazard function task , which allow to measure the capacity of a subject to anticipate the     apparition of an event on the basis of a temporal cue. The neuronal correlates will be     measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which     reflects the temporal accumulation and the processes of anticipation.   "
9420|NCT03162627|"     This study has 2 phases: Phase 1 (dose escalation) and Phase 2 (dose expansion).      The goal of Phase 1 of this clinical research study is to find the highest tolerable dose     combination of selumetinib and olaparib that can be given to patients who have solid tumors     that are advanced or recurrent (has returned after treatment).      The goal of Phase 2 is to learn if the highest tolerable dose combination found in Phase 1     can help to control advanced or recurrent solid tumors.      The safety of the study drug combination will also be studied in both parts.   "
9421|NCT03162614|"     This study is designed to evaluate efficacy, immunogenicity and safety of various dose     schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and     RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The     purpose of this study is to investigate whether changes in dosing schedule are associated     with increased or equivalent protection, and to evaluate the immune mechanisms associated     with vaccine efficacy under varying dosing schedules.   "
9422|NCT03162601|"     With new developments that have taken place in the optimization of C-arm computed tomography     (CACT) image acquisition and reconstruction, CACT image quality will be better than current     standard-of-care CACT scan techniques used for neurovascular patients referred to     endovascular treatment or diagnosis. As such, novel acquisition, filtration, artifact     reduction and reconstruction techniques will be evaluated against the standard-of-care CACT     approach.   "
9423|NCT03162588|"     In this study, the investigators aim to evaluate the indirect revascularization outcomes of a     new combination therapy of multiple burrhole procedure with promotion of arteriogenesis by     intravenous (IV) erythropoietin (EPO) pretreatment on Moyamoya patients with acute     neurological presentation, and outline the clinical and vascular factors associated with     revascularization through the burrholes.   "
9424|NCT03162575|"     The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy     (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission.   "
33105|NCT02852447|"     The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.      The secondary objective is the analysis of predictors of change in the ovarian reserve after     surgery   "
9425|NCT03162562|"     This is a Phase Ib study to look at the combination of an antibody immunization vaccine     strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol),     both of which have previously been used in combination with other cancer treatments and     demonstrated to be active in advanced cancer, but which have not previously been used     together. This study will assess the approach as to whether these two drugs can safely add to     the response seen with either drug alone, both of which have doses that are based on prior     studies.      Subjects with stable disease for whom a 12 week break from therapy for their persistent and     progressive advanced ovarian cancer is appropriate, who have signed informed consent and for     whom baseline clinical information is completed, will receive 4 cycles of oregovomab/Hiltonol     immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for to look for     a CA125 specific T cell response at 12 weeks before initiating any additional therapy     according to the best clinical judgment of the investigator. At week 16 the subjects will     receive a final dose of the combination of oregovomab/Hiltonol and at week 17 will have an     additional blood draw for analysis of T-cell response.   "
9426|NCT03162549|"     This prospective, non-interventional research registry is designed to study the comparative     effectiveness and comparative safety of approved treatments for IBD in a cohort of patients     cared for by gastroenterologists across North America. Secondary objectives include analyzing     the epidemiology and natural history of the disease, its comorbidities, and current treatment     practices.   "
9427|NCT03162536|"     This Phase 1 dose escalation study will evaluate the safety, pharmacology, and activity of     ARQ 531 in subjects with relapsed or refractory hematologic malignancies dosed orally once     per day beginning at 5 mg/dose for 4 weeks with the following cohorts treating at escalating     doses until a dose limiting toxicity or a recommended Phase 2 dose (RP2D) is reached.     Expanded cohorts studying specific malignancies (e.g., B-cell NHL, WM, CLL) at the RP2D will     be opened to further explore the safety, pharmacology, and activity of ARQ 531 as     monotherapy.   "
9428|NCT03162523|"     There are 3 articles that will be written about the experience with HDR-brachytherapy     (HDR-BT) in patients with high-risk prostate cancer in Norway as part of a doctorial     thesis-project. The project will focus on survival, side-effects and dosimetry variables as     the main points of interest.   "
9429|NCT03162510|"     The primary purpose of the study is to determine the maximal tolerated dose (MTD) of     Oxaliplatin in this phase I study. The secondary objectives are to determine the response     rate, progression free survival, overall survival, and safety profiles.      Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel     (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus     oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till     disease progression.   "
9430|NCT03162497|"     Meibomian gland dysfunction (MGD) is among the leading causes for dry eye syndrome (DES),     affecting millions of people worldwide. We have shown in a previous study that tear film     thickness (TFT) is reduced in patients with DES and that this reduction correlates with tear     break up time (BUT) as well as with the severity of subjective symptoms. Even though systemic     tetracyclines as well as topical azithromycin can be used for the treatment of MGD, it seems     that topical azithromycin is more effective than tetracyclines and also has the advantage of     better tolerability. The hypothesis of the present study is that topical treatment with     azithromycin leads to a more pronounced increase in TFT compared to oral doxycycline in     patients with DES caused by MGD.      The objective of this study is to compare the effect of treatment with topical azithromycin     or oral doxycycline on tear film thickness in patients with DES caused by MGD.   "
9431|NCT03162484|"     Most individuals who have survived an acquired brain injury (ABI) present consequences     affecting the sensorimotor, cognitive, affective or behavioural components. The conditions     can vary from mild to extreme. The consequences of an ABI may have a considerable impact on     their functioning, and secondary conditions like depression or sedentary behaviours, so they     suffer changes in their Health-Related Quality of Life (HRQoL).      The purpose of this project is to determine the effect of a physical activity group program     on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice     physical activity.   "
9432|NCT03162471|"     The aim of the study was to identify whether preoperative corneal astigmatism can influence     corneal biomechanics and the assessment of intraocular pressure (IOP) following     micro-incision phacoemulsification.   "
9433|NCT03162458|"     Purpose of the study:        -  To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute          upper respiratory tract infections.        -  To assess safety of Anaferon for children liquid dosage form in the treatment of acute          upper respiratory tract infections.   "
9434|NCT03162445|"     This is a observational study to investigate the degree to which bone mineral density is     impaired in boys with autism compared with typically developing controls.   "
9435|NCT03162432|"     The goal of this study will be to assess the safety and efficacy of high-dose interval     Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated     with serial Remicade infusions.   "
9436|NCT03162419|"     Study design-Open label randomized controlled trial      Study period-2 years      Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb     2017 to Dec 2018      All the patients of ACLF will receive standard medical therapy and will be randomized within     48 hours of admission into three groups after screening for exclusion and inclusion     criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy +     Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF   "
9437|NCT03162406|"     The subjects participating in the trial will be randomly allocated to either the group     receiving the treatment under investigation (scaling and root planning (SRP) accompanied by     administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction     with placebo) as the control. Random assignment of intervention will be done after subjects     have been assessed for eligibility and recruited, but before the intervention to be studied     begins. After randomization, the two groups of subjects will be followed in exactly the same     way and the only differences between them will be the vitamin D/placebo that they will     receive.   "
12639|NCT03120039|"     To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's     Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility     of accelerometry measurement of UE movement.   "
9439|NCT03162380|"     Bipolar disorder is a mental disorder characterized by alternance of depressive and manic     phases, separated by intercritical phases (euthymia). The majority of patients report     occupation and professional difficulties. Sixty percent of bipolar patients are inactive .     Indeed, according to the World Health Organisation, bipolar disorder is the second cause of     days not worked.      Several factors are related to the lower professional functioning observed in bipolar     patients: early age of onset, delay of diagnosis and treatment, recurrence of thymic     episodes, residual symptoms and cognitive disorders during euthymia, side effects of mood     stabilizers.      To our knowledge, no study has ever focused on well-being at work in French patients.     However, suffering from a psychiatric disorder and the lack of support from colleagues and     the hierarchy are risk factors for burnout, a growing health issue.      Patients with mental illness are often victims of stigmatization, which may involve the     professional field. In addition, thymic recurrences may alter professional functioning of     active patients: multiplication of work disruptions, conflicts with peers. Conversely work     can be stressful, promoting thyic relapses. It is therefore essential to better understand     the occupational stresses of active patients suffering from bipolar disorder in order to     promote functional remission beyond clinical remission.      The aim of this study is to assess the level of stress and well-being at work in active     French bipolar patients.   "
9440|NCT03162367|"     Different medical treatments are available for treatment of skin burns such as skin grafts     and silver sulfadiazine ointment. These treatments are used for second degree burn as routine     technique in burns units. Cell therapy is a new approach for treatment of skin disease.In     this study we use autologous epidermal cell suspension to achieve better cosmetic and     functional results in treatment of second degree burn.   "
9441|NCT03162354|"     To increase the accuracy of doctors' decisions to launch or forgo child abuse evaluations in     their young, acutely head-injured patients, investigators have derived and validated a     clinical decision rule (CDR) that detects abusive head trauma (AHT) with 96% sensitivity in     pediatric intensive care unit (PICU) settings. This CDR Implementation Trial across eight     PICU sites will assess the CDR's actual impact on AHT screening accuracy, identify factors     associated with maximal physician acceptance and application of this novel AHT screening     tool, and assess the sustainability of active CDR implementation strategies.   "
9442|NCT03162341|"     The objective of this research is to evaluate the correlation between DECT and US     explorations performed in a routine clinical setting for the measurement of change in tophus     size in gout patients after 24 months of treatment.   "
9443|NCT03161288|"     This is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study     to evaluate the safety and tolerability of KY1005 in healthy volunteers and volunteers with     mild-to-moderate plaque psoriasis.   "
9444|NCT03161275|"     Subsequent and non-randomised patients, adult patients qualified for major abdominal     surgeries were enrolled   "
9445|NCT03161262|"     The purpose of this study is to determine whether low-cost Short Message Service (SMS)-based     follow-up medication reminders and surveys for surgical site infection (SSI) reporting can     improve outcomes by increasing medication adherence and earlier detection and care of SSI.     This will be a prospective study involving enrollment of patients onto the Memora Health     platform, a web application developed for automating SMS content to patients. Post-operative     patients will be identified by providers and enrolled prior to discharge, after which they     will be followed for 3 months.      Primary endpoints include medication adherence and patient satisfaction with the text     messaging tool. Secondary endpoints include early detection of SSIs, patient satisfaction     with overall post-discharge care and health-related quality of life, and pertinent 30-day     readmissions.   "
9446|NCT03161249|"     The aim of the study is to evaluate the effectiveness of an online intervention through a     mobile application, specifically designed for adolescents with a First Psychotic Episode     (FEP), as a complement to the pharmacological and therapeutic interventions they receive at     their referral center (Treatment as usual). To do this, a longitudinal study will be carried     out on patients with FEP and between the ages of 14 and 19, who come to the Child and     Adolescent Psychiatry Service of the General Universitarian Hospital Gregorio Marañón in     Madrid. Adolescents will be randomly assigned to an experimental group, where they will     receive standard treatment plus online intervention, or a control group, where they will     receive standard treatment.      This online intervention, the continuation of the work of this same team researcher in the     PIENSA program, aims to address little of the more traditional treatments and treatments     such as community functioning, quality of life or affective symptoms. In addition, it will     increase disease awareness, which will lead to greater adherence to treatment and fewer     relapses and rehospitalizations.   "
9447|NCT03161236|"     This graduate student research study has two purposes; the first purpose is to examine the     criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in     healthy middle-aged adults. The second purpose is to examine balance changes using the YBT     following a home-based exercise program.   "
9448|NCT03161223|"     This is an open-label, Phase 1/2a, dose-finding study with an initial phase 1 portion,     articulated in four separate treatment arms, followed by a dedicated phase 2 for qualifying     treatment Arm(s).      The primary objective of the phase 1 portion is to determine the maximum tolerated dose (MTD)     and dose limiting toxicity (DLT) of the combinations of: Durvalumab, pralatrexate, and     romidepsin (Arm A); durvalumab, oral 5-azacitidine, and romidepsin (Arm B); durvalumab and     romidepsin (Arm C); or durvalumab and oral 5-azacitidine (Arm D), in patients with relapsed     or refractory (R/R) peripheral T-cell lymphoma (PTCL). The safety and toxicity profile of     these combinations will be evaluated throughout the entire study.      If one or more of the combinations in Arms A, B, C, or D are found to be feasible and an MTD     is established, the phase 2 portion of the study will be initiated for the combination(s)     with the strongest efficacy signal provided acceptable toxicity.   "
9449|NCT03161210|"     The aim of this study is to compare the treatment effects of dextrose prolotherapy, saline,     and mepivacaine for deactivating myofascial trigger points within the jaw muscles.   "
9450|NCT03161197|"     Kidney Disease subjects will be recruited to take part of a mindfulness-based stress     reduction intervention for 8-10 sessions. All subjects will complete a baseline interview,     one follow-up at 3 months and the close out interview at 5 months.   "
9457|NCT03162276|"     Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a     substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be     detected. The only proven modality for active risk reduction (rather than passive early     detection), is prophylactic surgery - prophylactic mastectomy and oophorectomy. While the     majority of Jewish mutation carriers elect to undergo prophylactic oophorectomy at about age     40 years, in Israel only a minority perform prophylactic mastectomy. Another ramification of     being a mutation carrier is the emotional stress associated with that discovery.Genetic     information has profound implications for mutation carriers. The IBSR (Inquiry-based stress     reduction) intervention, developed by Byron Katie, trains participants to reduce their     perceived level of stress by self-inquiry of their thoughts and beliefs connected to     stressful circumstances or symptoms. This meditative process, named The Work, enables the     participants to identify and question the stressful thoughts that cause their suffering. The     core of IBSR is simply four questions and a turnaround, which is a way of experiencing the     opposite of what the participant believes. This process is simple, powerful and provides     skills for self-inquiry and management of stressful thoughts that can be easily implemented     in daily life [ ]. Therefore, on the basis of previous data and beneficial observations we     postulate that the clinical utility of IBSR mediation program may improve psychological and     physical symptoms and quality of life among asymptomatic (oncologically healthy) BRCA1/ BRCA2     mutation carriers. Thus, we will conduct a pilot randomized controlled trial to     scientifically investigate the effect of this intervention effects on BRCA1/2 mutation     carriers.   "
9458|NCT03162263|"     The use of neurorobotic devices into gait rehabilitative programs, including Ekso, is     reported to increase the engagement and motivation of the patients while actively performing     a task, and to shape the sensory-motor plasticity (SMP) and its balance between the primary     motor areas (M1), and the fronto-parietal network (FPN) connectivity, thus contributing to     successful gait rehabilitation. Aim of our study was to assess whether Ekso would foster the     recovery of deteriorated FPN connectivity and SMP patterns involved in limb coordination     during walking in a sample of patients with hemiparesis due to stroke.      Twenty outpatients were consecutively included in this study according to the following     inclusion criteria: (i) age ≥55 years; (ii) a first-ever ischemic supra-tentorial stroke     (confirmed by MRI scan) at least 6 months before their enrollment; (iii) an unilateral     hemiparesis, with a Muscle Research Council -MCR- score ≤3; (iv) ability to follow verbal     instructions, with a Mini-Mental State Examination (MMSE) >24; (v) a Modified Ashworth Scale     (MAS) score ≤2; (vi) no severe bone or joint disease; and (vii) no history of concomitant     neurodegenerative diseases or brain surgery.      Patients were randomly assigned to the experimental (Ekso gait training -EGT) of control     group (conventional overground gait training -OGT- at a velocity matched to the Ekso gait     training).   "
9459|NCT03162250|"     This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study     to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S     when given in addition to anti-staphylococcal SOC antibiotics to participants with     methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus     aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.   "
9460|NCT03162237|"     The neonatal pig islets will be used as donor culturing with our modified culture medium. At     the same time the autologous T regulatory cells will be used to induce specific immune     tolerance for porcine islets grafts combined the costimulation of T cell activation channel     blockers. The treatment for type 1 diabetes will be evaluated the efficacy and safety.   "
9461|NCT03162224|"     This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and     tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a     HPV DNA vaccine in combination with durvalumab (also known as MEDI4736) which is a human     monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1     and CD80.      An initial six to 12 patients (Safety Analysis patients) will be enrolled and assessed for     safety before additional patients are enrolled.      The initial safety analysis patients along with an approximate total of 50 patients with     human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer     will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in     combination with durvalumab.   "
9462|NCT03162211|"     Depression is a leading cause of burden in Canada and globally. Although more people now seek     and receive treatment for depression, there are still many who do not respond well to     treatments. New and low-cost options are needed to improve the lives of people with     depression. Research suggests that asking patients to complete questionnaires and sending     feedback to their clinicians may improve depressive symptoms. Research also shows that     encouraging individuals with depression to take part in shaping their own care can be     beneficial. To date, no research has examined a combination of these two approaches. This     project aims to investigate the benefits of providing personalized feedback to patients and     clinicians in order to improve the care and outcomes for people with depression in Canada. To     answer this research question, adults who are diagnosed with depression will be placed in one     of two groups: 1. The patient and clinician will receive feedback to help guide further care     based on the patient's responses to questionnaires 2. The patient and clinician will not     receive feedback. The feedback form has been developed with input from clinicians,     researchers and people with lived experience of depression, and follows new Canadian     treatment guidelines. Information including depressive symptoms, quality of life, personal     goals for recovery, and healthcare costs will be collected for a year or longer using an     online data collection platform. The research team includes clinician-scientists, healthcare     managers, educators, primary care physician and people with lived experience of depression.     This project has the potential to deliver significant health benefits for individuals with     depression, lessen the population burden of depression and improve the health care system by     optimizing care delivery and improving quality of life at low cost.   "
9463|NCT03162198|"     All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive     of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver     and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for     inclusion.Based on the previous years data of HCC patients admitted to ILBS.      Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of     arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic     or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the     Study of Liver Disease (AASLD) guidelines (details in appendix1).      Age and gender matched patients with cirrhosis, but without HCC, seen during the same study     period will serve as controls.      Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted.     Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer     (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor     Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.   "
9465|NCT03162172|"     Congenital adrenal hyperplasia (CAH) is a genetic rare disease, which alters the adrenal     production of gluco and mineralo corticoids. The treatment consists in supplementing children     using hydrocortisone. Despite care for these children has improve substantially across     decades, short adult height still remains an important consequence of the disease. About 20 %     of patients have an AH below 2 standard deviations compared to their expected height.      In the OPALE model study, the investigators have collected data from a cohort of 496 French     patients, born between 1970 and 1991 and with a known genotype. Using their age, sex, growth,     disease, bone maturation and pubertal data, they have built a model which allows to predict     their AH using data available at 8 years of age. This model has shown that the currently used     formula to calculate the predicted AH (Bayley Pineau's method) is not applicable to children     with CAH.      In this project, the investigators plan to use the prediction model to compare the AH in     patients who have received GH treatment to their predicted AH using the model.      The hypothesis is that GH improves the AH in such patients. Existing cohorts have shown     improved growth celerity, and growth expectation using the Bayley-Pineau formula), but this     has not been shown on the actual AH.      This study will allow to reinforce the investigators' hypothesis.   "
9466|NCT03162159|"     Congenital Adrenal Hyperplasia (CAH) is a genetic rare disease, which alters the adrenal     production of gluco and mineralo corticoïds. The treatment consists in supplementing children     with hydrocortisone. Despite care for these children has improved substantially across     decades, short adult height (AH) still remains an important consequence of the disease. About     20% of patients have an AH below 2 standard deviations compared to their expected AH.      In the OPALE-Model study, the investigators want to collect data from a cohort of 496 CAH     French patients, born between 1970 and 1991 with a known genotype. Using their age, sex,     growth, disease, bone maturation and pubertal data, the investigators will build a model     which allows to predict their AH using data available at 8 years of age. The growth charts     built from this cohort have shown that currently used formula to calculate the predicted AH     (Bayley-Pineau's formula) is not applicable to children with CAH.      In this project, the investigators plan to compute an AH prediction model using data from     children born between 1970 and 1993, and to validate the model using data from a different     cohort (i.e. children born between 1994 and 1998). this choice was due to availability of     data for computing the model first, and in a second stage, data from more recently born     patients.   "
9467|NCT03162146|"     The individual characteristics and interactions of health care workers in intensive care     units may influence patient safety. This study aims to quantify the influence of team     familiarity among the members of medical and nursing staffs on risk of patient death.   "
9468|NCT03162133|"     A randomized controlled 3-month trial was conducted with two post-treatment assessments of 86     breast cancer survivors receiving Aromatase Inhibitors therapy assigned to either 12 weeks of     90-minute three times per week Baduanjin exercise classes or a wait-list control.     Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated     production of proinﬂammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha     (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD and questionnaires to     measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of     climacteric syndrome were completed at baseline and 3 months.   "
9469|NCT03162120|"     Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence     reaching 5% in patients older than 65 years and an incidence that increases progressively     with age.1 According to the most recent guidelines, class Ic anti-arrhythmic drugs are     considered the first line treatment in patients without significant structural heart disease.     Flecainide is effective in preventing AF recurrences in 31-61% of cases according to     different studies.2-5 A recent study showed that the combination of Flecainide and Metoprolol     improves effective rhythm control in patients with persistent symptomatic AF compared to     Flecainide or Metoprolol alone.6 In contrast, the combination of Flecainide and Metoprolol     conferred no significant benefit over Flecainide alone in patients with paroxysmal AF. This     suggests different underlying mechanisms for paroxysmal and persistent AF. Pulmonary veins     are likely the main focus triggering paroxysmal AF while in persistent AF the role of     pulmonary veins is less important.   "
9470|NCT03162107|"     The goals of this research are to understand adherence and retention in care for multi-and     extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.   "
9471|NCT03162094|"     This is a first-in-human phase I/II randomized, double-blind, placebo (vehicle)-controlled,     multicenter study to assess the Safety and Efficacy of AVX-012 Ophthalmic Solution in     subjects with Mild-to-Moderate Dry Eye Syndrome.      The study consists of two parts (part A and part B):   "
9472|NCT03162081|"     The project focuses on investigating problematic medication use, especially overuse of     potentially addictive drugs among the elderly.      The investigators aim firstly to develop and validate instruments for detecting and     describing behavioral aspects and consequences of dependence on, and misuse of, prescription     medication among elderly.      In addition to evaluating diagnostic utility of screening instruments, the investigators aim     to identify and report characteristics, risk factors and consequences of medication misuse     and dependence among the elderly.   "
9484|NCT03161925|"     In order to make better use of clinical resources of the real world, strengthen the     standardization of PLC diagnosis and treatment, and constantly improve the academic level of     liver cancer in China, we intends to launch Chinese Liver Cancer clinical Survey project in     cancer specialized hospitals and large general hospitals and to explore the best clinical     pathway of PLC multidisciplinary consultation.   "
9485|NCT03161912|"     AURIGA is designed to collect data from routine clinical practice on the effectiveness and     utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic     macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO).      The primary objective of this observational study (OS) is to evaluate the effectiveness of     intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema     secondary to RVO) in each of the participating countries.      Additionally, utilization and treatment regimens in routine clinical practice will be     described.      Health care resources and services as well as health out-comes related to vision loss will be     evaluated based on information collected using the COMETA (Costs and Outcomes of Retinal     Disease) questionnaire.   "
9473|NCT03162068|"     Osteoporosis induced by glucocorticoids excess constitutes the main cause of secondary     osteoporosis. Most of data available are provided from cohort studies of patients treated by     corticosteroids, affecting among 1% of population. In contrast, very few data on osteoporosis     are available in the Cushing syndrome (CS), a rare disease affecting 1 or 2 million of     inhabitants, and characterized by an endogen glucocorticoid excess production. This affection     is responsable of frequent fractures, occuring in 30-60% of patients (vertebral asymptomatic     in 50% of case, hip, ribs). Fractures occurs often frequently above the threshold usually     used for osteoporosis (T-score<-2.5), most often in the range of osteopenia. These data     suggest that surface bone density isn't sufficient to characterize bone fragility,     architectural factors are probably involved, and should be evaluated. The specificity of     osteoporosis induced by endogen glucocorticoids excess in comparison with osteoporosis     induced by estrogenic deficiency in post-menopausal women is poorly known, especially in     endogen glucocorticoid excess.      A recent microarchitecture studies showed alterations of cortical compartment in patients     with Cushing's syndrome, confirming by our preliminary preclinical data from a transgenic     murin model of Cushing's syndrome.      In these ten last years, new radiologic tools have been developped, and are able to evaluate     bone architecture. The peripheral Quantitative Computed analyses the bone architecture with     distinction between cortical and trabecular compartment.      Therefore, we aim to determine the specificity of osteoporosis induced by glucocorticoids     excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.   "
9474|NCT03162055|"     This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24     week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF)     fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to     Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in     Patients with moderate to very severe COPD.   "
9475|NCT03162042|"     The main objective of our study was to determine the modifications of blood myostatin and     activin A concentrations associated with head and neck cancers. Secondary objectives     consisted in studying their influence on the occurrence of cachexia, bringing the proof of a     tumoral secretion of these factors, and then determining the effect of tumor removal.   "
9476|NCT03162029|"     This study will be observational study. The goal of this study is to evaluate the quality of     mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian     patients with chronic renal failure and duration of dialysis using CBCT.   "
9477|NCT03162016|"     Limitation of donor site and significant postoperative morbidity are often described in     connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to     recover miller class I and II recessions defects could be an alternative to connective tissue     graft.   "
9478|NCT03162003|"     The purpose of the trial is to investigate new clinical tests that could predict what     treatments work best for certain patients with advanced prostate cancer by identifying     markers and indicators present in blood and tissue which correlate with treatment response.   "
9479|NCT03161990|"     The functional outcome and quality of life after treatment for an infected hip arthroplasty     have been found to be significantly worse compared to an uncomplicated arthroplasty. However,     the type of revision surgery chosen to treat the infection plays a role for the functional     outcome. The concept of DAIR (debridement, antibiotics and implant retention) has been shown     to yield god results with respect to infection control in cases of early infection with a     stable implant and better functional results than a to-stage revision. In patients where     infection control was achieved after just one DAIR procedure the functional outcome was     comparable to an uncomplicated primary arthroplasty. However, it is not known if the     operative approach used for the primary and revision surgery plays a role for the functional     result after treatment of an infected total hip arthroplasty with DAIR. The project's aim is     to investigate if the choice of the operative approach (transgluteal or posterior) for the     primary hip replacement and the revision surgery has an influence on the functional result     after debridement and implant retention for an infected total hip replacement.   "
9480|NCT03161977|"     This is an observational study designed to research the effect of mannitol on the     concentration of intraoperative serum potassium in patients undergoing craniotomy, and to     guide the safe use of mannitol during craniotomy.   "
9481|NCT03161964|"     Impaired awareness of hypoglycemia is common in type 1 diabetes (T1DM) patients. Impaired     hypoglycemia awareness increases severe hypoglycemia risk by six-fold. Severe hypoglycemia     compromises quality of life and can potentially cause death. The long-term goal of this pilot     study is to lead to the development of novel therapeutic approaches to improve hypoglycemia     awareness and thus prevent severe hypoglycemia development in T1DM population with impaired     awareness of hypoglycemia.      It is hypothesized that propranolol will improve hypoglycemia recognition in T1DM. The     specific aims of the study are to determine whether propranolol treatment improves subjects'     recognition of hypoglycemic episodes, and improves hypoglycemic awareness scores; whether     propranolol favorably increases hypoglycemia blood glucose nadir, decreases     onset-to-treatment/recovery time (i.e. hypoglycemia duration), and reduces     hypoglycemia/severe hypoglycemia frequency; and, whether propranolol reduces fear of     hypoglycemia and improves overall blood glucose control.   "
9482|NCT03161951|"     Method for diagnostics of the origin of infections (bacterial vs viral) based on the     identification of activation markers of blood neutrophils and monocytes will be developed.   "
9483|NCT03161938|"     The aim of this study is to investigate the effect of a single preoperative high-dose steroid     injection on complications in the immediate postoperative phase after periacetabular     osteotomy. Primary outcome is the proportion of patients who have moderate to severe     postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific     complications in the post anaesthesia phase, pain and nausea the first 5 days, wound     infection and readmissions the first 30 days after surgery.      The investigators hypothesize that the frequency of moderate to severe pain and organspecific     complications in the post anaesthesia care unit will be lower among patients receiving high     dose dexamethasone. The investigators hypothesize, that there will be no difference in wound     infections or readmissions.   "
16397|NCT03070847|"     The purpose of this study is to determine whether very low dose of preoperative tranexamic     acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction     in patients undergoing elective rhinoplasty surgery.   "
9486|NCT03161899|"     Thalassemia is a blood disorder passed down through families in which the body makes an     abnormal form of hemoglobin. There are 2 main types of thalassemia; Alpha & Beta thalassemia.     Alpha thalassemia: occurs when a gene or genes related to the alpha globin protein are     missing or mutated.      Beta-thalassemia syndromes are a group of hereditary blood disorders characterized by reduced     or absent beta globin chain synthesis. Beta-thalassemias can be classified into:      Silent carrier: completely asymptomatic with normal hematological parameters.     Beta-thalassaemia minor (beta-thalassaemia trait): usually asymptomatic; diagnosis is made     during a work-up for mild anemia.      Beta-thalassaemia intermedia: usually a similar presentation to beta-thalassaemia major;     symptoms are usually less pronounced and the course is usually more insidious.      Beta-thalassaemia major : In which there is complete absence of hemoglobin A   "
9487|NCT03161886|"     This study aims to demonstrate that CCE is effective for monitoring DR and MH of the entire     GI tract and in directing therapy for pediatric patients with CD.   "
9488|NCT03161873|"     In this study physiological data is measured using wearable sensors as well as hormonal and     ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically     healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were     recruited to generate reliable data on changes of the measured physiological parameters in a     healthy menstrual cycle, as well as to evaluate physiological changes associated with early     pregnancy.      All pregnancies beginning during the study period are to be monitored to their natural end,     in order to evaluate how the same nine physiological parameters are changing during     pregnancy, how strong the variations of the parameters during pregnancy are, and whether they     could be associated with early onsets of pregnancy complications such as premature birth or     pre-eclampsia. This will be highly valuable to develop study protocols for the specific     evaluation of the screening potential of pregnancy complications.   "
9489|NCT03161860|"     Global aging and the growing burden of chronic diseases represent a challenge. Innovative     interventions acting upon health determinants, like social participation, are required.     Social participation, defined as the involvement of a person in activities that provide     interactions with others in the community is critical to promote health and prevent     disabilities. Many older adults do not have equitable opportunities to achieve full social     participation, and interventions under-empower their personal and environmental resources and     only reach a minority. To optimize current practices, the Personalised citizen assistance for     social participation (APIC), an intervention demonstrated as being feasible and having     positive impacts, needs further evaluation.      The first aim of this study is evaluate the impacts of the APIC on older adults' health,     social participation, life satisfaction and healthcare services utilisation. The second aim     is to evaluate the cost-effectiveness of the intervention. In parallel, the implementation of     the APIC, including factors facilitating and impeding it, will be documented.      Concerning the first two objectives, two hypotheses are formulated: 1) the APIC will prevent     a decline in older women's and men's health, social participation and life satisfaction, and     reduce their use of healthcare services, and 2) the APIC will be associated with lower costs,     from older adults', healthcare system and societal perspectives, including healthcare     expenditures.   "
9490|NCT03161847|"     The objective of this study is to test a set of clinical outcome measures longitudinally in a     cohort of OPMD patients to identify ones that show quantifiable change over time as the     disease progresses. The investigators' goal is to delineate the natural history of OPMD.   "
9491|NCT03161834|"     The purpose of this study is to evaluate whether increased mutant ESR1 allele fraction in     plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of     progression free survival in patients with ER+ metastatic breast cancer.   "
9492|NCT03161821|"     The purpose of this study is to identify circulating tumor cells in patients with solid     tumors. Quantify and characterize these cells, collect patient information in regards to the     patient's cancer. Develop a database and a sample repository where future analysis could be     done.   "
9493|NCT03161808|"     This is a non-interventional, multi-site, specimen collection study for CF patients who have     rare CFTR mutations.   "
9494|NCT03161795|"     PURPOSE: Assess the risks of long-term opioid therapy, particularly the elements that     influence aberrant behavior in chronic non-cancer pain patients.      Pain, particularly chronic pain, is a major threat to the quality of life worldwide and will     become more so as the average age increases. Currently, over 30% of the world's population is     known to have chronic pain. Opioid agonists are effective medicines for the treatment of     moderate and severe pain, however, opioid consumption remains below the requirements in most     countries. In 2010, the WHO measured the ratio of opioid consumption using the Adequacy of     Consumption Measure (ACM) and found that 66% of the world population has a level of Virtually     No Consumption of opioids (ACM < 3%). Conversely, in countries with ACM > 100% such as the     United States of America (USA), drug overdose deaths (the majority involving an opioid) have     nearly quadrupled since 1999. Therefore, long-term use of opioids for chronic noncancer pain     patients remains controversial owing to concerns regarding analgesic tolerance and drug     dependence. Additionally, to date research consists of very low-quality evidence and studies     on long-term opioid use have not been conducted. Particularly, in Korea no studies about     opioid use rates in chronic non-cancer pain patients, opioid misuse or chemical coping     statistics, neither opioid therapy guidelines for long-term opioid use are available.     Therefore, the investigators will conduct a retrospective EMR (Electronic Medical Record)     review of patients with chronic non-cancer pain receiving long-term opioid therapy, combined     with a prospective study using surveys to determine the rate of opioid aberrant behavior by     using the diagnosis of chemical coping. Based on the factors that influence chemical coping     and by testing available risk tools, the development of an effective predictive screening     instrument is anticipated. Additionally, a prompt assessment of opioid misuse will be     feasible by such screening instrument. The results of this study will help to design     guidelines for the use of long-term opioid therapy that reflects the needs of countries with     inadequate ACM. Moreover, Korea's rates of opioid use and chemical coping in chronic     non-cancer pain patients will be determined, and lastly, adequate levels of opioid analgesics     consumption that balance the benefits and risks of long-term opioid use will be promoted,     contributing to a safer and more effective pain treatment.   "
9495|NCT03161782|"     The aim of the study is to compare the efficacy of Proprioceptive Neuromuscular Facilitation     (PNF) stretching and static stretching on range of motion (ROM), pain and function in elbow     limitation.   "
9496|NCT03161769|"     Investigate the ability of the intra-operative, intra-aneurysmal flow evaluation to assist     with the treatment of intracranial large aneurysms using Embolization Device(s)   "
9509|NCT03161600|"     This study will explore provider's screening and management practices for eligibility for     neoadjuvant therapy from baseline to following the project intervention (use of a novel     existing technology, the Carevive Care Planning System at the point of care plus provider     continuing medical education.   "
9863|NCT03157011|"     the investigators propose to carry out a prospective study consisting of a systematic     research of digestive symptoms in patients with SGSp with the validated Global symptom score     (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild,     moderate, or severe), asthenia and fever.   "
9497|NCT03161756|"     The purpose of this project is to test the addition of a new treatment called denosumab to     standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for     many years to help treat cancers such as prostate cancer and breast cancer, but it is not     currently used in melanoma. We hope the addition of denosumab to current melanoma therapies     will make these treatments work better without adding to the side effects.      Who is it for? You may be eligible to join this study if you are aged 18 years or over and     have been diagnosed with metastatic melanoma (melanoma that has spread).      Study details: Nivolumab and ipilimumab are approved treatments for advanced melanoma in     Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study,     are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as     standard care. However, there is limited information on the effectiveness and safety of these     treatments in combination with denosumab. Recent melanoma research in animal models has shown     that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because     denosumab has been used in patients with breast and prostate cancer for a long time and is     safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in     this study.   "
9498|NCT03161743|"     This is a study to determine 1) the consistency of platelet-rich plasma produced by several     methods, and 2) whether the platelet content of platelet-rich plasma can be accurately     estimated from a baseline CBC platelet count.   "
9499|NCT03161730|"     The purpose of this study is to compare the intubation time and success rate between     videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh     laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice     airway managers.   "
9500|NCT03161717|"     Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups     will be defined based on the method used to identify the epidural space for epidural     anesthesia: the loss of resistance group (n=20) and the epidural electrical stimulation group     (n=20). Pain will be assessed using a numerical visual analog scale and maternal satisfaction     by a post-partum interview. The success rate of epidural analgesia, maternal satisfaction,     and neonatal Apgar scores will be compared between groups.   "
9501|NCT03161704|"     This study involves the prospective collection of endometrial biopsy tissue, serum, plasma,     whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not     having) endometriosis at the time of scheduled surgery. The investigators plan to enroll     approximately 500 women to validate and optimize the use of genomic classifiers alone or in     combination with serum markers (such as cytokines) as a non-surgical marker of disease.   "
9502|NCT03161691|"     Single-center, single-arm pilot study to evaluate the ability of C-arm computed tomography     imaging to assess perfusion parameters, collateral vessels, recanalization and brain ischemia     in patients with suspected or proven ischemic stroke or brain ischemia in the     neuro-angiography suite.   "
9503|NCT03161678|"     The purpose of this investigation is to evaluate when genetic variation in the     carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex     vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor.     We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel     platelet aggregation while having a minimal effect in ticagrelor-treated subjects.      Specific Aim: To conduct a prospective randomized crossover study of clopidogrel and     ticagrelor in healthy individuals stratified by CES1 genotype. Participants will be recruited     by CES1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and     ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet     aggregometry performed pre- and post-drug administration in order to assess the interaction     of genotype and drug choice on on-treatment platelet function.   "
9504|NCT03161665|"     Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow     transplantation (BMT), is a potentially life-saving therapy for many malignant and     non-malignant conditions. Despite advances over the past decade, which have led to improved     outcomes, BMT remains an intense treatment modality often requiring prolonged     inpatient--based care. While many patients endure the acute complications of the procedure,     it is common for BMT patients and their caregivers to experience increased risk of financial     and emotional burden, hospital readmission, and health service utilization. This highlights     the importance of active involvement of BMT patients in their own health care     (self--efficacy).      Given the intense nature of BMT, however, caregivers also play a critical role in the process     and are a necessary component of proceeding with transplant. As such, caregiver activation on     behalf of the patient plays a critical role in effective patient--caregiver-provider     partnerships, which is increasingly recognized as the optimal model for health care delivery,     particularly for those facing life--altering medical treatments. It is essential to develop     effective strategies to enhance this partnership. Health information technology (IT)-mediated     tools offer the potential to overcome constraints in health care delivery limited by provider     time, complicated health information, and financial pressures. Significant gaps in knowledge     exist on the use of health IT tools using low- cost and well- accepted delivery platforms in     routine inpatient care, especially for high- risk or critically ill populations. We     hypothesize that a tablet--based tool displaying personal health information could provide a     platform to promote caregiver activation and enhance health communication.   "
9505|NCT03161652|"     This is a randomized, double-blind, placebo-controlled trial to evaluate the safety and     efficacy of levosulpiride to improve retinal alterations due to diabetic macular edema and     diabetic retinopathy   "
9506|NCT03161639|"     Verify, through a randomized double-blinded clinical trial, the influence in the performance     of pulpectomies in primary teeth, based on two working length methods, electronic and     radiographic.   "
9507|NCT03161626|"     This is a non-interventional, multicenter, post-marketing registry study in three patients     with moderate or severe hereditary FX deficiency, to assess Coagadex administered     peri-operatively for hemostatic cover in major surgery during routine post-marketing use.   "
9508|NCT03161613|"     This is a post-marketing study of patients who started nivolumab as first- or second-line     therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small     cell lung cancer (SqNSCLC) , metastatic non-SqNSCLC, metastatic renal cell carcimona (RCC),     or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN), or     third-line therapy for classical Hodgkin lymphoma (cHL) in Mexico.   "
9510|NCT03161587|"     Chronic obstructive pulmonary disease (COPD) is a complex disease characterized by multiple     clinical manifestations as well as co-morbidities. While COPD subjects have traditionally     been classified based solely on airflow limitation (forced expiratory volume in one second     [FEV1]), a new classification system was introduced in the year of 2011 by the Global     Initiative for Chronic Obstructive Lung Disease (GOLD) that recommended subjects with COPD     should be classified based on a combination of airflow limitation, disease impact (determined     by symptom burden and activity limitation) and history of exacerbation. This approach results     in the classification of subjects in four groups: A (low risk, less symptoms), B (low risk,     more symptoms), C (high risk, less symptoms), and D (high risk, more symptoms). This     classification system was further refined in year 2013, specifically around the history of     exacerbation definition, where having ≥1 exacerbation leading to hospital admission in     preceding year was added as a criteria for classification into the high risk C or D groups.     Further, in the year 2016, there was a refinement of the disease impact criteria that suggest     the use of the COPD Assessment Test (CAT) score (over the Modified British Medical Research     Council Dyspnea Scale [mMRC] score) as the preferred tool to determine classification as     more symptoms or less symptoms. This study aims to understand subject characteristics and     current treatment modalities in different groups classified by GOLD 2016 comprehensive     classification system and to understand if current treatment choice is concordant with the     GOLD recommendations in real life clinical practice in China tertiary hospitals. It will     provide a useful point-in-time description of COPD subject characteristics and current     treatment modalities in real life clinical practice in China.   "
9511|NCT03161574|"     Neoadjuvant 5-Fu based chemoradiation followed by surgery is a standard treatment for locally     advanced rectal cancer. However, radiation-related side effects could not be neglected. But     this multimodality strategy failed to improve survival. Neoadjuvant chemotherapy alone may be     an alternative strategy to minimize treatment-related toxicities without compromising the     oncology outcome. Thus, patients with MRI-defined CRM-positive rectal cancer will receive 6     cycles of neoadjuvant treatment with FOLFOXIRI followed by surgery. The purpose of the study     is to evaluate the efficacy of FOLFOXIRI alone as neoadjuvant treatment in treating patients     with locally advanced rectal cancer.   "
9512|NCT03161561|"     COPD is a leading cause of lung disease and a common cause of hospitalisation, time off work     and death. Smoking is the major factor associated with development of COPD. Nevertheless why     some people develop COPD while others, including many smokers do not, is poorly understood. A     central feature of COPD is accumulation of a particular type of white blood cell, the     neutrophil, which is a key component in defence against bacterial infection in the lung     airway. As disease progresses the small airways of many patients with COPD start to     accumulate bacteria, which are normally lacking in the small airways of healthy individuals     or smokers who lack COPD. The accumulation of bacteria in the smaller airways of many     patients with COPD may be important to the development of the disease. Researchers will test     if blood cells, which normally ingest and kill bacteria, have a reduced ability to perform     this function in patients with COPD and whether the clearance of these blood cells after they     have performed their role in protecting against infection is impaired. Researchers will     relate these findings to the clinical features of COPD in a well-defined group of patients     who have had extensive characterisation of their disease. In particular, researchers will     relate this defect to the presence of frequent flares of disease, which lead to symptoms of     wheezing and shortness of breath. Comparison will be made between blood cells obtained from     the lung and from he blood to determine if the alterations are specific to the lung.     Researchers will identify particular molecular alterations in the way these blood cells     respond to bacteria and determine whether they can correct these alterations using agents,     which are used to treat a range of different medical conditions, but which they predict might     correct these alterations in function. The aim of this programme of work is ultimately to     identify new ways in which to treat COPD and the agents, which the researchers demonstrate     have the greatest potential to correct the abnormalities in cell function of patients with     COPD, would in the future be studied in clinical trials.   "
9513|NCT03161548|"     This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety     of tongue conservation treatment with sequential induction chemotherapy, tongue conservation     surgery and postoperative concurrent chemoradiotherapy (CCRT) in patients with advanced oral     tongue cancer.   "
9514|NCT03161535|"     This study will investigate the effectiveness of a rehabilitation program in improving sleep     quality, emotional distress, circadian rhythms, and quality of life in patients with     esophageal cancer in Taiwan.      Hypothesis:        1. The quality of life in exercise group is significant improving than usual-care group at          3rd, 6th, 12th, 24th, and 36th month.        2. The quality of sleep in exercise group is significant improving than usual-care group at          3rd, 6th, 12th, 24th, and 36th month.        3. The emotional distress in exercise group is significant improving than usual-care group          at 3rd, 6th, 12th, 24th, and 36th month.        4. The circadian rhythms in exercise group is significant improving than usual-care group          at 3rd, 6th, 12th, 24th, and 36th month.   "
9515|NCT03161522|"     The goal of this clinical research study is to learn if adding additional chemotherapy and     radiation, either with or without surgery, can help to control esophageal or gastric cancer     with oligometastases in patients whose disease did not get worse after receiving at least 6     cycles of chemotherapy as part of their standard care.      Oligometastases means there are less than 3 places in the body where the disease has spread.   "
9516|NCT03161509|"     Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will     measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after     sleeve gastrectomy.   "
9517|NCT03161496|"     It is general that there are many factors for individual differences of drugs in clinical     application, of which genetic factors accounted for more than 20%. Novel oral     anticoagulants-NOACs (include rivaroxaban, apixaban, dabigatran and so on) have advantages of     convenient use and no need of monitoring, compared with the traditional vitamin K antagonist.     With lack of predicted biomarkers, especially the research data of Chinese, it has the     important significance in studying individual differences of NOACs in the anticoagulant     efficacy and safety, through the pharmacogenomics research.      The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug     transporters and drug target genes in Chinese population. By detecting the gene polymorphism,     we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG)     correlation of NOACs and provide scientific basis for accurate medication guide for people to     use NOACs.   "
9518|NCT03161483|"     The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study     to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in     adult subjects with active systemic lupus erythematosus.      Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to     receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.   "
9550|NCT03160924|"     Over the past two decades, fast track surgery, also known as enhanced recovery after surgery     (ERAS) has been initiated and developed in colorectal surgery by Kehlet. The program is     rapidly gaining popularity due to the significant benefits demonstrated in lowering     complication rates and reducing hospital stay and costs. The benefits demonstrated in     colorectal surgery by randomized trials and meta-analyses reduced pain, morbidity and     hospital stay. Data in gastrectomy however, is scarce. Therefore the aim of this study is to     compare the outcomes of laparoscopic gastrectomies with two different perioperative     approaches, the traditional and the ERAS approach in a setting of a randomised controlled     trial.   "
9519|NCT03161470|"     Benign paroxysmal positional vertigo (BPPV) is the most common inner ear cause of dizziness.     It has been reported that up to 900 of every 10,000 people in the United States experience     this problem with an estimated annual healthcare cost approaching $2 Billion. This problem     occurs when calcium carbonate crystals which are present and needed in one part of the     balance area of the inner ear become displaced to a different part of the balance area. This     is very disruptive to the function of the inner ear and results primarily in intense vertigo.     Nausea,imbalance, and falls can also occur. The accepted course of management for BPPV is the     use of repositioning maneuvers which are completed by moving patients through specific     head/body positions that literally reposition the displaced crystals out of the wrong area.     These treatment methods are reported to be effective for about 80% of patients after     one-to-three treatments. For the remaining 20% of patients, more treatments may be necessary     and for a small percentage of patients surgical options may be the only cure. Additionally,     some patients with BPPV are not able to physically move into the needed positions because of     hip and neck problems, spinal problems, obesity, other mobility limitations, etc. Within the     past decade, a motorized chair was developed to help reposition any patient with BPPV. There     have been no reported adverse incidents with the motorized chair but the device was quite     expensive so it was only available at a handful of clinical sites. At this time the motorized     chair is no longer being manufactured. More recently, a mechanical chair was developed and     has been in use in Europe and China. The mechanical chair has all the advantages of the     motorized chair but with a lesser cost. The inventor of the mechanical chair has also     developed some slight variations on treatment technique that may have the potential to     improve treatment efficacy. We are privileged to have the only mechanical chair of this type     in the United States. The primary purpose of the current project is to systematically     investigate the treatment efficacy of this mechanical chair for patients with BPPV. We will     compare treatment outcomes for patients diagnosed with BPPV using standard methods, the     mechanical chair, and a sham condition also using the mechanical chair. A secondary purpose     is to determine treatment efficacy for patients with covert BPPV. We will simply measure if     treatment with the mechanical chair has any effect on patient symptoms. If we determine     treatment is improved with the mechanical chair then it may be possible to help a greater     number of patients with BPPV with fewer treatments.   "
9520|NCT03161457|"     This is a multicentre, randomised, double-blind, parallel group study to compare the     pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, safety, tolerability and     efficacy of JHL1101 versus MabThera in subjects with moderate to severe RA who have     previously failed at least 1 tumour necrosis factor alpha (TNF) inhibitor (i.e., intolerance     or documented active disease despite at least 12 weeks treatment according to the TNF     inhibitor-approved treatment and dosage), and are on concomitant treatment with MTX.   "
9521|NCT03161444|"     This study will estimate the cumulative incidence of Zika infection at the end of the first     epidemic in the French West Indies in a sample of patients followed for HIV infection.   "
9522|NCT03161431|"     Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune     responses from destroying the cancer. This study will be the first study to begin to     determine if the newly discovered drug SX-682 can block cancers from attracting MDSCs. This     first study will enroll participants with melanoma, as melanoma cancer has been shown to be     able to attract MDSCs. The study will begin to determine if SX-682 is a safe and effective     treatment of melanoma. It is thought that SX-682 will block MDSCs from going to the cancer,     and thus will allow a patient's own immune system to attack the cancer.      The first participants enrolled in the study will receive for 21 days SX-682 as monotherapy.     After 21 days participants will receive pembrolizumab therapy (an approved immunotherapy for     melanoma) and will remain in the study for evaluations for 3 months.      After these participants complete the monotherapy stage, the next participants will receive     SX-682 and pembrolizumab together as combination therapy. These participants will receive the     combination therapy and be evaluated in the study for approximately 2 years.   "
9523|NCT03161418|"     The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a     topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial     growth factor receptor 2 (HER2).   "
9524|NCT03161405|"     The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4     inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.   "
9525|NCT03161392|"     Mammograms performed at the Diagnostic Imaging Department of the Instituto Brasileiro de     Controle do Câncer (IBCC - Brazilian Cancer Control Institute) will be prospectively     evaluated. Patients who present a solitary dilated duct visualized by mammography will be     submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy     will be performed.   "
9526|NCT03161379|"     The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along     with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab     combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.   "
9527|NCT03161366|"     Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate     additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola     virus disease.   "
9528|NCT03161353|"     The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and     pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their     predictive value for pathologic complete response (pCR) in the breast and axilla.      And also assess 3-year invasive disease-free survival (iDFS) in patients with HER2-positive     (HER: human epidermal receptor) breast cancer treated with neoadjuvant trastuzumab and     pertuzumab (± endocrine therapy) using a FDG-PET response-adapted strategy.   "
9529|NCT03161340|"     Infertility and miscarriage ordinary events in reproductive failure in humans, as are     affected one couple in every six couples of reproductive age and abortion is including in     approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted     Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains     below 30% and Recurrent Implantation Failure in one of the most important limiting factor is     the assisted reproductive techniques. According to studies conducted in recent years one of     the most important mechanisms of implantation failure is maternal immune system because the     fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that     ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly     associated with implantation failure. It also increases the number of natural killer (NK)     cells and Th17 cells and their cytokines in peripheral blood of mother and is also associated     with an increased risk of infertility. Several studies have also shown that the fertile     persons in compare to infertile have increased amount of Treg cells and inhibitory cytokines     associated with it. The studies have shown that if patients are properly selected RIF and     placed under appropriate immunotherapy approaches it will be seen a significant increase in     fertility. Among the factors affecting the performance of the immune system, small non-coding     MicroRNA (miRNA) noted that the RNA of 19-22 nucleotides in length. MicroRNAs act by     inhibiting expression of target genes can be linked to pregnancy and implantation process.     Hence micro RNAs can be used as biomarkers for the detection, predicting pregnancy and even     infertility treatment. Studies have shown that micro-RNAs in the endometrium are in dynamic     changes during the menstrual cycle, reproductive system and implantation and diseases such as     endometriosis, frequent miscarriage. MicroRNA-1229, miR-133b and miR-223 was proposed to     select and review their changes before and after treatment with Rapamycin. Rapamycin is a     macrolide fungus was identified about 40 years ago. Biochemical studies on primates led to     the identification of molecules mammilian target of rapamycin (mToR) is the target molecule     for Rapamycin. MToR molecules play a fundamental role in the regulation of cell metabolism,     cell proliferation and mammalian cell response to environmental conditions and play a role in     the process of cell growth and cell proliferation. While mTOR Complex 2 (mTORC2) play role in     the survival and migration of cells. Rapamycin inhibits T lymphocyte proliferation through     inhibit mToRc1 function. In this study, after we selected patients with RIF, according to     immunologic disorders are treated with Rapamycin, a drug suppress the immune system is then     put the result of treatment with immunological parameters as well as we have evaluated     possible effects in success of the implantation and response to treatment.   "
9530|NCT03161327|"     Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden,     currently estimated to be greater than cancer and heart disease. Older age (> 65 years),     smoking, diabetes and kidney diseases are some risk factors associated with PAD and are known     to have increased morbidity and mortality.Early detection is critical for mitigating PAD     progression. Ankle-brachial index (ABI) testing is recommended by the US Preventative     Services Task Force as an affordable and effective screening tool for evaluating PAD risk.      QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital     device that is used as a screening tool to measure ABI of patients at risk of PAD. This     single center prospective clinical trial will evaluate the sensitivity and specificity of     digital ABI in detecting PAD using color Doppler ultrasound and 'gold standard' angiography     as reference. Specifically in patient undergoing dialysis and who cannot undergo ABI using     pressure cuffs dialysis grafts/ fistulae in the arms, we will evaluate the value of digital     ABI in detecting PAD.   "
9531|NCT03161314|"     Plantar heel pain (PHP) or plantar fasciitis is one of the major foot problems which can     occur in any age group. It is a common encountered musculoskeletal problem that can cause     disability, activity limitation, discomfort, and affect quality of life. It involves pain and     inflammation of the plantar fascia, which runs across bottom of the foot and connects heel     bone to toes. PHP frequently found in active workers aged between 25 and 65 years with the     highest incidence in people aged between 40 and 60 years.      However, very few studies investigated the alterations of the multisegmental foot motions and     muscle functions in patients with PHP. To prescribe the relevant program of treatment and     reduce risk of symptoms chronicity, it is necessary to have in-depth understanding of     changing mechanisms in patients with PHP. To explain how the symptoms occur in patients with     PHP, foot function is another aspect that should be determined. One of the popular     questionnaires determining foot function is the Foot Function Index (FFI) questionnaire. It     has been proved to have a good reliability and validity and has been translated into several     languages. To be able to use the international standard questionnaire, it is necessary to     translate the FFI into Thai. This can be implemented in Thailand and be able to compare the     findings of interventional effect internationally. In addition, very few studies reported the     effectiveness of the treatment program for patients with PHP. Among previous evidences, the     controversial findings existed. Thus, the intervention program should be evaluated for     obtaining the effective treatment for this population.   "
9532|NCT03161301|"     This study will provide mechanistic insight into the underlying causes and molecular level     pathogenesis of periodontal diseases. We will identify key mechanisms that confer risk and     protection. Ultimately this will lead to new and improved diagnostics and therapeutics.     Because periodontal disease is a uniquely accessible biofilm-associated disease it will     provide insight into many other diseases such as inflammatory bowel disease and chronic     infections associated with indwelling catheters and artificial prostheses. Subjects with     periodontal conditions will have therapeutic benefit from the treatments provided.   "
9533|NCT03161145|"     A medical review chart study in Japan to describe the treatment patterns and outcomes of     patients with kidney cancer that is unable to be removed by surgery or that has spread. The     clinical data is to be abstracted using electronic data capture (eDC) from patient medical     records in Japan.   "
9534|NCT03161132|"     Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of     progression-free survival at 6 months in patients with platinum resistant advanced ovarian     cancer.   "
9535|NCT03161119|"     Numerous published trials now document that the embryo transfer (ET) procedure has a huge     impact on pregnancy and delivery rates after IVF (In Vitro Fertilization).      To compare the ease of use (defined as the rate of successful atraumatic insertion) of     different types of embryo transfer (ET) catheters.      This prospective randomized unblinded controlled clinical trial is performed to determine if     there is any difference in ease of use among 2 different catheters : Cook k-soft-5000, Cook     K-JETS-551910-S.      Inclusion criteria: patients < / = 38 years of age, body mass index (BMI) between 18 and 28,     at least one frozen-thawed blastocyst transferred.      Exclusion criteria: ICSI (Intracytoplasmic Sperm Injection)-TESE (Testicular Sperm     Extraction) IVF cycles.      A number of 352 consecutive women undergoing embryo transfer will be selected for this     prospective, randomized controlled trial. Two protocols for endometrial preparation will be     used before frozen/thawed blastocyst transfer: the modified spontaneous protocol and the     oral/transdermal preparation protocol. ET will be done with patient in lithotomy position,     under ultrasound guidance. No anesthesia will be used for the procedure.      176 patients will be enrolled in this trial and randomized to enter one of the two catheter     group.   "
9536|NCT03161106|"     The study will be conducted on patients attending /admitted to Department of Hepatology from     April 2017 to December 2018 at ILBS, New Delhi .      Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors     and supervisor. Patients in treatment group will receive nutritional therapy in the form of     30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet     that they were receiving before along with lactulose. Previous treatment and prophylaxis of     variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as     before. All subjects will be followed up every month for treatment compliance and for     development of any complications.   "
9537|NCT03161093|"     The primary objective of the study is to evaluate the efficacy of fasinumab compared with     placebo, when administered for up to 16 weeks in patients with osteoarthritis (OA) of the     knee or hip.      The secondary objectives of the study are:        1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up          to 16 weeks in patients with OA of the knee or hip        2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to          52 weeks in patients with OA of the knee or hip        3. To assess the safety and tolerability of fasinumab compared with naproxen, when          administered for up to 16 weeks in patients with OA of the knee or hip        4. To assess the safety and tolerability of fasinumab compared with naproxen, when          administered for up to 52 weeks in patients with OA of the knee or hip        5. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients for          up to 52 weeks        6. To evaluate the immunogenicity of fasinumab administered to patients for up to 52 weeks   "
9864|NCT03156998|"     An observational study to investigate the compliance of home nebulizer therapy among children     aged 0-14 years old clinically diagnosed with asthma   "
9538|NCT03161080|"     The prevalence and incidence of dry eye syndrome (DES) is constantly increasing. Several     therapeutic strategies have been proposed, but still no ideal regimen has been found.     Recently, a new method for the non- invasive measurement of tear film thickness (TFT) based     on optical coherence tomography (OCT) has been developed. It has been shown in previous     studies that TFT correlates well with objective signs as well as with subjective symptoms of     DES.      In the present study the effects of three different topical lubricants (Neovis total multi®,     Vismed multi® and Hydrabak® eye drops) on tear film thickness in patients with moderate to     severe DES will be investigated using this device.      Tear film thickness will be measured at baseline and at defined time points after single     instillation. The course of tear film thickness during this study day will provide     information about the corneal residency time of the three different eye drops. Patients with     moderate to severe DES will be randomized to receive either Neovis total multi®, Vismed     multi® or Hydrabak® eye drops. Assessment of lipid layer thickness of the tear film will be     performed before and at pre-specified time points after instillation as secondary outcome.      Other clinical measures for DES such as determination of tear film break up time (TFBUT),     corneal fluorescein staining, Schirmer I test and subjective assessments will also be     performed.   "
9539|NCT03161067|"     The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort     Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient     Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96     Programmable Stimulator. The goals of this early feasibility study consist of safety and     efficacy evaluations of this device.   "
9540|NCT03161054|"     This is a phase II study of metronomic chemotherapy in elderly non-fit patients (>65 years)     with aggressive B-Cell lymphomas   "
9541|NCT03161041|"     Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit     from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However,     even after optimal cytoreduction, systemic and locoregional recurrence are common.     Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients.     The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with     colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study     evaluates whether perioperative chemotherapy including BEV in combination with CRS and     oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite     endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity,     pathological response, progression free survival, and overall survival.   "
9542|NCT03161028|"     The purpose of the study is to determine if lipoic acid can preserve mobility and protect the     brain in progressive forms of multiple sclerosis.   "
9543|NCT03161015|"     A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral     dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment     disease and healthy subjects with normal renal function.   "
9544|NCT03161002|"     It is general that there are many factors for individual differences of drugs in clinical     application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type     receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism.     With lack of predicted biomarkers, especially the research data of Chinese, it has the     important significance in studying individual differences of ticagrelor in the antiplatelet     efficacy and safety, through the pharmacogenomics research.      The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug     transporters and drug target genes in Chinese population. By detecting the gene polymorphism,     we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG)     correlation of ticagrelor and provide scientific basis for accurate medication guide for     people to use ticagrelor.   "
9545|NCT03160989|"     The study will evaluate the variability of blood pressure in postmenopausal and hypertensive     women after only one session and after training of ten weeks of combined physical exercises     (aerobic and resisted).   "
9546|NCT03160976|"     The aim of this study is to analyze the effects of a single session of cryolipolysis on     localized adiposity on women's abdomen. This is a randomized controlled clinical trial that     will include 28 women who will be randomly allocated into two groups: Control Group or     Intervention Group. The following assessments will be performed in both groups:     ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization     and blood analysis at baseline and 15 and 30 days after randomization. The expected main     result at the end of this study is the reduction of the local subcutaneous fat tissue.   "
9547|NCT03160963|"     We will determine when to transition from the common vertical jump to chair stand depending     on age and physical activity levels.   "
9548|NCT03160950|"     A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated     using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these     crowns will be assessed for anatomical form, marginal adaptation, color match, marginal     discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and     modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th,     12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th     and 60th month).      A total of 50 patients will be selected and one tooth per subject will be included. For the     purpose of study only the healthy adult patients with age range of 25 - 60 years who would be     requiring Single crown restoration in the permanent anterior / posterior teeth, either due to     caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic     treatment shall be included in the study only after successful endodontic therapy has been     completed by an experienced endodontist. For broken teeth, only the teeth with > 1/2 crown     structure remaining or in case of teeth with <1/2 crown structure fractured that can be     restored with conventional post and core will be selected. In general, patients with bruxism,     or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.   "
9549|NCT03160937|"     The purpose of this study was to assess the acute effects of a single NM treatment session on     DOMS and to compare them with those of one foam roller (FR) session. Following the damaging     plyometric exercise bout, the participants were randomly assigned in a counter-balanced     fashion to either a FR or NM treatment group; treatments were administered 48-h     post-exercise. The dependent variables were recorded before the exercise, 48-h post-exercise     before treatment, and immediately post-treatment.   "
9551|NCT03160911|"     Non-variceal acute gastrointestinal bleeding is a common and potentially life-threatening     problem. The conventional treatment of this condition is for esophagogastroduodenoscopy (OGD)     for haemostasis. Treatment methods include heater probe, clipping and injection of     adrenaline. Recently, a new device called the Over-the-scope clip (OTSC) has been device to     treat perforations and bleeding in the gastrointestinal tract. Therefore, the aim of the     study is to compare between the treatment outcomes between OTSC and conventional endoscopic     haemostatic methods in ulcers that are of high risk for rebleeding.   "
9552|NCT03160898|"     The purpose of this study is to assess the effect of CK-2127107 versus placebo on respiratory     function and other measures of skeletal muscle function in patients with ALS.   "
9553|NCT03160885|"     Primary objective:      To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe     AD.      Secondary objectives:      To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health     related quality of life compared with placebo.      Maintenance objective:      To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared     to placebo for subjects achieving clinical response at Week 16.   "
9554|NCT03160872|"     To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral     follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in     non-infertile women.   "
9555|NCT03160859|"     This is a study to compare two different, but normally, used methods of colonoscopy in     patients undergoing colonoscopy without sedation. There will be two arms in this study: WE     (water exchange) control, and WE (water exchange) plus cap (placed at tip of the     colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal     instructions and he/she will be given the information for the study at that time so that     he/she can make a decision to participate in the study. The control method will use water     instead of air during insertion of the colonoscope. The study method will use a cap that will     fit onto the end of the colonoscope plus water during insertion of the colonoscope. This     study will assess if the study method is less painful than the control method.   "
9556|NCT03160846|"     The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal,     observational study designed to look at the demographics and outcomes of heart failure     patients on inotropic therapy administered in the home or infusion suite setting. The data     gathered in this registry will provide information on how a patient's quality of life and     symptoms change over time while on inotrope therapy, and help healthcare providers to have a     better understanding of the benefits and risks associated with bridge-to-treatment and     palliative care.   "
9557|NCT03160833|"     This is a dose escalation study consisting of two stages: Dose-escalation stage (stage 1):     Patients will take a single dose of HMPL-453 on Day 1 and will be followed for one week for     safety observations. After one week of observation, if no safety issues occur, patients can     continue multiple dosing of HMPL-453 QD (quaque die) and start on the DLT (Dose Limited     Toxicity) assessment cycles. Each cycle consists of 28-days. Patients are required to draw     blood samples for PK and safety analysis at specific time points during the treatment;     Dose-Expansion Stage (Stage 2): This stage is to further evaluate the safety, tolerability,     PD (pharmacodynamics) profile, and preliminary anti-tumor activity of HMPL-453 at the RP2D     (recommended phase 2 dose) in approximately 10 patients with advanced solid tumor.   "
9558|NCT03160820|"     This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in     subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to     4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18     month-old subjects with one dose immunization with measles-rubella(MR).   "
9559|NCT03160807|"     Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI   "
9560|NCT03160794|"     In the clinical scenario of recurrent prostate cancer (PCa) post local therapy, current     standard studies (bone scan and computed tomography) commonly fail to identify the recurrent     disease location. In this study the investigator aims to prospectively map recurrent disease     with the unique combination of whole-body MR anatomical imaging combined with a new     high-sensitivity and PCa-specific PET probe (PSMA-targeted: [18F]DCFPyL) to provide precise     localization information to target disseminated tumor deposits in men presenting with rising     PSA after prostatectomy and radiotherapy (maximal local therapies). Moreover, we will     consequently treat all identified disease with image-guided stereotactic ablative     radiotherapy (SABR), which has shown tantalizing results achieving excellent tumor     eradication rates with minimal toxicities. This study is uniquely positioned to enable the     discovery of new biomarkers and the correlation of prognostic tests (e.g. genomic signatures)     from the initial prostatectomy specimen with the PET/MR imaging results and SABR treatment     outcomes.      The significance of the proposed work towards a measurable impact in PCa care is important to     emphasize. The study team believes this novel curative-intent approach will transform lives,     as opposed to therapies that transiently impact incurable disease stages. Herein, the focus     is on patients at the earliest point of the disease spectrum of recurrent PCa after     curative-intent treatments. Our hypothesis is that PSMA-targeted [18F]DCFPyL PET/MR allows     earlier detection and localization of defined metastatic targets in these patients, at a     stage amenable to image-guided curative-intent therapy.   "
9561|NCT03160781|"     The aim of this study was to assess a novel approach to treating severe knee osteoarthritis     by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and     subchondral bone by combining intra-articular injections and intraosseous infiltrations of     platelet rich plasma.This study explored a new strategy consisting of intraosseous     infiltrations of platelet rich plasma into the subchondral bone in combination with the     conventional intra-articular injection in order to tackle several knee joint tissues     simultaneously.   "
9635|NCT03159819|"     A single arm, open-label pilot study is designed to determine the safety, tolerability and     engraftment of CAR-CLD18 T cells in patients with advanced gastric adenocarcinoma and     pancreatic adenocarcinoma.   "
9636|NCT03159806|"     Patients will be invited to participate from an outpatient nephrology clinic at Hammersmith     Hospital. They will have a microdialysis catheter inserted into a peripheral vein and     connected to a sampling system. The samples will be sent for analysis in the hospital     laboratory. All medical devices to be used are already CE-marked and approved for these     purposes.   "
9562|NCT03160768|"     Expression of the cell cycle regulator p16INK4a increases with age and toxic stressors. In     mice, both radiation and chemotherapy are known to increase p16. Due to its influence on     age-related regenerative capacity, p16 is an excellent candidate biomarker of physiologic     reserve that may identify patients able to withstand the stressor of chemotherapy (low p16)     from those unlikely to tolerate chemotherapy (high p16). That is, expression of p16 may     predict physiologic, rather than chronologic, age. Such findings could have implications for     care of cancer survivors and treatment decision-making in cancer patients.      STUDY OBJECTIVE: This is an observational pilot study to determine the feasibility of     isolating p16INK4a in CD3+ T lymphocytes in adults treated with chemotherapy for cancer     during childhood.   "
9563|NCT03160755|"     Specific Aim #1: To identify, through qualitative research, deficits in positive emotional     states (e.g., positive affect, optimism) and associated barriers to completing health     behaviors, like physical activity and healthy eating, in patients with metabolic syndrome     (MetS).      Hypothesis: Participants will be able to complete semi-structured interviews, providing     information about their positive emotional states, linking the presence of positive emotions     to better adherence to health-related behaviors, and identifying additional barriers (e.g.,     logistic, motivational) to completing such behaviors.   "
9564|NCT03160742|"     The goal of this research study is to determine the feasibility and accuracy of Mespere Life     Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system)     in children with congenital heart disease (CHD).   "
9565|NCT03160729|"     The aim of this study is to investigate the effect of a single preoperative high-dose steroid     injection on complications in the immediate postoperative phase after open kidney surgery     (kidney resection, heminephrectomy, nephrectomy). Primary outcome is complications in the     post anaesthesia care unit (PACU). Secondary outcomes are organspecific complications in the     post anaesthesia phase, pain and nausea the first 5 days, seroma and wound infection the     first 14 days and readmissions the first 30 days after surgery.      The investigators hypothesize that the frequency of transfer to the PACU and organspecific     complications will be lower among patients receiving high dose dexamethasone. The     investigators hypothesize, that there will be no difference in wound infections, seroma or     readmissions.   "
9566|NCT03160716|"     This is a multi-center, open-label, single-arm study to evaluate an injection tool with     Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface     contour deficiencies.   "
9567|NCT03160703|"     The purpose of this study is to evaluate and compare the stain build up of two stannous     fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels,     with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice.   "
9568|NCT03160690|"     Prospective and observational study to determine if choroidal thickness increases after non     penetrating deep sclerectomy in patients with open angle glaucoma   "
9570|NCT03160664|"     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and     its safety for bipolar mania. Half of the participants will receive MST, while the other half     will receive electroconvulsive therapy (ECT).   "
9571|NCT03160651|"     Approximately 50% of patients admitted for severe AH will have spontaneous improvement of     liver function before initiation of therapy (ie decrease in mDF between hospital admission     and initiation of steroids). These patients have a better prognosis than patients without     spontaneous improvement of liver function. It has never been demonstrated that     corticosteroids improve survival in severe AH patients with spontaneous improvement of liver     function. Our hypothesis is that severe AH patients with spontaneous improvement of liver     function represent a group who could most benefit from steroids   "
9572|NCT03160638|"     Rationale:      Treatment in tuberculosis (TB) is focused on eradication of the bacterial infection, however,     after treatment approximately half of patients are left with a significant and permanent     respiratory impairment. Adjunctive host-directed therapies are being investigated to modulate     host immune responses to target mycobacterium tuberculosis (Mtb) infection and/or reduce     excessive inflammation, prevent pathological tissue damage, preserve lung function and     enhance effectiveness of standard drug therapy, while nonetheless eliminating Mtb. Macrolide     antibiotics have previously been used in the treatment of multidrug-resistant TB. In addition     to their antibiotic effects, macrolides have also been recognized to induce anti-inflammatory     and immunomodulatory effects in other lung diseases.      Objective:      To investigate the immunomodulatory effects of azithromycin in tuberculosis patients     receiving standard therapy (isoniazid, rifampicin, pyrazinamide, ethambutol (HRZE))      Study design:      A prospective, randomized open label intervention trial to investigate the immunomodulatory     effects of azithromycin      Study population: 24      Intervention: azithromycin 250 mg once daily or standard of care (control)      Main study parameters/endpoints:        1. To assess whether azithromycin enhances resolution of systemic inflammation in patients          with drug susceptible pulmonary TB receiving standard treatment.        2. To assess whether azithromycin on top of standard treatment in patients with drug          susceptible pulmonary TB reduces airway inflammation and reduces tissue degradation and          remodeling        3. To investigate whether these effects are associated within shortening of the time to          sputum conversion.   "
9573|NCT03160625|"     RESPOND-HF is a prospective, multi-center, non-significant risk pilot study with cross-over     design. The purpose of the study is to investigate if rate adaptive pacing has the potential     to provide benefit to HF patients with preserved ejection fraction, referred to as HFpEF     patients. Findings from this pilot study may be used to guide subsequent efforts to design     and conduct a prospective, randomized, multi-center pivotal trial powered to show improvement     in patient outcomes.   "
9574|NCT03160612|"     The objective of this research study is to 1) evaluate the effectiveness of web based     transfer training materials for wheelchair users and 2) determine the reliability of a     refined transfer assessment instrument (TAI) as completed by individuals who use wheelchairs     for a majority of mobility and clinicians who score transfers in-person and remotely.   "
9826|NCT03157492|"     This study evaluates the benefits of short-term training via telehealth for post-lingually     deafened adult cochlear implant users. Half the participants will receive aural     rehabilitation and the other half cognitive training. The hypothesis is that short-term aural     rehabilitation via telerehab technology will improve outcomes for post-lingually deafened     cochlear implant users   "
9575|NCT03160599|"     Malignant gliomas are the most common type of brain tumor. Standard therapy for glioblastoma     multiforme (GBM) includes surgery followed by radiation and chemotherapy. Despite optimal     treatment the prognosis remains poor. There is an urgent need for more effective therapies.     The Warburg effect has been widely observed in human cancers. The main energy supply of tumor     cells are aerobic glycolysis. Therefore, they are highly dependent on glucose metabolism.     Recently, some scholars have suggested that 'Restricted calorie Ketogenic Diet (RKD)' might     be able to inhibit glycolysis and thus anti-tumor by restricting carbohydrate intake. This     will 'starve' cancer cells, which will lead to cell death. There are many animal and in vitro     studies shown that RKD can reduce the tumor size and thus tumor cell growth of malignant     glioma in mice. However, a consistent positive result can not be found within a small sample     of clinical trials. In this study, 50 patients with malignant glioma will be treated with or     without RKD. The safety and efficacy of RKD and the patients' tolerance will be observed in     order to understand whether this therapy can be a potential new treatment of malignant glioma     in the brain. This clinical study is comparatively large internationally. It is the first     domestically. If it is successful, it can be applied to other areas of tumor. This study is     essential to extend the survival of patients with malignant glioma, and to study clinical     nutrition support and its metabolic pathways for malignant tumor.   "
9576|NCT03160586|"     Stuttering was defined as a common neurodevelopmental speech disorder characterized by     repetitions, prolongations, and interruptions in the flow of speech. In other words,     stuttering is a speech disorder characterized by involuntary disruptions to speech which     impede the capacity to communicate effectively.      Physiological and emotional anxiety has been reported in persons who stutter. It has been     reported that as high as 44% of clients seeking treatment for stuttering could be assigned a     co-occurring social phobia or social anxiety diagnosis.   "
9577|NCT03160573|"     The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in     human subjects in controlling oral malodor in partial fulfillment of the requirements for     recognition by the American Dental Association's (ADA) requirement for obtaining ADA Seal for     malodor.   "
9578|NCT03160560|"     The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in     human subjects in controlling oral malodor in partial fulfillment of the requirements for     American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.   "
9579|NCT03160547|"     This trial will investigate the effects of higher protein dosing (>/=2.3 g/kg/d) vs lower     protein dosing (</=1.3 g/kg/d) on clinical outcomes in critically ill patients.   "
9580|NCT03160534|"     This study evaluates the effect of preoperative exercise in patients undergoing a total knee     arthroplasty.   "
9581|NCT03160521|"     This is a multicenter, randomized, double-blind, placebo-controlled study designed to     evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or     100 mg) or placebo, in patients with acute exacerbation of schizophrenia.   "
9582|NCT03160508|"     This study documents real life weight bearing in patients treated with a TFNA, who are     allowed for immediate weight bearing as tolerated.   "
9583|NCT03160495|"     The purpose of this study is to investigate if heterogeneity in head and neck squamous cell     carcinoma as seen in functional imaging with PET/MR can be correlated to biologic     heterogeneity in surgical specimens.   "
9584|NCT03160482|"     Nowadays, the investigation of thyroid nodules is limited by the fact that up to 49% of the     fine needle aspirations (FNA) performed on them are of indeterminate cytological     signification. Moreover, no reliable molecular marker for thyroid cancer have been developed     up to this day. The goal of this project is to study the expression of a specific kind of     protein convertase in benign and in malignant thyroid nodules to determine its potential as a     clinically useful biomarker.   "
9585|NCT03160469|"     a prospective intragastric elipse balloon effect on weight loss for certain BMI. this study     also proposed to assess the safety of the elipse balloon   "
9586|NCT03160456|"     The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of     the pharyngeal dilator muscles in patients with obstructive sleep apnoea in the community     compared to usual care, and follow the patients for 3 months, as well as to assess compliance     of non-invasive electrical stimulation of the upper airway dilator muscles in obstructive     sleep apnoea patients over time and evaluate the control of symptoms and improvement in     quality of life.   "
9587|NCT03160443|"     Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial     model, but pathophysiology remains relatively unknown, and robust etiological models to guide     treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability     factors have been found in eating disorders including decision making abnormalities. The     investigators hypothesize that decision making abnormalities are associated with a lower     level of functioning and quality of life which could lead to social and interpersonal     difficulties. The investigators also hypothesize that these anomalies are associated with a     particular clinical profile (more restrictive profile, more hyperactivity, less insight on     the disease and desire for care ...).   "
9588|NCT03160430|"     This is a multi-center, two-part study; Part A and Part B. Part A of the study is an     open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and     non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive     hemodialysis as standard of care.      Part B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD     patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a     daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with     SoC.      The primary objective of the study is to evaluate if treatment with RVX000222 in combination     with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo     and SoC.   "
9589|NCT03160417|"     The aim of the study is to describe CBF modifications during rewarming after targeted     temperature management in cardiac arrest patients   "
9723|NCT03158675|"     Vitiligo is an acquired disease with a variable course. It is characterized clinically by     well-defined depigmented macules or patches thought to occur secondary to melanocyte     dysfunction and loss. it is the most common depigmentation disorder, affecting approximately     0.5 to 2.0 percent of the population and has no predilection for gender or race .   "
9590|NCT03160404|"     Introduction: The prevalence of chronic insomnia in the general population is 10 to 15%. The     therapy commonly prescribed for its treatment is pharmacological, however, there are several     non-pharmacological therapies being studied, among them physical exercise. Although some     studies have described the effect of exercise on the promotion of sleep in insomnia, no     studies comparing exercise and drugs in the treatment of insomnia, or its effect as     coadjuvant therapy, have been performed.      Objective: To compare the effects of regular aerobic exercise (12 weeks) with pharmacological     therapy (zolpidem, 10mg / night) or combined therapy (exercise + pharmacological therapy) on     sleep quality, mood and quality of life of patients with chronic insomnia.      Material and Methods: 45 patients with chronic insomnia will be randomly assigned to three     groups: aerobic exercise (GEA), pharmacological therapy (GTF) and combined therapy (GTC). The     GEA group will participate in an aerobic exercise program for 12 weeks, performed in     intensity relative to 50% of reserve heart rate, on a treadmill. The GTF group will be     treated with zolpidem 10mg / night and the GTC will be treated with zolpidem 10mg / night and     will participate in the aerobic exercise program. For sleep evaluation will be used the     polysomnography, actigraphy, sleep diary and questionnaires. Mood and quality of life will be     investigated through questionnaires.      Hypothesis: Considering previous studies have demonstrated positive effects of aerobic     exercise in the insomnia symptoms, the hypothesis of this study is aerobic exercise,     performed at moderate intensity, can control the symptoms of chronic insomnia similar to     pharmacological therapy, and when combined with it, can accentuate its effects, also     contributing to improvements in patients' mood and quality of life.   "
9591|NCT03160391|"     The study used a randomized controlled trial to test the efficacy of two interventions (dance     and musical training) for typically developing children. Interventions were run for three     weeks in local community locations. Participants were tested before and after the     intervention on a battery of cognitive and behavioural measures. They were compared across     groups, and to a control group who do not receive the intervention.      The purpose of the current study was to assess the influence of dance and musical training on     cognitive development. Research has indicated that musical training is associated with     improve cognitive functioning, although the direction of such an association is unclear.     Further, it is uncertain whether any benefits are specific to musical training or can also be     demonstrated with other training activities. The current study used a randomized controlled     trial to assess the causal effects of dance and musical training.   "
9592|NCT03160378|"     The purpose of this trial is to investigate the effect of organizational skills training, a     parent and child training approach on organizational skills, inattentive symptoms and     functional outcome in children age 6-13 years. Half of the participants will receive     treatment as usual (TAU) and organizational skills training and the other half will receive     TAU.   "
9593|NCT03160365|"     A key feature of low-dose brachytherapy is that irradiation affects only a local area around     the inserted radiation sources. The exposure of healthy tissues around these sources is then     reduced. However, the number of adverse events remains high (about 79% of patients with     sexual problems and 30% of patients with urinary incontinence) and brachytherapy is no better     than other treatment options for Preservation of the urethral apparatus (about 40% of     patients).      The current technique for the implantation of radioactive sources, which has not been revised     since the early 1980s, consists in imaging the prostate at the beginning of the     intraoperative procedure with transrectal ultrasound in order to evaluate the size and shape     of the prostate . This information is then used to identify the best distribution of the dose     of radiation to be administered to each patient. This treatment planning step is based on a     procedure where the operator manually places 50 to 100 grains of iodine in the prostate.     These grains are inserted transperinally under transrectal 2D ultrasound control, using     needles through a transperineal grid with several needle guides evenly spaced 5 mm apart.     This is an arduous task because this manual grain placement procedure must take into account     the dose to be administered to the prostate without exceeding the dose limit for the     surrounding organs at risk (rectum, urethra). In addition, the overestimation of the dose     formality called TG-43 and the inaccurate grain placement can contribute to the creation of     cold spots where no dose is administered. It may be responsible for recurrences of prostate     cancer after brachytherapy treatment. Although brachytherapy dosimetry has been extensively     researched, the TG-43 dose formalism has been the benchmark for the last 20 years. Moreover,     from an economic point of view, the high side-effects rates of the treatment of prostate     cancer result in particularly expensive post-treatment costs. The search for improved     solutions for the treatment of prostate cancer remains a major societal challenge.      In recent years, a very attractive therapeutic alternative between active surveillance and     overall treatment is gaining popularity among experts: focal therapy.      It is a localized treatment, limited to cancerous areas, in order to preserve healthy     functional tissues inside and outside the organ and thus the quality of life of the patient.      Focal therapy is also often the preferred solution for recovery therapy (second     intervention).      Finally, focal therapy has great potential to reduce the cost and duration of the     intervention, as well as the cost of follow-up.      In recent years, several energies have been proposed as being adapted to focal therapy, such     as high intensity focal ultrasound, laser ablation and cryotherapy. Brachytherapy, which     already gives above average results in the treatment of whole glands, has been identified as     a very good candidate for this new therapeutic paradigm.      In brachytherapy, radioactive grains are implanted in the prostate using transperineal     catheters. The rapid reduction of the dose according to the distance of the radioactive seeds     gives the physician a great flexibility to control the radiation accurately. It allows     intermediate approaches between global and focal treatments, providing great scalability, and     it is a good candidate for recovery therapy.      Recent studies have shown that focal brachytherapy allows more than half of the needles and     seeds to act more strongly on the target while irradiating Significantly less The urethra and     rectum. Clinical studies on this subject are still limited and further research is needed to     confirm the performance of this approach.   "
9594|NCT03160352|"     The aim is to assess the effects of virtual reality-based intervention on vestibular     functions in healthy community dwellers.   "
9595|NCT03160339|"     PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral) is an     investigational vaccine in development for the indication of active immunization against     adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety,     pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.   "
9596|NCT03160326|"     Currently there is no standard way to detect age-related skeletal muscle loss in patients     with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways     to measure muscle size and fat within the muscle.   "
9597|NCT03160313|"     This study will evaluate feasibility and preliminary effectiveness of a 10-week     interdisciplinary and multimodal intervention that utilizes patient education, group     discussion, and supervised exercise for Veterans with a history of traumatic brain injury     (TBI). Primary outcomes include physical activity (PA), sleep quality, and community     integration.   "
9598|NCT03160300|"     This study evaluates the effect of binaural beats on pain perception and subsequent need for     analgesic medication use in patients suffering from diseases causing chronic pain. All     patients will receive two consecutive interventions: binaural beat signals embedded in     relaxing music and placebo (relaxing music without the binaural beat component), in random     order.   "
9599|NCT03160287|"     More than 50% of older persons with osteoarthritis (OA) experience disrupted sleep and     insomnia symptoms of difficulty falling asleep, awakening during the night, and awakening too     early and being unable to fall back to sleep. Because OA pain has been implicated in sleep     problems and because physical exercise interventions have been found to improve pain and     sleep quality, staying physically active during the daytime is likely advantageous in terms     of improving sleep. Physical exercise interventions with a duration between 10 and 16 weeks     have been shown to improve quality of sleep in older adults with self-reported disrupted     sleep. Unfortunately, recent reports show that older adults with OA are mainly sedentary and     few meet national guidelines for recommended amounts of daily physical activity. A     self-management intervention that integrates use of mobile technology to prompt older adults     to be physically active, provides ongoing monitoring of the amount of their physical activity     and includes self-efficacy enhancements is a novel non-pharmacological intervention both for     prevention and treatment of sleep deficiency in persons with OA.      The proposed study will involve delivery of automatic physical activity-focused text     messages, a novel sleep self-management diary (SleepTight) and motivational interviewing in     participants with OA of the hip or knee (most commonly affected joints). The purpose of this     Project is to pilot test a new self-management program: MobMPATI, a multidimensional,     tailored intervention for sleep deficiency in for older adults with OA. The specific aims are     to:        1. Test the acceptability of MobMPATI for older adults with OA and poor sleep quality as a          manifestation of sleep deficiency.        2. Test the feasibility of implementing MobMPATI for older adults with OA, as well as          collecting electronic data from the sample.        3. Explore pre/posttest changes in self-efficacy, motivation and sleep deficiency measures          [total sleep time (TST) and sleep efficiency (SE)] with the MobMPATI intervention.      This study will provide feasibility/acceptability and preliminary data necessary for a larger     clinical trial of MobMPATI intervention to encourage physical activity and reduce sedentary     behavior in older adults with OA as a way of reducing sleep deficiency. Preliminary testing     of the intervention will indicate what measures are more sensitive in promoting self-efficacy     and motivation so that a smaller number of outcomes could be monitored to reduce participant     burden. This study is the first step in this innovative program of research. The knowledge     gained will provide data on the benefit of a potentially cost-effective intervention that     could be implemented on a large scale to improve health of older adults with OA.   "
9600|NCT03160274|"     Pheochromocytomas and paragangliomas are neural crest-derived tumors of the nervous system     that are often inherited and genetically heterogeneous. Genetic screening is recommended for     patients and their relatives, and can guide clinical decisions. However, a mutation is not     found in all cases. The aims of this proposal are to: 1) to map gene(s) involved in     pheochromocytoma, and 2) identify genotype-phenotype correlations in patients with     pheochromocytoma/paraganglioma of various genetic origins.   "
9601|NCT03160261|"     The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg)     exenatide given subcutaneosly (s/c) on cortisol secretion. Secondary outcomes involve ACTH     and glucose levels.   "
9602|NCT03160248|"     This is an investigator-initiated, single-center, prospective, randomized, double-blind,     interventional phase IIb study. Forty patients with clinically and histologically confirmed     nummular eczema will be enrolled according to inclusion and exclusion criteria. Patients will     be included after written informed consent is obtained. Prior to randomization, average     application rate of class II topical steroids per day will be measured for 4 weeks.     Subsequently, patients will be randomized in a 1:1 ratio into one arm to receive Apremilast     30 mg BID (following titration phase) for 16 weeks or a second arm receiving identically     matching placebo for 16 weeks. From beginning of week 17, all patients will start an     open-label treatment with Apremilast 30 mg BID until week 32. Concomitant use of topical     steroids (class II) is allowed during the study. During the treatment period both placebo and     Apremilast will be applied p.o. from week 0 until week 32.   "
9603|NCT03160235|"     Studies that will be carried out on healthy volunteers will have as main objective the     development and optimization of the parameters of sequences or the design of the paradigms of     stimulation in order to optimize the quality and the relevance of the images realized taking     in Taking account of anatomical, functional or metabolic parameters, or integrating new     approaches resulting from technical evolutions   "
9604|NCT03160222|"     The prospective study will include 200 patients and 50 critically ill patients, who had an     abdominal computed tomography (CT) scan including the L3 level for any clinical reason.     Ultrasound scans of the anterior thighs and forearms will be taken after the CT scan within     48 hours. Bioelectrical impedance analysis (BIA) will also be performed. In addition muscle     strength, mobility, physical function and nutrition will be assessed. Primary outcome is the     prediction of CT-based whole body muscle and fat volume and BIA-based fat and lean body mass     from ultrasound-based muscle and fat thickness. Other secondary outcomes include the intra-     and interrater reliability of the CT evaluation and ultrasound examination of muscle and fat     mass. The relationship between clinical aspects (strength, mobility, physical function,     nutrition) and whole body composition is another secondary outcome.   "
9605|NCT03160209|"     The primary purpose of this single-center, case-control, non-interventional study is to     determine risk factors which contribute to the development of esophageal squamous cell     carcinoma (ESCC) at Kamuzu Central Hospital (KCH) in Malawi.   "
9606|NCT03160196|"     To assess the efficacy of an electronic system to support clinical decisions based on an     evidence-based clinical practice guide for metabolic control of adults with Type 2 Diabetes     Mellitus through Clinical and cluster-randomized controlled trial in a Colombian population.   "
9607|NCT03160183|"     The purpose of this study is to identify important associations between complete and     comprehensive clinical, laboratory, and genomic data derived from patients and tumor     specimens, with prospectively recorded clinical outcomes. The investigators also hope to move     beyond simple risk factor associations as previously described, to develop a composite score     specifically for KS recurrence or progression, analogous to widely used risk scores that are     used to direct up-front treatment of other cancers. In so doing, the investigators will draw     on extremely granular data to prospectively identify patients who are most likely to benefit     from new treatments.   "
9608|NCT03160170|"     This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue      Elevator & Retractor [SISTER] device to assess:        -  Effects on operative time and efficiency of exposure in open lumbar spine cases.        -  Effect on total blood loss during the exposure part of the operation.        -  Rate of clogging of suction device.   "
9609|NCT03160157|"     This research is being done to examine which minimally invasive surgical approach is     associated with the best outcomes when performing cholecystectomy surgery: laparoscopic or     robotic?      Laparoscopic and robotic approaches are similar surgical procedures using small incisions.     The laparoscopic approach is largely used for the removal of the gallbladder     (cholecystectomy).      At UIC, the investigators perform the majority of the gallbladder surgeries through the     robotic approach and only a few using the laparoscopic approach. The robotic surgical tools     allows the surgeon the same freedom of movement as a human wrist, while using a 3D camera     view.      The laparoscopic and robotic surgical approaches both represent minimally invasive surgery     approach and are associated with less pain, faster recovery and better cosmetic outcomes when     compared to traditional open surgery. It is not currently known which approach is better.   "
9610|NCT03160144|"     Postoperative Pulmonary Complications (PPC) are very common. It severely affects     postoperative recovery, particularly in the abdominal surgery. Patients with laparoscopic     resection of colorectal cancer generally have a higher age and decreased lung function     reserve. At the same time, they prone to developing atelectasis due to the effects of     pneumoperitoneum pressure. Therefore, they are a high-risk group of respiratory insufficiency     and PPC.      Mechanical ventilation with a low tidal volume is a routine in clinic nowadays. However, this     conventional strategy will also result in atelectasis formation. Therefore, it may     deteriorate the vulnerable lung function of patients undergoing laparoscopic resection of     colorectal cancer. Patients with Acute Lung Injury or Acute Respiratory Distress Syndrome     (ALI/ARDS) could benefit from the open lung approach, including the use of positive     end-expiratory pressure (PEEP) and recruitment maneuvers (RMs). Whether a lung protective     mechanical ventilation strategy with medium levels of PEEP and repeated RMs, the open lung     approach, protects against respiratory insufficiency and PPC during laparoscopic resection     of colorectal cancer is uncertain. The present study aims at comparing the effects of open     lung approach mechanical ventilation strategy and conventional mechanical ventilation     strategy in PPC, extra-pulmonary complications, length of hospital stay, biomarkers of lung     injury and changes of respiratory function in patients undergoing general anesthesia for     laparoscopic resection of colorectal cancer.   "
9637|NCT03159793|"     A huge number of children suffer from anxiety during their dental treatment especially those     who did not receive any type of behavior management during their first dental visit. This     will result in a more complicated treatment sessions for the children, dentist and the     parents. Fear and anxiety control is the key to change the resistant nature of the anxious     patients and also allow them to receive the proper treatment they require. From the point of     view that there is no difference between the techniques effectiveness, evaluation of two     modelling techniques (live modelling and filmed modelling versus no modelling) for children     anxious behavior management during the dental treatment will be performed.   "
9611|NCT03160131|"     In Denmark, about 120,000 people suffer from brain damage, of whom approx. 75,000 with brain     damage after stroke. Serious and often lasting vision impairments affect 20% to 35% of people     after stroke. Vision is the most important sense in humans, and even smaller permanent     injuries can drastically reduce quality of life.      Vision impairments after brain damage inhibits rehabilitation and enhances other invalidating     effects. Reduced vision results in impaired balance, increased risk of serious falls,     increased support needs, reduced quality of life, and impaired ability to perform activities     of daily living. Restoration of visual field impairments occur only to a small extent during     the first month after brain damage, and therefore the time window for spontaneous     improvements is very limited. Hence, brain-impaired persons with visual impairment will most     likely experience chronically impaired vision already 4 weeks after brain injury and the need     for visual compensatory rehabilitation is substantial.      Neuro Vision Technology (NVT) is an supervised training course where people with visual     impairments are trained in compensatory techniques using special equipment. Through the NVT     process, the individual's vision problems are carefully investigated and personal data is     used to organize individual training sessions that practice the individual in coping with     situations that cause problems in everyday life.      The purpose of this study is to investigate whether rehabilitation with NVT can cause     significant and lasting improvement in functional capacity in persons with chronic visual     impairments after brain injury. Improving eyesight is expected to increase both physical and     mental functioning, thus improving the quality of life. Participants included in the project     will be investigated in terms of both visual and mental functions, including quality of life,     cognition and depression. Such an investigation has not been performed previously and can     have a significant impact on vision rehabilitation both nationally and internationally.   "
9612|NCT03160118|"     This clinical fase IV study, using the administration of a single dose of a quadrivalent,     inactivated, split influenza virus vaccine as biological intervention will mirror a study     conducted at Imperial College, London, UK that will use a challenge with live virus as     intervention. Comparison of the clinical observations and laboratory measurements generated     in both studies will inform us about the similarities and differences in innate and adaptive     immune responses elicited by both types of exposure to influenza virus antigen(s).   "
9613|NCT03160105|"     The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be     simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological     suppression is achieved. Using a factorial design, the study aims to assess the efficacy of     DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as     well as the costs of a patient-centered ART laboratory monitoring.   "
9614|NCT03160092|"     Young people with At Risk Mental State (ARMS) may have changes in their thoughts and the way     they see or hear things, which they might find odd and distressing. They may be feeling     tense, worried and low in mood and may not feel like socialising. They may also experience     difficulties with eating and sleeping. For many people these symptoms might not last for very     long, but for a small number of people, they might last longer and could become worse (health     professionals call this psychosis).      Psychological therapy, which involves talking to a therapist, can help to stop these symptoms     from getting worse, stopping psychosis. It can also help to make the symptoms better.     Cognitive Behavioural Therapy (CBT) is the treatment that is most recommended to help young     people with ARMS. But, this is not always available, can take a long time and is quite     expensive. Some research has shown that brief therapy with a therapist who is warm and     understanding and helps the young person to make sense of their symptoms, may be as helpful     as CBT, and is quicker and cheaper.      This study hopes to develop a treatment like this and to offer it to 12 young people, aged     between 16 and 25, who are experiencing the symptoms outlined. Participants will be given     four treatment sessions, and will be asked to complete some questionnaires. The study aims to     see how they find it and whether it seems to help them. It will also ask professionals who     work with these young people what they think about the new therapy. This is a feasibility     study so the findings will help us to decide whether more research should be done on this     treatment and whether it could be offered in the NHS in the future.   "
9615|NCT03160079|"     This is a Phase I/II study of blinatumomab in combination with pembrolizumab in adult     patients with relapsed or refractory B-lineage ALL The primary objective of this study is to     determine if the addition of pembrolizumab to blinatumomab improves the overall response rate     (CR+ CRh) relative to blinatumomab alone in adult subjects with relapsed or refractory B-cell     acute lymphoblastic leukemia with high bone marrow lymphoblast percentage (>50%     lymphoblasts).   "
9616|NCT03160066|"     Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have     potential benefits for the management of stress-related conditions. The majority of studies     have focused on animal models. Preclinical studies have identified the Lactobacillus     Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours,     physiology and cognitive performance. Whether such preclinical effects could be translated to     healthy human volunteers remains unknown.   "
9617|NCT03160053|"     Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical     appearance and induration of lesions.   "
9618|NCT03160040|"     This study is a retrospective, observational study to evaluate minocycline use in     participants under real world conditions.   "
9619|NCT03160027|"     A recent study (Saltmarche et al., 21017) examined the effects of photobiomodulation (PBM), a     kind of light therapy that uses red or near-infrared light to heal and protect tissue that     has either been injured, is degenerating, or else is at risk of dying, in 5 older adults with     dementia. After 12 weeks of PBM treatments, delivered with a commercially available, wearable     device, the patients with mild to moderately severe dementia showed improvements on the     Mini-mental State Exam (MMSE, p<0.003) and Alzheimer's Disease Assessment Scale-cognitive,     ADAS-cog, p<0.03). The caregivers, who kept daily journals of their experiences during the 12     weeks of PBM treatment, reported better sleep, fewer angry outbursts, decreased anxiety and     wandering in their loved-ones with dementia. The goals of this trial are to: (1) replicate     this finding in a larger group of individuals with dementia and (2) to examine the underling     brain mechanisms behind the changes in cognitive function.   "
9620|NCT03160014|"     Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild,     Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.   "
9621|NCT03160001|"     Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis   "
9650|NCT03159624|"     The purpose of this study is to demonstrate the utility of porcine small intestinal submucosa     (SIS) as a graft material that may aid in the natural healing process of freshly exposed bone     and cartilage in the nasal cavity.   "
11179|NCT03139578|"     This will be a 2 period one-day, double-masked, randomized, repeated measures,     non-dispensing, cross-over study where the main purpose of this study is to compare the     performance of a new daily disposable silicone hydrogel lens with that of an existing similar     lens.   "
9622|NCT03159988|"     Heart failure (HF) is the major cardiovascular disease that continues to grow in prevalence,     largely due to aging of the population. HF is described as the inability of the heart to keep     up with the demands on it and, specifically, failure of the heart to pump blood with normal     efficiency. Cognitive impairment (CI) is common in HF patients, resulting in a person having     trouble remembering, learning new things, concentrating, or making decisions that affect     their everyday life. Patients with HF have been show repeatedly to have trouble remembering     and learning new things when compared to the general population. Patients with demonstrated     CI have a significantly increased risk of developing dementia (memory loss). It is believed     that the reason HF patients have a higher risk of CI is possibly due to less blood reaching     the brain and an overall inflammatory process occurring in the body including the brain. To     date there are no known therapies that can help treat CI caused by HF.      A substance, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the brain.     Early studies in humans have shown it to be safe. This substance is naturally produced in the     body and works by activating areas in the brain involved in memory. Investigators believe     that Ang-(1-7) may be able to help lower the risk of loss of cognitive function in patients     with heart failure.      In this study, we will try to determine whether Ang-(1-7) is a safe and effective treatment     for cognitive impairment in HF patients.   "
9623|NCT03159975|"     The purpose of this study is to determine the safety, tolerability, and immunogenicity in     patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for     the prevention of relapse of tuberculosis.   "
9624|NCT03159962|"     the effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal     parameters is still controversial because very little has been written regarding the behavior     of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the     phase 1 treatment intervention. The reported significant occlusal improvement could be     attributed to other reasons, ie, skeletal growth or the use of additional appliances during     transition from mixed to permanent dentition. Moreover, the majority of the studies show some     limits: they are not randomized, they are not prospective, and they have no control group or     they use patients from growth studies as a source for the control group. The primary     objective of the present investigation was to conduct a pilot randomized controlled trial     (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or     banded RMEs compared with an untreated Class II control group   "
9625|NCT03159949|"     An adapted sprint interval training protocol involving 2-3 repeated 20-second sprints     separated by 2-3 minutes rest (termed reduced exertion high- intensity interval training     (REHIIT)) has been developed and has been shown to promote fitness benefits. This data shows     how little exercise one may need to improve cardiorespiratory fitness, provided they are     willing to work very hard. However, it is unknown whether the benefits of REHIIT are because     of the all-out nature of the sprint efforts themselves or the pattern of completing sprints     with relatively short (i.e., minutes) rest periods within a workout session.      We are inquiring whether performing the same number and style of sprints with prolonged rest     (i.e., 1-4 hours of rest in between sprints) is equally effective for improving aerobic     fitness when compared to more traditional sprint interval training with 2-3 minutes of rest     between sprints. Such information may make the effectiveness of sprint training more     accessible and approachable for individuals unwilling or unable to plan a purposeful REHIIT     exercise session into their day. If the rest interval could be prolonged then it may be     possible to perform a few sprints as exercise snacks throughout the day without the need     for a structured interval training session.   "
9626|NCT03159936|"     Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus     erythematosus with or without concurrent SLE.   "
9627|NCT03159923|"     The aim of this study is to improve the definition of the two main types of secondary     tricuspid regurgitation.   "
9628|NCT03159910|"     Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to     Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder     complaints.      Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised     and home-based shoulder exercises, and advice from a health and safety consultant on     workplace interventions, will reduce shoulder exposures and shoulder complaints more     effectively than an individual-oriented control intervention with home-based shoulder     exercises and written general advice on workplace interventions.   "
9629|NCT03159897|"     The FIL-Rouge is a randomized, open-label, multicenter, phase III, 2-arm study. The primary     objective is to compare efficacy and tolerability of the intensified variant     'dose-dense/dose-intense ABVD' (ABVD DD-DI) with an interim PET response-adapted ABVD program     as upfront therapy in advanced-stage classical Hodgkin Lymphoma (HL).   "
9630|NCT03159884|"     To assess the efficacy of intravitreal injection of 0.5 mg conbercept in patients with     polypoidal choroidal vasculopathy (PCV) and explore the optimal route of administration.   "
9631|NCT03159871|"     A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical     outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the     suturing time during C-Section.   "
9632|NCT03159858|"     The FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE H&L-B ONE-SHOT™ INTRODUCTION SYSTEM is     neither commercially available or available as part of a clinical trial. IRB approval of this     protocol was requested so that Cook, Incorporated may apply to the FDA for approval for     one-time use of this patient-specific device for compassionate use for patient AO. It is a     custom made endovascular device consisting of4 fenestrations for the celiac, SMA (superior     mesenteric) and left and right renal arteries.   "
9633|NCT03159845|"     Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT)     are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at     the moment of the graft. Patients of the Control group take only standard antimicrobial     prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of     Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are     performed on peripheral blood samples.   "
9634|NCT03159832|"     The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety     of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.   "
45299|NCT02692716|"     This trial is conducted globally. The aim of the trial is to investigate the cardiovascular     safety of oral semaglutide in subjects with type 2 diabetes.   "
9638|NCT03159780|"     Clear-lens extraction has been considered as first-line therapy for primary angle closure     glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative     visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG     patients. We intend to make biometry examination for Chinese PACG patients, to obtain     keratometry (K) , axial length (AL) and so on, and demographics data will also be recorded.     We will study the prevalence of corneal astigmatism before glaucoma surgery in Chinese     patients with PACG. Furthermore, differences of corneal astigmatism between primary     angle-closure glaucoma and cataract patients will be explored. Finally, the prevalence of     corneal astigmatism before glaucoma surgery in Chinese patients with PACG will be portrayed     and can be instructive to the IOLs' manufactering.   "
9639|NCT03159767|"     This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of     spinal movement in a group of patients with axial spondyloarthritis.   "
9640|NCT03159754|"     When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the     infection and inflammation get worse, the appendix can die or burst, leading to a larger     infection or even pus pockets around the appendix. This is called complicated, or perforated,     appendicitis. Three common treatments for complicated appendicitis are        -  appendectomy (removal of the appendix) right away        -  appendectomy several weeks after the diagnosis        -  treating the appendicitis without performing an appendectomy      This study seeks to determine which of these three approaches is most cost-effective in     children with complicated appendicitis.   "
9641|NCT03159741|"     Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation     in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit     the bone resorption. However, the mechanism is unknown. In the present study we will     investigate the mechanism of action using a receptor specific inhibitor.   "
9642|NCT03159728|"     In Colombia as in the world, chronic diseases occupy the first places of death being     cardiovascular, chronic respiratory diseases and diabetes mellitus are the most prevalent.     The caregiver burden is reflected as an experience of constant attention, this routine is     shown in the changes they undergo in their life, and the emotions cope at different stages of     the process that arises chronic non-communicable disease from their family in demands care.     Methodology: a randomized controlled trial (RCT) will be conducted to determine the effect of     skill care program Caring for the caregivers to reduce the burden of care in carers of     people with chronic non-communicable University Hospital in Los Comuneros in Bucaramanga.     Results and expected impact: bring to the lines of research: Community Care: improve the     ability of the care of family caregivers at home and increase the quality of life that people     are able to chronicity. Clinical Care: Strengthens care ability of caregivers who are in     health institutions. Management and Care Management: Promoting implementation, monitoring and     evaluation of the educational proposal in order to create a network of support for family     caregivers in Santander in extending the results to other institutions. The project results     should allow participation in Extension and Social Projection, whose results will allow the     implementation of an effective educational model for the care of patients with chronic     non-communicable disease in Colombia. In addition, the consolidation of the alliance between     Everest group at the University of Santander with the Latin American Network of chronic     patient care and clinical Communards of Bucaramanga projects. Finally it is expected to     consolidate training in the area of research students in undergraduate and graduate programs     at the University of Santander.   "
9643|NCT03159715|"     The objective of the present project is to study the differential effectiveness of three     brief self-applied via the Internet interventions for mild to moderate depression: a global     protocol composed of several therapeutic components (psychoeducation, cognitive     restructuring, behavioral activation, positive psychology, and relapse prevention), a     protocol just based on behavioral activation (BA), and a protocol just based on positive     psychology (PP). The purpose is to know the specific contribution of each therapeutic     components in the treatment of depression.   "
9644|NCT03159702|"     This is an open-label, single-arm, phase II study to determine the safety of propylene     glycol-free melphalan HCl (EVOMELA®), in combination with fludarabine and total-body     irradiation-based reduced-intensity conditioning for haploidentical transplantation. In     addition, the study evaluates the one-year progression-free survival of patients undergoing     this treatment.   "
9645|NCT03159689|"     The results from this study may help to explain if incorporating mixed nuts in a reduced     calorie diet will lead to weight loss.   "
9646|NCT03159676|"     Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is     a specialized form of radiotherapy used to treat prostate cancer with five treatments over     two weeks, compared with a conventional eight-week or longer treatment course. The purpose of     this trial is to investigate the effect that proton-based SABR has on quality-of-life in     patients with localized prostate cancer. The evaluation and treatment will otherwise follow     standard of care, and is not considered investigational.   "
9647|NCT03159663|"     Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation     factor VIII (in hemophilia A) or factor IX (in hemophilia B).      The deficiency is the result of mutations of the respective clotting factor genes.   "
9648|NCT03159650|"     Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade     0 with an estimated duration of at least 3 months. The interest in chronic total occlusion     (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to     20%, leading to important developments in dedicated equipment and techniques.      In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was     recommended to guide stent implantation in selected patients, and this recommendation was a     class IIa/level of evidence B.      In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy     calcification, and lack of visibility of path in the distal vessel increase procedural     difficulty   "
9649|NCT03159637|"     Laparoscopic surgery is now widely established.Laparoscopic surgery involves insufflation of     a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. The     raised intra-abdominal pressure of the pneumoperitoneum, alteration in the patient's position     and effects of carbon dioxide absorption cause changes in physiology, especially within the     cardiovascular and respiratory systems.   "
9651|NCT03159611|"     Purpose of the study:        -  To assess clinical efficacy of Tenoten for children liquid dosage form (oral drops at a          daily dose of 10 drops, for 12 weeks) in the treatment of sequelae of perinatal injury          to central nervous system (CNS) (cerebral hypoxic-ischaemic event and/or grade I or II          intracranial haemorrhage).        -  To assess safety of Tenoten for children liquid dosage form (oral drops at a daily dose          of 10 drops, for 12 weeks) in the treatment of sequelae of perinatal injury to CNS          (cerebral hypoxic-ischaemic event and/or grade I or II intracranial haemorrhage).   "
9652|NCT03159598|"     Drains are routinely utilized in breast reconstruction when using abdominal tissue of the     patient to remove fluid buildup while the body heals after surgery. However, drains are     associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and     outpatient visits. Drains can also serve as a site of origin for infection as the system is     not completely closed, and infectious organisms could theoretically use the drain as point of     entry.      This proposed study investigates a potential novel mechanism to prevent the development of     seromas (pockets of clear fluid which can develop after surgery) in patients who undergo     breast reconstruction with their own abdominal tissue. By eliminating the required use of a     drain, the study team expects patients to have less pain and use less pain medication, as     well as more satisfaction with their overall surgical experience.   "
9653|NCT03159585|"     The main purpose of this trial is to investigate the safety and tolerability of     TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed     advanced solid tumors including bone and soft tissue sarcoma, melanoma, liver cancer,     esophageal cancer, breast cancer, bladder cancer, prostate cancer, thyroid and ovarian     cancer. The patients must meet the two criteria: human leukocyte antigens (HLA)-A*0201+ and     NY-ESO-1 positive cells≥25% by immunohistochemisty.   "
9654|NCT03159572|"     To investigate the frequency and clinical significance of Homologous Recombination Deficiency     (HRD) in Japanese patients with ovarian cancer (including Fallopian tube cancer and primary     peritoneal cancer).   "
9655|NCT03159559|"     This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary     microvascular perfusion in patients with ischemic heart disease by CMRI.   "
9656|NCT03159546|"     This is a pivotal, non-randomized, single arm, multi-center, prospective, non-significant     risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.   "
9657|NCT03159533|"     The proposed study Project IMPACT: CHW Intervention is part of a larger study examining the     efficacy, adoption, and impact of integrated EHR-based decision-support and physician     feedback interventions with community health worker (CHW)-led self-management and coaching     support for South Asian patients with uncontrolled hypertension. This is a randomized control     intervention utilizing community health worker (CHW)-led self-management and coaching support     for South Asian patients with uncontrolled hypertension at PCP clinics in New York City.   "
9658|NCT03159520|"     To compare the analgesic property of acupressure with NSAIDs (Ibuprofen) in controlling pain     following orthodontic treatment. This will be achieved by assessing the effectiveness of     acupressure in controlling pain and discomfort by measuring the degree of pain relief after     bonding of brackets to teeth and placement of initial archwire.   "
9659|NCT03159507|"     Determine whether personal optimization of the Omega-3 index improves cellular metabolism and     quality of life (according to the SF-36 form).   "
9660|NCT03159494|"     10 patients with type 2 diabetes participated in a training-intervention consisting of 8     times of High-Intensity Training (HIT). Before and after the intervention the patients were     tested regarding Oral Glucose Tolerance Test, blood pressure, weight and fat% and VO2max.   "
9661|NCT03159481|"     African Americans (AA) are at higher risk to develop and go blind from glaucoma than     Caucasians. While glaucoma medications can help delay disease progression and possible     blindness, problems with poor adherence have been documented for both racial groups, with a     greater prevalence among AA. Of the very few interventions targeting glaucoma medication     adherence studied to date, several methodological limitations persist. For example, few have     been subjected to rigorous randomized clinical trial (RCT) designs, the intervention itself     was designed and studied predominantly among Caucasians and thereby limiting     generalizability, the effects on adherence have been short-term, most have been evaluated on     small sample sizes, and/or the focus of the intervention was solely on providing patient     education regarding eye disease and management. Needed in this important yet understudied     area are culturally-relevant, health promotion-based approaches which are 1) targeted to high     risk populations, 2) theoretically driven, 3) relevant to the beliefs, language, and values     of underserved populations as well as challenges related to glaucoma medication adherence, 4)     designed to promote preparation and readiness to engage in healthy behaviors, and 5) train     patients in skills to use in order to more effectively problem-solve ongoing obstacles     related to adherence.      The investigators published a paper in the Journal of Glaucoma investigating determinants     related to objective medication adherence as measured by an electronic dosing aid (DA).     Findings revealed poorer rates of adherence among AA patients with glaucoma compared to     Caucasian patients with glaucoma. Evidence for racial differences in adherence have also been     increasingly documented in the glaucoma literature. In a follow-up study with focus groups of     AA's with glaucoma that was published in Optometry and Vision Sciences, the goal was to     identify the specific barriers and facilitators related to glaucoma medication adherence     among this high-risk group. Several key themes emerged such as patient, provider, and     socioeconomic factors, along with barriers in views of health, perceived harm from treatment,     costs, avoidant coping styles, forgetfulness, and in eyedrop administration/scheduling. The     investigators used these results along with guidance from a consumer advisory board     consisting of AA patients with glaucoma in order to develop and pilot test the resulting     culturally relevant, health promotion-based intervention. The pilot data demonstrated     feasibility and favorable preliminary efficacy for the intervention to significantly improve     medication adherence to further pursue in a clinical trial.   "
9662|NCT03159468|"     Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the     majority of these assaults. Despite well-intentioned prevention efforts, this pandemic     continues unabated, warranting the development of novel and innovative approaches to the     reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two     brief online emotion regulation interventions for reducing alcohol-related sexual aggression     in heavy episodic drinking young men with a sexual aggression history. Previous research     suggests that emotion regulation difficulties are associated with both alcohol consumption     and aggressive behavior. Despite the potential prevention utility of improving sexually     aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual     aggression, this approach has yet to be explored. Thus, this study evaluates the effects of     two brief online ER interventions - cognitive restructuring and mindfulness - on men's     emotion regulation during a sexual aggression-related analogue. Additionally, these effects     will be evaluated during both sober and intoxicated states through a laboratory- based     alcohol administration experiment.   "
45601|NCT02688738|"     The purpose of this study is to evaluate the ability of oral doxycycline to decrease the     colonization of Propionibacterium acnes in the dermis of the shoulder.   "
9664|NCT03159442|"     AZD8871 is a new chemical entity possessing long-acting dual-pharmacology (muscarinic     receptor antagonist and β2 adrenoceptor agonist [MABA]) in a single molecule. This type of     agent presents a novel approach to the treatment of chronic obstructive pulmonary disease     (COPD) and potentially asthma (in combination with an inhaled corticosteroid). AZD8871 is     being developed for inhalation, formulated with alpha lactose monohydrate and delivered by     dry powder inhaler (DPI) that allows delivery of a single dose of the study drug.      The primary objective is to investigate the safety and tolerability of AZD8871 at steady     state in healthy male Japanese subjects.   "
9665|NCT03159429|"     The main objective of this study is to measure the effect (at 3 months) of dyspnea control     rehabilitation with nasal ventilation versus standard rehabilitation, in dyspneic patients     with hyperventilation syndrome.   "
9667|NCT03159403|"     This study is a retrospective, observational study to evaluate oritavancin use in     participants under real world conditions.   "
9668|NCT03159390|"     Intravenous infusion of stable tracers of ornithine, glutamine, glutamate, and glycine will     be performed, and collect blood samples, urine samples, and muscle biopsies to evaluate the     effect of a continuous oral intake of phenylacetate salt of ornithine (OP) on its metabolic     fate.   "
9669|NCT03159377|"     We will perform an ultra low-dose CT (ULDCT) in addition to a regular chest CT scan for adult     patients undergoing a clinically indicated chest CT. Using a recently developed     computationally efficient algorithm for the denoising of ULDCT scans after image     reconstruction, we will compare the sensitivity, specificity and accuracy of lesion detection     with the ULDCT as compared to the regular CT scan.   "
9670|NCT03159364|"     Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) result in significant morbidity and     mortality in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral     drugs are usually used for prophylactic purposes and treatment after early detectable viral     load. Unfortunately, some patients may develop resistance to antivirals. In addition to     patient with HSCT, immune compromised patients may also been the targets for these     opportunistic viruses. Thus in this study, the safety and efficacy of CMV and EBV specific     cytotoxic T cells (CTLs) will be determined.   "
9671|NCT03159351|"     This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the     effectiveness of rTMS in treating depression after basal ganglia ischemic stroke and to     examine whether such effects are related to restoration of white matter integrity.Sixty-six     participants will be recruited from three centers and randomized with a 1:1 ratio to receive     active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The     data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the     commencement of the treatment.   "
9672|NCT03159338|"     Patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy     will be included in the study.One side of the osteotomies randomly will be considered as     study group and another side as a control group.In the study group , platelet rich fibrin     will be placed after osteotomy and before rigid fixation.In the control group, fixation will     be done without Platelet-rich Fibrin (PRF).Neurosensory disturbance will be evaluated 6 and     12 months after surgeries.   "
9673|NCT03159325|"     Heart disease is a leading cause of death and disability in Canada. Providing social and peer     supports has been proven to help patients manage their health and stay out of the hospital.     The use of telehealth has opened up a wider possibility of patients receiving peer support     while staying in their homes and communities. The investigators plan to study a new     application for supporting patients through peer support. The application can be accessed by     smartphone, tablet and desktop/laptop computer. Over two years, the investigators anticipate     that the application (Healing Circles) will improve patient self care and reduce     hospitalizations.   "
9674|NCT03159312|"     Obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. The     current lifestyle, causes a gradual increase in weight both in the adult population and in     the child population. Among their treatments is bariatric surgery. About which there is     little evidence in the literature regarding the health condition developed by patients     operated on the same. Objective: To know the influence of a moderate exercise program on     health status in patients operated on with bariatric surgery. Methodology: A controlled     clinical trial, the population will consist of 52 women and 18 men. Coming from the     consultations of bariatric surgery of the Clinic of the Maule - Talca. In the period between     March 2017 and March 2018. It will be selected following a non-probabilistic sampling and for     convenience. Results Analysis: The variables used in this study will be: cardiovascular     function, respiratory function, strength, health perception, anthropometric measures and     functional capacity to perform exercises. The Shapiro-Wilk normality test will be performed     to determine the distribution of the data to be analyzed. The t-student test or its     nonparametric counterpart will be applied to compare two variables. To compare three or more     variables, the ANOVA or Kruskal-Wallis test will be used depending on the results of the     normality test.   "
9710|NCT03158844|"     The population of inpatients is large in Zambia; however, because of poor linkages between     hospitals and community HIV care, there are few data to analyze their engagement in HIV care     before and after hospitalization. The goal of the study is to learn more about Zambian adults     who are HIV-infected and get hospitalized. The purpose of this study is to gather formative,     preliminary data, to be used in future grant applications to improve linkage and engagement     in HIV care in Zambia.   "
9712|NCT03158818|"     Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood     donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is     low in Zambia and the Ministry of Health is in early stages of development of guidelines for     HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to     characterize the clinical features of chronic HBV infection at UTH and describe treatment and     care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5     years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis     and liver cancer.   "
9944|NCT03155776|"     Aspiration of gastric contents can be a serious anesthetic related complication. Gastric     antral sonography prior to anesthesia may have a role in identifying pediatric patients at     risk of aspiration. The investigator examined the relationship between sonographic antral     area and endoscopically suctioned gastric volumes infants.   "
9675|NCT03159299|"     The aims of this study are:        1. To translate an evidence-based diabetes self-management education (DSME) program, Yo          Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro          Popular clinics in Mexico. The program will be adapted through a collaborative team of          diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians,          nurses and adults with type 2 diabetes (T2D) in Mexico City, Mexico. This will include          development and testing of a theory-based mHealth (pictorial text-messaging) component.        2. To evaluate the feasibility (process of implementation, fidelity of sessions,          attendance, attrition), acceptability (interviews with nurse, CHW, participants) and          preliminary efficacy of Yo Puedo!+mHealth in adults with T2D in Mexico City. A          randomized, controlled pilot study design will be used in which 40 adults with T2D are          randomized to the Yo Puedo! + mHealth or a wait-list control condition with the          hypothesis that clinical [A1C, body mass index (BMI), blood pressure (BP)], T2D          self-management, and self-efficacy outcomes will be greater in You Puedo!+mHealth          participants compared to the wait-list control condition at 3 and 6 month follow-up. A          secondary hypothesis that the Yo Puedo! + mHealth program is feasible and acceptable to          adults with T2D and providers and that fidelity of the program will be maintained.   "
9676|NCT03159286|"     The proposed research will be the first study to focus on experimentally manipulating both     injunctive and descriptive norms on social networking sites in order to elucidate the     relationship between alcohol and abstainer displays on social networking sites and subsequent     alcohol cognitions, use, and related negative consequences. Based on literature focusing on     developmentally appropriate health models for adolescents, the Prototype Willingness Model     (PWM) assumes that health-risk behaviors occur either when individuals have developed     intentions to engage in a risk behavior (and these intentions vary as a function of attitudes     and perceived injunctive norms) or through willingness to engage in risks (which varies as a     function of perceived vulnerability to negative consequences, perceived descriptive norms ,     and prototypes). To fully understand the relationships between alcohol abstaining displays on     social networking sites, we will examine 1) the role of descriptive and injunctive abstainer     and user norms, when experimentally manipulated with SNS profiles, on willingness and     intentions, subsequent alcohol use and related negative consequences among adolescents (age 1     5-20) 2) whether intentions and willingness mediate the relation between our experimental     manipulation and subsequent alcohol use and negative consequences and whether 3) individual     differences in social influence moderate the effect of the experimental manipulation on     intentions, willingness, alcohol use, and negative consequences. We will test these aims by     recruiting a community sample of adolescents (N = 300), living in the greater Seattle     metropolitan area. Participants will complete a web-based baseline assessment and participate     in an in-person experimental manipulation in which they are either assigned to see same-sex     social networking site profiles of alcohol abstainers, abstainers +users, or a control     condition where neither user or abstainer information will be provided. Immediately after the     manipulation, participants will answer a series of questions about the profiles they just     viewed and their alcohol-related cognitions. Participants will also complete a one-month in     person follow up assessment to test for impacts on intentions, willingness, alcohol use, and     related negative consequences. Additionally, individual differences in social influence will     be examined as possible moderators o f the relationship between SNS-portrayed norms and our     primary outcomes. This study is both significant and innovative in that it uses a theoretical     perspective to experimentally test the impact of alcohol content, in particular abstainer     norms, on Facebook on adolescent alcohol use and related cognitions. The results have the     potential to inform preventative interventions while addressing NIH priorities.   "
9677|NCT03159273|"     The purpose of the present study is to explore the effects of a dietary nitrate supplement on     immunity, mood, cardiovascular activity, and lung function during and following final exam     stress in both healthy and asthmatic individuals.   "
9678|NCT03159260|"     The purpose of this study is to determine the effect of Theraworx/[pH]uel on the frequency     and severity of night-time cramps and spasms symptoms, including quality of life, depression     and sleep quality when compared to a placebo.   "
9679|NCT03159247|"     The purpose of this research study is to test the impact of two personalized technology based     programs that may help improve adherence to glaucoma medications.   "
9680|NCT03159234|"     Diabetes is the most common medical complication of pregnancy in the united states four to     five percent of pregnancies are complicated by diabetes.      Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes     mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational     diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87     percent . The prevalence of pregestational diabetes has been increasing due to the increasing     prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical     management of pregestational diabetes involves frequent monitoring of blood glucose levels     with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is     important because maintenance of maternal blood glucose concentration at or near     normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as     miscarriage , congenital anomalies , macrosomia and fetal death.   "
9681|NCT03159221|"     This is a randomized, controlled pilot trial of Behavioral Family Systems Therapy for Teens     with Type 2 Diabetes (BFST-DM2), an individual psychological intervention tailored to meet     the needs of teens with type 2 diabetes. It is hypothesized that this behavioral family     intervention will be feasible to implement with teens with type 2 diabetes and will have     positive effects on treatment adherence, health outcomes like weight status and metabolic     control, and psychological outcomes.   "
9682|NCT03159208|"     The purpose of the study is to establish clinical determinants of poor cognitive and physical     functional outcome of CCI patients so that the investigators may develop and validate a     multi-dimensional clinical prediction model to more effectively inform decision making     earlier in the course of the ICU care. The investigators hypothesize that multiple premorbid     and acute factors measured early in the course of CCI will have strong independent     associations with functional recovery. The investigators further hypothesize that social and     economic factors are associated with long-term functional outcomes independent of the acute     clinical problems.   "
9683|NCT03159195|"     To describe patient demographics, clinical characteristics, treatment patterns and clinical     outcomes of adult female patients who have received palbociclib combination treatments in     line with regional licensed indications in real world settings across multiple countries.   "
9684|NCT03159182|"     The purpose of this study is to determine if the use of silicone material inserts within     pressure garments is effective in decreasing hypertrophic burn scar formation as compared to     standard pressure garment therapy.   "
9685|NCT03159169|"     This is a prospective, open label, multicenter feasibility study to evaluate the safety and     therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation     down to arm/shoulder/upper back   "
9740|NCT03158454|"     The purpose of this study is to investigate whether patients undergoing surgical treatment     (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of     higher scores in validated patient reported outcome measurements, compared to a Group of     patients with FAI syndrome where the capsule is left open at the end of the surgical     procedure.   "
9741|NCT03158441|"     Introduction The most common breast cancer originates within the breast milk ducts, and is     called ductal carcinoma. After the stage where the cancer is found only within the ducts, it     invades the breast tissue beyond the ducts, and becomes invasive cancer (Infiltrating Duct     Carcinoma). Breast cancer located within the ducts is called intra ductal carcinoma in situ-     DCIS. DCIS is the developing cancer and usually does not metastasize. Another type of breast     cancer originates within the breast lobules and is call lobular carcinoma.      Recently at the Weizmann Institute, Prof. Hadassa Degani and her group developed and imaging     technique using breast MRI. This technique allows to map the three-dimensional structure of     the milk ducts in the breast. The method is based on measuring the random movement (Brownian     motion) of water molecules (diffusion) in different directions in the breast tissue,     collecting diffusion images by using magnetic field gradients in different directions,     allowing imaging of Diffusion tensor Imaging -DTI. Movement of water molecules within a     unified solution is usually random and uniform in all directions, but the internal structures     in biological systems (such as cells, pipelines, fiber) restrict the movement of water in     certain directions. The DTI method exploits this feature by measuring the diffusion in     various directions, thus enabling calculating images of biological structures [1]. This     method was proved to be effective in mapping the brain's white matter fibers and is used     routinely in clinical tests used to monitor neurological injuries [2-4]. This method was used     for milk ducts mapping within breast tissue at the Weizmann Institute. The system that was     developed at the Weizmann Institute, showed that the movement of water molecules along the     milk ducts is faster than their movement across the ducts and therefore it was possible using     this method to map the breast ductal system. Also this method showed that it is possible to     detect and diagnose malignant changes within breast and to distinguish them from normal     tissue and benign tumors using DTI. Changes in cell density and arrangement causes changes in     the directional diffusion coefficients and the differences between them [5-9] Research Plan     Summary A prospective preliminary study to evaluate the correlation between the DTI analysis     of breast MRI and the results of conventional contrast enhanced breast MRI.      The patients enrolled for the study will be women scheduled for breast MRI due to high risk     screening or pretreatment evaluation. The patients will fill in a form regarding: age,     hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely     filled out in our institution). They will then undergo a breast MRI scan, using the routine     protocol in our institution. This will be directly followed by a DTI sequence, which takes     about 10 minutes in addition to the regular examination. The DTI sequence is routinely used     in other imaging institutions, as part of the breast MRI protocol.      The exams will be read on our regular work stations, and in addition will be analyzed by     software developed at the Weizmann Institute. Both interpretations will then be compared to     each other and to clinical and pathological data   "
9686|NCT03159156|"     For a number of years, researchers have examined the effects of the muscle-tensing technique,     Applied Tension (AT), on blood donation-related vasovagal symptoms and donor retention. AT     was developed originally to reduce symptoms and avoidance behaviour in people with strong     fears of blood and needles (phobics). It was based on the idea that exercise-related     increases in blood pressure might be able to counteract the effects of stimuli that lead to a     decrease in delivery of blood to the brain. AT was adapted for non-phobic blood donors and     significant reductions in self-reported vasovagal symptoms and the need for nurse-initiated     treatment as well as increases in donor retention were observed in some groups.      That said, individual response to AT is quite variable. This is probably related to recent     research indicating that exercise-related maintenance of heart rate and blood pressure plays     only a minor role in reducing vasovagal symptoms. Rather, AT appears to be working at least     in part by regulating breathing and reducing the possibility of hyperventilation. Pilot     results suggest that a novel intervention aimed specifically at breathing may be more     effective and reliable than traditional AT. To evaluate this idea, 408 blood donors at mobile     clinics in colleges and universities will be assigned randomly to four conditions. In brief,     5-minute preparation sessions using a notebook computer, donors will either learn a     respiration control technique to avoid hyperventilation, AT, both, or neither. As a     manipulation check and also a means of examining mechanisms of the interventions, e.g., the     possibility that AT may work by regulating breathing and CO2, participants will wear     non-invasive portable capnometers while they are giving blood. Outcome will also be assessed     by self-report of vasovagal symptoms, observational data, and number of return visits to a     blood clinic in the following year verified by the provincial blood collection agency,     Héma-Québec. As a secondary aim, the research will examine possible moderating effects of     pre-donation anxiety and sex.      The development of simple, effective approaches to reduce vasovagal symptoms during blood     donation has the potential to improve the blood donation experience and blood donor retention     as well as encourage people who have never given blood to consider the procedure. It will     also improve medical and dental care more generally given the use of needles in so many     procedures.   "
9687|NCT03159143|"     The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a     combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer     (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a     25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable     objective response rate, time to disease progression and survival were also assessed.   "
9688|NCT03159130|"     This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric     surgical population and seeks to identify if a quantifiable improved post-operative course     occurs in patients receiving a catheter filled with local anesthetic versus that achieved by     patients who receive a catheter filled with injectable saline.   "
9689|NCT03159117|"     The purpose of this research study is to learn about the safety and effectiveness of the     study drug, PF-06688992. Before this study, PF-06688992 has never been given to people.      PF-06688992 is a targeted therapy for people with cancer. The investigators linked a     chemotherapy drug to an antibody (protein found in the blood). The antibody will connect to     GD3 which is found on most melanomas but on very few other cells in the body. The     investigators hope that in this way, it will deliver this chemotherapy directly to the     melanoma and not to normal tissues.   "
9690|NCT03159104|"     Purpose of the study:        -  To assess efficacy of Tenoten for children® in children with specific developmental          disorders of scholastic skills.        -  To assess safety of Tenoten for children® in children with specific developmental          disorders of scholastic skills.   "
9691|NCT03159091|"     The purpose of this study is to obtain additional data on efficacy and safety of Rengalin in     the treatment of cough in patients with stable obstructive pulmonary disease   "
9692|NCT03159078|"     The purpose of this study is to assess the safety and efficacy of polymyxin B as monotherapy     versus a combined polymyxin B-carbapenem therapy against MDR gram negative infections. The     investigators intend to evaluate if this synergistic drug regimen correlates with improved     outcomes against gram-negative infections in critically ill patients including: better     clinical resolution, reduced length of stay at hospital, reduced length of stay at the     intensive care unit, and less recurrence of infection.   "
9693|NCT03159065|"     Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and     insulin responses and hence promote well-being. It has previously been observed that     consumption of a bilberry drink decreases the postprandial insulin demand. In the present     study, the impact of probiotic fruit beverages with different polyphenol profiles on the     postprandial levels of glucose and insulin, were investigated.   "
9694|NCT03159052|"     The purpose of this study is to obtain information on efficacy and safety of SHR3824 over 24     weeks and 52 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing     the effect of SHR3824 to placebo when given in oral doses.   "
9695|NCT03159039|"     Respiratory diseases are a major morbidity and mortality causes of neonatal requiring     mechanical ventilation, especially in newborn preterm infants (PN), thus respiratory therapy     becomes increasingly necessary in order to minimize the effects of complications and improve     respiratory functions, increasing mucociliary transport with techniques that consist of     manual maneuvers to bronchial hygiene, such as vibro associated with postural drainage and     prolonged slow exhalation. Objective: To compare and analyze the effects of convensional     physiotherapy (CP) versus prolonged slow exhalation (PSE) in heart rate (HR), and respiratory     rate (RR), O2 saturation (SpO2) and Tidal Volume (TV), time permanence of mechanical     ventilation (TMV) and number of extubation failure (EF) in premature infants on mechanical     ventilation (MV). Methods: Randomized clinical trial conducted in the neonatal intensive care     unit of the General Hospital Itapecerica da Serra Seconci OSS SP, comparing two physical     therapy techniques applied to preterm infants on mechanical ventilation.   "
9696|NCT03159026|"     The natural history of patients with PA-AMV has not been systematically studied before and     there is no published data in the literature about this condition since 1980. There is no     evidence-based approach to care of these patients, particularly the younger patients who may     no come to medical attention until significant cardiac problems develop. Through systematic     review of existing medical records on essentially all known patient with this condition,     investigators plan to develop an evidence-based management plan for preventive care of these     patients.   "
9711|NCT03158831|"     The investigators are conducting a prospective study to determine the safety and outcomes of     placebo-controlled graded drug challenges without prior skin testing in patients with a     low-risk history of antibiotic hypersensitivity reaction based on history alone. The     investigators hypothesize that the rate of reaction to graded drug challenges without prior     skin testing in patients with a low-risk history of drug hypersensitivity reaction based on     history alone will not be meaningfully more than the rate of reaction to placebo. The     investigators hypothesize that the rate of adverse reactions to drug challenges without prior     skin testing will not be meaningfully more than the rate of adverse reactions with prior skin     testing as was observed in the investigators' historical clinic cohort.   "
9697|NCT03159013|"     Exposure to pyrethroid pesticides is a growing concern in the workplace especially since they     are also present in the diet of the general population. It is important to monitor human     exposure to these contaminants. Exposure to pyrethroids may occur by multiple routes of     exposure (oral, inhalation and dermal), such that it is difficult to assess absorbed doses     from external exposure assessments. Biological monitoring, which consists of measuring     urinary metabolites, is now recognized by the scientific community as a preferred approach to     assess exposure to this type of compound. These metabolites are biotransformation products     produced in the human body from the exposure compounds. However, interpretation of these     biological monitoring data requires a proper knowledge of the kinetic behavior and thus the     fate of the substance of interest in the human body in order to link levels of biomarkers in     individuals to actual absorbed doses. Human kinetic data are still poorly documented in the     case of pyrethroids. The study in volunteers exposed to pyrethroids in controlled conditions     will allow acquiring new urinary and blood profiles to refine and address uncertainties in     the toxicokinetics of lambda-cyhalothrin following oral and dermal exposure. Those data will     serve to build a toxicokinetic model to predict absorbed doses in workers from urinary     metabolite measurements and therefore better assess health risks.   "
9698|NCT03159000|"     Several observational studies have shown improvement in episodic migraine with the use of     greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did     not show a decrease in frequency of episodic or chronic migraine; however, there has never     been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for     headache, and there has been no determination of guidelines for selection of patients who     would be most likely to respond to GONB. In light of the above, the investigators propose a     double-blind, placebo-controlled, randomized trial examining the use of GONB with     lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial     are expected to guide more appropriate therapeutic management of these participants and the     optimal use of this procedure. 50 subjects will be entered into this study. This study is     being conducted at Thomas Jefferson University only.   "
9699|NCT03158987|"     This retrospective observational study aims at the examination of regional differences in the     procedure of referral for serological HIV testing between eastern (new) and western (old)     German federal states.   "
9700|NCT03158974|"     This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and     efficacy of VIR007 when administered topically for up to 60 days to adults between the ages     of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.   "
9701|NCT03158961|"     Thyroid surgery has been developed as a new technique for zero scar in surgery by applying     transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating     the surgery which pierced through floor of mouth, cause severe tissue damage, high     complication, and conversion rates to open surgery and surgical difficulties due to     limitation of movement. Nevertheless, each report is still including small number of     patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has     been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case     was reported in local media in the late last year. Hence, this study is for evaluating the     feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong     Kong.      The following are the procedure of the study:        1. Recruit patients from the clinic.        2. Patients will receive treatment within 3 months        3. Patients will have different assessments like Ultrasonography assessment, Fine needle          biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2          week, post 1 month, post 3 month, post 6 month and post 12 month.        4. Patients will be monitoring by the same team after the study.   "
9702|NCT03158948|"     This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of     MOTREM versus placebo in adult patients with septic shock.   "
9703|NCT03158935|"     This is a phase 1b study for patients with metastatic (cancer has spread to various parts of     the body) melanoma and ovarian cancer. The main purpose is to examine the safety and efficacy     of administering pembrolizumab after receiving chemotherapy, tumor-infiltrating lymphocytes     (TIL) and low dose interleukin 2 (IL-2).      Patients will first receive either cyclophosphamide, or cyclophosphamide and fludarabine.     These are chemotherapy agents that prepare the body to receive TILs.      Patients are then infused with autologous TILs, a type of white blood cell that recognizes     tumor cells and enters them, thereby causing tumor cells to break down.      Following TILs infusion, patients will receive low-dose IL-2 therapy. This is a type of     protein that is intended to activate and stimulate the growth of cells in the patient's     immune system.      If the patient meets the required criteria, they will be given pembrolizumab, a monoclonal     antibody (drug made up of cloned immune cells) that is designed to block a protein called     programed cell death ligand 1 (PD-L1) which will allow the body's immune system to kill the     cancer cells.   "
9704|NCT03158922|"     BARCODE 1 is a screening study designed to investigate the role of genetic profiling for     targeting population prostate cancer screening. This study forms a pilot of 300 men, with the     view to continue to a future study of 5000 men.   "
9705|NCT03158909|"     This study evaluates the effect of earplugs and eyemask for delirium prevention among elderly     in-patients. Half of patients will receive earplugs and eyemask for use during the night and     information about orientation to time and space every night, while the other half will     receive only the time and space orientations.   "
9706|NCT03158896|"     This study evaluates the safety and effectiveness of two different doses of umbilical cord     derived, ex-vivo cultured and expanded Wharton's jelly mesenchymal stem cells (MSCTC-0010) in     the treatment of acute Graft versus Host Disease (aGVHD). The first 5 participants enrolled     in the study will receive a lower dose of MSCTC-0010. If none of the first 5 participants     have treatment-related serious adverse events (TRSAEs) for 42 days, then the next 5     participants will receive a slightly higher dose of MSCTC-0010.   "
9707|NCT03158883|"     This is a pilot, single center, open-label study to examine the ORR, safety, and toxicity of     avelumab in combination with SAR in non-responding and progressing NSCLC patients previously     treated with a PD-1 Inhibitor.   "
24871|NCT02960126|"     This study was designed in order to evaluate and compare the efficacy and safety between     aspirin and clopidogrel in the patient with low stroke risk Atrial Fibrillation (AF).   "
9713|NCT03158805|"     Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will     reduce body weight and improve metabolic variables in obese or overweight patients with BP     without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc     injection will display greater efficacy as compared to placebo in decreasing body weight in     patients with BP who are obese or overweight. To prove this hypothesis, investigators will     conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm     clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with     stable BP. The investigators have chosen BP rather than another SMI because it is the most     common SMI (more common than schizophrenia or schizoaffective disorder) and has a     particularly strong association with obesity.   "
9714|NCT03158792|"     This is a clinical trial including non-surgical patients, 70 years of age or older, with     renal impairment requiring pharmacological venous thromboembolism prevention during     hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both     dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney     function in different countries. Therefore, this study aims to evaluate the efficacy and     safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels,     thrombosis and bleeding events.   "
9715|NCT03158779|"     The aim of this phase II study is to assess the efficacy and safety of sequentially     integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with     unresectable pancreatic cancer.   "
9716|NCT03158766|"     Subclinical infection of the intervertebral disc after lumbar disc herniation surgery has     been correlated to chronic low back pain and vertebral endplate changes. The most commonly     reported agent is Propionibacterium acnes. However, the real incidence is unclear, as it has     been reported in some series ranging from 3.7% to 46%. Recently, a systematic review     concluded that there is a relationship between P. acnes and endplate changes, but, there are     so far no studies to verify whether the reported presence of that pathogen in the     intervertebral discs is due to local infection or whether intraoperative contamination     occurred during the collection of samples.      Thus, the main objective of this study is to estimate the incidence of subclinical infection     in patients surgically treated for lumbar disc herniation.      To this end, a prospective cohort study will be conducted with a minimum of 95 patients     between 18 and 65 years of age who have been submitted to surgery after failure of     conservative treatment. The extruded disc will be removed and cultured for bacterial     identification. As controls, the ligamentum flavum and the multifidus muscle, taken     respectively before and after removal of the herniated fragment will also be cultured.     Patients will be followed-up for a year and MRI will be done at the end of this period.   "
9717|NCT03158753|"     Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with     activation of the sympathetic nervous system, such as by pain stimulation, as a result of     involuntary contraction of the arterioles. Thus PI holds potential for use as a tool for     objective pain measurement, although its practical usefulness and dependability as such     have not previously been investigated.      The investigators aim to explore associations between changes in PI and onset of pain     following cessation of regional anaesthesia in alert patients following ankle fracture     surgery.      Methods:      The investigators report an exploratory, observational analysis of prospectively gathered PI     data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for     ankle fracture surgery as participants of the randomised AnAnkle Trial (EudraCT:     2015-001108-76). PI is measured on an unaffected extremity in approximately 20 consecutive     patients already included in the AnAnkle Trial at Herlev University Hospital, evenly     distributed between spinal anaesthesia (SA) and peripheral nerve block (PNB).      Both anaesthesia forms and pain medication regimes are standardised as part of AnAnkle Trial     and participants register pain scores on a 0-10 numeric rating scale every three hours and     register the time of cessation of anaesthesia identified by return of sensation to the ankle.     Morphine consumption is also registered.      The investigators will explore correlations of changes in PI to increases in pain upon     cessation of the regional anaesthesia and, secondly, differences in cessation related PI     changes with SA versus PNB.      Ethics:      All participants have already given informed, written consent for use of this data for the     AnAnkle Trial. All necessary ethical and legislative approvals have been obtained for     initiation of AnAnkle Trial in July 2015.   "
9718|NCT03158740|"     A large, persuasive, and ever-increasing body of evidence links chronic inflammation to     virtually all of the chronic diseases that cause the majority of disability and death in the     U.S., including diabetes, cardiovascular diseases (CVD), and cancer. Diet plays a central     role in the regulation of chronic inflammation. However, until investigators developed the     Dietary Inflammatory Index (DII)TM there had been no scientifically valid way to relate what     individuals eat to the capacity of foods consumed to modulate inflammation. The DII has now     produced an impressive research base that ranges from predicting blood levels of inflammatory     biomarkers; to a variety of health-related endpoints including cancer incidence and     mortality, diabetes, and CVD; to psychological endpoints including depression and cognitive     functioning. Watermelon is a member of the Cucurbitaceae family of gourds and is related to     the cucumber, squash, and pumpkin. Watermelon flesh (WM) is ~91% water by weight, and is a     rich source of bioavailable compounds including lycopene and other carotenoids, and vitamins     A and C, all of which have anti-inflammatory properties. Watermelon is already known to play     an effective role in reducing risk of chronic inflammation related conditions like coronary     heart disease. Connecting Health Innovations (CHI) through this proposal is committed to     developing a watermelon supplemented dietary intervention to reduce inflammation. The DII     provides a tool that will form the basis of a counseling/instructional system aimed at     helping patients and their providers to control chronic, systemic inflammation by improving     the diet with specific, actionable dietary recommendations, counseling, and expert     instruction. Our first aim is to refine and modify the DII-based intervention by developing     and incorporating several watermelon recipes which will score low (anti-inflammatory) on the     DII scale. Our second aim is to design and implement a two-arm intervention trial based on     watermelon-focused DII recommendations aimed at reducing levels of chronic inflammation in     Columbia, South Carolina; the two arms of this intervention study will be the DII-Based     Counseling System, including access to our Imagine Healthy Online Portal, and a general     health education control. Data will include questionnaires (e.g., demographics, health     history, stress, depression, self-efficacy for physical activity and diet, social approval,     social desirability), anthropometrics measures, physical activity monitoring, inflammatory     marker C-reactive protein (CRP), and ASA 24-hour dietary recalls. Baseline data collection     will be followed by a 12-week intervention period. The DII arm will receive in-person healthy     cooking and nutrition classes, along with physical activity and stress reduction activities.     Additionally, this arm will receive access to the Imagine Healthy Online Portal. The general     health control arm will receive weekly health education information. Linear mixed models     (LMM) will be used to determine whether the intervention arms are associated with the primary     outcome (i.e., CRP).   "
9719|NCT03158727|"     The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa     study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered     intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy,     to patients with severe community-acquired bacterial pneumonia (sCABP).      The completion of this study will contribute to the basic knowledge on stem cells and their     mode-of-action, and has a large translational character, i.e. to document the safety and     explore the efficacy of Cx611 in patients with sCABP.   "
9720|NCT03158714|"     The Alabama Healthy Marriage and Relationship Education Initiative (AHMREI), a large-scale     partnership among Auburn University and 9 additional implementation partners at Family     Resource Centers, implements multiple program activities that respond to family needs and     integrate comprehensive services to promote healthy marriages and relationships, as     authorized by the Claims Resolution Act of 2010 (Pub. L. 111-291). The purpose of this study     is to evaluate the efficacy of two selected couples education curricula- Elevate and Couples     Connecting Mindfully. The programs are intended to improve the well-being of individuals,     couples, and families in domains such as couple well-being, parenting skills, individual     skills, and economic stability.   "
9721|NCT03158701|"     .Cardiac affection in liver cirrhosis is a clinical condition characterized by impaired     diastolic relaxation and contractility with electrophysiological abnormalities.      .Cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients     without cardiac affection.      The suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are;     alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation,     sympathetic nervous system activation and changes in ion channels.      .As a component of cardiac involvement in cirrhotic patients fragmented QRS complex and     prolongation of the corrected QT interval has been documented in most of the cases with liver     cirrhosis (LC) and its prevalence increases with the severity of the disease   "
9747|NCT03158363|"     The investigators want to establish a new model of acute febrile disease by mimicking the     conditions seen in hospitalized patients in regards to inflammation, immobilisation and     fasting. In this new model of disease, healthy young adults will be given lipopolysaccharide     (LPS) to induce endotoxemia and inflammation/fever and then fast and bedrest for 36 hours.     Glucose, fat and protein metabolism will be investigated using clamp technique and tracer     methodology together with intracellular signalling pathway activation in muscle and fat     biopsies. This new model of disease will later be used in another study to investigate     different protein supplement´s effect on muscle waste during acute febrile disease.   "
9724|NCT03158662|"     This survey intends to collect information on key aspects of life with epidermolysis bullosa     (EB), including diagnostic journey, treatment, management, daily living challenges, and     overall psycho-social, socio-economic, academic and family impact.      Objectives:        -  To understand the unmet needs for people living with EB in the US        -  To assess the differences/similarities in the management/treatment of EB patients          (including wound care, symptom management and other issues)        -  To assess the EB patients' and caregivers' perceptions of current management/treatment        -  To assess the challenges and the burden of daily living with EB        -  To understand EB diagnostic journey (the time to diagnosis and by what type of          healthcare provider)        -  To identify professional disciplines involved in the diagnosis and management of EB        -  To understand the psycho-social, socio-economic, academic, and family impact of EB   "
9725|NCT03158649|"     The identification and treatment of the disorders connected to the perinatal period has     traditionally catalyzed the researchers' attention. Nevertheless, since the World Health     Organization has recently coined the concept of positive pregnancy experience, which includes     not only treatment of diseases, but also health education, and health promotion, research on     antenatal care has expanded to a salutogenic perspective. In the wake of this perspective, a     growing number of research have been examining the potential benefits of positive aspects and     protective factors on maternal prenatal well-bein. This salutogenic perspective is supported     by the emerging field of Positive Psychology. Evidence from Positive Psychology studies has     shown that it is possible to build and enhance personal strengths, sense of meaning and     positive feelings by practicing some brief positive exercises, called Positive Psychology     Interventions (PPIs). Recently, researchers have started to investigate the effects of a PPI     on women's prenatal well-being, reporting promising findings in terms of potential direct     effects of the positive intervention on women's prenatal stress in comparison to a     treatment-as-usual control condition. In the past decade, many web-based delivered     interventions have been designed and documented to be effective for the promotion of mental     health and for the prevention and treatment of different disorders. Indeed, recent systematic     reviews provides preliminary evidence that web-based interventions can be a promising and     advisable form of intervention during the perinatal period. PPIs have been translated also in     the online format. Preliminary evidence suggests that online positive psychology     interventions can effectively enhance well-being and reduce depressive symptoms.      The research team have developed the protocol for a web-based positive psychology programme     addressed to promote and enhance women's prenatal well-being. This intervention programme     will last five weeks and will be completely self-administered. It is intend to study the     effect of the intervention on levels of mental well-being, depression, pregnancy related     anxiety and other relevant variables, and the results will be compared to a waiting list     control group.   "
9726|NCT03158636|"     The era of precision medicine is an exciting time for clinicians, scientists and patients     alike. The increasing appreciation and identification of specific mutations that drive     cancers, leaves us on the threshold of a new era in which biomarkers will be used to direct     targeted agents to only those patients most likely to respond. The potential medical and     scientific benefits of such a personalised approach to cancer therapy are immense. However, a     number of barriers challenge successful implementation of this approach of which spatial and     temporal heterogeneity are a major concern.      Gynaecological cancers are a major cause of mortality and morbidity internationally. In     Auckland 150 new patients with ovarian, endometrial or cervical cancer are seen by a medical     oncologist each year. In general, when these diseases recur, there are few effective     therapeutic options and prognosis is poor. Better therapeutic targets and treatments are an     unmet need across these tumour types with treatment paradigms still based upon platinum based     therapy.      PROSPER (Profiling of Oncology Patients as part of Clinical care and Research) will     investigate the evolution of gynaecological cancers over time and in response to treatment to     develop better biomarkers to guide treatment decisions and ultimately improve patient     outcomes. Biopsies at relapse will be collected and profiled with a 580 cancer gene panel.     Circulating tumour DNA will be collected and analysed alongside biopsies as a potential     non-invasive alternative. Linking genomic and clinical data will allow us to learn more to     begin to change our paradigm of care.   "
9727|NCT03158623|"     3 cohorts of total joint patient of 30 members each were randomized to receive PRP or     Activated Collegen or no additive were studied for status of the wound at 6 weeks and     recorded all complications, infections and reoperations. The three groups were than compared     for statistical analysis   "
9728|NCT03158610|"     Based upon biological behavior, those mCRC patients who respond well (SD, PR or CR according     to RECIST Criteria) after 16-18 weeks of standard doublet chemotherapy as induction may     enrolled into this study, randomly divided into capecitabine metronomic group or standard     dosage group. The duration of disease control after randomization(PFS2) and progression free     survival from enrollment (PFS1) are primary endpoints. Meanwhile, the overall survival,     safety and quality of life are secondary endpoints. Exploratory markers involving     angiogenesis (serum VEGF, PDGF, Tie-1 and Tie2, etc) and immune function (CD clusters, serum     tumor mutation burden(TMB), etc), are conducted via liquid biopsy.   "
9729|NCT03158597|"     This study aims to compare whole-blood microarray gene-expression profiling between patients     with acute myocardial infarction and normal participants without cardiovascular diseases.     Firstly, screening differentially genes of mRNA to perform gene ontology and pathway     analysis. Secondly, predicting target genes regulated by microRNA and constructing     coexpression network with mRNA. Thirdly, biological function experiment of microRNA. Finally,     revealing pathogenic mechanisms associated with acute myocardial infarction.   "
9730|NCT03158584|"     safety and efficacy of intrathecal morphine in post operative pain relief in pediatric     patients undergoing major abdominal cancer surgeries using different doses of intrathecal     morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).   "
9742|NCT03158428|"     This study will evaluate exposure to tobacco constituents from two moist snuff products, and     provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of     each of the two moist snuff products.   "
9743|NCT03158415|"     The purpose of this mixed-methods study is to explore the lived experience of parents of     young adults ages 18 to 25 years with type 1 diabetes who are transitioning to independence,     and to test the preliminary efficacy of a mobile education program to reduce parental     distress.   "
9744|NCT03158402|"     This study evaluates the impact of preoperative high-intensity inspiratory muscle training     (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will     receive high intensity inspiratory muscle training and the others a sham inspiratory muscle     therapy.   "
9745|NCT03158389|"     The objective of N2M2 is the improvement of overall survival of patients with glioblastoma     with an unmethylated MGMT promoter based on molecular characterization and use of targeted     compounds in a modern trial design. The progression-free survival rate at six months (PFS-6)     will be used to make decisions.   "
9746|NCT03158376|"     To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic     pain after thoracotomy.   "
9731|NCT03158571|"     Background. Gastric cancer (GC) is the world's second leading cause of neoplastic mortality.     Genetic alterations, response to treatments and mortality rates are highly heterogeneous     across different regions. In Chile, GC is the leading cause of cancer death, affecting 20 per     100,000 people and >3,000 deaths/year. Clinical outcomes and response to one size fits all     therapies are highly heterogeneous and thus a better stratification of patients may aid     cancer treatment and response.      Study design/methods. The Gastric Cancer Task Force (GCTF) is a Chilean collaborative,     non-interventional retrospective study that seeks to stratify gastric adenocarcinomas (GACs)     using retrospect clinical outcomes and genomic, epigenomic and protein alterations in a     cohort of 200 patients. Tumor samples from the pathology department and the Cancer Center at     UC Christus healthcare network at Pontificia Universidad Católica de Chile will be analyzed     using a panel of 143 known cancer genes (Oncomine Comprehensive Assay) at the Center of     Excellence of Precision Medicine (CEMP) in Santiago, Chile. Additionally, gene promoter     methylation will be performed and selected clinically relevant proteins (e.g. PD-L1, Erb-2,     VEGFR2 among others) will be assessed by Tissue Microarray, Epstein-Barr virus (EBV) status     will also be assessed. Observations will be correlated to 120 clinical parameters, including     general patient information, cancer history, laboratory studies, comorbidity index,     chemotherapy, targeted therapies, efficacy and follow-up.      Discussion. The development of a clinically meaningful classification that encompasses     comprehensive clinical and molecular parameters may improve patient treatment, predict     clinical outcomes, aid patient selection for clinical trials and offer insights into future     preventive and/or therapeutic strategies.   "
9732|NCT03158558|"     The purpose of this study is to test an intensive, multi-couple group version of a couple     therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their     romantic partners in a single weekend retreat. The study will be conducted on or near Fort     Hood in Kileen, Texas. Twenty-four couples will be treated with this therapy and assessed     immediately before treatment, 1 month after treatment, and 3 months after treatment.   "
9733|NCT03158545|"     The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3     polyunsaturated fatty acid dietary supplements on cerebral blood flow during a series of     cognitive, mathematical subtraction tasks and subjective ratings of task difficulty before     and after 26 weeks of supplementation   "
9734|NCT03158532|"     The radial approach for a coronary angiography has became popular in several centers because     of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main     inconvenient and impose a limitation of future use of the radial artery as an access site for     catheterization in the future. Several strategies have been used to decrease the incidence of     RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in     prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of     the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the     start of catheterization would have the same effect was not tested.   "
9735|NCT03158519|"     The purpose of this study is to test the mechanics and feasibility of delivering an     individualized intervention to increase physical activity in breast cancer survivors.      In this study, researchers will test an intervention that uses a commonly worn activity     monitor (i.e., global positioning system [GPS] enabled running watch) to see if they can     prescribe specific ways to increase physical activity that are individually tailored to     each participant. The goal is to help participants increase their daily physical activity     without having to join a gym or other traditional fitness program. Researchers want to see if     they can make specific recommendations (using an application that can be added to a cell     phone, tablet and/or computer) on ways participants can slowly increase their activity based     upon where they live and work and in a way that is tailored individually to them. For     example, participants may be given a route to walk on their lunch break, or new place to park     to allow for a longer walk to their job. The goal is to meet participants where they are in     their current level of fitness, and to help them think of new and creative ways of increasing     activity without the frustration of soreness or risk of injury. As they move more, the     recommendations will increase with them.   "
9736|NCT03158506|"     This is an open-label, single center, 1-period study in healthy adult male subjects to assess     absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg     (90 μCi) of [14C]-HMS5552.   "
9737|NCT03158493|"     Recently, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive     Care Medicine (ESICM) have published new definitions of sepsis, known as Sepsis 3, based on a     fairly robust analysis of large, essentially American, databases. In addition to the new     definition, a new screening score was suggested, named quickSOFA (qSOFA). This score is     positive if two of three variables are present: respiratory rate higher than 22 ipm, reduced     level of consciousness and systolic blood pressure lower than 100 mmHg. Although the receiver     operator characteristics (ROC) curves suggest an adequate predictive validity for the new     score, a lot of controversy around its sensitivity as a screening tool mainly in settings     with high mortality rates. Current national Brazilian data show that sepsis mortality in our     country, especially in public hospitals from the Unified Health System (SUS), is very high     and well above world mortality. The impact of using the qSOFA in these settings is not known.     In this context, the present study aims to evaluate the potential impact of using qSOFA as a     screening tool in Brazilian private and public institutions. The hypothesis is that the use     of qSOFA as a screening tool will have a low sensitivity. As a consequence, patients with the     diagnosis of sepsis, with organ dysfunction, will not be detected by this tool. The     hypothesis was also that those patients with a qSOFA negative will have a high mortality     rate, mainly in Brazilian public hospitals.   "
9738|NCT03158480|"     Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells     (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using     interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata     patients only use interferon.   "
9739|NCT03158467|"     We aim to examine the effect of an online advance directive on decisional conflict and     quality of life in patients undergoing stem cell transplant. We also aim to assess the effect     of palliative care at the time of a sentinel event on quality of life.   "
18388|NCT03044860|"     Investigation of the anatomical distribution of enteroendocrine cells by a systematic     approach along the entire human intestinal tract in healthy individuals and patients with     type 2 diabetes.   "
9748|NCT03158350|"     Toothbrush plaque removal, along with interproximal flossing, helps to maintain the oral     cavity free from periodontal diseases and dental caries. Although techniques such as the Bass     Technique (BT), the Modified Bass Technique (MBT) and the Modified Stillman Technique (MST)     are taught to dental students, dental hygiene students, and dental assistants, there is     little evidence to discern which technique is more effective in reducing or preventing     gingival inflammation.      At Tufts University School of Dental Medicine (TUSDM), a modification of the Bass     intrasulcular technique is advocated to many students. We call this modification of the Bass     technique a Stationary Bristle Technique (SBT), which is an intrasulcular technique that     maintains the toothbrush bristle ends essentially stationary on the tooth cervically and in     the gingival crevice.      In this study, half of the participants were taught the Stationary Bristle Technique Group,     while the other half were not be provided with instructions, but asked to brush as normal     (non-interventional group) throughout the duration of the study.   "
9749|NCT03158337|"     While it is well established that physical inactivity is a modifiable risk factor for     vascular disease and cognitive decline, the mechanism by which exercise exerts its protective     effect on the cerebral circulation and cognition is unknown. This knowledge gap was     recognized recently in the Centers for Disease Control & Prevention and the Alzheimer's     Association document National Public Health Road Map to Maintaining Cognitive Health. Our     rationale for these studies is that the identification of physical exercise as a lifestyle     factor able to improve cerebrovascular reserve and cognition would establish a strong     scientific framework justifying design of a randomized clinical trial that could evaluate the     role of physical activity in cerebrovascular health and function.      This research is based on data we obtained from a cross-sectional study that showed     significant relations between physical fitness, vascular regulation and cognition.     Cerebrovascular reserve and cognition were better maintained in women who were physically     active but reduced in women who were sedentary. Our central hypothesis is that regular     aerobic exercise mitigates age-related decreases in cerebrovascular reserve, which in turn     imparts benefits in cognition. Further, we believe that these effects will persist after the     structured aerobic exercise program is terminated.      Our 18 month study began with a 6-month baseline period, followed by a 6-month exercise     intervention, and a 6-month follow-up period. In addition, there are 5-year and 10-year     follow-up periods. Volunteers (men and women aged ≥ 55 years) from the community were     recruited using a variety of recruitment methods including media and distribution lists.     After the baseline (pre-training) measurements, participants underwent a six-month aerobic     training program, following guidelines previously used by us and according to the new     exercise guidelines for older adults established by American College of Sports Medicine and     the American Heart Association. The study involves comprehensive assessments of physical     fitness, cerebrovascular responses to carbon dioxide at rest and during sub-maximal exercise,     and an extensive battery of cognitive function tests.   "
9750|NCT03158324|"     This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in patients     with advanced, treatment refractory cancers who have biopsy-amenable lesions at study entry.   "
9751|NCT03158311|"     The purpose of this trial is to demonstrate that the efficacy of two treatment arms of the     fixed-dose combination product QVM149 is similar to the efficacy of the free combination arm     of salmeterol/ fluticasone+ tiotropium in uncontrolled asthmatics.   "
9752|NCT03158298|"     The study intends to examine the association between schistosomiasis seropositivity and     adverse pregnancy outcomes.      It aims at the verification of the hypothesis that in pregnant women originating from endemic     areas for schistosomiasis, positive serology is associated with reduced Infant birth weight.   "
9753|NCT03158285|"     The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in     participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and     symptoms of PsA.   "
9754|NCT03158272|"     The purpose of this study is to determine whether an investigational immuno-therapy,     cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of     advanced malignancies.   "
9755|NCT03158259|"     The objective of this study is to investigate the effectiveness of prehospital diagnosis and,     when appropriate, of intravenous thrombolytic treatment of ischemic stroke. At the same time,     we will take the opportunity to do an explorative study with the aim to further improve the     intervention by biomarkers, and outcome measures volumetric measured by MRI images.      The intervention study aim to:        -  Determine the time from symptom onset to thrombolytic treatment in the Mobila Stroke          Unit (MSU) compared to the conventional model        -  Determine the number of patients receiving thrombolytic treatment within the 4.5 hrs          window in the MSU compared to the conventional model        -  Determine if thrombolytic treatment in the MSU, when adjusted for time, results in          better mRS- and Barthel outcome compared to treatment in the conventional model The          explorative study aim to        -  Determine if final IS infarction volume estimated by MRI, is independently correlated          with time from symptom onset to thrombolytic treatment        -  Define cut-off values for GFAP and RBP4 combined that with sufficient specificity and          sensitivity can distinguish ICH from IS        -  Determine the influence of time to treatment on pro-inflammatory markers after stroke      Hypothesis Intervention study I. The Treat - NASPP MSU model is feasible and reduces onset to     treatment time less than 15 min II. The number of patient treated with thrombolysis within     4.5 hrs of symptom onset is significantly increased in the Treat-NASPP MSU model III.     Treatment in the Treat-NASPP MSU model does not result in increased day 90 mRS and Barthel as     compared to the conventional model when adjusted for time IV. Prehospital thrombolytic     treatment of stroke does not increase the risk of secondary cerebral bleeding as compared to     in-hospital thrombolytic treatment of stroke (cerebral bleeding worsening within 36 hrs less     than 4 per cent, Norsk hjerneslagregister) Explorative study V. The final infarct volume,     estimated by MRI, is significantly reduced when thrombolytic treatment is initiated already     in the MSU VI. Biomarkers is a valid tool in the hyper acute phase of cerebral illness to     exclude contraindication to thrombolysis VII. Reduced onset to treatment time results in     lower levels of selected pro-inflammatory molecules   "
9756|NCT03158246|"     This study compares the efficacy and safety of generic zoledronic acid (Yigu®) and original     zoledronic acid (Aclasta®) in the treatment of postmenopausal osteoporotic women in China.     Four hundred and sixty-six subjects will be randomised (1:1ratio) to either Yigu® 5mg IV or     Aclasta® 5mg IV treatment arms.   "
9757|NCT03158233|"     This prospective, surveillance study will assess the operational Zika virus definition for     use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to     identify Zika virus disease (ZVD) cases among the study cohort.   "
9758|NCT03158220|"     This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 27- to     45-year-old women, and will complete the evaluation of GARDASIL®9 in the extended age range     of female participants for whom GARDASIL® was proven to be effective. The primary hypothesis     of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 titers at 4 weeks postdose 3     are non-inferior in adult women as compared with titers in young adult women.   "
11190|NCT03139435|"     This pilot clinical trial studies how well ultrasound works in detecting taxane-induced     neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and     detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a     taxane.   "
9798|NCT03157700|"     This Phase II STTR will evaluate an interactive, self-paced, e-learning media literacy     intervention, REAL media, to prevent youth substance use among youth in the 4-H organization.     Participating 4-H clubs will be randomly assigned to use the curriculum or continue current     practices with the option for delivery at the end of the study. 4-H members (ages 13-15) will     complete a pretest, immediate posttest and follow-up posttests at 3 and 9 months to assess     effects.   "
33106|NCT02852434|"     This study seeks to compare self-administered lidocaine gel for pain control during cervical     preparation for dilation and evacuation (D&E) to paracervical block.   "
9759|NCT03158207|"     Positive pressure ventilation can be life saving for patients who are hypoxic, hypercapneic     or apneic. Manual ventilation with a facemask is a skill that is routinely required for     emergency medical technicians, respiratory therapists, nurses and physicians. Although mask     ventilation skills are routinely taught, even the most skilled and experienced     anesthesiologists struggle to effectively mask-ventilate.      The effective use of a standard mask requires the simultaneous establishment of a seal     between the mask and face and the lifting of the jaw. The preferred grip is referred to as     the C&E technique. The C&E technique requires the index finger and thumb to form a C and     push down on the mask to establish a seal between the mask and face. The lateral three     fingers form the E and wrap under the jaw to provide lift. The grip required to establish     the seal and jaw lift simultaneously is awkward and difficult to teach. The basic design of     the standard facemask has not changed in approximately 100 years.      This study will evaluate a new mask design, Warters Mask, is based on a novel design that     allows a far more ergonomic grip. The C&E technique is replaced by a more natural grip. With     the Warters Mask, downward pressure with the palm of the hand centered on the mask provides     the seal between the face and the mask. The other four fingers align under the jaw to provide     lift.   "
9760|NCT03158194|"     This is a study to develop a protocol on Cognitive behavior therapy (CBT) for asthma-related     anxiety that in a consecutive study can be translated to internet-delivered CBT.   "
9761|NCT03158181|"     The aim of this interventional study is to optimize the movements and discipline of surgical     staff in order to improve the quality of care, the safety of the patient in the surgery and     to prevent the postoperative complications in the broad sense and in particular the infection     of the surgical site. The intervention will be carried out using tools of new technologies     allowing the monitoring of the movements and the sound level associated with techniques of     behavior change inspired by those used in the human and social sciences.   "
9762|NCT03158168|"     Warts are common and infectious viral diseases of the skin and are prevalent worldwide. Warts     are caused by the human papilloma virus (HPV), which has more than 100 strains; some of them     are known to be premalignant .Although warts can appear at any age, they are more common in     children and adolescents. The prognosis of warts cannot be predicted. In some patients they     may spontaneously disappear, whereas others show persistence and progression with spreading     to other body sites, leading to physical and emotional distress to the patients. [ 1 ].   "
9763|NCT03158155|"     To detect the effect of vitamin D deficiency in the development of early childhood caries     (ECC) among Egyptian children.   "
9764|NCT03158142|"     Atropine eye drops are increasingly prescribed for the management of progressive myopia or     short-sightedness. A previous study suggested that the back of the eye or choroid may be a     part of the mechanism by which it induces its effects.      The aim of this study is to characterize the effects of atropine on choroidal thickness and     the influence of time of administration (am vs pm). It is hypothesized that the atropine's     effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm,     where thicker baseline thickness will show a reduced choroidal response.   "
9765|NCT03158129|"     The goal of this clinical research study is to compare nivolumab alone to nivolumab plus     ipilimumab when given to patients with non-small cell lung cancer (NSCLC) that can be     surgically treated.      Researchers want to learn how effective both study treatments may be in helping to control     NSCLC after surgery.   "
9766|NCT03158116|"     This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in     pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa. The aim of     the study is to see if AZLI being taken in a one month on / one month off cycle over the     course of a year can decrease the need for systemic antibiotics and/or hospitalizations.   "
9767|NCT03158103|"     The purpose of this study is to test the safety and tolerability of the combination of     pexidartinib and MEK162. This study tests different doses of pexidartinib in combination with     different doses of MEK162 to see which dose combination of these drugs is safe and best     tolerated in people.   "
9768|NCT03158090|"     This study is a prospective, noninteractive, observational, and longitudinal study aimed at     assessing the treatment pattern and clinical outcome of acromegaly in China.   "
9769|NCT03158077|"     Retrospective observational study, multicentric with Spanish hospitals, in which a switching     or change strategy with RAL and ABC / 3TC guidelines was used, in the48 weeks before the     start of the study, in order to determine parameters of Effectiveness and security.   "
9770|NCT03158064|"     The purpose of this study is to test the safety and effectiveness of durvalumab with     tremelimumab in patients with relapsed or refractory germ cell tumors.   "
9771|NCT03158051|"     This is a 5-year randomized controlled trial in two large healthcare systems (Madison and     Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact     on blood pressure among 310 geographically and racially/ethnically diverse young adults.   "
9772|NCT03158038|"     This prospective annual release study is designed to evaluate the safety of 1 new influenza     virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza     season.   "
9773|NCT03158025|"     The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006)     in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and     suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action     (suvorexant).   "
9782|NCT03157908|"     Population mobility is frequent in South Africa and disrupts the continuity of HIV care.     Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are     highly mobile. This pilot study aims to engage peripartum, HIV-positive women as potential     users to evaluate a novel smartphone application to assist these women with linkage to new     HIV facilities and prospectively describe the mobility of this population.   "
9783|NCT03157895|"     This study evaluates the efficacy of a self-directed parenting program called Connecting in     reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15).     Half of the participants will receive services as usual from the foster system, while half     will participate in the Connecting program. Connecting is a 10-week, self-directed parenting     workbook with two digital video discs (DVDs). Families receive weekly telephone support as     they complete the program.   "
9784|NCT03157882|"     To examine pediatric pain assessment in the Emergency Department   "
9774|NCT03158012|"     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of     S. aureus skin infections. In addition, research in the investigator's lab has shown that     these patients have fewer protective antimicrobial Staphylococcal species such as     Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides     that play a role in protecting the skin from invading pathogens. In this study, the     investigator will attempt to decrease S. aureus colonization and increase colonization of     protective Staph species in AD patients. First the investigator will capture the bacteria on     subjects' skin. Next the investigator will selectively grow the subject's antimicrobial     Staphylococcal colonies and place them into a base moisturizer. The moisturizer plus bacteria     will be applied to one of the subject's arms for one week. Some subjects will receive     placebo, which is the moisturizer alone (without bacteria). The investigator will then swab     the arms at specified time points during and after the one week application in order to     determine whether the S. aureus abundance was affected by the application of the transplanted     bacteria.   "
9775|NCT03157999|"     The aim of this study is to test a support program for older adults with symptoms of     depression and other chronic health problems after they are discharged home from hospital.     The study will be conducted in three communities in Ontario (Sudbury, Burlington, and     Hamilton) and the program will be implemented with input from community members. The program     will be delivered by a Registered Nurse, who will provide support to patients via home visits     and telephone calls. The nurse's role will involve linking patients and their caregivers with     needed services and supports, reviewing medications that the patients are taking, assessing     patients' health, building the skills of patients in problem-solving and managing their care,     and providing education to patients and their caregivers.   "
9776|NCT03157986|"     Aim of this study is to compare the effects of whole-body Vibration Training versus     conventional Balance Training on Balance performance, gait quality and exercise capacity in     patients with severe chronic obstructive pulmonary disease. Patients will be recruited during     a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two     intervention groups. On top of a standardized endurance and strength Training program (5 days     per week) patients in both groups will perform an additional Balance Training (on 3 days per     week). Patients in both Groups will perform the same 4 different Balance exercises (2x1     Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg     stance but on a different surface. The Vibration Training Group will perform the exercises on     a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the     control Group will perform exercises on instable objects like Balance pads. The degree of     difficulty in both Groups will be individually adjusted and will be progressively increased,     if possible.   "
9777|NCT03157973|"     This study evaluates the effects of an eHealth tool and psychosocial support on anxiety,     depression and health-related quality of life in patients undergoing surgical treatment for     abdominal aortic aneurysm (AAA). Participants in the intervention group will receive access     to the eHealth tool and structured follow-up with a contact nurse, the control group will     receive standard of care.   "
9778|NCT03157960|"     The metabolism of the monosaccharide fructose is less controlled than the metabolism of     glucose, which will result in the metabolic product uric acid. Elevated serum uric acid     levels are associated with increased risk, or worsening, of chronic kidney disease. The     mechanisms by which uric acid have detrimental effects are not well defined, but may include     an increase in reactive oxygen species and subsequent inflammatory activity. The aim of this     study is to investigate the effects of uric acid, markers of oxidative stress and markers of     inflammation following a low fructose load reflecting normal conditions. This is an     interventional study. On six different occasions patients with chronic kidney disease,     patients with type 2 diabetes and healthy controls will receive Blueberry drink, Coca-Cola or     pure Fructose drink with similar amount of carbohydrates (140 kcal) with and without a high     fat meal represented by a pizza (425 kcal).Serum samples and urinary samples will be     collected.   "
9779|NCT03157947|"     A pilot study testing the effect of an in-visit English and Spanish language decision aid for     Hispanic-Latino men using best practices of cultural tailoring to be used in urology     practice. Subjects will be followed for approximately 1 year during standard care in-clinic     office visits. Study results and subject surveys will be analyzed to determine clinical     utility of the tool.   "
9780|NCT03157934|"     FAST is an investigator-initiated multicenter study embedded in a German multistate acute     stroke network. The main objectives of the FAST study are to improve outcomes and quality of     care for stroke patients, to quantify the number of patients in need of thrombectomy within     an integrated stroke network, to study the best way of delivering and performing thrombectomy     and to investigate the best model of pre-hospital selection and referral for stroke patients.   "
9781|NCT03157921|"     Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age,     with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to     Rotterdam criteria by at least two of the following three key features: oligomenorrhea or     amenorrhea; clinical and/or biochemical signs of hyperandrogenism; the presence of polycystic     ovaries on ultrasound and exclusion of other endocrine disorders including     hyperprolactinemia, thyroid dysfunction and congenital adrenal hyperplasia. Polycystic ovary     syndrome is also associated with insulin resistance, obesity and disorders of lipid     metabolism, as well as infertility, although these findings have not been addressed in the     Rotterdam criteria. Polycystic ovary syndrome is the major cause of anovulatory infertility.     The recent studies suggest that anovulation resulting from ovarian follicle abnormalities in     Polycystic ovary syndrome patients are 2-fold of normal ovaries. Firstly, early follicular     growth is excessive, thus women with Polycystic ovary syndrome are characterized by an     excessive number of small antral follicles (2- to 3-fold of normal ovaries). Secondly, the     selection of one follicle from the increased pool of selectable follicles and its further     maturation to a dominant follicle does not occur. This second abnormality in the     folliculogenesis can cause menstrual dysfunction presented as oligomenorrhea or amenorrhea.     Historically, Polycystic ovary syndrome treatment has not been curative in nature, instead     treatments focus on resolution of clinical manifestations of the disease.   "
9817|NCT03156413|"     This investigation is designed to evaluate the performance as well as the patients overall     acceptance of the mask.   "
9785|NCT03157869|"     Motor learning occurs with structural and functional modifications in neural networks that     meet a certain demand. The improvement of performance in diverse activities is a measure of     learning, as well as the generalization and transference of this capacity. Transcranial     direct current stimulation (tDCS) is a modulation technique of brain activity that modifies     cortical excitability, causing changes in motor evoked potentials that influence motor     learning. Modifications similar to the long-term potentiation, essential for learning     processes, have also been described after applying tDCS. The primary motor cortex is the area     of stimulation where there is more robust evidence in favor of increased motor learning.     PURPOSE: to investigate the effects of anodic tDCS on the learning of sequential finger     movements in young and healthy individuals.   "
9786|NCT03157856|"     In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect     post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the     feasibility and detection of anti-PSMA labelling by:        1. / the FEMTO-ST institute medical device,        2. / the confocal microscope that will be used to measure fluorescence spectra of          biological samples.   "
9787|NCT03157843|"     After reports from observational studies suggesting an association between acutely ill     medical patients and venous thromboembolism (VTE), interventional trials with anticoagulants     drugs have demonstrated a significant reduction of VTE during and immediately after     hospitalisation. Although several guidelines suggest the clinical relevance of reducing this     outcome, there is a low tendency to use anticoagulants in patients hospitalised for acute     medical illness. This observational multicentre study wants to evaluate the incidence of     venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.   "
9788|NCT03157830|"     The primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in     Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ)     by evaluating relapse rate, progression on MRI and disability progression.   "
9790|NCT03157804|"     This is an open, Phase I / II clinical trial to evaluate the safety and efficacy of a     hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector     carrying the FANCA gene for patients with Fanconi Anemia of Subtype A .      CD34 + cells derived from bone marrow and / or mobilized peripheral blood (fresh and / or     cryopreserved) from patients with Fanconi subtype A (FA-A), will be transduced ex vivo with a     lentiviral vector carrying the gene FANCA (orphan drug) . After transduction the cells will     be inoculated in patients in order to restore their hematopoiesis with genetically corrected     stem cells.   "
9791|NCT03157791|"     This Clinical Trial is being conducted to study the effect of oral simethicone on the     presence of bubbles during colonoscopy. The purpose of this study is to find out what effects     (good and bad) the addition of oral simethicone to bowel preparation has on the ability to     visualize the colon mucosa (bowel) during colonoscopy.   "
9792|NCT03157778|"     Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions     and over a meal in obese and normal-weight men subjects, to research a dysfunction in the     negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction     could participate to the hyperactivity of endocannabinoid system saw in obesity.   "
9793|NCT03157765|"     Patients with a history of recurrent implantation failure who are planning a frozen embryo     transfer (FET) are enrolled into the program. Patients are randomized to an endometrial     biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or     to routine care.   "
9794|NCT03157752|"     In France, screening involves a routine test of papanicolaou in women aged 25 to 65 years. In     the case of an abnormal Pap smear discovery, the diagnostic strategy is based in most cases     in colscopy to allow cervical biopsies if necessary to obtain a histological diagnosis of     high quality cervical intraepithelial neoplasia (CIN) (2- 3) which, if persistent, can cause     cervical cancer. Their results, also in the case of the persistence of a low-level lesion or     of a cyto-histological discordance, indicate conization. Conization is a procedure performed     by resection of the diathermic grip, allowing a simple and fast gesture compatible with a     load under local anesthesia. In order to simplify the overall cost of the patient, more and     more conizations of Montpellier and Nimes take place under local anesthesia. .      The main objective of our study is to evaluate the overall satisfaction of patients in the     case of conisation under local anesthesia.      The goal is to promote local anesthesia for the management of congested patients, which     simplifies overall management, reduces cost and reduces complications associated with general     anesthesia.   "
9795|NCT03157739|"     The purpose of the study is to develop, evaluate, and optimize MigraineManager, the first     web-based comprehensive self-management tool for adolescents with migraine, their parents,     and clinicians.   "
9796|NCT03157726|"     The study is a multicentric randomized control trial with 4-year follow-up comparing     perioperative and postoperative outcomes for transurethral plasmakinetic enucleation of     prostate(TUKEP) and transurethral resection of prostate(TURP). The investigators recruit     patient with benign prostatic hyperplasia(BPH) as the object of study. TURP is set as control     group . Meanwhile TUKEP is set as test group. Six affiliated hospitals will participate in     this study. Through analyzing the perioperative and postoperative data between TUKEP group     and TURP group, The investigators purpose demonstrating superiority of safety, efficacy and     economic benefit in TUKEP group.   "
9797|NCT03157713|"     Financial incentives for motivating changes in health behavior, particularly for weight loss     in obese individuals, are increasingly being tested by health insurers, employers, and     government agencies. However, a key unanswered question regarding weight loss is how to     structure these incentive programs to maximize their effectiveness, acceptability to     patients, and economic sustainability. Focusing on obese patients living in neighborhoods     with a high concentration of low socioeconomic status households, the investigators will     compare the impact of financial incentives for weight loss on sustained weight loss, use of     evidenced-based therapy, and quality of life, and they will determine their short-term and     long-term return on investment.   "
9952|NCT03155672|"     To gain understanding about the impact of visual art making on biomarkers, such as cortisol,     alpha amylase, oxytocin, etc. to examine whether and to what extent there are changes in     levels of stress and immune function in patients and caregivers adults (including family     caregivers and medical professionals)   "
9799|NCT03157687|"     This study should reveal differences in composition of luminal and mucosa-associated     microbiome of the human gastrointestinal tract.Therefore bacterial species of different     intestinal location sites (small intestine and colon) isolated of biopsies were compared to     bacterial composition of stool samples. Additionally the bacterial composition of healthy     persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis)     will be compared to detect influence of local and systemic inflammation on microbiome.   "
9800|NCT03157674|"     This study will be focused on HNC patients who have been diagnosed with HNC between     01-Jan-2013 and 30-Sep-2016.   "
9801|NCT03157661|"     Hypertension is a major medical and public health burden throughout the world. It is     estimated that 1 in 3 adult South Africans are diagnosed with hypertension, however detailed     statistics reflecting the burden of disease are somewhat lacking. The implications and     effects of poorly controlled hypertension and its associated co-morbidities are significant     and extensive. In South Africa, hypertension is the single most prevalent cardiovascular risk     factor and predominant contributor to cardiovascular disease and mortality.   "
9802|NCT03157648|"     Shivering is a physiologic response to early hypothermia in mammals. The definition of     shivering is an involuntary, oscillatory muscular activity that augments metabolic heat     production.      Routinely in post anesthetic care unit (PACU), the core temperature via tympanic membrane is     always measured in all patients. Sometimes patients who have low temperature have no     shivering symptom in other hand patients who have normal temperature have shivering symptom.     This indicates that, only core temperature is not enough for predicting or detecting patients     who will have shivering symptom in PACU.      In this study, investigators hypothesise that the core-peripheral temperature difference in     postoperative period indicates patients who will have shivering symptom.      Thus, the aims of this study are to evaluate the relationship between core-peripheral     temperature difference and shivering symptom in patients in PACU.   "
9804|NCT03157622|"     Exploration of treatment processes during exposure and cognitive-behavioral therapy in the     context of chronic low back pain in a multiple baseline single-case design.   "
9805|NCT03157609|"     The present study aims to assess the accuracy of the SpotOn™ Zero-heat-flux-thermometry     sensor in measuring core temperature in the paediatric population in the perioperative     period.   "
9806|NCT03157596|"     Considering the impact of caregivers' oral health knowledge, attitudes and practices on the     oral health of their children; we introduced an educational program to the parents and     caregivers of children with developmental disabilities about the oral healthcare of their     developmentally disabled children to rise up with the oral health status of those children.   "
9807|NCT03157583|"     The purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations     using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.   "
9808|NCT03157570|"     Studies with exercise intervention aimed to improve the bone health and muscle functions in     patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass     were associated with curve severity and occurrence of AIS. Weight-bearing exercise that aimed     to improve musculoskeletal and metabolic health could enhance bone health and muscle mass,     and could provide a feasible alternative conservative treatment to prevent curve progression     as well as the quality of life in AIS girls. This is a pilot feasibility study for future     large randomized controlled trial (RCT) aiming at determining the effects of home based     exercise program on improving bone mineral density (BMD), muscle mass and functions, quality     of life (QoL), and prevent curve progression in skeletally immature girls with adolescent     idiopathic scoliosis (AIS).   "
9809|NCT03157557|"     Introduction and rationale:      Unhealthy eating habits and lack of physical activity are risk factors for many diseases     (including metabolic syndrome) and contribute to a shortened lifespan of 15-30 years in     people with severe mental illness (SMI). Literature, mainly including short-term hospitalized     or outpatients, show strong positive effects of activation on both physical and mental     health. However, studies in long-term care are limited. In recent years, implementation of a     lifestyle enhancing treatment intervention in clinical settings in GGz Centraal has     demonstrated to be effective. The question is whether this kind of lifestyle intervention in     sheltered housing is applicable and effective.      Objectives:      This research aims to develop an appropriate lifestyle intervention for patients living in     sheltered housing services of GGz Centraal, based on input of patients and directly involved.     Does applying this lifestyle treatment result in a positive effect in health and quality of     life of patients and what is the influence of contextual factors, personal- and disease     characteristics?      Study design:      In this intervention study, we use an experimental design. Municipal locations are paired     based on the number of participants to generate equal cluster sizes. These paired clusters     are randomly allocated to the control or intervention arm by means of a random number     generator by an independent person (not involved in this project). At the start of the     lifestyle treatment patients in the experimental and control group are invited to participate     in the baseline screening. After six months, following a post-test on all outcome measures.      Treatment intervention:      The intervention in this study consists of formulating a lifestyle intervention, by patients     and directly involved, aimed at enhancing a more active and healthier lifestyle . After     formulation of the plan (based on psycho education, nutrition and physical activity), it wil     be executed for a six month period.      Hypothesis:      Hypotheses is that lifestyle enhancing treatment is associated with improved metabolic     health, quality of life and reduced use of medication. Furthermore we expect that movement     disorders and disease severity will be negative related in becoming more active.   "
9810|NCT03157544|"     The purpose of this project is to determine the effect of a multimodal non-pharmacological     Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of     individuals suffering from an acute pain episode of chronic neck and/or low back pain over a     3-week duration.   "
9849|NCT03157193|"     The effect of the hyaluronic acid treatment on peri-implantitis has not been tested. The aim     was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and     the expression of biochemical inflammatory markers in the crevicular fluid of implants     receiving perimplantitis treatment.   "
9818|NCT03156400|"     This study will compare examine autonomic and cardiovascular responses to peak exercise     testing in Parkinson's disease patients in varying stages of the disease, and healthy,     age-matched participants. Participants will be asked to complete a peak exercise test on a     motorized treadmill. Heart rate, blood pressure, norepinephrine, and other markers for     cardiovascular function will be assessed at rest, during exercise, and post-exercise. The     hypothesis to be tested is that Parkinson's disease patients will exhibit a decreased     autonomic and cardiovascular response to exercise when compared to patients' healthy     age-matched counterparts. The investigators secondary hypothesis is that Parkinson's disease     patients in more advanced stages will exhibit a greater decrease in response when compared to     these patients' Stage 1 counterparts, or healthy age-matched counterparts.   "
9811|NCT03156491|"     Background of the study:      The etiology of recurrent miscarriage (RM, defined as three or more consecutive miscarriages     without any proven maternal or fetal cause), remains undiagnosed in more than 50% of cases.     In these cases it is generally considered that a disturbance in the normal mother-embryo     interactions is a causal factor. This disturbance may be based on a dysregulation of embryo     invasiveness and/or decidual acceptance (e.g. altered decidualization; endometrial changes in     preparation for the acceptance of a putative pregnancy). Moreover, dysfunctional maternal     immune regulatory natural killer (NK) cells, implicated in tolerance induction and     trophoblast invasion,may also underlie the occurrence of RM. The Selection Failure hypothesis     for RM suggests that super-receptive endometrium (possibly due to increased embryo     invasiveness and/or decidual acceptance and/or dysregulated immune cell function) may allow     'poor quality' embryos to implant and present as a clinical pregnancy before miscarrying.     Fundamental knowledge on mechanisms of embryo implantation, decidual function and maternal     immune reactivity in successful pregnancies has accumulated over the past 5 years. This study     aims to investigate whether dysregulation of (one of) these mechanisms may underlie RM.      Objective of the study:      To test The Selection Failure hypothesis by assessing A) the degree of embryo invasiveness     and decidual acceptance (the quality of decidualization, endometrium-embryo communication and     endometrial stromal cell (ESC) migration) and B) the angiogenic capacity of decidual NK (dNK)     cells, in order to elucidate the pattern of the mother-embryo equilibrium in women with RM.   "
9812|NCT03156478|"     The aim of the Stop Diabetes - Knowledge based solutions (StopDia) consortium project     (University of Eastern Finland, National Institute for Health and Welfare, and Technical     Research Centre of Finland) is to develop and test approaches to identify individuals at     increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy     lifestyle by combining individual and environment level strategies into a dual-process     approach targeting deliberative and automatic processes of behavior. We also aim to identify     barriers and facilitators of adopting a healthy lifestyle in the society, create a model for     the prevention of type 2 diabetes by joint actions of health care, third sector, and other     societal actors, and develop methods to monitor the cost-effectiveness of these actions. We     will carry out a 1-year randomized controlled trial on the effects of among 10 000     individuals aged 18-70 years at increased risk of type 2 diabetes living in Finland. The     participants will be randomized into the control group, the digital lifestyle intervention     group, or the combined digital and face-to-face lifestyle intervention group. The aim of the     interventions is to enhance diet quality, increase physical activity, decrease body weight,     and improve glucose tolerance in individuals at increased risk of type 2 diabetes.   "
9813|NCT03156465|"     The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24     electrode array and one FDA approved standard-length device in the contralateral ear can     provide useful binaural hearing in pediatric subjects who have bilateral severe to profound     hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear     implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that     are apical to the electrode, thus leaving them available for possible future advances in the     field of otolaryngology and hearing devices, such as mammalian hair cell regeneration     techniques or improved implantable hearing devices. Whether or not this group of children     will be able to take advantage of future hair cell regeneration strategies is yet to be     determined and will have to wait for future development. At this time there are no accurate     imaging strategies available to identify preservation of the scala media. Ultra thin micro CT     scanning is in development, however the level of radiation delivery to the subject is too     great to be considered for clinical use. When imaging strategies become available to     determine cellular structure of the inner ear, they will be applied to this group of     subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to     preserve the middle and apical regions of the scala media.   "
9814|NCT03156452|"     This is a study of two treatment pathways [Standard steroid treatment versus combined steroid     and Mycophenolate (MMF)] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). ITP     is an illness that causes bruising and bleeding due to a low platelet count (blood cells     essential for normal clotting). Patients are first given high dose steroids but most suffer     side effects (e.g. difficulty sleeping, weight gain, moods swings, high blood pressure and     diabetes). In addition, the majority of patients become ill again when the steroids are     stopped - only about 20% stay well long term. ITP is relatively rare, non-cancerous in nature     and the rare impact on survival of ITP have prevented it from being a priority for research     funding, with first line treatment being unsatisfactory and unchallenged for decades. This     underestimates the profound adverse impact an ITP diagnosis and its treatment has on     individual patients, many of whom are young.      MMF is often used as the next stage treatment for ITP and it works well. However, it can take     up to 2 months to work during which patients continue to be at risk of bleeding, bruising,     fatigue and usually need more steroids which they find intolerable. They are required to come     to hospital for weekly blood tests and for many this impacts on work. We want to find out     whether it would benefit more patients if everyone takes MMF at diagnosis instead of current     practice (waiting for the illness to come back). We plan to test this by comparing the     current way we treat patients to a new way with patients given MMF right at the start of     their treatment. 120 patients from 20 different hospitals will be asked to take part and half     will be randomly chosen for the new pathway.   "
9815|NCT03156439|"     This study investigates the safety, tolerability, and pharmacokinetics of BIS-001 ER in     healthy volunteers. Subjects will be dosed twice daily, with a dose escalation occurring     every 2-3 days until a maximum dose of 5mg per day is reached.   "
9816|NCT03156426|"     Acute kidney injury (AKI) is a common and under-diagnosed problem in patients with liver     cirrhosis, and is associated with significant illness and preventable death. Blood (serum)     creatinine is the current test for kidney function, but it is an insensitive and non-specific     marker in cirrhosis. The investigators hypothesise that blood (plasma) levels of kidney     injury molecule-1 (KIM-1) will detect AKI earlier and predict the risk of worsening AKI in     cirrhosis, thus identifying patients in need of prompt and effective treatment and improving     patient outcomes. The investigators will collect blood and urine samples from cirrhosis     patients admitted into hospital and study the relationship between plasma KIM-1, other     diagnostic 'biomarker' tests that have recently been proposed, and patient outcomes.   "
9819|NCT03156387|"     The aim of present study was to compare the keratinized gingival tissue measurements, degree     of subjective complaints, and functional complications of using an 980 nm diode laser versus     a scalpel for frenectomies. Thirty-six patients requiring frenectomies, between 18 and 51     years old, were randomly assigned to either scalpel or diode laser treatments. The soft     tissue measurements, including the keratinized gingiva width (KGW), attached gingiva     width(AGW), and attached gingiva thickness (AGT), were recorded before surgery, immediately     after, one week later, and one, three, and six months after surgery. In addition, the     functional complications and the morbidity (level of pain, swelling, and redness) were     evaluated during the first postoperative week using a visual analog scale (VAS). The VAS     scores indicated that the patients treated with a diode laser had less discomfort and     functional complications compare with scalpel surgery.   "
9820|NCT03156374|"     This proof of concept study is designed to determine the practicality of using home ovulation     tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in     comparison to the standard ultrasound and serum monitoring currently conducted by many IVF     clinics. The study will evaluate the ability of home ovulation tests to accurately time     Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition,     women's likability and stress associated with timing a FET cycle using both methods will be     evaluated by collecting qualitative data using standardised questionnaires.      The impact of psychological stress on FET outcome such as implantation rates and viability at     first scan will be considered in order to gather information for the design of a larger     clinical study and basic financial data will also be collected, in order to pilot a     cost-effectiveness evaluation of the two FET timing methods.   "
9821|NCT03156361|"     Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose     Safety, Tolerability and Efficacy Study   "
9822|NCT03156348|"     Adverse drug events (ADE) are one of the major problems affecting quality of care and     achievement of therapeutic goals in older adults (OA), increasing re-admissions, hospital     stays, resource use, and problems on patient safety. The present study aim is to determine     the impact of the clinical pharmacist interventions on the prevention of ADE in OA at 3     months post-discharge compared to usual care.      A randomized clinical trial of two parallel groups 1: 1 (control and intervention) plus a     historical control group will be carried out at the Internal Medicine Service (IMS) of the     teaching Hospital at the University of Chile. The sample will be of 611 patients (242 per     each parallel group and 127 of the historical control group) of 60 years or older, admitted     to the IMS for acute pathology or decompensation of chronic pathology, with survival over 6     months, who is under pharmacological therapy and have a caretaker or responsible contact     person at discharge.      The historical control group will receive usual care and the parallel control group will also     receive training on pharmacogeriatrics. The intervention group will receive the care of a     clinical pharmacist during hospitalization, at discharge and post-discharge, through a home     visit at 30 days post-discharge and a telephone call at 60 days post discharge.   "
9823|NCT03156335|"     The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with     treatment-refractory OCD. This study is designed as a prospective, single arm, nonrandomized     study. Assessments will be made before and after MRgFUS for adverse events related to     treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain     chosen for ablation will be the anterior limb of the internal capsule (ALIC) (i.e     'capsulotomy'). Safety will be assessed prospectively in radiologic and clinical terms.     Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the     evolution of the lesion in the anterior limb of the internal capsule. Patients will be     clinically followed up at Day 1, Month 1, Month 3, Month 6 and Month 12 post-procedure. At     every follow-up visit, patients will be evaluated for general health, neurological changes,     as well as for device/procedure related adverse events. Imaging will also be performed with     positron emission tomography (PET) and MRI, as per the Month 3 and Month 12 post-procedure.     Feasibility will be evaluated by determining the rate of patient accrual, the tolerability of     the procedure for patients, and the technical ability of heating the ALIC to lesional     temperatures.   "
9824|NCT03157518|"     Obesity is a major health concern in the Deep South resulting in a growing number of     metabolic disorders that strain the resources of our healthcare system. Obesity is recognized     as a major risk factor for asthma. The Centers for Disease Control and Prevention (CDC) has     stated obesity is associated significantly with the development of asthma, worsening asthma     symptoms, and poor asthma control. This leads to increased medication use and     hospitalizations.      Variations in the airway microbiome are correlated with the risk for development of asthma,     and populations of different bacteria vary by phenotype amongst severe asthmatics .     Proteobacteria are found in greater proportion in asthmatic subjects relative to healthy     controls (37% vs 15%) while non-asthmatic subjects have a relative abundance of Firmicutes     (47% vs 63%) and Actinobacteria (10% vs 14%) compared to those with asthma . Amongst those     with asthma, obese asthmatic subjects have a relative abundance of Bacteroides (54%) and     Firmicutes (26%). Notably, both phyla are part of the gastrointestinal microbiome, suggesting     inoculation through gastroesophageal reflux which may be more common in obese individuals.     Asthmatics identified as having improvement in their asthma control following treatment with     inhaled corticosteroids appear to have a greater relative abundance of Actinobacteria (79.8%)     in their airways relative to other asthmatics. Actinobacteria have been associated with the     production of anti-inflammatory proteins and are speculated to be involved in increasing     steroid responsiveness. Other studies have demonstrated that oral administration of     probiotics, including Bifidobacterium species within the phyla Actinobacteria, lead to     reduced Th2 cytokine production and eosinophilic inflammation, along with promotion of     Regulatory T-cell (Treg) populations within the airway. We hypothesize that administration of     over the counter oral probiotics containing Actinobacteria (Bifidobacterium) to obese     asthmatic subjects will result in decreased airway inflammation and better asthma control by     immune modulation.   "
9919|NCT03156101|"     This is a single arm, open-label, uni-center, phase I/II study to determine the safety and     efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute     lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT,     or are otherwise ineligible for allogeneic stem cell transplant.   "
9825|NCT03157505|"     Local allergic rhinitis (LAR) is relatively new disease. The question of effect of allergen     specific immunotherapy on LAR is open. The randomized, double blind placebo controlled trial     of birch subcutaneous AIT on LAR were performed in twenty eight patients. The therapy was     performed during 24 months in proportion 15 patients with AIT and 13 placebo. The primary     endpoint was decreased of symptoms medication score (SMS). Additionally monitoring serum     specific IgE, specific IgG4 and nasal specific IgE (nsIgE) to Bet v1 and parameters of safety     and quality of life were provided.   "
10036|NCT03154580|"     The purpose of the proposed study is to examine the relationship between marijuana reminders,     or cues, craving for marijuana, and marijuana use. The principal investigator is also     assessing whether N-acetylcysteine, can reduce marijuana craving or use.   "
9827|NCT03157479|"     Background. The use of a comprehensive strategy providing low tidal volumes, peep and     recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative     respiratory function and clinical outcome. It is unknown whether such ventilatory approach     may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and     Trendelenburg position may alter lung volumes and chest-wall elastance.      Objective. The investigators designed a randomized, controlled trial to assess the effect of     a lung-protective ventilation strategy on postoperative oxygenation in obese patients     undergoing laparoscopic surgery.   "
9828|NCT03157466|"     Although it is now recognized that a variety of respiratory abnormalities, such as     diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate     hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in     patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has     been found to be an independent risk factor for prolonged (> 13 days) mechanical ventilation.     It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it     actually contributes to the development and progression of respiratory failure.      The aim of this study will be to assess respiratory muscle function after thyroid hormone     substitution therapy in mechanically ventilated patients with the NTIS.   "
9829|NCT03157453|"     Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic)     will be included in the study, regardless of its severity, history, the presence of     anticoagulant or antiagrégant.      The collection should be done as soon as possible, in the reception of vital emergencies or     in the urgencies. The collection consists of the realization of a Glasgow score and a scale     of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The     collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is     filled by medical personnel trained.      The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended,     which will be made during a following consultation or by phone. Additional data will be     collected on the folder (ventilation time, days of hospitalization, mortality).   "
9830|NCT03157440|"     An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate     it's accuracy and usefulness as a screening device for patients with symptoms of OSA   "
9831|NCT03157427|"     This study evaluates the performance of CRYOBEAUTY MAINS, a Cyto-selective Cryotherapy     based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one     application of CRYOBEAUTY MAINS in one hand (right or left hand according to the     randomization code).   "
9832|NCT03157414|"     This is a single-center, prospective, controlled, double-blind, randomized study. A total of     50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM)     will be included more than 1 year after transplantation and radomized 1:1 to empagliflozin     (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular     filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous     glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including     visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at     baseline and after 24 weeks in addition to standard safety measurements. Two safety visits     will be performed at week 8 and 16. All concomitant medication, diet and exercise will be     kept stable during the study period. The objective of the present study is to answer whether     empagliflozin safely and effectively improves glucose metabolism together with weight loss in     renal transplant recipients with PTDM.   "
9833|NCT03157401|"     To compare the two administration methods of tranexamic acid for patients undergoing the     first unilateral THA, to explore the effects of tranexamic acid on perioperative blood loss     from the aspects of dominant blood loss, hidden blood loss, blood transfusion rate, mean     blood transfusion volume and safety so as to further clarify what kind of medication is more     effective.   "
9834|NCT03157388|"     Alcoholic hepatitis (AH) is a severe alcohol induced hepatic inflammation that leads to     jaundice and liver failure. Gut derived bacterial translocation to the liver is currently     thought to be one of the main inflammatory drivers of the disease.      This project investigates the effects of gut sterilisation with broad spectrum antibiotics in     patients with AH   "
9835|NCT03157375|"     Age-related cataract is the main cause of impaired vision in the elderly population     worldwide. In the UK, more than half of people who are over 65 years old have some cataract     development in one or both eyes. The only treatment that can restore functional visual     ability is cataract surgery where the opacified crystalline lens is removed by     phacoemulsification and an artificial intraocular lens is implanted. It is estimated that     around 10 million cataract operations are performed around the world each year. Cataract     operations are generally very successful, with a low risk of serious complications.      During the past two decades, cataract surgery underwent tremendous change and modernisation     resulting in today's small incision phacoemulsification surgery and a safe technique with a     short rehabilitation time for the patient. Traditional spherical monofocal intraocular lenses     (IOLs) restore best-corrected vision and may lessen the need for spectacles. These IOLs     correct only the spherical portion of the total refractive error and do not correct corneal     astigmatism. Astigmatism is a visually disabling refractive error affecting the general     population, especially those with cataract. At least 15% to 20% of cataract patients have 1.5     diopters (D) or more of corneal or refractive astigmatism. With increased patient     expectations, the trend is not only to remove the cataract but also to address the problem of     pre-existing astigmatism at the time of surgery.      Surgical-induced astigmatism can be reduced by smaller incisions, i.e. microincision cataract     surgery (MICS), which by definition is surgery performed through incisions smaller than 2.0     mm, reducing the need for suturing. This results in better corneal optical quality, thus     improving visual outcomes. There are also other surgical options to correct preexisting     astigmatism during cataract surgery like: selectively positioning of the phacoemulsification     incision; astigmatic keratotomy with corneal or limbal relaxing incisions; excimer laser     refractive procedures such as photorefractive keratectomy, laser in situ keratomileusis, and     laser-assisted subepithelial keratectomy; or implanting pseudophakic toric posterior chamber     intraocular lenses (IOLs).      Toric IOLs have been shown to result in good visual and refractive outcomes. Combined with     MICS, these IOLs can allow effective correction of cylindrical errors intraoperatively,     improving visual quality and thus leading to spectacle independence. Plate haptic and loop     haptic toric IOLs have been considered for about a decade but have been associated with     postoperative rotational instability. Rotation of a toric lens from its intended orientation     degrades its corrective power, with approximately 3.3% loss of cylindrical power for every     degree off axis. A misorientation of approximately 30° negates the effectiveness of     astigmatic correction, and a misorientation of more than 30° may induce additional     astigmatism. Although some patients are asymptomatic despite induced astigmatism, others     experience symptoms such as blurred or distorted vision, headache, fatigue, eyestrain,     squinting, or eye discomfort. Thus, IOL orientation stability is an essential goal in toric     IOL design.      RATIONALE      The purpose of this study is to assess the axial IOL rotation and optical quality     (refraction, visual acuity, contrast sensitivity, decentration and tilt) and capsular bag     reaction after micro-incision surgery with an IOL implantation in cataract patients - HOYA     Vivinex iSert® model P261.   "
9850|NCT03157180|"     Perioperative anaphylactic reactions are immediate, hypersensitive reactions that are     potentially life-threatening resulting from a sudden release of mediators from mast cells and     basophiles. Which is due to either immune (IgE or non-IgE mediated) or non-immune mechanisms.     Pseudo-allergic are defined as those reactions that produce the same clinical symptoms with     anaphylaxis but are not IgE mediated, occur through a direct nonimmune-mediated release of     mediators from mast cells and/or basophils or result from direct activation.so     pseudo-allergic reactions do not require previous contact with the substance. Recent studies     have shown that a mast-cell-specific receptor,G-protein-coupled receptor MRGPRX2,is crucial     for pseudo-allergic drug reactions.in this study. In the study, we will examine the MRGPRX2     gene in patients with pseudo-allergic reactions during anesthesia, aiming at clarifying the     relationship between pseudo-allergic reactions and MRGPRX2 gene.   "
9851|NCT03157167|"     To determine the safety of escalating doses of Tc 99m tilmanocept in HIV (human     immunodeficiency virus) subjects with confirmed KS.   "
17211|NCT03060252|"     This is a prospective registry study to surveil early liver injuries caused by Zhuanggu     Guanjie Pill (ZGGJ Pill) through a non-intervention observational way. And attempt to     establish a predictive model to screen susceptibilities to ZGGJ Pill.   "
9865|NCT03156985|"     DONATE study is a multi-center, prospective cohort, single arm, observational study to be     performed in 3000 Chinese type 2 diabetes mellitus (T2DM) patients recruited from 100 tier 2     or 3 hospitals, China.It is a drug intense monitoring study required by China Food and Drug     Administration (CFDA) to assess the newly approved drug in at least 3000 patients within the     first five years after commercial launch. The primary objective is to demonstrate the safety     of dapagliflozin by assessment of the incidence of adverse events and serious adverse events     during 6-month follow up in Chinese patients with T2DM.   "
9866|NCT03156972|"     Rhumatic heart disease patients with mitral regurge untile know had adibat for timming of     surgical interferance our study aim to solve this problme using a new technic in     echocardiography called speckle tracking which is more accurate in estimating a changes     occure to myocyte of the heart and so chosing the proper time for surgery   "
9836|NCT03157362|"     This experiment aims to examine the effects of transportation via social presence in near     and far virtual environments, on pain threshold in two groups: 1. healthy volunteers in an     induced pain task, and 2. older adults suffering from pain. In the first, pilot group, a     within-subjects study, participants will complete a series of induced-pain heat ramps in     virtual environments that are near or far—in other words, they will either duplicate     their actual physical environment, or represent another location. A second factor in this     experiment will be mediated social presence, in which participants interact with confederates     as avatars in either condition. The hypotheses follow: H1: Participants who feel present in a     remote location will have a higher pain tolerance than those in a near location. H2:     Participants who feel socially present with a confederate will have a higher pain tolerance     than those who are alone in a virtual environment. H3: There will be an interaction between     social presence and virtual environment such that participants who feel socially present in a     remote location will have the highest pain tolerance overall. Building on these results,the     next step will be a long-term study on older adult pain patients. In this step, the most     successful condition in the first study to lightweight, portable headsets that can be used     outside of the lab environment. This intervention will be tested on older adult patients who     are suffering from chronic pain.   "
9837|NCT03157349|"     The purpose of this study to compare the effect of Biofreeze® versus a Placebo on neck pain,     disability, fear avoidance, and range of motion prior to and following cervical manipulation     over the course of one week among patients with acute neck pain.   "
9839|NCT03157323|"     The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in     children and adolescents undergoing treatment for acute lymphoblastic leukemia.   "
9840|NCT03157310|"     Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine     kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has     been confirmed by a number of prospective clinical trials. The researches aim to analysis     whether bone metastasis could affect the survival of NSCLC patients who were effective in     Gefitinib treatment over 6 months.   "
9841|NCT03157297|"     The purpose of this study is to characterize performance of the MARVEL algorithm downloaded     into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV     block.   "
9842|NCT03157284|"     This Study Evaluate the efficacy of the subministration of fermented rice flour (7 g/day) on     the clinical course of patients with moderate or severe Atopic Dermatitis, in terms of a     reduction in the SCORAD score, during the study period and four weeks after the suspension of     the treatment.   "
9843|NCT03157271|"     Subjects between 14 and 40 years of age referred to physical therapy with a diagnosis of PFPS     will be randomly assigned to one of two groups. The first group (PFPS) will be treated     pragmatically. The second group (PFPS+DN) will receive the same pragmatic approach with the     addition of dry needling intervention. The dry needling intervention will be delivered based     on the treating physical therapist's examination of the patient's soft tissue mobility     deficits, muscle activation deficits, or referred pain patterns.   "
9844|NCT03157258|"     People living with HIV infection (PLH) are clustered in friendship groups with other HIV+     persons, and an intervention delivered to all members of PLH social networks allows HIV+     people who are friends in day-to-day life to provide one another with support for entering,     remaining, and adhering to HIV medical care. Moreover, an intervention delivered to groups     attended by HIV+ persons who are friends increases HIV medical care engagement and decreases     problem drinking more than individual counseling, probably because the network intervention     harnessed mutual peer social support among friends who share the same HIV status, face     similar coping issues, and interact together in day-to-day life. The planned research will be     conducted in two phases in St. Petersburg, Russia.   "
9845|NCT03157245|"     The objective is to determine the incidence of thrombosis on central venous catheters in     patients hospitalized in a surgical critical care unit, in the immediate postoperative period     of urological or digestive carcinological surgery, and receiving parenteral nutrition.   "
9846|NCT03157232|"     In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter     sensors and compared against the hemoglobin measurement from the subject's blood sample under     controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the     device's 8-17 g/dL specification range.      The purpose of the study was to evaluate a change in the sensor component and to assess     performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not     uniform across the accuracy range.   "
9847|NCT03157219|"     Burden of HF in India is approximate 2-5 million patients with an estimated prevalence of     2-3/1000 population. HF is responsible for approx1.8 million admissions annually in India.     Very few studies are there in India which shows the detailed documentation of HF.      Manipal Heart failure Registry (MHFR) is an institutional level Heart Failure disease     registry. In MHFR the investigator will document the detailed information about heart failure     patients admitted or referred to Department of Cardiology, Kasturba Medical College, a     constituent college and teaching hospital of Manipal University.      MHFR will include cohorts of patients with acute heart failure (AHF), with the intention of     implementing a long-term follow-up, the use of health economic assessment to evaluate the     degree of resource utilization; and quantifying the burden on quality of life for patients.     Utilization of drug in HF patients will be evaluated as a part of this study to prevent the     use of inappropriate drug therapy and to improve overall drug effectiveness and outcomes.     Hence the protocol sought to identify the characteristics and long-term outcomes of Indian     patients with acute heart failure admitted in an Indian tertiary care center in South India.      There are no risks to patients participating in the registry study, as standard of care     quality will not be affected. It is unlikely that there will be any direct benefit as a     result of participation in the HF-disease registry. However, the information contained within     this non-interventional registry study will be used for research studies directed at     improving the knowledge and treatment of acute heart failure as well as improving patients     treatment in the future.      The potential impact of proposed research (Manipal Heart Failure Registry) is envisioned to     be four-fold:        1. to enable a broad overview of the routine medical practices for HF treatment;        2. to assess the healthcare resource utilization and drug utilization review for heart          failure patients        3. to assess the burden of disease (mortality, re-hospitalization) in the long term; and        4. to provide a novel overview of the impact of HF syndrome on quality of life as well as          health economics.   "
9848|NCT03157206|"     Patients with diabetic macular edema treated with aflibercept injections for visual     impairment will be observed in standard care during 12 months. They will undergo visual     assessments by Ultrawide Field angiography at baseline and at 12 months   "
10037|NCT03154567|"     The purpose of the proposed study to examine the links among stress, craving for marijuana,     and marijuana reminders, or cues.      In this study, an agent called yohimbine will be used to produce stress-like responses.     Yohimbine is known to cause stress response in studies of alcohol and other substance use     disorders. This study intends to show it can be used to cause stress in marijuana users as     well.   "
9852|NCT03157154|"     Life expectancy of haemophilia patients (specially severe) has dramatically increase in the     last decades, which lead to the apparition of aging diseases such as cardiovascular disease,     with the potential bleeding risk of antiplatelet therapies and anticoagulants.      The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients     (all severity) with such treatment in comparison to non treated patients, according to the     number of bleeding events in the last year reported by the haemophilia patients under study     treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such     treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely     used in minor haemophilia patients but might lead to increase bleeding risk in other     haemophilia patients.      Secondary endpoint consist in:        -  Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)        -  Evaluate the number of sever bleeding event in patient under study treatments compared          to the control group        -  Evaluate the overall consumption of factor VIII or IX supply in patients under study          treatments compared to control group        -  Estimate the stenosis relapse risk in haemophilia patients with arterial STENT        -  Estimate the embolic risk of haemophilia patients with atrial fibrillation      Population description:      Haemophilia patients (man, all severity)      Age above 50 years, followed during the last 5 years in one of the study centre   "
9853|NCT03157141|"     Ankle osteoarthritis is a progressive degenerative joint disease that is characterized by     severe pain, loss of autonomy, diminished health-related quality of life, functional     disability and diminished physical ability to fulfill occupational duties of life in its     end-stage. Current surgical treatments for ankle osteoarthritis are ankle arthrodesis and     total ankle replacement. Despite the good pain relief provided by these procedures, patients     are still experiencing post-operatively important functional limitations in their activities     of the daily living which affect their independency and quality of life. In order to remain     capable of performing primary activities of the daily living, those patients have to make     functional compensatory adaptations in the ipsilateral adjacent joints that will cause     additional degenerative joint disease in those joints.      Currently, the outcome of foot and ankle surgery is primarily based on clinical, radiographic     and questionnaire outcomes. However, these outcome measures have been criticized for not     being sensitive enough to detect clinically meaningful change in foot function. To tackle     these shortcomings, an advanced clinical examination platform integrating     pressure-force-kinematic measurement devices was developed and showed its clinical value for     the detection of intrinsic foot mobility impairments. Surprisingly, up-to-now, no study has     included this integrated use of three-dimensional multi-segment foot models, plantar pressure     platform and a force platform to report on the functional outcome of an ankle arthrodesis or     a total ankle replacement.      Therefore, a multi-centre study will be conducted with two foot & ankle surgery centres. Both     centres are equipped with the same advanced clinical examination platform. It is believed     that proposed approach has the potential to provide further insight in the true functional     changes related to ankle arthrodesis and total ankle replacement. This may in turn result in     improved rehabilitation, less risk for post-operative complications, earlier discharge and     quicker resumption of normal activities of the daily living, which would make ankle     arthrodesis and total ankle replacement more cost-efficient and could potentially affect     thousands of patients each year. Therefore, the hypotheses of the present study are:        -  Hypothesis (H1): Subjects with an ankle arthrodesis require a greater reorganization of          foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements          of level walking compared to subjects with a total ankle replacement.        -  Null hypothesis (H0): Subjects with an ankle arthrodesis do not require a greater          reorganization of foot and lower limb kinematic and kinetic patterns to respond to          mechanical requirements of level walking compared to subjects with a total ankle          replacement.   "
9854|NCT03157128|"     This is a Phase 1, open-label, first-in-human study designed to evaluate the safety,     tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292     administered orally to patients with advanced solid tumors, including RET-fusion non-small     cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors with increased RET     activity.   "
9855|NCT03157115|"     Measuring cardiac contractility is commonly realized with gold standard echocardiography or     MRI. Portable devices to measure this contractility are not available as for rhythm and     electric function assessment. The new Kinocardiography technology could provide a non     invasive and portable tool to measure contractility.      This device records the electric and mechanic function of the heart. With electrodes and     adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included     in the device to measure the micro accelerations of the body at the body surface when the     device is placed on the skin. Using physics principles and adequate calibration, those     accelerations allow the investigators to calculate parameters such as kinetics energies     related to heart contractility. Kinocardiography is a non invasive and portable technology.   "
9856|NCT03157102|"     In France, over 2.5 million people suffer from asthma, including one-third of children. This     is the chronic respiratory disease leading to the highest rate of hospitalization. The     conventional oxygen delivery means in children are the non-rebreather face mask or low flow     nasal cannula (standard oxygen therapy - SOT). New non-invasive ventilatory support systems     such as High Flow Nasal Cannula (HFNC) are emerging. These are nasal cannulas allowing the     delivery of a high air (or oxygen) flow, exceeding the inspiratory flow of patients with     acute respiratory failure, allowing to deliver a slight positive expiratory pressure while     ensuring humidification and warming of the airways. Aerosol administration is also possible     with excellent efficiency and without interrupting respiratory assistance. Physiological data     and clinical studies in other pathologies suggest the interest of this technique during the     asthma attack, but no comparative study currently exists in this indication. The HFNCs could     have their place upstream of Non Invasive Ventilation (NIV), thus replacing non-rebreather     face mask sometimes not tolerated by the children. The investigators's hypothesis is that     HFNCs could improve patients' health faster, reduce the use of other ventilatory assistance     (NIV, invasive ventilation) and reduce the duration of hospitalization in intensive care     units or continuous monitoring units (CMU).   "
9857|NCT03157089|"     The main objective is to assess the efficacy of afatinib in combination with pembrolizumab,     as measured by objective response (OR) in patients with locally advanced or metastatic     squamous NSCLC who progressed during or after first line platinum-based treatment.      The secondary objectives are to confirm the RP2D, assess the safety profile, and the     secondary measures of clinical efficacy including disease control (DC), duration of objective     response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.   "
9858|NCT03157076|"     The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency     slope and estimates the patient responder rate to CLS in patients with severe chronotropic     incompetence treated with a cardiac resynchronization therapy (CRT) device.   "
9859|NCT03157063|"     The goal of this study is to quantify energy metabolism using indirect calorimetry at rest,     in the presence of excess energy following a meal, and in response to the demand for energy     during exercise. The investigators also will examine the individual and joint associations of     activity and obesity status on neurocognitive domains of appetite control. Participants will     include adolescent males and females (N=80) using a 2 x 2 cross-sectional study design,     stratified by bodyweight (normal vs overweight/obese) and physical activity level (sedentary     vs. active).   "
9867|NCT03156959|"     Enhanced CBT (CBT-E) is an effective treatment for the majority of outpatients with an eating     disorder; however in about 30% of patients remission is made difficult. This may be due to     the concomitant presence of trauma. Therefore we expect that a combination of CBT-E and EMDR,     which is the evidence based treatment for PTSD disorder, would enhance the remission     probability. This trial has a parallel group randomized controlled design. All patients who     will enter in contact with the Regional Reference Centre for Eating Disorders in Verona and     will satisfy inclusion criteria will be randomized to the broad form of CBT-E (CBT-Eb) plus     EMDR or CBT-Eb alone. Patients will be evaluated before the treatment, at the end of     treatment and after 6 months post-treatment with a set of standardized measure to assess     eating disorder symptoms and other possible predisposing and moderating factors. The efficacy     of CBT-E vs CBT-E + EMDR will be evaluated at the end of the treatment and after 6 months in     terms of global score of the Eating Disorder Examination. Moreover the changes in other     secondary outcomes will be considered. This explorative study may suggest new hypothesis for     larger RCTs in order to increase the knowledge on ED.   "
9868|NCT03156946|"     Breastfeeding has a fundamental impact on the short-, medium- and long-term health of     children and has an important impact on women's health. Breastfeeding protects against     gastrointestinal and respiratory illnesses and is associated with better cognitive     development in childhood, particularly in preterm infants. Despite these potential benefits,     preterm infants experience lower rates of breastfeeding initiation and continuation compared     to term infants.      The use of breastfeeding peer support initiatives, in which advice is given by experienced     and trained peer counselors, is an effective way to promote and support breastfeeding,     regardless of a woman's socioeconomic status. Several small studies have shown that     breastfeeding peer support initiatives were effective for preterm infants and that this     efficacy was increased by the co-intervention of lactation consultants.      The purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding     support program among mother-preterm infant dyads in Europe, by evaluating the impact of the     intervention on 1) breastfeeding rates, 2) morbidity and mortality during the     hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health,     4) costs benefits.      The breastfeeding support program will include peer counselors under the supervision of     lactation consultants. Breastfeeding counselors will be voluntary mothers who have had a     positive breastfeeding experience with at least one preterm infant. After a training course,     they will meet the future or new mothers by face-to-face and share their experiences at least     once a week during hospitalization and provide phone support up to 1 month after discharge     from hospital.      The study design will be a stepped wedge cluster trial conducted in 8 NICU in Europe (France,     Switzerland and Belgium). Infants and mothers will be followed up from the time of     hospitalization in the maternity and NICU up to 6 months after the discharge. The cost     analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed     up at 24-months after their discharge   "
9869|NCT03156933|"     Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML)     are frequent. It have been shown that some splicing variants had a prognostic value in AML.      AML are characterized by their propensity to relapse because of the persistence of leukaemia     initiating cells (LICs).      The aim of this study is to determine the splice variants on AML initiator cells and define a     splicing pattern.   "
9870|NCT03156920|"     To develop a pragmatic migraine model the investigators will induce headache in healthy     volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be     pre-treated with sumatriptan. If the headache responds to sumatriptan, the model can be used     to test new drug candidates.   "
9871|NCT03156907|"     The prevalence of analgesics opioids addiction in chronic pain patient is very difficult to     know. Many studies indicated that the prevalence of addiction varied from 0% up to 50% in     chronic non cancer pain patients, and from 0% up to 7.7% in cancer pain patients. Analgesics     opioids use have increasingly been increased in chronic pain for 20 years. However, a long     use, at least 3 months in this type of pain has not proved a large efficiency and we have     noticed a habituation, tolerance and withdrawal when treatment was decreased or stopped. In     current practice, patients with chronic pain, often keep their analgesics opioids despite the     absence of pain relief and benefits in quality of life.      Nowadays, no withdrawal strategy is the reference in chronic non-cancer pain patients with     physical opioid dependence. The most common clinical strategy is progressive decrease of     analgesic opioid. But this strategy is often a failure in these patients (no data are     available in literature).      It's necessary to make a prospective pilot study to assess benefits from this practice.      The primary objective of this study is to assess the success rate at 6 months of opioid     temporary rotation by High Dosage Buprenorphine (BHD) taper dose in chronic non cancer pain     patients (CNCP) with physical withdrawal symptoms making opioid withdrawal impossible.   "
9872|NCT03156894|"     Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the     most feared with a net impact on early morbidity and mortality. The all-cause mortality rate     at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is     secondary in 66% of cases with DPG or multi-organ failure.      The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical     assistance or ventricular assistance. According to several studies, this could reduce early     mortality. Early placement and short-term (<30 days) of support appear to improve survival in     the first year after transplantation.      The haemodynamic parameters revealing this DPG are not clearly described in the literature.      hypothesis of this research is that:        -  DPG risk factors in strasbourg's hospital center are comparable to other European and          international centers.        -  Simple hemodynamic parameters can be used to detect PDG earlier in order to set up          assistance more quickly.   "
9896|NCT03156582|"     This is a French multicentric retrospective study on intention-to-treat comparing results of     LT for HCC before and after the use of the AFP score. The investigators hypothesis is a     better respect of the Biomedicine Agency (the French national transplantation agency)     criteria since the general application of this score in March 2013. The aim of this study is     to determine if the tumoral characteristics at the time of LT are improved and if it modified     the patients'outcome.   "
9943|NCT03155789|"     The main objective of this prospective study is to compare the clinical outcomes after lumbar     fusion for chronic low back pain using the four techniques commonly employed in our surgical     practice. Lumbar fusion stops motion at a painful vertebral segment, which can decrease back     pain. The four techniques are standard transforaminal lumbar interbody fusion (S TLIF),     minimally invasive transforaminal lumbar interbody fusion (MI TLIF), extreme lateral     interbody fusion (XLIF), and axial lumbar interbody fusion (AxiaLIF). Each differ in where     incisions are made and level of invasiveness; not all may be implemented in each surgical     case. The four different techniques are all standard approaches with different advantages and     have yet to be compared in efficacy for relieving chronic low back pain.   "
10059|NCT03154281|"     Open-label, cohort study to determine the feasibility and tolerability of the combination of     daily niraparib and daily or thrice weekly everolimus for one 28-day cycle in patients with     advanced ovarian and breast cancer.   "
9873|NCT03156881|"     Non-alcoholic fatty liver disease is a complex disease that is growing more prominent around     the world especially in North America because of high prevalence of overweightness and     obesity. There are many factors that are associated with this illness and it does not seem to     be the same in every patient. The progression of this disease can with time lead to liver     cirrhosis and even primary liver cancer (hepatocellular carcinoma). Currently, the only     treatment plan involves diet change and exercise.      The goal of this research is to validate that Osteopathy can optimise patient health and to     potentially be another option in preventing/reducing progression of this disease. This     research is important for the future of Osteopathy to educate the public and other     therapists/physicians the benefits this manual therapy has to offer. Previous research has     been done and shown that Osteopathy can help patients with low back pain and type two     diabetes, by affecting glucose and insulin levels with manipulation of the spine and     pancreas.      Another study compared one group of obese patients with chronic low back pain that just did     specific exercises to another group that were given exercises as well as Osteopathic manual     therapy (OMT). Results showed both groups had reduced pain, however only the group with     additional OMT showed improved range of motion in the thoracic spine, and showed greater     degree of improvement overall for these patients. This study shows how OMT can be effective     for individuals with NAFLD for in general these patients are obese and part of their     treatment regime is to exercise to lose weight. The researcher could not find any previous     research on OMT contributing to weight loss, however according to the Reve Pavilion natural     health clinic website (2015), OMT can improve underlying issues such as low back pain,     preventing the person to exercise effectively. The researcher also hopes to gain further     knowledge of this subject, and to show the benefits of collaborating Osteopathy and     Allopathic medicine together to obtain optimal patient care.   "
9874|NCT03156868|"     Recent studies have shown that the assessment of a set of cytokines and / or circulating     angiogenic factors (FACs) could be used to identify prognostic factors predictive of efficacy     and / or potential mechanisms of resistance to antiangiogenic agents   "
9875|NCT03156855|"     The investigators aimed to        1. compare the eradication rates and long term re-infection rates of sequential therapy for          14 days versus bismuth quadruple therapy for 10 days in the first line and second line          treatment        2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication          rate of these regimens        3. assess the impact of these eradication regimens on the antibiotic resistance and          microbiota of the gut flora        4. assess the impact of eradication therapy on the metabolic factors   "
9876|NCT03156842|"     The objective of this clinical study is to evaluate the efficacy and safety by comparing the     fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment     group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with     essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.   "
9877|NCT03156829|"     Trigger finger has a prevalence rate of up to 3%. There are many approaches available to     manage this condition. While corticosteroid injection is widely accepted as the most common     first-line treatment, its superiority over splint treatment has not been established. This     study aims to test the effectiveness of cortisone injections, splint and cortisone+splint to     resolve symptoms.   "
9878|NCT03156816|"     Inflammatory processes have been identified as key mediators of ischemia/ reperfusion injury     in ST-segment elevation myocardial infarction. They add additional damage to the myocardium     and are associated with clinical adverse events (heart failure and cardiovascular death) and     poor myocardial recovery. All the different anti-inflammatory approaches to reduce     reperfusion injury have been disappointing.      Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent     pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary     intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase     release) with a short course treatment of colchicine in comparison to placebo.      One mechanism to explain this effect could be the reduction of adverse left ventricular (LV)     remodelling. LV remodelling is part of the healing process of myocardium after MI. It is     defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV     remodelling is increased by inflammation and ultimately leads to heart failure.      Our main hypothesis is that colchicine with its anti-inflammatory properties significantly     reduces the initiation of adverse LV remodelling, together with a significant reduction of     infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients     referred for PPCI.      After inclusion and randomisation, patients will receive the first part of their experimental     treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5     days. They will be followed up during their hospitalization and until one year. In order to     evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during     their participation: one during their hospitalization and a second at 3 months. At 1 year,     adverse events will be collected by phone.   "
9879|NCT03156803|"     The purpose of this study is to evaluate the effects of an evidence-based healthy eating blog     on dietary behaviors of mothers   "
9880|NCT03156790|"     This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD,     immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant     ASNase (Spectrila®). Since Spectrila is already approved in the European Economic Area for     first-line treatment of ALL patients of all age groups and showed similar efficacy and safety     in comparison to Asparaginase medac no blinding or control groups are necessary. As     underlying treatment protocol the BRALL 2014 treatment protocol will be used.   "
9881|NCT03156777|"     Evaluating the application value of a new circulating tumor cell detection method for     advanced gastric cancer patients in prediction of the prognosis and early evaluation of the     result of postoperation adjuvant chemotherapy.   "
9882|NCT03156764|"     In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a     important parameter indicating the balance of pulmonaty and systemic circulation.      This study will calculate Qp/Qs using variables measured using non-invasive monitors     (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated     using variables obtained from blood sample.   "
9897|NCT03156569|"     The purpose of this study was to investigate the salivary levels of inflammatory and their     association with oral health in xerostomía patient   "
9920|NCT03156088|"     Overactive bladder syndrome (OAB) is a prevalent disorder that affects about 10% of the adult     population and > 40% of elderly. It is defined by the presence of urgency, with or without     urge incontinence, in the absence of infection or other pathology. In 1997 through 1999,     sacral nerve stimulation SNS (InterStim, Medtronic Inc., Minneapolis, Minnesota) was approved     by the U.S. Food and Drug Administration (FDA) for treating urge urinary incontinence,     urinary urgency, and frequency. Despite the large numbers of SNS performed, the only     objective clinical evaluation of OAB is urodynamic detrusor instability (UDI) with some     evidence suggesting a correlation with outcomes after sacral neuromodulation.      Interestingly, the mechanism of action of SNS is not fully understood. Theories include     direct activation of efferent fibers to the striated urethral sphincter causing reflex     relaxation of the detrusor or potential activation of afferent fibers selectively which can     lead to inhibition at spinal and supraspinal levels. Somatic sacral afferent inflow     activation at sacral level affects the storage and emptying reflexes in the bladder and     central nervous system, explaining the beneficial effects of neuromodulation on both storage     and emptying functions of the bladder. Malaguti and his colleagues detected somatosensory     evoked potentials during sacral neuromodulation, revealing that sacral neuromodulation works     by both sacral afferent activity and somatosensory cortex activation. As sacral     neuromodulation is clinically proven for both storage and emptying bladder dysfunctions, it     is difficult to isolate its action to either sacral afferent or efferent circuits in the     micturition reflex pathway. In our study, we are going to study sacral neuromodulation     outcome predictors from the clinical and urodynamic perspectives in order to help identifying     the right candidates for sacral neuromodulation procedure.   "
9883|NCT03156751|"     This study used a pre post intervention mixed methods quasi-experimental design with a group     of health facilities offering antenatal care (ANC) services (primary health centers in rural     area) as the sampling units. This study was conducted in three phases, which consisted of a     situational analysis using qualitative methods (Phase 1), selecting an appropriate test     through evaluating 4 candidate tests and the participatory design and implementation of an     intervention that included onsite training, provision of supplies and medicines, quality     control and supervision (Phase 2), and an evaluation combining review of record tools,     interviews, time motion study and estimating incremental costs (Phase 3). The conceptual     framework draws on multilevel assessment (MLA), policy triangle framework, Medical Research     Council framework for designing complex interventions and the Normalization Process Model     (NPM). Methods included document review, seventy five interviews were conducted with health     providers, district managers, facility managers, traditional healers, pregnant women,     community health workers, and Non-Governmental Organizations (NGO) managers in phase I and     fourteen in phase III, non-participant observation, time-motion study, incremental cost     analysis, and sensitivity, specificity and ease of use analysis of four candidate point-of     care tests. Data were collected between 2012 and 2014. Qualitative data were analyzed through     thematic analysis supported by Nvivo software. Quantitative data were analyzed through     descriptive statistics such as frequency, mean and median supported by SPSS. Phase I     identified barriers to implementation and uptake of syphilis testing at health provider and     community levels. The most important barriers at provider level included fragmentation of     services, poor communication between health workers and clients, failure to prescribe     syphilis test, and low awareness of syphilis burden. Cost of testing, distance to laboratory     and lack of knowledge about syphilis were identified as barriers at community level. Phase     II: Alere DetermineTM Syphilis was the most sensitive of the four point-of-care tests     evaluated. The components of the intervention were successfully implemented in the selected     health facilities. Overall, phase III showed that it is feasible and acceptable to introduce     a point of care test for syphilis in antenatal care services at primary health care level     using the available staff. The findings suggested that an intervention that introduces point     of care test for syphilis at antenatal care services is feasible, acceptable, and of     comparable costs to HIV screening in pregnancy. Nonetheless, instructions and supervision     need to be clearer to achieve optimal levels of screening and quality control, and barriers     identified by health workers need to be overcome. The point-of care test for syphilis is     likely to be acceptable by health workers as a routine service and incorporated as a normal     practice in Burkina Faso context.   "
9884|NCT03156738|"     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and     immunogenicity of MT-2990 in healthy male subjects.   "
9885|NCT03156725|"     The objective of this study was to compare the absorption of a new iron product, iron     enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope     technique.   "
9886|NCT03156712|"     Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly     possibly leading to higher concentrations of non-transferrin bound iron which induces     oxidative stress. The objective of this study was to determine how quickly iron enters into     blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to     ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind,     cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as     20 mg iron as ASP.   "
9887|NCT03156699|"     This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in     STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary     intervention). The aim is to add to the existing research field surrounding F-QRS. It is     hypothesised that patients with F-QRS present on the surface ECG, following PCI, will have     incurred a higher degree of damage. As a result, it is hypothesised that these patients will     have reduced LV (left-ventricular) systolic function, increased incidence of regional wall     motion abnormalities (RWMAs), and increased troponin levels on admission. This study will     additionally look for correlations between F-QRS and culprit vessels. To our knowledge there     is minimal research regarding this.   "
9888|NCT03156686|"     Evaluation of the efficacy, safety and and cost of home care versus conventional     hospitalization care at 3-months in patients with worsening chronic heart failure.   "
9889|NCT03156673|"     Bronchial basal cells are proved to be able to regenerate lung structures to repair the     injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which     may result in the failure of pulmonary function rescue clinically.In our research, autologous     bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat     the disease. Specifically, autologous bronchial basal cells will be dissected from     brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and     transplanted into lung to regenerate new alveoli and bronchus structures and re-establish     pulmonary system.   "
9890|NCT03156660|"     The study aims to randomize 400 participants to 1 of 3 arms: a) a weight stability     intervention prior to smoking cessation (Group 1); b) a weight loss intervention prior to     smoking cessation (Group 2); or c) a self-guided weight management prior to cessation (Group     3) and to determine the efficacy of the interventions on preventing weight gain at 12 month     follow-up. All 3 conditions receive a highly efficacious behavioral smoking cessation program     and 6 months of varenicline pharmacotherapy (ChantixTM), the most efficacious medication for     smoking cessation.   "
9891|NCT03156647|"     The aim of this study is to determine whether a significant reduction in the total level of     alpha-synuclein and significant increase in the oligomeric form of alpha-synuclein and     therefore the ratio oligomeric:total alpha-synuclein occurs in patients with Parkinson     disease compared to patients with drug-induced parkinsonian syndrome.   "
9892|NCT03156634|"     This is a randomized pilot study comparing the impact of the Patient Activated Learning     System (PALS) on knowledge acquisition, recall, and decision making about antihypertensive     medication compared to an established online health information system (WebMD). We will also     compare the two systems with regard to user experience measures such as understandability and     trust.   "
9893|NCT03156621|"     The primary objective of the study is to demonstrate the reduction of low-density lipoprotein     cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to     placebo after 12 weeks of treatment.   "
9894|NCT03156608|"     This study will be conducted on women in labor. Fetal heart rate monitoring will be     conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care     external fetal heart rate and tocometry. These approaches will be compared with the respect     to need for additional monitoring, amount of nursing intervention, cost and satisfaction of     patients and healthcare providers.   "
9895|NCT03156595|"     Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients     keeps suffering from this side effects disabilities and their quality of life is seriously     affected.      Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve     them.      the purpose of this trial based on our own experience, is to demonstrate the value of using     hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.      The aim will be to sustainably improve the quality of life by expanding self-management of     pain and motor function side effect.   "
46327|NCT02679209|"     A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane     and bone allograft for management of periodontal intrabony defects.   "
9898|NCT03156556|"     Anxiety and depression represent the most common mental health problems. Unfortunately, only     a minority of people in need will seek or access traditional mental health services. Access     to traditional psychological care is even more challenging for linguistic minorities as well     as for people living in rural areas and for young adults - a group that has the highest rate     of anxiety and depression but the lowest rate of consulting traditional     services.Telepsychotherapy can facilitate access to effective psychological care as done in     Australia where the government has been offering an evidence-based 8-week online therapy     program called the Wellbeing Course. This online course helps people manage worry, stress,     anxiety and depression. It has been evaluated in several clinical trials and successfully     implemented as an Australian national treatment service. Its transdiagnostic nature, and the     fact that the guidance of a clinician is not required for an efficient and safe     administration and maintenance of therapeutic gains make it not only a viable option, but     also an easily accessible fist line intervention. More recently, findings from a feasibility     study conducted by our research laboratory have supported the efficacy of a French-Canadian     translation among French-speaking minorities in New-Brunswick. A version of the Wellbeing     Course for young adults has been developed called the Mood Mechanic Course. Empirical support     has been obtained.      This study is a feasibility open trial, the first phase of a 3-phase research program     designed to implement a French-Canadian translation of the Mood Mechanic Course in New     Brunswick targeting groups for which access to traditional services has been most     problematic: youth (18 to 25 years old), people living in rural areas and linguistic     minorities. The course is an 8-week week program based on principles of cognitive behaviour     therapy. It includes five online lessons, do-it-yourself exercises, case stories, and     additional resources on different topic such as sleep hygiene. Twenty young adults will be     recruited across New Brunswick among French-Canadian minority communities. Self-report     measures assessing anxiety and depression will be administered pre/post treatment and at a     3-month follow-up. It is expected that the course will help overcome barriers in help seeking     to improve the mental health of our communities.   "
9899|NCT03156543|"     Deep periprosthetic infection following total joint arthroplasty is a major complication.     Although it only occurs in a small percentage of patients (~1%), it results in substantial     morbidity and a decline in functional outcome. A two stage revision and exchange is commonly     required in order to clear the infection and provide the best opportunity for prosthetic     replantation. Following removal of the infected components, a minimum course of six weeks of     parenteral antibiotics is given and resolution of the infection confirmed through the ESR,     CRP, and repeated aspiration of the joint. In most instances a temporary spacer of     antibiotic-loaded cement is inserted at the first stage and removed at the second operation.      Propionibacterium Acnes is a gram-positive, non-spore-forming, anaerobic bacillus found in     lipid-rich areas, including hair follicles, sebaceous glands, and moist areas of the shoulder     and axilla. Because of its low virulence, infections caused by P. acnes typically have a     low-grade, indolent course, with shoulder pain often the only presenting symptoms after     prosthetic replacement. P. acnes is particularly challenging to both diagnose and to     eradicate, and is a substantial source of morbidity with shoulder arthroplasty.      JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management     of surgical incision sites. Microcell batteries made of silver and zinc, generate an     electrical current when activated by conductive fluids, such as saline, hydrogel or wound     exudate. These microcells create low voltage electrical fields to stimulate the surrounding     area and to provide antimicrobial protection to assist with wound healing. JumpStart has     demonstrated superior broad spectrum bactericidal activity of a wound dressing against     antibiotic-resistant strains of wound isolates within 24 hours.      The use of JumpStart as a prophylactic preoperative dressing to alter the skin flora and     thereby decrease the risk of prosthetic infection has not been investigated to-date. Given     the morbidity of a prosthetic infection, this would be a remarkably valuable intervention for     any joint replacement procedure.   "
9900|NCT03156530|"     By using a static stabilometry platform, the investigators believe the possible verification     of the efficiency of auricular acupuncture points that correlates with regions of our body     that may interfere with static equilibrium.      The present work aims to analyze the effect of the stimulation of atrial points of the lower     limbs on the equilibrium response evaluated by static stabilometry.   "
9901|NCT03156517|"     Action tremor of the arms can be an invalidizing symptom of diseases such as Essential     Tremor, Dystonic Tremor, Parkinson's disease and Multiple Sclerosis. In this study we compare     the efficacy and safety of two different brain targets for deep brain stimulation (DBS) that     both are known to reduce action tremor of the arms. These two targets are called the VIM     nucleus of the thalamus (VIM) and the posterior subthalamic area (PSA), which includes the     Zona Incerta. Both targets can be reached by one lead (wirh four electrode contact).      Patients that are found eligible for DBS because of severe action tremor of the arms are     invited to participate. After randomization, half of them are stimulated first in the VIM for     3 months and then in the PSA for 3 months, and the other half first in the PSA and then VIM     for 3 months each. Tremor severity is scored on a clinical quantitative scale at baseline and     at the end of each of these two 3-month periods, and eventual side-effects are registered.     The best target is then selected and after another 6 months scoring is repeated. We intend to     provide robust data about whether one of the two targets is superior to the other both     regarding ability to reduce tremor efficiently and to avoid or minimize side-effects, or if     there is no significant difference between the two targets. We also carefully check the exact     position of the active electrode contact in the brain and compare this with efficacy and     safety evaluations.   "
9902|NCT03156504|"     The purpose of this research study is to find out if the medication known as ketamine can     help the symptoms of depression. This drug is approved by the Food and Drug Administration     (FDA) but the investigators will use it for a non-FDA approved reason (depression).   "
9903|NCT03156322|"     The aim of this study is to compare the effect of different epidural initiation volumes on     postoperative pain scores, local anesthetic requirements, and motor block in patients who     undergo patient controlled epidural analgesia for postoperative pain after cesarean section.   "
9904|NCT03156296|"     Pediatric laparoscopy has been first described in 1923 by Kelling but its use has increased     since last decade. A laparoscopic approach offers several advantages over an open procedures;     potentially reduces the surgical stress and fluid shifts that may accompany it; in addition     there is less need for postoperative analgesia, reduction of postoperative respiratory and     wound complications; shortens postoperative convalescence, including an intensive care unit     stay; rapid return to normal diet and decreased overall hospital stay.      Despite the minimally invasive nature, pain can be moderate to severe in the immediate     postoperative period.      Inadequate control of post-operative pain leads to several unwanted adverse events ranging     from patients' discomfort and prolonged immobilization to thromboembolic phenomenon and     pulmonary complications.      Analgesic multimodalities were recommended to relieve the post-operative pain. Opioids     although provide satisfactory analgesia, they are associated with unwanted side-effects.      Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves     innervations of the anterolateral abdominal wall. It provides adequate post-operative pain     relieve following various abdominal surgeries.      With the aid of ultrasound or anatomical landmark guidance, local anesthetic (LA) is injected     into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located.      Ultrasound TAP block is also accompanied by a good pain relief and reduced intraoperative and     postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP     block is necessary because the abdominal skin incisions for the ports of laparoscopic     procedure are performed on both sides.      Unfortunately, TAP block duration is limited to the effect of administered LA. Recently,     adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is     a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its     use with bupivacaine either epidurally or intrathecally is associated with prolongation of     the LA effect.   "
9918|NCT03156114|"     This study tests the new medicine BI 754111 alone or in combination with BI 754091 in     patients with advanced cancer. The study tests different doses to find the best dose for     continuous treatment   "
9905|NCT03156283|"     Obstructive sleep apnea (OSA) is a major public health concern n the United States. Positive     airway pressure (PAP) therapy is the treatment-of-choice and gold standard for individuals     with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent     disease and improve quality of life. Nevertheless, PAP adherence rates are low. Most PAP     adherence programs do not address the self-management skills and strategies that promote     adherence and are often too costly and complex to integrate into overburdened clinical     environments. Furthermore, they do not leverage opportunities to change lifestyle behaviors     that occur across the 24h spectrum (i.e., sleep hygiene, sedentary behavior, physical     activity), which have promise to improve OSA symptoms and PAP adherence. The investigators     have previously developed and successfully tested BeWell24, a multicomponent smartphone app     that uses evidence-based behavior change strategies to improve sleep, sedentary, and physical     activity behaviors. The investigators will enhance this app to create SleepWell24.     Enhancements will include: (1) specific behavior change strategies from the evidence-based     Sleep Apnea Self-Management Program to promote PAP adherence; (2) an interface for exchange     of patient data to facilitate patient-provider communication on treatment progress; and (3)     real-time feedback via wireless integration with a consumer-based PAP machine and wearable     sensor. All aspects of this work will be embedded within the Mayo Clinic Arizona Center for     Sleep Medicine. The investigators will test the effects of SleepWell24 in newly prescribed     PAP users and gather data on the feasibility and acceptability of using SleepWell24 compared     to a usual care control group. The investigators will conduct a pilot randomized controlled     trial with participants randomly assigned to (1) SleepWell24; or (2) usual care for 60 days     post-PAP prescription. The investigators will track recruitment/retention rates, app usage     statistics, and measures of treatment satisfaction. The investigators will objectively     measure PAP adherence to test whether the SleepWell24 group will have more hours/night of PAP     usage compared to the usual care group. In an exploratory fashion, the investigators will     also examine the effect of SleepWell24 on selected treatment outcomes (weight, daytime     sleepiness, cognitive impairment, and health-related quality of life) and evaluate social     cognitive and lifestyle behavior mediators of SleepWell24 on PAP adherence.   "
9906|NCT03156270|"     This study evaluates subjective and objective measures of treatment outcome after using the     Aerin Medical Vivaer™ Stylus to treat nasal obstruction   "
9907|NCT03156257|"     By studying the affect of the space environment on vascular cell types, our goal is to     elucidate the mechanism of vascular cell damage in the space environment by exposing vascular     cells to space flight. In this pilot study, The study team propose to assess changes in     transcriptomics of vascular cell types in space compared to those in a ground based study.   "
9908|NCT03156244|"     In this pilot study, a total of 80 patients with prostate or bladder cancer (40 black, 40     white) will complete 3 patient-reported outcome (PRO) surveys: baseline (pre-treatment),     during treatment, and after treatment. The overall goal of this study is to assess whether     collecting patient-reported data is feasible as part of clinical care of cancer patients, and     whether these data are useful for clinicians and patients. Among these 80 patients, those who     agree will also undergo a semi-structured interview to assess value of HRQOL assessment at     the end of the study. Of specific interest is an evaluation of whether feasibility and     perceived value differ between black and white participants.   "
9909|NCT03156231|"     Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing     altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung     disease travelling from 760 m to 3200 m.   "
9910|NCT03156218|"     The PaO2/FiO2 ratio is frequently used to determine the severity of lung injury in     mechanically ventilated patients. However, several mathematical models have shown that     PaO2/FiO2 ratio depends on FiO2. The relationship is complex and depends on numerous     physiological variables, including shunt fraction, and arterio-venous oxygen difference. The     nonlinear relation between PaO2/FiO2 and FiO2 underlines the limitations describing the     intensity of hypoxemia using PaO2/FiO2 and is thus of major importance for the clinician.     Surprisingly, this relationship has only been assessed mathematically. Obviously, the     accuracy of the mathematical relationship depends on the input variables used.      The current study is designed to assess the PaO2/FiO2 vs FiO2 relation in mechanically     ventilated patients without ARDS (n =10) and with mild or moderate ARDS (n =10). In order to     explain the dependency of the PaO2/FiO2 on FiO2, shunt fraction and alveolar - arterial     oxygen difference ((A-a)DO2) will be determined in these patients.   "
9911|NCT03156205|"     (Background) Adults in intensive care units (ICU), especially elderly patients often suffer     from a lack of sleep or frequent sleep disruptions due to physical, emotional stress such as     pain, inflammation, and anxiety. Delirium, acute cognitive dysfunction, which result from     sleep deprivation often leads to prolonged ICU stay and increase medical costs.     Pharmacological and non-pharmacological interventions have been tried to improve the duration     and quality of sleep and to maintain diurnal cycle. (Purpose) The aim of this study is to     assess the efficacy of patient-driven interactive music intervention on sleep promotion in     critically ill elderly adults. Delirium and urine/blood melatonin level will be assessed,     too. In this study, randomized controlled trial for 50 elderly ICU patients who aged over 65     years in each group will be proceeded.   "
9912|NCT03156192|"     The purpose of this study is to investigate how family caregivers of ICU patients perceive     their psycho-social needs and quality of life, how they use music in their everyday life and     perceive music as beneficial to themselves. Participants are adult family members of     critically ill patients in ICU. After obtaining the informed consent form, a questionnaire     will be distributed to each participant.   "
9913|NCT03156179|"     The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the     assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the     state of the art technique for assessing calcium metabolism in the body and has been used in     both healthy and diseased pediatric populations.   "
9914|NCT03156166|"     Ambu AuraGain, I-gel, LMA supreme and LMA classic are the most commonly used supraglottic     airway. In children, they can be used as intubation conduits. However, there has been no     guideline for optimal insertion depth of endotracheal tube through those supraglottic airway.     In this study, the investigators will measure the distance from grille of those supraglottic     airways to glottis using fiberoptic bronchoscope in children undergoing anesthesia. This     distance allows us to predict an appropriate depth of endotracheal tube when it should be     inserted through each supraglottic airway.   "
9915|NCT03156153|"     We are going to carry out a randomized double-blind placebo-controlled trial to study the     efficiency and mechanism of bumetanide on the treatment of children with Autism Spectrum     Disorder.   "
9916|NCT03156140|"     Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three     motions compared to non-motion control at three arterial oxygen saturation target plateaus.   "
9917|NCT03156127|"     The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of     BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in     healthy female volunteers   "
9921|NCT03156075|"     The aim of the study is to investigate whether a simple intervention improves the physical     functioning and reduce mortality after surgery for elderly hip fracture patients in a period     of one year follow up. We hypothesized that the postoperative intervention program decreases     the mortality in one year and improves mobility.      This study is a randomized controlled trial designed as a prospective intervention and a     historical control group from the previous three months admitted operated hip fracture     patients from another study and with bone mineral density and measurement of weight and     height done. The study will include patients of both sexes, 50 years and older, after their     approval to participate and applying exclusion criteria. A baseline assessment will be done     for the included hip fracture patients, who will be admitted to Trauma Unit of Assiut     University Hospitals and will be surgically treated for a period of 1 year. The exclusion     criteria include patients with major accidents, polytrauma, pathological fractures and     bilateral hip fractures. Also patients with thyroid malfunctions, renal diseases, cardiac     diseases, long term immobilization, liver diseases and musculoskeletal disorders. Two     well-trained nurses will carry out the personal interviews in the Trauma Unit ward with each     patient and/or patients 'relatives using a structured questionnaire. Data collection will be     done after providing informed consent.      Bone mineral density, weight and height for every patient will be done. The follow up phone     calls will be done for every patient at 3 months, 6 months and one year postoperative.      Intervention group:      Patients in the intervention Group will be provided with postoperative health education     intervention program, which includes nutrition education for improving general and bone     health and physical exercise training for the patient and his relative before discharge.      This group will receive the usual care prior to the start of intervention and participating     in the study.      The phone calls will include questions about: if the patient is alive or not. If not,     subsequent detailed questions about causes and timing of death will be filled in.      If the patient is alive, subsequent questions about nutrition, commodities and physical     activity will be filled in. Assessment of physical activity will be done by the Western     Ontario And McMaster Universities Osteoarthritis Index (WOMAC).   "
9922|NCT03156062|"     Psoriasis is a multisystem disease predominately manifested as chronic inflammation of the     skin and characterized by scaly, erythematous patches, papules and plaques, which are often     pruritic. As chronic disease, psoriasis waxes and wanes throughout patient life time. The     disease course is modified with initiation and cessation of treatment, and spontaneous     remission is rare. Clinically lesions can be distributed in any part of the body, this leads     to impaired consequences on the perception of body image, social relations and in general on     quality of life.   "
9923|NCT03156049|"     Postdural puncture headache (PDPH) is a common complication associated with neuraxial     anesthesia and diagnostic lumbar puncture (LP). PDPH is defined as a bilateral headache that     develops within 7 days and disappears within 14 days after the dural puncture with a distinct     postural quality. PDPH causes significant short-term disability, prevents ambulation and care     of the newborn (in obstetrics), and results in a prolonged hospital stay.   "
9924|NCT03156036|"     This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT     with temozolomide plus capecitabine in patients with locally advanced rectal cancer.      The primary endpoint is pathologic complete response rates defined as total regression of the     primary tumor.      For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised     (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with     temozolomide plus capecitabine arms. According to the prior phase I results, MGMT     hypermethylated arm is estimated as 70% of total patients and the target pathologic complete     response rate was assumed as 35% in this population when treated with preoperative CRT with     temozolomide and capecitabine (15% in the standard treatment arm or those with unmethylated     MGMT). Investigator would like to demonstrate the superiority in terms of pathologic complete     responses when treated with preoperative CRT with temozolomide plus capecitabine in patients     with locally advanced rectal cancer, and to validate the predictive role of MGMT status   "
9925|NCT03156023|"     A study to evaluate the safety and tolerability of AMG 570 following multiple dose     administration in subjects with rheumatoid arthritis (RA).      A study to characterize the pharmacokinetic profile of AMG 570 following multiple dose     administration in subjects with RA.      Hypothesis: Multiple dose administration of AMG 570 will have acceptable safety and     tolerability profiles in RA subjects within the proposed dose range.   "
9926|NCT03156010|"     The purpose of the proposed study is to compare the sensitivity and specificity of three     oculomotor test devices in normal subjects versus subjects with history of TBI. The study is     designed as a prospective research project in which a group of 120 normal controls without a     history of TBI will be compared to another group of 120 participants (total of 240) who have     a confirmed history of TBI. Each participant will complete the TBI assessment protocol for     each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the     devices will be counter-balanced across participants. Participants will also be screened for     vestibular migraine and visual vertigo, which are two conditions that influence     oculo-vestibular perception in normal and TBI patients and might influence the results from     the three oculomotor devices. Data from each device will be utilized to perform AUC analyses     to determine the respective sensitivity and specificity for each.   "
9927|NCT03155997|"     The purpose of this study is to evaluate the safety and efficacy of the study drug     abemaciclib in participants with high risk, node positive, early stage, hormone receptor     positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.   "
9928|NCT03155984|"     Hepatitis B virus (HBV) reactivation is common during anti-CD20 containing chemotherapy, even     in HBsAg-negative patients with only prior HBV exposure. The optimal timing of commencing     antiviral therapy and the interval of clinical monitoring is uncertain. 25% of the Hong Kong     population has prior HBV exposure. The investigators plan monitor this cohort of patients and     determine (1) the optimal time point for starting antiviral therapy based on the progression     of HBV reactivation, and (2) the optimal interval of clinical monitoring.   "
9929|NCT03155971|"     This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in     Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.   "
9942|NCT03155802|"     This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a     diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy     and followed up for a time period of 6 months post completion of anthracycline chemotherapy.     They will participate in blood and imaging tests with a goal of determining the best method     for predicting the occurrence of cardiotoxicity in this subpopulation.   "
10014|NCT03154866|"     The mode of delivery affects the diversity and colonization pattern of the gut microbiota     during the first year of infants' life.      Probiotics have been observed to positively influence the host's health, but to date few data     about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns     born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079     (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were     detected by using a Next Generation Sequencing technology.   "
9930|NCT03155958|"     Alopecia areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of     hair loss.      Several etiological factors, including psychological, trauma-related, genetic and autoimmune     factors have been considered as possible etiological factors . A T cell-mediated autoimmune     mechanism in genetically vulnerable individuals is the most acceptable etiology.      Alopecia areata presents clinically with well demarcated patches of non cicatricial hair loss     in any hair bearing area with no remarkable gender preference.      Although AA may occur at any age, incidence is high among younger age groups. In fact, it is     the most common form of alopecia seen in children. Various clinical patterns of alopecia have     been described as patchy, diffuse, reticulate, ophiasis and ophiasis inversus. Depending on     the extent of hair loss, it can be classified into alopecia subtotalis, alopecia totalis     (complete loss of scalp hair), and alopecia universalis (complete loss of body hair).      National Alopecia Areata Foundation has devised Severity of Alopecia Tool Score (SALT     score) as a measure of disease severity. Scalp is divided into 4 areas, namely, Vertex-40% of     scalp surface area; right and left profiles-18% each and posterior scalp aspect-24%. SALT     score is the sum of percentage of hair loss in the above mentioned areas.   "
9931|NCT03155945|"     The purpose of this randomized, open-label, parallel, phase 2a study is to determine the     tolerability, pharmacokinetics, and efficacy of APD371 in subjects with Crohn's disease     experiencing abdominal pain.   "
9932|NCT03155932|"     The purpose of this open-label, pilot, proof of concept study is to evaluate the safety,     tolerability, and efficacy of oral etrasimod (APD334) in patients with primary biliary     cholangitis (PBC).   "
9933|NCT03155919|"     Taurine is a nitrogenous compound, naturally present in heart, leukocytes, retina, central     nervous system, especially in muscles. It has several beneficial physiological effects like     antioxidant action, and could increase muscle force contraction and insulin sensibility.     Triathlon is a sport of medium to high intensity, that can causes an increase in the rate of     oxygen consumption during intense exercise and consequently increases free radicals     production and oxidative stress, which may compromise an athlete's performance. Due to the     weekly intense training, triathletes need nutritional care ranging from calories and     nutrients adequacy to the use of specific nutrients that can help to maintain health. Thus,     it is believed that the use of taurine associated with chocolate milk after exercise can     promote general metabolic insulin action in order to favor carbohydrates metabolism     regulation, assist muscle recover and prevent oxidative damage and thus promote triathletes     performance and muscle mass gain. Thus, the aim of this project is to evaluate the effects of     taurine and chocolate milk supplementation in body composition, athletic performance and     oxidative stress in triathletes.   "
9934|NCT03155906|"     INTRO-HCV is a multicentre randomised controlled clinical trial that will compare the     efficacy of integrated treatment of chronic hepatitis C virus infection (HCV) within     medically assisted rehabilitation (MAR) clinics providing opioid substitution therapy (OST)     compared to standard treatment. The trial will recruit approximately 250 HCV infected in     Bergen and Stavanger and about 1000 in a linked observational study.      Intervention: Integrating diagnostic and treatment follow-up for HCV treatment into MAR     outpatient clinics in Bergen and Stavanger including testing for HCV, counselling and     treatment evaluation and treatment delivery.      Primary objectives: Compare the effect of integrated HCV treatment assessed with sustained     virological response at 12 weeks between the MAR outpatient clinics in Bergen and Stavanger     (intervention arm) with standard treatment provided after referral to infectious disease     clinics among patients who receive OST having HCV Secondary objectives: Compare treatment     adherence between the intervention and control arms, and assess changes in quality of life,     fatigue and psychological well-being before and after HCV treatment, as well as changes in     drug use, infection related risk behavior, and risk of reinfection among those with sustained     virological response.      Main endpoint: Sustained virological response of HCV at 12 weeks (± 10 days) Study     population: The target group will be patients receiving care with MAR from involved     outpatient clinics in Bergen, Sandnes and Stavanger who are chronically infected with HCV and     eligible for treatment according to national guidelines.      Study duration: Participants will be included and followed up at least annually for the total     study duration between 2017 and 2021.      Expected outcome: This study will inform on the relative advantages and disadvantages of an     integrated treatment program for HCV into MAR compared to standard care aiming to increase     access to treatment and improved treatment adherence. If the integrated treatment structure     is found to be safe and efficacious, it can be considered for further scale-up.   "
9935|NCT03155893|"     The main purpose of this study is to assess the effect of a single supratherapeutic dose of     AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus     placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using     intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT/QTc and     PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response     (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV     on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy     participants.   "
9936|NCT03155880|"     The investigators will assess the heterogeneity of obese individuals in the United States to     help researchers, clinicians and policymakers to establish goals for obesity treatment and     identify whether differing interventions may be needed.   "
9937|NCT03155867|"     This will be a randomized, cross-over design. Subjects will be randomized to one of six     interventions on six separate study days, 1 week apart.   "
9938|NCT03155854|"     Research is instrumental for improving medical care and the patient experience. Finding new     surgical techniques can create better outcomes and minimize recovery time and complications     for patients. Some patients undergoing trigger finger surgery with a pre-existing Dupuytren's     cord may develop a thickened surgical scar after surgery, which can cause discomfort,     difficulty with moving or using, and other complications in the affected finger(s) or hand.     The investigator is investigating a surgical technique to minimize these potential     complications and scarring after surgery.      Subjects are being asked to take part in this research study because they have been diagnosed     with trigger finger and pretendinous Dupuytren's cord and have decided to undergo surgery     rather than try medical treatment.   "
9939|NCT03155841|"     The investigators propose to deliver and test a life skills intervention targeting the key     domains that fuel HIV disparities among adolescent (ages 13-18) same-sex attracted men in the     United States. This RCT will yield important information regarding the delivery of a     developmentally-appropriate HIV prevention program that reaches racial/ethnic and     socioeconomically diverse sample of adolescent men across four regions in the United States.   "
9940|NCT03155828|"     The purpose of this study is to determine if treatment of obstructive sleep apnea (OSA) with     continuous positive airway pressure in women with both OSA and polycystic ovarian syndrome     will improve the regularity of the women's menstrual cycles.   "
9941|NCT03155815|"     The purpose of this study is to develop and validate the Dementia Population Risk Tool     (DemPoRT) algorithm to predict dementia incidence in the population setting.   "
9945|NCT03155763|"     The morphology of transplanted kidney is considered to be important for graft outcomes in     early and late posttransplant period. Individual histological lesions at the time of kidney     transplantation, such as sclerosis of glomeruli, vascular narrowing and interstitial     fibrosis, and composite histological lesions, which integrate histopathological findings in     different compartments, showed association with suboptimal graft outcomes. However there are     no consistent association between individual or composite lesions and transplant outcomes.     Some possible explanations for such inconsistent results are non-uniformity in grading     histological lesions or in defining graft outcomes. Furthermore, studies vary in terms of     patient selection, and some results are not corrected for covariates. It is also unclear,     whether acute biopsy features associated with the donor kidney can provide prognostic     information, in addition to the chronic lesions? This single-center study aimed to evaluate     which acute and chronic histological lesions and composite histological scores in donor     kidney intraoperative biopsies alone or in combination with clinical variables are best     associated with short- and long-term kidney graft outcomes, such as impairment of early     kidney allograft function, immunological acute kidney allograft rejection, pyelonephritis,     allograft function at 1, 3, 6, 12 months, 2, 3, 4 and 5 years, and graft survival at 1 and 5     years.   "
9946|NCT03155750|"     Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating     insomnia disorder delivered by a training course.      Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia     symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week     8.      Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia     disorder recruited from the community will be randomized to ZTEx training or SHE groups in a     1: 1 ratio.      Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and     daytime impairment.      Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour     each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will     receive sleep hygiene education with the schedule and duration that are same to the ZTEx     training group.      Main outcome measures: The primary outcome measure is the ISI score. Other measures include     sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and     Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension.     Acceptability and compliance of ZTEx will be evaluated.      Data Analysis: Differences in the questionnaire scores, subjective and objective sleep     parameters will be examined using a mixed-effects model.   "
9947|NCT03155737|"     Objectives: To test the feasibility of the study design and clinical effects of     self-administered acupressure on relieving knee osteoarthritis (OA) pain.      Hypothesis: self-administered acupressure would have a superior beneficial effect compared to     health education control group in terms of pain relief in patients with knee osteoarthritis     across the 6-week study period.      Design and subjects: A pilot randomized controlled trial. 36 subjects with knee OA will be     recruited; 18 per group. All eligible subjects will be randomized to either self-administered     acupressure or health education control group in 1:1 ratio.      Interventions: Subjects in the self-acupressure group will attend two 1.5 hours training     sessions to learn self-acupressure and will practice self-acupressure every morning and night     for 6 weeks; subjects in the education control group will receive two 1.5 hours training     sessions to learn the health information related to knee OA.      Main outcome measures: The primary outcome measure is the numerical rating scale for knee     pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index,     knees' range of motion (ROM), and SF-6D. Acceptability of the self-acupressure training     course will also be evaluated.      Data Analysis: Differences in the questionnaire scores and ROM will be examined using a     mixed-effects model. Both completer and intention-to-treat analyses will be conducted. Effect     sizes will be computed by dividing the difference in means by the pooled standard deviation.   "
9949|NCT03155711|"     This study aims to compared the effects of high flow nasal during the induction and during     the weaning of anesthesia on intraoperative and postoperative oxygenation and postoperative     atelectasis in obese patients undergoing bariatric surgery versus the standard of care, which     consists in supplemental oxygen with face mask (Venturi mask).   "
9950|NCT03155698|"     Vitiligo is a relatively common acquired chronic disorder of pigmentation characterized by     the development of white macules on the skin due to loss of epidermal melanocytes .Affecting     approximately 0.5%-2% of general population worldwide, without predilection for sex or race.   "
9977|NCT03155347|"     This is a randomized, double-blind, multi-center, parallel-group study to evaluate the     efficacy and safety of subcutaneous (SC) tocilizumab (162 milligram [mg] every 2 weeks [Q2W])     given as monotherapy and in combination with MTX versus MTX given as monotherapy, in     participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate     response to current DMARD therapy. The study comprises a 24-week double-blind treatment     phase, followed by a 24-week extension phase.   "
9951|NCT03155685|"     There are not lots of recommendations for the use of antipsychotics in palliative care. The     National Agency for Accreditation and Evaluation in Health (ANAES) and the French Society for     Accompaniment and Palliative Care, in 2002, make it the first-line treatment for confusion in     palliative care, but there are no information on the molecules to be used, the dosage or the     route of administration.      Many symptoms can motivate the prescription of an antipsychotic and many molecules exist.     Their mode of action is substantially the same but their pharmacological properties sometimes     give them different beneficial effects or side effects. They are studied in psychiatry but     very little in palliative care.      Depending on the symptom (s) presented by the patient, either of these antipsychotics may be     preferred. Use appear to differ from one center to another.      The investigator propose a multicenter, prospective, observational study describing the     antipsychotics used according to the symptom.      This study should include 100 patients over the age of 18 years in palliative care     (regardless of pathology) who are not taking antipsychotics and for whom the decision to     introduce an antipsychotic is made regardless of the symptom.      The purpose of this work is to describe the most commonly used antipsychotic according to a     particular symptom, as well as the dosage and route of administration.      The investigator will also evaluate the 7-day efficacy of the chosen antipsychotic on the     symptom that motivated the prescription, and we will compare the dosages of the associated     treatments before and after the introduction of this new treatment.   "
9953|NCT03155659|"     Data linking fish, polyunsaturated fatty acids intake and mortality are lacking and     conflicting. We aim to use data from the China Health and Nutrition Survey (CHNS) and     National Health and Nutrition Examination Survey (NHANES) to investigate the associations of     fish and polyunsaturated fatty acids (PUFA) intake with mortality in Chinese and US     populations. The study findings will be informative for addressing the role of fish and     specific PUFA in human health and improve basis for dietary recommendations.   "
9954|NCT03155646|"     A laparoscopic approach offers several advantages over an open procedures; potentially     reduces the surgical stress and fluid shifts that may accompany it; in addition there is less     need for postoperative analgesia, reduction of postoperative respiratory and wound     complications.      Despite the minimally invasive nature, pain can be moderate to severe in the immediate     postoperative period that requires multimodal analgesia. Inadequate control of post-operative     pain leads to several unwanted adverse events ranging from patients' discomfort and prolonged     immobilization to thromboembolic phenomenon and pulmonary complications.      Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves     innervation of the anterolateral abdominal wall. With the aid of ultrasound, local anesthetic     (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1     are located.      Ultrasound TAP block is accompanied by a good pain relief and reduced intraoperative and     postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP     block is necessary because the abdominal skin incisions for the ports of laparoscopic     procedure are performed on both sides.      Unfortunately, TAP block duration is limited to the effect of administered LA. Recently,     adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is     a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its     use with bupivacaine either epidurally or intrathecally is associated with prolongation of     the LA effect. A major advantage of dexmedetomidine is its higher selectivity compared with     clonidine for α2A receptors, responsible for the hypnotic and analgesic effects of such     drugs.10 Clonidine action, similar to local anesthetic action, and its interaction with local     anesthetics have been explained by three possible mechanisms. First, clonidine blocks Ad and     C fibers. Secondly, clonidine may cause local vasoconstriction, thus decreasing local     anesthetic spread and removal around neural structures. Thirdly, clonidine used in peripheral     blocks intensifies and prolongs analgesia.   "
9955|NCT03155633|"     This study has as main objective to know how the processes of recovery are realized after a     race of marathon. For this, the participants of a marathon race are divided into three work     groups during the 9 days post-marathon, one with rest in the recovery period, another with     continuous race three sessions every 48h and another with three sessions of elliptical every     48h .   "
9956|NCT03155620|"     This screening and multi-sub-study phase II trial studies how well treatment that is directed     by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or     histiocytic disorders that have progressed following at least one line of standard systemic     therapy and/or for which no standard treatment exists that has been shown to prolong     survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells.     Patients with genetic changes or abnormalities (mutations) may benefit more from treatment     which targets their tumor's particular genetic mutation, and may help doctors plan better     treatment for patients with solid tumors or non-Hodgkin lymphomas.   "
9957|NCT03155607|"     Burn wounds cause intense, complex pain, and subsequent burn wound care causes further     intense, episodic pain that is often unrelieved by opioid and non-opioid medications,     resulting in under-treatment of pain. Further, opioid analgesics can have untoward side     effects including respiratory depression, nausea, constipation, pruritus, drowsiness,     lethargy, dependence, and induced hyperalgesia. As one of the most severe types of pain, burn     wound care pain adds to the trauma pediatric patients already experience from the burn itself     impacting quality of life with subsequent behavioral and maladaptive responses, such as     agitation, anger, anxiety, hyperactivity, uncooperativeness, aggression, and dissociation.     Lack of control over the procedure, pain memory, anxiety in anticipation of the repeated     painful nature of the procedure, and transmission of clinician distress associated with     inflicting procedural pain on the child contribute to the pain perceived.      Virtual reality (VR) shows great promise as an engaging, interactive, effective     non-pharmacologic intervention for various painful healthcare procedures, including burn     wound care, therapies, and chronic pain conditions, despite equivocal findings, perhaps due     to methodological issues. Designs of many studies of VR during burn wound care have been case     studies or carefully controlled within-subject designs; sample sizes have been small.     Recommendations for ongoing research include conducting more rigorous studies including     randomized controlled trials (RCTs), repeat design studies, testing VR throughout the     healthcare procedure, comparing VR to other distraction interventions; and using larger     sample sizes.      Primary Aim 1: Compare the effectiveness of age-appropriate, consumer available, high     technology, interactive VR with standard care (SC) on adolescents' acute procedural pain     intensity perception during burn wound care treatment in the ambulatory outpatient clinic     setting.   "
9978|NCT03155334|"     The purpose of this randomized, open label, crossover, single site study is to compare the     PISs of two Multiple Sclerosis clinical trials to elucidate potential aspects of the given     written information that could impact on the smooth running of the studies.   "
9979|NCT03155321|"     The study is designed to assess the awareness of the SAGES Safe Cholecystectomy Program among     polish surgeons, as well as the degree of implementation of this Program during laparoscopic     cholecystectomy performed in Poland. It also gathers the opinion of polish surgeons on     usefulness of each of the SAGES Safe Cholecystectomy Rules   "
9958|NCT03155594|"     A pilot study using the FreeStyle Libre to assess its potential benefits in patients with     diabetes starting when they are inpatients and continuing during the transition of care to     the outpatient setting to see if diabetes care can be improved after discharge.      This study is designed to address the following questions:        1. How do the glucose readings from FreeStyle Libre Pro compare to our inpatient glucometer          system? Is the system is accurate enough to use for clinical decision making?        2. How often does the additional continuous glucose data change inpatient care?        3. Does this technology work with inpatient nursing workflow?        4. Does leaving the patch on at discharge and reading in the office improve transition of          care?        5. Does reading the patch after discharge in the office improve follow-up care?   "
9966|NCT03155490|"     Brief Summary: Trauma is a major public health burden; it is the fifth most common cause of     mortality overall in the US and accounts for the majority of deaths in patients younger than     45. Trauma resuscitations present unique patient care challenges due to the need to perform     complex tasks under uncertain and time-pressured conditions. It is not entirely surprising     that one-third to one-half of trauma patient-related errors occurred in emergency departments     during the initial resuscitation period. Effective team leadership can enhance teamwork and     team adaptability, thus improving teams' ability to handle unexpected and rapidly changing     situations. Simulation-based training provides a clinically relevant practice environment     that has been recommended for team and team leader training.      The purpose of this research is to evaluate the impact of simulation-based leadership     training on clinical teamwork, team leadership and patient care. The investigators     hypothesize that team leadership training will improve team leadership, teamwork, and     critical patient care events during actual trauma resuscitations.   "
9959|NCT03155581|"     Although health-related interventions should become increasingly diversity-sensitive, there     will always be a need of adapting specific interventions to some immigrant populations.     Adapting selected services to the individual cultural and religious background is necessary     to reduce health inequalities and provide effective health care and is dependent on the     active involvement of users. In this proposal the investigators present a community-based     health intervention trial with two parallel interventions aimed at increasing participation     of immigrant women to the existing cervical cancer-screening program. Through this study, the     investigators will provide new practice-based knowledge and a firmer evidence base to improve     health interventions that can contribute to equal health care and good health for all -     including the immigrant population.      Based on identified barriers and factors that influence the interactions between immigrants     and health care professionals for screening of cervical cancer in Norway, the investigators     have develop two adapted interventions. One strategy will target immigrant women, and the     other one will focus on general practitioners. Thus, this proposal will specifically     contribute to the development of personalized health prevention interventions for the most     common cancer-screening program in Norway, with a focus on immigrant's personal circumstances     and health care needs.   "
9960|NCT03155568|"     Diabetic patients suffering diabetic foot disease have sever comorbidities, as hypertension,     ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which     contribute to a high risk profile for anesthesia.      failure rate associated with ankle or popliteal nerve block may be higher than accepted, the     study hypothesized that combined ankle and popliteal block may increase the success rate with     no added complications.   "
9961|NCT03155555|"     The purpose of this study is to evaluate whether carotid Doppler peak systolic velocity can     be an easy to measure possible surrogate for echocardiographic measurement of aortic peak     systolic velocity variation which is an index of fluid responsiveness in mechanically     ventilated children intra-operatively.   "
9962|NCT03155542|"     According to the statistic reports from World Health Organization (WHO) International Agency     for Research on Cancer (IARC), the incidence and mortality rate of colorectal cancer ranked     third and fourth respectively among ten most commonly diagnosed cancer worldwide; moreover,     based on the statistics from Health Promotion Administration, Ministry of Health and Welfare     in Taiwan, the incidence and mortality rate of colorectal cancer ranked second and third     respectively among call cancer in Taiwanese population. However, if colorectal cancer is     diagnosed and treated in early phase, the 5-year survival rate for stage I colorectal cancer     can be up to 90%; on the other hand, the 5-year survival rate for end stage colorectal cancer     is only approximately 10%. Therefore, the screening, early diagnosis od colorectal cancer is     crucial. To date, there are some known risk factors for colorectal cancer, including familial     adenomatous polyposis, obesity, physical inactivity, etc. Alcohol had also been identified as     an important risk factor for colorectal cancer, and the risk could be higher among Asian     population because of the reduced enzymatic activity of some of the alcohol metabolizing     enzymes. Thus, through this study, the investigators hope to find out the risk factors of     colorectal cancer among Taiwanese population, including alcohol metabolizing enzyme gene     polymorphisms and their interaction with environmental factors, to attain the purpose of     early prevention of colorectal cancer.   "
9963|NCT03155529|"     Cervical cancer is one of the most prevalent malignancies in female .To the younger patients,     radical hysterectomy which is a standard operation during the earlier and middle therapy     stage as well as more effective technique like radiotherapy and chemotherapy give them a     longer life expectancy. However, the operation destroys patients' normal pelvic anatomy,     nutrient supplements and internal secretion so that postoperative pelvic floor functional     dysfunction has a destructive effect for their life. There are tremendous studies on clinical     symptoms while few on anatomical changes and the relationship between pelvic floor symptoms     and the dysfunction. Two-dimensional Magnetic Resonance Imaging(MRI), transperineal     ultrasonography， Urodynamic examination and anorectal manometry are frequently used in the     fine-structure varies and pelvic floor function. Now three-dimensional MRI has more     advantages in fine change of Pelvic anatomical and space position，as well as clearly showing     the relationships between the change and space with the pelvic floor function. Based on an     eight-year-study on three-dimensional MRI, we can analyze the postoperational anatomical     changes and the relationship between the changes and the dysfunction by combined anatomic     parameters which are measured on static-dynamic three- dimensional model with clinical     symptoms, transperineal ultrasonography,urodynamic examination and anorectal manometry. We     expect our study could provide scientific basis for on protective and repaired measures of     pelvic floor.   "
9964|NCT03155516|"     This study aims to set up a standardized cancer pain ward - known as the Good Pain Management     (GPM) Ward with streamlined assessment and management procedures to act as a pain management     model. In particular, it will enforce regular pain assessment from and throughout hospital     admission, and treatment protocols introducing the use of strong-opioids in moderate cancer     pain patients, following National Cancer Care Network (NCCN) Adult Cancer Pain Guidelines.     The GPM ward will be compared against current-practice controlled ward.   "
9965|NCT03155503|"     This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical     study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of     SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the     safety, tolerability, and pharmacokinetic profile.   "
17212|NCT03060239|"     The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's     disease and to explore the neuronal network involved in this improvement using NIRS.   "
9967|NCT03155477|"     This a double blind randomised controlled trial (RCT) to determine the effect of Curcuma     Xanthorrhiza supplementation on vitamin D3 administration to disease activity (SLEDAI), IL-6     and TGF-β1 serum in SLE patients with hypovitamin D. SLE patients with hypovitamin D had     milder disease activity, lower IL-6 and higher TGF-β1 serum level when supplemented with     Curcuma Xanthorrhiza and vitamin D3 compared with vitamin D3 and placebo.   "
10060|NCT03154268|"     The purpose of this study is to investigate the reference ranges and rates of gestational     weight gain among Chinese pregnant women, and to analyze the correlation between gestational     weight gain and adverse outcomes.   "
9968|NCT03155464|"     The primary objective of this study is to evaluate the relative intraoperative improvement in     perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A     minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to     Sympathectomy (group 2), will be recruited for this study. This study will enroll     participants in a one to one randomized study design. There is the potential risk of loss of     confidentiality. The study involves the intraoperative assessment of perfusion by     quantitative ICG. ICG is FDA approved for this usage and will be used according to its     labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and     patient and physician assessments. There are no additional physical risks associated with     participating in this study over and above that of the planned arterial reconstruction     (bypass) and sympathectomies.The information collected will be kept confidential and will     comply with the HIPAA.   "
9969|NCT03155451|"     Epithelial ovarian cancer constitutes one of the most common gynecological     malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients     are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer     patients often bears similar genetic and epigenetic features to the related tumor DNA.This     study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.   "
9970|NCT03155438|"     In Vitro Fertilization is considered one of effective treatment for infertile couple.     However, some women do not have adequate response to controlled ovarian hyperstimulation,     resulting in low response which defined as less than 5 retrieved oocytes. There are studies     claiming that live birth rates in these patient lower than normal responder (10-15 retrieved     oocytes). Among factors contributing low response, oxidative stress, resulting from increased     pro-oxidant and/or reduced antioxidant, is considered to effect the functions of follicles     and quality of oocytes. However, there are few studies demonstrating this relation. Objective     of our study is to find the difference of oxidative stress-related gene expression in cumulus     cell and oocyte competence biomarkers from follicular fluid between low responders and normal     responder to controlled ovarian hyperstimulation.   "
9971|NCT03155425|"     This is an open-label, multicenter, non-randomized, phase2 trial to evaluate efficacy and     safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The     primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory     classic Hodgkin's lymphoma.   "
9972|NCT03155412|"     The goal of the study is to analyze deviations in adipogenic potential and metabolic     properties of preadipocytes in subjects with genetic predisposition to type 2 diabetes, and     thus identify factors that underlie hypertrophic growth of adipose tissue associated with the     development of this disease.   "
9973|NCT03155399|"     The purpose of this study is to evaluate the effect of the repetitive proprioceptive     bilateral stimulation for the early recovery of the voluntary muscle contraction in stroke     patients.   "
9974|NCT03155386|"     This study will be proposed consecutively to any patient who angiomammography examination was     requested by the clinician in charge of patient. A randomization will be performed between an     angiomammography examination Standard (SenoBright®) and an optimized angiomammography     examination.      A blinded central re-reading of the acquisition technique will be carried out by 3     radiologists (2 seniors and 1 junior) who will evaluate:        -  The intensity of lesion enhancement        -  The presence and type of artefacts on the recombined images.        -  The quality of low-energy images according to recognized criteria for mammography.      The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for     non-biopsied benign lesions   "
9975|NCT03155373|"     Mitral regurgitation (MR) is a prevalent valvular heart pathology. Indications for surgery     include symptoms, impaired left ventricular function or enlarging dimensions, new onset     atrial fibrillation, pulmonary hypertension, asymptomatic status with a high likelihood of     success.      Asymptomatic severe primary MR can be initially monitored without impairing long term     survival. However, significant symptoms or impairment of left ventricular function is     associated with worse prognosis due to long term heart failure. Some physicians wait for     early symptoms before referring for surgery and this is reflected by a great variation in     referral patterns, but symptomatic status is subjective and difficult to assess. Nearly all     of the surgical indications are based on expert opinion rather than significant evidence     base.      The primary aim of this project is to improve the current guidelines for surgery for primary     MR by finding an objective marker of functional capacity which correlates with surrogates of     prognosis and detects early decline, but returns to normal after surgery.   "
9976|NCT03155360|"     According to recent studies, we want to find evidences that infant colics could be a episodic     symptom associated to migraine as cyclic vomiting syndrome or abdominal migraine are. The     main purpose is to compare the presence of colics in infants between 60 days and 180 days of     life and the presence of migraine in their parents to determine if colicky children's parents     are more migrainous than other parents.   "
17213|NCT03060226|"     Search for blood predictive marker (s) for cutaneous radiosensitivity   "
9980|NCT03155308|"     Colorectal cancer (CRC) is the most frequent gastrointestinal tumor and the second cause of     cancer related death. Colonoscopy is currently the recommended method for detection of polyps     and cancers in the colon. Removal of all adenomatous polyps during colonoscopy has become     worldwide a standard procedure as it has been demonstrated to significantly reduce colorectal     cancer incidence and mortality. It is routine practice to remove all the detected polyps for     pathological evaluation, due to the low accuracy (59% to 84%) to differentiate non-neoplastic     from neoplastic colorectal lesions with white-light endoscopy. The development of electronic     or virtual chromoendoscopy (CE) has aimed to reliably predict histology of colorectal lesions     based on endoscopic features. This technology differentiates between neoplastic and     non-neoplastic lesions base on the analysis of the neo-angiogenesis and the mucosal pit     pattern. Optical endoscopic diagnosis allows the real-time evaluation of polyp histology     during colonoscopy and to determine the appropriate therapeutic strategy. This is important     in clinical practice, since adenomas or superficial invasive submucosal carcinoma lesions can     be curatively treated by endoscopic removal, unlike deeply invasive carcinomas, which     requires surgery. The Narrow-band imaging (NBI) international colorectal endoscopic (NICE)     classification is validated classification system proposed as a valid tool for not only     differentiating hyperplastic from adenomatous polyps, but also predicting submucosal deep     (SM-d) carcinomas. It was developed based on NBI technology, leaving uncertainty on its     applicability to other systems. It was previously evaluated the application of the NICE     classification to Fujinon spectral Imaging Color Enhancement (FICE) technology founding     suboptimal results (accuracy 77%, sensitivity 77% and specificity 75%) and moderate     inter-observer agreement (kappa: 0.51).   "
12089|NCT03127592|"     This Phase III study will compare the efficacy and tolerability of a Fixed Dose Combination     of Etodolac + Cyclobenzaprine versus the isolated drugs in postoperative pain control after     impacted third molar extraction.   "
9981|NCT03155295|"     The purpose of the study is to evaluate patient-specific surgical simulation by permitting     pre-operative rehearsals, in the form of the surgeon completing a dry run of the procedure on     a model constructed from the patient's radiological studies that replicates every aspect of     their organs. The investigators' aim is to evaluate the effectiveness of this form of     practice in optimizing intraoperative and postoperative outcomes . The investigators hope     eventually to use these rehearsals as a standard study tool for surgical training.   "
9982|NCT03155282|"     Patients with cirrhosis have structural and functional alterations of the liver. The     progressive deposition of hepatic fibrosis is related to the subsequent development of portal     hypertension (PH), and PH is associated with mayor complications including ascites, hepatic     encephalopathy and development of gastroesophageal varices with a high risk of bleeding.     Variceal bleeding is a medical emergency associated with a 6-week mortality rate of     approximately 10-20%. Liver biopsy is the gold standard for the assessment of hepatic     fibrosis, whereas the measurement of hepatic vein pressure gradient (HVPG) is the standard to     evaluate PH and upper endoscopy (UE) is the method of choice to detect the presence and grade     of gastroesophageal varices. The last two also estimates the risk of variceal bleeding.     Unfortunately, clinical investigation of PH implies HVPG measurement or endoscopy for     esophageal varices (EV) screening and grading. The first one is an invasive technique, mainly     restricted to tertiary centers, that requires personal training, increased health care costs     and patient discomfort. The UE, even though has demonstrated utility to predict HVPG (HVPG     value ≥ 10 mmHg predicts the presence of EV and a value ≥ 12 mmHg is predictive for variceal     bleeding), has been criticized of being subjective. Because of this, alternative test     including elastographic techniques, have been develop to assess the severity of PH, the     presence of EVs and the risk of variceal bleeding. Elastography is a technique used to     measure tissue elasticity and stiffness in real time, by the application of slight     compression using a transducer to the targeted tissue. The principle is that tissue     compression produces deformation (strain) and that the strain is smaller in harder tissue as     compared to softer tissue. Consequently, by measuring the tissue strain induced by     compression, it is possible to estimate the tissue hardness. Fibroscan® (FS) (Echosens,     París, Francia) uses the principle of one-dimension transient elastography (TE) for the     assessment of tissue stiffness. It was used initially for liver stiffness measurement (LSM)     and proved to be reliable for the diagnosis of liver cirrhosis and avoid liver biopsy in 90%     of cases. Also LSM by TE accurately correlates with the severity of PH and the presence of     esophageal varices.   "
9983|NCT03155269|"     To investigate the effect of nutritional supplement on bone turnover markers (which are     sensitive and respond quickly to nutrition or drug intervention) in Indian healthy     premenopausal women after 6 months of intervention.   "
9984|NCT03155256|"     Bleeding from gastric varices (GV) is associated with high mortality. Injection of     cyanoacrylate (CYA) using standard gastroscopes has demonstrated higher hemostasis and lower     rebleeding rates compared to band ligation or sclerotherapy. Nevertheless CYA treatment is     known to be associated with significant adverse events. Pulmonary embolism due to CYA     injection is a serious and sometimes fatal complication of this therapy. Romero-Garcia et al.     recently showed that, even these patients usually have respiratory symptom, this complication     can be present in asymptomatic patients and with only CT pathological images showing it. On     the other hand, risk of glue embolism, has been described to be dependent on the volume of     CYA injected, being significantly greater with high volume. Other complications related to     CYA injection are, hemorrhage from post injection ulcers, fever, peritonitis, needle     impaction, and even death. Also the injection material can cause serious damage to the     endoscope.      Currently endoscopic treatments are CYA injection under direct visualization using a standard     gastroscope and treatment under EUS guidance with injection of CYA, coils or both. However,     to date, it is unknown whether one of these techniques is technically more feasible or causes     less adverse events than the other.      Treatment under EUS guidance may improve results because of precise targeting of the varix     lumen or afferent feeding veins. This allows the vein to be obstructed with a small amount of     CYA, less than used for the blind injection of GV with standard endoscopic technique and     may reduce the risk of glue embolism. EUS can confirm varix obliteration by using Doppler.     Also visualization of GV by using EUS is not impaired by blood or food in the stomach and     thus can be performed in the setting of active hemorrhage.   "
9985|NCT03155243|"     This study aims at evaluating real life effectiveness of originator adalimumab (Humira®)     participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU)     despite high-dose corticosteroid therapy; including effect on ocular inflammation,     health-related quality of life, health resource utilization, work ability and medication     burden, as well as describe the characteristics of NIIPPU participants treated with Humira®     in the real-life setting.   "
9986|NCT03155230|"     Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited     from the Danish Hernia Database and cross-checked with hospital files and the National     Patient Registry. A standardized postal questionnaire was sent out two years after the index     surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic     post-operative pain.   "
10000|NCT03155048|"     In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer     (FET) cycles were analyzed. This study was undertaken in the Department of Assisted     Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with     approval of the local ethics committee. The aim of this prospective randomized clinical trial     was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol     transdermal patch.   "
10047|NCT03154437|"     This open-label, multicenter expanded access program (EAP) is designed to provide emicizumab     to eligible participants with hemophilia A with factor VIII (FVIII) inhibitors before it is     commercially available in the United States for the indication of hemophilia A with FVIII     inhibitors. Discontinuation may occur earlier if participant or physician decides to     discontinue treatment or the sponsor discontinues emicizumab clinical development.   "
9987|NCT03155217|"     Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially     thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used     daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy     or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous     rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell     carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and     more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the     over-75-year-old age group is becoming larger. These patients are still active but much more     vulnerable. Nevertheless, there is no data in the literature for this fragile population     except the MM pivotal studies subgroups of those over 65-year-old. The results vary with     different regimens. Therefore, there is a wide lack of information that could help make a     therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK     inhibitors in elderly patients   "
9988|NCT03155204|"     The purpose of this study is to compare the absorption of four different inhalation products     with the reference product in healthy volunteers.   "
9991|NCT03155165|"     Colonoscopy is considered the gold standard for colorectal polyp and cancer detection.     However, even meticulous colonoscopy substantial numbers of colorectal polyps may be missed     and carcinomas may not be prevented. Previous studies have found a 12-28% of miss rate for     all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with the higher miss rates     noted for smaller polyps. The lesions missing rate depends on several factors as the location     on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the     ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, a poor bowel     preparation and inadequate endoscopy technique, particularly rapid colonoscope withdrawal.     Using the commonly available 140º angle of view colonoscope, approximately 13% of the colonic     surface is unseen. The incorporation of colonoscopes with a 170-degree wide angled could not     improve adenoma detection rate. The introduction of high definition (HD) colonoscopes and     visual image enhancement technologies as narrow band imaging (NBI, Olympus America, Center     Valley, PA), i-SCAN™ (PENTAX of America, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy     (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization, but several     studies proved no increase in adenoma detection rates. The Third Eye Retroscope (Avantis     Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced via the     accessory channel of a standard colonoscope. Allows retrograde views behind colonic folds and     flexures simultaneously with the forward view of the colon. Although it was shown an increase     in adenoma detection rate by 11%-25%, it has many disadvantages. It requires a separate     processor and the device is disposable making the cost bigger. Occupies the working channel     of the colonoscope which limits the ability to suction. If a polyp is seen the viewing device     has to be removed in order to perform the polypectomy. The optic is not high definition and     finally, the endoscopist has to get used to visualizing and processing two simultaneous video     streams from the colonoscope and from the retroscope device.   "
9992|NCT03155152|"     Different types of high-intensity interval training (HIIT) sessions are used by athletes in     order to improve their physical performance, but innovative approaches to training are     lacking. Therefore, in Part A of this study the physiological response to a standard HIIT and     a new decremental exercise training (DECT) will be compared in runners and cyclists. Next, in     Part B the training effects of a 4-week block of the HIIT and DECT will be compared.   "
9993|NCT03155139|"     To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with     hypertension.   "
9994|NCT03155126|"     The goal is to observe that the incidence of acute kidney injury in patients who need fluid     resuscitation when resuscitated with saline or acetated Ringer's sodium.   "
9995|NCT03155113|"     Anti-viral, hepatitis C virus (HCV)-specific immune T cell responses are functionally     defective in patients with chronic hepatitis C and this functional impairment is believed to     contribute to virus persistence. Persistent exposure to high virus loads is likely involved     in the pathogenesis of T cell dysfunction. The underlying hypothesis of the project is that     the level of anti-viral immune dysfunction in chronic HCV infection is a causal factor which     can influence non-response to therapy.      Although the rate of response to direct anti-viral agent (DAA) therapy, in untreated,     non-cirrhotic, patients is between 95% and 100%, however, the response rate is lower in     specific subgroups of patients, including genotype 3 cirrhotics and patients with     decompensated cirrhosis, irrespective of the infecting genotype.      Aim of the present study will be thus to understand whether non-response to therapy is     associated with a wider and deeper anti-viral immune dysfunction, by comparing individual     HCV-specific T cell responses in two groups of responder and non-responder patients.     Characterization of protective immunity in non-responder patients could allow to identify     baseline predictors of non-response to therapy to be used in the daily clinical practice.      Objective of the study will be to compare the features (intensity and quality) of the overall     HCV-specific immune T cell response in patients non-responder and responder to DAA therapy.     To achieve this goal, T lymphocytes (either CD4 or CD8) isolated from the peripheral blood of     the patients, before starting DAA therapy, will be stimulated with HCV proteins to evaluate     the capacity of those cells to expand, produce cytokines and express cytotoxic capacity.   "
9996|NCT03155100|"     The main aim of this study is to assess the ORR with a new drug combination, carfilzomib     (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex).   "
9997|NCT03155087|"     Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice     treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11     and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and     STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy     among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM     patients and healthy subjects.   "
9998|NCT03155074|"     The HILT study is a prospective, single-blinded, randomized controlled trial comparing a     high-intensity exercise training intervention with usual care among adult lung transplant     recipients. Patients randomized to the training intervention arm will undergo individually     tailored high-intensity exercise training (80-95% of maximum heart rate) three hours per week     for 20 weeks. Training will be conducted at local fitness centers on a one-on-one basis.   "
9999|NCT03155061|"     The objective of the study is to evaluate the safety, tolerability, pharmacokinetics,     efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with     advanced or metastatic solid tumors.   "
10001|NCT03155035|"     Soil Transmitted Helminths (STH) are among the most common infections in the world today. The     World Health Organization (WHO) recommends mass administration of deworming medicine as a     single routine annual dose to all school age children (SAC)(age 5-16 years) in countries     where prevalence of Soil Transmitted Helminthic Infections (STHI) is > 20% as a safe public     health intervention that promotes healthy growth (Category 2 Recommendation). Pakistan is     classified as a low burden community with a reported prevalence of STHI <50%, however,routine     deworming is not a policy in Pakistan. Currently, Pakistan is also facing a huge burden of     malnutrition in all age groups especially in population belonging to low socioeconomic group.     Incidentally, worm infestation by STH also occurs in this group due to associated lack of     hygiene and poor living conditions. The coexistence of even moderate STH infections can cause     or aggravate malnutrition. The urban slums of Karachi provide environmental, social and     behavioral conditions that favor both STH infections and a risk of under nutrition. It is     unknown if administering routine dose of deworming medicine to SAC as per WHO recommendation     will contribute to improvement in indicators of nutrition status in Pakistani children living     in urban slum conditions by eliminating worm infection.Therefore, this study is being     conducted to determine the effect of deworming on weight of School Age Children aged between     5 to 16 years.   "
10265|NCT03151590|"     The purpose of this prospective intervention study is to find biomarkers and underlying     pathomechanisms for non-response of improvement in glucose metabolism to exercise.      An additional goal is to identify non-responders at an early stage, where prevention     strategies (pharmacologically or by specific training) will be successful.   "
10002|NCT03155022|"     Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the     combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning     (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of     these two interventions may improve clinical outcome after STEMI remains unknown. The     objective of the present study is to determine whether combination of ICIC and RIC can     improve STEMI patients clinical outcome at 6 months.   "
10003|NCT03155009|"     This study will evaluate the efficacy and safety of alectinib, in selected participants, with     anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC),     after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor,     and eventually chemotherapy treatment(s).   "
10004|NCT03154996|"     The primary goal of this study is to establish, for the first time, safety of prolonged     intracerebral convection enhanced delivery of chemotherapy in patients with recurrent high     grade glioma (HGG). Secondary objectives will include determination of topotecan (TPT)     distribution and radiographic tumor response with prolonged continuous intracerebral     convection-enhanced delivery (CED).   "
10005|NCT03154983|"     The purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate Tablets     combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer.   "
10006|NCT03154970|"     This study will be performed in people with obstructive sleep apnea, in which one group will     receive treatment with cervical stabilization for six weeks and the control group will     receive treatment after the interval of six weeks   "
10007|NCT03154957|"     The analysis of professional practices in the emergency department of the Strasbourg CHRU in     the management of acute shoulder dislocations aims at proposing a clinical pathway of     synthesis taking into account current practices and data from the literature. Thus, the     objectives are twofold: first standardize care in emergency rooms and try to improve the weak     points of this care.The Investigators will concentrate thier observation work on the     medicinal analgesic methods proposed to these patients in order to minimize the pain induced     by the external reduction maneuvers performed, in the majority of cases, in the emergencies.     This work will ultimately have a real clinical impact on the management of these traumatized     patients   "
10008|NCT03154944|"     This investigation evaluates three new ostomy appliances and their impact on the peristomal     skin.   "
10009|NCT03154931|"     The purpose of this study is to determine the efficacy of a 8-week program of Compassion     Focused Therapy in Group comparing to Supportive Cognitive Behavioral Therapy in Group for     patients with Posttraumatic Stress Disorder.   "
10010|NCT03154918|"     This study is to explore the efficacy and safety of GLIDE regiment in patients with     aggressive NK/T cell lymphoma.   "
10011|NCT03154905|"     The digestive system may be involved in various pathologic conditions, with different     inflammatory, metaplastic and neoplastic aspects. As the therapeutic tool-box for digestive     diseases grows and becomes more focused, at times targeting specific molecules, decision     making in managing patients becomes more and more important, and must be evidence based.      Defining biomarkers with predictive value will theoretically allow physicians in making     diagnosis, deciding on a suitable first line therapy (with specific endpoints suggesting     response or indicating 2nd line therapy is indicated) and finally may suggest surgical     intervention is warranted, thus forming an individually tailored treatment for each     patient. These biomarkers may be located in the peripheral blood, in the gastrointestinal     tract in general, or confined to specific intestinal lesions.      Chitinase 3-like 1 protein (YKL-40) is produced by different tissues (e.g. - synovium, smooth     muscle, intestinal epithelium). Its specific action is unknown, but several reports have     described it in different inflammatory conditions including those involving the     gastrointestinal system. Chitinase 3 like-1 protein (YKL-40) has also been studied for its     possible role in angio and onco-genesis.      This study aims to evaluate the diagnostic and prognostic value of peripheral and tissue     Chitinase 3-like-1 (YKL 40) levels in gastrointestinal and liver diseases.   "
10012|NCT03154892|"     The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to     frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial     growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，its role in regression of other     neovascular disorders such as wet-type age-related macular degeneration and diabetic     retinopathy has been described. Investigators aim to evaluate the efficacy and safety of     intracameral and intravitreal injection of conbercept for the treatment of NVG.   "
10013|NCT03154879|"     The investigators examine the prognostic value of continuous electroencephalography on     frontal area of brain according to time by performing amplitude-integrated     electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia.   "
10578|NCT03146637|"     This is a phase II Randomized comparison clinical trial of PD-1 inhabitor activated CIK armed     with anti-CD3-MUC1 bispecific antibody for advanced liver cancer. And the aim of this     research is to study the clinical efficacy and safety of PD-1 activated CIK armed with     anti-CD3-MUC1 bispecific antibody for liver cancer.   "
10015|NCT03154853|"     The purposes of these studies are to investigate:      Differences in abductor hallucis muscles'EMG activities during different postural tasks     between individuals with normal foot alignment and functional flat foot. Differences in     abductor hallucis muscles'H-reflex amplitudes between individuals with normal foot alignment     and functional flat foot. Changes in abductor hallucis muscles'EMG activities during     different postural tasks after a 3-week short foot exercises training regimen in individuals     with functional flat foot. Changes in abductor hallucis muscles'H-reflex amplitudes after a     3-week short foot exercises training regimen in individuals with functional flat foot.     hypotheses: Peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis     anterior muscles during different postural tasks were significantly lower in individual with     functional flat foot when compared to those with normal foot alignments. H-reflex amplitudes     of abductor hallucis muscles were significantly lower in individual with functional flat foot     when compared to those with normal foot alignments. Changes of peak-to-peak amplitudes and     ratios of abductor hallucis muscles and tibialis anterior muscles during different postural     tasks were significantly different in individuals with functional flat foot after a 3-week     short foot exercise training regimen. Changes of H-reflex amplitudes of abductor hallucis     muscles were significantly different in individuals with functional flat foot after a 3-week     short foot exercise training regimen   "
10017|NCT03154827|"     This study will test the safety and effectiveness of a combination of investigational new     drug called BL-8040 and atezolizumab to find out what effects, good or bad, this treatment     has on medical condition. Atezolizumab is manufactured by Roche and is approved by FDA for     other indications while BL-8040 is in late stages of clinical development. This is an     investigational study. Approximately 60 patients will take part at multiple centers     worldwide. It is an open-label study, which means that both subjects and the doctors will     know which treatment you are receiving. All participants in the study will receive the     investigational drug, BL-8040, both alone and in combination with atezolizumab. In other     words, there will be no placebo (dummy drug).      The duration of the treatment period of the study will be up to 2 years and will be followed     by one year safety follow up. The study will consist of:        -  a screening period of 21 days to allow your doctor to assess your suitability for          enrollment into the study        -  a treatment period of combination regimen of 21 day cycles for up to 2 years        -  a follow-up period of up to 30 days after completion of combined treatment with BL-8040          + Atezolizumab        -  an additional follow up period for up to one year after the completion of the treatment   "
10018|NCT03154814|"     Retrospective study determine whether ulinastatin enhances postoperative pulmonary     oxygenation after cardiopulmonary bypass (CPB).   "
10019|NCT03154801|"     This study aim to ensure that the implementation of a paramedical screening program and     counseling in sexual health of patients with neurological pathologies (low-grade gliomas and     Multiple Sclerosis) improves their sexual health.   "
10020|NCT03154788|"     The primary aim of this study is to develop and evaluate three short corporate falls risk     awareness videos of approximately 1-2 minutes (each) by using the feedback from     community-dwelling people aged 50 years and above. The three videos aim to make a broad     audience aware of the risk of falling as one gets older.   "
10021|NCT03154775|"     This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy     of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).   "
10022|NCT03154762|"     INTRODUCTION: Asthma is a disease characterized by inflammation of the airway and secondary     contraction of smooth muscle. Treatment for the crisis consist in the use of local and / or     systemic bronchodilators and anti-inflammatories, and it has been shown that mechanical     ventilation to the airway through non-invasive positive pressure ventilation (NIPPV)     decreases bronchial hyperreactivity and contractility of smooth muscle.      OBJECTIVES: To assess the effect of nocturnal NIPPV on local inflammation, systemic     inflammation and the state of hypersensitivity in patients with asthma attack.      MATERIALS AND METHODS: We will include patients with severe asthma attacks requiring     hospitalization, without indication for acute NIPPV, and will be randomized to receive NIPPV     with an spontaneous (S) bilevel or continuous positive airway pressure (CPAP, control group),     all patients will receive standard treatment; gasometric exchange, local inflammation (FEV1     and Exhaled fraction of nitric oxide), systemic inflammation (C reactive protein, IL-4, IL-5,     IL-13 and IL-17 in peripheral blood) and the hypersensitivity state (eosinophilia and IgE)     between both groups will be compared after 4 days of treatment.   "
10023|NCT03154749|"     Both TC (docetaxel/carboplatin) and EC followed by T (epirubicin/cyclophosphamide followed by     docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been     recommended by NCCN guideline. It is unknown which regimen is better. This study is to     evaluate the efficacy and safety of TC (docetaxel/carboplatin) and EC followed by     T(epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment in     Triple-Negative breast cancer. The endpoint of pathologic complete response is used as a     surrogate marker for survival. Safety and tolerability assessed by number of grade 4     toxicities and hospitalizations.   "
10024|NCT03154736|"     Cardiovascular disease is the leading cause of death in the world. 17.5 million people died     in 2012 due to a cerebrovascular disease (31% of all causes of death). In Europe more than     50% of deaths are due to cardiovascular disease. The mortality rate for cardiovascular     disease is higher in the lower socio-economic levels. Three-quarters of deaths from     cardiovascular disease occur in developing countries. According to estimates in 2030,     cardiovascular disease will be responsible for more deaths than the sum of infectious,     nutritional, maternal and perinatal diseases in developing countries.      Measures to prevent cardiovascular risk factors have been shown to be effective.      The lack of an adequate primary care network in developing countries limits the screening and     treatment of patients with cardiovascular risk factors. As a result, these patients do not     benefit from adequate prevention, are diagnosed late and remain disabled or die at a young     age, resulting in significant additional costs for families but also at the macroeconomic     level.      Interventions are possible on a large scale (policies against tobacco and adverse dietary     behavior, promote physical activity, etc.). Actions are possible on an individual level, both     in primary prevention (control of cardiovascular risk factors) and secondary prevention,     where many treatments have proved their effectiveness. These interventions are effective and     cost-effective from a macroeconomic perspective. It was estimated that the cost of such     interventions would not exceed 4% of health expenditure in developing countries and 1-2% in     rich countries.      The World Health Organization insists on the importance of the triad composed by the patient     and his family, community and health professionals. Results are possible only when these     three components work together for the same purpose. Numerous studies show the benefit of the     involvement of patients in their care in the rich countries and in the developing countries.   "
10025|NCT03154723|"     Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and major cause of     vision impairment or blindness, despite current treatment of late stage ROP. Because the     visual disorders after treatment are often poor, preventive therapy for ROP is still lacking.     Although ROP is a multifactorial disease, the altered regulation of vascular endothelial     growth factor (VEGF) and insulin-like growth factor (IGF-1) have been implicated in the     pathogenesis of ROP. Vitamin A is one of the most important micronutrients affecting the     health of children. Supplementing newborn infants with vitamin A within the first 2 days of     life reduced infant mortality by almost 25%, with the greatest benefit to those of low birth     weight. Vitamin A has been used in this population prophylactically for chronic lung disease     with the large doses and no reported significant adverse effect exists. It is suggested that     vitamin A-retinoids and their active metabolite, retinoic acid (RA) have highly potent     antiangiogenic activity by inhibiting VEGF expression. Vitamin A (retinol) is converted into     retinoic acid in cells. However, the significance of Vitamin A administration has not been     investigated to our knowledge in an experimental ROP infant. The aim of this study was to     perform prospective, multicenter, randomized design to demonstrate the preventive effect of     Vitamin A on ROP.   "
10266|NCT03151577|"     To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma     patients undergoing glaucoma surgery.   "
10267|NCT03151564|"     The goal of this clinical research study is to compare imaging software and 2 different     radiation doses during a standard CT scan in order to see problems in the liver and still     produce a good image quality.   "
10026|NCT03154710|"     Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new     cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance     in elderly subjects.      With the continuous improvement of the diagnostic techniques and the treatments, the     prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most     often within 2 or 3 years after the end of treatment.      The current standard follow up includes a clinical examination and a biological check-up     every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months.     However, the interest of this systematic surveillance by imaging is controversial.      The use of new information and communication technologies, can improve the clinical follow-up     of patients. To date, access to the Internet and portable technologies is sufficiently broad     and democratized to envisage the use of this type of remote surveillance in the field of     health. In particular to facilitate the dissemination of information between the patient and     the physician. It is thus possible to imagine using this flow of information to generate     alerts.      Strengthening the clinical follow-up in this indication, in which routine imaging has not     demonstrated their interest, in particular by the implementation of remote monitoring     completed by the patient, may present an advantage in terms of effectiveness and precocity of     care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the     vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by     imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures     for a relatively low benefit, is performed in symptomatic patients since several weeks.      The aim of this study is to evaluate the interest of a web-mediated follow up using a score     based on the dynamics and the association of clinical and biological signs to alert the     physician of a possible recurrence of the patients treated for a lymphoma in complete or     partial response.   "
10027|NCT03154697|"     This database will be used to better understand the sleep problems of people with SMS. This     clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an     awareness campaign around SMS and the sleep disturbances that are characteristic of the     disorder.   "
10028|NCT03154684|"     The primary purpose of this study is to test if the STARK comprehensive autonomy health care     package improves lower extremity function over time at 6 weeks, 3, 6 and 12 months after hip     fracture compared to the standard of care.   "
10029|NCT03154671|"     A multicentre two-group parallel single-blind (outcome assessor) randomized controlled trial     (RCT). A cost effectiveness study alongside a clinical trial using a payer and societal     perspective to study the cost-effectiveness of geriatric assessment and management compared     to usual care will be conducted.      Participants allocated to the control group will receive usual oncology care. Participants     allocated to the intervention group will receive a comprehensive geriatric assessment and     management in addition to their usual oncology care. The intervention will take 6 months to     be completed. Total study follow-up will be 12 months for each participant.   "
10030|NCT03154658|"     This is a randomized, interventional prospective study. Patients (n=66) undergoing     mastectomies with or without tissue expander will be randomized to receive a supra-serratus     or sub-serratus regional plane block prior to surgery. The main effect to be measured is     total opioid consumption 24 hours after the operation. Secondary endpoints include measuring     a change between pre-and post-operative pain scores, patient satisfaction of pain control     during first 24 hours after the operation, presence of postoperative nausea and vomiting,     duration of sleep on first postoperative night, and block performance time and length of     stay, between the two treatment arms.   "
10031|NCT03154645|"     This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention     of acute mountain sickness. These drugs have never been directly compared for efficacy. The     study population is hikers who are ascending at their own rate under their own power in a     true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and     Bancroft Station (BAR), Bancroft Peak, White Mountain, California.   "
10032|NCT03154632|"     The main objective:      To compare the effect on muscle tone between the application of digital capacitive diathermy     and the application of ultrasound on the myofascial trigger points (MTP) of the upper     trapezius muscle.      Hypothesis:      The application of digital capacitive diathermy on myofascial trigger points of the trapezius     muscle compared to the application of ultrasound produces objective changes in muscle tone,     and this change is superior to the changes generated by the US.   "
10033|NCT03154619|"     The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of     chronic venous insufficiency ulcers has been established. This study is designed to determine     the most efficient method of treatment.   "
10034|NCT03154606|"     The investigators propose a randomized, tightly-controlled breakfast trial in normal to     overweight adults that will test whether the consumption of various types of protein-rich     meals, containing ~24g of protein, will differentially alter food intake and meal initiation     through proposed appetite and satiety mechanisms.      Aim 1: To examine whether the consumption of protein-rich meals that vary in protein quality     (source) effect:        1. postprandial feelings of hunger, fullness, desire to eat, prospective food consumption        2. postprandial fluctuations in key appetite and satiety hormones        3. eating initiation (i.e., motivation to eat (again))        4. food cravings      Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality     (source) effect:        1. energy intake and food choice within the breakfast meal        2. energy intake and food choice at the next eating occasion        3. energy intake and food choice across the entire day   "
10579|NCT03146624|"     OBJECTIVE to evaluate patients satisfaction of obturator with attachment versus conventional     obturator in treatment of unilateral maxillectomy .   "
10580|NCT03146611|"     Neutrophil CD64 versus Neutrophil/Lymphocyte ratio (NLR) as markers predicting in-hospital     outcome in acute exacerbation of COPD   "
10035|NCT03154593|"     Persistent swelling (chronic oedema), e.g. of the legs, is quite a common condition, which     can cause a number of problems, including infections (cellulitis) in the swollen area and     ulceration. It seems to be particularly common in people who are overweight but this has not     been studied in detail. This study aims to address this gap in knowledge. It will take place     in two stages, running in parallel to each other with different groups of patients. The first     stage will determine how common persistent swelling is among patients attending weight     management services at the Royal Derby Hospital and how it impacts on every day life. The     second stage will determine whether weight loss surgery improves the swelling.      The results will inform future treatment guidelines for overweight patients who have     swelling. They will also inform the design of future research that will investigate the     effects of weight loss surgery in more detail, for example by testing out methods of     measuring fluid changes in the legs.      All new patients attending the weight loss service will be eligible to take part in the first     stage of the study, as long as they: give their informed consent to take part, and can speak     English (or have someone with them who speaks English). Participants will not have had weight     loss surgery previously. The Stage 1 assessment is expected to take about 40 minutes and     consists of: a single clinical assessment for each participant to identify the presence of     the swelling and its degree in each of the affected areas and, up to 3 questionnaires     concerning their quality of life and mobility.      Patients attending the programme, who have been referred for bariatric surgery, will take     part in the second stage of the study. Stage 2 will last approximately 13 months, during     which time the participants will be assessed 4 times - once before surgery and at 3, 6, and     12-month intervals after surgery. Each Stage 2 assessment is expected to take about 50     minutes and consists of: a clinical assessment and up to 5 questionnaires.   "
10038|NCT03154554|"     Lumbar pain is an extremely common complaint in general population. The direct and indirect     costs incurred in are a real public health problem.      Cohort studies show that improving symptoms after consultation for lumbar pain is     insufficient, but there are few data on emergency medical and surgical services in France. In     order to reflect on areas for improvement the investigators to carry out an inventory of     consultations for lumbar pain emergencies of Hautepierre Hospital.   "
10039|NCT03154541|"     Assess if the use of SYNRINSE can improve short-term subjective and objective outcome     measures after one week in patients with active Chronic Rhinosinusitis (CRS) who have had     prior sinus surgery.   "
10040|NCT03154528|"     Androgenetic alopecia is a common form of diffuse hair loss in both men and women,It     primarily affects the top and front of the scalp with different clinical presentations and     there are numerous classification systems for grading purposes.   "
10041|NCT03154515|"     The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective     and safe for the treatment of influenza and other laboratory confirmed acute respiratory     viral infections in the course of standard therapy in patients 18-60 years old.   "
10042|NCT03154502|"     This study is aim to determine the sodium intake in Ecuadorian population that is an unknown     information at present. For that, 24h urine samples will be collected from 130 subjects     working either at tue USFQ or HDLV to measure sodium excretion.   "
10043|NCT03154489|"     The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate     the control of patients under treatment with coumarin anticoagulants, increasing their safety     and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics     and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the     impact of the Program of medication review with follow-up in collaboration with doctors and     nurses in primary care improves the degree of control of the patients under treatment with     coumarin anticoagulants. Method: a randomized, controlled study for the main objective.     Population and scope of study: Patients on treatment with coumarin anticoagulants with time     in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up     from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each     patient will be followed by a period of 6 months. After this period, patients in the control     group (CG) will receive the service of medication review with follow-up for a period of time     equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result:     Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the     use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of     patients and professionals involved. Statistical analysis and sample size: 204 patients.     Multivariate analysis will be used and cost-effectiveness..   "
10044|NCT03154476|"     The purpose of this study is to determine if the medication, sildenafil (also known as     Revatio), can slow or stop the progression of liver disease in patients who previously had a     Fontan operation.   "
10045|NCT03154463|"     This study aimed to compare the efficacy three-point Transversus Abdominis Plane (TAP) blocks     with continuous epidural infusion for alleviating pain post-laparoscopic nephrectomy   "
10046|NCT03154450|"     Motor neurone disease is a progressive incurable disease causing weakness and paralysis of     muscles. Respiratory failure is the most common cause of death in motor neurone disease.     Patients with respiratory failure use a machine that supports breathing using a mask and     ventilator (non-invasive ventilation: NIV) and using it for more than five hours per night     has been shown to prolong life and improve symptoms such as poor sleep and breathlessness.     NIV is however, challenging to use and some patients are unable to adhere to the required     regime meaning they fail to gain benefit. Timely support is important to help individuals     overcome early hurdles and barriers to using becoming regular NIV users.      The Philips EncoreAnywhere is a system that allows continuous monitoring of the use and     effectiveness of ventilation and allows instant adjustment of ventilator settings. The aim of     this project is to explore if real time feedback and support, as well as remote changes to     NIV settings using the EncoreAnywhere system could increase the number of individuals     successfully using NIV. This project also aims to explore the impact of using EncoreAnywhere     on the process of initiation of NIV, on both patients and staff.      Patients starting NIV at the Sheffield MND care centre will be provided with the standard     ventilator plus a Philips modem for the first three months of use. In half the patients     clinicians will be able to use the EncoreAnywhere system to review patients' use of NIV, make     adjustments and give feedback. In the other half, the data will be collected but not     available to the clinical team. Clinical data will be collected as part of usual care:     adherence, clinical encounters and resource use and patients will be asked to complete     questionnaires at baseline, one month and three months. This will allow the care team to     predict the potential impact on the service and on clinical care. This is a small pilot,     feasibility study, and if the study is deemed feasible, a further larger randomized     controlled trial is planned. The study will last for a maximum of 12 months, recruiting up to     40 patients.   "
25215|NCT02955628|"     This is a multicentre, open-label, phase II study of ibrutinib 560 mg in combination with     R-ICE for treatment of transplant-eligible relapsed/refractory diffuse large B-cell lymphoma.   "
10048|NCT03154424|"     A single center, parallel group, prospective, randomized clinical trial was conducted at the     department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital,     Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius     fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®,     Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).   "
10049|NCT03154411|"     The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to     detectable signals (defined as signal-to-noise ratio, SNR ≥10, with the Odyssey NIR scanner     in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining and     compare SNR to tissues with an EGFR pathology score < 1).      The secondary study objective is to assess if the spatial patterns of EGFR expression     correlate with the tumor targeting of ABY-029 detection by NIR scanner relative to     histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as     the gold standard, and to measure the molecular uptake and concentration of ABY-029 in     resected specimens.   "
10068|NCT03154164|"     The present study aims at analyzing the learning curve for fundus first with the ultrasonic     tissue coagulation dissection technique in elective cholecystectomy. Patients included in the     study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All     participating surgeons have experience of the traditional approach with electrocautery. The     operation time as well as the surgeons own evaluation of difficulty and performance are     noted. Selected films are analyzed by independent surgeons with experience of the fundus     first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to     record the intra and postoperative complication rate.   "
12126|NCT03127046|"     To evaluate the drug-drug interaction between aceclofena and esomeprazole   "
10050|NCT03154398|"     Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality     of life, and on morbidity and mortality through the complications that affect the small and     large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease     has been emphasized by the findings of the national commission (USA) on diabetes .      So, there was curiosity to understand and learn the association of this disorder with another     common endocrine gland function that is thyroid gland . The association between these two     disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic     population varies widely between studies. With insulin and thyroid hormone being intimately     involved in cellular metabolism and thus excess or deficit of these hormones result in     functional derangement of the other .      Diabetic patients have higher prevalence of thyroid disorder when compared with the normal     population. Diabetic women are more frequently affected than men and hypothyroidism is more     common than thyrotoxicosis.      As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may     increase susceptibility to hypoglycemia thus complicating diabetes management so Severe     diabetic complications where noted in patients with sub- clinical hypothyroidism .     Sub-clinical hypothyroidism is an independent risk factor for development of diabetic     nephropathy.   "
10051|NCT03154385|"     Previous studies have shown that increase level of BAFF could promote the settlement of     long-lived plasma cells in the spleen of ITP patients treated with anti-CD20. This     single-center prospective pilot study, currently in phase IIa, will evaluate the efficacy of     a rituximab and belimumab sequential combination treatment. Investigators plan to include 15     patients with persistent ITP over a 24-month inclusion period. Each patient will be followed     for 1 year   "
10052|NCT03154372|"     Purpose:      The aim of this study was to compare the effects of deliberate vs. self-guided practices on     acquiring needling skills by novice learners.      Methods:      Eighteen medical students were randomized to deliberate or self-guided practices groups.     Following a learning phase, subjects attempted to perform a predefined task, which entitled     advancing a needle towards a target on a phantom gel under ultrasound guidance. Subsequently,     all subjects practiced performing the task using previously validated metrics. Subjects in     the deliberate practice group were coached by an expert anesthesiologist and practiced each     metric until it was satisfactorily performed based on the supervising anesthesiologist     assessment. Immediately after completing the practice, all subjects attempted to perform same     task, and on the following day, made two further attempts in succession. Two trained     consultant anesthesiologists will use the metrics to independently score the video-recorded     performances.   "
10053|NCT03154359|"     The primary aims of this study focus on characterizing the relationship between atomoxetine     exposure and clinical outcomes, as assessed by standardized measures. We will also     simultaneously monitor side effect of atomoxetine, another measure of clinical outcomes, and     categorize study participants on their ability to tolerate atomoxetine.   "
10054|NCT03154346|"     This study is the first initiative of Project Baseline, a broader effort designed to develop     a well-defined reference, or baseline, of good health as well as a rich data platform that     may be used to better understand the transition from health to disease and identify     additional risk factors for disease. Project Baseline endeavors to test and develop new tools     and technologies to collect, organize, and activate health information.   "
10055|NCT03154333|"     Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility     of the skin and mucous membranes resulting in painful blisters and erosions after minor     trauma. The simplex form is classified by skin blister development in the basal and     suprabasal epidermis. Diacerein 1% Ointment is a topical ointment that is being developed for     the treatment of EBS with the potential to block activity of interleukin-1β (IL-1β), a     pro-inflammatory cytokine, and reduce the auto-inflammatory effects in the skin of patients     with EBS. The purpose of this study is to compare the efficacy of Diacerein 1% Ointment to     Control Ointment when applied once-daily for 8 weeks in subjects with EBS.   "
10056|NCT03154320|"     This is a randomized, unblinded study comparing standard vs. same-day treatment for patients     with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred     patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment     group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti.     The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve,     and who present with symptoms of TB (cough, fever, nights sweats, or weight loss >10%) at HIV     diagnosis.   "
10076|NCT03154060|"     On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring     (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes     convention. Making this the only way to receive the device in Belgium. Since then, many type     1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper     arm too visible. Abbott does not recommend to place the sensor on a different place of the     body than the back of the upper arm, because no tests were done yet (besides on the upper     arm) to make an accuracy claim. With this study, we want to evaluate the accuracy and the     precision of the Freestyle Libre FGM by using three FGM sensors simultaneously on different     places of the body and perform regular self-monitoring of blood glucose (SMBG) tests.   "
10057|NCT03154307|"     Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low     frequencies (LF) with the intent to reduce the occurrence of seizures over time. Seizure     reduction and improvements in the quality of life in patients with epilepsy will be     associated with increased cortical inhibition resulting from the LF-rTMS sessions over time.     This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and     painless method for noninvasive focal cortical brain stimulation, which will be evaluated in     its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in     patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location     of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.).     With the same rTMS modality, we will also perform motor threshold mapping in conjunction with     its fully integrated and compatible electroencephalography (EEG) module. Up to 100     individuals 18 to 80 years with epilepsy will be enrolled.   "
10058|NCT03154294|"     This is an open-label, cohort study to determine the feasibility and tolerability of the     combination of TAK-228 and TAK-117 given on days 2-4, 9-11, 16-18, and 23-25 with paclitaxel     on days 1, 8, and 15 for one 28-day cycle in patients with advanced solid tumors.   "
10061|NCT03154255|"     Alongside efforts in public health and policy to reverse the childhood obesity epidemic,     medical providers seek to play effective roles in prevention and treatment. Limited     interventional studies with effective long-term maintenance of weight loss in children are     available. Moreover, interventions should focus on modifying lifestyle, by improving also     ludic educational training. In fact, the knowledge, attitudes, behaviors and skills developed     through effective health programs may result in a better quality of life and empower children     to make correct choices to promote the health of the individual the family and the community.     For this reason, in a cohort of obese pediatric subjects with visceral adiposity, the aim of     the study is to assess the efficacy of an educational training inspired to Mediterranean diet     and based on gamification (as The Mediterranean Goose) with respect to a conventional     treatment on weight loss and improvement of cardio-metabolic risk factors.   "
10062|NCT03154242|"     This Study evaluate the effect of Polymorphism in the Excision repair cross-complementing     group 5 (ERCC5) (rs1047768 and rs751402) gene on the clinical outcome of Platinum-based     regimens used in the treatment of Non-Small Cell Lung Cancer (NSCLC) patients   "
10063|NCT03154229|"     The study hypothesis is that clinical decision-support on a smartphone for the management of     diarrheal disease will improve the assessment of dehydration, reduce IV fluid usage, and     increase guideline adherence for the use of zinc and antibiotics. To test this hypothesis we     will conduct a cluster randomized controlled trial in the diarrhea wards of 10 hospitals in     Bangladesh. A 6-week pre-intervention period will establish a baseline at all sites, and in     the intervention, hospitals will be randomized to use a paper versus smartphone adaptation of     the WHO guidelines by the admitting physician. Inclusion criteria are patients 2 months and     older that have uncomplicated acute diarrheal disease; estimated enrollment is 7893 patients.     The primary outcome measure is use of IV fluids. This project may have broad impact that will     include opportunities to provide improved decision-support for the assessment of dehydration,     decreased use intravenous fluids and more prudent use of antibiotics.   "
10064|NCT03154216|"     Fasting blood fat levels (triglycerides) are often used to assess risk of heart disease but     the level of fats in the blood after a meal is actually a stronger risk factor. Most of our     day is spent digesting the food we eat (which takes hours). Therefore, after meal blood fat     levels have more of an impact on formation of blockages in our arteries and our risk of heart     disease compared to fasting blood fat levels. Exercise performed hours before a meal     reduces the level of fats that appear in the blood after a meal and can be used to reduce our     risk of heart disease. Exercise has this effect because muscle burns fats for hours after an     exercise session is over; this helps to remove fats from the blood. Unfortunately, when     high-sugar drinks (such as Gatorade) are consumed after exercise, the possible benefits of     exercise for reducing blood fat levels after meals is lessened. This is because high-sugar     drinks stimulate the release of insulin into the blood. Insulin is a hormone which inhibits     fat burning at the muscle. Previous research we did showed that foods that result in a slower     rise in blood sugar and lower release of insulin preserve the beneficial effects of exercise     for lowering blood fat levels after the next meal. Milk also results in a slow rise in blood     sugar and low release of insulin; therefore, it may also have this beneficial effect if     consumed as a recovery beverage after exercise. Our proposed research will test the effects     of consuming two popular exercise-recovery drinks (Milk vs. Gatorade) on the rise in blood     fat levels after a meal given hours later. A total of 20 obese or overweight participants     will take part. We predict that milk consumed after an exercise session in the evening will     result in a lower increase in insulin, a greater amount of fat-burning at muscle and a lower     blood fat level after a meal given the next morning. Milk and Gatorade are both promoted as     good beverages to promote recovery after exercise. This study will provide evidence about     milk as a healthier choice compared to Gatorade and will allow dairy producers to promote     health benefits of dairy products.   "
10065|NCT03154203|"     This study is a sub-investigation of SAFAR study. Consecutive patients with established     hypertension (treated or untreated with antihypertensive drugs) or with suspected     hypertension are recruited and their 24-hour brachial and aortic blood pressures,     cardiovascular risk factors and target organ damage are assessed. And the participants'     target organ damage, cardiovascular events, cardiovascular and overall mortality will be     followed four years later.   "
10066|NCT03154190|"     This randomized pilot clinical trial studies health care coach support in reducing acute care     use and cost in patients with cancer. Health care coach support may help cancer patients to     make decisions about their care that matches what is important to them with symptom     management.   "
10077|NCT03154047|"     The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in     subjects with AL amyloidosis who have completed Study NEOD001-201.   "
10078|NCT03154034|"     The purpose of this study is the evaluation of cardiac and pulmonary response to     cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment     (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment).     The study is conducted as a prospective, observational, single-center study. Patients     suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred     to the University Hospital of Regensburg, Germany, for further diagnostic procedures and     heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized     stress echocardiography as well as ergospirometry. Additional detailed assessment will be     conducted including standardized questionary, clinical examination, transesophageal     echocardiography and measurement of biomarkers.   "
10067|NCT03154177|"     The focus of this work is to improve antenatal care (ANC) and postnatal care (PNC) at the     health center level in five districts in Rwanda (Bugesera, Burera, Nyamasheke, Nyarugenge,     and Rubavu). 36 health centers in these districts are included in this cluster randomized     control trial (RCT) of group ANC and PNC care to measure this alternative model's effects on     gestational age at birth, survival of preterm and low birth weight infants at 42 days of     life, and ANC and PNC coverage. To improve antenatal assessment of gestational age, nurses     will be trained in obstetric ultrasound at 18 health centers. These facilities will also     incorporate pregnancy testing with urine dipstick to be performed by community health workers     in charge of maternal health to facilitate early entry into ANC. This trial will test the     hypothesis that women who participate in this alternative model of group ANC will experience     increased gestational age at birth, as compared to women who receive standard focused ANC.     This study is a collaboration with the University of Rwanda, the Rwandan Ministry of Health     (MOH), the Rwanda Biomedical Center, and UCSF.      The group care model used in this study is Rwanda-specific model developed by a Rwandan     technical working group. The model includes an individual clinical visit for the first     antenatal visit, followed by three group visits spaced about 8 weeks apart throughout     pregnancy and a postnatal group visit at approximately 6 weeks after birth. Women will be     grouped into stable groups of approximately 8-12 women with similar due dates. A community     health worker (CHW) and a health center nurse will work together as co-facilitators to lead     each of the groups. Each group visit includes clinical assessment, education, and treatments     as appropriate for the women who attend. The model is founded on facilitative leadership of     the groups, in which the co-facilitators allow women's experiences and interests to drive the     content and women are encouraged to help one another cope with obstacles to optimal health.     Facilitators will be supported by master trainers who will visit health centers to observe     group sessions and offer supportive feedback.      Data collected in this trial will include measures of the satisfaction of both women and     providers with the group care, content of care differences between standard and group care,     and perinatal outcomes such as gestational age at delivery and 42-day preterm and low birth     weight infant survival.   "
10268|NCT03151551|"     The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab     versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic     disease-modifying anti-rheumatic drugs (DMARD) naive.   "
10069|NCT03154151|"     If you worked or volunteered as a WTC rescue, recovery or clean-up worker after the 9/11     attacks, and you are still experiencing Posttraumatic Stress Disorder (PTSD) symptoms related     to your WTC experience, you might be eligible to participate in this clinical trial of     therapist-assisted, Internet-based (online) writing therapy for WTC responders with     persistent PTSD symptoms. This study is for WTC responders who are not currently receiving     psychotherapy/counseling, and who are not currently taking prescription medication for a     psychiatric or emotional problem. In this study, the researchers aim to find out if     Internet-based therapy can help WTC responders who are still experiencing PTSD symptoms.   "
10070|NCT03154138|"     Postural imbalance after stroke leads to limitations of activity and a worse autonomy. The     postural imbalance is increased in right supratensorial stroke (RSS) compared to left     supratensorial stroke. The evidences for the rehabilitation of postural imbalance are weak.      Likewise, disorders of spatial reference frames are increased in RSS. The postural imbalance     is correlated with the disorders of spatial reference frames in RSS patients.      Prismatic adaptation (PA) is often used for the rehabilitation of unilateral spatial neglect     after RSS. Several studies have demonstrated a peculiar expansion of sensorimotor     after-effects to spatial cognition. An immediate effect of reduction in postural imbalance     have been showed in acute RSS. Therefore, it is interested to investigate the immediate and     delayed effects of PA on the postural balance and the spatial reference frames in chronic RSS     to purpose a new therapeutic approach.      The hypothesis of the study is that PA would improve the postural balance (activity) of     chronic RSS patients by a reduction in mediolateral postural asymmetry, resulting from a      bottom-up  action of PA on spatial reference frames.   "
10071|NCT03154125|"     This is a randomized clinical trial designed to evaluate the effectiveness, safety and     acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment     cycles (12 months) of use.   "
10072|NCT03154112|"     The measurement of how much oxygen a baby consumes provides important information about the     health of the baby, and of how much energy they are consuming. Currently, there is no device     which measures either oxygen consumption, or another variable that depends on oxygen     consumption - resting energy expenditure - in neonates or infants. Our group has developed a     new device which can attach to any ventilator and measures these two variables with accuracy     in the preclinical setting, including in rodents as small as severely preterm infants. The     purpose of this study is to compare measurements of oxygen consumption and energy expenditure     in neonates using this device and comparing it with a gold standard which is rarely used, a     Douglas bag method in which expired gas is collected and later analyzed.   "
10073|NCT03154099|"     the detrimental impact of dysfunction is well recognized. CIRCI may be characterized by any     of the following findings with delayed weaning from mechanical ventilation and hypotension     refractory to fluids and vasopressors being most common Hypotension Unresponsiveness to     catecholamine infusions Ventilator dependence Abdominal or flank pain High fever with     negative cultures and unresponsive to antibiotic therapy Unexplained mental changes (i.e.,     apathy or depression) Electrolyte abnormalities (hypoglycemia, hyponatremia, hyperkalemia)     Neutropenia, eosinophilia   "
10074|NCT03154086|"     This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of     escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a     randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that     will have two parts; Part A and Part B. A total of 64 subjects will be randomized (8     subjects/cohort) to GSK3352589 or matching placebo.   "
10075|NCT03154073|"     The purpose of this study is to compare the effects of moderate versus vigorous intensity     exercise training on glycemic control in older adults. Glycemic control will be assessed     using an oral glucose tolerance test and continuous glucose monitors. In addition, we will     investigate whether engaging in an exercise training program elicits changes in sedentary     behavior, non-exercise physical activity, sleep, and total daily energy expenditure.   "
10079|NCT03154021|"     To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention     of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial     flora and measuring gingival inflammation and bleeding.   "
10080|NCT03154008|"     The current study will examine neurophysiological, specifically event-related potential     (ERP), measures of emotional processing as predictors of response to cognitive behavior     therapy for adolescent depression.   "
10081|NCT03153995|"     The objective of my study will be to assess and compare between two different approaches for     placement of self- inflating osmotic tissue expanders used as preparatory surgery before     alveolar ridge augmentation using autogenous onlay block bone graft.      The assessment and comparison will be based on:        1. Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar           ridge augmentation.        2. Quantity of the soft tissue obtained after soft tissue expansion.   "
10082|NCT03153982|"     The purpose of this study is to assess the safety and efficacy of ruxolitinib in patients     with operable Head and neck squamous cell carcinoma (HNSCC) who are planned for definitive     surgery.   "
10083|NCT03153969|"     The objective of this study is to evaluate the clinical effectiveness of a new composite     resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non     carious cervical lesions Class V lesions.      3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this     study (Group 1). This is a light-activated, flowable restorative composite.      Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is     the second composite that will be used in this study (Group 2) Giomer is a collective term     for dental materials that will release ions, such as fluoride. Results from previous studies     show that the released ions may have beneficial effects on the tooth, including strengthening     the tooth.      In each participant, one tooth with a class V lesion will be randomized to group 1, and a     second tooth with a class V lesion will be randomized to group 2. The restorations will be     observed over 18 months to determine clinical acceptability.   "
10084|NCT03153956|"     A prospective, interventional, randomized, double-arm clinical evaluation study to examine     the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the     long-term at 12 months post-treatment, with the primary efficacy assessment based on     improvement in knee pain score and improvement in function in patients following diagnosis of     knee osteoarthritis (OA).   "
10085|NCT03153943|"     Approximately 35,000 seniors in Canada suffer a hip fracture each year. Hip fractures can     affect a person's health, well-being and autonomy. Personal costs of these fractures are     high, with as many as 50% of patients being unable to return their pre-fracture level of     autonomy.      Homecare and community services provide customary rehabilitation support immediately     following discharge from acute-care, though this contribution can be limited by lack of     resources. For those patients at risk of negative outcomes, we have demonstrated clinically     important benefits of extended exercise rehabilitation programs offered beyond the regular     rehabilitation period on improving physical function.      Through advances in sensor and telecommunication technology, eHealth solutions incorporated     within homecare services as an integral part of the continuum of care can lead to better     patient and health professional experience, improve clinical outcomes and reduce costs to the     healthcare system.      The purpose of this study is to determine if the implementation of a 4-month community-based     extended-rehabilitation e-Monitoring and Coaching support program is more effective at     improving mobility in community-dwelling elderly patients who have sustained a fracture than     a printed material support program, and if these effects persist 6 months after     discontinuation.   "
10086|NCT03153930|"     This study is a randomized crossover trial to compare the effectiveness of interrupting SB on     glucose homeostasis in the lab and free-living settings. All participants (N=56) will     complete one screening visit to determine eligibility, complete at fitness test, and body     composition analysis by bioelectrical impedance. After 7-21 days, all participants will     complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to     the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right     thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous     sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of     moderate intensity walking on a treadmill. There will be a 7-21 day washout period between     the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and     who successfully complete both OGTT visits will complete a second randomized crossover trial     in the free-living environment. The experimental conditions for the free-living components     will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise     breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in     the free-living trial will wear an activity monitor and a continuous glucose monitor.   "
10087|NCT03153917|"     Nonstandard time-schedules work are widespread in the world of work. Shift and night work     have been shown to be responsible for a desynchronization of biological rhythms, associated     with melatonin secretion impairment and sleep disturbances. However, while health     consequences of night and shift work are widely recognized and represent a major public     health concern (High Authority of Health 2012 Recommendations and National Agency for Public     Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system     is affected by shift work remain poorly understood. Indeed most of the studies in the fields     are cross-sectional, based on few blood or urinary samples in a single work position, in     workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few     studies have assessed melatonin secretion alterations in relation to objective sleep     measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin     secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle     recording.   "
10088|NCT03153904|"     Connecticut Child STEPS is a randomized controlled trail investigating the effectiveness of     MATCH-ADTC in treating anxiety, depression, trauma, and/or behavioral problems in children     seeking services at four Department of Children and Families (DCF) funded clinics in the     state of Connecticut. The study will evaluate child outcomes following two forms of therapist     training in the MATCH model.   "
10089|NCT03153891|"     This randomized controlled trial examines the effect of nature exposure on pain intensity     levels among older adults who experience chronic pain. Investigators examine the effects of     nature on: the experience of chronic pain, on pain catastrophizing, and on attention     restoration.   "
10090|NCT03153878|"     This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In     addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant     therapy in patients with unruptured intracranial aneurysms associated with ischemic heart     disease or ischemic cerebrovascular disease. The investigators aim to use research data to     create a China national database of UIA   "
10093|NCT03153839|"     Introduction: physical activity in infants through aquatic therapy is widely known for the     later development of sensory ,cognitive and motor areas. In this way, babies will have a     greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin     therapeutic safety in the water is very broad, which allows an optimal development of aquatic     early stimulation programs.      Objective: To determine the relationship between aquatic physical activity in infants and the     development of their psychomotor skills in their first year.      Methods: A prospective case-control study will take place for 12 months. Participating     infants will be divided in two groups: an experimental group, which will be integrated by 74     babies who will participate with their parents in the aquatic physical activity programme in     a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the     activities. The aquatic activity will consist on 20 minutes sessions twice a week.   "
10113|NCT03153579|"     Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans the 1950s     and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research     with LSD ended in the 1970s due to regulatory restrictions but its use for personal and     recreational purposes continued. In recent years, there has been a renewed interest in the     use hallucinogens in psychiatric research and practices. LSD and psilocybin were reused in     experimental studies in healthy subjects and in the treatment for anxiety in patients with     life-threatening diseases. Specifically, a pilot study documented that LSD can be used safely     and may reduce anxiety in these patients. Larger well-designed and placebo-controlled studies     are warranted. Similar studies have recently been completed with the hallucinogen psilocybin.      Objective: To test the efficacy of LSD in patients with anxiety with or without     life-threatening diseases.      Design: Double-blind, placebo-controlled random-order cross-over trial using two LSD (200 µg)     and two placebo sessions with subjects acting as their own control.      Participants: 40 patients aged > 25 years with anxiety disorder (according to DSM-IV or a     state-trait anxiety inventory score >40 in the STAI trait or state scale) with or without     life-threatening illness.      Main outcome measures: Reduction in anxiety (STAI), depression (Hamilton depression rating     scale, HDRS and Beck depression inventory, BDI), and general psychopathological symptoms     (Symptom Check List 90 items, SCL-90) at 2, 8, and 16 weeks after LSD- compared with     placebo-assisted psychotherapy.      Significance: Anxiety disorder (alone or in the context of life-threatening illness) is     frequent and often insufficiently managed with available medications. This study will     evaluate the potential benefits of single treatments with LSD in anxiety disorder.   "
10094|NCT03153826|"     Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway     obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations     contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of     strength and muscle mass) is one of comorbidities affecting 30% to 60% of patients and     playing a key role in their prognosis. Indeed, several studies have shown muscle weakness     during hospitalization for exacerbation of COPD by measure of maximal voluntary contraction     of quadriceps (MVCQ), but the results are variable from one patient to another. Moreover, no     study was interested in the change of muscle mass in patients hospitalized for an     exacerbation of COPD. Several mechanisms have been mentioned but not demonstrated: systemics     factors (initial amyotrophy, inflammation, oxidative stress, corticotherapy, hypoxia…) but     also physical inactivity. In this context, identifying factors associated with the onset of     muscle weakness during hospitalization for exacerbation of COPD is a necessary step to better     understand the mechanisms and consider a personalized therapeutic approach that can improve     the functional and clinical prognosis of disease.      The primary outcome is to identify the clinical and biological determinants associated with     the onset of amyotrophy (Measure by ultrasound of sectional area of the Rectus Femoris,     CSARF), during hospitalization for exacerbation of COPD. The secondary outcome is to identify     the clinical and biological determinants associated with the onset of MVCQ decrease, during     hospitalization for exacerbation of COPD.      120 patients hospitalized for exacerbation of COPD will be recruited in two hospitals (CHU     Montpellier - CHU Grenoble, FRANCE). The measures of CSARF and MVCQ are carried out on the     second, fifth, eighth day of hospitalization, on discharge and on the sixtieth day after     hospitalization. A blood test will be performed on the second day of hospitalization to     explore different markers of inflammation and oxydative stress. Moreover, to quantify the     level of physical activity (number of steps), each patient will carry a pedometer throughout     the duration of hospitalization.      At the end of protocol, two groups will be made from the median of CSARF : patients with a     small reduction in CSARF compared to patients with a greater reduction in SSRF between the     second and eighth days of hospitalization (or between the second day of hospitalization and     discharge). Then clinical (comorbidities, severity disease, initial weakness, initial     amyotrophy, usual physical activity before hospitalization, treatment, exacerbation number in     the previous year…) and biological (markers of inflammation and oxydative stress)     determinants were compared between the two groups.      Thus, the identification of the determinants associated with the onset of amyotrophy induced     during exacerbation of COPD will guide research for exploration of physiopathological     mechanisms of this muscular dysfunction in the exacerbation of COPD as well as to identify a     personalized support.   "
10095|NCT03153813|"     To assess the efficacy and safety of high concentration capsaicin patches in pain due to     osteoarthritis (OA) of the knee in patients with obesity   "
10096|NCT03153800|"     Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD),     bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary     structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli     to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed     phase I clinical trial by transplantation of autologous bronchial basal cells on patients     suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which     were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly     into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6     months, the safety and efficacy of the treatment will be monitored by measuring the key     clinical indicators.   "
10097|NCT03153787|"     The objective of the present study to analyze the vaginal microbiome in patients who have not     achieved gestation after oocyte donation treatment and after probiotic administration.      All patients will receive vaginal probiotic according to the standard regimen. Sample     collection will be performed the embryo transfer day and on the day of the pregnancy test.     Follow up of gestation will be carried out.      The analysis of the vaginal microbiome will be performed though massive genetic sequencing     (determination of 16SRNA).      The study variables, among others, are vaginal microbiome pattern after probiotic     administration, the gestation rate, and the abortion rate.   "
10098|NCT03153774|"     The main objective was to assess the prevalence of sarcopenia in chronic heart failure     patients and in patients before the trans aortic valvular implantation.      The loss of muscle mass in chronic heart failure patients is a prognostic factor for     sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better     management.   "
10099|NCT03153761|"     This study will evaluate exposure to tobacco constituents from two moist snuff products, and     provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of     each of the two moist snuff products.   "
10100|NCT03153748|"     This study aims at clarifying the current situation of Emergency treatment of aneurysmal     subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the     treatment strategy between interventional treatment and open surgery, so as to improve the     diagnosis and treatment of aneurysmal SAH.   "
10101|NCT03153735|"     The investigators aimed to confirm the efficacy and safety of transdermal penis enlargement     for 24 weeks after CMDHA0101 injection in subjects who wanted penile enlargement in male     patients with small-penis syndrome *.      *Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it     isn't.   "
10102|NCT03153722|"     This study will utilize an iterative quality improvement process to identify and address     delays in the pediatric hospital discharge process.   "
10103|NCT03153709|"     The purpose of this study is to compare the pregnancy rates among women who are using the HIV     drug Efavirenz and either the birth control injection or implant.   "
10104|NCT03153696|"     The purpose of this study is to assess the feasibility (fidelity, acceptability,     implementation, cost) of the Cellie Coping Kit for Children with Injury as well as to     determine the intervention's efficacy (mechanisms of action and health outcomes).   "
10126|NCT03153410|"     This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody     that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and IMC-CS4     (LY3022855) (an antibody that blocks a molecule called CSF1-R which prevents the bodies     ability to fight cancer) is effective (anti-tumor activity) and safe in patients with     borderline resectable pancreatic cancer.   "
10603|NCT03147274|"     SMART T1D is a research study that offers interactive diabetes education for teens with type     1 diabetes in peer groups led by diabetes nurse educators. Participants in the study will be     randomly assigned to either receive three of the group sessions in addition to their routine     clinic care or to receive their usual diabetes clinic care.   "
10114|NCT03153566|"     Cutaneous and genital warts are common dermatological conditions caused by Human Papilloma     Virus. Although it is a benign condition it causes disfigurement, has tendency to collect,     can be transmitted to others, this makes adequate and timely treatment important, while many     warts are resolve spontaneously over several years, most patients seek treatment because the     warts are unsightly and often tender or painful.   "
10269|NCT03151538|"     The study was planned to assess effects on pes planus and femoral anteversion angle of     exercise training mixed with play on pre-school children.   "
10270|NCT03151525|"     Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12     months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine     (AZA).      Each patient will be followed for 12 months.   "
10105|NCT03153683|"     This is a prospective open enrollment registry to evaluate arterial blood and thrombus     removed during the standard thrombectomy procedure, which will then be used for the purposes     of identifying biological markers, inflammatory cell infiltrates, and biological states in     large vessel occlusive stroke in the human condition. The primary objectives are to evaluate     the feasibility of obtaining distal clot blood during thrombectomy; develop a group of     biosamples (blood and clots) to evaluate novel proteins, cell types, and cytokines in acute     ischemic stroke in the human condition, and evaluate specific biomarkers, proteins, and     leukocyte populations in stroke in the human condition. The study population will include up     to 250 subjects. Male and female participants 18 years of age and older will be enrolled.     Participants must have had a suspected acute ischemic stroke based on clinical and     radiographic evidence as determined and documented by the Stroke Neurology team at University     of Kentucky. There is no therapeutic intervention involved in this study.      This is the first study to our knowledge that will utilize thrombectomy technique to collect     focal blood samples and the clot related brain infarction. This proposal will provide     preliminary data needed to understand relationships between the local inflammatory cascade     and clinical variables such as age, gender, time from symptoms to thrombectomy, and stroke     imaging results. Characterizing these relationships is vital in the formulation of related     therapeutics. Issues of gender-differences, age-based variations, and co-morbidities all     engender heterogeneity, which plague translation of stroke research from animal to human. By     starting with the human condition, the investigators aim to minimize this loss in     translation. Overall, this study will have a great impact on our knowledge of stroke     pathology. In essence, this could fundamentally change not only how the investigators develop     treatment strategies for the stroke patient population but allow us to individualize the     treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques     that are impractical when delivered systemically could be delivered locally to impede the     early inflammation.   "
10106|NCT03153670|"     Deep brain stimulation (DBS) is an established treatment for advanced Parkinson's disease,     medically refractory tremor, dystonia and obsessive compulsive disorder. Several hypotheses     driven DBS trials are underway to study modulation of circuit dysfunction in other     neurological and psychiatric disorders like epilepsy, Alzheimer's disease and depression.     Recent reports suggest profound effects of DBS on the anatomy and function of downstream     areas in the brain. For example electrical stimulation of limbic circuits is associated with     increase in hippocampal neurogenesis. Similarly, stimulation of subthalamic nucleus (STN) or     globus pallidus (GPi) results in activation of cortical motor circuits. Non-invasive imaging     modalities are increasingly being employed in these investigations to better understand the     effects of DBS on the structure and function of the brain.      There have been important advances in MRI and we now have MRI which provides higher     resolution and higher quality brain images. More specifically, the investigators propose to     use MRI to perform functional magnetic resonance imaging (i.e. fMRI) to assess the effects of     deep brain stimulation on brain function.   "
10107|NCT03153657|"     Objectives: This study aims to evaluate the effectiveness of preemptive administration of     non-steroidal anti-inflammatory Piroxicam-beta-Cyclodextrin on risk and level of tooth     sensitivity caused by in-office bleaching procedures using 35% hydrogen peroxide.      Fifty patients will be selected for this triple-blind, randomized, cross-over,     placebo-controlled clinical trial. Piroxicam-beta-Cyclodextrin (200 mg) or placebo will be     administrated in a single-dose thirty minutes prior to bleaching procedure. The whitening     treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day     interval. Tooth sensitivity will be assessed Immediately before bleaching agent removal and     up to 24 hours after each session the procedure using analog visual and verbal scales. Color     alteration will be assessed by a bleach guide scale 7 days after each session. Relative risk     to sensitivity will be calculated and adjusted by session; while comparison of overall risk     will performed by Fisher's exact test. Data on the sensitivity level for both scales and     color shade will be subjected to the Mann-Whitney and Friedman tests, respectively (α =     0.05).   "
10108|NCT03153644|"     The purpose of this project is to describe how contraceptive services are currently being     delivered to women with medical conditions who seek care in community-based primary care     settings, such as family medicine and internal medicine clinical offices.   "
10109|NCT03153631|"     Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death     among females world wide. breast cancer alone accounts for 25% of all cancer cases and 15% of     all cancer deaths among females.   "
10110|NCT03153618|"     The collection and analysis of family, medical, lifestyle, and environmental exposure history     (a Comprehensive Health History or CHH) can identify critical risk factors for many chronic     and life-threatening conditions, including cancer. Despite its importance, CHH is     infrequently documented and analyzed in primary-care medical practice due to numerous     hurdles, and currently available tools have proven inadequate to address this critical     problem. This study will evaluate the Virtual Agent Linked Intelligent Disease Assessment     Tool Engine (VALIDATE) system as an easy to administer, accurate, cost-effective, and     clinically useful tool for collecting and analyzing structured CHH data.   "
10111|NCT03153605|"     Explore the correlation and specific relationship between chromaticity parameters and     treatment satisfaction before and after tooth bleaching, compare the curative effect of     different tooth bleaching programs.   "
10112|NCT03153592|"     Laparoscopy and robotic techniques are widespread procedures for pelvic gynecologic, urologic     and abdominal surgery often performed in Trendelenburg position, with the application of     pneumoperitoneum by inflating carbon dioxide. The rise in abdominal pressure following     pneumoperitoneum and the head down body position have been shown to impair the respiratory     function during the procedure, mainly inducing atelectasis formation in the dependent lung     regions, worsening stress and strain of the alveolar structure.      The application of a ventilator strategy providing positive end-expiratory pressure (PEEP)     has been shown to reduce the diaphragm cranial shift, increasing functional residual capacity     and decreasing respiratory system elastance. Furthermore, the application of recruiting     maneuver followed by the subsequent application of PEEP improved oxygenation. These results     are in accordance with finding by Talmor et al, evaluating the effect of a mechanical     ventilation guided by esophageal pressure in acute lung injury patients.      However a comparison between an esophageal pressure piloted mechanical ventilation and a     conventional low tidal ventilator strategy with adjunct of PEEP and recruitment maneuvers     according to clinical judgment has never been investigated in patients undergoing robotic     gynecologic, abdominal or urologic surgery. The investigators aim to compare the conventional     ventilation strategy (i.e., low tidal volumes, application of PEEP and recruitment manoeuvre)     with a ventilation driven by transpulmonary pressure assessed through an esophageal catheter,     in patients undergoing to robotic surgery, with respect to oxygenation, expressed in terms of     arterial oxygen tension - inspired oxygen fraction ratio (PaO2/FiO2) (primary endpoint),     intraoperative respiratory mechanics indexes, number of lung recruitment maneuvers, rate and     type of perioperative complications until hospital discharge (additional endpoint).   "
10127|NCT03153397|"     This study plans to learn more about the impact of enteral nutrition on bacteria in     critically ill trauma patients with brain injury. Specifically, it seeks to understand the     effect that a prebiotic containing enteral feeding formula (Nutraflora scFOS in Vital AF) has     on the gut, oral, and skin bacteria. A prebiotic is a special form of dietary fiber that acts     as a fertilizer for good bacteria. The prebiotic Nutraflora scFOS has been cleared by the     U.S. Food and Drug Administration and is not considered investigational as used in this     study. Enteral feeding is a way to give nutrition to critically ill people who are unable to     eat.   "
10115|NCT03153553|"     Regular physical activity improves aspects such as physical fitness, fatigue, quality of     life, gait and also reduces the rate of progression of disability in individuals with     Multiple Sclerosis. However, individuals with multiple sclerosis are less physically active     than the general population. The determinants of engaging in physical activity for     individuals with multiple sclerosis include psychological factors like motivation,     self-belief and self-regulatory constructs and physical factors like fatigue, weakness, pain     and ataxia.      Ischemic preconditioning is exposure of the body to brief periods of circulatory occlusion     and re-perfusion to protect organs against ischemic injury. Recent studies have also shown     that ischemic preconditioning also improves exercise performance in healthy participants.      The primary aim and objective of this study is to see whether it is feasible to use Ischemic     preconditioning to improve exercise performance in people with Multiple Sclerosis.      The design for the study is a double blind randomized control trial. Forty patients with     multiple sclerosis above 18 years of age and who have the ability to walk will be randomized     to receive either Ischemic preconditioning or sham intervention. All participants will be     identified by MS consultants and nurses from the MS clinic and Neuro Day Case Unit of the     Royal Hallamshire Hospital in Sheffield. Participation will involve an additional 2 hours of     the patients time.   "
10116|NCT03153540|"     Nonfluent/agrammatic variant primary progressive aphasia (nf/avPPA) is a fatal     neurodegenerative disease that begins with isolated language deficits. There is currently no     cure or treatment for this disease. Repetitive Transcranial Magnetic Stimulation (rTMS), a     noninvasive neuromodulatory technique, is effective in major depression, and studied in many     other conditions including nf/avPPA. Here the investigators propose to study the feasibility     and change in language and brain function of a newer rTMS protocol (intermittent theta-burst     stimulation, iTBS) using a randomized, blinded crossover design: participants will receive     active or sham iTBS for two weeks and then switch groups without them or clinicians knowing     their group. The investigators hypothesize that brain function and performance with language     tasks will change after active iTBS.   "
10117|NCT03153527|"     Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid     termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.   "
10118|NCT03153514|"     The primary objective of the study is to evaluate the feasibility, efficacy and safety of an     obinutuzumab containing conditioning regimen for poor risk CLL patients and patients with     Richter`s transformation requiring an allogeneic stem cell transplantation.   "
10119|NCT03153501|"     Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and     medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus     exists regarding which biopsy methods are appropriate for specific procedures.      In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy     using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle     (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.   "
10120|NCT03153488|"     This is a 6-month open-label, randomized control trial in adults to find out if certain     neuromarkers can predict individual treatment response to stimulant medications for Attention     Deficit Hyperactivity Disorder (ADHD). Males and females, ages 18-55, will be randomized to     receive either an amphetamine or a methylphenidate formulation for their ADHD. Before     beginning to receive medication treatment, each subject will complete an MRI scan at MIT.   "
10121|NCT03153475|"     Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE®     Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP)     tibial component with the posterior stabilizing (PS) femoral component in revision total knee     arthroplasty.   "
10123|NCT03153449|"     Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE®     Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP)     tibial component with the posterior stabilizing (PS) femoral component in complex primary     total knee arthroplasty.   "
10124|NCT03153436|"     The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation     of human sperm on the outcome of cryopreservation.   "
10125|NCT03153423|"     To evaluate preoperative risk factors for overcorrection and undercorrection following     surgery for basic intermittent exotropia such as axial length of the globe, refractive error,     age and sex   "
10128|NCT03153384|"     To evaluate the performance of a single high volume blood culture sampling strategy versus     the actually used multiple sampling strategy for the diagnosis and categorization of     infective endocarditis according to the Duke-Li classification in a Population of adults     suspected of infective endocarditis.   "
10129|NCT03153371|"     This study attempts to identify two types of AD by using clinical and cognitive tasks and     brain imaging. The subtypes of AD are separated into a typical group (memory loss) and a     variant group (language, visuospatial, and other cognitive difficulties). Performance on     the clinical tasks and brain imaging will be compared among the young-onset Alzheimer's     disease group, a late-onset Alzheimer's disease group, and a control group.   "
10130|NCT03153358|"     Many patients with oncogene-driven non-small-cell lung cancer (NSCLC) treated with tyrosine     kinase inhibitors experience limited sites of disease progression. For multiple metastases in     patients with advanced NSCLC, increased local treatment may benefit to prolong patient     survival. This study investigated the benefits of icotinib limited systemic disease     progression and continuation of Stereotactic Body Radiation Therapy,in patients with     metastatic EGFR-mutant NSCLC.   "
10185|NCT03152643|"     The success of assisted reproductive technology (ART) is to achieve healthy live births with     high utilization rate of embryos and low rate of adverse effects. Previous studies showed     that live birth rates slightly increased after single blastocyst-stage embryo transfer     compared with single cleavage-stage embryo transfer, however cumulative pregnancy rates     between the two groups decreased significantly. So far there is lack of data on cumulative     live birth rates. The aim of the present study is to compare cumulative live birth rates     after cleavage-stage and blastocyst-stage embryo transfer in IVF/ICSI treatment cycles.   "
11125|NCT03140280|"     This is a phase II, single-group pilot study to evaluate efficacy and pharmacokinetics. This     study's overarching aim is to evaluate the systemic effects of black raspberries in patients     with myelodysplastic syndrome. Twenty-one patients with MDS will be treated with 25 gm     (2x/day) of BRB powder taken orally.   "
10131|NCT03153345|"     Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary     function and stroke-related disabilities in stroke patients.      Design: Prospective randomized controlled trial      Setting: A single physical medicine and rehabilitation department at a university hospital      Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned     to either the intervention group or the control group.      Intervention: Both groups participated in a conventional stroke rehabilitation program.     During the study period, the intervention group received bedside respiratory muscle training     twice a day for three weeks. The respiratory muscle training consisted of (1) a breath     stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The     participants were evaluated at baseline and again at the end of the study (3 weeks later).      Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional     vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow.      Secondary outcomes were stroke-related disabilities assessed by the following: National     Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer     Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.   "
10132|NCT03153332|"     To our knowledge, it has not been analyze whether 3D printed liver model would improve the     perception of a given liver tumor or the precision of operation planning in liver surgery. We     design this prospective controlled trial to test whether the 3D-printed patient specific     liver model could be more informative than standard MDCT (multi-row detector computed     tomography ) and 3D visualization system in predicting the surgical anatomy of liver.   "
10133|NCT03153319|"     Randomized, double-blind, placebo-controlled, parallel-group, single-center study followed by     open-label phase, to evaluate the effects of adalimumab compared to placebo on the change     from baseline in joint and skeletal disease in children and adults with mucopolysaccharidosis     (MPS) I or II.   "
10134|NCT03153306|"     Correction of hypovolemia is an important therapeutic measure，Even though there is no     consensus regarding infusion rates, a plasma volume (PV) expander is often given at a fast     rate to treat a suspected hypovolemia without delay which can be associated with aggravation     of adverse interstitial accumulation of macromolecules and fluid, especially in inflammatory     conditions such as sepsis.the smallest possible volumes for PV resuscitation to maintain     normovolemia should be used to reduce the risk of simultaneous interstitial fluid     accumulation. The investigators tested the hypothesis that a slow infusion rate of a PV     expander results in better plasma expansion than a fast infusion rate to patients with severe     sepsis or septic shock.   "
10135|NCT03153293|"     This study is meant to evaluate the safety and efficacy of rAAV2-ND4 treatment for Leber     hereditary optic neuropathy with the G11778A mutation in mitochondrial DNA.   "
10136|NCT03153280|"     This study is a phase Ib, open label, multi-centre trial designed to estimate the Maximum     Tolerated Dose (MTD) of lithium when combined with a standard chemotherapy regimen of     oxaliplatin and capecitabine in patients with advanced, unresectable, oesophago-gastric or     colorectal cancer who have received no previous treatment for advanced disease (previous     adjuvant or neo-adjuvant treatment is acceptable if completed at least 6 months prior to     registration).      The study follows a modified Fibonacci, 3+3, dose escalation design. Patients are enrolled in     cohorts of 3. All three patients in each cohort must complete at least two cycles of     treatment to be evaluable for toxicity. If a patient cannot complete 2 cycles, another     patient will be enrolled.   "
10137|NCT03153267|"     The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline     treatment in patients with erythema migrans.   "
10138|NCT03153254|"     The purpose of this study is to investigate the usability of a new upper limb robot assisted     therapy device in stroke patients.   "
10139|NCT03153241|"     Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and     mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions     accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the     lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been     recommended as a preventive strategy to avoid microaspiration and VAP. In this context,     whereas considerable literature exists on the use subglottic secretion drainage (SSD) in     patients at risk for developing VAP, there is a lack of data on the bacterial growth in the     subglottic fluid above the cuff.      The primary objective of the study will be to assess the value of subglottic secretion     culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to     our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point     will be to estimate the predictive value of subglottic secretion culture in identifying     bacterial pathogens in the sub-population of patients who will develop VAP.   "
10140|NCT03153228|"     Electronical cigarettes, also known as e-cigarettes are a new phenomenon, which steadily     wins more aprobation among smokers. However, there exists no much data concerning the effects     of acute exposure to electronic cigarettes vapour on the respiratory system.      The aim of the present study is to evaluate and compare the acute response to electronic and     traditional cigarettes in healthy smokers.   "
10141|NCT03153215|"     Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and     severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer     a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.   "
25216|NCT02955615|"     The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human     recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus     erythematosus.   "
10199|NCT03152461|"     This study will evaluate the performance of the Quantra System comprised of the Quantra     Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical     procedures specifically, major cardiac and vascular procedures and major orthopedic surgery     (primarily complex spine surgeries).   "
10200|NCT03152448|"     This is a prospective study to measure the impact on first-line therapy of genomic testing of     biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized     prostate cancer.   "
10201|NCT03152435|"     This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and     feasibility of chimeric antigen receptor EGFR (EGFR CART) cells in metastatic patients with     colorectal cancer.   "
10142|NCT03153202|"     The purpose of this study is to determine the most appropriate dose for the combination of     ibrutinib and pembrolizumab and to see if the combination is active for the disease. The     study will monitor for any side effects and if the combination of ibrutinib and pembrolizumab     works in the cancers being studied.      There will be 2 experimental drugs given to the subject in this study. One experimental drug     used in this study is called ibrutinib and the second is called pembrolizumab.      This is the first time that ibrutinib will be used in combination with pembrolizumab. This     combination is considered experimental. Experimental means that it is still being tested to     see if it is safe and effective. Ibrutinib is a new drug known as a 'Bruton's Tyrosine Kinase     (BTK) inhibitor'. Ibrutinib blocks an enzyme (protein) that affects how certain types of     blood cancer cells grow and survive. Blocking this enzyme is a very important mechanism in     killing blood cancer cells. Ibrutinib has been approved in the United States, Israel, and the     European Union for use in adult patients with mantle cell lymphoma (MCL) and adult patients     with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.     Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will     allow the body's immune system to work against tumor cells. Pembrolizumab is approved for use     by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with     melanoma (skin cancer) who have received prior treatments. Pembrolizumab is not FDA approved     to treat patients with chronic lymphocytic leukemia [CLL] and mantle cell lymphoma [MCL].   "
10143|NCT03153189|"     To find out the relationship between physical activity and        -  self-esteem,        -  sleep quality,        -  anxiety & depression,        -  body fat percentage,        -  quality of life, in college females   "
10144|NCT03153176|"     Background: The health promotion actions carried out in the school environment have positive     effects on reducing risk factors for chronic diseases in adolescents. Interdisciplinary     strategies involving school and family to increase the level of physical activity among     adolescents, inside and outside the school, are essential to encourage healthier lifestyles.      Aim: To determine whether a 24-weeks interdisciplinary intervention program promotes     improvement in the level of physical activity, physical fitness, sleep quality, life     satisfaction, eating habits and reduce the sedentary behavior of schoolchildren aged 10 to 13     years of public schools in the city of Presidente Prudente, São Paulo, Brazil.      The intervention: Includes training of teacher Physical Education in the principles of     self-determination theory and ecological theory at practical applications for motivating     adolescents in physical activities and sports. The students will be given information on the     benefits of a physically active lifestyle and will be encouraged to participated the new     opportunities for physical activity in their school and community. The program will offer     physical activity strategies over the 24-weeks during class Physical Education, afternoon     recess and active lesson breaks in theoretical classes. Nutritional guidelines and gardening     experience will be developed to encourage healthy eating habits among schoolchildren and to     reduce salt, oil and sugar in the preparation of school lunch.      Methods/design: The project, which being conducted as cluster randomized trial, is to     evaluated whit in a mixed methods, including qualitative and quantitative approach will be     used for the construction of the actions integrated to the school physical education     curriculum and evaluation of the program by the participants and supporters. The RE-AIM     evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used     to guide the validation this program.   "
10145|NCT03153163|"     This is an open-label Phase I study of single-agent trastuzumab emtansine administered by     intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab     emtansine and its relevant analytes and the safety of trastuzumab emtansine in Chinese     participants with human epidermal growth factor receptor 2 (HER2)-positive locally     advanced/metastatic breast cancer (LA/MBC).   "
10146|NCT03153150|"     Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic     intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does     starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction     of all serious vascular events compared with not starting OAC?      Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel     group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies.     Investigators plan for a pilot phase, followed by a main phase.   "
10148|NCT03153124|"     Patients with chronic kidney disease in hemodialysis have complex syndrome with diverse     effects on cardiovascular, nervous, respiratory, musculoskeletal, immune and     endocrine-metabolic systems. With regard to the musculoskeletal structure, there is     progressive muscular loss with consequent increase in muscle weakness, limited resistance,     exercise intolerance and fatigue, as well as functional and morphological abnormalities     characteristic of uremic myopathy. Respiratory muscles are also affected as a result of     uremic myopathy, with decreased strength and resistance. Objective: to analyze the impact of     respiratory muscle training on muscle strength, functional capacity and quality of life of     patients with chronic kidney disease on hemodialysis. Method: This is a prospective,     randomized study involving 46 patients followed by the dialysis unit of a university     hospital, over 18 years old, of both genders who underwent hemodialysis for more than six     months and who signed the informed consent form. Patients will be allocated into two groups:     respiratory muscle training with PowerBreath and control. All will be evaluated for     demographic data, respiratory muscle strength, lung function, functional capacity and quality     of life. The intervention group will perform three months of intradialytic training of a     physical therapy protocol with PowerBreath. Both groups will be reevaluated after three     months.   "
10149|NCT03153111|"     This is a study to evaluate whether macitentan is an effective and safe treatment for     patients with heart failure with preserved ejection fraction and pulmonary vascular disease   "
10194|NCT03152526|"     This is a phase II trial designed to test the safety and efficacy (complete response [CR]) of     related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous     leukemia (AML).      Patients with newly diagnosed AML who failed to achieve a complete remission (CR) after one     or two standard induction attempts receive after a preparative regimen of cyclophosphamide     and fludarabine a single infusion of CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a     short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.   "
10195|NCT03152513|"     The objective of this study is to look at critical events in the pediatric operating room in     a retrospective and now prospective fashion to determine if there are any trends such as age,     presence of URI, type of surgery, type of airway, level of hands on provider, or other     predictive markers associated these events so that we may gain some insight into perhaps     reducing the incidence of these events or simply be more attune to the increased risks in     certain situations.   "
46747|NCT02673749|"     RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its     potential to improve the tolerance of lactose (dairy products).   "
10150|NCT03153098|"     There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer     from conditions such as diabetes, cardiovascular disease, and poor mental health. These     problems often co-exist more frequently in areas of higher socio-economic deprivation. There     is an ongoing need to test the effectiveness, acceptability, and sustainability of community     physical activity interventions. The Active Herts programme is a community physical activity     programme aimed at inactive adults aged 16 and over who have one or more risk factors for     cardiovascular disease (CVD) and/or a mild to moderate mental health condition. The programme     uses the latest evidence-based behaviour change techniques to target physical activity,     wellbeing, and key drivers of behaviour from the COM-B ('Capability', 'Opportunity',     'Motivation' and 'Behaviour') model of behaviour change.      This evaluation will follow a mixed-methods longitudinal (baseline, and 3, 6 and 12 month     follow-ups) pragmatic observational design. Two types of programme are being delivered, each     in a different area. In one, group participants will receive a behaviour change technique     booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call     (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of     exercise classes. In the other 'enhanced delivery' group, participants will receive the same     but the 12 weeks of exercise will be free and tailored to their needs, and there will be     optional exercise 'buddies' available. An outcome evaluation will assess changes in physical     activity as the primary outcome, and sporting participation, sitting, wellbeing,     psychological capability, and reflective motivation as secondary outcomes. A process     evaluation will use both one-to-one interviews and focus groups to explore the views of     stakeholders, delivery staff, and participants over three phases (set-up, deviations in the     delivery of the intervention, and looking back over the intervention). Economic evaluation     will examine the costs of the Active Herts programme against the benefits gained in terms of     reduced risk of morbidity from a range of chronic conditions.      This study will measure key drivers of physical activity using up to date behaviour change     theory, allowing evaluation of not only whether physical activity has increased but also why.     The research will inform the future development of a scalable intervention that can be more     robustly tested in a randomised controlled trial.   "
10151|NCT03153085|"     The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is     effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic     melanoma.   "
10152|NCT03153072|"     The supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics.     Amiodarone is an antiarrhythmic drug used in this indication. Pharmacokinetic, efficacy and     safety data are not known in the pediatric population due to the lack of a suitable specialty     available on the market.      The development of an amiodarone oral solution formulation adapted to this age group should     provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy,     acceptability and tolerability of the drug.   "
10153|NCT03153059|"     We hypothesized that some difference in the composition and distribution of gut microbiota in     people with a large number of defecation (two or three times a day or more), people with     normal defecation (one time a day or two days), and people with a small number of defecation     (two times a week or less).      And we investigate the association between gut microbiota and stool frequency.   "
10154|NCT03153046|"     The investigators propose a maltodextrin-controlled cross over experimental medicine study     that aims to examine the role of the immune system in cognitive processes and weight gain in     40 adult patients with psychosis, stable on antipsychotic medication for over 1 month. There     is evidence suggesting the immune system is linked to brain function and weight gain, both     parameters that has been implicated in psychosis and antipsychotic use, and may underlie some     schizophrenic features. The fermentation of galacto-oligosaccharides (GOS), which are short     chain carbohydrates composed mostly of galactose sugar molecules, by the intestinal     microbiota has been shown to modulate the immune system and reduce the inflammatory response     in both animals and humans. Since the intestinal ecosystem is highly sensitive to dietary     changes, the growth of beneficial gut bacteria can be enhanced using a natural food     supplement similar to GOS known as prebiotics. The study will be controlled by taking     maltodextrin as a control supplement. Both prebiotics and maltodextrin are short chain sugar     compounds. The study will involve asking patients to take dietary supplement for a total of     24 weeks; GOS for 12 weeks and maltodextrin for 12 weeks as a control. Participants will be     randomised into groups, with half receiving maltodextrin followed by GOS, and half receiving     GOS followed by maltodextrin. Participants will be assessed on cognitive function and weight     gain at 3 specified time points.   "
10155|NCT03153033|"     What are the implications of wheelchair propulsion-induced fatigue for the development of     shoulder pain and how can this knowledge improve prevention programs?      With this project, the Shoulder Health and Mobility group of the Swiss Paraplegic Research     in Nottwil (Switzerland) wants to investigate how fatigue during wheelchair propulsion     affects risk factors for shoulder pain of persons with a spinal cord injury (SCI). The     investigators want to find out how the handrim wheelchair propulsion technique changes with     fatigue and want to define persons who are susceptible to fatigue.      Getting life back after a SCI will most likely occur with the help of a wheelchair, whether     it is at the beginning of rehabilitation or throughout further life. Gaining back mobility     and participation in social life is important, also because of the multiple positive effects     of physical activity on person's health and self-esteem, preventing several chronic diseases.     Therefore, it is needed to try to stay away from shoulder injuries. Since the shoulder is     very mobile and thus unstable, the joint is at increased risk for injuries. This is reflected     in the high amount of persons with a SCI having shoulder pain (between 30 to 70 %). Once pain     or an injury occurred, it is hard to recover, as so far no effective treatment is available.     Several factors as gender, weight, age, level and completeness of the SCI, movement patterns     and muscle strength were found to be related with injury and pain. However, it is currently     not well understood what exactly causes shoulder injuries.      Handrim wheelchair propulsion is an inefficient mode of propulsion and asks a lot of demands     to the upper body. Because of the inefficient movement and the shoulder being prone to     injuries, wheelchair propulsion has a high chance of inducing shoulder injuries and pain.     Propelling with a technique minimizing the loads on the shoulders and improving the capacity     to perform these movements (as increasing muscle strength) is of utmost importance as these     factors can be modified by training. Previous intervention programs have learned wheelchair     users to propel with long and smooth strokes aiming to reduce the loads. Although someone     might be aware of the recommended techniques and can apply them, propulsion technique might     change with fatigue and could become less optimal. A similar phenomena happens for example in     landing strategies from a jump. In a fresh state, persons will try to have a stable landing     reducing the impact on the lower limbs. With fatigue, however, there will be a tendency to     forget about the proper landing technique which on its turn can increase the risk of     injuries. This was suggested to be one of the reasons why there is an increased prevalence of     injuries towards the end of a game. So far, it is unclear how fatigue alters propulsion     technique and how these changes are related with an increased risk of shoulder pain.      Tis project aims to achieve the goals by investigating how very strenuous wheelchair     propulsion (fatigue intervention) of 15 minutes alters the propulsion technique of 50 persons     with a SCI. All participants will perform the fatigue protocol in the movement analysis lab     at the Swiss Paraplegic Research. During the protocol, participants will be requested to     perform as many 8 loops as possible with their wheelchairs, including starts, stops, and     right and left turns. Before and after the protocol, movement patterns, muscle usage and     loads during wheelchair propulsion and the characteristics of the shoulder muscle tendons     during rest will be assessed. Furthermore, the person's characteristics, such as weight, age,     gender, time since injury, injury level, health conditions, use of medication, muscle     strength and activity levels will be assessed. All these factors might be associated with the     susceptibility to fatigue.      To answer our questions, we will first compare the propulsion technique (movement patterns,     loads, and muscle usage) before and after the protocol to investigate the direct effect of     fatigue. Secondly, we will investigate the association of negative changes in tendon     appearance (which has been related to injury) with the changes in the propulsion technique to     investigate the implications of acute changes that might increase the risk of injury. Finally     we will run a model including all variables to determine which person's characteristics are     associated with an increased susceptibility to fatigue.      The results will be highly relevant as it will give answers about the content, the aims and     the target population of prevention programs for shoulder injury, aiming to improve mobility,     participation, and quality of life in persons with SCI.   "
10156|NCT03153020|"     The effectiveness of emergency management of acute ischemic stroke has improved considerably     in recent years with thrombolysis and more recently thrombectomy. This improvement is     accompanied by an increase in the number of stroke survivors. One of the major issues for     these ever-increasing survivors is the prevention of recurrence. According to data from the 3     French registries, more than 20% of patients have at least one recurrence. Secondary     prevention treatment has demonstrated his efficacy to prevent stroke recurrence.      This evolution justifies identifying factors associated with adherence to secondary     prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in     patients included in the STROKE 69 cohort.   "
10157|NCT03153007|"     Foot ulceration is a common and costly complication of diabetes. GSK1278863 is a topical     drug, which is being developed to treat wounds associated with DFU. The aim of this study is     to explore the symptoms and impacts of DFU from the subject perspective and to elicit     in-depth information about DFU signs and symptoms, impacts on functioning and health-related     quality of life (HRQoL). Adult DFU subjects with current or recent (within last six months)     neuropathic foot ulcers will be eligible to participate in this prospective, cross-sectional     interview study. Approximately 20 DFU subjects will be recruited from up to three clinical     sites. Potential subjects will be pre-screened and then contacted to gauge interest in the     study. Interested subjects will be screened and eligible subjects will consent to release     contact information to research staff. Research staff will contact the subject to schedule     interviews. This study will include concept elicitation interviews over the telephone or     in-person by trained and experienced interviewers. In-person interviews will be conducted in     a private room at the clinical site. All interviews will be conducted in English and will be     guided by semi-structured interview guides. All subjects will provide written consent prior     to the start of the interview.   "
10196|NCT03152500|"     In this study the investigators will investigate the stability of lens position and the     visual outcome after implantation of the new FEMTIS-IOL using FLACS capsulotomy compared to     conventional placement of the IOL in the capsular bag. So far, there are no published studies     using the FEMTIS-IOL. Therefore, the investigators will perform this randomized control     trial.   "
10604|NCT03147261|"     Central obesity, present in the metabolic syndrome (MS), is associated with increased risk of     insulin resistance (RI). The aim of the project is to evaluate the protective effect of     comprehensive intervention (Mediterranean diet + physical activity) in the development of RI     in children with central obesity based on genetic and epigenetic markers.   "
10158|NCT03152994|"     Chronic obstructive pulmonary disease(COPD), characterized by persistent airflow limitation,     associated with an progressive chronic inflammatory response of the lung to noxious particles     or gases, can lead to dyspnea and limited mobility and influence the life quality of patients     severely. Type 2 diabetes mellitus(T2DM), as a common complication of COPD, has got more     attention in comprehensive control of COPD. Stress response and metabolic disorder are more     likely to happen in COPD patients with T2DM in high level inflammation status, which decrease     the drug efficacy, increase the risk of acute exacerbation of COPD, complications and     mortality.      Both COPD and T2DM are chronic inflammatory disease with long term, there is close     relationship in occurrence and development of each other, and the patients with severe COPD     are more likely to develop T2DM. Monitoring the acute inflammation maker of C reactive     protein (CRP) and IL-6(interleukin-6) is the most useable way to predict the inflammatory     status and condition of COPD patient with T2DM, however the chronic inflammation maker is     lacking. Neutrophil-to-Lymphocyte ratio(NLR), platelet-lymphocyte ratio (PLR) and     lymphocyte-monocyte ratio (LMR) , the new, cheap and easy-tested chronic inflammatory     markers, have got great research in early predicting the tumor such as nasopharyngeal     carcinoma, soft tissue sarcoma and small-cell lung cancer,among them, NLR has manifest     promising application in predicting insulin-resistance. However the value about NLR,PLR and     LMR to predict the T2DM in COPD patients remain unknown and many articles related to NLR and     COPD are retrospective.      The investigators attempt to analyze the risk factors and predict value of NLR,PLR and LMR     about developing T2DM in COPD patients with prospective method.   "
10159|NCT03152981|"     In the present study, The investigators evaluated whether anesthetic agents effects on Optic     Nerve Sheath Diameter in patients undergoing Robot Assisted Laparoscopic Radical     Prostatectomy   "
10160|NCT03152968|"     Fundamental movement skill is the precursor for physical activity in later life. Proficiency     of Fundamental Movement Skills in Indian School Children is unknown. This observational trial     shall tell us how proficient are our Udupi District Children.   "
10161|NCT03152955|"     Perioperative pain is caused by a variety of harmful factors through multiple mechanisms,     therefore, reasonable postoperative analgesia should be combined with drugs or measures of     different mechanism , which is called multimodal analgesia. Multimodal analgesia could     minimize side effects and achieve a better analgesic effect. Commonly used strategies of     multimodal analgesia are oral analgesic drug, nerve block, patient controlled analgesia and     so on. This study will observe the effect of multimodal analgesia on postoperative pain in     patients with microvascular decompression and record side effects. Finally, it will provide     technical support for the guidance of postoperative analgesia in patients of trigeminal     neuralgia.   "
10162|NCT03152942|"     The aim of this study is to investigate whether the combination of aminophylline and     Progesterone (P4) is acceptable to women at high-risk of Pre-term labour (PTL). If this     proves to be the case, a larger double blind, randomised controlled trial will be conducted     to test the hypothesis that the combination of P4 and aminophylline reduces the risk of PTL     more effectively than P4 alone.      The study is a randomised study where participants will be either administered a combination     of aminophylline and Progesterone (P4) or Progesterone (P4) alone.As the study is open label,     the participants and the study doctor will know which study medications the participant is     taking at all times during the study.   "
10163|NCT03152929|"     The purpose of this study is to compare two standard methods of pain control management used     at Spectrum Health for patients undergoing breast surgery. The two methods being compared are     the paravertebral block and the pectoral nerve block. Postoperative pain control is essential     following any major operative procedure. A variety of methods have been utilized to ensure     adequate analgesia, each with its own advantages and risks. Increasingly, attention has     focused on regional methods of analgesia, which may allow for reduction in systemic narcotic     use and their associated complications. Proposed benefits of regional analgesia and a     resultant reduction in narcotic use include decreased risk of cancer progression, decreased     length of stay, and decreased risk of ileus.   "
10164|NCT03152916|"     This study aims to use 3D printing personalized plate to locate the position in which the     K-wires would be drilled to save operation time and decrease the number of times that the     K-wires are drilled.   "
10165|NCT03152903|"     This is a Phase II/III trial with two groups of adults successfully cured of category 1     pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be     administered to calculate efficacy of the vaccine against TB recurrence.   "
10166|NCT03152890|"     Glycemic control during liver transplantation is challenging especially after reperfusion of     the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively     analyzed using historical data. The proposed dose then is prospectively applied to the     patients to assess the adequacy of the insulin dose.   "
10167|NCT03152877|"     We propose a prospective, randomized, single blinded trial with subjects recruited from the     WRNMMC Labor and Delivery Unit to study post-partum efficacy of Exparel® for pain control in     patients undergoing a vaginal delivery who sustained a second, third, or fourth degree     obstetrical laceration. Subjects who meet inclusion criteria and agree to participate in the     study will be consented upon admission for active labor or induction of labor and will be     randomized to receive either 20mL of liposomal bupivacaine or 20ml of 0.25% plain     bupivacaine, infiltrated through the perineum at completion of their obstetrical repair.     Current standard of care is to receive no injection of local anesthetic upon completion of     the repair.      The primary aim of the trial will be to evaluate post-partum pain using a visual analogue     pain scale at days 1, 3 and 7 postpartum. All subjects will have acetaminophen, a     non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control     regardless of assignment, which is the usual post-partum pain control regimen.      We anticipate a 30% difference in post-operative pain measurements between the Exparel® group     and the plain bupivacaine group. Other aims of this study are to evaluate total medication     usage, comparing the study group to the control, and compare quality of life measures between     the two study groups.   "
10605|NCT03147248|"     This is a Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between CT-P13     SC and CT-P13 IV in Patients with Active Rheumatoid Arthritis.   "
25515|NCT02951702|"     The purpose of this study is to determine if oral vancomycin used as primary Clostridium     difficile prophylaxis can reduce the incidence of this infection in high-risk patients.   "
10168|NCT03152864|"     In order to assess the efficacy of the Rhythm Stabilization component of HealthRhythms'     product, investigators will recruit 128 outpatients between the ages of 18 and 65, presenting     to the University of Utah Department of Psychiatry outpatient clinics with a current mood     and/or anxiety disorder. Sixty-four of these individuals will be randomly allocated to     receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm     Stabilization) on their smartphones, while 64 will be asked to consent to Rhythm Sensing     only. Participants in both arms will receive treatment as usual (TAU) for their mood and/or     anxiety disorders, as typically provided at the University of Utah clinics. The duration of     the study will be 16 weeks.      The primary outcome measures of the RCT will be the PROMIS Depression, the PROMIS Anxiety and     the PROMIS Sleep Disturbance computerized adaptive testing (CAT) measures. The investigators     hypothesize that those receiving the full package will demonstrate lower levels of     depression, anxiety and sleep disturbance. In addition, investigators will explore the     relationship between sensed rhythm stability and scores on patient-reported outcome measures     of mood, anxiety and sleep disturbance (PROMIS). The investigators hypothesize that positive     changes in the PROMIS measures will be mediated by positive changes in rhythm stability.      The primary outcome analyses will be based on random regression models, while the mediation     analyses will follow the approach described by Helena Kraemer and colleagues.   "
10169|NCT03152851|"     Aim: to shorten the time of urination by bladder pressure stimulation in children less than     36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to     speed up the start time of antibiotics treatment or to eliminate the overcrowding of     emergency room(ER) by shortening the time of ER stay.   "
10170|NCT03152838|"     Autism Spectrum Disorder is a neurodevelopmental disorder characterized by impaired social     communication and repetitive or stereotyped behaviors. According to the World Health     Organization , the prevalence of Autism Spectrum Disorder is one person in 160.   "
10171|NCT03152825|"     A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting     at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%.     Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but     do not protect from myocardial ischaemia. In fact, percutaneous revascularization (PCI) of     CTO lesions leads to improved symptoms, functional class, quality of life, higher left     ventricular ejection fraction and improved survival in several observational studies.     However, due to the higher rate of procedural complications and lower success rate of PCI     than in other settings, it is attempted in only 10% of all CTO lesions. Myocardial     viability/ischaemia assessment should be performed before PCI to avoid potential PCI-related     complications and identify patients who might benefit most from myocardial revascularization,     individualizing the risk-to-benefit ratio. In this regard, patients with stable coronary     artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death     or MI of ~5%/year) and plausibly represent the best target for PCI.      Cardiac MRI (CMR) provide a reliable assessment of both myocardial ischaemia and viability.     Using late gadolinium enhancement (LGE) sequences, myocardial segments with LGE >75% of     transmurality do not show any improvement in contractility even after revascularization,     representing a subset of patients in which CTO PCI may be futile. Viability assessment by CMR     may be also performed with low dose dobutamine infusion; in patients with CTO and akinetic     segments, contractility improvement at low dose dobutamine may predict functional recovery in     the follow-up. Myocardial ischaemia may be assessed by CMR with high accuracy, identifying     perfusion defects during pharmacological-induced hyperemia and/or regional wall motion     abnormalities during inotrope infusion.      This study is designed to verify the hypothesis that myocardial ischaemia and viability     assessed by CMR could identify patients who are more likely to benefit from PCI in terms of     improvement in left ventricular remodeling, functional recovery and clinical outcome.   "
10172|NCT03152812|"     the investigators are trying to detect what is the best tissue constituent suitable for     reconstruction of large post traumatic sof tissue defects of foot plantar surface   "
10173|NCT03152799|"     Ischaemic stroke causes significant morbidity and mortality and is a leading cause of     disability within an ageing United Kingdom (UK) population. Proximal anterior circulation     occlusion is associated with a particularly poor prognosis, but its management has undergone     a paradigm shift following clinical introduction of endovascular recanalization, establishing     rapid reperfusion of the ischaemic penumbra.      Remote ischaemic conditioning (RIC) is highly effective at attenuating cerebral infarction in     basic research studies and has the potential to further improve patient outcome if used as an     adjunct to invasive revascularisation strategies. We aim to trial remote ischaemic     conditioning at the time of revascularisation, and then daily for the duration of the     seven-day in-patient stay, compared to a sham conditioning procedure. This pilot,     single-centre study will determine efficacy/ tolerability of RIC to reduce cerebral     infarction (primary endpoint: determined by brain magnetic resonance imaging [MRI]) and     improve functional status (secondary end-points: National Institutes of Health Stroke     Severity (NIHSS); European Quality of Life questionnaire EurQoL), with the data providing the     necessary parameters for power calculations and leveraging charitable funding for a     subsequent multi-centre study.   "
10174|NCT03152786|"     This randomized pilot clinical trial studies how well propranolol hydrochloride works in     treating patients with prostate cancer who are undergoing surgery. When stressed, the body     makes a molecule that may prevent tumor cells from dying, and propranolol hydrochloride may     affect the signals in cells that cause tumor cells survival and death.   "
10175|NCT03152773|"     Background:      Right heart catheterization tests heart pressures and flows. Magnetic resonance imaging (MRI)     fluoroscopy shows pictures of the heart that doctors can watch while they work. Researchers     want to test this procedure with a tool called a guidewire. This will help position the heart     catheter into different heart chambers. Guidewires are usually considered unsafe during MRI     because MRI can make them hot inside the body. Researchers have created special MRI settings     that stop one guidewire from getting hot. Using this guidewire during MRI may make improve     catheterization.      Objectives:      To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.      Eligibility:      Adults 18 and older whose doctors have recommended right heart catheterization.      Design:      Researchers will screen participants by reviewing their lab results and questionnaire     answers.      Participants will give 4 blood samples.      Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or     neck if they don t already have one.      Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be     placed against the body.      Participants will lie flat on a table that slides in and out of the MRI scanner as it makes     pictures. Participants will get earplugs for the loud knocking noise. They can talk on an     intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any     time.      For right heart catheterization, catheters will be inserted through the tubes already in     place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and     vessels. The guidewire will help position the catheter.   "
10177|NCT03152747|"     Phacoemulsification with implantation of posterior chamber lenses represents the gold     standard of care for patients needing lens surgery, but there is an increased risk of     developing pseudophakic retinal detachment after surgery. Especially myopic patients have an     even higher risk of pseudophakic retinal detachment compared to the general population.      The aim of this multicenter study is to document the presence and/or post-operative     development of posterior vitreous detachment (PVD) and to assess its influence on the     incidence of retinal detachment (RD) in myopes in a time period of three and five years after     lens surgery.      618 eyes of patients scheduled for regular lens surgery will be included, defined by an axial     length of 25.0 mm or more. To examine the vitreous status, all patients will receive a     comprehensive eye examination pre-operatively, including funduscopy with assessment of a     Weiss ring and optical coherence tomography (OCT). Patients will be divided into two groups,     group A with pre-operative complete PVD and group B with no/partial PVD. Group A will be     invited for one follow-up visit (two months post-operatively) followed up by telephone     interviews at one, two, three and five years after surgery to determine occurrence of     pseudophakic retinal detachment. Group B will be invited for follow -up examinations at two     months, six months and one year after surgery to document occurrence of PVD (if a PVD is     present at one of the follow-ups, no more visits are necessary). Two, three and five years     after surgery, all patients from group B will be interviewed by telephone, as in group A, to     document the occurrence of pseudophakic retinal detachment.      In the recent literature the association between the occurrence of PVD pre-/post-operative     and RD after lens surgery is well documented but not described for myopic patients. The     results of this multicenter study should help to tackle the problem of RD prediction in     myopic patients depending on their pre-operative vitreous status, especially in the setting     of refractive lens exchange.   "
10178|NCT03152734|"     The POSE study will predict critical stages and outcome in a large sample of all surgical and     non-surgical interventional patients ≥80 years of age in Europe.   "
10179|NCT03152721|"     With time most people with Parkinson's disease (PwP) develop fluctuations in motor symptoms     in relation to medication intake. The prevalence may be both under and overestimated as it is     based on history rather than observation. Patterns in fluctuations are difficult to determine     and it has been demonstrated that every 30-minute diaries need to be kept for 10 days or more     to safely represent fluctuation patterns. The Parkinson Kinetigraph (PKG) is an automated     system that is carried passively and provides similar information after wearing the device     for 6 days. Clinical experience is that most patients agree that results are representative     to their experiences. It is not known if using the PKG routinely at any stage of PD will     change management of the disease. The hypothesis of this study is that providing PKG     information to neurologists will lead to a more active management that may improve outcome in     PD patients.   "
10180|NCT03152708|"     This study was conducted on the post-operative tumor tissues from 62 GBM patients. 20 slices     are necessary for all the CD95 and CpG2 test in the central lab by the methods of     immunisation and DNA methylation.   "
10181|NCT03152695|"     High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can     be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the     ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill     tumor cells by the thermal effects, mechanical effects and acupuncture effects of the     high-intensity ultrasound.   "
10182|NCT03152682|"     A crossover design to evaluate the safety and efficacy of GoodIdea TM (trademark) on glucose     homeostasis in a healthy population. Eligible participants will be given either the GoodIdea     drink or placebo and a standardized meal and will consume both in approximately 15 minutes.     Blood will be drawn at several time points over a 3 hour period to determine the study     objectives. After a 7-day washout, the participants will come back to the clinic and and     complete the visit consuming the opposite product given at the previous visit. The primary     objective is to see the difference of the two-hour iAUC for intravenous blood glucose between     the active product (GoodIdea) and the placebo following a standardized meal.   "
10183|NCT03152669|"     The Salford Lung Study (SLS) subjects represent a group of COPD and asthma patients whose     disease is extremely well-characterised over a short time period. Subjects in the SLS     originally consented for information relevant to the study to be shared with the sponsor     (GSK). These data were limited to three years prior to randomisation and the twelve-month     interventional treatment period. Broadened access to patients' data would allow SLS subjects'     entire disease journey to be researched, presenting a rare opportunity to improve scientific     and clinical understanding of COPD/asthma disease risk, treatment and progression. This     proposal seeks to collect additional subject-level data from SLS patients via their     electronic medical records (encompassing past and future data for up to 10 years from the     date of consent) and via a one-off patient questionnaire administered at the time of consent.   "
10209|NCT03152331|"     The purpose of this study is to evaluate a model of mindfulness and neurofeedback among     physicians and nurses. Several hypotheses will be tested: 1) BIS values will decrease as the     number of sessions increase, 2) wellbeing scores will increase as the number of learning     sessions increase, 3) wellbeing scores will be associated with BIS values, and 4) different     attentional states will have more or less influence on reducing the BIS value.   "
10210|NCT03152318|"     This research study is evaluating an investigational drug called rQNestin34.5v.2. This     research study is a Phase I clinical trial, which tests the safety of an investigational drug     and also tries to define the appropriate dose of the investigational drug as a possible     treatment for this diagnosis of recurrent or progressive brain tumor.   "
10184|NCT03152656|"     Familial hypercholesterolemia (FH) is an inherited disorder of lipoprotein metabolism,     transmitted in an autosomal dominant manner and clinically characterized by elevated levels     of total cholesterol (TC) and low-density lipoprotein (LDL) cholesterol, the presence of     tendon xanthomas, and premature atherosclerosis.      The homozygous form of familial hypercholesterolemia (HoFH) with autosomal dominant     transmission, in which case both alleles of either LDLR, APOB, or PCSK9 gene are defective,     is a rare genetic disorder with prevalence estimated to be one per million population.      Large scale genetic screening for active FH cases finding has been performed in the     Netherlands, Spain, Norway and Wales. However, the FH population and prevalence in Taiwan     have never been formally studied. Patients are usually not under appropriate treatment owing     to lack of standardized diagnostic tool and treatment strategy for FH. Moreover, with the     emerging of new classes of LLTs, including microsomal triglyceride transfer protein (MTP)     inhibitor, antisense oligonucleotide inhibitor, and PCSK9 inhibitors, even homozygous FH     patients now have better chance to be treated to reach recommended treatment goals.     Therefore, A National FH registry is needed to collect contemporary data on diagnosis,     treatment and outcomes with long- term goals of improving diagnosis, management, and     reduction of unnecessary cardiovascular events in FH population in Taiwan.   "
10202|NCT03152422|"     uPROPHET aims to validate urinary proteomics for risk stratification and monitoring graft     performance is recipients of heart transplants   "
10186|NCT03152630|"     Around 10% of stroke survivors develop dementia within 3 months after stroke and over 20%     more stroke patients have dementia in the subsequent 3 years. Previous studies documented a     close relationship between stroke and Alzheimer's disease (AD). There are, however, no     reliable biomarkers to detect cognitive dysfunction and dementia among stroke patients or to     predict the risks of vascular dementia (VD) and AD among patients with stroke. There is a     clear need to identify novel mediators of cognitive dysfunction in stroke patients to provide     insights into the pathogenesis, to tailor clinical care based on risks, and to develop new     therapeutic strategies.      While the expression of messenger RNAs (mRNAs) and microRNAs (miRNAs) account for only ~1% of     all transcribed species, up to 90% of the mammalian genome is transcribed as long non-coding     RNAs (lncRNAs), a heterogeneous group of non-coding transcripts longer than 200 nucleotides.     LncRNAs have been shown to be functional and involved in specific physiological and     pathological processes through epigenetic, transcriptional and post-transcriptional     mechanisms. While the roles of lncRNAs in human diseases including cancer and     neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation     contributes to cognitive dysfunction and dementia in stroke patients.      In this proposal, we seek to apply next-generation sequencing technology to investigate     circulating lncRNA expression, as well as exosomal RNAs in the subjects with and without     cognitive dysfunction or dementia. In addition, we will apply the near-infrared spectroscopy     (NIRS) to evaluate cerebral blood flow, metabolism and oxygenation in these subjects. We will     test the hypothesis that circulating lncRNA/exosomal RNA signature and NIRS imagaing can     reflect the cognitive states in stroke patients. The accuracy, sensitivity and specificity of     the lncRNA-exosomal RNA-NIRS-based cognitive dysfunction scoring system will then be tested     in an independent, large validation cohort. Next, we propose to test the hypothesis that     circulating lncRNAs/exosomal RNA and NIRS imaging can be novel prognostic biomarkers to     predict cognitive dysfunction and dementia in stroke patients. These studies will also     establish a set of novel, lncRNA-based diagnostic and prognostic biomarker in stroke patients     to improve clinical preventive and therapeutic care.   "
10187|NCT03152617|"     Weight-reducing obesity surgery (OS) generally gives good results but complications are     common; e.g. impaired weight loss, weight regain, bowel pain, diarrhea, vitamin/mineral     deficiency, osteoporosis and impaired dental health. The BASUN study is a prospective 10-year     comparison of 1000 surgically and 400 conventionally treated individuals regarding adverse     side-effects, risk factors for complications and poor outcome.   "
10188|NCT03152604|"     Persistent pain (PP) affects many people worldwide. Patient Education is central to good     management. Pain neurophysiology education (PNE) is a new form of education. It aims to help     patients 'reconceptualise' their understanding of pain away from the perception that PP is an     indicator of tissue damage, to PP is due to a sensitised nervous system. This perception is     considered a less threatening and more conducive to rehabilitation. There is a growing body     of evidence supporting its effectiveness. One unpublished Australian study combined PNE with     a pain management program and found significant beneficial effects. However, there is a need     to test this intervention rigorously under randomised controlled trial conditions to inform     clinical practice. The Medical Research Council state that during the development and     evaluation of a complex intervention (in this case a PNE informed PMP), it is important to     undertake feasibility work, to investigate the components of randomised controlled trial     (RCT) methodology prior to a full scale trial. The overarching aim of this mixed-methods     study is to develop a feasible research protocol for a RCT investigating the efficacy of a     pain neurophysiology education informed pain management programme. In this feasibility study,     participants with PP will be assessed before and after a PNE informed pain management program     that they are due to receive as part of their usual care. In the week before the programme     participants will attend Teesside University (TU) where they will complete a battery of     outcome measures. A subsample of participants will also undergo a semi-structured interview.     In the week following completion of their usual care PMP participants will once again attend     TU where they will complete the same outcome measures and the same subsample of participants     will undergo a second semi-structured interview. At this point participants will have     completed the study.   "
10189|NCT03152591|"     The purpose of the study is to evaluate whether LIK066 can be developed for the treatment of     polycystic ovary syndrome (PCOS) in overweight and obese women.   "
10190|NCT03152578|"     This study consists of a randomized, double-blind, placebo-controlled crossover trial with     open label extension evaluating a topical natural health cream containing ß-caryophyllene     alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the     randomized controlled phase of the trial all participants will be given open-label     combination cream to be administered over the subsequent 3 weeks.      Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in     individuals who are experiencing pain due to osteoarthritis of the knee.      Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream     when used daily over 10 weeks.      Further evaluation will include overall patient satisfaction with the products tested.   "
10191|NCT03152565|"     Single arm Phase I/II multicentric open labeled, with translational sub-study, of avelumab     plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS)     metastatic colorectal cancer patients..   "
10192|NCT03152552|"     This is a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different     doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure   "
10193|NCT03152539|"     The main objective of the studies that will be carried out on volunteer patients who have     given their consent will be the development and optimization of the sequence parameters or     the design of the stimulation paradigms in order to optimize the quality and Relevance of the     images realized taking into account anatomical, functional or metabolic parameters. These     adjustments will be carried out without interfering with the management of voluntary patients   "
10197|NCT03152487|"     Pancreatic cancer is the second most common gastrointestinal malignancy. Abdominal discomfort     is a main symptom in patients with pancreatic cancer. Approximately 75% have pain at     diagnosis and over 90% in advanced stages. Pain control is an important part of the plan of     care for patients with pancreatic cancer/ Pain from pancreatic cancer comes from the celiac     ganglia and celiac plexus. The celiac plexus is a group of nerves that supply organs in the     abdomen. EUS-guided celiac plexus neurolysis (EUS-CPN) has been widely used for pain     management in patients with pancreatic cancer. Radiofrequency ablation of celiac ganglia     (EUS-RFA) is also routinely performed to alleviate abdominal pain in pancreatic cancer     patients. However currently no comparative studies exist comparing EUS-CPN with EUS-RFA. The     purpose of the study is to compare EUS-CPN with EUS-RFA for pain management in pancreatic     patients, in order to determine which technique is better at improving pain in pancreatic     cancer patients.   "
10198|NCT03152474|"     The study involves the participant to receive a 250 mcg Cortrosyn (ACTH) Stimulation Test to     test the ability of the body to make Cortisol. If the body is not able to make large amount     of Cortisol (Delta Cortisol < 13 mg/dl) from the stimulation test, then the participant will     be given additional cortisol like medicine called Solumedrol or matching placebo.      If the body is able to make large amounts of Cortisol (> 13 mg/dl), then the participant will     receive daily shots of Vitamin A for 7 days or matching placebo.      If the participant does not respond to the stimulation test, and meets the criteria for     Cortisol deficiency (all 3 cortisol concentrations < 20 mg/dl), then he/she will screen     failed for the study and will be offered hydrocortisone as part of routine care by the     treating physician.   "
10217|NCT03152227|"     This study aims at evaluating the impact of integrating nutrition sensitive behavioral change     communication (BCC) in the context of increased household production of chicken and eggs on     women and children diet.   "
10203|NCT03152409|"     The investigators are doing this research study to find out if using aspirin along with     antidepressant treatment can lessen symptoms of depression. This study also aims to find out     if some people improve more from taking aspirin than others. The investigators also want to     see if it is possible to predict which participants will do better based on a blood test.      Aspirin is approved by the U.S. Food and Drug Administration (FDA) as an over-the-counter     pain medication. But, aspirin is not approved by the FDA to make antidepressant treatment     better.      This research study will compare aspirin to placebo.   "
10204|NCT03152396|"     Cardiovascular disease (CVD) (disease of the heart and blood vessels) is one of the leading     causes of death and disability in Canada today. The majority of CVD cases are caused by     factors that can be controlled. These factors include tobacco use, obesity, high blood     pressure, high cholesterol, diabetes, and physical inactivity. Such factors are common and     not well controlled. Inflammatory arthritis (IA) (Inflammation of the joints and other     tissues) is considered another risk factor or CVD. As such, people who have IA and any of the     previously mentioned risk factors would be at high risk for developing CVD. Controlling these     factors will bring down the risk of having cardiovascular disease and make the quality of the     individuals' life better. Pharmacists work with patients and their family doctors to provide     cardiovascular care. Having a pharmacist involved in the care process may help patients with     IA reduce their CV risk. Pharmacists are easier to reach and may have more opportunities to     educate people about medications. This might lead to better prevention and control of     cardiovascular diseases.   "
10205|NCT03152383|"     The purpose of this study is to compare how children with autism, typically developing     children, and children with other developmental delays value social attention and toys. The     first part of the study seeks to determine whether breakpoints when responding on progressive     ratio (PR) schedules can be used to determine the value of leisure items and attention. By     comparing the breakpoints obtained for leisure items and attention, the researchers will     determine the differential valuation of leisure items and attention. It is anticipated that     the manner in which individuals with an autism spectrum disorder (ASD) diagnosis and those     who do not will differ with respect to the degree to which they value these two types of     stimuli. The second part of the study seeks to determine whether an intervention in which     social attention is paired with primary reinforcers impacts responding during the PR     assessment, in children with ASD.   "
10206|NCT03152370|"     This is a multicenter, open-label, Phase 1b study in participants with locally advanced     rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear     margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety,     to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in     combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of     the combination in the expansion part at RP2D.   "
10207|NCT03152357|"     This study is designed to evaluate implant survivorship, patient satisfaction, and     patient-reported outcomes of subjects who have undergone surgery with any of the following     ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement     Systems.   "
10208|NCT03152344|"     The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To     date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it     spends 20 to 30 minutes to complete.      The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up     and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for     frailty.   "
11016|NCT03141697|"     In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy     were assigned to either CO2 or air insufflation. We recorded basic characteristics of     colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out     questionnaires to record pain, abdominal bloating and flatulence.   "
10211|NCT03152305|"     An increase in intracranial pressure (ICP) during migraine attacks is possible and could     contribute to pain initiation and maintenance. From now on, it was not possible to measure     ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of     ICP variations. Thus, it is possible for the first time to look for such ICP variations     during migraine attacks and to conclude if this mechanism is implied in the pathophysiology     of migraine.   "
10212|NCT03152292|"     To examine the current disease progression of PDP, the clinical, economic, and humanistic     impact of anti-psychotic therapy in the management of the condition in real-world settings,     and the burden of the condition on patients and their caregivers   "
10213|NCT03152279|"     Increased intestinal permeability can represent compromise of the epithelium's integrity and     is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and     non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune     response. In this study, the investigators propose to use a novel, minimally invasive     technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium.     The primary aim of this study is to identify if there is a difference in duodenal mucosal     impedance between CeD and control patients.   "
10214|NCT03152266|"     Is the anatomical reduction of osteochondral impaction in the acetabular fractures will     improve the functional outcome? Despite the increasing amount of literature related to the     management of anteromedial dome impactions and marginal impactions, there are still remaining     issues and controversies pertaining mainly to the exact anatomy and location of the lesion,     the best method of reduction, the need and type of subchondral void filling, the best method     of stabilization, the need of reduction in elderly population and its true value as an     outcome prognostic factor.   "
10215|NCT03152253|"     This study will continue development of a quit smoking program delivered through text     messaging. Upon completion of programming we will enroll 280 participants and randomize them     to a control condition or the intervention condition. Assessments will occur at enrollment,     and both 3 and 6 month follow ups.   "
10216|NCT03152240|"     TAPAC study is an an investigator-driven, observational, prospective,cohort aimed at     evaluating differences between men and women in patients undergoing primary angioplasty :     hospital medical care, successful markers myocardial reperfusion and the anatomical substrate     by describing the underlying coronary anatomy will be compared.   "
10218|NCT03152214|"     Over 2 million soldiers have deployed during the Operation Enduring Freedom (OEF) and     Operation Iraqi Freedom (OIF) conflicts. While the majority of veterans reintegrate     successfully following deployment, a sizable minority return and face difficulties     transitioning into civilian life. There is surprisingly little research on disseminable     programs to facilitate reintegration, particularly outside of the formal VA healthcare     system. The primary objective of this project is to develop and evaluate an integrated     community- and exercise-based program that can be prescribed to augment existing transition     assistance programs.   "
10219|NCT03152201|"     During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM,     NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the     Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to     Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG)     activity with the same detection of locations.      For the purposes of the study the signals transmitted to the neurosurgeon through the     hardware and the corresponding assessments done by the neurophysiologist responsible for     intraoperative monitoring will be recorded. It will also be kept track of procedures     performed during surgery.   "
10220|NCT03152188|"     To evaluate the safety and tolerability of oral fecal transplant in patients with cirrhosis     and hepatic encephalopathy   "
10221|NCT03152175|"     Police officers and 911-operators are at increased risk for suffering from trauma-related     disorders due to their direct and indirect exposure to life-threatening events, such as     shootings, violent assaults, or car accidents, among others. Typical treatments for     post-traumatic stress disorders include psychotherapy and pharmacological therapies (i.e.,     antidepressants). Although these interventions are effective for many sufferers, they all     have limitations. Thus, the investigators propose to explore the usefulness of a new     therapeutic technique, reconsolidation blockade, which involves reactivating the trauma     memory while under the influence of propranolol. Objectives and hypotheses: To explore the     efficacy and cost-effectiveness of reconsolidation blockade therapy as an adjunct treatment     for trauma- and stressor-related disorders as defined in the Diagnostic and Statistical     Manual Mental Disorders-5. The investigators hypothesize that, compared to the control group,     5 weekly trauma-memory reactivations under propranolol treatment will confer a significant     reduction in trauma-related symptoms and significantly more health-related economic benefits.     Stress symptoms and health-related costs will be assessed at 7, 26 and 52 weeks after study     inclusion. In this study, the investigators will also explore the effects of reconsolidation     blockade with propranolol on various neuropsychological functions.   "
10222|NCT03152162|"     This is a prospective clinical study designed to observe the long-term clinical outcomes of     total knee arthroplasty using a patient-specific, posterior stabilized implant in patients     with osteoarthritis.   "
10237|NCT03151954|"     Hippo-YAP pathway is a newly discovered pathway controlling the growth, and plays important     roles in the regulation of stem cell function and tissue regeneration. Previously we found     that a higher expression of YAP in NP, and LPS was able to activate the hippo-YAP pathway in     NESCs. Thus, we hypothesize that the aberrant proliferation and differentiation of NESCs     could be regulated via the hippo-YAP pathway.   "
10238|NCT03151941|"     Our methodology is a feasibility study to determine the feasibility of assessing people in     the community with a neurological condition before proceeding towards a full powered     community trial evaluating the influence of intrathecal baclofen.   "
10239|NCT03151928|"     The validation study is intended to provide comparative data on the diagnosis of vaginal     infections as performed in primary care settings versus the diagnosis provided through     standard diagnostic testing performed in a reference laboratory. The clinician and lab     diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX     System.   "
10223|NCT03152149|"     This protocol describes a randomised controlled trial to test the hypothesis that 6 months of     treatment with tiotropium and olodaterol will result in a reduction in bacterial load, an     improvement in neutrophilic inflammation and clinical benefits compared with treatment with     inhaled fluticasone furoate and vilanterol in patients with neutrophilic Chronic obstructive     pulmonary disease (COPD).      COPD is the third leading cause of death worldwide and a major cause of morbidity in the UK.     Exacerbations drive disease progression and worsening quality of life and therefore     prevention of exacerbations has been a major goal of treatment.      In recent years, attempts have been made to phenotype COPD patients in order to target     therapies to the correct groups of patients that will benefit. Inhaled corticosteroids (ICS)     are primarily effective for patients with eosinophilic inflammation, while there are few     established therapies for patients with neutrophilic disease. In recent years, all ICS     preparations have been associated with a significant increased risk of pneumonia and this     risk appears to be greatest in patients with non-eosinophilic inflammation. Combined     treatment with long acting beta-agonists (LABA) and long acting muscarinic antagonists (LAMA)     combinations appears to be a safer and more effective alternative for patients with     non-eosinophilic disease. The combination of tiotropium and olodaterol in particular, has     strong preclinical data supporting beneficial effects on neutrophilic inflammation.      The trial is a multi-centre randomised open label controlled parallel group study with two     treatment arms in 80 participants. Moderate to very severe COPD patients and currently     treated with inhaled corticosteroid therapy will be randomised to treatment with either the     combination of tiotropium and olodaterol (LABA/LAMA) or fluticasone furoate and vilanterol     (ICS/LABA). Participants will return at 1 month, 2 months, 3 months and 6 months for sampling     of the lower airway by sputum samples and the upper airway using oropharyngeal and     nasopharyngeal swabs. Sputum will be used to test for airway neutrophilic inflammation.      This study will make an important contribution to understanding phenotyping in COPD by     identifying whether the combination of tiotropium and olodaterol improves airway bacterial     load and restores neutrophil function in patients with neutrophilic COPD.   "
10224|NCT03152123|"     The purpose of this study is to assess the abuse potential of single doses of pitolisant     relative to phentermine HCl and placebo, when administered to healthy, non-dependent,     recreational stimulant users.   "
10225|NCT03152110|"     Objectives: Spinal cord injury (SCI) is debilitating to an individual's health and functional     capacity and can significantly reduce quality of life. Specifically, SCI contributes to a     sedentary lifestyle and a subsequent elevated risk for preventable cardiometabolic and     hypokinetic diseases. While physical activity is strongly promoted in persons with SCI as a     means to reduce the incidence and development of secondary disabling conditions, a majority     of individuals with SCI are inactive and have low levels of fitness. High intensity interval     training (HIIT) is a form of exercise that is characterized by brief, intermittent bouts of     intense exercise, separated by periods of lower intensity exercise for recovery. The     magnitude of improvements in aerobic exercise capacity and other key cardiometabolic risk     factors following HIIT are similar to moderate-intensity continuous training, but only     require a fraction of the total energy expenditure and a vastly reduced time commitment.     Little research has been conducted on HIIT in persons with SCI, who are unique from other     special population groups due to their inability to carry out conventional lower limb HIIT     exercises. An upper extremity form of HIIT that is effective, safe, quick and has acceptable     positive affect could be an attractive option for persons with SCI who are not presently     exercising and have low fitness levels. The study will look at feasibility and acceptability     of a 6-week HIIT program for persons with a spinal cord injury who are untrained.      Methods: Investigators aim to test 10 individuals with spinal cord injury/dysfunction who are     untrained and use a manual wheelchair full time for mobility. Prior to starting any testing     or exercising, participants will be screened and will need to obtain a signed medical release     form from their physician. The screening procedure will include asking the participant the     inclusion/exclusion criteria and administering two short questionnaires related to physical     activity that will determine eligibility for the study. After obtaining the release form,     participants will be scheduled for their first visit. During Visit 1, participants will     complete baseline exercise testing and questionnaires. The study questionnaires will include     questionnaires related to sociodemographics, pain and health measures, general health and     function, and physical activity. Exercise testing includes an aerobic exercise stress test     (conducted following American College of Sports Medicine guidelines using an electronic     ergometer) and an anaerobic (maximum power output) test. After Visit 1, participants will     exercise three times per week for six weeks, following a standard HIIT protocol. Two of those     sessions will be supervised by a trainer, and one session will be completed on their own.     After the six week time period, participants will be scheduled for Visit 2 and will complete     the same evaluations as Visit 1. Additionally, participants will complete evaluations     measuring the level of satisfaction of the training program and their likelihood of     continuing the program.   "
10226|NCT03152097|"     The project will investigate the modulation of flavin-containing monooxygenase (FMO)     formation of the CVD risk factor trimethylamine-N-oxide (TMAO) in patients with kidney     disease.   "
10227|NCT03152084|"     The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by     Type 2 Diabetes Mellitus status and kidney function.   "
10228|NCT03152071|"     In this study the investigator will compare the effectiveness of robot assisted thoracic     surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer.      The perioperative circumstances and postoperative outcome will be compared.   "
10229|NCT03152058|"     This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug,     certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women     with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant     (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients     will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS     and repeatedly positive tests for LAC enrolled in a previous study by the investigators.   "
10231|NCT03152032|"     This multicenter retrospective cohort study examined the employment outcomes of the     innovative in-house vocational training (IHVT) programs for individuals with chronic     psychiatric disorders (CPD) and explored the program parameters significantly predictive of     the outcomes. The IHVT programs were government-funded services offered to newly discharged     inpatients or current outpatients with chronic psychiatric disorders (CPD) in four regional     psychiatric hospitals of Taiwan. Each program was staffed with occupational therapists and     paid or volunteer job coaches, along with cross-disciplinary support from psychiatrists,     psychologists, social workers, nurses, vocational specialists or others. Data were retrieved     from 323 participants with CPD who completed the IHVT and the 1st-, 3rd-, and 6th-month     follow-up interviews. The employment outcomes examined were the participants' employment     rates at the 1st-, 3rd-, and 6th-month post-training as well as their sustainability of     employment during the 6 months post-training.   "
10232|NCT03152019|"     The recognized manifestations of HHT are all due to abnormalities in vascular structure.     Epistaxis due to telangiectases formation is spontaneous, very variable, recurrent in 90% of     patients, and associated with severe anemia in 2-10%. They also significantly reduce quality     of life.      Improvement in epistaxis has been shown in HHT patients after a liver transplantation. It was     hypothesized that the immunosuppressive treatment (FK506) used to prevent rejection may have     an anti-angiogenic effect.      The results of Albiñana et al suggest that the mechanism of action of FK506 involves a     partial correction of endoglin and ALK1 haplosufficiency, genes responsible for 90% of HHT     case.      Tacrolimus ointment is available on the market for the treatment of eczema and can therefore     readily be used as it is for nasal administration. Topical nasal administration of tacrolimus     may be an easy local ENT treatment that is non-aggressive and results in little trauma for     the patient in relation to other first line treatment possibilities.      The main objective of this trial is to evaluate, at 6 weeks after the end of the treatment,     the efficacy on the duration of nosebleeds, of 6 weeks tacrolimus nasal ointment application,     in patients with HHT complicated by nosebleeds (30 min/6 weeks). Secondary objectives are to     evaluate the tolerance throughout the study, the efficacy on anemia and on clinical     parameters (nosebleeds, quality of life, epistaxis severity score questionnaire and blood     transfusions) and the systemic absorption of nasal administration.      This is a multicenter prospective and double blinded phase I/II trial. A total of 48 patients     will be randomized versus placebo using an allocation ratio of 1:1. The ointment (Protopic®     at 0.1% or placebo) will be self-administered by the patient with one administration in each     nostril twice a day for 6 consecutive weeks.   "
10233|NCT03152006|"     The purpose of this study is to evaluate the comparative effectiveness of a comprehensive,     coordinated transition protocol which includes an early introduction to the adult provider,     an integrated case management team and a peer-facilitated organized support group on     retention in care, viral suppression and psychosocial wellbeing among adolescents living with     HIV.   "
10234|NCT03151993|"     The aim of the study is to determine if single-bolus recombinant nonimmunogenic     staphylokinase is effective and save thrombolytic agent in with ischemic stroke in comparison     to alteplase.   "
10235|NCT03151980|"     Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is     removed. The investigators believe that partly removing a protective skin layer might     increase the risk of sun burn, especially for skin that has not been exposed to sun for a     long time.      The aim with this study is to assess if Hamam-treated skin is more susceptible to sun burn     compared with untreated skin.   "
10236|NCT03151967|"     The purpose of this research is to see whether LACTIN-V (Lactobacillus crispatus CTV-05) is     an effective method of preventing recurrent urinary tract infections (UTI's) and to learn the     side effects of LACTIN-V. LACTIN-V is a vaginal applicator that contains Lactobacillus     crispatus, an organism found naturally in the vaginas of healthy women. Lactobacillus     bacteria are thought to help prevent other bacteria such as E. coli from causing UTI's. This     is a double blind study comparing active product to a placebo (inactive vaginal applicator     without any medicine).   "
10240|NCT03151915|"     Twin-twin transfusion syndrome is one of the most severe complication in monochorionic twin     pregnancies and can cause severe impairment of fetal and neonatal outcome. In severe TTTS the     fetoscopic laser coagulation is the treatment of choice. Fetoscopic laser coagulation is     associated with a morbidity and mortality due to iatronic rupture of membranes as well as     iatrogenic placenta insufficiency. This can cause preterm delivery as well as intrauterine     fetal demise. An adaption of the fetoscopic tools to reduce the lesions of the amniotic     membrane can decrease the risk of PPROM and increase the overall survival.   "
10241|NCT03151902|"     Blood samples from urticaria patients will be analyzed for viral particles   "
10242|NCT03151889|"     Currently, cancer is a disease of high incidence, already considered a public health problem.     Among the most prevalent are head and neck neoplasms, and depending on the location and     extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that     have a great impact on the quality of life. Radiation therapy is a frequently chosen     treatment, and depending on the dose of radiation, causes changes such as hyposalivation.     There are techniques for salivary flow stimulation, however, most of the options involve the     use of medications, which limits administration to part of the patients. Transcutaneous     electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary     flow, however there is a limited number of studies that have tested this technique after     radiotherapy. The aim of this study was to verify the effect of TENS in increasing the     salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The     sample will have 80 patients randomly divided into two groups: TENS group and Control group.     In both groups, a quality of life questionnaire (UW-QOL) will be applied and a     speech-language assessment will be performed. The hypothesis of this research is that TENS is     effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of     the effect of this technique on the quality of life, mainly in the questions: speech,     chewing, saliva and deglutition.   "
10243|NCT03151876|"     The goal of this clinical research study is to evaluate effectiveness and safety of ChiCGB     regimen( chidamide, cladribine, gemcitabine and busulfan).      Busulfan are designed to kill cancer cells by binding to DNA (the genetic material of cells),     which may cause cancer cells to die.      Gemcitabine and cladribine are designed to disrupt the growth of cancer cells, which may     cause cancer cells to die. It may help to increase the effect of busulfan on cancer cells by     not allowing these cells to repair the DNA damage caused by busulfan.      Chidamide is designed to open up the DNA and allow greater access to drugs that bind to DNA,     such as cladribine, gemcitabine, busulfan.   "
11161|NCT03139812|"     This study sought to determine whether daily irrigation with sterile saline solution during     silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface     integrity and reduce the risk of adverse events.   "
10244|NCT03151863|"     Dexmedetomidine is allowed in Switzerland for intravenous (IV) medication in the intensive     care unit in the adult patient. Its active molecule, Dexmedetomidine (Dex), is a selective     and powerful α2-Adrenoreceptors (AR) agonist that shows the following complementary     properties: anxiolytic, sedative and analgesic. Moreover, it displays interesting     cardiovascular, respiratory and neuropsychic safety and tolerance profiles.      There is increasing number of promising studies for the use of intranasal (IN) Dex in     pediatric sedation due to its non-invasive nature, its efficiency and its rare secondary     effects. However, there is currently no information in the literature on the use of IN Dex in     elderly multi-medicated patients in palliative care.      In this end-of-life population, pain is controlled with administration of opioids.     Procedures, such as nursing cares, can generate pain and anxiety to the patient. Preventive     analgesia, subcutaneous (SC) opioids, is administered before the care. However, most of the     time, this additional dose fails to relieve the patient from his pain. In SPdol observational     study, 42% daily hygiene and comfort nursing care remained painful despite the administration     of a preventive analgesia.      IN Dex seems to be a good candidate for non-invasive analgesia and sedation in patients     admitted in palliative care before the nursing procedure.      In this study, the investigators compare the efficiency of IN Dex to the regular extradose of     SC opioids for analgesia before daily nursing care on elderly patients in the palliative care     unit.      The study design is a cross over, two-sided, superiority, double-blind, placebo-controlled     and randomized clinical trial.   "
10245|NCT03151850|"     We analyzed the diversity of the fungal and bacterial within colon mucosa between patients     with different degree of inflammation of Ulcerative Colitis.   "
10246|NCT03151837|"     This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the     efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects     with type 2 diabetes. A total of 40 subjects who meet the inclusion criteria and give written     consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or     (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Major enrollment     criteria include: (1)Subjects have confirmed type 2 diabetes and fail to reach the treatment     goal (fasting glucose 140-270mg/dL and hemoglobin A1c (HbA1c) 7-10%) after stable use of 1-3     oral hypoglycemic drugs for 3 months; (2)Subjects have stable diabetes mellitus (DM) history     with fasting glucose 140-270mg/dL and HbA1c 7-10% and refuse to use oral medications.     Efficacy outcomes include the changes in fasting glucose, Hb1Ac, and insulin sensitivity, and     safety assessments include liver and kidney function, and complains made by subjects after     the initiation of the investigational products (IP).   "
10247|NCT03151824|"     Quality of life (QoL) is an important factor for successful aging. Telomere length is an     indicator of cellular aging and cumulative biological stress and is thus related to health     status and survival. However, the relationship between QoL and telomere length has not yet     been examined. In this study we investigated the relationship between leukocyte telomere     length (LTL) and QoL.      However, the relationship between overall QoL and LTL has not previously been investigated.     Therefore, this study was conducted to examine the relationship between LTL and QoL. QoL was     measured by the Korean version of the 36-item short-form health survey (SF-36), which is a     multidimensional scale consisting of subjective evaluation.   "
10249|NCT03151798|"     The study will investigate whether the level of fat stored in the liver is related to the     liver's ability to burn fat.   "
10250|NCT03151785|"     60,000 people suffer an out of hospital cardiac arrest in the United Kingdom (UK) every year.     Bystander cardiopulmonary resuscitation (CPR) rates are dismal (30%) compared with places     where CPR education is mandatory for all school children (>50%). Strategies are needed to     increase these rates through innovative approaches. Lifesaver (www.life-saver.org.uk) is an     immersive interactive programme/application that presents such an opportunity. This study     aims to assess the effectiveness of Lifesaver on CPR attitudes, knowledge, skills acquisition     and retention in school children. Additionally, it aims to examine whether Lifesaver provides     additional benefits in terms of CPR attitudes, knowledge, skills acquisitions and retention     in school children when combined with face-to-face BLS training.   "
10251|NCT03151772|"     Neuro-oncological trials may fail due to the drug never getting to the intended target (i.e.     within the tumor micro environment). Also, changes' occurring in tumor cells when removed     from patients and grown in-vitro is another limiting factor influencing the clinical success.      Important questions are therefore:        1. Does the drug get there?        2. Does the drug do what it is intended to do?      To improve chances of clinical success there is a need for rational and intelligent selection     of potential drugs in future trials. This is an initiative for analyzing tumor concentration     of preoperative administered repurposed drugs   "
10252|NCT03151759|"     To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal     cancer patients.   "
10253|NCT03151746|"     The study's objective is to determine the efficacy of preoperative gabapentin in relieving     postoperative pain, reducing opioid use and improving quality of recovery in subjects     undergoing urologic surgery.      Investigators hypothesize that subjects receiving gabapentin will have lower pain scores,     less opioid consumption and better quality of recovery as compared to subjects who are given     a placebo.   "
10254|NCT03151733|"     Single incision laparoscopic surgery (SILS) is the further development of the concept of     minimally invasive surgery for colorectal cancer,which rapidly developed in the field of     colorectal surgery. Through the development of single hole laparoscopic colorectal cancer     radical surgery and clinical study and follow up accordingly, evaluating the feasibility,     surgical effectiveness and economy help to promote the popularization and application of     single hole laparoscopic techniques in the field.   "
10271|NCT03151512|"     This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and     brings together a team from UCL Division of Medicine, Computer Science and University College     London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical     algorithms to reduce the distortions in MR images, especially of the prostate.   "
10888|NCT03143400|"     The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus     salivarius, in the digestive tract of healthy volunteers and of ileostomized patients,     depending on its galenic form.      Two classic forms will be tested (powder and pill). An innovative galenic form (pill with     retarded release), developed to enhance intestinal viability and probiotic efficacy, will     also be tested.   "
10257|NCT03151694|"     This multi-national program applies a breakthrough approach to childhood obesity called,     Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the     investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls)     where Whole-of-Society (WoS) transformations are taking place (industrialized societal     context with peaking childhood obesity and where a broad governmental plan to promote healthy     lifestyle has been adopted -Canada; developing societal context with increasing childhood     obesity if replication of past pathways that have lead to double burden; India) are taking     place along with World Health Assembly (WHA) resolution A63-12 for marketing of food to     children. Individual-level BtS Diagnostic will examine the degree to which individual     differences in genetics and biology and differences in the environmental exposures modulate     the behavioral, body weight/fatness and nutritional risk over time in the context of WoS     transformations. Societal-level BtS Diagnostic shall examine the influence of decisions in     policy, investment, business and innovation made by different stakeholders (government,     private sector, civil society in health and non-health society systems including agriculture,     business and media practices) on the community.   "
10258|NCT03151681|"     Attachment injuries are events occurring within couple relationships that involve betrayal or     abandonment by a significant other during times of need (e.g., infidelity). They can be     understood as relationship traumas, which can lead to debilitating symptoms consistent with     posttraumatic stress disorder (PTSD), depression, and generalized anxiety for the injured     partner. Research has demonstrated that the presence of an attachment injury represents a     barrier to empirically effective couple's therapy. However, disrupting memory reconsolidation     with the beta-blocker propranolol has been shown to alleviate PTSD symptoms by attenuating     the salience of the emotional trauma memory, representing an interesting avenue for the     treatment of adjustment disorders stemming from attachment injuries. Here, the investigators     aim to extend the conditions under which reconsolidation therapy with propranolol can be used     in a clinical setting. The investigators hypothesize that 6 sessions of memory reactivation     under propranolol would significantly reduce trauma-related, depression, and anxiety symptom,     associated with an attachment injury.   "
10259|NCT03151668|"     Septic shock is one of the major causes of death worldwide with in-hospital mortality rates     varying between (11.9% to 47.2 %). Alterations in microcirculatory blood flow were associated     with high risk of organ dysfunction and death. Experimental studies on septic rats revealed     that dexmedetomidine treatment can effectively reduce the generation of inflammatory     mediators and yields beneficial effects on endotoxemic animals' microcirculation.   "
10260|NCT03151655|"     In this treatment development project, the investigators propose to develop and assess the     feasibility and acceptability of a narrative-based video intervention and accompanying     workbook (entitled MATTeRS: Medication Assisted Treatments: Telling Real Stories) designed to     be used by people in inpatient opioid detoxification. Using the Health Belief Model as a     framework, videos will provide information about the uses and outcomes of Medication Assisted     Treatments (MATs) compared to other or no post-detoxification treatment through the use of     narratives from real people's lives.   "
10277|NCT03151434|"     The purpose of this study is to compare three different pain control methods on subjects who     are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study     will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic     side effects.   "
10261|NCT03151642|"     The purpose of this research study will be to determine the sensitivity and specificity of     dwMRI metrics to assess tumor response following neoadjuvant chemoradiation in esophageal     cancer. This pilot study will generate the preliminary data needed for the design of a     statistically-justified trial that would investigate dwMRI as an integral biomarker to     stratify patients for escalated therapy to improve outcomes. We hope to develop dwMRI as a     predictive clinical tool for a personalized treatment model that can identify patients who     may be candidates for organ-preservation or treatment intensification to improve outcomes in     esophageal cancer.   "
10262|NCT03151629|"     Our intent is to establish the International Registry to Improve Outcomes in Men with     Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000     men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a     population-based registry and recruit patients across academic and community practices from     Australia, Brazil, Canada, Ireland, Sweden, Switzerland, the United Kingdom (UK), and the US.     Target accrual number and number of participating sites are subject to change based on     accrual, funding, and interest in participation by other international sites. This cohort     study will facilitate a better understanding of the variation in care and treatment of     advanced prostate cancer across countries and across academia and community based practices.      Detailed data will be collected from patients at study enrollment and then during follow-up,     for a minimum of three years. Patients will be followed prospectively for overall survival,     clinically significant adverse events, comorbidities, changes in cancer treatments, and     PROMs.      PROMs questionnaires will be collected at enrollment, every three months for the first and     second year then every six months.      Physician Questionnaires will be collected from all participating sites at patient     enrollment, time of first change in treatment and/or one year follow-up, at each subsequent     change of treatment, and discontinuation of treatment.      As such, this registry will help identify the treatment sequences or combinations that     optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at     enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free     DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes     of disease that predict response and resistance to specific therapeutics. Additionally, every     effort will be made to collect blood specimen at each subsequent change in treatment. When     feasible, existing tumor tissue may be collected for correlation with described blood based     studies. All samples will be used for future research. This cohort study will provide the     research community with a unique biorepository to identify biomarkers of treatment response     and resistance.   "
10263|NCT03151616|"     This study investigates the association of preoperative anticholinergic medication exposure     with healthcare resource utilization in a population-based sample of older patients enrolled     in a universal pharmacare program   "
10264|NCT03151603|"     It is well known that over-treatment of straightforward infections should be avoided as far     as possible. Evidence-based data on non antibiotic treatment options for common conditions     are therefore needed urgently. This randomised-controlled double blind trial examines whether     initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist,     reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a     negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients     presenting with typical UTI symptoms will be included by their GPs and receive randomised     either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial     antibiotic treatment. Patients record symptom severity and drug intake in a diary and     complete a final questionnaire after 28 days.   "
10292|NCT03151239|"     The purpose of the study is to understand the effect of the dietary supplement Nicotinamide     mononucleotide on metabolic health in women.   "
10272|NCT03151499|"     The primary objective of this trial is to investigate the relative bioavailability of BI     409306 tablets with prior 7-day intake of rifampicin tablets (Test, T) compared to BI 409306     tablets without prior administration of rifampicin (Reference, R) following oral     administration in healthy male subjects.      The secondary objective is the evaluation and comparison of several pharmacokinetic     parameters between the treatments. The secondary objectives will be assessed by descriptive     statistics.   "
10273|NCT03151486|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of     JNJ-55308942 in healthy participants after administration of single and multiple oral doses.   "
10274|NCT03151473|"     This is a 10-year, longitudinal, observational study of patients with NAFLD/NASH designed to     specifically address important clinical questions that remain incompletely answered from     registration trials. In addition to the study database, the biospecimen repository will also     be included so that translational studies of genomics and biomarkers of response may be     performed.   "
10275|NCT03151460|"     The study investigates the effect of dopaminergic stimulation over declarative memory     functions in Parkinson's disease (PD) patients. At this aim, 20 PD patients will receive     declarative memory tasks in two different conditions: after 12-18 hours of dopaminergic     stimulation withdrawal (off condition) and after the first daily dose dopaminergic therapy     (on condition). 20 healthy controls will also administered the two tasks in two conditions     with the same inter-session delay as PD patients, but without taking drugs.   "
10276|NCT03151447|"     The objective of this study is to evaluate the safety and tolerance of Stereotactic Body     Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in Metastatic Triple Negative     Breast Cancer   "
26645|NCT02936934|"     The objective of this study is compare adverse reactions associated with oxycodone and     morphine for the treatment of postoperative pain after abdominal hysterectomy   "
10278|NCT03151421|"     This is a European study which is part of a larger research project (The TackSHS project)     funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant     Agreement No 681040) and led by the Catalan Institute of Oncology.      This study will examine the efficacy of using personalised air quality measurements in homes     of smokers to encourage behaviour-change towards having a smoke-free home environment.     Building on recent quantitative and qualitative work showing that feedback of second-hand     smoke (SHS) measurement information can help motivate smokers to change their behaviour. This     study will develop a targeted intervention for use with socio-economically deprived smokers     in four countries (Scotland, Spain, Greece, Italy) across the EU. Two-hundred smokers (50 in     each country) will be recruited and offered low-cost, simple to operate particle counting     instruments to measure and log SHS levels in their home for a period of 30 days. During this     time near real-time, personalised feedback will be provided to, and discussed with, the     smoker along with target-setting and exploration of suitable methods of behaviour-change.     Feedback will be given via text message to mobile phones, emails and personal voice calls. A     final visit will gather data on changes made while a proportion of participants (10-20%) in     each country will take part in a further qualitative interview by phone to gather data on     their experience of the intervention.      Study outcomes will include quantitative measures such as changes in average and maximum fine     particulate matter (PM2.5) concentrations and self-declared household smoking rules, while     qualitative data will be gathered using questionnaire and interview to explore what elements     of the intervention were useful/unhelpful, particularly well/poorly understood, and what were     the barriers for those who did not make changes. This WP will provide a comprehensive     database of baseline measurements of SHS concentrations in home settings from across the EU     with the potential to generate over 8 million minutes of measurements of household air     quality. Analysis of the differences by country and possible determinants of exposure will be     carried out.   "
10279|NCT03151408|"     This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo     with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly     diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and     cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy     due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of     two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control     group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk     category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category     Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based     on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times     a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of     each cycle. Study treatment should continue until there is documented disease progression,     relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may     be required to achieve a complete remission. Once permanently discontinued from study     treatment, patients will enter the Long-term Follow-up phase of the study and will be     followed for assessment of disease progression, if applicable, and survival every 3 months     (±1 month) until death. The end of this study is defined when 390 events (deaths) have     occurred and the study is unblinded for final overall survival analysis. Patients who are     receiving study treatment at the end of the study may have the opportunity to continue to     receive the study drugs to which they were randomized to (Post- Study Observation Period),     until the Sponsor informs the Investigators of the appropriate course of action based on the     study results. The Post-Study Observation Period is defined as the period starting from the     end of the study for a maximum of 12 months.   "
10280|NCT03151395|"     Since the infectious aetiology of AECOPD has been suggested to vary according to geographical     region, the primary purpose of this study (which will be conducted in several countries in     Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of     stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of     COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and     duration of AECOPD, as well as the impact of AECOPD on health-related quality of life     (HRQOL), healthcare utilisation and lung function.   "
10281|NCT03151382|"     Objective: Evaluation the improvement of the cognitive function of tandospirone add-on     treatment on patients with AD comorbid anxiety.      Number of Patients: 30      Methodology: Randomized, open-label, parallel-group      Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control     group: Donepezil, 10 mg/d.      Effect Evaluation: Primary Outcome: Change from baseline in ADAS-cog total score at week 12;     NPI scale total score at week 12;   "
10282|NCT03151369|"     The relationship between visual pain score and perfusion index in postoperative patients.   "
10293|NCT03151226|"     Non emergent scheduled cesarean sections will be consented to participate in this study of     patients who have screened negative for obstructive sleep apnea and who are also BMI>/= 35 to     have capnography monitoring postoperatively. The capnography and pulse oximetry will be     initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data     will be retrieved after that time period in a deidentified fashion. Medication usage will be     reviewed as well as the standard of care information from the duramorph monitoring will be     retrieved.   "
10294|NCT03151213|"     The study aimed to investigate the preemptive analgesia efficacy of of preemptive pregabalin     for the postoperative pain management after radiofrequency ablation (RFA) of liver cancer.      DESIGN:      Prospective, randomized, placebo-controlled, double-blind study.   "
10283|NCT03151356|"     Prostate biopsies are the gold standard for prostate cancer (PCa) diagnosis. They are     performed according to the results of the measurement of prostate-specific antigen (PSA) in     the serum of patients with PCa suspicion. More than half of the prostate biopsies reveal     eventually negative because of the poor specificity of prostate-specific antigen assay. The     Prostate Health Index (PHI) is a new diagnostic tool that has been described as a good     predictor of prostate biopsy outcome. No large study has been performed so far in France.     This study aim to evaluate Prostate Health Index diagnostic performances in a large     multicentric French cohort of patients undergoing prostate biopsies because of clinical     and/or biological suspicion of prostate cancer.      Prostate Health Index will be measured in patients directed to prostate biopsies according to     usual practices. Inclusion of 400 patients within 6 months in 12 French centers is expected.     The ability of Prostate Health Index to predict prostate cancer at biopsy will be evaluated     in terms of intrinsic and extrinsic diagnostic performances including sensitivity,     specificity, predictive values, diagnostic accuracy, area under receiver operating curves and     decision curve analyses.   "
10284|NCT03151343|"     Patients with type 2 diabetes (T2 DM) have a markedly increased risk of heart disease and it     is estimated that, in the danish population, up 80% percent of patients with type 2 diabetes     die from heart disease.      The sodium glucose cotransport-2 (SGLT-2) inhibitors were developed as an anti-diabetic     therapy reducing blood glucose and weight by decreasing glucose reabsorption in the kidneys,     leading to glucose excretion via the urine. However, in 2015 the EMPA-REG study showed that     treatment with the SGLT-2 inhibitor empagliflozin significantly reduced the cardiovascular     mortality and risk of admission under the diagnosis of heart failure in a population of     patients with type 2 diabetes in addition to other risk factors for heart disease. The     mechanism behind this surprising result is unknown and warrants further study.      The primary hypothesis of the present study is that treatment with empagliflozin improves the     function and blood supply of the heart muscle cells in patients with type 2 diabetes and high     risk of heart disease. The investigators will test this hypothesis by enrolling 92     participants with type 2 diabetes and other risk factors for heart disease, and treating them     with either empagliflozin or a placebo. During the study period the investigators will     monitor the effects of the treatment with various techniques such as heart scans using CT and     ultrasound, measurements of the fluid pressures in the heart chambers, body composition     measurements and a variety of relevant blood test.   "
10295|NCT03151200|"     The purpose of this study is to assess the effectiveness of combining binocular treatment     with repetitive transcranial magnetic stimulation (rTMS) in improving the vision of adults     with amblyopia. This study also seeks to assess the effect of this combined treatment on     cortical neural function and functional connectivity.   "
10285|NCT03151330|"     Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term     disability throughout the world. Recently treatments early in pregnancy such as progesterone,     cervical support and maternal support have been demonstrated to delay delivery amongst at     risk women. Nonetheless, the majority of women who are at risk are not identified using     current screening modalities.      Hypothesis: Women who are screened using the PreTRM® test around 20 weeks gestation will have     a -statistically significant reduction in preterm birth compared to an unscreened historical     control group of preterm birth.      Study Design Type: Prospective cohort study of screened women compared to a historical     control. The study will employ an adaptive design allowing periodic evaluation of the data to     determine the optimal time to stop the study.   "
10286|NCT03151317|"     The primary objective of this study is to study the effect of therapeutic education on     patient adherence for at-home continuous positive airway pressure (CPAP) or at-home     non-invasive ventilation. This first study will use data already present in the Association     for Home Assistance and Rehabilitation (APARD) database to compare patients who received     therapeutic education with a control group who did not.   "
10288|NCT03151291|"     Patients suffering from cancer often experience a loss of muscle mass and strength during     disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer     cachexia syndrome and responsible for many therapy-related complications and a poorer     prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer     care. Physical exercise and nutrition are promising measures to combat cancer-related muscle     atrophy but conventional exercise programs may not always be suitable for physical-weakened     patients and increased catabolic processes are difficult to overcome by normal Nutrition -     especially in advanced cancer. Therefore, the present study aims to test a combined approach     of specific nutritional supplementation and exercise using the novel strength training method     of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week     WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB),     L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle     mass, body composition, physical function, nutritional and inflammatory status, fatigue and     quality of life in cancer patients undergoing oncological treatment. The results of this     study may help to clarify the effectiveness of those combined interventions to counteract     muscle wasting and other symptoms of cancer cachexia.   "
10289|NCT03151278|"     This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic     approach with conventional fluoroscopic approach as performing catheter ablation of right     atrial arrhythmias.   "
10290|NCT03151265|"     The objective of this Investigator Initiated study is to evaluate the effectiveness of     ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in     participants experiencing pain, reducing pain during movement. This study is an intervention     trial on two discrete subject samples; (1) people with recent back pain, and (2) people who     regularly play sport. ViMove wearable sensors provide precise objective measurements of low     back muscle activity and movement in real time and can capture a patient's reporting of pain     during movement. Outcomes will be assessed through standard ViMove protocols in conjunction     with multiple validated measures of pain, perception of change, and function.   "
10291|NCT03151252|"     Currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal     tract are scarce. The endoscopic segmental Lavage is the method of choice, but it´s     controversial.      Additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the     mucosa cells and biopsies are taken. Comparative to the Lavage specific IgE antibodies, Tumor     necrosis factor- alpha, Eosinophilic cation protein and mastcell tryptase were measured.   "
10296|NCT03151187|"     The investigators have initiated an education program for residents on the diagnosis and     management of disruptive behavior disorders in children. These will be presented as two     2-hour modules to be delivered at an academic half-day for pediatric trainees across Canada.     We plan to evaluate the effectiveness of the curriculum by administering a pre and post test.     Pediatric residents in Canada all participate in a practical assessment of their skills (an     Observed Structured Clinical Examination or OSCE). The investigators plan to develop on OSCE     station which assesses the curriculum and randomize programs to do the curriculum either     before or after the OSCE. This will help us determine how effective the curriculum is at     teaching about disruptive behaviours.   "
10297|NCT03151174|"     The goal of this study is to determine whether Vitamin D supplementation improves strength     and bone density, and reduces the risk of injury in collegiate athletes.   "
10298|NCT03151161|"     EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, icotinib,has been recommended     as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients'     progression-free survival. The OPTIMAl trial indicated that those who received TKI and     chemotherapy during the whole treatment window survived longest. Unfortunately, previous     studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed     to improve survival in unselected patients. To avoid the potential synergistic antagonism,     the FAST-ACT II trial committed a sequential strategy and find a superiority in the     combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the     continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could     obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.      On the basis of these and other studies, the investigators hypothesized that a better     sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out     window before chemotherapy) would be more efficacious than chemotherapy alone. In this study,     the investigators investigate the efficacy(PFS:progression free survival), safety, and     adverse-event profile of chemotherapy plus intermittent and maintenance of icotinib compared     with icotinib single drug, when these drugs were used as first-line treatment in who had     non-squamous lung carcinoma with EGFR gene mutation in China.   "
10299|NCT03151148|"     The purpose of this study is to examine the safety and effectiveness of a new therapy,     commensal lotion containing infection fighting bacteria, on decreasing or eliminating the     infection causing bacteria found on the skin of Atopic Dermatitis (AD) patients.   "
10300|NCT03151135|"     Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with     Anorexia nervosa.   "
10301|NCT03151122|"     The objective of the study is to establish a continuous nurse-led integrated support program     and to exam its impact on preterm infant neurodevelopment.      Research hypotheses include:1. The continuous nurse-led integrated support will have     significant impact on preterm infant neurodevelopment; 2.The support program will also have     positive effect on parent psychological well-being.   "
10302|NCT03151109|"     This study will look at patient radiographic and functional outcomes who have or will undergo     a reverse, extended peg, shoulder arthroplasty (replacement) that requires the use of glenoid     bone grafting.   "
10303|NCT03151096|"     Hypertension, which results from a combination of multiple lifestyle and genetic factors, is     a global public health problem affecting 1 billion people worldwide. The identification of     cheap treatment interventions without adverse side effects would be hugely advantageous     particularly in low-income settings with high prevalence of hypertension such as sub-Saharan     Africa where up to 46% of adults are affected.      Emerging evidence links a functional polymorphism in the MTHFR gene (rs1801133 C677T),     encoding the folate-metabolising enzyme methylenetetrahydrofolate reductase to high blood     pressure in adults. Variation at rs1801133 is relatively common and has 3 genotypes;     homozygous normal CC, heterozygous CT and homozygous variant TT genotypes. Of these     genotypes, the homozygous variant TT is more strongly associated with a higher BP. The     precise mechanism by which MTHFR is associated with BP remains unclear. It has been recently     shown in 3 separate randomized controlled trials that BP is highly responsive to riboflavin     and that this response is differential by MTHFR rs1801133 genotype. In all these clinical     trials, significant reduction in both systolic and diastolic blood pressure was observed in     the homozygous variant TT genotype and an intermediate effect seen in those with the     heterozygous CT genotype. The aim of this study is to evaluate the effect of riboflavin     supplementation on blood pressure in a riboflavin-deplete population as well as comparing     plasma riboflavin status before and after supplementation. This will be achieved by     conducting a randomized single-blind placebo controlled trial over a period of 16 weeks.      The Investigators will use the Keneba biobank to invite about 100 adults with the CT genotype     and a similar number of age-, sex and village-matched CC homozygotes. Participants within     each of the groups will be randomized to receive either riboflavin (5mg/d) or a matching     placebo which would be supplied on a weekly basis. Blood sample, blood pressure measurement,     socio-demographic data and their anthropometric measurements (height, weight, waist and hip     circumference and body composition by BIA) will be taken during the initial visit. An     additional blood sample will be taken at the end of the study whilst additional BP     measurements will be taken respectively at 8 weeks and at the end of the intervention. The     possibility that riboflavin deficiency represents a new, easily-correctible causal factor in     hypertension in sub-Saharan Africa would require further large-scale interventions if this     pilot study yields encouraging results.   "
10304|NCT03151083|"     Internet-based self-help programs are personalized, self-guided interventions delivered over     a computer, mobile device, or other Internet platform and focused on improving knowledge,     awareness, or behavior change for a mental or physical health problem. Through previous and     on-going projects at VACT, the investigators are developing a general strategy for     implementing Internet-based Self-help programs in VA primary care, specifically among Patient     Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An     implementation strategy is defined as a systematic intervention to integrate evidence-based     health innovations into usual care. The strategy the investigators propose to test consists     of four core components: (1) a clinical intermediary for patient support, (2) provider/staff     facilitation and education, (3) patient education, and (4) stepped-care for those requiring     additional treatment. In the proposed study, the investigators will compare this strategy to     a low intensity (control) strategy with respect to the implementation related outcomes of     patent engagement, provider adoption through referral to the program, and patient completion,     over a six-month active implementation period. The investigators will target the very common     clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program     utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic     insomnia. The program has been shown to improve insomnia severity and other sleep related     outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be     evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month     active implementation periods. The purpose this study is to evaluate the preliminary (1)     effectiveness of an implementation strategy for Internet-based Self-help Interventions and     (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM,     in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental     implementation strategy the investigators are developing, relative to a control strategy,     will result in higher rates of program engagement by patients, greater provider adoption     through referral to the program, greater program completion, and improved patient insomnia     outcomes.   "
10335|NCT03150680|"     The purpose of the research project is to investigate the potential association of 207     genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX     score), along with the patients' response to clopidogrel and statin therapy. The aim of the     study is to combine genetic, pharmacogenetic, clinical and laboratory data in order to create     an algorithm (GEnetic Syntax Score-GESS) that will enable an individualized therapeutic     patient approach.   "
10305|NCT03151070|"     ¡Que Vivan las Madres!: Venga a tener su parto al CAP (QVLM) is a guatemalan     quasi-experimental study that has been performed from January 2014 to January 2017 by the     Epidemiological Research Center in Sexual and Reproductive Health (CIESAR) in Guatemala in     coordination with PRONTO International and University of San Francisco, California. This     project has been financed by Grands Challenges Canada' Save Lives at Birth, A Grand     Challenge for Development partnership that includes USAID, Norwegian ministry of foreign     affairs, Bill&Melinda Gates foundation, UKaid. This project has applied a stepped wedge     design (SWD) over 6 zones or clusters. Each one of the zones contains from 4 to 6     communities, each one with the presence of one second level health facility (known in Spanish     as CAP, Centro de Atención Permanente). These health centers are the next level in attention     after home, traditional and empirical attention. Communities around the selected health     centers are mostly rural and have the worst maternal health indicators in the country. These     health centers are expected to have enough equipment and personnel to attend the deliveries     that occur in their communities. This study was performed in Huehuetenango and Alta Verapaz     districts in north Guatemala. Each one with 3 zones for a total of 6 zones. The study follows     a Stepped Wedge Design, in which all 6 zones are eventually intervened, but at different     regular periods of time (each period is 4 months long). This project applies a package of 3     simultaneous interventions in each zone with the purpose of increasing institutional     deliveries and improving deliveries attention in public health centers. This intervention     plan has been implemented in a pilot study reported in (Kestler et. al, 2013).   "
10306|NCT03151057|"     This is a Phase 1 study to evaluate the safety of idelalisib as post-transplantation     maintenance in patients with B cell hematologic malignancies undergoing a reduced intensity     conditioning (RIC) allogeneic BMT. Safety will be evaluated through the assessment of     cytopenias, effect on donor chimerism, effect on the incidence and severity of acute graft     versus host disease, and gastro-intestinal tolerance.   "
10307|NCT03151044|"     This clinical trial is designed to compare the efficacy and safety of R±CEOP90 containing     high-dose epirubicin and R±CEOP75 containing standard epirubicin in newly diagnosed young     patients with medium/high-risk diffuse large B-cell lymphoma. Half of the participants     receive R±CEOP regimen containing 90mg/m2 epirubicin, while the other half of participants     receive R±CEOP regimen containing 75mg/m2 epirubicin. Via exploring whether high-dose     epirubicin shall achieve better efficacy and less toxicity, we hope to optimize current     treatment choice for young patients with medium/high-risk diffuse large B-cell lymphoma.   "
10308|NCT03151031|"     The purpose of this study will determine the effect of cryotherapy applied to the knee joint     on static and dynamic standing balance. It is hypothesized that there will be no change in     dynamic postural stability after cryotherapy application.Twenty four individuals (age 18 to     30) participated in the study. They will be randomly divided into two groups, experimental     and control group. Each participant, in the experimental group will be asked to perform star     excursion balance test (SEBT) under two conditions, before and after the application of     cryotherapy. The participants will receive ice pack wrapping of the knee for 10 minutes. The     control group performed SEBT at room temperature in an interval of 10 minutes. The two group     will be analysed and compared   "
10309|NCT03151018|"     The objectives of this study are        1. To establish a prospective registry of the whole patients who received percutaneous          coronary intervention with Resolute Onyx™ stent.        2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute          Onyx™ stent.        3. To compare the long-term efficacy and safety of coronary stenting between the Resolute          Onyx™ stent and other contemporary drug-eluting stents which had established their own          registry.   "
10310|NCT03151005|"     Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of     childbearing age, which is usually characterized by hormonal imbalance and metabolism     problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral     contraceptives, which effectively reduces circulating androgens and are treatment for     hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1     Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and     weight control by inhibiting of gastric emptying and reducing food intake. This study aims to     evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35     combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic     ovarian syndrome (PCOS) patients.   "
10311|NCT03150992|"     A feasibility study to provide 'proof of concept' of Elemental Diet (ED) as an acceptable/     useful feeding option for patient with inoperable malignant bowel obstruction and to examine     the impact of ED on quality of life   "
10312|NCT03150979|"     Previous studies failed to determine the real effects of the provision of a walking cane     after a stroke, mainly due to biases related to their methodological designs. In addition,     there is no information on the carry-over effects of a cane to social participation. This     study will test the hypothesis that the provision of a cane is effective in improving gait     speed, step length and cadence, locomotion ability, and social participation of individuals     with chronic stroke. For this prospective, single-blinded, randomized clinical trial, people     after stroke will be randomly allocated into either experimental or control groups. The     experimental group will receive a single-point cane, with ergonomic handgrip, which will be     individually adjusted to the participant's height. A physiotherapist will provide     instructions on how to walk with the cane and the participants will practice for about 30     minutes or until they feel comfortable with the device. Then, they will take the cane home     and will be instructed to use it all the time during locomotion. Weekly, they will receive a     phone call, to ensure that they are using the cane and to clarify any doubts. A home visit     may be conducted, if necessary. The control group will be instructed to perform stretching of     the upper limb muscles daily and keep their daily activities, without the use of a cane. To     ensure the level of attention similar to that of the participants in the experimental group,     the individuals in the control group will also receive weekly phone calls. At baseline, post     intervention, and two months after the cessation (follow-up) of the interventions,     researchers blinded to group allocations will collect all outcome measures.   "
10336|NCT03150667|"     To compare clinical outcomes in patients with chronic kidney disease (CKD) presenting with an     acute coronary syndrome (ACS) treated with clopidogrel or ticagrelor (both FDA approved and     guideline indicated drugs for treating these patients upstream managed medically or with     coronary revascularization).   "
10313|NCT03150966|"     Multiple sclerosis is the most common autoimmune disease of the central nervous system, most     ranging in age from 40-20 years of age is associated with neurons inflammation and     demyelination. Increasing aggressive activities of Th17 and Th1 cells that their function is     to secrete proinflammatory cytokines and decreasing the number and activity of regulatory T     cells, which normally leads to controlling inflammation, are seen in these patients.Curcumin     is a polyphenol. Curcumin binding with a range of protein and the have ability to inhibit the     activity of various kinases. Curcumin has a combination of activities such as antioxidant,     anti-proliferation, anti-invasive, and can used in the treatment of Alzheimer's, Parkinson's,     Multiple sclerosis, Cardiovascular disease, Bacterial diseases and Arthritis.   "
10314|NCT03150953|"     Patients under deep sedation and general anesthesia lose heat to their surrounding     environment. Hypothermia after anesthesia is associated with worse patient outcomes,     including increased number of infections and cardiovascular complications. Cardiac MRI scans     performed for patients who require general anesthesia can cause a loss of body heat.      Several mechanisms exist for reducing hypothermia under anesthesia including forced air     warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no     MRI-compatible systems which allow patient warming and prevention of hypothermia in     anesthetized patient in the MRI-scanner.      This study is testing a non-invasive device that warms patients under clinically indicated     general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI     scanner.   "
10315|NCT03150940|"     This is a study supported by Duke Sports Cardiology and Duke Sports Medicine with the intent     to enhance the cardiovascular screening of collegiate athletes from a regional to nationally     recognized program to understand and eventually reduce cardiovascular events in athletes. The     data from this ongoing registry will be used to better understand, refine, and improve the     current cardiovascular Duke Athlete Screening process and use this experience as a role model     to expand across the ACC.   "
10316|NCT03150927|"     This study is to determine if a novel bio-fermented Microbiotic Composite™ can improve the     digestive health and subsequent growth and quality of life parameters in a selected group of     children in a district in India.   "
10317|NCT03150914|"     This is a study to determine if early, long-term low dose sirolimus is effective for     preventing progression to more advanced stages.   "
10318|NCT03150901|"     Diabetic patients with a history of diabetic foot are considered to be a high-risk population     for increased cardiovascular and all-cause mortality (1,2,3,). Diabetic foot (DF) is     responsible for more hospitalizations than any other complication of diabetes and are the     leading cause of non-traumatic lower extremity amputations, resulting in nearly 100 000     amputations annually in the US alone (4,5,6). Surgical debridement, as an important component     of standard of care of diabetic foot, is intended to remove healing-impaired tissue,     decreases bacterial burden, thus to stimulate overall wound closure, while removing as little     of healing-competent skin as possible. Furthermore, debrided tissue is often used as a     valuable tissue source for research purposes (7,8,9,10). Debrided tissue presents valuable     diagnostic and research source to verify pathology, assess prognosis and gain insights into     DF molecular pathology, all of which ultimately leads to improved outcomes.      We aimed to validate tissue obtained from surgical debridement of DF for the     cellular/molecular tissue analyses and biomarkers, to evaluate the pathophysiology of DF and     understanding mechanisms that inhibit healing.      The age range will be 50-70 years, in order to minimize the effects of irreversible vascular     wall changes induced progressively by the aging process. All patients will undergo screening     procedures that will include full anamnesis, physical examination, basic laboratory blood     tests (full chemistry, CBC); urine examination and EKG will be performed at start and at the     end of the study. Patients with a significant myocardial, and renal, cerebrovascular or     hepatic disease will be excluded from the study.      In a prospective study, we will collect wound edge tissue specimens from 75 patients with DF     during surgical debridement. From each patient, 1-4 specimens will be obtained per     debridement. To evaluate debrided tissue, each specimen will be processed for paraffin     embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple     specimens acquired from the same wound will be analysed.   "
10319|NCT03150888|"     The purpose of this study is to construct hypertension specialized cohort using uniform     standards and specifications. This study timely collected multi-dimensional clinical     information through electronic medical records, mobile health, data integration, informatics     and computer modern techniques, linking self-reported data and big data platforms from     different sources to timely obtain the incidence and mortality data, and integrating     hypertension cohort samples and the associated clinical records systematically, in order to     build a 30-thousand hypertension specialized cohort with fine phenotypic data and blood/urine     samples, thus far to provide support for the development of precise medicine research and     related industries.   "
10320|NCT03150875|"     Similar clinical trial results demonstrated that anti-PD-1 antibodies prolonged OS to     approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in     Chinese non-squamous NSCLC patients will be investigated in this clinical trial.      Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in     Chinese non-squamous cell NSCLC as well as the role of irRECIST in immune checkpoint     inhibitor treatment evaluation will also be assessed   "
10321|NCT03150862|"     This study is to evaluate the safety, efficacy and clinical activity of BGB-290 in     combination with radiation therapy (RT) and/or temozolomide (TMZ) in subjects with newly     diagnosed or recurrent/refractory glioblastoma.   "
10322|NCT03150849|"     Chronic lymphocytic leukemia is the most common type of chronic leukemia, accounting for     approximately 40% of all leukemias and mainly affecting older individuals. As it has a highly     variable clinical course, identification of molecular and biological prognostic markers has     provided new insights into the risk stratification of patients with chronic lymphocytic     leukemia.   "
10323|NCT03150836|"     This is a multi-site, randomized, prospective, open-label phase II study. Patients in this     study will have localized (cT3-cT4), or metastatic bladder cancer with a symptomatic, intact     primary bladder tumor. In this study, patients will undergo stereotactic body radiation     therapy (SBRT) to the bladder tumor and will receive durvalumab with or without tremelimumab.   "
10337|NCT03150654|"     It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect     macular pigment as well as inner layer cells in the retina, so it was aimed to investigate     possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical     density in diabetic retinopathy patients without macular edema and pathology in this study.   "
10695|NCT03145909|"     This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose     (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary     efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid     tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose     Escalation and Expanded Recommended Phase 2 Dose.   "
10324|NCT03150823|"     Electrical stimulation currently has a wide range of clinical applications, being used for     activities such as strengthening, pain control, edema management, or inflammation control     after injury or surgery. One of the classic forms of electrotherapy is the Direct current     (galvanic current), which stands out for its unique effects (polar and interpolar effects)     and that are not achieved with other modalities of electrotherapy. Within these effects those     activators or suppressors of nervous system activity are described. One of the applications     of direct current is to produce sedation or excitation on the nervous system through     longitudinal applications (longitudinal galvanization). This application technique is known     as the upstream or downstream effect of the direct current or Leduc Effect, in which it is     postulated that an ascending type longitudinal galvanization has excitation effects of the     central and / or peripheral nervous system. The study will evaluate the influence of the     upward and downward direct current effect when performing a manual dynamometer test while     monitoring by miofeedback in college students.   "
10325|NCT03150810|"     This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and     temozolomide (TMZ) in subjects with locally advanced or metastatic solid tumors.   "
10326|NCT03150797|"     This will be a randomized, multi-site double-blind placebo-controlled trial of melatonin (2     different dosing arms) vs. placebo for migraine prevention in adolescents. We intend to     enroll approximately 210 participants over 15 months at two sites: UCLA and UCSF. The     duration of participation for each participant will be 4 months.   "
10327|NCT03150784|"     The importance of play and physical activity include many benefits on positively improving     health and well-being, enhancing children's and young people's thinking and performance in     school, improving their sleep and enabling confidence and skill building. However, some     children find it hard to learn and perform motor skills, and are at risk of decreased     participation in sports and physical activity and subsequently decreased physical fitness and     overall health and well-being.      Previous studies from the research group have explored the impact and recovery following     acute exercise at different intensities in children and adolescents with and without movement     difficulties. Following this, a pathway promoting physical activity and engagement has been     successfully established within schools for those with and without movement difficulties.     Taking the previous studies further, we want to specifically focus on the children's     performance and learning of a sporting skill, such as stepping, and the associated brain     activity changes, using available high resolution imaging techniques. This will help us     understand how these children perform and learn motor and sporting skills. Evidence obtained     from imaging alongside measures of movement has helped the development of optimal therapeutic     approaches for other conditions such as stroke and Parkinson's and will help us to develop     approaches to help children best learn motor skills and hence gain confidence in performing     sporting activities.   "
10328|NCT03150771|"     This trial will determine the Pharmacokinetics, safety and tolerability of single-dose     Aripiprazole administered intramuscularly in adults with schizophrenia   "
10329|NCT03150758|"     Erectile dysfunction persists in approximately 80% of men 1 year after prostatectomy. Various     erectile rehabilitation strategies have not provided benefit. Electrical stimulation has been     demonstrated to benefit neuroregeneration and the functional recovery of neuromuscular     systems. Therefore, electrical stimulation of the cavernosal nerves during radical     prostatectomy is being investigated for its potential development into a treatment aimed at     improving recovery of erectile function after prostatectomy. This pilot study is intended to     determine the threshold of electrical stimulation that results in penile erection, as defined     by persistent intracavernosal pressure increase, such that future studies of sub-threshold     stimulation may be pursued.   "
10330|NCT03150745|"     Endocervix (cervical canal) is the cavity of the cervix and connects the external os with the     internal os. It is fusiform in shape and has posterior and anterior oblique longitudinal     ridges, the plicae palmatae. These are not exactly apposed but inter-lock like a zipper so     that the canal is kept closed.      The original squamous epithelium is clearly identified as a smooth, usually featureless     covering of the cervix; its uniform pink color contrasts with the redness of the original     columnar epithelium. It joins the latter at the original squamocolumnar junction.      Many clinicians encounter cervical lesions that may or may not be associated with cytologic     abnormalities. Such abnormalities as ectropion, Nabothian cysts, and small cervical polyps     are quite benign and need not generate concern for patient or clinician, whereas others,     including those associated with a history of exposure to diethylstilbestrol, cervical     inflammation, abnormal cervical cytology, and postcoital bleeding, should prompt additional     evaluation. Further, in some patients, the cervix may be difficult to visualize. Several     useful clinical suggestions for the optimal examination of the cervix are presented.   "
10331|NCT03150732|"     Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients     undergoing hand surgery.   "
10333|NCT03150706|"     The POLE mutations represent high somatic mutation loads in patients with colorectal cancer,     especially in those with MMR proficient or MSS, therefore, tumors harbouring POLE mutations     might be susceptible to immune checkpoint blockade.      Based on these reasons, Investigator planned a phase II study of avelumab monotherapy in     patients with previously treated, metastatic, MMR deficient (MSI-H) or POLE mutated     colorectal cancer.   "
10334|NCT03150693|"     This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin     and how well it works when given with frontline chemotherapy in treating patients with newly     diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab     ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used     in chemotherapy work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving     inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute     lymphoblastic leukemia.   "
10393|NCT03149900|"     To identify possible genetic associations of clinical response to anti-IL-17A (Secukinumab)     treatment in psoriasis using a combined gene association study and gene expression analysis.      To investigate the influence of IL-17A on the cutaneous microbial flora and to analyse     cutaneous antimicrobial peptide expression in the skin of patients with psoriasis prior to,     and during, treatment with Secukinumab to determine the extent to which the microbial flora     is associated with response to treatment, as determined by the PASI75, PASI90, PGA- and DLQI     improvement.   "
10338|NCT03150641|"     After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta     and the mother. The best time to cut the umbilical cord of full term babies is unknown.     Traditionally, the umbilical cord is cut immediately at birth. There is however, continued     blood flow from the placenta to the baby after delivery and so there may be a benefit to the     baby from waiting to cut the cord until one minute after delivery. Studies show that delaying     cutting the cord until at least one minute after delivery increases a full term baby's blood     count in first two days of life and increases the baby's iron levels. The impact of delaying     cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord     has minimal impact on the mother's health when the baby is delivered vaginally, but it is not     known how delaying cutting the cord impacts the mother's health (and specifically the amount     of blood a mother loses at delivery) when the baby is delivered by cesarean.      The purpose of this research study is to find out how delaying cutting the umbilical cord     until one minute after delivery of the baby during a cesarean impacts the amount of blood the     mother loses during surgery. The study will also examine the benefits to the newborn from     delayed cord clamping during cesarean.   "
10339|NCT03150628|"     Rationale: For patients with peritoneal metastases of gastric origin, there is no consensus     on the optimal treatment strategy. Several Asian and Western studies demonstrated     hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CS) to result in     a prolonged survival compared to palliative systemic treatment. Morbidity and mortality rates     of HIPEC and CS appear to be acceptable. In the Netherlands, this treatment is not yet     introduced, therefore patients with peritoneal metastases of gastric origin are precluded     from surgery and will be treated with palliative chemotherapy or best support of care.      Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with     peritoneal metastases of gastric cancer, in terms of morbidity and mortality. Secondary     objective is to determine the effect on survival and recurrence.      Study design: Mono centre prospective phase II single-arm feasibility study.      Study population: Western patients diagnosed with resectable (cT1-4b, N1-3) gastric cancer     with clinical or pathologically proven peritoneal metastases without distant metastases.      Intervention: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Cytoreductive Surgery     (CS) with Cisplatin.      Main study parameters/endpoints: Primary outcome is the safety and feasibility of the     intervention, measured by the percentage of overall surgical complications grade ≥3 as stated     by the Common Terminology Criteria for Adverse Events. Secondary outcomes are intraoperative     events, postoperative morbidity and mortality, postoperative recovery, including quality of     life, and disease free- and overall survival.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The additional burden for the patient mainly consists of HIPEC and     CS.Furthermore, patients will undergo additional staging in order to exclude unresectable     disease, and neoadjuvant chemotherapy regimen (3 drugs) instead of a palliative chemotherapy     regimen (2 drugs). Postoperative care and outpatient visits are performed according to     current protocols on HIPEC and CS for colon cancer and nation-wide protocols on gastric     cancer surgery. The study is associated with a high risk classification. As there is a     potential survival benefit, a small chance for curation and possibly a higher quality of     life, we consider the additional burden and risks justified. This study is designed as a one     group study, which eliminates group relatedness.   "
10340|NCT03150615|"     Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer.     PD is still associated with a relatively a high incidence of delayed gastric emptying. And,     there are no acknowledged strategies to avoid DGE. Several feeding strategies have been     investigated to cope with this problem. However, there is still no consensus concerning the     best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to     determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early     enteral nutrition or total parenteral nutrition.      Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral     nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural     control). The EN group will receive standard enteral diet administered through a nasojejunal     tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by     20-40 ml up to the estimated level. The Saline group will receive saline administered through     a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be     restricted in all three group.   "
10341|NCT03150602|"     This study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients     after prior treatment failure, as determined by independent imaging reviewer(s) using     international workshop lymphoma response criteria (IWC)   "
10342|NCT03150589|"     This is a randomised, double-masked, parallel group, multicentre study to evaluate the     efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in     subjects with neovascular AMD.   "
10343|NCT03150576|"     This neoadjuvant trial for patients with TNBC and/or gBRCA breast cancer, aims to investigate     the safety and efficacy (improvement in pathological Complete Response at surgery) of     concurrent platinum-based chemotherapy with olaparib an inhibitor of the PARP enzyme (PARPi).   "
10344|NCT03150563|"     Intensity is a qualitative variable of a muscle stretching protocol, which is very little     studied due to its inherent characteristic of the individual being stretched. However, it was     pointed out as an important factor for ADM gain. To verify the effects of different     intensities of static passive stretching on flexibility, neuromuscular and functional     performance in soccer athletes.   "
10345|NCT03150550|"     Among behavioral cognitive psychotherapies, new Mindfulness interventions allow patient to     identify, pay attention and accept external (sensory stimuli) and internal (cognition and     emotions) phenomena. This to do with training has yielded promising results in stress     management, prevention of depressive relapse, management of craving and an increase in     self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this     technique on alcohol relapse, in particular by comparing it with a usual management strategy     (conventional relapse prevention therapy).      The main objective of this study is to compare the efficacy on alcoholic relapse (measured in     the first glass consumed), from a Mindfulness therapeutic program to a conventional Relapse     Prevention program. Secondary objectives are to demonstrate the efficacy of this program on     craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of     alcoholisation days).   "
10346|NCT03150537|"     80 subjects (healthy adults) will be randomized to receive the seasonal flu vaccine either by     needle & syringe or by the MIT needle-free injector. The study will be conducted after the     normal flu season has passed (ie: March-April). Half of those randomized to standard     vaccination (n=20) will receive vaccine drawn from a multi-dose vial while the other half     (n=20) will receive vaccine drawn from a single use vial. The same vaccine as the multi-dose     vial will be delivered to the other half of the subjects (n=40) using the MIT injector. How     long it takes to prepare and deliver the vaccines will be assessed (a time-motion study).     Subject acceptance before and after injection will be assessed as well as local and systemic     side effects. Standard serologic measures of immune response to flu vaccination (ie:     antibodies) will determine whether the MIT injector induces the same kind of immune response     as needle & syringe delivery.   "
10348|NCT03150511|"     The aim of this clinical trial is to assess the efficacy of tesamorelin as a therapy for     peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will     allow for faster and greater recovery of motor and sensory function following surgical repair     of injured peripheral nerves. Patients with upper extremity nerve injuries will be randomly     assigned to receive either the drug or a placebo (inactive drug). A number of tests for nerve     regeneration, muscle function and sensation will be performed every month for a total of 12     months. Outcomes in the patients treated with tesamorelin will be compared to outcomes in     patients who received the placebo to determine the effectiveness of tesamorelin as a therapy     for nerve injuries.   "
10349|NCT03150498|"     This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating     females. The study will consist of up to 2 parts; the decision to proceed to the optional     second part will be made following review of Part 1 data.      Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.      Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK     profile of BTD-001   "
10350|NCT03150472|"     Ivory Dentin Graft is at least as good as the reference test device (OsteoBiol Gen Os) for     alveolar ridge preservation following tooth extraction.      The null hypothesis is that Ivory Dentin Graft and OsteoBiol Gen Os are not equivalent (Gen     Os is better than Ivory Dentin Graft) and the alternative hypothesis is that the proportions     in the two groups are equivalent, assuming that the expected difference in proportions is 0.0     (Ivory Dentin Graft is as good as Gen Os Graft).   "
10351|NCT03150459|"     The main purpose of this study is to investigate whether the combination of two different     drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated     cirrhosis.      The secondary purpose is to see if this combination results in an improvement in inflammation     markers in patients with cirrhosis and in an improvement in analytic parameters of     progression of liver disease.   "
10352|NCT03150446|"     The aim of this study was to evaluate the role of flexible cystoscopy in preventing     malpositioning of the ureteral stent after laparoscopic ureterolithotomy in male patients.      From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter     underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy     performed by four different surgeons. In the last 50 patients who underwent laparoscopic     ureterolithotomy flexible cystoscopy was performed through the urethral route to confirm the     position of the double-J stent, while in the first 47 correct positioning of the stent was     confirmed through postoperative KUB.   "
10353|NCT03150433|"     This is a study testing the effects of behavioral sleep interventions on pain and brain     function in sickle cell disease.   "
10354|NCT03150420|"     This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate     the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute     calciphylaxis-associated pain in chronic hemodialysis patients.   "
10355|NCT03150394|"     Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able     to penetrate and colonize the stomach mucosal lining by infecting it.      The eradication treatment of H. pylori is supported by numerous consensus groups worldwide     and it is generally safe and well tolerated. Standard treatment is based on multiple drug     regimens. However, its effectiveness has been increasingly compromised due to the emergence     of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a     randomized, double-blind, placebo-controlled study whose aims are:        1. Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will          improve gastrointestinal symptoms when associated with four-way therapy (of any type).        2. Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to          reduce the gastrointestinal adverse effects of quadruple eradication therapy.      They will be determined by the GSRS gastrointestinal symptom scale in routine clinical     practice.   "
10356|NCT03150381|"     This study tests evidence-based strategies for weight loss among overweight and obesity     cancer survivors and family members in rural Alabama.   "
10357|NCT03150368|"     This is a study for extended use of ModraDoc006/r in patients with advanced solid tumours,     available after completed treatment in one of the phase I trials with ModraDoc006/r. The     primary goal is to explore the safety of extended use.   "
10358|NCT03150355|"     hip fractures are common problem specially in elderly population the incidence is increasing     nowadays because of increased incidence of motor vehicle accidents   "
10359|NCT03150342|"     Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic     cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT)     cameras with solid-state cadmium-zinc-telluride (CZT) detectors have been shown to decrease     imaging time and improved the imaging quality of gated myocardial perfusion imaging (MPI).     The investigators also correlate the MPI parameters with echocardiographic parameters. This     study is to examine the spatial distribution of stress perfusion abnormalities and tissue     injury in patients with HCM using a CZT SPECT camera.   "
10360|NCT03150329|"     This phase I trial studies the side effects and best dose of vorinostat when given together     with pembrolizumab in treating patients with diffuse large B-cell lymphoma, follicular     lymphoma, or Hodgkin lymphoma that has come back after a period of improvement or that does     not respond to treatment. Monoclonal antibodies, such as pembrolizumab block cancer growth in     different ways by targeting certain cells. Vorinostat may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Giving vorinostat and pembrolizumab     together may work better in treating patients with diffuse large B-cell lymphoma, follicular     lymphoma, or Hodgkin lymphoma.   "
10361|NCT03150316|"     This study is to determine the maximum tolerated dose(MTD) and recommened phase 2 dose(RP2D)     based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile     of a single agent CKD-581 injection in Combination with Lenalidomide and Dexamethasone in     patients with Previously Treated Multiple Myeloma.   "
10629|NCT03146936|"     The investigators wish to collect high quality prospective data on a rare disease in order to     elucidate epidemiology, natural history, response to treatment and outcome. In addition, a     biobank allows addressing specific scientific issues on a variety of open questions. The     cohort will provide a platform for carrying out scientific research projects on PSC. In     addition, the cohort will allow collaborations with reference networks on PSC abroad   "
10362|NCT03150303|"     Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least     1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for     an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon     taking part to the study will be included in this prospective observational study.      The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events     during the peri-procedural period (between 5 days before surgery plus 30 days after the     invasive procedure).      0. The secondary end-points will consist of identifying risk factors for bleeding during the     peri-procedural period, risk factors for thromboembolic events during the peri-procedural     period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers     involved in the possible change of anticoagulant prescription prior the oral surgery All     outcome events will be blindly adjudicated by a central independent adjudication committee.   "
10363|NCT03150290|"     Weight loss is a common phenomenon in ALS. During the course of the disease, difficulty in     swallowing and mastication can be responsible for a decrease in caloric intake and thus for     weight loss. However, significant weight loss can also be observed in patients with no     feeding difficulties. About half of ALS patients have an increase in their resting energy     consumption, but the origin of this hypermetabolism remains unknown. Brown fat is     specialized in the production of heat. Unlike white fat that stores excess caloric intakes,     brown fat consumes energy. In humans, brown fat has long been considered as absent in adults.     However, recent imaging techniques have been able to detect brown fat deposits in some adult     subjects. The aim of this study is thus to determine the role of brown fat on energy     consumption in Amyotrophic Lateral Sclerosis.   "
10364|NCT03150277|"     The main purpose of this study will be comparison of acute effects of plyometric and heavy     resistance exercise on post-activation potentiation   "
10365|NCT03150264|"     This study compares the two mechanical ventilation strategies in obese patients undergoing     bariatric surgery: pressure-controlled ventilation(PCV) and pressure-controlled ventilation     volume-guaranteed（PCV-VG). This is a randomized controlled trial with a sample size of 140     patients whose body mass index(BMI) is over 30kg/m².   "
10366|NCT03150251|"     One objective of this study is to examine the blood glucose and serum insulin responses over     2hr elicited by oats soaked overnight in milk compared to Cream of Rice soaked overnight in     milk and compared to Cream of Rice cooked in water. In addition a second objective of the     study is to measure subjective ratings of hunger and fullness under the same conditions.   "
10367|NCT03150238|"     The project will consist of a multicentre, prospective, observational study with a total     duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a     dedicated database (on IG-IBD Register), which will be used to identify potential clinical,     endoscopic and ultrasound risk factors of re-operation. These data could be merged into a     shared score, to stratify patients according to the risk of post-surgical re- operation and     to define an optimal therapeutic management in the post- operative period. Approximately 220     adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the     previous 6 months will be enrolled.   "
10368|NCT03150225|"     The aim of this study is to analyze the impact of physical exercise through a protocol of     concurrent training in the psychological, physical, hormonal and sexual aspects in middle     aged men with androgen deficiency in the aging male (ADAM). The study design with randomized     clinical trial, comprising men in middle age (40 to 59 years) with ADAM, should be divided     into two groups: 1) Control group (CG); 2) Experimental group (EG). Information related to     sociodemographic and clinical profile will be collected; Psychological aspects (depressive     and anxiety symptoms - Hospital Anxiety and Depression Scale ; stress - Perceived Stress     Scale); Physical acpects (IMC; Percentage of body fat; Abdominal obesity - waist     circumference in cm; Muscle strength - Biodex System 4 PRO isokinetic dynamometer;     cardiorespiratory Fitness - Cycle-ergometer - CASE ECG Stress Testing System, General     Electric Medical Systems, Milwaukee, WI); Hormonal aspects (total and free testosterone -     blood collection); Sexual Aspect (Sexual satisfaction- International Index of Erectile     Function); DAEM (scale of symptoms of aging). Apply a physical exercise protocol using the     functional training method over a six-month period. All information will be collected before     and after the intervention period. For statistical analysis, use the SPSS statistical     package, version 20.0. (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of     statistical tests.   "
10369|NCT03150212|"     The main objective is to assess the effect of an 8-week daily supplementation with IbSium®     (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal     disorders associated to the type C IBS (constipation predominant).   "
10370|NCT03150199|"     The focus of this study is to examine the feasibility, acceptability, and impact of a     customized, combined positive psychology and motivational interviewing (PP-MI) health     behavior intervention versus a standard motivational interviewing (MI) intervention in a     group of patients with type 2 diabetes (T2D).   "
10379|NCT03150082|"     This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500     mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under     fasting conditions. Subjects will receive Treatment A (GR37547 tablet) and Treatment B     (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at     least 7 days and not more than 14 days. The total duration of study for each subject will be     approximately 5-7 weeks. This study will enroll approximately 26 healthy adult subjects at a     single center.   "
10380|NCT03150069|"     The present study seeks to interview women with Morquio A and Morquio B syndrome, to explore     their concerns surrounding pregnancy and the impact of ERT on their perspectives, in     comparison with the control group of Morquio B subjects for whom no ERT treatment exists.      Interviews will be conducted by a health psychologist, in-person or over the telephone. Data     will be analyzed using MAXQDA 12.0 software and Grounded Theory. Differences in thematic     trends between Morquio A subjects, for whom treatment exists, and a control group of Morquio     B subjects, for whom there is no treatment, will be compared.   "
10799|NCT03144557|"     This study evaluates the implementation of an education protocol and its impact on the     correct inhalation technique in COPD patients presenting errors or mistakes. There will be 4     sessions, in each one the inhalation technique will be evaluated using a checklist of steps.     Whenever errors are found, the correct use of each device will be educated through verbal     explanation and written material will be delivered.   "
10371|NCT03150186|"     This is a European study which is part of a larger research project (TackSHS project) funded     by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement     681040) and led by the Catalan Institute of Oncology. The main goal of the study is to assess     the environmental levels of secondhand smoke (SHS) in non-regulated settings such as private     and outdoor settings of 12 European countries (Bulgaria, France, Germany, Greece, Ireland,     Italy, Latvia, Poland, Portugal, Romania, Spain and the United Kingdom) representing     geographical, legislative (country-specific smoke-free policies) and cultural variations     across Europe.      This is a multi-country cross-sectional study based on objective environmental measurements     of SHS levels. Private settings studied are homes and cars and outdoors settings are terraces     of hospitality venues, children playgrounds and entrances of primary school buildings. A     total of 1,080 environmental measures of airborne nicotine will be collected. 20     environmental measures will be collected from homes and each of the outdoor settings for the     12 countries involved in the study (960 samples). Regarding cars, 60 environmental     measurements will be collected in two countries (Spain and the UK) (120 samples), which have     been selected taking into account differences in smoke-free legislation. Further information     about SHS exposure will be collected for each setting through brief questionnaires or forms.     Medians and interquartile ranges of nicotine concentrations will be calculated by country for     each setting studied. Nicotine concentrations will be compared using non-parametric tests     according to country, socioeconomic status and other determinants of exposure for each     setting.   "
10372|NCT03150173|"     This trial will recruit syringe exchange participants with opioid use disorder in New York     City and test whether starting buprenorphine treatment at the syringe exchange program is     more effective than referral to a community health center for buprenorphine treatment.   "
10373|NCT03150160|"     The purpose of this study is to determine the incremental intraocular pressure (IOP) lowering     that is achieved when brinzolamide 1% / brimonidine 0.2%, BID, is used adjunctively to     travoprost in patients with normal tension glaucoma that may benefit from further intraocular     pressure lowering.      Data from this study will result in publications and provide health care practitioners with     important treatment guidance on the use of brinzolamide 1% / brimonidine 0.2% in this     clinical setting.   "
10374|NCT03150147|"     The overall aim of this proposal is to compare a new state-of-the-art ex-vivo organ     preservation method with standard ischemic cold static storage of donor hearts in adult     cardiac transplantation.      Standard heart preservation before transplantation consists of cold ischemic storage of the     heart. Clinical studies has shown that the morbidity and mortality risk increases with     extension of the allograft ischemic time over four hours. For each additional hour the     mortality risk increase with 25% the first year. This time constrained is costly and results     in severe logistical problems, leading to loss of transplantable organs.      Initially six patients will be transplanted with the non-ischemic hypothermic cardioplegic     perfusion. These will be compared with contemporary control patients transplanted with     standard ischemic cold static storage. After an interim analysis, the study will become a     single center, prospective, open, blinded endpoint, randomized, controlled clinical trial     including 28 patients. The primary end-point is a composite of mortality, primary graft     dysfunction (PGD), need for extra corporal support, or acute cellular rejection (ACR) within     30- days post-transplant. PGD and ACR will be accessed blinded.An improved preservation of     the transplanted organ will reduce the major limitations for survival in the early     post-transplant period such as non-specific graft failure and acute rejection. Furthermore,     it will make it possible to increase the donor pool.   "
10375|NCT03150134|"     Early reduction of immunosuppressive agents after HLA matched donor transplantation can     improve the survival of advanced stage acute myeloid leukemia.      single-center, open clinical study   "
10376|NCT03150121|"     Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific     mortality, since they do not offer early enough detection of the disease. Most cases of high     grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for     high-risk populations (e.g., BRCA1/2 mutation carriers) is to undergo risk-reducing bilateral     salpingo-oophorectomy (RRBSO) around the age of 40. The aims of this trial are: (1) to     identify novel early-stage disease biomarkers using liquid biopsies obtained through uterine     lavage, and (2) to optimize the technique a of uterine lavage and the processing of the     samples for ultimate implementation as a routine diagnostic test for high risk populations.   "
10377|NCT03150108|"     The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy     adults of Japanese descent and matched, healthy Caucasian adults.   "
10378|NCT03150095|"     Ability to adhere to complex medical regimens is critical to achieving successful transplant     outcomes, as non-adherent patients suffer graft failure and death following transplantation.     Since potential recipients greatly exceed organ availability, identification of candidates     who will adhere to complex post-transplant regimens is critically important and emphasized by     practice guidelines. When selecting candidates for transplant, physicians try to subjectively     predict post-transplant adherence because, although tools exist to measure current adherence,     tools that reliably predict future adherence are lacking. Despite rigorous medical and     psychosocial screening pretransplant, non-adherence rates are high following transplant.     Therefore, the current approach for predicting future non-adherence is suboptimal,     subjective, and greatly needs strategies for improvement.      Pre-transplant self-management abilities represent a marker of future adherence     post-transplant. Assessing self-management as a means for predicting future adherence has     been largely overlooked. Self-management is defined as taking responsibility for one's own     behavior and well-being and consists of three management tasks: medical condition, emotions,     and social roles. Self-management ability can be measured. However, self-management has not     been systematically studied in heart and lung transplant patients. Fostering self-management     abilities may improve post-transplant outcomes by optimizing not only adherence, but also     proven pretransplant risk factors (e.g. frailty and obesity).Self-management abilities may be     improved via behavioral interventions such as health coaching.Self-management represents a     measurable criterion that could be utilized in pre-transplant screening and serve as a point     of intervention for optimizing adherence and pre-transplant risk factors.The overall     objective of the proposed research is to improve the knowledge gap regarding self-management     (and thereby adherence) in transplant by qualitatively and quantitatively studying patient     factors associated with self-management and testing an intervention that may improve     self-management.      The investigators hypothesize: Individualized health coaching including strategies to address     poor resilience, coping with uncertainty, frailty, and/or negative affect will be an     effective therapeutic strategy at improving self-management while in the pre-transplant     state.      Specific Aim: To test whether transplant candidates who receive pre transplant health     coaching have greater improvement in self-management abilities.      The investigators will conduct a randomized, controlled pilot trial testing the effectiveness     of health coaching versus usual care in a heart and lung transplant cohort on self-management     abilities (SMAS-30).   "
10708|NCT03145740|"     This study is a randomized controlled trial (RCT). Patients after severe acquired brain     injury (ABI) were randomised in addition to the individual daily rehabilitation program to     intensive Facial Oral Tract Therapy (F.O.T.T.®) (intervention group) or unspecific treatment:     washing face, brushing teeth, without facilitating swallowing (control group).      The duration of the intervention period was 15 working days (3 weeks). The intervention in     both groups was twice a day.   "
10381|NCT03150056|"     The study aims to evaluate the combination of GSK525762 with other agents that have been     shown to be effective in the treatment of CRPC or metastatic CRPC, including approved agents     (e.g., abiraterone, enzalutamide) as well as investigational agents for mCRPC that have     proven to show efficacy and can be combined based on complimentary mechanism of action. As a     first step, the combination of GSK525762 will be evaluated as a combination with abiraterone     or enzalutamide in men with metastatic or advanced castrate-resistant prostate cancer who     have progressed on at least one line of prior androgen receptor (AR)-targeted therapy. This     study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose     (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in     combination with either abiraterone (Arm A) or enzalutamide (Arm B). Arm A and Arm B will     further have 2 cohorts: A1, A2 and B1, B2 respectively based on prior lines of therapy (L2     [chemo-naive subjects treated with a second androgen-deprivation therapy] and Lx [subjects     treated with both prior androgen-deprivation therapy and chemotherapy]). During dose     escalation, both the treatment arms (A and B) will follow a modified Toxicity Probability     Interval (mTPI) design. Approximately 130 subjects will be enrolled worldwide in this study.     Subjects from both dose escalation and dose expansion may be combined to reach 30 subjects.     The total duration of study will be approximately 2 to 3 years. A subject will be considered     to have completed the study if they are followed until death.   "
10382|NCT03150043|"     A non-invasive hemoglobin monitor will be used during cesarean delivery and the values     obtained will be compared to values obtained from traditional blood draw.   "
10383|NCT03150030|"     Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be     recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along     with a control group of twenty-one individuals with normal glucose tolerance matched for age,     gender, and body mass index. Patients with type 2 diabetes will be scheduled for a three-week     run-in period with LR and CGM prior to participation in Part 1. Only patients with a     well-functioning loop-recorder and who can comply with CGM will be included. Patients with     type 2 diabetes will continue in part 2 of the study, a one year observational study     employing CGM and LR and clinical examination after 1, 3, 6, 9, and 12 months and an extended     observation period of 2 years employing LR and clinical examination.   "
10384|NCT03150017|"     To establish the effectiveness of an internet-delivered cognitive behavioural therapy pain     management programme (CBT-PMP) on people with spinal cord injury pain compared with usual     care.   "
10385|NCT03150004|"     This is a prospective phase II clinical study to be conducted at the Medical College of     Wisconsin. After meeting the study criteria and enrollment, patients will be treated with     CLAG-M chemotherapy and followed at periodic intervals to determine the primary and secondary     objectives.   "
10386|NCT03149991|"     This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of     brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable,     and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive     Disorder with Treatment Resistant Depression.   "
10387|NCT03149978|"     This study suggested an effective application of pattern recognition, which figured the     possible biological function of potential bio-markers of rectal cancer found in our study     based on their chemical structures. Hence, this study identified the precursor protein and     metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation     of locally advanced rectal cancer   "
10388|NCT03149965|"     The hypothesis was that the anovaginal distance (AVD), defined as the distance between the     anal mucosa and the vaginal wall at the middle level of the anal canal, is higher in obese     women compared with normal weight women. Measuring the AVD with transperineal ultrasound has     been shown to have a high interobserver agreement.      This study aimed to establish if there was a difference in AVD measured by transperineal     ultrasound between obese and normal weight women in active phase of labor at term pregnancy.     The second aim was to present normal values for the AVD in active phase of labor at term     pregnancy.   "
10389|NCT03149952|"     Hospitalization for allogeneic haematopoietic stem cell transplantation constitutes a     particular time in the management of patients with malignant hemopathies both for the     patient, for his entourage or for the nursing staff. For the patient, the strict protective     isolation set up during this period is a source of isolation in the broad sense and is     associated with an escape from external events and society. It also constitutes a physical     barrier (mask, charlotte, surblouse and overshoes worn by caregivers or visitors) and even     psychological in relations with relatives. Moreover, this period is also difficult because of     the possible complications of conditioning (mucositis, transit disorders, fever ...) and     allograft itself (graft versus host disease, no transplant, relapse disease…). The patient     may be weakened and diminished, which can give a feeling of helplessness and uselessness to     the family. Finally, this therapy can have serious physical and psychological consequences     for the patient and his entourage (especially in the case of family allograft) who do not     always have the possibility to express themselves verbally. Published studies in hematology     report depressive, anxious and post-traumatic stress disorders in patients and relatives     during allogeneic haematopoietic stem cell transplantation. It is therefore important to     reduce these symptoms, particularly those related to the cut-off during hospitalization for     allogeneic haematopoietic stem cells.      Over the last decade or so, the logbook has been used in some resuscitation services in     intubated patients, with the main objective of filling the memory gap mentioned by the     intubated patients when they woke up and limiting the trauma associated with this Cut in the     world corresponding to the sedation period. For this purpose, the use of a logbook in     Hematology, by analogy with what is used in the resuscitation services, could be a means of     limiting the psychological complications related to the allograft.   "
10390|NCT03149939|"     Hyperuricemia is not infrequently encountered among hemodialysis patients. However, there is     no clear data about use of febuxostat among hemodialysis patients, apart from very small case     series. The aim of this study is to investigate the efficacy of using febuxostat for the     treatment of Hyperuricemia among hemodialysis patients.   "
10391|NCT03149926|"     The current study investigates the emotional response of patients with borderline personality     disorder and healthy controls on stimuli associated with self-injury.   "
10392|NCT03149913|"     Patients with claudication or critical limb ischemia will be treated either with uncoated     balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or     occluded below the knee arteries   "
10402|NCT03149783|"     A randomized controlled trial to determine if pre- and post- operative regional pain control     (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic     and narcotic dosing, and alters pain scores.      This study plans to learn more about regional anesthesia and pain control during abdominal     surgery. The study will gather data about the effectiveness of continuous catheter infusion     of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain     medicine requirements, and delirium.   "
10394|NCT03149887|"     Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for     postoperative pain control after total knee, total hip and total shoulder arthroplasty. We     are conducting a randomized, controlled trial to evaluate pain control after arthroscopic     rotator cuff repair in ambulatory patients, comparing standard care in the control group,     with standard care plus the addition of injection of liposomal bupivacaine in the     experimental group.   "
10395|NCT03149874|"     The aim of this study is to examine the result of seroprotection using the accelerated     vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis     A and B vaccine.   "
10396|NCT03149861|"     Background:      Currently, patients suspected of having prostate cancer undergo ultrasound-guided systematic     biopsies of the prostate. However, up to a quarter of clinically significant tumors, which     may pose a risk to patient's well-being, may be missed on random biopsies. MRI enables     detection of further tumors in this patient population, but also has limited accuracy.      Study hypothesis:      We hypothesize that hybrid PET-MRI, a novel scanner which incorporates MRI with molecular     imaging will improve the detection rate of clinically significant tumors.      Study design:      In this prospective trial, we will recruit 57 men who are suspected of having prostate cancer     but have had negative systematic biopsies, who have been diagnosed with low-risk disease but     have clinically signs of more aggressive tumor or who have a focal tumor detected and are     candidates for minimally-invasive tumor ablation (=tumor destruction with laser or ultrasound     waves), in whom it is crucial to exclude other tumor sites.      All patients will undergo PET/MRI after injection of a radiopharmaceutical called     18F-DCFPyL. This is a radioactive probe which has been shown in preliminary studies to be     sensitive and specific for detection of prostate cancer.      All lesions detected on PET/MRI will undergo biopsy under ultrasound using fused PET/MRI and     ultrasound images for guidance, and compared to histopathology. The primary outcome measure     in this study is the proportion of clinically significant prostate cancers that are detected     with PET/MRI compared to MRI alone. Improved detection of clinically significant prostate     cancer may enable a tailored, personalized therapeutic approach, decreasing morbidity and     potentially improving overall patient outcome.   "
10397|NCT03149848|"     This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in     healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the     pharmacokinetics of oral cabotegravir (CAB) 30 milligram ( mg). This study will evaluate the     drug-drug interaction (DDI) potential between CAB and RBT to inform dosing strategies for     tuberculosis in subjects receiving CAB for human immunodeficiency virus (HIV) treatment or     prevention. In Treatment Period 1 (Treatment A) participants will receive CAB 30 mg once     daily for 14 days, followed by Treatment Period 2 (Treatment B) where participants will     receive RBT 300 mg once daily with CAB 30 mg once daily for 14 days. The total study duration     will be approximately for 10 weeks. Approximately 15 healthy subjects will be enrolled to     ensure that 12 subjects complete dosing and critical assessments.   "
10398|NCT03149835|"     Objectives: Investigate the acute NIV effects on CBF and cognitive functions in COPD     patients. Methods: Nine non-hypercapnic stable COPD subjects (FEV1/FVC < lower limit of     normal) and twelve healthy controls were enrolled. CBF (transcranial Doppler), cognitive     functions, respiratory and cardiovascular response were tested at baseline, during and after     non-invasive ventilation.   "
10399|NCT03149822|"     This study is designed to evaluate the combination of pembrolizumab and cabozantinib in     subjects with locally advanced, recurrent, or metastatic renal cell carcinoma that has     progressed after treatment with at least one prior VEGF-targeted therapy, or for whom     VEGF-targeted therapy has proven to be intolerable, or is considered inappropriate.   "
10400|NCT03149809|"     The impact of urinary symptoms in Parkinson disease (PD) extends beyond worsened well-being.     Urinary symptoms common in PD, especially incontinence and nocturia, are major risk factors     for falls likely due to the combination of urinary urgency and impaired mobility (and falls     are a leading cause of mortality in PD), for spouse/caregiver stress due to decreased     mutuality in the relationship, and for institutionalization, largely due to increased     disability. Additionally, most medications currently recommended for urinary symptoms in PD     are anticholinergic and have the potential to worsen the progressive cognitive and autonomic     burdens of the disease. Veterans with PD are also more likely to rely solely on VA for their     health care than Veterans without PD. Thus, optimizing the care of urinary symptoms for     Veterans with PD becomes imperative, particularly for VA. Using a non-inferiority design,     this proposal seeks to demonstrate the comparative effectiveness of pelvic floor muscle     exercise-based behavioral therapy versus drug therapy to treat urinary symptoms in PD.   "
10401|NCT03149796|"     The investigators propose to identify changes in cytokines like adipocytokines and microRNA     (miR) expression (for example miR-9, miR-16, miR-125, miR-132, miR-146a, miR-150, miR-155,     miR-181 and miR-223) in peripheral blood leukocytes and in serum samples obtained from     rheumatoid arthritis (RA) patients before and after tocilizumab treatment. The results     obtained will be compared to gender- and age-matched healthy controls, and will help the     investigators define one or more miRNAs as biomarkers for treatment effectiveness.      Methods The investigators will obtain blood samples from 60 RA patients treated with     tocilizumab, according to the local clinical guidelines. Blood samples will be collected     before treatment, as well as one and four months following tocilizumab treatment. The blood     samples will initially undergo microarray analysis and then the results will be confirmed for     specific miRNAs by quantitative real-time PCR (qPCR). The serum level of the tested     cytokines, like adipokines, will be measured using ELISA methods. The changes in cytokines     level and miRNAs expression, either up-regulation or down-regulation, during tocilizumab     therapy will be correlated to the severity of the disease and to specific demographic and     medical data. The results obtained will be compared to 60 healthy controls gender- and     age-matched   "
10421|NCT03149536|"     In this study, the investigators will evaluate genetic variation or polymorphisms between     individuals submitted to IVF/ICSI cycles, and how these variations influence response to COS     and pregnancy outcomes. Thus, this project has the aim to develop a pharmacogenetic algorithm     associating gene polymorphisms, the patient clinical information, and functional and hormonal     biomarker to: 1) predict the patient response to gonadotropin; 2) develop individualized     gonadotropin regimens; 3) improve the accuracy of determining appropriate dosages of     gonadotrophins; 4) improve efficacy and patient compliance to COS; and finally 5) reduce the     time-to-pregnancy.   "
10403|NCT03149770|"     The overall objective of this project is to determine if the intranasal administration of     naloxone during exercise will be a novel approach to preserve the counterregulatory response     to hypoglycemia experienced the next day in patients with type 1 diabetes. Exercise induced     autonomic failure contributes to the development of impaired awareness of hypoglycemia.     Treatments that blunt the consequences of exercise induced autonomic failure, such as     preserving the post-exercise counterregulatory response to hypoglycemia, may improve     awareness of hypoglycemia. Naloxone, an opioid antagonist, is an extremely promising agent.     In healthy volunteers, intravenous administration of naloxone during exercise preserved the     counterregulatory response to hypoglycemia the following day (1). In this study,     investigators will extend the clinical applicability by administering intranasal naloxone to     individuals with type 1 diabetes. Specifically, the investigators will use a randomized,     placebo controlled, crossover design to administer drug or placebo to patients with type 1     diabetes during acute exercise and assess the counterregulatory response to hypoglycemia the     following day. The use of intranasal naloxone is a highly innovative aspect of this proposal.     Intranasal naloxone translates readily to clinical use and, as demonstrated by the     investigators preliminary data, achieves similar plasma drug concentrations as after IV     administration.   "
10404|NCT03149757|"     YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted     version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the     RCT, intervention participants will have access to the full YouTHrive (YT) website- a     mobile-enhanced private social networking website aimed at improving medication adherence for     YLWH. The investigators will enroll up to 58 YLWH for formative work on YT, and 350 YLWH     (15-24 years old) of all genders with a detectable viral load (VL) across six cities and     randomize them to either the intervention condition or control condition. Assessments will be     collected at baseline, 5, 8, and 11-month follow-up.   "
10405|NCT03149744|"     This investigation is looking at a currently available technology to see if it could have     another use i.e. in helping to diagnose patients with sleep apnoea.      With 2-4% of the population suffering from this disease, and the current wait time for a test     at approximately 20 weeks, it is hoped that a simple screening method could help speed up the     process of finding these patients and getting them on treatment faster.      The current standard of care test involves a sleep study in the patients own home with a     device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless     and consists of one small, discrete unit attached to the patients side and a mobile device     plugged in by the bed.      Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to     participate. The RespiraSense Sleep Screener data is only for comparison purposes and will     have no effect on their clinical care.      If patients agree to participate they will undergo the sleep study with both devices in the     same night and may be followed up with over the phone on their experiences with the test.   "
10406|NCT03149731|"     Near-infrared spectroscopy (NIRS) functions in a manner similar to pulse oximetry, using the     difference in absorptive qualities of oxy- and deoxyhemoglobin to infrared light to quantify     the percent saturation. There is also available evidence shows that tissue oximetry is     sensitive and has a quicker response to physiological derangement, such as bradycardia, in     preterm newborns. Additionally, it is demonstrated that reduced postoperative cerebral tissue     oxygenation index variability in neonatal survivors of congenital heart disease surgery with     poor neurodevelopmental outcomes. The SafeBoosC phase II randomized clinical trial     hypothesizes that the burden of hypo- and hyperoxia can be reduced, and consequently the risk     of brain injury, by the combined use of close monitoring of the cerebral rStO2 and an     evidence-based treatment guideline to correct deviations in rStO2 outside a predefined target     range. In this study, we will monitor 2 different tissue beds including cerebral and     abdominal somatic tissue rStO2 and SpO2 in neonates. Further research is needed to     investigate clinical implications for using this measure to drive therapeutic interventions.   "
10407|NCT03149718|"     Opioid medication misuse and overdose have reached epidemic proportions in the US. Community     pharmacy is a potentially valuable resource for addressing opioid medication misuse. This     study will manualize and establish the feasibility, acceptability, and clinical effect of a     community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence,     eliminating misuse, connecting patients to additional care, and safeguarding against     overdose.   "
10408|NCT03149705|"     Ischemic stroke is the first cause of acquired disability of the adult, the second cause of     dementia and the third cause of death in the industrialized countries, what constitutes à     major public health issue. Stroke is characterized by a cerebral parenchymal lesion due to an     ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). For a long time, the     only approved treatment was the intravenous thrombolysis (rt-PA). Recently, thrombectomy has     proven its superiority in this pathology.      Cohorts of patients with stroke are rare but can be very valuable by their clinical,     laboratory and imaging well documented. They are the source of new hypotheses for research or     interventions as well as the quality of care assessment tool.      The main objective of this project is to identify new markers: biological and imaging,     treatment response and prognosis after ischemic stroke.      Secondary objectives of the HIBISCUS-STROKE cohort are to establish a clinical database,     completed by biological samples and by imaging data that can be used in the following areas:        -  Descriptive epidemiology of ischemic stroke and cerebral reperfusion,        -  Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of          treatment in real life, costs        -  Assessment of the long-term effect of the treatment on the occurrence of disability,          stroke recurrence and death,        -  Quality of life and personal, familial, professional and social consequences of stroke,        -  Research of new diagnostic and prognostic biomarkers,        -  Research projects.   "
10420|NCT03149549|"     The purpose of this first-in-human study of CX-2009 is to characterize the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009     in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM:     PRObody CLinical Assessment In Man CX-2009 clinical trial 001      PROBODY is a trademark of CytomX Therapeutics, Inc   "
10903|NCT03143205|"     This is a pilot study of a new 9-session individually delivered cognitive behavioral     intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men     will be recruited for the study then will be randomly assigned to either the new 9 session     intervention or a writing task condition.   "
10409|NCT03149692|"     One case of unsuccessful penile transplantation has been reported from China. The patient had     suffered an industrial machine accident and lost his penis to the level of the pubic skin.     Unfortunately the patient's wife insisted at about two weeks post-operatively that the organ     be removed. At the time of surgical removal the penis was viable, except for a degree of     superficial skin necrolysis. This has sparked debate on ethical issues regarding penile     transplantation. South Africa is uniquely positioned in Sub-Saharan Africa and worldwide with     relatively advanced medical services and a high prevalence of ritual circumcision practice     with reports of high morbidity and mortality in the last 20 years. The substantial number of     young men left with a severe penile defect or complete loss of the penis [9] creates a     possible place for penile allograft transplantation as a treatment option.   "
10410|NCT03149679|"     Single center, open labeled, phase 2 clinical trial, where patients with metastatic     colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second     week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be     included in the treatment arm.   "
10411|NCT03149666|"     Although taste influences food choices and favours diseases like obesity, there is no     consensus about the existence of correlations between bitterness and anthropometric     variables. Also, an electronic-based method for data collection could provide a more     appropriate way for the evaluation of taste perception and save time.      The objective is to search for correlations between bitterness and anthropometric variables.   "
10412|NCT03149653|"     The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or     SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was     added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion     cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events.     We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant     enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine     production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients.     The non-interventional group of healthy controls was included for comparison.   "
10413|NCT03149640|"     The objective of the study is to prove that after the third day of invasive mechanical     ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.      Parallel two group double blind randomized controlled clinical trial. Individual     randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on     centre in order to account for variations in VAP prevention bundle implementation and use of     systemic antibiotics the day of randomization. Patients will be treated three consecutive     days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive     care unit for the occurrence of VAP according to international guidelines until day 28.   "
10414|NCT03149627|"     The purpose of this study is to recruit a random and representative sample of individuals     within several Zambian communities for markers of Hepatitis B Virus (HBV) and to characterize     chronic HBV infection and indications for treatment.   "
10415|NCT03149614|"     The aim of this study is to compare the clinical effects of spinal mobilization versus     vertebral resonant oscillation (POLD) in patients with bilateral mechanical neck pain on pain     sensitivity and neck pain intensity.   "
10416|NCT03149601|"     Adults with obesity have an imbalance of bacteria in their intestines which may contribute to     weight gain and diseases related to obesity. Restoring the balance of these bacteria (the     microbiota) could help reduce weight and related diseases. However, little is known about     this imbalance in children with obesity. This research study will map out the compositions of     the gut microbiota of children and compare them with those of children who have healthy     weights and different degrees of obesity. This project will also measure the amounts of fatty     acids in the stools which are an indication of how efficiently the intestines absorb calories     from food. If an imbalance is detected in children with obesity, then this information can     help researchers test ways to restore the gut microbiota with hopes of reducing weight and     some of its related health problems.   "
10417|NCT03149588|"     Sevoflurane and propofol are the most popular drug choices for maintenance of general     anaesthesia for caesarean section. However, effects of these two anesthetics on maternal and     fetal outcomes after caesarean section haven't been compared directly. The aim of this study     is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia,     and to try to determine which anesthetic is better for maternal and fetal outcomes after     caesarean section.   "
10418|NCT03149575|"     This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with     glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if     appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide,     and bevacizumab and now has progressive disease during or after bevacizumab.      A total of up to 180 eligible patients with recurrent/progressive GBM or GS will be     randomized to receive either the investigational drug (VAL-083) or Investigator's choice of     salvage therapy as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients     will be randomized to receive VAL-083 at 40 mg/m2 IV on days 1, 2, and 3 of a 21-day     treatment-cycle, for up to 12, 21-day treatment cycles or until they fulfill one of the     criteria for study discontinuation. Up to 60 patients will be randomized to receive     Investigator's choice of salvage therapy, limited to temozolomide, lomustine, or     carboplatin, until they fulfill one of the criteria for study discontinuation. The dose level     for Investigator's choice salvage therapy (temozolomide, lomustine, or carboplatin), will be     in accordance with the product label or institutional guidelines.      In both study arms, interval medical histories, targeted physical exams, neurologic     evaluations, complete blood counts, and other laboratory and safety assessments will be     performed approximately every 21-days while receiving treatment. Tumor assessments are to be     performed approximately every 42 ± 7 days while remaining on study. The study is estimated to     last approximately 20 months.   "
10419|NCT03149562|"     Although lacking strong evidences, plasma transfusions are commonly used in critically ill     neonates. To date, the relationships between plasma transfusions and nosocomial infection     remain controversial and no study has reported the relationships between plasma transfusion     and invasive fungal infection (IFI)   "
10904|NCT03143192|"     The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP)     macular laser in combination with intravitreal aflibercept for the treatment of     centre-involved diabetic macular edema.   "
10422|NCT03149523|"     Over the last 10 years, technological advances in molecular biology enabled a more accurate     genomic characterization of tumors. For each tumor location, this led to the identification     of subgroups with similar molecular characteristics. This identification allowed the     development of targeted therapies and thus to improve the patient prognosis. This molecular     characterization has also revealed the tumor heterogeneity. It may be the cause of treatment     resistance and therefore of relapses. Additionally, tumor cells are in constant dialogue with     their microenvironment composed of different immune or non immune cells. This     microenvironment is now targeted in cancer treatment.      To date, there are few studies that combine a deep genomic characterization of both tumor and     tumor microenvironment of the patient. Combining the two types of studies on the same tumor     should help to define new therapeutic targets and should allow a combination of targeted and     immunomodulatory therapies. To this end, our project is to conduct an exhaustive integrated     exploratory analysis at genomic, transcriptomic and immunological levels of 3 tumor types (in     colon, kidney and liver cancer).   "
10423|NCT03149510|"     In the United States, about 40 percent of heart failure (HF) patients are readmitted within     1-year following their first admission for HF and hospitalization accounts for approximately     70 percent of the costs of HF management. As a result, the management of HF patients is     evolving from the traditional model of face-to-face follow-up visits toward a proactive     real-time technological model of assisting patients with monitoring and self-management while     in the community. The investigators plan to test the impact of a mobile application on     clinical outcomes in HF.   "
10424|NCT03149497|"     Classic management of cervical spine sublaxation and dislocation is combined anterior and     posterior approach. Unfortunately there are disadvantages for this approach like: increasing     morbidity related to each approach, increasing surgical costs, increasing operative time as     well as the risk of blood loss.      Anterior approach has the advantages of supine position, less surgical trauma and direct     anterior decompression of neural elements. Disadvantages include less mechanical stability     and postoperative dysphagia.   "
10425|NCT03149484|"     The purpose of this research study is to learn about the hearing outcomes of children with     conductive hearing loss who are treated with bone conductive devices and their outcomes with     remote microphone technology.   "
10426|NCT03149471|"     The aim of this study is to investigate the association between endothelial dysfunction,     measured by RHI as assessed by the peripheral arterial tonometry method, and PE complications     defined as re-event of PE or DVT, systemic embolism or all-cause mortality   "
10427|NCT03149458|"     The majority of hemiparetic patients have balance disorders, which impact independence in     daily living activities and walking. Conventional techniques used in rehabilitation improve     balance but have shown no effects on dynamic balance required during walking. Recently dance     is proposed to improve dynamic balance in older people and people with Parkinson's disease.     Although many studies showed that dance is an effective activity to improve balance in these     people, it has never been assessed in hemiparetic patients (except a case report). The aim of     this study is to show that a dance program improves the balance of hemiparetic patients,     compared to a control group. This randomized controlled study aims to include 40 hemiparetic     patients who will perform a dance program (experimental group) or a upper-limb rehabilitation     program (control group) for 8 one-hour sessions.   "
10428|NCT03149445|"     Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.   "
10429|NCT03149432|"     The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for     patients with amputation after vascular etiology. the secondary aim are to measure the impact     of the mirror therapy on quality of life, sleep disorders, and predictive factors for     effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric.     There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine     + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the     inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be     the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include     40 patients. The length of the study is 20 months.   "
10430|NCT03149419|"     Hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with     cardiovascular disease and endothelial dysfunction. Estrogen therapy, associated or not with     progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial     function of postmenopausal women with hot flushes, even those with cardiovascular risk     factors, such as hypertension. It is not known whether hot flushes are a cause for the     development of endothelial dysfunction or are markers of this dysfunction, evidenced by     estrogen deficiency, thus representing primitive target organ (vessel) lesion. Paroxetine was     approved by the FDA as a non hormonal treatment for menopausal hot flashes. In this     double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5     mg / day, compared to placebo, during 12 weeks are evaluated.   "
10440|NCT03149289|"     Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the     severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection.     Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver     complications. EASL and AASLD guidelines recommend interferon-free regimens for the treatment     of HCV infection in patients with hemoglobinopathies. However, data regarding the use of     direct-acting antiviral drugs (DAAs) in this patient population are very few This large,     observational study evaluated the safety and efficacy of standard therapy with DAAs in a     large Italian cohort of with hemoglobinopathies, chronic HCV infection and advanced liver     fibrosis.   "
18412|NCT03044548|"     This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to     improve health outcomes and quality of care of children with malnutrition   "
10696|NCT03145896|"     Crohn's disease (CD) and ulcerative colitis (UC) are chronic gastrointestinal diseases     characterized by relapsing and remitting inflammation of the intestines Anemia may often     complicate the course of inflammatory bowel disease (IBD). The cause of anemia in IBD is     multifactorial In the chronically ill patients, it has been described that the mechanism     underlying anemia involves hepcidin.A potential mechanism underlying anemia during an chronic     disease is suggested by recent data demonstrating a hepcidin lowering effect of vitamin D   "
10431|NCT03149406|"     Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the     most important causes of morbidity and mortality in the Western world. The constitution of     the atheroma plaque is linked to the deregulation of several biological phenomena, including     angiogenesis, adipogenesis, inflammatory response, lipid metabolism and oxidative stress. In     addition to its anatomical and physiological characteristics, the notion of plate stability     is of paramount importance for clinical implications. This stability depends largely on the     biological composition of the plate. A vulnerable or unstable plaque often has a large lipid     body consisting of foam cells (macrophages laden with oxidized LDL) with a thin fibrous     screed consisting of smooth muscle cells (CML), collagen fibers and extracellular matrix.     This plaque is also made up of numerous inflammatory cells including macrophages, rich     vascularization and intraplate hemorrhage. Although the cell composition of the unstable     plate is still relatively established, its molecular analysis remains little known.      The benefit of carotid surgery in asymptomatic patients with stenosis greater than 70% is     increasingly controversial given the moderate risk of spontaneous stroke under optimal     medical treatment. This annual average risk is less than 5%. Thus, the discovery of an     original and innovative biomarker, predictive of plate rupture, would define the patients     most at risk, who benefit most from this surgery.   "
10432|NCT03149393|"     This study is a randomized, double blind, double dummy, multicenter, parallel controlled     clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi     Weitong granules in the treatment of functional dyspepsia.   "
10433|NCT03149380|"     To evaluate the effectiveness of an online educational course on Alzheimer's disease (AD)     prevention, treatment and caregiving.   "
10434|NCT03149367|"     Comparison of the results of levator resection operation with the use of fixed sutures     technique in which the levator muscle is approached through skin incision and the muscle     shortened and sutured directly to the tarsus then the skin crease reformed with interrupted     sutures which pick up the underlying levator muscle versus the results with the use of     adjustable sutures in which the suture passes through the levator muscle into the tarsal     plate and out through the skin edge .the skin crease is formed separately so that adjusting     the suture doesn't open the wound, the suture can be adjusted according to the result up to 4     days post operative.   "
10435|NCT03149354|"     Since the appearance of high-efficiency anti-retrovirals (HAARTs) in the treatment of Human     Immunodeficiency Virus (HIV), several studies have shown an increase in the prevalence of     hypothyroidism (frank, rough or low hypothyroidism T4) in cohorts of HIV-infected adults and     children. More specifically, rough hypothyroidism (increased TSH and normal thyroid     peripheral hormones) have a prevalence of about 3-12% in HIV-treated patients, which is     higher than the general population of about 4.3%. The etiology of frustrated hypothyroidism     remains debated in the literature; Effects of antiretroviral therapy (ARV) such as     Stavudine®, the effect of dyslipidemia, the effect of HIV infection itself, in proportion to     severity (expressed as low CD4 cell count) and AIDS stage. Thyroid dysfunction does not     appear to be of autoimmune origin, as anti-peroxidase antibodies are rarely present in     HIV-infected patients, unlike the general population.      With the increased life expectancy of HIV-infected patients and the indications of different     experts to be treated earlier, the duration of exposure to ARVs is also increasing.     Therefore, their chronic toxicity deserves particular attention, in particular on thyroid     function and / or thyroid hormone metabolism, since iatrogenicity has not been completely     ruled out. In addition, clinical evidence suggests that dysthyroids may be corrected or     worsened over time in HIV patients (unpublished personal data).      Today, the natural history of frustrated hypothyroidism and its consequences are not reported     in patients infected with HIV. However, it is recognized in the elderly, fructified     hypothyroidism evolves over time towards frank hypothyroidism; The latter is associated with     an increased prevalence of dyslipidemia, atherosclerosis, diastolic hypertension and     therefore an increased risk of myocardial infarction.      It therefore seems interesting to review the evolution of thyroid function in HIV-infected     patients, with sufficient follow-up.   "
10436|NCT03149341|"     The purpose of this study is to (1) quantify cardiovascular anatomy and physiology using     magnetic resonance imaging under both resting and exercise conditions in patients who have     congenital heart disease and in age-matched normal volunteers, (2) use computer models to     reproduce and simulate blood flow in these patients, and then (3) to combine the imaging data     and computer models to estimate values which cannot be directly measured and to predict     physiological changes induced by exercise and medical or surgical therapies.   "
10437|NCT03149328|"     People living with end-stage kidney disease (ESKD) need dialysis or transplantation in order     to stay alive. This illness and treatment significantly impact peoples' health, emotions,     work and relationships. To promote person-centred care, healthcare professionals should be     asking patients about what matters to them and using this feedback to plan and deliver care.     Patient-reported outcome and experience questionnaires (jointly referred to as PROs) allow     patients to provide information about their quality of life, symptoms and experiences with     care. PROs are increasingly used to help healthcare professionals learn about what is     important to patients and the impacts of illness or treatments from patients' point of view.     Embedding feedback from patients into routine clinical practice is important in end-stage     kidney disease because of the physical and quality of life challenges these patients face     when living with kidney failure.      PROs provide vital and often missing information that the healthcare team can use to support     patients. However, PROs administered via paper questionnaires have been perceived as     cumbersome, difficult to integrate with other health information and do not provide immediate     feedback.      In this research, home dialysis patients will have the opportunity to complete electronically     administered PROs (ePROs) and healthcare professionals will receive education about how to     use PRO information. The goal is to learn how to support healthcare professionals to     routinely use this information to inform patient care, and see if this makes a difference in     patients' symptoms, person-centred care, quality of life and satisfaction with care.      Learning what matters most to patients is essential for healthcare professionals to provide     person-centred care. This research will address the gap in our understanding of how to best     use patients' reports in healthcare. Findings of this research may ultimately improve the     quality of healthcare for Canadians living with end-stage kidney disease.   "
10438|NCT03149315|"     This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced     anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA     approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL),     and Waldenstrom's macroglobulineia (WM). We propose to administer this approved drug to     adults with food allergy to inhibit food allergy responses.   "
10439|NCT03149302|"     The sensorimotor disturbance and postural instability have been demonstrated to be associated     with neck pain. Specific therapeutic exercise and manual therapy for the cervical spine are     effective interventions for improving dizziness symptoms, neck impairments, functional     ability and quality of life. However, the effects of these interventions on the actual     impairment of joint position sense and balance remain uncertain. Adaptive changes in the     sensorimotor and postural control systems may need to be specifically addressed.   "
10462|NCT03149003|"     This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2     study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with     recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line     therapy consisting of surgery and radiation with or without chemotherapy.   "
26738|NCT02935725|"     A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the     pharmacoMRI Effects of AUT00206 in Healthy Male Participants   "
10441|NCT03149276|"     A systematic literature review from March through June 2014 supports the premise that limited     English proficiency (LEP) persons face barriers and disparities to medical care that     English-speaking persons do not face. Language barriers have a negative impact on health and     health care, including lower health status, lower likelihood of having a primary care     provider, lower rate of preventative care, higher use rate of diagnostic tests, higher rate     of severe psychopathology diagnoses, and higher risk of drug complications . Additionally,     LEP persons experience problems with effective communication with providers, inappropriate     diagnoses and treatments, lower comprehension of medication instructions and adherence to     regimens, fewer follow up visits, low quality care, poorer health outcomes, and low patient     satisfaction.      Research has proven a relationship between LEP and health care outcomes, specifically a     relationship between positive outcomes and use of professional interpreters. Not sharing a     common language creates a barrier to providing safe, effective, client-centered Occupational     Therapy (OT) and knowledge of outcome satisfaction for this population. Using trained     interpreters would reduce the barriers created by language discordance.      This evidence-based project intends to measures the influence of interpreter service on LEP     patients' perceived quality of care using a satisfaction survey. Gathered data will be used     to consider development and implementation of practice guidelines for use of professional     interpreter services for LEP patients receiving OT services at Midwest Orthopaedics at Rush.     Development and implementation of practice guidelines that include use of trained     interpreters when providing OT services to LEP patients will facilitate a client-centered     approach and improve quality of care for this population.      The project is also being implemented as part of a degree requirement for the Doctorate of     Occupational Therapy Program at Chatham University.   "
10442|NCT03149263|"     In children requiring botulinum toxin injections, improving supervisory procedures of     injection sessions to reduce pain and improve the experience of this invasive procedure is     needed. The intervention of medical clowns seems very interesting in this goal, but its     effectiveness has not been proven within the botulinum toxin injections. The objective of the     study is to evaluate in terms of profit the presence or absence of clowns during a session of     botulinum toxins by determining their impact on pain and anxiety felt among children and     their carers   "
10443|NCT03149250|"     The study aims to investigate the impact of preeclampsia on hemostasis.   "
10444|NCT03149237|"     The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms     of behavior change, and cost-effectiveness of a partners-focused integrated elimination of     mother-to-child transmission of HIV (EMTCT) package comprised of: 1) antenatal care-based     couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2)     Couples-based treatment in the post-partum period; (3) Couple-based education and skills     building; and (4) Treatment continuity with the support of expert-patient (peer) supporters     from couples who have successfully navigated EMTCT. This innovative approach to scaling up     EMTCT services, if proven feasible and effective, will be adopted in President's Emergency     Plan for AIDS Relief (PEPFAR) programs to accelerate progress toward EMTCT and helping     families with HIV infection live long, healthy lives.   "
10445|NCT03149224|"     The purpose of this study is to characterize specific brain signals elicited by motor     disturbances and errors in stroke patients. The patients will perform a motor task using both     their affected and unaffected hands. There are two types of errors: low level errors and high     level errors. While disturbances (low level errors) have been shown to elicit P300,     uncorrectable actions (high level errors) have been shown to elicit ERN. These event related     potentials (ERP) have been extensively studied in healthy subjects including a recent paper     from our Lab.   "
10446|NCT03149211|"     The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of     UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing     antiretroviral treatment interruption.   "
10447|NCT03149198|"     Introduction: Physical exercises have been recommended to improve overall well-being in     patients with fibromyalgia, with the main goal of repairing the effects of lack of physical     conditioning, and improving symptoms especially pain and fatigue. Very well estimated and     widely known are the studies that support the use of the pilates method as effective in     improving the symptoms of the disease.      Objective: To evaluate the effectiveness of the soil method in improving pain in women with     fibromyalgia in the city of Santa Cruz, RN.      Methodology: This is a randomized controlled trial with blind evaluator, where 60 patients     with fibromyalgia diagnosis are divided into two groups. The intervention group, perform an     exercise program based on the pilates method in soil and another, considered control group,     participate in a program of aerobic exercises in the pool. Both groups conduct supervised     exercise programs 2 times a week for a period of 12 weeks. The evaluation instruments used in     an EVA (visual pain scale); FIQ Questionnaire - Fibromyalgia Impact Questionnaire; Functional     ability by the Timed Up and Go test and 6-minute walk test; A quality of sleep by the     Pittsburgh Sleep Quality Index (PSQI-BR) and an ESS-BR (Epworth Sleepiness Scale); Finally, a     general quality of life for the SF-36.      Statistical analysis: Data are analyzed by t-student, Mann-Whitney test, repeated-measures     ANOVA and intention-to-treat analysis.   "
10448|NCT03149185|"     The purpose of this study is to examine the effects of various factors such as emotions,     stress, stress management techniques (for example relaxation and coping techniques), and     health information on quality of life, distress, depression, coping, and physical health in     men diagnosed with advanced prostate cancer. We also evaluate the effectiveness of a 10-week     group-based internet delivered psychosocial intervention. Primary outcomes are symptom burden     (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical & social     functioning).      Participation in this study includes three face-to-face assessments: baseline (at the     beginning of the research study), 6-month follow-up, and 12-month follow-up. The 6- and     12-month follow-up interviews are conducted after the participant has completed the 10-week     group intervention. Participants are randomized into either an intervention group (targets     stress management skills - relaxation, coping) or a control group (health information and     health promotion strategies - benefits of proper nutrition and treatment compliance). Both     groups meet for 10 consecutive weeks through an internet video conferencing platform.      At the baseline, 6- and 12-month follow-ups, we collect blood and saliva samples. The blood     samples go through a three-day process in which we extract and store serum, plasma, and cells     for further analysis and gather proliferation data. We use the saliva to measure the cortisol     diurnal rhythm.   "
10643|NCT03146754|"     This is an exploratory study to evaluate lung ultrasound as a method for measuring     extravascular lung water in stabilized patients during hospitalization for ADHF. Subjects who     have been stabilized following admission for ADHF and capable of lying supine will be     evaluated by lung ultrasound to determine the degree of lung congestion as measured by the     total B-line score. Since different patients may require different degrees of postural change     and/or other maneuvers (e.g., leg elevation or exercise) to induce B-line increments, a     tailored sequential protocol will be employed to define which maneuvers are sufficient for     each patient.   "
10449|NCT03149172|"     The purpose of this pilot study is to conduct a interventional prospective clinical trial to     evaluate the efficacy of three different xenografts for ridge preservation by comparing the     quality of newly formed bone using histomorphometric and micro CT analysis.The three     xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix®     (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective     studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and     Equimatrix®, when placed in extraction sockets.      Participants will be recruited from patients in the TUSDM clinics that require extraction of     single rooted non-molar tooth and are treatment planned to receive dental implants in the     future. Participants will be randomized to receive one of the three xenograft materials after     tooth extraction. The percentage of newly formed bone and bone density will be compared     between the three materials 4-6 months after ridge preservation.   "
10450|NCT03149159|"     The purpose of this study is to see if continued nivolumab with the addition of ipilimumab     plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or     complete responses in patients with metastatic ccRCC who fail initial treatment with single     agent nivolumab.   "
10451|NCT03149146|"     This study aims to improve the Clinical Decision Making (CDM) skills of a group of Myanmar     physical therapists by series of educational workshops that will introduce them to and guide     them through the decision making process by using the CDM workbook. Participants will be     separated into two groups, CDM workshop group and CDM workbook group. There will be three     time assessments; one pre-workshop/ workbook and two post-workshop/workbook assessments by     using Clinical Decision Making (CDM) assessment worksheet.   "
10452|NCT03149133|"     Occlusive or ischemic training is a type of strength training which is becoming more and more     popular every day. The safety, efficacy and detailed description about the use of occlusive     training is well documented in the literature. However, the effects on hypertrophy and the     stiffness of the muscle tissue are not studied. We aimed to measure these changes by     ultrasound technology in a randomized controlled design.   "
10453|NCT03149120|"     This trial will assess whether nivolumab alone or nivolumab combined with pazopanib will be     associated with an improvement in progression free survival (PFS) at 6 months   "
10454|NCT03149107|"     Schizophrenia is a severe mental disorder associated with significant impairments in     affective, cognitive and social functioning. Consequently, a special interest in the     prevention of schizophrenia and psychotic disorders has emerged. Pharmacological as well as     psychological interventions show promising preventive effects. The purpose of this     multicentric study is the investigation of possible preventive effects of a treatment     combination containing a psychotherapy form and medication (N-Acetylcytein - NAC) in     individuals with an enhanced risk for developing schizophrenia. Both treatment forms may     reduce the risk in this population due to their specific properties: The psychotherapy can     improve social skills, whereas NAC is supposed to develop its protective effects on neuronal     level due to its antiinflammatory properties. We will investigate the preventive effects by     measuring transition rates to psychosis after treatment as well as improvements in social,     affective and cognitive functioning.   "
10455|NCT03149094|"     The purpose of this study is to create a smartphone, tablet and web-based application to help     people deal with stress. Stress often increases fatigue in people with HIV infection, so     successfully dealing with stress could help reduce HIV-related fatigue. The study is being     done at one site, the Medical University of South Carolina. Approximately 20 people will take     part in this portion of the study.   "
10456|NCT03149081|"     The purpose of this study is to determine whether oral administration of Boswellia causes     biological changes in primary tumors of breast cancer and colon cancer patients.   "
10457|NCT03149068|"     Inflammation begins during early stages of CKD in which neutrophil counts are increased,     whereas lymphocyte counts are decreased during inflammation. In addition to known     conventional indications of inflammation such as C-reactive protein (CRP), fibrinogen,     erythrocyte sedimentation rate, several interleukins and tumor necrotizing factor alpha,     Neutrophil-to-lymphocyte ratio (NLR) has increasingly been reported as a measure of systemic     inflammation (Okyay G U et al 2013 and Yilmaz G et al ,2017) Several recent studies have     shown that mean platelet volume (MPV) is also increased during inflammation and may be     associated with poorer prognosis in CKD (Yilmaz G et al ,2017).   "
10458|NCT03149055|"     The purpose of this study is to study the effects of isavuconazole in preventing fungal     infections in patients who have had a hematopoietic stem cell transplant (HCT).   "
10459|NCT03149042|"     Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT     estimation can aid in the severity estimation of significant atherosclerotic lesions.     Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be     validated in large multi-center clinical trials. Using patient specific 3D printed coronary     phantoms would allow optimization of FFR-CT algorithms with a measured validation technique     without the need for large clinical trials. Thus we believe that this study will result in a     FFR-CT algorithm/method with a better predictability for arterial lesion severity than those     existing on the market today. Flow measurements will be compared with: CT-FFR for both     patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical     study will include ~50 patients over a year and half at GVI.   "
10460|NCT03149029|"     This research study is studying a combination of drugs as a possible treatment for     unresectable or metastatic melanoma.      The drugs involved in this study are:        -  Pembrolizumab (Keytruda)        -  Trametinib (Mekinist)        -  Dabrafenib (Tafinlar)   "
10644|NCT03146741|"     This study is being conducted to determine safety and effectiveness of transplanting hearts     from Hepatitis C-positive donors into Hepatitis C-negative patients on the heart transplant     waitlist, who will then be treated with Zepatier after transplantation.   "
10697|NCT03145883|"     This pilot study will use an unmasked, parallel group, randomized design. Thirty adult     overweight or obese subjects with mild-moderate persistent asthma will be randomly assigned     to one of two groups: 12-weeks of home-based moderate intensity aerobic exercise versus no     intervention. The study will include 2 clinic visits and 12 telephone calls. Exercise testing     to assess physical fitness levels will occur during visits 1 and 2. Blood sampling for     biomarkers, inflammatory markers, and other assessments will be done.   "
10463|NCT03148990|"     Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences     demonstrate the benefit for providing the universal access to vaccines containing measles and     rubella antigens, mainly due to, respectively, mortality in children and malformations in     fetuses. This is a Phase I-III, Controlled, randomized and double blind for the evaluation     double viral vaccine anti-measles and rubella (MR), which is developed and produced at     Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in     human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and     monitored for local and systemic adverse events and titration of antibodies. The study will     last 11 months in total.   "
10464|NCT03148977|"     The objective of this study is to determine whether our chemical assay can be used to     reliably predict graft take or failure in patients undergoing autologous skin grafting for     treatment of acute burn injury.   "
10465|NCT03148964|"     Open, prospective, multicenter French cohort study enrolling subjects aged of 15 years or     more, during or immediately after HIV-1 primary infection. This cohort was organized from the     outset to be highly multidisciplinary, bringing together immunologists, virologists,     clinicians and epidemiologists.   "
10466|NCT03148951|"     In the planned study the investigators want to evaluate the relation between postoperative     Visual Analogue Scale(VAS) scores, complications and minor/ major morbidities, mortality and     Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio.   "
10467|NCT03148938|"     Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad     diversity of symptoms and fluctuating progression patterns. Clinical assessments are     challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care     depends on early detection of disease progression. The Digital self-Assessment for Multiple     sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and     clinically validated remote monitoring platform for MS patients and clinicians. The     correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis     Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30     subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test     had a poor reproducibility and clinicians expressed the wish to measure a walking range     rather than a walking speed. Even though vision is the main sense impacting all other tests,     particularly when interacting with a mobile, visual tests are rarely performed in real life.     A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan     Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a     walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of     the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).      The hypothesis is that systematic and prospective multi-dimensional data collection of MS     disabilities through the DAMS mobile application will refine the quality and accuracy of both     clinicians and patients' knowledge of the disease progression and will ultimately improve the     current care of patients.      To test this assumption, the statistician will analyze:        1. The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests)          the low contrast vision test versus standard MS scales        2. The test-retest reliability of DAMS' scores at a 15 day interval   "
10468|NCT03148925|"     The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070.     Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers.     The resulting safety profile and anti-nicotine antibody levels will be evaluated.   "
10469|NCT03148912|"     Multicentre (Ottawa and Halifax) prospective cohort study using a diagnostic approach in     patients clinically suspected to have HIT that combines pretest probability assessment with     quantitative interpretation of anti-PF4 assay.   "
10470|NCT03148899|"     In human volunteers intranasal administration of oxytocin significantly increases     parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease     with high cardiovascular risk factors, yet this disease remains very poorly treated.      This proposal, based on the current literature and new basic science results detailed above     on the role of oxytocin in cardiovascular control, will test if oxytocin administration     improves adverse cardiovascular events during the recurrent nocturnal apneas in patients with     OSA. This project will lay the groundwork and provide preliminary data to obtain NIH funding     to test this important hypotheses more thoroughly and in larger clinical trials.      This study will explore if intranasal oxytocin has any positive cardiovascular benefits in     patients with sleep apnea.   "
10471|NCT03148886|"     About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer     become secondarily metastatic.Thanks to recent therapeutic advances, the median survival     ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from     many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The     physical, biological, psychological and clinical benefits of physical activity (PA) during     treatment in patients with localized breast cancer have been widely demonstrated. Numerous     studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge,     only four interventional studies worldwide focused on the implementation of PA in patients     with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA     intervention with patients with metastatic breast cancer to see if the observed effects in     localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study     is an interventional cohort designed to assess the feasibility of a 6-month adapted physical     activity intervention, performed under real life conditions in patients with metastatic     breast cancer.   "
10472|NCT03148873|"     Your respiratory rate is your number of breaths per minute. The standard way for this to be     measured is by a nurse looking at you for one minute and manually counting your breaths over     this time. They normally do this once every few hours. At times, it can be useful to have     your respiratory rate continuously monitored. A device that can do this is a capnograph. For     the patient, this involves wearing a tube in their nose and around their ears while trying to     minimise their movement and talking so the measurements can be taken.      This research study is looking at a new respiratory rate monitor and comparing how well it     works against the current accepted methods.      Patients who are admitted to the Acute Medical Unit will be invited to participate should     they meet all eligibility criteria.      Subjects will be monitored for two hours:      (i) For the first hour subjects will wear a capnograph, RespiraSense and have their     respiratory rate manually counted by a research nurse. During this time the subject will be     asked to keep talking and moving to a minimum.      (ii) For the second hour subjects will wear RespiraSense and have their respiratory rate     manually counted by a research nurse. During this time the subject can talk and move as they     wish.   "
10917|NCT03143010|"     Small doses of dexmedetomidine1.5,3, 5µg used in combination with bupivacaine, in humans for     spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer     duration of motor and sensory block with preserved hemodynamic stability and lack of     sedation.   "
10473|NCT03148860|"     Methotrexate (MTX) co-medication can improve the therapeutic effect of biological therapies     (e.g. Tumor necrosis factor (TNF) -inhibitors) in rheumatoid arthritis (RA), but its role in     Psoriatic Arthritis (PsA) remains unclear.      No data from Randomized Clinical Trials (RCTs) are available to address the questions whether     add-on of MTX to UST monotherapy, or a withdrawal of continuous MTX therapy in patients with     newly initiated Ustekinumab (UST) treatment or simultaneously induction of MTX with UST in     naive active PsA-patients will influence outcome measurements.      So, the purpose of the study is to analyse the effects of blinded MTX-co-medication on     outcome in patients treated with UST: Non-inferiority at week 24 of UST monotherapy compared     to add-on to MTX in patients with active PsA and at least 12 weeks of MTX treatment prior to     screening or who are actually not treated with MTX and do not have prior inadequate response     to MTX-treatment for PsA will be demonstrated.   "
10474|NCT03148847|"     The prevalence of heart failure is estimated to 2.3 percent of the adult population and     strongly increases with age, according to french disability-health surveys. In France, more     than 32,000 annual deaths are attributable to heart failure and the five-year survival rate     is similar to those found in many cancers. A better therapeutic management (angiotensin     converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of     heart failure requiring hospitalization, but, nevertheless it remains high.      The severity of cardiogenic pulmonary edema depends on several factors such as etiology,     hemodynamic status, effect on hematosis, and fatigue.      It is important to note that cardiogenic pulmonary edema initial management is decisive. In     addition, early and adapted management of cardiogenic pulmonary edema is associated with a     shorter hospital stay and reduced hospital mortality.      The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network     (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute     Savoie. Its main goal is to help improve emergency management by using regional good practice     guidelines (www.renau.org). In this context, projects aiming to evaluate professional     practices are developed regularly. Since emergency management of cardiogenic pulmonary edema     has not been evaluated, the Northern French Alps Emergency Network offers an approach to     improve professional practices by defining and disseminating guidelines on cardiogenic     pulmonary edema management which will then be assessed.   "
10475|NCT03148834|"     Reperfusion therapy in acute myocardial infarction saves viable myocardium, but paradoxically     reestablishment of coronary artery flow also induces damage and cell death, decreasing the     full benefit of reperfusion in terms of reduction of infarct size and preservation of     ventricular function . Myocardial reperfusion can in itself produce more damage and cell     death, this process defines the phenomenon of reperfusion injury, which could be prevented by     applying additional therapies.   "
10476|NCT03148821|"     Participants in the study will be adults with full mobility, with the capacity to give     informed written consent. The investigators will recruit a group of volunteers in order to     represent a variety of BMIs, in an attempt to gain a sample of the BMIs found in the     population. The investigators will mimic current practices and standard equipment in order to     replicate real conditions as closely as possible.      Participants will lay on the following surfaces in the following scenarios        1. Ambulance scoop: supine (lying flat on their back)        2. A&E trolley: supine        3. Hospital bed: supine        4. Theatre table: supine        5. Theatre table: Left lateral (lying on their left side at 90 degrees to the operating          table) with pelvic binders (pads designed to keep the hip immobile).      Each participant will remain in each position on that particular surface for a period of 25     minutes. A pressure mapping mattress will lie between the participant and the surface     assessed to generate a pressure map.      Following completion of data collection, data will be analysed and any areas of potential     pressure damage vulnerability will be identified.   "
10477|NCT03148808|"     The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute     luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal     arteries with reference vessel diameters between 3.5 and 7.0 mm and lesion lengths between 36     and 96mm. The system is intended for use in patients with de novo lesions in the superficial     femoral and proximal popliteal arteries.   "
10478|NCT03148795|"     The purpose of this international, phase 2, open-label, 2-arm, response rate study of     talazoparib is to assess the efficacy and safety of talazoparib in men with metastatic     castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy     and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone     acetate/prednisone).   "
10479|NCT03148782|"     Organizational, time management and planning (OTMP) skills deficits are seriously impairing     features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD)     and autism, which compromise school performance and family relations. The manualized     Organizational Skills Training program (OST) was designed to target children's specific OTMP     deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The     current study combines a training intervention with non-invasive MRI imaging in a     pre-/post-design to address this question.   "
10480|NCT03148769|"     Bacteremia      The Hypothesis of the study are the followings:        -  To demonstrate relevant epidemiologic and clinical changes with potentially impact in          the management and prognosis of the patients with bacteremia.        -  Since the diagnosis and management is heterogeneous between centers, we could identify a          scenario to improve.        -  To identify quality indicators in the management of bacteremia.        -  To demonstrate that some interventions made by Bacteremia Team pose relevant impact in          the prognosis of bacteremia.   "
10481|NCT03148756|"     This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the     completion of therapy in patients with complicated bacteremia or infective endocarditis.   "
10482|NCT03148743|"     With the stem cell transplanting increasing, patients which effected with gut GVHD were also     increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD     were recruited.   "
10918|NCT03142997|"     This is an observational study to compare the effect of spontaneous ventilation versus     controlled ventilation on lung atelectasis using lung score measured by lung ultrasound. the     study will be conducted in children hospital of Cairo University Hospitals and study     population will be : children aged from one to eight years of age. primary outcome will be     the lung score measured by lung ultrasound.   "
10483|NCT03148730|"     This study will be the first study to report the combined use of three independent     closed-loop systems together to assist clinicians in titrating anesthesia, analgesia, fluid     and optimize ventilation in frailty old patients undergoing moderate to high risk surgery.     The potential benefits of optimizing the control of these variables by advanced closed loop     systems are two-fold. Firstly, this will likely decrease the variance of delivered care and     reduce deviation from the established standards, resulting in improved post operative     cognitive outcomes in elderly patients. Secondly, this would establish a precedent that     automated intraoperative systems have strong clinical significance and are more than     complicated toys, which is unfortunately how they are perceived now.      Hypothesis: Automated control of anesthetic depth (minimal episodes of overly deep or light     anesthesia) and hemodynamics (via improved volume administration) can decrease the occurrence     of postoperative cognitive dysfunction in elderly patients undergoing moderate to high risk     surgery (Better MOCA test in the postoperative period compared to the manual group [+ two     points in average])   "
10484|NCT03148717|"     This prospective double-blind placebo-controlled randomized clinical trial will be conducted     at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women,     candidates for cesarean section, will receive preoperative rectal 400 microgram of     misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of     misoprostol.      2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual     400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400     microgram of misoprostol.   "
10485|NCT03148704|"     Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in     the real world using.   "
10486|NCT03148691|"     The primary objective of this study is to evaluate the safety and effectiveness of 2     concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK)     Target Lesions on the trunk, extremities and face.   "
10487|NCT03148678|"     The overall goal of the outlined study is to scrutinize and to promote mindfulness via new     technologies using a combination of smartphone-based assessment and micro-interventions, fMRI     and real-time fMRI-neurofeedback.   "
10488|NCT03148665|"     The purpose of this study is to test the ability of OncAlert™ to screen for cancer and the     reappearance of cancer. OncAlert™ was developed by Vigilant Biosciences, a collaborator in     this research study. OncAlert™ is an oral rinse which is spit into a cup and sent to a     laboratory for analysis. OncAlert™ is considered experimental by the FDA because it is not     approved for the screening of cancer.   "
10489|NCT03148652|"     Cigarette smoking is a leading cause of morbidity and mortality in the United States. Among     individuals who engage in smoking cessation treatment, attrition rates remain high. Many     smokers experience difficulties in regulating their emotions, which reduces their ability to     benefit from standard interventions and leads to increased smoking behaviors. In addition,     cognitive deficits (e.g., reduced working memory capacity) may prevent smokers from applying     information from interventions, making smart choices about the benefits and risks of smoking,     and resisting smoking advertisements.      This study will test whether adding a working memory training and motivational enhancement     component to a standard, evidence-based cognitive behavioral therapy-based smoking cessation     program (SCP) can improve treatment adherence and successful quit rates. This study will     compare 5 sessions of SCP with an additional wellness-focused component (control     intervention) to SCP incorporating motivational enhancement and working memory training     (enhanced intervention). Participants will be adult smokers recruited from the greater     Boston community who are interested in quitting smoking. This study will determine the     efficacy, acceptability, and feasibility of the enhanced intervention.   "
10490|NCT03148639|"     Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the     patient and the therapist. For the therapist, one of the main difficulties arises from the     impossibility of directly communicating with the entity persecuting the patient. For the     patient, the therapeutic process is challenging because it aims at getting to better cope     with an entity that keeps repeating stereotyped and abusive sentences without having the     emotional strength to reply to the persecutor. To help overcome these clinical challenges,     virtual reality enable patients to recreate the face and the voice of their persecutor.The     hypothesis is that the engagement of patients in a dialogue with an external representation     of their persecutor, with the support of the therapist, would help them to gain better     control over their voices.   "
10491|NCT03148626|"     A triad of exhaustion, depersonalization and inefficacy, physician burnout is an epidemic     among trainees associated with delivering poor quality care. Training programs are desperate     for evidence-based programs that can prevent burnout during residency. Mindfulness training     programs can reduce burnout among primary care physicians, but have not been tested during     physician training. Pilot testing of a novel mindfulness curriculum during pediatric     internship was found to be feasible to implement.      The primary objective of this study is to determine if implementing a novel 6-month     mindfulness curriculum comprised of seven 1-hour sessions can reduce physician burnout and     increase mindfulness practice and empathy. A multicenter cluster randomized controlled trial     will be conducted among interns training in programs of various sizes and regions to address     this objective. The investigators hypothesize that completing a mindfulness curriculum during     internship will reduce interns' levels of physician burnout and increase their mindfulness     practice and empathy.      Within pairs in pediatric residency programs matched on size (a proxy for burnout), clusters     of interns in each program will be randomized to experience either the mindfulness curriculum     over a 6-month period (intervention) or receive the usual educational curriculum (control).     During a 15-month study period, burnout, mindfulness and empathy will be assessed using     validated measures at baseline, 6- and 15-month follow-up. The impact of the intervention     will be determined by comparing physician burnout, empathy and mindfulness scores between     interns in the intervention and control groups. This methodologically rigorous multi-center     cluster RCT will determine if implementing an innovative 6-month mindfulness curriculum     reduces pediatric interns' burnout and improves empathy and mindfulness practice.   "
10492|NCT03148600|"     Multi-centre, assessor-blinded, randomised controlled trial comparing physiotherapist-led     behavioural intervention (including pelvic floor muscle training) to standard care, in the     management of post-operative ileo-anal pouch patients.   "
10493|NCT03148587|"     This study aims to investigate the ability of participants to perform and accurately     interpret the multi-level pregnancy test and the low sensitivity pregnancy test following     medication abortion, without routine provider contact.   "
10494|NCT03148574|"     Bleeding is still the major cause of mortality and morbidity in postpartum period. World     health organization has reported 585000 deaths for pregnancy each year. Twenty five percent     of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal     vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with     emergency hysterectomy   "
10495|NCT03148561|"     Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation,     that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal     bleeding associated abdominal pain and cramping . The miscarriage is named 'complete' or     'incomplete' according to whether or not tissues are retained in the uterus. If a woman has     minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage.     However; if the pregnancy is still inside the uterus but the cervix is open, this is     described as an 'inevitable miscarriage', which it will not usually be possible to save the     fetus.      From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold     standard management' for miscarriage to remove the retained placental tissue. It is quickly     performed and removed almost all the retained products of conception. However, the routine     surgical evacuation of the uterus associated with higher rate of morbidity and mortality and     should be limited for special indications.      Many studies compared the effectiveness of medical treatment compared to surgery in     management of incomplete abortion. There is only one study compared the curettage with     expectant management in those women after medical therapy.However; none of them, looked at     the effectiveness of the second chance of medical treatment in management of incomplete     abortion in trial to avoid the surgical intervention after failure of previous medical     treatment. So we think that the immediate evacuation using surgical intervention is truly     unnecessary in most cases of failed medical abortion and the patients may get benefit from     another trial of medical treatment.   "
10496|NCT03148548|"     Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry.     Using standardized questionnaire, clinical data detailing venous thromboembolism and     contributing VTE risk factors are recorded. Results of technical and laboratory     investigations including screening of thrombophilic disorders were additionally entered into     the database.   "
10497|NCT03148535|"     The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment,     the demographic, symptomatic, neuropsychological, neurobiological and genetic data was     collected. After the completion of the baseline assessment and examination, the patients were     given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment.     Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic     efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The     patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this     study aimed to provide some guidance for the use of antidepressants in patients with bipolar     depression.   "
10498|NCT03148522|"     Major depressive disorder (MDD) is a high-disabling disease. But its etiology and     pathogenesis is not clear, and early recognition, diagnosis and treatment still has many     challenges. Among numerous clinical manifestations of MDD, anhedonia is an important core     symptom of MDD, especially in patients with melancholic features. Our previous studies and     studies abroad have shown that MDD patients had functional abnormality in reward circuit. The     abnormalities of reward-related core areas, such as the prefrontal cortex - nucleus accumbens     - ventral tegmental area were closely associated with the development of MDD, and is an     important neural basis of anhedonia. This study would take the reward circuit as mainline to     carry out the etiology, diagnosis and therapeutic intervention studies of MDD. We would     collect MDD patients with melancholic features and other populations with reward dysfunction.     The neuroimaging techniques, stress assessment, genetic testing and drug intervention methods     would be mainly used in this study. The functional connectivity of reward regions, such as     the ventral striatum, nucleus accumben, and ventral medial prefrontal cortex, would be     analyzed to identify the dysfunction of reward circuit of MDD, and its implication for early     recognition, diagnosis and prediction of treatment efficacy of antidepressants. We would also     investigate the effect of genetic and environmental factors on reward function of MDD and its     biological basis. Finally, through modulating the reward circuit activity using animal     experiments, we would verify and investigate reward dysfunction of MDD and its biological     mechanisms. The project is expected to provide for new evidence for the establishment of     reward mechanism - based objective diagnosis and treatment optimization strategy of MDD.   "
10499|NCT03148509|"     This study will recruit depressed patients unresponsive to selective serotonin reuptake     inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed     patients, schizophrenia, Parkinson's disease with and without depression, and healthy     controls. The subjects need to complete the brain positron emission tomography/magnetic     resonance examination, stress assessment, genetic testing, clinical evaluation and     neuropsychological tests. Using the data, this study aimed to identify the abnormalities of     reward circuit of depression and its differences with other diseases, and its abnormalities     in first-degree relatives of depression. The depressed patients who were ineffective in     treatment with selective serotonin reuptake inhibitor antidepressants were then given     combined medication with dopamine receptor-mediated drugs, including dopamine transporter     inhibitor - bupropion, D2 receptor antagonist - risperidone, or D2 receptor partial agonist -     aripiprazole, to examine the regulation of dopamine pathway and its relationship with the     therapeutic effect. Through the above work, we will provide new evidence for integrating the     biological evidence of dopamine reward pathway into the clinical practice of depression.   "
10500|NCT03148496|"     Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal     surgery, 30% of patients will suffer a major chronic complication with their wound closure in     the first post-operative year. This may include significant wound infections, open wounds,     fluid collections, fascial dehiscence, or incisional hernia. These complications not only     have a substantial impact on the health care system (cost and chronic disease) and the     hospital (cost and space), but most importantly have a substantial impact on the patient.     Major chronic wound complications adversely impact patient quality of life and function.     Potential methods to reduce major wound complications include utilizing specific suturing     techniques or reinforcing the incision line. Suturing technique of small-bites (0.5x0.5 cm     bites) as opposed to large bites (1.0x1.0 cm bites) has been shown to be efficacious in     European populations with a typical body mass index of 20-25 kg/m2. Tissue reinforcement has     been shown to decrease rates of major wound complications in small randomized controlled     trials.      However, the lack of widespread adoption of these practices may be due to issues of     generalizability including strict inclusion criteria, careful patient selection, and small     study size. For example, the generalizability of small bites to an overweight population     (mean BMI in the United States is 28 kg/m2) as opposed to a normal-weight population are     unclear. The use of synthetic materials in comorbid patients or complex settings may risk     major wound complications such as prosthetic infection. Biologic materials have been shown to     be effective in decreasing major wound complications but in different settings. This study is     being done to assess the effectiveness of different efficacious strategies to decrease the     rate of major wound complications following abdominal surgery among high-risk individuals The     researchers hypothesize:        1. Among high-risk patients undergoing abdominal surgery, the use of small-bites closure          as opposed to large-bites closure will increase the proportion of patients who are          free of major, chronic wound complications at 1-year post-operative.        2. Among high-risk patients undergoing abdominal surgery, the biologic tissue reinforcement          of the suture line as opposed to no reinforcement will increase the proportion of          patients who are free of major, chronic wound complications at 1-year post-operative.   "
10501|NCT03148483|"     The improvement of maternal and child health remains a key issue in global health. Production     and improved accessibility of healthy and nutrient-rich milk-based products could potentially     tackle health and nutrition inequalities in low-income countries.      This study will assess the acceptability of a multi-component intervention, including     provision of calcium/vitamin-D fortified milk and periodontal therapy (PT), for improving     maternal periodontal health and metabolic and inflammatory profiles. The IMPROVE trial is a     feasibility randomised controlled trial (RCT) with parallel qualitative process evaluation.     The target population is low-income, pregnant, Brazilian women, with periodontitis, who have     not seen a dentist in the last 6 months. A series of focus group discussions and interviews     with the target population will be conducted to identify key barriers and enablers to     adoption and implementation of the intervention in prenatal clinics in Rio de Janeiro/Brazil.     Participants will be allocated to 4 groups: 1) early PT (during pregnancy) plus fortified     milk; 2) early PT plus plain milk; 3) delayed PT (after delivery) plus fortified milk; 4)     delayed PT plus plain milk.      The final results will contribute to the understanding of the significance of calcium and     vitamin D for short and long-term health and the occurrence of diseases, as well as to inform     the current global debate on vitamin-D supplementation and fortification policy.   "
10502|NCT03148470|"     The purpose of this study is to investigate whether theta burst stimulation (TBS) over the     left dorsolateral prefrontal cortex (DLPFC) influences language switching and cognitive     flexibility. The experimental paradigm will assess the impact of inhibitory and excitatory     prefrontal stimulation by TBS versus sham-TBS over the DLPFC in healthy bilinguals.   "
10503|NCT03148457|"     When to start anticoagulation in patients with an acute ischaemic stroke and atrial     fibrillation (AF) is a relevant unanswered question in clinical practice. Direct oral     anticoagulants (DOACs) are highly effective for secondary stroke prevention in these     patients, but DOACs were never initiated <7 days after stroke onset in recent trials. The     ELAN trial will determine the net benefit of early versus late initiation of DOACs in     patients with acute ischaemic stroke related to AF.      The main objective is to estimate the net benefit of early versus late initiation of DOACs in     patients with acute ischaemic stroke related to AF.      The secondary objectives are to assess all vascular events and all-cause mortality after     early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to     late initiation.   "
10504|NCT03148444|"     Background: Infection of cardiac implantable electronic device including wound and pouch     infection, bacteraemia and endocarditis is a common complication of device insertion. The     role of antibiotic prophylaxis in prevention of this complication is well established. Most     centres in Israel currently prescribe antibiotics about 5 days following the procedure as     well, though clear clinical evidence warranting this practise is lacking. Unnecessary     antibiotic treatment can lead to adverse events including allergy, undesirable effects of the     antibiotics, establishment of resistance to antibiotics among bacteria and further infections     with resistant strains.      Objective: The investigators hope to either establish evidence warranting use of     post-procedural antibiotic treatment or refuting it.      Methods: The investigators intend to recruit about 400 patients a year into both trial group     and control group. The trial group will be treated with post-procedural antibiotics during 5     days, while the control group will receive no post-procedural antibiotics. The endpoints of     the study will include infections related to the implantable device and proposed adverse     effects of the antibiotics. The t-test will be performed in order to evaluate whether benefit     exists concerning one of the groups.   "
10505|NCT03148431|"     The purposes of this study are to determine:        -  The safety of the study drug and any side effects that might be associated with it.        -  How much of the study drug gets into the blood stream and how long it takes the body to          remove it in healthy participants.      Participants will be admitted to the Clinical Research Unit (CRU) for 3 overnight stays.      This study involves a single dose of LY3002815 or placebo given as an injection into the     vein. This study will last approximately 16 weeks including screening. Additional follow-up     may be required.      This study is for research purposes only, and is not intended to treat any medical condition.   "
10506|NCT03148418|"     This is an open-label, multicenter, non-randomized extension study. Participants receiving     atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s)     in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study     treatment at the time of the parent-study closure are eligible for continued treatment in the     extension study. Dosing regimen for a given participant and indication will be according to     the respective parent study. Study treatment in the extension study can continue until     disease progression or beyond if the participant continues to derive clinical benefit in the     judgment of the investigator and if allowed by the parent study or local prescribing     information, death, withdrawal of study consent, unacceptable toxicity, pregnancy,     participant non-compliance, or study termination by the Sponsor, whichever occurs first.   "
10507|NCT03148392|"     The primary objective is to assess any differences in patient quality of life between Cryo     Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The     study will also assess any differences in the amount and duration of pain medication required     after the ablation.   "
10508|NCT03148379|"     To compare economic factors and the rate of adverse events between two types of     instrumentation used for total knee replacement: Single-use Efficiency Instruments with     Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical     Technique   "
10526|NCT03148145|"     The overall goal of this study is to test personalized mobile phone-based physical activity     interventions among students at the University of California, Berkeley. Most physical fitness     applications for smartphones and activity trackers use a constant goal for the number of     steps each day. However, if the step goals are dynamically adjusted according to past     behavior, then the corresponding goals may encourage individuals to increase their physical     activity level. This study consists of a randomized controlled trial in which we are     assessing the efficacy of four different algorithms for calculating personalized goals for     the number of steps each day and for determining which motivational messages to send each     day.   "
11385|NCT03136874|"     The main objective is to study donors' personality and motivations characteristics of the     different recruitment methods and thus to answer questions related to the donation's     approach, its representations as well as motivations and the profile of the donors.   "
10509|NCT03148366|"     Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of     gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients     would fail from first line standard eradication therapy and need second line rescue therapy.     About 15-30% of patient would fail from second line therapy. Bismuth quadruple therapy and     triple therapy containing levofloxacin are currently the recommended rescue therapies in the     second line and third line treatment. Recently, our pilot study showed that modified     sequential therapy containing levofloxacin achieved high eradication rate (95%) in the second     line therapy. The regimen includes a PPI plus amoxicillin for 5-7 days, followed by a PPI     plus levofloxacin and metronidazole for another 5-7 days. However, whether this modified     sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy     in the second line and third line treatment remains unknown. Besides, the impact of these     regimens on the antibiotic resistance , microbiota of gut flora, and metabolic factors     remains unknown.      Aims: Therefore, the investigators aimed to        1. compare the eradication rates and long term re-infection rates of sequential therapy          containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the          second line and third line treatment        2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication          rate of these regimens        3. assess the impact of these eradication regimens on the antibiotic resistance and          microbiota of the gut flora        4. assess the impact of eradication therapy on the metabolic factors   "
10510|NCT03148353|"     Subacromial injection is a useful procedure to counteract shoulder impingement syndrome. With     the aid of high‐resolution ultrasound, the needle can be introduced precisely into the     subacromial/subdeltoid bursa located between the acromion above and the supraspinatus tendon     below. The standardized method allows the injectate to distribute along the subdeltoid bursa,     further reliving pain from subacromial/subdeltoid impingement. In a substantial part of     shoulder pain patients, it is common to accompany pain along the bicipital groove, which the     biceps long head tendon courses through. The biceps long head tendon is attached to the     superior labrum of the glenoid cavity and acts as the second important structure to prevent     upward migration of the humeral head, following the supraspinatus tendon. Overuse injury of     the biceps tendon is a likely cause of anterior shoulder pain. Concomitant administration of     medication into the subacromial bursa and biceps tendon sheath is theoretically more     effective than injection to the subacromial bursa only because the formal procedure targets     two vulnerable structures in shoulder impingement syndrome at once. Regarding the standard     ultrasound‐guided subacromial injection. Therefore, we will conduct a randomized controlled     trial investigating the effectiveness of standard subacromial injection in comparison with a     novel approach simultaneously injecting the subacromial bursa and biceps tendon sheath.   "
10511|NCT03148340|"     The purpose of this study is to assess the ability of the Fluids Monitor to detect     hemispheric bioimpedance asymmetry associated with acute brain pathology in patients     presenting with suspected Acute Ischemic Stroke (AIS).   "
10512|NCT03148327|"     This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca     Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly     reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105     subjects into the study. After an initial safety sample of 15 individuals receiving     durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to     be safe to administer this combination of therapies, the next enrolled subjects will be     randomized in a 1:1 fashion (each subject with a 50-50 chance like the flip of a coin) to     receive either SABR and durvalumab (MEDI 4736), or SABR alone.      Once treatment is completed, all subjects will return to the University of California at Los     Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits     both prior to and after treatment special blood samples will be drawn to be studied by UCLA     scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation     work in the body. It is hoped that we will learn more about the basic safety and science of     durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR     alone, while extending the life and quality of life of these subjects.   "
10513|NCT03148314|"     The world health organization defined abortion or miscarriage as : the expulsion or     extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other     wise product of gestation of any weight irrespective of gestational age and weather or not     there is evidence of life and weather or not the abortion was spontaneous or induced     Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically     recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in     miscarriage. A large majority of those are lost before the menstrual period is missed. More     than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after     For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion,     incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion   "
10514|NCT03148301|"     Spina Bifida can lead to physical neurocognitive and psychological symptoms. Still little is     know about the daily impact of spina bifida on participation possibilities in social life.     This exploratory research project want to investigate which lif choices patients with spina     bifida has to make and in which way their daily life is organized. In a second part, quality     of life will be measured and we hope to discover some dynamics in order to improve patient     care.   "
10527|NCT03148132|"     The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the     pediatric age worldwide. This pathology is characterized for arrest of the normal vascular     and neuronal retina that because of pathological compensatory mechanisms results in     proliferation of vascular tissue that grow in the limit between the vascular retina and the     avascular retina.      The ET-ROP group classified the ROP by those who need treatment immediately or those who     doesn't need treatment, The classification is the following Type 1 ROP-->ROP zone I any stage     with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --> Zone 1,     Stage 2 or 3 without plus, and Zone II, stage 3 without plus.      The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in     observation.   "
11438|NCT03136185|"     This is a Phase 1 open label study of an orally administered LSD1 inhibitor, IMG-7289, in     patients with myelofibrosis.      This study investigates the following:        -  The safety and tolerability of IMG-7289        -  The pharmacokinetics of IMG-7289        -  The pharmacodynamic effect of IMG-7289   "
10515|NCT03148288|"     Irritable bowel syndrome (IBS) is a very common functional gastrointestinal disorder     affecting nearly 20% of the North American population. IBS is characterized by chronic     abdominal, associated with a change in bowel frequency and or consistency that lack a known     structural or anatomic explanation. Current treatment for IBS is primarily symptom-based.     However over a third of patients with IBS fail to respond to currently available therapies.      The prevalence of vitamin D deficiency/insufficiency is estimated in over a billion people     world-wide . Vitamin D has potential mechanisms not only in the balance of calcium and bone     homeostasis, but also a key modulator of the immune system. Vitamin D receptors (VDRs) are     located on all nucleated cells including the GI tract. Thus far, there is already     accumulating evidence for a role for vitamin D supplementation in inflammatory bowel disease     (IBD). A recent systematic review suggested there may be benefits of vitamin D     supplementation in IBD.      Vitamin D insufficiency is widespread in patients with IBS and there is a positive     association between vitamin D status and quality of life. To date, there is no US trial     examining the effect of vitamin d supplementation on IBS symptoms and quality of life in     patients with IBS.   "
10516|NCT03148275|"     This phase II trial studies how well trametinib works in treating patients with epithelioid     hemangioendothelioma that has spread to other places in the body, nearby tissue or lymph     nodes, or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
10517|NCT03148262|"     It is standard practice in the United States and many parts of world to perform     Gastrointestinal (GI) endoscopy with the patient under deep sedation. Obesity is accepted as     a patient specific risk factor for hypoxic events during procedural sedation for GI     endoscopic procedures. The Obese population has a higher prevalence of obstructive sleep     apnea (OSA) which is characterized by repeated obstruction of the upper airway, and leads to     apnea and desaturation. This prospective, randomized study was designed to compare the     effectiveness of the high flow nasal cannula and the standard nasal cannula in morbidly obese     (BMI > 40) patients receiving deep intravenous sedation during colonoscopies. This study will     assess whether use of the high flow nasal cannula (HFNC) leads to less intraoperative     desaturation events compared to the current standard of care.   "
10518|NCT03148249|"     Charles Bonnet Syndrome (CBS) is defined by the occurence of visual hallucinations (VH) in     the absence of any mental disorder. Elderly patients with reduced visual acuity due to     ophthalmic diseases are most affected. Conditions are often associated with the syndrome of     age-related macular degeneration, cataract or glaucoma. Existing data on the syndrome's     prevalence in Europe reveal diverse results. Aim of this study was to assess the prevalence     of CBS in patients with low visual acuity and to evaluate, if an additional therapeutic     interview with and treatment by a psychiatrist is beneficial.   "
10519|NCT03148236|"     Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of     high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered     every six hours with a 30 minute IV infusion time per dose, compared to matched placebo     infusion   "
10520|NCT03148223|"     This study aims to determine if auriculotherapy is effective in the treatment of     dysmenorrhoea. This intervention consists of fixation of yellow mustard seeds at specific     points of the auricular pavilion (or area), with opaque tape. Half of the participants will     have specific ear pinch points stimulated by mustard seeds fixed with opaque plaster, while     the other half will have only the adhesive plasters fixed, without the seeds for stimulation.   "
10521|NCT03148210|"     Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed     asthma or COPD- these people are currently undiagnosed and untreated, even though they may     have significant respiratory symptoms. Our study will use targeted casefinding to find people     with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their     symptoms and their health care use and number of sick days to determine the burden of     undiagnosed respiratory disease in these people. The investigators will then determine     whether early treatment of previously undiagnosed airflow obstruction will improve patients'     health outcomes.   "
10522|NCT03148197|"     COLLECT is a monocentric, prospective, observational study, which aims to assess the     association between changes in the intestinal microbiota and the incidence of     gastrointestinal graft-versus-host diseases (GvHD). Patients admitted for performance of an     allogeneic hematopoietic stem cell transplantation (HSCT) or patients with a first diagnosis     of an acute myeloid leukemia (AML) will be enrolled and stool samples will be analyzed using     next-generation sequencing. In addition to stool, blood and urine samples will be collected     for cytokine and 3-indoxylsulfate analysis.      Exposure to drugs will not be influenced and remains at the discretion of the treating     physician.   "
10523|NCT03148184|"     The purpose of this study is to assess the early outcomes following Reverse Shoulder     Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these     patients, evaluating their clinical outcomes and radiographic appearance.We would like to     know how quickly they are healing and returning to their baseline activities of daily living     and ability to work. This will help when counseling patients prior to surgery as it will give     us a better defined and study supported understanding of the post-operative recovery timeline     in the younger population.   "
10524|NCT03148171|"     The Project PrEP-R intervention is a brief, theory based and culturally sensitive     intervention designed to capitalize on organic yet underutilized social support networks in     the lives of young black men who have sex with men (YBMSM). The intervention has been     developed with input from clients and their support network members, case managers, social     workers, primary care providers. The goal of the intervention is to improve retention in PrEP     care for young Black MSM.   "
10525|NCT03148158|"     This will be a prospective trial comparing the perspective gross morphological of bladder     tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient     rigid cystoscopy done by senior staff and their prediction of the degree of invasion of     bladder tumor plus the prediction of the grade compared with the standard pathological     result.      Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy     will be done.      In the long run of the study, the prognostic gross morphology with recurrence, progression     and cancer specific survival will be assessed.   "
49652|NCT02635737|"     This is a single site, single arm, unblinded safety and feasibility cohort study     investigating the use of magnetic marker seeds to localise breast tumours.   "
10528|NCT03148119|"     A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled     with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed.     The study will test the efficacy of administering this agent (QRH-882260 Heptapeptide) to     human subjects undergoing clinically-indicated colonoscopy for endoscopic resection of known     colonic adenomas or for surveillance biopsies of known dysplasia in the setting of irritable     bowel disease (IBD). Up to 120 evaluable subjects will be enrolled.      Subjects will be recruited around scheduled standard of care procedures. The endoscopists     performing the procedures are all endoscopists credentialed at the University of Michigan to     do these procedures. Urine for dipstick pregnancy testing (if applicable) will be collected     before the procedure, along with medical information. Vital signs are routinely monitored     throughout the clinical procedure and are available in the electronic medical record. The     endoscopy will proceed per the University of Michigan Health System (UMHS) standard of care.     The endoscopist performing the clinical procedure will evaluate the potential risk (if any)     for the subject to continue with the procedure or study. Five mL of the reconstituted     QRH-882260 Heptapeptide (~100 μM) will be sprayed onto the site of interest through a     catheter in the endoscope. Five minutes after QRH-882260 Heptapeptide application, the     unbound peptide will be washed off using the endogator irrigator and the residual liquid will     be suctioned. Pictures with white-light and fluorescence will be taken with the scanning     fiber based molecular imaging endoscopic probe inserted via the instrument channel of the     standard endoscope before the QRH-882260 Heptapeptide application, immediately after     application and then again after the QRH-882260 Heptapeptide will be washed off. The area of     interest identified will be resected/biopsied per discretion of the endoscopist per clinical     care. All specimens taken are for clinical care only (not research use) and will be sent for     routine histology per UMHS standard of care.   "
10529|NCT03148106|"     The purpose of this study is to find out what are the best settings for applying electrical     nerve stimulation over the skin for the short-term improvement of hand dysfunction after a     stroke. The ultimate goal is to some day design an effective long-term training program to     help someone recovery their ability to use their hands and function independently at home and     in society. In order to know how to apply electrical nerve stimulation to produce a good     long-term effect on hand dysfunction, we first need to know how to make it work best in the     short-term, and improve our understanding of for whom it works and how it works.We will use a     commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently     apply electrical nerve stimulation over the skin of the affected arm. This is a portable,     safe and easy to use device designed for patients to operate in their homes.   "
10530|NCT03148093|"     The CHOICE Registry will describe real-world treatment patterns and physician and patient     (and caregiver)-reported outcomes associated with patients who have progressed beyond 2nd     line metastatic colorectal cancer.   "
10531|NCT03148080|"     To document levels of labor force participation, occupation, educational attainment, and     financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.   "
10532|NCT03148067|"     Diaphyseal femoral and tibial fractures are in the spotlight within the     traumatology-orthopedics scenario. Intramedullary nailing (IMN) remains the method of choice     for treating these fractures, both open and closed ones. Occurrences of surgical site     infection (SSI) related to this type of osteosynthesis are a challenge for all the     professionals involved in patient healthcare. The reported incidence of SSI after IMN ranges     from 0.9 to 17.5%. The majority of the data comes from retrospective studies and as part of     case series descriptions, with little detail about the criteria used for defining and     searching for cases of infection. Regarding the potential risk factors for this complication,     previous use of external fixators, occurrence of open fractures and the severity of exposure     according to the Gustilo-Anderson classification were indicated in a few retrospective     studies as being possibly related to this complication. The objectives of the present     observational cohort study are: 1. To determine the incidence of SSI related to IMN for     fixation of diaphyseal femoral and tibial fractures in patients treated in a university     traumatology and orthopedics reference hospital in São Paulo, Brazil; 2. To evaluate the risk     factors related to the occurrence of this type of infection.   "
10533|NCT03148054|"     Patients undergoing elective surgery for left-sided colon resection are asked to participate     in this study: Every patient undergoes two types of examinations (endoscopy, CT scan) on day     3, 4 or 5 postoperatively. These two procedures are subject to investigation in terms of     their accuracy (sensitivity, specificity) in detection of anastomotic leaks. The patients are     followed up until day 42 postoperatively. There are no other specific tests or examinations     within the study. Information and informed consent are obtained preoperatively.   "
10534|NCT03148041|"     The investigator of this study would like to test the hypothesis of the effectiveness of     health education program on level of awareness of stroke among population at risk whom     attending the primary health care center in Jeddah, in Saudi Arabia. The investigator will     divide the participants into two groups. The intervention group whom will have the intensive     health education program, and the control group whom will have the routine care. Participants     will be followed up for 3 months to assess the effect of different health education programs     on their level of awareness about stroke. Also The investigator will relate different     socioeconomic factors to level of awareness.   "
10535|NCT03148028|"     The investigators wish to characterize alterations in the architecture and function of immune     cells in patients with a primary immunodeficiency that also develop inflammatory bowel     disease. In addition, The investigators' goal is to characterize the microbiome of these     patients, in order to determine whether specific microbial alterations are related to     inflammation.   "
10536|NCT03148015|"     This project is an immunohistochemical study of archived patient breast tissue, specifically     pre-invasive lesion specimens. The purpose is the discovery of novel molecular markers of     pre-invasive breast lesions. These novel markers, once validated in this study, can serve as     targets for individualized prevention therapy, neoadjuvant therapy for ductal carcinoma in     situ (DCIS), or predictors of lesion aggressiveness. We have discovered two novel classes of     DCIS molecular pathways required for the survival of DCIS neoplastic cells that will serve as     the basis for the candidate molecules to be evaluated in this proposed study. The first class     of DCIS molecular markers is autophagy, a cell survival mechanism that we discovered to be     highly augmented in the hypoxic and nutrient deprived intraductal neoplastic cells of human     DCIS (1-4). The second class of biomarker is calcium efflux that is mediated in breast cells     by the calcium export pump Plasma Membrane Calcium ATPase (PMCA2) (5, 6). During normal     lactation, breast epithelium pumps large concentrations of calcium into milk. In neoplastic     lesions, calcium is exported by PMCA2 as a cell survival mechanism, since cells under     metabolic stress accumulate calcium to a toxic level. Calcium export in DCIS may also     contribute to intraductal calcifications, a hallmark of high grade DCIS and the most common     marker of DCIS on mammography (7).      Sentara cares for hundreds of patients per year who are diagnosed with breast pre-invasive     lesions, including atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), and     lobular carcinoma in situ (LCIS). Sentara treats 25% of the women with breast cancer in     Virginia. Coupled with information from the Sentara Cancer Registry, Dr. Hoefer or a research     team member will identify eligible patients with ADH, DCIS, and/or LCIS at the time of the     core biopsy diagnosis, surgical therapy, and/or upon lesion recurrence. After receiving     written informed consent from the eligible patients, Sentara Pathology will retrieve the     corresponding tissue blocks. The recut tissue sections will be processed at George Mason     University, Center for Applied Proteomics and Molecular Medicine for markers relevant to     calcium signaling, Vitamin D response, proliferation, autophagy and inflammation. Combined     with the translational research expertise/technology in the Center for Applied Proteomics and     Molecular Medicine at George Mason University, Sentara's diverse patient cohort provides an     opportunity to address the most fundamental unanswered questions surrounding the etiology,     progression, and therapy of pre-invasive breast lesions.   "
10537|NCT03148002|"     Constipation is a common condition, which occurs one in four Canadians. Maintaining regular     bowel movements is imperative because constipation can affect the quality of PD dialysate     flow and result in an unwanted effect on the dialysis adequacy.      There is limited data on how to best manage constipation in the peritoneal dialysis     population. Polyethylene glycol (PEG) is an osmotic laxative that is becoming popular for     prevention and treatment of constipation across Canada. Although some PD programs in Canada     have already converted to PEG for management of constipation, more research in this     population would help guide practice. For now, the current PD bowel regimen at the Nova     Scotia Health Authority (NSHA) includes daily preventative therapy using a stimulant     laxative, senna, along with an osmotic laxative, lactulose, for acute constipation.      The investigators will review all patients in the NSHA PD program who have regular or recent     laxative use for participation in this study. Patients included in this study will be     randomly assigned to the Current Bowel Protocol or the PEG Bowel Protocol for 8 weeks.      The goal is to determine if the PEG Bowel Protocol is as effective and safe for the     prevention of constipation as the Current Bowel Protocol used in the PD Program. The     investigators will use bowel function diaries and patient surveys to determine efficacy and     safety outcomes.   "
10538|NCT03147989|"     This is a retrospective study to collect already existing data and images from patients ≥ 2     years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10     mmol/kg dose or the half dose of 0.05 mmol/kg. The MRI images of all included patients will     be prospectively reviewed in a blinded read to compare the efficacy of the two doses.   "
10539|NCT03147976|"     This is a Phase 2 Study of AMG 337 in Subjects With Advanced or Metastatic Solid Tumors That     Overexpress MET   "
10540|NCT03147963|"     A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent     Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a     3-Weeks Regimen   "
10541|NCT03147950|"     compare the prone with the prone-flexed position accessibility of upper and middle calyceal     approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo     system with Categorisation of PCNL-specific complications according to Clavien-Dindo     classification score   "
10542|NCT03147937|"     Patients assume that cognitive performance rapidly returns to baseline after anesthesia and     surgery. Several studies have shown that one week after major non-cardiac surgery about 27%     of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months.     Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly     reduces quality of life. Identifying risk factors for POCD is important because it is     associated with prolonged hospital stay, loss of independence, and premature retirement.     There is an urgent need to measure and document the level of cognitive change associated with     surgery with an easy to use tool, both prior to admission and after discharge. This     information can be used to plan appropriate care paths and to identify or test the efficacy     of potential new treatments to alter the negative trajectory.   "
10543|NCT03147924|"     This study is taking place to examine the preliminary effects of improvisational therapy     (improv group) on social anxiety for youth at the Youth Wellness Centre (YWC). The improv     group will run for 12-weeks as a drop-in group. A typical session will begin with stretching,     simple breathing and an activity to promote group cohesion. Following this, improvisation     games and activities will be introduced with the goal of promoting the following skills:     assertiveness, acceptance, problem solving, co-operate skills, non-verbal communication,     mindfulness, and memory. Youth who consent to the study will be asked to complete a set of     brief questionnaires the first time they attend one of the sessions. Youth who have attended     at least 3 sessions will be asked again to complete questionnaires following the completion     of week 12 session. Youth will also rate their anxiety and distress on a simple rating scale     at the beginning and end of each session. Additionally, all participants (who have attended     three or more sessions) will be invited to complete a 30 to 45 minute qualitative interview     following the 12 week session. Participants are predicted to show a decrease in social     anxiety, generalized anxiety and depression symptoms, and an increase in self-esteem, and     perceived social support.   "
10544|NCT03147911|"     The purposes of this study are to assess the prevalence of patients with a low risk of stroke     or systemic embolism based on a CHA2DS2-VASc score among patients who have an AF-related     thromboembolism and to identify the clinical and genetic factors associated with     thromboembolism in AF patients with a CHA2DS2-VA score of 0 or 1.   "
10545|NCT03147898|"     This is an observational study designed to describe the immune profile of toddlers and     preschoolers with acellular priming after receiving a booster dose of pertussis vaccine.   "
10546|NCT03147885|"     This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor     (selective inhibitor of nuclear export) in combination with standard therapy for B cell     Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose     of Selinexor in combination with RCHOP and also study the efficacy of this combination for     therapy of B cell Non-Hodgkin's lymphoma. Giving Selinexor plus chemotherapy may work better     in treating patients with B cell non-Hodgkin lymphoma.   "
10547|NCT03147872|"     Clinical in vitro fertilization relies on successful embryo culture. The primary goal of     embryo culture is to attempt to recapitulate the in vivo conditions as much as possible. In     the past decade, the majority embryo culture has been performed at 5% oxygen due to the     discovery that the oxygen tension in the fallopian tube (where the embryo is located for the     first 3 days after fertilization) is 5%. However, relatively recent studies have demonstrated     that the oxygen tension in the uterus (where the embryo is located after day 3) is closer to     2%. This study is a randomized controlled trial that will compare pregnancy rates between     embryos cultured in 2% versus 5% after day 3 of development.   "
10575|NCT03147495|"     This study aims to research on the association between the inclination of the proximal     tibiofibular joint surface and medial compartment knee osteoarthritis. The proximal     tibiofibular joint radiographs of the participants will be taken. The angle of inclination of     the proximal tibiofibular joint surface in two groups will be compared.   "
10576|NCT03146663|"     This study will evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2)     in patients with ovarian cancer. The primary objective is to determine the anti-tumor     activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).   "
10548|NCT03147859|"     Background:      In nearly all people with human immunodeficiency virus (HIV) infection, immunity cannot     either control or eradicate the infection. There are good medicinal treatments, collectively     called ART (antiretroviral therapy) which control HIV infection by suppressing the virus in     the bloodstream. ART is needed for life, and if a person stops taking ART the HIV infection     returns in the bloodstream. So, there is good treatment, but no cure. The researchers want to     test whether a period of treatment with vedolizumab can be used to control HIV infection in     the bloodstream in persons with HIV on ART, after stopping ART.      Objective:      To determine whether vedolizumab is safe and tolerable in people with HIV, to assess the     safety of an analytical treatment interruption (ATI), and to determine whether vedolizumab     can control HIV infection in the bloodstream without the use of ART.      Eligibility:      Adults 18-65 with HIV who are being treated with ART      Design:      Participants will be screened with: Physical exam, medical history, blood and urine tests     Participants will have a baseline visit which will include repeat of the screening testing.      Participants will then present for their first study visit which will include: receiving     vedolizumab infusions through an arm vein, repeats of the baseline testing. Participants will     then have serial visits on a pre-specific schedule to receive ongoing vedolizumab doses every     2-4 weeks until week 20. Each visit will also include repeat of the baseline tests.      After week 6 and before week 7 patients will discontinue ART. After the final infusion of     vedolizumab at week 20 patients will continue to be assessed with physical exam, medical     history, and repeat of the baseline testing every 4 weeks up to 1 year.      ART will be re-started for participants if the level of HIV in the blood becomes too high,     persists for too long, or if the CD4 count decreases by too much.   "
10549|NCT03147846|"     Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm     neonates. A randomized controlled trial   "
10550|NCT03147833|"     32 runners will be randomized into two groups. The duration of the intervention is one week     including a strenuous endurance training program. Group 1 receive a protein beverage before     each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test     before and after the intervention and blood sampling before and during the intervention to     check for markers for muscle damage.   "
10551|NCT03147807|"     The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing     enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably     intensivists, to prescribe more carbapenems, particularly in the most fragile patients such     as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of     carbapenem resistance mechanisms. Moreover, several preliminary results suggest that     carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of     carbapenem exposure is widely desired both by national and international antibiotic plans.     Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce     inappropriate exposure to carbapenems could be a relevant solution. Due to its good     diagnostic performance, the betaLACTA® test could meet these objectives.      Experimental plan :      Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic     medical device (close to a phase III study), comparing two parallel groups:        -  Experimental group: early carbapenems de-escalation since the second dose, guided by          results of the betaLACTA® test performed directly on the bacterial pellet from the          microbiological sample positive on direct examination.        -  Control group: carbapenems de-escalation guided by definitive results of the antibiotic          susceptibility test obtained 48 to 72h after microbiological sampling (reference          strategy).   "
10552|NCT03147794|"     A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga     Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb     (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a     results of stroke or spinal cord injury (7). It is a non-invasive application that delivers     electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by     Health Canada and is indicated as a functional electrical stimulator for improvement of arm     and hand function and active range of motion in patients with hemiplegia due to stroke or     upper limb paralysis due to C3-C7 spinal cord injury. In a randomized controlled trial     looking at adults with acute stroke and limited or complete immobility of the arm, FES and     intensive therapy was shown to have significant improvement of hand function compared to the     control group that was exposed to intensive therapy only (8). Limited research using MyndMove     to administer FES has been conducted for pediatric populations, however there is significant     potential for FES and intensive therapy to improve hand function for children with upper     extremity hemiparesis using MyndMove technology. Before the efficacy of MyndMove therapy can     be evaluated in children age 3 to 6, the tolerability of the system must first be evaluated     and proven for this age group.   "
10553|NCT03147781|"     The aim of this study is to function as a pilot study in evaluating the effects of auricular     therapy (AT) on lactation for women in the immediate post cesarean period while examining the     feasibility of the three-parallel-arm, sham-controlled randomized design. The study     hypothesizes that post cesarean women who receive AT with standard care for 96 hours     postpartum have earlier onset of lactogenesis II and larger milk production when compared     with women who receive sham AT with standard care or standard care alone.   "
10554|NCT03147768|"     The laser tissue welding device is intended for use in patients requiring sealing of the     pancreas after partial pancreatectomy, and including those patients who are fully heparinized     or have hemodilutional coagulation failure.      The hypothesis is that the laser tissue welding device is safe and effective in sealing the     pancreas, thereby decreasing the blood loss (operative and post-operative), and pancreatic     juice leakage for patients when the Laser Tissue Welding device is used after pancreatic     resection.   "
10555|NCT03147755|"     Oropharyngeal dysphagia (OD) is a common morbidity after stroke that disrupts swallowing     physiology. The investigators aimed at evaluating the prevalence of oropharyngeal dysphagia     (OD) after stroke and analysing the risk factors and associated complications.   "
10556|NCT03147742|"     To provide ruxolitinib through an expanded access program for the treatment of     graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to     participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in     the treatment of GVHD.   "
10577|NCT03146650|"     This phase II trial studies the efficacy (the effect on the tumor) and the safety (the effect     on the body) of the study drugs when given as a combination in participants with this type of     cancer. Another purpose of the study is to see which tumor markers (proteins in the blood     that the body produces in response to the cancer) lead to better results in participants     treated with the study drugs. Nivolumab and ipilimumab are antibodies, which are human     proteins that recognize and attach to a part of the tumor and/or body's immune cells. They     work in slightly different ways to activate the immune system and help the body's immune     system to work against tumor cells. Nivolumab and ipilimumab are investigational because they     are not approved by the FDA to be used for the type of cancer being studied.   "
10557|NCT03147729|"     Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and     gases, which can help to improve quality of life. Based on these experiences objectives were     drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life     of patients with anal incontinence, to correlate the anal incontinence severity and to     evaluate a sexual function and to verify an influence with radiofrequency treatment. It is a     blind randomized clinical trial. For the collection of data it was used a fecal quality of     life questionnaire (FIQL). The questionnaire assess the severity of Anal Incontinence (FISI),     the degree of patient's satisfaction using a five-point scale (Likert) and a visual analogue     EVA scale). It was divided in two groups, in one group it was used radiofrequency and pelvic     exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises.     It was accomplished in eight sections. As a result, it is expected the efficiency of the     treatment of radiofrequency in the quality of life, in sexual function and in it's severity.   "
10558|NCT03147716|"     This study tests the effectiveness of different strategies for engaging parents into an     evidence-based parenting skills intervention, the Triple P Positive Parenting Program,     offered universally to parents of children attending one of six public elementary schools.   "
10559|NCT03147703|"     The purpose of this investigation is to test the hypothesis that in humans, eating late may     induce changes in saliva microbiota daily rhythms towards a more obesogenic and a less     responsiveness to dietary treatments profile. These changes in microbiota may partly explain     the weight loss difficulties that characterized late eaters in previous studies. Thus, the     aim is to analyze the effect of the timing of food intake in humans' saliva microbiome daily     rhythms in a randomized, crossover interventional study, in order to achieve.   "
10560|NCT03147690|"     This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in     diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be     enrolled across approximately 8 sites in the US. All subjects will have had a Computerized     Tomography (CT) scan as part of standard of care, confirming at least one solid organ     abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed     by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and     contrast-enhanced ultrasound results will be compared to the CT scan results. The study     procedures will take place within 48 hours of injury.   "
10561|NCT03147677|"     This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study,     for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be     enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. One group receive     Alfacalcidol 0.25ug/day and Irbesartan 150mg/day for 16 consecutive weeks. The second group     receive Alfacalcidol 0.25ug/day alone for 16 consecutive weeks. The third group receive     Irbesartan 150mg/day alone for 16 consecutive weeks. All subjects will be followed up for 4     weeks after medication is over. A total of 4 visits have been scheduled for this study at     week 0, week 8, week 16, week 20.   "
10562|NCT03147664|"     Introduction: Enzyme replacement therapy (ERT) with Myozyme improved the prospect of Pompe     disease patients. Our aim was to evaluate ERT acute effect on exercise capacity in pediatric     Pompe patients.      Methods: Pompe patients (10-19 years) were evaluated before and two days after ERT using     cardiopulmonary exercise testing (CPET), six minutes walking test (6MWT) and motor function     test (GMFM-88).   "
10563|NCT03147651|"     Introduction: Bronchiectasis is a chronic lung disease in which the underlying condition     causes permanent damage to the conducting airways. Bronchiectasis is associated with     considerable morbidity and poor quality of life. While cystic fibrosis (CF) is the most     common cause of bronchiectasis in childhood, non-CF bronchiectasis is associated with a wide     variety of disorders. CF bronchiectasis patients show reduced daily habitual physical     activity and exercise capacity. Cardiopulmonary exercise test (CPET) is increasingly gaining     importance in clinical medicine and considered the gold standard exercise test for assessing     aerobic exercise capacity. The test objectively evaluates exercise physiological functions,     may help assess morbidity and predict the outcome and mortality in different clinical     circumstances and may serve as a basis for individualized exercise prescription within the     limitation of the disease. Unlike CPET in CF, there is a paucity of data on exercise capacity     using CPET in non- CF bronchiectasis patients, and on the implications of physical activity     on non- CF bronchiectasis morbidity and mortality.      Aim: To evaluate and compare exercise capacity in CF and non-CF bronchiectasis patients.      Methods: This will be a cross-sectional retrospective/prospective study population. The     retrospective study will include data analysis of patients that preformed CPET as part of     their clinical evaluation. In the prospective study, patients that are scheduled to perform     CPET as part of their clinical evaluation will sign (or legal guardian) informed consent     prior to participation. Patients will be recruited from the exercise clinic at the Pediatric     Pulmonary Institute at the Rappaport Children's Hospital. Inclusion criteria: 1. Children and     adults (age >7 years, height >125cm), with CF and non CF bronchiectasis. 2. Completed a     maximal CPET test according to accepted criteria; (maximal VO2 > 80% predicted, maximal heart     rate > 80% predicted, acceptable RER (RER > 1.0 in children (under 18 years), RER > 1.05 for     adults) or reaching a VO2 plateau..3. Evidence of bronchiectasis in computed tomography (CT).      Exclusions criteria: preforming submaximal CPET, lack of data from the exercise test,     exacerbation of patient's condition within three days before the exercise evaluation,     relevant related chronic diseases that affecting test results.   "
10564|NCT03147638|"     Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For     Heparin-Induced Thrombocytopenia (HIT)   "
10565|NCT03147625|"     Elderly residing in elderly-only households are more vulnerable as they are socially     isolated, suffer from poorer health outcomes, and are less likely to adopt health-promoting     behaviors. While multi-dimensional preventive home visits provide older adults with the     individualized care to cope with living in their homes, group-based education promotes peer     learning and allows for social interaction. Elderly residing in elderly-only households can     reap the benefits derived from the coaction of preventive home visits and group-based     education, providing them with the personalized care to age healthily in their homes and a     platform to develop social connectedness with their peers. This study uses the combination of     preventive home visit and group-based education program to promote healthy aging in elderly     living in elderly-only households.      Using a randomized controlled trial, the study aims to evaluate the effectiveness of a     12-week health promotion and risk prevention program, named Salutogenic Healthy Aging Program     Embracement (SHAPE) for elderly-only households. Participants in the experimental group will     receive 2 home visits, 10-weekly group-based activity sessions and a SHAPE health-promotion     booklet. A process evaluation using face-to-face interviews will also be conducted for     elderly receiving SHAPE to explore their views on the program.      The use of salutogenic model breaks away from the negatively connoted conventional biomedical     model and addresses on optimization of positive health. Ultimately, the SHAPE intervention     seeks to identify, equip and strengthen resources for elderly-only households, encouraging     the adaption of health-promoting and risk-preventing actions to achieve better health     outcomes and higher quality of life.   "
10566|NCT03147612|"     The goal of this clinical research study is to learn how well ponatinib combined with     low-intensity chemotherapy may control Philadelphia chromosome-positive (Ph+) or BCR-ABL     positive acute lymphoblastic leukemia (ALL) in patients who are at least 60 years old.      In elderly patients with ALL, intensive chemotherapy is effective but causes a lot of side     effects, some of which are very serious and can be life-threatening. Researchers want to     learn if using low-intensity chemotherapy in this study can achieve the same effect as     high-intensity chemotherapy in the long run but with fewer side effects.      Ph+ and BCR-ABL positive are types of genetic mutations (changes).      The safety and effectiveness of the study drug combined with low-intensity chemotherapy will     also be studied.      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or     death. A blood clot may occur within 2 weeks after you start taking the drug. About 41%     (about 2 in 5) of patients taking the drug form an abnormal clot. Blood clots can occur in     patients that do not have other known risk factors for forming clots. If you develop a blood     clot, you will need to stop taking ponatinib. In some cases, emergency surgery could be     needed to remove the clot and restore blood flow.   "
10567|NCT03147599|"     A randomized controlled trial to assess clinically the efficacy of the selective ileum     spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal     neobladders and quality of life effect within 1 year post-surgery.   "
10568|NCT03147586|"     This is a randomised double-blinded placebo-controlled phase IV trial with two parallel     treatment groups receiving either immune nutrition diet (IND) or conventional diet for 2weeks     peri-radical cystectomy. Patients will be stratified according to the gender, body mass     index, and the type of urinary diversion (orthotopic neobladder or ileal conduit). The     primary end-point is to determine, in intention to treat analysis, the influence of IND on     90-day postoperative morbidity. Secondary study end-points will be the effect of IND on     infectious as well as non-infectious complications over 90 days, compliance and adverse     effects of IND. Finally, an ancillary study will be performed to evaluate whether the IND     costs could counterbalance, by its benefits, the health care costs.It is envisaged to finish     patients' recruitment within 24 months   "
10569|NCT03147573|"     Blood pressure measurement methods and conditions are determinants of hypertension diagnosis.     The classical methods such as office blood pressure measurement (OBPM) and home blood     pressure monitoring (HBPM) have significant limitations. A recent British guideline     recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these     devices are not available at all health centers and they can only be used by one patient per     day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM),     to diagnose the hypertension.      Participants with suspected hypertension will be recruited from a population of patients seen     at three primary health centers in an urban area. According to the sample size estimation, a     minimum sample size of 214 participants would be needed for the study. Four diagnostic tests     will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour     monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be     compared to all other monitoring methods using the correlation coefficients and Bland Altman     plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and     specificity of the methods will also be calculated.   "
10570|NCT03147560|"     The purpose of this study is to evaluate the immunogenicity and safety of different     sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.   "
10571|NCT03147547|"     This study evaluated the effectiveness of strategies for engaging parents into parenting     programs. Engagement strategies included a booklet showing testimonial quotes and photos from     prior participants, a recommendation to attend for the child's teacher, and a motivational     call from the parenting program provider. It was hypothesized that the combination of     engagement strategies would increase attendance at a parenting intervention compared to     receiving only a promotional brochure and research interview.   "
10572|NCT03147534|"     Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques     presently in use for measuring temperature in infants and children in a Canadian clinical     setting.   "
10573|NCT03147521|"     Accidental falls represents an elderly very important health problem, both in the community     and within the hospital. The aim of this research project is to evaluate the effectiveness of     accidental falls prevention care bundle in geriatrics, internal medicine, post acute, and     rehabilitation wards, in terms of incidence and outcome reduction. It will be also     investigated the cost effectiveness ratio, in terms of falls avoided, care bundle     implementation costs, and falls related healthcare costs. The study will permit to evaluate     the implementation feasibleness in time, considering the study will last for 20 months.   "
10574|NCT03147508|"     The goal of is this study is to investigate the reliability and validity of a classification     system for neck pain patients. In a previous study clinical experts were asked about the     clinical criteria they considered to be determinative for 5 predefined dysfunction patterns     in patients with neck problems: 1) articular, 2) myofascial, 3) neural, 4) central, and 5)     sensorimotor control dysfunction pattern. This Delphi survey revealed a list of pertinent     anamnestic and clinical criteria per dysfunction pattern.      In the present study we will collect anamnestic and clinical data of 1000 neck pain patients.     This will be obtained by approximately 20 clinicians that fill out a standardized     registration form at the intake of their patients with neck pain.      The therapists and patients will receive an informed consent that clarifies the purpose of     the study and what happens next with the collected data.      Per patient the therapist indicates the dominant clinical pattern based on his/her     experience. Prior to the data analysis, the researchers will be blinded to the patient     identification data. Subsequent, the registration forms will be screened for the presence of     clinical criteria (obtained from previous Delphi study), independent of the therapist's     diagnosis/conclusions. A second independent researcher will gather this information, which     will be used for statistical analysis, in order to investigate which clinical criteria can be     considered as determinative for a particular pattern. Outcome measures for these analysis     are:        -  sensitivity and classification specificity        -  (positive and negative) likelihood ratios        -  odds ratios        -  diagnostic accuracy   "
35696|NCT02818543|"     The purpose of this study to assess the pharmacokinetic profile in patients with active     ulcerative colitis and compare it to the experience in healthy volunteers.   "
10581|NCT03146598|"     Transverse-plane foot deformities are a frequently encountered issue in children with     neurological disorders. They are the source of many symptoms, such as pain and walking     difficulties, making their prevention very important. It is thus important to prevent the     occurrence of transverse-plane foot deformities and limit their development regarding the     high risk of morbidity. In order to prevent such deformities, in the department of pediatric     physical medicine and rehabilitation department of Lyon, since 2001 the investigator use a     side pole static ankle foot orthosis (SPS AFO) in children with a neurological disorder     predisposing such deformities. The aim of the study this study is to describe the use,     tolerability and potential side effects of this orthosis in children with neurological     disorders from the investigator's department   "
10582|NCT03146585|"     The hypothesis to be tested: GCX damage and its dynamics correlate to various patient related     factors and to using organ-supporting measures. There is a correlation between length of     organ support and GCX damage.      The aim of the study: Evaluation of the relationship between GCX damage and duration of     various organ supporting measures.      Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring     organ supporting therapy.      Sample size: We plan enrollment of 75 patients on invasive ventilatory support in the     duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and     20 patients with target temperature management for neuroprotection.      Intervention: none Data to be recorded and analysed: Demographics, type of patients (trauma,     post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid     balance, presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging     at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7     and/or at discharge or before death, microcirculatory data, and Perfused Boundary Region.   "
10583|NCT03146572|"     The objective of this study to evaluate potential impact of a brief, low-cost primary     care-based intervention of parenting self-efficacy, knowledge, and behavior.   "
10584|NCT03146559|"     The purpose of this study is to investigate learning transfer from the healthy hand to the     paretic hand in stroke patients. EMG signals from the healthy hand - while performing wrist     dorsi flexion movement - will be used to activate electric muscles stimulation of the dorsi     flexors of the paretic hand.   "
10585|NCT03146546|"     Sepsis-induced immunosuppression affects all types of immune cells. Neutrophils are pivotal     components of innate immunity and provide the first line of defense against invading     microorganisms. After recruitment to the site of invading microorganisms, they phagocytose,     kill and digest the microorganisms via well-orchestrated processes involving reactive oxygen     species (ROS). However, neutrophils in sepsis demonstrate an immunosuppressed phenotype.(1)     Reduced bacterial clearance, diminished production of reactive oxygen species (ROS), and     impaired recruitment to the site of infection are the most prominent features.(2-4) Available     data also reveal that neutrophil dysfunction develops prior to secondary infections, and     patients with the most severely impaired neutrophil function carry the highest risk for     secondary infections.(3) However, the mechanisms involved are still poorly understood.      Hyperresistinemia in sepsis has been associated with a greater disease severity and a worse     outcome.(5-7). The Investigator's prior work in vitro has demonstrated that hyperresistinemia     reversibly hinders neutrophil migration by impairing F-actin formation.(8) The current     project revolves around the overall hypothesis that resistin also impairs bacterial killing     by inhibiting the intracellular generation of reactive oxygen species.      While the study team has accumulated preliminary in vitro data supporting the inhibitory     effect of resistin on neutrophils, it is imperative to confirm these findings in vivo.     Specifically, the study team will need to study how serum resistin levels differ in patients     with septic shock and acute kidney injury (AKI). Furthermore, it is essential to see how     neutrophil function differs when exposed to serum from these two different patient     populations (septic shock versus septic shock + AKI).   "
10586|NCT03146533|"     This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and     feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory     patients with CD19+ B cell lymphoma.   "
10587|NCT03146520|"     Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical     sensitivity and specificity in detection of colorectal cancer.   "
10588|NCT03146507|"     The fetal heart plays a central role in the adaptive mechanisms for hypoxemia and placental     insufficiency. Longitudinal data on the hemodynamic sequence of the natural history of fetal     growth restriction show that the umbilical artery and middle cerebral artery are the first     variables to become abnormal . These arterial Doppler abnormalities are followed by     abnormalities in the right cardiac diastolic indices, followed by the right cardiac systolic     indices, and finally by both left diastolic and systolic cardiac indices .      Preserving the left systolic function as the last variable to become abnormal ensures an     adequate left ventricular output , which supplies the cerebral and coronary circulations.This     defence is contingent on the fetal cardiovascular system, which in late gestation adopts     strategies to decrease oxygen consumption and redistribute the cardiac output away from     peripheral vascular beds and towards essential circulations, such as those perfusing the     brain.      Adding cardiac Doppler may improve management of the IUGR fetus(intrauterine growth     retardation), Doppler ultrasound is valuable in defining the degree of cardiovascular     compromise in at-risk pregnancies. The severity of fetal blood flow redistribution shows the     degree of fetal adaptation and provides information on how long the pregnancy can be     continued safely.      The aime of the study is assessment of cardiac output redistribution in fetal hypoxia by     estimating relative right to left side cardiac output wich reflect cardiac sparing in (IUGR).   "
10589|NCT03147469|"     The influence of different head and neck positions on the effectiveness of ventilation with     the Ambu AuraGain airway remains unevaluated.      This study aimed to evaluate the influence of different head and neck positions on     ventilation with the AuraGain airway.      AuraGain will be placed in all patients, and mechanical ventilation will be performed using a     volume-controlled mode with a tidal volume of 10 ml/kg.      The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and     ventilation score will be assessed first for the neutral head position and then for the     extended, flexed, and rotated head positions in a random order.      Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.   "
10590|NCT03147456|"     One of the most common post-operative deficiencies or complications of bariatric surgery is     protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro-     and macronutrient deficiencies that can lead to deleterious consequences. A protein-rich diet     make a person feel satiety and thereby the consumption will be low in overall energy intake.     The objectives of our study are. The aim of this study is to assess the effect of protein     supplementation on changes in health parameters such as fat mass, muscle mass, weigh change,     protein (total and albumin), Vit B12, Zinc and Magnesium, in Qatari patients post bariatric     surgery. Our participants are Qatari aged 18-45 years males and females recruited from the     bariatric surgery centers of 2 major HMC hospitals (HGH hospital) and will be randomized to     receive either the protein supplement (treatment group) or a dietary advice (control group).     All participants will be equally followed and monitored for 3 months and data on the above     parameters will be collected, together with other population characteristics, at Baseline, 1     month and 3 month. Data will then be analyzed using the most up-to-date SPSS statistical     package to assess the effect of protein supplementation on the parameters of interest.     Statistical measures will be carefully chosen to properly assess the difference in the     treatment (protein supplementation) effect compared with the control (Dietary advice).     Investigators hypothesize that Patients receiving protein supplement (intervention group)     Compared with patient not on protein supplement (placebo group) will maintain weight loss and     other essential health parameters.   "
10591|NCT03147443|"     Treatment based on syndrome differentiation is the essence of traditional Chinese     Medicine(TCM) and forms the individualized treatment. N-of-1 trials may be a good clinical     effect evaluation method for the individualized treatment of TCM. This study aims to compare:     (1) the efficacy of syndrome differentiation(individualized decoction) with placebo, (2)the     efficacy of syndrome differentiation(individualized decoction) with the same prescription     minus heat-clearing Chinese herbs, for patients with stable bronchiectasis through N-of-1     trials.   "
10592|NCT03147430|"     This is a non-treatment study. It will not involve the use of any investigational drug or     device. Potential participants will be enrolled through direct contact with collaborating     clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5.     The clinical Investigators or a member of their staff will conduct consent discussion once a     suspicious mammogram report is identified or if a patient is referred for imaging of a     suspicious area in the breast. After consenting the participant will be asked to donate a     blood sample, a saliva sample, medical records pertaining to the suspicious mammogram report     and a medical history questionnaire. The participants will be followed after one year to     capture progression or resolution of their suspicious mammogram report. After a biopsy     confirms the diagnosis of cancer or benign lesion, a recut sample of the tissue may be     requested for research.   "
10593|NCT03147404|"     Phase II study of avelumab in metastatic gastronetro-pancreatic (GEP) neuroendocrine     carcinoma (NEC, WHO grade 3) as second-line treatment after failing to etoposide+cisplatin:     integration of genomic analysis to identify predictive molecular subtypes   "
10594|NCT03147391|"     The study was to retrospectively analyse the efficacy and safety of LAA closure using the     LAmbre in our center from April 2014 to November 2015.   "
10595|NCT03147378|"     This study aims to evaluate the effect of food on the pharmacokinetics of ModraDoc006 in     combination with ritonavir, in an open-label, cross-over design. Patients will be randomized     into two treatment groups receiving ModraDoc006/r week 1 under fasting and week 2 under fed     condition, or vice versa.   "
10596|NCT03147365|"     -  To compare between modified strength training program and aerobic exercises on quality          of life on children with Acute Lymphoblastic Leukemia.        -  To compare between modified strength training program and aerobic exercises on          functional capacity on children with Acute Lymphoblastic Leukemia.   "
10597|NCT03147352|"     The investigators will analyze biomarkers related to the prognosis and treatment of     necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial     and immune system biomarkers can function as markers of disease severity, mortality as well     as the effects of hyperbaric oxygen therapy (HBOT). Biomarkers will be measured upon     admission to an intensive care unit at Copenhagen University Hospital and during the     following 3 days.   "
10598|NCT03147339|"     To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on     glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects     with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy     diet and no changing in physical activity pattern.Parameters related to metabolic syndrome,     anthropocentric factors, oxidative stress(Malondialdehyde), CML(AGEs factor in blood) and     systemic inflammation factors (hs-CRP وTNF-α ) will be measured at the baseline and at the     end of the study.   "
10599|NCT03147326|"     The purpose of this study is to compare the current standard whole-body x-ray with the     advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of     myeloma bone lesions.   "
10600|NCT03147313|"     This study evaluates the impact of extracorporeal shock wave treatment after microsurgical     coaptation of finger nerves. Participants will be randomized into two treatment groups with     different settings and a sham group. The participants will thereafter followed-up in a     prospective, double-blind study design.   "
10601|NCT03147300|"     POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In     Sweden, primary care professionals require an evidenced based model of care for LBP.      INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care     for LBP.      CONTROL: Current routine practice for LBP care before implementation of the BetterBack model     of care.      OUTCOME: Patient reported measures (function, activity, health), therapist reported measures     (diagnosis, intervention, specialist referral, best practice self-confidence, determinants of     implementation) and cost-effectiveness.      AIM: To deliver best practice recommendations for LBP and study their most effective     implementation through the BetterBack model of care.      METHOD: A cluster randomised trial with dog leg design. The hypothesis is that the BetterBack     model of care will result in significantly better patient and therapist outcomes as well as     cost-effectiveness compared to current routine care.   "
10602|NCT03147287|"     This research study is studying three combinations of drugs as treatments for breast cancer.      The drugs involved in this study are:        -  Fulvestrant        -  Fulvestrant with Palbociclib        -  Fulvestrant with Palbociclib and Avelumab   "
10606|NCT03147235|"     This will be a prospective, randomized controlled trial with patients randomly assigned to     either the experimental or control group. The experimental group will be exposed to the     independent variable (IV) and the control group will not be exposed to the IV. The IV will be     a music therapist- designed listening program during surgery. A total of 60 patients will be     consecutively enrolled and undergo block randomization to either a music listening group or a     control group (no music). Trained medical research personnel will assist with various parts     of the study and will be defined as those individuals who have completed and are up-to-date     on the Collaborative Institutional Training Initiative (CITI) training. These individuals     will consist of a board certified music therapist, practicing ophthalmologists, and     physicians-in-training.   "
10607|NCT03147222|"     This pilot study will evaluate the feasibility of implementing an intervention in the home     setting that is specifically designed to coach and mentor caregivers as they assist     individuals with Alzheimer's disease and related dementia (ADRD) who have fractured a hip to     perform everyday activities and engage in more physical activity.   "
10608|NCT03147209|"     Truckers face many unique challenges in their work that may adversely impact their health,     including time constraints, sedentary job tasks, and a 'moving-workplace' environment with     associated limitations to access healthy food and safe places to be physically active. These     issues make it difficult to form and maintain healthy lifestyle habits and contribute to the     high prevalence of injuries from both crashes and falls among truckers is supported by an     increase in obesity among truckers with longer durations of employment.      The investigators propose to develop and pilot test the Exercise Intervention of the Worksite     Health, Eating and Exercising for the Long-haul (WHEEL)'s weight loss intervention. This     pilot exercise intervention is aimed at achieving meaningful improvement in grip strength,     balance, and gait over 6 weeks. The investigators will use pilot sample of 15 obese (BMI ≥ 30     kg/m2) truckers, documenting changes in these measures. Individualized assessments will be     utilized. The investigators will aim to complete the following:        1. Evaluate the feasibility of the PIE WHEEL intervention for CMV drivers will result in          greater strength comparing baseline with 6 week outcomes.             1. Determine the extent to which drivers will participate in PIE WHEEL             2. Determine the extent of change in strength, balance and gait realized by PIE WHEEL               participation        2. Evaluate safety events (crashes, near misses, falls) in the week prior to PIE WHEEL and          the final week of PIE WHEEL a. Solicit driver perceptions of their own safety of ingress          and egress related to PIE WHEEL participation   "
10609|NCT03147196|"     This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in     treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as     bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the     body.   "
10610|NCT03147183|"     Renal transplant candidates who have CMV-specific, CD8+ T-cells, are CMV-seropositive and     carry HLA-A1 and/ or HLA- A2 alleles have a high probability to maintain this type of     immunity during the three first months after the transplant, despite induction     immunosuppressive therapy (thymoglobulin).   "
10611|NCT03147170|"     The investigators are proposing that individuals with elevated levels of NT-proBNP are     resistant to natriuretic peptides and are unable to handle sodium loads and maintain optimal     blood pressure values.The investigators will test this hypothesis by comparing the blood     pressure response to low and high salt diets in individuals with pre- or hypertension and who     have normal or elevated levels of NT-proBNP. The investigators expect that blood pressure     values in those with normal levels of NT-proBNP will not change with high salt diets,     whereas, in those with elevated levels of NT-proBNP, blood pressure values will increase     significantly when exposed to high salt diets.   "
10612|NCT03147157|"     The aim of this research is to design a randomized controlled clinical study, which is based     on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of     tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD     and rejection reaction will be observed, and the occurrence time and degree of adverse     reactions caused by immune inhibitors will be identified. In the meantime, providing a     possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.   "
10613|NCT03147144|"     The aim of this study is to prospectively examine the relationship of the uterine junctional     zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment     outcome. The study hypothesis is that the uterine junctional zones of women who did not     achieve pregnancy will be thicker than those of the women who do achieve pregnancy   "
10614|NCT03147131|"     The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the     proximal femur after implantation of the Fitmore compared to the CLS stem.   "
10615|NCT03147118|"     The objective of this study is to evaluate the accuracy of trapeziometacarpal injections     using palpation alone. The importance of this study is one of education, cost containment,     and decreased risk to the patient. If it can be shown that the accuracy of trapeziometacarpal     injections using palpation alone is similar to the reported accuracy of ultrasound and     fluoroscopy, then these guided techniques may not be needed.   "
10616|NCT03147105|"     Chronic progressive multiple sclerosis patients will be randomised to home-based arm     ergometry training for 12 weeks or a waitlist control group which will have access to the     treatment after 12 weeks when primary endpoint assessment has been obtained. Assessments     include clinical outcomes and questionnaires as well MRI imaging and transcranial magnetic     stimulation paradigms. Primary endpoint will be the 6 minute walking test at week 12.   "
10630|NCT03146923|"     Based on new evidence renal dietitians in Ireland are revising the diet sheet that is used to     teach patients about reducing blood phosphate. Changes that renal dietitians plan to make to     the dietary phosphorus prescription        -  Inclusion of some nuts and pulses        -  More detailed education re phosphate additives        -  More accurate protein prescription        -  Inclusion of more whole grains        -  Encouraging the use of foods with a low phosphorus to protein ratio      The investigators want to test the two diet prescription to find out, which one is better at     reducing blood phosphate and which one is more acceptable to patients. The investigators also     want to make sure it is safe.   "
10631|NCT03146910|"     Research project in which biological material is sampled and health-related medical data is     collected. In addition, already existing health-related medical data are used for further     research. Coded data are used.   "
10617|NCT03147092|"     Background Hypertension is the main risk factor for most cardiovascular diseases. Blood     pressure (BP) control has been shown to reduce the incidence of stroke, myocardial     infarction, renal diseases and heart failure. Although BP lowering is effective, few     population programs can achieve BP control. A coordinated and organized system from the     Brazilian Ministry of Healthy involving Family Health Strategy (FHS), a program for the     prevention of chronic disease, and the Popular Pharmacy Program (PPP), which subsidizes     medications for the population, could allow an earlier identification and better BP control.     Matão Controlling Hypertension (MatCH) is a community-based population project that aims to     apply an organized, integrated and coordinated program in the city of Matão, Brazil,     involving FSH and PPP in order to actively search, treat and follow-up hypertensive subjects.      Method This is a population community-based, prospective, interventional, follow-up study     where all subjects aged ≥ 40 years assisted by the FHS program in Matão will have BP assessed     monthly by trained Community Health Agents (CHA) during a domiciliary visit. Identified     hypertensive subjects will be referred to FHS physicians for nonpharmacological and     pharmacological treatment. Most of the hypertensive drugs used will be available thought the     PPP. Prevalence of hypertension, awareness, demographics and risk factors will be correlated     with BP control. The population study is expected to involve approximately 15,000 subjects.     The study period will be four years.      Discussion Considering that hypertension is asymptomatic in most cases, to reduce the     population burden of BP-related deaths and diseases it is essential to detect and treat early     all hypertensive patients. If BP control be achieved on a large scale, this program can be     applied to other populations from developing countries.   "
10618|NCT03147079|"     The purpose of this study is to determine whether a behavioural intervention focusing on diet     and physical activity is cost-effective in decreasing weight gain during pregnancy among     pregnant women with body mass index above 30, and has effect on the weight of offspring at     birth and at 2.5 years of age   "
10619|NCT03147066|"     This study evaluates the efficacy of dezocine in preventing the catheter-related bladder     discomfort (CRBD) in a postanesthesia care unit (PACU).   "
10620|NCT03147053|"     To explore the efficacy and safety of Jiedu Tongluo granules for post stroke depression. A     randomized, double-blind, placebo-controlled clinical trial was designed. The treatment group     was administered the Jiedu Tongluo granules, while the control group was administered the     placebo.   "
10621|NCT03147040|"     This is a single arm multicenter non-randomized phase II trial testing the efficacy of the     combination of carboplatin plus atezolizumab in metastatic ILC   "
10622|NCT03147027|"     Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter     ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease     (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter     ablation in patients with nonsustained VT has been not yet clarified. The incidence of     appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients     with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can     result in the prognostic improvement.To suppress ventricular arrhythmias aside from     antiarrhythmic agents, catheter ablation has been developed prominently in this decade along     with the technological improvement such as irrigated ablation catheters, three-dimensional     mapping systems, multi-polar catheters, and image integration system with CT and MRI. The     rationale of this trial is to study the efficacy of the eradication of arrhythmogenic     substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of     the occurrence of sustained VT/VF and ICD therapies.   "
10623|NCT03147014|"     Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease   "
10624|NCT03147001|"     A randomized interventions study using a crossover design. Ten well trained triathletes or     bikeriders will be included for to undergo two trail separated by about 3 weeks. The night     before the trail each subject will performe a high intense interval trainings session on an     ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The     subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the     morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject     will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike     ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0,     60 and 180 min after the training session biopsies are collected.   "
10625|NCT03146988|"     Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate     the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as     a single subcutaneous injection in healthy adult subjects.   "
10626|NCT03146975|"     Human immune system produces many different factors, which will influence health-disease     statuses. This partially explains why under similar conditions only some people become sick.     Therefore, specific analyses of such factors in healthy and diseased patients are crucial for     a better knowledge about diseases development and successful treatments. Human beta defensins     (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high     levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of     infections associated with diabetic wounds. This study will evaluate if treatment of the most     common gum disease in adults influences production of beta defensins by gingiva. Also,     clinical improvements and treatment effects on blood glycemic levels will be monitored     throughout a 2-month period. Patients with or without gum diseases and with or without     diabetes mellitus will be able to participate. After a complete oral examination to determine     periodontal status, gingival fluid samples will be collected using paper strips. These     samples will be collected before and also two-months after oral treatment and will be     analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In     weekly sections, one trained specialist will performed treatment of gum diseases under local     anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would     be lower in the presence of periodontal disease when compared to a healthy periodontal     condition; b) diabetes would influence production of these immune protective factors; and c)     treatment would provide a greater beneficial amount of defensins.   "
10627|NCT03146962|"     This is a single arm, 2-cohort, open-label trial of high dose Vitamin C intravenous infusion     in subjects with solid tumor malignancies who are eligible for resection (cohort A) or with     KRAS or BRAF mutant metastatic cancer who have received prior systemic treatment (cohort B).   "
10628|NCT03146949|"     This study compares two oxygenators commonly in use to establish whether they effect the     amount of isoflurane in the patient's blood. Half of the patients will be placed in a group     using the Sorin Inspire oxygenator and half into the group using the Medtronic Affinity     Fusion oxygenator.   "
18675|NCT03041116|"     This study will investigate whether fosmetpantotenate (RE-024), a phosphopantothenate     replacement therapy, is safe and effective in treating patients with Pantothenate     Kinase-Associated Neurodegeneration (PKAN).   "
10632|NCT03146897|"     The research seeks to determine the relative effectiveness and cost effectiveness of     alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in     normal program settings. The results of this study will guide decisions about what     commodities to use in supplementary feeding programs in particular contexts and populations,     and what factors need to be addressed to ensure maximum effectiveness in the treatment of     moderate malnutrition.      Tufts University, Washington University in St. Louis, School of Medicine, Sierra Leone     Ministry of Health and Sanitation (MoSH), Project Peanut Butter, Caritas Bo, World Food     Programme (WFP), and the United States Agency for International Development (USAID) are     collaborating to conduct an assessment of the effectiveness, cost, and cost-effectiveness of     food aid commodities in treating moderate acute malnutrition (MAM) in young children. The     study comparison is based on a targeted food delivery to children 6-59 months who are     screened for MAM. Study participants will receive one of four approximately isoenergetic test     foods:        1. Super Cereal Plus (SC+) with amylase        2. Corn-soy Blend Plus (CSB+) and oil        3. Corn-soy Whey Blend (CSWB) and oil (CSWB is a new product which is a modified version of          CSB)        4. Ready-to-use Supplementary Food (RUSF, lipid-based)   "
10633|NCT03146884|"     Research project in which biological material is sampled and health-related personal data is     further used and collected.      Coded data are used.   "
10634|NCT03146871|"     This trial studies the side effects of recombinant EphB4-HSA fusion protein when given     together with azacitidine or decitabine in treating patients with myelodysplastic syndrome,     chronic myelomonocytic leukemia, or acute myeloid leukemia that has come back or has not     responded to previous treatment with a hypomethylating agent. Recombinant EphB4-HSA fusion     protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Hypomethylating agents, such as azacitidine and decitabine, slow down genes that     promote cell growth and can kill cells that are dividing rapidly. Giving recombinant     EphB4-HSA fusion protein together with azacitidine or decitabine may work better in treating     patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid     leukemia.   "
10635|NCT03146858|"     Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary     arteries). When complete blockage of one of the arteries occurs, emergency treatment to     unblock the affected artery and rescue the heart muscle at risk is essential. This is usually     achieved by performing an emergency procedure called primary percutaneous coronary     intervention (PPCI).      Anticlotting treatment is also necessary to reduce the chances of further heart attacks. As     part of standard care, tablets that target small cells called platelets (central to blood     clot formation) are given as soon as an acute heart attack is suspected. These tablets     include aspirin and ticagrelor/prasufrel. Although both ticgrelor and prasugrel are     effective, the onset of action is delayed by up to 8 hours when given in context of an acute     heart attack. This delay in onset of action can increase the risk of further heart attacks.      Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known     as coagulation cascade. Enoxaparin or an alternative is recommended as a single does to     support the PPCI procedure. The effects of a single shot of enoxaparin do not last long     enough to bridge the gap in anticlotting treatment caused by the delayed action of     ticagrelor/prasugrel. Since the investigators have realised the delayed onset of action of     tablet therapy, the investigators have been using another drug called tirofiban as a drip.     Tirofiban blocks platelets effectively, but greatly increases the risk of bleeding events.      The investigators believe that giving enoxaparin as a drip for 3-6 hours (following the     single dose) instead of tirofiban, would be sufficient to bridge the gap in anticlotting     effect without greatly increasing the risk of bleeding. This is a pilot study to assess the     effects of enoxaparin drip in patients presenting with acute heart attacks and undergoing     emergency treatment with PPCI.   "
10636|NCT03146845|"     Some wounds are very slow to heal. Keeping moisture at the right level in a wound is very     important, so wounds are almost always kept covered while they are healing. There are many     different dressings that can be used to cover a wound. These dressings have different     capabilities in handling the fluid that comes out of a wound. Some dressings can only be worn     for a few days, while others may be worn up to 7 days. Dressings with short wear times may     require more visits to the doctor's office for changes, while dressings with a longer wear     time may mean fewer visits to doctor's office.      Allevyn Life Non-Bordered is a new 4 layer dressing intended to cover wounds that have     moderate to heavy fluid secretion. Allevyn Life Non-Bordered can be left on a wound for up to     7 days.      This study will evaluate subject satisfaction with the dressing when used on a wound.   "
10637|NCT03146832|"     The goal of the present study is to compare different therapeutic strategies (according to     habituation model vs. according to the inhibitory learning approach) during exposure to     thermal pain in an experimental design.   "
10638|NCT03146819|"     This study is designed to compare outcome data for patients who have recently undergone     surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter     referred to as the iTotal) versus those who have undergone surgery with Off-the-Shelf (OTS)     systems.   "
10639|NCT03146806|"     The main purpose of this study is to determine the safety, feasibility, and utility of     intranasal (NAS) ketamine in persistent uncontrolled cancer related pain. In this prospective     clinical trial the researchers will investigate the use of NAS ketamine in patients with pain     related to cancer or cancer treatment. The researchers plan to enroll at least 15 patients     meeting inclusion/exclusion criteria, to achieve a minimum of 10 patients who complete the     study. Participants will be recruited from the supportive oncology clinic, oncology clinics,     the pain clinic and Acute Pain Service at Emory. Participants will be asked to return to the     Phase I unit of the Winship Cancer Building C for a total of 5 study visits, each two to five     days apart. During these visits participants will complete questionnaires, have blood samples     drawn and will have study medication administered to them in escalating doses. For safety     monitoring participants will be contacted by telephone 14 days after the last dose of     medication administered.   "
10640|NCT03146793|"     The national drug safety agency authorizes nominatively the use of sodium thiosulfate in     dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600     patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at     6 months including mortality. Early use improves effectiveness.   "
10641|NCT03146780|"     This study aims to compare how a single cap best fit on a tooth that is fabricated with     digital and conventional impression techniques.   "
10642|NCT03146767|"     The staircase phenomenon could have repercussions on the onset and recovery time following     administration of a neuromuscular blocking agent. The investigators aim to assess the     magnitude of the staircase phenomenon and its impact on various aspects of neuromuscular     blockade with a randomized controlled double blind trial.   "
14227|NCT03099239|"     The purpose of this Phase 1 study is to determine the safety of one, two, and three     intravenous infusions of human umbilical cord tissue-derived mesenchymal stromal cells     (hCT-MSC), administered every two months, in children with autism spectrum disorder (ASD).   "
10645|NCT03146728|"     There are over 44,000 persons living with spinal cord injury (SCI) in Canada, who face     substantial challenges in maintaining a healthy body composition after injury. As a result,     obesity, diabetes and cardiovascular disease are prevalent in this population. Guidelines     indicating that twice weekly 20-minute sessions of exercise (plus resistance training) will     increase physical fitness in those with SCI have been recently published. However, no     SCI-specific guidelines indicating the volume of exercise to reduce the risk of developing     obesity-related diseases exist. Longitudinal studies indicate that a weekly exercise-related     energy expenditure of 2000 - 2500 Calories is correlated with the least likelihood of     cardiovascular disease in the able-bodied population. There is little information regarding     energy expenditure (EE) for activities carried out by persons with SCI, with less available     for persons with tetraplegia. Once known, this EE data can be used to develop exercise     interventions to determine the volume of voluntary exercise required to reduce obesity and     risk factors for diabetes and cardiovascular disease in those living with tetraplegia.   "
10646|NCT03146715|"     Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks     significantly increased skin carotenoid levels as compared to children who consumed a placebo     juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy     breakfast food alternative, was developed by Utah State University researchers.      Objective: To determine the effect and response of a carotenoid-rich baked product on change     in skin carotenoid levels among children.      Design: A six week randomized controlled trial. Participants/setting: Participants were     children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention:     Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid     baked food or control (n=25) who consumed a baked food with no carotenoids. Children were     asked to eat the designated portion of the assigned food once a day for six weeks. Skin     carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in     Raman intensity counts. Participants were asked to maintain their diet and completed a food     frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were     returned to clinic, counted, and recorded.      Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6     weeks.      Statistical analysis performed: Repeated-measures ANOVA was used to assess the group     differences in Raman counts.   "
10647|NCT03146702|"     Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined     as an increase in mean pulmonary artery pressure ≥25 mmHg when measured at rest. PH often     progresses to heart failure and premature deaths. PH is a progressive disease that has many     causes, which can affect people of all ages, is characterized by shortness of breath, reduced     exercise tolerance, psychological distress and tiredness and reduced quality of life. Surveys     of SF-36, 'Nottingham Health Profiles' and 'Minnesota Life with Heart Failure' surveys are     routinely performed in PH clinically. However, none of the questionnaires are specific to     pulmonary hypertension, so they are incomplete in determining the condition of the disease     and the patients. There is no Turkish questionnaire for patients with pulmonary hypertension     and other surveys used are inadequate in determining the condition of the patient and the     patient since they are not specific to the disease. The aim is to provide a Turkish     questionnaire that is specific to pulmonary hypertension in the literature.   "
10648|NCT03146689|"     Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin     are effective in osteoarthritis (OA), it is still unclear why they work for some people but     not others. The investigators are undertaking an individual patient data (IPD) meta-analysis     to identify responders according to patient characteristics, however, no studies report the     presence of synovial hypertrophy or neuropathic-like pain. These two traits are of interest     as they may be used to optimise the treatment effects of the two drugs which work via     different mechanisms to reduce pain in OA. The investigators are therefore conducting this     pilot n-of-1 trial series.      This pilot n-of-1 trial series will investigate whether a person with OA, who has a different     balance between inflammatory and neuropathic pain, shows a preference between these     mechanistically different treatments. The trial will also be used to offer recommendations on     the use of n-of-1 trial series for individualised (precision) medicine in OA.   "
10649|NCT03146676|"     Analysis of Gene expression and microbiome profiling in hidradenitis suppurativa to identify     immunological biomarkers of disease activity.   "
10650|NCT03146494|"     A total of 300 consecutive cardiac patients will receive preoperative thyroid function     profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD)     and 150 normal human.For one thing, we will compare the two groups and study the role of     thyroid function in the develoment of STAAD. For another, we will collect all the     perioperative data of the STAAD group and study the role of thyroid function in the prognosis     of STAAD.   "
10651|NCT03146481|"     The aim of this randomized, double-blinded, controlled study is to evaluate the effect of     pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2%     Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible     pulpitis.   "
10652|NCT03146468|"     This is a prospective study of the safety and efficacy of nivolumab for the treatment of     relapsed or residual haematological malignancies after allogeneic stem cell transplantation     (alloSCT).      Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The     primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD     following nivolumab treatment post-alloSCT.   "
10653|NCT03146455|"     The purpose of this study was to establish the normal reference range of Thrombelastogram     parameters in Hunan by a multicenter study, and to analyze the specificity of     Thrombelastogram detection and the influence of gender, age and blood type on     Thrombelastogram. The study will provide basic data and statistical basis for the     establishment of normal reference range of Thrombelastogram in Hunan.   "
10681|NCT03146091|"     Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional     management includes inpatient administration of either oral or intravenous antibiotics with     resumption of oral intake as symptoms improve. Recent literature has however questioned both     inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are     associated with non-negligible risks to patients. The aim of this trial is to assess the     feasibility of a randomized controlled trial designed to determine whether nonantibiotic     treatment of uncomplicated diverticulitis is safe in the outpatient setting.   "
10654|NCT03146442|"     Adolescent obesity, negatively affecting the lives of over 18 million (34%) US adolescents,     continues to be a major public health concern due to the increased risk of developing chronic     diseases, including type 2 diabetes. Thus, there is a great need to develop effective,     dietary strategies that target health outcomes, including weight management and glycemic     control in young people. One particular strategy that is gaining scientific support includes     the daily consumption of a protein-rich breakfast. This study will identify the potential     role of protein at breakfast as a key component of a healthy diet for improvements in     appetite control, satiety, and weight management to reverse the obesity epidemic and prevent     and/or delay serious health complications in young people.   "
10655|NCT03146429|"     This is the re-analyzing study of observational study by Parkinson's Progression Markers     Initiative   "
10656|NCT03146416|"     The primary objective of the study is to compare the safety and tolerability of multiple     subcutaneous (SC) or intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian     subjects.   "
10657|NCT03146403|"     The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces     the number of days that subjects have a genital herpes recurrence. Other purposes of the     study are to 1) see how safe and tolerable a maintenance dose is, and 2) to see if a     maintenance dose of GEN-003 reduces the number of days that the herpes simplex virus type 2     (HSV-2) is found in the genital area (viral shedding).   "
10658|NCT03146390|"     The Essential oils (EO) are composed by a wide diversity of products. Therefore, their     antimicrobial activity will be related to their composition, configuration, amount and their     possible interaction. The traditional formulation containing EO (T-EO) is a complex mixture     of phenolic compounds combined with determinate EO: 0.092% of eucalyptol, 0.064% of thymol,     0.06% of methyl-salicylate and y 0.042% of menthol. All of this solved in a hydroalcoholic     vehicle containing from a 21.6% to a 26.9% of alcohol. Thus, T-EO contain ethanol, which is a     chemical compound used in order to dissolve and stabilize the numerous substances present in     the rinse. The concentration of ethanol present in the T-EO rinses, as previously said, is     more than 20%. This concentration of ethanol, higher than 20%, is been found sufficient to     dissolve the EO but insufficient to have a direct antibacterial effect. In fact, the     manufacturer presents the alcohol contain (21.6%), among others, as an inactive ingredient in     its formula. Over the years, the adequacy of the use of ethanol in mouthwashes, as well as     their effects on the surfaces of composite restorations and their possible role in     development of oropharyngeal cancer have been discussed. Although a direct cause-and-effect     correlation between the development of oropharyngeal carcinoma and the use of alcohol-based     rinses has not been demonstrated and probably it will never be (at least by epidemiological     studies), it is considered desirable to eliminate ethanol from daily mouthwashes, especially     for those patients at higher risk. Furthermore, the fact that the alcohol is present in its     formula, have produced that some clinical practitioners do not prescribe the traditional     formula due to the controversy of the issue. All this have lead to the development of new,     alcohol free formulations of EO (Af-EO).      The composition of the Af-EO is exactly the same in their active ingredients (Eucalyptol,     Thymol, Methyl-salycilate and Menthol), but sodium fluoride has been added. Some differences     are found in their inactive ingredients. These are based on the alcohol containing of the     T-EO, without presence in the Af-EO and the presence of Propylene Glycol, sodium lauryl     sulfate and sucralose in the Af-EO, without presence in the T-EO.      In order to measure the efficacy of a mouthwash against the dental plaque two different     concepts should be defined: the substantivity and antiplaque effect. The substantivity of an     oral antiseptic is defined as the prolonged adherence to the oral surfaces and its slow     release at effective doses which guarantee the persistence of the antimicrobial activity. The     more substantivity an oral antiseptic has the better. For its study in vivo, the most popular     models are those which analyze the effect that a single mouthwash has in a mature biofilm.      The second aspect that should be studied from an oral antiseptic, the antiplaque effect, is     defined as the capacity that an agent has to avoid the formation of bacterial aggregates     (plaque) on the oral surfaces. For its study in vivo, models start from a baseline sample     with levels of plaque near to 0 in order to assess the power of the antiseptic to reduce the     formation of bacterial plaque (normally dental plaque) against the control. A clinical study     of 6 months using a determinate antiplaque agent is necessary in order to tag an antiseptic     as effective. However, in the literature, there is an established model of 4 days of plaque     regrowing which can assess the inhibitory activity that the mouthwashes have per se;     furthermore, it determines the relative efficacy of the different formulations being     considered as predictable of the antiplaque effect of an antiseptic.      In addition, another important factor in the study in vivo of an oral antiseptic is the     necessity to conserve intact the oral biofilm at all stages: formation, recollection and     analysis of the oral samples. This is in order not to interfere the delicate three     dimensional structure of the oral biofilm which has been proven to be essential in the     resistance to the effects of an external antiseptic agent. For these reasons, the study of     the oral biofilm with the help of intraoral disks hold in specially designed apparatus     combined with the application of the Confocal Laser Scanning Microscopy have proved to be     very valuable at the study of the oral biofilm in its intact hydrated natural state.      Since an alcohol free formulation of the EO have come up to the market, it seems convenient     to compare its effects to the traditional one. Although some studies comparing the effects of     T-EO and Af-EO have been found, none of them assessed and compared their substantivity and     antiplaque effect in an in vivo model of structured oral biofilm. For this reason, the aim of     the present study was to compare the in vivo antibacterial effect (immediate effect,     substantivity and antiplaque effect) of the EO with and without alcohol in structured oral     biofilm.   "
10659|NCT03146377|"     This is an open-label, single centre, single-arm phase II study which aims to assess the     efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan     (Xeloxiri regimen) in treating patients with refractory metastatic colorectal cancer.     Clinical data from patients diagnosed with colorectal cancer will be collected and analyzed     in this study. The patients' data will be collected and maintained in the Division of medical     oncology of the Department of Medicine, Queen Mary Hospital.   "
10660|NCT03146364|"     This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55,     20 of which hospitalized in mental health department and 20 in medical follow-up.      Different test will be administered, in two or three sessions, to evaluate cognitive ability,     function ability and participation.      The results of the VIS shopping task performance (statically & dynamically) and its     correlation with the cognitive and function tests as well as the participation questionnaire     will be examined. These findings will indicate whether the shopping task is valid to assess     executive functions for people with schizophrenia and whether it is ecologically valid.   "
10661|NCT03146351|"     Infant born preterm have an increased risk of adverse long-term developmental outcomes.The     risk associated with preterm birth increase as gestational age decreases, and vulnerability     remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). There are     many studies in the literature showed that the prevalence of developmental delay increases     with premature birth. However, there is no study in the literature investigates effect of     early intervention program motor performance in subgroups of preterm infants. Hence the aim     of this study is to evaluate the differences in effects of early intervention program on     motor development in early and moderate (<34 weeks) and late preterm infants.   "
10662|NCT03146338|"     Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab,     have become standards in the management of metastatic colorectal and head and neck cancers.     These therapies are used in daily practice, that requiring to manage their skin and digestive     toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often     neglected and under-treated.      Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is     often underestimated because they are difficult to identify and accountable by clinicians in     the context of cancer under chemotherapy.      There is currently no national or international recommendation on the management of     hypomagnesaemia in oncology and medicine in general. There are, however, on the market many     nutritional supplements rich in magnesium in the form of tablets or oral solution, in     multiple dosages.      These food supplements rich in magnesium are sold without proof of effectiveness. Moreover,     the prescription of oral magnesium supplementation adds to the oncology patient an     over-medicalization, which can be poorly tolerated at the digestive level, and responsible     for diarrhea and a lack of compliance.      The European Food Safety Authority (EFSA) recommends in its opinion on Dietary reference     values for water to consume 2 liters for women and 2.5 liters for men every day, all sources     combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5     Liter per day excluding food. However, there are multiple water marketed or distributed     freely, with different compositions. Thus the quantity and quality of the mineral water     consumed can influence the metabolism. Rozana® mineral water, has the double advantage of     being the French water the most concentrated in magnesium (160 mg / L) and of being lowly     concentrated in sulphate, responsible of the laxative power of certain waters.      Instead of adding magnesium supplements with a poor digestive tolerance, to patients with     metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate     whether a change in oral hydration in quantitative and qualitative terms can decrease the     rate of hypomagnesemia in patients treated with anti-EGFR.   "
10663|NCT03146325|"     This study is an etiologic trial to test the hypothesis that predicts that Helicobacter     pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body     iron. The study will assign and aims to complete the follow-up of 240 subjects half of them     assigned to a highly effective FDA approved 14-day course of a 3-1 capsule containing bismuth     subcitrate, metronidazole and tetracycline plus omeprazole which is now OTC. We have tested     the effectiveness of this therapy in the study population and it seems to yield almost 100%     eradication on PP analysis. We need the best possible, near 100% eradication rate, which we     have already obtained in a pilot, to make comparisons on ITT basis and safely conclude that H     pylori leads to a deficit of body iron.   "
10664|NCT03146312|"     This is a global transcriptomics and epigenetic pilot study designed to identify changes in     gene expression and DNA methylation patterns following the consumption of an     MVM/phytochemical supplement in a small group of healthy subjects. We hypothesize that     genome-wide transcriptional and epigenetic studies will elucidate the molecular mechanisms     underlying the health benefits associated with MVM/phytochemical supplementation.   "
10682|NCT03146078|"     The overall goal of this project is to characterize the natural history of disease     progression in patients with USH2A related retinal degeneration associated with congenital     hearing loss (Usher syndrome type 2a) or non-syndromic retinitis pigmentosa (RP39).   "
10683|NCT03146065|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of     PF-06730512 in healthy subjects.   "
11979|NCT03129100|"     The purpose of this study is to evaluate, in participants having achieved a state of     sustained remission, if the ixekizumab treatment groups are superior to the placebo group in     maintaining response during the randomized withdrawal-retreatment period in participants with     axial spondyloarthritis.   "
10665|NCT03146299|"     Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic     surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer     complications and shorter hospitalization compared to total abdominal hysterectomy.      However, the hysterectomy for giant uterus has the difficulty of delivering the uterus out of     the body. According to the results of TLH, LAVH and abdominal hysterectomy, TLH and LAVH show     the postoperative complications were less frequent (3) and the postoperative recovery (4) and     return to daily life were faster than total abdominal hysterectomy (3) even if it took longer     operation time.      Therefore, laparoscopic hysterectomy has many advantages over abdominal hysterectomy and     indications are increasing. However, there has not yet been a direct comparison between TLH     and VALH for large uterine surgery. In this study, we compared the results including the     complications, hospitalization period and so on., in undergoing operation and post-operation     between TLH and LAVH for the removal of giant uterus, which is predicted to be over 500 g.   "
10666|NCT03146286|"     The aim of the study will investigate whether impairment in the action of insulin to promote     the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a     liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new     protein in response to dietary protein intake, which ultimately may compromise maintenance of     muscle size and quality of life.   "
10667|NCT03146273|"     This clinical study is designed to evaluate difference in the AUC of the absorption of     Multivitamin and minerals defined in the protocol   "
10668|NCT03146260|"     Azoospermia is complete absence of sperm in the ejaculate. It accounts for 10-15% of male     infertility cases. It is classified as obstructive and non-obstructive azoospermia (NOA). NOA     constitutes 60% of all cases of azoospermia. Testicular sperm extraction (TESE) for     intracytoplas¬mic sperm injection (ICSI) was first introduced for treatment of obstructive     azoospermia in 1993. Soon afterwards testicular sperm were retrieved successfully and used in     ICSI in cases of NOA. In the NOA cases, TESE combined with ICSI has been proven to be an     acceptable line of treatment. Microdissection TESE may have some theoretical benefits over     conventional TESE, but uncertainty exists about its superiority. During a conventional TESE     procedure, the testis is exposed through a small incision and one or multiple biopsies are     taken blindly. Micro TESE was first introduced in 1999. In this technique, the tunica     albuginea is widely opened and examination of the testicular tissue is carried out at 20-25×     magnification under an operating microscope allowing visualization of whitish, larger and     more opaque tubuli. The concept of this technique is that these tubuli are more likely to     contain active spermatogenesis. also no secure clinical predictors of (SR) are demonstrated     for both procedures.The recovery of spermatozoa is successful in only 50% of cases and     therefore the ability to predict those patients with a high probability of achieving a     successful sperm retrieval would be of great value in counselling the patient and his partner     . There is no single clinical finding or investigation that can accurately predict the     outcome of TESE.An unsuccessful sperm recovery has important emotional and financial     implications so objective counselling based on predictive factors may offer realistic     expectations for both the couple and physician.   "
10669|NCT03146247|"     This study aims to identify and describe the presence of itch active molecules in psoriasis     and response to treatment with apremilast. This data will be complemented by     immunohistochemical data determining nerve ending density and neuropeptide concentrations     before and during treatment and correlated with patient reported outcome. It is important to     underscore that itch may interfere with various aspects of patient functioning, emotions and     social status and should therefore be adequately addressed while treating patients with     psoriasis   "
10670|NCT03146234|"     This study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients     with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of     GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there     are no effective therapies known at this time.   "
10671|NCT03146221|"     The initial hypothesis of this work is that the genesis and the evolution of the atheromatous     plaque are partly controlled at the molecular level and in particular by the microRNAs     through their role as regulator of the genes.      The study of the tissue and serum profile over time of specific microRNAs involved in the     regulation of atheromatous plaque correlated with clinical data and restenosis imaging will     allow to define biological markers of restenosis in the patient with an arteritis of the     lower limbs .      This study is a pioneer in the field and it would be imprudent to conclude that a biomarker     would be used clinically at the end of this work alone. Nevertheless this study will make a     major advance in this topic, in vivo intervention studies with inhibition or over-expression     of microRNA will obviously be necessary to confirm the use of these as biomarkers of     arteritis of the lower limbs.      Regular assay of reliable biomarkers in arterial patients will ultimately suggest early     management to best adapt surgical and medical treatment.   "
10672|NCT03146208|"     Coronary artery disease is a contraction of the coronary arteries that prevent adequate blood     supply to the heart muscle is called CAD. Usually caused by atherosclerosis, it may be     advanced to the point where the heart muscle is injured due to lack of blood supply. Such     damage may result in infarction, arrhythmias, and heart failure(1,2).      Telomeres are short in circulating leucocytes in patients with coronary artery disease but     the precise mechanism is not well-known (3).      Telomere and telomerase are affected by cytomegalovirus (CMV) infection due to its effect on     increasing the number of highly differentiated T cells that are characterized by shorter     telomere length (TL) and lowered telomerase activity (TA). Both genetic and environmental     factors have been connected with individual distinction in TL.Cardiovascular risk factors     such as smoking, diabetes mellitus, hypertension, obesity, and stress have been considered to     upsurge inflammation, oxidative stress, therefore accelerating TL shortening (1,2)      It has also been observed that telomere loss in type 2 diabetic patients contributes to     oxidative stress and endoplasmic reticulum stress while telomere shortening has also been     proposed that it can serve as an independent risk factor of T2DM and it can measure disease     progression(4).      Moreover, telomeric length in peripheral blood mononuclear cells (PBMCs) is associated with     the duration of disease and good glycemic control seems to be protective for telomeric loss     (5).      Growth differentiation factor-15 (GDF-15) is a member of the transforming growth factor     (TGF)-β superfamily. GDF-15, recently identified as one of the new cardioprotective     cytokines. It is highly expressed in cardiomyocytes, adipocytes, macrophages, endothelial     cells, and vascular smooth muscle cells in normal and pathological condition. GDF-15     increases during tissue injury and inflammatory states and is associated with cardiometabolic     risk(6).      Dipeptidyl peptidase inhibitors (DPP4 -I) are called gliptins which increase the incretin     levels and therefore prolong the post-prandial insulin action(7).      Diana et al reported that In type 2 diabetic patients, leukocyte telomere was significantly     shorter than control groups and was significantly elongated after intervention by     sitagliptin(8).      The common feature of all risk factors of CAD and T2DM imbalance between pro- and     anti-oxidative factors in the organism with an increased production of reactive oxygen     species (ROS).Nuclear factor erythroid-derived factor 2-related factor 2(Nrf2) is a family of     transcription factors which plays an important role in protection against CVD and DM by     regulating antioxidant enzymes in cells after ROS exposure (9).      In our study, we will propose a model, which would provide the basis to establish a marker     for chronic reactivation of CMV and shed more light into the pathophysiology of CMV infection     in patients with CAD in relation to GDF-15 and NrF2 and their implications on disease     progression. Ultimately, this would then enable us to identify patients at risk and develop     novel strategies for future treatment and prevention of heart diseases in our country. In     light of our project research, the question arises whether telomere length could represent a     marker of chronic CMV reactivation and uncertainty their length will be modified by the     effect of DPP-4 or not?   "
10684|NCT03146052|"     We aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low     morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the     procedure and 75% of the dose is given on the day before) with the standard split-dose     regimen in patients undergoing screening and surveillance colonoscopy using a low volume     bowel preparation (2L PEG-citrate-simethicone plus Bisacodyl). We enrolled consecutive     outpatients undergoing screening and surveillance colonoscopy in a randomized, single-blind,     non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split     dose regimen (1,5 L of PEG + bisacodyl the day before and 0,5 L 4 hours before colonoscopy);     group B, symmetric split dose regimen (1 L of PEG + bisacodyl the day before and 1 L 5 hours     before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing.     Moreover, all patients filled in a nurse-administered questionnaire assessing compliance,     tolerability and safety of bowel preparation.   "
10685|NCT03146039|"     The purpose of this study is to find out whether patients with cervical cancer treated with     about a new radiation technique called stereotactic body radiotherapy (SBRT) have less     stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy     radiation, metal hardware is placed through the vagina and into the uterus, which can cause     pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not     require the insertion of any metal hardware.   "
18676|NCT03041103|"     Acceptability and tolerance of a new food product in adults and children.   "
10673|NCT03146195|"     Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life     of middle aged and elderly women in non-neoplastic diseases. An aging population makes the     incidence of this disease to increase year by year. Surgical operation is the main treatment.     While the recurrence rate of classic repair surgery is high, the method of patch implantation     reinforces the supporting force, which significantly reduce the recurrence rate. However,     this method is costly and is associated with complications which may trigger new symptoms. As     such, there is still no perfect surgical method. The main reason for this is that the     assessment method of pelvic defects is crude and indirect, which results in the diagnosis of     FPOP only representing external problems whereas, inner defected parts are not properly     assessed. In recent years, research with the use of 2D and 3D MRI reconstructions on the anus     levator muscle and ligament has become a hot topic. It found that the characteristic of the     high resolution of soft tissue in the magnetic resonance imaging (MRI) has a big advantage in     pelvic floor study.The investigators commenced the study of 3D reconstruction technology     based on the MRI datasets in 2009. The investigators have mastered the most common, key     technologies of MRI three-dimensional reconstruction. The investigators have done research     targeted on the reconstruction methods of the normal pelvis, viscera, ligaments, pelvic floor     muscles. This project is aimed at 3D reconstruction of the whole pelvic base on static and     dynamic MRI images from FPOP patients, and establish the corresponding space coordinates     assessment system to do location and quantitative research of the pelvic viscera and its     support structure, thus providing a FPOP diagnosis platform that is more precise, direct and     comprehensive.   "
10674|NCT03146182|"     The purpose of this study is to determine the efficacy of C-reactive protein and     procalcitonin based guidelines versus standard of care to reduce duration of antibiotic     exposure in patients hospitalized with community acquired pneumonia.   "
10675|NCT03146169|"     In recent years, Hong Kong has been undergoing rapid changes with macro social and economic     trends. The increasingly complex and diverse family structure contribute to concerns     regarding the well-being of families in Hong Kong, including their health, happiness and     harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the     increasing needs of promoting healthy active lifestyle among Hong Kong families. In this     connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on     FAMILY Holistic Health, will be conducted in order to increase the awareness of the     importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components -     train-the-trainer program, community-based family interventions and public education events.     It is expected that trainees from the train-the-trainer program will acquire adequate skills     to organize community-based health education programs effectively. Participants of the     community-based family interventions will gain knowledge on family holistic health and live a     healthy active lifestyle. Attendees of the public education events will become more aware of     the importance of FAMILY 3Hs.   "
10676|NCT03146156|"     The objective of this proposal is to break the vicious cycle of obesity/metabolic dysfunction     during pregnancy. Lifestyle interventions in obese women during pregnancy have had limited     success in improving maternal or offspring short and long-term metabolic health. We propose     that lifestyle interventions need to be initiated prior to conception in overweight and obese     women (henceforth referred to as obese) in order to first improve maternal metabolism.     Lifestyle interventions will take place in the greater Cleveland recreational facilities.     Metabolic evaluations will be conducted in the Clinical Research Units of the Case Western     Reserve Clinical Translational Science Center (CTSC). We hypothesize this will result in     decreased fetal adiposity and improved metabolic function in the offspring.   "
10677|NCT03146143|"     study will assess the effect the ultrafiltration after pediatric congenital heart surgery on     cardiopulmonary bypass. patients will be divided into two groups. first group will receive     ultrafiltration and the second group will be control group without filtration.      we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and     duration of ventilation.   "
10678|NCT03146130|"     Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic     medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic     agonists (AD). They constitute a major public health issue due to their sometimes dramatic     socio-occupational and judicial consequences. Most often the therapeutic strategy is to     reduce or even stop AD, which can lead to withdrawal symptoms, apathy or aggravation of motor     signs.      N-acetylcysteine (NAC) may have an interest in the treatment of ICD. This molecule reduces     craving in addictions by substance abuse, but also in behavioral addictions, with as a     potential mechanism a reduction in levels of plasma alphasynuclein.      The main objective of this randomized, double-blind, placebo-controlled, multicenter     controlled trial is to demonstrate that a 10-week NAC add-on treatment, compared to placebo,     improves the behavioral addictions of Moderate in the MP. The main endpoint will be the     variation of the subdivision of the hyperdopaminergic behaviors of the Ardouin Parkinson's     Disease Behavioral Assessment (ECMP) scale between the baseline and after 10 weeks of     treatment.   "
10679|NCT03146117|"     The overall goal of this project is to investigate the diagnostic performance of integrated     F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT)     imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and     non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image     guided radiation therapy (IGRT) planning.   "
10680|NCT03146104|"     Consent will be taken from the relatives and the patient will be taken to the operating room.     Inside the operation theatre patient will be shifted to operating table and standard monitors     will be attached. The patient will then be given induction agent to make him/her unconscious     and unaware of the surrounding and muscle relaxant to prevent movement will be administered.     He/she will be intubated with appropriate size tube to maintain airway. In order to maintain     anesthesia he/ she will be given either of inhalational or intravenous anesthetic throughout     the surgery. Intracranial pressure will be measured using venflon needle as soon as burr hole     is created in the skull. Throughout the surgery patients vital parameters will be monitored     and appropriate treatment will be given in case if the vitals are not stable.   "
11980|NCT03129087|"     This study will compare the effects of vocal rest versus continuous vocalization for one hour     immediately following botulinum toxin injections for adductor spasmodic dysphonia.   "
10686|NCT03146026|"     The purpose of this study was to examine the impact of 12 weeks of combined exercise training     (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance,     and body composition in obese adolescent girls. Thirty obese adolescent girls participated in     this study. The girls were randomly divided into CET group (n=15) and control group (n=15).     The CET group performed concurrent resistance training followed by aerobic training at 40-70%     of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1,     C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance     (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio were measured before and after     the 12-weeks study.   "
10687|NCT03146013|"     The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics     HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed     screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening     assay (Avioq ELISA).   "
10688|NCT03146000|"     Postpartum perineal pain is a very common complaint. It can have negative consequences for     mother and child including disability in daily functioning for the mother; for example, it     can interfere in taking care of her infant and in breastfeeding. Early pain management is     thus relevant to provide relief and prevent chronicity.      Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective     cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the     first day after birth, of 75% in women with an intact perineum   "
10689|NCT03145987|"     The increase in life expectancy is associated with a gradual aging of the population so     creating new needs arising from this new situation. Memory ability declines with age and     memory deficits are regarded as an initial symptom of dementia of Alzheimer's Disease (AD)     type, one of the most prevalent cognitive disorders in older people. States and scientific     community have been called to find preventive strategies acting against the consequent     physiological cognitive decline with the aim to attenuate the increase of dementia. Numerous     studies have shown that polyphenolic compounds derived from multiple dietary sources, and     more specifically the polyphenolic compounds found in grapes (GP), are able to attenuate the     cognitive impairment and in reducing neuropathological lesions in the brain in experimental     animal models for the study of Alzheimer's Disease (AD) .      In recent years, several in vivo studies have shown that oral administration of polyphenols     from grapes improves antioxidant status in the brain and prevents neuronal damage induced by     free radicals. The intake of proanthocyanidins, especially in the monomeric form, showed to     produce an improvement of cognitive function in an Alzheimer's disorder animal model.      A randomized, double-blind, placebo-controlled clinical trial was designed by the     investigators with the aim to evaluate potential beneficial effects of a Vitis vinifera-based     food supplement on cognitive functioning and neuropsychological status in healthy older     adults aging 55-75 years.      For the enrollment, mental status was evaluated through the Mini-Mental State Exam, a test     able to provide quickly a screen of orientation, providing a rapid screen of recall,     language, orientation, registration, attention and calculation. 111 subjects were recruited     and, after obtaining the informed consent, successively randomly divided in two groups: Group     1, N = 57 to be treated for 12 weeks with Vitis vinifera extract (verum 250 mg/day); Group 2,     N = 54 to be treated for 12 weeks with placebo. Cognitive functioning and neuropsychological     status were evaluated at the beginning (before treatment) and a the end of treatment by using     Mini Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety     Rating Scale (HARS) and Repeatable Battery for the Assessment of Neuropsychological Status.   "
10690|NCT03145974|"     This study is an extension of the Spanish Initiative for Epidemiology, Stratification and     Therapies of Acute respiratory failure (SIESTA) Network.      The present study is aimed to establish the epidemiological characteristics and clinical     outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure     [defined as a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or     more, and FiO2 of 0.3 or more] admitted in a network of Spanish hospitals.   "
10691|NCT03145961|"     c-TRAK TN is a multi-centre phase II study, consisting of a circulating tumour DNA (ctDNA)     screening component and a therapeutic component. c-TRAK TN aims to assess whether ctDNA     screening can be used to detect residual disease following patients standard primary     treatment for triple negative breast cancer, and will assess the safety and activity of the     investigational medicinal product pembrolizumab.   "
10692|NCT03145948|"     This is a study to assess the pharmacokinetics, safety and tolerability of multiple ascending     oral doses of ABBV-553 in healthy volunteers and the pharmacokinetics, safety, tolerability     and efficacy of multiple ascending oral doses of ABBV-553 in participants with psoriasis     under non-fasting conditions.   "
10693|NCT03145935|"     Fluid overload increases morbidity and mortality of pediatrics patients in intensive care     unit (ICU). It could be interesting to predict the decrease in stroke volume when diuretics     are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a     diuretics induced depletion. Abdominal compression (AC) coupled with echocardiographic     measurement of the stroke volume can predict fluid responsiveness and is a good tool to     assess preload dependency. Another point is that during depletion refilling can occur. We aim     to assess the diagnostic accuracy of abdominal compression to predict a decrease of the     stroke volume of 15 % during diuretic-induced depletion of 10 ml/kg of diuresis. Secondary     outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke     volume during diuretic induced depletion   "
10694|NCT03145922|"     Sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by     gene-environment interactions. Although sarcoidosis predominantly affects the lungs in most     cases, the clinical disease course is highly variable and any organ can be affected leading     to end organ damage despite currently available therapeutics that unfortunately also have     numerous and potentially devastating side effects. The environmental triggers of sarcoidosis     are unknown but several occupational, environmental and infectious agents have been     associated with sarcoidosis in susceptible hosts. Exposure to these triggers result in     inflammation, characterized by activation of CD4+ T-cells, cytokine production, subsequent     recruitment of other immune cells, and granuloma formation. Although several genetic markers     have been associated with sarcoidosis, none fully explain individual susceptibility or     clinical course variability, strongly implicating the environment and epigenetics. We have     the ability to generate a map of the epigenetic histone modifications in immune cells via     Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and a map     of transcriptome profiles via RNA-seq. The availability of histone and transcriptional     signatures defining T cell activity in sarcoidosis will help identify the specific molecular     programs affected by disease processes and can become the basis for future discovery of novel     biomarker diagnostics in a clinical setting.   "
11981|NCT03129074|"     The purpose of the study is to assess the efficacy of varlitinib in combination with     capecitabine as measured by objective response rate (ORR) assessed by independent central     review (ICR), based on RECIST v1.1 criteria.   "
10698|NCT03145870|"     Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial     thromboembolic events. The incidence of symptomatic venous thromboembolic events is     particularly high in myeloma, linked to the usual risk factors for venous thromboembolic     disease, biological risk factors specific to myeloma, and especially to its treatments.      The prevalence of asymptomatic venous thromboembolic events and arterial events are not known     to date and remain important data for planning a possible randomized study to determine the     most suitable thromboprophylaxis in these patients.   "
10699|NCT03145857|"     A [68]Ga-HA-DOTATATE PET/CT scan is a nuclear medicine test used to create pictures of the     whole body that will show where somatostatin receptors are found, including on tumours.     Somatostatin receptors are found on most neuroendocrine tumours (NETs), and some other types     of tumours. Currently at the Cross Cancer Institute, most patients with suspected     somatostatin positive tumours (e.g. NETs) have an Octreoscan™. A scientific study has shown     that a scan with a similar product ([68]Ga-DOTATATE) is more accurate than an Octreoscan™.     This study will look at [68]Ga-HA-DOTATATE scans, a product virtually identical to     [68]Ga-DOTATATE.      The purpose of this study is to: 1) demonstrate the safety of [68]Ga-HA-DOTATATE; and 2)     confirm that [68]Ga-HA-DOTATATE is effective at diagnosing somatostatin positive tumours.   "
10700|NCT03145844|"     This study is a retrospective study conducted at 36 sites. Planned target patient number is     1000.   "
10701|NCT03145831|"     This study is a multi-center, open-label safety study assessing long-term somavaratan     administration.   "
10702|NCT03145818|"     Veteran-Directed Home and Community Based Services (VD-HCBS) is focused on preserving     Veteran's independence and the VA Office of Geriatrics and Extended Care is planning an     expansion of VD-HCBS to 90 additional VA Medical Centers over the next 3 years. This proposal     seeks to evaluate the VD-HCBS expansion to capture comprehensive information on the impact of     VD-HCBS on Veterans' and Caregivers' outcomes, as well as, to identify how the program was     implemented.   "
10703|NCT03145805|"     Bupivacaine is a local anesthetic commonly used to manage postoperative pain. Liver resection     patients typically have an epidural catheter placed preoperatively through which they receive     a continuous infusion of bupivacaine and hydromorphone for up to 5 days postoperatively. The     liver metabolizes bupivacaine, and produces proteins that bind with bupivacaine to take it     out of circulation and thereby reduce its toxicity. Because a portion of the liver is being     removed due to pre-existing liver disease, investigators hypothesize that liver resection     patients have an impaired ability to clear bupivacaine from circulation that may increase     their susceptibility to bupivacaine toxicity. To assess this, investigators will measure free     and bound bupivacaine in liver resection patients postoperatively to determine whether     bupivacaine reaches toxic levels. Investigators will also quantify binding protein levels to     determine if these levels are reduced after surgery, which could contribute to the elevated     bupivacaine levels in these patients. Finally, investigators will monitor patients for signs     and symptoms associated with bupivacaine toxicity.   "
10704|NCT03145792|"     This randomized controlled trial examines the efficacy of two behavioral therapies. Seeking     Safety, which addresses co-occurring problem gambling (PG) and posttraumatic stress disorder     (PTSD), is being compared to Cognitive-Behavioral Therapy for PG, which addresses only PG.     Both models are delivered via telehealth.   "
10705|NCT03145779|"     Cerebrovascular events, such as stroke, are a devastating complication of Fabry disease that     results in part from storage of complex lipids in both large and small vessels. Understanding     how the genotype influences the phenotype or clinical presentation can help us understand     which patients are at risk for the complications of Fabry disease. This study aims to follow     the natural history of this disease will help us understand and predict long-term outcomes     for patients.   "
10706|NCT03145766|"     This multicenter, observer-blind, controlled, randomized, Phase II study was designed to     evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.   "
10707|NCT03145753|"     Objectives: A targeted HIV testing strategy (TTS) through an HIV risk of exposure and     indicator conditions (RE&IC) questionnaire resulted in same rate of new HIV infection     diagnosis (NHID), coverage and even reduced costs compared with a universal non targeted (Non     TSS) HIV testing strategy in a prior study (DRIVE 01). To compare number of New HIV/HCV     Infection Diagnoses (NHID HIV/HCV) and costs two HIV/HCV testing programs in the Primary     Health Care: an educational and support only initiative to enhance HIV /HCV testing (EDSUP)     or EDSUP plus a resourced external program (DRIVE 03).      Methodology: Prospective, randomized 1:1, clustered, crossover study, in one Health Care Area     of Madrid, Spain, comparing the implementation of two HIV testing programs, EDSUP only vs.     EDSUP plus DRIVE 03 program in 4 Primary Care Centers (PCC´s). People randomized to EDSUP     plus DRIVE 03 program, non HIV infected, between 18-65 years, attending to any of the 4     PCC´s, not previously included in the study will be offered to participate. HIV testing     program will be evaluated by measuring absolute number of new diagnosed infections (NDI)     HIV/HCV and costs. Other outcomes considered will be people assigned and offered to     participate, number of HIV tests performed, coverage (HIV /HCV tests/assigned population     ratio), and rate of NDI HIV/HCV per ‰ tests performed. Six months prior to randomization main     outcome variables will be recorded in the 4 PPC´s. Before randomization, EDSUP will be     equally implemented in the 4 PCC´s. After randomization, first six months, DRIVE 03 program     will be implemented in 2 PCC´s and in the other 2 observation of interest variables will be     conducted. After first 6 month study period, PCC´s will be crossover to the opposite arm of     randomization. DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all     study procedures. For NDI HIV/HCV, molecular epidemiology, delayed diagnosis, retention in     care, HIV/HCV treatment and control/eradication will be also monitored.   "
11017|NCT03141684|"     This phase II trial studies how well atezolizumab works in treating patients with alveolar     soft part sarcoma that has not been treated, has spread from where it started to other places     in the body and cannot be removed by surgery. Monoclonal antibodies, such as atezolizumab,     may allow the immune system cells to find and kill the tumor cells.   "
10709|NCT03145727|"     Chemotherapy induces nausea and vomit for some large patients. But, some chemotherapy     protocol has a high indices of the incidence as observed in a combination of Anthracycline     and Cyclophosphamide (AC). To prevent this symptoms, some medication can be used as     Ondansetron. By other hands, the traditional acupuncture on Chinese Medicine have been used a     PC6 point to avoid nausea and vomit. More recently, a transcutaneous electric nerve     stimulation (TENS) also has been used for this application. Our study will test the TENS     applied on PC6 point with two different frequencies (high and low) to evaluated the nausea     and vomit inhibition effects.   "
10721|NCT03145571|"     To validate a model of Continuity of Midwifery Care implemented in the region of Nabuls and     Jericho in Palestine in 2013, register data from the Palestinian Ministry of Health will be     analyzed for the following indicators related to usage and quality.      Changes in these variables before and after the implementation will be compared between the     16 clinics where the model was implemented and all comparable clinics in the region.   "
10710|NCT03145714|"     Postoperative Cognitive Dysfunction (POCD), is a subtle decline in cognitive function     characterized by impairment of memory and reduced ability to concentrate in elderly patients     exposed to general anaesthesia. This prospective study aims to compare incidence and severity     of POCD in two groups of patients. Group P receiving Intravenous Propofol and Inhalational     anesthetic Sevoflurane. Group D receiving Intravenous Dexmedetomidine and Inhalational     anesthetic Sevoflurane, Neuropsychological Test will be performed 24 hours before surgery and     on postoperative day 3 and day 7.   "
10711|NCT03145701|"     The purpose of this study is to use a wire with a Doppler tip to measure blood flow in     vessels in the brain and determine hemodynamic factors associated with treatment success or     failure. Many neurological diseases cause abnormal blood flow in the brain in specific     vessels. The special wire used in this study is place into brain blood vessels during     standard of care procedure to treat such diseases, and blood flow parameters (such as     velocity and pressure) are measured to gain better understanding of these neurological     diseases.   "
10712|NCT03145688|"     The purpose of this study is to examine physical activity habit formation in parents and if     this can increase moderate to vigorous physical activity behavior in their children over six     months. The Primary Research Question is:      Does the habit formation condition result in increased moderate-vigorous intensity physical     activity of the child compared to the control (education) and education + planning conditions     at six months? Hypothesis: Child physical activity will be higher for the habit formation     condition in comparison to the more standard physical activity education and planning     conditions at six months.   "
10713|NCT03145675|"     The OPTIENOX-PCI is a randomized study, which is designed to assess the anticoagulation     profile of different dose regimens of enoxaparin, i.e., 0.5 mg/kg, 0.75 mg/kg, and 0.5 mg/kg     with additional 0.25 mg/kg, in about 120 patients who plan to undergo elective trans-radial     coronary angiography with or without subsequent PCI.   "
10714|NCT03145662|"     Patients suspected of having AV access stenosis will be referred to the Division of Vascular     and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who     are found to have significant stenosis (more than 50%) at the venous end of the anastomosis     will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon     (Boston scientific Balloon). Angiograms will then be performed before and after intervention.   "
10715|NCT03145649|"     Background: Breastfeeding has been associated with attenuated risk of obesity and type 2     diabetes in children born to women with diabetes. However, breast milk (BM) components     responsible for the protective effects remain to be unveiled.      Objective: To evaluate the hormone concentrations in BM of women with gestational diabetes     mellitus (GDM) and their influence on early infant growth.      Design: The investigators followed nulliparous women with and without GDM and their breastfed     term singletons. Women diagnosed with GDM received dietary therapy or insulin injection to     maintain euglycemia during pregnancy. Hormone concentrations in BM (i.e., adiponectin,     leptin, insulin, and ghrelin) were tested and infant growth was evaluated on days 3, 42 and     90. The investigators compared the hormone concentrations between the GDM and healthy groups,     and tested the associations of hormone concentrations with maternal factors (i.e., BMI,     plasma glucose concentration, gestational age, and delivery mode) and early infant growth.      Hypothesis: Hormone concentrations in BM could be determined by multiple maternal factors,     including metabolic and obstetrical factors. GDM should be a significant influencing factor     for hormone concentrations in BM.   "
10716|NCT03145636|"     This is a five-year, single arm, multi-center trial to evaluate the long-term safety and     efficacy of the Maestro Rechargeable System in treating obesity. All subjects will     participate in a weight management program, consisting of recommendations regarding diet,     exercise, and behavior modification throughout the study.   "
10717|NCT03145623|"     Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in     Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During     the French Temporary Authorization for Use (ATU) Program: Data From Real-life   "
10718|NCT03145610|"     The aim of this study was to evaluate the influence of a triclosan-containing toothpaste in     the profile of osteo-immunoinflammatory mediators in the peri-implant crevicular fluid (PICF)     and in the clinical parameters during the progression of experimental peri-implant mucositis.   "
10719|NCT03145597|"     The aims of this clinical study are:      To evaluate the clinical performance between indirect composite and ceramic laminate veneers:      Main interests are:        -  colour stability of the restoration (digital measurement in follow up)        -  failure mode of the restoration        -  wear of the restoration and antagonist      Hypothesis:        -  The colour stability of indirect composite restorations will not be different from the          ceramic restorations.        -  The indirect composite restorations will not be more prone to failure than the ceramic          restorations.        -  Antagonist wear and restorative material wear will be similar for both ceramic and          composite.      Material and Methods The laminates will be fabricated according to a specified protocol. In     order to avoid possible noticeable differences in case of distinct levels of possible     discoloration, a modified split mouth design is employed where the central incisors and the     symmetric other teeth receive the same type of restoration. Randomization is based on the     paired teeth and it is performed using the flip of a coin for the choice of material.     Evaluation will be performed at baseline and at follow-up visits annually up to 2 years.   "
10942|NCT03142685|"     To evaluate the feasibility of performing a randomized pilot control trial of two diagnostic     screening strategies for necrotizing enterocolitis in patients with congenital heart disease.     Measures to evaluate will be the ability to obtain consent from patients, percentage of     eligible patients that are able to be recruited, coordination of providers, estimation of     degree of crossover and ability to perform the screening exams per protocol.   "
10720|NCT03145584|"     Pain following total knee arthroplasty (TKA) is associated with delayed recovery, impaired     mobility, increased morbidity, longer hospital stay and greater cost. Adductor canal block     has recently been shown to improve the pain control of patients following TKA. It is not     known whether a single shot technique or a continuous catheter-based infusion technique     provides optimal analgesia. The investigators hypothesize that a continuous technique would     provide better analgesia and permit patients to achieve objective measures of recovery     following TKA than a single shot technique.   "
10722|NCT03145558|"     An open label randomized study to compare TATE versus TACE in patients with intermediate     stage Hepatocellular carcinoma who are not suitable for surgical resection or radiofrequency     ablation. The primary endpoint is Progression Free Survival. Secondary endpoints including     OS, TTP, ORR, CR rate, duration of CR, local control rate, time to local recurrence, and the     number of treatment until local recurrence. The study treatment is to administer tirapazamine     intra-arterially before injection of embolization agents Lipiodol/gelfoam, to allow     tirapazamine activation under the hypoxia environment induced by embolization. Study plans to     enroll 114 patients in 1:1 randomization for TATE or TACE. MRI will be used to assess     efficacy using a central radiological review for the final analysis.   "
10723|NCT03145545|"     The primary objective of this protocol is to expand access for patients who lack a fully HLA     (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic     hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately     life-threatening disease for which HSCT is indicated. These patients are not eligible for     other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols     that utilize CliniMACs technology for T depletion.   "
10724|NCT03145532|"     Hemiplegia occurs when the function of motor areas in the brain become impaired,     predominantly unilaterally, during perinatal development. Children with hemiplegia show     impairments in motor control of the affected side of the body. Impairments in use of the     upper extremity are common, and lead to functional disability throughout the lifespan of a     person with hemiplegia. Upper extremity impairments can severely affect a person's ability to     carry out activities of daily living.      The goal of this study at Blythedale Children's Hospital is to test the efficacy of     transcranial direct current stimulation (tDCS) and robotic upper extremity therapy in     improving upper extremity function in children with unilateral cerebral palsy. This study     will test the hypothesis that physical rehabilitation, provided by repetitive arm movements     guided by a robot, will improve upper extremity function in children with hemiplegia, and     that this improvement can be enhanced by transcranial direct current stimulation of motor     cortex immediately before robotic training.   "
10725|NCT03145519|"     A prospective, single-center, open-label, randomized controlled trial to demonstrate the     safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study     hypothesis is that OptiVein IV Catheter use will be superior to the control in successful     venous access after first attempt.   "
10726|NCT03145506|"     Freshly excised or freshly frozen tissue for Raman analysis will be obtained from a     dermatology practice affiliated with UMCB. In the course of the routine removal of benign or     malignant tumors in the office, skin cancer surgeons routinely check frozen sections to     ensure adequate margins are obtained. Consent will be obtained from patients to provide     freshly excised or freshly frozen leftover tissue obtained during Mohs surgery to be     discarded after histological diagnosis. Freshly excised tissue will be measured at the time     of excision before processing, while the freshly frozen tissue samples will be stored in a     freezer at the Mohs clinic and transferred to the UT- Austin campus for spectroscopic     analysis.   "
10727|NCT03145493|"     Problem Suction drains during TKA present certain costs to the health system and requires     additional nursing care. There is no clear evidence that supports their use, and no studies     so far have compared blood loss in patients with or without drains when TA is administered     during TKA.      Hypothesis During total knee arthroplasty, the postoperative blood loss, measured by     hemoglobin level, will be lower when no drains are used.      Method        -  Randomized controlled trial        -  Monocentric, 3 surgeons        -  Randomisation by sealed envelopes   "
10728|NCT03145480|"     This research study studies the combination of ibrutinib and obinutuzumab with or without the     standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients     with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine     Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal     needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by     targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may     be a better treatment for patients with Richter's Transformation. Depending on fitness, the     patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP     (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also     called vincristine, and P= prednisolone or prednisone (corticosteroids).   "
10729|NCT03145467|"     Migraine is a chronic and sometimes progressive disorder, characterized by headache,     recurrent episodes, and other associated symptoms. Migraine is the most common cause of     headache among patients who applied to emergency services.      The purpose of the investigators is to compare the efficacy of oral paracetamol and     zolmitriptan in the treatment of acute migraine headache in an emergency department.   "
10738|NCT03145350|"     Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world.     It is currently unclear why fat starts to accumulate in the liver, although both the amount     and type of food consumed have been implicated. The majority of studies that have     investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess     calories, which are known to increase liver fat. The effect of specific dietary components,     when consumed as part of a diet not containing excess calories, on liver fat accumulation     remains unclear.   "
10741|NCT03145311|"     This study aims to evaluate the efficacy of rTMS on DITS. Twenty patients with DITS were     recruited from the outpatient clinic of Aswan University Hospital. The patients were     classified into two equal groups, 1st group received real high frequency rTMS at 100% RMT and     the 2nd group received sham stimulation with the same pulse delivery but with the coil placed     perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5     consecutive days each week for two weeks. All patients were assessed before rTMS and     immediately after the end of the 10 sessions. This study is double blinded (the doctor and     the patients). Assessment with AIMS scale and different parameters of cortical excitability     were performed before and after the end of sessions treatment.   "
10889|NCT03143387|"     This study evaluates the patient 's discomfort when submitted to partial caries removal     through the atraumatic restorative treatment compared to chemo-mechanical caries removal     using Papacarie™ gel.   "
33998|NCT02840760|"     The purpose of this study is to explore the therapeutic effect and mechanism of transcranial     magnetic stimulation (rTMS) in the treatment of the tardive dyskinesia.   "
10730|NCT03145454|"     Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief     rests on the oral communication of the young patient, who does not always able to it     (difficult to verbalize, fear of the hospital, problem mental development ...). There is no     way in which pain can be apprehended objectively, immediately and effectively. To advance our     knowledge of this problem, several approaches have been studied as from functional magnetic     resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters.     However, all these approaches have their limitations: although fMRI presents interesting     performances, it allows only a retrospective analysis, and cannot adapt to the clinical     context of the young patient for example. EEG-based approaches and autonomic parameters show     interesting results but suffer from perfectible sensitivity to muscle activation for EEG     whereas the vegetative parameters to stress. In this context, our working hypothesis     considers that the search for markers of painful perception must be based on a     neurophysiological approach, based on the combined analysis of the EEG and autonomic     responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic     (cardiovascular, skin, pupillary) responses induced by sutures in children who can     communicate their pain according to whether they cause pain or not.   "
10731|NCT03145441|"     There are several factors initiating cytokine storm and systemic inflammatory response     syndrome (SIRS) during cardiac transplantation. This may lead to serious perioperative     complications: respiratory insufficiency, circulatory collapse, acute renal and liver     failure, multi-organ dysfunction etc.      On the other hand the high level of cytokines may play an important role in the development     of graft rejection which is still a relevant problem in this patient group.      There are some new data showing that the use of extracorporeal cytokine adsorber during long     cardiopulmonary bypass time (>120min) may be beneficial to prevent SIRS with decreasing the     level of cytokines in patients undergoing elective cardiac surgery. However there is lack of     data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac     transplantation.      The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built     in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that     removing cytokines during transplantation in this patient group prevents the development of     extreme systemic inflammatory response syndrome, early rejection and decreases the incidence     of severe perioperative complications.   "
10732|NCT03145428|"     The measurement of monocyte volume width distribution (MDW) is intended for use with adult     patients presenting to the emergency department (ED), where a CBC with Differential has been     ordered, as an aid in the early detection of patients with or developing sepsis. The study     will establish the clinical performance of MDW for detection of sepsis in the ED.   "
10733|NCT03145415|"     The purpose of this randomized blinded prospective study is to compare the analgesic efficacy     and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients,     ages 6 months to 2 years, undergoing hypospadias repair.   "
10734|NCT03145402|"     This is a prospective, randomised double blind, controlled, parallel-group phase I and II     study. Its aim is to assess that a single intracoronary infusion of autologous bone     marrow-mononuclear cells is safe and effective in hear failure patients with reduced left     ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing     best medical care.   "
10735|NCT03145389|"     Continuous thoracic epidural analgesia plays a very vital role in patients undergoing     exploratory laparotomy. It not only supports a stable perioperative hemodynamics but also     helps in early return of bowel activity.   "
10736|NCT03145376|"     Since October of 2014, the Policlinico Umberto I Hospital has an Heart Team, a group of     selected specialists with the task of assessing and identifying eligible patients for     valvular aortic transcatheter implantation (TAVI) or a placement of a MitraClip .      The specialists taking part to Heart Team are: a cardiologist, a heart surgeon, a vascular     surgeon, an anesthesiologist and a geriatrician.      The Geriatrician is called to make a careful multidimensional assessment of the elderly     patients who have been suggested for the interventions mentioned above. His role is to assess     the degree of co-morbidity and polypathology, autonomy in the common activities of daily     living, nutritional status, cognitive status and quality of life. Following this evaluation,     together with the other components of Heart Team, it is expressed a collective judgment on     the patient's eligibility to these interventions. So, the aim of the present study is to     identify changes in the degree of cognitive decline, of autonomy in carrying out activities     of daily living, quality of life, nutritional status, pre- and postoperatively (6 months     after the procedure) polypathology degree in elderly patients to be undergone or undergoing     TAVI or positioning MitraClip because suffering from aortic valvular stenosis or severe     mitral insufficiency. The patients undergo to a battery of tests, to a 5 minutes     electrocardiographic record to evaluate the Heart Rate Variability (HRV) and to a complete     echocardiographic evaluation.   "
10737|NCT03145363|"     The goal of this research project is to conduct a pilot RCT of Text4Strength, an interactive     automated text messaging extension of Sources of Strength (SoS), a universal school-based     suicide prevention program that prepares diverse 'key opinion leaders' to conduct public     health messaging and activities with peers to increase school-wide positive coping norms,     communication with trusted adults, and seeking help for suicidal peers (Wyman et al., 2010).     The investigators previously developed and field tested Text4Strength messages (RSRB#00047481     and 53924 closed) to demonstrate feasibility, safety, student engagement, and     student-perceived relevance for a universal texting extension. The investigators will now     conduct a pilot randomized controlled trial in one large school in Western New York that has     implemented Sources of Strength for the past two years. The school will continue with Sources     of Strength in the 2016-17 school, and add this school-wide texting component as part of this     research study. Consistent with Leon's guidelines on pilot studies, the primary focus will be     to identify areas of promise, success in reaching proximate targets, and the need for     additional modifications (Leon, Davis, & Kraemer, 2011). Findings from this study will inform     further refinement of the text messaging program and provide preliminary data for a larger     efficacy trial.   "
10739|NCT03145337|"     Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two     allograft dermal matrices (ADMs) currently in use for tissue assisted immediate     post-mastectomy breast reconstruction.   "
10742|NCT03145298|"     Pulmonary Arterial Hypertension or PAH is a progressive condition for which there is no cure.     Even with substantial pharmacologic advances in the modern treatment era, survival still     remains unacceptably poor, as reported in large PAH registries. Preclinical studies suggest     that the administration of allogeneic CDCs have the potential to reduce adverse arteriolar     remodeling in PAH which was the basis for the approved investigational new drug (IND). The     use of CDCs as an adjunctive therapy in patients comprising 4 sub-groups of patients with PAH     in which inflammation and immune dysfunction are key pathophysiologic drivers of PAH.   "
10743|NCT03145285|"     Adrenocortical Carcinoma (ACC) is an extremely rare disease. Approximately 50% of ACC in     adults are functioning leading to hormonal and metabolic syndromes. Cortisol hypersecretion     (Cushing's syndrome) is the most common endocrine derangement at presentation. Moreover,     hypercortisolism is one of the factors that negatively influence the outcome of patients with     metastatic ACC.      Abiraterone acetate (AA) is a prodrug of abiraterone, an irreversible inhibitor of 17α     hydroxylase/C17, 20-lyase (cytochrome P450c17 [CYP17]).The inhibition of CYP17A1 blocks     androgen and cortisol synthesis. AA has a pharmacodynamic potential to reduce cortisol excess     and it has never been tested before in Cushing's syndrome.      Thus, we decided to evaluate the activity of Abiraterone Acetate in the management of     Cushing's syndrome in patients with adrenocortical carcinoma. The study is a phase II,     non-randomized, open-label study with two different experimental sub-cohorts:      Cohort 1: Patients locally advanced/metastatic ACC patients with uncontrolled Cushing's     syndrome despite Mitotane +/- chemotherapy will be treated with single agent AA. In this     cohort, Mitotane and chemotherapy will be interrupted and AA will be continued till     progression and/or as long as the Cushing's syndrome is adequately controlled (ie until     progression of Cushing's syndrome).      Cohort 2: Mitotane-naïve patients with newly diagnosis of ACC associated with Cushing's     syndrome not amenable to surgical resection with radical intent will be treated with single     agent AA for 4 weeks followed by AA + Mitotane +/- first-line chemotherapy. In this cohort,     AA in association with Mitotane will be administered for 3 months. If the primary endpoint is     obtained before 1 month (i.e. 2 or 3 weeks from Abiraterone start), then Mitotane +/-     chemotherapy can be started upon the clinician's decision.   "
10746|NCT03145246|"     Many years ago, periodontal regenerative treatment has been done in Periodontics and Oral     Medicine Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. However, there     is still lacking of study about long-term result of periodontal regenerative treatment of     intrabony defects.   "
10747|NCT03145233|"     This pilot randomised controlled trial will directly compare the effect of isometric exercise     to isotonic exercise over a period of 12 weeks for participants with a clinical diagnosis of     Greater Trochanteric Pain Syndrome (GTPS).   "
10748|NCT03145220|"     EA-230 is a newly developed synthetic compound with anti-inflammatory properties, it is a     linear tetrapeptide derived from the human chorionic gonadotropin hormone (hCG). Recently,     its immunomodulatory effects in humans were confirmed in a phase I trial and an optimal dose     was established. To establish this anti-inflammatory effect in a selected patient population     and assess clinical outcome, a combined phase IIa/IIb trial will be conducted with patients     undergoing cardiac surgery.   "
10749|NCT03145207|"     This is a bioequivalence study to compare lidocaine release between a brand name and generic     skin patches in healthy adults.   "
10750|NCT03145194|"     This is a single-centred, double blind randomized controlled trial comparing ticagrelor with     placebo in clopidogrel and aspirin loaded patients.   "
10751|NCT03145181|"     The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule     assessed to be safe for JNJ-64007957 and to characterize the safety and tolerability of     JNJ-64007957 at the RP2Ds.   "
10775|NCT03144869|"     Physical activity (PA) can have positive health outcomes for children with type 1 diabetes     (T1DM), yet being physically active can have unwanted side effects due to fluctuations in     blood glucose (BG) level. Children and parents need support to help understand the     relationship between PA and BG level, and how to use PA as a vehicle to better manage the     condition. Using PA monitoring could help HCPs raise awareness about PA, discuss PA and     facilitate diabetes management. This research will explore the feasibility and acceptability     of PA monitoring as a clinical tool to help the management of paediatric T1DM.   "
10776|NCT03144856|"     This study is designed to see whether Apatinib is effective in treating patients with     advanced refractory biliary tract cancers.   "
10752|NCT03145168|"     Study Design:        -  A randomized controlled study.        -  The study will be conducted on patients admitted to Department of Hepatology from April          2017 to October 2017 at ILBS, New Delhi        -  Study group will comprise of patients critically ill cirrhotics with septic shock      All included patients would be randomised to low target MAP group (60-65mm Hg) or high target     group (80-85 mm of Hg). Patients older than 18 years of age will be enrolled if they have     septic shock that is refractory to fluid resuscitation and if they required vasopressors     (norepinephrine or epinephrine or terlipressin) at a minimum infusion rate of 0.1 μg per     kilogram per minute. Standard criteria will be considered to define refractoriness to fluids.     The target MAP would be maintained for a max. of 5 days or until recovery or shock and or     AKI. In the high-target group, a reduction in vasopressor doses to maintain a mean arterial     pressure of 65 to 70 mm Hg will be done in case of any of the prespecified serious adverse     events that could potentially be related to an increased rate of vasopressor infusion     occurred. These events could be: clinically relevant bleeding (i.e., transfusion requirements     of at least 2 units of packed red cells), myocardial infarction (defined as typical     electrocardiographic changes, with a concomitant increase in troponin, and segmental     echocardiographic hypokinesia or akinesia, with the infarction confirmed, when possible, by     means of coronary angiography), major ventricular arrhythmia, poorly tolerated     supraventricular arrhythmia, mesenteric ischemia, and distal-limb ischemia.      • Septic shock would be defined as clinical construct of sepsis with persisting hypotension     requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L     despite adequate volume resuscitation   "
10781|NCT03144791|"     Light influences on human movement, autonomic nervous system, and emotion. It is inconclusive     whether illuminance (Ev) and colour temperature (Tc) is appropriate to human movement,     autonomic nervous systme, and emotion. Effect of Ev and Tc on responses of movement,     autonomic nervous system, and emotion in human is investigated.   "
10782|NCT03144778|"     The goal of this clinical research study is to learn if giving durvalumab alone or in     combination with tremelimumab to patients with oropharynx carcinoma before standard-of-care     surgery can help to control the disease.      The safety of these drugs will also be studied.   "
10899|NCT03143257|"     Study to accumulate post-market clinical evidence for the safety and effectiveness of the     Sophono Alpha 2 and Alpha 2 MPO systems in subjects diagnosed with conductive hearing loss,     single-sided deafness and mixed hearing loss who currently have or have had the Sophono     implant.   "
10753|NCT03145155|"     The objectives of this cluster randomized control trial are to examine the effect of combined     intervention of the utilization of continuum of care (CoC) card and health education on the     completion of CoC services among mothers and to examine the effect of health education on     NCDs and nutrition on mothers' knowledge on NCDs and nutrition in Myanmar. Pregnant women     between 12-20 weeks of pregnancy will be recruited and assigned into intervention arm (n=600)     and control arm (n=600). The intervention package will comprise of two components, (1)     utilization of CoC card and (2) health education on CoC in maternal, newborn and child health     (MNCH), NCD and nutrition. The CoC card will include CoC services from first antenatal     care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and     four PNC and essential services. Pregnant women will get stickers if they receive above     services. Health education will be given three times during pregnancy and one time during     postpartum period. Health education will include importance of continuous uptake of MNCH     services, NCDs and nutrition. The outcomes are proportion of completion of CoC services and     knowledge on NCDs and nutrition.   "
10754|NCT03145142|"     Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to     Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who     have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San     Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24     hours of life. This data will yield the largest available sample of continuously recorded     heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and     administered FiO2 to delineate the short term responses to two methods of placental     transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with     UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in     cerebral oxygenation.   "
10755|NCT03145129|"     Some people with Primary Open-angle Glaucoma (POAG) also suffer from Obstructive Sleep Apnoea     (OSA), a common sleep disorder which is known to affect heart and blood vessels, and may     contribute to glaucoma progression. Obstructive Sleep Apnoea is treated with Continuous     Positive Airway Pressure (CPAP); however using this type of breathing support may raise     intraocular pressure (IOP). The evidence for this is limited and the potential mechanisms     involved are poorly understood.      In this study we will determine whether CPAP applied at night changes IOP and ocular     perfusion pressure (OPP). We will also assess its possible impact on ocular microvasculature.     Two groups of patients will be included: those with POAG and OSA, and those with OSA without     glaucoma. They will attend for two overnight assessments: the first before starting CPAP and     the second 4-6 weeks into the treatment. Repeated measurements of IOP at night will be     performed and participants will continue self-measuring IOP at home in the day. An Ocular     Coherence Tomography Angiography (OCT Angiography) of the optic disc and the surrounding     retina will be performed at baseline and after a few weeks of CPAP treatment.   "
10756|NCT03145116|"     Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation   "
10757|NCT03145103|"     Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation   "
10758|NCT03145090|"     Study the potential interest of bone scintigraphy for patients undergoing unicompartmental     knee arthroplasty   "
10759|NCT03145077|"     The goal of this research study is to learn if performing MRIs after radiation treatment for     head and neck cancer can predict osteoradionecrosis (a change in non-cancerous tissue).   "
10760|NCT03145064|"     Screening (up to 28 days); daily treatment until disease progression, unacceptable toxicity     or death, withdrawal of consent, lost to follow-up, or study termination from sponsor;     treatment (up to 2 years), safety follow up (28 days); survival follow-up until data cutoff     for final analysis.   "
10762|NCT03145038|"     Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially     heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat     in the treatment of heart failure in paediatric patients is planned under the paediatric     investigational plan (PIP). In order to administer vericiguat to children, a vericiguat     paediatric formulation is needed. This paediatric formulation is characterized in this study     prior to its use in paediatric patients.   "
10763|NCT03145025|"     An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes     Treated with a Fluocinolone Acetonide Intravitreal Implant   "
10764|NCT03145012|"     The immune response against tumors can be highly effective in preventing tumor development,     growth and metastasis under certain circumstances. However, tumor associated immune     suppression can profoundly limit the impact of natural tumor immunity and also reduce the     effectiveness of tumor immunotherapy strategies.      A major component of tumor associated immune suppression is mediated by myeloid cells,     especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies     that were conducted through a CCSRI Innovation grant, the investigators discovered that oral     treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or     famotidine inhibits both primary breast tumor development and metastasis, in three distinct     mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous     potential to aid in effective cancer immunotherapy and may have immediate implications for     cancer patients.      The objective of this investigation is to determine whether treatment with the H2 receptor     antagonist ranitidine alters immune suppression, through modulation of immune cell     populations.      The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers,     subsets and activation status from healthy volunteers treated for 6 weeks with daily oral     ranitidine.      Ranitidine is widely available and used over the counter in Canada. These drugs are widely     recognized as safe, well tolerated and have very few side effects. It has been suggested that     among the general population, over 10% of those over the age of 65 take such medications on a     regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical     studies in mice warrant further investigation into transferability to humans.      If the outcome of the current proposal proves to be viable, then these drugs could provide a     safe method to reduce tumor associated immunosuppression with broad implications, both for     current cancer patients and for those at high risk of developing cancer. Further to this, the     outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell     mediated immunotherapy.   "
10790|NCT03144674|"     The purpose of this study is to evaluate the safety and efficacy of two INCB050465 treatment     regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL)     who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.   "
10791|NCT03144661|"     The purpose of this study is to evaluate the safety and tolerability, and determine the     maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and     other malignancies.   "
10900|NCT03143244|"     To evaluate and compare the effect of administration of intravenous ketorolac- midazolam or     dexmedetomidine as adjuvants to general anesthesia on perioperative outcome during retinal     surgery.   "
10765|NCT03144999|"     Age related macular degeneration (AMD) is the leading cause of vision loss in individuals     over age 60. AMD is classified as wet and dry. Wet AMD constitutes 10 to 15% of all cases of     AMD and occurs when an abnormal blood vessel grows in or under the retina leading to central     vision loss. Wet AMD is successfully treated with injections in the eye on a monthly basis     that stop the blood vessel from growing and leaking. The most common form of AMD is the dry     variant or dry AMD that affects 85 to 90% of all patients with AMD. In dry AMD, there is loss     of retinal pigment, formation of deposits called drusen, and loss of the vessels in a layer     of the retina called the choriocapillaris. In the most severe forms of dry AMD there is loss     of retinal tissue called geographic atrophy. Over time retinal tissue degenerates in the area     responsible for central vision leading to vision loss leading to legal blindness. Currently     no treatment for dry AMD exists so that there is a significant unmet need in patients with     this ocular disease.      Recently, evidence has implicated an overactive inflammatory cascade called the complement     system as playing a pivotal role in the development of dry AMD. The complement cascade     consists of 3 arms that converge to form a pore-like complex on the surface of cells called     the membrane attack complex (MAC). Accumulation of MAC on cell surfaces leads to cell damage     and death causing the clinical findings seen in AMD. Normal cells within the human body     produce a protein on their cell surfaces called CD59 that blocks the MAC from forming. In     AMD, the complement cascade is upregulated and leads to more MAC formation than the body can     protect itself against leading to cell destruction.      AAVCAGsCD59, an ocular gene therapy product that is injected in to the eye in the physician's     office, causes normal retinal cells to increase the expression of a soluble form of CD59     (sCD59). This soluble recombinant version of the naturally occurring CD59 is designed and     intended to protect retinal cells that are responsible for central vision by inhibiting the     formation of the membrane attack complex (MAC), the terminal step of complement-mediated cell     lysis. In gene therapy the cells of the retina are potentially permanently altered to make     sCD59 for the life of the patient. With gene therapy only one injection is needed for the     drug to be effective for the patient's entire life. This study will evaluate the safety after     a single injection of AAVCAGsCD59 administered in an office setting for patients whose     enrolled eye has advanced dry AMD with geographic atrophy. The initial study is 26 weeks     followed by an additional 18-month safety evaluation.   "
10766|NCT03144986|"     OBJECTIVE: Anorexia Nervosa (AN) is a complex disorder of unknown etiology that is     characterized by disordered eating behaviors and specific psychopathology. In the course of     anorexia around 50% will recover in the first 10 years, 25% will continue to experience     symptoms but will be able to function, and 25% will go to develop chronic course, and by     definition become severe treatment resistant(Tr). There is little if anything to offer to     this population where the range of treatment options is limited to weight restoration     interventions. Transcranial magnetic stimulation (rTMS) is a non-invasive intervention, which     presents a particular interest in people with severe TrAN, specifically because of its     ability to target deeper areas of the brain, such as insula, which has been argued to be a     possible trait marker for AN. METHODS: This pilot study will test the efficacy and safety of     deep-rTMS delivered with the H-coil in subjects with long standing treatment resistant severe     anorexia nervosa (TrAN).   "
10767|NCT03144973|"     Periodontitis is a infection of mouth gingival mucosa and connecting tissue. It has been     shown in previous studies to have a effect on the risk of heart diseases getting worse and     elevate risk in heart surgery. The investigators are studying periodontitis and how it     affects upper gastrointestinal tract patients complication rates and the quality of     complications.   "
10768|NCT03144960|"     Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke     patients with proximal occlusion within 4.5 hours from stroke onset.   "
10769|NCT03144947|"     Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of     Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced     /Inflammatory HER2-positive Breast Cancer (ImmunHER)   "
10770|NCT03144934|"     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose     study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers   "
10771|NCT03144921|"     EPIC II (Early-Stage Partners in Care) is a research project designed to assist people with     early-stage memory loss and their care partners by providing early-stage related education     and skill-training sessions designed to reduce stress, enhance well-being, manage challenges,     and plan for the future. Researchers will gather feedback from individuals about their     experience to continue to improve programs for early-stage memory loss.   "
10772|NCT03144908|"     Design of this study is to collect data and review Principal Investigators standard operating     procedures on allergy testing and changes made to their specific SOP.   "
10773|NCT03144895|"     Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is     required and recommended. The installation of an arterial catheter in intensive care is very     frequent and subject to many complications. These complications are now well recognized in     the literature, they are mainly vascular, infectious and thrombotic. They are directly     influenced by the number of attempts to puncture and the time taken to perform the gesture.     Many measures are taken to reduce the impact such as the choice of the site of installation,     the strict aseptic techniques during the installation and the type of catheter used. However,     despite these measures, it appears that the incidence of these complications remains high.     Compared to anatomical marking, only the technique of laying the ultrasound-guided catheter     has shown its effectiveness in reducing these complications. The management in intensive care     of increasingly complicated, severe, elderly patients with significant comorbidities     increases from year to year. To the knowledge of the investigator, there is no study on the     impact of ultrasound arterial catheterization in patients in resuscitation.   "
11018|NCT03141671|"     This research study is comparing two different combinations of androgen deprivation therapy     (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy     (prostate cancer).   "
10777|NCT03144843|"     This multicenter, randomized, double-blind study will evaluate the efficacy and safety of     apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric     cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.      Patients will be randomized to one treatment arm: Arm A: apatinib 500mg qd, Paclitaxol     80mg/m2, d1, d8, d15,every 4 weeks ; Arm B: placebo 500mg qd, Paclitaxol 80mg/m2, d1, d8,     d15,every 4 weeks ; Tumor assessment will be done every 8 weeks according to RECIST 1.1. The     primary endpoint is progression free survival (PFS).   "
10778|NCT03144830|"     This study will examine the safety and feasibility of using an exoskeleton in subjects who     are less than 6 months post spinal cord injury (SCI).   "
10779|NCT03144817|"     This is a pilot randomized clinical trial in which patients treated with 3X per weekly     conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and     followed for safety and tolerability, effects on BP and volume.   "
10780|NCT03144804|"     This research study is studying a drug as a possible treatment for p53 mutant metastatic     colorectal cancer.      The drug involved in this study is:      -Lamivudine   "
10783|NCT03144765|"     Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone     of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation     treatment (CRT), complete TME with negative resection margins is associated with sustained     local and systemic control even in locally advanced disease. Over the last 2 decades,     laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical     trauma and faster patient recovery. Yet, both approaches are associated with equivalent     postoperative morbidity and disturbances in sexual, urinary and defecatory function relative     to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial     conversion rates and variable rates of TME completeness as a result of the procedural     difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with     laparoscopic assistance was developed to facilitate completion of TME using a primary     transanal endoscopic approach. Transanal TME uses a bottom-up approach to overcome the     technical difficulties of low pelvic dissection using an abdominal approach. Published     results from single-center taTME series and an international registry suggest the short-term     procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter     phase II study has yet been conducted to validate the procedural safety, functional outcomes     or long-term oncologic outcomes of this approach.      Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety     and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic     assistance in 100 eligible subjects with resectable rectal cancer.      Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME     achieved.   "
10784|NCT03144752|"     The purpose of this study is to determine if medical, biological, psychological, and social     risk factors can be used to develop algorithms that will predict perinatal depression (PND).     Data capture will include baseline participant medical, psychological and family history,     blood biomarkers, and psychosocial assessments.   "
10785|NCT03144739|"     Background: Mental health problems cause a disproportionate burden of disability among     children and youth compared to adults. Primary care plays an important role in efforts to     prevent and intervene early in the course of child and adolescent mental health problems.     While research with adults has shown the feasibility of integrating mental health care into     primary care settings, there have been few studies among children and youth. Evidence remains     lacking that integration is feasible in diverse settings, that it improves outcomes, and that     methods can be developed to address the mixed symptoms of emerging child/youth problems and     their overlap with developmental and parental disorders.      Goals: The purpose of this project is to test the effectiveness of adding a child/youth     mental health component into an existing collaborative care program for adult mental health     problems. The work will refine a framework for efficient cultural adaption and tailoring of     an existing child/youth primary care mental health intervention and then test whether the     tailored intervention results in improved child and parent outcomes. The work will also     provide evidence about the mechanisms by which those outcomes are achieved and what factors     influence uptake of the child/youth component by general practitioners (GPs). These results     should be generalizable to low and middle income countries and to underserved areas of the US     where there are minimal child mental health resources and family physicians provide the bulk     of medical care for children and youth.      Methods: The planned work involves the adaptation/tailoring process followed by a trial with     45 GPs already engaged in collaborative care for adults; the trial will study adding     collaborative care for children ages 5-15. GPs will be randomly assigned in groups to begin     6-month control periods involving child mental health screening and referral. They will then     receive child/youth training and begin second 6-month periods of screening plus ongoing     coaching and booster sessions and collaborative management. Primary outcomes will be measured     by recruiting and following for 6 months two cohorts of children/youth and their parents (one     control, one collaborative care). Data collected from GPs, parents, youth, and the     collaborative care data system will allow measurement of key factors that determine the     program's success in helping children and families.   "
10786|NCT03144726|"     Surgical site infections following lower extremity amputations have been reported in up to     40% of patients. Surgical site infections have significant morbidity and even mortality in     terms of emergency room visits, length of hospital stay, reamputation rates and death. Since     its introduction, negative pressure wound therapy has been demonstrated to promote wound     healing and possibly decreasing the need for future amputations. The aim of the study is to     provide level I evidence for the use of negative pressure wound therapy devices in patients     undergoing lower extremity amputation.   "
10797|NCT03144583|"     To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from     peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen     receptor with anti-CD19 specificity [A3B1] conjugated with the co-stimulatory regions 4-1BB     and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to     treatment and with a prognosis of less than 2 years.   "
10798|NCT03144570|"     Prospective observational multicenter study in European ICUs. All patients admitted to the     ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of     America criteria) will be included. Factors associated with a poor prognosis will be     identified by multivariate analysis using a logistic regression.   "
11019|NCT03141658|"     The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD     signals in ROIs in resting fMRI in healthy adult subjects.   "
10787|NCT03144713|"     -  Study Population: Patients admitted or seen in Out Patient Department, Department of          Hepatology, Institute of Liver and Biliary Sciences.        -  Study Design: Prospective Open Labeled Randomized Controlled Trial.        -  Study Period: January 2017 to December 2017        -  Intervention- Subjects will be randomized to 3 groups        -  All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of          dose at beginning of tap and rest half after 6 hours of tapping.      Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of     paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose.     ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only        -  Monitoring and Assessment: Clinical evaluation will be done at regular intervals.        -  Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely          cardiovascular side effects have been noted.        -  Stopping Rule: Development of PICD, hypertension ( BP>160/90mmhg-JNC class II)   "
10788|NCT03144700|"     Study Design and Methodology        -  Study Population:Compensated Cirrhosis        -  Study Design: An Ambi Prospective Cohort study        -  Study Period: 2 Years        -  Sample size: Retrospective- All patients from Jan 2010 to Mar 2017 Prospective- Assuming          the incidence of clinical decompensation is 5%/year.With alpha of 5%, power 80% we need          to enroll 138 cases. Further assuming 20% drop out 166 cases will be enrolled.        -  Intervention: This is an observational study. No intervention will be given.      Monitoring and assessment: All the routine investigation and clinical information will be     collected at 6, 12,18 and 24 months.   "
10789|NCT03144687|"     The purpose of this study is to evaluate the efficacy and safety of itacitinib combined with     low-dose ruxolitinib or itacitinib alone in subjects with myelofibrosis.   "
10792|NCT03144648|"     Breast cancer has become a major public health problem in Latin America, as it is the most     common form of cancer among women. Women are more likely to develop breast cancer at younger     age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty     years, the mortality from breast cancer in Latin America has also been increasing very     rapidly, and is currently the leading cause of cancer mortality. Little is known on specific     risk factors for premenopausal breast cancer in general, and in Latin America in particular.     There is a lack of specific knowledge on tumor molecular and pathological characteristics of     breast cancer in Latin America premenopausal women, and this has major consequences on cancer     treatment and survival.      To improve our understanding on determinants of breast cancer incidence and mortality in     young Latin America women and support preventive actions, we implemented an international,     population-based multi-center study in Latin America: the PRECAMA study (Molecular Subtypes     of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter     population-based case-control study).      PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is     conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major     aims of the project are the following:        1. To develop a multi-centric population-based case-control study on breast cancer in          premenopausal women in several countries in Latin America with structured collection of          individual, clinical, pathological information and biological specimens, according to          strictly controlled protocols        2. To characterize, in these populations, the subtypes of premenopausal breast cancer on          the basis of their molecular and pathological phenotypes        3. To improve the identification of specific endogenous/exogenous factors, and disentangle          the interplay of these different factors with regard to breast tumor subtypes.        4. Provide advanced training, induce a structuring effect on the breast cancer research          community in Latin America and influence the public health agenda regarding the          management of breast cancer.      The results of our study will be of utmost importance to understand the etiology of breast     cancer in Latin America countries, and would provide important information on the role of     modifiable exposures for breast cancer prevention.   "
10793|NCT03144635|"     The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may     safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are     metabolized in the liver and do not require dose-adjustment for patients with renal     dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir     treatment for Japanese elderly patients with renal dysfunction (eGFR<60 mL/min/1.73m2) have     been reported. Therefore, physicians are at a loss whether or not to treat the patients with     renal dysfunction due to no evidence.      The aim of this study is to investigate the improvement of serum endostatin level of Japanese     patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A     replication complex inhibitor) treatment by a prospective, multicenter cohort study.   "
10794|NCT03144622|"     This study aims to compare the diagnostic performance of 18F-FDG and 18F-FSPG PET/CT in lung,     breast, and abdominal cancers before undergoing therapy. In addition, the role of 18F-FSPG     PET/CT in evaluating therapy response and prognosis will also be evaluated.   "
10795|NCT03144609|"     The prevalence of obese patients in a great number of patients scheduled for elective surgery     under general anesthesia has been on the increase. Recent studies suggest an intraoperative     protective mechanical ventilation for the obese. Surgical procedures in the oral cavity     increase the risk of perioperative complications of obese patients. By making this randomized     clinical study, investigators want to determine whether the protective intraoperative     ventilation with the use of higher positive end-expiratory pressure and recruitment maneuvers     compared to ventilation with low positive end-expiratory pressure and without recruitments     cause better postoperative respiratory function parameters of obese patients during oral     surgical procedures. Investigators also aim to establish the fact which value of a positive     end-expiratory pressure has a favorable impact on the respiratory function without negative     hemodynamic effect.   "
10796|NCT03144596|"     It was aimed to evaluate and investigate the effects of tamsulosin hydrochloride, has     preferential selectivity for the α1A receptor in the prostat versus the α1B receptor in the     blood vessels, and alfuzosin hydrochloride on choroidal thickness (CT), pupil diameter sizes     evaluated by using enhanced depth imaging spectral-domain optical coherence tomography     (EDI-OCT) and scheimpflug/placido photography-based topoghraphy system in this study.      63 men patients with newly diagnosis of benign prostatic hyperplasia were randomly assigned     to either alfuzosin hydrochloride or to tamsulosin hydrochloride groups in this prospective,     randomized, parallel-group clinical trial. Enhanced depth imaging spectral-domain optical     coherence tomography, pupillography were obtained at baseline, 1st and 3rd month, and     choroidal thicknesses and pupil diameter sizes were compared between the 2 groups.   "
10943|NCT03142672|"     The aim of this retrospective study was to compare immediate postoperative pain scores and     the need for rescue analgesia in children who underwent pulpotomies and general restorative     treatment and those who underwent general restorative treatment only, all under general     anaesthesia.   "
10800|NCT03144544|"     When considered from a provincial perspective, quantification of surgical procedures     undertaken by different hospitals and healthcare networks is necessary for informing resource     allocation and modelling of healthcare services. The investigators hypothesized that i)     non-physiologically complex surgical procedures would account for most (>1/2) of pediatric     surgical procedures performed at both pediatric specialist hospitals and the other hospitals     performing pediatric surgery, ii) surgical discharges for non-physiologically complex     surgical procedures would account for most (>1/2) in-hospital bed nights among pediatric     surgical admissions at both pediatric specialist hospitals and the other hospitals performing     pediatric surgery, and iii) the relative distributions of non-physiologically complex     surgical procedures, but not physiologically complex procedures, would be at least moderately     similar between pediatric specialist hospitals and the other hospitals performing pediatric     surgery. To test these 3 hypotheses, the specific objectives of this study were to estimate     i) the proportion (primary outcome) of non-physiologically complex pediatric surgical     procedures, and ii) the similarity and diversity (secondary outcomes) of non-physiologically     and physiologically complex surgical procedures between the pediatric specialist hospitals     and the other hospitals performing pediatric surgery in Ontario, Canada.   "
10801|NCT03144531|"     Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance     and a parent with sleep disturbance.   "
10822|NCT03144258|"     General objective of the research project: To evaluate the alterations of systemic     microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to     cardiac surgery for repair of congenital heart defects.   "
10823|NCT03144245|"     This is a first in human, non randomized, open-label, dose escalation study to investigate     the safety, tolerability and preliminary efficacy of AMV564.   "
10824|NCT03144232|"     This investigation will preliminarily determine if a course of high frequency rTMS applied to     the left dorsolateral prefrontal cortex, will reduce cue elicited craving, and cue reactivity     in treatment seeking cannabis use disordered participants.   "
37472|NCT02795143|"     The purpose of this study is to determine whether isotretinoin is helpful in treating     patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN).   "
10803|NCT03144505|"     To overcome the lack of knowledge regarding the relative role of different intensities of     aerobic training in adults with type 2 (T2D) diabetes, a 12 month randomized controlled trial     will be performed to assess and compare the impact of two exercise groups: 1- high intensity     interval training (HIIT) with resistance training; 2- moderate continuous training (MCT) with     resistance training; and 3- a standard counseling home based control group; on hemoglobin A1c     (HbA1c) as the main outcome, and other selected cardiometabolic, body composition and quality     of life markers, as secondary outcomes. This investigation aims to increase the current     knowledge on HIIT and the related benefits on diabetes control and treatment in a time saving     and physiological efficient framework, which will improve the general health and well-being     of the diabetes population. A total of 105 participants with T2D will be recruited from the     Lisbon area (35 control, 35 HIIT, and 35 MCT). The investigators hypothesize that     high-intensity interval training, compared to moderate continuous training, will optimize the     physiological adaptations and quality of life in people with type 2 diabetes.   "
10804|NCT03144492|"     The goal of this study is to assess the affect of ground based microgravity on co-cultured     vascular cell types. Our goal is to better understand the cross-talk between vascular cell     types grown under conditions such as microgravity as is seen in space. In this pilot study,     the investigator proposes to assess changes in cell phenotype and function in microgravity as     compared to normal gravity.   "
10805|NCT03144479|"     A technique not yet described in the literature and allowing anesthesiologists who do not     regularly practice fibroscopy or who do not routinely have this type of apparatus for their     procedures, to install straight double-lumen tubes without compromising the ventilation of     the patient. The aim is to introduce a central venous catheter wire guide into the bronchial     arm of the right double-lumen tube and insert it into the right upper lobe bronchus orifice     under fluoroscopic control. Then, to validate the new technique, we will carry out a     fibroscopic control.   "
10806|NCT03144466|"     Locally advanced cervix cancers (stage 1B-IV) are usually treated with radiotherapy,     concomitant cisplatin chemotherapy and brachytherapy. Failure to achieve locoregional control     (LRC) remains a problem, especially in the setting of stage III/IV disease. More importantly,     however, the dominant unresolved problem remains the occurrence of distant metastatic     relapse. With the knowledge that 99% of all cervix cancer is associated with human     papillomavirus (HPV) infection, there is a strong rationale to consider immunomodulatory     strategies in the radical management of this disease. Therefore, in this research protocol     the investigator will treat patients with stage 1B-IVA carcinoma of the cervix planned to     receive radical radiotherapy with concomitant cisplatin and brachytherapy. The research     involves adding a new therapy in the form of an antiPD1 monoclonal antibody (pembrolizumab)     to the standard treatment of radiotherapy combined with cisplatin chemotherapy and     brachytherapy. This treatment seeks to activate the patient's own immune system to attack the     cancer cells - and the investigator believes that adding this treatment during standard     treatment may be particularly effective. Patients will receive an initial dose of     pembrolizumab 2 weeks before starting a course of chemoradiotherapy and brachytherapy. In the     first instance, patients will receive 100 mg of pembrolizumab and, if this is safe and     tolerable in the first 3 patients, the dose will be increased to 200 mg for all other     patients. Radiation will be delivered on 28 occasions with chemotherapy given intravenously     in weeks 0, 1, 2 and 3. Brachytherapy will be given on 3 occasions after completion of the     radiation. Additional doses of pembrolizumab will be given every 3 weeks for a further 7     doses. The investigator will assess the feasibility and safety of the combination of     pembrolizumab with radiotherapy and cisplatin.   "
10807|NCT03144453|"     Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep     Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the     final stages of surgery. The aim of this study was to evaluate the quality of awakening in     two groups of patients undergoing different combinations of curarization/reversal.   "
10808|NCT03144440|"     Primary objective:      1. To estimate the effectiveness of treatment with FDC of Zepatier with or without ribavirin     in Israeli patients with CHC and advanced fibrosis in real life setting.      Secondary objective:      1. To estimate the safety and tolerability of treatment with FDC of Zepatier with or without     ribavirin in real life setting in Israeli patients with CHC and advanced disease.      Hypotheses:      Effectiveness and tolerability of treatment with FDC of Zepatier with or without ribavirin in     Israeli patients with CHC and advanced fibrosis will be similar to that demonstrated in phase     3 clinical trials.   "
10809|NCT03144427|"     This is a prospective, non-interventional, observational study of consecutive burn patients     admitted to 20 selected burn centers in North America. Primarily, data collection will be     continuous real-time documentation of fluid infusion rates, vital signs and laboratory     values of patients receiving fluid resuscitation during the first 48 hours following burn     injury. All aspects of the resuscitation and all investigations performed will be according     to the participating center's regular protocol, as this is purely an observational and     non-interventional study. Further data collection on outcomes (organ function, ventilation     duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital     discharge.   "
10810|NCT03144414|"     This prospective randomized clinical trial will be conducted in Ain Shams University     Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients     will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30     patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)   "
10811|NCT03144401|"     This prospective double-blind placebo-controlled randomized clinical trial will be conducted     at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women     candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of     misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of     misoprostol.   "
10812|NCT03144388|"     The primary goal of the proposed study is to identify the contributions of the amount of     task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1     yr) motor incomplete spinal cord injury (iSCI). Consistent with principles of motor learning     and exercise physiology, the investigators contend that certain training (i.e., dosage)     parameters of physical rehabilitation are critical to mobility outcomes following     neurological injury. Specifically, the specificity, amount and intensity of physical     interventions (i.e., practice) may influence specific outcomes in the patient population     treated. In ambulatory patients with iSCI, there are very few studies that have controlled     for or targeted these training variables or their influence on locomotor recovery. Previous     work suggests these training parameters may influence locomotor recovery in patients with     other neurological disorders (i.e., stroke), although few studies have attempted to delineate     similar contributions of in iSCI. Indeed, no studies have carefully controlled the amount of     task-specific practice during physical rehabilitation of patients with iSCI, and such     interventions are rarely utilized in the clinical setting. The goal of the present study is     to delineate the relative contributions of amount of task-specific training on locomotor     outcomes in individuals with iSCI. Using a cross-over, randomized clinical trial design, the     investigators anticipated non-specific (i.e., non-stepping) training activities would result     in smaller improvements as compared to task-specific (stepping) training. The investigators     will investigate the effects of such training on walking performance and kinematics, as well     as the impairments thought to contribute to walking performance. Successful completion of     this project could have an immediate impact on rehabilitation research and treatment of     people following iSCI, and may be utilized to treat more subacute patients with iSCI or other     acute-onset neurological disorders.   "
10813|NCT03144375|"     Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16%     in the western population. The main outcome measure for chronic disease treatment, such as     CRS, is quality of life. Several large multi-institutional studies have shown that     improvement in disease specific Quality of life was greater in patients who had surgery for     their CRS with polyps. The timing of surgery in these patients has not been well studied but     it is generally agreed upon that surgical candidates much had failed medical management. The     definition of medical management varies greatly but usually includes some form of nasal or     oral steroids and a prolonged ( >10 days) course of antibiotics.      Another known way to improve QOL is through education and individualized optimization. This     has been utilized successfully in other fields with good success and improved QOL. Similar     studies looking at combining non-surgical optimization and education have not been performed     in CRS. This study aims to address this potential area for improvement in patient quality of     life outcomes. Investigators plan to assess the potential role for pre-operative non-surgical     medical and educational optimization in CRS standard of care treatment.   "
10814|NCT03144362|"     Sciatica is a debilitating and costly condition. Prognostically, patients presenting with leg     pain often have a poor recovery and some go onto have spinal surgery. However, in the absence     of nerve root compression on MRI, no surgical option is viable and patients are often     discharged and encouraged to self manage. Neurodynamics offers a means to treat patients with     non-compressive leg pain. To date, there is no research exploring which form of neurodynamic     sliding technique offers the greatest therapeutic benefit in patients presenting with     sciatica. The aim of this pilot study is to calculate how many patients would be needed to     run a full scale trial evaluating therapeutic efficacy. Moreover, the pilot will assess the     overall workability of the study and the feasibility of patient recruitment.   "
10815|NCT03144349|"     The aim of the study is to analyze if blood protein concentration variation during continuous     renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac     index in intensive care unit (ICU) patients. Blood protein concentration, clinical data     describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ®     monitoring), including preload dependency evaluation with passive leg raising, are collected     at different times: before initiation of fluid removal, and after the first episode of     hypotension or one hour after initiation of fluid removal.   "
10816|NCT03144336|"     This project called Mobile Technology and Incentives (MOTIVES) aims to increase engagement     with HIV prevention information and improve testing frequency among Latino/a men who have sex     with men (MSM) and transgender women (TGW). Its primary goal is to develop and test the     feasibility and acceptability of an HIV prevention intervention that uses text messages in     combination with prizes to improve HIV prevention information retention and HIV testing     frequency. The project will be conducted in collaboration with Bienestar Human Services, Inc.     (Bienestar) in Los Angeles County. Phase 1 consists of formative research (focus groups n=9)     with MSM (n=52) and TGW (n=39) to complement the previously collected pilot data (2014-2015)     to finalize the planned intervention. In Phase 2, the intervention will be piloted among 5     individuals, implemented, and tested in a small, randomized controlled trial (RCT) among 200     Latino MSM and TGW from Bienestar's HIV testing sites. Interested individuals will be     screened for eligibility upon testing HIV-negative (those testing positive will be linked to     HIV services as required by Bienestar's standard of care). Eligible participants will be     randomized into either the intervention or control group that will both receive study     information weekly and will be invited to get tested for HIV every three months. Participants     in the intervention group will be able to accumulate rewards points for correctly answering     weekly quizzes regarding the HIV prevention information; these reward incentives aim to     encourage retention in the study and improve HIV prevention knowledge engagement and     recollection. Every three months those in the intervention group can win a prize based on     testing HIV-negative at least once during that time period. The chance of winning will     increase based on the number of reward points a participant accumulates by correctly     answering questions on the weekly quizzes. The primary outcome measures will include     HIV-preventive knowledge and frequency of HIV testing (at least once every 3 months). In     Phase 3 of the study, the investigators will conduct 6 focus groups with approximately 5-8     participants each among MSM (n=3) and TGW (n=1) study participants, testing site staff (n=1),     and administrative staff (n=1) to identify implementation challenges and areas for     improvement; and estimate mission-critical design parameters with point and confidence     interval estimates to inform a subsequent, fully-powered R01 application.   "
10944|NCT03142659|"     The investigator is trying to improving our knowledge in the treatment of HF patients, for     the purpose of improving their quality of life and reducing hospitalizations. For achieving     this the investigator would like to build a registry which will include all the HF patients     going an evaluation in the Heart Failure unit or clinic in our facility,   "
10817|NCT03144323|"     Fixed orthodontic appliances in combination with intraoral elastics are a common and     effective method use in the orthodontic correction of malocclusions. However, their success     is largely dependent on the patient's compliance. Failure to wear the elastics as instructed     will reduce efficacy of treatment, ultimately increasing treatment time and potentially     producing imperfect alignment of teeth.      The hypothesis tested is that daily electronic reminders via a mobile application can     significantly increase patient compliance, thus effectively improving treatment outcomes.   "
10818|NCT03144310|"     Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound     with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest     auscultation and ultrasound to see atelectasis   "
10819|NCT03144297|"     Background: It has already been established that there is a weak positive relationship     between increased intracranial pressure (ICP), as measured by lumbar puncture manometry, and     increased Body Mass Index (BMI). This is also observed clinically in some patients with     idiopathic intracranial hypertension, who typically have raised BMI. The relationship between     BMI and percentage body fat is non-linear, especially at BMI > 40. The Bod Pod device enables     non-invasive body composition profiling, including accurate calculation of percentage body     fat, without the use of radiation.      Aim: To examine the relationship between intracranial pressure as measured by lumbar puncture     manometry and percentage body fat as measured by air-displacement plethysmography (Bod Pod)      Methods: 100 patients undergoing routine diagnostic and therapeutic lumbar punctures for a     variety of non-emergency neurological conditions will be recruited. Cerebrospinal fluid     opening pressure will be measured using standard manometry techniques. Blood pressure,     height, weight, collar size, waist size and hip size will be measured. Body composition     profiling will be carried out using the Bod Pod.   "
10820|NCT03144284|"     Minimal intervention dentistry (MID) is a modern medical approach that aims to maximize     preservation of healthy dental tissues. When operative intervention is required it is as     minimally invasive as possible. This study will assess the knowledge of a group of dental     interns regarding minimal intervention dentistry in Egypt and whether this knowledge is     translated into positive attitude and practice among them.   "
10821|NCT03144271|"     This trial is conducted in Europe. The aim of this trial is to assess the safety and     tolerability of ascending single s.c. doses of NNC 0113-0217 in healthy male subjects, aiming     at establishing the Maximum Tolerated Dose (MTD)   "
10825|NCT03144219|"     Introduction: Intracranial pressure (ICP) monitoring is essential in several neurological     situations, however, this is an invasive technique, costly and could be contraindicated or     unavailable. Transcranial Doppler (TCD) pulsatility index (PI) measure can provide indirect     information on the cerebrovascular resistance (CVR) augmentation, which is present     concomitantly with intracranial hypertension (ICH). The hypothesis that PI measure accurately     indicates cerebral compliance impairment (CCI) has been not assessed by large studies     currently, and would be of value as a non invasive technique to denote earlier installing of     therapeutics to prevent the effects of ICH.      Objective: The present study aims to assess PI accuracy indicating CCI, and dynamic cerebral     auto regulation (dCAR) during internal jugular veins (IJVs) compression.      Methods: A prospective, observational controlled study, including critical neurological     patients with ICP monitoring in normal range (under 20 mmHg). Initially, dCAR is monitored,     then, the IJVs are compressed for 60 seconds with ultrasound guidance. We evaluate optic     nerve sheath prior to intervention, and dCAR, ICP values, ICP waveforms and PI variation at     different times, correlating results.   "
10826|NCT03144206|"     A prospective, randomized investigation with appropriate power would determine whether or not     postoperative hyperbaric oxygen therapy improves wound healing in patients with soft tissue     sarcoma undergoing surgical resection with neo-adjuvant radiation therapy.   "
10827|NCT03144193|"     Photoaged or chronically sun-exposed skin is characterised by a number of clinical features     including fine and coarse wrinkles. The pathogenesis of wrinkle formation has yet to be     determined fully but recent work suggests that ultraviolet radiation-induced reduction in     dermal fibrillin (in the form of fibrillin-rich microfibrils) is important. Using an extended     in vivo patch test assay, it has been identified that skin care products - currently marketed     by CG Skin Ltd - increase the deposition of these microfibrils in photoaged dermis and hence     have the potential to repair photoaged skin. The Investigators now propose to examine the     efficacy of the product in randomized, placebo-controlled clinical trial.   "
10828|NCT03144180|"     Currently there is no standardized method of collecting and transferring umbilical cord blood     to laboratory vacuum tubes. Current methods are messy and may require needles to draw the     blood presenting risk of blood exposure and percutaneous injury to obstetrical personnel. A     safer, more efficient method of collecting cord blood is needed. We propose to use our Q-Cup     technology for collecting cord blood. Our Q-Cup device is a two-piece injection molded blood     collection and transfer device that enables safe and easy collection of blood from the     newborn's umbilical cord and readily transfers the blood into a laboratory vacuum tube. The     device consists of a collection cup with a wide opening to easily collect blood from the     umbilical cord and a guide tube with a recessed needle which is attached to the collection     cup. The operator is enabled to fill the required vacuum containing tubes in a clean, quick,     efficient and safe manner by simply inserting the vacuum tube into the guide tube of the     Q-Cup. As a result, there is less risk of blood exposure and percutaneous injury and blood is     collected more efficiently. This device allows the practitioner to collect and transfer     umbilical cord blood: without the need for removing the stopper from the vacuum tube     (reducing mess and contamination) and without the need for a syringe and exposed needle     (reducing injury and infection).   "
10829|NCT03144167|"     No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule     (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy.     Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival     and response or duration. We propose to evaluate the prognostic interest for 6-month survival     of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic     metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the     treatment.      These biomarkers are based on the increase of an index combining choline / Creatine (Cho /     Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine)     and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed     GBM patients at an early stage and to identify responder patients who would benefit from this     expensive molecule and avoid using it in non-responding patients   "
10830|NCT03144154|"     Hypnosis-based interventions are starting to be tested in order to improve emotional distress     and fatigue of cancer patients. However, most of these studies only include breast cancer     patients and do no measure long-term effects of such interventions.      Our randomized controlled trial aims to propose to 116 post-treatment cancer patients (all     tumour localisations accepted) an 8-week groupal intervention combining hypnosis and     self-care techniques.      Primary outcomes (emotion regulation, emotional distress, fatigue) and secondary outcomes     (sleep difficulties, fear of recurrence, attentional bias, conjugal communication) will be     investigated at 3 measurement times: before the intervention (T1), 3 months later (T2 - right     after the intervention of the experimental group, and right before the intervention of the     control group) and again 3 months later (T3 - after the intervention of the control group).     Some questionnaires, two relaxation tasks, an attentional task, an actigraph and a smartphone     application will be used to collect data. The indirect impact of the intervention on     participants' partners will also be measured by questionnaires (emotional distress, conjugal     communication).      Data collection has started on March 2017. Our results should bring new knowledge about the     efficacy of an hypnosis-based intervention to improve fatigue and well-being in cancer     patients, which are often under-diagnosed and under-treated, but also about the indirect     efficacy to improve partners' well-being. Those results might contribute to spread this kind     of inexpensive intervention in oncology settings.   "
10831|NCT03144141|"     Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading     cause of perinatal morbidity and mortality in economically developed countries. Despite the     development of therapeutics and paraclinic examinations, this rate of preterm delivery     remains stable or even increases. The use of medically assisted procreation techniques alone     can not explain this rate.      The analysis of the electrical activity of the uterus (electrohysterograms) is a promising     technique for early diagnosis of the risk of premature delivery, allowing better management     of the patients. This study is part of a European theme to study risk factors for the     prevention of prematurity.   "
11799|NCT03131453|"     The purpose of this study is to determine the effects of CNP520 on cognition, global clinical     status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for     the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.   "
10832|NCT03144128|"     The proposed study is aimed at examining mitochondrial function as a potential target of     action of vitamin D on muscle metabolism, size, and strength in preventing the progression of     cachexia. This is the first clinical trial designed to understand the effects of vitamin D on     muscle metabolic dynamics driving dysfunction in cachectic muscle. Our preliminary data     suggest that vitamin D promotes lipid partitioning and muscle metabolic function, which the     investigators hypothesize, will mitigate cachexia via improved muscle health and quality that     translates into reduced fatigue, and improved patient resilience to multimodal cancer     therapy.   "
10833|NCT03144115|"     The aim of the study is to explore how the rewarding effect of men's verbal compliment is     modulated by oxytocin and gonadal hormone in a romantic context.   "
10834|NCT03144102|"     Stroke represents one of the main causes of adult disability and will be one of the main     contributors to the burden of disease in 2030. However, our healthcare systems do not have     enough resources to cover the current demand let alone its future increase. There is a need     to deploy new approaches that advance the current rehabilitation methods and enhance their     efficiency.      One of the latest approaches used for the rehabilitation of a wide range of deficits of the     nervous system is based on virtual reality (VR) applications, which combine training     scenarios with dedicated interface devices. On the other hand, recent studies have shown the     potential of transcranial direct current stimulation (tDCS) to restore motor function in     hemiparetic stroke patients. It must be emphasized, however, that so far little work exists     on the quantitative assessment of the clinical impact of VR based approaches in combination     with tDCS protocols. We hypothesize that the combination of VR-based motor rehabilitation     protocols with concurrent anodal tDCS can boost functional recovery, and may achieve superior     effects when compared to 3 alternative treatments: 1) VR without tDCS, 2) occupational     therapy with tDCS, and 3) occupational therapy without tDCS.      The findings derived from this study will contribute to establish a novel and superior     neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke     patients. Besides the clinical impact, such achievement could have relevant socioeconomic     impact.   "
10835|NCT03144089|"     The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the     tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators     hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be     non-inferior to the Geudel oral airway in terms of expired tidal volumes.   "
10836|NCT03144076|"     In this study, the investigators use a randomized field experiment in Karnataka, India, to     measure the effects of a free inpatient public health insurance plan, Rashtriya Swasthya Bima     Yojana (RSBY), on health and poverty. RSBY is India's first large-scale national public     health insurance program, and was adopted in 2008 to cover below poverty line (BPL)     households. This study examines the impact of expanding RSBY to cover above poverty line     (APL) households that are not covered by RSBY or other secondary hospital care insurance     plans. The study will examine the impact of a public insurance program on a range of health     and economic outcomes to capture the full range of benefits from insurance. The goal of the     study is to quantify how the RSBY program benefits health and reduces poverty. Differences in     the outcomes between the treatment and control groups over the duration of the project will     measure the causal effect of health insurance on health and financial outcomes. The     investigators believe this will serve as a platform for the future of development of RSBY,     and provide further insight into the effectiveness of health insurance in low-income     countries.   "
10837|NCT03144063|"     Physicians' assessment of disease activity in SLE is fundamental but challenging. The     Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) is one of the most commonly     used disease activity indices. Clinical trials experience suggested that the disease activity     instruments did not function well on their own, and composite measures were developed to     address this issue. This approach has been adopted after learning from clinical trials that     the absence of a robust sensitive index is a major flaw when designing a trial. Another issue     with clinical trials is the confounding effect of corticosteroids, which to date have been     the most effective treatment for the management of lupus. However, unregulated use of     corticosteroids in drug trials decrease the investigator's ability to differentiate between     the tested drugs and placebo as they appear to enhance response among the placebo arm and     thus mask the effect of the tested drug.      In this study, the aim is to develop and validate a new index, SLEDAI-2K Glucocorticosteroid     Index (SLEDAI-2KG). It is very challenging to evaluate improvement in drug trials in the     context of the standard of care treatment which includes corticosteroids. This novel index,     SLEDAI-2KG, will help to overcome the confounding effect of corticosteroids and to allow for     more accurate description of disease improvement and thus facilitate accurate investigations     of new therapeutic agents.   "
10838|NCT03144050|"     This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to     measure perfusion in lower extremities and to understand how it might be used in a podiatry     clinic.   "
10839|NCT03144037|"     This is an observational trial designed to assess prospectively the adherence rate to AIs     among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant     therapy after standard local and systemic therapy. We will study adherence by administrating     the 8-item Morisky Medication Adherence Scale (MMAS - 8).   "
10840|NCT03144024|"     randomized study which include comparison rigid ring and band devices in treatment tricuspid     regurgitation.   "
10853|NCT03143855|"     The overall goal of this project is to develop initial human data on effects of novel     compounds on safety (interactions with oxycodone) and efficacy (subjective response to     oxycodone) in non-treatment seeking opioid use disorder subjects. The compound to be studied     will be the 5-HT2CR agonist lorcaserin. There are no known or reported adverse interactions     between lorcaserin and oxycodone or other opioids.   "
10854|NCT03143842|"     The purpose of this study is to investigate whether it is possible to accelerate learning and     improve memory performance in VNS implanted tinnitus participants by pairing VNS with a     verbal paired-associate learning task.   "
10855|NCT03143829|"     The purpose of the project is to estimate the effect size of a technology based intervention     for older adults with cancer for nausea and vomiting. Participants will be randomized to     either an intervention or a wait control group. Outcomes such as symptom severity, quality of     life and resource use will be examined.   "
10841|NCT03144011|"     Acute kidney injury (AKI) is a common complication in patients with congenital heart defects     after cardiopulmonary bypass (DentC.L.,MaQ., 2007, PedersenK.R., HjortdalV.E., 2008,     Zappitelli M., BernierP .L., 2009). The death rate from AKI in critically ill children     remains high and reaches 60% (FlynnJ.T., 2002).      The basic criteria for diagnosing and assessing the severity of kidney injury until recently     were the level of serum creatinine and the amount of urine released     (KDIGOclinicalpracticeguidelineforacutekidneyinjury, 2012).      However, it should be noted that the level of serum creatinine, traditionally used to assess     renal function, does not significantly increase until a decrease of more than 50% of the     glomerular filtration rate, in addition, its level depends also on some extrarenal causes.     Artificial blood circulation and hemodilution leads to the preservation of the level of     creatinine at sufficiently low levels up to 1-3 days postoperative period (ParkM.,CocaS.G.,     2010). The level of diuresis as well as the level of creatinine is a nonspecific criterion     after cardiac surgery and depends on several factors.      Currently, in the field of acute renal injury studies, progress has been made in the     emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and     insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute     renal damage in (Kashani K., Al-Khafaji A., 2013, Bihorac A., Chawla L. S., 2014. In a study     in adult patients (MeerschM.,SchmidtC., 2014), it was shown that the levels of TIMP-2 and     IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage.      Among pediatric patients with congenital heart defects, such studies are single and only     present for the age group 3 and older (MeerschM., SchmidtC., 2014), which also demonstrated     the high specificity and prognostic significance of these biomarkers in the early diagnosis     of acute renal damage.      It should also be noted that, in spite of the high specificity of the markers described, it     is also necessary to note their considerable cost.      Thus, taking into account the above, it is planned to compare and identify the relationship     of these indicators with such parameter as the index of renal vascular resistance, the     increase of which in the pre- and postoperative period may serve as a sign of the beginning     acute renal injury.   "
10843|NCT03143985|"     The purpose of this study is to see if the study drug, called TEW-7197, is safe and determine     what the best dose is to treat future patients when given in combination with pomalidomide     (POM). The study will also look to see if it has any effect on multiple myeloma, when given     in combination with POM.   "
10844|NCT03143972|"     The objective is to map the pharmacokinetic / pharmacodynamic interaction between     dexmedetomidine and remifentanil by observing changes in anesthetic depth. These changes will     be related to drug concentrations using pharmacokinetic/pharmacodynamic (PKPD) modeling.   "
10845|NCT03143959|"     The study investigates the impact of abdominoplasty in the post partum population on the     symptoms of back pain and urinary incontinence. Patients presenting for abdominoplasty fill     out validated questionnaires for both back pain (Oswestry Disability Index) and urinary     incontinence (ICIQ-UI short form). They complete the same questionnaires 6 weeks and 6 months     post op. The prospectively gathered data gives an insight into the incidence of functional     symptoms in this post partum group preop as well as the degree of improvement gained postop.     This is a multicenter trial with 9 surgeons submitting patients to the study, which ran for     19 months.   "
10846|NCT03143946|"     This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with     normal vitamin values can be increased, with vitamin suppletion and a personalized diet,     Effects of the intervention will be evaluated by quantitative analysis of blood and urine and     questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4)     and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview     will be performed.   "
10847|NCT03143933|"     It is hypothesized that propofol, when used in general anesthesia (GA) influence patient's     stress status and consequently affect stress response parameters. Hence, the objective of the     presented research is to assess whether the propofol has anti-stress effect or not in     patients undergoing surgeries that require GA and classified as The American Society of     Anesthesiologists physical status 1 (ASA PS1)   "
10848|NCT03143920|"     Pilot study to determine feasibility for treating patients with two chronic inflammatory     conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract     infections using a standardized hyperbaric oxygen treatment plan. Presently there are no good     treatments for these conditions and hyperbaric oxygen may be a safe and readily accessible     therapy as it has proven successful an another type of chronic inflammatory condition of the     urinary bladder known as radiation cystitis. The study will determine if patients will     consider this an acceptable treatment for their conditions and that it is well tolerated.   "
10849|NCT03143907|"     Recent research has suggested that mindfulness-based interventions (MBI) for psychosis may be     effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack     of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and     could lead to improvements in functioning and quality of life. MBI research to date has     primarily focused on studies of patients with chronic psychotic illness, yet relatively     little is known about the use of MBIs for youth recovering from their first episode of     psychosis. Results from recently published pilot studies appear promising in terms of the     feasibility, acceptability, and potential clinical utility (e.g., improved psychological     symptoms) of MBIs for the early psychosis population (Ashcroft et al., 2012; van der Valk et     al., 2013; Khoury et al., 2015). The current project team has completed a pilot study at the     Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences     Centre (LHSC), wherein the Mindfulness Ambassador Council (MAC), a 12-week facilitated     group intervention promoting mindfulness skills and the development of emotional and social     competencies, was shown to be an effective, feasible, and acceptable means of treating youth     in the early stages of psychotic illnesses. In follow up to the initial pilot study, the     purpose of this study is to perform a multi-site Randomized Control Trial to determine the     effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology for     transitional aged youth experiencing early psychosis. The main hypothesis, based on previous     findings on the use of MBIs in psychotic disorders, including results from our initial pilot     study at PEPP, is that youth with early psychosis who participate in the MAC group     intervention will experience a reduction in their negative and positive symptoms of psychosis     and affective symptoms compared to those receiving treatment as usual (TAU). Furthermore, we     expect that youth experiencing early psychosis who participate in MAC will have an     improvement in their quality of life, measures of recovery (self-esteem, perceived recovery),     perceived coping, assertiveness, mindfulness and cognitive skills, and a reduction in     healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of     hospitalization).   "
10850|NCT03143894|"     This study will test the preliminary efficacy of transcranial direct current stimulation     (tDCS) to improve fatigue and cognition in women with a history of breast cancer and     persistent fatigue.   "
10851|NCT03143881|"     This study evaluates the impact of a new education-based intervention on outcomes in un- and     under-insured Heart Failure (HF) patients presenting to the Emergency Department (ED) for     care. Intervention patients will receive personalized education regarding their condition,     pre- and post-testing of their HF knowledge base, and ED standard of care during the     enrollment (index) visit. Patients will then be contacted via telephone 30 days post-index     visit for re-testing and reinforcement of previously learned material. Patients in the     control group will receive ED standard of care.   "
10852|NCT03143868|"     This study plans to learn more about how type of exercise influences measures of appetite     regulation. In this study investigators will be evaluating a resistance exercise session     (using weight machines and free weights) and an aerobic exercise session (using a treadmill).     Participants will also complete a sedentary control condition.   "
10856|NCT03143816|"     This is an investigator-initiated, prospective, randomized, multicenter, parallel,     open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and     time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting     insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life     study where patients will continue their routine diabetes care and use post-meal correction     dosages as deemed necessary for normalizing PPBG as per the protocol.      This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The     patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized     into the NL arm will continue using their usual prandial insulin dose before meals. Patients     who are randomized into the TI arm will be instructed to dose before the meals and take     necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will     be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone     visits). There will be a 4-week treatment comparison between TI and NL and 1-week of     post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic     panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.      All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at     the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at     every clinic visit on a secured computer. The data will be analyzed after the study for     different primary and secondary end points. All patients will be allowed to keep the CGM     after the study is over for their day-to-day diabetes care.   "
10857|NCT03143803|"     The aim of the study is to get insight into control of glycemic variability with Sugar     Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg,     bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus     rosea)-20mg.   "
10858|NCT03143790|"     Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate     erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the     treatment also applies to men with moderate to severe erectile dysfunction after nerve injury     associated with prostatectomy.   "
10859|NCT03143777|"     This study investigates the impact of introducing an early mobilisation device called the     Sara Combilizer on time taken to mobilise in critical care. The investigators will collect     baseline data on time taken to mobilise for a period of 4 months, then following a training     programme and introduction of the device for a further 4 months   "
10860|NCT03143764|"     This study aimed to examine cycling time and distance when inactive subjects were provided     with electrically assisted bicycles, and secondly, to examine changes in cardiorespiratory     fitness.   "
10945|NCT03142646|"     Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19     Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.   "
10946|NCT03142633|"     The aim of this study is to explore the microRNA profile in serum of women with Polycystic     Ovary Syndrome and investigate the correlation between the microRNA profile and markers of     metabolic syndrome.   "
10861|NCT03143751|"     Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability.     Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI.     Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the     treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves     long term outcomes is uncertain. The aim of the current study is to assess the efficiency and     the safety of continuous hyperosmolar therapy in TBI patients.      The COBI trial is the first randomized controlled trial powered to investigate whether     continuous hyperosmolar therapy in TBI patients improve long term recovery.      Hypothesis      Patients treated with early continuous hyperosmolar therapy have reduced morbidity and     mortality rates compared to those receiving standard care alone after traumatic brain injury.      Research Questions        1. Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and          6 months after TBI assessed by the GOSE questionnaire?        2. Does early continuous hyperosmolar therapy prevent intracranial hypertension?   "
10862|NCT03143738|"     Comparison of continuous adductor canal block to continuous femoral nerve block in patients     after total knee arthroplasty.      All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine     with a catheter implemented to the adductor canal or next to the femoral nerve.      The observed goals: pain intensity, the beginning and quality of rehabilitation.   "
10863|NCT03143725|"     This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose     treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet     relative to an oral solution and to the oral direct compression (DC) tablet after single dose     intake in healthy male subjects and to evaluate the effect of food on the bioavailability of     the WG oral tablet.   "
10864|NCT03143712|"     This study is a Phase I, randomized, open-label, cross-over study with three single-dose     treatments to compare the bioavailability of an oral tablet relative to an oral capsule of     GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food     on the bioavailability of the oral tablet.   "
10865|NCT03143699|"     The present study aims to investigate the effect of immediate feedback on long-term blood     pressure measurement skills. This is a randomized controlled trial including first year     students from a Brazilian medical school, which will be randomized in two groups: an     intervention group (submitted to a training on blood pressure measurement skills and an     immediate feedback) and a control group (submitted to a training on blood pressure     measurement skills, but with no immediate feedback). Then, students will be assessed 3 months     after the feedback in order to see whether there will be a difference between groups. Our     hypothesis is that students submitted to immediate feedback would have better scores in the     blood-pressure measurement skills after 3 months. A knowledge questionnaire as well as a     standardized patient scenario will be used to assess students' knowledge and skills.   "
10866|NCT03143686|"     Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery     System implantation in patients presenting severe symptomatic aortic stenosis to provide     safety surveillance of the device.   "
10867|NCT03143673|"     The purpose of this study is to evaluate safety of the study device and study device     performance in patients presenting with severe aortic stenosis who are considered to be high     risk for open surgical repair.   "
10869|NCT03143647|"     Magnesium has built up the reputation of a 'natural calcium antagonist'. However, the exact     effect of magnesium on coagulation and more specifically on platelet function is still     disputed. An important discrepancy between in vivo and in vitro studies exists. Magnesium has     thus been reported to antagonize platelets in some studies, and to stimulate platelets in     other studies. Current evidence seems to point in the direction of a general antagonization     of aggregation and coagulation.      Intravenous magnesium is often administered in pre-eclampsia as seizure prophylaxis.     Therapeutic regimens usually consist of an intravenously administered loading dose (2-3     grams) and a maintenance infusion, targeting a plasma level of 2-3 mmol/L. Therapeutic drug     monitoring is needed, as magnesium toxicity is an important concern.   "
10870|NCT03143634|"     Currently, our best psychological treatments for anxiety and mood disorders only focus on     individual diagnoses. So, there are separate treatments for Panic Disorder, or Depressive     Disorder, or Social Anxiety, etc. These 'diagnosis-specific' treatments work well for people     whose problems fit neatly into a single diagnosis. However, they work far less well for     people with complex problems involving multiple diagnoses, and 50% of patients fail to     respond well to these existing treatments.      The purpose of this study is to test a new psychological treatment for anxiety and mood     problems (the Modular Protocol for Mental Health [MPMH]). Instead of focusing on any single     diagnosis, MPMH combines the best treatment techniques into 10 modules to target problems     common across all of the different mood and anxiety diagnoses (e.g., intense emotions,     negative thinking, upsetting memories, distressing habits). MPMH should therefore be a better     treatment for the large numbers of individuals whose problems do not fit neatly into a single     diagnosis and for whom any treatments targeting a single diagnosis would leave significant     difficulties unaddressed.   "
10872|NCT03143608|"     The investigators prospectively studied ninety nine GERD patients following laparoscopic     hiatal surgery combined with transoral incisionless fundoplication at two community     hospitals. General surgeons and gastroenterologists participated in the study. GERD questions     were recorded before and at six and twelve months.   "
10873|NCT03143595|"     Preexisting cognitive impairment, such as mild cognitive impairment, is common in many     elderly patients who undergoing major surgeries. Accumulating evidence has demonstrated that     preexisting cognitive impairment is associated with increased mortality, increased incidence     of postoperative complications, decreased quality of life, and worse outcomes. However, few     studies have evaluated the relationship between preexisting cognitive impairment and     cognitive trajectories and clinical outcomes.   "
10874|NCT03143582|"     The investigators are interested in finding accessible interventions for youth and young     adults that help promote long-term positive mental health functioning. They will be     investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on     mental health symptoms, memory, and attention. This intervention will hopefully improve     mental health functioning in youth aged 17-25 that are at high risk of developing mental     health disorders. Sessions will consist of 30 minutes of running under the supervision of     group leaders and coaches. The group will steadily increase the distance and time spent     running versus walking, with the goal of having everyone run a 5 km race together at the end     of 13 weeks. Once a week, youth will be provided with education on a variety of topics     related to health and running. Youth will complete measures before, during, and after the     program to assess outcomes.   "
10875|NCT03143569|"     This study evaluates two different methods for monitoring a patient's anti-clotting [heparin]     therapy after they receive a heart pump implant [left ventricular assist device -LVAD]. One     method tests for how long it takes the patient's blood to clot and uses that to determine if     they are on the right dose of heparin. The other method uses a more direct measure of how     much heparin is in the blood. The hypothesis is that the method that more directly measures     how much heparin is in the patient's blood will provide better medical results for the     patient's care after they have the heart pump implant. To that end, the investigators are     conducting this feasibility trial to establish the logistics associated with the     implementation of these heparin monitoring approaches.   "
10876|NCT03143556|"     This is a pilot, single-centre, feasibility study to assess the feasibility issues and     collect preliminary clinical data for the design of future randomized controlled trial to     evaluate the feasibility and patient comfort of magnetic retrieval device removal of ureteral     stent in transplant patients.   "
10877|NCT03143543|"     The purpose of Project 2 is to execute phase I functional magnetic resonance imaging (fMRI)     studies to assess the effects of lorcaserin on brain target engagement (measured by fMRI     brain activation and neural connectivity) in cocaine use disorder (CocUD) subjects and/or     opioid use disorder.   "
10878|NCT03143530|"     The pectoralis block, including pecs I and II block, is a novel technique first described in     2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The     research goal is to determine the efficacy of the pectoralis block compared to placebo in     improving quality of recovery following mastectomy.   "
10879|NCT03143517|"     The primary objective is to obtain stool samples from subjects with symptoms of an     undiagnosed gastrointestinal disorder. All subjects enrolled in the study will undergo a     colonoscopy.   "
10886|NCT03143426|"     Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal     surgery in Western countries. Ever since the introduction of laparoscopic surgery in the late     1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the     introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed     due to the early experience and safety profile seen in LC.      The introduction of stereoscopes which allow for 3D visual feedback has been postulated to     overcome setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since     its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over     2D visualisation, especially so within the context of training junior surgeons in controlled,     experimental settings. The body of evidence on benefits of 3D visualisation within the     clinical setting, i.e. when applied on live patients in operating theatres, remains small and     weak. The previous publications however did not extrapolate any potential benefits on     patients' well-being in correlation to their reported benefits and neither did they explore     any potential benefits in reducing operative complications.      We decided to embark on a study to investigate any peri-operative advantage conferred on     junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu     Hospital are carried out by junior surgeons.   "
10880|NCT03143504|"     Eczema is a chronic disease of the skin that is becoming more common worldwide for reasons     unknown. Currently the best indicator that a baby will suffer from eczema is if either or     both parents have the condition, although this is not always the case. The goal of this study     is to find out if, from birth, the skin of babies who later go on to suffer from eczema     develops differently to those who do not. By doing this the research team hope to detect     early signs of the disease within the first year of life. Our researchers will ask 150     families from the local Sheffield community to take part in a 1-year study.      To monitor baby skin development, the investigators will carry out 3 simple procedures at the     skin surface that pose no risk to the baby. These procedures will be performed on the arm and     thigh, at birth, 4 weeks, and 12 months of age. In addition the investigators will ask     parents to answer questionnaires and fill out diaries at specific time points throughout the     year, to collect information on how they care for their baby's skin. By recording which     babies go on to, and do not, develop eczema the investigators hope to: (1) better understand     baby skin development from birth, (2) identify if these simple procedures can predict the     development of eczema during the first 12 months of life, and (3) investigate environmental     effects that may cause disease onset. In a medical era where the prevention of eczema is the     long-term goal, it is hoped that this study will provide a new way to identify babies that     may go on to develop eczema. This will allow healthcare professionals to offer specific skin     care advice from birth, and empower parents to take measured action to help prevent the     emergence of eczema in their baby.   "
10881|NCT03143491|"     This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and     preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%)     applied topically once per week for four weeks to the ectocervix of subjects with high grade     cervical intraepithelial neoplasia (CIN).   "
10882|NCT03143478|"     About 150,000 people in the UK suffer a stroke each year and ~60% with moderate to severe     stroke fail to recover arm or hand use. Stroke rehabilitation is increasingly home-based     following early supported discharge (ESD) from hospital to facilitate self-management and     avoid problems associated with prolonged hospital stays. There is strong evidence that     intensive practice and re-education of normal movement is essential for functional motor     recovery, hence the NHS guideline of 45 minutes therapy 5 days per week, but NHS Trusts have     difficulty meeting this target due to cost and access to specialist therapists.      An M-MARK Mk1 device that combines an Inertial Measurement Unit (IMU) with an     Mechanomyography (MMG) sensor has been designed and laboratory tested. Novel signal     processing techniques have been demonstrated that reduce problems of vibration artifacts and     generate information on mechanical muscle activity and movement. The aim of the overall     M-MARK project is to develop a low-cost wearable wireless device (Mk2) that patients can use     independently at home while practicing standardised everyday activities to regain upper limb     function. Mk2 M-MARK has now been developed in collaboration with therapists, patients and     their carers. The system incorporates feedback, presented on a computer/tablet, as motivating     visualisations of movement showing them if they have moved in the correct way. A separate     interface has been developed for therapists, which offers a simple system to diagnose     specific movement problems to inform clinical decision-making, monitor progress and thus     increase efficiency of therapy.      In phase 1 of this study, user requirements were assessed to inform the development of the     Mk2 M-MARK for clinical use. Ten patients and carers were interviewed and 20 health     professionals took part in two focus groups, from Portsmouth Hospitals NHS trust and North     Bristol NHS Trust. The Mk2 system has now been developed, reliability demonstrated and     iterative testing with stroke patients has ensured usability of the system.      This phase of research will examine the clinical feasibility of using Mk2 M-MARK with stroke     patients who are undergoing early supported discharge. All feasibility aspects of the     wearable system will be assessed including usability and safety. Preliminary data on efficacy     will be collected and a health economics analysis will be undertaken.   "
10883|NCT03143465|"     Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and     ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental     questions of migraine, which remains to be elucidated, is the mechanism behind the generation     of migraine attacks.      We will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers     of migraine, combined with advanced neuroimaging techniques, to investigate the attack     initiating pathophysiology.      Both substances have previously been administered to healthy participants and migraine     without aura patients, inducing headache and migraine-like-attacks.      We hope to contribute with novelty to the current understanding of the migraine     pathophysiology and development of more efficient treatment of migraine.   "
10884|NCT03143452|"     This study aimed to compare the efficacy between 2% lidocaine gel vs 0.5% tetracaine eye drop     as topical anesthesia in phacoemulsification   "
10885|NCT03143439|"     The Urban Institute—a nonprofit, nonpartisan research organization—is partnering with Rubicon     Programs to conduct a rigorous evaluation of its Fathers Advancing Communities Together     (FACT) program. FACT is a multi-faceted program designed to deliver responsible parenting,     healthy relationships, and economic stability services on a voluntary basis to low-income     fathers in Contra Costa County, California. Urban's evaluation comprised of three key     components:      The implementation evaluation will describe FACT program activities and services, including     communication and coordination across partners, service delivery mechanisms, and whether and     how participants and their families received comprehensive services. Urban will identify a     logic model for the program and assess the barriers to and facilitators of program     performance. The implementation evaluation will draw from interviews with program staff,     partners, and stakeholders, as well as field observations, program and administrative data,     and focus groups with FACT participants and their families.      The outcome evaluation will build on the implementation evaluation to determine whether     specific program components, their frequency, and their duration, are related to outcomes.     Urban will conduct surveys of program participants at the time of their enrollment into the     program and one year following their enrollment to explore how participants' self-reported     attitudes on various domains are associated with economic self-sufficiency and family     functioning. Urban will also use program and administrative data collected by Rubicon and its     partners, specifically Rubicon's case management database, to assess participant outcomes.      The impact evaluation will assess to what extent participation in the FACT program is     associated with improved outcomes as compared to similarly situated individuals who did not     participate in the program. Urban will work with Rubicon's partners to identify individuals     living in Contra Costa County who were eligible to participate in the program but, for     whatever reason, did not do so. Once a comparison group of fathers has been established,     Urban will use individual-level outcome data to determine whether the FACT program has an     impact on economic self-sufficiency and family functioning.   "
10887|NCT03143413|"     Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and     characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal     syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome     is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia)     and / or mouth (xerostomia). It may be primary or secondary to another connective tissue     disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated     to classify the SS but require a labial salivary gland biopsy, invasive act which     complications can sometimes be reported (hematoma, lip sensory defect).      Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands     were developed but no studies have evaluated ultrasound abnormalities of salivary glands in     patients with systemic sclerosis.   "
11823|NCT03131141|"     This is a single-centre, open-label, non-randomized, single dose study in healthy male     subjects designed to assess mass balance recovery, metabolite profile and metabolite     identification of radio-labeled BC-3781 administered via the intravenous or oral routes.   "
10890|NCT03143374|"     The purpose of this study is to measure the amount of a protein in the brain known as tau     using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown     to build up in the brains of patients with injury to brain cells, including Alzheimer's     disease (AD), Parkinson's disease (PD), Lewy body disease (DLB) and Frontotemporal     degeneration (FTD).   "
10891|NCT03143361|"     Clinical evidence in aortic valve surgery is mainly due to retrospective, single-center     studies. This can be a significant limitation in the analysis of the critical factors in the     treatment of patients affected by severe aortic stenosis. In order to avoid these     methodological limitations, the investigators have planned a European, multicenter,     prospective on surgical aortic valve replacement (both traditional and innovative     techniques), the E-AVR registry.      This registry will collect prospective data from 19 cardiac surgery centers in university or     regional hospitals in seven European countries (England, Italy, Finland, France, Germany,     Spain, Sweden, and Switzerland) and will form an observatory on the real world of everyday     practice aortic valvular surgery, both with traditional and innovative approaches.      The main objective to pursue is that the E-AVR register can provide valid data to identify     risk factors and strategies associated with sub-optimal results in the various aortic valve     replacement techniques. This information can improve the safety and durability of aortic     valve replacement. In addition, the proposed identification and classification of     postoperative complications can become a valuable research tool to stratify the impact of     these complications on the results of these patients and evaluate the load of the resources     needed for their treatment.   "
10892|NCT03143348|"     This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery.     The investigators want to learn more about the inflammation that exposure to bypass creates     in the body by studying markers of inflammation and cell injury in the bloodstream.     Additionally, the investigators want to examine if these markers can predict which babies     develop post-surgical complications. The hypothesis is that babies who undergo bypass will     have higher levels of these markers than babies not exposed to bypass and that these markers     will correlate with how the baby does clinically after surgery.      This study will evaluate markers via blood sampling in babies with congenital heart disease     who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that     undergo surgery with bypass. The overall goal is that this study will lead to useful     biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for     babies who require heart-lung bypass.   "
10893|NCT03143335|"     The purpose of this study is to examine different outcomes of breast reconstruction in women     who are treated for breast cancer with skin sparing mastectomy and subsequently a primary     implant based reconstruction by one of two different techniques with either a pre- or     retropectoral placement of the implant.      The main objective of the study is to establish whether one of these techniques may result in     a superior outcome and thus should be recommended as first choice treatment rather than the     other.   "
10894|NCT03143322|"     Bone metastases occur frequently during the evolution of solid tumors, either isolated or     associated with visceral metastases. The incidence varies between 20 and 85% depending on the     primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone     metastases. Cancer with bone metastases compared to other metastatic sites is considered as     associated with a better prognosis, particularly for breast and prostate cancer. Bone     metastases may be present at diagnosis (synchronous metastasis) or appear at a later time     (metachronous metastasis).      The concept of oligometastases was proposed in patients with about 3 up to 5 metastases     (without restriction on the primary site) and associated with an intermediate prognosis. It     was hypothesized that local treatment with curative intent, aiming at the few metastatic     sites, would yield long-term survival probabilities, along with systemic therapies.      Long-term survivors have been reported after curative-intent treatment of metastasis in     sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone     metastasis because of their high incidence, their impact on the patient's quality of life and     autonomy, and their accessibility to potentially curative radiotherapy.      The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate     cancer), biologically-targeted drugs and chemotherapy (all cancers).      Stereotactic radiotherapy is a highly accurate technique was initially developed for     performing the radiosurgery of brain tumors in patients for whom it was deemed be too     difficult to proceed to classical excision surgery. In this process, a high total dose of     radiation is delivered in a single fraction to a well-defined intra-cranial target. The     concept of radiotherapy in stereotactic conditions was extended to one or several fractions     delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic     Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung     metastases. Similarly, very high local control rates have been reported in bone metastases     after stereotactic radiotherapy.      In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high     doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1     and 3 metastases) in solid tumor patients is able to improve the survival without     progression.   "
10895|NCT03143309|"     This study is a parallel group randomized controlled trial among female university students     designed to test the effect of a physical activity intervention on daily walking. Both groups     will receive messages 2-3 times per week via WhatsApp. Intervention group will receive     orientation and wear a pedometer for the study period. The follow-up duration is 3 months.   "
10896|NCT03143296|"     The purpose of this study is to investigate speech understanding in simulated reverberant     environments with MED-EL cochlear implant recipients.   "
10897|NCT03143283|"     The National Action Alliance to Prevent Suicide recently released a research agenda aimed at     significantly reducing suicide over the next decade. Aspirational Goal 12, Reduce access to     lethal means that people use to attempt suicide, calls for identifying effective strategies     to reduce a suicidal person's access to firearms and other lethal means.      A promising strategy is to counsel patients seen in the emergency department (ED) for a     psychiatric emergency to reduce access to firearms (the most lethal suicide method) and     medications (the most common method of suicide attempt). To date, however, few studies have     evaluated changes in firearm storage practices among those who received lethal means     counseling (LMC), and those that have, including a pilot conducted in Colorado by the study     team, have lacked control groups. Results from the pilot, which provided emergency department     based LMC counseling to parents of suicidal adolescents, found that among gun-owning parents,     33% had unlocked guns at home on the day of the ED visit and none did on follow up.      Using the piloted LMC protocol, we will conduct the first randomized, controlled trial (RCT)     of the effectiveness of ED-based LMC on firearm and medication storage. The proposed RCT, to     be conducted in five Colorado hospitals, will test whether parents of at-risk adolescents who     are treated in hospitals that have (vs. have not yet) implemented our LMC protocol are more     likely to store household firearms and medications safely. In addition, we will conduct     in-depth, qualitative interviews with parents who have received LMC counseling to better     understand those factors that affect parents' willingness and ability to make changes to     firearm and medication storage. We will also conduct qualitative interviews with clinicians     to understand factors affecting clinician engagement in LMC.      AIM 1: To assess the effectiveness of an ED-based LMC intervention to improve how parents of     pediatric patients (age 10-17) who visit the ED for a mental health emergency store household     firearms and medication.      AIM 2: To examine how attitudinal and contextual factors shape a) parents' decisions about     firearm and medication storage following LMC, and b) clinicians' delivery of LMC messages.   "
10898|NCT03143270|"     The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead     Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.   "
11824|NCT03131128|"     The present study will carry out a workplace health promotion via MBI with lessons of dietary     behavior to help overweight or obese workers to loss weight.   "
10901|NCT03143231|"     Background: Bronchiolitis is one of the most common and costly respiratory diseases in     infants and young children. Despite the high prevalence and morbidity of bronchiolitis,     therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation     remains the cornerstone of therapy for these infants.      Over the past 2 decades, research on bronchiolitis management has explored the use of     nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary     clearance, as well as reduce airway edema.      Aim:The aim of this study is to investigate whether the addition of frequently nebulized     hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill     infants hospitalized with bronchiolitis.   "
10902|NCT03143218|"     A double-blind, individual randomised trial will be undertaken in 6000 children under the age     of five years living in areas of Burkina Faso or Mali where the transmission of malaria is     intense and highly seasonal to determine whether the malaria vaccine RTS,S/AS01 is (a) as     effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful     protection when given together with SMC. The primary trial end-point will be the incidence of     clinical episodes of malaria detected by passive case detection. The costs of each     intervention and its delivery will be determined and compared   "
10905|NCT03143179|"     The immediate period after spinal cord injury (SCI) is one of the only opportunities that     clinicians and care-givers have to make a real difference to patient outcomes. One of the     main aims during this period is to preserve blood flow and oxygen delivery to the spinal cord     to prevent any further damage from occurring after the injury. The heart acts as the major     pump for blood to be pumped to the spinal cord and the body. It has been shown in small     animal models and in humans with long-standing SCI that the ability of the heart to pump     blood after injury is compromised, which may in turn reduce the amount of blood and oxygen     delivered to the injured cord. It is unclear how quickly these changes occur in the heart     following SCI and how best to manage heart function such that blood flow and oxygen delivery     can be optimized. In the present study, the investigators will examine how the heart     functions immediately after SCI. The findings from this study are expected to provide new     information that could help clinicians improve the management of people who have just     suffered a SCI.   "
10906|NCT03143166|"     The primary objective of this trial is to investigate the relative Bioavailability [BA] of     tablet formulation of Dabigatran etexilate [DE] with and without co-administration of     rabeprazole in healthy male subjects.      The secondary objective is the evaluation and comparison of several pharmacokinetic     parameters between the treatments.   "
10907|NCT03143153|"     The main purpose of this study is to compare how long subjects with esophageal cancer live     overall or live without disease progression after receiving nivolumab and ipilimumab or     nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin   "
10908|NCT03143140|"     To evaluate a novel technique—ultrasound guided percutaneous abaltion of tumor feeding artery     before RFA for liver malignancy.   "
10909|NCT03143114|"     The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the     fertility outcomes in infertile women.   "
10910|NCT03143101|"     This study is being conducted to compare the immunogenicity, safety, and viral shedding of a     new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the     2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine     in the 2015-2016 influenza season.   "
10911|NCT03143088|"     Obtaining vital signs and blood pressure (BP) in particularly, as part of a pediatric     Emergency Department (ED) patient triage is sometimes difficult and leads to many false     negative results.      The stress, noisy environment and lack of cooperation are only a few of the things that     interfere with a proper vital signs measurements.      In the past decade, there has been a rapid growth in the presence of therapeutic clowns in     hospitals, particularly in pediatric settings.      we speculate that the incorporation of a medical clone during the procedure of blood pressure     measurement in the triage will shorten the procedure and decrease the number of attempts,     making it much more efficient.   "
10912|NCT03143075|"     In this study, the investigators will stratify depressed subjects a priori based on CRP     levels to test the hypothesis that eicosapentaenoic (EPA) would be more efficacious to treat     depression in subjects with high CRP levels compared to subjects with low CRP levels.      Depressed subjects, with ongoing stabilized antidepressive treatment who remain clinically     depressed, will be enrolled in an Inflammation group or in a Non-inflammation group     depending on baseline levels of CRP. Subjects in both groups will receive EPA enriched     omega-3 fatty acids for 8 weeks, added to their pre-stabilized antidepressant medication.   "
10913|NCT03143062|"     To this date no clinical evaluation reports of the dynamics in the National Early Warning     Score (NEWS) for those patients who suffer an in-hospital cardiac arrest, IHCA, exists. This     process needs to be investigated in order to optimize the future care of these patients.      Research Questions H1: Patients that suffer an IHCA has had higher NEWS in the preceding 24     hours from the event compared to those who did not suffer an IHCA.      H2: There is a parameter in the NEWS that could predict IHCA better than the others in the     preceding 24 hours.   "
10914|NCT03143049|"     Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have     survival of less than 1 year. Recently, a randomized study of Pomalidomide and dexamethasone     conducted in compared with placebo and dexamethasone showed that pomalidomide can improve     survival of this group of patients. As a result, pomalidomide is now approved by the FDA and     EMA for use in patients with relapsed/refractory myeloma previously treated with bortezomib     and lenalidomide. We have conducted a study using Pomalidomide plus Dexamethasone (PD) in     Asian patients, which showed good efficacy and safety profile. More important for patients     with suboptimal response to PD will achieve a clinically meaningful response with the     addition of oral cyclophosphamide (PCD). In the United States, a small randomised phase 2     study of PCD versus PD showed that PCD have a higher response rates, produce deeper response     and correspondingly longer progression free survival. There is till date no randomised phase     3 study between these regimens. This will be important to determine what is the best     combination including pomalidomide for use in relapse myeloma.   "
11880|NCT03130400|"     There is no study to explore the prediction of knee diseases using kinematic parameters of     knee during gait. The aim of this study is to explore the possibility of predicting knee     diseases by gait parameters.   "
10915|NCT03143036|"     Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have     survival of less than 1 year. A number of new drugs have been approved for the treatment of     relapse myeloma in the last couple of years, including, Elotuzumab, Panobinostat, Ixazomib,     carfilzomib and Pomalidomide. However, most of these drugs either do not have good single     agent activity or still belongs to the category of immunomodulatory drugs or proteasome     inhibitors. Daratumumab is a monoclonal antibody against CD38 that is highly expressed on     myeloma plasma cells. In phase ½ studies, it has impressive single agent activity in relapse     and refractory myeloma with a very acceptable toxicity profile. This set the stage for     combinations with daratumumab to increase efficacy and improve outcome of patients with     myeloma. The use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been     shown to augment NK cell activity. NK cells are important mediator of antibody dependent     cellular cytotoxicity. We therefore hypothesize that the combination of Daratumumab with     thalidomide may therefore improve the efficacy of the treatment.      In this study, we will plan to perform a phase II trial using the Daratumumab, Thalidomide,     Dexamethasone combination in 100 myeloma patients with relapse myeloma in Asia.   "
10916|NCT03143023|"     This study will be conducted to evaluate the effect of arginine versus fluoride containing     toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult     population using chair side assessment method.   "
10919|NCT03142984|"     The skin of a newborn has a sensitive skin barrier relative to an older child and an adult.     Newborn's skin, for example, is extremely vulnerable to damage by environmental agents such     as harsh detergents, some topical oils, and other irritant chemicals. Evolving perspectives     on barrier dysfunction in newborn babies has led to the idea that there may be a window of     opportunity in the first few months of a newborn's life to change the environmental agents     that their skin is exposed to in order to maximize skin health. These environmental changes     could involve the use of optimally formulated wash products and emollients, as well as the     removal of all other irritant substances that could damage the skin barrier. Further research     is required to identify skincare practices that are harmful and those that are positive, and     to ultimately ascertain what the optimum skincare routine should be.      An important skincare strategy is to identify an appropriate regimen (use of topical     emollients and wash products) that will be used to maintain healthy skin in the future. Baby     massage in particular has been shown to enhance the bond between mother and newborn,     highlighting that early intervention can support skin health while also being a rewarding     experience.      Gentle Touch/Early Massage:      Apply the lotion with a gentle touch to communicate love to your baby and to create a special     bonding moment with skin-to-skin touch. Your touch nur-tures baby's social, emotional and     physical development. Please take your time to apply consciously the lotion on the whole body     of your baby while engaging with her/him. Your touch, light but present, will be consistent     across all the face and body areas, it is delicate and soft but more than just applying the     lotion.      Parents/guardians are using products to help care for their newborn's skin and there is a     need to help parents/guardians identify the most appropriate products through research. This     study aims to help address this need.   "
10920|NCT03142971|"     The aim of this randomized controlled study is to investigate if focal shock wave is an     effective treatment, with respect to hip pain and lower limb function, in a population     affected by greater trochanteric pain syndrome with gluteal tendinopathy.   "
10921|NCT03142958|"     A post market, prospective, non-randomized, multi-center, open-label,clinical study using     survivorship as the reference performance goal to study the safety and efficacy of the     Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.   "
10922|NCT03142945|"     In addition to manual therapy, mobilizations, manipulations, and exercise, the McKenzie     method of Mechanical Diagnosis and Therapy (MDT) is currently being used to treat headaches.     However, there is little supportive evidence about the efficacy of this type of treatment.     The MDT method focuses on actively involving the patient in education and self-management of     pain. The focus is to have the patient learn about his/her condition and how to manage the     symptoms independently when possible.      With regards to research that has been conducted on the use of MDT with headaches, one study     compared mechanical traction, rhythmic impulse, and MDT exercises in relieving tension-type     headaches (TTH). Mechanical cervical traction was found to be more effective at reducing     headaches in both infrequent episodic and frequent episodic TTH. While MDT was used in this     study, a general treatment was prescribed to each patient in that group without consideration     to directional preference. This treatment had the patients perform the same exercises in the     same progression, including four extension exercises, one flexion exercise, two lateral     flexion exercise, and one rotation exercise. In addition, they performed the exercises for     the same length of time for the same number of repetitions. The study was unclear about     whether the exercises were administered by physical therapists or whether the practitioners     were MDT credentialed.      One case study described the treatment of a cervicogenic headache using the MDT retraction     progression along with therapeutic exercises that included deep neck flexor and extensor     strengthening and stretching of neck musculature as indicated . The patient reported that     performing retractions at home provided him relief from his headaches for progressively     longer periods of time as his treatment progressed. By the end of the treatment, the patient     no longer experienced headaches. The results from this article support the proposition that     headaches which present with mechanical origins can be successfully treated with the MDT     approach.   "
10923|NCT03142932|"     The objective of this study is to conduct a randomized controlled trial to determine whether     the use of the COach2Quit application (app) reduces smoking more than brief advice for     smoking cessation. The investigators hypothesize that real time biomarker feedback and     messaging support from the COach2Quit app will lead to greater smoking cessation rates than     brief anti-smoking advice alone. If effective, the COach2Quit app could be an easily     accessible and cost-effective tool to help smokers quit. The findings from this trial could     have implications for the delivery of future outpatient smoking cessation programs.   "
10924|NCT03142919|"     LPS Challenge in Individuals with Major Depressive Disorder   "
10925|NCT03142906|"     The goal of this study is to assess the impact of perioperative point-of-care ultrasound     (POCUS) assessment on patient-important outcomes (e.g. hospital length of stay, length of     stay in recovery, mortality etc.) and perioperative patient management strategies, in     patients undergoing non-elective non-cardiac surgeries.   "
10926|NCT03142893|"     The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA     axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal     axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also     examine the cognitive function associated with sleep restriction, including food intake and     food cravings.   "
10933|NCT03142802|"     Patients with primary germ cell cancer of the testicles confined to the testis can avoid     adjuvant treatment by entering a surveillance protocol. In the surveillance protocol,     patients are followed for up to ten years with serial computed tomography scans to detect     recurrence. Multiple CT scans expose patients to a significant amount of radiation, which may     be associated with an increased risk of secondary malignancies. This study hypothesizes that     low dose CT scans are as effective as standard dose CT scans in detecting disease recurrence     in this setting and will significantly reduce radiation exposure in this group of patients.   "
11697|NCT03132805|"     In this study, the investigators propose to examine whether the combination of a universal,     elementary school-based preventive intervention with an indicated preventive and treatment     intervention would yield greater impact on aggression than the universal preventive     intervention alone.   "
10927|NCT03142880|"     BACKGROUND: One previous study has confirmed that the marginally hyperbaric solutions of     bupivacaine can maintain good quality of anesthesia and get a more steadily hemodynamic     status than commonly hyperbaric solutions, some authors confirmed the plain ropivacaine for     cesarean section have a higher failure rate and commonly hyperbaric solutions of ropivacaine     have a higher incidence of side reaction. It is unclear what the efficacy of spinal     marginally hyperbaric ropivacaine for elective cesarean delivery.We hypothesized that the     marginally hyperbaric ropivacaine will get a similar efficacy to commonly hyperbaric     solutions but a more steadily hemodynamic status.      OBJECTIVE In this prospective, randomized, double-blinded study, Investigator will compare     the clinical efficacy and adverse effect of spinal anesthesia with commonly hyperbaric and     marginally hyperbaric ropivacaine for elective cesarean delivery.      Main outcome measures: The maximum cephalad sensory block level; the change of continuous     cerebral oxygen desaturation (ScO2) over time; the incidence of hypotension and nausea and     vomiting; the change of invasive arterial pressure; the consumption of ephedrine; the     incidence of shivering; the onset time to T8 dermatome; the quality of anesthesia (efficacy     of motor block and sensory block)   "
10940|NCT03142711|"     Systemic lupus erythematosus (SLE) may involve a variety of organ systems expressed     differently from patient to patient, and so can be difficult to characterize clinically.     Patient reported outcomes (PROs), which consist of feedback directly from patients regarding     their symptoms without interpretation by a clinician, are typically used in SLE to supplement     other clinical measures. Standard PROs typically used in SLE include the 36-item short form     health survey (SF-36), the functional assessment of chronic illness therapy - fatigue     (FACIT-F), and the patient global assessment (PtGA), administered by paper or electronic     tablet during the clinic visits. The recent development of electronic mobile device     technology, such as the smartphone, has made it possible to collect PRO information away from     the clinical site in the subject's environment. This study will assess by measurement     equivalence testing whether data collected via a smartphone are comparable to that collected     in standard fashion and whether PROs obtained in the subject's environment may be more     informative than that collected in the physician's office on paper.   "
10928|NCT03142867|"     Nonalcoholic fatty liver disease (NAFLD) is a global health concern with a suspected     increasing prevalence due to the rise in obesity and diabetes mellitus. The vast majority of     patients will have isolated steatosis or steatosis with mild inflammation that is very     unlikely to progress in severity. However, about 25% of patients with NAFLD have     non-alcoholic steatohepatitis (NASH), the more aggressive form of the disease that is     associated with fibrosis progression and potential risk for cirrhosis and end-stage liver     disease complications. Additionally, multiple studies have demonstrated an association     between NAFLD and the presence of coronary artery disease by either coronary CT angiography     (CCTA) or coronary artery calcium (CAC) score. Cardiovascular disease is the most important     cause of mortality in patients with the entire spectrum of NAFLD. In the era of advanced     imaging and functional vascular assessment it is possible that novel risk assessments are     poised to refine overall prognostic estimation in this population. Multiple analyses have     suggested that NAFLD is an independent and strong predictor of significant CAD independent of     cardiovascular risk factors, including a significant burden of high risk CCTA findings in one     analysis of symptomatic patients in the emergency department. Given the multiple metabolic     derangements inherent in the NAFLD population, endothelial dysfunction is also an important     contributor to global cardiovascular dysfunction. Furthermore, data suggests that patients     with NAFLD may be at increased risk of adenomatous polyp formation and colorectal     adenocarcinoma. In addition, it is suboptimal to require a liver biopsy to diagnose NASH.     Recent imaging advances have made it possible to assess liver fibrosis but have yet to be     fully studied in NAFLD. The purpose of this study is to assess the current prevalence and     severity of NAFLD in adult subjects. Secondary endpoints include correlation to new vascular     function (cine scan of the abdominal aorta) and echocardiographic imaging modalities     available at BAMC and to circulating biomarker panels as well as to determine the prevalence     and severity of CAD by multidetector coronary CT angiography with subject outcomes being     monitored prospectively. Additionally, correlation of NAFLD diagnosis to colonoscopy findings     will be performed.   "
10929|NCT03142854|"     About 30% of patients were reported to suffer inadequate bowel preparation. So, it is     desirable to prescribe personalized regimen according to patient's personal characteristics.   "
10930|NCT03142841|"     This research study will test a problem-solving intervention for Spanish-speaking stroke     caregivers that will be delivered over the telephone and online via the previously developed     and nationally available Spanish version of the RESCUE website. The investigators will adapt     their previously pilot-tested problem-solving intervention and make it culturally-relevant     for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief,     telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver     burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and     quality of life, 3) improve Veterans' functional abilities and determine the intervention's     impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine     caregivers' perceptions of the intervention.   "
10931|NCT03142828|"     The work hyposesis is based on the application of a chlorhexidine gel against the     non-application on the healing abutments in patients who have received a submerged titanium     implant to check its effect on healing and prevention of bacterial plaque accumulation during     a period of 1 month.   "
10932|NCT03142815|"     This study will examine whether pre-operative, non-invasive arterial stiffness measurements     can be used to predict which patients will develop an aortic-to-radial pressure gradient     after coronary artery bypass graft (CABG) surgery. A previous small study by Kanazawa, et al.     demonstrated in patients who developed an aortic-to-radial pressure gradient after CABG     surgery, the pulse wave velocity (PWV) was higher in the aorta and decreased when moving     toward the radial artery. In the patients who did not develop a pressure gradient, the PWV     started lower in the aorta and increased when moving towards the periphery.      The purpose of this investigation is to examine whether pre-operative PWV measurements can be     used to identify patients who will develop an aortic to radial pressure gradient after CABG     surgery.      Applanation tonometry will be performed on the right carotid and femoral arteries to assess     carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system,     AtCor Medical, Sydney, Australia). The measurement will be obtained before induction of     general anesthesia in the presurgical area. Also in the presurgical area, a non-invasive     cardiac output (CO) measurement will be obtained by using the ICON Device (Osypka Medical, La     Jolla, California). This CO value will be used to compare to the CO values obtained     invasively in the operating room.   "
10934|NCT03142789|"     In this study we wish to investigate the analgesic effect of the administration of 0.2%     ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a     new suture-method catheter or a standard perineural catheter compared with a single bolus (20     ml), in patients following primary total knee arthroplasty.   "
11881|NCT03130387|"     Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding   "
10936|NCT03142763|"     The objective of this study is to determine the effects of consuming either 3 eggs per day as     compared to a daily choline supplement (choline bitartrate, 397.5 mg choline/day) on plasma     concentrations of High Density Lipoprotein-cholesterol (HDL-C), trimethylamine N-oxide     (TMAO), and other biomarkers of cardiovascular disease risk in young, healthy individuals.     The goal is to determine if choline given as phosphatidylcholine (eggs) will lead to a     different TMAO response when compared to choline in free supplemental form.   "
10937|NCT03142750|"     Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube     dislodgements, are frequent causes of emergency department visits. The investigators have     developed two G-tube dressing designs using commercially available materials and products to     decrease the risk of G-tube related complications. The investigators aim in this study is to     pilot two novel G-tube dressings in patients with pre-existing G-tubes to gain parental     feedback on device designs, ease of use and G-tube stability in preparation for a final     design and trial.   "
10938|NCT03142737|"     The investigators will determine effects of different sources of protein on whole-body net     protein synthesis and muscle protein synthesis in young healthy participants.   "
10939|NCT03142724|"     The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1     receptor targeted radiopharmaceutical.   "
10947|NCT03142620|"     Background:      Helicobacter pylori infection, which affects over 50% of the global population, is one of the     most prevalent infectious diseases in the world. H. pylori infection causes chronic active     gastritis and is associated with peptic ulcer, lymphoma of the mucosa-associated lymphoid     tissue and gastric cancer. The colonization of H. pylori in the hostile gastric environment     is determined by the complex interactions among bacterial, environmental and host factors.     Because of the emergence of antibiotic resistance and adverse drug reactions such as     diarrhea, the successful rates with standard triple therapy for H. pylori eradication are     falling.      Vitamin D or its analogues was found to induce autophagy in keratinocytes, macrophages, and     various cancer cell types. Our preliminary findings indicated that 1α,25-dihydroxyvitamin D3     could induce cathelicidin expression and autophagy in cultured human gastric epithelial     HFE-145 cells and reduced the intracellular survival of H. pylori in a co-culture system. It     was also found that cathelicidin alone reduced the survival of drug-resistant strain of H.     pylori. 1α,25-dihydroxyvitamin D3 also significantly reduced H. pylori colonization in mice,     perhaps through the induction of cathelicidin in the stomach. These findings suggest that     vitamin D not only could control H. pylori but also its drug-resistant strains in humans.      Emerging evidence suggest that vitamin D might be a cost-effective prophylactic and possibly     therapeutic antimicrobial agent for the control and eradication of H. pylori. Since vitamin D     acts through mechanisms independent of standard antibiotics, it is expected that vitamin D     will be equally efficacious for controlling and eradicating drug-resistant strains of H.     pylori. The investigators herein propose that vitamin D in combination of standard     antimicrobial therapeutics could improve the eradication rates of drug-resistant H. pylori.   "
10948|NCT03142607|"     Patient presenting to the dental clinic with gingivitis and fulfilling the inclusion criteria     will be included in the study after taking informed consent. Participants will be divided     into three groups. Each group will be instructed to apply metronidazole gel, chlorhexidine     gel or combination of metronidazole and chlorhexidine gel on the marginal gingiva.     Measurement for the gingival index will be taken at baseline, at 2 weeks and at 4 weeks     interval   "
10949|NCT03142568|"     Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia     and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil.   "
10950|NCT03142555|"     Smoking causes cardiovascular and respiratory diseases, cancers and diabetes, and it has been     a leading risk factor for death globally. Despite the availability of smoking cessation     services locally, most smokers do not use such services. Workplace is one of the most     convenient platforms to provide smoking cessation services and over 55% of smokers are     employed according to the local population-based survey. However, the effectiveness of a     smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and     the attitudes and practices of corporations in promoting smoking cessation are not clear.     Thus, this study aims to examine the employers'/managerial staff's knowledge, attitudes and     practices in promoting smoking cessation in workplace and evaluate the smoking behaviours of     participants before and after attending a smoking cessation intervention.   "
10951|NCT03142542|"     This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with     erectile dysfunction after bilateral nerve-sparing radical prostatectomy.   "
10952|NCT03142529|"     This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of     traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood     dialysis therapy in adults. Half of participants will receive conventional integrated therapy     on chronic renal failure (CRF), while the other half will receive integrated therapy on CRF     and traditional Chinese medicine colonic dialysis.   "
10953|NCT03142516|"     To estimate progression-free survival at one year in elderly patients with RAS/BRAF wild-type     unresectable mCRC and good performance status treated with FOLFIRI + panitumumab as     first-line therapy.      The clinical hypothesis of this study is that the combination of panitumumab and FOLFIRI is a     good treatment option in elderly patients with good performance status and RAS/BRAF wild-type     unresectable mCRC. Another purpose of this clinical trial is to determine the RAS/BRAF     mutation status in liquid biopsies at baseline and at the time of disease progression.   "
10954|NCT03142503|"     Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic     syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and     inflammation are also contributing mechanisms on Ps and PsA. However, little is known about     the influence of diet and micronutrients on the main outcomes of these diseases. The aim of     the investigators is to evaluate the effectiveness of an intervention diet program on disease     activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic     Arthritis.   "
10955|NCT03142490|"     This is an open-label randomized controlled trial of the use of acupuncture in infertile     patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups:     treatment group will receive acupuncture as a complementary approach to IVF and control group     will receive the IVF treatment. Groups will be compared with the World Health Organization     quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI)     and Scope-Stress questionnaires.   "
11013|NCT03141736|"     The purpose of this study is to determine whether the combination of Kangaroo Mother Care     (KMC) as continuously as possible together with the use of a plastic bag in combination with     routine World Health Organization (WHO) thermoregulation care reduces the incidence of     moderate (32-36° C) or severe (<32.0° C) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks     of gestational age (GA) when compared to KMC as continuously as possible together with     routine WHO thermoregulation care.   "
10956|NCT03142477|"     This is a randomized controlled prospective study on the use of therapeutic touch in patients     diagnosed with gynecological cancer. The patients will be randomized into three groups:     control group (will not receive any interventions with therapeutic touch), placebo group     (will receive simulated therapeutic touch intervention by individual not knowing this     technique) and treatment group(will receive therapeutic touch intervention by a trained     therapeutic touch therapist). Two different quality of life questionnaires will be applied     (before and after treatment). Levels of cortisol, salivary IgA, hematological indices and     telomerase activity before and after the use of therapeutic touch will be compared between     groups.   "
10957|NCT03142464|"     Perioperative intravenous fluid (IV) administration has been the standard procedure since     1832 and, is a widely used practice sometimes under inadequate criteria. The present work     aims at verifying the clinical need that justifies the common IV fluid prescription on the     postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL)     elective.   "
10959|NCT03142438|"     This investigation is a prospective, non randomized, non blinded study. This investigation is     designed to evaluate the performance, comfort and ease of use with the F&P trial full face     and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be     recruited from the North Texas Lung and Sleep Clinic (NTLSC) database   "
10960|NCT03142425|"     Collect blood samples and associated clinical data prior to and post radiation treatment.   "
10963|NCT03142386|"     The aim of present study was to study the osteopathic manipulative effects on pain relief and     quality of life improvement on hospitalized oncology geriatric patients. A non-randomized     comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don     Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older     oncology patients were unrolled and allocated in two experimental groups: study group (OMT     group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and     control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23     recruited oncology patients completed the socio-demographic forms and were evaluated, from     external examiner, pain intensity and quality of life. All patients were revaluated at the     end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain     intensity. Standard level of significance was p<0.05.   "
10964|NCT03142373|"     Background. Heart rate variability (HRV) and skin conductance (SC) reflect autonomic activity     and the balance of autonomic nervous system (ANS) which regulates involuntary physiological     functions. The modulation of ANS tonic activity is a target of osteopathic manipulative     treatment (OMT). The main aim of the present study was to verify whether CV4 and RR     osteopathic techniques influence ANS activity, as measured by HRV and SC.      Trial design. A randomized-controlled clinical trial was performed from June 2010 to January     2011.      Methods. 32 healthy adults (33.9±14 years, and 72% female) were selected. At enrollment, all     subjects were randomized in three groups: CV4 group (CV4 technique), Rib Raising group (RR     technique), and Placebo group (PL technique). Each subject of each group underwent respective     technique only once. HRV and SC was continuously recorded during the session respectively     with heart rate monitor Polar S810i and with Onda Scanner Domiana (OSD-Microsale model). All     data analysis was performed using SPSS statistical software and the significance level was     considered at p≤0.05.   "
10965|NCT03142360|"     There is no randomized control study to determine if the beneficial effects of beraprost     sodium could improve the patency of arteriovenous fistula in hemodialysis patients.     Therefore, this study is aimed to demonstrate the use of beraprost sodium can improve the     patency of arteriovenous fistula in patients undergoing hemodialysis. This study is     prospectively randomize controlled open-label trials in patients who newly made artificial     arteriovenous fistula for hemodialysis. This study is a pilot study, and the target number of     subjects is 60 in total, 30 in the treatment group and 30 in the control group.      After randomization, the treatment group takes a beraprost sodium for 6 months and the     control group does not take placebo.      Treatment lasts for 6 months after dosing but continues until the patient changes the     renal-replacement therapy method or falls under the exclusion criteria.      The patient should visit at 1, 3, and 6 months after arteriovenous graft surgery to check the     access site after graft surgery. The doppler ultrasound test is performed to measure the     access blood flow rate and patency of arteriovenous fistula.   "
10966|NCT03142347|"     Comparison effectiveness two methods revascularization of the superficial femoral artery:     remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with     steno-occlusive lesion of the femoro-popliteal segment of TASCII D   "
10968|NCT03142321|"     The overall goal of the study is to develop data that can convincingly guide clinicians on     the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need     to identify response to vedolizumab in small bowel CD using objective endpoints. Current data     suggest that MR enterography may meet this unmet need. There is an additional unmet need to     develop predictive models incorporating both clinical and baseline radiological and     endoscopic variables with higher discriminatory performance in identifying longer term     clinical remission with vedolizumab. Finally, this proposal is strengthened by the     exploratory studies which may identify new proteomic biomarkers that correlate with longer     term radiological response with vedolizumab reflecting its latency of response. If     successful, these serum biomarkers may guide a personalized approach to the treatment of     small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease     activity and the pharmacodynamics of vedolizumab.   "
10969|NCT03142308|"     In Egypt, the evidence for quality processes has not been established yet in the current     training programs for surgery residents. There are no published articles discussing career     satisfaction among surgical residents. Therefore, we are going to conduct a self-designed     survey in Egyptian university hospitals to measure residents' satisfaction and display views     about their undergraduate surgical education, surgical education during internship year,     post-graduate training program, and extracurricular activity during medical school.   "
10970|NCT03142295|"     The primary objective of this pilot study is to investigate the safety and tolerability of     controlled human urine transfusion in female patients with recurrent UTI's.      Seconday and exploratory objectives are to evaluate the diversity of the urine microbiome     after urine transfusion, to assess the longevity of changes in the urine microbiome in     patients after urine transfusion over a period of 6 months and to assess the frequency of     UTI's after the transfusion.   "
10972|NCT03142269|"     A prospective study included 20 patients with super high myopia who underwent bilateral     uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule     polisher randomly in one eye, and the opposite unpolished was used as the control. The     refractive state and size of anterior opening were measured at postoperative 1 day as the     baseline. Then they followed up at 1 month, 3 months and 6 months after surgery to record     refractive state, higher-order aberrations, size of anterior opening, tilt and decentration     of IOL (intraocular lenses)and PAD(postoperative aqueous depth). The paired t test was used     to compare the differences between the two groups, and the same test the postoperative     follow-up comparing with the baseline.   "
10973|NCT03142256|"     This study has two phases. It will be conducted in one site in CT only. Phase I is to     enumerate interest in PrEP uptake among young South African women exposed to a     culturally-appropriate social marketing campaign. This enumeration will also serve as a     recruitment strategy for a cohort with open-label PrEP access in Phase II. The cohort will     assess PrEP acceptability and adherence among 200 HIV-uninfected young women who are offered     open-label daily oral PrEP and randomized to receive or not receive a short term cash     incentive conditional on study drug adherence.   "
10974|NCT03142243|"     Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven     loading, this gradually results in morphological adaptations to the dominant side of the     body. The corresponding morphological asymmetry can be further accentuated by (intensively)     practicing a unilateral sport such as tennis, which is very popular. Yet, research on this     particular topic is scarce, especially in (elite) female players. Furthermore, existing     studies only examine the degree of morphological asymmetry of the upper extremity. Therefore,     the aim of this study is to explore the morphological differences between the dominant and     the non-dominant extremity/side on a whole body level (trunk, upper and lower extremity) in     elite female tennis players.   "
10975|NCT03142230|"     Subject of research : Evaluation of a technique of care to reduce the pain caused by the     laying of the gastric tube in the newborn   "
10976|NCT03142217|"     Huntington's disease is a hereditary disease of rare autosomal dominant transmission, both     neurodegenerative and neuro-psychiatric. Clinically, there are motor symptoms (chorea),     cognitive disorders (dementia) and psychiatric disorders.      Among motor disorders, dysarthria is a commonly found symptom. This is classically referred     to as hyperkinetic dysarthria according to the criteria of Darley's classification. However,     this old classification (1969) is only based on perceptual analysis and lack of specificity.      Moreover, in the course of the disease, chorea (control of the striatal attack D2) decreases     to give place to a parkinsonian syndrome (control of the striatal attack D1) and the     dysarthria also evolves towards a hypokinetic form . It also seems likely that cerebellar     involvement (responsible for ataxia) contributes to dysarthria.      No studies have been published to date to characterize dysarthria in Huntington's disease in     a quantified, objective and specific manner. However, Canan Ozsancak describes choreic     dysarthria as heterogeneous according to the patients and variable according to the     productions. A perceptual study reports an imprecision of the consonants, a lengthening of     the pauses, a variable flow, an absence of modulation of the pitch and a hoarse voice.      Finally, few patients are cared for in speech therapy and there is no specific rehabilitation     strategy: this would require - and justify a more precise study of the dysarthria of these     patients.      The Clinical Evaluation of Dysarthria developed by Pascal Auzou and Véronique     Rolland-Monnoury is a recent and partially standardized tool, combining qualitative and     quantitative evaluation, which seems adapted to try to better characterize the dysarthria in     Huntington's disease.   "
10977|NCT03142204|"     This is a Phase 1 study is to visualize biodistribution of a PET tracer called [18F]F-AraG     (VisAcT) in cancer patients expected to undergo immunotherapy.   "
10978|NCT03142191|"     This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled     study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory     pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with     placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis     (IPF). This study is designed to assess response to treatment by using measures of lung     function, disease progression, fibrosis on radiography, and patient-reported outcomes. It     will also assess dose response.   "
10979|NCT03142178|"     A double-blind, placebo-controlled, crossover, proof of concept study for the use of 3VM1001     Cream, 2g three times daily, for treatment of chronic pain associated with post herpetic     neuralgia (PHN) compared to the inactive vehicle as a placebo.   "
10980|NCT03142165|"     The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy     volunteers.   "
10981|NCT03142152|"     The objective of this prospective, multi-center, randomized, double-blind trial is to assess     the safety and efficacy of the CARILLON Mitral Contour System in treating subjects with     functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized     Control group which is medically managed according to heart failure guidelines.   "
10982|NCT03142139|"     It has been found that the non-live vaccine against Diphtheria, Tetanus, and Pertussis (DTP)     in addition to its disease specific effects may have so called non-specific effects with     the potential to affect sensitivity towards vaccine unrelated pathogens, resulting in excess     mortality(Aaby, Kollmann, & Benn, 2014).      A recent study from Australia found that delayed vaccination with the first dose of     Diphtheria, Tetanus, and acellular Pertussis(DTaP)-containing vaccine is associated with     reduced risk of atopic dermatitis (aOR: 0.57; 95% CI: 0.34-0.97, P = 0.04) and reduced use of     medication against atopic dermatitis (aOR: 0.45; 95% CI: 0.24-0.83, P = 0.01)(Kiraly et al.,     2016).      This register based observational study aims to extend the existing knowledge on non-specific     effects of non-live vaccines by testing the above finding, that delayed vaccination with     Diphtheria, Tetanus, acellular Pertussis - Inactivated Polio vaccine - Haemophilus influenzae     type b (DTaP-IPV-Hib) is associated with lower risk of developing atopic dermatitis before 1     year of age in the Danish birth cohorts from 1997-2012.   "
10983|NCT03142126|"     The researchers are seeking to study whether or not there is benefit in keeping patients flat     after Angioseal for extended periods of time after diagnostic heart catheterization or if a     more aggressive approach of early ambulation would be just as safe while improving cost and     patient comfort.   "
10984|NCT03142113|"     This retrospective multi-centric Belgian observational trial will involve all patients who     have initiated adalimumab for moderate-to-severe ulcerative colitis prior to September 1st     2015 in a Belgian centre maintaining a prospective log of patients using biological therapy.      Only patients fulfilling all Belgian reimbursement criteria for adalimumab will be included,     namely having failed mesalamine and steroids or thiopurine analogues for at least 3 months,     or being intolerant to this therapy, and showing a total Mayo score of at least 6 with an     endoscopic sub-score of at least 2.      Both short-term and long-term outcome of adalimumab therapy will be evaluated, focusing on     the need and successfulness of adalimumab dose-escalation from 40mg every other week to 40mg     every week, and dose de-escalation back to 40mg every other week.   "
10985|NCT03142100|"     Introduction: Bilateral-bimodal users may benefit from bilateral-binaural and a bimodal     effect . The two modes of stimulation complement each other and may overcome the limitation     of electric hearing alone. However, alongside the expected benefits of having two hearing     systems in bilateral bimodal hearing, there are several inherent mismatches in combing two     different stimulation methods, which may negatively impact the processing of the binaural     cues.      Aim: To determine whether bimodal listening with a hearing aid programmed using a dedicated     bimodal fitting formula, which aligns the frequency response, loudness growth functions, and     automatic gain control (AGC) characteristics between the cochlear implant speech processor     and the hearing aid brings additional benefit over bimodal listening with the subject's     clinical hearing instrument via the use of using a comprehensive battery of speech perception     tests aimed at different aspects of binaural hearing as well as the contribution of the     unique bimodal complementary effect. A secondary goal is to identify the tests that are best     suited to predicting and evaluating bimodal benefit.      Method: The study will include 20 Hebrew and 20 Arabic speakers' adult bilateral-bimodal     users that their audiometric thresholds in the non implanted ear will be no worse than 75 dB     HL at 250 and 85 dB HL at 500 Hz, who use their hearing aids for at least 75% of their waking     hours. The added benefit of the hearing aid programmed using a dedicated bimodal fitting     formula will be evaluated using six task-specific tests designed to sensitively assess the     bilateral-binaural and bimodal complementary effects using roving speech and noise and     different types of background noises (maskers), pitch-related task and subjective     questionnaire. Participants will be tested twice in quick succession, at two-weekly     intervals, in establishing a baseline score with their clinical HAs. Then participants will     be tested again twice in quick succession, at two-weekly intervals following three month     experience with the HA fitted with the bimodal fitting formula. All tests will be     administered the CI/HA listening condition.   "
10986|NCT03142087|"     30 patients with brain tumor will be included in the study between the ages of 6 and 18 who     have undergone surgery. Patients included in the study will be randomly assigned to two     groups. The study group will be included in the Nintendo Wii Fit Plus Balance Game exercise     program under the supervision of a physiotherapist for 2 days per week for 8 weeks. The     control group will be taken to the conventional exercise program under the supervision of a     physiotherapist for 2 days a week, 1 hour a day. The assessments will be made before the     exercise program begins and at the end of the 8th week. Patients' physical measurements were     assessed by anthropometric evaluations, muscle strength measurement, pain Visual Analogue     Scale, walking Observational Walking Analysis, Balanced Pediatric Functional Range Test,     Timed Up and Go (TUG) and one foot standing test and Nintendo Wii Fit Plus Balance     Assessment, Functional capacity 2 min. With Walking Test, fatigue with PedsQL     Multidimensional Fatigue Scale, daily life activities will be evaluated with WeeFIM.   "
10987|NCT03142074|"     An aortic aneurysm (thoracic or abdominal) is a permanent dilatation of the aorta caused by     weakening in the arterial wall. The feared complication is aortic rupture or dissection,     leading to potentially lethal aortic bleeding and associated with mortality rates up to 95%.     The current diagnosis criteria do not suffice, therefore the goal of this study is the     development of an improved biomechanics-based and microstructural-based diagnostic tool.   "
10988|NCT03142061|"     Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma   "
10989|NCT03142048|"     Background:      The proportion of elderly people has dramatically increased in recent decades. Moreover,     social and demographic trends show a global increase of elderly people at risk of loneliness     and lack of social relationships. The objective of this study was to evaluate the process,     the effectiveness and the cost-effectiveness of an intervention to reduce social isolation     and its negative effects on health in elderly persons.      Methods:      This is a mixed methods multi-approach evaluation that includes: 1) A qualitative evaluation     among coordinators and participants taking part in the intervention, through in     depth-interviews and focus groups, respectively. The main topics covered will be positive and     negative aspects of the intervention, suggestions for its improvement, opinions on different     aspects of the intervention, and perceived benefits. 2) A quantitative quasi-experimental     design, comparing a group of individuals taking part in the intervention with another group     with similar characteristics not receiving the intervention. Data will be collected at the     beginning and at the end of the intervention. Social support will be measured through     questions drawn from the Medical Outcomes Study and the National Social Life, Health, and     Aging Project questionnaires. Psychological morbidity will be measured through Goldberg's     General Health Questionnaire, and Health-related Quality of Life will be measured through the     EuroQoL questionnaire. Information on visits to the primary care center in the years before     and after the intervention will be obtained from the electronic records of the primary care     centers. 3) A cost-utility analysis, conducted from a health system (primary care)     perspective, including direct costs of the program and the primary care health services used.     The effects of the intervention will be measured on quality-adjusted life years.      Discussion:      There is an urgent need for studies assessing the effectiveness and the efficiency of     potential interventions to reduce social isolation among elderly persons. The results of this     study will help to fill the knowledge gap in this area and might be especially useful for the     development of social and public health policies and programs for older people in     disadvantaged neighborhoods in urban areas.   "
10990|NCT03142035|"     Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the     reproductive age group . It is characterized by the presence of endometrial tissue outside     the uterus, causing pelvic pain and subfertility. It is estimated that around 40% of     infertile women have the diagnosis of endometriosis . Infertility secondary to endometriosis     is thought to be multifactorial. Women with endometriosis often require in vitro     fertilization (IVF). One medical intervention that has been shown to improve IVF outcomes in     women with endometriosis is hormonal suppression with gonadotropic releasing hormone agonist     (GnRH-a) for a period of 3 to 6 months .      In recent years, the effectiveness of dienogest, a fourth-generation progestin, for     endometriosis treatment has been demonstrated. Dienogest seems to be as effective as GnRH-a     in improving endometriosis-related pelvic pain [4]. However, no study has yet assessed     whether dienogest has any benefit in treating endometriosis associated infertility.      The aim of our study is to evaluate the efficacy of dienogest versus GnRH-a in improving     ongoing pregnancy rates in women undergoing IVF due to endometriosis. We will conduct a     non-blinded randomized controlled trial. One group will receive dienogest 2mg daily for a     period of 3 months followed by a standard IVF/Intracytoplasmic Sperm Injection (ICSI) cycle.     The second group will receive one injection of 3.75mg of GnRH-a every 28 days for three doses     followed by a standard IVF/ICSI cycle 3 months later. The third group will not receive any     medical interventions before the planned IVF/ICSI cycle. We hypothesize that patients     receiving dienogest will have similar ongoing pregnancy rates compared to patients receiving     the GnRH-a injection. Secondary outcomes including number of gonadotropins consumed, number     of stimulation days, number of metaphase II eggs retrieved, fertilization rate, embryo     quality, miscarriage rate, clinical pregnancy rates, live birth rates and potential maternal     and obstetrical complications will also be evaluated. We will also compare ongoing pregnancy     rates between the groups receiving Dienogest and placebo, and GnRH agonist and placebo.   "
11014|NCT03141723|"     The purpose of this study is to determine whether the combination of Kangaroo Mother Care     (KMC) as continuously as possible together with the use of a plastic bag in combination with     routine World Health Organization (WHO) thermoregulation care reduces the incidence of     moderate (32-36° C) or severe (<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of     gestational age (GA) when compared to KMC as continuously as possible together with routine     WHO thermoregulation care.   "
10991|NCT03142022|"     Sleep-disordered breathing (SDB) describes a group of disorders in which partial or complete     cessation of breathing occurs many times throughout the night, resulting in daytime     sleepiness or fatigue that interferes with a person's ability to function and reduces quality     of life. Transplantation has become an important treatment modality for end-stage organ     failure. Transplant recipients are now living longer and, hence, develop chronic adverse     medical conditions. Furthermore, transplantation is associated with weight gain. Despite the     high prevalence of poor sleep and cardiovascular conditions among transplant patients, SDB is     not well studied in these patients.   "
11003|NCT03141866|"     This trial will take the form of a feasibility study; designed to assess the feasibility of a     proposed future clinical trial in this setting. This proposed future clinical trial is     proposed to assess the impact of physical activity, in the form of specialised chair based     physical activity interventions, on the physiological, psychological, cognitive, social and     emotional health, and functional capacity of geriatric populations with pre-existing frailty     within a clinical hospital ward setting; recognising health as a holistic concept     incorporating a multitude of inter-related dimensions. This feasibility study is     single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham,     Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).   "
10992|NCT03142009|"     This is a five-year R01 effectiveness trial where tribal partners are committed to assessing     the Family Listening/Circle Program's effectiveness and disseminating the approach and     intervention within Indian Country as a best practice in reducing substance abuse health     disparities.Three specific aims of the grant are 1) To rigorously test effectiveness of FLCP;     with a comparative longitudinal design within and across the tribes, with 4th graders to     prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to     transform their research capacities into local prevention research infrastructures and     partnering; 3)To assess additional program effects on other health/education programs and     leadership within the tribes. In sum, this multi-tribal/academic partnership builds on     accomplishments to test the effectiveness of an innovative intervention. This grant provides     an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen     tribal research capacities, and impact substance abuse prevention research designs     nationally, by illustrating how CBPR processes can integrate evidence-based and     cultural-centered practices to create effective programs that generate community ownership     and sustainability.   "
10993|NCT03141996|"     This study will measure if five minutes of vibration to the upper back neck muscles, prior to     standard of care treatment, will improve symptoms of spatial neglect and/or activities of     daily living function for patients who have had a stroke.   "
10994|NCT03141983|"     Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study     to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for     patients treated with maintenance hemodialysis.   "
10995|NCT03141970|"     This study is a multicentric, randomized, parallel group, open label controlled trial of     children age 1 year up to 4 years with new onset, idiopathic nephrotic syndrome. It is     designed to test the initial duration of steroid therapy of either 3 month or 6 month total     duration. Participants will be randomized to either extend their pre-trial 3 months (12     weeks) of standard of care corticosteroid therapy to add an additional 12 weeks of therapy or     to stop therapy. Pre-trial standard of care corticosteroids will include 60 mg/m2/day for 6     weeks followed by 40 mg/m2/day every other day for 6 weeks of prednisolone or equivalent. The     trial intervention will therefore be an additional 12 vs 0 weeks of corticosteroids in these     children with idiopathic nephrotic syndrome.   "
10996|NCT03141957|"     Aging and cancer are two conditions associated with extensive metabolic changes that can     cause malnutrition. However, the clinical features and the underlying mechanisms leading to     malnutrition are different in these two cases. We therefore wonder how age can influence the     metabolic response to cancer.   "
10997|NCT03141944|"     The objective of this study is to describe the evolution of hypodopaminergic syndrome in     patients with Parkinson's disease.   "
10998|NCT03141931|"     The aim of this study is to compare ocular symptoms and signs when Lacritec nutraceutical     formulation (combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids) is     consumed daily over a 3 month period, with a control capsule that contains polyethylene     glycol (PEG), oleic acid and propylene glycol, which are found in many pharmaceutical     products and are generally considered to be biologically inert and safe. There is good     evidence that the consumption of oily fish has a protective effect against dry eye, and other     studies have provided evidence of the beneficial effect of supplementation with omega-3     essential fatty acids in the treatment of dry eye disease. However, there have been limited     well designed clinical trials investigating the potential for nutraceutical dietary     supplementation to impact ocular comfort. To date, no controlled, randomised clinical trials     have been conducted to evaluate the Lacritec nutraceutical formulation, which is an wholly     Australian owned product. Therefore, the purpose of this study is to conduct a randomized,     placebo-controlled, double-masked study to investigate the effects of dietary supplementation     with a combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids on ocular     comfort including signs and symptoms of dry eye.   "
10999|NCT03141918|"     Among the many changes associated with the impact of HIV and the long-term use of     antiretroviral therapy, metabolics are important because they are important risk factors for     the development of cardiovascular diseases. The objective of the present study is to evaluate     the effect of the supplementation of two bioactive compounds, curcumin and     epigallocatechin-3-gallate, on the oxidation of resting energetic substrates in HIV / AIDS     patients. The sample will be composed of adults living with HIV / AIDS on antiretroviral     therapy for at least 6 months. Supplements will be made separately for 30 days and will be     evaluated before and after the intervention the following parameters: body composition,     energy metabolism, biochemical parameters and a structured anamnesis. Food consumption and     the level of physical activity of the volunteers will be controlled.   "
11284|NCT03138187|"     This study is a randomized controlled trial, designed to evaluate the effect of structured     physical exercise sessions on the spontaneous physical activity energy expenditure and     caloric intake in overweight adults. The design employs a parallel three-group experimental     arms: (1) a moderate exercise group (MEG); (2) a vigorous exercise group (VEG); and a control     group (CG) without physical exercise sessions.   "
11000|NCT03141905|"     The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure     control are well-established in chronic kidney diseases (CKD) patients; however, these agents     may become hazardous on sick-days that lead to volume depletion (dehydration), and increase     the risk of kidney function loss and acute kidney injury (AKI). It is not known how frequent     significant sick-days occur in CKD patients, or whether a patient self-managed Sick-Day     Protocol (SDP) that temporarily holds RAS blocker, diuretics, or other high risk medication     in an effort to preserve renal function, or prevent AKI. The purpose of the study is to asses     if a SDP, monitored remotely with a weekly automated phone survey , can improve outcomes in     CKD (such as slow renal function loss and AKI episodes) and reduce preventable service     utilization versus usual care.   "
11001|NCT03141892|"     This is a pivotal, non-randomized, single arm, multi-center, prospective, non-significant     risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.   "
11002|NCT03141879|"     This trial will take the form of a feasibility study; designed to assess the feasibility of a     proposed future clinical trial in this setting. This proposed future clinical trial is     proposed to assess the impact of physical activity, in the form of specialised chair based     physical activity intervention, on the physiological, psychological, cognitive, social and     emotional health, and functional capacity of geriatric populations with pre-existing frailty     within a residential care setting; recognising health as a holistic concept incorporating a     multitude of inter-related dimensions. This feasibility study is single-centre (taking place     in the Ryland View BUPA care home, Arnhem Way, Tipton, United Kingdom DY4 7HR).   "
11004|NCT03141853|"     A study will be conducted to assess if adults and older adults with arthritis who ride horses     are able to move better, have less pain, enjoy nature more and have a better quality of life     then people who go to class to learn about exercise. This is needed because adults with     arthritis experience joint pain, stiffness, damage to their cartilage, and decreased range of     motion in their hips, knees, shoulders, and back. This study will measure effects on     patient's joints, pain, quality of life, muscle and cartilage before and after either     arthritis exercise education or horse riding. Horses have unique movements that target joints     without weight bearing and possibly show improvements without joint damage.      Twenty two subjects will be assigned to either the equine-assisted therapy (EAT) group or a     group receiving exercise education for 1 hour each week for 6 weeks. Outcomes of pain, joint     mobility and quality of life are measured at 0, 3 and 6 weeks. Enjoyment will be determined     by a survey. Safety procedures include helmets, side walking attendants for balance, and     controlled by a certified riding instructor at a certified riding center. Data will be     gathered and reviewed, to assess the effects of EAT on arthritis.   "
11005|NCT03141840|"     This clinical trial seeks to investigate if an experimental medical device, ABL01, can be     used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested     against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of     the trial is clinical improvement and cure at the 6 and 12 month time-point.   "
11006|NCT03141827|"     This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a     chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood     by controlling the amount of fat made by the liver and gut. Recent research suggests that     insulin may work through the brain. The investigators hypothesize that preferential delivery     of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats     made by the liver and gut.   "
11007|NCT03141814|"     Asthma is characterized by chronic airway inflammation of the large and small airways. Asthma     patients often have episodes with symptoms of dyspnea, wheezing and nocturnal awakening.     Currently available inhaled anti-inflammatory treatments reduce the airway inflammation and     treatment but do not cure the disease. Therefore asthma patients often need life-long     treatment to control their asthma.      In a small subset of patients, their asthma resolves spontaneously. This phenomenon is called     asthma remission. Subjects with asthma remission do not experience symptoms or signs of     airway inflammation anymore and do not require inhaled treatments. Some subjects with asthma     remission also have a completely normal lung function without signs of bronchial     hyperresponsivess: they have complete asthma remission. Unfortunately, asthma remission     occurs only in a small subset of 15-25% of asthma patients.Objective: to determine the     underlying mechanisms and molecular events leading to remission of asthma.   "
11008|NCT03141801|"     Quadriceps muscle weakness is a common consequence following anterior cruciate ligament (ACL)     injury and reconstruction. Maximizing quadriceps strength following ACL injury is significant     as diminished quadriceps strength has been linked to the osteoarthritis that affects over 50%     of surgically reconstructed limbs. Given that knee joint health following ACL injury is     predicated on restoring quadriceps strength, identifying treatment approaches capable of     improving strength is paramount. Blood flow restriction training (BFRT) is a method where     oxygen to the muscle is intentionally reduced during exercise/rehabilitation and may lead to     more timely and substantial strength gains. In the proposed project, we will examine the     efficacy of BFRT in patients who have undergone ACL reconstruction and suffer from     substantial quadriceps weakness.   "
11009|NCT03141788|"     The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth     malocclusions with the use of attachments and/or buttons, as determined by the amount of     teeth movement and overall achievement goals of the treatment plan.   "
11010|NCT03141775|"     IBIS is a prospective, observational study, which aims to assess the cost of CDI per day,     hospitalization and year including description of incremental costs in hospitalized patients,     and recurrent episodes, in German hospitals. Exposure to CDI drugs will not be influenced and     remains at the discretion of the treating physician.      In addition to treatment, Health-related quality of life (HRQL) will be analyzed using     standardized questionnaires.   "
11011|NCT03141762|"     Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study   "
11012|NCT03141749|"     The risk for venous thromboembolism (VTE) in DM1 and in other inherited myopathies, which can     lead to chronic immobilization, are unknown. The purpose of this study is to evaluate     incidence of VTE in cohort of patients presenting with DM1 with a comparison to a group of     other inheritable myopathies and to a community-based population.   "
11015|NCT03141710|"     Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic     (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and     faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day.     Improvement in fasting metabolic parameters was observed flowing the intervention period. A     reduction on Total Cholesterol, Glucose, Triglycerides and Insulin was observed.      In this study, a lower dose (20ml/d) in subjects with type 2 diabetes will be examed, over an     extended period of time (12 week period) to match the profile of the intended consumer and     provide preliminary data to support a larger multi-centre trial.   "
14228|NCT03099226|"     The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of     Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of     Etamicastat (BIA 5-453).   "
11022|NCT03141619|"     This study is designed to test the hypothesis that poor cerebral perfusion during critical     illness is a risk factor for acute and long-term neurological dysfunction among survivors. We     use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive     surrogate marker for cerebral perfusion. Acute neurological dysfunction is defined as the     presence of delirium, which is assessed using the Confusion Assessment Method-Intensive Care     Unit (CAM-ICU). Chronic neurological dysfunction is defined as having quantitative     impairments on robotic testing (KINARM robot) and traditional neuropsychological screening     (Repeatable Battery for the Assessment of Neuropsychological Status).   "
11023|NCT03141606|"     Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset   "
11024|NCT03141593|"     Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with     supplementation by mouth. National guidelines recommend the administration of 800 IU     cholecalciferol daily for an effective treatment, especially during the winter (poor sun     exposition). Commercially available pharmaceutical forms are liquid in Switzerland (drops)     and solid forms in Germany (tablets and capsules). Because therapeutic range of vitamin D3 is     wide and toxicity is seldom reached, even after the consumption of 200'000 IU, and because     the administration of 8 drops daily is inconvenient, weekly and monthly administrations of     the cumulative amount (i.e., 5'600 IU weekly or 24'000 IU monthly) have been investigated.     Both administration schedules are therapeutic equivalent. The study aims to investigate which     form (liquid or solid) and which schedule (weekly or monthly) procure the highest adherence     behavior with outpatients under polypharmacy i.e., with 4 or more medications daily. The     investigators will use commercially available Swiss and German products.   "
11025|NCT03141580|"     The 'Long-term Follow-up Near-infrared Spectroscopy and Intravascular Ultrasound Imaging of     Internal Carotid Artery Stenosis Treated With Stenting' trial is an academic research     project. It follows already published results of a research on carotid plaque composition in     patients undergoing carotid stenting.      Patients who were treated with carotid stenting will be invited to participate on the trial.     The written informed consent will be needed. The participants will undergo carotid     angiography, intravascular near-infrared spectroscopy and intravascular ultrasound of the     extracranial portion of the internal and common carotid artery with implanted stent.      The aim of the trial is to describe long-term change of the luminal and stent dimensions,     vessel wall remodeling and plaque composition after carotid stenting. The findings will help     to understand the long-term effect of carotid stenting on the carotid stenosis and mechanisms     of plaque stabilization - sealing with stent.   "
11026|NCT03141567|"     Heart failure often causes fluid to accumulate in the body, leading to congestion and     swelling. However, some people who have had heart failure for a long time seem to have very     little congestion or swelling, even when the heart failure is poorly treated. The     investigators think that this is because lymphatic vessels are able to grow and remove fluid     to prevent congestion. The investigators do not know how lymphatic vessels grow. This study     will investigate the blood levels of various proteins to try to figure out how the lymph     vessels of people with long-standing heart failure might grow.   "
11027|NCT03141554|"     This study determines the effects of a single dose of different antiseptic mouth washes     within the oral cavity, on the composition of the oral microbiome using next generation     sequencing (NGS) techniques. Twelve healthy volunteers will receive all three test products     in a randomized order to compare the effects of each mouth wash.   "
11028|NCT03141541|"     Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis     in terms of quality of life, disability, sick leave and health care use. Despite existing     literature showing that low back pain patients benefit from cognitive therapy interventions,     this has not been investigated in subgroups of low back pain patients with psychosocial risk     factors.      The purpose of the study is to investigate whether patients referred to secondary care with     low back pain and coexisting psychosocial risk factors will have a better treatment outcome     when participating in a pain management course in addition to usual care.      This will be investigated in a randomised study design, where 130 patients with chronic low     back pain and psychosocial risk factors will be randomly allocated to either usual care or a     cognitive-therapy based pain management intervention in addition to usual care.      The patients will be followed for one year after inclusion, and patientreported outcomes on     disability, pain, sick leave, quality of life and pain coping will be collected by the use of     questionnaires at baseline, 6 months and 12 months.   "
11029|NCT03141528|"     This study investigates whether there is a difference in the BLS skills in first year medical     students directly after training and three months later, when randomly assigned to     self-learning versus instructor-led training courses.   "
11038|NCT03141411|"     Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have     been shown to benefit moderate- to high-risk surgery patients and have recently been     recommended by professional societies in the UK, in France, and in Europe. However, despite     the growing evidence, these strategies are often not implemented in current practice. One of     the reasons for this lack of implementation is that GDFT strategies, like any other complex     clinical protocol, require significant provider attention and vigilance for consistent     implementation and it is well known that even under study conditions protocol compliance     rates are often not greater than 50%. To overpass this problem, our CO monitoring devices     (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software.     This software determines fluid responsiveness by estimating the predicted change in stroke     volume and suggests to the anesthesiologist when fluid is required .   "
11030|NCT03141515|"     Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of     pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts     with anesthesia induction but can persist for hours or even days after surgery.      Lung collapse is a pressure-dependent phenomenon. Each acinus has a critical closing     pressure, i.e., the minimum transpulmonary pressure (Ptp) below that the acinus begins to     collapse. While airway pressure is homogeneously distributed within all lung units, Pleural     pressure increases along the vertical gravitational vector because of the lung's weight. As a     consequence, the decreased Ptp in the dependent zones promotes collapse. This means that     patients in the supine position suffer from increasing closing pressures in the ventral to     dorsal direction.      Alveolar recruitment maneuvers recruit collapsed alveoli, increase gas exchange, and improve     arterial oxygenation.      The investigators hypothesized that in children with anesthesia-induced atelectasis, postural     changes have recruiting effects and improve lung aeration assessed by lung ultrasound.   "
11031|NCT03141502|"     A randomized controlled trial is performed to evaluate the effectiveness and safety of the     Skin Stretching Device (SSD) on limb tension incision closure by comparing whether the     differences in wounds area, wounds closure time and scar assessment between the SSD and the     skin grafting are statistically significant.   "
11077|NCT03140904|"     This study will be conducted as a stratified cluster randomized trial. The unit of     randomization will be the outpatient therapeutic feeding center. The 10 health centers will     be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one     of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support     for home-based surveillance.   "
11032|NCT03141489|"     Malnutrition is highly prevalent among older adults. Adequate treatment is crucial to     maintain health, improve functional status and independency. For severely malnourished     patient, tube feeding is often the most effective treatment, but it also implies a risk of     developing refeeding syndrome (RFS). RFS is described as fluid and electrolyte shifts     particular hypophosphatemia when recommencing nutrition, potentially causing fatal     complications. In 2006 National Institute for Health and Care Excellence (NICE) developed     guidelines regarding 1) detecting patients at risk for RFS and 2) a treatment plan for     refeeding severely malnourished patients. These guidelines have never been validated. Hence,     there is a need to explore the use of different refeeding regimens in the treatment of older     malnourished patients, in regards to assess safety, as well as the impact of the treatment,     on functional status, independency, quality of life and RFS. This will be the first     randomized controlled trial (RCT) that challenges the existing NICE guidelines.This study     will be divided into two parts. Part I: a cross-sectional cohort study, monitoring occurrence     of hypophosphatemia on patients detected as not at risk for RFS according to NICE guidelines.     Part II: a double blinded RCT study, with the aim of tube feeding patients at risk for     developing RFS, and assigned either to an intervention group or to a control group, comparing     the different refeeding regimens. This study will help develop safe and validated refeeding     protocols for severely malnourished older patients.   "
11033|NCT03141476|"     This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was     increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured     in blood and tissue.   "
11034|NCT03141463|"     Immune modulating effects and safety of Vvax001; different dosages will be tested in patients     with a history of (pre) malignant cervical lesions.   "
11035|NCT03141450|"     Surgical site infection (SSI) is a serious operative complication that may be associated with     any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma     concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of     cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of     cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery     with cardiopulmonary bypass including its correlation with the incidence of postoperative     SSI.   "
11036|NCT03141437|"     The goal of this research study is to learn if a decision aid website that provides     information about fertility preservation (maintaining participant's ability to have children     of participant's own after cancer treatment) can help women with cancer make     fertility-preservation decisions. Researchers will also use information learned in this study     to help improve the website. This website was developed at MD Anderson.      There are several ways to preserve fertility, including taking drugs to stop or control ovary     function in order to freeze eggs and/or embryos. Freezing eggs and/or embryos may increase     the chances of having a child of participant's own in the future. Participant may also choose     to have children using other methods, such as adoption. This website is designed to help     women learn more about these options and consider which of them may be best for them.   "
11037|NCT03141424|"     Background: Asthma is a common chronic condition characterized by respiratory symptoms and     hyperresponsive airways. According to treatment guidelines, patients with persistent asthma     require daily treatment with inhaled corticosteroids (ICS). However, certain subgroups of     asthma patients such as non-eosinophilic asthma patients do not respond well to the ICS     treatment. In the present study, asthma patients treated with ICS and exhibiting low levels     of eosinophilic biomarkers such as S-periostin, FeNO and blood eosinophils, are randomized     1:1 to either 1) tapering of ICS or 2) usual care. Thus, the aim of the present study is to     investigate whether patients with non-eosinophilic asthma can sustain their level of disease     control during ICS tapering.      Design: This is a randomized, controlled, one-center, non-inferiority study of ICS tapering     in patients with non-eosinophilic asthma.      Inclusion and exclusion criteria: 1) Objectively secured asthma diagnosis, 2) Age 18-65     years, 3) ICS treatment equivalent to Budesonide 800 microgr daily or more with at least 80%     adherence, 4) Serum-periostin < 50 ng/ml, 5) FeNO<20 ppb at all prior visits, 6)     Blood-eosinophils<0.15 at screening, 7) no allergic asthma history, 8) never daily smoker, 9)     no other respiratory diasease, 10) no daily treatment with immunosuppressives, 11) no     pregnancy, and 12) no history of drug or alcohol abuse.      Endpoints: Primary: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS     and time from baseline to drop-out. Secondary: Change in FeNO, change in Serum-Periostin,     change in FEV1, change in blood-eosinophils.      Methods: Relevant patients will be recruited from Respiratory Outpatient Wards. In total, 110     patients will be required. Visits will be performed at screening, at week 0, 4, 8, 12, 16,     26, 52. In the active arm, ICS dosage will be reduced to 50% at week 0 and removed at week 8.     All visits include ACQ, FeNO, spirometry, blood eosinophils. S-periostin will be measured at     screening and at week 8 and 16.   "
11048|NCT03141281|"     The study will compare the effect of broad and directed (narrow) technology-based training on     basic perceptual and cognitive abilities in older adults and on the performance of simulated     tasks of daily living including driving and fraud avoidance.   "
11882|NCT03130374|"     The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem     cells based therapy for the patients with chronic laryngeal and tracheal stenosis   "
11039|NCT03141398|"     A prospective, observational, comparative study with no intervention.The objective of the     study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose     Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C (Glycated Hemoglobin)     and their relation to iron overload detected by T2* MRI of the pancreas in high-risk patients     due to insulin deficiency (potential beta cell injury) and those with insulin resistance and     to study the different factors that may affect the glycemic control in these patients in     relation to their results like the Dose of corticosteroids and chemotherapy in ALL and     Hemoglobinopathies, Liver function in ALL and Hemoglobinopathies, and Serum ferritin in     Hemoglobinopathies and their transfusion status. Using Validated Tools with Permission, the     participants will be selected through probability (random) sampling method with expected     subjects numbers ALL/L: 30-50, Thalassemia Major: 20, Sickle cell disease: 20.   "
11040|NCT03141385|"     The purpose of this study is to test the hypothesis that remote ischemic preconditioning     prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch     replacement.   "
11078|NCT03140891|"     HFO is recommended as a primary mode in preterm infants.However, It is rarely used as the     noninvasive supporting mode after extubation.   "
11041|NCT03141372|"     Acute urinary retention is a complication of hysterectomies that can result in bladder     over-distension and long term bladder dysfunction. The incidence of acute urinary retention     after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and     34%. Studies have varied in the method of post-operative bladder challenge and the modality     of hysterectomy included. Moreover, most of the published studies are retrospective chart     reviews or prospective observational studies, with a lack of randomized controlled trials.     Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is     performed, use of post-operative narcotics, pre-operative urinary retention, and possibly     aggressive bladder dissection. With the increased trend towards same-day discharge following     TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative     course. Standardization of post-hysterectomy bladder challenge and identification of risk     factors for urinary retention may aid in preventing urinary retention or acute bladder     dysfunction. The primary objective is to compare the rate of void trial failure after TLH     with the backfill technique versus the autofill technique.   "
11042|NCT03141359|"     This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in     subjects with locally-advanced NSCLC (stage II/III) and treated with Stereotactic Body     Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without     consolidation chemotherapy. A total of 56 subjects will be enrolled to this study over a 3     year accrual period.   "
11043|NCT03141346|"     This study will determine whether a home visitation program incorporating sugar sweetened     beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk     for obesity. The postpartum period is a time of both opportunity and vulnerability for     mothers and their infants to diminish risk for obesity and related health problems. This is     particularly relevant in the context of Hispanic families. Hispanic mothers are at high-risk     for excess gestational weight gain and postpartum weight retention, and their infants are at     high-risk for rapid weight gain associated with early onset obesity. A contributing factor     may be their intake of SSB/J. There is a high prevalence of reported SSB/J consumption in     low-income Hispanic households, and Hispanic mothers are more likely to incorporate sweet     foods during weaning. Because evidence suggests that obese Hispanic children are responsive     to SSB/J reduction and substitution with non-caloric beverages, this may be a potential     strategy for Hispanic mothers that may also be beneficial for their infants.      This study will be conducted in collaboration with Antelope Valley Partners for Health, who     will deliver a home visitation program intervention once a week for 24 months.     Two-hundred-and-forty overweight/obese Hispanic mothers and their infants will be recruited.     They will be randomly assigned to: group 1, a standard home visitation program only; group 2,     a standard home visitation program that incorporates sugar reduction; and group 3, a standard     home visitation program that incorporates sugar reduction with home water delivery. The main     outcomes are maternal BMI and infant weight-for-length growth. We will also assess maternal     and infant diet using 24-hour recalls, and maternal feeding style and infant eating behaviors     using questionnaires. Linear mixed effects models will be used to compare changes between the     intervention groups in maternal BMI and infant weight-for-length.   "
11044|NCT03141333|"     The principal study goals are to determine if a randomized control trial would be feasible,     particularly with regards to i) recruitment and retention of parents of children having a     diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the     teleintervention. The study will also examine quantitatively and qualitatively families'     acceptability of- and satisfaction with the teleintervention.   "
11045|NCT03141320|"     This is a grounded theory study aiming to understand women's perception of what influences     their confidence for birth during labour and birth. Data is being collected using interviews     and social media sources.   "
11046|NCT03141307|"     Obtaining adequate informed consent from potential research participants is a significant     challenge for biobank-dependent research. To maintain public trust and support, it is     important to establish an informed decision-making process for the collection and use of     biospecimens collected within clinical settings. For the majority of all infants born in the     US, residual dried blood biospecimens are generated after newborn screening is completed.     Some programs choose to store these specimens for several uses including biomedical research.     Identifying ways to improve comprehension about broad consent for future biobank-dependent     research is a national priority. Specific Aim 1: Identify the key information items necessary     to make an informed decision about broad consent for the retention and future research use of     residual biospecimens. Methods include focus groups with new parents to determine key     information elements relevant to consent for use of residual biospecimens within the Michigan     BioTrust. Additional meetings with IRB personnel within the participating hospitals, health     departments and universities will also be conducted to ascertain their expectations and     requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1,     create a state-of-the-art electronic informed consent information (EICI) tool for use in the     clinical setting about the retention and use of residual biospecimens. The award-winning     Genetic Science Learning Center will develop the professional EICI in Spanish and English.     Validation of the EICI will be completed using feedback from both community and scientific     advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach     by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the     current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in     the state of Michigan, where informed consent is required for biobank research during     postpartum clinical care, will be recruited and randomized to one of three groups. Specific     Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing     hospitals and Department of Community Health staff before and after the intervention.        -  Hypothesis 1) Women in the Interactive technology group (Group A) and the video group          (Group B) will demonstrate higher knowledge at Time 1 and Time 2 about the consent          elements and the BioTrust than those who do not receive either EICI tool (Group C).        -  Hypothesis 2) Women in the EICI groups (Groups A and B) will demonstrate lower          decisional conflict at Time 1 and Time 2 toward biobanking than those who do not receive          the EICI (Group C).        -  Hypothesis 3) Women in the EICI groups (Groups A and B) will not differ significantly in          their choices about biobanking and attitudes toward NBS and biobank research compared to          participants who do not receive EICI tool (Group C).   "
11047|NCT03141294|"     Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational     tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it     needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as     reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare     re-PDT with sd-PDT in ICU patients   "
11883|NCT03130361|"     The objective is to assess the impact of a wearable Noninvasive Positive Pressure     Ventilation, on physical activity and quality of life in patients with severe COPD,     complaining of dyspnea.   "
11049|NCT03141268|"     Orocecal transit time is studied in individuals with irritable bowel syndrome (IBS) of both     the constipation-dominant, diarrhea-dominant, and mixed form using the lactulose hydrogen     breath test for orocecal transit time through the gut. Data are compared to those of healthy     volunteers. The peak value of fermentation as read by hydrogen levels is captured after     passage of the orocecal segment in the colon. Comparison are made between IBS patients and     healthy subjects as regards orocecal transit time and peak fermentation in the cecum.   "
11050|NCT03141255|"     The purpose of the study is to compare patients with cardiogenic shock who receive standard     therapy plus therapeutic hypothermia (TH) to patients with cardiogenic shock who receive     standard medical therapy alone in order to assess the safety of TH in patients with     cardiogenic shock. This study will also help understand the physiologic effects of TH in     patients with cardiogenic shock. This will be a pilot study to establish the initial safety     of TH and to assess tolerability of TH in this patient population.   "
14243|NCT03099031|"     The purpose of this study is to validate the Ottawa score (risk of thromboembolic     recurrences) in cancer patients with thromboembolic disease treated with tinzaparin     (Innohep®)   "
11051|NCT03141242|"     The main goal of the ENACT (ENgaging in Advance Care planning Talks) Group Visit intervention     is to integrate a patient-centered advance care planning process into primary care,     ultimately helping patients to receive medical care that is aligned with their values. The     ENACT Group Visit intervention involves two group discussions about advance care planning     with 8-10 patients who meet for 2-hour sessions, one month apart, facilitated by a     geriatrician and a social worker. This study will compare the ENACT Group Visit intervention     to mailed advance care planning materials.   "
11052|NCT03141229|"     Mindfulness training for teacher and children of primary schools. Blinded and controlled     study design. Burnout as primary outcome for teacher and classroom behavior for children.   "
11053|NCT03141216|"     This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate     postoperative period on the variables resulting from regional and global pulmonary electrical     impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV     mode by mechanical ventilator. Half of the participants will receive VCV followed by PSV for     weaning, while the other half will receive PCV followed by PSV for weaning.   "
11054|NCT03141203|"     This is a multicentre phase I/II trial looking at the combination of romidepsin and     carfilzomib. The aim of the phase I part is to determine the maximum tolerated dose of the     combination. This part will recruit up to 27 patients.      The aim of the phase II part is to assess the activity of the combination at the maximum     tolerated dose in 28 patients.      Patients will receive 8 cycles of romidepsin with carfilzomib and response will be assessed     every second cycle. Patients will be followed up for progression and survival until the end     of the trial.   "
11055|NCT03141190|"     Our understanding of the magnitude of physician burnout, its relationship to diminished     performance and the development of mental and physical illness is crystalizing. Data now     links burnout with diminished physician professionalism, patient outcomes, hospital economics     and patient safety.      Moreover, burnout appears to be a surrogate measure of distress among physicians. In a     national survey of practicing surgeons, alcohol misuse and suicidal ideation were up to 3     times that of the general population. When burnout was present the likelihood increased 25%     and 90%, respectively. Among physicians in general, burnout increases the likelihood of     depressive symptoms 170%. In surgical trainees, there is alarming prevalence of distress     symptoms, with a recent national survey (manuscript in preparation) showing 16% suicidal     ideation, 32% moderate to severe depression, 58% high stress and 61% alcohol misuse or abuse     among PGY-3s. It has been proposed that chronic and overwhelming stress in the absence of     adequate coping skills promotes burnout and associated distress symptoms. It has also been     posited that performance deficits, from surgical errors to poor professionalism, derive in     large part from the deleterious effects of stress on cognition.      Mindfulness mental training, most frequently in the form of Mindfulness-Based Stress     Reduction (MBSR, as developed by John Kabat-Zinn), has been shown to protect or enhance     cognition, well-being and physical health in multiple clinical populations and in healthy     adults. Two decades of research have shown that MBSR and MBSR-based interventions create new     habits in the brain subserved by organic, structural changes. Such interventions have been     shown to protect cognitive function in pre-deployment marines and incarcerated juveniles;     reduce relapse in major depressive disorder; enhance immune function in HIV+ males; reduce     PTSD severity in veterans; enhance job performance in inner-city teachers; improve cognitive     function and pro-social skills in children; increase professionalism and decrease burnout in     PCPs; improve work satisfaction and engagement in numerous populations of health care     workers; and diminish psychological stress in soldiers, physicians and professional athletes.      This study seeks to demonstrate the feasibility of mindfulness training in surgical Interns     while simultaneously providing objective pilot data on the effectiveness of mindfulness     training in a randomized, controlled setting. In-coming surgical Interns will be recruited,     randomized to mindfulness training or an active control group and undergo psychologic,     physiologic, neurocognitive, neuroanatomic and performance assessments at baseline,     post-intervention and one year later. Data will inform sample size calculations for     subsequent, adequately-powered RCTs and will guide the creation of a feasible formal training     model. Moreover, results could significantly impact formal medical training, the mental     health of providers at every level, and the overall quality of patient care.   "
11056|NCT03141177|"     The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib or     Nivolumab and Ipilimumab Combined with Cabozantinib, is safe and effective compared to     Sunitinib in previously untreated advanced or metastatic renal cell carcinoma   "
11057|NCT03141164|"     This study will train participants (young people and older adults) to do a visual task, and     will assess whether this results in changes in behavioral assessments. In some participants,     we will be also testing whether MRI measures (cortical thickness, functional connectivity)     change with training.   "
11058|NCT03141151|"     This study is a family-centered, community-based intervention to prevent and treat childhood     obesity among 3-5 year old children from undeserved communities. Half of participants will     receive a healthy lifestyle intervention and half of participants will receive a     school-readiness intervention.   "
11059|NCT03141138|"     This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates     given in the prime-boost regimen previously demonstrated to have a high level of     immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare     it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to     define the potential tradeoff between potential immunogenicity, including cell-mediated     immunity, and a more practical dosing schedule.   "
11060|NCT03141125|"     Study about the effect of ethanol extract physalis angulate in scleroderma patients with     standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce     inflammation, immunological response and fibrosis: A Randomized Clinical Placebo     ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto     Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to     July 2017   "
11061|NCT03141112|"     The study will evaluate the benefit of early initiation of CRRT in the initial phase of     severe sepsis in patients admitted to the ICU. Primary evaluated end-point is 28-day     mortality. Secondarily evaluated end-point is length of ICU-stay, length of stay in hospital,     duration of mechanical ventilation. There are two groups. One group of participants with     early CRRT initiation and another group with late CRRT initiation. Reference group no CRRT.   "
11062|NCT03141099|"     This study compares two blood pressure targets and two oxygenation targets in the     post-resuscitation care of comatose out-of-hospital cardiac arrets patients. The blood     pressure-intervention is double-blinded and the oxygenation-intervention is open-label. As a     subordinate study, the patients will be randomized 1:1 to active fever-control with automated     feedback temperature control device for 72 hours or to 36 hours following return of     spontaneous circulation   "
11083|NCT03140826|"     Stool samples will be collected from two groups of neutropenic patients in the case that a     therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected     infection. The intestinal resistome will be determined and quantified using shotgun     metagenomics. Based on this, regression models will be used to determine the actual selection     pressure caused by these drugs, and both selective forces will be compared. The results will     reveal if there is a drug that causes a lower selection pressure compared to the other. The     study aims to generate knowledge that is required to design effective antibiotic stewardship     programs.   "
11084|NCT03140813|"     This study will investigate the safety, tolerability and blood pharmacodynamics of treatment     with oral administration of AZD7325 at 5 mg BID, 15 mg BID, and placebo BID, in adults with     Fragile X Syndrome. The study also will also investigate measures of efficacy and biomarkers     during treatment.   "
11063|NCT03141086|"     The main purpose of this study is to demonstrate that LML134 can increase wakefulness     compared to placebo in patients with shift work disorder (SWD) measured by objective and     subjective endpoints of wakefulness, i.e. the sleep latency in the multiple sleep latency     test (MSLT) and the Karolinska Sleepiness Scale (KSS), respectively. Safety and PK of LML134     will also be evaluated. In addition, novel methodologies to measure wakefulness and sleep     will also be tested and compared to gold standard methods like the MSLT and polysomnography     (PSG). The aim of such comparisons is to evaluate the usefulness of the new technologies in     clinical studies and provide preliminary validation data.      This is a randomized, subject and investigator-blinded, placebo controlled, crossover,     multi-center Proof of Concept (PoC) study with in-house simulated laboratory night shifts in     patients with SWD. This non-confirmatory study will include two treatment arms: LML134 and     placebo. After a screening period, the treatment phase of the study will consist of two     overnight stays in a sleep lab in each of two treatment periods, with a minimum one week     wash-out in between.   "
11064|NCT03141073|"     This study evaluates the efficacy and safety and population PK of HMS5552 as add on to     Metformin in type 2 diabetic adult subjects, there will be 2 groups, in the first 24 weeks,     one group will receive HMS5552 plus Metformin, while the other group will receive placebo     plus Metformin; after 24 weeks, all subjects received HMS5552 plus Metformin for 28 weeks.   "
11065|NCT03141060|"     This study will evaluate the pharmacokinetics, safety, and tolerability of the     anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug     background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in HIV-infected and     HIV-uninfected children with MDR-TB.   "
11066|NCT03141047|"     A new psychological trauma treatment method is tested on a population (n 100) of adult women     who have been sexually traumatized at one specific time 0-5 years before they enter the     study.   "
14279|NCT03098550|"     The purpose of this study is to determine whether a combination of nivolumab and daratumumab     is safe and effective when treating advanced tumors or tumors that have spread   "
11067|NCT03141034|"     The investigators hypothesize that this combination regimen of irinotecan plus ramucirumab     administered as second line treatment will be tolerated and lead to improved outcomes similar     to paclitaxel plus ramucirumab in patients with advanced gastric and gastro-esophageal     junction (GEJ) cancers. This study proposes a phase II clinical trial with irinotecan plus     ramucirumab for treatment of patients with metastatic gastric and GEJ adenocarcinoma who have     progressed after first line chemotherapy. To the knowledge of the investigators, this regimen     has not been previously administered to this patient population, so safety and tolerability     will be monitored and reported.   "
11068|NCT03141021|"     First, the investigators plan to use a retrospective analysis to determine the clinical     landscape of neurofibromatosis (NF)1-associated malignant peripheral nerve sheath tumor     (MPNST) and precursor lesions (e.g., atypical or nodular plexiform neurofibromas). A     worldwide database will be established, collecting, in a standardized manner, histologic,     immunohistochemical, molecular, radiographic, treatment, and related clinical data from     centers worldwide with expertise in these NF1-related cancers. Although retrospective in     nature, the resulting data from this registry may reveal previously unanticipated patterns,     similar to the INFACT effort outcome. This registry would then allow the acquisition of data     associated with MPNST biospecimens collected under associated banks (frozen or     paraffin-embedded, germline (or normal tissue DNA) samples, and any previously somatic     whole-exome or whole-genome sequencing data for aggregate analyses). Second, the     investigators plan to co-register patients to institutional banks in order to prospectively     collect MPNST samples for analysis. These patients will be consented in order to collect the     above information and for banking of tumor tissue and future studies that include genomic     characterization of the tumors.   "
11069|NCT03141008|"     To evaluate the impact of a Low Carbohydrate Ketogenic Diet (LCKD) weight loss program and     compare to the standard of care program established for patients with Non-Alcoholic Fatty     Liver Disease (NAFLD) on: (1) Liver fat and liver stiffness scores, (2) lipid profile and     insulin sensitivity; and (3) depression scores and quality of life, and (4) Cardiometabolic     measures such as cardiopulmonary exercise test (CPET) and transthoracic echocardiogram (TTE).   "
11070|NCT03140995|"     Regular physical activity is important for people with rheumatoid arthritis (RA). Sleep     requirements for adults should be on a 'sleep needs spectrum' of between 7 to 9 hours per     day. Poor sleep is a common complaint among people with RA, which may have an effect on their     activity levels and well-being. There is evidence that physical activity and exercise can     improve sleep quality and disturbances in other chronic disease populations therefore,     examining how same affects sleep in RA is important.   "
11071|NCT03140982|"     Using very slow or fast propofol intravenous injection, monitored using standard American     Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate     by a neurologist every 30 sec using the FOUR coma scale.   "
11072|NCT03140969|"     The purpose of this study is to evaluate the safety and tolerability of QR-110 administered     via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation.   "
11073|NCT03140956|"     The purpose of the study is to investigate PK of levodopa in plasma after repeated doses of 3     levodopa formulations given in combination with carbidopa and ODM-104 and compared to the PK     of standard IR and CR levodopa formulations in the same combination.   "
11085|NCT03140800|"     Intrauterine contraceptive device is one of the most efficient and reversible methods of     birth control with low cost and long duration of use However, in the first year after     insertion, between 5 and 15% of women will have their Intrauterine contraceptive device     removed because of irregular uterine bleeding which have been attributed to the effect of     contact between the device and the endometrium and even the pressure on the uterine muscle .     The disharmonious relationship between the Intrauterine contraceptive device and the uterus     is the cause of most of the bleeding complaints, so bleeding is related to improper position     rather than the contraceptive method itself which should be excluded before abandoning the     Intrauterine contraceptive device for any other method of birth control   "
11285|NCT03138174|"     Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose     monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements,     glucose samples must be distributed over the operating range of the blood glucose monitor as     stipulated in ISO:15197   "
11074|NCT03140943|"     All patients with multiple myeloma (MM) are destined to relapse even with the best available     approved agents. Median OS from diagnosis in the current era is reported at 5.4 years. Given     that myeloma remains an incurable disease, future improved OS is therefore reliant on the     expansion of salvage options for patients with RRMM.      Carfilzomib (formerly PR-171) is a tetrapeptide epoxyketone-based irreversible inhibitor of     the 20S proteasome. This second-generation proteasome inhibitor (PI) is structurally and     mechanistically different to the dipeptide boronic acid PI, bortezomib. Compared to     bortezomib, carfilzomib showed less off-target activity that may account for the reduced     myelosuppression and reduced neuropathy that is observed compared to bortezomib. As     monotherapy, carfilzomib has demonstrated robust and durable activity in heavily pre-treated     patients with RRMM in phase I and II trials The idea of combining a PI and an     immunomodulatory drug (IMiD) such as thalidomide or lenalidomide is attractive in MM due to     the efficacy previously demonstrated with combination bortezomib, thalidomide and     dexamethasone. Such efficacy obviates the need for chemotherapy that is known to induce     genetic instability and in turn gives rise to secondary cancers. In combination with     lenalidomide (25mg), Niesvizky and colleagues have demonstrated a maximum planned dose (MPD)     of carfilzomib as 20/27 mg/m2 with promising safety and efficacy. Combination carfilzomib and     thalidomide, as opposed to lenalidomide, is practically a more affordable regimen that will     be more applicable to the Asia-Pacific region.   "
11075|NCT03140930|"     Rationale: The appearance of tastants in the small intestine can result in the activation of     a negative feedback mechanism from different parts of the intestine to the stomach, the small     intestine and to the central nervous system. These processes inhibit food processing,     appetite sensations and food intake, and furthermore they increase feelings of satiety and     satiation. The effects of intraduodenal and/or intraileal infusion of a combination of     tastants (sweet (rebaudioside A), bitter (quinine) en umami (monosodium glutamate(MSG))) and     placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be     investigated.      Objective: To investigate the effect of intraduodenal, intraileal and combined infusion of a     combination of tastants versus infusion of placebo on food intake.      Secondary objectives:        1. To compare the effect of intraduodenal versus intraileal versus combined intraduodenal          and intraileal delivery of a combination of tastants on satiation.        2. To assess the effect of intraduodenal and/or intraileal delivery of a combination of          tastants on gastrointestinal symptoms/complaints.   "
11076|NCT03140917|"     In liver surgery peroperative assessment och the future liver remnant (FLR) is pivotal in     order to avoid posthepatectomy liver failure. To date this is mainly performed by measuring     the volume of the FLR. Of course FLR volume acts as a surrogate measure of FLR function and     the correlation between volume and function is not always accurate. Several techniques to     assess FLR function has been proposed. Hepatobiliary scintigraphy (HBS) and Dynamic MRI are     the two such methods. In this study we compare HBS and MRI, in addition to contrast-enhanced     CT and ICG, repeatedly performed before and after right hepatectomy in patients with     colorectal liver metastases treated with neoadjuvant chemotherapy.   "
11080|NCT03140865|"     Efforts to find treatments for AD have yielded only modest benefits, likely because     longstanding AD pathological processes induce irreversible neurological compromise. These     processes begin years before the onset of clinical symptoms. This possibility has been     incorporated into a model describing stages of AD development, articulated by the     NIA/Alzheimer's Association preclinical workgroup of which the Co-Director of the Kulynych     Alzheimer's Research Center, Dr. Suzanne Craft, was a member. According to this model, the     best hope for countermanding the effects of AD lies in intervening at the earliest possible     point in the pathological cascade. There are several important ongoing efforts in adults with     preclinical AD that directly target amyloid aggregation. Although this strategy addresses an     important aspect of the AD pathological cascade, we believe that addressing metabolic     dysfunction affecting glucose and insulin regulation offers a complementary approach, in that     it may reduce amyloid burden and toxicity, while also directly enhancing synaptic health,     brain metabolism, tau regulation and neurovascular function.      The purpose of the ADCC is to identify and characterize early risk factors that predict     cognitive decline and dementia in asymptomatic adults and adults with early signs of     cognitive impairment. The data obtained from this study, collected at enrollment and     follow-up will allow us to examine disease trajectory in individuals with and without     prediabetes and other measures of glucoregulatory dysfunction in this process. The enrollees,     who will be well-characterized with regard to cognitive and metabolic status through ADCC     assessments, will provide an important resource for other local (institution) and national     investigations. Data collected from participants enrolled in the ADCC will be stored     indefinitely for future investigations.   "
11081|NCT03140852|"     The goal of this study is to obtain data about the effectiveness, reach, adoption, and     implementation potential of an innovative, combined urinary/bowel continence workshop through     a randomized controlled trial in six Wisconsin communities. This three-session workshop is     based on proven principles of behavior change addressing urinary and bowel continence     self-management and health education and has been developed specifically for administration     to women age 50 and older in senior centers. We hypothesize that workshop participants will     experience improvements in urinary and bowel incontinence symptoms, will have increased     levels of care-seeking and self-efficacy for these conditions, and will maintain the     self-management strategies taught in the workshop 3 months following completion of the     workshop. We further hypothesize that this workshop will reach its intended target population     (independent senior women with incontinence) and will improve their mental health by     destigmatizing the condition of incontinence.   "
11082|NCT03140839|"     The proposed research will study the effects of Imaginal Rescripting (IR) for social anxiety     disorder (SAD). IR guides patients to change their memories of past socially painful events.     Initial studies have found that a single session of IR significantly reduces SAD symptoms,     however it is not yet clear how or why IR works and whether its effects are long lasting. To     answer these questions, the investigators will randomly assign adults with SAD to receive     either IR, or two other types of brief psychological interventions: Imaginal Exposure and     Supportive Counselling. Changes in participants' memories, social anxiety symptoms, quality     of life, negative beliefs, and social behaviour over the course of a 6-month period will be     assessed. This study will provide valuable insight into the short- and long-term effects of     IR and clarify the mechanisms through which IR works. Ultimately, this knowledge will enable     the development of more effective treatments and prevention programs for SAD.   "
11105|NCT03140540|"     Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to     achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index     (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen     delivery.      Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas     analysis intraoperatively, after 12 hours and 48 hrs postoperatively   "
11086|NCT03140787|"     68 healthy children from the Department of Pediatric Dentistry at Damascus University who     require treatment for their primary maxillary second molars will be randomly assigned into     one of two groups: experimental or control groups. In the experimental group, a lidocaine     hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper     second molar before the commencement of treatment.      To assess the efficacy of this kind of anesthesia, a specific scale will be used by an     external observer after capturing some video files of the performed treatment.      To assess the safety of this procedure, vital signs will be recorded before and after     treatment.      Acceptance of the nasal spray will be recorded based on the child's behavior before and after     treatment using Frankl scale.      If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be     used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2%     with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral     lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and     acceptance will be assessed in the same manner to what is performed in the experimental     group.   "
11087|NCT03140774|"     The Oxford University is undertaking a follow-on study to a Phase 1 study involving the two     viral vectored Ebola vaccines Ad26-ZEBOV and MVA-BN-Filo. The aim of this study is to     investigate the persistence of the vaccine induced immune response, 24 months after     administration of the primary vaccination.   "
11088|NCT03140761|"     To investigate the correlation between four well-known polymorphisms of the glucocorticoid     receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the     occurrence of secondary adrenal insufficiency in glucocorticoid-treated hospitalised patients     with exacerbation of COPD.   "
11089|NCT03140748|"     Intraabdominal fungal infections with Candida are constantly increasing. Their diagnosis and     treatment is difficult. Morbidity and mortality are high. Β-D-Glucan has been proposed as a     marker of systemic fungal infection in candidemia. Moreover, its kinetics is associated with     therapeutic success. On the other hand, there are no data on intraabdominal infections that     are much more frequent. The objective of the study is to evaluate the initial levels of     β-D-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation     compared to a control group with a yeast-free peritonitis.   "
11090|NCT03140735|"     Aortic valve pathology is the third most common cardiovascular disease after coronary artery     disease and hypertension, which is responsible for severe morbidity and mortality in elderly     patients and requires surgical treatment in its most severe form of progression. The purpose     of this study is to find a link between arterial stiffness and degenerative aortic stenosis.     If this link is established, arterial stiffness may become a medical therapeutic target in     order to delay the evolution of the disease.   "
11091|NCT03140722|"     This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa     for the treatment of anemia in subjects with DD-CKD who are hyporesponsive to ESAs.   "
11092|NCT03140709|"     This study will aid in the development of a research instrument for rapid and highly     sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two     study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total of     25 participants.The standard clinical protocols for administering oxytocin to human subjects     at Lucile Packard Children's Hospital will be followed. Oxytocin will be prescribed and dosed     as per standard of care with no change due to study enrollment. The study will only involve     sampling of saliva and blood.      The general hypothesis to be tested is that 1) the sensor will accurately report the levels     of oxytocin in saliva samples as compared with standard reference methods and 2) the sensor     yields rapid (<20 minutes) oxytocin results with minimal discomfort to subjects. Overall,     this will allow to optimize the administration of oxytocin, and for a better understanding of     the blood concentration and effects of oxytocin on mother and child.   "
11093|NCT03140696|"     This formative research seeks to explore the use of egg (as a potential source of protein) as     nutritional supplement for young children aged 6-8 months of either sex and breast milk     composition of mothers of infants under 6 months old living in an urban slum of Dhaka city,     Bangladesh.   "
11094|NCT03140683|"     In recent decades, the percentage of Cesarean section deliveries has dramatically increased     in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased     steadily.      The pregnant women with previous Cesarean section face a difficult choice for their next     delivery between a trial of labor after Cesarean or repeat caesarean section delivery.      The performance of multiple Cesarean section exposes women to greater risks of complications;     furthermore, the risk of complications increases with each subsequent Cesarean section.      In fact, women with previous Cesarean section are more likely to experience short and     long-term maternal complications in future pregnancies, or a trial of labor after Cesarean,     with the risk of [uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage     and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and     difficulties during surgery   "
11095|NCT03140670|"     The main purpose of this study is to look at the effectiveness, safety, and antitumor     activity (preventing growth of the tumor) of the experimental study drug rucaparib (also     known as CO-338) on subjects and on their pancreatic cancer.   "
11106|NCT03140527|"     This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy     volunteers (HV) into four treatment groups. The first group will enroll HV into a single     ascending dose (SAD) treatment group consisting of three cohorts. The second group will     enroll HV into a multiple ascending dose (MAD) treatment group consisting of three cohorts.     The third group will enroll HV into a food effect (FE) treatment group consisting of one     cohort. The fourth group will enroll HV into a drug-drug interactions (DDI) treatment group     consisting of one cohort. Part 2 will enroll adult subjects with cystic fibrosis (CF)     currently on stable ivacaftor/lumacaftor background therapy for a minimum of three months     into a MAD treatment group consisting of three cohorts. Approximately 120 subjects will be     enrolled.   "
11107|NCT03140514|"     In this study investigators will investigate whether early treatment of allograft rejection,     as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.   "
11299|NCT03137992|"     The purpose of this study is to show bioequivalence of test product to reference product     based on baseline-adjusted forced expiratory volume in one second (FEV1).   "
11096|NCT03140657|"     Ankylosing spondylitis is a chronic autoimmune disease in which T cells associated with the     disorder. The disease often affects the spine and hip bones. Inflammation involved in the     area of the sacrum - Sacroiliac hip joints, pelvis, spinal lumbar, thoracic and cervical.     Curcumin is a polyphenol. It is an active component of turmeric which is a perennial plant.     Curcumin binding with a range of protein and the have ability to inhibit the activity of     various kinases. Curcumin has a combination of activities such as antioxidant,     anti-proliferation, anti-invasive, and can used in the treatment of Alzheimer's, Parkinson's,     Multiple sclerosis, Cardiovascular disease, Bacterial diseases and Arthritis and ankylosing     spondylitis. This increases the solubility of curcumin in nanomicelles spherical water to     more than 100 thousand times, which significantly enhances the absorption of curcumin. A     group of circulating miRNA in plasma is found to be the change they can be involved in     inflammation or inhibit it. MiRNA expression profiles in blood and serum samples taken from     patients with ankylosing spondylitis review that is miRNA-326 also affects cells of the     immune system may be involved in disease ankylosing spondylitis. MiRNA-326 induces     differentiation of Th17 cells via specific transcription factors, such as the RoRγt. MiRNA326     increased the expression of transcription factor RoRγt and Th17 cell differentiation TCD4 +     cells resulting in the production of inflammatory cytokine IL17 increased inflammation and     progression of inflammatory disease ankylosing spondylitis (AS).   "
11097|NCT03140644|"     The goal of this study is to evaluate the diagnostic agreement between, on the one hand,     ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan,     to quantify lung parenchyma patterns in thoracic sarcoidosis.   "
11098|NCT03140631|"     The objective of this study is to evaluate the safety, efficacy and efficiency of rapid     anticoagulation reversal with protamine sulfate versus routine ACT monitoring in patients     undergoing catheter based ablation of atrial fibrillation.   "
11116|NCT03140397|"     The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary     plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have     known potential biological properties, but poor bioavailability due to their low oral     absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo     controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout     periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake.     Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids     on the function of cells of the immune system.   "
11180|NCT03139565|"     The study will test whether a high dose influenza vaccination results in improved     immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single     center prospective observer-blind randomized controlled trial conducted at the Toronto     General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario,     Canada.   "
11099|NCT03140618|"     The care environment influences both patients' experiences of care as well as staff's     experiences of the work environment. A radical change in physical environment is planned at a     psychiatric ward, aiming at creating a care environment that supports patients' opportunities     for recovery from mental ill-health and to create a better and more attractive work     environment for the staff. The rebuilding involves a new ward layout and new innovations such     as light installations, a comfort room and an activity room.      The study uses a single-system design to evaluate the effects of the intervention - the     rebuilt ward. Both quantitative and qualitative data will be used in the evaluation. Data     will be collected using questionnaires measuring dimensions of patients' well-being and     experiences of the care environment, staff's experiences of work-related stress and work     environment, quality of care, a device measuring physical activity, existing clinical     registers and data from medical files, staff' sick leave, participant observations, and     semi-structured interviews.      This evaluation study, to our knowledge the first of it's kind in Sweden, is expected to     generate important knowledge of the effect of the change process that can be used at other     psychiatric wards to design the inpatient care environment. In the long run, the study could     lead to a better reputation of psychiatric nursing and to more attractive workplaces.   "
11100|NCT03140605|"     Familial hypercholesterolemia (FH) [heterozygous (heFH) or homozygous FH (hoFH)] is a common     genetic disorder, characterized by elevated plasma low density lipoprotein (LDL) cholesterol     concentration leading (if untreated) to cholesterol deposits in the corneas, eyelids and     extensor tendons, rapidly progressing vascular disease, and aortic valve disease.   "
11101|NCT03140592|"     Pancreatic cancer is a very aggressive cancer. Over the past 40 years there has not been much     progress made in reducing deaths from this cancer. Recently, new models of pancreatic cancers     have been generated from mouse and human tissues. These models have used larger pieces of     tissues taken from surgical removal of pancreatic cancers.      The purpose of this study is to determine whether these new pancreatic cancer models can be     generated from the small biopsies we take to make the diagnosis of the pancreatic mass.   "
11102|NCT03140579|"     This study evaluates the effect of airway pressure release ventilation (APRV) on lung     homogeneity and recruitment in patients with moderate to severe acute respiratory distress     syndrome (ARDS).      It will do this by comparing the homogeneity of ventilation and recruitment prior to a     patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.   "
11103|NCT03140566|"     CAVA-ADHF is designed as a prospective, randomized, controlled, patient-blinded, multicenter,     parallel-group trial. The objective is to test whether evaluation of the inferior vena cava     diameter in addition to clinical assessment is superior compared to clinical assessment alone     with respect to the surrogate endpoint of change in NT-proBNP from baseline to discharge. The     CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).   "
11104|NCT03140553|"     Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by     TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant     Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is     unknown which regimen is better. This study is to evaluate the efficacy and safety of TCH     (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide     followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment in HER2-Positive     breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for     survival. Safety and tolerability assessed by number of grade 4 toxicities and     hospitalizations.   "
11108|NCT03140501|"     The goal of our study is to evaluate the use of a self-management application (app) that     the investigators have developed to help facilitate self-management among individuals with     SCI who live in the community. The main purpose is to create and fulfill individual     self-management goals. Other purposes include improving self-management and health conditions     related to SCI.      During the initial phase, participants (SCI clinicians and patients with SCI) reported     positive usage of the self-management app and all agreed it would benefit people with SCI.     With the widespread use of portable electronic devices, an opportunity exists to help     patients and informal caregivers on the journey from rehabilitation to integration back into     the community. The investigators will use a randomized controlled trial (randomly putting     participants into two groups), including both surveys and interviews. The study will involve     the use of the app that focuses on the self-management of SCI, along with five to six     in-person or telephone meetings over a three-month period.      Our proposal is original in that it will be one of the few randomized control trials for     e-health interventions for self-care management for those with SCI. The overall goals of the     study is to develop an affordable self-management app that can be used to encourage     self-management in people living with SCI. This app would be used along with other health     problem specific apps that are more detailed and expensive, while helping participants to     manage their long-term health problems related to their SCI in an easily usable and     affordable form.   "
11109|NCT03140488|"     Obesity is considered one of the biggest public health concern of the 21st century and     increases the risk of many comorbid medical conditions. Obesity in pregnancy places women at     higher risk of obstetrical complications during pregnancy, delivery and postpartum. In     particular, obese pregnant women have more difficulty going into labor, a longer labor     course, and even with pharmacologic treatment, have a higher chance of requiring cesarean     delivery.      When pregnant women need help going into labor, they commonly receive a medication called     Pitocin on the labor and delivery floor. Pitocin is the brand name and is a synthetic analog     to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into     labor. This medication has been used widely around the world. There is emerging evidence that     obese women need more oxytocin to go into labor compared to their lean cohorts. There are     many studies to support the use of different oxytocin dosages and are currently supported by     the American College of Obstetricians and Gynecologists. Despite these evidences, a low dose     oxytocin regimen is universally used in the United States, regardless of patient     characteristics.      This study is a double blinded randomized controlled trial. Both lean and obese cohorts will     be recruited for the study. The investigators will randomly place both cohorts into the low     or the high dose oxytocin regimen treatment group. The investigators, patients and providers     will be blinded and will not know the specific assignments. The purpose of this study is to     evaluate the effect of high dose oxytocin in the obese cohort. The hypothesis is that obese     patient will have shorter time to delivery with the high dose oxytocin regimen without     incurring any additional risks or adverse outcomes.   "
11110|NCT03140475|"     Metacognition is the ability to introspect and report one's own mental states, or in other     words to know how much one knows. It allows us to form a sense of confidence about decisions     one makes in daily life, so one can commit to one option if our confidence is high, or seek     for more evidence before commitment if our confidence is low. Although this function is     crucial to behave adequately in a complex environment, confidence judgments are not always     optimal. Notably, individuals with schizophrenia are prone to overconfidence in errors and     underconfidence in correct answers. In schizophrenia, confidence is less correlated with     performance compared to controls.      These aspects are held to be at the origin of delusions, disorganization, poor insight into     illness and into cognitive deficit and poor social functioning.      Our study aims at identifying the cognitive and neural processes involved in metacognitive     deficits in schizophrenia. Participants will perform metacognitive judgments on a low-level     perceptual task (visual motion discrimination). Participants will do the first-order     perceptual task by clicking on the correct answer with a mouse. During the first order task     completion, the investigators will record several behavioral, physiological and neural     variables. Then, participants will perform the metacognitive task with a visual analog scale.      The study will address four research questions:        -  Q1: is schizophrenia associated with a decrease in metacognitive efficiency? Is the          metacognitive deficit due to under- or over-confidence?        -  Q2: is the metacognitive impairment reflected at a decisional level as measured by          behavioral variables (mouse tracking and reaction times)?        -  Q3: which physiological markers (EEG, skin conductance, heart rate) are predictors of          metacognitive efficiency in individuals with schizophrenia and healthy controls?        -  Q4: which clinical symptoms correlate with metacognitive deficits?      The investigators make several hypotheses related to the previous research questions:        -  Q1: the investigators expect metacognitive deficits in schizophrenia, based on results          from several studies using both qualitative and quantitative measures. The investigators          will rule out that quantitative deficits are not confounded with impairments in type 1          performance, with a generalized cognitive deficit in schizophrenia (lower premorbid and          current Intelligence Quotient (IQ), and deficits in executive functioning and          particularly in planning and working memory abilities), with depression or with          statistical flaws during analysis of confidence.        -  Q2: the investigators expect behavioral cues (mouse tracking and reaction times) to be          less correlated with confidence in patients vs. controls. The investigators thus make          the hypothesis that the metacognitive deficit in schizophrenia may stem from an          inability to integrate pre-decisional cues while performing an explicit metacognitive          judgment.        -  Q3: the investigators expect physiological cues (EEG with Error-Related Negativity,          Lateralized Readiness Potential and alpha suppression, and arousal of the autonomic          nervous system with skin conductance and heart rate ) to be less correlated with          confidence in patients vs. controls.        -  Q4: based on previous findings, the investigators expect that several clinical          dimensions of schizophrenia may correlate with metacognitive performance. The          metacognitive deficit would be greater for patients with high levels of positive and          disorganized symptoms, and greater for patients with low levels of clinical and          cognitive insight, and low levels of social functioning.   "
11111|NCT03140462|"     To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus     blood concentration in liver transplant recipients.   "
11112|NCT03140449|"     The aim of the study is to determine the effect and safety of topical rapamycin or calcitriol     and their combination for the treatment of TSC-associated facial angiofibroma.      Methods: A total of 52 TSC patients including 20 male and 32 female subjects were recruited,     and 50 of them completed the period 1 study. In period 1, topical rapamycin (0.1%) or     calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day     by a left-right randomized, split-face comparison for 12 weeks. The primary end point was the     reduction of facial angiofibroma severity index (FASI) for the grade of erythema, papule     size, elevation and extension of the lesions at week 12. In period 2, the patients entered an     open-label study and were reassigned to use the more effective ointment on both cheeks for     another 12 weeks (week 13-24). A follow-up FASI analysis for recurrence after drug     discontinuance for 12 weeks was also performed (week 36). The secondary end point was the     reduction of Visual Analysis Score (VAS) evaluated by the subjects themselves at week 12.   "
11113|NCT03140436|"     This study was designed to find out the stain removal efficacy and also, to find out the     operators and patients opinion when use or receive treatment with both air polishing powders.   "
11114|NCT03140423|"     The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the     non-inferiority of two decolonization regimens:      Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the     context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with     iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that     enrolled subjects represents 137 individual HCA Hospitals (representing ~235 ICUs) that     have been randomized.   "
11115|NCT03140410|"     Understanding the emergence of linezolid-resistance in Staphylococci has been allowed in the     past years through the discovery of the clonal dissemination of a chromosomal cassette     carrying a modified crf gene. New mutations have even been described. Though, clinical     evidences are still lacking, especially concerning the factors associated to this emergence.     It could seriously become quite problematic to eliminate one of the last therapeutic weapon     at our disposal for the treatment of severe or complicated infections caused by resistant     strains of Staphylococci and Enterococci.      We aim to describe the mechanisms that permitted to this resistance to become clinically     significant, concerning meticillin-resistant Staphyloccocus epidermidis strains causing blood     stream infections in ICU patients, and show the clinical risk factors associated with it     through a case-control study on patients hospitalized in two ICUs of our hospital between     2011 and 2016.   "
11140|NCT03140085|"     Urinary tract infections are among the most prevalent microbial diseases and their financial     burden on society is substantial. The use of bacteriophages against bacterial pathogens has     gained over the last years a renewed interest, because of the continuing increase in     antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy     of intravesical bacteriophage treatment to normalize urine culture compared to intravesical     placebo or standard antibiotic treatment.   "
11117|NCT03140384|"     In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is     preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol.     This is recommended orally at a dose of 400 μg. There are currently several studies on the     subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of     administration and gestational age differ in all studies. Currently, HAS recommends the     vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to     compare the different routes of administration of Misoprostol at the same dose to allow to     change our French recommendations on the medicinal abortion and perhaps also to recommend the     vaginal route in this indication.   "
11118|NCT03140371|"     Oral nutritional supplements and enteral tube feeds are commonly used to meet the nutritional     requirements of patients with disease-related malnutrition, or who require medical nutrition     support for other reasons. Some patients may not tolerate standard formulations containing     whole proteins (typically due to maldigestion/malabsorption) leading to gastrointestinal     symptoms (i.e. vomiting and diarrhoea). Without appropriate management, this may lead to     reduced nutritional intake, increased nutritional losses and risk of malnutrition in patients     who may already have elevated nutritional requirements due to their clinical conditions.      Poor tolerance to standard feed formulations can be managed with extensively hydrolysed     (peptide-based) enteral feeds, where the protein source is provided in smaller proteins.     Patients with elevated nutritional requirements, poor tolerance, maldigestion and/or     malabsorption often require a higher energy, higher protein feed to meet their nutritional     requirements in a smaller volume of feed.      The study feed is a high energy (1.5kcal/ml), high protein (7.5g protein/100ml) peptide-based     feed, available as a 500ml enteral tube feed, and a 200ml Vanilla-flavour oral nutritional     supplement. The study will investigate the gastrointestinal tolerance, compliance and     acceptability of the high energy, high protein peptide-based feed in 60 adult patients     requiring a peptide-based feed, in several NHS sites across England. Patients will be asked     to take the study feed for 28 days. Data will be recorded using questionnaires with no     invasive measures.      The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance,     acceptability, nutrient intake and anthropometry.   "
11119|NCT03140358|"     Study of low dose atropine in preventing the onset and progression of myopia in high risk     children with pre-myopia or low-myopia.   "
11120|NCT03140345|"     The aim of this two-year study is to explore the relationship among function of HVA,     nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques. This     study will not only improve our understanding on the expressions of function of HVA, nailfold     capillaries and tendency of TCM patterns, but also demonstrate the fundamental knowledge of a     novel healthcare model on hemodialysis vascular access.   "
11121|NCT03140332|"     Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced     forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a     multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not     to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response     should be performed with mRECIST criteria that are significantly better correlated with     survival. These criteria take into account the tumor size and also the modification of the     tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate     tumor control rather than tumor response since sorafenib is more stable than tumor response.      This evaluation will be made according to the mRECIST criteria after 3 months of treatment     since the progression-free survival is of the order of 3 to 4 months. The determination of     early predictive criteria for the response to sorafenib would optimize the management of     advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected     patients, and with undesirable effects and a significant cost. Predictive biological criteria     have already been studied, such as alpha foeto-protein (AFP), whose early decrease with     sorafenib is associated with better overall survival. The same applies to the early reduction     at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner     appears to be an accessible and reproducible choice imaging technique for assessing tumor     vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor     perfusion prior to treatment with sorafenib were predictive of better control of the disease     and even a better tumor response according to the RECIST 1.1 criteria. The determination of     pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall     survival has never been studied in advanced CHCs. On the other hand, an early variation in     the criteria for tumor perfusion under treatment would tend to be correlated with the tumor     response and even with overall progression-free survival.      Therefore, the study of tumor vascularization by the perfusion scanner could make it possible     to demonstrate early predictive criteria for tumor control under sorafenib in order to     optimize the management of patients with advanced HCC.   "
11122|NCT03140319|"     The study evaluated the safety and efficacy of the Autologous cultured fibroblast for     correction of Nasolabial folds and inhibition of skin aging   "
11123|NCT03140306|"     This study aims to assess the use of low dose CT reconstructed with MBIR for the assessment     of patients with inflammatory bowel disease who need CT to assess for disease complications.   "
11124|NCT03140293|"     Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This     procedure is associated with anxiety and fear of pain that can be expected during the     procedure, often prejudicing patients against this definitive antenatal testing. It is     important to determine if different approaches to pain and anxiety reduction are effective.     Currently there is no randomized study to evaluate the efficacy of analgesia for pain     reduction during chorionic villous sampling. Multiple studies have been published suggesting     that analgesia during the similar procedure of amniocentesis does not significantly reduce     pain scores.   "
11300|NCT03137979|"     This study is to evaluate the safety and efficacy of Gingiva Mesenchymal Stem Cell Therapy     for Chronic Adult Periodontitis.   "
11126|NCT03140267|"     Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from     mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning     in intensive care have been performed, with inconsistent results, utilizing different methods     of IMT in different populations.      To perform the best IMT program, we need to know the physio-pathology of the diaphragm in     difficult to wean patients.      This study proposes to discriminate the two main characteristics of the inspiratory muscles:     strength and endurance.      By analyzing the evolution of strength and endurance during all the weaning period, we want     to know which characteristic has the more deficiency to adapt in a second time an effective     program of IMT.   "
11127|NCT03140254|"     The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic     for preoperative skin preparation   "
11128|NCT03140241|"     After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to     nociceptive stimulation perioperatively.   "
11141|NCT03140072|"     In this integrated, multi-part, Phase I study, the safety, tolerability, food effect,     pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of     AZD9898 will be investigated.   "
11129|NCT03140228|"     Sore throat is minor but well recognized complaint after receiving general anaesthesia. It is     rated as 8th most undesirable outcome in postoperative period.It not only affects the     patient's satisfaction but also can affect patient activities after leaving hospital.      Many factors can contribute to postoperative sore throat and the incidence has been found to     vary with the method by which airway is managed.      The study is conducted to compare the severity and frequency of postoperative sore throat in     children undergoing elective surgery following the use of AmbuAuraOnce LMA and I-Gel. The     study will be done in children who are able to self-report the severity of sore throat.      This study will help us to determine which supraglottic device (I-gel vs. AmbuAuraOnce LMA)     is better in terms of causing less complication spells of sore throat. The use of such device     will not only reduce the severity and frequency of postoperative sore throat that may affect     the activities of patient after leaving hospital but also will improve satisfaction level of     patient and parents.   "
11130|NCT03140215|"     The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD)     Baska to the I-Gel , regarding seal pressure, fitting on the larynx (detected by     Fiberoptic) & complications. The study will be done for females undergoing minor     gynecological procedures under general anesthesia with spontaneous ventilation.   "
11131|NCT03140202|"     Context: Chest compressions quality is known to be essential in cardiopulmonary     resuscitation. Despite a known harmful effect of chest compressions interruptions, current     guidelines still recommend provider switch every 2 minutes. Feedback impact on chest     compressions quality preservation during cardiopulmonary resuscitation remains to be     assessed.      Study design: simulated prospective monocentric randomized crossover trial.      Participants and methods: Sixty five professionals rescuers of the pre-hospital care unit of     University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed     continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a     feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by     reached target of rate, depth and leaning at the same time (recorded continuously).      Hypothesis: Feedback device preserve chest compression quality above the 2 minutes     recommended switch over during cardiopulmonary resuscitation.   "
11132|NCT03140189|"     Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer.     It is generally accepted that comparing to open resections, MIE results in decreased     postoperative pain, faster recovery times, and shorter hospital stays with comparable     oncologic outcomes. However, MIE poses an important challenge for established thoracic     surgeons as it is a difficult technique to become skilled at with an protracted learning     curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite     freedom of movement with a two dimensional visualization of the operating field. Such a     difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic     anastomosis is needed.      Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot-     assisted surgery offers some advantages including high- definition three- dimensional     visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling,     and tremor filtration, allowing the surgeon to perform complex operations comfortably in the     domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted     thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the     published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim     of this study was to investigate the short- term and long-term outcomes of RAILE to identify     any clinical or oncologic benefits of RAILE in esophageal cancer.   "
11133|NCT03140176|"     OPTIMISE is designed to provide knowledge regarding the use of Sunitinib as 1st line     treatment and 2nd line treatment selected (Sunitinib-different sequence) with respect to     efficacy outcomes, adverse events, and health related QoL in the real life setting.   "
11134|NCT03140163|"     The ULTRACHEST study will be a prospective clinical diagnostic performance study with primary     objective to establish device diagnostic clinical performance of Ultra Low Dose CT (ULD-CT)     in order to prove it is more accurate in detecting pneumonia when comparing to standard     conventional chest radiography.   "
11135|NCT03140150|"     Follow-up strategy for patients implanted with a pacemaker.   "
11136|NCT03140137|"     The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing     autoimmune conditions. This retrospective nation-wide study will assess their tolerance in     patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors     for an advanced cancer in clinical practice.   "
11188|NCT03139461|"     The goal of the study is to develop and test an intervention toolkit to increase the     enrollment in EnhanceFitness (an evidence-based group physical activity program for older     adults) at Young Men Christian Association (YMCA) sites through physical therapist referrals.      A cluster-randomized trial will be used to compare current and intervention toolkit     approaches to generating enrollment in EnhanceFitness at YMCAs. The objective of this trial     is to compare the effectiveness and cost of the current approach for generating enrollment in     EnhanceFitness (business as usual or control arm) with the intervention toolkit that YMCA     staff will use to engage physical therapists to refer their older adult patients to     EnhanceFitness (the intervention).   "
11137|NCT03140124|"     Several studies have noted the benefits of exercise programs in improving both mood and     anxiety symptoms. Additionally, single bouts of exercise have been shown to improve mood and     anxiety. Business applications report ancillary benefits of exercise as well. For example,     individuals spontaneously report better ability to approach stimuli and cope with emotional     experiences if doing it while exercising.      The current study aims to investigate exercise during a therapy session as a potential     intervention for enhancing therapeutic learning, particularly ability to better cope with     emotional topics and experiencing intense emotions. In this study, patient participants will     complete a therapy session while using an exercise machine and a separate therapy session     while using a worry stone (control). Both patient participants and therapist participants     will make ratings of a variety of items, including ability to discuss emotional topics and     comfort in experiencing emotions.      Investigators hypothesize that patients will report better ability to discuss emotional     topics and more comfort in experiencing emotions following the exercise condition as opposed     to the worry stone condition. Investigators also hypothesize that therapist ratings will     similarly indicate that patients were better able to discuss emotional topics and experience     emotional content during exercise sessions.   "
11138|NCT03140111|"     Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the     effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary     Sjögren's Syndrome.   "
11139|NCT03140098|"     The aim of this observational study is to evaluate the safety of the guided healing and     adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the     collagen membrane according to the occurrence of peri and post-operative complications will     be evaluated.   "
11142|NCT03140059|"     The aim of this study will be to compare the approach of repeated applications of APDT versus     surgical therapy for the treatment of residual pockets in generalized agressive     periodontitis.   "
11143|NCT03140046|"     Irregular astigmatism is one of the most serious and frequent complications of corneal     refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is     also considered as one of common, serious complications of corneal injuries .      Spectacle correction is usually not useful in the correction of corneal irregular     astigmatism. Contact lenses represent a good alternative, but their adaptation and stability     are limited by the irregular corneal surface and patient discomfort.      In recent years, advancements in laser technology have offered better tools for dealing with     irregular astigmatism with finding new surgical methods to improve corneal regularity for the     correction of irregular astigmatism.      Topography-linked excimer laser is a potentially effective technique in the treatment of     irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an     effective means of treatment of irregular astigmatism due to different etiologies Such as     corneal Injuries , scar , or postoperative.      Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are     a better astigmatic correction, the possibility of correcting irregular astigmatism, and a     smaller ablation volume compared with standard treatments, resulting in better visual     performance.      Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided     photorefractive keratectomy (PRK) to improve refractive status of patient with irregular     Cornea.   "
11144|NCT03140033|"     Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized     Controlled Trial   "
11145|NCT03140020|"     The aim of this proposal is to investigate the effects of uneventful microsurgical and     endovascular treatment of unruptured saccular non-giant anterior communicating artery [ACoA]     aneurysms on resting state functional connectivity levels of higher order cognitive networks     and to correlate the connectivity levels of these networks with neuropsychological     performance and functional outcome.      This study compares two treatment groups and one control group.   "
11146|NCT03140007|"     Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using     SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and     brushing in patients with indeterminate biliary strictures in the setting of     cholangiocarcinoma.   "
11147|NCT03139994|"     The cause of temporomandibular joint disorders remains unknown. It is considered     multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has     been showed an association: a steeper condylar path, flatter lateral anterior guidance, and     habitual chewing on the symptomatic side. This finding argues the possibility of causation of     some of these characteristics. This double blind longitudinal study aims to assess if the     presence of one habitual chewing side could contribute to temporomandibular joint disorders     over time.      Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one     chewing side (observed and interview); with steeper condylar path and lower lateral guidance     angles will be considered consistent one side chewers, and this side will be considered more     susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular     retrognathia will be considered as secondary pre-specified outcomes. Four years later, both     TMJs of each participant presenting signs and/or symptoms will be evaluated according to     DC/TMD.   "
11148|NCT03139981|"     This is a dose escalation study to test the safety, tolerability and preliminary efficacy of     ASN002 in people with moderate to severe atopic dermatitis (AD).   "
11149|NCT03139968|"     The RECAP-trial is a randomized controlled, double blinded, superiority trial studying the     efficacy of the RADPAD®, a protective drape, that potentially reduces the scattered radiation     received by the operator during diagnostic angiograms and percutaneous coronary     interventions.   "
11150|NCT03139955|"     Bodytrak® is a wireless earpiece which can monitor the user's vital signs such as tympanic     (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably     within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently     in a prototype stage.      The purpose of this study is to assess the feasibility of conducting a trial investigating     the integration of Bodytrak in an NHS (National Health Service) environment at Chelsea and     Westminster Hospital; to collect patient vital sign data for the development of Bodytrak     algorithms to detect the transition point of recovery/deterioration of health, as well as the     level of consciousness; and to obtain nurse and patient feedback regarding their user     experience of Bodytrak.   "
11151|NCT03139942|"     Small growths detected in the colon (polyps) during a colonoscopy may or may not have the     potential to develop into cancer. However, since visual inspection alone cannot separate all     potentially harmful polyps from harmless ones, the standard approach is to remove them all     for histological lab examination, exposing patients to risk of injury and putting a     significant demand on hospital resources. An accurate method of determining polyp type during     endoscopy would enable the clinician to only remove potentially harmful polyps. A new     endoscopic optical imaging probe (OPTIC), which analyses how light interacts with tissue, is     proposed to do this. The probe is contained within a normal endoscope and uses white light     and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light     emitted, along with normal colour pictures of the polyp surface, are measured and recorded to     quantify specific characteristics of each type. Optical measurements of polyps detected in     endoscopy clinics at Imperial College Healthcare NHS Trust will be analysed to determine if     the signal can be used to differentiate different polyp types.   "
11152|NCT03139929|"     To study the reliablity of MSFP and stressed volume to follow volume loading and to predict     fload loading responsiveness in patients after elective coronary artery bypass grafting     (CABG) surgery.   "
11153|NCT03139916|"     This research study is studying a combination of drugs with radiation as a possible treatment     for Glioblastoma.      The drugs involved in this study are:        -  Bavituximab        -  Temozolomide   "
11154|NCT03139903|"     The purpose of this study si to define morphological and epidemiological parameters and     identify new symptoms in French patients with Seckel syndrome (SCKL) or microcephalic     osteodysplastic primordial dwarfism type II (MOPDII).   "
11177|NCT03139604|"     The purpose of this study is to evaluate itacitinib or placebo in combination with     corticosteroids as first-line treatment of participants with Grade II to IV acute     graft-versus-host disease (aGVHD).   "
11178|NCT03139591|"     This study aimed to compare the efficacy between lidocaine inhalation vs intravenous     dexamethasone to reduce pain after laryngeal mask insertion   "
11155|NCT03139890|"     Vascular function decreases following the intake of a mixed meal in some, but not all     studies. Differences in the relative amounts of dietary fat, carbohydrates and protein     present in the mixed-meal challenges may have contributed to these apparently inconsistent     results. Well-designed trials - comparing under rigorously standardized conditions - on the     effects of macronutrients on postprandial vascular function are missing. The primary     objective of the current study is thus to evaluate in overweight and slightly obese men the     effects of the three macronutrients (fat, carbohydrates, and protein) on postprandial     vascular function, as assessed by brachial artery flow-mediated vasodilation (FMD). Secondary     objectives are to examine postprandial effects on other markers reflecting vascular function,     plasma markers for low-grade systemic inflammation and endothelial dysfunction, blood     pressure, and serum lipid and plasma glucose metabolism.   "
11156|NCT03139877|"     Using an observational case-control cohort design, the investigator aims to define the     mechanisms underlying microbiome regulation of metabolism in adolescence before and after     medically indicated therapies for obesity. The investigator's overarching hypothesis is that     gut bacteria control host weight, insulin sensitivity, and response to weight-loss treatments     by modifying host metabolism.   "
11157|NCT03139864|"     The type 1 diabetes is a common chronic disease characterised by the stop of production of     insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the     effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during     exercise of increasing intensity by a comparison with non-diabetic controls children.   "
11158|NCT03139851|"     The investigators hypothesize that the administration of pembrolizumab combined to metronomic     cyclophosphamide may be an interesting therapeutic option for female patients breast cancer     with lymphopenia.      Include only patients with breast cancer with lymphopenia is based on the particularly poor     prognosis of these patients. The approach suggested here is to deplete and active the immune     response of these immunosuppressed patients. The combination of pembrolizumab and     cyclophosphamide would provide a higher gain in anti-tumor response in these patients than in     those without lymphopenia and in chemotherapy alone.      The investigators proposal is to conduct a multicentric, non-comparative, single arm,     two-stage, Phase II trial in lymphopenic patients with metastatic breast cancer.      The study is divided in 2 parts:        -  a safety run-in Phase aiming to evaluate the safety of the combination therapy          pembrolizumab + metronomic cyclophosphamide based on the occurrence of severe          toxicities.        -  a two-stage Phase II aiming to evaluate the clinical activity of the combination therapy          pembrolizumab + metronomic cyclophosphamide.      In both parts of the study, patients will receive cyclophosphamide (50 mg/day, daily, per os)     and pembrolizumab (200 mg every 3 weeks, intravenously [IV]). The adverse events of the two     drugs are well known.   "
11159|NCT03139838|"     This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world     effectiveness of two different electronic health record (EHR) behavioral interventions in     improving a number of patient- and family-centered processes and outcomes of care among     seriously ill hospitalized patients. The investigators hypothesize that outcomes can be     improved without raising costs by requiring intensive care unit clinicians to (i) document a     prognostic estimate and (ii) provide a justification if they choose not to offer patients the     option of comfort-oriented care. To test this hypothesis the investigators will conduct a     30-month trial at 18 intensive care units in 10 hospitals using the same Cerner EHR within     Carolinas HealthCare System.   "
11160|NCT03139825|"     The disruption of social cognition associated with borderline personality disorder (BPD), and     more specifically categorization of facial emotions, remains largely under-studied, despite     the high frequency of this pathology in the clinical population. The first results differ     from the observations made in adults and this confirms the relevance of studying this theme     specifically in adolescence. On the cognitive level, there is a disturbance of the detection     and the categorization of the facial emotions in the TPL. The characteristics of this     disturbance and its possible association with an attack on the connectivity of the brain     remain unknown in adolescence. No functional imaging studies are published in adolescent TPL.     This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and     feasibility data to support a response to upcoming PHRC competitions and eventually offer a     science thesis opportunity.   "
11162|NCT03139799|"     This study aims at investigating the effects of tablet-based puzzle video games on cognitive     function and emotional well-being. This study extends preliminary findings of studies looking     at short-term benefits of playing puzzle video games to a long-term intervention in healthy     older adults and patients suffering from cognitive impairment due to mild cognitive     impairment or acquired brain injury. To this end, the investigators compare two     interventions: A tablet-based puzzle video games experimental intervention and a control     intervention tablet newspaper-reading control intervention. This study uses a 16-week,     assessor blinded, randomized crossover design with two phases of treatment and three waves of     measurement. Participants are randomly allocated to either the experimental or control     intervention for 8 weeks, then interventions are crossed over. Both groups receive both     interventions in opposite order. At three time points (pre-, mid- and post-test) higher     cognitive function and emotional well-being are tested using standardised neuropsychological     tests and questionnaires.   "
11163|NCT03139786|"     The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of     2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to     2% of the population The general rule. BVA may be associated with structural damage to the     ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm     and acute aortic accidents. Recent data from the literature have revealed that the natural     history of BVA is marked by a possible development towards significant valvulopathy and / or     an ascending aortic aneurysm often requiring surgical treatment. However, the natural history     of bicuspid disease remains poorly understood and the prognostic factors for progression to     severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be     determined.   "
11164|NCT03139773|"     The long-term objective of this study is to determine if habitual consumption of high-quality     protein at breakfast will lead to improved energy metabolism and decreased daily energy     intake in normal weight and overweight children. The investigators hypothesize that     increasing protein intake at breakfast will improve energy metabolism and reduce energy     intake throughout the day in overweight/obese school-aged children. The significance of the     study is that improving nutrient intake at breakfast can potentially lead to a future     reduction in childhood obesity rates.   "
11165|NCT03139760|"     POWERSforID is a 24 week randomized control trial designed to assess the feasibility of a     telehealth and coaching intervention for improving health outcomes of adults with     intellectual disability. Recruitment is conducted through a disability health clinic located     in Colorado Springs, CO.   "
11166|NCT03139747|"     This is a Phase 2 Study of Everolimus and Lenvatinib in patients with metastatic     differentiated thyroid cancer who have progressed on lenvatinib alone. Patient will have     imaging, lab test and physical exams   "
11167|NCT03139734|"     The purpose of this study is to find out if sacral neuromodulation is an effective treatment     for pelvic pain associated with surgically treated endometriosis.   "
11168|NCT03139721|"     This study is being conducted to satisfy the post-CE approval requirement.   "
11169|NCT03139708|"     This an interventional study looking at two different sequences of pre-operative eye drops,     to determine which order is more effective in reducing intraocular pressure with pupil     dilation.   "
11170|NCT03139695|"     Mechanical ventilation can be life saving strategy for patients with respiratory failure due     to a variety of reasons. Once the underlying illness has resolved, intensive care doctors     have to take a decision on when the patient is safe to get off the ventilator or be     extubated. They use clinical assessment of the patient's ability to breathe spontaneously and     make use of some breathing parameters to make the judgment. Most of the time, a patient can     come off the ventilator and do well, but sometimes muscle weakness from sickness can affect     the patient's ability to breathe adequately once ventilator support is discontinued. If that     occurs, the patient may have to be put back on the ventilator and the physician will suggest     some changes to help muscles get stronger. A simple, non-invasive test that can assess     respiratory muscle state before taking patients off the ventilator to see if their muscles     look healthy can help distinguish which patients may not be ready to be extubated. There are     currently several tests available to assess muscle strength, in particular muscles that help     in breathing like the intercostal muscles and diaphragm. The study will test the use of     Ultrasonography (Ultrasound) as a non-invasive test to assess the muscles of respiration.     This test will also help the investigators test physical therapies and interventions of     mechanical ventilation that can help patients strengthen the muscles while waiting for     extubation.   "
11171|NCT03139682|"     Traumatic brain injury (TBI) is a leading cause of death and disability around the world. The     social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1     billion per year in Canada- $650 million in care and $580 million in lost productivity. Novel     interventions aimed at TBI-linked molecular targets have been successful in limiting injury     and improving neurologic recovery in animal models, thus providing compelling evidence that     effective intervention is possible after injury. This study proposes to investigate traumatic     microvascular injury (TMI) and specifically blood-brain barrier dysfunction (BBBD) as a     candidate biomarker and therapeutic target in TBI.   "
11172|NCT03139669|"     Invasive cervical cancer incidence and mortality can be dramatically reduced through early     detection and treatment, but many women do not complete screening at recommended intervals.     Many low-income women in Virginia remain uninsured and are at significant risk of being     medically underserved and failing to complete regular cervical cancer screening. At-home     self-collection of specimens for HPV testing is an innovative approach that may increase     access to cervical cancer screening in populations that do not participate in traditional     clinic-based screening. The proposed community based participatory study aims to determine     whether offering at-home self-collection for HPV testing through a lay navigator network is     an acceptable and feasible method to increase access to cervical cancer screening for     under-screened women in the Tobacco Footprint in rural far Southwest Virginia (Health     Districts 1, 2 and 3). The procedures will be recruitment of under-screened women in Health     Districts 1, 2 and 3 of Southwest Virginia to complete HPV testing using self-collection kits     distributed by lay navigators. Regardless of HPV positivity, all women will be provided with     information about cervical cancer screening (locations, cost, etc.), and will be encouraged     to complete Pap screening by a clinician.   "
11173|NCT03139656|"     This study will investigate three interventions—values clarification, planning, or combined     (values clarification + planning)—for increasing goal-consistent health behavior (e.g.,     exercise or dieting). The investigators will also examine how intervention effects differ     based on various psychological and neuropsychological factors, to better understand how     interventions can be tailored to specific individuals.      The investigators hypothesize a) that the combined intervention will increase goal-consistent     exercise behavior more than the other interventions; and b) that individuals scoring higher     on self-concordance or goal-commitment will benefit more from planning, whereas those with     more positive expectancies or scoring higher on neuropsychological measures (e.g., working     memory) will benefit more from values clarification.   "
11174|NCT03139643|"     The current study aims to investigate two potential interventions (i.e., cognitive dissonance     and action planning) for inducing behavior change for behaviors important to college     students—studying and exercise. In addition, this study will investigate factors that may     impact behavior change, such as psychological and neuropsychological variables, to better     understand how to bridge the intention-behavior gap.   "
11175|NCT03139630|"     Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in     HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.   "
11176|NCT03139617|"     This study aimed to evaluate the efficacy of ultrasound guided femoral 3 in 1 block versus     the blind technique single shot fascia iliaca compartment block as an analgesia method in     patients prior positioning for spinal anaesthesia in femur fracture surgery. A total of 60     patients were enrolled and divided equally into 2 groups.   "
11181|NCT03139552|"     This study aims to reduce the amount of sugar in a particular food item and add spices to see     if the food liking of that item rates as high or higher in a post meal survey. Through taste     testing of the menu items (using sequential monadic CLT methodology) the investigators will     determine an opinion of the participants. Results of these surveys will determine whether     participants enjoy the reduced sugar options as much as their full sugar counterparts.   "
11182|NCT03139539|"     This is a randomized, controlled study which aims to show whether iodine impregnated     incisional foil (IobanTM) has a place in the prevention of prosthetic joint infection (PJI).     1200 patients will be included in this study and will be followed through out a ten year     period.      Follow up will center on the function of the prosthetic knee, early and late infection rates     and revision surgery due to aseptic loosening.      Our purpose is to gain insight in to the causes of post-operative infection in joint     alloplasty surgery. Our hypothesis' are:        1. The patient's skin flora is the main source of intraoperative contamination,        2. Intraoperative contamination can be reduced by using IobanTM        3. Intraoperative contamination strongly predicts postoperative infection        4. Unsuccessful clinical outcomes of knee arthroplasty are caused by low-grade infections.      To our knowledge this is the first study with this large a sample size and as long a follow     up.      Background PJI is a devastating complication with substantial morbidity and high socio     economic costs. Revision surgery due to infection costs as much as six times more than the     primary surgery and has a poorer outcome for the patient i.e. disability, pain or loss of     function.      Methods and materials      The study has two main arms:        1. Intraoperative contamination        2. Postoperative infection      The first stage aims to document that patients with intraoperative contamination have a     larger risk of developing postoperative infection and include a study of the effect of     Ioban™.      The second stage are to include methods of PCR (polymerase chain reaction) and fluorescence     microscopy, to demonstrate bacterial contamination and/or infection of any implants removed     during the study period.      Perspectives This study will give us new insight in the causes of PJI and the correlation     with contamination during surgery. If IobanTM is proved to prevent infection it is a simple     way to prevent post-operative infection and can be implemented in any orthopedic department.   "
11183|NCT03139526|"     Craniopharyngioma is a rare, benign central nervous system tumor, which may be a source of     multiple complications, from endocrinology to vision, neurology and neurocognitive functions.     This morbidity can lead to reduced participation in life activities, as described in the     International Classification of Functioning, Disability, and Health (ICF). The primary     objective of this study is to measure participation in life activities in a population of     children affected by childhood craniopharyngioma, using the assessement of life habits     questionnaire (LIFE-H questionnaire), validated as a social participation measurement tool in     various pediatric disabilities.   "
11184|NCT03139513|"     This is a multicentre, ambispective (both retrospective and prospective), and     non-interventional study conducted in France in adult participants with BRAF V600     mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination     with vemurafenib (Zelboraf®).   "
11185|NCT03139500|"     The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of     JNJ61803534 in healthy participants after administration of single ascending oral doses of     JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14     consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other     drugs (Part 3).   "
11186|NCT03139487|"     This is an open label, multi-center, and randomized phase II trial designed to compare the     safety and efficacy of oral rivaroxaban and subcutaneous dalteparin in patients with acute     venous thromboembolism and upper gastrointestinal, hepatobiliary, or pancreatic cancer, based     on a group sequential design. Enrolled patients will be randomized in a 1:1 ratio. Patients     will be stratified by performance status (ECOG performance status 0-1 versus ≥2) and type of     cancer.   "
11187|NCT03139474|"     The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today     gonadotrophins are administered to induce multiple follicular development and controlled     ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone     analogues are co-administered in order to prevent premature luteinizing hormone surges.     Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without     using gonadotrophin-releasing hormone analogues .      Avoiding the adverse effects of elevated luteinizing hormone levels, first     gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin     stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes     gonadotrophin suppression through down-regulation and desensitization of the     gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short     period of gonadotrophin hypersecretion .      Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and     rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing     hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion.     Several advantageous effects of cetrorelix were established , and these effects seemed to be     independent from the type of antagonist used for luteinizing hormone-suppression.The quality     of oocytes and developing preembryos is one of the most relevant factors determining the     success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the     eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing     effects are necessary to know.   "
11189|NCT03139448|"     Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper     airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx     that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also     proven to be more effective than combined oral-nasal ventilation during induction of general     anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for     oxygenation and ventilation in patients undergoing colonoscopy.      The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal     CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of     oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and     standard care with nasal cannula.   "
27867|NCT02920970|"     This study aims to compare the clinical performance and subjective acceptance of the     narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable     basis.   "
11191|NCT03139422|"     Intrauterine contraceptive device is the most commonly reversible method used among women of     reproductive age worldwide. Almost one in five married contraceptive users is currently using     Intrauterine contraceptive device. The Egyptian demographic and health survey results     indicate that 30% of currently married women interviewed in the Egyptian demographic and     health survey were using Intrauterine contraceptive device. Main reasons for discontinuation     of Intrauterine contraceptive device as cited by women were excessive bleeding per vagina     39.68%, abdominal pain 38.62%, low backache35.97%.   "
11192|NCT03139409|"     This study will be conducted to compare the effect of chlorexidine containing adhesive versus     conventional one in prevention of secondary caries lesion underneath composite restoration     over one year follow up null hypothesis   "
11193|NCT03139396|"     Patients with missing back teeth can be restored with an inlay retained bridge.The inlay     retained bridge designs include inlay shaped, tub shaped or proximal box shaped.In this study     a clinical evaluation will be commenced to evaluate two designs the inlay shaped and the tub     shaped.The hypothesis of our trial is that the new design may show longer survival rate due     to less stress applied on the restoration which allow the restoration to function for longer     period as the inlay shaped bridge showed clinical problems during survice.   "
11194|NCT03139383|"     The investigators tested the hypothesis that administration of intravenous dextrose as a     maintenance fluid in gynecologic laparoscopic surgery would reduce the incidence and severity     of postoperative nausea and vomiting (PONV) compared with normal saline solution in the same     dose.      A prospective randomized double blinded controlled study was conducted. Eighty six     participants were randomized to dextrose solution (n= 42) or normal saline solution (n= 44).     The Bellville postoperative nausea and vomiting scores were recorded until 24 hours after     surgery.   "
11195|NCT03139370|"     Participants who are HLA-DPB1*04:01 positive and whose tumors are MAGE-A3/A6 positive may be     eligible for this study. If eligible, white blood cells are collected by apheresis and     genetically modified to recognize cancer cells which express MAGE-A3/A6. Chemotherapy     precedes infusion of the genetically modified cells. Participants may be hospitalized and/or     return to the study doctor for check-ups and medical evaluations. The purpose of the study is     to see if the treatment is safe and effective in treating advanced cancer.   "
11196|NCT03139357|"     Stress and anxiety can worsen quality of life in patients seen in primary care practices.     Patients at predetermined practices age 20-65 receive psychosocial screening instruments for     anxiety and quality of life (GAD7 and SF-12) at six month intervals for twenty-four months as     part of routine care. Assessing anxiety and quality of life every six months will provide     data to analyze whether anxiety and quality of life changes over time.      Patients who consent will also be asked at 6, 12, 18, and 24 months about medical utilization     of behavioral care or any medical care outside of University of Pittsburgh Medical Center in     order to be part of their research record for good clinical care. If patients received any     behavioral treatment, the patient will also be asked questions regarding the helpfulness of     this treatment.      This is an observational characterization study to understand the psychiatric and behavioral     needs of primary care patients. The follow-up questionnaires and medical record information     will look at the rates and predictors of hospitalizations and/ or behavioral health treatment     as a longitudinal way to track these symptoms over time. These resources are critical to     determine the need for embedded behavioral care in primary care settings.   "
11197|NCT03139344|"     Skeletal muscle is the largest endocrine organ in the body, playing an indispensable role in     glucose homeostasis. Spinal cord injury (SCI) prevents skeletal muscle from carrying out this     important function. Dysregulation of glucose metabolism precipitates high rates of metabolic     syndrome, diabetes, and other secondary health conditions (SHCs) of SCI. These SHCs exert a     negative influence on health-related quality of life (HRQOL). New discoveries support that a     low level of activity throughout the day offers a more effective metabolic stimulus than     brief, episodic exercise bouts. The proposed study will translate this emerging concept to     the population of individuals with SCI by using low-force, long-duration electrical muscle     stimulation to subsidize daily activity levels. Recently, we demonstrated that this type of     stimulation up-regulates key genes that foster an oxidative, insulin-sensitive phenotype in     paralyzed muscle. We will now test whether this type of activity can improve glucose     homeostasis and metabolic function in patients with chronic paralysis. We hypothesize that     improvements in metabolic function will be accompanied by a reduction in SHCs and a     concomitant improvement in self-reported HRQOL. The long-term goal of this research is to     develop a rehabilitation strategy to protect the musculoskeletal health, metabolic function,     and health-related quality of life of people living with complete SCI.   "
11199|NCT03139318|"     The primary objective of this study is to evaluate the toxicity profile of GRID therapy using     dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.   "
11200|NCT03139305|"     The main purpose of this study is to examine the effect of prolonged (72 hour) administration     of glucagon compared to placebo on energy expenditure in healthy, non-diabetic, obese     subjects.   "
11201|NCT03139292|"     Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask     Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.   "
11317|NCT03137758|"     This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of     PCUR-101 in combination with androgen suppression therapy in the patients with metastatic     CRPC   "
11222|NCT03139019|"     The relative effectiveness of incentives based on process (e.g. medication adherence) vs.     outcome (improvements in blood pressure) is unknown, leading to the key research question:     Which approach is more effective? The incentive structure for this initiative is based on     best practices in the use of process and outcome measures to address this fundamental     question. A series of incentive designs will be conducted to examine the relative     effectiveness of equivalent value incentives based on process (e.g. attending smoking     cessation counseling sessions), outcomes (e.g. quitting smoking), or a combination of process     and outcomes incentives (e.g. attending smoking cessation counseling sessions and quitting     smoking). This will also provide an overarching framework for assessing the relative     importance of process versus outcome incentives in different contexts and for different     populations.   "
11202|NCT03139279|"     An ideal sedative for colonoscopy should have properties that include: rapid onset and offset     of action, provide cardiopulmonary stability, have minimal adverse effects, and allow for     smooth recovery, and early discharge. Propofol is often used solely because of its rapid     onset and short duration of action---a property which is ideal for a fast recovery and early     discharge in the ambulatory setting. However, the use of propofol has been associated with     undesirable effects such as hypotension, hypoventilation and apnea requiring assisted     ventilation.      Balanced anesthesia, using a combination of medications with different mechanisms of action     can reduce the total amount of each sedative agent used and minimize their side effects while     achieving the desired level of sedation. Dexmedetomidine is one agent that has been used     either alone or in combination with propofol for sedation during colonoscopy. While there are     many advantages to using dexmedetomidine, there is concern that the use of this agent for     sedation during colonoscopy may prolong post-operative recovery time and readiness for     discharge home.      No study has definitively assessed whether the use of dexmedetomidine in combination with     propofol during ambulatory colonoscopy prolongs post-operative recovery time as determined by     the Modified Post Anesthesia Discharge Scoring System (MPADSS).   "
11203|NCT03139266|"     People with CF have elevated rates of anxiety and depression when compared to the general     population. Anxiety and depression can have a negative impact on adherence and disease     self-management, leading to worse CF health outcomes such as respiratory symptoms, functional     capacity, and health-related quality of life (HRQOL).      Project UPLIFT is a group mental health intervention that can be delivered by telephone or     Web, though for this study the intervention will be web based only. Project UPLIFT was     originally developed as a depression treatment and prevention program for people with     epilepsy and was shown to be effective in reducing depression and increasing knowledge and     skills. Recently, Project UPLIFT was revised to help people with CF manage their depression     and anxiety and shown to be apparently successful in a pilot study that included adolescents     and adults with CF.      The goals of this project are to determine the effectiveness of Project UPLIFT in reducing     anxiety and depression in adolescents and adults with CF, as well as increasing their quality     of life and other physical health-related disease outcomes.   "
11204|NCT03139253|"     Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been     recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac     gastric cancer. Strongly evidence supports that H. pylori eradication is an effective     approach to reduce the incidence of those pathologies.   "
11205|NCT03139240|"     Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose     recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared     to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study     will help future providers understand whether prescribing opioids are an important adjunct     for pain control in women undergoing MAB.   "
11206|NCT03139227|"     This pilot clinical trial studies the side effects and best dose of apigenin in increasing     health benefits in high risk breast clinic patients. Celery is high in apigenin, a compound     that may have anti-cancer activities. Eating a celery-based diet may help in prevention and     treatment of inflammatory diseases including cancer.   "
11207|NCT03139214|"     This study aimed to test the effect of a parenting intervention on metabolic syndrome in     African American youth. The investigators hypothesized that a parenting intervention would     produce reductions in metabolic syndrome, particularly for those families that started out     high in difficulties with parenting.   "
11208|NCT03139201|"     The objective of this study is to demonstrate that the OxyAqua silicone hydrogel soft contact     lens could be prescribed as a supportive care for myopes.   "
11209|NCT03139188|"     The course of care of a patient with a cancer whose evolution is pejorative, is marked by     difficult announcements, called bad news. In the palliative phase, prognostic announcements     are at the forefront. Of these, the announcement of a transfer to the Palliative Care Unit     has not been the subject of any specific studies to the best of our knowledge. It therefore     seemed interesting to us to explore the stakes of this particular announcement, a source of     upheaval for the doctor and the patient, by gathering the point of view of each one.      The objective of our study is to analyze the methods of announcing a transfer to the     Palliative Care Unit and the perception of this announcement by the doctor and his patient     with an incurable cancer.   "
11210|NCT03139175|"     Investigate the relationships between temporomandibular disorder and low back pain   "
11211|NCT03139162|"     The project aims at deriving frailty (FI) and complexity (CI) indices from data collected     with the Resident Instrument Assessment - Home Care adapted for Switzerland (RAI-HC). Data     were collected in 2015 by trained nurses in clinical routine with the primary purposes of     health state assessment and individual home care planning. The study consists in a     retrospective secondary analysis of health data from the Minimal Data Set (MDS), used to     derive frailty and complexity indices according to published definitions and guidelines for     index derivation. The analysis further aims at estimating the predictive power of these     indices on undesirable health outcomes (falls, hospitalizations and deaths). The goal is to     provide home care institutions and nurses valid algorithms to compute useful clinical     indicators without additional assessment that the one routinely done with the RAI-HC.   "
11212|NCT03139149|"     This study will compare the results of early surgery after 12 h conservative treatment and 48     h conservative treatment of adhesive small bowel obstruction.   "
11214|NCT03139123|"     Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal     replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of     study having characterized the underlying mechanism of hypotension in this setting. New     diagnostic methods are now available with high reliability to identify hypovolemia as the     underlying cause of hypotension, among which change in cardiac index during passive leg     raising may be the less affected by restrictive validity criteria. A change in cardiac index     greater than 10% during this test is highly predictive of preload dependence, i.e the     probability than cardiac index will increase if cardiac preload increases.      The aim of this study is then to identify, among hypotensive episodes occurring during renal     replacement therapy in Intensive Care Unit patients, the percentage of episodes related to     preload dependence as identified by passive leg raising.   "
11215|NCT03139110|"     Violence in the workplace is becoming a serious phenomenon in the contemporary world of work.     Hospital staff, like any employee working in contact with the public, is particularly exposed     to this violence. In emergency departments, the number of patients treated and their     heterogeneity, the problems of communicating with healthcare professionals, and waiting     times, favor conflict situations. In the already tense context of the emergencies, the     incivilities or violent acts have an impact on the well-being of professionals. In order to     prevent these situations of violence, a solution could be to integrate a professional with     specific skills into the teams to perform mediation functions between caregivers and     patients.      The aim of the study is to evaluate the impact of the presence of a mediator in emergency     services on personal (verbal or physical) attacks on professionals (caregivers, doctors,     administrative staff).   "
11216|NCT03139097|"     This study will establish reference range intervals for the Quantra System, a next-generation     diagnostic platform that provides whole blood coagulation testing at the point-of-care.   "
11217|NCT03139084|"     The development of disease-targeted drugs for the treatment of pulmonary arterial     hypertension (PAH) has significantly improved within the last years. Combining drug products     with different mechanisms of action such as Endothelin-Receptor-Antagonists (ERAs) and     Phosphodiesterase-Type-5-inhibitors (PDE-5-Inhibitors) has become increasingly important for     the treatment of PAH. Recently, the results of the AMBITION study reported that an upfront     combination treatment of ambrisentan and tadalafil immediately after diagnosis leads to a     delayed disease progression. On the other hand, the sequential combination of bosentan and     sildenafil did not show a similar positive clinical effect and this was attributed to a     negative clinically relevant pharmacodynamic drug-drug interaction. Although, recent     guidelines have extrapolated that initial upfront combination treatment follows a class     effect in terms of efficacy and safety, there is an imperative need to support this notion     with other combinations of ERAs and PDE-5-Inhibitors.   "
11218|NCT03139071|"     Coffee is one of the dietary factors associated with cardiovascular disease (CVD) but its     role in the cardiovascular system is not yet clear. Moreover, available evidence for the     relation between coffee intake with subclinical atherosclerosis is limited and inconsistent.     The aim of this study was to evaluate the association between habitual coffee consumption and     the presence of subclinical atherosclerosis measured as coronary artery calcium (CAC) in the     Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). This is a cross-sectional study     based on baseline data from participants of the cohort ELSA-Brasil. In this analysis, only     participants living in São Paulo with no prior history of CVD aged 35 to 74 years who     underwent a CAC measurement (n=4,426) were included. Dietary data were collected using a     validated food frequency questionnaire. Coronary calcification was detected with computed     tomographic and it was expressed as Agatston units. CAC was further categorized as 0 or >0,     and <100 or ≥100.   "
11219|NCT03139058|"     Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).     Among patients with VADS cancer, more than 60% reported daily alcohol consumption of more     than 20 g / d. Such poisoning can be harmful, causing histological lesions of alcoholic liver     disease, such as steatosis, alcoholic hepatitis, liver fibrosis and cirrhosis. In a     population consuming more than 50 g of alcohol per day for 5 years, the prevalence of severe     hepatic fibrosis is between 30% and 40%. In the therapeutic management of a cancer of VADS,     the presence of cirrhosis is a prognostic element, increasing the postoperative risk of     haemorrhage, surgical site infection and acute renal failure. The search for cirrhosis in the     pre-therapeutic assessment is therefore important. The diagnosis of cirrhosis is not a     problem when clinical, biological, radiological or endoscopic signs of hepatic insufficiency     or portal hypertension are present. Asymptomatic cirrhosis is more difficult to diagnose     without liver biopsy. Noninvasive hepatic exploration techniques have recently been developed     and validated for the evaluation of liver fibrosis in the context of alcoholic liver disease.     Fibroscan® (Echosens, Paris, France) is an imaging device for measuring the liver hardness     (hepatic elasticity expressed in kPa), with a strong correlation with the presence of     histological fibrosis of the liver. At the threshold of 19.5 kPa, Fibroscan can be used to     diagnose cirrhosis with good diagnostic performance (Se 80%, Sp 90%, VPP 93%, VPN 70%) and     good inter- and intra-observer reproducibility. Elastometry is a simple, reliable and     non-invasive tool to systematically evaluate hepatic fibrosis in patients with VADS cancer.     The examination can be performed during a routine care consultation. The post-therapeutic     morbidity induced by cirrhosis in the cancers of VADS is not well known and there is no     recommendation in France about the hepatic explorations to be carried out during the initial     assessment of these neoplasias. It is essential to be able to specify this morbidity in order     to adapt if necessary the therapeutic strategy of cancers of VADS.      The objective of this study is to systematically determine the presence of cirrhosis and / or     liver fibrosis in patients with VADS cancer, in order to investigate their impact on the     morbidity after treatment of squamous cell carcinomas of the head and neck.   "
11220|NCT03139045|"     Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered     cutaneous alteration and venous capital associated with age poses problems of comfort and     quality of life of elderly patients hospitalized. There is little data from the literature     that highlights the difficulties of venipuncture in the context of old age. New venous     visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV)     have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV)     route.   "
11221|NCT03139032|"     The purpose of this phase 2a, proof of concept, open-label clinical study is to evaluate the     efficacy and safety of etrasimod (APD334) in inflammatory bowel disease patients with active     skin extra-intestinal manifestations.   "
11232|NCT03138889|"     This study is to assess the safety and tolerability, determine the recommended Phase 2 dose,     and assess the preliminary clinical benefit of NKTR-214 when combined with atezolizumab     (Tecentriq) in select patients with urothelial bladder cancer or metastatic non-small cell     lung cancer. Both drugs target the immune system and may act synergistically to promote     anticancer effects.   "
14317|NCT03098056|"     The study evaluated and the safety, tolerance and acceptability of a lifestyle modification     program with nutritional supplementation in generally healthy overweight subjects with     cardiometabolic risk factors. Experience will be compared to a historical controls.   "
11223|NCT03139006|"     Cardiovascular disease remains the leading cause of morbidity and mortality worldwide.     Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured     fractional flow reserve (FFR) is currently used for ruling out significant coronary artery     disease. FFRCT is a novel non-invasive technique in which FFR is derived from CT images,     however this method is currently, just like CCTA, lacking specificity. Spectral Detector CT     (SDCT) is a novel technique whereby a spectrum of monoenergetic images at different     kiloelectron Volt (keV) values (40 to 200 keV) can be reconstructed. By using these     monoenergetic images, a decrease in blooming and beam-hardening artifacts could be achieved.     In addition, SDCT offers the opportunity to assess myocardial iodine distribution and     quantification. When combining these factors, we hypothesize more accurate information will     be available about the coronary anatomy, degree of stenosis and FFRCT and thereby contribute     to a more accurate way for the detection of hemodynamic significant stenosis. Therefore, the     aim of this study is to assess the accuracy of SDCT as a non-invasive way for the detection     of hemodynamically significant coronary artery stenosis.      Objective: The overall objective of this project is to assess the accuracy of SDCT for the     detection of flow limiting stenosis in the coronary arteries using invasive FFR as the     standard of reference. Whereby different subaims (e.g. improvement of FFRCT) are made to     answer the overall objective. The secondary objective is to determine the decrease of calcium     blooming of calcifications and beam-hardening artifacts and the improvement of myocardial     blood volume quantification on SDCT in comparison with conventional CT.   "
11224|NCT03138993|"     This study evaluates the feasibility of conducting a randomized controlled trial that tests a     patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed     obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will     use a patient decision aid, while the other half will receive general information about     sleep.   "
11225|NCT03138980|"     The objective of the proposed research is to conduct user testing of a mobile-based     self-management support intervention for adolescents and young adults with Irritable Bowel     Syndrome (IBS), a chronic digestive condition. The application (app; BodiMojo Buddy) uses a     virtual coach that can serve to increase patient engagement through interactive     skill-building, self-care, and mindfulness-based cognitive behavioral activities. If the     BodiMojo Buddy mobile app is successful, it will have a significant public health impact by     providing a mobile resource to the 10-15% of the US population who suffer from IBS and     potentially improving health outcomes and reducing significant costs to the US healthcare     system.      Study participation involves participants downloading and using the app for 30 days. During     the 30 days, participants will interact with the app by inputting their current mood,     receiving supportive feedback from the app, reading messages, and doing brief activities     (such as relaxation activities, etc.). Before and after the 30 days of user testing,     participants will complete a few brief questionnaires about their behavior, how their     symptoms affect their life, and how they receive support from others. These questions will     take around 20 minutes to complete at each administration.   "
11226|NCT03138967|"     The goal of this clinical research study is to determine whether using sugammadex, given with     a standard muscle relaxation drug during bladder surgeries, improves anesthesia conditions     and recovery time.      During some bladder operations, participant's muscles must be completely relaxed. Muscle     relaxation drugs cause the muscles to relax, including the respiratory muscles, and as a     result artificial ventilation is needed to help participant breathe. Sugammadex and other     standard drugs reverse the effect of the muscle relaxation drugs, allowing participant to     breathe on participant's own after the operation.   "
11227|NCT03138954|"     The aim of the study will be to determine the diagnostic and prognostic value of     elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound     exploration of deep pelvic endometriosis.   "
11228|NCT03138941|"     Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective     study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the     attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus     Erythematosus (SLE).      SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence     of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked     loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical     manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe     manifestations of SLE are the accrual of irreversible organ damage, especially renal and     central nervous system (CNS) involvement. As there is no effective targeted monotherapy for     SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum     immunosuppressive therapies. Despite combination therapy with current drugs, many studies     show that the majority of patients suffer inadequate disease control and inexorably accrue     permanent organ damage over time.      The diversity of clinical features of active SLE has made quantification of disease activity     problematic. Although there are a number of published systems in use to measure SLE disease     activity, there are widely acknowledged problems with these instruments. Published     definitions of remission are so stringent that they are met by less than 5% of patients. This     lead to the realisation that rather than lupus remission, a lupus low disease activity state     target may be more feasible, and that patients with low disease activity are more homogeneous     than patients with active disease. Thus, the development of a definition of lupus low disease     activity, which is feasible and has face validity, escapes the complexity of attempts to     quantify heterogeneous states of active disease.      In this study, the investigators will prospectively collect longitudinal data on consecutive     SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage     accrual as the primary endpoint.   "
11229|NCT03138928|"     Purpose: To report the follow-up data for patients who had XEN45 gel stent implantation, a     new method of minimally invasive glaucoma surgery (MIGS).      Material and Methods: Fifteen eyes of fifteen patients who had XEN45 gel stent implantation     surgery were investigated in the study. All the patients were examined preoperatively and at     the following postoperative time points: 1 day; 1 and 2 weeks; and 1, 2, 3, 6, and 12 months.     Intraocular pressure (IOP) was measured by Goldmann applanation tonometry. Combined surgical     procedures (XEN 45 + phacoemulsification + intraocular lens) were performed in the cases that     had cataracts in addition to glaucoma.   "
11230|NCT03138915|"     This is a prospective, multi-center trial conducted at 10 high-volume liver centers in China     designed to determine the diagnostic performance of radiomics-based hepatic venous pressure     gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive     assessment of the clinically significant portal hypertension (CSPH) in patients with     cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by means of     catheterization of a hepatic vein with a balloon catheter is the gold-standard method to     assess the presence of CSPH, which is defined as HVPG≥10 mmHg.   "
11273|NCT03138330|"     The purpose of this study is to collect nutritional information from young children aged     15-36 months to validate a newly developed food frequency questionnaire.   "
11233|NCT03138876|"     Altered mental status (AMS) is one of the most common reasons for inpatient neurology     consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential     diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour     of seizure activity, making rapid identification and treatment of NCSE of great clinical     importance. Currently, an electroencephalogram (EEG) technologist must be called in from home     during non-workday hours in order to obtain a stat EEG. The investigators propose the time     required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid     placement of an EEG cap by the onsite neurology residents.   "
11234|NCT03138863|"     Subjects to be enrolled in this study are pregnant women whose unborn baby has been diagnosed     with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect occurring early in     pregnancy. It is characterized by the development of a hole in the diaphragm, the breathing     muscle that separates the chest from the abdomen. As a result, the intestines and other     organs in the baby's abdomen can move into the chest and press on the developing lungs. CDH     is a serious condition which prevents the fetal lungs from developing normally.      The purpose of this study is to gather information on the safety and effectiveness of a new     procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO). FETO involves two surgical     procedures while the mother is still pregnant. During the early third trimester of pregnancy,     a special tiny balloon is placed in the baby's trachea. After the balloon has been in place     for several weeks, the balloon will be removed during a second procedure, generally done when     the baby has reached about 34 weeks gestation.      The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed     with severe CDH. If better lung development can be promoted, it is expected that overall     survival of babies with severe CDH after birth will also be improved.   "
11235|NCT03138850|"     The purpose of this study is to compare the effect of mandibular advancement bite block and     high flow nasal cannula to standard bite block for oxygenation, capnographic measurement,     prevention of hypoxemia, intervention events and adverse effects during endoscopic     examinations.   "
11236|NCT03138837|"     assess diagnostic performance of 3-Tesla DW-MRI in detecting and staging bladder cancer and     potential role of the ADC value as a biomarker reflecting histological grade and stage.   "
11237|NCT03138824|"     Compare the therapeutic utility of SPIES assisted TURB with WLI assisted TURB in patients     with non-muscle invasive bladder cancer.   "
11238|NCT03138811|"     This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled,     parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild     stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive     multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose     cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two     parts, Cohort 2a and 2b   "
11239|NCT03138798|"     Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal     delivery. However, this practice may lead to either operative delivery (vacuum or forceps     assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited     evidence suggests that dental support devices (DSD) may improve lead to shortened labor by     allowing patients to push more effectively.   "
11240|NCT03138785|"     In this study, investigators want to find the effect of adjuvant collagen cross-linking in     the treatment of fungal keratitis   "
11241|NCT03138772|"     This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis     and healthy controls for a period of two years. This study will include monitoring the     subjects lung clearance index (by performing a breathing test called the multiple breath     washout), as well as spirometry and their respiratory symptoms every three months as well as     during a pulmonary exacerbation and after their recovery.   "
11242|NCT03138759|"     The primary objective of this trial is to assess the effect of probenecid on the     pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.      Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in     combination with probenecid.      Participants will be confined to the clinic for approximately 32 days. Blood samples will be     collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h)     post dose.   "
11243|NCT03138746|"     In a recent series of studies performed by our group, we have shown that exposure to     hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects with     type-2 diabetes (T2DM) and in obese and overweight men without diabetes. The aim of this     study is to investigate the relationship between pressure and oxygen in producing this     effect, specifically, is this effect measurable in hyperbaric air or is some higher pressure     of oxygen required?      Aims:        1. To determine whether the insulin sensitising effect of HBO is apparent in hyperbaric air          at the same pressure as HBO.        2. To examine mechanisms underpinning the increase in insulin sensitivity following HBO.   "
11244|NCT03138733|"     The purpose of this study is to compare the efficacy and safety of ceftobiprole medocaril     versus a comparator in the treatment of patients with complicated Staphylococcus aureus     bacteremia.   "
11245|NCT03138720|"     The purpose of this study is to determine if the combination of paclitaxel protein bound,     gemcitabine, cisplatin, paricalcitol are effective in individuals with resectable and     unresectable pancreatic cancer.   "
11246|NCT03138707|"     Emergency services are a crowded and chaotic environment.   "
11247|NCT03138694|"     Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by     our team has shown the benefits of conservative treatment with only BHCG (Beta-Human     Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self     resolution without the need for any further medical intervention. In addition, our working     hypothesis is that this process in contrast to Methotrexate is a more physiologic one with     less inflammatory and necrosis reaction.      OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of     women treated with Methotrexate and those that had a self resolution process of their ectopic     pregnancy.      Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in     contrast to being stable or decrease in size with conservative treatment.   "
11274|NCT03138317|"     Study was designed to evaluate efficacy of autologous platelet rich plasma (PRP) injections     guided by ultrasound for treatment of knee osteoarthritis.   "
11248|NCT03138681|"     This is a preliminary, double-blind clinical trail aimed to investigate whether the     combination of fluoxetine with ATP or phosphocreatine has a rapid antidepressant effect. 42     patients with major depressive disorder (Hamilton Depression Rating Scale (HAMD) score >= 20)     will be recruited and divided into 3 groups randomly. This study involves two periods. In the     first period, one group will be treated with fluoxetine and placebo, one with fluoxetine and     ATP, and one with fluoxetine and phosphocreatine for 2 weeks. Placebo, ATP and     phosphocreatine will be given intravenously, and fluoxetine orally. In the second period,     each patient will be only given fluoxetine for 4 weeks.   "
11249|NCT03138668|"     The purpose of this study is to investigate and describe the anatomical differences in     distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous     Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in     THA (Total Hip Arthroplasty). Furthermore, we examine any loss of motor function in Musculus     Quadriceps due to posible involvement of the Femoral Nerve. This trial will be conducted in     healthy volunteers, as a blinded, randomized, paired trial.   "
11250|NCT03138655|"     The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and     tolerability in pediatric participants with moderately to severely active ulcerative colitis     or Crohn's disease.   "
11251|NCT03138642|"     In China, mucosal melanoma of head and neck (MMHN) account for 30-40% of all melanoma and the     incidence is on the rise. The prognosis of MMHN is poor with the 5-year survival in a range     between 20-30%. The evidence for the treatment of MMHN was weak since large-sample clinical     researches are rare and no prospective clinical trial is reported. Surgery is the primary     treatment modality for MMHN. However, it is difficult to extend the necessary surgery range     for MMHN due to its limitation of being adjacent to the important anatomical structure in     head and neck or by the considerations of the protection for organ function. As a result, the     recurrence rate for surgery along was over 50%. Radiotherapy(RT) is the main approach for the     multidisciplinary treatment for MMHN. Benlyazid et al. conclude the data from 13 centers and     find that compared to surgery alone, the addition of post-surgery RT improve the survival;     The 5-year locoregional failure rate for the surgery alone group and the RT+surgery group     were 55.6% and 29.9%, respectively. Currently, the research into the prognosis factors is     spare for the non-metastatic MMMHN received extended resection to primary tumor. It is     necessary to undertake a prospective observational clinical research for MMHN in the endemic     area to recognize the risk distribution in this cohort of patients and provide the evidence     to improve the stratification treatment strategies in the clinic.   "
11252|NCT03138629|"     This is an expanded access program (EAP) for eligible participants. This program is designed     to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory     agency. Availability will depend on territory eligibility. Participating sites will be added     as they apply for and are approved for the EAP. A medical doctor must decide whether the     potential benefit outweighs the risk of receiving an investigational therapy based on the     individual patient's medical history and program eligibility criteria.   "
11253|NCT03138616|"     Vitamin D deficiency are related to insulin resistance and impaired beta-cell function.It is     reported that the level of vitamin D is lower during pregnancy and postpartum in the women     with Gestational Diabetes Mellitus. The investigators hypothesize that vitamin D     supplementation to women after birth with previous gestational diabetes may improve glucose     metabolism.   "
11254|NCT03138603|"     The purpose of this research study is to test if a commonly used, FDA-approved medication,     called metoprolol, given during and after surgery, reduces the possibility of heart related     complications in patients with CAD.   "
11255|NCT03138590|"     The purpose of this study is to investigate whether it is possible to accelerate learning and     improve associative memory performance in healthy subjects, by applying transcranial Direct     Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate     learning task   "
11256|NCT03138577|"     This clinical trial is for subjects undergoing right upper extremity surgery. The aim of the     study is to investigate the dose-response relationship between local anesthetic volume and     ipsilateral hemidiaphragmatic paresis (HDP) in patients getting ultrasound-guided     supraclavicular brachial plexus blocks in a blinded, prospective trial.   "
11257|NCT03138564|"     Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset     of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of     patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by     patients and their surrogates with sufficient time to consider alternatives such as hospice     or dying at home. Over the last decade, the researchers have developed and iteratively tested     a patient and family-centered advance care planning intervention based on the     Representational Approach to Patient Education called Sharing Patient's Illness     Representation to Increase Trust (SPIRIT). SPIRIT is a 6-step, 2-session, face-to-face     intervention to promote cognitive and emotional preparation for end-of-life decision making     for patients with ESRD and their surrogates. In these explanatory trials carried out in     dialysis clinics, SPIRIT was delivered by trained research nurses. The researchers have     established feasibility, patient-surrogate acceptability, and efficacy. Patients and     surrogates participating in SPIRIT showed significant improvement in preparedness for     end-of-life decision making, and surrogates in SPIRIT reported significantly improved     post-bereavement psychological outcomes after the patient's death compared to a no treatment     comparison condition. The logical, critical next step is to ask: Will SPIRIT be effective as     part of routine care in real-world settings with less control? To address this very issue,     The researchers will conduct a real-world effectiveness-implementation study. This study is a     multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT     delivered by dialysis care providers as part of routine care in free-standing outpatient     dialysis clinics compared to usual care plus delayed SPIRIT implementation. This study will     evaluate the implementation of SPIRIT, including sustainability.      The researchers will recruit 400 dyads of patients at high risk of death in the next year and     their surrogates from 30 dialysis clinics in 4 states. Patients and surrogates will complete     questionnaires at baseline and after the intervention; all participants will be followed for     up to 9 months.   "
11258|NCT03138551|"     This study will examine the feasibility and preliminary effects of the Mealtime PREP     (Promoting Routines of Exploration and Play) intervention package for young children with     Sensory Food Aversions and their parents.   "
11259|NCT03138538|"     The purpose of this study is to determine the maximum tolerated dose (MTD), safety,     tolerability, Pharmacokinetic and antitumor activity of M8891 as single agent in subjects     with solid tumors.   "
11275|NCT03138304|"     The objective of this study is to measure the duration of two different types of     interventions to change physician decision making in trauma triage: a video game and an     educational program.   "
14355|NCT03097549|"     The purpose of this study is to determine whether a comprehensive treatment programme for     self-management of mixed and urgency urinary incontinence via a mobile app is effective.   "
11260|NCT03138525|"     The purpose of this study is to assess effects of B cell depletion on the immune system in     patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will     be done by collecting blood from patients starting treatment with ocrelizumab before the     first infusion and before the infusions at 6 and 12 months. The effects on the immune system     will be assessed by performing transcriptome profiling of immune cells, measuring serum     levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays.     In addition, blood will be collected once from a group of healthy individuals to serve as     controls.   "
11261|NCT03138512|"     The purpose of this study is to determine whether the combination of nivolumab and ipilimumab     is safe and effective for delaying or preventing recurrence of cancer in patients who have     experienced the partial or entire removal of a kidney   "
11263|NCT03138473|"     The investigators want to assess the use of the residual SYNTAX score and the SYNTAX     Revascularization Index as predictors for in-hospital outcomes and mid-term (6 months to 1     year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of     STEMI or NSTEACS. Both values will be calculated in a number of patients over one year, and     the relationship between both values and patient outcomes will be evaluated.   "
11264|NCT03138460|"     Data of patient reported outcomes (PRO) are collected during treatment with various pain     alleviation methods (drugs or substances)   "
11265|NCT03138447|"     The digital health tool is an application (app) available on iOS and Android enabled mobile     phones. Health Care Providers (HCPs) configure algorithms which can be tailored to     individual patient's needs and then prescribe the app to support optimal basal insulin     titration and dosing. In this study, participants will be recruited from a medical practice     in which an HCP has prescribed a once-daily basal insulin. Participants will be trained on     the use of the app utilizing their own mobile phone. During training, a brief self-assessment     survey will be administered. After 90 days of usage, a telephone survey will be conducted.     The baseline A1C results and the end of study A1C results will be collected from the     patients' routine clinical care records. Data from the retrospective control group will be     collected from a chart review of the same practice.   "
11266|NCT03138434|"     This study aims to determine whether advanced MRI sequences can provide robust and clinically     relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study     outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and     intraluminal thrombus inside AAA.      Robustness of these MRI sequences will be determined with testing of feasibility and     reproducibility. Clinical relevance will be assessed by studying the association between the     primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.      It is our hypothesis that these parameters are significantly related to disease severity and     may therefore be future markers of disease progression.   "
11267|NCT03138421|"     This study will determine the safety and tolerability of ABX-1431 in patients with central     pain when added on to background pain therapy.      During the course of this study, each participant will take a daily dose of 20 mg of ABX-1431     or a matching placebo for approximately 7 to 9 weeks.   "
11268|NCT03138408|"     This is a multicenter, first-in-human study of SC-004 in participants with advanced solid     cancers. This is a two-part study consisting of Part A (dose regimen finding) followed by     Part B (dose expansion). Part A will involve dose escalation to define the maximum tolerated     dose (MTD) and/or recommended Phase 2 dose (RP2D) and schedule. Part B will enroll additional     participants who will be treated with a study drug dose at or below the MTD determined in     Part A.   "
11270|NCT03138382|"     There is an ongoing and worsening problem with obesity in the developed, and much of the     developing world. Although it has long been realized that Western diets that are rich in     sugar and fat play an important role in this, it has only recently been realized that     exposure to these diets, particularly in childhood, can damage the part of the brain that     determines how much fat there is in the body. The result of this damage is that the so-called     set-point for fat in this part of the brain is pushed upwards. There is a lot of evidence     from animals that activating the brain's balance (vestibular) system pushes this set-point     for fat downwards to cause fat loss, probably because this tricks the brain into thinking     that there is increased physical activity. The aim of this study is to see whether     non-invasive electrical stimulation of the vestibular system in human participants causes a     change in metabolism of fat and/or energy expenditure, which, if regulated upwards, would     suggest this could be used as a means of reducing body fat in humans.   "
11271|NCT03138369|"     There is an ongoing and worsening problem with obesity in the developed, and much of the     developing world. Although it has long been realized that Western diets that are rich in     sugar and fat play an important role in this, it has only recently been realized that     exposure to these diets, particularly in childhood, can damage the part of the brain that     determines how much fat there is in the body. The result of this damage is that the so-called     set-point for fat in this part of the brain is pushed upwards. There is a lot of evidence     from animals that activating the brain's balance (vestibular) system pushes this set-point     for fat downwards to cause fat loss, probably because this tricks the brain into thinking     that the animal is more physically active. The aim of this study is to see whether the same     effect can be triggered in humans by non-invasively stimulating the vestibular system with a     small electrical current through the skin behind their ears.   "
11272|NCT03138356|"     In this integrated, Phase I study, the safety, tolerability, food effect, and pharmacokinetic     (PK) properties of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin     XR and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects     will be investigated.   "
11276|NCT03138291|"     Issue: The prevalence and severity of sleep-disordered breathing increases during pregnancy     due to weight gain, physiological and hormonal changes. These sleep breathing disorders have     a negative impact on perinatal health for both the mother and the child.The optimal treatment     of obstructive sleep apnea in pregnancy is unknown. Although CPAP therapy is often the     treatment of choice, the mandibular advancement appliance would be an interesting alternative     to solve the matter.      Objectives: The main objective of this pilot study is to evaluate the feasibility of     mandibular advancement device to treat sleep apnea during the 2nd and 3rd trimesters of     pregnancy. Secondary objectives will be tools to plan a future randomized controlled trial to     determine the efficacy of this treatment.   "
11277|NCT03138278|"     It is known from extensive documentation that second victims in critical illness often are     the care givers of the patients: family, friends or other persons. Although this has not been     specifically studied in the very old patients, there is no reason to believe that this group     will be different from other ICU patients. Even more so, in this very old age patient group     there are seldom any older relatives. Partners, like wife/husband or other cohabitants, may     be dead or themselves incapacitated. Many will be in institutional care. The closest     care-givers will be middle-aged people such as children or others, if no partners are     available.      The hypothesis is that critical illness can be a large stressor to care-givers of survivors     in the VIP measured as the occurrence and severity of the usual problems like PTSD and     depression. The investigators hypothesize that a low-threshold on-line support program     decreases the magnitude of anxiety, depression and PTSD for care-givers of very old intensive     care patients (VIP) after discharge.   "
11278|NCT03138265|"     This pilot study aims to investigate whether high intensity interval training can result in     rapid improvements in physical fitness amongst the frail elderly (over 70 years old).     Participants will undergo a wide range of physical fitness measures followed by a four week     exercise protocol. Determination of improvement will be by repeated testing of the physical     measures taken for baseline. The primary outcome measure will be anaerobic threshold. There     will also be a subgroup of participants who will undergo muscle biopsy and D2O ingestion to     allow an insight into the mechanistic basis behind exercise training response in this age     group.   "
11280|NCT03138239|"     Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause     of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying     cause of cirrhosis and HCC in the western world.      The staging of the disease is done by combining blood tests and imaging tests. Ultrasound     scanning, computed tomograph (CT) and magnetic resonance imaging (MRI) scans are methods     based on identifying or significant change in the liver.      Those changes are sometimes difficult to identify, especially when there are changes in liver     structure resulting from disease, such as cirrhosis of the liver.      In many cases it is also difficult to detect secondary scattering in anatomical tests, such     as identifying a disease in normal size lymph nodes or early skeletal dissociation.      Functional imaging is not based on structural changes, but on the ability to detect changes     in the function and properties of the tissue, such as a change in the cell's metabolic     consumption or the presence of proteins that characterize the tumor tissue.PET scans can show     tumor cell activity (the cancer cells are more aggressive, get more sugar and therefore see     more absorption in PET), detect small tumors and metastases outside the liver (because they     do a whole body test). To complete this test, a CT scan is also performed on the same device     (PET-CT scanner).      There is a new material called prostate-specific mRNA that is marked with gallium isotope     (Ga-68-PSMA). It is the substance that is absorbed into the cells of the blood vessels of the     tumor. The Ga-68-PSMA is now widely used in the diagnosis of prostate cancer. The new     researches also found the possibility of using Ga-68-PSMA in primary liver cancer in patients     because of the over-expression of the antigen in the blood vessels.      Therefore, the tests with Ga-68-PSMA and F-18-FDG will complement each other and will give a     complete picture of the extent of the disease.      Each patient has individual characteristics of the tumor, and according to the results it     will be possible to adapt the test to the patient with the appropriate material for the     disease and this will be effective for the decision to treat and follow up.      At the end of the study it will be possible to offer the study participant the appropriate     functional imaging test.   "
11281|NCT03138226|"     Living donor uterus transplantation between identical twins, with IVF before and ET several     months after transplantation. The donor should have completed childbirth.   "
11282|NCT03138213|"     Introduction: Pancreatoduodenectomy is one of the most complex abdominal operations, usually     performed for tumors of the periampullary region and chronic pancreatitis. Minimally invasive     surgery has been progressively developed, first with the advent of hybrid-laparoscopy and     recently with the total-laparoscopy surgeries, but a number of issues are currently being     debated, including the comparisons between three dimension laparoscopic     pancreaticoduodenectomy and the open pancreaticoduodenectomy, the real advantages of three     dimension vision systems, the reproducibility of a total intracorporeal technique and the     oncological results achievable during long-term follow-up after pancreaticoduodenectomy.      Methods/design: This is a prospective, randomized, controlled multicenter trial with two     treatment arms, three dimension laparoscopic pancreaticoduodenectomy versus open     pancreaticoduodenectomy. The trial hypothesis is that three dimension laparoscopic     pancreaticoduodenectomy has advantages in postoperative recoveries and be equivalent in     operation time, oncological results and long-term follow-up compared with open     pancreaticoduodenectomy. The duration of the entire trial is two years including     prearrangement, follow-up and analyses.      Discussion: Despite the fact more and more studies comparing laparoscopic     pancreaticoduodenectomy and open approach. This trial will be the first multi-center RCT     comparing three dimension laparoscopic pancreaticoduodenectomy and open     pancreaticoduodenectomy.   "
11308|NCT03137875|"     Specimen transport from peripheral health structures to the National TB reference laboratory     for MDR-TB identification presents a big challenge in term of sample management, safety,     contamination and delays. Thus a system that allows specimen to be collected and shipped in a     safely manner while reducing the possibilities of contamination, the cost of shipment and     especially the time for detection of MDR-TB by using molecular methods would be very useful.     Whereas the some studies show promising results for the development and standardization of     simple specimen collection and transportation methods for molecular DST, more data is needed     before these can be used in routine.      The study described here aims at identifying a suitable method, in terms of adapted sample     support (s) (slide, filter paper (FTA, Genocard ...)) and DNA extraction method. If one or     several methods are found to give satisfying results, then a larger patient based evaluation     of this (these) method(s) for molecular DST will be performed in a second phase. The protocol     for the second phase will be prepared separately.   "
11283|NCT03138200|"     Transfusion of red blood cells is an everyday practice in critical care with the primary aim     of restoring adequate tissue oxygenation. However, blood transfusion may also be harmful and     costly, therefore a so called restrictive transfusion regime has been suggested by recent     guidelines. These transfusion guidelines consider certain levels of hemoglobin as transfusion     trigger, which on its own gives little information if any about the balance between oxygen     delivery (DO2) and consumption (VO2). Hence, there is a clear need for additional physiologic     transfusion trigger values. One of the potentially useful and easily obtainable physiological     parameters is the central venous oxygen saturation (ScvO2), which has been shown to be a     potential transfusion trigger value in hemodynamically stable but anemic patients. However,     the role of ScvO2 as a transfusion trigger value was examined only in a retrospective     observational study and in animal experiment.      The normal value of ScvO2 in a resting adult at rest is around 70-75%, which is the product     of the VO2 and DO2 relationship. Low ScvO2 usually indicates inadequate DO2. It was found in     an observational study that if ScvO2>70% before transfusion due to transfusion only the value     of hemoglobin increased but the value of ScvO2 did not change. This finding indicates that     the DO2 may have been adequate in spite of the low hemoglobin value and the transfusion may     have been unnecessary. In one of their recent animal experiments, the investigators reported     that in an isovolemic-anemia model the value of ScvO2<70% was only reached when the value of     hemoglobin was far less, 59 g/L, than the recommended lowest value of 70g/L as transfusion     trigger by guidelines.      Despite the pathophysiological rationale and the encouraging results of retrospective studies     and animal experiments, prospective randomized trials in order to test the effects of an     ScvO2-assisted transfusion protocol are yet to be performed.      The aim of this study is to investigate the effects of an ScvO2-assisted transfusion protocol     as compared to the guideline-based, hemoglobin levels guided transfusion practice.   "
11286|NCT03138161|"     This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN     given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary     results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of     Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study,     previously untreated patients will be enrolled.   "
11287|NCT03138148|"     The synchronization between the patient and the ventilator is an essential objective during     mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces     ventilation pressures, improves oxygenation, and decreases sedation. In order to do this, the     inspiratory or expiratory effort of the patient must be detected by the respirator' sensor     systems, so that the assistance delivered by the respirator is coordinated with the patient's     respiratory cycles. The usual systems do not actually detect the beginning of the effort but     its result: variation in flow rate or pressure at the respirator circuit, which depends on     the patient's respiratory mechanics and sensitivity of the sensor. This detection is     currently imperfect, which generates asynchrony between the patient's needs and the     assistance of the respirator. The asynchrony comprises the periods of delay between the     beginning of the inspiration (or expiration) and the response of the respirator, but also of     the unsuitable cycles: inspiratory efforts of the patient not detected by the respirator, or     inversely triggering assistance in the absence of inspiration by the patient     (self-initiation), or delivery of 2 cycles of assistance for a single inspiration (double     triggering).      Asynchrony is a risk factor for prolonged mechanical ventilation in adults. Adult studies     have shown that patient-ventilator asynchrony is common during MV, and is associated with     prolonged MV duration. An association with length of stay in intensive care and in hospital     was also observed. In children, patient-ventilator synchronization is more difficult to     achieve than in adults due to a higher respiratory rate and smaller current volumes. The     impact of patient-ventilator asynchrony on evolution has not been studied in pediatrics.      Patient-ventilator synchronization could be improved by the development of new ventilatory     modes. The new NAVA (neurally adjusted ventilatory assist) ventilation mode detects the     patient's breathing efforts earlier by monitoring the electrical activity of the diaphragm     through the esophagus. This new mode seems to improve synchronization in children. NAVA     ventilation may therefore be a step forward, but its clinical benefits remain to be seen.      The objective of this study is to evaluate the impact of patient-ventilator asynchrony on the     duration of mechanical ventilation in children with acute respiratory failure.   "
11288|NCT03138135|"     Home HIV self-testing has been FDA approved and allows users to read their own HIV test     results at home, while home sexually transmitted infection (STI) test self-collection allows     men to use a swab at home and mail it in for testing. The purpose of this study is to learn     how Men who have Sex with Men (MSM) use these new testing options, a set of online support     tools, and the option to test with someone to support them (a testing buddy).      We will also evaluate whether the online tools help these men to connect with HIV prevention     services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care     services if they test HIV positive.   "
11289|NCT03138122|"     A random sample a random sample of half of all men born in 1943 and living in the city of     Gothenburg, Sweden, have been investigated in 1993 at 50 years of age and will be followed     continuously with repeated re-examinations and follow-up concerning mortality and     cardiovascular diseased. Out of 1463 invited men, 798 (54.5%) accepted the invitation and is     included in this longitudinal cohort study.   "
11290|NCT03138109|"     This retrospective cohort study was intended to analyze the incidence and risk factors of     perioperative severe cardiovascular events in patients with diastolic dysfunction.   "
11291|NCT03138096|"     In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is     one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that     immunization of humans with P. berghei will induce a cross-species immune response without     the risk of a breakthrough infection. To further increase the potential for protective     efficacy, the P. falciparum circumsporozoite (CS)- protein gene has been integrated in the P.     berghei parasite, generating a genetically modified P. berghei parasite, abbreviated as     Pb(PfCS@UIS4).   "
11292|NCT03138083|"     This is a modular, first time in patient, open-label, multicentre study of OMO-1,     administered orally, alone and in combination with anti-cancer treatments, in patients with     locally advanced, unresectable or metastatic solid malignancies.   "
11293|NCT03138070|"     Single centre, single arm, preoperative window of opportunity study with a biomarker endpoint     (expression profiling by RNA sequencing). Patients with resectable, histologically confirmed     head and neck squamous cell carcinoma (HNSCC) for whom surgical treatment is planned as     definitive management will be eligible.   "
11294|NCT03138057|"     This is a prospective, pilot study to explore the relationship between an infant's nutrition,     skin and stool composition at different ages.   "
11295|NCT03138044|"     Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization     (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center     non-randomized trial.   "
11296|NCT03138031|"     Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the     large and unresectable hepatocellular carcinoma: single center non-randomized trial.   "
11309|NCT03137862|"     A PROSPECTIVE, double blind, placebo-controlled trial   "
11297|NCT03138018|"     Because of the lengthening of life expectancy, more and more people are concerned with the     effects of aging on their mental faculties (e.g., memory decline) and with the possibility of     getting Alzheimer's Disease (AD) or other forms of dementia. This increasing awareness of AD     has already resulted in a growing demand for neuropsychological testing. AD's research also     emphasizes the need for early screening to improve the prediction of the disease progression     and the efficacy of any future therapy. Such a drive to screen for pre-dementia raises the     challenging issue of frontline identification of individuals in the preclinical or early     clinical stages of AD. Mild Cognitive Impairment (MCI) is typically considered to be the     prodromal state of AD, and is therefore at the core of the drive for early screening.     Moreover, Pre-MCI so called SCI (Subjective Cognitive Impairment) can precede AD for 15     years. However, many individuals diagnosed with MCI do not convert to AD, some remaining     stable and others even reversing back to normal (with rates of reversion to normal varying     from 4.5% to as high as 53%). This over-diagnosis bias, which has been largely overlooked, is     at the core of the present project at the interface of human and life sciences. Here, we     argue that an important source of overdiagnosis in the prodromal state of AD comes from     negative aging stereotypes (e.g., the culturally shared beliefs that aging inescapably causes     severe cognitive decline and diseases such as AD) that permeate neuropsychological screening.     There is ample evidence in the laboratory that such stereotypes contribute to the differences     observed in the healthy population between younger and older adults in explicit memory tasks.     Additionally, three pilot (lab) studies specifically conducted for the present ANR project     showed that the threat of being judged stereotypically undermines the controlled use of     memory of healthy older adults and simultaneously intensifies their automatic response     tendencies, resulting in impaired memory performance. The present proposal goes several steps     further by examining for the first time whether aging stereotypes are powerful enough to     implicitly permeate the clinical neuropsychological testing and thus inflate memory deficits     in older adults judged at risk (based on either epidemiological criteria or memory     complaints), resulting in false-positive detection of SCI and MCI. This provocative     hypothesis will be tested while 1) using biomarkers of neurodegeneration to distinguish     false-positives from true MCI, and 2) using biomarkers of stress to examine whether and how     aging stereotypes can lead to acute physiological stress during neuropsychological testing.     This innovative project has the potential to offer new recommendations to improve the     diagnosis accuracy of prodromal state of AD, with positive consequences for older people's     wellbeing.   "
11298|NCT03138005|"     The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised,     controlled trial (RCT) to determine whether reducing oxygen administration to target an     oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful     resuscitation from OHCA improves outcome at hospital discharge.   "
11301|NCT03137966|"     Diabetic foot ulcer (DFU) is one of the most invalidating complication of diabetes and     represents a big economic burden for the society. No specific therapy is available for     diabetic foot ulcers.The aim of this study is to define a new approach for treatment of     chronic diabetic wounds. Our concept is based on the improvement of the cellular reaction to     hypoxia. It will address the transcriptional factor HIF-1 (Hypoxia inducible factor-1) which     is the cellular sensor for oxygen and which is specifically repressed by hyperglycemia. The     study will investigate the effect of local deferoxamine (0.66 mg/ml), the only known HIF-1     inducer, on the wound healing rate in patients with neuropathic diabetic foot ulcers. The     primary objective of the study will be the reduction with >50% of the wound area after 12     weeks of treatment.   "
11302|NCT03137953|"     In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test).     There is no objective method of assessment of skin margin. This study is to evaluate the role     of computed tomography/MRI with contrast in assessing the deep surgical margin.   "
11303|NCT03137940|"     The study aims to evaluate the safety and the feasibility of transcranial Direct Current     Stimulation (tDCS) session in children and young adults with Unilateral Cerebral Palsy (UCP).     Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in very short     term, Upper Limb (UL) functions.   "
11304|NCT03137927|"     The study contains three periods: screening, inpatient hospitalization and follow-up. And     should be leaded as a randomized placebo-controlled study with in chain order enrolled     volunteers and dose escalating.   "
11305|NCT03137914|"     This clinical study has as main objective to evaluate if the Nasal Septum Autologous     Chondrocytes Transplantation for Condylar Resorption is safe and effective in the treatment     of degenerative lesions of temporomandibular joint (TMJ). It is a case series, in which 10     participants with diagnosis of condylar reabsorption of TMJ will be selected, with     orthognathic surgery indicated. Orthognathic surgery is conventionally indicated for patients     with condylar resorption to correct dentofacial deformity and, therefore, will not be     performed only in function of this clinical study. The selected participants will be     submitted to nasal cartilage biopsy, for isolation and preparation of the chondrocytes. The     only experimental group to be evaluated will be the group treated with autologous     chondrocytes diluted in hyaluronic acid. The experimental treatment will be performed 15 days     after orthognathic surgery, and will be injected through arthrocentesis. Clinical follow- up     will be performed in the following periods: 7 and 15 days and 1, 3, 6 and 12 months after     treatment. During the consultations, participants will also be evaluated for the intensity     and severity of the pain experienced, as well as the disability related to it, through the     same system used for the diagnostic classification (RDC / TMD). Imaging of the TMJ will be     performed before, 6 and 12 months after the injection of the experimental treatment for bone     and cartilaginous joint tissue analysis. Autologous chondrocyte implantation is expected to     promote the regeneration of TMJ cartilage tissue safely and effectively.   "
11306|NCT03137901|"     This study test the agreement and precision of Pulse Pressure Variation (PPV) and Cardiac     Output (CO) obtained by the Android application Capstesia™ against another pulse contour CO     monitoring ( EV-1000, Edwards Lefesciences, USA)   "
11307|NCT03137888|"     This pilot clinical trial studies the side effects of spectroscopic magnetic resonance     imaging (MRI)-guided radiation therapy and how well it works in treating patients with     newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the     extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high     tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink     tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with     glioblastoma or gliosarcoma.   "
11348|NCT03137355|"     The purpose of this study is to develop a database containing clinical and laboratory     information for patients with Leigh syndrome. The goal is to provide a greater understanding     of Leigh syndrome allowing further characterization of this disease.   "
19201|NCT03034356|"     This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and     cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure     drug, also called an anticonvulsant.   "
11310|NCT03137849|"     Autonomic and endothelial imbalance in post menopause women raise the need to manage     cardiovascular risk. Yoga poses and breathing control present controversial results on     prevention and treatment of hypertension.. The aim of this study is to compare the effect of     12 week intervention based on yoga poses and their muscle contractions known as bandhas     (pelvic floor, core and throat/neck) and ujjayi pranayama (victorious breath) on autonomic     modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function     of hypertensive post-menopausal women.   "
11311|NCT03137836|"     In this trial the investigators aim to verify the potential impacts of a multi-level     intervention with standing desks on behavior and cognitive function in children   "
11312|NCT03137823|"     Diagnosis of Group A beta hemolytic strep tonsillitis -        -  cultre of tonsills (gold standard)        -  culture from bucal surface (test)   "
11313|NCT03137810|"     The aim of this work is to compare the effectiveness of placental cord drainage with no     drainage in reducing the duration and blood loss in 3rd stage of labour.   "
11314|NCT03137797|"     The purpose of this study is to evaluate the short, medium and long-term prognosis for newly     diagnosed HIV patients.   "
11315|NCT03137784|"     The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug     and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients   "
11316|NCT03137771|"     This randomized phase II/III trial studies how well giving maintenance chemotherapy with or     without stereotactic body radiation therapy works in treating patients with stage IV     non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel,     pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation     therapy that sends x-rays directly to the tumor using smaller doses over several days and may     cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body     radiation therapy together may work better than maintenance chemotherapy alone in treating     patients with stage IV non-small cell lung cancer.   "
11318|NCT03137745|"     To study the changes in coagulation profile in patients undergoing cytoreductive surgery and     Hyperthermic intraperitoneal chemotherapy. The objective of the study is to determine the     utility of thromboelastography in comparison to standard coagulation tests in assessing the     coagulopathy in patients undergoing CRS with HIPEC.   "
11319|NCT03137732|"     This is a single centred randomized controlled trial comparing surgeon versus anaesthetist     inserted rectus sheath catheters for management of analgesia post major abdominal surgery.   "
11320|NCT03137719|"     Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This     study aims to determine the current practice and outcomes in these following areas:        1. Community-acquired infections        2. Nosocomial infections        3. Development of second infections        4. Factors predicting ICU care, organ failure, death, and disability        5. Patterns and adequacy of albumin use in infected and non-infected patients        6. Per and post-liver transplant outcomes        7. Quality-assurance and adequacy of management of complications of cirrhosis such as          hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia        8. Regional variations in outcomes and therapeutic strategies   "
11321|NCT03137706|"     This pilot research trial studies characterization of mechanical tissue properties in     patients with pancreatic, liver, or colon cancer. Mechanical properties and stiffness of the     cancerous tissue may be correlated with the standard pathology report that describes the     stage of the disease.   "
11322|NCT03137693|"     This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The     type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose     of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically     focusing on its ability to reduce the chances that additional breast surgery will be needed,     reducing the amount of breast/heart/lung tissue that is irradiated, and to study the     tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer     who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery,     targeting either the whole breast or part of the breast.   "
11323|NCT03137680|"     To investigate the effect of pre-operative exercise on        1. Hemodynamics in the fistula artery and vein, pre and post AV fistula formation        2. Suitability of cannulation of AV fistula at 8weeks   "
11324|NCT03137667|"     A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty     middle and high schools were paired based on several characteristics and randomized within     pairs to receiving a school-based influenza vaccination clinic or not (control).   "
11325|NCT03137654|"     This pilot project addresses two understudied questions related to neurocognitive deficits     observed in treatment-seeking alcoholics. First, whether cognitive training improves     performance and outcomes in alcoholics, and whether men and women differ in their response to     this training. The second is whether directed training using affective materials (e.g.,     emotional faces) is differentially effective compared to that using traditional (i.e.,     neutral) stimuli.   "
11326|NCT03137641|"     CACIES is a descriptive study conducted in two hospital centers in France to assess nurses     internal contamination by antineoplastic drugs.   "
11349|NCT03137342|"     Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a     counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA)     approach that aims to re-engage participants in safe but pleasurable activities in life and     addresses stimulant-abuse as well as associated factors including depression, as barriers to     optimal PrEP adherence.   "
11350|NCT03137329|"     The study aims are        1. to demonstrate the feasibility of recruiting and enrolling 10 subjects aged 55-75          planning to undergo sleeve gastrectomy and enrolling 10-20 (1-2 per surgical patient)          matched subjects to the described intensive lifestyle intervention.        2. to collect preliminary data on the comparative effectiveness of the two interventions on          physical function, weight loss, body composition, bone density and QOL.   "
11327|NCT03137628|"     As a newly developed subject, metabolomics can detect accurately and quantitatively small     molecule metabolites such as proteins, carbohydrates and lipids from plasma, tissue and even     single cell, which aims to analyze systemic dynamic change during physiological and     pathological processes, and thus reveals certain reactions that whole organism responds to     specific stimulation.      Colorectal cancer is one of common gastrointestinal tumors, whose morbidity rate tends to     increase in recent years for modern diet and life style, and colectomy serves as one standard     treatment for it. Under total stimulation of surgical operation, general anesthesia and     mechanical ventilation, a series of stress reactions happen complicatedly to colorectal     patients during anesthesia-ventilation process. Without timely recognition and management of     adverse reactions, side effects like hypoxemia, hemorrhage, inflammation, and even death will     happen intraoperatively or postoperatively.      With different metabolomics methods applied to collect, detect and analyze blood samples,     metabolomics provides an innovatory approach to elucidate systemic response during     anesthesia-colectomy process with multi-factors included. By analyzing and comparing dramatic     alteration of small molecule metabolites in colorectal cancer patients' or healthy controls'     plasma in this project, data can reflect the influence of certain disease (colorectal     cancer), anesthetics and mechanical ventilation on colorectal patients with colectomy, which     is helpful for prevention and treatment of intraoperative and postoperative complications.   "
11328|NCT03137615|"     The purpose of this study is to determine the effects on the heart of injecting local     anaesthetic into the nose prior to surgery on the pituitary gland?   "
11329|NCT03137602|"     Taking part in recommended levels of physical activity in youth with MS may have an important     and positive impact on disease symptoms, long-term disability and health outcomes.     Unfortunately, youth with MS are highly inactive. In order to address this issue, the     investigators have developed an MS-specific mobile application for teens called Active Teens     with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the     feasibility of using the ATOMIC program in youth with MS. The results of this pilot study     will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth     with MS.   "
11370|NCT03137069|"     The purpose this study is to evaluate the efficacy, safety, and pharmacokinetics of GDC-0853     compared with placebo in participants with Chronic Spontaneous Urticaria (CSU) refractory to     anti-histamines.   "
11371|NCT03137056|"     Hemodialysis is the major technique of renal suppleance and membrane improvements allow an     efficient depuration. During the past fifty years, improving the architecture of the     membranes increased constantly the clearance of uremic toxins. Online-hemodiafiltration     allowed a potential interest for decreasing morbi-mortality, but this technique is not     available in all hemodialysis centers yet. Theranova membrane, by its innovating     architecture, could be a valuable option for the enhancement of toxin removal in patients who     are not eligible for online-hemodiafiltration techniques. Interestingly, many works pointed     adsorptive capacities of dialysis membranes and these observations suggest that adsorption     cannot be considered as an epiphenomenon. However, there is a lack of knowledge about the     extent of its benefits in hemodialysis. The efficiency of a session of hemodialysis is     routinely based on the clearance of only few generic toxins (urea, ß2-microglobulin,     myoglobin). The eKT/V formula permitted to link a good depuration of urea with a better     survival. EuTox described in a recent review, a large panel of middle molecules considered as     uremic toxins. As there are many involved toxins, modern evaluation of hemodialysis     efficiency can't be still based on the only description of ß2-microglobulin and urea     removals. Inflammation status is routinely measured with blood levels of CRP. However, its     accumulation is not leading to a toxicity. Many others inflammatory markers have been linked     with morbidity and atherosclerosis, the main cause of mortality in ESRD patients. Obviously,     removal of inflammatory markers by different dialyzers needs to be assess concomitantly but     single conventional dosages are time-consuming.      A minimal albumin loss is considered as another important factor for a safe hemodialysis. Due     to its multiple biological functions, albumin may be one of the most important protein for     the maintenance of body homeostasis. Recent works were interested in the potential toxicity     of some isoforms of the albumin and especially in chronic kidney disease. Modified forms of     albumin have been linked with toxic properties and the removal of modified forms could be     beneficial. Furthermore, albumin oxidation can lead to an under-estimation of albumin levels     with the routinely used assay. A modern evaluation of the capacities of depuration of     dialyzers clearly needs to integrate the evaluation of the clearance and generation of     modified forms of albumin and proteins.      Proteomic techniques allow an interesting non-selective integrative approach. This exhaustive     view would be particularly adequate for building a snapshot of blood uremic toxins,     permeative and adsorptive capacities of each membrane. Due to a high sensitiveness, proteomic     techniques can improve dramatically the characterization of the depuration capacities of     different hemodialysis membranes considering a large range of uremic toxins especially with     middle molecular weight, a large panel of inflammatory markers and modified forms of albumin.     Furthermore, proteomic approach can help to build a quasi-exhaustive description of all the     proteins removed by a membrane.      This project aims to compare the removal capacities of each membrane on a large range of     proteins and forms of albumin (native and modified) with a highly-sensitive LC-MS/MS     proteomic approach. We will also build the complete proteome of depuration of each tested     membrane.   "
11330|NCT03137589|"     Telemedicine allows providing expert know-ledge from specialized health centers to regional     hospitals and practices. In this multicenter, prospective, non-interventional study hospitals     and practices in NRW are supplied via a telematics platform with expertise from the     university hospitals RWTH Aachen and Münster. The communication occurs via highly encrypted     audio/video conference systems and a certified data exchange platform Fallakte+. In total     40.000 outpatient and stationary patients with infectious diseases or need for intensive care     should be treated with telemedical support. The participating hospitals and practices are     randomly distributed into four clusters. The clusters are supplied with telemedicine at     different time points but all clusters start at the same time collecting data from patient     cohorts of infectiology and intensive care (e.g. symptom, therapeutic progress and outcome).     The collected data is later compared to data obtained in the same way from patients treated     with telemedical support and evaluated regarding differences in the quality of treatment,     therapeutic process and the satisfaction of the patients with telemedicine. The aim is to     improve the treatment quality in regional hospitals and practices of patients with serious     and complex diseases and bring forward the application of telemedicine.   "
11331|NCT03137576|"     Aim of this study is to prospectively describe the feasibility of a local nerve blockade, the     Serratus Plan Block (SPB), in the setting of awake (non-intubated), minimally invasive     thoracic wedge resection of the lung (Longitudinal Observational Study).   "
11332|NCT03137563|"     This trial aimed at evaluating the acceptability of HPV self-sampling among french women     eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the     south of France. Acceptability will be evaluated using an anonymous questionnaire and the     main outcome of the study will be the response acceptability  yes  or  no  for HPV     self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the     acceptability of HPV self-sampling.      These data will help to propose new strategies for cervical cancer screening in France,     particularly to taget non-attenting populations   "
11333|NCT03137550|"     Main aim of the COMBAT-CAD-Study is to clarify, if the combination of stress testing with     biomarkers improves the diagnostic accuracy.      Hypothesis of our study is that diagnosis of CAD can be improved by adding biomarkers to     solely stress testing for the workup of patients with suspected CAD or progress of already     known CAD.   "
11334|NCT03137537|"     This study will explore whether ivabradine lowers heart rate, and thus improves exercise     capacity, in survivors of lymphoma who have an elevated resting heart rate as a side effect     of prior radiation treatment.      The drugs involved in this study are:        -  Ivabradine        -  Placebo   "
11335|NCT03137524|"     Chronic Obstructive Pulmonary Disease (COPD) is a common smoking related lung disease. The     main symptom in breathlessness.      Pulmonary Rehabilitation (PR) - a supervised group exercise and education class - is an     effective intervention in COPD to reduce symptoms, improve exercise performance and prevent     exacerbations. However some COPD patients are unable to to effectively exercise as they are     limited by their breathlessness, despite optimal medical management. By reducing their     physical activity to avoid the onset of breathlessness, they become deconditioned and then     further attempts at exercise make them more breathless, leading to an inactivity cycle.      There is a growing evidence base regarding the use of hand hold fan therapy or air therapy to     relieve breathlessness at rest. Limited studies have looked at the use of fan therapy during     exercise, and its role on exercise capacity and recovery time, provisional results which     indicate it may also be useful during activity. Logically you might expect patients who are     less breathless to be able to exercise more, or recover quicker.      This study aims to investigate the effects a hand held fan will have on sensation of     breathlessness and exercise capacity in patients with COPD. This will involve participants     undertaking a standardised field walking test ( 6 minute walk test) with and with out the fan     and then comparing the distance covered and how they felt during and after exercise. This     will better inform how we structure exercise and advice to these patients in the future to     empower patients limited by breathlessness.   "
11351|NCT03137316|"     The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among     patients with diabetic nephropathy.   "
11336|NCT03137511|"     Early detection of melanoma showed an impact on the thickness of the lesions at the time of     diagnosis. One challenge is to improve the modalities.      Decrease the rate of non-compliant patients among patients referred to the dermatologist for     a suspicious lesion (patients who will never go to the consultation), and reduce the time     interval between the first identification of the lesion and the excision allowing the     diagnosis are major issues.      Direct contact between the general practitioner (GP) and the dermatologist would probably     make it possible to shorten the care pathway of patients with lesions justifying excision.      The objective is to evaluate whether contacting the dermatologist directly by telephone and     e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time     required for access to the consultation for the following patients: (a) referred for a     suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of     melanoma so that the dermatologist conclude at the need for excision (true positives).      Expected results: The procedure should shorten the care pathway for patients with melanoma     and decrease the proportion of patients who do not consult the dermatologist when they were     referred (non-observing patients).      This should facilitate the identification of thinner lesions. The benefit for the patient is     then direct with a survival at 5 years higher.      In public health terms, it is expected a benefit as better optimization of resources. In a     situation of shortage of professionals, access to the dermatologist should be optimized by     optimizing emergency access for patients who require it.   "
11337|NCT03137498|"     The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing     patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim     of the study is to compare the safety & efficacy of lidocaine versus ketorolac for acute pain     secondary to renal colic in the Emergency Department (ED).   "
11338|NCT03137485|"     This study is aimed to compare between the results of conventional lumbar discectomy and the     newly used technique in our department; endoscopic lumbar discectomy in neurosurgery     department Assiut university hospitals, so that we can offer our patients the best service in     an updated and minimally invasive way.   "
11339|NCT03137472|"     The aim of the current study is to assess the efficacy of TMS in the treatment of Complex     Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1)     relative to sham treatment (Group 2) once daily for two days will demonstrate a greater     improvement in CRPS-related pain and other associated symptomology (i.e., cognitive,     emotional and physical) compared to baseline. Participants will be followed until they reach     their baseline for two consecutive weeks to assess safety and duration of symptom     alleviation.   "
11340|NCT03137459|"     The purpose of this study is to examine the effect of an individually transtheoretical model     (TTM) tailored intervention on the completion of advance care planning (ACP) behaviors.   "
11341|NCT03137446|"     IV fluid resuscitation has long been recognized to be an important treatment for patients     with severe sepsis and septic shock. While under-resuscitation is known to increase morbidity     and mortality, contemporary data suggests that overly aggressive fluid resuscitation may also     be harmful. Currently, following an initial IVF resuscitation of 30 ml/kg, there is no     standard of care and a lack of evidence to support a fluid restrictive or more liberal     strategy. The investigators seek to determine if a fluid restrictive strategy reduces     morbidity and mortality among patients with severe sepsis and septic shock.   "
11342|NCT03137433|"     This study seeks to examine whether meal-replacement therapy is able to enhance weight loss     among teens with severe obesity. In addition, we are also interested in examining the degree     of weight loss needed to improve important cardiometabolic risk factors among adolescents.   "
11343|NCT03137420|"     Patients who have sustained and survived a polytrauma do heavily depend on the support and     functioning of their family. This is only possible if the family members are physically and     mentally able to cope with the situation.      It is the investigators' hypothesis that the true percentage of polytrauma patients'     relatives suffering under relevant psychological distress is higher than commonly assumed.      The investigators conduct a prospective cohort study where we follow up on a cohort of     patients and their relatives over 1 year after trauma - one group with severely injured     patients (case) and one group with minor musculo-skeletal injuries (control).      In order to assess the influence of the patients' disability and their own psychological     distress on the psychological distress of the relatives, the investigators also collect     corresponding data from the patients themselves.      In order to assess the influence of the trauma itself, the investigators compare a group of     multiple injured patients and their relatives with a group of patients with isolated     musculoskeletal injuries and their relatives. In addition, the investigators record the ISS     of each patient. In order to investigate the changes in relatives' distress over time and to     find out more about potential risk factors or con-founders it is necessary to conduct a     prospective study.   "
11344|NCT03137407|"     The specific aim of the study is to compare the safety and efficacy of a single     administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar     fasciitis.   "
11345|NCT03137394|"     This study will investigate the progression of musculoskeletal (shoulder muscle flexibility,     muscle strength, movement coordination, and rotator cuff health) and psychosocial (fear of     movement, pain catastrophizing) impairments for the first year following SCI, starting with     inpatient rehabilitation, at 6 months, and at 1 year following SCI.      We will use the information obtained from this study information to develop a biopsychosocial     prospective surveillance model, a method for early detection, intervention, and moderation of     shoulder pain. Specifically, we will identify sources of biopsychosocial shoulder pain to     establish effective physical and cognitive-behavioral treatment to prevent loss of function     and independence in individuals with SCI who depend on their arms for activities of daily     living, transfers, and wheelchair propulsion.   "
11346|NCT03137381|"     This study will evaluate the safety and efficacy of CTP-543 in adult patients with chronic,     moderate to severe alopecia areata.   "
11347|NCT03137368|"     This is a multicenter, randomized, open-label, parallel, active-controlled superiority     clinical study conducted in early premenopausal estrogen-receptor positive breast cancer     patients with CYP2D6*10 mutations. The efficacy and safety of Exemestane Tablets combined     with ovarian function suppression/ablation and Tamoxifen Tablets combined with ovarian     function suppression/ablation in the treatment of early premenopausal estrogen-receptor     positive breast cancer patients with CYP2D6*10 mutations are compared.   "
11353|NCT03137290|"     A reversal agent is commonly given to improve neuromuscular function after intra-operative     administration of non-depolarizing neuromuscular blocking agents. The administration of     conventional reversal agent neostigmine is associated with many undesirable side effects. For     almost a decade, a new novel drug sugammadex has been used to specifically antagonize the     effect of aminosteroidal neuromuscular blocking agents.      A total of 80 paediatric patients planned for general anaesthesia were divided into two     groups and were given either neostigmine+atropine, or sugammadex for reversal once the     operation had completed.   "
11354|NCT03137277|"     Adenoma detection rate (ADR) is the most important parameter to measure outcome quality of     (screening) colonoscopy. Since single improvements of imaging have not been able to improve     ADR in many randomized studies, the present study tested the hypothesis that only multiple     imaging improvements such as seen with two generation changes of colonoscopies - i.e.     skipping one colonoscope generation - may be necessary before improvements in ADR can be     measured.      The investigators will test this hypothesis in the present randomized tandem study in 7     private practices in Hamburg and Berlin, in a pure screening colonoscopy setting, aiming at     inclusion of 1200 patients > age of 55 years (screening colonoscopy cut-off in Germany).     Exclusion criteria are symptomatic patients and colonoscopies planned for therapeutic     reasons. Main outcome parameter is the ADR (rate of patients with at least one adenoma/all     patients).   "
11390|NCT03136809|"     Treatment extension study for ALS/MND patients who participated in phase 1 study     CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the     Investigator considers would benefit from continued CuATSM treatment.   "
11400|NCT03136679|"     This study will perform a targeted metabolic analysis in blood and urine samples from     subjects attending the Baylor AT&T Memory Center. The aim is to identify novel biomarkers     that can distinguish normal aging subjects with no cognitive impairment from those with mild,     moderate or severe cognitive impairment associated with Alzheimer's disease. Subjects will     also be screened for B-vitamin deficiencies that may correlate with other metabolic     biomarkers and Alzheimer's disease.   "
11355|NCT03137264|"     The study is being done to determine if non-invasive testing (urine and blood testing) is as     effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M     mutation status. EGFR is a type of protein found on the surface of cells in the body. When     this protein is mutated and becomes too active, it can lead to cancer growth. T790M is a     mutation that develops in response to treatment of the EGFR mutation.      Participating patients will have tumor tissue as well as blood and urine samples, tested for     EGFR T790M mutation status. If the results of one of the three tests show that a patient is     T790M positive, they will be treated according to standard of care, which may include     treatment with osimertinib. Osimertinib is approved for use in the United States for the     treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC).      The study will look at how well patients who are confirmed T790M mutation positive (by urine     and blood testing) respond to treatment compared to patients who are confirmed T790M positive     by tissue testing.   "
11356|NCT03137251|"     This study evaluates the effectiveness of the Transcutaneus Electric Nerve Stimulation (TENS)     during the labour. TENS is a low frequency electrotherapy technique, analgesic type,     generally used in musculoskeletal pathology.      The investigators will have three groups of participants to be administered the TENS, a     different dose in two groups, while the third will correspond to placebo.      The hypothesis of the study is to verify if the TENS is effective as a non-pharmacological     method in the relief of pain during childbirth   "
11357|NCT03137238|"     Parkinson's Disease as well as being a disorder of motor function also causes a wide range of     non-motor disturbances many of which are involved in the prodromal stage prior to the onset     of motor symptoms. Abnormal perception in the visual and in other domains is increasingly     being recognized. Control of the movement of our bodies in space involves perception of     self-motion which is dependent on the processing and integration of multimodality information     from the kinesthetic, proprioceptive, visual (mostly optic flow) and vestibular systems.     Dysfunction in this process may contribute to disturbed postural control and thus result in     gait abnormalities and falls which are common as Parkinson's disease progresses, is difficult     to treat and causes disability and a loss of independence.      The integration of information from different modalities (multisensory integration) is     vital for intact perception of the world. Theoretical studies, based on Bayesian statistics,     have provided a framework to study multisensory-integration with predictions for an 'optimal'     strategy.      Many human and animal studies have demonstrated near optimal cue-integration. Yet, while     multisensory integration is an active topic of research in normal brain function, with     well-established tools, it has not been studied in PD. The investigators hypothesize, based     on the apparent over-dependence in PD on visual cues that PD patients will demonstrate     defective multisensory integration. This can have profound effects on basic motor functions.     Furthermore, based on both visual and vestibular abnormalities (described above) the basic     (uni-sensory) performance may also be degraded in PD.      In this study the investigators will observe the basic (uni-sensory) and the multisensory     integration of visual and vestibular perception of self-motion within the same experiment.   "
11358|NCT03137225|"     The investigator hypothesizes that in very low birth weight infants who require respiratory     support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's     breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or     severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive     pressure ventilation (NIPPV).   "
11359|NCT03137212|"     Patients with acute ST-segment elevation myocardial infarction and thrombolysis indications,     will be given the recombinant human prourokinase for thrombolysis treatment, and in     accordance with the guidelines, will be treated with coronary angiography examination 3 to 24     hours after thrombolysis. The study will explore the best time for interventional therapy     combined with thrombolysis.   "
11360|NCT03137199|"     A Phase 1 investigation will be performed to test the safety of two doses of bonemarrow     derived MSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.   "
11361|NCT03137186|"     This study evaluate the addition of metformin to standard of care in locally advanced and     metastatic prostate cancer, half the patient will receive metformin in combination with     standard treatment, and the other half will receive the standard of care only   "
11362|NCT03137173|"     The purpose of this study is to compare the safety and efficacy of ceftobiprole medocaril     versus vancomycin plus aztreonam in the treatment of patients with acute bacterial skin and     skin structure infections.   "
11363|NCT03137160|"     An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum   "
11364|NCT03137147|"     This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session     cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages     11-17 with co-morbid headache and insomnia.   "
11365|NCT03137134|"     This study will estimate the effect of food and the proton pump inhibitor, esomeprazole on     the pharmacokinetics of crizotinib in a coated microsphere formulation.   "
11366|NCT03137121|"     The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer     patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a     randomized placebo-controlled pilot trial.   "
12622|NCT03120260|"     The purpose of the present study is to evaluate the effect of sleep duration on weight loss     of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The     investigators aim is to compare the effects of short term sleep duration with normal sleep     duration with respect to body weight (and abdominal adiposity).   "
11367|NCT03137108|"     Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been     developed. It was suggested, that this method could be used to improve the therapy process     after a spinal cord injury (SCI). The aim of this study is to investigate the immediate     effects of tSCS with different stimulation modalities on voluntary motor control in patients     with incomplete SCI.   "
11368|NCT03137095|"     Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and     age-matched control participants. The investigator is trying to better understand the     prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to     the general population as well as what biological mechanisms may play a role in the     development of these difficulties. Patients will be asked to complete five assessments over     the course of approximately 5 months. Assessments 1,3 and 5 include computerized and paper     and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the     collection of a blood sample.   "
11369|NCT03137082|"     Guanfacine may preferentially reduce craving and improve cognitive control in women with     Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the     objectives of this study are to conduct a 10-week out-patient clinical trial to examine the     effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in     women with AUD.   "
11372|NCT03137043|"     Asthma is a chronic disease. Prevalence of asthma in 2014 among Spanish population was 5%, of     which 10% were diagnosed with severe asthma. According to Spanish National Guideline for the     Management of Asthma (GEMA) 4.1 criteria, asthma can be classified according to its severity     (intermittent, mild persistent, moderate persistent or severe persistent) or level of asthma     control (controlled, partly controlled or uncontrolled). This Guideline describes that only 1     in 10 subjects with severe asthma is well controlled, meaning that there is a 90% prevalence     of non-controlled severe asthma.      This prospective, non-interventional, observational, multicenter and case-control study aims     to assess the prevalence of severe asthma in Spanish Hospitals. The study will describe the     characteristics of severe versus non-severe asthmatic subjects, assess their eligibility to     receive biological treatments approved for this disease, resource consumption and evaluate     the most prevalent phenotypes of severe asthma in Spain. Enrolled subjects will be divided     into two cohorts, based on asthma severity according to the Global Initiative for Asthma     (GINA) and the International European Respiratory Society (ERS)/American Thoracic Society     (ATS) Guidelines. Cohort A: subjects diagnosed of severe asthma and Cohort B: subjects with     non-severe asthma. Approximately 320 severe asthmatic subjects and 160 non-severe asthmatic     subjects will be enrolled in the study. A software of big data will be used to do a sub study     for comparing the results obtained through this software tool against results obtained     through Gold standard classical methods used in this prospective observational study (the     descriptive assessment of severe asthma prevalence and the prospective evolution of     subjects).   "
11373|NCT03137030|"     This clinical trial is being conducted to compare concentrations of hydrocodone and     acetaminophen in the blood after administration of different amounts of tablets of a new and     a marketed tablet formulation in healthy adults.      Part 1 is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral     dose Phase I trial in 32 healthy male and female subjects. Part will consist of an Enrollment     Visit, 4 treatment periods (each lasting approximately 90 hours), and a Final Examination.     The treatment periods will be separated by a washout period each lasting at least 7 days.      Part 2 is optional and depending on pharmacokinetic data review after Part 1. It is a     randomized, single-site, open-label, 2-treatment, 2-period crossover, single oral dose part     in healthy male and female subjects. Part 2 will consist of an Enrollment Visit, 2 treatment     periods (each lasting approximately 90 hours) and a Final Examination. The treatment periods     will be separated by a washout period lasting at least 7 days.      Participants must fast for approximately 10 hours prior to administration of Investigational     medicinal product (IMP) and until approximately 4 hours after the administration of the IMP.   "
11374|NCT03137017|"     This clinical trial is being conducted to compare concentrations of hydrocodone and     acetaminophen in the blood after administration of a new and a marketed tablet formulation     under fasted and fed conditions in healthy adults.      This is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral     dose Phase I trial in 32 healthy male and female subjects.      The trial will consist of an Enrollment Visit, 4 treatment periods (each lasting     approximately 60 hours) separated by 3 washout periods (each lasting at least 7 days), and a     Final Examination.   "
11375|NCT03137004|"     A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as     second-line treatment in patients with AGC.   "
11376|NCT03136991|"     This is a Phase I study to investigate the safety and tolerability of AZD4831 in healthy male     participants, conducted at a single center. The results from this study will form the basis     for decisions on future studies. Another purpose of this dose escalation study is to find out     the right dose of the experimental drug to be given to study participants in future studies.     Even though there were no harmful effects seen in the animals tested, investigator does not     know what side effects the experimental drug might cause in humans. However, site personnel     managing the study participants will be blinded to the extent possible and as long as     possible to minimize any impact on data collection. Study participants will be blinded to     treatment allocation.      The study will be conducted in healthy participants to avoid interference from disease     processes or other drugs.      The participants will stay at the study center during the whole dosing period and until 48     hours post final dose.   "
11386|NCT03136861|"     The purpose of the study is to evaluate the efficacy and safety of secukinumab 150 mg     compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease     activity, fatigue and predictability of disease flares in patients with axial     spondyloarthritis who have an inadequate response to prior non-steroidal anti-inflammatory     drugs. This study will also assess the efficacy and safety of secukinumab 300 mg compared to     secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional     benefits of dose escalation in patients with axial spondyloarthritis.   "
11377|NCT03136978|"     Accumulating evidence suggests that the peritoneal microenvironment of women affected by     endometriosis undergoes a number of local inflammatory-reparative phenomena, with the     involvement of resident macrophages, and the attraction and recruitment of peripheral     mononuclear cells (monocytes and lymphocytes) from the blood into the peritoneal cavity:     during endometriosis a breakdown occurs in endometrial and peritoneal homeostasis caused by     cytokine-addressed cell proliferation and dysregulation of apoptosis.      The surrounding microenvironment may address the macrophage plasticity towards a transient     and reversible polarization. These polarized phenotypes reflects the proinflammatory or     anti-inflammatory status and may change over the time. They could be functionally classified     in two main populations: classically activated macrophages (M1) and alternatively     activated macrophages (M2).      Considering that published data so far are still not robust enough to drawn firm conclusion,     the aim of this research project will be to evaluate M1 and M2 macrophages in endometriotic     tissue from women affected by endometriosis at different stages.   "
11378|NCT03136965|"     The overall goal of this research is to find an effective treatment for patellar tendinopathy     (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to     investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function     scores) and bio-mechanical (knee strength) measures will be correlated with disease     modification changes assessed using conventional and novel quantitative magnetic resonance     imaging (MRI) and ultrasound (US) techniques.   "
37487|NCT02794948|"     The purpose of this research is providing valuable traditional chinese medicine theory and     formula in treating Primary Ovarian insufficiency.   "
11379|NCT03136952|"     Children who undergo surgery routinely for surgery that risk high levels of circulatory     changes (eg heart surgery) is currently used routinely monitoring as regional oxygenation     technology of the brain (NIRS). Near infrared spectroscopy (NIRS) is a technique for     measuring regional oxygen saturation, indirect autoregulation of brain. We know that reduced     oxygenation of the brain can occur with severe immediate blood loss. We in the research group     has been able to note that in children who undergo surgery for cranioplasty interventions <1     year old, when they have ongoing excessive bleeding, decreases oxygenation in the brain and     sometimes sharply before we can replace the loss of blood, even the blood pressure can be     adequately maintained. Perioperative hypovolemia is a risk factor upset autoregulation of     brain. Respect of which the mean arterial pressure (MAP) required to maintain intact     autoregulation during general anesthesia still lacks a scientific consensus.      By illuminating the skin and underlying tissue with infrared light in the spectra of 700 to     1100nm, it is possible to measure regional oxygen saturation in various tissues. At cerebral     measuring sensor is placed frontally, just below the hairline. INVOS then returns the     absolute values of cerebral oxygen saturation frontally in the area where the sensor is     placed.      A frontal placement may in some cases be impractical / impossible and thus limits the ability     to monitor the brains of children with different types of surgery or body positions. At     certain cranioplastic intervention surgery a frontal placement is not always possible, partly     because of surgical technic reasons, but also that the child may have to lie prone during     surgery. An alternative placement of INVOS sensor could mean greater opportunities to monitor     cerebral oxygen saturation and thus increase patient safety within the mentioned categories     of patients. An occipital location is practically possible in many cases. The purpose of this     study is to investigate whether a occipital located sensor can measure cerebral oxygen     saturation in a reliable manner.   "
11380|NCT03136939|"     10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were     enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We     implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which     secreted by IGRP-specific T cell. Results were compared between these groups.   "
11381|NCT03136926|"     Adequate antifungal therapy is a critical determinant of survival in patients admitted to an     Intensive Care Unit (ICU) with suspected or proven fungal infections. Critical illness can     alter the way human body handles antifungal agents, i.e. how the drugs are distributed in the     body and removed from the body. Consequently, these changes can increase the risk of     inappropriate antifungal exposure that may lead to adverse consequence on patients' outcome.     Developing an evidence-based antifungal dosing guideline is of global significance and should     be considered a priority to improving clinical outcomes for patients receiving antifungal     agents      The aim of the SAFE-ICU Study is to develop optimised antibiotic dosing guidelines for ICU     patients with life-threatening infections that account for patient characteristics. This will     be achieved through completion of the following aims:      i) Describe detailed demographic, clinical and plasma antibiotic concentration-time data in a     large ICU patient cohort; ii) Perform a robust statistical analysis of the data collected in     Aim 1 to develop an enhanced preliminary prediction algorithm for antifungal dosing.      This is a multi-national study and will enrol ICU patients who are prescribed an antifungal     agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin,     micafungin or amphotericin B). A minimum of 12 patients per drug will be enrolled across at     least 15 countries and up to 80 ICUs.      Eligible patients are those admitted to the ICU, who are prescribed an antifungal agent     (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin,     micafungin or amphotericin B). Blood samples will be taken to measure drug concentration.     Sampling will occur on two occasions, first during study days 1-3 and then a second time     between days 4-7, each over an 8-24 hour period. Blood samples will be taken from a vascular     access device already inserted for ICU patient care. Abdominal samples from abdominal     indwelling drains already inserted peri operatively will also be collected on these two     occasions in the subgroup of patients with intra-abdominal infection. Data on infection,     various blood tests and patient specific data will be collected using a structured case     report form (CRF). Patients will also be followed up 30 days after enrolment into the study     to evaluate 30-day mortality.      Collected samples will be frozen and stored locally and then shipped in large batches for     processing at Burns Trauma and Critical Care Research Centre, The University of Queensland,     Australia. Data analysis for development of antifungal dosing algorithms will also be     undertaken at The University of Queensland, Australia.   "
11382|NCT03136913|"     This study is being conducted to compare the outcomes of two separate surgical techniques     used in tooth extraction and ridge preservation. Ridge preservation is done to potentially     minimize the amount of bone loss that occurs between the tooth extraction and implant or     bridge placement, as compared to leaving the extraction site empty. There are two techniques     that are commonly used for these procedures, either to close the surgical site of the     extracted tooth with sutures (closed flap technique) or to leave the extraction site open to     heal naturally (open flap technique). In the open flap technique there will be sutures used     to secure and hold down the material used to cover the wound, called a non-resorbable     membrane. The flaps will remain in their natural position, the site will fill up naturally     with new tissue from the bottom up and then close itself in from the sides. The investigators     want to see which technique offers better healing and reduces bone loss.   "
11383|NCT03136900|"     An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.      After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The     caloric intake is not the only important nutritional variable in PICU. The protein intake     objective is around 1,5g/kg/d in order to reduce muscular catabolism.      The aim of this study is to compare the impact of an isocaloric enteral diet, either     fortified by milk concentration (in order to increase the protein intake) or by a supplement     of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart     disease.   "
11384|NCT03136887|"     This study was designed to demonstrate the safety and performance of the JOURNEY II XR total     knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All     participants will be implanted with the JOURNEY II XR total knee system.   "
11396|NCT03136731|"     Main aim: To find evidence-based screening strategies for celiac disease in high risk groups     and to find new biomarkers or biomarker combinations for celiac disease diagnostics and     follow-up.   "
11387|NCT03136848|"     Kidney transplantation is the treatment of choice for end-stage kidney failure, but access to     transplantation is limited by a severe shortage of donor organs. Although the use of kidneys     from higher risk deceased donors has increased the availability of organs, these grafts are     associated with a greater risk of delayed function, inferior performance, and shorter     survival than standard criteria donor kidneys. The current standard of care for kidney graft     preservation prior to transplantation is static cold storage. Preliminary results from large     animal kidney transplantation studies and a human clinical trial suggest that normothermic     machine perfusion of kidneys prior to transplantation may ameliorate the injury sustained by     kidney grafts during cold static preservation, allow assessment of organ viability prior to     transplantation, and reduce the risk of delayed graft function or non-function. Such a     strategy may not only improve the performance of kidneys that are currently considered     acceptable for transplantation, but may also facilitate the assessment and utilization of     kidneys that are currently not considered for transplantation. This study will examine the     feasibility and safety of normothermic ex vivo perfusion of human kidneys prior to     transplantation. The study will evaluate kidney function after transplantation using standard     clinical parameters. Study participants will be followed for 3 months following     transplantation and their outcomes recorded. Feasibility will be measured using the ratio of     actual:eligible kidney grafts preserved by normothermic ex vivo perfusion and will also take     into account logistical issues with respect to implementation and ease of use of the ex vivo     perfusion device. Safety will be assessed by rates of device failure resulting in organ     discard, primary graft non-function, delayed graft function, graft failure, and recipient     mortality.   "
11388|NCT03136835|"     A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation     in the setting of fetal congenital heart disease   "
11389|NCT03136822|"     (DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was     developed by Ege University School of Pharmacy Department of Pharmaceutical Technology. This     dressing has been categorised as Class III medical device. This clinical study will be     conducted in patients with diabetic foot ulcers.   "
11391|NCT03136796|"     GCX damage and its relationship to pharmacodynamics and pharmacokinetics of beta lactam     antibiotics in critically ill Hypothesis to be tested: GCX damage impairs pharmacodynamics     and pharmacokinetics of beta-lactam antibiotics in critically ill patients. There is     correlation between GCX damage and insufficient beta lactam levels in patients with commonly     used dosing. The aim of the study: Evaluation of relationship between GCX damage and     pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill. Type of     the study: Observational. Subjects: Adult patients admitted to ICU with beta-lactam     antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture     results). Sample size calculation: 20 patients (expected correlation coefficient 0,6, alpha     error = 0,05) will lead to power study = 0,89. Intervention: none. Data to be recorded and     analyzed: Demographics, type of patients (trauma, post surgical, medical, after cardiac     arrest), severity score - Apache II, SOFA, fluid balance, a presence of delirium, clinical     outcome, sublingual microcirculation by SDF imaging will be recorded three times during     antibiotic treatment at the time points for blood samples required for pharmacodynamics and     pharmacokinetic analysis, microcirculatory data and Perfused Boundary Region.   "
11392|NCT03136783|"     The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF     of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1)     is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is     retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib     or dabrafenib + trametinib).      Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of     sometimes severe side effects is not predictable. There are currently no predictive     biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of     the intrinsic sensitivity of the cells of patients to different combinations of targeted     therapy molecules would make it possible to propose the best therapeutic combinations. The     cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.      The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant     cultures and human skin equivalents.   "
11393|NCT03136770|"     A study to assess the pharmacokinetics and safety of CK-30 600 mg (Compound K) and red     ginseng extracts 2.94 g after a single oral dose in healthy male volunteers   "
11394|NCT03136757|"     Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem     cell transplantation (HSC), and is responsible for significant early mortality despite     prophylactic strategies developed in recent decades, Especially since it is resistant to     first-line treatment.      The present diagnosis is difficult, non-specific and is based on the combination of an     evocative clinical context (CSH allograft, time to appearance before J100, characteristic     clinical manifestations), suggestive anatomo-pathological analysis (predominantly     inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the     exclusion of any differential diagnosis (in particular serology / negative viral PCR).      However, to date there is no molecular characterization of this manifestation, and therefore     no specific treatment.      The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous     expression of a group of genes (up to 800 on the same sample), from a very small amount of     RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and     included in paraffin. It allows the detection of a molecular signature of the tissue     analyzed.      No transcriptomic analysis has ever been performed on human tissues with GVHD.   "
11395|NCT03136744|"     Activity recommendations for the general population and those with multiple sclerosis (MS)     focus on the promotion of activity that has a moderate intensity - in other words, activity     intense enough to breathe heavily and sweat. Most adults do not achieve the recommended 150     minutes of moderate-intensity activity per week. Even fewer persons with MS meet the     recommendations. Those with MS often have problems with walking and fatigue, thus it is not     difficult to understand that moderate intensity activity is challenging. Our study will test     the feasibility of a new approach focusing on activity over the whole day - promoting light     activity such as standing or walking around the house while reducing prolonged sitting     (sedentary behaviour). This approach is supported by research evidence showing that too much     sedentary time, especially prolonged bouts of sitting, is associated with health risk factors     such as obesity and cholesterol level. Recent work with persons with MS confirms that     prolonged sitting is a problem for this population and emphasises the potential importance of     this approach.      This study tests the feasibility of an internet-based intervention designed to decrease     sedentary behaviour and to increase upright time in people with MS.   "
27868|NCT02920957|"     The aim of this study is to determine the clinical performance of comfilcon A in comparison     to senofilcon C.   "
11397|NCT03136718|"     This study will establish the feasibility of a theoretically-driven, personalised educational     intervention delivered through mobile technologies in first-time hearing aid users. Namely,     the C2Hear (https://www.youtube.com/C2HearOnline) multimedia videos, or Reusable Learning     Objects (RLOs) (Ferguson et al., 2015; 2016), will be repurposed into short 'bite-sized'     mobile-enabled RLOs (mRLOs).The development of the intervention will be based on a recently     developed comprehensive model of health behaviour change (COM-B) (Michie et al., 2014). The     intervention will be tailored to individuals' needs, and incorporate greater user     interactivity and self-evaluation.   "
11398|NCT03136705|"     STUDY SUMMARY Title: EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHORUS     HOMEOSTASIS Protocol Number:STU00090161 Phase: Phase 1, detailed physiologic study     Methodology: double blind, randomized, placebo-controlled, 2x2 factorial Study Duration:     12-18 months (to complete the entire study protocol) Study Center: Single-center Objectives:     Define short-term effects of the interventions (lanthanum carbonate and nicotinamide) on     indices of phosphate handling Number of Subjects: 80 Diagnosis and Main Inclusion Criteria:     Healthy volunteers Study Product(s), Dose,Route, Regimen: Nicotinamide, 750 mg by mouth twice     daily, Lanthanum carbonate, Fosrenol, 1000 mg by mouth three times daily with meals Duration     of administration: 2 weeks (length of time study participants are enrolled in study)     Reference therapy: reference is a placebo Statistical Methodology: Repeated measures analysis     using mixed linear models   "
11399|NCT03136692|"     The study team analyzed de-identified user data provided by the commercial app Lose It!, an     entity of FitNow, Inc.   "
38190|NCT02785770|"     This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy     adult subjects. This is conducted as part of standard drug development.   "
11402|NCT03136653|"     The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics     (PK), immunogenicity and biological activity of MP0250 in combination with bortezomib +     dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM).      MP0250 is a multi-DARPin with three specificities, able to simultaneously neutralize the     activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF)     and also to bind to human serum albumin (HSA) to give an increased plasma half-life and     potentially enhanced tumor penetration.   "
11403|NCT03136640|"     This is a safety, feasibility and pharmacokinetic study to confirm that the recommended safe     dose and schedule of ModraDoc006/r (oral docetaxel with ritonavir) as determined in a     previous phase I study is also safe and feasible in the target population of patients with     CRPC.   "
11404|NCT03136627|"     This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and     preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with     metastatic renal cell cancer. This will use a standard '3+3' dose-escalation trial design. A     cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a     DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6     subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6     subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will     be considered the MTD. This is a validated trial design for Phase 1 trials.      Following completion of the dose-escalation cohorts and determination of MTD, an expansion     cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability,     and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same     target population.   "
11406|NCT03136601|"     The overall objective of this study is to compare the efficacy of the standard monthly     maintenance therapy for percutaneous tibial nerve stimulation (PTNS), to sessions as the     patient needs (prn) between 2 weeks and 12 weeks, based on overactive bladder symptoms. This     is study is to help determine feasibility for conducting a larger trial that is appropriately     powered to provide meaningful data.   "
11407|NCT03136588|"     Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the     risk of medical intervention due to acute rejection and graft loss but burdens the     socioeconomic system in the form of increased healthcare cost. Aggressive preemptive effort     by healthcare professionals geared to ensure adherence to immunosuppressants in KTRs is     significant and imperative.      This study was designed as a prospective, randomized, controlled, and multicenter study aimed     at evaluating efficacy and stability of the information and communication technology     (ICT)-based centralized monitoring system in boosting medication adherence in KTRs.      This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE,     Korea) under Industrial Technology Innovation Program ( No. 10059066, 'Establishment of ICT     Clinical Trial System and Foundation for Industrialization').   "
11408|NCT03136575|"     This study aimed to observe how a six week qigong program influence patients with head and     neck cancer during active radiotherapy treatment course. The quality of life, sleep     dysfunction or depression and shoulder and neck function will be accessed by questionnaire,     and ANS function will be objectively investigated using heart rate variability measurement.   "
11418|NCT03136445|"     The purpose of this study is to test whether giving tranexamic acid to patients receiving     treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet     transfusions. Patients will be randomised to receive tranexamic acid (given intravenously     through a drip, or orally) or a placebo.   "
11439|NCT03136172|"     To investigate biomarker reflects systemic or specific organ perfusion well, we are going to     the observational comparison study using several hemodynamic monitoring methods in the     premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with     perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.   "
11409|NCT03136562|"     The primary purpose of this study is to determine the prevalence of adrenal insufficiency in     a population of patients with kidney transplants receiving low dose prednisone treatment.      Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to     glucocorticoid treatment. The study includes a control group of patients with kidney failure     currently treated in dialysis, who are not in glucocorticoid treatment.      Individual genotyping is performed to determine the haplotype of glucocorticoid receptor     polymorphisms: N363 S, BclI, ER23/23EK and 9β in all the patients with the purpose of     investigating this as a risk factor for the development of adrenal insufficiency. The     hypothesis is that subjects with one or another of the polymorphisms in the glucocorticoid     receptor gene will either have increased or diminished glucocorticoid sensitivity.      Using validated questionnaires assessing the quality of life and functional level of the     patients enrolled in the study we aim to establish a link between functional level and     biochemically proven adrenal insufficiency.      Other secondary outcomes in the study includes bloodpressure, body composition, bone density,     metabolic syndrome, inflammation and salivary cortisol profiles.   "
11410|NCT03136549|"     Epistaxis or post-pharyngeal bleeding is the most common complication after nasotracheal     intubation (NTI). Prior thermal softening of the endotracheal tube (ET) has been recommended     as one of the methods to prevent nasal trauma from nasotracheal intubation. However, thermal     softening of tubes tends to adversely affect the nasotracheal navigation of the ET.      During NTI under conventional direct laryngoscopy, the tip of the Macintosh laryngoscope is     advanced into the vallecula, indirectly elevating the epiglottis by applying pressure on the     hyoepiglottic ligament. Although this maneuver allows optimal visualization of the glottis,     it lifts the larynx away from the tip of the advancing nasotracheal tube (NTT), which     generally lies along the posterior pharyngeal wall. Most clinicians use Magill forceps to     direct the tip of the NTT anteriorly to enter the glottis. Magill forceps may cause damage to     the cuff of an ET or may injure oropharyngeal mucosa.      The use of a video laryngoscope and a cuff inflation technique has been proposed as a method     for reducing the malalignment of tubes. Indirect laryngoscopy using a Video laryngoscopy can     reduce malalignment by minimizing lifting the glottis during laryngoscopy. The cuff inflation     technique (wherein the cuff of ET tube is inflated with 15 mL of air) has been used while     performing blind NTI to guide such malaligned polyvinyl chloride (PVC) ET tubes into the     laryngeal inlet. Recently, one study reported that the cuff inflation technique consistently     improved the oropharyngeal insertion of the different ET tubes of varying stiffness during     direct laryngoscope-guided NTI.      However, there has never been study about effect of cuff inflation technique on navigability     when performing NTI under video laryngoscopy guidance with ET tubes of varying stiffness.     Investigators thus conducted this study to assess the role of a cuff inflation technique in     improving oropharyngeal navigation of NTT, while performing video-laryngoscope-guided NTI.     Simultaneously, investigators also assessed and compared the nasotracheal navigability and     incidence of nasal injury with two technique during cuff inflation-supplemented NTI guided by     video- laryngoscopy   "
12269|NCT03125174|"     Analysis of mucus, mucin and DNA concentration, MUC5B/5AC ratio, rheology, osmotic pressure,     cohesion and nucleotides in sputum on 30 individual samples of good quality in healthy     individuals and those with bronchiectasis. (60 total)   "
11411|NCT03136536|"     The purpose of this study is to investigate the mortality and frequency of organ dysfunction     in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers     of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal     tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro     University Hospital, Örebro, Sweden, are asked for participation in this study. All     participating patients sign informed consent at the inclusion. During the operation and     during the postoperative intensive care, the function of the spinal cord, the     gastrointestinal tract and the kidneys are collected along with other clinical parameters.     Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each     patient during the operation and during the postoperative care at the intensive care unit.     During the operation two microdialysis catheters are placed in the abdomen, and the samples     are continuously collected and analyzed. The biomaterial samples are stored in a biobank for     later determination of proteins and other molecules. Postoperative survival and the frequency     of complications are analysed.   "
11412|NCT03136523|"     Construction of a large cohort of lung cancer patients to evaluate the Prognostic and     Predictive Significance of the molecular biomarkers Epidermal growth factor receptor (EGFR),     KRAS, Anaplastic lymphoma kinase (EML4-ALK), Programmed Death-Ligand 1 (PD-L1) protein and     Microsatellite Instability (MSI) in lung cancer: A tissue microarray-based study of 500     cases.   "
11413|NCT03136510|"     Apixaban is a potent, oral, selective reversible direct inhibitor of factor Xa with a     favorable efficacy and safety profile in the prevention of non valvular (NV) atrial     fibrillation (AF). It has been shown, including by our group, that D-dimers levels (molecular     marker of coagulation activity) are predictive of the events (including mortality) in patient     with AF independently of the antithrombotic treatment. The aim of the study is to evaluate     the changes in plasma levels of biomarkers of coagulation activation: D-dimers, prothrombin     fragments F1+2, von Willebrand factor (vWF) and thrombin-antithrombin complexes (TAT) in     response to apixaban treatment in patients with NVAF.   "
11414|NCT03136497|"     A Study of Venetoclax Plus Ibrutinib and Rituximab in Patients with Relapsed/Refractory     Diffuse Large B-cell Lymphoma (DLBCL).      Our hypothesis is that the combination therapy of BTK (Bruton's tyrosine kinase) Inhibitor     Ibrutinib plus Venetoclax and Rituximab in relapsed or refractory DLBCL will have an     increased activity with acceptable toxicity. Furthermore, this new novel therapeutic     combination will be safe and well tolerated among this patient population.   "
11416|NCT03136471|"     Investigators propose to use a natural experiment design to examine the impacts of the new     CPT code (99490) for chronic care management on health outcomes. The Investigators will     collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve     more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of     the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health     Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across     all phases of this natural experiment. This project will examine outcome differences created     by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM     framework to identify the critical elements of the programs that will enhance the reach,     effectiveness, adoption, implementation, and maintenance of these strategies in the diverse     LaCDRN diabetes populations.   "
11417|NCT03136458|"     This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced     nephropathy. All of the patients will receive endovenous normal saline to prevent     nephropathy, half of the patients will receive remote ischemic preconditioning while the     other half will not.   "
11475|NCT03135704|"     The objective of this study is to assess the effectiveness of the Re Spine mattress, which     was designed as an alternative to physiotherapy in the treatment of low back pain (LBP).   "
11419|NCT03136432|"     Cerebral Palsy (CP) is a group of permanent disorders of movement and posture, generally     accompanied by secondary musculoskeletal problems. Studies in literature showed taht children     with CP supports a link between the levels of impairment and walking ability. The 6 Minute     walk test is a standardized, self-placed walking test commonly used to access functional     ability in children with cerebral palsy. While decreased exercise capacity has been     identified in children with cerebral palsy, the clinical determinants of the 6MWT in this     population have not been investigated yet. Thus the aim of this study is to investigate the     relationship between 6 Minute walk test, quality of life, respiratory muscle     strength,activities of daily living using with Pediatric Evaluation of Disability Inventory     and trunk control.   "
11420|NCT03136419|"     Microbiota and innate immunity in pouchitis: predisposing factors and modulation of the     inflammation with probiotics.      Around 20-25% of ulcerative colitis patients undergo restorative proctocolectomy with ileal     pouch anal anastomosis. Pouchitis is an idiopathic inflammatory disease that may occur in     ileal pouches. In our recent studies, we showed altered microbiota and innate immunity     relationships in pouchitis. We plain to perform a double-blind, placebo-controlled trial     probiotic therapy vs placebo starting at the time of ileostomy closure to evaluate the impact     of microbiota that colonizes the pouch mucosa in the pathogenesis of pouchits, to determine     how expression and activation status of the innate immunity system in different cell types     and anatomical districts of pouch mucosa relate to microbiota population and follow-up the     clinical outcome of anal pouches in light of microbiota-innate immune system interplay.      Our study will include three phases:        1. analysis of the intestinal microbiota with High Throughput Sequencing Unit and anaerobes          cultures        2. characterization of innate immunity with TLR, NLR, nicotinic receptors and LPMC analysis        3. assessment of microbiota and innate immune system in the ileal pouch before ileostomy          closure, 2 months after ileostomy closure and after 1 year follow up.   "
11421|NCT03136406|"     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination     therapy in subjects with pancreatic cancer who have progressed on or after previous Standard     of Care first line therapy and chemotherapy.   "
11481|NCT03135626|"     This randomized clinical trial was conducted to examine and compare the effectiveness of     pulpotomy in primary molars treated with calcium silicate based materials including     Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA     and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116     primary molars in 29 children were treated by pulpotomy and followed for a period of 24     months.   "
11422|NCT03136393|"     High neonatal mortality rates accounts for a substantial early loss of lives in Malawi; and     has thus been a hindrance for Malawi to eradicate child deaths. From 2000 to 2011, Malawi     achieved an overall reduction of 23% in under-five child mortality. The reduction was more     substantial between the second and the fifth year of life, being 28%. However, in the     neonatal period the reduction was half, at 14%. Neonatal deaths in developing countries are     due to prematurity or low birth weight, neonatal infections, birth trauma related conditions     and congenital anomalies.      Being of low birth weight increases the risk of death four fold in the neonatal period. Even     when low birth weight infants survive, their poorly developed immune function exposes them to     increased morbidity in early life. Maternal nutrition represents by far the greatest     influence among pregnancy environmental on birth weight in low income countries. There is     strong evidence that health and dietary counselling is effective in improving child nutrition     outcomes. Thus we propose to test the effectiveness in improving birth weight by a low cost     intervention, community based health and nutrition counselling delivered to mothers during     pregnancy in Malawi.      On the other hand, in the Malawian context offering individualized dietetic counselling could     be impeded by the healthcare workforce short fall. Currently the health workforce does not     include dieticians . The use of lay health workers (LHW) has been identified as one of the     effective strategies to meet the health workforce shortage challenges in low resource     settings.      It is on this basis that a study was planned, aimed at developing lay health worker delivered     community based nutrition counselling to mothers during pregnancy and measuring its     effectiveness in improving birth weight in the Malawian context. The study was comprised of     an initial i) formative study, followed by ii) a cross-sectional survey. Findings of these     two sub-studies were utilized to develop a nutrition counselling intervention. Finally iii) a     cluster Randomized Controlled Trial (cRCT) aimed at measuring the effect of the intervention     on birth size (weight, length, arm and abdominal circumferences) will now be conducted which     is being elaborated in this protocol.   "
11423|NCT03136380|"     Danirixin is a selective chemokine receptor antagonist being developed as a potential     anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD).     The aim of the study is to assess the safety, tolerability and pharmacokinetics (PK) in     healthy Japanese subjects over the age of 65 years (inclusive). The study will be conducted     in two parts: Part 1 will be a double blind, placebo-controlled, 3-period crossover,     ascending single oral dose administration of GSK1325756H (Hydrobromide Salt Tablet     Formulations of Danirixin) 10, 50 and 100 milligram (mg) in the fed condition. Part 2 will be     an open label, 2-period crossover, single oral dose of GSK1325756H 50 mg in fed and fasted     state. This study will provide an understanding of PK of hydrobromide salt of GSK1325756 in     population of healthy elderly subjects and also contribute to the selection of appropriate     dosing for Phase IIa study in Japan.   "
11424|NCT03136367|"     What Matters Most is a study that aims to determine how best to help women of lower     socioeconomic status make high-quality decisions about early stage breast cancer treatments.     What Matters Most will be comparing two decision aids used in the clinic visit to usual care     (what normally happens in the clinic). The first decision aid (Option Grid) presents     evidence-based information about lumpectomy and mastectomy in a tabular format using text     only. The second decision aid (Picture Option Grid) presents evidence-based information about     lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most     aims to show that the interventions can reduce disparities in decision-making and treatment     choice between women of high and low SES.   "
11425|NCT03136354|"     The investigators compared the perioperative, oncological, functional and immunological     outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for     treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain     induced, endoscopic submucosal dissection is expected to be less invasive when compared to     laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show     that endoscopic submucosal dissection is associated with a significantly better perioperative     recovery and less immunological disturbance. Moreover, it will also induce a better long term     outcomes as the stomach can be preserved, hence the digestive function is maintained to     prevent long term functional morbidities of the gastrointestinal tract.      This study will be the unique first study in the literature to show that intramucosal early     gastric cancer can be adequately treated by endoscopic submucosal dissection with better     perioperative, functional and quality of life outcomes when compared to laparoscopic assisted     gastrectomy.   "
11426|NCT03136341|"     Task-dependent upper limb tremor is a disorder that frequently impairs patients' function and     quality of life. Few studies exist that quantify the improvements in motor performance and     disability with botulinum toxin (injections). The study team aims to perform an exploratory     pilot trial using toxin Type A (Dysport) in 25 patients with task-dependent upper limb     tremor, to refine quantitative measures of performance using blinded video analysis,     demonstrate efficacy and tolerability of injections, and provide power calculations for a     potential future multi-centered double blinded clinical trial.   "
11427|NCT03136328|"     About 40 patients with histologically and/or clinically confirmed and/or suspected NET are     anticipated to be enrolled during 3 years from initiating the study.      Patients will be recruited at Montefiore Medical Park where there is a medical group     specialized in the diagnosis and treatment of NETs. Each patient will undergo a screening     visit within 14 days prior to receiving study medication.      The primary goal of the analysis is to estimate the diagnostic accuracy of 68Ga-DOTATOC PETCT     for detecting NET compared to conventional imaging techniques.   "
11428|NCT03136315|"     During ultra endurance events, athletes experience extreme physical and mental demands,     sometimes at the limits of the adaptive response to human physiology. This is particularly     true for the renal function, and some evidence for acute renal failure has already been     shown, sometimes leading to dialysis. However, the precise mechanisms involved in acute renal     failure in such ultra endurance races are not clearly elucidated.      The aim of our study is to estimate glomerular filtration rate from serum and urinary     creatinine and cystitin C at the beginning and at the end of a 110 km ultra endurance race.     Our hypothesis is that during the ultra endurance race, renal function may be injured, with a     risk for the athlete.   "
11429|NCT03136302|"     The goal is to establish another anatomical referencing system in order to achieve an even     higher accuracy when implanting stimulation electrodes.   "
11430|NCT03136289|"     The aim of this study was to examine the association between family consumer behaviors     (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes.   "
11431|NCT03136276|"     When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur.     So, material with higher mechanical properties is required. Celtra Duo is a new material with     glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance     of the material.   "
11482|NCT03135613|"     The aim of this study is to investigate kinematics of knees of patients with tumor around     knee after microwave ablation with plate internal fixation   "
11432|NCT03136263|"     This is a randomized, double-blind, placebo-controlled crossover study of single-dose     intranasal oxytocin (24 IU) in 18-55 year-old men with attention deficit/hyperactivity     disorder (ADHD). Following a screening visit to determine eligibility, subjects will return     for two main study visits. During the main study visits, study participants will receive     either oxytocin (Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) or placebo     (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy), followed by assessments     of cognitive control over attention and behavior. Twenty-four participants will be randomized     1:1 to one of two drug orders, i.e., oxytocin - placebo or placebo - oxytocin. In an     additional neuroimaging substudy, a subset of participants will undergo task-based and     resting-state functional magnetic resonance imaging (fMRI) following oxytocin/placebo     administration to investigate the effects of oxytocin on fMRI activation and functional     connectivity within the cognitive control network.   "
11433|NCT03136250|"     Neck pain is among the most common musculoskeletal disorders worldwide and is an important     public health issue in terms of personal wellbeing. Prevalence of neck pain show excessive     variations, with a point prevalence varying between 6% and 22%, and one year prevalence     ranging between 1.5-75%. Neck pain like all other mechanical disorders leads to pain,     disability and decreased range of motion (ROM). Stretching is a very common exercise     performed by sportsmen, elderly, in physical therapy and rehabilitation patients, thus     practiced in all sorts of fitness programs. The major types of stretching included in the     literature are static, dynamic and pre-contraction stretching; of which static stretching is     the conventional type of stretching. The different types of pre-contraction stretching     include Proprioceptive Neuromuscular Facilitation (PNF) stretching, Post Isometric Relaxation     (PIR), Post Facilitation stretch (PFS) and Active Isolated Stretch (AIS). Pre-contraction     stretching is also considered a part of Muscle Energy Technique (MET). Recently MET and     pre-contraction stretching have been shown to have significant superiority over conventional     stretching in management of mechanical neck pain, but the evidence is currently lacking     regarding which of the two pre-contraction stretching protocols, namely autogenic and     reciprocal inhibition is more effective than the other. A RCT will be conducted in order to     find and compare the effectiveness of conventional stretching and pre-contraction stretching     (autogenic inhibition and reciprocal inhibition). One Control group (conventional group) and     two Experimental groups (Experimental Group A - Autogenic Inhibition & Experimental Group B -     Reciprocal Inhibition) will be formed. The participants will be recruited in the study if     they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital     and randomized into the three respective groups. All the groups will receive the gold     standard treatment for chronic neck pain including mobilization and modalities. In addition     to the gold standard treatment the participants will receive specific stretching protocol     based on their interventional group   "
11434|NCT03136237|"     This is an open-label, three part study to evaluate the effect of BCX7353 on drug     transporters as well as the effect of an inhibitor of drug transport on BCX7353.   "
11435|NCT03136224|"     Since circumcision is a significant workload for surgeons working at the rural state     hospitals in Turkey, the use of circumcision techniques that are easy to implement and have     low complications is becoming widespread. In this study, thermocautery, plastic clamping, and     conventional (open surgical) circumcision techniques were compared to each other in terms of     their short and long term complications.   "
11436|NCT03136211|"     This study examines the effectiveness and the costs of a complex multiple risk behavior     intervention to promote healthy behaviors in people aged between 45 and 75 years attended in     Primary Health Care services. This intervention aims to reduce tobacco use, to enhance     adherence to the Mediterranean dietary pattern and to increase physical activity. The study     also seeks to provide evidence on the strategies to integrate health promotion into the usual     clinical practice of primary care providers.   "
11437|NCT03136198|"     Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially     treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27%     of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies     have all failed. The evidence for existing AHF therapies are poor: No currently used AHF     treatment is known to improve outcomes. ED treatment is largely the same today as 40 years     ago. Congestion, such as difficulty breathing, weight gain, and leg swelling, is the primary     reason why patients present to the hospital for AHF. Treating congestion is the cornerstone     of AHF management. Yet half of all AHF patients leave the hospital inadequately decongested.     The investigators propose a novel approach to aggressively decongest patients in the ED     setting: lung ultrasound guided, protocol driven, AHF management. LUS B-lines are a measure     of extra-vascular lung water (EVLW). In the setting of AHF, LUS B-lines are a measure of     congestion. This simple, easily learned technique has excellent reliability and     reproducibility. The investigators hypothesize that a strategy-of-care will outperform usual     care. At the present time, usual care is largely empirical. This study will improve the     evidence base for ED AHF management. This proposed pilot study, if successful, will lead to     an outcome trial examining whether an ED AHF strategy-of-care increases days alive and out of     the hospital for patients.   "
11440|NCT03136159|"     Post-cesarean section wound infections are responsible for longer hospital stays,     readmissions, and ultimately, increased costs to the healthcare system. Silver-containing     dressings may prevent wound infections. The purpose of the current study is to determine if     the use of a silver-impregnated dressing decreases the occurence of wound infection following     cesarean delivery.   "
11441|NCT03136146|"     This clinical research study has 2 parts: lead-in and Part 2.      The goal of the safety lead-in portion of this study is to find the highest tolerable dose of     the combination of clofarabine, etoposide, cyclophosphamide, liposomal vincristine,     dexamethasone, and bortezomib in patients with relapsed/refractory acute lymphoblastic     leukemia (ALL) and lymphoblastic lymphoma (LL).      The goal of Part 2 of this clinical research study is to learn if this drug combination can     help to control the disease. This will also be studied in the safety lead-in.      The safety of this drug combination will be studied in both parts of the study.   "
11442|NCT03136133|"     To investigate the effect of marine peptide combined with dietary protein on the capacity to     recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose     homeostasis.   "
11454|NCT03135977|"     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)     has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the     2-year survival is extremely low. There is no standard maintenance treatment recommendation     for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line     treatment for advanced gastric cancer. Several phase III clinical studies of non small cell     lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less     toxic side effects and better patient tolerance. However, the clinical application of     apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical     trial is designed to investigate the efficacy and safety of apatinib combine with etoposide     as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.   "
11443|NCT03136120|"     Interstitial lung disease (ILD) often affects distal lung, and the evaluation of drug     distribution to the relevant lung compartments is essential for development of new treatment     options. This single center study will utilize samples obtained by transbronchial cryobiopsy     (TBCB) procedure to assess the distribution of inhaled drugs in the lungs of the subjects     with fibrotic lung disease using mass spectrometry techniques. The study will have a single     visit and will include approximately 20 adult subjects with suspected fibrotic ILD and     requiring TBCB as part of their diagnostic assessment. This will provide TBCB samples from up     to 20 subjects, up to 5 of whom may also provide endobronchial forceps biopsy samples. The     study will have 3 phases including screening to check the eligibility, biopsy phase in which     all subjects will receive nebulized ipratropium bromide 500 microgram (mcg) for 10 minutes     immediately before undergoing bronchoscopy and follow up phase from 7 to 14 days after the     procedure. Drug distribution in the lung will be assessed by analyzing biopsy samples     collected using mass spectrometry and imaging techniques.   "
11444|NCT03136107|"     The purpose of this study is to determine the SPF of the test product according to the     International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of     the SPF).   "
11445|NCT03136094|"     This study compares the effectiveness of a program to detect and manage suicide risk among     American-Indian and Alaska Native (AI/AN) youth. Half of the participants will receive caring     text messages to reduce suicidal thoughts, attempts, and hospitalizations and to increase     engagement, social connectedness, and resilience in at-risk youth. The other half will     receive usual care that does not include the caring text messages.   "
11446|NCT03136081|"     Septic shock is associated with acquired immunoparalysis which is associated with a high risk     of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of     mortality but is difficult to diagnose. The use of colonization indexes and risk factors on     the other hand expose to unnecessary use of antifungals. The aim of the present study is to     evaluate whether the host response to infection associated with candida biomarkers would help     to anticipate the candidiasis onset.   "
11447|NCT03136068|"     This is a research study to measure the effect of digoxin injection on Dilation and     Evacuation (D&E) procedure duration. Digoxin is the most commonly used feticidal agent among     family planning subspecialists, and is commonly used for a variety of reasons including     provider preference, patient preference, and concerns over legal status of later D&E     procedures. There have been several studies on digoxin administration, adverse effects, and     impact on the D&E procedure, but doctors want to clarify how digoxin effects D&E procedure     time, if at all.   "
11448|NCT03136055|"     This is a pilot study of pembrolizumab-based therapy in previously treated extrapulmonary     poorly differentiated neuroendocrine carcinoma   "
11450|NCT03136029|"     Heart disease is the leading cause of death in the United States, accounting for one in every     four deaths in 2010 and costing over $300 billion annually in health care, medication, and     lost productivity. Heart failure with a reduced ejection fraction (HFrEF), a clinical     syndrome that develops as a consequence of heart disease, now affects almost 6 million     Americans. Within the VA Health Care System, HFrEF hospital admission rates continue to rise,     and remain the number one reason for discharge from VA hospitals nationwide. Unfortunately,     over one-third of all Veterans suffering from HFrEF die within two years of discharge despite     optimized drug therapy, an unacceptably high number. This proposal is focused on how impaired     muscle blood flow contributes to exercise intolerance in HFrEF, and on subsequently     developing strategies for restoring exercise tolerance and slowing disease progression in     this patient group. It is anticipated that knowledge gained from these studies will     contribute to improved standard of care, quality of life, and prognosis in this VA patient     group.   "
11451|NCT03136016|"     The present study is a randomized school-based trial of a sample of 5th and 6th grade     students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of     Rio de Janeiro, Brazil. The aim is to investigate whether adding nudging actions to the     intervention group of PAAPPAS trial (PAAPAS Study, NCT02711488) increase fruits, vegetables     and water consumption and daily energy expenditure, in a factorial design.   "
11452|NCT03136003|"     Individuals with mild hemophilia A (MHA) bleed infrequently but can in the setting of trauma     which often is when participating in sports/exercise. Although both exercise and DDAVP     (desmopressin) can raise Factor 8/Von Willebrand Factor (FVIII/VWF levels), it is not clear     whether the pathophysiological mechanism is the same. Consequently it is not known if DDAVP     and exercise would have additive effects in raising FVIII:C and VWF levels or if one would     one negate the effect of the other. The aim of this 2 center (Sickkids and Columbus, Ohio),     prospective, cross-over design study is to compare the impact of exercise vs. DDAVP on     hemostasis in patients with MHA and also to investigate the impact of sequentially     administering these interventions on their hemostatic indices.   "
11476|NCT03135691|"     Lung protective ventilation (LPV) has been proposed to reduce the incidence of postoperative     pulmonary complications (PPCs), and protect against ventilator induced lung injury (VILI).   "
11453|NCT03135990|"     Anxiety disorders are the most common mental health diagnosis in the US and are associated     with avoidance that causes functional impairments and decreases quality of life. Social     anxiety disorder is among the most prevalent anxiety disorders, with most common age of onset     being in adolescence. The frontline treatment for social anxiety disorder is cognitive     behavioral therapy with exposure. However, a significant number of adolescent patients do not     get better after completing cognitive behavioral therapy or experience relapse. This could be     explained by findings in both mice and humans suggesting that cue-based extinction learning     occurs less readily in adolescents than in children and adults. Studies using mouse-models     have overcome this age disparity by enhancing contextual cues when fear extinction learning     takes place. Providing realistic learning contexts for exposure could be the key to enhancing     treatment effects in adolescents. This is often challenging for a variety of reasons,     including difficulty realistically mimicking anxiety-provoking social situations due to     limited resources, clinician training, time, or motivation. Virtual reality environments     could provide contextual exposures for social anxiety.      This pilot study will test the feasibility of integrating virtual reality technology in     exposure-based treatment in youth ages 13-23 diagnosed with social anxiety disorder with the     goal of approximating equivalent efficacy with traditional cognitive behavioral therapy, and     assessing feasibility of virtual reality technology with this population. We will also pilot     a fear conditioning and extinction learning paradigm to explore the relationship between     extinction learning and efficacy of virtual reality exposure therapy, using physiological     assessment indicators to mark changes in fear response. These markers will also be used prior     to the initiation of the therapy to assess the degree to which virtual reality environments     invoke a true fear response, comparing the 12 participants with social phobia to 12 age     matched, non-anxious control participants. The aims of this study are threefold: to assess     feasibility of using virtual reality in treatment of social anxiety in youth, to examine     whether virtual reality invokes arousal similar to anxiety and test the physiological     assessment protocol, and to evaluate whether exposure using virtual reality environments     reduces symptoms of social anxiety and related functional impairment.   "
11455|NCT03135964|"     Introduction Negative pressure wound therapy (NPWT), also known as topical negative pressure,     has become a popular therapy for the treatment of many acute and chronic wounds. In many     randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and pressure     ulcer. However, most studies used commercial VAC device in combined with polyurethane (PU)     foam. It is not yet clear where NPWT combined with gauze as wound filler is as effective as     the PU foam. This RCT evaluated the efficacy of the gauze and PU foam, two kinds of fillers     routinely used in negative pressure wound therapy, on the healing of the diabetic     lower-extremity ulcers and the pressure ulcer.      Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer     or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups     randomly. The letter of consent was signed by the patient or patient's family. After     debridement of the infective wound, the wound of experimental group was packed with a     moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A     noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then sealed     with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest drainage     system and to standard wall suction at 125 mmHg negative pressure. The dressing was changed     at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control group, the     PU foam dressing from KCI was packed and sealed to the wound with the same continuous wall     suction at -125mmHg. Investigators observed and recorded the ulcer area twice a week on each     time of changing dressing in the following 3 weeks. The percentage of wound area     reduction(PWAR) was used as a predictor of wound healing. The repeated measuring data were     analyzed using linear mixed mode with SPSS statistical software. This clinical study was     approved and monitored by Institutional Review Board of Show Chwan Memorial Hospital.   "
11456|NCT03135951|"     The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of     SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide     (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days     following drug administration.   "
11457|NCT03135938|"     Purpose: To determine the surgical outcomes of the grading versus classic Inferior Oblique     Anterior Transposition (IOAT) technique in treatment of patients with asymmetric dissociated     vertical deviation (DVD) and inferior oblique overaction (IOOA).      Methods: In this randomized clinical trial, a total of 38 patients with IOOA of >+1 and a     minimum DVD difference of 5pd between their two eyes will be included. Comprehensive     ophthalmic examinations including visual acuity assessment, measurements of noncyclo- and     cycloplegic refraction as well as ocular deviation, biomicroscopic and funduscopic evaluation     will be performed at baseline and repeated three months after the surgery. The function of     extra ocular muscles will be evaluated by duction and version movements denoting from -4     (underaction) to +4 (overaction) grades. Also, IOOA will be graded as +1 to +4 according to     the covering of the cornea under the superior eyelid during the ocular movement towards     supra-nasal direction. The difference of DVD≥5pd between two eyes will be considered as     asymmetric DVD. All patients will be randomized in the two groups to undergo IOAT surgical     procedure; in the classic group, IO muscle will be sutured to the sclera at the level of     inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD     between the two eyes; while in the grading group, IO muscle of the eye with more severe DVD     will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of     DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference     between the two eyes.   "
11458|NCT03135925|"     The investigators propose to determine whether it is acceptable to patients with a diagnosis     of multiple myeloma (a type of blood cancer that can cause bone weakness, pain and fatigue)     to be offered and attend an exercise group before receiving an autologous stem cell     transplantation (being given back one's own stem cells, following receipt of intensive     chemotherapy, to enable bone marrow to start producing blood cells again). Exercise has been     shown to be effective in reducing many of the side effects of myeloma and the treatment     patients receive to manage the disease. Prehabilitation i.e. providing an intervention after     diagnosis but before treatment begins has been effective in reducing the severity of side     effects of treatment in cancer patients receiving surgery. No evidence exists for its use in     patients with myeloma. Patients awaiting transplantation will be provided with information     regarding the study and invited to join. Patients who agree to take part will attend the     hospital for an assessment of their exercise capability and to complete one set of four     questionnaires. They will receive an exercise booklet, advice and complete one attempt at     their exercise programme under supervision of a physiotherapist. Patients will be requested     to attend the gym for a minimum of six further weeks to complete their exercise programme.     Patients will complete a repeat set of questionnaires and a repeat walking test six weeks     after the first, on admission to hospital for their transplant and on the day they leave     hospital. Some patients will be invited to discuss their opinions of the exercise programme     and how useful they felt it was to them in preparing for their transplant. If the study shows     that the exercise programme is acceptable to patients and we can recruit enough patients to     test it in a larger trial, the investigators will apply for further funding.   "
12623|NCT03120247|"     Oral trans-mucosal administration is relatively easy and convenient, it also reduces first     pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam     premedication.   "
11459|NCT03135912|"     This is a three-arm randomized controlled trial to assess the efficacy of an experimental     treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will     be tested against a vehicle control to determine efficacy and safety, and against an active     comparator to evaluate the success of the treatment relative to an existing gold-standard     treatment. Patients will be treated for four weeks, with their condition being assessed at     the end of treatment and two weeks after the end of treatment. The primary endpoint for this     study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and     minimal clinical signs & symptoms. Secondary endpoints include safety and patient evaluation     of treatment.   "
11460|NCT03135899|"     The primary objective of this study is to investigate safety and tolerability of three     consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651     administered via oral inhalation in male and female mild asthmatic subjects after a bolus     methacholine challenge.   "
11469|NCT03135782|"     This pilot clinical trial studies how well provider training works in increasing patient     tobacco cessation counseling and referrals for patients with cancer undergoing radiation     therapy. Health care provider training in motivational interviewing techniques and utilizing     tobacco cessation resources may help doctors understand how health care providers can     effectively increase their confidence in talking to patients about tobacco cessation     counseling.   "
11480|NCT03135639|"     **Follow-up Control Study for Creativity Study      Purpose: To investigate the effect of transcranial alternating current stimulation (tACS), a     form of noninvasive brain stimulation, in healthy subjects. This experiment is a follow-up to     previous tACS studies that used a creativity assessment.      Participants: 35 males and females, at least 18 years of age, without history of major     psychiatric/neurological disease or associated medication use, or prior brain     surgery/implants.      Procedures (methods): This is a cross-over study design. Participants will undergo a control     condition of stimulation (sham or individual alpha, 8-12 Hz, tACS) during     electroencephalogram recordings. In addition, pupil diameter, heart rate, and respiration     will be measured continuously. This is to study the physiological effects of stimulation.   "
11461|NCT03135886|"     This study will test two active evidence-based practice coaching (PC) interventions to     improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site     1) HIV testing and linkage to care and 2) joint HIV/Hepatitis C virus (HCV) testing and     linkage to care among patients seeking/receiving substance use disorder treatment.      Aims are:      Aim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of     HIV testing in OTPs including the incremental impact of the HIV/HCV intervention on HIV     testing.      Aim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation     and sustained provision of HIV testing and timely linkage to care.      Aim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of     the PC interventions compared incrementally to one another and to the control condition.      Primary Hypothesis:        1. The two PC interventions will result in significantly higher rates of HIV testing than          the information control condition in the first period after intervention (initial          uptake--Primary) and after 12 months of follow-up after initial uptake (sustained          implementation--Secondary).        2. The HIV/HCV testing PC intervention will have a significantly higher rate of HIV testing          in the first period after intervention and after 12 months of follow-up compared with          the HIV testing only PC intervention (Secondary).   "
11462|NCT03135873|"     NAFLD/NASH is one of the most common complications of obesity and diabetes mellitus in     Western populations affecting approximately 50% of diabetics and 76% of obese patients. Due     to the lack of specialized treatment, many new efforts focus on exploring alternative,     non-pharmacologic means for managing the disease, including bioactive substances in fruits,     vegetables and plants or their products. Mastiha, a natural product of Greece, consists of a     great variety of bioactive phytochemical compounds and demonstrates antioxidant,     antiinflammatory, antimicrobial and lipid lowering properties. Taking into account the     contribution of oxidative stress and inflammation to NAFLD/NASH pathogenesis, the hypothesis     that Mastiha could improve disease aspects is investigated. Thus, design of a multicenter (4     centers across Europe), randomized, double-blind, placebo controlled (parallel arm) clinical     trial to assess the effect of Mastiha on clinical course of NAFLD/NASH patients has been     conducted. The effectiveness of the proposed intervention will be evaluated via clinical and     laboratory markers. MAST4HEALTH aims also at exploring gene-diet interactions and at     correlating genetic and epigenetic markers with metabolomic and intestinal microbiota     profiles pre- and post- intervention. To this end, patients with confirmed NAFLD/NASH will be     allocated to either verum or placebo group. Duration of the intervention will be 6 months and     the dosage applied will be 2.1 g daily. NAFLD/NASH diagnosis will be confirmed by MS scanning     and the sensitive LiverMultiScan technique. Anthropometric, demographic data, body     composition, dietary habits, physical activity, family history and smoking status will be     assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation,     as well as epigenetic and metabolomic profiles will be assessed in blood samples, while the     metagenome profile will be examined in stools. Both groups will receive counselling to allow     for body weight regulation up to 5%. Compliance will be assessed monthly and side effects     will be reported.   "
11463|NCT03135860|"     The objective of this exploratory study is to examine the utility of high resolution computed     tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function     of long term iNO administrationusing the device INOpulse for 4 weeks in relation to Patient     Reported Outcome (PRO) and exercise tolerance in subjects with WHO Group 3 PH associated with     COPD on LTOT.      Changes from baseline to 4 weeks of pulsed iNO and after 2 weeks of withdrawal from pulsed     iNO will be evaluated.   "
11464|NCT03135847|"     To assess the functional characteristics and utility of upper and lower limb prosthetic     devices (advanced bionic and current clinical standard-of-care) that incorporate     physiologically relevant touch and/or movement feedback.   "
11465|NCT03135834|"     This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a     0-,6- month schedule. This trial is also studyng safety and immunogenicity of a meningococcal     pentavalent vaccine.   "
11466|NCT03135821|"     Irritable bowel syndrome (IBS) is a prevalent condition that adversely affects patient's     quality of life and represents a large health care burden globally. Currently, there is no     satisfactory treatment for IBS and Chinese Herbal medicine (CHM) has been suggested to be     potentially useful. However, the efficacy of CHM in the treatment of IBS is unclear and its     mechanism of action is unknown. To date, attempts to characterize CHM efficacy universally     suffer from poor scientific method or they do not faithfully replicate authentic CHM best     practice. The overall goal of this proposal is hence to address these deficiencies by     combining the best of CHM with western medicine.The investigators propose a 10-week     randomized, double-blind, placebo-controlled study on 104 patients that form the intersect     between western medicine and CHM. The participants would fulfill ROME III criteria for     IBS-Constipation predominant subtype, which is also the TCM (Traditional Chinese Medicine)     syndrome of Liver Qi stagnation. The investigators will test a core herbal formula specific     for treatment of Liver Qi stagnation against placebo that consist of only 10% active     ingredients but which is indistinguishable by taste from active treatment. Efficacy will be     assessed by comparing symptoms reported at baseline (2-week run-in period) to end of     treatment (8 weeks) and an optional follow up period (12 weeks). The primary end point will     be improvement in IBS-Symptom Severity Score. Mechanism of action will be explored by     measuring changes to the stool microbiome and GI transit times. If successful, this trial     would provide one of the first evidence- and mechanism-based approach to translate CHM into     mainstream IBS management.   "
11590|NCT03134196|"     This is a multi-center, randomized, double-masked, placebo-controlled clinical trial of     suppressive valacyclovir for one year in immunocompetent study participants with an episode     of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis     due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment.   "
11467|NCT03135808|"     Treatment of rectal cancer has improved to the extent that its local recurrence rates are now     much lower than other sites in the large bowel. It has been found that higher rates of     recurrence in the sigmoid section of the colon, just before the rectum. This might be due to     a narrowing in the bowel, and difficulties identifying whether cancers are in the sigmoid or     rectum. The aim is to investigate the bowel from 20 patients undergoing surgery for left     sided colorectal cancer at the Royal Marsden. These patients would have routine     investigations and treatments, but once the bowel has been removed, it would undergo a MRI     scan and additional slices and photography during pathological analysis.   "
11468|NCT03135795|"     To explore the epigenetic mechanism of postoperative analgesia and side effect induced by     μ-opioid Receptor Agonists presented with sufentanil among general population.   "
11479|NCT03135652|"     This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative     radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy     combined with surgical resection or radiofrequency ablation of liver lesions.   "
11470|NCT03135769|"     Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated     hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a     complete hydatidiform mole. GTN patients are commonly treated with single agent treatment     (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according     to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients     with resistance to these treatments are treated with another single agent drug or     polychemotherapy regimens.      Chemotherapy standard regimens are old and toxic for these young lady patients, with     potential long term effects detrimental for further maternity and quality of life. There is a     need for modern targeted agents with better benefit/toxicity profiles.      There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in     chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune     tolerance is hijacked by GTN cell for proliferating :        -  Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of          immune system for rejecting GTN cells.        -  Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes          and settings of GTN tumors from French reference gestational trophoblastic center.        -  The case of complete and durable response to pembrolizumab was reported in a patient          with multi chemo-resistant GTN.   "
11471|NCT03135756|"     Eligible participants will come in for three separate visits in which they will be     interviewed, perform a variety of tasks, and undergo a non-invasive MRI scan. The     investigators anticipate that (1) participants with anxiety and depression will likely     perform differently than the healthy controls on cognitive tasks, (2) participants with     anxiety and depression will likely show differences in brain functionality compared to the     healthy controls, and (3) depression and anxiety likely share some underlying mechanisms.   "
11472|NCT03135743|"     Cancer is the leading cause of death in man and the second leading cause in women with 85,000     and 63,000 deaths, respectively, in 2012. A working group led by Holly L. Howe, PhD, in 2002     defined primary neoplasia Such as the occurrence and diagnosis of two or more independent     neoplasms of different histology in the same patient. The occurrence of a new cancer has     become more frequent in recent years: the prevalence of multiple primary neoplasia (NPM) is     estimated between 0.73% and 11.7%. According to the French data, the risk of second cancer in     people who have already had a first cancer is increased by 36% compared to the general     population. Several studies have reported an increase in the risk of cancer after treatment     of lymphoma but there are currently no studies on the occurrence of lymphoma and cancer of     synchronous occurrence.      In our department, 19 patients presented cancer and lymphoma synchronously, that is to say 6     months between 2007 and 2012.      The main objective is to show that there is an increase in the incidence of cancers in     patients diagnosed for lymphoma synchronously. Secondary objectives are to describe the     clinical and biological characteristics of the patients concerned and to formulate hypotheses     on the physiopathological mechanisms involved: peri-tumoral B-cell lymphoproliferation,     alteration of the immune system or rearrangement of the BCR.      In a second step, the investigator could propose a multicenter epidemiological study using     data from the different Cancer Registries. If results are confirmed in a larger cohort,     recommendations could be made.   "
11473|NCT03135730|"     The Center for Autonomic Medicine in Pediatrics (CAMP) has collaborated with doctors from     around the world to build the first International ROHHAD (Rapid-onset Obesity with     Hypothalamic Dysfunction, Hypoventilation and Autonomic Dysregulation) REDCap (Research     Electronic Data Capture) Registry. This registry is an international collaboration with     ROHHAD patients and their physicians recruited from around the world.      The purpose of this IRB-approved research study is to gain a better understanding of the     various health problems ROHHAD patients face with advancing age, and how these relate to each     patient's specific medical course. With a better understanding of specific ROHHAD and     associated clinical manifestations, we will be able to better anticipate healthcare needs and     to provide more accurate guidelines to healthcare providers world-wide in caring for patients     with ROHHAD.      The study aims to obtain detailed phenotypic information (information about health and     well-being) on patients with ROHHAD. Participation would require filling out a confidential     survey that asks questions regarding health and past medical history. Involvement in the     project is completely voluntary and there is no compensation for taking part. However, this     project will help us learn more about this devastating disease, with the goal of advancing     treatment.   "
11474|NCT03135717|"     Protein energy wasting is an independent factor associated with morbi-mortality in chronic     kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney     disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients     diagnosed with chronic kidney disease according to the degree of evolution of the disease and     the diagnostic method.      Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney     disease. Nutritional treatment differs depending on the stage of the kidney disease acute or     chronic treated whether or not by dialysis. Nutritional monitoring should be regular,     individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding     techniques should allow all the nutritional needs. Their indications depend on the clinic,     biochemical assessment and nutrient intake.   "
11477|NCT03135678|"     The purpose of the OBSERVE PILOT is to verify the feasibility of collecting individual health     data which is obtained through blood samples, continuous monitoring devices, medical imaging,     a questionnaire, and a blood pressure monitor.      Feasibility of collecting individual health data within the OBSERVE PILOT is described as the     ease of gathering a broad variety of data by assessing: (1) the willingness of the subjects     to participate in the study, (2) the logistics corresponding with the variety, and (3) the     regulatory aspects of gathering a broad variety of data.   "
11478|NCT03135665|"     In the scoliosis screening program of the Student Health Service (SHS), Department of Health     (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray     examination basing on the screening protocol did not have Cobb angle greater than the     referral threshold of 20°; ie they did not need specialist referral and thus were subjected     to unnecessary x-ray exposure. Our primary objective is to determine whether a new     radiation-free ultrasound system could identify subjects with Cobb angle greater than the     referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The     secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the     accuracy of ultrasound assessment.   "
11485|NCT03135574|"     Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of     consultation in ophthalmology.      It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and     therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the     oculomotor tract is the first-line examination required. In the usual clinical practice, the     investigators noticed in several patients unusual areas of high-intensity signal within the     oculomotor nerve on T2 sequence, observed in various locations along the nerve path     (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the     investigators, has never been reported in the literature and could confirm the nerve     impairment.      In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this     new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate     differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis     (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be     systematically included in the usual MRI protocol.   "
11486|NCT03135561|"     A two-arm parallel randomised controlled trial comparing pedometer-based intervention with     and without email counselling in a primary care setting. Physically inactive patients from     four general practices will be randomised to the pedometer-plus-email group or to the     pedometer-alone group. All patients will be instructed to gradually increase the daily number     of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8     counselling emails based on behavioural techniques. The primary outcome will be change in     average daily steps measured during 7-day period at baseline and at 12 weeks.   "
11487|NCT03135548|"     The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in     patients with PPP following multiple intravenous administrations compared to placebo.   "
11495|NCT03135444|"     The study team created a tool to help identify patients who may benefit from shared decision     making in the primary care setting. This tool is a guide to aid in decision making for     prostate cancer screening. The team proposes the topics to be discussed in the screening     conversation include the risk for developing prostate cancer based upon age, race/ethnicity,     family history of prostate cancer, history of previous digital rectal exam, and history of     previous prostate specific antigen (PSA) as well as self-reported health status and     preferences for treatment. The team now proposes 1) testing this tool first for ease of use     in primary care clinics 2) revising this tool based upon feedback from patients and     providers, then 3) testing this tool for effectiveness in improving patient knowledge that     they have an option to be screened for prostate cancer and of specific factors to be     considered in the screening decision.   "
11496|NCT03135431|"     The purpose of this study is to compare the safety of performing a bilateral tubal ligation     vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the     time of cesarean delivery. The investigators want to determine if performing bilateral     salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as     compared to a bilateral tubal ligation.   "
11591|NCT03134183|"     This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal     misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).   "
11488|NCT03135535|"     Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most     of these ulcers can be treated successfully, some will persist and become infected.     Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will     require amputation of the affected limb.Prevention by identifying people at higher risk is     the key for better clinical management of such patients. It is not uncommon for patients     suffering from diabetes to have concomitant lower extremity edema or even venous     insufficiency and they subsequently may benefit from graduated compression. However, because     of the common association of peripheral arterial disease (PAD) in patients with diabetes,     most clinicians are reluctant to apply compressive dressings in fear of exacerbating the     symptoms of PAD and the possible resulting gangrene.      A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative     means providing lower extremity compression. This device is portable and can be used in a     standard diabetic shoes on daily basis, which in turn may improve venous blood and relief     from concomitant lower extremity edema. In addition, potential improvement in lower extremity     blood flow in response to regular foot compression, could improve balance, gait, skin     perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken     steps per day, duration of standing, etc).      The purpose of this study is to conduct an observational study with N=30 ambulatory patients     with diabetes and loss of protective sensation to assess whether this micro-mobile foot     compression device can help improving motor function, lower extremity perfusion, and vascular     health.   "
11489|NCT03135522|"     The Pilot of Zinc Acetate to Improve Chronic Cough (ZICO) is a study of 36 patients with     chronic refractory cough that will be used to (1) assess if zinc acetate (150 mg/day) will     improve patient reported measures of cough, (2) to establish if treatment with zinc acetate     is well tolerated, and (3) to determine if the trial logistics are feasible.   "
11490|NCT03135509|"     This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative     bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule     formulation, after administration of single oral doses in healthy adult subjects under fasted     conditions.      Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The     sequences will dictate the order in which each subject receives the following treatments:        -  Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg          formulated CC-220 gelatin capsules.        -  Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg          formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.   "
11537|NCT03134885|"     VigilanS is an innovative healthcare program. Participants of this program are all patients     leaving in the Nord-Pas de Calais region who survived a suicide attempt.      General goals of the post hospitalization monitoring system for suicidal attempters are:        -  Standardize general healthcare's practices by offering alert networks and innovative          response procedures in case of suicidal crisis.        -  Coordinate the various health partners' actions around the patient (GP, psychiatrist,          psychologist).        -  Contribute to reducing mortality and morbidity by suicide (subsequent suicide) in          determined territories.      The evaluation of VigilanS will be quantitative and qualitative.   "
11491|NCT03135496|"     Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial     hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is     likely that a significant number of patients suffer from pre-existing endothelial dysfunction     that can be evaluated by a molecular approach.      To date, the replacement of the aortic valve can be performed by surgery with extracorporeal     circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.      Two recent studies have demonstrated a sustained improvement in endothelial function with     TAVI. On the contrary, studies have demonstrated that post-operative complications     (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure)     after surgery with extracorporeal circulation (CEC) could be the result of the interaction     between pre-existing endothelial dysfunction And the operative aggression associated with     the CEC.      Thus, patients with preexisting involvement of endothelial function would develop vascular     dysfunction after valvular replacement due to endothelial activation related to CEC. This     phenomenon would not exist in TAVI, and would explain the absence of so-called vascular     dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome,     disseminated intravascular coagulation).   "
11492|NCT03135483|"     Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of     those admitted to an intensive care unit (ICU), making it among the most common organ     dysfunctions among the critically ill.Major adverse cardiac events (MACE) after non cardiac     surgery are a leading cause of morbidity and mortality. The reported incidence of     postoperative myocardial infarction (POMI) among patients undergoing noncardiac surgery is     between 3% and 6%.The aim of this study is to Identify the impact of acute kidney injury on     the development of myocardial injury after non cardiac surgery and to correlate it with other     risk factors of for MINS.   "
11493|NCT03135470|"     In Finland, there are no guidelines concerning post-operative pain medication of ambulatory     surgery patients. There is a wide variety in drug prescription and medication practices of     various doctors and clinics. To treat patients' pain safely, type of surgery, unique patient     needs, risks, adverse effects and patient's capacity to follow instructions should be     assessed during the few hour visit at the clinic. In many clinics, pain is treated after     hospital discharge with strong opioid oxycodone, but the amount and dose of prescribed     oxycodone varies. In Helsinki Universitys Hospital, Peijas Hospital, investigators have over     2000 ambulatory surgery procedures annually. Investigators have strict policy in oxycodone     use after patient discharge compared to some other Finnish ambulatory surgery clinics. The     aim of this study is to evaluate, whether the prescribed pain medication is sufficient and     whether patients' suffer from adverse effects after discharge from ambulatory surgery (letter     interview). The study proceeds in three phases: 1) observation of current medication     practice, 2) observation after optimization and standardization of hospitals drug     prescription protocol, 3) evaluation of mobile phone app in pain medication follow up.   "
11494|NCT03135457|"     This is an open-label, prospective crossover randomized controlled trial to investigate     wether TACO is solely hydrostatic pressure overload or arises from a combination of     hydrostatic pressure overload and capillary leakage, by investigating the difference in     change in static pressure parameters (PCWP), dynamic volume parameters (PICCO) as indirect     measurements of volume status and capillary leakage after autologous transfusion or saline     infusion. The investigators will estimate effective circulating volume following autologous     transfusion or saline infusion. Furthermore, the investigators will investigate the effect of     fluid loading on the microcirculation.   "
12391|NCT03123432|"     The survey is a phase IV, prospective randomized clinical trial to determine whether an     immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional     status and reduce postoperative infection and surgery-induced immune suppression in patients     with gastric cancer or GIST undergoing major surgery in a single medical center.   "
11497|NCT03135418|"     In this study we aimed to determine whether the additional rehabilitation with 3D virtual     reality headsets provide any functional contribution to conventional rehabilitation     techniques of upper extremity in patient with stroke.      Forty patients with stroke history no more than 2 years will be included in this study.     Patients will randomly be divided into 2 groups as control and intervention. Conventional     rehabilitation techniques will be applied for 4 weeks in both groups. Intervention group will     receive a 3D virtual reality rehabilitation training, each lasts 45 minutes, with a special     headset 3 times a week for 4 weeks in addition to conventional rehabilitation. Patients will     be assessed with Fugl-Meyer, Action Research Arm Test and Functional Independence Measurement     at baseline and 4 weeks after first assessment. It will be evaluated that whether 3d virtual     reality rehabilitation training provides any benefit to stroke rehabilitation.   "
11498|NCT03135405|"     The study evaluates the use of automated motivational messages, visit reminders, and     medication reminders (using interactive voice response technology or text messages) to     improve blood pressure control among adults with hypertension that receive their care at the     First Nations Community Healthsource clinic in Albuquerque, New Mexico. Half of the     participants will receive usual care, while the other half will receive the automated calls     or text messages and have the option to receive home blood pressure monitors and/or designate     a care partner who will also receive messages. Participants will be followed for 12 months.   "
11499|NCT03135392|"     Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and     when nerve sensation to the breast skin returns after mastectomy.      Autologous Tissue Reconstruction: The purpose of this study is to determine whether the     tissue being used to reconstruct your breast can provide sensation by using your own nerves.     Typically all sensation is lost immediately after this type of surgery and returns to varying     degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and     one from the chest wall) together, we can attain meaningful sensation in the transferred     tissues thereby improving your quality of life following surgery.   "
11500|NCT03135379|"     The purpose of this single-blind, randomized control trial will be to investigate whether     simply having warmed gel, as compared to room-temperature gel, during a bedside ultrasound     significantly improves patient satisfaction scores.   "
12480|NCT03121443|"     The association between patient positions including supine,prone, trendelenburg,reverse     trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position and     perfusion index.   "
11501|NCT03135366|"     Each year, 10.4 million patients are diagnosed with and 1.8 million people die from     Tuberculosis (TB). Despite the availability of highly effective and accessible medications in     the developing world where TB is endemic, the 6-18 month treatment regimen is often thwarted     as patients fail to comply due to a lack of knowledge about the disease, desire for privacy,     and/or stigma avoidance. Inappropriate medication use leading to multi-drug resistant (MDR)     TB infects 5% of all TB patients, yet accounts for a significant proportion of all spending.     In Kenya, the burden of TB is among the highest in the world with a prevalence rate of 558     cases per 100,000 people. There is a great need for the development of alternative protocols,     which reduce the costs of treatment and burden of adherence, and more effectively motivate     patients to adhere to the program. A substantial and growing literature in the social     sciences demonstrates the potential of behavioral interventions for generating large     increases in contributions to public goods.      This 1200 participant, Randomized Controlled Trial (RCT) explores the capacity of Keheala, a     feature-phone and Internet-based digital platform that uses Unstructured Supplementary     Service Data (USSD) technology, to deliver behavioral interventions for improving treatment     adherence, outcomes and quality of life for TB patients in Nairobi, Kenya. Keheala taps into     this underutilized potential by developing a powerful, cost-effective platform for better     engaging patients' sense of responsibility to their community in order to increase adherence.   "
11502|NCT03135353|"     comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office     hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during     their reproductive age   "
11503|NCT03135340|"     Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is     increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a     block, unable to perform motor function in the arm, and with patient either intubated or     sedated, unable to follow surgeon instructions intra-operatively. Flexor tendon repair with a     wide awake and cooperative patient is routinely performed successfully at some centres. This     method provides several potential benefits including being able to have the patient actively     flex the digit and visualize the repair site to assess for any tendon gapping at the repair     site, ensure adequate approximation, gliding and absence of triggering. There have not been     any prospectively collected randomized controlled trials comparing wide awake vs.     regional/general anesthesia in flexor tendon repair. The purpose of our study is to assess     for differences in early outcomes including stiffness, patient satisfaction and early     complications in wide-awake anesthesia when compared to general/regional anesthesia for     flexor tendon repair in zones I and II. Our hypothesis is that there is a lower complication     rate and better outcomes when using wide-awake flexor tendon repair.   "
11504|NCT03135327|"     This study to determine the clinical application of advanced ophthalmic imaging devices such     as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy     (SLB), PERG in diseased eyes and normal controls.   "
11505|NCT03135314|"     Not uncommonly, sports events take place or finish at high altitude, where physical and     cognitive (e.g. decision-making, motor control) performance in hypoxia is determining the     outcome of sports performance. With nutritional supplements growing in popularity in the     athletic and non-athletic population, research is increasingly focussing on dietary     constituents which can improve cognitive and exercise performance.      Flavonoids, a subgroup of polyphenols, are a class of natural compounds found in the human     diet and include subcategories of flavanols, flavonols, iso-flavones, flavones, and     anthocyanidins. Intake of flavanols, found in grapes, tea, red wine, apples and especially     cocoa, causes an nitric oxide (NO)-mediated vasodilatation and can improve peripheral and     cerebral blood flow (CBF).      For cocoa flavanol (CF), there is evidence that both long term and acute intake can improve     cognitive function, with the quantity and bioavailability of the consumed CF highly     influencing its beneficial effects and with higher doses eliciting greater effects on     cognition. Increased CBF following acute and chronic (3 months) CF intake has been     demonstrated in healthy young subjects. Moreover, cognitive performance and mood during     sustained mental efforts are improved after acute CF intake in healthy subjects and CF intake     can increase prefrontal oxygenation during cognitive tasks in well-trained athletes.     Moreover, CF intake is not only associated with an improved blood flow, but it might also     improve exercise performance following 2 weeks of dark chocolate intake. On top of that, CF     is known to have anti-oxidant properties and 2 week CF intake has been associated with     reduced oxidative-stress markers following exercise.      In hypoxic conditions, arterial pressure of oxygen (PaO2) and arterial saturation of O2     (SaO2) are decreased, compromising tissue oxygen delivery. Since brain function and brain     integrity are dependent on continuous oxygen supply, brain desaturation may result in an     impaired cognitive function in hypoxia. The severity of the impairment is related to the     extent of high altitude, with at 3000m (=14.3 % oxygen (O2); = 71% of oxygen available at sea     level) psychomotor impairments being visible. Cerebral oxygenation, which can be measured by     Near-infrared spectroscopy, is lowered in hypoxia.      It remains unclear whether CF intake can influence cerebral oxygenation and perfusion in     hypoxic conditions and whether CF intake could (partially) counteract hypoxia-induced     cognitive impairments. Therefore, the first aim of this study was to investigate whether     cognitive function and prefrontal oxygenation during a mental demanding task will be impaired     by hypoxic conditions (3000m altitude; 14.3% O2) and whether these impairments can be     partially restored by subchronic CF intake (7 days, 900 mg/day).      Hypoxia also impairs physical performance. Hypoxia-induced reductions in cerebral oxygenation     may favour central fatigue, i.e. the failure of the central nervous system to excite the     motoneurons adequately, hence impairing exercise performance in hypoxic conditions. Since     hypoxia also impairs oxygen delivery to muscle tissue, the decreased oxygen supply to and     impaired oxidative energy production in the exercising muscle is a second factor negatively     affecting exercise performance.      Besides the aforementioned effects of altitude on O2 delivery, hypoxia also results in     increased oxidative stress. Oxidative stress refers to the imbalance between prooxidant and     antioxidant levels in favor of prooxidants in cells and tissues and can result from     diminished antioxidant levels or increased production of reactive oxygen species. The latter     can be induced by both exhaustive exercise and high altitude. Since oxidative stress can be     counteracted by CF, we also aim to investigate how markers of oxidative stress can be     affected by CF intake by exercise in hypoxia. Therefore, the second aim of this study was to     investigate possible beneficial effects of CF intake on changes in cerebral and muscle     vasoreactivity and oxidative stress during exercise in hypoxia and its implications on     exercise performance.   "
11506|NCT03135301|"     Polycystic ovary syndrome accounts for the vast majority of anovulatory symptoms and     hyperandrogenism in women. The diagnosis of Polycystic ovary syndrome has life-long     implications, with increased risk for infertility, metabolic syndrome, and type 2 diabetes     mellitus, and possibly for cardiovascular disease and endometrial carcinoma. Polycystic ovary     syndrome is diagnosed in adolescents with otherwise unexplained, persistent hyperandrogenic     anovulatory symptoms that are inappropriate for age and stage of adolescence. It should be     considered in any adolescent girl with a chief complaint of hirsutism, treatment-resistant     acne, menstrual irregularity, acanthosis nigricans, and/or obesity   "
11543|NCT03134807|"     -  The primary aim is to document the incidence and short-term outcome of the elderly ICU          patient (≥ 80 years) using a multicentre, multi national approach        -  The secondary aim is to investigate the properties of a simple frailty index in this          cohort, and in particular if this is an instrument that can be used in resource and          outcome prediction in this group        -  To create hypothesis for further studies, in particular on various outcome prediction   "
11507|NCT03135288|"     Unintended and closely spaced pregnancies are a major public health problem that affects not     only the individuals directly involved but also the society indirectly. It increases the     risks of infants with adverse outcomes such as preterm, low birth weight and small for     gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold     increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold     increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce     unwanted pregnancy, high fertility and maternal mortality rates.   "
11508|NCT03135275|"     The primary objective of the trial is to compare, in patients presenting with ST elevation     myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of     immediate complete primary percutaneous coronary intervention (PCI) of all target vessels     versus culprit vessel only revascularization, followed by staged PCI (within minimal 19 and     maximal 45 days) of all target vessels, in a non-inferiority trial, using a third generation     biodegradable-polymer everolimus-eluting stent (Synergy™).   "
11509|NCT03135262|"     This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will     evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with     idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in     combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will     include an initial dose-escalation phase followed by an expansion phase. The dose-escalation     phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for     idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in     combination with rituximab for DLBCL participants.   "
11510|NCT03135249|"     The purpose of this study is to determine if a sequential combination therapy of natalizumab     and alemtuzumab induces peripheral tolerance and reduces the annualized relapse rate (ARR) in     patients with relapsing-remitting multiple sclerosis (RRMS).   "
11639|NCT03133559|"     Individuals infected with HIV have a high risk of developing metabolic comorbidities not     traditionally associated with the immune dysregulation and deficiency associated with HIV     infection and AIDS. Many of these comorbidities in HIV uninfected individuals have been     linked to a disordered circadian clock function. The study investigators will further     evaluate the circadian clock in HIV infection as a mechanism underlying the metabolic     dysregulation in this population.   "
11511|NCT03135236|"     By integrating sexuality and disability literatures, theories, and research methodologies,     this study aims to: 1) contribute to the limited knowledge professionals have of parents as     the primary sexuality educators; 2) create a resource for parents in order to be sexuality     educators for their young adults with I/DD; and 3) evaluate the effectiveness of the Home     B.A.S.E. for Developmental Disabilities Curriculum.      In order to meet the objectives the study seeks to answer the following questions:        1. What is the effectiveness of a sexuality education workshop for parents of young adults          with DS on improving the self-efficacy and attitudes around sexuality and healthy          relationships for young adults with DS as well as increase the parent-child          communication on sexuality topics?        2. What are parents' concerns that impact their ability to be the primary sexuality          educators for their young adults with DS? It is proposed that parent confidence and          comfort talking about sexuality topics with their young adult with Down syndrome will          increase thereby increasing the parent-child communication as a result of this study.   "
11512|NCT03135223|"     Secondary schoolgirls have the most unhealthy profile regarding physical activity and     sedentary behaviour of all age groups. Since both behaviours independently contribute to     various health outcomes, an effective intervention to promote physical activity and to reduce     sedentary behaviour needs to be developed.      Many interventions fail to induce changes in health behaviour, as they often use a top-down     approach with limited input from the end-users (i.e. the secondary schoolgirls) of the     intervention programmes. This project uses a participatory health research approach by     actively involving the girls in the entire research process. A co-creation group was set up     per intervention school (n=3), including girls and a researcher which co-created a     school-specific intervention, tailored to the needs and interests of those girls.      The effect of participatory process were evaluated via a clustered randomized controlled     trial using an intervention and control condition and a pre- and post-test design. Effects on     physical activity and related determinants (e.g. self-efficacy, attitude, etcetera) were     evaluated. The hypothesis was that girls from the intervention condition would improve their     physical activity levels and related determinants compared to no changes among girls from the     control schools. The process was evaluated as well using focus group research and the     hypothesis was that girls who participate in the co-creation groups would be positive about     the process and will feel empowered.   "
11513|NCT03135210|"     The primary aim of this study is to assess the functional impact of leg exercise during the     pre-ambulation phase in patients undergoing ECMO. Outcome measures will be categorized as     either functional or hospital based. Hospital measures include: Hospital days, intensive care     unit days, days on ECMO, days on mechanical ventilation, length of time from physical therapy     evaluation to initial ambulation, and discharge disposition. Functional outcome measures     include: Leg strength, grip strength, 30-second sit to stand test, Functional Status Score     for the Intensive Care Unit (FSS-ICU), and the Richmond Agitation and Sedation Scale (RASS).   "
11514|NCT03135197|"     The objective of the study is to document long term data on treatment with Migalastat under     real world conditions. The selection of patients is based on the SmPC/Fachinformation. The     study duration/patient will be 2 years.   "
11515|NCT03135184|"     Assess the effect on coronary atheroma of serial infusions of autologous selectively     delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System   "
11517|NCT03135158|"     The present study aims to determine the relationship between postpartum changes in the shock     index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood     pressure will be systematically measured in the postpartum period in all participating women     to explore new clinical indicators to identify those requiring clinical intervention for     excessive bleeding.   "
11571|NCT03134443|"     A multicenter, randomized, single-blind, placebo-controlled,phase 4 clinical trial to     evaluate the efficacy and safety of andrographolide sulfonate in patients with acute     tonsillitis   "
11572|NCT03134430|"     It has been reported local anesthetics could inhibit tumor cell proliferation, metastasis and     invasion ability，but it still lacks clinical evidence. Our study aims to explore the effects     of regional nerve block on cancer recurrence and the mechanism.   "
11518|NCT03135145|"     Lite Run is a new assistive device that may have FDA listing as a Class I device by mid 2017     based on clinical testing of adults, independent agency testing and in-house evaluations.      This will be a combined study with multiple purposes with respect to the evaluation of its     use with the post-operative pediatric population. A first purpose is to verify safety and     feasibility of the device on pediatric patients. A second purpose is to statistically test     the effectiveness of Lite Run to decrease physical burden on the therapist during     post-operative gait training for children and adolescents with cerebral palsy as compared to     current methods of body weight-supported gait training. A third purpose is to measure and     qualitatively evaluate the effectiveness of the device on patient outcomes and improving     patient and therapist satisfaction.   "
11519|NCT03135132|"     To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma     metabolites and metabolic traits from baseline.   "
11520|NCT03135119|"     This study will examine the incremental benefit of animal-assisted therapy (AAT) as an     adjunct intervention when combined with Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT)     for the treatment of maltreated youth. In addition, the development of therapeutic rapport     and the intensity of stress experienced during treatment sessions will be examined as     mediational mechanisms of treatment outcome. This project will help determine whether a     larger study to test the beneficial effects of AAT for maltreated youth is feasible and     warranted.   "
11521|NCT03135106|"     The purpose of this study is to evaluate the effect of multiple doses of fluconazole (an     inhibitor of cytochrome P450 [CYP] 2C9 and CYP3A) and itraconazole (an inhibitor of CYP3A4     and P-glycoprotein [P-gp]) on the pharmacokinetics of a single 4-milligram (mg) oral dose of     erdafitinib in healthy adult participants.   "
11522|NCT03135093|"     This project is a cross-sectional, observational mono-center study with prospective data     collecting.      This study aims to further explore quality of upper limb movement in relation to     characteristics of visuospatial exploration in stroke subjects and healthy subjects by a     applying comprehensive measurements of clinical scales and kinematic data in capacity- and     performance-based activities. The results will contribute to assessing and monitoring quality     of upper limb movements and visuospatial attention and their relationship.   "
11523|NCT03135080|"     The research group developed a surgical simulation device, the Human Eyelid Analogue Device     for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap     between classroom and live-surgery training specifically for trichiasis surgery. In most     settings, HEAD START is utilized once during training, then surgeons move on to live surgery     and typically do not return to the simulator. The research team is interested in determining     whether HEAD START provides benefit for long-term trichiasis surgery training, since many     surgeons operate seasonally, with long periods of downtime between surgical camps and with     little field supervision.      Participating surgeons will practice on HEAD START weekly, with monthly feedback from a     senior supervisor. Researchers will assess their skill level at the start of HEAD START     training and again at the start of the new surgical season in the fall of 2017. Researchers     will also administer questionnaires to elicit feedback on the HEAD START training and     supervision process.   "
11524|NCT03135067|"     This cluster randomized trial will assess whether the provision of multiple oral-fluid based     HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an     approach that promotes HIV testing among women's sexual partners, facilitates better sexual     decision making, and reduces women's risk of acquiring HIV.   "
11525|NCT03135054|"     The study aims to test if combination of quizartinib (AC220) and omacetaxine mepesuccinate     (OM, also known as homoharringtonine) results in durable composite complete remission (CRc)     in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML)     carrying FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).   "
11526|NCT03135041|"     The aim of this study is to investigate whether a diet supplemented with two prebiotic fibres     induces greater changes in body weight compared to placebo during 12 weeks of energy     restriction in an obese/overweight population.      The hypothesis is that the fiber-containing dietary supplement will:      1) Induce greater changes in body weight compared to the placebo group 2) change the gut     microbiota composition 3) improve glucose homeostasis 4) decrease serum concentration of     triglycerides, total and LDL cholesterol      The hypothesis is that the effect of the intervention on weight loss will be partly mediated     by the diet-induced changes in the gut microbiota composition.   "
11527|NCT03135028|"     The primary objective of this study is to evaluate the safety and tolerability of     Entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese     participants   "
11528|NCT03135015|"     Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After     a normal meal, carbohydrates are broken down into glucose (blood sugar) which is absorbed     from the intestine into the blood leading to a rise in blood glucose which triggers the     secretion of insulin. Insulin binds to cells in the liver, muscle and fat, triggering them to     take up glucose and bring the blood glucose level back to normal.      A high blood sugar level is known as diabetes. The most common form of diabetes, type 2     diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate     glucose uptake into cells. The body compensates for insulin resistance by making more     insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to     control blood glucose. The high blood glucose and insulin levels lead to long-term     complications such as heart attacks, kidney failure, reduced sensation and poor circulation     in the feet and legs. Reducing blood glucose levels with oral medications and insulin reduces     risk of diabetes complications. There are several types of oral medications available for     treating diabetes; however, they do not always control blood glucose adequately. In addition,     these drugs have complications and are not used to treat insulin resistance and pre-diabetes;     a condition when blood glucose is higher than normal but not high enough to be called     diabetes. Pre-diabetes often progresses to diabetes over a period months or years. Effective     and safe treatments for pre-diabetes could prevent or delay the onset of diabetes.      Axulin is a natural health product consisting of a mixture of extracts from herbs and     vegetables present in normal diets which has been shown in cell-culture (cells grown in the     laboratory) and in animal studies to increase the ability of insulin to stimulate glucose     uptake into cells. Thus, Axulin may reduce the blood glucose and insulin levels of subjects     without diabetes after eating. Also Axulin may reduce glucose and insulin responses more in     insulin-resistant compared to insulin-sensitive subjects.      Subjects will take 0g, 2g or 4g or Axulin capsules or Axulin tablets in the morning after an     overnight fast; 40min later they will then consume 75g glucose dissolved in 300ml water.     Blood glucose, insulin and fats will be measured before and for 2 hours after the glucose     drink.   "
11573|NCT03134417|"     The purpose of this study is to investigate the effects of a combined vitamin D and magnesium     supplementation on parathyroid hormone and cardiometabolic health in persons living with     obesity.   "
12392|NCT03123419|"     The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a     maternal fetal Care Center. This will be done by reminding patients via text to come for     follow up vaccine appointments.   "
11529|NCT03135002|"     Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is     independently associated with increased cardiovascular (CV) disease risk. This risk increases     as CKD advances both in relation to worsening glomerular filtration rate and development of     proteinuria. The overall cost of CKD to the NHS in England has been estimated as £1.45     billion per annum, or 1.3% of the NHS's total budget. This includes £175 million, or 13% of     the CKD budget, annually spent in relation to 19,000 excess myocardial infarctions and     strokes related to CKD.      The epidemiology of CKD in primary care is poorly studied. This is particularly the case in     non-white populations who have an independent higher risk of progression to end stage renal     failure (requiring dialysis or transplantation), CV events and death.      Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by     CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores.     However, all the risk scores had significant methodological limitations, such as a lack of     external validation or the perception that they were not 'clinically useful'. The Leicester     City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP     records of individuals with CKD. We will aim to retrospectively create a cohort with 5 years     follow-up to the present day. In addition, a present day cohort will be created to both aid     research and provide data for practices and clinical commissioning groups for quality     improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in the cohort.      The principal objectives of the study are:        1. To study the natural history of CKD in a multi-ethnic primary care setting        2. To contribute to the creation of a risk prediction tool for heart attacks and strokes in          CKD      The risk prediction tool would more accurately stratify risk of CV events for individuals     with CKD. This would aid patients and clinicians in deciding on treatments aimed at reducing     the risk of future myocardial infarctions and strokes. Currently, individuals with CKD,     despite higher risk of CV disease, may not be receiving optimum treatment such as statins and     anti-hypertensive medications. Improved management of cardiovascular risk factors in CKD is     likely to see a reduction in CKD associated excess CV events and their associated costs,     including longer average duration of inpatient admissions.   "
11538|NCT03134872|"     SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III,     multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with     carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy     naive and have Stage IIIB/IV non-squamous NSCLC.      The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs     Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review in     NSCLC Subjects (ITT population and population was indicated by high PD-L1 expression)     compared to carboplatin and pemetrexed treatment .   "
11640|NCT03133546|"     BOOSTER is a randomised, controlled, phase II trial comparing osimertinib and bevacizumab     versus osimertinib alone as second-line treatment in patients with stage IIIb-IVb non-small     cell lung carcinoma (NSCLC) harbouring activating EGFR (exon 19 deletion or L858R) and T790M     resistance mutation.   "
11530|NCT03134976|"     This is a prospective observational study evaluating wound complications following head and     neck surgery. Patients undergoing major head and neck surgery will be included in the study.     Patients meeting eligibility criteria will be identified by members of the University of     Michigan Head and Neck Oncology Division of the Department of Otolaryngology. The primary aim     of this study is to identify risk factors for poor wound healing as well as biologic markers     associated with wound related complications in head and neck surgery. Most specifically, this     study evaluates the effects of thyroid hormone on wound healing. This study will also     evaluate pre-operative labs and comorbidities as well as reconstructive factors,     post-operative labs, and other variables associated with wound healing. All interventions     regarding wound healing fall under current standards of care and standard practice. Data     regarding post-operative wound complications will be collected in a prospective fashion on     the variables under study using study-specific datasheets. Data sheet will be entered into a     secure database for analysis.   "
11531|NCT03134963|"     850,000 people live with dementia in the UK, with that number expected to rise to more than 1     million within the next 5 years. The most common type of dementia (55%) is Alzheimer's     dementia, and vascular dementia is the second commonest type (15%). Mild cognitive impairment     (MCI) affects up to 20% of older adults and describes a set of symptoms rather than a     specific medical condition or disease. A person with MCI has subtle problems with one or more     of the following: day-to-day memory, concentrating, planning or organising, language (eg     struggling to find the right word), and judging distances and seeing objects properly.     Although MCI significantly increases the risk of developing dementia (by up to 5 times), at     present it is not possible to accurately predict which patients with MCI will progress to     dementia. In recent times there has been an increasing awareness that problems with brain     blood flow may contribute to the development, or progression, of dementia. Tests of mental     abilities, with standardised questions and pen-and-paper tests are a key component of the     formal diagnosis of dementia, yet little is known of the effects of these tests on brain     blood flow. Brain blood flow can be can be assessed non-invasively by the use of Trans     Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to     measure changes in blood flow in one of the main brain arteries (the middle cerebral artery).     This proposed study will therefore use TCD to evaluate changes in brain blood flow during     performance of the Addenbrooke's-III (ACE-III) cognitive assessment in four key groups of     patients, specifically:        1. Healthy older adults        2. Patients with mild cognitive impairment (MCI)        3. Patients with vascular dementia        4. Patients with Alzheimer's dementia   "
11532|NCT03134950|"     This project aims to test a stepped care behavioral intervention approach for youth with     functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening     and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth     with FAP with more than minimal functional disability (FDI score >7) during their medical     visit as part of enhanced usual care (EUC). Patients are re-assessed after two weeks. Those     that fail to respond to EUC (as evidenced by FDI score >7) are eligible to undergo a baseline     assessment and then are randomized to receive either 1) a more intensive and tailored CBT     approach, Aim to Decrease Anxiety and Pain Treatment (ADAPT), provided by a trained     psychologist, or 2) medical treatment as usual (TAU). It is hypothesized that youth who     participate in ADAPT will have lower average pain rating scores, less pain-related functional     disability, and less anxiety symptoms (if elevated) at post-assessment as compared to youth     receiving medical TAU.   "
11533|NCT03134937|"     High Flow Heated and Humidified Nasal Oxygen therapy (HFNO) has been increasingly used in     emergency medicine to assist patients with short term respiratory failure and to provide     adequate oxygen to the body prior to intubation. Gastric distension which is the bloating of     the stomach due to air being pumped into it is a concern for anesthesiologists as it     increases the risk of nausea and vomiting during surgery (aspiration). The objective of this     study is use an ultrasound machine to measure the volume of fluid in the stomach before and     after HFNO is used in a standard clinical manner.   "
11534|NCT03134924|"     Intravaginal practices (IVP) (cleansing or introducing products inside the vagina for     hygiene, health or to please sexual partners) are common among women with HIV. IVP increase     the risk of developing bacterial Vaginosis (BV), the most common genital infection associated     with transmission of sexually transmitted infections and HIV. This study tested a pilot     intervention to reduce IVP and BV in HIV infected women in Zambia. A total of 128 HIV     infected women engaging in IVP were randomized to two conditions: enhanced standard of care     (n = 70) and experimental (n = 58). All participants received a brief educational counseling     session on discontinuation of IVP, and those with BV, were provided with medical treatment     for BV. Women in the experimental condition received an additional group-based, culturally     tailored intervention. Participants completed questionnaires assessing sexual risk factors     and IVP and were assessed for BV using Nugent criteria at baseline, 6 months and 12 months.   "
11535|NCT03134911|"     The present study has been designed to describe the health-related quality of life in     patients with non valvular atrial fibrillation who have been prescribed a specific     anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to     study initiation. It will be conducted in Departments of Internal Medicine from approximately     50 centers in Spain. It consists of an only visit that will coincide with one of those     performed by the patients as part of routine follow-up of their disease. 500 patients seen in     internal medicine are planned to be included in the study   "
11536|NCT03134898|"     The current data on the incidence of pulmonary hypertension (PH) are very variable, depending     on the different studies designs. There are no data on the prognostic of PH in patients with     asymptomatic pulmonary thromboembolisms (PT), neither paucisymptomatic PH, in which without a     prospective follow-up would be underdiagnosed. We thought that the prognosis of both clinical     forms (PT with or without symptoms) would be similar.      The objective of this study is know the real incidence of pulmonary hypertension (PH) post     symptomatic and asymptomatic pulmonary thromboembolic (PT).   "
11549|NCT03134729|"     A randomized prospective trial to assess whether the use of loco regional anesthesia as     adjuvant analgesic therapy is more effective of intravenous analgesia only.   "
11641|NCT03133533|"     Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia     repair.   "
11642|NCT03133520|"     Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute     hypoxemic respiratory failure   "
11539|NCT03134859|"     The proposed study is a longitudinal, randomized control trial designed to determine the     dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and     healthy body composition. Infants will be randomly assigned to one of three 'tummy time'     groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per     day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to     achieve the maximal minutes prescribed for their group and will keep a log of their daily     tummy time. Participating infants will be assessed in their home for motor development and     body composition at study entry and again every month for 12 months, at 15 months of age and     at 18 months of age.   "
11540|NCT03134846|"     Surgery remains a main pillar in the treatment of head and neck squamous cell carcinoma     (HNSCC). The margin status is the main prognostic factor of local tumor control in surgically     treated HNSCC and will determine the postoperative treatment strategy. A margin of ≤1 mm of     normal tissue is considered a positive margin and requires either a re-operation or     postoperative chemoradiation with a combination of cisplatin and 5-FU, which substantially     increases morbidity. Margins wider than 1 mm but less than 5 mm require re-operation, or, if     that is not possible, post-operative radiotherapy without the concomitant use of     chemotherapy. Currently, no technology is available in the operating room, which reliably     supports tumor excision in terms of margin status. In fact, surgeons can only combine pre-     operative imaging data with tactile and visual information during surgery for assessing tumor     margins with limited accuracy. With the introduction of molecular imaging techniques using     near infrared (NIR) fluorescent optical contrast agents coupled to targeted compounds, new     avenues have opened up for intra-operative assessment of tumor margins. Tracers are based on     antibodies directed against Vascular Endothelial Growth Factor-A, i.e.     bevacizumab-IRDye800CW, in patients with breast cancer or against Epidermal Growth Factor     Receptor, i.e. cetuximab-IRDye800CW, in patients with HNSCC. First trials have shown that     systemic administration of these compounds is safe and tumor specific. These findings     prompted us to design this innovative application in a clinical trial for the intraoperative     assessment of tumor margins during surgical treatment of HNSCC using cetuximab-IRDye800CW.   "
11541|NCT03134833|"     The focus of this study (Engaging Seronegative Youth to Optimize HIV Prevention Continuum) -     will be to stop HIV-related risk acts and to encourage youth at high risk for HIV to adopt     antiretroviral medications as treatment and prevention (either pre exposure prophylaxis     (PrEP) or post exposure prophylaxis) among gay, bisexual and transgender and/or homeless     youth with contact with the criminal justice system in the HIV epicenters of Los Angeles and     New Orleans. A cohort of 1500 youth at the highest risk of seroconverting over 24 months will     be identified. The goal will be to optimize the HIV Prevention Continuum over 24 months. The     proposed randomized controlled trial (RCT) aims to compare youth outcomes when randomized to     one of four automated and person-mediated social media delivered intervention conditions: 1)     Automated Messaging and Monitoring Intervention (AMMI) only (n=900) consisting of daily     motivational, instructional, and referral text-messaging (SMS), and brief, weekly SMS     monitoring surveys of outcomes; 2) Peer Support through social media plus AMMI (n=200) via     private online discussion boards; 3) Coaching plus AMMI (n=200) to provide service linkages,     eligibility support, appointment coordination and follow-up, communication with healthcare     providers, and brief motivational and strengths-based counseling for linkage and retention to     prevention, mental health, and substance abuse services; and, 4) Coaching plus Peer Support     and AMMI (n=200).   "
11542|NCT03134820|"     Cancer is the most important acquired risk factor of thromboembolisms. More than 20% of all     episodes of venous thromboembolism (VT) or pulmonary thromboembolisms (PT) are cancer     related. Cancer patients with VT or PT are treated with low molecular weight heparins (LMWH)     during at least 3 months, but nowadays the duration of treatment is not accurately     determined.      The D-Dimer determination has been used like recurrence predictors after LMWH treatment     suspension, but in cancer patients the useful is limited. Phospholipid-dependent     microparticles could been used like recurrence predictors in cancer patients and tailored the     duration of LMWH treatment for each patient.   "
11544|NCT03134794|"     The main objectives of this study are:      i) To design an educational tool to train physicians in overcome cognitive factors associated     with therapeutic inertia.      ii) To determine the feasibility and efficacy of an educational tool to overcome therapeutic     inertia among neurologists caring for MS patients      iii) identify the best strategy to disseminate an educational program to train physicians     taking into account regional and practice variations.      iv) To explore whether multiple sclerosis (MS) patients' risk category influence the     incidence of therapeutic inertia in neurologists that may require a segmentation strategy in     medical education.      A multicenter, randomized, study including an educational intervention (applying the traffic     light system) to overcome therapeutic inertia in MS care.   "
11545|NCT03134781|"     In this study the investigators utilized a novel hybrid HIIT (high intensity interval     training) exercise training approach, the Fun and Functional Interval Training (FFIT) workout     that combines interval training, resistance exercise training and functional training in     order to test the hypothesis that FFIT will be able to: i) reduce body mass, ii) improve body     composition and iii) alter energy balance, of previously inactive, overweight/obese women.   "
11546|NCT03134768|"     The purpose of the study is to understand the immediate effect of birth on immunological     parameters in vaginally born cord blood.   "
11547|NCT03134755|"     This study aims to first determine whether high child stress leads to reduced response to     common treatmenIs for asthma (inhaled corticosteroids and short-acting bronchodilators), and     then to identify DNA methylation differences leading to stress-induced treatment resistance     among children with asthma.   "
11548|NCT03134742|"     Post-radiotherapy fragility fractures (caused by weakened bones) are an occasional     complication of orthopedic oncology of soft tissue sarcoma patients. Treatment for impending     fracture due to radiotherapy does exist in the form of operative stabilization, to prevent     the bone from breaking. Without the ability to predict those patients at a higher risk for     fracture, indications for treatment are difficult to determine. This study is to determine if     there is a correlation between patients undergoing radiotherapy for soft tissue sarcoma and     loss of bone density. The study wll evaluate bone loss for short and long term fracture     prediction using dual-energy xray, absorptiometry (DEXA [DXA]) and computerized tomography     scans (CT Scans)   "
11550|NCT03134716|"     Our aim is to evaluate whether translocator binding protein (TSPO)-imaging correlates to     Expanded Disability Status Scale (EDSS) and other disease progression-related clinical and     paraclinical parameters in a homogenous cohort of 40-50-year old MS-patients, who are at risk     of progression. The A2A-AR expression in this cohort will also be studied using the adenosine     A2A-receptor (A2A-AR)-binding radioligand 11C-TMSX. The study cohort will also form the basis     for a later follow-up study, which will be performed to evaluate the prognostic value of     baseline TSPO-imaging in terms of disease progression. TSPO-imaging could thus be used as an     imaging biomarker to help identifying patients to therapeutically prevent progression of MS.   "
11551|NCT03134703|"     This project provides a novel approach and an alternative care plan for infants with Neonatal     Abstinence Syndrome (NAS). It is funded by the State of Florida and allows to: 1) educate and     empower a specified population of mothers who are undergoing institutionalized rehabilitation     and whose infant needs treatment for NAS; 2) safely transition the infants home for final     wean of their pharmacologic treatment; 3) provide regular developmental follow up for these     infants through our NICU follow up clinic, hence identifying and quickly responding to     neuro-developmental delays.   "
11552|NCT03134690|"     The main outcome measures are the number of dominant follicles (≥13 mm) on the day of hCG     trigger and the number of mature (MII) oocytes collected after conventional versus     delayed-start ovarian stimulation protocol. Secondary outcome measures are including total     number of oocytes retrieved, oocyte maturity rate (number of MII oocytes/total number of     oocytes), oocyte yield (total number of oocytes retrieved/ antral follicle count [AFC]),     mature oocyte yield (number of mature oocytes retrieved/AFC), total dosage of gonadotropin     (recombinant FSH and/or highly purified hMG) needed, number of days needed for ovarian     stimulation, quality of obtained embryos, fertilization rate (the proportion of total number     of two-pronuclear [2PN] stage zygotes /per total injected MII oocytes), implantation rate     (total number of observed gestational sac/ number of transferred embryos) and clinical     pregnancy rate (presence of fetal heart beat by transvaginal ultrasound per embryo transfer).   "
11553|NCT03134677|"     This study evaluates the effects of different anesthetic techniques on QT, QTc, and Pwd in     cesarean section. Half of participants received general anesthesia, while the other half     received spinal anesthesia Electrocardiography (ECG) recordings were performed at     preoperative, 5, 15, 30 min after initiation anesthesia and 30 min post-operatively.     Hemodynamic state were also recorded at the same time intervals. QT, corrected QT (QTc), QT     dispersion (QTd), QTc dispersion (QTcd), P-wave dispersion (Pwd), corrected JT interval, T     wave (Tp-e), transmular dispersion of repolarization durations were measured from ECG records     at predetermined time intervals of spinal or general anesthesia.   "
11554|NCT03134664|"     To test that the SuperPATH approach is more safe and reliable for hip functional recovery     compared with the postolateral approach in the artificial hip replacement for femoral neck     fractures in the elderly.   "
11555|NCT03134651|"     This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF     success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score:     a low-anxiety group, while the other half high-anxiety group.   "
11556|NCT03134638|"     This study will consist of two parts. Part 1 is a dose-escalation/safety evaluation to     provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2.     Approximately 35 patients with advanced solid tumors will be enrolled into Part 1 of the     study.      Following the identification of a recommended dose and regimen from Part 1, the study will     enter Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients     with select solid tumors, and to confirm target engagement and downstream pathway impact in     patients with any solid tumor histology. Part 2 will consist of two cohorts:        -  Cohort 1: approximately 25 patients with small cell lung cancer (SCLC), triple negative          breast cancer (TNBC), or ovarian cancer (OC)        -  Cohort 2: approximately 10 patients with biopsy-accessible, advanced solid tumors of any          histology   "
11557|NCT03134625|"     The development of acute rejection can only be considered in cases with increasing serum     creatinine in patients with kidney transplantation. However, the serum creatinine itself is     not specific but also accurate for detection of acute rejection. So The specific biomarker is     required for acute rejection of kidney transplant. In this study, the investigators will     enroll 200 consecutive kidney transplant patients in Seoul National University Hospital and     follow up. Serial collection of urine and serum will be done. Acute rejection specific urine     metabolite will be found by LC MS/MS.   "
11558|NCT03134612|"     This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in     preventing pain due to propofol injection   "
11559|NCT03134599|"     The purpose of this study is to evaluate the clinical performance and subject's preference     out of three LRE (Limbal Ring Enhancing) lens types: enfilcon A (Johnson&Johnson),     methafilcon A (Interozzo), and methafilcon A (CooperVision).   "
11560|NCT03134586|"     The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam     colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR     enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity     in patients with suspected CD compared to the traditional invasive approach using     ileocolonoscopy with biopsies as first line diagnostic modality   "
11561|NCT03134573|"     The planned study will be a prospective, non-interventional, observational cohort study using     the structure of a registry. Medication usage behavior will be observed for 6 months, while     documentation behavior on the wellness tracker in the myBETAapp will be observed for 3     months.   "
11562|NCT03134560|"     This study aims to compare intravenous cannulation success rate between using vein display     instrument and without using vein display instrument in pediatric patients.   "
11563|NCT03134547|"     This study was performed to compare the incidence of EA between two dose of sevoflurane for     sedation with caudal block in children, and intended to find the optimal dose for prevention     of sevoflurane induced emergence agitation   "
11564|NCT03134534|"     Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical     safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the     oncological long-term outcomes of RATS lobectomy has not been studied by randomized     controlled trial, the purpose of this study is to determine whether RATS lobectomy would be     as effective as VATS lobectomy on short-term and long-term outcomes.   "
11565|NCT03134521|"     Daptomycin is validated as a treatment of bone and joint infections by the Infectious Disease     Society of America. However, most of studies did not investigate daptomycin pharmacokinetics     in this indication while it is known that efficacy and toxicity concentration studies show a     close therapeutic margin.      Evaluation of P-Glycoprotein (P-gp), a transmembrane transport protein, has demonstrated its     influence on the concentration and intracellular activity of daptomycin. Recent work has     linked the genetic polymorphism of P-gp to the pharmacokinetics of daptomycin, which may     explain inter-individual variability but requires further explorations. Previous studies     demonstrated existence of interindividual variabilities as sex, renal function and     p-glycoprotein polymorphism couple with an intraindividual variabilities unexplained yet.      A population approach will be used to determinate the pharmacokinetics factors, their intra     and interindividual variabilities, the parameters associated to those variabilities (as the p     glycoprotein).      The investigator's goal is to evaluate different posology and to try to increase daptomycin     efficacy and security in bone and joint infection.   "
11566|NCT03134508|"     : Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC)     need long term treatments which can conflict with a desire of pregnancy in women.     Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor     α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of     treatment-related complications. Existing recommendations on the use of antiTNFα during     pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess     appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women     with IBD, for both the mother and the baby until the end of the first year.   "
11567|NCT03134495|"     Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive     in France, as 65%-85% of children below 11 years are being treated, frequently with Proton     Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection     rate but data in pediatry are scarce, especially in community medecine. Recently a study     conducted in England brought up controversial results suggesting that the use of PPIs can be     associated with a reduced risk of community acquired pneumonia.      Our study was aimed to assess, on a population-based database, the association between PPI     prescription and community infections in children of 11 years or under.   "
11568|NCT03134482|"     Polycystic ovarian syndrome (PCOS) is most common endocrinologic disease in women of     reproductive age with incidence of 6.6 ~ 8%. About fifty percent of the patients with PCOS     manifest subfertility and significant proportion of these woman need assisted reproductive     technology (ART). These patients are very sensitive to gonadotropins during conventional in     vitro fertilization (IVF) and the risk of ovarian hyperstimulation syndrome (OHSS) is high.     In vitro maturation (IVM) is an emerging alternative option to conventional IVF for     minimizing the risk of OHSS in patients with PCOS. Until now, several studies has been     reported the favorable outcomes of oocyte muturation rate, fertilization rate, clinical     pregnancy rate, and live birth rate during IVM procedure. However, these results were from     retrospective or observational study and there was no suitable randomized controlled trial     (RCT).      Therefore, this prospective RCT is aimed to compare and analyze the clinical outcomes between     IVM and minimal stimulation IVF in women with PCOS, assessing if IVM is recommendable     clinical practice or not.   "
11569|NCT03134469|"     Efficacy of probiotics on excessive gas accumulation   "
11570|NCT03134456|"     This is a single center, open-label, single arm study in patients with metastatic non-small     cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination     chemotherapy.      Patients will be treated with Pembrolizumab according to the dosage and administration in     Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose.      The patient should have their-own patient-derived xenograft (PDX) before enrollment of the     study. The PDX will be used to set up their humanized CD34 PDX (Hu-CD34 PDX).   "
11574|NCT03134404|"     The skeletal system is one of the most common sites for metastatic spread of many     malignancies. Metastatic bone disease (MBD) can be associated with a significant reduction in     quality of life due to debilitating pain and pathologic fractures. Multiple providers are     involved in treating patients with MBD which can result in fragmented and delayed delivery of     care. This fragmentation also leads to poor outcomes and patient experience. This project     will assess whether it is feasible to integrate a multidisciplinary Rapid Access Metastatic     Bone Disease Program (RAMP) at the Investigator's institution to improve the delivery of care     to patients presenting with pelvic and lower extremity MBD. The goals of RAMP are: 1) Improve     outcome and quality of care provided to MBD patients. 2) Improve patients experience through     the participant's treatment journey. 3) Avert extra health care costs caused by unplanned     admissions through ER and decrease redundancies due to unnecessary multiple clinic visits and     double-ordering of diagnostic tests. This project will be designed to optimize the use of     existing clinic resources more efficiently. Cancer patients and their loved ones will be     actively engaged in the design of this project to better achieve its goals.   "
11575|NCT03134391|"     This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from     spinal injection   "
11576|NCT03134378|"     Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the     half population in the world. Colonization of this bacteria is suspected to be one of the     main risk factor for the occurrence of various abnormalities of the upper gastrointestinal     tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple     therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The     recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple     therapy with longer duration will provide a higher percentage of eradication. This study     wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter     pylori eradication.   "
11608|NCT03133962|"     Given the increase in the number of PAC implants or long-term catheters, and the ease of     access to cardiac ultrasound in the operating theaters, the investigator thought to use     ultrasound to PAC or long-term catheters.      The investigator considers cardiac echocardiography through its costal pathway to locate the     correct positioning of the distal end of the catheter in a manner equivalent to the scopic     locating with all the side effects of the irradiation and with Equivalent efficiency   "
11577|NCT03134365|"     Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and     emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses     to conventional (potato and cheese cream followed by vanilla cream) versus unconventional     test meals (mixture of both creams) with identical composition (350 Kcal) and physical     characteristics (colour, texture, consistency, temperature) but distinctively different     palatability will be studied on a cross over-design. The responses to the meals will be     tested on 2 different days.      Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day     before, to consume a standard breakfast at home after overnight fast, and to report to the     laboratory, where the test meal will be administered 5 h after breakfast. Studies will be     conducted in a quiet, isolated room with participants sitting on a chair. Perception will be     measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals     up to 60 min after the probe meal.   "
11578|NCT03134352|"     This is a double-blind, randomized, placebo-controlled multi-center phase IIA study to     evaluate the clinical efficacy and safety of Fugan ointment versus placebo applied to     involved skin of subjects with mild to moderate subacute eczema.   "
11579|NCT03134339|"     The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project     addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence     threshold among youth and adults and impact of nicotine reduction on tobacco product use     behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and     relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is     necessary for accurately assessing dose-response and threshold effects. The estimated     threshold for reinforcement will establish a benchmark for evaluating the addictive potential     of ECs and other inhaled nicotine products.   "
11580|NCT03134326|"     In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter     sensors and compared against the hemoglobin measurement from the subject's blood sample under     controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the     device's 8-17 g/dL specification range.      The purpose of the study was to evaluate a change in the sensor component and to assess     performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not     uniform across the accuracy range.   "
11581|NCT03134313|"     In this study, the concentration of hemoglobin will be measured using a noninvasive pulse     oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer.     The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to     hemoglobin measurements from a laboratory analyzer.   "
11582|NCT03134300|"     The investigators wish to study the role of persistent markers of inflammation in executive     function in young children during critical periods of synaptogenesis (ages 2-3). While the     role of markers of inflammation have been validated in the pathogenesis in multiple disorders     in the adult population, their study in pediatrics is limited. The investigators therefore     propose that demonstration of persistent cytokine inflammatory markers in this preliminary     study will allow larger studies to proceed.   "
11583|NCT03134287|"     The study aimed to compare the efficacy between nasogastric tube placement using Two-Finger     Method and Reverse Sellick's Maneuver   "
11584|NCT03134274|"     The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick     Analyzer (HBDA) in the context of prenatal care.   "
11585|NCT03134261|"     An improved diagnosis of bone metastases in prostate cancer patients can have a significant     impact on treatment strategy and probably survival as well.      The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT,     choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone     metastases in prostate cancer patients.   "
11586|NCT03134248|"     Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies     Aquacomfort Plus Toric lenses   "
11587|NCT03134235|"     This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention     in the treatment of excess body weight, hypercholesterolemia, and hypertension in the     clinical setting.   "
11588|NCT03134222|"     The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in     females with moderately-to-severely active cutaneous lupus erythematosus (CLE).   "
11589|NCT03134209|"     A single-center, phase IV, randomized, prospective study investigating the efficacy of     various wound closure devices in reducing postoperative wound complications.   "
11592|NCT03134170|"     This study is a randomized controlled cross-over trial, in the form of a proof of concept     study that is designed to evaluate the health outcomes resulting from incorporating a     licensed clinical pharmacist in a health care team to provide case management for diabetic     patients at the Henry J Austin Health Clinic. The study uses a control group design and will     feature both an experimental group and a control group. The control group, of 80 patients,     will receive the standard treatment at the clinic. The experimental group, of 80 patients,     will receive the standard treatment as well as Medication Therapy Management and counseling     from a pharmacist. After one year the patients in the control group can cross-over to the     intervention group and receive care from the pharmacist.   "
11593|NCT03134157|"     Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of     female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate     pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment     of hypercholesterolemia. Statins inhibit proliferation of several cell types including     vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine     tumors characterized by smooth muscle proliferation and excessive deposition of extracellular     matrix. In the present study we aim to evaluate the effect of simvastatin on uterine     leiomyoma development and growth.   "
11615|NCT03133871|"     The aim of this study is to establish whether the use of a special digital camera (SIAscopy)     can provide an accurate and reliable measure of vitiligo which is at least equivalent to the     current gold standard of planimetry. If so, SIAscopy could be used as an objective diagnostic     and prognostic tool in the management of vitiligo patients within dermatology departments and     allow a fair and accurate assessment of new potential treatments.   "
39119|NCT02773602|"     Comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone,     clonidine, or saline (salt water) are added to ropivacaine.   "
11594|NCT03134144|"     Standing work is associated with increased risks of venous and musculoskeletal disorders;     particularly low back pain is commonly reported in prolonged standing work. In manufacturing     work, workstations often do not allow standing aids due to insufficient functional and     spatial conditions. In 2014, the car manufacturer Audi introduced the lower leg exoskeleton     developed by Noonee to their employees working in the factories. This exoskeleton, the     'Chairless Chair' has the advantage that standing work can be performed while technically     sitting on this device. The exoskeleton offers the potential for reduced awkward body     postures, but it is unclear which physiological and biomechanical loads are influenced and     how. This proposal provides a study design evaluating the 'Chairless Chair' in a laboratory     setting, by testing its effectiveness in terms of physiological and biomechanical parameters.     It is suggested to compare different assembly tasks while wearing the exoskeleton, compared     with not wearing the exoskeleton. The 'Chairless Chair' is developed in one size only, which     is why we propose to include participants of different body height, which will enable us to     investigate whether body height influences the effectiveness of wearing the device.   "
11595|NCT03134131|"     The objective of this expanded access program is to provide ONC201 on a single patient     compassionate use basis to eligible adult subjects with recurrent glioma that exhibits a     missense histone H3 mutation .   "
11596|NCT03134118|"     The aim of the phase II Nivothym study is to collect data on activity and toxicity of     nivolumab therapy in patients with thymic carcinoma or type B3 thymoma that previously     received a first platinum-based chemotherapy.   "
11597|NCT03134105|"     The AWARE-Angina study is a cluster randomized trial aimed at evaluating whether routine     provider feedback of patients' angina burden and activity level can improve angina control.     Patients will wear an activity monitor for 6 months, and their providers will be randomized     to receive either monthly feedback or feedback at the end of the study period.   "
11599|NCT03134079|"     This study aims to reduce the amount of sugar in a particular food item and add spices to see     if the food liking of that item rates as high or higher in a post meal survey. Through the     weekly feeding and testing of the menu items we will determine an opinion of the     participants. Results of these surveys will determine whether participants enjoy the reduced     sugar options as much as their full sugar counterparts.   "
11600|NCT03134066|"     There is an urgent need for novel and effective interventions for treatment-resistant     depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive     symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some     preliminary findings to suggest that ketamine may exert its antidepressant effects through     promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate     the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a     pattern separation task) and a battery of other well-established cognitive measures.      This is an assessment-only study, as we will be recruiting subjects to complete an assessment     battery at two time points, before and after receiving ongoing ketamine administrations for     at least four weeks.   "
11602|NCT03134040|"     This study is for physically inactive adults with an active membership at a Greater     Providence Young Men's Christian Association (YMCA).      Participants will receive weekly feedback on their attendance at the YMCA, and will be     enrolled in the study for 1 year.      Participants will be assigned to one of three conditions, to either receive weekly: (i)     monetary incentives, (ii) donations to a charity of their choice, or (iii) feedback only.      In order to continue to receive incentives, participants must maintain an active membership     at the YMCA.   "
11603|NCT03134027|"     The objective of this study is to obtain human blood CD34+ hematopoietic stem/progenitor     cells (HSPCs) to reconstitute a match human immune system in our PDX model. The hypothesis is     that by using matched leukocytes and PDX from the same patient, rejection of the PDX by the     host immune system will not be observed and therefore a preclinical model to study     immunotherapy can be developed to study, understand and improve upon our current therapies.     HSPCs will be collected from bone marrow aspirate obtained from a bone marrow biopsy.   "
11680|NCT03133026|"     Primary Objective: To document state-of- the-art multi-modality management of occluded     biliary SEMS aiming to minimize number of reinterventions while providing symptom relief     without procedure-related serious adverse events.      NOTE: This study will be hypothesis-generating for an anticipated randomized controlled study     (RCT) to compare outcomes of placement of a plastic stent inside the occluded SEMS to     outcomes of the proposed multi-modality approach.   "
11604|NCT03134014|"     75 overweight, habitual 'breakfast-skipping' adolescents will complete the following     long-term, randomized controlled trial. Participants will be randomly assigned to the     following breakfast treatments: 350 kcal high protein breakfasts containing 30 g protein     (primarily from lean beef), 35 g carbohydrates, and 10 g fat; 350 kcal normal protein     breakfasts containing 10 g protein, 55 g carbohydrates, and 10 g fat; or will continue to     skip breakfast. The following outcomes will be assessed during baseline and 4-month     (post-intervention): body weight & body composition; waist circumference; daily food intake;     24-h free-living glycemic control; and pre and post-prandial satiety. In addition, body     weight and free-living breakfast intake (quantity, quality, and type) will also be assessed     at 2-month follow-up   "
11605|NCT03134001|"     Randomized, open label, controlled pilot clinical study comprised hospitalized post operative     patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and     usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional     procedure of nurse providing analgesics.   "
11606|NCT03133988|"     The purpose of the Expanded Access program is to provide margetuximab to patients with breast     cancer and other HER2+ carcinomas who are not otherwise eligible for a MacroGenics sponsored     study and the potential benefit justifies the potential risk of treatment use.   "
11607|NCT03133975|"     This study will be conducted to Assess possible reduction in lipid profile     (LDL-Triglecerides-cholesterol) among pre-menopausal women in vit D group compared to     standard treatment group after 3 months & 6 month of follow up as prophylaxis step for     atherosclerosis.   "
11628|NCT03133702|"     Objectives: to detect the mistakes and deficiencies of the forensic reports which was written     and to detect the injury characteristics of the forensic cases applied to emergency service     of a tertiary hospital.   "
11609|NCT03133949|"     Inflammatory aortitis probably represents a heterogeneous group, and the clinical experience     accumulated over the last ten years, shared by the experts of the subject, is that the     initial clinical, biological or radiological characteristics should make it possible to     differentiate them and dismember the Nosological field.      This will be an essential first step before studying prognosis, risk factors, and therapeutic     options.      The search for diagnostic criteria on a large series, similar to the study of classification     of vascularites of the ACR in 1990, should make it possible to homogenize the diagnoses for     the different teams working on the subject, and to begin work Collaborations, which alone can     improve patient care in the future.   "
11610|NCT03133936|"     The purpose of this study is to evaluate the immune response in recipients of the vaccine.     After participants receive the vaccine, samples of blood will be obtained at several     intervals afterwards. These blood samples will be used to measure the immune response to the     vaccine. Everyone in this study will receive a single dose of flu vaccine, and have blood     samples drawn to measure the immune response over the next 90 days. The investigators will     also ask participants to report any flu like illnesses during the flu season, and if     participants develop a fever or cough, to come in to be tested for flu. This will allow the     investigators to compare the vaccine response between people who got the flu and those who     did not.   "
11611|NCT03133923|"     Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which     occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland     suppurative swelling and pain with fever. The pathological changes and harm caused by mumps     was not only confined to the parotid gland, on the contrary, the social harm caused by     serious complications cannot be ignored. As mumps is a vaccine-preventable infectious     disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13     genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain     of MuV in China was the F genotype. The commonly used vaccine strains represented only a     small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to     type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of     Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A     strain, which was the first separation and preparation of the attenuated mumps viruses in     China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the     cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much     safer to use. The preliminary test results showed that the vaccine possessed good     immunogenicity and good antigenic cross-reactivity. The application of this vaccine will     provide more effective means to prevent and control of mumps epidemic.   "
11612|NCT03133910|"     Mortality benefit has been proven with early antibiotic administration in sepsis.     Antimicrobial therapy should be based on early achievement of effective drug concentrations     by optimizing the pharmacokinetic/pharmacodynamics of individual drugs. Optimal dosing in the     critically ill patient can be challenging with the rapidly changing physiology of sepsis     during the first days of hospitalization with capillary leak, fluid overload, changes in     cardiac output, and alterations renal clearance. Ceftazidime is the preferred beta-lactam for     empiric treatment of sepsis at Lurie Children's Hospital because of its anti-pseudomonal and     anti-enteric bacilli coverage, however, the majority of pharmacokinetic data currently     published in pediatrics does not include Intensive Care Unit (ICU) patients. Adult     pharmacokinetic/pharmacodynamics data suggest that critically ill adults with high level of     illness severity may benefit from continuous or extended infusion beta lactam therapy to     optimize the therapeutic concentration particularly for pathogens that are relatively     resistant to beta-lactams. Understanding the changing pharmacokinetic/pharmacodynamics of     ceftazidime with the progression of illness in the ICU may help determine if current dosing     regimens are adequate to maintain appropriate drug concentrations to optimize antimicrobial     treatment.   "
11646|NCT03133468|"     This study will be conducted to determine the safety and tolerability of single and multiple     oral ascending doses of AJM347 in healthy male participants, and to assess the     pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the     same population. This study will also aim to determine the single and multiple oral ascending     dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to     determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347     and its metabolite in the same population.   "
11613|NCT03133897|"     Current corticosteroid regimens for children hospitalized with asthma typically include a     5-day course of prednisone or prednisolone. However, these medications taste poorly and are     associated with vomiting and poor compliance. Outpatient evidence suggests that a 2-day     course of dexamethasone is as effective as a longer course of prednisone and prednisolone,     and better tolerated. Studies in hospitalized patients are lacking.      The investigators' primary objective is to determine the feasibility of a non-inferiority     trial, comparing 2 days of dexamethasone to 4 days of inpatient prednisone/prednisolone for     inpatient asthma treatment. The investigators also wish to determine the feasibility of 1)     enrolling patients upon admission to hospital, 2) asking patients and/or caregivers to     complete a symptom weekly for 4 weeks, 3) reassessing patients post hospital discharge, 4)     successfully completing phone follow up 4 weeks post hospital discharge, and 5) collecting     health utilization data post hospital discharge.      This study will inform a future multi-site trial comparing prednisone/prednisolone to     dexamethasone in inpatient asthma treatment. It has the potential of improving the delivery     of care in asthma, by improving compliance with a mainstay of treatment. It will also enhance     collaboration within Ontario pediatric hospitals, facilitating knowledge translation and     standardization of care across institutions.   "
11614|NCT03133884|"     Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly     assigned to an experimental group (acupuncture) and a control group (superficial acupuncture)     in a 1:1 ratio. Participants in both groups will receive 20 sessions of acupuncture over 8     weeks, and the same acupoints will be selected in acupuncture treatments.The study cycle will     last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week     follow-up period. And the primary outcome will be measured at the end of 16th week. While,     the secondary outcomes will be measured at the baseline, the 4th,     8th,12th,16th,20th,24th,28th and 32nd week after randomization.After each treatment,     participants will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale     (MASS) to evaluate deqi sensations.   "
11616|NCT03133858|"     Adequate pain therapy is important aspect of perioperative care. Sequelae of inadequate pain     management are patient dissatisfaction, post-operative nausea and vomiting (PONV), inadequate     nutrition, lack of mobilization, and an increased risk for the development of further     complications, such as postoperative delirium (POD). The use of patient-controlled analgesia     (PCA) systems, which allow patients to self-administer analgesics, has improved pain     management. Conventional i.v. PCA and the non-invasive administration of sufentanil     sublingual tablets (ZALVISO®) are available. The aim of this investigation is to study     patient controlled analgesia systems and to examine the incidence of POD, POCD and     postoperative pain.   "
11617|NCT03133845|"     The purpose of this study is to determine if light sedation with spinal anesthesia reduces     the incidence of delirium compared to receiving general anesthesia during spinal surgery in     older adults.   "
11618|NCT03133832|"     Schistosomiasis remains an important parasitic disease in the tropics, special in Africa     including Zanzibar. The WHO-recommended strategy to eliminate schistosomiasis involves     large-scale treatment of affected populations through periodic, targeted treatment of     school-children with praziquantel. Donated praziquantel is the key to achieving elimination.     The increase in the number of treatments is attributable to many factors, including improved     availability of donated praziquantel, essentially from Merck; new countries starting to     implement large-scale schistosomiasis control programmes; geographical scale-up of treatment     within countries; and improved reporting to WHO. The global target set by WHO in the Roadmap     on neglected tropical diseases is to attain at least 75% coverage of preventive chemotherapy     in pre-school and school-age children by 2020. Experience from China demonstrates that     preventive chemotherapy (that is, large scale treatment without individual diagnosis) with     high coverage can significantly impact indices of infection and reduce transmission. The     praziquantel made in China has been used from 1990s, and have effectively activity against S.     haematobium, special the good economic benefits.      The project will propose to conduct an open-label, randomized trial to evaluate the     comparative efficacy of Chinese-made Praziquantel versus WHO Praziquantel in the treatment of     200 people infected with S. haematobium in Pemba island Zanzibar. To do this the     investigators will screen about 4000 people by examination of urine for schistosome eggs.     Eligible participants will be randomized to receive a single dose of Chinese-made and WHO     Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg     reduction. The study may provide an alternative drug treatment for S. haematobium.   "
11619|NCT03133819|"     Peripheral neuropathy is just assessed by determination of Vibration sensation, pressure     sensation, superficial pain or temperature. The most commonly used technique for diagnosis of     peripheral neuropathy is nervous conduction (NC) and electromyography (EMG). But EMG/NC is     bothersome and techniques using electric currents to measure NC and needles to study muscle     innervations are uncomfortable.      Quantitative NeuroSensory Testing (QST) is essential in the evaluation of small-caliber     A-delta and C-fibers, the primary transmitters of thermal and pain sensation. QST can     demonstrate neurosensory abnormalities when it is non-invasive test, selective to small     fibers despite negative EMG/NCV finding.      The investigators predict QST can be used for the early diagnosis and follow-up of     small-fiber neuropathy in diabetes patients. The investigators also predict the early     evaluation of diabetes neuropathy with QST can reduce the diabetes patient progress to     advance stage of DM foot or limb amputation.   "
11620|NCT03133806|"     The purpose of the study is to demonstrate the safety and the rate of closure of the     Ultrasept Left Atrial Appendage (LAA) Closure System for the percutaneous occlusion of the     left atrial appendage in patients with non-valvular atrial fibrillation.   "
11621|NCT03133793|"     The purpose of this study is to compare the clinical benefits of CoQ10 and D-ribose taken by     patients who have diastolic heart failure, or heart failure with preserved ejection fraction     (HFpEF).   "
11622|NCT03133780|"     Patients during spinal anesthesia should be sedated.   "
11623|NCT03133767|"     Administration of intravascular (IV) fluid is the most common emergency department (ED)     procedure. IV fluids are integral to increasing effective blood volume and ensuring organ     perfusion in patients with volume depletion and dehydration. There are many options of IV     fluids providers can use when treating ED patients. Surveys show physicians do not cite an     evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to     be influenced by type and location of practice. A gap exists in the current literature, as     there is no evidence for the optimal IV fluid choice for the ED patient requiring IV fluid     before discharge.      Normal saline (NS) is commonly used as an IV fluid replacement in ED patients. However, NS     has been associated with increased risk of acidosis and acute kidney injury. This study will     use a novel approach of a patient-centered outcome in a non-critically ill population to     ascertain the optimal IV fluid for patient quality of recovery. The results of this study     will inform provider's IV fluid decisions between NS and LR. More importantly, the results of     this study will have the power to improve patient's quality of recovery following IV fluid     administration and subsequent ED discharge.      ED patients will be recruited, and participants will be randomized to receive one of two IV     solutions (Lactated ringer's or normal saline). Participants will answer a survey before and     after the intervention to assess their quality of recovery. The post-survey will be     administered by phone after ED discharge. Participants will also be contacted by text message     one week following their ED visit to gather information on their healthcare utilization.   "
11624|NCT03133754|"     This study aims to compared the effects in driving pressure of an open-lung strategy with a     positive end-expiratory pressure (PEEP) titrated to best driving pressure (DP) after a RM     versus the recommended protective PEEP of 5 cmH2O without a recruitment manuever in non-obese     patients undergoing cardiac surgery.   "
11625|NCT03133741|"     Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using     GIP receptor antagonisation.   "
11626|NCT03133728|"     The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic     assay) on uptake of HIV testing among HIV-exposed infants and young children, and health     outcomes for HIV-infected infants and young children in Zambia. It will also assess the     feasibility of field implementation of this novel diagnostic tool and its acceptability among     HIV-infected mothers and frontline health workers.   "
11627|NCT03133715|"     Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair     surgery.   "
11631|NCT03133663|"     The purpose of this study is to determine whether using electrocardiograms (ECGs) during     resuscitation of preterm infants (less than 31 weeks gestation) will decrease the amount of     time it takes from birth for heart rate (HR) to be above 100 beats per minute and oxygen     saturations to be in the goal range, in other words to stabilize the infant. A few studies     have been conducted which showed that ECGs are faster at detecting HR than pulse oximetry     (PO). Sample sizes, however, have been small and only few extremely low birthweight infants     have been included. It is unclear if use of ECG in these tiny preterm infants in addition to     traditional techniques to determine HR will be beneficial and impact resuscitation and     outcomes. The investigators propose a study where infants will be randomized to either using     ECG in addition to PO ± auscultation versus PO ± auscultation only to assess HR during     neonatal resuscitation. The investigators hypothesize that the group of infants randomized to     ECG will be able to stabilize faster, i.e. achieve HR > 100 beats per minute and oxygen     saturation in goal range faster.   "
11632|NCT03133650|"     The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to     treat obstruction from esophageal cancer that can be safely given.   "
11633|NCT03133637|"     Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have     jaundice during the first postnatal week. The effect of ceftriaxone on jaundice has not been     investigated in well designed studies   "
11634|NCT03133624|"     This is a registry study on a multidimensional prediction model for rupture risk of     unruptured intracranial aneurysms in China.   "
11635|NCT03133611|"     Speech is an important indicator of motor function and movement coordination and can be     extremely sensitive to involvement in the course of neurologic diseases. The aim of this     project is to discover for the first time using simple speech recording and high end pattern     analysis preclinical stages of disabling central nervous system disorders including     Parkinson's disease and other alpha-synucleinopathies in at high risk patients with REM     sleep behavior disorder and thus provide one essential prerequisite for trials on REM sleep     behavior disorder with preventive therapy.   "
11647|NCT03133455|"     Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population,     Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease.     This dichotomous reasoning does not lead to a better understanding and does not allow the use     or development of new psychological tools of care.      The issue of the proximity between FM and depression highlighted by some authors and the     presence of anxious comorbidities may arise at a different level, that of the transdiagnostic     approach. Rumination is one of these transdiagnostic processes that are the subject of recent     studies and one of the dimensions of which (abstract analytical rumination) is at work in     depression and a number of psychopathologies. The investigator therefore wishes to explore     the process of rumination and its abstract analytical dimension in FM and to explore its link     with the depressive and anxious manifestations frequently associated with this disorder.   "
12393|NCT03123406|"     1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL          in hemodialysis subjects with mild, moderate and severe SHPT;        2. To explore the impact of Cinacalcet HCL using on the combined use of drugs;        3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in          real-world period from 33rd to 52nd week.   "
11636|NCT03133598|"     Un-ruptured intracranial aneurysm is a complex disease that seriously affects human life and     health. At present, the treatment of intracranial aneurysm is divided into interventional     treatment and craniotomy clipping, the two treatment methods are different in the     intervention effect of aneurysm, for example, the complications of interventional therapy are     lower than craniotomy clipping, but the long-term patency rate is lower than craniotomy     clipping, and there is no standard of treatment in different parts of aneurysm in our     country, the choice of intervention measures of un-ruptured aneurysm is different in     different clinical centers; on the other hand, there are serious problems in the treatment of     aneurysms, because without the relevant guidelines of diagnosis and treatment of intracranial     aneurysms, different clinical centers will cause excessive treatment of un-ruptured     aneurysms, not only bring unreasonable utilization of medical resources, but also cause the     subject's life and property to be threatened.      The patients with un-ruptured intracranial aneurysm(n=1500) were included in prospective     cohort study, after clipping and intervention operation, setting fixed time for postoperative     follow-up, the clinical data and image data were recorded, the safety, efficacy and economic     benefits of interventional treatment and craniotomy clipping were compared, providing     strategies for the standardized treatment of un-ruptured intracranial aneurysms.   "
11637|NCT03133585|"     To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.      The primary variable is to evaluate the degree of satisfaction of patients in terms of     leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.   "
11638|NCT03133572|"     Mortality rates from birth asphyxia in low-income countries remain very high. Face mask     ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is     mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless     supraglottic airway which is easy to insert and provides an efficient seal that prevents air     leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can     be trained in a short time to use this method. A pilot study in Uganda has demonstrated that     midwives can safely perform resuscitation of newborn with the i-gel.      OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to     face-mask ventilation during neonatal resuscitation can reduce mortality at 7 days, morbidity     in neonatal encephalopathy (NE) in asphyxiated neonates.      STUDY DESIGN, SETTING AND POPULATION A multi-centre randomized clinical trial will be     conducted at Central Hospital, Beira, Mozambique and at Mulago Hospital, Kampala, Uganda,     among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the     labour ward performing resuscitation will receive training according to the HBB curriculum     with a special module for training on supraglottic airway insertion. Resuscitation will be     performed according to international guidelines.      UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not     only would reduce mortality, but also the burden of neurological damage in survivors.   "
11656|NCT03133338|"     The investigators aimed to evaluate the effect of early pelvic binder use in emergency     management of suspected pelvic trauma, compared with the conventional stepwise approach.   "
11643|NCT03133507|"     This study tested the effects of emotion regulation strategies (reappraisal, reassurance, and     empathy) on pain responses in children with cancer. Children with cancer were randomly     assigned to one emotion regulation strategy during an experimental pain task (the cold     pressor task [CPT]). During the CPT, children rated their pain and provided saliva samples     immediately before, after, and then 15 minutes after the CPT. This study examined the     influence of emotion regulation on self-reported pain and physiological activity assessed     through saliva samples.   "
11644|NCT03133494|"     The investigator found out that as such the base line carbon dioxide (CO2) level is higher in     smokers as compared to non-smokers even before creation of pneumoperitoneum, which is due to     the compromised lung function following chronic smoking. This condition gets aggravated after     creation of pneumoperitoneum which is very much evident from the serial arterial blood gas     analysis. The level of CO2 remains elevated even after deflation of the pneumoperitoneum.     Hence one has to be very much vigilant not only during intra-operative period but also in     post-operative care unit. Hence serial ABG monitoring should be included as a part of the     protocol especially in laparoscopic surgeries.   "
11645|NCT03133481|"     Peripheral nerve blocks catheters of the femoral nerve have long been used for perioperative     analgesia in total knee arthroplasty (TKA). These blocks provide effective analgesia and     patient satisfaction for surgical pain relief. However, one of the main drawbacks to the     femoral nerve block (FNB) is a denser motor block of the quadriceps muscle that can delay     aggressive physical therapy and subsequent recovery from surgery. (1) Recently, there has     been increasing interest in performing adductor canal blocks (ACB) with the aim of less motor     blockade while providing commensurate analgesia compared to the FNB. (1,2) Current     investigative reports have provided only preliminary data, and there is potential to change     the standard of care for TKA as more data mounts in favor of ACBs. The goal of this study is     to verify the analgesic equivalence of the two blocks, compare patient satisfaction, surgeon     satisfaction, and physical therapy grading between the two blocks. Potentially, this would     change the standard of care for TKA patients at this institution.   "
11681|NCT03133013|"     The purpose of this study is to test the ability of a brainwave measurement device     (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data     from individuals with untreated depression and healthy participants will be collected and     analyzed. The ability to obtain brainwave data from individuals in their homes while they're     sleeping would represent a significant advance in depression research.   "
11648|NCT03133442|"     Vestibular stimulation might be beneficial for sleep. Previous research demonstrated that     lateral rocking movements can facilitate the transition from wake to sleep during an     afternoon nap. However, the relationship between rocking movements and sleep is poorly     understood to date. Furthermore, studies looking at the effects of rocking on sleep have not     yet been performed in an elderly population. Due to age related changes in sleep, people     often experience a decrease in sleep efficiency and sleep quality later in life. Therefore,     it is particularly this population that could benefit from a possible enhancement in sleep     efficiency and sleep quality. In order to assess the effect of vestibular stimulation on     sleep and sleep-dependant memory, measurements of two nights with stimulation will be     compared to two baseline nights. The primary outcomes are changes in sleep onset, sleep     architecture and power density spectra of the EEG due to vestibular stimulation. Secondary     endpoints are sleep dependent changes in memory, the proximal-distal temperature gradient,     cardiorespiratory variables and dream content.   "
11649|NCT03133429|"     The aim of the study is to confirm, whether the MER® stent can be used, without limitations,     for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients     will undergo the procedure of the common or internal carotid artery stenting using MER® with     proximal or distal neuroprotection.   "
11650|NCT03133416|"     The investigators aim to investigate whether combination of PRP injection with physiotherapy     program could produce superior effect than either treatment alone.   "
11651|NCT03133403|"     The purpose of this study is to assess the efficacy of autologous PBSCT versus FDA approved     standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod,     or tecfidera) for inflammatory MS failing alternate approved therapy.      Disease progression, defined as a 1-point increase in the Expanded Disability Status scale     (EDSS) on consecutive evaluations at least 6 months apart and not due to a non-MS disease     process. Patients will be followed for 5 years after randomization.   "
11652|NCT03133390|"     This is a randomized phase II study assessing the activity of bevacizumab combined with     atezolizumab compared to atezolizumab alone in metastatic urothelial carcinoma subjects who     are ineligible for cisplatin-based therapy. Eligible subjects will be randomized to receive     treatment with either (Arm A) atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg     IV every 21 days versus (Arm B) atezolizumab 1200 mg (flat dose) IV monotherapy every 21     days. Cross-sectional imaging will be performed every 9 weeks on therapy for the first 12     months and then every 12 weeks thereafter to assess for response.   "
11653|NCT03133377|"     The aim of this study is to evaluate the effect of early activity and mobilisation during     prolonged IMV on the composite outcome days alive and at home to day 180. The effect of the     intervention on mortality, physical, cognitive and Psychological function at 180 days, as     well as cost-effectiveness of the intervention, will also be evaluated. The study will also     explore process of care measures and baseline physiology and ICU mobility outcomes.      The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and     mobilisation increases the number of days alive and at home to day 180 when compared with     standard care.   "
11654|NCT03133364|"     Meals-on wheels may play a major role in contributing to better nourishment and quality of     life in older people, thus delaying costly hospitalisation. Still, dwelling, old adults who     receive meals-on-wheels are a population at risk of undernutrition leading to a decreased     quality of life and functional status.      Hypothesis Offering nutritious ELDORADO meals as meals-on-wheels to nursing home residents in     3 months is an effective way to increase quality of life and functional abilities.      Aim To improve quality of life and functional abilities in nursing home residents by offering     nutritious ELDORADO meals.   "
11655|NCT03133351|"     This study is intended to define the PCM normal laboratory range.   "
43042|NCT02722278|"     A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral     Testosterone Undecanoate (TU) in Hypogonadal Men   "
11659|NCT03133299|"     Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused     by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is     about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA     stems from the fact that the disease is glucocorticoid-sensitive and early treatment can     prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been     suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and     decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role     of vitamin D in treating ABPA.   "
11660|NCT03133286|"     Collect blood samples and associated clinical data prior to, during, and post radiation     treatment.   "
11675|NCT03133091|"     Randomized single blind trial based on comparing the way the local anesthetic is dosificated     during labour. The pain control is evaluated and compared with both dosage techniques (PCEA     vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in     pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor     block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o     cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and     secondary effects of local anesthetic.   "
11676|NCT03133078|"     The purpose of this study will be to determine the effects of a 2-minute single limb lateral     step-down fatigue test versus a 30 second side hop test on single limb forward hop distance.   "
11677|NCT03133065|"     The study aimed to present our experience in treating recurrent HCV genotype 4 infection post     living donor liver transplantation (LDLT) since introduction of the second generation direct     acting antiviral drugs (DAAs) in Egypt.   "
11678|NCT03133052|"     This study evaluates the efficacy and mechanism of internet-based cognitive control training     on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Half     of participants will receive adaptive internet-based cognitive control training program,     while the other half will receive a fixed, primary difficulty level task.   "
11661|NCT03133273|"     Currently, chemotherapies are empirically administered to patients treated for colorectal     cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the     largest number (consensus treatment), the decision-making process being weighted by patient's     intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral     heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates     observed for available chemotherapies. Functional sensitivity tests offer the possibility to     adapt the treatment to each patient: they are based on an ex vivo study of the responses of     the tumor cells (survival / death) to the different molecules / therapeutic combinations     (chemotherapy or targeted therapy) likely to be administered to the patient. This response,     translated into a tumor-specific sensitivity profile, can be used by the clinicians to     determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy     from the first line and reducing the deleterious side effects associated with multiple drug     cycles, the sensitivity test transforms the consensus approach into personalized medicine,     providing patients with improved progression free survival (PFS) associated with an     improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in     vitro diagnostic medical device that has already demonstrated the ability to predict     chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of     success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered     according to the consensus method). The hypothesis that patients treated with a metastatic     CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates,     PFS and quality of life than patients treated according to usual practice, with optimization     of the costs of care. To our knowledge, this is the only fully standardized test available,     where each step and reagents of the procedure are mastered. The reliability of the procedure     makes it possible to render a personalized result for each patient in 97% of the cases. In     addition, the analysis is specifically centered on tumor cells using a method using fully     defined, developed and validated media and reagents for each cancer, including CRC. The     method of revealing the effect of the therapies identifies the proportion of dead cells in     each condition, whatever their physiological state (proliferation / quiescence), by     determining the percentage of living and killed cells, thus ensuring high sensitivity   "
11662|NCT03133260|"     Major adverse cardiovascular events are the leading cause of perioperative morbimortality in     non-cardiac surgery. Perioperative myocardial infarction is usually asymptomatic, with a     mortality around 10-12%.      Myocardial Injury in Noncardiac Surgery (MINS), is defined as a myocardial injury that     provokes a troponin increase due to myocardial ischemia. MINS is a predictor of     morbimortality at short term and at long term.      The aim of the study is to improve the diagnosis of myocardial injury after non cardiac     surgery in high-risk patients, improve its treatment in case of MINS and establish prevention     strategies.   "
11663|NCT03133247|"     In many types of human tumors, PD-L1 is highly expressed. Such high expression has often been     associated with poor prognosis in cancer patients. SHR-1316 is a humanized IgG4 monoclonal     antibody that binds specifically to human PD-L1.   "
11664|NCT03133234|"     To assess the effectiveness and safety of osimertinib treatment in a real world setting.   "
11665|NCT03133221|"     This is a pilot study to learn how safe and how effective the study drug Zydelig works, after     autologous stem cell transplant as a maintenance therapy in patients with indolent or     transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL).   "
11666|NCT03133208|"     Sepsis associated encephalopathy (SAE) is a poorly understood acute cerebral dysfunction that     frequently appears in the setting of sepsis induced systemic inflammation. In fact, altered     mentation is recognized as an independent predictor of death and poor outcomes in patients     with sepsis. SAE may be manifested by a number of symptoms characterized by a change in     baseline behavior, attention, alertness, cognition, or executive functioning. It occurs in     the absence of direct Central Nervous System (CNS) infection, and the exact pathophysiology     is of SAE is unknown, but theoretically seems to encompass a constellation of mechanisms such     as impairment of the blood brain barrier (BBB), endothelial dysfunction, alteration in     cerebral blood flow and neurotransmission, circulating inflammatory mediators, cellular     hypoxia, and metabolic disturbances, that ultimately result in neuronal dysfunction and cell     death. SAE is characterized by an altered mental status (AMS) that ranges from delirium to     coma, and can lead to long-term cognitive impairment. SAE may appear early in the course of     sepsis, and is often underestimated as an independent factor of mortality, yet the     pathophysiology of SAE remains unknown, and there is a lack of specific investigations     available to clinicians. Studies have evaluated biomarkers as prognostic tools. The     Investigator propose to measure neuron specific enolase (NSE), S-100B, glial fibrillary     acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), Tau protein, Copeptin,     spectrin breakdown products (SBDP 145, SBDP150), αII-spectrin N-terminal fragment (SNTF),     neurofilament light and heavy chains (NF-L, NF-H), myelin basic protein (MBP), secretoneurin     (SN), and other peptide levels in the serum of sepsis patients who develop altered mental     status, to evaluate the kinetics of said biomarkers for 72 hours. The Investigator will     monitor the course of the patients' hospitalization to determine whether there are biomarker     correlates with survival and outcomes, including neurologic impairment. Finally, this     investigation may provide a mechanistic pathway that defines the development of AMS in septic     patients.   "
11667|NCT03133195|"     Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to     determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric     fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by     radiographic and clinical outcomes.   "
11673|NCT03133117|"     The main objective of this research is to study the cognitive and cerebral mechanisms of the     integration of central and peripheral visual information during normal and pathological aging     (ophthalmological patients with AMD and glaucoma) through fMRI studies. To assess the effect     of normal aging, research will be conducted on a group of young participants with normal     vision and a group of elderly participants with normal vision. Each participant will be     assessed once during an MRI (during which the brain activity and behavioral performance will     be measured). In order to evaluate the effect of pathological aging, research will be     conducted on AMD patients, glaucomatous patients, and age-matched controls (normal vision),     evaluated only once during an MRI examination.   "
11674|NCT03133104|"     This study will review records of women who broke their water early who received a repeat     course of antenatal steroids.   "
11679|NCT03133039|"     The investigators sought to determine whether bioabsorbable cannulated screws could perform     as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in     anatomical models and clinical series of the foot.   "
11682|NCT03133000|"     Prospective non-randomized observational register study of all elective symptomatic     incisional hernias operated on in the Hernia Center of Reference of Gross Sand Hospital using     the novel endoscopic assisted Mini- or Less-Open Sublay technique. The data of all patients     were prospectively documented in the German Hernia Registry Herniamed. The novel     MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for     the treatment of primary and secondary incisional hernias.   "
11683|NCT03132987|"     Quantify differences in quadriceps function and gait biomechanics in individuals within 2     years of ACL reconstruction compared to a healthy comparison group and establish the     feasibility of conducting a progressive strengthening program to improve clinical and     patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction   "
11684|NCT03132974|"     The Purpose of this trial is to investigate the efficacy and safety of herbal medicine with     manipulation therapy on Korean Patients with Chronic Low Back Pain   "
11685|NCT03132961|"     Persons exposed to infrasound - frequencies below 20 Hz - describe a variety of troubling     audiovestibular symptoms, but the underlying mechanisms are not understood. Recent animal     studies, however, provide evidence that short-term exposure to low frequency sound induces     transient endolymphatic hydrops. The existence of this effect has not been studied in humans.     The long-term objective of this research is to identify a possible mechanism to describe the     effects of infrasound on the human inner ear. The central hypothesis of the proposed study is     that short-term infrasound exposure induces transient endolymphatic hydrops in humans. This     will be tested by performing electrophysiologic tests indicative of endolymphatic hydrops     among normal hearing individuals before and immediately after a period of infrasound     exposure. Recordings of infrasound generated by wind turbines in the field have been     established and calibrated by this team of engineers, otologist, and hearing and balance     scientists. An infrasound generator reproduces the acoustic signature based on these field     recordings. Aim 1: Determine the effect of infrasound on the summating potential to action     potential (SP/AP) ratio on electrocochleography (ECoG). Hypothesis 1: Infrasound exposure     will cause a reversible elevation of the SP/AP ratio. Aim 2: Determine the effect of     infrasound on the threshold response curves of ocular and cervical vestibular evoked myogenic     potentials. (oVEMP and cVEMP). Hypothesis 2: Infrasound exposure will cause elevation of the     oVEMP and cVEMP thresholds at the frequency of best response. Successful completion of the     aims will provide evidence for a possible mechanism of the effect of infrasound on the inner     ear. This understanding will benefit individuals exposed to environmental infrasound and     those in regulatory, research, and advocacy roles when crafting interventions and future     policy.   "
11686|NCT03132948|"     The purpose of the study is to evaluate the impact of exercise on physical activity levels     and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance     chemotherapy.   "
11687|NCT03132935|"     Telemedically supported paramedic care of acute coronary syndromes was compared to a     historical control period of solely conventional on-scene physician care. Quality outcomes     based on current guidelines were researched als well as time requirements in both groups.   "
11688|NCT03132922|"     This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in     subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma,     head and neck, ovarian, non-small cell lung, esophageal, or gastric tumor has the MAGE-A4     protein expressed. This study will take a subject's T cells and give them a T cell receptor     protein that recognizes and attacks the tumors.   "
11689|NCT03132909|"     The sick doctor is a patient apart. His right of prescription and his knowledge of semiology     easily lead him to self-medication. Several factors linked to his profession may also lead to     a delay in care: overworking with schedules that are not compatible to organize follow-up,     poor access to prevention or occupational medicine for liberal doctors but also modesty And     ashamed of being sick (and especially unfit to heal). Specialized centers and specific     training courses concerning burnout, addictions and psychiatric pathologies of doctors are     currently emerging.      To look after a colleague also seems to imply certain specificities like the sharing of     knowledge or the medical vocabulary. The physician-patient relationship may seem easier, but     it can also lead to confusion of roles and create ambiguity. In this case, the doctor may     feel too close to the doctor-patient to maintain his objectivity and to treat him properly.     In the same way, the relationship of trust can be altered by sharing medical knowledge,     communication techniques or confidence building which can thus lose their effectiveness.      This physician-caregiver relationship has already been the subject of some qualitative     research demonstrating the difficulty from the point of view of the treated. The feelings and     attitudes of the doctor caring for his colleague remains a field very little studied. The     research hypothesis is that there are specificities to this relationship.   "
11690|NCT03132896|"     ROSETTA is a multi-centre study evaluating the time course of diaphragm thickness and     function following exposure to neuromuscular blockade or control in patients with acute     respiratory distress. ROSETTA is an ancillary study to the Re-evaluation of Systemic Early     Neuromuscular Blockade (ROSE) trial (NCT02509078). It is designed to (1) test the feasibility     of a multi-center evaluation of the diaphragm structure and function by ultrasound during     mechanical ventilation and (2) determine whether neuromuscular blockade accelerates atrophy     and dysfunction of the diaphragm in patients with acute respiratory distress syndrome (ARDS).   "
11698|NCT03132792|"     This study will investigate the safety and tolerability of AFPᶜ³³²T cell therapy in subjects     who have the appropriate HLA-A2 tissue marker, whose liver tumor has the AFP protein and     whose noncancerous liver tissue has very little AFP protein. This study will take a subject's     T cells and give them a T cell receptor protein that recognizes and attacks the tumors.   "
11699|NCT03132779|"     Evaluating the effect of intralipid on the natural killer cells   "
11691|NCT03132883|"     Transbronchial puncture is a technique known for many years with the first description found     in 1949 by Shieppati. Subsequently, this technique allowing an exploration of the mediastinal     lymph nodes became widespread with the work of Wang in 1983. However, the need to have exact     knowledge of the different puncture sites in order to obtain maximum profitability with this     examination in particular In staging and diagnosis in bronchopulmonary cancers (CBP) explains     a significant difference in profitability between operators based on their experience. It was     not until 1990 that Germans coupled the technique of radial ultrasound with that of     bronchoscopy by introducing a balloon catheter inflated with a liquid allowing the best     transmission of ultrasound. It is the German team of Herth who developed this technique in     1999 under the name of bronchial echo-endoscopy (EBUS). The association of echo-endoscopy     before transbronchial punctures significantly improves the performance of the examination. In     2004, Yasufusu shows the interest of the real-time visualization of the lymph nodes for the     marking as well as the punctures. Therefore, the indications for bronchial echoendoscopies     with transbronchial needle puncture (EBUS-PTBA) are precisely defined in the nodal staging of     CBP with good profitability and a reduction in surgical mediastinoscopy. Then, over time,     there is an extension of indications with the diagnosis of Non-Small Cell Lung     Broncho-Pulmonary Cancers (NSCLC) or Small Cell Broncho-Pulmonary Cancers (CBPC), the     diagnosis of ganglion metastases of extra-thoracic primary tumors , Diagnosis of sarcoidosis     or other more anecdotal uses (tuberculosis, lymphoma).      Two Picard centers were among the first in France to be equipped with echoendoscopes (2007     for the CH of Saint Quentin and 2008 for the CHU of Amiens). This allows our two centers to     have a fairly consistent retreat on the technique since its implantation in France. While     many studies are concerned with one or other indication in isolation, there is no study to     the best of our knowledge relating the evolution over time of the respective share of each of     these indications in daily practice . Given the current multiplication of potential     indications for EBUS-PTBA, it seems interesting to analyze the place of these new indications     in the daily activity of endoscopic centers equipped with an echo-endoscope. The main     objective is to evaluate the respective share of each indication over time over the study     period. Secondary objectives are the evaluation of the diagnostic performance of EBUS-PTBA,     the evaluation of the abusively carried-out EBUS-PTBA (examination carried out for purely     diagnostic purposes, whereas conventional bronchial fibroscopy Diagnosis of certainty) and     evaluation of concordance between EBUS-PTBA and surgery in CBP staging indications.   "
11692|NCT03132870|"     The diagnosis of nodules and peripheral lung masses (lesions not accessible in classical     bronchial endoscopy) is a challenge for the pulmonologist especially when these lesions are     not accessible to the transparietal aspirate under scanner. The overall sensitivity of     flexible fibroscopy for peripheral lesions is 69% (bronchial brushing, transbronchial     biopsies, bronchoalveolar lavage and blind trans-mucosal aspiration). This sensitivity varies     from 33% when the lesion is less than 2 cm, to 62% when it is greater than 2 cm. The puncture     under scan of these lesions remains the gold standard. In the meta-analysis of Schreiber G et     al., The diagnostic sensitivity of transparietal aspirate for peripheral lung lesions is 90%.     On the other hand, the complication rate of this technique is not negligible, with in the     study of Boskovic et al, a pneumothorax rate varying from 8 to 64%. In the literature, the     only risk factor actually found is the existence of emphysema. However, thoracic drainage is     rarely necessary.      Bronchial echo-endoscopy using a radial mini-probe was developed in 1992 by Thomas Hürter and     Peter Hanrath to produce ultrasound guided specimens of these peripheral lung lesions. In the     meta-analysis of Steinfort et al., The overall sensitivity of this mini-probe technique is     73% for the histological diagnosis. From the same author, a randomized trial compared the     diagnostic sensitivity of transparietal aspirate undergoing ultrasound-guided transbronchial     biopsy with a radial mini-probe: this was 93.3% versus 87.5% with no significant difference     (p = 1 ), Whereas post-procedure complications are less frequent in the ultrasound procedure     (27% versus 3%, p = 0.03). Steinfort also showed that the economic cost of bronchial     echo-endoscopy by radial mini-probe and transthoracic puncture under CT was similar both to     the success or failure of the first procedure requiring further investigations .     Mini-probe-guided specimens are therefore an efficient diagnostic alternative to obtain a     histological diagnosis of these peripheral lung lesions   "
11693|NCT03132857|"     In 2010, the French population over 75 years of age was 9%; It will be 13% in 2030 and 19% in     2050 according to estimates. The incidence of falls is high in the elderly population, with     at least one fall per year for one-third of the over-65s and for half of the over-80s. These     data are consistent with the international medical literature, particularly in Japan, the     United States and France, with a high rate of recurrence from the first fall. Falling is a     complex phenomenon that is of great importance in terms of morbidity and mortality since it     can be followed by serious complications: failure to recover, recurrences, trauma (fractures,     hematomas, wounds), complications of decubitus and ulcers, Immobilization, loss of autonomy,     hospitalization, institutionalization, psychological complications (post-fall syndrome,     depressive syndrome), death.      Fall risk factors are well known and described and relayed by learned societies of geriatrics     and medical literature. In addition, HAS reported on this issue in 2009.      The French Society of Geriatrics and Gerontology (SFGG) defines fragility as a clinical     syndrome that reflects a decrease in reserve physiological capacities that alters the coping     mechanisms of stress. Its clinical expression is modulated by comorbidities and     psychological, social, economic and behavioral factors. Frailty syndrome is a risk marker for     mortality and pejorative events, including disability, falls, hospitalization and     institutionalization. The fall and its complications are closely related to the fragility     syndrome. The very fragile patient must take an active part in his own care. He is the first     advocate of fall prevention.      On the other hand medical desertification and the low number of geriatricians makes this     implication problematic even more so if the person is isolated or has cognitive impairment.     Nevertheless, it is important to make the patient actor of his own prevention. This is the     first study to describe the knowledge of older adults about their own risk of falling.   "
11694|NCT03132844|"     In France, the vaccination coverage of seniors is clearly deficient. It seems to be a     cultural specificity, dating back more than 100 years, and which does not exist in     Scandinavia, nor in much of the Anglo-Saxon world. Only influenza vaccination is a success     for seniors. The high public health council sets the objective of immunization coverage in     patients over 65 years of age to 80% whether or not the patient is benefiting from an     exonerative ALD. The data collections carried out with the various pension funds objective     have a lower immunization coverage with a rate ranging from 48.8 to 64%. Thus any medical     consultation should be an opportunity to update the vaccination schedule of adults and the     elderly.   "
11695|NCT03132831|"     Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that     arouses the attention of orthopedic surgeons in order to return home early through the fast     recovery protocols but this goal is also wanted in public health for the sake of overall     decline health spending in public costs.      Reducing the LOS after primary hip arthroplasty and knee is studied through many publications     that found an LOS influenced by the own medical factors of patients (ref) However, no study     to our knowledge research the influence of the operative day and the LOS.      For historical reasons, the organization of care is modified on the weekend (Saturday and     Sunday) in particular by reducing the caregiver and also the lack of physical therapist to     make the early postoperative get up (D0 or D1).      The hypothesis is that a patient operated the friday did not have the same care the first 48     hours that a patient who had surgery at the beggening of the week and that his recovery was     therefore extended.      The investigator can also suppose that LOS was shorter for patients returning home for those     who were transferred to a rehabilitation center or other structure.      The results will be adjusted according to the literature data on the age more than 80 years,     sex, diabetes, cardiovascular diseases, respiratory diseases.   "
11696|NCT03132818|"     Sexual disorders associated with medical aid for procreation have already been demonstrated     in several studies. However, few of them are interested in the problem of patients in charge     of donating gametes, and if studied, it is often restricted to donating sperm to a small     number of patients. For this reason, it would be interesting to study the impact of the     intake and in charge and the treatments of the Medical Aid to the Procreation on this     population of patients (including the patients treated in donation of sperm but also Those     supported in oocyte donation)   "
11712|NCT03132610|"     A multicenter,randomized,single-blind, placebo-controlled,phase 4 clinical trial to evaluate     the efficacy and safety of andrographolide sulfonate in patients with acute exacerbation of     chronic bronchitis   "
11726|NCT03132428|"     This is a multicenter, prospectively defined, observational registry study evaluating the use     of inhaled nitric oxide (INOMAX) in 84 Premature (P) neonates (at least 27 weeks but less     than 34 weeks of gestational age [GA]) and 84 Term-Near-Term (TNT) neonates (at least 34     weeks to no more than 40 weeks of GA), with Pulmonary Hypertension (PH). The 2 groups will     have a similar number of subjects by severity (mild, moderate, and, severe) and evaluated for     response to INOMAX during a treatment period of up to 96 hours ± 12 hours and a safety     follow-up through 7 days (for a total of up to 11 days) or to hospital discharge, whichever     comes first.   "
11729|NCT03132389|"     In this study the investigators seek to register the prevalence of sexually transmitted     infections (STI) among people attending the Sexual Assault Centre in Oslo, Norway. The main     aim of this study is to gather representative data on STIs after sexual assaults.     Consequently, if the attendance for medical follow up turns out to be good/sufficient,     prophylactic (antibiotic) treatment can potentially be omitted.   "
11700|NCT03132766|"     This study will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders'     Resilience intervention (ER), Case Management (CM) and the combination of these approaches on     reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are     identified by a surveillance system as having recent suicide ideation or behaviors or binge     substance use. This five-year study tests a sequence of novel preventive strategies that     American Indian (AI) tribes can use to sustainably reduce the burden of AI youth suicide and     promote resilience. The study will evaluate the effectiveness of task-shifting the     administration of interventions to culturally embedded paraprofessionals. The Johns Hopkins     Center for American Indian Health (CAIH) will provide research oversight and the White     Mountain Apache Tribe (WMAT) will be the primary study site. Navajo Nation (NN) will     participate as a secondary site in years 4-5. The study investigators hypothesize that: a)     New Hope vs. Case Management alone will significantly reduce participant suicidal ideation;     b) Elders Resilience vs. Case Management alone will significantly improve participant     resilience; c) New Hope followed by Elders Resilience will have the strongest effects on     suicidal ideation and resilience; and d) Case Management alone will have the weakest effects     of all combinations.   "
11701|NCT03132753|"     The investigators seek to develop and assess the effectiveness of Substance Use Programming     for Person-Oriented Recovery and Treatment (SUPPORT), a community-driven recovery-oriented     system of care for individuals recently released from prison. SUPPORT is modeled after     Indiana Access to Recovery (ATR), a program that operated between October 2007 and December     2014. ATR, a national initiative funded by the Substance Abuse and Mental Health Services     Administration (SAMHSA), provided comprehensive, flexible, recovery-oriented services for     substance use disorder (SUD). The investigators' local evaluation of this program     demonstrated significant improvement in a number of recovery-related outcomes (e.g.,     substance use, employment, income, involvement in the criminal justice system, and emotional     well-being) for clients between intake and discharge. Additionally, qualitative findings from     this evaluation demonstrated ATR was well liked among clients and providers. While Indiana     ATR did serve a wider range of clients, the investigators have focused SUPPORT on returning     inmates because (a) this was the largest group served by the program and (b) there is     significant need for evidence-based SUD interventions for this population.      The investigators' primary long-term goal is to establish an effective and scalable     recovery-oriented system of care for SUD within the reentry population. The investigators     will conduct a pilot test comparing SUPPORT clients to clients receiving usual treatment. The     investigators will collect quantitative data for both groups at multiple time points to     understand the intervention's impact on recovery capital and outcomes and will collect     qualitative data from SUPPORT clients to better understand their program and post-discharge     experiences.   "
11702|NCT03132740|"     The aim of the multi-centre study is to evaluate correctly the impact of three dimensional     visualization on operation strategy and complications for complex hepatic carcinoma.   "
11703|NCT03132727|"     To determine if MRI can detect preoperative invasion of cartilage by laryngeal and     hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised     larynges and/or hypopharynges.   "
11704|NCT03132714|"     The aim of this project is to compare the efficacy and the local effect of the association of     single or repeated application of photodynamic therapy (PDT) with antibiotic agents using     Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with Generalized     Aggressive Periodontitis (GAgP).   "
11705|NCT03132701|"     Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children   "
11706|NCT03132688|"     This retrospective study the safety and efficacy of intravenous propofol used in children     under 2 years of age during general anesthesia for surgery.   "
11707|NCT03132675|"     This will be a Phase 2 study of intratumoral pIL-12-EP plus IV pembrolizumab. Eligible     patients will be those with pathological diagnosis of unresectable or metastatic melanoma who     are progressing or have progressed on pembrolizumab or nivolumab..   "
11708|NCT03132662|"     A recent review demonstrated that Non-alcoholic fatty liver disease (NAFLD) affects 10-35% of     the adult population worldwide, with the prevalence approaching 85-100% in obese populations.     Current standard treatment for liver reduction before surgery is the use of a very low     calorie liquid diet (VLCLD). Multiple studies have shown that a 2-4 week diet with a VLCD     will reduce liver volume, in preparation for surgery. Omega-3 (Ω-3) polyunsaturated fatty     acids (PUFAs) have been suggested as a treatment for NAFLD. The primary aim of this study is     to compare Ω-3 PUFAs and a VLCLD and their effect on left lobe live size before bariatric     surgery.   "
11709|NCT03132649|"     The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional     visualization on operation strategy and complications for hilar cholangiocarcinoma.   "
11710|NCT03132636|"     The primary objective is to estimate the overall response rate (ORR) for metastatic Basal     Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when     treated with REGN2810 as a monotherapy   "
11711|NCT03132623|"     A multicenter, randomized, double-blind, placebo-controlled, phase 4 clinical trial to     evaluate the efficacy and safety of andrographolide sulfonate in patients with acute     bronchitis   "
39524|NCT02768285|"     The purpose of this study is to determine whether maintaining an apical patency causes     postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.   "
11727|NCT03132415|"     Get Connected (GC) is an online brief intervention that employs individual and systems-level     tailoring technology to reduce barriers to HIV prevention care (e.g., HIV/STI testing, PrEP)     for YMSM. The deployment of GC through a mobile-friendly WebApp seeks to optimize online     interventions' acceptability, accessibility, availability, long-term affordability among     youth. The investigators will enroll 480 self-reported HIV-negative or sero-status unaware,     sexually active YMSM (ages 15-24) across three cities and randomize them into the GC     intervention condition or to an attention-control condition. Assessments will be collected at     30 days and at 3, 6, 9 and 12 month follow-up.   "
11728|NCT03132402|"     Elimination of P. falciparum (PF) malaria across a territory requires universal access to     treatment of clinical cases for communities, and specific targeting of places or population     groups where malaria transmission persists in spite of generalized access to treatment. In     particular, a large prevalence of carriers of PF parasites is suspected to be one of the     reasons for malaria persistence. The fact that these carriers are not developing symptoms     allow them to harbour and transmit parasites over long periods of time. They are likely to     contribute significantly the transmission in their community and even beyond it according to     their movement patterns.      Identifying these pockets of high asymptomatic carriage is a key component of the malaria     elimination strategy, as it allows targeting specific interventions, such as targeted     mass-treatment, to quickly drain the asymptomatic reservoir.      Strategically to achieve this goal we need to be able to identify quickly and reliably the     villages or groups of villages in which the asymptomatic reservoir is large and should be     addressed by targeted mass drug administration (MDA).      There are no point of care tests currently available to detect asymptomatic carriers     accurately. The available Rapid Diagnostic Tests (normal RDT) are designed to diagnose     clinically relevant malaria infections. However their sensitivity for asymptomatic malaria     carriers is low, since most of these individuals harbor parasitaemias below RDT detection     thresholds. Currently, we are relying on high volume blood surveys, in which a small sample     of the village population provides a 2mL venous blood sample that can be analysed by     ultra-sensitive qPCR. This technique allows detecting very low parasitaemias. However it is a     high cost test and technical requirements to use qPCR limit the number of samples that can be     tested. In addition as the analysis must be done in a laboratory, the time needed for     shipment and analysis results in delays of 4 to 8 weeks between survey and result. Surveying     remote, poorly resourced areas adds to the challenge as the samples must be shipped from the     field to the laboratory, on cold chain, within 24 to 48h from blood draw.      To ensure that asymptomatic individuals are diagnosed in a cost effect and feasible manner,     it is vital that a more sensitive RDT is made available for use in the field. Depending on     its performance, a sensitive RDT could be used for prevalence surveys to target MDA, or     directly for interventions based on treatment of positive individuals (reactive case     detection or mass screening and treatment).      A new hypersensitive RDT (hsRDT) has now been developed but before it can be utilised for     elimination surveys we need to validate both its technical properties (sensitivity and     specificity) and its usefulness in the field to detect PfHRP2 presence compared to a gold     standard control ELISA (Enzyme Linked Immuno-Sorbent Assay) test. This will allow     confirmation of false- and true- positive among samples.   "
12394|NCT03123393|"     The purpose of this study is to assess the efficacy of TAK-659 measured by independent     radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with     relapsed or refractory diffuse large B-cell lymphoma (DLBCL).   "
11713|NCT03132597|"     Studies show a high number of medical students suffering from mental health problems.     Although there are several studies investigating how these problems could impact students'     life and performance, few studies have investigated interventions to minimize this distress.     One of these interventions is the mindfulness meditation, that has already been extensively     studied in the scientific literature showing promising results. Nevertheless, there are very     few studies which investigated how mindfulness could be implemented as a mandatory course.     The present study aims to investigate (1) how students exposed to mindfulness differ from     students not exposed to this technique concerning their mental health and quality of life in     a short and long term period. This is an intervention protocol using a randomized controlled     clinical trial with cross-over, in order to compare if the implementation of mindfulness for     first year medical students will improve their mental health and quality of life in the short     term (3 months). The intervention group (group 1) will be exposed to mindfulness in the     beginning of the medical course and will be compared to a control group (group 2), not     exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the     intervention group (group 1) will receive theoretical classes and the control group (group 2)     will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both     groups will be exposed to mindfulness in the first year of undergraduation, however in     different moments of the course. Then, these first year medical students (groups 1 and 2)     will be compared to another class (group 3), which didn't have this mindfulness mandatory     course in their formation. They will be compared after 6 months, 12 and 24 months of     intervention (long-term effect).   "
11714|NCT03132584|"     This research study is studying a combination of chemotherapy drugs as a possible treatment     for aggressive lymphoma that has not responded to standard treatment.      The names of the study interventions involved in this study are:        -  Cyclophosphamide        -  Alemtuzumab   "
11715|NCT03132571|"     The purpose of this study is to determine the efficacy of combining open-label extended     release bupropion (flexible dosing up to 450mg target) and naltrexone (37.5mg) versus     Bupropion and placebo along with a daily 500 calorie reduction diet recommendation for weight     and health risk reduction in 40 overweight/obese individuals with schizophrenia and diabetes.   "
11716|NCT03132558|"     Computed tomographic angiography (CTA) is recommended for identifying eligible patient with     acute ischemic stroke (AIS) to receieve endovascular treatment. We are going to conduct this     prospective corhot study to observe if sequential use contrast in CTA examination and in     endovascular treatment will cause acute kidney injury.   "
11717|NCT03132545|"     In a longitudinal, prospective and observational study, patients with PCOS and controls wore     the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure     (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score,     anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose     tolerance test (OGTT) and lipid profile were performed.   "
11718|NCT03132532|"     This study is being done to study which dose of proton beam therapy (PBT) for unresectable     stage 2/3 Non-Small Cell Lung Cancer.   "
11719|NCT03132519|"     Pain, cough, hypertension and tachycardia are frequent events during extubation due to a     secondary stimulation of mechanoreceptors located in the airway. The mechanical effect of the     endotracheal tube activates autonomic reflexes, a situation that could potentially impair the     clinical condition of patients. Previous studies have used remifentanil during emergence and     extubation showing good results to control this reflex response. However, it is unknown so     far, the optimal effect site concentration (Ce) of remifentanil to allow a better control of     these events with a low incidence of adverse effects after have received inhaled anesthesia     plus remifentanil for anesthetic maintenance. This study will determine the Ce of     remifentanil associated with a lower proportion of cough and hyperdynamic circulatory     response during extubation for emergency after exposure to sevoflurane or desflurane.   "
11720|NCT03132506|"     Evaluation of patient acceptance and characterization of response behaviour for web-based     compared with respective paperbacked patient reported outcomes.   "
11721|NCT03132493|"     The investigators will be retrospectively review the case note of patients registered in the     EAP of Nivolumab.      A standard anonymous data collection form will be used to collect data and to analyze it.      Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the     SPANISH expanded access programme of nivolumab.   "
11722|NCT03132480|"     Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in     children   "
11723|NCT03132467|"     The goal of this clinical research study is to find the highest dose combination of     tremelimumab and durvalumab [also called MEDI4736]) that can be given before standard of care     pre-surgery chemotherapy to patients with HR+, HER2- breast cancer. Researchers also want to     learn more about how certain immune cells may change in the body when they are given the drug     combination. Researchers also want to find out how patients with HR+, HER2- breast cancer     respond to the study drugs before they receive standard chemotherapy treatment.   "
11764|NCT03131908|"     The goal of this clinical research study is to learn if GSK2636771 given in combination with     pembrolizumab can help to control the disease in patients with refractory (has not responded     to treatment) metastatic melanoma. The safety of this drug combination will also be studied.   "
44007|NCT02709655|"     Investigation of the efficacy and safety of a new potential treatment of Major depressive     disorder (MDD) in paediatric patients (age 7 to 11 years)   "
11724|NCT03132454|"     The goal of this clinical research study is to learn more about the safety and effects of     palbociclib, when given alone and then in combination with different standard drugs to     patients with leukemia that is relapsed (has come back) or refractory (has not responded to     treatment). The standard drugs being used are sorafenib, decitabine, and dexamethasone.     Different doses of the standard drugs will be tested.      Researchers will also be performing research tests, such as biomarker, pharmacodynamic (PD),     and cytogenetic testing. Biomarkers are found in the blood/tissue and may be related to     participant's reaction to the study drug. The biomarker testing in this study will include     genetic biomarker testing. PD testing measures how the level of study drug in participant's     body may affect the disease. Cytogenetic testing looks at how genetic changes to cells may     affect how the disease may react to the study drug.   "
11725|NCT03132441|"     This study is a pilot study evaluating the feasibility and early efficacy of cardiac     rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA     class III-IV), who are being considered for LVAD therapy.   "
12395|NCT03123367|"     The Nella Women's Care Line is indicated for use in women undergoing a gynecological exam and     other gynecological procedures that require visibility and access to the cervix.      The Nella Women's Care Line is intended to provide access and visibility to the cervix.   "
11730|NCT03132376|"     Background: Consistent data from acute, single preload studies demonstrate improvements in     perceived appetite and satiety following the consumption of high-protein preloads compared to     normal protein preloads. However, it is currently unclear as to whether protein quality     (i.e., protein source) or the use of appetite questionnaires influences these outcomes.     Objective: To examine whether the consumption of protein preloads (egg white isolate, whey     isolate, micellar casein, and instant egg white) differentially modulate postprandial hunger,     fullness, desire to eat, prospective food consumption, eating initiation, and subsequent food     intake; and if the use of appetite questionnaires to assess perceived appetite and satiety     affect subsequent energy intake. Methods: Twelve young adults (age: 22±1 y; BMI: 22.1±0.9     kg/m2) reported to the research facility between 7 - 9 am to complete each 4-h testing day. A     set of questionnaires assessing perceived hunger, fullness, desire to eat, prospective food     consumption were completed followed by the consumption of the 130 kcal beverage preloads,     varying in protein source. A water preload was also included as a control. The same set of     questionnaires along with the assessment of whether they would like to eat again were     completed every 30 min throughout the 4-h postprandial period. On a separate day, all twelve     young adults also completed a similar testing day except were not given questionnaires     throughout the 4-h postprandial period. After the 4-h, the participants were given an ad     libitum pasta meal to consume until 'comfortably full.' Results: The consumption of the     protein preloads improved hunger, fullness, desire to eat, prospective food consumption and     delayed the request to eat again vs. the control (water); however, no differences in appetite     and satiety outcomes were observed between protein sources. No differences in energy content     at the lunch meal were observed between any preloads. The use of questionnaires did not     change energy consumed at the lunch meal. Conclusions: When comparing high-quality     animal-based proteins consumed as a beverage preload, relatively no differences in markers of     appetite control and satiety were detected, suggesting that protein quality has little impact     on these outcomes when consuming 30g of protein. In addition, the use of questionnaires     assessing perceived appetite and satiety do not impact subsequent energy intake.   "
11731|NCT03132337|"     The goal of this is to learn more about stem cell transplant and complications that some     people have after their transplants, in particular sinusoidal obstruction syndrome (SOS),     also called veno-occlusive disease of the liver.   "
11732|NCT03132324|"     The purpose of this study is to evaluate the safety and tolerability, and the pharmacokinetic     and biologic activity of INCB059872 in participants with sickle cell disease.   "
11733|NCT03132311|"     Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in     HIV infected individuals, compared to non-HIV-infected individuals.      Main objective:      To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies     30 days and 365 days after vaccine.      Secondary objectives:      To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte     counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy.     To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence     of adverse events in HIV-infected and non-HIV-infected individuals.   "
11734|NCT03132298|"     The goal of the project is to test whether a single-session intervention teaching incremental     theories of personality, or the belief that one's personality is malleable, can strengthen     recovery from social stress and reduce the development of anxiety and depression during early     adolescence. Results may suggest a scalable, cost-effective approach to improving youths'     coping capacities and preventing adverse mental health outcomes over time.   "
11735|NCT03132285|"     To assess the safety and acceptability of the non-surgical PrePex device among healthy adult     male participants scheduled for voluntary medical male circumcision when removing the     foreskin shortly after device placement.   "
11736|NCT03132272|"     Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic     autoantibodies against alpha1A-adrenoceptor.   "
11737|NCT03132259|"     Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in     hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli     during various stages of surgery. None of routinely used anesthetic agents effectively blunts     the undesirable hemodynamic responses, and therefore usually there is a need to use increased     doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because     its sympatholytic and antinociceptive properties may ensure optimal intraoperative     hemodynamic stability during critical moments of surgical manipulation. In addition, DEX     reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of     the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic     requirements   "
11739|NCT03132233|"     Approx. one billion people are suffering from migraine worldwide and yet, therapeutic options     are still very limited. Research suggests that changes in energy metabolism could be part of     migraine pathophysiology. Ketone bodies (KB) are endogenous alternative energy substrates.     Our clinical trial assesses the efficacy and safety of KB supplements in 60-90 adult     migraineurs (5-14 migraine days / months) at the University Hospital Basel. The total     duration of the trial is approx. 6 months, consisting of 4 weeks baseline, 12 weeks     intervention with KB powder or matched placebo and 8 weeks follow-up. The primary endpoint is     the change in migraine days at the end of intervention compared to baseline. Additionally,     changes in gene expression, fat-, and glucose metabolism, inflammatory markers and quality of     life will be examined.   "
11765|NCT03131895|"     The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30     milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant     Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule     manufactured at Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC).   "
11766|NCT03131882|"     Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided     Corticosteroid Injection in Treatment of Trigger Finger   "
11740|NCT03132220|"     Developed over 10 years ago, Mindfulness Based Cognitive Therapy (MBCT) synergistically     combines mindfulness training and cognitive behavioral therapy and can increase resiliency.     In this study, the investigators proposed two aims: Aim #1: To adapt and optimize a MBCT     resiliency program specifically for ICU nurses. For this aim, the investigators will engage     multiple stakeholder groups to assist the protocol adaptation. Aim # 2: To conduct a pilot     clinical trial to determine acceptability of the MBCT resiliency program and the control     intervention. In this aim, the investigators will also identify the most feasible     randomization level to minimize contamination between the control and intervention groups.     Collectively, this proposal will pave the way for a properly designed large multi-center     trial of a MBCT resiliency program (MBCT-ICU) to determine its ability to decrease BOS     symptoms; and allow nurses to more effectively care for patients in the challenging ICU     environment.   "
11770|NCT03131830|"     The primary aim of the study is to investigate personal attitudes regarding mode of delivery     among both medical health care professionals and non-professionals. The investigators are     also investigating whether providing detailed information that might influence one's decision     regarding mode of delivery (such as education on pelvic floor disorders or advantages or     disadvantages of epidural anaesthesia) will change participants´ opinion how to determine     their preferred mode of delivery.   "
11741|NCT03132207|"     Epidemiological studies have suggested that maternal periodontitis affects the     fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has     been suggested that the direct or indirect action of parodontopathogenic bacteria induces an     inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries     and periodontal disease can lead to acute pain and stress. This may promote self-medication     and the inappropriate use of analgesic medications, potentially harmful to the health of the     fetus. As part of the prevention of complications of pregnancy associated with oral diseases,     the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system     that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral     health professional to carry out a complete assessment and free care. This study aims at     evaluating this device among pregnant women and healthcare professionals 4 years after its     implementation. On the other hand, it will make it possible to look for a possible link     between the realization of an oral prenatal follow-up and the outcome of the pregnancy.   "
11742|NCT03132194|"     To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.   "
11743|NCT03132181|"     SGLT2 inhibitors are a novel class of glucose lowering drugs that act in the kidney by     inhibiting SGLT2-mediated glucose reabsorption in the proximal tubule. The resulting increase     in urinary glucose excretion leads to a reduction in plasma glucose levels. This is     accompanied by reduction of total body weight due to urinary energy loss. In addition,     glucose dependent osmotic diuresis contributes to blood pressure lowering effects of SGLT2     inhibition.      Aim of the trial is to assess hemodynamic changes by empagliflozin, identify new     empagliflozin dependent metabolic regulators and evaluate empagliflozin dependent effects on     cardiac function.   "
11744|NCT03132168|"     In this study, post-operative delirium will be measured in patients undergoing surgery for     bladder resection, and associated microRNA biomarkers will be evaluated in patients     considered delirious and non-delirious after surgery.   "
11745|NCT03132155|"     This is a phase 2 study that will assess the efficacy of AMG 337 in subjects with advanced or     metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion.   "
11746|NCT03132142|"     The purpose of this study is to investigate the potential desensitising effects of repeated     applications of capsaicin, trans-cinnamaldehyde and L-menthol on thermal, mechanical and     chemical sensory stimulations.   "
11747|NCT03132129|"     Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus,     but its pathophysiology is poorly understood.      Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction     in adults with type 2 diabetes (T2D).      Plan: 150 asymptomatic older adults (aged 50-75 years) with T2D will undergo comprehensive     evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy,     echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling.     Fifty controls will undergo the same evaluation.      Primary hypothesis: myocardial steatosis is an independent predictor of left ventricular     global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive     to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac     dysfunction is related to peak oxygen consumption.      Expected value of results: This study will reveal the prevalence and determinants of cardiac     dysfunction in T2D, and could provide targets for novel therapies.   "
11748|NCT03132116|"     To compare effect of intra-nodal injection of gentamicin versus placebo on the outcome at 28     days of suppurated cat scratch disease's (CSD) lymphadenitis treated by oral azithromycin.   "
11749|NCT03132103|"     The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D     status, immunity and physical performance.   "
11750|NCT03132090|"     Therapeutic agents used in malignant melanoma treatment such as BRAF/MEK inhibitors and     anti-CTLA-4/Anti-PD-1 antibodies go along with harmful side effects in a considerable     proportion of patients and treatment costs may cause relevant medical expenditures per month.     Currently, therapy response assessment in melanoma patients is performed using RECIST     criteria which are based on changes in tumour size. PET/CT combines morphological and     metabolic information. Thus, the so-called PERCIST-criteria were introduced integrating     change in size and glucose utilization for response assessment in solid tumors. Due to the     different mechanism of action these new agents introduce different response patterns increase     in tumor size due to inflammation for antibody therapies). In conventional chemotherapies,     re-staging is usually performed 3 months after treatment initiation which is the result of     empirical investigations. Moreover, it has recently been shown, that response to new targeted     therapies can be detected much earlier using PET or functional MR techniques. This forms the     rationale for the monitoring of melanoma patients using a combined PET/MR technique after     only 2 weeks of therapy initiation. Especially for patients in stage IV with a medium     survival time of 12 months, a 2.5 months earlier re-staging and therapy adjustment would have     significant consequences for the individual clinical course.   "
11751|NCT03132077|"     The intention is to explore whether there are factors which help us to understand why some     patient outcomes are not successful and identify prediction factors for progression. It will     also assess the available outcomes pre- and post-surgery may explore prediction tools for     good/poor progression and improve the patient's selection, patient preparation or timing for     surgery.      The focus of this project is exploring outcomes post-primary total knee arthroplasty (TKA)     using the available pre/post-operative Oxford Knee Score (OKS), University of California Los     Angeles (UCLA) Activity Score, EQ-5D General Health Questionnaire, Visual Analogue (VAS) for     pain, age and smoking status data, and correlations between these data and post operation     patient satisfaction.   "
11769|NCT03131843|"     Alcohol is used to disinfect the skin prior to injections in order to prevent infections     caused by bacteria on the skin being injected within tissue. At present, however, clinical     trials do not demonstrate a clinical impact of using or not using alcohol swabs on infections     and infection symptoms calling into question the practice of using it prior to all     injections. These studies are methodologically flawed, and do not specifically examine     vaccine injections. The present study is being undertaken to provide some preliminary data     for the risk of infection and infection symptoms when alcohol swabs are not used to perform     vaccine injections.   "
11771|NCT03131817|"     This study will investigate cortical stimulation to treat mood and behavioral symptoms in     Parkinson's disease patients.   "
11752|NCT03132064|"     To explore whether there are factors that help us to understand why some patient outcomes are     not successful and identify prediction factors for progression. Assess central pain     sensitisation and psychology pre- and post-surgery with reliable tools that explore     prediction tools for good/poor progression and improve patient selection, patient preparation     and timing for surgery.      The aim of this project is to explore the effects of pre-surgical central pain sensitisation     on pain and function outcomes post-TKA. Central pain sensitisation will be assessed using     pressure algometry and the Pain Catastrophizing Scale will be used to explore pain     psychology. Functional outcomes post-TKA will be assessed using a commonly used scale for     patients' self-reported outcomes (Oxford Knee Score), visual analogue scale, a star excursion     balance test and four recommended patient performance-based tests.   "
11753|NCT03132051|"     The objective of this study was to assess sonographic changes of the median nerve after     steroid injection for carpal tunnel syndrome.   "
11754|NCT03132038|"     INDICATION:      Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed     during the 6 months period before entering the study and who are eligible for nivolumab     monotherapy.   "
11755|NCT03132025|"     To control apatinib and capecitabine combination to maintain treating metastatic colorectal     cancer.   "
11756|NCT03132012|"     This is a pilot randomized controlled trial of an Internet-based skin cancer prevention     intervention as compared to a standard of care control in 80 non-Hispanic white females ages     20-30.   "
11757|NCT03131999|"     This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with     lymphangioleiomyomatosis (LAM).   "
11758|NCT03131986|"     Since the debut of imatinib, the first tyrosine kinase inhibitor(TKI), more than two decades     ago, the prognosis of patients with chronic myelogenous leukaemia (CML) has continued to     improve. It has been shown that life expectancy of CML patients is approaching that of the     general population nowadays. Currently, indefinite use of TKIs in patients with chronic-phase     CML who achieve optimal response remains the standard practice. Nevertheless, the concepts of     treatment-free remission and functional cure have been hotly discussed in recent years. A     number of major international clinical trials have demonstrated that about 40-60% of CML     patients who previously enjoyed deep molecular response on TKI manage to stay free from     molecular relapse after cessation of TKI therapy.      Local experience of TKI cessation is lacking. This study aims to recruit patients diagnosed     with CML, chronic phase who are treated with TKIs and remain in stable deep molecular     response for at least two years. It is planned to stop TKI in these patients with regular     monitoring, and determine their outcomes.   "
11759|NCT03131973|"     Drug-drug interaction study in healthy men. Assess the effect of BMS-986195 on the movement     of methotrexate into, through, and out of the body. Collect data on safety of BMS-986195 and     methotrexate.   "
11760|NCT03131960|"     This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are     implanted with the Vivistim System® and then randomized to either study treatment or     active-control treatment. The randomization will be stratified by age (<30, >30) and baseline     FMA UE (20 to <35; >35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered     during rehabilitation. Active control treatment is rehabilitation (standard-of-care     treatment) with only a minimal amount of VNS at the start of each session intended to support     blinding.   "
11761|NCT03131947|"     Adult patients > 18 years with fresh (within 2 weeks of injury), closed and open, tibia and     femur fractures who undergo IM nailing for fracture fixation will be eligible for the study.     Participants will be recruited over 24 months. Participants will undergo a baseline     questionnaire, HIV testing and assessment of their BMD. They will be followed up at 6 weeks,     and 3, 6 and 12 months. All adult patients who develop delayed bone union at 6 month follow     up will be considered cases. Adult patients who show evidence of radiological union at 6     months or less will be considered controls.   "
11762|NCT03131934|"     This is an open label, non-randomised, multicentre Phase I to determine the safety of     tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (EBV CTL) and compare their     expansion/persistence with control EBV CTL in solid organ transplant patients with     post-transplant lymphoproliferative disease (PTLD). Each patient will receive an infusion of     two ATIMPs - autologous EBV CTL retrovirally transduced with (a) a calcineurin mutant (CNA12)     that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8).   "
11763|NCT03131921|"     This is an observational study to assess the determinants of energy expenditure in cancer,     and how those change throughout the disease trajectory. The investigators hypothesize that     skeletal muscle will be the primary determinant of energy expenditure throughout the disease     trajectory and that sarcopenic individuals will have lower activity levels.   "
11780|NCT03131700|"     The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab     products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration     at 5 mg/kg fixed dose.   "
11767|NCT03131869|"     People suffering from swallowing disorders (dysphagia) have a hard time swallowing liquids     that are too thin (like water or coffee) or too thick, correctly. They can have health     problems, such as chest infections and malnutrition because when they try to drink, some of     the liquid goes down the wrong pipe and into the lungs. To help people with dysphagia,     Swallow Solutions is developing thickened liquids that have added nutrition, taste good, and     quench thirst, but are still easy and safe to swallow.   "
11768|NCT03131856|"     This study aims to investigate the effect of a multi-disciplinary nutritional intervention     program in geriatric nutritional at risk patients. The study is carried out as randomized     controlled trial. The intervention consists of an individual dietary plan conducted by a     clinical dietician before discharge in combination with three follow-up visits after     discharge (1, 4 and 8 weeks).   "
11772|NCT03131804|"     Hemodialysis (HD) patients have decreased physical functioning, diminished muscle mass and     altered muscle quality thus the increased mortality rate compared to their age-matched     population. Risk factors include their sedentary lifestyle and altered nutritional status     [1]; the sedentary lifestyle or the lack of exercise is known to be a risk factor for     cardiovascular complications [2] and contributes to worsen protein energy wasting (PEW),     which is described as the loss of body protein mass and fuel reserves [1]. Therefore the     health of the HD patients and consequently their quality of life (QOL) is deteriorated.      Studies have shown that aerobic exercise during HD improves aerobic capacity, blood pressure,     heart rate, muscular strength, dialysis efficacy and quality of life; however, such studies     were not done on the United Arab Emirates (UAE) HD patients and there is no protocol for     implementing exercise in the UAE HD units [3-4]      Hypothesis: Intradialytic aerobic exercise will result in significantly improved clinical,     cardio-metabolic and quality of life outcomes and reduced cost of care.      Primary objective of the study:      - To investigate whether the intradialytic exercise (IDE) within the routine practice of     hemodialysis in the UAE will improve adequacy of dialysis.      Secondary objectives of the study:        -  To study the effect of clinical and cardio-metabolic outcomes of the HD patients.        -  Explore whether the trial would improve the cost effectiveness of this patient          population's health care        -  Define the nature of the IDE programs (intensity, duration, modality), and feasibility          of its application in routine setting.      Importance of this research:        -  Pioneering research in the Middle East and Gulf Cooperation Council (GCC) countries          where the effect of intradialytic exercise will be studied for the first time on Arab          population.        -  It will contribute in identifying the exact strategies to integrate within the          hemodialysis unit to improve clinical and cardio-metabolic outcomes, quality of life and          healthcare cost.      Usefulness of this research to the UAE        -  It will improve the health care cost and reduce cost wastage in the UAE (lean          management).        -  It will put UAE on the pedestal in front of other countries in integrating innovative          methods for a better care of hemodialysis patients.   "
11774|NCT03131778|"     Patients with resectable liver metastases of colorectal origin will be assigned to     laparoscopic liver resection or conventional open liver surgery.      Blood samples will be drawn preoperatively and 24 hours after resection. Determination of     Interleukin-6 (IL-6) and IL-8 will be done to assess the stress response between open and     laparoscopic liver resection (Elisa test).      The Messenger Ribonucleic Acid (mRNA) of inflammation related factors (cyclooxygenase-2     (COX-2) and Matrix metalloproteinase (MMP-9)), angiogenesis related factor (vascular     endothelial growth factor (VEGF) and hypoxia induced factor-1 (HIF-1)) in tumor tissue and     normal liver parenchyma will be detected by real-time real time-Polymerase Chain Reaction     (RT-PCR).   "
11775|NCT03131765|"     Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced     solid tumors who have limited available treatment options, and exploratory evaluation of the     pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts:     dose escalation and cohort expansion   "
11776|NCT03131752|"     Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic and progressive     airflow limitations and subjects with COPD also experience exacerbations characterized by the     worsening of respiratory symptoms. It's necessary medical intervention, changes in regular     medication, and the use of antibiotics and/or corticosteroids followed or not by     hospitalization. The exacerbations contribute to worsening of the disease with systemic     impairment and muscle weakness is a very relevant event. The physical inactivity, especially     related to bed rest, comprises one of the factors contributing to muscle atrophy and loss of     muscle strength. Thus, the intervention performed during hospitalization is necessary to     minimize the consequences which causes impairment in health status subjects. The aim of the     study is assess the effect of the intervention with elastic bands, in muscle strength,level     of the physical activity, functional capacity, dyspnea on activities of daily living (ADL)     and quality of life in COPD exacerbation subjects. Moreover,verify the intervention benefits     over 01 and 03 months post exacerbation episode. It will be a prospective, randomized,     longitudinal and interventional study. The investigators will be asses both gender patients     with exacerbation of COPD in 4 situations: First time (at least 24 and at most 48 hours after     the beginning of medical therapy); seven days post the first assessment; one and three months     post exacerbation episode. It will be assess the muscle strength, physical activity level,     functional capacity, dyspnea on ADL and quality of life. The patients will be randomized in 2     groups: intervention and control group. The intervention will be performed with elastic bands     once a day during seven days. The investigators expected that patients of the intervention     group will present better muscle strength, physical activity level and functional capacity     than the control group. Furthermore, an improvement in dyspnea and quality of life is     expected in intervention group when compared as with control group patients. It is     hypothesized that the benefits of intervention will be maintained over one month.   "
11777|NCT03131739|"     The goal of the Alaska Native Resilience Research Study (ANRRS) is to identify     community-level protective factors that can most effectively reduce co-occurring youth     suicide and alcohol risk. The following specific aims will help us achieve this overarching     goal. The research team will: (1): Assess the association of a set of modifiable cultural,     community and institutional factors (protective community factors) with suicide, suicidal     behaviors (ideation, attempt), and associated adverse outcomes (accidental death,     alcohol-misuse requiring healthcare) in 64 rural and remote Alaska Native villages to     identify community-level factors that are most predictive of youth health outcomes; (2): In a     stratified random sample of six communities, use quantitative methods to test a multi-level     model of individual-level youth protective factors as predictors of individual-level youth     resilience from suicide risk outcomes; and (3): Develop and disseminate a method—Alaska     Community Resilience Mapping (AK-CRM)—for communities to measure and strategically strengthen     their protective capabilities to increase youth health and reduce the risk for suicide.      Methodology:   "
11778|NCT03131726|"     In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim     at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients     with mild to moderate Graves´ ophthalmopathy treated with diclofenac, simvastatin or no     treatment.   "
11779|NCT03131713|"     The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate     drinks on pain and functional status experienced by patients undergoing Mohs micrographic     surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of     care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before     surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger,     fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of     skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after     their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage     of over the counter or prescribed pain medications, and presence of complications e.g.     bleeding, infection, dehiscence. Differences in perioperative functional status and pain     medication usage are compared between patients in control and intervention groups.   "
11782|NCT03131674|"     This study investigates the effect of cervical physical therapy on tinnitus annoyance in     patients with somatic tinnitus. This study specifically enrolls patients with co-varying     tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be     influenced by neck movements or positions.      These inclusion criteria were chosen, since a prior study showed that these factors were good     prognostic indicators for a positive treatment effect.   "
11783|NCT03131661|"     The purpose of this Italian multicenter study is to collect prospective clinical data in     participants with first diagnosis or confirmation diagnosis of Spondyloarthritis (SpA),     according to Assessment of Spondyloarthritis classification (ASAS) criteria, in order to     describe SpA characteristics and pattern of clinical presentation.   "
11784|NCT03131648|"     Primary objective:      To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe     AD.      Secondary objectives:      To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health     related quality of life compared with placebo.      Maintenance objective:      To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared     to placebo for subjects achieving clinical response at Week 16.   "
11786|NCT03131622|"     The purpose of this research is to determine if Ibis™, a digital therapeutics solution     developed by Senscio Systems, reduces the emergency room visits and hospitalizations of     patients with COPD.   "
11787|NCT03131609|"     The purpose of this study is to find the best cleaning and collection methods to obtain a     'non-contaminated' clean catch mid-stream urine sample to diagnose suspected urinary tract     infection (UTI).   "
11788|NCT03131596|"     In this prospective, randomized, controlled study, the investigators wish to determine the     efficacy of intrauterine balloon (IUB) dilatation in the prevention of adhesion reformation     when compared with the conventional management.   "
11789|NCT03131583|"     The objective of the study is to assess the pharmacodynamic properties of drug-drug of     SHR4640, Febuxostat and Colchicine interaction in patients with gout.   "
11790|NCT03131570|"     Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic     inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing     mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may     reduce the costs of treating psoriasis and associated medical conditions, including psoriatic     arthritis, cardiovascular disease, and diabetes.   "
11791|NCT03131557|"     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted     on hard of participants with a hearing loss to grant quality control prior to product launch.     The aim of the investigation series is to ensure usability, zero-defect overall performance     of the new hearing systems as well as maximum benefit for the participant with the devices in     comparison to previously outstanding Phonak Hearing Systems.   "
11792|NCT03131544|"     Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to     evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm     laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic     hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within     the prostate under MRI guidance. This will be a single center, single arm prospective trial     with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose     to be part of the study will be enrolled consecutively.   "
11793|NCT03131531|"     This registry has been established to gain a better understanding of the clinical and     biological characteristics and outcome of patients with lymphoid cancer   "
11794|NCT03131518|"     There is a need for a greater understanding of e-bikes and their role in the transportation     network, and further effects on physical activity (PA) levels and health. Moreover, longtail     bikes could meet certain practical needs not sufficiently fulfilled by e-bikes or traditional     bikes, hence increased knowledge regarding their potential and feasibility should be     obtained. No intervention study has investigated whether providing an e-bike or a longtail     bike over an extended period in a sample of inactive parents of toddlers influence     objectively assessed amount of cycling, total PA level, potential mode shifts, and effect on     cardiorespiratory fitness, body composition and blood pressure.      Objectives:      To assess the effect of an intervention where participants have access to an e-bike     (including a trailer), a longtail bike and a traditional bike (including a trailer) on the     following parameters:        1. Objectively assessed amount of biking, total levels of PA, and mode shifts from          car/motorized modes to bicycle.        2. Cardiorespiratory fitness, blood pressure, body composition, self-reported health and          health-related quality of life (HRQoL).        3. Experiences with bicycling (el/longtail/traditional) and intrinsic motivation for          bicycling.        4. How season and weather conditions influence the amount of bicycling          (el/longtail/traditional).        5. Potential spill-over effects on the participants' partners      Study sample:      A convenience sample consisting of 36 inactive parents of toddlers will be recruited among     residents in Kristiansand municipality, Southern Norway.      Measures:      The following measures will be conducted at baseline and post all intervention arms, i.e. in     total 4 times:        1. A web-based questionnaire will assess socio-demographics (at baseline only),          transportation habits, self-perceived health and HRQoL, and motivation for bicycling for          transportation. Participants' partners will be requested to fill in the questionnaire at          baseline and post-intervention to detect potential spill-over effects.        2. Cycling time and distance will be assessed through usage of a mobile application.           Time spent in moderate-to-vigorous PA (MVPA) will be estimated with the monitor          SenseWear Armband Mini (SWA) for seven consecutive days at study start and after 3, 6          and 9 months.        3. Cardiorespiratory fitness will be measured performing treadmill walking/running, and          dual-energy X-ray absorptiometry (DXA) will be used for assessing body composition. In          addition, blood pressure, body weight and height (height only at baseline) will be          measured at baseline and post-intervention.        4. Participants' experiences with and motivation for usage of the different bicycle types          will be explored in semi-structured focus group interviews after 3 months, 6 months and          9 months.      Weather data (temperature, rainfall, snow, etc.) will also be collected.      Scientific contribution:      The present study will add knowledge to relevant and topical areas, i.e. issues related to     public health and environmental sustainability, among parents of toddlers, representing a     target group of utmost importance.There is a call for research on the influence of e-bikes on     travel behavior and level of MVPA, and whether voluntary cycling with e-bikes could improve     health. Moreover, to our knowledge no scientific studies have assessed possible effects of     using a longtail bike, on the selected parameters. If the current study reveals promising     results, it should be replicated in a larger and more representative sample of     kindergarten-parents, as well as in other important target groups (e.g. older adults). If     findings are positive, inclusion in national public health policies should be considered.   "
11795|NCT03131505|"     The focus of this study is not about what it is like to have a mental disorder, but instead     the diagnostic experience.      Some people find diagnoses helpful, but some find them upsetting and harmful. Research is     therefore needed to improve diagnostic processes. It has been suggested that patient     experiences and outcomes may be affected by the diagnostic tools used, including diagnostic     criteria, labels and language. In the NHS, the tool used by doctors to help diagnose people     is a guidebook called the International Classification of Diseases (ICD). A new version of     this guide is due to be released in 2018.      This project will use focus groups to ask people who use mental health services and     diagnosing doctors in those services what they think about the labels and language in the new     guide. The investigators can then suggest changes before the guide is published. The     investigators hope that this research will improve mental health diagnosis. The research will     take place in Norfolk and Suffolk and span eight months.   "
11796|NCT03131492|"     EDMOCS trial pretends to evaluate if C-reactive protein (CRP) and procalcitonin (PCT) can     predict intestinal anastomotic leaks before early discharge in advanced ovarian cancer     surgery requiring intestinal resection. These markers have already been positively tested in     colorectal cancer surgery, but not yet in ovarian surgery.      Patients undergoing intestinal resection in ovarian cancer surgery will be included.     C-reactive protein and PCT will be measured pre-operatively, and on the second, fourth and     sixth postoperative day. Thirty-day readmissions, re-operations and mortality will be     recorded.   "
12454|NCT03122717|"     This research study is studying a combination of two drugs as a possible treatment for     Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.      The interventions involved in this study are:        -  Osimertinib (Tagrisso)        -  Gefitinib (Iressa)   "
11797|NCT03131479|"     The purpose of this trial is to evaluate whether the study drug, LIK066, causes glucose     excretion in urine in patients with varying degrees of decreased kidney function and in     subjects with normal kidney function. Blood samples will also be collected to measure the     concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is to     study how LIK066 is absorbed, distributed and eliminated, in other words what the body does     to the drug. The results of this study may be used to help determine whether LIK066 can be     used to treat people with reduced kidney function and the proper dosing regimen.   "
11798|NCT03131466|"     The study is designed to compare the effectiveness and safety of high-voltage Pulsed     radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients     with ineffective conservative treatment and explore better non-surgical treatment methods for     Trigeminal Neuralgia patients.   "
11800|NCT03131440|"     The overall objective of the proposed research is to pilot test the feasibility and     acceptability of a set of more scalable technology-supported physical activity promotion     intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy     Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess     the effects of individual intervention strategies, and thereby identify which strategies and     what strategy levels make the important contributions to the overall program's effect on     physical activity. This information then guides assembly of an optimized physical activity     program, that achieves target outcomes with least resource consumption and participant     burden. The resulting intervention will have great potential for scalability because it uses     technology (smartphones) participants already own and requires no on-site visits.   "
11801|NCT03131427|"     CR-GMLD registry started on June 13, 2015 to collect cases of genetic/metabolic liver     diseases from tertiary or secondary hospitals in mainland China. Demographics, diagnosis,     laboratory test results, family history and prescriptions were recorded. Patients' whole     blood and serum were collected for genetic testing and future researches. These patients will     be followed-up every six to twelve months.   "
11802|NCT03131414|"     The IMAGINE Cohort Study will identify and recruit a cohort of 8000 patients with IBS, IBD     and healthy controls (2000 of each) who will be assessed in terms of their psychological     status, dietary intake, gut microbiome, metabolomic and inflammatory markers and genotype,     health-related quality of life, and health care resource use and associated costs. The cohort     and healthy controls will be followed prospectively for up to 5 years after the completion of     study enrolment.   "
11803|NCT03131401|"     Lymphatic filariasis is a neglected tropical disease earmarked for elimination as a public     health problem by the year 2020. Since the year 2000, the Global Program for the Elimination     of LF has together with endemic countries undertaken preventive chemotherapy in endemic     districts to entire at risk populations. In Ghana, treatment of LF is based on the drugs     Ivermectin and Albendazole. Remarkable achievements have been made towards the control and     elimination of LF in Ghana. However, there remain programmatic and implementation challenges     that need to be addressed in order to ensure that the gains made over the last 15 years are     sustained. Among these challenges is the persistent transmission of LF in some districts     despite more than 10 years of MDA.      Furthermore, LF cases have been identified in communities from eight districts, previously     considered as non-endemic. The extent of endemicity in these new districts is unknown. In     order to achieve the 2020 elimination targets, it is crucial to determine the distribution     and infection prevalence of LF in these districts. Evaluating these districts for LF     endemicity will help the implementation of appropriate strategies towards achieving the 2020     target.      This protocol describes the surveys to be undertaken in Ghana in 3 of these districts. The     current standard mapping methodologies of LF have the potential to miss LF endemic villages,     due to the focal nature of LF. As such, in order to enhance the chances to detect endemic     communities, this survey will use a combination of the WHO EPI cluster survey and current LF     mapping protocols. 15 communities will be selected in each district, with 100 survey     participants per community. Survey participants will be screened for LF infection using     immunological and parasitological methods. Study participants will also be tested for     onchocerciasis infection using immunological and parasitological methods in districts where     LF and oncho are co-endemic. The information from this survey will be combined with the data     on the LF vectors and their infection status in the survey areas and relevant data available     at the Ghana Health Service to:        1. determine whether LF intervention strategies are indicated in these three districts,        2. design, as indicated, appropriate intervention strategies to achieve LF elimination in          these three districts by 2020        3. inform, if indicated, co-implementation of control, monitoring and evaluation for LF and          onchocerciasis in the two onchocerciasis endemic districts        4. extract lessons learnt for the design and implementation of surveys in the other          districts currently considered non-endemic but where LF cases have been reported.      New rapid diagnostic tests have been developed to assess infection Lf and onchocerciasis     infection prevalence at the time of the decision to stop MDA and for surveillance for new     infections once MDA has been stopped. These include Rapid Diagnostic Tests (RDT) for     antibodies against the W. bancrofti antigen WB123 and the O. volvulus antigen Ov16. These     tests still require large scale field validation. Provided additional funding becomes     available, this survey will be used to obtain field validation data.   "
11804|NCT03131388|"     The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility     assessment. The purpose of the study is to evaluate the clinical performance of the Access     AMH Assay in the intended use population.   "
11805|NCT03131375|"     Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia.     The investigators intend to study the efficacy of DEX in reducing ED in children undergoing     tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with     propofol .   "
11806|NCT03131362|"     This is a multi-centre, prospective, observational study to realize the current situation of     COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites     around China and followed up for one year. During this study, patients will undergo clinical     assessments and receive medical care as determined by their treating physician.   "
11807|NCT03131349|"     Short stature is defined as height below 3rd centile or less than two standard deviations     below the median height for that age and sex according to the population standard zinc and     iron have important role in growth for children   "
11808|NCT03131336|"     The purpose of this study is to test the effectiveness and safety of a new peptide-based     coagulant, PeproStat. The study drug will be applied to patients undergoing liver/soft tissue     surgery, vascular surgery or spine surgery. The speed of action of the new coagulant, that is     applied with a gelatin sponge, will be compared to the same sponge but with saline (a     commonly used standard of care).   "
11809|NCT03131323|"     Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population     in different countries. It carries a significant burden to children, their families, the     healthcare system and the overall community.The purpose of the study is to delineate the     prevalence of abnormal nasal finding in wheezy children and evaluate the role of the     endoscopic examination of the nose in evaluation and management of a wheezy child.Patients     and methods:The study will be conducted as a prospective case series including all children     having chest wheezes, aged from two years to eighteen years, attending emergency unit of     assuit university children hospital   "
11810|NCT03131310|"     CPR will be done based on American Heart Association Guidelines for Cardiopulmonary     Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.   "
11811|NCT03131297|"     Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of     cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but     with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula     tract without lesion of anal sphincter.      Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency     procedure.      Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50     patients with low, high, complex and Crohn disease fistula. An intermediate analysis is     expected after the first 20 patients, to verify morbidity.      Evaluations :        -  Fistula clinical healing 6 and 12 months after procedure        -  Fistula MRI healing 12 months after procedure        -  Anal continence before and after procedure        -  Feasibility og radiofrequency procedure        -  Morbidity        -  Success and failure prognostics factors of this procedure   "
12149|NCT03126734|"     This study aims to analyze whether the course of infant massage serves as a tool to improve     acceptance, commitment and awareness of influence of parents of babies with Down syndrome.     These variables will be measure before and after the course of infant massage in the     experimental group, investigators will make measurements with the same rate in the control     group, but they will receive the course after the measurements.   "
11812|NCT03131284|"     AIM:      to reduce the prevalence of overweight and obesity at two years of age in the intervention     group compared to the control group.      METHODS:      Eleven primary paediatricians were randomized to the intervention group and intensively     trained about the trial intervention. Each of them was asked to consecutively recruit the     parents of at least 30 newborns taken in charge within the first year of the study, and to     provide them with standardized oral and written information on protective practices during     all the well visits scheduled in the first two years of the child's life.      Another eleven primary paediatricians were randomized to the control group, and were asked to     consecutively recruit the parents of at least 30 newborns taken in charge within the first     year of the study and to provide them with usual care and follow-up. When all recruited     children have completed the second year of life, the two groups of toddlers will be compared     as regards the prevalence of overweight/obesity, defined by WHO cut-offs of the weight/length     ratio.   "
13308|NCT03111342|"     The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain     scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion     in nulligravida women.   "
11813|NCT03131271|"     Background: Removal of femoral arterial catheter causes pain, and current interventions used     for reducing this pain are not sufficiently effective.      Aims: The aim of this study is to determine the pain reduction effectiveness of ice bag     applications to the femoral region in patients undergoing percutaneous coronary intervention.      Design: A randomized controlled trial with repeated measures and two-group design.      Setting: This study was conducted at the Yilmaz-Mehmet Oztaskın Heart and Vascular Hospital     located in Kayseri, Turkey.      Participants: The study was completed with a total of 104 patients who met the inclusion     criteria: 52 each in the experimental group and the control group.      Methods: The data were collected by the researcher using Patient Identification Form,     Numerical Rating Scale (NRS), and Vital Signs Monitoring Form. An ice bag was applied to     patients in the experimental group for 20 minutes before removal of the catheter. The nurse     performing the application was also responsible for the catheter removal, immediately after     the ice bag was removed. Standard procedures of the clinic were applied to the control group.     According to the relevant standard procedures, the catheter was removed by the nurse without     making any other application to femoral region, and pressure was applied on catheter site.     The pain experienced by the patients was evaluated before, and during removal and again while     the nurse applied pressure on the catheter site after removal. The NRS scores were identified     as NRS1, NRS2 and NRS3 for the three assessment, respectively.   "
11814|NCT03131258|"     Kidney transplant is the most effective choice of treatment for patients with end-stage     kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney     transplantations are implemented with living donors.      Donor nephrectomy is an operations which has the end goal of a living donor donating one of     his kidneys to a patient with end-stage kidney failure (1).      Pre-operative anxiety is a condition which is characterized by a random illness, being     hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is     to be experienced. Educating and informing in the pre-operative period is the first step in     mentally preparing the patient for the operation. In some studies, it has been pointed out     that patients who were thoroughly informed in the pre-operative period have lower anxiety     levels both in the pre-operative and post-operative periods with also less levels of pain and     increased recovery rates in the latter (2).      Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized     patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle     strength.      Post-operative pain is acute pain which starts with surgical trauma and ends with tissue     healing (3). Providing optimal post-operative analgesia plays an important role in the     prevention of post-operative complications (1,4,5).      There are studies which examine the link between pre-operative anxiety and post-operative     pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific     group of patients both because they are not operated due to a health problem that they have     and because the operation results with them losing an organ. There are no prospective studies     about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in     individuals who have undergone donor nephrectomy in literature. Because of this, we have     aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery     and post-operative pain in patients that were to undergo donor nephrectomy surgery.   "
11815|NCT03131245|"     Changes of optic nerve sheath diameter after position changes   "
11816|NCT03131232|"     In summary, the registry should provide novel insight into potential mechanisms of     cardiovascular risk reduction in patients treated with Empagliflozin with an indication of     intensified glucose lowering therapy based on their HbA1c level.   "
11817|NCT03131219|"     The purpose of the study is to assess the efficacy of ALXN1210 to control disease activity in     children and adolescents with aHUS who have not previously used a complement inhibitor.   "
11818|NCT03131206|"     This research trial is studying a drug called alectinib as a possible treatment for non-small     cell lung cancer (NSCLC) with specific genetic alterations known as ALK or RET     rearrangements, and thyroid cancer with RET rearrangements.   "
11819|NCT03131193|"     The evidence on how primary care provider supply and skill relates to patient outcomes is     limited and inconclusive. The issue of skill is a particularly important one in low-income     countries where the shortage of skilled medical professionals has led to greater use of the     task-shifting model in which medical tasks are redistributed from highly skilled health     workers to mid-level providers who receive less training. In this large-scale     cluster-randomized trial, the investigators randomly select primary health care facilities to     receive a highly skilled provider (a doctor), a mid-level health provider, or no additional     providers (the control group). The investigators study the effect of this intervention on     patient outcomes. Embedded within this trial is another experimental intervention in which     pregnant women residing in communities served by the primary health care facilities are     assigned to receive a cash transfer conditional on using antenatal, delivery and postnatal     care. The investigators study the effect of the cash transfer on health care utilization and     on maternal and infant outcomes.   "
11820|NCT03131180|"     Engaging patients and families to take an active role in their healthcare leads to improved     outcomes. Providing physicians and families with near real-time data on outcomes in children     with similar medical conditions can allow families to form realistic expectations and take an     active role in their child's health. It also provides physicians with near real-time feedback     on patient-reported outcome measures to guide both conversations and recommendations for     therapy at the point-of-care.      A rapid learning healthcare system (RLHS) is a system that merges clinical research and     clinical care. It is designed to collect data during routine patient care and then utilize     the data to rapidly generate evidence to improve patient care, provide information to     patients and families, and track quality measures.      The investigators created a RLHS that integrates pre-specified data elements and validated     surveys within the clinical workflow in order to operationalize automated research data     collection and integrate predictive analytics into the electronic health record (EHR).     Patients, caregivers, and physicians can access data in order to make informed, shared     decisions about care and align expectations about outcomes.   "
11821|NCT03131167|"     Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the     investigational SHP639 eye drops will be evaluated in subjects with high eye pressure or     primary open-angle glaucoma. There will be up to 12 cohorts in total, 1 cohort for each dose     level and different dosing regimen. Each cohort will consist of 7 subjects for a total of 84     subjects in the study. Eligible subjects will be randomly allocated in a 5:2 ratio to receive     either SHP 639 or placebo eye drops, respectively. A sufficient number of subjects will be     screened and enrolled to ensure that at least 6 of 7 subjects complete each treatment in     their assigned cohort. The study will be blinded, i.e. masked by procedures that prevent     study subjects, caregivers, investigators and outcome assessors from knowing which     intervention was received. The study will be conducted in the several centers in the US.   "
11822|NCT03131154|"     A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and     efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.   "
11825|NCT03131115|"     Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people     as the sidewall of the nose collapses due to negative pressure and structural weaknesses of     the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves     anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is     another well described and universally used technique involves strengthening lateral crus of     lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the     two well known and universally used treatments to each other. Based on expert opinions these     procedures are both safe and efficient but given lack of randomized clinical trials comparing     these 2 techniques, it is difficult to extrapolate which procedure is superior.   "
11826|NCT03131102|"     In surgical patients early risk prediction of postoperative complications and organ     dysfunctions is still an important clinical challenge whereas appropriate risk predictors are     still missing. In this regard, fatigue is a complex phenomenon, is affected by many factors     and has been shown to be associated with delayed return to normal activity after surgery. The     investigators hypothesize that early tiredness (acute fatigue) assessed shortly after surgery     is associated to postoperative complications and organ dysfunctions and might be used for     risk stratification. Therefore, in this prospective, observational study the investigators     introduce and evaluate a newly developed score to assess early fatigue during the     perioperative period (Acute Fatigue Score, AFS).      The AFS and the Identity-Consequence Fatigue Scala will be used to assess early fatigue and     perioperative time courses and inter-rater-variability will be evaluated. The rating of these     two fatigue scores will be evaluated regarding the association with hemodynamic, immunologic,     endothelial, metabolic, gastrointestinal measures as well as organ dysfunction and     complications after surgery.      Furthermore, hemodynamic, immunologic, endothelial, metabolic and gastrointestinal measures     are investigated with respect to the intraoperative course and postoperative organ     dysfunction and complications. In a subgroup of patients, patients will undergo specialized     metabolic measures to investigate mitochondrial dysfunction during the perioperative period.   "
11827|NCT03131089|"     This study is prospective cohort study to investigate and identify comprehensively the     clinicopathological features and long-term outcome of young breast cancer (YBC).      We have enrolled Breast cancer patients under 40 year-old and collected their baseline     characteristics including tumor character, familiar history and other background information.     Moreover, we have collected breast cancer tissue/blood sample for analyzing genetic     characteristics, if patient agree to genetic analysis.   "
11828|NCT03131076|"     Over 500 patients were participating in the IPMN follow up between september 2014 and august     2016 at the Helsinki University Hospital. In this study we are going to determine the effects     of the IPMN surveillance on the quality of life and anxiety levels of the patients.   "
11829|NCT03131063|"     The PHARMECMO study is a pilot, prospective, pharmacokinetic study, conducted in a cardiac     surgery intensive care unit of 18 beds. Optimization of antibiotic therapy for extracorporeal     membrane oxygenation (ECMO) patients remains a pharmacological challenge. Clinical studies     suggest that individualized dosing strategies and therapeutic drug monitoring could     facilitate the achievement of adequate antibiotic concentration. The objective of this pilot     study was to observe the pharmacokinetic characteristics of commonly used antibiotics in     intensive care for patients treated with extracorporeal membrane oxygenation.   "
11831|NCT03131037|"     This is a phase I study of Gene Mediated Cytotoxic Immunotherapy (GMCI) in patients with     non-small cell lung cancer (NSCLC). The primary clinical end-point of the study is to     evaluate the safety of GMCI when combined with standard surgery for NSCLC. The primary     scientific objective is to determine the immunologic changes induced by GMCI.   "
11841|NCT03130907|"     It is well established that uncomplicated distal ureteroscopy can be safely performed without     leaving a ureteral stent. However, many urologists continue to leave ureteral stents     following uncomplicated ureteroscopy, regardless of stone location, due to concerns for     post-operative complications, patient symptoms and to reduce unplanned medical visits. There     is a paucity of data regarding the utility of stent placement for proximal ureteral or renal     stones following ureteroscopy. We have designed a prospective, randomized controlled trial to     evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in     proximal and renal stones.   "
11832|NCT03131024|"     Doxorubicin and epirubicin are part of the class of chemotherapy agents called anthracyclines     that are commonly used to treat breast cancer. Although these treatments work well against     the tumor, they are known to cause damage to the heart muscle, resulting in diminished heart     function that can be permanent, and may also damage the blood vessels and skeletal muscles.     The purpose of this study is to determine whether short-term application of these     interventions with specific timing relative to the receipt of each treatment can prevent the     negative effects of anthracycline treatment on the heart, aorta (largest artery leaving the     heart), and skeletal muscle, improve quality of life and reduce tumor size. Fifty-six early     stage breast cancer patients who will receive anthracycline treatment will be randomly     assigned to 1 of 3 groups who will: 1) perform a single 30-minute aerobic exercise session 24     hours prior to each treatment; 2) eat a diet consisting of 35% less calories for 48 hours     prior to each treatment; or 3) receive usual cancer care. Magnetic resonance imaging (MRI)     will be used to precisely measure the function of the heart, aorta, and the lower leg     skeletal muscle at rest, and again during exercise to allow detection of more subtle signs of     damage. We will also measure exercise capacity (i.e. aerobic fitness), microscopic damage to     the heart muscle cells, a marker released into the blood in response to anthracycline-related     heart damage, tumor size in patients receiving chemotherapy before surgery, quality of life     and fatigue. These measures will be performed before treatment, at the end of treatment and 1     year later.   "
11833|NCT03131011|"     A phase II prospective, randomized control trial assessing the impact of invisible ink     ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment     localization on the quality of life of breast cancer patients undergoing adjuvant     radiotherapy. The effect of tattoo type on quality of life will be measured objectively using     the externally validated body-image satisfaction (BIS) scale as the primary outcome of     interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup     using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A     sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period     of 18 months.   "
11834|NCT03130998|"     Compared to smokers who are not depressed, smokers with depression who try to quit smoking     are 10% less likely to succeed when given standard treatment. A simple program with a     detailed handout on relaxation exercises and a journal to record mood and urges to smoke when     trying to quit has been shown to increase quit success in depressed smokers by 12 to 20%.     However, it remains unclear how to best implement this knowledge into primary care settings.      Through this study, the investigators will seek to answer the following questions:        -  Does a knowledge broker communicating via generic email reminders engage clinicians to          provide patients resources for mood management more or less frequently than via          interactive technology (eKB)?        -  Which Knowledge Translation (KT) strategy used to change clinicians' behavior (emails          vs. eKB) has the greatest effect on smoking quit rates in depressed smokers?        -  What is the incremental cost effectiveness of the two KT strategies?   "
11835|NCT03130985|"     Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve     surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but     adequate risk prediction is currently impossible. This study aims to discover tissue and     circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological     processes underlying AF and are potential tools for risk stratification and prognosis or may     become future targets of therapy.      This study will be a single-center cohort study of 150 patients undergoing cardiac surgery,     which will constitute the beginning of the follow-up period. Left atrial appendages, whole     blood and epicardial mappings will be collected. Patients will be followed for 2 years with     regular holter investigations to detect postoperative and new-onset AF.   "
11836|NCT03130972|"     This study aims to identify the etiology of children with motor developmental delay, in     association with the results of magnetic resonance imaging and genetic analysis.   "
11837|NCT03130959|"     The purpose of this study is to determine the safety and effectiveness of nivolumab alone and     in combination with ipilimumab in pediatric patients with high grade primary central nervous     system (CNS) malignancies   "
11838|NCT03130946|"     Axillary lymph node status is a vital prognostic factor in breast cancer patients and     provides crucial information for making treatment decisions. Ultrasound test with subsequent     fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of     axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of     cytological test compromise the outcome the preoperative lymph node staging strategy     especially in patients with intermediate suspicious nodes. This prospective study is to     compare the performance of a crpo-assisted core biopsy with FNA.   "
11839|NCT03130933|"     Objectives: The objective of the study was to evaluate the effectiveness of a prophylactic     single preoperative dose of amoxicillin in decreasing complications after lower third molar     surgery.      Materials and methods: The sample consisted of 400 patients randomly divided in two groups     consisting of 200 patients per each group. The patients underwent third molar surgery at the     Department of Oral Surgery, Clinical Hospital Dubrava, Croatia, in the period between April     2010. and November 2016. Unlike the patients from the second group, the first group of     patients had never been diagnosed inflammation prior the surgical procedure. The main tested     groups were further divided in two subgroups (control and tested): the tested subgroup (100     patients) received a prophylactic single dose of 2 g amoxicillin an hour prior the procedure,     while the second control subgroup (100 patients) received a placebo. Complications, including     swelling, alveolar osteitis (AO), infection at the surgical site (SSI), limited mouth     opening, pain, bleeding, and increased body temperature, were evaluated postoperatively.     Evaluation was done on the first postoperative day and 7 days after surgery.   "
11840|NCT03130920|"     The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury     of remote ischemic preconditioning of the liver against local ischemic preconditioning of the     liver during human liver resections.   "
11852|NCT03130764|"     Despite aggressive surgery and chemotherapy, the risk of lung cancer recurrence remains high     in most patients. This study aims to determine if a novel immune therapy consisting of two     drugs is feasible and potentially increases the chance of cure in lung cancer patients after     surgery and standard chemotherapy. The immune-based therapy being given in this study     consists of two medications named durvalumab and tremelimumab.   "
11842|NCT03130894|"     Background: The association of trimethylamine-N-oxide (TMAO), a microbiota dependent     metabolite from dietary choline and carnitine, with type 2 diabetes was inconsistent.      Objective: The investigators planned to investigate the association between plasma TMAO and     newly diagnosed type 2 diabetes as well as whether the association could be modified by the     TMAO-generating enzyme flavin monooxygenase 3 (FMO3) polymorphisms.      Design: This is an age- and sex-matched case-control study of 2694 participants: 1346 newly     diagnosed cases of type 2 diabetes and 1348 controls. The patients of newly diagnosed type 2     diabetes were consecutively recruited from those attending for the first time the outpatient     clinics of Department of Endocrinology, Tongji Medical College Hospital, Wuhan, China, from     2012 January to December 2014. Concomitantly, the investigators recruited healthy individuals     who were frequency-matched by age (±5 years) and sex to patients from an unselected     population undergoing a routine health check-up in the same hospital. The inclusion criteria     for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (BMI)     < 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological     treatment for hyperlipidaemia or hypertension. Patients with clinically significant     neurological, endocrinological or other systemic diseases, as well as acute illness or     chronic inflammatory or infective diseases, were excluded from the study. All the     participants enrolled were of Chinese Han ethnicity. All the participants gave informed     written consent to the study and did not take any medication known to affect glucose     tolerance or insulin secretion before participation. The study was approved by the ethics     committee of the Tongji Medical College. Concentrations of plasma TMAO were measured, and     FMO3 E158K polymorphism (rs2266782) were genotyped.   "
11843|NCT03130881|"     This phase I, first-in-human dose-escalation study was conducted to determine the maximum     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),     pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.   "
11844|NCT03130868|"     The purpose of the study is characterizing changes in the microbiome of severely-injured     adult patients as they progress through stages of injury, reconstruction, and recovery from     burns.   "
11905|NCT03130075|"     Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the     scales that evaluate the selective movements of the upper limb to the evaluations will     increase the variety of evaluation methods.      The purpose of this study is to evaluate the validity and reliability of the Turkish version     of the Caregiver Functional Use Survey (CFUS)   "
11845|NCT03130855|"     This split mouth randomized control trial is designed as to compare the effectiveness of the     buccal infiltration technique with the gold standard inferior alveolar nerve block in     anesthetizing mandibular second primary molars to undergoing pulpal treatment.      patient will be videotaped during pulpal treatment of their teeth and an accessing pain will     be through an objective pain scale (SEM scale), (sound-eye-motor scale).      the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered     during injecting the local anesthetic agent in both techniques.   "
11846|NCT03130842|"     Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various     methods are available for sedation during this procedure. Because of some side effects     related to intravenous administration of sedatives, oral administration of these drugs is     under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety.     Intravenous midazolam is being used by some centers for sedation during endoscopy, but the     oral form can also be used with probably same efficacy. Hence, investigators compare the     efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this     procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral     midazolam in reducing anxiety and pain/discomfort related to the procedure.   "
11847|NCT03130829|"     Primary Objectives:      To evaluate the Quality of Life (QoL) score of adding oral Oligo Fucoidan to platinum-based     chemotherapy in comparison with placebo in subjects with Non-Small Cell Lung Cancer (NSCLC).      Secondary Objectives:      To assess the progression-free survival (PFS) and objective response rate (ORR) of adding     oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects     with NSCLC.   "
11848|NCT03130816|"     In our prior study on the therapeutic mechanism of UCB, changes in cytokine levels were     observed but the results are inconclusive and further studies on animal models and changes of     protein expression before and after UCB therapy in the clinical settings are required.      The changes in protein expression will be assessed by multiplex RT-PCR mRNA assay. Clinical     efficacy of UCB therapy will be evaluated with various functional assessment tools. Factors     regarding UCB therapy (number of transplanted cells, HLA matching status, serum level of     immunosuppressant, etc.) and patient factors (age, functional status, etc.) will be analyzed     for correlation with protein expression after UCB therapy. Several target proteins for     analysis are available. Pentraxin and toll-like receptor (TLR) 4 are receptors modulating     intrinsic immune reaction and was shown to have a significant correlation with clinical     efficacy of stem cell therapy. Ubiquitine is a regulatory protein that combines with the     target protein and affects its degradation, interaction, localization and activation. The     ubiquitine system controls total protein quantity for homeostasis and can be found in all     tissues. Deubiquitination (DUB) enzyme down-regulates this ubiquitine and is known to     modulate all cellular changes   "
11849|NCT03130803|"     Sleep and wakefulness disorders impact 50 to 70 million Americans and insufficient sleep is     epidemic with over 50% of Americans reporting less than 7 hours of sleep per night. Health     problems associated with insufficient sleep include inflammation, depression and anxiety,     diabetes, stress, drug abuse, poor quality of life, obesity, and fatigue related accidents on     the job/while driving. While the contribution of sleep to overall health, well-being, and     public safety is recognized, no established clinical biomarkers of sleep deficiency exist.     Such biomarkers would have utility as road-side biomarkers of sleepiness (e.g., drowsy     driving), monitoring on the job fatigue/fitness for duty (e.g., transportation, military ops     health care), monitoring sleep health, as well as for clinical diagnostics and measures of     clinical treatment outcomes. Thus, investigators designed a controlled laboratory     insufficient sleep protocol utilizing metabolomics to identify biomarkers of insufficient     sleep. Investigators propose to identify changes in metabolites that consistently occur     during insufficient sleep. As an exploratory outcome investigators will examine associated     changes in metabolites and cognitive performance during insufficient sleep.   "
11850|NCT03130790|"     This protocol for Varlitinib is developed for the treatment of Gastric Cancer. Varlitinib     (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of     the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor     receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by     simultaneous inhibition of these receptors. The purpose of this study is to determine the     safety and efficacy of Varlitinib in combination with mFOLFOX6 for the treatment of Gastric     Cancer. Treatment groups are Varlitinib+mFOLFOX6 and Placebo+mFOLFOX6.   "
11851|NCT03130777|"     To demonstrate the safety and functionality of the Edwards Alterra Adaptive Prestent in     conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in patients with     a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated     for treatment of pulmonary regurgitation (PR).   "
11853|NCT03130751|"     This study is the user testing phase of a mobile application intervention which will be     designed to promote positive coping skills, illness resilience, and social support, and to     serve as a complement to patient-physician interactions in adolescents and young adults (AYA)     with sarcoma. User testing will be conducted with a prototype of the app. Participants will     be AYA ages 13-25 with sarcoma (N=16). Study participation involves the AYAs downloading and     using the app for 30 days. During the 30 days, participants will interact with the app by     inputting their current mood, receiving supportive feedback from the app, reading messages,     and doing brief activities (such as relaxation activities, etc.). Participants will also     participate in an online focus group focused around the user experience. Before and after the     30 days of user testing, participants will complete a few brief questionnaires about their     behavior, how their symptoms affect their life, and how they receive support from others.     These questions will take around 20 minutes to complete at each administration.   "
11854|NCT03130738|"     The purpose of the study is to evaluate the efficacy and safety of active treatment     (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole     oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with     fungal infection (otomycosis) of the external ear.   "
12041|NCT03128216|"     Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound     guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal     hernia repair surgery. The effectiveness is defined as pain control during intraoperative and     time need to reach hospital discharge criteria in the post-operative period.   "
11855|NCT03130725|"     Dental caries, is one of the major public health problem in Pakistan. Dental sealants are     known cost effective preventive measure of dental caries as compared to other preventive     measures. Resin based sealants, is a proven treatment of pits and fissure sealants but     retention is still problem. This trial will assess the use of amalgam sealants as an     effective and retentive preventive measure in preventing dental caries in children as     compared to the standard resin-based sealants. The findings of this randomized controlled     trial will be used to raise awareness among the health care professionals, help them to     choose amalgam sealants as an effective caries prevention method thereby reducing the burden     of cost as amalgam is cheaper material compared to resin-based sealants.      The research question Is there any difference in the six months retention of bonded amalgam     sealants compared to resin-based sealants among 12 to 16 years old children in Karachi   "
11856|NCT03130712|"     In this study, CART cells are targeted to GPC3 by intratumor injected that we hope by this     means could improve the local CAR-T cell numbers, meanwhile reduce the potential side     effects.   "
11857|NCT03130699|"     This study will compare Dulce Digital (i.e., the investigators' proven-effective combination     of one-size-fits-all educational text messages and nurse monitoring of patient-transmitted     blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile     health) intervention that is tailored to individuals' needs and behavioral progress, in     improving diabetes clinical control, adherence, and patient-provider communication in     Hispanics - an at-risk, understudied population that experiences disparities in diabetes     prevalence and outcomes. These striking disparities in the growing and aging US Hispanic     population have taxed the US healthcare system, while significantly reducing quantity and     quality of life for millions of individuals. By offering an innovative, scalable, and     sustainable approach that seamlessly integrates several mHealth technologies into existing     primary care team processes to improve the health of Hispanics (and eventually, other     at-risk, underserved groups), DD-Me has strong potential to significantly impact public     health.   "
11858|NCT03130686|"     The purpose of this study is to measure the blood pressure level of the patients, using a     cuff ranged 17 - 50 cm.   "
11859|NCT03130673|"     An observational study using the information records at the Hospital Regional Rafael     Hernandez, in Chiriqui, Panama, that will help to analyze the epidemiology and early     treatments results of hip fracture patients treated in this institution.   "
11860|NCT03130660|"     We plan to compare single person short axis view with two person long axis view   "
11861|NCT03130647|"     Transcranial focused ultrasound (tFUS) is a form of neuromodulation that uses a single     element transducer to produce highly focused low-intensity acoustic energy that can be used     to affect cortical excitability in humans.   "
11862|NCT03130634|"     Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the     intestinal side effect of the patients undergoing FOLFIRI chemotherapy.   "
11863|NCT03130621|"     Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors     with a family history and specific clinical pathological types，we establish a complete family     and follow-up system，in order to improve the screening criteria of Chinese hereditary upper     gastrointestinal tumors and carry on primary prevention of disease.   "
11864|NCT03130608|"     Individuals with chronic liver disease develop significant muscle wasting that remains     post-liver transplant. The transplant surgery additionally challenges respiratory mechanics.     Respiratory muscle strength has been measured to be impaired in individuals post liver     transplant. This study proposes an 8 week intervention designed to increase respiratory     muscle strength and pulmonary function that we hypothesize will correlate to improved     functional performance and quality of life post-liver transplant.      Pre-test post-test design, that will randomize subjects into an experimental group that will     receive the inspiratory muscle strengthening exercise in addition to usual post-liver     transplant care and a control group that will only receive the usual post-transplant care.      Up to 50 subjects will be recruited from the Post-Liver Transplant Outpatient Clinic at the     Miami Transplant Institute.      The subjects will have repeated measurements of respiratory muscle strength, pulmonary     function, functional mobility performance, and quality of life at baseline, 4 weeks, and 8     weeks.   "
11865|NCT03130595|"     WestPORTS will recruit a randomly selected population consisting of 25% of all individuals     with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient     neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month     period between Sept 2016 and April 2018.      Baseline clinical and demographic data will be collected along with a 6 x 24h accelerometry     recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will     be made with regular intervals of up to 2 years as long as subjects are alive and willing.   "
11878|NCT03130426|"     The purpose of the study is to determine whether in patients with early type 2 diabetes, a     short-term intensive metabolic intervention comprising iGlarLixi, metformin, and lifestyle     approaches will be superior to standard diabetes therapy in achieving sustained diabetes     remission.   "
11866|NCT03130582|"     patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic     stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d     intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48     hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs.     Peripheral blood counts were performed daily for all patients following the initiating of     rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L     with blood cell The harvested cells reached at least 2*108/kg for mononuclear cells and/or     2*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen     in liquid nitrogen.Auto-PBSCT   "
11884|NCT03130348|"     This phase II trial studies how well ibrutinib with or without bortezomib and dexamethasone     works in treating patients with immunoglobulin light chain amyloidosis that has come back     after a period of improvement or that does not respond to treatment. Ibrutinib and bortezomib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving ibrutinib with or without bortezomib and dexamethasone may work     better in treating patients with relapsed or refractory immunoglobulin light chain     amyloidosis.   "
11867|NCT03130569|"     This study will have two phases, with an added usability test after Phase I and before Phase     2. Phase 1: Cognitive Interviews of materials in Spanish. Phase 2: Personalized Genomic     Testing for Skin Cancer (PGT-SC). The overarching goal of this study is to learn more about     how to maximize the availability, comprehension and appropriate uptake of personalized     genomics among different populations in New Mexico. Primary Care patients will be recruited     in their primary health clinic to complete surveys about their understanding and beliefs of     skin cancer and behaviors that might help prevent skin cancer. 6 out of every 7 patients will     then be asked to go to a website to learn more about skin cancer risk. Once participants have     completed the education modules on this site, participants will be given the option to     request and complete a skin cancer genetic testing kit. All participants will be contacted     again after three months to complete a follow-up set of surveys about skin cancer.   "
11868|NCT03130556|"     This study is intended to establish the bioequivalence (BE) of single 100 mg doses of     glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation     compared to the Phase 2 formulation.   "
11869|NCT03130543|"     Infants often present to the hospital with episodes of coughing, choking, gagging, change in     muscle tone, and/or change in skin color, known as brief resolved unexplained event. Many     studies have tried to address why infants have these symptoms and if there is a way to     prevent them from happening again. Currently, there is no clear agreement on the most common     cause of these symptoms or how to prevent them. Some studies have suggested that     gastroesophageal reflux can cause these symptoms. The investigators are conducting a study of     infants who are admitted to Boston Children's Hospital with episodes of coughing, choking,     gagging, change in muscle tone, and/or change in skin color, symptoms that could be reflux.     The investigators want to determine if these symptoms can be prevented by changing the way     infants are fed, either by giving them a formula to treat reflux or by thickening their feeds     to treat reflux. The goal of the study is to determine if different types of feeding     interventions prevent infants from coming back to the hospital.   "
11870|NCT03130530|"     The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical     device that is available for distribution in the EU (European Union) under CE Mark for use in     general surgery, thoracic surgery, gynecological surgery and urological surgery. The main     research question is to assess, from a retrospective poit of view, the safety and feasibility     of this new robotic platform in the colorectal surgery.   "
11871|NCT03130517|"     hemolytic disease of newborn is an important cause of hyperbilirubinemia with significant     morbidity and mortality in neonatal period. intravenous immunoglobulin has widely used in     management of hemolytic disease of new born   "
11872|NCT03130504|"     Antepartum hemorrhage is defined as bleeding from or within the female genital tract,     occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage     occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity     and mortality worldwide.      Placenta previa is a placenta inserted wholly or in part into the lower segment of the     uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of     the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree     if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal     os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal     mortality of 8.1% in the developed world and much more in developing countries.      Many studies in literature proved the positive correlation between the Placenta previa and     preterm uterine contractility and also reported that large proportion of women who have     Placenta previa associated with vaginal bleeding will have subclinical uterine contractions     before the onset of evident vaginal bleeding.      There are many tocolytic agents may have a role in conservative management of Placenta previa     such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation     of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal     morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized     placebo-controlled trial found a significant reduction in recurrent preterm birth before 37     weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus     54.9%).   "
11873|NCT03130491|"     The primary objective is to evaluate the performance and the treatment effect of the use of     the Emblok embolic protection system use during transcatheter aortic valve replacement with     respect to procedure-related cerebral embolic burden as determined by DW-MRI.   "
11874|NCT03130478|"     This is an observational, retrospective, non-interventional study that will include     schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related     hospitalisation at least 6 months before data collection and in a real clinical practice     setting.   "
11875|NCT03130465|"     This is an observational, non-interventional study that will include two cohorts of patients     with schizophrenia who initiated maintenance treatment during a schizophrenia-related     hospitalisation: patients who initiated maintenance treatment with aripiprazole once-monthly     and patients who initiated maintenance treatment with any daily oral atypical antipsychotic.   "
11876|NCT03130452|"     The purpose of this study was to evaluate the efficacy and compliance of tailored therapy     which using the polymerase chain reaction for point mutation of clarithromycin, compared to     concomitant therapy, in patients without history of H. pylori eradication.   "
11877|NCT03130439|"     This research study is studying a drug called Abemaciclib as a possible treatment for have     metastatic triple-negative type of breast cancer.   "
12455|NCT03122704|"     This is a cross - sectional study to determine the prevalence of GBS infection and associated     factors in preterm labor women conceived through ART.      221 subjects will be involved.   "
11879|NCT03130413|"     The aim of this randomized study is conducted is to evaluate the performance and safety of     air-Q intubating laryngeal airway as primary airway device in various short surgical     procedure in children compared to Ambu® AuraGain™ Laryngeal Mask. Current Supraglottic airway     devices (SADs) available in are classic LMA (cLMA), proseal LMA (pLMA), supreme LMA (sLMA)     and the newer is Ambu® AuraGain™laryngeal mask. As variety of newer SADs for children have     emerged since their introduction in clinical practice, hope the outcomes of this study it     help advancing our knowledge and acumen in selecting appropriate devices for paediatric     population.   "
11885|NCT03130335|"     Knee osteoarthritis (OA) is a leading cause of disability. The objectives of treatment are to     reduce pain, improve function, and slow down further breakdown of the knee. Recently,     research on nonsurgical treatment options for knee OA has increased significantly. One     potential treatment of interest is the use of stem cell injections. Stem cells are one's own     cells that have the ability to divide into other types of cells, and may cause regrowth of     cartilage when injected into the knee. There have been few, but promising, studies that show     improvements in pain and function with stem cell injections in those with knee OA. Therefore,     more research is needed to identify patients who might benefit from this injection. This     pilot study will look at changes in pain and function for 20 patients at 1, 3, 6, and 12     months after a stem cell injection into the knee. Patients will also undergo magnetic     resonance imaging at 6 months and 12 months following the injection.   "
11886|NCT03130322|"     This study is designed to determine the neural networks underlying the sleep-related motor     consolidation process following motor imagery practice. While beneficial effects of sleep are     expected for sequential movement but not for adaptation motor tasks, the corresponding     neuroanatomical correlates have not yet been investigated when participants acquired the     motor tasks through mental practice. Data should substantially promote how designing motor     imagery interventions targeting (re)learning and/or motor recovery in patients suffering from     motor disorders.   "
11887|NCT03130309|"     The unicompartmental knee prosthesis has become a routine procedure. Survival rate of over     90% after 10 years are generally reported. However, complications and reoperation may still     occur for many reasons, and some of them may be related to component design: loosening     (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... .     Therefore, new designs can, at least in theory, improve the results of conventional models.      In this study, the investigators want to compare retrospectively data concerning survival     rates of patients wearing unicompartmental knee prosthesis with mobile plate for over 10     years, with the ones published in the literature for conventional fixed-bearing prostheses     and mobile-bearing prostheses   "
11888|NCT03130296|"     This non-interventional study aims to determine whether there is a correlation between the Fc     receptor polymorphism (FcR) and the course of the disease following HIV infection.   "
11889|NCT03130283|"     The project has a threefold aim: (i) Assessment of Home Hospitalization and Early Discharge     (HH/ED) deployment at Hospital Clinic over a period of 10 years (2006-2015) as a preliminary     analysis fo the second aim (ii) Large scale deployment of HH/ED and Transitional Care     services; and, (iii) Population-based study on cost-effectiveness of integrated care services     in the urban healthcare sector of Barcelona-Esquerra (540.000 inhabitants). The central     hypothesis is that the approach will show safety and effectiveness with high level of user's     acceptance and health value generation leading to sustainability of the service.The     preliminary data indicate that HH/ED shows potential to strengthen care coordination between     highly specialized hospital-based care and home-based services involving different levels of     complexity. The need for appropriately designed transitional care services has been     identified as the best option, not only for an efficient transference of patients from     hospital to the community after hospital discharge, but as a way to overcome well identified     limitations for generalization of community-based integrated care services.      AISBE is a population-based health initiative aiming at deployment of integrated care in one     urban healthcare sector (Barcelona-Esquerra, 540.000 inhabitants) in the city of Barcelona.     Within this initiative, the HH/ED program carried out by Hospital Clinic provides home-based     hospitalization. Moreover, the program aims to implement transitional care strategies for     optimal discharge.      The current document describes three studies: (Study 1) Analysis of the period 2006-2015;     (Study 2) Program-based analysis of Home Hospitalization/Early Discharge (HH/ED) , and,     (Study 3) Population-based analysis of cost-effectiveness of AISBE-based services. Study 2 is     a program-based analysis of Home Hospitalization/Early Discharge (HH/ED). A     quasi-experimental design. That is, a non-randomized intervention group (integrated care)     will be compared with a control group (usual care) using propensity score matching wherein     age, gender and health risk scoring will be main matching variables. The population-based     evaluation will be done using registry data obtained from the Catalan Health Surveillance     System (CHSS).      The protocol evaluation follows a Triple Aim approach considering pre-defined outcome     variables for: a) health and well-being, b) experience with care, and c) costs.   "
11890|NCT03130270|"     The study is to evaluate the efficacy and safety of Apatinib for later treatment of     patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal     carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and     locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and     survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of     drug safety.   "
11976|NCT03129139|"     A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and     Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off     schedule in patients with Advanced Solid Tumors   "
31093|NCT02878759|"     The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis     and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic     disease.   "
11891|NCT03130257|"     Hypertension is usually diagnosed at a clinic or doctor's office when a patient has blood     pressure (BP) that is high for several measurements. However, about 30 percent of patients     with high BP in clinics have normal BP outside of clinics. This is called white-coat     hypertension. Correct diagnosis of hyper-tension is important to prevent strokes, heart     attacks, and heart failure but also to avoid making people worry or take medicines when they     don't need to.      To avoid misdiagnosis of hypertension, the US Preventive Services Task Force (USPSTF), which     makes national recommendations about disease screening, recommends people should have 24-hour     BP ambulatory monitoring (i.e., an arm cuff and BP monitor worn for 24 hours, with     measurements taken every 30 minutes during the day and every 60 minutes at night), with home     BP monitoring over several days as an alternative. However, most patients have never heard of     24-hour BP monitoring, and physicians rarely order it. Physicians sometimes use home BP     monitoring, but not according to recommended guidelines. BP kiosks, for example at drug     stores, offer another option. Newer models are accurate and easy to use.      BP-CHECK will identify patients, ages 18 to 85, with high BP at their last clinic visit and     invite them to a screening visit. Patients with high BP at the screening visit (510 patients)     will be randomized and assigned to 1) clinic BP, 2) home BP, or 3) kiosk BP diagnostic groups     for confirming a new diagnosis of hypertension. The clinic BP group will have BP measured at     two clinic visits. The home BP group will measure BP two times, twice a day, for five days.     The kiosk BP group will measure BP three times on three separate days at a kiosk at their     clinic or nearby drugstore. Participants will complete their diagnostic tests over three     weeks. They will then be asked to complete 24-hour BP monitoring. Participants will complete     surveys at baseline prior to randomization, after diagnostic tests, and at six months.      Hypothesis 1: Compared to the reference standard (24-hour BP), home BP and kiosk BP will be     more accurate than clinic BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results     concordant with reference standard results will prefer home or kiosk to clinic and 24-hour     BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results concordant with reference     standard results will prefer home or kiosk to clinic and 24-hours BP.   "
11892|NCT03130244|"     Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.   "
11893|NCT03130231|"     This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD)     in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in     plasma and cerebrospinal fluid were compared between the POD and non-POD groups.   "
11894|NCT03130218|"     Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea     in the bariatric surgery patient population.   "
11904|NCT03130088|"     This study will evaluated the epidemiology and the outcome of patients suffering     out-of-hospital cardiac arrest in 27 european nations. The special focus in the EuReCa TWO     study is on bystander CPR.   "
11895|NCT03130205|"     The biology of pancreatic neuroendocrine tumors can change during the disease course. This     evolution of disease can manifest through increases in tumor proliferation rate, resistance     to medical therapy and/or a change in tumor hormone secretion. This study aims to     characterize how the biology of pancreatic neuroendocrine tumors change over time, measured     by; patient symptoms, biochemistry, contrast enhanced computed tomography, FDG-PET and core     needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation).     Uptake on 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction     of patients with spatial heterogeneity in FDG uptake as well as metachronous changes in all     collected data will be documented. Biomaterial from whole blood and core needle biopsies will     be characterized on the molecular level, and those findings will be integrated to the above     specified clinical parameters.   "
11896|NCT03130192|"     Worldwide, non-small cell lung cancer (NSCLC) is one of the most common causes of cancer     mortality. Also, the first leading cause of death is lung cancer in Taiwan 2012. Most     patients are diagnosed at advanced stages and their median survival with supportive care is     only 3-6 months. The common regimens used on advanced NSCLC treatment consists of     platinum-based doublet chemotherapy, the survival benefit of which is able to extend the     survival to approximately 10 months. However, disease and treatment-related toxicities in     cancer patients may result in fatigue and interfered quality of life (QoL). According to the     others reports, eight QoL areas including physical functioning, fatigue, pain, and appetite     loss have been showed a statistically significant association with survival rate of NSCLC     patients.      Cancer-related fatigue (CRF), an indicator of QoL, has been reported as the most frequent and     distressing toxicity of lung cancer chemotherapy. Proposed criteria for CRF have been adopted     for inclusion in the International Statistical Classification of Disease and Related Health     Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth     researches on CRF are needed in Taiwan.      In addition, electrolyte disturbance like hyponatremia has been reported to be counted as one     of the many contributing factors for fatigue in palliative care patients and associated with     poorer overall survival rate (OS) in lung cancer. Thus, the correlation between CRF and     electrolyte possibly would be a strong link for physician to improve the QoL and survival     rate of NSCLC patients.      The objective of this observational study is to evaluate the correlation between CRF,     survival and physiological factors in NSCLC patients under chemotherapy. The study will     compare the effect of QoL and CRF on survival with or without CRF treatment and investigate     the correlation between the variation of CRF and physiological factors which have been     examined and recorded on medical record under clinical practice. These results will supply     physicians with more understanding about CRF, and help them to enhance the quality on lung     cancer care to being perfected in the future.   "
11897|NCT03130179|"     This is a research study to verify the same effectiveness and safety profile for the test     product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint     lozenge (reference product), in a standardized mode. This verification is done in a so-called     bioequivalence study, which means that the same amount of the same active substance     (nicotine), in the same dosage form, for the same route of administration, and meeting the     same or comparable standards is performed.      During the study visits, blood samples will be drawn to measure the level of the substance in     the blood to verify that the two products are comparable. Tolerability of the treatments will     be evaluated based on reported and observed adverse events.   "
11898|NCT03130166|"     Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as     minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new     technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is     less invasive and thereby has the potential to improve the postoperative course of right     colonic cancer patients.      The objective of this study is to compare robotic right colectomy with either ICA or ECA in a     randomized controlled setting.   "
11899|NCT03130153|"     There is no evidence based guidelines on using saline rinses for post extraction oral care     among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to     orally administered analgesic is questionable.   "
11900|NCT03130140|"     The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for     estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a     19-gauge needle. How it compares to the conventional technique of tissue acquisition during     EUS-FNA is uncertain.      The objective of this study is to evaluate the quantity and quality of tissue, and the     diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic     analysis.   "
11901|NCT03130127|"     Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver     cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard     approach of terlipressin. It remains unclear about whether or not continuous infusion of     terlipressin should be considered.   "
12150|NCT03126721|"     This is a drug interaction study to evaluate the PF-06751979 at steady state on the     pharmacokinetics of oral midazolam single doses in fixed sequences including single dose     midazolam alone in period 1 followed by multiple doses of 100 mg PF-06751979 once a day for     11 days with single dose midazolam co-administered on Day 10 in period 2   "
11902|NCT03130114|"     Although the current World Health Organization (WHO) recommended management package for acute     diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in     diarrhoea associated mortality, over half a million children continue to die annually as a     result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the     90 days following an episode of acute diarrhoea appear at least as high as mortality that     occurs during the acute episode. The long-term benefits of antibiotic administration may     result from direct antimicrobial effects on pathogens or from other incompletely understood     mechanisms including improved nutrition, alterations in immune tolerance or improved enteric     function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children     with severe disease may offer the opportunity to significantly reduce diarrhoea associated     deaths in the 90 days following presentation for acute diarrhoea and may also improve growth.      The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered     in a specific, targeted fashion to young children (< 2 years of age) at high risk of     diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled     trial. The study will evaluate the ability of the intervention to reduce mortality within 90     days of the acute diarrhoeal episode, and improve nutritional status over the same period.   "
11903|NCT03130101|"     The purpose of this study is to compare the time spent in glucose target range (4.0-10.0     mmol/L) during exercise and in recovery using three different basal insulin management     strategies for prolonged aerobic exercise: A) pump suspension for the duration of the     activity, starting at the onset of exercise; B) A 50% basal rate reduction, performed     90-minutes in advance of exercise for the duration of the activity; and C) An 80% basal rate     reduction, performed 90-minutes in advance of exercise for the duration of the activity.   "
11906|NCT03130062|"     To analyze the effectiveness of 16-week resistance exercise in daily motor behavior and     functional fitness in women with Primary Sjögren's Syndrome. The present study presents as     hypothesis that a supervised resistance exercise program is effective and safe in improving     the functional fitness and quality of life of patients with Primary Sjögren's Syndrome,     making them more physically active, contributing positively to the capacity to perform daily     life activities as household and / or professional tasks.   "
11907|NCT03130049|"     The study aims to investigate the effect of the popliteal plexus block (PPB) on postoperative     pain in patients undergoing anterior cruciate ligament (ACL) reconstruction.   "
11908|NCT03130036|"     This is a single center imaging study that will recruit 30 participants who are enrolled in     the Brain Energy And Memory study (BEAM) protocol. This cohort of patients, aged 50-85, will     receive a maximum of 3 [11C]Acetoacetate (AcAc)/[18F]Fluorodeoxyglucose (FDG) PET scans over     18 weeks as part of this supplemental trial.   "
11909|NCT03130023|"     Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve     using oximetry sensor. In this study, we will investigate the correlation between ORI and the     partial pressure of arterial blood oxygen (PaO2) in children.   "
11910|NCT03130010|"     In the present study, the investigators evaluated whether nefopam 20 mg reduce the     catheter-related bladder discomfort in patients undergoing foley catheter insertion   "
11911|NCT03129997|"     The objective is to evaluate, in healthy, eutrophic women, if gluten intake influences on     body weight, basal metabolic rate and macronutrient intake. In a crossover double masked     model, 30 volunteers will be randomized into two groups, half of them will initiate the     experiment by taking 2 placebo muffins daily for 3 weeks (Placebo phase) and the remnant     volunteers will take 2 gluten muffins for 3 weeks (Gluten phase). After one day of wash     out, the volunteers will be transferred for the other phase to complete 3 more experimental     weeks.   "
11912|NCT03129984|"     The primary objective of this study is to determine the technical failure and inconclusive     test rates when using the Brizzy device for mandibular movement tracking.   "
11913|NCT03129971|"     To objectively analyze the effectiveness of platelet-rich plasma (PRP) combined with     conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures.   "
11914|NCT03129958|"     This study is a cross sectional study conducted to find out the Correlation between neck pain     and postural abnormalities among female office workers at University of Dammam by objective     assessments methods.      Eligible participants will sign the consent form followed by filling up demographic data,     visual analog scale & neck disability index.      After that, Forward Head posture and Thoracic Kyphosis posture will take place by valid and     reliable methods.   "
11915|NCT03129945|"     The purpose of this research study is to determine the best medication to stop preterm labor.     Recent studies have identify nifedipine and indomethacin as the two medications that are most     likely to delay delivery for 48 hours, decrease maternal side effects and decrease some     complications related to preterm delivery to the neonate. Both of these medications are     commonly used to stop pre-term labor, therefore it has become our institution's standard to     use these two medications in the setting of preterm labor. There have been limited studies     comparing these two medications directly.      A total of 450 participants will be asked to participate across all study sites.   "
11916|NCT03129932|"     This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in     women with obesity, a possible influence of wheat gluten on food choices, body weight,     resting metabolism and circulating inflammation markers and adipokines. The volunteers will     be randomized into two groups, half of them will initiate the experiment by taking 2 placebo     muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins     containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th     experimental weeks will be evaluated body weight, body composition, lipid profile, glucose,     insulin, leptin, adiponectin, and inflammatory markers.   "
11917|NCT03129919|"     It is intended to evaluate changes in arch dimensions and incisor inclination as well as     changes in the WALA Ridge in no extraction patients treated with interactive self-ligating     brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and     leveling. For this, study models and profile radiographs taken before the start of treatment     and at the end of the alignment and leveling phase will be evaluated. The parameters to be     measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA     ridge analysis   "
11918|NCT03129906|"     The aim of this study is to evaluate the impact of gluten-free diets on symptoms and     inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as     to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM.     Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th     week, they will receive placebo capsules for 7 days and after washout, capsules containing     gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to     evaluate the presence of NCGS in the beginning, 8th week and 10 week.   "
11919|NCT03129893|"     Ventilator associated pneumoniae (VAP) occurs in 9-27% of all intubated patients and is     associated to an important morbidity and mortality. It is a serious complication among     neonates and pediatric patients after cardiac surgery accounting for 6.8 - 32.2 % of     health-care associated infections. It has a large impact on morbidity, survival, hospital     costs and duration of neonatal and pediatric intensive care unit stay (PICU). Ventilator     associated tracheobronchitis (VAT) is common in adults and it has been described as a risk     factor for the development of VAP. Studies have shown that treatment of VAT is associated     with a lower rate of VAP and a lower mortality in adult critically ill patients. VAT has also     been described in premature infants and children but it has been less studied than in adults.      Recently the Centers for Disease Control and Prevention (CDC) rolled out new surveillance     definitions for patients receiving mechanical ventilation that promise to dramatically     improve hospital's capacity to track clinically significant complications in this population.     These new surveillance definitions were designed to be more objective and to render the data     easier to collect and verify. The terms include ventilator-associated condition (VAC) and     infection-related, ventilator-associated complication (IVAC). Studies in adults demonstrated     that the VAC assessment was faster, more objective, and a superior predictor of outcomes.     However, this approach has not yet been applied systematically to infants and children.      For more than 50 years, uncuffed tracheal tubes have been commonly used for intubation in     children under 8 years of age because of the anatomy of the pediatric larynx and the fear     (based on case reports and scruples) that the cuff will cause airway mucosal injury, leading     to subglottic stenosis. However, since 2009, it is registered and available a new cuffed     tracheal tube (TT) (Microcuffw PET; Kimberly Clark, Health Care, Atlanta, GA, USA) with an     anatomically designed high volume - low pressure tube cuff, with a recommendation chart for     tube size selection has recently become available for pediatric anesthesia.      Weiss and colleagues enrolled 2246 patients in a randomized multi-centre trial and reported     no increase of risk for post-extubation stridor with the use of the new microcuffed.      Considering that microaspiration of contaminated oral secretions is one of the mechanisms     leading to VAP and VAT, the use of cuffed TTs may be beneficial in VAP prevention as the     superior tracheal seal may decrease the incidence of micro-aspiration. However, no study     evaluated the incidence of VAP with the use of cuffed tracheal tubes is published since now.      Despite of these new evidence, the use of uncuffed tube in neonatal and pediatric critical     care still remain very common to minimize minor complications (i.e. mucosal damage due to the     cuff), and consequently the use of cuffed or uncuffed tubes is equally recommended.      The management of anesthesia according to standards procedures of the Bergamo anesthesia     department is shifting from the uncuffed tubes only to microcuffed tubes, and it is aim of     the present study to monitor this transition measuring the performance of the two TTs in     terms of incidence of VAP and VAT (according to the CDC old definition) and in term of     incidence of VAC and IVAC (according to CDC new definition).   "
11920|NCT03129880|"     The purpose of this study is to determine if there are differences in treatment outcomes     between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive     voice therapy, consisting of 4-6 therapy sessions performed within one day.   "
11928|NCT03129776|"     The purpose of this study is to image tumour lactate in study participants with locally     advanced cervical cancer. Our hypothesis is that lactate content in cervical tumours, as     measured by hyperpolarized 13C Magnetic Resonance (MR) imaging, will correlate with     diffusion-weighted MRI and 18FDG-PET (fluorodeoxyglucose-positron emission tomography).     Furthermore, lactate imaging will potentially provide additional and more specific     information regarding the metabolic activity of cervical tumours, thereby identifying regions     of radiation resistance and guiding radiation treatment and brachytherapy.   "
11929|NCT03129763|"     The purpose of this study is to optimize the expansion pressure by compare different capsule     pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY     Angiography.   "
12042|NCT03128203|"     To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state     functional connectivity in healthy males.   "
11921|NCT03129867|"     Ticagrelor 90 mg twice daily treatment is recommended for 12 months in patients with acute     coronary syndrome (ACS) and in patients undergoing coronary revascularization and     conservative strategies. Recent data from the PEGASUS-TIMI 541 trial have shown that     long-term treatment with ticagrelor reduced the risk of major cardiovascular adverse events     (MACE) in stable ambulatory patients with a history of myocardial infarction. Based on these     data, prolongation over 12 months of ticagrelor therapy could be indicated in selected     patients; even if with such a prolongation some adverse effects on the treatment could be     observed. In the PLATO2 trial, where median duration of exposure to the study drug was 277     days, the suspension of ticagrelor therapy was 7.4% in ticagrelor versus 6% in patients     receiving clopidogrel ( P <0.001). Ticagrelor treatment interruption was mainly driven by     non-serious adverse events occurring mainly shortly after randomization. For patients after     the first year of treatment, the subsequent rate of interruption was low. These data     demonstrate that adverse events considered not serious by traditional trial criteria may     have an effect on quality of life and, therefore, can cause treatment interruption; The     phenomenon emphasizes at the same time the importance of patient education and advice on     timing and the nature of adverse effects in order to improve adherence. Patients in the real     world may show a premature suspension rate of the drug even higher than in clinical trials.     However, data from real-world patients is scarce.   "
11922|NCT03129854|"     Patients with primary diagnosed metastatic prostate cancer are randomly divided into two     groups. One group receive standard of care ADT continually. Another group receive ADT plus     prostate cryotherapy. Patients are followed up until their death or withdraw from this study     due to other reasons. The primary endpoint of this study is prostate cancer Progression-Free     Survival. The secondary endpoint is overall survival, prostate cancer specific survival and     health-related quality of life.   "
11923|NCT03129841|"     The aim of the present study is to test whether late eating dinner could affect the amount of     weight loss in healthy obese women in a weight-loss program.   "
11924|NCT03129828|"     The ImbruVeRCHOP-Trials is an Investigator-initiated, single-arm, multi-center, prospective,     open phase I/II trial to evaluate the efficacy and feasibility of Ibrutinib and Bortezomib in     the therapy of higher-risk DLBCL patients of different molecular subtypes and to correlate     outcome with clinical, molecular and imaging-guided response parameters. The protocol     includes a safety run-in phase, i.e. the phase I part of the study, to uncover unexpected     toxicities that may arise in the context of Ibrutinib and Bortezomib co-administered with the     R-CHOP backbone. The safety run-in phase is followed by the phase II part of the trial. About     60 patients will be included over 3 years. Additional 8-11 German university centers will     participate in this trial. The study treatment includes a pre-phase therapy with Prednisone     and 6 cycles of a combined immuno-chemotherapy with the anti-CD20 antibody Rituximab together     with 6 cycles of a chemotherapy consisting of Cyclophosphamide, Doxorubicin, Vincristine and     Prednisone plus Bortezomib and Ibrutinib followed by two additional 3-week cycles of     Rituximab. Secondary endpoints are the predictive power of subtypes (such as     GCB/ABC-cell-of-origin), markers of minimal residual disease over time and     during-the-study-determined markers (e.g. gene signatures) to identify patients who benefit     from this treatment addition.   "
11925|NCT03129815|"     The failure of extubation in pediatric resuscitation is most often described as the need for     reintubation within 48 hours after extubation. The failure rate of extubation in pediatric     intensive care varies in the literature there is between 4 and 22% failures. These failures     result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged     residence time. The extubation is codified in adult resuscitation and tends to be     increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre,     a extubation protocol already exists for some time, and was prepared to go. the current     literature data. It allows the harmonization of practices in service (previously left to the     discretion of each doctor).      The investigators are looking to see if the protocol used systematically in the service     enables a reduction in the incidence of occurrence of failures of extubation.   "
11926|NCT03129802|"     The failure of extubation in pediatric resuscitation is most often described as the need for     reintubation within 48 hours after extubation. The failure rate of extubation in pediatric     intensive care varies in the literature there is 4 to 22% failure. These failures result in     increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time.     Some risk factors are well defined in the literature as the duration of intubation, ENT and     neurological history, the persistence of a respiratory disease, a high level of sedation.     Other factors are more controversial as age, ventilatory parameters just before extubation     before extubation blood gases, the interest of a leak test.      Also pediatric populations are extremely heterogeneous, so the investigators would like to     highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support     these high-risk children.   "
31131|NCT02878265|"     The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and     multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity   "
11927|NCT03129789|"     Monitoring fluid balance is crucial in the care of critically ill children. There are several     reasons urine output could be decreased. For example, the bladder could be empty because the     patient isn't making urine due to dehydration, or the bladder could be full but the patient     unable to urinate due to obstruction of the bladder outlet. It is prudent to distinguish this     difference in the care of Pediatric Intensive Care Unit patients as the potential     interventions vary and none is without potential drawbacks if used inappropriately. At     present, there is no standard way to determine whether an oliguric patient has a bladder that     is under- or over-filled. Bedside ultrasound is safe, non-invasive, painless, and relatively     quick and can help assess bladder volume at the time of noted oliguria. Several studies in     pediatrics endorse the use of ultrasound to approximately measure urine volume. Pediatric     residents are frequently asked to manage patients' oliguria in the Pediatric Intensive Care     Unit, however, they are not currently being trained how to use ultrasound to measure bladder     volume. The investigators hypothesize that following a structured learning plan, by the end     of their one-month Pediatric Intensive Care Unit rotations, pediatric residents will be able     to independently and accurately measure bladder volume by ultrasound. Volumetric bladder     ultrasound is an easily mastered bedside imaging technique. Its implementation could     positively affect care of the critically ill infant or child.   "
11930|NCT03129750|"     The study is aimed at collecting preliminary safety and efficacy data related to the use of     Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral     Artery (SFA) ischemic vascular disease in patients presenting with long lesions.      The present clinical evaluation is intended as a prospective observational data collection of     patient treatment in full accordance with institution standard practice and utilizing an     approved (CE marked) DCB currently available on the market.   "
11931|NCT03129737|"     Patients elected to undergo mitral valve surgery (either repair or replacement) with less     equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at     preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion     and exclusion criteria will be included in the study and assigned to elective mitral valve     replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion,     using a blocked randomization scheme balanced within center.   "
11932|NCT03129724|"     Describe in patients with metastatic kidney cancer treatment modalities with the type     sequences: TKI - mTORi - Axitinib or VEGF mAb - mTORi - Axitinib.   "
11933|NCT03129711|"     The most frequent reason for failure of laminate veneers made of glass ceramics (feldspathic,     leucite based and lithium silicate based ceramics) was fracture of the ceramic, Therefore,     ceramic materials that have higher fracture resistance, especially for patients suffering     from abnormal occlusion, are needed.   "
11934|NCT03129698|"     52 patients with extensive-stage small-cell lung cancer and without progression after     completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.   "
11935|NCT03129685|"     Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large     hepatocellular carcinoma: single center non-randomized trial.   "
11936|NCT03129672|"     The study show the clinical results of limb salvage for primary malignant bone tumor of the     distal tibia using block excision of the tumor and reconstruction with allograft arthrodesis     with different methods of fixation (plates or intramedullary nail system)   "
11937|NCT03129659|"     Current evaluation of patients suspected of non-ST-elevation acute coronary syndrome is     greatly dictated by the results of high-sensitivity troponins. In a substantial number of     patients this approach does not provide a conclusive work-up. Patients typically present with     slightly elevated high-sensitivity troponins without significant changes during serial     sampling and no other clinical clues that can aid in determining the etiology of their chest     pain complaints. Uncertainty remains about the optimal diagnostic management of these     patients and they are often admitted to undergo invasive angiography. Coronary CT angiography     can improve efficiency of clinical care in these patients by reducing unnecessary hospital     admissions and invasive angiography. In this study, the investigators will investigate     whether a diagnostic strategy comprising of early coronary CT angiography is more clinically     efficient than standard optimal care in patients with an inconclusive work-up for     non-ST-elevation acute coronary syndrome.   "
11938|NCT03129646|"     This is an open label, Phase III, randomized, controlled, parallel arm multicentre     non-inferiority clinical trial to compare the efficacy and safety of two combination regimens     of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult     and children VL patients in Eastern Africa.   "
11939|NCT03129633|"     This study examines the effectiveness of a community health worker (promotores) network in     improving access to care, social support, physical activity and nutrition in Latino     immigrants living in an emerging Latino community.   "
11940|NCT03129620|"     Controlled Hypothermia has become the standard of care for neonates with moderate to severe     HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of     suspected neonatal sepsis, which may or may not be responsible for the etiology of HIE.     Currently, medication dosage regimens are not altered in the setting of CH. A better     understanding of the effects of our interventions on this unique population may help us     tailor our therapy to the specific circumstances of the patient   "
11941|NCT03129607|"     The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and     classification system of postoperative pancreatic fistula (POPF), and received widespread     recognition. Currently, it has become an important reference for clinical treatment of POPF.   "
11942|NCT03129594|"     GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of     GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during     reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release,     vasodilatation and coronary flow in AMI mouse model, one may speculate that total GLP-1 level     may associate with adverse cardiovascular events in AMI patients, the hypothesis is therefore     tested in this study.   "
11943|NCT03129581|"     The investigators are interested in how time-restricted feeding will impact weight, sleep     duration and efficacy, and activity levels in obese adults. Significant advances in digital     mobile technology allow detailed measures of an individual's habits, permitting the     opportunity for personalized dietary and lifestyle recommendations. This is especially     relevant as time-restricted feeding appears to promote weight loss independent of calorie     intake, potentially shifting the paradigm of dietary recommendations from a calorie-based to     a time-based perspective.   "
11944|NCT03129568|"     A phase 1 randomized-controlled study to determine the procedural feasibility and safety and     preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in     patients with dilated cardiomyopathy.   "
11945|NCT03129555|"     No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral     Anticoagulants (NOAC) exists. The DANNOAC-VTE study is a nationwide cluster randomized     cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban,     rivaroxaban and dabigatran for oral anticoagulation in venous thromboembolism across Danish     hospitals.   "
11946|NCT03129542|"     The investigators would like to determine if early administration of oral Midodrine in     participants diagnosed with sepsis will impact blood pressures and decrease the need for     and/or doses of intravenous pressor agents.   "
11947|NCT03129529|"     The main purpose of this study is to compare treatment efficacy of focused and radial     extracorporeal shock waves on spasticity in chronic stroke patient   "
11965|NCT03129295|"     A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with     uncomplicated urinary tract infections.   "
11948|NCT03129516|"     Motor imagery is the mental representation of movement without any body movement. According     to recent studies motor imagery contains three strategies to mentally simulate the movements:     internal visual, external visual and kinesthetic imagery. Motor imagery is associated with     cortical reorganization and functional improvements and it does not only related with motor     performance, it also influces cognitions. Movement Imagery Questionnaire-3 (MIQ-3) is the     recent, modified version of the Movement Imagery Questionnaire-Revised, Second Edition and     measures imagery ability in terms of ease of imagery.      The aim of this study is to translate MIQ-3 into Turkish and evaluate its test-retest     reliability for Turkish-speaking population.   "
11949|NCT03129503|"     The OPTICO-ACS- study program - combining for the first time in vivo characterization of the     ACS-causing culprit lesion by intracoronary imaging technique with optical coherence     tomography (OCT) and molecular analysis of immune-cells derived from the culprit coronary     thrombus and biochemical analyses in patients with acute-coronary-syndrome (ACS).   "
11950|NCT03129490|"     No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral     Anticoagulants (NOAC) exists. The DANNOAC-AF study is a nationwide cluster randomized     cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban,     rivaroxaban and dabigatran for oral anticoagulation in non-valvular atrial fibrillation     across Danish hospitals and cardiology clinics.   "
11951|NCT03129477|"     COPD is the fourth cause of death worldwide and it is expected to be the third in 2020.      Non-invasive ventilation (NIV) has a positive impact in reducing mortality related to chronic     respiratory failure in stable patients with COPD. Moreover, the addition of home NIV to home     oxygen therapy reduces hospital admissions and improves patients outcomes.      Patients monitoring is crucial. It is increasingly recognized the potential of telemedicine     in reducing morbidity and mortality, as well as healthcare utilisation and its associated     costs. In particular, home telemonitoring (TM)- a technology measuring patients`clinical     parameters and symptoms at home and allowing communication between healthcare professionals     and patients over distance- has gained much attention. However, despite a growing body of     evidence for TM in the management of COPD and other chronic diseases, the benefit of     telemonitoring for Home mechanical ventilation concerning clinical and economic outcomes     remains to be clearly demonstrated.      The study aims to assess the impact that telemonitoring would have NIV efficacy, patient     quality of life and satisfaction, through a prospective randomized study.The primary endpoint     is the time for appropriate adaptation and therapy efficacy, defined as average SatO2 to 90%     in 24h oximetry.   "
11952|NCT03129464|"     This is a pilot randomized controlled trial examining post-operative pain scores and outcomes     after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine     post-operative multi-modal analgesia, compared to those patients prescribed routine     multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic     hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If     eligible, patients will be invited to participate in the study and standardized informed     consent process will ensue. After surgery is completed participants will be randomized to     either the control group or the study group. The study group will be prescribed the use of     cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy     is to be applied to participants' incisions for the first three postoperative days, in     addition to routine post-operative analgesia regimen. Investigators will then collect     information on pain scores, narcotic use, quality of life and surgical recovery scores.      This study aims to examine if there is a difference in post-operative pain scores with the     application of cold therapy to laparoscopic abdominal incisions following laparoscopic     hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine     post-operative quality of life scores, postoperative surgical recovery scores, as well as     narcotic use among the two groups. Investigators also aim to ascertain additional information     regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.   "
11953|NCT03129451|"     To investigate the dynamic relationship between the intestinal microbiota and Inflammation in     subjects with Parkinson's disease.   "
12191|NCT03126188|"     The aim of the present study will be to observe the changes in the NTs like Nerve growth     factor, Neurotrophin-3, and Neurotrophin-4 in patients with depression and study the effect     of various antidepressants like Sertraline (SSRI), Dosulepin (TCA), and Venlafaxine (SNRI) on     their levels.   "
11954|NCT03129438|"     Continuous video-EEG monitoring (cEEG) significantly improves seizure or status epilepticus     detection in patients in intensive care units (ICUs), and is recommended for patients with     consciousness impairment. cEEG is time- and resource consuming as compared to routine EEG     (rEEG, lasting 20-30 minutes). While centers in North America have been using it     increasingly, most European hospitals still do not have resources to comply with these     guidelines. In addition, only one population-based study based on discharge diagnoses     suggested that cEEG may improve patients' outcome. Current guidelines are thus based upon     weak evidence and expert opinions.      Aim of the study is to assess if cEEG in adults with consciousness impairment is related to     an improvement of functional outcome, and to address the prognostic role of quantitative     network EEG analyses.      In this multicenter randomized controlled trial, adults with GCS inferior or equal to 11 or     FOUR score inferior or equal to 12 will be randomized 1:1 to cEEG for 30-48 hours or two rEEG     within 48 hours. The primary outcome will be mortality at 6 months. Secondary outcomes will     blindly assess functional outcome, seizure/status epilepticus detection rate, duration of ICU     stay, change in patient management (antiepileptic drug introduced, increased, or stopped,     brain imaging), and reimbursement. Additionally, quantitative EEG will be assessed towards     the primary outcome. 350 patients are planned to be included.   "
11984|NCT03129035|"     All women with placenta accreta will be managed by upper segment cesarean section followed by     cesarean hysterectomy without attempts of placental removal.      Women were randomized to either bilateral internal iliac artery ligation before hysterectomy     and after fetal extraction or no additional intervention   "
12063|NCT03127930|"     This study sought to improve medication management by caregivers of community dwelling     patients with dementia or simple memory loss. This was done by testing a tailored     intervention delivered both in-home and by telephone by either a social worker or nurse. The     intervention was designed to decrease medication deficiencies and improve medication     adherence by developing problem solving skills.   "
11955|NCT03129425|"     The aim of this study is to evaluate the effects of a psychoeducational multidisciplinary     intervention focusing on improving coping skills, the psychosocial adaptation to Parkinson's     disease and the quality of life in patents and family carers in a Primary Care setting.      On the basis of previous research, the hypothesis we propose is that through the development     of coping skills which will contribute to promoting a positive psychosocial adaptation to     Parkinson' disease, the quality of life of the people with Parkinson's disease and their     family carers will be improved. At the same time, it is predicted that, by incorporating this     psychoeducational intervention into clinical practice, the patients and family caregivers     will perceive a greater sense of normality in their lives, which will also promote compliance     with drug treatments and promote healthy lifestyles. In the long-term, such an approach could     have positive effects on the overall health of patients and their family carers.      This quasi-experimental study with control group and mixed methods was designed to evaluate     the ReNACE psychoeducational intervention (ReNACE is the spanish acronym for the Research     Programme and means Recovery, Normalisation, Acceptance and Living with Chronic illness).     Based on the relevant study power calculations, 100 people with Parkinson's disease and 100     family carers will be recruited. Participants will be assigned to two groups. The     intervention group will receive the ReNACE psychoeducational intervention. The control group     will be given a general educational program. The study will be carried out in community-based     health centers. The results obtained from the two groups will be evaluated at three time     points: at baseline, immediately after the intervention and at 6 months after the     intervention. The results will be measured with the following instruments: the Quality of     Life Scale PDQ-39 (The 39-item Parkinson's Disease Questionnaire) for patients and the     Quality of Life Scale for caregivers SQLC (Scale of Quality of Life of Caregivers) for family     carers, and for patients and family carers the Psychosocial Adjustment to Illness Scale     Self-report (PAIS-SR) and the Brief Cope Inventory. To determine the acceptability of the     intervention, focus groups will be organized with some patients and family carers who have     received the ReNACE intervention and also with the healthcare professionals involved in its     development.   "
11956|NCT03129412|"     Oligo-metastases NPC patients received radiation for primary tumors and treatments for     metastatic lesions.   "
11957|NCT03129399|"     This study was designed to determine the comparison between the King Vision video     laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were     divided into 2 groups of 40 patients each.Patients of King Vision group [n=40]and Macintosh     group [n=40]were intubated using respective devices.This study is the first to search the use     of King Vision video laryngoscope for nasotracheal intubation in difficult airway.   "
11958|NCT03129386|"     This study is investigating the normal range of maximal diaphragm thickness during a sniff     inspiratory manoeuvre using ultrasound in healthy subjects stratified by age and gender.   "
11959|NCT03129373|"     The present study was set-up to evaluate clinical efficacy of Pixie® cryogenic pen versus two     comparator cryogenic products (Wartner® and Wortie®) for the treatment of common and plantar     warts.   "
11960|NCT03129360|"     In order to establish target engagement and identify an effective dose the investigators will     conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500     mg in 24 medication-naïve early psychosis (EP) patients, measuring hippocampal activity by     pulsed arterial spin labelling (ASL) pre-dose and 2 hours post-dose. The lower dose is     calculated to achieve blood levels within the range that were associated with reduced     hippocampal activity and improved cognition in patients with mild cognitive impairment; the     higher dose is a typical antiepileptic dose. Successful demonstration of target engagement     will be defined by an effect size of 0.5 or greater compared to placebo in reduction by     levetiracetam of hippocampal blood flow measured by ASL. The optimal dose will be defined by     maximal reduction of hippocampal perfusion in the absence of clinically-significant adverse     effects. The investigators will also study 8 healthy control subjects to verify that baseline     hippocampal blood flow is elevated in the sample of FEP subjects.   "
11961|NCT03129347|"     This study will be to compare the pharmacokinetics of nalmefene administration intranasal     with and without an absorption enhancer compared to an intramuscular injection.   "
11962|NCT03129334|"     This Fast-Track SBIR project is designed to address the urgent need for an effective primary     prevention approach to the problem of prescription drug misuse and abuse (PDA) among middle     school students. The project involves developing, feasibility and effectiveness testing of an     innovative new approach to the primary prevention of PDA among middle school students     utilizing both online e-learning and small group facilitator-led intervention modalities. The     intervention is an adaptation of the successful evidence-based substance abuse and violence     prevention approach called Life Skills Training (LST). The adapted intervention will address     the relationship between PDA and alcohol, tobacco and other drug (ATOD) use and abuse;     positively change social norms surrounding ATOD and PDA; discourage diversion of prescription     medications; enhance protective factors by building social and self-regulation skills through     interactive learning and behavioral rehearsal scenarios.   "
11963|NCT03129321|"     To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1%     to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis.      To demonstrate the superiority of the Test and Reference (active) treatments over Placebo     treatment in patients with tinea pedis.      To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.   "
11977|NCT03129126|"     The purpose of this study is to assess the safety and tolerability of three doses of LP-10     (intravesical tacrolimus) compared to placebo. Eighteen subjects meeting the inclusion and     exclusion criteria will be enrolled and treated in a prospective, doubleblind, randomized,     placebo controlled, and multicenter trial with LP-10. The proposed trial will recruit 18     subjects in a dose-escalation trial where 6 subjects will be allocated into each one of three     groups.   "
11964|NCT03129308|"     The spectrum of reported autoimmune phenomena in HIV infected patients is unexpectedly broad     and - owing to the current efficacious treatment regimes - increasing. The likelihood of the     occurrence of autoimmune phenomena correlates with a high CD4 count, consequently they are     found most frequently soon after infection or after immune reconstitution. It is likely that     recent developments, namely the recommendation to treat all patients regardless of their CD4     count, may lead to a further increase in autoimmune phenomena in HIV infected patients. In     contrast to the abundance of data of rheumatological and hematological autoimmune disease in     HIV infected patients, no systematic study exists which has analyzed the prevalence of     autoimmune blistering disease and/or associated autoantibodies in these patients.      The investigators therefore intend to determine the prevalence of selected autoantibodies in     our HIV cohort in relation to uninfected controls. According to recent guidelines, all HIV     infected patients should receive anti-retroviral treatment at the earliest time point     possible, making the restoration of the immune system more likely and leading to a further     alignment of the life expectancy relative to age matched, uninfected controls. As a     consequence, the incidence of AIBD, especially of bullous pemphigoid, for which age is the     single most important risk factor, may rise.      In total, knowledge about the prevalence of AIBD specific auto antibodies might be supportive     in the diagnosis of these conditions in the future.   "
11966|NCT03129282|"     Depression and anxiety are highly prevalent in people with heart disease, causing immense     human and economic burden. Available pharmacological and psychological interventions have     limited efficacy and the needs of these patients are not being met in cardiac rehabilitation     services despite emphasis in key NHS policy.      Extensive evidence shows that a particular style of thinking dominated by rumination     (dwelling on the past) and worry maintains emotional distress. A psychological intervention     called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression     and anxiety in mental health settings.      This is a single-blind feasibility randomised controlled trial of metacognitive therapy     delivered in a home-based format (Home-MCT). The aim of the study is to evaluate the     acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services     and to provide provisional evidence of effectiveness and cost-effectiveness on Home-MCT.   "
11967|NCT03129269|"     The current study seeks to examine the prevalence of amyloid pathology, among patients     referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We     also aim to fully characterize the clinical progression of frail cognitively impaired     patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive     impairment but do not have AD pathology.   "
11968|NCT03129256|"     This study is to explore the potential efficacy and safety of low-dose Apatinib combined with     S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with     oral apatinib and S-1 after treatment failure of standard regimen.   "
11969|NCT03129243|"     In the current era of assisted reproductive techniques where technology can help overcome     defects in sperm function, the value of semen analysis has become even more inaccurate.     Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the     natural selection process and enable men with severely impaired semen parameters to achieve     both clinical pregnancy and live birth   "
11970|NCT03129230|"     This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft     in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in     pediatric patients, by presenting the clinic-radiological outcome and complications.   "
11971|NCT03129217|"     This study is designed to determine whether maximal diaphragm thickening fraction measured by     ultrasound during volitional maximal inspiratory efforts is a valid measure of diaphragm     function in mechanically ventilated patients.   "
11972|NCT03129204|"     The purpose of the feasibility study is prevention of Post Intensive Care Syndrome in Family     (PICS-F), specifically in spouses of critically ill, mechanically ventilated patients, using     a nonpharmacological intervention called Sensation Awareness Focused Training (SĀF-T). This     will be accomplished using a prospective, randomized, experimental design to achieve robust     and unbiased results.   "
11973|NCT03129191|"     Recently, a new non-invasive bone conduction hearing aid was introduced. The system is     connected directly to the skin with an adhesive adapter to transmit the sound to the inner     ear through bone vibrations. The objective of this study is to evaluate and compare the     audiological benefit of the new bone conduction hearing aid and compare it to an existing     bone conduction hearing aid in normal hearing adults with bilateral simulated conductive     hearing loss.      An evaluation of the improvement on speech understanding in noise and sound localization     allows to estimate the system performance and enables to derive recommendations for clinical     usage of the novel hearing system. It is hypothesized that in the bilateral condition similar     speech understanding in noise and sound localization performance can be achieved with the new     system compared to existing bone conduction hearing aids that are pressed against the skull     using a soft band.   "
11974|NCT03129178|"     Individuals with Raynaud's phenomenon often experience episodes of reduced blood flow to     their fingers and toes during times of stress or cold exposure, causing significant     discomfort and pain. Typically, treatment for these individuals involves using drugs like     Glyceryl Trinitrate (GTN), which increases blood flow to the fingers and toes by increasing a     substance called nitric oxide in the blood. Unfortunately, repeated use of these drugs     increases tolerance to them, meaning higher doses are required to produce the same effect.     However, increasing the dose can cause more side effects like headaches, and is therefore not     considered an ideal long-term therapy.      Leafy green vegetables, especially beetroot, contain high amounts of nitrate and are     beneficial to blood vessel health, since nitrate from the diet can also be turned into the     important blood vessel relaxer, nitric oxide. Unlike GTN, people don't appear to develop a     tolerance to dietary nitrate or experience negative side effects.      Therefore, this study aims to see if short and longer term beetroot juice supplementation can     improve blood flow to the hands and feet in individuals with Raynaud's phenomenon, as well as     reduce their pain. This study will tell us how many people are needed for a definitive trial     investigating whether beetroot juice can help treat Raynaud's phenomenon.      Raynaud's phenomenon can cause significant discomfort and pain to individuals. Dietary     nitrate appears to offer a simple, low cost means of improving blood flow to the hands and     feet which should reduce both the discomfort and pain experienced characterising this     condition. This study will advance our understanding of the causes of Raynaud's phenomenon,     specifically the role that the nitrate-nitrite-nitric oxide pathway might play in changing     Raynaud's phenomenon symptoms and identifying targets for intervention.   "
11975|NCT03129165|"     The purpose of this study is to determine the efficacy and cost/effectiveness (change in CV     risk factors and lifestyle vs costs) of ProSALUTE as a new organizational model of primary CV     prevention.   "
11982|NCT03129061|"     This is a single-center cross-sectional imaging and correlative biomarker study in patients     with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with     unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment     and Cohort 2 will be neoadjuvant study participants who will receive one dose of anti-PD-1     treatment prior to tumor resection or radiation. Blood sampling and tissue biopsies will be     collected from both cohorts and both cohorts will undergo two whole body PET(Positron     Emission Tomography)/CT(Computed Tomography) imaging with [18F]F-AraG. First scan prior to     initiating anti-PD-1 treatment and second scan post initiation of anti-PD-1 treatment in     Cohort 1 and prior to tumor resection or radiation in Cohort 2   "
11983|NCT03129048|"     The deleterious effects of obesity on cardiovascular disease (CVD) and metabolic risk factors     (dyslipidemia, hypertension, and insulin resistance) are well-documented. Recent evidence     also links obesity to cognitive decline and dementia. Dietary patterns are central to the     development and maintenance of obesity and certain dietary patterns may contribute to the     onset and progression of cognitive decline. With the rapid aging of the US population and the     high prevalence of obesity among older adults, innovative lifestyle strategies to prevent     cognitive decline among ethnically diverse obese older adults are critically needed.   "
12064|NCT03127917|"     The objective of this project is to determine the importance of peripheral vascular function     on gait performance in older adults.   "
11985|NCT03129022|"     Women requesting epidural analgesia will receive a bolus of intravenous infusion of lactated     Ringer's solution before initiation of the procedure. An 18-gauge Tuohy needle and closed-tip     clear catheter with three lateral orifices (Portex, Smith Medical, Hythe, UK) were used in     the sitting or lateral position, with a loss-of-resistance to air technique. Epidural     catheters will be inserted 5-6 cm inside the epidural space. A test dose of 2 ml of lidocaine     2% iss initiated followed by a loading dose of 10 ml of bupivacaine 0.25%. Analgesia is     established and maintained throughout labor and delivery using 0.125% bupivacaine with     fentanyl 2 μg/ml with patient-controlled epidural analgesia by means of a continuous epidural     infusion (8 ml/h basal rate) and patient-controlled boluses (3 ml each) with 20-minlock-out     intervals, continued at the same bolus dose until delivery.      Pain was evaluated using a 0-10 cm visual analogue scale (VAS) before, 15 and 30 min after     the loading dose followed by hourly assessment until delivery. VAS score assessment was based     specifically on abdominal or back pain resulting from contractions   "
11986|NCT03129009|"     Spontaneous non-traumatic intracerebral hemorrhage (ICH) is a common symptom in clinical     practice and is the most serious among all types of stroke.Recently, as a relatively     mainstream and recognized INTERACT2 (five well-known international studies in the     cerebrovascular field: IMS-III, MR RESCUE, SYNTHESIS EXPANSION, INTERACT2, CHANCE) studies     have shown that in patients with standard systolic blood pressure Early intensive     antihypertensive therapy does not increase the incidence of death or serious adverse events.     The above studies confirm the safety and efficacy of early potent depression.In 2017,     Anesthesiology published a META analysis of intraoperative hypotension and blood pressure     versus baseline fluctuations. The final outcome showed that 20% of blood pressure in the     study was similar to MAP <65 mmHg, regardless of the duration of the duration There will be     postoperative myocardial and renal damage. Ischemia is a very important cause of organ     damage. Myocardial injury is closely related to the level of mean arterial pressure, while     ischemia and ischemic reperfusion injury are closely related to postoperative acute renal     injury.There is no targeted guideline for ICH perioperative blood pressure management,     especially intraoperative blood pressure management, and no previous studies have studied     most of the studies involving ICH patients with conservative treatment, ICH patients with     surgical treatment There are few reports on blood pressure control during surgery.   "
11987|NCT03128996|"     This study is designed to estimate the efficacy and toxicity of familial HLA mismatched bone     marrow transplants in patients with non-malignant disease who are less than 21 years of age     and could benefit from the procedure.   "
11988|NCT03128983|"     Research results suggest changes of physiological parameters such as heart rate, respiration,     skin conductance response, sleep duration, sleep quality and skin perfusion during the     menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record     these parameters. The present study aims to evaluate whether there is a correlation between     physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine     ovulation test and the onset of menses. To collect data women will wear two smartwatches and     a smartshirt at night. All three devices are CE-approved for sports and fitness.   "
11989|NCT03128970|"     The aim of the present study is to determine if implantation rate could be increased in women     undergoing frozen embryo transfer cycles in case of adjusting their embryo development at     hatching or hatched stage.   "
11990|NCT03128957|"     Controversy surrounds the use of regional cerebral oximetry (rSO2) as a measure of true     cerebral oxygenation because of extracranial signal contamination and unmeasured confounding     of cerebral a:v ratio. The measurement of brain tissue oxygen (PbrO2) has been used in     routine neurosurgery and has been shown to reliably demonstrate cerebral hypoxia following     severe head injury. It is the most direct measure of cerebral oxygenation. Here, we test the     hypothesis that there is a correlation between PbrO2 and rSO2 under conditions of varying     inspired oxygen fraction and the varying partial pressure of carbon dioxide in arterial blood     in uninjured, normal human brain.      Patients who are scheduled for elective removal of secondary cerebral metastases under     general anesthesia will be recruited following written informed consent obtained by a study     team member during their preoperative evaluation. BIS and rSO2 optodes will be applied,     before induction of anesthesia, by a single researcher on both sides of the patient's     forehead, as recommended by the manufacturer. General anesthesia will be maintained by total     intravenous anesthesia (TIVA) with a combination of propofol (80-150 mcg/kg/min) and     remifentanil (0.05-0.1 mcg/kg/min) targeted to a Bispectral Index range 40-60 (BIS; Covidien,     Boulder, CO). Following craniotomy, the LICOX probe will be placed under direct vision into     an area of normal brain within the tumor excision canal by the attending neurosurgeon. During     a pause in surgery FIO2 and minute ventilation will be sequentially adjusted to achieve the     following pairs of ventilation set points: 1) FIO2 0.3 and paCO2 30mmHg, 2) FIO2 1.0 and     paCO2 40mmHg. After ≥5 minutes at each set point FIO2, PaCO2, rSO2 and PbrO2 will be recorded     as a snap-shot.      A sample size of 15 achieves an 80% power with a one-sided type I error of 5% to detect a     positive correlation of 0.6 (from the null hypothesis of no correlation) between changes in     PbrO2 and changes in rSO2 subsequent on alterations made in ventilation strategy. Correlation     will be measured using Pearson's Correlation. P values < 0.05 will be considered     statistically significant.   "
31819|NCT02869256|"     It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous     leukemia cases of registration (CML) prospectively and retrospectively.   "
11991|NCT03128944|"     The investigators are developing Blood Pressure Imager (BPI), which is a new technology that     does not require cuffs or expensive equipment, and can be used by untrained individuals in     underserved, low-resource environments at their own homes or regional care settings. Over the     last one-year the investigators have developed the BPI prototype, which is ready for testing.     BPI is a wrist device that includes a camera, LED lights and soft membrane with a reflective     coating. In this device feasibility study, the BPI will be placed over the radial artery at     the wrist with the help of a wrist strap. The primary purpose of this feasibility study is to     compare the BPI with a commercially available cuff-based blood pressure measuring devices.   "
12010|NCT03128671|"     This randomized clinical trial tests a cognitive reorientation intervention to prevent     delirium in the intensive care unit using scripted audio messages, recorded by the patient's     family and played at hourly intervals during daytime hours, to provide information about the     ICU environment to the patient (the Family Automated Voice Reorientation intervention,     FAVoR). The investigators hypothesize that providing ongoing orientation to the ICU     environment through recorded audio messages in a voice familiar to the patient will enable     the patient to more accurately interpret the environment and reduce risk of delirium.     Increasing awareness of daytime by cuing patients during waking hours may also improve     day/night orientation, nighttime sleep/rest, and further reduce risk of delirium.   "
12085|NCT03127644|"     To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese     patients with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).   "
11992|NCT03128918|"     The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple     blood test, to diagnose NASH in patients who undergo liver transplantation. Liver     transplantation is a life-saving procedure for people with cirrhosis. Fatty liver is a common     reason for liver transplantation due to obesity and diabetes. Fatty liver can happen again to     the new transplanted liver and it is often due to metabolic risk factors (including diabetes,     rapid weight gain, and immunosuppressive therapy, which are used to avoid rejection of the     new liver). Some patients with fatty liver after liver transplant have non-alcoholic     steatohepatitis (NASH) injury to liver the tissue (inflammation) and damage which is caused     by a build-up of fat in the liver. This is a serious problem and can lead to cirrhosis and     loss of the transplanted liver. There has been no detailed study into the recurrence of NASH.     One reason for this is one of the only ways to detect fatty liver and NASH is to have a liver     biopsy, which can be painful and have complications. Recently, a new technology (Fibroscan)     and a simple blood test (cytokeratin 18) have been developed which can tell doctors how much     a liver is damaged and how much fat it contains without pain or complications. This is a year     long study involving one screening visit and 3 study visits, 3 months apart.   "
11993|NCT03128905|"     Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a     very frequent affection of the elderly and causes very painful arthritis.      International recommendations for the treatment of patients suffering from CPPD are based     upon rare studies, not randomized, with small samples, and thus very weak scientific     evidence.      The treatment of CPPD arthritis is extrapolated from the experience of gout treatment,     another crystal deposition disease.      Among recommended treatments, colchicine and oral steroids are recommended as first-line     treatments, while NSAIDs are used with caution in elderly populations of patients.      Colchicine utilization is not risk-free, in particular with old patients and patients with     renal impairment.      Drug interactions of colchicine can have serious consequences, especially in a polymedicated     old patient's population.      Oral steroids are an interesting alternative in this indication with a potential of being     better tolerated, but comparative efficacy with colchicine needs to be studied.      From a broader point of view, colchicine and oral steroids have never been compared in any     crystal related arthritis.      This is the first large randomized controlled trial for CPPD acute arthritis.   "
11994|NCT03128879|"     The goal of this clinical research study is to learn if giving the drug venetoclax with     ibrutinib can help to control the disease in patients with chronic lymphocytic leukemia (CLL)     or small lymphocytic lymphoma (SLL). The safety of this combination treatment will also be     studied.   "
11995|NCT03128866|"     The goal of this clinical research study is to determine if tranexamic acid can help in     reduction of blood and blood product loss before, during, and after surgery.   "
11996|NCT03128489|"     The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when     administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian     regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of     care.   "
11997|NCT03128476|"     In Southeast Asia, Essence of Chicken, a chicken-meat-extract, is a popular beverage and is     consumed as a traditional remedy for several ailments, including the use as a nutritional     supplement for sickness, enhancement of mental efficiency, and recovery from mental fatigue.     While the elderly use it as a nutritional supplement, students use it for relief from anxiety     during exam times.      The present study is conducted in order to assess the effects of BEC on various physical and     mental parameters including physical fatigue, working memory and attention, mood and stress,     in comparison to placebo.   "
11998|NCT03128463|"     Macular neovascular diseases including age-related macular degeneration (AMD), polypoidal     choroidal vasculopathy (PCV), pathological myopia (PM) and etc. can cause severe vision loss.     It has become the focus of World Health Organization's blindness- prevention cause. A new     anti—VEGF drug conbercept has been approved and showed good efficacy and safety in clinical     trials. But the exact therapeutic regimen and the efficacy in the real world still needs to     be further studied, the reasons are as follows:        1. The efficacy and safety data of conbercept are collected from rigorous random controlled          trials (RCT) , it can not fully reflect the clinical application of conbercept in the          real world . Therefore, the knowledge of the therapeutic regimen, safety and efficacy of          conbercept is still limited.        2. Conbercept has been approved for wet-AMD only, but in clinical practice, some doctors          applied other off-label use of conbercept. These off-label use has become a common          phenomenon all over the world for the instruction book of drugs usually lag behind          scientific researches. There is no specific law or regulatory document of drug off-label          use in China until now.        3. Anti-VEGF drugs are expensive and often require multiple treatments, and some patients          have poor or even no response to the drugs. This resulted enormous waste of medical          resources. So, how to accurately find out those patients who have good response, how to          develop individualized therapeutic regimen, and the response of patients in the real          world need to be urgently investigated in the aspect of pharmacogenomics, and          pharmacometabolomics.      Therefore, the investigators plan to carry out real-world researches of conbercept on     treating macular neovascular diseases has significance and urgency.      The investigators intended to conduct a nationwide, non-intrusive, prospective,     observational, and multicenter registration study to investigate the efficacy of conbercept     in the real-world. And this study will explore the pharmacogenomics and pharmacometabolomics     of conbercept, relationships of phenotype and the effectiveness of the drug, optimize the     therapeutic regimen, then reduce the financial burden of patients and save the limited     medical resources to achieve the purpose of accurate treatment.      For three unanswered questions raised in the background, the researchers carried out the     following purposes:        1. Investigate the safety and efficacy of conbercept in treating neovascular macular          disease in the real world.        2. Find out whether the off-label use of conbercept on PCV and PM have good efficacy.        3. Explore the pharmacogenomics and pharmacometabolomics of conbercept through large-sample          registration study.   "
12008|NCT03128697|"     The global research project was organized as a clinical process starting with an evaluation     aiming at the determination of a diagnosis pertaining to the degree of satiety signal     capacity. It was extended by a phase of metabolic and behavioural characterization to better     understand the clinical condition of the patients. The main part of the program was a weight     loss intervention that was focused on high satiating foods. Finally, the process was     completed by an evaluation allowing to determine the impact of the intervention on the     metabolic and behavioural conditions of the patients.   "
31933|NCT02867774|"     The purpose of this pilot study is to evaluate the impact of an intervention to increase     physical activity on pain, function and quality of life in women with chronic pelvic pain.   "
12024|NCT03128437|"     This is a randomized control trial to test the effect of an anxiety sensitivity intervention     on health behaviors among 18-35 year-olds.   "
12025|NCT03128424|"     The primary objective of the feasibility study is to evaluate the safety and effectiveness of     the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native     superficial femoral artery (SFA) or the superficial femoral and proximal popliteal arteries.   "
12026|NCT03128411|"     Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of     the study.   "
11999|NCT03128814|"     Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven     loading, this gradually results in structural (e.g. increased bone and muscle mass) and     functional (e.g. increased strength) adaptations to the dominant side of the body. The     corresponding structural and functional asymmetry can be further accentuated by (intensively)     practicing a unilateral sport such as tennis, which is very popular. Yet, research on this     particular topic is scarce, especially in (pre)adolescent players. Existing studies, which     often face methodological shortcomings (e.g. crosssectional designs, small sample sizes, no     link to field methods), mainly focus on adults and structural asymmetry of the upper     extremity itself, with very little or no attention to whole body structural as well as     functional asymmetry. Moreover, the link of both forms of asymmetry with growth and     maturation, everyday locomotion, technical skill performance and whole body injury is     currently not (fully) understood. Therefore, the main purpose of this research project is to     gain comprehensive knowledge on the degree, development and implications of both structural     and functional asymmetry during a critical period in life using a longitudinal approach. As     such, this project among youth elite tennis players will provide insights on the extent to     which structural and/or functional asymmetry is acceptable for being most successful but     remaining injury free.   "
12000|NCT03128801|"     Background: Low back pain is a major problem for public health that affects about 60-85% of     the population at some point in life. Approximately 10-40% of individuals with low back pain     develop the chronic form. International guidelines consider three groups of treatment options     for low back pain: medication, invasive and conservative treatments in which conservative     approach is the most recommended. The European Guidelines for Management of Chronic     Non-specific Low Back Pain recommends that supervised exercise programs should be used as     front-line treatment for chronic low back pain, such as stabilization exercises, conventional     stretching and other active exercise, but there is no consensus on literature on the most     effective form of treatment. However, there is limited evidence about the effects of a global     stretching intervention using self-stretching postures for chronic low back pain.      Objectives: The aim of this research is to compare the effects of an active global stretching     program (GSP) using self-management of posture versus stabilization exercises versus a mixed     program (GSP and stabilization exercises) on pain intensity and disability for patients with     chronic non-specific low back pain.      Methods: This study is a randomized controlled three arm clinical trial with examiner     blinding. A sample of 129 patients with chronic non-specific low back pain will be randomly     assigned to three treatment groups (GSP, Stabilization Exercises and Mixed group). The     eligibility criteria will be 18 and 50 years, pain in the last three months and/or pain in at     least half of the days in the past six months, pain located between T12 and the gluteal     folds, pain intensity greater than or equal to three, and score greater than 14% on Oswestry     Disability Index. Patients will be assessed in baseline, immediately after treatment and     after one and three-months follow-up. Sessions will be provided weekly for eight weeks by a     single therapist lasting 40 minutes. The primary outcomes will be pain intensity and low back     pain related disability and the secondary outcomes will be fear avoidance, global perceived     effect of treatment and muscle flexibility. All statistical analysis will be conducted     following principles of intention to treat, and the treatment effects will be calculated     using linear mixed models.   "
12001|NCT03128788|"     It is reported that the distribution of contrast medium had an obvious correlation with the     extent of sensory analgesia after injection of LA. Our previous study showed that different     posture (prone vs. lateral decubitus) resulted in different degree of contrast medium spread.     We supposed that differences of epidural pressure between diverse postures might be one     factor contributing those differences of epidurography.      This study was designed to compare the epidural pressure and extent of spread of     epidurography between prone and lateral decubitus position   "
12002|NCT03128775|"     The objective of the present study is to estimate the effect of nudging proposals on the     students' Body Mass Index, based on changes made in the school environment. This is a     factorial randomized community trial, which will be conducted in 18 public schools in the     city of Duque de Caxias, RJ.   "
12003|NCT03128762|"     The primary objective of this study is to demonstrate differences in ILC2 blood levels     between asthma patients and control patients.   "
12004|NCT03128749|"     Obsessive-Compulsive Disorder (OCD) patients have a response rate of 50-60% to exposure and     response prevention (ERP) therapy and SSRI antidepressants. Mindfulness-Based Cognitive     Therapy (MBCT) consists of training the participant to non-react to negative thoughts and     emotions. Applying MBCT to OCD patients may help them behave with equanimity in response to     their obsessions, and therefore acknowledge them with the same attention and intention as     they admit any other disturbing thought without reacting to it. MBCT has demonstrated     effectiveness in major depression, but much less attention has been given to MBCT in OCD. ERP     and MBCT, although sharing aspects like exposure, are based on different theoretic and     therapeutic factors. EPR is based on a direct anxiety habituation process whereas MBCT trains     a holistic manner of becoming familiarized with distressful thoughts and emotions while     learning to develop a new relationship to them. Thus, MBCT may decrease anxiety indirectly     through a major attention awareness and non-reactivity to thoughts and emotions.      OCD is characterized by altered cortical-striatal-thalamic-cortical (CSTC) circuit and     default mode network (DMN) connectivity when performing different tasks and during the     resting state. It has been establish that the ventral CSTC circuit is mostly associated with     emotional processing, while the dorsolateral aspect of the CSTC circuit is preferentially     involved in cognitive processing. In this regard, we hypothesized that clinical amelioration     will be accompanied by a re-establishment of functional connectivity within dorsolateral and     DMN circuits, which will in turn be associated with improvement of certain neuropsychological     processes. CSTC and DMN circuits have also shown to be sensitive to prolonged stress     situations. Specifically, childhood trauma has been related to larger brain volumes and it     has been associated with different OCD clinical subtypes.      Aims: 1. To assess MBCT effectiveness in treatment non-naive OCD patients. 2. To study     cognitive and neuropsychological characteristics that mediate or moderate MBCT response. 3.     To examine the changes in cognitive, neuropsychological and neuroimaging patterns associated     with an MBCT intervention. 4. To identify a brain biomarker for positive response to MBCT in     non-naïve OCD patients. 5. To study cognitive, neuropsychological and early stress expousure     mediators or moderators of functional changes in CSTC and DMN patterns in response to MBCT.   "
12005|NCT03128736|"     Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating     gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical     effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg.     This pilot study aims to compare the one-week clinical effects of single doses of the two     drugs in treating GERD patients.   "
12006|NCT03128723|"     The study will look to evaluate the tolerance of a light therapy-based acne mask device in     participants who report having sensitive skin. All participants will receive a cleanser, a     light therapy mask, and an extra activator for the light therapy mask.   "
12007|NCT03128710|"     There have been calls from patients, payers, healthcare providers, and policy makers for an     evaluation of newer, high-cost radiation technologies compared to conventional forms of     radiation therapy. National attention has focused on the use of intensity modulated radiation     therapy (IMRT) into routine daily clinical practice for prostate cancer. The goal of the     present study is to determine whether the type of radiation treatment received by the     patients can result in a reduction in patient-relevant side effects following prostate     irradiation. The analysis will be performed by obtaining patient answered surveys looking at     side effects.   "
12009|NCT03128684|"     The Lentil Satiety study will examine the effects of replacing wheat, rice, and potato with     two types of lentils within food products (muffins, chilies, and soups) on satiety and food     intake in healthy adults.   "
12011|NCT03128658|"     While a number of factors are known to be associated with the development of trauma induced     coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which     patients are at risk for developing these life threatening conditions with any certainty. In     this prospective observational study, we will investigate the many factors that contribute to     the development of trauma induced coagulopathy, post injury inflammation and the development     of organ dysfunction in order to develop a multi scale computational algorithm of clinical     prediction. Using a convenience sample technique, demographic data, physiologic data, blood     samples and clinical variables will be collected over 5 days following traumatic injury. A     computational model will be used to predict the development of TIC and multi-organ failure.   "
12012|NCT03128645|"     In patients with central obesity, the effect of the abdominal corset on colonoscopy     completeness, cecum and ileum intubation time will be investigated.   "
12013|NCT03128619|"     This phase I/II trial studies side effects and best dose of copanlisib when given together     with letrozole and palbociclib and to see how well they work in treating hormone receptor     positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as     letrozole, may lessen the amount of estrogen made by the body. Giving copanlisib, letrozole,     and palbociclib may work better in treating patients with breast cancer.   "
12014|NCT03128606|"     The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single     center study, evaluating single and multiple ascending oral doses of GLPG3067 and the     combination of GLPG3067 and GLPG2222 given for 14 days in healthy women of non-childbearing     potential.      The purpose of the study is to evaluate the safety and tolerability of single ascending oral     doses and multiple ascending oral doses of GLPG3067 given to healthy women of     non-childbearing potential compared to placebo, as well as of multiple oral doses of the     combination of GLPG3067/GLPG2222 compared to GLPG3067/placebo.   "
12015|NCT03128593|"     The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below,        -  to collect the safety information of JR-141        -  to evaluate the plasma pharmacokinetics of JR-141        -  to explore the efficacy of JR-141 on MPS II-related central nervous system symptoms and          general symptoms   "
12016|NCT03128580|"     The purpose of this study is to compare the number of euploid embryos obtained per metaphase     II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles.   "
12017|NCT03128567|"     Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to     improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years,     an increased rate of side effects such as post-operative cognitive decline and/or postural     instability with falls has been suspected with less improvement in the quality of life. Here,     Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged     more 69 years in a randomized parallel controlled study.   "
12018|NCT03128554|"     Traditional models of smoking cessation focus on delivering advice and counseling to quit and     providing assistance to patients ready to quit smoking, but do not actively intervene with     patients who are not ready to quit (NRTQ). This abrupt cessation approach is often not an     appealing option to those not ready to quit, however, a reduction approach can seem more     attainable and engaging. In response to this need, this smoking cessation intervention has     been developed.      This research is part of a pilot study to assess the feasibility of introducing a NRTQ     intervention in a primary care setting. This study will also assess the effectiveness of     increasing the number of smoking reduction interventions delivered, provider confidence and     satisfaction, relative to control practice. Outcomes will be assessed by a pre-survey and a     three-month follow-up survey, administered to all study participants. All study participants     will also be asked to fill out brief NRTQ consult forms for each NRTQ patient they encounter     for a two-week period. Additionally, participants randomized to the intervention arm will     receive training, and access to tools and resources.   "
12019|NCT03128541|"     The study aims to ascertain whether being placed in a sitting or lateral decubitus position,     influences identification of the midpoint of the L4/L5 intervertebral space, using manual     demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral     decubitus position. The mid-point of the L4/L5 intervertebral space will be identified using     anatomical palpation and compared to the true mid-point measured by ultrasound. The     procedure will be repeated in both positions on the same participant.The study will be a     prospective, randomized, double blinded, crossover trial   "
12020|NCT03128528|"     The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in     patients with chronic heart failure, and if the hypothesis is proven, that this mechanism     contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via     exerting beneficial effects on the vascular structure and function of the micro- and     macrocirculation.   "
12021|NCT03128515|"     The Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM) study is the first     placebo-controlled randomized clinical trial of hydroxyurea treatment in a malaria endemic     region. NOHARM has now achieved full enrollment; all children have completed the blinded     portion of the protocol and are in the open-label study treatment portion.      This extension study of maximum tolerated dose (MTD), addresses the next critical set of     questions about the optimal dosing and monitoring of hydroxyurea treatment for children with     SCA in low-resource settings. By providing guidance about optimal hydroxyurea treatment, the     NOHARM MTD Study will directly inform policies that can transform the health of African     children living with SCA.   "
12022|NCT03128502|"     Subjects were selected from the outpatient clinic, Department of Oral Medicine and     Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control     subjects presented with clinically healthy periodontium. Ten patients who had plaque induced     gingivitis. Ten patients who had generalized chronic periodontitis. Ten patients who had     generalised aggressive periodontitis. Pentraxin-3 levels were evaluated in GCF and saliva of     all subjects included in this study with ELISA technique.   "
12023|NCT03128450|"     This Pilot study will evaluate the safety and Efficacy of an investigational cell     transplantation therapy, h-NSC, in patients with Parkinson's disease, through nasal drug     delivery, a new delivery way. All patients will receive the therapy, which consists of human     neural stem cells,   "
12027|NCT03128398|"     This is an Expanded Access to Investigational Drug program available through the FDA. Some     specific conditions to qualify for this program includes gastroesophageal reflux disease with     upper GI symptoms, gastroparesis, and chronic constipation. Patients failing standard     therapies for these conditions may be eligible to receive domperidone. This program     facilitates availability of investigational drugs, (such as domperidone) to patients with     serious diseases or conditions when there is no comparable or satisfactory alternative     therapy to diagnose, monitor or treat the patients's disease or condition. Authorization must     be obtained from FDA prior to the importation, interstate shipment and administration of     domperidone.   "
12028|NCT03128385|"     This 3-year research project aims to investigate and compare the treatment effectiveness (in     terms of motor and psychosocial outcomes) and potential predictors (in terms of     demographical, biological and psychosocial domains) of the intensive and distributed Child-     and Family-Friendly CIT protocols with an equivalent intervention period in children with CP     by cross-over study design. In addition, the selection and examination of outcome measures     were based on the ICF-CY model to provide comprehensively documents.   "
12029|NCT03128372|"     The primary objective of the study is to validate that the production equivalent PM7100     System in conjunction with Adult Sensors (PMSENS71-A) meet product requirements for cerebral     accuracy, cerebral trending accuracy, and somatic trending.   "
12030|NCT03128359|"     This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and     mycophenolate mofetil work in preventing graft versus host disease in patients with     hematological malignancies undergoing myeloablative or reduced intensity donor stem cell     transplant. Sometimes the transplanted cells from a donor can make an immune response against     the body's normal cells (called graft versus host disease). Giving high dose     cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this     from happening.   "
12032|NCT03128333|"     The aim of this study is to examine whether self-monitoring PA with the RunKeeper app with     additional physiotherapy coaching is superior in improving patients' self-reported     leisure-time PA compared with usual care in cancer patients after 12 weeks.      This is a single-center, prospective, two-armed, randomized controlled trial. Adult cancer     patients and cancer survivors are randomized in one of the two study arms, (Group A)     RunKeeper app + physiotherapy coaching or (Group B) usual care.      Patients assigned to the intervention group will be instructed to use the RunKeeper app for     12 weeks to self-monitor leisure-time PA. In addition, patients will be educated about the     health risks of a sedentary lifestyle, inactivity and (when applicable) other unhealthy     lifestyle behaviors (e.g. unhealthy diet, overweight or obesity, sun exposure, alcohol     intake). Benefits of a behavior change, becoming physically active and pursuing a healthy     lifestyle will be explained by a trained physiotherapist who will also coach the patient     during the PA program. The biweekly physiotherapy coaching starts at baseline and will follow     a structured sequence of strategies to change patients PA behavior which will contribute to     the adoption of leisure-time PA in patients daily living, so the program will be optimally     tailored to the patients capabilities and preferences.      The primary endpoint is to examine the effectiveness of the RunKeeper use with additional     physiotherapy coaching in improving patients' leisure-time PA compared with usual care in     cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12     and 26 weeks.   "
12033|NCT03128320|"     The purpose of the study is to analyse skin blood flow in diabetic patients with peripheral     artery disease. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg     BAY1193397. The analysis of safety and tolerability are secondary objectives of this study.   "
12034|NCT03128307|"     Online patient registration to participate in clinical trial to test OTC mouthpiece that     controls position of the tongue to reduce snoring.   "
12035|NCT03128294|"     In this study we would like to explore the patient and tumour characteristics of long-term     survivors of ovarian cancer (>10 years). Indentifiying the characteristics of long-term     survivors not only helps find prognostic factors for survival but may aid in generating     hypotheses for novel therapeutic strategies.   "
12036|NCT03128281|"     The goal of this clinical research study is to compare the level of pain 2 hours after     surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low     pressure setting or the standard insufflator (the conventional insufflation system, or CIS).     Insufflation is the creation of a pressure barrier of air/gas within the abdomen that     allows the surgeon more space to work in.   "
12037|NCT03128268|"     This study aims to evaluate the effectiveness of 4D image acquisition and post-processing     with Vios Works for the evaluation of 3D images acquired on GE Magnetic Resonance Imaging     scanners. Specifically, the investigators propose to evaluate the following:        1. Image acquisition time using traditional 2D and new 4D processing techniques;        2. Image quality for 2D and 4D processing techniques subjectively        3. Post-processing time for the two techniques.        4. Correlation of overall Left ventricular and right ventricular volumes and functions and          aortic and pulmonic flow studies using the two techniques.        5. The study will monitor any changes in patient diagnoses or treatment resulting from any          differences in interpretations between the two processes.   "
12038|NCT03128255|"     Regular thyroid diagnostics versus augmented thyroid work-up with additional I-124 PET/US     fusion for metabolic-sonographic nodule allocation in patients with benign thyroid diseases   "
12039|NCT03128242|"     This study aims to investigate oxytocin's effect on attentional bias training. Healthy     participants will undergo a dot-probe task-based training to direct their attention away from     negative stimuli (as compared to neutral). Effects of the training will be assessed using an     eye-tracking anti-saccade task.   "
12040|NCT03128229|"     The overarching goals of this study are to determine whether tubular dysfunction (elevated     urine sodium, bicarbonate and amino acids) and injury (elevated kidney injury molecule 1     [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL] and matrix metallopeptidase 9     [MMP9]) exist in new onset diabetic ketoacidosis (age 3-18), whether it is reversible and     whether it is related to uricosuria and copeptin. The investigators propose to study a cohort     of youth (ages 3-18, n=40) with new onset T1D who have serum and urine collection at DKA     diagnosis and 3-month follow-up.   "
13342|NCT03110900|"     The primary objective of this study is to determine the noninferiority of inhaled loxapine     compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.   "
12043|NCT03128190|"     Background: Intraoperative fluid therapy guided by mechanical ventilation-induced     pulse-pressure variation (PPV) may improve outcomes after major surgery. It was tested this     hypothesis in a multi-center study.      Methods: The patients were included in two periods: a first control period (control group;     n=147) in which intraoperative fluids were given according to clinical judgment. After a     training period, intraoperative fluid management was titrated to maintain PPV< 10% in 109     surgical patients (PPV group). It was performed 1:1 propensity score matching to ensure the     groups were comparable with regard to age, weight, duration of surgery, and type of     operation. The primary endpoint was postoperative hospital length of stay.   "
12044|NCT03128177|"     The purpose of this study is to determine if high salt diet contributes to high nighttime     blood pressure. The investigators will determine if high compared to low salt diet increases     24-hour blood pressure levels. The investigators will also determine if high salt diet     affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also     determine how high salt diet affects the activity of certain genes related to control of     blood pressure. A total of 60 participants will be enrolled in the study.   "
12045|NCT03128164|"     This is a Phase 1, open-label study of HMPL-689 administered orally to patients with lymphoma     for whom failed of standard care or have no standard of care.This study will consist of a     dose escalation stage (Stage I) and a dose expansion stage (Stage II).   "
12046|NCT03128151|"     The NMB (Neuromuscular Blockade) is the most frequent complication in anesthesiology     associated with an increase in adverse respiratory events in the postoperative period. Its     appearance depends on multiple factors. The introduction of a comprehensive educational     strategy aimed at promoting the proper management of NMB in the intraoperative period and a     package of measures that must be performed (intraoperative neuromuscular monitoring and     reversal of the effect of neuromuscular blockers) may contribute to a decrease in the     incidence of NMB, Increase safety in the surgical patient and decrease associated costs.   "
12047|NCT03128138|"     1. To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD)          characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy          volunteers.        2. To explore the appropriate dose and provide the basis for the subsequent clinical          trials.   "
12048|NCT03128125|"     The main objective of this study is to determine whether children with high intellectual     potential have gestural and / or executive difficulties compared to control children.   "
12049|NCT03128112|"     This is a multi-site, cross-sectional study of 3-8 year old children and their parents     presenting for a well-child check. The investigators are assessing whether a novel,     educational, exam room poster can effectively prompt parents to ask their pediatricians about     their children's weight status and improve parents' perceptions of their children's weight     status.   "
12050|NCT03128099|"     Social impairments are core features of schizophrenia that lead to poor outcome. Social     skills and competence improve quality of life and protect against stress-related exacerbation     of symptoms, while supporting resilience, interpersonal interactions, and social affiliation.     To improve outcome, we must remediate social deficits. Existing psychosocial interventions     are moderately effective but the effort-intensive nature (high burden), low adherence, and     weak transfer of skills to everyday life present significant hurdles toward recovery. Thus,     there is a dire need to develop effective, engaging and low-burden social interventions for     people with schizophrenia that will result in better compliance rates and functional outcome.      The investigators will test the effectiveness of a novel adaptive virtual reality (VR)     intervention in improving targeted social cognitive function (social attention, as indexed by     eye scanning patterns) in individuals with schizophrenia. VR technology offers a flexible     alternative to conventional therapies, with several advantages, including a simplified and     low-stress social interaction environment with targeted opportunities to simulate, exercise     and reinforce basic elements of social skills in a very wide range of realistic scenarios,     and to repeat exposure to naturalistic situations from multiple angles.   "
12051|NCT03128086|"     After a period of mechanical ventilation, a spontaneous breathing trial is performed before     extubation in order to assess the patient's ability to breathe. In neurological patients a     spontaneous breathing trial can not predict the success of extubation. The extubation failure     is associated with a longer intensive care unit stay and hospital stay, as well as more     infections and higher mortality.      The purpose of this study is to demonstrate that the use of a protocol-directed weaning in     neurological patients reduces the rate of extubation failure and associated complications.   "
12052|NCT03128073|"     The study is a proof-of-concept, a feasibility study of peritoneal ultrafiltration with a     wearable device, Carry Life System Ultrafiltration (CLS UF) and will be performed on 4-6     stable peritoneal dialysis (PD) patients without clinical signs of dehydration. The study     session starts with an initial fill of the abdomen, with a standard, glucose based PD     solution. The CLS UF device is then connected to the patients existing, PD catheter. A     Glucose-salt solution is added to 180 ml of the intraperitoneal fluid which is intermittently     transferred from the peritoneal cavity through a closed system using the CLS UF cycler and     then returned to the patient. The addition of the Glucose-salt solution maintains a stable     intraperitoneal osmolarity and compensates for the glucose uptake and dilution which occurs     in standard PD treatments.   "
12053|NCT03128060|"     This study will test the effectiveness of integrating an evidence-based model of home-based     palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The     investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill     patients (and approximately 884 family caregivers) who receive primary care from 10 regional     accountable care organizations (ACOs) in California to one of two study groups: HBPC or     enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with     patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate,     following the death of the patient.   "
12054|NCT03128047|"     The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely     used in pediatric patients with high-grade glioma, both alone and in combination with     standard chemotherapy medications.   "
12086|NCT03127631|"     RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer.     RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying     cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.   "
12055|NCT03128034|"     This phase I/II clinical trial studies the side effects and best dose of     211^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with     high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.     Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8,     can bind to cancer cells and give off radiation which may help kill cancer cells and have     less of an effect on healthy cells before donor stem cell transplant.   "
12056|NCT03128021|"     The Department of Psychiatry at the University of Pittsburgh is conducting a research study     to learn about the changes that occur in the brain when individuals suffer from and then are     treated for depression. The NEMO study has two main purposes. The first is to provide     medication treatment to individuals ages 60 and older who are currently depressed.     Participants are randomly assigned to either receive an FDA-approved medication for     depression or a placebo (also known as a sugar pill) for at least 6 weeks. The antidepressant     medication that investigators use in this study is called Lexapro. Up until 6 weeks, this is     considered to be a double-blinded study meaning neither participants nor the study     investigators will know whether they are taking Lexapro or placebo. After 6 weeks, the blind     is broken for participants who are not responding to the treatment. This means that both     participants and the investigators will then find out which which was prescribed. At that     point, there are three possibilities: 1) participants taking placebo will have the     opportunity to try the Lexapro, 2) participants may continue taking the Lexapro, or 3)     participants will be referred for alternate treatments if their depression symptoms have not     resolved while taking Lexapro.      The second part of the study involves completing a series of up to 6 MRIs, which assess     changes in brain function over the course of treatment. This research may help investigators     to develop faster and more effective treatment plans in the future, as brain responses that     are detected early in treatment may predict how well an individual will respond to     antidepressant medication.   "
12057|NCT03128008|"     This is a prospective phase II study designed to evaluate an accelerated and adaptive RT     approach for locally-advanced non-small cell lung cancer (NSCLC). All eligible subjects will     have an interim PET-CT during radiation therapy to determine the metabolic complete response     rate. Radiation therapy will be given in an accelerated fashion (2 Gy/fraction, 6     fractions/week) with concurrent chemotherapy. Interim responses will be assessed using     PERCIST criteria.      Despite concurrent chemotherapy and radiation therapy, local/regional failure occurs in ~50%     of patients with locally-advanced NSCLC. Clinical studies have demonstrated that accelerated     fractionation (giving the same total dose in a shorter period of time) improves outcomes in     several malignancies, including lung cancer. Administering higher than conventional doses of     RT to all sites of original disease leads to inferior outcomes. Adapting the RT approach,     giving a higher dose to slowly responding disease as assessed with interim PET has been shown     to be feasible. PERCIST (Positron Emission Tomography Response Criteria in Solid Tumors)     provides guidelines on how to report responses to therapy based on PET-CT. PET-CT response     has been shown to be prognostic in a variety of clinical scenarios in lung cancer including     after induction therapy. In one study, PET was performed after neoadjuvant chemoradiotherapy     (40-50.4 Gy). Complete or partial metabolic response using PERCIST criteria was predictive of     loco-regional, distant, and overall progression-free survival.   "
12058|NCT03127995|"     The standard treatment of localized breast cancers consists of surgical removal of the tumor     at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or     axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or     thoracic wall and the lymph node areas from 5 to 6.5 weeks.      Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement     have been equally effective and have no more side effects in several clinical trials     involving several thousand patients. This called hypofractioned radiotherapy has become a     standard for breast cancers in the absence of lymph node involvement in postmenopausal women.      The objective of the HypoG01 trial is to evaluate hypofractioned radiotherapy in women who     require radiotherapy in the breast or chest wall and lymph node areas by comparing standard     over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side     effects and in particular the risk of lymphedema (swelling of the arm on the side treated)     and the effectiveness of these treatments   "
12059|NCT03127982|"     The present study aims at evaluating the effects of a CBT intervention, a cultural adaptation     of the Unified Protocol for the Trans-diagnostic Treatment of Emotional Disorders (UP) in     victims of the Colombian armed conflict.      A randomized clinical trial aimed at evaluating the effects of the UP in a group of 100     internally displaced victims of armed conflict living in Bogotá is being implemented.     Participants are recruited from several governmental, non-governmental agencies as well as     community organizations of victims. Participants are being randomly assigned to treatment     condition (N=50) or to waiting-list control (N=50). Treatment consists in 12 biweekly     sessions covering the 8 modules of the original UP. The effects of the UP is evaluated     through Patient Health Questionnaire (PHQ) and several measures of co-morbid emotional     disorders, Anxiety, Depression, PTSD as well as level of functioning and quality of life.   "
12060|NCT03127969|"     The objective of this study is to evaluate the efficacy of fluidotherapy primarily on     function and quality of life, secondarily on pain, morning stiffness, grip strength, and     disease activity in patients with rheumatoid hand.Ninety-three patients were enrolled in this     prospective, single-blind, randomized, and controlled trial. Patients were randomized into 2     groups. Group 1 (n=47) had fluidotherapy (5 times per week, for 3-week duration) and Group 2     (n=46) was the control group. All patients received joint protection and exercise program.     The primary outcome measures were Health Assessment Questionnaire (HAQ) and Duruöz Hand Index     (DHI) and secondary outcome measures were pain and morning stiffness assessed using the     Visual Analog Scale (VAS, 0-100 mm), the Grip Ability Test (GAT), Disease Activity Score-28     (DAS-28), and grip strength. These assessments were performed at baseline, at week 3 and week     12 after treatment.   "
12061|NCT03127956|"     The objectives of this study are to assess the long-term safety of Olumacostat Glasaretil     gel, 5.0% in patients with acne vulgaris   "
12062|NCT03127943|"     Assess the clinical impact of Buffered 1% lidocaine with epinephrine as compared to the     Non-buffered 1% lidocaine with epinephrine in dental and oral surgical procedures.   "
48363|NCT02652572|"     The purpose of this study is to determine the systemic exposure of Granexin® gel after     topical application to human subjects' venous leg ulcers.   "
12065|NCT03127904|"     The objective of this Bayesian Adaptive trial is to compare a control group versus a     comprehensive ulcer healing protocol. The latter involves a combination of compressive     therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump     among patients with lower extremity venous ulcers. The investigators hypothesized that the     combined therapy will have a higher closure rate as well as lower time to closure.   "
12066|NCT03127891|"     TITLE: EFFECT OF SHORT TERM PRANAYAMA ON ANAESTHESIA MANAGEMENT IN PATIENTS UNDERGOING     CARDIAC SURGERY      Primary aim: To evaluate the effect of pre-operative short term pranayama yoga on stress     induced hemodynamic (HR, MAP) changes in patients scheduled for cardiac surgery.      Secondary aims:        1. To compare the effect of YOGA on pre operative anxiety.        2. To compare effect of Yoga on SPO2.        3. To compare effect of Yoga on total consumption of propofol administered using Closed          Loop Anaesthesia Delivery system(CLADS)        4. To compare effect of Yoga on total consumption of fentanyl, vecuronium, vasopressors and          inotropes        5. To compare effect of Yoga on post-operative pain scores , total analgesic consumption          and post-operative anxiety (after extubation in CTVS ward)        6. To compare effect of Yoga on post-operative outcome in terms of duration of mechanical          ventilation, duration of ICU stay, incidence of complications and post-op mortality   "
12067|NCT03127878|"     Background: Despite recent recommendations for the inclusion of upper-limb endurance training     in exercise training programs (ET) for patients with COPD, the majority of theses programs     are yet focused only in lower-limb endurance training. However, these patients may have a     hindered performance during the execution of simple activities of daily living (ADL)     involving the upper-limbs. Therefore, one doubt remains: is the addition of upper-limb     endurance training necessary? Aims: To verify whether patients with COPD become more     physically active in daily life, as well as whether they improve ADL performance after two     protocols of ET: 1) traditional ET (TET; endurance exercises of the lower-limbs and     strengthening exercise for upper- and lower-limbs) and 2) TET + additional upper-limb     endurance exercise (AULET). Methods: Patients with COPD (n= 64) will be included in this     randomized controlled clinical trial. Before randomization to TET or AULET patients will be     evaluated regarding physical activity in daily life (PADL; accelerometers), lung function     (plethysmography), respiratory muscle strength (maximum ins- and expiratory pressures), body     composition (bioelectrical impedance), performance in ADL (Londrina ADL protocol), maximum     exercise capacity (symptom limited maximum test of lower and upper limbs), submaximal     exercise capacity (endurance time at 80% of the maximum upper- and lower-limb capacity),     functional exercise capacity (six-minute walk test and six-minute pegboard and ring test),     peripheral muscle strength (one-repetition maximum test and dynamometry), healthy-related     quality of life (Chronic Respiratory Questionnaire), health status (COPD assessment test),     functional status (London Chest Activity of Daily Life scale) and symptoms of anxiety and     depression (Hospital Anxiety and Depression Scale). Patients in both groups will exercise     three times per week for 12 weeks. TET will be composed by endurance exercise for the     lower-limbs (walking on treadmill and lower-limb cycling) plus strengthening exercises for     upper- and lower limbs. Group AULET will perform the same exercises plus the additional     upper-limb endurance training (upper-limb cycling). Patients will be evaluated by the same     procedures after the ET. Hypothesis: The addition of upper-limb endurance training will     increase PADL and ADL performance to a greater extent than the traditional exercise-training     program alone due to greater reduction of physical activity-related dyspnea.   "
12068|NCT03127865|"     The purpose of this study is to compare the sensitivity and the specificity of electrical     cardiometry to the lung ultrasound in measuring thoracic lung water in pregnant females with     pre-eclampsia. If electrical cardiometry is validated against ultrasound, it will be easy to     use with numerical number that will not require advanced experience as with the ultrasound.   "
12069|NCT03127852|"     Remote patient monitoring is a potential component for the management of chronic conditions     that may provide reliable and real-time physiological measurements for clinical decision     support, alerting, and patient self-management. The purpose of this study is to evaluate an     UHN-built remote monitoring system for patients with complex chronic conditions called Medly.   "
12070|NCT03127839|"     Patients seeking care for shoulder pain will be recruited to enroll will be randomized to one     of four combined treatment groups; eccentric or traditional strengthening alone and eccentric     or traditional strengthening with pain neuroscience education. Patients will be followed for     1 year.   "
12071|NCT03127826|"     This is a trial to validate the use of the STarT Back Screening Tool (SBST) in the Military     Health System for patients with low back pain presenting to primary care.   "
12072|NCT03127813|"     Lowering of the pressure in the eye (intraocular pressure, IOP) is the only proven treatment     for Primary Open-angle Glaucoma (POAG). However, even effective reduction of IOP by     pharmacological or surgical means does not always change the course of the disease or prevent     the onset of glaucoma. Some people with POAG also suffer from Obstructive Sleep Apnoea (OSA),     an increasingly common sleep disorder which is known to affect heart and blood vessels, and     may contribute to glaucoma progression. OSA is treated with Continuous Positive Airway     Pressure (CPAP); however using this type of breathing support may raise IOP.      This study aims to establish whether a short-term application of CPAP in awake subjects leads     to an increase in IOP. Patients with treated POAG, patients with newly diagnosed untreated     POAG and control subjects without glaucoma will be included. CPAP will be applied at several     different pressure levels for a total of 2 hours during which IOP and ocular perfusion     pressure (OPP) will be measured. If CPAP is shown to raise IOP or alter OPP it could be     necessary to assess available alternative treatment options for OSA.   "
12073|NCT03127800|"     The aim of this study is to investigate the effects of morphine (a drug commonly used for the     treatment of moderate to severe pain, particularly following surgery) on the number of pauses     in breathing in patients with moderate obstructive sleep apnoea (OSA). Morphine has been     shown to reduce upper airway muscle tone and can also cause shallow breathing, which can     affect breathing function in patients with sleep apnoea. However, to date these effects have     not been proven in clinical trials. Although, caution is advised when prescribing morphine to     patients with sleep apnoea, there is currently no strong evidence that morphine makes sleep     apnoea worse. Only one randomised controlled trial (considered the gold standard in medical     research) has shown no worsening of symptoms for patients with sleep apnoea. The effect of     morphine on patients with sleep apnoea will be assessed in a safe, controlled, hospital     environment. Information from the study will help inform doctors about the safety of giving     morphine to patients with sleep apnoea in urgent situations, for example after surgery.      The results of this study will enable clinicians to make better decisions when prescribing     this drug to patients with OSA in the future.   "
12074|NCT03127787|"     The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the     management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study     is to establish the clinical performance of the DxN CMV Assay for plasma samples in the     intended use population.   "
12087|NCT03127618|"     Information relating to requesting compassionate access for this investigational drug can be     found at the following link:      http://www.pfizer.com/research/compassionate_use   "
12075|NCT03127774|"     Objectives:      - To determine intraperitoneal (IP) progression free survival after optimal debulking and     heated intraperitoneal chemotherapy (HIPEC) with cisplatin in patients with IP spread of     adrenocortical cancer.      - Determine morbidity of this procedure in this patient population.      - Determine the impact of surgery and HIPEC on quality of life (QOL) and hormone excess.      - Examine patterns of recurrence (local versus systemic).      - Determine overall survival after optimal debulking and HIPEC in patients with IP spread of     adrenocortical cancer.   "
12076|NCT03127761|"     Multiple myeloma (MM) is the second most common hematologic malignancy in adults. The current     standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an     autologous HCT (autoHCT). Allogeneic HCT (alloHCT) is the only potentially curative therapy     available to patients with MM. However, the significant morbidity and mortality of this     procedure historically limited its application in older patients.      Thus, although potentially curative, standard risk MM patients have excellent prognoses in     the era of novel therapies which reduces the overall benefit of alloHCT. However, because the     outcomes for high-risk MM remain poor despite the best available standard therapies (overall     survival of 24-36 months), initial data suggest that alloHCT should be explored in this     subset.   "
12077|NCT03127748|"     With advances in interventional cardiac catheterization, ventricular septal defect (VSD)     could be successfully treated via transcatheter device closure. Cardiac catheterization team     of National Taiwan University Children's Hospital has recently treated more than 60 patients     with VSD using this technique. Both treatment effect and follow-up results were encouraging.     Of particular notice is that many patients experienced subjective improvement in exercise     tolerance after VSD closure. Traditionally, VSD could only be repaired by open-heart surgery     under cardiopulmonary bypass. Therefore, VSD closure would be considered only for those with     moderate to large defect, significant heart failure, or presenting with significant exercise     intolerance. With the success in transcatheter closure of VSD, a procedure which is safer and     leading to faster recovery comparing to cardiac surgery, device closure of VSD would be a     reasonable and sensible treatment of choice if it is beneficial for long-term cardiac     function and exercise performance.      This project will prospectively enroll 50 patients with VSDs subject to transcatheter closure     of the defect in our institute. Before device closure and 6 months after closure,     participants will be assessed with image studies (including speckle tracking and tissue     Doppler echocardiography), measurements of serum biomarkers (including B-type natriuretic     peptide and biomarkers of collagen metabolism), and standard cardiopulmonary exercise test.     The purpose of this study is to investigate the potential benefits of closing VSD with     respect to cardiac function and exercise performance, which might serve as basis to redefine     future indication of VSD closure.   "
12078|NCT03127735|"     To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1     (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics,     pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced     acute myeloid leukemia (AML)   "
12080|NCT03127709|"     The purpose of this study is to try to understand how histopcytosis can cause symptoms or     problems in the brain. The tests being done in the study will look at memory and thinking as     well as brain function via MRI scan.   "
12144|NCT03126799|"     Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab     is significantly necessary for developing new standard treatment in first-line therapy in     Korean EGFR mutant NSCLC patients.      In this study, The investigators will investigate the efficacy and safety of Erlotinib and     Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.   "
12081|NCT03127696|"     Faecal microbiota transplantation (FMT) represents a clinically feasible way to restore the     gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent     Clostridium difficile infection. Furthermore, clinical trials are being conducted to evaluate     its use for other conditions including inflammatory bowel disease, irritable bowel syndrome,     diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. Early results in     human have shown that FMT from lean donor when transplanted into subjects with metabolic     syndrome resulted in a significant improvement in insulin sensitivity and an increased in     intestinal microbial diversity, including a distinct increase in butyrate-producing bacterial     strains. The therapy is generally well tolerated and appeared safe. No clinical studies have     assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.   "
12082|NCT03127683|"     The influence of different head and neck positions on the effectiveness of ventilation with     the Ambu AuraGain airway remains unevaluated.      This study aimed to evaluate the influence of different head and neck positions on     ventilation with the AuraGain airway.      An AuraGain will be placed in all patients, and mechanical ventilation will be performed     using a volume-controlled mode with a tidal volume of 10 ml/kg.      The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and     ventilation score will be assessed first for the neutral head position and then for the     extended, flexed, and rotated head positions in a random order.   "
12083|NCT03127670|"     Solanum melongena is a common vegetable contains phytochemicals which prevent, reduce or     delay the oxidation of DNA and alter the cellular signal transduction pathways controlling     cell proliferation and apoptosis of human cancer. The skin of Solanum melongena peel contains     nasunin an anthocyanins and chlorogenic acid which have anti-inflammatory, antioxidant,     antimutagenic and antiangiogenic properties. Extract of Solanum melongena is used in actinic     keratosis and Squamous cell carcinoma of the skin. This study will determine any change in     arsenical skin lesion after administrating Solanum melongena extract cream.   "
12084|NCT03127657|"     Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation     injection and oral supplementation for osteoarthritis. Hyaluronic acid acts as humectants and     topical moisturizing agent to the skin due to excellent moisturizing property. It has     anti-inflammatory effect and used in the treatment of ulcer healing and to reduce the     intensity of radioepithelitis. It is also used as a topical vehicle for the delivery of drug     to the skin in actinic keratosis. In the case of arsenical keratotic nodule, topical     application of hyaluronic acid may tends to decrease keratosis by repeated hydration of the     skin. Therefore, the study will be conducted to determine any beneficial effect of topical     application of cock's comb extract in the treatment of the patients with severe palmar     arsenical keratosis.   "
12090|NCT03127579|"     The goal of this study is to test whether a longer meal duration could improve the diet     quality of children. To answer this question we want to take an experimental approach by     implementing a longer family meal duration to examine differences in children's eating     behavior. The family dinner within a laboratory setting will be video taped and the main     outcome is children's fruit and vegetables consumption.   "
12091|NCT03127553|"     The purpose of this clinical study is to evaluate the health properties of a dietary     intervention carried on with an innovative low-salt bread.      The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may     improve the compliance to the own regime and that the vascular function, the inflammatory and     oxidative state, the composition of the intestinal microbiota and that neurocognitive and     neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with     low-salt bread.   "
12093|NCT03127475|"     Different conditions of gait ignition freezing, spontaneous freezing during walking and     turning freezing on encountering obstacle will be investigated in fMRI study to examine     whether different regions of brain will be involved under different conditions of freezing.     We hypothesize that anterior cortical regions will engage in gait ignition failure, deep     locomotion regions will be responsible for spontaneous freezing and schema regions will be     involved in the generation of turning freezing on seeing the barrier. In the third part of     the project, we will deliver a 5-day session of transcranial direct current stimulation     (tDCS) to the motor cortex of the FOG patients to examine whether the intervention will     benefit the patients. Based on the signal source findings, we will investigate whether the     possible tDCS beneficial effect will be different or similar in patients with different     electric sources. In addition, how long the possible beneficial effect of tDCS can be     consolidated after the 5-day course of stimulation is crucial and requires to be elucidated     under the research project. We aim to peep the myth of FOG in PD by the multi-modality     approach and hope the study will benefit the long suffering patients.   "
12145|NCT03126786|"     The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA     used with intravitreal aflibercept in subjects with DME.   "
12146|NCT03126773|"     To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13     cycles of treatment.   "
12094|NCT03127462|"     60 newly referred patients with psoriasis at the Department of Dermatology and Allergy,     Herlev and Gentofte Hospital, Denmark will be consecutive included in the study. In the first     phase of the study 30 patients will receive standard treatment (control group) and in the     following phase 30 patients will receive the individualized conversational/educational     intervention (intervention group).The rationale for using a historical control group instead     of a randomised control group is that it inreal-life setting is unpractical to realize a     communicative intervention, because clinicians unintentional can intervene against the     control group.      The first conversation will take place when the newly referred patient has initiated a new     treatment. The rational for this is that the time of transition from private practice to the     Department of Dermatology and Allergy is characterised by failed treatment, typically     phototherapy or topical. This meaning that newly referred patients current needs is to get     their psoriasis under control. When patients have initiated a medical treatment they will be     more motivated and have better surplus to engage in the conversational/educational     intervention.      Patients in the intervention group will receive an individual face-to-face conversation with     a duration of 45 min. All patients will have access to telephone counselling by their primary     nurse when needed and able to arrange a new face-to-face conversation. After 4-6 weeks the     face-to-face the nurse will of conversation reach out to the patient by phone to follow up on     the earlier conversation. Three months after the face-to-face conversation the nurse will     offer the patient a closing face-to-face conversation of 15 min at the same time where the     patient has a doctor appointment at the department. Those who are in the control group will     continue standard care and not receive any conversation and be used as the control group.      The intervention will be provided by a team of specialized dermatological nurses who have     received a formal training on patient-centred communication, Self-regulatory Model/Common     Sense Model interviewing, the life with chronic disease and action plan support.   "
12095|NCT03127449|"     This study is conducted to assess the safety, tolerability and preliminary efficacy of     AST2818 in patients with advanced Non Small Cell Lung Cancer (NSCLC).   "
12096|NCT03127436|"     Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy     With Acarovac® Hausstaubmilbe   "
12097|NCT03127423|"     Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical     ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation     (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes.     However, there were no randomized, controlled clinical studies to prove the effectiveness of     this new strategy. This study is aimed to compare the outcomes of hybrid ablation with     video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.   "
12098|NCT03127410|"     The objective in this study is to determine the predictive validity of a set of special     clinical tests in identifying those who will respond to lumbar traction   "
12099|NCT03127397|"     This study evaluates the effects of praise message phone calls on antiretroviral therapy     (ART) initiation, adherence, and prescription refills. The investigators will use     randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs)     in Ethiopia to a praise message phone call study arm or to a standard of care control study     arm.   "
12100|NCT03127384|"     The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for     treatment of depressed facial acne scars   "
12101|NCT03127371|"     This study aims to describe the safety and efficacy of adjunctive nitrous oxide to lidocaine     anesthesia in decreasing pain in adults during incision and drainage (I&D) of cutaneous     abscesses in the emergency department (ED). Incision and drainage has been considered one of     the more painful procedures performed in the ED. Standard care recommends a minimum of local     anesthesia, however, there is no consensus on the appropriateness of pain management during     ED painful procedures, such as incision and drainage. Oligoanalgesia continues to be a     problem for ED health care providers. Despite extensive research in mechanisms of pain,     factors relating to inadequate pain management, and evidence-based pain management     strategies, implementation of effective pain management in the ED is still lacking. Nitrous     oxide is a weak sedative agent with analgesic and anxiolytic properties. Rapid onset and     short duration of action, ease of use, and favorable cardio-respiratory profile makes it an     ideal agent for analgesia in the ED and may provide a novel strategy for pain management in     I&D. While it has been studied an adjunct to laceration repair in children and labor in     women, the use in the ED setting is not known. Adult patients capable of consenting, with     simple cutaneous abscess requiring incision and drainage are the targeted population.     Eligible patients who consent to the study will be randomized to one of two groups: nitrous     oxide/local anesthesia or oxygen/local anesthesia. Primary endpoints assessed will be pain     scores using the VAS at baseline, ten minutes after NO administration, immediately post I&D     procedure, and ten minutes after procedure completion. Additionally, secondary endpoints of     patient and physician procedure satisfaction scores, total time of nitrous oxide used, and     presence of adverse events, including respiratory depression defined by peripheral SaO2 below     92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, the loss of the     ETCO2 waveform for more than 15 seconds. The vital signs, medical conditions, demographics,     and abscess dimensions will also be collected.   "
12481|NCT03121430|"     Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial     femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical     performance compared with similar products already on the market.   "
12102|NCT03127358|"     People who Inject Drugs (PWIDs) constitute 60% of the approximately 5 million people in the     United States infected with hepatitis C virus (HCV). Successful HCV treatment leading to     sustained viral response (SVR) is associated with increased survival, but to date successful     treatment of PWIDs has been limited. Treatment of PWIDs is complex due to addiction, mental     illness, poverty, homelessness, lack of positive social support, poor adherence-related     skills, low motivation and knowledge, and poor access to and trust in the health care system.     At Albert Einstein College of Medicine, the investigators have developed a multidisciplinary     model of HCV care that integrates on-site primary care, substance abuse treatment, and     HCV-related care within opiate agonist treatment clinics. To optimize HCV treatment outcomes,     the investigators have introduced directly observed therapy (DOT). In our DOT model, one     daily dose of oral HCV medication is administered with methadone. However, DOT is not     feasible for PWIDs who are not enrolled in methadone maintenance treatment programs, and is     less effective for methadone-maintained PWIDs who do not attend the methadone clinics every     day. In addition, DOT has been used for decades both to measure and maximize adherence for     treatment of tuberculosis infection, but the cost and logistical complexity of administering     DOT for large HCV clinical programs would be prohibitive.   "
12103|NCT03127345|"     This is a randomized clinical trial comparing Omegaven® treatment with standard of care     (soybean-based lipid formulation, Intralipid®) on bone health outcomes in infants with     esophageal atresia (EA) undergoing surgical repair at Boston Children's Hospital.   "
12104|NCT03127332|"     The overarching objective of this study is to close clinical knowledge and performance gaps     by providing oncology clinicians with the latest advances and emerging research in the     evidence-based and personalized treatment of metastatic breast cancer patients. In addition,     the research team seeks to meet quality measures relevant to value-based care delivery     through IT infrastructure and clinical workflow processes. The research team also hopes to     gain insights into clinician practice patterns related to metastatic breast cancer, and the     correlation between the reported goals of care for patients with metastatic breast cancer,     and the patients' fit/frailty status and treatment decisions.   "
12105|NCT03127319|"     The purpose of this study is to assess the efficacy and safety of patients who receive     apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line     treatment for advanced EGFR wild type non-squamous non-small cell lung cancer with bone     metastases.   "
12106|NCT03127306|"     Between 40 to 70% of patients with critical illness experience moderate to severe pain.     Diagnosing pain and assessing its severity is difficult in non-verbal patients both in an     Intensive Care Unit and in Postoperative Unit after a major surgery such as cardiac surgery).     In patients who are unable to self-report pain, we use behavioural pain scales, namely BPS -     Behavioural Pain Scale.      Aim: The aim of this study was to validate the Polish version of a behavioural pain     assessment method - BPS in intubated, sedated patients after cardiac surgery versus self     assessment of pain using Numeric rating scale (NRS) in both delirious and non-delirious     patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).      Method: A prospective observational cohort study will include 60 patients. The patients will     be observed by two trained observers during a nociceptive procedure (position change), both     during analgosedation and analgesia. Patients will be observed 5 minutes before, during, and     15 min after the two sets of interventions (six assessments in total). Each BPS assessment     will be carried out by two observers blinded to each other. To validate the Polish BPS     translation we will use the following methods: calculations of interrater reliability,     criterion validity and discriminant validity.   "
12107|NCT03127293|"     Hyperemesis Gravidarum (HG) is a common disorder for hospitalization in the first trimester     of pregnancy and related to protracted vomiting and nausea. It can be accompanied by     ketonuria, dehydration and weight loss. Our aim was to investigate osteoporosis in patients     with HG. In our study, we investigated osteoporosis in a total of 79 patients (40 HG and 39     control) by means of dual energy x-ray absorptiometry (DEXA) measurements and laboratory     parameters related to HG.   "
12108|NCT03127280|"     This is a randomized comparative trial investigating two different catheter management     strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic     surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or     urinary tract surgery was concurrently performed, will be randomly assigned to either     conventional urinary catheter care removal on post-operative day 1 or same day surgery     urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including     urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks     following the index surgery.   "
12109|NCT03127267|"     The objective is to compare the efficacy and safety of masitinib in combination with riluzole     versus corresponding placebo in combination with riluzole in the treatment of patients     diagnosed with Amyotrophic Lateral Sclerosis (ALS).   "
12110|NCT03127254|"     The purpose of this study is to learn more about the content of and benefits of making video     testimonials in adolescents with cancer.   "
12111|NCT03127241|"     Restore a lost function is a special experience for people affected by neuromuscular     evolutive diseases. From the patient's point of view improvement is measured by regaining     lost abilities,-by being able to do something -anything-today I couldn't do yesterday .     Upper limb pain, stiffness and activity limitations have a crucial role in reducing patients'     autonomy and worsening quality of life.      Real users' needs have been identified thought several workshops, and even if the commercial     products might assure a benefit to some users and meet most of their requirements, so far a     validation of the use of such devices by people with neuromuscular disease is missing.      We aim at field-testing the improvement in arm functions provided by the use of some     commercial devices and assessing their impact to users' quality of life and independence.     This step is essential to assure a widespread accessibility to these devices for most of the     potential users, possibly providing health providers with direction and guidance towards     Health Technology Assessment.      Clinical Trial design - The study proposes on-field validation of JAECO WREX, passive     antigravity exoskeleton; and Armon Ayura, motorized arm exoskeleton for gravity compensation     in a randomized controlled trial with crossover design. The clinical study will is     multi-centric, involving both MEDEA and VALDUCE, and received the Ethical Committee approval.   "
49292|NCT02640729|"     This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual     hallucinations in subjects with Lewy body dementia.   "
12112|NCT03127228|"     The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser,     Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard     mechanical debridement to ablate the infected tissue around the dental implant and detoxify     the contaminated implant surface for resolving peri-implant infection and enhance bone     regeneration of peri-implant defects.   "
12113|NCT03127215|"     Evaluation of the efficacy of the combination of olaparib and trabectedin in adult patients     with locally advanced/metastatic solid tumors that failed standard treatment and whose     molecular sequencing tumor profiles show homologous recombination repair (HRR) defects. The     primary objective is to show superior disease control rate in patients with HRR-deficient     tumors treated with olaparib and trabectedin compared to treatment according to current     guidelines (physician's choice). This trial aims to establish whether the PARP-dependency of     HRR-deficient tumors across entities can be exploited for therapeutic benefit.   "
12114|NCT03127202|"     Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve     stimulation.   "
12115|NCT03127189|"     The main purpose of this study is to characterize the single-dose pharmacokinetics (PK) of     rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral     formulation (RPV LA) nanosuspensions with different particle size distribution (PSD), in     healthy adult participants.   "
12116|NCT03127176|"     The gut microbiota is a complex community comprising around 10^14 bacteria that live in the     gut lumen. The imbalance of the normal structure and function of the microbiota, defined as     dysbiosis, has been related to a wide diversity of pathologies, including mental health     disorders. However, clinical evidence of the relationship between microbiota and mood     disorders is lacking. The aim of this project is to examine the possible relationship of gut     dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and     of gut dysbiosis and cognitive impairment in bipolar patients.   "
12117|NCT03127163|"     To determine whether the implantation of an intrastromal corneal ring is an effective     treatment for a homogeneous group of mild keratoconus patients.   "
12118|NCT03127150|"     With the development of pancreatic surgery, the surgeon has put more emphasis on chylous     fistula as the postoperative complications in recent years. The diagnostic criteria and     treatment methods about chylous leakage have been developed and improved in clinical     practice. However, there remains controversy about the high risk factors and efficient     control measures during the perioperative period.   "
12119|NCT03127137|"     Cervical radicular pain is relatively common, often treated with epidural steroid injection     (ESI), when conservative treatments like oral analgesics, physical therapy and activity     modification have failed. There are no universal clinical practice guidelines for the use of     diluents when CESI are performed.      Interlaminar CESI may be performed with or without the use of local anesthetics, due to     training bias or theoretical concerns of weakness. CESI without the benefit of local     anesthetic as a steroid diluent increases the latency of pain relief and may decrease     diagnostic information immediately after a CESI with regard to pain generators responsible     for symptoms, and may potentially decrease patient satisfaction.      By evaluating the effects of local anesthetic as a diluent during interlaminar cervical ESI,     we will enhance the safety of this treatment with regard to expectations of objective motor     weakness as well as post procedure pain control and patient satisfaction in the recovery     phase after the injection procedure.      Research Question:      Does lidocaine versus saline as a steroid diluent effect objective upper extremity strength     following cervical epidural steroid injection in patients being treated for cervical     radiculitis?      Null Hypothesis:      Cervical epidural steroid injections that include local anesthetic as a diluent have no     effect on objective upper extremity strength following the injection.      We hypothesized that cervical epidural lidocaine will cause an objective decrease in strength     in functional movements of the upper extremity.   "
12120|NCT03127124|"     This is a phase 1b/2 study to evaluate the safety and efficacy of NANT-008 in combination     with 5-fluorouracil, bevacizumab, leucovorin, and oxaliplatin in patients with metastatic     pancreatic adenocarcinoma.   "
12121|NCT03127111|"     The goal of this laboratory research is to look for genetic and epigenetic markers that can     predict which patients with stage III colorectal cancer will benefit from fluorouracil-based     adjuvant chemotherapy.   "
12122|NCT03127098|"     This is a phase 1b/2 study to evaluate the safety, tolerability, and efficacy of ETBX-011     vaccine used in combination with ALT-803 in subjects with locally advanced or metastatic     CEA-expressing cancers whose tumor has recurred after standard-of-care treatment.   "
12123|NCT03127085|"     Patients with a history of atrial fibrillation (AF) who frequently attend the emergency     department (ED) with symptoms may not require emergency treatment, and may be more     appropriately managed in an alternative outpatient setting. This may be the result of     inappropriate or inadequate advice or a lack of patient understanding. The main research     objective pertains to the reason for seeking medical attention for AF in the ED, ED     management of the patient, outcomes of ED care and alternative strategies.   "
12124|NCT03127072|"     To date no prospective trials have been completed that demonstrated whether RFA is an     effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in     overall survival compared with chemotherapy (target therapy) alone. The primary objective of     this trial is to determine overall survival for patients with colorectal cancer liver     metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy,     compared to chemotherapy ± target therapy only.   "
12125|NCT03127059|"     Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe,     can mimic or exaggerate asthma. Around every forth patient with asthma have DB. Breathing     exercises (BrEX) can improve asthma-related quality of live (QOL) in less severe asthma. No     study has investigated the effect of BrEX on QOL neither on level of physical activity in     severe asthma.      A randomised controlled multicentre trial will include 220 adults with poor asthma control     (Asthma Control Questionnaire (ACQ6)-score≥1.5) from five outpatient departments. Patients     will be allocated to either usual care (no intervention) or breathing exercises     (BrEX)-treatment consisting of 12-week intervention including three physiotherapist-sessions     focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and     activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma     Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up.   "
12127|NCT03127033|"     Conventional complete overdenture will be made to ectodermal dysplasia patients, a week after     delivery and after 3 months Patient satisfaction, retention and periodontal condition will be     assessed. the denture will be taken from the patient for 2 weeks.Acrylic telescopes will be     replaced with soft liner and again Patient satisfaction, retention and periodontal condition     will be assessed a week after delivery and 3 months later.   "
12128|NCT03127020|"     The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the     Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of PQR309     administered orally, as once daily capsules continuously and on intermittent schedule, in     patients with relapsed or refractory lymphomas.   "
12129|NCT03127007|"     The study has a phase Ib and a phase II part. The phase Ib part of the study aims to     determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks,     concomitantly to the standard preoperative radio-chemotherapy.      The phase II part of the study aims to explore efficacy of atezolizumab in combination with     the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.   "
12130|NCT03126981|"     The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice     daily on insulin sensitivity and markers of cardiometabolic health in men and women with     prediabetes.   "
12131|NCT03126968|"     Bleeding poses potential for significant complication after transbronchial lung biopsies. The     investigators hypothesize that prophylactic intrabronchial instillation of topical     epinephrine will reduce the likelihood of bleeding. The investigators plan a double-blind,     placebo controlled trial to evaluate this hypothesis.   "
12147|NCT03126760|"     This is a multicenter, multiple dose study to estimate the response rate, and examine the     safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose     steroids. Approximately 66 subjects will be randomized.   "
12148|NCT03126747|"     This study is a Japanese post-marketing surveillance (PMS) which is required by the     regulatory authorities. General objective of PMS is to confirm the clinical usefulness,     especially the safety profile of a drug under the routine clinical practice.   "
12214|NCT03125889|"     A single-arm prospective, interventional clinical trial to evaluate the safety and     performance of obtaining hemostasis following prostate resection using the AQUABEAM for     treatment of LUTS resulting from BPH.   "
12132|NCT03126955|"     Our team recently described a new medical condition called HELPS     (Hemi-Laryngo-Pharyngeal-Spasm) syndrome(1). HELPS syndrome is a condition caused by a blood     vessel pinching the nerve rootlets of the Vagus nerve (Xth cranial nerve). It is similar to     the well recognized hemifacial spasm syndrome but the nerve involved is the Vagus instead of     the Facial nerve. As a result, the symptoms are episodic throat contractions and cough. The     throat contractions become stronger and more frequent over the years and can lead to a     terrifying inability to breath. Patients may end up intubated in the Emergency Department or     with a tracheostomy because of inability to breath during a severe episode. Some but not all     of our patients can tell which side of their throat (left or right) contracts during a     choking episode. In between these choking episodes, patients feel normal. A surgical cure for     these patients is Microvascular Decompression of the Xth nerve.   "
12134|NCT03126929|"     This study aims to provide, in a large sample, further psychometric data as regards the     internal consistency, the test-retest reliability and the diagnostic validity of the Coma     Recovery Scale-Revised (CRS-R).   "
12135|NCT03126916|"     This partially randomized phase III trial studies iobenguane I-131 or crizotinib and standard     therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or     ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation     directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or     crizotinib and standard therapy may work better in treating younger patients with     neuroblastoma or ganglioneuroblastoma.   "
12136|NCT03126903|"     To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis     when implanted in an eye with corneal opacity that is at high risk of complications with PK.   "
12137|NCT03126890|"     Linezolid is the second line agent in the treatment of MRSA and PRSP infections, and it is     also the drug of choice for VRE infections. It can be an alternative option against multidrug     resistant tuberculosis and non-tuberculosis mycobacterium. However, Patients who receive more     than 2 weeks of treatment duration and who have renal dysfunction or severe cirrhosis may     prone to experience anemia, thrombocytopenia, and leukopenia. Long-term use may also result     in lactic acidosis, peripheral neuropathy and optic neuropathy due to mitochondrial toxicity.     Thus, this study will analysis the medical charts in National Taiwan University Hospital     (NTUH) from 2011 to 2016 to get the population demographics who use linezolid and analysis     the occurrence rate of myelosuppression, neuropathy and lactic acidosis. Simultaneously, the     investigators also use therapeutic drug monitoring (TDM) to prospectively evaluate the     association of linezolid blood concentration and clinical efficacy and safety. The result of     this study will provide physicians more information to prevent concentration-dependent     adverse effects.   "
12138|NCT03126877|"     The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the     improvement of near vision in presbyopic patients with treatments to optimize the ocular     surface before corneal inlay surgery.   "
12139|NCT03126864|"     The goal of this clinical research study is to learn about the safety and tolerability of 3     different doses of CD33-CAR-T cells (referred to throughout the consent as T-cells) in     patients who have CD33-positive acute myeloid leukemia (AML) that is relapsed (has come back)     or refractory (has not responded to treatment).      CD33-CAR-T is made by genetically modifying (changing) your T-cells (a type of white blood     cell). T-cells are genetically changed to help target leukemia cells.   "
12161|NCT03126578|"     This is a single center, non-randomized, open-label, fixed sequence study to investigate the     effect of multiple oral dosing of LEO 32731 (up-titrated), on CYP3A activity in healthy male     subjects using midazolam as a probe CYP3A substrate.      The study will be conducted in two seamless parts:      Part I - Maximal Tolerated Dose (MTD) Part II - Drug-Drug Interaction with midazolam   "
14496|NCT03095716|"     The primary purpose is to evaluate the quality of post-operative recovery and post-operative     pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine     prolapse.   "
12140|NCT03126851|"     This study seeks to identify ways to help parents safely use cough/cold medications with     their children. The study focuses on 3 key tasks that have been found to be difficult for     parents: 1) decision-making about whether medicines should be given based on a child's age,     2) use of active ingredient information to determine which medications are safe to give     together, and 3) medication dosing.      Specific ways that labels and dosing tools can be changed to improve parent understanding and     ability to use pediatric cough and cold medications will be tested. This includes looking at     whether including age restriction information on the front panel helps parents make better     decisions about whether a medication should be given to a child, as well as whether presence     of a specific warning or pictogram can help improve this understanding. In addition, the role     of font size, including a box around ingredients, and use of a specific warning to look at     and compare active ingredients, will be examined to see if these can help parents decide if     two medications can be given together safely. Finally, dosing charts with pictograms of     dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.      A label/dosing tool combination that incorporates what is learned from the first part of the     study will be developed based on findings from the first part of the study, and then tested     to see whether this improves parent understanding and use of pediatric cough and cold     medicines.      Hypotheses include: 1) changes in labels and dosing tools, such as including explicit     warnings, and pictographic warnings/instructions can improve parent understanding and ability     to act on of medication instructions, 2) parents with low health literacy and/or LEP will     especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3)     parents receiving the comprehensive labeling and dosing strategy will have a better     understanding of appropriate use of cough/cold medications, including fewer dosing errors,     compared to standard labels.      A multi-part experiment will be conducted. Findings will be merged with known evidence around     health literacy best practices to develop a comprehensive, consumer-centered strategy for     English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in     comparison to existing labels will then take place.   "
12141|NCT03126838|"     This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its     effect on outcome of surgery.   "
12142|NCT03126825|"     Acute in-booth assessment of a new noise reduction algorithm with cochlear implant     recipients.   "
12143|NCT03126812|"     This is a single arm feasibility study in patients with primary FIGO stage IV serous ovarian,     peritoneal, or fallopian tube cancer to evaluate neo-adjuvant + adjuvant pembrolizumab for     its capacity to induce and broaden T cell responses against tumor neo-antigens.   "
12215|NCT03125876|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) of CT053PTSA in Relapsed/refractory AML patients with FLT3 gene     mutation.   "
12151|NCT03126708|"     This is an open-label, randomized, controlled trial. At the end of a 28-day screening period,     all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio.     Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus     paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by     the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive     clinical benefit will continue treatment with cetuximab as monotherapy until either PD or     unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A     alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.   "
12152|NCT03126695|"     To evaluate the relative bioavailability of ticagrelor for the different formulations. A     randomized cross-over design has been chosen to minimize the effects of between-subject     variability and any period effects on the overall results.   "
12153|NCT03126682|"     The purpose of the study is to examine the effect of bupropion on seizure threshold and     duration in depressed patients receiving right unilateral ultra-brief electroconvulsive     therapy (ECT). The investigators plan to recruit 10 patients into the study, administer     sustained release (SR) bupropion 4 hours prior to receiving ECT. The investigators plan to     compare the seizure threshold and seizure durations between ECT sessions with and without     bupropion administration. The study's implication is to examine how ECT can be optimized by     rational combination with medications that lower seizure threshold.   "
12154|NCT03126669|"     The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, less     than 10% of the brain is active at every given time, the brain utilizes almost all the oxygen     delivered. In order to perform different tasks or more than one task (multi-tasking), the     oxygen supply is shifted from one brain region to another, via modulation of blood perfusion.      The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment,     with increased oxygen supply to the brain, will enable better performance of complex and/or     multiple activities.      Methods: a prospective, double blind randomized control, cross over trial including healthy     volunteers. Participants were asked to perform a cognitive task, a motor task and a     simultaneous cognitive-motor task (multi-tasking). Participants were randomized to perform     the tasks at 2 environments: (a) normobaric air (1ATA 21% oxygen) (b) HBO (2ATA 100% oxygen).     Two weeks later participants were crossed to the alternative environment. Blinding of the     normobaric environment was achieved in the same chamber with masks on while hyperbaric     sensation was simulated by increasing pressure in the first minute and gradually decreasing     to normobaric environment prior to tasks performance.   "
12155|NCT03126656|"     The main of the study is to evaluate the effect of testosterone on ventricular repolarization     in patients with mild heart failure, at risk for sudden cardiac death. The     electrocardiographic markers studied are QT variability index, the short term variability     index.   "
12156|NCT03126643|"     At BMS, we work with physicians/investigators to make investigational products available to     patients with life-threatening diseases that have exhausted other treatment options and where     there is a reasonable expectation of benefit over risk.      When contacted by a treating physician, BMS will consider requests for providing early     patient access to Nivolumab in pediatric patients exhibiting a high mutational load.   "
12157|NCT03126630|"     This randomized phase I/II trial studies the side effects and how well pembrolizumab with or     without anetumab ravtansine work in treating patients with mesothelin-positive pleural     mesothelioma. Monoclonal antibodies, such as anetumab ravtansine and pembrolizumab, may     interfere with the ability of tumor cells to grow and spread.   "
12158|NCT03126617|"     At BMS, we work with physicians/investigators to make investigational products available to     patients with life-threatening diseases that have exhausted other treatment options and where     there is a reasonable expectation of benefit over risk.      When contacted by a treating physician, BMS will consider requests for providing early     patient access to Elotuzumab in patients with multiple myeloma who are residents of Belgium,     Thailand, Turkey, Argentina, and Colombia.   "
12159|NCT03126604|"     A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years     after normal vaginal delivery or Cesarean section   "
12160|NCT03126591|"     The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in     participants with previously treated advanced or metastatic soft tissue sarcoma.   "
12253|NCT03125382|"     Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in     patients with implantable cardiac desfibrilator (ICD)   "
12162|NCT03126565|"     This study is being done to evaluate the impact of a system called CareSage. The CareSage     system is a technology that uses clinical data to monitor, identify and target care to     patients at risk of being transported to the hospital. The investigators want to see whether     the CareSage system is effective in helping to identify hospital admissions which can be     prevented.   "
12163|NCT03126552|"     Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae     once and will retain infection for up to 2 years.   "
12164|NCT03126539|"     This study aims to compare the expression of keratins before and after application of     sulforaphane (SF) to determine whether this agent alters skin fragility seen in both     intrinsic and extrinsic skin aging and UV light exposure.   "
12165|NCT03126526|"     This research project aims to explore the effectiveness of a computerised intervention as a     treatment for eating disorders, particularly binge eating disorder and bulimia nervosa. Two     interventions will be used to target cognitive processes: 1) food-specific inhibitory control     training and 2) implementation intentions.      The full intervention is 4 weeks long and consists of completing the training and food     diaries every day and meeting with the researcher twice for EEG recording and taste tests.     Moreover, it involves completing questionnaires at baseline, at intervention completion, and     one month after the intervention.      Moreover, healthy control participants will be recruitment to complete baseline     questionnaires and take part in one EEG recording session in order to assess baseline     differences in brain activation in response to computer tasks.   "
32842|NCT02855944|"     The purpose of this study is to determine how patients with ovarian, fallopian tube, and     primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.   "
12166|NCT03126513|"     Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a     mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral     endoscopic myotomy (G-POEM) is a new treatment that has demonstrated initial promising     results in these patients. The investigators aims are to evaluate security and efficacy of     this endoscopic treatment in participants with refractory gastroparesis.   "
12167|NCT03126500|"     Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a     high risk for functional limitations, impaired muscle strength and reduced quality of life.   "
12168|NCT03126487|"     This is a non-randomized, prospective phase II trial evaluating an innovative treatment,     focused MRI-guided ultrasound, as thermic destruction in primitive small size breast cancer.   "
12169|NCT03126474|"     Wrist (distal radius fractures) are very common injuries. Despite this there is still much     controversy about the best way to treat them and in particular which ones require     intervention. Many studies have been carried out but there is no strong evidence to answer     these questions. The investigators are carrying out a Delphi study which involves seeking     consensus from experts at treating these injuries about the best way to manage them. UK and     international expert surgeons will take part in three rounds of online questionnaires to help     decide how much displacement of the fracture will trigger treatment for different common     wrist fracture cases. The aim of the study is to obtain expert opinion through consensus from     the expert group about the amount of displacement that is acceptable until intervention is     required.      This will provide guidance and reduce variation between treating surgeons.   "
12170|NCT03126461|"     A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced     metastatic melanoma patients   "
12171|NCT03126448|"     The purpose of this research project is to improve understanding of the potential role of     highly sensitive bacterial tests in diagnosing infected non-healing fractures compared to the     current standard of care, microbiologic culture (growing bacteria from tissue specimens in     the laboratory).      In order to understand the validity of the highly sensitive tests, parameters of the test in     different groups of patients must be established. This study is examining how two highly     sensitive tests compare to each other and to the standard of care (microbiologic culture) in     three groups of patients.      Group 1 is clean broken bone surgery undergoing plate and screw fixation, intramedullary     nailing fixation where the fracture site is accessible, or staged treatment of a broken bones     initially treated by joint spanning external fixation device. Group 2 will include patients     having a plate and screws removed without clinical evidence of infection. Group 3 will be     patients undergoing an initial procedure for fracture nonunion.   "
12172|NCT03126435|"     The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of     EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients     with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.   "
12173|NCT03126422|"     The investigators aimed to investigate the effects of pretreatment with different doses of     dexmedetomidine on the cough caused by fentanyl during anesthetic induction.      Patients undergoing elective surgeries under general anesthesia will be randomly allocated to     4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be     pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the     induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and     severity of cough that occurred within 2 min after the injection of fentanyl will be     recorded, and the incidences of cardiovascular adverse events that occurred between the     administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be     recorded.   "
12174|NCT03126409|"     This study evaluates the short-term patency of vein graft harvested by the No-Touch technique     compared to that by the conventional approach in patients undergoing isolated on-pump     coronary artery bypass graft (CABG) surgery. a total of 1500 patients undergoing isolated     on-pump CABG will be consecutively recruited from 6 hospitals across China and randomly     assigned to receive No-Touch saphenous vein harvesting or conventional approach. All     participants will be invited for clinical follow-up and 64-slice multislice computed     tomography angiography (MSCTA) analysis at 3 months post-operatively.   "
12175|NCT03126396|"     Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous     or mixed leg ulcers.   "
12176|NCT03126383|"     The AMISS study will characterize the features of muscle disease in patients with primary     Sjogren's syndrome (pSS).   "
14497|NCT03095703|"     The aim of the study is to investigate the effect of sirolimus on the progression of     intestinal adenomas in patients with FAP and to assess the safety of this treatment.   "
12177|NCT03126370|"     This study evaluates the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the     pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide.     Subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus     (HIV), and also taking a ritonavir or cobicistat boosted protease inhibitor who are     initiating LDV/SOF treatment for Hepatitis C virus (HCV) will be invited to participate. The     study consists of seven visits: a screening visit and three abbreviated 4-hour     pharmacokinetic visits, and three standard of care visits (week 8 and 12 of LDV/SOF treatment     and one visit to assess cure).   "
12178|NCT03126357|"     This study will examine elements of abuse liability (AL) related to potential product     adoption of three electronic tobacco vapor products by current smokers relative to high and     low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in     subjective measures, speed and amount of nicotine uptake, and maximum changes in     physiological effects during and after product use that follows a 12-hour (minimum) tobacco     and nicotine abstinence period, will be determined. The electronic tobacco vapor products     will not be compared to each other.   "
12179|NCT03126344|"     This study was designed to determine the comparison between the King Vision video     laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal     intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision     group [n=30]、 McGrath MAC group [n=30] and Macintosh group[n=30]were intubated using     respective devices.This study is the first to search the use of King Vision video     laryngoscope for nasotracheal intubation.   "
12216|NCT03125863|"     A single-arm prospective, interventional clinical trial to evaluate the safety and     performance of obtaining hemostasis with commercially approved catheters following prostate     resection using the AquaBeam for treatment of LUTS resulting from BPH.   "
12180|NCT03126331|"     This study is being done with patients with advanced kidney cancer (also called renal cell     carcinoma or RCC). This is a research study involving the use of the drug Nivolumab (also     known as Opdivo®). Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking     a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the     immune system and controls parts of the immune system by shutting it down. Antibodies that     block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing     it to recognize and help destroy cancer cells. In many countries (including the United     States, European Union and Japan) Nivolumab is approved to treat certain cancer types. The     purpose of the study is to test the safety and effectiveness of nivolumab in patients with     advanced RCC when given intermittently.      Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of     advanced kidney cancer, non small cell lung cancer, classical Hodgkin Lymphoma and Metastatic     Melanoma. Nivolumab is FDA-approved for advanced RCC because has been shown to shrink RCC     tumors that have spread outside the kidney.   "
12181|NCT03126318|"     This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,     pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo     administered subcutaneously to patients with moderate-to-severe chronic kidney disease and     persistent inflammation.   "
12182|NCT03126305|"     The clinical component of Phase I application development examines the clinical utility,     feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting     of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving     treatment through the pediatric OCD treatment programs in the UCLA Division of Child and     Adolescent Psychiatry   "
12183|NCT03126292|"     The objective of this study is to conduct a 12-month pilot longitudinal study of a     parent-directed program delivered in a primary care setting serving primarily low-income     families. The parent-direction program will be evaluated in a randomized controlled design to     determine the feasibility of protocol implementation and to investigate the potential impact     on parental outcomes. Process outcomes will include success with recruitment, participant     retention, and ability to collect outcome measures. Clinical outcomes will incorporate     measures of parental self-efficacy and parenting behaviors, including observational     assessments of parent-child interactions.   "
12184|NCT03126279|"     Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative     temporal summation, a measure of central pain facilitation, has been shown to predict     postoperative pain after total knee replacement surgery (TKR). The assessment of the brain's     response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in     identifying imaging biomarkers within the brain that map central sensitization changes seen     in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop     persistent post-operative pain. To test these concepts the study aims to functionally     characterise the brain activity related to temporal summation of pain in healthy individuals     and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain     and function will be performed 6 months post TKR surgery   "
12185|NCT03126266|"     This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine     glioma (DIPG)   "
12186|NCT03126253|"     Childhood anemia is a global public health problem that is associated with life-threatening     consequences such as growth retardation, impaired motor and cognitive development, and     increased morbidity and mortality. Anemia can be caused by a variety of factors such as     nutritional deficiencies (i.e., iron, folic acid, vitamin B12, and vitamin A), infections     (i.e., helminth), and blood disorders (i.e., hemoglobinopathies). The World Health     Organization (WHO) estimates that approximately 50% of anemia cases can be attributed to iron     deficiency. This is an estimated global average that varies widely depending upon the     location in question. The World Bank estimates for 2011 claim that approximately 55.60% of     all Bangladeshi children under five years of age are suffering from anemia. The relationship     between socioeconomic status (SES) inequality and anemia among the children has never been     conclusively and it is unclear if the children of the age group of 6-59 months have uniformly     high levels of anemia during all the stages of development, e.g., during the infant, toddler,     and preschool stages. In addition, there is a dearth of evidence from Bangladesh, where the     meaning of sociodemographic characteristics may be different from that in other countries.     Therefore, this study attempts to fill the above-mentioned lacuna by investigating and     evaluating the association of SES inequality, among other explanatory variables, on the     development of childhood anemia during different stages of child development and to answer     the questions: (a) Is SES a factor impeding childhood anemia along with other explanatory     variables? (b) In which stage of child development, the chance of disparaging with childhood     anemia is highest? (c) Is there evidence of between child development stages differences in     the strength and form of association disparities between having childhood anemia and SES? (c)     What are the predictive margins for SES-associated anemia in the case of infants, toddlers,     and preschool children? The results of this analysis will be reported for elucidating the     potential effects of SES and the stages of child development that are usually neglected in     the conventional scientific literature. Moreover, as anemia is one of the current key health     issues in Bangladesh, it is also expected that the findings of this study would contribute     significantly toward shaping the health policy strategy of the country.   "
12187|NCT03126240|"     The increasing prevalence of obesity noticed in recent decades is a major public health     problem of pandemic nature. According to researches, there will be 2.3 billion overweight     adults and more than 700 million people suffering from obesity worldwide by the year     2020.Series of epidemiologic studies has revealed a relative link between morbid obesity and     metabolic syndrome type 2 diabetes mellitus, hypertension, hyperlipidemia, insulin resistance     and shorter life span. Dyslipidemia specially when combined with obesity significantly     increase the incidence of atherosclerosis and its complications and also insulin resistance     and hence control of diabetic patients. Hyperlipidemia is widely recognized as one of the     main co- morbidities in severe obesity and major risk factor for development of     atherosclerosis and then heart related diseases.Bariatric surgery has become a prominent     treatment modality after the rapidly increasing prevalence of obesity.   "
12188|NCT03126227|"     This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101     using the characterized oral desensitization immunotherapy (CODIT ™) regimen in     peanut-allergic children.   "
12189|NCT03126214|"     The purpose of this study is to compare the effectiveness of prescribing oral anticoagulation     therapy by pharmacist intervention compared to enhanced usual care in participants with     unrecognized AF and/or known AF but not taking blood thinners.   "
12190|NCT03126201|"     Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular     diseases leading to end stage renal disease. In this study, our aim is to evaluate the     effects of histopathological, clinical, and laboratory features of patients with primary FSGS     on the disease progression.   "
12192|NCT03126175|"     For the non-surgical treatment of distal radius fractures in adults a variety cast options     are available, including or not the elbow joint. The literature is inconclusive regarding the     need to immobilize the elbow joint after reduction of the distal radius fracture.This study     was undertaken to evaluate the best method of immobilization between the above and     below-elbow cast groups at the end of 6 months of follow-up.   "
12193|NCT03126162|"     The objective of this study is to determine if backfilling the bladder immediately     post-operatively, prior to removal of the foley catheter, in patients undergoing same-day     total laparoscopic hysterectomy will hasten time to first spontaneous void and time to     discharge   "
12194|NCT03126149|"     The current study is the first clinical trial proposed with PF-06667272. It is designed to     evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of     PF-06667272 under fed and fasted conditions, in healthy adult subjects.   "
12195|NCT03126136|"     Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset     fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in     women with a low admission pulse pressure than those with a normal admission pulse. The aim     of the present study is to look for a statistical link between the occurrence of a fetal     heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure,     pulse pressure, and cardiac output) measured before epidural analgesia in two positions:     dorsal decubitus position and in the left lateral decubitus.   "
12196|NCT03126123|"     Anal condylomatosis is an anal canal mucosa pathology caused by HPV infection (Human     Papilloma Virus). This condition is common, especially in immunodepressed patients.      These lesions are not accessible to topical medical treatment because of their location. They     should be treated surgically because they may degenerate into squamous cell carcinoma.      In the operating room, lesions are identified by a complete proctologic examination, more or     less supplemented by an acetic acid test. Acetic acid allows to detect mucous degeneration     (dysplasia) in the form of intense bleaching. The interpretation of this test may     nevertheless be difficult in case of local inflammation or scarring. These false positives     may lead to unnecessary surgical gestures. The surgical procedure consists of a mucosectomy     or destruction of the condylomatosis by electrocoagulation.      The acetic acid test is used at the discretion of the surgeon. However, there is little data     on its performance or consensus on its use.   "
12197|NCT03126110|"     The purpose of this study is to determine the safety, tolerability, and efficacy of     INCAGN01876 when given in combination with immune therapies in subjects with advanced or     metastatic malignancies.   "
12199|NCT03126084|"     This study compares analgesic effectiveness of transversus abdominis plane block and     quadratus lumborum block type 2 in open hernia repair surgery. All of the patients will     receive routine intravenous analgesic regimen. In addition to that one-third of the patients     will receive transversus abdominis plane block, one-third will receive quadratus lumborum     block type 2. One-third of the patients will not receive any blocks and will constitute the     control group   "
12200|NCT03126071|"     The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy     plus bevacizumab in the treatment of advanced colorectal cancer   "
12201|NCT03126058|"     This study is aimed to evaluate the safety of applying enhanced recovery after surgery for     colorectal cancer.   "
12202|NCT03126045|"     Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as     well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a     common complication for patients and is characterized by the occurrence of a headache with an     orthostatic component, with additional symptoms such as nausea. Some studies in neurology,     anesthesia and gynecology have previously shown a decreased incidence for post lumbar     puncture headache while using atraumatic needles as compared to standard needles. In this     context, it is necessary to better document the incidence of post lumbar puncture headache     with the use of atraumatic needles in hematologic patients.   "
12203|NCT03126032|"     Aim of the study is to evaluate to what extent a glycocalyx damage measured in the ER in     patients presenting with sepsis correlates with their clinical course and if it can be used     as a clinical stratification tool and mortality predictor.      The study will focus on the changes of the microcirculation and how they correlate with the     macrocirculation, as well as microbiologic parameters. In the study will participate ca. 300     patients with sepsis, as well as 30 patients without sepsis and 30 healthy individuals.   "
12205|NCT03126006|"     The main objective of this study is to determine whether the provision of non-surgical     periodontal therapy to pregnant women with periodontitis is effective in reducing the     incidence of low birth weight, preterm birth and still birth when compared to pregnant women     with periodontitis but who will be provided with oral hygiene instructions alone.   "
12217|NCT03125850|"     This study will compare the glaucoma day-ward patients' efficacy with inpatients by     evaluating the glaucoma knowledge, psychology, effect of surgery and complications , and will     analysis the reasons of the differences. Half of participants will receive treatment in     day-ward, while the other half will receive treatment in hospital.   "
12218|NCT03125837|"     Difficult airway is a major reason of anesthesia related injuries with latent life     threatening complications. Foresee difficult airway in the preoperative period is vital for     the patient's safety. The aim of this study is to develop a computer algorithm that can     detect whether the patient is a difficult airway based on photographs form six aspects. This     method will be decreased potential complication related to difficult airway and increased     patient safety.   "
12219|NCT03125824|"     To further evaluate accelerated fading resulting from additional treatment sessions of     Soliton AWD as accessory to laser in tattoo reduction treatment.   "
12220|NCT03125811|"     This study will compare two different ways to relieve nausea and vomiting in the Emergency     Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies     have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.   "
12206|NCT03125993|"     1.Objective      The investigators aim to determine the effect of brisk walking prescription (> 10000 steps, >     five days, per week) on body components and metabolic risk factors among patients with     overweight/obesity. The objectives are as follow:        1. The body components changes before/after the brisk walking prescription (> 10000 steps,          > five days per week) intervention in overweight/obesity population;        2. The metabolic risk factors changes before/after the brisk walking prescription (<10000          steps or <five days per week) intervention in overweight/obesity population      2.Study design This study is a prospective 4-month follow-up scheme in which patients were     treated with the following intervention: > 10000 steps, > five days, per week. For individual     follow-up, body components and metabolic risk factors will be tested before and after the     study. Every participants will be followed up in community visits every month.      3. Statistical analysis Statistical analysis will be performed using SPSS 16.0 version     package (SPSS Inc., Chicago, IL.). Numerical data will be presented as mean ± standard     deviation for normal distribution or otherwise median (interquartile range). Two-sided     independent t-test is adopted for between-group comparison on end-points with normal     distribution, otherwise non-parametric test. Row-Column table will be analyzed through     chi-square test. P<0.05 is taken as statistical significant.   "
12207|NCT03125980|"     Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer.     However, more and more studies have found better efficacy and potential advantages of     perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received,     the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy     may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and     thus reducing operational trauma and expediting recovery. With advances in radiology and     tomography, staging before surgery is accurate enough to identify risks and prognosis for     patients. The phase II trial conducted by our department has yielded encouraging results     (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy,     no subject had disease progression, 68.1% subjects reached complete or partial response.     Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present     randomized controlled phase III trial will be conducted to further compare efficacy and     safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced     resectable colon cancer in China. This study may have two periods, each will last for     approximately 5 years. After the first period (n=994), if the results of the test group are     better than the control group, the study will be terminated. Otherwise, the study will enter     into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the     same trial process as period 1.   "
12208|NCT03125967|"     The purpose of this study is to assess the safety and efficacy of daily morning exposure to     colored light in patients receiving acute inpatient rehabilitation services for stroke,     traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor     nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized     placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing     the effects of daily morning exposure to either blue light or red light on objective sleep     quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms,     fatigue, and neurological symptoms.   "
12209|NCT03125954|"     This is an objective cohort study using objective recording of physical activity     (accelerometry) during and after the GLAiD intervention to investigate if a sedentary     behavior change by participating in an 6-week physiotherapy-led exercise and education     program (GLAiD) occurs. The GLAiD intervention is an education and exercise based     intervention aiming at decreasing pain and improving function in patients with knee     osteoarthritis.      The primary outcome is change in objective recorded physical activity between baseline and     follow-up.   "
12210|NCT03125941|"     The aim of this study is to investigate the effect of a single preoperative high-dose steroid     injection on complications in the immediate postoperative phase after breast cancer surgery,     with removal of the breast (mastectomy). Primary outcome is the proportion patients who     require transfer to the post anaesthesia care unit (PACU) and the proportion that can be     transferred directly to the ward. Secondary outcomes are organspecific complications in the     postanasthesia phase, pain and nausea the first 5 days, seroma and wound infection the first     14 days and readmissions the first 30 days after surgery.      The investigators hypothesize that the frequency of transfer to the PACU and organspecific     complications will be lower among patients receiving high dose dexamethasone. The     investigators hypothesize, that there will be no difference in wound infections, seroma or     readmissions.   "
12266|NCT03125213|"     This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study     evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with     Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are     treatment-naïve.      The study will consist of a screening phase , a double-blind treatment phase followed by     treatment with Peg-IFN alone, and a post-treatment follow-up phase.      Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2     treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:        -  Arm A: Peg-IFN plus AL-3778 (N=20)        -  Arm B: Peg-IFN plus matching placebo (N=10)   "
12211|NCT03125928|"     This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of     atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with     locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to     concerns that corticosteroids may have a negative effect on tumor immunity expected with     addition of atezolizumab to the standard of care regimen, patients will receive premedication     with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid     premedication will be discontinued subsequently.      Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally     recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1.     Tumor measurements and bone scans will be performed every 9 weeks while patients are on     study.   "
12212|NCT03125915|"     The proposed study developed and tested two adjunct components for use in Couples HIV Testing     and Counseling (CHTC) with gay-male couples: a communication skills training video and a     substance use agreement module. Phase I of the study involved the creation of intervention     materials and Phase II was comprised of a small randomized controlled trial comparing the     additive effects of the novel components to CHTC as usual.   "
12213|NCT03125902|"     This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to     evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand     1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in     combination with paclitaxel in participants with previously untreated, inoperable locally     advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1     ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or     unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 45     months).   "
12221|NCT03125798|"     Surgical treatment of lung cancer consists of two elements: anatomical lung resection     (segmentectomy, lobectomy or pneumonectomy) followed by mediastinal lymph node dissection     (MLND). Since over last 15 years the growing rate of resection is performed by minimal     invasive approach - video-assisted thoracoscopic surgery (VATS). The study is focused on the     clinical and technical aspects of MLND during VATS lobectomy. The extension of lymph nodes     resection is strictly specified. The main benefit of MLND for the patient is precise     histopathological staging, which allows choosing the best therapeutic option of adjuvant     therapy. MLND is related with potential minor and major complications (bleeding, increased     volume of chest tube drainage, prolonged chest tube duration and hospital stay, chylothorax,     left recurrent laryngeal nerve injury, injury of the bronchus, injury of the esophagus). The     majority of complications are caused by thermal injury resulting from the use of     heat-generating monopolar electrocautery that is commonly used during lymph nodes dissection.     In addition, thermal energy generation in case of monopolar electrocautery may lead to     systemic inflammatory response and increased surgical injury. High-energy sealing devices     like LigaSure™ allow for dissection, coagulation and cutting with the single instrument.     Compared to mechanical ligation techniques (vessel loops, clips) or monopolar electrocautery,     LigaSure™ technology has been shown to reduce: intraoperative blood loss (in colorectal,     gynecologic and urologic surgery), surgery time (in colorectal, gynecologic and urologic     surgery), length of hospital stay (in gynecologic and urologic surgery). Investigators     hypothesize that application of LigaSure™ in VATS anatomical resection may lead to diminished     complications rate, lower systemic inflammatory response and shorter length of stay compared     to monopolar electrocautery.   "
12222|NCT03125785|"     Patients with congenital cataract operated at St. Erik Eye Hospital are given the topical     steroid dexamethasone (Isopto-Maxidex) according to a set treatment plan. They are provided a     contact lens made of the polymer Filcon 4A that is frequently replaced due to the results of     previous in vitro studies that have shown accumulation of preservatives in the hydrogel     contact lens matrix which could question their use in combination with ophthalmic solutions.     We conducted a pilot study that indicate that the results in vivo are different from the     results in vitro and we suspect that insignificant amounts of dexamethasone and benzalkonium     chloride are taken up by the lenses due to tear drainage.      Contact lenses from 30 patients at St. Erik Hospital that have undergone surgery for     congenital cataract and are treated with eye drops containing dexamethasone and benzalkonium     chloride will be collected and analyzed. Ultraviolet-Visible spectrophotometer (UV-vis) and     Laser desorption ionization-mass spectrometry (LDI-MS) will be used to study uptake and     release of dexamethasone and benzalkonium chloride. Scanning electron microscopy (SEM) will     be used to study surface morphology. Thirty Contact lenses from a control group without     topical treatment will also be analyzed. Data will consist of contact lens material, wearing     time, pharmaceutical agents, contact lens solution when applicable, diagnosis and possible     co-morbidity.   "
12223|NCT03125772|"     The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to     assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary     artery disease undergoing coronary revascularization. Approximately 1,830 patients with     single or multi lesion, multi vessel coronary artery or saphenous vein graft disease ranging     in vessels ranging from 2.25 mm to 4.0 mm in diameter by visual estimate will be enrolled in     a 1:1 randomization to TAXUS Element™ vs. XIENCE™ Prime in India at up to 50 clinical sites,     to demonstrate the safety and effectiveness of TAXUS Element™ in an unrestricted population.      Procedural Endpoints:        -  Device success, defined as attainment of < 30% residual stenosis of the target lesion          (visual assessment) using the TAXUS Element™ or XIENCE™ Prime stent.        -  Lesion success defined as attainment of < 30% residual stenosis (visual assessment)          using any percutaneous method.        -  Procedure success defined as lesion success without the occurrence of in-hospital MACE.        -  Procedure complication rate including composite and individual angiographic occurrence          of dissection ≥B, distal embolization, no reflow, slow flow, abrupt closure, or          perforation.   "
12224|NCT03125759|"     This observational study aims to research whether there is a relationship between omentin and     ischemic stroke on the aspects of incidence, severity, and recovery etc.   "
12225|NCT03125746|"     1. To evaluate the safety and tolerability of LXI-15029 in Chinese patients with advanced     malignant solid tumors in monotherapy period, including confirmation of the maximum tolerated     dose (MTD) of monotherapy. 2.To evaluate the safety and tolerability of LXI-15029 in Chinese     postmenopausal patients with metastatic or locally advanced breast cancer with estrogen     receptor (+) and human epidermal growth factor receptor 2 (-) in combined with Exemestane     period , including confirmation of the maximum tolerated dose(MTD) of the combined therapy     with Exemestane.   "
12267|NCT03125200|"     This study evaluates ADCT-502 in patients with Advanced Solid Tumors with HER2 Expression.     Patients will participate in a dose-escalation phase (Part 1) and dose expansion (Part 2). In     Part 2, patients will receive the dose level identified in Part 1.   "
16306|NCT03072030|"     The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety     of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus     Disease, 0.5 ml+0.5 ml/dose   "
12226|NCT03125733|"     Zenker's Diverticulum (ZD) is a sac-like outpouching of the lining of the esophageal wall at     the upper esophagus. It is a rare disease typically seen in the middle-aged and older adults.     Common symptoms of the disease include difficulties in swallowing (dysphagia), food reflux     (regurgitation), unpleasant breath smells (halitosis) and couch, choking and hoarseness etc.     (respiratory complications). Pills lodging in the sac and thus unable to take effect is also     a common and yet often overlooked problem.      Traditional treatment for ZD included open resection done by head and neck surgeons and     direct septum division done by ENT doctors. Septum division done by endoscopists is a new     modality of treatment and so far has used the same approach as the ENT doctors-the wall     between the sac and the normal esophageal lumen (the septum) is cut down directly so that     food will not be held in the sac.      A cutting-edge endoscopic treatment for ZD is now emerging. In this approach, what we call     submucosal tunneling endoscopic septum division (STESD), the wall is not cut directly, but     inside a tunnel created by lifting the wallpaper (the mucosa lining the esophageal wall).     After the muscle septum is completely cut, the mucosa is then sealed by clips, restoring     integrity of the esophageal lining.      The advantage of STESD is twofold. First, the esophageal mucosa will be sealed after the     operation, so that the chance of extravasation of luminal content with its relevant     complications will be smaller. Second, under the protection of the tunnel, the endoscopist     will be able to cut the septum completely down to its bottom, ensuring a more satisfactory     symptom resolution. In short, our hypothesis is that treating Zenker's diverticulum by the     tunneling endoscopic technique should be both safer and more effective than traditional     methods.   "
12227|NCT03125720|"     CRT response will be significantly better using image fusion of SPECT MPI and fluoroscopy     venogram to guide LV lead placement at the latest activation segment without scar than     standard-of-care implantation.   "
12258|NCT03125317|"     Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous     cannulation pain and anxiety   "
14396|NCT03097016|"     Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg     CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age     (± 15 years), and weight (± 20%) matched control subjects with normal renal function.   "
12228|NCT03125707|"     To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid     neoplasm (according to WHO 2008 classification) in participating centers      To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and     buccal swap, skin biopsy samples in exceptional cases)      To perform morphologic and genetic analyses      To assess clinical characteristics and outcome data using a defined catalogue containing     clinically relevant variables      To assess biological disease features and correlate with clinical outcome data (prognostic     and predictive markers)      To assess quality of life   "
12229|NCT03125694|"     This study has been designed to investigate the comparative effects of sitagliptin vs.     pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on     the full-dose of metformin and sulfonylurea   "
12230|NCT03125681|"     The purpose of this study is to evaluate the effects of remote ischemic conditioning on     platelet function during off-pump coronary artery bypass surgery.   "
12231|NCT03125668|"     The purpose of this study is to test an educational program with telephone follow-up to     improve health-related quality of life (HRQoL), treatment adherence, and reduce anxiety and     depression symptoms in patients who are starting oral anticoagulants (OA).   "
12232|NCT03125655|"     Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory     changes in the skin. An extensive cytokine network including generated by activated dendritic     cells and T cells mediates the formation of psoriatic lesions. These immune-response     parameters can be used as markers in the severity and management of the disease after further     in-depth studies.   "
12233|NCT03125642|"     This is a phase II study of autologous transplant for patients with Hodgkin (HL) and     non-Hodgkin lymphomas (NHL) including those who are HIV positive.   "
12234|NCT03125629|"     This clinical trial studies how well positron emission tomography (PET)/computed tomography     (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with     cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of     cancer and other types of cancers.   "
12235|NCT03125616|"     In the UK, babies receive their vaccinations according to a standard schedule, irrespective     of their gestation at birth. This policy is designed so that all babies are protected as     early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus,     rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease     and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK     schedule in September 2015 and there has been no research looking at whether the vaccine     gives the same protection to babies born early as it does to those born at term. The     Investigators want to compare two different schedules of 4CMenB and see if one gives better     protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three     doses in early infancy instead of two) will offer better protection for premature babies.     This is what the Investigators are trying to find out through this study.   "
12236|NCT03125603|"     The immune-related adverse events (irAEs) linked to the important activation of the immune     system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma     (NSCLC) have not received a lot of systematic study or been monitored over time outside of     clinical trials.      This study aims to verify, on the basis of the data collected in a prospective and     retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments     observed in the target population of the controlled clinical trials are the same as in the     general clinical population.   "
12237|NCT03125590|"     The PEQ is the first tool to measure facilitators, barriers, and preferences to exercise in     people with osteoporosis.   "
12238|NCT03125577|"     The study will evaluate safety and efficacy of a combination of 4th generation chimeric     antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22     (4SCAR22), CD38 (4SCAR38) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical     response and development of a standardized lentiviral vector and cell production protocol     will be investigated. This is a phase I/II trial enrolling patients from multiple clinical     centers.   "
12239|NCT03125564|"     Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal     tract affecting up to 20 percent of the adolescent and adult populations (1). It is     characterised by abdominal pain, irregular bowel habits, altered stool consistencies and     bloating (2), and is associated with impaired quality of life. IBS can be categorised into     diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type     (IBS-M). Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy     donors to affected subjects has shown impressive results with high cure rates in patients     with recurrent clostridium difficile infections (10). In a small retrospective study using     FMT to treat 13 IBS patients, 70% of patients had symptomatic improvement particularly those     with abdominal pain, dyspepsia, bloating and flatus. Nearly half of the patients achieved     improvement in overall well-being. The investigators propose a randomised, placebo-controlled     trial of FMT in patients with IBS. The investigators will assess the fecal and mucosal     microbiota before and after FMT. Patients will be randomized to either FMT or placebo over a     12 weeks period.   "
12240|NCT03125551|"     Dietary Supplements can affect platelet activation and aggregation, which could result in     bleeding tendencies. This study wishes to evaluate the influence that these supplements has     on platelet function using Rotational thromboelastometry.   "
12241|NCT03125538|"     Motor imagery practice (MIP), which is the repeated internal representation of a movement     without engaging its physical execution and which shares a neurofunctional equivalence with     physical practice, has been show to contribute to promote motor recovery and pain     alleviation. Despite the extensive body of evidence concerning MIP therapeutic effects, the     impact of mental training during lower-limb amputees' rehabilitation process remains to be     investigated. This study was designed to assess MIP effects on the relearning of walking and     the frequency and intensity of phantom-limb pain among acute lower-limb amputees. Data should     contribute to scale up the tools made available to therapists and extend the scope of MIP     application. Moreover, results may contribute to directly provide patients recovering from a     lower-limb amputation with a cost-effective and adaptable technique that could considerably     improve their quality of life.   "
34449|NCT02834871|"     The purpose of this study is to compare the cervical muscular force control , taking into     account the proprioceptive signals, in patients with and without cervical dystonia.   "
12242|NCT03125525|"     Migraine is included in the top-ten disabling diseases and conditions among the Western     populations. Non-invasive neurostimulation (t-SMS), including the Cefaly® device, for the     treatment of various types of pain is a relatively new field of interest. The aim of the     present study was to explore the clinical experience with Cefaly® in a cohort of migraine     patients previously refractory or non-tolerant to topiramate prophylaxis.      Patients were followed prospectively after having been diagnosed with episodic or chronic     migraine with a previous failure to topiramate treatment and having consented to receive     preventive treatment with Cefaly® according to their treating physician's suggestion. A     1-month period of baseline observation was followed by a 3-month period of active treatment     with transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only     preventive treatment.   "
12243|NCT03125512|"     This is a crossover randomized controlled trial comparing a convenient positional therapy     (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional     obstructive sleep apnea (OSA).   "
12244|NCT03125499|"     To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus     placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.   "
12245|NCT03125486|"     GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the     subcutaneous formulation of belimumab which is currently under review by the Food and Drug     Administration (FDA). The goal of this individual patient compassionate use supply is to     provide a patient with subcutaneous belimumab for the period of 1 year or until the     subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially     available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate     via http://www.gsk.com/media/3368/compassionate-use.pdf.   "
12246|NCT03125473|"     A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different     dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1     VP1 and dsRNA adjuvant administered orally to healthy volunteers   "
12247|NCT03125460|"     The objective of this study is to establish the performance characteristics of an assay that     detects the recurrence of bladder cancer in patients previously diagnosed with bladder     cancer. The study is conducted at locations within and outside of the United States. Testing     is performed on urine specimens provided by eligible enrolled patients. Results from this     study will not be used for patient management decisions.   "
12248|NCT03125447|"     Attention functions have a major impact on children's social and school behavior. They are an     important issue for prematurely born children often seen as having learning difficulties and     being restless, when it could be an adaptative answer to attention disorders. The aim of this     study is to evaluate attention capacity in former premature children aged 6-7 years old with     regards to different postures or mobility, for the attention functions of orienting, alerting     and executive control. The Attention Network Test using reaction time and accuracy to visual     stimuli will be used to evaluate attention functions in each posture and mobility.   "
12249|NCT03125434|"     This study aims to describe normal spinal musculoskeletal patterns in healthy adolescents and     young adults by using static and dynamic measures. Static informations are obtained from     full-spine stereoradiography for skeletal measures and from high-resolution spine muscle MRI     for muscular data. Dynamics stability is calculated from 3D gait analysis.   "
12250|NCT03125421|"     A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory     Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.   "
12251|NCT03125408|"     The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in     the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of     the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in     the intended use population.   "
12252|NCT03125395|"     A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With     Cystic Fibrosis, Homozygous for F508del   "
12254|NCT03125369|"     Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial     percentage of the general population. While pharmacotherapy remains the mainstay of     treatment, around 60% of patients cannot achieve the recommended goals for diabetic control.     Weight control is a well-known essential component in normalizing blood glucose level in     T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted     as a valid option for obese T2DM patients with poor glycemic control despite optimal medical     therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard     bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently,     a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy     (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a     knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we     propose to investigate and compare the efficacy of glycemic control and functional outcomes     of SLDJB-SG with conventional RYGBP.   "
12255|NCT03125356|"     The purpose of this study is to determine whether eight weeks of low-calorie sweetener (LCS)     exposure exerts cardiovascular and/or metabolic effects among LCS-naïve overweight and obese     adolescents and young adults. We will examine changes in gene expression in subcutaneous fat     and will correlate these molecular changes with plasma biochemistry.   "
12256|NCT03125343|"     A national cohort study with all patients scheduled for neoadjuvant treatment with     (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal     cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and     patients that have been offered short course raditotherapy with delayed surgery due to     various reasons). The tumours are positioned midrectal or low and are palpable with the     finger. The patients offered this treatment after recommendations on their local     multidisciplinary tumour board will be will be informed and offered to participate in the     study. Patients scheduled for short course radiotherapy with immediate surgery cannot be     included.   "
12257|NCT03125330|"     This research study is designed to answer the question: How does professional coaching impact     early career academic emergency medicine physician goal attainment, leadership strengths,     well-being, and burnout?   "
12259|NCT03125304|"     This proposed trial is a multicenter,randomized and controlled clinical trial. The aim of     this trial is to evaluate the efficacy and safety of acupuncture for treating pain of     Endometriosis.The trial period will consist of three menstrual cycles of treatment, and three     menstrual cycles in the follow-up period.We put forward the following hypothesis: the effect     of acupuncture group is better than the control group on relieving pain.   "
12260|NCT03125291|"     This project is a hybrid efficacy/effectiveness trial of a streamlined version of the Bridges     program, an evidence-based intervention (EBI) to prevent substance abuse and mental health     disorders. Bridges is an integrated parent-youth intervention evaluated in a randomized     controlled trial (RCT) with Mexican Americans (immigrant and U.S. born) that showed long-term     effects on multiple outcomes: substance use initiation and escalation, externalizing and     internalizing symptoms, deviant peer association, and grade point average (GPA) in early     adolescence; alcohol abuse disorder, binge drinking, marijuana use, risky sexual behavior,     diagnosed mental disorder, and school dropout in late adolescence. Building on evidence of     core intervention components and strategies for redesigning EBIs for the real-world,     investigators will partner with low-income, multiethnic schools to adapt the program to a     brief, 4-session format (Bridges short program, BSP), and optimize engagement, delivery,     training, and implementation monitoring systems to facilitate dissemination and     sustainability. The proposed RCT will also examine whether a parent-youth EBI can impact     multiple channels of youth self-regulation (e.g., biological, behavioral, emotional) during     adolescence when neurobiological systems are changing rapidly, and whether preexisting     individual differences in self-regulation moderate program effects.   "
12261|NCT03125278|"     This is a study to compare patient knowledge about the indications of their medications     between two sites. Regions Hospital has a population of patients that receive the medication     indication on the label for any new or changed medications at the time of patient discharge.     Brigham Women's Health follows a standard policy of discharge medication labels including the     name of the medication and instructions for use without any indication of what the medication     is intended to treat. Consented patient will receive a phone call where researchers will ask     about which medications they are taking and other questions about those medications.      The study population will be patients recently discharged from the hospital with 1 or more     new or changed medications   "
12262|NCT03125265|"     The DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated     with HaemoDialysis (DIET-HD) study is a multinational prospective cohort study designed to     evaluate the association between nutrition and dietary patterns and health outcomes in     prevalent adult haemodialysis patients in Europe and South America.   "
12263|NCT03125252|"     The main objective is to evaluate the impact of the bundle of actions on the delirium's     incidence in resuscitation patients during their stay in the service, compared to a     conventional treatment.      The investigators therefore hypothesize that a set of coordinated paramedical actions in the     prevention of delirium would reduce its incidence by 15% compared to conventional care.   "
12264|NCT03125239|"     This research study is studying a combination of two targeted therapies as a possible     treatment for acute myeloid leukemia (AML) that has relapsed after initial treatment or did     not fully respond.      The name of the study interventions involved in this study are:        -  Merestinib        -  LY2874455   "
12265|NCT03125226|"     This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder     tumors in patients undergoing radiation therapy for bladder cancer. TracelT hydrogel marks     the location of a bladder tumor and makes it more visible during imaging tests. Using TracelT     hydrogel tissue marker may help doctors learn more about tumor location and altering     radiation dosage for bladder cancer.   "
12268|NCT03125187|"     The purpose of this phase I study is to know the pharmacodynamic profile in in intravenous     application in humans of the sodium heparin of porcine origin of the company União Química,     building from the pharmacodynamic data generated its pharmacokinetic profile, due to the     dosage limitation of heparin directly in biological samples. In addition, the toxicity of the     product will be evaluated in healthy male participants.   "
12270|NCT03125161|"     To date no prospective trials have been completed that demonstrated whether HAI is an     effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in     conversional resection rates and survival compared with chemotherapy (target therapy) alone.     The primary objective of this trial is to determine conversional resection rates and survival     for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ±     target therapy, compared to chemotherapy ± target therapy only.   "
12271|NCT03125148|"     Malignant duodenal obstruction in patients not fit for surgery is treated by placing enteral     stents during endoscopy. These patients may also have poor gastric motility. Hence bridging     the pyloric opening with the stent along with the duodenal obstruction may deliver better     symptomatic improvement. Both approaches are commonly clinically practiced but no formal     comparative studies have been done to compare which one is better.   "
12297|NCT03121287|"     The purpose of this study is to investigate if cardiac MRI, blood biomarkers, and lung CT     scans can detect early changes to the associated with radiation therapy in patients receiving     radiation treatment for thoracic cancer.   "
12272|NCT03125083|"     The purpose of this study is to determine the role of inflammation in the high prevalence of     psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory     disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the     activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin     pathway). This leads to the development of psychiatric disorders.      Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL     patients according to the presence or absence of psychiatric disorders.      Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin     pathway in patients with a psychiatric disorder.   "
12273|NCT03125070|"     This randomized phase III trial studies health informatics and a self-management program in     improving the health of cancer survivors after stem cell transplant. After transplant many     survivors may feel stressed or may be unsure of what health care they need as a transplant     survivor. A self-management program called INSPIRE, along with a personalized survivorship     care plan may improve stress and health care for transplant survivors.   "
12274|NCT03125057|"     This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy     (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The     population pharmacokinetics of hemoporfin in children will be investigated as well.   "
12275|NCT03125031|"     In this study, the concentration of hemoglobin within the subject's blood will be reduced in     a controlled manner by administering fluids intravenously. The accuracy of two noninvasive     hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a     laboratory analyzer.   "
12276|NCT03125018|"     In this study, the level of oxygen within the blood will be reduced in a controlled manner by     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a     noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation     measurements from a laboratory blood gas analyzer.   "
12277|NCT03125005|"     In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by     administering sodium nitrite intravenously in healthy volunteers. The accuracy of a     noninvasive HbMet sensor will be assessed by comparison to blood measurements from a     laboratory analyzer.   "
12278|NCT03124979|"     In this study, the level of oxygen within the blood will be reduced in a controlled manner by     reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive     pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements     from a laboratory blood gas analyzer.   "
12279|NCT03124966|"     In this study, the concentration of hemoglobin within the subject's blood will be reduced in     a controlled manner by administering fluids intravenously. The accuracy of a noninvasive     hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a     laboratory analyzer.   "
12280|NCT03124927|"     In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by     administering sodium nitrite intravenously in healthy volunteers. The accuracy of a     noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison     to blood measurements from a laboratory analyzer.   "
12281|NCT03124914|"     Fatigue is a common symptom in people living with HIV (PHAs) that affects all aspects of life     . This would include physical deconditioning, a reduction in motor skills . Numerous studies     show that physical activity brings benefits for the quality of life of PHAs . However, due to     the predominantly reported fatigue, many PHAs are not physically active enough in relation to     these recommendations. While it is recognized that fatigue is predominant in PHAs, this     complaint has mainly been subjectively quantified and has rarely been physically objectified     a better understanding of the relationship between neuromuscular fatigue, perceived fatigue     and the level of physical activity of PHAs is needed in line with current work on integrating     fatigue.      OBJECTIVES This project, based on an integrative (eg, neurophysiological and psychological)     approach to fatigue, aims to better explain and prevent the vicious circle of physical     deconditioning in PHAs by examining the relationships between neuromuscular fatigue,     perceived fatigue, Physical activity of patients.      The main objective of the study will be to compare the characteristics of neuromuscular     fatigue in physically active or inactive PHAs.      The secondary objective will be to examine the relationship between neuromuscular fatigue,     level of physical activity and perceived physical fatigue of PHAs.      CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the     patient. Monocentric test to quantify and relate neuromuscular fatigue, perceived physical     fatigue, and physical activity level. The main inclusion criteria for this study are: PLHIV     aged between 40 and 60; Diagnosed and treated with antivirals after 1996, irrespective of the     value of the viral load and CD4 lymphocyte level at the last assessment; The physical     activity level of the patients will be evaluated before the start of the study in order to     constitute two distinct groups        -  Principal evaluation criterion: Investigation of the neurophysiological characteristics          of fatigue will be done by recording the capacity to produce force at the level of the          extensor muscles of the knee under conditions of voluntary contractions and evoked by          magnetic stimulation at the level of Femoral nerve.        -  Secondary evaluation criteria: the investigation of the perceived fatigue will be done          by a valid psychometric questionnaire.   "
12282|NCT03124901|"     In this study, the concentration of hemoglobin within the subject's blood is affected by     fluid status changes. The fluid status is affected by fluid loss during surgery for     hospitalized study subjects or controlled administration of fluids intravenously for healthy     study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by     comparing with blood sample analysis.   "
12283|NCT03124875|"     This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow     Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system     using an endovascular, minimally invasive approach for the treatment of Critical Limb     Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage     procedures.   "
50689|NCT02622100|"     The purpose of this study is to evaluate the relative effectiveness and safety of     Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.   "
12284|NCT03124355|"     The purpose of this study is to investigate how the electrical stimulation of a nerve in the     skin of the earlobe (transcutaneous vagal nerve stimulation), alone or in combination with     two medications (galantamine and pyridostigmine), affects the way the autonomic (involuntary)     nervous system controls heart rhythm, symptoms on standing, and inflammatory markers in     female patients with postural tachycardia syndrome (POTS). The study consists of 2 parts: a     screening (1-2 study days), and 3 testing days. The study will take 5 days total and about 16     participants will be screened for the study. The investigators estimate 13 will be eligible     to participate in all of the study days.   "
12298|NCT03121274|"     Nulliparous women in spontaneous or induced labour with term singleton pregnancy are     randomized into two groups first group (early pushing) in this group patients were allowed to     push within one hour after full cervical dilatation whether the vertex was visible or not.     Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or     start pushing when the vertex was visible.   "
14864|NCT03090906|"     The goal of this study is to compare clinical and histologically the soft tissue changes in     terms of volume gain and stability around dental implants in cases where a subepithelial     connective tissue graft from the palate or from the tuberosity is used randomly   "
12285|NCT03124342|"     Every year, millions of Americans are admitted to the intensive care unit. Due to advances in     critical care, mortality rates are decreasing, increasing the number of ICU survivors.     Survivors of critical illness, however, often face physical, functional, and cognitive     deficits that place them at risk for a cycle of re-hospitalization that frequently culminates     in premature death. Moreover, post-ICU interventions may be resource-intensive and may be     most cost-effective only in a subgroup of patients at highest risk. Whether a     multi-disciplinary program to facilitate recovery from critical illness can prevent hospital     readmission and improve quality of life among high-risk ICU survivors remains unknown. The     primary aim of this pilot is to examine the feasibility of implementing a multidisciplinary     ICU Recovery Program and the influence of such a program on process measures including     contact with the ICU recovery team and attendance of ICU recovery clinic. The secondary aims     are to compare the effect of an ICU Recovery Program on 30-day same-hospital readmission and     other clinical outcomes.   "
12286|NCT03124329|"     Rationale: Treatment of gingival recession defects requires coronal advancement of the     gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth     prognosis, which can be accomplished either through a flap procedure or through a tunnel. It     will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel     Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling.      Another aspect of the study is to determine whether autologous concentrate of platelets and     leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective     tissue autologous graft harvested from the palate.      The overall objective of this study is to evaluate the effectiveness of therapeutic     modalities for the treatment of multiple gingival recession defects.      The study is designed as a prospective, randomized controlled clinical trial. Four groups     will be compared:      Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST)     Group 4: VISTA + L-PRF      Each of the groups will be treated without any graft material in order to examine the     efficacy of coronal advancement and periodontal root coverage without the confounding     variable of graft material. These techniques don't require any additional graft if there is     adequate amount of keratinized gingiva      The study population will be patients who present to Advanced Graduate Program in     Periodontology at the University of Southern California, USA, and are deemed to require     treatment of multiple gingival recession defects. A total sample of 100 participants (23     participants per group) will provide a two sided test of means with 80% power at alpha of     0.05. The calculation was carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC.     Kaysville, Utah.)      The study duration will be 1 year. Follow-up visits after the surgery will occur after 3 days     , 7 days and at weeks 3, 6, 12, 24, 36 and 52. These follow up visits consistent with     standard of care follow up for gingival recession treatment and there will be no additional     costs to the participant.      The Primary Outcome variable is complete root coverage; the Secondary Outcome Variables are     clinical attachment level (CAL) gain, changes in gingival thickness and volume and the     Tertiary Outcomes are aesthetic outcomes, postoperative pain and Patient satisfaction survey   "
12287|NCT03124316|"     Family doctors can play a critical role in successfully arranging cancer screening tests to     occur, especially if they know which patients are due for these tests. However, they don't     always interact with or take advantage of registry data to this end. For example, in Ontario,     the Screening Activity Report provides exactly this information to family doctors, helping     them identify their patients who are overdue for screening. Unfortunately, less than half of     family doctors regularly use the Screening Activity Report even though they get monthly email     reminders. One possible reason is that the reminders they receive are not designed to compel     action. They are easy for family doctors to miss or dismiss. This study will compare multiple     different ways of designing the reminders. The different versions of the email are tested in     a 2^3 factorial trial testing three behaviour change techniques to see which ones will lead     to more family physicians interacting with the Screening Activity Report and at increasing     the number of patients that get all the appropriate screening tests for cervical, breast,     and/or colon cancer.   "
12288|NCT03124303|"     The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and     postoperative delirium in patients undergoing major surgery. This is a expansion of the     NeuroVISION Bolt-On study, NCT01980511.   "
12289|NCT03124290|"     The investigators plan to investigate the effect of attention distractor on the quality of     chest compression during cardiopulmonary resuscitation. For this, a simulated study with     Manikin is performed and the paced auditory serial addition test (PASAT) is used for     distracting performer's attention.   "
12290|NCT03124277|"     This randomized, trial will tested the hypothesis that nutritional supplementation with whey     protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the     efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o     parkinsonism   "
12291|NCT03121365|"     This study evaluates the effects of digital versus standard literacy promotion, as well as     dialogic language behaviors and reading comprehension among infants when comparing the use of     e-books to standard board books. Around half of the participants will receive standard board     books at the 6, 9, and 12 month well visits, while the other half will receive digital     e-books.   "
12292|NCT03121352|"     The purpose of this study is to see how effective the combination of the two chemotherapy     drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab.      Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the     immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental     because it is not approved by the Food and Drug Administration (FDA) for this type of breast     cancer treatment.   "
39580|NCT02767557|"     This is a single center, 2-arms prospective randomized phase II trial which evaluates whether     tocilizumab with gemcitabine/nab-paclitaxel is more effective than     gemcitabine/nab-paclitaxel.   "
12293|NCT03121339|"     This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the     study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral     based influenza vaccine, has an impact on delivery location. The secondary objective is to     evaluate delivery with fasting versus fed status.   "
12294|NCT03121326|"     With the rapid growth of the global elderly population, the studies of the biomarkers of the     sarcopenia and aging are under investigation in different ways. The investigators use     Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.   "
12295|NCT03121313|"     Primary Objective:      To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with     squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes.      Secondary Objectives:        -  To determine the 2-year locoregional failure rate.        -  To evaluate the 2-year overall survival (OS) rate.        -  To evaluate the 2-year progression-free survival (PFS) rate.        -  To assess the safety profiles.   "
12296|NCT03121300|"     Little is known about the safety of body radiation therapy (SBRT), especially the impact on     pulmonary function, quality of life, and on functional changes within the lung itself.     Radiation dose constraints and capturing functional changes on imaging are not well studied     in this setting.      The current study aims to evaluate the utility of advanced imaging to measure lung function     prior to and after treatment and to assess the feasibility of using this data to adapt SBRT     planning.   "
12299|NCT03121261|"     The cutaneous silent period is a non-invasive technique that gives insight into the function     of thin A delta fibers and as such can be a complement to conventional electrophysiological     methods used to study the peripheral nerves. Clonidine is a selective partial agonist of the     alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a     local anesthetic, prolongs sensory and motor block during local anesthesia and extends the     length of post-operative analgesia. It is believed that clonidine achieves this effect by     activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord     and blocking the conduction of A-delta and C fibers. The aim of the study is to examine     functional changes of Aδ - fibers during the application of spinal anesthesia by measuring     the cutaneous slinet period and compare the effect of intrathecal administration of a     combination of local anesthetic and clonidine in the quiet skin period in relation to the     application of local anesthetic only.   "
12300|NCT03124836|"     In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by     administering sodium nitrite intravenously in healthy volunteers. The accuracy of the     noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to     blood measurements from a laboratory analyzer.   "
12301|NCT03124823|"     In this study, the level of oxygen within the blood will be reduced in a controlled manner by     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a     noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation     measurements from a laboratory blood gas analyzer.   "
12302|NCT03124797|"     In this study, the level of oxygen within the blood will be reduced in a controlled manner by     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a     noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation     measurements from a laboratory blood gas analyzer.   "
12303|NCT03124784|"     In this study, the level of oxygen within the blood will be reduced in a controlled manner by     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a     noninvasive pulse oximeter sensor under motion conditions will be assessed by comparison to     the oxygen saturation measurements from a laboratory blood gas analyzer.   "
12304|NCT03124771|"     In this study, the concentration of hemoglobin within the subject's blood will be reduced in     a controlled manner by administering fluids intravenously. The accuracy of a noninvasive     hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a     laboratory analyzer.   "
12305|NCT03124758|"     In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by     comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples     are collected from healthy volunteers who are enrolled in either a blood draw procedure or a     hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin     is reduced in a controlled manner by administering fluids intravenously.   "
12306|NCT03124693|"     In this study, the concentration of hemoglobin within the subject's blood is affected by     fluid status changes. The fluid status is affected by fluid loss during surgery for     hospitalized study subjects or controlled administration of fluids intravenously for healthy     study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by     comparing with blood sample analysis.   "
12307|NCT03124680|"     Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.      For a long time, opioids have been covering the analgesia function. (1) When using opioids,     an analgesic effect is obtained per-operatively, however, not without side-effects.     Post-operative complications such as: respiratory depression, post-operative nausea and     vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus,     are well known.      Opioid usage is an important risk factor of postoperative desaturation. Postoperative     desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious     cardiologic and neurological complications.      Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.      Non-opiate protocols implemented on the obese patient have been published. Non-opiate     protocols have been established using a combination of ketamine, lidocaine and an alpha-2     agonist.      The main purpose of this pilot study is to evaluate whether patients undergoing an opioid     free anaesthesia regime experience less desaturation episodes during the first 24 h     post-bariatric surgery than patients having received an opioid anaesthesia regime.   "
12343|NCT03124056|"     The aims of the study:        1. To evaluate the clinical efficacy of the use of extracorporeal photopheresis in the          treatment of Graft-versus-host disease under standard clinical indications as          pre-defined by the participants Centers (members of the Spanish Group for Hematopoietic          Transplantation).        2. To explore and identify biomarkers of clinical response to extracorporeal photopheresis          treatment of acute or chronic Graft-versus-host disease after Allogeneic hematopoietic          stem cell transplantation   "
12308|NCT03124667|"     The purpose of this double-blinded, randomized controlled study is to compare CORTEX     (Cognitive Regulation Training and Exercise), a multi-faceted, center- and home-delivered—     general and exercise-specific—active and traditional computerized cognitive training (CT)     program to an attention-control condition involving health and wellness informational videos.     More specifically, the cognitive training group will emphasize dual-task abilities, working     memory, and visual-spatial processing, as well as self-as-exerciser priming and     self-certainty training. It is hypothesized that early intervention cognitive training will     enhance use of self-regulatory strategies and self-efficacy and in turn, increase exercise     adherence to and engagement in a 12-month aerobic and resistive exercise program at a local     fitness facility. More positive improvements in cognitive and psychosocial functioning among     participants in the CORTEX condition (relative to the Video Attention-Control condition,     i.e., health educational videos), are also expected immediately following the cognitive     training, and across time. Expectancies and knowledge of study purpose (blinding integrity)     will also be measured and used to statistically adjust for any training differences.   "
12309|NCT03124654|"     Pharmacists are in the best position to counsel and educate patients on anticoagulant agents     such as NOACs. This should enable patients to play a more active role in their treatment and     ultimately enhance adherence behaviour. However, educational elements should be targeted to     knowledge. Thus, the investigators will develop and validate a questionnaire that can assess     knowledge about NOACs   "
12334|NCT03124186|"     This research project addresses a scientifically important question that cannot be answered     by other means. The use of peripheral nerve stimulation has the potential to enhance recovery     in subacute stroke patients with poor functional recovery. The primary objective of this     proposal is to demonstrate that peripheral nerve stimulation combined with intensive motor     training has the ability to further improve hand motor function when compared to intensive     training alone or nerve stimulation alone. The results from this study have the potential to     develop new strategies in neurorehabilitation.   "
12310|NCT03124641|"     The purpose of this study is to test the effects of hypothermic oxygenated machine perfusion     (HOPE) in a phase-II prospective multicenter randomized clinical trial (RCT) on extended     criteria donor allografts (ECD) in donation after brain death (DBD) orthotropic     liver-transplantation (OLT) (HOPE-ECD-DBD). Human whole organ liver grafts will be submitted     to 1-2 hours of HOPE via the portal vein directly before implantation and going to be     compared to a control-group of patients transplanted after conventional cold storage (CCS).     Primary (early graft injury) and secondary (e.g. postoperative complications, hospital stay,     survival) objectives are going to be analysed in a 12 month follow up. Ischemia-reperfusion     (I/R) injury and inflammation will be assessed using liver tissue, serum and bile samples as     well as machine perfusion perfusate.      To improve the availability of donor allografts and reduce waiting list mortality, graft     acceptance criteria were extended increasingly over the decades. The use of extended criteria     donor (ECD) allografts is associated with higher incidences of primary graft non-function     (PNF) and/or delayed graft function (DGF). As such, several strategies have been developed     aiming at reconditioning poor quality ECD grafts. HOPE has been tested intensively in     pre-clinical animal experiments. Although, its known that HOPE can exert its reconditioning     effect via cellular and mitochondrial pathways in the endothelial and parenchymal cells,     there is still scarce evidence available on the exact subcellular mechanism of HOPE induced     organ protection in the clinical scenario of liver transplantation. In donation after cardiac     death (DCD) OLT, the positive effects of HOPE have been shown to reduce the incidence of     biliary complications, mitochondrial damage and improve the overall cellular energy-status.      In the HOPE setting, organ perfusion is performed in the transplant center shortly before the     actual implantation with oxygenated perfusate using an extra corporal organ perfusion system.     The first clinical study with this promising technique was recently reported in a Swiss     cohort of patients who received DCD allografts. In organ donation after brain death (DBD),     the only legally accepted approach for organ donation in most countries, HOPE and its effect     on early graft injury and postoperative complications remains to be elucidated.   "
12311|NCT03124628|"     The main purpose of this project is to improve physical function and muscle health in     teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance     exercise model      Specific aims        1. To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in          inducing muscle, functional and gait performance adaptations in teenagers with CP.        2. To increase force, power and muscle mass in the lower limbs of patients with cerebral          palsy.        3. To improve gross motor function, balance and gait through eccentric-overload resistance          exercise in teenagers suffering from cerebral palsy.      We hypothesize that the time-effective flywheel resistance exercise paradigm will result in     greater gains in muscle mass and function in teenagers with CP, when compared with     conventional weight-stack technology. Importantly, we believe these adaptations will be     translated into enhanced gross motor function, balance and gait performance.      Forty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They     will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance     exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise     training program within the Stockholm Habilitation Center system. In addition, patients will     perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise     twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag,     co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of     lower extremities are assessed in all patients before and after the 8-week intervention (Fig.     1).   "
12312|NCT03124615|"     The primary purpose of this trial is to determine whether dose reduction of enzalutamide in     patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms     while maintaining active drug levels.      Patients within 3 months of starting enzalutamide will be assessed by their oncologist as     being potentially eligible for dose reduction due to the onset of moderate to severe fatigue     and/or cognition change, which is assessed as being due to enzalutamide   "
12324|NCT03124446|"     Mindfulness interventions are increasingly offered to undergraduate students at universities     world-wide, however the evidence base is very limited. The objective is to evaluate effects     of a customized mindfulness intervention (called Mindfulness-Based College) on undergraduate     student health. A superiority randomized controlled trial with parallel groups will be     performed with 30 participants in each arm. Participants will be randomly assigned to     Mindfulness-Based College or health education waitlist control. Investigators will be blinded     to treatment allocation. Participants will be assessed at baseline, 10 weeks, and six months.     The primary outcome is a college health summary score, including seven evidence-based     determinants of health particularly relevant to college student well-being: body mass index,     physical activity, diet, alcohol consumption, sleep quantity, perceived stress, and     loneliness. Primary intention-to-treat analyses will evaluate whether MB-College vs. control     is associated with the summary score, utilizing generalized linear models. Secondary analyses     will evaluate which, if any, of the seven determinants of health are driving associations.   "
12313|NCT03124589|"     Online interventions for gambling problems hold a strong potential to help people with     gambling concerns. However, there are no trials, to-date, that have been able to demonstrate     the effectiveness of such an intervention. The current trial will compare participants     provided access to an online gambling intervention to those assigned by chance to a no     intervention condition in order to test the efficacy of one such Internet intervention for     gambling.      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential     participants identified as problem gamblers who are interested in quitting or reducing their     gambling in the next 6 months, or often think about it, based on an initial survey will be     invited to complete additional surveys at 6 weeks and 6 months. Those who then agree to be     followed up will be randomized to access an online intervention for gambling or a     no-intervention website. These participants will then be contacted again at 6 weeks and 6     months to ask about their gambling, and their impressions of the online intervention. The     primary hypothesis to be tested is that participants receiving access to the online gambling     intervention will report a greater reduction in number of days gambling and in NODS scores at     6-month follow-up than participants in the no intervention control condition.   "
12314|NCT03124576|"     In the proposed study the investigators aim to clarify the relative contribution of these     different mechanisms to the progression of AF. Also the contribution of the individual     genetic background will be investigated. Furthermore, the investigators aim to identify     clinical parameters and biomarkers informing on the main mechanisms of AF progression in     atrial tissue.      For this purpose, in all included patients atrial biopsies will be taken during cardiac     surgery.   "
12315|NCT03124563|"     The study goal is to design an intervention utilizing implementation intentions to help     participants prospectively plan and visualize ways to increase activity for the next day     among working adults who do not currently exercise or use an activity monitor. Investigators     will assess the level of and changes in physical activity, and how this relates to various     individual factors that are related to exercise and health, including self-efficacy, control     beliefs, and cognition.   "
12316|NCT03124550|"     The study goal is to design and build an exergame to increase physical activity and social     connections for Alzheimer's Disease (AD) caregivers using participatory design methods. AD     caregivers will contribute extensively to the design and development of the content and     motivational components of the exergame. The investigators will evaluate user experience with     the exergame and the feasibility of using it to increase physical activity, exercise     self-efficacy, and social connections among AD caregivers.   "
12317|NCT03124537|"     The goal of this study is to develop a smart phone/tablet app to administer a behavior change     program that helps adults to increase daily steps by planning where, when, and with whom to     walk. The investigators will test the effectiveness of various components of the walking     program app for increasing the number of daily steps among sedentary older adults. The     investigators also will examine the effects on self-efficacy and social integration/support.   "
12318|NCT03124524|"     Our aim is to evaluate and compare the pain relief of estradiol valerate/dienogest and     ethinylestradiol/ drospirenone by using doppler indices.      100 nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting     contraception aged from 18 to 35 were included to the study. Visual analog scale (VAS), the     uterine artery doppler indices including systole/diastole rates ( S/D), pulsatility index     (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels     before treatment. The 66 PD patients who met the inclusion criteria were divided into 2     groups and 33 healthy controls created Group 1. Group 2 were administered estradiol     valerate/dienogest while Group 3 were administered 0.03 mg ethinylestradiol and 3 mg     drospirenone. Both VAS scores and doppler indices were repeated after 3 months treatment. The     changes in values were recorded.   "
12319|NCT03124511|"     To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging     from molecular pathways to societal impacts.   "
12320|NCT03124498|"     A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous     Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after     Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or     RadioFrequency Ablation (RFA) Therapy.   "
12321|NCT03124485|"     Obesity and its related metabolic disorders are increasingly a heavy health burden to many     parts of the world. Weight control is a well-known important step in avoiding type 2 diabetes     mellitus (T2DM). It is also an essential component for normalizing the blood glucose and     preventing macrovascular and microvascular insults to patients with diagnosed T2DM. However,     life-style modification, physical exercise and dietary adjustment are ineffective measures     which are unlikely to confer adequate and sustainable weight loss for the truly obese. On the     other hand, large scale long-term follow-up studies have confirmed the role of bariatric     surgery in providing durable weight loss and remarkable improvement on medical comorbidities.     Among all the bariatric operations, laparoscopic sleeve gastrectomy (LSG) is currently the     most widely adopted procedure worldwide because of its simplicity and effectiveness in weight     reduction. However, LSG is not without risk. Staple-line hemorrhage, leakage and stenosis are     potentially life-threatening complications. LSG is also costly because of the need for     expensive laparoscopic staplers.   "
12322|NCT03124472|"     Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.        -  The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the          urinary bladder and expose the lower uterine segment.        -  Uterine artery ligation was performed by grasping the broad ligament with thumb anterior          and the index finger lifting the base below the site uterine incision; the uterine          artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that          uterine vessels are not damaged.        -  Cresenteric lower uterine segment incision was performed as usual. Higher incisions were          performed in cases where the traditional incision was expected to be directly through          the placenta Delivery of the baby and placenta.        -  Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.        -  Closure of the anterior abdominal wall in layers   "
12344|NCT03124043|"     The objective of the Get In Touch - Phase 2 (GIT-2) study was to evaluate a diabetes care     support intervention facilitated by cellular-enabled glucose meters in adults with persistent     poor control of type 2 diabetes.   "
12325|NCT03124433|"     This is an investigator-initiated phase II single arm trial, combining neoadjuvant     apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to     high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate     resistant prostate cancer in phase II studies and are now in phase III trials combined with     radiation in organ confined disease.      The primary study objectives include assessment of (i) oncological efficacy as determined by     tumour downstaging and achievement of nadir PSA The secondary study objectives include(i)     determination of adverse effects related to apalutamide and surgical complication rates (ii)     human prostate tissue effect of apalutamide      The study will recruit thirty eligible participants who will receive 12 weeks of oral     apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The     total trial duration is 26 weeks.   "
12335|NCT03124173|"     The cognitive control of speech is central to human social communication. Two frontal brain     regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex     (MCC). Current rehabilitation strategy is clearly based on therapies promoting language     performance. However, there is few evidence that rehabilitation strategies based on     nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit     from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of     LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking     primates, this network is involved in cognitive control of voluntary vocal/orofacial     production. Specifically, whereas BA may be responsible for the high-level selection of     orofacial and vocal responses during learning, the face motor representation within the MCC     may be responsible for performance monitoring, a process inherently required in learning.     LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional     organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).   "
12326|NCT03124420|"     Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans.      The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated     that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown     that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease,     gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a     Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above     diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces     the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication     rate of clarithromycin-based triple therapy has been declining in recent years, probably     related to the increasing resistant rate to clarithromycin. Several strategies have been     proposed to overcome the declining eradication rate, including (1) extending the treatment     duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which     contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and     tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a     proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and     clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus     amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another     five days. The investigators aim to improve the eradication rate of H. pylori infection while     an endoscopic examination is performed.   "
12327|NCT03124407|"     This is a study of a OTC TFM compliant, capsaicin-based (0.25%) topical analgesic for     management of osteoarthritis (OA) knee pain (OAKP). Subjects meeting the inclusion criteria     and not meeting the exclusion criteria will be randomized into one of four groups: once daily     treatment with active product, once daily treatment with product vehicle (no capsaicin),     twice daily treatment with active product, and twice daily treatment with product vehicle (no     capsaicin), all for 7 consecutive days of treatment. The twice daily treatments are spaced     approximately 12 hrs apart. OAKP is assessed by the 100 mm VAS scale. OAKP assessments are     done each day for 28 days. Tolerability data are also collected.   "
12328|NCT03124394|"     Evaluation of clinical outcome and economical aspects in the treatment of patients with     peritoneal carcinomatosis.   "
12329|NCT03124368|"     The purpose of this study is to determine the effect of ACH-0144471 on C3 levels in patients     with C3G or IC-MPGN.   "
12330|NCT03124238|"     The main objective of the current proposal is to investigate the clinical and physiological     changes triggered by massage therapy in a group of individuals with chronic low back pain     experiencing muscular fatigue.      The investigators believe these objectives are in line with the 2014 Massage Therapy     Research Fund research priorities, since the results produced by these investigations will     generate knowledge with regard to the short term clinical efficacy of massage therapy and     will provide critical information related to the physiological mechanisms underlying massage     therapy clinical effects. Most importantly, the combined assessment of clinical and     physiological outcomes will also yield key information to identify specific biological     components of the massage therapy intervention. Determining the presence of a biological     mechanism is, as for any treatment, considered one of the necessary criteria to declare a     causal relationship between a specific intervention and its associated clinical effects. The     investigators strongly believe that the proposed research will contribute to the     identification of specific mechanisms that will complement the emerging clinical evidence     supporting massage therapy in the treatment of chronic low back pain.      The proposed research project will involve researchers and future practitioners of massage     therapy. In conjunction with a high quality research environment, it is the goal of the     investigators to create an educational environment for undergraduate and graduate students     that will foster interdisciplinary collaboration in order to ensure a diversified; high     quality training of young researchers and clinician scientists working in the field of manual     therapies.   "
12331|NCT03124225|"     The aim of this research study is to describe the impact of rheumatologist performed     ultrasound on the diagnosis and management pathways of patients with rheumatoid arthritis.     Primarily, to compare the time from first visit to treatment initiation between patients with     and without rheumatologist-performed ultrasound assessment.   "
12345|NCT03124030|"     Direct Oral Anticoagulants were recently approved for medical treatment of several condition     such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting     sometimes the conventional oral anticoagulants. The aim of the present study is to observe     the possible difference in intra-operative and post-operative bleeding events for single     dental extraction.   "
12332|NCT03124212|"     Breast, colorectal, ovarian, and endometrial cancers constitute approximately 30% of newly     diagnosed cancer cases in Switzerland and affect more than 12,000 individuals annually.     Several hundred of these patients are likely to carry known genetic mutations associated with     HBOC or LS. Genetic testing for hereditary susceptibility to cancer can prevent many cancer     deaths through early identification and engagement in high-risk management care that involves     intensive surveillance, chemoprevention and/or prophylactic surgery. However, current rates     of genetic testing indicate that many Swiss mutation carriers and their family members do not     use cancer genetic services (counseling and/or testing), either due to lack of coordination     of care or due to lack of communication about the mutation among family members.      Cascade screening identifies and tests family members of a known mutation carrier. It     determines whether asymptomatic family members are carriers of the identified mutation and     proposes management options to reduce harmful outcomes. Robust evidence of basic science and     descriptive population-based studies in Switzerland support the necessity of cascade     screening for HBOC and LS. However, translation of this knowledge into public health     interventions is lacking.      Specific Aims of the CASCADE study are:        1. Survey Index Patients diagnosed with HBOC or LS from clinic-based genetic testing          records and determine their cancer status and surveillance practices; needs for          coordination of medical care; psychosocial needs; patient-provider and patient-family          communication needs; quality of life; willingness to serve as advocates for cancer          genetic services for blood relatives.        2. Survey first- and second-degree relatives, and first cousins identified from pedigrees          and/or family history records of HBOC and LS Index Patients and determine their cancer          and mutation status; cancer surveillance practices; needs for coordination of medical          care; barriers and facilitators to using cancer genetic services; psychosocial needs;          patient-provider and patient-family communication needs; quality of life; willingness to          participate in a study designed to increase use of cancer genetic services.        3. Explore the influence of patient-provider communication about genetic cancer risk on          patient-family communication and the acceptability of a family-based communication,          coping, and decision support intervention with focus group(s) of mutation carriers and          blood relatives.   "
12333|NCT03124199|"     Background: A progressive decrease in Helicobacter pylori eradication rates has been     described over the years, so new combinations of antibiotics for treatment are needed.      Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple     therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori.      Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty     consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and     naive to eradication treatment. A full blood test was performed in the first 5 patients     included to evaluate the safety of the treatment. H. pylori eradication was confirmed with     urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8     h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.   "
34494|NCT02834286|"     The purpose of this study is to determine the response rate and response duration with the     combination of low-dose rituximab, eltrombopag and high-dose dexamethasone.   "
12337|NCT03124147|"     This study will compare the effectiveness of different polarities of transcranial direct     current stimulation paired with intensive motor training in recovery of upper extremity     function in individuals with severe post-stroke hemiparesis. The hypothesis is that more     severely impaired individuals will derive greater benefit from anodal stimulation of the     ipsilesional hemisphere or cathodal stimulation of the contralesional hemisphere than dual     stimulation (anodal applied to the ipsilesional hemisphere and cathodal applied to the     contralesional hemisphere.)   "
12338|NCT03124134|"     A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and     without Gelesis200.   "
12339|NCT03124121|"     The purpose of this study is to gain insight into the exposure-response relationship of     golimumab in moderate-to-severe Ulcerative Colitis (UC).      Patients commencing induction therapy with golimumab will be enrolled into a prospective     study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC     disease activity as well as serum golimumab concentrations and the presence of anti-golimumab     antibodies. Patients already established on stable golimumab maintenance therapy will be     enrolled into a cross-sectional study with the same evaluations taken at a single time point.   "
12340|NCT03124108|"     The primary objective of the study is to compare the effect of daily oral administration of     elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo     in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).   "
12341|NCT03124095|"     The aim of the present study is analyze the effects of combined training program (resistance     and aerobics) in comparison with a non-training group on quality of life, as well as on     neuromuscular and cardiorespiratory parameters in breast cancer patients in stages one to     three who have finished their treatment, such as surgery, chemotherapy and radiotherapy.     Therefore, 42 women will be randomly divided into two groups: combined training group and     control group. The subjects of the combined training group will undergo the intervention     three times a week for eight weeks. The combined group will carry out both resistance and     aerobic exercises in the same session. The resistance training will be comprised by ten     exercises which will alternate body segments with maximum repetitions in the first set and     the lower limit of the repetitions interval in the next sets. Along the training, the number     of series will be increased whereas the number of repetitions will be decreased. The     intensity of the aerobic exercises will be based on the percentage of the heart rate of the     anaerobic threshold on the first weeks and on the speed of the anaerobic and aerobic     threshold on the last weeks. Before and after the intervention, there will be evaluation of     maximal dynamic strength of knee extensors and elbow flexors, maximum voluntary isometric     contraction of knee extensors, maximum muscular activity of vastus lateralis and rectus     femoris, muscle thickness of knee extensors, peak oxygen uptake and ventilatory threshold,     quality of life and cancer-related fatigue. Data will be analyzed by Generalized Estimating     Equations (GEE) and Bonferroni's post-hoc (α=0,05), including both protocol and intention to     treat.   "
12342|NCT03124082|"     Opioids have been used for analgesia since many years, but despite potent analgesia they are     also associated to side effects, including opioid induced Hyperalgesia (OIH).      OIH in the surgical setting is debated, and may predispose patients to higher analgesic     consumption in the preoperative period, and peripheral and central sensitization. The aim of     the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine,     ketamine) for intraoperative management of patients undergoing laparoscopic left     hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine     consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be     tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System)     sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered,     together with any side effect and parameters of surgical rehabilitation.   "
12346|NCT03124017|"     The investigators aim to investigate whether a computer-based alert system in the electronic     patient chart and order entry system using the Geneva Risk Score as clinical decision support     tool to estimate the risk of venous thromboembolism improves the rate of appropriate     thromboprophylaxis among hospitalized medical patients.   "
12347|NCT03124004|"     Direct Oral Anticoagulants were recently approved for medical treatment of several condition     such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting     sometimes the conventional oral anticoagulants. The aim of the present study is to observe     the possible difference in intra-operative and post-operative bleeding events for periodontal     debridement.   "
12348|NCT03123991|"     The current study proposes to extend transdiagnostic treatment research to adolescents by     establishing initial pre to post-treatment and follow-up outcomes associated with the use of     the Spanish Version of the Unified Protocol for the Treatment of Emotional Disorders in     Adolescents (UP-A; Ehrenreich-May, Bilek, Buzzella, Kennedy, Mash, & Bennett, 2016) as a     universal school-based preventive intervention.   "
12371|NCT03123692|"     A pilot study to explore safety of the treatment with the antioxidant and metal chelator NBMI     in COPD patients.      Investigational product: NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide), INN: Emeramide      Indication: Mild, moderate and severe COPD with bronchitis      A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days     pilot study in subjects with COPD with bronchitis.   "
12349|NCT03123978|"     This phase I trial studies the best dose and side effects of niclosamide when given together     with enzalutamide in treating patients with castration-resistant prostate cancer that has     come back or has spread to other places in the body. Androgens can cause the growth of     prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by     lowering the amount of androgen the body makes and/or blocking the use of androgen by the     tumor cells. Niclosamide may block signals that enhance prostate cancer cell growth. Giving     enzalutamide and niclosamide may work better in treating patients with castration-resistant     prostate cancer.   "
12350|NCT03123965|"     This is an expanded access program (EAP) for eligible participants. This program is designed     to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory     agency. Availability will depend on territory eligibility. Participating sites will be added     as they apply for and are approved for the EAP. A medical doctor must decide whether the     potential benefit outweighs the risk of receiving an investigational therapy based on the     individual patient's medical history and program eligibility criteria.   "
12351|NCT03123952|"     This is an expanded access program (EAP) for eligible participants. This program is designed     to provide access to ABT-414 prior to approval by the local regulatory agency. Availability     will depend on territory eligibility. Participating sites will be added as they apply for and     are approved for the EAP. A medical doctor must decide whether the potential benefit     outweighs the risk of receiving an investigational therapy based on the individual patient's     medical history and program eligibility criteria.   "
12352|NCT03123939|"     This is a single arm, open-label, multi-center, phase II study to determine the safety and     efficacy of CTL019 in pediatric/young adult patients with r/r B-cell ALL.   "
12353|NCT03123926|"     The prediction of preterm birth is beneficial because it initiates early treatment to     minimize risk. It defines a population at risk to provide particular treatment and may lead     us to a better understanding the mechanisms of preterm birth. The understanding of the     mechanisms and etiology consequently leads to the possibility of early intervention and     effective management aiming at preventing preterm birth. Five most common interventions for     preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest,     progesterone, and tocolytic therapy. However, there are insufficient evidence showing the     efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm     birth; the use of certain tocolytics needs to be considered against the possible adverse     effects. The early detection of pregnant women with high risk for preterm delivery would be     the ideal solution to prevent preterm birth. However, to date, there is inadequate literature     and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.   "
12354|NCT03123913|"     The purpose of this study is to investigate the safety and tolerability of combination     therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients     with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.   "
12355|NCT03123900|"     The MoveMent project applies non-pharmacological strategies - physical exercise and cognitive     training - that have been shown to be effective in promoting active and healthy aging. The     objective is to study the molecular and neural mechanisms of these strategies to stimulate     brain plasticity and improve brain health and cognitive functioning.   "
12356|NCT03123887|"     Although the response rate by first-line treatment has been improved, most adult patients     with relapsed or refractory ALL will eventually relapse with poor outcomes regardless of     treatments. To further understand current status of the treatment of adult patients with     relapsed or refractory ALL in China, the study retrospectively collected diagnosis and     treatment data from ALL patients in 14 centers in China. Primary objective: to estimate the     proportion of patients in overall response rate (ORR) for early relapsed or primary     refractory Philadelphia chromosome negative (Ph-) B-precursor ALL patients following salvage     treatment (i.e., proportion of patients in hematological complete remission [CR] and CR with     partial recovery of blood cells [CRh*]); Secondary objectives included: to estimate the     proportion of patients in CR, CRh* and CRi(CR/CRh*/CRi) and the duration of CR/CRh*/CRi,     overall survival, duration of CR/CRh*and the proportion of patients receiving allogeneic     hematopoietic stem cell transplantation (AlloHSCT) for early relapsed/primary refractory     Ph-B-precursor ALL patients following salvage treatment; Exploratory objectives included: to     estimate the efficacy in late relapsed Ph- B-precursor ALL (first remission duration > 12     months) patients and in Ph+ B-precursor ALL patients and specific subgroup patients following     salvage treatment.   "
12357|NCT03123874|"     The MiLC trial is a randomized control trial of two different types of breast pumps--mother's     own and sterile. The objective of this trial is to investigate the bacterial composition of     human milk pumped and stored in real-life conditions. To meet this objective, lactating     mothers will fully express breast milk from one breast on two consecutive pumping sessions at     home, once with the participant's own pumps and bottles and once with a sterile,     hospital-grade pump and sterile bottles. Randomization will be used to determine which pump     participants use first. From the total volume of milk pumped during each pumping session, the     researchers will collect 1 oz. Milk from both pumps will be stored at home and sampled on     days 0, 2, 4, and 30 after expression for analysis of its bacterial composition.   "
12358|NCT03123861|"     Purpose: To assess the impact of gabapentin versus placebo on overall postoperative pain and     gluteal pain at 1 week post vaginal sacrospinous ligament suspension for apical pelvic organ     prolapse.      Participants: English-speaking women planning to undergo a vaginal SSLF. Concurrent     procedures can be performed except total vaginal hysterectomy, colpocleisis, anal     sphincteroplasty, fistula surgery, or urethral diverticulectomy      Procedures (methods): Patients will be randomized to receive either 2 weeks of gabapentin or     placebo for 2 weeks post-operatively. Standard of care pain medications will be given to both     groups. Patients will be followed for 6 weeks post-operatively.   "
12359|NCT03123848|"     The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir     (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI     fixed-dose combination tablet) in healthy Japanese adult participants.   "
12360|NCT03123835|"     Evaluation of current and newly developed endoluminal therapies in the management of Upper     and Lower GI conditions.   "
36297|NCT02810652|"     The purpose of this research study is to addresses the challenge of managing the unique     perioperative needs of older cancer patients undergoing surgical resection.   "
12361|NCT03123822|"     Recent studies have shown children who sustain a concussion are susceptible to having chronic     symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn     and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are     some of the reported chronic symptoms that can affect patients' daily activities. Concussion     awareness has increased recently and there is a surge of interest to better understand and     treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are     often empirically determined. Common treatments are vision therapy and/or bifocal glasses.     There has yet to be any standardization or prospective studies looking into treatment for     these concussed patients with ocular symptoms and findings. The objective of this protocol is     to compare three different types of glasses (typical prescription glasses for kids, typical     glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare     coating) as treatment options for participants who are still symptomatic four weeks out from     their concussion. The main outcome is the effectiveness of these three different options in     reducing patients' symptoms and improving the participants' visual findings.   "
12362|NCT03123809|"     Gastroparesis (GP) is describing a condition when stomach does not empty as fast as it     should. This fact creates the situation, when food stays in the stomach for a long time and     it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish     normal size meal and abdominal pain. There are not many drugs available to treat this     condition and majority of gastroparetic patients are not responding well to them after they     are on it for some time. Many investigators are able to implant Gastric Stimulator System     (GES) under FDA approved status of Humanitarian Device Exemption (HDE) definition. In the     last few years it became possible to add another surgical procedure, which is called     pyloroplasty (making bigger opening on the end of stomach), may help even more as it is also     increasing the rate of the emptying of the stomach. Therefore this study is proposing to     evaluate if GES in combination with pyloroplasty is much better than pyloroplasty alone. For     this reason, two of these procedures will be introduced surgically at the same time, but GES     devices will not be turn ON in half of these participants for 3 months. After that time all     subjects will have their devices turned ON. All subjects will be asked to evaluate their     symptoms of gastroparesis and their quality of life during clinical visits, and investigators     will conduct pathological analyses of tissue obtained during surgery.   "
12363|NCT03123796|"     Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and     reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this     study, investigation of the effects of PPI use on the outcome of kidney transplant recipients     is aimed.   "
12364|NCT03123783|"     This study is a Phase 1-2 open-label dose escalation study of the immuno-activating     monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with     non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to     establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when     administered in combination with nivolumab. The Phase 2 portion of the study will evaluate     safety and efficacy of the combination.   "
12365|NCT03123770|"     This is a multicentric, open-label,non-randomized concurrent control, 1:1     match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy     regimen DC-T and EC-T in breast cancer patients.   "
12366|NCT03123757|"     This study evaluates the determinants of mobility, measured by the 6-minute walk test, and     its correlation with quality of life in near elderly patients.   "
12367|NCT03123744|"     The investigational drug being tested in this study is palbociclib. Palbociclib is considered     experimental because it is not approved by the FDA for the treatment of all cancers.     Palbociclib is currently approved for use in breast cancer. Palbociclib is a drug belonging     to a family of drugs called kinase inhibitors. These drugs slow or stop the activity of     particular proteins involved in the growth of human cells and in the abnormal growth of     cancer cells. Blocking these proteins may decrease or stop tumor growth. The purpose of this     study is to assess the safety of the study drug, to see how well it is tolerated, and also to     find a safe dose range of the study drug in patients with specific kinds of tumor genetic     changes.   "
12368|NCT03123731|"     HIV is associated with a pattern of neurocognitive deficits, metabolic dysfunction, and an     elevated risk for cardiovascular disease (CVD), phenomena that remain untreated despite the     use of medications to control the disease. This proposal will examine the effect of a     personalized, automated, interactive mobile phone text message intervention (iSTEP) designed     to increase moderate physical activity (PA), decrease sedentary behavior (SB), and promote a     healthy Mediterranean-style diet (MedDiet) in persons living with HIV (PLWH). The     investigators propose that participants who receive the iSTEP intervention will increase the     amount of physical activity, improve their diet, show a reduction in risk factors for CVD,     and exhibit improved neurocognitive performance.   "
12577|NCT03120806|"     Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group     I included women who has their skin closed with subcuticular interrupted mattress suture     using non-absorbable polypropylene, and group II included women who has their skin closed     with subcuticular continous suture using the same suture material   "
12369|NCT03123718|"     The outcome of patients with central nervous system (CNS) relapse in DLBCL is poor, with     median survival times of 2-5 months. This fatal prognosis necessitates CNS prevention in a     subgroup of patients with a high risk of CNS relapse.      Intrathecal methotrexate (ITMTX) has traditionally been used, although its efficacy for CNS     prophylaxis is contradictory. High-dose intravenous methotrexate (IVMTX) has been suggested     as an alternative approach. Considering the lack of evidence supporting the role of ITMTX,     the investigators propose to compare the efficacy of ITMTX and IVMTX for prophylaxis of CNS     relapse in a subgroup of patients with DLBCL at a high risk for CNS relapse.   "
12370|NCT03123705|"     The prevalence of tooth decay and other oral disease are often overlooked indicators of     overall public health. To improve the understanding of oral health in El Paso, the City of El     Paso Health Department has teamed up with Texas Tech University Health Sciences Center El     Paso in a collaborative effort to determine the factors that contribute to poor oral hygiene,     and lead to cavities and periodontitis. The team will collect saliva, oral debris, leftover     teeth and plaque from children and young adults to study oral infections, markers of     inflammation, and other contributors to tooth decay and oral illnesses. Samples also will be     stored for future investigations. This joint effort will provide a better picture of oral     health in El Paso, and will define a framework for prevention, earlier diagnosis, and better     treatment.   "
37853|NCT02790164|"     The main purpose of this study is to test the hypothesis that continuous NMB could improve     outcome in cardiac arrest patients treated with therapeutic hypothermia.   "
12372|NCT03123679|"     Adult patients referred to radiotherapy treatment of primary or secondary malignant     involvement of the lung parenchyma, who are not meeting the exclusion criteria, will be     introduced to the study and suggested to participate in it by the radiotherapist, Dr     Viacheslav Soyfer, M.D. from the Institute of Radiotherapy Tel Aviv (Sourasky) Medical     Center.      They will sign an informed consent and the study will be conducted based on the agreement of     the institutional ethical committee, prior to perfusion study.      Each patient will be evaluated three times: prior to treatment, a baseline evaluation     mid-follow-up period 6 weeks post initiation of radiotherapy and a delayed follow up 6 months     post treatment. Each SPECT/ Low dose CT assessment will take place within two weeks of the     clinical and PFT assessment.      The study will take place within a duration of two years, from recruiting the participating     patients to the completion of the study protocol by the last recruited patient. For the     individual patient, the duration of participation is six months.      Perfusion SPECT/ Low dose CT studies with a non-diagnostic low dose chest CT will be     performed after the I.V. injection of 4 mCi 99m-Tc-MAA. SPECT/ Low dose CT scan will be     acquired immediately post injection on a GE OPTIMA NM/CT 640 camera. In order to obtain a     better definition of the irradiated fields, we will co-register the SPECT/ Low dose CT with     high-resolution CT provided from the Institute of Radiotherapy. In this procedure, the low     dose chest CT is used as a bridge between high resolution CT and the functional imaging     SPECT. Using the Q.Lung segmentation tool, individual whole lung function and lung subunits     will be assessed, and will be correlated to irradiated fields. Calculated data for each study     step will be compared in order to assess the extent of RT induced lung injury.   "
12373|NCT03123666|"     Informed consent obtained from the patient or the patient's legal surrogate. The window for     randomization and initiation of study drug infusion is 2 days from day of Admission. All     further time points are relative to the day of randomization. Patients will be randomized     (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of     10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects     will be stratified based on Child status. Patients who fulfil the inclusion criteria will     receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and     inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline     nebulization). Standard medical care will be given in both limbs.   "
12374|NCT03123653|"     -  Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year        -  Study design:Prospective,Interventional (single arm study)        -  Study period: 2 year: January 2017 to December 2018        -  Sample size: All the patients during the study period fulfilling the inclusion criteria          will be included.        -  Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks        -  Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline,12 weeks,24 weeks,48 weeks          ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month        -  Adverse effects: The most frequently reported side effects of IFN-based therapy are          flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the          injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and          thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis   "
12375|NCT03123640|"     Aim/Objective: Investigate the effect of implementing a working model for performing     medication reconciliation (MR) and medication review (MRe) in the emergency department (ED),     on readmissions, patient safety and efficiency of the stay in the ED and the hospital.     Research design: randomized, controlled, non-blinded trial. Control group; standard care.     Intervention group; MR and MRe performed at admission to the ED by a clinical pharmacist in     the interdisciplinary team. The intervention is based on a working model for MR, developed in     our initiation project, and it will be adapted to also include MRe. Key challenges in this     research field: Currently no implemented systematic model ensuring that the patient`s correct     medication list is obtained and assessed at the point of admission. There is lack of studies     investigating the clinically outcome of performing MR and MRe in the ED. Lack of knowledge on     the extent of drug related hospital admissions in Norway. These challenges are also     recognized and prioritized by the Norwegian authorities. Impact and utility: The results from     this study will give important answers to the challenges listed above. The results could     imply a huge impact on how to organize ED in Norway regarding drug safety. If the hypothesis     of this study is confirmed, implementing the intervention described will increase patient     safety, both the hospital and society can reduce health care expenses from readmissions, and     also the readmission-burden can be reduced for the patients.   "
12385|NCT03123510|"     The objective of the trial is to study how a synbiotic treatment will affect weight loss and     management in individuals enrolled in weight loss diet Profile®. The investigators propose to     follow up 2 cohorts of Profile® subjects during 6 months. One group will receive a synbiotic     treatment supplement (Bifidobacterium spp plus bimuno- galacto-oligosaccharides (B-GOS))     while the other group will receive placebo capsules. Anthropomorphic and metabolic analysis     will be performed by-monthly. Fecal samples will be obtained before and after the dietary     intervention and samples will be sequenced trough next generation DNA sequencing to analyze     the gut microbiota. Because dietary interventions with high protein and low glycemic index     have been shown to be effective in reducing weight, but has also been linked to potential     colon harm due to increased fermentation of undigested protein on the colon, the     investigators expect supplementation of Profile® with a synbiotic product will lead to an     increased overall wellbeing without compromising weight management.   "
12376|NCT03123627|"     Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in     CMV-seropositive renal transplant recipients receiving induction thymoglobulin when     developing CMV-specific cellular immunity after transplantation.      Objective Meet the efficacy and safety of valganciclovir prophylaxis suspend in     CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific     transplant, receiving Thymoglobulin induction and maintain cellular immunity-specific CD8 +     CMV after transplantation.      Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant     recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV)     received induction with thymoglobulin      Patients meeting inclusion criteria will be randomized to:        -  Control Arm: valganciclovir prophylaxis until day +90 as recommended by the          International Consensus document of the TTS (Transplantation 2013:96:333-360).        -  Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific          cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the          patient developed CMV-specific cellular immunity. Patients who did not develop CMV          specific immunity continue prophylaxis until day +90.      Analysis: The incidence of CMV disease according to the strategy used was calculated using     Kaplan-Meier curves that were compared using the log-rank test.   "
12377|NCT03123614|"     Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially     vision-threatening postoperative complication of PRK. Topical ophthalmic corticosteroids are     routinely prescribed by most surgeons postoperatively to help prevent this complication.      Goals of topical steroids use after PRK include effective modulation of the healing response     to prevent corneal haze while at the same time minimizing side effects, such as intraocular     pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that     exerts its therapeutic effects and is then quickly changed into inactive metabolites. This     relatively fast metabolism of loteprednol gives it a lower side effect profile than other     steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature,     there is currently no consensus on a standard regimen or which type of corticosteroid should     be used after PRK.      Investigators are conducting a prospective, randomized trial to compare the incidence of     intraocular pressure rise and visually significant postoperative corneal haze after PRK with     the use of loteprednol 0.5% gel compared to the use of earlier generation steroids,     prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.   "
12378|NCT03123601|"     BACKGROUND: Prior research has shown a relationship between dehydration, falls and pulmonary     aspiration among older adults in nursing and health care facilities, which contributes to its     loss of independence and quality-of-life. Is believed that improving communication among     health professional decreases the number of adverse events in institutionalized patients.     This study will evaluate the feasibility of a set of sign displays designed to communicate     fall, dehydration and pulmonary aspiration risks and will reflect on tailored interventions     to manage these events in nursing homes.      METHODS AND ANALYSIS: This will be a national, single-center, feasibility study. All     patients, with chronic neurologic diseases selected from a nursing home, will be invited to     participate. At baseline patients will undertake a screening risk assessment and it will be     attributed a correspondent risk display. Study duration will be a minimum of 3 months per     participant, including daily record of events and monthly interview assessments. Events data     will be compared with historical data extracted retrospectively from medical and nursing     charts.   "
12379|NCT03123588|"     The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus     anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of     hydroxyurea.   "
12380|NCT03123575|"     This will be a cross-sectional population-based study carried out in the region of Madrid     (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in     HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and     to compare the number of Co-meds between the ART-treated population and HIV-uninfected     population in the region of Madrid, categorized by age and gender.   "
12381|NCT03123562|"     The purpose of this study is to evaluate the safety and effectiveness of stem cells for     cerebral palsy related to neonatal jaundice   "
12382|NCT03123549|"     This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify®     Disc) is at least as safe and effective as conventional anterior cervical discectomy and     fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at     two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit)     with or without neck pain or myelopathy due to abnormalities localized to the levels of the     two contiguous disc spaces in subjects who are unresponsive to conservative management.   "
12383|NCT03123536|"     There is currently a lack of evidence to support the use of perioperative point-of-care     ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this     study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the     worse postoperative outcomes in high surgical patients.   "
12384|NCT03123523|"     Anderson-Fabry disease is a genetic lysosomal storage disease, linked to chromosome X (gene     GLA), responsible of enzyme synthesis deficit in α-galactosidase A with intracellular     sphingolipids accumulation and multiorganic achievement.      If renal complication is principally responsible of the pejorative evolution of the disease,     it may also exist a cardiac achievement, symptomatic or not (heart failure symptoms including     dyspnea, conduction abnormalities, supra-ventricular and ventricular arrhythmias), with or     without left ventricular hypertrophy (LVH).      Administration of agalsidase-α or ß, a genetic engineering synthetic equivalent of the     deficient enzyme, should significantly slow disease evolution indeed reduce LVH.      Some patients with Fabry disease without LVH should present, compared to healthy subjects,     indirect early markers of intramyocyte lipid overload:        -  in echocardiography, longitudinal myocardial deformation (strain) should be altered          while ejection fraction is preserved, and        -  in cardiac MRI, T1 mapping should be reduced1. This was also previously demonstrated in          Fabry patients with LVH2. However, are these abnormalities of longitudinal deformation          in echocardiography and of T1 mapping in MRI correlated to the presence of pejorative          cardiac markers (such as clinical and functional tolerances, Brain Natriuretic Peptide          (BNP) level and electrical complications)?   "
12386|NCT03123497|"     Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura     according to the type of treatment   "
12387|NCT03123484|"     Epidermal Growth Factor Receptor tyrosine-kinase inhibitors （EGFR-TKIs）, including     gefitinib，erlotinib and icotinib demonstrate excellent effect on the treatment of non small     cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially     sensitive to the drugs eventually become resistance. In this study, the investigators aim to     explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung     cancer with EGFR-TKI resistance.   "
12388|NCT03123471|"     This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the     efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque     psoriasis of the scalp.      Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be     randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first     16 weeks.   "
12389|NCT03123458|"     The primary objectives are to evaluate the safety and efficacy of infusion of the third party     fully-characterized clonally derived fetal MSCs (cfMSCs) for the control of severe symptoms     associated with acute and chronic immune-related disorders and tissue damage.   "
12390|NCT03123445|"     Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection     pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung     cancer and maintenance treatment.   "
12397|NCT03121599|"     The Main purpose of this project to study the uptake pattern of FLT-PET and it is value in     assessing the malignant hematopoiesis in MPN within the pediatric age group, in terms of     diagnosis, staging and monitoring response to therapy. As well as, evaluating FLT-PET as a     novel non-invasive technique in cases with MPN and its role in comparison to the standard     bone marrow biopsy with regard to disease diagnosis, assessment of disease activity,     detection of transformation, monitoring of treatment response and grading of     fibrosis.Furthermore, we aim to study the association of FLT-PET uptake patterns with     different genetic makeup (JAK2, CALR positive, MPL, or Triple negative disease) or allele     burden in cases of Pre-PMF with the ability of FLT-PET to differentiate between Pre-PMF and     ET.      Although MPNs are diseases of elderly, MPN is diagnosed in younger age groups in a     considerable number of cases. Since most of the available data as well as current WHO     classification criteria emphases on the average MPN patients who range in age between 55     and 65 years. Less consistent data are available in the groups of patients presenting below     this median age, such as children and younger adults which we're planning to reveal.   "
12398|NCT03121586|"     To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of     adjunctive treatment in subjects with schizophrenia   "
12399|NCT03121573|"     The aim of this study was to investigate the effects of duloxetine on improvement of brain     cortical activity in patients suffering from major depressive disorder using near infrared     spectroscopy.   "
12400|NCT03121560|"     Menorrhagia is frequent and occur in 11 to 13 % of the general population. It accounts for     20% of the gynecological consultations and tends to increase with age. It can be the first     symptom of a mild uterine disease or cancer (cervical or endometrial), especially if the     patient is older. The most common causes are polyps, adenomyosis, fibroids, hyperplasia and     cancer.      Menorrhagia needs to be investigated -especially after menopause, when the prevalence of     endometrial cancer is higher (10-15%). For premenopausal metrorrhagia, the assessment will be     made if a pathology is suspected or if there is no response to the medical treatment within 3     to 6 months.      The medical check-up consists in the first instance in a questionnaire, a clinical     examination and an endovaginal ultrasound examination. If the endometrium is thickened, a     focal pathology is suspected, or if the bleeding persists despite a normal endovaginal     ultrasound result, further examinations including a possible biopsy are required.      While hysteroscopy is widely accepted as a standard examination for uterine cavity     exploration, a meta-analysis showed that the diagnostic performance of hysterosonography was     equivalent. Both are carried out on an outpatient basis during a gynecological consultation     and require no special preparation. Several studies seem to show that hysterosonography is     less painful, causes less discomfort and is therefore more accepted by patients than     hysteroscopy. This is why many practitioners continue to prefer it to hysteroscopy and     associate it with the Pipelle of Cornier for the assessment of postmenopausal metrorrhagia.      However, if endometrial cancer is confirmed, the histological type detected within the biopsy     is the main predictor of the severity of the disease and the treatment to be given. It is     therefore essential to have an accurate biopsy sampling prior to therapeutic management. It     is not the case with blind biopsies (without visual control). Indeed, some studies showed     that the concordance between the optical aspect of the endometrium under hysteroscopy and the     histological result was close to 90%, validating the hypothesis of an improved sensitivity     through visual control.      The American College of Obstetricians and Gynecologists (ACOG) currently recommends an     endovaginal ultrasound assessment followed by an endometrial biopsy in the event of a     thickened endometrium or when a pathology is suspected. A biopsy can even be taken during the     consultation, at the onset of the complaints. The last recommendations of December 2010 leave     the choice to clinicians regarding the histological diagnostic modalities (a blind biopsy     with the Pipelle of Cornier or a targeted biopsy under hysteroscopy), although the biopsies     under hysteroscopy are recommended since 2015. However, despite its poor sensitivity, the     most widely used technique in the world is the blind biopsy by aspiration performed after     vaginal ultrasound or hysterosonography because it is an easy low cost method.      The development of hysteroscopes with a smaller diameter and the introduction of the     vaginoscopy have considerably increased the tolerance of this examination. In addition,     hysteroscopy allows a simultaneous therapeutic intervention for certain indications, which is     comfortable and well accepted by the patients. Unfortunately, there are few studies comparing     the tolerance of the two examinations performed according to the current recommendations of     good practice of hysteroscopy. Only one comparative randomized study in 2008 showed that     saline infusion sonography (SIS) was less painful than hysteroscopy with vaginoscopy.     However, direct comparison was impossible since women only had one of the two examinations.      The Brugmann University Hospital set up a consultation called one stop bleeding clinic in     which the two examinations are performed for each patient with abnormal bleedings, in order     to increase diagnostic performance.      All included patients will thus undergo a saline infusion sonography (SIS) and a hysteroscopy     (HSC). Each procedure will be evaluated on pain level (EVA scale) and tolerance by the     patient.   "
12401|NCT03121547|"     While the analgesic effects of opioids are well known, evidence suggest that there are     differences in the adverse dizziness of the different opioid types, which may influence the     gait function differently. However, this has not been investigated scientifically under     controlled conditions. Normal gait function is characterized by cyclic movements with a high     degree of predictability. As such, the amount of kinematic variability can provide important     information about a condition or an intervention that may affect the gait function .     Three-dimensional gait analysis is a recognized method to assess changes in stride-to-stride     variability associated with a medical condition or caused by an intervention. Thus, opioid     induced changes in gait variability, and possible differences between opioid types, can be     assessed objectively from differences in the variability of movements obtained from a     three-dimensional gait analysis.      The purpose of this study is to investigate differences in gait variability induced by two     different single-dose opioid formulations and an inert placebo in healthy volunteers and knee     osteoarthritis patients.   "
12402|NCT03121534|"     The goal of this clinical research study is to learn if blinatumomab can help to control     Richter Transformation (RT, a type of blood cancer). The safety of this drug will also be     studied.   "
12403|NCT03121521|"     Introduction. Statins are generally well tolerated but not devoid of side effects. Quite     often it is manifested by asymptomatic increase in the level of aspartate and alanine     aminotransferase. In such cases patients to administer hepatoprotective drugs, but most of     them used for this purpose are ineffective. The aim of this study was assess the usefulness     of melatonin in counteracting the adverse hepatic events from statins. Methods. The research     program included 60 patients(aged 47-65 years, 41 women and 23 men)with hyperlipidemia taking     atorvastatin or rosuvastatin in dose 20-40 mg daily. The patients were randomly allocated in     two groups. Group I (n=30) was recommended to take the same statin at a standardized daily     dose of 20 mg together with melatonin at a dose 2 x 5 mg, at 7:00 and 21:00. In group II     (n=30) patients took statins with placebo at the same time of the day. Follow-up laboratory     tests (AST, ALT, GGT, ALP, cholesterol, triglycerides) were evaluated after 2,4 and 6 mounts     of treatment.   "
12404|NCT03121508|"     The program will consist of diabetes self-management sessions, led by an occupational     therapist. The sessions will be held in an individualized format. Sessions will focus on     diabetes education, self-management education, and education on behaviors and adaptive     techniques to optimize participation in daily life with type II diabetes. As occupational     therapists, the investigators and facilitator, aim to focus on establishing healthy habits,     roles, and routines for individuals with type 2 diabetes.   "
12419|NCT03123172|"     Study will be conducted on 20 patients ASA III-IV undergoing orthotopic liver     transplantation. Blood samples will be obtained simultaneously from arterial line, pulmonary     artery catheter and central venous catheter at 4 specific time points baseline, immediately     after insertion of PAC; at the end of the dissection phase; 30 minutes after anhepatic phase;     30 minutes after unclamping. Blood samples will be also obtained whenever PPV is more than     15% and patient will need fluid therapy   "
12420|NCT03123159|"     The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in     the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the     study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the     intended use population.   "
39806|NCT02764593|"     This study will evaluate the safety of adding nivolumab to several chemotherapy platforms     with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.   "
12405|NCT03121495|"     It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)     worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong     Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based     on data from 2013.      CRC is one of the most preventable cancers because its development in general follows an     adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC.      While early detection and removal of colorectal adenoma by screening colonoscopy with     polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after     a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to     account for up to 10.5% of CRC. The protective effect of colonoscopy against cancer in the     right colon has not been consistently demonstrated. Interval CRC has been associated with     proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination,     incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR).      High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC. Methods that     can improve polyp detection in the right colon such as retroflexed examination of the right     colon, second forward view examination of the right colon, use of colonic fold flattening     device, colonoscope with an increased field of view may potentially reduce the risk of     interval CRC, but data is still limited. Performance of a second forward view (SFV)     examination of the right colon may be the easiest and safest from a practical standpoint when     compared to other options (eg, additional training is often needed for retroflexed     examination of the right colon since there may be a potentially higher risk of perforation in     endoscopists not familiar with the technique, additional equipment is needed when using a     colonic fold flattening device, or a colonoscope with an increased field of view).      Our current study aims to determine whether a routine SFV examination in the right colon can     lead to an increase in adenoma / polyp detection when compared to conventional withdrawal     examination in the right colon in both male and female patients undergoing screening and     surveillance colonoscopies.   "
12406|NCT03121482|"     Prospective multicenter randomized controlled open-label trial comparing 2 strategies of     oxygenation during the post-extubation period in ICU patients at high risk of extubation     failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.   "
12407|NCT03123328|"     This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse     oximeter and sensors in a trauma setting.   "
12408|NCT03123315|"     The purpose of this study is to improve the safety of surgery to remove a uterus (a     hysterectomy) by better understanding where a patient's ureters lie.   "
12409|NCT03123302|"     In this study we aim to investigate the relationship between our anesthesia practice and post     procedure complications after MRI scanning with sedation. This is a prospective, single     center observational study. All patients undergoing MRI scan during the study period will be     included. The only exclusion criteria is the refusal of patients to participate to the study.   "
12410|NCT03123289|"     In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients     with failed joint prosthesis and compare it with that of conventional     18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography     (PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects     with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within     24-48 hours from each other, will be performed within 4 weeks before surgical     evaluation/revision of the hardware.   "
12411|NCT03123276|"     Soft tissue sarcomas (STS) are a group of rare mesenchymal neoplasms affecting all ages. STS     most commonly present as localised disease but despite surgery and adjuvant treatment more     than half of patients will develop recurrent or metastatic disease. Leiomyosarcoma (LMS), a     malignancy of smooth muscle, is one of the most common STS and undifferentiated pleomorphic     sarcoma (UPS) is a common sarcoma sub-type with aggressive symptoms.      Recent studies have demonstrated reasonable sensitivity of LMS to gemcitabine monotherapy     with an objective response rate of 8-19%. However the overall survival is still only about 12     months which illustrates the critical clinical need for improved therapies for advanced STS     and sarcoma in general.      In this study the investigators propose to combine the immune synapse checkpoint inhibitor     with the cytotoxic and immune modulating agent, gemcitabine. It is hoped that this dual     immunomodulatory approach will enhance the effect of pembrolizumab on PD-L1 expressing LMS     and UPS, leading to a safe treatment with patient outcomes. This is a two part, phase I,     single centre dose escalation and dose expansion study in the total of 24 patients with newly     diagnosed metastatic or inoperable LMS and UPS. There will be approximately 12 patients in     the dose escalation cohort (part A) and the starting dose will be a fixed dose rate (FDR)     gemcitabine of 800 mg/m2 on day 1 and 8 of 21 days cycles in combination of 200 mg of     pembrolizumab given as an infusion on day 1 every 3 weeks. The MTD cohort (part B) will then     be expanded to a total of 12 patients in order to further evaluate the safety and     tolerability of that dose as well as to preliminarily assess response to therapy.      The study is sponsored by Royal Marsden NHS Foundation trust and the funding for the study is     provided by Merck Sharp & Dohme Limited.   "
12412|NCT03123263|"     This study retrospectively looks at changes in Echocardiographic parameters while using     transtuzumab   "
12414|NCT03123237|"     the investigators explore the possible role of DMSA to detect renal affection in diabetic     &/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control &     diabetic &/or hypertensive patients.   "
12415|NCT03123224|"     This study evaluates the effect of a physical exercise + caregiver skills training on     feelings of burden, mood, and biological markers of inflammation in persons who provide care     for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and     flexibility + caregiver skills training program, while the other half will participate in a     moderate/high intensity aerobic and resistance + caregiver skills training program.   "
12416|NCT03123211|"     This is an expanded access program (EAP) for eligible participants. This program is designed     to provide access to Veliparib prior to approval by the local regulatory agency. Availability     will depend on territory eligibility. Participating sites will be added as they apply for and     are approved for the EAP. A medical doctor must decide whether the potential benefit     outweighs the risk of receiving an investigational therapy based on the individual patient's     medical history and program eligibility criteria.   "
12417|NCT03123198|"     This protocol establishes a research oriented psychological treatment clinic within the     Graduate School of Applied and Professional Psychology (GSAPP), called the Dialectical     Behavior Therapy Rutgers University Research Program (DBT-RU). The overall aim of the     proposed research is to find ways to improve therapist training in existing treatments for     complex and difficult-to-treat problems (e.g., DBT, prolonged exposure), develop new and more     effective treatments, and improve understanding of severe psychopathology. Consequently, this     proposed research will have four branches: (1) training of research clinicians and evaluation     of training methods; (2) training of clinical evaluators for the research studies and     evaluation of assessment training methods; (3) assessment of treatment outcome, including     assessment of mediators and moderators of change (both clinician and client data); (4)     assessment and analyses of psychopathology of subject populations who participate in the     DBT-RU.   "
12418|NCT03123185|"     Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising     doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects   "
41551|NCT02741752|"     The purpose of this randomized clinical trial was to evaluate the effect of cortical bone     decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.   "
12421|NCT03123146|"     Individuals with high functioning autism spectrum disorder (ASD) frequently experience     obsessions and/or compulsions that are similar to those specified in Diagnostic and     Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive     disorder (OCD). However, little research exists on effective interventions for OCD symptoms     (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional     behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components     (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response     prevention) as well as function-based behavioral assessment will be evaluated. Participants     will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary     outcome measures will be used to evaluate the efficacy of the treatment, and will be     administered at pre and post-intervention as well as six month follow-up.   "
12423|NCT03123120|"     The objectives of this trial are safety and efficacy (proof-of-concept) of induction of     mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative     colitis and persisting endoscopic activity despite pre-existing TNFi treatment.      This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to     achieve the similar exposures as the highest exposures tested and found safe and tolerable in     preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing     TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include     assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific     biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help     understand BI 655130`s mode of action.   "
12424|NCT03123107|"     Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery     that increases the incidence of stroke, kidney injury and death. Vitamin C has been shown to     decrease the incidence of POAF follow cardiac surgery, but the optimal dose has not been     identified. With this project, the investigators plan to gather pharmacokinetic and     dose-response data for vitamin C in the cardiac surgery population. The investigators plan to     conduct a small interventional pilot study investigating the pharmacokinetics and     pharmacodynamics of Vitamin C in patients undergoing coronary artery bypass graft (CABG)     surgery. Patients enrolled will receive an intravenous dose of Vitamin C the day before     surgery and the day after. Patients will have blood samples obtained with each dose for     analysis of vitamin C concentrations and several biomarkers of oxidative stress. Analysis of     samples will be performed within the Department of Pharmaceutical Sciences at Wilkes     University.   "
12425|NCT03123094|"     The primary objective of this trial is to investigate the safety and tolerability of BI     655130 following administration of single rising intravenous doses and single subcutaneous     dose in healthy Japanese male volunteers.      Secondary objective is the exploration of the pharmacokinetics including dose proportionality     of BI 655130 in healthy Japanese male volunteers.   "
12426|NCT03123081|"     The purpose of this study is to investigate the efficacy and safety of umbilical cord milking     in depressed neonates at birth for prevention of hypoxic ischemic encephalopathy.   "
12427|NCT03123068|"     This double-blind, placebo-controlled proof-of-concept clinical trial is intended to     demonstrate that preemptive oral administration of cocoa flavanol for five days before     surgery will attenuate the surgery-evoked increase of HMGB1 in blood plasma and NFkB     signaling in innate immune cells shortly after surgery. A secondary aim is to capture     preliminary patient-centered outcomes data and relate these outcomes to the intake of oral     cocoa flavanol and surgery-evoked activation of the HMGB1-NFkB signaling axis. Participants     will be randomized to receive either an over the counter supplement containing cocoa     flavanols, or placebo, for 5 days before surgery.   "
12428|NCT03123055|"     This is a Phase 1b multi-center, single-arm, open-label study to determine the effects of     B-701 alone on markers of FGFR3 pathway inhibition and to assess the safety, tolerability and     efficacy of B-701 plus pembrolizumab in the treatment of subjects with locally advanced or     metastatic UCC, who have progressed following platinum-based chemotherapy and who have not     received prior immune checkpoint inhibitor therapy.   "
12429|NCT03123042|"     Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric     cancer patients with the risk of lymph node metastasis after endoscopic resection and     preparation of multicenter phase 3 trial of stomach preserving surgery in these patients.      Contents: The number of enrollment is 247 patients. The patients underwent endoscopic     resection for early gastric cancer, and the tumor was defined to be out of indication for     endoscopic resection pathologically. So, additional gastrectomy is recommended for them.      The investigators will enroll patients who agree this study. After general anesthesia,     Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin     will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel     lymph node will be identify in back table dissection, and patients will undergo conventional     gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.   "
12430|NCT03123029|"     This is an expanded access program (EAP) for eligible participants. This program is designed     to provide access to Venetoclax prior to approval by the local regulatory agency.     Availability will depend on territory eligibility. Participating sites will be added as they     apply for and are approved for the EAP. A medical doctor must decide whether the potential     benefit outweighs the risk of receiving an investigational therapy based on the individual     patient's medical history and program eligibility criteria.   "
12444|NCT03122847|"     Continuous use of systemic glucocorticoids decreases bone mineral density and increases     fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous     glucocorticoid. The investigators aim at investigating whether this treatment regimen also     affects bone metabolism.   "
12450|NCT03122769|"     The purpose of the study is to evaluate if metformin is taken up into the failing myocardium.     Recent experimental and epidemiological studies have shown beneficial effects of metformin on     heart failure. It is unknown whether this effect is direct or indirect.      The aim of the study is to investigate if metformin is taken up in heart failure using a     novel 11C-metformin tracer and positron emission tomography (PET).   "
12451|NCT03122756|"     *Aim of the Work This study aims to assess the efficacy of intravenous injection of     dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women     undergoing cesarean section.   "
12431|NCT03123016|"     Vitiligo is a common acquired disorder of pigmentation affecting 0.5% to 1% of the world     population. Sharply demarcated patches of depigmentation, which can affect all ethnicities,     and can lead to cosmetic disfiguration and psychosocial distress, characterize the disease.     The etiology of vitiligo remains unknown. Various mechanisms have been proposed, such as     autoimmunity, self-destruction, biochemical, genetic, neural, oxidative stress, and an     imbalance of epidermal cytokines leading to inflammation and selective loss of epidermal     melanocytes. Currently, the most popular theory is autoimmunity. Previous studies noted that     around 25-30% of patients have at least one other autoimmune disease, such as autoimmune     thyroid disease, Addison's disease, pernicious anemia, and alopecia areata. Currently, NB-UVB     phototherapy is the most widely used therapeutic option for vitiligo affecting more than     10-20% of the skin surface, as it is generally considered to be a safe initial treatment.     Potential side effects include phototoxic reaction, thickening of the skin and     koebnerization. NB-UVB is a band of UV radiation with a wavelength of 311-313 nm. UVB induces     mitogenesis and migration in melanocytes mediated by several factors such as IL-1, TNF alpha,     and leukotriene C4. UV radiation produces increased number and activity of melanocytes,     increased melanin density, elongation and branching of dendrites, with increased transfer of     more heavily melanized melanosomes to keratinocytes, seen clinically as increased     pigmentation. Apremilast is an oral small molecule phosphodiesterase-4 (PDE4) inhibitor that     has been shown to regulate inflammatory mediators. Apremilast enters cells by passive     diffusion and, once intracellular, binds PDE4. PDE-4, the dominant phosphodiesterase     expressed in immune cells, degrades cyclic AMP (cAMP) into AMP. PDE4 inhibition thereby     elevates intracellular cAMP, which can down-regulate the inflammatory responses such as     TNF-α, IFN-γ, interleukins (IL) 2, 12 and 23 through mechanisms such as partially inhibiting     expression of inflammatory cytokines and increasing expression of anti-inflammatory mediators     such as IL2 and IL10. The hypothesis is that apremilast will shut down the inflammatory     insult in vitiligo and NB-UVB phototherapy will then be able to regenerate melanocytes and     their activity. By examination of skin biopsies taken pre- and post-therapy, the study team     aims to assess changes in immune and cellular markers in affected skin.   "
12467|NCT03122548|"     The purpose of this study is to determine whether CRS-207 in combination with pembrolizumab     is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal     junction, or esophageal cancer who have received 2 prior systemic chemotherapy treatment     regimens for advanced disease.   "
12432|NCT03123003|"     Bone age assessment in children is based on the interpretation of hand x-ray scans according     to Greulich and Pyle (GP) standard atlas and frequently used for evaluating growth and     puberty in children and adolescents.      To address the disadvantage of repeated irradiation, the need for specialized radiation     centers, heavy equipment and subjective reading a new device, SonicBone was developed.     SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves,     propagating along a measured bone distance. The aim of the study is to evaluate an ultrasound     based device, SonicBone, compared to the current method in children. We will be compared the     US assessment to available bone age X-ray that exists in the medical files of the patients.     we will not do bone age X-ray scans especially for the current study.   "
12433|NCT03122990|"     The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus     full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical     periodontal treatment in patients affected by periodontitis and high blood pressure.   "
12434|NCT03122977|"     The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus     full-mouth treatment (FM-SRP) in terms of acute-phase responses following no surgical     periodontal treatment in obese patients affected by periodontitis.   "
12435|NCT03122964|"     The primary objective of this study is to evaluate the performance of the methylation marker     panel for the detection of bladder cancer in patients with gross or microscopic hematuria.   "
12436|NCT03122951|"     The Clearblue® Advanced Ovulation Test is designed for home use by women who are either     planning or trying for a pregnancy.      The purpose of this protocol is to demonstrate that lay-users representative of the target     user population are able to use the product in the intended user environment.   "
12437|NCT03122938|"     To assess the effects of a lactoferrin supplemented formula on fetal development , iron     metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant     women (24<gestational weeks<26) are enrolled and randomly assigned to     lactoferrin-supplemented formula group (active group) or normal formula group (control group,     without lactoferrin supplementation). Subjects allocated in active group consume lactoferrin     supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in     control group consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g     formula) according to the same schedule. Routine blood test including hemoglobin and serum     ferritin, and food frequency questionnaire-based review and 24h*3 dietary record are     performed every 4 weeks during intervention until delivery. Body weight of newborns are     recorded after delivery. The differences in iron deficiency anemia morbility of pregnant     women and anthropometric measurements of newborns between groups would be analyzed after     completion of this study.   "
12438|NCT03122925|"     OBJECTIVE: To measure the tricarboxylic acid (TCA) cycle rate in the dentate nucleus in a     group of control subjects and subjects with Friedreich's Ataxia (FRDA).      HYPOTHESIS: The TCA cycle rate will be lower in FRDA subjects than in controls APPROACH: The     investigators will infuse carbon-13 (13C) labeled glucose and measure the rate of 13C label     incorporation from glucose to glutamate in the brain using in vivo magnetic resonance     spectroscopy.   "
12439|NCT03122912|"     The purpose of this study is to explore the potential differences in the skin of people who     take fish oil versus soybean oil pills.   "
12440|NCT03122899|"     SALLY studies sacroiliac joint fusion with the iFuse-3D implant.   "
12441|NCT03122886|"     This randomized pilot trial studies how well fat emulsion works in preventing     hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin.     Giving lipids before chemotherapy may prevent some drug reactions from carboplatin or     oxaliplatin.   "
12443|NCT03122860|"     This phase 2 study is a placebo-controlled, double-blind, parallel group study of four     concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected     intraarticularly (IA) into the target knee joint of subjects with moderately to severely     symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of     laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread     Pain Index) were identified as confounding variables impacting the overall assessment of both     radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous     study designs while assessing strategies to combat the confounding impact of laterality and     chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes     (PRO) such as pain, stiffness, and function in OA, this study will also include two placebo     cohorts-one cohort that receives a 2 mL IA injection of vehicle, and one cohort that receives     a sham injection (i.e., a needle stick with 0 mL vehicle injected).   "
12445|NCT03122834|"     Heart failure (HF) is one the most common cause of hospitalization and represents the end     stage of a variety of heart conditions; it is associated with significant morbidity and     mortality.The pathophysiology of HF is centered on increased activity in the adrenergic and     renin-angiotensin-aldosterone systems (RAAS), which leads to vasoconstriction and fluid     restriction with further deleterious effect on cardiac function. Β-blockers, angiotensin     converting enzyme inhibitors (ACEIs)/angiotensin II receptor blockers (ARBs) and aldosterone     antagonists reduce activity in these pathways and have shown prognostic benefit, thus are the     foundation of HF therapy.There is a growing body of evidence that variation in proteins     within the sympathetic axis and RAAS influence drug response thus increasingly     pharmacogenetics of HF research is being sought as a way to optimize HF treatment and advance     new drug development in this area.   "
12468|NCT03122535|"     The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient     undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).   "
18686|NCT03040973|"     The rollover study will provide continued treatment and assessment of long-term safety     follow-up in patients receiving capmatinib (INC280) in a Novartis sponsored study and in the     opinion of the Investigator would benefit from continued treatment.   "
12446|NCT03122821|"     Noninvasive brain stimulation (NIBS) refers to a group of modalities that are used to induce     electric currents to and within the brain for diagnostic or therapeutic purposes. Two major     types of NIBS techniques are currently in use on humans for clinical and research     applications: Transcranial Magnetic Stimulation (TMS) and Transcranial Current Stimulation     (tCS). Moreover, the studies evaluating the clinical benefit of mental practice in stroke so     far are mostly small feasibility studies, while the few randomized controlled trials reported     had relatively small sample sizes. As such, the evidence for mental practice in the treatment     of movement disorders following stroke, and other neurological conditions, remains somewhat     anecdotal. Purpose of our research is to show the effect of combining brain stimulation and     mental imagery on functional recovery of upper limb in stroke.   "
12447|NCT03122808|"     Excessive uterine activity may be one of several aetiological factors that contribute to     depressed neurological function in the newborn. During labour, uterine contractions can     compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction     rates greater than 7 in 15 minutes are associated with an increased risk of neonatal     encephalopathy.      The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more     than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition,     excessive uterine activity is common and, at best, a non-specific predictor of depressed     neurological function in the newborn. There is a need for predictors of neonatal     encephalopathy that are more specific and clinically applicable.      Contraction and relaxation duration are two measures that closely reflect the proposed role     of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged     contractions with short relaxation periods result in progressive reductions in fetal cerebral     oxygenation. Shorter uterine contraction periods are associated with an increased risk of low     umbilical cord potential of hydrogen (pH) values.      Our primary aim is to measure parameters of uterine activity, for example relaxation and     contraction duration, and determine their relationship with the risk of neonatal     encephalopathy. We will also investigate how measures of uterine activity interact with other     measures of labour and fetal well-being, including cervical dilation rates and fetal heart     rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship     of uterine activity with electrophysiological, radiological and developmental outcomes.      We will perform a retrospective case-control study of babies born in the Rotunda hospital     from 2005 until the present. The assessor of the Cardiotocograph (CTG) recordings will be     blind to the disease status of the infants. For each recording, every uterine contraction and     rest interval will be measured. Summary variables created from these measures will be used to     compare the case and control groups. The primary variable will be mean rest interval     duration.   "
12448|NCT03122795|"     Chronic rhinosinusitis (CRS) is a disease associated with impaired quality of life and     substantial societal costs. Though sometimes co-appearing with other conditions, such as     asthma, allergy, and nasal polyps, many cases present without co-morbidities.     Micro-biological diagnostic procedures are frequently undertaken, but the results are often     inconclusive. Nevertheless, antibiotics are usually prescribed, but invariably with limited     and temporary success. Accordingly, there is a need for new treatments for CRS.      Recent studies indicate that the sinuses are colonized by a commensal microbiome of bacteria     and that damage to this natural microbiome, by pathogens or antibiotics, may cause an     imbalance that may promote CRS. Therefore, treatments that restore the commensal microbiome     may offer an alternative to current protocols. Arguably, as suggested by studies on patients     with intestinal infections (next paragraph), one such possibility may be to transfer a     normal microbiome to patients with CRS.      A disrupted microbiome is linked to intestinal clostridium difficile infections. Probiotic     restitution therapy may be effective even in cases recalcitrant to antibiotic treatment.     However, a key to effective probiotic restitution is selecting the bacteria that facilitate     regrowth of normal microbiome. As an answer to this, researchers have chosen to simply     transplant the entire microbiome from a healthy donor. In the case of clostridium difficile     infection in the form of faecal transplants.      In this study, we will examine the possibility to treat patients with chronic rhinosinusitis     without polyps (CRSsNP) with complete sinonasal microbiomes obtained from healthy donors. Our     analysis will focus on symptoms and signs of disease as well as on nasal inflammatory and     microbiological indices.   "
12449|NCT03122782|"     Study Design:      Randomized Controlled Clinical Trial.      Study Population:      The study population will be a consecutive series of participants attending the Early Cancer     Detection Unit (ECDU) at Ain Shams University Maternity Hospital.      80 women who are scheduled to undergo a hysteroscopic myomectomy will be included and will be     randomized into two groups:      Group A: women will undergo a hysteroscopic myomectomy with the use of (TXA) Kapron in the     distention medium      Group B: women will undergo hysteroscopic myomectomy with the use of placebo(normal saline in     the distention medium).      Randomization will be performed using a Computer-generated randomization system.      The allocated groups will be concealed in serially-numbered sealed opaque envelopes that will     only be opened after recruitment.      Patient allocation will be performed prior to the induction of anesthesia by an independent     person, who will not otherwise be involved in this study.      The trial will be appropriately blinded; the participants, outcome assessors and the surgeon     performing the procedure will be blinded to the medication type, which will be used inside     the distention medium.      Therefore, this study will be a randomized double blind prospective clinical      Methodology:        1. Informed written consent obtained from the participant.        2. History             1. Personal history             2. Menstrual history             3. Detailed obstetric history             4. Surgical intervention especially uterine surgeries and any post-operative               complication             5. History of drug intake, especially hormonal treatment or anticoagulant therapy.        3. Routine preoperative investigations in addition to a serum pregnancy test if pregnancy          is suspected.        4. Physical examination including general, abdominal and pelvic examination.        5. Hysteroscopy will be performed in the early proliferative phase using normal saline as a          distention medium.        6. Only in intervention group (TXA group) KAPRON (Tranexamic acid) will be added to the          injected media.             -  In intervention group 500 mg of Kapron for every 500 ml of distending media will be               added.             -  In the control group, placebo .i.e. ,normal saline in the same form will be               injected inside every 500 ml of the distention medium.        7. The trial will be appropriately blinded; the participants, outcome assessors and the          surgeon performing the procedure will be blinded to the medication type, which will be          used inside the distention medium. Therefore, our study will be a randomized double          blind prospective clinical trial.        8. Intraoperative bleeding and quality of view will be observed.        9. A blood sample will be taken from each participant in both groups after 24 hours from          the end of the operation for both hemoglobin and hematocrit levels.      Types of outcome measures:      Primary outcome measures:      Estimated Blood loss defined as comparing the hematocrit and hemoglobin at base line     (preoperative ) and 24 hours after surgery with the Tranexamic acid compared to the control     group.      Secondary outcome measures:      The quality of view, duration of surgery, the volume of injected media, intraoperative     complications and the success of the completion of the operation will be secondary outcomes.   "
12452|NCT03122743|"     This pilot research trial studies the collection of serum samples in studying emotional     stress in patients with prostate cancer. Studying serum samples from patients with prostate     cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol,     substances the body makes when stressed, rise or fall with how patients are feeling and/or if     those levels are related to clinical information related to prostate cancer.   "
12453|NCT03122730|"     The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is     safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the     current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly     obtained with VentaProst titration.   "
12456|NCT03122691|"     This research is being done to measure the effects of both oral and vaporized cannabis     (marijuana), at different doses, on the ability to perform certain tasks such as balancing,     eye tracking, and computerized measures of memory and attention. The investigators will     collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to     see if there are markers in those fluids that can predict performance on the tasks. The     results of this study will help us better understand the effects of using cannabis, and to     help identify behaviors and/or substances in the body that relate to cannabis impairment.   "
12457|NCT03122678|"     To determine if intravenous thiamine would decrease the time to reversal of shock in patients     with septic shock.   "
12458|NCT03122665|"     Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic     hypothermia   "
12459|NCT03122652|"     Multiple sclerosis (MS) is a common cause of severe neurological disability in young adults,     resulting from an autoimmune interruption of both myelin and axons within the central nervous     system (CNS). The diagnosis is made by fulfilling both spatial criteria, by meeting the     requisite number of lesions within the brain or spinal cord, along with criteria for time, by     demonstrating a history of at least a second clinical attack or the development of a new MS     lesion on MRI after the seminal neurological event. In the case of MS, healthy individuals     who do not exhibit signs of neurological dysfunction commonly have brain MRI studies     performed for a reason other than an evaluation for MS that reveal unexpected anomalies     highly suggestive of demyelinating plaques given their size, location, and morphology. These     healthy subjects lack symptomatology suggestive of MS and fulfill formal criteria for     radiologically isolated syndrome (RIS), a recently described MS subtype that expands upon the     phenotype of at-risk individuals for future demyelinating events. The discovery of such     anomalies creates intersecting neuro-ethical, legal, social, and practical medical management     quandaries and is, therefore, of both immediate and long-term clinical significance. Despite     advancements in the characterization of RIS subjects, and in our understanding of risk     factors for initial symptom development, the effect of treatment on such cases remain     unclear.      The purpose of this investigation is to systematically study the efficacy of Teriflunomide in     those individuals who possess incidental white matter anomalies within the brain and     following a MRI study that is performed for a reason other than for the evaluation of MS.      RIS subjects are frequently exposed to disease modifying therapies despite the lack of     scientific literature supporting the use of such treatments. Earlier treatment intervention     may extend the time to the first acute or progressive clinical event resulting from CNS     demyelination and reduce radiological progression. In addition, early treatment may result in     more profound effects on reducing disability progression long-term.      The primary outcome measure for this trial is the time to the first acute or progressive     neurological event resulting from CNS demyelination.      This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.   "
12460|NCT03122639|"     Obstructive sleep apnea (OSA), a condition that affects a quarter of the Western adults,     triples the risk for cardiovascular diseases and increases all-cause mortality. Intermittent     hypoxia (IH) during transient cessation of breathing in OSA leads to endothelial     inflammation, a key step in the initiation and progression of cardiovascular disease.     However, the mechanisms that mediate IH-induced endothelial inflammation remain unclear and,     consequently, no targeted therapy is available for vascular manifestations of OSA. Using     endothelial cells (ECs) freshly harvested from OSA patients, they study team has identified     impaired complement inhibition as an initial stimulus for endothelial inflammation in IH,     thereby linking for the first time complement activation to vascular risk in OSA. The     investigators found that a major complement inhibitor cluster of differentiation (CD59), a     plasma membrane protein that inhibits the formation of the terminal complement membrane     attack complex (MAC) and protects host cells from complement injury, is internalized from the     EC surface in OSA patients. Consequent MAC deposition initiates endothelial inflammation in     IH. Importantly, the investigators showed that IH does not significantly affect inflammation     in ECs in the absence of complement, suggesting that complement activation has an essential     role in endothelial inflammation in OSA. Interestingly, internalization of CD59 in IH appears     to be cholesterol-dependent and statins prevent MAC deposition on ECs in IH in a     CD59-dependent manner, suggesting a novel therapeutic strategy to reduce vascular risk in     OSA. This led the study team to hypothesize that IH-induced cellular cholesterol accumulation     reduces complement inhibition via increased internalization of CD59 from the EC surface     leading to increased MAC deposition, and that treatment of OSA with continuous positive     airway pressure (CPAP) and/or statins reverses endothelial dysfunction by restoring     complement inhibition.   "
12461|NCT03122626|"     After a stroke, people find it difficult to perform everyday activities independently, like     getting dressed, preparing meals, and shopping. This can cause many problems. First, people     with stroke can't do activities they enjoy, like walk outside, or make home repairs. Second,     a family member or friend has to help and has less time to do important activities. If a     family member or friend is not available, someone from homecare services has to help. Third,     people who need help with everyday activities are more likely to visit the doctor, and enter     a nursing home than those who do not need this help. Losing one's independence can decrease     quality of life. Functional exercise classes run by physical therapists where people with     stroke practice getting in and out of a chair, stepping, and walking, can improve the ability     to balance, walk, and do everyday activities. These classes are not commonly available in     community centres, mainly because fitness instructors do not receive training in how to run     exercise classes for people with stroke. Therefore there is a need to make these functional     exercise programs available in local community centres.      The objective of this project is to test procedures for running a large study to see whether     people with stroke improve their ability to do everyday activities after participating in     functional group exercise classes for 12 weeks in local community centres. If ability to do     everyday activities improves, the investigators wish to see if the improvement is still     present 3, 6 and 9 months later. Physical therapists at a nearby hospital will teach fitness     instructors how to run the exercise class, help out during the classes, and answer questions     by email or phone. Before conducting the larger study, it is important to see how many people     with stroke are interested to participate, if they attend all of the exercise classes, and if     they find the evaluations acceptable. It is also important to know whether the fitness     instructors are able to run the program as planned, if managers at the hospital and     recreation centre find the cost of running the exercise program acceptable, and if the     improvements people make are large enough to support the decision to run a large study.      In Toronto, London and Pembroke, Canada, managers at a hospital and a nearby recreation     centre have agreed to help run the exercise program. The physical therapist will ask people     with stroke who can walk and are being discharged home from the hospital whether they can be     called about the study. People with stroke and a family member who agree to participate in     the study will complete four evaluations when they enter the study, and 3, 6, and 12 months     later. At each evaluation, people with stroke will perform tests of balance and walking, and     complete questionnaires about their mood, participation in valued activities, and quality of     life. Family members will complete a questionnaire about the help they provide. After the     first evaluation, the investigators will use a process like flipping a coin, to see if the     person with stroke will begin the exercise program immediately or 12 months later. The     investigators will call people each month to ask if a fall occurred, and obtain data on     doctor and hospital visits. The investigators will interview exercise participants, family     members and hospital/recreation staff at the end of the study to ask about the experiences.      This project is unique because the program combines the expert knowledge and skills of     physical therapists and fitness instructors. Because a physical therapist is involved, people     with stroke feel the program is credible and the exercises will be suitable. The exercise     program involves practicing everyday movements, making the exercises easy for fitness     instructors and people with stroke to learn. Each exercise has multiple levels of difficulty     so the instructor can adapt exercises to how the person is feeling. The exercise program does     not require expensive equipment (e.g. chairs, stepping stools) and therefore can be offered     in most community centres. Finally, an extensive network of hospitals providing stroke care     and community centres run by recreation organizations exists in Canada. Thus, if this program     is beneficial, it could easily be made widely available.      The number of Canadians living with the effects of stroke will increase to between 654 000     and 726 000 over the next 18 years. Eighty percent of these individuals will live at home.     This means that a large number of Canadians will be faced with challenges performing everyday     activities that will affect their family members, threaten their ability to live on their     own, and result in substantial healthcare costs. The investigators need functional exercise     programs in local community centres now so that these people can have the opportunity to     improve their ability to function and live independently in the community   "
12462|NCT03122613|"     UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The efficacy     of mesalazine in preventing relapse in patients with UC is well-known and supported by     randomized studies. However, mesalazine can be associated with side-effects. In addition,     drug compliance is suboptimal, especially when disease is not active. Curcumin is a natural     phytochemical derived from the Indian spice turmeric. It is widely used, has potent     anti-inflammatory, anti-oxidant and anti-tumour properties.      The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy     of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).   "
12463|NCT03122600|"     the applicability of ankle brachial index (ABI) and B-type natriuretic peptide (BNP)     measurement as cardiovascular risk prediction models during hospital stay in elderly patients     undergoing vascular surgery.   "
12464|NCT03122587|"     The will investigate the feasibility and effectiveness of non-invasive transcranial     alternating current stimulation (tACS) among treatment seeking substance users.   "
12477|NCT03122418|"     Approximately half of the variation in the presentation and disease status of patients with     Cystic Fibrosis (CF) is secondary to non-genetic variables.[1] These include household     income, compliance with therapy, second hand smoke exposure and possibly exercise (although     exercise has less evidence to support its influence on disease status). Recently increased     attention has been focused on the role of exercise and quality of life for patients with CF.     This study will evaluate the role of exercise in relation to the patient's perception of     their quality of life. The primary outcome will be the overall change in the patient's Cystic     Fibrosis Questionnaire - Revised (CFQ-R) over a one year period during which the participants     are encouraged to exercise and use a personal fitness device to track their exercise. This is     a prospective single group non-blinded study. Participants will be asked to wear a personal     fitness device for 11-13 months. The change in CFQ-R score is the primary outcome and other     secondary outcomes will include; (1) exacerbations of cystic fibrosis (through use of     antibiotics), (2) change in subject's FEV1, (3) inpatient admission rates, (4) change in BMI     and (5) change in 6 minute walk test. The study will take place at the Adult CF Clinic on the     University of Oklahoma Health Sciences Center campus.   "
12478|NCT03121469|"     Phase 1/2 study, open, monocenter, non-randomized   "
12465|NCT03122574|"     The purpose of this research was to estimate feasibility of an aromatherapy pain management     intervention to reduce pain and distress caused by venipunctures in a pediatric population.     The feasibility of the use of aromatherapy essential oil lavandula angustifolia for pain     management intervention (Treatment Group) was compared to placebo aromatherapy with jojoba     oil (Placebo Control Group) and to the current standard of care, which is no oil during a     venipuncture (Standard of Care Control Group). Primary measured outcomes were assessed using     a double-blind randomized design. The physiological measure of heart rate was taken over the     course of four minutes at three different intervals to note the pattern of change that occurs     during anticipatory anxiety resulting from the impending procedure, the procedural pain     experienced during the venipuncture, and the residual fear common after completion of the     venipuncture procedure. The Visual Analogue Scale (VAS) for pain and the Hospital Fears     Rating Scale (HFRS) were administered to measure subjective pain and anxiety. Participants     (N=21) were recruited from the Laboratory Medicine Unit of Children's National Health System.     Feasibility was estimated based on the ability to inhale the full dose of oil without adverse     effects and and ability to inhale the full dose within the ten-minute time frame. This study     analyzed the effect of the aromatherapy pain management intervention, lavandula angustifolia     aromatherapy, on the stress response of a pediatric population through observation of     physiological and psychological indicators of pain and distress, in order to learn more about     the pain and anxiety experienced during venipuncture and the use of aromatherapy to decrease     pain and anxiety during venipuncture.   "
12466|NCT03122561|"     Paracetamol is an antipyretic drug that is taken orally at different times of the day in same     dose. It is excreted mainly through renal route which may show diurnal variation. In this     study, urinary excretion of paracetamol of 41 healthy men of same age group will be measured     by HPLC after oral administration of 500 mg paracetamol tablet at morning, midday and night.     The measured values will be compared in order to adjust doses of oral paracetamol at     different times of the day.   "
12469|NCT03122522|"     This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is     sufficient for patients with early benefit compared to the usual way of trying to give 4     doses. If patients do not show early benefit after 2 doses, patients will be able to continue     with additional ipilimumab + nivolumab, even beyond the standard 4 doses if felt in the best     interest of the patient.   "
12470|NCT03122509|"     The purpose of this study is to test the safety and effectiveness of two investigational     drugs (drugs that are not currently approved by the FDA) given in combination with radiation     therapy or ablation.   "
12471|NCT03122496|"     The purpose of this study is to test the safety of durvalumab (MEDI4736) and tremelimumab in     combination with radiation therapy and find out what effects, if any, this combination has on     people, and whether it improves overall survival.   "
12472|NCT03122483|"     This multicenter prospective trial will evaluate the association between obstructive sleep     apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled     symptomatic patients with a clinical suspicion of OSA.   "
12473|NCT03122470|"     MRI is being increasingly relied upon for detection, staging and management of prostate     cancer. In this study patients with risk of prostate cancer will be recommended to have a     pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any     detected prostate cancer. The results of the MRI will be compared to standard diagnosis     techniques to see if cancer can be more accurately detected.   "
12474|NCT03122457|"     The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne.     Eligible women will be over the age of 18 and not on any current therapy. The patients will     first arrive for a screening visit, where they will be given questionnaires on acne quality     of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by     Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne     vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of     menses (as studies indicate that most women have their acne flare during this time). The     study team will perform a zit count (counting papules, pustules, and comedones) and global     assessment, and the patient will be instructed to record their menses (which they will do for     the duration of the study). The patients will then return in 2 weeks, at day 15, and they     will be re-assessed. The patients will be dispensed the investigational product and     instructed on its daily use. The patients will continue to return every 14 days to have their     skin assessed until their final visit on day 99, one week after their 3rd menses on treatment     (4th menses on study). The duration of the study per patient is approximately 4 months, and     the study team anticipates an enrollment period of 12 months.   "
12475|NCT03122444|"     Comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology     specimen or repeat core needle biopsy.   "
12476|NCT03122431|"     No drug treatment is completely free of risk and lack of response, adverse events and poor     adherence may affect its effectiveness. Within this context, this project aims to evaluate     the importance of monitoring blood levels and salivary drug used in rheumatic autoimmune     diseases in the monitoring of adherence to therapy. In addition, this project intends to use     the monitoring of drug levels, based on pharmacokinetic studies and     pharmacokinetics/pharmacodynamics modeling, to broaden the understanding of the possible     cellular, tissue and immunological mechanisms involved in efficacy and adverse effects of     these drugs with the prospect of reducing the damage and maintain therapeutic efficacy. The     high-performance liquid chromatography (HPLC) coupled to mass spectrometry, which will be     used to evaluate hydroxychloroquine, thalidomide, glucocorticoids, is considered the gold     standard technology to qualitative and quantitative analysis of drugs in blood and its     comparison with the dosage in the saliva is an improvement in simplification of the process.     For biological agents the focus will be on the understanding the loss of efficacy and the     possible role of anti-TNF antibodies using ELISA capture methodology.This project will be     divided into four sections with their respective sub-projects according to the medications     that will be studied: hydroxychloroquine, thalidomide, biologic agents and glucocorticoids.   "
12479|NCT03121456|"     Open-label, multicenter, uncontrolled and non-randomized study comparing 18F-FDG PET-Scan and     diffusion MRI in the assessment of the early therapeutic response of Diffuse Large B-Cell     Lymphoma.   "
41552|NCT02741739|"     Primary Objective: Determine blood concentrations of two formulations of REGN1033.      Secondary Objective: Assess safety and tolerability of REGN1033.   "
12482|NCT03121417|"     This phase II trial is studying blood and tumor tissue from patients with advanced non-small     cell lung cancer who are treated with nivolumab to better understand how nivolumab works.     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to     grow and spread by turning on the immune system (T cells). We want to study the effects of     nivolumab on the immune system (T cells) by collecting blood samples and samples from     patients' tumors.   "
12483|NCT03121404|"     Cirrhosis is characterized by loss of muscle as well as fat mass, which increases morbidity     and mortality before, during, and after liver transplantation. A common mechanism for the     reduced muscle and fat mass in cirrhosis is an increased expression of the TGF (transforming     growth factor)beta superfamily member, myostatin, in the muscle and adipose tissue. The     present study will examine the expression of myostatin, its receptor and intracellular     signaling pathways in the skeletal muscle and mesenteric adipose tissue in cirrhotic patients     undergoing liver transplantation as compared to healthy controls undergoing planned abdominal     surgery. 16 cirrhotic patients will be identified from the transplant list, and 16 healthy     controls from outpatient surgery lists. Nutritional assessment will be performed, including     anthropometry (triceps skinfold thickness, mid arm circumference), dual energy x-ray     absorptiometry (DEXA), and bioelectrical impedance analysis (BIA). Rectus abdominis muscle     tissue and omental fat tissue will be harvested in the operating room, and the expression of     signaling proteins involved in skeletal muscle protein synthesis will be quantified. The     investigator will also quantify the expression of genes involved in lipolysis and lipid     synthesis. The investigator anticipates that the expression of myostatin will be higher in     the skeletal muscle and adipose tissue of cirrhotics as compared to controls. There will be a     reduction in the expression of the signaling proteins that regulate skeletal muscle protein     synthesis, as well as the expression of genes regulating lipogenesis. The increased     expression of myostatin will also correlate with reduced anthropometric and DEXA measurements     of lean body mass and fat mass.   "
12484|NCT03121391|"     The proposed study is an important, under-investigated area of ICU care for terminally ill     patients undergoing terminal ventilator withdrawal. The proposed research has relevance to     public health because an algorithmic approach to the ventilator withdrawal process will     enhance clinicians' ability to conduct the process while assuring patient comfort, using     opioids and/or benzodiazepines effectively.   "
12485|NCT03121378|"     The aim of the study is to assess blood platelet function and activation in patients     undergoing both cement and non cement hip joint total alloplasty. Bone cement is used as a     special biomaterial to help fix a hip prosthesis in place but is associated with bone cement     implantation syndrome causing such complications as hypotension, cardiac arrhythmias. The     pathophysiology of bone cement implantation syndrome is not fully known but one theory     supports formation of clots in the bloodstream. This directly would activate platelets but no     such study has been performed in humans. As bone reaming could potentially cause platelet     activation even without bone cement, the study involves a control group of patients     undergoing non cemented joint alloplasty.   "
12486|NCT03122392|"     he idea of the experiment is to calculate the volume of fluid that is required to raise cuff     pressure from 20 cmH2O to 120 cmH2O in the American Medical System's AMS 800 Artificial     Urinary Sphincter (AUS).   "
12487|NCT03122366|"     Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptor-4     (TLR4) in particular, appears to play a role in susceptibility to cancer. Of 44 identified     SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at     nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads     to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene. Pre-clinical     studies from our laboratory have shown an association of TLR4 with ultraviolet radiation     induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms     and susceptibility to skin cancer.   "
12488|NCT03122353|"     This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation     of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to     the RLD.   "
12489|NCT03122340|"     The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in     patients with acute coronary syndrome   "
12490|NCT03122327|"     This is a multi-center, prospective, non-interventional study. Eligible newly diagnosed     elderly multiple myeloma (MM) patients will receive comprehensive geriatric assessment (cGA)     including ECOG scale, questionaires of ADL（activities of daily living), IADL(instrumental     ADL),MNA-SF(mini-nutritional assessment), GDS(geriatric depression scale), MMSE(mini-mental     state examination), SF-36 and CCI (charlson comorbidity index). Patients will get standard     care for MM and receive the above assessments at baseline and after cycle 1, 4 and 12 for     treating MM.Follow-up information and survival data of these MM patients would be collected.     We would evaluate the cGA status of these newly diagnosed elderly MM patients and investigate     the association of cGA parameters with patient's survival.   "
12491|NCT03122314|"     -  Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by          emergency physicians in Turkey for the treatment of patients with acute non traumatic          musculoskeletal pain.        -  The objective of the study is compare the efficacy of intravenous dexketoprofen with          paracetamol in the treatment of acute non-traumatic musculoskeletal pain.   "
12492|NCT03122301|"     Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer     survivors and negatively impact their quality of life. VMS in Hispanic women are     significantly more severe as compared to non-Hispanic Caucasian women. Few effective     treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking     populations which is problematic, as Hispanics will comprise 20% of the U.S. population by     2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for     chronic pain indications, has shown promise as a potential treatment for menopausal women     with VMS in previous clinical trials, but has not been investigated in Hispanic or     Spanish-Speaking women with breast cancer in a controlled study.   "
12608|NCT03120442|"     Postoperative delirium after total knee replacement surgery has been related to significant     morbidity and mortality among high risk patients. Anesthetic care might play a role in the     development of postoperative delirium.      The purpose of this study is to compare the incidence of postoperative delirium between     different intraoperative sedation regimen. Delirium assessment using standardized screening     tools will be done every 8 hours after surgery.   "
12502|NCT03122171|"     The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in     improving the upper extremity function of children with cerebral palsy who have limited use     of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in     their ability to use their hands, will be enrolled. All participants will be fitted with a 3D     printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be     evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The     evaluation will include assessment of (1)passive and active arm/hand movement and     (2)functional hand skills using several standardized tests. The results from the     pre-treatment and the two post-treatment evaluations will be compared.   "
12493|NCT03122288|"     Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND)     which represents a significant symptom that interferes with everyday functioning and quality     of life. As adults age with HIV, they are more likely to develop comorbidities such as     cardiovascular disease, hypertension, and insulin resistance which will further contribute to     poorer cognitive functioning and HAND. Based upon the Frascati criteria, HAND is diagnosed     when a person performs less than 1 to 2 SD below their normative mean (education & age) on     measures of two or more cognitive domains (e.g., attention, speed of processing, verbal     memory, executive functioning). Yet, from the cognitive literature and prior studies,     administering certain computerized cognitive training programs may improve specific cognitive     domains in older adults and those with HIV. Such cognitive training programs may be effective     in older adults with HIV and therefore investigators may be able to change the diagnosis of     HAND in such cognitively vulnerable adults. In this pre-post experimental study, 146 older     adults (50+) with HAND will be randomized to be in either: 1) the Individualied-Targeted     Cognitive Training, or 2) a no-contact control group. The investigators will focus on those     cognitive domains in which participants express an impairment and train them with the     corresponding cognitive program. Such an Individualized-Targeted Cognitive Training approach     using standard cognitive training programs may offer hope and symptom relief to those     individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday     functioning (e.g., IADLs) and quality of life. This approach represents a paradigm shift in     possibly changing the way HAND is examined. Specific Aim 1: Compare adults who do receive     Individualized-Targeted Cognitive Training to those who do not in order to determine whether     a change in HAND prevalence and severity occurs between groups. Exploratory Aim 1: Compare     adults who do receive individualized-targeted cognitive training to those who do not in order     to determine whether this improves everyday functioning (e.g., IADLs). Exploratory Aim 2:     Determine whether improvements in HAND and/or everyday functioning over time mediate     improvements in quality of life.   "
12494|NCT03122275|"     This study aims to assess the effectiveness of a stepwise approach, with increasing     complexity and cost, to improve adherence to organized cervical cancer screening: step 1a -     customized text message invitation; step 1b - customized automatic phone call invitation;     step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.      A population-based randomized controlled trial will be implemented in Portuguese urban and     rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to     intervention and control. In the intervention group, women will be invited for screening     through text messages, automatic phone calls, manual phone calls and health professional     appointments, to be applied sequentially to participants remaining non-adherent after each     step. Control will be the standard of care (invitation by written letter).      As primary objectives, we intend to test the superiority of interventions based on step 1     (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on     intention-to-treat analyses.   "
12495|NCT03122262|"     This is a non-inferiority (10% non-inferiority margin), study to assess the efficacy and     safety of dolutegravir, DTG (50 mg once daily [QD]) administered in combination with     tenofovir alafenamide fumarate, TAF (25 mg QD) and emtricitabine, FTC (200 mg QD) compared to     DTG (50 mg QD) administered in combination with tenofovir disoproxil fumarate, TDF (300 mg     QD) and FTC (200 mg QD) and compared to efavirenz, EFV (600 mg QD) administered in     combination with TDF (300 mg QD) and FTC (200 mg QD) over 96 weeks in patients with HIV-1     starting first-line ART.   "
12496|NCT03122249|"     Nearly 20% of Americans and 41% of Iowans live in rural or non-metropolitan areas.(1) Lack of     access to providers, long travel distances, and a disconnected health system contribute to     increased distress and lower quality-of-life (QOL) in people with advanced cancer living in     rural areas. (2) In the state of Iowa, 94% of rural residents have high-speed internet     access. (3) The University of Iowa Health Care (UIHC) eHealth eNovation Center has developed     the infrastructure to address the health care access gap in Iowa. The combination of wide     availability of high-speed internet and the eHealth network provides an opportunity to     develop and test interventions that leverage this infrastructure in order to address this     important palliative care gap.      This is a pilot study to evaluate the feasibility of an eHealth self-management intervention     for cancer symptom management. The intervention consists of a web-application that provides     tailored educational information about cancer symptoms and a monitoring platform to track     symptom distress and strategies used to manage them. Participants will also receive e-visits     from a research nurse or research assistant via UIHC eHealth and eNovation video platform.     The purpose of this study is obtain feasibility data about the intervention for a future RCT     and to evaluate the OASIS intervention with patients living in rural Iowa receiving treatment     for advanced cancer. The specific aims are:        1. to evaluate the feasibility of the OASIS intervention to self-manage symptoms of rural          patients with advanced cancer, including a) recruitment and retention, b) use patterns,          c) usability of each component of the intervention (i.e., the e-visit platform and the          web-application), d) acceptability of the intervention and study (i.e., satisfaction,          barriers and facilitators to use, burden); and        2. to determine preliminary effects of the intervention on self-management behaviors and          symptom severity, symptom distress, and symptom interference.   "
12497|NCT03122236|"     Loss of mobility and cognitive ability are serious conditions that threaten the independence     of older adults. The objective of this study is to initiate a line of research to develop a     novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of     frontal/executive circuits.   "
12498|NCT03122223|"     A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438)     and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult     participants   "
12499|NCT03122210|"     Hypoxemia is a common problem encountered during acute coronary syndrome. During acute     coronary syndrome, the American College of Cardiology and the American Heart Association     recommend oxygen delivery to patients with less than 90% oxygen saturation. Oxygen therapy in     these patients for a duration of at least 6 hours , but also stipulates that it is reasonable     to administer oxygen to all acute coronary syndrome patients during the first six hours     Following the presentation. However, the studies underlying these guidelines are few and far     between, most of them having been done more than forty years ago.      Hyperoxia also has well-established risks.      Our research hypotheses are:      (I) that current practices tend to use high oxygen flows resulting in high SpO2 levels during     acute coronary syndrome.      (II) there is a high rate of desaturation in patients with acute coronary syndrome and an     automatic adaptation of oxygen flows may reduce this frequency. This will be our primary     endpoint and will be tested with the use of the automated oxygen delivery system.      (III) that excessive oxygenation targets have no advantage. Our hypothesis is that     maintaining a SpO2 of 91 to 95% is at least equivalent when compared to higher saturation     objectives (SpO2 of 94 to 100%) with regard to the occurrence of complications in the patient     in acute coronary syndrome . We will use two SpO2 targets with the FreeO2 system, 92 and 97%.   "
12500|NCT03122197|"     The purpose of this study is to determine the ability of letrozole to penetrate the blood     brain barrier and concentrate in gliomas.   "
12501|NCT03122184|"     This is a randomized controlled pilot trial in 50 acute coronary syndrome patients to     determine if a 12 week, telephone-delivered, combined positive psychology-motivational     interviewing intervention is more effective than a health behavior education program at     improving health behaviors and other outcomes. The investigators hypothesize that the     intervention will be associated with better mental and physical health outcomes and better     health behavior adherence compared to the health behavior education program.   "
12526|NCT03121859|"     Does the use of analgesic current therapies increase the effectiveness of neck stabilization     exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a     randomized, controlled, single-blind study   "
12503|NCT03122158|"     Escitalopram has been approved by FDA in the treatment of adolescents with major depressive     disorder since March 2009. To date, there are only 3 clinical trials assessing the effect and     validity of escitalopram on major depressive disorder, which of them has resulted in     inconsistent findings. In the present study, the authors aimed to assess the effect and     validity of this drug in the treatment of adolescents with major depressive disorder and or     anxiety disorders.   "
12504|NCT03122145|"     The purpose of this study is to establish normative values for clinical testing measures of     swallow, respiratory and cough functions. This will aide in establishing degree of impairment     in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.   "
12505|NCT03122132|"     The aim of the study is to evaluate in clinical practice the efficacy and safety of     ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve     participants with genotype 1b hepatitis C virus (HCV).   "
12506|NCT03122119|"     This prospective study will be quantitatively analyzing the effectiveness of     platelet-rich-plasma (PRP) injections into the sacroiliac (SI) joint as compared to     corticosteroid injections and conservative management in relieving sacroiliitis and low back     pain originating from the SI joint. The effectiveness of PRP injections on joint pain has     been well studied in the knee and shoulder. PRP injections are performed on the SI joint     commonly, but there is little research documenting their effectiveness when compared to other     interventions. This study will be a small pilot study to aid in closing this knowledge gap.     Additionally, these injections will be performed under ultrasound guidance. Ultrasound has     been proven to be of equal reliability to fluoroscopy and has the advantage of shorter time     to administer and no radiation. There will be three arms to this study. The first will be a     control arm, the second will be an active comparator arm which is the corticosteroid     injection, and the third is the experimental arm consisting of PRP injection. The     corticosteroid and PRP will be injected into the joint using the exact same technique via     physical exam, special tests, and ultrasound guidance. The only difference between the two     arms is the substance to be injected. The outcomes will be measured with the Numeric Rating     Scale for Pain (NRS) and the Oswestry Disability Index (ODI) prior to the injection,     immediately post-injection, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year     post-injection. The investigators hypothesis is, Platelet-Rich Plasma Injections in the     Sacroiliac Joint using ultrasonography in conjunction with physical examination and Point of     Maximal Tenderness will produce statistically significant pain relief for more than 3 months     as measured by the Numeric Rating Scale for Pain (NRS) and Oswestry Disability Index (ODI).   "
12507|NCT03122106|"     This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen     DNA vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant     chemotherapy. The neoantigen DNA vaccines will incorporate prioritized neoantigens and     personalized mesothelin epitopes and will be administered with an electroporation device. The     hypothesis of this study is that neoantigen DNA vaccines will be safe and capable of     generating measurable neoantigen-specific CD4 and CD8 T cell responses.   "
12508|NCT03122093|"     To the investigators' knowledge, no single long-term prospective observational study has     assessed dietary factors, diabetes clinical variables (metabolic control and associated     complications), and self -perceived health and wellness in T1D patients (both pediatric and     adult) with CD identified by screening (positive/weakly positive serology). The aim of the     current study is to observe the short- and long-term outcomes for Type 1 diabetic patients     with new serology positive asymptomatic CD.   "
12509|NCT03122080|"     The investigators describe a protocol for a multicenter randomized controlled trial to find     out the efficacy of electroacupuncture for depression related insomnia.   "
12510|NCT03122067|"     The aim of the present experiment is to examine oxytocin's behavioral and neural effects on     social pain empathy   "
12511|NCT03122054|"     This study examines complications, mortality rates, cost-effectiveness and safety of early     laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L     (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D     (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks     later) laparoscopic cholecystectomy.   "
12512|NCT03122041|"     Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion     of patients cannot tolerate it due to associated gastrointestinal adverse events. The     alternative pharmacological strategy when metformin cannot be tolerated is not well     established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves     metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.   "
12513|NCT03122028|"     The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM     Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or     permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal     and transthoracic echocardiography.      The conducted LA-EU-01 study was a prospective, non-randomized, multi-center, open-label,     non-comparative, interventional clinical investigation with the participation of two clinical     centers in Germany and the inclusion of 61 subjects.      Participating subjects were patients with non-valvular paroxymal, persistent or permanent     atrial fibrillation with long-term sustainability and scheduled for interventional closure of     the left atrial appendage who could not be treated with anticoagulation.      After the procedure of implantation of the LAmbreTM Left Atrial Appendage Closure System,     patients underwent a first follow up assessment prior to hospital discharge then at 30 days,     6 and 12 months.   "
12573|NCT03120858|"     Imagery is determined with two strategies to mentally simulate the movements: visual and     kinesthetic imagery. Visual motor imagery (VMI) is associated with spatial coordinates of a     movement in the environment and through this speciality VMI applies mainly to the imagery of     moving objects or to movement of another person in the imagined environment, although imagine     of own movement is also possible. Kinesthetic motor imagery depends on dynamic relationship     among the individual, the movement and the environment and it should be determined by the     nature of the task, the environment and individual characteristics and also requires feel     the movement.      The aim of this study is to translate this questionnaire into Turkish and the translation in     terms of its internal consistency, test-retest reliability.   "
12514|NCT03122015|"     Children in hospitals are frequently subjected to painful procedures, including those     involving needles, which are a common source of pain in children. In addition, procedural     pain and anxiety can lead to various consequences for the child, as well for the parent and     the nurse performing the procedure. The use of physical and psychological interventions is     recommended for optimal relief of procedural pain. Moreover, these interventions can be used     alone or in combination with pharmacological treatment. Although several analgesics exist and     are used in clinical practice, nonpharmacological interventions aimed at the psychological     component of pain are not well known and are not always used by the nurses in the pediatric     practice. Distracting interventions are widely studied in the literature as it is an     effective psychological intervention in the relief of pain and anxiety in children during     needle-related pain procedures. The distraction by the therapeutic clown is a multi-modal     intervention with multi-sensory effects and appears promising in pain relief and procedural     anxiety, but not much studies have been done in the context above. The therapeutic clown can     adapt to the age of the child, its culture, its reality of care and can prepare the child for     painful procedures. The aim of this study is to assess the feasibility, acceptability and     preliminary effects of distraction by therapeutic clown on pain and anxiety of children aged     two to 17 years and the level of anxiety of the parents and nurses during a painful procedure     in children.      OBJECTIFS AND QUESTIONS:        1. Assess the feasibility and acceptability of distraction by therapeutic clown with          children during painful procedures. a) Is the distraction intervention by the          therapeutic clown feasible and acceptable during painful procedures?        2. Assess the preliminary effects of distraction by therapeutic clown on pain and anxiety          of children and the anxiety of parents and nurses. a) What are the preliminary effects          of the therapy clown distraction on children's pain and anxiety, and the anxiety of          parents and nurse.   "
12527|NCT03121846|"     This is a Prospective, Open-label, Single-Arm, Multi-center phase II clinical trial     evaluating the efficacy and safety of Apatinib for Chemotherapy Failure Ⅳ Stage Soft Tissue     Sarcoma.   "
12528|NCT03121833|"     This is a randomized, double-blind, placebo-controlled (2: 1), multicenter clinical phase II     clinical trial evaluating the efficacy and safety of Endostar combined with chemotherapy for     stage IV soft tissue sarcoma.   "
12515|NCT03122002|"     Through 5 years continuous observation of acute ischemic stroke patients in Neurology     Department of Tongji Hospital, Tongji Medical College of Huazhong University of Science and     Technology, clinical data about emergency treatment (neurological score, examination and     treatment), medical data after admission (neurological score, inspection, examination and     treatment) and long-term prognosis (neurological score) was collected. The outcomes were set     as the score scale, all blood test index and examination index of the research objects at     specific period after illness. Through statistical analysis and comparison of different     in-hospital clinical data in predicting the outcome of the patients, our study will provide     more evidence-based solutions for the treatment and prediction of acute ischemic stroke.   "
12516|NCT03121989|"     Breast cancer is the second most common form of cancer in women and the most frequent cause     of death. Despite breast screening programs, a substantial number of women are diagnosed with     cancers greater than 2 cm in size or locally advanced disease, which is best treated with     neoadjuvant chemotherapy (NAC) prior to surgery. Approximately 10% of women diagnosed with     breast cancer annually will have locally advanced breast cancer, defined as stage III     disease, where the cancer has either spread to regional lymph nodes and/or other tissue in     the area of the breast, but not to distant sites. NAC offers the advantages of downstaging     the disease, potentially reducing the extent of surgery. Presently, gadolinium enhanced MRI     is the standard test used to monitor disease response to chemotherapy, and demonstrates     changes in tumour size and extent between pre-NAC and post-NAC. Unfortunately, changes in     tumour size may occur late in treatment regimen, thus producing false-negative results on     early magnetic resonance imaging (MRI). Therefore, newer imaging techniques beyond anatomical     imaging are needed to identify tumours that are unresponsive to chemotherapy and potentially     change treatment plan early on to avoid significant morbidity associated with prolonged     chemotherapy.      A novel MRI technique utilizing hyperpolarized pyruvate has the potential to detect     pathophysiological response early in the treatment regimen and would therefore allow for     earlier identification of nonresponders and subsequent early modification of treatment     regimens, if necessary.   "
12517|NCT03121976|"     The purpose of this study is to determine which technique for catheter placement in     continuous femoral nerve block (FNB) is most successful - guidance with (1) ultrasound or (2)     nerve stimulation and ultrasound. Sensory and motor assessment scores will be obtained     post-FNB. Patient controlled analgesia and opiate consumption is also recorded along with     pain scores for the first 48 hour post-FNB.   "
12518|NCT03121963|"     Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease     the use and risk of opioid pain medications as well as improve pain control in head and neck     surgery patients. Participants will be randomized to one of two pain regimens (opioid     medication regimen vs combination regimen of opioid and non-opioid medications).   "
12519|NCT03121950|"     The goal of the study is to learn about how possible benefits of movement and music for     individuals with dementia. Individuals with dementia will participate in either a dance class     or listen to live music. The study includes assessments of walking, balance and cognition.   "
12520|NCT03121937|"     This study aims to evaluate a technology-based treatment support system for patients     undergoing the treatment of depression. The investigators will explore the usefulness of the     technology-based treatment support system as an adjunct to psychotherapy for depression.   "
12521|NCT03121924|"     Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte     donation model.   "
12535|NCT03121742|"     Suicide is the most common form of deadly violence. Indeed, since more than 40,000 people die     by suicide each year, people are 2.5 times more likely to die by their own hand than someone     else's. The four weeks after discharge from inpatient care is an especially dangerous period     in terms of suicide risk, possibly because of poor post-discharge treatment adherence and     poor treatment efficacy during a suicide crisis. To reduce suicide risk both in general and     during the post-discharge period, interventions are needed that (1) are easily adhered to and     (2) are effective during a suicide crisis. The goal of the study is to pilot-test a suite of     five smartphone-based ecological momentary interventions (EMI) that can be easily used during     a suicide crisis. Two target hopelessness, two target loneliness, and one targets negative     automatic thoughts associated with hopelessness and loneliness. Although these interventions     are new to the study of suicide, they are all grounded in decades of empirical work and     adapted from effective interventions in areas relating to suicide.      Participants will be 20 inpatients (n = 10 each in treatment as usual [TAU] plus intervention     and TAU plus assessment [i.e., control] groups) from the Massachusetts General Hospital     Inpatient Psychiatric Service. The investigators hypothesize that those in the TAU plus     intervention group will have lower levels of suicidal ideation during the inpatient and     post-discharge period than those in the TAU plus assessment group.   "
12536|NCT03121729|"     This study is aimed to evaluate the safety of applying enhanced recovery after surgery for     gastric cancer.   "
12522|NCT03121911|"     Introduction: Expiratory flow limitation (EFL) and ventilatory inefficiency during dynamic     exercise have been identified in patients with recent myocardial infarction (RMI) with     preserved ventricular and pulmonary function. However, it is not known what is the prevalence     of EFL in this population and what are the effects of physical and respiratory training on     this limitation.      Objectives: To evaluate the prevalence of EFL and ventilatory inefficiency during dynamic     exercise in individuals with uncomplicated RMI, and to evaluate the effects of interval     physical training (IT) in addition to inspiratory muscle training (IMT), exclusive IT and     absence of cardiopulmonary rehabilitation (CR) on EFL and ventilatory efficiency.      Methods: 54 patients will be included, divided into three groups with 18 participants each.     All will be submitted to evaluations of heart rate variability, hematological and biochemical     profile, erythrocytes membrane deformability and stability, inflammatory markers, respiratory     pressures, plethysmography, spirometry, carbon monoxide diffusion capacity, ankle brachial     index, electrical bioimpedance, echocardiogram, quality of life questionnaires,     cardiopulmonary exercise testing and constant load tests. Then, groups 1 (IT) and group 2 (IT     + IMT) will participate in a physical training program for 12 weeks and will be re-evaluated     after this period. In addition, they will be monitored for a 6 month period after discharge,     with returns every two months to measure the energy expenditure through an accelerometer, and     at the end of this period they will repeat all the tests again. Group 3 (absence of CR), will     consist of patients who do not live in the city or those who can not participate in the CR     program for any other reason, and will only participate in the evaluations.   "
12523|NCT03121898|"     Prospective cohort study on adult cardiac surgery patients. Platelet function evaluated     before and after cardiopulmonary bypass. Bleeding and transfusion recorded. Primary endpoint     is finding the association between postoperative platelet function and bleeding.   "
12524|NCT03121885|"     The aim is to define in detail metabolic pathways at rest and during aerobic exercise in     normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions,     using metabolomics technologies based on minimally invasive sampling relying on gas     chromatography and mass spectrometry.   "
12525|NCT03121872|"     Objective: Titanium-prepared platelet-rich fibrin (T-PRF) is activated with titanium, which     results in a more mature and aggregated form than PRF. In our previous studies, we     established that the fibrin carpet formed with titanium had a firmer network structure, and     longer resorption time in the tissue than the fibrin carpet formed with glass. The purpose of     this randomized controlled clinical trial is to compare the effects of autogenous T-PRF and     CTG.      Materials and methods: A total 114 Miller Class I/II gingival recessions with abrasion     defects will be treated either T-PRF (63 teeth) or CTG (51 teeth) using a modified tunnel     technique. Clinical periodontal indexes, keratinized tissue (KTW), gingival thickness (GT)     and recession depth (RD) will be recorded before surgery and at 6 and 12-month follow-up     examinations. The Visual Analog Scale and healing index scores will be assessed.   "
12530|NCT03121807|"     This survey is a single arm study to assess the effect of home parenteral nutrition on     overall survival, cycles of salvage chemotherapy completed, side effects of salvage     chemotherapy, quality of life, nutritional status, functional status, inflammatory status and     complications of HPN in malnourished unresectable metastatic gastric cancer (mGC) patients in     a single medical center. It is expected that about 20 subjects will be recruited during an     estimated period of 48 months.   "
12531|NCT03121794|"     Evaluate whether discrete landmarks of the proximal humerus can be identified using     ultrasound in patients with various body habitus and BMI.   "
12532|NCT03121781|"     Preterm babies have immature lungs and frequent pauses in their breathing which often     necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of     the most commonly used tools, but the standard interfaces (prongs or mask) may cause     nasal-septal injury and discomfort.      The RAM cannula is another interface that consists in soft and curved prongs to avoid this     nasal injury, but as the seal is not 100%, suboptimal delivery of airway distending pressure     could result if they are used to deliver CPAP, as compared to standard interfaces.      The investigators plan to study very low birth weight preterm babies who are generally well     but require some support with their breathing. By inserting a special feeding tube with     sensors into the stomach, the investigators can measure the electrical activity of the     diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies     receiving nCPAP either with prongs or ram cannula, the investigators will be able to measure     and compare how each method of support affects a baby's breathing. This important study will     help us determine the most appropriate breathing support for preterm babies.   "
12533|NCT03121768|"     A prospective observational study to re-establish a new prognostic model for predicting the     outcome in patients with non-muscle invasive bladder cancer (NMIBC) using the current     recommendation regimen for intermediate and high risk groups and including all potential and     highly prognostic factors.   "
12534|NCT03121755|"     The type 1 cholecystokinin receptor (CCK1R) is a potential target for the treatment of     obesity, due to the ability of this GI hormone to elicit satiety. However, this receptor has     been shown to be sensitive to the cholesterol content of the membrane in which it is     expressed. Because some patients who might be candidates for the use of CCK agonists to treat     their obesity and co-morbidities, the goal of this study is to determine how metabolic     abnormalities might affect the responsiveness of this receptor to CCK. Because the normal     site mediating CCK-stimulated satiety is on vagal afferent neurons that cannot easily be     studied, we will collect buffy coat cells from a peripheral blood sample from patients     involved in the Sangre Por Salud Biobank at Mountain Park Medical Center. Ex vivo, the CCK1R     will be expressed on these cells and will be functionally characterized, and the cholesterol     content of the cells will be assayed. These data will be correlated with the clinical,     biochemical, and metabolic phenotypic data collected as part of the parent study.   "
12537|NCT03121716|"     This is an open-label, single center, non-randomized, phase I trial to evaluate safety and     efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by     recurrent and metastatic NPC.   "
12574|NCT03120845|"     Aim :to compare incidence of post-operative pain and apical healing after single-visit versus     two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.   "
12538|NCT03121703|"     Purpose: The purpose of this study is to investigate the effects of lumbar stabilization     exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity,     functional disability, and TrA thickness in patients with chronic low back pain (CLBP).     Subjects: The subjects of this study were 30 CLBP patients. Methods: The experimental group     performed diverse lumbar stabilization exercises in different postures, and the control group     conducted an ordinary trunk muscle strengthening exercise. Results: There were significant     differences in pain intensity, TrA activation capacity, functional disability, and TrA     thickness between before and after the intervention in both groups. Significant differences     between the two groups were shown in the pain intensity, TrA activation capacity, and     functional disability after the intervention. However, there were no significant differences     between the two groups in TrA thickness. Conclusion: Lumbar stabilization exercises in     different postures could reduce pain, functional disability, and increase TrA activation     capacity and thickness in CLBP patients.   "
12539|NCT03121690|"     Cross sectional randomized clinical trial study will be done at Respiratory intensive care     unit and Chest department at Assiut University Hospitals on All patients who developed     hospital acquired pneumonia including ventilator associated pneumonia through two years     duration to assess the prognostic value of different severity scores including (PSI, CURB65,     SMART COP, IDSA/ATS and SOAR) in patients with HAP, assess platelet count as a marker for     severity, evaluate efficacy and safety of adjuvant systemic steroids in patients with severe     conditions and measurement of cortisol level to assess steroid response before     administration.   "
15288|NCT03085355|"     The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the     association of the osteopathic manipulative treatment in individuals with chronic     non-specific neck pain who receive a exercice program and pain neurocience education.   "
12540|NCT03121677|"     Follicular lymphoma (FL) has a number of effective standard of care therapies; however, FL is     not currently considered curable. Therefore, designing well tolerated therapies without     cumulative and long-term toxicity is critical. This is a pilot safety and feasibility study     that combines a personalized synthetic long peptide vaccine with nivolumab for the treatment     of FL. Patients who demonstrate progression on this study will be treated with rituximab (or     another monoclonal antibody against CD20) in addition to vaccine therapy with nivolumab.   "
12541|NCT03121664|"     The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on     plasma concentration of PF-06649751 in healthy subjects   "
12542|NCT03121651|"     This is a pilot study to develop a reinforcement learning (RL)-adaptive visual and     interactive support application (hereafter RL-adaptive support) to help young adults with     spina bifida or cerebral palsy become more independent with medication management.     Individuals with disabilities who are empowered to manage several aspects of their lives can     ultimately be better integrated into and contribute more to society.   "
12543|NCT03121638|"     -  Indication: Protection against varicella and herpes zoster        -  Study Objectives             -  Primary: Safety and tolerability assessment after single dose administration of               NBP608             -  Secondary: immunogenicity assessment after single dose administration of NBP608   "
12544|NCT03121625|"     This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of     chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and     lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2     years.   "
12545|NCT03121612|"     The study aims to assess the basic functionality of a newly designed CPAP machine with     reusable circuits to existing machines with disposable circuits, for treatment of newborn     infants diagnosed with respiratory distress syndrome. The assessment will compare a     comprehensive list of physiological parameters over the first 72 hours of treatment, and will     also monitor rates of side effects and adverse events. The null hypothesis is that infants     treated on the two categories of machine (reusable vs disposable) will not differ in relation     to key physiological parameters by more than 0.63 standard deviations.   "
12546|NCT03121248|"     This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT)     in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as     locally-advanced stage breast cancer.      Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary     endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL     and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for     radiation induced plexopathy.   "
12547|NCT03121235|"     A standard treatment protocol for invasive aspergillosis (IA) will be implemented in several     academic hematology centers in the Netherlands in which a diagnostic test demonstrating azole     resistance by multiplex real-time polymerase chain reaction will guide the choice of     appropriate antifungal treatment.      Objectives:        1. Improve the outcome of patients infected with azole resistant A. fumigatus by the early          detection of Resistance Associated Mutations (RAMs) and with this the earlier initiation          of the most appropriate therapy.        2. Monitor the prevalence of invasive aspergillosis due to strains carrying the TR34/L98H          or the TR46/T289A/Y121F resistance associated mutations in the Netherlands.   "
12548|NCT03121222|"     The main objective of the present study was to investigate whether N-acetylcysteine     supplementation in individuals with low glutathione levels would confer ergogenic effects by     replenishing glutathione levels and by reducing oxidative stress. Towards this aim,     investigators sought to exploit the large inter-individual variability in redox biomarker     levels. More specifically, investigators screened 100 male participants for glutathione     baseline levels in blood and formed three stratified groups according to this value (i.e.,     low, moderate and high; 12 individuals per group). After by-passing the regression to the     mean artefact by performing a second glutathione measurement in the three aforementioned     groups, investigators assessed both aerobic and anaerobic physical performance in order to     acquire a more comprehensive view about the ergogenic effectiveness of the antioxidant     treatment. This was accomplished by implementing three different whole-body physical     performance tests (i.e., VO2max test, time trial and Wingate), as opposed to most in vivo     studies that either applied isolated body-part exercise tests (e.g., by isokinetic     dynamometry) or performed a single exercise test (e.g., time-to-fatigue test). It was     hypothesised, that data of the present investigation will bridge the chasm between the     scientific (i.e., chronic antioxidant supplementation blunts exercise performance and     adaptations) and the community-based (i.e., free radicals should anyway be counteracted by     protective exogenous antioxidants) truths about the role of antioxidants as ergogenic aids.     It was also hypothesised that the results will show that low glutathione levels are linked to     decreased aerobic and anaerobic physical performance accompanied by increased levels of     oxidative stress and that N-acetylcysteine supplementation will restore both performance and     redox homeostasis. Based on the findings of the present investigation, the widespread routine     practice of consuming antioxidants during exercise training could be changed and the     consumption of antioxidants would be restricted only for those who are deficient in     glutathione.   "
12549|NCT03121209|"     We aim to determine whether cognitive impairment attributable to cerebral hemodynamic     impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible     with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored     CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with     asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy     plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery     stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death).      CREST-H addresses the intriguing question of whether cognitive impairment can be reversed     when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired     subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of     whom receive cognitive assessments at baseline and yearly thereafter. We anticipate     identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI     perfusion time to peak (TTP) delay on the side of stenosis. Among those who are found to be     hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at     baseline and at 1 year will determine if those with flow failure who are randomized to a     revascularization arm in CREST-2 will have better cognitive outcomes than those in the     medical-only arm compared with this treatment difference for those who have no flow failure.      We hypothesize that hemodynamically significant asymptomatic carotid disease may represent     one of the few examples of treatable causes of cognitive impairment. If cognitive decline can     be reversed in these patients, then we will have established a new indication for carotid     revascularization independent of the risk of recurrent stroke.   "
15297|NCT03085238|"     M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs).     It is intended for use in advanced-stage ovarian cancer patients. The study objective is to     assess the safety and the performance of the M-Trap device.   "
12550|NCT03121196|"     Social deprivation during pregnancy is associated to adverse perinatal outcomes. However,     prenatal screening of social deprivation by reliable measurement is not performed. Prevalence     of social deprivation is yet underestimated during pregnancy and vulnerable women are not     being provided optimal prenatal care.      Our aim is to validate EPICES score during pregnancy.   "
12551|NCT03121183|"     The growing use and the expanding indications for cardiovascular implantable electronic     devices (CIEDs) have been associated to an increase of device removal. The indications of     CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices,     nonfunctional devices and thrombosis. Removal can be performed according to transvenous or     surgical procedures. Transvenous lead removal (TLR) must be done by experimented     cardiologists and respecting current consensus. TLR can be done with conventional techniques     involving inserting locking stylets and telescoping sheaths around the pacing leads to     separate them from the surrounding scar tissue. These conventional procedures have a success     rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate     until >95%. However, the TLR from chronically implanted CIEDs still carries a significant     risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels     and cardiac structures, even when performed by experienced operators. Even if the transvenous     extraction using laser sheath seems to be more effective, this strategy would be more     expensive.      Considering the availability of several strategies for TLR and the cost heterogeneity of     procedures, a cost assessment in real life of these therapeutic strategies is essential for     an optimal choice of therapeutic strategies.   "
12552|NCT03121170|"     Primary dysmenorrhea (PD) is a common female disease during menstruating. Although     nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about side     effects. Alternative therapies, including acupuncture and moxibustion, are commonly used for     PD. Nevertheless, traditional Chinese medicine takes longer period than Western medicine to     release PD. Extracorporeal shock wave therapy (ESWT) originally for the treatment of     musculoskeletal diseases has characteristics of fast curative effect and no wound. Currently     there is no report about clinical use of ESWT for the treatment of PD. Our study is to     determine whether ESWT is effective in the treatment of PD based on meridian theory of     traditional Chinese medicine. The investigators hypothesis that ESWT during PD is more     effective than ESWT before PD or abdominal hot paste during PD without ESWT.   "
12553|NCT03121157|"     The purpose of the Detroit Young Adult Asthma Project is to test a technology based program     to help African American young adults learn to better manage their asthma. Participants will     be randomized to a multi-component technology-based intervention (MCTI) targeting asthma     medication adherence or to a comparison control condition.   "
12554|NCT03121131|"     The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite     physicians' growing reliance on radiological assessments, however, the reliability and     accuracy of reads are highly variable. Inconsistencies may result from multiple factors.      The researchers hypothesize that the presence and quality of clinical information will affect     radiologist's assessment of CT scans for the presence/absence of a ventral hernia.   "
12561|NCT03121040|"     ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then     followed by the generation of lactic acid. However, this process can only be maintained for a     short time, approximately one minute, because the accumulation of lactic acid in the muscles     may affect muscle performance. The efficiency of lactic acid metabolism is one of the most     important reasons for endurance improvement. The purpose of this study was to evaluate the     impacts of the daily ingestion of a commercially available Vespa amino acid mixture (VAAM®)     beverage on blood parameters that are related to fatigue, muscle damage and immunity in     healthy, young athletes during middle-distance running exercises. VAAM® contains 17 types of     amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive     required speed and strength running tests.   "
12575|NCT03120832|"     This is a Phase I, open-label, parallel design study of PAN-301-1, a HAAH directed     nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed     prostate cancer, using a fixed dose escalation schema every 21 days.   "
12576|NCT03120819|"     Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with     exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a     recommendation alone may not be enough to change behavior. Our study will determine whether     adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes     than a recommendation alone.   "
12555|NCT03121118|"     Diagnostic tests designed to detect Alzheimer's disease (AD) pathology are increasingly     popular in research on cognitive aging and AD. Due to concerns that information from such     tests may be misunderstood, psychologically harmful, and of unclear clinical significance,     results of pre mortem tests of AD pathology have typically been withheld from research     participants. However, as the reliability and potential clinical significance of tests like     brain amyloid imaging have become clear, there is a pressing need to revisit the practice of     unilaterally withholding such information from research participants and identify responsible     approaches to communicating individual results. Amyloid imaging results may be particularly     relevant to mild cognitive impairment (MCI), a population for whom a growing body of evidence     suggests that such testing may provide valuable prognostic and planning information, despite     the unavailability of interventions to alter one's clinical course. Our preliminary work     suggests that research participants with MCI and their family members are receptive to and     capable of understanding information about the purpose, results, and implications of amyloid     imaging when presented using a standardized approach developed by our interdisciplinary team.     Building on this work, the proposed study will examine a well characterized sample of MCI     care dyads (patient + family member) who will be randomized to either receive the opportunity     to decide if they would like to pursue an amyloid PET Scan, or be randomized to not receive     that opportunity (and will serve in the no-scan comparison group). This study aims to test     hypotheses that examine how receiving amyloid imaging results will impact understanding of,     and perceived self-efficacy for coping with, MCI among both patients and care partners.   "
12556|NCT03121105|"     Our objective is to describe the pathologic and MRI findings in a series of patients with     presumed demyelinating lesion of the central nervous system.   "
12557|NCT03121092|"     Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's)     are commonly used anti-hypertensive medications that may have implications on the management     of a patient undergoing surgery. Limited research has looked at the effects of these     medications on perioperative complications and mortality. Some studies conducted on small     groups of inpatients with advanced vascular disease undergoing vascular surgery or coronary     artery bypass grafting (CABG), suggest exacerbation of hypotension (low blood pressure) in     patients who continued taking ACEI's or ARB's on the morning of their procedure. In addition,     cases of low blood pressure (BP) that were refractory to standard treatment were reported.     One recent retrospective study reported no difference in severe hypotension and only a modest     difference in moderate hypotension managed by conventional treatment, but did not adequately     address the risk of preoperative hypertension. A study recently published by the     investigators (Twersky et al., 2014) in over 600 patients demonstrated no difference in     preoperative hypertension in ambulatory surgery and same day admission patients. There has     been limited data stratifying the degree of low BP based on severity but these were not done     in ambulatory patients, and neither was the degree of high BP from discontinuing these     medications addressed. As such, no uniform consensus has been reached and clinicians are     unclear as to whether the reported inpatient findings are applicable to the outpatients,     since they differ in many respects. The investigators propose to evaluate whether ACEI's and     ARB's discontinued preoperatively have a negative impact on perioperative hemodynamics and     patient outcome in a group of ambulatory and same day surgical patients. Similar to studies     done on inpatients, the investigators will also evaluate patients receiving a standardized     general anesthetic for hemodynamics following induction of anesthesia until surgical     incision.      The investigators hypothesize that continuing ACEI's and ARB's in the preoperative period     does not result in an increased risk of severe hypotension (low blood pressure) following     induction of general anesthesia.   "
12624|NCT03120234|"     This study has been planned to compare the effect of opioid free anaesthesia using     dexmedetomidine and ketamine with opioid based anaesthesia using fentanyl in maintaining the     intraoperative hemodynamic stability and recovery characteristics in patients undergoing     Transsphenoidal surgery of pituitary tumors.   "
12558|NCT03121079|"     Allogeneic stem cell transplantation (SCT) remains a powerful therapeutic modality for     patients with acute myeloid leukemia (AML).The superior clinical outcomes of allogeneic human     SCT versus chemotherapy alone as post-remission treatment could be related to the     graft-versus-leukemia (GVL) effects of recovered donor T cells. Our previous study     investigated both the association of MRD status with transplant outcomes in haplo-SCT and     matched sibling donor transplantation(MSDT)， and also possible differences in the transplant     outcomes of patients with positive pre-MRD (as determined by MFC) who underwent haplo-SCT     versus MSDT. It provided new evidence that unmanipulated haplo-SCT is superior to matched     sibling donor transplantation in eradicating pre-transplantation MRD, indicating that     unmanipulated haploidentical allografts have stronger GVL effects.As to the AML patients in     standard-risk, who have a positive MRD before MSDT, whether these patients should be given     any relapse prevention is the question to be answered in this study. Interferon α-2b exerts a     relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or     natural killer cell functions.Consequently, interferon α-2b may have potential value for     high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b     following hematopoietic stem cell transplantation in patients with standard-risk AML can     further reduce relapse rate and improve leukemia-free survival.   "
12559|NCT03121066|"     Background: Alzheimer's disease is a major health problem in our society. To date,     pharmacological treatments to reduce Alzheimer's disease symptoms have obtained poor results     and there is a growing interest in finding non-pharmacological treatments for this impactful     disease. Transcranial Magnetic Stimulation is a non-invasive tool which can induce changes in     brain activity and long term modifications of impaired neural networks, and therefore holds     promise as a clinical intervention.      Our overall goal is to study the benefit of targeting Transcranial Magnetic Stimulation based     on the individual's unique functional connectivity (personalized targeting) instead of     current non-individualized approaches. Specifically, the intermittent Theta Burst protocol     will be used and changes in cognitive, functional, and emotional deficits in these patients     will be evaluated. Functional brain connectivity changes induced by the TMS treatment will be     also assessed.      Methods: A double blind randomized controlled trial will be conducted to assess the effects     of TMS treatment immediately, one month, three months and six months after the end of the     treatment in comparison to the baseline measurements. Forty-five patients with a diagnosis of     Alzheimer's disease, will be randomly allocated (1:1:1) into experimental (active     Transcranial Magnetic Stimulation), sham control group, or conventional intervention control     group. Neuropsychological, functional, and emotional assessment will be conducted, as well as     functional connectivity measures, in order to assess the effectiveness of the treatment.      Discussion: The investigators expect to demonstrate that personalized Transcranial Magnetic     Stimulation intervention has measurable positive impact in cognitive and emotional     functioning, functionality, and brain connectivity, thus representing a potential treatment     for Alzheimer's disease.   "
12560|NCT03121053|"     Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients     undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are     easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast     induced nephropathy (CIN) has not yet been studied in these patients, and evidence on     different strategies is urgently needed. The objective of this study is to evaluate the     efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride)     hydration prior to TAVI in patients with CKD to prevent CIN.   "
12610|NCT03120416|"     The investigators aim to evaluate the feasibility of a resistance exercise training program     among individuals with CKD and its impact on endothelial and vascular function.   "
12562|NCT03121027|"     Despite significant advances in the field of medicine and healthcare, anemia continues to be     a major public health problem worldwide. The situation is particularly acute in developing     countries where females belonging to the reproductive age category are especially vulnerable     to the malady. Given the multifactorial nature of this disease, correcting anemia often     requires the adoption of an integrated approach. Therefore, it is imperative that the role     played by the causes of the causes (i.e., the sociodemographic determinants of risk), along     with other contributing factors, must be identified, and addressed in order to effectively     combat this disease. In general, it is terrible to sort out the psychosocial factors from the     demographics, environmental and poverty-related causes. Therefore, the objective of this     study is to use a nationwide representative survey to explore the magnitude of household     economic inequalities contribute towards the prevalence of anemia among ever-married women in     Bangladesh. The study also aims to examine the inference of other explanatory variables that     frequently had supposed decomposing on the burden of anemia. Thus, this study answers the     questions: (a) what are the strengths and likelihoods of having mild, moderate or severe     anemia among the ever married women of different SES?; (b) do other factors viz.,     demographics, diabetes, maternity, and BMI affects the strength and form of the association     between SES and anemia?; (c) which explanatory variable is more prone to pose anemia among     the women? As the burden of anemia is one of the key policy issues facing Bangladesh, the     findings generated by this study are expected to contribute towards further policy making by     virtue of identifying associated risk factors. This is expected to be instrumental for     program purposes designed to prevent anemia among Bangladeshi women.   "
12563|NCT03121014|"     The study is a Phase II clinical trial. Patients will receive intensity modulated total     marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v.     targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant     (HSCT).   "
12564|NCT03121001|"     The study is a Phase II clinical trial. Patients will receive intensity modulated total body     irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v. cyclophosphamide     conditioning prior to human leukocyte antigen (HLA)-haploidentical hematopoietic stem cell     transplant (HSCT).      The primary objective of the study is to determine the engraftment at Day +60 following     HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents     and low-dose total body irradiation (TBI) for conditioning and post-transplant     cyclophosphamide in patients with sickle cell disease.   "
12565|NCT03120988|"     The purpose of this study is to understand how the components of osteoarthritic knee joint     fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally,     the study participants will complete outcome questionnaire surveys before and after the     treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks     after lavage). This data will help determine if the treatment of an osteoarthritic knee joint     with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by     preparing a patient's knee for further regenerative therapies.   "
15298|NCT03085225|"     A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in     locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.   "
12566|NCT03120975|"     Prescribing antibiotics frequently poses problems in practice, since patients don't always     receive the right dosage of the right antibiotic for the right period of time. This promotes     the emergence and spread of antibiotic resistance. The investigators of this trial aim to     develop a system designed to help doctors to use antibiotics more appropriately. Under     COMPASS (COMPuterized Antibiotic Stewardship Study), doctors in three Swiss hospitals will     receive tips on the use of antibiotics that are integrated directly into electronic health     record and will also be given regular feedback on their use of antibiotics. Parallel to this,     data on the antimicrobial prescription practices of a control group which is not using the     system will be collected.   "
12567|NCT03120962|"     Postherpetic neuralgia (PHN) which persists more than 90 days after the resolution of the     acute shingles episode is the most common complication of herpes zoster. The continued pain     or paresthesia not only affects patient quality of life, but also causes physical disability,     emotional distress and social isolation. Conventional treatments for PHN are only partially     work in some patients or not work at all in others. Once PHN presences, it is often     refractory to the treatment, therefore, it is important to prevent the occurrence of PHN. In     the study, the investigators want to identift whether the additional use of oxycodone therapy     to current standard treatment in acute herpes zoster patients will decrease the incidence of     post-herpetic neuralgia.   "
12568|NCT03120949|"     The purpose of the study is to evaluate how safe, how effective and how well tolerated, the     study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who     have previously taken part in and completed 24 weeks of blinded treatment in one of the core     studies - CREDO 1, 2 or 3.   "
12569|NCT03120936|"     The Stay Study is a multi-site, open-label HIV pre-exposure prophylaxis (PrEP) demonstration     project for advancing PrEP delivery in the San Francisco Bay Area Transgender Community.     Approximately 188 HIV-uninfected participants will be enrolled at 4 sites in San Francisco     and Fremont and will be provided Truvada to take orally once daily as PrEP.   "
12570|NCT03120923|"     This study aims to assess and compare the effectiveness of two different volumes of local     anesthetic combined with 40mg of triamcinolone for subacromial injections in treating     patients with rotator cuff impingement syndrome   "
12571|NCT03120884|"     This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor     infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI).     Qualified 1422 patients are randomized into either of two groups: group A will undergo     conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic     sperm injection (ICSI) (711 cases). All participants will receive the same protocol for     ovarian stimulation and standardized luteal phase support.      The target population will be patients with non-male factor infertility aged ≥38years with     FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and     premature ovarian failure) are excluded.      The randomization will take place before controlled ovarian stimulation by a computer     randomization system. The accumulated live birth rate , pregnancy complications will be     followed up by checking medical records and telephone calls.   "
12572|NCT03120871|"     The Microbiome Insulin Sensitivity Study MISS is a pilot study designed to study microbiome     composition across puberty and how it relates to insulin sensitivity and secretion in obese     girls, who are at increased risk for developing type 2 diabetes in puberty. The investigators     will evaluate the gut microbiome composition in fecal samples of 57 obese girls in three     groups: prepubertal (Tanner 1), early pubertal (Tanner 2-3), and late pubertal (Tanner 4-5).     Insulin sensitivity will also be measured via an intravenous glucose tolerance test (IVGTT)     in 18 prepubertal and late pubertal participants.   "
12578|NCT03120793|"     The use of esophageal balloon catheters, which use esophageal pressure as a surrogate     measurement for transpleural pressure, shows promise in improving outcomes of patients with     severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilator. The     investigators hope to measure changes in in transpleural pressures in patients undergoing     treatment with mechanical ventilation while switching from the supine, upright (head of bed     >30 degrees), and prone positions. The goal will be to measure the changes in chest wall and     lung compliance in mechanically ventilated patients with changes in position.   "
12579|NCT03120780|"     This study is being done to investigate if there is more effective pain relief during the     latter stages of labor and delivery when epidural fentanyl 100mcg is administered compared to     epidural fentanyl 20mcg.   "
12581|NCT03120754|"     Common bile duct stones in clinical manifestations of biliary colic, obstructive jaundice,     cholangitis, pancreatitis and other symptoms. At present, thanks to the rapid development of     minimally invasive surgery and the concept of ERAS, laparoscopic common bile duct incision     and primary suture has been gradually used as a routine surgical approach in clinical     application. However, whether or not to place the abdominal drainage tube after surgery, so     far has not yet reached a consensus. Therefore, this study focuses on the clinical advantages     of LCBDE+PC placed abdominal drainage.   "
12582|NCT03120741|"     This study is an observational study that uses daily activity and environmental sensing     techniques to establish behavioral models of early dementia patients and cognitive healthy     function to assess their daily behavior and determine their activities. Specifically, the     team will collect information on a number of wireless sensors for dementia, mild cognitive     impairment and healthy elderly residents, and use special mathematical models to establish     the behavior of the two groups of subjects Model. The model will be developed a reliable     algorithm to assess health risk of the subjects.   "
12583|NCT03120728|"     This study is enrolling healthy women ages 18-39yo who are not pregnant or breastfeeding, and     are not using hormonal birth control. Initial screening visit will include a blood draw to     assess if the participant has recently ovulated. If hormone test indicates ovulation     occurred, participant will start the study 8 days after the start of their next menstrual     period. On this study visit, vaginal ultrasound will be performed to look the ovaries for     follicles. Vaginal ultrasound is then performed approximately every 2 days until the dominant     follicle has grown into the size group assigned. When this occurs the participant will place     the NuvaRing®, inside the vagina and blood will be drawn for hormone levels. Participant will     then return daily the next 5 days (total of 6 daily visits) for vaginal ultrasound and blood     draw to assess for signs of ovulation. After the 7th day the ring is in the vagina, the     participant will remove the ring from her vagina at home. After removal, there will be twice     weekly clinic visits for ultrasound and blood draw until menstrual bleeding occurs. At this     point, participation in the study is complete. Participants are compensated for their time.   "
12584|NCT03120715|"     Embryo freezing is a technique used commonly to optimize the pregnancy rate in assisted     reproduction techniques (ART). Hormone replacement therapy (HRT) regimen is applied to     prepare endometrium for frozen embryo transfer (FET) commonly.At present, It is unclear     whether preimplantation low molecular weight heparin (LMWH) improves live birth and pregnancy     rates in subfertile women undergoing FET. The study is a prospective randomized controlled     trial to compare the pregnancy outcomes of FET in hormonal replacement therapy(HRT) cycles     with or without LMWH administration before implantation.   "
12585|NCT03119662|"     This parallel-group, randomized, placebo-controlled study will examine the incidence and     severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage     III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol     (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and     underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled     post-EVAR surveillance imaging.   "
12586|NCT03119649|"     This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled,     parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to     adult subjects with a confirmed diagnosis of CF and homozygous for the F508del CFTR mutation.   "
12587|NCT03119636|"     This study will evaluate the safety and efficacy of intracerebral transplantation of human     embryonic stem cells-derived neural precursor cells in patients with Parkinson's Disease.   "
12588|NCT03119623|"     PARADOR is multisite, randomized, double-blind, phase IV clinical trial to compare the effect     of sacubitril/valsartan (Entresto™) to enalapril (Vasotec®) on blood vessel function in     subjects with heart failure with reduced ejection fraction (HFREF).   "
12589|NCT03120689|"     This is research in which students are queried by questionnaires on their satisfaction with     and experience with certain educational practices (use of a camera image projecting during a     live surgery) or with pre-recorded video. As data collection only involves survey data     collection and satisfaction with an educational experience, and randomization/intervention is     only involving use of one type of educational method versus another .   "
12590|NCT03120676|"     This is a study with the purpose of studying the safety and efficacy of the study drug     Atezolizumab in patients with relapsed or refractory Hodgkin lymphoma (HL). Atezolizumab     could shrink cancer but it could also cause side effects. This study will also test any good     and bad effects the study drug. Other aims include studying biomarkers that will help     researchers understand how the drug works.   "
12591|NCT03120663|"     In this prospective observational study, the investigators want to document     pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used antimicrobials     in an adult non critically ill surgery population (abdominal surgery, traumatology and septic     orthopedic surgery). Furthermore, the investigators want to identify risk factors for not     attaining predefined PK/PD targets.      The antibiotics of interest are amoxicillin(-clavulanic acid), flucloxacillin,     piperacillin-tazobactam, meropenem and clindamycin.   "
12592|NCT03120650|"     Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern     theories in medical anatomy has been widely used to treat ischemic stroke in China, but     effective clinical trials that verify its efficacy are lacking. This study proposes to verify     the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential     improvement of motor function between conventional rehabilitation alone and conventional     rehabilitation with Lu's scalp acupuncture.   "
12609|NCT03120429|"     the aim of present study is to compare the specific effects moderate consumption of lean fish     on weight loss of healthy obese and overweight female adults, while participants follow     energy-restricted diets also to investigate the effects of this intervention on carbohydrate     and lipid profiles, as cardiometabolic risk factors.   "
12593|NCT03120637|"     Mortality rates associated septic shock remains unacceptably high, around 20-50%, with     refractory hypotension in half of these patients. Widespread vasodilatation involves the     activation of the soluble intracellular enzyme guanylate cyclase (GC) by nitric oxide (NO),     resulting in the production of cyclic guanosine monophosphate (cGMP). Initially discovered as     an endothelium-derived relaxing factor in blood vessels, NO is made by the enzyme nitric     oxide synthase (NOS). It has been suggested that the inhibition of NO generation might be a     treatment option for sepsis and septic shock. Methylene blue (MB) is a dye that easily     crosses cell membranes, inhibits iNOS, and is capable of inhibiting the GC enzyme in vascular     smooth muscle cells.Early use of MB can block the progressive decrease in systemic vascular     resistance of patients unresponsive to noradrenaline and mitigate the need for prolonged     vasoconstrictor use. The investigators propose to study the effect of methylene blue on     cirrhotic adults with sepsis, with refractory vasoplegia unresponsive to maximum doses of     noradrenaline and vasopressin.   "
12594|NCT03120624|"     This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human     interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) in treating patients with stage IV     endometrial cancer or endometrial cancer that has come back. The study virus,     VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells     and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body     concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be     able to kill tumor cells without damaging normal cells.   "
12595|NCT03120611|"     All participants exercised during 16 weeks following a conventional intradialysis exercise     program. The last 4 weeks of the study participants were randomized into two different     exercise programs intradialysis. One group exercised through a virtual reality exercise     adapted specially for patients while receiving hemodialysis treatment. The other group     exercised with a conventional exercise program, combining aerobic cycling and strengthening     exercises.   "
12596|NCT03120598|"     A cluster randomized experiment focused on testing the extent to which the     organization-focused Implementation & Sustainment Facilitation (ISF) strategy is an effective     adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.   "
12597|NCT03120585|"     The object of this study is to determine the best way to care for infants with respiratory     distress. The investigators are testing a method of feeding fluids to infants with     respiratory distress in amounts similar to what healthy breastfed babies eat when they are     feeding on demand, and comparing this method to the current standard of care for feeding     fluids to infants with respiratory distress. These methods of feeding fluids to the study     infants will continue until the infants are able to feed normally by mouth. The study will     include about 400 infants across five sites in the United States, Chile and Argentina.   "
12598|NCT03120572|"     The purpose of this study is to investigate the effect of concurrent chemoradiation therapy     on respiratory muscle performance, lung function and functional capacity in patients with     local esophagus cancer.   "
12599|NCT03120559|"     This study proposes to evaluate the effects of using a new floss holder (GumChuck) and the     use of text messages during supportive periodontal therapy, on the psychological, behavioral     and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based     framework.   "
12600|NCT03120546|"     In this study, investigators are going to compare cervical spine motion during tracheal     intubation using video laryngoscope or rigid video stylet in patients with simulated cervical     immobilization.   "
12601|NCT03120533|"     The study is conducted to confirm the good tolerance of a continuous cathodal iontophoresis     of the treprostinil hydrogel administered during 10 days on the pulp of the finger of healthy     volunteer and on the ischemic digital ulcerations of Systemic Sclerosis patients,     particularly to estimate the cutaneous tolerance of the procedure and the effect on the blood     pressure.   "
12602|NCT03120520|"     This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18     years diagnosed with Chronic Idiopathic Constipation.   "
12603|NCT03120507|"     The Resuscitation Outcomes in the Netherlands - study assesses one-year survival and quality     of life after In-Hospital Cardiac Arrest(IHCA). It's design is a multicenter prospective     observational cohort study which will include all patients undergoing cardiopulmonary     resuscitation (CPR) for IHCA in 2017. Current literature describes poor survival after IHCA     and no risk stratification tool for long-term outcome is available. Furthermore no such study     has ever been performed in the Netherlands. The investigators aim to gain further insight in     this major adverse event.   "
12604|NCT03120494|"     75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will     be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well     as routine medical evaluations during one year. Subjects will be managed according to CDC's     guidelines on the management of PrEP as a tool for HIV prevention.   "
12605|NCT03120481|"     This is the registry of control participants for patients with various respiratory diseases.     We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam     Center for routine health check-up, and enrolled patients who agree to participate in the     study. The participants undergo baseline questionnaires, provide blood specimen and     information of the results of health check-up. We will include participants as controls if     they have no significant respiratory symptom and no significant radiographic abnormality. The     data from this registry will be compared with those from other registry of various     respiratory diseases   "
12606|NCT03120468|"     This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) +     N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo for the treatment of     alcohol use disorder (AUD).   "
12607|NCT03120455|"     The purpose of the current study is comparing the effect of almond and pistachio, as the two     common types of nuts, consumption on healthy obese and overweight female who following a     hypocaloric diet for 12 weeks. The secondary aim of the current study is to evaluate of these     two type of nuts on other cardiometabolic risk factors.   "
12611|NCT03120403|"     Postoperative pain in pediatrics can usually be well controlled with a combination of     analgesics including acetaminophen ( paracetamol) ,NSIADS, opioids , and local/regional     anesthesia.The use of epidural and subarachnoid morphine for analgesia in adults has grown     almost as quickly as Morton`s discovery of anesthesia in 1846. The application of these     techniques to the pediatric patients has evolved much more slowly,although significant     progress is being made by many investigators.   "
12612|NCT03120390|"     This randomized phase II trial studies how well physical activity works in reducing metabolic     dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness     and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes)     risk factors in patients who have breast cancer.   "
12613|NCT03120377|"     Evaluate the effectiveness of a Whole body vibration training program on quadriceps muscle     strength, functional capacity and respiratory muscle strength in adult renal transplant     recipients   "
12614|NCT03120364|"     This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to     Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay).     Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled,     and each subject is administered with single dose of vaccine which is randomly assigned.   "
12615|NCT03120351|"     The post-thoracotomy pain (PTP) has been defined as persistent or recurrent pain that lasts     for at least 2 month after thoracotomy and is associated with surgical incision or its     intercostal nerve cutaneous distribution. The latter has a prevalence of about 15% to 20%. In     about 80% of the patients such pain is moderate to severe in intensity and is associated with     depression and insomnia. According to its characteristics and possible etiology, PTP is part     of the neuropathic pain syndromes. Patients describe their chest wall pain as shooting,     burning and numbness which are descriptors often seen in other neuropathic pain syndromes.     PTP occurs most likely after partial or complete intercostal nerve damage secondary     mechanical trauma (nerve traction or compression) during surgery. The concern is that when     robotic surgery for minimally invasive approach to the heart valves or vessels such     compression and consequent damage may happen to intercostal nerves.      Therapeutic use for a lidocaine patch include post-herpetic neuralgia postthoracotomy pain,     stump neuroma pain, intercostal neuralgia, diabetic polyneuropathy, meralgia paresthetica,     complex regional pain syndrome, radiculopathy, postmastectomy pain and some other focal     peripheral neuropathic pain syndromes. It is an effective and safe topical treatment. Its     efficacy demonstrated previously in treatment of intercostal neuralgia and some patients with     post-thoracotomy syndrome can be used in treatment of perioperative chest pain related to     robotic cardiac surgery. Hypothesis is that the use of topical lidocaine will decrease pain     in acute phase after the surgery and decrease intensity of post-thoracotomy pain 6 months     after such procedure.      The effect of topical 5% lidocaine will be clinically evaluated through prospective,     randomized, placebo, double-blind study. Each patient will be assessed at admission and then,     one week after Valve Replacement (Recommended surgical procedures do not included harvesting     of leg vessels as this could be a potential confounder). Then, one month, three and six month     follow-up for all patients by mailing questionnaires and phone calls.      Upon admission, as well as 1 week, 1month, 3months and 6 months following surgical procedure,     the following tests will be performed:        -  Pain Disability Index (PDI)        -  DASS        -  VAS Pain Score        -  Opioid use (in MSO4 mg equivalents)        -  Global Perceived Effect (GPE) or patient satisfaction   "
12616|NCT03120338|"     The European Union is funding this randomised trial in Finland and Scotland as part of the     larger eCAP project (http://www.interreg-npa.eu/projects/funded-projects/project/139/). The     need for psychiatric services for children and adolescents is usually greater than the     services available. As well as this, in many cases, there is confusion as to which service     the child or young person should be referred to. The way children and young people arrive at     Child and Adolescent Mental Health Services (CAMHS) may therefore be relatively inefficient     and families could suffer as a result of this inefficiency.      The use of a computerised structured questionnaire such as the Development and Well-being     Assessment (DAWBA) offers the opportunity for these difficulties to be addressed, for the     avoidance of 'inappropriate referrals' and for more rational use of resources. It is usually     administered online through a secure internet portal. At the end of the data collection, a     computerised summary is generated from the data given by all the informants and a     child/adolescent psychiatrist lists the likely diagnosis or diagnoses in a summary of the     case and gives his view about the next steps. This is then made available to the referrer.     This community-based study aims to establish whether using the DAWBA in this way helps     children and young people with mental health problems. The main objectives are to improve     their mental health, reduce waiting times, change referral practice, increase satisfaction in     services and improve cost effectiveness. The principal outcome measure will be parent-rated     Strengths and Difficulties Questionnaire (SDQ) score 6 months after randomisation. Secondary     outcome measures will include teacher and child-rated SDQ at 6 months and waiting times to     services. The investigators will also record service use data and family out -of -pocket     costs. A random sample of young people, family and referrers will be interviewed to explore     satisfaction with service.   "
12617|NCT03120325|"     This study is investigating a new form of treatment for a digestive disorder called     gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural     dysfunction. The vagal nerve is a large nerve originating from the brain that regulates     digestive function. Patients with gastroparesis have what is a called a low vagal tone which     results in gastrointestinal motility problems and inflammation; therefore, investigators     hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce     inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators     will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and     blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of     vagal nerve stimulation (VNS) treatment.      There are 6 research visits      Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take     4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout)      Consequently, it is possible that if a patient were to be at the farthest ends of visit     windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be     less than 8 weeks which would shorten the patient's overall involvement in the study.      The treatment phase of the study will always be 4 weeks with an additional 4 week washout     phase.      Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the     treatment period.   "
12618|NCT03120312|"     The is a retrospective analysis to study the characteristics of elderly patients treated with     total hip replacements during past 5 years．   "
12619|NCT03120299|"     The purpose of this study is to conduct a multicenter randomized, double-blind,     placebo-controlled clinical trial, evaluating the effects and change of lipid metabolism,     especially of triglyceride after omega-3 administration in type 2 diabetes patients with     hypertriglyceride.   "
12620|NCT03120286|"     The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of     this study was to determine if overweight/obesity in women with PCOS were associated with an     adverse IVF outcome compared to those with normal weight.      Design: Retrospective cohort study.   "
12621|NCT03120273|"     This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will     determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of     an investigational dexlansoprazole injection after multiple intravenous administration in     healthy Chinese adults.   "
12625|NCT03120221|"     Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women.     Thus, screening first trimester healthy pregnant women for iodine status is of clinical value     for mother and child as iodine deficiency might have implications on thyroid function as well     as pregnancy outcomes   "
12626|NCT03120208|"     The objective of this cross-sectional study is to assess the prevalence of depression at 2     months, 6 months, and 1 year postpartum in women who had an immediate postpartum hemorrhage     (immediate PPH defined as blood loss ≥ 500 mL within 24 hours of delivery). The potential     serious consequences of PPH may lead to a greater number of psychological disorders in these     women than in women without PPH.   "
12627|NCT03120195|"     The aim of this study is to assess the safety and feasibility of the EndoRotor® for the     ablation of Barrett's esophagus.   "
12628|NCT03120182|"     The aim of this randomized, blinded, placebo controlled clinical study is to compare the     peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing     burr-hole trepanation for chronic subdural hematoma with and without discontinuation of     low-dose aspirin   "
12629|NCT03120169|"     Aim of this study is to investigate the effects of treadmill versus cycling endurance     training on Balance, gait performance and exercise capacity in patients with severe chronic     obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary     rehabilitation program and will be randomized into one of two intervention groups. Walking     intensity in the treadmill group will be set at 80 percent of the average speed of the     6-minute walking test. The cycling group will exercise at an intensity of 60 percent     according to an Initial incremental cycling test.      Patients will perform 5 to 6 training sessions per week. The total exercise duration will be     progressively increased from 10 to 30 minutes. Walking or cycling intensity will also be     progressively increased if perceived exertion during exercise is rated below 3 on the     modified 10-point Borg scale.   "
12630|NCT03120156|"     People with weak balance ability or subjective feeling of dizziness and unsure gait are     separated into 3 training-groups. One Group is getting no insoles, the second group is     getting modern sensomotoric insoles, and the third group is getting normal standard insoles.     All are passing a 6 week proprioceptive training.      Main outcome measurements are posturography at baseline, 3 weeks and 6 weeks. Secondary     measurements are ABC-Scale, Tinetti Gait and balance test and functional reach test at     baseline and after 6 weeks.   "
12631|NCT03120143|"     The effect of small-sided team sport training and protein intake on muscle mass, physical     function, and adaptations important for health in untrained older adults was examined.     Forty-eight untrained older (72±6 years) men and women were divided into either a team sport     group ingesting a drink high in protein (18 g) immediately and 3 h after each training     session (TS-HP, n=13), a team sport group ingesting an isocaloric drink with low protein     content (3 g; TS-LP, n=18), and a control group continuing their normal activities (CON,     n=17).   "
12632|NCT03120130|"     Amblyomin-X is an inhibitor of Factor Xa that also acts as an apoptotic agent for tumor     cells. In the case of in vitro assays, Amblyomin-X induces tumor cells to death and does not     affect the viability of normal cells. When in vivo assays were performed on mice bearing     tumors, treatment with Amblyomin-X caused a significant reduction in tumor mass and number of     metastases.   "
12633|NCT03120117|"     This is a prospective study to assess the feasibility and success of performing an     intra-operative standing cough test and the correlation with the long term success of the     sling surgery.   "
12634|NCT03120104|"     Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies     showed that pelvic floor muscle and external sphincter muscle training after stoma closure     could improve the severity of incontinence and other fecal symptoms, but there is no study     about the effects of pelvic floor muscle exercise intervention before stoma closure. We are     wondering would the symptom of fecal incontinence recover sooner and better if we give the     pelvic floor muscle exercise intervention before the stoma closure. This article aims at     comparing the effects of pelvic floor muscle training before stoma closure on fecal     incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure     (post-intervention group), and we hypothesise that the severity of fecal incontinence will     improve sooner and better in pre-intervention group.   "
12635|NCT03120091|"     Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU,     but its feasibility, accuracy and confounding factors are controversial.   "
12636|NCT03120078|"     Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or     pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound     clinic. An ultrasound will be obtained as part of the required clinical assessment before the     patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint     reporting system-various sonographic features of adenomyosis will be reported detailed,     including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination     will be done by assigned pathologist for accurate mapping/localizing the adenomyosis     (appropriate section of uterus to defining localized versus generalized adenomyosis) on all     patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with     histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for     adenomyosis based on various sonographic features/clinical symptoms and their confirmation     with histopathology will be developed.   "
12637|NCT03120065|"     The primary objective of this study is to use a well-characterized pediatric AMPATH cohort,     with detailed medication-taking, drug level, and clinical data, to longitudinally evaluate     treatment failure and drug resistance to improve long-term care for HIV-infected children in     Kenya and other RLS. Examining treatment failure and drug resistance emergence in children on     ART and what factors impact these negative outcomes, will provide needed data to critically     evaluate the efficacy of current ART, weight-based pediatric drug dosing guidelines, and     recommendations for subsequent therapies. The objective is to specifically characterize how     non-adherence leads to a lack of viral suppression and to drug resistance evolution, and how     this characterization can inform interventions to improve adherence and increase treatment     success.   "
12638|NCT03120052|"     The overall goal of this study is to identify what Physical Therapy care components are     associated with the best patient-reported functional outcome after Total Knee Replacement     (TKR) surgery. The investigators are specifically looking at outcomes at 6 and 12 months     after surgery.   "
12640|NCT03120026|"     This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis     that nutritional supplementation with whey protein, essential amino acids - mainly leucine -     vitamin D and calcium concurrent with regular, controlled physical activity would increase     the efficacy of physical rehabilitation in old adults suffering from sarcopenia   "
12641|NCT03120013|"     Neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we     currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS)     is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability     and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind,     sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with     cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with     neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short     and long term.   "
12642|NCT03120000|"     An open-label, non-randomized, two-stage, multicenter study evaluating clinical efficacy,     safety and pharmacokinetics of PQR309 in patients with relapsed or refractory Primary Central     Nervous System Lymphoma (PCNSL).   "
12643|NCT03119987|"     Acute upper-gastrointestinal bleeding (UGIB) is a commonly encountered cause of admission in     emergency department (ED). Early risk stratification allows appropriate therapy that may be     helpful to advance the patient's morbidity and mortality. We hypothesized that early RDW     levels may have an independent, linear relationship with recurrent or massive bleeding in     UGIB patients.   "
12644|NCT03119974|"     Thrombopoietin-receptor agonists (Tpo-RAs) have profoundly changed the management of ITP.     However, today, there are no international recommendations concerning the long-term use of     these costly, potentially pro-thrombotic agents, and that could induce bone marrow fibrosis     in case of prolonged treatment. Tpo-RAs have been thought to play only a supporting role in     ITP management. But our center along with many other research centers, have reported     unexpected cases of durable remission after Tpo-RAs discontinuation in adult chronic ITP. In     these retrospective studies, more than 20 % of patients were able to achieve prolonged     remission.      The purpose of this study is to demonstrate that a substantial proportion of ITP patients may     achieve a prolonged response after Tpo-RA discontinuation.      The investigators developed, in this study, a standardized procedure to discontinue     Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of     bleeding. In case of relapse after Tpo-RA discontinuation, the decision to start a new     therapy will be based on the clinician's judgment.   "
12645|NCT03119961|"     In Alzheimer's disease (AD) an imbalance between the production and clearance of the     ß-amyloid peptide is hypothesized as the driving event of the disease. The decreased     clearance of Aß could be partly linked to a progressive dysfunction of the brain vasculature     and of the blood brain barrier (BBB). Among many possible explanations for these failures of     the multiple clinical trials evaluating innovative drugs in AD, one is the lack of target     engagement, as none of these drugs is able to readily cross BBB. This barrier acts as a wall     that actively and passively prevents the crossing of molecules between the blood and the     brain parenchyma compartments. Only 0.3% of intravenously injected anti-Aß immunoglobulins     reach the brain despite a half-life of 15-20 days. Low intensity Focal ultrasound associated     to microbubble injection can open the BBB in a non invasive way. These openings are     reversible in 2 hours to 2 days depending on the intensity of the ultrasound. Ultrasound     opening of the BBB was initially used in a transgenic mouse model of AD to increase the brain     delivery of an anti-Aß antibody. In this article, the Aß load was reduced in ultrasound     treated brain region. Surprisingly it was then demonstrated that the simple opening of the     BBB without any adjunct anti-Aß treatment was able to drive the same Aß clearance effects.     This is probably linked to endogenous antibodies that are able to penetrate the brain     parenchyma and target Aß plaques. Four opening sessions elicited positive promnesic effects     in these mice. Our group conceived and developed a mean to easily, reproductively and     innocuously open the BBB. A unique extra-dural ultrasound emitter (sonoCloud®) is surgically     implanted in the skull under local anesthesia. It emits low intensity contact ultrasound     (LICU) that are not deterred by bone and thus are able to open the BBB.Preclinical studies     show the SonoCloud® device is safe and efficient as it allowed reproducible and repeatable     opening of the BBB in rabbits, dogs and non human primates. Drugs up to 2000 Kilo Daltons     (kDa) are able to cross the BBB to reach the brain parenchyma in which the concentration of     Carboplatin was increased by 700% in the BBB opened region. No adverse event was evidenced     both clinically, by EEG, Evoked potential, MRI, 18 Fluorodeoxyglucose (FDG) PET and histology     in the primates after 7 bi-monthly sessions of LICU BBB opening. SonoCloud® and its external     generator have been certified by the academic start-up CarThéra (APHP, UPMC). Our     multidisciplinary skills (neurology, neurosurgery, neuroimaging, basic science departments in     the same University hospital setting) and our previous experience of BBB opening in Man give     us the unique opportunity to translate this procedure from neuro-oncology to AD which could     1) Have a positive effect on brain lesion load and symptoms by itself and 2) allow anti-AD     (or more broadly, central nervous system) drugs to engage their targe   "
12646|NCT03119948|"     The most common motor deficiency after stroke or traumatic brain injury is hemiparesis. Most     hemiparetic patients recover walking, but rarely with a speed permitting easy ambulation     outdoors with family or friends. One of the mechanisms of gait impairment in hemiparesis is     insufficient active hip flexion during swing phase, which leads to insufficient ground     clearing at swing phase, with associated gait slowness and risks of fall.      The main hypothesis behind the present study is that insufficient hip flexion during     hemiparetic gait is partly due to overactivity of rectus femoris. Focal treatment of lower     limb muscle overactivity using botulinum toxin has not been demonstrated to increase walking     speed in hemiparesis as yet. However, most studies have focused distally, on improving foot     dorsiflexion only. The purpose of this study is to compare the effects of botulinum toxin     injection and placebo in rectus femoris (RF) + plantar flexors versus plantar flexors only.   "
12647|NCT03119935|"     This is a simulation study with a prospective randomized cross-over design. The aim of this     study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume     compare to ordinary ambu-bag   "
12648|NCT03119922|"     The main objective of this study is to evaluate at the national level (France)        -  the early healthcare practices for children with sickle cell disease screened at birth,        -  the adequacy of theses practices with the national recommendations,        -  their variability over time and according the characteristics of treatment centers.      Will be studied in particular the diffusion of the latest preventive measures (practice of     trans-cranial Doppler and pneumococcal conjugate vaccine) and their link with the residual     risks of death, stroke and invasive pneumococcal infections. The study includes all patients     born in France between 01/01/2006 and 31/12/2010. Events are recorded and analysed only     during the first 5 years of life.   "
12649|NCT03119909|"     A hallmark of our survival in the real world and of our capacity to navigate the complex     social interactions of human society is our ability to show behavioral adaptation. Adaptation     can be necessary for a number of reasons, making the study of the process challenging. Two     classes of event can signal a need for adaptation: 1) Events caused by one's own actions and     specifically FeedBack -FB- from those actions (e.g. the investigators adapt their strategy     after an erroneous choice), and 2) Events not linked to our actions, specifically     Action-InDependent Events -AiDE- (e.g. the investigators adapt their strategy after a change     of rule). These two types of information - FB and AiDE - will frequently occur concurrently.     A critical and difficult part of adapting appropriately involves resolving the difference     between the two. So for example an incorrect FB can occur because the investigators made an     error, or because something unexpected in the environment has changed -the rule switched,     someone cheated, etc. The Investigators must work out which it is, as they will frequently     require different behavioral adaptations. Their task is made even more complex by the fact     that the dynamics of evidence accumulation after FB vs AiDE are very different. FB has a     direct temporal and causal link to an executed action, which means that the investigators are     certain to derive information about a given action from a given FB. In contrast, AiDE have no     such contiguity and no initial relation to actions, which means that the investigators must     accumulate evidence to identify the appropriate adaptation to an AiDE. So the crucial dilemma     is this: after an unwanted outcome, should the investigators adapt as if they made an error     and received a negative FB, or should they continue to accumulate evidence as if there has     been an AiDE to which they need to know how to adapt. Animals are able to resolve this credit     assignment problem, as evidenced by their ability to appropriately adapt their behavior. A     breakdown of this ability to link unexpected events to their correct cause would seem to be     at the source of impairments in a wide range of psychological and neurological disorders,     from addiction and OCD to psychological symptoms in Parkinson's disease. Yet the neural basis     of this process is currently unknown, and FB and AiDE processing have been assessed     separately so far. ADAPCO will provide unprecedented characterization of brain systems     critically involved in learning from and adapting to FB, AiDE, and their interactions, thanks     to fMRI studies.   "
12670|NCT03119584|"     Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side     effects are going to be assessed at each appointment.      Patients are going to be assigned by the computer, to receive an active or non-active drug     for 14 days in a first phase. The order will be change during the second phase. The 2 weeks     break without our medication will separate these phases. A very close observation regarding     safety of our subjects will be implemented by study personnel and clinical investigators.   "
24005|NCT02971449|"     This study compares the traditional, didactic method of training Ugandan community health     workers with training using tablets in pneumonia management, a common, life-threatening     illness in children in rural areas.   "
12650|NCT03119896|"     Does the Navigator Tool Intervention improve communication regarding self-management during     consultations between healthcare professionals and people with chronic pain?      As there is usually no cure for chronic pain, healthcare professionals are increasingly     turning to methods of treatment that emphasise management of symptoms rather than elimination     of pain. However, as Pain Concern's previous research has shown, there are several barriers     to self-management that both healthcare professionals and people with pain face in their     consultations in primary care. The Navigator Tool Intervention has been designed to overcome     the majority of these barriers through improving the quality of communication regarding     self-management during consultations.      In line with the House of Care Model, where care relies on engaged and informed patients,     healthcare professionals committed to partnership working, and organisational processes that     support this, our intervention prepares both the healthcare professionals and patients for     their consultation. By providing a training session for the healthcare professionals in how     supported self-management can be brought into the consultation room, and by providing the     patients with a paper-based tool that allows them to organise their concerns and questions     prior to the consultation, the intervention aims to steer the conversation toward the aspects     that the patient needs to discuss in order to better manage their pain.      This study will launch the intervention and evaluate its effectiveness in improving     self-management support through conversation. It will be launched over a 3 month period in 4     sites across Scotland; 24 patients will be using the tool with a trained healthcare     professional and 24 will act as a control group, receiving standard care without the tool.      Questionnaires assessing the satisfaction with the consultation(s) and communication, as well     as confidence in managing one's pain, will be analysed and compared between the two groups.     Interviews will be carried out with healthcare professionals and a sample of patients having     used the tool to gain a deeper understanding of the usefulness of the intervention and how it     may be improved in the future.   "
12651|NCT03119883|"     The utilization of glutamine by the bone marrow plasma cells in MGUS and MM will be compared     between each other after infusion of 13-carbon labelled glutamine.   "
12652|NCT03119870|"     Efficient evaluation and monitoring of actions and outcomes are a key feature of primates'     efficient adaptive cognition. Deficits in evaluating one's own actions and their consequences     is a key feature of prominent disorders such as obsessive compulsive disorders (OCD),     schizophrenia, and anxiety. The Investigators know that these evaluative processes implicate     medial structures of the brain that are related both to old limbic functions and to more     recently evolved higher executive functions. Brain potentials related to performance     monitoring have attracted a lot of interest in cognitive neuroscience but also in the     clinical domain because they appear to be altered in different neurological or psychiatric     disorders, such as schizophrenia, OCD, or anxiety, and could become biomarkers of     pathologies. But the neural sources of these markers are not fully determined and are     currently highly debated. In addition, our work suggests that non pathological factors, such     as normal morphological cortical variations, could affect those markers. Understanding     performance monitoring, acting directly on medial cortex, or using electrophysiological     markers in clinic are thus currently problematic and challenging. This is mostly because     structure-function relationships in the medial wall are ill defined for historical,     conceptual, and methodological reasons. Importantly, although individual variability of brain     morphology impedes precise assessment of structure function relationships, this variability     is almost never taken into account. EEG-Feedback aims to resolve these issues by evaluating     the consequences of individual variability in cingulate cortex morphology on 1) surface EEG     markers of feedback monitoring and 2) functional connectivity patterns thanks to     resting-state fMRI.   "
12653|NCT03119857|"     Summary      In patients with prostate cancer (PC) who have only biochemically relapsed disease after     curative treatment (or some locally advanced PC patients), hormonal therapy remains a de     facto standard of care treatment. Adding docetaxel-based chemotherapy to a standard-of-care     hormonal therapy has an increased potential to treat prostate cancer cell clones resistant to     androgen withdrawal and to possibly shorten the duration of therapy needed to control the     disease.      This clinical trial is designed on the basis of an unmet clinical need, as well as other     factors including: 1) a consensus among investigators on endpoints for studies of patients     with a rising PSA, 2) the ability to identify subjects at high risk for developing     radiographic metastases, 3) the fact that hormonal therapy has already been shown to improve     survival when applied early in the natural history, and 4) the availability of chemotherapy     such as docetaxel that can improve survival in subjects with advanced disease.      It is our hypothesis that a more appropriate group of patients who may benefit from the     curative potential of systemic chemo-hormonal modality is that with minimal, but detectable     disease who have a high probability of developing metastatic disease, clinical symptoms and     eventually death from prostate cancer in a defined time frame. The investigators hypothesize     further that the approach is likely to be more effective at a time of minimal tumour burden,     resulting in minimization of the overall burden of therapy and better quality of life while     on treatment.      This trial will determine whether any benefit is gained by adding chemotherapy to hormonal     therapy alone in the population of subjects with a rising PSA. Two therapeutic approaches     will be compared in this two-arm randomized clinical trial. The control Arm A provides     antiandrogen (bicalutamide 150 mg x 1) alone. The experimental Arm B involves treatment with     docetaxel for 8-10 cycles and antiandrogen (bicalutamide 150 mg x 1) treatment. For the     schematic representation of study design please see Section 7.3.1.      Subjects with a rising PSA following definitive local curative therapy will be eligible, if     their PSA doubling time is < 12 months. Also PC patients planned for anti-.androgen therapy     are eligible, with the same criteria. Subjects with radiographic metastases will be excluded.     The primary endpoint of the trial is progression-free survival of subjects that do not     experience biochemical failure at 60 months from the start of therapy.      Based on the yearly number of prostate cancer patients who undergo definitive local therapies     and the estimated probabilities of relapse, upwards of 400 men (if +15% improvement) in the     Scandinavian countries are potential candidates for this approach.   "
12654|NCT03119844|"     Heart failure affects not only the cardiovascular system with structural abnormalities of the     heart, but also the musculoskeletal system, leading to exercise intolerance. Objective: To     evaluate the effects of a short-term exercise protocol and phototherapy, on the functional     capacity and inflammatory markers in patients with heart failure. In addition, the     investigators will investigate pulmonary function, peripheral and respiratory muscle strength     and quality of life. Methods: Heart failure patients (left ventricular ejection fraction <     40%) will be selected from the outpatient clinic of the myocardium of the Department of     Cardiology of Unifesp and randomized among two groups: patients who will be submitted to     placebo phototherapy and cycle ergometer exercise; and patients who will be submitted to     active phototherapy and cycle ergometer exercise. All groups will receive treatment twice a     week for four weeks. Patients will be instructed to conduct home-based walking program at     least twice a week. Patients will be evaluated before and after protocols regarding the     pulmonary function, peripheral and respiratory muscle strength, functionality, quality of     life and evaluation of systemic inflammatory mediators.   "
12655|NCT03119831|"     Aim: This study compared the effectiveness of three different mouthrinses (alcohol and     non-alcohol chlorhexidine, alkyl dimethyl glycine / alkyl dimethyl amine oxide - C31G) in     plaque control and early wound healing, postoperatively.      Materials and Methods: In this, randomized, double-blind, controlled clinical trial 42     patients were allocated to three groups assigned to two weeks rinsing after periodontal     surgery with C31G (group A), alcohol-free chlorhexidine 0.12% (group B) or alcohol-based     chlorhexidine 0.12% (group C). At weeks 1 and 2, plaque and early wound healing indices were     recorded. At day 14, total bacterial counts were estimated utilizing real - time qPCR.     Statistics included linear and generalized linear mixed models.   "
12710|NCT03119051|"     This study evaluates the effects of computerized cognitive training on different cognitive     domains in mild cognitive impairment (MCI) patients. Patients will be randomized into the     computerized training group and the control group in 1:1 ratio.   "
12656|NCT03119818|"     End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal     phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular     risk and mortality. Thus, three therapeutic options have been developed: dietary restriction,     administration of phosphate binders and phosphorus clearance by hemodialysis (HD).      During a standard HD session, around 600 to 700mg phosphate is removed from the plasma,     whereas it contains only 90 mg inorganic phosphate (Pi); 85% of phosphate is stored in bones     and teeth in hydroxyapatite form, 14% is stored in the intracellular space (90% organic     phosphate and 10% Pi), and 1% remains in the extracellular space.      Currently, the source of Pi cleared during HD remains to be determined. Phosphorus (31P)     magnetic resonance spectroscopy allows reliable, dynamic and non-invasive measurements of     phosphate intracellular concentration. The investigator's team recently published data     obtained in anephric pigs, suggesting that phosphate intracellular concentration increases     during a HD session. In parallel, we showed that ATP intracellular concentration decreased.     These results suggest that the source of Pi cleared during HD could be located inside the     cell.      In this study, investigators will measure intracellular phosphate and ATP concentrations and     intracellular potential of hydrogen (pH) evolution during hemodialysis in 12 patients     suffering from end-stage renal disease by MR spectroscopy.      If these results were confirmed in humans, it could explain, at least in part, HD intolerance     in some patients and would lead to modify therapeutic approaches of hyperphosphatemia, for     example, by modifying HD sessions time.   "
12657|NCT03119805|"     The purpose of this study is to define cut-off values of the most widely used composite     scores and patient-reported outcomes, for levels corresponding to remission/low disease     activity and for changes in levels corresponding to flares, in PsA, when remission/low     disease activity and flare are defined from the patient and physician perspective. The ReFlaP     (Remission/Flare in PsA) study is a prospective, multicentric international, longitudinal,     observational study.   "
12658|NCT03119792|"     In May 2009 in Bogota, Colombia, the Si! program conducted a cluster randomized trial in 1216     children between the ages of 3 and 6 years old, and 928 parents with the aim of evaluating a     five month education intervention to change knowledge, attitudes and habits related to a     healthy diet and active lifestyle in preschoolers. The results showed that the program was     feasible and effective. The Si! Program will perform a new follow up of its original children     cohort, now between the ages of 9 and 13 years. The original cohort will be compared to a new     comparable cohort to assess baseline knowledge, attitudes and habits of healthy lifestyles in     knowledge, attitudes, habits and emotions towards a healthy lifestyles . A community     pedagogical intervention in healthy lifestyles on cardiovascular health will be implemented     in the intervention group.   "
12659|NCT03119779|"     Objective:      To assess which is the most efficient pulpotomy medicament on tooth survival in patients with     a cariously-exposed vital young permanent molar regarding: absence of postoperative pain,     sinus or swelling, internal/ external root resorption, periapical radiolucency), root     maturation and decrease chair side time of treated patient.      Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and     allocation ratio (1:1), equivalence framework.   "
12660|NCT03119766|"     Purpose of the study:      To obtain additional data on efficacy and safety of Kolofort in functional dyspepsia patients   "
12661|NCT03119753|"     In this study we are going to compare dimensional accuracy of maxillary complete denture base     fabricated by using rapid prototyping method and conventional method.      We hypothesize that both techniques do not significantly differ from each other   "
12662|NCT03119740|"     The frequency of complications after appendectomy is about 9% . The predictive value of CRP     as an indicator of postoperative complications has been addressed in a small number of     studies. The aim of the present retrospective analysis was to determine whether postoperative     CRP levels are a reliable predictor of postoperative complications.   "
12663|NCT03119727|"     Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)   "
12664|NCT03119714|"     The purpose of this study is to establish the influence of the non-steroidal candidate-drug     pemirolast on allergen-induced airway obstruction and inflammation in allergic subjects with     asthma. Pemirolast is an orally available inhibitor of the release of mast cell mediators.     The study will therefore test the hypothesis that global inhibition of the mast cell,     resulting in decreased production of most of its mediator molecules, will provide a highly     significant anti-asthmatic effect.   "
12665|NCT03119701|"     A study to assess effectiveness and safety of a drug FP-1201-lyo (Recombinant Human     Interferon Beta-1a) in the Prevention of Multi-Organ Failure on patients after Open Surgery     for a Ruptured Abdominal Aortic Aneurysm   "
12666|NCT03119688|"     The objective of this clinical study is to assess the relative mildness of a cosmetic facial     cleanser in comparison to water through repeated application to the volar forearm using the     FCAT wash procedure.   "
12667|NCT03119675|"     Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a     photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)      Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™     App and patients are evaluated with cycloplegic refraction.   "
12668|NCT03119610|"     Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability     in older adults. Although exercise can counteract the effects of obesity and sarcopenia, many     have difficulty adhering to an exercise program and the benefits of exercise are variable.     Therefore, there is an urgent need to test novel pharmacologic interventions to prevent     disability and loss of independence. Oxytocin is a pituitary hormone released during     parturition and lactation that is also known to suppress appetite in rodents and humans; and,     recent small studies have found that intranasal oxytocin reduces body weight in adults. We     propose a pilot study of intranasal oxytocin as a novel approach to promote weight loss and     increase muscle mass in older subjects with sarcopenic obesity.   "
12669|NCT03119597|"     The purpose of this study is to determine whether a 4-week dietary intervention with wild     blueberry powder can have an effect on cognitive performance in participants aged between     13-17.   "
15733|NCT03079544|"     The purpose of this study is to collect data from patients by social media and self-report on     the adverse events and outcomes happened with patients with extranodal natural killer/T-cell     lymphoma, nasal type, who are treated outside of clinical trials in China.   "
12671|NCT03119571|"     To determine if survival to hospital discharge with good neurological outcome for adults ages     18-75 who are resuscitated from out-of-hospital VT/VF cardiac arrest without clinical signs     of a heart attack do better by going straight to the cardiac catheterization laboratory or     admitted to the intensive care unit for evaluation. The investigators think a large portion     of resuscitated patients presenting with VT/VF have ischemic heart disease which is the cause     for the arrest. And prompt access to the cardiac catheterization laboratory to reverse the     blocked artery will improve survival with good neurological outcomes.   "
12672|NCT03119558|"     Cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called     amyloid in the heart tissue. This makes it difficult for the heart to function properly. The     investigators wish to evaluate if the radiopharmaceutical 18F‑Florbetaben (Neuraceq®) that     targets beta amyloid can also identify cardiac amyloid deposition.   "
12673|NCT03119545|"     The overall purpose of this project is to evaluate a family-centered intervention (the Family     Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is     seriously ill and cared for in specialized homecare. The aims of the intervention are to     increase family communication, the families' awareness of the impending death and their     knowledge about the cancer illness, and thereby reduce the family members' long-term     psychological distress.   "
12674|NCT03119532|"     Over 40 million major operative procedures are performed in the US annually and comprise     about 40% of healthcare expenditures. Despite decades of research, perioperative mortality     and morbidity remain a major healthcare system cost and detriment to long-term quality of     life. More than ten percent of patients experience a significant event such as surgical site     infection, reoperation, myocardial infarction, pulmonary embolus, or death. Nearly 100,000     patients die after surgery each year. National data demonstrate a 3-fold variation in risk     adjusted surgical morbidity and mortality, suggesting many opportunities for improvement in     perioperative care.      Anesthesiology care demonstrates wide variation in practice. Sometimes, this variation is     appropriate because the anesthesiologist is responding to patient comorbidities or procedure     specific events. However, even after controlling for patient specific factors, there is a     substantial amount of unexplained variation in fundamental elements of anesthesiology care.     The same procedure and patient can be performed using completely different anesthetic     techniques, hemodynamic management strategies, and medications. This variation in care can     lead to a variation in outcome.      The use of electronic health records (EHR) with detailed preoperative and intraoperative data     allows an automated system to be developed to notify clinicians their compliance to both     process of care metrics and outcome metrics. The Multicenter Perioperative Outcomes Group     (MPOG) quality improvement arm is known as Anesthesiology Performance Improvement Reporting     Exchange (ASPIRE). Like other Collaborative Quality Initiatives, the primary goal of ASPIRE     is to provide hospitals with risk-adjusted feedback on outcome and process of care variation.     In addition, ASPIRE creates an active best-practice sharing environment to enable data to     spur action. Recent literature has demonstrated that hospital-level feedback may not be     adequate to improve performance and clinical outcomes. In addition to hospital level data and     feedback, ASPIRE can disseminate provider-specific electronic feedback that may decrease     variation in care known to impact complications and cost.      The primary aim for this research study on ASPIRE's QI program is to determine if the     investigators can change behavior as measured by a provider's compliance to specific     performance metrics. The investigators believe that the start of individual provider     performance feedback reports to ASPIRE members presents a unique opportunity to research the     efficacy of these novel tools. The investigators propose to test the hypothesis that monthly     provider specific feedback emails on ASPIRE quality metrics over a period of 9 months     improves provider compliance as measured by a either a 10% improvement in the Total     Performance Score or by moving from below to above the 90% performance threshold in the Total     Performance Score Index.      Each provider type (faculty, CRNA, resident/fellow) within a hospital participating in ASPIRE     will be individually randomized to either receiving the electronic performance improvement     email or not for a total of nine months. No individual at the participating site will see the     individualized email compliance reports except for the specific provider. Only an aggregate     of the compliance across the entire hospital will be supplied to the chairperson and the     quality assurance directors. After the completion of the nine month randomization period, all     providers will receive monthly ASPIRE performance improvement emails.      The University of Michigan is the coordinating center but also participating in this research     on QI project. De-identified patient data will be pulled in aggregate for each provider using     the MPOG database. The provider performance for each measure will then be sent from ASPIRE to     the randomized care provider via an email. The chairperson and quality assurance directors     will only see aggregate data on compliance rates and can NOT identify individual compliance     rates. Each participating site will obtain their own institutional IRB to participate in this     study.   "
12675|NCT03119519|"     Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of     this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in     this subset of patients.   "
12676|NCT03119506|"     This study aims to understand the interaction between school recess activity and duration and     lunch choices among elementary school children   "
12677|NCT03119493|"     Autonomic disfunction present in metabolic syndrome subjects is related by a greater     vulnerability of the heart and risk of cardiovascular events. In this context, aerobic     interval training has been highlighted by its easy applicability and benefits effects in     autonomic modulation in different populations. Therefore the studies that use de aerobic     interval training in this different populations didn't realize a periodization of training     with preparatory periods with progressive increase of load, specific phases with less     duration predominating the intensity and transition periods for recuperation. Additionally,     there isn't studies that investigate the effects of aerobic interval training in autonomic     modulation of individuals with metabolic syndrome. In this context, periodized aerobic     interval training can arise like a new type of treatment that offering security and efficacy     in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of     periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and     anthropometric parameters of individuals with metabolic syndrome.   "
12678|NCT03119480|"     To set up electronic early warning system of AKI patients; To develop AKI's intervention, the     follow-up process, and the renal physician is responsible for the implementation.      To Observe the method after implementing the treatment efficacy of AKI and the differences     between the traditional treatment process.   "
12679|NCT03119467|"     A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or     Refractory Non-Hodgkin Lymphoma   "
12680|NCT03119454|"     Evaluation of pharmacokinetic parameters of diprospan in long term when administered     systemically in patients in routine medical practice.      Applied research project.      Design: open-comparative prospective cohort study.      Two groups of subjects:        -  patients who are receiving diprospan in standard therapy of their existing disease, or          multiple times, but following the introduction of diprospan is planned no earlier than          28 days after the first,        -  control group of subjects for the study of pharmacokinetic parameters diprospan and its          metabolites.      Objectives of the study: to evaluate the pharmacokinetic parameters of Diprospan in the long     term when administered systemically in patients in routine practice.   "
12681|NCT03119441|"     The aim of this study is to assess the efficacy of dental water jet in plaque removal and     gingival health during orthodontic treatment with fixed appliances.   "
12682|NCT03119428|"     The purpose of this study is to evaluate the safety and efficacy of OMP-31M32. OMP-313M32 is     an experimental anti-TIGIT antibody that was developed to block TIGIT from binding PVR     allowing the body's T-cells to destroy cancer cells.   "
12683|NCT03119415|"     Students' cooperative and prosocial behavior is vital to their social and academic success     and to the quality of a school's social environment. This project will evaluate an     instructional technique that could benefit students and schools by encouraging higher levels     of prosocial behavior among students and promoting social integration and inclusion,     particularly for marginalized students. The instructional technique is called cooperative     learning which involves students working in groups toward shared academic goals. Previous     research indicates that cooperative learning promotes social acceptance and increases     academic engagement and achievement. However, it has not been evaluated as a technique to     reduce student behavioral problems and promote greater school safety. There is strong reason     to believe that it will have these benefits, since cooperative learning brings together     students from diverse social groups and provides them the opportunity to work together toward     shared goals in a positive setting.   "
12684|NCT03119402|"     The purpose of the study is to evaluate the effectiveness of the combination of Rhythmic     Reading Training (RRT), a computer-assisted intervention method that combines sublexical     reading exercises with rhythm processing, and transcranial direct current stimulation (tDCS)     on reading abilities of a group of Italian undergraduate students with dyslexia. Two     experimental conditions (active vs. sham) will be compared. Finally, the effects of the     intervention on other cognitive functions involved in the process of reading (i.e., rapid     automatized naming, verbal working memory, rhythm perception abilities) will be measured.   "
12711|NCT03119038|"     The purpose of this study is to clarify the efficacy of a multidrug versus single drug     periarticular injection when only standard operative and postoperative pain management     protocols used and the control group is exposed to what our investigators believe is the     standard of care, single medication periarticular injection   "
15734|NCT03079531|"     This is a study to determine whether secukinumab is a potential therapy for those with     papulopustular rosacea. We will observe whether this drug decreases the size and/or amount     and severity of the pustules of those who suffer from rosacea.   "
12685|NCT03119389|"     The necessity of Hand hygiene (HH) before donning non-sterile gloves is unknown. Furthermore,     because of the additional time required to cleanse hands and then don gloves, as well as the     cumbersome nature of applying gloves to recently washed hands, this practice leads to     non-compliance with both HH and glove use - placing patients at risk. In a pilot study, the     investigators performed a randomized trial of 230 healthcare workers and demonstrated no     difference in total bacterial colony counts or identification of pathogenic bacteria from the     gloves of persons who either performed HH or did not perform HH prior to putting on     non-sterile gloves. If unnecessary, HH before non-sterile glove use wastes valuable time,     which might otherwise be spent engaged in direct patient care. And removing this unnecessary     step may lead to increased compliance with infection prevention measures. In Aim A, the     investigators will perform a multi-center randomized control trial to evaluate the efficacy     of a direct gloving strategy to improve compliance with infection prevention practices. In     Aim B, the investigators will perform a nested multi-center validation study, where the     gloved hands of healthcare workers will be randomly sampled to determine bacterial     contamination of non-sterile gloves after donning.   "
12686|NCT03119376|"     The peer review process is a cornerstone of biomedical research publication. Despite being     essential, the assessment of the completeness of the reporting and the identification of     switched outcomes are not appropriately performed. Furthermore, these tasks do not suppose a     high level of expertise and could be performed by junior researchers.      To assess the completeness of reporting and identified switched outcome(s), junior peer     reviewers could use a simple online tool (COBPeer) based on the CONSORT (Consolidated     Standards of Reporting Trials) 2010 checklist and Elaboration and Explanation publication for     reporting parallel-group RCTs. The tool would feature bullet points eliciting the meaning of     each checklist item. The aim of this study that will compare the accuracy of junior peer     reviewers using the tool to that of usual peer reviewers when evaluating the completeness of     reporting and switched of primary outcome(s) in reports of RCTs   "
12687|NCT03119363|"     Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere     with activities of daily living long after completion of medical treatment. Pharmacologic     agents to treat CRF have been studied but there is insufficient evidence to recommend their     use. Non-pharmacological interventions for CRF have also been studied but are costly to     implement and involve significant patient burden. This study investigates a novel low-cost/     low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of     multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years     post-autologous stem cell transplant (ASCT) will be recruited from two medical centers. The     light will be administered by a small, personal Litebox daily for 4 weeks. Outcomes will be     assessed at five separate time points, including baseline and follow-up. The study will     specifically address recommendations made for interventions for CRF from the NCI Clinical     Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite     study with a carefully delineated comparison condition to investigate the effects of light on     CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include     only survivors who experience clinical levels of CRF; and 4) address possible psychological     and biological mechanisms. This study will have major public health relevance as it will     determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively     reduces CRF.   "
12688|NCT03119350|"     Considering that the failure of the treatment of obesity is justified by the multifactorial     pathophysiology of this morbidity, the present project has the following hypotheses:        1. The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;        2. The unbalance is therapeutically modified through physical training ;        3. Obesity courses with the break-down in energy metabolism mitochondrial disease          associated with systemic inflammatory characteristics that can be corrected through a          combined long-term physical training program.      This study have as objective : to analyse changes in mitochondrial function, inflammatory     profile, oxidative stress and energy metabolism caused by concurrent physical training in     obese women.   "
12689|NCT03119337|"     Voluntary medical male circumcision (VMMC) in sub-Saharan Africa is safe: the average rate of     moderate and severe adverse events (AEs) at the country level is 0.8%, corresponding to 99%     of men healing without incident. To reach the global target of 20 million by 2018, VMMC     productivity needs to double in countries already plagued by severe healthcare worker     shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health     and Child Care (MoHCC) and performed over 120,000 VMMCs. Current VMMC care in Zimbabwe     requires in-person, follow-up visits at post-operative days 2,7, and 42. Over 95% adhere to     multiple follow-up visits within 14 days of VMMC. ZAZIC's program has an overall AE rate of     0.4%; therefore, overstretched clinic staff conducted more than 200,000 unnecessary reviews     for VMMC clients without complications. High mobile phone ownership, severe healthcare worker     shortages, and rapid VMMC scale up make ZAZIC's VMMC program an ideal setting to test a     mobile health (mHealth) intervention to reduce provider workload while safeguarding patient     safety. Through an un-blinded, prospective, randomized, control trial (RCT) in high-volume     facilities providing VMMC, ZAZIC will implement an interactive, two-way texting (2wT)     intervention to identify men healing without complication, allowing them to decline routine     in-person follow up visits. 2wT will simultaneously identify men with any sign of an adverse     event, encouraging rapid in-person follow-up when an AE is suspected on any day, reducing     unnecessary visits while maintaining quality care. We aim to 1) determine if 2wT can safely     reduce VMMC follow-up visits; 2) estimate the cost savings associated with 2wT over routine     VMMC follow-up; and 3) assess the acceptability and feasibility of 2wT for further scale-up.     It is expected that this intervention with be as safe as routine care while providing     distinct advantages in terms of efficiency, costs, and reduced healthcare worker burden. This     approach is innovative as it focuses on using a low-cost mHealth intervention to reduce     provider workload without deterioration in quality care. The success of this intervention     could lead to adoption of this intervention at the national level, increasing efficiency of     VMMC scale up and reducing burdens on providers and patients   "
12690|NCT03119324|"     The Low Level Laser Therapy (LLLT) has been recently introduced with success in the     management of the pain associated to this condition. This double blind placebo controlled     clinical trial analyzes a new home LLLT protocol to verify whether it was possible to avoid     to the repeated presence at dental chair required by traditional LLLT protocols.   "
12691|NCT03119311|"     Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists     measured the angle of ocular deviation using alternate prism cover test (APCT). The video     files and data with the changes in ocular deviation during the alternate cover test were     obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared     the value obtained using VOG and the angle of a rotating model eye, and subsequently made a     new linear equation using these data. The calculated values obtained using VOG were compared     with those obtained using APCT to determine the diagnostic accuracy of VOG.   "
12692|NCT03119298|"     The study's aims are twofold: First, to examine physiological correlates of fear of physical     activity (PA) and second, to examine correlates between fear of PA and interoceptive     abilities in patients with chronic heart failure compared to healthy persons. Patients' fear     of PA will be assessed via the Fear of Activity in Situations - Heart Failure (FActS-HF)     questionnaire. The patient group will be split into two subgroups: One with high fear of PA     and the second with low fear of PA based on FActS-HF scores (first control group). Fear of PA     will be assessed via an adapted version of FActS-HF in a sample of healthy persons (second     control group). Each member of the high-fear-of-PA group will be individually matched with     one member of the second control group, based on sex and age. The participants of all three     groups undergo the same experimental trials.      Aim 1: The startle paradigm will be used to investigate the physiological component of fear     of PA. The startle paradigm is based on empirical observations that the startle reflex is     larger after the priming with unpleasant stimuli and inhibited after the priming with     pleasant stimuli. The participants will be primed with various words including those words     associated with physical activity that are expected to be unpleasant in patients with high     fear of PA. The startle reflex will be triggered by air puffs on the eyes (startle probes)     and measured via facial electromyography (EMG). We assume that startle responses primed with     PA related words are stronger in patients with high fear of PA compared to the control     groups.      Aim 2: Interoceptive accuracy will be assessed via the Schandry test and interoceptive     awareness will be assessed via the Multidimensional Assessment of Interoceptive Awareness     (MAIA) questionnaire. During the Schandry test the participants will be instructed to     subjectively count their heart rate without any aid or tools. The heart rate will be     objectively measured at the same time via ECG. A high congruence of the objective and     subjective results indicate a high interoception ability, and is assumed to be correlated     with high fear of physical activity. Additionally, we expect positive correlations between     the MAIA and FActS scores.   "
12693|NCT03119285|"     The investigators propose to test for non-BRCA1/2 mutations in new and existing families with     hereditary ovarian cancer in order to better define penetrance and associated malignancies of     rare ovarian cancer susceptibility genes. The hypothesis is at least one third of hereditary     ovarian carcinoma families wildtype for BRCA1/2 can be solved using an updated version of     BROCA (BROCA-HR) that targets 47 genes, including all known ovarian cancer genes and     additional candidate genes in related pathways. The objective is to identify families with     mutations in rare ovarian cancer susceptibility genes and test both affected and unaffected     family members, thereby generating a rough estimate of penetrance for each mutated gene as     well as identify new ovarian cancer susceptibility genes. The investigators also plan to     enroll self identified African America women, who have been drastically under-represented in     clinical cancer genetic testing programs and in OC susceptibility research.   "
12694|NCT03119272|"     The purpose of this research study is to analyze the microorganisms residing in the gut of     patients with anorexia nervosa. Research has begun to link changes in the intestinal     microbiota with diseases such as inflammatory bowel disease (IBS), asthma, and obesity, but     although some studies have investigated the intestinal microbiota in overweight/obese     individuals, very little is known about the intestinal microbiota in underweight individuals.     The investigators aim to identify the enteric bacterial groups associated with adiposity,     BMI, anxiety, and stress in patients with anorexia nervosa.   "
12695|NCT03119259|"     The primary purpose of this study is to test whether coupling of a mobile health technology     application (HABC 2.0) with the Aging Brain Care (ABC) Clinical Program improves (1) the     behavioral and psychological symptoms of patients suffering from Alzheimer's disease and     related dementias (ADRD) and (2) the distress of their informal caregivers.      Hypothesis #1:Patients who receive HABC 2.0 coupled with the ABC Clinical Program will have     fewer symptoms at 12 months compared to those who receive the ABC Clinical Program only; and     informal caregivers of patients who receive HABC 2.0 coupled with the ABC Clinical Program     will have lower caregiver distress at 12 months compared to caregivers of patients who     receive the ABC Clinical Program only.      The secondary purpose of this study is to test whether combining HABC 2.0 with the ABC     Clinical Program (1) reduces the number of emergency room and hospital visits for patients     and their informal caregivers; (2) reduces the depressive symptoms and caregiver burden of     informal caregivers; and (3) increases the caregiving self-efficacy of the informal     caregivers.      Hypothesis #2: Patients and caregivers who receive HABC 2.0 coupled with the ABC Clinical     Program will have fewer emergency room and hospital visits at 12 months compared to these who     receive the ABC Clinical Program only; and informal caregivers of patients who receive HABC     2.0 coupled with the ABC Clinical Program will have fewer depressive symptoms, lower     caregiver burden and higher caregiving self-efficacy at 12 months compared to caregivers of     patients who receive the ABC Clinical Program only;.   "
12696|NCT03119246|"     Huntington's disease (HD) is an inherited neurodegenerative disease for which there are no     existing disease-modifying treatments.      Repair-HD is an EU FP7 consortium that aims to establish all the preclinical requirements for     transplantation of stem cell-derived neurons in HD in order to replace those lost to the     disease process. These requirements include the generation of new clinical assessments for     detailed monitoring of patients with HD who have undergone cell replacement therapy.      This protocol describes the beta testing of a new clinical assessment battery: Core     Assessment Protocol for Intrastriatal Transplantation in HD version 2 (CAPIT-HD beta /     CAPIT-HD2). CAPIT-HD beta represents a substantial revision of a previous CAPIT-HD battery     published over 20 years ago, which is in need of updating in order to accommodate knowledge     from clinical transplant studies over this time and to take advantage of technological     advances in patient assessment.      HD is a complex disorder in which there is relentless deterioration of motor, cognitive and     behavioural functions, usually from mid-life onwards. The original CAPIT battery aimed to     capture elements of change in all three domains, but was based predominantly on subjective     semi-quantitative assessment tools that have poor inter-rater reliability. Moreover, a number     of deficits, such as impairments in social cognition, were not recognised when the original     CAPIT-HD battery was constructed, so we have developed novel assessments of these deficits,     some of which are included in CAPIT-HD beta. The beta testing will take place in established     HD clinical centres in Cardiff, Manchester, Paris, and Munster by teams of researchers who     are experienced in leading clinic research in HD. Patients with early to moderate HD will be     assessed at baseline, and at one and twelve months later, to assess the reliability and     sensitivity of the CAPIT-HD beta battery. Arrangements for data storage and analysis are in     place.   "
12697|NCT03119233|"     To assess the safety and effectiveness of the PQ Bypass System to access, deliver guidewires     and implant stent grafts for a percutaneous fem-pop bypass.   "
12698|NCT03119220|"     The current study aims to counteract perceived stress-related barriers to implementation and     maintenance of positive health behavior change (i.e., increasing physical activity), by     providing an individually tailored and comprehensive informational support program. This     translates into an intervention that, in addition to behavior monitoring (low informational     support), will provide comprehensive informational support by combining advice and     suggestions on how to achieve positive physical activity change with information on the     health effects of such a change (high informational support). The latter will be achieved by     providing information on general health benefits of increasing physical activity as well as     on how physical activity change is linked to individual changes in health-relevant outcomes     (i.e., mood and sleep quality changes). Specifically, it is hypothesized that:        -  Higher chronic stress levels in general as well as stress perceived by the anticipated          task of improving physical activity will be negatively associated with physical activity          changes.        -  Participants receiving informational support will show decreases in task-related stress.        -  Furthermore, participants who receive comprehensive informational support will show          larger physical activity improvements than participants who do not receive informational          support.        -  Initial stress will act as a moderator of the effects of informational support on          physical activity, such that higher initial stress will reduce the positive effects of          informational support.      Importantly, the proposed intervention is specifically designed to support the subsequent     development of an intervention program that is not only feasible, but easy to implement by     individuals motivated to achieve a positive health behavior change. A key factor will be the     insights gained into stress as a mechanism that counteracts implementation and maintenance of     behavior change. This is especially important given the central role of stress in negative     health outcomes associated with lack of physical activity, such as poor sleep, negative mood,     and chronic low-grade inflammation.   "
12699|NCT03119207|"     Specific Aims:        1. Quantify baseline patient room disruptions in the medical ICU during the proposed          nocturnal Naptime .             1. Obtain baseline light and noise levels in selected medical ICU study rooms.             2. Obtain baseline activity level levels in selected medical ICU study rooms.             3. Assess baseline information regarding nursing experience, prior training / beliefs               regarding sleep promotion in the medical ICU        2. Assess the feasibility of instituting a 4 hour (Midnight to 4:00 AM) nocturnal Naptime          with minimization of patient interaction via tracking of differences in patient room          activity, light and noise levels in control versus intervention patients.           Secondary Aim        3. Examine the associations between Naptime provision and patient sleep quality.   "
12700|NCT03119194|"     The purpose is to and to assess the mass balance recovery after a single oral dose of     [14C]-BIA 9-1067 and to provide plasma, urine and faecal samples for metabolite profiling and     structural identification.   "
12701|NCT03119168|"     This study is evaluating the effect of adding a high dose of simethicone to the standard     polyethylene glycol preparation for screening colonoscopy in the quality of the preparation ,     adenoma detection rate and withdrawal times.   "
12702|NCT03119155|"     The objective of this study is to improve the diagnosis level of fetal congenital heart     disease by the multi-center collaboration in China.   "
12703|NCT03119142|"     The socioeconomic gradient in health is well known and is partially explained by differences     in health-related behaviours across socioeconomic groups. There is reason to believe that the     current economic crisis has been contributing to the observed rapid decrease in the adherence     to the Mediterranean diet, thus reducing a protective factor against the development of major     chronic diseases. This project aims at investigating whether the economic crisis could     account for the shifting from the Mediterranean diet. Additionally, it will address     variations in inflammation biomarkers (possibly dietary-related) or metabolic phenotypes as     useful biological accounts for the decline in the adherence to Mediterranean diet. This     project will also test whether for economically weakest people cultural resources could     somehow attenuate the impact of material circumstances on lifestyle changes attributable to     the economic crisis.   "
12704|NCT03119129|"     The purposes of this study are to complete the development of a video-enhanced, school-based     drug prevention program for rural Hawaiian youth (Ho'ouna Pono) using community-based     participatory research principles and practices, and to test the efficacy and adoption of the     full intervention across all middle/intermediate schools on Hawai'i Island. These purposes     will be accomplished through three specific aims. AIM 1 (Year 1) is to complete the Ho'ouna     Pono drug prevention curriculum initially developed and validated in a NIDA-funded     pilot/feasibility study (R34 DA031306). To date, five professionally filmed video vignettes     depicting drug-related problem situations specific to rural Hawaiian youth and seven     interactive classroom lessons have been created, implemented in randomly selected     intervention schools, and preliminarily evaluated using a pre-test, post-test control group     design. Aim 1 enhances and builds upon this work by producing two new video vignettes,     re-editing a Behind the Scenes video, developing new classroom curricular components, and     synthesizing the new content with the existing curriculum. AIM 2 (Years 2-3) is to evaluate     the fully conceived curriculum across all middle/intermediate schools on Hawai'i Island (N =     15) using a dynamic wait-listed control group design (Brown, Wyman, Guo, & Peña, 2006). Using     this design, schools will be randomly assigned to four cohorts, and cohorts will be randomly     assigned to receive the curriculum at designated times staggered across the two-year     evaluation period. All participating youth will be measured at six designated time points     across the two-year evaluation period. Because of the staggered implementation of the     curriculum, intervention effects will differ by cohort, and earlier time points will include     control schools for the initial cohorts receiving the intervention. All participating youth     will receive pre-tests prior to curriculum implementation and post-tests upon curriculum     completion, with youth attending schools in Cohorts 1-3 receiving follow-up evaluations. AIM     3 (Year 4) is to assess community, systemic, and curricular factors related to the     implementation, adoption, and sustainability of the curriculum within public     middle/intermediate schools on Hawai'i Island.      The present study is the result of seven consecutive years of NIDA-funded pre-prevention and     translational pilot/feasibility drug prevention research focused on rural Hawaiian youth and     communities. The overall outcome of this study will be an empirically supported, culturally     grounded drug prevention curriculum relevant to Native Hawaiian and Pacific Islander youth.     This study addresses the lack of prevention interventions for Native Hawaiians and other     Pacific Islanders (NHOPIs) and indigenous youth populations, and directly contributes to the     development of an indigenous prevention science (Okamoto, Helm, et al., 2014). It has     implications for informing indigenous, Pacific Islander, and rural health disparities and     health equity promotion.   "
12705|NCT03119116|"     Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause     stroke, need to take blood thinners to prevent it. It is important to prescribe the correct     dose of blood thinners to the right patients to ensure the treatment works however avoiding     complications. In the recent years, new blood thinners have been available; they require less     laboratory tests and fewer visits to a doctor compared to older therapies. This study will     look at how the general practitioners in the UK prescribe blood thinners according to the     instructions given by the product manufacturer. We will use primary care data that is     routinely collected by the general practitioners about their patients but without any     possibility to identify individual patients. The results will help us to understand the     magnitude of deviation from instructions in order to ensure that the patients benefit from     the treatment.   "
12706|NCT03119103|"     Apnea, a cessation in breathing is critical condition that affects the person regardless of     age.      In infants, an apneic state occurs when there is an absence of respirations for 20 seconds     (Alvaro & Rigatto, 2012). In adults, there is a correlation between sleep apnea with     increased risks of cardiovascular health problems (Wimms, Woehrle, Ketheeswaran, Ramanan, &     Armitstead, 2016; Wu, Yuan, Wang, Sun, Liu, and Wei, 2016; Hao, Xiandao, Li, Jingwu, Jinghua,     & Yongxiang, 2016).      The purpose of this proposed study is to investigate the reliability of a smart bed sheet's     ability to detect physiological signals such as respiratory patterns.      The study's goals are two-fold: 1) to determine the sensors' ability to detect patterns with     regards to input signals, and 2) to evaluate the efficacy of pressure sensor signals     collected in relaying respiratory rate and respiratory patterns to monitor different     thresholds of respiration rate and pattern which may include critical parameters dangerously     outside of life sustaining norms.   "
12707|NCT03119090|"     The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of     blood and urine biomarkers to imaging parameters of ventricular mechanics.   "
12708|NCT03119077|"     This study will be conducted in a single center, double-blind with 6 dose escalation groups     to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of     BAY1161116.   "
12709|NCT03119064|"     New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic     temozolomide is a standard treatment option but has, at best, modest activity. The     nanoliposomal irinotecan may be much more active than the parent compound irinotecan since     nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I     study will establish the MTD of the combination of nanoliposomal irinotecan in combination     with temozolomide safety and preliminary clinical efficacy of the combination of     nanoliposomal irinotecan and metronomic temozolomide.   "
12712|NCT03119025|"     Clearance of HCV infection requires early and multi-specific HLA class I restricted CD8+ T     cell and class II restricted CD4+ T cell responses to both structural (Core) and     non-structural HCV proteins (NS3, NS4A, NS5A, NS5B). Dendritic cells (DCs) are professional     antigen-presenting cells that link innate and adaptive immune responses, and play a major     role in priming, initiating, and sustaining strong anti-HCV T cell immune responses.      The general objective of this study is to evaluate safety, feasibility and clinical efficacy     of therapeutic vaccination in genotype 1 HCV patients using autologous DCs pulsed with     recombinant HCV-antigens (Core and NS3). Expected effects: DC vaccination induces     Core/NS3-specific immune response and reduces viral load in patients with chronic     HCV-infection.   "
12713|NCT03119012|"     This study aimed to compare the efficacy and safety of P2Y12 inhibitor monotherapy versus     extended dual antiplatelet therapy (DAPT) following 12-month of DAPT in patients undergoing     percutaneous coronary intervention (PCI) with bioresorbable scaffold (BRS)   "
12714|NCT03118999|"     The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3     oils after a single-dose administration in healthy volunteers   "
12715|NCT03118986|"     Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during     cancer treatment according to children and their parents. Most children receiving     hematopoietic stem cell transplant (HSCT) conditioning experience CINV despite receiving     antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a     track record of safe use in children with psychiatric illness, does not interact with     chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard     antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving     high dose cyclophosphamide for hematopoietic stem cell transplantation (HSCT) conditioning.   "
12716|NCT03118973|"     Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic     septotomy vs. double wire technique for achieving biliary access in patients who fail initial     cannulation at ERCP.   "
12717|NCT03118960|"     This non-randomized clinical study will compare pressure injuries and the change in pressure     injuries for subjects who are placed on the Freedom Bed compared to those placed on a     standard Group II Low Air Loss/Alternating Pressure Mattress in the Ventilator Unit at     Northeast Center for Rehabilitation and Brain Injury. Additionally, the incidence of     pneumonia, urinary tract infections, circulatory performance, sleep deprivation and caregiver     self-perception on performance will be monitored and documented.   "
12718|NCT03118947|"     To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in     subjects with probable AD who have symptoms of agitation and aggression   "
12719|NCT03118934|"     The purpose of this study is to compare an alternative fitting guide to a current fitting     guide for optimizing contact lens parameters and determining contact lens prescription.   "
12720|NCT03118921|"     Evaluation of the tolerance and acceptability of the virtual representation of its body     image.   "
12721|NCT03118908|"     To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart     B by women with a typical (without complications) form of climacteric syndrome, with mild to     moderate symptoms.   "
12722|NCT03118895|"     A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt     Chromium coronary stent system in patients at high risk of bleeding   "
12723|NCT03118882|"     The main study objective is to determine the feasibility and impact (effectiveness) of     intervention models for lifestyle changing (diet and physical activity) on health outcomes.     Women 50 to 54-year-old attending the local breast cancer screening and 58-year-old people     (both sexes) undergoing colorectal cancer screening are invited to participate in the study.     Compliers are randomized into 3 intervention groups (Diet, Physical Activity, and Physical     Activity and Diet) and into the 'usual care' Control group. Biological sampling (blood and     saliva) is collected from all participants. All participants undergo also anthropometric     measurements and fill in a self-administered validated questionnaire on their dietary and     physical activity habits. All enrolled subjects receive a booklet with basic information     about diet and physical activity. Subjects randomized to the 3 intervention groups are also     offered one theoretical and three training courses. The courses are specifically designed for     the different interventions proposed and aimed at reinforcing the educational counseling and     at supporting behavioral changes.      Follow-up is performed at 8 (intermediate follow-up) and 12-14 (final follow-up) months for     repeating anthropometric measurements and questionnaire filling and blood sampling (at the     final one).   "
12724|NCT03118869|"     The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include     bronchodilation, bronchoprotection. The b2-adrenoceptor (b2AR) mediates the physiological     responses in the airway, which include bronchodilation, bronchoprotection, Enhanced     mucociliary clearance.      The b2AR gene is located on chromosome 5q31-q32, a region that is genetically linked to     asthma and related phenotypes. There are three best known polymorphisms in the coding region     of the b2AR gene that can modulate the function of the receptor.   "
12725|NCT03118856|"     To assess the accuracy of predicting histology of colorectal polyps with electronic     chromoendoscopy.   "
12726|NCT03118843|"     The primary objectives of this study are to determine the efficacy of treatment with     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks     as measured by the proportion of participants with sustained viral response 12 weeks after     cessation of treatment (SVR12) and to evaluate the safety and tolerability of treatment with     SOF/VEL/VOX FDC.   "
12740|NCT03118661|"     The goal of this proposal is to determine the effect of maraviroc when it has been a part of     the antiretroviral (ART) regimen given immediately after allogeneic hematopoietic cell     transplant (allo-HCT) for HIV-1 infected participants who have a hematopoietic malignancy or     other underlying disorder requiring an allogeneic transplant. Maraviroc has been given in     practice to alleviate symptoms of graft vs. host disease (GvHD). Given its mechanism of     action, it may also have an effect on the reservoir size of HIV-1 in infected patients. This     study will inform potential future studies, evaluating the effect of this approach on the     incidence and severity of GvHD, and determining its effect on HIV-1 reservoir.   "
44650|NCT02701270|"     The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products     1 and 2 are digested using glycaemic and insulinaemic response as markers.   "
12727|NCT03118830|"     Patients will be divided into two groups Group A; patients using long protocol and freeze all     embryos Group B; patients using antagonist protocol with fresh embryo transfer Patients will     be carefully chosen according to a strict inclusion and exclusion criteria after meticulous     revision of patient files.      In the long protocol, daily SC injection of Triptorelin :Decapeptyl 0.1 mg (Ferring,     Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued     till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start     criteria of thin endometrium < 5 mm and low E2 < 50 and LH < 5IU/l with either HMG(Menogon;     Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300     IU/day according to women age, day 3 FSH,AMH and previous gonadotropin response then     adjustment of the dose according to ovarian response monitored by serum E2 and ultrasound     evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on     alternate days according to the ovarian response to treatment starting on treatment cycle day     (6) for folliculometry and endometrial thickness and pattern.      Triggering by HCG 10000 IU IM (Pregnyl, Organon, the Netherlands) when 2 or more follicles     have 18 mm as a mean diameter .      Flexible GnRH antagonist protocol was done with daily s.c administration of cetrorelix 0.25     mg (Cetrotide, Merck Serono, Darmstadt, Germany) started when one or more of the following     criteria were achieved: (i) one or more follicle reached 14 mm diameter; (ii) The level of     serum E2 reached 600 pg/ml; and (iii) The level of serum LH levels reached 10 IU/l . Daily sc     rFSH (Gonal-f; Merck Serono , Darmstadt, Germany) injections was started on 2nd day of the     cycle in the antagonist protocol. Continuation of rFSH and GnRH antagonist daily until     triggering day was done.   "
12728|NCT03118817|"     This study evaluates the anti-tumor efficacy and safety of single agent HM95573 administered     in patients with solid tumors harboring mutations in either BRAF, KRAS or NRAS gene.   "
12729|NCT03118804|"     To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation   "
12730|NCT03118791|"     Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes.     Increasing evidence from human epidemiological and dietary intervention studies suggests that     anthocyanins may have cardiovascular health benefits. The present study aimes to investigate     whether pure anthocyanin consumption improves endothelial function in healthy individuals and     if these effects are dose-dependent.   "
12731|NCT03118778|"     This is a descriptive retrospective database analysis study in using database. All patients     with a physician PPI prescription will be selected to estimate the PPI inappropriate use.   "
12732|NCT03118765|"     Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via     Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).   "
12733|NCT03118752|"     The investigators will complete a pragmatic randomized trial (N=260) of the 26-week blended     collaborative care (CC) intervention compared to enhanced usual care (eUC) in patients     admitted for acute coronary syndrome (ACS) or heart failure (HF) found to have current     depression, generalized anxiety disorder (GAD), or panic disorder (PD). The CC intervention     will use a novel three-pronged approach to these high-risk patients. Care managers will     provide centralized care coordination and specific interventions targeting: (1) the     psychiatric disorders, (2) cardiac health behaviors, and (3) the cardiac illness. The primary     study outcome will be physical function at 26 weeks, measured by the Duke Activity Status     Index (DASI), given links between function and new cardiac events. The investigators will     also examine effects on numerous other outcomes important to patients and healthcare systems.      Specific Aim 1 [patient-centered outcomes—primary aim]: To compare between-group differences     in the CC and eUC conditions on improvements in physical function, health-related quality of     life, mental health, patient satisfaction, and other key patient-reported outcomes at 26 and     52 weeks.      Specific Aim 2 [adherence and medical outcomes]: To compare between-group differences on     health behaviors (physical activity, diet, smoking, medication adherence) and major adverse     cardiac events.      Specific Aim 3 [cost]: To compare healthcare costs between groups and assess the     cost-effectiveness of CC.      Hypotheses: The investigators expect this bolstered CC program to be associated with superior     improvements in physical function, health-related quality of life, patient satisfaction, and     adherence at 26 weeks, with promising effects on major adverse cardiac events. The     investigators likewise expect the intervention to be cost-effective     (<$10,000/quality-adjusted life year) over the study period.   "
12734|NCT03118739|"     The purpose of this clinical research study is to evaluate signals of potential clinical     benefit of the combination of RDEA3170 and Febuxostat in lowering concentrations of     circulating uric acid and thus improving kidney or cardiovascular status of patients with     hyperuricemia, albuminuria, and Type 2 diabetes (T2DM).   "
12735|NCT03118726|"     This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC)     on implementing immediate postpartum long-acting reversible contraception programs. All     hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be     eligible to participate in the NPMC program evaluation. The study will evaluate the     components of this implementation program at several New Mexico hospitals using a stepped     wedge design,with components being introduced to each hospital one at a time   "
12736|NCT03118713|"     The primary purpose of this study is to assess the renal protective effect of ipragliflozin     in combination with metformin on the percent change of UACR from baseline to 24 weeks against     glimepiride in combination with metformin in type 2 diabetes mellitus patients with     albuminuria. The secondary purpose of this study is to assess the efficacy, safety and impact     on quality of life (QoL) of ipragliflozin in combination with metformin against glimepiride     in combination with metformin in type 2 diabetes mellitus patients with albuminuria.   "
12737|NCT03118700|"     The purpose of this study is to examine the acute effect of continuous and aerobic interval     exercise on postexercise central BP response in men with an elevated blood pressure.   "
12738|NCT03118687|"     The Human Immunome Program is a large-scale, open-source effort seeking to fill a major gap     in our knowledge of the immune system. The power of the immune system to fight disease lies     in its ability recognize and adapt to an astonishing range of threats from viruses, parasites     and bacteria to cancer cells. Underlying this ability is a vast but specific set of genes and     molecular structures known as the human immunome, or the parts list of the immune system.     This study aims to decipher the genetic sequences that make up this part list and link it to     information about a person's microbiome composition and characteristics such as health     history, race, and demographics over time. This information, made freely available to the     public for use in research in de-identified form, will allow investigators to answer a wide     variety of different questions about immune system function. This could transform how we     diagnose, prevent and treat disease though the identification of new biomarkers while     enabling highly targeted, computationally designed vaccines and therapies that reduce time     and risk of product development.   "
12739|NCT03118674|"     In the medical literature there case reports that Harvoni improves symptoms in patients with     PCT. However, this has never been systematically tested. Therefore, the purpose of this study     is to assess whether Harvoni alone is an effective therapy of active PCT in patients with     Chronic Hepatitis C.   "
12961|NCT03115775|"     To conduct a randomized, double-blind, controlled clinical trial to determine the independent     and combined effects of dietary conjugated linoleic acid (CLA) and vitamin D supplementation     on anabolic signaling, the expression of growth regulatory factors, and muscle protein     turnover in older adults.   "
12741|NCT03118648|"     The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb     after stroke i six months after patient discharge from rehabilitation center. The level of     functional recovery at rehabilitation discharge could better guide rehabilitation strategies     to enhance independence and participation in daily life.      This study aims to determine, in patients after stroke, the optimal affected upper limb     recovery threshold at rehabilitation discharge to predict spontaneous level of use of     affected upper limb in activities of daily living, six month later.      This study is a multicentric prognostic prospective cohort study. The main prognostic     variable will be the Action Arm Test (ARAT, Lyle, 1981) score at rehabilitation discharge and     the predicted variable will be the Motor Activity Log - 28 (Taub et al. 1993) score at 6     months post discharge.   "
12742|NCT03118635|"     Convergent findings from several studies document that children, especially those who are     already overweight or obese or from racial / ethnic minority groups, are at risk for     accelerated weight gain during the summer months. Therefore, this project is comprised of     three separate community-based interventions designed to increase access to healthy meals and     physical activity opportunities to minimize excess summer weight gain in elementary school     children from a diverse, low-income Rhode Island community. Specifically, we will complete a     quasi-experimental study in which we will design and deliver a physical activity intervention     in conjunction with the Summer Food Service Program (SFSP) to 50 children living in a     low-income, urban community. We anticipate that the addition of physical activity programming     to the SFSP, a federal program funded by the USDA which reimburses states for serving lunch     meals to children during the summer in communities where at least 50% of students are     eligible for free or reduced-price school meals, will increase both the acceptability and     effectiveness of the SFSP and affect 1) physical activity levels, 2) sedentary behavior, and     3) diet quality. The primary outcome (change in BMI z-score) will be compared between the 50     kids enrolled in the active intervention and 50 children enrolled in the control condition,     both recruited from the same community.   "
12743|NCT03118622|"     Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in     pediatric patients   "
12744|NCT03118609|"     The Understanding Needs Project is designed to gain an understanding of the needs of     informal caregivers. Researchers have designed a survey to highlight activities of daily     living involved in the caregiving role, pain related to caregiver, and potential services     desired. The initial phase of the study will consist of a focus group of informal caregivers     to discuss current needs. The survey will then be refined based on knowledge gained from the     focus group, and feedback from expert researchers. The refined survey will then be     disseminated to caregivers throughout the country.      Please click on the following anonymous link to participate:     https://chhscolostate.co1.qualtrics.com/jfe/form/SV_54j83BQSItMuoUB   "
12745|NCT03118596|"     The study aims to establish which of the two second generation Supraglottic Airway Devices,     the I-gel or the the laryngeal ask airway (LMA) Protector, is best suited to be used as a     conduit to fibreoptic bronchoscope assisted tracheal intubation. The primary outcome of this     will be the time to complete the tracheal intubation.   "
12746|NCT03118583|"     The goal of this study is to assess the effects of a dietary supplement on fasting     lipoprotein lipids and a marker of inflammation in men and women with levels of low-density     lipoprotein cholesterol above desirable levels.   "
12747|NCT03118570|"     The purpose of this study is to select a suitable dose of BPS804 by comparing it with a dummy     treatment and measuring the strength/quality of bone using a special type of CT scanner.     Participants will be treated for 1 year.   "
12748|NCT03118557|"     Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and     long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age?   "
12749|NCT03118544|"     The is an observational, prospective study to evaluate the effect of the DyeVert System on     contrast volume administration in patients undergoing clinically-indicated chronic total     occlusion (CTO) percutaneous coronary intervention (PCI)   "
12750|NCT03118531|"     To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous     transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm     Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.   "
12751|NCT03118518|"     To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™     Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial     fibrillation, without the requirement that the subjects be drug refractory.   "
12752|NCT03118505|"     The purpose of this study is to obtain safety and effectiveness data on the investigational     device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use     in this indication. The study information may be used for a potential pivotal study design.   "
12753|NCT03118492|"     This pilot clinical trial studies the side effects of combination chemotherapy, total body     irradiation, and donor blood stem cell transplant in treating patients with secondary     myelofibrosis. Drugs used in chemotherapy work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors.     Giving combination chemotherapy and total body irradiation before a donor blood stem cell     transplant helps to stop the growth of cells in the bone marrow, including normal     blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets.   "
12754|NCT03118479|"     The investigators are doing this research study to look at the relationship between     testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar     levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).      The investigators hypothesize that normalizing testosterone levels in men with IHH enhances     insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid     profile.   "
12755|NCT03118466|"     This research study is evaluating how a drug called lenalidomide, given in combination with     the standard chemotherapy regimen of Mitoxantrone, Etoposide, and Cytarabine, commonly     referred to as MEC, works in individuals with either relapsed or refractory AML   "
12756|NCT03118453|"     Implementation of a behavioral medicine approach in physical therapy for patients with     persistent musculoskeletal pain is in accordance with the state of science. Translation of     research into clinical PT practice is challenging and may demand active implementation     strategies.      The aim is to evaluate the implementation of a behavioural medicine approach for patients     with persistent musculoskeletal pain concerning sustainable health benefits and sick-leave,     as well as the cost-effectiveness of the implemented treatment.      Treatment outcomes for patients from two groups of physical therapists in primary care will     be compared. In one group active implementation strategies have been employed, and in the     other (control) passive implementation strategies during a 6-months intervention period.     Patients are recruited during one-year after the implementation period.      The short and long-term effects of the implementation of the BM approach in PT treatment on     patients' sick-leave, activity and participation, and health related quality of life will be     compared to the patients from control condition clinics. The cost-effect and cost-benefit of     an implementation of a behavioral medicine approach in physical therapy is evaluated from the     perspective of the health care organization and society.   "
12757|NCT03118440|"     This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX     zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to     performing single-chamber pacemaker implantation.   "
12758|NCT03118427|"     This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX     zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to     performing double-chamber pacemaker implantation.   "
12759|NCT03118414|"     The objectives of this study were to 1) compare balance of the elderly by Berg Balance Scale     (BBS) and Timed Up and Go Test (TUG) among physical exercise, virtual reality, brain exercise     and control groups after intervention, 2) compare cognitive function of the elderly by using     Timed Up and Go Cognitive (TUGC) and Montreal Cognitive Assessment (MoCA) among physical     exercise, virtual reality, brain exercise and control groups after intervention, 3) compare     muscle strength of elderly by 5 Times Sit-To-Stand Test (5TSTST) and Hand Grip Strength (HG)     among physical exercise, virtual reality, brain exercise and control groups after     intervention, 4) compare fear of falling by using Fall Efficacy Scale-International (FES-I)     among physical exercise, virtual reality, brain exercise and control groups after     intervention, 5)investigate the perspective of exercise among physical exercise, virtual     reality, brain exercise and control groups after intervention.   "
12760|NCT03118401|"     As they age, the intestinal elimination function can be altered by external factors. Sleeping     is also a vital need for maintaining health. Sleep time varies with age (from 18h / day for     an infant to 7h30 on average for an adult) and sleep disorders increase with age (INSERM     source). In our study, the night is from 9 pm to 7 am, corresponding to the working hours of     the night shift. Between 42% and 50% of episodes of wakefulness of more than 4 minutes in     EHPAD are due to noise, light or the practice of care related to incontinence. 87% of all     incontinence care practices have been associated with wake-up episodes. A personalized day     care program would allow residents to improve the quality of their sleep by minimizing stools     at night and therefore interventions by caregivers.      The ritual of stools, can be defined as the set of rules to observe to defecate in good     physiological, physical conditions:        -  Be in a suitable place for intestinal elimination: personal bathroom preferably on the          toilet or on a pierced chair that will perhaps be more secure and comfortable with the          armrests. The position to be taken is important.        -  Propose a small bench to put under the feet to raise the knees higher than the hips and          increase the abdominal pressure.        -  Preserve the visual and auditory intimacy of the resident at the time of defecation.          Failure to do so may result in the person repressing his desire to defecate.        -  Allow the resident the time needed on the toilets the doorbell at hand and with the          assurance that the caregiver will come back in a short time. Do not press it and do not          forget it, privilege the autonomy and check that there is toilet paper.      The establishment of the stool ritual is not intended to reduce the amount of stool by day,     but it aims to postpone the nighttime exemption on the day, and does not prevent the stool     emission to other times of the day or night.   "
12761|NCT03118388|"     This randomized controlled trial (RCT) compared the efficacy between the Social Enterprise     Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental     illness.      Methods: Non-probability quota sampling sampling was used to recruit 72 homeless youth from     one agency, who were randomized to the SEI (n=36) or IPS (n=36) conditions.   "
12762|NCT03118375|"     The purpose of this study is to assess the benefit of new super-power bone-anchored hearing     aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and     single-sided hearing loss when they are unable to use or receive limited benefit from     traditional hearing. Until recently, BAHAs were only recommended to people with up to a     moderate hearing loss. New super-power BAHA processors may be able to help people who     previously were not candidates for BAHAs or received limited benefit from them. The     information collected in this study may lead to improved evaluation of and expanded treatment     options for people considering BAHA. Different types of hearing tests will be used to compare     the devices.   "
12763|NCT03118362|"     Balanced solutions with low chloride concentration could represent an alternative to high     chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e.     acetate and/or gluconate). However, acetate has been associated with alteration of cardiac     function when used as buffer in dialysate when high acetate concentrations are used and could     promote the development of metabolic acidosis if it accumulates. Therefore, the safety of     such solutions remains poorly explored. Because critically ill patients receive large amount     of fluid during the early phase of resuscitation, large amount of acetate are to be     administrated if such solutions are used. While acetate-containing solutions have been     suggested to be safe in this setting, studies are still lacking regarding clearance and     accumulation in critically ill patients.      It is expected to include 28 patients, the objective to analyze the data of 20 patients.   "
12764|NCT03118349|"     Open label, nonrandomized, dose-escalation with cohort expansion trial of MVT-5873/MVT-1075     in subjects with previously treated, CA19-9 positive malignancies (e.g., pancreatic     adenocarcinoma).   "
12813|NCT03117712|"     Postoperative delirium is an acute and fluctuating state of confusion and disorientation with     an incidence of 25-70% after cardiac surgery. Possible reasons for this multifactorial     complication are hypoperfusion, cerebral microembolization and inflammatory response, which     eventually lead to regional or global imbalance between cerebral oxygen demand and supply.     Adequate cerebral blood supply depends sufficient blood supply via the vertebral arteries and     the internal carotid arteries. The aim of this preliminary study is to investigate if     patients who develop delirium after open-heart surgery show differences in their cerebral     blood flow during cardiopulmonary bypass (CPB) in extracerebral arterial vessels compared to     those patients without delirium.   "
12765|NCT03118336|"     There is substantial evidence supporting the fact that ectopic fat accumulation is an     important contributor to type 2 diabetes complications and cardiovascular risk [1].     Epicardial adipose tissue (EAT), located between the myocardium and the visceral layer of the     pericardium has been associated with atrial fibrillation and with coronary artery disease [2,     3] and its abundance predicts the number of cardiac events within 8 years [4]. In addition,     myocardial steatosis has been shown to be an independent predictor of diastolic dysfunction     [5] [6]. Furthermore, in type 2 diabetic patients, bariatric surgery can reduce cardiac     ectopic fat accumulation and improve cardiac function [7] [8]. When added to standard care,     10 or 25 mg/d of empagliflozin, an inhibitor of sodium-glucose cotransporter 2 (iSGLT2),     significantly reduces the risk of death, cardiovascular death, and hospitalisation for heart     failure among individuals with type 2 diabetes and established cardiovascular disease when     compared to placebo [9]. The mechanisms of empagliflozin-improved cardiovascular outcomes in     type 2 diabetic patients at high risk of cardiovascular events are not known. We hypotheses     that empaglifozin could modulate cardiac ectopic fat and cardiac metabolism in obese type 2     diabetic patients.   "
12766|NCT03118323|"     The aim of the present study is to determine the monetary value of endodontic treatment     (primary root canal treatment) compared to the alternative treatment options, such as     extraction with or without subsequent insertion of a dental implant or placement of a fixed     dental prosthesis.   "
12767|NCT03118310|"     The impact of popular diets on liver-related health is unclear. In this randomized,     controlled trial, patients with NAFLD will be randomized to one of two popular diets or a     placebo diet.   "
12768|NCT03118297|"     The subdermal etonogestrel (ENG) implant, a long-acting reversible contraceptive (LARC)     method, is among the most effective forms of reversible contraception and thus, an important     tool in the quest to reduce unintended pregnancy. However, despite overall increases in LARC     use in the United States from 1.5% in 2002 to 7.2% in 2011, and 11.6% most recently in 2015,     implant use continues to make up a small proportion of LARC use. While evidence to explain     this low uptake of implants is lacking, one potential reason is patient and provider concerns     about unpredictable bleeding.      As a result of this, many studies have been performed in attempts to discover therapies for     unscheduled bleeding in progestin-only contraceptive users. Some of these studies include     those investigating selective progesterone receptor modulators, such as mifepristone and     ulipristal acetate (UPA), which did find some benefit. Although a previous study showed mixed     benefit, the investigators feel that this medication has demonstrated both biologic     plausibility as well as clinically important outcomes. This previous study may not be     entirely translatable to the proposed research as therapies were used for different     indications (prophylaxis vs. treatment) and different progestins and delivery systems were     studied. Therefore, the investigators believe UPA should not be discounted as a potential     therapy. UPA may provide an additional safe and effective option for treatment of irregular     bleeding with implants in women. In addition, UPA is currently available in outpatient     pharmacies in the U.S. as a single 30mg oral tablet.      The investigators propose to investigate UPA for the treatment of unscheduled and troublesome     bleeding in ENG implant users.   "
12769|NCT03118284|"     Urinary [Foley] catheters [tubes] are commonly placed in patients undergoing surgery;     approximately 25% of surgical patients will receive one. Among patients who receive urinary     catheters, discomfort associated with the Foley catheter is common; between 47-90% of     patients experience catheter related bladder discomfort [CRBD]. Presence of a foreign object     in the bladder even for short periods of time may result in symptoms such as a burning     sensation, pain in the lower abdomen, muscle spasms and a sense of urgency to urinate. There     is some evidence that suggests that hospital-acquired urinary tract infections are directly     related to catheter placement, which causes mechanical damage and local inflammation to the     urethra and the bladder. Based on research conducted on a similar mechanism where an airway     tube is inserted into a patients throat for delivery of general anesthesia - we hypothesize     that CRBD is related to injury and inflammation caused by the catheter placement and that     this occurs in a sterile environment.   "
12770|NCT03118271|"     To compare the effect of lumbar traction, lumbar spinal manipulation and lumbar surgery in     the treatment of LDH.   "
12771|NCT03118258|"     Every year, in France, 3 000 women are diagnosed for cervical cancer, and 1 000 die each     year. The incidence of this cancer is very inequal: recent studies found regional, social and     economical inequalities.      Currently, in France, the pap-smear test is the reference in prevention for cervical     neoplasia (CIN) and cancer screening. Screening and treatment allowed to reduce the incidence     and the mortality by cervical cancer by half, since the two last decades. But many women are     still not reached by prevention programs, especially precarious women. In 2013, Doctors of     the World France evaluated that almost 70% of women aged from 25 to 65 years coming in its     medical center had never benefit of a pap-smear test.      The objective of this study is to compare the rate of participation in the pap-smear     screening with the proposition of a prevention consultation about sexual and reproductive     health associated or not with the proposition of a vaginal Human Papillomavirus (HPV)     self-sampling.   "
12772|NCT03118245|"     Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After     anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started.     Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for     insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be     compared between two groups.   "
12773|NCT03118232|"     This is a cluster-randomized trial of nursing homes to assess whether decolonization with     routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce     hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant     organism (MDRO) prevalence. The comparator arm will be routine bathing care.   "
12774|NCT03118219|"     Involuntary childlessness is experienced as emotionally stressful, however psychosocial     counseling is not always available on the spot. Aim of this RCT study is to examine the     efficacy and acceptance of a psychological low-dose online intervention for couples in     reproductive treatment.   "
12775|NCT03118206|"     To compare the effect of lumbar spinal manipulation, physical therapy and surgical management     in the treatment of lumbar spinal stenosis.   "
12871|NCT03116958|"     The purpose of this study is to improve CPAP treatment compliance of Obstructive Sleep Apnea     Syndrome using an integrated telemedicine platform (MyOSA system)   "
12776|NCT03118193|"     According to the WHO, major depressive disorders have become the second worldwide cause of     disability. Treatment, long-term medication, leads to frequent resistance (up to 40%).      Establishing a cerebral molecular signature of depression is not feasible in humans (need for     cerebral samples). The alternative is to use peripheral biological samples (blood, urine,     saliva).      Metabolomic is the integrated and quantitative study of all the metabolites of a biological     system. This aims to define the metabolic status of an organism for a particular condition.      Metabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.)     and are detected by:        -  liquid or gas chromatography coupled to mass spectrometry (LC-MS, GC-MS),        -  proton nuclear magnetic resonance (1 H-NMR). The biomarkers resulting from these studies          have become important diagnostic criteria, measured objectively and evaluated as          indicators of a normal or pathological state, or even predictors of treatment efficacy.      This approach allows the discovery of biomarkers that best describe the status of a disease     for better understanding and are usable in a context of individualized medicine, with effects     on clinical practice and management.   "
12777|NCT03118180|"     A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B     cell lymphoma.   "
12778|NCT03118167|"     A double-blind randomized controlled trial (RCT) was conducted in current human study. This     study aims to investigate the intervention effect of AOB-w on the short-term exposure and     toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing,     in Chinese adolescents.   "
12779|NCT03118154|"     This study will compare subjects with a history of pelvic or menstrual pain diagnosed with     endometriosis treated at Clear Passage with untreated control subjects. The treatment group     will be a retrospective chart review; the control subject group will be a prospective     questionnaire based study.      The study will assess the changes in pain experienced by subjects treated with manual therapy     at Clear Passage to untreated subjects with endometriosis.   "
12780|NCT03118141|"     The purpose of this randomized clinical trial is to compare the efficacy and safety with     transfer of embryos selected by next generation sequencing (NGS) versus conventional     morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will     be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst     transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative     live birth after transfers of up to 3 single blastocycsts in both groups.   "
12781|NCT03118128|"     Metformin's Antitumor activity were identified from differens diabetic patients trials,     mainly associated to its mechanism of action and protein - kinase AMPK (AMP-activated protein     kinase) activation. According to Cancer and Diabetes International Consensus from 2012,     diabetes increases the risk for developping cancer and metformin has an protector effect     against cancer cells and has an impact on overall survival.      Chemotherapy drug resistance induces treatment fail in oncology. Metformin increases AMPK     levels, blocks PI3K (phosphatidylinositol 3- kinase)/ AKT /mTOR(mammailian Target of     Rapamycin) pathway but few evidence associated with drug resistance gene expression.      This is an, experimental one-center study that pretends to stablish the effect of adding     metformin 850 mg PO three times a day over the multi-drug resistance gene expression (ABCB1)     in de novo Acute Lymphoblastic Leukemia in one 7-days cycle with prednisone as pre-treatment-     and on the induction remission treatment.   "
12782|NCT03118115|"     MONITRANS project consist of developing a monitoring technology of post-operative breast     reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by     monitoring patients at home.      Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare     phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water     intake in the plasma compartments. The investigator would like to prove, by this research     project, that they are able to detect ischemia via bioimpedance technology.      During abdominal free flap harvesting for breast reconstruction, there are few minutes where     the flap is clamped because of anastomosis on the recipient vessels. The investigators would     seize the opportunity of this step, which is similar to vascular thrombosis, to measure     bioimpedance variations.      Therefore they would like to measure variations of the flap bioimpedance before and after     vascular section. Another purpose consists of developing an algorithm which will detect     postoperative thrombosis.   "
12783|NCT03118102|"     The investigators aim to investigate the effect of operating room noise on anesthetist     hearing   "
12784|NCT03118089|"     The health risks and costs associated with malnutrition can be significantly reduced if     symptoms are recognized early and treated effectively. Oral nutritional supplements (ONS)     have been shown to increase nutrient intakes and maintain or improve nutritional status and     functional outcomes in patients in a variety of settings. However despite this it is     frequently reported that compliance to ONS, which are often milk based drinks, is poor. The     aim of the present study is to assess the effectiveness of a new biscuit style nutritional     supplement in the management of malnutrition.      The study is a randomized controlled eight-week intervention study. Suitable participants     currently being prescribed ONS and who meet the study inclusion and exclusion criteria, will     be identified by either staff in care facilities, Registered Dietitians or by General     Practitioner (GP) surgeries. Participants (n=80) will be stratified based on BMI and gender     and randomly assigned to either the biscuit ONS group (n=40) or to remain on their existing     ONS prescribed as part of their standard care practice (n=40). Changes in anthropometry,     functional status, nutritional intake and appetite, general health, gastrointestinal symptoms     and biochemistry (correction of nutritional deficiency), as well as compliance and     acceptability of ONS will be assessed between week 0 and week 8. Participants will also be     visited mid-intervention (week 4) to ensure well-being and assess compliance.      This work is funded by Calerrific Ltd. and seeks to determine if the new biscuit style     nutritional supplement could be used as an alternative to, or in conjunction with, existing     ONS to improve compliance and aid the recovery of malnourished patients.   "
12910|NCT03116438|"     The purpose of the study is to evaluate the safety and performance of the CADence device by     comparing it to the results obtained from standard coronary angiography. The CADence device     collects acoustic (sound) data from locations on the chest for the purpose of identifying     coronary artery turbulence, which may be indicative of coronary artery disease.   "
12785|NCT03118076|"     Peripheral nerve block has been recommended as the technique for postoperative pain     management because it provides equivalent analgesia but with fewer adverse effects than     either systemic or epidural analgesia.      The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the     duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and     shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve     blocks has not been described.      In this study, we investigated the effect of adding dexmedetomidine as additive in femoral     and common peroneal nerve blocks for postoperative analgesia.      Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or     anterolateral thigh flap reconstruction, were divided into two groups in a randomized,     double-blind fashion. In Group Ropivacaine (Group R), nerve blocks were administered with     0.3% ropivacaine. In Group Ropivacaine + Dexmedetomidine (Group RD), nerve blocks were     administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the     onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood     pressure, SpO2, sedation level, the duration of motor blocks.   "
12786|NCT03118063|"     Contextualization: Trigger points are muscle nodules found in muscles. We can observe five     different types of trigger point, in clinical practice two of them stand out, the active     trigger point; Which is painful; And latent; Asymptomatic; Both of which are sensitive to     palpation. Once the individual present these muscle nodules can develop pain and motor     dysfunction. Studies indicate that the prevalence of trigger points is 95% of individuals     with chronic musculoskeletal pain, but this prevalence is not yet clear in individuals with     low back pain.      Objective: To compare the pain and function levels of patients with acute and chronic low     back pain who, when asymptomatic, had trigger points compared to the pain and function levels     of patients with acute and chronic low back pain who, when asymptomatic, had no trigger     points.      Study design: Cohort study, two arms, blind evaluator, prospectively enrolled at baseline.      Location: This research will be conducted in the physiotherapy department at the     Rehabilitation Center of the Brotherhood of Santa Casa de Misericórdia de São Paulo (ISCMSP).      Patients: 400 asymptomatic individuals Follow-up: Asymptomatic individuals will be assessed     at baseline and over 3 years. You will be asked to contact the research department within 6     weeks of low back pain (acute) and after 12 weeks of low back pain (chronic). Participants     will be allocated to two groups, trigger point group (n = 200) and group without trigger     point (n = 200).      Outcomes: The pain intensity, function level and trigger point pain intensity outcomes will     be evaluated at the baseline, within 6 weeks for the patient to present pain in the lumbar     (acute) and after 12 weeks the pain persists (chronic)   "
12787|NCT03118050|"     The proposed research is designed to identify the mechanisms that can accelerate loss of     muscle size, strength and physical function in type 2 diabetes and with hospitalization in     older persons. About ⅓ of older Americans have type 2 diabetes, and about ⅓ of the     hospitalizations in the USA involve persons older than 65 year of age. The proposed research     is relevant to the part of NIH's mission that pertains to development of the fundamental     knowledge that will improve health and reduce the burdens of disability, because this work     will provide the fundamental evidence to identify new targets for the development of     innovative treatments to slow down muscle loss and disability in our aging society.   "
12788|NCT03118037|"     SAGE is an observational post market registry with the objective of characterizing long term     outcomes after treatment of uterine fibroids with the Sonata System in real world clinical     practice settings.   "
12789|NCT03118024|"     By comparison of two different protocols with diverse fluid/ catecholamine administration     limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure >     100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure     management on the survival rate of free deep inferior epigastric artery flaps for breast     reconstruction.   "
12790|NCT03118011|"     In the department for substance use disorders at Uppsala University Hospital there are two     wards. One that is locked, where the patients that are emitted can not go out to smoke and     another ward where there is a possibility to go out and smoke during the day.      The smoking habits on those two floors will be compared and how they feel about smoking will     be evaluated when they are admitted to the ward, at discharge, after 1 mont and after 6     months.   "
12791|NCT03117998|"     This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy,     safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1     diabetes and are currently receiving insulin treatment. This study will determine whether     REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks     of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.2 ng/mL at     Screening.      The study will be conducted at multiple sites in the United States. Approximately 75 subjects     with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into     one of three treatment groups.   "
12792|NCT03117985|"     Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4     T lymphocytes and rebounding viruses after treatment interruption   "
12793|NCT03117972|"     In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death     risk and strategy stratification are lacking. In this setting, a simple biological scoring     system have recently been proposed, including LDH and CD138 binary status seric values,     identifying one third of patients with worst prognostic.      Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and     Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E     mutation, concerning 5-8% of first line mCRC.      For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study     is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard     chemotherapy arm, in order to better discriminate treatment strategies, at metastatic     diagnosis.   "
12911|NCT03116425|"     Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to     improve symptoms of patients suffering from chronic catatonia.   "
12962|NCT03115762|"     This trial will investigate the pharmacokinetic,immunogenicity and safety biosimilarity of     ASKB1202 compared to bevacizumab sold in China and Europe.   "
24031|NCT02971111|"     The purpose of this study is to analyze occurence of bleeding complications during invasive     procedures in septic patients with normal tromboelastometry results despite prolonged     standard coagulation tests results   "
12794|NCT03117959|"     The purpose of our study is to determine if anatomic/kinematic total knee arthroplasties     (TKAs) are superior to mechanical axis-referenced TKAs with respect to determinants of gait     functionality, patient satisfaction and other objective tests of knee function as a potential     indicator of long-term prosthesis outcomes. To our knowledge there has not been any     literature comparing TKAs using the kinematic and mechanical axes with respect to gait     analysis. A single study has compared gender-specific TKAs and found that there is no     difference with respect to determinants of gait when using these prostheses (Thomsen et al,     2012), but again this study was not based on referencing off of the anatomical/kinematic axis     of the knee. Our group is hoping that the small variability that may be detectable with the     precision of gait analysis may be used as a predictor of future prosthesis outcome measures.   "
12795|NCT03117946|"     The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer     patients treated by concomitant radiochemotherapy (i-RTCT)   "
12796|NCT03117933|"     The trial will compare the drugs olaparib and cediranib with standard chemotherapy in BRCA1/2     mutated platinum resistant ovarian cancer. Patients will be randomised to one of three     treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The     aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated     including the participants quality of life.   "
12797|NCT03117920|"     MinPAC aims to see if the drug Minnelide can slow down tumour growth in patients with     pancreatic cancer that is not responding to treatment. Minnelide is designed to rapidly     release the anti-tumour molecule triptolide in the bloodstream and has been shown to slow     cancer cell growth and induce cancer cell death. Minnelide is currently being investigated in     other early phase trials and has shown promising response data.      There are strict eligibility criteria for this trial. Broadly speaking, patients with     pancreatic cancer that has spread to other organs and has progressed on one or more     chemotherapy regimens are eligible. Participants will receive Minnelide on days 1-21 of each     28 day cycle until their cancer stops responding to treatment. After that participants will     be followed up 3 monthly for the collection of disease status and survival data.      MinPAC includes biological and imaging studies. Participants will be asked to donate tumour     and blood samples and will be asked to undergo additional PET Scans. The study is being     carried out in 4 sites in the UK and USA.   "
12798|NCT03117907|"     Despite advances in medicine, secondary neonatal infection remains a continuing concern     because of the associated high morbidity and mortality. The usual mechanism of infection     responds to the transmission of germs by the equipment used for care (eg, catheters) and by     the hands of caregivers. In preterm infants in particular, some infections can also have an     endogenous source, by translocation of colonization germs present in the digestive tract.      The first line of prevention of secondary infection corresponds to compliance with the rules     of hand hygiene, work surfaces and equipment carried out, the effect of which on the control     of the incidence of secondary infection is regularly demonstrated. When declared, bacterial     infection should be treated as quickly as possible with appropriate and effective antibiotics     to preserve the healing prognosis. Compared to the infant and the larger child, clinical     signs of calling are atypical and discrete. In the absence of staff trained to monitor     newborns specifically, there is a real risk of discovering the existence of the infection     only at an advanced stage corresponding, among other things, to circulatory collapse. This     risk is not completely excluded, even with experienced practitioners, because the positive     signs are rude and may go unnoticed (eg, signs of calling such as fever are rare in the     newborn). Support for early diagnosis of neonatal infection by automatic monitoring systems     has reduced mortality by 30% in the units where it has been applied. This is probably due to     the fact that early warning made it possible to start the antibiotic treatment earlier and to     complete the bacteriological diagnosis in order to better orient the therapeutic attitude.     The best criteria for early diagnosis by automated systems were provided by the statistical     analysis of cardiac variability, the results of the research and correspond to the standard     deviation, the asymmetry and the entropy of the series d Cardiac intervals. Since microbial     aggression has an impact on many vegetative variables outside of the electrocardiogram, our     current research aims to determine whether the analysis of the perfusion index (PI) Which are     of interest for detecting disturbances in the early stages of infection in newborns. IP     corresponds to the ratio of the amplitude of the oscillating phase to the intensity of the     constant part of the opto-plethysmography wave; It is obtained from signals recorded in a     non-invasive manner by the same infrared sensor for pulse oximetry.   "
12799|NCT03117894|"     There is no consensus regarding which alternative is the best anesthesia for breast surgery,     general anesthesia and morphine for postoperative analgesia or a combination of regional     anesthesia and general anesthesia that possibly attenuates or abolishes the need for     morphine.      The current study aims to determine which of the two strategies that is best in relation to     postoperative pain, nausea and risk of recurrence of the disease.   "
12800|NCT03117881|"     The purpose of this study is to compare the effects of two delivery models of an     evidence-based complementary alternative medicine (CAM) program that combines     neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with     multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different     delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM).     Participants will be randomly assigned to one of these two groups.   "
12801|NCT03117868|"     Fractures of the upper femur (EFSF) represent a major public health problem in the elderly.     Approximately 1.6 million patients are victims each year of an EFSF and this number is     increasing as a result of the aging of the population.      In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of     the fracture. In surviving patients, the impact on loss of autonomy and degradation of     quality of life is considerable.      The reduction of the incidence of post-operative complications includes the identification of     risk factors.      No prospective study in Amiens has investigated the mortality and the study of the variables     involved in the prognosis and long-term mortality of these patients.   "
12802|NCT03117855|"     This phase I trial studies the side effects of capecitabine and Y-90 radioembolization in     treating patients with bile duct cancer in the liver that has spread to other places in the     body and cannot be removed by surgery. Radiation therapy, such as Y-90 radioembolization,     injects tiny radioactive Y-90 microspheres into the blood supply next to the liver tumors to     kill tumor cells. Capecitabine may make radiation more effective. Giving capecitabine and     Y-90 radioembolization may work better in treating patients with bile duct cancer in the     liver.   "
12912|NCT03116412|"     It is not known whether radiological assessments during follow up after surgery for high risk     melanoma improve survival. Since radiological examinations are resource demanding, could     inflict worry and cause irradiation exposure it is an important question to address. With the     introduction of effective medical treatments for malignant melanoma patients, there is a     tendency to introduce radiological assessments despite the lack of evidence.   "
12803|NCT03117842|"     In Cambodia, HIV is prevalent in several high-risk groups including among female     entertainment workers (FEWs) who work at entertainment venues such as karaoke bars and     massage parlors and may engage in direct or indirect sex work. Reaching FEWs with sexual and     reproductive health services such as testing and treatment for HIV and sexually transmitted     infections (STIs) and contraception has been difficult because they are hidden and     stigmatized. Mobile phone-based interventions may prove to be an effective way to reach this     population and connect them with the existing services. This article describes study design     and implementation of a two-arm randomized controlled trial of a mobile health intervention     (the Mobile Link) aiming to improve sexual and reproductive health outcomes among FEWs in     Cambodia. A two-armed randomized controlled trial (RCT) will be used to determine the     effectiveness of a mobile phone-based text/voice messaging intervention. The intervention     will be developed through a participatory process; 50 FEWs will work alongside researchers in     focus groups to modify and tailor behavior change theory-based text and voice messages. Then,     600 FEWs will be recruited and randomly assigned into one of two arms: (1) a control group     and (2) a mobile phone message group (either text messages or voice messages, delivery method     chosen by participant). The primary outcome measures include HIV testing, condom use, STI     testing and treatment and contraceptive use. If the Mobile Link trial is successful, an     increase in condom use, screening and treatment for HIV and STI and contraception use is     expected. These outcomes would lead to a reduction in the prevalence of HIV, STIs and     unintended pregnancies. This trial is unique in a number of ways. First, the option of     participation mode is offered to allow participants to choose the message medium that best     links them to services. Second, this is the first RCT of a mobile phone-based behavior change     intervention using SMS/VMs to support linkage to sexual and reproductive health services in     Cambodia. Third, we are working with is a hidden, hard-to-reach and dynamic population with     which traditional methods of outreach have not been fully successful.   "
12804|NCT03117829|"     Brief Summary:      Project Summary Metabolic syndrome (MetS) is associated with the development of diabetes and     cardiovascular disease; however it is also linked with cognitive decline and dementia. The     study investigators have shown that MetS is associated with lower cerebral blood flow (CBF)     and memory function in late middle-aged adults at increased risk for developing Alzheimer's     disease (AD). Insulin resistance (IR) is at the core of MetS, and a hallmark feature of IR is     higher fasting blood glucose (FBG) as well as post prandial hyperglycemia.      While the study investigators and others have demonstrated links between IR and CBF as well     as cognition from an observational perspective, no studies have investigated CBF and     cognition after an intervention involving exercise and a carbohydrate restricted diet (CRD)     designed to improve or normalize IR and glucose homeostasis. The study investigators propose     to determine the effect of improving or normalizing glucose homeostasis on CBF and cognition,     through diet and exercise, in individuals with IR and at risk for the development of AD.      While exercise and a CRD have been shown to improve IR and glycemic control, we have only     limited knowledge of the mechanisms behind these improvements. Nutritional metabolomics, the     global measurement and interpretation of metabolic profiles, assesses the interaction of diet     with the endogenous gene-protein cascade and the gut microbiome. Additionally, exercise has     been shown to have an impact on the human metabolome. Finally, numerous metabolites have been     specifically linked to IR and impaired fasting glucose (IFG). The study investigators propose     to use metabolomics to measure changes in metabolites as individuals normalize or improve IR     and glucose homeostasis.      Should this exploratory study reveal increased brain blood flow and improved memory in     response to diet and exercise, then early treatment of these individuals at risk might offer     new avenues for disease-course modification. Strategies towards early and effective risk     factor management could be of value in reducing the risk of metabolic as well as cognitive     decline. In addition, should this study reveal changes in metabolic abnormalities consistent     with early indications of diabetes, metabolomics could be an effective approach to complement     disease risk analysis in our goal toward precision care.   "
12805|NCT03117816|"     A randomized, open-label assessor blinded, multi-center, controlled phase II Trial to     evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing     molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase     inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).   "
12806|NCT03117803|"     This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In     addition, the investigators will analyze the risk factors for the rupture of the UIA and     their joint effect. The investigators aim to use research data to create a China national     database of UIA.   "
12807|NCT03117790|"     Sleep disturbances frequently occur in elderly patients after major surgery; and their     occurrence are associated with worse outcomes including increased incidence of delirium.     Previous studies showed that, for elderly patients admitted to the ICU after non-cardiac     surgery, low-dose dexmedetomidine infusion improved to some degree the quality of sleep and     reduced the incidence of delirium. The investigators hypothesize that, for elderly patients     after major non-cardiac surgery, dexmedetomidine supplemented analgesia can also improve the     sleep quality. The purpose of this randomized controlled pilot study is to investigate the     impact of dexmedetomidine supplemented analgesia on the sleep quality in elderly patients     after major non-cardiac surgery.   "
12808|NCT03117777|"     This is a quality assurance project to evaluate a therapy program offered to patients in     Sleep Disorders Clinic. Group Cognitive Behavioral Therapy for Insomnia (CBT-I) is being     offered to older adults. The study will consist of analyzing outcomes of a clinical program.     As part of standard clinical process, patients complete measurements of sleep, daytime     functioning, fatigue, quality of life, depression and anxiety symptoms before and after the     treatment. The proposed study will pool and quantitatively analyze the existing clinical     data. Only those program participants who consent to have their data pooled in the data     analysis will be considered research subjects. Those patients who decline to have their     individual data included in the analysis will continue in the therapeutic group as per usual     clinical care standards.      CBT-I is a gold standard treatment for people suffering from insomnia but it is difficult to     access due to a shortage of trained therapists. Insomnia prevalence increases with age and is     a common sleep disturbance in the elderly. Offering the group treatment can increase access     and reduce healthcare costs associated with sleep problems in the elderly.   "
12809|NCT03117764|"     The investigators know that peripheral muscle weakness and exercise intolerance are prevalent     (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an     important underlying factor. Those conditions are associated with a poor prognosis (Nixon et     al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical     activity remains unclear.      The aim of the study is to evaluate the impact of intravenous antibiotherapy on peripheral     muscular strength in patients with cystic fibrosis (adults and children) who receive     intravenous antibiotherapy for an acute exacerbation or electively (decline in lung function     without exacerbation).   "
12810|NCT03117751|"     The overarching objective of this study is to use novel precision medicine strategies based     on inherited and leukemia-specific genomic features and targeted treatment approaches to     improve the cure rate and quality of life of children with acute lymphoblastic leukemia (ALL)     and acute lymphoblastic lymphoma (LLy).      Primary Therapeutic Objectives:        -  To improve the event-free survival of provisional standard- or high-risk patients with          genetically or immunologically targetable lesions or minimal residual disease (MRD) ≥ 5%          at Day 15 or ≥1% at the end of Remission Induction, by the addition of molecular and          immunotherapeutic approaches including tyrosine kinase inhibitors or blinatumomab for          refractory B-ALL, and the proteasome inhibitor bortezomib for those lacking targetable          lesions.        -  To improve overall treatment outcome of T-ALL by optimizing pegaspargase and          cyclophosphamide treatment and by the addition of new agents in patients with targetable          genomic abnormalities (e.g., activated tyrosine kinases or JAK/STAT mutations) or by the          addition of bortezomib for those who have a poor early response to treatment but no          targetable lesions.        -  To examine in a randomized study design whether the administration of one dose of          rituximab to children with B-ALL during early Remission Induction therapy decreases          allergic reactions to pegaspargase.        -  To determine in a randomized study design whether the incidence and/or severity of acute          vincristine-induced peripheral neuropathy can be reduced by decreasing the dosage of          vincristine in patients with the high-risk CEP72 TT genotype or by shortening the          duration of vincristine therapy in patients with the CEP72 CC or CT genotype.      Secondary Therapeutic Objectives:        -  To estimate the event-free survival and overall survival of children with ALL and LLy.        -  To examine whether the administration of one dose of rituximab can lower the minimal          residual disease (MRD) levels.        -  To determine the tolerability of combination therapy with ruxolitinib.      Biological Objectives:        -  To use data from clinical genomic sequencing and sequencing-based MRD in bone marrow,          blood and cerebrospinal fluid.        -  To assess clonal diversity and evolution of pre-leukemic and leukemic populations.        -  To identify germline or somatic genomic variants associated with drug resistance of ALL          cells.        -  To compare drug sensitivity of ALL cells from diagnosis to relapse.      Supportive Care Objectives        -  To conduct serial neurocognitive monitoring of patients and to evaluate the benefits of          a computer-based cognitive intervention.        -  To evaluate the impact of low-magnitude high frequency mechanical stimulation on bone          mineral density and markers of bone turnover.      Exploratory Objectives:        -  To identify pharmacogenetic, pharmacokinetic and pharmacodynamic predictors of treatment          outcome.        -  To perform a detailed assessment of thiopurine metabolism and 6-mercaptopurine (6MP)          tolerance, toxicity, and treatment outcome.        -  To establish xenografts of representative subtypes of ALL.        -  To prospectively determine the risk and epidemiology of breakthrough infection or          febrile neutropenia and adverse effects of antibiotics.   "
12811|NCT03117738|"     This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in     subjects with Alzheimer's Disease. Following first screening period, subjects will be     randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1     ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure     will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up     visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.   "
12812|NCT03117725|"     Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn     may decrease the reproductive function. Many researchers have already proven improvement on     reproductive function after antioxidant (melatonin) administration. The investigators wish to     study the relationship between unexplained, young poor ovarian responder and oxidative     stress.   "
12814|NCT03117699|"     This is a study for a new mechanical transport device adapted to the hemiplegic patients.      Healthy volunteers :      After explaining the protocol and presenting the movement laboratory, the subjects are     equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are     installed on a seat positioned in front of 2 force platforms installed on the ground. The     seat is equipped with a force platform.      Phase 1 :      After being seated, the subject realizes :        -  3 seat to stand and stand to seat without assistance        -  3 seat to stand and stand to seat using a handle located in front of it (handle equipped          with a 6-axis force sensor)        -  3 seat to stand and stand to seat using the experimental device This phase will last          45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing)      Phase 2:      After being seated, the subject performs a course comprising:        -  A standing pass from sitting on a chair        -  A straight line movement        -  A succession of left and right turns        -  An upward and downward travel of less than 1%.        -  Standard doorway        -  Standing on the toilet        -  A sitting pass from the toilet        -  One way to a bed        -  A sitting pass on the bed        -  A passenger seat sitting upright from the bed        -  A return to the starting point        -  A sitting pass on the starting chair Each stage is timed. A subjective analysis of each          step is done by a lickert scale on the perceived comfort and safety.      This phase 2 will last 30mn (15mn of course and 15mn of questions).      Hemiplegic subjects :      At each session, the subject is examined by a physician who evaluates the motor control (Fugl     Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale).      Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which     are impossible.      Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each     subject in therapeutic apartment in simulated living conditions. The validation in living lab     is carried out by an ergonomist and by a questionnaire on the comfort and safety of the     various steps identified by the ergonomist.   "
12815|NCT03117686|"     High altitude pulmonary edema is a life-threatening condition that remains a concern for     climbers and clinicians alike. It is defined as a non-cardiac pulmonary edema occurring at     altitudes exceeding 3000m in non-acclimatised individuals. Recently, studies conducted in     remote areas have demonstrated that ultrasound lung comets (B lines) can be used as a measure     of sub-acute pulmonary edema and high altitude pulmonary edema in climbers ascending to     altitude. the investigators want to assess the occurrence of of comet tails (B lines) as a     measure of pulmonary edema among patients after lung transplantation and healthy individuals     during an expedition to Mount Kilimanjaro.   "
12816|NCT03117673|"     Transesophageal echocardiography (TEE) plays an important role in intraoperative monitoring     and can be used to estimate pulmonary artery pressures. An excellent correlation between     right ventricular systolic pressure (RVSP) measured by right heart catheterization (RHC) and     simultaneously estimated by transthoracic echocardiography is reported and also implemented     into the current guidelines for the echocardiographic assessment of the right heart in adults     by the American Society of Echocardiography. So far there are no studies evaluating RVSP     measured by transesophageal echocardiography (TEE) and recommendations are unclear which     transesophageal view is the best for calculation.      We want to assess if there is a difference in the systolic pulmonary artery pressure measured     invasively with a pulmonary artery catheter (PAC) and the calculated right ventricular     systolic pressure (RVSP) using transesophageal echocardiography (TEE) in 3 different views:     ME 4Ch, ME RV inflow-outflow, ME modified bicaval.   "
12817|NCT03117660|"     Prospective drug interaction study during pregnancy.   "
12818|NCT03117647|"     Postpartum hemorrhage is the leading cause of maternal, uterine atony accounts for 75-90% of     primary postpartum hemorrhage. The efficacy of the Uterine compression suture in the     treatment of atonic postpartum hemorrhage is time-tested and can be said to be almost     established .The aim of this study was to assess the role of the Mansoura-VV uterine     compression suture as an early intervention in the management of primary atonic postpartum     hemorrhage.   "
12819|NCT03117634|"     Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula     degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic     differences, PCV is thought to have a lesser response to anti VEGF therapy which is the     mainstay of treatment for other typical wet AMD. Recent trial data suggest that a combination     with photodynamic therapy may help in the visual and anatomical outcome of PCV, and emerging     evidence shows favourable outcomes the newer anti VEGF agent, aflibercept 2mg monotherapy.     These trials however, have assessed aflibercept in a strict 2mg every 8 weekly regime.      In the clinical setting, a significant an unmet need in the management of PCV is a tailored     treatment regime. Here we propose a treatment regimen based on disease activity for PCV with     aflibercept mono therapy. A limitation of the 2q8 regime is that it is fixed and does not     vary regardless of polyp closure or anatomical outcome at the first time point of assessment     (month 3). We hypothesize that after the initial 3 monthly injections of aflibercept, about     50% of PCV will close and become quiescent, and in the remaining 50%, a further 3 monthly     injections will increase overall polyp closure rate. After a loadings phase of either 3 or 6     months, all eyes will start on a treat and extend regime (T&E), with a minimum period of 8     weeks and a maximum of 12 weeks between treatments with 2 week increments if PCV remains     quiescent. The proposed study aims to evaluate the efficacy of a modified treat and extend     regime based on disease activity with aflibercept monotherapy for PCV.   "
12820|NCT03117621|"     An observational study of blinatumomab safety and effectiveness, utilisation, and treatment     practices   "
12821|NCT03117608|"     The study proposes to compare performances and safety of intra-articular injections of aMAT     with those of a control group (PRP injections) for the treatment of symptomatic OA of the     knee. The end-points will be determined evaluating the performances of the treatment group in     terms of improvement of the symptomatology, functional recovery and radiological appearance.   "
12823|NCT03117582|"     Purpose: To study the changes in the microbiome and stool composition in patients with     Clostridium Difficile Infection (CDI) who undergo Fecal Microbiota Transplantation (FMT),     along with changes in their clinical characteristics.   "
12825|NCT03117556|"     This study aims to compare the efficacy of bilateral thoracoscopic splanchnicectomy (BTS) to     conventional narcotic analgesia for control of abdominal pain in patients with pancreatic     ductal adenocarcinoma not amenable to surgical resection.   "
12845|NCT03117296|"     Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of     services on Post procedure day #1 and continued daily with focus on education and activity     progression) for all patients undergoing a transcatheter aortic value repair procedure began     on December 2, 2014. Retrospective data was collected from The Society of Thoracic     Surgeons/American College of Cardiology Transcatheter Aortic Valve Replacement Procedures     (STS/ACC TVT, trademark) Registry - National database for Transcatherter Aortic Valve     Replacement Procedures and included subjects from March 2012 through July 31, 2015. Patients     included: s/p tAVR via transfemoral catheter approach, with or without minor intra or post     procedure events (GI bleeds, minor access bleeds, afib, etc); Exclusions: Major events     including stroke, pacemaker placement, other cardiovascular (CV) repair or surgery required,     etc). Future data analysis will extend subjects to December 31, 2015 and annually.   "
12826|NCT03117543|"     Gestational diabetes (GDM) means raised blood glucose found for the first time in pregnancy.     GDM is common, particularly in women from minority ethnicities. GDM does not cause any     symptoms in the mother. GDM is associated with adverse pregnancy outcomes which can be     improved with treatment of GDM. The United Kingdom National Institute for Health and Care     Excellence (NICE) recommend pregnant women with one or more risk factors should have a 75g     oral glucose tolerance test (OGTT). The OGTT is performed in a clinic with venous plasma     glucose measured fasting and at 2 hours. This is resource-intensive, and some women with GDM     may be missed by this risk-factor based approach. The International Association of Diabetes     and Pregnancy Study Groups (IADPSG 2010) recommends screening all pregnant women with 2-hour,     3 sample (fasting, 1 and 2 hour), 75g OGTT, which is even more resource intensive. Developing     more cost-effective and convenient approaches to screening for GDM is a priority.      The researchers will validate a new home-use OGTT system (hOGTT), which measures whole blood     glucose in capillary blood ('finger-stick' sample), against the gold standard venous plasma     glucose in pregnancy.      The researchers will also investigate the performance of glycated haemoglobin (HbA1c) in     screening for GDM. HbA1c is used for diagnosis of diabetes outside of pregnancy, but is     currently not recommended for screening for GDM.      The researchers will also investigate relationships between glucose measured in different     samples (venous versus capillary), different fractions (plasma versus whole blood), and using     different methods in pregnancy.      In a substudy the researchers will investigate: ethnic differences in HbA1c and other     glycaemic markers; the contribution of fasting and postprandial glucose handling, diet and     ethnicity on HbA1c; and ethnic differences in insulin responses to 75g OGTT in pregnancy.      The researchers will invite pregnant women between 16-34 weeks gestation to participate. The     research involves one hospital visit for an OGTT. Participants will have venous blood samples     taken fasting and at 1-hour and 2-hours, and at the same times finger-stick blood samples     will be tested. The researchers will invite women of Black African, Black Caribbean and White     European ethnicity to participate in a substudy in which participants will have extra blood     taken and a diet assessment.      If the hOGTT provides accurate results in pregnancy, using it to perform OGTTs at home would     make screening for GDM less expensive and more convenient and may facilitate universal     screening for GDM. Understanding ethnic differences in HbA1c will help determine if HbA1c is     a reliable screening tool for GDM in our ethnically diverse local population.   "
12827|NCT03117530|"     Autism spectrum disorders (ASD) are highly disabling, persistent neurodevelopmental     disorders. There are no available treatments for core symptoms of ASD or biologically-based     clinical biomarkers. Emerging evidence indicates that levels of brain inflammation are     increased in ASD. In particular, recent work implicates hyperactivity of microglial cells,     the resident immune cells of the brain. However, the functional consequences of microglial     activation remain unknown. This study will measure microglial activation in ASD using     positron emission tomography (PET) brain imaging. Adult males with ASD (n=15) and healthy     controls (n=15) will be recruited for this study and undergo comprehensive clinical and     behavioral baseline assessment. All subjects will then undergo baseline PET imaging using a     radiotracer that labels activated microglia. Subjects with ASD will then undergo 12-week open     label treatment with minocycline, an FDA-approved antibiotic thought to block microglial     activation. PET imaging will be repeated at 12 weeks to confirm target engagement. A subset     of control subjects will also undergo repeat PET imaging to determine test-retest     reliability. During minocycline treatment, ASD subjects will be evaluated every 2 weeks for     safety, clinical impression, behavioral functioning, and measures of cognition. Results will     provide important information regarding the relationship between levels of brain     inflammation, cognitive and behavioral function in ASD.   "
12828|NCT03117517|"     Objective:        1. To investigate the changes in the levels of interleukin-6 and interleukin-8 after 3          months treatment with metformin alone and combination of metformin and pioglitazone in          patients with polycystic ovarian syndrome (PCOS).        2. To evaluate insulin resistance in all the groups at baseline and after 3 months of          treatment.      Design: Two-Arm Randomized Clinical trial.      Setting: Out-Patient Department (OPD) of Mardan Medical Complex, Khyber Medical University.      Patient(s): One hundred and two patients with PCOS.      Intervention(s): 51 women will receive metformin according to the body weight with maximum     dose of 1000 mg (BD) daily. Remaining 51 will receive metformin and pioglitazone combination     according to the body weight with maximum dose of 1000 mg and 30 mg (BD) daily.      Main outcomes measure(s): Serum concentrations of fasting blood glucose, insulin, homeostatic     model assessment for insulin resistance (HOMA-IR), follicle stimulating hormone (FSH),     luteinizing hormone (LH), interleukin-6 (IL-6) and i-nterleukin-8 (IL-8).   "
12829|NCT03117504|"     Stress urinary incontinence is the most common type of incontinence during pregnancy.our     study aims at determining the prevalence in the first and third trimesters and the associated     risk factors.   "
12830|NCT03117491|"     Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates     nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods:     One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected.     subjects randomly received two IANB injections or two GGNB injections or their combination of     1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on     the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation     or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.   "
12831|NCT03117478|"     The main aim of this project is to explore the neuro-anatomical and -physiological correlates     of meditation on attention and emotion-regulation. By investigating this, our scientific goal     is to more generally identify the mechanisms and biomarkers of health and mental well-being.     Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG),     ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI;     including Diffusion tensor - DTI). These brain measures will then be linked to behavioral     measurements. Experimental methods (i.e., simple computer tasks) will be used to measure     attention, conscious perception and regulation of pain and emotion.   "
12832|NCT03117465|"     To apply Bold-fMRI technology to observe and compare the differences of task-related     activation of relevant brain cortex region in stroke hemiplegic patients and healthy subjects     after finger grasping movement.   "
12846|NCT03117283|"     Bursectomy is widely performed in open surgery for advanced gastric cancer in East Asia.     However laparoscopic D2 radical total gastrectomy with complete bursectomy is difficult and     rare performed. Herein, we conduct a single-centre randomized controlled trial to explore the     safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left     outside bursa omentalis approach for achieving complete bursectomy.   "
12847|NCT03117270|"     This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with     active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized     to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo     q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum     of 20 weeks (from Screening visit to Follow-up visit).   "
13367|NCT03110575|"     This is an open-label, extension trial designed to evaluate safety over 12 additional weeks     of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited     into this trial are those who have successfully completed the double-blind lead-in study.   "
12833|NCT03117452|"     Schizophrenia is a severe psychiatric condition that is associated with significant distress     and disability. In addition to cognitive difficulties in domains such as attention, memory,     and problem-solving, individuals with schizophrenia can experience visual-processing     abnormalities, including impairments in visual acuity, low-contrast stimulus detection, and     perceptual organization (i.e., perceiving visual information in an organized perceptual     whole). These visual impairments are clinically significant, with research indicating that     specific visual-processing alterations are significantly related to poorer performance on     higher-level cognitive tasks, impaired facial emotion recognition, impaired reading ability,     and worse functional outcomes. Despite such findings, very few studies have evaluated the     therapeutic potential of interventions that are specifically designed to improve visual     processing (visual remediation) for individuals with schizophrenia. Thus the aim of this     study is to evaluate the efficacy of a computerized visual perceptual training program that     targets low- and mid-level visual processes to improve visual, cognitive, and     emotion-recognition functions in outpatients with schizophrenia through a small randomized     controlled trial. The investigators will recruit up to 40 individuals with schizophrenia or     schizoaffective disorder who are receiving treatment in Rutgers University Behavioral Health     Care (UBHC) Partial Hospital Program; half will be randomized to receive the computerized     visual training, which will be delivered in small groups over a period of 12-14 weeks. The     specific aims of this study are to collect preliminary data on: 1) the feasibility of     participant recruitment and retention, and tolerability of the treatment components of the     study; and 2) the efficacy of computerized visual training (VT) to improve low- and mid-level     visual processes, and higher-level cognitive and social-cognitive performance. Based on     preliminary data, the investigators hypothesize that the target number of participants will     be successfully recruited and engaged in the VT intervention (n=16) and control condition     (n=16), and that the participants who receive VT will demonstrate greater improvements on     measures of low- and mid-level visual, higher-level cognitive, and social-cognitive functions     compared to those who receive standard partial-hospital care without VT. The results of this     initial trial will be used to inform the design and application for funding of a larger-scale     investigation of visual remediation for individuals with schizophrenia.   "
12834|NCT03117439|"     This study is aimed to compare the duration of standard anti fungal therapy in high risk ICU     patients with a strategy driven by BetaDGlucan test result   "
12835|NCT03117426|"     Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the     postoperative accommodative loss of the human eye has been a trending topic. Numerous studies     show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs     (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are     common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony     Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter     referred to as Symfony IOL) is theoretically providing a continuous range of high-quality     vision for far, intermediate, and near distances with the same low incidence of halos and     glare associated with monofocal IOLs under different light conditions.      The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena,     Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of     postoperative achieved visual acuity at different distances, patient satisfaction (e.g.     spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare)     under different light conditions. So far, there are no published studies comparing both IOLs.     Therefore, we will perform this randomized control trial.   "
12836|NCT03117413|"     Our main objective is to study how the extent of reorganization of the central auditory     system is related to the binaural integration in cochlear implanted subjects with asymmetric     hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a     control group of normal hearing subjects will perform two tests for binaural integration     (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds     perception.   "
12837|NCT03117400|"     To date there are no available data on the utility of the endoscopic mucosal resection (EMR)     defect in stratifying the risk of immediate or delayed adverse outcomes, particularly     clinically significant post EMR bleeding (CSPEB).      The investigators aimed to analyse the data to determine if any of these EMR defect features     allow us to estimate the risk of CSPEB. This will help endoscopists to identify defects with     a high risk of adverse outcomes and may translate into improved patient outcomes.   "
12838|NCT03117387|"     Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block     during anesthesia. However AMG is known to be inaccurate when compared to the gold standard     in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the     patients arms require to be positioned next to the body and beneath surgical drapes, AMG     measurements are often hindered and inaccurate. The TOF cuff is a new device which measures     NMB at the upper arm with a blood pressure cuff. It overcomes the previously mentioned     disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been     investigated.      This study aims to compare the bias, limits of agreement and precision of the TOF cuff     relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients     with normal body mass index and morbidly obese patients.   "
12839|NCT03117374|"     The goal of this study is to evaluate the impact of an innovative web-based school nutrition     intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit     and dairy products in high school students and to identify facilitators and/or barriers     influencing its success.   "
12840|NCT03117361|"     This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to     evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in     patients with Multiple Myeloma (MM) double refractory to bortezomib and lenalidomide.   "
12841|NCT03117348|"     Patients will be randomized to Gradual or immediate Goal-dose EN group at day 3 after     abdominal surgery. Patients will receive Goal-dose EN gradually or immediately after     abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy     delivered by oral feeding or patients are discharged from hospital. The primary and secondary     outcomes will be collected.   "
12842|NCT03117335|"     The main object of this trial is to offer treatment of recombinant endostatin ( Sulijia)     combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for     advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) ,     disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared     with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.   "
12843|NCT03117322|"     Randomized double blind controlled clinical trial. Participants will be enrolled at the New     Civil Hospital of Guadalajara Dr. Juan I. Menchaca during the period from May 2017 to July     2018, from six to 59 months of either sex. The duration of each participant in the study will     be of four weeks. Each participant will be randomized assigned to any of the different study     groups: synbiotic, prebiotic, probiotic or placebo. Hypothesis: The efficacy of     supplementation with a symbiotic, a prebiotic and a probiotic differs in its beneficial     effect on the intestinal microbiota and the characteristics of feces in children with CP and     chronic constipation.   "
12844|NCT03117309|"     Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.   "
12848|NCT03117257|"     This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin     induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction     chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced     head and neck squamous cell carcinoma.   "
12849|NCT03117244|"     The human foot allows to perform several functions, rather than providing a Static support     for the body, the foot acts dynamically in walking and Movement of the body, requiring     adequate biomechanics responsible for Maintenance and posture of the body and harmonic     distribution of plantar pressure.      One of the most important structures for this control is the medial plantar vault (MPA), an     important structure in the absorption of impact and essential for the function Foot. The     deformation of the MPA in the gait support phase absorbs the Energy and propels the limb, to     perform this biomechanical function the MPA must Stable from the anatomical point of view,     which is conferred by the bone architecture and But also by the performance of the intrinsic     and extrinsic musculature of the Feet. The fall of the MPA, decreases the stability of the     foot, limits its biomechanical function,      Besides being a risk factor for the development of pathologies such as:      Tendinopathy of the calcaneus tendon and plantar fasciitis. Various Intrinsic Muscles And     extrinsic have the function of stabilizing the foot and the MPA, being the main Extrinsic     muscles: the posterior tibial, the flexor long of the hallux and the fingers. The Muscles     when activated increase the height and decrease the Length of the MPA. Several methods are     used to evaluate ALM, such as (AN), Feiss line (LF) and MPA angle (MPAH), in addition to the     Baropodometry, which is used to evaluate dysfunctions in the feet, with the principle of Map     the pressure of the plantar surface in a static and dynamic way. Based In this information,     this study aims to evaluate the influence of the Strengthening of the intrinsic and extrinsic     muscles of the feet, for the Of MPA in asymptomatic patients.   "
12850|NCT03117231|"     The purpose of this study is to investigate the effects of transcranial direct current     stimulation (tDCS) in elderly with pain due to knee osteoarthritis. The researchers suppose     that there will be a decrease in pain levels with active stimulation, when compared to sham     stimulation.   "
12851|NCT03117218|"     This study aims to evaluate whether quantitative analysis of coronary MR angiogram would     improve the detection of functionally-significant coronary artery stenosis.   "
12852|NCT03117205|"     Background: Recently, several professionals are using the Kinesio Taping® in the treatment of     pathologies related to the knee, aiming to improve the motor control, increase the response     of muscle activation and promoting better joint stability.      Purpose: The objective of this study is to evaluate the effect of the application of Kinesio     Taping® in motor control of patients with patellofemoral pain syndrome.      Methods: This is a 2-arm, randomized with a blinded assessor. We selected 40 women with     patellofemoral pain (age 25.2±4,years) were randomly assigned to one of two groups: placebo     group (n= 20) and the Kinesio Taping® group (n=20). The placebo group received the     application of a non-stretchable tape (Micropore) crosswise on the thigh and the Kinesio     Taping® group followed all the criteria of the method in placing the bandage. All patients     received the evaluation of the motor control banding pre and post a patch, by means of the     method Y balance test.   "
12853|NCT03117192|"     Randomized controlled trial was conducted in post-splenectomy patients aged >12 years.     Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50     mg/day) of Zinc is administered.   "
12854|NCT03117179|"     Each year more than 15 million French people visit the emergency services and almost 80% of     them come out without hospitalization after having undergone a clinical examination and     possibly additional examinations.      Following their discharge, compliance with discharge requirements and recommendations     (treatment, monitoring, follow-up, etc.) is a determining factor in improving their health.     Non-membership is linked to an increase in morbidity, mortality and use of the health system.     Patient adherence to discharge instructions is conditional on patient understanding.     Unfortunately, the environment of an emergency service often creates conditions for     information and education of the patient that are often far from optimal or at least that are     specific to a typical consultation.      Data from the international literature showed that 78% of people who come out of emergency     after consultation do not clearly understand the instructions and only 20% are aware of their     lack of understanding. Waisman et al. Documented that 25% of patients did not understand     their diagnosis and that 13% to 18% did not understand treatment instructions. Heng et al.     Have shown that patients leaving after head trauma are unable to cite the symptoms that     should prompt them to consult quickly.      The involvement of healthcare teams to inform patients with the help of different     communication media is therefore particularly important in trying to improve understanding     and adherence to exit instructions. However, Zavala et al. Point to the fact that this is not     necessarily sufficient.      Some authors have identified factors of poor adherence: multiple chronic diseases, multiple     drug treatments, psychiatric disorders, but also age, social isolation, depression, quality     of life and socio-economic and cultural level , A low level of health literacy, or planned     medical follow-up, the severity of the pathology and the perception of that severity by the     patient, or the patient's dissatisfaction with medical instructions.      The patients' adherence to the literature is evaluated in a varied manner according to the     pathologies concerned: counting the number of tablets; Patient self-tracking log; Reports     from physicians, reports by third parties (such as the patient's spouse); Electronic     measurements (for example, metered-dose inhalers or electronic drop dispensers); Blood or     urine dosage. The different methods used have advantages and disadvantages that need to be     assessed according to the needs of the study we wish to implement. While declarative     investigations in the assessment of patient adherence are criticized, no method has     unfortunately been used as a benchmark for assessing adherence. The bibliographic search did     not find any questionnaires that had been validated in this context. In order to evaluate the     adhesion, the investigator will therefore opt for a semi-directed interview at D7 in order to     better control a possible bias of memorization. This tool has known limitations including a     tendency to overestimate adhesion, because patients tend to respond to what doctors want to     hear. This will be taken into account in the interpretation of the results.   "
12855|NCT03117166|"     The use of lidocaine, as an anesthetic drug, during implantation of an implantable     cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the     defibrillation threshold during ICD placement.   "
12856|NCT03117153|"     The aim of the present clinical study is to evaluate the efficacy and safety of the novel     toothpaste in patients diagnosed with gingivitis and/or periodontitis.   "
12857|NCT03117140|"     This is a prospective randomized controlled triple-masked study looking at the duration of     nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and     clonidine) plus ropivacaine versus plain ropivacaine alone.   "
12858|NCT03117127|"     In crossover trials, ten (N=10) young men (18-35 y) will receive stable isotope tracer     infusions and perform a single bout of resistance exercise. Immediately after resistance     exercise, participants will ingest stable isotope labeled whole eggs (18 g protein, 17 g fat)     or egg whites (18 g protein, 0 g fat) cooked in scrambled form. Repeated blood and muscle     biopsies will be collected to determine whole body amino acid kinetics, muscle amino acid     transporters, anabolic signaling and myofibrillar protein synthesis rates during the trials.   "
12859|NCT03117114|"     Adenomas are premalignant polyps of the colon that should be resected endoscopically.     Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases     polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be     conducted using the so-called piece meal technique in these cases. However, leaving polyp     residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer     may arise form adenomatous remnants. In case of difficult polyp locations endoscopic     resection may also be time consuming. On the other hand endoscopists are facing an increased     time pressure due to rising numbers of procedures during the last decades.      The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard     endoscope. The EVD has small flexible branches on its outside. The branches turn out during     withdrawal. By that the branches are getting in contact with colonic wall. This mechanism     leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that     resection circumstances may be improved by using an EVD. In addition, stabilizing the scope     during resection may result in a reduced time effort. Until now no controlled trials exist     investigating the effect of EVD on the time effect during polyp resection. Therefore a     randomized controlled trial needed comparing standard polypectomy versus polypectomy using     the EVD during routine colonoscopy procedures.   "
12860|NCT03117101|"     This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I     study   "
12875|NCT03116906|"     The primary objective of this trial is to investigate the safety and tolerability of BI     685509 in healthy male subjects following oral administration of multiple rising doses.      Secondary objectives are the exploration of the pharmacokinetics (PK), dose proportionality     as well as investigation of linearity and pharmacodynamics (PD) of BI 685509 after multiple     dosing.   "
12861|NCT03117088|"     Study Title Safe- SCOPE Pilot Study Standardized Checklist of Patient Information Exchange      Short Title Safe- SCOPE Pilot Study      Study Design: Single centre two armed cluster randomised crossover pilot study      Study duration: 5 months      Objectives:        -  Influence of standardised checklists on medical/ physician handovers on an Intensive          Care Unit -ICU and its influence on patient safety        -  Satisfaction survey in physicians group      Number of patients:      All patients treated on OIM during assessment period      Checklist Intervention        -  All physicians working in the department of Intensive Care Medicine and Intermediate          Care are informed and enlightened about Safe-SCOPE Pilot Study. After written consent          participating physicians will use an online form ISBAR3 Checklist or alternative          Checklist for handovers twice a day.        -  Handover times/schedule:      OIM 1,2,3,5, und 6: 7:30 am and 7:30 pm OIM 4 und WEA 1: 7:30 am and 2:00 pm        -  ISBAR3 Checklist        -  VICUR Checklist wash- out Phase:        -  No checklists for one month      Efficacy:      Patients:        -  Mortality rate        -  Duration on ICU        -  Reuptake on ICU        -  SOFA Score on admission to ICU, 48h, 72h and 120h after admission        -  Handover duration per patient        -  Number of enclosed patients      Handover:        -  Entire handover duration        -  Interruptions during handover   "
12862|NCT03117075|"     To compare the pain scales between clinician evaluated and reported with wearable device by     patients.   "
12863|NCT03117062|"     The purpose of this randomized clinical study was to evaluate the impact of occlusal     reduction on the incidences of post-instrumentation and post-obturation pain. Forty four     patients were included in this study. Inclusion criteria were posterior mandibular teeth     having symptomatic irreversible pulpitis and symptomatic apical periodontitis. Patients were     randomized into two equal groups. In the intervention group the functional and nonfunctional     cusps were reduced until absence of contact was confirmed, while in the control group the     occlusal surfaces were left intact. Standard endodontic treatment was performed in two visits     using rotary nickel titanium files for shaping, 2.5% sodium hypochlorite for cleaning and     lateral condensation technique with resin sealer for obturation. Pain was assessed     preoperatively, then after 6, 12, 24 and 48 hours following instrumentation, then after 6 and     12 hours following obturation. Visual Analogue Scale (VAS) was used as the primary outcome     measure. Patients were given a placebo to be administrated in case of severe pain and     ibuprofen 400mg was prescribed in case of persistent pain.   "
12864|NCT03117049|"     The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with     carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with     carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with     stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical     radiation in a multicenter, randomized, double-blind study.   "
12865|NCT03117036|"     This prospective study enrolls patients who are diagnosed with aggressive lymphoma including     Hodgkin and non-Hodgkin lymphomas. Enrolled patients will be treated according to our     institution' treatment policy in clinical practice. The disease status including response to     therapy and survival status will be regularly updated during the study period. Patients'     serum and cell-free DNA will be collected and analyzed.   "
12866|NCT03117023|"     The purpose of this study is to find out the effect of Dexmedetomidine for treatment of sleep     deprivation, pain relief and postoperative recovery on middle-aged and elderly Patients with     Gastric Cancer.   "
12867|NCT03117010|"     This prospective study enrolls subjects who have clinical and laboratory manifestations     related with hemophagocytic lymphohistiocytosis. The purpose of the study is to evaluate     clinical and biological features of adult hemophagocytic lymphohistiocytosis. The enrolled     subjects into this study will be evaluated according to the HLH (hemophagocytic     lymphohistiocytosis)criteria and treated with systemic immunosuppressive therapy or     chemotherapy. All subjects will be regularly monitored by physicians participating in this     study.   "
12868|NCT03116997|"     The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate     and sugammadex) to see if one drug improves patient comfort regarding the return of muscle     strength after surgery.   "
12869|NCT03116984|"     This clinical trial is a prospective, randomized, controlled and multicenter study.And the     trial is going to enroll better control intrahepatic tumors for hepatocellular carcinoma(HCC)     patients who meet the inclusion criterion.The patients were divided into two groups, the     group A by TACE and the other group B by external- beam radiotherapy(EBRT) after 2 times     TACE. Then the therapeutic effects and toxicities of TACE and EBRT are evaluated during the     follow-up period. The study design plans to enroll 300 patients, and each group includes 150     cases.   "
12872|NCT03116945|"     The aim of the present study is to validate the uptake of novel, positron emitting     radiotracer, 68Gallium Citrate in hepatocellular carcinoma(HCC). The investigators also aim     to evaluate the sensitivity of 68Gallium (68Ga)-citrate positron emission tomography/computed     tomography (PET/CT) for the identification of intrahepatic HCC lesions in comparison with     existing modalities: computed tomography (CT) alone and magnetic resonance imaging (MRI). The     investigators expect that 68Ga-citrate PET/CT will offer a sensitive functional imaging     modality for identification of HCC lesions in the liver. The investigators intend to use the     results of this preliminary study to fuel further studies in the utility of 68Ga-citrate     PET/CT for HCC treatment monitoring.   "
12873|NCT03116932|"     The target population for this project will be men-who-have-sex-with-men (MSM) at high risk     of HIV acquisition   "
12874|NCT03116919|"     White potatoes have recently been allowed back in the cash value voucher of the government     food stamp program after it was stated that there were no known adverse health effects of     potatoes. However, the association of potatoes with heart health, especially elevated blood     pressure is not known. This study will examine the effects of potatoes on blood pressure in     different populations of adults and children, and assess, in a feeding trial, the effects of     an additional serving of potatoes per day on the possible mechanisms that link potatoes to     high blood pressure. The investigators will also analyze the intake of potatoes in     participants of the government food stamp program.   "
12926|NCT03116230|"     The objective of this study is complete a longitudinal cross-over clinical study to     investigate the effect of treatments for knee pathology, including cutaneous stimulation     (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair     ascending and descending), muscle function, and pain/function.   "
12876|NCT03116893|"     The primary objective of this trial is to investigate the relative bioavailability of BI     685509 given alone under fasted conditions (Reference, R) compared to the intake after a high     fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under     fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted     conditions (Test 3, T3).      The secondary objective is the evaluation and comparison of several pharmacokinetic     parameters between the treatments.   "
12877|NCT03116880|"     Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order     to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate     a navigation road map by registering the intraoperative images with preoperative computed     tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions     for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to     register (fuse) the preoperative and intraoperative imaging to each other, a registration     algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it     fails the road map cannot be used for intraoperative navigation. The purpose of this study is     therefore to evaluate two different 3D registration algorithms with regard to registration     accuracy.   "
12878|NCT03116867|"     Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller     ball electrode.   "
12879|NCT03116854|"     Beta Blocker therapy is a mainstay of treatment following acute coronary syndromes (ACS),     particularly acute myocardial infarction (MI). Studies have repeatedly demonstrated the     benefit of Beta blocker therapy following either ST-segment elevation myocardial infarction     (STEMI) or non-ST-segment elevation ACS,and Beta blocker therapy has been a performance     measure used to grade hospital performance by the Centers for Medicare and Medicaid Services     and Joint Commission on Accreditation of Healthcare Organizations.Although the benefit of     Beta blocker therapy has been clearly demonstrated, the doses that have been used in many of     these studies are significantly higher than those typically used currently in clinical     practice.The benefit of Beta blockers has been ascribed to dose-related heart rate     reduction,although alternative mechanisms for their benefit have also been proposed.In     addition, the classical Beta blocker trials were performed decades ago, before the modern     therapeutic era,which includes reperfusion therapy, potent antithrombotics, and statins. This     raises the question of whether titration of Beta blocker therapy to the high doses that had     been previously studied provides substantial incremental benefit in current clinical practice     over the more frequently prescribed and clinically tolerated doses of Beta blockers.Moreover,     a recent study has reported that high-dose Beta blockers were not superior to low-dose Beta     blockers,aprovocative finding requiring validation. And until now, there has been no registry     on patients with ACS about Between Beta-blocker Treatment in Henan, the most populated (about     100 million) and predominantly rural (66%)province in central China.      This multicenter, prospective, observational study is aimed to analyze the application status     and long-term prognostic beneﬁt of beta-blockers in patients with acute coronary syndrome.   "
12880|NCT03116841|"     The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on     sleep disturbance of patients with reflux esophagitis, who have heartburn and/or     regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the     maintenance treatment with PPI other than vonoprazan.   "
12882|NCT03116815|"     Control of hypertension remains one of the most important interventions available to     clinicians to reduce risk of cardiovascular disease, kidney disease and stroke. Self-measured     home blood pressure monitoring plus additional support has been shown to reduce blood     pressure in adults with previously uncontrolled hypertension. Most previous studies have     utilized healthcare personnel to facilitate communication of home blood pressure levels to     physicians and did not provide methods to directly transmit self-measured blood home blood     pressure levels to physicians via the electronic health record. Emerging technology now     provides the ability for patient's to upload self-measured blood pressure levels into their     own medical record which may eliminate the need for additional health personnel. This study     will examine the feasibility, patient adherence and physician and patient perceptions of a     web-based application which will facilitate direct input of self-measured home blood pressure     levels and patient reported symptoms directly into the electronic health record with message     alerts to the provider for hypertension management. Up to 10 Loyola primary care physicians     and 20 of their respective patients age 50 years and older who have a smart phone device or     home computer and have treated hypertension will be enrolled. The study will utilize the     existing web-application called MyChart. MyChart is the name of the web-based application and     it is not an acronym. Enrolled patients will download the existing MyChart web-based     application on their smart phone device or home computer and will record home blood pressure     measurements using their home blood pressure machine into their smart phone application. The     MyChart application is available to all patients receiving care in the Loyola Health Care     System. The blood pressure readings and patient reported symptoms will then be available for     their physicians to review within the electronic health record. After using the web-based     application for two months, both patients and physicians will be asked to participate in     focus groups and interviews, respectively, to determine their perceptions and satisfaction     with the web-based application. Data from this feasibility study may be used to guide a     future clinical trial of hypertension management that examines the effectiveness of the     MyChart web-based application for frequent blood pressure monitoring compared to standard     care.   "
12945|NCT03115983|"     The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to     evaluate the safety and effectiveness of decompression and stabilization with the Empirical     Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar     interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of     lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal     stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF     subjects.   "
12883|NCT03116802|"     Since the 1st pandemic of the 21st century caused by SARS coronavirus, the world has     experienced outbreaks of swine origin H1N1 influenza, Ebola and Zika viruses, which have all     resulted in global health crises. Rapid mass vaccination with an effective vaccine such as a     live attenuated vaccine, of vulnerable immune-naïve populations to establish herd immunity is     an approach to control outbreaks. Such live attenuated vaccine had been used with great     success in sporadic yellow fever outbreaks and recently successfully employed in Ebola field     trial, both of these diseases have the potential for pandemic spread. Indeed, live attenuated     vaccines have proven especially effective in controlling childhood diseases and have even     succeeded in eradicating polio and measles from most parts of the world. However, deployment     of such vaccines for pandemic control cannot be limited to children but must include adults     in order to rapidly elevate herd immunity rates to halt transmission. Vaccinating adults may     produce efficacy rates significantly different to those observed in children due to the     prevalence of chronic diseases and their associated metabolic complications. Presently, there     are 1 billion people who are overweight, many suffer from concurrent metabolic disorders. As     activation of the adaptive immunity is reliant on a robust innate immune response to     vaccines, metabolic disorders and long-term anti-inflammatory therapy with interventions such     as statins may reduce vaccine immunogenicity resulting in suboptimal efficacy in this     subpopulation. This study would therefore test the hypothesis that statins reduce live     attenuated vaccine immunogenicity. We will combine a clinical trial with systems vaccinology     approaches to define the impact statins has on the innate immune, B and T-cell responses to     live attenuated vaccination. Our study will thus extend upon another recently completed trial     by us and will provide new insights into the determinants of vaccine efficacy in a rapidly     growing and aging population globally   "
12884|NCT03116789|"     The purpose of this study is to analyze the ameliorative effects of oral probiotics on     bacterial vaginosis.   "
12885|NCT03116776|"     This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry     eye syndrome compared with sodium hyaluronate eye drops.   "
12886|NCT03116763|"     The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to     manage their arthritis well and can support them emotionally and socially. This study will     compare two groups of teens: those who are in the iPeer2Peer Program and those in the control     group (no mentor).   "
12887|NCT03116750|"     The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is     intended to be used for the percutaneous transluminal removal of fresh thrombotic or     thromboembolic material from native blood vessels (or vessels fitted with stents, stent     grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral     circulations.      CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of     emboli from blood vessels during potentially embolizing procedures on the patient.      ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the     effectiveness and safety in the removal of thrombi in veins is assessed under real life     setting.   "
12888|NCT03116737|"     The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical     Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear     pain.   "
12889|NCT03116724|"     Total of 89 patients undergoing elective cardiac surgery will be enrolled.      Right CVC insertion begins at their intersection of the cricoid cartilage level and the     triangular point where the sternal head of the SCM muscle meets the clavicular head. After     insertion the central venous catheter through the right internal jugular vein and positioning     it, the location of the tip of the central venous catheter will be confirmed by TEE.   "
12890|NCT03116711|"     The purpose of this study is to determine the effects of diet type selection based on     response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success     to a weight loss and exercise program.   "
12891|NCT03116698|"     Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to     treatment in one of four arms.   "
12892|NCT03116685|"     This study will evaluate the efficacy and safety of OC5 in patients with PH.   "
12893|NCT03116672|"     Aim. To compare the outcome of preoperative administration of single-dose ketorolac,     non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with     irreversible pulpitis and apical periodontitis.   "
12894|NCT03116659|"     Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the     skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that     typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The     incidence of MF is about 1/100,000. Skin lesions tend to appear before the diagnosis of CTCL     is made by several years. Early skin lesions may look like any dermatitis, eczema, or     psoriasis, leading to delays in the diagnosis.      Inflammation secondary to bacterial infection is thought to contribute to the T-cell     proliferation in this type of cutaneous T-cell lymphoma. Antibiotic use for other purposes     has shown to reduce the inflammation and size of lesions in CTCL patients. There has been     limited studies with the use of antibiotics as direct treatment for this cancer.      Host immunity is important in decreasing cancer development and progression. Imiquimod is a     molecule that stimulates host immunity to reduce the progression of CTCL. There is strong     evidence of clinical efficacy such that the National Comprehensive Cancer Network (NCCN)     guidelines recommend Imiquimod for CTCL. Imiquimod is available in generic form, making it     unlikely to be registered specifically for CTCL, despite its efficacy.      Additionally, imiquimod is considered a first line treatment according to National     Comprehensive Cancer Network (NCCN) guidelines for the treatment of Mycosis Fungoides.      There are currently no studies that have been published that address treating CTCL patients     with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics,     and 2) enhancing the host immune system to destroy cancer cells. Our theory is if we treat     patient with 14days of antibiotics and 30 days of Imiquimod there will be significant     reduction in skin lesions.   "
12895|NCT03116646|"     The family has a primary prescription in the identification of the chewing disorder in     children to plan appropriate rehabilitation program and implementation of the training.     Therefore, it is very important to investigate the validity and reliability of classification     systems that can be applied by parents. The purpose of this study is to determine the     validity and reliability of the reliability and validity of family report chewing evaluation.   "
12896|NCT03116633|"     This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared     with tissue biopsy in patients with advanced lung cancer   "
12897|NCT03116620|"     We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and     investigate reliability of the Karaduman Chewing Performance Scale (KCPS).   "
12946|NCT03115970|"     Capillary or venous lactate level evaluation in prehospital care could be simple and     beneficial tool for optimising prehospital care in patients with severe trauma.   "
12898|NCT03116607|"     A randomized clinical trial with two parallel groups (control and intervened) in the     Emergency Department (ED) at the Clinical Hospital of the University of Chile will take     place. The sample will be of 996 patients (498 per group).      The control group will receive hospital care and discharge plan usual, while the intervention     group also receive a Program of Pharmaceutical Interventions while in the service and at     discharge, which includes an analysis of the therapy recommended by the physician, assessing     the safer alternatives for the patient population and the special conditions of their     pathology, emphasizing evaluations of effectiveness, safety and tolerability of medication,     drug interactions, potential adverse events, dose adjustments as needed according to the     patient's condition ; verification that the administration is optimal, including choosing the     best route to this and the time when the drugs are infused into the patient.Interventions     aimed at patient occur during the stay and at discharge, focusing on clarifying     administration regimens, reasons for using drugs, prevent drug-related problems, clarify     doubts and educate about pharmacotherapy and make a reinforcement of adherence.      The selection and patient recruitment will take place during the first hour of admission to     care box, where they were invited to participate and signed informed consent.      In both groups, a doctor and a pharmacist, blind to treatment assignment, will gather     information during the stay, discharge and post-discharge, the latter by telephone 30 days     after discharge from the ED, in this second interview also verify the existence of a     readmission and / or unscheduled medical consultation. In addition, discharge of each patient     satisfaction was measured with respect to the service received by a user satisfaction survey     applied by external and impartial staff. In addition, two independent trained evaluators     (Emergency Medical and Pharmaceutical Chemistry), blinded to treatment assignment, evaluate     the background of each case and by consensus allocated the presence of problems related to     drugs, and classified as preventable or not preventable, according severity.      X2 test or Fisher exact test was used to test the hypothesis that the Programme of     Pharmaceutical Interventions decreases at least 30% the user dissatisfaction compared with     usual care in the ED.   "
12899|NCT03116594|"     This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to     Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay).     Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered     with single dose of vaccine which is randomly assigned.   "
12927|NCT03116217|"     Validate the use of fetal urine peptidome-analysis for the stratification of fetuses with     Posterior Urethral Valve for post-natal renal function.   "
12900|NCT03116581|"     The study aimed to understand how payoffs for others influence perceptual decision making.     The research consists in testing how varying monetary payoffs for another modify the     perceptual decision making processes. The use of drift diffusion models on a random dots task     enable the characterization of the decision parameter(s) that are modulated when a decision     is made to win payoffs for others as compared to decisions for self-benefits. Once the     parameter revealed through behavioral experiment, neuroimaging is applied to find the neural     correlates of the effects of taking others into account in the decision making process.   "
12901|NCT03116568|"     Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are     caused by the loss of mucosal tolerance towards the commensal microbiota resulting in     inflammatory responses.      Identifying intestinal bacteria in mother and newborn of both IBD and Control groups allow us     to understand the change of bacterial composition human microbiome in the gut during     pregnancy and childhood development.   "
12902|NCT03116555|"     After failure of first-line therapy, single agent of irinotecan is used as second line     treatment in locally advanced or metastatic gastric or gastroesophageal junctional     adenocarcinoma. The purpose of this study is to evaluate it there will be more benefit with     irinotecan plus apatinib.   "
12903|NCT03116542|"     The main purpose of this project is to study the uptake pattern of FLT-PET in cases, and it     is value in assessing the malignant hematopoiesis in cases of Pre-PMF and ET, regarding     diagnosis, staging and monitoring response to therapy. Identifying different patterns of     uptake in patients with Pre-PMF and ET in various clinical settings.      Evaluating FLT-PET as a novel non-invasive technique in cases with Pre-PMF and ET, in     comparison to the standard bone marrow biopsy about disease diagnosis, assessment of disease     activity, detection of transformation, monitoring of treatment response and grading of     fibrosis.Study the ability of FLT-PET to differentiate between Pre-PMF and ET.      the investigators also aim to examine the association of FLT-PET uptake patterns with     different genetic makeup (JAK2 (Janus kinase 2), CALR (Calreticulin), MPL (myeloproliferative     leukemia protein), or Triple negative disease) or allele burden in cases of Pre-PMF and ET.   "
12904|NCT03116529|"     Chemotherapy is controversial for soft tissue sarcoma that has not yet metastasized. Surgery     and radiation are effective for local control, but there are no highly effective     interventions to prevent metastatic spread of soft tissue sarcoma. Immunotherapy has shown     promise in other types of cancer. Combining two types of immunotherapy agents with     preoperative radiation may help the immune system recognize the sarcoma and stimulate an     anti-tumor immune response.   "
12905|NCT03116516|"     This is a phase 1, open label, single-dose, crossover study to investigate the     pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine     and rosuvastatin in healthy male volunteers      Hypothesis: YHP1604 and telmisartan/amlodipine and rosuvastatin are showing equal     pharmacokinetics.   "
12906|NCT03116503|"     The purpose of the study is to describe the number of diagnosis of bipolar depression and     comorbid suicidal behavior according to the diagnostic criteria of the DSM-5.   "
12907|NCT03116490|"     The aim of this study is to figure out whether anesthesia type have an influence on the     prognosis of hip fracture surgery.30-day mortality and morbidity after the surgery are our     main observational index,and according to literature and our experience,regional anesthesia     may have a better prognosis after hip fracture surgery compared with general anesthesia.   "
12908|NCT03116464|"     Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of     the most stressful aspects of caregiving is the management of behavioral problems (e.g.     wandering, agitation, and sleep difficulties), which exacerbate health issues for both     caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver     stress and behavioral problems are often ineffective. Many caregivers do not realize their     interactions with PWD contribute to behavioral problems and thus do not ask for help to     improve their interpersonal skills. The aim of this project is to develop an assessment of     interpersonal skills deficits and a related treatment strategy to assist family caregivers of     PWD who are challenged by a lack of interpersonal skills and are not helped by existing     family caregiver treatments. This project, will develop and test (1) a video assessment of     caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and     (2) a family therapy for the interpersonal difficulties clinicians identify in the     assessment.   "
12909|NCT03116451|"     This study supports and promotes work well-being of nursing personnel from the perspective of     foot health in health care organizations. Half of the participants will receive an electronic     foot health education program to improve their foot self-care knowledge, while the other will     receive anything. The outcomes of this project include recommendations and tested educational     program to occupational health care for improving foot health of nurses.   "
12913|NCT03116399|"     The focus of the study is to evaluate the expanded version of PRISM 1.0 for a broad array of     seniors with different needs and circumstances. The aims of the study are to: 1) obtain     information on perceptions of the usefulness and usability of PRISM 2.0 and interface design     issues; 2) examine the impact of access to PRISM 2.0 on social connectivity, engagement,     social support, and perceived loneliness; 3) examine the impact of access to PRISM 2.0 on     perceived isolation, well-being, and quality of life; 4) examine the impact of access PRISM     2.0 on computer attitudes, self-efficacy, technology proficiency and technology uptake; 5)     gather data on usefulness of system features and if these vary by living condition; and 6)     examine, in our statistical models, the influence of factors such as age, cognitive     abilities, ethnicity, education on system use and outcomes.   "
12914|NCT03116386|"     In the context of reduce staff for supervision of dependent elderly, automated risk alert     systems could have a positive impact on the organization of night care by better targeting     monitoring. Residents' sleep could be less affected with use of automatic alert system than     by systematic monitoring visits. One study shows an improvement in the humor of residents     after the use of such a system.      The hypothesis of the study is that the use of a bed-raising detection system linked with the     activation of a lighting environment and a caregivers alert system (Etolya-F® gerontechnology     device, Anaxi Technology Company) would reduce intervention time in this population, thus     limiting the time spent on floor and its physical and psychological consequences.   "
12915|NCT03116373|"     This study evaluate the secondary shifting of the tracheal tube when the head is moved under     general anaesthesia. Two sites of fixation (the maxilla and the mandible) are tested in a     prospective, double blind, randomized and crossover designed study.      The study test the hypothesis that taping the tracheal tube on the mandible better prevents a     secondary tube move.   "
12916|NCT03116360|"     Hypothesis: Diagnostic ultrasound is an appropriate screening test for acute stress fracture     in the lower extremity and is superior to x-ray.      Primary Aims: To determine if diagnostic ultrasound is an appropriate screening test with     high sensitivity and at least moderate specificity for the identification of acute stress     fractures of the lower extremity.      Methods: In this double-blind, prospective clinical study, subjects (age 14 years and up)     suspected to have an acute stress fracture of the lower extremity will be recruited from the     Sports Medicine clinic at the University of Virginia Health System in the Department of     Physical Medicine & Rehabilitation. Subjects will undergo the traditional diagnostic     algorithm including screening x-ray as part of standard care. Subjects will then undergo a     confirmatory MRI of the region of concern if the initial x-ray was negative as part of     standard care. Any subject who does not require an MRI for clinical purposes (initial X-ray     was positive) will have one completed for research purposes. All subjects will also undergo     diagnostic ultrasound performed by a separate, blinded physician competent in diagnostic     ultrasound for research purposes. A statistician in the Department of Public Health at the     University of Virginia will be performing statistical analysis during data analysis. Findings     will be analyzed using a McNemar chi-square test to evaluate for significant differences     between the sensitivities of ultrasound and x-ray.   "
12917|NCT03116347|"     The purpose of the study is to acquire additional data on safety, tolerability and     immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary     Immunodeficiency Diseases (PIDD)   "
12918|NCT03116334|"     In this study the investigators will interrogate an existing data set to examine whether     genetic variants contribute to an inverse association between weight status and cognitive     function. Investigators hypothesize that body mass index (BMI) will be inversely related to a     number of variables measuring cognitive function, and that that this inverse relation will be     at least partially attributable to genetic variants which influence both BMI and cognition.   "
12919|NCT03116321|"     The purpose of this study is to determine whether the test product, eslicarbazepine acetate     800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product,     eslicarbazepine acetate 800 mg tablets (current Active pharmaceutical ingredient (API) source     - Marketed formulation (MF)) (Reference, Treatment C), are bioequivalent and to demonstrate     dose equivalence between eslicarbazepine acetate 4 x 200 mg tablets (test 2, TBM Treatment B)     and eslicarbazepine acetate 800 mg tablet (Reference).   "
12920|NCT03116308|"     The purpose of this study is to investigate the effect of food on the     catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC,     development code BIA 9-1067) in healthy subjects and to characterize the effects of food on     the pharmacokinetics (PK) and tolerability of OPC after repeated doses.   "
12921|NCT03116295|"     The purpose of this study is to evaluate the bioavailability and the bioequivalence between     two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage     strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions     in healthy male and female subjects.   "
12922|NCT03116282|"     The study evaluates whether the introduction of e-alcohol therapy (alcohol therapy delivered     via video conference) can break with some of the barriers related to alcohol treatment and     thereby appeal to people with a problematic alcohol use (Alcohol Use Disorder Test score ≥     8). The study aims to evaluate the effect of e-alcohol therapy on initiation, treatment     compliance and alcohol intake as compared to treatment as usual .   "
12923|NCT03116269|"     Patients presenting with acute cerebral ischemic events are randomly assigned into aspirin     (n=40) or cilostazol (n=40) group in a double-blinded manner. FMD is measured as a primary     outcome at baseline (T0) and 90 days (T1). Serious and non-serious adverse events were     described.   "
12924|NCT03116256|"     The aims of this project are: to investigate the impact of VLCD on control of muscle protein     synthesis, muscle structure and function, cardiac function (ejection fraction), vascular     function (blood flow and capillary function), overall physiology status (cardiopulmonary     function) and metabolic status (insulin sensitivity) in overweight and obese middle-aged male     with or without exercises.      There are 3 groups for the study, to which each participant will be randomly assigned into     one of either:        1. VLCD only        2. VLCD with resistance exercise training (RET)        3. VLCD with high intensity interval training (HIIT) The total duration of the intervention          is six weeks, with exercises taking place three times per week at the research unit          under close supervision by trained staff.   "
12925|NCT03116243|"     The MSHS Study is a nationally representative study commissioned by the U.S. Office of Health     and Human Services' Administration for Children and Families that will describe the     characteristics and experiences of the children and families who enroll in MSHS and the     practices and services of the MSHS programs that serve them. The MSHS Study draws heavily on     the Design for MSHS Survey Report (2011) and is informed by the current context of key policy     and programmatic issues and broader issues impacting the lives of migrant and seasonal     farmworkers and their families.      The MSHS Study has two components: a Program/Center component and a Classroom, Family, Child     component that are based on distinct samples. The first component is off-site and consists of     mailed surveys that will be sent to the universe of MSHS program directors and a     representative subset of center directors to provide information on program and center     operations. The second component consists of onsite data collection - including classroom     observations, surveys with teachers and assistant teachers, parent interviews, teacher and     parent child reports, and direct child assessments - with a nationally-representative sample     of centers, classrooms, families and children.      Once data are collected, the study will address a set of research questions that can be     summarized into three broad categories: (1) What are the characteristics of MSHS programs,     families, and children? (2) What services do MSHS programs provide, what instructional and     language practices are used, and what is the quality of MSHS classrooms? and (3) What are the     associations between MSHS characteristics and child/family well-being?   "
12928|NCT03116204|"     A person's dependency is defined as the total or partial inability to perform without helps     the necessary activities of daily life due to activity limitations in the usual environment.     The consequence is a restriction of participation. In physical and Rehabilitation Medicine     (PRM), dependency impacts the healthcare team activity at several levels: patient's referral     and care plan, conditions of home return and resumption of course of life, burden of care     assessment and care teams management...      The main goal of this project is the validation of a score assessing physical and cognitive     activities of patients in follow-up care and rehabilitation (FRC) departments based on the     ICF model (International Classification of Functioning, Disability and Health) : the SOFMER     Activity Scale (SAS).      We want to propose a French generic scale allowing quantifying precisely the dependence and     burden of care of patients in FRC departments. This scale needs to be valid, easy to apply,     easy to learn, reproducible, sensitive to change and common to adult subjects, children and     elderly.   "
12929|NCT03116191|"     The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the     treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.   "
12930|NCT03116178|"     Intraoperative fluid given according to BMI in group B and according to pulse oximeter-     derived pleth variability index(MASIMO RAINBOW PULSE CO OXIMETRY) in group G. Comparison of     haemodynamics, urine output,blood lactate levels, blood sugar, flap sugar and coagulation     profile between the two groups.   "
12931|NCT03116165|"     This study will examine the use of modified prolonged exposure therapy in trauma patients     recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress     disorder.   "
12932|NCT03116152|"     Efficacy and safety evaluation of IBI308 versus paclitaxel/irinotecan in patients with     advanced/metastatic esophageal squamous cell carcinoma after failure of first-line treatment:     a randomized, open-label, multicenter, phase 2 study   "
12933|NCT03116139|"     Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most     common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can     cause kidney problems in some patients, called contrast-induced nephropathy or CIN. This is     a kidney problem that usually does not make patients feel any differently or change how they     urinate. Most of the time, it can only be found by testing blood several days later. This     kind of kidney problem can be very mild and some patients will never have any symptoms,     rarely these problems can be severe. Some patients can also have similar kidney problems for     many other reasons (reactions to medications, blood pressure problems, etc.) and can even     happen in patients that do not get IV dye. That is why doctors are not sure exactly who will     have these problems or if using a test that does not use IV dye can prevent this kidney     problem. The VQ scan uses a different medication through the IV that is not IV dye and has     not been linked to kidney problems. The purpose of this study is to learn if using the test     that does not use IV dye (the VQ scan) instead of a CT scan in some patients can help to     prevent kidney problems.   "
12934|NCT03116126|"     NorAD is a clinical trial funded by the UK National Institute of Health Research. In this     trial the investigators will assess whether a long-acting preparation of guanfacine, a drug     used to treat Attention Deficit Hyperactivity Disorder in children, can improve thinking     (particularly attention) in Alzheimer's Disease when it is added to the standard     NICE-approved drugs that are normally used in this condition.      This is a randomized clinical trial designed to evaluate the efficacy of extended-release     guanfacine as an add-on therapy in AD, and whether it improves cognition compared to standard     cholinergic therapy alone.   "
12935|NCT03116113|"     A clinical trial of AAV-RPGR retinal gene therapy for patients with X-linked retinitis     pigmentosa   "
12947|NCT03115957|"     Patients will be randomized to early PN group or late PN group at day 3 after abdominal     surgery. Patients will receive supplemental parenteral nutrition or not within 7 days after     abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN     or oral or patients are discharged from hospital. The primary and secondary outcomes will be     collected.   "
12948|NCT03115944|"     A Multi-Center Pilot Study to Assess the Safety and Efficacy of the VShape Ultra UltraSpeed     Handpiece for Abdomen Circumference Reduction   "
12949|NCT03115931|"     It is a study to evaluate the relationship between preoperative nutritional assessment and     clinical outcomes and to explore the effect of preoperative nutritional support on clinical     outcomes in patients after abdominal operation.   "
12936|NCT03116100|"     Behavioral disorders of psychiatric or neurological origin in the elderly are an emerging     public health problem. Its management can include a prescription of psychotropic drugs     (anxiolytics, hypnotics, neuroleptics, antidepressants for the most part). Many studies     highlight the misuse of psychotropic drugs in this specific and vulnerable population, as     well as the need for targeted actions.      As for neuroleptics, there is a deleterious over-prescription in the so-called productive     behavioral disorders (cries, agitation, aggressiveness, ambulation), in particular in the     patient with Alzheimer's disease (80% of patients) or related. The same applies to behavioral     disorders in an acute episode of confusion, which also constitute a situation for the     prescribing of psychotropic drugs in the elderly. The frailty of the elderly associated with     neuroleptics is the cause of a significant iatrogenic (falls, confusions, excessive sedation,     etc.), iatrogeny is largely avoidable.      There is little data on the representation of behavioral disorders in the elderly, whereas     the recognition and management of behavioral disorders are functions of the tolerance of the     entourage and the training of the caregivers. Significant data exist in the literature about     diagnosis, risk factors, factors favoring or triggering behavioral disorders and somatic     pathologies to be sought urgently.      The available recommendations on the drug treatment of behavioral disorders are complex and     inappropriate in light of new data, including the dangerousness of psychotropic drugs. The     deleterious effect of long-term drug treatments is proved. There is no validated drug     strategy, especially in acute confusions of the elderly.      One study showed that there was a change in the type of neuroleptic prescribed between 2003     and 2010. Half of the general practitioners studied during this period switched from a     first-generation neuroleptic to a second-generation neuroleptic. Nevertheless, the type of     molecule chosen remains at the discretion of the treating physician or even required a     psychiatric opinion or a passage in the emergencies. In the case where the practitioner     initiates a prescription in office, in the home or in EHPAD, certain situations require the     choice of a neuroleptic with or without pre-therapeutic assessment.   "
12964|NCT03115736|"     The investigators aim at describing changes in renal glomerular and tubular function with     after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal     dysfunction and to assess the virological efficacy of TAF on HBV infection.      The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS)     who are under active care and have been on a stable, TDF-containing ART regimen for at least     6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min     and 90 ml/min will be included. All individuals who agree to participate will be switched     from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will     be followed for 48 weeks after the treatment change.   "
12937|NCT03116087|"     The overall objective of this study is to establish if testosterone replacement in     post-menopausal women with low testosterone levels and stress urinary incontinence (SUI) will     lead to improvement in symptoms of SUI.      This study is a prospective, randomized, double-blind, placebo-controlled, parallel-group,     clinical trial and will involve sixty (60) post-menopausal women with clinically diagnosed     stress urinary incontinence and low testosterone concentrations. These subjects will enter     the control period, which involves the baseline measurements of pelvic floor muscle volume     and strength, amounts of urine leakage in 24-hour period, urodynamic parameters, and quality     of life using Incontinence Impact Questionnaire and Urogenital Distress Inventory. Subjects     are then randomly assigned to either placebo (30 subjects) or 300 mcg/twice-weekly     testosterone patch (30 subjects) group. Both the subjects and investigators will be blinded.     The duration of the testosterone/control study will be 36 weeks, with weeks 1-3     screening/control period, 4-28 application of placebo or testosterone patches and 29-36     recovery time/assessment of effects.   "
12938|NCT03116074|"     The goal of this study is to implement and evaluate an interactive patient-centered discharge     toolkit (PDTK) to engage patients and care partners in discharge preparation and     communication with providers after discharge. The aims of this study are to:        1. To refine and implement an interactive PDTK on a general medicine unit that patient and          caregivers can use to prepare for discharge and communicate with key providers during          the transition home.        2. To evaluate the impact of the PDTK on patient activation (primary outcome). Patient          reported self-efficacy after discharge; post-discharge healthcare resource utilization;          and perception of patient-provider communication will be measured as secondary outcomes.        3. To identify barriers and facilitators of implementation, adoption, and use of the PDTK          by patients, caregivers, and providers using qualitative and quantitative methods.   "
12939|NCT03116061|"     The European General Practitioners Research Network (EGPRN) designed and validated a     comprehensive definition of multimorbidity using a systematic literature review and     qualitative research throughout Europe. This definition was tested as a model to assess     decompensation in multimorbid outpatients.      The objective is to assess which criteria in the EGPRN concept of multimorbidity could detect     decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess     whether a large scale cohort with FPs would be feasible.   "
12940|NCT03116048|"     Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia     technique that provides post-surgical pain relief for patients undergoing breast surgery.     Post-procedural pain relief is known to diminish persistent pain. In this prospective     follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is     effective in reducing persistent post-procedural pain after breast cancer surgery in female     patients.      Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or     tumorectomy with sentinel node or axillary node dissection under general anesthesia were     randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients     were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain     survey.   "
12941|NCT03116035|"     This is a prospective randomized control trial to compare the impact of two different types     of pre-operative web-based breast cancer information on the quality of patient decision     making. Patients are emailed web-based information prior to the surgical consultation.     Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2)     immediately following the consultation.   "
12942|NCT03116022|"     Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication     and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may     control this complaint. However, there are limitations on its use, especially in patients     with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to     assess the impact of local estriol therapy in postmenopausal women complaining of coital pain     and to assess serum concentrations of estriol in these women after estriol use.     One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three     groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night -     estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the     vagina every other night - estriol distal group (DEG), gel group (GG) using water-based     during intercourse.   "
12943|NCT03116009|"     This will be a randomization of two groups of obese pregnant women into early screening for     diabetes mellitus at the time of their first or subsequent prenatal visits before 20 weeks of     gestation versus standard time of screening for diabetes at 24 - 28 weeks as it is done for     all pregnant women. The perinatal outcomes between the two groups will be compared to     determine whether early screening for diabetes in all obese pregnant women has a clinical     merit or significant.   "
12944|NCT03115996|"     To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous     (SC) doses and a multiple dose regimen.   "
12950|NCT03115918|"     The research design is a randomized prospective clinical study comparing the incidence of     Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.   "
12951|NCT03115905|"     This is a staged registry study of early treatment strategy management of acute aneurysmal     subarachnoid hemorrhage(aSAH) among different economic development levels areas in China.      First stage, the study will investigate and register the basic information of emergency     treatment management for the acute aSAH in 20 different grade centers located in different     economic levels districts including Northeast part, Northern, Eastern, South-central,     Northwest, Southwest and Qinghai-Tibet of China. Comparing the the outcome of acute aSAH to     find the critical factors to affect it by statistical analysis. Then,the investigators will     offer some suggestions to adjust the measures to improve the efficacy of emergency medical     service for acute SAH.      Second stage, to evaluate the outcome after applying the new suggestion of self-control     methods.      The investigators hypothesis that there is an appropriate green pathway in different     districts to shorten the rescuing time, improve the curative effects.   "
12952|NCT03115892|"     The Effect of Mouthwash Containing Green Tea With Aloe Vera and Chlorhexidine Mouthwash on     Oral Malodour Among a Group of Egyptian Children: Randomized Clinical Trial   "
13001|NCT03115255|"     To determine the serum concentrations of ranibizumab and vascular endothelial growth factor     (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab   "
12953|NCT03115879|"     Introduction: Lower extremity weakness associated with musculoskeletal pathology can cause     activity limitations. Physical therapy intervention in the form of exercise is commonly     directed at improving muscular performance, however, neuromuscular adaptations may limit the     effectiveness of traditional strengthening exercises. Manual therapy techniques have been     used as a disinhibitory intervention to increase muscle activation and strength before     participating in strengthening exercises or performing functional tasks While there is recent     evidence to support joint mobilization as a valuable manual therapy disinhibitory     intervention Currently, there is no evidence to substantiate anecdotal experience that a     HVLAT hip distraction mobilization improves muscle performance in subjects with lower     extremity pathology and lower extremity weakness. The purpose of this study was to determine     if a HVLAT hip distraction mobilization would result in an immediate change of maximal force     output of the quadriceps, gluteus maximus and gluteus medius.      Methods: Forty individuals with a lower extremity pathology volunteered for this study.     Inclusion criteria were having a unilateral musculoskeletal pathology, being greater than 18     years of age, 10% decrease in muscle strength in symptomatic side compared to healthy side,     and absence of medical precautions that would prevent a maximal effort strength test and     exclusion criteria included individuals with a history lower extremity recent muscle or     tendon ruptures (within the past 6 months) and postoperative knee, hip and ankle surgery.     Demographic data, including diagnosis from referring physician were collected. All subjects     completed the Lower extremity function scale (LEFS). A single evaluator blinded to the     involved extremity was responsible for quadriceps, gluteus medius and maximus strength     analysis pre and post mobilization of both symptomatic and non-symptomatic sides. The subject     underwent the HVLAT hip distraction mobilization of the symptomatic side, and an immediate     re-assessment of strength of both symptomatic and non-symptomatic sides followed the     mobilization.   "
12954|NCT03115866|"     Rates of obesity and the metabolic syndrome are increasing in the young adult population     (years 18-28). Modifying diet, especially increasing fruit and vegetable intake, can help     assist in health maintenance and disease prevention. The purpose of this project is to     evaluate the impact of the FRUVEDomics behavior intervention on dietary behaviors and     metabolic parameters on young adults at-risk of disease. FRUVEDomics is an 8-week     free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and     driven by the Social Cognitive Theory, conducted in young adults (18-28 years old) at West     Virginia University. Individuals were recruited if they had pre-existing poor nutritional     habits. A metabolic syndrome risk screening score was given to participants at baseline to     measure risk status for chronic disease. Subjects were randomized into one of three     nutritional intervention groups: 1) FRUVED (50% fruit & vegetable), 2) FRUVED+LRC (50%     fruit & vegetable plus low refined carbohydrate), and 3) FRUVED+LF (50% fruit & vegetable     plus low fat). Anthropometrics, surveys, venous blood samples and body composition were     collected before and after the intervention. Group nutrition education including basic     nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and     grocery shopping tips were delivered to each participant group prior to the start of the     intervention. Participants underwent individual weekly consultations with a Registered     Dietitian Nutritionist using food logs, food pictures and receipt management, to assess     adherence and cost of the intervention.   "
12955|NCT03115853|"     Aliskiren (also called TekturnaTM) is a new drug for high blood pressure. Aliskiren works by     blocking the actions of a substance called renin. Renin is a natural substance in the body     that raises blood pressure. Renin is believed to contribute to the production of blood clots     by increasing the amount of a substance known as Plasminogen Activator Inhibitor or PAI-1.     This study will measure how aliskiren changes the amount of PAI-1 in the blood depending on     the time of dosing. The purpose of this study is to find out if it is better to take     aliskiren in the morning or at night.   "
12956|NCT03115840|"     Millions of older adults are hospitalized for a critical illness each year and although they     are more likely than ever to survive this illness, they commonly face significant morbidity     in the form of disabilities in basic self-care activities and in mobility in the months and     years afterwards. A better understanding of the underlying risk factors for disability     following critical illness is greatly needed, including the effect that activity during     hospitalization may have on these outcomes. Therefore, we designed the Measuring OutcomeS of     Activity in Intensive Care (MOSAIC) observational study to evaluate the relationship between     activity (measured more rigorously than in prior investigations) and disability, physical     function, and cognitive function in survivors of critical illness 3 and 12 months after ICU     discharge.   "
12957|NCT03115827|"     The purpose of this study is to find out whether droxidopa, a medication that increases     norepinephrine levels, may be effective in improving some aspects of cognition and movement     in Parkinson's disease (PD).   "
12958|NCT03115814|"     To investigate the safety of deep brain stimulation in the treatment of severe Alzheimer's     disease (AD); to investigate the effectiveness of deep brain stimulation in the treatment of     severe AD, i.e., effects of deep brain stimulation on cognitive function in patients with     severe AD and dementia grading; to investigate the effects of deep brain stimulation on     cerebral glucose metabolism in patients with severe AD.   "
12959|NCT03115801|"     The trial is open to patients who have metastatic renal cell carcinoma/urothelial (bladder)     carcinoma with at least 2 measurable sites of disease. All eligible patients will be randomly     assigned to immunotherapy(nivolumab/atezolizumab) versus immunotherapy     (nivolumab/atezolizumab) plus radiotherapy, 10 Gy x3 (conformally or by intensity modulation     radiation therapy/Image-guided radiation therapy (IMRT/IGRT) to maximally spare normal     tissue), to one of their measurable lesions.   "
12960|NCT03115788|"     Cognitive performance will be studied over time using an iPad game interface called the nine     choice human game (5CH) in normal volunteer subjects before during and after experimentally     induced thermal (cold or warm) pain or control (no intervention).   "
12963|NCT03115749|"     The exact origin of inflammatory bowel disease (IBD) is still unknown. The current hypothesis     is that IBD is secondary to an abnormal intestinal immun response directed to all or part of     the intestinal flora in genetically predisposed individuals. Several experimental studies     have demonstrated the ability of mesenchymal stem cells (MSCs) from bone marrow or adipose     tissue origin to control intestinal inflammation in animal models. However, to date, there     are no data regarding the functions of resident MSCs in the colon and small intestine of IBD     patients. We hypothesize that dysfunction of resident intestinal MSCs contributes to the     disruption of intestinal homeostasis in patients with IBD causing the development of     intestinal inflammation. The aim of this research project is to identify, describe and     characterize at the molecular and functional level MSCs of the colon and small intestine of     patients with Crohn's disease and ulcerative colitis and to compare them with a control     population.   "
13002|NCT03115242|"     This is a biomedical, single-center, and prospective study of a consecutive patients cohort     in acute ischemic stroke with carotid plaque.   "
12965|NCT03115723|"     Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary     angiographies (CAG) is a main indicator of quality of care and addresses economic issues. The     aim of this study is to quantify the frequency and analyse the types of rehospitalizations     and repeat revascularizations during one year after a PCI or a CAG. This information is     needed to organize the health care pathway and to identify preventable rehospitalizations.   "
12966|NCT03115710|"     Keratoconus is a ocular disease classified under ectatic diseases which often results in     bilateral and asymmetrical corneal distortion. It usually affects patients at young age and     can cause severe visual loss.      The overall goal of this study is to assess the prevalence of keratoconus (KC) in children     and adolescents in various regions of the world based on modern tomographic imaging methods,     and to verify whether the occurrence rates reported from literature should be corrected. Our     hypothesis is that the prevalence of the disease is much higher than that traditionally     reported.      At each site, corneal tomography examinations (Pentacam) will be performed bilaterally in     children and adolescents, who are not ill or with any ophthalmological symptom. The     population to be studied will be composed of children and adolescents on medical visits for     non-ophthalmologic reasons, aged between 6 and 20 years. Multiple cities, from different     continents (North America, South America, Asia and Europe) will participate.   "
12967|NCT03115697|"     Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017     Sample size-120 patients Methodology We will include consecutive with advanced hepatic     encephalopathy not responding to treatment of precipitants and on treatment with Lactulose     and Rifaximin for 48 hours .      Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm -     Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once     in 24 hours/or alternate days with an follow up for 5 days)   "
12968|NCT03115684|"     Pain in the emergency room is under documented and pain relief suboptimal. Data on nurse     driven analgesia in emergency department waiting rooms is lacking. The primary objective of     this study is to determine the proportion of patients in pain receiving pain therapy     administered by the triage nurse (prevalence study). The secondary objectives are to 1)     describe nursing practices in analgesia and adherence to the dedicated protocol; 2) to     determine the factors associated with the non administration of painkillers and for these     factors, to estimate the strength of the association   "
12969|NCT03115671|"     This research study is carried out to examine the effects of Phosphatidylserine-Omega 3     supplements (i.e., Vayarin) among children with Autism Spectrum Disorder (ASD) and ADHD.     Participants will be randomised either to receive the Vayarin treatment (Intervention group)     or to a Control group.   "
12970|NCT03115658|"     The purpose of this study is to learn more about encouraging physical activity among first     degree female relatives of women with breast cancer. Physical activity can decrease a woman's     risk of developing breast cancer, on average, by 20%; however, physical activity     interventions have not been developed specifically for first degree female relatives of     cancer patients, so currently, it is unknown whether standard physical activity interventions     are sufficient for these women or if first degree female relatives would benefit from an     enhanced physical activity intervention that addresses information about breast cancer risk     reduction. To obtain information about first degree female relatives preferences for a     physical activity intervention, this study seeks to have first degree female relatives of     breast cancer patients enroll in a standard physical activity intervention developed for     healthy men and women. After completion of the three month intervention, the women will be     asked to participate in two, one-hour long focus group with 5-7 other participants. The first     focus group is to discuss aspects of the physical activity intervention that they liked and     did not like, as well as things they think may have enhanced the intervention and made it     more relevant to other first-degree relative of breast cancer patients. In the second focus     group, participants will be shown enhancements that were developed based on information     gathered from the first focus group. Participants will be asked for their feedback on the     newly developed enhancements.   "
12971|NCT03115645|"     Long-term sitting has been associated with multiple health risks. To reduce sitting time for     office workers in a Dutch insurance company, an intervention will be implemented. The goal of     this study is to evaluate this intervention on the short term (3 months) and long-term (12     months).   "
12972|NCT03115632|"     There are two aims for this study. The purpose of this study is to determine the effects of     body weight and hormones on airway fibrosis (scarring) and lung function in obese & lean     asthma subjects compared to obese & lean non-asthma subjects (Aim 1). And in obese subjects     with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing     bariatric surgery (Aim 2).   "
12974|NCT03115606|"     In patients with cervical spine disorders or hernia, in-line stabilization and immobilization     during tracheal intubation is used to avoid neck injury. With direct laryngoscopy     cranio-cervical motion can result injury. The aim of the study is to compare two different     device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.   "
12975|NCT03115593|"     Endometrial cancer is the most common pelvic gynecological cancer in so-called developed     countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It     preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95%     for early forms, which represent more than 70% of diagnoses. The main risk factors are     obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing     incidence. Half a million new annual cases are expected in 2035.      The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the     disease is estimated between 10 and 15%. Currently the recommendations are to make an     evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type     is the main predictor of the severity of the disease and acts as guideline for the     treatment.It is therefore essential to have precise biopsy results before starting     therapeutic management.      The most widely used technique is the blind biopsy by aspiration using a pipette because it     is inexpensive, easy, without any specific equipment. However, recent studies showed that     this technique has a poor sensitivity in the target population of postmenopausal women. Other     studies have shown that targeted biopsies under hysteroscopic control could have a much     higher sensitivity.      The main objective of this study is thus to compare the performance of the targeted biopsy     under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the     diagnosis of endometrial cancer.   "
12976|NCT03115580|"     The purpose of this study is to predict any changes in the side branch after stenting the     main branch blood vessel using three dimensional intravascular images. (Frequency domain     optical coherence tomography FD OCT).      Optical coherence tomography (OCT) is an established medical imaging technique that uses     light to capture high-resolution, three-dimensional images of blood vessels. These images     will be used before and after implanting the stent in the main blood vessel. Fractional Flow     Reserve (FFR) test, which makes it possible for the interventional cardiologist to calculate     blood flow across an area of a coronary artery, will be done after stenting and will help to     determine if there are any changes in the side branch blood flow.   "
12977|NCT03115567|"     This randomized, controlled, phase II clinical study is designed to assess the efficacy of     preemptive treatment with topical steroids in preventing the papulopustular eruption induced     by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients.     Participants will be followed up for 6 weeks of twice daily application of triamcinolone     cream to the face, chest, and back.   "
12978|NCT03115554|"     There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which     includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in     the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter     ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.   "
12979|NCT03115541|"     The purpose of this study is to determine the incidence of post-operative venous     thromboembolism (VTE) in patients undergoing major esophageal resection for malignancy.   "
12980|NCT03115528|"     The primary objective is to identify the difference in the estimation of prognosis of     advanced cancer patients between medical oncologists and palliative care physicians.   "
12981|NCT03115515|"     In women who require thyroid hormone replacement medication, the investigators will compare 2     ways to adjust thyroid medication during pregnancy to determine superiority in maintaining     optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly     in pregnancy and it is important that blood levels of thyroid hormone remain normal so the     fetus, which cannot make its own thyroid hormone has enough for early prenatal development.     This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with     known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be     randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is     confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid     medication every 2-4 weeks in micrograms per day based on results of blood tests. The     investigators will compare thyroid hormone levels throughout pregnancy between the groups of     mothers to determine which method is superior in meeting the increased thyroid hormone     requirements during pregnancy.   "
12982|NCT03115502|"     Obese patients have increased cardiovascular risk and target organ damage (TOD) as compared     to people with normal weight. Weight loss reduces cardiovascular risk and TOD. These changes     have been associated mainly to changes in inflammatory and pro-atherogenic markers. Office     peripheral blood pressure (BP) appears to decrease after bariatric surgery, but information     on changes in 24h-ambulatory-BP-monitoring (24h-ABPM) and central-BP(cBP), or about the     possible role of renin-angiotensin-aldosterone (RAAS), serotonin(STS) and     endocannabinoid(ECS) systems is scarce. Our hypothesis is that the hemodynamic changes     mediated by alterations in the RAAS, STS and ECS after weight loss are also responsible for     the reduction of TOD.   "
12983|NCT03115489|"     The study will investigate the efficacy of the NMDA receptor antagonist ketamine as a first     line agent in refractory status epilepticus versus traditional general anesthetic agents used     for burst suppression that target the GABA adrenergic receptors.   "
12984|NCT03115476|"     One of the main reasons for treating AK is the wish to lower the risk of progression of AK to     SCC. This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk,     but since patients can have dozens of AKs and the disease is chronic the cumulative risk for     a patient can be substantial.      In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the     incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients     over a period of 2 years, so that the total follow-up time for each patient will be 3 years     and 2 months.   "
13088|NCT03114111|"     The purpose of this study is:        1. To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic          dermatitis.        2. To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis          before and after treatment.        3. To determine how PDT alters sebum secretion rates in subjects with seborrheic dermatitis          before and after treatment.      The researchers hypothesize that PDT will be efficacious in the treatment of seborrheic     dermatitis.   "
12985|NCT03115463|"     The purpose of this research project is to determine if use of optimized target oxygen     strategy during delivery room resuscitation can reduce oxidative stress in premature     newborns. Objective is to compare oxidative stress markers between preterm neonates     resuscitated in the delivery room using three different target oxygen strategies. OX50 target     oxygen strategy is currently in use and recommended by neonatal resuscitation program. In     this strategy oxygen is adjusted to meet the goal transitional saturations which are     approximated 50th centile saturations observed in healthy term newborns. In OX25 target     oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are     25th percentile transitional saturations observed in healthy term newborns. In OX75 target     oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are     75th percentile transitional saturations observed in healthy term newborns.   "
12986|NCT03115450|"     The purpose of this investigator-initiated study is to compare the use of pupilometer and     ultrasound assessment of optic nerve sheath diameter in predicting the ICP and to see if     there is a value that could be used to indicate elevated ICP with either modality as these     numbers are inconsistent throughout the literature. Patients that have either an external     ventricular drain (EVD) or bolt placed will be enrolled in the study. After the EVD and bolt     are placed the patient will undergo pupilometer examination (standard of care) followed by     ultrasound assessment of the optic nerve sheath diameter (ONSD). The three values will be     recorded. The same patient may have multiple readings performed if there is a change in ICP     either spontaneously or due to intervention.   "
13017|NCT03115047|"     Comparing two treatments for shivering after cesarean delivery for labor dystocia under     epidural anesthesia.   "
12987|NCT03115437|"     The main goal is to investigate the influence of shoe cushioning and body mass on the risk of     running-related injury. This study will allow to determine if shoe cushioning needs to be     adapted to the mass of the runner in order to minimize injury risk. The influence of shoe     cushioning on running technique will also be investigated.      This study consists in a 6-month follow-up period during which leisure-time runners are     required to perform a running activity at least once a week and to upload all their running     as well as other sporting activities onto a secured web-based training calendar named     Training and Injury Prevention Platform for Sports (TIPPS) on a weekly basis. Any injury     sustained during this period should also be uploaded onto the TIPPS system using the injury     questionnaire provided on the website. Finally, the day of the visit to the laboratory (study     start), their running style will be analysed during a 15-minute run on an instrumented     treadmill at the participant's usual running speed. Anthropometric measurements will also     taken.      Before the beginning of the study, the participants will receive a pair of running shoes free     of charge. These shoes will either have a soft or hard sole. Both shoe versions have     cushioning properties that correspond to the range of values from the shoes available on the     market. They will be administered through random allocation. Neither the participants nor the     research team will know which shoe version was provided to the participant, in order to     respect the double-blinded methodology of this study. The participants will be required to     use these shoes for all running sessions, and only for running activities.      Hypotheses:      H1: Running shoes with greater stiffness are associated with a higher injury risk in     leisure-time runners.      H2: High body mass is associated with a higher injury risk in leisure-time runners.      H3: Runners with a high body mass experience a lower injury risk in shoes with greater     stiffness.      H4: A higher step length, a lower step frequency, and higher peak vertical impact forces are     associated with a higher injury risk.      H5: Running shoes with greater stiffness will be associated with higher vertical impact peak     forces and a shorter contact time.      H6: High body mass will be associated with higher peak vertical impact forces, increased     contact time, increased duty factor, and decreased step frequency.   "
12988|NCT03115424|"     Observational studies suggest that bariatric surgery is the most effective intervention for     weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve     Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight     loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly     affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect     feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less     marked. In this study the investigators propose to randomize subjects undergoing SG to     receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and     CV risk factors.   "
12989|NCT03115411|"     Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for     management of benign biliary strictures.   "
12990|NCT03115398|"     By utilizing fitness trackers, this study aims to demonstrate that a simple walking program     improves patients' ability to tolerate curative concurrent chemoradiotherapy without     treatment interruption.   "
12991|NCT03115385|"     This study will recruit 40 obese Hispanic youth (12 - 18 years of age who are greater than or     equal to Tanner stage 4) from hospitals, clinics, and community centers. Participants will be     randomly assigned to 16 weeks of probiotics (3 packets/day of VSL#3) or matched placebo. The     purpose of this study is to demonstrate through a proof-of-concept trial that probiotics have     the potential to alter the gut microbiome and gut hormones.   "
12992|NCT03115372|"     This randomized clinical trial studies how well a lay health worker outreach works in     increasing colorectal cancer screening in Asian Americans. Training community members to     educate participants about colorectal cancer and its prevention may improve colorectal cancer     screening rates in Asian Americans.   "
13047|NCT03114657|"     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the     efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.     Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab     or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be     performed at 105 weeks. The participants who do not enter open-label extension will enter for     a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).   "
12994|NCT03115346|"     This study tests the use of a decision aid for Veterans who are facing a decision about     surgery for their aortic abdominal aneurysms (AAA). The investigators will enroll Veterans     with AAA who are candidates for endovascular or open surgical repair. There are 20 VA medical     centers participating in the trial. Ten sites will be randomly assigned to the intervention     group, and 10 sites will be randomly assigned to the control group. Twelve Veterans will be     enrolled at each site. At sites assigned to the intervention arm, Veterans will receive a     decision aid with information about the two types of surgery for AAA repair, open and     endovascular, and complete a survey about their preferences. Veterans at control sites will     complete the same survey, but will not receive the decision aid. After their surgery,     Veterans will take another survey asking about their satisfaction. The investigators will     compare the results of the survey between Veterans' in the intervention and control groups to     determine the effect of the decision aid on agreement between preference and repair type.   "
12995|NCT03115333|"     This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic     resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for     early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may     help evaluate changes in the blood vessels within the cancer to determine a patient's     response to treatment.   "
12996|NCT03115320|"     The primary aim of this study is to find out if ovulation triggered with hCG provides any     additional benefit in comparison to spontaneous LH surge measured with the home test when     transferring frozen-thawed embryo in a naturally stimulated cycle.   "
12997|NCT03115307|"     This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in     two groups including 121 patients in each group. In the first group, the patients will be     treated with triptoreline (Gonapeptyl®) in their luteal phase. As for the other group, the     patients will undergo the luteal phase without any supportive medication. This study is going     to clarify the role of the gonadotropin agonist (triptoreline, Gonapeptyl®) as a luteal phase     supporter. The benefit of the treatment is measured by the numbers in the live birth and     clinical pregnancy rates.   "
12998|NCT03115294|"     Observational study of patients undergoing open heart surgery. During the procedure video     clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and     ECG recordings.   "
12999|NCT03115281|"     WIN is a prospective, observational multinational post-marketing registry designed to     evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical     practice.   "
13000|NCT03115268|"     The project will investigate the feasibility and acceptability of a remote support group     intervention for people with aphasia, and will investigate the impact of that intervention on     measures of wellbeing, quality of life and communication. The intervention will be delivered     to 32 participants in Eva Park, a virtual island specifically designed for people with     aphasia.   "
13003|NCT03115229|"     The aim of this study is to determine the effect of preventive nursing interventions, which     consist of education / practices including of healthy eating and physical activity and     motivational messages which sent through social media to reduce obesity risk in university     students who in the risk group for obesity.   "
13004|NCT03115216|"     This pilot study aims to primarily assess the rate of complication of anterior vitrectomy for     patients undergoing femtosecond laser-assisted (FLA) cataract extraction and intraocular lens     placement (CEIOL) compared to manual CEIOL, when performed by resident physicians under     direct attending supervision. In this pilot study, the investigators aim to assess what the     incidence of anterior vitrectomy is for each group, in order to better understand the sample     size needed to assess whether there is a difference between these two groups. Secondarily, it     will gather preliminary data on safety and refractive outcomes for patients undergoing these     interventions.   "
13005|NCT03115203|"     The problem posed is the possibility of objectively assessing facial muscle mobility.      Today, in patients with facial paralysis, the assessment of the deficit is carried out using     a subjective scale such as the House Brackman [1] or EMG scale of the facial nerve but does     not distinguish each muscle individually . Objective measurements of skin muscles such as     thickness and volume, in preoperative assessment of a facial paralysis rehabilitation     surgery, would be useful in order to choose the most appropriate surgical technique. Indeed,     too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will     be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap.      Similarly, it would be useful to be able to objectively evaluate the recovery of muscle     function after facial allo-transplantation.      Although electromyography has been developed since the work of Duchenne de Boulogne, little     research has been carried out on the development of noninvasive methods to objectively     characterize in vivo skin muscles (variation, position, orientation, morphometry). The main     morphometric data of the skin muscles come from anatomical dissections.      Imaging of the skin muscles has not been specifically developed. Some studies have been     carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia     gravis, facial paralysis, and labio-alveolo-palatine clefts for example.      The originality of the project is to develop a method allowing to establish a quantitative     correlation between the movements of the face and the muscular changes. This correlation will     be achieved by associating muscular morphological data derived from MRI acquisitions and     cutaneous deformations resulting from clinical examinations. This non-invasive approach     should make it possible to establish objective and reproducible indicators in patients with     facial paralysis sequelae.   "
13013|NCT03115099|"     The aim of this trial is to evaluate the safety of single doses of a study drug known as     LY3325656 that is given orally to healthy participants and participants with type 2 diabetes.     Information about any side effects that may occur will be collected.      It will also investigate how much of the study drug gets into the blood stream, and how long     it takes the body to get rid of it.      The study consists of two parts. Part A will study healthy participants over approximately 12     weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks,     excluding screening. Screening is required within 28 days of the start of the study.   "
13014|NCT03115086|"     This is a prospective, observational, non-interventional patient registry designed to     document long term safety and clinical outcomes for 10 years in patients treated with     Cholbam/Kolbam, including those who have been using Cholbam/Kolbam and those who start     Cholbam/Kolbam treatment at enrollment.   "
37857|NCT02790112|"     This study evaluates the influence of early adiposity rebound, genetic polymorphisms and     GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.   "
13006|NCT03115190|"     Rationale: This study aims to aid the general practitioner (GP) in the diagnostic dilemma of     chest pain patients. Patients with acute coronary syndrome (ACS) should be referred to the     hospital promptly, though referring all patients with chest pain is not feasible, as up to     80% of the patients with chest pain in the primary care do not have ACS.      Objective: The primary objective is to refer patients who contact the out-of-hours GP     cooperation (GPC) with suspicion of ACS more accurately with a hypothesized reduction of 10%     in unnecessary referrals.      Study design: This study is a prospective, observational, prevalence-based cohort study     within the standard care of ACS patients.      Study population: All patients with chest pain, or other complaints suspect of ACS, will be     included in which the GP at the GPC is in need of further diagnostics to come to a decision     of referral. The follow-up will be a registry of all patients with suspected ACS referred to     the emergency department (ED). Patients with typical complaints of ACS, and thus a high     suspicion, will be excluded and referred promptly.      Intervention: Triage nurses working at the GPC will receive specific ACS training. Patients     who arrive at the GPC with non-typical chest pain, will be screened for enrolment within the     study. The GP evaluates patients using the Heart score, this includes electrocardiogram     recording and point of care (POC) troponin testing. With the Heart score the GP can make an     informed decision to refer the patient to the ED.      To evaluate the intervention a registry of all patients referred to the ED with suspected ACS     will be compared to a baseline registry performed from the 1st of September 2015 until the     1st of March 2016. Patients not referred to the ED, will have a (standard) high-sensitivity     troponin and a POC troponin as follow-up at least four hours (up to 24 hours) after first     measurement.      The burden and risks associated with participation, benefit and group relatedness: Patients     enrolled within this study will receive a finger stick blood test and electrocardiogram     recording at the GPC and a finger stick blood test and a venous blood test at least four     hours after first troponin measurement. We may follow-up by telephone if we can not obtain     the required information from medical records. We expect no adverse events and there are no     expected risks associated with this protocol. We expect patients with ACS to be referred more     accurately and more promptly to the ED and thus lowering risks.   "
13007|NCT03115177|"     The purpose of this study is to investigate antibiotic treatment to target bacteria about the     shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder     surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure     of total shoulder arthroplasty as well as other shoulder surgeries. This study is     investigating adding an FDA approved antibiotic that is commonly used for treatment of this     bacteria and many common infections. The investigators will take intraoperative cultures to     look for the presence or absence of specific bacteria. The investigators are conducting this     trial to see if adding another antibiotic to specifically target this common bacteria found     around the shoulder will be effective.   "
13018|NCT03115034|"     The main purpose of this study is to evaluate the effects of melatonin in the regulation of     the vascular injury in patients under carotid endarterectomy through population-based,     randomized, double-blind, placebo-controlled trial.   "
13019|NCT03115021|"     This study aims at comparing the effects of transcranial direct current stimulation and     transcranial pulsed current stimulation on neurophysiological outcomes on patients with     disorders of consciousness. This study also aims to evaluate the effects of these techniques     on patients' level of consciousness.   "
13051|NCT03114605|"     The physical, emotional, economic and social damage of stress in the police corporation     indicates an urgent call for preventive programs to approach stress reduction, burnout     symptoms and promotion of quality of life and well-being.      The aim of the POLICE study is to evaluate the effectiveness of a Mindfulness-based     intervention (MBI), compare to a waiting list (WL), in promoting quality of life and mental     health in police officers.   "
13052|NCT03114592|"     This study is looking to improve the safety of patients with acute kidney injury via     education provided on a mobile tablet. This study will additionally examine if electronic     tools, such as mobile tablets, can help.   "
13008|NCT03115164|"     Astrocytomas / infantile desmoplastic gangliogliomas (DIA / DIG) are rare brain tumors     usually affecting infants. They represent about 0.5% of all pediatric brain tumors. DIA / DIG     occurs mainly in the first 2 years of life, with a sex ratio M / F of 1.7 to 1. From a     histological point of view, DIA / DIG are neuroepithelial tumors. These tumors may have a     purely astrocytic differentiation (DIA) or be composed of tumor cells with astrocytic and     neuronal differentiation (DIG). The desmoplastic component is usually adjacent to the     meninges and is defined by the increase or modification of connective tissues related to the     presence of neoplastic cells with the formation of a collagen-rich extracellular matrix.      Due to their benign biological behavior and favorable clinical course, they are classified in     benign tumors, ie grade I according to the WHO classification. However, all tumors called DIA     / DIG do not behave in a benign manner. Cases of metastatic cerebrospinal and malignant     disorders have been described. It appears that about 40% of DIG cases require additional     medical treatment such as chemotherapy, radiotherapy and / or new surgery, and 15% of infants     and children with GIDD die from the disease. It is possible that what is grouped within the     DIA / DIG is a heterogeneous group of tumors, evolution and prognosis very variable.      The cytogenetic knowledge of DIA / DIG is very limited and is only available on small numbers     of cases. Cytogenetic analyzes of several cases of DIG showed normal karyotypes. More     recently, a CGH-Array study of 3 cases of DIA / DIG did not find any significant chromosomal     gains or losses.      It has been shown, however, that a mutation involving BRAF (BRAF rearrangement or BRAF V600E     mutations) was a recurrent element in low grade gliomas, particularly in pediatric patients.      It is also suggested that deregulation of BRAF activity in some DIA / DIG may indicate the     importance of the MAPK (mitogen-activated protein kinase) pathway in signaling pathways for     DIA / DIG development. However, data on the link between the BRAF gene and DIA / DIG remains     very limited. Thus, further studies are needed to study the other members of the MAPK pathway     in DIA / DIG (eg PI3K / AKT / mTOR). This could provide new therapeutic possibilities     involving targeted therapies specific to the MAPK signaling pathway.      It appears that DIA / DIG does not all behave in a benign manner and some would undergo a     malignant transformation that could be due to chromosomal alterations such as, for example,     TP53, PI3K. In addition, because of the limited number of cases, it would be interesting to     study the characteristics of patients with DIA / DIG in order to study their characteristics     and whether there are clinical, pathological, cytogenetic and / Molecular forms between     benign and malignant forms.   "
13009|NCT03115151|"     Postoperative analgesia following spine surgery is difficult to manage. Current treatment     modalities rely heavily on opioid analgesics with all of the inherent limitations and side     effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple     different drugs and techniques to control pain after surgery), there is no consensus     regarding which components of this multimodal therapy provide optimal analgesia. This     prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion     Surgery at Zale Lipshy University Hospital. The primary objective is to determine the     comparative efficacy of epidural analgesia, as compared with intravenous (IV)     patient-controlled analgesia (PCA), on post-operative analgesia.   "
13010|NCT03115138|"     Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery     followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward:     the more or less complete surgery, the pseudo-progression after radiochemotherapy, the     radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose     problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would     greatly facilitate the follow-up of these patients.      It is now established for many cancers that circulating tumor DNA (cTNA) has the same     molecular abnormalities as those identified in the primary tumor cells. Numerous studies have     shown the prognostic value and diagnosis of the exploration of cDNA.   "
13011|NCT03115125|"     Severe sepsis and septic shock are the most severe forms of sepsis (which associates a     systemic inflammatory response with infection). These are serious pathologies with a     lethality estimated at almost 40% at 28 days (after the onset of sepsis).      After a first pro-inflammatory phase, a second compensatory phase called Compensatory     Anti-Inflammatory Response Syndrome (CARS) takes place quickly. Patients then show signs of     immunosuppression and profound alterations in immune functions. It is during this phase that     the vast majority of deaths occur, far from the onset of the shock, which is related to the     inability of the immune system to eliminate the initial infectious agent and / or a greater     susceptibility Important to develop secondary infections (nosocomial infection, latent virus     reactivation ...).      The CARS phase has been the subject of studies focusing on measuring the plasma concentration     of anti-inflammatory cytokines (such as Interleukin (IL) -10), the percentage of regulatory T     lymphocytes (Treg), Or the percentage of monocytic expression of HLA-DR in septic patients.      The investigator proposes to carry out the first study on a newly described regulatory     lymphocytic subpopulation: regulatory B lymphocytes (Breg) from a quantitative and functional     point of view in severe septic states.   "
13012|NCT03115112|"     The purpose of this study is to investigate the effect of bexagliflozin compared to     sitagliptin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in     subjects with type 2 diabetes mellitus (T2DM).   "
13015|NCT03115073|"     This is a multi-center, randomized, prospective, active-controlled, double-blind,     dose-escalation study comparing dose response of clinical efficacy, safety, local     tolerability of three different doses of ProF-001/Candiplus® (Candiplus® 0.2%, Candiplus®     with 0.3%, Candiplus® with 0.4%) to 1% clotrimazole vaginal cream.      Patients with acute episode of vulvovaginal candidiasis (VVC) will be randomized to receive a     daily dose of either 5 ml (intravaginal) of Candiplus® at three different doses for the first     3 days and 2.5 ml for the remaining 3 days or 5 ml (intravaginal) application of 1%     clotrimazole cream over the first 3 days and 2.5 ml for the remaining 3 days according to the     following scheme (with each application 2 cm of cream will be applied to the vulvar region):      Cohort 1: Candiplus® 0.2% versus clotrimazole mono Cohort 2: Candiplus® 0.3% versus     clotrimazole mono Cohort 3: Candiplus® 0.4% versus clotrimazole mono Randomization into the     cohorts will occur consecutively from the lowest dose to the highest dose, i.e. patients will     be randomized first in cohort 1 and finally in cohort 3.      The proposed study is - after a pilot study to assess critical pharmacokinetic data - the     second study within a clinical trial program with the objective to develop a new combination     therapy for the treatment of vulvovaginal candidiasis.      The new combination consists of two registered drug substances.   "
13016|NCT03115060|"     Fluid management being an important component of surgery becomes more challenging for an     anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable     consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9%     NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia     associated with potassium-containing fluids. Plasmalyte is another fluid which can be used     and probably will lead to better metabolic profile in these group of patients.The primary     objective of this study will be to compare the effects of using normal saline (NS), Ringer     lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during     living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal     function.   "
13020|NCT03115008|"     I plan to investigate the value of video-based feedback in endoscopic training -     specifically, the role of terminal video feedback as compared to usual concurrent feedback on     cold snare polypectomy technique in trainees, using Direct Observation of Polypectomy Skills     (DOPyS) competency score. I have focused the study on the competency of cold snare     polypectomy for subcentimeter polyps. The majority (>75%) of colon polyps are smaller than     one centimeter. Cold snare polypectomy has been shown, and recommended by the American     Society for Gastrointestinal Endoscopy (ASGE), to be an effective removal technique. However,     its widespread use and moreover, its teaching to trainees is lacking. It takes time and     resources to learn and teach endoscopic techniques. Our study will hope to identify a     mechanism through video-based feedback that could help to improve the translation of the     training of polypectomy skills to its actual performance, and to accelerate the learning     curve.   "
13021|NCT03114995|"     Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for     Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.   "
13022|NCT03114982|"     This study evaluates the immunogenicity and safety of three different potencies of NBP608 and     Varivax which are indicated for active immunization for the prevention of varicella. Total of     152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are     enrolled, and each subject is administered with single dose of vaccine which is randomly     assigned.   "
13023|NCT03114969|"     For effective drug delivery using inhalation route, it is important to use the inhalers     correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI,     alone or in combination, in comparison with other DPIs. The study aims to provide clinical     evidence in subjects with COPD that the reduced number of steps required to use the ELLIPTA     DPI could result in fewer errors made by subjects, and therefore a more consistent treatment.     Approximately 450 subjects prescribed with either of RELVAR® ELLIPTA, ANORO® ELLIPTA,     INCRUSE® ELLIPTA, SYMBICORT® TURBUHALER®, SERETIDE® DISKUS®, SPIRIVA® HANDIHALER®, ULTIBRO®     BREEZHALER® or SEEBRI® BREEZHALER will be included in the study and will have 2 clinical     visits. At Visit 1, subjects will take their maintenance DPIs and the critical and overall     errors made by subjects will be assessed. After the assessment, subjects will be instructed     on correct use or informed of their correct use of their DPIs. The total duration of the     study is approximately 6 weeks. ELLIPTA, SERETIDE and DISKUS are registered trademarks of the     GSK group of companies. SYMBICORT and TURBUHALER are registered trademarks of the AstraZeneca     group of companies. SPIRIVA and HANDIHALER are registered trademarks of Boehringer Ingelheim     Pharmaceuticals. ULTIBRO, BREEZHALER and SEEBRI are registered trademarks of the Novartis     group of companies.   "
13045|NCT03114683|"     The study is to evaluate ORR, CR, PR DCR DOR PFS and safety of IBI308 in treatment of     patients with Relaspsed/Refractory Hodgkin's Lymphoma.   "
13046|NCT03114670|"     Patients with acute myeloid leukemia(AML) recurred after the allogeneic hematopoietic stem     cell transplantation (allo-HSCT) have a dismal prognosis.The investigators developed     donor-derived chimeric antigen receptor modified-T cell(CART) to target CD123 for the     treatment of AML. The investigators start the Phase I study aimed to treat recurred     post-transplantation AML patients using donor-derived CAR-T. The purpose of this study is to     assess the safety and effectiveness of anti-CD123 CAR-T cells in patients.   "
13061|NCT03114462|"     The goal of this clinical research study is to find the highest tolerable dose of     stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients     with laryngeal cancer. The safety of this radiation will also be studied.   "
37953|NCT02788864|"     The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine +     Piperaquine (DP) are effective in preventing malaria infection for forest ranger   "
13024|NCT03114956|"     Peri-implantitis represents a major biological complication of implant dentistry with     reported prevalence of up to 47% of implants. The disease is characterized by inflammatory     response to the biofilm inhabiting the implant surface. To treat this inflammatory disease,     surgical and non-surgical therapies have been proposed, all of which entail biofilm removal     through implant surface decontamination. Systematic review of various surface decontamination     protocols has failed to demonstrate superiority of any of the protocols. One possible     explanation is that most studies have examined decontamination of implant surfaces following     experimentally-induced peri-implantitis, where implant surfaces lack the tenacious     mineralized biofilm often found in clinical peri-implantitis and are therefore easily     decontaminated.      The investigators have hypothesized that control of inflammation and repair of pathologically     damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface     decontamination therapy. The aims of this study are to 1) determine the most effective     surface decontamination protocol that can lead to control of peri-implant inflammation and 2)     delineate the microbial and immunological mediators that are associated with the changes in     peri-implant inflammation. The investigators propose to compare conventional implant surface     contamination techniques to a comprehensive mechanical plus chemical protocol. This     randomized controlled clinical trial seeks to enroll 68 participants with at least one     implant diagnosed with moderate to severe peri-implantitis. Pre-op parameters to be assessed     include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal     inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial     sampling, and digital intra-oral peri-apical radiograph. Subjects will be randomly assigned     to one of the four surgical debridement intervention groups: (A) gauzes soaked in sterile     saline and chlorhexidine; (B) Titanium brush; (C) Air power abrasion; (D) comprehensive     surface decontamination, including titanium brush, air powder abrasion and surface etching     with 9.6% hydrofluoric acid gel. At 3-months post-operative, the initial clinical assessment     will be repeated. The clinical examination will be used to analyze the efficacy of each     treatment in controlling peri-implant mucosal inflammation. The ultimate objective of this     research is not only to identify an effective method for control of peri-implant     inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that     can potentially be helpful in future studies as risk factors of this disease.   "
13025|NCT03114943|"     This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax     which are indicated for active immunization for prevention of varicella. Total of 488     subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and     each subject is administered with single dose of vaccine which is randomly assigned.   "
13036|NCT03114800|"     The goal of this work is to develop and test an automated movement detection monitoring tool     that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence     rates. Ten healthy participants will perform video-recorded bed movements while weight     distribution and interface pressures at bony prominences on the pelvis are recorded.   "
13037|NCT03114787|"     Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few     studies deal with this subject, especially in respiratory resuscitation   "
13139|NCT03113448|"     To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain     relief in patients with PDN compared with placebo lotion as a randomized, double- Blind,     crossover, placebo-controlled trial   "
13026|NCT03114930|"     Prior to the HAS recommendations of March 2014, the mother - newborn couple was discharged     from the maternity home at 4 days after delivery by AVB and 5 days after caesarean section.      The stay in maternity allowed a follow-up of the newborn whose weight gain and the occurrence     of a jaundice; And monitoring of the mother whose milky ascent and psychological feelings.      In March 2014, the HAS published new recommendations on maternity leave arrangements for the     mother - newborn couple, the organization of postpartum follow - up for the mother and     pediatric follow - up for the newborn. The HAS then defines so-called optimal conditions     for so-called standard outputs, with 9 criteria to respect respectively for the mother and     the newborn.      If the mother-to-newborn couple respects these so-called optimal conditions and is eligible     according to the respective criteria, the latter leaves at home after 72 hours and before 96     hours for an AVB and after 96 completed hours and Before 120 hours for caesarean delivery.      As no pediatric discharge was done in the afternoons at the maternity hospital of Amiens, an     arbitrary choice was made to allow a standard release to the mother-newborn couple only     if the child was born between 00H00 and 11H59 so that his clinical examination of exit is     carried out at 72 hours of the birth as recommended by the recommendations of the HAS.      These recommendations being recent (2014), no study has studied the impact and consequences     on the triad father / mother-newborn of these exits including the occurrence of possible     complications or events: re-hospitalizations again The early termination of breastfeeding,     and whether the follow-up procedures advocated by the HAS are being followed.   "
13027|NCT03114917|"     This is a randomised controlled trial which investigates the effectiveness of CARMS     (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and     how well CARMS works in practice within the NHS. The trial will compare two groups of people     with psychosis who are using NHS mental health services. One group will carry on with their     usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus     their usual treatment.   "
13028|NCT03114904|"     The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the     incidence is estimated at 32.1%.      Cerebrospatized patients are probably more prone to withdrawal because they require high     doses of sedation.      Moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of     the therapeutic management).   "
13029|NCT03114891|"     This is a Phase I Clinical Trial designed to evaluate novel transcranial magnetic stimulation     (TMS) methods for treating depression/PTSD. TMS is an FDA-approved procedure for     treatment-resistant depression. The use of the stimulation in this current study is     considered experimental. The purpose of this research study is to compare the effects of TMS     at two different brain regions. This information will help the investigators to determine     which treatment strategies provide the greatest clinical benefit to patients. Results of the     study will provide brain and behavior measures for future work, which may be critical to     developing effective disease markers and novel treatments for psychiatric conditions.   "
13030|NCT03114878|"     A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and     EMDR as a treatment for tinnitus.   "
13031|NCT03114865|"     The investigators primary objective is to determine the safety and toxicity of incorporating     blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance     setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia [ALL],     Non-Hodgkin's Lymphoma [NHL]).   "
13032|NCT03114852|"     The REGENT study (Familiar Renal Disease, Epidemiology and Genetics in Niteroi/Rio de     Janeiro) is a epidemiological study that try to identify and clinically describe questions     about genetic renal diseases in a southeast Brazilian population undergoing renal replacement     therapy.   "
13033|NCT03114839|"     Currently, obtaining samples directly from the small bowel is difficult due to the highly     invasive intubation methods used. Research on the effect of dietary probiotics on the gut     microbiota is therefore largely dependent on measurement of the microbial composition in     fecal samples. At best, the measurement in fecal samples reflects microbial composition of     the large intestine. The microbial composition in the small intestine differs substantially     from the composition in feces. In addition, many physiological processes that are modulated     by dietary probiotics, such as immunoregulation, mainly occur in the small intestine.     Therefore, it is vital to study the effects of dietary probiotics on the small intestinal     microbiota, as well. Successful sampling of the small intestine has been demonstrated in     animals and humans, using the IntelliCap® CR system. The main aim of the current study is to     explore and compare the small intestinal microbiota profiles in healthy subjects before and     after consumption of a probiotic drink containing Lactobacillus casei strain Shirota (LcS)     (Yakult®).   "
13034|NCT03114826|"     Renal transplant patients have on average 3-5 times more risk of developing cancer than the     general population. This rate can be increased up to 10 to 15 times in some type of cancer     like kidney cancer. Among the identified risk factors, immunosuppressants and, in particular,     calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers     apart from their depressant effects on the immune system.      Calcineurin inhibitors (CCN) are the basis of immunosuppressive therapy in renal     transplantation. Several mechanisms have been implicated to explain their pro-oncogenic     properties. One related to an increase in VEGF expression seems particularly interesting in     the study of renal cell carcinoma in the transplanted patient. Indeed, the physiopathology of     kidney cancer has clearly been associated with an increase in the production of VEGF.     Furthermore, some polymorphisms of the gene encoding VEGF have already been associated with     the survival of patients with renal carcinoma and the circulating level of VEGF in the     general population. The search for an association between the polymorphisms of the VEGF gene     and renal carcinoma in renal transplant patients could thus identify patients whose risk of     renal cell carcinoma (cRCC) post-transplantation is increased. If the involvement of certain     polymorphisms in the development of cRCC was confirmed in this population, their research     before the introduction of the immunosuppressive treatment would make it possible to direct     the choice of treatment towards molecules without pro-oncogenic property in the Patients such     as mTOR protein inhibitors (sirolimus, everolimus). This research project is therefore in     line with the desire to move towards a more personalized medicine that could be beneficial     for the patient.   "
13035|NCT03114813|"     Aim:      To test if MRI can detect meaningful changes in portal pressure in the liver to assess     whether treatment with beta-blockers has worked.      Liver Disease:      Most people with liver disease do not have symptoms. Over time they develop 'cirrhosis' -     severe liver scarring. In the United Kingdom deaths due to cirrhosis have doubled over the     last decade, because of increasing rates of alcohol consumption and obesity, while heart,     kidney, lung diseases, strokes and cancer fatalities have fallen.      Portal pressure:      Cirrhosis causes increased pressure within the liver and changes in the circulation leading     to the development of varicose veins in the gullet and stomach called 'varices'. Varices     bleed easily, leading to emergency situations that can be life threatening. However, if the     increased pressure within the liver (portal pressure) is detected early, then treatment can     prevent variceal bleeding. The only test we have to predict prognosis and treatment success     in someone with cirrhosis is by measuring the portal pressure.      Measuring portal pressure:      Currently the only existing test to measure portal pressure is to pass a pressure sensor     through a vein in the neck, down into the liver. This is called the hepatic venous pressure     gradient (HVPG) measurement. The HVPG measurement is disliked by patients because it is an     invasive procedure. It is also expensive and not widely available. Hence, patients with     cirrhosis need to have regular camera tests (endoscopies) to look for varices.      How can you treat varices?      Two options;        1. With tablets to lower the pressure (beta-blockers)        2. Endoscopy treatment (banding)      Both have advantages and disadvantages;        -  Beta-blockers only lower the portal pressure in about half of those that take them, with          some evidence they may also have a protective effect against infections from the bowel          by increasing the speed of bowel motion        -  Treating the varices with endoscopy requires several endoscopies and can lead to          life-threatening bleeding.      Most patients are therefore given beta-blockers and monitored closely to see if they work.      Why does it matter?      Beta-blockers can cause side effects (e.g. fainting) that are unpleasant enough to make up to     one third of patients stop taking them. Beta-blockers only reduce the portal pressure in half     of patients. The remaining patients are exposed to potential side effects and possible harm     in those with the most advanced liver disease. These patients may still have a     life-threatening bleed as the varices have not been adequately treated. There is a desperate     need to discover whether the portal pressure changes with treatment (such as with     beta-blockers) without invasive tests across the NHS.      Proposed study:      Researchers in Nottingham have shown MRI can be used as an accurate marker of portal pressure     with just one scan. To be useful to patients, doctors and researchers, this study will     investigate whether MRI can detect meaningful changes in portal pressure after treatment with     beta-blockers. This study has been designed with patient and public involvement (PPI)     integrated throughout. A focus group shaped the study design and committed to collaborate in     developing patient materials, recruitment, retention and dissemination.      All patients who have HVPG will be given information about the study.      Study Visit 1        -  One hour MRI scan        -  Endoscopy to identify varices             -  If varices are present the patient will be started on beta-blockers and invited to               visit 2             -  If there are no varices, patients will return to regular follow up with the liver               team      Study Visit 2 (after one week)        -  Assess side effects, blood pressure and pulse        -  Increase dose of beta-blocker as appropriate      Study Visit 3 (after 4-12 weeks)        -  One hour MRI scan        -  Repeat HVPG measurement      Treatment success is determined by the second HVPG measurement. If beta-blockers are working     they will be continued. If not, the patient will have treatment with endoscopy. This     represents the ideal pathway which is more personalised than current standard care.   "
13038|NCT03114774|"     The bispectral index (BIS) monitoring is an EEG-based method that uses electroencephalogram     analysis and a complex algorithm to generate a numerical scoring 0-100 (0 flat line EEG, 100,     wide awake) BIS monitoring allows noninvasive, objective measurement of level of     consciousness of a sedated patient. A limited number of studies have used measurements of BIS     monitoring to assist endoscopic sedation.There are studies using BIS monitoring to make     sedation easy for ERCP procedures. However, the studies evaluating use of BIS for     gastrointestinal endoscopy show inconsistent results.      The objective of this study is to evaluate effects of sedation on the dosage of propofol by     monitoring with BIS values, hemodynamics, recovery parameters, respiratory functions and     endoscopist satisfaction based on the hypothesis that the investigators would reduce the risk     for respiratory depression using minimal doses of propofol in order to achieve the desired     level of sedation with BIS monitoring.   "
13039|NCT03114761|"     Introduction: Morbid obesity, defined as a body mass index (BMI) of over 40 kg/m2, is     globally an imminent health threat. Conservative therapies do often not yield the desired     result. Bariatric surgery includes several interventions that are performed on patients with     morbid obesity, like gastric bypass surgery. The number of bariatric surgeries annually is     estimated to be around 500,000 worldwide; about half of these are gastric bypass surgeries.     In the Netherlands, the most common performed bariatric intervention is the Roux-en-Y gastric     bypass (RYGB). An important long-term complication of this surgery is internal herniation, a     condition in which a part of the GI tract is herniated through an opening in the mesentery     made during RYGB surgery. Incidence of internal herniation is 1-5%. Conventional abdominal CT     examination is often not conclusive about the presence of internal herniation. When internal     herniation is clinically highly suspected after abdominal CT examination (but not necessarily     confirmed), the patient is subjected to diagnostic laparoscopic surgery. Unfortunately, a     negative abdominal CT scan does not exclude internal herniation in all patients. This pleads     for the development or exploitation of alternative techniques that might aid in the diagnosis     of complications after RYGB surgery. Since the anatomy of GI tract is altered when internal     herniation is present, visualizing the mesenteric vasculature may aid in the diagnosis of     this complication after RYGB surgery. This study aims to confirm the feasibility and     superiority of diagnosing internal herniation using CT examination of the mesenteric arteries     over conventional CT examination.      Objectives: The primary objective is to determine whether abdominal arterial CT angiography     is a feasible technique for diagnosing internal herniation after RYGB surgery. Secondary, it     is examined whether arterial angiography of the mesentery is superior over conventional CT     examination with oral and IV contrast in the venous phase.      Study design: This study will be a prospective pilot study, in which the outcomes of both the     conventional CT examination and abdominal angiogram are compared to the outcome of diagnostic     laparoscopy as gold standard.      Study population: Patients will be included who underwent laparoscopic RYGB surgery at least     half a year earlier and have persisting abdominal pain. They should be highly suspected for     internal herniation by their doctor, based on several characteristics.      Main study parameters/endpoints: Primary study endpoints are the assessments of the arterial     abdominal angiogram and mesenteric arterial mapping in relation to the outcome of the     diagnostic laparoscopic surgery in 12 subjects.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: In this pilot study, study subjects will receive an additional effective     radiation dose of about 10 mSv. On average, an acute dose of 10 mSv leads to an additional     risk of cancer of about 1 in 1750 (~1 in 2000 for males, ~1 in 1500 for females) for a     50-year old subject, based on the linear no threshold model. However, when the mesenteric     artery mapping proves to be feasible and superior, many unnecessary diagnostic laparoscopic     surgeries will be prevented (along with their complications and risks).   "
13040|NCT03114748|"     This protocol aims to develop the use of behavioral and electroencephalographic measures     during cognitive tasks in patients treated with deep brain stimulation during the stimulation     parameters adjustments. The main clinical goal of this protocol is to find behavioral and or     electroencephalographic markers to evaluates the right targeting of stimulation electrodes.     On the more fundamental point of view, the study of those data can be used to understand     better the action mechanisms of deep brain stimulation.   "
13041|NCT03114735|"     The objective of this study was to detect whether preoperative anxiety and pain sensitivity     had effects on the consumption of anesthetics, time to achieve desired level of sedation,     patient and endoscopist satisfaction, and postoperative recovery time and pain in deep     sedation.   "
13042|NCT03114722|"     This study is a prospective, randomized, non-blinded study. 1 group will be assigned the     standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This     is consistent with the standard procedure of PICC care in the investigators' centre. The     second group will be assigned the intervention with use of 4% citrate lock (Dirinco     Citra-Lock 4%) in between each catheter use.   "
13043|NCT03114709|"     Physical inactivity has reached pandemic proportions and is associated with increased     morbidity, mortality, and healthcare costs. Of particular concern is that most middle to     older age adults fall far short of recommendations for health enhancing physical activities.     This research takes a novel approach to tackling this problem by combining mindfulness with     behavioral strategies in a unique 'Mindful Movement' program offered through YMCA community     facilities.   "
13044|NCT03114696|"     The objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with     respect to sleep-promoting effects in subjects with sleep complaints.   "
13048|NCT03114644|"     Observations of the early interactions between the infant and his parents highlighted the     existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby     relationship and the emotional and cognitive development of the baby. In this study, the     investigator proposes to focus on premature births (before 37 years) because prematurity     disrupts the synchronization of these mother-baby communication. For several years, reading     of stories and nursery rhymes has been used by the liaison child psychiatry team in the     neonatal medicine and pediatric intensive care unit of the University Hospital of Amiens, as     a therapeutic mediation tool allowing And support for parent-child interactions. Thus, it is     desirable to explore the impact of reading stories and rhymes on mother-baby synchronies. The     study is innovative because it simultaneously explores several fields: physiological,     neuroendocrine, cognitive and psychic. A pilot study carried out in 2013 showed the     feasibility of this exploration in the three protagonists of the interaction: mother, preterm     baby and reader.   "
13049|NCT03114631|"     The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed     dendritic cell Immunotherapy for the patients with pancreatic cancer   "
13050|NCT03114618|"     Venous thromboembolism (VTE) is a common disease in cancer patients and one of the major     causes of cancer-associated mortality. Risk for developing VTE increases when cancer patients     are receiving chemotherapy. Current risk scores for predicting cancer-associated VTE in     ambulatory patients had low/moderate discrimination and clinical sensitivity. These models     use clinical and biochemical parameters of the patient.      In the development of VTE genetics play a relevant role. The product Thrombo inCode (TiC)     assess VTE risk prediction by using a combination of a genetic risk score (GRS) and clinical     parameters from the patient. The investigators hypothesized that the GRS included in TiC     combined with clinical parameter some of them associated with cancer could be better     predicted by TiC than by current risk scores (Khorana score).   "
13817|NCT03104582|"     To investigate the biliary drainage-related cholangitis and other complications of     percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT)     compared with endoscopic biliary drainage (EBD).   "
13053|NCT03114579|"     Continuous perioperative cardiac output (DC) and blood pressure (PA) monitoring contributes     to hemodynamic stability and ensures adequate perfusion pressure, resulting in a reduction in     morbidity and mortality and length of hospital stay.      The monitors usually used in perioperative are either semi-invasive and difficult for     calibration (oesophageal Doppler) or invasive (arterial catheter).      The Nexfin HD allows these two measurements and it is completely non-invasive, remains to     validate its use in peroperative.   "
13054|NCT03114566|"     The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer     donors in order to create Good Manufacturing Practice grade banks of virus-specific and     tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for     therapeutic use.   "
13055|NCT03114553|"     The purpose of this study is to better understand the linkages between family health history     (FHH) and genomics in a Singaporean population. Secondly this study will evaluate the     facilitators and barriers to implementation of a family history collection and risk     assessment tool within a Singaporean population.   "
13056|NCT03114540|"     A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral     dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or     severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic     function.   "
13057|NCT03114527|"     This is a two center, 2 arm, Phase II study evaluating the combination of Ribociclib and     Everolimus in patients with advanced DDL and LMS who have had at least 1 prior systemic     therapy. Patients will be enrolled by sarcoma histology into DDL (Arm A) and LMS (Arm B). The     purpose of this study is to determine the anti-tumor activity of this doublet therapy in     these patient cohorts. Ribociclib will be administered orally at 300 mg/day 3 weeks on/1 week     off. Everolimus will be administered 2.5 mg orally on a continuous 28 day cycle. Clinical and     laboratory assessments will be made on day 1, d15 of cycle 1 and 2, and day 1 of each     subsequent cycle. Tumor response will be assessed by RECIST 1.1 at (CT or MRI) at week 8, 16,     24 and every 12 weeks thereafter. Study drug administration will continue until disease     progression, unacceptable toxicity or withdrawal of consent. Patients will be followed until     death or are lost to follow-up for analysis of secondary endpoints.      There will be a 1 step registration process for dedifferentiated liposarcoma patients while     patients with leiomyosarcoma will require a 2 step registration process. For step 1 of     registration, patients must meet all the eligibility criteria necessary for step 1. For step     2 registration, patients must meet the inclusion criteria necessary for step 2 to be enrolled     into the study.   "
13058|NCT03114514|"     10 ml of blood from each patient will be drawn. This blood specimen will be centrifuged in a     specific way to get 1 ml of platelet rich plasma (PRP). PRP will be injected into the the     skin under the eyes. The treatment course consists of three sessions of PRP injections with     one-month intervals between the sessions.   "
13059|NCT03114501|"     Objectives:      Primary Aim:      Examine the feasibility of a dyadic yoga program in 40 Head and Neck Cancer (HNC) patients     undergoing radiotherapy (RT) and their family caregivers.      Secondary Aims:      1. Establish the initial efficacy of the yoga program in patients and their caregivers     regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive     symptoms, and overall QOL) and objective performance outcomes (i.e, sit to stand test and     grip strength).   "
13062|NCT03114449|"     Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative     pain and analgesic requirement in comparison with sham AA in patients after elective knee     arthroplasty      Design Prospective randomized controlled blinded clinical trial      Participants:        -  Patients < 80 und > 50 years old        -  scheduled for knee arthroplasty under general anesthesia with < 120 minutes duration        -  Without previous opioid medication        -  Able to give informed consent      Outcome measures        -  Postoperative analgesic requirement        -  Incidence of side effects        -  Physiological parameters   "
13063|NCT03114436|"     This is a 1-year national prospective cohort study that observes the medical management of     consented deceased organ donors at hospitals across Canada with a high volume of deceased     donation.   "
13064|NCT03114423|"     The purpose of this clinical study is to examine the established, therapeutic EMDR     intervention for patients with substance use disorders (SUD). The EMDR method is an     integrative and structured therapeutic method which assumes that memories which have been     dysfunctionally stored can lead to harmful behavior. The EMDR protocol used for this clinical     trials has been specifically developed for patients with SUD - the results should be compared     with traditional therapy. For the assessment of the EMDR treatment some questionnaires are     given at several times.   "
13065|NCT03114410|"     This study uses a cluster-level randomized controlled design to evaluate the efficacy of     Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex,     pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy     prevention program for adolescents covering a broad range of topics related to sexual health     and youth development, including healthy relationships, communication, gender, consent,     reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life     planning. Re:MIX also aims to connect students and peer educators with community resources     and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades     8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of peer     educators (who are young parents) will deliver the information with professional health     educators using non-traditional approaches, such as game-based tools, technology, and     storytelling. Youth receive roughly nine hours and 10 minutes of group sessions during the     school day over one semester (55 minutes per week for 10 weeks). Participants will be 8th,     9th, and 10th graders attending three public charter schools in Travis County, Texas.     Comparison classes will either receive an alternative program that focuses on health,     nutrition, and fitness, or business as usual. This study is being conducted as a Rigorous     Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S.     Department of Health and Human Services' Office of Adolescent Health.   "
13159|NCT03113175|"     The aim of the study Collabri Flex is to:        -  Develop a Danish model for collaborative care for patients with anxiety in general          practice, based on past experience gained in the Collabri Project.        -  Examine the impact of this model compared with liaison-consultation for people with          anxiety in a randomized controlled design from selected endpoints.   "
13066|NCT03114397|"     In this multicentric double-blind sham controlled study, we plan to assess the effects of 20     sessions of tDCS on long-term behavioral recovery in patients with disorders of     consciousness. Neurophysiological outcomes (EEG) will also be collected.      This research will 1) determine whether long-term behavioral recovery can be promoted with     tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome     (i.e., EEG) in severely brain injured patients. We will compare the effects of active and     sham tDCS on behavioral assessments and qEEG in patients with severe brain injury and its     potential application in rehabilitation.   "
13067|NCT03114384|"     Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface     electromyogram, measurements of airway flows and pressures as well as a continuous     ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger     modulation will generate a number of asynchronies between the subject and the respirator.      These records will help to assess the agreement between the detection of asynchronies using     electromyography of the respiratory muscles (technique of reference) and the diaphragmatic     echography. We will also compare the respective performance of two techniques of     diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of     Ultrasound technique of at least 90% will be interpreted as a satisfactory index of     concordance.   "
13068|NCT03114371|"     Positive results in preclinical and clinical studies in adults and infants with Prader-Willi     syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The     objective of this study is to document effects of oxytocin intranasal administrations on     behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.   "
13069|NCT03114358|"     Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with     late de-escalation without compromised clinical outcomes   "
13070|NCT03114345|"     Paraplegic patients have defective wound healing for sore below the level of spinal lesion.     Defect of vascularization of the healing zone certainly participate to this effect.     Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g.     the pressure between the patient body and the surface he/she is lying on) to assess the     correlation between mechanical stress in term of pressure applied over time and tissue     oxygenation which represent micro-vascular function. The aim of this clinical trial is to     correlate the variations of pressure intensities and changes in micro-vascularization. The     measure are recorded when paraplegic patient came into the hospital for pressure ulcer     related surgery. The patient is laying on his/her mattress on top of a flexible pressure     mapping device. The micro-vascularization parameters are measured at the area displaying the     peak pressure a few minutes after the beginning of the pressure interface recording and one     hour later at the same area. The data generated during this monocentric study will help to     achieve a better understanding of the relation between pressure and micro-vascularization. In     the mid term, it will provide a better and more patient adapted pressure ulcer prevention.   "
13071|NCT03114332|"     A randomized controlled trial that aimed at studying the values (if any) of subcutaneous     drains use in lean women during Cesarean section.   "
13072|NCT03114319|"     The purpose of this first in human (FIH) trial is to characterize the safety and tolerability     of the SHP2 inhibitor TNO155 and identify a recommended dose for future studies in adult     patients with advanced solid tumors in selected indications.   "
13073|NCT03114306|"     Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced     recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic     element in this context. This RCT evaluates two analgetic regimens for patients undergoing     primary total knee-replacement to assess impact on postoperative recovery.   "
13074|NCT03114293|"     Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to     use feedback mechanism in an app-based intervention program to increase physical activity in     Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been     explored as effective in the last years. In addition, smartphone-based mobility assessment     and intervention might be a promising approach in other MS types and for real-life mobility     assessment in observational and interventional trials. The aim is to investigate the impact     of a smartphone based information and feedback program on physical activity in a 3 months,     randomised waiting-group controlled trial of 40 progressive MS patients.   "
13075|NCT03114280|"     Non-randomized phase II, open-labeled clinical study of docetaxel (T), cisplatin (P), 5     Fluorouracil (F) and pembrolizumab every 21 days followed by radiotherapy (RT) combined with     carboplatin in untreated unresectable locally-advanced Head and Neck Squamous Cell Carcinoma     (HNSCC).      The TPF and pembrolizumab combination will be called TP2F.   "
13076|NCT03114267|"     Autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic     mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and     mortality in young women and autoimmune thyroid diseases are the most common.      Viral infections are the main environmental factors suspected of triggering autoimmune     diseases. Several viruses are certainly involved, all of which are possibly capable of     triggering an autoimmune response. However, the precise identification of the viruses     involved remains to be established.      It has been shown for the first time by the 2005 PHRC that enteroviral RNA is present in     perioperative specimens of thyroid tissue. However, this case-control study did not show any     difference between the thyroid group and the group other thyroid pathologies It has been     recently published that Parvovirus is possibly involved in thyroiditis: the parvoviral genome     is present in the thyroid tissue of Hashimoto thyroiditis operated and more precisely is     present within the thyrocytes itself.   "
13077|NCT03114254|"     An evaluation of the activity of cabazitaxel chemotherapy in relapsed cancer of the penis.     Safety and tolerability will be monitored and survival will be assessed. It is hypothesised     that cabazitaxel is useful in increasing progression free survival in relapsed penile cancer.   "
13078|NCT03114241|"     Long-term evaluation of a coaching program which helps patients with severe COPD to increase     their daily step count, in addition to usual care.   "
13160|NCT03113162|"     This is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity     immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in     patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months,     6 months and 12 months post-transplantation.   "
13079|NCT03114228|"     The purpose of this study is to gather and evaluate additional safety data on the combination     of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine     kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard     induction and consolidation chemotherapy and are without satisfactory treatment alternatives     prior to the commercial availability* and reimbursement of midostaurin during the regulatory     approval process   "
13080|NCT03114215|"     This is a 6-month double blind randomized 2:1 placebo-controlled study with two arms     (placebo, biotin 300 mg/day). The study will be followed by a 6-month extension phase during     which all patients will receive biotin 300 mg/day.   "
13081|NCT03114202|"     This study investigates the effects of nutritional counseling versus standard nutritional     care on nutritional status and quality of life in patients with head and neck cancer     submitted to radiotherapy.Half participants will receive intensive nutritional counseling     while the other half will receive standard care.   "
13082|NCT03114189|"     The purpose of this study is to ascertain whether warm footbathes are effective on sleep     disturbances in women before climacteric.   "
13083|NCT03114176|"     Overweight divers face a challenging activity such as immersions, starting from a higher     levels of circulating cytokines and oxidative stress. Ketogenic Diet (KD) is described as     effective in weight loss, in countering inflammation and oxidative stress, and used in the     control of drug-refractory seizures.      The aim of our pilot study was to evaluate if a ketosis state induced by a specific dietary     regime, may have a protective effect on oxidative stress damages and inflammatory status,     that accompanies both overweight and diving activities.      Blood and urine samples from six overweight divers were obtained a) before (CTRL) and after a     dive breathing Enriched Air Nitrox and performing light underwater exercise (NTRX), b) after     a dive (same conditions) performed after 7 days of KD (K-NTRX). We measured urinary     8-isoprostane and 8-OH-2-deoxyguanosine evaluating lipids peroxidation and DNA oxidative     damages. Plasmatic IL-1beta, IL-6 and TNF-alpha levels were measured to investigate the     inflammatory status.   "
13084|NCT03114163|"     This is an observational study in adult patients in Germany diagnosed with SCCHN progressing     on or after platinum-based therapy, who start a new systemic therapy with nivolumab for the     first time, and are treated within the market authorization approval. Patients are to be     enrolled into the study no earlier than the decision to initiate treatment with nivolumab and     no later than the first dose of nivolumab treatment.   "
13085|NCT03114150|"     Given the accelerating growth of older adults worldwide and the decline in cognitive function     with aging, therapeutics that remediate age-related cognitive decline are needed more than     ever. The proposed research seeks to better understand and enhance the detection of exercise     effects on hippocampal network function and learning and memory, which decline with aging and     Alzheimer's. Success would lead to new ways to detect benefits of exercise on cognitive aging     and would lead to mechanistic insight on how such plasticity is possible while also informing     prevention strategies.   "
13086|NCT03114137|"     The CADRE study is a multinational observational cohort of patients with sickle-cell disease     (SCD) in five west and central sub-Saharan African countries. The aim of this project is to     describe the incidence and assess the predictive factors of SCD-related micro- and     macro-vascular complications in sub-Saharan Africa.   "
13087|NCT03114124|"     The aim of our study is to investigate the comparative efficacy of high fidelity multi     electrode ablation catheters vs the standard bipolar configuration in success of AV nodal     ablation This study will provide insights on the use of new technology where application may     increase efficacy, promote patient and physician safety and decrease costs.   "
13111|NCT03113812|"     This first time study in humans was designed to assess tolerability and safety of repeated     subcutaneous injections of ABvac40, an active immunization against the C-terminal end of     Abeta1-40.   "
38710|NCT02778919|"     The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship     of KLH-2109 compared to placebo in Japanese patients with endometriosis.   "
13089|NCT03114098|"     Psychotropic drugs are frequently used in children and adolescents in France with a     prescription rate of 2.5%. Antipsychotics (PA) and antidepressants (AD), each concern 0.3% of     the pediatric population (Kovess et al., 2015). Despite appropriate pharmacological     treatment, some patients are drug-resistant and have persisting symptoms and ineffective     psychotropic treatments. These children and adolescents are generally exposed to many     psychotropic molecules and often to poly-therapy.      Most psychotropic treatments, especially AP and AD, are metabolised at the hepatic level by     cytochrome P450 and in particular by CYP2D6. Duplication / multiplication of the CYP2D6 gene     induces too rapid metabolism of drugs.      Demonstration of a CYP2D6 abnormality has a direct impact on the management of the patient     and on the clinical decisions of the clinician. Thus, knowledge of individual metabolism will     decrease the failure of treatment, improve quality of life and therapeutic compliance.   "
13090|NCT03114085|"     It is an open,randomized,controlled study, and the purpose of this study is to observe and     evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of     patients with advanced hepatocellular carcinoma.   "
13091|NCT03114072|"     Sleep disturbances are common in pregnancy, and the incidence increases during the third     trimester. Light and specially the blue wavelengths of light, is affecting sleep and the     circadian rhythm. The main aim of this randomized controlled study is to investigate the     effect of Blue-blocking glasses (BB-glasses) used in the evening and night on sleep and mood     in pregnant women in the third trimester. The outcome measures assess sleep variables,     alertness, melatonin level, sleepiness (subjectively), mood and symptoms of anxiety and     depression. In addition we want to measure the pregnancy related sleep problems, alcohol     intake, physical activity and perceives stress in the study population, and the association     with daily/nightly light exposure.   "
13092|NCT03114059|"     This study evaluates the results of all clinically relevant findings of glaucoma diagnostics     5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent     procedure. The comparison of Preoperative and long term postoperative results is the aim of     this study to evaluate this young procedure of Glaucoma surgery   "
13818|NCT03104569|"     The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic     contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde     cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.   "
13093|NCT03114046|"     The purpose of this single-subject, concurrent mixed methods study is to investigate the     relationship between the effect of the CIMT protocol on gait and mobility and participants`     and caregivers` expectations and perceptions regarding the treatment. The goal of the     quantitative strand is to assess changes in quality of movement and functional use of the     paretic lower limb after the treatment and investigate the participants` expectations in     regards the intervention using the Participant Opinion Survey (POS). The qualitative strand     (participant interviews) will determine perspectives of caregiver and participant     perspectives regarding protocol acceptability. Both quantitative and qualitative data will be     collected and analyzed concurrently, through triangulation and complementarity rationales;     both data will be equally prioritized.   "
13094|NCT03114033|"     The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide     (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher     than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks.     It will be the largest trial ever conducted in heart attack patients in the intensive care     unit. This therapy is cost free and, if shown to be effective, will improve thousands of     lives, transform clinical practice, and yield major savings.   "
13095|NCT03114020|"     The purpose of the study is to evaluate the safety and efficacy of administering repeated     doses of Hyaluronic Acid Inhalation Solution to subjects with Emphysema that have     Alpha-1-Antitrypsin deficiency   "
13096|NCT03114007|"     Mental health problems affect 10-20% of children and adolescents worldwide, with half of     affected youth experiencing problems by the age of 14. Despite the early onset of mental     health problems, evidence-based prevention and early intervention programs remain scarce. If     left untreated, early-onset mental health problems can progress to become severe or chronic     conditions, and incur significant medical and societal costs.      The current project proposes an integrated screening and intervention model that was     developed involving active youth, family and community engagement. This project, known as     Inter-Venture, focuses on reducing barriers to youth mental health care and promoting early     screening and intervention by fostering collaboration between school and community-based     services providers. The Inter-Venture project is being conducted in the Montreal area     (Canada), and consists of three intervention modalities. Namely, 1) systematic school-based     screening and personality-targeted interventions for students most at risk of mental health     problems and substance misuse (the Preventure program); 2) a parent program designed to     strengthen parenting skills and to improve the management of child behavior problems     (Cope/EQUIPE program); 3) integrated services provided by a multidisciplinary team of     professionals (referred to as Inter-Action) for youth with significant symptoms of mental     health problems, substance misuse and/or psychosocial difficulties. The intervention model     involves knowledge transfer to boost capacity-building and improve the provision and     sustainability of evidence-based interventions in community settings.      The primary goal of the Inter-Venture trial is to assess the potential effect of the     school-based targeted interventions and collaborative care in the prevention, early detection     and reduction of mental health problems, substance misuse and psychosocial difficulties among     young people. The secondary goal is to assess the effect of interventions on school     performance and whether the interventions can protect cognitive functions that may be     negatively affected by early-onset substance use and mental health problems, and promote     cognitive development through the prevention of these difficulties.   "
13097|NCT03113994|"     Rationale: After having a spinal cord injury (SCI), people develop changes in their body     composition that influences their long-term health. Individuals with paralysis after SCI will     have large declines in their bone density ant increases in fat mass which increases their     risk of fracture and heart disease. Therapies to prevent SCI-related changes in body     composition and their health effects are needed. Drugs known as statins used often to     reduce high cholesterol, may help to reduce bone loss and inflammation.      Hypothesis: Among adults with SCI for a long time, treatment with a drug named Rosuvastatin     or a sugar pill, with supplements (coenzyme Q10, calcium and vitamin D), for twelve months     can decrease their endocrine metabolic disease risk by increasing bone density and reducing     inflammation.      Study Design: A clinical trial will be conducted in Toronto, Ontario and Miami, Florida.     Subjects will get statin therapy or placebo (sugar pill) by chance. Study subjects and     research staff will not know whether they are taking the study drug or a sugar pill until     after the study      Subjects: Fifty-four adults (age 18-60 years) with a long-term SCI and no movement below     their level of injury.      Treatment: Subjects will be prescribed Rosuvastatin 10 mg daily or a sugar pill. In addition,     all subjects will receive 100 mg of Co-Q10 daily, calcium carbonate 1250 mg and, vitamin D     2,000 IU once a day.      Data Collected: Subjects' bone density will be collected at the start and end of the study.     Change in bone density between the two groups will be compared to see if one is better. Blood     samples will be collected quarterly to make sure subjects are safe and do not develop     problems with their liver or muscles and to measure the effects of the study drugs on     inflammation throughout the body.      Clinical Implications: Statins may be safe and effective therapy for adults living with SCI     who are at increased risk of endocrine metabolic disease as they age.   "
13112|NCT03113799|"     To evaluate the performance characteristics of the Smart External Drain (SED) compared with     standard EVD drains in the hospital setting, specifically:        -  Number, type and duration of staff interactions.        -  Regulating and controlling ICP and CSF drainage.        -  Maintaining system control with patient movement.   "
24173|NCT02969252|"     The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin     SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male     and female healthy subjects.   "
13098|NCT03113981|"     The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition,     with high morbidity, sometimes fatal, requiring costly treatment.      The treatment is difficult because biofilm forms very early after the bacterial     contamination of the prosthesis.      Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling     protein response to allow osseous-integration of the prosthesis.      A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This     bioactive polymer allows to substantially reduce bacterial adhesion, biocompatibility,     bio-integration in preclinical studies. This first clinical study aims to compare the     osseous-integration of this prosthesis to the same prothesis with no grafting.      No previous clinical trial   "
13099|NCT03113968|"     The goal of the study is to conduct a comparative randomized trial of electroconvulsive     therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real     world setting with patient reported outcomes as primary and secondary outcome measures.   "
13100|NCT03113955|"     A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in     the Treatment of Localized Hepatocellular Carcinoma   "
13101|NCT03113942|"     This is a single centre open label phase II trial to determine the antitumor efficacy of the     oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated     high grade squamous intra-epithelial lesions (HSIL) in patients with and without human     immunodeficiency virus (HIV) infection.   "
13207|NCT03112551|"     the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced     from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short     duration of drug exposure is suitable for low resource setting where there is little tools or     busy staff for monitoring drug toxicity.   "
13290|NCT03110432|"     This is a prospective German registry for patients with dyslipidemia with very high     cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations     for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are     treated by office-based cardiologists or in lipid ambulances.   "
13102|NCT03113929|"     The current goal in the treatment of Alcoholic Liver Disease (ALD) is to manage     ALD-associated complications as there are no disease-specific therapies. Identifying     disease-specific therapies to slow ALD progression is critical to improving the outcomes in     these patients. Despite preclinical treatment studies in animal models that have shown     promise, clinical trials in ALD patients have been limited by the absence of sensitive,     quantitative methods for identifying severity and monitoring progression of liver disease.     The rates of progression of liver disease in ALD are variable and difficult to predict, which     makes assessments of therapies difficult. Clinical measures of hepatic or biliary disease     (e.g., bilirubin, transaminases) may be normal, only mildly elevated and/or stable despite     ongoing organ damage. Liver biopsies are diagnostic, but are invasive and are of limited     value for longitudinal monitoring. Currently clinical imaging, including standard volumetric     imaging (MRI and ultrasonography) and hepatic fibrosis assessment (e.g. Fibroscan) are also     of limited utility in fully staging disease severity and monitoring progression in ALD. The     absence of clinically available methods for accurately determining the severity and     progression of liver disease progression in ALD has limited implementation of clinical trials     using novel therapeutic agents. Development of non-invasive imaging biomarkers to assess     rates of liver progression will overcome this barrier and allow for such studies to be     undertaken. This study intends to perform a one-time MRI on patients with ALD to search for     these biomarkers that can improve the diagnosis and treatment of ALD patients.   "
13103|NCT03113916|"     This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability     of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes     or T2D. The intervention will be integrated into patient care at a Federally Qualified Health     Center serving over 30,000 low-income patients, and will be delivered by trained clinic     staff, with minimal support from research staff. After the effectiveness clinical trial, two     cohorts of clinic patients will receive the intervention in a sustainability test.   "
13104|NCT03113903|"     The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in     Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple     questions. These questions simulate daily life situations likely to induce pain of various     intensities. The internal validity of the tool had been demonstrated both for the original     version in German, and then for its English version. The external validity had also been     demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers     (German version), and to patients before surgery (English version). A French validation of     the questionnaire is needed, in order to integrate it in pain research programs in     French-speaking countries.   "
13105|NCT03113890|"     This is a three month naturalistic prospective, randomized, open label study of     pharmacogenetic testing and clinical outcomes in inpatients across diagnoses, including     Treatment Resistant Depression (TRD) with or without Post-Traumatic Stress Disorder (PTSD),     recruiting from the Short Term Unit at McLean Hospital.      Specifically, the investigators will enroll 200 inpatient subjects over 2 years who will     donate saliva/undergo a cheek swab to collect DNA for the Genecept assay. For 100 patients in     the assay-guided group, treating Clinicians will receive the Genecept report prior to patient     discharge and use it to guide psychoeducation and medication management. For the additional     100 inpatients, treating clinicians will not receive the report during the patient's     inpatient stay (treatment as usual. Clinicians will receive the assay report for patients in     the treatment-as-usual group at the 3-month followup period. Thus this group will serve as     the control group for the outcomes related to Genecept-guided decision making.   "
13106|NCT03113877|"     Based on survey data, individuals with Cornelia de Lange Syndrome (CdLS) often experience     symptoms of autonomic dysfunction however there are no reported studies in which these     patients have had objective testing of the autonomic nervous system. This is a pilot study in     which patients with CdLS will undergo the standard clinical testing for autonomic dysfunction     with a autonomic reflex screen and thermoregulatory sweat test.   "
13107|NCT03113864|"     Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and     inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of     interest is middle-aged men and women who have low levels of carotenoids in their eyes.   "
13108|NCT03113851|"     The purpose of this study is to determine whether radiation combined with recombined human     granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe and effective for patients     with metastatic non-small cell lung cancer.   "
13109|NCT03113838|"     This is a prospective registry study to surveil early liver injuries caused by Yangxue     Shengfa Capsule (YXSF Capsule) through a non-intervention observational way. And attempt to     establish a predictive model to screen susceptibilities to YXSF Capsule.   "
13110|NCT03113825|"     Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic     breast cancer undergoing surgery.   "
13113|NCT03113786|"     The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a     tissue barrier when used as an annular patch in discectomy patients with low back & leg pain     when compared to traditional discectomy patient outcomes. This will be a 120 patient,     prospective randomized study model over a 5 year post-operative period.   "
13114|NCT03113773|"     The mainstay for treatment for acute coronary syndrome (ACS) focusses on re-establishing and     maintaining the patency of vessels following coronary plaque disruption, through the use of     anti-platelets and anticoagulants. Despite advances in management ACS still carries a high     risk of morbidity and mortality, thus future management is likely to target other pathways.      Recent studies indicate that CD4+ T cells, and more specifically Treg cells, are important     for the control of post-ischemic immune responses and the promotion of myocardial healing.     The investigators therefore hypothesise that expansion of Treg cells in patients with ACS     dampens the activation of the immune response and promotes both plaque and myocardial     healing. The investigators hypothesise that this can be achieved through subcutaneous     administration of low doses of interleukin-2 (IL-2). IL-2 supplementation appears to be an     attractive therapeutic option playing a key role in Treg cell development, expansion,     survival and suppressive function.   "
13291|NCT03110419|"     This study aim to evaluate the effects of 16 weeks of multicomponent training on postural     control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear     and linear measurements.   "
13115|NCT03113760|"     This is a Phase 3 study to assess the safety and efficacy of Tadekinig alfa in patients with     monogenic, interleukin-18 (IL 18) driven autoinflammation due to Nucleotide-binding     oligomerization domain, leucine-rich repeat and caspase recruiting domain (CARD domain)     containing 4 (NLRC4) - Macrophage activation syndrome (MAS) mutation (NLRC4-MAS mutation) or     X-linked inhibitor of apoptosis (XIAP) deficiency. Because of the likelihood for pathogenic     IL-18 in certain monogenic diseases, patients known to harbor deleterious mutations in     NLRC4-MAS or XIAP and who have a history of ongoing inflammation will be enrolled if they     have ferritin ≥ 500 ng/mL or persistent C reactive protein (CRP) elevation > 2 times the     upper limit of normal (ULN) and the patients should have a Modified Autoinflammatory Disease     Activity Index (mAIDAI) ≥ 4.   "
13116|NCT03113747|"     The purpose of this study is to evaluate safety and efficacy of tissue engineered construct     based on allogeneic cultured adipose-derived multipotent mesenchymal stromal cells     (ALLO-ADSCs) and platelet-poor plasma fibrin hydrogel to treat patients with 2-B and 3-     degree burn wounds   "
13117|NCT03113734|"     This study develops the construction and validation of a reliable functional screening score     in LCA ruptures in the immediate post-traumatic period.      This score, realizable in an emergency, would be an early warning signal requiring an     emergency consultation with an orthopedic surgeon. It would be a tool for screening acute LCA     ruptures at a time when ligament testing maneuvers are too painful to be contributory to the     diagnosis. It would avoid a premature return to dangerous activity for the knee with a     rupture of the LCA.      The other impact would be economical since it would avoid the realization of unnecessary MRI.      On the other hand, it will allow patients with LCA rupture to have faster access to MRI. The     hypothesis of the study is that a validated functional score would make it possible to sort     the patients in the emergencies and to prescribe the MRI only in the cases of effective     rupture of the LCA.   "
13118|NCT03113721|"     The purpose of this prospective, non-interventional, multi-centre clinical study is to assess     the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence,     or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with     suspected infection following emergency department admission.   "
13119|NCT03113708|"     High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB)     and this may increase postoperative bleeding. The aim of this study is to evaluate the effect     of heparin dose calculated according to lean body weight on intraoperative and postoperative     bleeding.   "
13120|NCT03113695|"     The purpose of the study is to investigate whether combination of obinutuzumab, lenalidomide,     and high dose methylprednisolone in the treatment of Richter's Syndrome. The study will     evaluate whether this regimen can reduce the amount of cancerous cells in your body. All of     these agents are approved by the FDA Obinutuzumab is a protein molecule manufactured from a     single cell population, has been approved by the Food and Drug Administration (FDA) for the     treatment of CLL of SLL. Lenalidomide is for the treatment of patients with other blood     cancers. Methylprednisolone is a type of steroid, and it is used in a wide variety of medical     conditions. These agents and the combination of these agents are not approved for the     treatment of Richter's Syndrome and are considered experimental.   "
13121|NCT03113682|"     The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10     individuals ages 10 and older who have rumination disorder   "
13122|NCT03113669|"     The primary aim of this study is to determine how inhibitory neurobiological and     neurocognitive processes relate to binge eating treatment outcome.   "
13123|NCT03113656|"     Infants with neonatal abstinence syndrome (NAS) who are cared for in a Neonatal Intensive     Care Unit (NICU) often display symptoms including hyperactivity, irritability, jitteriness,     poor feeding, and poor sleep patterns. The recommended first line of treatment to relieve     these symptoms involves nonpharmacological interventions. The purpose of the current pilot     study is to provide preliminary data to assist in the design of a larger scale study to     examine one nonpharmacological intervention, weighted blankets. The pilot study will assess     the feasibility of a cross-over randomized controlled design to study the impact of a     weighted blanket on infants' symptoms of NAS.      The aims of the study are:      Aim1: To determine the feasibility of recruiting patients for a study evaluating the use of     weighted blankets in the care of infants with NAS Aim 2: To determine the feasibility and     safety of the study procedures Aim 3: To examine whether there is clinical benefit to using     weighted blankets for the treatment of symptoms in infants with NAS.      After informed consent is obtained, infants will be randomized to have either a weighted     blanket or a non-weighted blanket placed on them first. A cross-over design will be used so     all infants will experience both the non-weighted and weighted blankets. Thirty minutes     before each feeding, baseline vital signs and Finnegan score will be obtained. Then, a     blanket (weighted or non-weighted) will be placed on the infant for 30 minutes. Infants will     be directly monitored and on heart rate/respiratory rate monitors while the blanket is     applied. Vital signs and Finnegan scores will be obtained at the end of 30 minutes of blanket     placement, infants will be fed, and vital signs and Finnegan scores will be obtained again 30     minutes after the blanket was removed. Descriptive statistics will be used to determine the     enrollment rate and feasibility of the protocol. Nonparametric statistics will be used to     compare total Finnegan scores for infants with the weighted blanket applied compared to     infants with a non-weighted blanket applied. Changes in Finnegan scores will be examined to     estimate an effect size to use in a power analysis for a future larger effectiveness study.   "
13124|NCT03113643|"     This research study is studying a drug as a possible treatment for diagnosis of AML and     high-risk MDS.      The interventions involved in this study are:        -  SL-401        -  Azacitidine   "
13148|NCT03113318|"     To study whether or not total mediastinal lymph node dissection in conjunction with pulmonary     metastasectomy from colorectal cancer is associated with improved survival compared to     pulmonary metastasectomy only.   "
13125|NCT03113630|"     Thirty individuals with ALS (18 men and 12 women, mean age 59 years, range 44-74 years), and     30 healthy controls matched for age and gender, participated. Individuals with ALS and from     the control group were randomly divided into three groups, each using a different     communication device systems (Kinect®, Leap Motion Controller® or touchscreen) to perform two     task phases (acquisition and retention). Performance was then explored in a third phase     (transfer) by switching devices (two transfers); so that, all groups had contact with all     communication interfaces.   "
13126|NCT03113617|"     This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor     (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed     tomography (CT) works in detecting regional nodal and distant metastases in patients with     intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller     tumors than the standard of care CT or magnetic resonance imaging scan.   "
13228|NCT03112278|"     Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to     traditional onlays and complete coverage crowns for the treatment of severe erosive lesions.     Therefore, the purpose of this study is to determine whether ceramic and composite resin     ultrathin occlusal veneers (0.6 - 1.0 mm thick) are effective in the rehabilitation of     patients affected by moderate and severe dental erosion.   "
13127|NCT03113604|"     Primary liver cancer or hepatocellular carcinoma (HCC) is the 7th most common cancer in     humans; 9th in women (figures from the Association for Research against Cancer ARC). This     cancer is a major public health problem on a global scale. Patients, whose diagnosis is often     late, are at advanced stages of the pathology, even those who benefit from locoregional     treatments have a poor prognosis and suffer from a lack of curative therapeutic strategies.     CHC is highly refractory to cytotoxic chemotherapy and so far the response rates to     conventional systemic chemotherapy has provided a clinical benefit where survival was     prolonged by more than 25% in patients with advanced CHC. Further efforts are needed to     effectively manage HCC. Knowledge of the mechanisms regulating proliferation and inhibiting     the sensitivity of transformed cells to apoptosis is the key to the development of more     effective therapeutic strategies.      Several new therapies, called targeted therapies, are tested in clinical trials. Currently,     the most effective molecular agent for targeting the Raf pathway is sorafenib capable of also     inhibiting tyrosine kinases of VEGFR and PDGFR. Sorafenib, a multikinase inhibitor, decreases     the proliferation of tumor cells in vitro that inhibit the activity of targets present in     tumor cells (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and tumor vascularization VEGFR-2,     VEGFR-3, and PDGFR-beta). Despite the real benefit of this treatment, its efficacy (three     months of overall survival) and its indication remain limited to Child-Pugh A, WHO 0-2     patients in whom curative treatment is contraindicated. In addition, several patients have     resistance to Sorafenib and thus find themselves in therapeutic failure, thus limiting the     therapeutic choice for these patients.      Resistance to treatment with Sorafenib limits the therapeutic choice. The mechanisms     responsible for this resistance remain to be elucidated. Drug resistance proteins, MDR     Multi-Drug Resistance, is a family of molecules whose expression increases in the cancer cell     and ensures the repression of chemotherapy molecules outside the target cancer cell. This     family includes the proteins ABCG2, MDR and MRP1. Our in vitro studies show that treatment of     CHC Huh-7 cells with Sorafenib (10 mM) induces the specific expression of the transcripts of     the MRP-1 protein without any effect on the expression of the ABCG2 and MDR protein. In     addition, sorafenib has an effect on the expression of hepatocyte SLAMF3 receptor     transcripts, a receptor recently identified in hepatocyte tissue. Indeed, it has been shown     that the expression of SLAMF3 is lowered in the cancerous tissue compared to the healthy     tissue and that the reintroduction of a strong expression in the cancer cell inhibits its     proliferation by inhibiting the MAPK Erk pathway, Cancer cells to apoptosis and inhibits the     uptake of tumor masses in the Nude mouse (I. Marcq, et al., 2013).   "
13128|NCT03113591|"     Osteo introducer system is the instruments used in minimal invasive THA. This study will     compare the minimal invasive THA using the osteo introducer system and THA using common     instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of     THA surgery.   "
13129|NCT03113578|"     This is an observational registry study collecting data on the clinical performance of the     study device (DiLumen™ ) for its intended use. The primary objective is to evaluate     functional outcomes of the DiLumen device in humans. The secondary objective is to evaluate     safety characteristics of the DiLumen device.   "
13130|NCT03113565|"     After cardiac surgery, patients' follow-up after discharge is a major public health issue.     Since the main complications occur mostly during the first extra-hospital month, a follow-up     period becomes necessary as the average duration of hospitalization tends to decrease. The     resumption of normal physical activity is rarely transmitted and when complications arise,     the healthcare team is most often informed late.      An electronic wristband is worn by the patient during the day, between the day of discharge     from the hospital (D0) and the end of the second extra-hospital month (D60). The data     recorded by the wristband include : bracelet ID, date, time, number of steps per day, and     heart rate averaged by 5 minutes.      The primary objective of the study is to measure the resumption of physical activity after     elective cardiac surgery. This objective will be quantified by the number of daily footsteps.      A secondary objectives is to determine perioperative predictors of the physical resumption.   "
13131|NCT03113552|"     Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects     older than 75 years. They are the second leading cause of valvulopathy in Europe. The most     common etiology is the associated valvular prolapse. Mitral surgery remains the reference     treatment for symptomatic MI. The success of this procedure depends on the mitral valve     geometry and the location of the prolapse. The site of the prolapse, whether monovalvular,     localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities     and probably the long-term results of the plasty.   "
13132|NCT03113539|"     We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without     contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.   "
13133|NCT03113526|"     This is a single-blinded randomized controlled trial to compare the outcomes of early closed     suction drain removal versus output volume-based drain removal after selective lateral neck     dissections (SLND). The main hypothesis of the study is that the early drain removal of     closed suction drains on the first postoperative day is safe compared to the current practice     of output volume-based drain removal when output is less than 30ml/24hr or 15ml/12hr. This     study will also evaluate the hypotheses that output volume-based drain removal of surgical     drains increases inpatient length of stay and decreases the average patient satisfaction     score on the measurement of quality of recovery (QoR-40).   "
13134|NCT03113513|"     To date no study has determined prospectively which technique is superior to prevent     recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical     need. The aim of the study is to determine objective anatomical recurrent prolapse after     Sacrospinous Ligament Fixation (SLF) vs McCall.   "
13135|NCT03113500|"     This phase II trial studies the side effects and how well brentuximab vedotin and combination     chemotherapy work in treating patients with CD30-positive peripheral T-cell lymphoma.     Monoclonal antibodies, such as brentuximab vedotin may interfere with the ability of cancer     cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin,     etoposide, and prednisone work in different ways to stop the growth of cancer cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving brentuximab vedotin and combination chemotherapy may work better in treating patients     with CD30-positive peripheral T-cell lymphoma.   "
13136|NCT03113487|"     This phase II trial studies how well modified vaccinia virus ankara vaccine expressing p53     (p53MVA) and pembrolizumab work in treating patients with ovarian, primary peritoneal, or     fallopian tube cancer that has come back. Vaccines made from a gene-modified virus may help     the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such     as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving     p53MVA and pembrolizumab together may work better in treating patients with ovarian, primary     peritoneal, or fallopian tube cancer.   "
13137|NCT03113474|"     Study into the endocannabinoid response to consuming a palatable versus a neutral food.   "
13138|NCT03113461|"     The purpose of this project is to determine whether obstructive sleep apnea (OSA) treatment     with positive airway pressure therapy (CPAP) can delay the progression of cognitive     impairment in patients with amnestic Mild Cognitive Impairment (MCI) as measured by cognitive     testing, and brain magnetic resonance imaging (MRI) scans. Study participants will be     assessed at baseline, six-month (cognitive tests only) and one-year follow-up.   "
13140|NCT03113435|"     This study compares the actual standard of care with a new protocol to guide hemodynamic     optimization during major abdominal surgery, which is more tailored on patient real needs.     During general anesthesia metabolic needs of the body are markedly reduced and increase in CO     may not be necessary. In addition, excessive fluid administration has been related to worse     post-operative outcomes. We divide patients into three groups: the standard treatment group,     the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2     as marker of tissue ability to increase their oxygen consumption in response to increased O2     delivery, and based on this index the administration of fluid. The principal aim is to     optimize functional hemodynamics in order to reduce the fluid balance at the end of the     surgery.   "
13141|NCT03113422|"     Patients with high tumor burden, low grade follicular lymphoma that has never been treated,     will receive venetoclax in combination with obinutuzumab and bendamustine.      Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2     (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with     follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause     cancer cells to die.      The purpose of this study is to see whether adding venetoclax to obinutuzumab and     bendamustine improves the response (the tumor shrinks or disappears) in patients with     follicular lymphoma.   "
13142|NCT03113409|"     The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient     study of methods to facilitate induction and stabilization onto XR-NTX. There will be three     different methods of XR-NTX induction using increasing doses of oral naltrexone and     buprenophine.   "
13143|NCT03113396|"     Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are     randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high     resolution impedance manometry measurement, were they receive a solid meal, and recordings     continue for another hour. Thereafter, they will receive the alternative treatment, after     which they will undergo a second high resolution impedance manometry measurement. Patients     are asked to fill out questionnaires during the entire study period.   "
13144|NCT03113370|"     Almost 12% of women report smoking during pregnancy. Smoking during pregnancy is associated     with adverse fetal outcomes and up to 35-75% of women quit smoking during their pregnancy.     Clinical trials of tobacco cessation medications have reported safety concerns along with     limited efficacy. Subsequently, these medications are not generally recommended in pregnancy     and most women who stop smoking do so unassisted. Not surprisingly, the rates of smoking     relapse in the post-partum period are up to 67%. To date, clinical trials of behavior     interventions in the post-partum period have been largely null. Pharmacotherapy has not been     studied as a means of preventing relapse in smokers who quit without the use of medications.     Additionally, these medications are excreted in breast milk, which limits there use for     lactating women. Thus alternative, safe, and effective strategies to prevent smoking relapse     in high-risk, former smokers during the post-partum period are needed.      n-3 long-chain polyunsaturated fatty acids (LCPUFA) have anti-inflammatory properties and     appear effective as adjuvant therapy for depression. In animal models, n-3 LCPUFA     deficiencies can result in hypofunctioning of the dopamine mesocorticolimbic pathways which     are related to reward and dependence. Nicotine results in an elevation of dopamine in the     nucleus accumbens which is associated with the pleasurable sensations related to nicotine     use. It has been hypothesized that correcting the hypofunctioning dopaminergic system through     n-3 LCPUFA supplementation might reduce nicotine cravings. Taken together, these studies     suggest that supplemental n-3 LCPUFA might be useful in preventing smoking relapse.      The investigators' hypothesis is that post-partum former smokers randomized to n-3 LCPUFA     supplementation will be less likely to relapse and have less nicotine cravings compared to     women allocated to placebo. To test this hypothesis they will conduct a 12-week, randomized,     double-blind, placebo controlled study of 4 grams/day n-3 LCPUFA supplementation versus     placebo. Participants will be enrolled prior to hospital discharge. The primary outcomes of     the trial will be time to smoking relapse and change in self-reported nicotine cravings. The     secondary outcome will be point prevalence abstinence at 6- and 12-weeks. compliance will be     monitored by measuring red blood cell phospholipid fatty acid content and verify smoking     cessation through end-expired CO and cotinine.   "
13145|NCT03113357|"     Cervicogenic headache (CeH) is a secondary and often unilateral that is known by referring     pain from soft or hard cervical structures to occipital, temporal, frontal and sometimes     pre-orbital regions. There is higher prevalence of cervical muscle tightness, assessed     clinically in CeH patients and anatomically there are some fascial connections between     sub-occipital muscles with vertebra of C2 and Dura-mater.Therefore fascial restriction in     this region can limit the normal movement of muscles between fascial plates in different     directions in sub-occipital region. The purpose of current study was to compare the effect of     MFR Technique in the upper cervical region with common (Exs) on pain intensity, frequency,     duration and Pressure Pain Threshold (PPT) of upper cervical joints in subjects with CeH.   "
13146|NCT03113344|"     This study is based on the hypothesis that the pharmacokinetics of antibiotics in neonates     are different from other children and adults. We aim to study the population pharmacokinetics     of neonates receiving the antibiotics for treatment of infectious diseases. In this study, we     will detect drug concentration in plasma by using residual blood samples of blood gas     analysis and employ computers for constructing population pharmacokinetic models. In     addition, we also want to correlate use of antibiotics with treatment effectiveness and     incidence of adverse effects in neonates. This novel knowledge will allow better and more     rational approaches to the treatment of infectious diseases in newborns. It will also set the     foundation for further studies to improve antibiotic therapies for neonates.   "
13147|NCT03113331|"     The 3D Cohort Study (Design, Develop, Discover) was established to help bridge knowledge gaps     about the links between various adverse exposures during pregnancy with birth outcomes and     later health outcomes in children.   "
13180|NCT03112902|"     Loss of slow wave sleep (SWS) is common in mild cognitive impairment (MCI) and Alzheimer's     disease, and is thought to worsen thinking, memory and brain degeneration. Initial studies     suggest that correction of sleep deterioration may slow the progression of brain damage in     mild cognitive impairment, and might be able to stop the development of Alzheimer's disease.     Transcranial alternating current stimulation (tACS) uses electrodes to deliver very small     amounts of electricity through the brain, with direct effects on brain cell function.     Transcranial electric stimulation has been demonstrated to enhance slow wave sleep and to     improve memory when applied during sleep in healthy adults. The purpose of this research is     to investigate tACS to modulate sleep, thinking/memory, mood, and quality of life among     normal healthy adults, older adults, as well as individuals with MCI.   "
13229|NCT03112265|"     The study will compare the impact of Child STEPs versus usual school-based therapy on neural     and companion behavioral measures of self-regulation.   "
13230|NCT03112252|"     App-based study of allergy patients under medication in the pollen season to determine the     effect of allergic rhinitis on the quality of life.   "
13149|NCT03113305|"     The Roux-en-Y Gastric Bypass (RYGB) procedure is known to be one of the most successful     treatments for morbid obesity and Type 2 diabetes mellitus, and has been shown to decrease     appetite, energy intake, body weight and glycemia both in the short and long term. A number     of reports hypothesise that these changes may be driven, at least in part, by positive shifts     in food preferences following surgery. However, findings are drawn from self-reported dietary     intakes which are beset with measurement bias, thus precluding definite conclusions. The One     Anastomosis Gastric Bypass (OAGB), or mini-gastric bypass, is another variation on the RYGB     with one surgical connection (anastomoses) rather than two. Initial data has shown similar,     or even slightly higher, weight loss and better resolution of diabetes post-surgery than the     traditional RYGB, however as the technique was first reported in 2001 more long-term data is     needed.      The current work aims to directly observe food intake to test the hypothesis that after     gastric bypass (traditional RYGB and OAGB) food intake changes in a manner which leads to     beneficial outcomes on body weight when compared to weight stable control participants.     Patients (n=32; n=16 traditional RYGB, n=16 OAGB) with a planned gastric bypass procedure     will be recruited from Phoenix Health (Ireland and England) and Letterkenny University     Hospital (Ireland), alongside control participants (n=16) with no planned weight loss. All     subjects will attend the Human Intervention Studies Unit (HISU), Ulster University on four     occasions (1-month pre-surgery and 3, 12 and 24 months post-surgery, with controls being     time-matched). Study visits will be fully residential involving two overnight stays within     the facility during which participants' 24-hour food intake will be covertly measured     (7am-11pm Day 2 and breakfast Day 3) and the following procedures undertaken; basal metabolic     rate, body composition, bone health, assessment of liking/wanting high fat foods (Visit 1, 2     & 4 only) and post-meal gut hormone responses. On each study visit participants will have ad     lib access to a range of foods of varying macronutrient composition and which are compatible     with their stated food preferences (assessed prior to the start of the study). Changes in all     ingestive behaviours will be evaluated over time as compared to the control participants and     between groups ((traditional RYGB vs OAGB).   "
13150|NCT03113292|"     The aim will be to compare the effects of a Pilates intervention program with a prescription     of home exercises in individuals with chronic nonspecific low back pain. A second objective     will be to assess the cost of interventions, associated with effects on outcomes. This is a     randomized controlled clinical trial, characterized by the application of therapeutic     exercises, in two modalities: Pilates Method and Home Prescription of Exercises. Participants     will be sequentially enrolled and will be randomly allocated into two groups: 1) Pilates:     which will be submitted to Mat Pilates sessions, 2x / week, for 6 weeks; 2) Home Exercise: 2     sessions of exercise supervised by a physiotherapist and, after, all participants will     receive a booklet with the prescription of home therapeutic exercises, to be performed in the     period of 6 weeks (2x/week) and monitored in a diary. Participants will be evaluated in three     different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention period     (6 weeks); And 3) After two months of follow-up. Primary outcomes will be pain (measured by     VAS), perception of recovery (likert scale of 6-points), functionality (measured by the     Quebec Questionnaire - QDS) and kinesiophobia (measured by the Tampa Scale of Kinesiophobia).     Secondary outcomes will be the postural balance and the quality of life. An economic     evaluation will be carried out, from the economic perspective of the society, with a survey     of direct and indirect costs, associated to the effects of the interventions. Data analysis     will be performed through SPSS software version 22.0. The data normality assumptions will be     evaluated using the Shapiro Wilk test. If the test confirms the assumptions, a mixed ANOVA     with repeated measures will be used, based on the outcomes (functionality, pain, postural     balance, quality of life, perception of recovery and kinesiophobia) and independent variables     (Pilates and Home Exercises), for the comparisons between pre-intervention, post-intervention     and follow-up. Pilates is expected to have better effects than the home exercise prescription     group, associated with the outcomes of interest. In addition, the hypothesis is that the     Pilates costs will exceed the costs from the home-based exercise prescriptions; however, the     analysis of cost-benefit will demonstrate positive results in favor of the home-exercises.   "
13151|NCT03113279|"     Two independent, but interrelated conditions that have a growing impact on healthy life     expectancy and health care costs in developed nations are the age related loss of muscle mass     (sarcopenia) and obesity. Sarcopenia affects approximately one third of adults over 60 years     of age and more than 50% of those over 80 years, which is of concern when one considers that     the most rapidly expanding population demographic in the UK is adults >80 years of age.      Skeletal muscle is important in regulating blood glucose and insulin sensitivity. Thus,     sarcopenia may play a role in exacerbating insulin resistance and progression toward Type II     diabetes (T2D). Indeed, the highest incidence of T2D in the UK has been noted to occur in     adults >65 years. Obesity is a major risk factor for chronic diseases including T2D and     cardiovascular disease. Progression towards obesity is associated with a concomitant decrease     in muscle mass, producing an unfavorable ratio of fat to muscle. Thus, obesity in old age may     exacerbate the progression of sarcopenia.      For the proposed study the investigators will conduct preliminary laboratory tests to     characterize body composition, insulin sensitivity, systemic inflammation, aerobic capacity     and muscle protein metabolism (in the fasted and fed state) in healthy older and obese older     adults for comparison against healthy young individuals.   "
13152|NCT03113266|"     This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody     JS001, as a monotherapy in patients with locally advanced or metastatic bladder urothelial     carcinoma who have failed in routine systemic treatment.   "
13153|NCT03113253|"     Excision and grafting in burn patients can lead to severe blood loss. A preliminary study     conducted in our burn unit showed that the total median blood loss was 1412 mL (1).     Transfused patients had a total median blood loss of 2468 mL and an average number of 4     packed red blood cells (PRBC) administered.      Among the various methods that help limit blood loss, tranexamic acid, which has been proved     useful in traumatology and surgery, has not been sufficiently studied in burn patients. A     preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid     (2).      Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and     reduces the use of blood products.   "
13154|NCT03113240|"     Glutamine-induced recovery in intestinal barrier function by reducing bacterial translocation     was demonstrated in previous studies. In this trial, intensive care unit patients with     enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 10 days     and the effects of the intervention on intestinal permeability will be assessed.   "
13155|NCT03113227|"     Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment     of their cervices will be done before actual induction of labor. First, ultrasound will be     done to assess the angle and the length of the cervix. Then vaginal examination will be done     to assess the characteristics of cervix. Analysis will be done to identify the best predictor     of successful induction of labour.   "
13156|NCT03113214|"     The goal of this study is to find the maximum tolerable dose of radiation that can be     delivered with concurrent chemotherapy (carboplatin & paclitaxel) in patients with esophageal     cancer.   "
13157|NCT03113201|"     The aim of the study Collabri Flex is to:        -  Develop a Danish model for collaborative care for patients with depression in general          practice, based on past experience gained in the Collabri Project.        -  Examine the impact of this model compared with liaison-consultation for people with          depression in a randomized controlled design from selected endpoints.   "
13158|NCT03113188|"     This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination     administered once every 21 days to patients with advanced solid tumors.   "
13161|NCT03113149|"     Individuals with painful knee osteoarthritis (OA) experience restricted physical function.     Few previous studies have investigated comprehensive sets of constructs and tests to     investigate physical function in these patients. Most single studies of knee OA patients show     limited scope for explaining physical function in the perspective of WHO's International     Classification of Functioning, Disability and Health (ICF) 3 levels: Body functions (the     bodily level), Activities (individual level), and Participation (societal level). On the     bodily level there is limited case-control knowledge on muscle strength beyond the knee and     endurance-strength in general. On the activity level, there is similar limitation of     biomechanical bodily features in stair climbing. On the participation level the situation is     similar for objective performance. Measures are needed that inter-relate all three levels of     ICF. These should also include well discriminating tests e.g. knee strength, walking, and     activities of daily life (ADL), as well as both objective and subjective measures.      The purpose of this study is to explore mechanisms that can explain physical function in     patients with knee OA in primary care. The study's main and primary goal is to quantify which     baseline factors and change scores are the strongest predictors of a positive treatment     outcome in terms of patients' global perceived change after physiotherapy. Secondary research     question is: which factors are the strongest predictors of a positive outcome of     physiotherapy in knee OA, in terms of pain intensity, patient specific functional scale, and     function in daily living?   "
13162|NCT03113136|"     The overall aim of the proposed study is to evaluate the effect of switching from     conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and     continued use, as well as biomarkers of toxicant exposure and effects.   "
13163|NCT03113123|"     Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada®     for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high     risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and     women, heterosexual men and women, sex workers, migrants) in combination with overall     prevention services (communautary-based or educational counselling; addiction, social and     psychological care; condoms and lubricating gel; clean injection equipment; sexually     transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B     virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV     infection as soon as possible after diagnosis using an antiretroviral combination recommended     by the French Guidelines on HIV treatment).      The individual benefit being already demonstrated in clinical trials, the aim is to     demonstrate the public health impact of the interventional HIV prevention strategy by     reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV     infections among MSM/transgender in the Ile-de-France area after a 3-year period.   "
13164|NCT03113110|"     RELEVANCE:      Up to 50% of patients without previously known disorders of glucose metabolism develop     posttransplantation diabetes mellitus (PTDM) after renal transplantation, which is associated     with cardiovascular events. Although PTDM is triggered by immunosuppressive agents     (calcineurin inhibitors, glucocorticoids), there is consensus against switching patients from     potent tacrolimus to the less diabetogenic cyclosporin. Full-blown PTDM must therefore be     treated aggressively. Empagliflozin inhibits sodium-glucose cotransporter 2 in the proximal     tubule of the kidney and dramatically reduced cardiovascular risk in type 2 diabetics in a     recent randomized trial. Especially in diabetics with impaired renal function, empagliflozin     was safe, well tolerated, and effective against hyperglycemia and against high blood     pressure. Data on SGLT2 inhibition after transplantation are completely lacking. Therefore,     the potential antidiabetic of choice is currently withheld from the vulnerable PTDM     population.      METHODS, STUDY DESIGN:      Prospective, single-center, non-inferiority study. Inclusion criteria: PTDM (antidiabetic     therapy ≥6 months, based on prior 2-h BG ≥200 mg/dL, fasting BG ≥125 mg/dL (2 times) or HbA1c     ≥6.5%); stable renal allograft function >6 months; eGFR ≥30 mL/min/1.73m2. Most important     exclusion criteria: type 1 and 2 diabetes; insulin demand >40 IU/day; HbA1c >8.5%. After     study inclusion, patients will record 4 weeks of 4-times daily BG measurements before     undergoing an OGTT, lab work and urine analysis (including ketones, urinary culture).     Empagliflozin (10 mg) will be started and insulin discontinued within 3 days. Patients will     be asked to perform urinary dipstick tests at home (i.e. ketones), and to continue recording     BG. Study visits at 2 and 4 weeks (second OGTT + lab work (as above)). If control over     hyperglycemia is insufficient, insulin therapy will be added back, otherwise study patients     remain on empagliflozin monotherapy for 1 year. Statistics will include the paired t-test.   "
13165|NCT03113097|"     Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into     2 groups:        -  group I: women who had only good-quality embryo transfer.        -  group II: women who had both good-quality and poor-quality embryo transfer.      primary outcome was ongoing clinical pregnancy rate   "
13166|NCT03113084|"     The purpose of this phase I study is to know the pharmacodynamic profile in humans of the     sodium heparin of porcine origin of the company União Química, building from the     pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of     heparin directly in biological samples. In addition, the toxicity of the product will be     evaluated in healthy male participants.   "
13167|NCT03113071|"     The primary hypothesis is that digoxin can be safely added to decitabine and will increase     the response rates in medically unfit patients with newly diagnosed AML/MDS or those with     relapsed/refractory AML/MDS. Furthermore, it is hypothesized that the addition of digoxin to     decitabine will result in distinct epigenetic alterations in AML/MDS patients.   "
13168|NCT03113058|"     To evaluate the safety and anti-HBV efficacy of γδT cells.   "
13169|NCT03113045|"     The study will determine the 90% effective seated time after intrathecal injection of     hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.   "
13224|NCT03112330|"     The goal of the suggested research is to develop a treatment option using platelet rich     plasma injection for regeneration of atropic nasal mucosa.      Specific aims of the suggested research is to (1) access the effect of platelet rich plasma     in the patients with atropic rhinitis . Moreover, we will (2) compare the conservative     treatments including saline nasal irrigation or saline nasal spray.   "
13204|NCT03112590|"     This purpose of this study is to evaluate the safety and to find the optimal dose in     participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who     are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab.     This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab     and pertuzumab, including its effect on this type of cancer.      Interferon-gamma is a biologically manufactured protein that is similar to a protein the body     makes naturally. In the body, interferon gamma is produced by immune cells and helps to     prevent serious infections.   "
13170|NCT03113032|"     Total knee replacement (TKR) is the treatment of choice for patients suffering from long     standing severe pain, functional limitation and instability caused by osteoarthritis (OA) of     the knee joint's surfaces. Long standing arthritic joint surfaces, more often lead to pain     and swelling and other physical factors that may contribute to knee joint instability. This     instability causes a feeling of 'unsteadiness' whilst walking and may also contribute to     falls. In view of the latter, it is important for this issue of 'unsteadiness' to be     addressed. TKR helps to remove the cause of pain and swelling, but exercises are crucial to     counteract the joint' instability and any feeling of 'unsteadiness' before and after surgery.     However, research hasn't yet identified the optimum approach for delivering exercises that     will help in patients' rehabilitation. Current studies have tried to incorporate     rehabilitation programmes to improve this issue, but required a delivery of 6-8 weeks of     exercises which has resulted in a logistical burden in view of the long duration. We have     scientifically developed a new programme of exercise for the muscles of the knee that can be     delivered during a single week prior to surgery. The pre-surgery exercise-programme (P-SEC),     potentially offers similar effectiveness for improving the feeling of 'unsteadiness' and     muscle' fitness as programmes that last much longer. Therefore, the purpose of this research     study is to test the effectiveness of this new, short approach to exercising in patients who     are waiting for a TKR surgery.   "
13171|NCT03113019|"     The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy     method on the basis of autologous antigen-activated dendritic cells in the treatment of     patients with breast cancer.      This technology is intended for complex treatment of patients with breast cancer and is aimed     at preventing the occurrence and treatment of secondary foci. The need for this technology is     justified by the widespread occurrence of breast cancer among women, a decrease in the     average age at onset of the disease and a young age, and the chemoresistantness of locally     advanced forms of cancer.   "
13172|NCT03113006|"     Background Diabetic eye disease is the most frequent complication among the 320,000 Danes     with diabetes. The formation of new vessels (PDR) in the inner part of the eye (retina) is a     feared complication and a leading cause of blindness, since these vessels are fragile and     often cause bleeding within the eye. Peripheral retinal laser treatment (PRP) halves the risk     of blindness, but often comes with a high prize. The peripheral part of the retina is     responsible for the visual field and the night vision, and PRP limits these abilities (i.e.     loss of driving license).      The technique of PRP has principally been the same for the past 40 years with standard     treatment given for all patients. With this one size fits all approach, a substantial number     of patients will either be treated too much or too little. Too little treatment is     inefficient, and disease progression may occur. Excessive treatment may cause side effects     like loss of visual fields and decreased night vision. Therefore, it is important to test if     treatment can be applied on an individual basis to give high efficacy treatment with minimal     side effects.      IMPETUS 2018 - TREAT is the second of two studies aimed at making an individual design for     retinal laser treatment. In IMPETUS 2018 - DETECT the investigators demonstrated that     non-invasive examinations of the oxygen level and measurements of the retinal vascular tree     provide important information of individual treatment response. For instance, if standard PRP     led to three per cent higher retinal oxygen saturation, there was a 4-fold risk of disease     progression despite treatment. Hence, such a patient would benefit from more treatment to     avoid blindness. With these observations at hand, the investigators want to compare a less     invasive treatment (individualized laser treatment) against the standard PRP.      Another essential aspect in the treatment of PDR is to be able to give the right diagnosis     and to evaluate the efficacy of laser treatment. So far, this has been performed by     fluorescein angiography. However, this examination are highly person-dependent and unpleasant     to patients, and a more objective approach is needed. Optical coherent tomography angiography     (OCT-A) is a quick, noninvasive scanning of the retina which is ideal to visualize moving     objects like blood within the retinal vessels. The method has been successfully implemented     in a number of retinal diseases, but it has never been validated in PDR.      Standard PRP is often performed in 3-4 sessions. However, it may be painful, and patients     sometimes choose not to complete all sessions after the initial treatment has been given.     There is insufficient knowledge of the patient-barriers to treatment, and it is important to     address these in an individualized treatment design.      Aim In this 6-month 1:1 randomized, prospective study the investigators want to investigate     1) whether individualized retinal laser treatment compared with standard PRP has the same     efficacy but less side effects, 2) whether OCT-A can be used as an objective marker for     disease activity, and 3) to obtain a better understanding of patient-reported barriers to     standard laser treatment PRP and whether these can be addressed with personalized retinal     laser treatment.      Setup Fifty eight consecutively recruited patients (1 May 2017 - 30 April 2018) with newly     diagnosed PDR referred to the Department of Ophthalmology, OUH, and randomly assigned to     standard PRP (n=29) or individualized laser treatment (n=29).      Intervention Standard laser treatment is performed in all four quadrants of the retina.     Individualized laser treatment is only performed in the part(s) of the retina with     proliferation(s).      Both treatments are carried out at baseline (BL), and additional treatment is given at month     three (M3) and/or (M6), if necessary.      Investigations Retinal digital images, fluorescein angiography, OCT-A (BL, M3, M6). Test of     visual fields, dark adaptation and quality of life (BL, M6). Semi-structured interview will     be performed with five patients who have received PRP in one eye and individualized laser     treatment in the other eye. This will address treatment experience, potential barriers to     treatment, etc.      What to measure:      Differences in need for retreatment, night blindness, visual fields, visual acuity, bleeding     in the eye, surgery, and quality of life between the groups.   "
13173|NCT03112993|"     Spine surgery is one of the most common operative procedures in the United States. It is     performed in the prone position (a patient laying on belly). Muscle relaxants are given for     neuromuscular blockade often referred as paralysis for surgical exposure which is maintained     until the patient is returned to the supine position (a patient laying on back) at the end of     surgery. At the end of the surgery the paralysis is reversed with a drug (neostigmine). A new     drug (sugammadex) has the ability to rapidly reverse the paralysis but it is not well     investigated in elderly. This study will investigate speed of recovery and complications of     the two reversal drugs in elderly patients (age ≥ 65 years) undergoing posterior spine     surgery.   "
13174|NCT03112980|"     Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic     stenosis at intermediate operative risk of mortality, as assessed by the STS-PROM-Score, in a     1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve     replacement (SAVR) to test, whether TAVI is non-inferior to SAVR regarding short and     long-term mortality (1 and 5 year).   "
13175|NCT03112967|"     The investigators will investigate the safety and efficacy of low-volume preparation (Oral     Sulfate solution) compared to 4L PEG solution in bowel preparation before colonoscopy.      One aim of this study was to investigate the efficacy of low-volume preparation (Oral Sulfate     solution) on bowel preparation before colonoscopy.   "
13176|NCT03112954|"     Introduction: Bruxism is a parafunctional habit that affects the stomatognathic system and     its support structures. Usually associated with stress and mostly occurring at night, bruxism     leads to sleep disorders and daily tension headaches. Aiming to rebalance the emotional and     physical state of patients, floral-essence therapy lacks side effects or drug interactions,     and has been recognized by the World Health Organization. Aim and Methods: The investigators     created a buccal-relaxant formula, combining 8 floral essences and testing it in a     double-blind clinical assay conducted in bruxism patients. Results: An alcohol solution of     the buccal relaxant containing Daughter of Gaia floral essences of Taraxacum officinale,     Antirrhinum majus, Fuchsia × hybrida, Bidens bipinnata, Campanula carpatica, Achyrocline,     Nymphaea caerulea, and Tetraoensis riparia significantly attenuated temporal headaches in the     bruxism patients compared to the placebo group (69.46%±1.79 versus 3.55%±1.37, P=0.0001).     Moreover, patients after 21 days using the buccal relaxant increased their quality of sleep     and experienced attenuated jaw-muscle rigidity or morning mouth-opening difficulties. Less     masseter hypertrophy and reduced sensitivity due to abfraction of enamel facets were noted as     well. Conclusions: The buccal-relaxant formula may have sedative properties, preventing daily     temporal headaches in sleep-bruxism patients, suggesting a muscle-relaxation effect. Although     the results are promising, long-term studies are needed to clarify the pharmacological     mechanism of each floral essence in the buccal-relaxant formula and their tolerance effects.   "
13177|NCT03112941|"     To observe modified Barthel index, American Spinal Injury Association (ASIA) impairment scale     grading, sensory score and motor score in patients with incomplete SCI in the plateau using     0.2 MPa HBO combined with pedicle screw fixation and decompressive laminectomy so as to     investigate the effect of HBO therapy on incomplete SCI in the plateau.   "
13178|NCT03112928|"     This international, multi-center, double-blind, randomized, controlled clinical trial aims to     evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as     treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used     to predict motor volition and then use the decoded movements to control virtual and augmented     reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR     environments are used in PMI with the difference that subjects will imagine rather than     execute phantom movements. Electromyography is used to monitor for no muscular activity in     PMI.   "
13179|NCT03112915|"     In this study, investigators aimed to compare the Quadratus Lumborum Block and the     Transversus Abdominis Plan Block for postoperative pain control after laparoscopic     cholecystectomy   "
13225|NCT03112317|"     This study investigate associations between mild hypothermia (patients' core temperature ≤     36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in     patients undergoing major abdominal surgery.   "
13226|NCT03112304|"     The overarching goal of this project is to study the sustainability of MATCH-ADTC within     community mental health clinics, to learn what is needed for evidence-based practices (EBPs)     to take root and thrive within a public system.   "
13181|NCT03112889|"     McArdle disease is a metabolic myopathy characterised by the absence of glycogen     phosphorylase in skeletal muscle. Sodium Valproate is part of a group of drugs known as     histone deacetylase inhibitors, which have a direct effect on chromatin. Recently a drug     trial in an animal model of McArdle disease showed that sodium valproate stimulated the     expression of a different isoform of the missing enzyme in skeletal muscle.      A safety and feasibility study of sodium valproate in people with McArdle disease has been     carried out in London (UK) and Copenhagen (DK) since January 2015. Participants will receive     20mg/Kg/day of sodium valproate for 6 months. The primary outcome measure is exercise     performance assessed by cycle ergometry. Pre and post-treatment skeletal muscle biopsies will     be performed to assess for glycogen phosphorylase. Together with blood analyses for safety.     Additional functional exercise tests will be performed.   "
13182|NCT03112876|"     The goal is this study is to evaluate how the skin surface lipid composition is correlated     with overall sebum production, barrier function, and inflammatory disease status. We     hypothesize that there will be differences in the skin surface composition among subjects of     various groups:        1. Young vs older healthy population        2. Atopic dermatitis vs Acne vs Healthy controls        3. Active smokers vs non-smoker controls   "
13183|NCT03112863|"     Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects.     This will take place over a 12 week period.   "
13184|NCT03112850|"     Sensorineural type of hearing loss is the most common sensory deficit among older adults.     Some of the psychosocial consequences of this condition include difficulty in understanding     speech, depression and social isolation. Studies have shown that older adults with hearing     loss show some age-related cognitive decline. There is no clinically proven method to predict     the onset of this condition, as its occurrence is slow and progressive, affecting both ears     equally. Although hearing aid use and auditory training have been proven as successful     interventions to alleviate sensorineural hearing loss, no research has been designed to look     at the effect of both hearing aid use coupled with auditory training on cognitive performance     in older adults. This study will investigate whether wearing hearing aids will improve the     impact of auditory training on cognition, mood and social interaction for older adults with     sensorineural hearing loss.      This is a crossover trial targeting older adults between 50 and 90 years with either mild or     moderate symmetric sensorineural hearing loss. Consented, willing participants will undergo a     six month intensive auditory training program (active control), as a rigorous means of     examining the impact hearing aid use has on a person's cognition, mood and social     interaction. Participants will be assigned in random order to receive hearing aid     (intervention) for either the first three or last three months of the six month auditory     training program. Each participant will be tested at baseline, three and six months on a     battery of computer based cognitive assessments, together with mood, and social engagement     measures. Effectiveness of hearing aids and auditory training will be evaluated using an     online speech perception test (SPT) and the Abbreviated Profile of Hearing Aid Benefit     (APHAB) Inventory.      This study will investigate whether using a hearing aid coupled with auditory training can     improve a person's cognition and learning abilities, relationships with family and friends,     and quality of life. Results from the study will inform strategies for aural rehabilitation,     hearing aid delivery and future hearing loss intervention trials.   "
13185|NCT03112837|"     Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral     Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.   "
13186|NCT03112824|"     Patients who are involved in a clinical protocol driven 12 week medical weight loss     intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root     extract. The study endpoints are primarily the patients self-reported perception of life     stress and sleep quality. The working hypothesis of this study is that the addition of     aschwagandha to .the medical weight loss program will improve the self-reported perception of     life stress and sleep quality   "
13187|NCT03112811|"     The purpose of this study is to compare the effect of the autogenic drainage and the     intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the     thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child     with the ventilatory support.   "
13188|NCT03112798|"     Miller blades are commonly used in pediatric anesthesia; however, there is less     evidence-based information on the superiority of Miller blades in the visualization of the     laryngeal inlet to Macintosh blades. The aim of the present study is to compare the glottic     views with the size 0 Macintosh and Miller laryngoscope blades above and below the     epiglottis.   "
13189|NCT03112785|"     Main question: Will use of a stem design that allows anatomical reconstruction of the hip     joint improve the outcome in terms of hip function and patient satisfaction without causing     any adverse effects?      Background: Total hip arthroplasty with use of the most well documented implants is a safe     and cost-effective procedure. In the Swedish Hip Arthroplasty register the CLS stem has a 16     years implant survival of 97, 5 %. It is a classic design which requires resection of most of     the neck. The stem also intrudes into the greater trochanter which in patients with certain     types of proximal hip anatomy makes proper introduction of the stem difficult. Finally it has     a standard stem length which will jeopardise future stem removal should there occur any late     infection or instability problems.      Short uncemented stems have been introduced to enable a more anatomic reconstruction of the     hip joint and to cause less invasion of the femoral canal to facilitate future revision     should it be necessary. A more conservative resection of neck could also be of value to     improve the clinical outcome by improved hip function and patient satisfaction.      Purpose of the present study and design: In a prospective study the clinical outcome, stem     fixation and bone remodelling around a short stem (Fitmore) will be studied. The main focus     will be to evaluate patient reported outcomes especially concerning function, over all     satisfaction, pain and activity. All patients will receive the same cup (Trilogy). This cup     is chosen because it has a very thorough documentation in prospective RSA studies and in the     Swedish hip arthroplasty register. All cups will be supplied with insert made of high     molecular polyethylene (Longevity).      Number of hips in the study: 44 consecutive cases   "
15735|NCT03079518|"     Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with     isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study     aims at identification of the optimal target population for a follow-up (main) study.   "
13205|NCT03112577|"     To assess the effects of REGN3500, dupilumab, REGN3500 and dupilumab compared with placebo,     on inflammatory gene expression after a bronchial allergen challenge (BAC) in adults with     mild allergic asthma   "
13206|NCT03112564|"     Prospective study conducted between March 2013 and November 2014 at Hospital Universitario     Puerta de Hierro-Majadahonda, in Madrid, Spain to identify complications and evaluate the     efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without     the use of muscle relaxant and analgesic drugs.   "
13231|NCT03112239|"     The objective of this study is to evaluate the effects of LED phototherapy associated with a     resistance training protocol on the peripheral muscle function of moderate to severe     asthmatic patients ..   "
13190|NCT03112772|"     Changes in alveolar bone following teeth extraction can compromise implant placement. Socket     preservation (alveolar ridge preservation) is considered as a surgical procedure employed to     preserve the ridge volume within the envelope existing at the time of extraction.The ultimate     aim of such procedure is to compensate the expected amount of horizontal and vertical     alveolar bone resorption. In order to better understand which socket preservation materials     might be more effective for ridge preservation and to strengthen the evidence that is     relevant to the clinicians' choice of socket preservation materials, two different materials     were compared in a randomized controlled approach. (1) Demineralized Bone Matrix (DBM) Putty     and Putty with Chips allograft covered by collagen membrane, and (2) Deprotonated bovine bone     xenograft covered by collagen membrane. The independent variable is the grafting material     while the dependent variables are the change in socket height, and width; the ability of     implant placement without the need for grafting and the success rate of implants at the time     of loading.   "
13191|NCT03112759|"     This study will assess cognitive behavioral therapy as an adjunct to conventional symptom     control for patients with chronic pancreatitis.   "
13192|NCT03112746|"     Children with Developmental Coordination Disorder (DCD) have difficulties performing daily     activities which reflects negatively on participation, impacting their lives. To date, there     are a number of interventions to improve performance of these children on activities they     want or need to. In Brazil, there is little research on the efficacy of such approaches. Our     main objective was to start a set of studies to examine the effects of the Cognitive     Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on     occupational performance and satisfaction of Brazilian children who have DCD; to examine     whether children were able to transfer strategies and skills learned during CO-OP to     untrained goals.   "
13193|NCT03112733|"     This study evaluates the usefulness of serum levels of trefoil factor 3 (TFF3), secreted     frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear     factor (NF)-κB as potential diagnostic and prognostic biomarkers in endometrial and ovarian     carcinoma.   "
13194|NCT03112720|"     The purpose of this study is to compare a pain block in the midface, versus the traditional,     more invasive, therapeutic epidural patch for the treatment of headaches   "
13195|NCT03112707|"     Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy®     stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk.      Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease     (stable as well as acute coronary syndromes) who qualify for percutaneous coronary     interventions.      Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm,     multicentre trial, powered for non-inferiority with respect to objective performance criteria     (OPC).      Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor     for a duration of 1 month, after which single antiplatelet therapy with aspirin will be     recommended indefinitely. In case of need for oral anticoagulation, patients will receive an     oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.      Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable     stent thrombosis at 1-year follow-up.   "
13196|NCT03112694|"     The purpose of this study is to understand how people with neuroendocrine tumors respond to     treatment with lanreotide after having received treatment with octreotide.   "
13197|NCT03112681|"     Study SARO.16.004.02 is a prospective, multicenter, randomized, double-blind,     placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar     magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis. A total 36 subjects will     be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar     magnesium 4 mg or placebo. The primary objective is to investigate the effect of a 16-week     treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with     Primary Biliary Cholangitis.   "
13198|NCT03112668|"     This pilot clinical trial studies how well acceptance and commitment therapy works in     improving well-being in patients with stage III-IV cancer and their partners. Learning how to     accept negative thoughts and feelings and how to live in the present without worrying about     the future or past may improve coping skills in patients with stage III-IV cancer and their     partners.   "
13199|NCT03112655|"     The study validates the diagnostic performance of cerebrospinal fluid neopterin     quantification and of blood and cerebrospinal fluid trypanosomal spliced leader RNA detection     for assessing outcome after treatment of human African trypanosomiasis.   "
13200|NCT03112642|"     To help determine if there is improved pain relief when a device that makes an arm muscle     move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent     feeling of pain (anesthesia) of the upper arm.   "
13201|NCT03112629|"     Multi-centre, multi-national, observational, prospective registry in four central full access     centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per     hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and     percutaneous aortic valve (AV) interventions).      The hypothesis is that the management of patients with severe AS will differ between sites     with on-site access to all treatment modes and those without such facilities.   "
13202|NCT03112616|"     One of the causes of disability in patients suffering from a stroke is postural imbalance.     Sensory stimulation improves the postural symmetry of the subject transitorily and they are     thought to have an effect on the spatial frame of reference through a sensory recalibration.     Studies have shown that sensory stimulation by vibration of neck muscles have an immediate     effect on static balance and when walking. The objective of this preliminary study is to test     the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in     standing position and on spatial frame reference in chronic patients.   "
13203|NCT03112603|"     The purpose of this study is to assess the efficacy of ruxolitinib against best available     therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).   "
13227|NCT03112291|"     The aim of this study was to perform a clinical and microbiological evaluation of teeth with     incomplete apexogenesis and traumatic necrosis that were treated with a revascularization     technique, evaluating the microbial reduction after the use a double antibiotic paste.     Furthermore, the investigation also aims to identify the presence of Enterococcus faecalis     and Porphyromomas gingivalis within the root canal system.   "
13208|NCT03112538|"     The purpose of this study is to evaluate the comparative efficacy of insulin pump therapy     versus multiple daily injections in insulin-taking type 2 diabetes mellitus who are     sub-optimally controlled with premixed insulin regimen. This research is necessary because     many patients with type 2 diabetes mellitus do not meet their glucose targets.      In advanced Type 2 diabetes mellitus, many patients develop worsening diabetes control and     unable to reach the glucose targets despite intensive insulin regimens.This is further     complicated by the risks of low blood sugar and weight gain. These limitations of multiple     daily injection treatment show the need for new treatments for this group of patients.   "
13209|NCT03112525|"     New/direct oral anticoagulants (NOAC/DOAC), like apixaban and rivaroxaban, are an interesting     alternative to unfractionated or low molecular weight heparin relayed by oral anti-vitamin K     anticoagulants (VKA) for the treatment of venous thromboembolism and atrial fibrillation.     This new generation of anticoagulants directly inhibit a factor in the blood coagulation     pathway and have a wide therapeutic range overcoming several practical issues associated with     VKA therapy including the need of routine coagulation monitoring potentially simplifying     patient management. However, despite this wide therapeutic range, a large interindividual     dose variability related to factors such as age, body surface, smoking, concomitant diseases     as well as differences in drug metabolism, could put susceptible patients at risk for     uncontrolled bleeding. Both rivaroxaban and apixaban are cleared primarily via cytochrome     P450 (CYP) mediated hepatic metabolism, mainly CYP3A, and renal excretion, involving the     P-glycoprotein (P-gp). Both CYP3A and P-gp activity show important interindividual variations     due to drug interactions and/or genetic polymorphisms in corresponding genes.      The aim of the current study is to evaluate the impact of cytochrome activity and relevant     polymorphisms on rivaroxaban/apixaban dosage regimen or treatment efficacy in a hospital     setting. The safety issue in this context is particularly relevant, since hospitalisation is     linked to a modification of the patient's treatment with often an increase in the number of     medications. The resulting changes in metabolism due to modified cytochrome and transporter     activities could affect rivaroxaban/apixaban blood concentrations. Our central hypothesis is     that genotype and/or phenotype in CYP3A4/5/7 or P-gp may influence the rivaroxaban/apixaban     plasma concentration and increase the risk of thrombotic or hemorrhagic events. Thus,     investigating how the patient's genotype and/or phenotype for CYP3A4/5/7 and P-gp could     potentially alter the bio-disponibility of rivaroxaban and apixaban and therefore the risk to     develop adverse events or inefficacy would be of particular interest.   "
13210|NCT03112512|"     To Select the Optimal Positive End-expiratory Pressure in Moderate and Severe Acute     Respiratory Distress Syndrome Patients by Using:        1. the novel Non-invasive Electrical Impedance Tomography Guided Method        2. the Protective ventilation tool G5(MV)   "
13211|NCT03112499|"     The main aim of the study is to investigate and compare the possible acute effect of standard     PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy     (stone-free rate), safety (complication rate, long-term kidney function) and other parameters     (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations     (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.   "
13212|NCT03112486|"     Few early prognostic indicators are currently available for patients' families and clinicians     following out of hospital cardiac arrest (OHCA), and blood biomarkers may be of prognostic     value in these cases. Brain tissue is highly dependent upon aerobic respiration, and oxygen     deprivation result in irreversible neuronal cell injury. Peptides released into the blood by     injured neuronal cells can be measured to estimate degree of injury, and potentially predict     long term neurological outcome.   "
13213|NCT03112473|"     This proposed study aims to compare the effects of unilateral and bilateral transcutaneous     electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS +     task-oriented training (TOT) with unilateral TENS+TOTin improving upper limb function in     patients with chronic stroke.      The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not     significantly different in promoting the recovery of upper limb functions.   "
13223|NCT03112343|"     This is a 24-week, open-label, randomized, multi-center trial conducted in two tertiary     hospitals. There are three follow-up measures; at baseline, post-intervention at Week 12, and     Week 24. Subjects diagnosed as type 1 DM, type 2 DM, and/or post-transplant DM, initiate     basal insulin or intensify insulin regimen to basal-bolus regimen. After the given education     on insulin dose titration and prevention for hypoglycemia and 1 week of run-in period,     subjects are randomized in a 1:1 ratio to either the ICT-based intervention group or the     conventional intervention group. Subjects in conventional intervention group will save and     send their health information to the server via the PHR app, whereas those in ICT-based     intervention group have additional algorithm-based feedback messages. The health information     includes levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and     number of steps. The primary outcome will be the proportion of patients who reach an optimal     insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or     unscheduled clinic visits.      This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE,     Korea) under Industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT     Clinical Trial System and Foundation for Industrialization.)   "
13396|NCT03110081|"     This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural     analgesia for pain control and opioid consumption through the third postoperative day in     patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion     criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.   "
13233|NCT03112213|"     This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate     the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID     use in a representative cohort of participant with moderate to severe active RA who have     either responded inadequately to, or who were intolerant to previous therapy with one or more     synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made     the individual decision to initiate tocilizumab (subcutaneous [SC] or intravenous [IV]) as     first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the     summary of product characteristics (SPC).   "
13235|NCT03112187|"     To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of     Haemoglobin and Haematocrit levels   "
13236|NCT03112174|"     This Phase 3 multinational, randomized, double-blind study is designed to compare the     efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo     in subjects with MCL.   "
13237|NCT03112161|"     This study will determine whether changes in energy balance alter regional neuronal     activation of brain regions associated with food intake in individuals screened to be either     resistant or prone to obesity. Specifically, it will determine whether foods of hedonic     value elicit changes in regional neuronal activity in the fasted and fed state in     obese-resistant and obese-prone men and women in varying states of energy balance.   "
13214|NCT03112460|"     In a prospective, non-randomized study, all of the basic and advanced cardiopulmonary     resuscitations would be analyzed. All resuscitation are planned to be performed by the above     mentioned devices according to the recent protocols. The continuous audio-visual feedback and     all the data obtained during the resuscitation are intended to develop a better CPR training     program in the future.      The downloading of data is planned to occur on the same day of CPR to a data card. After     approximately one week all the participant medical persons would receive a detailed case     analysis. Elimination of the typical errors is targeted.      Monitored quality indicators      Follow-up of CPR protocol:      elapsed time between turning on device and first chest compression elapsed time between     turning on device and first delivered shock elapsed time between turning on device and first     delivered shock in case of shockable rhythm compliance with 2 minutes long CPR period     recognition of rhythm, recognition of adequate therapy, follow-up of the protocol concerning     DC-shock recording the exact moment of the following procedures (with the use of Code Marker     button on the defibrillator device) endotracheal intubation drug therapy obtaining     intravenous access oxygen therapy      Quality of chest compressions:      depth frequency release compression fraction      Discontinuance of chest compression - cause anf time interval (Code Marker) endotracheal     intubation ventilation rhythm analysis and defibrillation obtaining intravenous access      Other data (obtaining with manual recording):      cause of sudden cardiac death initial rhythm exact time of sudden death eyewitness records     data of the patient monitoring system (only optional) description of place participant of CPR     first detection medical documentation   "
13215|NCT03112447|"     To compare surgical outcomes from medial epicondyle fracture fixation with absorbable     cartilage nails to those from traditional Kirschner wire fixation.   "
13216|NCT03112434|"     To date, clinical tests are unable to differentiate between the cause of muscle stiffness,     although a manual instrumented spasticity assessment for the lower limb that utilizes surface     electromyogram has recently been proposed. This study intends to use shear wave elastography     to assess individual muscle stiffness parameters and the individual response to botulinum     toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters     could then be used to predict the effect of botulinum toxin type A and ultimately serve as a     basis for development of a treatment model for muscle spasticity in patients with spastic     cerebral palsy.   "
13217|NCT03112421|"     Sample Comparison The objective of this study is to compare the Philips Minicare BNP test     with the Centaur BNP test. BNP level measured in human blood samples (EDTA venous whole blood     and/or EDTA plasma) will be assessed. Matrix Comparison To compare BNP measurements obtained     using Minicare System for EDTA whole blood and EDTA plasma samples.Prior to the study start,     a proficiency study will be performed on the Minicare BNP, Architect and I-STAT BNP assay to     be sure that devices are performing according to expectations. Approximately 100 EDTA patient     whole blood samples covering the entire measuring range of Minicare BNP from LOQ until end of     measuring range (expected to be approximately 5000 ng/L) (Ref 7) will be tested (according to     CLSI EP09A3 (Ref 5)) at a central laboratory using the Minicare BNP, Alere BNP, I-STAT BNP     system. The outcome of the site routine assay (Centaur BNP systems) will be used to evaluate     if the blood samples cover the entire distribution range of the assay. If necessary, up to     20% of the samples may be spiked so that the entire range of the assay is covered. The     central laboratory will identify the blood tubes with a BNP request. Approximately 1000 μl     EDTA whole blood will be available (left over material) for testing on the non-routine     devices (i.e., Minicare BNP, Alere BNP, and I-STAT BNP). Testing for the Alere BNP, I-STAT     BNP, and Centaur BNP systems will be performed according to the respective IFU's (Ref 1, 2,     3, 4). For the Minicare BNP system, test will be performed according to a DRAFT IFU or a     similar document describing the sample treatment and handling for the Minicare BNP system.     Alere BNP, I-STAT BNP and Minicare BNP samples should be tested within 6 hours after     collection and Centaur BNP samples within 8h of collection. Although different stability     claims for BNP, it is highly recommended to perform all measurements on all systems within 2     hours. For Alere BNP, I-STAT BNP, Centaur BNP analysis will be performed using a single blood     sample for each patient. Alere BNP and I-STAT will use EDTA whole blood samples as sample     type Centaur BNP will be tested on EDTA plasma samples. For the Minicare BNP, both EDTA whole     blood and EDTA plasma will be tested for each patient. For the Minicare BNP system the whole     blood samples will be tested using a pipette and the same sample will be tested using the     SmearSafe Blood Dispenser (transfer device) to investigate a reliable use of such transfer     device.      Only the routine Centaur BNP outcomes will be used as part of support for patient diagnosis.   "
13218|NCT03112408|"     This research aims to highlight the key roles of the cerebellar and cortical fronto-parietal     networks in the coupling of eye movements with visual perception and visuo-spatial attention.   "
13219|NCT03112395|"     The demographic shift and the increasing prevalence of chronic wounds represent major     challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial     ulcer, mixed ulcer, diabetic foot ulcer) persist for months or years with a very slow or even     no healing progress. Patients suffer from pain and immobility, which dramatically reduces     their quality of life. Complications such as infections or tissue necrosis can lead to a bad     outcome and amputation of extremities.      The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines     the technologies of pulse modulated magnetic fields and light emission locally applied to the     wound area. The investigational medical device represents a promising combinational     therapeutic approach to synergistically increase the tissues regenerative potential. By     stimulating electrophysiological processes at the site of injury, the cells regain its     capacity to efficiently regenerate the injured or diseased tissue. It is expected that the     patient benefits from a faster healing process, reduced inflammation as well as an improved     overall treatment outcome.   "
13220|NCT03112382|"     Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus     (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic     control in patients with type 2 diabetes   "
13221|NCT03112369|"     Investigators will conduct a two-arm, comparative effectiveness randomized controlled trial     of two culturally adapted, empirically based programs (EBP) - Narrative Exposure Therapy     (NET) vs. Motivational Interviewing with Skills Training (MIST) in terms of lowering HIV     sexual-risk behaviors (HSB) for American Indian / Alaska Native (AIAN) men and women. NET     addresses Posttraumatic Stress Disorder (PTSD) as a pathway to preventing substance use     disorders (SUD) and HSB whereas MIST addresses substance misuse as a way of preventing SUD     and HSB.   "
13222|NCT03112356|"     Infectious endocarditis is a serious pathology with difficult diagnosis especially on     prosthetic valves or cardiac device because of the plurality of clinical presentations and     the low sensitivity value of echocardiography in these patients. Despite a well validated     indication for the detection of septic emboli, the value of FDG-PET for the detection of     prosthetic valves or cardiac implantable device is still unclear especially because of     frequent non-septic inflammatory processes.      To improve the specificity value, the use of radio-labeled leukocytes scintigraphy is     conventionally proposed. An alternative method is to label leukocytes in vivo with an     anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used     in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To     knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or     cardiac device infection had not been studied.   "
13238|NCT03112148|"     This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over,     single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release     rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting     conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.   "
13239|NCT03112135|"     The effect of tranexamic acid (TXA) on bleeding and improvement of surgical field during ear     exploration surgery is not clear yet. This study will conducted to answer this question.   "
13240|NCT03112122|"     Randomized, controlled, three-arm, double-blind study : control group, treated with core     decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of     autologous BMC.   "
13241|NCT03112109|"     Against the background of the European Innovation Partnership on Active & Healthy Ageing,     SmartCare aims to define a common set of standard functional specifications for an open ICT     platform enabling the delivery of integrated care to older European citizens.      In the context of SmartCare, a total of 23 regions and their key stakeholders will define a     comprehensive set of integration building blocks around the challenges of data-sharing,     coordination and communication. Nine regions will then deploy integrated health & social     services to combat a range of threats to independent living commonly faced by older people,     while the others will prepare for early adoption, possibly in the framework of new ICT PSP     projects. In a rigorous evaluation approach, the deployment sites will produce and document     much needed evidence on the impact of integrated care, developing a common framework suitable     for other regions in Europe. The organisational and legal ramifications of integrated care     will be analysed to support long term sustainability and upscaling of the services.      SmartCare services will provide full support to cooperative delivery of care, integrated with     self-care and across organisational silos, including essential coordination tools such as     shared data access, care pathway design and execution, as well as real time communication     support to care teams and multi-organisation access to home platforms. In addition, they will     empower all older people according to their mental faculties to take part in effective     management of their health, wellness, and chronic conditions, and maintain their independence     despite increasing frailty.      The SmartCare services build on advanced ICT already deployed in the pioneer regions,     including high penetrations of telecare and telemonitoring home platforms. In SmartCare,     these platforms are to be opened to cross-sectorial care teams, improving the ability of     older people to better manage their chronic conditions at home and deal with their increasing     frailty. System integration will be based, whenever possible, on open standards' multivendor     interoperability will be strongly encouraged.   "
13242|NCT03112096|"     This is a study to evaluate biodistribution, pharmacokinetics and safety of [18F]THK-5351     positron emission computed tomography in Cognitively Healthy Subjects and Patients with     Alzheimer's Disease.   "
13243|NCT03112083|"     The aim of this study was to systematically collect data on safety and tolerability of krill     powder in humans and simultaneously gain efficacy data by measuring the risk factors for     cardiovascular disease.      The study was a randomised, double-blinded, placebo-controlled intervention study with     slightly obese subjects with mildly or moderately elevated blood pressure. Study was     conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35     subjects were randomised according to randomisation list to two groups (krill powder or     placebo) in a balanced manner (1:1), separately for both gender and site. Concealed     allocation was used to keep both subjects and staff blinded. The study consisted of a     pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week     safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day     56.      As a primary endpoint of the study, the total number of reported adverse events were compared     in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of     placebo for the 8-week follow-up period.   "
13244|NCT03112070|"     Hypertension is the most prevalent cardiovascular disease risk factor among individuals 60     years of age and older. Hypertension can be prevented and modified with lifestyle     interventions that include regular exercise. Water exercise is widely recommended for older     adults for a variety of health benefits, but few studies have assessed the immediate     ambulatory blood pressure (BP) response to water exercise, a response termed postexercise     hypotension (PEH). We will assess PEH after a session of water aerobics in physically active,     older women with hypertension. Twenty-four women will be randomly assign to participate in a     45 min session of moderate intensity, water aerobics (WATER) and a 45 min land control     session (CONTROL). All experimental sessions will start at 9 am sharply with 7 days between     them. Subjects will left the experiments wearing an ambulatory BP monitor for the next 21 hr.   "
13245|NCT03112057|"     The purpose of this experiment is to establish a solid medical foundation for the successful     development of non-invasive harmonic generation (HGM) microscopic slicing methods. The     purpose of this new technology platform is to directly observe the nerve endings of     nociceptors To enhance understanding of how neuropathies occur, persistence, and ease. This     technique will assist in the diagnosis and prognosis of patients with neuralgia.   "
13246|NCT03112044|"     In this study HCV negative recipients will be transplanted with HCV positive lungs.     Investigators will attempt to decrease infectivity rates by performing Normothermic Ex vivo     Lung Perfusion (EVLP), which is an approved method of donor lung preservation, assessment and     treatment, and could be an excellent platform to reduce/eliminate hepatitis C virus. Patients     will be treated by the standard approved direct-acting antivirals (DAAs) if infection occurs.     It is planned to enrolled 20 patients from the Lung transplant wait list in this study.     Patients will be followed for 6 months. This will be a single center pilot study.   "
13247|NCT03112031|"     The purpose of this study is to develop initial efficacy, feasibility, and safety data     regarding the use of Tamoxifen in combination with amphotericin B and fluconazole in the     treatment of cryptococcal meningitis. The results of the study will inform the design and     feasibility of a larger study powered to a survival endpoint. The study hypothesis is that     adding tamoxifen to standard antifungal therapy increases the rate of clearance of yeast from     cerebrospinal fluid. Increased rates of clearance of yeast from cerebrospinal fluid have     previously been associated with improved clinical outcomes, including survival and     disability.   "
13272|NCT03111706|"     Prospective observational study conducted on women with previous 1 or 2 CS candidate for     elective CS. Ultrasonographic evaluation of lower uterine segment using 2D and 3D     transabdominal and transvaginal then correlated to scar integrity assessed intraoperatively   "
13273|NCT03111693|"     Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early     atherosclerosis.      Coronary artery calcium measured by CT is known as a robust predictor to predict risk for     cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show     that other CT risk factor exists, independent of calcium scoring, such as epicardial fat,     intrathoracic fat and visceral fat.      The aim of this prospective study is to evaluate these new cardiovascular risk markers in     obese patients, using standard dose CT and low dose CT with adaptative statistical iterative     reconstruction.   "
13248|NCT03112018|"     The purpose of this study is to determine whether a combination of evidence-based strategies     can improve intrapartum and newborn care in facilities to reduce mortality among preterm     infants. This will be a cluster randomized implementation science study across 23 facilities     in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities     to measure impact during the study period. These interventions are: a) data strengthening and     data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an     emphasis on preterm labor and preterm babies; c) simulation-based provider training and     mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of     Quality Improvement (QI) cycles to identify and resolve facility-specific issues and     bottlenecks. A two-stage design will be used where all study facilities will receive some     aspects of the intervention initially, namely data strengthening and the modified checklist.     Subsequently, the remaining interventions (QI cycles and simulation training of providers)     will be rolled out to a randomly selected half of the facilities in the first stage. At a     second stage, the remaining half of the facilities will receive the remaining interventions.   "
13249|NCT03112005|"     More than 29 million people in the US are living with diabetes, many of whom will develop     diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye     disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual     eye screening is recommended for all diabetic patients since vision loss can be prevented     with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages.     Currently, the number of clinical personnel trained for DR screening is orders of magnitude     smaller than that needed to screen the large, growing diabetic population. Therefore, to meet     this large unmet need for DR screening, a fully-automated computerized DR screening system is     necessary.      EyeArt is an automated screening device designed automatically analyze color fundus     photographs of diabetic patients to identify patients with referable or vision threatening     DED. This study is designed to assess the safety and efficacy of EyeArt.   "
13250|NCT03111992|"     The purpose of this study is to assess the safety, tolerability, and identify the recommended     doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients     with relapsed and/or refractory multiple myeloma.   "
13251|NCT03111979|"     The older population is the fastest growing age group worldwide, but it is also the most     susceptible to chronic diseases and disabilities. One of the most common negative     consequences of aging is the decline in muscle mass, strength and power. This is most notable     in lower limb muscles. These muscles are required for the performance of daily activities     including walking, stair climbing and standing up from sitting. Regular exercise is     considered one of the most effective measures to slow, and even reverse the progression of     muscle weakness. Nevertheless older adults may notice a decline in their capability to     undertake regular exercises, this may be due to a decline in their muscle's ability to buffer     pH. Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to     the extension of physical performance, counteracting the decline the muscle's ability to     buffer pH. Yet this pH buffering process it largely restricted by the amount of β-alanine     available in the human body. β-alanine is already known to decline in older individuals due     to a reduction in food products (meat, fish and poultry). Yet through either consumption of     β-alanine rich food, or through short-term supplementation, β-alanine is raised, increasing     carnosine concentrations. Improved β-alanine levels can potentially advance exercise     performance, for example significant improvements in time to exhaustion on both a constant     (37%) and incremental (12%) treadmill tests have been demonstrated. It is therefore proposed     that via β-alanine supplementation, an individual's perception of their frailty, maintenance     of health and independent living can be improved in older individuals.      However, these findings are based on participants, both young and older, who are well-rested     with no prior exercise or fatigue to the assessed muscles. It remains unclear if β-alanine     supplementation will aid in the buffering of pH when the muscle has already been fatigued.     Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation     on lower limb contractile and force properties, pre and post muscle specific fatigue.   "
13252|NCT03111966|"     This is a multicentre, descriptive, observational and ambispective study carried out in     patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in     Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the     Networked Biomedical Research Centre for Hepatic and Digestive Diseases).   "
15754|NCT03079271|"     To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear     osmolarity and surface topography in human subjects with dry eye disease.   "
13253|NCT03111953|"     Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than     all other bariatric surgical procedures, and it is hypothesized that this procedure has     specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD     procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity     and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in     Rome, Italy. The purpose of this study is to provide a better understanding of the effect of     the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It     is hypothesized that weight loss achieved with BPD surgery will have greater effects on     insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric     bypass (RYGB).   "
13254|NCT03111940|"     The OxOPT-PCI study addresses patients with coronary artery disease who are referred to the     John Radcliffe Hospital because of the need for treatment with an intra-coronary stent (metal     scaffold) for clinical reasons. Although, this has become a highly standardised procedure it     is still challenging for the clinician to assess the final success of this procedure at the     end of intervention with conventional methods. This shortcoming can potentially translate     into a worse clinical outcome for approximately 10 percent of all patients treated with an     intra-coronary stent for this type of disease.      This study (OxOPT-PCI) investigates if the use of blood flow measurements (namely measurement     of fractional flow reserve (FFR)) and intravascular imaging (namely optical coherence     tomography (OCT)) after the implantation of a stent can improve the treatment result for     these patients. Both, FFR and OCT are being used already in daily clinical routing but their     usefulness especially in combination is not clear. In order to standardise the optimisation     procedure we developed a specific algorithm to make sure that all patients receive the same     optimisation measures based on the assessment of FFR and OCT.      The benefit of this specific optimisation algorithm will be assessed by measuring 1) indices     of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by     contacting the patients 12 months after stenting to verify the clinical mid-term success.   "
13255|NCT03111927|"     Research study on the role of early life nutrition on brain and cognitive development during     infancy and early childhood. Two blends of myelin-relevant nutrients at different levels will     be compared and a breastfed group will be considered as epidemiological reference.   "
13256|NCT03111914|"     The purpose of this study is to establish a more accurate and precise way to image (take     pictures of) metastatic bone disease in patients with prostate cancer for staging and     monitoring response to therapy. More specifically, the study aims to evaluate the     capabilities of dual energy CT as a more precise and accurate tool for staging and monitoring     of therapy response in patients with osseous metastases from castrate-resistant prostate     cancer.      Bone metastases in prostate cancer patients are a clinical and diagnostic challenge to image.     Sometimes very small metastatic bone lesions may only become detectable by imaging in     response to therapy due to increased bone deposition during the first three months after     therapy. Commonly used imaging tests (such as regular CT or bone scan) are unable to reliably     tell the difference between increased bone deposition (therapy response) and growth of the     lesion (progressive disease). This diagnostic challenge may have profound negative effects on     patient management since it may require additional imaging before an accurate determination     of tumor response can be made. An appropriate determination of tumor response is needed for     appropriate management of prostate cancer. The investigators anticipate that the new imaging     tested in this study (called dual energy CT) may provide additional critical information in     this clinical and diagnostic challenge.      Approximately 100 people with prostate cancer and metastatic bone disease will take part in     this study. At enrollment, three months, and six months, they will will receive a     non-enhanced (without contrast) dual energy CT scan of the chest, abdomen and pelvis before     receiving their routine, clinical contrast-enhanced CT scan.   "
13257|NCT03111901|"     This study will evaluate the safety and disease control rate of the combination of     pembrolizumab plus low-dose interleukin-2 in patients who have either advanced melanoma or     renal cell cancer.   "
13258|NCT03111888|"     The goal of the small feasibility trial is to establish a method, material, and     patient-specific design that is superior to what is in use today. The first round of patients     are well known to the physician investigator and are familiar with the problem that is being     resolved. The end goal of the project is to create a new patient-specific design that will     last longer, fit better, and cause less trauma to the airway and the patient.   "
13259|NCT03111875|"     We propose to test the hypothesis that aggressive warming reduces the incidence of major     cardiovascular complications, compared to routine care. Half of the participants will be     randomly assigned to routine care (core temperature ≈35.5°C), while the other half will     receive aggressive warming (>37°C core temperature) in a multi-center trial.   "
13260|NCT03111862|"     The aim of this observational study registry is to assess the safety of a Non-ST-elevation     myocardial infarction (STEMI) rapid rule-out strategy as proposed by European Guidelines in     patients presenting with suspected acute coronary syndrome to the emergency department.   "
13261|NCT03111849|"     The prevalence of sarcopenia is high in many organ pathologies such as COPD, but remains     little studied in acute respiratory failure. Sarcopenia is a health problem representative of     frailty, loss of autonomy and decreased muscle strength. The frequency and evolution of     sarcopenia is unknown in patients having chronic bronchic obstruction with exacerbation.   "
13278|NCT03111628|"     This is a Phase IV, single-site study that will examine blood cells or tissue obtained from     CIU patients receiving open-label treatment with omalizumab at the current FDA-approved dose     of 300 mg/month for 12 weeks in addition to standard therapy with anti-histamines. Results     from the 3 Phase III studies in CIU patients provide evidence that a meaningful change in     symptoms is apparent at 1-2 wks. The Minimal Important Difference (MID) is achieved by 70% of     patients by 2 wks on multiple background drugs for hives. The goal is to identity the IgE     bearing cell type associated with clinical symptom change.   "
13536|NCT03108248|"     For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis     (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This     study aimed to investigate whether TACE in combination with irradiation stent placement (ISP)     could prolong the survival in patients with HCC and PVTT.   "
15755|NCT03079258|"     The aim of this study is to determine the effect of aerobic exercise on maternal and     offspring vascular health.   "
13262|NCT03111836|"     Hypertension is a leading risk factor for cardiovascular disease and mortality. Lifestyle     counseling is recommended as a first line therapy for reducing blood pressure (BP) and risk     for cardiovascular events. Recent studies suggest that e-based lifestyle interventions are     effective in evoking therapeutic change in BP1. However, BP response and adherence to     exercise and diet behavior varies significantly after e-based interventions due to variations     in treatment methodologies. Consensus is not yet established for a standardized e-counseling     protocol for hypertension. As noted in our systematic review, the two dominant models of     e-counseling procedures are expert-driven (protocol driven, prescriptive) and user-driven     (self-guided, collaborative). Expert-driven programs prescribe specific changes for lifestyle     behavior which are intended to facilitate compliance to behavioral change. In contrast, the     user-driven method actively involves the subject in goal-setting and/or the selection of the     intervention used to reach the behavioral goal. One conclusion from the systematic review is     that these models are used indiscriminately in e-counseling programs. There is currently     inadequate data to determine the efficacy of programs that are expert-driven vs. user-driven     in reducing BP while modifying lifestyle behaviour. It is possible that a combination of     expert-driven and user-driven features for lifestyle e-counseling is most effective. However,     before these two approaches can be combined, it is essential to establish the strengths and     limitations of each model.   "
13263|NCT03111823|"     This pilot clinical trial studies how well aerobic exercise works in improving quality of     life and health-related outcomes in patients with stage IV colorectal cancer undergoing     chemotherapy. Aerobic exercise during chemotherapy may improve quality of life and reduce     fatigue and inflammation in the blood related to heart disease and diabetes in patients with     stage IV colorectal cancer.   "
13274|NCT03111680|"     This is a cluster randomized study of an environmental level intervention to improve     nutrition and physical activity, among public housing residents. Followup was one year post     baseline   "
13275|NCT03111667|"     A hybrid effectiveness-implementation trial that is designed to assess the effectiveness of     an intervention (The Teen Marijuana Check-Up) when delivered in real world settings. In     addition, the study will assess the frequency of coaching support needed by providers to     maintain adherent skill levels.   "
13264|NCT03111810|"     Currently, 2-3% of the population of the United Kingdom and United States of America receive     glucocorticoid therapy. Significant adverse effects are not confined to chronic use;     recurrent short-course administration is associated with increased morbidity and mortality.     The adverse metabolic features associated with glucocorticoid use include obesity, skeletal     muscle myopathy, hypertension, insulin resistance and diabetes and are collectively termed     'iatrogenic Cushing's syndrome'. The efficacy of glucocorticoid therapy is not in doubt, but     there are no interventions to reduce their metabolic consequences. Within metabolic tissues     (liver, skeletal muscle, adipose), 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1)     regenerates active glucocorticoid and therefore is able to tightly control the availability     of glucocorticoids to activate the glucocorticoid receptor. In preclinical studies, the     investigators have shown that 11β-HSD1 is critical in regulating the development of the     adverse features associated with circulating glucocorticoid excess, endorsing our     observations in a patient with Cushing's disease, who was protected from a classical     phenotype due to a functional deficit in 11β-HSD1.      This study is the first clinical evaluation of the impact of the selective 11β-HSD1     inhibitor, AZD4017, in healthy volunteers taking exogenous glucocorticoids (prednisolone).     The investigators propose that in tissues expressing high levels of 11β-HSD1, prednisolone     action will be amplified, driving adverse effects within these tissues and have hypothesized     that AZD4017 in humans will reduce the adverse metabolic consequences of Prednisolone     administration without compromise to its anti-inflammatory action.      Our specific research objectives are:        1. To demonstrate the beneficial effect of the selective 11β-HSD1 inhibitor, AZD4017, upon          the prednisolone-induced deterioration in metabolic phenotype, including glucose          disposal and endogenous glucose production rates.        2. To determine the impact of AZD4017 on the anti-inflammatory actions of Prednisolone.        3. To identify the tissue-specific (skeletal muscle, adipose) mechanisms underpinning the          response to Prednisolone therapy administered in conjunction with AZD4017.      The investigators will perform a randomized, double-blind placebo controlled study to     determine if co-administration of the selective 11β-HSD1 inhibitor, AZD4017, limits the     adverse effects of short-course exogenous glucocorticoid administration. 32 healthy male     volunteers will have detailed metabolic investigations including 2-step hyperinsulinaemic     euglycaemic clamps (with stable isotope measurements of lipid and carbohydrate metabolism),     as well as assessment of skeletal muscle forearm glucose uptake. All volunteers will then be     treated with Prednisolone (20mg daily) and randomized to the co-administration of placebo or     AZD4017. After 1 week of therapy, all investigations will be repeated. Our hypothesis is that     the adverse metabolic effects of Prednisolone will be reduced by co-administration of     AZD4017.   "
13265|NCT03111797|"     This prospective and observational cohort studies the morphine consumption difference during     the first 48 hours after a lung lobectomy between patients operated with a robot assisted or     a video-assisted technique for a lung cancer lobectomy.      Second outcome was to search eventual cardiac output difference during the surgery in 100     patients (50 in each group) using a non invasive monitoring device of cardiac output      All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were     included.   "
13266|NCT03111784|"     IConsumption of fish provides a vital contribution to the survival and health of a     significant portion of the world's population. Lipids in fish foods consist mainly of     long-chain polyunsaturated fatty acids (PUFAs) such as eicosapentaenic acid (EPA, C20:5n-3)     and docosahexaenoic acid (DHA C22:6n-3) which belongs to the physiologically important group     of n-3 fatty acids. The increase of unsaturated fatty acids, along with the reduction of     saturated fats, supports the lowering of blood cholesterol in humans and causes a positive     impact on human nutrition. Polyunsaturated fatty acids (omega-3 fatty acids) plays a role in     preventing heart disease and has anti-inflammatory and anti-thrombosis effects and these     fatty acids cannot be synthesized and they must be obtained through diet. These nutritional     benefits of fish consumption is mainly attributed to the effect of omega-3 polyunsaturated     fatty acids , which are thought to have several potential cardio protective actions. This     research is focused mainly identify highly consumed food fishes available in Batticaloa     district( fresh, lagoon and sea water ) and their consumption pattern (cooking methods) of     local community and by cardiovascular patients (CV) . Secondly Omega-3- Polyunsaturated fatty     acid (PUFA) and tocopherol content (Vit E) in the fresh fish and dried or smoked fish of the     highly consumed food fishes would be assessed and the relationship between fish consumption     and its PUFA and Vit E content would be known. Also research will focus how lifestyle,     socio-demographic factors' influences on the Cardiovascular diseases among community.   "
13267|NCT03111771|"     Loss of muscle mass (scientific term: cachexia) affects about 80% of patients with advanced     cancer and impacts their prognosis by decreasing tolerance and response to treatment,     decreasing quality of life and survival. The prognosis in these patients depends directly on     the importance of the loss of muscle mass. Preserving it is therefore an essential     therapeutic objective. It is therefore important to understand perfectly the mechanism of     this muscular loss. The accumulation of fat in the muscle (scientific term: myosteatosis)     could be a mechanism responsible for this loss of muscle mass. It is indeed a hypothesis     proved on animal models. Moreover, it has recently been shown that more the cancer patient     loses weight, more his muscle contains fat. This lets think that this deposit of fat in the     muscle would be directly related to the loss of muscle mass. All of these observations could     not be clearly established in humans and investigators are seeking by this study to     illuminate these mechanisms at the human level. A better understanding of these mechanisms     would allow investigator to set up targeted treatments against the accumulation of fat in the     muscle, which would significantly improve the quality of life of patients with cancer of the     aerodigestive pathways and their chances of recovery.      The MYOMEC study includes the inclusion of healthy patients (to form a control group) but     also patients with cancer of the upper aero-digestive tract. The study will be divided into     two parts: clinical examination and nutritional evaluation the day before surgery at the time     of the participants' admission to hospital and then the biological samples during surgery.     The nutritional examination consists in collecting the morphological data of the patient,     namely:      Its weight, size, calculation of the body mass index Tests of muscular strength (wearing     weight of 1, 2 and 3 kilos) Measurement of the percentage of fat mass and lean mass     (Impedancemetry)      In this study, participants benefit from the following investigations:        -  Clinical examination complete with elaboration of the clinical nutritional status,          realized the day before the surgical intervention in hospitalization.        -  Elaboration of the radiological nutritional status by a complementary analysis of the          scanner envisaged in the balance of extension of the disease        -  Performing surgical site sampling during surgery without additional invasive procedure          and under general anesthesia. It will be realized:      A muscle biopsy of the sterno-cleido-mastoid muscle (neck muscle) (maximum volume 5 mm3), A     tumor biopsy (maximum volume 5mm3). A blood sample (maximum volume 5ml)      No invasive procedure, supplemental examination or additional consultation is required for     the whole off-set study for the extensive muscular percutaneous biopsy regarding which     additional patient agreement will be required. No additional follow-up is required when     participating in this study. Participation in this study does not entail any particular     constraint or additional treatment. The duration of the patient's participation is defined as     follows: from the date of the preoperative consultation or from the consultation of     announcement until his / her discharge from hospital. The exclusion period defined in this     study extends from the date of inclusion of the patient to the date of the surgical     procedure, during which time the patient can not participate in another clinical research     protocol.   "
13268|NCT03111758|"     Rationale:      Stent therapy has been proven to be an effective form of therapy in the treatment of chronic     iliofemoral and iliocaval post-thrombotic obstruction. During the first post-intervention day     intermittent pneumatic compression stockings (IPCS) are necessary to augment venous flow.     This will inherently prevent early stent occlusion. Our aim is to investigate whether the     Geko device is effective as IPCS regarding augmentation of flow in post-thrombotic patients     during the first day after stenting.      Objective: The primary objective of this study is to identify whether the Geko system is     effective in augmenting flow compared to IPCS in post-thrombotic limbs before after stenting.      Study design: Interventional pilot study with randomized cross-sectional design.      Study population: Patients with a post-thrombotic obstruction undergoing a percutaneous     procedure (PTA, stenting).      Intervention (if applicable): Treatment with intermittent pneumatic compression stockings     (IPCS) and Geko-device.      Main study parameters/endpoints: The main endpoint and parameter of this study is     time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography using its     pulse wave Doppler function.   "
13270|NCT03111732|"     Background:      Biliary tract cancers are rare but they are serious. Researchers want to see if a certain     drug helps the immune system fight cancer cells. The drug is called pembrolizumab. It may     work even better with two chemotherapy drugs that are widely used to treat gastrointestinal     cancers.      Objective:      To study if pembrolizumab given with capecitabine and oxaliplatin (CAPOX) increases the time     it takes for a person's biliary tract cancer to get worse.      Eligibility:      People age 18 and older with previously treated biliary tract cancer that has spread to other     parts of the body      Design:      Participants will be screened with tests as part of their regular cancer care.      Each study cycle is 3 weeks.      For 6 cycles, participants will:      Get pembrolizumab and oxaliplatin on day 1 of each cycle. They will be given in an     intravenous (IV) catheter.      Take capecitabine by mouth for 2 weeks then have 1 week without it.      Participants will complete a patient diary.      Starting with cycle 7, participants will get only pembrolizumab. They will get it once every     3 weeks.      On day 1 of every cycle, participants will have:      Physical exam      Review of symptoms and how well they do normal activities      Blood tests      Every 9 weeks, they will have a scan.      Participants may have tumor samples taken.      Participants will have a final visit about 1 month after they stop the study drug. After     that, they will be contacted by phone or email yearly.   "
13271|NCT03111719|"     This study is focused on measuring mitochondrial activity of human brown adipose tissue.     During surgery, adipose tissue biopsies from white and brown adipose tissue will be collected     from the deep neck area. These biopsies will be used to examine mitochondrial function via     histological analysis, biochemical analysis and in vitro experiments based on precursor cells     present in the biopsies.   "
13276|NCT03111654|"     Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation     of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes     (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability.     Preventing the thromboembolic risk associated with FMD is therefore a public health issue.     The reference treatment is oral anticoagulation but this treatment is contraindicated in     patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle     is a recent technique which makes it possible to exclude this appendix from the left atrium     where the majority of thrombi are formed in the framework of the AF. Comparative studies have     shown the effectiveness of this technique, appearing to be similar to that of     anticoagulation. However, in view of the per-procedural risk, the indication of closure was     retained by the health authorities only in the event of a contraindication to oral     anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients     with a history of intracranial hemorrhage are therefore candidates for this technique, but     there are few studies where these patients were included. The risk-benefit must be     demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming     functional and cognitive.   "
13277|NCT03111641|"     Accurate pre-operative lung assessment is important to decide the most appropriate anesthesia     plan. Until now, chest X-ray is considered the standard of care for lung assessment during     perioperative evaluation. However, lung ultrasound is a rapid, simple, non-invasive,     radiation-free imaging modality and can be used as an alternative to chest radiography for     the diagnosis and follow-up of various lung diseases. Moreover, the decreased radiation     exposure represents a considerable improvement in patient safety. Consequently, we decided to     compare the data obtained from the lung ultrasound and the chest X-ray.   "
13371|NCT03110523|"     This is a Phase 3, Multicenter, Randomized, 20 Week, Double-Blind, Placebo Controlled and     32-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the     signs and symptoms of Subjects with Osteoarthritis of the Lumbar Spine. To evaluate the     efficacy of X0002 spray compared to placebo for the relief of low back pain disability in     subjects with osteoarthritis (OA) of the low back.   "
13279|NCT03111615|"     Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment     initiation varies from country to country and regionally within a country. Early diagnosis     and prompt treatment initiation are key factors in patient survival rates.      Currently there is a rising trend, with a high percentage of patients with Luminal like     breast cancer only undergoing adjuvant endocrine therapy.      Authors argue that tumor biology alterations after introducing very early endocrine therapy     might have a prognostic and therapeutic impact and should be studied.   "
13280|NCT03111602|"     INCREASE OF PROSTAGLANDIN E2 IN REVERSAL OF DUCTAL CONSTRICTION AFTER DIETARY RESTRICTION OF     POLYPHENOLS.      Clinical trial with a healthy group as comparator. The interventional group was made up of     third-trimester mothers whose single fetuses had ductal constriction, excluding those exposed     to NSAID, and the control group only by third-trimester normal fetuses. The interventional     group was submitted to dietary orientation to restrict polyphenol-rich foods and both groups     answered a food frequency questionnaire after fetal Doppler-echocardiographic examination and     blood draw for PGE2 levels analysis. After two weeks, the women were again submitted to fetal     echocardiogram, dietary assessment and blood draw.   "
13281|NCT03111589|"     Sickle cell disease (SCD) is an autosomal recessive disorder resulting from a substitution in     the β chain of hemoglobin (Hb) which causes hemoglobin S to polymerize when deoxygenated. SCD     patients present immune abnormalities that have always been attributed to functional     asplenia. It it is now being recognized that patients with SCD have a pro-inflammatory     condition with altered immune system activation contributing to the pathology of SCD.     Increased levels of neutrophils, monocytes or cytokines have been reported in SCD patients.      SCD is associated with many acute and chronic complications requiring immediate support.     Actual strongly recommended therapies include chronic blood transfusions (CT) and hydroxyurea     (HU). In addition, episodic transfusions are recommended and commonly used to manage many     acute SCD complications.There is strong evidence to support the use of HU in adults with 3 or     more severe vaso-occlusive crises during any 12-month period, with SCD pain or chronic     anemia, or with severe or recurrent episodes of acute chest syndrome. HU use is now also     common in children with SCD. Some patients receive chronic monthly RBC transfusion with the     objective to reduce the proportion of HbS to < 30 %. Long-term RBC transfusions prevent and     treat complications of SCD decreasing the risk of stroke and the incidence of acute chest     syndrome (ACS).      Therapeutic complications, such as alloimmunization against RBC in 20-50% of patients or     hematopoietic stem cell transplantation (HSCT) graft rejection, constitute an immune-based     clinical issue in SCD. Poorly understood RBC alloimmunization is responsible for serious     hemolytic transfusion reaction associated with severe mortality and morbidity underlying the     need for a better understanding of the immunology of SCD to improve SCD transfusion     support/outcome. Little evidence exists about HU effects on immune functions in SCD. HU     treatment doesn't appear to have deleterious effects on immune function and appears to     decrease the abnormally elevated number of total WBC and lymphocytes, while CT does not.      Patients with SCD are at higher risk of infections and prophylactic vaccination is strongly     recommended. Recent data suggest that vaccinal response to pneumococcal antigens in SCD     patients is identical to healthy control while controversy concern the stability of the     immune protection after vaccination of SCD patient. Antibody levels declined over the year     and the need for more frequent vaccination in SCD patient should be investigated. Currently,     there is no evidence whether HU may interfere with pneumococcal immune response. Purohit     showed that immune response to inactivated influenza A (H1N1) virus vaccine was altered in     patient with SCD receiving CT but little is known on immune response to vaccination in     patients with SCD receiving HU.      Recent data suggest that not only inflammatory status but also humoral immune response to     antigens in SCD patients may differ according to treatment. Yazdanbakhsh reported an     imbalance between regulatory T cell (Treg) and effector T cell (Teff) in alloimmunized SCD     patients with as consequence an increase in antibody production. In a model proposed by the     authors, the balance between Treg and Teff is dictated by the monocyte control of cytokines     expression. Altered activity of monocyte heme oxidase-1 (HO-1) would be responsible of a     decrease in IL-12 and an increase in IL-10 cytokines secretion impacting the Treg/Teff cells     ratio and promoting antibody production by B cells.      The objectives of the project are to assess whether different humoral immune responses to     vaccines or to erythrocyte alloantigens are related to the type of treatment administered to     patients with SCD. We also aim to study if these differences might be related to different     expressions of HO-1 by monocytes.   "
13282|NCT03111576|"     Normal pregnancy is associated with vasodilation and decreased peripheral resistance, which     is detected as early as 5 weeks' gestation .      Pre-eclampsia is a multi-system disorder of the second half of pregnancy , which is     characterized by increased vascular reactivity and peripheral resistance with pathological     changes that are consistent with impaired blood flow to the affected vascular beds.     Investigators will evaluate fetal and maternal vascular changes in normotensive and     pre-eclamptic patients by Ultrasound and Doppler and their impact on prediction of pregnancy     outcome.   "
13283|NCT03111563|"     The aim of the study is to compare the effectiveness of warm saline distension media versus     room temperature saline distension media on relieving pain in office hysteroscopy .   "
13284|NCT03110510|"     FOLFIRI as a salvage treatment in metastatic biliary tract cancer (BTC) patients who failed     gemcitabine containing chemotherapy   "
13285|NCT03110497|"     The purpose of the study is to evaluate safety and feasibility of single brachytherapy     application with dose delivery in multiple fractions. Study will be conducted in Phase I/II     clinical trial setting with strict Image guidance protocol.This study is expected reduce     treatment duration and to increase ease and acceptability of brachytherapy in patients along     with significant saving of resources   "
13286|NCT03110484|"     Pemetrexed in combination with erlotinib as a salvage treatment in patients with metastatic     biliary tract cancer (BTC) who failed gemcitabine containing chemotherapy   "
13287|NCT03110471|"     Lay Summary:      The investigators have shown in randomised controlled trials and observation studies that     structured nurse-led medicines' monitoring using the WWADR Profile benefits patients, for     example, by reducing pain and sedation and identifying high risk cardiovascular conditions.     The investigators now aim to understand what is needed to sustain implementation of the WWADR     Profile in routine practice and explore future directions.      The participants of the investigators previous research, 5 newly recruited care homes, and     stakeholders - care home managers, carers, healthcare professionals, and service users - will     be asked to contribute interviews, observations and reflective diaries/ accounts. The     investigators are interested in their experiences of medication use, medication management,     adverse effects and barriers and facilitators of medicine monitoring, and how electronic     devices can enhance nurse-led monitoring.   "
13288|NCT03110458|"     A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and     safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4     days in patients suffering from Acute Unilateral Vestibulopathy (AUV)   "
13289|NCT03110445|"     Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety     (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non     replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived     epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA     expressing tumors.   "
13292|NCT03110406|"     Introduction: Renal transplantation represents the therapeutic mode with more durable     treatment, greater cost-effectiveness, survival benefits and quality of life of the patients,     however, with high cardiovascular mortality.      Objectives: To evaluate the acute and chronic effects on heart rate variability and the     impact of chronic kidney disease on cardiorespiratory fitness in renal transplant recipients     following a full-body Vibration training program.      Methods: It will be a blinded randomized clinical trial (patient, evaluator and     statistician), controlled and endowed with secrecy of allocation, to be performed in the     Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal     University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology     outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the following     inclusion criteria: age between 18 and 59 years, who underwent transplantation at least one     year before and present a stable transplant function through the level Of creatinine   "
13293|NCT03111537|"     This is a multi-center trial involving the University of Minnesota, Ohio State University     Comprehensive Cancer Center, and Roswell Park Cancer. Cigarette smokers who are eligible will     be randomized to Snus, E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants     will enter a 1 week sampling phase. Smokers interested in continuing with the study after the     sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week     intervention. Tobacco use patterns, subjective responses to product, and nicotine and     toxicant exposure will be assessed.   "
13372|NCT03110393|"     The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical     i-gel® and Ambu®AuraGain™) in obese patients   "
13294|NCT03111524|"     Children who stutter (CWS) are at high risk of being teased and bullied in primary school     because of the negative peer attitudes and perceptions towards stuttering. Their experiences     can lead to long-term negative psychosocial consequences which can in turn affect academic     performance. There is little evidence to determine if classroom-based interventions are     effective in changing peer attitudes to stuttering. This study is designed to assess whether     a classroom-based CCR intervention versus usual practice in schools will lead to positive     shift in attitudes about stuttering at 6-months among grade 7 students.   "
13295|NCT03111511|"     The main purpose of this study is to evaluate the effect of steady-state concentrations of     JNJ-56136379 on the single-dose pharmacokinetics (PK) of drospirenone and ethinylestradiol     (oral contraceptive [OC]) in healthy female participants and to evaluate the effect of     steady-state concentrations of JNJ-56136379 on the single-dose PK of midazolam (sensitive     probe substrate for CYP3A4) in healthy female participants.   "
13296|NCT03111498|"     Training is very important for acquisition and maintenance of obstetric skills. As a     one-to-one practical teaching needs time and personal resources, the investigators want to     prove the benefit and necessity of the one-to-one training program compared to a theory-based     training program in conducting vacuum assisted deliveries (VAD).      The aim of this study is to prove that a practice-based training program (one-to- one     teaching) leads to better training results compared to a theory-based training program in     conducting VAD.   "
13297|NCT03111485|"     This trial will assess whether long-acting levodopa taken at night improves obstructive sleep     apnea (OSA) in patients with Parkinson's disease (PD), as compared with placebo.   "
13298|NCT03111472|"     This study will investigate whether it is possible, through the development and evaluation of     a self-management guide, to improve health related quality of life and concern of falling in     people with Parkinson's disease who fall, and reduce caregiver burden in their informal     caregivers.   "
13299|NCT03111459|"     The primary objective of the clinical investigation is to assess the use of the Medtronic     Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in     patients having appropriate anatomy. The primary intent of the study is to assess safety and     preliminary effectiveness of the device. Additionally, the study will assess technical     success and treatment success at each follow-up interval.   "
13300|NCT03111446|"     Anesthesia for caesarian section in patients with HELLP syndrome is a challenge. Measures     should be taken during caesarian delivery to guard against the maternal and fetal     complications associated with HELLP syndrome.   "
13301|NCT03111433|"     The purpose of this study is to determine wether coenzyme Q10 is effective in reducing     markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and     aslo to investigate its effect on glycemic control and lipid profile of those patients and     its effect on patient's quality of life.   "
13302|NCT03111420|"     Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet     dysfunction caused by P2Y12 inhibitor antiplatelet therapy. Study subjects will have     measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet     therapy.   "
13303|NCT03111407|"     The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to     radiographic, clinical and economic outcomes and compared to conventional instrumentation in     primary total knee arthroplasty (NexGen or Persona knee implants).   "
13304|NCT03111394|"     This is a pilot study looking at the feasibility of a mobile application (app) to collect     data from active tasks (questionnaires, 6Mapp™, COGapp™, VISapp™), clinical magnetic     resonance imaging information and conduct genome-wide association studies in subjects with     multiple sclerosis. Participants will be self-referred to this study from different sources;     patient advocacy groups, social media tools, clinicaltrials.gov, and flyers.   "
13305|NCT03111381|"     Double blinded randomized controlled clinical trial to assess the impact of intraoperative     Toradol on post-operative pain scores for patients undergoing ureteroscopy for urinary stone     management.   "
13306|NCT03111368|"     50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle     aspiration using two techniques: negative pressure and slow-pull. Cytological results will be     compared.   "
13307|NCT03111355|"     This study investigates the effect of genetic variations after supplementation with Brazil     nuts in healthy Brazilians. Briefly, all the participants will consume one nut a day for 2     months and will stop the intake for more 2 months. Five blood sampling collection will be     performed in one month interval, starting at baseline and ending at 2 months without     intervention.   "
13309|NCT03111329|"     The study aims to compare routine assessment of gastric residuals versus no assessment of     residuals in preterm neonates with respect to time taken for achieving full enteral feeding     and the incidence of possible complications, such as feeding intolerance, necrotizing     enterocolitis, sepsis etc.   "
13310|NCT03111316|"     In term women presenting for labor induction, combined use of the controlled release     dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median     time from induction to vaginal delivery by at least four hours compared to the Foley catheter     alone.   "
13311|NCT03111303|"     Hospital-acquired pneumonia (HAP) in patients in intensive care often requires the mechanical     ventilation (MV). Management and weaning from MV are given by specificity of this type of     pulmonary inflammation. Enrolled in the retrospective, observational study were all patients     older than 18 years staying at the ICU of University Hospital in Olomouc, between 1 January     2011 and 31 December 2016. The determination of the parameters of the MV, ICU length of stay,     hospital length of stay and mortality in HAP group were compared with the control group of     patients without HAP.   "
13546|NCT03108118|"     This study is designed to evaluate the relationship between diaphragm activity during     mechanical ventilation and the development of ventilator-induced diaphragm dysfunction     (VIDD). Diaphragm structure, activity, and function are monitored longitudinally over the     first 7 days of mechanical ventilation.   "
13547|NCT03108105|"     The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.   "
13312|NCT03111290|"     Purpose: To investigate whether rhythmic direct electrical stimulation (DES) causes     entrainment of endogenous neural oscillatory activity and whether such activity improve     cognition.      Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery cortical mapping     with continuous electrocorticography (ECoG) with intracranial electrodes.      Procedures (methods): Rhythmic electrical stimulation will be delivered via intracranial     electrodes during routine extra-operative cortical mapping. Long-term ECoG, Pre-stimulation     ECoG, peri-stimulation ECoG, and post-stimulation ECoG data will be analyzed to assess for     entrainment of neural oscillations.   "
13313|NCT03111277|"     Neuropathic pain is often a result of direct diseases of peripheral or central nervous system     with an estimated prevalence of 8% of adults and this pain is associated with significant     consequences because of longer symptom duration and severity than many of the other pain     syndromes. Functional brain imaging has revealed that many regions of the brain are engaged     by painful events, but specific areas such as the thalamus have been markedly implicated.      The purpose of this study is to determine the feasibility and safety of MRI-guided focused     ultrasound treatment using the ExAblate Transcranial System in patients suffering from     Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for     these patients.   "
13314|NCT03111264|"     Pediatric obesity, a defining health problem of the century, leads to long-term health     disparities. This application evaluates strategies to prevent health disparities early in     life by developing environmental wellness-related interventions focused on child-care center     staff and families.      Child-care centers provide an excellent opportunity to build healthy dietary and physical     activity lifestyle habits and avoid the rapid weight gain that leads to health disparities.     Building on a statewide survey among child-care centers and a pilot evaluation of an     environmental intervention, this 3-cell randomized trial evaluates the impact of a     staff-focused environmental wellness intervention and a staff and family-focused     intervention, against a control condition.   "
13315|NCT03111251|"     The purpose of the study is to determine the comparative effectiveness of a provider-only     intervention and a parent plus provider intervention to increase initiation of HPV     vaccination among male and female patients ages 11-17 in a large pediatric clinic network in     the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in     clinics randomized to the parent plus provider intervention compared with clinics randomized     to the provider-only intervention.   "
13316|NCT03111238|"     This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial     conducted in subjects with DM and CLI Rutherford Category 4. Minimisation will be used to     assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of     Rexmyelocel‑T or matching placebo into the index limb.   "
13317|NCT03111225|"     This study examines the prevalence of trigger points in muscles in the thorax in upper limb     Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we     will examine if adding treatment to muscles in the thoracic area (to the regular physical     therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.   "
13318|NCT03111212|"     The patients will be randomized into one of two groups. Both groups will receive standard     care as is state of the art. The intervention group will receive Iloprost nebulized as     inhalative therapy.   "
13319|NCT03111199|"     The purpose of this study is to analyze the effects of TENS Burst combined Cryotherapy on     painful sensation, functional capacity and quality of life of patients with non-specific     chronic pain.      Study hypothesis:      The TENS Burst combined with Cryotherapy offers a better response in the pain sensation,     functional capacity and quality of life of patients with non-specific chronic low back pain     when compared to the application of these resources in isolation.   "
13320|NCT03111186|"     This study is about pain control and medication following outpatient soft-tissue hand     surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and     satisfaction when compared with oxycodone alone.   "
13321|NCT03111173|"     This is a feasibility study for a new application for capturing fetal cardiac activity. The     objective of this study is to determine if it is feasible to capture a fetal ECG signal using     a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR)     device.   "
13364|NCT03110614|"     This is a prospective study to determine the relationships between pauci-inflammatory     exacerbations and diastolic dysfunction, and their implications in hospitalized patients with     acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a     number of comparisons will be made in subjects enrolled during acute exacerbation with     similar measurements made in the stable phase after recovery from exacerbation after at least     35 days from index hospitalization or prior exacerbation.   "
13365|NCT03110601|"     Trialing of PM modulation therapy in patients with chronic intractable low back pain   "
13322|NCT03111160|"     Small-incision lenticule extraction (SMILE), the most recently developed refractive surgical     technique, is being performed in a growing number of cases. This intrastromal keratomileusis     using only a femtosecond laser is a new procedure that extracts the refractive lenticule     through a small corneal incision ranging from 2 to 5 mm, with the absence of a flap and the     preservation of the anterior-most stromal lamellae and Bowman's layer (except for the region     of the small incision). Many studies have demonstrated that SMILE achieved comparable or     superior efficacy, safety, and predictability to femtosecond laser -assisted in situ     keratomileusis (FS-LASIK) and femtosecond lenticule extraction (FLEx). However, the recovery     of visual acuity in the early postoperative period after SMILE is slower, compared to other     refractive surgery techniques. Therefore, adjusting energy might improve postoperative visual     acuity and recovery time after SMILE. Nevertheless, the optimal parameters drawn from a     well-organized randomized study have yet to be elucidated. The purpose of this study was to     investigate the optimal femtosecond laser energy, with the aim of improving clinical outcomes     during the early postoperative period after SMILE for the correction of myopia. To this end,     we used a 500 kHz VisuMax with spot-spacing control at energy levels lower than 115 nJ, based     on the previous studies. Therefore, we prospectively compared visual outcomes of two groups     randomly divided by different laser energies: one underwent SMILE using lower energy levels     of 100, 105, and 110 nJ (L-SMILE), while the other group underwent SMILE at energy levels     conventionally used of 115 to 150 nJ (C-SMILE).   "
13323|NCT03111147|"     The proposed study is a prospective, single-blinded, randomized trial to investigate the     impact of humeral component version on shoulder range of motion and patient reported     functional outcomes following reverse total shoulder arthroplasty.   "
13548|NCT03108092|"     The objective of the health economic evaluation is to perform a state-of-the-art economic     analysis of the STRIP intervention, alongside the OPERAM Randomised Controlled Trial (RCT).   "
13549|NCT03108079|"     Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with     2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)   "
13324|NCT03111134|"     At present, open-type abdominal surgery is routine access into the abdomen. Median incision     is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used     at the end-time of the surgery. There are some common postoperative complications, such as     incision pain, surgical site infection, surgical incision dehiscence and incisional hernia.     The key to reduce the incidence of postoperative complications depends on safe and reliable     technology of abdomen-closing.      It's usually difficult to close the abdomen after the incisional hernia surgery, and the     recurrence of incisional hernia is high. But the recurrence fell off observably when     component separation technology was applied to abdomen-closing of incisional hernia.      Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine     abdominal surgery may improve the quality of wound-healing.      In this prospective single-blind randomized controlled trial, traditional abdomen-closing     technology and modified-CST will be used to gastric cancer surgery, and the quality of     wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.   "
13325|NCT03111121|"     Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce     the time to extubation after end of procedure   "
13326|NCT03111108|"     The purpose of this study was to evaluate the efficacy of each treatment arm using a fixed     dose combination (FDC) of EBR/GZR as assessed by the percentage of participants achieving     sustained virologic response, defined as HCV ribonucleic acid (RNA) <Lower Limit of     Quantitation (LLOQ) 12 weeks after the end of all study therapy (SVR12). This study also     evaluated the safety and tolerability of EBR/GZR.   "
13327|NCT03111095|"     The purpose of this study is to see if Honeywell Genesis Android Touch Bluetooth System     (mobile health) can improve patient satisfaction and quality of care provided to women     experiencing complications due to high blood pressure during pregnancy.   "
13328|NCT03111082|"     This prospective, observational study will assess 100 subjects in the post-anesthesia care     unit (PACU) at Parkland Hospital. Upon arrival to the PACU, patients' train-of-four (TOF)     ratio will be calculated using the StimPod NMS450 accelerometer to determine the presence of     any residual paralysis. Any patient with a TOF ratio < 0.9 will be reassessed every 10     minutes until the ratio is ≥0.90. The time it takes to reach a TOF ratio ≥0.9 will be     recorded. Subjects will be classified according to BMI categories: lean as <30 kg/m2, obese     as 30≤BMI≤39.9 kg/m2, and morbidly obese as BMI ≥40 kg/m2. This data will serve as a baseline     to assess the incidence of residual NMB that currently occurs in our PACU so that we may use     this pilot data to design future studies that aim to reduce the incidence of residual NMB.   "
13329|NCT03111069|"     The goal of this clinical research study is to find the highest tolerable dose of heated     doxorubicin that can be given to patients during surgery with abdominal tumors. The safety of     this drug will also be studied.   "
13330|NCT03111056|"     The goal of this study is to empirically evaluate a web-based intervention to reduce heavy     drinking among college women with a history of sexual assault who display elevated levels of     psychological distress. College women with a history of sexual assault often report more     heavy drinking and psychological distress than women without a history of assault. Moreover,     women with assault histories often have difficulty regulating their emotions and tolerating     distress which can lead to a pattern of drinking to cope distress. Trauma exposure, negative     mood, and poor coping strategies have been associated with poor treatment outcomes and     relapse following alcohol treatment. Incorporating distress tolerance and emotion regulation     skills with an alcohol intervention may enhance treatment effects among women with a history     of sexual assault by decreasing their motivation to drink to cope with depression or anxiety     and by building adaptive coping strategies. Therefore, the web-based intervention will     include cognitive behavioral skills for reducing alcohol consumption and incorporate emotion     regulation and distress tolerance skills from Dialectical Behavior Therapy.   "
13331|NCT03111043|"     Out-of-hospital arrest can occur from multiple etiologies. In patients without an obvious     reason for the sudden-death event, diagnostic evaluation is not clear. This study is to     determine if early imaging with a head-to-pelvis CT scan may improve diagnostic accuracy,     speed of diagnosis and potentially clinical outcomes.   "
13332|NCT03111030|"     This study will employ a multi-centre, randomized, wait-list controlled trial. A total of 30     participants (15 experimental, 15 wait-list control) between 18-65 years of age who have     chronic SCI ≥ 1 year prior will be recruited. Physical activity measures will be taken using     wrist-based accelerometers and the Physical Activity Recall Assessment for Persons with SCI.     Psychosocial factors will be evaluated through questionnaires. The primary health outcome     measure (aPWV), and secondary cardiovascular parameters will be assessed using a combination     of echocardiography and ultrasound. Fitness will be determined using a peak oxygen     consumption test on an arm-cycle ergometer. All measurement will be taken at baseline and     after 9 weeks following intervention commencement. Physical activity will also be sampled     mid-intervention at 4 and 7 weeks. For the wait-list control group, an additional measurement     time point will be added after they have received the intervention upon completion of the     control period. Training will involve weekly, 10-15 minute coaching sessions for 9 weeks. All     pre- and post-assessments will take place at the Blusson Spinal Cord Centre at ICORD or the     University of British Columbia Okanagan. Intervention content will be delivered over Skype or     phone, and the wrist- worn accelerometers will be delivered and picked up from the     participant's home during the intervention.   "
13333|NCT03111017|"     Heart failure with preserved ejection fraction (HFpEF) is the fastest growing form of heart     failure with a high morbidity and mortality rate, and is associated with severe exercise     intolerance. The mechanisms responsible for the reduced exercise tolerance remain poorly     understood. The investigators propose a novel paradigm shift, focusing on peripheral     limitations to exercise. In particular, the investigators will test the hypothesis that     muscle sympathetic nerve activity (MSNA) is elevated in older HFpEF patients compared to     healthy controls, and is associated with reduced exercise tolerance. The investigators will     also test whether 16-weeks of exercise training will lower MSNA compared to attention     control, and correlate with improved exercise tolerance in older HFpEF patients.   "
13334|NCT03111004|"     The study evaluates the impact of the new organisational models developed in the framework of     the BeyondSilos pilot service in order to provide ICT supported integrated health and social     care to elderly patients   "
13335|NCT03110991|"     Major depression is a common disorder among non-professional caregivers, and it can be     disabling and costly. Although there are effective psychological interventions to prevent     depression, most of them involve in-person treatment. New technologies have the potential to     overcome the barriers this format presents, which limit accessibility to such interventions.     The main objective of this project is to evaluate the effectiveness of a cognitive-behavioral     intervention in the prevention of depression, administered through a smartphone application     (App), both with and without telephone contact through multiconferencing. Secondary     objectives are: (a) test the moderating or mediating effect of the variables in the     theoretical model underlying the intervention; (b) analyze the variables that are predictors     of intervention outcomes; (c) analyze the acceptability and satisfaction with interventions.     A randomized controlled trial will be perform. Caregivers with clinically significant     depressive symptoms who do not meet the diagnostic criteria for depressive episode will be     included. Recruitment of 174 participants is planned, with random allocation to one of the     three conditions (58 participants per intervention): (a) a cognitive-behavioral intervention     administered via a smartphone App (CCIA); (b) a cognitive-behavioral intervention     administered via a smartphone App + telephone contact via conference call (CCIA+CC); (c)     attention control group (ACG). Both interventions will be administered in 5 modules via an     App for Smartphones and one group additionally will receive telephone contact via conference     call in group format during 4 sessions of 30 minutes. These phone sessions will be recorded     to assess the therapists adherence to the intervention protocols. All participants will be     evaluated at pre and posttreatment, and 1-, 3-, 6- and 12-month follow-up by trained     interviewers who will be blind to the aims of the study, the interventions employed, and the     group to which any given participant belongs. Incidence of depression will be examined as the     primary measure, with secondary measures being depressive symptoms, symptoms related to the     model (pleasant activities, negative thoughts and social contacts) and the acceptability of     and satisfaction with the intervention.   "
13336|NCT03110978|"     The goal of this clinical research study is to learn if adding nivolumab to standard     treatment (stereotactic ablative radiotherapy [SABR]) can help to control recurrent (has come     back) non-small cell lung cancer (NSCLC).   "
13337|NCT03110965|"     The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months     apart.   "
13338|NCT03110952|"     The potential synergistic effect of administering 2 dengue vaccine candidates that were     previously shown to be safe and immunogenic in humans will be evaluated in this study. A     prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with     the GSK AS03B adjuvant and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine     Formulation 17 (F17) will gather data to help better understand the human immune response to     dengue vaccination and infection.      This study is being done to evaluate the safety and immune reaction of administering one dose     of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine     compared to two doses of inactivated vaccine.   "
13339|NCT03110939|"     The goal of this clinical research study is to explore whether intrathoracic hyperthermic     perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung     cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after     surgery.   "
13340|NCT03110926|"     Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction     treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant     recurrence among patients with locally advanced esophageal cancer.   "
13341|NCT03110913|"     The research study is being done so we can determine the quality of the protein present in     Canadian lentils. Amino acids are the building blocks of protein and protein quality is     determined by the amount of amino acids present and by their bioavailability (their     absorption and use by the body). Some amino acids are essential which means they must be     obtained from the diet. If any one of the essential amino acids is missing in the diet, the     body cannot make proteins that are used to repair tissue build bone, teeth, etc… Lentils as a     food source contain low amounts of the essential amino acid methionine which makes its     protein incomplete. The amino acids in lentils are also affected by cooking. Our objective is     to determine the amount of methionine in lentils that the body can use. We will test lentils     by studying them after cooking them in a stew, on their own and by combining the lentil stew     with rice in a mixed meal to make a more complete protein.      This research is being done in order to bridge the gap between knowledge of protein     requirement and the amount of food needed to meet that requirement. Results from this study     will be important for recommendations guiding food choices of lentils as a major protein     source in the diet.      Previously the quality of dietary protein for human consumption was studied in animals. This     study is being done in humans because studies in animals are not directly applicable to     humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant     protein sources like lentils are important alternatives shown to enhance ecosystem     resilience, and improve human health.   "
13343|NCT03110887|"     Rationale: Approximately 10% of neonates admitted to neonatal intensive care units develop a     major hemorrhage. In an attempt to avert this severe complication various preventive measures     have been implemented. One of these is the transfusion of platelets to premature neonates     with low platelet counts. However, this practice is not supported by scientific evidence.     Most neonates with low platelet counts never experience a major bleeding and platelet     transfusions may carry risks of volume overload or infection. Therefore, it is important to     treat only those patients that truly benefit from this intervention. We urgently need a     scientifically based tool to predict which premature neonates are at risk for major bleeding.     A few prediction models do exist, but these only allow assessment of bleeding risk at     baseline, and do not correct for changes in clinical status during the admission period. We     believe that adding this feature to our prediction model will significantly improve our     ability to predict bleeding. The prediction model will also be helpful in developing     individualized transfusion guidelines as it helps us to predict which neonates would benefit     from prophylactic platelet transfusions.      Main objective: to develop a dynamic prediction model for bleeding in preterm neonates with     low platelet counts.      Study design: retrospective observational cohort study.      Study population: neonates with a gestational age at birth of < 34 weeks admitted to a     neonatal intensive care unit (NICU), with a thrombocyte count of less than 50x109/L will be     included.      Assessments: only data generated through standard care will be collected. This includes     platelet counts, cerebral ultrasounds, information about bleeding and transfusions, and     multiple clinical variables.      Main study endpoint: major bleeding during admission      Statistical analyses: dynamic prediction model using landmarking.   "
13344|NCT03110874|"     A multi-center, randomized, open, non-inferiority, Phase 4 study   "
13345|NCT03110861|"     The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients     with pulmonary valve dysfunction.   "
13373|NCT03110380|"     The primary objective of this study is to evaluate the efficacy of switching from a regimen     of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®;     F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed     dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus     DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral     (ARV) resistance as determined by the proportion of participants with human immunodeficiency     virus-1 ribonucleic acid (HIV-1 RNA) ≥ 50 copies/mL at Week 48   "
13346|NCT03110848|"     Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease     (GD), being observed in ~25% of patients. Besides genetic and demographical variables, risk     factors associated with the development of GO in GD patients are known to be inadequate     control of hyperthyroidism, radioiodine treatment, and smoking. In a large retrospective     study conducted in more than 8,000 individuals with GD it was observed that treatment with     3-hydroxy-3-methylglutaryl-coenzyme reductase inhibitors, better known as statins, is     associated with a ~40% reduced risk of developing GO in GD patients. The findings were     interpreted as the consequence of the anti-inflammatory action of statins, being GO     notoriously an autoimmune, inflammatory conditions.      Statins are widely used for the treatment of hypercholesterolemia, for which they are quite     effective. The possibility that their protective effect in terms of GO development in GD     patients, as observed by Stein et al., was simply due to their hypolipemic actions was not     considered. To evaluate the possibility that the findings reflected lowering of cholesterol     rather than a direct anti-inflammatory effect of statins a prospective, observational study     to assess the association between GO and high cholesterol levels and/or the relationship     between the degree and/or activity of GO and hypercholesterolemia is ongoing. Preliminary     findings suggest that GO is more severe and active in patients with high cholesterol levels.     On the basis of these observations, the present randomized clinical trial was designed to be     performed in hypercholesterolemic patients with GD and moderate-to-severe and active GO,     aimed at investigating if lowering of cholesterol levels with statins is associated with a     better outcome of GO.   "
13347|NCT03110835|"     Graves' orbitopathy (GO) is an autoimmune condition almost always associated with autoimmune     thyroid disease, especially Graves' disease (GD). According to the most widely accepted     model, the autoantigen/s responsible for GO would include molecules expressed by thyroid     epithelial cells that are present also in orbital tissues. The high likelihood that the     etiologies of GO and of the underlying autoimmune thyroid diseases are somehow linked is     confirmed by the very close relationship between GO, the onset and the course of Graves'     diseases, the size of the thyroid gland, and most importantly, thyroid function and thyroid     treatment. Based on these considerations, it has been proposed that complete removal of     thyroid antigens and of thyroid infiltrating lymphocytes, the so called total thyroid     ablation (TTA), may be followed by an attenuation of the immune reaction against orbital     antigens, and ultimately by an amelioration of GO. The possibility that TTA, achieved by near     total thyroidectomy followed by radioiodine, may be beneficial for GO was initially suggested     by two retrospective studies and more recently by two prospective, randomized clinical trials     conducted in patients with moderate GO treated with intravenous glucocorticoids. Although     there seemed to be no difference in the long term, compared with near total thyroidectomy     alone TTA was associated with a shorter time required for GO to improve, or anyway to reach     its best possible outcome, and with a lesser requirement for additional treatments in order     for GO to improve.      TTA is usually performed with a radioiodine dose of 30 millicurie (mCi), administered after 2     injections of recombinant human thyrotropin TSH (rhTSH), the latter in order to induce     radioiodine uptake by thyroid remnants. According to the Italian legislation the     administration of such a dose of radioiodine must be followed by a 24 hours protected     hospitalization. Clearly, this necessity implies a remarkable increase of the waiting list,     due to the limited number of radiation-isolated beds available and, concerning GO patients,     to the competition with patients with thyroid cancer. In contrast, a radioiodine dose of 15     mCi can be performed in out-patients without hospitalization and with much lower costs.     Concerning GD patients, they usually have serum TSH-receptor stimulating antibodies that ay     persist after thyroidectomy and that may increase radioiodine uptake along with rhTSH,     possibly resulting in the need for a lower dose of radioiodine to ablate thyroid remnants. In     order to investigate whether this is the case, the present study was designed in patients     with GD. The study design was to include patients scheduled to radioiodine treatment with 30     or 15 mCi after administration of rhTSH, being the primary outcome the values of serum     thyroglobulin at peak after administration of rhTSH 6 months after radioiodine, as a measure     of the presence of residual thyroid tissue.   "
13348|NCT03110822|"     This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of     ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive     disease.   "
13349|NCT03110809|"     This research study is being done to determine whether taking a dietary supplement called     capsinoids, derived from sweet peppers, can activate brown fat that is already present or     even generate new brown fat in individuals with excess weight. Previous studies have     suggested that chronic consumption of capsinoids may be able to generate new brown fat in     thin individuals. Capsinoids may also have a small positive effect on metabolism (increased     calorie-burning) and fat loss. The knowledge gained in this study may eventually lead to more     treatment options for people with excess weight.   "
13350|NCT03110796|"     Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same     device, free of LU3103209 compound, in the local management of DFUs.   "
13366|NCT03110588|"     This trial is being conducted to determine the feasibility and recommended dose of the     combination of four drugs (prednisone, abiraterone, cabazitaxel and enzalutamide (PACE) as     first-line therapy for metastatic castration-resistant prostate cancer (mCRPC).   "
13827|NCT03104452|"     The purpose of this study is to learn how women's smoking changes during their pregnancy and     as a new mom, and to assess the help they receive from their health care providers.   "
13351|NCT03110783|"     This is a randomized, single blinded, multi-center controlled study evaluating the     effectiveness of Bioseal as an adjunct to sutured dural closure compared to control to obtain     an intra-operative watertight dural closure. Subjects will undergo an elective posterior     fossa or supratentorial procedure (craniectomy or craniotomy). Upon completion of the sutured     dural repair, the closure will be evaluated for intra-operative CSF leakage with a baseline     Valsalva maneuver to 10-20 cm H2O for 5-10 seconds. If a spontaneous leak is apparent     immediately after dural closure, no Valsalva will be performed. Subjects who have a CSF leak     will be enrolled into the study.Subjects will be stratified by surgical procedure: posterior     fossa or supratentorial and subjects will be randomized to either Bioseal or to suture     (control) in a 2:1 allocation ratio. For subjects randomized to receive Bioseal, a thin layer     will be applied to the entire length of the suture line and the adjacent area to     approximately 5mm away, including all suture holes. Up to two layers of Bioseal may be used     for each application. While Bioseal achieves complete coagulation, CSF leakage will be     re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds. Up to two     applications (one application includes applying up to two layers of Bioseal product followed     by the CSF leakage re-evaluation with Valsalva maneuver) per subject are allowed. Closure of     the remaining layers of the surgical site will be performed according to the surgeon's     standard of practice.Subjects randomized to control will receive additional dural sutures as     deemed necessary by the surgeon. CSF leakage will be re-evaluated with the Valsalva maneuver     to 10-20 cm H2O for 5 to 10 seconds. Closure of the remaining layers of the surgical site     will be performed according to the surgeon's standard of practice.If watertight closure is     not evident after the final Valsalva maneuver for either randomized group, the subject will     be deemed a failure and surgeons may revert to their standard of care for closure. The     incidence of CSF leaks will be assessed up to post-operatively 30 days. Post-operative CSF     leak or pseudomeningocele is confirmed by clinical examination, imaging or diagnostic     testing, or by relevant laboratory testing. Subjects at least 18 years of age undergoing     elective craniotomy/ craniectomy surgery for pathological processes (such as benign and     malignant tumors, vascular malformations) in the posterior fossa or supratentorial     procedures. Subjects will be screened and selected from the patient population of     approximately 7 clinical sites within the China.Proportion of success (watertight closure) in     the treatment of intra-operative CSF leakage. Success is defined as no CSF leakage from dural     repair intra-operatively, after final Valsalva maneuver up to 10-20 cm H2O for 5 to 10     seconds. Study hypothesis is to confirm that the proportion of successes in Bioseal group is     greater than the proportion of successes in control group.   "
13353|NCT03110757|"     The study will be conducted as a randomized, controlled, double blind Phase 1b     dose-escalating clinical trial in up to 60 healthy adult males and non-pregnant females     living in the S. mansoni-endemic area of Americaninhas, Brazil. The primary objective of this     trial is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel®     (10mcg, 30mcg, or 100mcg) vaccine with or without AP 10-701 given as three doses administered     on Days 1, 57, and 113.   "
13550|NCT03108066|"     The primary objective of this study is to assess the overall response rate (ORR) of von     Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL     patients treated with PT2385.   "
13354|NCT03110744|"     In chordoma cell lines and patient biopsies, the p16 (CDKN2A) tumor suppressor is     consistently deleted. Thus, chordomas are an example of a tumor with universal activation of     the cyclin-dependent kinases 4 and 6 (CDK4/6) pathway, and experiments with patient-derived     chordoma cell lines demonstrate aberrant CDK4/6 activity downstream of p16 loss can be     efficiently inhibited by the CDK4/6 inhibitor palbociclib, resulting in reduced proliferation     and growth of neoplastic cells. The investigators aim to conduct a phase II clinical trial to     evaluate the efficacy of the small-molecule CDK4/6 inhibitor palbociclib in patients with     locally advanced/metastatic chordoma who are not candidates for standard therapy. The primary     objective is disease control in patients with chordoma treated with palbociclib as single     agent. The study design of this phase II study is based on a Simon two-stage design.   "
13355|NCT03110731|"     The aim of this study was to analyze the effects of strength training on sleep quality and     daytime sleepiness in institutionalized adolescents (14 to 19 years of age). Thirty-one     adolescents were randomly assigned in two sample groups: intervention group (IG, n = 19) and     control group (CG, n = 12). Anthropometric measures were performed (height and body mass) and     BMI was determined. Sleep quality and daytime sleepiness were assessed using the     questionnaires, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESE), and     total sleep time by accelerometer. Physical training (2x / week) was performed for 12 weeks.     The OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES) scale was used to     control the effort intensity and the exercises followed an alternate pre-follow-up.   "
13356|NCT03110718|"     Muscle vibration (MV) has been suggested as a useful non-pharmacological approach to control     spasticity. Armeo Power® (AP) is a robotic exoskeleton for rehabilitation allowing early     rehabilitation treatment. The objective of our study was to determine whether AP training     coupled with MV applied on antagonist muscles of the spastic upper limb (UL) can reduce the     spasticity of agonist muscles. We enrolled 20 chronic post-stroke patients, who underwent 40     daily sessions of AP training. Ten subjects (group-A) received muscle MV (on triceps brachii,     deltoid, and supraspinatus), whereas the other 10 (group-B) underwent a sham vibration.   "
13357|NCT03110705|"     Within the components of Scuba diving there are similarities with meditation and mindfulness     techniques. Perceived stress is known to be diminished during meditation practice. This study     evaluates the benefits of scuba diving on perceived stress and mindful functioning.   "
13358|NCT03110692|"     The goal of this study is to reduce preference sensitive, unnecessary daily imaging during     radiation treatment in which a pre-planned quality improvement default option for radiation     treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology.   "
13359|NCT03110679|"     OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the     Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.   "
13360|NCT03110666|"     This pilot study will evaluate the clinica! and radiological results of a treatment for knee     osteoarthritis with injections of autologous concentrated bone marrow aspirate at the     bone-cartilage interface via percutaneous.   "
13361|NCT03110653|"     Modern anesthesia has made a lot of progress, however, postoperative pain remains one of the     major problems associated with patient discomfort, prolonged hospital stay and increased     health care costs.      Remifentanil is an ultra-short-acting phenylpiperidine opioid analgesic with high lipid     solubility and a rapid onset of effect.      Recently, opioid use has also been associated with postoperative opioid-induced hyperalgesia     or acute opioid tolerance. An immediate discontinuation of remifentanil has been associated     to increased postoperative pain levels.      We would like to investigate whether a gradual post-operative withdrawal of remifentanil is     indeed associated with less immediate pain compared to after an abrupt withdrawal in surgical     patients undergoing minor surgery.   "
13362|NCT03110640|"     This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells     infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment     potential in patients with CD19+ B-lineage leukemia and lymphoma.   "
13363|NCT03110627|"     This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on     the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard     indications.   "
13368|NCT03110562|"     This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study     will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety     of selinexor plus bortezomib (Velcade® or generic equivalent) plus low-dose dexamethasone     (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have     received 1 to 3 prior anti-multiple myeloma (MM) regimens. After progressive disease (PD),     patients in the Vd Arm may cross over to SVd treatment. Patients who cross over will be     referred to as SVdX patients.   "
13369|NCT03110549|"     The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single     dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and     intramuscular TMB-607 administered to HIV-negative volunteers.   "
13370|NCT03110536|"     Assessment of burnout syndrome of triage nurses from Emergency Departments from Cluj-Napoca,     Romania.   "
13374|NCT03110367|"     Pain is a common experience in youth and influences youth long after the painful situations     are over. Youth memory of pain after surgery can affect painful experiences in the future.     Negative memories and feelings of pain, like remembering more pain than the actual level of     pain experienced are linked to anxiety for future surgery. Research has found that children's     memories of pain is linked to anxiety, pain-related fear, and confidence. Children's memories     for pain can be altered after a visit to the hospital, but only a couple of studies have look     at this.      The study will be one of the first to look at how well a parent-led memory reframing     intervention to reduce youth's negative memories of surgery. We want to look at how a     parent-led memory reframing session on youth's post-surgical pain memory.      The study will include 90 youth who have a chest wall surgery or a spinal fusion surgery at     the Alberta Children's Hospital. They will be recruited at the Alberta Children's Hospital.     There will be pain tests in the form of surveys 1-3 weeks before surgery, pain monitoring in     the hospital for a couple of days, pain monitoring 1-2 weeks after surgery, a clinic visit     2-4 weeks after surgery for a memory reframing session, and pain monitoring 6 weeks after     surgery in the form of a telephone interview.   "
13375|NCT03110354|"     This research study tests an investigational drug called DS-3201b. An investigational drug is     a medication that is still being studied and has not yet been approved by the United States     Food and Drug Administration (FDA). The FDA allows DS-3201b to be used only in research. It     is not known if DS-3201b will work or not.      This study consists of two parts. The first part (Part 1) is a dose escalation that will     enroll subjects with AML or ALL that did not respond or no longer respond to previous     standard therapy. The purpose of Part 1 of this research study is to determine the highest     dose a patient can tolerate or recommended dose of DS-3201b that can be given to subjects     with AML or ALL. Once the highest tolerable dose is determined, additional subjects will be     enrolled at that dose into Part 2 of the study.   "
13376|NCT03110341|"     Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and     long-term neurodevelopmental delay. Magnetic resonance imaging (MRI) allows the     characterization of specific features of encephalopathy of prematurity, including structural     changes of brain white matter and gray matter. This study wants to investigate important     evidence that early repeated high-dose rhEPO(5250 IU/kg) treatment improves long-term     neurological outcomes in very preterm infants and without obvious adverse effects.   "
13377|NCT03110328|"     eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for     pembrolizumab. Treatment with pembrolizumab will continue until documented disease     progression, unacceptable adverse event(s),intercurrent illness that prevents further     administration of treatment, Investigator's decision to withdraw the subject, subject     withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure     requirements, subject receives 24 months of pembrolizumab, or administrative reasons     requiring cessation of treatment.   "
13378|NCT03110315|"     This study assesses the safety, tolerability, and efficacy of suvorexant in multiple     sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment     period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects     will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either     suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater     improvement in sleep, as measured by symptom rating scales, compared to placebo.   "
13379|NCT03110302|"     This study will provide a certain type of exposure therapy, called prolonged exposure therapy     (PE), to military Veterans with Post Traumatic Stress Disorder (PTSD). One hundred and     seventy-five Veterans will participate in the study. The main study goal is to compare PE     conducted in three different ways: (1) PE that is office-based (OB; Veterans come to a VA     clinic and meet with a therapist via telehealth, using videoconferencing technology), (2) PE     delivered via home-based telehealth (HBT; Veterans stay at home and meet with the therapist     via telehealth, using videoconferencing technology), and (3) PE delivered in home, in person     (IHIP; the therapist goes to the Veterans' homes to provide the psychotherapy). Symptoms of     PTSD, depression, and anxiety will be examined at pre-treatment, post-treatment and at     six-month follow up to determine if symptoms change over time. Study hypotheses state that     the IHIP approach, compared to the other two approaches, will be more effective at reducing     the PTSD symptoms experienced by these Veterans because it will help Veterans attend each     session and complete the therapy homework assigned by the therapists (such as doing feared,     but safe, activities around the house or the neighborhood). However, the delivery of IHIP may     cost more than the delivery of PE via the other modalities.   "
13388|NCT03110185|"     Postoperative delirium - a mental state of confusion, inattention, and impaired thought - is     a potentially life-threatening condition. As many as half of patients that have heart and non     heart-related surgery will experience postoperative delirium. Patients diagnosed with     postoperative delirium have poorer outcomes and longer hospitalizations. Unfortunately, it is     an under-diagnosed condition with a variable delay in when it appears. Additionally, there     are no objective tools or tests that can be before or after surgery to anticipate and     identify those patients who are at risk. Electroencephalography [EEG] and functional magnetic     resonance imaging [fMRI] have helped us understand the changes in the brain during delirium.     These suggest that a weakening in correlated activity within a group of brain regions, known     as the default mode network (DMN), may be related to delirium.   "
13380|NCT03110289|"     The AIM of this study is to investigate whether the FMT success rate in active UC patients     can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by     repeated FMT.      The investigators will start a national multi-centre double-blind randomized sham-controlled     trial in April 2017 at 6 hospitals in Belgium and 2 in The Netherlands. They will randomly     allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score     2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor'     faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham).     Each patient will receive 4 FMT's. At baseline FMT will be performed during sigmoidoscopy. At     week 1, 2 and 3, the FMT will be administered through rectal instillation. Each FMT will be     derived from one donor. Donors will be pre-selected based on a species richness and abundance     of taxa of interest. The primary outcome will be steroid-free clinical and endoscopic     remission at week 8 (Mayo score ≤2, all subscores ≤ 1, and ≥1 point reduction in endoscopy     subscore). Fecal, blood and mucosal samples and questionnaires will be collected at different     time points. 16S rRNA stool analysis will be performed to assess the microbial changes after     FMT.   "
13381|NCT03110276|"     The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids     pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of     hepatitis B.      This Phase 1 study is designed primarily to evaluate the single ascending dose (SAD) followed     by a multiple ascending dose (MAD) safety, tolerability, and pharmacokinetics of EYP001a in     healthy male subjects.   "
13392|NCT03110133|"     This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the     Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects     with Recurrence of Clostridium difficile Infection   "
13382|NCT03110263|"     In this study, people who suffer from insomnia will be randomized to one of three study     conditions. The first group receives a multicomponent internet-based cognitive behavioral     self-help intervention. The second group has access to an internet-based self-help sleep     restriction intervention. The third group is a waiting control group. In both active     conditions additional care or treatment is allowed. The aim of the study is to investigate     the effectiveness of a multicomponent internet-based cognitive behavioral self-help     intervention as well as a stand-alone internet-based self-help sleep restriction intervention     for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and     8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control     group get access to the internet-based cognitive behavioural self-help intervention and also     fill out questionnaires at 6-months post-randomization.   "
13383|NCT03110250|"     A-HIT2, is also designed as a National FH registry. At least 1000 FH patients will be     recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey     proportional to the 2015 Turkey's Population distribution.[14] Both HeFH and HoFH patients     are eligible for enrollment. Sites specialized on cardiology, internal medicine, and     endocrinology were invited by the Turkish Society of Cardiology.   "
13384|NCT03110237|"     Many survivors of acquired brain injury (ABI) suffer from decreased balance and increased     risks of falls. Previous studies indicate that balance training improves balance, reduces     falls, and increases walking speed and balance confidence. The purpose of this study is to     determine if a multidimensional balance training based on the FallProof(TM) approach achieves     better improvements in balance and walking performance than the current practice .     Participants will be assigned to: 1)a task-oriented circuit training balance class (current     practice), or 2) balance training class based on the FallProof(TM) approach. Standardized     tests will determine if participating in balance training helps improve balance, walking     speed and balance confidence.   "
13386|NCT03110211|"     Purpose and Objective: To determine the effectiveness of a physical therapist first versus a     primary care physician first for patients entering a primary care setting with a     musculoskeletal complaint on the outcomes of costs/charges, utilization and healthcare     satisfaction.      Study activities and population group: This will be a randomized clinical trial enrolling     patients who are seeking care to the Duke Outpatient Clinic with a musculoskeletal complaint.     Patients, adults aged 18 years or greater, that agree to be part of the study will be     randomized to see a physical therapist first or primary care physician first. All aspects of     the evaluation and treatment by both providers will be standard care for musculoskeletal     conditions.      Data analysis and risk/safety issues: Descriptive data including means and standard     deviations and counts and proportions of baseline scores will be conducted. Differences in     total costs/charges, opioid prescriptions, emergency department visits will be calculated and     tested across groups. Participants may not personally be helped by taking part in this study.     Participants may experience improvements in pain, function, or other symptoms from physical     therapy program in this study. There is a minimal risk of loss of confidentiality. If a     patient chooses not to participate, there will be no effect on their medical treatment and     the study team will cease contact.   "
13387|NCT03110198|"     The research aims to evaluate the efficacy and safety of that mesalazine with hydrocortisone     sodium succinate for the induction of clinical remission during a 4-week double-blind     treatment period in active UC (define as total Mayo score of greater than or equal to 4 and     less than or equal to 10). A total of 528 patients will be randomly divided into three group,     one will receive mesalazine 4g with hydrocortisone sodium succinate 100mg enema, and the     other two group will respectively to receive mesalazine 4g and hydrocortisone sodium 100mg     one times daily for 4 weeks. The end of the study for every patient is the improvement of     main symptoms.The primary endpoint is the clinical remission after 2 and 4 weeks double-blind     treatment, defined on the basis of a total Mayo score ≤ 2 points, with no subscore > 1 point.     The secondary endpoint are endoscopic mucosal healing at week 2 and 4 of double-blind period,     defined as an absolute subscore for endoscopy portion of the Mayo score of 0 point and the     change from baseline in Quality of Life at week 4 of double-blind period based on the IBDQ.   "
13389|NCT03110172|"     By taking certain antidepressant in early postoperative period，which is supposed to improve     the psychological status of patients with osteoarthritis, explore the effect of certain     antidepressant on the recovery of the early stage after the operation of knee joint     replacement.   "
18274|NCT03046342|"     Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending on     the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE in     Pediatric population of Qatar   "
13390|NCT03110159|"     This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy     of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination     using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT).      The study hypothesis is that post solid organ transplantation patients, highly susceptible to     non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic     application of PDT, lessening morbidity and possible mortality for this immunosuppressed     patient population.   "
13391|NCT03110146|"     The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking     algorithms within the Velocity Research Platform (VRP) by assessing the frequency of     shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1      The secondary objective is to evaluate catheter rendering in the VRP system.   "
13397|NCT03110068|"     Presence of microvascular invasion can be estimated preoperatively, by some clinical imaging     features such as patient characteristics, serum biomarkers and radiological features.     Contrast-enhanced ultrasonography (CEUS) and contrast-enhanced computed tomography (CECT) are     routine preoperative conventional examinations for hepatocellular carcinoma (HCC) patients in     China. Combining features of CEUS, CECT and clinical factors may improve preoperative MVI     assessment. The purpose of this study is to construct a nomogram for preoperative MVI risk     estimation with these possible factors.   "
13398|NCT03110055|"     Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause     of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying     cause of cirrhosis and HCC in the western world. Most patients with HCC present with either     non-resectable tumor and/or severe underlying liver dysfunction, and are not suitable     candidates for curative treatments by resection or transplantation. Thus, for the majority of     patients with HCV related HCC, the only option is prolongation of life without a chance for     cure. These patients generally have a poor prognosis with a median survival of less than 1     year. Arterial obstruction of branches of the hepatic artery and simultaneous infusion of     chemotherapy (Trans-arterial chemo-embolization or TACE) induces ischemic tumor necrosis with     a high rate of objective tumor responses (30-60%). Overall, the median survival after TACE     for intermediate HCC is about 20 months, an improvement over supportive care. Treatment with     Grazoprevir/Elbasvir showed excellent results in phase 3 studies for patients with HCV     genotype 1 (a and b) and genotype 4 infection and is approved for HCV treatment in the USA,     Europe and Israel. Anti-HCV therapies may influence HCC biology by decreasing inflammation     and may thus alter the tumor microenvironment.   "
13399|NCT03110042|"     The HILO-HF Registry is a single centre registry that will be performed to provide     information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with     a primary ED diagnosis of AHF   "
13400|NCT03110029|"     This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal     infections in patients who wear polish compared to those who do not.   "
13401|NCT03110016|"     The study aimed to examine the feasibility, usability, user satisfaction, safety, and     preliminary efficacy of a smartphone application intervention for young adults with     subthreshold depression.   "
13402|NCT03110003|"     In this study the investigator will address the efficacy of using low dose bupivacaine spinal     anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing     short obstetric procedures.   "
13403|NCT03109990|"     Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery.     Previous studies in cells and animals show that dexmedetomidine may promote cancer growth.     The purpose of present study is to examine whether utilization of dexmedetomidine in patients     undergoing surgery for primary breast cancer increases breast cancer recurrence and     metastasis, and to investigate its effects on the patients' immune system.   "
13404|NCT03109977|"     The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds     HER2 proteins can be used to take pictures of HER2-positive cancer.   "
13405|NCT03109964|"     Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly     divided into 2 groups according to intervention technique-half will be allocated to the     bipolar coagulation group and half to the SURGIFLO group.      Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests     including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2),     Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian     volume and antral follicle count.   "
13406|NCT03109951|"     Type 2 diabetes is rapidly increasing globally and has been associated with an increased risk     of colorectal cancer. Therefore, the numbers of diabetic patients who will undergo     colonoscopic screening are expected to grow exponentially. Colonoscopic preparation entails     prolonged fasting, cessation of anti-diabetic medication and ingestion of preparation     medications. This may put the diabetic patient at risk of potentially dangerous hypo- or     hyperglycemia. However, studies regarding the safety of colonoscopic preparation in diabetic     are lacking. In this study, the investigators aim to discover the prevalence of abnormal     glucose levels in diabetic patients who undergo colonoscopy. The investigators also aim to     find out risk factors for abnormal glucose levels and develop a safe preparation protocol.   "
13407|NCT03109938|"     Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important     in guiding the treatment strategy. The use of advanced imaging is not standard clinical     practice in China. A clinical trial is now under way comparing the accuracy of narrow band     imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the     diagnosis of LST with submucosal invasion.   "
13408|NCT03109925|"     This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of     lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will     allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a     better understanding of embolic distribution.   "
13432|NCT03109613|"     Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical     ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion     mismatch is present, areas of the lung that are open for gas exchange do not match up with     areas of the lung that are receiving blood for gas exchange. This study measures the     feasibility of enrolling and completing study maneuvers in premature infants for a     prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or     level) of PEEP.   "
13418|NCT03109795|"     The goal of this study is to evaluate the effectiveness of a short-term (4 weeks)     pharmacological blockade of sympathetic nerve activity (clonidine) on anxiety symptoms,     vascular function, inflammation, muscle sympathetic nerve activity, and oxidant stress in     individuals with moderate-to-high anxiety. Individuals who are interested in the study will     be identified by an online screening survey and will be contacted by the research team;     advertisements, flyers and mass emails will direct individuals to the online screening     survey. Those deemed eligible to participate will be randomized to either the clonidine     intervention or hydrochlorothiazide as a blood-pressure lowering control condition. If     eligible participants are currently being treated with blood pressure-lowering medications,     they will be asked to go off these medications for 2 weeks prior to and during the course of     the study. During the 2 week washout of blood pressure-lowering medications, participants     will have safety visits (2 additional visits) that include measurements of blood pressure at     4 days and 7 days after the beginning of the washout period before the intervention.     Assessments of anxiety symptoms via various surveys, vascular function (via non-invasive,     well-established techniques), inflammation, muscle sympathetic nerve activity, and oxidant     stress will be performed at baseline and at the post intervention session. Similar baseline     measurements will be performed in control subjects with low or no anxiety for comparison, but     these individuals will not undergo the intervention.      Participants with moderate-to-high anxiety will have a total of 6 visits to the laboratory,     which includes the screening and consent (visit 1). Visit 2 (baseline measurements) and visit     6 (post-intervention measurements) will be more extensive (~4.5 hours) compared to the other     visits (~30 min). Participants completing the washout will have an additional 2 visits (~30     min each) before visit 2. Control subjects with low or no anxiety will only participate in     visit 1 (screening and consent ) and visit 2 (baseline measurements).   "
15756|NCT03079245|"     To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall     and inappropriate antimicrobial use in the neonatal intensive care unit (NICU), a pre-post     study was performed in 4 NICUs.   "
13409|NCT03109912|"     Physical activity (PA) in individuals with cystic fibrosis (CF) improves exercise capacity,     slows decline in lung function, increases mucus clearance and improves health-related quality     of life (HRQoL). Establishing and maintaining an exercise routine remains challenging and     programs promoting PA in people with CF have poor participation. Moreover, while the positive     effects of physical conditioning on lung function have been well reported, conventional     measurements of lung function may lack the sensitivity to reveal improvement in mild lung     disease.      This randomized control trial (RCT; N = 60) evaluates the Do More, B'More, Live Fit, a     6-month fitness program designed to optimize exercise habits of 12-21 year-olds with CF     through structured exercises with personalized coaching, exercise equipment including the     FitBit Flex, online support and motivational messages delivered electronically. The     intervention incorporates fitness preferences and encompasses endurance, strength and     flexibility exercises while adjusting to physical fitness needs. The hypothesis is that     intervention participants will have increased and sustained engagement and better health     outcomes compared to control group participants. The investigators' specific aims are to:        1. Increase daily PA and measures of fitness        2. Improve lung clearance index (LCI) and participant HRQoL        3. Demonstrate feasibility, accessibility and satisfaction of intervention using          semi-structured interviews      The results of this pilot evaluation of the Do More, B'More, Live Fit program will offer     novel insight into factors that sustain engagement in exercise programs and identify if LCI     is an appropriate clinical outcome to assess PA interventions. Results will inform future RCT     of interventions to optimize exercise habits of adolescents with CF.   "
13410|NCT03109899|"     The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use     among young Black men who have sex with men (MSM), and testing a novel mobile app to increase     HIV/STI testing and PrEP uptake.   "
13412|NCT03109873|"     This pilot clinical trial studies how well metformin hydrochloride works in affecting     cytokines and exosomes in patients with head and neck cancer. Metformin hydrochloride may     reduce the metabolic activity of cancer cells and of surrounding supportive tissues.   "
13413|NCT03109860|"     The study investigates the effect of an open (in full view of the patient) vs hidden     treatment (without the patient's knowledge).   "
13414|NCT03109847|"     This pilot clinical trial studies how will metformin hydrochloride works in mitigating the     side effects of radioactive iodine treatment in patients with differentiated thyroid cancer.     Metformin hydrochloride may reduce the metabolic activity of cancer cell and of surrounding     supportive tissues.   "
13415|NCT03109834|"     Aim of this prospective randomized study was to evaluate whether a diet with meal     replacements can be as effective as a conventional energy-restricted modified diet on weight     loss, body composition and cardiometabolic risk profile in overweight women. Moreover, the     impact of these two different weight management strategies was observed on cardiometabolic     risk profile after a self-directed weight stabilization phase following the weight loss     phase. After that, the effect of a specific micronutrient composition with omega-3 fatty     acids versus placebo on cardiometabolic risk was observed during a following phase of weight     loss maintenance.   "
13416|NCT03109821|"     In this study we will investigate the relation between performed exercise dose and recovery     after total hip replacement (THA). A dose-response relationship is hypothesized.      It is the primary objective to indicate the preliminary efficacy of home-based rehabilitation     using elastic band exercise on performance-based function after THA, based on the     relationship between the performed exercise dose (objectively quantified time under tension     summary dose) and the change in 40 meter maximal gait speed (performance-based function) from     3 (start of intervention) to 10 weeks (end of intervention) after surgery.   "
13417|NCT03109808|"     Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the     use of a personalized oral hygiene video, made available to the patient via a cloud-based     system, in conjunction with a text-based two-way recall system will increase patient     compliance, hence leading to improvement or oral hygiene.   "
13431|NCT03109626|"     The project will study a therapeutic approach in Spinocerebellar Ataxia (SCA38) by DHA     replacement. SCA38 is caused by missense mutations in the ELOVL5 (Elongation of very long     chain fatty acids protein 5) gene.      Background/Rationale: ELOVL5 is a microsomal fatty acid elongase gene required for the     synthesis of arachidonic acid and DHA. In brain, it shows a peculiar high expression in     cerebellar Purkinje cells.      The ELOVL5 products, such as DHA, are decreased in SCA38 patients serum and DHA administered     as a dietary supplement has been shown to improve SARA scores, to ameliorate quality of life,     and to increase brain cerebellar hypometabolism (FDG-PET) in two SCA38 patients.      Experimental Plan: The investigators will perform a randomized placebo-controlled trial by     DHA supplementation on ten SCA38 patients, followed by an open-label phase.      Expected results: DHA supplementation should be able to improve symptoms in SCA38 and to     improve cerebellar hypometabolism in these patients.   "
13433|NCT03109600|"     This study is to assess the safety of Vi-DT vaccine in adults and children.   "
13419|NCT03109782|"     Traumatic spinal cord injury (tSCI) is a debilitating disease that leads to neurological     deficits and often has long-term effects including severe lifelong disability. Given the     devastating personal and economic consequences of SCI, it is critical to collect     high-quality, prospective data. SCI has not been systemically assessed in Austria, and data     regarding the etiology, incidence and prevalence are missing or significantly limited. More     importantly to the individuals suffering from SCI, health care for SCI patients in Austria is     not concentrated in specialized SCI centers but fragmented, which might result in a less     effective recovery and rehabilitation of patients. Accordingly, the Paracelsus Medical     University Salzburg (PMU) and the Austrian Social Insurance for Occupational Risks (AUVA)     initiated the Austrian Spinal Cord Injury Study (ASCIS) at the beginning of 2012. ASCIS is     defined as an organized network that uses observational methods to collect uniform     longitudinal clinical data that can provide insight into current patient care parameters and     evaluates the outcome of SCI patients. ASCIS was initiated with the aim to develop a registry     for patients with tSCI in Austria as a base for addressing research questions, improving     patient outcomes and establishing a platform for future clinical trials. Furthermore, a major     goal of ASCIS is to get knowledge about the natural recovery after spinal cord lesion in a     larger population of patients in the sense of a historical control group and bring new     standardized assessment tools to the clinical setting. Due to the involvement of acute trauma     hospitals and rehabilitation centers, ASCIS is uniquely positioned to capture detailed     hospital-related information on the (very)-acute, rehabilitation and chronic phases of tSCI     patients. Additionally, ASCIS is cooperation partner of the European Multi-Center Study about     Spinal Cord Injury (EMSCI).   "
13420|NCT03109769|"     The study aims to investigate the effect of the use of mobile phone application sending     reminders to patients with orthodontic fixed appliances on oral hygiene.   "
13421|NCT03109756|"     The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome     (FXS) or Angelman syndrome (AS).        -  The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101          following a single 5 mg dose of OV101 in adolescents with FXS or AS.        -  Secondary objectives are to determine the safety and tolerability of a single 5 mg dose          of OV101 in adolescents with FXS or AS.   "
13422|NCT03109743|"     The investigators will conduct a pilot randomized controlled trial (RCT) of Sisters-GPS with     HIV-positive women of color with suboptimal ARV adherence and detectable HIV viral loads     (VL). Participants will be randomized to Sisters-GPS (intervention involving weekly group     clinical visits for seven weeks plus social media website) or appointment with an adherence     counselor (a minimum of 3 visits) (control condition). Data sources will include interviews,     medical and pharmacy records, and blood samples. The primary outcome will be ARV adherence at     the completion of the intervention assessed via pill count. The secondary outcome will be HIV     VL suppression.   "
13424|NCT03109717|"     Study TRD subjects' resistance to at least 2 different antidepressants, we hypothesize that     because of their significant depression and treatment resistant status they are most likely     to exhibit BSMN pathway abnormalities.   "
13425|NCT03109704|"     This study evaluates the immediate effects of a supine upper thoracic spine thrust     manipulation, seated upper thoracic spine thrust manipulation, and sham manipulation for     individuals with subacromial pain syndrome. The participants were randomized to receive one     of the three interventions and baseline measures for the dependent variables were repeated     immediately after the delivery of the intervention.   "
13426|NCT03109691|"     Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in     Thyroid Surgery   "
13427|NCT03109678|"     The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as     well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version     of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to     the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.   "
13428|NCT03109665|"     Glaucoma is the leading cause of irreversible blindness worldwide. It is caused by damage to     the optic nerve between the back of the eye and the brain leading to progressive blindness.     The cause is poorly understood but ageing, increased intraocular pressure (IOP) and genetics     are all likely to play a role. There is no cure for glaucoma but treatments are available     which slow progression. Because vision cannot be restored once lost, early detection,     monitoring and early treatment are all essential to preserve visual function.      The condition is diagnosed using a combination of the appearance of the optic nerve on     clinical examination or photograph and visual field testing (perimetry). Measurement of IOP     and measurement of the thickness of the retinal layers at the back of the eye complement     diagnostic decisions.      The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) study does not     include perimetry in the series of tests carried out on all participants but does include     photography of the optic nerve, measurement of IOP and measurement of retinal thickness.     Therefore we propose to invite back participants of the NICOLA study who have abnormal optic     discs and high eye pressure to return for perimetry to confirm a diagnosis of glaucoma.     Calling back participants for perimetry is essential to make the diagnosis not only for     estimating prevalence but also for identifying participant's ill-health.      The primary aim of this study is to quantify the number of participants in the NICOLA study     who have glaucoma and report its risk factors. This will allow an estimate of the number of     people in the whole of NI with glaucoma. We will also perform a series of novel tests using     state-of-the-art technologies to assess if they are better than current tests at diagnosing     glaucoma. This may enable better informed decisions about policy decisions in eyecare.   "
13429|NCT03109652|"     The usefulness of tranexamic acid(TXA) to reduce blood loss and transfusion in total knee     replacement arthroplasty(TKRA) has been demonstrated. However, the optimal does, duration of     treatment and route of administration of TXA to reduce blood loss while minimizing adverse     effects remain uncertain. Recently, the serial use of perioperative IV and post-operative     oral TXA has been shown to significantly reduce transfusion rate without increasing     thromboembolic complications compared to placebo. The aim of this study is to 1) determine     the beneficial effect and safety of the serial treatment of IV and oral TXA over IV use alone     and 2) assess the sufficient length of postoperative use of oral TXA in TKRA patients.   "
13430|NCT03109639|"     Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the technique of choice to     evaluate solid gastrointestinal (GI) lesions. The tissue acquired using this technique is     essential for diagnosis of diseases like sub-mucosal masses (GIST), lymphoma, autoimmune     pancreatitis and pancreatic cancer. Also the availability of adequate tissue will enable     performance of molecular profiling and personalized oncologic therapy. The current needle     used for tissue acquisition rarely provides tissue blocks needed for histology assessment.     Hence, a better needle device with a good safety profile is needed to solve this technical     difficulty. The new AcquireTM fine needle biopsy device could over come this difficulty     because of its unique designs. The additional cutting edge surface allows better tissue     access and provides core tissue (>90%) for histology. The safety profile of this new device     is comparable to the conventional FNA needle thereby making it an ideal device for tissue     acquisition.   "
13434|NCT03109587|"     This study evaluates the feasibility and effect of a customized synbiotic on glycemic control     in obese adolescents.   "
13435|NCT03109574|"     This is a prospective, multi-center health economic study in Canada. Participants will be     randomly assigned to receive either the study or control dialysis catheter. The primary     objective is to evaluate resource utilization in Ontario related to hemodialysis catheter     placement including tPA usage, catheter exchange rates, catheter patency, and missed dialysis     days.   "
13436|NCT03109561|"     Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for     cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2,     E3, and E4. Some studies suggest that the different versions of apoE have varying effects on     whole body and brain metabolism. The goal of this project is to better understand the     relationship between apoE and metabolism. This will help investigators identify new targets     for the prevention and treatment of cognitive decline and dementia.   "
13437|NCT03109548|"     The purpose of the project is to associate pre-treatment pain sensitivity level, levels of     pain catastrophizing and levels of The Subgroups for Targeted Treatment (STarT) Back     Screening Tool in patients with acute low back pain and patients' progression after 12 weeks     of treatment by general practitioners.   "
13438|NCT03109535|"     The aim of this study is to determine if participants randomized to our mHealth MapTrek game     increases daily physical activity (average steps/day, active minutes/day) compared to a     control group among sedentary office workers over 10 weeks. The investigators hypothesize the     MapTrek intervention group will significantly increase their daily steps and active minutes     compared to the control group over 10 weeks.   "
13439|NCT03109522|"     The purpose of this pilot study is to compare a new surgical technique (axillary reverse     mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast     cancer.   "
13440|NCT03109509|"     Historically, increasing activity was synonymous with exercise; however, it is now thought     that even much more modest activity levels (e.g., simply walking) or merely decreasing the     proportion of sedentary time may be sufficient to decrease future morbidity and mortality.     Some interventions designed to increase activity have shown promise; others have been less     successful. But even promising interventions are often difficult to generalize to real-life     clinical settings. One barrier to monitoring the effectiveness of interventions has been the     lack of availability of accurate, reliable and inexpensive personal activity monitoring     equipment. The availability of inexpensive pedometers, and, more recently, low cost triaxial     accelerometers, has now made it much easier to monitor activity levels and provide feedback     to users. These devices are ideal for capturing activity associated with walking, the most     popular and acceptable form of exercise, but only if patients actually wear them. Thus, there     is a need to develop pragmatic approaches that encourage patients to not only wear these     monitoring devices, but also motivate them to increase their activity.      In recent years, games have been used in a variety of settings to motivate and change     behavior. Games not only provide performance feedback to patients, but also provide     incentives for achieving goals in a context that is fun, intrinsically rewarding, and easy to     understand. Successful games effectively exploit motivating social factors (e.g.,     competition, peer support, and entertainment) to maintain interest and engage participants.     Steps are counted using a commercially available triaxial accelerometer (e.g., a FitBit).     Pokemon Go is an augmented reality game that encourages players to go outside to search for     Pokemon creatures.   "
13441|NCT03109496|"     This study analyses which bacteria are present in the middle ear space and adjacent upper     respiratory tract niches in healthy people and in patients suffering from chronic otitis     media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are     more common and more abundant in healthy people and to evaluate their potential to protect     against bacteria commonly involved in OME and other upper respiratory tract infections.      To this end, samples will be collected from both groups (healthy vs OME) and analysed through     sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants     will be cultivated to isolate bacteria of interest.   "
13442|NCT03109483|"     The aim of this study is to investigate the effectiveness of our developed week-treatment     program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to     achieve a better independence for activities of daily living (ADL).      Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect     of the rehabilitation; strength, balance, speed, functional training and one day is for     testing or group therapy.      Participants will be followed for four weeks, with testing on day one, after two weeks and at     the last day of the four-week program.   "
13443|NCT03109470|"     Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this     study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients     who were treated with Tocilizumab to require treatment with another biologic medication.   "
13444|NCT03109457|"     Compare Hepatiis C Virus (HCV) detection between oral squamous cell carcinoma (OSCC) and     normal tissues, to determine the possible relationship between HCV and OSCC.   "
13445|NCT03109444|"     This study aims to collect normative population data on the ultrasound radiographic     parameters used to evaluate hip dysplasia in infants between 32 and 46 weeks of gestational     age. This data would be utilized to develop a growth chart with standard deviations for this     cohort that would be beneficial in the appropriate treatment of suspected hip dysplasia.   "
13465|NCT03109184|"     This study will develop and test a web-based intervention to enhance emotion regulation     skills and parent-son relationship communication to decrease adolescent boys' risk for dating     violence involvement as well as attitudes supporting relationship aggression.   "
13469|NCT03109132|"     The purpose of this test is to evaluate the comfort level of several model configurations of     the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by     the device, mainly due to tubes around the ears and on the face skin, the cannula itself     (especially in the nostrils and the mouth surrounding) and the smell.   "
13470|NCT03109119|"     This study aims to find out if sevoflurane causes any cell damage to patients undergoing     general anaesthesia. In case of any damage, the reversibility of the damage is also assessed.     This is a prospective, comparative study carried out in all children scheduled for surgical     repair of cleft lip or palate admitted in the Department of Plastic Surgery under Smile Train     organisation ìn our hospital,who satisfy the inclusion and exclusion criteria.   "
13446|NCT03109431|"     Optimizing the HIV Treatment Continuum with a Stepped Care Model for Youth Living with HIV     (YLH) aims to achieve viral suppression among YLH. A cohort of 220 YLH will be identified in     Los Angeles, CA and New Orleans, LA and recruited into a randomized controlled trial (RCT)     with reassessments every 4 months over a 24 month follow-up period. The goal is to optimize     the HIV Treatment Continuum over 24 months. YLH will be randomized into one of two study     conditions: 1) Enhanced Standard Care Condition (n=110); or 2) Stepped Care (n=110). The     Enhanced Standard Care condition will consist of an Automated Messaging and Monitoring     Intervention (AMMI) with daily motivational, instructional and referral text messaging, and a     brief weekly monitoring survey. The Stepped Care Condition will consist of three levels.     Level 1 is the Enhanced Standard Care Condition. Level 2 is the Enhanced Standard Care     Condition plus peer support using social media. Level 3 is the Enhanced Standard Care     Condition and peer support plus coaching, which will be delivered primarily through     electronic means (e.g., social media, text messaging, email, phone). All participants in the     Stepped Care Condition begin at Level 1 but if they fail to have a suppressed viral load at     any four-month assessment point, their intervention level will increase by one step until     reaching Level 3.   "
13447|NCT03109418|"     The aim of this study is to substantially reduce overall postoperative morbidity and     mortality associated with obstructive sleep apnea.   "
13448|NCT03109405|"     The purpose of this study was to examine the Veinplicity Device as an adjunctive IV     cannulation tool in subjects with a history of difficult to access veins. The Veinplicity     Device is intended to improve venous access rates in compromised patients by taking advantage     of the increased circulation that results from provoked muscle stimulation. The study     collected information about the device, intravenous access, user and patient perceptions for     IV access, and any device or procedural complications or other adverse events. Device use was     examined with patients in both a prone and upright position.   "
13449|NCT03109392|"     Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of     tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most     distressing symptom experienced by the patients is a cough, and control of a cough is vital     for a successful procedure. The investigators hypothesized that either nebulized lignocaine     or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical     anesthesia will have similar efficacy compared to the combination of the two agents.   "
13450|NCT03109379|"     The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery     system, is safe and tolerable in patients with idiopathic overactive bladder and urinary     incontinence.   "
13451|NCT03109366|"     This project's overall objective is to contribute to knowledge and innovation needed to     advance ICT-arenas for timely, secure and seamless collaboration between chronically ill     patients and appropriate levels of care. The investigators will expand an Internet solution     that has successfully supported online patient-provider communication into a device-     independent mobile, multifunctional ICT platform, called Connect 2.0, to support individually     tailored collaborative care between patients and care providers on the continuum of     primary-specialist care. The results will contribute to Norway's Collaboration Reform.     Integrating theories from health and ICT related sciences, the project is organized into five     work packages that focus on two of VERDIKTs research themes: social networking and mobile     internet. We will summarize (1) the current state of collaborative health care models and     their utilization of ICT research and innovations; explore challenges related to (2)     information exchange between devices, platforms and systems; (3) human-computer interaction,     (4) data security and confidentiality; and (5) factors related to successful adoption and     implementation of Connect 2.0 patient-provider collaborative care. Finally the investigators     will explore how Connect 2.0 impacts interactions, communication and organizational processes     in collaborative real world care.      Specifically this study will:        1. Summarize the current state of collaborative health care models and their utilization of          ICT research and innovations.        2. Explore challenges and propose solutions for adapting a mobile multifunctional ICT          platform (Connect 2.0) into the technical and organizational infrastructures of          collaborative health care.        3. Through user-centred design methods address challenges related to human computer          interaction and usability of Connect 2.0.        4. Explore challenges and feasible solutions that safeguard data security and          confidentiality when connecting an Internet solution with a protected health net while          ensuring safe and efficient data transfer through heterogeneous networks.        5. Explore factors related to successful adoption and implementation of Connect 2.0 in real          world collaborative care. Based on the above: explore impacts of a test version of          Connect 2.0 on interactions, communication and organizational processes.      The work expands partnerships between the Centre for research-based innovation (SFI)     consortium (7 business / research partners) called Tromsø Telemedicine Laboratory (TTL), the     Norwegian Telemedicine Center (NST), the Center for Shared Decision Making and Nursing     Research (CSDM) at Oslo University Hospital, the Department of Computer Science, University     of Oslo, the University Hospital of Northern Norway (UNN), Balsfjord Municipality, the     Biomedical Information Research Center at the Marshfield Clinic Research Foundation, and the     Department of Biomedical informatics at Columbia University in New York.   "
13452|NCT03109353|"     Extracorporeal photopheresis (ECP), is commonly used for the treatment of cutaneous T-cell     lymphoma (CTCL) and chronic graft-versus-host disease. ECP (cGVHD) is an immune modulating     treatment. White blood cells from the patient are standardized activated by a photosensitizer     psoralen (8-MOP) and irradiated with visible ultraviolet light (UV-A). The purpose is to     induce programmed cell death (apoptosis). Disadvantage of current treatment is that 8-MOP     targets both diseased and normal cells with no selectivity.      The purpose of this study is to improve the current ECP technology using aminolevulinic acid     (ALA) and UV light. ECP will be carried out in conventional manner except that 8-MOP will be     replaced with ALA. Systemic ALA / UV light is already approved and used in the detection and     treatment of disease in humans. The primary objective is to assess its safety and     tolerability after single and multiple treatment in patients with CTCL or cGvHD.   "
13453|NCT03109340|"     Objective: To show the effectiveness of walking with ECE PEDO (Equipment for Clever Exercise)     comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on     abdominal obesity and cardiorespiratory capacity.   "
13454|NCT03109327|"     The purpose of this study is to establish the clinical utility of the Melanoma Detection     System (MDS).   "
13455|NCT03109314|"     The research deals with amblyopia or lazy eye, a condition that affects about 3% of the     population, and results in a variety of visual deficits. Recent work suggests that there is     limited neural plasticity in the visual system of adults with amblyopia. This study is aimed     at understanding and increasing this plasticity. In this study, the investigators aim to     understand how the amblyopic brain learns and how this process is affected by a drug called     donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators     hope that this study will help to identify the chemical components that help the brain to     learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal     periphery, as control.   "
13491|NCT03108846|"     The purpose of this study is to evaluate the safety and efficacy of escitalopram for     agitation in Alzheimer's dementia.   "
13492|NCT03108833|"     This trial is being conducted to assess the efficacy and safety of recombinant Human     Prourokinase in the acute pulmonary embolism.   "
13457|NCT03109288|"     Background:      In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers     indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined     affect MS biomarkers. They want to see if a change in biomarker levels can predict which     drugs a person with MS might respond to.      Objective:      To see if signs of inflammation in CSF help predict a person s response to different drugs.      Eligibility:      People ages 18 75 who:      Are in protocol 09-N-0032      Have progressive MS      Can stand and walk a few steps      Take an MS drug      Design:      Participants will be screened in protocol 09-N-0032.      Participants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how     they are doing. Some will start a second drug. They may take each drug or combination for up     to 18 months.      Participants will have 2 visits a year for up to 6 years. Visits include:      Medical history      Physical exam      Blood and heart tests      X-rays and scans      Eye exam and tear collection      Lumbar puncture: A needle inserted between back bones removes some CSF.      Lymphocytapheresis: Blood is removed through a needle in one arm and run through a machine.     The blood is returned through a needle in the other arm.      A sensor on the forehead records blood flow and oxygen use.      Participants may get a device for testing at home.      Participants will stop taking the drugs if they have taken 2 drugs together for 18 months or     if they do not do well on the drugs.      Participants will be called 3 months later to see how they are doing.   "
13458|NCT03109275|"     The main aim of this project is to develop a new model to characterize brain connectivity and     its changes with aging. This characterization will be based on new sensitive and specific     markers, allowing a better understanding of structural and functional brain networks. To this     end, two complementary MRI methods will be developed: 1) Resting-state functional MRI     (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter     regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to     characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and     reconstruct fiber tractography of patient's brains. In combination with conventional MRI,     both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of     cortical regions, so- called Connectome. Once generated, brain networks will be quantified     through numerous graph metrics, such as graph density, global efficiency and assortativity     (etc.), reflecting the organization and topology of subjects' connectivity with aging.   "
13459|NCT03109262|"     This clinical trial studies how well yttrium Y 90 glass microspheres positron emission     tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors. Images     produced by PET/CT may provide better information about the distribution of particles, such     as yttrium Y 90 glass microspheres, delivered for selective internal radiation therapy (SIRT)     compared to the technetium Tc-99m albumin aggregated single photon emission computed     tomography (SPECT)/CT images.   "
13460|NCT03109249|"     SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used     extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other     solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.   "
13461|NCT03109236|"     This proposal translates a hypothesis driven basic research into clinical setting to     determine the potential of using autologous CD133+ cells to reverse fibrosis and improve     clinical outcome for patients with end stage cirrhosis. This has significant impact on the     management of cirrhosis.   "
13462|NCT03109223|"     OBJECTIVES:      Primary:      The primary objective is to determine whether the mean weight gain over a 16-week interval     starting on or before 14 days of life differs between infants fed one of two infant formulas     as their sole source of nutrition: a commercial formula using a canola l fat blend (Control,     E23) or the same formula containing the human milk oligosaccharide (Test (HMO)     2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently     enrolled reference group of exclusively breastfed infants.   "
13463|NCT03109210|"     This two-site randomized clinical trial will investigate and compare three treatments for     insomnia in patients who have been diagnosed with and treated for sleep apnea: online     cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT),     and standard clinical care. 384 patients will be recruited and will attend up to 15 visits     over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment     follow-up visits. Visits will involve completion of questionnaires, meeting with therapists,     and a physical exam.   "
13464|NCT03109197|"     The purpose is to increase the understanding of the characteristics, circumstances, medical     histories and pathologies of children from ages 11 months through 18 years who have died     suddenly and unexpectedly, and in some instances, without explanation. The SUDC Registry and     Research Collaborative will analyze cases of sudden unexpected deaths in these children to     understand risk factors and causes, and develop preventative measures.   "
24174|NCT02969239|"     The purpose of this study is to compare norepinephrine and phenylephrine on the effects of     maintaining the cardiac output in Cesarean section under spinal anesthesia.   "
13466|NCT03109171|"     This is a prospective double blinded randomized crossover controlled trial aiming at     validating the measurement of laryngopharyngeal mechanosensitivity in patients with suspected     OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder     (LPEER).      Subjects will be recruited from patients with suspected OSA referred for baseline     polysomnography to a university hospital sleep laboratory. Intra- and inter-rater reliability     will be evaluated using the Bland-Altman's limits of agreement plot, the intraclass     correlation coefficient, and the Pearson or Spearman correlation coefficient, depending on     the distribution of the variables. Diagnostic accuracy will be evaluate plotting     Receiver-operating-characteristic-curves (ROC-curves) using as reference standard basal     polysomnogram. The sensory threshold values for patients with mild, moderate, and severe OSA,     will be determined and compared using ANOVA or Kruskal Wallis test, depending on the     distribution of the variables.   "
13467|NCT03109158|"     Part 1 of this study will establish a recommended Phase II (RPII) dose for the triplet     combination of NC-6004 plus 5-Fluorouracil (5-FU) and cetuximab. Part 2 will provide the     efficacy signal of the triplet combination in this patient population.   "
13468|NCT03109145|"     The purpose of this research study is to examine the impact of educational secure messages on     menopause. In particular, the investigators will examine whether the secure messages increase     menopause knowledge and communication between patients and their providers.   "
13471|NCT03109106|"     Antibiotics are overused in hospitals nationwide, leading to unnecessary drug costs and     adverse events. Antibiotic stewardship is now a national and international priority and     regulatory authorities are mandating antibiotic stewardship programs in all hospitals.     Respiratory infections account for a large percentage of antibiotic overuse. Procalcitonin     has been shown to help providers significantly shorten the duration of antibiotic therapy in     respiratory infections. As such, our institution seeks to evaluate the impact of PCT-guided     antibiotic management on antibiotic use in subjects with acute Lower Respiratory Tract     Infection (LRTI) with or without sepsis. Multiple studies have been conducted in Europe and     demonstrate the safety of the PCT-guided antibiotic management in pneumonia as well as     sepsis. Our study will apply PCT-guided therapy to those populations in an all-US study     evaluating patient outcomes along with safety and efficacy.   "
13472|NCT03109093|"     This study is designed to confirm the efficacy, safety, and tolerability of blinatumomab in     patients with MRD of B- precursor ALL in complete hematological remission including patients     with relapse after SCT. The study aims to expand experience generated in previous trials in     patients with MRD positive ALL with a focus on additional specific questions.   "
13473|NCT03109080|"     A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally     Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC     with Residual Disease.   "
13474|NCT03109067|"     Reverse cholesterol transport (RCT) pathway explains the anti-atherosclerosis role of HDL.     Post prandial hypertriglyceridemia is highly predictive of atherosclerosis. TaqIB     polymorphism in CETP gene plays a role on HDL particles, and might give a link between TaqIB     polymorphism and the cardioprotective efficiency of HDL particles. Our main objective was to     compare post-prandial HDL particles between patients having B2 allele carriers (genotype AA)     to B1 allele carriers (genotype GG), and their ability to mediate cellular cholesterol     efflux, via SR-BI Scavenger Receptor class B type I (SR-BI) , ABCG1 and ABCA1 pathways.   "
13475|NCT03109054|"     Bariatric surgical procedures are associated with low short-term mortality and may be     associated with long-term reductions in all-cause, cardiovascular, and cancer-related     mortality. This surgeries are major surgeries include risk of mortality still.      Different level anxiety that can define as fear or worry can be seen in 60%-80% of patients     scheduled surgery. Anxiety levels; may vary on age, gender, type of operation, previous     experience of anesthesia and surgery and way of hospitalization. Preoperative anxiety affects     negatively the surgery, the anesthesia and postoperative recovery.      Melatonin is a hormone secreted from the pineal gland. The circadian rhythm of melatonin     changes according to age and it's production decreases with older ages. Melatonin is an     antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic,     sedative, analgesic and has a preventive effect of delirium in intensive care. Irregularity     of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and     some behavioral disorder. It has been demonstrated that oral exogen administration of     melatonin was effective on preoperative anxiety.      The aim of this study was to determine the relationship between endogenous melatonin levels     and anxiety levels in patients with bariatric surgery.   "
13476|NCT03109041|"     This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that     utilizes active components (Palladium-103) of standard devices in a novel configuration. This     study may benefit resectable pancreatic cancer patients by reducing the radiation dose to     adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at     a surgical margin.   "
13477|NCT03109028|"     The objective of this study is to investigate a stepped and collaborative care model (SCCM)     for adolescent and adult refugees suffering from depression living in Germany.   "
13508|NCT03108625|"     Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent     patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)     diagnosis of MDD   "
13690|NCT03106246|"     Beta-cells release extracellular vesicles (EV) and exosomes under normal and pathophysiologic     conditions. These EV contain beta-cell specific autoantigens which may trigger the immune     response at the initiation of type 1 diabetes. In this study, beta-cell derived EV will be     detected and characterized in human blood samples.   "
13478|NCT03109015|"     The purpose of this study is to determine the effect of a sunitinib administration schedule     2/1 (2 weeks of treatment followed by 1 week without) compared to a schedule 4/2 (4 weeks of     treatment followed by 2 weeks without) on cardiopulmonary function in subjects with renal     cell carcinoma. Subjects will be randomized 1:1 to one of two arms: 4/2 schedule of sunitinib     administration or 2/1 schedule of sunitinib administration. Cardiopulmonary function will be     assessed at baseline, week 4 (4/2 schedule only), week 5 (2/1 schedule only) and week 12. The     investigators hypothesize that schedule 2/1 of sunitinib is not only better tolerated but     will be associated with less fatigue and functional cardiovascular/muscular toxicity than the     4/2 schedule.   "
13479|NCT03109002|"     The purpose of this study is to describe the epidemiology of Treatment Resistant Depression     (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of     Pharmacologically Treated Depression (PTD), and stratify the estimates by sex and age group,     with separate estimates for the Medicaid population, the Medicare population, and the     privately insured population. Anonymized participants data will be used for the analysis.   "
13495|NCT03108794|"     CR-HepB registry started in June 30,2012 to collect HBV cases from general hospitals or     specialized hospitals for infectious diseases in mainland China. Demographics, diagnosis,     laboratory test results, family history and prescriptions were recorded. The main criteria     for registration is HBsAg-positivity more than 6 months, and these patients will receive     followed-up visits every three to six months.   "
13496|NCT03108781|"     Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe     dementia who are hospitalized in the ward for the mentally frail.   "
13497|NCT03108768|"     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted     on hard of participants with a hearing loss to grant quality control prior to product launch.     The aim of the investigation series is to ensure zero-defect overall performance of the new     hearing systems as well as maximum benefit for the participant with the devices in comparison     to previously outstanding Phonak Hearing Systems.   "
13480|NCT03108989|"     Sugammadex has been approved as the first targeted reversal binding agent providing     predictable and complete reversal of neuromuscular blockade induced by rocuronium or     vecuronium, and achieving so with a favourable safety profile.      Its benefits over traditional acetylcholinesterase inhibitors have been widely demonstrated     in many studies. The scope of such studies has been mostly related to the efficacy of NMB     reversal and safety. However, the clinical use of sugammadex led some anaesthesiologists to     observe that following the use of this agent, patients seemed to recover consciousness faster     and look like they were feeling better. To present, there is little information on the effect     of sugammadex on awakening from anaesthesia.      The quality of postoperative recovery focused around patient-oriented endpoints has raised     new interest as a measure of the quality of anaesthesia and a target towards which     improvement can be directed.      On the other hand, there is no single prospective study performed to address a possible     effect of sugammadex on recovery from anaesthesia.      The objective of this study was to compare the effect of sugammadex and neostigmine on the     quality of postoperative recovery using the PQRS in elderly patients undergoing trans pars     plana vitrectomy with general anesthesia   "
13481|NCT03108976|"     Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core     feature is social and communications disorders. Motor skill impairments are frequently     described in autism, but few studies have addressed the question of their origin and their     specificity. Furthermore, it is not clear whether motor problems encountered in autism are     related to dyspraxia, or if they present with specific features. This project aims at     deciphering the origin of motor problems encountered by children who grow-up with autism in     order to propose early interventions that could influence the other developmental     trajectories, such as the social one.      Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography     (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely:     proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory     executive control will be correlated to brain oscillation modulation, both topographically     and temporally. Two groups of children (aged between 7 and 12) are compared: a group of     children with ASD and a control group of typically developing children.   "
13482|NCT03108963|"     L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and     metabolic effect: a randomized clinical trial   "
13483|NCT03108950|"     The specific aim of the study in our example is to conduct a feasibility translational     home-based exercise trial established in the LEADERS (R2) project with the TExt-ME     tele-exercise training system for participants with neurologic disability. We hypothesize     that participants in this home-based tele-exercise training program will achieve similar     gains in health and function outcomes as the onsite exercise training program. Further, there     will be no difference in adverse side effects (safety) between the home-based and onsite     exercise treatment groups.   "
13484|NCT03108937|"     Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery.     Previous studies in cells and animals show that dexmedetomidine may promote cancer growth.     Using serum from breast cancer surgery patients randomized to receive dexmedetomidine or     saline during surgery, we investigated the effects of dexmedetomidine on proliferation,     migration and metastasis in MCF-7 breast cancer cells in vitro.   "
13485|NCT03108924|"     This trial aims to evaluate the plasma pharmacokinetics of gefapixant (MK-7264) administered     to participants with varying degrees of renal insufficiency (RI) compared to healthy matched     controls; and to investigate the extent of MK-7264 removal by hemodialysis in participants     with end stage renal disease (ESRD), following administration of a single 50 mg dose of     gefapixant.   "
13486|NCT03108911|"     This randomized phase II trial studies how well a gluten free diet works in diminishing side     effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten     free diet may result in less intestinal side effects and blood infections during the     induction chemotherapy compared to a standard diet.   "
13487|NCT03108898|"     The purpose of this study is to better understand how esophageal cells change with age.   "
13488|NCT03108885|"     To prospectively collect blood and tumor tissue from esophageal cancer patients to identify     specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during     the course of treatment as a marker of response and recurrence.   "
13489|NCT03108872|"     We will compare long-term effectiveness and safety in patients with atrial fibrillation     treated with left atrial appendage occlusion versus new oral anticoagulants to prevent     ischemic stroke from multicenter registry data   "
13490|NCT03108859|"     To establish a spine injury and spinal cord injury (SCI) treatment database; to complete pre-     and in-hospital evaluation of spine injury and SCI, develop and optimize first aid     procedures, form pre-and in-hospital standardized training program for the treatment of spine     injury and SCI; to develop first aid guidelines and establish an evaluation and treatment     system for early surgery, as far as possible to save the spinal cord function and reduce the     degree of disability; to form expert consensus on acute SCI and green channel patterns,     will be promoted in hospitals in Beijing and other cities of China, so as to improve the     level of first aid treatment of acute spine injury and SCI in Chinese cities, and to reduce     the occurrence of secondary injury and severe dysfunction due to improper treatment.   "
13493|NCT03108820|"     This proposal aims to conduct a randomized controlled trial to evaluate the efficacy of a     6-month collaborative care intervention in improving the functional and psychological     recovery of 430 injury survivors 50 and older. The trial has the following specific aims: 1)     Evaluate the ability of the TMH intervention to improve the physical recovery of older injury     survivors; and 2) Evaluate the ability of the TMH intervention to improve the psychological     recovery of older injury survivors; and 3) Evaluate the ability of the TMH intervention to     reduce healthcare costs of older injury survivors and evaluate the cost of effectiveness of     the TMH intervention.   "
13494|NCT03108807|"     The aim is to determine if the National Early Warning Score combined with plasma D-dimer     levels can be used in risk stratification of acutely ill medical patients presenting to a     Danish Emergency Department. The investigators wish to identify patients at low risk of     mortality within 30 days.   "
13514|NCT03108547|"     The investigators studied whether scalp hair cortisol and testosterone levels differed     between sarcoidosis patients both with and without fatigue and healthy controls.   "
13498|NCT03108755|"     This is a combined Single and Multiple Ascending Oral Dose Study. Part 1 is a Single     Ascending Dose (SAD) and Part 2 is Multiple Ascending Dose (MAD).      The purpose of the study is to evaluate the safety and tolerability of single and multiple     ascending oral doses of ASP7713 in healthy non-Japanese (Part 1) and Japanese (Part 2) adult     participants and non-Japanese elderly participants (Part 2).      This study will also evaluate the pharmacokinetics of single and multiple ascending oral     doses of ASP7713 in non-Japanese (Part1) and Japanese (Part 2) adult participants and     non-Japanese elderly participants (Part 2) as well as the effect of a single and multiple     oral dose of ASP7713 on the QT interval using Fridericia's Correction (QTcF).      In addition, this study will evaluate a potential racial difference in safety, tolerability     and pharmacokinetics of multiple oral doses of ASP7713 in healthy non-Japanese and Japanese     adult participants (Part 2).   "
13499|NCT03108742|"     In this study, a randomized controlled study was conducted between two groups of 20 classic     recipients of intradermal sutures and 20 recipients of intradermal staple methods for     patients undergoing the same cervical incision. This is a study to see if there is any     difference in pain and esthetics in scar formation of these groups.   "
13500|NCT03108729|"     A drug study to determine the long-term safety and tolerability in children and adolescents     (4-17 years in age) taking the drug (elsicarbazepine acetate)   "
13501|NCT03108716|"     To compare the effects of hamate hook removal, microscrew internal fixation and plaster     fixation on fracture healing, work, life, and exercise recovery in patients with hamate hook     fractures by retrospective case analysis.   "
13502|NCT03108703|"     Stereotactic body radiotherapy (SBRT) is an emerging radiotherapy technique that precisely     delivers high doses of radiation to tumours. It has been investigated as definitive treatment     for an increasing variety of primary tumours including lung, liver, prostate, and now renal     cell carcinoma (RCC). The principal aims of this study are to prospectively assess quality of     life (QoL) and oncologic outcomes in non-surgical patients who receive SBRT for the treatment     of RCC.   "
13503|NCT03108690|"     The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI)     of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.   "
13504|NCT03108677|"     The purpose of this study is to learn whether the profile of RNA from circulating exosomes     can be used as a biomarker for lung metastases of primary high-grade osteosarcoma.     Circulating exosomes plays roles in metastases in many kinds of cancer including     osteosarcoma. By RNA profiling researchers may find lung metastases earlier than conventional     work-up and predict the oncological outcomes.   "
13505|NCT03108664|"     The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and     effective in the treatment of signs and symptoms of Dry Eye Disease.   "
13506|NCT03108651|"     About 100 (50 from TMU Hospital and 50 from Wellcome Clinic) current smokers will be     recruited who contact smoke cession clinics in teaching hospitals of Taipei Medical     University (TMU) and Wellcome Clinic. They will be randomly assigned either to Usual Care     (UC) or Usual Care plus 3M4Chan Intervention group (IG). A randomized comparative     effectiveness trial will be conducted. T8.5.1. Patient will enroll from July 2017 to January     2018. In UC group, the physician provides a brief advice to quit during first consultation, a     quit plan template, and medication prescription (Varenicline, Bupropion, Champix, Nicotinell     TTS20) as decided by the physician. IG group includes UC plus a mobile App that is programmed     to push tailored messages for health concern and readiness to quit, tips for sustaining     abstinence, use of interactive self-assessments, helpful cessation information. This group of     smokers will benefit from tailored cessation interventions with integrated body weight     management elements that take into consideration the prevailing local and cultural influences     on diet and levels of physical activity. IG will be continued even after stopping of the UC.   "
13507|NCT03108638|"     Opportunities to implement and evaluate system-wide change are rare. This observational,     Hybrid II study leverages a real-world, system-initiated roll-out of R3, a     supervisor-targeted implementation strategy aimed at infusing the use of evidence-based     principles across multiple levels of the workforce within a public child welfare system. This     project aims to study the effectiveness of R3 in impacting organizational inner-context     variables and subsequent positive outcomes for one of the nation's most costly and vulnerable     populations—families involved in the child welfare system.   "
39267|NCT02771665|"     To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer     recurrence and survival outcome in patients with invasive breast cancer after surgery   "
13510|NCT03108599|"     The current project is a safety and health intervention focused on sleep and fatigue among     truck driver teams (pairs), where one driver sleeps in a moving vehicle while the other     partner drives. This study is conducted within the Oregon Healthy Workforce Center (OHWC), a     NIOSH Center of Excellence in Total Worker Health. We will evaluate engineering and     behavioral interventions to improve sleep, reduce fatigue, and impact Total Worker Health. An     enhanced cab intervention will alter whole body vibrations during driving and sleep periods,     and includes a therapeutic mattress system and an active suspension seat. The enhanced cab     will be evaluated alone and in combination with a behavioral sleep intervention adapted from     our effective SHIFT (Safety &Health Involvement For Truckers) program. The interventions     prioritize hazard reduction according to the hierarchy of controls, and will be evaluated     with a randomized controlled design.   "
13511|NCT03108586|"     This study will evaluate the effect of the International Dental Federation (FDI) criteria,     compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for     evaluation of caries lesions around restorations in permanent teeth, in the outcomes related     to oral health of adults, in a randomized clinical trial.   "
13512|NCT03108573|"     This study evaluates different optimized MRI sequences for the detection of brain lesions in     patients with multiple sclerosis in comparison with the recommended FLAIR sequence   "
13513|NCT03108560|"     The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great     number of retrospective studies suggested that sublobar resection was better for some GGO     patients. However, no prospective clinical study supports the perspective. This study is     prospective, multi-center, randomized-controlled. The aim of this study is to investigate     whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or     not.   "
13515|NCT03108534|"     The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler     versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm,     in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second,     FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.   "
13516|NCT03108521|"     With the development of pharmacogenomics and pharmacogenetics, personalized medicine based on     genetic are increasingly required clinically. Incretin-based therapy is currently the most     popular diabetes treatment. This study mainly research the correlation of incretin-related     gene polymorphism and individual differences in the response of these drugs from the     following four aspects.        1. . To study Chinese human gene polymorphism's mutation frequency and allele frequency, by          screening Chinese people gene polymorphisms which affecting DPP-4 enzymatic activity.        2. . To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979,          rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population.        3. . By collecting clinical parameters and efficacy indicators to reveal the relationship          between Chinese DPP-4 gene and GLP1R gene polymorphism on the clinical manifestations          and drug response. This study will be improved based on actual experimental research          methods, and design intervening measures for Chinese people, to explore the dose-effect          relationship of DPP-4 and GLP1R gene polymorphism in the treatment of diabetes in          Chinese population.        4. . Incretins is a new generation hypoglycemic agent. By studying gene polymorphism and          drug response, to research how to plan treatment for clinical diabetes with DPP-4 and          GLP1R gene polymorphism. Provide the basis for individualized treatment of these drugs.   "
13517|NCT03108508|"     The objective of the present study is to evaluate the non-inferiority of the absorption     parameters of three silicon supplements in human volunteers.   "
13518|NCT03108495|"     Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive     cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145)     followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the     treatment of patients with recurrent, metastatic, or persistent cervical carcinoma   "
13519|NCT03108482|"     This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical     trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary     objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by     demonstrating a superior effect compared to tramadol and to celecoxib for the management of     moderate to severe acute post-operative pain for 48 hours after bunionectomy.   "
13520|NCT03108469|"     The purpose of this study is to evaluate the safety, tolerability, and changes in the number     of migraine and headache days with repeated subcutaneous administration of IONIS-PKKRx (ISIS     546254) or placebo in subjects with chronic migraine.   "
13521|NCT03108456|"     This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty     technique for the treatment of severely calcified lesions prior to implantation of     drug-eluting stents (DES).   "
13522|NCT03108443|"     Current methods of detecting glaucoma and monitoring its progression over time involve visual     assessment of the optic nerve, thickness measurements of nerve tissue in the eye (using     optical coherence tomography, OCT) as well as functional tests which measure peripheral, or     side, vision. The objective of this study is to determine if a new technique of measuring     blood flow in the eye, using OCT, can be used to better detect and/or monitor changes in     glaucoma patients and suspects than these methods.   "
13523|NCT03108430|"     Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example,     there are no data on the incidence of pneumonia after inhalation and risk factors or     protective factors to develop one since it is known that anyone who inhaled does not     necessarily develop an IP. There is no data on the benefit of treating inhalation by     antibiotic therapy pre-emptively although this practice is common. In this context, this     observational study wishes to take stock of the situation on the subject in order to     determine what actions to implement to prevent IP.   "
13524|NCT03108417|"     This study is designed to determine whether subjects who were responders to cNEP during an     overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a     response throughout the night for up to two weeks in a home setting. It will also be     determined whether two weeks of home use of cNEP is associated with any adverse events.   "
13525|NCT03108404|"     Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm     deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal     membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and     accounts for approximately 30 % of preterm births.      The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its     complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing     enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of     lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an     increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines.     Conservative management to prolong a pregnancy is a classical approach to treat PPROM before     34 weeks' gestation in association with antibiotic therapy and corticosteroids.      Maternal and neonatal data were collected from maternal and newborns medical records.   "
13526|NCT03108391|"     The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway     and LMA Supreme in normal airway patients.   "
13527|NCT03108378|"     Subjects must be scheduled to undergo an orthopedic surgical procedure. Subjects in the     non-control group must have previously received an MRI with MultiHance or ProHance with at     least 1 month between the last administration and the scheduled surgery. Subjects who have     never received MultiHance or ProHance or any other gadolinium agent will also be enrolled.     Subjects must have a test of their kidney function (SCr) at the time of the last MRI     examination or at the time of enrollment if they never received gadolinium.      A sample of bone and skin will be collected from the scheduled surgery and tested for the     amount of gadolinium. An additional sample of skin will be collected for testing the presence     of nephrogenic systemic fibrosis (NSF).   "
13869|NCT03103906|"     Evaluation of the local tolerance and cosmetic efficacy of a topical skin care formulation in     healthy female participants with mild to advanced photo-damaged facial skin who have     undergone a 70% Glycolic Acid facial peel procedure.   "
13528|NCT03108365|"     The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental     dressing in achieving hemostasis post-extraction and determining its effect on pain and     healing of the extraction wound, compared to control, i.e. conventional method of extraction     in patients on oral anti-platelet therapy.   "
13529|NCT03108352|"     The purpose of this study is to verify the efficacy and safety of intravitreal injection of     conbercept in patients with macular edema (ME) caused by branch retinal vein occlusion     (BRVO).   "
13530|NCT03108339|"     Low-back pain (LBP) is a complex and heterogeneous disorder commonly seen in primary health     care. Despite a variety of treatment options available, it seems that few of these prevent     recurrent LBP and chronicity. In addition, when comparing different treatment options, effect     sizes are not impressive, indicating that we either lack effective treatment for LBP,     diagnose poorly or that we measure the outcome of treatment incorrectly. Sub groups within     the heterogeneous group suffering from LBP need to be identified and also markers influencing     treatment efficacy. The project aims to conduct a cohort study with the objective to identify     prognostic markers and sub groups for a successful or poor outcome of low-back pain and     disability in short and long term. We aim to follow the trajectory of pain, to study     interactions of markers and associations with days of pain and activity level. We will     include people seeking physiotherapy care for a primary complaint of LBP to collect data on a     core set of outcome measurements concerning pain, functional limitations, health and quality     of life, self- efficacy and fear avoidance. The data will be collected at baseline, at 8     weeks and 6 and 12 months following an intervention of guideline recommended     physiotherapeutic care comprising information to stay active and exercises enhancing core     stability supervised by experienced physiotherapist. We aim to collect data on movement     control of the lower back and general excessive mobility of the joints at base line. We will     collect longitudinal data on days with troublesome pain and activity level through     text-messages sent every 2 weeks. We will analyze the data with mixed model regression     analyses and cluster analyses to be able to identify predictive factors and interactions to     sub group the participants.   "
13531|NCT03108326|"     RUN-CD is an investigator initiated Non interventional Trial on biologics in Crohn´s     Disease (CD) patients in Germany with a prospective documentation of effectiveness in     induction and maintenance therapy of biologics, especially of Ustekinumab, with a special     interest on predictors of long-term responses and favorable disease outcome and documentation     of severe side effects caused by the therapy with biologics.   "
13532|NCT03108313|"     Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed     to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride     toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be     evaluated another time.   "
13533|NCT03108300|"     Fifty patients with pathological proof of malignant soft tissue sarcoma will receive     Anthracyclin based chemotherapy combined with propranolol 40 mg twice daily.        -  The primary end point : To assess Progression Free Survival (PFS)        -  The secondary end points : To assess Overall Survival (OS) and Toxicity Profile   "
13534|NCT03108287|"     This randomized controlled study aimed to evaluate whether adding bismuth to the standard     first-line triple therapy could improve the eradication rate of Helicobacter pylori (H.     pylori). A total of 162 patients with H. pylori infection were randomly assigned to either     the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81).     The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g     and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added     to the RAK regimen.   "
13535|NCT03108274|"     The purpose of this study is to determine the potential drug interaction between ACH-0144471     and Midazolam, Fexofenadine and Mycophenolate Mofetil   "
13537|NCT03108235|"     Aim: To develop a nurse-led, home-based self-management psychosocial education programme,     entitled HOMe-based HEart Failure Self-Management Programme (HOM-HEMP), and evaluate its     effects in improving health-related quality of life (HRQoL), psychological well-being,     self-efficacy, self-care behavior and social support, as well as clinical outcomes among     older patients with CHF in Singapore.      Background: The number of elderly people is expected to increase in the coming decades, and     so too the prevalence of with chronic heart failure (CHF) is expected to increase. Since CHF     is a chronic condition, there is a need to develop programmes that will improve the quality     of life of older patients who have to manage this condition for years to come.      Design: A stratified, three-arm randomised controlled trial (RCT) will be adopted.      Methodology: The HOM-HEMP is designed a six-week home-based psychosocial education programme     comprising of a specifically developed HF Tool Kit and a supplementary smartphone app. A     consecutive sample of 213 older patients with CHF will be recruited from the cardiac ward of     a tertiary public hospital in Singapore. They will be randomly assigned to the control group,     or experimental group A (HOM-HEMP without App) or the experimental group B (HOM-HEMP with     App). A research nurse will be delivering the HOM-HEMP to the participants in the     experimental groups, while another research assistant who is blinded to participants' group     assignment will be responsible for data collection. Data will be collected at baseline, at 6     weeks immediate after the intervention, and at 3 and 6 months from the baseline. At the end     of the programme, a process evaluation will be conducted to assess the acceptability,     strengths and weaknesses of the HOM-HEMP based on the participants' perspectives.      Discussion: It is expected the proposed RCT will make a contribution to knowledge development     of the effectiveness of the HOM-HEMP and the active ingredients of the programme.   "
13538|NCT03108222|"     Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at     risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P     homeostasis due to progressive loss of kidney function are primary driving forces behind     cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an     critical aspect in P homeostasis but has been understudied, particularly in the early stages     of CKD progression. This study aims to determine P absorption in patients with moderate CKD     compared to healthy adults.   "
13553|NCT03108027|"     This is a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over     study in asthma patients. The study will consist of a 14-day screening period, followed by a     14-day run-in period, and a treatment epoch which consists of three treatment periods, with a     minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out     period. The duration of each treatment period may be extended up to a duration of 18 days if     needed for operational reasons. The third treatment period will be followed by a Study     Completion evaluation at 1-7 days following the last dose. The treatment periods will be     separated by wash-out periods of 14 to 21 days duration.   "
13554|NCT03108014|"     This study will help us learn more about how early infant diet may influence child's growth     and development at age 14.   "
13555|NCT03108001|"     This study will help us learn more about how a mother's health during pregnancy may influence     her child's growth and development later in life.   "
13539|NCT03108209|"     Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult     patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.      Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients     with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.      These treatments are associated with a lot of adverse reactions, which may lead to dose     reduction, temporary interruption or discontinuation of treatment, which often leads to     treatment failure or a decrease in treatment compliance.      The most commonly reported adverse reactions (> 30%) with Vemurafenib are arthralgia, rash,     photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse     events (> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia,     photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate     aminotransferase, blood creatine phosphokinase elevation and vomiting.      The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in     combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.      The use of optimal photoprotection including the repeated daily use of external     photoprotection products is currently recommended for all patients receiving treatment with     vemurafenib or with the combination of vemurafenib and cobimetinib.   "
13540|NCT03108196|"     Bladder cancer is a common malignant tumor of the urinary system, radical resection plus     urinary diversion is the first choice of treatment for muscle invasive bladder cancer.     Urinary diversion of surgical options related to patient' survival and quality of life.      In 1988, Hautmann firstly reported an orthotopic urinary diversion method: Hautmann     neobladder. As the urine can be controlled from the original urethra, the patient's quality     of life has been greatly improved, so the new bladder surgery gradually accepted and welcomed     by urologists and patients. However, in order to achieve low-pressure and large-volume     storage capacity of the urine reservoir, the 40-70cm long interception of terminal ileum need     to be detubularized. Only after split, folded, re-stitched and a series of treatment, the     intestinal can be used. Such complicated procedures make so many urologists give it up. In     addition, the interception of the long ileum may lead to reduced absorption of vitamin B12     which caused anemia, metabolic acidosis, intestinal dysfunction. Not only that, as time goes     by, this kind of neobladder will be unlimited expansion and resulting in a serious increase     in residual urine volume, hydronephrosis, or even the occurrence of neobladder spontaneous     rupture.      In 2000, professor Chunxiao Liu invented detaenial sigmoid neobladder, this surgical method     overset the traditional intestinal detubularization approach, which detached the serosal     layer with smooth muscle from the bowel without split it. This kind of neobladder is easier     to construct and have less impact on intestinal function. So far, it has been implemented for     more than 600 cases in Zhujiang hospital, the age of patients range from 9 months (bladder     rhabdomyosarcoma) to 84 years old.      So far as now, no multicenter prospective clinical study on orthotopic urinary diversion has     been performed worldwide, neither the head-to-head studies on detaenial sigmoid neobladder     and ileal neobladder.      Our project is going to perform a multicenter randomized controlled trial for these two     neobladder methods and look forward to assess the safety and efficacy of these two procedures     which provide an objective basis for the patients undergoing orthotopic urinary diversion in     the future.   "
13541|NCT03108183|"     The purpose of the study is to evaluate the longterm treatment results after micro-surgical     root resection of teeth with post and core and crown.   "
13542|NCT03108170|"     Pregnant participants will be recruited at the obstetrics outpatient clinic during their     visits 4 weeks before the due date. They are randomized into two groups. The first group will     be educated to do digital perineal massage. They will be also educated to do pelvic floor     muscle exercises and will receive the usual education program for strengthening the pelvic     floor. The second group will receive the usual education program for strengthening the pelvic     floor. Occurrence of perineal laceration will be reported at time of delivery.   "
13543|NCT03108157|"     Clinical trial about the effect of endometrial scratch on pregnancy rates in patients     undergoing a treatment with in-vitro fertilization with donor eggs, when doing the     endometrial biopsy during the cycle prior to the embryo transfer.   "
13544|NCT03108144|"     Tobacco and alcohol use present multiplicative risk for aerodigestive cancers. Reducing     alcohol consumption improves smoking cessation outcomes and reduces cancer risk. Risky     alcohol consumption and smoking are often treated separately despite concurrent treatment     potentially leading to better outcomes for each. However, no rapidly scalable program exists     for combined interventions in primary care clinics spread across wide geographic areas. This     cluster randomized trial aims to report on the effects of a novel clinical decision support     system (CDSS) on intervention rates by primary care practitioners addressing risky alcohol     use in a smoking cessation program.      The investigators will be implementing a clinical decision support system (CDSS) in 221     primary care sites participating in the Smoking Treatment for Ontario Patients (STOP) program     across Ontario, Canada. Sites will be blindly allocated to one of two clinical decision     support systems guiding practitioners to provide a risky alcohol use intervention to smokers     attempting to quit using nicotine replacement therapy (NRT). Risky alcohol use is defined as     drinking above the Canadian Cancer Society's low-risk drinking guidelines. Primary analysis     will measure the proportion of risky drinkers offered an alcohol intervention in each CDSS     arm at baseline. Patients will be contacted by phone or email to track smoking cessation and     alcohol consumption rates at 6- and 12-month follow up.      Upon completion of the trial, the effect of different clinical decision support systems on     practitioner behavior, and on client tobacco and alcohol use, will be discussed. If the CDSS     successfully promotes SBIRT for risky alcohol use in a primary care setting and/or improves     patient-level outcomes, including smoking cessation rates and alcohol use reduction, this     tool can be used as a model for other web-based behavior change interventions integrated into     primary care practice.   "
13545|NCT03108131|"     The goal of this research study is to learn if cobimetinib and atezolizumab can help to     control advanced rare tumors. The safety of the drugs will also be studied.   "
13551|NCT03108053|"     Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in     ureteroscopy and recommended its routine use. However, the necessity of SGW placement in     endourological procedures lack evidence and is being suggested as an expert opinion. Present     study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral     stones with semi-rigid ureteroscopy (s-URS).      For this purpose patients with ureteral stones are being stratified according to ureteral     stone location and prospectively randomized into two groups' according to SGW usage or not in     s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr     (Olympus) and laser. Chi-square and student t-test were used for comparing data.   "
13552|NCT03108040|"     Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal     mortality and morbidity and is characterized by complex hemodynamic changes involving     placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence     of these modifications in relation to other hemodynamic changes of the fetal arterial and     venous circulations is unknown.      The aim of this study was to evaluate cardiac function and other hemodynamic changes in a     group of fetuses with IUGR and clinical impact on perinatal outcome .   "
13579|NCT03107689|"     The purpose of this project is to evaluate the case characteristics of patients who receive     intravenous lipid emulsion therapy. Previous literature to date has focused on animal studies     or has been primarily limited to case reports or small case series. This prospectively     collected data set will permit a much more detailed description of the use of lipid, its     potential benefits, and potential harms.   "
13556|NCT03107988|"     Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib.     In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single     agent and in combination with chemotherapy in patients with relapsed/refractory     neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I     3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6     patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be     initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort     A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).   "
13557|NCT03107975|"     This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell     (hAEC) transplant in the management of children with spastic cerebral palsy.   "
13558|NCT03107962|"     The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade     pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma.   "
13559|NCT03107949|"     An early feasibility study to investigate the safety and feasibility of the Lungpacer     Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the     diaphragm of patients who have been intubated and invasively mechanically ventilated for > or     = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not     hypervolemic during the latest SBT.   "
13560|NCT03107936|"     The goal of the proposed research is multi-step, through a series of sub-studies that build     on each other as part of a comprehensive line of investigation into the use of interactive     mobile games as interventions and/or data collection tools around smoking and tobacco     products in teens.   "
13561|NCT03107923|"     This study evaluates whether a preoperative assessment of myocardial contractile reserve by     tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI)     can enhance the patient selection and risk stratification to transcatheter aortic valve     implantation.   "
13562|NCT03107910|"     The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black     men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches     include addressing stigma related concerns and structural barriers in order to increase     HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an     intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this design     includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with     at-home, self-administered HIV and STI test kits.   "
13563|NCT03107897|"     In this pilot study, investigators aim to identify patients undergoing TAVR who are at     elevated risk for adverse clinical events due to decreased exertional capacity and physical     deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy     is safe in these patients. Lastly, investigators aim to assess the efficacy of     prehabilitation        1. to improve physical functioning by the time of TAVR and to sustain benefit through 30          days post-procedure; and        2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and          quality of life.   "
13564|NCT03107884|"     Muscle atrophy and insulin resistance are common after bed rest in healthy older adults.     Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss     in insulin resistance adults though the mechanisms are not fully known. Metformin used as a     preventive strategy to maintain muscle and metabolic health in bed ridden older adults has     not been investigated.   "
13575|NCT03107741|"     Metabolic syndrome (MetS) is a serious public health problem in Hong Kong and worldwide.     Older adults, the age group with the highest prevalence of MetS, may prefer specific exercise     modalities that are suitable for their regular participation to manage MetS. This project     aims to evaluate the effectiveness of Tai Chi, a very suitable exercise for older adults, to     alleviate MetS in older population   "
13576|NCT03107728|"     The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities)     study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to     achieve greater levels of physical and self-reported function compared with conventional     (CONV) AFOs for those ambulating at or above the independent community level of ambulation.   "
13565|NCT03107871|"     The overall goal of this study is to determine the clinical benefit and safety of antiviral     therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants.     We will conduct a multi-center double-blind randomized placebo-controlled trial to determine     whether hearing-impaired infants with asymptomatic cCMV have better hearing and language     outcomes if they receive valganciclovir antiviral treatment. We will also determine the     safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired     infants. This study will be unique in that the cohort enrolled will only include     hearing-impaired infants with asymptomatic cCMV.      Aim 1: Test the hypothesis that asymptomatic CMV-infected hearing impaired infants treated     with antiviral valganciclovir will have better hearing and language outcomes compared with     untreated CMV-infected hearing impaired infants.      Aim 2: Evaluate the safety of antiviral valganciclovir therapy for asymptomatic CMV-infected     hearing impaired infants.      Aim 3: Evaluate the pharmacokinetics (pK) of valganciclovir using pharmacometrics modeling to     develop a population pK model.   "
13566|NCT03107858|"     Renal transplantation is now recognized as a treatment of choice for patients with chronic     renal failure with end-stage renal disease. Renal transplantations are associated with better     quality of life, better cost/benefit ratio, and possibly longer survival. Significant changes     in blood pressure are common throughout the surgical procedure for kidney transplantation.     All efforts are made to maintain an appropriate level of blood pressure by using an adequate     intravascular volume and vasopressor administration. All efforts are made to maintain an     appropriate level of blood pressure by using an adequate intravascular volume and vasopressor     administration. All efforts are made to maintain an appropriate level of blood pressure by     using an adequate intravascular volume and vasopressor administration. All efforts are made     to maintain an appropriate level of blood pressure by using an adequate intravascular volume     and vasopressor administration.   "
13600|NCT03107416|"     The purpose of this study is to test the safety of Bumetanide , at different doses to find     out what effects, if any, it has on people who undergo tumor TAE as part of their regular     care. Bumetanide is a commonly used medication to reduce the amount of water in the body.   "
13567|NCT03107845|"     The research project investigates in a randomized controlled trial the effectiveness as well     as moderating and mediating factors of psychometric feedback to therapists. In the intended     study a total of 423 patients, who applied for a cognitive-behavioral therapy at the     psychotherapy clinic of the University Trier and suffer from a depressive and/or an anxiety     disorder (SCID-interviews), will be included. The patients will be randomly assigned either     to one therapist as well as to one of two intervention groups (CG, IG2). An additional     intervention group (IG1) will be generated from an existing archivale data set via propensity     score matching. Patients of the control group (CG; n = 85) will be monitored concerning     psychological impairment but therapists will not be provided with any feedback about the     patients assessments. In both intervention groups (IG1: n = 169; IG2: n = 169) the therapists     are provided with feedback about the patients self-evaluation in a computerized feedback     portal. Therapists of the IG2 will additionally be provided with clinical support tools,     which will be developed in this project, on the basis of existing systems. Therapists will     also be provided with a personalized treatment recommendation based on similar patients     (Nearest Neighbors) at the beginning of treatment.      Besides the general effectiveness of feedback and the clinical support tools for negatively     developing patients, further mediating and moderating variables on this feedback effect     should be examined: treatment length, frequency of feedback use, therapist effects,     therapist's experience, attitude towards feedback as well as congruence of therapist's and     patient's evaluation concerning the progress.      Additional procedures will be implemented to assess treatment adherence as well as the     reliability of diagnosis and to include it into the analyses.   "
13568|NCT03107832|"     CONTEXT AND AIMS: The aim of the study is to compare patients satisfaction of thoracic     epidural and general anesthesia procedures in patients undergoing elective laparoscopic     cholecystectomy. SETTINGS AND DESIGN: This comparative randomized study was conducted Abant     Izzet Baysal University hospital between October 2012 and 2014.Forty-five patients who were     under American Society of Anesthesiologists I-II classification and were scheduled for     elective laparoscopic cholecystectomy were included in the study. SUBJECTS AND METHODS: All     participant was separated, two group. In epidural anesthesia group(Group E), a catheter was     installed and received 20 mg lidocaine hydrochloride, 15 mg bupivacaine, and 25 mg fentanyl     citrate adjusted to 10 cc with normal saline to be injected by the epidural catheter.     Bispectral index -controlled sedation was provided. In general anesthesia group(Group G), and     induction was managed using 1.5 mg/kg fentanyl and 2 mg/kg propofol; 0.5 mg/kg rocuronium and     sevoflurane in a 50% oxygen/air mixture was used. Blood gas analysis monitoring was performed     in the 30th minute before and after pneumoperitoneum. Surgical satisfaction was recorded     after pneumoperitoneum. After the operation, 75 mg diclofenac sodium was applied for patients     with Numeric Rating Scale scores higher than 4. STATISTICAL ANALYSIS USED:Data analysis was     performed using the Statistical Package for the Social Sciences version 18 software (SPSS,     Chicago, IL, US). Descriptive variables, such as age, ASA classification, weight, height,     mean arterial pressure (MAP), HR, and duration of surgery, are given as mean ± standard     deviation, and an independent sample t-test (normal distribution) as well as a Mann-Whitney U     test (not a normal distribution) were used for continuous variables. To compare the normal     and abnormal distributions in the groups, simple t-test, and Wilcoxon test was used,     respectively. The results were considered statistically significant at p-values <0.05.   "
13569|NCT03107819|"     The investigators are seeking to enroll 8 children ages 2-18 already undergoing upper     endoscopy. For the purposes of research, a peripheral blood and clean catch urine specimen     will be obtained to measure plasma and urine metabolomics. The data will be used to determine     if there are any key differences in the metabolite profile of subjects found to have     eosinophilic esophagitis (EoE) versus non-EoE subjects. Once these metabolites are     identified, the investigators will seek to enroll many more subjects for a validation phase.   "
13570|NCT03107806|"     To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose     levels in patients hospitalized for acute coronary syndromes   "
13571|NCT03107793|"     The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled     with early endoscopic assessment versus a clinically driven (routine care) approach in     achieving endoscopic response.   "
13572|NCT03107780|"     This phase 0/I trial studies the side effects and best dose of MDM2 inhibitor AMG-232 in     treating patients with glioblastoma that is newly diagnosed or has come back. MDM2 inhibitor     AMG-232 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
13573|NCT03107767|"     There is a high incidence of re-operations after surgery for ankle fractures. According to     the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is     almost 10%.      We are conducting a study on the efficacy of an evidence based algorithm for the treatment of     ankle fractures.   "
13574|NCT03107754|"     For pain relief during a first trimester surgical aspiration, most providers use the     paracervical block, either alone or in combination with other pain control techniques. Some     providers use buffered lidocaine due to a belief that it decreases pain. Others use plain     lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain     lidocaine in a two site injection. Few studies have compared buffered versus nonbuffered     lidocaine for paracervical blocks during first trimester uterine aspirations. This study     seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for     paracervical blocks.   "
13577|NCT03107715|"     Background: Exclusive breastfeeding through age 6 months is the optimal infant feeding method     due to lifesaving benefits for children and mothers (AAP, others). Exclusive breastfeeding     in-hospital is critical because in-hospital formula supplementation doubles risk of     non-exclusive breastfeeding at 30-60 days (Chantry et al, 2014). While breastfeeding     initiation rates have increased at our inner-city Baby Friendly - designated maternity     hospital, exclusive breastfeeding lags. CDC mPINC data (maternity practices in infant     nutrition and care, 2015) demonstrate this is a national problem, with >50% of surveyed     hospitals endorsing supplementation of 10-49% of breastfed infants.      Study Objective: The study objective is to evaluate acceptance/satisfaction of 2 prenatal     interventions (breastfeeding champion and positive messaging) and to determine if these     affect exclusive breastfeeding intention and practice.      Methods: In this prospective intervention study with follow-up chart review, we will pilot     two 5-minute-long iPad-based interventions for 1 month each in obstetrical clinics, following     a required 28-week obstetrical visit breastfeeding education. All expectant mothers     (including 14-17 year olds with guardian) are eligible. Outcomes are acceptance (enrollment     rate), satisfaction (Likert-based), impact on exclusive breastfeeding intention (pre/post     query) and secondarily impact on exclusive breastfeeding in-hospital and at 2 weeks.   "
13578|NCT03107702|"     Bariatric surgical procedures are associated with low short-term mortality and may be     associated with long-term reductions in all-cause, cardiovascular, and cancer-related     mortality. This surgeries are major surgeries include risk of mortality still.      Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant,     antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and     analgesic. Melatonin is neurohormone with the profile of a novel hypnotic-anesthetic agent.      The purpose of this study is to investigate the preoperative, perioperative and postoperative     melatonin levels in bariatric surgery under general anesthesia and to investigate the     relationship between melatonin level and analgesia requirement.   "
13580|NCT03107676|"     College students from physical therapy department will be assigned into four groups.     Participants will be tested for trunk extensors endurance and will be given endurance     training program to do at home for 6 to 8 weeks. Spinal mobility and lower extremity mobility     will be measured. Isokinetic outcome measures for extension and flexion at two different     speeds will also be measured at baseline, after 6 and 8 weeks.   "
13581|NCT03107663|"     The purpose of the study is to determine the safety and feasibility of 89Zr-Df-IAB22M2C an     immunoPET tracer, to evaluate the best time point and mass dose for imaging; its     pharmacokinetic (PK) and biodistribution properties; and its ability to detect CD8+ T cells     and other immune biomarkers from optional biopsies.   "
13582|NCT03107650|"     Elaboration of a preoperative prediction model of the quality of the mesorectum and the     involvement of the circumferential margin in patients with mid-low rectal cancer who undergo     laparoscopic anterior rectal resection.      In a second phase the investigators will study the utility of the prediction model in     classifying patients with high risk of suboptimal quality of mesorectum and/or positive     circumferential margin. Patients with high preoperative risk will undergo a transanal total     mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal     excision. The investigators finally will compare pathological outcomes ( quality of     mesorectum and circumferential margin), survival and recurrence between the two groups.   "
13583|NCT03107637|"     The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined     etiology. The following etiological workup is required in this setting: head CT or MRI,     12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24     hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT     angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not     to be required.      However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is     a major aortic source of embolism, as supported by numerous well conducted studies. The     European Association of Echocardiography considers that TEE is the gold standard for the     diagnosis and the characterization of aortic atheroma. It is also the method of choice for     the diagnosis of infectious endocarditis.      The aim of this work was to evaluate the rate of patients with a therapeutic modification     induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with     ESUS at our institution stroke unit.   "
13584|NCT03107624|"     This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test     the hypothesis that different clinical presentations before AMI onset can affect coronary     plaque morphologies in AMI patients .   "
13585|NCT03107611|"     To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of     reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate     Atopic Dermatitis.      To establish superiority of each active treatment over the placebo.   "
13586|NCT03107598|"     Comparison between colloid preload and crystalloid co-load in cesarean section under spinal     anesthesia.        1. The primary outcome was the incidence of hypotension        2. Secondary outcomes included the incidence of severe hypotension, total ephedrine dose,          nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery          blood gas analysis   "
13587|NCT03107585|"     The investigators included prospectively 35 patients undergoing an intermediate cervical     block under ultrasound (GP1) before a thyroidectomy ,compared to a group of 35 patients     without a block (GP2).   "
13588|NCT03107572|"     The study consist of evaluation in cardiac surgery with cardiopulmonary bypass (CPB) setting     the ability of PCO2 derived variables (ΔPCO2, ΔPCO2/C(a-v)O2 ratio), compared to lactate and     ScVO2 to predict major postoperative adverse events.   "
13615|NCT03107221|"     A pilot study exploring whether individuals receiving usual treatment (CBT) from the     specialist NHS Tayside Eating Disorders Service and accessing the online self-help Smart     Eating programme have improved treatment outcomes compared to those receiving usual     treatment only. The study will also explore acceptability of the Smart Eating self-help     programme via a feedback questionnaire.   "
13589|NCT03107559|"     It can be suggested that sympathetic tonus increase and pain, caused by the removal of the     effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose     of this study is; To correlate the VAS value at the time of return of epidural analgesia with     the PI values at that time and, to test the possibility of using PI variants as an objective     tool for predicting pain initiation time and assessing pain.   "
13590|NCT03107546|"     Syndactyly is the most common hand abnormality in children. During development, two or more     fingers do not separate in the usual way and remain connected by skin. Surgery is needed to     separate the fingers. Usually, it is performed between 6 months and 3 years of age, depending     on the severity of the syndactyly. During the surgery, the fingers are separated; however,     there isn't enough skin to completely cover the fingers once they are separated. There are     two areas on the fingers that need to be covered after separation, and there is a standard     method, and now a new technique to cover these areas.      The standard current technique that surgeons use to cover the newly separated fingers is to     apply a small section of the patient's own skin taken from a different area of their body     (this is known as a skin graft).      A new technique called Hyaluronic acid matrix (Hyalomatrix®) is a U.S. Food and Drug     Administration (FDA) approved, commercially available, skin graft substitute that is     currently being used both in the US and in Europe. The Hyalomatrix (or skin graft substitute)     is sutured into place using a stitch on each corner, over the areas left without skin     covering during the surgery.      The purpose of this study is to compare effectiveness, wound healing, scar formation and     potential associated complications of the current skin graft technique with the new technique     called Hyalomatrix (or skin graft substitute) following surgery.   "
13591|NCT03107533|"     Analysis of video encounters between providers, patients, and families will be used to     develop a shared decision making tool for patients deciding between surgery and observation     for scoliosis treatment.   "
13592|NCT03107520|"     This study evaluates the feasibility and utility of contrast-enhanced ultrasound to provide     real-time assessment of blood flow to the femoral head in infants undergoing surgical     reduction for developmental dysplasia of the hip.   "
13601|NCT03107403|"     The aim of the study is to investigate a possible role of dreaming in emotion regulation     testing whether dreaming of a close relative recently deceased is correlated with a positive     evolution of the bereavement process   "
13593|NCT03107507|"     Over the last three decades, several tools have been developed to enhance the detection and     treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as     a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as,     levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal     population, offering the potential for seizure treatment with a significantly better     side-effect profile.      Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has     been in clinical use for almost a decade in adults and older children with good efficacy, an     excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved     and used for treatment of seizures in infants starting one month of age since 2012.      The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a     first-line drug in control of neonatal seizures. The investigators monitor the efficacy     through assessment of frequency of seizures before and after drug administration, amplitude     integrated EEG changes in background activity and seizure frequency in participants, duration     taken for participants to be seizure free and short term neurodevelopmental outcome and EEG     at 3 months of age   "
13594|NCT03107494|"     Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic     bronchitis.   "
13595|NCT03107481|"     The purpose of the current study is to compare the analgesic efficacy of intravenous     acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.   "
13596|NCT03107468|"     This is a clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive     treatment program regarding pain and function before and after treatment between a group     receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education)     for five weeks and another group receiving non-surgical conventional standard treatment     (drugs for pain relief, epidural steroid injection treatment, and physical therapy).      The trial will be conducted through international cooperation between Mayo Clinic in the     United States and Mokhuri Oriental Medicine Hospital in Korea. All subjects in Korea and the     US will be selected based on the same inclusion criteria and exclusion criteria. All subjects     in the treatment arm will receive the same treatment in Korea and the US. In collaboration     and with the support of Mayo Clinic's Department of Integrative Medicine and Health, and to     ensure treatment consistency between Korea and the US, an acupuncturist from the USA will     travel to Korea and train on-site for one month in Mokhuri hospital.      The trial subjects who agree to participate in the clinical trial after providing informed     consent will receive the required examinations and tests according to the clinical trial     plan. If they are appropriate for this clinical trial and eligible based on the Inclusion and     exclusion criteria, they will be randomly assigned to the group that will undergo the focused     Mokhuri intensive treatment program and to the group that will receive non-surgical     conventional treatment on their second visit. All the subjects in this study will be educated     regarding the study procedure and scheduled visits and will participate in the allocated     treatments for five weeks. Afterwards, clinical outcomes of both groups will be evaluated     after end of the treatments from between a week and five weeks (within +7 days). The clinical     trial ends after the follow-up evaluations that will take place 12 weeks, 24 weeks, 48 weeks,     and 96 weeks after the end of the treatment evaluation.   "
13597|NCT03107455|"     Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of     papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in     MitraClip registries. Our group has recently published the Spanish experience with MitraClip     in acute MI, but only 5 patients could be collected. However, the results of our initial     experience are highly encouraging since patients performed well in such life-threatening     condition. In order to expand the information of the device in this condition, our aim is to     start a multinational registry in Europe.   "
13608|NCT03107312|"     Recent observations in Germany revealed above-average high proportions of refugees affected     by infectious diseases of public health significance. Scrutiny of the vaccination status     showed sizeable presence of seronegative subjects, with conspicuously higher prevalence among     children and adolescents, thus indicating urgent necessity of i) rapid identification of     carriers of vaccine-preventable diseases and ii) adjustment of protection against such     infections to European Standards. Rapid immune status check needs comprehensive diagnostic     tool permitting simultaneous assessment of seropositivity. Validation of such tools requires     comparisons of the immune status of subjects with known vaccination history with that of     migrants with incomplete or missing health and vaccination records.   "
13609|NCT03107299|"     Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence     of this treatment decreases the control of the disease and the effectiveness of the     associated treatments.      The aim would be to study the observance of patients with RA and to be able to propose     adequate solutions favoring patient compliance and thus the stability of the pathology.      For this purpose, 3 methods of communication have been put in place to encourage adherence:     usual care by the rheumatologist, sms sending or pharmaceutical maintenance.   "
13598|NCT03107442|"     Patients with Systemic Lupus Erythematosus (SLE) have increased arterial stiffness, which     leads to cardiovascular diseases (CVD) of arteriosclerotic origin, which are the main cause     of mortality in these patients. Exercise is a modifiable factor that reduces cardiovascular     mortality and associated risk factors in the general population. Preliminary studies suggest     that exercise may improve endothelial function and lipid profile in patients with SLE.     However, whether meeting the international physical activity guidelines from the American     College of Sports Medicine (ACSM; i.e. ≥150 min / week of moderate to vigorous intensity     physical activity) can improve arterial stiffness (subclinical atherosclerosis marker) and     inflammation is unknown.      The primary aim of this study is to assess the effect of an exercise program based on meeting     the ACSM physical activity guidelines on arterial stiffness and inflammation in patients with     SLE.      The secondary aim is to assess the effect of an exercise program based on meeting the ACSM     physical activity guidelines on endothelial function, oxidative stress, as well as other     cardiometabolic risk factors, physical fitness, health-related quality of life, and other     psychosocial outcomes.      Our hypothesis is that meeting the ACSM guidelines will improve arterial stiffness and     inflammation in patients with SLE.      The study is a non-randomized clinical trial. To minimize selection bias, participants in the     intervention and control groups will be matched by age, BMI, and disease activity (SLEDAI),     which are important contributors to arterial stiffness.   "
13599|NCT03107429|"     Perioperative vision loss following laparoscopic colorectal surgery is rare but has been     reported. Studies show Trendelenburg positioning during surgery can produce a significant     rise in the IOP, and this rise is thought to be a possible factor. Acetazolamide decreases     IOP by reducing the formation of aqueous humour.      Aims:      To investigate if acetazolamide reduces the IOP rise resulting from Trendelenburg     positioning.      Methods:      A randomised cross-over blinded pilot study. Nine healthy volunteers were randomised to start     with the placebo or Acetazolamide with a 5 days' washout period. Baseline IOP was measured on     both days. After 1.5 hours of taking the medication, volunteers lay head-down at 17 degrees'     for 4 hours and IOP measurements repeated. This reading was subtracted from the baseline to     give a 'change in IOP'.   "
13602|NCT03107390|"     NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new     marker for biological inflammation, especially in rheumatology.      Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study,     the OPERA study where in a population of 12 patients showed an increase in NT-proBNP     correlated with the biological and endoscopic activity of the disease. This larger study is     therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.   "
13603|NCT03107377|"     Phase 2B double-blind placebo-controlled efficacy trial of Amphora® gel for the prevention of     acquisition of urogenital Chlamydia trachomatis infection   "
13604|NCT03107364|"     Medical and surgical innovations have allowed to shorter length of hospital stay (LOS). We     assume that hospitals with uncontrolled reduction in LOS may expose patients to unsafe care.     At the institutional level, a dynamic analysis of LOS evolution over time could clarify the     existence of a link with the risk of readmission.   "
13605|NCT03107351|"     This study aims to validate the possibility to track cardiac contractility changes with a new     technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared     echocardiography.   "
13606|NCT03107338|"     The objective of this prospective randomized double-blind study was to evaluate the effects     of the preoperative administration of dexketoprofen trometamol (DKT) on the pain perceived by     patients after oral surgery for implant placement.      Materials and Method: Single oral doses of 25 mg DKT or PLACEBO were administered 15 minutes     before the performance of conventional implant surgery to assess the influence of the DKT on     pain as reported by the patients. One hundred patients who required single-implant treatments     were randomly distributed into one of the two blinded groups following a preliminary     examination. Fifteen minutes before surgery, the patients in the test group were given 25 mg     DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo     (PLACEBO group). The patients' pain intensities were measured using a subjective visual     analogue scale of 100 mm in length, and pain was measured over a period of 7 days.     Inflammation was assessed using a 5-point Likert scale on days 2 and 7.   "
13607|NCT03107325|"     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear     medicine provides potentially life-saving information regarding physiological processes, and     is of particular value in children where the rapid and unequivocal diagnosis of pathological     concerns is essential for the health of these patients. The overall objective of this     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible     while maintaining excellent diagnostic quality of nuclear medicine images. This is     particularly important since children are at increased risk due to the enhanced     radiosensitivity of their tissues and the longer time-period over which radiation effects may     manifest. Current dosimetric estimations in children are based on either animal biokinetic or     pharmacokinetic data from adults due to paucity of data that exists for children. This     situation will be improved through the following specific aims:        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age          groups scheduled for routine nuclear medicine studies for F-18 fluorodeoxyglucose (FDG),          a radiopharmaceutical commonly used in pediatric nuclear medicine        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and        -  Generate biokinetic models to be used in subsequent dosimetric models for the          optimization of pediatric nuclear medicine procedures.      Since inadequate pharmacokinetic data currently exist in these patients, the investigators     will use the data acquired in this study to establish PK models applicable to different age     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric     nuclear medicine make age-dependent adjustments only for patient size and anatomical     differences, while time-dependent kinetics from adult PK models are assumed due to the lack     of kinetic data for children. The data obtained from this study will make it possible for the     first time to determine how the PK in pediatric patients differs from adults. This will be     done for F-18 fluorodeoxyglucose (FDG), a radiopharmaceutical commonly used for pediatric     nuclear medicine imaging. The overall hope is that results will allow the molecular imaging     community to implement pediatric dose-reduction approaches that substantially improve upon     current guidelines pointing to future technological advances that could yield even greater     dose-reduction while simultaneously improving diagnostic image quality.   "
13649|NCT03106779|"     The purpose of this pivotal study is to compare the efficacy of ABL001 with that of bosutinib     in the treatment of patients with CML-CP having previously been treated with a minimum of two     prior ATP-binding site TKIs with BCR-ABL ratios ≥ 1% IS at screening.   "
13610|NCT03107286|"     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear     medicine provides potentially life-saving information regarding physiological processes, and     is of particular value in children where the rapid and unequivocal diagnosis of pathological     concerns is essential for the health of these patients. The overall objective of this     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible     while maintaining excellent diagnostic quality of nuclear medicine images. This is     particularly important since children are at increased risk due to the enhanced     radiosensitivity of their tissues and the longer time-period over which radiation effects may     manifest. Current dosimetric estimations in children are based on either animal biokinetic or     pharmacokinetic data from adults due to paucity of data that exists for children. This     situation will be improved through the following specific aims:        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age          groups scheduled for routine nuclear medicine studies for Tc-99m          mercaptoacetyltriglycine (MAG3), a radiopharmaceutical commonly used in pediatric          nuclear medicine        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and        -  Generate biokinetic models to be used in subsequent dosimetric models for the          optimization of pediatric nuclear medicine procedures.      Since inadequate pharmacokinetic data currently exist in these patients, the investigators     will use the data acquired in this study to establish PK models applicable to different age     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric     nuclear medicine make age-dependent adjustments only for patient size and anatomical     differences, while time-dependent kinetics from adult PK models are assumed due to the lack     of kinetic data for children. The data obtained from this study will make it possible for the     first time to determine how the PK in pediatric patients differs from adults. This will be     done for Tc-99m MAG3, a radiopharmaceutical commonly used for pediatric nuclear medicine     imaging. The overall hope is that results will allow the molecular imaging community to     implement pediatric dose-reduction approaches that substantially improve upon current     guidelines pointing to future technological advances that could yield even greater     dose-reduction while simultaneously improving diagnostic image quality.   "
13617|NCT03107195|"     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear     medicine provides potentially life-saving information regarding physiological processes, and     is of particular value in children where the rapid and unequivocal diagnosis of pathological     concerns is essential for the health of these patients. The overall objective of this     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible     while maintaining excellent diagnostic quality of nuclear medicine images. This is     particularly important since children are at increased risk due to the enhanced     radiosensitivity of their tissues and the longer time-period over which radiation effects may     manifest. Current dosimetric estimations in children are based on either animal biokinetic or     pharmacokinetic data from adults due to paucity of data that exists for children. This     situation will be improved through the following specific aims:        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age          groups scheduled for routine nuclear medicine studies for 4 radiopharmaceuticals          commonly used in pediatric nuclear medicine        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and        -  Generate biokinetic models to be used in subsequent dosimetric models for the          optimization of pediatric nuclear medicine procedures.      Since inadequate pharmacokinetic data currently exist in these patients, the investigators     will use the data acquired in this study to establish PK models applicable to different age     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric     nuclear medicine make age-dependent adjustments only for patient size and anatomical     differences, while time-dependent kinetics from adult PK models are assumed due to the lack     of kinetic data for children. The data obtained from this study will make it possible for the     first time to determine how the PK in pediatric patients differs from adults. This will be     done for Tc-99m dimethylsuccinic acid (DMSA), a radiopharmaceutical commonly used for     pediatric nuclear medicine imaging. The overall hope is that results will allow the molecular     imaging community to implement pediatric dose-reduction approaches that substantially improve     upon current guidelines pointing to future technological advances that could yield even     greater dose-reduction while simultaneously improving diagnostic image quality.   "
13611|NCT03107273|"     Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal     haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid     leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their     prognosis, in addition to extrinsic factors depending on the patient himself (age,     comorbidities), intrinsic factors. The cytological evaluation is subject to a certain     subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of     marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in     the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the     expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in     place within the laboratory. However, these studies are based on a static model that studies     the phenotypic characteristics of patients at a given time but does not really reflect     ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would     be an innovative tool for the study of SMD. This project aims to develop and standardize a     system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells     by studying each stage of the differentiation in terms of proliferation, apoptosis and     phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at     diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of     surface markers, in order to identify the quantitative and qualitative abnormalities     associated with the differentiation of haematopoietic progenitors Smart. This should make it     possible to identify diagnostic and prognostic factors in terms of response to treatment,     acutism and survival.   "
13612|NCT03107260|"     There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or     vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an     incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25%     according to the studies.      Age is the main risk of OCDD. The management of this pathology should be early to avoid loss     of autonomy of the patient. Finding a relationship, if it exists, would therefore     significantly improve the mortality and morbidity of the said patient.   "
13613|NCT03107247|"     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear     medicine provides potentially life-saving information regarding physiological processes, and     is of particular value in children where the rapid and unequivocal diagnosis of pathological     concerns is essential for the health of these patients. The overall objective of this     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible     while maintaining excellent diagnostic quality of nuclear medicine images. This is     particularly important since children are at increased risk due to the enhanced     radiosensitivity of their tissues and the longer time-period over which radiation effects may     manifest. Current dosimetric estimations in children are based on either animal biokinetic or     pharmacokinetic data from adults due to paucity of data that exists for children. This     situation will be improved through the following specific aims:        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age          groups scheduled for routine nuclear medicine studies for Tc-99m methylene diphosphonate          (MDP), a radiopharmaceutical commonly used in pediatric nuclear medicine        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and        -  Generate biokinetic models to be used in subsequent dosimetric models for the          optimization of pediatric nuclear medicine procedures.      Since inadequate pharmacokinetic data currently exist in these patients, the investigators     will use the data acquired in this study to establish PK models applicable to different age     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric     nuclear medicine make age-dependent adjustments only for patient size and anatomical     differences, while time-dependent kinetics from adult PK models are assumed due to the lack     of kinetic data for children. The data obtained from this study will make it possible for the     first time to determine how the PK in pediatric patients differs from adults. This will be     done for Tc-99m MDP, a radiopharmaceutical commonly used for pediatric nuclear medicine     imaging. The overall hope is that results will allow the molecular imaging community to     implement pediatric dose-reduction approaches that substantially improve upon current     guidelines pointing to future technological advances that could yield even greater     dose-reduction while simultaneously improving diagnostic image quality.   "
13614|NCT03107234|"     Breast cancer is the leading cause of female cancer and female death by cancer in France.     Despite the improvement in early detection and therapeutic arsenal, the mortality of this     cancer remains high with 11 886 deaths estimated in 2012. Breast cancer is most often a     carcinoma born from the lobular or ductal epithelium and is classified In two main     categories: non invasive and invasive. Invasive breast cancers account for 75% of the cases.     They are usually ductal (75%) and more rarely lobular (25%). The cancer cells are then no     longer circumscribed to the galactophoric canals or glands but have invaded neighboring     tissues. If they are not treated in time, these cancers can then spread: the cancerous cells     will then migrate either by the lymphatic vessels to reach the neighboring ganglia or through     the blood vessels to give metastases in other tissues In the liver, lungs and bones). The     mortality associated with breast cancer is not due to the growth of the primary tumor but     rather to the occurrence of metastases. The study of the mechanisms leading to metastatic     invasion (i.e. migration and invasion) is therefore of considerable importance. The     development of metastases depends on the acquisition by the cancer cells of various     capacities including that of being able to migrate, involving a remodeling of the     cytoskeleton highly dependent on the intracellular calcium (Ca2 +) concentration. Several     types of signals are able to induce mobilization of Ca2 + from the extracellular medium or     endoplasmic reticulum (ER) reserves. At the intracellular level, some of these signals are     generated by inositol (1,4,5) -trisphosphate (IP3) from the activation of G protein-coupled     receptors or certain receptors with tyrosine kinase activity. Has been shown that the     expression, activity and regulation of IP3R receptors (IP3Rs) are involved in the cancerous     processes of many tissues, in particular in the phenomena of proliferation of breast cancer     cells. Overall, altered expression and / or activity of IP3Rs can be used for the survival,     growth, proliferation and migration of cancer cells.      In the laboratory, the investigator showed that regulation of the expression of subtype 3     (IP3R3) by 17β-estradiol (E2) is involved in the growth of the human mammary cancer line     MCF-7. E2 triggers the release of Ca2 + in an IP3-dependent mechanism, while prolonged     exposure to E2 leads to an increase in the expression of IP3R3. At the same time, the     reduction in the expression of IP3R3 cancels the proliferative effect of E2 on MCF-7 cells.     More recently, the investigator has established that IP3R3 regulates the proliferation of     cells of the human MCF-7 mammary cancer cell line via a molecular and functional interaction     with the Ca2 + -dependent BKCa potassium channel. The determination of IP3Rs, including     subtype 3, as a mediator / marker of breast carcinogenesis appears to be a major clinical     issue.   "
13616|NCT03107208|"     A frequent complication in the management of diabetic ketoacidosis (DKA) in children with     type 1 diabetes is rebound hyperglycemia (blood glucose over 180 mg/dL) which increases the     risk of re-developing DKA and can lengthen the hospital stay. The investigators want to study     whether giving the long-acting insulin glargine (Lantus®) early in DKA management (versus     after complete resolution of the DKA) helps prevent rebound hyperglycemia and makes the     transition to insulin injections easier. Participants will also have the option to wear a     continuous glucose monitor (CGM) during the study to help us understand blood glucose control     during and after DKA.   "
13663|NCT03106597|"     The purpose of this study is to evaluate the effect of a third-generation Calcium Channel     Blocker (CCB), manidipine, compared with second-generation Calcium Channel Blocker (CCB),     amlodipine, on the development of peripheral edema using Direct Segmental Multi-Frequency     Bioelectrical Impedance Analysis (DSM-BIA) method in patients with mild to moderate essential     hypertension. Investigator expects this study could show more objective evidence of better     safety of manidipine compared with amlodipine for peripheral edema.   "
13665|NCT03106571|"     This is the first study of pomaglumetad in humans using methamphetamine. The goal of the     study is to determine if pomaglumetad is safe when administered with methamphetamine. If     shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of     pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating     methamphetamine use disorder.   "
13618|NCT03107182|"     Carboplatin, nab-paclitaxel, and nivolumab combination will be administered for three cycles     of three weeks duration each. TORS or RT/CRT will be performed after induction chemotherapy     (i.e. day 64 of therapy). Patients with low risk and small volume tonsillar disease (T1-T2,     non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of     tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck     lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction     chemotherapy will undergo TORS and selective nodal dissection. De-intensified adjuvant RT     will be given for adverse pathologic features. Patients may refuse TORS treatment.      Patients with low risk, who do not qualify for TORS (due to volume of disease or poor     visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction     chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy.      Before induction chemotherapy, patients will undergo examination under anesthesia and direct     laryngoscopy to tattoo and photograph the primary tumor to plan the post-induction resection.     Adjuvant nivolumab will be offered to all patients for 6-months post completion of definitive     therapy (7 doses given as a flat dose of 480mg, every four weeks).   "
13619|NCT03107169|"     Investigators designed an open, two-arm study to compare oral vancomycin with a fecal     microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for     the first Clostridium difficile infection (CDI) episode among hospitalized patients.   "
13620|NCT03107156|"     The overarching objective of this study is to close clinical knowledge and performance gaps     by providing oncology clinicians with the latest advances and emerging research in the     evidence-base and personalized treatment of advanced NSCLC patients. In addition, the     research team seeks to meet quality measures relevant to value-based care delivery through IT     infrastructure and clinical workflow processes. The research team also hopes to gain insights     on clinician practice patterns related to advanced NSCLC, and the correlation between     advanced NSCLC patients reported goals of care and advanced NSCLC patients' fit/frailty     status and treatment decisions.   "
13621|NCT03107143|"     This is a non-blind randomized clinical trial to determine the efficacy of the TurnCare Q2     System for the prevention of sacral region (sacral, coccygeal, and buttocks) pressure ulcers.     TurnCare Q2 System has 2 main components: 1. An Inflatable Skin Perfusion Enhancement Surface     and 2. An Adaptive Pressure Controller. The Skin Perfusion Enhancement Surface has a patented     design that accommodate human anatomy in the sacra region. The Adaptive Pressure Controller     is powered by APSAR technology that provides patient specific pressure relieve in the sacral     region.   "
13622|NCT03107130|"     This retrospective descriptive study is to determine what proportion of Cincinnati     Urogynecology Associates patients who underwent surgical management for stress urinary     incontinence (SUI) would qualify for a basic office exam (BOE) alone, using the inclusion and     exclusion criteria of the Value of Urodynamic Evaluation (VALUE) trial, and thus could have     potentially had Urodynamic studies (UDS) omitted from their preoperative workup.   "
13623|NCT03107117|"     Due to the unmet needs of substance abuse treatment among court involved but     non-incarcerated (CINI) adolescents and their parents, reaching and engaging CINI adolescents     in intervention programs addressing marijuana use is important given the significant risk     that continued substance use poses for re-arrest and detention. This study will examine the     feasibility of implementing one potential model for increasing access to substance use     interventions in a juvenile justice setting by using: 1) a computer- assisted intervention     addressing marijuana use for adolescents, and 2) a computer program on strategies to improve     management of teens who misuse drugs for parents.   "
13624|NCT03107104|"     Compare the image quality of the fundus autofluorescence and fluorescein angiography   "
13625|NCT03107091|"     Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients     with refractory ascites.   "
13626|NCT03107078|"     For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the     Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is     not satisfied. Investigators established a novel classification of TAO for the first time to     assess more precisely for better personal treatment.   "
13712|NCT03105960|"     the study about herbal mouthwash. it is clinical trial .the investigator will compare between     chlorhexidine mouthwash and garlic with lime juice mouthwash.and their effect on gingival     bleeding and plaque and salivary bacteria.   "
13627|NCT03107065|"     This is a pilot, open-label, and single-center, single-treatment prospective evaluation of     the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to improve     excessive sweating of the axilla(s).      In this study, Temporary Relief is defined as improvement on the DLQI.      Twenty male and female subjects between 18 and 50 years old will be enrolled. A total of five     visits are planned for this study.      A punch biopsy will be collected (prior to and post treatment and analyzed to determine the     degree of impact to the tissue after the electrocoagulation treatment.      Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale,     and adverse events reports (observed or reported).      The total length of the study is approximately 4 months.   "
13628|NCT03107052|"     This is a 68-week study to evaluate the long-term safety of fremanezumab in patients with CH.     Patients who complete the pivotal studies and enroll into the current study will visit the     investigational center for IMP administration, safety and efficacy assessments, and blood and     urine collections for pharmacokinetics, immunogenicity (ADAs), and biomarker analyses.     Patients will return to the investigational center for a follow-up visit to evaluate ADAs,     fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant     medications) approximately 7.5 months after the last dose of IMP.   "
13629|NCT03107039|"     This study will address a gap in the literature and advance the field of minority men's     health. Specifically, it will be the first randomized controlled trial of resistance exercise     as a dual intervention for depression symptoms and CVD risk reduction with depressed Black     men.   "
13630|NCT03107026|"     A study to evaluate a drug (dasotraline) on the safety, effectiveness and how well the body     tolerates it, in adults with moderate to severe binge eating disorder   "
13631|NCT03107013|"     This is a single-centre, open-label, non-randomised, single oral dose study in healthy male     subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.   "
13632|NCT03107000|"     Corneal endothelial cells health and pumping function is crucial to permit corneal optical     clarity by keeping cornea in relatively dehydrated state. Corneal endothelial damage has been     associated with most types of intraocular surgery. Trabeculectomy is the standard glaucoma     surgical intervention in management of progressive glaucoma despite of medical therapy which     can be performed in combination with Cataract surgery (Phacoemulsification and IOL     implantation) in patients with cataract-impaired visual acuity.      In this study, the investigators will investigate and compare the corneal endothelial cells     number and health status before and after trabeculectomy vs. combined surgery (at 1 month and     3 months post-op visits) using Specular microscopy which is a non-invasive technique to     access the structure and function of the corneal endothelium by permitting visualization of     the corneal endothelial mosaic to assess the effect of this surgical intervention on corneal     endothelial cells health and number.   "
13634|NCT03106974|"     Airway management in obese patients has to consider that mask ventilation (DMV) risk is     increased and difficult tracheal intubation (DTI) risk may be increased too.      In obese patients, is essential to prevent early arterial oxygen desaturation related to a     reduced functional residual capacity (FRC), atelectasis formation during anesthetic induction     and after tracheal intubation, because oxygenation maintenance is the cornerstone of the     airway management of the obese patient.      Endotracheal intubation is usually required to allow unrestricted surgical approach. The     Macintosh laryngoscope is the standard method. However, sometimes this technique is     ineffective and poorly tolerated by the obese patient.      The Totaltrack™ (MedComflow S.A., Barcelona, Spain) is a hybrid device, between a     supraglottic airway and a videolaryngoscope with an anatomically shaped blade. It allows     fibreoptic visualization of the larynx for tracheal intubation and was developed to aid both     ventilation and tracheal intubation, at the time of anticipated and unanticipated difficult     airway management.      However, despite its use in clinical practice, there are no comparative studies regarding     direct laryngoscopy in obese patients.   "
13635|NCT03106961|"     This study is a single-center, prospective, observational study designed to subjects     presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de     novo lesions.      Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold     implantation ballooning, designed to specifically address the issue of incomplete BVS     expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the     intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold     implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation     to the underlying plaque.   "
13636|NCT03106948|"     The narrowing of Dialysis Fistulae or Grafts is a near universal problem in patients with     end-stage renal disease (ESRD) and requires patients to undergo repeated angioplasty or     mechanical opening of the fistula.   "
13637|NCT03106935|"     The present study is divided into two groups ,one is the patients with subclinical     hypothyroidism who has TPO antibody positive women with TSH concentrations > 2.5 mU/L and     below the upper limit of the pregnancy specific reference range ,another is TPO antibody     negative with TSH concentrations greater than the pregnancy specific reference range and     below 10.0 mU/L.The two groups are randomized into either the LT4 treatment group or control     group by the use of a computer-generated list.      The aim of our study is to determine whether the use of levothyroxine is beneficial in     patients with subclinical hypothyroidism in two groups。   "
13638|NCT03106922|"     A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy,     safety, tolerability, acceptability and palatability of PMF104 compared to a conventional     PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning     the colon.   "
13650|NCT03106766|"     To assess facial acne vulgaris clinical and psychological outcomes by measuring differences     in lesions counts, investigator global assessment, and subjects quality of life scores over 6     months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream     1x in a double blind manner.   "
13639|NCT03106909|"     Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes.     Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as     several issues potentially confound diagnosis. Chest X-ray (CXR), a central component in the     diagnostic work-up, may have limited utility in the early stages as they are often of     suboptimal quality, and infrequently confirm typical diagnostic infiltrates. Blood biomarkers     of the stress-immune response have received considerable attention, but interpretation has     been limited by differing methodologies, including definition of pneumonia. Bacterial     organisms in the oral cavity may also be of relevance as biomarkers of post-stroke pneumonia.     Major challenges facing frontline clinicians are therefore whether to initiate antibiotics;     if so, when and for how long. These issues have antibiotic stewardship implications for     clinicians in terms of potential for under-treatment or over-treatment with antibiotics based     on CXR appearances.      Pulmonary Computed Tomography (CT) could be of value as a radiological reference standard     when pneumonia is suspected after stroke, and enable more rigorous evaluation of the     diagnostic performance of CXR (and other candidate biomarkers) to inform decision-making when     pneumonia is suspected.      The overall primary aim is therefore to investigate the feasibility and reliability of using     pulmonary CT as a radiological reference standard for evaluating suspected pneumonia     complicating stroke. The secondary aims are to explore the diagnostic accuracy of CXR and     blood biomarkers (index tests) when pneumonia is suspected during hospital admission after     stroke using pulmonary CT as a reference standard.   "
13640|NCT03106896|"     Postherpetic neuralgia(PHN) is a chronic neuropathic pain syndrome which persists more than 3     months after the resolution of the acute shingles episode. PHN is a complicated neuropathic     pain that results from the sustained peripheral injury by herpes zoster and its pathological     mechanism in skin and spine has been reported. But the cerebral mechanism is still unclear.     Based on the previous study that has proved the reorganization of cerebral functional     connectivity in pain chronicity, the investigators hypothesize that the process from acute     herpetic pain (AHP) to PHN is also accompanied with the reorganization of functional     connectivity.In the study, the investigators intend to use 7 Tesla functional magnetic     resonance imaging(fMRI) to observe the difference of brain activity and functional     connectivity between acute herpetic pain and PHN. Meanwhile, the investigators examine the     evolution of functional connectivity longitudinally in patients who is suffering from acute     pain, so as to explore the central mechanism of transition to PHN.   "
13641|NCT03106883|"     Biased attention toward negatively valenced information has been considered as a mechanism     for risk and relapse in depression. Those with depression tend to focus their visual     attention first, more frequently, and for longer periods of time, if it connotes negative     (particularly sad) mood. To this end, investigators have recently discovered that this bias     might be modifiable. However, the existing literature is mixed with regard to effectiveness.     The investigators propose in this study a novel approach to modifying attention bias in     depression by using real time feedback with eye tracking technology. The investigators will     examine if, compared to a sham condition, rewarding attention toward positive stimuli results     in improved mood and reductions in attention bias. Following three sessions of either sham     training or active attentional bias training, the investigators hypothesize that participants     in the active training condition will experience a) reductions in negative attentional bias,     and b) to an improved mood state and increased quality of life, compared to those in the sham     training condition.   "
13642|NCT03106870|"     The purpose of the study to prove benefits of adding metformin to insulin for controlling     presentational and gestational diabetes mellitus and improving neonatal outcome.   "
13643|NCT03106857|"     In total, 125 women aged between 20 and 40 years were recruited in this study. Participants     were considered eligible when they met the inclusion criteria of being diagnosed with     functional constipation, as defined by the Rome Foundation. The study was a randomized     controlled trial carried out at Cairo University Hospital.Patients whose BMI exceeded 30     kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation.   "
13644|NCT03106844|"     In this study the investigators will evaluate patients with IBD and and at least 2 confirmed     c.difficile infections who will be undergoing FMT. The investigators will assess patients     before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for     recurrence of c.difficile infection and IBD outcomes.   "
13645|NCT03106831|"     Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can     up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly     acute kidney injury Anesthesiology 2017; 126:85-93). Pituitrin is used as a substitute for     vasopressin in our center, which contains both vasopressin and oxytocin. Oxytocin may     alleviate inflammatory process-associated kidney injury (Peptides 2006;27:2249-57).     Therefore, the investigators hypothesize Pituitrin may be preferable to norepinephrine in the     renal protection of patients with vasoplegic syndrome after cardiac surgery. Moreover, the     serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing     hormone will be measured.   "
13646|NCT03106818|"     Effective pain relief after cardiac surgery has assumed importance with the introduction of     fast track discharge protocols that requires early weaning from mechanical ventilation.     Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of     atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound     has shown to improve early postoperative pain in various surgical procedures.      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in     animal and human models of pain.   "
13647|NCT03106805|"     The optimal interval between pregnancies is debated, but a duration greater than 11-18 months     has been suggested as reducing complications in the subsequent pregnancy. Improved birth     spacing can be a key benefit use of long-acting reversible contraception, but delay to     initiation can still be problematic.So women who have recently given birth can be     cost-effectively targeted for family planning education and engagement because often they are     already connected with health professionals   "
13648|NCT03106792|"     The primary outcome of the study is the effect of Hairfinity vs. Placebo on the rate of     distal hair growth, assessed using Trichoscan HD, in healthy female adults from baseline to     day 90 (end of study).   "
39958|NCT02762591|"     The purpose of this program is to provide patients with PDP access to pimavanserin until the     product receives marketing approval from the FDA and is commercially available.   "
13651|NCT03106753|"     The purpose of this study is to determine the best way to optimize the success of external     cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is     recommended because it may decrease the risk of needing a cesarean section for abnormal     presentation. While the study team knows that this procedure can be effective, the study team     still has some un-answered questions as to the best way to perform this procedure to increase     the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of     medication placed in your back to numb and relax the abdomen) can increase the success rate     of a version. This ultimately has led to the finding that using this anesthesia can decrease     the rate of cesarean section. However, there have been only a small number of studies     assessing the success rate if spinal anesthesia is used only in the event that without it     fails. Therefore the study team is going to compare patients who receive spinal anesthesia     with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails     without it.   "
13652|NCT03106740|"     In this research, the study team will use brain imaging to evaluate the presence of     neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy     of minocycline use for low back pain treatment will also be evaluated by observing whether     short-term minocycline administration will reduce neuroinflammation and low back pain     symptoms.   "
13664|NCT03106584|"     The purpose of the study is to test 30 individuals with mild-moderate knee joint     osteoarthritis to investigate whether the combination of Aquamin (a calcium-rich marine     multi-mineral) and a polyphenol-rich pine bark extract (Enzogenol), when taken as a food     supplement for 3 months has comparable or superior benefits to glucosamine sulphate in     patients with painful knee osteoarthritis (KOA). From here on in we refer to Aquamin's     combination product as Aquamin-plus. The main outcome measure is a reduction in pain.      Provision of data that demonstrate preliminary equivalency or superiority to current,     non-pharmaceutical options such as glucosamine will broaden consumer choice, and provide them     with an option that is supported by science, rather than marketing alone.      The hypothesis of the study is that the consumption of Aquamin-plus will have comparable     effects on reducing pain in individuals with Knee Joint OA to glucosamine.   "
13666|NCT03106558|"     This is an early user evaluation of the robotic-assisted total knee arthroplasty platform.     The objective of this surgeon group is to capture data on the defined objectives and provide     Stryker with feedback.   "
13653|NCT03106727|"     This protocol concerns the implementation and evaluation of an intervention designed to     realign the existing cadre of Community Health Workers (CHW) in Neno District, Malawi to     better support the care needs of the clients they serve. The proposed intervention is a     'Household Model' where CHWs will be assigned to households, rather than HIV or TB specific     patients, and will be trained to provide support for a wider range of conditions including     HIV, hypertension, diabetes, and pediatric malnutrition. The new model is designed to improve     retention in care for clients with chronic, non-communicable diseases, along with increased     uptake of women's health services and treatment for pediatric malnutrition, while sustaining     the high retention rates for clients in the HIV program. Eleven sites (health centres and     hospitals) were arranged into six clusters by estimated size of the catchment area     populations, with a population range of 11,680 to 26,260 and an average population of 20,400.     The order in which the intervention will be rolled out across the sites will be randomized so     that the intervention can be evaluated in a stepped-wedge cluster randomized controlled     trial. These clusters were grouped based mostly on geographic location but also on catchment     area sizes, in order to maximize feasibility of training for the CHW team and not overload     CHW training sessions with too many trainees.   "
13654|NCT03106714|"     The Zika infection is a viral disease that is transmitted to humans by the same mosquito that     transmits Dengue and Chikungunya fever. The Zika virus has been found in various body fluids     such as urine, blood and semen, but we do not know how long it persists in these fluids. For     example, parts of the virus were reported to persist in semen after six months of the onset     of symptoms, but we do not know if the virus can stay longer. In this way, we want to     investigate how long the Zika virus can be found in other secretions besides blood and urine.      Study Hypothesis: ZIKV can be shed in human body fluids long after the time of the acute     infection. Persistence of ZIKV in different body fluids may vary due to the influence of     circulating specific ZIKV IgM and IgG, as well as host and environmental factors.   "
13655|NCT03106701|"     This study represents an extension of a previous study (NCT02641431) on the acute and     long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF     inducibility in 200 consecutive BrS patients.   "
13656|NCT03106688|"     The goal of this project is to characterize the neural and psychological mechanisms that     contribute to development of obesity in the early adulthood. We address the neuromolecular     risk factors for obesity using multi-modal molecular (positron emission tomography with) and     functional (functional magnetic resonance imaging) neuroimaging in a prospective design.     Normal weight adolescents with high versus low familial, genetic and psychological risk     factors for obesity will be studied and followed for five years.   "
13657|NCT03106675|"     Bone metastasis give rise to major complications that lead to significant morbidity and     impairment of life quality. The most common primary for bone metastasis is prostate, lung and     breast carcinoma. These three have the highest cancer incidence in the USA with up to 85%     prevalence of bone metastases at the time of death. Pain from these osseous lesions can be     related to mechanical or chemical factors. Pressure effects on the periosteum or adjacent     neural structures can cause local or radiating pain. Hemorrhage from local bone osteolysis by     osteoclastic activity causes a local release of bradykinin, prostaglandins, histamine and     substance P that can irritate the endosteal nerves as well as local nerves.      The life expectancy of patients with osseous metastatic disease is variable but can be     substantially longer for patients with multiple myeloma, breast or prostate cancer.     Therefore, finding an effective local therapy that can improve patient quality of life and     can be done at a single outpatient sitting would be beneficial.      The current and emerging treatments for osseous metastases may be considered in several     categories: radiotherapy, systemic chemotherapy (cytotoxic, hormonal and radionuclides),     surgical stabilization and percutaneous tumor ablation. These treatments may be applied in     isolation but also frequently in combination.      MRI Guided High Intensity Focused Ultrasound (HIFU) is a completely non-invasive technology     for thermal ablation. HIFU is capable of concentrating ultrasonic pressure waves to a     specified region without any physical penetration of the body. The converging ultrasonic     pressure wave is converted to thermal energy at the specific depth, resulting in local     heating at the focus. Temperature elevation is proportional to the proton resonance frequency     shift, therefore MR imaging provides accurate technique for target definition and energy     deposition control. MRI guided Focused Ultrasound therapy is being performed in treatment of     uterine leiomyomas (fibroids). Recently the method has gained both AMAR authorization and FDA     approval, and CE approval for that indication.      Clinical trials of HIFU in bone metastases have indicated that the method is safe and gives     an effective reduction of patient pain. The short- and long-term effects on tumor volume and     morphology do not seem to have been evaluated thus far.      The primary objective of this trial is to evaluate effectiveness of MRI guided HIFU in the     treatment of metastatic bone tumors   "
13658|NCT03106662|"     Mesenchymal stem cells (MSCs) have been used in the treatment and prevention of graft-versus     host disease (GVHD). In this study the investigators aim to present the efficacy of     mesenchymal stem cells in graft versus host disease prophylaxis and effect of engraftment in     haploidentical recipients. Forty patients aged older than 18 who have indications for     haploidentical hematopoietic stem cell transplantation will be included to the study. MSCs     will be isolated from donor bone marrows and infused to the patient after conditioning     regimen on day +6. If the haploidentical transplantation results improve with MSCs treatment     it would be possible to ameliorate the problem of HLA-matched donor paucity in Turkey and     prefer haploidentical donors.   "
14634|NCT03093909|"     The goal of this clinical research study is to find the highest tolerable dose of gemcitabine     that can be given by inhalation (breathing it as a mist) to patients with solid tumors that     have spread to the lungs from other parts of the body.      The safety and side effects of this drug will also be studied.   "
13659|NCT03106649|"     The main aim of the study is to compare the proposed algorithm for preventing and treating     spinal hypotension with normal anesthesia management of a spinal anesthesia.      The proposed algorithm mainly will depend upon the left ventricular end diastolic area     measurement by transthoracic echocardiography to assess the left ventricular preload status     and its usefulness in preventing and treating spinal hypotension.   "
13660|NCT03106636|"     Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The     goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost,     manualized, group-based intervention for preschoolers and their caregivers. The investigators     will examine the extent to which the two intervention conditions show improved parenting,     reduced rates of disrupted placements, and improved child outcomes.   "
13661|NCT03106623|"     The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to     combination of solifenacin succinate and mirabegron or placebo for overactive bladder   "
13662|NCT03106610|"     The goal of this clinical research study is to learn about the tolerability of nivolumab in     participants who have bladder cancer, were previously treated with BCG immunotherapy, and who     have a cystectomy (removal of all or part of the bladder) scheduled as part of participant's     standard care.   "
13667|NCT03106545|"     Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even     result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture     of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative     analgesia and decreases opioid consumption as compared to bupivacaine alone or to general     anesthesia.   "
13668|NCT03106532|"     Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and     safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma   "
13669|NCT03106519|"     Treatment of Dupuytren's contracture requires multiple injections into the palm of the hand     to weaken the cords, followed by rupture of the strands 2 days later. Anesthesia is required     for both phases of treatment. It is hypothesized that extended-release liposome bupivacaine     prolongs nerve blockade of the wrist allowing patients to undergo this 2-part regimen with     less pain.   "
13670|NCT03106506|"     The objective of this randomized controlled clinical study was to evaluate the increase in     the volume of peri-implant gingival tissue in implants installed in the aesthetic areas with     the use of subepithelial-conjunctive tissue graft, and a sample of 40 individuals with     implants Aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will     receive only the dental implant without the placement of a tec graft.     Epithelial-conjunctival.   "
13671|NCT03106493|"     The goal of the Upstate KIDS Study is to track the growth, development and long-term health     of children given the increasing use of infertility treatment, occurrence of maternal obesity     and pregnancy complications, and rising maternal age at birth.   "
13672|NCT03106480|"     Emerging evidence from high-income countries suggests that diabetes mellitus is become a     major health problem among HIV-infected patients. However, due to differences in social,     environmental, and genetic factors data from high-income countries can not be extrapolated     directly to low-income countries. This study investigates HIV, ART, inflammation, and body     composition changes as risk factors for diabetes mellitus among HIV-infected patients in     Tanzania.   "
13673|NCT03106467|"     Despite growing popularity, practical advantages of single-port laparoscopic appendectomy     (SLA) over conventional three-port laparoscopic appendectomy (CLA) have yet to be established     well in pediatric population.      The investigators designed the randomized controlled trial to clarify practical advantages of     SLA over CLA in pediatric population. The investigators compared conversion rate,     intra-operative adverse events, operating time, wound complications, intra-abdominal     complications, and postoperative hospital stay, changes in postoperative pain severity, and     cosmetic outcomes during follow up period between SLA and CLA groups.   "
13686|NCT03106298|"     This study investigates the effects of intravenous (IV) iron sucrose therapy on blood levels     of Fibroblast Growth Factor 23 (FGF23, a protein that regulates the amount of phosphate in     the body) in iron deficiency anemia in healthy participants, participants with Congestive     Heart Failure (CHF, where the heart does not pump adequate blood supply to the body),     participants with Chronic Kidney Disease (CKD, where the kidney function is reduced), and     participants with CKD and CHF.   "
13674|NCT03106454|"     Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl     estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to     improve the risk profile associated with the COC. In 2010, the Food and Drug Administration     approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo     loestrin). However, no studies have compared this formulation to pills containing either     higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient     to prevent follicular development or to support the endometrium as well as higher doses of     EE. This trial addresses the question of whether an oral contraceptive pill with EE     10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect     profile than a progestin only pill with a nearly equal dose of norethindrone.   "
13675|NCT03106441|"     Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a     critical event. The aim of this study is to determine whether Nasal High Flow Therapy by     nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal     intubation after crash induction in obese patients   "
13676|NCT03106428|"     To assess safety and tolerability, describe the dose-limiting toxicities, determine the     maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose)     in the absence of establishing the MTD, and a recommended dose for further evaluation of     MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are     refractory to prior standard therapy, and for whom there is no standard salvage regimen     available.   "
13677|NCT03106415|"     This phase I/II trial studies the best dose of pembrolizumab and binimetinib and how well it     works when giving together with pembrolizumab in treating patients with triple negative     breast cancer that has spread to other parts of the body. Monoclonal antibodies, such as     pembrolizumab, may block tumor growth in different ways by targeting certain cells.     Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Giving pembrolizumab and binimetinib may work better in treating patients with     triple negative breast cancer.   "
13678|NCT03106402|"     To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs)     after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the     prevention of pseudophakic cystic macular lesions   "
13679|NCT03106389|"     This randomized controlled study will be performed to compare the benefits and risks     associated with the administration of misoprostol with or without the use of a transcervical     balloon catheter to terminate pregnancy in the second trimester (defined as gestational age     between 14 and 28 weeks of gestation).   "
13705|NCT03106051|"     A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to     100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's     medical section. To increase the quality of the data and to reduce distribution of the data     collected, centers to be included will be those which can enroll at least 5 patients. Care     will be taken to ensure a balanced regional distribution. The proposed observation period for     the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks.     Proposed duration from first patient in (FPI) to last patient out (LPO) is thus 24 months.   "
13870|NCT03103893|"     This trial examines the impact of a topical formulation of rapamycin on dermal thickness and     senescence.   "
13681|NCT03106363|"     Alcohol and cannabis are the two most widely used substances of abuse in the world and are     the psychoactive substances most often found in seriously and fatally injured drivers. In a     recent study, it was observed that individuals who reported both driving under the influence     of alcohol (DUIA) and the influence of cannabis (DUIC) experienced collision risk that was     nearly 4 times that of individuals who reported driving after using only one of these drugs.     Recent research in the United States and Canada indicates that the prevalence of DUIC among     young drivers of high school and university age, and young adults is similar to, or higher     than, the prevalence of DUIA. This is a serious public health issue, since motor vehicle     collisions are the leading cause of death in this age group. Given the frequency with which     alcohol and cannabis are consumed together, it is important to understand their combined     effects on driver behaviour. The residual or 'hangover' effects of these substances on road     safety are also not well understood, but may be substantial. To date, the residual effects of     combined use have not been examined. The current study will examine the acute and residual     effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of     alcohol (BAC=0.08) on driving simulator performance of young drivers. Following an     eligibility screening and practice session, a total of 70 participants aged 19 to 25 years     will each complete 8 experimental sessions (2 sessions/week). During the first session of     each week, subjects will drink alcohol or placebo alcohol and smoke an active or placebo     cannabis cigarette. The effects of alcohol and cannabis on the performance of driving-related     skills will be assessed using a high-fidelity driving simulator. Cognitive, psychomotor, and     mood effects will also be assessed. Twenty-four hours after alcohol/drug exposure, subjects     will attend the second session of the week where driving-related, cognitive, psychomotor, and     mood effects will be assessed again.   "
13682|NCT03106350|"     EORTC-QLQ-30 questionnaire filled in by participants 6 times   "
13683|NCT03106337|"     As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing     surgery will have benign lesions verified by histopathology after surgery.      Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a     result these subjects will have had surgery for diagnosis of a benign lesion.      The aim of this study is to see whether shear-wave elastography, a new ultrasound technology     can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients     will not need surgery for the diagnosis of a benign lesion.      The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound     technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular     lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and     are scheduled for thyroid surgery will be eligible to participate. All participants will     undergo a detailed ultrasound examination prior to their surgery. The results of the     ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy     of SWE.   "
13684|NCT03106324|"     This post authorization safety study is designed as prospective non interventional study for     patients with newly diagnosed multiple myeloma who are not eligible for transplant. The     objective is to compare the incidence of cardiovascular events between patients treated with     a first-line lenalidomide containing regimen and those treated with a first-line     non-lenalidomide containing regimen. Treatment in both cohorts will be done according to     standard care. The study will gather risk factor information at baseline and throughout     follow-up. Any cardiovascular event occurring will be assessed by an independent committee.     Other safety endpoints will be collected through standard procedures. Observation period will     be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months'     post treatment and a follow up period until 5 years after inclusion. During follow up the     incidence of second primary malignancies (SPM) and overall survival will be assessed.   "
13685|NCT03106311|"     Two groups will be recruited. The first group are pregnant ladies that have unequivocal     rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the     vagina. The second group are normal pregnant ladies without rupture of membranes. both groups     will be tested by taking vaginal washing fluid. Quantitative and qualitative pregnancy tests     will be measured in this fluid.   "
13691|NCT03106233|"     The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for     autologous breast reconstruction when the abdomen is not suitable as a donor site. In this     prospective study all LTP flap breast reconstructions that have been performed since     September 2012 are analyzed. In addition, the surgical refinements that were introduced over     the years are reported.   "
13692|NCT03106220|"     Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in     patients with end-stage liver disease. The presence of these complications portends poor     prognosis. The purpose of this study is to assess the impact of a formal home based video     strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of     this exercise program on complication rates, hospitalization, on quality of life (QOL) and on     survival.   "
13693|NCT03106207|"     Despite the high success rates of gastric bypass in the short and long terms, little is known     about possible anatomopathological changes that can occur in these patients. The objective is     to investigate preoperative and postoperative endoscopic changes in patients undergoing     gastric bypass without a ring. Thirty obese patients from different regions of the country     with the surgical indication for the Roux-en-Y gastric bypass will be studied prospectively.     All patients will be submitted to upper gastric endoscopy (UGE) two, six and 12 months after     the surgical procedure at the Kaiser Clinic. This study will identify whether there are     endoscopic changes within one year after the surgery and what they are. Changes, if they     exist, will be correlated with clinical data, in order to make an accurate prognosis of the     patient, thereby contributing to the outcomes of future patients submitted to this type of     procedure.   "
13694|NCT03106194|"     To study the impact of case management on the outcome of the care of chronic hepatitis C in     people who inject drugs (PWID). By creating the function of case manager, the investigators     will target all the barriers to care of the HCV care continuum. Partial objectives are to     measure the impact of case management on the uptake for screening, the uptake and outcome of     treatment, and the rate of reinfection.   "
13706|NCT03106038|"     The purpose of this clinical trial is to study the safety and efficacy of an investigational     imaging agent for delineation/visualization of urologic anatomy in the setting of minimally     invasive surgery.   "
13707|NCT03106025|"     The study is collecting data along with other academic institutions regarding the accuracy of     ocular ultrasound in diagnosing retinal detachment.   "
13742|NCT03105570|"     To balance the oncological safety and cosmetic outcome is the basic principle of modern     breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage     but concerns regarding local recurrence make the oncological safety of nipple sparing     mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer     is rare compared to that of nipple, we designed the current study to investigate the     oncological safety and cosmetic outcome of Areola Sparing Mastectomy.   "
13695|NCT03106181|"     Glaucoma is the commonest cause of irreversible blindness in the world. Treatment centres     around lowering intraocular pressure (IOP) and typically includes medication (least     invasive), laser, to surgery (most invasive). The gold-standard glaucoma operation is the     trabeculectomy. Whilst it is effective at lowering IOP, it is associated with potentially     devastating complications including bleb leak, hypotonous maculopathy, blebitis and     endophthalmitis. In recent years, minimally- invasive glaucoma surgery (MIGS) has become an     increasingly popular option of treating mild to moderate glaucoma. It is usually performed in     conjunction with cataract surgery. The iStent (Glaukos Corporation, California, USA) is one     of the most commonly utilised MIGS devices in the world and one of two Therapeutic Goods     Administration (TGA)- approved MIGS devices in Australia. The iStent Inject® is the second     generation iStent device and Australia is one of the first countries in the world to have     access to this. So far there are no published randomised controlled trials comparing the     effect of cataract surgery alone to combined cataract surgery with insertion of iStent     Inject®.      This study aims to recruit patients of the Glaucoma Investigative and Research Unit (GIRU) of     Royal Victorian Eye and Ear Hospital (RVEEH) with mild to moderate glaucoma who are due to     undergo cataract surgery and randomise each to either cataract surgery or combined cataract     surgery with iStent Inject® insertion. Only patients who meet the inclusion criteria and none     of the exclusion criteria will be recruited. The outcomes measures of the study will be a     comparison of: 1) extent of IOP reduction; 2) reduction in number of topical glaucoma     medications; 3) patient treatment satisfaction - between the two treatment groups.   "
13696|NCT03106168|"     To evaluate subjectively and objectively the quality and efficacy of local anesthetic block     with mepivacaine in simple extraction of mandibular molar. Provide and collect information     such as: signs and symptoms, quality of anesthetic block, quantify pain and / or discomfort,     as well as medication used, both preoperatively and postoperatively.   "
13697|NCT03106155|"     [Study Design] This study is a single arm, multi-center phase II study of vistusertib     monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR     amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12     hours) until they demonstrate objective disease progression or they meet any other     discontinuation criteria.      [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with     relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy   "
13698|NCT03106142|"     The aim of this study is to improve the referral rates to physiotherapy of patients with knee     osteoarthritis. The intervention consists of one academic detailing visit directed to general     practitioners (GPs)   "
13699|NCT03106129|"     Total knee arthroplasty (TKA) may result in significant postoperative pain. The majority of     these patients are prescribed opioids for the management of postoperative pain. Recent     evidence has highlighted that postoperative opioids are being over-prescribed resulting in     opioid misuse and abuse. Over-prescribing also results in a significant financial cost. This     prospective observational study was designed to determine the mean amount of opioid required     after TKA. This data can be used in the future as a guide to change our current practice of     prescribing with the aim to reduce over-prescription.   "
13700|NCT03106116|"     The purpose of this study is to investigate the efficacy of Enhanced External     Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart     disease   "
13701|NCT03106103|"     Urodynamic Study (UDS) represents a series of agreed-upon clinical tests and is used to     evaluate the functional status of the lower urinary tract, providing a pathophysiological     basis for urinary symptoms. Urodynamic Study involves catheterization of the lower urinary     tract. The prevalence of urinary tract infection after UDS ranges from 1,5% to 30 %.      Studies of prophylactic antibiotics for UDSs have offered data of contradictory and limited     predictive values. Some investigators concluded that prophylactic antibiotics were valuable     and others have not.      The objective of this study is to evaluate the efficacy of antibiotic prophylaxis before UDS     in women, using different antibiotic regimens.   "
13884|NCT03103711|"     The aim of this study is to analyze the effect of a brief psychological intervention     supported by Information and Communication Technologies, on the subjective well-being of     hospitalized cancer patients. Participants are randomly assigned to one of 2 conditions:     Intervention condition (4 Virtual reality sessions) and Control condition (waiting list     control group).   "
13702|NCT03106090|"     The study will focus on survivorship care for head and neck cancer patients cared for within     Duke Cancer Center clinics. Standardized survivorship care plans (sSCP) are being implemented     based on the American Society for Clinical Oncology's criteria. These documents provide a     summary of treatment received, and list side effects and follow-up information after cancer     treatment. Taking advantage of this transition, the investigator will study three groups of     patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors     treated after the sSCP was implemented, and (c) current patients who will receive an     individualized enhanced SCP (eSCP), which will include additional information tailored to     patient preferences. The investigators hypothesize that patients receiving enhanced     survivorship care plans will increase their knowledge regarding their health care plan and     wellness trajectory; increase their ability to identify the symptoms they most likely can     expect as a result of their cancer treatment; and be more likely to engage in conversations     with their PCP about healthy behaviors and screening guidelines.   "
13703|NCT03106077|"     The goal of this clinical research study is to learn if mirvetuximab soravtansine can help to     control either newly diagnosed or metastatic (has spread) triple-negative breast cancer     (TNBC).      Mirvetuximab soravtansine is designed to stop cell growth by blocking certain proteins in the     cancer cells related to the mineral folate. This is believed to cause the cancer cells to     die.   "
13704|NCT03106064|"     This study is a randomized clinical trial conducted in a medical ward of an acute 580-bedded     teaching hospital. One hundred fifty-eight older acute medical patients will be blindly     randomly allocated to the control group or intervention group. The intervention will consist     of a twice daily walking training, plus privileging trips to the toilet by walking and all     daytime meals seated. Differences between groups will be measured at baseline (admission) and     discharge. As primary outcomes, we defined the length of stay and the independence level. The     independence level will be assessed at baseline (admission) and discharge by two distinct     methods: through the Barthel Index and the Patient Classification Systems(PCS).   "
13708|NCT03106012|"     The hysteroscopy used was rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl     Storz, Germany). It has a 30o panoramic optic which is 4mm in diameter and the diagnostic     continuous flow outer sheath is 6.5 mm in diameter.      The patient was placed in lithotomy position with the buttocks projecting slightly beyond the     table edge. A reflex camera (Olympus) with an objective that has a focal length varies from     f70 to f140 together with (Karl Storz) special zoom length, adapter to Hopkins telescope and     a suitable cableware used with computer flash unit. The hysteroscopic picture which appeared     through the optic, transmitted on the monitor by the camera which is fitted on the eyepiece     of the optic where the panoramic diagnostic hysteroscopy could be informed with better     visualization and accuracy. The light generator which is a metal halide automatic light     source with a 150 watt lamp (model G71A,Circon ACMI, Germany) was switched on and the high     cable was attached to the hysteroscope. Dilatation of the cervix was avoided whenever     possible to avoid leakage of the medium into the vagina. The hysteroscope was then introduced     into the external os and advanced under vision along the axis of cervical canal.      Once the cavity was entered, an overview of the uterine cavity was performed. This was     followed by systematic examination for fundus then tubal ostia on both sides then the uterine     wall through slow rotatory movements of the telescope.      Diagnostic laparoscopy was done in the proliferative phase of the menstrual cycle .The     patients were placed in the dorsal lithotomy position to allow vaginal access for uterine     manipulation; the legs positioned so that the thighs are slightly flexed no more than 90o     from the plane of the abdomen.      The patient was placed in the complete horizontal position, Veress needle was placed through     the umbilicus and into the peritoneal cavity, the primary trocar with sleeve (5mm in     diameter) was placed at a similar angle in to the Veress needle.      Secondary trocars were used, 2 secondary trocars were placed. The trocars were placed     laterally, approximately 8 cm from the midline and 8 cm above the pubic symphysis to avoid     the epigastric, vessels which are 5.5 cm from the midline at this level.      Then laparoscopic dye chromotubation was performed   "
13709|NCT03105999|"     In COPD patients, a distinctive clustering of symptoms in the 3 parts of the day, early     morning, day-time and night-time has been observed. These clusters are relevant to shape the     health status and to explain the need of care. The objective of the STORICO study is to     quantify the intra-day fluctuation of symptoms and to verify whether it: marks selected COPD     phenotypes and is stable over time. STORICO is an observational prospective cohort     multicenter study. 600 COPD patients >50 years will be enrolled. The multidimensional     assessment will cover pattern of symptoms, complete spirometry and DLCO (Diffusing capacity     of Lung for Carbon Monoxide ), comorbidity and health status. Based on clinical data,     patients will be grouped in clinical phenotypes. Intra-day symptoms fluctuation will by rated     by standardized questionnaires and the relationship between clinical/statistical clusters and     symptoms fluctuations assessed. Finally, patients will be reassessed at 6 and 12 months, and     the 12 month incidence of selected outcomes (frequency of exacerbations, use of health care     resources) will be computed. Results are expected to clarify the classificatory and     prognostic role of symptoms fluctuations in addition to classical measures of disease status     and to compare health status and prognosis of clusters. Intra-day variations and stability of     symptoms over time will likely improve our understanding of phenotypic variability of COPD.   "
13710|NCT03105986|"     The purpose of this study is to evaluate the effect of multiple-dose administration of     probenecid on the pharmacokinetics of JNJ-63549109 and JNJ-64167896 after a single dose of     JNJ-64041575 in healthy adult participants.   "
13711|NCT03105973|"     In the United States, over 60% of the 2.2 million people who are incarcerated struggle with     mental health problems. Currently, correctional facilities are limited in their ability to     provide care. As technology-enabled interventions for mood disorders have demonstrated     efficacy outside of correctional facilities, the investigators propose to build and test a     technology-enabled mood disorder treatment intervention for individuals who are incarcerated.   "
39959|NCT02762578|"     This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of     insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.   "
13713|NCT03105947|"     This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from     the general community are randomized into one of three arms: participants will be provided     with 50 gm extra virgin coconut oil,or 50 grams butter or 50 extra virgin olive oil to be     eaten daily for a month. The key outcome is blood low density lipoprotein cholesterol     concentrations and secondary outcomes blood lipid profile (total cholesterol, high density     lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist     circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol     difference between the trial arms.   "
13714|NCT03105934|"     To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and     standard PAH clinical measures of disease progression and the relative sensitivity of the     techniques to change.   "
13715|NCT03105921|"     The aim of the study is to evaluate the use of irreversible electroporation in the treatment     of locally advanced cancers of the head of pancreas with vascular spread. This technique     would allow to treat the unresectable part of the tumor to make it more accessible for a     secondary surgery.   "
13716|NCT03105908|"     The overall aim of the present study is to evaluate an internet-delivered Acceptance and     Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the     study will evaluate if 1) iACT is effective in improving functioning and quality of life in     comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence     treatment outcome (i.e. predictors, moderators or characteristics of treatment responders),     4) if psychological variables mediates the effects of treatment on outcome, and 5) if     subgroups of patients varies in change processes (i.e. moderated mediation).      The main hypothesis is that iACT will improve functioning and quality of life.   "
13717|NCT03105895|"     It has been demonstrated that incisional hernia incidence after laparotomy can be safely     reduced with the addition of a mesh to the conventional closure of the abdominal wall. There     still some debate about which is the best position to place this mesh: onlay or sublay. In     Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall     closure. The investigators have planned to include 200 patients in a multi center study using     an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be     patients with risk factors for the development of an incisional hernia. The incidence of     incisional hernia will be assessed clinically and radiologically after 1 and 2 years     follow-up. The incidence of surgical sites occurrences and pain will be also assessed.   "
13718|NCT03105882|"     Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the     Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological     Levels The purpose of this study is to support an expansion to support marketing applications     as well as future studies.   "
13719|NCT03105869|"     Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in     prostate cancer   "
13720|NCT03105856|"     Objective. To evaluate the impact of HPV vaccination as part of a hrHPV-based primary     screening program to extend screening intervals.      Materials and methods. A total of 18,000 women aged 25-45 years, attending the regular     cervical cancer-screening program in primary health care services in Tlalpan, Mexico City,     will be invited to the study. Eligible participants will be assigned to one of three     comparison groups: 1) HPV16/18 vaccine and hrHPV-based screening; 2) HPV6/11/16/18 vaccine     and hrHPV-based screening; 3) Control group who will receive only hrHPV-based screening.     Strict surveillance of hrHPV persistent infection and occurrence of precancerous lesions will     be conducted to estimate safety profiles at different screening intervals; participants will     undergo diagnosis confirmation and treatment as necessary.      Discussion: The FASTER-Tlalpan Study will provide insights into new approaches of cervical     cancer prevention programs. It will offer valuable information on potential benefits of     combining HPV vaccination and hrHPV-based screening to safety extend screening intervals.   "
13721|NCT03105843|"     The objectives of this study are to determine the sensory-mechanical responses to Eucapneic     Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) in individuals with cough variant     asthma (CVA) and methacholine-induced cough with normal airway sensitivity (COUGH) and     compare these responses to a control group of healthy individuals without asthma or chronic     cough.      We hypothesize:        1. EVH and HS cause dyspnea, cough, small airway obstruction with resultant dynamic          hyperinflation, gas trapping and autoPEEP in individuals with CVA and COUGH, but not          healthy controls.        2. The sensory-mechanical responses to both hyperosmolar challenges (EVH and HS) are          comparable within groups (CVA, COUGH and healthy controls).   "
13722|NCT03105830|"     Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor.      Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug     in blood   "
13723|NCT03105817|"     In post-dilution haemodiafiltration only synthetic membranes have been used to date.      The allergy problems described with these membranes require the development of other     membranes capable of performing this treatment. We describe in vivo performance and behaviour     of an asymmetric cellulose triacetate(ATA™) membrane, to identify its depurative     effectiveness and ease of use in clinical practice, as well as evaluate its biocompatibility     in a single haemodialysis session (acute biocompatibility) and after one month of treatment     (chronic).   "
13724|NCT03105804|"     To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four     different marketed electronic cigarettes. Furthermore, to measure overall product liking by     subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in     the future.   "
13725|NCT03105791|"     Prospective, randomized clinical trial investigating the use of patient education on     post-operative narcotic consumption   "
13726|NCT03105778|"     Part 1 (POC Precision):      Objective :      Demonstrate that the Minicare BNP (im)precision in hands of the user is within the expected     range of the Minicare BNP (im)precision. Part 2 (sample comparison)      Primary objective :      Compare Minicare BNP values from capillary whole blood from finger stick with EDTA whole     blood from venous puncture.      Secondary objective :      Compare Minicare BNP values from EDTA whole blood and plasma with Li- Heparin whole blood and     plasma from venous puncture.   "
24923|NCT02959450|"     The purpose of this trial is to design, implement and evaluate the effect of a nutritional     intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of     energy and protein.   "
13727|NCT03105765|"     Chronic Pain, especially neuropathic pain, are adverse events after posterolateral     thoracotomy for lung resection. The continuous application of ketamine may have a     prophylactic effect and helps to prevent chronic pain. The investigators record the incidence     and severity of acute pain and neuropathic pain during a seven day period after thoracotomy     as well as the incidence of chronic pain and neuropathic pain after one and three month     period. Parallel Group design, comparing one Group with a continuous application (24 hours)     of ketamine against a Placebo Group.   "
13728|NCT03105752|"     Prior to the completion of biomedical research, any person undergoing it must receive a     readable and intelligible information about this research, in order to give free and informed     consent. The willingness to inform patients of all risks and constraints related to research     may be in contradiction with the need to write informative and concise documents that are     understandable to research participants. As a result, consent forms are long, contain a lot     of information and are complicated to understand.      The objective of this study is to evaluate the impact of the readability of the information     and consent forms on the understanding of the information received by participants in     clinical trials.   "
13729|NCT03105739|"     The purpose of this prospective, randomized study was to compare the incidence of adverse     events associated with removal of the LMA either in deeply anesthetised or awake patients.   "
13730|NCT03105726|"     End-stage heart failure (ESHF) represents a major burden in terms of quality of life,     mortality and costs. The current practice in France is to treat patients with ESHF by a     combination of drugs and lifestyle interventions before proposing heart transplant (HT) if     there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in     Germany, patients presenting with ESHF are preferentially managed by ventricular assist     device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these     two strategies in the management of ESHF and associated consumption of resources.   "
13731|NCT03105713|"     This study develop safety checklists for patients to use before, under and after in-hospital     surgery. Patients and Healthcare personnel experiences and risk assesment are used to develop     the checklists. The checklist intervention will be sequentially rolled out in a randomized     order.   "
13732|NCT03105700|"     The purpose of this study is to determine if low-frequency transcranial magnetic stimulation     (TMS) is safe and feasible for treating depressive symptoms in patients with temporal lobe     epilepsy. Patients will receive an accelerated protocol of TMS consisting of three     consecutive days of treatment. Patients will have two in-person follow up visits after one     month and again after six months.   "
13733|NCT03105687|"     By conducting the SPPA trial we try to find out, whether personalized Short Message Service     (SMS) reminders of blood pressure-lowering medication can effectively increase patients'     adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect     on patients' systolic blood pressure control.   "
13734|NCT03105674|"     The primary aim is to test the magnitude and duration of analgesia provided by single dose     multi-drug analgesia administered for perianal block, and compare with standard solution     (Marcaine & Lidocaine in 1:1 mixture - Total 60 ml), at post-operative period and also to     compare with the standard solution including their respective post-operative opioid or     non-opioid oral analgesic requirement. Local anesthesia via a perianal block using multi-drug     analgesia or standard solution will be compared using the Numeric pain rating scale on     Post-operative day 1, 3 and during follow up visit on day 7. The investigators hope to find a     better control of post-operative analgesia which will lead to better functional outcomes.     Possible decrease consumption of opioids in the post-operative period will perhaps decrease     the cost and chances of addiction and will increase patient comfort and compliance.   "
13735|NCT03105661|"     To determine if the use of impedance cardiography can identify appropriate medications for     use in treating morbidly obese patients to decrease the risk of preeclampsia.   "
13736|NCT03105648|"     The prevalence of thyroid nodule is worldwide high. About 40% of normal population has     thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from     benign nodules because the management is completely different. Nowadays, the gold standard is     fine needle aspiration cytology (FNAC) examination. The overall sensitivity and specificity     is fair (~90%), but still has its limitation that some results are indeterminate in about 15%     of the nodules. These obstacles are especially troublesome for papillary and follicular     thyroid cancer that leads to delayed diagnosis, incomplete resection, and repeated operation.     Preoperative evaluation of the prognosis is extraordinary important for cancer management.     However, current prognostic scoring systems is only applicable after surgery. Hence, we     urgently need a better risk-stratification system for individual-tailored treatment, and     genetic-based computerized morphometry study seems to be the most realistic and promising     one. The goal of this study is to propose a reliable method for diagnosis and prognosis of     papillary thyroid cancer and follicular thyroid cancer through analyzing cellular morphologic     characteristics.   "
13737|NCT03105635|"     Some people living with health problems require extra support to properly manage their     conditions, as family doctors are only able to spend limited time in the office with these     patients. There are many resources and programs in the community that can provide the     necessary time and support for these patients, yet many patients are unaware that such     resources exist. Patient navigators have been shown to be useful in helping patients with     certain conditions (such as cancer) to get to the resources they need, especially when they     have social challenges that make it difficult for them to reach these programs (for example,     language or transportation barriers, poverty, or poor social support). This study will look     at how helpful Navigators are to link patients at family doctors' offices to community     resources. To do this, family doctors' offices in Ottawa will be recruited. All offices will     receive training on referring patients to community resources, and half of these     (intervention) will have a Navigator assigned to the practice. This study will assess whether     access to a Navigator increases patients' access to community social and health services. In     addition, the study aims to understand whether English and French speaking individuals are as     likely to benefit from a Navigator in accessing community health and social services in the     language of their choice.   "
15821|NCT03078400|"     Up to 18 women with ovarian cancer will administer up to two injections of SPL-108 daily in     combination with weekly doses of Paclitaxel. They will be monitored for safety and efficacy     for up to 6 months, until disease progression or unacceptable toxicity.   "
13738|NCT03105622|"     OBJECTIVE AND HYPOTHESIS:      The objective of this study will be to examine the effects of watching a screen or listening     to music while exercising on acute energy intake and expenditure. It is hypothesized that the     post-exercise energy compensation will be greater in both conditions with stimuli (i.e.,     screen and music) compared with the control condition (i.e., exercise alone).      STUDY DESIGN:      Randomized, 3-condition crossover study (within-subjects experimental design).      PARTICIPANTS:      The present study will recruit 25 male adolescents between the ages of 13 and 17 years.     Participants will be recruited via advertisements and word of mouth (first come first served     approach).      OVERVIEW OF THE STUDY PROTOCOL:      Preliminary Visit The participants will attend one baseline session and three experimental     sessions. The preliminary visit will include measurements related to anthropometry (body     weight, height, waist circumference) and resting metabolic rate. Participants will also     complete questionnaires in order to better characterize them.      Experimental Sessions Each participant will be engaged in each of the following three 30-min     experimental conditions followed by an ad libitum lunch: (1) walking/jogging on a treadmill     at 60% of VO2 peak while watching a screen (exercise + screen); (2) walking/jogging on a     treadmill at 60% of VO2 peak while listening to music (exercise + music); and (3)     walking/jogging on a treadmill at 60% of VO2 peak with no other stimulus (control condition).      MEASUREMENTS:      The main measures for this study include: anthropometric measurements, food intake, appetite     sensations, energy expenditure, resting metabolic rate, and ratings of perceived exertion.      OUTCOME MEASURES:      The primary outcome measure will be post-exercise energy compensation. The food intake     outcome will be assessed by using an ad libitum test meal immediately after the conditions     and a dietary record for the remainder of the day. The energy expenditure outcome will be     assessed by using an Actical accelerometer until bedtime. The secondary outcome measures will     include appetite sensations and the ratings of perceived exertion (OMNI scale).   "
13739|NCT03105609|"     Clinical trial investigating the role of hyperspectral imaging in the management of patients     undergoing standard clinical treatment for naive neovascular choroidal membranes in     age-related macular degeneration.   "
13740|NCT03105596|"     This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide     combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with     relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).   "
13741|NCT03105583|"     This cross-sectional study will try to give answers to the following project aims:        -  To provide an overview of the prevalence of health products' use among Belgian pregnant          women (prescription and OTC medication, vitamin supplements, phyto-therapeutics,          dermatologic products), including where pregnant women buy or get their health products          (online web survey).        -  To document women's beliefs about medication during pregnancy and their information          desire (online web survey).        -  To determine the current vitamin status among pregnant women and to reveal clinical          targets for supplementing deficiencies in this population (blood sample analysis).      The study will be performed at the obstetrics department of the University Hospitals of     Leuven (campus Gasthuisberg).      We aim to include 300 pregnant women (100 per trimester), of which 150 women will be asked to     determine their vitamin status (50 per trimester).   "
13753|NCT03105427|"     The potential use of regulatory T cells as preoperative risk stratification tool is evaluated     in order to improve clinical risk stratification and reduce perioperative morbidity and     mortality.   "
18540|NCT03042884|"     The goal of this research study is to learn how useful a wearable exercise tracker watch is     to monitor participant's physical activity and learn if it can help to increase participant's     physical activity.   "
13743|NCT03105557|"     On a daily basis many (prematurely born) newborn are subjected to different urine collecting     techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are     looking for a better and less invasive manner to collect urine in these vulnerable patients.     We hypothesise that the urine collecting device as presented in this protocol is less     invasive and has good functional abilities to collect urine in these newborns      Objective of the study:      Clinical feasibility of the urine collection device, indicated by staff and parents.      Study design:      The study will be an open label, clinical feasibility study, of the urine collection device.     During a period of 6 months, 30 feasibility tests will be performed.      Study population:      Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics     at Rijnstate Hospital Arnhem.   "
13744|NCT03105544|"     Detection of growth restricted fetuses relies primarily on abdominal ultrasound examinations     during pregnancy. Many clinicians, however, have not received systematic training and may     therefore perform inadequately. We wish to examine, whether systematic, simulation-based     training can improve diagnostic accuracy of estimated fetal weight by ultrasound at different     levels of clinical experience.   "
13745|NCT03105531|"     Primary aldosteronism (PA) is an under-diagnosed cause of arterial hypertension.     Cardiovascular morbidity and mortality in hypertension rises significantly for patients who     have aldosterone overproduction when compared with those with primary hypertension and the     same level of blod pressure elevation. The classical signs of PA such as severe hypertension     and hypokalemia may be absent, why screening in defined risk groups has been recommended.     Screening has not been systematically implemented in Sweden, probably due to expensive, time     and effort-consuming clinical routine protocols and low awareness of the problem among     clinicians. The prevalence of PA in patients with hypertension in Sweden has not been studied     adequately, and few studies from Northern Europe have addressed the problem.      The primary objective is to investigate prevalence of PA among patients with hypertension in     primary care and to implement and assess optimal treatment. Discovered cases of PA will go     through routine clinical work-up in order to distinguish the subtype of PA, which includes     computed tomography of adrenals and adrenal vein sampling (AVS) in those willing and fit for     surgical treatment. Treatment will be then chosen depending on the PA subtype. Those with     unilateral disease who are willing and fit for surgery will be offered unilateral minimally     invasive adrenalectomy. Patients who oppose or have contraindications to operative treatment,     as well as patients with bilateral disease will be offered medical treatment with     mineralocorticoid receptor antagonists (MRA).      Study participants will be then followed up one year after surgery or initiation of specific     medical treatment. Please se outcome measures for relevant description of those.      Blood samples will be collected from patients with confirmed PA to be stored in a biobank for     potential future genetical and biochemical studies. A subgroup of patients with PA will     undergo adrenal-specific positron-emission tomography to assess the possibility to     un-invasively diagnose and subtype PA.   "
13746|NCT03105518|"     The central objective of this study will be to evaluate the relationship between estrogen     levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.   "
13747|NCT03105505|"     The study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of     Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .   "
13756|NCT03105388|"     Incidence of difficult laryngoscopy and difficult intubation are higher among patients with     obstructive sleep apnoea (OSA). Precision in making the diagnosis and predicting difficult     laryngoscopy preoperatively may help to reduce anesthetic complications. This study was     designed to evaluate the diagnostic performance of combined and non-combined radiological     parameter (mandibulohyoid distance) and STOP-BANG questionnaire as screening tool.      Methodology:      Forty-one subjects who were at risk of OSA, undergoing general anaesthesia will be included     using STOP-BANG questionnaire. Mandibulohyoid distance and other radiological parameters will     be measured from lateral cephalometry. Evaluation for difficult laryngoscopy will be carried     out during anaesthesia.   "
13749|NCT03105479|"     Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal     studies. The results of a first study conducted in adult patients have suggested efficacy of     the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is     the first study of cadazolid in children. The overall purpose of this study is to provide     reassurance on the safety and efficacy of cadazolid in children suffering from infection due     to Clostridium difficile.   "
13750|NCT03105466|"     The performance of keratoplasty is hampered by the limited availability of donor cornea in     many countries, especially in Asia. For this reason, attempts have been made to fabricate     artificial substitutes for natural human cornea. So far, all polymeric biomaterials, such as     collagen configurations and plastic compression, could mimic the functional optically     transparent but failed to replicate the complicate three-dimension microstructure of natural     cornea. Therefore, despite some favorable results yielded by polymeric biomaterials, they     cannot be suited for long-term use. To overcome these disadvantages, in recent years, porcine     cornea appeared specifically attractive for xenotransplantation, because of its accessibility     and similarities to natural human cornea. However, xenotransplantation using fresh porcine     cornea can occurs hyperacute immune rejection, resulting in graft failure. Such transplant     rejection can be substantially lessened by using acellular porcine cornea (APC), which     preserves the constructure of natural cornea, whilst having well biocompatibility and low     antigenicity. These properties feature APC particularly suitable for high-risk keratoplasty,     such as corneal grafting in infectious keratitis.      Use of APC in LK has been shown promise in many preclinical animal studies and initially in     human clinic trail. However, to optimize APC biological and biomechanical properties, the     strategies for its preparation has evolved extensively over recent years, like various     decellularization approaches (e.g. detergents, enzymes, human sera, hypertonic solutions and     et al) and additional procedures (e.g. collagen re-crosslinking and repeated frozen-dry).     Therefore, in the current study, the investigators analyzed the early surgical outcomes of     deep anterior lamellar keratoplasty (DALK) using the APC that was very recently approved by     the National Institutes for Food and Drug Control (NIFDC) of China for clinic practice, for     management of infective keratitis, including fungal, viral and acanthamoeba keratitis. Here     major concern of this study was to clarify the behavior of APC after implantation in     participants.   "
13751|NCT03105453|"     To assess the impact of the female genital microbiome on ART outcome.   "
13752|NCT03105440|"     The aim of this study is to evaluate the effects and validate news physiotherapy techniques:     robotic rehabilitation, virtual reality, vibration therapy, canoeing and hand cycling in the     secondary clinical complications of the breast cancer, through the Biomedical     Instrumentation. It will be realized the double-blind longitudinal clinical study. Will     participate in the study 100 women post breast cancer surgery, the volunteers will be     allocated in the respective modalities treatment; and 20 healthy volunteers, will be only the     control group. The volunteers conducted 10 physiotherapy session, and it will be evaluated     after, during and before of the treatment, to evaluated myoelectric activity, scapular and     hand muscle strength, range of motion, circumference of the upper limbs and quality of life.     Expected to Positive Results With regard to the minimization of pain intensity and     lymphedema, favoring the improvement of range of motion of the shoulder joint, myoelectric     activity, increased muscle strength, and consequently improves the quality of life.   "
13754|NCT03105414|"     Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults,     however, few data exist regarding VAP in the paediatric intensive care population. The     Centers for Disease Control (CDC) definition for VAP is regularly updated trying to     homogenised practice, and the last version for paediatrics has been published in 2015.     According to the latest CDC definition, the investigators aim to study incidence of VAP in     different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP,     microbiology of VAP, and utilisation of empirical antimicrobial therapy.      Methods and population : a prospective multicentre observational study will be conducted in     European PICUs for one year. All patients admitted to PICU aged more than 28 days and < 18     years, mechanically ventilated either by endotracheal or tracheostomy tube are included.     Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an     electronic database on the internet. The investigators are going to identify patients, who     presented one or more episodes of VAP during PICUs stay, analysing onset circumstances,     diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence     will be reported as number of events per 1,000 ventilator-days. Risk factors associated to     VAP will be identified by univariate and multivariate analysis.      Results and perspective : the investigators aim to define for the first time the incidence of     VAP among European PICUs with a prospective and multicentre study. The identification of risk     factors, diagnostic methods, epidemiology, treatment strategies will define the basis to     start prevention manoeuvres and improve the clinical strategies for VAP in paediatric     intensive care population.   "
13755|NCT03105401|"     This study aims to describe hallucinations prevalence in a sample of patients affected by     Parkinson's disease and consulting in an outpatient facility.      An unique one hour interview will be offered to volunteers patients. Patients participating     to the study will be asked to answer a semi-structured questionnaire searching for     hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales     will be assessed to search for depressive symptoms, cognitive impairment and specific     personality characteristics.      The study hypothesis is that hallucinations prevalence in Parkinson's disease is     underestimated and is higher than usually described in the scientific literature when all     hallucinations modalities and minor hallucinatory phenomenons are searched for.   "
13757|NCT03105375|"     The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data     following single ascending and multiple ascending doses of X842 in healthy subjects.   "
40518|NCT02755246|"     The overall objective of this study is to examine the effect of polyamine supplementation on     cognitive performance of individuals with subjective cognitive decline.   "
13760|NCT03105336|"     This study will enroll approximately 50 adult subjects who have relapsed or refractory (r/r)     iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease     responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is     made from the subjects own white blood cells which are genetically modified and grown to     fight cancer. An objective response rate of 70% is targeted.   "
13761|NCT03105323|"     This study will be conducted at the In vitro fertilization Unit at Ain Shams University     Maternity Hospital.      Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion     criteria. They will be counseled to be included into the study The study will assess Role of     Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm     Injection outcome.   "
13762|NCT03105310|"     Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and     HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor.      The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated     interferon in patients with chronic HDV infection.   "
13763|NCT03105297|"     To characterize the performance of the nasal dilator strip in lowering nasal resistance     during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep     disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report     trouble with their sleep.   "
13764|NCT03105284|"     The aim of the study is to evaluate a physiological concentration of adipose tissue-derived     stem cells (ASC) in excised fat versus fat harvested by liposuction. Participants will act as     their own control as both extraction methods are performed on each participant.   "
13765|NCT03105271|"     Patients with sickle cell disease may be at risk for acute kidney injury during sickle cell     crisis (pain or acute chest syndrome). This study will evaluate blood and urine biomarkers of     kidney injury during an admission for crisis and during well clinic follow-up.   "
13766|NCT03105245|"     This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the     investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus,     and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a     recording of brain activity during ECT and is used to judge the quality of a seizure and to     guide individual patient dosing).   "
13767|NCT03105232|"     Side effects of opioids can from practical view be divided into short-term and long-term.     Nervous system disorders are manifested by psychological status changes of the patient and     may cause confusion, mental and somatic dependency, dizziness and so on. Influencing the     vegetative and cardiovascular system hypotension can occur what is manifestation of     vasodilation and decreased myocardial inotropic activity. Another clinical sign is     bradycardia and is characterized by general weakness, sweating, collapse can develop. Effects     of opioids may cause respiratory depression, bronchospasm and bronchoconstriction. Side     effects on the gastrointestinal tract are nausea, vomiting, constipation and less frequently     dry mouth. The constipation does not develop tolerance and has to be avoided (dietary     modification, laxatives prevention) respectively during long-term opioid treatment     obstipation should be affected by blocking peripheral opioid receptors in the     gastrointestinal tract by application of an opioid antagonist methylnaltrexone, which does     not cross the blood brain barrier, or using naloxone, which is metabolized by first-pass     metabolism in the liver for example combined preparation containing oxycodone and naloxone     (Kulichová, 2012). Known side effects on parenchymatous organ especially on liver is     restricted biliary excretion caused by spasm of the biliary tract. Skin manifestations caused     by the effects of opioids are urticaria, dermatitis, and pruritus. Renal and urinary     disorders may develop as urinary retention and ureteral spasm. Rarely can occur disorders of     the immune system, which through the development of hypersensitivity may lead to the     development of anaphylactic shock (Kulichová, 2012). Opioids have a negative effect and the     endocrine system. Various studies have demonstrated the influence of opioids on regulatory     mechanisms. Fundamental changes occur in hypothalamic-pituitary complex, which directs the     activities of all the endocrine system. Secretion of hormones of the pituitary gland     regulates the nervous system through the hypothalamus, which is the coordination center of     autonomic function. The pituitary gland has coordinating function in relation to other     endocrine glands, and by production of their hormones affects the peripheral endocrine organs     and the targeting tissues (Kulichová, 2012), (Colameco, 2009).      Opioids decrease the secretion of gonadotropin-stimulating hormone, resulting in reduced     levels of luteinizing hormone. The result of these changes is reduced secretion of     testosterone and estradiol what results in symptoms of hypogonadism. Chronic administration     of exogenous opioids decreases the levels of adrenocorticotropic hormone and cortisol, as     well as their circadian rhythms. The result is a reduction in the response to stress. Effect     on prolactin is not entirely clear. Opioids can stimulate the hypothalamus through the     thyroid stimulating hormone, which may cause prolonged and increased response to opioids in     patients with hypothyroidism. Chronic use of opioids is associated with weight gain,     hyperglycemia and diabetes can worsen (Kulichová, 2012). It may be related to central effects     through the sympathetic nervous system and impaired insulin secretion. New laboratory     measurements show the development of oxidative stress in patients receiving morphine and     related drugs (Merdin, 2016).      The consequences of these biochemical changes further negatively affect the clinical outcome     of the patients. They may become predisposed to excessive progression of previously latent     diseases whose manifestations in patients previously were not apparent and there is emergence     of new diseases. The present data are essential to create a clinical prospective     observational studies to clarify this issue and its conclusions would be essential for new     therapeutic options for adjuvant therapy in patients suffering from chronic pain.   "
13768|NCT03105219|"     To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with     type 2 diabetes and coronary heart disease.   "
13769|NCT03105206|"     This study centers on the treatment of low pole renal stones by flexible ureteroscope and     intends to find the key anatomical parameters using a prospective, randomized multi-center     trial design and to make a more appropriate standard for flexible ureteroscopy of low pole     renal stones.   "
13770|NCT03105193|"     The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine     (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan     to run a 2 group randomized, double blind, clinical trial which will look into morphine     consumption as the primary outcome.      Group 1 (IV lignocaine)- IV bolus of lignocaine and a 3 day post operative IV lignocaine     infusion. Intra peritoneal (IP) bolus of normal saline + 3 day post operative IP normal     saline infusion      Group 2 (IP lignocaine)- IV bolus of normal saline and a 3 day post operative IV normal     saline infusion. IP bolus of lignocaine + 3 post operative IP lignocaine infusion   "
13828|NCT03104439|"     This research study is studying a combination of drugs with radiation therapy as a possible     treatment for Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, or MSI High     Colorectal Cancer.      The interventions involved in this study are:        -  Nivolumab        -  Ipilimumab        -  Radiation Therapy   "
13771|NCT03105180|"     Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation.     However, little is known about the dose-response relationships of hemodilution. The     investigators have therefore performed the present study to measure the effect of a mixture     of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the     hemodilution level using a rotational thromboelastometry (ROTEM®) tests.   "
13772|NCT03105167|"     Transforaminal lumbar interbody fusion (TLIF) had been favorable for effectively decrease     pain and disability in specific spinal disorders; however, there has been concern regarding     pedicle screw placement during TLIF surgery. Recently, several biomechanical studies had     demonstrated that CBT technique achieves screw purchase and strength equivalent to or greater     than the traditional method. Furthermore, Only 1 report examined the surgical outcomes of     TLIF with CBT screws fixation compared with TLIF using traditional pedicle screws fixation.     TLIF with CBT screws fixation may be effective for specific spinal disorders, but the     evidence supporting this possibility is still limited.   "
13773|NCT03105154|"     Evaluate wound healing using Prevena compared to standard dressings in high risk patients     after vascular surgery.   "
13774|NCT03105141|"     This prospective, randomized, single-center clinical trial is designed to figure out the most     optimal algorithm of remote ischemic conditioning on patients with chronic cerebral ischemia.   "
13775|NCT03105128|"     The purpose of this study is to evaluate the efficacy and safety of risankizumab versus     placebo during induction therapy in subjects with moderately to severely active Crohn's     disease (CD).   "
13776|NCT03105115|"     Intravenous infusion of dexmedetomidine during procedure was known to be associated prolonged     duration of spinal anesthesia. In patients receiving dexmedetomidine infusion during     procedure, it has been not evaluated whether use of adjuvant intrathecal fentanyl had     additional prolonging effect on duration of spinal anesthesia or not. Therefore, the     investigators planned this trial to compare clinical outcomes in patients receiving spinal     anesthesia with heavy bupivacaine only and heavy bupivacaine plus fentanyl adjuvant.   "
13777|NCT03105102|"     The study consists of 3 sub-studies, as follows:        -  Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the          efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects          with moderately to severely active Crohn's disease (CD) who responded to risankizumab          induction treatment in Study M16-006 or Study M15-991        -  Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and          safety of two different dosing regimens for risankizumab as maintenance therapy in          subjects who responded to induction treatment in Study M16-006 or Study M15-991;        -  Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of          risankizumab in subjects who completed Sub-study 1 or 2.   "
13779|NCT03105076|"     Both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar     survival rates in breast cancer. These two treatment strategies have diverted cosmetic     outcome and convenience. Thus, shared decision making (SDM) is necessary to aid patients to     choose an appropriate treatment that suits thier needs. We have developed a decision aids     (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on     cancer patients. The measurements include a battery of interview-based questionnaires and     evaluations of decision regret and postsurgical depression. We expect the DAs would benefit     the intervention group in the aspects of knowledge, communication and anxiety status during     and after thier treatment sessions.   "
13780|NCT03105063|"     The anatomy of the acetabulum is well described in the past literature, yet the understanding     of the clinical importance of the anatomical morphology of the AIIS has grown in recent     years. Hetsroni et al. (2013) proposed a morphological classification of AIIS. In this     classification, three types AIIS are identified based on the relationship between the distal     extension of the acetabular rim and the AIIS. Unfortunately classifying the morphology of the     AIIS using standard AP pelvis examination is misleading and requires additional imagery, a     specific radiographic projection - false profile pelvis or 3d imaging techniques such as CT     or MRI.      The objective of this study is to evaluate AIIS morphology using ultrasound as compared to     golden standard (MRI)   "
13781|NCT03105050|"     In recent years more and more collaboration between hospitals performing bariatric surgery     occur and more exchange of knowledge on pre and postoperative care is shared. Different     countries have many different protocols to select and guide patients through bariatric     surgery, and even within countries differences exist. These are most commonly based on expert     opinions and cultural influences. Although many outcomes of the different approaches are     known, the pathways the patient has to take and the accessibility to bariatric surgery are     unclear for each country as well as how the care for these patients is financially arranged.     As a progressive research collaboration, we would like to gain more insight into these     different approaches. With this study we would like to gain more insight into the     accessibility and restrictions to accessibility to both bariatric surgery and body contouring     surgery after massive weight loss that exists in all 51 European countries, as well as why     this disparity exists.   "
13782|NCT03105037|"     Prospective, observational, non-interventional study that will examine if the insertion of a     Supraglottic airway will increase accuracy of identifying the cricothyroid membrane   "
13783|NCT03105024|"     Self-efficacy refers to the perceived belief to cope effectively, by personal efforts, with     challenging situations and problems (Bandura, 1977). Basic research has shown that increases     in perceived self-efficacy can enhance the extinction of fear (Zlomuzica et al., 2015). This     study is aimed at translating these findings into a useful clinical application to augment     exposure-based treatment outcome.   "
13784|NCT03105011|"     This study is designed to see if rural patients with type II diabetes interacting with their     clinic staff by providing daily updates of blood glucose levels will improve glucose control.   "
13785|NCT03104998|"     To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility   "
13786|NCT03104985|"     The aim of this study was to evaluate comparatively the efficiency of traditional treatment     methods in patients with chronic venous diseases of C6 class, and a new combined low level     laser therapy (LLLT) by LASMIK device.      The results of outpatient examination and treatment of patients with venous trophic ulcers,     observed in the City Polyclinic of Tula Municipal Clinical Hospital №2 were analyzed.   "
13787|NCT03104972|"     The possibility of influencing brain activity and steadily enhancing behavioral performance     through external intervention has long fascinated neuroscientists. One of these techniques,     transcranial electrical stimulation (tES), has received great interest. Transcranial     electrical stimulation (tES) in the current research includes two types of stimulation:     transcranial direct current stimulation (tDCS) and transcranial random noise stimulation     (tRNS).      The tES techniques involve the application of constant weak direct current (e.g. 1-2 mA) to     the brain via skin-electrode interface, creating electric field that modulates neuronal     activity. The safety profile of tES is excellent.      Despite effective pharmacotherapy for ADHD there is a need for improvement of cognitive     dysfunction and behavioral symptoms that are only inadequately covered by pharmacological or     psycho-social interventions. Since ADHD is the most common neurodevelopmental disorder in     childhood with significant negative lifetime outcomes, non-invasive brain stimulation methods     have been investigated in childhood and adolescents neuropsychiatric disorders showing     promising results.      If tES is significantly effective for certain symptoms of ADHD, it may offer many advantages     as a therapy. Treatment of ADHD with non-invasive brain stimulation has recently been     reviewed in the medical literature, concluding that this technique seems to have efficacy in     ADHD, however, standardized study protocols are needed to determine it.      In this study we intend to further examine the efficacy of tDCS and tRNS for children with     ADHD and its effect on ADHD symptoms, memory, executive functions, in a randomized controlled     crossover study.   "
13799|NCT03104816|"     Simple explanation and rationale:      Recovery after spine surgery is usually accompanied by severe pain which has traditionally     been managed with opioids. It is common practice to supplement opioid treatment with     different classes of analgesics which work through alternative pain pathways and receptors in     order to achieve an additive or synergistic effect while reducing the amount of opioids     necessary for pain control.      Acetaminophen can be a beneficial supplemental analgesic to opioids for postoperative pain     relief.      Intervention:      Patients will be randomized to either the treatment with IV acetaminophen (A), PO     acetaminophen (B), or hydromorphone control group (C).      Objective/Purpose:      Primary objective is to determine the impact of administering a supplemental non-opioid     analgesic drug such as IV or PO acetaminophen on total opioid dose administered over the     perioperative period.      Secondary objectives include investigating the impact of IV/PO acetaminophen on the level of     postoperative pain, patient satisfaction, and side effects secondary to opioids such as     nausea, vomiting, pruritus, sedation, respiratory depression, ileus, and urinary retention,     and PACU discharge time.      Study population:      126 patients will be enrolled in the study (42 for group A, 42 for group B, and 42 for     control group C).      Follow-up and Endpoints / Outcomes:      Postoperative assessments will be done at 0, 30, and 60 minutes, 6 hours, 12 hours and 24     hours after surgery. Patients will be evaluated for pain (using a numeric rating scale),     total opioid consumption, and for opioid side effects including drowsiness (using the Ramsey     sedation scale and the Aldrete score at the time of arrival to and discharge from recovery     room), respiratory depression, nausea, vomiting, and pruritus. Patient satisfaction will also     be assessed using a numeric rating scale.   "
14805|NCT03091673|"     This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes.     Subjects will be administered insulin to induce a low normal glycemic state and will then     receive an age-appropriate dose of G-Pen™ (glucagon injection) in a clinical research center     (CRC) or comparable setting.   "
13788|NCT03104959|"     This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers     over the age of 21. Consent is obtained prior to participation in the study while the     participant is sober. Volunteers are recruited from residency programs, hospital employees,     emergency medical personnel, and friends of the study investigators. If the volunteers choose     to drink, they can participate in the study the night of ingestion of alcohol. There is no     amount we ask them to drink, and we allow them to withdraw from the study at any time. We     never force them to drink alcohol, or even encourage it. The participation is completely     voluntary, if they would like to participate and if they choose to drink alcohol, we ask them     to participate in the placebo controlled study in the safety of their own home. Then     materials for the study are given out prior to their participation. An envelope is given with     the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a     small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol     ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1     capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In     the morning, each participant fills out a Hangover Symptom Score questionnaire . A random     number generator is used to determine placebo or NAC first, then the participant is given the     other treatment at their subsequent encounter. Then study is being conducted over a series of     many months, and data can be analyzed by the hangover symptoms scale data when using NAC     compared to placebo. The data will be analyzed using the numerical values of each category     for hangover classification and compare the placebo data to the control data.   "
13789|NCT03104946|"     From November 2014 to October 2015, a multi-centers retrospective study was conducted to     collect compliance, and 8 three-level hospitals from China were included. The infants     survived to a postmenstrual age of 36 week with birth weight less than 1500g and without     congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death,     cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to     observe the relationship between morbidities and poor outcomes. And the predictive effect on     the number of the top three morbidities were analyzed by Logistic regression analysis.   "
13790|NCT03104933|"     This study evaluates the usefulness of pro-adrenomedullin (precursor of a vasodilatory     peptide involved in septic shock pathogenesis) and copeptin (a stable peptide of the arginine     vasopressin precursor) to predict, at the moment of septic shock diagnosis or their changes     at 6 hours, the vasopressor requirements (measured by inotropic index and vasopressor     dependency ratio) and volume requirement for resuscitation.   "
13791|NCT03104920|"     The worldwide introduction of multimodal enhanced recovery programs has also changed     perioperative care in patients who undergo liver resection. This study will be performed to     assess a comprehensive care package for patients with hepatocellular carcinoma (HCC)     undergoing hepatectomy with the aim of minimal physiological disturbance in the     peri-operative period. Peri-operative opioid-sparing analgesia with few gastrointestinal (GI)     effects and reduced requirement for intravenous fluid therapy, early ambulation and promoted     GI function recovery were centered to this plan.   "
13792|NCT03104907|"     The aim of this study is to investigate the safety and efficacy of prostatic artery     embolization of patients with recurrent symptoms secondary to locally advanced prostatic     cancer including pelvic pain, bleeding or need for permanent urinary catheter who are unfit     for or refuse surgical treatment.   "
44980|NCT02696902|"     Clinical Trial looking to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically     Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas     aeruginosa   "
13793|NCT03104894|"     The study aims to investigate whether combined treatment of MGD massage and artificial tears     will improve signs and symptoms of dry eye compared to artificial tears alone.      The meibomian glands secrete meibum which is the oily component of the tear film layer. The     meibum plays a pivotal role in preventing tear evaporation and smoothening the tears film .      Meibomian gland dysfunction is a common condition that affects 39%-50% of the population. It     is part of inflammatory disease of the eyelids called blepharitis. Associated syndromes are     rosacea and dry eye syndrome .      Sign and symptoms are: irritation, hyperemia, burning sensation, photophobia, epiphora and     blur.      Spectrometry analysis shows change it the fatty acids conformation such as increase in levels     of branched-chain fatty acids and decrease in saturated fatty acids .      Subsequently the clotted meibum results in glands blockage that can be graded in 0-4 grade     scale: grade 2- meibum secretion thick and oily, grade 3- meibum secretion     granular-toothpaste like.      Although MGD is not often accompanied with inflammatory signs it is a common cause for     evaporative dry eye.   "
13794|NCT03104881|"     Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension     exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)   "
13795|NCT03104868|"     The investigators will evaluate a technology-enabled strategy designed to promote medication     adherence, routinely monitor regimen use, and mobilize appropriate transplant center     resources to respond early to kidney transplant recipients demonstrating inadequate     adherence.   "
13796|NCT03104855|"     The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard     pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic     clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of     this work is to provide the first comprehensive characterization of vitamin D metabolism in     CF patients and promote novel hypotheses for subsequent studies.   "
13797|NCT03104842|"     A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and     maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and     Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients   "
13798|NCT03104829|"     This study evaluates the effect of diabetic knowledge and self care behavior (DSME) alone or     DSME plus motivational interviewing on glycemic control among children and adolescents with     DM type 1. Half of participants will receive DSME along, while the other half will receive     DSME plus MI.   "
13800|NCT03104803|"     The investigators have recently shown in incomplete SCI patients that long-term paired     associative stimulation is capable of restoring voluntary control over some paralyzed muscles     and enhancing motor output in the weak muscles (1). In this study, the investigators will     administer long-term paired associative stimulation to patients with incomplete SCI of     non-traumatic origin.   "
15822|NCT03078387|"     This study shows how careful ophthalmic examination of two patients showed signs of     simultaneous bilateral retinal emboli. Starting from this point significant, life     threatening, underlying reasons were found and treated.   "
13801|NCT03104790|"     LAIV shedding studies in children could be an important way to confirm whether impediments to     viral replication do indeed explain these observed reductions in vaccine effectiveness(VE),     whether prior vaccination has any influence on replication and what future implications (if     any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children     will be dependent on virological and host factors. The virus factors include replicative     fitness of individual strains and the susceptibility to inhibition by other replicating     strains (ability to compete). Host factors which may influence this include pre-existing     specific immunity as a result of prior infection or previous vaccination (with either LAIV or     IIV), and innate immune factors including mucosal immunity. Understanding the relative     importance of different factors over two seasons when the strain composition of the     A/H1N1pdm09 LAIV virus will change and by comparing previously unvaccinated and highly     vaccinated groups (with both LAIV and IIV), can potentially give unique insights into their     contribution to the US LAIV observations.      With the change of the A/H1N1pdm09 vaccine strain in 2017/18, demonstrating improved     performance (in terms of VE, virus shedding and immunogenicity) and what contribution prior     vaccination might make will be key evidence for both the UK, but also the US. Information     presented at the ACIP in June 2018 from the 2016/17 and 2017/18 seasons will be key to inform     US future decisions around use of LAIV.      This is a parallel group, non randomised study which will enrol at least 400 children. Both     written informed consent from parent/ guardian and written assent from the child will be in     place prior to any study procedure. The two groups will be defined by previous influenza     vaccination history, with around half the children naïve to any influenza vaccination (LAIV     or IIV) and half having had at least three doses of LAIV with or without IIV. All will follow     the same schedule of vaccination and oral fluid collection at day 0 (by the nurse in the home     or at the GP surgery); nasal swab collection (by the parent at home on days 1,3,6); day 21     oral fluid collection (by nurse or parent at home or at GP surgery).   "
13802|NCT03104777|"     Public Health England's (PHE) Behavioural Insights Team are leading and fully funding a     randomised controlled research trial in collaboration with Derby City Council's Public Health     Team and the Health and Social Care Research Centre at Derby University to test an     intervention designed to help families provide healthier packed lunches for Primary School     aged children.   "
13803|NCT03104764|"     The aim of the study was to compare the outcome in terms of wound healing time, surgery time,     bleeding and patient experience of the ectomy of frenulum when performed with laser     technology versus conventional scalpel technique. A prospective, single-blind, randomized and     controlled study was performed. Wound healing was assessed five and ten days after after     surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the     study.   "
13804|NCT03104751|"     The primary goal of this study is to systematically describe early neurodevelopment using a     complementary set of observational and neurophysiological measures that may predict cognitive     and motor delays earlier than currently possible for infants with Complex Congenital Heart     Disease (CCHD).   "
13805|NCT03104738|"     Many patients with Type 2 Diabetes Mellitus (T2DM) are currently being managed with Basal     Insulin (BI). However, there is little evidence to support guidelines on dosing adjustments     in the preoperative period. The Society for Ambulatory Anesthesia does not advise a reduction     in the dose of BI preoperatively, unless there is a specific history of hypoglycemia. The     Endocrine Society suggests a 50% reduction in BI dose the evening before surgery. The authors     hypothesized that a 25% reduction in BI dose the evening before surgery will result in better     perioperative blood glucose control compared with our institutional 50% decrease.   "
13816|NCT03104595|"     Part 1 of the study will determine the maximum tolerated dose (MTD) of EC-18 in subjects with     relapsing or metastatic breast cancer whose risk level for febrile neutropenia is low and who     are receiving second line or higher chemotherapy that incorporates     doxorubicin/cyclophosphamide.      Part 2 will evaluate the MTD in the same subject population.   "
13807|NCT03104712|"     Pasta and rice are two of the most commonly consumed grains worldwide, where the former has a     low GI (e.g. spaghetti) and the latter, usually (as it depends on the type) has a higher GI     (e.g. white rice). The most typical ways in which pasta and rice are consumed are with the     addition of oil or tomato sauce, and are recommended to be consumed in this way in the     Mediterranean diet. The Mediterranean diet has been demonstrated to reduce the risk of     cardiovascular disease, improve glycemic control and is encouraged in many clinical     guidelines globally for both cardiovascular risk reduction. Some studies have explored the     differences in glycemic response of different carbohydrate foods consumed with the addition     of fat demonstrating that the glycemic response is indeed reduced.However, the GI may remain     of importance even when other means to reduce glycemic response are introduced.      The investigators therefore designed a randomized controlled crossover study to explore     whether the addition of fat in the form of commonly consumed sauces which are recommended as     part of a Mediterranean diet, affects the difference in glycemic response between a commonly     consumed low GI and a higher GI carbohydrate food.   "
13808|NCT03104699|"     This is a Phase 1, open-label, 3 + 3 dose-escalation trial in subjects with metastatic or     locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in     subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has     progressed after a platinum doublet.   "
13809|NCT03104686|"     Carbohydrate-based products can influence the post-prandial glycemic response differently     based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta     is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature     describe a lower glycemic response after the consumption of pasta compared with other     wheat-based products, such as bread. Among the factors affecting post-prandial glycemia after     consumption of carbohydrate-based products, the technological process represents a central     one. In fact, the different technological processes alter the food matrix which can affect     the post-prandial metabolism of glucose and insulin differently. Thus, the present study aims     at investigating the effect induced by the principal steps of the process of pasta production     on the reduction of post-prandial glycemic and insulinemic responses.   "
13810|NCT03104673|"     Preterm birth (PTB) occurs before 37 weeks of gestation and is a major cause of neonatal     mortality and morbidity. PTB results from heterogeneous influences. One of them is the     inherited predisposition of spontaneous PTB, and another is the change in the placental     microbial composition as this can cause infections, which lead to inflammation, a common     cause of preterm birth. Interestingly, maternal periodontal disease is an independent risk     factor for PTB, low birth weight and fetal growth restriction. Immune responses to infectious     events or inflammation as well as genetic predisposition to inherited conditions have     successfully been studied by using assessing genetic expression profiling. The molecular     signature is sets of genes, proteins, genetic variants or other variables that can be used as     markers for a particular phenotype.      Child morbidity from malnutrition resulting in poor growth and stunting remains a major     public health issue that affects the local population just like PTB. Molecular signatures     including the intestinal microbiome development of preterm infants will be evaluated and     compared to the term (≥37 weeks' gestation) counterparts. Moreover, a comprehensive     examination of possible factors associated with poor growth and poor motor- and     neurodevelopment will be assessed.      In this extension study: The primary goal for the child is to evaluate the perturbation in     the development of the genomic profile including intestinal microbial habitat from children     in a rural and limited-resource setting from birth to two years of life.   "
13811|NCT03104660|"     To evaluate the long-term results after transcatheter mitral valve repair   "
13812|NCT03104647|"     The current study is designed to evaluate neck movements performed according to the     VRP-Clinic software, and to verify that they promote physical activities that correspond with     physical rehabilitation.   "
13813|NCT03104634|"     This short-term study aims to prove the potential cardio-protective physiological effect of     inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures.      Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic     obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large     negative inspiratory pleural pressures, which are transmitted to the surface of the heart and     increase cardiac wall stress.      Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but     the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is     unknown.   "
13814|NCT03104621|"     The aim of this work is to evaluate efficacy and tolerability of preservative containing     0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and     preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. In     addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma     patients.   "
13815|NCT03104608|"     Age-related macular degeneration (AMD) is a condition affecting 20 to 25 million people     worldwide. Symptoms of AMD includes difficulty in reading, recognizing faces and completing     house work which may result in increased disability which in turn increase symptoms of     depression and anxiety. Depression and anxiety could also be worsened by social isolation     caused by AMD. Further, AMD causes high levels of emotional distress and reduced quality of     life (QoL). Automatic Self Transcending Meditation (ASTM) - a standardized category of     meditation - may help reduce stress, depression, anxiety, and may enhance QoL. Automatic Self     Transcending Meditation (ASTM) is a class of meditation that helps quiet the mind and induces     physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound     value (mantra) to draw attention inward and permit the mind to experience a restful but alert     state of consciousness. In the proposed research, the effects of ASTM on health related     quality of Life (HRQoL), depression and anxiety in low-vision AMD patients will be studied. A     single-center, single-blind longitudinal randomized controlled trial (RCT) will be conducted     in London, ON. Patients with AMD (n = 140, 70 in each arm) will be randomized to ASTM plus     treatment as usual (TAU) or TAU alone (control) arm. Data on routinely measured ophthalmic     clinical variables, HRQoL, depression, and anxiety will be collected from both the arms.     Statistical analysis will be conducted using STATA 15.0 to evaluate the effects of ASTM plus     TAU compared to TAU alone on HRQoL, depression, and anxiety. Further, for each group - ASTM     plus TAU and TAU alone - the investigators develop an association between HRQoL, depression,     and anxiety with routinely measured clinical variables using mathematical models.   "
13819|NCT03104556|"     The MitraClip-procedure offers an interventional treatment for high risk patients with severe     symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without     clinical manifestations is high. The aim of this study is to determine the frequency of     cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial     doppler ultrasound and magnetic resonance imaging.   "
13856|NCT03104075|"     This is a prospective, single-site, randomized, then open-label study designed to develop a     detailed transcriptional and epigenetic profile of the immune response to pneumococcal     vaccination with conjugated and non-conjugated polysaccharide vaccines in the senescent     immune system of older adults.      In this study, 40 healthy adults ages 65 and older that have never received pneumococcal     vaccination, will be randomized in a 1:1 ratio to receive Prevnar-13 (Pfizer), a conjugated     13-valent vaccine or Pneumovax 23 (Merck), a non-conjugated 23-valent vaccine. Following     randomized assignment of vaccine, the study will be open-label.      Six (6) study visits will occur over about 70 days, with an optional 7th visit for     participants to receive a second vaccination with the other pneumococcal vaccine one to two     years after randomization. Participants will provide blood samples for transcriptional,     epigenetic and biological analyses pre- and post-vaccination.   "
13820|NCT03104543|"     Survivors of childhood cancer are known to be at higher risk of developing premature, serious     cardiovascular disease compared with the general population. Hypertension, dyslipidemia, and     diabetes increase this risk beyond that attributable to one's original cancer therapy     exposures. Research has shown that childhood cancer survivors also have a high burden of     underdiagnosis and undertreatment of these potentially modifiable conditions. The goal of     this study is to:        1. To determine the prevalence of underdiagnosis and undertreatment of common          cardiometabolic conditions (i.e., hypertension, dyslipidemia, diabetes) in survivors of          childhood cancer at high-risk of future serious cardiovascular disease.        2. Among survivors who are found to be underdiagnosed or undertreated, to determine (via          randomized clinical trial) the efficacy of an educational intervention to improve          control of these cardiometabolic conditions.        3. Determine barriers on among survivors enrolled on the randomized trial and their primary          healthcare providers that contribute to undertreatment of the study's targeted          cardiometabolic conditions.   "
13821|NCT03104530|"     The brown meat from crab may contain high levels of the heavy metal cadmium. Cadmium is found     in the environment and long-term exposure can cause accumulation in the body. High cadmium     levels can be toxic to the kidney and have been statistically associated with an increased     risk of cancer in the lungs, endometrium, bladder, and breast. This study aims to investigate     if regular consumers of brown crabmeat have a higher body burden of cadmium than     nonconsumers. This is important as no other studies that have addressed this subject. The     results of this research may provide guidance on the consumption of brown meat from crab.      The hypothesis of the proposal is that regular habitual consumption of brown crabmeat     increases the body burden of cadmium.      This study will recruit 45 healthy participants who consume brown crab meat and 45 healthy     participants who do not consume brown crab meat. Volunteers will be eligible if they are ages     40 years and older, non-smokers, and have not had significant occupational exposure to     cadmium. Eligibility will be determined using a questionnaire that consenting volunteers will     be asked to complete.      Eligible participants will be asked to attend a study visit at the Rowett Institute or at a     GP practice in Stromness (depending on participant location). Participants will be weighed     and asked to provide a urine sample as well as a 40 ml (2-3 tbsp.) non-fasted blood sample.      The blood and urine samples will be processed at the Rowett Institute or at the Balfour     Hospital in Kirkwall (depending on where the study visit took place). Analysis will be     completed at the Rowett Institute where whole blood will be analysed for cadmium, selenium,     and zinc and the serum for creatinine and ferritin. Urine samples will be measured for     cadmium, B2-microglobulin and creatinine.      Recruitment is expected to take place over 4 months. Study participants will have the option     of receiving feedback on their cadmium, zinc, selenium and ferritin levels.   "
13822|NCT03104517|"     This study evaluates the safety and efficacy of two treatments of Autologous Muscle Derived     Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of     stress urinary incontinence (SUI) in adult female patients. Two-thirds of the participants     will receive AMDC-USR (injections with cells) and the other one-third will receive placebo.   "
13823|NCT03104504|"     SOS will identify evidence based best practices consistent with Zero Suicide's six specific     recommended clinical actions (A.2.) and use them to develop standardized clinical protocols     for each care setting, clinical unit, population serviced, and clinical discipline. Using     Lean CQI, the investigators will tailor, implement, and improve adherence to these protocols.     To support feasibility, SOS will use a phased roll out and a hub-and-spoke design. The     intervention targets will be suicide-related clinician behaviors. The investigators will     aspire to adopt best practices and measure all six recommended performance elements; however,     for feasibility, the research evaluation will focus on suicide risk screening, safety     planning, means restriction counseling, and post-acute care follow-up calls. The primary     patient outcomes will be suicide risk identification, suicide, suicide attempts, and     suicide-related emergencies requiring acute care. The investigators will examine potential     mechanisms of action and moderators, and conduct a cost effectiveness analysis of SOS versus     usual care. The investigators will employ a stepped wedge design and follow individuals for 6     to 54 months. Outcomes, clinician behaviors, and other variables will be gathered through:     (1) EHR data extraction, (2) claims data from UMMHC and the MA All Payer Claims Database, (3)     random medical chart abstractions, (4) MA state vital statistics and National Death Index     (NDI), (5) clinician surveys, (6) Lean evaluations and process observations, and (7) patient     fidelity interviews. Data will be analyzed using generalized linear mixed models.   "
13824|NCT03104491|"     This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this     research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given     to subjects without having too many side effects.      The Phase II portion of this study is to see what side effects are seen with medication after     transplant.      Inotuzumab ozogamicin is a combination of an antibody and chemotherapy. This means that it     targets the acute lymphocytic leukemia (ALL) cell and can deliver the chemotherapy to the ALL     cell. Research shows that in some patients, it has caused their disease to go back into     remission.      Inotuzumab ozogamicin is considered experimental in this study.   "
13825|NCT03104478|"     The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the     objective to send to the local investigator an extensive molecular tumor characterization by     D38 in at least 80% of enrolled patients.      The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide     network of dedicated multidisciplinary platforms.   "
13826|NCT03104465|"     The overall aim of this study is to test the acceptability and feasibility of an interactive,     web-based mindfulness training with active duty soldiers being treated for chronic pain.   "
13857|NCT03104062|"     Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who     underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow,     about 40% have flow alterations in the coronary microcirculation, which leads to worse     remodeling of the left ventricle with a consequent increase in the mortality of this     population. Clopidogrel is the only known antiplatelet medication that brings benefits to the     coronary microcirculation. Ticagrelor is significantly superior to clopidogrel in terms of     decreasing mortality.      The main objective of this study is to compare the effect of ticagrelor versus clopidogrel on     the coronary microcirculation by the Myocardial Perfusion Score Index (MPSI) obtained using     Microbubble Contrasted Echocardiography (MCE) in patients who have STEMI and treated with     thrombolysis.   "
13829|NCT03104426|"     The mainstay of antenatal treatment of fetal anemia due to red cell alloimmunization is     (serial) IUT. The mainstay of postnatal treatment in HDN is (1) intensive phototherapy and     exchange transfusion to treat hyperbilirubinemia and prevent kernicterus, and (2) top-up     transfusions to treat anemia. Up to 80% of infants with HDN treated with IUT require at least     one top-up transfusions for late anemia during the first 3 months of life.      Several risk factors for late anemia have been reported, including serial IUT (due to bone     marrow suppression), severity of HDN, reduced use of exchange transfusions during the     neonatal period and reduced survival of transfused red blood cells. Finally, erythropoietin     deficiency is also considered as a possible contributing factor to late anemia.      EPO has been increasingly used in neonates to prevent or reduce neonatal anemia without short     or long-term adverse effects. Several small studies and casuistic reports suggest that     neonates with HDN may benefit from treatment with EPO to reduce the risk of delayed anemia     and subsequent top-up transfusions. However, other authors found that EPO may be less     effective than expected. Due to the lack of evidence, routine use of EPO is currently not     recommended. To determine a role for EPO in this group of patients, a well-designed     randomized controlled clinical trial of sufficient sample size is required. Potentially, EPO     stabilizes the hemoglobin levels of these infants and thus prevents top-up transfusions and     extra admissions, creating a more stable and natural postnatal course for patients with HDN.   "
13830|NCT03104413|"     The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus     placebo during induction therapy in subjects with moderately to severely active CD.   "
13831|NCT03104400|"     This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to     compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B     QD versus placebo and versus adalimumab every other week (eow) in participants with     moderately to severely active Psoriatic Arthritis (PsA) and have an inadequate response to     non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of ABT-494     Dose A QD and Dose B QD versus placebo for the prevention of structural progression. Period 2     evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in     participants with PsA who have completed Period 1.   "
13832|NCT03104387|"     Ambient air pollution is a complex mixture of gaseous pollutants and particulate matter (PM).     PM has a recognized important role in human health. There is a strong scientific consensus on     the independent association of PM and adverse cardiovascular and respiratory effects, as well     as cancer. It is reasonable to expect that the smaller particles (ultrafine particles, UFP)     may have an enhanced toxicity relative to other PM size fractions, due to physical properties     and potential to translocation beyond the lung.      A recent Danish report concluded that train conductors on a working day, and in two specific     diesel engine trains, are exposed to higher concentrations of diesel exhaust than by constant     stay in a busy street. Indeed, the average exposure for train conductors on such engines was     around 100,000-150,000 UFP per cm3 as compared with around 40,000 per cm3 on a busy street in     Copenhagen [1]. The aim of this study is to investigate if this occupational exposure is     associated with vascular and respiratory impairment and DNA damage.   "
13833|NCT03104374|"     This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to     compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B     QD versus placebo in participants with moderately to severely active Psoriatic Arthritis     (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug     (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and     Dose B QD in subjects with PsA who have completed Period 1.   "
13834|NCT03104361|"     Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating chronic disease of     unknown etiology characterized by urgency frequency and suprapubic pain at full bladder.     Current treatments are usually unsuccessful in completely eradicating bladder pain and     increasing bladder capacity. Autologous platelet-rich plasma (PRP) is growing in popularity     as a therapy to augment wound healing, speed the recovery from muscle and joint injuries, and     enhance recovery after surgical repair. PRP is extremely rich in growth factors and     cytokines, which regulate tissue reconstruction and has been studied extensively among trauma     patients and trauma experimental models. Tissue regeneration can be improved by local     application of autologous bone marrow derived progenitor cells and PRP. This clinical trial     attempts to use autologous PRP in treatment of interstitial cystitis refractory to currently     available medical treatment or intravesical therapy. The results of this study might provide     clinical evidence for a novel therapeutic regimen in the treatment of IC/PBS.   "
13836|NCT03104335|"     Patients with advanced soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded), who     experience progression after standard chemotherapy, have limited treatment options which     promise a survival benefit.This trial tends to explore apatinib, which is a domestic highly     selective inhibitor of vascular endothelial growth factor receptor-2, as a treatment option     for heavily pretreated soft tissue sarcoma patients.   "
13837|NCT03104322|"     Pilot-scale, open-label, randomised, two-period crossover study in idiopathic pulmonary     fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower     platform) to record treatment compliance, forced vital capacity (FVC; daily), impact of IPF     on daily life (weekly) and other symptoms. Objectives are to characterise acceptability of     patientMpower platform from patient & healthcare professional perspective, impact of active     engagement and self-monitoring using patientMpower platform on Patient Reported Outcome     Measures (PROMs) in IPF, impact of patientMpower platform on medication compliance and     correlation between patient-reported PROMs & FVC and clinical outcomes.   "
13867|NCT03103932|"     This is a multi-centre, single blind, randomized study. Patients admitted to hospital with     acute decompensated heart failure will be randomized to biomarker guided discharge algorithm     vs usual care in a 2:1 ratio. NTproBNP and other biomarkers will be measured within 24 hours     of admission. The NTproBNP results will be used to further stratify participants randomized     to the biomarker guided group into lower and medium to higher risk pathways. Biomarkers will     be repeated after 2-3 days and again prior to discharge. Specific care pathways will be     followed for each of the lower risk and medium-higher risk groups. Biomarkers will be     repeated 30 days post discharge. Participants will be followed with a phone call at 3 months     and return for a follow up visit at 6 months post discharge for outcome evaluation.   "
13838|NCT03104309|"     Adenomyosis is defined when the endometrial tissue (gland and stroma) is present within the     myometrium . The depth of endometrial penetration which uses in diagnosis of adenomyosis not     yet agreed; opinions range from one high power field to 25% of the myometrial thickness. It     is a common condition in women aged 40-50 years and is considered an important cause of     dysmenorrhea and menorrhagia in around 65 % of cases.      Until past few years; hysterectomy was the suggested definitive treatment, however; this may     not be acceptable to women not willing to loss their fertility. Many treatment lines were     studied and proved their beneficial effect on adenomyosis such as GnRH agonists, danazol,     combined oral contraceptive pills, dienogest and finally endometrial ablation. However, these     line of treatment are not commonly used because high incidence of side effects and relatively     high cost of some of them.      The levonorgestrel-releasing intrauterine system (LNG-IUS) was emerged as an effective line     for treatment of adenomyosis associated pain and bleeding. It can successfully, within 6 to     12 months, down-regulate the estrogen receptors in adenomyotic tissues which lead to     decidualization and atrophy of the adenomyosis .      In fact, some adenomyotic women respond well to LNG-IUDs and show high acceptability and     satisfaction, on the other hand; a group of women may not respond to LNG-IUDs and opt to     remove it and start a new medical or surgical option for treatment.      However, factors related to LNG-IUS effectiveness in patients with adenomyosis were not well     available. Only one report states that a large uterine volume could be a factor associated     with LNG-IUS treatment discontinuation in adenomyotic patient.      For this reason; the prediction of the responsiveness to LNG-IUS is interesting issue which     should be addressed. The present study examines the hypothesis that patient's data reported     at baseline visit before using LNG-IUSfor controlling pain/bleeding with adenomyosis can help     the prediction of the responsiveness for this important line of treatment at 6 months follow     up visit. Up to our knowledge; no clinical trial had been registered or conducted to predict     the responsiveness for LNG-IUS in controlling the pain/ bleeding with adenomyosis.   "
13839|NCT03104296|"     The recent improvements in neonatal intensive care have led to a substantial increase in the     survival rate of preterm infants; nevertheless, this population is still at high risk for     long-term neurodevelopmental disabilities. Significant anatomical changes in brain structures     and abnormal patterns of neuronal myelination and brain connectivity have been associated     with preterm birth, with possible long-term effects on cognitive, motor and social skills.      The validation of clinical tools able to predict neurodevelopmental outcomes in the preterm     population might help at identifying infants at greatest risk of impairment, who would     benefit most from early supportive interventions exploiting brain neuroplasticity.      Near infrared reflected spectroscopy (NIRS) provides a bedside, non-invasive, continuous     monitoring of cerebral oxygen saturation (CrSO2), which has been proposed as a predictive     marker for later neurodevelopment in neonates undergone cardiac surgery; to date, however,     evidence on the correlation between CrSO2 and later neurodevelopment in preterm infants is     almost lacking.      This study aims to evaluate whether CrSO2 monitoring, performed before NICU discharge in     clinically stable very low birth weight (VLBW) preterm infants, can predict psychomotor     outcomes during the first 24 months of corrected age (ca).   "
13840|NCT03104283|"     The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced     gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and     efficacy of apatinib treatment.   "
13841|NCT03104270|"     Despite the recent introduction of novel anti-multiple myeloma (MM) agents, high risk MM     remains with poor prognosis and a therapeutic challenge. Elotuzumab (ELO) is a humanized     monoclonal antibody that recognizes CS1/CD139, a molecule highly expressed in MM cells. The     ELO (10 mg/kg), lenalidomide (LEN) and dexamethasone (DEX) combination achieves high overall     response rates (ORR) and long progression-free survival (PFS) for patients with     relapsed/refractory disease (RR) MM and those with impaired renal function. However, its     efficacy for MM patients with high risk characteristics is still unknown. Pomalidomide (POM)     is a recently approved immunomodulatory agent (IMiD) that produces response rates for     high-risk RRMM patients when used in combination with DEX and other agents, including the     proteasome inhibitor (PI) bortezomib (BTZ). POM has also demonstrated activity for LEN     refractory patients. Carfilzomib (CFZ) is a potent second generation PI that has shown to be     efficacious for IMiD and BTZ refractory patients as well as high risk patients carrying     cytogenetic abnormalities. In this study, the investigators propose to evaluate efficacy and     safety of ELO in combination with POM, DEX and CFZ for high-risk RRMM patients.   "
13842|NCT03104257|"     The purpose of this research study is to determine the temporal course of recovery of CB1R     availability and neural oscillations, in cannabis-dependent individuals at baseline,     following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence.     This research will also examine associations between CB1R availability, neural oscillations     and cognitive function.   "
13843|NCT03104244|"     The purpose of this study is to determine the neurologic and cognitive effects of playing     tackle football in grade school and high school.      During contact practices and games, players wear a football helmet containing an impact     sensor. Before and after each season, players complete neurological testing to measure     several different aspects of brain function.      Two groups of football players will be in the study:      5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer     league (about 70 players).      Varsity football players from Brighton High School (about 70 players per year).      The study begins in July 2016 and will continue for 4 years (through the winter of 2020).   "
13844|NCT03104231|"     Atrial fibrillation (AF), which is the most common cardiac arrhythmia in adults, is     associated with a high risk of stroke and other thromboembolic complications. The usage of     oral anticoagulation (OAC) may prevent the incidence of the thromboembolic events in the     majority of patients. The current guidelines for the management of AF patients highlight the     important role of patients' education, since the clinical benefit from OAC treatment may be     achieved by the effective cooperation between patients and physicians. It has been suggested,     that compliance may be increased by the novel e-solutions introduced into the daily clinical     practice. Due to the improvement in advanced technologies, the virtual reality (VR)     three-dimensional (3D) movie stands for a future alternative in e-medicine. The aim of the     OCULUS study was to examine whether the 3D movie-based knowledge transfer is effective in     teaching patients about the consequences of AF and pharmacological possibilities in reducing     the risk of stroke.   "
13845|NCT03104218|"     Transcranial direct current stimulation (tDCS), an electrostimulation technique known to     modulate the motor cortex excitability, has been shown to enhance the effects of     rehabilitation in populations with neurological injuries. tDCS could similarly be effective     in individuals with rotator cuff (RC) tendinopathy, as this pathology is also associated with     pain and motor control deficits. For the treatment of RC tendinopathy, sensorimotor training     is effective to reduce pain, increase function and enhance motor control of the shoulder. The     addition of tDCS during sensorimotor training could enhance motor learning associated with     sensorimotor training and thus improve treatment outcome. PURPOSE: To compare, in terms of     symptoms, functional limitations and shoulder control, a group receiving a rehabilitation     program centered on sensorimotor training combined with tDCS to a group receiving the same     rehabilitation program combined with sham tDCS in individuals with RC tendinopathy. METHODS:     Forty adults with RC tendinopathy will take part in the 4 evaluation sessions (0, 3, 6, 12     weeks) and a 6-week rehabilitation program. Outcome measures will be symptoms and functional     limitations (Disability of the Arm, Shoulder and Hand and the Western Ontario Rotator Cuff     index), as well as acromiohumeral distance ([AHD] ultrasonographic measurement at 0° and 60°     of elevation arm). The rehabilitation program will include sensorimotor training,     strengthening and education. tDCS will be apply during sensorimotor training on the motor     cortex contralateral to the side of pain. A 2-way ANOVA will be used to analyse the effects     of tDCS on the outcomes.   "
13846|NCT03104205|"     The goal of this study is to conduct a program of pilot research aimed at developing and     evaluating a technology-assisted wellness intervention for older adults with obesity.   "
13847|NCT03104192|"     The goal of this study is to conduct a program of pilot research aimed at developing and     evaluating a technology-assisted wellness intervention for older adults with obesity.   "
13848|NCT03104179|"     In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release     of cytokines during immunological response.      They are induced by different types of inductors ( intrinsic and extrinsic). High levels of     inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours     of surgery.      Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These     changes lead to rheology impairments.      These strong reactions lead to dysfunction of different organs possibly culminating in a     multi organ failure.      There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB     with a rate of about 30%. Dysfunctions of organ function are often connected with increased     mortality, prolonged mechanical ventilation , septic complications, increased catecholamine     dosages and prolonged length of ICU stay.      Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the     circulating cytokine levels during and after CPB and lead to a diminished inflammatory     response, acute phase reaction as well as reduction of organ failure.   "
13849|NCT03104166|"     50 patients will be randomized and treated with MCO or highflux dialysis for six months (24     weeks) after a run-in phase of 4 weeks Highflux treatment.      Serum samples will be drawn at baseline, after 4, 8 and 24 weeks.      Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples     and calcification will be assessed with Alkaline phosphatase and Alizarin staining.      Primary endpoint:      In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8)     after six months      Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after     six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase     and WST8.      Secondary Endpoints:      Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical     activity level after 6 months      Cell culture: Incubation of VSMC with serum samples obtained after 6 months        -  Alizarin staining/WST-8        -  Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in          Supernatants        -  Apoptosis      The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow     as well as dialysis time will remain constant.   "
13850|NCT03104153|"     To compare early drain removal versus output-based drain removal, assessing the following     end-points:      Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain     output versus volume of seroma.      Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance     and implications on daily activities.      Cost-effectiveness   "
13851|NCT03104140|"     The aim of this work is to compare two protocols (ketamine-fentanyl-midazolam versus     thiopental-fentanyl-midazolam) for induction of anesthesia in patients with septic shock     aiming to find the most safe protocol with regards to hemodynamic status of patients.   "
13852|NCT03104127|"     This study will investigate if a lower limb robotic device can be used in a community setting     to increase the amount of physical activity that individuals undertake following stroke and     consequently improve biomechanical, physiological and health outcomes, in patients with     stroke.   "
13853|NCT03104114|"     Boston Medical Center provides care to cancer patients on oral cancer medications through the     use of Boston Medical Center Specialty Pharmacy (BMC SP). The use of oral medications in     cancer treatments is relatively new and unfortunately, very little is known about adherence     in cancer patients. This study will evaluate the influence of a pharmacist-driven medication     management program on adherence and persistence rates. Boston Medical Center's Specialty     Pharmacy Adherence Program (B-SPAP), will utilize a high-touch counseling model involving     clinical pharmacist that will focus on educating patients about their oral cancer treatments.     The program will require face-to-face counseling with a pharmacist, through the use of a     proven patient teaching tool, prior to initiating treatment with oral oncolytic treatments     and, periodically thereafter, based on protocol. This study will help improve our     understanding of the role of the pharmacist in cancer patients. In addition, the study will     help identify independent factors that may contribute or impact adherence. The outcomes of     this program will be compared to a historical control group of patients that have already     received treatment for their cancer through the BMC Specialty Pharmacy.   "
13854|NCT03104101|"     This study was done to verify whether the combination of transcutaneous posterior tibial     nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with     overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral     therapy.   "
13855|NCT03104088|"     Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.   "
13858|NCT03104049|"     Parkinson's disease (PD) is a degenerative disorder characterized by a symptom triad     consisting on: tremor, rigidity and bradykinesia . To these symptoms it is often added     postural alteration that can stand in two different attitudes, such as the camptocormia and     the syndrome of Pisa . Progressing in its evolution, PD becomes increasingly disabling,     making it difficult or even impossible daily activities such as washing or dressing.The     abnormal posture, with alteration of the limbs, the neck and trunk, is a recurring feature in     PD, with a frequency of about 30%. Between 2% and 12.3% are more severe abnormalities such as     camptocormia, the syndrome of Pisa and the anterocollis. Several studies disease plug in     Neuromuscular Taping technique (NMT) among rehabilitative tools in degenerative neurological     syndromes.      To the best of our knowledge, no applications were found in PD. Therefore, the current study     was designed to evaluate quantitatively the effects of the NMT intervention on the trunk     kinematics during standing position. More specifically, this study aims to compare the trunk     kinematic variables of patients with PD who were treated with effective NMT versus those of     the subjects who received only the pharmacological treatment.   "
13859|NCT03104036|"     The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories     of UC pathogenesis represents a pathological response of mucosal immunity to intestinal     microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota     transplantation (FMT). Review of the literature on FMT suggests great potential as the     treatment for UC, but two prospective controlled study that has been published yet are     inconsistent.      The first objective of the project is to compare the administration of FMT enema with     mesalazine enema for inducing remission in patients with active left-sided UC in the form of     a prospective, randomized, controlled study. The second objective is to observe changes in     the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to     identify the bacterial species which are responsible for the effect of the FMT.   "
13860|NCT03104023|"     Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one     group, a staple line inversion with a running suture of Polypropylene will be performed. In     the second group, the gastric section will be performed with a stapler with preloaded     buttress material      Postoperative nausea and vomits during the first 24 hours will be investigated.   "
13861|NCT03104010|"     This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD,     preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence     for the medication dosage in Phase 2 clinical study.   "
13862|NCT03103997|"     Since its inception, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has proven a     valuable diagnostic and prognostic tool for evaluating a diverse number of pathologies. One     such pathology is chronic liver disease (CLD), for which EUS-guided liver biopsy has become a     well-accepted method for tissues acquisition. EUS-LB also been compared with percutaneous and     transguluar routes showing at least comparable ability to obtain adequate tissue for CLD.      Though enhancements to EUS-FNA, such as dry suction, stylet pull have not proven to     demonstrate increased diagnostic accuracy for EUS-FNA, the use of wet suction technique     (WEST) has demonstrated the ability to obtain more cellular tissue samples with less blood     contamination. In an attempt to obtain further improvement in tissue adequacy, with less     blood contamination for EUS-LB, the use of wet heparinized needles will be investigated as     compared with conventional EUS-LB for patients with CLD. To do this subjects shall be     selected to undergo EUS-LB. As it is the standard to perform 3 needle passes during EUS-LB,     subjects will undergo one pass with the following designations: pass 1: conventional EUS-LB     [no flush], pass 2: dry heparin heparin [5 milliliters (mL) of heparin flushed and then     flushed with air], and pass 3: wet heparin [5 milliliters (mL) of heparin flushed and     retained in the needle]. It is predicted that specimens collected with heparinized needle     shall show improved adequacy compared with conventional EUS-LB. It is also predicted that the     heparin wash will lead to less blood contamination compared with conventional methods.     Subjects shall also be monitored for adverse events (AE).   "
13863|NCT03103984|"     The main goal of this project is to evaluate the effect of immunosuppression in the weight     loss and in the metabolic status of patients after liver transplantation. It is also the     purpose of this project to investigate why patients become overweight and obese after liver     transplantation.   "
13864|NCT03103971|"     This phase I trial studies the side effects of autologous anti-CD19chimeric antigen receptor     (CAR)-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ T-lymphocytes (huJCAR014) in treating patients     with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia.     huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells     and may specifically kill cancer cells that have a molecule CD19 on their surfaces.   "
13865|NCT03103958|"     The probiotic for oral use, Probiatop®, consists of Lactobacillus acidophilus NCFM,     Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis     HN019. Its activity will be compared with placebo (Maltodextrin). The metagenomics data will     be correlated with the Quality of Life Questionnaire answers obtained from participants with     intestinal transit problem. The Increase in the number of evacuations, as well as the     improvement of complaints related to intestinal transit alteration will be evaluated during     the study. The participants will use probiotic or placebo for a period of 28 days and the     gastrointestinal function questionnaire and collect stool will be performed before the study     and after period of treatment   "
13866|NCT03103945|"     This observational study evaluates peri-procedural results of the Niobe™ Remote Magnetic     Navigation (RMN) ES system using the contact detection system (CDS) in patients undergoing     standard of care radiofrequency ablation of cardiac arrhythmias.      The objective of this observational study is to confirm system performance of the CDS and     that it does not alter pacing, electrocardiograms, or mapping during RF ablation procedures.   "
13871|NCT03103880|"     The purpose of the study is to determine the feasibility and acceptability of at-home use of     the Cohero mHealth (mobile health) technology, which consists of a Bluetooth Low Energy     connected medication-use sensor (HerotrackerTM) that monitors at-home medication use, mobile     application (BreatheSmart) that sends real-time reminders, and mobile spirometer     (mSpirometer) that measures lung function, through a virtual observational study format in     order to improve patient engagement with the platform for sustainable use and motivate     subjects to self-manage their disease.   "
13872|NCT03103867|"     The study is an open label single centre randomised cross over study to evaluate the impact     of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin     administration (640G® with the Smart Guard feature) versus the use of the same pump for     insulin administration with 'only' continuous glucose measurements (not interacting with the     pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia.     Exploratory endpoints are the effect on sleep and quality of life in children with type 1     diabetes and their caregivers.   "
13873|NCT03103854|"     This is a 2x2 study examining the impacts of a novel exercise regimen and daily text message     reminders in patients at high risk for cardiovascular disease. Patients participating in     cardiac rehabilitation will be randomized to either moderate intensity continuous training     (MICT) or a novel exercise regimen consisting of three periods of high intensity exercise,     called BURST exercise. Additionally, half of the patients in each exercise group will be     randomized to receive daily text message reminders to improve adherence to the prescribed     exercise regimen.   "
13874|NCT03103841|"     Obstructive sleep apnoea (OSA) is a condition that affects around one in 20 children. In     children with OSA, repeated episodes of airway obstruction can severely disturb and fragment     sleep, leading to subsequent cognitive and behavioural problems .      Epilepsy affects 60,000 children in the UK and up to 30% of children with epilepsy have     learning problems. Evidence suggests that OSA is more common in children with epilepsy, such     that sleep disturbance could account for some of the learning problems they experience.      The aim of this study is to determine the prevalence of OSA in children with epilepsy. The     investigators plan carry out detailed sleep studies in children with epilepsy and healthy     controls to determine if children with epilepsy are more likely to have OSA than healthy     children of the same age.      OSA is almost always treatable and the benefits of detecting and treating the condition in     healthy children are well-established. If OSA proves to be a common finding in children with     epilepsy, it will be important to carry out further studies to see if treating the condition     has beneficial effects on learning and behaviour. This project could lead doctors to target     sleep-disordered breathing as a way of improving learning outcomes in children with epilepsy.   "
13875|NCT03103828|"     The purpose of this study is to figure out the best way to help veterans do advance care     planning. This study will examine the effects of two theory based behavior interventions by     randomizing veteran into 4 groups to see which veterans will complete the 4 step process of     advance care planning.   "
13876|NCT03103815|"     The primary objectives of this study are to determine the safety and efficacy of Amivita, a     compound of amino acids and vitamines in patients with Amyotrophic lateral sclerosis     (ALS)ALS. The secondary objectives are to measure quality of life before and during     intervention. This is a self-controlled clinical trial. Twenty patients in our ALS center who     are already receiving riluzole or other treatments but the condition is worsening will     receive treatment for 1o months. The evaluating investigators will be blinded to treatment     assignment. Primary outcome measures will be adverse events, the ALS Functional Rating     Scale-Revised (ALSFRS-R), and survival. Subjects will also be assessed at enrollment and at     study end for weight loss, forced vital capacity (FVC), quality of life and grip strength.   "
13877|NCT03103802|"     This study is to compare the diagnostic accuracy of digital models obtained via 10     digitization techniques to the reference standard of orthodontic plaster model through dental     measurements   "
13878|NCT03103789|"     The objective of this study is to design and use a novel, minimally invasive mucosal     impedance (MI) technology to inexpensively and accurately test mucosal health in suspected     gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as     compared to those without GERD.   "
13879|NCT03103776|"     Autoimmune thyroiditis and goitres are frequent pathologies. On a predisposing genetic     ground, environmental factors are potentially at their origin. Viral infections are the main     factors involved in autoimmunity (herpes virus, viral hepatitis C, Erythrovirus B19 ..).     However some viruses have an oncogenic potential and could be involved in goitrigenesis. It     is also possible that some viruses are specifically implicated in the pathogenesis of Graves'     disease or Hashimoto thyroiditis which combines goitre and autoimmunity.      The intrathyroidism of the viral genome of a polyomavirus, the BK virus, has recently been     reported in patients with goitre or cancer. The BK virus is a small ubiquitous virus of 40 nm     diameter with double-stranded DNA contained in a non-enveloped icosahedral capsid. It is     mainly known for triggering renal and bladder pathologies including urothelial tumors in the     immunocompromised patient, tubulo-interstitial nephropathy in the renal transplant patient,     as well as hemorrhagic cystitis in the patient grafted to the bone marrow.   "
13880|NCT03103763|"     This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the     very old and attempt to identify risk factors which may impede safe and effective     anticoagulation.   "
13881|NCT03103750|"     Specific Aim 1: As part of a within-subject, two-days, study design, to determine whether     acute calcitriol (vs. placebo) pre-treatment is associated with greater amphetamine     (Amp)-induced dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and     substantia nigra / ventral tegmental area (SN/VTA) of healthy human subjects.      Specific Aim 2: To determine whether acute calcitriol (vs. placebo) pre-treatment is     associated with better performance on a test of attention (e.g., the continuous Performance     Task or CPT-AX), after treatment with amphetamine. Hypothesis: Investigators hypothesize that     Subjects pre-treated with calcitriol will have faster reaction times/higher accuracy on the     CPT-AX vs. subjects pre-treated with placebo, after treatment with amphetamine.   "
13882|NCT03103737|"     The aim of this study is to test the efficacy of a brief psychological intervention composed     by two therapeutic modules (virtual environments and reminiscence techniques) for the     promotion of wellbeing of hospitalized adult cancer patients. Participants are randomly     assigned to 2 conditions: intervention condition and control condition.   "
13883|NCT03103724|"     Open label, single arm, phase II multicentre study designed to determine the clinical     benefit, as measured by 3-months disease control rate (DCR) provided by enzalutamide in     metastatic Castration Resistant Prostate Cancer patients with at least one visceral site     involvement.   "
15823|NCT03078374|"     The purpose of this study is to obtain single-center safety and feasibility data on patients     managed with reduced anti-coagulation, and the incidence of thrombotic and bleeding adverse     events associated with the HeartMate 3 LVAS therapy.   "
13885|NCT03103698|"     The intraoperative assessment of analgesia remains problematic and no analgesia monitor is     used in routine practice. Currently, this assessment is based on hemodynamic changes,     although hypertension or tachycardia is neither sensitive nor specific. An overdose in     opioids exposes to many side effects ranging from respiratory depression to phenomena of     post-operative hyperalgesia. Conversely, an under-dosage in opioids is at the origin of a     nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative     morbidity or promote the occurrence of implicit memorization.      Nociceptive influx can not be detected directly. However, its ascent to the somesthetic area     of the cerebral cortex leads to physiological reactions that can be evaluated. In particular,     there are numerous anatomical and functional interactions between the autonomic nervous     system and the nociceptive tract in the brain stem. These interactions are mainly at the     level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the     solitary tract nucleus and the hypothalamus. The nociceptive influx thus leads to changes in     the activity of the ANS. The study of changes in the ANS would therefore be a method of     assessing the intensity of the nociceptive influx.      This objective method can be used in the non-communicating or unconscious patient to evaluate     the pain and to adapt the analgesic treatment to the best.      Obese patients who receive surgical management often have comorbidities such as restrictive     syndrome, or obstructive sleep apnea syndrome. They thus represent a target of choice in     perioperative analgesic optimization in order to avoid respiratory complications that may be     related to over or under assay of morphine such as atelectasis, alveolar hypoventilation.      It is hypothesized that this device is more effective for the intraoperative evaluation of     analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized     patients for bariatric surgery.   "
13886|NCT03103685|"     This is a prospective randomized open-label blinded endpoint (PROBE) The study will be     conducted in Maharaj Nakorn Chiang Mai hospital. The patients with dual-antipletlet who need     dental procedure between Febuary 2017 until Febuary 2018 will be included in the study.     Baseline characteristics of the enrolled patients including bleeding complication will be     collected in each patient. To compare rate of significant bleeding from dental procedure     between patient who need two antiplatelet and who stop P2Y12 inhibitors before procedure.   "
13887|NCT03103672|"     Percutaneous transhepatic cholangiography is a disturbing procedure for patients.      TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by     hemodynamic stability and better compilation profile The purpose of this study; To compare     total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous     transhepatic cholangiography under general anesthesia.   "
13888|NCT03103659|"     According to data from the French National Cancer Institute (INCA), almost one third of the     cancers were diagnosed in overs 75 years patients in France in 2008. The elderly patients     management is an important part in oncology daily practice.      These last years, through the geriatric oncology development, collaboration between     oncologists and geriatricians, the anti-cancer management and supportive care for elderly     patients has evolved. The assessement of potential fragility helps to determine the cancers     appropriate treatment plan.      Studies have shown that alterations in geriatric fields, found through Comprehensive     Geriatric Assessment (CGA) are associated with poorer survival, increased risk of     chemotherapy severe toxicity and autonomy loss.      Nursing home residents have often more frailties and functional problems than living at home     elderly resulting in diagnostic and therapeutic cancer delay. In addition, nursing home     residents must have appropriate treatment to preserve as much as possible their quality of     life.      Transversal Onco-Geriatrics Unit (UTOG), Day Hospital (HDJ), External Geriatric Mobile Unit     (EMGE) of the Internal Medicine, Geriatric and Therapeutic Department of the Marseille     hospital propose to organize a personalized care course for nursing home residents with     cancer to minimize the diagnostics delay, facilitate their management in oncology and     maintain their quality of life.      Elderly patient with suspected cancer is oriented by EMGE to HDJ to realize an oncological     and geriatric assessment. Patient would be supported by UTOG and would have access to     technical platform.      According to his cancer and nursing home location, the nearest reference center would be     offered.      Treatment or course of action (monitoring, palliative care …) would be decided in     onco-geriatric multidisciplinary meeting (RCP) (organized by Onco-Geriatric Coordination Unit     UCOG PACA west) and programmed and fast hospitalization would be organized in the reference     center.      When returning in nursing homes, elderly patient would be revalued by EMGE to continue     therapeutic management and personalized care plan. The aim of this management is to allow a     shorter hospitalization and maintain the quality of life of frailty patient during cancer     treatment.   "
13889|NCT03103646|"     This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor     itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.   "
13890|NCT03103633|"     Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational     study suggested that the cumulative duration of a triple-low state (intraoperative low MAP,     low BIS, and low Ce) was associated with poorer 30-day mortality.This randomized, prospective     study based on individualized Oxygen dynamics is designed to confirm this association.   "
13891|NCT03103620|"     A multi-center, prospective, consecutive enrolled, observational registry. The population     being studied includes all patients undergoing treatment of de novo lesions in native     coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF     coronary stent system. The registry will primarily assess the rate of MACE (cardiac death,     myocardial infarction and clinically driven target lesion revascularization.   "
13892|NCT03103607|"     There is a general belief among physicians involved with Graves' orbitopathy (GO) that this     syndrome is somehow chronic, namely that the patient's eyes do not return the way they were     before GO appeared.      The general impression that comes from the available studies is that the eyes of GO patients     do not return to normal even after a very long time since the disease appearance under the     physician's point of view, although a discrete proportion of patients feel so. However, no     studies are available in which the issue was examined with both objective criteria and     self-assessment.      The present study design was to investigated the disappearance of GO, regardless to     treatment, in all consecutive patients with a history of GO of at least 10 years who came for     a follow-up visit to our GO clinic over a period of 5 years.   "
13893|NCT03103594|"     The purpose of this research study is to evaluate the efficacy of intravesical botulinum A     toxin and DMSO in women with bladder pain syndrome who have not responded to first-line     treatments. Bladder pain syndrome is suprapubic pain with bladder filling as well as     frequency, urgency, and nocturia in the absence of urinary tract infection or other     pathology. DMSO has been shown to reduce pain in women with bladder pain syndrome as well as     increase bladder absorption of various drugs. Botulinum toxin A has also been shown to     improve pain in women with bladder pain syndrome when injected into the bladder suburothelium     via a cystoscope. The main objective of this study is to assess if DMSO can deliver botulinum     toxin to the suburothelium of the bladder to produce the same effect as direct injection of     Botulinum toxin and a better effect than DMSO alone.   "
13894|NCT03103581|"     The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel     preparation prior to colonoscopy in adult patients.   "
13895|NCT03103568|"     An open-label, non-randomized, 2-arm, 2-period fixed sequence phase 1 study to evaluate the     potential inhibition of nitisinone on cytochrome P450 2C9, 2D6, and 2E1 and the organic anion     transporters OAT1 and OAT3 in healthy volunteers   "
44932|NCT02697526|"     The aim of the study is to determine differences on radial artery occlusion from two     compressive methods used after transradial catheterization and its functional impact on hand     mobility.   "
13896|NCT03103555|"     This is pilot study aimed to investigate the application of proteosome inhibitor, Bortezomib     in treatment of patients with neutralizing autoantibody to IFN-γ. The investigators     hypothesis is that bortezomib will reduce the antibody level and restore interferon-gamma     function, resulting in clinical improvement and should be well-tolerated and safe for use in     patients with autoantibody to IFN-γ.   "
13898|NCT03103529|"     It has been suggested that activity immediately following concussion is detrimental to     recovery and may lead to long term impairments. The animal model has shown that exercise too     soon can lead to neurometabolic energy imbalances within the brain. However, there is also     evidence to suggest that prolonged inactivity has negative consequences that may contribute     to prolongation of symptoms. Determining the ideal timeframe in which to initiate an active     rehabilitation protocol for patients who are slow to recovery is an important factor in     concussion management.   "
13899|NCT03103516|"     To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural     decompression surgery on the recovery of spinal nerve function in patients with acute spinal     cord injury (complete and incomplete) at postoperative 6 months.   "
13900|NCT03103503|"     The purpose of this registry is to confirm the long-term safety and reliability of     BIOTRONIK's Plexa ICD lead.   "
13902|NCT03103477|"     The investigator's hypothesis is that smoking induces inflammation in the bladder wall. This     may predispose to the development of Interstitial cystitis(IC) / bladder pain syndrome(BPS).     Previous research has linked one the Platelet Activating Factor - PAF to interstitial     cystitis. The investigators will study a limited number of patients to determine whether PAF     is stable in urine and whether special precautions (for example - immediate freezing in     liquid nitrogen) is necessary for accurate measurement of PAF in the urine.      Patients who are presenting for an office visit will be asked to donate at least 50 ml of     urine.      A separate group of patients who are scheduled for surgery, are also being asked to donate     around 25 ml of urine during surgery.      No patient data other than group assignment, whether they smoke or if they have or not have     interstitial cystitis will be recorded.   "
13903|NCT03103464|"     Prior to discharging admitted patients, current UAB Hospital policy recommends physical     therapy intervention for patients with impaired functional mobility. However, UAB Hospital     currently does not have a standardized physical therapy protocol to rehabilitate admitted     patients with impaired functional mobility who require moderate assist (defined as physical     therapist expending 25-50% effort to assist the patient in standing). In order to reduce the     effect of impaired mobility, numerous interventions have been employed at UAB. As a result,     there is great variability of treatment procedures performed by various physical therapists     to help moderate assist patients return to their level of functioning prior to hospital     admission. The purpose of the study is three-fold: 1) to evaluate whether a proposed physical     therapy protocol using a commercially available medical device, the Movi chair, contributes     to improved mobility for moderate assist patients, 2) to investigate how patient rate of     rehabilitation to prior level of functioning is similar/different with the proposed physical     therapy protocol using Movi vs the current non-standardized practice for moderate assist     patients, and 3) to compare patient confidence in physical therapy with Movi vs the current     non-standardized practice using survey for moderate assist patients. In addition, we will     track participant's disposition i.e. continued motor and functional change following     discharge from the hospital through review of physical therapy records.   "
13904|NCT03103451|"     This is an open label, phase 1, 3+3, placebo-controlled dose escalating study of     tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single     subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa.     The study will enroll 28 healthy male volunteers.   "
13905|NCT03103438|"     This is an open label, phase 1, 3+3 dose escalating study of tolerability, safety,     pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of     the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will     enroll 19 healthy male volunteers.   "
13906|NCT03103425|"     The purpose of the study is to develop an emergency electroencephalogram (EEG) device,     StatNet, that can be placed quickly by minimally-trained personnel and interpreted remotely     for rapid identification of seizures.   "
13907|NCT03103412|"     This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of     single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with     UC. The relative bioavailability of tofacitinib released from TD-3504 compared to     co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.   "
13908|NCT03103399|"     The purpose of this study was to investigate the effect on the wearing-off phenomenon of 3     different doses of nebicapone (NEB 50 mg, 100 mg and 150 mg), compared with entacapone and     placebo when dministered concomitantly with existing treatment with levodopa plus a dopa     decarboxylase inhibitor (DDCI: carbidopa or benserazide).   "
13909|NCT03103386|"     The investigators hypothesize that long-term fermented high-fibre rye intake may reduce the     Helicobacter pylori infection through dampening inflammation and thereby leading to lower     adherence of the bacteria to surfaces.The investigators further hypothesize that that     inflammation could be a potential causal link between HP infection and insulin resistance, a     risk factor for type 2 diabetes and cardiovascular disease.   "
13910|NCT03103373|"     The study is a clinical trial, prospective and randomized of 60 patients of both genders,     aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare     plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy,     esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by     echocardiography or by conventional techniques (mean arterial pressure , Central venous     pressure).   "
21329|NCT03006380|"     Randomized controlled study to assess the efficacy and safety of the timing of administration     of prophylactic oxytocin via intramuscular route (before compared to after placental     delivery) on blood loss in vaginal delivery.   "
13911|NCT03103360|"     During routine general anesthesia (not standardized, left to the discretion of the attending     anesthesiologist), pupillary pain index was measured one minute before skin incision. Then,     variations in heart rate, blood pressure and bispectral index during the three minutes     following skin incision were recorded, as well as the occurrence of movements.   "
13912|NCT03103347|"     The investigators are studying the relationship between a certain oscillatory brain rhythm     (13-30 cycles/sec) that emerges prominently in patients with Parkinson's disease and symptoms     of slowness of movement. The investigators are recruiting patients with a range of severity     of Parkinson's disease symptoms to perform electroencephalography (EEG), in which the study     team records brain waves using electrodes placed on the scalp, while patients sit at rest or     perform certain hand tasks. The investigators will analyze the recorded brain waves to     extract the brain rhythm of interest and relate it to motor symptom severity as well as study     its behavior during rest and hand movement.   "
13913|NCT03103334|"     The objective is to determine whether the test product, Methotrexate 40 mg/mL solution for     injection administered subcutaneously by the prefilled and needle-free delivery system     Zeneo®, and the reference product, Methotrexate Biodim® 25 mg/mL, solution for injection     administered subcutaneously by a conventional syringe with needle are bioequivalent.   "
13914|NCT03103321|"     This randomized phase III trial studies how well decision aids work in improving knowledge in     patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge     of their condition and options for treatment, and may also help when talking with their     doctor.   "
13915|NCT03103308|"     This study will determine if a structured walking intervention will help maintain or improve     physical activity levels, physical function and quality of life in hematopoietic stem cell     transplant patients.   "
13916|NCT03103295|"     This study investigates safety and efficacy of traumatic bone defects treatment with use of     3D tissue engineered bone equivalent (3D-TEBE).      The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient     treatment for patients with traumatic long bone defects of critical size.   "
13917|NCT03103282|"     The objective of this post-market clinical follow-up study is to collect medical information     on patients implanted with PuraStat®, according to each participating institution's     procedures and standards of care.   "
13918|NCT03103269|"     The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile)     has more than tripled over the past 3 decades in the US. Overweight and physical inactivity     disproportionately affect low- income, female, African American adolescents.      A prior health-promotion/ obesity-prevention program for adolescents developed and tested by     our group (Challenge!) showed that adolescents who received the intervention were less likely     to become overweight or obese over 2 years when compared to the control group. This     intervention was administered one-on-one to adolescents in their homes or community by a     college-aged mentor.      Schools are an ideal setting for interventions because the effect can be far-reaching and     sustainable. School-based obesity-prevention interventions have thus far shown modest     results.      The purpose of this study is to evaluate the impact of a multilevel intervention that     includes both the Challenge program administered in a small group format after school using     mentors and teachers and a school-wide environmental change on adolescent females' body     composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade     female students. The small group intervention is conducted over 12 weeks and includes goal     setting focusing on healthy diet and physical activity, along with membership and weekly     trips to the YMCA. The environmental intervention includes a Health and Activity Committee     (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel,     parents, and community members. The HAC develops school-wide health promotion messages and     activities. Parents of participating 6th and 7th grade girls provide information on family     variables. The hypotheses are that females who receive the small group or environmental     intervention are at less risk of weight gain (overweight) than females in the control small     group condition, that females in environmental schools are at less risk of weight gain     (overweight) than females in the control environmental condition, and that females who     receive both the small group and environmental intervention are at the lower risk of weight     gain (overweight) than females who receive only the environmental or small group intervention     or neither intervention.   "
13919|NCT03103256|"     The purpose of this study is to determine superiority of YHP1701 comparing to each     monotherapy in patient with hypertension and primary hypercholesterolemia.   "
13921|NCT03103230|"     The purpose of this study is to study, among the aphasic person, if motor function ( studied     by Motor Evoked Potentials) performed within the first 14 days after a stroke can predict a     good recovery from aphasia 6 months of the initial episode.   "
13922|NCT03103217|"     Pregnancy is a time of significant adjustment and uncertainty. Anxiety is common among this     group and is associated with poor cognitive and physical outcomes for both the mother and     child. Few trials have been conducted to ascertain the effectiveness of brief psychological     interventions designed to alleviate general anxiety, labour and pregnancy specific anxiety     and promote well being.      The aim of this project is to establish if a brief Cognitive Behavioural Therapy treatment is     effective in reducing general anxiety during pregnancy. The study will also explore whether     the treatment has an impact on reducing pregnancy specific and labour related anxiety and     reducing medical intervention.   "
13923|NCT03103204|"     Obesity and gum diseases are highly prevalent in all parts of the world. Obesity can     negatively influence severity and progression rates of gum diseases. Presence of fat in the     body determines a general systemic state of inflammation. On the other hand, when gum     diseases are successfully treated systemic and local inflammation decrease. In addition     reductions in glycemic blood levels are also observed after treatment. Periodontitis is one     type of gum disease that is associated with bone loss. It could be treated within 24 hours by     using a protocol, which combines dental debridement and mouthwash. This treatment protocol,     named one-stage full-mouth disinfection works well in individuals of normal weight.     However, there is no information whether it is effective in obese individuals or not. Also,     it should be clarified if obesity influences response to periodontal treatment. This study     hypothesized that obesity impair response to periodontal treatment. Therefore, the effects of     the protocol one-stage full-mouth disinfection will be evaluated in obese individuals and     normal weight controls. This evaluation will be based on the monitoring of several clinical,     microbiological and biochemical parameters throughout 9 months. Participants will answer     validated questionnaires to evaluate if treatment of gum disease would be able to improve     individual's quality of life. Study population will be composed of 90 to 100 obese     individuals (males or females; > 18 years of age; smokers or non smokers; > 12 natural     teeth). Participants will be classified into 5 groups according to their body mass index in     normal weight (n = 15 to 20); overweight (n = 15 to 20); obesity I (n = 15 to 20); obesity II     (n = 15 to 20); obesity III (n = 15 to 20). Examinations will be performed before treatment     and also 3, 6 and 9 months after treatment. This study will contribute to the knowledge on     how obese individuals respond to this specific treatment protocol. Also, having normal weight     individuals as controls the present study will contribute to a better understanding about     obesity, in its different severities, influence on periodontal treatment.   "
14065|NCT03101358|"     This study evaluates a topical nanoparticle paclitaxel ointment (SOR007) for the treatment of     cutaneous metastases from non-melanoma cancer in adults. Three concentrations of SOR007 will     be evaluated in dose-rising cohorts of three. An expanded cohort will treat additional     subjects at the maximum tolerated dose.   "
13949|NCT03102866|"     This randomized pilot phase I/II trial studies how well aerobic and strength training     exercise works in improving fitness and arm health during and after radiation therapy in     patients with stage II-III breast cancer. Aerobic and strength training exercise training     during and after radiation therapy may reduce treatment related toxicities and improve     adherence to exercise long term in patients with breast cancer.   "
14205|NCT03099525|"     The objectives of this single center, prospective, non-interventional cohort is to understand     patient characteristics, general treatment patterns, effectiveness/safety of conventional     disease modifying antirheumatic drug (DMARD) and biologic DMARD treatments in rheumatoid     arthritis patients with ILD in the real-world setting   "
13924|NCT03103191|"     KL-6 may be a useful biomarker in patients with interstitial lung disease, but there is     limited information in non-Asian populations. Therefore, it is necessary to carry out studies     in other populations to confirm the diagnostic values of the biomarker and its prognostic     implication.      Hypothesis KL-6 may be a useful biomarker in the management of interstitial lung diseases.     But it is necessary to know more about its utility in the European population.      Study Objectives:        -  To determine the concentration of KL-6 in serum of patients with pulmonary fibrosis at          the time of diagnosis compared to patients without pulmonary fibrosis        -  Diagnostic yield of KL-6 in patients with pulmonary fibrosis.        -  Correlation of KL-6 values with functional and radiological parameters of disease          severity at diagnosis.        -  Correlation of serum KL-6 values with the evolution of the disease.   "
13925|NCT03103178|"     The purpose of the present study is to advance in the knowledge of quality of life in     patients with ILD by translating a ILD quality of life questionnaire.      There are no specific tools validated in Spanish to evaluate the quality of life in patients     with ILD, although these measures are useful for an comprensive evaluation of these patients.      Patients with ILD have a significant impact on their health. If we improve our Knowledge of     the different domains affected by the disease, and not only in the pathophysiological ones,     we will be able to develop tools to improve their management.   "
13926|NCT03103165|"     SimCoach, a computer program featuring a virtual human that speaks and gestures in a     videogame-like interface, is designed to encourage servicemembers to seek help to improve     their psychological health.   "
13927|NCT03103152|"     To demonstrate the acceptability and feasibility of recruitment to a randomised     chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or     Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate     cancer.   "
13928|NCT03103139|"     1. Biliary duct injury are a relatively frequent complication of hepatobiliary surgery,          most comonly laparoscopic cholecystecomy.        2. Prior to the development of more sophisticated endoscopic interventions, repeat surgery          was often necessary for the management of biliary leaks.        3. Advances in technique and technology in gastroenterology endoscopy have largely replaced          surgery as the first line intervention for biliary leak.        4. Most practices utilize endoscopic plastic biliary stent placement alone and are          efficacious and equivalent to the biliary stent placement with endoscopic biliary          sphincterotomy.        5. An area of variation is in whether biliary stent should cross the papilla ( with a          shorter stent) versus the site of the bile leak (with a longer stent).        6. Our objective is to assess whether placing a biliary stent across the leak versus across          the papilla alone improves the treatment of biliary leaks.   "
13929|NCT03103126|"     The study aims to investigate whether 12 weeks of structured aerobic and resistance exercises     completed at home can have a beneficial effect on the health of patients with type 2 diabetes     compared to standard physical activity advice. The study will investigate whether the     exercises can reduce factors such as patient's BMI, blood pressure and waist circumference,     as well as blood glucose and insulin sensitivity. Participants will use pedometers and     Therabands to carry out their exercises.      This will be compared to giving participants a physical activity advice sheet and no     structured exercise examples.   "
13930|NCT03103113|"     The purpose of this study was to assess the relationship between infertility blood test     results and outcomes of pregnancy and alive birth of women who underwent with or without     intravenous immunoglobulin (IVIG) before in vitro fertilization.   "
13931|NCT03103100|"     This study will compare and determine the most ideal local anesthetic (LA) solution to     activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus     lidocaine.   "
13932|NCT03103087|"     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once     daily co-administered with low dose estradiol and norethindrone acetate compared with placebo     for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this     study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed     by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and     norethindrone acetate compared with placebo for 24 weeks in the same population.   "
13933|NCT03103074|"     Randomized double blind placebo controlled pilot study/proof of concept-study to see if     intradermal injection with Botulinum toxin B is an effective treatment of Hidradenitis     suppurativa   "
13934|NCT03103061|"     The purpose of this study is to evaluate the feasibility, tolerability, safety, and image     quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected     ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Secondary aims     include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either     SPECT or invasive angiography.   "
13935|NCT03103048|"     This study will be featured as a randomized controlled. As the dependent variable, was     considered isometric grip manual force. As independent variable, the presence or absence of     forearm bandage in the fist flexor region of the volunteers.   "
13936|NCT03103035|"     The purpose of this study is to determine if a nutrition intervention provided through a     healthy eating blog is feasible and acceptable.   "
13946|NCT03102905|"     To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies     presenting an exanthema. This will make it possible to evaluate the prevalence of the     positivity of this PCR in the skin. Then the investigator can investigate whether there is an     association between the positivity of HHV6 PCR in the blood and / or skin and the viral     etiology of the exanthema. If this association exists, it will make it possible to improve     the diagnosis in the context of the exanthema and thus to improve the therapeutic management     of these patients.   "
13947|NCT03102892|"     The aim of this study is to evaluate adjuvant effect of antimicrobial photodynamic therapy in     periodontal treatment and salivary status of type 1 diabetes patients.   "
13948|NCT03102879|"     To compare the dental survival in a period of 2 years of mature permanent teeth with apical     lesion following the administration of encapsulated Mesenchymal Stem Cells under a     regenerative endodontic procedure and a conventional root canal treatment.   "
21330|NCT03006367|"     This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1     in Children and Adolescents (Ages 6-17 Years) with ADHD.   "
13937|NCT03103022|"     Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of     the heart that usually closes after birth but remains open in some premature infants born     before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause     problems such as bleeding in the lung and brain, lung injury due to prolonged need of     ventilator, and poor kidney function. It sometimes becomes necessary to close this blood     vessel in the preterm infant. Currently, this blood vessel can be closed either by medication     or surgery. Pain medications such as Ibuprofen and Indomethacin are routinely used     medications to close PDA. However, in the last 5 year, acetaminophen has been found as an     alternative medication to close PDA in preterm infants. In multiple studies, acetaminophen is     found to be a safe alternative medication with lower side effects than current standard     management. Intravenous Ibuprofen is approved by FDA to treat PDA in preterm infants.     Although not approved by FDA, oral ibuprofen is being used for the management of PDA.     However, the success rate of a single medication is approximately 70%. Both medications have     been used in the previous clinical studies to treat the same condition in the preterm infants     and fewer side effects were reported. Mechanism of both medications to close PDA is different     and may work more effectively together than single medication alone. In this study, the     investigator are going to use these two medications (Ibuprofen and Acetaminophen) at the same     time if the child needs treatment and is eligible to participate in this study. This study is     based on the assumption that by using both medications at the same time, investigator can     close this blood vessel more effectively than with either drug alone.   "
13938|NCT03103009|"     Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic     hypoglycemia (HH). The hypoglycemia is very debilitating and can be even life threatening.     There is limited experience with pasireotide in hyperinsulinemic hypoglycemia (only one     publication); there is more experience with octreotide, both in adults and children     successful interventions with octreotide in hyperinsulinemic hypoglycemia have been     published. Pasireotide via its different somatostatin receptor binding profile has clear     effects on insulin, glucagon and incretin secretion and can ultimately lead to hyperglycemia.     This mode of action (especially the effects on insulin and incretin secretion) could be very     useful in the setting of hyperinsulinemic hypoglycemia.   "
13939|NCT03102996|"     The aim of this study is to test if alkali treatment will preserve kidney graft function and     diminish the progression of chronic kidney disease in renal transplant patients. Additionally     the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in     this cohort.      This study is a multi-center, prospective, randomized, single-blind (patient),     placebo-controlled interventional trial to test the superiority of alkali treatment in     comparison to placebo on preservation of kidney function in 300 kidney transplant recipients.     The duration of the study will be 2 years for the individual participant. The patients will     be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product:     Nephrotrans®) and placebo arm (placebo comparator).      Several studies in CKD (chronic kidney disease) patients have shown that alkali therapy slows     progression of CKD.   "
13940|NCT03102983|"     The aim of our study is to show by fMRI the involvement of the motor system in the perception     of speech, and more particularly how this implication is modulated by the degree of     prototypicity of the stimuli.   "
13941|NCT03102970|"     The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 12% of the     adult population. This prevalence is expected to increase over the coming decades due to the     aging of the population and the continued exposure to risk factors for the disease. The     evolution of COPD is marked by the occurrence of exacerbations of varying severity and     patients are frequently admitted to the emergency department for evaluation, treatment and /     or hospitalization. Admission in emergency department for COPD exacerbation represents     approximately 1% of emergency admission.      Chronic pain is common in patients with Chronic Obstructive Pulmonary Disease (COPD). The     pain intensity may increase during acute episodes of exacerbations. This study is aimed to     compare pain intensity during exacerbation and stable phase of patients with chronic     obstructive pulmonary disease (COPD).   "
13942|NCT03102957|"     Exploring the reorganization (plasticity) of neuroanatomic networks associated with language     and memory in patients with left (or dominant hemisphere) temporal lobe epilepsy using     functional MRI (fMRI)   "
13943|NCT03102944|"     Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for     the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and     K2-EDTA plasma samples from healthy subjects.      K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy     volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system.     This will be a single-center study. The study will consist of a 1-day visit for each study     subject on which screening based on a questionnaire, blood draw and discharge will occur. For     each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and     K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily     at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health     status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from     eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for     Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be     measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after     blood collection. The data obtained will be used for determination of normal values of BNP in     a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and     stored at Philips for potential future analysis/ projects). Testing will be done according to     a DRAFT Instructions for use (IFU) of the Minicare BNP.   "
13944|NCT03102931|"     The overall objective of this clinical study is to determine if smokers who switch from their     usual high reactive oxygen and nitrous oxide species (ROS/NOS) products to a low ROS/NOS     product exhibit increased or decreased levels of oxidative stress/damage, respectively.   "
13945|NCT03102918|"     Investigators aim to determine Epidiolex's promise as a pharmacotherapy for cannabis use     disorder. Investigators hypothesize that Epidiolex, when added to medical management, will     result in greater reductions in marijuana use compared to placebo as measured by the 2     primary outcome measures: 1) quantitative THC levels and 2) self-report by Timeline Follow     Back. Secondary outcome measures will include treatment retention, patient satisfaction,     cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, , compliance,     and cigarette use.   "
13950|NCT03102853|"     This project will examine whether long-term consumption of healthy Nordic foods can maintain     a healthy weight also after weight loss, and decrease abdominal fat accumulation and     cardiometabolic risk. The study will be performed with the aim to achieve a substantial body     weight loss in the first phase by prescribing a standardized low caloric dietary formula. The     follow-up phase will be a body weight-maintenance period and the subjects will be randomised     to a healthy Nordic diet group and a control diet group. During the study body weight will be     monitored and other measurements will include insulin sensitivity, blood lipids and     inflammation markers.   "
13951|NCT03102840|"     Streptococcus pneumoniae is a type of bacteria that is carried (lives) in the nose of most     individuals and can sometimes go on to cause severe infections such as meningitis and     pneumonia. There are over 100 types of pneumococcus, and children in the UK have been     routinely immunized against pneumococcal disease since 2006. A vaccine against 13 types of     pneumococcus (PCV 13) was introduced into the UK in 2010, replacing a previous version that     prevented 7 types.      Pneumococcal carriage in the Thames Valley region has been studied over the last 7 years with     carriage rates having been shown to be reflective of potential severe pneumococcal disease     and hence vaccine effect.      The main purpose of this study is to see whether the pneumococcal immunization program has     changed the frequency and nature of pneumococcal bacteria carried by children, as this may     give a clue as to what changes in pneumococcal disease are likely to be seen in the future.     In addition, this study is especially timely given the possibility of a change in the PCV 13     immunization schedule that is currently being assessed in the 'Sched3' Immunization study     (NCT02482636). Obtaining accurate baseline data will be important in informing the     interpretation of any subsequent data on carriage rates obtained following introduction of     the new schedule.      This study will enroll approximately 1600 children aged 13 to 48 months living in the Thames     Valley and South Midlands and which have had three doses of 13-valent pneumococcal conjugate     vaccine. The study consists of one visit done at a convenient venue (GP surgeries,     educational/ play settings, or home) where a single nasal swab and an optional finger-prick     blood sample for a sub-set of 632 participants, will be performed. No additional follow-up is     needed. The study recruitment period will be done over 12 months.   "
13952|NCT03102827|"     To demonstrate the effectiveness and safety of nocturnal ventilation with oxygen (HFT -     high-flow-therapy) for the treatment of CSA in patients with HFrEF compared to placebo     (patient will breathe ambient air via nasal cannula that is not connected to the     high-flow-device).   "
13953|NCT03102814|"     The main aim of this multi-centre stepped wedge randomized controlled trial is to improve the     quality, professional practice and cost-effective utilization of health care resources by     evaluating if a new rehabilitation program aimed at bridging gaps in rehabilitation across     levels of care may increase and/or prolong the effect of rehabilitation.   "
13954|NCT03102801|"     Glucose is a sugar carried in the blood stream that body uses for energy. If someone has     diabetes, blood glucose level can be erratic, sometimes becoming very low this is called     Hypoglycaemia (or a hypo), and can happen when blood glucose levels drop below 4 mmol/l.      So far in order to prove that a hypo happened for a patient, blood glucose level can only be     measured at time of the hypo and not after it.      In this study we are trying to identify certain chemical substances (biomarkers) in diabetic     patients that may be measured in blood tests of the patient up to after 24 hours of the hypo     and if we could prove that a hypo has happened we could adjust tablets and or insulin dosage     in a way to prevent further hypos.      The study will be conducted in the Diabetes Centre in Hull Royal Infirmary and will involve     three visits to the diabetes centre. The study can finish in a week time after the first     visit.      Visit 1 is the screening visit to identify eligibility to take part in the study. Visit 2     insulin infusion will be given to make participants blood sugar level fall lower than normal     for a short time and corrected quickly afterward. This is a stress for participant's body and     should stimulate certain chemicals that we are trying to identify during hypo.      In Visit 3, the main purpose of this visit which is done 24 hours after insulin infusion is     to take a blood sample and check how participants is after visit 2.      We will recruit 25 Type 2 Diabetic patients and 25 none diabetics to compare both results.      Both groups should not have ischemic heart disease, underactive thyroid or seizures and on     stable dosage of medications.   "
13955|NCT03102788|"     The main aim in this randomized controlled trial is to improve access to safe and effective     care, professional practice and cost-effective utilisation of health care resources by     testing if occupational therapist-led care is as effective and safe as rheumatologist-led     care for people with hand osteoarthritis.   "
13956|NCT03102775|"     In a cluster-randomized design, the study evaluates the effectiveness of a skill- training     program for social work professionals with the aim of improving the follow-up of low income     families within Norwegian labor and welfare services. While the Norwegian Labor and Welfare     Administration are responsible for developing and implementing the program, researchers at     Oslo and Akershus University College are conducting an independent evaluation of its     effectiveness. By close follow up and better coordination of existing services the model aims     to improve the financial and housing situation of the family, labor market attachment among     the parents and the social inclusion of children. The cluster-randomized field experiment     will take place over a 40-month period, involving 29 labor and welfare offices, 58 family     coordinators and, based on estimations, 650 families. The research is funded by the Norwegian     Labor and Welfare Administration.      The project is financed by Labour and Welfare Administration and led by Ira     Malmberg-Heimonen, Faculty of Social Sciences. Participants in the project are: Ira     Malmberg-Heimonen (project leader), Anne Grete Tøge, Krisztina Gyüre, Knut Fossestøl,     Marianne Rugkåsa, Berit Bergheim and Tone Liodden.   "
13957|NCT03102762|"     To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an     alternative line of treatment in patients with erectile dysfunction - not responding to oral     PDE5i - through cavernosal smooth muscle relaxation.   "
13978|NCT03102489|"     Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy     Volunteers.   "
14066|NCT03101345|"     The objective of this research project is to determine the impact on brain HEP metabolites     and fluxes of an oral consumption of a commercially available nutrition product (Peptamen®     1.5 vanilla) in healthy volunteers.      Therefore, we intend to perform 31P-MRS before and after oral intake of the nutrition     product.   "
14033|NCT03101774|"     Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT     device in different operation principle in COPD are so far lacking. Therefore the     investigators perform an adequately powered RCT on the effects of two IMT device application     as an pulmonary physical therapy in patients with COPD with inspiratory muscle weakness.   "
48393|NCT02652182|"     The aim of this study is to investigate whether or not short-term expose to air pollution is     associated with in-hospital outcomes, such as mortality and morbidity.   "
13958|NCT03102749|"     New insights of small airway contribution to asthma have been gained. Poor levels of control     and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with     predominant small airway involvement. Very few pathological specificities were identified at     this site: mast cells infiltration was suggested as the specific inflammatory change when     compared to the proximal airways.Biomarkers in asthma are still complex to validate,     especially in the blood, since compartmentalisation is intense in the lung and the airways, a     property attributed to the filtering role of the lung to maintain homeostasis. Over the last     few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect     reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts     were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to     airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been     shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS,     sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the     management of the disease, identify areas of therapeutic resistance and constitute a     therapeutic guidance tool. In this study, investigators aimed to assess small airway     involvement in asthmatic women as far as they could. For this purpose, investigators analysed     trends in air trapping by acquiring expiratory CT slices at each dose during a     bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted     to clinical and demographical characteristics in their ability to predict the small airway     involvement index obtained at CT.   "
13959|NCT03102736|"     The purpose of this study is to test the effects of the medication ketamine and the     medication called nitroprusside in patients with major depression. Ketamine has both good and     bad effects. Some studies have shown that ketamine improves depression. However, studies have     also shown that it causes strange and sometimes unpleasant sensations referred to psychotic     or dissociative symptoms. An example of a psychotic symptom would be hearing or seeing     something that in reality is not there. The study team would like to see if nitroprusside can     prevent the reported bad effects of ketamine without blocking the reported good effects. This     might make ketamine a better treatment for depression.   "
13960|NCT03102723|"     There remains a clinical need to improve health outcomes in patients with ischemic heart     disease (IHD) the leading cause of death and disability in Singapore and worldwide. One     neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation     myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention     (PPCI). This results in microvascular obstruction (MVO) and cardiomyocyte death and     contributes upto 50% of the final myocardial infarct (MI) size. Cangrelor, a potent     intravenous platelet P2Y12 inhibitor with rapid onset and offset of action, has been     demonstrated in experimental animal studies to reduce MI size when administered prior to     reperfusion. Whether Cangrelor given together with Ticagrelor would be more effective at     reducing MI size in STEMI patients treated by PPCI is not known and is investigated in the     Platelet Inhibition to Target Reperfusion Injury (PITRI) trial.   "
13961|NCT03102710|"     The aim of this study is to use a brain stimulation tool called transcranial direct current     stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of     lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin     cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily     influence the way the stimulated part of the brain functions. With this method, the     involvement of specific parts of the brain can be investigated in the working of the brain as     a whole.   "
13962|NCT03102697|"     This is a cohort study with the objective of describing during a 12-month follow-up, weight     loss in obese patients submitted to treatment using two consecutively air-filled IGB     (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the     first and the placement of the second.   "
13963|NCT03102684|"     Limited studies have evaluated potential exposure to secondhand e-cigarette aerosol, an     indication of impact on indoor air quality. Also limited are the studies regarding direct     passive exposure of humans and most of these studies have limitations, such as the small     number of participants, the different methodology and devices used, or the fact that they are     laboratory studies, where exposure parameters differ significantly from the actual user's     habit and device. Therefore, TackSHS Project has foreseen an intervention study of cross-over     design in similar to real-life conditions that aims to assess the mediating effect of     e-cigarette battery output on pulmonary outcomes and indexes to provide a better     understanding of the extent to which passive exposure to aerosols produced by use of     e-cigarette impacts exhaled NO and exhaled breath condensate metabolites.   "
13964|NCT03102671|"     The recurrence of major cardiac events after infarction is very high, in some populations up     to 20% in the first year. Optimal secondary prevention as organized in cardiac rehabilitation     centers is effective in reducing both morbidity and mortality. However, many studies have     shown that the participation and adherence rate in CR-programs is low in most European     countries. Therefore, novel ways of delivering secondary prevention using information     technology and self-monitoring are being explored. Hence, this study will investigate the     effectiveness of a mobile, patient tailored, app based multidisciplinary telerehabilitation     program (HeartHab app) in improving exercise capacity, lifestyle and risk factors in patients     with coronary artery disease in a post-rehabilitation setting.   "
13965|NCT03102658|"     Because micafungin is generally well tolerated and appears to have limited interaction with     other drugs, it is a potential important agent in the treatment of invasive fungal     infections. Although micafungin is approved for the treatment of invasive candidiasis, dosing     guidelines for micafungin in (morbidly) obese patients are not available. Subsequently, the     pharmacokinetic profile of micafungin (as well as other echinocandins) in this specific     patient population is still largely unknown.      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic     gastric bypass surgery will receive a single dose of 100 mg or 200mg micafungin (besides     standard anti-bacterial prophylaxis) and samples for a pharmacokinetic curve will be taken.     These PK-values can then be compared to the PK in a normal-weight group which will receive     100mg micafungin   "
14428|NCT03096600|"     Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis     associated to liberation have good functional results and doesn't present much complication     cases.      So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of     surgery can be associated to fast track surgery.   "
13966|NCT03102645|"     A double-blinded, randomized, crossover study in healthy females with placebo and single dose     imipramine 50 mg.      Primary objective: Does imipramine increase the tone of the external urethral sphincter?     Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP     increases correlate with effect in treating stress urinary incontinence. Can imipramine treat     stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the     anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The     investigators also wish to establish the within-subject standard deviation for AAR to enable     power calculations in future studies.   "
13967|NCT03102632|"     Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and     effective long-term treatment regimen. Unfortunately, there are still no disease-specific     treatment for ADPKD approved in the US. A rational step towards identifying such agents is to     test therapies that have a proven safety profile with mechanisms of action that can counter     the disease progression.      The purpose of this study is to investigate whether drinking increased amounts of water     (water loading) might slow down polycystic kidney growth or kidney function decline. Water     loading can cause the suppression of a pathway that causes fluid buildup and cyst growth.     High water intake has been safely used in the clinical setting, such as in the case of kidney     stone therapy. New York State tap water is widely available and safe, making it highly     cost-effective as well.   "
13968|NCT03102619|"     Postoperative observation of patients is based on the Early Warning Score (EWS). By using     continuous wireless monitoring of vital parameters it may be possible to predict the risk of     complications after abdominal cancer surgery. The object of this pilot study is to test the     equipment and methods for the next phases. Patients will be monitored for 4 days     postoperatively and data is analyzed retrospectively. Vital parameters are monitored with     ECG, blood pressure monitor and pulseoximetry.      In the analysis the investigators will compare the results from the continuous monitoring to     the measurements made by the nurses and registered in the EWS. The primary outcomes for the     pilot study are the frequency of measurements resulting in a single parameter score of 3     according to the EWS algorithm.   "
13969|NCT03102606|"     To assess Duration of Severe Neutropenia (DSN) in treatment Cycle 1 in patients with advanced     or metastatic breast cancer, who have failed >/= 1 but < 5 prior lines of chemotherapy;     advanced or metastatic non-small cell lung cancer (NSCLC) after failing platinum based     therapy; or hormone refractory (androgen independent) metastatic prostate cancer treated with     docetaxel (75 mg/m2) + plinabulin (RP3D) versus docetaxel (75 mg/m2) + pegfilgrastim (6 mg).     Neutrophils count will be assessed at baseline; Pre dose during Cycle 1, Day 1, 2, 5, 6, 7,     8, 9, 10, 15.   "
13970|NCT03102593|"     The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics     of ARGX-113 in Patients with Primary Immune Thrombocytopenia.   "
13971|NCT03102580|"     Knee and hip osteoarthritis (OA) is the most common cause of disability in the U.S. and     affects more than 60% of adults over 65 years. As the burden of knee and hip OA increases     among aging adults, more patients are deciding to have joint replacement surgery. However, no     clear guidelines exist for patients to determine if or when to undergo total joint     replacement (TJR).      The investigators plan to develop a web-based system that will provide individualized patient     OA Care Plans that will help patients make informed decisions about how to treat their     arthritis. The investigators will be using this system with patients to see if they find it     useful.      The investigators believe that the OA Care plan will improve the process and quality of OA     treatment decisions and the quality of OA care.   "
13972|NCT03102567|"     This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to     evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of     GLPG1205 in healthy male subjects.      The study will comprise of 2 parts, a first part to investigate the effect of aging and a     second part to investigate the effect of a loading dose.   "
13973|NCT03102554|"     This study seeks to identify genetic causes of conditions that affect the gonads and     genitals, and to study the impact on families of receiving genetic results.   "
13974|NCT03102541|"     Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac     surgery (CS), and represents one of the most significant negative predictors of patient     outcome in this population. In the healthy adult, a high protein meal is known to enhance     glomerular filtration rate and is mediated by an increase in renal blood flow. The     investigators hypothesized that preoperative oral protein load may precondition the kidneys     for upcoming insults.   "
13975|NCT03102528|"     Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac     surgery (CS), and represents one of the most significant negative predictors of patient     outcome in this population. The investigators sought to examine the prevalence of AKI, renal     recovery and development of de-novo chronic kidney disease in all patients undergoing cardiac     surgery at San Bortolo Hospital, Italy 2014-2015.   "
13976|NCT03102515|"     Analgesia following surgery associates different intra-venous or oral analgesic drugs and     sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be     administered as a complement. In the specific context of caesarean sections, pain control is     mandatory to enable the mother to take care of her offspring and shorten their hospital stay.     This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural),     enabling the injection of morphine in the subdural or epidural space, as part of a multimodal     analgesia regimen.      Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided     (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce     postoperative morphine consumption. Recent studies have compared the two techniques and found     conflicting results. Furthermore, they did not consider caesarean section performed under     epidural analgesia, with a different neuraxial injection site, neither did they compared pain     after postoperative day 2.      Consequently, the aim of this study was to compare resting and standing pain up to     postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia     and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous     infiltration provided a better analgesia at day 2.   "
13977|NCT03102502|"     The present study aimed to investigated the effect of Enhanced External Counterpulsation     (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related     mechanisms   "
13979|NCT03102476|"     Type 1 Diabetes mellitus (T1D) is characterized by βcell destruction and a long life     requirement of exogenous insulin. The bolus basal insulin regimen is a widely accepted     therapy concept to treat hyperglycaemia in patients with T1D. This concept requires a very     good knowledge of the individuals prandial and basal insulin requirements. However, insulin     requirement depends on insulin absorption from the injection site and the individual's     insulin sensitivity which relies on a number of effects including body composition,     inflammatory processes and environmental factors. Climatic factors such as differences in air     temperature could affect both, insulin absorption and insulin sensitivity as suggested by     recent reports. For instance, it is reported that hot baths can accelerate the absorption of     short acting but not of long acting insulin formulations from the subcutaneous depot. In     addition, local warming of the injection site by a novel device (InsuPatch) results as well     in an accelerated insulin action profile of short acting insulins. Moreover, Berglund et al.     reported seasonal variations in insulin sensitivity in elderly men with increased insulin     sensitivity during summer time.      Although an effect of temperature on insulin absorption and action can be assumed and was     subject to current clinical trials, there is only little knowledge on the effect of humidity     and the cumulative effect of humidity and temperature on insulin pharmacodynamics and     pharmacokinetics. For subjects with type 2 diabetes it was reported that accommodation to     high temperatures and moist air of more than 75% is impaired compared to healthy subjects as     determined by skin blood flow, temperature and moisture. Although it can be estimated that     changes in blood flow due to hot and moist air affect the pharmacokinetics and     pharmacodynamics of subcutaneous prandial insulins, to our knowledge no such study in     subjects with T1D using the euglycaemic clamp technique was carried out yet. In order to     assess the effect of temperature and humidity on insulin action, subjects with type 1     diabetes will be administered a single dose of short acting insulin in an environmental     chamber either at 15°C or a warm environment of 40°C with either a low or high humidity (10%     vs. 90%). Moreover, an exploratory part of the trial will evaluate the measurement     performance of several blood glucose meters under the experimental climatic situations.   "
13980|NCT03102463|"     This study aims to ascertain the potential of novel milk derived hydrolysates to improve     glycaemic control to promote metabolic health. A comprehensive characterisation of the     metabolic response to these milk derived hydrolysates will ascertain the effect of the     hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve     insulin resistance in cell and animal models. Therefore the investigators aim is to test     their efficacy in overweight, insulin resistant individuals at risk of developing type 2     diabetes.   "
13981|NCT03102450|"     In spite of many advantages of spermicides, there is no contraceptive efficacy study     conducted with any spermicide in women aged over 40 years. That is why the aim of this study     is to evaluate contraceptive efficacy, tolerance and acceptability of a spermicide with     benzalkonium chloride (Pharmatex® cream) in women aged over 40 years.   "
13983|NCT03102424|"     The primary study objective is to demonstrate the use of Dragon Waves Resonant Home Care     Electronic Nerve Stimulator (DW1330) is associated with improvement of blood glucose control,     as measured by change of glycated hemoglobin (HbA1c). The second study objectives are to     demonstrate that DW1330 is associated with the mechanism of glycemic control and inflammation     pathways. The study is also aimed to investigate the safety of DW1330.   "
13984|NCT03102411|"     This cross-sectional survey study is to determine the prevalence of functional     gastrointestinal (GI) disorders in the general population and to describe common triggers for     food-related GI symptoms.   "
13985|NCT03102398|"     The purpose of this phase I/IIa study is to assess the safety and tolerability profile of     TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted     via a single-arm and open-label fashion.   "
13986|NCT03102385|"     This study examines the effects of a web-based motivational interview on 1) internal     motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation     intention and behavior. The study also evaluates whether group differences in donation     intention and behavior are mediated by autonomy, competence, and relatedness, and in turn,     internal motivation.   "
13987|NCT03102372|"     In this study, we aimed to examine the effect of whey protein supplementation given before     night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet     (VLCD).      Half of the participants underwent a 4 week VLCD and walking program, while the other half     underwent a 4 week VLCD, walking program and had an additional protein supplement before each     night sleep.   "
13988|NCT03102359|"     The investigators investigated in the present study whether selective head cooling and     dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has     cerebral protective effect in patients undergoing liver transplantation.   "
13989|NCT03102346|"     Home-based CR (HBCR) was reported to improve the clinical outcomes of coronary artery disease     (CAD) patients. There is no data published to investigate whether HBCR is also effective for     Chinese CAD patients who have been revascularized.      This trial was designed to investigate the safety and efficacy of CR program at home for     Chinese patients who underwent PCI (Percutaneous Coronary Intervention) procedure. This is a     multicenter, randomized, controlled and observational study.   "
13990|NCT03102333|"     In the case of the newlys developed PCA, the infusion rate is increased according to the     patient's need for bolus button, so that the pain can be controlled more efficiently.   "
13991|NCT03102320|"     The key purpose of the main part of the study is to assess efficacy and safety of anetumab     ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid     tumors.      The main purpose of the safety lead-in (dose-finding) part of the study is to determine the     safety and tolerability of anetumab ravtansine in combination with cisplatin and in     combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination     with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with     gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.      Patients will receive anetumab ravtansine every three weeks in monotherapy for most     indications. In cholangiocarcinoma and adenocarinoma of the pancreas, 3-weekly anetumab     ravtansine is administered in combination with cisplatin or gemcitabine respectively (both     administered in a 2 week on / 1 week off schedule).      Treatment will continue until disease progression or until another criterion for withdrawal     is met. .Efficacy will be measured by evaluating the tumor's objective response rate.     Radiological tumor assessments will be performed at defined time points until the patient's     disease progresses.      Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival     or fresh biopsy tissue may also be collected for review and biomarkers.   "
14280|NCT03098537|"     Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill     patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding     prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any     acid suppressing drugs while other half receives it. They will be followed for     gastrointestinal bleeding.   "
13992|NCT03102307|"     A downstaging of axillary tumor-spread can be achieved in about 40% of the patients receiving     neoadjuvant chemotherapy (NACT). The impact of NACT on loco-regional tumor control has not     yet been sufficiently investigated. Moreover the pathologic nodal status after NACT is a     strong prognostic marker. Therefore it is most desirable to identify the approximately 40% of     patients with pathologic complete response of the axilla, that could be spared from a     potentially non beneficial axillary lymph node dissection (ALND). Attempts to identify these     patients via sentinel lymph node biopsy (SLNB) after NACT have failed to provide acceptable     false negative rates (FNR). The new concept of targeted axillary dissection (TAD) following     NACT has shown promising results. Still multiple information about the clinical adoption of     this procedure into clinical practice are missing. The SenTa registry trial is designed to     assess the clinical implementation of TAD into general practice.   "
13993|NCT03102294|"     Inspiratory muscle training for 8 weeks in patients with chronic thromboembolic pulmonary     hypertension.   "
13994|NCT03102281|"     Bile duct stones is a common biliary tract disease, which is characterized by high morbidity     and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an     effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which     associated with recurrent cholangiolithiasis often carried out on difficult intubation or     extracting stones, probably due to enhanced reflux of intestinal contents that changes the     microenvironment. Patients with cholangiolithiasis were consecutively recruited and their     bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S     ribosomal RNA gene was performed to characterize the microbiota in the bile and other body     fluids. A liquid chromatography mass spectrometry-based method was used to profile bile     composition. Clinical manifestation, microbiome, and bile composition were compared between     patients with or without recurrent of bile duct stones. The aim of our study was to identify     the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.   "
13995|NCT03102268|"     Exosomes are part of extracellular vesicles(EVs), and can be secreted into the environment by     many types of cells. It has been demonstrated that the content and function of exosomes     depends on the originating cell and the conditions under which they are produced.Exosomes     contain proteins,RNAs and lipid,which may transfer biological information and activities from     donor cells to receptor cells. Non-coding RNAs are involved in many biological activities     including tumor growth and metastasis.      In this prospective translational study, preclinical and clinical phases have been designed.     On the first step, the main goal is to characterize the ncRNAs of cholangiocarcinoma derived     exosomes. This exosome biomarker may provide a useful diagnostic tool. As a second step, the     study will evaluate the prognostic and predictive value of cholangiocarcinoma exosomes levels     in plasma in a prospectively recruited cohort of cholangiocarcinoma patients before and after     surgical resection.   "
13996|NCT03102255|"     The goal of this prospective randomized study is to compare the effect of nasal tip lifting     during nasotracheal intubation.      The question the investigators are trying to answer is: If the nasal tip is tilted, will the     E-tube be more likely to enter the lower passage during nasal intubation?   "
13997|NCT03102242|"     Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable     stage IIIA and IIIB NSCLC eligible for chemoradiotherapy with curative intent.   "
13998|NCT03102229|"     This study will aim to demonstrate that implementation of a rapid, multidisciplinary     supportive care program for patients receiving chemoradiotherapy who are deemed to be at high     risk for hospitalization based on real-time pedometer data will reduce the rate of     hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.   "
13999|NCT03102216|"     The 2015 Abbott Point-of-Care Great Minds Summit in Berlin presented novel research that     showed the potential for upfront, point-of-care (POC) blood testing to improve waiting times,     costs and patient flow in the Emergency Department (ED). POC testing has become a focus area     for enquiry as EDs worldwide look for ways to cope with over-crowding and reduce waiting     times.      In South African EDs, the target time for patients to be seen is dictated by their triage     category. Patients triaged Red (critical) should ideally be seen immediately, Orange within     10 minutes, Yellow within 1 hour and Green within 4 hours of arrival. Whilst patients may     initially be evaluated within the above time frames, there may be delays in their final     disposition due to time lags in obtaining results from special tests and/or investigations.     Traditionally, blood tests and other special investigations such as electrocardiograms (ECG)     and radiological investigations (x-rays) take place after the doctor has evaluated the     patient. Patients (and doctors) then have to wait for the results of these tests before a     decision can be made regarding the patient's final disposition.      Instead of sending blood specimens to the laboratory for analysis, POC blood testing refers     to selected tests which can be performed in the ED and provide immediate on-site results and     thus have the potential to expedite patient management decisions. Similarly, low dose x-ray     (LODOX®) is the radiological equivalent of a POC blood test providing a full body x-ray     within 19 seconds. LODOX has been evaluated in trauma patients previously but its application     as a screening tool for non-trauma patients in the ED has not been properly explored thus     far. Electrocardiograms (ECGs) are commonly used in clinical medicine as a POC test to     evaluate the heart. Locally, Helen Joseph Hospital ED in Johannesburg has a constant influx     of critically ill and injured patients 24 hours a day. The aim of this     investigator-initiated, prospective, randomised control trial is to compare and assess the     standard workflow pathway currently in use in the ED to a modified pathway that makes use of     upfront, early POC tests (blood tests, ECG and/or LODOX) to see if the use of such has any     significant effect on costs, waiting times and associated patient flow patterns in the ED.   "
14000|NCT03102203|"     To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in     evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the     establishment of new diagnostic criteria for the identification of true and pseudoprogression     of high-grade gliomas.   "
14001|NCT03102190|"     Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce     inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is     characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial     of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this     study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP.   "
14002|NCT03102177|"     This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic     study using stable isotope carbon-13 labeled levothyroxine   "
14088|NCT03101059|"     Mounier-Kuhn syndrome (MKS), or congenital tracheobronchiomegaly, is an entity characterized     by dilation of the trachea and bronchi, associated with respiratory infections.The main signs     and symptoms are cough, bulging and purulent expectoration, digital clubbing, dyspnoea, and     wheezing.Some of these symptoms are believed to be due to excessive collapse of the     intra-thoracic trachea and bronchi, resulting in airways obstruction of more than 50% . The     purpose of this study is to identify and reduce tracheal collapse.   "
14003|NCT03102164|"     The study will include 30 consecutive patients with acute heart failure (AHF). In 20 patients     the investigators will perform cardiologic rehabilitation. In the remaining 10 patients only     standard pharmacotherapy will be administered. The cardiologic rehabilitation will follow the     protocol used routinely in patients with AHF admitted to the Centre for Heart     Disease,Military Hospital in Wroclaw. This protocol includes gradually increasing level of     physical exercise (e.g.: respiratory exercises, assisted, active dynamic, and relaxation     exercises, as well as short-term isometric exercises and general exercises of very low     intensity, short duration and properly adjusted recovery phase).      The following tests will be conducted on the first and last day of hospitalization and 30     days following the discharge:      clinical evaluation (medical interview, routine physical examination, echocardiography,     assessment of natriuretic peptides (NT-proBNP), basic laboratory tests with special emphasis     on the inflammatory markers and renal and liver parameters); hemodynamic evaluation (i.e.     non-invasive evaluation of cardiac output and systemic vascular resistance using of impedance     cardiography); evaluation of biomarkers reflecting myocyte-damage (i.e. immunochemical     measures of tissue-specific enzymatic isoforms, enabling to distinguish the markers of     skeletal muscle damage vs. markers of myocardial injury - e.g. creatine kinase CK, its     muscular isozyme CKMM, lactate dehydrogenase 5 LDH5, myoglobin, and carbonic anhydrase III,     determined using test based on ELISA). On the first day of hospitalization, as well as on the     first, third and last day of rehabilitation (the latter term corresponding to the last day of     hospitalization as well) and also 30 days after the discharge, the following tests will be     performed (both times: at rest and post-exercise): hemodynamic evaluation, the evaluation of     skeletal muscle function (using surface electromyography (sEMG); maximum tonus of the muscles     will be determined along with the level of muscular fatigability and its changes over time;     the evaluation of muscle tissue perfusion (assessed on the basis of oxygenation level, with     non-invasive, direct continuous recording of the perfusion in peripheral tissues by local     tissue oximetry, measured by the near-infrared spectroscopy (NIRS). NIRS is based on the     absorption of near-infrared waves by oxygenated and reduced haemoglobin. The levels of     absorption reflect the degree of tissue oxygenation in a given area of microcirculation.     Furthermore, a capillary gasometry (oxygen saturation and lactate concentration) will be     determined). Moreover, two functional tests will be performed at the discharge and 30 days     after the discharge: the 6-minute walk test and the 30-second chair stand test examining     the strength endurance of the lower extremities (pertaining to repeated getting up from a     chair over a period of 30 seconds).   "
14004|NCT03102151|"     The study examines the possible effect of a community campaign to decrease the duration of     untreated psychosis in persons with their first episode of a psychotic disorder.   "
14005|NCT03102138|"     This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a     further 4 years with regular visits to assess safety.   "
14006|NCT03102125|"     The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount     of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft     dysfunction in contrast to those with normal graft function. The investigators hypothesize     that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial     perfusion reserve, related to microvascular allograft vasculopathy, compared to those with     normal graft function.   "
14007|NCT03102112|"     Malignant gliomas are the most common and deadly primary brain tumors in adults. The clinical     outcome of patients with glioblastoma depends on key molecular genetic alteration.     Specifically, Isocitrate Dehydrogenase Gene Mutation, an independent favorable prognostic     factor, serve as diagnostic and prognostic markers of glioma. Thus, accurate grading of a     glioma is fundamental in order to determine the treatment strategy. Amide proton transfer     (APT) imaging is a noninvasive molecular MRI technique based on chemical exchange saturation     transfer mechanism that detects endogenous mobile proteins and peptides in biological     tissues. Preliminary studies have shown that APT-weighted (APTw) signal intensity could serve     as a new imaging biomarker, by revealing significantly higher signal intensities in the     high-grade gliomas compared with the low-grade gliomas. The purpose of this study was to     investigate the value of amide proton transfer imaging (APT) in the noninvasive evaluation of     isocitrate dehydrogenase (IDH) gene status in glioma.   "
14008|NCT03102099|"     To evaluate the application value of contrast-enhanced ultrasound in the diagnosis of thyroid     nodules using fine needle aspiration.   "
14009|NCT03102086|"     Dental calculus is a calcified deposits firmly attached to teeth and implants surfaces.     Dental calculus is strongly associated with periodontitis and considered to have indirect     role in the pathogenesis of periodontal diseases. Dental calculus composed primarily of     calcium phosphate mineral salts originated in the saliva covered by unmineralized bacterial     layer. Composition of calculus varies from person to person and influenced by numerous     variables such as: age, gender systemic disease and ethnic background.      Nephrolithiasis (kidney stones) are composed of insoluble salts of constituents of the     forming urine. The most two frequent stone types are: Calcium oxalate (with a frequency of     15% -35%) and Calcium phosphate (5% -20%). The prevalence of kidney stones varies with race,     sex, and geographic location. In the United States for men, kidney stone rates vary between     4%-9%, and for women, kidney stone rates range between 2%-4%.      Previous studies dealt with the connection between sialolithiasis and nephrolithiasis were     inconclusive. To the authors' best knowledge no studies were done to examine the associations     between nephrolithiasis and dental calculus. Thus, the aim of this study is to compare the     mineral composition of both dental calculus and nephrolithiasis and determine whether     nephrolithiasis composition may be linked to the periodontal status.   "
14010|NCT03102073|"     Interventional, parallel groups, single center trial with a prospective design   "
14011|NCT03102060|"     This pilot clinical trial studies how well a gluten free diet works in preventing graft     versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes     the transplanted cells from a donor can make an immune response against the body's normal     cells (called graft versus host disease). A gluten free diet may decrease intestinal     inflammation and graft versus host disease in patients who are undergoing a donor stem cell     transplant.   "
14012|NCT03102047|"     This study is being done to look at the safety and response to the investigational drug     durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV     rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and     triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment     will be completed just before the course of durvalumab is initiated.      In order to learn more about certain characteristics of rectal cancer tumors, this study     includes special research tests using samples from diagnostic tumors, a tissue sample from     tumors removed during surgery, fresh tumor samples from an area where the cancer has     recurred, and blood samples.   "
14013|NCT03102034|"     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in     RSV-seronegative infants and children 6 to 24 months of age.      This study is a companion study to CIR 313.   "
14014|NCT03102021|"     The purpose of this study is to determine if the use of erythropoietin when used in high dose     during acute kidney injury can decrease the number of days of kidney injury.   "
14015|NCT03102008|"     The purpose of this protocol is to employ single case analytic strategies, including a     multiple baseline design and novel modeling techniques to identify changes in cross-cutting     features of emotional disorders as well as emotional disorder symptoms during the     implementation of The Unified Protocol for the Treatment of Emotional Disorders in     Adolescents (UP-A). The first aim is to investigate relationships between the use of UP-A     treatment components and changes in measures of cross-cutting features of emotional     disorders. The second aim is to investigate when and how reductions in symptoms of emotional     disorders and presenting problems (i.e., symptoms of anxiety and depression, severity of     presenting problems) occur throughout treatment.   "
14016|NCT03101995|"     From the global burden of Cervical Cancer (CC), 85% occurs in developing countries,     representing 12% of cancer in women. In Mexico CC ranks second in incidence and mortality     among women. The National Institute of Cancer in Mexico (lNCAN) receives annually about 500     patients with CC, 80% of which are diagnosed with locally advanced disease. Furthermore, 10     to 20% of these present kidney deterioration. The main reason for kidney disease is ureteral     obstruction, other causes include age and comorbidities, such as diabetes and hypertension.     The standard treatment for locally advanced disease consists in concomitant     chemo-radiotherapy based on cisplatin (QT-RT), followed by brachytherapy, with an absolute     benefit of 10%. However, the use of cisplatin in patients with renal disease may be     questionable, considering it is a nephrotoxic treatment. Given that renal dysfunction limits     the standard treatment efficiency because of the widely known nephrotoxicity of cisplatin, in     most Cancer Centers of our country, patients with renal dysfunction receive only radiation     therapy, even though it has proven less effective than concomitant QT-RT, limiting     disease-free and overall survival of these patients. Venook et al. used gemcitabine as a     radiosensitizer in patients with cancer and renal dysfunction. Our group, has observed     encouraging results using gemcitabine as an alternative to cisplatin in concomitant treatment     with radiotherapy, in CC patients with renal insufficiency. 89% of patients had complete     response and improvement in renal function, with an enhanced creatinine clearance after     treatment. Therefore, it is necessary to explore the safety of gemcitabine as an alternative     treatment for CC patients with locally advanced disease and renal deterioration. We propose     this clinical trial to assess the safety of treatment with gemcitabine and specifically on     renal function in patients with renal deterioration. It is important to take into     consideration that CC in advanced stages produces pain, transvaginal fetid discharge and     general discomfort. It also causes side effects secondary to renal failure such as nausea,     vomiting, fatigue, anemia, among others. These effects have a significant impact on the     quality of life of these patients. Cancer treatment and its side effects, besides the     implications of a nephrostomy catheter or ileostomy bag, determine the deterioration in the     quality of life of the patient, during and sometimes after treatment. Thus it is of utmost     importance to evaluate the factors that could help improve the quality of life of patients     and explore the factors that deteriorate it. This clinical trial aims to generate scientific     evidence to help make the best decisions concerning the treatment of patients with cervical     cancer and renal impairment, and the impact on their quality of life.   "
14018|NCT03101969|"     Patients tend to miss their scheduled appointments in chronic pain clinics for unknown     reasons. This study will test the hypothesis in a prospective pragmatic trial that a human     telephone call in the primary language of the patient, promising a clinical encounter in this     language improves attendance at scheduled appointments in an academic inner city pain clinic.   "
14019|NCT03101956|"     The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate     the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free     deep squat range of motion in order to answer several conceptual and practical research     questions   "
14020|NCT03101943|"     This study aims to assess the impact of a brief home-visiting module, called Family Spirit     Nurture (FSN), on American Indian (AI) parent feeding practices associated with increased     risk for early childhood obesity, with a primary focus on delaying introduction of infants'     Sugar Sweetened Beverage (SSB) (including soda, energy drinks, juice with added sugar and     other drinks with added sugar) intake while teaching mothers complementary feeding and     responsive parenting practices. The investigators will also assess how water insecurity may     moderate parents' feeding of SSBs to young children. Finally, the investigators will explore     whether maternal knowledge of oral health practices and/or reduction of infants' SSB intake     influences early indicators of infant's oral health (i.e., infants' oral microbiome and     plaque formation). Our evaluation will employ a randomized controlled design, in which the     control condition receives a beneficial home-safety educational model and assistance in     safety proofing their homes for small children. Assessments in both groups will occur at     baseline (between 6 and 10 weeks postpartum) and 4 months, 6 months, 9 months and 12 months     postpartum.      Primary Aims:      Aim 1: To determine the effectiveness of the brief (6 lessons) FSN home-visiting parent     feeding practice module on reducing SSB initiation and frequency among infants between 3 and     12 months of age. Hypothesis 1: Infants whose mothers receive FSN vs. controls will be less     likely to introduce SSBs between 3 and 12 months of age.      Aim 2: To determine the effectiveness of FSN to promote optimal complementary feeding and     responsive parenting practices. Hypothesis 2: Mothers who receive FSN vs. controls will be     more likely to practice recommended complementary feeding and responsive parenting practices     between 3 and 12 months of age.      Aim 3: To determine the impact of water insecurity on SSB consumption among infants between 3     and 6 months of age. Hypothesis 2: Parents who report water insecurity vs. those who do not     will be more likely to give infants SSBs between 3 and 6 months of age.      Secondary Aims:      Secondary Aim 1: To explore if provision of water to families reduces SSB intake among     mothers and infants ages 6 to 9 months of age.      Secondary Aim 2: To explore if infants in the FSN intervention have better oral health     outcomes than control infants up to 12 months postpartum.   "
14021|NCT03101930|"     This project tests the principle hypothesis that stable glucagon like peptide-1 (GLP-1)     analogues have specific GLP1R-dependent beneficial effects on vascular endothelial function,     fibrinolysis and inflammation in obesity that exceed the benefits of weight loss, and that     genetic or other individual factors that modulate GLP1R sensitivity can modify the effect of     these analogues on cardiovascular risk.   "
14049|NCT03101566|"     The purpose of this trial is to evaluate the effect of investigational drug nivolumab in     combination with either gemcitabine/cisplatin chemotherapy, or in combination with another     investigational agent ipilimumab in patients with advanced unresectable biliary tract cancer.      Gemcitabine/cisplatin is the standard of care treatment for biliary tract cancer.      Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the     body's own immune system to attack the cancer cells. Nivolumab (Opdivo) is FDA approved for     the treatment of several cancers including metastatic melanoma, advanced lung, kidney, head &     neck and bladder cancer. The combination of nivolumab and ipilimumab (Yervoy) is FDA approved     for metastatic melanoma.   "
45147|NCT02694757|"     The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing     readmission rates of subjects with new ileostomies in the first 30 days post-operatively.   "
14023|NCT03101904|"     The study will aim to describe and evaluate the effect of chronic beetroot juice     supplementation on acute mountain sickness symptoms and exercise in a hypoxic environment. It     is hypothesized that beetroot supplementation will decrease acute mountain sickness and     increase exercise performance.   "
14024|NCT03101891|"     This study offers eligible pregnant patients with a fetal diagnosis of congenital bilateral     renal agenesis (CoBRA) serial amnioinfusions with normal saline. All eligible patients will     be offered intervention but may also elect expectant management.   "
14025|NCT03101878|"     The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of     IONIS AGT-LRx in Healthy Volunteers and Hypertensive Patients with Blood Pressure Controlled     on ACE Inhibitors or ARBs   "
14034|NCT03101761|"     Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic     papules, evolving by painful relapse due to cold and sudden reheating.      This pathology is currently poorly understood while it's frequent.      The aim of the study is to evaluate all the characteristics of this pathology by reporting     clinical and biological data of patient consulting for chilblains; and the other point is to     assess the evolution of these patients.   "
14026|NCT03101865|"     The suggested clinical trial is part of the KidsAP project funded by the European     Commission's Horizon 2020 Framework Programme. The project evaluates the use of the     Artificial Pancreas (or closed loop systems) in very young children with type 1 diabetes     (T1D) aged 1 to 7 years. The suggested trial is a feasibility study to pilot the setup of a     large-scale outcome trial and to address the specific needs of this population. The results     of the pilot trial will feed into the design of the outcome study.      In this study the investigators will compare closed loop insulin delivery using standard     strength insulin to closed loop use with diluted insulin in very young children with T1D.     Diluted insulin is a standard treatment approach for children with low insulin requirements.     The investigators hypothesize that diluted insulin will lead to more stable glucose levels by     reducing inaccuracies accentuated by delivery of minute amounts of insulin (frequently less     than 0.1U/h [1μl/h with standard strength insulin] in small children compared to 1U/h in     adults). These inaccuracies may result from pump plunger micro-jumps, tissues pressure     build-up, and infusion set kinking. This study builds on previous and on-going studies of     closed loop systems that have been performed in Cambridge in children and adolescents with     T1D in clinical research facilities and in the home setting.      The study adopts an open-label, multi-centre, multinational, randomised, two-period crossover     design contrasting closed loop glucose control using diluted insulin and closed loop using     standard insulin strength under free-living home conditions. The two intervention periods     will last 3 weeks each with a 1 to 4 weeks washout period in between. The order of the two     interventions will be random. A total of up to 30 young children aged 1 to 7 years with T1D     on insulin pump therapy will be recruited through outpatient diabetes clinics at     participating clinical centres to allow for 24 completed subjects available for assessment in     each of the study arms.      Prior to the use of study devices, participants and parents/guardians will receive     appropriate training by the research team on the safe use of the study pump and continuous     glucose monitoring system, and the hybrid closed loop insulin delivery system. Carers at     nursery or school may also receive training by the study team if required. During the     intervention periods, subjects and parents/guardians will use the closed loop system for 21     days under free-living conditions in their home and nursery/school environment without remote     monitoring or supervision by research staff.      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/l as recorded by     CGM. Secondary outcomes are the time spent with glucose levels above and below target, as     recorded by CGM, and other CGM-based metrics. Safety evaluation comprises the tabulation of     severe hypoglycaemic episodes.   "
14027|NCT03101852|"     Severe (SAM, Body Mass Index-z < -3) and moderate (MAM, -3 ≤ BMI-z < -2) acute malnutrition,     highly prevalent in HIV-infected children and adolescents, is an independent risk factor of     death, even when antiretroviral treatment (ART) is initiated. The objectives of the SNAC'S     study are to assess acceptability and effectiveness of outpatient nutritional rehabilitation,     using ready-to-use food (RUF), elaborated in compliance with national and international     recommendations and implemented in HIV-infected children and adolescents, under active     follow-up in the 12 main pediatric HIV care sites in Senegal and presenting with SAM or MAM.   "
14029|NCT03101826|"     The Polyvagal Theory focuses on how function and structure changed in the vertebrate     autonomic nervous system during evolution. The theory is named for the vagus, a major cranial     nerve that regulates bodily state. As a function of evolution, humans and other mammals have     a new vagal pathway that links the regulation of bodily state to the control of the muscles     of the face and head including the middle ear muscles. These pathways regulating body state,     facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively     function as a Social Engagement System (SES). Because the Social Engagement System is an     integrated system, interventions influencing one component of this system (e.g., middle ear     muscles) may impact on the other components.      Individuals with Prader-Willi Syndrome (PWS) exhibit many behaviors that are consistent with     a compromised Social Engagement System. Atypical function of the Social Engagement System     results in problems associated with state regulation (e.g., impulsivity, tantrums, and     difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth,     hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory     processing and hypersensitivity, and socialization. We propose to confirm that several     features of the behavioral phenotype of PWS may be explained within the context of a     dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention     designed as a 'neural exercise' of the SES (Specific Aim II).      Specific Aims:      Aim I: To demonstrate that children with PWS have atypical regulation of the SES. We     hypothesize these effects will be manifested by dampened vagal regulation of the heart (low     parasympathetic tone); poor middle ear muscle regulation resulting in auditory     hypersensitivities and poor auditory processing; lack of voice intonation (prosody), and     difficulties in accurately detecting the emotions of others.      Aim II: To demonstrate the effectiveness of the Listening Project Protocol (LPP) in     decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that     individuals who complete the LPP will have improved vagal regulation of the heart, improved     middle ear muscle regulation, increased voice intonation and improved ability to accurately     detect the emotions of others.   "
14064|NCT03101371|"     Urinary Tract Infection (UTI) complications following catheter use in surgical patients     remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by     50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use     associated with this complication and improve cost-effectiveness of care. The investigators     hypothesize that they can reduce the incidence of UTIs after catheter placement with the     implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the     environment exposure of the catheter before, during and after insertion.   "
14030|NCT03101813|"     Doctors and other medical scientists want learn about the biology of DIPG and to develop     better ways to diagnose and treat patients with DIPG. To do this, they need more information     about the characteristics of DIPG tumors. Therefore, they want to establish a central     location for clinical information and tumor tissue collected from DIPG patients.      The purposes of this study are:        -  To enroll patients diagnosed with DIPG in the International DIPG Registry and          Repository.        -  To provide a central location for clinical information, scans, and tissue samples from          patients with DIPG enrolled in the registry.        -  To collect tissue samples in order to study how DIPG works on the molecular level.          Researchers may use the tissue samples to study molecules such as proteins and DNA.          Proteins are needed for the body to function properly and DNA is the molecule that          carries our genetic information. Other researchers will be able to use the stored          samples in the future to learn more about DIPG. The information researchers get from the          research studies will be kept in the registry along with the clinical information.        -  To help DIPG investigators around the world to work together to make more consistent          diagnosis and better design of future research studies. We hope this will lead to better          treatments for DIPG in the future.   "
14031|NCT03101800|"     Azathioprine is considered first line immunomodulatory therapy for patients with ulcerative     colitis. Up to 50% are treatment failures or experience adverse events leading to treatment     withdrawal. Recent evidence suggests that the combination of allopurinol and low dose     azathioprine increases the proportion of treatment responders and reduce the risk of adverse     events.      Objectives: To evaluate the beneficial and harmful effects of low dose azathioprine and     allopurinol versus standard azathioprine monotherapy in patients with ulcerative colitis.   "
14032|NCT03101787|"     Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted     defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained     return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized     controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in     patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular     fibrillation or tachycardia. It aims to determine the effect on survival and neurological     outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.   "
49641|NCT02635880|"     To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM     laser that offers multiple wavelengths for removal of benign pigmented lesions.   "
14035|NCT03101748|"     The goal of this clinical research study is to learn if adding neratinib to either taxol     (paclitaxel) or to the combination of pertuzumab, trastuzumab, and paclitaxel can help to     control metastatic or locally advanced breast cancer when given before other standard     chemotherapy (doxorubicin and/or cyclophosphamide) and surgery. Researchers also want to find     the highest tolerable dose of neratinib that can be used in these study drug combinations.     The safety of these drug combinations will also be studied.   "
14036|NCT03101735|"     This is a non interventional, multicenter clinical trial, in adult patients receiving     Tecfidera per approved SmPC and routine clinical practice. The primary objective of this     study is to evaluate the total societal costs to the healthcare system related to the use of     Tecfidera in RRMS patients. The study will capture data in a simple matter that can be easily     interpreted providing an advantage in a country where efforts in the market access arena are     in their infancy. For the aforementioned reasons, the proposed study may prove quite valuable     in supporting DMF as a cost‐effective therapy, valuable not only for patients but for the     public health care system as well, providing all the necessary information for the evaluation     that need to be examined regarding the positive reimbursement list and future decisions.   "
14037|NCT03101722|"     To investigate the effects of hearing aid, huperzine A and combination of hearing aid and     huperzine A on tinnitus suppression, hearing and cognitive function protection in patients     with presbycusis   "
14038|NCT03101709|"     This is a clinical study to observe the safety and feasibility of chimeric antigen receptor     19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.   "
14039|NCT03101696|"     The gold standard to induce coronary hyperemia for measurement of fractional flow reserve     (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) is     adenosine, but it exerts several side effects due to its unspecific action on adenosine     receptors. The specific A2a-receptor agonist, regadenoson, has been shown to dilate coronary     arteries and enables FFR measurements. The aim of the study was to evaluate whether     simultaneous measurement of FFR, CFR and IMR is feasible, safe and effective within     regadenoson-induced hyperemia.   "
14050|NCT03101553|"     The present study aims to examine the feasibility of a computerized treatment for social     anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have     developed in reducing evaluation and social threat biases, they will conduct a two-arm     randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50)     will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each     condition will consist of eight 25 minute treatment sessions. Participants will complete two     sessions per week for four weeks and will be administered assessments at pre-treatment, one     week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to     greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to     greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to     greater reductions in threat interpretations and greater increases in benign interpretations     than the PMR condition; 4) The effects of condition on social anxiety symptoms will be     mediated by changes in social anxiety-related interpretation bias; and 5) The effects of     condition will be maintained at the 3-month follow-up assessment.   "
14040|NCT03101683|"     STUDY DESCRIPTION: This is a single-arm study to assess the feasibility, toxicity and     cosmetic outcome of partial radiotherapy of the chest wall in breast cancer patients at     increased risk of local relapse submitted to nipple-areola complex (NAC) sparing mastectomy     and immediate implant-based reconstruction Inclusion criteria      Histologically confirmed diagnosis of in situ ductal carcinoma (pTis) or invasive breast     carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast     reconstruction (expander or prosthesis) and:      Group A)      Negative sentinel node dissection or axillary clearance (pN0) and all the following risk     factors:      Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast     quadrant Tumor diameter >2 cm Age ≤50 years Group B)      Positive sentinel dissection (pN1a) followed by axillary clearance (or primary axillary     clearance) with only 1 positive node and any of the following risk factors:      Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast     quadrant Age ≤50 years Tumor diameter >2 cm Grade 3 histology Lymphovascular invasion HER-2     overexpression/amplification Triple negativity Treatment - Radioterapy The tumor bed is     defined by the area at risk (skin and the pectoralis muscles) delineated by surgical clips     and 3D-MRI reconstruction for a precise localization of the tumor excised. The clinical     target volume (CTV) is defined as the tumor bed with a 1.5 cm margin limited by skin contour.      A dose of 40 Gy is delivered in 16 fractions (2.5 Gy per fraction). For conventional     post-mastectomy radiotherapy this moderately hypofractionated schedule is considered feasible     and safe (31). Even more so, this schedule should be feasible and safe for a smaller     irradiated volume as in the current protocol. Regional nodal irradiation is not considered at     our Institution for patients fulfilling the entry criteria of the protocol.      OUTCOME MEASURES Primary To assess feasibility of PCWRT via VMAT-IGRT linac-based or helical     Tomotherapy To assess the safety of PCWRT via VMAT-IGRT linac-based or helical Tomotherapy To     assess the surgical complication of implant-based breast reconstruction after PCWRT Secondary     To assess the cosmetic outcome of implant-based breast reconstruction after PCWRT To assess     patients' satisfaction of implant-based breast reconstruction after PCWRT   "
14041|NCT03101670|"     This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with     moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or     are intolerant to conventional disease-modifying therapy. A total of approximately 124     subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib     tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days     before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized     to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period     lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study     for a maximum of 24 weeks (from Screening visit to Follow-up visit).   "
14042|NCT03101657|"     The increase in psychological violence in our society, but also and above all the search for     the best possible reparation for this violence, leads increasingly to questioning the     evaluation of psychotraumatisms. In practice, there is no consensus as to the method of     assessing psychological repercussions and determining ITI. This topic concerns any physician   "
14043|NCT03101644|"     This study will assess and characterize the variability observed in the response to darunavir     therapy, an antiretroviral medication used against the Human Immunodeficiency Virus (HIV).     More specifically, it aims to quantify variations in the drug's blood concentrations and     determine the sources of such variability, both genetic and non-genetic. In light of this     information, current dosage guidelines will then be reviewed.   "
14054|NCT03101501|"     The clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the     improvement of near vision in presbyopic patients treated with low dose Mitomycin C     immediately following femtosecond flap creation.   "
14055|NCT03101488|"     The study is to evaluate and characterize the tolerability and safety profile of single agent     KN035 in Chinese adult subjects with unresectable advanced carcinoma.   "
14044|NCT03101631|"     The Comprehensive Geriatric Assessment (CGA) is, still today, barely established in the     standard practice. Although the different scientific societies recommend a CGA in elderly     population affected with cancer at first visit, the evidence regarding its transcendence is     limited. On the other hand, the components of this evaluation and the translation of their     findings in changes in the clinical practice are not stablished. This project intends to     implement a CGA in a group of patients to compare this group with an historical cohort that     reflects the standard practice, to evaluate the differences between both approaches. The     study also evaluate the feasibility and utility of this CGA. All these questions aims to     support the hypothesis that CGA impacts on the cancer treatment for elderly population     affected with cancer.   "
14045|NCT03101618|"     We investigated the prevalence of animal allergy and sensitization to animal allergen among     participants in international symposium of Korean association for laboratory science     (laboratory animal researchers) and companion animal exhibition (pet owner and pet-related     industry workers).   "
14046|NCT03101605|"     An e-learning module to teach how to evaluate ears in children was recently designed. The aim     of this study is to measure the impact of this e-learning module on the trainees' ability to     appropriately diagnose ear infection in clinical setting.   "
14047|NCT03101592|"     This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies     for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression,     and cost compared to the standard of care. The study will be conducted in Malawi and Zambia     among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART.     Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART     scripting (varies by country, region, clinic, and/or provider), (2) three-month ART     scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in     Malawi and 15 in Zambia, and will be randomized to a study arm.   "
14048|NCT03101579|"     It has been proved that intrathecal chemotherapy is the main treatment strategy for     leptomeningeal metastases. At present, the commonly used drugs for intrathecal chemotherapy     include methotrexate, cytarabine, and liposomal cytarabine. In recent decades, no new     effective drugs have been discovered for intrathecal chemotherapy. The recurrence of     leptomeningeal metastases is inevitable even after aggressive treatment. There is no     effective treatment for recurrent leptomeningeal metastases after comprehensive treatment     which includes intrathecal methotrexate and/or cytarabine, central nervous system radiation     therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs. The quality of     life is extremely poor, and the patients always die in short time. Pemetrexed is a newer     multitargeted antifolate which has shown activity in various tumors. It has higher     effectiveness and safety, which has been used as the first-line treatment of non-small cell     lung cancer. In animal studies, pemetrexed was demonstrated to suppress tumor growth     completely in mice with two types of transplanted human colon xenografts resistant to     methotrexate. Therefore, the purpose of the study is to evaluate the safety and feasibility     of intrathecal pemetrexed in patients with recurrent leptomeningeal metastases from non-small     cell lung cancer.   "
14063|NCT03101384|"     Diagnostic errors have been reported frequently in patient with pulmonary embolism since     symptoms are not specific. However, there is only scarce evidence that the delay associated     with diagnostic errors may impact patient prognosis. The aim of this study is to determine     the frequency of diagnostic errors and if they are associated with more severe pulmonary     embolism in term of initial presentation and complications.   "
26059|NCT02944604|"     The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients     with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil     reduction.   "
14051|NCT03101540|"     For a number of reasons women with major depressive disorder often discontinue conventional     antidepressants when they become pregnant and prefer not to take them when depressive illness     develops in the course of pregnancy. There is now considerable evidence that the     administration of the omega-3 polyunsaturated fatty acid, eicosapentaenoic acid (EPA), as     monotherapy has antidepressant effects. If it could be clearly established as effective such     an approach would offer a valuable alternative for woman who are at risk for, or who develop,     depressive disorder during pregnancy. Strongly positive placebo-controlled trials of EPA     supplementation, though, co-exist with entirely negative ones. No clear reasons for these     discrepancies have emerged but one possibility is that the samples studied have differed in     the proportion of individuals likely to benefit from EPA supplementation. As there has been     no effort to identify such individuals we propose to explore two groups of measures, both     relevant to EPA's likely mechanisms of action, as potential tools for identifying individuals     likely to benefit this treatment. Hypothesis: Among women who experience major depressive     episodes during their first two trimesters of pregnancy, baseline measures of cytokine     activity and erythrocyte PUFA concentrations will be associated, in an additive or     interactive fashion, with subsequent improvement in depressive symptoms among women taking     omega-3 PUFA supplementation.   "
14052|NCT03101527|"     The purpose of this study is to determine if omega-3 polyunsaturated fatty acids as a     monotherapy have antidepressant effects during pregnancy. It will also provide pilot data     pertaining to relationships between apparent response to omega-3 monotherapy and both plasma     cytokine and erythrocyte essential fatty acid concentrations.   "
14053|NCT03101514|"     About 89%-100% patients with head and neck malignant tumors have radiation mucositis during     their radiotherapy. Until now, there is no effective method to prevent mucositis. Steroid     hormone, pain-relief, anti-inflammatory and other symptom-relief treatments usually are used     after the emergence of mucositis. Coixenol triglyceride is an ester extract of Coix Seed. Its     trade name is Kanglaite Injection, which has been approved in China and Russia. Kanglaite has     anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite could also improve the     quality of life of patients and mitigate the condition of the cachexia. In china, two studies     evaluating treatment of Kanglaite to nasopharyngeal cancer, found that Kanglaite can reduce     radiotherapy mucositis. So far, Kanglaite on the prevention and treatment of radiation     mucositis of the head and neck malignant tumor is still lack of strong clinical trial     evidence. This is a phase II, single center, one arm study with subject to evaluate the acute     radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of     head and neck cancer.   "
14056|NCT03101475|"     This is a single-arm, open-label, multi-center early phase II study. This proof of concept     study will investigate whether the combined use of local tumor ablation/radiation plus     immunomodulating drugs may induce a significant immune response in patient with incurable     liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable     or in partial remission after completion of 4-6 months first line systemic therapy.      The primary objective of the study is to show an overall response rate of lesions not treated     by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria)     higher than 10%. With the continuation of first line systemic treatment, no further responses     are expected.      Secondary objectives are:        -  To establish the feasibility and safety of the combined treatment modalities;        -  To study the impact of the local technique (RFA/Radiotherapy) on the results;        -  To investigate biomarkers to predict response to the combined treatment   "
14057|NCT03101462|"     This randomized, open-label, single-site study at Saint Louis University will enroll     approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in     a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season     appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season     appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20     will receive TIV.   "
14058|NCT03101449|"     This research aims to evaluate the effects of vocal conditioning through two semioccluded     vocal tract exercises (SOVTE) in choir singers.   "
14059|NCT03101436|"     In this study, the investigators will evaluate the prebiotic effect of a moderate intake of     extra virgin olive oil or red wine on the modulation of gut microbiota composition and the     improvement of cardiometabolic factors in obese and lean adults subjects.   "
14060|NCT03101423|"     Hematopoietic stem cell transplantation is currently the only way to cure thalassemia, one of     its main obstacles is the rejection after transplantation, chimerism continued to decline,     which eventually lead to transplant failure. chimerism is a key indicator of the succession     of immune response, which is a key indicator for predicting the failure of hematopoietic stem     cell transplantation and provides an important basis for early detection of rejection.     Transplantation of continuous chimerism can detect early unstable chimeras and rejection.The     chimerism rates after transplantation were continuously monitored using fluorescence labeled     multiplex PCR amplification of short tandem repeats (STR-PCR)      ,and then follow our STR different rates for early interventional therapy to prevent further     reduction in chimerism leading to lead to graft failure.   "
14061|NCT03101410|"     This clinical project aims to study the relationship between gluten consumption and its     impact on digestive comfort, quality of life and performance of non-celiac athletes     practicing an intensive physical activity..   "
14062|NCT03101397|"     Diffuse Parenchymal Lung Disease(DPLD) is a chronic progressive fibrosis lung disease that     with a highly variable clinical process.Krebs von den Lungen-6 (KL-6) is a     high-molecular-weight glycoprotein, classified as human MUC1 mucin, that is produced mainly     by regenerating type II pneumocytes.Serum levels of KL-6 have been shown to be elevated in     patients with DPLD and could predict progress, but unaware of the differential threshold. The     objective of this study was to perspectively and sequentially monitor serum KL-6 levels in     patients with different DPLD,then analyze its clinical value and find the differential     threshold.   "
14067|NCT03101332|"     Panic disorder with agoraphobia (PDA) is associated with considerable personal distress,     functional disability and societal costs. A large number of studies have shown that Cognitive     Behavior Therapy (CBT) is a highly effective treatment for PDA. However, the CBT-protocols     proven to be most effective involves repeated exposure to the particular environments the     agoraphobic patient fears such as trains, tunnels, lifts and shops. This cause great     practical problems for health care services as such therapeutic efforts involves spending     considerable time outside the clinic. For primary care services this is particularly     challenging due to the large number of patients expected to be seen. Normally clinicians meet     up to 7 patients daily which makes it almost practically impossible to offer 2-hour sessions,     which is necessary to carry out the relevant exposure tasks. Hence, the treatment proven to     be most effective, which primary care services are commissioned to deliver, is too     comprehensive and time consuming to be applied in real practice.      The investigators believe that a possible solution to the above problem is to provide     evidence-based CBT but with the exposure components carried out through Virtual Reality (VR)     rather than in vivo. Some research has already been done with virtual reality and exposure     therapy for anxiety disorders with promising results. The aim of this pilot study is to treat     patients with agoraphobia with or with a history of panic disorder with a standardized     exposure-based CBT-protocol through VR. The virtual environments that are used for the study     are live sequences filmed in 360°. The investigators hypothesize that CBT with VR will be     effective and lead to improvements on measures of panic disorder and agoraphobia.   "
14068|NCT03101319|"     The treatment of schizophrenia is challenging as the existing medications improve only the     positive symptoms with the limited benefit on cognitive and negative symptoms which have a     large bearing on the functional outcome. Recent research has suggested the association of low     level of vitamin D with schizophrenia but studies are few and marred by mixed results. Thus,     we propose to evaluate the effect of weekly vitamin D3 supplementation in patients with     first-episode schizophrenia through a randomised doubled blind placebo controlled     design.Fifty-six participants of either sex (19 - 50 years) with schizophrenia having vitamin     D insufficiency/deficiency (< 30 ng/ml) will be randomly supplemented with Vitamin D3 or     placebo for 8 weeks in 1:1 pattern. The clinical treatment i.e., antipsychotic medications     will be continued as usual within the two groups. Participants in both the groups will be     assessed at study entry, at the end of the 04 and 08 weeks (after completing supplementation)     on the Positive and Negative Syndrome Scale (PANSS), Computerized Neurocognitive Battery     (CNB) & Clinical Global Improvement (CGI) subscale (CGI-I). Raters will be blind to the group     assigned to participants. Side effects will be monitored at every visit.The serum levels of     vitamin D will be measured at baseline and at the end of 08 weeks.   "
14115|NCT03100695|"     A prospective, randomised study is to investigate the feasibility of conducting a superiority     randomised controlled trial comparing the application of combined autologous PRP and     concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed     intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh     tibial diaphyseal fractures.   "
14069|NCT03101306|"     The standard treatment for locally advanced cervical cancer is concurrent chemo-radiotherapy.     This treatment is associated with long term side effects in around half of patients with up     to 10% suffering from grade 3-4 toxicity.      The development of intensity modulated radiotherapy (IMRT) allows for shaping of radiotherapy     fields to reduce the doses delivered to organs at risk (OARs). This does appear to reduce the     risk of long and short term toxicity (although there is little randomized evidence). However     pelvic organ position varies both between and even during radiotherapy fractions; this means     that radiotherapy margins must be generous to allow adequate coverage of the clinical target     volume (CTV) but this also increases dose to OARs.      There have been a number of studies evaluating pelvic organ motion in cervical cancer as well     as assessing different adaptive radiotherapy strategies. These have included individualized     margins, plan of the day and adaptive techniques. Most of these studies have been carried out     using cone beam computed tomography (CBCT) imaging which is often poor quality with limited     soft tissue contrast. MR offers better visualization of the tumour and OARs and is used for     imaged guided brachytherapy treatment.      This study will explore the role of MR imaging in adaptive radiotherapy for cervical cancer     with development of a number of theoretical treatment strategies.   "
14070|NCT03101293|"     The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of     TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK     of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy     participants.   "
14071|NCT03101280|"     This is a Phase Ib, open-label, non-randomized study in participants with advanced     gynecological cancers (Part 1) and platinum-sensitive ovarian cancer (Part 2) to investigate     the dose, safety, pharmacokinetics, and efficacy of rucaparib in combination with     atezolizumab. The study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a     Dose-Expansion Phase (Part 2).   "
14072|NCT03101267|"     The objective of this study is to evaluate the efficacy, safety, and dose-response of ASP4070     vaccinated in patients with cedar pollinosis.   "
14073|NCT03101254|"     This research study is studying a combination of targeted therapies as a possible treatment     for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation      The interventions involved in this study are:        -  LY3022855        -  Vemurafenib        -  Cobimetinib   "
14074|NCT03101241|"     This is a double-blind, placebo-controlled, parallel-group study. Subjects will be randomized     to one of two treatment groups. Group A will receive CX-8998 and Group B will receive     placebo. Subject randomization will be stratified by concomitant primidone use and site type     (sub-study vs non sub-study).   "
14075|NCT03101228|"     The most important objective of this randomized controlled trial in subjects with increased     cardiovascular and metabolic risk factors is to investigate whether only reduced daily     sitting improves human cardiovascular and metabolic health during a six-month intervention.     It is hypothesized and expected that only reduced sitting, without formal physical activity     or exercise training, affects favorably cardiovascular and metabolic health.   "
14099|NCT03100916|"     The primary objective of the trial is to investigate the safety and tolerability of BI 690517     in healthy male subjects following oral administration of multiple rising doses over 14 days     (MRD part).      Secondary objectives for the MRD part are the exploration of PK (Pharmacokinetic(s)),     including dose proportionality, as well as investigation of linearity and PD     (Pharmacodynamic(s)) of BI 690517 after multiple dosing.      For the FE (food effect) part, the secondary objective is to investigate the relative     bioavailability of BI 690517 under fasted conditions (Reference, R) compared to BI 690517     (single dose) after a high fat high caloric breakfast (Test, T).   "
14076|NCT03101215|"     Phosphorus is a widely used sport supplement. Most athletes who use it follow a phosphorus     loading approach which consists of a weeklong phosphorus intake of 3-4 gr per day for optimal     effect. The ergogenic potential of phosphorus is believed to be related to several factors     including its ability to a) enhance ATP availability for energy expenditure and b) increase     plasma content of 2.3-DPG (2.3-disphosphoglycerate) that is known to reduce oxygen affinity     to hemoglobin and consequently enhances its release in the exercising tissue. Additionally,     phosphorus was reported to increase peripheral glucose uptake and thus glycogenesis and     glycogen storage. We have recently observed that the peripheral glucose uptake was stimulated     by co-ingestion of phosphorus with meal, while pre ingestion failed to do so. Thus it is     reasonable to postulate that phosphorus co-ingestion with meal improves ergogenesis through     enhancing glycogen storage. The aim of this experiment is to investigate whether acute     phosphate supplementation of a glucose load is responsible for the performance enhancement.     This may help in explaining the controversies surrounding the impact of phosphorus on     performance. A cross over study will be conducted on water polo players. In brief, overnight     fasted subjects, will be given glucose load with or without phosphorus. Three hours later     their performance will be measured using an ergometer cycling machine.   "
14077|NCT03101202|"     Ventilator Associated Pneumonia (VAP) is associated with increased hospitalisation, increased     health care cost and high morbidity and mortality. The incidence of VAP increases with     duration of mechanical ventilation. There is limited data especially from India on the     incidence of VAP and also the role of subglottic aspiration in its prevention. The aim of     this study is to determine the role of subglottic suction in the incidence of VAP.   "
14078|NCT03101189|"     So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will     bridge results obtained in Caucasian subjects to those in Japanese subjects.   "
14079|NCT03101176|"     Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of     the available techniques, lead to over- and undertreatment for a significant fraction of     patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality     combining different ultrasound parameters, heralds the potential for an accurate     imaging-based diagnostic approach accessible to the community at large but formal validation     of mpUS against final pathology results are still lacking.      Objective: To validate mpUS as imaging modality for detection and localization of prostate     cancer by direct correlation with histopathology of radical prostatectomy specimens   "
14165|NCT03100045|"     This open label study investigates a novel non-surgical approach to the treatment of     HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.   "
14080|NCT03101163|"     This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled,     parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage     lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy     of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic     acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC     therapy can improve functional outcome and reduce pain of the knee joint better than a     standard treatment (HA injections and physiotherapy regimen).   "
14081|NCT03101150|"     Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine     daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose     (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia     cases.   "
14082|NCT03101137|"     Caudal epidural anesthesia is one of the most common regional techniques used for     post-operative pain management in pediatric patients. In this study we are going to compare     the effects of caudal bupivacaine , caudal Dexamethasone with bubivacaine and Dexmedetomidine     with bupivacaine on the systemic vascular resistance and the cardiac output, in pediatric     patients undergoing lower abdominal surgeries, by using the electrical cardiometry (EC).   "
14083|NCT03101124|"     Tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces     bleeding. It is routinely given intravenously in many surgical situations where there is a     risk of major bleeding. Concerns regarding possible adverse effects from intravenous use     prevents a more widespread use, even in smaller surgeries. Topical application - using the     drug directly on the wound surface- may give a higher concentration at the site of bleeding     but a lower concentration in the rest of the body, and hence a lower risk of adverse effects.     Here it will be investigated to what extent a defined dose of the drug is absorbed     systemically - into the blood stream - when it is applied topically. This will then be     compared to the concentration in the blood stream when administered intravenously. Blood     samples will be obtained at defined time intervals after administration from patients     receiving topical and patients receiving intravenous administration of the same single dose     of tranexamic acid. Will less of the drug enter the blood stream if it is applied directly to     the wound?   "
14084|NCT03101111|"     The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a     previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will     be assessed.      MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will     receive MV-CHIK; 20% will receive MMR vaccine.   "
14085|NCT03101098|"     This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge     uterus.   "
14086|NCT03101085|"     By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen     in the body, causes an increase in mitochondrial activity. Researchers also hope to determine     the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences     cognition.   "
14087|NCT03101072|"     Gram-negative bacteremia (GNB) is a frequent hospital & community-acquired infection, yet     there is as yet no evidence from randomized studies on the optimal duration of antibiotic     therapy. This point-of-care, multicenter randomized controlled non-inferiority trial will     randomize 500 patients with GNB on day 5 of appropriate antibiotic therapy to either (1) a     total of 7 days of antibiotic therapy, (2) a total of 14 days of antibiotic therapy, or (3)     an individualized duration of antibiotic therapy (guided by the patient's clinical course &     C-reactive protein levels). The primary outcome is the incidence of clinical failure at day     30.   "
14100|NCT03100903|"     The primary objective of this trial is to investigate the relative bioavailability of BI     655130 following subcutaneous administration (Test, T) compared to BI 655130 following     intravenous infusion (Reference, R).      The secondary objective is the evaluation and comparison of several pharmacokinetic     parameters between all tested treatments.   "
14089|NCT03101046|"     This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6     cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel     resistant mCPRC defined as ≥ 5CTCs/7.5ml after 2 cycles of docetaxel.      Patients with docetaxel resistant metastatic castration-resistant prostate cancer (mCRPC)     based on circulating tumor cell (CTC) enumeration (patients with ≥ 5CTCs/7.5ml before     docetaxel chemotherapy and after 2 cycles of docetaxel) will receive either 6 additional     cycles of docetaxel or 6 additional cycles of cabazitaxel after randomisation.      A cohort of patients with docetaxel sensitive metastatic castration-resistant prostate cancer     (mCRPC) based on circulating tumor cell (CTC) enumeration (patients ≥ 5CTCs/7.5ml before     docetaxel chemotherapy and < 5CTCs/7.5ml after 2 cycles of docetaxel) will receive 6     additional cycles of docetaxel   "
14090|NCT03101033|"     The purpose of this study is to determine whether epidural neuroplasty has better efficacy     than epidural steroid injection for the treatment of lumbar disc herniation.   "
14091|NCT03101020|"     Non-specific chronic low back pain is a common multifactorial condition common to the world     population. It is defined as a pain and discomfort located below the ribs and above the     gluteal folds that may or may not have referred pain in the leg for more than 12 weeks.     Visceral manipulation is a manual therapy technique that aims to normalize mechanical,     vascular and neurological dysfunctions of the viscera with the objective of improving its     functioning. Visceral dysfunction may potentially activate or exacerbate the symptoms of low     back pain in the presence of compromised movements between the internal organs and its     connective tissues. There are two ways in which a change in visceral mobility could interfere     with low back pain, referred visceral pain and central hypersensitivity. The first occurs due     to neural convergence, since there is no spinocortical tract that only sends visceral or     somatic afferences, its afferences are crossed in the dorsal horn of the spinal cord. The     second is that the prolonged and continuous activation of nociceptors, due to the alteration     in the mobility of the gastrointestinal and urinary system, can generate central     hypersensitivity. Therefore, the investigators hypothesized that through the visceral     manipulation the fascial adherences would lyse and the visceral spasms would demise, reducing     the peripheral input, thus, lessening pain in the low back.   "
14166|NCT03100032|"     A prospective multi-centre, randomised, controlled study to evaluate the safety and     preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar     spondylolisthesis by interbody fusion (L1 - S1).   "
14092|NCT03101007|"     The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement     with a good clinical track record and good survival rates.      The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has     been designed to provide better range of motion and address the unstable feeling some     patients experience during everyday activities, such as stair descent and bending. It is     expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval     early 2016. Patient inclusion will start after regular approval has been obtained.      The objective of this study is to accurately assess and compare migration, clinical and     radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the     Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete     Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy     Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32     patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included.      The study population will consist of patients with symptomatic osteoarthritis of the knee     scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The     Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95%     is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished     within a 1 year period and that the total study duration is 3 years.      Main study parameters/endpoints are:        -  Migration, measured by means of RSA.        -  Patient Reported Outcome Measures by means of questionnaires.   "
14093|NCT03100994|"     Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum     block versus ultrasound-guided quadratus lumborum type II block   "
14094|NCT03100981|"     AIM: The aim of the present study is to investigate if Internet-delivered Mindfulness-Based     Cognitive Therapy (I-MBCT) can reduce symptoms of depression and anxiety among women treated     for breast cancer and men treated for prostate cancer compared to a treatment as usual     control group. Furthermore, the effect of I-MBCT on symptoms of stress, insomnia, quality of     life, and self-compassion and the potential mediating effect of working alliance and     mindfulness will be explored. Finally, the cost-effectiveness of the I-MBCT intervention will     be explored.      BACKGROUND: Symptoms of depression, anxiety, and stress are prevalent late-effects among     cancer patients and -survivors. Mindfulness-based interventions aim at improving affect     tolerance and emotion regulation, which could be of particular relevance for cancer patients     and survivors, and MBCT has been shown efficacious in treating symptoms of depression,     anxiety, and stress among cancer patients and survivors. However, the availability of     face-to-face delivered MBCT is limited and hence using the internet to deliver MBCT may be a     cost-effective way of increasing the accessibility of the intervention to vulnerable patients     with limited resources.      METHODS: A total of 155 participants will be recruited from Department of Oncology and     Department of Urology at Aarhus University Hospital and randomized to two groups: I-MBCT and     a treatment-as-usual wait-list control group. Assessments will be conducted at pre-, midway     and post intervention and at a 6- months follow-up.   "
14095|NCT03100968|"     This study will address the utility of ultrasound in the placement of an epidural catheter in     severely obese parturients. Identification of midline can often be difficult using the     standard method of palpation in obese patients. The Investigator will determine if the use of     ultrasound decreases the amount of time and number of attempts required to place the     epidural.   "
14096|NCT03100955|"     To establish the progression free survival in patients with extensive stage small cell lung     cancer treated with cisplatin and etoposide plus or not apatinib   "
14097|NCT03100942|"     The primary objective of this study is to assess the efficacy of filgotinib, GS-9876, and     tirabrutinib (formerly GS-4059) in adults with active Sjogren's Syndrome (SjS).   "
14098|NCT03100929|"     The investigators aim to prove that minimal sonographic training for nuchal cord detection in     an unexperienced first year medical resident is more than enough to detect the phenomenon.     Patients undergoing elective cesarean section will undergo a routine ultrasound (that is     performed to detect the fetal heart rate and the fetal presentation) during which the     resident will attempt to detect nuchal cord. The resident will then attend the patient`s     surgery to verify the findings.   "
14101|NCT03100890|"     In this work the importance of the potentiation and recovery of the balance with a     physiotherapeutic intervention that begins in the early preoperative phase is compared with     the conventional postoperative rehabilitation. The objective is to evaluate the influence of     a muscle enhancement protocol in which a specific work of balance is included, with the     physical benefits that this entails for the evolution of the patient. It also seeks to verify     if the teaching and recommendation of exercises at home as preparation and conditioning for     the intervention of ATR is effective, and to what extent, compared to a guided training in     the hospital.   "
14102|NCT03100877|"     This phase I/II trial studies the side effects and best dose of melphalan and total marrow     irradiation and how well they work with autologous stem cell transplantation in treating     patients with high-risk multiple myeloma. Drugs used in chemotherapy, such as melphalan, work     in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Total marrow irradiation is     a type of radiation therapy and a form of total body irradiation that may deliver focused     radiation to the major marrow sites where cancer cells reside. Giving chemotherapy and     total-body irradiation before a peripheral autologous blood stem cell transplant helps kill     any cancer cells that are in the body and helps make room in the patient's bone marrow for     new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from     the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow     for the stem cell transplant. The stem cells are then returned to the patient to replace the     blood-forming cells that were destroyed by the chemotherapy.   "
14103|NCT03100864|"     The primary objective of this trial is to understand the mechanism of action of BI655130 in     patients with UC      Secondary objectives are to explore clinical effect, safety and tolerability (including     immunogenicity) of BI 655130 treatment   "
14104|NCT03100851|"     Constipation is a prevalent intestinal disorder. Lactobacillus casei strain Shirota (LcS)     shows potential effect on alleviating constipation. This study evaluated the impact of     fermented milk containing LcS on stool consistency and frequency. The stool short chain fatty     acid and gut microbiota were also assessed.   "
14105|NCT03100838|"     The purpose of this study is to measure the amount of study drug present in blood after being     administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant     Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg     (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid),     omeprazole/sodium bicarbonate capsules, 40 mg/1100 mg (generic) on separate occasions, on an     empty stomach. This study also involves administrations of an FDA-cleared capsule,     SmartPill™, which will measure stomach acid, prior to each study arm.   "
14106|NCT03100825|"     The purpose of this study is to provide long term safety data of QVM149 in Japanese patients     with asthma for the registration of QVM149 in Japan.   "
14107|NCT03100812|"     The proposed intervention is part of a multi-year year grant awarded to the NYU Center for     the Study of Asian American Health by to the National Institutes of Health/National Center     for Minority Health and Health Disparities (NIH/NCMHD). The funding mechanism is specifically     the NCMHD Community-Based Participatory Research (CBPR) Initiative in Reducing and     Eliminating Health Disparities: Intervention Research Phase (R24).      The objective of this study is to implement and assess the efficacy of a Community Health     worker (CHW) intervention to improve hypertension management and access to care among     Filipino Americans living in New York and New Jersey. It is believed that when compared to     individuals receiving the less intensive CHW intervention, Filipino Americans receiving the     more intensive CHW intervention will:      H1: Exhibit greater compliance with appointment keeping. H2: Exhibit greater compliance with     medication taking H3: Show greater reductions in mean systolic and mean diastolic blood     pressure. H4: Be more likely to exhibit controlled blood pressure   "
14108|NCT03100799|"     This is an exploratory non-drug, interventional biomarker study in approximately 30 eligible     patients with active osteoarthritis to investigate the degree of senescence-associated     disease. Patients will provide blood and urine and undergo MRI imaging with and without     gadolinium enhancement. Following imaging, arthrocentesis of both knees and an arthroscopy of     the target knee will occur to obtain fluid, synovium and cartilage for analysis.   "
14109|NCT03100786|"     The primary objective is to determine whether Leukotriene A4 hydrolase (LTA4H) genotype,     defined at randomisation, determines dexamethasone's clinical effectiveness when added to the     first 6-8 weeks of anti-tuberculosis treatment of TBM. The investigators will conduct a LTA4H     genotype stratified, parallel group, randomised, double blind, placebo-controlled     multi-centre Phase III non-inferiority trial evaluating dexamethasone versus placebo for 6-8     weeks in addition to standard anti-tuberculosis drugs.      The investigators will take a hybrid trial-design approach which assumes a modest harm of     dexamethasone and aims to prove non-inferiority of placebo first but also allows claiming     superiority of placebo in case dexamethasone causes substantial harm. Moreover, as it is     possible that harm of dexamethasone only applies to the LTA4H CC genotype, the trial will     allow dropping the CT group at an interim analysis but continue randomization of the CC     group.      In making this assessment the investigators not only determine whether dexamethasone     influences survival and the incidence of new neurological events (the primary endpoint), but     also whether it influences disability assessed by the modified Rankin score 12 months after     the start of treatment.      The secondary objective is to investigate alternative management strategies in a subset of     patients who develop drug-induced liver injury that will enable the safe continuation of     rifampicin and isoniazid therapy whenever possible.   "
14110|NCT03100773|"     This study evaluated the impact of atraumatic restorative treatment associated with oral     health educational strategy on dental anxiety, oral health-related quality of life and     salivary biochemical and microbiological characteristics of Brazilian schoolchildren.   "
14111|NCT03100747|"     The purpose of this study is to determine whether the rate of post-operative trachomatous     trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision     height of 3mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut     surgery.   "
14148|NCT03100266|"     Probiotics for spinal inflammatory end-plate changes, so-called Modic changes, a randomised     controlled study      Modic changes are inflammatory end-plate changes primarily affecting the lower lumbar levels.     They are associated with disc degeneration, disc herniation and age, and are only seen on     magnetic resonance imaging of the lumbar spine, not on X-ray. Three different types of Modic     changes have been described, type 1, 2 and 3, the latter being rare [5]. It has been shown     that type 1, but not type 2, is associated with more intense low back pain (LBP) and worse     LBP outcome including a lower rate of return to work [7]. In addition, more inflammatory     cells have been identified in this type of structural abnormality [25]. Modic changes may     affect up to 20% of the general population and more than the double proportion in clinical     populations, type 1 and 2 being about equally represented [6]. The investigators have     estimated that at least 5,000 of the patients, who are referred to secondary health care in     Denmark for LBP per year, will suffer from type 1 Modic changes.      Based on a hypothesis of infection as the cause of Modic changes, a randomised clinical trial     with one year follow-up has been performed [16]. This trial documented significant effect of     long-term (100 days) broad-spectrum antibiotic treatment (amoxicillin/ clavulanic acid) in     patients with type 1 Modic changes. However, infection in Modic changes has not been     documented convincingly in this or in other studies, and almost all of the treatment effect     occurred after the antibiotic treatment was stopped. As yet, the study has not been     replicated. The investigators hypothesize that the treatment effect may have been caused by     an effect on the gut microbiom possibly explaining the delay of the effect.      Probiotics have been shown to influence interleukins in patients with inflammatory conditions     and in healthy volunteers [32, 36, 37].      The investigators are therefore performing a randomised trial to study the clinical effect of     probiotics on type 1 Modic changes as well as the effect on interleukin levels. The trial is     designed as a randomised, clinical, double blind, placebo-controlled trial taking place at     the Spine Center, Silkeborg Regional Hospital. Power calculation was based on a smaller     treatment effect than the effect found in the study above and resulted in the requirement of     including 94 patients. One-year follow-up is planned.      The investigators use lactobacillus rhamnosus GG (Dicoflor®) for the trial, as this strain     has been used in several clinical studies. The dietary supplement has been shown to influence     relevant interleukins significantly, and it has been proven to be stable in action and safe,     also in pregnancy.      A positive result of such a trial may have significant consequences. The perspective of using     probiotics instead of antibiotics in this common disorder is very attractive. At the time     being, many type 1 Modic patients in Denmark and other western countries are treated with     antibiotics. This is of great concern because of side effects and possible drug resistance     development of bacteria.      The Technology Transfer Office of Aarhus University is involved.   "
14149|NCT03100253|"     To compare the efficacy of switching to a different molecular target (from TNF to IL6) versus     cycling to a second TNF inhibitor in patients with active RA, who have not adequately     responded to a previous treatment with a first anti-TNF.   "
14112|NCT03100734|"     The primary objective is to evaluate the effectiveness of Benepali in participants with     Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with     Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from     treatment with Enbrel.      The secondary objectives of this study are to evaluate safety during and following the     transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and     following the transition from Enbrel to Benepali.   "
14113|NCT03100721|"     Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high     socio-economic costs, with many negative effects on quality of life. CMP affects the ability     to perform work, social, recreational and domestic tasks by changing the mood and     concentration of this population that suffers.      In a study carried out in 2010, 17% of the Spanish population had experienced pain in the     last month and according to the severity of symptoms 12% felt severe , 64% moderate and 24%     mild pain. In this same study it is specified that 61% was due to back pain, 29% due to neck     pain and 23% due to shoulder pain.      Pain neuroscience education (PNE) has been shown as an effective treatment strategy in     increasing knowledge and understanding of neurobiology, neurophysiology and pain processing,     modifying beliefs about it, improving patient skills and encouraging to the accomplishment of     physical and social activities in different chronic pathologies.   "
14114|NCT03100708|"     The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian,     gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic     laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall     Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed     before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum)     are collected with every PIPAC intervention to follow up and to document the individual     success or progress of the patients. The advice of the tumor board is mandatory to confirm     the indication for local chemotherapy (PIPAC).   "
14201|NCT03099577|"     The goal of this study is to find the maximum tolerable dose of radiation that can be     delivered combined with chemotherapy (carboplatin & paclitaxel) in patients with stage III     non-small cell lung cancer (NSCLC).   "
14116|NCT03100682|"     Due to their immunosuppressive therapy, solid-organ transplant (SOT) recipients bear a 10 to     100 times higher risk of human papillomavirus (HPV)-associated malignancies than healthy     individuals. The objectives of this observational, non-interventional multi-national,     multi-centre research project are to gain an insight into current HPV vaccination strategies     and to investigate the immune response to different routinely administered HPV vaccines in     European paediatric SOT candidates and immunocompromised transplant recipients, enabling     patients at risk of vaccination failure to be identified.   "
14117|NCT03100669|"     MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or     carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the     patient. Surgery is often associated with severe postoperative pain. In this study the     researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short     and long term follow up.   "
14118|NCT03100656|"     This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a     differential meal-induced metabolism and response compared to healthy controls, and     determines how genetic variation influence this difference.   "
14119|NCT03100643|"     HIV/AIDS among Black men is a US public health crisis, emphasizing the urgency for increased     research focus and intervention development. The overall objective of this application is to     achieve a better understanding of the role that dyadic factors play in individual-level HIV     care engagement outcomes among HIV-positive Black men in romantic relationships. The end goal     is the development of an intervention that employs innovative mobile technology to target     partnership dynamics that optimize outcomes in the HIV care continuum.   "
14120|NCT03100630|"     Randomized study in healthy men and women. Assess the similarity of BMS-986089 when injected     into the arm, thigh, or the stomach. Collect data on safety of BMS-986089.   "
14121|NCT03100617|"     This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of     a Alzheimer's family caregiver intervention in Vietnam.   "
14122|NCT03100604|"     The investigators aimed to examine the effect of sevoflurane and desflurane, agents used in     patients who do not have any ear pathology and undergo surgery under general anesthesia, on     the MEP.   "
14123|NCT03100591|"     The primary purpose of this study is to investigate the rate and routes (urine and feces) of     elimination of ACT-132577, and the mass balance in urine and feces   "
14124|NCT03100578|"     RANDOMIZED MULTICENTER STUDY COMPARING PLASTIC STENTS AND SELF-EXPANDING METALLIC STENTS IN     THE EUS-GUIDED TRANSMURAL DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS.      SPANISH CENTERS PARTNERS OF THE SPANISH SOCIETY OF DIGESTIVE ENDOSCOPY   "
14125|NCT03100565|"     Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical     cancer is performed with the cervical biopsy which is guided by the colposcopy. The     colposcopy guided cervical biopsy creates pain and several methods have been reported to     overcome the pain related with this procedure. Local anesthetic agent injection into the     cervix has been studied and found to be effective and also, forced coughing was compared with     local anesthetic injection and it is found to be more effective. In fact local injections can     create the pain by itself.However no study compared the effect of forced coughing to local     anesthetic spray. The study aims to evaluate the comparison of forced coughing with local     anesthetic spray with respect to perceived pain during colposcopy guided biopsy.   "
14126|NCT03100552|"     Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >=     8mm in size   "
14183|NCT03099811|"     Secondhand smoke exposure (SHSe) is one of the most common and potentially modifiable     environmental triggers for asthma. Financial incentivization may serve as an effective     modality to reduce SHSe among pediatric asthmatics with potential down-stream benefits on     improved asthma control and subsequent reduced healthcare utilization. This study plans on     testing the feasibility and effectiveness of financial incentives to decrease SHSe, derived     from primary caregivers and a member of their social network, of children with persistent     asthma.   "
14127|NCT03100539|"     Given the modest effectiveness of current treatments and the burden chronic neck pain places     on Veterans, the investigators' research proposal is significant in several regards. First,     Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) Study directly     addresses a high priority area for the VA and is well aligned with the VHA Pain Management     Strategy and VHA Pain Management Directive 2009-053. Second, because previous massage studies     have included relatively small sample sizes, this trial will provide information vital to     fill an evidence vacuum regarding effectiveness of two different massage treatments for     chronic neck pain. Third, TOMCATT will extend the current understanding of     non-pharmacological treatments. Fourth, if the study hypotheses are corroborated massage may     emerge as an effective, safe, affordable, sustainable, and accessible treatment for Veterans.   "
14128|NCT03100526|"     Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively     manages Veterans at the highest risk for hospital admission and death while they are still in     the ambulatory care setting.      Goal:        -  Reduce emergency department and urgent care utilization, hospitalization, and mortality          in complex, high risk patients        -  Improve Veteran and staff satisfaction      Objectives:        -  Maintain the patient in the home setting as much as possible        -  Secure appropriate home environment to facilitate health and well-being        -  Utilize comprehensive team-based care        -  Engage appropriate Veteran Health Administration (VHA) programs to provide          interdisciplinary, coordinated, and timely management of complex medical issues   "
14129|NCT03100513|"     The current standard of care for patients with HE includes non-absorbable     disaccharides(lactulose);The chemical name for lactulose is     4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to     be the conversion to lactic acid and acetic acid by colonic bacteria resulting in     acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+),     which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon.     Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of     nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing     the gut of ammonia before it can be absorbed.   "
14130|NCT03100500|"     The purpose of this study is to provide long term safety data of QMF149 in Japanese patients     with inadequately controlled asthma for the registration of QMF149 in Japan.   "
14131|NCT03100487|"     The purpose of this study is to:        1. Determine if audio recorded guided imagery vs deep breathing exercises delivered via a          digital media player improves abdominal pain symptoms in children with functional          gastrointestinal pain disorders managed in the primary care setting.        2. Determine if audio recorded guided imagery and deep breathing exercises delivered via a          digital media player improves psychosocial distress in children affected by functional          gastrointestinal pain disorders managed in the primary care setting.      The possibility of treating functional gastrointestinal pain disorders using remotely     delivered psychosocial therapies has the potential to treat many children affected by     functional gastrointestinal pain disorders in a cost-effective manner. This study will     provide insight into how well these patients in the primary care could benefit from such     interventions.   "
14132|NCT03100474|"     A global post approval study to collect safety and effectiveness data related to ExAblate     Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement     Disorders, or Neuropathic Pain within the thalamus and/or pallidum.   "
14133|NCT03100461|"     The goal of this study is to find the best ways to increase colorectal cancer (CRC)     screening.   "
14134|NCT03100448|"     A 1-year Clinical Investigation on the On1 Concept.   "
14135|NCT03100435|"     The American Association of Oral and Maxillofacial Surgeons estimated that 69% of adults ages     35 to 44 have lost at least one permanent tooth. Dental implants have revolutionized     dentistry by providing tooth-like replacement for missing teeth and a solution that is     predictable with long-term success..      After the implant is placed, natural bacteria from the mouth can develop around implants just     like around natural teeth. Studies have shown that bacterial contamination can cause     peri-implantitis- gum disease or inflammation around the implant, eventually leading to bone     loss. Removing bacteria from dental implant surfaces can prevent peri-implantitis, and     surface debridement constitutes the basis of treatment of peri-implant disease.      Typically, mechanical hand instrumentation using curettes to remove biofilm and calculus is     the main basis for periodontal therapy. However, total debridement is difficult, and the hand     tools may damage the surface of the implant and making it more plaque retentive. Studies have     shown that mechanical non-surgical therapy alone is not sufficient to treat peri-implantitis.      There is evidence that a dental laser may be an effective method to remove bacteria from     implant surfaces, with less damage to the surface. One type of dental laser, Er:YAG, appears     optimal for implant decontamination as the Er:YAG laser energy is primarily absorbed by     water, resulting in vaporization of bacteria and minimal surface alterations on the implant     surface.The aim of this study is to evaluate the efficiency of biofilm decontamination of     Er:YAG laser compared to carbon fiber curette.   "
14136|NCT03100422|"     Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the     arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even     alternative for neurorehabilitation training.   "
14150|NCT03100240|"     NF-κB pathway activation-induced endometrial insulin resistance was one of the causes of     infertility patients with PCOS and insulin resistance whose endometrial receptivity is     declined .The investigators' previous findings indicated that the use of modified utral-long     protocols ( GnRH-a was used twice in mid-luteal phaes) can improve clinical outcomes by     improving endometrial receptivity in patients with PCOS , but the mechanism was not clear.     Previous research also found that GnRH-a reduced the activity of NF-κB pathway in endometrial     stromal cells and depended the dose and time.Thus, The investigators' subject will try to     applicate GnRH-a to explore the influence of NF-κB pathway activity 、the state of insulin     resistance and embryo implantation rate ;then we will investgate GnRH-a whether reduce NF-κB     pathway activity-induced insulin resistance and ultimately improve endometrial receptivity by     using GnRH-a in infertility patients with PCOS and insulin resistance.The investigators'     research attempt to provide ideas for seeking inflammatory medication target in assisted     reproductive technology in patients with PCOS by exploring the immune mechanism of GnRHa on     improving the endometrial receptivity .   "
14137|NCT03100409|"     In Mexico, cervical cancer (CC) ranks second in incidence and mortality among women. The     National Institute of Cancer in Mexico (lNCan) receives annually about 500 patients with CC,     80% of which are diagnosed with locally advanced disease. The standard treatment for locally     advanced disease consists in concomitant chemo-radiotherapy based on cisplatin (QT-RT),     followed by brachytherapy, with an absolute benefit of 10%. Adverse effects include     gastrointestinal toxicity, which is the most important factor limiting the dosage of pelvic     radiation. Cancer treatment, in any modality, induces malnutrition, more so when combined     treatments are administered. Radiation induced gastrointestinal toxicity is caused by     different factors, among which are malabsorption of bile, fat and carbohydrates, decrease in     brush border enzymes, diverticular disease, proctitis, and psychological factors.     International guidelines for cancer patients recommend nutritional assessment in these     patients before they start treatment, so nutritional risk can be detected and the patient may     get started on dietary intervention to prevent malnutrition. Several authors have studied the     dietary management that may help reduce the gastrointestinal effects in cancer patients     receiving pelvic radiotherapy. To reduce diarrhea and prevent malnutrition the recommended     dietary approach is a low residue diet consisting on 20-25% kcal from fat, 5g of lactose and     20g of fiber. Currently the INCan does not follow the nutrition care process for cervical     cancer patients; written recommendations are given to the patients with a list of foods     allowed or not allowed, with no further nutritional assessment or intervention. From previous     studies, the investigators have demonstrated that the current recommendations do not help the     patients maintain their nutritional status, during their treatment most patients become     malnourished (81%, p<0.01). Therefore, the aim of this clinical trial is to evaluate a diet     low in residue in CC patients, considering the necessary modifications for each patient if     morbidities are present, in comparison with the current dietary recommendations used in the     INCan.   "
14138|NCT03100396|"     DREAMY is a prospective, multi-centre observational cohort study using a mixed methods     approach to provide quantitative and qualitative data on accidental awareness under general     anaesthesia (AAGA) in obstetric surgery patients. Obstetric patients undergoing surgery, such     as emergency caesarian section under general anaesthesia, are thought to be at higher risk     than any other surgical cohorts for AAGA. Patients recruited to the study will be screened     for AAGA using a standardised questionnaire on three occasions over 30 days. Follow up with     structured interviews for all AAGA patients will occur over 12 months.   "
14139|NCT03100383|"     To assess the association of the number of medical nutrition therapy (MNT) consultations and     eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in     women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).   "
14206|NCT03099512|"     The purpose of this study is to investigate the effects of Short Foot Exercises on pain,     biomechanical characteristics and functionality of lower extremity in patients with     patellofemoral pain.   "
14140|NCT03100370|"     This study will compare different polarities of transcutaneous spinal direct current     stimulation combined with robotic-assisted arm training in adults with acquired brain injury     (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham     transpinal direct current stimulation (tsDCS) over cervical spine combined with high     intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.   "
14141|NCT03100357|"     The pronounced effect of goiter on the esophagus needs further exploration, as the mechanisms     by which goiter leads to swallowing difficulties are unknown. By investigating esophageal     motility using high resolution esophageal manometry before and after thyroidectomy we seek to     examine the impact of the goiter mass on the esophagus and swallowing with six months     follow-up.   "
14142|NCT03100344|"     The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab     in moderate-to-severe AD subjects with severe pruritus receiving TCS, who were not adequately     controlled with topical treatments.   "
14143|NCT03100331|"     Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays     and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children     who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and     neglect. While cognitive and psychiatric issues have been described in HIV-infected children,     and even more so in HIV-positive adults, there have been no reports on neuropsychiatric     interventions that can improve cognitive and psychiatric states in this highly vulnerable     population. Without these needed data, Pediatric HIV providers have not been able to advocate     for optimal neuropsychiatric care in perinatally HIV-infected children, let alone those who     has suffered the additional risk of being internationally adopted. In the proposed study, the     investigators will report on the neuropsychological profiles and outcomes in a cohort of     internationally-adopted, perinatally HIV-infected children between ages 6 to 16 years who     have not previously undergone neuropsychological testing or treatment. Data obtained from     this study will provide important contributions to the literature by building understanding     of the complex needs of this population as well as guiding future intervention efforts. The     investigators predict that intervention efforts aimed at helping educators understand the     learning and cognitive challenges for many of our patients will guide targeted academic     supports in the school setting and lead to gains in academic skills. The detailed information     obtained during the comprehensive neuropsychological assessment and follow-up care will be     shared with the child's key educators at school so that individualized educational strategies     can be developed, while maintaining confidentiality regarding the child's HIV status.   "
14144|NCT03100318|"     FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for     14 weeks to compare the efficacy and safety of these drugs by the method of multicenter,     randomized, double-blind, ascending dose regimen.   "
14145|NCT03100305|"     The aim of this study is to investigate the changes of amino acid metabolic profiles in     different nutritional stages of preterm infants and determine the effects of nutritional     intervention on the amino acid metabolic status of preterm infants.   "
14146|NCT03100292|"     This trial is a multi-center, single-arm, prospective, observational cohort study of patients     undergoing primary bariatric surgical procedures in Korea. A total of 100 patients will be     recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up     period of 1 year after surgery. The eligible subjects who have given their consent to     participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y     gastric bypass.      The primary objective of this clinical trial is to measure the changes in body weight (kg)     and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary     outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension,     type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life.     Additionally, postoperative incidences of morbidity and mortality, micronutrient status, body     composition, and cost-effectiveness of surgical intervention will be examined.   "
14147|NCT03100279|"     The current study will evaluate the predictors, mediators, outcomes, and critical therapy     processes associated with manual-based psychological therapies for 400 youth (ages 7-16     years) with anxiety and/or depression seeking services within a semi-natural clinic setting.     Essentially, this study seeks to determine what works about psychological therapy for     youth.   "
14151|NCT03100227|"     Epilepsy is the most common chronic neurological disorder in the world, affecting more than     50 million people worldwide.      Approximately 35% of patients with epilepsy are refractory to all available antiepileptic     drugs. Focal Hypometabolism on interictal [18F]-FDG PET is a hallmark of the Seizure Onset     Zone as well as surrounding areas. Using [18F]-FDG PET is thus particularly useful to     determine the seizure onset zone of epileptic patients and thus to guide surgical treatment     when antiepileptic drugs fail.      Interpretation of PET images primarily relies on standard visual analysis, but statistical     analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the     diagnostic yield of PET. Over the past years, some authors have thus reported that the use of     SPM can result in greater sensitivity and specificity of PET imaging in patients with partial     epilepsy.      In order to perform statistical analysis of PET images to compare brain metabolism of     epileptic patients and healthy controls, it is necessary to collect a normative database of     [18F]-FDG PET images in healthy controls.      The purpose of this study is (i) collect a normative database of [18F]-FDG PET images in     healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for     non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of     [18F]-FDG PET scanning.   "
14152|NCT03100214|"     Studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen     consumption, reduce effort-induced lactic acid production, and increase skeletal muscle     oxidative capacity, as well as psychological aspects such as increased self-esteem and     improvement of the quality of life.      In the literature there is only one study involving rehabilitation in hospitalized pediatric     patients with cystic fibrosis. Thus, more information on in-hospital rehabilitation is     required in adult cystic fibrosis patients.      The present study aims to evaluate the effects of an early rehabilitation program, based on     aerobic training and muscle strength training, in adolescent and adult patients with cystic     fibrosis hospitalized at Hospital de Clinicas de Porto Alegre for exacerbation of lung     disease.   "
14153|NCT03100201|"     In this study, patients with upper arm fracture will receive an additive robotic-assisted     training using the Armeo®Spring robot for three weeks on the injured arm in addition to     conventional physio- and occupational therapy. The supportive treatment and execution of     specific exercises on the Armeo®Spring should lead to improved recovery of function and     mobility of the upper arm compared to conservatively treated patients.   "
14154|NCT03100188|"     This study aims to use modified peritoneal dialysis prescriptions to achieve adequate     clearance and volume removal while decreasing the number of exchanges or time spent on     dialysis, evaluating maintenance of residual renal function, and improving quality of life.   "
14155|NCT03100175|"     Frailty, one of geriatric syndromes, is considered a major obstacle for recovery from     physiological stress. Such stress is imposed on patients with cancer by virtue of the disease     itself but even more so by the treatment. Moreover, malignancy and chemotherapy both cause     accelerated loss of muscle mass, deconditioning, frailty and negative outcomes. Several     studies showed that chemotherapy accelerates ageing.      Muscle mass reserve was found to be a major predictor of outcomes in patients treated with     chemotherapy. Recently, several studies suggest that active muscle strength training during     chemotherapy may decrease side effects, improves the ability to deliver intended doses of     treatment and may even affect oncological outcomes.      In the proposed study we intend to assess the contribution of physical training to the     well-being of chemotherapy treated older patients, assessed by molecular and physiological     parameters.      We intend to recruit lymphoma patients above age of 70 and prospectively and randomly assign     them to the intervention group (strength, aerobic and balance training during the     chemotherapy) and control group (standard care with no special emphasis on physical activity     during the treatment).      We will measure clinical outcomes such as treatment tolerance and effects as well as     physiological outcomes (muscle strength and mass, elements activities of daily living) and     laboratory markers of ageing such as DNA methylation, INK 4a expression, telomere length and     serum levels of inteleukin 6, CRP among others.      Our hypothesis is that physical training will improve patients' ability to complete the     treatment with fewer side effects, will provide them with better daily functioning and better     muscle strength/function. We also hypothesize that the ageing process, as shown by laboratory     senescence markers, will be attenuated in the intervention group.   "
14156|NCT03100162|"     Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora     and intestinal epithelial permeability, mineral content and lifestyle in obese women with     postmenopausal metabolic syndrome: double-blind, randomized clinical trial.   "
14158|NCT03100136|"     This is a study measuring the binding kinetics and test-retest characteristics of a     subpharmacological dose of [11C]PF-06809247 Monoacylglycerol lipase (MAGL) Positron Emission     Tomography (PET) tracer in healthy adult subjects.   "
14159|NCT03100123|"     The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized     controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late     (≥10 weeks gestation) or recurrent early (2 <10 weeks) pregnancy loss will be recruited.      Eligible and consenting subjects will be assigned to one of two study arms: open-label     low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin     (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until     delivery.   "
14171|NCT03099967|"     To examine retrospectively whether transcatheter closure of the interatrial septum leads to     myocardial injury and to determine the mechanism.   "
14172|NCT03099954|"     Measure pulse wave velocity stability in relation to time of day, day of the week, physical     activity, sleep quality, stress levels and blood pressure.   "
14194|NCT03099668|"     A randomised study of multidisciplinary care (MDT) versus routine care in patients with     rheumatoid arthritis (RA). Patients with RA are randomised either to a single visit to a one     Stop Arthritis Clinic' (OSAC) or to see their usual rheumatologists. Data are collected at     the baseline visit, and again at subsequent clinic visits (approximately 3 and 6 months).     Outcomes such as quality of life, disease activity, physical function, disease specific     knowledge, coping and self efficacy are evaluated. Assessment of comorbidities and     preventative care (cancer screening, vaccinations, cardiovascular risk assessment and     optimisation) are also assessed between the 2 arms.   "
14195|NCT03099655|"     The purpose of this clinical study is to evaluate the safety and efficacy of the Attain     Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).   "
14160|NCT03100110|"     Individuals suffering from tetraplegia as a result of cervical spinal cord injury, brainstem     stroke, or amyotrophic lateral sclerosis (ALS) cannot independently perform tasks of daily     living. In many cases, these conditions do not have effective therapies and the only     intervention is the provision of assistive devices to increase independence and quality of     life. However, currently available devices suffer from usability issues and are limiting for     both the patient and caregiver. One of the most progressive alternative strategies for     assistive devices is the use of brain-computer interface (BCI) technology to translate     intention signals directly from sensors in the brain into computer or device action.     Preclinical primate research and recent human clinical pilot studies have demonstrated     success in restoring function to disabled individuals using sensors implanted directly in     motor regions of the brain. Other preclinical primate research has demonstrated effective     intention translation from sensors implemented in cognitive regions of the brain and that     this information complements information from the motor regions. The current proposal seeks     to build on these studies and to test the safety aspects related to implanting two sensors,     each a microelectrode array, into both the motor and cognitive regions of the brain in motor     impaired humans. Secondary objectives include feasibility evaluation of the complementary     sensors in their ability to support effective assistive communication.   "
14161|NCT03100097|"     The objective of this study is to evaluate sixty male and non-pregnant female patients     diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30     days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar     sacral orthosis (LSO) as a treatment modality for acute low back pain.   "
14162|NCT03100084|"     The PREPPeD study proposes that predelivery placenta-derived maternal circulating biomarkers     reflect placental health, capacity and ageing, and can help predict onset and complications     of delivery both in complicated pregnancies as well as in clinically uncomplicated     term/post-term pregnancies.   "
14163|NCT03100071|"     Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will     be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.   "
14164|NCT03100058|"     This is a dose-finding study to evaluate the change in weight after 24 weeks treatment with 8     different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24     weeks treatment with 2 doses of LIK066 and placebo.   "
49655|NCT02635698|"     Compare percent change in loss of body weight between the OPTIFAST program and a food-based     energy-deficit program   "
14167|NCT03100019|"     Objectives: Resveratrol, a non-flavonoid polyphenol, has been found to consistently modulate     cerebral blood flow (CBF) following oral supplementation. Although, this has not resulted in     subsequent predicted benefits to cognitive performance in young healthy populations. However,     it is argued that those who suffer a reduction in CBF and cognition, such as aging     populations, may benefit more from resveratrol administration.      Hypothesis: The current investigation aimed to employ a mild hypoxia as an experimental model     of aging in a young healthy population, to assess if resveratrol can attenuate the deficits     elicited by the reduction in oxygen supply. It was hypothesized resveratrol would module CBF,     to provide a more efficient supply of oxygen to overcome any associated decreases to     performance caused by the hypoxic model.      Design: This repeated measures, double blind, placebo controlled, balanced design assessed     the cognitive and CBF effects of resveratrol in hypoxia (equivalent to ~2000m above sea     level) and normoxia (sea level).      Methods: 24 participants arrived fully fasted (except water) for 12 hrs before completing a     baseline measure of a cognitive task battery, and taking the treatment for the day. Following     a 45 min absorption period, participants completed 3 full repetitions of the cognitive test     battery and, if appropriate, the oxygen level was altered. Changes in CBF were measured by     near-infrared spectroscopy throughout the full testing session.   "
14168|NCT03100006|"     The purpose of this study is to characterize the safety and tolerability, identify a     recommended dose for expansion (RDE) / recommended phase II dose (RP2D), pharmacodynamics,     and antitumor activity of Oregovomab vaccination in combination with Nivolumab as a novel     combinatorial immunotherapeutic strategy in in female patients with recurrent epithelial     ovarian cancer (EOC) who progressed after two or more prior lines of cytotoxic chemotherapy.   "
14169|NCT03099993|"     In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain,     before, during, or shortly after birth. These non-progressive lesions cause muscle     impairments, responsible for activity limitations. These muscle impairments include muscle     stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on     only one side of the body. To compensate for activity limitations with their impaired arm,     these children over-use their non-impaired arm. The objective of constraint-induced therapy     (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by     forcing the child to only use its impaired arm several hours a day during several weeks of     therapy. It is known using clinical tests that this therapy improves the overall motor     function of the impaired arm. However, the underlying mechanisms are yet unknown. An     understanding of these mechanisms would suggest ways to maximize the effectiveness of this     therapy, which requires a significant commitment from the child and its family. The     investigaors propose in this project a quantitative and objective evaluation of the effect of     CIT on the movements of the impaired arm of children with UCP. The investogators focus their     analysis on muscle activation, to assess which aspect of muscle impairments is modified by     CIT. To this end, the investigators will use sensors identical to those already used in     clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the     Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait     disorders. Results from this study will provide leads to optimize CIT. Some children could     for example benefit from CIT paired with treatments to reduce muscle stiffness or to     strengthen muscles   "
14170|NCT03099980|"     This is a pilot study in which the the safety and feasibility of secukinumab in HS patients     as well as information about the effect size will be determined in order to inform a future     larger randomized control trial with an active comparator.   "
14173|NCT03099941|"     Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus     muscles is the most important cause of the chronic nonspecific low back pain (CNLBP).     Recently, applications sre developed that generates audio and vibrant stimuli in response to     anteroposterior and mediolateral rotations and can be adapted according to subject-specific     movement sensitivity.      Objective. The objective of this study was to compare effects of a biofeedback application     that is alternative to physiotherapist feedback in core stabilization training of patients     with chronic nonspecific low back pain.      Design. This study was a parallel group randomized controlled trial with outcome assessment.      Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back     pain.      Interventions. Patients were randomly assigned to receive either physiotherapist feedback or     Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12     sessions, 30 minutes of three weekly graded functional core education trial.      Measurements. Primary outcome measures were muscle strength (transversus abdominus and     multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry     Disability Index); secondary outcomes were flexibility (modified Schober test), range of     motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear     Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality     of life(36 Item Short-Form Health Survey questionnaire [SF-36]).      Limitations. Outcome measures for muscle strength did not include objective assesment.      Keywords. Chronic low back, core stabilization training, biofeedback, pain, function   "
14174|NCT03099928|"     Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits     in positive affect and associated barriers to completing health behaviors in type 2 DM     patients.      Hypothesis: Patients will be able to complete the structured interview, providing information     about their own positive emotional states, identifying strategies to enhance positive     emotions, linking the presence of positive emotions to better adherence to health-related     behaviors, and identifying additional barriers to completing such behaviors.      Specific Aim #2 (Creation of intervention): To use the data gathered from qualitative and     quantitative measures to create a positive psychology-based intervention      Hypothesis: Using the information provided in this trial, the investigators will be able to     create an intervention, composed of several positive psychology exercises, that is     well-matched with a diabetic population and is targeted to the enhancement adherence to     health-related behaviors in this population. This intervention will then be ready for next     stage testing.   "
14223|NCT03099291|"     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in     RSV-seronegative infants and children 6 to 24 months of age.      This study is a companion study to IMPAACT 2013.   "
14175|NCT03099915|"     Objective: Identify modifiable factors that may affect asthma control and the use of     emergency room to define customized interventions for the management of asthma prior to     emergency room.      Emergency department attendance is always a sign of poor balance or control of asthma. In     spite of a decrease in the number of deaths that has been halved in 20 years and     hospitalization due to asthmatic disease, the use of emergency center for this disease has     not decreased. We now know that the passage through emergencies and hospitalization for     aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor     balance or control of asthma is essential to further reduce the mortality and morbidity of     asthma.   "
14176|NCT03099902|"     This study will investigate the interaction between GSTP1 / TNFa polymorphisms and passive     smoking in children with asthma/wheezing. Contemporary second hand-smoke exposure will be     confirmed by laboratory testing.   "
14177|NCT03099889|"     The WHISH-2-Prevent Heart Failure (HF) study is an ancillary study to the Women's Health     Initiative Strong and Healthy (WHISH) exercise pragmatic trial. The WHISH-2-Prevent HF trial     examines the intervention effect of physical activity (PA) on both incident HF and HF burden     (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In     addition, it will allow a dose-finding analysis to better understand the type, intensity and     frequency of PA that leads to a reduced risk and burden of HF. The focus of the parent WHISH     trial is on atherosclerotic cardiovascular disease and not heart failure.   "
14178|NCT03099876|"     This study compared efficacy and safety of basic triple therapy according to treatment     period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy   "
14179|NCT03099863|"     Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective     gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative     antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic     medical therapies have been utilized to attempt to decrease this rate with little     improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease     postoperative UTIs. The investigators have designed a prospective randomized controlled study     to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative     urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.   "
14180|NCT03099850|"     The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible     for the coordination and data management for the Prospective Evaluation of Chronic     Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of     the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic     Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur     at external sites that are a part of the CPDPC. The data management systems, auditing, and     monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support     Center (CRSC).   "
14181|NCT03099837|"     This is a population-based study to obtain data for the evaluation of current used     recommendations for weight gain during pregnancy released by IOM (2007) and investigate the     association between maternal diet and the health outcomes of mother and offspring.   "
14182|NCT03099824|"     The purpose of the phase 1, GTO-003 clinical study is to determine the safety, tolerability     and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral     tablet. This study will compare capsules containing a liquid suspension of GC4711 when given     orally to a similar drug called GC4419 which will be given as an intravenous infusion. This     study will also assess the effect of food on GC4711.   "
14196|NCT03099642|"     The aim of this study is to determine if emergency physician performed ultrasound-assisted     lumbar puncture improves first-time success rates in a pediatric population. This will be     done by comparison with current landmark-based approach to the procedure.   "
14184|NCT03099798|"     OBJECTIVE:      To determine the quality of life (QOL) and clinical outcome after conservative therapy,     embolization (proximal versus distal) or surgery in patients with traumatic splenic injury.     Secondary aims: (I) to examine therapy-related complications, (II) to establish the necessity     of additional therapies, (III) the assessment of splenic function related to splenic     morphology (MR imaging) after embolization and (IV) to find the prognostic factors for     failure of non-operative management (NOM) in patients with splenic injuries. Finally, with     the acquired data from this study a patient-oriented protocol will be provided for the     management of traumatic splenic injury.      HYPOTHESIS:      The investigators expect that NOM is superior to surgery with regard to QOL, clinical outcome     and splenic function. Embolization will need more additional therapies. Splenic morphology is     related to splenic immune function. Expected prognostic factors are age above 40, ISS >25 and     a splenic injury grade of 3 or higher.      STUDY DESIGN:      A combination of a retrospective and a prospective multicentre cohort study. This protocol     involves the prospective part of the study.      STUDY POPULATION/DATASET:      Patients who enter the participating hospitals between March 2017 and July 2018 with splenic     injury will be asked to participate. The follow-up period will be one year with regard to     QOL, clinical symptoms and imaging.      INTERVENTION:      All patients will complete a number of questionnaires at different time points. The patients     who were treated with splenic artery embolization (SAE) will undergo an MRI one month and one     year after treatment.      OUTCOME MEASURES:      Primary outcome is QOL. Secondary outcomes are clinical symptoms and imaging.      SAMPLE SIZE:      Approximately 100 patients will be included per year during the inclusion phase.      DATA ANALYSIS:      With regard to the prospective data linear modelling will be performed.      COLLABORATION/CONNECTION:      Tilburg University, Erasmus medical center Rotterdam, Maasstad hospital Rotterdam, Albert     Schweitzer hospital Dordrecht, Amphia hospital Breda.      TIME SCHEDULE:      Year 1: literature search and conducting the retrospective study and analyses. Years 1-3:     inclusion prospective study and follow-up of patients. Year 4: finishing follow-up data     collection and analysing.   "
14185|NCT03099785|"     The objective of this study is to evaluate the safety and efficacy Rifamycin SV-MMX® 600 mg     tablets for patients with diarrhoea-predominant irritable bowel syndrome when administered     two to three times daily.   "
14202|NCT03099564|"     This is an open-label multi-center trial designed to evaluate the efficacy as well as the     safety of combining pembrolizumab with Yttrium-90 (Y90) radioembolization in subjects with     poor prognosis (high risk) HCC not eligible for liver transplant or surgical resection with     well compensated liver function. Treatment will consist of pembrolizumab 200mg IV every 3     weeks in conjunction with Y90 radioembolization performed one week after the first dose of     pembrolizumab. If bilobar disease is present, a second Y90 radioembolization will be     performed no later than 4 weeks after the first procedure to the contralateral hepatic lobe.   "
14203|NCT03099551|"     The aim of the present study was to evaluate the efficacy of two different toothbrushes     (manual and sonic) on plaque control   "
14204|NCT03099538|"     Recently, Interleukin (IL)-17 has been identified as a key driver of chronic inflammation in     Bullous Pemphigoid (BP). Ixekizumab is a recombinant high-affinity fully human monoclonal     antibody that targets IL-17A Immunoglobulin gamma-1 (IgG1)/kappa-class. The purpose of this     study is to determine the effect of Ixekizumab on BP patients.   "
14186|NCT03099772|"     Generalized anxiety disorder (GAD) is a condition characterized by chronic and excessive     worry and anxiety. Over the past 15 years, the investigators have developed a     cognitive-behavioural treatment that leads to the remission of GAD in approximately 60% to     75% of affected individuals. Although these numbers are encouraging, there remain a     considerable proportion of patients who do not fully benefit from treatment. With the goal of     improving treatment efficacy, the investigators have recently carried out a series of related     studies on the way individuals with GAD and high worriers process uncertain or ambiguous     information from their environment. The findings show that these individuals display biases     in attention for, and appraisal of, uncertain or ambiguous information. Specifically,     individuals with GAD and high worriers preferentially allocate their attention to     uncertainty-related stimuli and appraise ambiguous information in a threatening manner. In     this study, the investigators examine the impact of these information processing biases,     measured at intake, on the efficacy of cognitive-behavioural treatment for GAD. The     investigators also examine the impact of residual information processing biases, measured at     posttreatment, on the maintenance of treatment gains over 18 months following treatment. The     main hypotheses are (1) that high levels of pretreatment biases will predict poorer outcomes     immediately following therapy, and (2) that high levels of posttreatment biases will predict     relapse during the 18 months following therapy. If, as expected, information processing     biases predict poor short- and long-term treatment outcomes for individuals with GAD, the     investigators will expand the treatment to integrate strategies that directly target these     biases in order to increase its efficacy.   "
14187|NCT03099759|"     Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different     dosing groups and how their levels change over a 3 month period of time.   "
14188|NCT03099746|"     Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than     half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life     care.This is particularly the case for patients with chronic critical illness, a     life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have     transient or persistent cognitive impairment that precludes them from making their own     healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest     risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a     family member. SDMs for the critically ill often describe high states of psychological stress     associated with the uncertainty of the patient's condition and their decision making role.      The purpose of this study is to test the effectiveness of two decision support interventions     for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test     interventions tailored to the unique needs of the SDMs of CCI patients delivered using an     interactive avatar based format.   "
14189|NCT03099733|"     This will be a prospective study of the implementation of a real-time assessment and     intervention of a text messaging tool in mild traumatic brain injury (mTBI) patients     post-discharge from the emergency department.   "
14190|NCT03099720|"     Following a hysterectomy, women tend to experience high levels of pain, and many require     strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable     numbing medication) which works by blocking pain signals. The aim of this study is to find     out whether injections of ropivacaine during surgery can help provide effective pain relief     after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can     participate in the trial. Participants are randomly allocated to one of two groups. Those in     the first group are given injections of ropivacaine at the site of the wound and in the     peritoneum (space in the body that holds the organs in the abdomen) and those in the second     group are given injections of a saline fluid in the same places that offers no pain relief     before the end of their surgery. Participants in both groups are then regularly asked to rate     their pain levels up to 24 hours after surgery. In addition, the pain killers they receive     and length of hospital stay are recorded. There is a chance that the participants who receive     the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks     of participating.   "
14191|NCT03099707|"     This study will evaluate the feasibility and acceptability of the Treatment Ambassador     program - a peer-supported intervention targeting individuals living with HIV who have not     started on treatment within at least 3 months of testing.   "
14192|NCT03099694|"     The investigators compared advantages and disadvantages of two forms of noninvasive     respiratory support —noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal     continuous positive airway pressure (nCPAP) —as a primary mode of ventilation in premature     infants with RDS．   "
14193|NCT03099681|"     Prospective Italian study aimed to provide a description of the population affected by     Epithelioid Sarcoma (ES)   "
14198|NCT03099616|"     Complete recovery from anaesthesia is absolutely desirable in the obese patients to avoid     postoperative airway, oxygen ventilation or sleep apnea related complications. Over the     years, Desflurane has emerged as the anaesthetic agent of choice for maintenance of     anaesthesia in obese patients for its efficient elimination profile and ability to facilitate     early recovery from anaesthesia. Alternatively, Propofol is a commonly used intravenous     anesthetic agent administered as a part of total intravenous anesthesia (TIVA) regimen.     However, it is a lipid soluble drug and there are concerns that it may accumulate in obese     patients due to their increased proportion of body fat Therefore, Propofol TIVA is likely to     result in a prolonged duration of action and consequently, delayed emergence from anaesthesia     and a protracted recovery time. A recent advance in the delivery of Propofol to the patient     is the development of computer-controlled anesthesia delivery systems. These devices deliver     Propofol based on feedback from patient's frontal cortex electrical activity as determined by     monitoring bispectral index (BIS). Evaluation of anesthesia delivery by these systems has     shown that Propofol and maintain depth of anesthesia with far more precision as compared to     manual/simple infusion administration. This, in turn, holds promise that recovery from     Propofol anaesthesia can also be favourable in the obese patients. An indigenously developed     computer-controlled anesthesia delivery sytem is the closed loop anaesthesia delivery system     (CLADS), which has been extensively evaluated in patients belonging to different surgical     settings. The evidence generated with Propofol anaesthesia delivered by CLADS has shown     significant improvement in recovery outcome.The performance of CLADS has not yet been     evaluated in obese surgical patients. We hypothesise that in the obese patients undergoing     bariatric surgery, automated delivery of Propofol using CLADS would allow precision control     of anaesthesia depth, intra-operative haemodynamics, and rapid recovery from anaesthesia. We     plan to conduct a randomised controlled investigation to compare patient recovery profile     following Desflurane anaesthesia versus CLADS empowered Propofol anaesthesia.   "
14199|NCT03099603|"     This is a randomized, double blind, single center, ascending single dose study to evaluate     the safety, tolerability, and PK of HTD1801.   "
14200|NCT03099590|"     Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4     weeks of follow-up) investigating the impact that Alkontrol-herbal (Isoflavone; Kudzu) has on     alcohol intake in a population seeking treatment for an alcohol use disorder.   "
14207|NCT03099499|"     ONC201 is a small molecule which selectively targets the G protein-coupled receptor DRD2.     Downstream of target engagement, ONC201 activates the integrated stress response (ISR) in     tumor cell leading to inactivation of Akt and extracellular signal-regulated kinase (ERK)     signaling as well as induction of the TRAIL pathway. ONC201 also inhibits dopamine receptor 2     (DRD2), resulting in anti-tumor responses in preclinical models. Single agent ONC201 has been     examined in open-label Phase I studies in patients with advanced, treatment refractory solid     malignancies. Due to its differential anti-proliferative and pro-apoptotic response in tumor     cells, treatment was overall well tolerated, and the recommended phase II dose of ONC201 was     set at 625mg every three weeks. An additional dose-escalation phase I study (NCT02609230) is     further evaluating weekly versus three week dosing in patients with advanced solid tumors and     multiple myeloma. Preliminary data from these phase I studies suggests a possible clinical     benefit in patients with advanced, chemo-refractory endometrial cancers, with at least one     mixed response noted in a patient with clear cell histology.      Hypothesis: Single agent ONC201 will demonstrate clinical benefit in women with recurrent or     metastatic endometrial cancers, especially in those women with alterations in the     Phosphoinositide 3 kinase (PI3K)/Akt/mammalian target of Rapamycin (mTOR) pathway.   "
14208|NCT03099486|"     This is a single arm open label pilot phase II trial of Regorafenib PO plus 5-FU/LV infusion     in 15 mCRC patients who progressed on prior Regorafenib monotherapy as well as 5-FU     containing chemotherapy combinations.The study will enroll mCRC patients with prior     progression on standard multi-agent combination chemotherapy and progression on regorafenib     monotherapy.   "
14209|NCT03099473|"     The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with     ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these     two interventions.   "
14210|NCT03099460|"     The purpose of the study is to testify the efficacy of treating abducens nerve palsy with     ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these     two interventions.   "
14211|NCT03099447|"     The purpose of the study is to testify the efficacy of treating oculomotor nerve palsy with     ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these     two interventions.   "
14212|NCT03099434|"     This pilot study will be a clinical trial to test the feasibility and effectiveness of an     educational intervention and a mobile health intervention in adults with end stage renal     disease (ESRD) who have not yet identified a potential live donor.   "
14213|NCT03099421|"     The aim of this study is to investigate the safety and efficacy of prostatic artery     embolization (PAE) for patients who refuse or are not eligible for surgery with     moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign     prostate obstruction due to benign prostatic hyperplasia.   "
14215|NCT03099395|"     Recurrent myocardial infarctions (reinfarctions) can be due to recurrence at the original     treatment site, the presence of untreated lesions elsewhere, or in progressive lesions. There     are scarce published data describing the localization (affected vessel/s) and severity     (NSTE-ACS/STE-ACS) of reinfarction(s) compared to the index MI (e.g proportion of recurrent     infarctions in the previously diseased vessel) in large unselected patient populations. If     reinfarctions are generally more severe than index MI/recurrent MI(s), this might have     implications for choice of treatment and treatment length.      Moreover, data from unselected patient populations on the overall incidence pattern/rate of     patients experiencing multiple reinfarctions is sparse. Patients who experience multiple     ischemic events may be a subset of patients who are poor responders to therapy. There is also     a possibility that patients with multiple events are less likely to have received     evidence-based therapy such as coronary stenting, novel and more effective antithrombotics     and modern lipid lowering treatment for the initial event. Poor adherence to secondary     prevention measures (e.g. low compliance to medication and adherence to cardiac     rehabilitation programs) may also increase the risk of recurrent events.      Therefore identification of the baseline characteristics, including treatment decision     strategies in the setting of a myocardial infarction, among such subjects may allow     modifications of the clinical management strategy prior to the occurrence of subsequent     ischemic events. Such modifications could include providing a more intensive or additional     therapy in certain patient groups or find strategies to improve patient adherence and drug     compliance.      A patient with reinfarctions requires more hospitalizations, treatments, laboratory tests,     and out-patient visits, resulting in overall increased costs. From the patient perspective,     recurrent events result in higher mortality and worsened quality of life.   "
14216|NCT03099382|"     In this study, participants with advanced or metastatic squamous cell carcinoma of the     esophagus that has progressed after first-line standard therapy will be randomized to receive     either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel     or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong     overall survival (OS) as compared to treatment with standard therapy.   "
14217|NCT03099369|"     Peripheral artery disease (PAD) is caused by blockages in the leg arteries. PAD limits     patients' walking ability and quality of life. For patients with PAD, home exercise programs     can improve walking ability and quality of life. In many patient populations, walking more     than 5,000 steps a day is associated with better health. Currently, the benefit of walking     more than 5,000 steps a day in patients with PAD has not been well studied.      The purpose of this clinical trial is to compare two different home exercise programs in     patients with PAD: walking at least 5,000 steps a day with the help of fitness monitors vs.     walking 45 consecutive minutes for 3 to 5 days a week (a common exercise prescription for     PAD). This study has the potential to demonstrate that, with the help of fitness monitors,     walking at least 5,000 steps a day can improve walking ability and quality of life for     patients with PAD.   "
14218|NCT03099356|"     This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the     treatment of metastatic differentiated thyroid cancer. Patients will be treated with     Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19.     Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo     imaging to evaluate efficacy once every 2 cycles.   "
14219|NCT03099343|"     The proposed study will determine the effectiveness of a mobile application location-based     tailored notification message system in helping hypertensive patients reduce dietary sodium     intake and feel more confident in following a low sodium diet.   "
14220|NCT03099330|"     To study the pharmacokinetic characteristics of TQ-B3139 in the human body, recommend a     reasonable regimen for subsequent research.   "
14221|NCT03099317|"     The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and     improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters     University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG) and 8-step Stair Climb Test     (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham     acupuncture controlled, patient and assessor blinded, pilot study will be employed.   "
14224|NCT03099278|"     Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and     HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy     with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to     evaluate the utility of Ezetimibe in patients with chronic HDV infection   "
14225|NCT03099265|"     Surgical resection is the only potentially curative treatment for patients with pancreatic     cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the     extent that resection is prohibited. Nonetheless, retrospective studies have shown that     immediate resection in these patients is associated with an increased risk of positive     margins, and a margin positive resection does not improve survival over that of patients with     unresectable disease. Moreover, even in those patients where a successful resection is     achieved, there is a high rate of early metastatic progression suggesting that     micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is     likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a     margin negative resection, provide early control of occult micrometastatic disease, and     select those patients without systemic progression who would benefit from surgical resection.   "
14226|NCT03099252|"     Newborn infants have blood work procedures for newborn screening and bilirubin testing in     their first days of life that cause pain, distress and physiological changes. Breastfeeding     (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or     glucose) with or without a pacifier, effectively and safely reduce pain and distress in     newborn infants during painful procedures. However, studies of neonatal pain management     practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies.     There is a clear need for developing and testing acceptable parent-targeted interventions,     alongside health care provider-targeted knowledge translation (KT) interventions, to support     parents' involvement in comforting their infants during painful procedures. To address this     knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the     BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during     infant bloodwork and how parents can use and advocate for these pain management strategies.      This study will evaluate the effectiveness of a parent-targeted and mediated KT strategy, the     BSweet2Babies video, when shown to parents of newborns prior to newborn screening or     bilirubin testing, on subsequent use of the three pain reduction strategies during the blood     test.      The target sample size for the study is 20 hospitals. Following consent, hospitals will be     randomized to one of two groups: the intervention group (showing parents the BSweet2Babies     video prior to their baby's newborn screening blood test) or the control group (no education     or information provided). Hospitals in the intervention group will show all parents the 5     minute BSweet2Babies video before newborn bloodwork. BORN Information System (BIS) data will     subsequently be analyzed to evaluate the use of BF, SSC and sweet solutions.      The investigators hypothesize that hospitals randomized to the BSweet2Babies video will have     a higher rate of use of BF, SSC or sucrose as measured by the systematically collected Better     Outcomes Registry & Network (BORN) Ontario pain data elements during newborn screening or     bilirubin testing, compared to hospitals randomized to usual Health Care Provider     (HCP)-targeted education.   "
14229|NCT03099213|"     Primary Objective:      To document the tolerability of patients receiving study medication at 12-week of therapy in     terms of the scoring system assessed by the investigator.      Secondary Objectives:        -  To document drug safety at 12-week of treatment in terms of number of Adverse Drug          Reaction or Serious Adverse Drug Reaction reported.        -  To describe the population treated as per the HOPE study indication in current clinical          practice (demographics, cardiovascular risk-factors at treatment initiation, concomitant          treatments patterns).   "
14230|NCT03099200|"     The purpose of this study is to compare productivity (in terms of work or daily activity) and     generic and disease-specific health-related quality of life of participants with HER2     positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or     targeted HER2 therapy), with participants who have completed adjuvant parenteral therapy, and     participants with HER2 positive metastatic breast cancer.   "
14231|NCT03099187|"     The purpose of this study is to evaluate the efficacy and safety of pirfenidone in     participants with fibrosing interstitial lung disease (ILD) who cannot be classified with     moderate or high confidence into any other category of fibrosing ILD by multidisciplinary     team (MDT) review (unclassifiable ILD).   "
14232|NCT03099174|"     For each dose finding cohorts (A, B, C and D):      The primary objective of each dose finding cohort is to determine the maximum tolerated dose     (MTD) / recommended phase II dose (RP2D) of xentuzumab in combination with abemaciclib with     or without hormonal therapy (letrozole, anastrozole, fulvestrant). Dose limiting toxicities     (DLT) will be assessed during the first treatment cycle to assess the MTD/RP2D.      In case that no MTD is reached a RP2D dose will be determined taking into account safety data     and other available information. This will be agreed with the Steering Committee.      For each expansion cohorts (E and F):      The objectives of the expansion cohorts are to assess the anti-tumour activity of xentuzumab     in combination with abemaciclib in patients with non-small cell lung cancer (cohort E).      Tentatively a cohort F may be opened to assess the anti-tumour activity of the triplet     combination xentuzumab / abemaciclib and fulvestrant in a single-arm expansion group of     patients with locally advanced / metastatic hormone receptor positive (HR+) breast cancer who     have progressed following prior aromatase inhibitor therapy and prior CDK4/6 inhibitor     treatment. Cohort F will only be opened if indicated by emerging data from ongoing clinical     trials.   "
14233|NCT03099161|"     The purpose of this study is to evaluate the safety and preliminary efficacy of preladenant     alone and in combination with pembrolizumab (pembro) in participants with advanced solid     tumors that have not responded to prior therapy. This study will be done in 2 parts. Part 1     will identify and confirm the recommended Phase II dose (RP2D) of preladenant when given     alone or in combination with pembrolizumab. Part 2 of the study will determine the safety and     efficacy of preladenant in combination with pembrolizumab at the RP2D in participants with     select solid tumors .   "
14234|NCT03099148|"     The purposes of this study are to determine:        -  If there are any differences in the amount of LY3337641 in the blood/body when it is          taken in different formulations. A total of 3 different formulations of LY3337641 are          being tested.        -  How a high-fat meal affects the amount of LY3337641 in the blood/body.        -  How safe and well tolerated LY3337641 is.      The study has four periods. Individuals will participate in all four periods. Each period     will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).      This study is expected to last up to 8 weeks. This includes the initial screening period, the     study or dosing period, and the follow up period.   "
14235|NCT03099135|"     The main purpose of this study is to evaluate the durability of Sustained virologic response     (SVR) in participants who achieved SVR at last post-therapy visit of parent studies (LPVPS)     with NCT Numbers NCT02569710 and NCT02765490.   "
14274|NCT03098628|"     This is a single-blind, open-label, randomised controlled trial with five groups. There are     four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.   "
14236|NCT03099122|"     Primary Objective:      To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for     preventing acute rejection (AR) after transplantation among recipients of Donated after     Cardiac Death (DCD) kidney transplant.      Secondary Objectives:        -  To evaluate delayed graft function (DGF), graft and patient survival after kidney          transplant.        -  To evaluate adverse events of Thymoglobuline® throughout the study.        -  To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.        -  To evaluate AR and DGF under different risk stratifications and explore an description          optimal induction therapy regimen for recipients of DCD kidney transplant.   "
14237|NCT03099109|"     The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an     anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody     administered alone or in combination with LY3300054, an anti-programmed death ligand 1     (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.   "
14238|NCT03099096|"     This study is aimed to assess the correct real-world use of an autoinjector for the repeat     self-administration of mepolizumab SC, so to improve subject / physician convenience and to     enable repeat dose self injection themselves or via caregivers. This Phase III study will be     an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product     in autoinjector (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3     doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab     SC as a single injection that is self-administered in the thigh, abdomen or administered in     the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks     including pre-screening visit, a screening visit and a 12-week treatment period which     concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab.     Approximately 158 subjects will be enrolled in the study.   "
14239|NCT03099083|"     The objective of this non-interventional, observational study is to assess the effect of     adalimumab on health-related quality of life in participants with Psoriasis in Korea.   "
14240|NCT03099070|"     This study will examine the influence of stress and fasting on headache activity.     Participants will receive both a control and stress session and be randomized to either     fasting or not fasting for the visits.   "
14241|NCT03099057|"     Develop a prospective register assessing the short- and long-term complications of patients     undergoing interventional rhythm   "
14242|NCT03099044|"     The purpose of this pilot study is to determine the effects of a Single and Double Dose of     Fermented Dairy Beverage on immune health and inflammatory status in healthy adults     undergoing stressful exercise.   "
14244|NCT03099018|"     Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic     challenge in pediatric emergency departments, since isolated signs and clinical prediction     rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid     antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing     for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity     is not optimal. The aim of the present study is to test the accuracy of a new fluorescent     immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children     3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the     gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).   "
14245|NCT03099005|"     Acute cannabis administration is reported to alleviate HIV neuropathic pain (HIV-NP), but     there is limited knowledge about the effects of cannabis constituents (delta-9     tetrahydrocannabinol/THC and cannabidiol/CBD), the consequences of long-term cannabis use,     and the impact of cannabis on endocannabinoid (EC) function in people living with HIV- NP.     Our objective is to address these three fundamental gaps in our knowledge by: 1) examining     the acute effects of various CBD/THC products on HIV-NP, 2) utilizing a mHealth text     messaging protocol, Individual Monitoring of Pain and Cannabis Taken (IMPACT) to monitor     daily real-world cannabis use and changes in pain; and 3) studying the relationship between     cannabinoids, EC biomarkers, and chronic neuropathic pain   "
14246|NCT03098992|"     There are many existing treatments of female stress urinary incontinence such as the use of     adult absorbent pads and diapers, behavioral training, including bladder training, pelvic     muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical     stimulation, periurethral injections, and reconstructive surgery. However, there is still a     lack of effective minimally invasive treatment options that are independent of patient     compliance.      One emerging approach of minimally invasive SUI therapy is pelvic floor reinforcement using     laser therapy.      The primary objective of this post-marketing study is to confirm the effectiveness and safety     of the FotonaSmooth® device in the treatment of stress urinary incontinence (SUI) in a large     number of females using objective and subjective methods.      Patients with stress incontinence will be assigned to two groups, an active group, where the     Fotona Dynamis Er:YAG Laser System will be used, and a sham group where a very low laser     setting will be used, and parameter presentations will be masked.      Participants will be adult females, 18 years old and older with clinical and urodynamic     diagnosis of Stress Urinary Incontinence,who have had no significant improvement in urinary     incontinence from at least one previous conservative treatment, such as behavioral measures,     pelvic floor muscle training or the use of absorbent pads   "
14247|NCT03098979|"     The objective of the study is to find the optimal dose of once daily oral neladenoson     bialanate (BAY1067197) when given in addition to appropriate therapy for specific     comorbidities.   "
14248|NCT03098966|"     The purpose of the study to evaluate the practice and short term maternal and perinatal     outcomes of trial of labor after cesarean section offered to women at Ain Shams University     Maternity Hospital (ASUMH) during the 3-year period from January 2013 to December 2015.   "
14249|NCT03098953|"     Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat     Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel   "
14250|NCT03098940|"     This study is a two part study   "
14251|NCT03098927|"     The overall vision of this proposal is to demonstrate that a virtual reality based motor     imagery training program will improve brain computer interface (BCI) performance and motor     function in quadriplegic subjects. The ultimate goal is to increase the independence of     subjects with spinal cord injury by training to safely control BCI assistive devices and to     enhance motor recovery.   "
14252|NCT03098914|"     Community-Acquired Pneumonia has become common. Additionally, the mortality is high. But the     epidemiology of pathogen is various in different areas, which is crucial for the key     treatment. In addition, the risk factors of patients who died in 3 or 7 days in china is not     clear, comparing with patients who died in 14 or 28 days or who survived.   "
14253|NCT03098901|"     Cardiac amyloidosis is a multi-organ syndrome, which usually presents as restrictive     cardiomyopathy (RCM). Transthyretin (TTR) amyloidosis (or ATTR) is a subtype of amyloidosis     which frequently involves heart. Cardiac ATTR, though infrequently diagnosed during lifetime,     may represent a prevalent cause of RCM, especially in elderly. Several medications that can     limit progression of the disease are currently under investigation. Presently the golden     standard for diagnosis of ATTR is endomyocardial biopsy (EMB) which may entail severe adverse     complications causing under-diagnosis of ATTR.      Several papers support the evidence that Tc99m-labeled tracers can be used to detect     myocardial deposits of TTR amyloid. It was suggested that Tc99m scintigraphy might be a     highly sensitive diagnostic tool for cardiac ATTR. In this study the patients with otherwise     unexplained cardiomyopathy or heart block will undergo Tc99m scan, which will establish the     incidence of this largely underdiagnosed condition in the population.   "
14254|NCT03098888|"     Little is known about bronchoalveolar lavages performed for cytological assessment during     bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual     contribution to diagnosis and therapeutic decision, and complications have not been     extensively assessed.      The primary objective of this multi center, prospective, observational study is to describe     the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill     patients, identify their indications, assess their contribution to diagnosis and therapeutic     decisions, and estimate the frequency of induced respiratory events.   "
14255|NCT03098875|"     Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane.     Induction and maintenance were standardized, and after the end of surgery, two steady-state     recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously     recorded and cardiac autonomic nervous activity was investigated using spectral analysis of     RR Interval variability   "
14305|NCT03098212|"     Pregnant women who eligible with inclusion criteria are random to two groups. Aromatherapy     group will receive the aromatherapy during labor along with standard pain control.      Non-aromatherapy group will receive standard pain control during labor   "
27475|NCT02926118|"     This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in     the interstitial fluid) during a dietary intervention using meals with either a high with a     low glycemic load.   "
14257|NCT03098849|"     The purpose of this study is to investigate the effects of a Buteyko-based breathing     technique on physiological and psychological parameters in adults with asthma   "
14258|NCT03098836|"     The primary goal is to prospectively estimate the median PFS of African American and     Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary     objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir,     and percent of men who achieve a PSA < 0.1; Radiographic assessments: to estimate the rate of     objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability,     particularly incidence and grade of hypertension in the two populations.      This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide     and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated     that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50     Caucasian) over a 24 month accrual period. The study agents will be administerd at the     following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once     daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period.      Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of     patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95%     confidence intervals based on the binomial distribution will be computed. In addition, post     therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product     limit method will be used to estimate the rPFS, biochemical PFS and overall survival     distributions.   "
14259|NCT03098823|"     To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as     measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).   "
14260|NCT03098810|"     Zinc supplementation effect on appetite and growth of malnourished children   "
14261|NCT03098797|"     A randomized double-blind cross over trial to evaluate the safety, efficacy and tolerability     of elamipretide in subjects with Barth Syndrome.   "
14262|NCT03098784|"     The goal of this study is to assess the respiratory health of the Air France company's     employees working in the Marseilles and Paris airports (flight line and administrative     employees). This study was promoted by the Montpellier CHRU, Regional University Hospital     Centre (ANSM identification number 2011-A00646-35). It allowes voluntary employees to be     involved. They answer a lifestyle survey and perform a spirometry, an exhaled CO measurement     and a sampling of exhaled air condensate (EAC). A metrological study of particles emitted by     aircraft engines and found in the airport environment will be conducted and the elementary     chemical composition analysis, as well a sieve analysis of particles present in the EAC will     be conducted.   "
14263|NCT03098771|"     To verify angiogenesis in elderly patients with atherosclerotic ischemia after peripheral     blood autologous CD34+ cell transplantation.   "
14264|NCT03098758|"     Gastric carcinoma is a disease with a high mortality. Peritoneal washing cytology has a     recognized prognostic utility. However sensibility of this study is not appropriate. Studies     with PCR (polymerase chain retrotranscription) can increase sensibility and accurate staging     information.      Objective: To analyze the sensibility and specificity of the expression of CK20, CEA and     Ber-EP4 with PCR technique in peritoneal washings of advanced gastric carcinoma without     clinical evidence of peritoneal carcinomatosis.      Methodology: Retrotranscription analysis (RT-PCR) and quantitative PCR (qPCR) of CK20, CEA     and Ber-EP4 in peritoneal washing. Test the feasibility of qPCR with this new marker     (Ber-EP4). Comparison of the results with data obtained with conventional cytology. Study of     peritoneal recurrence.   "
14265|NCT03098745|"     The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision     performance of three monthly replacement sphere lenses.   "
14266|NCT03098732|"     The objective of the MEDIS study is to determine if subjects experiencing an Acute Ischaemic     Stroke due to large vessel occlusion, treated with IV tPA combined with the MED procedure     have a greater likelihood of recanalisation 30-90 minutes after the completion of tPA     infusion than subjects treated with IV tPA (plus sham device). Safety of the MED System     Procedure will be evaluated by the incidence of symptomatic PH-2 haemorrhagic transformation     within 24 hours following the procedure. Lastly, a health economics study will be conducted     to estimate health care costs for each treatment.   "
14267|NCT03098719|"     GISMO combines spatial information with findings on the health effects of sustainable, active     forms of mobility in the work environment in order to derive evidence-based decision-making     bases for a health-promoting, operational mobility management. Existing approaches - with     regard to spatial information systems, decision-support systems and health effects of active     mobility - are considered and supplemented by our developments and investigations. Achieved     non-personal results are provided through standardized web interfaces, ensuring integration     into existing and prospective tools of an innovative and health-promoting mobility     management.   "
14357|NCT03097523|"     This is a feasibility study to determine optimal thigh cuff design using a cephalad fluid     shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir)     placed for the delivery of central nervous system chemotherapy or for diagnosing potential     elevation of ICP and monitoring its progression as part of standard medical care.   "
14268|NCT03098706|"     Each year, only one third of patients registered on the waiting list receive a kidney     transplant. Numerous paths are being explored with the aim of reversing this shortage. The     first is to increase the number of organs by developing harvesting from donors in a state of     brain-death (BD) termed expanded criteria donors or from patients deceased from circulatory     arrest.      Another fundamental factor is to insure the success of the transplant by limiting the     dysfunction of donor kidneys, marked by a delayed graft function (DFG).      The development of techniques to insure correct perfusion of harvested organs, and the     optimization of reanimation and intensive care of brain-dead donors constitute important     factors in DGF reduction.      Therapeutic Hypothermia could to be an attractive care strategy for BD patients.   "
14269|NCT03098693|"     This is a prospective observational study of couples in Kisarawe, Tanzania who will be     provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling     provided at the household, (2) linkage to a counseling and referral center for those who test     positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV     infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV     sero-discordant couple. We will identify HIV sero-discordant couples through the HIV     self-testing component, and through identifying discordant couples at the local HIV clinic.     HIV sero-discordant couples (N=60 couples) will be administered a baseline, 6- ,12-, and     18-month survey, and the investigators will collect ongoing clinical data from each clinic     visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with     the counseling and referral center, and HIV treatment center, to allow linking of utilization     of services with survey data.   "
14270|NCT03098680|"     Unwanted effects on the cardiovascular system is one of the most common causes of safety     related discontinuation of a drug. This study aims to develop an in silico model of the human     cardiovascular system that can be used to predict unwanted cardiovascular effects of drugs.     This will be achieved through a drug administration study that will generate comprehensive     pharmacokinetic and pharmacodynamic data following the administration of the following drugs,     all known to have effects on the cardiovascular system. Half the participants will receive:     Placebo, Salbutamol, Nicardipine, Dobutamine and the other half will receive Placebo,     Phenylephrine, Verapamil, Phentolamine.   "
14271|NCT03098667|"     The patients will be allocated to 2 groups: the LMA group and the endotracheal tube (ET)     group. Airway management will be done with the LMA Protector for the patients of the LMA     group and with the classic endotracheal tube for the patients of the ET group. The main     purpose of the study is to determine if the application of the LMA Protector causes less     laryngopharyngeal symptoms than the endotracheal tube after minimally invasive thyroidectomy.     The secondary purpose is to confirm that the LMA Protector is a safe alternative airway     management device for minimally invasive thyroidectomy.   "
14272|NCT03098654|"     This study focuses on the integration of HIV and NCD screening and care. The investigators     will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of     the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar     es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the     District, one of which will be randomized to receive the enhanced intervention which will     integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing     program, and integrate care for DM and HTN into the HIV care program. Comparisons of the     community HIV testing rates in the two communities, engagement in HIV care among those     testing positive, and 24-month retention in HIV care will be assessed among a cohort of 89     newly enrolled patients per community.      Specifically, the aims are to determine:        1. Whether integrating DM and HTN screening with HIV testing will increase the uptake of          community-level HIV testing.        2. If integrating DM/HTN care with HIV care enhances engagement in HIV care.        3. Whether integration of DM/HTN care with HIV care enhances retention in HIV care for          those newly enrolled in HIV care.        4. The cost-effectiveness of integrating NCD screening and care with HIV screening and care          with regard to the incremental cost per HIV infected client engaged in HIV care, and          cost per newly enrolled HIV client retained in HIV care over 24-months.   "
14273|NCT03098641|"     Pelvic organ prolapse repair involves conservative treatments and surgical treatments.     Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic     prolapse remains essentially surgical. According to detailed medical history and a thorough     physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed     routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated     for transvaginal anterior and posterior surgical repair either as mechanical support or as     reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are     known but only limited data have been reported on the use of Restorelle® in the treatment of     pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of     Restorelle® Direct Fix in pelvic organ prolapse repair.   "
14276|NCT03098589|"     To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter     referred to as Revlimid) under actual conditions of use in patients with relapsed or     refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory     Adult T-cell Leukemia Lymphoma (ATLL)).        1. Planned registration period 3 years        2. Planned surveillance period 4 years and 6 months after a month after the approval for          partial changes in the approved items is granted for relapsed or refractory ATLL   "
14277|NCT03098576|"     The purpose of this study is to examine the usefulness of matching patients to targeted     therapy by analyzing a tumor sample taken at diagnosis and testing it against 50     cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer     treatment that aims to more precisely identify and attack cancer cells, in an effort to do     less damage to normal cells.   "
14278|NCT03098563|"     This research is being done to evaluate whether combining medications that are FDA approved,     but have not yet been approved for combination treatment, can be effective in reducing pain.   "
14281|NCT03098524|"     BACKGROUND. Postoperative pulmonary complications are a leading cause of morbidity and     mortality after cardiac surgery. To this date, there are no recommendations regarding     mechanical ventilation associated with cardiopulmonary bypass (CPB) during the surgery and     anesthesiologists perform either no ventilation (noV) at all during CPB or maintain a     low-tidal volume ventilation (LTV). Indirect evidence points towards better pulmonary     outcomes when LTV is performed but no proper prospective trial with large inclusion of all     types of cardiac surgery has been published.      DESIGN. The MECANO trial is a single-center, double-blind, randomized controlled trial     comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with     CPB. 1500 patients will be included for whom planned cardiac surgery with CPB is performed.     They will be randomized between noV and LTV, on a 1:1 ratio. The noV group will receive no     ventilation during CPB. The LTV group will receive 5 acts/minute with a tidal volume of 3     mL/kg and positive end-expiratory pressure of 5 cmH2O. Primary endpoint will be composite of     overall death, early respiratory failure defined as PaO2/FiO2 ratio <200 mmHg at one-hour     after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either     non-invasive ventilation, mechanical ventilation or high flow oxygen) at 2 days after arrival     in the ICU or ventilator acquired pneumoniae defined by Center of Disease Control. Lung     recruitment manoeuvers will be performed for noV and LTV groups, at the end of surgery and at     the arrival in ICU with an insufflation at +30 cmH20 during 5 seconds. Secondary endpoints     are those composing the primary endpoint with the addition of pneumothorax, CPB duration,     quantity of postoperative bleeding, red blood cells transfusions, revision surgery     requirements, length of stay in the ICU and in the hospital and total hospitalization costs.     Patients will be followed until hospital discharge.      SUMMARY. The MECANO trial compares a no-ventilation to a low-tidal volume strategy for     mechanical ventilation during cardiac surgery with CPB, regarding a primary composite outcome     including death, respiratory failure and pneumoniae.   "
14282|NCT03098511|"     For the purpose of organ donation after neurological determination of death (NDD), death must     be declared using a set of standardized clinical criteria. When a full clinical evaluation     cannot be completed, additional neuroimaging ancillary testing is required. The ideal     ancillary test for NDD would demonstrate no cerebral blood flow, be free of false-positive     and false negative results, rapid, safe, readily available, non-invasive, and inexpensive. No     current ancillary test for NDD meets these criteria. Computed tomography (CT) perfusion has     the characteristics of an ideal test for NDD, but has not been evaluated for routine clinical     use for NDD.      The overarching goal of this project is to improve the NDD process by establishing     CT-perfusion as the ideal ancillary test. A large prospective Canadian multi-centre     diagnostic cohort study will be conducted to validate CT-perfusion for the neurological     determination of death.      Specific objectives are:      Primary objective: To determine diagnostic accuracy of CT-perfusion compared to complete     clinical evaluation for NDD.      Secondary objectives: 1) To confirm the safety of performing CT-perfusion in critically ill     patients suspected of being neurologically deceased; 2) To establish the CT-perfusion     inter-rater reliability for NDD; 3) To evaluate the diagnostic accuracy of CT-angiography     compared to complete clinical evaluation and to CT-perfusion for NDD; 4) To describe the     clearance of commonly used sedatives and narcotics in the setting of NDD; and 5) to     investigate biological changes (inflammatory and nanovesicles) that occur in humans during     the brain dying process.   "
14283|NCT03098498|"     This study compared the gain of periodontal attachment after concomitant one-stage removal of     bacterial biofilms and subgingival calculus with a two-stage procedure removing subgingival     calculus 6 weeks after the initial removal of soft subgingival bacterial biofilms.   "
14284|NCT03098485|"     The objective of this study is to evaluate the impact of antimicrobial (antibiotic) exposures     on the microbiome in healthy adults, specifically during and after usual courses of the     antimicrobials used to treat community acquired pneumonia (CAP). Pneumonia is a lung     infection, and community-acquired pneumonia is pneumonia that develops outside of a     healthcare facility (i.e., in the community). A microbiome is a the community of     microorganisms living in a particular location, such as the gut or the mouth. Disruptions to     a person's microbiome may reduce his/her colonization resistance (resistance to     colonization with pathogenic microorganisms) and make him/her more susceptible to multidrug     resistant organism (MDRO) colonization and infection.      To study changes in the microbiome, the investigators will recruit 20 healthy adult     volunteers and obtain fecal, salivary, skin, and urine specimens at multiple time points     before, during, and after administration of antimicrobials. Participants will be randomized     to one of 4 antimicrobial regimens, all of which are FDA-approved for treatment of     community-acquired pneumonia. Stool specimens will be analyzed via stool culture and genetic     sequencing, and all remaining specimens will be frozen and used to create a biospecimen     repository for future analysis. The rationale for using healthy volunteers (instead of     patients already prescribed antibiotics by their physicians) is because the human microbiome     is very complex and can be affected by a variety of medical conditions and other medications.     In addition, the presence or absence of patient-specific factors means people with infections     may not be prescribed the specific courses of antibiotics the investigators are trying to     study. Studying the effect of antibiotics on healthy volunteers will provide baseline data     that are more applicable to the population at large.   "
14285|NCT03098472|"     Delirium is a syndrome of acute brain dysfunction involving attention and cognition that     affects up to half of older hospitalized patients and 50%-75% of critically ill ICU patients,     such that millions of patients worldwide experience this acute threat to their health and     well being every year. One-third to half of critical illness survivors struggle with a     dementia-like disorder similar in severity to moderate-to-severe traumatic brain injury or     Alzheimer's Disease, and the only proven risk factor that is potentially modifiable is     delirium in the ICU. Despite the frequency and impact of delirium in the ICU, little is known     regarding the biological mechanisms that lead to this form of organ dysfunction during     critical illness. A widely held hypothesis proposes that inflammation is regulated by the     cholinergic system, and that this interaction plays a pivotal role whether delirium     developments in the setting of acute illness. Acetylcholinesterase (AChE) and     butyrylcholinesterase (BuChE) are enzymes that hydrolyze the neurotransmitter acetylcholine.     Changes in the activity of these enzymes, which can be measured in whole blood, reflect     altered regulation of circulating acetylcholine. AChE and BuChE activities have promise as     both predictors of delirium (when found to be low at admission) and biomarkers of delirium     (when low during serial measurement). Neither of these biomarkers, however, have been studied     in the ICU setting where delirium risk is the highest. The current investigation, therefore     will be the first to determine the validity of circulating AChE and BuChE activities as     biomarkers of delirium during critical illness and subsequent cognitive impairment after     discharge. This study will measure whole blood AChE and butyrylcholinesterase BuChE     activities within the framework of the ICU Delirium and Cognitive Impairment Study Group's     ongoing clinical trials in critically ill patients.   "
22301|NCT02993705|"     Multicenter phase II study on trabectedin in patients advanced uterine and ovarian     carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable     toxicity. Disease response evaluation will be assessed every 9 weeks.   "
14286|NCT03098459|"     Cognitive skills are essential to live independently, manage finances, maintain employment,     and function in society. Loss of these cognitive skills puts a tremendous burden on society     as seen with dementias, Alzheimer's disease, and traumatic brain injury. The INSIGHT-ICU     Study (Illuminating Neuropsychological dysfunction and Systemic Inflammatory mechanisms     Gleaned after Hospitalization in Trauma-ICU Study) is the first comprehensive and     longitudinal long-term cognitive impairment study after traumatic injury. The societal impact     of long-term cognitive impairment after trauma is immense given that these patients are young     and constitute a large proportion of employable adults.   "
14287|NCT03098446|"     The purpose of this study is to investigate the effect of 4 days of sitting and moderate     exercise on plasma triglyceride elevation after a meal.   "
14288|NCT03098433|"     This study will assess the short term effects of a single dose of liothyronine on the     cardiovascular system and energy expenditure   "
14358|NCT03097510|"     This randomized controlled trial evaluated the impact of the Transcendental Meditation     program on emotional intelligence and perceived stress in supervisors and administrative     staff in a public school system   "
14289|NCT03098420|"     The study aims to improve the care of the obstetric population after cesarean section and     improve total patient satisfaction by improving post-surgical pain control with the use of     dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a     dose-escalation of dexamethasone in the TAP block to observe its effects at specific small     doses. It is the hope of the investigator that the studied technique would become utilized     routinely for the obstetric population following cesarean section.      The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks     will prolong the duration of the block in a dose-dependent fashion. The investigators hope to     improve post-operative pain following cesarean section, increase duration of TAP block with     use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease     opioid requirements after cesarean section.      The primary endpoint will be estimation of duration of TAP block, being assessed within 48     hours after surgery. Secondary endpoints will include pain scores both in PACU and on the     floor, average pain scores, time until first opioid administration, total opioid consumption     in first 48 hours, use of PONV medications, and overall patient satisfaction.   "
14290|NCT03098407|"     The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to     5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment     for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative.     In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal     outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS)     compared to methadone. However, buprenorphine was also associated with greater study     discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone.     Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing     any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is     to conduct a pilot study to establish the feasibility and acceptability of a randomized     comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally     licensed methadone programs for the treatment of OD pregnant women.      A pilot study is critical to develop the outcome measures, assessment tools and participant     tracking techniques necessary for a future, large-scale comparative effectiveness clinical     trial. An examination of feasibility and acceptability will also allow use to characterize     the subpopulations of OD pregnant women willing to participate in treatment randomization,     identify patient and provider characteristics associated with established treatment     preferences and inform the development of strategies to improve participation and enhance the     generalizability of the future large-scale clinical trial.   "
14291|NCT03098394|"     The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG     test on treatment of female patients in the emergency department or urgent care setting with     possible STIs.   "
14292|NCT03098381|"     One of religious duties for all healthy adult Muslims is fasting during Ramadan, the ninth     month of Islamic lunar calendar. In this month, Ramadan observance fasted (no food and drink)     from dawn to dusk. Studies demonstrated daytime fasting may pose a positive significant     effect on metabolic health. Thus, this present study aimed to determine the effect of Ramadan     fasting on body composition, metabolic profile, serum leptin and adiponectin levels in     healthy men.   "
14293|NCT03098368|"     Parkinson's disease (PD) is the neurodegenerative disease which is caused by Lewy bodies     deposition in central and peripheral nervous system. The mains symptoms include both motor     and non motor symptoms such as bradykinesia, rigidity, rest tremor, postural instability,     autonomic dysfunction or neuropsychiatric symptoms. Moreover, the PD symptoms not only occur     in the daytime, but also in the nighttime. The nighttime symptoms or nocturnal symptoms can     make the patients disabling as well as the daytime symptoms. The bradykinesia that occurs in     the nighttime is called nocturnal hypokinesia which also make many serious consequences such     as bedsore, falling or aspiration or death.      In this study, the investigators aim to study the effects of rotigotine transdermal patch     compare to placebo on mainly the aspect of nocturnal hypokinesia.   "
14294|NCT03098355|"     Clinical studies of CD19 CAR-T cells in the treatment of blood and lymphatic system tumors     have achieved unprecedented successes. Because of the heterogeneity of the tumor, patients     often carry CD19-negative tumor cell clones that express alternative target antigens (such as     CD22, CD20 and CD123). In order to effectively eradicate all tumor clones and prevent     recurrence, alternative tumor antigens besides CD19 are considered for CAR-T cell targeting.     In this tudy, autologous T cells are genetically modified with 4th generation anti-CD19 and     anti-CD22 CARs (4SCAR19/22) using lentiviral vectors. For safety consideration, the 4SCAR is     engineered with an inducible caspase 9 self-withdrawal genetic design that allows for rapid     elimination of the infused CAR-T cells. Interleukin-2 has been shown to boost immune response     against leukemia cells. The serum interleukin-6 level will be monitored and when it returns     to normal range by day 28 after CAR-T cell infusion, patients will receive subcutaneous     injection of interleukin-2, and evaluated for 24 months for safety, efficacy and persistence     of CAR T cells.   "
14295|NCT03098342|"     Study centre and address      King Chulalongkorn Memorial Hospital      Primary objective      To compare the efficacy and the safety of methylene blue-mediated photodynamic therapy and 5%     amorolfine nail lacquer for toenail onychomycosis in Asians   "
14296|NCT03098329|"     This study, named Check it, is a bundled program for African American (AA) men ages 15-24     that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects     who test positive and their female sexual contacts, and rescreening for these two sexually     transmitted infections.   "
14306|NCT03098199|"     This is a research study on a hormone in women called anti-mullerian hormone (AMH) an     indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to     determine the AMH level. This knowledge will help the investigators decide a dosage of     gonadotropins, the hormones used to stimulate the production of more than one egg for use in     an in vitro fertilization (IVF) cycle. The amount of gonadotropin given has to be tailored to     each individual participant. The investigators can use information about the participant and     the hormone levels to determine this dosage and the chances of becoming pregnant as a result     of IVF treatment. The reason the investigators are doing this research is to find out if     basing the gonadotropin dosage solely on the participant's AMH level will give the     investigators a better result than the previous method based on age and other hormone levels.   "
14297|NCT03098316|"     Metabolomics consists in the study of metabolites in body fluids or tissues. It investigates     the consequences of the activity of genes and proteins. One of its advantages is that it is     able to do a simultaneous measurement of metabolic changes in living organisms as a response     to a disturbance (disease, diet, environment, others) and because a metabolic profile is     summative of all the biochemical processes occurring in the body at a given time, it makes no     presumption about the relative importance of these processes. Ultimately it is a fingerprint     of the organism's health status, at a given time.      Metabolomic analysis of serum, plasma and urine has revealed panels of metabolites that     distinguish patients with cardiovascular disease, breast cancer, Parkinson disease,     Alzheimer's disease and diabetes from control patients. Regarding ocular diseases only few     studies have been published, related to diabetic retinopathy, retinal detachment, age-related     macular degeneration, uveitis and glaucoma.      Glaucoma is one of the leading causes of blindness in the world, according to the World     Health Organization, and there are still no biomarkers that can provide an early diagnosis.     Nowadays, glaucoma classification relies substantially in the measurement of intraocular     pressure (IOP), which can be rather artificial and also unreliable since IOP values can     fluctuate during the day. Moreover, patients with normal IOP values can also develop     glaucomatous neuropathy (normal-tension glaucoma, NTG) and progress even when IOP is     decreased. Several studies have shown that NTG patients suffer from a systemic vascular     dysregulation, with higher rates of systemic hypotension, Raynaud phenomenon and migraine.     Hence, other mechanisms than an increased IOP are of importance in the development and     progression of glaucoma.      Only one metabolome-wide study has been made in glaucoma (Burgess, I.; 2015). In a sample of     72 american patients with primary open angle glaucoma (POAG), the authors found significant     differences in comparison to controls.      The hypothesis for this study is that glaucoma patients will differ from controls, and POAG     patients will differ from NTG patients. The investigators will look into metabolomics as a     way to create a method to diagnose and stratify patients, as an add-on or alternative to the     currently available diagnostic tools like IOP, functional and structural measurement.   "
14298|NCT03098303|"     The primary objective of this study is to determine the variables associated with patient     acceptation or refusal to participate in a clinical research protocol when seen in during a     pneumology consultation (excluding oncology and tobaccology).   "
14299|NCT03098290|"     The prevalence of peripheral arterial disease (PAD) and the proportion of endovascular     procedures for treatment are increasing worldwide. For many cases of treatment or procedures     no randomized controlled trials (RCT) or results from meta-analyses are so far available. The     decision for treatment and selection of procedure is therefore not uncommonly left up to the     personal expertise of the physician. The IDOMENEO study represents a multistage     multimethodological project for healthcare research and quality assurance in     interdisciplinary vascular medicine, which undertakes a comprehensive examination of this     topic. Various methods and data sources (even routine data) are linked in a meaningful way.     The essential components of the total project are implementation of a register platform     (GermanVasc), which conforms to data protection and data security as well as the development     of instruments for valid measurement of the quality of life of patients with PAD. The data     protection-conform linking of primary data in the register and routine data of the consortium     partner BARMER should also enable validation of the data sources.   "
14300|NCT03098277|"     This clinical trial studies movement tracking devices in optimizing and monitoring physical     activity in patients with solid tumors undergoing chemotherapy in a health care facility     during the day without spending the night. Movement tracking devices, such as Microsoft     Kinect 2 and Microsoft Band 2, may help doctors learn about the health of cancer patients.   "
14301|NCT03098264|"     For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on     biliary stone and portal hypertension simultaneously or separately by staged surgery.There's     a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for     these patients.How to develop a optimized algorism of simultaneous and staged surgery is     highly needed.   "
14302|NCT03098251|"     According to a large amount of case affected with hepatolithiasis, we developed a typing     system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could     predict a more precise construction of this disease, hence, typing by 3D conformation will     improve the outcome of surgical treatment.The investigators will use a multicenter     ambispective cohort study to test this hypothesis.   "
14303|NCT03098238|"     Context and rationale:      Antibody-mediated rejection is the leading cause of long-term renal graft loss. It's due to     the production by the recipient of antibodies directed against antigens (belonging or not to     the HLA system) present on the surface of the donor specific endothelial cells (DSA), leading     to graft failure.      The main difficulty to manage the humoral rejection is the delay of the diagnosis and the     treatment to slow the evolution towards fibrosis.      Positivity of anti-HLA antibodies is the main risk factor for the rejection but the only way     to make the diagnosis of humoral rejection is to perform a graft biopsy, an invasive process.      Endothelial microparticles (MPE) are small membrane vesicles generated by endothelial cell     activation and / or apoptosis processes.      We test the hypothesis that endothelial microparticles are an early diagnostic biomarker of     humoral rejection in renal transplantation allowing to detect it at the subclinical stage.      Primary and secondary objectives:      The main objective of this study is to estimate the performance of MPE plasma concentration     for the diagnosis of humoral rejection in renal transplant patients with DSA. The secondary     objective is to investigate by mass spectrometry the MPEs specific to the endothelium of the     graft and to evaluate their diagnostic performance in relation to non-specific MEPs      Methodology :      We will conduct a cross-sectional evaluation of a diagnostic method from a collection of     biological samples. The gold standard for the diagnosis of humoral rejection is the     histological diagnosis on graft biopsy. The new test under study will be the flow cytometric     assay of the MPE concentration carried out on plasma taken on the day of the graft biopsy.      Feasibility:      Among the active list of renal transplant patients attending the Montpellier University     Hospital, we estimate that we can include the number of subjects required (N = 250) over 18     months. This work will be carried out in a laboratory with all the tools and techniques used,     in particular flow cytometry and mass spectrometry, perfectly mastered and realized on     dedicated technical platforms      Benefits / Outlook:      find a non-invasive early diagnostic biomarker to detect humoral rejection from the     subclinical stage in order to set up an adapted treatment as quickly as possible.   "
14500|NCT03095664|"     The objective of the present study is to implement and evaluate the effect of a counseling     program to promote healthy eating and practice of physical activity in the nutritional     status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.   "
14304|NCT03098225|"     Graves' orbitopathy (GO) is a disfiguring and disabling disease that profoundly impairs the     quality of life of affected patients. High dose intravenous (iv) glucocorticoids (GC) (ivGC)     is a well established, widely used treatment for active GO. The use of systemic     glucocorticoids takes advantage from their immune suppressive and antiinflammatory actions,     resulting in an overall beneficial effect ranging from ~35 to ~60% of patients in various     studies. The intravenous route of administration has been shown to be superior to the oral     route, both in terms of GO outcome and side effect profile. The combination of ivGC and     orbital radiotherapy (OR) is used routinely in patients with moderate-severe, active GO, as a     second-line treatment, as also recommended in the recent Guidelines published by the European     Thyroid Association/European Group on Graves' Orbitopathy. Thus, the majority of studies have     shown that OR increases the response rate to GC. Those studies were performed using oral GC,     whereas it is not known whether OR potentiate also the effects of ivGC.      The present study is aimed at determining whether OR potentiate the effects of ivGC in the     treatment of moderately severe and active GO, in terms of GO outcome and quality of life. A     possible extension of the study can be foreseen, aimed at investigating the very long time GO     outcome.   "
14307|NCT03098186|"     Purpose of the trial: To evaluate the efficacy and safety of an intervention with SMS     messages delivered by mobiles phones to improve adherence to cardiovascular medications in     patients with atherosclerotic cardiovascular disease (ASCVD).      Trial design: Two-parallel arm, single-blind, individually randomized controlled trial.      Primary endpoint: Differences in changes (baseline minus 12 months) of: Low density     lipoprotein cholesterol (LDL-C), Systolic Blood pressure and Heart Rate.      Secondary endpoints: Differences in the changes (baseline minus 12-months) of: (i) adherence     to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire;     and (ii) Urinary levels of 11 dh-TxB2, Rates of composite end-point of cardiovascular death     and hospitalization due to cardiovascular disease up to 12 months, Rates of composite of     non-cardiovascular death or hospitalizations due to non-cardiovascular disease up to 12     months and Adverse events: traffic accidents and injuries while reading SMS related to the     trial.      Duration of follow-up: 12 months      Trial treatment:      Intervention: The active treatment will consist of SMS that are aimed to modified behavioral     factors associated with poor adherence to cardiovascular medications used in secondary     prevention. The SMS will be delivered daily during the first month, increasing one day of     interval for each week during the second month, and weekly thereafter until end of month     12th. In addition, they will receive SMS thanking for their participation in the trial,     reminders of trial appointment and informing if they have changed contact details. The     frequency of this SMS will be monthly.      Control: participants will only receive the SMS thanking for their participation in the     trial, reminders of trial appointment and informing if they have changed contact details. The     frequency of this SMS will be monthly.      Expected sample size, enrollment and expected number of centers:      Sample size = 1600 Recruitment start date: March , 2017 Recruitment end date: September, 2017     Follow-up end date: March, 2018 Number of centers: 1      Statistical considerations:        -  Intention to treat analysis        -  The trial has >90% power (2 sided alpha= 0.05) to detect a reduction in LDL-C as low as          5.1 mg/dl, under the assumption that SMS will increase adherence to statins by 7%.        -  The primary outcomes will be analyzed using ANCOVA.      Partially Financed by COLCIENCIAS Code: 656672553352   "
14308|NCT03098173|"     This multi-center, randomized controlled trial study is planned to include 162 outpatients     with onset of acute lower gastrointestinal bleeding to compare the rate of identification of     stigmata of recent hemorrhage (SRH), and other clinical outcomes, including the 30-day     rebleeding rate, between 'early' colonoscopy and 'elective' colonoscopy.   "
14309|NCT03098160|"     An immunotherapy study combining ipilimumab and evofosfamide for the treatment of patients     with confirmed metastatic or locally advanced prostate cancer, metastatic pancreatic cancer,     melanoma or human papillomavirus (HPV) negative squamous cell carcinoma of head and neck that     have failed to respond to standard therapy, progressed despite standard therapy, for which     standard therapy does not offer the potential for increased survival.   "
14310|NCT03098147|"     Lower urinary tract symptoms(LUTS) are the main symptoms of benign prostatic     hyperplasia(BPH), a benign but progressive disease which can advance to be with overactive     bladder(OAB) symptoms. Moreover, LUTS and OAB symptoms can badly influence patients'     especially the elderly's quality of life. Therefore, it appears to be urge to carry out     researches on the functional impairment of bladder along with the advance of BPH. Besides,     the management aimed at improving the LUTS and OAB symptoms come to be the key one among the     management of BPH. For a long period, medication and surgery sustain to be the two most     common therapies for BPH patients. Both patients and urologists prefer pharmacotherapeutics     to surgery，which contributes to the rising number of BPH patients companied with OAB symptoms     and storing symptoms complaint post-surgery. In fact, investigators usually find bladder     impairment macroscopically in the BPH surgery: mild may be the trabeculation, worse can be     the cabin, and severe may be the diverticula. Furthermore, it's not uncommon that patients     with a long BPH history continually suffer from dysuria after surgery due to the detrusor     muscle weakness. Consequently, investigators need to catch a moment when investigators should     operate on such a patient in order to harvest a satisfying outcome. And perhaps the moment     should be ahead of the existing guideline suggests. Thus, for understanding the influence of     BPH on bladder function, investigators plan to conduct a prospective, case-control study     recruiting in-patients with different degree of obstruction. Our team wish that such a     clinical trail could provide valuable evidence for us to find out relatively better operating     timing and serial indications. For the purpose of improving the quality of life and prolong     life-span, investigators design the study above to maximum the operating outcome and minimize     the bladder dysfunction.   "
14311|NCT03098134|"     Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed     dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR     exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy,     participants will be evaluated with a questionnaire battery, diagnosed with a structured     clinical interview and will participate in a psychophysiological symptom assessment. Then,     after a 2-week waiting period, participants again fill in questionnaires, and the     Intervention will take place. Within 2-weeks after the second questionnaire assessment     participants will be screened with the structured interview again and will fill in     questionnaires.   "
14312|NCT03098121|"     This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and     well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs     (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.   "
14313|NCT03098108|"     The investigators conduct this study to evaluate the efficacy and adverse effect of salvage     concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously     irradiated recurrent rectal cancer.   "
14314|NCT03098095|"     Physical activity delays all-cause mortality in the general population and reduces the risk     of cardiovascular disease (CVD), stroke, type-2 diabetes and some types of cancer (Garber et     al., 2011). These diseases are associated with chronic inflammation, which is characterized     by activation of inflammatory signalling pathways with abnormal production of cytokines and     other mediators (Hotamisligil, 2006). Observational studies of large population cohorts have     consistently shown an association between physical inactivity and low-grade systemic     inflammation and interventional studies a reduction of inflammatory markers following     exercise (Beavers et al., 2010).      Chronic inflammation is also a predominant feature of treated human immunodeficiency virus     (HIV) infection (Lederman et al., 2013; Deeks et al., 2013). Compared to age-matched     HIV-negative subjects, persons with chronic HIV infection are at higher risk to develop     non-acquired immune deficiency syndrome (AIDS) related chronic diseases (Guaraldi et al.,     2011), and several studies have shown an association between chronic inflammation and higher     cardiovascular risk and overall mortality (Kuller et al., 2008, Duprez et al., 2012).      Recently, the investigators performed a pilot study of moderate physical activity that     enrolled sedentary HIV infected subjects treated with combination antiretroviral treatment     (cART), consisting of brisk walking, with or without strength exercise. Overall, after 12     weeks of training cholesterol profile and soluble and cell inflammatory markers improved     significantly. However, because of the considerable individual variability in exercise     responses, a program of physical activity needs be adjusted on an individual basis to be most     effective. During recent years, the use of mobile technologies has been implemented for     health monitoring interventions, including exercise. We hypothesized that the use of a mobile     application will favour engagement to exercise by providing motivational inputs, and     therefore adherence, and, as a consequence, an improvement of physical fitness.      The investigators hypothesized that the use of a mobile application will favour engagement to     exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an     improvement of physical fitness. Therefore, the aim of this project is to improve health and     quality of life of patients living with HIV through self-empowerment by use of an innovative     mobile application, in order to assist and monitor individualized program of physical     activity and diet recommendation.      OBJECTIVES      Primary To compare the improvement of physical fitness between the EG and CG groups after 16     weeks of training.      Secondary      To compare the improvement of the following characteristics between the EG and CG groups     after 16 weeks of training:        1. anthropometry,        2. Blood lipids,        3. Inflammatory markers,        4. Quality of Life,      4. Mood State.      ENDPOINTS Primary The primary objective will be assessed by the proportion of subjects with     an improvement from baseline of 15% of maximal oxygen consumption (O2max) through 16 weeks of     training.      Secondary      The secondary endpoints will be assessed by the 16-week changes in the following measures:        1. BMI and %Fat Mass,        2. Blood Total-, LDL-, HDL-Cholesterol,        3. Blood IL-6, hs-PCR, d-Dimer, IL-18; myostatin; T-cell activation markers,        4. F12 questionnaire,        5. Profile of Mood State questionnaire.   "
14325|NCT03097952|"     Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide.     Patients with chronic HBV infection are at an increased risk for developing hepatic     cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the     outcome of chronic HBV infection were identified, more precisely determine the factors which     are associated with the outcome in non-selected patients with chronic HBV infection are still     needed. The investigators purpose is to constitute a observational cohort of non-selected     Chinese patients to create a database of epidemiological, clinical, biological, virological,     immunologic and therapeutic parameters, in order to determine factors associated with the     outcome of chronic HBV infection.   "
14315|NCT03098082|"     Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most     common, serious complication of ERCP. More than 500,000 ERCP procedures are performed from     which 25,000 cases of PEP occur in the U.S.A. annually. PEP accounts for significant     morbidity and health care expenditures. While symptoms of PEP arise immediately after ERCP,     they are non-specific. Consequently, unnecessary admissions of outpatients without PEP and     inadvertent discharge of outpatients with PEP from ERCP recovery are common. An accurate,     confirmatory test for diagnosis of PEP immediately after ERCP is lacking. Actim Pancreatitis     (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a     biomarker for acute pancreatitis. Urine Trypisinogen-2 Dipstick test (UTDT) is a simple,     inexpensive test with promising preliminary data for accuracy for immediate diagnosis of PEP.     Prior studies of ITDT test characteristics lack rigorous scientific design. Investigators     will enroll 1825 ERCP outpatients at our institution in a prospective cohort study. A     pre-ERCP UTDT test and diagnostic UTDT 2 hours after the ERCP will be performed. Patients     with a positive baseline UTDT will be followed clinically as part of this study without 2     hour testing. Care providers and study primary investigators will be blinded to the 2 hour     UTDT results. Baseline, intra-procedure and recovery room clinical data will be recorded.     Diagnosis of PEP will be made blinded to the UTDT result. Admission status for PEP will be     assessed by review of records and phone/e-mail contact 5 days and 30 days after ERCP     procedure. Sensitivity and specificity of 2 hour post ERCP UTDT for the diagnosis of PEP will     be calculated.      Aims: 1) To determine the test characteristics of UTDT for the diagnosis of PEP 2 hours after     completion of ERCP. 2) To identify and describe patients with baseline UTDT positivity, in     whom this test offers limited utility.      Specific Aims:      Primary Aim 1.1 To determine the test characteristics (sensitivity and specificity) of the     UTDT for the diagnosis of PEP:      Hypotheses:        1. UTDT is a sensitive and specific test for the diagnosis of PEP for patients undergoing          ERCP.        2. At a cutpoint for a negative test of <50ug/L, UTDT will be accurate at 2 hours post ERCP          in patients whose baseline test is negative.   "
14316|NCT03098069|"     This implementation research aims to accelerate effective and high coverage of Kangaroo     Mother Care in district Sonipat in the state of Haryana, India. The project is being led by     government of Haryana. KMC units will be set up in selected government and private delivery     facilities. KMC will be initiated for all babies with birth weight less than 2000 gm in the     facilities (either in born or referred from elsewhere) and continued at home post discharge.     These babies may be either born in the facility or referred to the facility. A linkage with     community health workers will be established to support mothers to continue KMC at home.   "
45339|NCT02692196|"     Real-time fMRI neurofeedback training induced volitional control of brain activity and     connectivity could help individuals to gain better control over their emotions.   "
14318|NCT03098043|"     In light of the widespread organ shortage, dynamic preservation by means of Machine Perfusion     (MP) has been proposed as a strategy to increase the pool of suitable grafts for liver     transplantation. Reproducing more physiological conditions than traditional Static Cold     Storage (SCS), MP may allow a better preservation and evaluation and perhaps even the     resuscitation of high risk grafts. As a consequence, unnecessary discard of organs could be     avoided and quality and safety of transplantation could be improved as well.      Hypothermic MP (HMP) seems to reduce ischemia-reperfusion injury. In fact, hypothermia slows     down the metabolic rate and the oxygenation of the perfusate leads to re-synthesis of     Adenosine TriPhosphate (ATP), which results in the restoration of cellular energy.      Four series about the use of HMP in the clinical setting has been published so far. They all     report acceptable outcomes after transplantation of human liver grafts from extended criteria     Brain Dead Donors (BDD) and from Donation after Circulatory Death (DCD) donors preserved by     HMP, thus proving its feasibility and safety. The efficacy of HMP, instead, is still under     investigation in a phase II randomized trial.      This is an observational, prospective, monocentric study aiming at verifying the feasibility     and safety of post-SCS Hypothermic Oxygenated PErfusion (HOPE) in the setting of our liver     transplant program. Extended criteria grafts from BDD and grafts from DCD donors will be     preserved by post-SCS HOPE prior to transplantation. The recipients of these grafts will be     followed-up for at least 1 year.   "
14320|NCT03098017|"     Carbohydrate-based products can influence the post-prandial glycemic response differently     based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta     is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature     describe a lower glycemic response after the consumption of pasta compared with other     wheat-based products, such as couscous. Among the factors affecting post-prandial glycemia     after consumption of carbohydrate-based products, the technological process represents a     central one. In fact, the different technological processes alter the food matrix which can     affect the post-prandial metabolism of glucose and insulin differently. Thus, the present     study aims at investigating the effect induced by the principal steps of the process of pasta     production on the reduction of post-prandial glycemic and insulinemic responses compared to a     similar durum wheat based product, couscous.   "
14321|NCT03098004|"     This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet)     flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke     among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of     nicotine abstinence. The study's experimental design will provide evidence of the causal     effects of e-cigarette flavorings on a putatively critical factor for determining whether     smokers continue e-cigarette use after initial trial—the ability of a product to suppress     withdrawal and motivation to smoke during periods of tobacco deprivation.   "
14322|NCT03097991|"     This R01 tests through RCT methodology efficacy of a new intervention designed specifically     to aid development of positive coparenting alliances between at-risk (unmarried, uncoupled,     low income) African American mothers and fathers having a first baby together.   "
14323|NCT03097978|"     Targeted Muscle Reinnervation increases the control signals available for commercial arm     systems. A new type of control, pattern recognition, has been developed into a form that     allows use with commercially available arm system. The goal of this project is a home trial,     in which people who have had TMR will try the new controls and the new arm to find out if     they are better than what is currently available. Home trials will also allow us to see what     needs to be done to make our inventions work even better.   "
14324|NCT03097965|"     The study evaluated and compared the safety, tolerance and acceptability of a lifestyle     modification program with or without nutritional supplementation in generally healthy     overweight subjects with cardiometabolic risk factors.   "
14326|NCT03097939|"     The purpose of this study is to test the hypothesis that a combined Immuno-Oncology (IO)     strategy would see efficacy in a virally driven cancer like Nasopharyngeal Carcinoma (NPC).     Hence, this is a combination study of nivolumab and ipilimumab in Epstein-Barr virus (EBV)     driven nasopharyngeal carcinoma.   "
14630|NCT03093961|"     The objective of this pilot study is to evaluate the safety and performance of implanting the     IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left     sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy     (GDMT).   "
14327|NCT03097926|"     The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch     (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic     limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein     deficiency, vitamin and trace element deficit compared to standard BPD-DS.   "
14328|NCT03097913|"     To investigate the double curve endotracheal tube safely navigate through nasal cavity under     guidance of a video-stylet.   "
14356|NCT03097536|"     Patients with migraine often report that stressors such as skipping a meal can bring on a     migraine whereas some patients report that their migraine improves with food. Few studies to     date have looked at the relationship between blood glucose (sugar) and migraine. We are     conducting this study to better understand whether or not changes in blood glucose levels can     trigger migraine or provide relief during a migraine attack.   "
14329|NCT03097900|"     Postoperative ileus is a frequently occurring surgical complication. It is defined as     temporary inhibition of propulsive bowel activity and is manifested by abdominal distention,     nausea, vomiting and diet intolerance. It may lead to a prolonged hospital stay,     hospital-acquired infections or complications that may require additional treatments (e.g.     analgesia, fluids, electrolyte replacement, nasogastric tube decompression), and as a result     increase medical costs.      Previous studies showed that postoperative coffee consumption shortens the time to first     bowel movement after colorectal resections. However, none could explain the mechanism by     which coffee stimulates intestinal motility and the determinant agent for this action is     still up for discussion (either caffeine or another coffee component).      Coffee has a negligible caloric content; It has a pH that varies from 5 to 6 (less acidity     than other beverages that have no similar effect on bowel motility) and it is hypotonic.     Therefore, it is highly unlikely that bowel motility is due to the physical properties of the     coffee. Much more likely, that one (or more) of the numerous phytochemicals of the coffee     bean are responsible for this effect, when the most obvious candidate seems to be caffeine.     However, as mentioned above, very little evidence exists that caffeine was responsible for     the observed effect on colonic function in previous studies.      The purpose of this single-centered, prospective, single blinded, randomized clinical trial     is to evaluate whether the use of caffeine in the post-operative period significantly reduces     the duration of postoperative ileus, and therefore, improves recovery and shorten the     hospital stay.      The study hypothesis is that post-operative use of caffeine will reduce time to recovery of     GI function (post-operative ileus) by at least 15 hours and thus reduce hospital length of     stay by at least 15 hours in patients undergoing elective colorectal operations.      50 patients due to undergo large bowel resection via laparotomy or laparoscopy will be     enrolled and randomized (1:1) to those who will receive caffeine (100 mg 3 times per day) and     those who will receive placebo (tap water) starting on the morning of postoperative day 1     after surgery until flatus will occur for the first time or to a maximal period time of 7     days, whichever comes earlier.   "
14330|NCT03097887|"     This proposed trial is designed to answer the following questions: First, is biliary reflux     to the distal esophagus present before OLGB and does it increase after the procedure? Second,     does performing an OLGB with or without anti-reflux sutures make a difference in (biliary)     reflux exposures of the distal esophagus? To answer these questions the investigators plan to     perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB     without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with     anti-reflux sutures and also consists of 50 patients.      Gastroscopic evaluation for inflammation and reflux will be performed before and one year     after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and     intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term     weight loss, the resolution of comorbidities and the incidence of surgical complications will     serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months     postoperatively to assess all primary and secondary goals.   "
14331|NCT03097874|"     The investigators are conducting a randomized controlled trial using an adaptive design for     adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment     (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do     not reach expected milestones by session 4 of treatment, participants may be randomized to     receive additional IPC or continue treatment as usual with regular FBT.   "
14332|NCT03097861|"     To evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as     compared to placebo, when administered orally in subjects with CIC.   "
14333|NCT03097848|"     Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma     (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of     RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this     study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency     ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.   "
14334|NCT03097835|"     The purpose of this study is to comprehensively investigate and objectively demonstrate the     effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more     specifically evenness of skin tone, reduction of pore size and improvement in the appearance     of preexisting skin scars.   "
14335|NCT03097822|"     Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma     using Dynamic Contrast-Enhanced (DCE) MR Imaging   "
14336|NCT03097809|"     Using the novel analysis of stereo-electroencephalography (SEEG) recordings, this proposal     will investigate the activity and connectivity of mood regulation circuits in subjects with     suspected epileptic focus who have undergone SEEG electrode implantation for monitoring of     seizure activity.   "
14337|NCT03097796|"     Subjects with hematologic malignancies or recipients of a first allogenic or autologus     hematopoietic stem cell transplant, without any evidence or respiratory infection, will     receive 4 doses of PUL-042 Inhalation Solution over a 2 week period. Subjects will be     evaluated for tolerability of the drug. If tolerated, dose escalation may occur with up to 4     dose levels tested   "
14338|NCT03097783|"     This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to     evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface     Volume Deficit and/or Midface Contour Deficiency.   "
14339|NCT03097770|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous or donor-derived T cells may make the body build immune response to     kill cancer cells.      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in     treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell     transplantation or intensive chemotherapy) or refractory to chemotherapy.   "
14393|NCT03097055|"     This study will have acupuncture intervention in acute ischemic stroke patients and evaluate     the effect in neurological function improving by National Institutes of Health Stroke Scale     (NIHSS), Modified Rankin Scale (mRS), Barthel Index, and antiinflammatory actions by     biomarkers.   "
14340|NCT03097757|"     The primary objective of this study is to assess the utility of ultrasound guidance in the     closed reduction of pediatric forearm fractures in the pediatric emergency department. The     investigators will compare post-reduction radiologic outcomes between the experimental group     (ultrasound guided closed forearm fracture reduction) and control group (standard of care     blinded closed forearm fracture reduction) to determine if there is a difference in the     number of adequate reductions between groups.      Secondary objectives include comparing provider satisfaction with the reduction procedure,     number of patients requiring repeat reductions, time for reduction, number of patients     requiring operative repair after reduction, with the reduction procedure and comparison     between post-reduction ultrasound and x-ray interpretation.   "
14341|NCT03097744|"     This is a retrospective study of meniscal tear repairs at least one-year post repair status.     All patients were treated with Ceterix NovoStitch devices. The primary objectives of this     study are to assess the clinical repair success rate via reoperation and PROs at greater than     12 months.   "
31132|NCT02878252|"     The purpose of this study to determine the proportion and clinical characteristics of COPD     patients with asthma symptoms (ACOS) and describe current practices in diagnosis and     management in Viet Nam and Taiwan.   "
14342|NCT03097731|"     The presentation of IBD in early childhood is uncommon and the monogenetic defects,     especially IL-10 signaling pathway play a key role in very early onset inflammatory bowel     disease (VEO-IBD). IL-10 or IL-10R deficiency associated VEO-IBD is considered a rare     disorder. To date, there were about 60 cases were reported all over the word. But in our     Chinese VEO-IBD Collaboration Group, 42 patients with biallelic mutations affecting IL10R     genes were identified from 93 VEO-IBD patients, and the mutation sites are highly     concentrated, including 83.9% (26/31) with p.R101W and 55% p.T179T (17/31) mutation, and the     proportion of patients from Henan( A province of China) is higher. So we speculate that     IL-10RA mutation may not be very rare, and the frequency of heterozygote subjects might be     higher than suspected.   "
14343|NCT03097718|"     This project aims to elucidate neural correlates of proprioceptive deficits in patients with     recurrent non-specific low back pain, by studying whether brain activation patterns during     the processing of proprioceptive signals from the ankle muscles and lower back muscles are     altered compared to healthy control subjects.   "
14344|NCT03097705|"     The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular     pressure during surgery and on the retinal nerve fiber thickness after surgery   "
14345|NCT03097692|"     An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and     inflammatory process is well known . Ischemic preconditioning reduces the inflammation   "
14346|NCT03097679|"     The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal     hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF     in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial     disease.      The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be     enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low     COF group (Pulsar).   "
14347|NCT03097666|"     The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe     Ablation System (CryoBalloon Swipe) used at increasing doses.   "
14348|NCT03097653|"     The present study aim to assess the effect of an interactive web decision aid on informed     choice - measured via knowledge, attitudes and intentions concerning breast cancer screening     - comparing the decision aid with a standard information provided via web.   "
14349|NCT03097640|"     This study evaluates the clinical outcomes of a novel program designed to target patients who     are high-utilizers of hospital services. Patients who are frequently admitted to medical     services - high-utilizers - present a unique set of challenges to providers and the health     care system that require a different way of approaching chronic illness. The Complex High     Admission Management Program (CHAMP) is an innovative model of care consisting of a small     team of providers who establish continuity relationships with high-utilizer patients. CHAMP     strives to provide effective, high value care via a longitudinal relationship-based care     model through provider continuity, intensive case management, and personalized care plans. To     better understand the potential outcomes of CHAMP, this study is a longitudinal, prospective,     randomized, controlled trial of medical high-utilizers enrolled in CHAMP compared to a group     of high-utilizer patients receiving usual care.   "
14350|NCT03097627|"     This is a clinical trial to evaluate the intravenous administration of indocyanine green     (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine     if intravenous ICG allows us to identify intra-thoracic lesions.   "
14351|NCT03097601|"     Metastatic renal cell carcinomas (mRCC) are highly angiogenic tumors because of mutation of     the pVHL gene leading to over-expression of VEGF. Therefore, mRCC represent a paradigm for     the use of anti-angiogenic treatments targeting the VEGF/VEGFR pathway. Despite an increase     of the time to progression these treatments, taken alone, are not curative with ineluctable     progression especially for the reference treatment sunitinib a multi kinase inhibitors of     VEGF, PDGF, CSF1 receptors and c-kit, FLT3 and RET. At progression on sunitinib, patients     received mTOR inhibitors which is responsible, at least, of HIF1A mRNA translation, then on a     third line sorafenib that inhibits VEGFR2, 3 PDGFR, c-KIT and B-RAF. The access to these     different lines of treatment has finally prolonged survival but this situation is not     satisfactory. Unexpected aspect associated with the use of anti-angiogenesis treatments was     the diversity of the patients' response. Some patients are right away refractory and die     rapidly, but the majority of patient has a transient response then progress and a few     percentages of them are responder for a very long period of time. By only targeting normal     endothelial cells and tumor neo-vascularization, the response should have been more     homogenous, thus highlighting that the treatment induced a Darwinian adaptation of tumor     cells and cells of the microenvironment. Two conclusions follow from these observations: 1-     The need to identify predictive markers of efficacy; 2-The identification of druggable     targets participating in progression on anti-angiogenic treatments. Our results have     highlighted the ELR+CXCL cytokines, pro-inflammatory and pro-angiogenic cytokines as     prognosis markers of survival of mRCC patients and relevant therapeutic targets on     experimental tumors in mice. As VEGF/VEGFR, these cytokines are produced by tumor,     endothelial and inflammatory cells. Their receptors (CXCR1, 2) are expressed physiologically     by immune and endothelial cells and aberrantly by tumor cells generating at the same time     autocrine proliferation loops, chronic angiogenesis and inflammation. Therefore, the     CXCL/CXCR1,2 axis constitutes an independent axis of cancer development and propagation.     However, the current standard of care is to administer anti-angiogenic therapies as the first     line treatment. The objective of this project is linked to the identification of potent     predictive markers of efficacy, easily measured in plasma samples. Deciphering the molecular     mechanisms associated with the production of such cytokines by tumor cells and by cells of     the microenvironment represents an interesting intellectual challenge and a relevant way to     improve the current treatments by targeting, at progression on the current standard of care,     other pathways than the VEGF/VEGFR axis.   "
14424|NCT03096652|"     Comparing standard midline approach with the modified approach in management of morbid obese     patients with gynecologic cancers.   "
14352|NCT03097588|"     This phase II trial studies how well netupitant and palonosetron hydrochloride work in     preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing the     BEAM conditioning regimen before stem cell transplant. Chemotherapy, such as carmustine,     cytarabine, etoposide, and melphalan (BEAM), makes people feel sick to their stomach and     causes vomiting. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting     caused by the BEAM treatment.   "
14353|NCT03097575|"     This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye     indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is     to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or     transthoracic allows us to identify the first lymph node that drains from the tumor, and thus     would be the most likely site for metastatic disease, and remove it for analysis to improve     the ability to detect tumor in this node and to remove this additional site that potentially     contains tumor cells. Using this intraoperative imaging technique, we aim to improve the     identification of lung nodules for resection and the intraoperative identification of     sentinel lymph nodes in the event that a lymphadenectomy is performed.   "
14359|NCT03097497|"     Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the     pre-activation of the transverse abdominal muscle decreases pain intensity in patients with     chronic non-specific low-back pain by at least 30% and is more effective than conventional     treatment.      Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education     program based on the pre-activation of the transverse abdominal muscle on pain intensity in     adult patients diagnosed with chronic non-specific low-back pain compared to conventional     treatment in a primary care setting. The secondary aims of the study are to assess the     effects of a physiotherapeutic re-education program based on the pre-activation of the     transverse abdominal muscle on: (1) disability and limitations for the development of the     activities of daily living associated with LBP, (2) transverse abdominal muscle muscle     contraction, (3) to assess whether the resistance training parameters applied to older adults     are valid for young adults and (4) to determine whether the training protocols used for the     cervical spine could be extrapolated to the lumbar spine.   "
14360|NCT03097484|"     Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms     of Neonatal Abstinence Syndrome   "
14361|NCT03097471|"     Post-market prospective clinical study with a medical device. Data from patients that     routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented     with a follow-up time of 2 years.   "
14362|NCT03097458|"     A parental cancer diagnosis challenges the family's stability and the parent-child     relationship. It may impact the children's well-being, so that about one third of them     develop clinically relevant levels of psychological distress. Psycho-oncological family-based     counselling programs have been shown to elevate children's and parents' well-being. However,     there is still a dearth of familial health services in Switzerland, which has also been     recognized by the Swiss National Cancer Program (2011-2017).      This study aims to implement and evaluate a short-term family counselling intervention at the     Cancer Center of the University Hospital Basel. The primary objective of the study is the     enhancement of adjustment to the parental cancer diagnosis. The study seeks secondary to     determine the feasibility of the short-term counselling Intervention.   "
14363|NCT03097445|"     This study will perform a 5-year follow-up survey of participants in a randomized controlled     trial that evaluated the effectiveness of providing 5 weeks of free NRT (in the form of the     nicotine patch) by expedited postal mail without behavioural assistance to regular adult     smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier:     NCT01429129).   "
14364|NCT03097432|"     This prospective open multi-centre non-interventional study initiated to document the     up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic     asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel     pollen. The following up-dosing schemes are freely selectable: scheme A consists of an     up-dosing period of 12 days at the patient´s home using the standardized pollen extract in     three different solution strengths to reach the maximum dose; scheme B is performed only with     the highest solution strength at the physician's office within 2 hours; and the new scheme C     which is a regimen for initiation at the physician`s office and continuation at the patient`s     home also exclusively using the highest solution strength and takes 4 days. Data are     documented by physicians and in patients´ diaries.   "
14365|NCT03097419|"     The purposes of the study are to 1) study alterations in the metabolomic profile of patients     exposed to post-ischemic conditions and 2) study alterations in myocardial infarction size of     patients exposed to post-ischemic conditioning.   "
14366|NCT03097406|"     This study aims to investigate the shoulder function of patients with osteoarthritis or a     fracture of the upper extremity after surgery with the Global Unite shoulder system.      The majority of fractures of the humerus are non-surgically treated, but for the complex     cases where the fracture is irreparable (1), the treatment choice is a shoulder prosthesis     called a hemiarthroplasty. Hemiarthroplasty has been associated to less pain and more quality     of life , (2,3) but no difference in range of motion is reported when compared to     non-surgically treatment of complex humeral fractures. (2,3,4)      One of the important steps in surgery of a fractured humerus is the fixation of the bone     fragments in an anatomically correct position as previous studies have shown that     complications related to the fixation and healing of bone fragments occurred in 11 % of     patients treated with a hemiarthroplasty . The Global Unite hemiarthroplasty introduces a new     feature, which allows the surgeon to more closely attach the bone fragments.      Patients with osteoarthritis and fractures of the humerus will be included from two     hospitals, Herlev and Køge University Hospital. A total of 88 patients, 44 osteoarthritis and     44 fracture patients, are included. The patients will be followed two years after surgery and     will be seen a total of four times postoperatively, where the function of the shoulder will     be examined by questionnaires concerning shoulder function and quality of life, by a motion     examination and by x-ray. The outcome of these examinations will be compared to the     functional outcome of patients that have received different shoulder prostheses for the same     diagnoses at Herlev and Køge University Hospital. The patients will undergo two radiographic     scans after surgery, to determine whether or not bone fragments remain in an anatomically     correct position in the patients with a fracture of the proximal humerus. A special focus     will be on the function of the shoulder in patients with bone fragments that are not in an     anatomically correct position. Furthermore, complications and the need of reoperation were     registered during the two-year follow-up period.      The aims of this study is to        -  Determine the function of the shoulder in patients receiving the Global Unite prosthesis          due to either osteoarthritis or fracture of the humerus.        -  To compare these results with results from patients previously treated with a different          prosthesis designs        -  To determine the influence of the fixation of bone fragments in the postoperative          function in fracture patients.   "
14367|NCT03097393|"     The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction     of AKI septic patients in ICU.   "
14368|NCT03097380|"     An open-label study using positionemissiontomography (PET) to explore the binding of AZD2115     and Tiotropium to muscarinic receptors in the lungs in healthy volunteers after inhalation.   "
14369|NCT03097367|"     To investigate the relationship between post-operative bladder neck levels and urodynamic     parameters and their effect on urinary incontinence after laparoscopic radical prostatectomy     (LRP). Forty-eight consecutive patients undergoing LRP were retrospectively reviewed. All     patients had investigated by retrograde cystography after LRP and were grouped according     their bladder neck position: Level 0: bladder neck at or above the superior margin of the     symphysis pubis (SMSP), Level -1: bladder neck at <2 cm below SMSP, and Level -2: bladder     neck at >2 cm below SMSP. Urodynamic studies were carried out at baseline, 3 and 6 months     post-operatively. Early recovery of urinary continence was defined as no urine leakage or     only one pad/day used within 3 months after surgery. Demographic characteristics, changes of     urodynamic parameters and continence outcomes were analyzed.   "
14381|NCT03097211|"     The purpose of this study was to determine whether the administration of BIA 6-512 (25 mg, 50     mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when     administered in combination with a single-dose of immediate release levodopa/benserazide     200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a     single-dose of nebicapone 150 mg.   "
14382|NCT03097198|"     The purpose of this study is to determine whether plum-blossom needle is effective in the     treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.   "
14370|NCT03097354|"     Alcohol consumption is a prevalent behavior in Western societies, which may produce feelings     of happiness and sociability, but also increases the risk of individual and societal     detriments. A detailed knowledge about individual and region-specific alcohol consumption is     crucial in many aspects of health systems, from general practitioner's diagnostic evaluation     to decisions on health-care related fundings for prevention programs by legislative and     executive councils.      The assessment of alcohol consumption often consists of questions like What alcohol and in     which amount did you drink lately? which may be answered using a given list of prevalent     alcoholic beverages. With this study, the investigators want to contribute to the     understanding of psychological determinants in answering these questions. For example, it is     not yet fully understood, to which extend and why certain beverages are assigned to one of     several beverage groups. The investigators suspect that familiarity with specific beverages     as well as product names may influence this assignment.      In this online survey, which is open to any German-speaking alcohol user no matter how often     or how much alcohol one normally consumes, participants will be presented a list of common     beverages (e.g. Cuba Libre, Prosecco, Weizen) and asked to assign these beverages to one of     several beverage groups (e.g. whiskey, beer, sparkling wine).   "
14371|NCT03097341|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and     pharmacodynamics of xisomab 3G3 in healthy adult subjects.   "
14372|NCT03097328|"     This research study is investigating a drug as a possible treatment for metastatic renal cell     carcinoma. The intervention involved in this study is TAK-228.   "
14373|NCT03097315|"     Open-label safety study of suprachoroidal triamcinolone acetone injectable suspension in     patients with non-infectious uveitis.   "
14374|NCT03097302|"     To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior,     posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser     lens surgery.   "
14375|NCT03097289|"     The purpose of this study is to evaluate the quality of platelets collected on the Trima     Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.   "
14376|NCT03097276|"     Anastomotic fistula is the most feared complication after surgical resection of colorectal     cancer (CCR). It occurs in 6 to 15% of patients. Beyond the risk of death in the immediate     postoperative period, the pain that it induces, the resources required for its management,     the need for stomata with a negative impact on patients' quality of life and the prolongation     of hospitalization, it also has a now-recognized adverse effect on long-term survival.      The early detection of this complication may limit its impact. C-reactive protein (CRP) has     proved to be an early, reliable marker of the onset of infectious complications of colorectal     surgery.      However, the diagnostic procedure to implement in these patients is not at all codified,     since this population concerned by systematic CRP assay in the postoperative period is very     recent.      The procedures to implement in these patients so that they can obtain the maximal benefit of     an early diagnosis have not yet been established. An algorithm for the proactive clinical     management must be drawn up to be able to confirm or rule out the presence of a fistula as     soon as a high level of CRP is detected, and to propose a quick treatment to ensure that     patients benefit from this early diagnosis.   "
14377|NCT03097263|"     Despite the prevalence of chronic low back pain, functional symptomatology of this disease     remains poor and treatment decisions are based mainly on subjective data (importance and pain     tolerance). However, there are some experimental elements that involve objective assessment     of locomotor capabilities - at forefront objectives which the walking velocity in the     evaluation of this pathology in terms of severity of functional impairment. Recent evidence     suggest the effectiveness of physical rehabilitation program for improving patients     functional capacities and their reintegration in socio-professional life. This retrospective     study aims to quantify the evolution of the parameters collected during standardized walking     tests performed before and after rehabilitation program. These patients have systematically     carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the     beginning and end of their program. Furthermore, a maximal stress test on a treadmill was     performed before the program in order to detect any cardiovascular events and to allow the     personalization of the effort level required (target heart rate) during rehabilitation. In     this study the evolution of the comfortable and fast speed will be collected and compared     with the stress test data, and other measured parameters (functional score of Quebec, muscle     Tests Shirado and Sorensen).   "
14378|NCT03097250|"     This is a study about the relationship of brain biomarkers with neuropsychological     functioning in PKU. All participants will undergo MRI spectroscopy, will provide a blood     specimen and will receive neuropsychological testing.   "
14379|NCT03097237|"     The overall aim of this study is to investigate whether a diet rich in rye fiber from     wholegrain rye, compared to refined wheat, as part of a hypocaloric diet leads to larger     weight loss and lower body fat content after 12 weeks of intervention. Furthermore the study     will investigate the effect on appetite as a potential underlying mechanism for differences     in weight loss and body fat reduction.   "
14380|NCT03097224|"     Objectives To investigate the impact of tele-supervised prehabilitation on functional     capacity in frail colon cancer patients undergoing colorectal resection and to evaluate the     effects of prehabilitation on muscle strength and endurance, quality of life (QoL), executive     functions, fatigue and inflammatory and metabolic parameters.      Methods A randomized controlled trial will be conducted. Patients will be randomised into     either a prehabilitation group (PREHAB) or a control group. Prehabilitation group will     participate in a 4-week telerehabilitation before surgery while the control group will     receive usual care and World Health Organization recommendations on physical activity for     health before surgery. Program exercise will consist of three moderate-intensity aerobic and     resistance sessions per week. Subjects will have assessments at baseline, pre-intervention     and 8 weeks after surgery. The primary outcome will be functional capacity measured by using     the 6-min walk test. The secondary outcomes will be: physical measurements, QoL, level of     physical activity, executive functions, fatigue, body composition, blood test, energy     expenditure.   "
14383|NCT03097185|"     Analyze inflammatory markers and islet graft function through blood samples collected from     subjects with chronic pancreatitis who undergo total pancreatectomy with auto islet     transplantation.   "
14384|NCT03097172|"     This is a single centre observational study on the impact of change in patient position and     hence gravity, on physiological measurements in coronary arteries.      When patients present with heart attacks involving completely occluded heart arteries, there     are signs anecdotally and in literature that arteries sitting higher up with the patient     lying flat, receive less blood supply than arteries sitting lower down.      The investigators believe this effect is due to the pull of gravity on the flow of blood     through the heart arteries. If this is indeed the case, changing position from lying supine     (patient on their back) to lying prone (patient on their front) could reverse these     anatomical positions and change measurements obtained during a coronary angiogram. These     measurements include pressure and flow.   "
14385|NCT03097159|"     The investigator will compare Costoclavicular approach of infraclavicular block and     supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of     block.   "
14386|NCT03097146|"     After discharge from hospital, the current healthcare system in Germany allows considerable     flexibility (therefore complexity) of patient access and mobility between multiple care     providers in the community setting. The investigators believe this aftercare could be better     coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated     multidisciplinary care is a proven concept with proven benefits in both acute and     rehabilitation care provided in stroke units and neurorehabilitation centres. In this study,     the investigators postulate that a similar coordinated approach to care can be extended to     the phase after in-patient rehabilitation has ended (i.e. long-term management as opposed     to early supported discharge) for disabled patients with stroke living in the community.   "
14387|NCT03097133|"     The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram     (mg) compared with intranasal placebo in addition to comprehensive standard of care in     reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in     participants who are assessed to be at imminent risk for suicide, as measured by the change     from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24     hours post first dose.   "
14388|NCT03097120|"     Background: Heart disease is a major cause of illness and death in women. To understand     better the role of estrogen in the treatment and prevention of heart disease, more     information is needed about its effects on coronary atherosclerosis and the extent to which     concomitant progestin therapy may modify these effects.      Methods: The investigators randomly assigned a total of 309 women with angiographically     verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of     conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women     were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms     were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after     an average of 3.2 years of follow up.   "
14389|NCT03097107|"     To evaluate the safety and efficacy of Saroglitazar Magnesium 1, 2, and 4 mg in patients with     fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL.   "
14390|NCT03097094|"     A new male-specific dog-allergen-component has been found (Can f 5) which indicates possible     differences in allergic reactions to male and female dogs. This has not yet been tested in     real life.      The aim is to test if sensitization only to the male-dog specific allergen-component, Can f     5, results in a positive skin prick test (SPT) to male dog extract and not female dog     extract. In addition, the investigators want to investigate if allergic symptoms only occur     when exposed to the male dog extract by conjunctival provocation.   "
14391|NCT03097081|"     Rationale: There is no evidence in the current literature regarding the additional value of     an orthosis after surgically treated thoracolumbar spine fractures.      Objective: To assess whether an orthosis provides additional pain relief compared to no     orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is     difference in pain at six weeks post-operatively. Secondary objectives are pain at other     moments, pain medication used, pain related disability, quality of life, long-term kyphosis,     possible complications, hospital stay, return to work and subjective feeling on benefit or     disadvantage from the orthosis.      Study design: Randomized controlled intervention study, non-inferiority trial.      Study population: Dutch speaking patients presented at the VU university medical centre, 18 -     65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically treated     by posterior fixation.      Intervention: One group receives standard care and wears an orthosis after surgery for 12     weeks, to use when in vertical position. The intervention group does not wear an orthosis     after surgery.      Main study parameters/endpoints: Main study outcome is the difference in pain noted on the     NRS-score at six weeks, ≥ 2 (SD 2,5) change corresponds with a clinically significant change     in pain score.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The current guideline for postoperative care regarding dorsal stabilization of     spine fractures recommends the use of a post-operative orthosis. While patients generally     receive an orthosis for 12 weeks, individual surgeon's believes sometimes gives reason to     deviate from this guideline. This is founded by literature that increasingly questions the     use of orthoses in the conservative treatment of spine fractures. With the fracture     operatively stabilized, the orthosis mainly provides support of gesture and thereby     potentially results in pain relief and confidence for patients. On the other hand some     patients have a hard time weaning from the orthosis or report discomfort due to the device     and prefer not to use it. With subjects being randomized between the use of an orthosis or no     orthosis there is no additional risk. This is in part because it is hypothesized that there     is no difference in postoperative pain and there might be a lower risk of complications     related to the orthosis.   "
14392|NCT03097068|"     The protocol will measure a number of cytokines in addition to vascular endothelial growth     factor in response to 0.3mg Lucentis.   "
14653|NCT03093662|"     This is a prospective randomized cross over study of healthy volunteers comparing end-tidal     oxygen concentration among subjects undergoing continuous positive airway pressure     ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal     cannulas.   "
14394|NCT03097042|"     The embryologist will oad the embryos into the catheter at the right position, then the     catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm     away from the cervical external os.The embryos will be delivered by pushing the plunger of     the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down.      Study Group: The catheter will be pulled back slowly and without rotation with the plunger     still pushed forward.      Control Group: The catheter will be pulled back slowly with a 360°rotation with the plunger     kept pushed forward.   "
14395|NCT03097029|"     Patients with short bowel syndrome have a high mortality rate that is mainly attributed to     complications from central lines and long-term intravenous (IV) nutrition. There are few     medical therapies to date that improve gut absorption in patients with short bowel syndrome.     The primary objective of this study is to evaluate if absorption from the GI tract improves     in subjects with short bowel syndrome following therapy with pancreatic enzymes.   "
14429|NCT03096587|"     Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP     Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single     visit endodontic treatment and record postoperative pain afterwards.   "
14397|NCT03097003|"     OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing     study. The study will include a representative sample of approximately 250 patients with     moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin     apremilast treatment in accordance with the local label and reimbursement criteria. Patients     may be enrolled into the study up to 4 weeks after commencing the study treatment.      As this study is non-interventional, drug dosing and treatment duration will be at the sole     discretion of the treating dermatologist, in accordance with the local label and daily     clinical practice.   "
14398|NCT03096990|"     The study will include a representative sample of 150 patients with active Psoriatic     Arthritis (PsA) for whom the treating rheumatologist has decided to begin treatment with     apremilast. This study is non-interventional, drug dosing and treatment duration will be at     the sole discretion of the treating rheumatologist, in accordance with the local label and     daily clinical practice. APOLO is a national (Belgium), multicentre, prospective,     non-interventional, post-marketing study.   "
14399|NCT03096977|"     This study lies in the continuity of the study with identification number NCT02805634. It     will be performed on the same group of patients and will aim to assess the manual dexterity,     in order to better assign kinesitherapy treatments and increase the utilisation capacity of     the hand.   "
14400|NCT03096964|"     Objective: to assess by means of a randomized clinical trial the effects of eight weeks of     Nordic walking and free walking training on quality of life (QoL), static balance, dynamic     variability, self-selected walking speed (SWS) and locomotor rehabilitation index (LRI),     parameters of pendular mechanism [external (Wext), internal (Wint) and total mechanical work     (Wtot), Recovery (R), Cost of Transport (C)], Electromyographic parameters (Average signal     and co-contraction of the Anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL),     biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) muscles, heart rate     of exercise (HRexercise) - and the rate of perceived exertion (RPE), in sedentary elderly.   "
14401|NCT03096951|"     Objectives To investigate the impact of tele-supervised prehabilitation on functional     capacity in colon cancer patients undergoing colorectal resection for cancer and to evaluate     the effects of prehabilitation on muscle strength and endurance, quality of life (QoL),     executive functions, fatigue and inflammatory and metabolic parameters.      Methods A randomized controlled trial will be conducted. Patients will be randomised into     either a prehabilitation group or a control group. The prehabilitation group will receive     tele-supervised prehabilitation for 4weeks and telerehabilitation for 8weeks post-surgery     while control group will begin telerehabilitation only after surgery for 8weeks. Patients     will care with an enhanced recovery pathway. Telerehabilitation pre and post-surgery will     consist of three moderate-intensity aerobic and resistance sessions per week. Subjects will     be assessed at baseline, pre-intervention, post-intervention and post-rehabilitation. The     primary outcome will be functional capacity measured using the 6-min walk test. The secondary     outcomes will be: physical measurement, quality of life, level of physical activity,     executive functions, fatigue, body composition, blood test, energy expenditure.   "
14403|NCT03096925|"     This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT)     self-help intervention designed for non-cardiac chest pain patients, and compare     effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial     (RCT).   "
14404|NCT03096912|"     The purpose of this study is to determine whether ribociclib are effective and safe in the     treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).   "
14405|NCT03096899|"     The primary objective of this study is to estimate overall survival in patients only     receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal     carcinoma. The primary efficacy outcome is overall survival, defined as the time from the     date of the radiographic scan demonstrating disease progression post available treatments     (time of origin, T0) to death from any cause.   "
14406|NCT03096886|"     The investigators will recruit a total of 100 participants: 60 with Major Depressive Disorder     (MDD) from the Outpatient Clinics of the University of Pennsylvania and 40 matched comparison     participants. MDD participants will all receive computer-augmented skills training with the     Good Days Ahead (GDA) protocol. Half of the MDD participants initially will be randomized to     Depression Care Management (DCM) (supportive management as a placebo comparator for CCBT)     and subsequently will receive CCBT treatment. All participants will receive functional     magnetic resonance imaging (fMRI) scanning at baseline and again following either 8 weeks of     CCBT or 8 weeks of DCM. Brain activity will be compared between MDD and controls at baseline     and between CCBT-treated vs DCM-treated at 8 weeks. At the conclusion of 8 weeks the     DCM-treated participants will receive an 8-week course of CCBT and will have a 3rd fMRI scan     at the conclusion of CCBT, allowing within-subject comparison of CCBT vs DCM treatment     effects.   "
14407|NCT03096873|"     The purpose of the study was to observe therapeutic effects of combined resistance and     aerobic exercise training (CRAE) on hyperinsulemia in obese adolescent girls. Forty obese     adolescent girls (14±1 years) participated in this study. The participants were randomly     separated into two groups; no-exercise group (n=20) and exercise group (n=20). The exercise     group performed 12 weeks of CRAE.   "
14408|NCT03096860|"     The purpose of the current study is to investigate in a prospective randomized cross-over     trial, the impact of alcohol versus a placebo drink on smoking behavior and topography     (duration and frequency of puffing), abuse liability, and toxicity. It is hypothesized that     drinking alcohol before smoking will be associated with longer puffs and shorter duration     between puffs and greater abuse liability and toxicity.   "
14409|NCT03096847|"     A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety     of treatment with ribociclib (LEE011) plus letrozole in women and men with HR+, HER2-negative     advanced or metastatic breast cancer.   "
14410|NCT03096834|"     The purpose of this study is to determine if AMG 334 is effective in treating migraines in     patients who have unsuccessfully failed other preventive migraine treatments.   "
16095|NCT03074812|"     This study evaluates the effect of transcranial direct current stimulation (tDCS) on     non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms.     Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment     sessions.   "
14411|NCT03096821|"     Patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive     lymphoma harboring an activating genetic alteration (gene mutation, gene fusion) or drug-able     biomarker / activated signal transduction pathway and resistant to any approved treatment     modality will be eligible for this study.      The investigators aim to combine DNA sequencing-based molecular profiling with an ex vivo     high-throughput drug screening strategy. For the latter method, viable cells are obtained     from the individual patient's lymphoma or leukemia in order to determine i)the expression of     relevant therapeutic target molecules and ii)the ex vivo response of the patient's cancer     cells to a panel of agents with anticancer activity. In addition, analysis of tumor stroma     cells will provide information about the differential target expression and cellular     sensitivity aiming at the evaluation of a therapeutic safety window. Thereby, biological     material will have to be accessed within 4 weeks before onset of individualized treatment     (real-time biopsy). Bioinformatic data-management based on a Bayesian statistical approach     will support individualized treatment decisions in this controlled clinical approach.   "
14412|NCT03096808|"     The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck     cancer patients are comparable to historical controls in head and neck patients undergoing     standard intensity-modulated radiation therapy (IMRT) without ART.   "
14413|NCT03096795|"     This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the     safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple     doses of MEDI3506.   "
14414|NCT03096782|"     The goal of this clinical research study is to learn if giving 1 unit of expanded cord blood     combined with 1 unit of non-expanded cord blood to a patient with leukemia or lymphoma can     help the transplant to take faster. The safety of this combination will also be studied.     Chemotherapy and/or 1 dose of radiation therapy will also be given before the transplant.   "
14415|NCT03096769|"     This study is designed to answer if an ergonomist can configure a daVinci robot console to     improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they     are tailored to their individual body type. Measurements will be taken at the time of console     configuration.   "
14416|NCT03096756|"     A Phase 1 study will test the safety, tolerability and pharmacokinetics of a single dose of     GC4702 when given as an oral tablet. This study will compare capsules containing a dry powder     or gel suspension of GC4702 when given orally to a similar drug called GC4419 which will be     given as an intravenous infusion. This study will also assess the effect of food on the     GC4702 effects.   "
14417|NCT03096743|"     Investigators will compare magnetic resonance (MR) elastography measurements to other forms     of noninvasive methods of detecting raised intracranial pressure, including optical coherence     tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect     signs of raised intracranial pressure on magnetic resonance imaging (MRI).   "
14418|NCT03096730|"     To explore and compare antihyperalgesic effects of Dexmedetomidine,Nalmefene,and a     combination of both received before anesthesia induction.      To evaluate and examine the incidence of adverse effects with the purpose of selecting the     optimum dose.   "
14419|NCT03096717|"     Chronic intestinal inflammation produce dysplasia more frequently than the normal population.     The therapies protect against these changes, but do not rule out dysplasia. It is not known     the effect of different therapies protection.   "
14420|NCT03096704|"     Vitamine d dosage in important to define nutritional status and bone metabolism. For patients     with intestinal disorders it is important to establish the intestinal absorptive function.      It is important to establish the absorption of vitamin D which correlate with different     biological activity and bone metabolism, immune function and the communication between the     cells.   "
14421|NCT03096691|"     Prematurity is the most important cause of obstetric morbidity and mortality. Health centers     and obstetricians are trying to reduce the preterm birth rate by taking into account the     permanent effects of premature birth on human life in the early and long term.      The most effective solution of preterm delivery is to determine the patients entering the     risk group and to prevent preterm labor by putting the correct diagnosis at the right time.     Recently, there have been studies on the efficacy of pessary practice in preventing preterm     birth, but with the positive results of these studies, there has been hope for early birth     prevention as well as other treatments.      The aim of this study is; To assess the effectiveness of pessary use in patients with high     risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and     with a history of cervical insufficiency.   "
14422|NCT03096678|"     The investigators sought to evaluate the morphological and functional changes, risk     stratification and prognosis of patients of participants with compete left bundle branch     block (CLBBB).      The conduction of this study was largely due to the increased clinical requirement, which     reflected the increased awareness among physicians of heart failure due to asynchronous     cardiac function caused by CLBBB. The investigators also aim to figure out the time point or     CMR parameters for cardiac resynchronization therapy in patients with CLBBB.   "
14423|NCT03096665|"     This study aimed to evaluate the correlation between the point of care blood analysis     obtained from skin puncture blood and conventional blood analysis obtained from venous and     arterial blood.   "
14425|NCT03096639|"     A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy     System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have     failed at least two weaning attempts. The goal is to strengthen and rehabilitate the     diaphragm to liberate the patient more quickly from mechanical ventilation.   "
14426|NCT03096626|"     This study assesses the association of depression symptoms and iron metabolism in patients     undergoing hemodialysis.   "
14427|NCT03096613|"     Based on accumulating evidence showing that hypothyroid status is associated with poor     prognosis among heart failure (HF) patients, the study is designed to evaluate whether     replacement treatment with levothyroxine could have beneficial effects on patients with HF     and subclinical hypothyroidism. The study is a prospective, randomized, parallel-group trial     to assess the efficacy and safety of levothyroxine replacement on evidence-based HF standard     therapy in stable chronic heart failure patients with subclinical hypothyroidism.   "
14430|NCT03096574|"     Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and     bronchiolitis) in young children, and is a major cause of admission to hospital and childhood     death worldwide. One possible way to protect the mother and young infant from RSV infection     is a vaccine given to women during pregnancy (maternal vaccination), which would pass     protection to their unborn child. This may help to prevent RSV in the child's first few     months of life when they are most vulnerable to infection. With RSV vaccine candidates in the     pipeline, this study aims to pre-emptively gauge the knowledge of RSV and potential     acceptability of such vaccines amongst pregnant women and healthcare staff working in     midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being     involved in hypothetical future research trials.      The investigators propose to undertake a questionnaire-based study of randomly selected     pregnant women and healthcare staff (over 16 years of age) at four English teaching     hospitals. Pregnant women attending for ward reviews or antenatal clinics will approached and     asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare     staff will be approached in person, or via email, and asked to complete a slightly different     questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical     software, the investigators hope to identify factors that might affect patients'     understanding of RSV and attitudes to being involved in hypothetical future trials and     receiving the RSV vaccination   "
14431|NCT03096561|"     Serum Potassium Rate (PR) is a key indicator for medical management of patients with     accidental hypothermia particularly for hypothermia related cardiac arrest (CA).      Experts recommend a cut-off value for PR of 12 mmol/l for all hypothermic victims and 8     mmol/l for avalanche casualties. Any patient presenting a PR lower than the cut-off value     should be considered for Extracorporeal Rewarming. This therapeutic strategy is vital for     patient survival.      However, there is no consensus about what type of vessels should be punctured in order to     obtain an accurate potassium rate and what type of measurement technics should be used to     measure this potassium rate.      The investigators hypothesize that potassium rate in these patients will differ by 1 mmol/l     in blood samples collected from a peripheral vein in contrast to a central vein.      The investigators study is a prospective observational, multicentre study.   "
14432|NCT03096548|"     Over 3.5 million cases of non-melanoma skin cancers occur annually and melanoma rates have     doubled in the last 30 years, burdening the nation's health system. Klein Buendel, Inc. (KB)     proposes to develop Sun Safety INK! (SSI!), a skin cancer prevention program targeted to     clients of licensed tattoo studios because tattoo aftercare recommendations can include sun     protection for tattoos, and studios offer an opportunity to reach younger adults who are     significantly more likely to sunburn and less likely to practice sun safety. The study will     assess the effectiveness of SSI! at (1) increasing full-body comprehensive sun protection     practices; (2) decreasing sun burning and tanning; and, (3) decreasing positive attitudes     regarding tanning and tanning attractiveness.   "
14433|NCT03096535|"     This study investigates cold-induced brown fat activation assessed using PET/MR scans.     Subjects will participate in an acute cooling intervention day and a thermoneutral     intervention day with PET/MR scans on both days. A secondary purpose is to make a validation     of an infrared thermography camera by comparison of skin temperatures and SUV of the     supraclavicular brown adipose tissue.   "
14434|NCT03096522|"     Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of     two groups; the first group will receive topical phenytoin therapy postoperatively and the     second group will not receive such topical treatment.   "
14435|NCT03096509|"     Innovations aimed at improving new patient identification, diagnosis, nonpharmacological     treatment, supported self-management, and remote monitoring, together with new methods of     clinical support could improve outcomes in patients with respiratory disease. The     Investigators have developed a model of care incorporating key innovations for patients with     asthma, COPD and undifferentiated breathlessness. This service is being implemented within     Wessex CCGs. The investigators will assess whether the implementation of the service is     effective, and how it can be adjusted, in addition to introducing innovations to assess     whether the expected benefits for patients are realised.   "
14436|NCT03096496|"     This is a prospective and international observational study run by the GIMEMA. All data will     be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients     reported outcomes will be collected using internationally validated questionnaires.   "
14437|NCT03096483|"     The purpose of the study is to collect survey data on the use of the OEC Elite Mobile     Fluoroscopy System based on the routine clinical use of the device.   "
14438|NCT03096470|"     The purpose of this study is to compare the efficacy of closed reduction with anesthesia and     no anesthesia for developmental dislocation of the hip < 6 months   "
14439|NCT03096457|"     This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb)     to placebo for L braziliensis in Bolivia.   "
14498|NCT03095690|"     Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease.     Its association with osteroporosis and fragility fracture is now clearly demonstrated, but     the determinants of this osteoporosis are yet to be explained. Our aim was to study factors     associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia     and radius in IPD.   "
14440|NCT03096444|"     The purpose of this study is to examine the antipruritic efficacy of topical ketamine,     amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine     (hereafter referred to as KeAmLi) using non-histaminergic itch provocations in healthy     volunteers. The primary outcome is itch reduction (AUC) between the vehicle and active     treatment (KeAmLi-combo). Secondary outcomes include modality-specific analgesic properties     of the topically applied ketamine, amitriptyline, lidocaine, and KeAmLi-combo to controlled     quantitative thermal and mechanical stimuli, which can improve our understanding of the     mechanism of action of these substances in the context of topical therapy.   "
14442|NCT03096418|"     The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN)     in tumors and this is lethal to tumors that have pre-existing CIN.      Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as     standard infusions on days 1, 8, and 15 of a 1-day cycle. Participants will continue with     paclitaxel for cycles 2-4 prior to surgery.   "
45822|NCT02685852|"     The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing     episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.   "
14443|NCT03096405|"     Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during     bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in     beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant     to the methicillin ( SARM).      With the implementation of the MALDI-TOF, it is now possible to identify the origin     responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set     up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the     vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased     the average duration of stay and a more important rate of relapse.      The PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of     the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.   "
14444|NCT03096392|"     Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability     and efficacy study   "
14445|NCT03096379|"     It is clinically challenging to differentiate Crohn's disease from gut tuberculosis     especially in regions endemic of tuberculosis infection. The investigators plan to perform     magnetic resonance enterography (MRE) who presented to our hospital in Shenzhen, China for     new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain     diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on     colonoscopy. MRE findings will be independently interpreted by two radiologistsThe role of     MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.   "
14446|NCT03096366|"     The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR     training compared to PT alone (without BFR training) after ACL reconstruction in patients who     require extended limited weight bearing through assessment of patient reported outcomes and     functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of     quadriceps muscle cross-sectional area, strength, and function while also improving early     clinical and functional results.   "
14447|NCT03096353|"     Background:      Medicines called opioids are used to treat pain. The body also produces opioids. These are     called endorphins. Researchers want to learn more about how these natural opioids work. This     might lead to new therapies for conditions like depression, anxiety, and chronic pain.      Objective:      To determine how opioids affect how pleasant or unpleasant it feels when the skin is touched,     compressed, or heated.      Eligibility:      Healthy right-handed adults ages 18 50.      Design:      Participants will be screened under another protocol.      Participants will have 2 study visits with the same procedures, at least 1 day apart. Each     visit will last 3-4 hours.      Participants will wear shorts or change into scrubs so researchers can test on their legs.      Participants will answer questions and have urine tests.      Participants will have a brain magnetic resonance imaging (MRI) scan. The scanner is a metal     cylinder in a strong magnetic field. Participants will lie on a table that slides in and out     of the cylinder. A device called a coil will be placed over the head.      During MRI, participants will have sensory testing. They will get several types of touch to     the calf of the leg. These include gentle brushing of the skin, gentle compression of the     calf with an inflation sleeve, and heat stimuli.      Participants will have an intravenous line placed each day. They will get naloxone 1 day and     saline the other day. Participants will not be told which they get. Naloxone is a drug that     blocks opioid receptors.      The MRI and sensory testing will then be repeated.      After each stimuli block, participants will rate the sensations as well as their mood and     calmness/anxiety.   "
14448|NCT03096340|"     IT141 is a novel nanoparticle formulation of SN-38, the active metabolite of irinotecan, and     is intended to deliver more drug to the tumor with reduced toxicity on normal tissues. The     study is designed to determine the maximum tolerated dose (MTD) of IT-141, and to investigate     pharmacokinetic (PK) parameters and possible pharmacodynamics (PD) relationships. Patients     will also be monitored for any response to therapy.   "
14449|NCT03096327|"     • To compare the quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.   "
14450|NCT03096314|"     This study aims to evaluate the effect of early administration of high-dose vitamin D3 in     reducing all-cause, all-location mortality in vitamin D deficient patients at high risk for     ARDS. Patients will be screened for vitamin D deficiency (<20 ng/mL). Only patients screened     as vitamin D deficient will be randomized. Half of the vitamin-D deficient patients will be     given a high-dose of vitamin D3 and the other half will be given a placebo.   "
14451|NCT03096301|"     The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment     and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with     TMD.   "
14480|NCT03095924|"     The main objective of this study is to compare the interpretation of health news items     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,     distortion of research results). The news items which reported those studies evaluating the     treatment effect, having highest number of spin in the headline and text and received high     online public attention will be selected. Spin will be deleted and will rewrite the news     items without spin. This sample of news items reporting results of RCTs with and without spin     will be interpreted by French-speaking patients.   "
14452|NCT03096288|"     Clopidogrel is the most widely used P2Y12 receptor inhibitor and is the only agent of this     class currently recommended in patients with stable coronary artery disease (CAD) undergoing     PCI, and for the treatment of stroke or PAD. Pharmacodynamic (PD) studies have shown that     approximately 30-40% of patients experience high on-treatment platelet reactivity (HPR) while     receiving clopidogrel treatment. Importantly HPR status has been strongly associated with an     increased risk of ischemic events. Multiple approaches have been advocated to reduce HPR     rates. In a previous study treatment with high-dose atorvastatin in addition to double-dose     clopidogrel reduced platelet reactivity significantly more than double-dose clopidogrel alone     in statin-naïve patients with stable CAD and HPR. To date, the exact biological mechanisms     involved in the statin modulation of platelet function are not fully understood, although     likely attributed to both its lipid-lowering and non-lipid-related effects.      Evolocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9     (PCSK9). The use of evolocumab plus standard therapy, as compared with standard therapy     alone, significantly reduced the incidence of cardiovascular events. Whether the reduction in     cardiovascular events is simply due to LDL reduction or might be related to other mechanisms     is currently subject of investigation. Although LDL reduction with statin therapies has been     associated with reduction in platelet reactivity, to date the effects on platelet aggregation     of adjunctive lipid lowering with evolocumab has not been explored.      The aim of the present study is to investigate the effects of evolocumab in addition to     statin therapy on HPR rates and platelet reactivity in patients with atherosclerotic     cardiovascular disease (ASCVD) and HPR while on clopidogrel treatment.   "
14463|NCT03096145|"     This pilot study is being done to adapt an effective 1 session phone coaching intervention     for nonsmoking support persons to a low income population. This study will also pilot new     intervention components including text messaging and health incentives. The goal of the     intervention is for support persons to prompt their smoker to use quitline services. To see     if these methods are effective, smokers in this study will be asked to complete assessments     about their quit attempts and smoking status. The study will also evaluate if the smokers use     quitline services or not. The preliminary findings will be used to provide data for an R01     NIH grant submission.   "
14453|NCT03096275|"     Takayasu's arteritis(TAK) is a rare systemic vasculitis which can cause ischemia or     inflammation of the involved organs and increase the overall mortality rate.The traditional     treatment of TAK is primarily empirical. The most commonly used drugs for treating active TAK     are glucocorticosteroids(GC) and immunosuppressants. However, the genital toxicity of CYC has     limited its long term use. In a pilot study carried out by the principal investigator of this     study has shown that mycophenolate mofetil(MMF) combined with MTX is effective and with few     adverse effects. The purpose of this prospective open-label study is to compare the efficacy     and safety of GC+MMF+MTX with GC+CYC followed by GC+AZA for the treatment of active TAK. 150     patients with active TAK will be recruited and randomized in a 2:1 ratio to GC+MMF+MTX group     and C+CYC and AZA group. Patients were followed for 52 weeks for efficacy and safety     assessment.   "
14454|NCT03096262|"     The purpose of this study is to advance upper limb RMTR for patients recovering from stroke     by empowering them through active science participation. By varying the tasks' features and     affordances of a platform that combines a low-cost haptic device on one hand, and an online     citizen science platform on the other, investigators will evaluate different strategies for     social telerehabilitation. the two fundamental modes of social interaction — competition and     cooperation — in addition to a control condition. Specifically, citizen science activities     will be performed by competing, cooperating, or isolated users, and their rehabilitation     effectiveness examined. Such effectiveness will be measured by (i) participants'     rehabilitation performance (inferred from sensorimotor data acquired through the platform and     directly quantified by a supervising therapist); (ii) participants' motivations to contribute     (measured through surveys administered online); and (iii) participants' emotional well-being     and sense of self-esteem (measured through online surveys).   "
14455|NCT03096249|"     Oxytocin (OT) is a neuropeptide that acts as a neurotransmitter and neuromodulator in the     brain. Previous studies have shown that intranasal administration of OT improves social     cognition and behavior (e.g. emotion recognition). In the current study, we want to gain more     insight into the underlying mechanisms by which OT influences emotion recognition. More     specifically, we will investigate whether intranasal administration of OT enhances the     salience of social (compared to non-social) information and whether it increases the neural     sensitivity for subtle socio-emotional cues, by recording scalp electroencephalography (EEG)     during Fast Periodic Visual Stimulation (FPVS).   "
14456|NCT03096236|"     Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial     tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle     biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear.     Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection     usually is difficult, associated with high risk of complications and sometimes is not     feasible. Surgical resection is also associated with a risk of complications and often     refused by the patients. With the developement of the gFTRD-System gastric SET can now be     resected endoscopically. The advantage of this technique is the complete resection and a     full-thickness resections specimen for are definite histology.   "
14457|NCT03096223|"     The objective of this study is to evaluate the safety and tolerability of multiple     intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.   "
14458|NCT03096210|"     This study evaluates the radiographic, histological and clinical comparisons of the     completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation     procedure.   "
14459|NCT03096197|"     The overall aim of this project is to assess the effect of combining transcutaneous     lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone     without stimulation on walking recovery.   "
14460|NCT03096184|"     This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus     tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma     of head and neck. The primary purpose of this study is to evaluate the efficacy of apatinib     mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic     squamous cell carcinoma of head and neck   "
14481|NCT03095911|"     The main objective of this study is to compare the interpretation of health news items     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,     distortion of research results). The news items which reported those studies evaluating the     treatment effect, having highest number of spin in the headline and text and received high     online public attention will be selected. Spin will be deleted and will rewrite the news     items without spin. This sample of news items reporting results of RCTs with and without spin     will be interpreted by English-speaking population.   "
14461|NCT03096171|"     This protocol proposes a well-being program, delivered through an application for mobile     devices, based on meditation and positive psychology principles such as human development,     the improvement of virtues, quality of life and well-being. The investigators hypothesize     that this program offered in mobile application may promote well-being and reduce stress     related problems in the participants. Objectives: To evaluate the effectiveness of a     well-being program delivered through an application for mobile devices in a sample of high     school students. Methods: Sixty high school students will be recruited. The participants will     be randomized in two groups of 30 participants each one, half of them in the control group     (GC) and the other half to the intervention group (GI).   "
14462|NCT03096158|"     Background: Coronary artery bypass grafting (CABG) due to coronary artery disease (CAD) is     one of the main surgical procedures performed in the area of cardiology. Individuals     undergoing CABG present sarcopenia, decreased muscle strength of the lower limbs, decreased     respiratory muscle strength and dyspnea due to immobility in the bed and the inherent     conditions of the disease itself. Cardiorespiratory rehabilitation techniques are rarely used     with measurement in hospitals and can greatly favor an early and effective reestablishment to     this population in several parameters. Objective: To evaluate the effect of functional     electrical stimulation (FES), ventilatory muscle training (TREMVEN), early aerobic training     (AERO) and isometric handgrip training (ISO) on the functional capacity, endothelial function     and cardiac parameters of individuals undergoing CABG. Methods: In a randomized clinical     trial, volunteers will be allocated into four groups: EEF, TREMVEN, AERO or ISO in the     preoperative period of CABG. After 48 hours (postoperative midway) of the surgery, the     protocol will begin until after hospital discharge. The endpoints evaluated will be:     functional capacity, respiratory muscle strength, systolic and diastolic function, arterial     endothelial function, inflammatory profile and plasma levels of vascular endothelial growth     factor (VEGF). Scientific contributions: Phase 1 cardiorespiratory rehabilitation with     alternative interventions may provide an increase in functional capacity, strengthening of     respiratory muscles, improvement in cardiac and endothelial functions, as well as increased     systemic VEGF levels (myocardial revascularization) and improvement of the inflammatory     profile, effectively forwarding the individuals to the rehabilitation phase 2.   "
14464|NCT03096132|"     The objective of the study is to evaluate whether a less intensive intervention, Guided     Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based     Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness     of both treatments will also be compared.   "
14465|NCT03096119|"     Blood pressure variability (BPV) is being increasingly recognized as an important influence     on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events.     However, in Asia there is a current lack of awareness of BPV and its significance on patient     outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP)     monitoring in managing hypertension patients and uncertainty on how best to integrate it into     clinical practice.      Therefore, we conduct Asia BP@Home study to assess HBP control status in each Asian country     and develop an Asian consensus and Asia-specific treatment for hypertension.   "
14466|NCT03096106|"     Airway pressure-time (P-t) curve and stress index (SI) assessment have been proposed to guide     the mechanical ventilation settings and minimize ventilator-induced lung injury.   "
14467|NCT03096093|"     This study evaluates four different doses of ACIT-1 for safety and for the ability to raise     effective anti-cancer immune responses in patients with pancreatic and other late stage     cancers. Approximately half of the patients will have pancreatic cancer and the other half     will have other late stage cancers.   "
14468|NCT03096080|"     This study evaluates safety and tolerability of a single ascending dose of a tesevatinib     liquid formulation administered to pediatric subjects with ARPKD.   "
14469|NCT03096067|"     The purpose of this project is to investigate if the magnitude of a loading based 12 weeks     rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon     structure and function.      The investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a     more positive clinical outcome, tendon structure and function in patients with patellar     tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise     volume is equal in both groups.   "
14470|NCT03096054|"     This clinical study is looking at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult     patients with advanced solid tumours. The main aims are to find out the maximum dose of     LY3143921 hydrate that can be given safely to patients, more about the potential side effects     and how they can be treated   "
14471|NCT03096041|"     Auriculotherapy is a complementary medicine, with few side effects, without contraindication,     inexpensive and not very restrictive.Its efficacy has been found in several tests especially     for the treatment of intraoperative pain. It remains more controversial in other indications.     Evaluation of the value of auriculotherapy is often difficult because of the methodological     limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed     to improve the articular pains of patients treated by AA. This Phase III study aims at     validate this approach.   "
14482|NCT03095898|"     The objective of this study is to compare the effectiveness of acupuncture versus Sham     acupuncture in reducing patient's discomfort and pain during colonoscopy with a standard     sedation protocol. This will be objectively measured by the reduction in the amount of     analgesia used as well as the time spent in the recovery room.   "
14483|NCT03095885|"     Identify individuals with greater absorption of oxalate based on increase in urinary oxalate     excretion in response to a controlled oxalate-rich test meal.   "
14499|NCT03095677|"     The inclusion of short periods of apnea (several seconds) during exercise (i.e. dynamic     apnea) induces a significant decrease in blood oxygenation and muscle tissue. To date, the     immediate effects (acute apnea) of this decrease in the quantity of oxygen available at the     muscle and brain level are poorly understood. Moreover, a physical training during which     these short periods of apnea (chronic apnea) would be included could lead to physiological     adaptations and to improvement in physical performance similar to those obtained during     altitude training.      The purpose of this study is to evaluate the effects of acute dynamic apnea on metabolism.   "
49656|NCT02635685|"     A cluster randomised study in the primary care setting to evaluate a electronic clinical     decision tool for stroke prophylaxis in patients with atrial fibrillation.   "
14472|NCT03096028|"     Common mental disorders (CMD) such as Depression, contributes significantly to the global     burden of disease. Fetal exposure to adverse intrauterine environment mediated by life course     factors can enhance risk of non-communicable disease in later life. Maternal micronutrients     such as Vitamin B12 and folate play an important role in early fetal development through     their effect on one carbon metabolism.      Vitamin B12 deficiency is common in Indian women; however guidelines recommend only iron,     folic acid supplementation during pregnancy. This study aims to investigate effects of     maternal B12, folate during pregnancy on mental health and neurocognitive outcomes in     offspring during adulthood.      The Pune Maternal Nutrition Study(PMNS) birth-cohort(n=762) was established in 1993 at the     Diabetes Unit of KEM Hospital Pune with well characterized serial data and archived     biological samples. The subjects of the cohort are now in age range of 20-22 years and this     provides an opportunity to examine the proposed objectives.      Key objectives:      To examine the specific association between maternal vitaminB12, folate, homocysteine levels     at 18 & 28 weeks of gestation and risk for CMD, neurocognitive outcomes.      Examine the causality of this association by Mendelian randomisation using genetic     determinants of vitamin B12 and homocysteine.      Design and analysis:      Consenting members of the birth cohort of PMNS (n=690) will be recruited after ethics     approval.      Following cross-sectional outcome measures will be measured Neurocognitive functions: using     standardized neuropsychological battery Brain imaging for Structural and functional magnetic     resonance imaging (MRI). Temperament-character dimensions (TCI):140 item short TCI-R.     Structured clinical interview for CMD, Diet, physical activity, High-risk behaviors, Early     life stress.      Serum Brain Derived Neurotrophic factor (BDNF), Insulin like growth factor (IGF-1) from serum     archived at 6,12 & 18 years.      Longitudinal methods and multivariate regression analysis would be used to investigate the     hypothesized associations. Path analysis will be used to generate pathways of evolution of     the abnormalities.      Causality of the associations will be assessed by Mendelian randomization analysis     (triangulation and instrumental variable analysis) using maternal genetic determinants of     vitamin B12 and homocysteine   "
14473|NCT03096015|"     An intensive, interdisciplinary treatment program was administered during the summer as part     of regular clinic services in the Aphasia Resource Center (ARC) at Sargent College. This     program was run program as described for three years. Not more than six native English     speakers with mild or moderate profiles of aphasia and multidisciplinary rehabilitation needs     (OT,PT, SLP and nutrition) were recruited from the Boston community to participate in an     intensive interdisciplinary treatment program for four weeks during the month of June 2013.     The program consists of approximately six hours of interdisciplinary treatment each day, five     days per week over a four-week interval. Treatment is individualized using current     evidence-based treatment approaches, which are commonly accepted protocols in clinical     practice and will be administered by clinical faculty and staff from Speech-Language and     Hearing Sciences, Occupational Therapy (OT), Physical Therapy (PT), the Center for     Neurorehabilitation and Nutrition. Segments of these types of treatments are available for a     small fee as part of our service in the Aphasia Resource Center; however, this comprehensive,     interdisciplinary program is not available of this research study.      Approximately 30 hours of therapy per week are provided -- 6 hours per day over 5 days     consisting of Speech-language Pathology, Physical Therapy, Occupational Therapy, and     Nutrition Counseling.   "
14474|NCT03096002|"     The purpose of this study is to address whether inactive individuals with prediabetes who     take part in the Small Steps for Big Changes program, which is a 3-week supervised exercise     and lifestyle change program with brief counseling, will be more adherent to regular exercise     one year after program completion compared to before they took part in the program.   "
14512|NCT03095508|"     The purpose of this study is to evaluate no less therapeutic efficacy and safety of the Angal     S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN®     FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) in treatment of     patients with uncomplicated acute infectious and inflammatory diseases of the pharynx,     accompanied by a sore throat.   "
14475|NCT03095989|"     The psychological impact of ALS on both patients and caregivers is high and affects their     quality of life (QOL). However, there is minimal research about psychological interventions     to improve QOL in the ALS scientific literature.      Recent advances in clinical treatments aimed at improving the health of people with chronic     disorders are based on the concept of mindfulness. Mindfulness can be defined as a flexible     state of mind resulting from the simple act of actively noticing new things, as opposed to     mindlessness, the human tendency to operate on autopilot.      Preliminary data suggests that mindfulness may promote a better QOL for people with ALS and     their caregivers. The investigators also found that a mindful attitude was associated with     slower disease progression.      This project's goal is to develop an innovative, web-based online mindfulness training     program and intervention, customized for people with ALS and their primary caregivers. It is     an active learning intervention, with cognitive exercises and lectures that increase     participants' mindfulness. The efficacy of this program for improving QOL, and for reducing     anxiety and depression in people with ALS and their caregivers, will be tested with a     randomized clinical trial. Assessments immediately post-treatment as well as 3 and 6 months     after recruitment will be conducted, comparing subjects undergoing the mindfulness     intervention to a control group.   "
14476|NCT03095976|"     The purpose of this pilot project is to evaluate the efficacy of application of     Amnion-Chorion allograft membrane on the root surface of periodontally diseased teeth in     conjunction with bone substitute covered by Amnion-Chorion allograft in a combination GTR     treatment of periodontal intrabony and furcation defects.   "
14477|NCT03095963|"     A prospective, randomized, single-blind, controlled, investigator-started clinical trial was     carried out. Patients with primary hypothyroidism were randomly assigned to the study     (VSL#3®+ LT4) and the control group (LT4). A two months treatment phase was followed by two     months of follow-up. Clinical examination, blood tests for thyroid function and for     peripheral tissue markers of thyroid hormones effect were performed monthly for 4 months. LT4     dose adjustments were performed during the study when necessary.   "
14478|NCT03095950|"     The main objective of this study is to compare the interpretation of health news items     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,     distortion of research results). The news items which reported those studies evaluating the     treatment effect, having highest number of spin in the headline and text and received high     online public attention will be selected. Spin will be deleted and will rewrite the news     items without spin. This sample of news items reporting results of RCTs with and without spin     will be interpreted by French-speaking population.   "
14479|NCT03095937|"     The goal of this study is to evaluate fetal myocardial performance in patients with heart     diseases in comparison to normal pregnant patients.   "
14495|NCT03095729|"     The purpose of the study is to measure the negative cognitive consequences of the ventilation     under pathological or experimental cortical drive to breath.   "
14484|NCT03095872|"     In the field of dermatology the healing process and therefore the success of a laser     treatment are strongly determined by an appropriate postoperative treatment of the     laser-treated skin. The manufacturer of CO2 laser systems recommends the application of     Vaseline postoperatively to protect the treated tissue from air exposition until encrustation     of the laser-treated skin decreases (usually after 7-14 days). An alternative to Vaseline     could be Bepanthen® Wund- und Heilsalbe (Bayer). It contains the active ingredient     pro-vitamin Dexapanthenol, which is widely used in dermatology therapy. The product helps to     stabilize the protective barrier of the skin, to reduce the skin irritation, to stimulate the     skin regeneration and to promote the wound healing. In an in-vitro study Bepanthen® Wund-     und Heilsalbe triggered wound closure significantly faster compared to Vaseline. In this     study the effect of Bepanthen® Wund- und Heilsalbe on wound healing should be investigated     and compared to Vaseline in vivo following fractional ablative CO2 laser treatment of     photo-damaged skin.   "
14485|NCT03095859|"     This randomized, feasibility trial (n=40) will compare the effects of an intensive, twice     daily inpatient physical rehabilitation program against standard care (once daily) following     double lung transplantation.   "
14486|NCT03095846|"     This study investigates cold-induced brown fat activation in winter swimmers and not-winter     swimmers by skin temperature measures assessed with infra red thermography imaging and skin     temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling     intervention and thermoneutral intervention for comparison of energy expenditure and skin     temperatures at the supraclavicular area.   "
14513|NCT03095495|"     The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC     group and the standard therapy group with rescue HHHFNC to study the efficacy of this     treatment.   "
14894|NCT03090516|"     This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function     in patients with mild-to-moderate elderly, to observe the effects of different intervention     time on cognitive function, for alzheimer's patients in drug rehabilitation treatment     provides an effective solution.   "
14487|NCT03095833|"     Functional Magnetic resonance study on the effect of cognitive context variables on the     perception and valuation of food odorants and flavor. The study is composed of two     experiments; in a first experiment we address the question of how valuation of food odors are     modulated by 3 cognitive conditions (indulgence, healthy, and neutral). Food odors are     delivered using a custom-made olfactometer. Here we hypothesize that cognitive regulation can     modulate the primary sensory processing of food odors. We expect that cortical regions     related with valuation and cognitive regulation such as the ventromedial prefrontal cortex     and the dorsolateral prefrontal cortex operate the modulation of primary olfactory cortex and     amygdala. In a second experiment, we aim to reveal the brain areas involved in integrating     food color cues with odor and taste stimuli. Here we hypothesize that color cues are capable     of biasing flavor attributes of food (flavor intensity), and that this bias occurs at     different cortical areas commonly associate with multisensory integration such as the     orbitofrontal cortex, insula, amygdala and hippocampus.   "
14488|NCT03095820|"     To compare the effectiveness of usual care management (UCM) for geriatric depressive symptoms     in the community vs newly-developed lifestyle modification with contingency management (LMCM)   "
14489|NCT03095807|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     assess the safety and tolerability of single doses of NNC9204-1706 administered     subcutaneously in male subjects being overweight or with obesity.   "
14490|NCT03095794|"     The purpose of this study is to investigate neural mechanism of healthy humans underlying     group decision making and compare it with that of individual decision-making. Using     functional neuroimaging technology combining with computational modeling, we examine how the     human brain process social information to make a decision within a group, which often guides     humans to make a better decision using collective wisdom.   "
14491|NCT03095781|"     This phase Ib trial studies the side effects and best dose of Hsp90 inhibitor XL888 when     given together with pembrolizumab in treating patients with advanced gastrointestinal cancer     that has spread to other places in the body. XL888 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving     XL888 with pembrolizumab may work better in treating patients with gastrointestinal cancer.   "
14492|NCT03095768|"     The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven     track record of engaging patients in healthy living and eating through education, live     cooking demonstrations / hands-on cooking classes, exercise and stress management programs.      As a result of the Community Health Needs Assessment, we are collaborating with Cleveland     Clinic Community Outreach and 12th District Representative, John E. Barnes, Jr., to extend     our expertise to the community of Warrensville Heights, Ohio.   "
14493|NCT03095755|"     The investigators will test whether an intervention called ischemic conditioning can improve     paretic leg motor function in chronic stroke subjects.   "
14494|NCT03095742|"     In comatose patients resuscitated from out of hospital cardiac arrest (OHCA), neurological     injuries remain the leading cause of death. The in-hospital mortality is reported at 30-50%,     and the total mortality, although improved substantially over the last decade, remain to be     significant, in most countries at up to 90%. An adequate blood pressure must be maintained in     the post-cardiac arrest patient and helps to avoid further brain injury. The current trial     addresses strategies for neuroprotection using a design of two different target blood     pressure levels. Normal MAP (approximately 65 mmHg) vs. high MAP (approximately 75 mmHg).     Markers measuring global cerebral ischemia caused by cardiac arrest and consecutive     resuscitation, and reflecting the metabolic changes after successful resuscitation are     urgently needed to enable a more personalized resuscitation and post resuscitation care.      It is technically simple and feasible to place a microdialysis catheter in the jugular bulb     and monitor biochemical variables related to cerebral energy metabolism bedside. The LP ratio     obtained from microdialysis of cerebral venous blood may be a sensitive indicator of     impending cerebral damage and might play a critical role in detecting the early responses of     post resuscitation care. Aim of this study is to investigate the global cerebral metabolic     changes during CA and post-resuscitation care.   "
14584|NCT03094559|"     The purpose of this study is to demonstrate the utility of the FlowMet™ device in the     assessment of perfusion in subjects suspected of or being treated for critical limb ischemia,     in comparison to other gold standard technologies, such as ankle brachial pulse index (ABI),     skin perfusion pressure (SPP), toe brachial pulse index (TBI), transcutaneous oxygen tension     (TcP02), and angiography currently in use in the clinic.   "
14501|NCT03095651|"     This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in     participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This     is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants     will be given daily fixed doses of MK-5160 in three predefined, increasing doses in each     panel, or glargine (active comparator). The primary hypothesis of the trial is that at a dose     with sufficient safety, the mean steady-state maximum level of glucose infusion rate (GIRmax)     after MK-5160 administration in both T1DM and T2DM participants is between 1.5 and 4.5     mg/kg/min.   "
14502|NCT03095638|"     The aim of this cross-over study is to compare the relative bioavailability and     pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of     dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be     carried out in 2 parts. Part 1 of the study will be open-label, 2 period designs with a wash     out period of at least 7 days between the dosing periods. Subjects will be randomized to     receive either single dose of five 10 mg DTG tablets or one 50 mg DTG tablet in a crossover     manner in the fasting state. Part 2 of the study will be a 3 period crossover design with a     wash out period of at least 7 days between the dosing periods. Subjects will be randomized to     receive either single dose of five 5 mg DTG tablets (administered as dispersed with water or     directly to mouth) or one 25 mg DTG tablet in a crossover manner in the fasting state.     Subjects will have a follow-up visit 7-10 days post last dose of study treatment.     Approximately 14 healthy subjects will participate in Part 1 and approximately 24 healthy     subjects will participate in Part 2 of the study. The total duration of Part 1 will be     approximately 7 to 8 weeks and that of part 2 will be approximately 8 to 9 weeks.      TIVICAY® is a trademark of the GlaxoSmithKline group of companies.   "
14503|NCT03095625|"     Coagulation dysfunction is frequent in septic patients and it is associated with an increase     risk of mortality. During sepsis platelets number usually decreases and their function is     reduced and this mechanism is sustained by an inflammatory induced coagulopathy. Some recent     studies evaluated the possibility to use viscoelastic whole blood tests of the haemostasis,     such as thromboelastography (TEG), which analyze all blood components and their interactions     during clot formation and dissolution and might be useful for assessing bleeding risk in     septic patients. Maximun amplitude (MA) is one of the variables obtained from TEG analysis     and it expresses the strength of the clot and the efficacy of platelet function. A low level     of MA describes a lower strength of the clot determined by a lower number or a reduced     function of platelet.      The aim of the present study is to evaluate whether a lower level of MA and a pattern of     hypocoagulability might be associated with an increased risk of bleeding and need of     transfusion in patients with sepsis.      We want to conduct a prospective multicenter observational study, enrolling 100 consecutive     adults patients with sepsis. We will exclude patients under 18 years old of age, chronic use     of oral anticoagulant and anti platelet treatment, hematologic malignancy, congenital     bleeding disorders, oral contraceptives, lack of consent.      Primary end point To evaluate whether a lower level of MA might be associated with an     increased risk of bleeding.      Secondary end points: to evaluate whether a different level of MA correlates with the     biomarker of the severity of sepsis such as presepsin, with the biomarker of the severity of     infection and whether a pattern of hypocoagulability might be associated with a risk of     mortality.      All enrolled patients will undergo a blood sample at admission (T0), after 72 hours (T1) and     after 7 days (T2) and all the following parameters will be measured:      Platelet count, APTT, PT, INR, fibrinogen, procalcitonin and presepsin .      Additionally, all viscoelastic parameters (reaction time (R), clot formation speed (K), angle     (alpha) and maximum amplitude (MA)) will be performed at bedside, at T0, T1, T2:      Outcome measurements: Intensive Care Unit Length of Stay and mortality at 28 days and at 90     days.   "
14504|NCT03095612|"     This study is being done to evaluate the safety of the investigational study drug, selinexor     when given with docetaxel to patients who have been previously treated for advanced KRAS     mutant lung cancer.   "
14505|NCT03095599|"     This is a phase 2/3, double-blind, placebo-controlled trial of 888 adults, ages 18 to 60     years old randomized to receive vaccine or placebo in a 5:1 vaccine:placebo randomization.   "
14506|NCT03095586|"     The main objective of this study is to compare the interpretation of health news items     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,     distortion of research results). The news items which reported those studies evaluating the     treatment effect, having highest number of spin in the headline and text and received high     online public attention will be selected. Spin will be deleted and will rewrite the news     items without spin. This sample of news items reporting results of RCTs with and without spin     will be interpreted by English-speaking patients.   "
14507|NCT03095573|"     Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration.     The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam     capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small     bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune     enteropathy in Western countries, and is usually associated with a good response to the     gluten free diet and an excellent prognosis. However, a minority of patients develop     complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and     neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated     T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically     improved thank to the availability of capsule endoscopy exploration. The aim of this study     was to evaluate detection rate and diagnostic concordance of the axial view capsule and     CapsoCam capsules in the same patients.   "
14508|NCT03095560|"     Purpose of the article: aim of the present study was to detect the differences between the     presence or not of body shadows during a virtual reality (VR) training with BTS NIRVANA     (BTsN). Materials and methods: In this pilot study, we enrolled 20 post-stroke rehabilitation     inpatients, who underwent a neurocognitive-rehabilitative training consisting of 24 sessions     (three times a week for 8 weeks) of BTsN. All the patients were randomized into two groups:     Semi-immersive virtual training with (S-IVTSgroup) or without (S-IVTgroup) body shadows.      Each participant was evaluated before (T0), and immediately (T1) after the end of the     training by a skilled neuropsychologist through the administration of a complete battery, and     by a skilled neurologist to assess motor functions.   "
14509|NCT03095547|"     Study of interactions between F901318 and multiple doses of posaconazole and pantoprazole and     single doses of cyclosporine A and tacrolimus in healthy subjects. Pharmacokinetic profiles,     safety and tolerability will be assessed.   "
14510|NCT03095534|"     The study evaluates the feasibility of a staff-lead workout program, 3-Step Workout for Life,     in a local senior living community. Eligible participants will complete assessments before     and after the workout program.   "
14511|NCT03095521|"     The purpose of this study is to evaluate no less therapeutic efficacy and safety of the     Angal, lozenges [Menthol], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA,     lozenges, 0,2 mg + 2 mg + 50 mg (LLC Valeant, Russia) in treatment of patients with     uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a     sore throat.   "
14514|NCT03095482|"     This double-blind randomized controlled clinical trial aims to test whether transcranial     direct current stimulation (tDCS) can be used to modulate fear extinction learning during     exposure therapy for pathological fear, including fear of spiders, snakes, tightly enclosed     spaces, or germs / contamination. Participation takes place over three laboratory visits,     including (1) a pre-treatment visit, (2) a treatment and post-treatment visit, and (3) a 1     month follow-up visit. During treatment, participants will receive either 20 minutes of     active or sham tDCS, followed by 30 minutes of in vivo exposure therapy.   "
14515|NCT03095469|"     Coronary heart disease has a high incidence and high death rate. Percutaneous coronary     intervention (PCI) is an important method for the treatment of coronary heart disease (CHD).     However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a     myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has     sedative and analgesic effects. Dex currently has been widely used in perioperative     management of various surgical.This study intends to verify the effect of heart protection of     Dex in perioperative.   "
14516|NCT03095456|"     This study is a randomized, double-blind, double-dummy, parallel group study to compare once     daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung     function in subjects with COPD and a Low Peak Inspiratory Flow Rate.   "
14517|NCT03095443|"     DDM is a study designed to Test the efficacy of personalized music therapy in reducing     delirium incidence and severity among patients admitted to the Intensive Care Unit.   "
14518|NCT03095430|"     The critically ill polytrauma patient is one of the most complex cases with regard to the     optimization of the intensive care, anesthesia, as well as postoperative management. One of     the most important steps in the complex management of such patients is the modulation of     anesthesia and the volemic resuscitation, especially in the first hours post-trauma, and in     the operating room admission. We start with the assumptions that the optimization of     anesthesia should depend on each patient, being conducted in an individual manner. We also     believe that by individualizing the anesthesia by monitoring the entropy and SPI it is     possible to obtain an appropriate management regarding resuscitation and volume replacement.     Furthermore it assumes that an adequate anesthesia, and resuscitation singled volume     replacement can reduce morbidity and mortality rates as well as the period of stay in the ICU     and recovery time.   "
14519|NCT03095417|"     Primary Specific Aim: Determine the effect of the combined physical exercise and cognitive     training on the cognitive function of ICU survivors aged 65 and older. Hypothesis: In     comparison to older ICU survivors randomized to attention control or either intervention     alone, those randomized to 12 weeks of combined physical exercise and cognitive training will     have higher total index cognitive scores as assessed by the Repeatable Battery for the     Assessment of Neuropsychological Status (RBANS) at 3 and 6 months post randomization.      Secondary Specific Aim 1: Determine the effect of the combined physical exercise and     cognitive training on physical performance, anxiety and depressive symptoms, and quality of     life of ICU survivors aged 65 and older. Hypotheses: In comparison to older ICU survivors     randomized to attention control or either intervention alone, those randomized to 12 weeks of     combined physical exercise and cognitive training will have higher physical performance as     measured by short physical performance battery (SPPB) and two-minute step test, lower mood     and anxiety symptoms as measured by Patient Health Questionnaire (PHQ-9) and Generalized     Anxiety Disorder (GAD-7) scale, and higher quality of life as measured by the Medical     Outcomes Study 36-item short form (SF-36) at 3 and 6-months post randomization.      Secondary Specific Aim 2: To examine the mechanisms of action of combined training.     Hypothesis: At the completion of treatment, the combined intervention group will show reduced     serum levels of CRP, IL-1, IL-6, IL-8, TNF-α, S-100β, and GFAP and increased levels of BDNF,     VEGF, and IGF-1 compared to the attention control, or either intervention alone groups.   "
14520|NCT03095404|"     Currently, there are no studies that address the optimum dosage of lidocaine for surgical     procedures. Lidocaine is a local anesthetic that is injected to induce anesthesia. Improper     or inefficient pain treatment can lead to longer hospital stay, and adverse side effects such     as nausea and vomiting. Opioids are the primary drug to treat moderate to severe pain, but     are also responsible for nausea and other side effects. Lidocaine has shown to have opioid     sparing effects; meaning less opioid use is necessary for pain relief. In this study, we will     conduct a clinical trial to assess the difference between different lidocaine dosage     schedules to determine the optimum dosage that brings maximum pain relief while minimizing     adverse side effects and patient stay. A large benefit in using lidocaine is its documented     opioid sparing which allows for minimal drug treatment.   "
14521|NCT03095391|"     This is a Phase 2b, prospective, open-label study designed to evaluate the safety,     tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with     varying degrees of renal impairment.   "
14522|NCT03095378|"     The aim of this study was to evaluate the effect of two root-conditioning agents used in     conjunction with subepithelial connective graft technique on root coverage outcomes. One is     citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.   "
14523|NCT03095365|"     to compare the effects on pain, disability and psychological factors of the combination of     MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control     electrotherapy usual care in patients with chronic neck pain.   "
14530|NCT03095274|"     Well-differentiated gastroenteropancreatic and lung neuroendocrine tumors are generally     malignancies with a prolonged natural history. However, clinical behavior is heterogeneous     and when tumor progression is observed, treatment options are limited. The most used therapy     for neuroendocrine tumors management are somatostatin analogs. However, even the use in lung     carcinoids is quite usual, no antitumoral activity has been demonstrated. Tremelimumab and     Durvalumab combination could be more efficient drugs to improve immune system activation and     could obtain a significantly higher clinical benefit in these patients. Tremelimumab and     Durvalumab would be the first immune combination agents showing efficacy in neuroendocrine     neoplasms of different origins.   "
14532|NCT03095248|"     In this research study the researchers want to learn more about the effects (both good and     bad) the study drug selumetinib has on participants with neurofibromatosis type II (NF2)     related tumor.      The researchers are asking patients with NF2 related tumors to be in the study, because their     hearing has decreased and/or their NF2 related tumor has started to grow.      The goals of this study are:        -  Determine if selumetinib will stop NF2 related tumors from growing        -  Measure the changes in hearing after receiving selumetinib for 6 months.        -  Determine if selumetinib improves how participants feel (physically and emotionally) and          how participants can perform daily activities.        -  Examine tumor tissue, if available, in a laboratory to see if NF2 related tumors have          targets of selumetinib.   "
14585|NCT03094546|"     The overall objective of this study is to examine the effect of polyamine supplementation on     cognitive performance and further characterization of individuals with subjective cognitive     decline.   "
14524|NCT03095352|"     This is a phase II multicenter study including breast cancer patients with chest wall disease     that is hormone resistant (ER positive/PR positive/HER2 negative breast cancer with     progressive disease on 2 prior lines of hormonal therapy) or triple negative (ER negative/PR     negative/HER2 negative, TNBC). Eighty-four patients will be enrolled at Translational Breast     Cancer Research Consortium (TBCRC) sites and will be randomized 2:1 to receive treatment with     pembrolizumab and carboplatin (n=56, Arm A) or carboplatin alone (n=28, Arm B) until     documented disease progression. Patients randomized to Arm B may cross-over following     progression to pembrolizumab alone (Arm Bx). Patients may have received any number of prior     lines of chemotherapy. Patients in Arm A will be treated with pembrolizumab 200 mg IV and     carboplatin AUC 5 IV every 3 weeks for at least 6 cycles followed by maintenance     pembrolizumab 200 mg IV every 3 weeks if stable or responding disease. Patients in Arm B will     be treated with carboplatin AUC 5 IV every 3 weeks until progression, whereupon they may     cross-over to pembrolizumab 200 mg IV every 3 weeks alone (Arm Bx). An interim analysis for     futility will be performed after 18 patients are enrolled into Arm B to allow early stopping     of that trial arm for lack of efficacy. The primary endpoint is to compare disease control     rates at 18 weeks of treatment. Secondary endpoints include progression free survival,     toxicity, and overall response rate.   "
14525|NCT03095339|"     This is a pre-post randomized community-based controlled trial aimed at estimating the     effectiveness of an educational package developed using PRECEDE PROCEED to reduce the     cumulative incidence of Taenia solium cysticercosis in three Provinces of Burkina Faso. The     study design included an 18-months baseline study to measure baseline cumulative incidence of     cysticercosis followed by an 18-month post randomization study to measure the effectiveness     of the intervention. Sixty villages of three Provinces of Burkina Faso were included. The     primary outcome was the change in the baseline to post randomization cumulative incidence in     the intervention group compared to the control group.   "
14526|NCT03095326|"     Splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine     (Prevenar 13®) at the start of the trial, following which they were randomly assigned to 2     groups (zinc and placebo group). After 8 weeks, the subjects received PPV pneumococcal     vaccine (Pneumovax®). Zinc syrup was provided to the zinc group at a dose of 1.5 mg/kg/day     (maximum of 50 mg/day). Pneumococcal IgG examinations were conducted at the start of the     trial and after 12 weeks.   "
14527|NCT03095313|"     This is a pilot study in which we will aim to demonstrate successful execution of the imaging     protocol and to make observations regarding the calcification activity as measured by 18F-NaF     PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of     aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters.      Additionally, the data will serve as preliminary data to plan a larger study to investigate     study objectives.   "
14528|NCT03095300|"     Background High-flow nasal cannula (NHF) are a promising tool for administering oxygen to     critically ill patients with high respiratory demand.      Prone positioning (PP) is a simple and cost-effective strategy that since 1980s has been used     in mechanically ventilated patients with acute respiratory failure to treat oxygenation     impairment.      A large randomized study detected a relevant survival benefit by prone positioning in     patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing     invasive mechanical ventilation and managed with the ARDS network PEEP-FiO2 table strategy.      Theoretically, PP may benefit spontaneous breathing patients too, but data concerning its     application in such context are limited to small case series and a retrospective study.      The investigators designed a pilot feasibility study to assess the safety and efficacy of     prone positioning in acute hypoxemic respiratory failure patients noninvasively treated with     NHF.      Methods Patients: 15 adult hypoxemic (PaO2/FiO2<300 mmHg) non-hypercapnic patients with acute     respiratory failure.      Protocol Eligible patients will undergo NHF during a 1-hour monitoring window in the supine     semi recumbent position (baseline, BL).      After 1 hour of NHF in the supine semi recumbent position, an ABG and a monitoring visit will     be performed to confirm the presence of the inclusion and the absence of exclusion criteria.      Afterwards, each enrolled patient will be placed in the prone position for 2 hours.      After a 2-hour PP period, the patient will be rotated and will undergo 2 hours of NHF in the     semi recumbent supine position (Supine step).      Measurements Patient's demographics will be collected at study entry.      At the end of the monitoring period, and then on a hourly basis the following data will be     collected:        -  Respiratory rate, SpO2, pH, PaCO2, PaO2, SaO2, PaO2/FiO2;        -  Heart Rate, arterial blood pressure;        -  Dyspnoea, as defined by the Borg dyspnoea scale;        -  Discomfort, as defined by a visual analogic scale (VAS) adapted to rate the procedural          pain of ICU patients;        -  End expiratory lung impedance (EELI), tidal volume distribution, global and regional          lung dynamic strain (Change in lung impedence due to tidal volume/ELLI).      The number of adverse events will be also recorded for each study step.   "
14529|NCT03095287|"     This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label     study of approximately 25 male subjects with congenital hemophilia A who will receive their     first (primary) immune tolerance induction (ITI) treatment with Alphanate.      The study consists of 2 phases:        -  An ITI Treatment Phase in which all eligible subjects will receive ITI treatment with          Alphanate for a period of up to 33 months. Upon confirmation of complete immune          tolerization, subjects will then enter a 12-month Prophylactic Phase. If, after 33          months of ITI, a subject has achieved partial immune tolerance, the subject will enter a          12-month Prophylactic Phase.        -  A 12-month Prophylactic Phase for all subjects who meet the criteria for complete or          partial success to continue on a prophylactic dosing regimen of Alphanate.   "
14531|NCT03095261|"     The objective of this study is to examine whether a financial incentive program increases     minutes of moderate-to-vigorous physical activity (MVPA) per week among cardiac     rehabilitation (CR) graduates.   "
14654|NCT03093649|"     Although patient-reported adverse events have been promoted as an essential element in     clinical trials and daily managements, their efficacy remained unknown. The purpose of this     trial was to determine the effect of the patient-reported adverse events during the treatment     on the improvements on quality of life.   "
14540|NCT03095144|"     Background: The purpose of this retrospective study is to evaluate surgical outcomes of     pyloromyotomy in infants performed under spinal anesthesia compares to general anesthesia.      Methods: After receiving the approval of the hospital ethics committee, retrieving, reviewing     files and collecting data. Primary outcomes: total operating room time, duration of surgery,     pain management and postoperative apnea episodes, time of regaining full enteral feeding.     Secondary outcome measures: include cardio-respiratory changes and events, and substantial     vomiting postoperatively.   "
14533|NCT03095235|"     Corneal ectasia is characterized by irregularity and thinning of the cornea, causing the     cornea to bulge forward and cause distorted vision and impaired visual acuity. Corneal     ectasia is a complication after refractive (LASIK) surgery. It is also the primary problem in     keratoconus, a gradually progressive inherited condition that typically is manifested in     young adulthood, more commonly in women. Treatment approaches to stabilize the cornea's shape     include rigid contact lenses, surgical implantation of stiff plastic intrastromal corneal     ring segments, a collagen cross-linking procedure and, in severe cases, cornea     transplantation. The collagen cross-linking procedure involves topical application of a     concentrated riboflavin (vitamin B2) solution after the corneal epithelium is scraped,     followed by ultraviolet (UV) light exposure. UV light stimulates riboflavin to form new bonds     (cross links) between the cornea's connective tissue, giving the cornea additional strength     to maintain its shape and prevent the need for transplantation. The cost of one treatment     using this system is $2,500 to $3,500. A small prospective study including 7 patients with     keratoconus was started on a trial of oral riboflavin and 15 minutes of natural sunlight     exposure daily. These patients reported no adverse effects and preliminary results showed     corneal stabilization and/or corneal flattening in all 7 patients It is hypothesized that     dietary riboflavin and natural sunlight is as effective in corneal crosslinking as the     currently FDA approved Avedro therapy. If the clinical study confirms the investigators'     early observations of the benefits of this approach, coupled with animal studies that     document corneal cross-linking, the investigators will have data to pursue funding for larger     clinical and animal studies. This has the potential to save millions of dollars in health     care costs and ease the burden of treatment in patients who require therapy to induce corneal     cross-linking to stabilize the cornea's shape.   "
14534|NCT03095222|"     The purpose of this study is to identify the optimal dosing strategy for low-dose ketamine     infusions in adult acute burn injury patients when used with usual pain medications.   "
14535|NCT03095209|"     Patients on this observation study must have planned treatment regimen with concurrent CRT     followed by planned surgery, which is considered as standard of care for their disease. The     total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60     Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen     will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned     to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing     CRT with surgical aspects determined by the treating surgical oncologist.      Patients on this observation study will donate their blood samples within 4 weeks before     initiating CRT, within 1 week before completing CRT, 1 month after CRT, and 1 month after     surgery (or 3 months after CRT if surgery is not done for any reason). They are also     requested to fill out questionnaires (EORTC QLQ-30, EORTC QLQ-OES18, and Pain Scale as     attached) prior to CRT, weekly during CRT, 1 month after CRT, 1 month after surgery (or 3     months after CRT if surgery is not done for any reason), and 6 months after CRT. Any patients     with incomplete treatment will have samples collected up to the point where they discontinue.     The specimen collection, handling and processing will be done by Protocol Support Lab (PSL)     at Fox Chase Cancer Center under the directions of the Director, R. Katherine Alpaugh, PhD,     following the procedures outlined in PSL lab manual. The patients in this observation study     will be asked to donate a tissue specimen after the definitive surgery for investigation.   "
14536|NCT03095196|"     Background: Type 2 Diabetes Mellitus (T2DM) is a multi factorial disease, affecting clinical     outcomes in failing heart (HF) patients treated by Cardiac Resynchronization Therapy with a     defibrillator (CRT-d).      Methods: One hundred and ninety five T2DM patients will receive a CRT-d treatment. Randomly     the study population will receive a CRT-d via multipolar left ventricle (LV) lead pacing (n     99 as Multipolar group), v/s a CRT-d via bipolar LV pacing (n 96, as Bipolar group). These     patients will be followed by clinical, and instrumental assessment, and telemetric device     control at follow up. Study design will be to evaluate, in failing heart T2DM patients,     cardiac deaths, all cause deaths, arrhythmic events, CRT-d responders rate, hospitalizations     for HF worsening, phrenic nerve stimulation (PNS), and LV catheter dislodgment events (and     re-intervention for LV catheter re-positioning), comparing multipolar CRT-d v/s bipolar CRT-d     group of patients at follow up.   "
14537|NCT03095183|"     Evaluation of the oropharynx is a standard component of a general medical exam for all     pediatric patients, but is an essential exam in the undifferentiated ill child. Pediatric     patients are unable to verbalize where they hurt, and a comprehensive evaluation is needed to     identify the source of fever and illness. Frequently, illnesses will present atypically as     well, and a patient complaining of abdominal pain may ultimately be diagnosed with     streptococcus pharyngitis. If the examiner does not evaluate the posterior oropharynx, the     throat as a cause of abdominal pain is easily overlooked. Additionally, young children are     prone to infections with pox viruses causing herpangina, hand foot and mouth disease, oral     thrush. Despite the importance of the posterior oropharynx exam, it can be a source of stress     and anxiety for both the clinician and pediatric patient when a tongue depressor is used to     evaluate the posterior oropharynx. However, there are no studies to date that have looked at     decreasing the difficulty or at decreasing the perceived discomfort associated with the     poster oropharynx exam in the pediatric patient when a tongue depressor is utilized. Despite     this paucity of research, there are multiple different flavored and candied tongue depressors     available for this purpose which may or may not aid in obtaining posterior oropharynx exam     and decrease the discomfort experienced by the patients.   "
14538|NCT03095170|"     Behavioral interventions currently provide the most useful approach to addressing the     behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's     or other diseases. This randomized, multisite, 3-arm study will investigate the impact of     computerized brain fitness vs yoga vs an active control group (wellness education) on changes     in cognitive function, daily functioning and quality of life in persons with Mild Cognitive     Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity     during the pre- and post-intervention periods will be measured and compared between the three     different treatment groups. These neuroimaging measures of plasticity will be investigated in     their relationship to the cognitive outcomes within each group.   "
15220|NCT03086239|"     This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study     to assess the safety and tolerability as well as explore the pharmacokinetics,     pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants     with advanced small cell lung cancer (SCLC).   "
14539|NCT03095157|"     The aim of the study is to investigate whether pre-operative dysregulated systemic lipid     mediator pathways are associated with increased risk for the development of persistent post     surgical pain. In addition we will investigate whether treatment with an over the counter     dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine     oil prevents the development of chronic pain after surgery.   "
14552|NCT03094975|"     Firstly, this study aims at clarifying the current situation of Emergency treatment of     aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the influencing factors     contributing to transport delay, so as to improve the efficiency of emergency treatment;     Secondly, comparison and analysis of different surgical treatment of aneurysmal SAH would be     undertook, so as to improve the diagnosis and treatment of aneurysmal SAH.   "
14541|NCT03095131|"     Question: Is 12-lead electrocardiography (ECG) the most accurate and convenient diagnostic     method for atrial fibrillation (AF)? Findings: The Heart Spectrum Blood Pressure Monitor can     be used at home, and is capable of determining the occurrence of AF. Three measurement     methods were used in this study. The sensitivity, specificity, PPV, and NPV of the methods     used are between 90% and 100%, and the Heart Spectrum Blood Pressure Monitor can be     effectively applied to AF detection.      Meaning: The Heart Spectrum Blood Pressure Monitor can be used at home and can replace the     need for an in-office ECG, thereby accomplishing meaningful telecare.   "
14542|NCT03095118|"     This study is being done to see if daratumumab is safe and effective in the treatment of     proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3     glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease     in the kidney due to the production of abnormal proteins. There are no known standard     effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy.     These diseases are caused by abnormal production of proteins (monoclonals) by abnormal     clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma     a disease which also caused by over production of monoclonal proteins from abnormal clones.     Everyone in this study will receive daratumumab.   "
14543|NCT03095105|"     the purpose of the study was to the compare pharmacokinetic profile of BIA 6-512 in healthy     elderly subjects versus healthy young subjects after single and repeated oral administration     of 200 mg BIA 6-512.   "
14544|NCT03095092|"     The purpose of the study was to investigate the effect of food on the pharmacokinetics of a     single 400 mg dose of BIA 6-512 (trans-resveratrol) in healthy volunteers   "
14545|NCT03095079|"     The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with     cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the     response rate and survival results are very limited.This trial aim to add a safe and     effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy     which may further extend the PFS and OS with a tolerated toxicity.   "
14546|NCT03095066|"     This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the     treatment of neurobehavioral disinhibition including aggression, agitation, and irritability     in participants with traumatic brain injury (TBI).   "
14547|NCT03095053|"     Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF     cycles. Since the inception of IVF, non-invasive morphology based scoring has mostly been     used in the selection of embryos for transfer, resulting in relative low embryo implantation     rates. Our understanding of the optimal conditions required for in vitro embryo culture in     IVF has advanced significantly over the past two decades. The implementation of improved in     vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an     increase in the number of good quality embryos and consequently in the number of blastocysts     developing. While blastocyst transfers have seemingly improved the reproductive outcomes of     IVF, the use of improved preimplantation genetic screening (PGS) technologies have revealed     embryo implantation still to be sub-optimal. The main objective of this randomized controlled     trial will be to investigate the superiority of comprehensive chromosome screening (CCS)     euploid blastocyst transfer compared to morphology scored blastocyst transfer, in FET.      Methods This trial will be performed as a single-centre randomized controlled trial (RCT) in     a segmented-IVF program, with intracyoplasmic sperm injection (ICSI), blastocyst freeze-all     and artificial frozen embryo transfer (art-FET). Normo-ovulatory infertile patients, with     maternal age ≤35 years and at least two blastocysts with a morphology grade of 2BB     cryopresreved, will be randomized by computer generated randomized allocation to one CCS or     the morphology group. All transfers will be single embryo tranfers (SET) in art-FET, with     only the first transfers following the ICSI blastocysts freeze-all included.      Consent and Ethics Akdeniz University Medical Faculty Clinical Research Ethics Committee has     approved the trial (reference number: 2015/399), with anonymized results to be released in     ClinicalTrials.gov. All patients will provide informed consent, which included an agreement     for the use of anonymised data for research.   "
14548|NCT03095040|"     This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety     of CM082 in combination with everolimus in Chinese patients with advanced renal cell     carcinoma. The primary endpoint is progression-free survival.   "
14549|NCT03095014|"     Cesarean Myomectomy, safety and effect on uterine cavity.   "
14550|NCT03095001|"     Background: Malignant peritoneal adhesion is a common complication and prognostic factor of     ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in     advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the     recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and     mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the     abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede     treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis.      Objective: This study aims to treat malignant peritoneal adhesion with the combination of     antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal     antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the     expression of VEGF-A in peritoneal cavity during the treatment.   "
14567|NCT03094780|"     This study will use video technology in conjunction with in-person participation. This is a     pilot project, where all enrolled participants will receive the multidisciplinary     intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend     an in-person group session, and participants (patients and caregivers) from Mayo Clinic     Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use     of video conferencing. The goals are to examine feasibility (percent of eligible patients and     caregivers who enroll), attrition, and adherence (attend at least four of the six sessions),     to determine any differences between the two formats, and to examine potential QOL     differences as a result of the intervention.   "
19631|NCT03028610|"     Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate     pregnancies following the Acessa™ treatment of uterine myomas in women who desire future     childbearing   "
14551|NCT03094988|"     Cognitive and functional impairment are debilitating problems for survivors of major surgery.     Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield     significant benefits. An area in need of study is whether building patients' cognitive and     physical reserve through a prescribed program of cognitive and physical exercise before the     physiological insult (a prehabilitation effort) can improve long-term outcomes.     Prehabilitation efforts before surgery thus far have focused on preemptive physical therapy     to improve post-surgical functional outcomes. No work, however, has been done to attenuate     the cognitive decline commonly seen after surgical illness by exercising the brain before the     surgical insult. Cognitive prehabilitation is a novel therapeutic approach that applies     well-understood techniques derived from brain plasticity research. Our approach is bolstered     by data that demonstrate that cognitive training programs are effective and have a very high     likelihood of fostering improvement in patient outcomes across a range of populations. It is     not yet known if these programs can improve cognitive reserve, allowing patients' minds to     better manage the acute stress of surgery and hospitalization. The primary aim of this pilot     study is to evaluate the feasibility of cognitive and physical prehabilitation training in     adult patients undergoing major non-cardiac surgery who are at risk for postoperative     cognitive and functional decline. The secondary aim is to study the effects of cognitive and     physical prehabilitation training on cognitive abilities, functional status, and quality of     life after surgery.   "
14904|NCT03090386|"     This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced     following brain tumor treatment. Cognitive surveys will be administered after treatment of     primary brain tumor cancer.   "
14553|NCT03094962|"     The proximal interphalangeal (PIP) joint is the second joint in the finger from the finger     tip. The outcome following replacement surgery of this joint is considered unsatisfactory. In     order to improve these outcomes, it would be helpful to understand the geometry of the joint,     how it moves and the forces that are involved. This can be achieved using computer models     that model the bones and the soft tissues - musculoskeletal models. In order to make these     models as representative as possible, they should be generated using anatomical data.      Data will initially be extracted from patients' existing magnetic resonance imaging (MRI) and     computed tomography (CT) scans. This will enable the computer model to begin being     constructed. In parallel to the model initialisation, anatomical and motion data of the PIP     joint of healthy volunteers will be collected. The necessary data will be collected using CT     and MRI scans, as well as optical motion tracking methods. These data will then be used to     populate the musculoskeletal model.      Once the model is constructed, it will be used to simulate the motion of the joint and look     at the effect of a simulated PIP joint replacement. This information should then provide     insight as to how PIP joint replacements might be improved in future.   "
14554|NCT03094949|"     The therapeutic effectiveness of ultrasound guided cooled-probe microwave ablation and     laparoscopic partial nephrectomy on T1a renal cell carcinoma is compared to find a better     approach for renal tumor.   "
14555|NCT03094936|"     Obesity is a worldwide health and sociopolitical problem. Excessive body-weight currently     affects over 50% of the Brazilian population. It has been well established that obesity is an     independent health risk. Obese individuals are at increased to extremely high risk for many     diseases and for early death relative to those with normal weights and waist circumferences.     The increased disease susceptibility for this subset of patients includes hypertension,     stroke, hyperlipidemia, sleep apnea, Type 2 diabetes, neoplasms, Gastro-Esophageal Reflux     Disease, and musculoskeletal disorders.      Bariatric surgery is the most effective treatment for obesity. As bariatrics grow, the number     of patients suffering from surgical-related complications also grows. One of the most     worrisome long-term complications is weight regain, once the patient may be again affected by     overweight-related comorbidities and face again pre-operative esthetic issues.      This trial focus on testing efficacy and safety of two endoscopic revisional procedures in     patients suffering from weight regain following Roux-en-Y Gastric Bypass: Ablation with Argon     Plasma Coagulation (APC) versus APC plus Endoscopic Full-thickness Suture (with Apollo     Overstitch device). Pouch volume, gastric emptying and gut hormones changes will also be     assessed.   "
14556|NCT03094923|"     This study will evaluate the profilatic effects of inspiratory muscle training (IMT) on     functional capacity, respiratory muscle strength, postoperative pulmonary complications and     days of hospitalization (PPC) in patients submitted to coronary artery bypass graft surgery     (CABG).   "
14557|NCT03094910|"     Patients with Raynaud's disease have an increased tendency of chest pain and migraine, and     studies indicate that the disease might be associated with increased cardiovascular morbidity     and mortality. Furthermore, a certain hyperactivity of the sympathetic nervous system has     been demonstrated in these patients. Hyperactivity of the sympathetic nervous system is known     to cause decreasing heart function, regardless of the underlying disease.      The cardiac autonomic nervous function and thermographic parameters will be assessed in     patients with primary and secondary Raynaud's phenomenon and glaucoma as well as in patients     diagnosed with autonomic dysfunction such as diabetics and patients with Parkinson's disease     in order to compare the function of the cardiac autonomic nervous system and the peripheral     response to cold exposure. Potentially, this will lead to a better understanding of the     cardiac autonomic nervous function in Raynaud's phenomenon. Moreover, it might give rise to a     new perception of the condition and its association to cardiovascular disease.      At the Department of Clinical Physiology, the current method of detecting Raynaud's     phenomenon is time-consuming and unpleasant to the patient due to cooling for several     minutes. Another aim of the PhD study is to implement infrared thermography as a gentler and     possibly more sensitive method to replace the currently applied method.      The project will also include an epidemiological study based on data obtained from the     National Patient Registry, among others. Raynaud's phenomenon will be paired with diagnostic     codes of conditions such as diabetes mellitus, Parkinson's disease, glaucoma, and     cardiovascular disease.   "
14558|NCT03094897|"     The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective     for cancer diagnosis.   "
14902|NCT03090412|"     This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works     compared to standard of care surgery in treating patients with oral cavity cancer.     Photodynamic therapy can destroy or control disease by using a combination of drug, such as     HPPH, and light and may be as effective as surgery in treating patients with oral cavity     cancer.   "
14559|NCT03094884|"     Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery     technique can significantly decrease the rate of severe acute esophagitis in patients     receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or     esophageal cancer while maintaining similar efficacy. For these patients, the rate of severe     acute esophagitis during concurrent CRT is high (approximately 20%) when conventional     external beam radiation is utilized. Severe acute esophagitis can cause many adverse     consequences such as severe discomfort, weight loss, hospitalization, interruption/early     termination of treatment, and worse surgical complications for those who receive surgery     after CRT. PLDR radiation has the potential to maintain the tumor control rates of     conventional radiation while decreasing the toxicity to the surrounding normal tissue 29-35.      We have completed accrual to a phase I PLDR radiation study, in which patient received     palliative re-irradiation with PLDR technique for their metastatic disease in previous     irradiated field. In that phase I study, PLDR demonstrated safety for acute toxicities in the     setting of re-irradiation for a total dose of 50 Gy, with analysis of 60 Gy pending. The     follow up time for that phase I study is limited as most enrolled patients have short overall     survival due to their terminal illness.      This proposed phase I study is, to our knowledge, the first clinical study with combination     of PLDR radiation and concurrent chemotherapy for definitive treatment.   "
14570|NCT03094741|"     The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a     Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study     is meant to be the preparatory work for an intervention study to test the effect of Mobile     Digital Solutions on improving patient outcomes by prompting early interventions for symptom     relief and support of patient and family caregiver quality of life (QOL).   "
14571|NCT03094728|"     The study aimed to assess HLA compatibility, HLA antibodies and cross matching in liver     transplantation recipients and their relation to acute rejection, CMV infection, and     recurrence of HCV.   "
14560|NCT03094871|"     Comorbid depression and multiple medical conditions in older adults are a serious public     health problem. As an important facilitator of health-related activities, families are     already involved in various aspects of self-management of chronic disease in older adults.     Despite the benefits they provide, informal caregiving activities currently are organized     outside the medical system, which potentially creates redundant or misaligned efforts.The     purpose of the mentored research is to examine the feasibility and acceptability of the     FACE-PC, a theory-driven, multi- component, technology-assisted interdisciplinary team-based     care model that systematically involves family in chronic disease management. It aims to     optimize the patient and family's collective ability to self-manage chronic disease.   "
14561|NCT03094858|"     Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group     that receives a smartphone and an activity monitor wristband but does not receive smartphone     intervention prompts, or 2) the intervention group who will receive an activity monitor     wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone     prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit®     wristband activity monitor and an Android smartphone on the same day of the week (i.e.,     Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to     the start of the intervention. Participants will be followed for 26 weeks after the     intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be     accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time,     and time spent in light, moderate, and vigorous activity will be additionally evaluated as     outcomes. Contextual variables and potential treatment mechanisms will be assessed via     traditional questionnaire measurement and daily random EMAs at baseline and all follow-up     visits. Brief smartphone-based daily diary assessments will be completed daily for the     duration of the study.   "
14562|NCT03094845|"     hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The     purpose of this study is to assess the safety and clinical tolerability of subcutaneous     immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic     rhinoconjunctivitis compared to placebo.   "
14563|NCT03094832|"     This is an open label, Phase 1/2 study of oral ARQ 092 administered to patients at least 6     years of age with overgrowth diseases and vascular anomalies with genetic alterations of the     PI3K/AKT pathway.   "
14564|NCT03094819|"     The PROTECT2 pilot study is a single cohort prospective study to gather pilot data and     finalize operational details of the main study.      The PROTECT2 main study is a prospective randomized controlled multi-center three group     clinical trial. The primary endpoint is the percentage of participants in each study group     obtaining a qualified eye examination within 12 months of their enrollment in the study.   "
14565|NCT03094806|"     This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive     Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic     obstructive pulmonary disease (COPD) exacerbation.   "
14566|NCT03094793|"     Cognitive disorders are a major problem in patients with epilepsy. One hypothesis is that the     anomalies EEGs (AIC) may be responsible for short periods of attentional fluctuations causing     a reduction of intellectual efficiency of patients. In this project, we propose to evaluate     the impact of AIC on cognitive performance, specifically on attentional performance (central     parameter of cognitive functioning) through the use of a computerized cognitive test (called     STABILO, detailed below after) to measure, with good temporal sampling, the level of     attentional engagement of patients in relation to their EEG activity.      The originality of this study lies in the synchronization of two examinations usually made     independently (EEG and psychometric testing), respecting a precise temporal coupling. The aim     is to provide clinicians with a tool to assess very quickly attentional fluctuations in     epileptic patients, and to assess the potential impact of AIC on the occurrence of these     changes, with possible therapeutic implications (treatment of AIC and / or specific treatment     of attention deficit disorder).      The main objective of this study is to assess whether the presence of AIC EEG can induce a     weakening of attentional performance.   "
14946|NCT03090048|"     Patients seen with acne lesions not having responded to existing treatments will be offered a     placebo or a topical preparation consisting of Vitamin A USP with or without Azithromycin for     a duration of 4-6 months USP for the objective of resolving the lesions without systemic side     effects and via weekly follow-ups.   "
14568|NCT03094767|"     Cardiovascular autonomic dysfunction reflects the pathophysiology of Diabetes Mellitus in     this patient group favors an increase in morbidity and mortality related to cardiovascular     events, and for this reason has been one of the most studied clinical entities.      Therefore this work aims to analyze the cardiorespiratory parameters and glycated hemoglobin     after the commission of a rehabilitation program in patients with diabetes mellitus type 2.      The collection protocol is to check the heart rate, blood pressure, double product, Borg     scale, variability heart rate and glycated hemoglobin of patients with type 2 diabetes This     project this is an experimental study, the type randomized clinical trial on the hemodynamic     response and glucose levels in patients with DM2 institutionalized in Acre Hospital     Foundation submitted to one rehabilitation program consisting of aerobic and anaerobic     exercises performed for 12 weeks in three weekly meetings, of 60 minutes each.   "
14569|NCT03094754|"     The primary purpose of this study is to investigate the effects of excised surface area/body     surface area ratio and location of excision on the postoperative pain after nevi excision in     children.      The primary purpose of this study is to investigate the effects of excised surface area/body     surface area ratio and location of excision on the emergence excitation after nevi excision     in children.   "
14583|NCT03094572|"     The general objective being to determine the modifications nature induced by upper extremity     kinematic rhythmic task realization on cervical HSCC.      The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured     subjects in addition to existing therapeutics.   "
14572|NCT03094715|"     TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time     window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized,     controlled, post-market study to compare the safety and effectiveness of endovascular     thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke     patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score     (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of     symptom onset). Up to 714 subjects will be randomized. Primary endpoint will be functional     outcome assessed by the modified Rankin scale at 90 days post-stroke (mRS shift analysis).     By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute     stroke population with uncertain benefit of endovascular stroke treatment.   "
14573|NCT03094702|"     The SPRINT study used a blood pressure measurement procedure that differs from earlier     studies in arterial hypertension. SPRINT type readings are lower than regular office     measurements. The extent of the disagreement between SPRINT and office measurements may     differ in distinct patient groups. This difference is not yet known for patients after renal     transplantation. However, it is important to know the difference in order to apply SPRINT     findings to transplant recipients.   "
14574|NCT03094689|"     Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical,     biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners.      Materials and Methods: This is a randomized, blinded trial in which 30 subjects, 10 km street     runners, were randomly divided into three groups: control (gC), immersion (gI) and CWI     (gCWI). The runners will be evaluated for clinical (subjective perception of exertion),     biochemical (serum CK), functional (unipodal triple hop distance and shuttle test time) and     neuromuscular variables by means of isokinetic variables (peak torque, total work and fatigue     index). Volunteers will perform pre-assessment, immediately post-race and post-intervention,     and 24-hour post-intervention. The data will be expressed by mean and standard deviation,     analyzed in the statistical package SPSS 20.0. A significance level of 5% and a 95%     confidence interval will be considered for all measures.   "
14575|NCT03094676|"     Performing physical exercise alters the body's homeostasis, and recuperative techniques seek     to anticipate and potentiate the body's recovery. One of the ways to demonstrate a recovery     of the organism is the resumption of autonomic cardiac modulation analyzed through heart rate     variability (HRV), a method of global assessment of the behavior of the autonomic nervous     system. Among the recovery techniques, massage is the most widely used technique in sports.     Therefore, the objective of the study will be to measure the effects of massage as a     recuperative technique on autonomic cardiac modulation at different moments of application.     It will be a randomized clinical trial where there will be five stages of evaluation. In the     first stage, the behavior of the baseline HRV will be evaluated, in the second stage the     behavior of the HRV in front of the massage, in the third stage the behavior of the HRV in     front of the stress protocol, in the fourth stage the HRV behavior after the stress protocol     and immediately after Execution of the massage and finally in the 5th stage where the HRV     behavior will be evaluated after the stress protocol and the massage application will be     performed at the moment of HRV recovery. The stress protocol will be composed of squats     followed by jumps and wingate test, and massage by slides in the anterior thighs and     posterior trunk. The HRC indexes in the time domain, frequency domain and Poincaré plot, as     well as cardiorespiratory parameters and a questionnaire on individual touch perception will     be analyzed. The descriptive statistical method will be used and comparisons of     cardiorespiratory parameters and HRV indices will be performed using the analysis of variance     technique for repeated measures model in the two factor scheme. The level of significance     will be p <0.05 for all tests.   "
14576|NCT03094663|"     A comparison of two pain control methods - the combination of Adductor Canal Block     (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal     artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)     - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with     ambulation on postoperative day one (24 hours post-block administration).   "
14577|NCT03094650|"     The present study aims at investigating (i) the feasibility in chronic stroke of using a     dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and     embodied visual feedback to deliver functional exercises designed for training of impaired     upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes     in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance     to such a technology. The investigators hypothesize that intensive VR-based rehabilitation     may lead to high rehabilitation doses and functional improvement in chronic stroke.   "
14578|NCT03094637|"     The goal of this clinical research study is to learn if azacitidine in combination with     pembrolizumab can help to control myelodysplastic syndrome (MDS). The safety of this drug     combination will also be studied.   "
14579|NCT03094624|"     The project studies auditory deficits in congenital amusia at the behavioral and     neurophysiological levels.      The auditory processes investigated are pitch discrimination, short-term memory,     sound-induced emotions. To characterize auditory deficits in the amusic population,     neuropsychological assessments are combined with neurophysiological markers     (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging:     MRI).   "
14580|NCT03094611|"     The goal of this clinical research study is to learn if inotuzumab ozogamycin can help to     control the disease in participants with acute lymphocytic leukemia (ALL). The safety of this     treatment will also be studied.   "
14581|NCT03094598|"     The purpose of this study is to investigate the knowledge about randomised clinical trials     and the attitude towards clinical research among Danish outpatients. The INFO Trial was     designed as a randomised, parallel group, observer-blinded trial comparing three types of     written information (a leaflet, a brochure, and a booklet) to each other and to a no     intervention group.   "
14582|NCT03094585|"     The purpose of this study is to examine (a) nurses' knowledge about and attitude towards     clinical research, and (b) the effect of written and oral information on nurses' knowledge     about and attitude towards clinical research.   "
16436|NCT03070340|"     The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance     imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual     disease extent in patients who have completed neoadjuvant therapy (NAT).   "
14586|NCT03094533|"     The purpose of this study was to evaluate the efficacy and safety of sevoflurane-only     Volatile induction and maintenance anesthesia (VIMA) and total intravenous anesthesia (TIVA)     using only propofol in adult patients scheduled for elective lobectomy surgery. We would like     to know if there is a difference in blood glucose levels during surgery and whether the cause     is due to the difference in secretion of insulin and cortisol. In addition, we aim to     contribute to the improvement of the prognosis of the patients by helping the selection of     general anesthesia more effective in maintaining homeostasis in the surgical patients by     general anesthesia and further controlling the blood glucose level.   "
14587|NCT03094520|"     The main objective of the proposed research is to extend our understanding of how gesture and     language interact, focusing on the role of cognitive embodiment in this interaction, and to     explore the neural systems that support links between language and actions systems.   "
14588|NCT03094507|"     The purpose of this study is to look at the levels of three HIV medications: dolutegravir,     darunavir and cobicistat in the blood after drug intake has been stopped, in order to     understand how long these drugs persist in the blood. The study will specifically look at     blood levels of these three drugs after taking them every day for 14 days.      There will be two groups. Participants in Group 1 will take dolutegravir everyday for 14     days, then nothing for 7 days, then dolutegravir and darunavir/cobicistat together for 14     days, nothing for 7 days, and then darunavir/cobicistat alone for 14 days. If participants go     into Group 2 they will begin with darunavir/cobicistat everyday for 14 days, then nothing for     7 days, then dolutegravir and darunavir/cobicistat together for 14 days, nothing for 7 days,     and then dolutegravir alone for 14 days. Drug levels for both groups will be measured on days     14, 35 and 56. If the participants decide to take part, the duration of the study will be up     to 57 days plus a screening visit which will take place up to 28 days prior to the start of     the study, and a follow up visit, which takes place 15 to 22 days after the last dose of     study medication. Eligible participants will be randomized (1:1 ratio) to group 1 or group 2.     Participants and the study doctor will know which study medications the participant is taking     at all times during the study.   "
14589|NCT03094494|"     An observational two-center case-control study exploring the clinical impact of     double-carbapenem use in a population of critically il patients with severe     carbapenem-resistant Klebsiella pneumoniae infection   "
14590|NCT03094481|"     The optimal analgesic peripheral nerve block (or combinations thereof) are undefined for     clavicle fractures, the most frequent fracture in the human population. This goal of this     study is to determine whether interscalene block (ISB), superficial cervical plexus block     (SCPB), or both provide the best analgesia for lateral and midshaft clavicular fractures,     respectively.   "
14591|NCT03094468|"     The aim of this phase III study is to establish the efficacy and safety of P-3058     (terbinafine 10% nail solution) topically administered once weekly in patients with     onychomycosis in comparison to the Vehicle in a double-blind fashion. The overall treatment     period will be of 48 weeks.   "
14592|NCT03094455|"     A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron     system (MNS), has been used with promising results on the Upper Limb (UL) function in some     studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide     evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP     (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is     chosen as primary outcome measure and a sample size of 10 per group is required. The     rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver,     manage, monitor and measure a personalized AOT.   "
14593|NCT03094442|"     The primary aim is to evaluate whether standard administration of Dexamethasone at the time     of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would     result in improved quality of recovery (QoR).   "
14617|NCT03094130|"     The main objective of this study is to compare the interpretation of health news items     reporting results of phase I/II (non-randomized) trials with or without spin (i.e.,     distortion of research results). The news items which reported studies evaluating the     treatment effect on human health, have high number of spin in the headline and text and     received high online public attention will be selected. Spin will be deleted and will rewrite     the news items without spin. This sample of news items reporting results of phase I/II     (non-randomized) trials with and without spin will be interpreted by French-speaking     population.   "
14655|NCT03093636|"     The purpose of this study is to reduce the frequency of hypoglycemia and severe hypoglycemic     events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM).     Hypoglycemia is the number one fear of many individuals and families with someone who has     type 1 diabetes, and this fear often prevents optimal glycemic control. It is expected that     this protocol will yield increased knowledge about using a decision support system to help     control the glucose level.   "
14594|NCT03094429|"     This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2     (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as     treatment for refractory schizophrenia.      Part 1 Objectives: There are two primary objectives for Part 1 of this study:        1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000          mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the          residual symptoms associated with refractory schizophrenia in adults, and; to determine          the optimal dose to be used in Part 2 of this study.        2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part          2 of the study The secondary objective of the Part 1 of this study is to evaluate the          safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day),          in combination with clozapine.      Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the     effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared     to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms     associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of     this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose     determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with     clozapine.   "
14595|NCT03094416|"     This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules     in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating     changes in serum levels of TSH upon switch to Tirosint with respect to baseline.   "
14596|NCT03094403|"     A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study   "
14597|NCT03094390|"     This study aims to test the accuracy of the total thoracic fluid content (TFC) measured by     cardiometry can predict weaning-induced pulmonary edema and subsequently weaning failure.     Area under receiver operating characteristic curve (AUROC) will be determined, sensitivity,     specificity, and best cutoff value will be calculated for TFC in prediction of weaning     failure.   "
14598|NCT03094377|"     Despite the advances in stroke rehabilitation, post-stroke upper extremity impairment is     still a major challenge. Increasing evidence can be found supporting stimulation of the     afferent receptor enhances neuroplasticity in the brain. Studies have suggested multisensory     stimulation could promote motor learning by re-establishing the disrupted sensorimotor loop     due to stroke and enhance neuroplasticity.      The objective of the study was to examine the effect of multisensory stimulation on     upper-extremity motor recovery and self-care function in stroke patients.   "
14599|NCT03094364|"     Randomized waitlist control trial. One group will receive treatment immediately (50%) and the     other group will receive treatment following a three-week delay (50%). Group 1 will be     assessed by physical/occupational therapists and rehabilitation psychologists (blinded to     treatment phase) before and after the virtual gaming treatment. Group 2 will receive two     baseline assessments (baseline followed by three weeks of usual and customary care and then     another baseline before starting the gaming treatment), and again after three weeks of     virtual gaming treatment.   "
14600|NCT03094351|"     This is the first randomized controlled study to compare the robot-assisted     thoraco-laparoscopic esophagectomy (RATLE) to minimally invasive conventional     thoraco-laparoscopic esophagectomy (CTLE). The aim of this trial is to evaluate the safety,     risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes     and long-term oncological outcomes between the two surgical treatments.   "
14601|NCT03094338|"     Education is a process of human development for quality of life. Nurse anesthetist students     in 1-year training program have to face occasional stress perioperatively such as long and     unpredictable working hours, exposure to chemical and radiation hazards, or the occurrence of     unexpected death, particularly when a given patient was previously healthy. This can     sometimes prove frustrating and may lead to unsafe practices. Students with mild to moderate     stress, act as achievement motive, driving them to succeed their goals in learning. However,     anyone with severe stress often fails in his or her study. If learners face tension during     their education and they are not able to solve it instantaneously; the stress becomes a     vicious matter.   "
14602|NCT03094325|"     There is no current way to monitor the depth of surgical septal myectomy during the on-pump     period in the OR. This is because the heart is empty of blood and TEE and epicardial imaging     is impossible. A probe device used during in neurosurgery may make the surgical procedure     more accurate and decrease complications of too little myectomy or too much myectomy. It     may decrease the need for reoperation which is currently a risk of myectomy 1-2%.   "
14603|NCT03094312|"     Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of     numerous drug treatments, one third of patients still have seizures, which are associated     with significant cognitive and social complications and excess mortality. In these patients,     surgical treatment to remove the epileptogenic zone (EZ), the region of the brain responsible     for seizures, is the only approach that can allow control of the disease. However, before     investigating this surgery, investigations have to answer two questions: (i) what is the     location and extension of the EZ and (ii) what functional risks, both motor and cognitive,     would represent the resection of this Cortical region? As it is a functional surgery, it is     in fact inconceivable that the surgery will result in an over-handicap. For these reasons,     all candidates for surgery benefit from a complete assessment including imaging examinations,     a neuropsychological assessment and a long-term video-EEG recording to record seizures.     Nevertheless, in some patients, this assessment does not give us a formal answer. In these     subjects, it is then necessary to carry out a second step, consisting of an invasive     exploration by implantation of intracerebral electrodes during a stereoencephalography     (SEEG). Due to its temporal and spatial resolution, the SEEG allows, besides the precise     determination of the EZ, to carry out a functional mapping of the cortical regions likely to     be included in cortectomy. Conventionally, this mapping is carried out on the basis of the     cortical electrical stimulations applied to the implanted electrodes. If this approach is     very robust for exploring primary functions such as motor skills or language, it cannot be     used to evaluate more complex cognitive tasks such as face recognition or attention Effective     cognitive treatment on a daily basis. This has led to the development in recent years, in     Lyon and Grenoble, of a complementary approach to cerebral stimulation: dynamic spectral     imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a     cognitive task associates with the generation within the cortical regions involved in its     treatment of a particular cortical activity. This activity is characterized by oscillations     of the cortical rhythm in high frequencies (> 30 Hz), called gamma activities. The ISD thus     consists in mapping this gamma activity during various cognitive tasks, thus making it     possible to study more widely the complexity of the cognitive functions. Correlations between     gamma activity and cognitive tasks have so far been exclusively performed in the     non-epileptic cortex explored at the periphery of the EA during SEEG. Nevertheless, the     cortical oscillatory pattern study associated with a specific cognitive task within the EZ     could better anticipate complex cognitive deficits that could be generated by the resection     of a cortical region.      The main objective of this project is to establish the predictive character of the gamma     cortical oscillatory pattern associated with a specific cognitive task on the risk of     occurrence of a cognitive disorder after surgery of epilepsy.   "
14604|NCT03094299|"     This study aims to evaluate the efficacy of ultrasound derived variables in prediction of     success of weaning from mechanical ventilation in critically ill patients with abdominal     sepsis   "
14605|NCT03094286|"     The proposal is a phase II clinical study designed to assess the feasibility of durvalumab     (MEDI4736) in HIV-1-infected individuals with solid tumors. Additionally, to obtain data that     lets understand the possible benefit of this treatment in cancer patients and HIV infection,     exploring if activity of durvalumab (MEDI4736) could be higher in cancer that has been     produced at least in part due to the chronic immunosupression. Simultaneously, it will allow     us to investigate the effect of disrupting this immunoregulatory pathway might have in     reversing cancer pathways and HIV-specific T-cell function during persistent chronic HIV     infection in humans.   "
14606|NCT03094273|"     Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2     mm margin.   "
14618|NCT03094117|"     The main objective of this study is to compare the interpretation of health news items     reporting results of phase I/II (nonrandomized) trials with or without spin (i.e., distortion     of research results). The news items which reported studies evaluating the treatment effect,     having highest number of spin in the headline and text and received high online public     attention will be selected. Spin will be deleted and will rewrite the news items without     spin. This sample of news items reporting results of phase I/II (non-randomized) trials with     and without spin will be interpreted by French-speaking patients.   "
14656|NCT03093623|"     In this proposed project,investigators will estimate the effect of physical activity and     abstain from smoking on the regression of precancerous neoplasia.   "
14607|NCT03094260|"     Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence     three times higher than anorexia. Its pathophysiology remains poorly understood and the     investigators have few therapeutic options. Following a review of the literature, the     investigators hypothesize that luminotherapy could be an innovative treatment of BED by its     favorable effect on triggers of hyperphagic access, circadian disturbances, attention and     impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric     (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy     (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (<500 lux). Treatment will     be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main     objective is to compare the evolution of the number of hyperphagic access before and after     treatment between the two groups. Secondary objectives are to compare characteristics of     hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety,     cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time     Estimation Task, Switching Task), liking / wanted for different food categories and     carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid     abnormalities, 25-OH vitamin D3).   "
14608|NCT03094247|"     An appropriate balance of omega-6 and omega-3 fatty acids is important for support of     neurocognitive development in healthy infants and toddlers. In young children recovering from     severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status.     This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced     fatty acids improve the metabolic and neurocognitive effects in young children in Malawi     recovering from SAM, yielding new knowledge that also has implications for development of     well-nourished children.   "
14609|NCT03094234|"     The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm     expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus     propranolol for the prevention of recurrent esophageal variceal bleeding in patients with     Child A cirrhosis   "
14610|NCT03094221|"     The purpose of this study is to compare two different types of three-dimensional     electroanatomic mapping systems used for the treatment of cardiac arrhythmias. The systems     will be compared in regards to its ability to successfully map and ablate a clinical     arrhythmia, as well as the time invested in this activity.   "
14611|NCT03094208|"     The people with transfemoral amputation who use mechanical prosthesis will be include to this     study. All participants will be assessed and then they will be randomly assigned to two     groups. both groups will receive traditional balance trainnig. Study group will also receive     dual task balance training. Training will take 4 weeks, 3 days a week. After the training     program, both groups will be assessed again and the results will compare.   "
14612|NCT03094195|"     To characterize dose response, and evaluate safety and efficacy of three different doses of     EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN)   "
14632|NCT03093935|"     StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve     stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this     study. After meeting inclusion/exclusion criteria, approximately 50 enrolled patients will     participate in the study through 6 months of follow-up. Various measures will be used to     assess patient response to use of the device.   "
14613|NCT03094182|"     The aim of this study is to evaluate the effect of Intravenous iron isomaltoside on     maintaining hemoglobin concentration in patients undergoing bimaxillary orthognathic surgery.     Fifty-eight patients, aged 19 to 40 years, scheduled for Bimaxillary orthognathic surgery     will be divided into monofer (n=29) and control (n=29) groups. Randomly selected patients of     the ulinastatin group are given intravenous iron isomaltoside. In contrast, patients in the     control group receive an equivalent volume of normal saline as a placebo. The primary     endpoints are postoperative hemoglobin concentration.   "
14614|NCT03094169|"     Approximately 80 male and female patients with documented solid tumor malignancies of     epithelial origin that are locally advanced or metastatic, and either refractory to standard     therapy or for whom no standard therapy is available, will be entered into this Phase 1a/2a,     multicenter, open-label, dose-escalation, cohort study of AVID100.   "
14615|NCT03094156|"     The purpose of the study was to To investigate whether the administration of BIA 6-512 (25     mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when     administered in combination with a single-dose of immediate release levodopa/benserazide     200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a     single-dose of entacapone 200 mg.   "
14616|NCT03094143|"     Aortic stenosis is the most common valvular disease in the Western world. It is caused by     progressive narrowing of the aortic valve leading to increased strain on the heart muscle     which has to work increasingly hard to pump blood through the narrowed valve. Over time the     heart muscle thickens to generate more force, but eventually the heart fails leading to death     if the valve is not replaced with an operation. No medical treatments exist to stop or     reverse the heart valve narrowing. Current clinical guidelines suggest that an operation     should be performed only when symptoms develop or the heart muscle is visibly weak on cardiac     ultrasound scanning. However, symptoms can be difficult to interpret and in many patients the     heart muscle has become irreversibly damaged and the heart fails to recover following     surgery.      Using MRI scans of the heart, the investigators have identified heart scarring which seems to     develop as the heart muscle thickens. Several studies now show that people who have developed     this scarring are more likely to suffer poor outcomes including death. The investigators have     also identified clinical risks that predict the presence of scarring.      The investigators propose a study where patients with severe aortic stenosis but no     indications for valve replacement as per current guidelines are assessed for those clinical     risks. If a participant's risk of having scarring is higher they will undergo a cardiac MRI     scan. If scarring is present participants will be randomised to routine clinical care, or     referral for valve replacement surgery. Participants with no evidence of scarring will be     randomised routine care with study follow or not. The investigators of this study hypothesize     that early surgery will lead to fewer complications and reduced risk of death compared to     standard care.   "
17656|NCT03054402|"     This study is a first in human study that will investigate the safety, tolerability and     pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845     using a placebo controlled, randomized, single center design.   "
14619|NCT03094104|"     The main objective of this study is to compare the interpretation of health news items     reporting results of phase I/II (non-randomized) trials with or without spin (i.e.,     distortion of research results). The news items which reported studies evaluating the     treatment effect, having highest number of spin in the headline and text and received high     online public attention will be selected. Spin will be deleted and will rewrite the news     items without spin. This sample of news items reporting results of phase I/II     (non-randomized) trials with and without spin will be interpreted by English-speaking     population.   "
14620|NCT03094091|"     The main objective of this study is to compare the interpretation of health news items     reporting results of phase I/II (non-randomized) trials with or without spin (i.e.,     distortion of research results). The news items which reported those studies evaluating the     treatment effect, having highest number of spin in the headline and text and received high     online public attention will be selected. Spin will be deleted and will rewrite the news     items without spin. This sample of news items reporting results of phase I/II     (non-randomized) trials with and without spin will be interpreted by English-speaking     patients.   "
14621|NCT03094078|"     The main objective of this study is to compare the interpretation of health news items     reporting results of pre-clinical studies with or without spin (i.e., distortion of research     results). The news items which reported those studies evaluating the treatment effect either     in cell culture studies or animal studies, have high number of spin in the headline and text     and received high online public attention will be selected. Spin will be deleted and will     rewrite the news items without spin. This sample of news items reporting results of     pre-clinical studies with and without spin will be interpreted by English-speaking patients.   "
14622|NCT03094065|"     The main objective of this study is to compare the interpretation of health news items     reporting results of pre-clinical studies with or without spin (i.e., distortion of research     results). The news items which reported those studies evaluating the treatment effect either     in cell culture studies or animal studies, have high number of spin in the headline and text     and received high online public attention will be selected. Spin will be deleted and will     rewrite the news items without spin. This sample of news items reporting results of     pre-clinical studies with and without spin will be interpreted by French-speaking patients.   "
16437|NCT03070327|"     The purpose of this phase I clinical trial is to test the safety of these CAR T cells in     patients with myeloma.   "
14624|NCT03094039|"     This study aims to measure the cardio-respiratory physiological consequences of initiating     resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with     congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown     to offer a higher circulating blood volume, less need for blood transfusion, less need for     inotropes in infants.      Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate     resuscitation including immediate intubation and mechanical ventilation.      With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be     commenced from birth in infants with CDH to benefit from PT.   "
14625|NCT03094026|"     A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve     neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the     cognitive training Lumosity program. In addition, patients' interest in receiving information     regarding genetic risk of cognitive impairment post-HCT will be measured.   "
14626|NCT03094013|"     This study will utilize a mixed methods design featuring quantitative assessment of symptoms     in conjunction with collecting in-depth qualitative data. In this study, perceived stress,     mental health symptoms and behaviors and other variables will be used to test how they will     influence the daily functioning and service utilization for adolescent and adult burn related     injury patients at Mercy Hospital St. Louis Burn Center. The data gathered in the interviews     will explore these constructs in-depth for the participants.   "
14627|NCT03094000|"     Bulimia Nervosa (BN), Binge Eating Disorder (BED) and Night Eating Syndrome (NES) are Binge     Eating Disorders (BE-Dis) in which binge eating episodes are a main symptom. Cognitive     Behavioral Therapy (CBT) is the leading evidence-based treatment for patients suffering from     these disorders. CBT-E is an enhanced trans-diagnostic version of the treatment which     appears to be more effective in a variety of Eating Disorders (EDs). The main goals of this     treatment are reducing dietary restrictions and EDs symptoms as well as food intake     regulation. Self-monitoring (SM) is an important and central tool in this type of treatment     considered crucial for its success. Therefore, during treatment, patients are required to     monitor their eating, the circumstances, and their thoughts and feelings proximate to the     time of eating. Nevertheless, despite the importance of this tool, research has shown that     there are many difficulties challenging the clients' adherence to SM, which might reduce this     treatment's effectiveness and outcome. Additionally, in recent years there has been     cumulative data supporting the use of mindfulness in the treatment of EDs. Mindfulness, as a     western psychological approach, is defined as the unique non-judgmental focus of one's     attention at the present moment. Although SM requires the ability to observe, describe and     identify occurrences, no studies have yet examined the direct effect of mindfulness skills on     SM adherence, and therefore the improvement of treatment outcomes.      The main objective of the present study is to examine the effect of a mindfulness based     intervention on SM adherence during a CBT intervention for BE-Dis, and on the treatment     outcomes as seen in the ED psychopathology and compliance to the nutritional instructions and     food intake composition. Other aims include examining the differences between the     experimental group and the control group, regarding their level of mindfulness and SM     adherence. In addition, mediating and moderating processes between mindfulness and SM     adherence will be examined.   "
14628|NCT03093987|"     Objective      To investigate whether critical care ultrasound oriented shock management in shock patients     in intensive care unit(ICU) can improve outcome.      Methods      Randomized controlled research. Patients were randomly allocated to two groups. In the     critical care ultrasound oriented shock management group (CUSS group), treatment was oriented     by the findings of critical care ultrasound in each shock phase, while in the control group     the decisions about the monitoring and management were made by the clinical team. The goal of     treatments in both groups were decreasing lactate by 20% or more per 2 hours for the     Optimization phase in shock management, and no increase lactate level when removing the fluid     in de-escalation phase. The primary outcome measure were hospital mortality and 28-day     mortality, the secondary outcome measure were the length of ventilation and the length of ICU     stay.   "
14629|NCT03093974|"     The purpose of the trial is to investigate if the use of inhaled colistimethate sodium     administered twice daily for 12 months delays the time to the first pulmonary exacerbation     compared to placebo in subjects with non-cystic fibrosis (CF) bronchiectasis chronically     infected with P. aeruginosa   "
17657|NCT03054389|"     The purpose of this study is to seek to understand the patient's perspective around deciding     to participate in a clinical trial for a Hemophilia therapy   "
14631|NCT03093948|"     Ischemia-reperfusion leads to mitochondrial injury, ion-pump injury, cell membrane damage,     cytotoxic edema, and excessive oxygen free radical formation, and eventually destroys cells.     Cardiac arrest is an example of global ischemia; after spontaneous circulation is restored,     ischemia-reperfusion injury develops in cardiac arrest survivors.      Remote ischemic postconditioning (RIPoC) involves the application of brief, reversible     episodes of ischemia and reperfusion to a vascular bed or tissue, rendering remote tissues     and organs resistant to ischemia-reperfusion injury. Accordingly, RIPoC has been suggested as     adjunctive therapy to mitigate ischemia-reperfusion injury. RIPoC applied by repeated brief     inflation-deflation of a blood pressure cuff protects against myocardial injury, and has been     proven effective in acute myocardial infarction.      This study aims to perform a randomized controlled trial to determine whether RIPoC has a     neuroprotective effect and aids in myocardial recovery in out-of-hospital cardiac arrest     patients after restoration of spontaneous circulation.      Neuron-specific enolase (NSE) at 48 hours after restoration of spontaneous circulation will     be measured as a primary outcome.   "
14633|NCT03093922|"     The purpose of this study is to compare any good and bad effects the study drug atezolizumab     has on the cancer when combined with the standard chemotherapy drugs gemcitabine and     cisplatin (or GC) in two different dosing schedules: chemotherapy (GC) before atezolizumab     vs. GC after atezolizumab.   "
14635|NCT03093896|"     Cognitive impairment is also a major risk factor for development of dementia later in life.     Findings from recent studies suggest that the there are many nutrients contained in foods     that may be important in cognitive function in the elderly. This study evaluates long-term     intervention with almonds and snack mix as a treatment strategy for age-related cognitive     impairment which could possibly prevent the onset of dementia.      The proposed study is designed as a randomized, placebo controlled trial that tests the     effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of shortbread     containing coconut oil on cognitive function in older adults. Secondary outcomes include     plasma biomarkers of oxidative stress and inflammation.   "
14636|NCT03093883|"     The aim of this pharmacokinetic study is to assess the bioequivalence of the generic     Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test     product), to Venofer® Iron Sucrose injection solution 20 mg/mL manufactured by Vifor AG,     Switzerland (reference product). Both formulations contain iron as an active ingredient.     Intravenous iron sucrose is primarily indicated for the treatment of iron deficiency anemia     in adult patients.   "
14637|NCT03093870|"     This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer.     Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive     inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal     growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer     by simultaneous inhibition of these receptors. The purpose of this study is to determine the     safety and efficacy of Varlitinib in combination with capecitabine for the treatment of     Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine   "
14638|NCT03093857|"     Patients with a thoracoabdominal aortic aneurysm in need of an endovascular or open operative     restructuring will be asked to participate in this study. After obtaining written consent a     central venous catheter and a liquor drainage will be routinely placed during surgery. The     catheter and the drainage will stay in the patients for at least 72 hours postoperatively. In     total, nine measurements of the liquor and serum will be performed within a week in order to     determine the following parameters: neuropeptide P, neuropeptide Y, neurofilament triplet     protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen.   "
14639|NCT03093844|"     This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent     System to promote engraftment of haploidentical CD34+ selected cells combined with single     unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.   "
14640|NCT03093831|"     The purpose of this study is to assess the efficacy and safety of Ibrutinib in predominantly     Asian patients with relapsed or refractory marginal zone lymphoma.   "
14641|NCT03093818|"     PREPARE is an international, prospective, multi-center, open, randomized, cross-over     implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel     of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes     include, healthcare expenditure, process indicators for implementation and provider adoption     of pharmacogenomics.   "
14642|NCT03093805|"     The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a     synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin     graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients.     Calcipotriene will be used as the exclusive topical therapy in addition to standard of care     GVHD treatment prescribed for the study subject by the primary physician.   "
14643|NCT03093792|"     The purpose of this study is to look at the effects of a carbohydrate restricted, high     protein, high fat diet on weight loss and health outcomes in women participating in the     Curves Fitness and Weight Loss Program.   "
14657|NCT03093610|"     Previous studies have shown that the removal of the chest tube after lung surgery     significantly improves pain symptoms and lung function. The criteria for chest tube removal     still remain vague in modern thoracic surgery and rely on personal experience instead of     evidence-based criteria. Every hospital has its own traditional standard fluid threshold and     believes in that without adapting and comparing it not even after introduction of newer and     more minimal-invasive operation technique. According to literature the traditional fluid     threshold is varying from 100 to 500 or even more millilitre in 24 hours. Since pleural fluid     resorption is proportional to body weight the investigators believe that a body weight     related approach of chest tube management would improve safety and would allow an earlier     chest tube removal without a higher rate of complication. In this way the investigators     believe in improving pain management and in achieving earlier discharge of the patient.   "
14658|NCT03093597|"     The purpose of the study is to compare the changes in the appearance of dry skin after the     use various moisturizers: white petrolatum ointment, coconut oil, jojoba oil, and almond oil     in patients with dry skin.   "
49470|NCT02638103|"     A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous     administration of TEV-48125 in adult patients with chronic migraine or episodic migraine   "
14644|NCT03093779|"     The purpose of this proposal is to examine the attitudes, knowledge, and skills related to     health information that influence health literacy among Deaf individuals.The study team will     also examine frequently overlooked potential predictors of health literacy, including     cognitive abilities, resilience, and self-efficacy. To achieve the study objectives,     researchers will conduct an explanatory sequential mixed methods design using extensive     quantitative data collection procedures, namely, cross-sectional surveys and measures that     will identify predictors and moderators of health literacy with Deaf and hearing subjects.     These results will inform the subsequent qualitative assessment using elicitation interviews     that will help explain the quantitative results, and elucidate how and why Deaf individuals     access and understand health information. A community advisory board consisting of Deaf     community members will provide oversight to the proposal that will be led by multiple Deaf     investigators, including the PI. The Deaf community, due to communication barriers, relative     social marginalization, and their reliance on visual learning, provides a unique insight into     how health information is distributed and disseminated visually. Findings may be applicable     to other individuals with hearing loss who navigate and cope with life more visually than the     typical hearing person. This will be critical to determine more accurately the effect of     visual learning and existing online health information on health literacy.   "
14645|NCT03093766|"     The goal of this study is to find differences between patients who do and do not develop     ICU-acquired hypernatremia (IAH). Therefore extended sodium and fluid balances will be     performed. Also a couple of other factors that possibly contribute to the development of IAH     and/or could give clues about the mechanisms in the development of IAH will be investigated.   "
14659|NCT03093584|"     Title of the study: Auricular acupuncture (AA) vs. expressive writing for pre-exam anxiety -     a randomised crossover study      Study period: 04 / 2014 - 07 / 2014      Principal Investigator: Prof. Dr. T. Usichenko Department of Anaesthesiology and Intensive     Care Medicine University Medicine of Greifswald      Aim of the study: To investigate the anxiolytic effect of AA vs. expressive writing and vs.     no intervention in students, passing the oral exams in anatomy at the University of     Greifswald      Design: Prospective randomised crossover trial      Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Expressive     writing      Number of volunteers: N = 40      Healthy medical students at the University of Greifswald Participants of the anatomy exams in     spring/summer 2014 Without previous anxiolytic, sedative and analgesic medication No     pregnancy or lactating Informed consent      Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase   "
14646|NCT03093753|"     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak     concentration usually after 30 minutes. When the body senses the increase in blood glucose, a     hormonal process involving insulin takes place to ensure that the glucose is taken up from     the blood for storage and where it is needed for energy in the body. This process then brings     about a decrease in the concentration of glucose until it reaches approximately the starting     concentration. The original concentration of glucose is attained approximately 2 hours after     eating or drinking a carbohydrate food or sugary drink respectively in healthy people.      Different carbohydrates and sugary drinks have different effects on blood glucose response     depending on the amount as well as the type of carbohydrate. Those that give rise to a high     glucose response compared to a reference carbohydrate (usually glucose) are said to be high     glycaemic index (GI) foods and those with a lower glucose response compared to a reference     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.      Research has shown that diets that give rise to a high glucose response are associated with a     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly     comprises of insulin resistance and glucose intolerance which gives an increased risk of type     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)     rather than rapidly (high GI) have health benefits which include reducing the risk of     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can     lower the blood glucose levels.      This research will determine whether the presence of polyphenols in the diet has any lowering     effect on the blood glucose levels and hence the glycaemic index of foods. This will be     determined by asking volunteers to consume pomegranate polyphenols together with different     carbohydrate sources which will define the 6 different interventions. The blood glucose     response of bread will be determined initially as a control reference. All meals will be     consumed in random order.      Analysis will be done by measuring blood glucose response after consumption of the control     reference meal and the test meal containing polyphenols and then determining the incremental     area under the glucose curve.      THE SIX DIFFERENT INTERVENTIONS MAY OR MAY NOT BE COMBINED FOR PURPOSES OF PUBLISHING     RESULTS. EACH INTERVENTION WILL AIM TO HAVE AT LEAST 10 PARTICIPANTS.   "
14647|NCT03093740|"     Open label single center study for the donation of HCV positive kidneys to HCV negative     recipients with interventional treatment to prevent HCV transmission upon transplantation.   "
14648|NCT03093727|"     Very recent studies indicate that a high percentage of HCL, about 50%, have mutations in the     B-RAF oncogene. The development of ultrasensitive methodologies capable of identifying these     mutations in bronchoalveolar lavage will represent a significant advance in the diagnosis and     treatment of these patients. An undetermined percentage of HCL does not present mutations in     B-RAF. Consequently, the deep genetic analysis, through the use of techniques of massive     sequencing, can favor the identification of new alterations that contribute to the     development of the disease.      We hypothesized that patients with HCL may present a different inflammatory state to healthy     subjects or smokers, allowing us to identify new biomarkers.   "
14649|NCT03093714|"     This is a multicenter, randomized, placebo-controlled, dose-escalation study. Enrollment is     planned to occur at approximately 14 global sites. Approximately 24 subjects with CF.   "
14650|NCT03093701|"     Subjects with macular edema will be screened and eligible subject will be enrolled to receive     a single dose of the study drug (TLC399) with either of the three dose strengths by     intravitreal (IVT) route. Each of the three groups will include approximately 22 subjects.     The subjects will be followed for visual acuity, safety, tolerability and retinal thickness     assessment after the single IVT injection of the study drug on Day 1.   "
14651|NCT03093688|"     Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express     homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.     PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our     hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may     decrease the tumor burden and improve overall survival. The purpose of this study is to     assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing     of iNKT cells and PD-1+CD8+T cells.   "
14652|NCT03093675|"     This is a prospective, single-center clinical trial. One hundred and fifty patients affected     by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted     laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System     with the primary objective of assessing the feasibility, efficacy and safety of this     approach.   "
14660|NCT03093571|"     Title of the study: Auricular acupuncture (AA) vs. progressive muscle relaxation for pre-exam     anxiety - a randomised crossover study      Study period: 04 / 2015 - 07 / 2015      Principal Investigator: PD Dr. T. Usichenko Department of Anaesthesiology and Intensive Care,     University Medicine of Greifswald      Aim of the study: To investigate the anxiolytic effect of AA vs. progressive muscle     relaxation and vs. no intervention in students, passing the oral exams in anatomy at the     University of Greifswald      Design: Prospective randomised crossover trial      Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Progressive     muscle relaxation      Number of volunteers: N = 30      Healthy medical students at the University of Greifswald Participants of the oral anatomy     exams in spring/summer 2015 Without previous anxiolytic, sedative and analgesic medication No     pregnancy or lactating Informed consent      Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase   "
14661|NCT03093558|"     AF is associated with significant social and medical costs, including diminished quality of     life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200     adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh     Medical Center (UPMC). The primary objective at present is to obtain extensive feasibility     and pilot data in implementing the Embodied Conversational Agent (ECA) in concert with the     Kardia (KAC) heart rhythm monitor.   "
14662|NCT03093545|"     A single center, prospective cohort, open-label study of rabies post exposure program with     equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in     WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA     responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and     to evaluate adverse events occurring after immunization on days 7, 14 and 28.   "
14663|NCT03093532|"     Effective interventions that can address uncontrolled hypertension, particularly in     underrepresented populations that use the emergency department (ED) for primary care, are     critically needed. Uncontrolled hypertension (HTN) contributes significantly to     cardiovascular morbidity and mortality and is more frequently encountered among patients     presenting to the ED as compared to the primary care setting. EDs serve as the point of entry     into the health care system for many high-risk patient populations, including minority and     low-income patients. Based upon recent studies, the prevalence of uncontrolled/undiagnosed     HTN in patients presenting to the ED is alarmingly high.      Thus emergency department engagement and early risk assessment/stratification is a feasible     innovation to help close health disparity gaps in HTN.      This proposal involves a three-arm randomized controlled trial of 120 patients from the     Emergency Department at University of Illinois Hospital with elevated blood pressure (BP) and     no established primary care provider (PCP). The overarching goal is to improve follow-up     rates and transition to PCP care at a federally qualified community health center (FQHC). The     primary outcome will be blood pressure control. Secondary outcomes will be blood pressure     improvement, treatment adherence, and hypertension knowledge. The central hypothesis of the     proposal is that an ED-based screening, brief intervention, and referral for treatment     program for HTN (SBIRT-HTN) using existing ED resources, coupled with a follow-up visit to an     ED pharmacist-initiated Post-Acute Care Hypertension Transition Clinic (PACHT-c), can be     impactful in a predominately underrepresented hypertensive population.   "
14664|NCT03093519|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's     Disease.   "
14665|NCT03093506|"     A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle     mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on     aerobic metabolism. The main purpose of the present study is to determine if a shorter     treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle     mitochondrial function.      Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if     lower doses of rhEpo have similar effects. A second purpose of the present study is to     determine if micro-dose as well as low-dose rhEpo increases cognitive performance.   "
14667|NCT03093480|"     The primary purpose of this study is to describe the time to tolerization with rFVIIIFc in     participants within a maximum of 12 months of ITI treatment.   "
14676|NCT03093363|"     The impact of a pharmacist's intervention on asthma control has now been well demonstrated,     but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic     patients has been little studied in the literature. The aim of this study is to investigate     the impact of a pharmacist's intervention on FENO in patients seen in clinical practice by a     pneumologist in a secondary university center.   "
14701|NCT03093038|"     The goal of this study is to study the stability of the Delta-TT cup with polyethylene insert     and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means     of RSA to assess whether the differences in stiffness of the cup will have an influence on     incorporation and mechanical stability.      It is hypothesized that there will be more micromotion on the short-term (<2 years) in the     patients with the ceramic insert because of the higher stiffness, however, all components     will be considered stable on the short and long-term.   "
14677|NCT03093350|"     The study is being conducted in patients in which breast cancer has come back after standard     treatment. Volunteers in this research study are treated using special immune system cells     called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental     therapy.      The proteins that investigators are targeting in this study are called tumor-associated     antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not     show, or they show up in low quantities, on normal human cells. In this study, investigators     target five common TAAs. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a     different study, patients have been treated and so far this treatment has shown to be safe.      Investigators now want to try this treatment in patients with breast cancer.      These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not     approved by the Food and Drug Administration.      The purpose of this study is to determine the clinical efficacy of TAA-specific CTLs, to     learn what the side-effects are, and to see whether this therapy might help patients with     breast cancer.   "
18526|NCT03043066|"     To compare the effect of non-surgical periodontal therapy with or without systemic     administration of amoxicillin and metronidazole on the concentration of serum levels of     TRAP-5b in patients with generalized chronic periodontitis.   "
14668|NCT03093467|"     Depression is a highly prevalent disorder in Chile, generating important personal and social     costs. This study aims to evaluate the effectiveness of the internet-based program ASCENSO as     an adjunct intervention for the treatment of depression. ASCENSO provides information to     promote patients' self-care, it monitors reported depression symptoms providing automatized     feedback and provides the possibility of booking a counseling session via chat or by phone.     To evaluate the effectiveness of ASCENSO, an open, evaluator-blind, prospective,     parallel-group (one intervention group and one active control group) randomized controlled     trial will be implemented in one mental health center in Santiago of Chile. The sample will     be composed of adults initiating treatment for depression, and who have internet access.     Participants will be randomly assigned to one of the two study arms. Randomization will be     stratified by the number of patients´ previous episodes (dichotomized into none, 1 or more),     following a permuted block randomization procedure. Patients in the experimental group     (n=100) will receive the usual treatment plus access to the ASCENSO program. The control     group (n=100) will only receive the usual treatment. At recruitment, months 6 and 9,     patients' self-reported depression symptoms and quality of life will be assessed.     Additionally, adherence to treatment in terms of patients' attendance to medical controls and     psychotherapy sessions will be registered for both research groups.   "
14669|NCT03093454|"     This project will evaluate the integration of lavender essential oil in surgical patients     during the perioperative and postoperative phase of care. The study will assess patients'     pain, sleep quality, and mood. The goal is to support that lavender oil will decrease pain     scores and narcotic use, increase sleep quality, and decrease anxiety by improving overall     patient satisfaction and supporting their natural sense of well being. This research project     will help support the use of complementary medicine in a hospital setting. The increased     awareness and use of complementary medicine in a hospital setting will strengthen the patient     centered care model that all hospitals strive to achieve.   "
14670|NCT03093441|"     Recently, it has been demonstrated that multimodal high-intensity interval training (MM-HIIT)     (utilizing resistance-based and functional movements) can produce similar aerobic adaptations     compared to high-intensity interval training (HIIT) using rowing but with greater muscle     performance in females. In addition, HIIT has been shown to be more enjoyable than continuous     training, and this may lead to enhanced self-efficacy and increased physical activity. To the     investigators' knowledge, however, the cardiometabolic effects (blood pressure,     abdominal/visceral fat, blood sugar, blood lipids/fats) of MM-HIIT have not been reported.     The investigators aim to compare MM-HIIT with HIIT using a traditional aerobic fitness     exercise (rowing) for the degree of cardiometabolic, physical performance (strength,     endurance, power), and psychosocial (self-efficacy and enjoyment) adaptations.   "
14671|NCT03093428|"     This research study is studying the safety and tolerability of an investigational combination     of drugs, radium-223 plus pembrolizumab as a possible treatment for castration-resistant     prostate cancer.      The interventions involved in this study are:        -  Radium-223        -  Pembrolizumab   "
14672|NCT03093415|"     hepatitis C virus (HCV) has traditionally been treated in subspecialty health centers given     the complexity of older pegylated interferon containing regimens, formerly the standard of     care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite     their relative simplicity, creating a bottleneck of human resources necessary to fight the     largest infectious epidemic in North America. In addition, stigma and fear over cost has lead     payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of     new infections occur in this population.      This study evaluates the effectiveness of treatment of HCV with elbasvir-grasoprevir in PWIDs     in a real world, community health clinic setting.      There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based     community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory     medication assisted therapy with buprenorphine or extended released injectable naltrexone.     Cohort two maintains active injection drug use with needle exchange and risk reduction     education.      These groups are compared to a 50 patient retrospective cohort of people with substance use     disorders at tertiary care hepatology-based treatment program.      All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks.      The investigators hypothesize there is no difference in sustained viremic response at 12 or     48 weeks post-completion of treatment (SVR 12, 48) when treating patients in a community     health clinic setting as compared to the standard-of-care subspecialty setting.   "
14673|NCT03093402|"     One hundred adults with active joint disease and at least moderate pain will be enrolled in     this study to evaluate JBT-101, a synthetic endocannabinoid receptor type 2 (CB2) agonist and     an activator of the body's normal processes, to resolve innate immune responses without     immunosuppression. Participants will receive 2 doses by mouth of JBT-101 (three groups of     varying doses) or placebo for 84 days and will continue to be followed for an additional 28     days. Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then     every 4 weeks three times, for a total of six visits. The change in maximum daily pain     Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit.     Studies are also planned to evaluate tolerability and inflammation.   "
14674|NCT03093389|"     To investigate the tolerability and safety of four multiple-dose regimens of BIA 6-512 (25     mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers and to characterise the     steady-state pharmacokinetic profiles of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times     daily) in healthy volunteers.   "
14675|NCT03093376|"     Clinically significant anxiety affects up to 20% of preschool-aged children and often fails     to respond to currently available treatments. Emerging science suggests that increasing brain     capacity for effortful control (EC) may help anxious children to regulate emotion and     behavior to improve outcomes. Thus, in the proposed study, children will be trained on EC     tasks (including selective attention, response inhibition, etc.) to increase capacity for     effortful control (EC) over fear behaviors. To determine whether EC training improves brain     capacity to regulate fear, investigators will assess neurophysiological and behavioral     indices of effortful control and fear reactivity before and after this training.   "
14702|NCT03093025|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as     an adjunctive treatment for patients with major depressive disorder with an inadequate     response to current antidepressant Treatment (SSRI or SNRI).   "
14678|NCT03093337|"     Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive     disorders and unbalanced between brain and brainstem maturation of the neonatal period     involve an early deviant development for immature infants that will be cascaded through the     brain scaffolding and later development. The primary purpose is to determine whether the     Early Psychomotor Therapy Intervention Program improves development and behavior in very     preterm infants (VPI) at 24-month corrected age (CA).   "
14679|NCT03093324|"     This study will assess the gastrointestinal (GI) tolerability of ALKS 8700 in adult subjects     with RRMS   "
14680|NCT03093311|"     The occurrence of postoperative cognitive dysfunction (POCD) might be related to     intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated     with head rotation, elevation, flexion or extention that may affect blood brain inflow and     outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in     extreme head position with the development of cerebral ischemia or functional changes of     brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt     correction could modify the occurence of POCD after these procedures.   "
14681|NCT03093298|"     Examination of the molecular phenotype and composition of endocrine cells in the     gastrointestinal tract correlated to analyses of blood for hormones/analytes before and after     Roux-en-Y gastric bypass surgery in morbidly obese individuals both with and without type 2     diabetes   "
14682|NCT03093285|"     The aim of the study is to evaluate the incidence of sexual dysfunction in presence of     dysthyroidism and the impact of restoring euthyroidism on female sexual function   "
14683|NCT03093272|"     This research study is studying a combination of drugs as a possible treatment for     castration-resistant prostate cancer.      The interventions involved in this study are:        -  Docetaxel (a type of chemotherapy)        -  Apalutamide (the study medication, also known as ARN-509)        -  Prednisone (a corticosteroid given to prevent reactions to docetaxel).        -  Leuprolide acetate (also known as Lupron, a GnRH agonist or similar drug which is          standard of care, causes chemical castration which greatly lowers the level of          testosterone in the body)   "
14684|NCT03093259|"     This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming     at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in     subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant     to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month     follow-up period.   "
14685|NCT03093246|"     The aim of this randomized controlled clinical trial of superiority will be to evaluate the     effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily     supplementation over a period of 180 days as adjunct to non-surgical therapY of patients with     generalized aggressive periodontitis. Probing depth, clinical attachment level, gingival     index and concentration of microorganisms and cytokines at baseline, 3, and 6 12 months after     the procedure will be evaluated.   "
14686|NCT03093233|"     Intracerebral hemorrhage [ICH] is the most feared complication of oral anticoagulation [OAC],     yet therapeutic strategies are limited reflected by overall weak guideline recommendations.     Studies investigating acute interventions especially in patients with ICH taking     non-vitamin-K-oral-anticoagulants [NOAC] remain inconclusive. Further, acute management     issues in OAC-ICH patients (hematoma evacuation surgery, prevention of acute thromboembolic     events, intraventricular fibrinolysis) still need to be investigated. Therefore, this     observational study (RETRACE-II) represents the follow-up investigation to RETRACE     (German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage,     study-period 2006-2010, NCT01829581), now spanning a study-period from 2011 until 2015 with     19 participating tertiary care centers nation-wide in Germany. Data pooling of the two     RETRACE studies, altogether including more than 2500 patients treated at 22 centers over a 10     year period will allow statistically appropriate analyses of different outcomes.   "
14687|NCT03093220|"     Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity,     mortality and health care burden globally. Typing methods for discriminating different     clinical conditions of the same disease are essential to a better management of CAP.     Traditional typing systems based separately on clinical manifestations (such as PSI and     CURB-65), pathogens(bacterial types, virulence, drug resistance, etc) or host immune state     (immunocompetent, immunocompromised or immunodeficiency). Thus, they are barely able to     represent the real disease status nor to precisely predict the mortality.      As the development of multi-omic technologies, the relatedness of different phenotypes at a     molecular level have revolutionized our ability to differentiate among patients. Our study is     aimed at establishing a novel molecular typing method of CAP. Multi-omic (including genomics,     transcriptomes, and metabolisms) data obtained from enrolled CAP patients and isolated     pathogens would be integrated analyzed and interpreted. Tthe investigators believe that an     appropriate molecular typing method would lead to revolutionary changes in current     arrangements of CAP.   "
14688|NCT03093207|"     The aim of this randomized controlled clinical trial of superiority will be to evaluate the     effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily     supplementation over a period of 180 days as adjunct to surgical therapy of residual pockets     from patients with generalized aggressive periodontitis. Probing depth, clinical attachment     level, gingival index and concentration of microorganisms and cytokines at baseline, 3, and 6     12 months after the procedure will be evaluated.   "
14705|NCT03092986|"     Lung cancer is the leading malignancy worldwide and in Bangladesh. Most of the lung cancer is     of Non-small Cell Lung Cancer (NSCLC) type. For locally advanced NSCLC, combined modality     treatment is required. Concurrent chemo-radiotherapy and sequential chemo-radiotherapy are     the two recommended options. Sequential chemo-radiotherapy is mainly practiced in Bangladesh     due to its less toxicity profile. There is no head to head comparative study done which     focuses on the sequential chemotherapy regimens used in locally advanced NSCLC.      Hypothesis:      Null Hypothesis (H0): Sequential chemotherapy with cisplatin and vinblastine followed by     radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally     advanced NSCLC, there is no difference in loco-regional tumor control.      Alternative Hypothesis (HA): Sequential chemotherapy with cisplatin and vinblastine followed     by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally     advanced NSCLC, cisplatin and vinblastine is more responsive and effective in loco-regional     tumor control than paclitaxel and carboplatin.   "
14689|NCT03093194|"     The investigators designed a randomized controlled trial to evaluate whether perioperative     Vaginal preparation is superior to no Vaginal preparation in decreasing post CS endometritis.     Since CS is performed in about 30% of all births and infection complicates 6-11% of all CS     reducing the rate of this post CS complication can have a major impact not only on the     hospital occupancy and costs but also on the new mother experience and ability to face the     challenge that awaits for her with her newborn.      In this study patients will be randomly assigned into two groups. The experiment group will     not undergo any vaginal preparation. The control will undergo perioperative vaginal     preparation with antiseptic soap followed by chlorohexidine-alcohol Both groups will be     checked for cervical dilation with sterile gloves before surgery.      Primary outcome - signs of endometritis (e.g. erythema around surgical scar, discharge or     pain). Patients will be followed daily until discharge. A blood count will be drewn before     discharge to rule out signs of infection. Patients will be contacted 6 weeks after surgery by     telephone to inquire about any signs of infection, Emergency Room visits or ambulatory visits     to the doctor due to endometritis. The participants will be asked if they had positive skin     culture or other wound complications such as cellulitis, seroma or scar separation.      The investigators estimated that 1040 patients will have to enroll into the study, 520 in     each group in order to have 80% power to detect 50% difference in the endometritis rates     between the two groups with a two tailed α level of 0.05.      The data analysis was conducted according to the per-protocol principle.   "
14690|NCT03093181|"     This study is designed to evaluate the cosmetic benefit provided by twice daily application     of a developmental moisturising cream with niacinamide for 8 weeks in healthy female     participants with sensitive, oily, blemish-prone skin.   "
14691|NCT03093168|"     The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell     Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.   "
14692|NCT03093155|"     This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the     effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent     or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian     tube, or primary peritoneal cancer. Its primary objective is to assess whether adding     bevacizumab to ixabepilone improves progression-free survival in its target population. Study     participants will be stratified by (a) study site and (b) previous receipt of bevacizumab     prior to randomization.   "
14693|NCT03093142|"     This is a double blinded, randomized control trial with a pretest-posttest control and     interventional groups design. Both the assessor and participants are blinded to all     assessments and evaluations. All patients with subacute stroke undergo in-patient or     out-patient rehabilitation are screened initially by a series of screening test. Suitable     patients are assigned randomly to 3 groups respectively. Group 1 is the combined transcranial     direct current stimulation (tDCS) and neurofeedback group. Group 2 is the neurofeedback     group. Group 3 is the control group with sham neurofeedback training.   "
14694|NCT03093129|"     This is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant     artesunate given orally as a dose of 200 mg once a day for 14 days to patients with     histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment     with curative intent.   "
14695|NCT03093116|"     Phase 1 will assess safety and tolerability of TPX-0005 via a standard dose escalation     scheme, and determine the recommended phase 2 dose.      Phase 2 will assess safety and efficacy of TPX-0005.   "
14696|NCT03093103|"     SGLT-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of     decreasing blood glucose through an increase in glucosuria. These drugs inhibit the sodium     glucose transporter 2 (SGLT2) expressed at the luminal membrane of the proximal tubule.      SGLT-2 inhibition in type 2 diabetic subjects and in healthy volunteers shifts the threshold     for renal glucose excretion to lower levels. This effect is independent from insulin. The     inhibition of SGLT2 decreases HbA1C, systolic blood pressure and weight in diabetic subjects.     Recently, the EMPA-REG trial demonstrated a decrease in cardiovascular mortality and renal     endpoints in empagliflozin treated type 2 diabetic patients with established cardio-vascular     disease.      Because this novel hypoglycemic drug has unique and direct effects on renal tissue     metabolism, it is important to better examine its effects on the kidney. With this study, we     propose to explore the effects of empagliflozin on renal tissue oxygenation. Our hypothesis     is that SGLT-2 inhibition decreases renal cortical energy requirements with consequently an     increase in renal tissue oxygenation.   "
14697|NCT03093090|"     Poorly absorbed medications such as furosemide are common and recent experiments suggest that     improvement in absorption can occur if these types of medications are consumed with liquids     such as milk. The purpose of this study is to evaluate the absorption of furosemide in normal     adults when taken with bottled water, milk (Parmalat™ Whole Milk), baby formula (Similac     Pro-Advance™), or Ensure Plus™. These results will be used to make models that predict how     these liquids will affect drug absorption in children, potentially providing ways to improve     medication absorption in children.   "
14698|NCT03093077|"     The purpose of this study is to evaluate and compare implant kinematics of conventional     mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year     post-operatively.   "
14699|NCT03093064|"     Schizophrenia affects a significant proportion of the population and current levels of     understanding of the illness is inadequate to treat it effectively. Converging lines of     evidence suggest that neuroinflammation occurs in schizophrenia, and specifically     over-activity of brain-resident immune cells called microglia. It is however unclear whether     activated microglia play a primary role in schizophrenia, or whether this is a secondary     phenomenon of no pathophysiological significance. The investigators therefore plan to test     the effect of a monoclonal antibody (natalizumab) on psychotic symptoms in a cohort of first     episode psychosis patients.   "
14700|NCT03093051|"     This observation study evaluates the safety and effectiveness of UPT therapy in subjects     during either an indicated ventricular tachycardia ablation procedure or an ICD implant     procedure.   "
14703|NCT03093012|"     This study will collect retrospective and prospective clinical data regarding the Principal     Investigator's patient population to allow for data analysis seeking basic trends and to     prepare academic reports, including journal manuscripts and presentations for scientific     organizations.   "
14706|NCT03092973|"     Epistaxis is a very frequent emergency among adults and often needs specialised treatment in     an ENT-department. Among others, atherosclerosis is often named as a reason for an increased     risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined     the carotid intima media thickness via ultrasound in patients who were treated in the     ENT-department of the University Hospital of Zurich.   "
14707|NCT03092960|"     The purpose of this study is to test a flexible lifestyle program designed to help Latino men     make healthy lifestyle changes to lower their risk of developing diabetes and heart disease.     The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el     Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being     and decrease chronic disease risk).   "
14708|NCT03092947|"     Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to     determine AKI risk are lacking. Renal functional reserve (RFR), the capacity of the intact     nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration     capacity. We hypothesized that preoperative RFR would predict postoperative AKI.   "
14709|NCT03092934|"     This two-part study consists of a Phase 1 dose escalation study in participants with locally     advanced or metastatic solid tumors, and a Phase 2 portion in up to 3 cohorts with either     Small Cell Lung Cancer, Breast Cancer and/or one other solid tumor type   "
14710|NCT03092921|"     This investigation is designed to evaluate the performance as well as the patients overall     acceptance of the seal/mask.   "
14711|NCT03092908|"     Kidney stones are one of the most common disorders of the urinary tract and cause a great     deal of morbidity and economic loss. Because of the high recurrence rate, researchers are     interested in finding medicinal therapies to prevent kidney stone recurrence. Vinegar is     consumed worldwide as a food condiment and preservative. The mature vinegar, also called     black vinegar, is an inky-black vinegar aged for a malty, woody, and smoky flavor. It is     popular in the north of China as a dipping sauce, particularly for dumplings.      Some studies promote vinegar for its medicinal properties, as a tonic which may lower blood     pressure and cholesterol level. Our national epidemiological data in China showed that     consumed more mature vinegar was associated with decreased risk of kidney stones formations.     Furthermore, our previous in vivo study found that mature vinegar could inhibit renal calcium     oxalate crystals formation in rat model. These findings inspire us to clarify the     nephrolithiasis prevention effect of mature vinegar in a clinical trial. In this study,     investigators would like to examine the efficacy of mature vinegar prophylaxis for preventing     recurrent calcium oxalate nephrolithiasis.   "
14712|NCT03092895|"     This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of     SHR-1210 in combination with Apatinib or FOLFOX4 regimen in subjects with Advanced PLC.      Participants with advanced PLC who failed or intolerable to prior systemic therapy will be     treated with SHR-1210 plus Apatinib; Participants with advanced PLC who have never received     prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 regimen.   "
14713|NCT03092882|"     The Digital Self-Management Program for Medicare Advantage Members with Type 2 Diabetes -     Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized     controlled trial that aims to evaluate the impact of the Digital Self-Management Program on     A1c levels for individuals with uncontrolled Type 2 diabetes.   "
14714|NCT03092869|"     This study aims to assess whether mobilization of the ankle and foot produces significant     improvements in the balance of the elderly.      To this end, a randomized study was designed with a control group that performs     proprioception exercises and an experimental group that also performs a mobilization of the     ankle and foot joints.   "
14715|NCT03092856|"     This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody     PF-04518600 work in treating patients with kidney cancer that has spread to other parts of     the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made     from living organisms that may may stimulate the immune system in different ways and stop     tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody     PF-04518600 may work better in treating patients with kidney cancer.   "
14716|NCT03092843|"     Investigators aim to assess changes in exercise capacity and quality of life after septal     myectomy in patient with hypertrophic cardiomyopathy.   "
14717|NCT03092830|"     The objective is to find genes which are responsible for the appearance of skin tumors (sCC,     BCC) and it will be the basis for prediction of the disease and response to the treatment   "
14718|NCT03092817|"     The investigators will conduct a randomized, double blind, placebo controlled trial of     adjunctive dexamethasone in the initial (6-8 weeks) treatment of tuberculous meningitis in     Vietnamese adults. The trial will address a primary hypothesis in all enrolled patients, and     a secondary hypothesis in a sub-group of enrolled patients who develop anti-tuberculosis     drug-induced liver injury (DILI). The primary hypothesis is adjunctive dexamethasone     increases survival from TBM in HIV co-infected adults. The secondary hypothesis is current     guidelines for the management of anti-tuberculosis drug-induced liver injury in those with     TBM result in the premature interruption of rifampicin and isoniazid (the critical active     drugs in early therapy) and are thereby placing participants at risk of poor outcomes.   "
14719|NCT03092804|"     With the advent of the aging society, dementia becomes the focus of common people. As for the     neurodegeneration dementia, no disease modifying treatments have been discovered. Idiopathic     normal pressure hydrocephalus (iNPH) is considered as one of reversible dementia, which can     be hint by the surgery. In addition, dementia of iNPH is the typical subcortical dementia.     Therefore exploring the pathogenic mechanism is conducive to the early diagnosis and     treatment. This research is to monitor the changing of iNPHGS, cognitive function, walking     ability as well as brain construction imaging and neural network before and after     ventriculo-peritoneal shunting in order to demonstrate the pathogenesis of triads. In the     process, the supplementary test, for instance, CSF tap test, will be validated the predictive     value.   "
14757|NCT03092310|"     The purpose of this pilot study is to establish that closed-loop insulin delivery with a     target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms     with a trust index of the predicted glucose value is safe and effective, to analyze and learn     to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to     inform a future larger study.   "
14720|NCT03092791|"     The purpose of this study is to select the optimal antigen content of the three Sabin     poliovirus strains (types 1, 2, and 3) entering the composition of the stand-alone trivalent     Sabin-based inactivated poliomyelitis vaccine (sIPV) to take forward into advanced stage     studies. The selection will be carried out comparing the three sIPV study arms based on the     safety and tolerability profile after each dose of primary immunization and the immune     response to poliovirus types 1, 2, and 3 for both Sabin and Salk strains, after the final     dose of a three dose primary immunization series (Day 85).   "
14721|NCT03092778|"     The purpose of this study is to assess the efficacy of cryoablation therapy for the treatment     of mild to moderate obesity and test the safety (good and bad effects) of this procedure. The     vagus nerve transmits hunger signals from the stomach to the brain, and in response transmits     stomach expansion signals from the brain to the stomach. Investigators believe that by     interrupting this communication, participants could experience less hunger and in turn lose     weight.   "
14722|NCT03092765|"     This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group     comparison study in primary biliary cholangitis participants inadequately responding to     ursodeoxycholic acid.   "
14723|NCT03092752|"     Appropriate use of oral antidiabetic drugs (OADs) including dose-reduction is important for     patient's safety in T2DM patients with renal impairment (RI). However, there are insufficient     data on dose adjustment in accordance with the prescription pattern and the risk of RI of     OADs, in particular DPP-4 inhibitors, in clinical practice in Japan. Therefore, we will     investigate OADs usage conditions and dose selection in T2DM patients with RI in clinical     practice in Japan   "
14724|NCT03092739|"     The primary purpose of this non-interventional, multinational study is to assess the     feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for     histological samples obtained from participants with any stage of non-small cell lung cancer     (NSCLC) or small cell lung cancer (SCLC).   "
14725|NCT03092726|"     The purpose of this study is to assess analgesic efficacy of ASP8062 relative to placebo as     well as the safety and tolerability. This study will also assess the treatment differences in     physical function as well the improvements in overall subject status (e.g., fibromyalgia     symptoms, global functioning) of ASP8062 relative to placebo.   "
14726|NCT03092713|"     A considerable number of patients with mild and moderate traumatic brain injury (TBI)     experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their     capacity to return to work (RTW). Although several studies have described medical,     psychological and work-related factors that predict RTW after TBI, well-controlled     intervention studies regarding RTW in this group are scarce. Furthermore, there have     traditionally been weak collaborations among rehabilitation services in the health sector,     the Labor and Welfare Administration (NAV), and the work-places.      The current project proposal describes an innovative randomized controlled trial (RCT) which     will explore the effect of combined manualized cognitive rehabilitation efforts and supported     employment in real-life competitive work settings for patients who have not returned to work     8 weeks post-injury. The project combines the rehabilitation and vocational science     perspectives; it involves multidisciplinary collaboration, and explores the efficacy of     increased cross-sectorial collaboration between specialized health care services and the     welfare system. If the intervention proves efficient, the project will further describe the     cost-effectiveness and utility of the program, and thereby provide important information of     use for policy makers. In addition, the study aims at generating knowledge on the RTW-process     both for the persons with TBI, and their workplaces, and to disseminate this knowledge in     order to create new multidisciplinary and collaborative practices. The project has potential     to generate knowledge of relevance for other patients with neurological deficit.   "
14727|NCT03092700|"     To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial     emotions recognition and smile production, by improving the emotional dimension of dyspnoea     in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary     rehabilitation improves emotional cognition, using facial emotions recognition and smile     production, by improving the emotional dimension of dyspnoea in patients with chronic     obstructive pulmonary disease (COPD).   "
14729|NCT03092674|"     This randomized phase II/III trial studies how well azacitidine with or without nivolumab or     midostaurin, or decitabine and cytarabine alone work in treating older patients with     previously untreated acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used     in chemotherapy, such as azacitidine, decitabine, and cytarabine, work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere     with the ability of cancer cells to grow and spread. Midostaurin may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with     or without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer     cells.   "
14730|NCT03092661|"     To define preliminary reference (normative) limits for healthy, newborn baby oxygen     saturation parameters using the Masimo Radical 7® monitor.      To assess protocol feasibility in terms of acceptability to parents and infants.      To inform the design of a future larger study where reference limits will be fully defined     across a wider gestational age group.   "
14731|NCT03092648|"     Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema     with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease,     chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in     COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This     study intends to carry out an open, single-armed, phase I/II clinical trial to investigate     whether bronchial basal cells can regenerate damaged lung tissue. During the treatment,     bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro.     After careful characterization, cultured cells will be transplanted autologously into the     lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored     by measuring the key clinical indicators.   "
14732|NCT03092635|"     The purpose of this study is to look at the effects that the study drugs (metformin and OPC)     have on AGE levels in patients with ER+ metastatic breast cancer.   "
19633|NCT03028584|"     This is a two part observational study evaluating the feasibility of implementing an     EHR-based model within a community oncology practice.   "
14733|NCT03092622|"     Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in     the blood are at risk of developing pulmonary hypertension and strain on the right side of     the heart, both of which are known to increase symptoms and worsen prognosis It is not fully     established whether interval exercise training in patients with severe COPD and concomitant     low oxygen levels is beneficial.      This study aims to evaluate the effects of aerobic interval exercise training in patients     with severe COPD and low oxygen levels in the blood, with a particular emphasis on such     effects on the cardiovascular system and pulmonary circulation.   "
14734|NCT03092609|"     Anxiety disorders are one of the most common psychological disorders. Underlying anxiety is     an increased attentional bias to threat, which has been identified as a causal contributor in     the development of anxiety. Given this causal relationship, attention bias modification was     introduced as a treatment option where anxiety is reduced by training individuals to direct     their attention away from threat and thereby decreasing anxiety. Over a decade of research     using this approach, called attention bias modification (ABM), suggests that overall the     approach is effective in reducing anxiety. Although ABM appears to be a very promising     treatment option for anxiety, there are several factors limiting the effectiveness of ABM.     These include the recognition of individual-level needs and a known underlying mechanism of     action by which ABM is effective. Neuroimaging evidence suggests that attentional bias to     visual threat is associated with a network of brain regions including the amygdala, anterior     cingulate cortex, and visual cortex. In human participants, experience-dependent     neuroplasticity is visible in voxel-based morphometry based measures of gray matter volume     following training. Recently, voxel-based morphometry measures of gray matter volume have     been linked to dendritic spine density—a known cellular mechanism for learning-related     neuroplasticity. Thus, voxel-based morphometry measures are ideally suited to measure     learning-related neuroplasticity following attention bias modification. In this proposal     participants' level of attentional bias, anxiety, and gray matter volume will be measured     before and after completing six weeks of attention bias modification training (N = 50) or     attention control training (N= 50). The proposal aims to (1) establish that pre-treatment     bias predicts variability in gray matter volume in the extended amygdala and anterior     cingulate cortex, (2) assess the extent to which reduced extended amygdala and anterior     cingulate cortex gray matter volume following ABM underlies reductions in attentional bias     and anxiety, and (3) Establish pre-treatment bias as a predictor of successful ABM as     measured by reduced bias, reduced anxiety, and reduced gray matter volume in the extended     amygdala and anterior cingulate cortex. Consistent with the objectives of the AREA grant and     NIMH's focus on identifying and validating new targets for treatment development that     underlie disease mechanisms, the current proposal plans to involve students at a rural     primarily undergraduate university in a research project aimed at establishing     neuroplasticity in the extended amygdala and anterior cingulate cortex as a target mechanism     for ABM training outcome, which could be used to objectively track training-related outcomes     in anxiety treatment.   "
14735|NCT03092596|"     Substance abuse and dependence is highly prevalent among people living with HIV and     significantly exacerbates morbidity and mortality and accelerates HIV disease progression.     Antiretroviral therapy (ART) has been the single most important treatment for slowing disease     progression. ART adherence and HIV primary care are affected by a complex array of factors in     the context of lives impacted by socioeconomic, psychological, and health challenges. Drugs     and alcohol play a major role in non-adherence, engagement in care, and poor health outcomes     among HIV-infected persons. While evidence is unequivocal that substance use treatment     improves health outcomes, systems of care for the detection and treatment of substance abuse     and dependence remain fragmented. Integrated approaches are key to the delivery of optimal     care. Pragmatic or effectiveness trials can provide the best evidence about clinical practice     to inform practitioners and policy makes about the most clinically and cost effective     treatment to inform dissemination on a wider scale at the organizational and public health     levels. The goal of this trial is to develop and test a comprehensive, integrated program to     detect and reduce substance abuse and in turn, to improve ART adherence and HIV, substance     use and associated health outcomes among HIV-infected patients. This trial will test the     effectiveness of the intervention using a stepped wedge trial design to sequentially     implement a screening tool and training of patient health navigators at HIV clinics in NYC.   "
14736|NCT03092583|"     The aim of this project is to quantify global DNA methylation in patients with Ankylosing     Spondylitis or Axial Spondyloarthritis as compared with control subjects.   "
14737|NCT03092570|"     This study will assess the putative advantages of cerebellar stimulation on motor learning     abilities of stroke patients. In order to have a control group to refer to, the effect of     cerebellar stimulation on healthy young and old participants will also be assessed.   "
14738|NCT03092557|"     This study is designed to assess the feasibility of the measurement of local pleural strain     at 4 different anatomical sites.      The secondary objectives of the study are:        -  To assess intra- and inter-observer variability in the measurement of local pleural          strain        -  To identify the strain parameters demonstrating the most clinically relevant and the          most significant correlation with a change in tidal volume      Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the     determination of local pleural strain in 4 predetermined pulmonary areas.   "
14739|NCT03092544|"     The purposes of this study is to identify types of bacteria that reside in the intestine of     healthy individuals and compare them to individuals with Multiple Sclerosis (MS). There has     been a lot of research in other autoimmune diseases which has demonstrated the importance of     stomach gut bacteria because it has an important relationship with the immune system, but     this has never been studied in MS patients. In this study investigators aim to show     differences in the gut bacteria between healthy individuals and those with MS, to provide a     basis for future research studying how diet can affect MS through its effects on the gut     bacteria.      Additionally, this study will be looking at the effects of dimethyl fumarate on cerebrospinal     fluid, plasma and MRI in MS patients taking dimethyl fumarate as compared to those with MS     not on dimethyl fumarate or other disease modifying therapy and those who do not have MS     (normal controls).   "
14740|NCT03092531|"     This randomized control trial is to test the efficacy of a stepped-care adaptive     Antiretroviral Therapy (ART) adherence intervention (Positive STEPS) for HIV infected     adolescents and young adults, ages 16 to 24. Stepped care is a healthcare delivery model in     which the least resource intensive part of an intervention is delivered first, and only those     who do not improve then receive the high intensity, more resource intensive part of an     intervention.   "
14758|NCT03092297|"     The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a     feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to     ultimately personalize blood transfusion decisions in the ICU.   "
14759|NCT03092284|"     The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem     Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate     the regenerative capacity of the CSCC_ASC treatment.   "
14841|NCT03091205|"     It's hypothesized that a mean and range distance from the cavo-atrial junction to the area     where there is complete loss of conductive tissue can be measured to better inform surgeons     performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where     visualization and mapping of cavo-atrial junction is possible could be entered into the study     if they meet the inclusion/exclusion requirements.   "
14741|NCT03092518|"     Background:      Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs.     Researchers want to see if a new treatment helps. It is surgical removal of the cancer and     heated chemotherapy delivered to the abdominal cavity called HIPEC.      Objective:      To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve     survival in people with gastric cancers.      Eligibility:      People ages 18 and older with gastric cancer who can have most tumors surgically removed      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood, urine, and heart tests        -  Scans        -  Tissue sample from previous surgery        -  Endoscopy with biopsy: A tube with a camera goes through the mouth and into the stomach.          It and takes a sample of stomach tissue. Participants might may get medicine to make          them drowsy.        -  Laparoscopy: Small cuts are made in the abdomen. A thin tube with a light and camera is          inserted into the abdomen. Participants sleep through the procedure.      Participants will stay in the hospital. They will have:        -  Surgery to remove as many tumors as possible.        -  HIPEC for 60 minutes: Two thin tubes are put into the abdomen. Two chemotherapy drugs          are given through one tube. They are drained out through another at a temperature a few          degrees above normal body temperature. Another drug is given in a vein.      Recovery for 7-21 days: Participants will have tubes in their stomach and bladder and IVs for     a few days. They will get pain medicine, IV fluids, antibiotics, and blood transfusions as     needed.      Participants will have visits every few months for 3 years, then one a year. Visits include     physical exam, blood tests, and scans. They also include dietary assessment and questions.   "
14744|NCT03092479|"     Prospective, randomized pilot trial to evaluate a comprehensive postoperative behavioral     support intervention using a 4-month bi-weekly program in 40 bariatric surgery patients (all     surgical procedure types) from the Geisinger Health System Center for Nutrition and Weight     Management compared to 40 usual care patients.   "
14745|NCT03092466|"     Assess if the addition of an early femoral nerve block (performed within 2 hours from the     admission in emergency department through a femoral nerve catheter) in the elderly patients     (> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by     CAM 3Ds test, compared to the traditional systemic pain therapy.   "
14746|NCT03092453|"     Single arm open label trial assessing the safety and tolerability of mDC3/8 Vaccine (Primer     and Booster) in subjects with stage III and stage IV melanoma followed by treatment with     Pembrolizumab.   "
14747|NCT03092440|"     The use of simulation in medical education has been associated with positive results in the     acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful     educational tools since they allow both theory and practice training for an important number     of learners, simultaneously. However, few studies have evaluated the validity and     effectiveness of serious games.      Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a     serious game named LabForGames Warning for nursing students with the following learning     objectives: to recognize and to address the degradation of a patient's clinical condition and     to work on the issue of inter-professional communication. The aim of the present study is to     determine content and construct validities of the LabForGames Warning serious game before     its use as a healthcare professional training tool.   "
14749|NCT03092414|"     The newly developed linked color imaging (LCI) system (FUJIFILM Co.) creates clear and bright     endoscopic images by using short-wavelength narrow-band laser light combined with white laser     light on the basis of BLI technology. This system can obtain bright endoscopic images even at     a distant view because LCI has more intense white light than the short-wavelength narrow-band     laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal     surface and the patterns of the mucosa. Therefore, LCI may facilitate the detection of     gastric mucosal lesions. Further studies are needed to confirm the clinical utility of LCI.   "
14750|NCT03092401|"     Hepatopulmonary Syndrome is a respiratory complication of liver cirrhosis defined as a triad:     hypoxemia (PaO2 < 80 mmHg in room air), chronic liver disease and intrapulmonary     vasodilatations. Its prevalence varies between 4 and 32%. Numerous treatments have been tried     but the only efficient therapy to cure the syndrome is liver transplantation. Without     transplantation it is associated with a higher mortality which is the reason why     hepatopulmonary syndrome patients have a higher priority to transplantation. However it     appears in some restricted studies that hepatopulmonary syndrome is associated with more     postoperative complications (infections, vascular and biliary complications, prolonged length     of mechanical ventilation…).      The investigators hypothesised that hepatopulmonary syndrome patients have more postoperative     complications after liver transplantation than non hepatopulmonary syndrome patients matched     on age, MELD (Model for End-Stage Liver Disease) score, comorbidities, perioperative     transfusion and noradrenaline doses.   "
14751|NCT03092388|"     This study aims to investigate the influence of a potential leg fluid shift (LFS) in patients     with chronic heart failure (CHF) and obstructive sleep apnea (OSA) or central sleep apnea     (CSA).   "
14752|NCT03092375|"     The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment     experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not     complete the prescribed duration due to adverse event or any reason other than for non/poor     compliance. Subjects will be randomized to 12 or 16 weeks of treatment.   "
14753|NCT03092362|"     Heart rate variability (HRV) in patients with atrial fibrillation (AF) is hardly studied.     Though a reduced HRV in patients with heart failure and reduced ejection fraction (HFrEF) has     been associated with poor prognosis. Data on HRV in AF-patients without a reduced ejection     fraction is lacking. We hypothesize that those patients with persistent atrial fibrillation     and larger beat-to-beat variability would be more symptomatic than does those with smaller     HRV. To asses this theory we intend to perform a prospective observational trial. Symptoms of     Atrial fibrillation will be assessed using Quality of Life questionnaires and 6 minutes     walking test. Heart rate variability will be assessed using 24 hour Holter ECG monitoring.      The correlation between symptoms and heart rate variability will be then assessed.   "
14754|NCT03092349|"     The primary aim of the present study is to investigate whether the optimisation of LVSV in     addition to the optimisation of AV-D and VV-D when using the device-based sensor technology     mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive     measurements are intended to evaluate hemodynamic differences between the different     stimulation configurations using the Finapres® method.   "
14755|NCT03092336|"     Introduction: the peripheral obstructive arterial disease is an condition that affects around     15% of the world population interfering in muscle strength, life quality and functional     capacity of patients.   "
14756|NCT03092323|"     This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant     radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent     radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration     of pembrolizumab will be one year in the experimental arm.   "
14760|NCT03092271|"     This randomized controlled trial will evaluate two approaches to achieving the aspirational     goal of Zero Suicide within a health system: 1) Zero Suicide Best Practices initiated through     a zero suicide quality improvement initiative within a health system; and 2) Zero Suicide     Best Practices plus an innovative stepped care for suicide prevention intervention for     adolescents and young adults that matches treatment intensity with risk levels for     suicide/self-harm. ..   "
14761|NCT03092258|"     Conduct a questionnaire survey of palliative care professionals including doctors, nurses and     social workers currently working within the West Midlands to establish how much the     palliative care community in the West Midlands engage in preparing patients for their digital     legacy and find out if there is a further education need in this community about digital     legacy.   "
14762|NCT03092245|"     Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients     with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial   "
14763|NCT03092232|"     The current study is the first clinical trial proposed with PF-06865571. It is designed to     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of     single doses of PF-06865571 to healthy adult subjects.   "
14764|NCT03092206|"     Investigation of possible changes in insulin sensitivity in healthy volunteers taking the     following HIV treatment combinations: F/TAF (group 1) as compared to E/C/F/TAF (group 2) as     compared to R/F/TAF (group 3). The measurement of insulin sensitivity will be performed in 30     HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14±2 days of     treatment. The volunteers will be randomly assigned to one of the three groups. Changes in     insulin sensitivity will be measured by golden standard hyperinsulinemic euglycemic clamp     (HEGC) technique, using glucose and insulin infusion as diagnostic agents   "
14765|NCT03092193|"     The family of cytochrome P450 (CYP) is the most important drug metabolizing enzymes which     contributes to the metabolism of a large proportion of drugs in humans. Some CYP450 enzymes     reduce or alter the pharmacodynamic activity of many drugs and are involved in oxidative     metabolism and elimination of many drugs commonly used by the population. Polymorphisms in     CYP2C8 and CYP2C9 are common in different populations around the world and genetic variations     in these alleles can cause decreased enzyme activity to nonsteroidal anti-inflammatory drugs     (NSAIDs) such as celecoxib, diclofenac, ibuprofen, indomethacin, lornoxicam, meloxicam,     valdecoxib, piroxicam, tenoxicam and naproxen. This compromise the bioavailability of the     drug can alter the pharmacokinetics of these drugs and patients with mutations in these genes     can exhibit increased plasma concentrations of values and areas under the curve (AUC), in     addition to decreased clearance of drugs. Associations between NSAIDs and gastric protectors     or proton pump inhibitors (PPIs) have become common nowadays, especially in patients who make     chronic use of these drugs. Naproxen associated to esomeprazole, a proton pump inhibitor     (PPI), was launched in the market recently and its application in acute pain is not yet     elucidated. Esomeprazole suffers strong influence of CYP2C19 (hepatic drug-metabolizing     enzyme that degrades PPIs). In patients with high enzyme activity of the CYP2C19, the drug     can suffer high enzymatic degradation, and its diminished effect. Moreover, in patients with     low enzyme CYP2C19 activity, the effect of acid inhibition by PPIs can be very strong.   "
14766|NCT03092180|"     As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies     with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at     disease onset.      This scheme is an internal routine protocol of our Service.   "
14767|NCT03092167|"     Physical training may improve physical capacity and health parameters in various systemic     autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present     study will assess the role of an exercise training program in patients with idiopathic     inflammatory myopathies.   "
14768|NCT03092154|"     The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is     controversial. Therefore, the aim of the present study is to assess clinically and laboratory     the impact of lipid-lowering agents in this population.   "
14769|NCT03092141|"     Physical training may improve physical capacity and health parameters in various systemic     autoimmune diseases. Therefore, the present study will assess the role of an exercise     training program in patients with relapsing polychondritis.   "
14770|NCT03092128|"     For patients of GIST (Gastrointestinal Stromal Tumor), Imatinib has been widely used in GIST     with KIT or PDGFRA sensitive mutations. From clinical points of view, individual differences     often occur between different patients, leading diverse effect in ADR and drug effect.     Meanwhile, the drug effect and adverse drug reaction was significantly influenced by the     pharmacokinetic factors and pharmacodynamic and other factors. In this research, we try to     establish a more sensitive method to detect sensitive mutations in plasma and discover the     correlation between somatic and germline mutations, plasma trough concentration and drug     effect, the association between ADME-associated SNP, Target/Receptor/Pathway-associated SNP,     trough concentration and TKI adverse effect. Furthermore, in vivo and in vitro research is     also crucial for rational explanation for these clinical phenomenon.   "
14771|NCT03092115|"     This study will help determine feasibility, acceptability, and preliminary efficacy of an app     for HIV medication adherence over a 3-month period. Participation is 3 months consisting of     two study visits: An initial study visit and a 3 month follow up visit with both visits     lasting about 60-90 minutes. The participant must use the study application (app) at least     once daily, and at study visits, must complete surveys.   "
14772|NCT03092102|"     The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment     drug HEC585 in Healthy Male and Female Subjects   "
14773|NCT03092089|"     This study evaluates what effect sonothrombolysis may have on spontaneous reperfusion,     microvascular obstruction, left ventricular function and infarct size in patients presenting     with their first ST-segment Elevation Myocardial Infarction.   "
14774|NCT03092076|"     This study is a open and single center clinical trial in healthy Chinese.The objective of the     study is to clarify the pharmacokinetics characteristics and antiplatelet effects of     ticagrelor in Chinese and to investigate the impact of genotype.   "
14786|NCT03091920|"     To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD)     effects of 2 treatment regimens of IW-1973 Tablet (40 mg per day) administered orally for 2     weeks to patients with stable type 2 diabetes mellitus and hypertension.   "
14775|NCT03092063|"     The overall objective of this study is to construct an adaptive intervention that integrates     family members and patients as partners in care while promoting diabetes self-management for     Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based,     culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to     help determine what sequence of intervention strategies work most efficiently and for whom.   "
14776|NCT03092050|"     Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias     is a serious public health problem. This is a randomized, controlled, single-blind pilot     clinical trial of 50 depressed caregivers, to determine the efficacy and mechanisms of group     therapy for depressed dementia caregivers.   "
14777|NCT03092037|"     The proposed study will investigate the relationship between genetic variants and serum     contraceptive hormone levels, specifically the progestin etonogestrel. This study will     provide the foundation for future pharmacogenomic investigations of more commonly used     contraceptive methods with higher failure rates.   "
14791|NCT03091855|"     Patients will be screened at Intermountain Medical Center and at Intermountain affiliated     anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that     undergo a standard of care, clinically approved, left atrial appendage closure will be     considered for study. All patients will be followed for 24 months, and will be assessed at     the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits     deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory     tests and will complete 6 standard, validated questionnaires at each follow-up visit, except     at the 3-month visit when only one questionnaire will be administered.   "
14792|NCT03091842|"     This randomized phase II trial studies how well exercise intervention works in targeting     adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer     survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the     risk of cancer recurrence related to being overweight or obese.   "
14778|NCT03092024|"     The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established     by researchers, health care providers, and people living with scleroderma from Canada, the     USA, and Europe. The objectives of SPIN are (1) to assemble a large cohort of scleroderma     patients to complete outcome assessments regularly in order to learn more about important     problems faced by people living with scleroderma and (2) to develop and test a series of     internet-based interventions to help patients manage aspects of scleroderma, including hand     limitations.      In the SPIN-HAND feasibility trial, SPIN Cohort participants with at least mild hand function     limitations and an indicated interest in using an online hand exercise program will be     randomized to be offered the SPIN hand exercise program or to usual care only. The core SPIN     hand exercise program consists of 4 modules that address specific aspects of hand function,     including Thumb Flexibility and Strength; Finger Bending; Finger Extension; and Wrist     Flexibility and Strength. The program also integrates tools to support key components of     successful self-management programs, including goal-setting.      The aim of the SPIN-HAND feasibility study is to collect data to assess the feasibility of     the steps that need to take place as part of the main trial; required resources; and     scientific aspects (e.g., withdrawal rate, outcomes measures). Data will be used to determine     whether it is feasible to carry out the main study or whether changes need to be made before     conducting a full-scale RCT of the SPIN-HAND program.   "
14779|NCT03092011|"     The purpose of this study is to determine whether a medication, Clonidine can reduce the     number of days a baby spends in the hospital and the number of days of medical treatment of     withdrawal from Neonatal Abstinence Syndrome (NAS) as compared to Morphine Sulfate (used in     routine care) .   "
14780|NCT03091998|"     The worldwide use of left ventricular assist devices (LVAD), which is mechanical device to     improve hemodynamic function, has improved the outcomes of severe heart failure (HF) patients     leading to the continued annual increase in the number of LVAD implantations. However LVAD     support still results in major complications such as renal failure or gastrointestinal     bleeding. The investigators hypothesize that such major complications may be due to     endothelial dysfunction induced by the lack of pulsatility, which may be improved by an     innovative designer natriuretic peptide, CD-NP. They have demonstrated its favorable actions     in animal models as well as humans, and tested its safety in LVAD patients. They hypothesize     that CD-NP will have renal and endothelial protective actions through its receptor GC-A and     GC-B. Thus, the investigators will test their hypothesis with a highly translational approach     to examine CD-NP's role in endothelial and renal protection.      The aim is to determine safety and tolerability together with cGMP activating, neurohumoral     modulating and renovascular protective properties of chronic subcutaneous delivery of CD-NP     compared to placebo in stable LVAD patients for 3 days.   "
14781|NCT03091985|"     The purpose of this study is to investigate the efficacy of breast drainage of the healthy     breast with the new Medela pump set breast shield (Brownie).      The objective of the study is to verify the Brownie breast shield to be non-inferior to the     current PersonalFit breast shield in emptying the healthy lactating breast.   "
14782|NCT03091972|"     Linear ablation is frequently used in the procedure for persistent atrial fibrillation.     However, it has a limitation because of technical difficulty. Incomplete block is common and     an important cause of atrial tachycardia.      The association between contact force values and successful linear block has not been     revealed yet. We aim to the effectiveness and safety of linear ablation by using CF sensing     catheter.   "
14783|NCT03091959|"     The study looks to evaluate the device diagnostic data obtained from (all the Cardiac Rhythm     and Heart Failure (CRHF) devices of medtronic having the Cardiac Compass® and OptiVol®     diagnostic feature) these devices to identify trends during clinical events that will help     early detection and prevention of cardiovascular and other comorbid conditions. (i.e. Heart     failure(HF), Atrial Fibrilation,COPD, Renal dysfunction (RD), Diabetes etc.)   "
14784|NCT03091946|"     The purpose of this study is to compare the glucose, insulin and subjective hunger responses     elicited by oats with additional dried fruits, nuts and seeds soaked overnight in skim milk     and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds     cooked just prior to its consumption.   "
14785|NCT03091933|"     This study will evaluate the safety of infusing an anti-MiHA T cell line in patients     suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell     transplantation from a matched donor.   "
14787|NCT03091907|"     Aim      The aim of this study is to determine consequences at school age of the diagnosis of NEC in     the neonatal period.      Methods      This is a case-control study, with case-group being children born in Denmark with a history     of NEC and control-group being age-, gestational age- and year of birth matched children born     in Denmark with no history of NEC.      Primary outcome      Abnormal or borderline 'total difficulties score' in the     strenghts-and-difficulties-questionnaire as assessed by parents.   "
14788|NCT03091894|"     studying the effect of adding dexmedetomidine intravenous infusion to propofol intravenous     infusion during sedation for drug induced sleep endoscopy   "
14789|NCT03091881|"     Diabetic Parturients are exposed to intraoperative hypotension after spinal anesthesia and we     proposed that intravenous Granisterone 1 mg will attenuate the hypotension occurred with     spinal block during Cesarean sections.   "
14790|NCT03091868|"     To investigate the effect of rising oral single-doses of BIA 6-512 (25 mg, 50 mg, 100 mg and     200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of     immediate release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) or with a single-dose of     Sinemet® 100/25 plus a single-dose of entacapone (Comtan®) 200 mg and to assess the     tolerability and safety of rising single oral doses of BIA 6-512 when administered in     combination with a single-dose of Sinemet® 100/25 or with a single-dose of Sinemet® 100/25     plus a single-dose of Comtan® 200 mg.   "
14793|NCT03091829|"     Multicentric, prospective, non-interventional observational study with two parts:        1. A register of quality assurance within the recertification of clinics        2. An extended register with scientific protocol.   "
14794|NCT03091816|"     This pilot clinical trial studies the changes in dynamic perfusion computed tomography images     before, during, and after stereotactic body radiation therapy in patients with stage I-II     non-small cell lung cancer that has not spread to other parts of the body. Diagnostic imaging     procedures, such as dynamic perfusion computed tomography, measure blood flow through tumors.     Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays     directly to the tumor using smaller doses over several days and may cause less damage to     normal tissue. Giving dynamic perfusion computed tomography images before, during, and after     stereotactic body radiation therapy may help better understand how radiation therapy works to     stop tumor growth in patients with non-small cell lung cancer.   "
14795|NCT03091803|"     This randomized pilot clinical trial studies quantitative susceptibility mapping (QSM) and     regional dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) permeability using     golden-angle cartesian randomized time-resolved (GOCART) technique in evaluating regional     gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate     dimeglumine or gadoterate meglumine. MRI diagnostic techniques such as, QSM and DCE MRI, may     help to gather information regarding brain changes associated with gadolinium deposits during     8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.   "
14796|NCT03091790|"     Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on     when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half     are repaired using biologic mesh while half are repaired using synthetic mesh. The     investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open     ventral hernia repair is associated with decreased risk of major complications one year after     surgery.   "
14797|NCT03091777|"     This research study is being done to compare the safety and efficacy of GDC-229 (test drug)     against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to     establish that these two drugs work better than placebo in subjects with BV.   "
14798|NCT03091764|"     This project will develop and evaluate a patient-reported symptom index to assess the impact     of treatment for non-muscle invasive bladder cancer on patient burden, toxicity, symptoms and     side effects. The symptom index will provide a method for assessing treatments from the     patient's perspective; help healthcare professionals make better informed treatment     decisions, and provide a method to be able to effectively evaluate treatments for non-muscle     invasive bladder cancer.   "
14799|NCT03091751|"     The goal of this non-randomized, multi-center study in subjects with severe hereditary     haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX     in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.   "
14800|NCT03091738|"     To study the effect of ramelteon, a melatonin receptor agonist, on sleep quality, duration     and cognitive function in cirrhotics with insomnia.      Patients with cirrhosis have difficulties with their sleep quality, which adversely affects     their health-related quality of life. It is assumed the sleep disturbances are related to     hepatic encephalopathy (HE) in these patients. However, several recent reports have indicated     that this is not a perfect concordance and that cognition is not related to sleep     disturbance. The mechanism for this change is not clear, although there is evidence of     melatonin-delayed phase in these patients as well as difficulties with the excretion pattern     of cortisol. Ghrelin is an orexigenic hormone produced by the stomach which stimulates the     appetite and also has a profound effect on sleep. Our group has demonstrated a substantial     alteration in ghrelin secretion in cirrhosis that correlates with poor slow-wave sleep. In     healthy individuals, ghrelin injection encourages slow-wave sleep while sleep deprivation     increases ghrelin levels. The role of ghrelin in the sleep disturbances of cirrhosis has not     been determined. Prior studies have also lacked the use of overnight polysomnography as a     tool and have relied on either actigraphy or questionnaires. There is a need for detailed     mechanistic and therapeutic approaches to analyzing sleep disturbances in cirrhosis.      Also the therapy of sleep disturbance in cirrhosis is largely empirical. Prior studies have     evaluated hydroxyzine which runs the risk of precipitating HE. Ramelteon is a melatonin     analog that is FDA-approved for use in insomnia and will potentially be useful to restore the     sleep-wake cycle in cirrhosis-associated sleep disturbance.      The investigators aim to study the impact of the FDA-approved ramelteon on the sleep quality     (using questionnaires and sleep diaries) on these patients with cirrhosis.   "
14816|NCT03091530|"     The primary purpose of this study is to determine if the loss of internal rotation following     a throwing session is best restored through soft tissue stretching with the sleeper stretch     or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. This study     will progress the body of research related to internal rotation deficits with regards to     baseball throwers. The research will be relevant to clinicians who treat patients with     baseball players with internal rotation loss.      High school baseball players will be the targeted subjects for this study. They will perform     two exercises (one per week) designed to increase shoulder internal rotation over the course     of three weeks with one week of rest between intervention weeks. The primary outcome will be     shoulder internal rotation range of motion improvements over the course of one week's time.     There are no known adverse risks to either intervention.   "
14890|NCT03090568|"     The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453     under fasted and fed conditions.   "
14801|NCT03091725|"     Bariatric surgery markedly improves glycemic control in persons with T2D. Roux-en-Y gastric     bypass (RYGB) a procedure that bypasses the upper gastrointestinal (UGI) tract results in     greater rates of diabetes resolution compared to methods that leave the UGI tract intact.     Studies suggest that mechanisms beyond weight-loss account for the superiority of RYGB     compared to other surgical methods. These weight-loss independent metabolic effects may     involve increased postprandial production and release of nutrition- responsive hormones.     Fibroblast growth factor 21 (FGF21) is a nutrition-adaptive hormone with the potential to     alleviate symptoms of diabetes and obesity. Preliminary data therefore suggests that RYGB     surgery may alter postprandial FGF21 regulation which could be important for achieving     post-meal nutrient homeostasis. Therefore, the goal of this study is to test how nutrient     content of the meal affects FGF21 concentrations before and after weight loss induced by RYGB     or very low calorie diet (VLCD) therapy. The importance of FGF21 for for glucose, insulin,     triglyceride and adipose tissue and muscle metabolism in these two groups will also be     tested.   "
14802|NCT03091712|"     This is an open label randomized, controlled, parallel intervention study. Group 1 will     receive usual care for insulin degludec titration using the STEP WISE degludec titration     algorithm Group 2 will receive Glooko mobile insulin dosing system, using the STEP WISE     degludec titration algorithm.An estimated n= 240 subjects with type 2 diabetes will be     enrolled in order to obtain approximately 200 evaluable subjects who will complete the 16     week study.   "
14803|NCT03091699|"     Adult smokers will participate in a two stage testing trial, where the first stage will     utilize a within-subject counterbalance design and individuals will participate in both     conditions. The second stage will utilize a two-arm randomized control trail. The two     conditions are (a) moderate intensity exercise and (b) nicotine inhalation. The primary     measure of assessment will be reaction time and accuracy on the N-back task.   "
14804|NCT03091686|"     Societal changes have resulted in reduced demands to be active and increased daily time spent     sitting. Excessive sitting has been shown to be a health hazard. The purpose of this study is     to examine whether sedentary behaviour and diabetes information grounded in The Action     Process Approach is a meaningful source of motivation to reduce daily sitting time among     adult office workers. The intervention will target risk perceptions related to sitting by     presenting research on prolonged sitting and diabetes risk, the effectiveness of breaking up     prolonged sitting, and provide strategies to break up sitting. It is expected that     participants who receive this information will report greater motivation and intentions to     reduce both work and leisure sitting time.   "
14806|NCT03091660|"     This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG)     solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works     compared with TICE BCG solution in treating patients with bladder cancer that has not spread     to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may     stimulate the immune system to fight bladder cancer. Giving different versions of BCG with     vaccine therapy may prevent bladder cancer from returning.   "
14807|NCT03091647|"     This study develops and pilot tests the efficacy of a home-based, self-administered     acupressure intervention in improving cancer-related fatigue (proximal outcome), and physical     functioning and other quality of life outcomes (distal outcomes) of Chinese immigrant breast     cancer survivors (versus usual care control group).   "
14808|NCT03091634|"     This is a multicenter, double-blind, randomized and placebo-controlled trial. The study aims     to evaluate the effectiveness and safety of Xue-Fu-Zhu-Yu Capsule (XFZYC) for Qi Stagnation     and Blood Stasis syndrome (QS&BSS). QS&BSS is one of the common Zhengs in Traditional Chinese     Medicine, which manifests as various symptoms and signs, such as distending pain or tingling     sensation in a fixed position, irritability or depression, dim complexion, lumps in body,     blood spot under the skin, unsmooth or string-like pulse, purplish tongue or petechia in the     tongue, etc. In fact, Qi stagnation and blood stasis are common pathological conditions that     would occur on human body for several times in the long period of human's life. Besides,     QS&BSS is associated with over 50 kinds of diseases including Coronary Heart Disease,     hypertension, cerebral infarction, gastritis, arthritis, dysmenorrhea, chronic pelvic     infection, skin disease, and cancer. Xue-Fu-Zhu-Yu Capsule, one of Chinese herbal medicine     drugs, could perform the function of promoting Qi and activating blood to relieve the     symptoms of QS&BSS, which was approved by the China Food and Drug Administration in 2002. It     has been applied for QS&BSS since it was recorded in the book Correction on Errors in Medical     Classics 200 years ago. In recent years, a number of clinical trials have focused on the     effectiveness and safety of XFZYC on patients with QS&BSS subtype of coronary heart disease,     hyperlipidemia, ischemic cerebrovascular disease, gastritis, dysmenorrhea, and arthritis in     terms of the outcomes of relevant diseases. Our research group plan this randomized     controlled trial to evaluate the effectiveness and safety of Xue-Fu-Zhu-Yu Capsule (XFZYC). A     total of 120 patients will be enrolled at the following three hospitals: (1)Guang'anmen     Hospital, China Academy of Chinese Medical Sciences, (2)Huguosi TCM Hospital Affiliated to     Beijing University of Chinese Medicine, (3)Wangjing Hospital, China Academy of Chinese     Medical Sciences, Beijing, China. All participants, with different kinds of disease, will     receive the standard medical care according to the guidelines. Participants will undergo a     7-week treatment. The primary outcome is the total score of the Traditional Chinese Medicine     Patient Reported Outcome (PRO) Scale in Patients of QS&BSS; the secondary outcome is the     score of the single symptom and sign scale of QS&BSS and the score of the pain scale of     QS&BSS on the day of enrollment, and at 2nd, 4th, 6th, 7th weeks. Safety outcomes include     physical examination (temperature, respiration, heart rate, blood pressure, height and     weight); electrocardiogram (ECG); complete blood cell count; coagulation function     (prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT),     fibrinogen (FIB), D-Dimer, INR); urinalysis; fecal occult blood test; Liver function (ALT,     aspartate aminotransferase (AST), alkaline phosphatase (ALP), serum total bilirubin (STB),     and γ-glutamyl transpeptidase (γ-GT)); renal function (Creatinine (Cr), blood urea nitrogen     (BUN), and urine N-acetyl-β glucosaminidase) on the day of enrollment, and at 7th weeks.   "
14809|NCT03091621|"     To clarify the effectiveness and safety of the direct factor Xa inhibitor rivaroxaban in     domestic clinical use for patients with deep vein thrombosis and pulmonary embolism   "
14810|NCT03091608|"     This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao     Granule (XLGB Granule) through a non-intervention observational way. And attempt to establish     a predictive model to screen susceptibilities to XLGB Granule.   "
14811|NCT03091595|"     A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24     days followed by 4 placebo tablets, is being evaluated for further development. This study     will investigate the effect of this COC on ovarian function inhibition, levels of serum     luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone     during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.   "
14812|NCT03091582|"     The primary objective of the proposed pilot study is to seek to compare the efficacy of two     brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy     (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for     improving depressive symptoms, functioning, and quality of life (QOL). The treatments will     consist of four sessions, which will be delivered during hospitalization.   "
14813|NCT03091569|"     The primary objective of the study is to investigate whether topical Vitamin K application     reduces the grade of erythema in comparison with a vehicle cream (placebo) through     physicians' assessment and participant self-assessment.      The secondary objectives of this study are to evaluate in this study population: effects of     Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing     the erythema diameter; and the evaluation of participants' satisfaction related to the     injection treatment.   "
14814|NCT03091556|"     This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao     Pill (XLGB Pill) through a non-intervention observational way. And attempt to establish a     predictive model to screen susceptibilities to XLGB Pill.   "
14815|NCT03091543|"     To investigate the effect of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and     200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of     controlled release levodopa/benserazide 100/25 mg and to assess the tolerability and safety     of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) when administered in     combination with a single-dose of controlled release levodopa/benserazide 100/25 mg.   "
14817|NCT03091517|"     This single arm pilot study will explore the feasibility of GlycoLeap, a proprietary online     lifestyle modification and self-management education program developed in Singapore for     people with type 2 diabetes, as an add-on to primary care delivered through one of the     SingHealth Polyclinics.   "
15918|NCT03077126|"     The main purpose of this study is to determine the accuracy and feasibility (possibility) of     Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.)     for detecting prostate cancer in men undergoing radical prostatectomy.   "
14818|NCT03091504|"     High-humidity nasal cannula (HFNC) has been shown to be effective in improving oxygenation     and avoiding intubation in multiple randomized control trials, it is also suitable and     feasible for long term use. Aerosol delivery via HFNC will minimize interruptions and improve     patient compliance, bench study and radionuclide imaging study done in healthy volunteers     demonstrated that aerosol can be effectively delivered using HFNC. This study aims to     evaluate the efficacy of bronchodilator delivered via HFNC in chronic pulmonary obstructive     disease or asthma patients.   "
14819|NCT03091491|"     The purpose of this study is to determine whether Nivolumab in combination with Ipilimumab is     associated with superior response rate compared to Nivolumab alone in patients with advanced     Epidermal Growth Factor Receptor (EGFR) mutation positive Non-small Cell Lung Cancer who have     failed one line of standard EGFR tyrosine kinase inhibitor and not more than one line of     chemotherapy regimen. This study also aims to determine predictive biomarkers of     response/benefit in patients with EGFR mutation positive NSCLC.   "
14820|NCT03091478|"     This is an open-label phase II study of pembrolizumab in patients with advanced solid tumors     with leptomeningeal carcinomatosis (LMD). Patients may have received any number of prior     therapies for their respective solid tumors, but must not have received prior anti-PD-1     therapy and developed progressive disease. Approximately 18 subjects in this study will     receive pembrolizumab at a dose of 200mg intravenously (IV) every 3 weeks (Q3W) for 4 doses.     In patients who derive clinical benefit from therapy, pembrolizumab may be continued until     documented disease progression, unacceptable adverse event(s), intercurrent illness that     prevents further administration of treatment, investigator's decision to withdraw the     subject, subject withdrawal of consent, noncompliance with trial treatment or procedure     requirements, or for administrative reasons.   "
22912|NCT02985697|"     The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine     when used in combination with oral midazolam and/or nitrous oxide for moderate sedation     during pediatric outpatient dental procedures.   "
14821|NCT03091465|"     This is a nation-wide retrospective observational study which will be performed in 50 centres     in Spain, geographically representative of all regions, with at least 5 patients treated with     first-line pazopanib for mRCC in daily clinical practice since April 2011 (date of approval     of pazopanib in Spain), January 2016.      Pazopanib is one of the standard tyrosine-kinase inhibitors (TKI) for the first-line     treatment of metastatic renal cell carcinoma. In our previous SPAZO study, the Spanish     Oncologic Genitourinary Group (SOGUG) validated the IMDC prognostic classification for     patients receiving first-line pazopanib, and demonstrated the effectiveness of this drug in     routine clinical practice. However, in this series of 278 patients, we could not obtain     enough information on the effectiveness of pazopanib in special subpopulations such as     non-clear cell histologies, and others subgroups, due to a small simple size of each of these     subpopulations. On the other hand, after the results of RECORD-1 and AXIS trials, switching     to everolimus or axitinib is the current approach for patients who progresses to a first-line     TKI. However, these pivotal studies did not include patients treated with first-line     pazopanib study because this drug was not available at that time. The results of the SPAZO     study also suggested that the effectiveness of second-line targeted therapies (TT) after     pazopanib in routine clinical practice is similar to the observed in clinical trials after     sunitinib, sorafenib or bevacizumab. In addition, the preliminary results indicated that     there are not meaningful differences in the effectiveness of TKI or mTOR inhibitors after     pazopanib, when the results are adjusted by the IMDC prognostic classification. However, the     IMDC prognostic classification for second-line TT has not yet been validated for patients who     receive pazopanib as first-line. In addition our sample size was not large enough to make a     comparison of effectiveness between mTOR inhibitors and antiVEGF for each prognostic     subgroups of the IMDC.      Based on that, the Spanish Oncologic Genitourinary Group has decided to launch the SPAZO-2     study, in which we intend to prolong the follow up of patients included in SPAZO, and to     increase the sample size with new patients from new centres, in order to obtain a larger     sample in each of the subpopulations of interest, with the objective of obtaining more     information about the above questions.   "
14822|NCT03091452|"     CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation     is treated by cardiac surgical ablation.   "
14823|NCT03091439|"     This clinical study will be a multi-center, randomized, open-label, active-controlled,     parallel-group study comparing dalbavancin to standard of care (SOC) therapy in     osteomyelitis.   "
14824|NCT03091426|"     This study has a randomized, double-blind, placebo-controlled design to assess the efficacy,     pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic     dermatitis when applied BID to all atopic dermatitis lesions.   "
14825|NCT03091413|"     This study evaluates the correlation between maximum inspiratory pressure (Pi max) and the     diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from     invasive mechanical ventilation.   "
14826|NCT03091400|"     The purpose of this crossover trial is to investigate whether atomoxetine (versus placebo)     improves memory function in persons with memory deficits due to multiple sclerosis.   "
14827|NCT03091387|"     Intubation and ventilation are lifesaving interventions in the neonatal intensive care unit     (ICU), especially among preterm, low birth weight babies. However, timely extubation is also     necessary. The decision to extubate usually depends on clinical judgement, appropriate blood     gas prior to extubation and low ventilator parameters. Approximately 40 % of babies'     extubated on the above criteria require re-intubation, suggesting that current methods to     predict extubation failure are insufficient. . Spontaneous breathing trial (SBT) has been     predominantly used in infants and children to access the readiness for extubation. Few     studies in premature neonates have also shown good sensitivity and specificity in predicting     extubation success. However its significance in our population is yet to be determined. We     aim to use this for both our preterm and term babies and if results are significant we plan     to include this as our routine pre extubation criteria.   "
14837|NCT03091257|"     This research study is studying a targeted therapy as a possible treatment for multiple     myeloma.      The names of the study drugs involved in this study are:        -  Trametinib        -  Dabrafenib   "
14838|NCT03091244|"     This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao     Capsule (XLGB Capsule) through a non-intervention observational way. And attempt to establish     a predictive model to screen susceptibilities to XLGB Capsule.   "
14839|NCT03091231|"     The primary objective of the study is the matching of sensitivity, specificity, the negative     predicate value and the positive predictive value of Contrast-Enhanced Ultrasound (CEUS),     Shear Wave Elastography (SWE) and the combination to detect clinically significant prostate     carcinoma foki.      Conventional ultrasound is insufficient to safely display prostate carcinoma. Therefore,     other imaging agents are recently added to improve the detection of tumor foci. These include     innovative imaging ultrasound methods and multiparametric MRI.   "
14840|NCT03091218|"     This is a prospective registry study to surveil early liver injuries caused by Runzao Zhiyang     Capsule (RZZY Capsule) through a non-intervention observational way. And attempt to establish     a predictive model to screen susceptibilities to RZZY Capsule.   "
14828|NCT03091374|"     Antiretroviral therapy (ART) has improved the health of more than 18 million people infected     with HIV by controlling viral replication, AIDS and non-AIDS events, and by reducing the risk     of transmission. However, the existence of latent viral reservoirs in long-lived memory CD4 T     cells remains a hurdle to curing HIV infection; consequently patients must remain on ART for     the rest of their lives. Recently, a more realistic approach under limelight is to identify     strategies leading to a functional cure, which is defined as the natural control of viral     reservoir by the host. Use of recombinant human growth hormone has been shown to improve     immune function by several mechanisms. This study hypothesizes that treatment with     recombinant human growth hormone will decrease the size of the replication competent HIV     reservoir in HIV-infected immune-reconstituted individuals.      The specific study objectives include:        -  To evaluate the effect of recombinant human growth hormone administration for 48 weeks          on the size of the replication competent HIV reservoir        -  To evaluate the safety and tolerability of recombinant human growth hormone          administration for 48 weeks in HIV-infected individuals on suppressive ART.      For this purpose, the investigators will add recombinant human growth hormone treatment for     the patients receiving stable ART. Approximately 22 participants will be enrolled in this     study at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal,     Canada), which will last about 52 weeks. Participants will be treated with recombinant human     growth hormone for a total of 48 weeks. The initial recombinant human growth hormone dose     will be 3 mg/day (30-40 µg/kg/d) for 24 weeks administered by subcutaneous injection on an     outpatient basis, followed by dose reduction to 1.5 mg/day for the final 24 weeks of the     treatment period, also conducted on an outpatient basis. The study inclusion criteria include     male and female participants, ≥18 and <40 years of age, with an undetectable viral load (the     quantity of the HIV virus in the blood must be less than 50 copies/ml) during last 24 months     and with a CD4 T-cell count ≥350 cells/mm3 obtained within 30 days prior to study entry. The     findings from this study will contribute to the development of novel strategies to eradicate     HIV.   "
14829|NCT03091361|"     This is a non-randomized, single-blind post market clinical follow-up study for which 50     patients will be imaged at the Judy Dan Research and Treatment Centre who present with a     chronic and are receiving standard wound care treatment. The i:X imaging device visualizes     fluorescing bacteria in real-time. The device will be used as an adjunctive tool in the     assessment of the wound and will be used to guide the targeted sampling of a wound (with     curettage scraping). The overall objective of this work is to evaluate the positive     predictive value (PPV) of the MolecuLight i:X Imaging Device in predicting the presence of     bacteria in chronic wounds. The presence of bacteria will be determined micro-biologically by     semi-quantitative culture analysis.   "
14830|NCT03091348|"     In this randomized, cross‐over study 20 subjects who are undergoing testosterone (T) therapy     for the treatment of T deficiency will receive both subcutaneous testosterone therapy and     intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM     injection and one group will receive an IM injection followed by a SQ injection. The primary     objective of this study is to measure testosterone concentration in men after these two     treatment routes and determine if there are any significant differences due to modes of     administration. Endpoints will include total serum testosterone and calculated free     testosterone. A questionnaire will also be administered to assess overall patient experience     with each route of administration.   "
14831|NCT03091335|"     This study aims to demonstrate that music listening in patients undergoing awake deep brain     stimulation reduces subjective and objective measures of anxiety. Furthermore, the     investigators aim to demonstrate that music may alter neuronal firing patterns based on the     type of music played and the location in the brain.   "
16466|NCT03069950|"     The purpose of this study is to see if patients treated with both regional chemotherapy using     the HAI pump and intravenous chemotherapy are able to have their liver tumors removed     surgically (resected), versus treatment with only intravenous chemotherapy.   "
14832|NCT03091322|"     This study is designed as post market clinical follow-up study with CE-marked products to     evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under     clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks     associated with the use of the BIOTRONIK Edora family pacemakers. The study is further     designed to address potential regulatory needs of clinical data for countries and regions not     covered by the CE approval.   "
14833|NCT03091309|"     Inflammatory Bowel Disease (IBD) is a chronic inflammatory disorder of the gastrointestinal     tract that comprises two subtypes, Crohn's disease (CD) and Ulcerative Colitis (UC). Because     the risk of IBD is greatest during the third decade of life, its impact for women is during     the reproductive years. Women with inflammatory bowel disease are at a 2-fold higher risk of     adverse outcomes during pregnancy as compared to the general population. Pregnancy is an     especially vulnerable time for women with IBD, and out of misguided concerns that medications     may confer unnecessary harms to their fetus, many women often stop taking life savings     medications; without realizing that this sub-optimal adherence could actually lead to life     threatening complications for them and their fetus. Counseling pregnant women with IBD is     therefore an important step in improving medication adherence. The investigators hypothesize     that counseling sessions with an IBD nurse that incorporates motivational interviewing and     telemedicine-based follow-up sessions tailored to individual needs will improve medication     adherence and pregnancy outcomes.      The following specific aims are to be addressed by this multi-center randomized clinical     trial comparing individual nurse-based counseling to standard of care:      Specific Aim #1: To assess whether patient-centered counseling incorporating motivational     interviewing and telemedicine-based follow-up by an IBD nurse leads to improved medication     adherence during pregnancy and pregnancy outcomes      Specific Aim #2: To validate the use of self-reported medication adherence during pregnancy     in the IBD population   "
14834|NCT03091296|"     In this case‐controlled, observational study, 24 subjects will participate in a 12‐hour blood     collection with a single blood draw at +24 hours. 12 men will have low testosterone levels     (hypogonadism) and 12 men will have normal testosterone levels. Blood samples will be drawn     every 2 hours and later analyzed for total testosterone and calculated free testosterone. The     primary objective of this study is to assess the degree of diurnal variation in men with     testosterone deficiency.   "
14835|NCT03091283|"     Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia,     has to work laboriously to cope with all assigned activities day and night. Time management,     therefore, becomes a practical tool for nurse student to reach her goal. However, many     factors act as barriers to nurse students' attaining and maintaining a high grade point     average (GPA). Investigators would like to determine the effect of skills in time management     on GPA amongst faculty nursing students.   "
14836|NCT03091270|"     This study was designed to collect a series of patients with gliomas which were involved in     motor cortex to analyze difference accuracy of motor cortex localization between BOLD-fMRI     and ZOOMit-fMRI.   "
14842|NCT03091192|"     This study is designed for patients diagnosed with MET-driven, unresectable and locally     advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if     an investigational new anti-cancer medication, savolitinib, is effective in treating patients     with MET-driven PRCC, how it compares with another medication frequently used to treat this     disease called sunitinib, and what side effects it might cause.   "
14843|NCT03091179|"     The purpose of this study is to investigate whether selected, short laryngologic surgical     procedures can be safely and potentially more effectively performed without the use of     endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas     exchange will be supported by rapid insufflation of high-flow oxygen through specialized     nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange     (THRIVE).   "
14844|NCT03091166|"     Investigation of effect of perioperative Dexmedetomedine administration on mortality, length     of ICU stay, delirium onset, heart failure, acute kidney injury, SIRS in cardiac surgery     patients.   "
14854|NCT03091036|"     The aim of this study is to assess the effectiveness of proactive and integrated healthcare     program for chronic complex patients (CCP). This program are based in coordination the     primary level of attention with and speciality level. The objective is reducing hospital     readmissions and know the benefit in total cost of care in 4 month before and 4 after     intervention.   "
14863|NCT03090919|"     Sepsis is life-threatening and dysregulated response to infection that results in endothelial     activation and dysfunction that leads to systemic microvascular leak and multiple-organ     failure. This study will identify patients that have sepsis with thrombocytopenia and     randomize them to receive a unit of platelets or an equivalent volume of saline.   "
14845|NCT03091153|"     This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long     Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of     the clinical pharmacy services provided in the LTC facility. For this study, eligible     residents will be randomized to receive either a deprescribing focused medication review or     usual care.      The deprescribing focused medication therapy assessments will be done on 33 the 66 patients     residing on the second floor of the home. The other half of residents will serve as the     control group and continue to receive their annual medication review and regular care from     the attending physicians and nurses.      The deprescribing intervention will be delivered by final year pharmacy students completing     their practice experiences, under the supervision of clinical pharmacists at the LTC facility     and clinical pharmacists from Memorial University's Medication Therapy Services (MTS) Clinic.     Currently the clinic has a well developed procedure for providing in depth medication therapy     reviews for residents of the community, upon referral by their primary care physician.     Students will adapt this model of medication review to have a stronger deprescribing focus     and be applicable to elderly residents of a LTC facility. The intervention will consist of an     in depth medication therapy review with a focus on identifying any medications that may no     longer be required or are deemed to be inappropriate or potentially unsafe in the elderly     based on currently guidelines/criteria. The students will work closely with members of the     resident's care team on a daily basis, as well as the resident and their family, to develop     and implement a deprescribing plan.   "
14846|NCT03091140|"     Protocol title: Alterations in functional characteristics of the muscle tissue following     surgery for primary hyperparathyroidism.      Purpose: To detect any changes in functional characteristics of muscles in patients who     undergo surgery for primary hyperparathyroidism compared to patients with primary     hyperparathyroidism and conservative treatment, patients undergoing thyroid surgery and     healthy subjects.      Design: Prospective, multi-center observational study Patient Population: Male or female     subjects 18 years of age or older scheduled for parathyroidectomy No. of Subjects: 50     patients undergoing parathyroidectomy, 50 patients undergoing conservative follow up, 50     patients undergoing thyroid surgery due to nontoxic multinodular goiter or solitary nontoxic     thyroid adenoma and 50 healthy control subjects, estimated up to 12 months to enroll.      Duration of Treatment: During the operation Duration of Follow-up: Follow-up will be     performed daily during hospitalization and at 3, 6 and 12 months after the procedure     Endpoints: To evaluate the changes in functional characteristics of all the type of muscles     which occur after parathyroidectomy for primary hyperparathyroidism.   "
14848|NCT03091114|"     Background:      A predictive factor is a measure that predicts treatment response. Decisions on internal     fixations of lower limb fractures should regard predictive factors to personalize (e.g. age)     treatment. However for most potentially influencing factors valid data on the predictive     value is sparse.      Objectives:      The objective of this study is to identify predictive factors and quantify their predictive     ability for treatment failure in patients with limb fractures treated with osteosynthesis.      Methods:      Patients Adult patients (≥18 year) with isolated fractures scheduled for urgent or     semi-urgent surgery using internal fixations because of lower limb fractures.      The predictive value of the following exposures will be analyzed:        -  Age        -  Gender        -  Diabetes        -  Smoking status        -  Body Mass Index        -  Open fractures        -  Peripheral arterial disease      Outcome The outcome will be (time to) reoperation of the same fracture because of failure of     internal fixation due to nonunion or implant failure.      Study design A prospective observational cohort study will be performed. Sample size 300     patients will be included.      Statistical analysis:      For the main analysis a multivariate stratified Cox proportional hazard model will be used.     The Model will be stratified according to the indication. In the Cox proportional hazard     model all predictive factors will be entered simultaneously to quantify the independent     influence (adjusted for all other factors) of each factor. The strength of prediction will be     described with hazard rations and their corresponding 95% confidence intervals.   "
14849|NCT03091101|"     The purpose of this study is to investigate changes in corneal innervation during scleral     contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity     and nerve fiber density from baseline in the central and mid-peripheral corneal locations     will be measured over a 6-month lens wear period. An additional aim of the study is to     investigate the impact of scleral lens wear on corneal inflammation within the same study     group. This will be achieved by comparing dendritic cell density change from baseline over     the study period.   "
14850|NCT03091088|"     According to the World Health Organization criteria, osteoporosis was defined as a bone     mineral density that lies 2.5 standard deviations or more below the average value for young     healthy women. Osteoporosis is a major cause of fractures and can lead to serious     complications in postmenopausal women. For this reason, approaches to prevent the appearance     and progression of osteoporosis are of primary importance. This randomized clinical trial     analyzes the effects of two types of physical exercise oriented to prevent osteoporosis in     postmenopausal women with pharmacological supplements of Calcium and Vitamin-D.   "
14851|NCT03091075|"     This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a     biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone     (the principal male sex hormone and an anabolic steroid), given for 12 weeks following     rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.   "
14852|NCT03091062|"     The aim of this study is to assess the effectiveness of an Airway Clearance System.   "
14853|NCT03091049|"     An open label observational clinical study to compare the efficacy of EMLA cream (lidocaine     2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local     anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate     peri-operative local anesthesia during transradial coronary angiography   "
14855|NCT03091023|"     This project aims to study the endometrial transcriptome at the single cell level in both     endometrial native tissue (biopsies) and endometrial fluid. Basically, the goals are: 1) To     use the resolution provided by single-cell RNA-seq to deconvolute real time dynamics in     endometrium transcriptome throughout the menstrual cycle from artifacts produced by known     population heterogeneity, and 2) To use endometrium fluid to replace endometrium biopsies as     signal source to develop a new diagnostic platform to determine the endometrium receptive     state which is high resolution and minimally invasive. This study will provide an     unprecedented high-resolution characterization of the endometrium cellular hierarchy via     whole transcriptome analysis throughout the menstrual stages. These results will lead to a     robust definition of stage-defining gene expression signatures and resolve the long-standing     inconsistencies originating from bulk tissue studies. The dataset will be further explored     via informatics tools to provide biological insights into the dynamics of endometrium and     initiate new anchor points for functional studies.   "
14856|NCT03091010|"     Study population: Patients attending the Out Patient Department and admitted to Institute of     Liver and Biliary Sciences.      Study design: Prospective randomized controlled trial Study period: One year- January 2017-     December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be     given Fecal Microbiota Transplantation through a NJ tube placed after admission to the     hospital. Participants will be administered the processed fecal microbiota sample collected     from a related or unrelated healthy donor for a period of 7 days.      Monitoring and assessment:      The recipient will be monitored every day after Fecal Microbiota Transplantation therapy.      The recipient will undergo physical examination, complete blood counts, at baseline and a     chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function     Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day     0,4,7,14,28,90,180,270 and 365 from the start of therapy.      Microbiota analysis of the donors will be done at baseline and the recipients will be done on     day 0,7,28,90 & 180.   "
14858|NCT03090984|"     Every patient included in the study will undergo 3 standardised hemodialysis treatments, each     using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will     be randomized.      During each conventional and standardised hemodialysis treatment, 6 blood samples will be     taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation     activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase     pathway of coagulation (kallikrein, fXIa, fXIIa).   "
14859|NCT03090971|"     This is an open, controlled, prospective, proof-of-concept study, in 7 patients presenting     NF1 and cutaneous neurofibromas. This study will include three treatment visits to the study     center and three follow-up visits. Treatment will consist of two stages: neurofibroma     microporation using the laser device, followed by topical application of one drop of     diclofenac 25mg/ml on the surface of the neurofibroma; followed by re-application of one drop     of diclofenac, twice daily, for three days. The applications subsequent to the first     application will be performed by the patients. Subjects will return to the study center at     three day intervals (Assessments 2 & 3) for new microporation and topical diclofenac     application, followed by at-home topical diclofenac application for three more days.     Assessment 4 will take place 3 days after Assessment 3. Assessment 5 will take place 7 days     after the end of the treatment period and Assessment 6 at 30 days after the last application     of study drug. The primary efficacy variable in this study is the inflammatory process with     the presence of tissue necrosis. The primary safety variable is the occurrence of adverse     events considered to be associated with the study drug, occurring during the treatment     period.   "
14860|NCT03090958|"     AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile     phones to improve linkage and engagement in care among newly diagnosed HIV+ young men who     have sex with men (YMSM). The features of the intervention aim to target previously     identified barriers to care among newly diagnosed youth, namely, low HIV health literacy,     lack of social support, and internalized stigma related to their diagnosis. AllyQuest will be     an interactive mobile phone intervention for HIV+ YMSM that utilizes social networking,     game-based mechanics and a story-based framework to guide behavior change. Grounded in Social     Cognitive Theory, narrative communication and the principles of persuasive technology, the     intervention is designed to capitalize on social involvement as a means through which HIV+     YMSM can receive information and social support, experience social norms and reflective     appraisals, and feel a sense of connectedness to peers.   "
14891|NCT03090555|"     This study evaluates the addition of translational manipulation under interscalene block, to     a course of orthopaedic manual physical therapy for treatment of adhesive capsulitis of the     shoulder. Half the patients will receive a translational manipulation under interscalene     block, plus 6 sessions of orthopaedic manual physical therapy. The other half will receive 7     sessions of physical therapy. The investigators hypothesize that the translational     manipulation under interscalene block will provide additional benefit beyond the effect of     in-clinic orthopaedic manual physical therapy alone.   "
14861|NCT03090945|"     The goal of this study is to identify significant clinical and laboratory risk factors in     pediatric patients with significant upper gastrointestinal bleeding. This is defined as     bleeding that necessitates an upper endoscopic evaluation to either diagnose or treat upper     GI bleeding during their hospital admission. If a predictive/risk stratification relationship     exists, these data could permit a more effective triaging and intervention scheme in     pediatric patients presenting with complaints of gastrointestinal bleeding. In addition we     want to get a better understanding of the re-bleeding rate after endoscopic therapy for upper     GI bleeding and if there are any identifiable risk factors for re-bleeding. Lastly we want to     understand best practice management for upper GI bleeding.   "
14862|NCT03090932|"     Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disorder characterized     by progressive muscle weakness and eventual death. Studies demonstrate that the immune system     plays a key role in ALS progression; however, the role of the immune system is unclear, as     various aspects can play both a beneficial and detrimental role in the disease course.     Attempts to universally suppress the immune system in ALS patients have at best had     negligible effects on progression or at worst accelerated the disease. Thus, there is a     critical need to identify immune cell populations to serve as biomarkers and therapeutic     targets.   "
16467|NCT03069937|"     The purpose of this study is to look at patient outcomes when docetaxel is started prior to     ADT with degarelix.   "
14865|NCT03090893|"     The objective of this study will be to prospectively evaluate the response of a continuous     infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and     maintain the AT activity within a specified range in adult patients that require     extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac     surgery.   "
14866|NCT03090880|"     Prospective randomized open multicenter trial with blinded adjudication of endpoints to     assess the efficacy of six-month low-dose LMWH for the prevention of symptomatic or     incidental VTE in patients with stage IV lung cancer and elevated D-dimer.   "
14867|NCT03090867|"     ICUs have always perceived by the public has a very technical unit with a restricted and/or     forbidden access. Physical alteration of the patient, seeing the patient sedated, the large     numbers of devices, the alarms and an uncertain prognosis. All this factors can be perceived     by people close to the patient as a source of stress. In the literature, numerous studies     have shown that families develop anxiety and depression symptoms while their loved one is     hospitalized in the ICU. French intensive care societies thought of ways to prevent or     diminish these symptoms. The 6th consensus conference on  Live better in the ICU      recommends: effective and adapted information, large visiting hours to reach an unrestricted     access and family participation in care.      The unit has taken this path to improve patient and family centered care by: creating a     welcome leaflet, a room dedicated to meetings with families and an ICU open 24/7bto families,     with the possibility for children to visit their parents. Hence, spontaneously, relatives     have expressed the wish to participate to certain care and when participating, expressed     their satisfaction. This observation and testimonies from family members and patients led us     to think about the impact of participation of care. Two major French studies have shown     contradictory outcomes: 16% of families would have been willing to participate in the first     study against 97% in the second one. These studies were survey done after the ICU discharge.      No study today has assessed the actual impact of family participation in care. The aim of     this clinical trial is to diminish anxiety and depression symptoms. By participating in care,     relatives can develop or strengthen a relationship of trust with caregivers. It could     contribute also to a better understanding of the plan of care and an easier context to     announce negative outcomes.   "
14868|NCT03090854|"     Several previous studies have assessed acetylcholine (Ach) and acetylcholinesterase activity     (AchE-a) levels in Alzheimer's disease (AD) pathophysiology. The cerebrospinal fluid (CSF)     Ach level was significantly decreased in AD patients, and correlated positively with dementia     score and MMSE (1, 2). Two studies have demonstrated positive correlations between CSF AchE-a     and CSF Tau, phosphorylated-Tau (P-Tau) and AB 1-42 peptide (3,4). ChEIs (cholinesterase     inhibitors) have been approved for the treatment of AD but only 20 to 30 % of patients are     responders (5). Any consistent data allow the clinician to predict the response to the     treatment. The link between basal cholinergic status and ChEIs efficiency has never been     done. Even if, there is a wild research in AD treatment, ChEIs or treatment acting on the Ach     pathways will remain a long time valuable treatment particularly in moderate AD in which     disease modifying therapies did not show any efficiency.      The investigators's objective is to prospectively explore the predicting value of CSF Ach and     AchE-a levels on ChEIs response in AD patients.   "
14869|NCT03090841|"     The purposes of this study are to determine 1) if the diagnosis of CMV fetal infection could     be done directly in the maternal blood instead of requesting an amniocentesis and 2) if     innovative technologies such as proteomic, transcriptomic, methylomic and lipidomic applied     in fetal samples could allow the discovery of new biomarkers of fetal infection.   "
14870|NCT03090828|"     1600 patients with severe, end stage renal disease or post transplant will be randomised     1:1:1 to either standard therapeutic education; or education using a specific app; or the     enhanced interactive app using feedback messages.      The total follow up duration is 18 months. Primary endpoint is the cost utility of using     app-based therapeutic intervention, secondary endpoints are: compliance with treatment     guidelines, app use (professionals and patients), budget impact analysis   "
14871|NCT03090815|"     Lung cancer is the leading cause of cancer death in the U.S. and throughout the world. Lung     cancers are broadly divided histologically into small cell lung cancer (SCLC) and non-small     cell lung cancer (NSCLC). About 25% of patients with NSCLC have stage I or II disease. The     primary treatment modality is surgical resection,2 and 5-year survival rates are 65% for     stage I and 41% for stage II disease. However, more than 70% of patients with NSCLC present     with stage III or IV disease. Patients with stage III disease are most commonly treated with     chemoradiation, and 5-year survival rate is 26%. Chemotherapy and targeted therapy are often     used for stage IV disease, which has a 5-year survival rate of 4%.      Tyrosine kinase inhibitor (TKI) is a targeted therapy against specific molecules in critical     cell-signaling pathways involved in lung carcinogenesis. The currently available FDA approved     TKIs for advanced NSCLC include afatinib, gefitinib, and erlotinib that inhibit epidermal     growth factor receptor (EGFR) signaling 6 and crizotinib that inhibits anaplastic lymphoma     kinase (ALK) signaling. However, only tumors that carry the corresponding oncogenic mutations     (e.g., sensitizing EGFR mutations) would respond well to these TKIs. Meta-analyses of     clinical trials evaluating the efficacy of gefitinib and erlotinib have demonstrated that     NSCLC patients who are EGFR mutation-positive have a lower risk of disease progression when     treated with an EGFR-TKI as compared to those treated with chemotherapy (HR = 0.43, 95%     confidence interval, CI=0.38-0.49). EGFR-TKI, however, confers no benefits to patients who     are EGFR wildtype (HR = 1.06, 95% CI=0.94-1.19). A phase III trial of crizotinib has also     demonstrated the superiority of crizotinib to standard chemotherapy in ALK-positive NSCLC     patients (HR = 0.49; 95% CI=0.37-0.64).      In Hong Kong, as in other parts of Asia like in China and in Taiwan, other than the majority     of lung cancer patients being smokers, there is also a prominence of non-smokers in lung     cancer. Compared with Caucasians, there is also a relatively higher incidence of EGFR     mutation in lung adenocarcinomas. The prevalence of EGFR mutation in Asian population with     lung adenocarcinomas can reach up to 60% compared to at most 30% in the Caucasian population.     These EGFR mutant tumors will demonstrate better response to the drug EGFR-TKI, boosting up     the response rate to almost 70% compared to 30% with conventional chemotherapy for lung     cancer. Even with this remarkable response, however, EGFR-TKI will eventually fail in EGFR     mutant lung cancer. There is an imminent need to look for newer therapeutic targets or agents     that can overcome this acquired resistance to anti-cancer drugs and to explore alternative     molecular signaling pathways that could interact or enhance EGFR signaling pathways to     modulate the therapeutic response in lung cancer.   "
14872|NCT03090802|"     This study aims to evaluate the efficacy of an intervention designed to reduce STI/HIV     incidence by increasing the number of adolescent mothers who re-enroll and remain in school.     The objective of the intervention is to have older mentor mothers, who themselves were     pregnant adolescents, to mentor younger adolescent mothers. Mentor mothers will provide     ongoing psychosocial support, help navigate re-admission to school, and help facilitate     access to an existing State-sponsored cash transfer, the child support grant (CSG), in the     early postpartum period. Our combination social protection program will enhance resilience of     young adolescent mothers to facilitate their return to school and thereby reduce HIV risk.     The investigators will evaluate the efficacy of the intervention using a pre-test post-test     randomized controlled trial design. Participants in the intervention will receive the     Mentoring Adolescent Mothers At School (MAMAS) intervention and standard postpartum care.     Those in the control arm will receive standard postpartum care. Additionally, for those     participants randomized to the intervention arm, mentor mothers will use participatory visual     methods (e.g., photovoice, cell-films, drawings) as part of the intervention itself. Last,     among those participants randomized to the intervention arm and who return for their 9-month     assessment, the investigators will conduct 20 in-depth interviews to understand the process     of resilience development from their perspective.      Primary outcomes:      School outcomes (initial outcomes) HYP 1.1: Program participation will increase school     enrollment HYP 1.2: Program participation will increase school engagement      HIV risk outcomes (intermediate outcomes) HYP 2.1: Program participation will reduce number     of sexual partners HYP 2.2: Program participation will reduce inconsistent condom use HYP     2.3: Program participation will reduce intimate partner violence HYP 2.4: Program     participation will decrease HIV/STI infection HYP 2.5 (for HIV+): Program participation will     increase retention in care      Secondary outcomes:      HYP 5: Program participation will increase peer support HYP 6: Program participation will     increase familial support HYP 7: Program participation will increase school re-admission HYP     8: Program participation will increase application to the child support grant HYP 9: Program     participation will increase receipt of the child support grant   "
14905|NCT03090373|"     This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on     preventing bacterial colonization in longterm indwelling catheters. The duration of the trial     is 30 days. The investigator will be quantifying the number of bacterial colonies in the     urinary catheter and in the bladder in both the treatment and control group.   "
14873|NCT03090789|"     This multicenter natural history study aims to expand the network of clinical research     centers in FA, and to provide a framework for facilitating therapeutic interventions. In     addition, this study will lead to the development of valid yet sensitive clinical measures     crucial to outcome assessment of patients with Friedreich's Ataxia. This study will support     genetic modifier studies, biomarker studies, and frataxin protein level assessments by     building a sample repository.   "
14874|NCT03090776|"     Aim 1: To determine the effectiveness of perioperatively administered ketamine to decrease     acute and persistent postmastectomy pain (PPMP).      Hypothesis 1.1: Patients undergoing partial or total mastectomy treated with a bolus and     perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased     postoperative pain and opioid utilization compared to those receiving saline control.      Hypothesis 1.2: Patients undergoing partial or total mastectomy treated with a bolus and     perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased     persistent postoperative pain measured at one year after surgery.      Aim 2: To determine whether there is increased power to detect therapeutic effectiveness in     an interventional preventive trial, by enrichment with patients at high risk of PPMP.      Hypothesis 2.1: Ketamine will have a greater analgesic and opioid sparing effect on pain     scores in high-risk patients than non-high risk patients, compared to placebo.      Hypothesis 2.2: Ketamine will have a greater preventive effect on pain burden scores at one     year after surgery in high-risk patients than non-high risk patients, compared to placebo.   "
14875|NCT03090763|"     The objective of this study is to establish whether patients with aortic aneurysm, compared     to general population, have higher levels of selected miRNAs and whether there is significant     association between the level of miRNA in circulating blood and the size of the aortic     aneurysm or the risk of its rupture.   "
14876|NCT03090750|"     The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower     anxiety in patients having invasive Radiology procedures. First, the level of anxiety is     assessed prior to the procedure using a questionnaire. Then, patients are given the     aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to     determine how anxious the patient is after the aromatherapy and before going into the     procedure room. After the procedure, patients are asked to evaluate the process of the study.   "
14877|NCT03090737|"     A study to evaluate the safety of Nivolumab in patients with advanced or metastatic non-small     cell lung cancer   "
14878|NCT03090724|"     The purpose of this study was to assess the effects of age on the pharmacokinetic (PK)     profile of BIA 5-453 and its metabolites.   "
14879|NCT03090711|"     Brain functions are supported by multiple cell types, including neuronal and non-neuronal     cells that are connected into complex networks. When the connectivity between those cells is     altered or disrupted, the functioning of the brain is impaired. In stroke, the interruption     of blood supply to the neural circuits results in connectivity damage and permanent     disabilities. Experimental evidence suggests that some types of brain state, including sleep,     can protect brain tissue from stroke and repair the damaged circuits. This project will     investigate the neuronal mechanism underlying the protective effect of sleep on brain     connectivity and network activity. To this end, the investigators will use a collection of     state-of-the-art technologies including high-density electroencephalography (hd-EEG),     transcranial magnetic stimulation (TMS) and transcranial alternating current stimulation     (tACS). Perspectives include a better understanding of the causes and consequences of the     perturbed electrical activity of the brain during sleep in stroke patients.   "
14880|NCT03090698|"     A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both     associated in patients with severe osteoarthritis of the knee with follow up of one, three     and six months.   "
14881|NCT03090685|"     Chikungunya fever is an acute viral disease, transmitted by the mosquito (Aedes aegypti),     that triggers pain and disabling rheumatic manifestations. There is no cure for this disease,     and the usual treatment is directed at relieving symptoms through the use of analgesics and     antipyretics. Due to the risk of adverse effects triggered by prolonged use of analgesic and     anti-inflammatory drugs, the use of complementary therapies, such as Auriculotherapy, might     be a safe and effective non-pharmacological treatment for the management of Chikungunya     symptomatic cases.      Subjects diagnosed with Chikungunya and undergoing routine treatment will receive     auricotherapy treatment once a week, for five weeks. Subjects will be assessed at baseline     and after 4 and 8 weeks after intervention. This study might help understand the use of     Auriculotherapy as a complementary treatment in the treatment of physical and functional     symptoms of individuals infected by Chikungunya .   "
14892|NCT03090542|"     In healthy subjects not receiving or requiring lipid lowering therapy and who do not have     diabetes, the use of clinoptilolite (GPUR) will result in a reduction of absorbed dietary     cholesterol observed over 6 days of therapy.   "
14882|NCT03090672|"     Musculoskeletal disorders and degeneration represent injuries or pain in the body's joint     ligaments, tendons, muscles, nerves, and skeletal elements that support extremities, spine     and related tissues. Direct injuries and aging contribute to breakdown and inflammation of     these tissues, leading to debilitation and loss of function in these areas. This has major     impact on quality of life, occupational/recreation limitations, and psychosocial     implications.      Many therapies have been employed including medications, physical therapy, occupational     therapy, and a variety of surgical interventions each of which have distinct limitations,     often covering the issues versus providing actual healing and return to function. Many     reports are now available utilizing self-healing options which include use of stem/stromal     cellular therapy or biocellular treatments (either from adipose or marrow) using targeted     placement of cells, matrix and platelet concentrates. Termed cellular or Biocellular therapy     (typically optimized using ultrasound guidance). It is proposed that use of cellular isolates     or cell-stroma derived from the largest deposit of these cells (adipose greater than marrow),     may use in conjunction with targeted placement or as a stand alone methodology intravascular     use.      This study is designed as a interventional means to examine the safety and efficacy of the     use of cellular and tissue stromal vascular fraction in musculoskeletal pain, dysfunction     degeneration or inflammatory disorders.   "
14883|NCT03090659|"     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and     efficacy of LCAR-B38M CAR-T cells in treating patients diagnosed with refractory/relapsed     multiple myeloma (r/r MM).   "
14906|NCT03090360|"     To evaluate the growth of healthy term infants fed an experimental infant formula with a     prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and     human breast milk   "
14884|NCT03090646|"     The investigators are interested in whether or not the use of a small financial incentive     (gift card) increases the rate of follow-up compliance among live kidney donors. The     investigators aim to test this by randomly assigning live kidney donors to the intervention     (gift card at time of follow-up visit) or control arm (standard of care) upon discharge from     their initial kidney donation hospitalization, and tracking follow-up compliance over time.     The study population will be approximately 320 live kidney donors who undergo donor     nephrectomy at Johns Hopkins Hospital (80/year for 4 years).   "
14885|NCT03090633|"     The purpose of this investigation is to evaluate maternal and fetal outcomes following     fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital.      The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the     same effectiveness as open repair of fetal spina bifida, but with the benefit of     significantly lower maternal and fetal complication rates. The fetal benefit of the procedure     will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida     repair will be the avoidance of a large uterine incision. This type of incision increases the     risk of uterine rupture and requires that all future deliveries are by cesarean section. The     use of the minimally invasive fetoscopic surgical technique may also lower the risk of     preterm premature rupture of membranes and preterm birth compared to open fetal surgery.     Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.   "
14886|NCT03090620|"     Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting     antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism     of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis,     decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary     retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or     benzodiazepines.      Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly     despite evidence of safety and efficacy. To demonstrate the utility and safety of     physostigmine, the investigators propose a randomized clinical trial of physostigmine     compared to benzodiazepine for antimuscarinic toxicity.   "
14887|NCT03090607|"     This is a prospective, multi-center, double-blind randomized controlled trial designed to     demonstrate the safety and efficacy of Aluvra for the treatment of GERD.   "
14888|NCT03090594|"     Cryobiopsy has displaced the transbronchial biopsy (BTB) with forceps because it allows to     obtain samples of more representative pulmonary parenchyma with more alveoli, less artifacts     and a greater diagnostic yield. However, some authors report an increase in adverse effects     such as hemorrhage and pneumothorax. The latest ISHLT (International Society for Heart and     Lung Transplantation) consensus of 2007 recommends that with BTB with forceps a minimum of     five tissue samples should be obtained that should contain more than 100 wells or the     presence of two bronchioles to Which may be necessary between 3 and 17 samples. The optimal     number of transbronchial cryobiopsies is unknown in order to obtain maximum performance with     the lowest possible morbidity.      It is proposed to analyze the morphological and histopathological characteristics of each     cryobiopsies individually and in order of extraction, to determine the sensitivity in the     diagnosis of acute rejection as a function of the number of samples. Lung transplant     patients, not admitted to critical units, with BTB indication will be included. A maximum of     6 samples will be obtained by flexible bronchoscope and under general anesthesia.      These data will allow to know the minimum number of specimens that guarantee a histological     and / or bacteriological diagnosis of certainty with maximum effectiveness.   "
14889|NCT03090581|"     The survival of lung transplant patients (PD) is limited mainly by Infections, graft     dysfunction in the immediate postoperative period and chronic dysfunction. Up to 36% have an     episode of acute rejection after transplantation. For the diagnosis of these pathologies,     transbronchial lung biopsy (BPTB) is essential. The classical method is the realization of     BPTB with conventional clamp, but the performance diagnosis is limited. However, the use of     cryoprobes for sampling in other pulmonary pathologies have been shown to achieve a higher     diagnostic yield. The BPTB performance is variable and depends on factors such as sample size     and the presence of artifacts (crushing) produced by the forceps tweezers. The objective     principal is to compare the diagnostic yield of samples obtained with cryoprobe compared to     those obtained with conventional biopsy tweezers. A prospective, randomized, and comparative     study is proposed for all patients in the intensive care unit after lung transplantation in a     24-month period, at Vall de Hebron Hospital. Patients will be divided into two groups:     symptomatic and asymptomatic. The exclusion criteria are the contraindications of the     procedure and the factors which increase the hemorrhagic risk. A flexible bronchoscope     (BF-18BS) will be used and the procedure will be performed according to the technique     conventional. The patient undergoing the procedure will be intubated, sedated and relaxed     under supervision and continuous monitoring by an intensivist. A bronchoalveolar lavage and a     maximum of 6 samples will be obtained. Morphological study (middle area, artifacts,     components, diagnosis), microbiological, histological and anatomopathological according to     the usual protocol. The duration of the procedure, the complications and the frequency with     which the diagnosis obtained after the procedure modifies the therapeutic behavior will be     monitored. These data will allow to evaluate the potential benefits of this procedure in the     diagnosis of pulmonary pathology in lung transplantation.   "
14893|NCT03090529|"     The main purpose of this study is to assess whether exercise training reduces ambulatory     blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients     with resistant hypertension will be recruited and randomized into exercise training or     control groups and followed up for 6 months. The patients in the exercise group will     participate in a 3-month outpatient program. The control group will receive usual medical     care. At baseline, after the intervention and 3 months after the end of the intervention both     groups will undergo several evaluations, including casual and ambulatory blood pressure, body     composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic     function, and endothelial and inflammatory biomarkers.   "
14895|NCT03090503|"     This study compares the efficacy and effectiveness of two of the second-generation     antipsychotics (SGAs) most used in our society in the treatment of schizophrenia     (Aripiprazole and Risperidone) and the investigators do within an assistance program of     early-stage psychosis individuals of the Community of Cantabria, clinical reference for the     treatment of this disease in the Spanish Autonomous Community. Patients are included in a     prospective naturalistic study, open flexible-doses and randomized into one of two possible     patterns of treatment that includes the protocol.   "
14896|NCT03090490|"     This open-label, non-randomized, prospective study will evaluate the risk of symptoms     recurrence during the ten years after antipsychotic discontinuation in a sample of     functionally recovered first-episode patients with schizophrenia spectrum disorder.   "
14897|NCT03090477|"     Owing to effective treatment with tyrosine kinase inhibitors (TKIs), chronic myeloid leukemia     (CML) has become a chronic disease with a rising prevalence globally. Although the     possibility of stopping TKI therapy in CML patients who have achieved deep molecular     responses is a topic of active debate and investigation, life-long treatment remains the     current standard of care. It has been estimated that 3% to 56% of CML patients are not     adherent to their prescribed TKI therapy. Poor adherence to TKIs could compromise the control     of CML, and contributes to poorer survival. CML patients on long-term TKI therapy are prone     to developing certain medication-related issues such as adverse reactions and drug     interactions.Occurrence of adverse reactions even at low grades, has been shown to impact CML     patient's health-related quality of life (HRQoL) and adherence to treatment. However, there     is no prospective high quality evidence showing adherence to TKIs and the associated clinical     outcomes can be improved in CML patients. Therefore, the investigators hypothesize that     medication management intervention by pharmacist might improve adherence to TKIs, and     translate into better disease response and HRQoL in CML patients, when compared to control     arm who receive standard pharmacy service.   "
14898|NCT03090464|"     Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive     treatment plan aimed at meeting multitude therapeutic targets associated with micro- and     macro-vascular risk reduction. There is evidence that patient support in various forms can     have a significant positive impact on adherence to treatment and the meeting of targets in     patients with type 2 diabetes mellitus. The purpose of this study is to evaluate if the use     of a digital disease management tool (Smart phone- web portal-based tool), in addition to     Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM     (such as weight, blood pressure, and lipid levels), will also be evaluated along with     patient-reported outcomes, such as satisfaction with treatment and adherence to their     antihyperglycemic treatment. Study duration is 6 months.   "
14899|NCT03090451|"     People with type 1 diabetes often find exercise very difficult to manage, because of the high     risk for low blood glucose levels. This can occur very quickly once exercise starts and     presents many risks for subjects, such as severe symptoms, confusion, passing out, seizures,     and even coma or death in very severe cases. Preventing low blood glucose levels during and     after exercise is important because physical exercise is a key component of managing     diabetes. It is often hard to correctly adjust insulin infusion rates or doses before     exercise as the relationship between exercise and changes in glucose levels in those who have     type 1 diabetes is still not fully understood. Therefore, the investigators propose this     study to further our understanding in this area.      This study is designed to help separate the effects of insulin from those of muscle work     (non-insulin effects) on the changes in blood glucose levels during aerobic exercise. The     main hypothesis is that the non-insulin effects occur quickly during exercise and account for     the rapid change in blood glucose levels once aerobic exercise begins. These effects can be     separated from the slower changes in insulin sensitivity that occur because of exercise, and     which account for reduced insulin demand even after exercise has stopped. The investigators     will investigate the effects of both moderate and intense aerobic exercise at different     levels of insulin in the body to help separate the insulin and non-insulin effects.      The investigators wish to recruit 26 subjects to take part in this study. Subjects will be     randomly divided into two groups, with 13 in each group. Group 1 will undergo moderate     aerobic exercise, while group 2 will undergo intense aerobic exercise. Each subject will     repeat the exercise study three times on three separate days at least 2 weeks apart, while     having insulin infused at a low, a medium, and a high rate. Subjects will have an IV line     placed in each arm, one for drawing blood relatively frequently during the study, and another     for infusion of insulin, glucose, and a special glucose tracer (non-radioactive). Each study     lasts about 9 hours.      Information from this study will be used to help develop a mathematical model of how glucose     changes during exercise in type 1 diabetes. Such a model of type 1 diabetes and exercise will     be very useful for adjusting insulin doses in patients who use multiple daily injections of     insulin, and can help to guide an automated insulin delivery system, such as the artificial     pancreas.   "
14900|NCT03090438|"     Infertility has been estimated to affect from 6-18% of couples trying to conceive. In 20-30%     of cases, the problem is with the male. Varicocele is a common cause of male factor     infertility (MFI) being responsible for 30-35 % of primary and 69-81 % of secondary MFI.     Varicocele repair has been shown to improve sperm parameters and increase natural pregnancy     rates and the results of assisted reproductive techniques (ART).      There are two possible treatment pathways for varicocele associated male factor infertility.     1) standard IVF/ICSI 2) varicocele repair followed by IVF/ICSI if there is no spontaneous     pregnancy. There is however no consensus as to which pathway is preferable and no randomized     comparative studies have been carried out.      IVF/ICSI is a standard treatment for infertility but frequently requires repeated treatments     to achieve a live birth. The purpose of this study is to determine if the improved sperm     parameters caused by prior treatment of the varicocele will result in improvements both in     overall pregnancy/birth rates and in IVF/ICSI results.   "
14901|NCT03090425|"     In a hitherto ill-defined proportion of patients with inflammatory/familial cardiomyopathy,     the phenotype dilative cardiomyopathy (DCM) is assumed to be the endstage of a multifactorial     etiopathogenetic pathophysiology. Precipitating factors include enhanced autoimmunity,     predisposition for viral infections, environmental factors in addition to a specific 'genetic     background' of the individual patient. It is unresolved, whether the susceptibility to     immunologically mediated myocardial damage reflects the presence of genetic risk factors     shared by other autoimmune diseases, or is cardio-specific with individual predisposing     factors. Aims of the project are the search for a genetic link or oredisposition to     autoimmune diseases in patients with familial / inflammatory DCM.   "
14903|NCT03090399|"     In this retrospective analysis investigators will study the effects of using a minimally     invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants     will compare a control group to a case group; in both groups ASA 1 patients suffering from     advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic     was managed by using the FloTrac system; in the control group a standard hemodynamic     monitoring was used.   "
14907|NCT03090347|"     In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary     fat then this increases the chance of it being stored in the liver, which is related to     increased risk of heart disease and type 2 diabetes. It has been suggested that having a diet     high in sugars or certain fats, may cause the fat tissue and liver to change how they     function; we would like to investigate this in detail.   "
14908|NCT03090334|"     This is a multicenter, prospective, open-label, randomized trial. Patients with severe     abdominal condition developing severe sepsis or septic shock and receiving broad spectrum     antibiotic and antifungal treatment will be randomized (1:1) to:        1. discontinue antifungal treatment based on negative (<80 pg/ml) result of 1,3          beta-d-glucan performed on day 0,3,6 and 10        2. continue antifungal treatment according with attending physician's decision.   "
14909|NCT03090321|"     The MyHeart Counts Cardiovascular Health Study will utilize mobile health capabilities of     smartphones and wearables to assess daily activity measures of the general population and     compare these to measures of cardiovascular health risk factors and fitness. How people     divide their time among exercise, sedentary behavior, and sleep all affect cardiovascular     health, yet to date these have largely gone unmeasured. With the advancement of phone sensors     and wearable fitness tracking devices these factors are now more straightforward to gather     and measure. The use of smartphones by a large segment of the population allows for data     collection on an unprecedented scale. The investigators aim to amass activity and     cardiovascular health data on thousands of participants as well as provide significantly more     quantitative data on type,duration, and intensity of daily activities.      In the second phase of the MyHeart Counts Cardiovascular Health Study (Randomized Assessment     of Physical Activity Prompts In A Large Ambulatory Population) the researchers will conduct a     randomized controlled clinical trial of four different physical activity prompts     (intervention) and their effect on the level of physical activity in the study population as     measured by change in step count.   "
14910|NCT03090308|"     The study included 20 adult patients presented by multiple fractured ribs (flail segment)     with thoracic trauma severity score (TTSS) between 5 and 15. All patients received     mid-thoracic epidural analgesia with 0.125% Bupivacaine and 1 μg/ml fentanyl. The patients     were ventilated using non-invasive positive pressure ventilation (NIPPV). Follow up arterial     blood gases, chest X-ray and CT scan were obtained. Parameters to be recorded: Patient's     characteristics and clinical data including pulmonary contusion, number of fractured ribs,     pleural involvement, PaO2/FiO2 ratio on admission, weaning outcome, duration of NIPPV, length     of stay in ICU (LOS ICU), complications and mortality rate.   "
14911|NCT03090295|"     The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to     create pictures of the spine in three dimensions. This may allow the physician to view the     spine in more detail for procedures such as spinal anesthesia and other diagnostic     procedures.      We aim to assess the benefit of using both the Accuro and traditional landmark palpation     technique to determine accurate spinal level in women who undergo cesarean section. This     study will also assess provider preference for use of both Accuro and palpation compared with     palpation alone or use of Accuro alone.      Anesthesia Providers will first identify the L4/L5 space using the traditional technique of     palpating the iliac crests to estimate spinal level, which will be marked with a single dot     from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5     interspace.      Results will be compared to results obtained in IRB 18070 Handheld 3D lumbar spine     navigation: A clinical validation study RM002 where subjects who were undergoing a C-section     were randomized to either palpation or Accuro alone.   "
14912|NCT03090282|"     The investigators planed to observe the microbiome of an aggressive periodontitis patient,     during mechanical treatment, surgery(if indicated) and implant placement. The investigators     designed to observe the changes after mechanical treatment.Then, the investigators will     compare the sub-mucosa microbiome of implant and the subgingival community. The investigators     expected a different community after treatment, and there could be similarity between implant     and nature teeth.   "
14913|NCT03090269|"     This phase II pilot study aims at evaluating the benefits and the risks of methylphenidate     (Concerta®) for the treatment of cocaine/crack dependence in terms of cocaine/crack use     reduction and adverse events.   "
14914|NCT03089216|"     The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated     with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching     application under two different time protocols, and dentifrice containing arginine 8% and     carbonate calcium use. One hundred eight participants who meet the study inclusion criteria     will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine     and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color.     The data collected will be submitted to the factorial statistical analysis for evaluation of     color and chi-square test for tooth sensitivity (α = 5%).   "
14915|NCT03089203|"     This is a single center, single arm Phase I study to establish the safety and feasibility of     intravenously administered lentivirally transduced dual PSMA-specific/ TGFβ-resistant CAR     modified autologous T cells (CART-PSMA-TGFβRDN cells) in patients with metastatic castrate     resistant prostate cancer.   "
14931|NCT03090243|"     Our trial examined the intraocular pressure measurements differences, before and after     virtual colonoscopy examination.   "
14932|NCT03090230|"     The purpose of this study is to investigate the safety and effectiveness of the RelayPro     Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta     (DTA)   "
22913|NCT02985684|"     Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous     closure of ostium secundum atrial septal defects (ASDs)   "
15484|NCT03082794|"     Negative-calorie diet is among the popular dieting guides for weight loss; however, there is     still little knowledge about this method. The present study aimed to determine the effects of     negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with     low-calorie diet in men.   "
14917|NCT03089177|"     The investigators previous studies show that community gardening is associated with reduction     of key health behaviors for cancer prevention in diverse populations. Community gardeners eat     more fruits and vegetables per day, are more physically active, and are more likely to avoid     age-associated increase in body mass index (BMI). The effect is partially explained by the     finding that gardeners are more socially involved, and feel more social support than     non-gardeners.      The investigators propose a randomized controlled trial to determine whether community     gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult     population and elucidate the pathways that shape cancer-preventive behaviors. A randomized     controlled trial is needed to demonstrate that the observed behavioral differences are due to     the effect of gardening as an intervention rather than self-selection by gardeners.   "
14918|NCT03089164|"     Hemodynamic measurements obtained during pulmonary artery catheterization are essential for     the diagnosis and classification of pulmonary hypertension. Traditionally, right heart     catheterization (RHC) is done in the supine position. Cardiac output is known to change     significantly based on position, due to the effects of gravity on venous return. There has     not been a systematic investigation into these postural effects on pulmonary arterial     pressures nor their effect on the diagnosis of pulmonary hypertension. It is our intent to     study the differences in measurements obtained during RHC when the patient is supine, seated,     and standing.   "
14919|NCT03089151|"     An interdisciplinary team with extensive garden study experience conducted a pilot randomized     controlled clinical trial to see whether gardening reduced risk factors for diseases like     cancer and heart disease. The pilot trial will provide preliminary data on associations     between human microbiome, diet, physical activity, and social interactions and the outcomes     of weight status and key inflammatory biomarkers.   "
14920|NCT03089138|"     Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome:     A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase     2b Study   "
14921|NCT03089125|"     This research study is evaluating a behavioral intervention designed to help people with     advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).   "
14922|NCT03089112|"     A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug     interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers   "
14923|NCT03089099|"     As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive     status, the biological behavior of tumor cells that dissociated from primary lesions changed.     Considered a liquid biopsy, these circulating tumor cells (CTCs) can show how a patient's     cancer responded to treatments. The purpose of this study is to determine whether     sequentially analyzing the expression of molecular markers in high volume circulating tumor     cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic     effects and outcomes of these patients.   "
14924|NCT03089086|"     To estimate the effect on carriage, approximately 60,000 year 10, 11, and 12 students will be     offered 4CMenB vaccination in South Australia through schools over the study period with 50%     receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior     pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the     difference in carriage prevalence of all serogroups of N. meningitidis and serogroup B     between vaccinated and unvaccinated participants.   "
14925|NCT03089073|"     Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia   "
14926|NCT03089060|"     Amputation injuries of the fingertip are common in all ages. For decades it is known that     conservatively treated fingertips can regenerate skin and soft tissues to form a functionally     and cosmetically excellent new fingertip. Unfortunately, little is known about the mechanisms     controlling this ability that, in humans, is confined to the fingertips. Even less is known     about the bacteria that regularly colonize these wounds without noticeable negative impact on     regeneration and healing. Medical evidence on fingertip regeneration in humans is largely     limited to retrospective studies and case reports. This study will be the first randomized     controlled trial on the conservative treatment of fingertip amputations in children and     adults.      When managed without surgery, self-adhesive polyurethane film dressings are commonly used to     establish a wet chamber around the injury. This provides the best conditions for tissue     regeneration inhibiting the formation of scar tissue at the same time. Unfortunately these     dressings do not offer mechanical protection, they do not stick to wet skin and leak     malodorous wound fluid. The investigators therefore developed a silicone finger cap that     deals with these problems offering a mechanically protected, wet chamber around the injury     for optimal regeneration conditions. This finger cap also offers a puncturable reservoir for     excess wound fluid, which by this route can be routinely analyzed for diagnostic and research     purposes.      This randomized controlled trial will for the first time test acceptance, safety and efficacy     of this novel medical device in comparison with conventional self-adhesive film dressings     while gathering information on the clinical course and outcome of conservatively treated     fingertip amputation injuries.      Based on sample size calculations for primary outcome, 22 patients older than 2 years will be     enrolled within 24 hours after having suffered an injury distal to the distal interphalangeal     joint comprising all layers of the skin with a substance defect that cannot be primarily     adapted without further shortening of the finger or plastic surgery. Participants are     randomly assigned to start their treatment for the first two weeks either with a conventional     film dressing or with the novel silicone finger cap. They will be changed to the other     modality for another two weeks before the patient or the guardian can decide, if they would     want the film dressing or the finger cap for the rest of the treatment.   "
14927|NCT03089047|"     To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs),     the investigator will emulate critical conditions by safely maximizing stress on the     cardiovascular system, in an elective, feasible volunteer study. VO2max will be measured in     an anemic, post-donation, pre-transfusion state, and also after transfusing 18-day-old,     autologous blood randomized to standard storage or standard storage with rejuvenation. The     investigator hypothesizes that transfusion of standard PRBCs is less effective at increasing     oxygen delivery (measured by VO2max) compared with transfusion of rejRBCs   "
14928|NCT03089034|"     Chronic Heart Failure (CHF) is one of the leading causes of death in Singapore. Although it     is well established that CHF patients in Singapore are less likely to be referred to     palliative care services than cancer patients, little data is available on end-of-life (EOL)     experience of advanced CHF patients in Singapore, including the inter-relationships between     patient decision-making, quality of life trajectories, and health and cost consequences.   "
14929|NCT03089021|"     This study investigate the short term effect of Maitland in comparison to Mulligan     mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain     pressure threshold, rang of motion, joint position sense, disability, and to evaluate the     interaction with psychological factors.      Study design: experimental study   "
14930|NCT03089008|"     The purpose of the present study is to examine the long-term effect of eccentric exercises     compared with stretching exercises on patients with achillodynia.   "
14933|NCT03090217|"     Vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting     about one third of women. In this randomized controlled trial, the effect of a pelvic     physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological     cancer undergoing gynecological brachytherapy. In addition, the investigators will explore an     improvement in quality of life, sexuality, and contractile function of the pelvic floor     muscles.   "
14934|NCT03090204|"     The analysis of the systolic function (contractility) of the right ventricle (RV) is     fundamental and central in many pathologies in intensive care unit. It can guide physicians     in choosing therapeutics. The conventional ultrasound markers of RV function evaluation     currently used are influenced by RV loading conditions, impairing their capacity to     approximate a true contractility analysis. Myocardial strain imaging is a recent echographic     technique that allows, among other things, to evaluate RV systolic function. It is a     reproducible index with early variations which, if it proved to be independent pre-load,     would help to better appreciate the RV contractility.   "
14935|NCT03090191|"     The Clover trial is evaluating an investigational vaccine that may help to prevent     Clostridium difficile infection. Participants in the study are adults 50 years of age and     older, who are at risk of developing Clostridium difficile infection. The study will assess     whether the vaccine prevents the disease, and whether it is safe and well tolerated.      Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed     for up to 3 years after vaccination for potential Clostridium difficile infection.   "
14936|NCT03090178|"     Atopic dermatitis is a chronic disease with a high impact on patient's quality of life.     Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy     is generally measured by healthcare professionals during consultations with both questioning     and visual examination of the lesions. Quality of Life (QoL) can also be evaluated     retrospectively with the Dermatology Life Quality Index (DLQI) scale. Collecting data     retrospectively introduces a significant recall bias that can be addressed by collecting data     in Real World (RW). Real World data collection is prospective and take place within the     patient's own environment. While data collection is generally done with diaries, it has been     demonstrated that smartphone and connected devices were able to produce more precise and     granular data than traditional methods.   "
14937|NCT03090165|"     This is an open label, multi-institutional, single arm phase II trial of ribociclib in     combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization     or blinding is involved.   "
14938|NCT03090152|"     Total hip arthroplasty can be associated with significant postoperative pain. Side effects of     pain management may impair participation in physical therapy and slow readiness for discharge     from the hospital. In a previous study done by the investigators' group, epidural patient     controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more     favorable pain profile with ambulation, but greater side effects compared to injection of a     peri-articular cocktail. The use of opioid was greater in the peri-articular injection group     (PAI). There was no difference in length of stay. In view of the controversy over opioid use,     the investigators would like to develop an optimal opioid sparing pain management approach by     comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in     conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain     control while minimizing opioid use and side-effects.   "
14939|NCT03090139|"     The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF     therapy in UC and CD participants.   "
14940|NCT03090126|"     The purpose of the study is to assess the therapeutic education of patients with chronic     respiratory failure who start to be treated with non invasive ventilation and during the     first six months of ventilation.   "
14941|NCT03090113|"     This is a randomized, double blind, placebo-controlled, parallel, multicenter research in     order to evaluate the effect of Shuxuetong injection in prevention of symptomatic or     asymptomatic new cerebral infarction within 10 days.      Subgroup study：Evaluate the role of advanced diagnostic technique in identifying potential     causes of Embolic Stroke of Undetermined Source (ESUS).   "
14942|NCT03090100|"     The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab     for the treatment of participants with moderate to severe plaque-type psoriasis.   "
14943|NCT03090087|"     The purpose is to investigate how the adenosine affects the diameter regulation of retinal     arterioles during changes in oxygen tension. A deeper understanding of the mechanisms     involved in diameter regulation of retinal arterioles during changes in oxygen tension can be     used to obtain a more detailed understanding of diseases where changes in the diameter     regulation of retinal vessels are involved in the disease pathogenesis and possibly point to     new therapeutic options for patients with retinal vascular disease, such as diabetic     retinopathy and retinal vein thrombosis.      Preliminary, a routine ophthalmological evaluation, measurement of blood pressure, and     electrocardiogram will be preformed to insure that only healthy test persons are included in     the study.      The test persons will be randomly allocated to two groups, one group in which protocol 1 is     followed by protocol 2, and the other group with the two protocols performed in the reverse     order.      Protocol 1: Using the DVA, a video recording will capture the diameter of retinal vessels and     the changes occurring during stimulation with flickering light. The recording lasts 4.5     minutes and is preformed before and after intravenous injection of adenosine.      Protocol 2: The procedures are similar to those of protocol 1 but are performed during     breathing of a gas mixture with a reduced oxygen tension to 12,5 %, which results in a     reduced oxygen saturation in the blood to 85-90 %.   "
14944|NCT03090074|"     Risk-patients for diabetes or patients that are diagnosed with this condition but who are not     treated with insulin are randomized two times, according to diet and according to the type of     support:      Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization     with regard to type of psychological support. Either according to Acceptance and Commitment     Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support     is given as group therapy.      Two-hundred patients are recruited and each patient is followed for two years.   "
14945|NCT03090061|"     This study will be conducted to assess diagnostic predictive values of a light induced     fluorescence intraoral camera versus those of the visual-tactile assessment method according     to FDI criteria in clinical evaluation the margins of resin composite restorations   "
14947|NCT03090035|"     Objective:      Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic     hepatitis C infection. This study was conducted to find out the frequency of different IL-28B     (rs12979860) genotypes in patients with chronic hepatitis C (HCV genotype type 2 & 3)     infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of     IL-28B genotypes in achieving Sustained Virological Response (SVR).      Methods:      In this non-randomized observational study, ninety eight (98) patients with diagnosis of     chronic hepatitis C were included. In all patients, Peg-IFN plus Ribavirin were given in     standard doses for 24 weeks. End treatment response, sustained virological response, and     relapse rate were the primary endpoints of this study. Analysis of IL28B (rs12979860)     polymorphism (CC, CT and TT) was performed by PCR-RFLP protocol.   "
14948|NCT03090022|"     Incisional hernia is a common complication in visceral surgery and varies between 11 and 26%     in the general surgical population. Patients requiring emergency laparotomy are at high risk     for the development of incisional hernia and fascial dehiscence. Among this population the     incidence of incisional hernia in patients undergoing emergency surgery varies between     33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal     incarceration, chronic discomfort, pain, and reoperation and typically require implantation     of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form     of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up     to 44%.      The gold standard for abdominal wall closure during elective and emergency operations is a     running slowly absorbable suture. In the elective situation it has been shown that     prophylactic mesh implantation in high risk patients reduced the incidence of incisional     hernia significantly.      The investigators and others have shown that mesh implantation in patients undergoing     emergency laparotomy or in contaminated abdominal cavities are safe .      With a randomized controlled trial the investigators now aim to compare the incidence of     incisional hernia after prophylactic mesh implantation versus standard of care in patients     requiring emergency laparotomy.   "
14949|NCT03090009|"     Dental implants are often used to replace missing teeth. In fact, in the US over 700,000     implants are places every year and over 2 million implants are places world wide.     Peri-implant mucositis in an inflammatory condition affecting dental implants and is     recognized as a risk factor for peri-implantitis (a condition affecting the bone around     implants and eventually leading to implant loss). The prevalence of Peri-implant Mucositis     has been reported in the literature to range from 50-90% whereas the prevalence of     Peri-implantitis has been reported as high as 20%. it is commonly believed that a dysbiotic     microbiome is the primary cause for these conditions.      The inflammatory burden around diseased implants creates a high-protein environment which is     necessary for the survival of pathogenic bacteria. It is logical, therefore, that reducing     inflammation by Non Steroidal Anti-Inflammatory Drugs (NSAIDs) may create a shift in the     dysbiotic microbiome to a symbiotic microbiome. The aim of the current study is to test the     effects of oral NSAIDs on the peri-implant microbiome.   "
14950|NCT03089996|"     This study will compare the techniques of piezocision and alveolar corticotomies in     accelerating orthodontic tooth movement. It will consist of a split-mouth study in patients     who require the extraction of the first premolars to correct malocclusion. The canine will be     retracted using these surgical techniques, as well as without any intervention, being this     the control side. In addition, will be evaluated the inflammatory biomarkers present in the     gingival crevicular sulcus during the dental movement, as well as data related to pain and     discomfort.   "
14951|NCT03089983|"     The purpose of this study is to conduct empiric studies of tuberculosis (TB) among prison     inmates with a history of opioid dependence. This includes: a) comprehensive TB diagnostic     study (symptom screening, chest x-ray, tuberculin skin test, acid-fast bacilli smear, Gene     Xpert, and sputum culture) to determine best practices for screening HIV+ and HIV- prisoners;     b) A RCT of latent TB infection prevention strategies among HIV+ and HIV- prisoners with high     prevalence of hepatitis C (HCV) using standard 40-week daily isoniazid (40H) vs short-course     weekly isoniazid + rifapentine (12HR); and c) a 3-arm preference trial comparing post-release     TB treatment completion in patients on opioid agonist treatment (methadone vs naltrexone     implant) vs no opioid agonist treatment in patients being treated for active or latent TB who     are transitioning to the community. Investigators will also use this data, and publicly     available data to complete agent-based modeling for comparative and cost-effectiveness of     various TB screening and treatment strategies among prisoners, and upon community transition     post-release from prison.   "
14952|NCT03089970|"     Respiratory virus infections cause a majority of asthma exacerbations in the fall to spring     months. Current diagnostic platforms for respiratory viruses have limitations including cost,     availability, and invasiveness. The use of noninvasive breath collection to analyze breath     metabolites may be used to differentiate virus-infected asthmatics from other causes of acute     asthma exacerbations.   "
14953|NCT03089957|"     Since strategies were applied in intensive care medicine, including low tidal volume     ventilation, fluid resuscitation, use of antibiotics, restrictive transfusion strategy and     bundle of ventilator therapy, the incidence of Acute Respiratory Distress Syndrome (ARDS) has     been decreased recent years. However, the mortality of severe ARDS is still higher to 45%.     Few medications did were indicated to be effective in working on development of ARDS.     Different with other disease, ARDS were difficult to prevent in its later stage like a domino     effect. The medication interventions are all used after ARDS was developed, including     ulinastatin. The investigators hypothesized that the key point in failure of medication     therapy is the delay timing of medication intervention. If given the preventive strategy,     such as ulinastatin, the incidence or the severity of ARDS might be decreased. Therefore this     is a randomized controlled trial to test the hypothesis of the preventive effect of     ulinastatin in ARDS.      This is a multi-center, randomized, double blinded, placebo controlled study.   "
16477|NCT03069807|"     This study investigates whether recent migrants to the United Kingdom are more likely to     complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the     community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB     clinic.   "
15248|NCT03085875|"     This study will take advantage of the open source framework of ResearchKit developed by Apple     to bring research directly to participants. Using the ResearchKit platform makes it easier to     enroll large numbers of participants and carry out real-world health research to answer     questions important to a broad population.   "
14954|NCT03089944|"     A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to     demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing     (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB)     combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in     treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated     cirrhosis.   "
14955|NCT03089931|"     Low back pain may be reduced after cervical spinal surgery   "
14956|NCT03089918|"     The purpose of this study is to investigate the total body biodistribution and radiation     dosimetry of 11C-JNJ-63779586 by Positron Emission Tomography (PET) in healthy young adult     males (Part A); to estimate and compare the uptake, distribution, and clearance of     11C-JNJ-63779586 in the brain by PET between mild Alzheimer Disease (AD) participants     (males/females) and age- and gender-matched control participants (Part B), corrected for     regional cerebral blood flow differences; and to model the tissue specific kinetics of     11C-JNJ-63779586 in human brain with the appropriate input function (IF) (Part B).   "
14957|NCT03089905|"     There is considerable evidence that most general anaesthetics modulate brain development in     animal studies. The impact is greater with longer durations of exposure and in younger     animals. There is great controversy over whether or not these animal data are relevant to     human clinical scenarios.      The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists     such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous     oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha     2 agonists (such as dexmedetomidine).      Some, but not all, human cohort studies show an association between exposure to anaesthesia     in infancy or early childhood and later changes in cognitive tests, school performance or     risk of developing neurodevelopmental disorders. The evidence is weak due to possible     confounding.      A recent well designed cohort study (the PANDA study) comparing young children that had     hernia repair to their siblings found no evidence for a difference in a range of detailed     neuropsychological tests. In that study most children were exposed to up to two hours of     anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under     regional or general anesthesia and has found no evidence for a difference in neurodevelopment     when tested at two years of age. The GAS and PANDA studies confirm the animal data that short     exposure is unlikely to cause any neurodevelopmental impact.      The impact of longer exposures is still unknown. In humans the strongest evidence for an     association between surgery and poor neurodevelopmental outcome is in infants having major     surgery. However, this is also the group where confounding is most likely.      The aim of our study is to see if a new combination of anaesthetic drugs results in a better     long-term developmental outcome than the current standard of care for children having surgery     lasting at least 2..5 hours.      Children will be randomised to receive either a low dose     sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic.      They will receive a neurodevelopmental assessment at 3 years of age to assess global     cognitive function.   "
14958|NCT03089892|"     Chemotherapy is effective and most often used to treat cancer. The common drugs used on     gynecologic cancer treatment include platinum compounds like cisplatin and carboplatin, which     combined with taxane, topotecan, or liposomal doxorubicin to date. The most side effects of     chemotherapy are esophagitis, mucositis, anxiety, nausea, vomiting, abdominal convulsion,     painful swallowing, fatigue and sometimes diarrhea, dizziness, allergy (rash, itching),     neutropenia, thrombocytopenia (fever, chills, cough, pain), anemia and bleeding.      Cancer-related fatigue (CRF), an indicator of quality of life, is a highly prevalent symptom     (75-80%) during treatment and in patients with advanced cancer, yet is sometimes ignored.     Fatigue affected their life more than pain. Proposed criteria for CRF have been adopted for     inclusion in the International Statistical Classification of Disease and Related Health     Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth     researches on CRF are needed in Taiwan. Patients with CRF in need of improvement, commonly     use nutrition supplements, acupuncture, healthy food, massage, drugs, etc. Hence, patients     with CRF could consult their vital physician for an appropriate treatment. Furthermore,     several drugs could be chosen to relieve CRF, including anemia drugs, antipsychotics or     Astragalus polysaccharides extract.      The objective of this retrospective study is to collect and analyze the medical records of     gynecologic cancer patients who had accepted prescription drug treatment for cancer-related     fatigue under chemotherapy in the Department of Obstetrics & Gynecology of Tri-Service     General Hospital from December 1st, 2015 to November 30th, 2017. This study will compare the     fatigue improvement profile by different chemotherapy regimens, tumor stage, CRF treatment,     etc. and investigate the association between the profile of fatigue improvement and fatigue     cluster (weight loss and other symptoms of functional assessment of cancer therapy). These     results will supply physicians with more understanding about CRF, and help them to enhance     the quality on gynecologic cancer care to being perfected in the future.   "
14959|NCT03089879|"     GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella     sonnei.      A post-hoc analysis of subjects who participated in the parent study showed significantly     different responses in subjects with detectable versus undetectable antibody titres at     baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic     in completely naïve adults.      This study was then designed to further characterize the immunogenicity profile of the     vaccine and to evaluate whether it was able to induce an immunological memory response.   "
14960|NCT03089866|"     The main goal of this study is to allow the anesthesiologist to make a more informed decision     about the anesthetic requirement of a person prior to starting anesthesia. The preliminary     data collected in this study will support a larger investigation aimed at gaining a better     understanding of anesthetic susceptibility in general and in the elderly population which     appears to be at greater risk for Postoperative Cognitive Dysfunction (POCD)      POCD is a short-term decline in cognitive function (especially in memory and executive     functions) that may last from a few days to a few weeks after surgery. In rare cases, this     disorder may persist for several months after major surgery. POCD is distinct from emergence     delirium. It occurs most commonly in older patients and those with pre-existing cognitive     impairment. POCD is common in adult patients of all ages at hospital discharge after major     non-cardiac surgery, but only the elderly (aged 60 years or older) are at significant risk     for long-term cognitive problems. The body's inflammatory response to surgery likely plays an     important role, at least in elderly patients. Investigators also postulate that a relative     'anesthetic overdose' may be a significant risk factor. Hence, being able to make a better     judgment on the dose needed for an individual is extremely important.   "
14961|NCT03089853|"     This is a prospective randomized controlled study to test the hypothesis that neuromuscular     electrical stimulation (NMES) and remote pulmonary rehabilitation at home offered via a smart     technology, called Smart TeleHealth, results in a reduction of systemic inflammation, via     reduction of skeletal muscle tissue inflammation, and thereby improves functional capacity,     and thus, reduces the rate of readmissions following hospitalization for acute exacerbations     of Chronic Obstructive Pulmonary Disease (COPD). This study will enroll up to 40 participants     at UAB, about 30 will get Smart Telehealth and NMES, and 10 will get usual care.   "
14962|NCT03089840|"     This trial is to assess the safety and efficacy of normothermic machine perfusion (NMP) as an     organ preservation method prior to transplantation using the OrganOx metra™ device.   "
16755|NCT03066232|"     Study the prevalence of delirium among old persons with home-nursing care living in the     community. By recruiting the persons in a stable phase, the investigators wish to study the     influence of an episode of delirium upon further cognitive and physical function.   "
14963|NCT03089827|"     Participants enrolled in the Alzheimer's Disease Clinical Core at Wake Forest School of     Medicine will be invited to take part in this study. The purpose of this study is to identify     and measure the amount of a protein called amyloid in the brain.It is thought that the build     up of amyloid may be related to the development of Alzheimer's disease.   "
14964|NCT03089814|"     Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia     and 5-min reperfusion) has not been well documented. In previous studies, there was     difference in changes in microcirculation, such as recovery slope and occlusion slope,     between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which     reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease     during repeated ischemia-reperfusion cycle by its protecting effect, however there has not     been well-conducted study. The purpose of the study is to evaluate the changes in     microcirculation measured by tissue oxygen saturation during ischemic conditioning between     healthy volunteers and cardiac surgery patients.   "
14965|NCT03089801|"     In order to enhance access to clinical and mental health services for Veterans who have     geographic, clinical, or social barriers to in-person care, VA Offices of Connected Care and     Rural Health began distributing 5,000 tablets to Veterans with access barriers in 2016. The     objective of this Quality Improvement evaluation is to:        1. Understand characteristics of Veterans who received tablets, the frequency and ways in          which they used the tablets, and the effects of tablet use on access to VA services.        2. Through a survey of Veterans, evaluate patient experiences using the tablets, and          determine how tablets influenced patients' experiences with VA care, including their          satisfaction, communication with providers, and access to needed services.        3. Identify implementation barriers and facilitators to tablet distribution and use through          interviews with clinicians and staff in a purposive sample of VA facilities        4. Evaluate the effects of tablet use on chronic medical condition outcomes (e.g.,          hypertension, diabetes) and mental health treatment initiation and engagement (e.g., for          depression, PTSD, and substance use).   "
14966|NCT03089788|"     In this Project we will monitor the symptoms of cat allergic participants who live together     with a cat which is immunized with FEL-CMV using the novel symptom recording method     HypoScore, a General weekly symptom score, and a skin prick test before and after     immunization of the cat. This project may enable us to determine if the scoring System and     the tests are able to detect a difference in participant symptoms before and after     immunization of the cats.   "
14967|NCT03089775|"     This two cohort study (Cohort A and B) is being conducted to assess the safety and efficacy     of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type     hypersensitivity reaction.   "
14968|NCT03089762|"     Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of     fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated     the safety and preliminary efficacy of administering SVF and PRP intra-articularly into     patients with osteoarthritis grade 1 and 2.   "
14969|NCT03089749|"     The aim of the study is to quantitate Central Nervous System (CNS) autoantibody development     in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial     brain surgeries.   "
14970|NCT03089736|"     The purpose of this study is to evaluate the effect of individual education and individual     self-care measures on pain intensity, perceived health, mood and sleep during and after     treatment with radiotherapy for head and neck cancer.   "
14971|NCT03089723|"     Although a common problem, hand osteoarthritis (HOA) is less studied than knee and hip. In     the age group of 71-100 years, the prevalence of symptomatic HOA reaches 26% of women and 13%     of men. These patients lose hand strength and have difficulty with day-to-day manual     activities. The main joints involved are the proximal and distal interphalangeals and the     carpometacarpal joint of the thumb. In the educational Project PARQVE, the prevalence of HOA     was 23.7% at inclusion in the program, and 47.4% after one year, with loss of grip strength.     There is controversy over the effect of viscosupplementation in the treatment of     rhizarthritis when considering pain. However, strength is a very important function parameter     that must be evaluated for function and quality of life maintenance. Concerned about the     importance of maintaining strength and function in our program (PARQVE), we have added     specific exercises tom improve hand strength and range of motion. Trying to optimize the     treatment and confronting questions about the effect of the joint wash, called placebo in the     comparative studies with corticosteroid and/or hyaluronic acid injection, we did a work where     all the patients will be washed with physiological saline solution but a group, after     emptying, will receive 1mL of hyaluronic acid with mannitol.      PURPOSE: To compare isolated lavage with lavage followed by injection of hyaluronic acid with     mannitol into carpometacarpal osteoarthritis joint of the thumb.      METHODS: Forty joints of patients with multiple osteoarthritis (rhizoarthritis, including)     and comorbidities (two or more of: overweight or obesity, hyperglycemia, dyslipidemia,     hyperuricemia, hypertension) will be allocated into two groups: Lavage (LS) and Lavage and     Injection Hilauronic acid (LO). Both groups will undergo joint lavage with saline solution.     The LO group will receive the 20 mg / mL hilauronic acid injection with 5mg mannitol. Both     groups will be guided in the clinical treatment of osteoarthritis and metabolic syndrome and     will be given daily exercises for the hands. They will be evaluated with the quick DASH     questionnaire, Sollerman Test and by measuring the palmar, lateral and pulp-pulp grip     strength, in addition to measuring the ROM and VAS pain moments immediately prior to the     procedure, one, three and six months after the articular procedure.   "
14972|NCT03089710|"     Perioperative fluid management is crucial for patients' outcome. Muller et al developed a     Mini-fluid challenge method  to predict fluid responsiveness and the efficacy. The     investigators design the study to investigate the effectiveness of mini-fluid challenge test     in prone position surgery.   "
14973|NCT03089697|"     This study is performed to evaluate safety and to explore the efficacy of a single     intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard     treatment, for persistent Staphylococcus aureus bacteremia in patients, for more than 48     hours even after antibiotic treatment to which Staphylococcus aureus is susceptible.   "
14974|NCT03089684|"     This NHANES analysis compares self-reported dietary folate with serum and red blood cell     folate status in U.S. adults.   "
15003|NCT03089307|"     The present study aims to identify and compare the efficacy and safety of two different     session frequency protocols (once vs twice per week) of low intensity extracorporeal     shockwave treatment (LI-ESWT) using Aries ED device, in men with mild-moderate and severe     vasculogenic ED, who have previously responded to oral PDE5-Is   "
15004|NCT03089294|"     The present study aims to identify the efficacy saturation effect of low intensity     extracorporeal shockwave treatment (LI-ESWT) using Aries ED device in men with mild-moderate     and severe vasculogenic ED, who have previously responded to oral PDE5-Is. The efficacy and     safety of 4 different session frequency protocols will be compared.   "
15005|NCT03089281|"     The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients     with a prolonged RV-LV interval.   "
14975|NCT03089671|"     Background: The risk of ureteric injury at the time of pelvic reconstructive surgery can be     as high as 3% and the American College of Obstetricians and Gynecologists has stated that     intraoperative cystoscopy should be done after all such procedures. Intravenous indigo     carmine was routinely given during surgery to colour the urine bright blue and allow for     assessment of ureteric integrity. In 2014, indigo carmine was no longer available worldwide     and since then, surgeons have been searching for suitable alternatives. Vitamin B is a water     soluble vitamin that colours the urine bright yellow and can be given immediately before     surgery to help with ureteric visualization. Alternatively, 5% dextrose in water (D5W) can be     used as the instillation fluid during cystoscopy to allow for urine jet visualization due to     the difference in fluid viscosity. Both agents have been shown to be better than instillation     with normal saline and are affordable and accessible in Canada.      Objective: To identify which agent is superior for intraoperative ureteric visualization at     the time of cystoscopy by determining the difference in detection rate of both ureteric jets     using either preoperative oral vitamin B or intraoperative cystoscopic distension with D5W.      Methods: This study will be a three-site (Mount Sinai Hospital, Sunnybrook Health Sciences     Centre, St. Michael's Hospital), double-blinded, randomized control trial whereby female     patients undergoing pelvic reconstructive surgery will be randomized to receive either     preoperative vitamin B or intraoperative D5W cystoscopic instillation fluid. Parameters     measured during surgery will include whether both ureteric jets were seen, time to     visualization of both ureters, colour of jets, and surgeon satisfaction. Patients will also     be seen at one week after surgery to assess for urinary tract infection. Sample size     calculation based on previous studies demonstrated a need for 125 patients per study arm.      Anticipated Clinical Significance: The findings of this study will be relevant to all     surgeons performing intraoperative cystoscopy where ureteric visualization is required. The     investigators believe the outcome of this study will help make cystoscopy shorter and more     efficient for surgeons who often feel the pressure of time constraints within the operating     room setting. In turn, decreasing the time of cystoscopy may reduce operating times which     will benefit both the patient and hospital.   "
14976|NCT03089658|"     Expanded access to Avelumab solution for infusion will be made available for adult patients     with mMCC whose disease has progressed after receiving at least one prior chemotherapy.   "
14977|NCT03089645|"     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and     antitumor activity in adult subjects with selected advanced solid tumor malignancies.   "
14978|NCT03089632|"     Patients with type-1 diabetes are more susceptible to motility-related upper gastrointestinal     symptoms. Dietary interventions are one of the treatment pillars for these symptoms. Many     gastrointestinal conditions other than celiac disease, are being increasingly treated with     gluten-free diet (GFD). The role of GFD in non-celiac type-1 diabetic patients with     dyspepsia-like symptoms has not been assessed before. In this study, type 1 diabetes patients     with concomitant upper gastrointestinal symptoms will be asked to follow a 1-month GFD to     assess changes in upper gastrointestinal symptoms and gastroduodenal motility before and     after the dietary intervention.   "
14979|NCT03089619|"     Investigation of the volume stability of the alveolar ridge, the bone structure and soft     tissue appearance at a delayed dental implantation using two bone substitute materials (1.     Human-Spongiosa, gefriergetrocknet, CHB; 2. collacone®)   "
14980|NCT03089606|"     Explore association between intensity of C11-AMT PET at baseline, as measured by mean     standardized uptake value (SUVmax at each lesion), total tumor metabolic volume, measurement     of intra-tumoral and inter-lesional heterogeneity), with objective response rate (ORR) at 12     weeks (as defined via RECIST1.1) to pembrolizumab in patients with treatment-naïve metastatic     melanoma.   "
14981|NCT03089593|"     The main objective of the study is to evaluate the thermogenic effect of ginger.   "
14982|NCT03089580|"     This study will evaluate the efficacy of intense pulsed light (IPL) therapy for the treatment     of dry eye disease. One eye of the participant will be randomized to receive the IPL     treatment.   "
14983|NCT03089567|"     Comparison of the salivary levels of Streptococcus mutans in pediatric patients with Early     Childhood Caries after the application of Silver Diamine Fluoride or 5% Sodium Fluoride     Varnish   "
14984|NCT03089554|"     This is a substudy (Part 2) of a larger two-part clinical trial including both observational     and therapeutic (interventional) cohorts to assess the progression free survival ratio of     patients treated with a targeted therapy based on genomic analysis results and recommendation     by the Markey Cancer Center Molecular Tumor Board (MCC MTB).   "
14985|NCT03089541|"     This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/cigarette dual     users (15 males/15 females) will use smartphone-based ecological momentary assessment (EMA)     to gather real-time data of e-cigarette and cigarette behaviors during a 1-week     cigarette/e-cigarette dual use period and a 2-week exclusive e-cigarette use period.     Exclusive e- cigarette use will be promoted with contingency management (CM) procedures.(1)     Participants will respond to daily random prompts assessing in-the-moment use of     e-cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal)     and contextual factors (location, activity, social cues) associated with each episode of use.     Participants will also complete daily electronic diaries to document e-cigarette use     episodes/day, and satisfaction with the e-cigarette experience during the study.   "
14986|NCT03089528|"     The use of videolarygoscopy (VL) as first choice for tracheal intubation versus direct     laryngoscopy (DL) is a matter of debate.      These two methods were compared in several studies. Videolaryngoscopes may reduce the number     of failed intubations, particularly among patients presenting with a difficult airway. They     improve the glottic view and may reduce airway trauma. DM is accepted as a risk factor for     difficult intubation.      The aim of this study is to compare VL to DL in adult patients requiring tracheal intubation     for anesthesia, in terms of first-attempt intubation success, glottic view quality,     conversion to another laringoscopy method and adverse outcomes related to tracheal     intubation.   "
14987|NCT03089515|"     Many Survivors in the World Trade Center (WTC) clinical program have a clinical syndrome     characterized by chronic obstruction in small airways and persistence of lower respiratory     symptoms despite therapy. This study will test the hypothesis that persistent symptoms in WTC     Survivors are associated with abnormal small airways whose dysfunction is amplified during     exercise and is associated with biologic evidence of inflammation and remodeling. The results     from this study will have important treatment implications for our WTC population with     potential applicability to larger populations with either inhalational lung injury and/or     airway diseases such as asthma and chronic obstructive pulmonary disease.   "
15089|NCT03087968|"     This clinical investigation is a substudy within GS-US-416-2124, IND 129570, which is A Phase     2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of     GS-4997 in Combination with Prednisolone versus Prednisolone Alone in Subjects with Severe     Alcoholic Hepatitis. The use of the HepQuant SHUNT test is to assess liver disease severity     before, during, and after treatment with GS-4997 or placebo, to assess liver disease     severity.   "
14988|NCT03089502|"     Breast cancer is the leading cause of cancer among Canadian women with nearly 26,000 new     cases diagnosed each year. Fortunately, advancements in diagnostic tools and curative     treatments have significantly improved overall survival. However, the development of cardiac     toxicity (including asymptomatic and symptomatic heart failure) associated with use of     anthracycline containing chemotherapy and targeted therapies including trastuzumab limits     improvements in survival for women with breast cancer. Cardiac toxicity is a life threatening     complication that leads to reduced physical functioning and quality of life. The increased     risk is associated with shared risk factors among cancer and heart failure and the direct     influence of cancer therapy on the cardiovascular system. Cardiac rehabilitation (CR)     (including exercise training and education/counselling) has been shown to improve health     outcomes, reduce heart failure related hospitalizations and modestly improve mortality among     individuals with non-treatment related heart failure and may benefit women with breast cancer     and treatment related cardiac toxicity (BC-CT). Therefore, this single centre, randomized     control trial aims to determine if participation in an exercise based CR program can improve     cardiorespiratory fitness, cardiovascular function/structure and health, and quality of life     among women with BC-CT.   "
14989|NCT03089489|"     PGD is a syndrome characterized by alveolocapillary barrier structural and functional     alterations with surfactant inactivation and vascular permeability increase, which cause lung     edema, parenchymal infiltrate and progressive hypoxemia.      PGD may be enhanced in lung donor. Inflammatory and structural changes may be present in the     lungs before organ recovery and/or after organ preservation. The investigators aim to     identify the surfactant protein, inflammatory and structural changes in lung donor before and     after cold ischemia, and biomarkers to PGD in lung recipients.   "
14990|NCT03089476|"     It is hypothesized that food allergy is preceded by atopic dermatitis (AD), due to a     disruption of skin barrier which can predispose one to food sensitization through the skin.     The central hypothesis is that increased transepidermal water loss (TEWL) assessment and skin     tape strip analysis (STS) of lipid and filaggrin breakdown products will be predictive     markers for the development of AD. Additionally, the associated changes in TEWL and STS will     further improve the identification of infants at risk of early food sensitization, compared     to family history alone.   "
14991|NCT03089463|"     This observational cohort study aims to develop a novel risk stratification system     implementing biomechanics to aid in the prevention of diabetic foot ulcers.   "
14992|NCT03089450|"     to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)   "
14993|NCT03089437|"     The effects of 12 hours of prolonged standing will be compared to prolonged standing on a     high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be     measured in a crossover study design.   "
14994|NCT03089424|"     Photobiomodulation therapy (PBMT) is a non-pharmacological method commonly used in treatment     of musculoskeletal disorders. However, there are few high-quality scientific evidence to     support the effectiveness of this therapy in the treatment of patients with chronic low back     pain, at short, medium and long term. The present research project aims to evaluate the     effects of PBMT in patients with chronic non-specific low back pain.   "
14995|NCT03089411|"     Collection of retrospective additional data (survival, biological, disease response data)     following the study IFM 2013-04.   "
14996|NCT03089398|"     The purpose of the study is to learn which treatment option is better for patients who have     multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to     the heart muscle). The treatment options this study will compare are: (1) Hybrid Coronary     Revascularization [HCR] (a combination of surgery and catheter procedures to open up clogged     heart arteries) and (2) Percutaneous Coronary Intervention [PCI] (catheter procedures alone     to open up clogged heart arteries). There are no new or experimental procedures being     tested in this study: both HCR and PCI are well-established procedures and are regularly     performed in patients who have coronary artery disease. But, the FDA has not approved the     drug-eluting stents used in PCI for all types of coronary artery disease. We have received an     Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in     the same way that they are used in clinical practice. The study being proposed here will use     rigorous scientific methods and should result in a very high level of certainty about which     procedure is best for patients with coronary artery disease.   "
14997|NCT03089385|"     The objective of this project is to develop, validate, and implement a tool to help manager     hypertension in patients on hemodialysis.   "
14998|NCT03089372|"     The present study evaluates the efficacy and safety of repetitive treatments of Low Intensity     Extracorporeal Shock Wave Treatment (LI-ESWT) using Aries ED device in men with mild-moderate     and severe vasculogenic ED, who have previously responded to oral PDE5-Is, and completed 6 or     12 sessions of LI-ESWT with Aries device during the last 6 month.   "
14999|NCT03089359|"     This study evaluates the predictive value of soluvent urokinase plasminogen activator     receptor (suPAR) and lactate with respect to serious conditions among patients presenting to     the EMS with unspecific symptoms.   "
15000|NCT03089346|"     Bronchial remodeling is a major pathological feature of asthma. Non-invasive assessment of     this bronchial remodeling is a crucial issue for asthma patients' follow-up. Currently,     computed tomography (CT) is the method of reference to evaluate and quantify bronchial     thickness but it remains unable to differentiate bronchial inflammation from remodelling and     is a radiation-based technique. Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time     (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective     is to evaluate bronchial thickness in asthma patients using CT and MRI-UTE, and to test the     agreement between both techniques.   "
15001|NCT03089333|"     New strategies trying to achieve blood pressure control and consequently reduce     cardiovascular risk in resistant hypertensive subjects are promising. In this context, the     SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a     potential drug in order to impact on blood pressure levels, as well as target organ damage     and adiposity in this high-risk population.   "
15002|NCT03089320|"     The investigators plan to determine the effectiveness of contingency management (CM) plus     stepped care for unhealthy alcohol use in HIV-positive patients.   "
16756|NCT03066219|"     The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic     Solution to placebo for the treatment of the signs and symptoms of dry eye.   "
15006|NCT03089268|"     Different subtypes of serrated lesions have been recently described. Among them, both sessile     serrated polyp/adenoma (SSP/A) and traditional serrated adenoma (TSA) could have malignant     potential through the serrated pathway or CIMP. These lesions, as a potential source of     interval cancer, should also be considered in colorectal cancer (CRC) population-based     screening programs. It is believed that this new described pathway could be responsible for     up to 30% of all CRC.      Unlike the traditional adenoma, serrated lesions are difficult to diagnose because of their     particular endoscopic appearance and their still unclear histological criteria. Furthermore,     they have specific molecular changes and, through them, they could evolve into CRC faster     than the adenoma. The real prevalence of the serrated lesions and their specific risk for     developing new synchronous/metachronous lesions, or even malignancy, remains unknown. For all     these reasons, we don't know if these patients could constitute a different CRC-risk group     and if specific recommendations are needed during their follow-up.      This is a prospective longitudinal study developed within the framework of the CRC-screening     program in the Valencian Community (Spain). We expect to include a total of 700 individuals     who will be followed during 10 years.      In our study, we will collect epidemiologic variables related to the patient, variables     related to all the polyps, and mutational (BRAF, KRAS, MSI), and CpG-island methylation     status of serrated lesions. Strict endoscopic and histological criteria will be applied for     the diagnosis of serrated lesions. All lesions detected at the index colonoscopy and during     follow-up will be evaluated.      The purpose of this study is to correlate epidemiologic data, histological characteristics     and the molecular profile of the serrated lesions with findings during follow-up, in order to     define stratified groups according to their risk of developing new lesions or CRC in the     future.   "
15007|NCT03089255|"     Traumatic lesions are the leading causes of admission to the emergency center (39%), isolated     non-surgical lower limbs trauma are in the foreground. Two recent meta-analyzes suggest the     value of Low Molecular Weight Heparins (LMWH) which would reduce symptomatic Thromboembolism     Events (TE) in patients with lower limb trauma. However, many recent studies conclude to the     need of stratifying the TE risk according to the patient and the nature of his trauma to     obtain an individualized therapeutic decision.      The retrospectively established L-TRIP (cast) score allows stratification of the risk without     taking into account the type of trauma. The TIP score (Trauma, Immobilization and Patient)     was established by consensus of international experts via the Delphi method.      We suggest that the application of the TIP score to rationalize indications of     thromboprophylaxis in patients with isolated non-surgical trauma of a lower limb should     reduce the rate of anticoagulation prescription without increasing the risk of symptomatic     thromboembolic complications with a direct benefit for patients and medico-economic for the     society.   "
15008|NCT03089242|"     Profiling of microRNAs and long noncoding RNAs (lncRNAs) in patients undergoing cardiac     surgery. Analysis: Prediction of acute kidney injury by plasma expression profile of     microRNAs?   "
15009|NCT03089229|"     Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance     of epidermal-barrier function that results in intensely pruritic subacute and chronic     eczematous plaques. The current therapy of AD is reactive, where the flares are treated     through symptomatic management with topical corticosteroids and calcineurin inhibitors. Given     that these medications have long-term side-effects, and given the chronically relapsing     immunopathogenic nature of AD, there is an imperative need for safer anti-inflammatory     medications. Haus Bioceuticals (Haus) has developed a novel topical treatment for     eczema/atopic dermatitis (AD) denoted HAT01H, and have demonstrated that HAT01H is safe and     profoundly effective in the treatment of AD, controlling signs and symptoms in 85% of     patients with AD. This study is aimed to further test the efficacy and safety of topical     HAT01H in patients with moderate to severe atopic dermatitis.   "
15010|NCT03088995|"     The purpose of the OPDEP pilot study is to assess the feasibility of implementing a     pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and     refer for surgical intervention under general anesthesia in the Department of Stomatology of     the Pitié-salpêtrière hospital.      Patients undergoing treatment in Stomatology have particular areas at risk for the infections     we are looking for: young patients, precarious situation, drug use, migrants ...      The aim is to evaluate the conditions for a generalization of screening in the framework of     the preoperative assessment.   "
15011|NCT03088982|"     Background :The European General Practitioners Research Network (EGPRN) designed and     validated a comprehensive definition of multimorbidity using a systematic literature review     and qualitative research throughout Europe. This survey assessed which criteria in the EGPRN     concept of multimorbidity could detect decompensating patients in residential care within a     primary care cohort at a 6-month follow-up.      Method: Family Physicians included all multimorbid patients encountered in their residential     care homes from July to December 2014. Inclusion criteria were those of the EGPRN definition     of Multimorbidity. Exclusion criteria were patients under legal protection and those unable     to complete the 2-year follow-up. Decompensation was defined as the occurrence of death or     hospitalization for more than seven days. Statistical analysis was undertaken with uni- and     multivariate analysis at a 6-month follow-up using a combination of approaches including both     automatic classification and expert decision making. A Multiple Correspondence Analysis (MCA)     and a Hierarchical Clustering on Principal Components (HCPC) confirmed the consistency of the     results. Finally a logistic regression was performed in order to identify and quantify risk     factors for decompensation.   "
15012|NCT03088969|"     The back pain connected to the work stay a major problem in industrialized countries, in     particular because of the repercussions of this affection on the work (sick leave,     absenteeism, handicap and inaptitude). It is difficult to consider among all the patients     with a Chronic Low Back Pain in the work: how much they are going to stop. However,     Investigator can consider that approximately 20 % of the patients have a sick leave. Several     studies showed well that more the sick leave work stoppage goes on more the risk of not     resumption of work increases. Several risk factors were associated to the evolutionary     forecast of the pathology and thus to the extension extra time of the sick leave: individual,     environmental, psychosocial and organizational.      The evaluation of the self-efficiency perceived of return in the work of the patients by a     validated auto-questionnaire is thus an additional objective parameter determining the risk     factors of unfavorable evolution of the patients with Low Back Pain. This parameter also     allows highlight other levers of actions in the therapeutic education.   "
15090|NCT03087955|"     The goal of this study is to assess efficacy and safety of SCYX-7158 given as a single dose     oral treatment for adult patients (above or equal 15) in the fasting state with T.b.     Gambiense HAT   "
15091|NCT03087942|"     The aim of the study is to assess whether renal impairment could affect fevipiprant     pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient     population.      The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic     profile as the procedure might remove a significant fraction of the drug.   "
15013|NCT03088956|"     The objectives of the study are to; (1) estimate the change in disease -related cognitive     decline over 1 year on a battery of cognitive tests administered to participants with     early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic     variant; (2) identify the cognitive test or brief battery of cognitive tests which are the     most sensitive to detect bvFTD progression; (3) determine the optimal schedule of     administration of cognitive tests to detect bvFTD progression; (4) evaluate the relationship     between cognitive tests and measures of behavior, function, caregiver's burden, quality of     life (QOL); and (5) obtain blood samples for genetic and exploratory biomarkers correlations.   "
15014|NCT03088943|"     This project aims at exploring measures of diastolic function perioperatively.   "
15015|NCT03088930|"     This study will evaluate the efficacy of crizotinib as induction therapy in participants with     surgically resectable ALK rearrangement, ROS1 rearrangement, or MET exon 14 mutation positive     NSCLC.   "
15016|NCT03088917|"     Objective:      To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them     about there disease severity and treatment options.      Study design: This is a prospective cohort study, which will start as a pilot study in the     Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen.     This so-called lost population consists of all patients, that in the past have been     identified at the Radboudumc but who are currently lost to or have been withdrawn from     follow-up. The time-span of interest will be 2000-2015. We estimate that this project will     retrace 100 lost patients through this search.   "
15017|NCT03088904|"     The purpose of the study is to investigate and compare the cell responses to influenza     vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles     of genetics and environment in the response to flu vaccination.   "
15018|NCT03088891|"     Athletes, especially in endurance sports, are at increased risk of oxidative stress and     inflammation-related diseases and injuries. The production of reactive oxygen and nitrogen     species (RONS) and inflammatory markers increase during exercise and especially during     altitude training. Antioxidant supplementation is commonly used among athletes in the belief     that it prevents oxidative stress and oxidative damage. A transient increase of RONS is     however necessary to activate signaling cascades initiating training adaptation. Antioxidant     supplementation has been shown to inhibit the exercise effects in several independent     studies, possibly by interfering/reducing the signal cascades initiated by RONS. However, it     is unknown whether a high intake of antioxidant rich foods can affect the amount of RONS,     inflammation markers and/or training adaptation. The investigators want to examine whether an     increased intake of natural antioxidants in the form of antioxidant-rich foods fruits,     vegetables and berries, in line with the official Norwegian dietary advice can affect     antioxidant status, immune function and training adaptation associated with altitude training     in Norwegian elite athletes.   "
15019|NCT03088878|"     This is Phase 1b/2 study to investigate the safety and effectiveness of the investigational     drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid     malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR 1)     that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell     signaling that cause leukemia cells to grow and survive. ROR1 is rarely found on healthy     cells.   "
15020|NCT03088865|"     Implementation of the initial specimen diversion technique, in which the first milliliter of     the venipuncture sample is not injected into the culture bottle, led to a significant     reduction in blood culture contamination rates. This technique is based on the assumption     that the skin plug aspirated during venipuncture is a major source of contaminating bacteria.     One such diversion method is aspirating the first blood volume into a blood collection tube.     It has, however, been suggested that regular blood collection tubes carry contaminants from     the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination     rates. The aim of this trial is to examine the effect of aspirating the first blood volume     into a regular blood collection tube on blood culture contamination rate.   "
15021|NCT03088852|"     Hypomagnesemia is a common entity in the inpatient and outpatient setting. in previous     retrospective study hypomagnesemic patients have higher mortality and longer hospitalization.     whether hypomagnesemia is merely a marker of poor prognosis, or whether replacing it can     improve outcomes is unclear. The current standard of care is to discharge these patients     without workup or further treatment, even if patients had received intravenous therapy while     hospitalized. The investigator wish to examine prospectively whether giving replacement     therapy affects mortality, length of hospital stay and overall well-being. In order to     replete intracellular levels and replete magnesium stores, magnesium should be given for     several months.   "
15022|NCT03088839|"     Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases     per 100,000 individuals/year and it is characterized by progressive neurodegeneration of     motor neurons. When motor neurons degenerate the ability of the brain to initiate and control     muscle movement is lost. ALS manifests in two forms: Familiar ALS (FALS) with inherited risk     genotypes, accounts for only 10% of cases and sporadic ALS (SALS) without apparent     heritability accounts for 90% of cases. ALS can occur in both female and male subjects at any     age but is more common in people aged over 40.      Although the molecular mechanism underlying the pathogenesis of ALS is still under     investigation, recent research has revealed that diseases affecting motor neurons may be     associated to alterations of RNA metabolism and biogenesis of small non-coding micro RNAs     (miRNAs). miRNAs are circulating molecules, whose expression profiles are widely described to     have an important potential in monitoring the progression of a disease, to promote the     development of more targeted therapies and/or to determine the effectiveness of treatments.     Altered patterns of specific miRNAs expression have been described in several pathological     conditions. Evidence shows a significant reduction in the levels of certain miRNAs also in     patients with ALS. Among others, miRNA-218 has been described to play a critical role in the     onset of motor neurons differentiation and in establishing cell identity and fate.      Changes in the levels of miRNA-218 in the serum of ALS patients may potentially provide     useful tools to determine the possible association with this disease and to candidate it as     indicator of disease progression.   "
24121|NCT02969928|"     The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement     combined with clarithromycin or amoxicillin + metronidazole association for the treatment of     generalized aggressive periodontitis (GAgP).   "
15023|NCT03088826|"     Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency     department and in outpatient settings. Both medications have a very high potential for abuse     due to the prominence of the euphoric effect (abuse liability) and relative lack of bad or     negative effects (likeability). The highly addictive properties of these medications lead     to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse,     development of dependence and addiction, and, most importantly, death due to overdose. In     contrast, several research papers demonstrated that administration of MSIR results in similar     analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and     rewarding associated effects. In addition, consumption of large doses of MSIR leads to     dysphoria, vomiting and sedation (negative effects). To the investigators' knowledge, there     are no randomized controlled trials in the ED that directly compared analgesic efficacy of     MSIR to Percocet   "
15024|NCT03088813|"     This is an open-label phase 3 comparative study to assess the safety, tolerability, and     efficacy of irinotecan liposome injection compared to topotecan (IV) in patients with small     cell lung cancer who have progressed on or after platinum-based first-line therapy.      The study will be conducted in two parts:      1a. dose determination of irinotecan liposome injection      1b. preliminary safety and efficacy      2. a randomized, efficacy study of irinotecan liposome injection versus topotecan   "
15025|NCT03088800|"     Current literature supports ibuprofen and APAP are the most commonly used analgesics in the     pediatric ED for acute mild to moderate traumatic/non-traumatic pain. However, the analgesic     benefits of combination ibuprofen and APAP in this specific setting does not exist, but     instead only as it applies to pediatric patients with postoperative pain. Thus, we have     designed a double-blind, randomized, controlled clinical trial to evaluate analgesic     efficacy, safety and feasibility of combination therapy to potentially broaden its clinical     application in the pediatric ED. The investigators' hypothesize that combination oral     ibuprofen and APAP therapy is superior to either drug alone and is an excellent analgesic     modality for controlling acute mild to moderate traumatic/non-traumatic pain in the pediatric     ED.   "
15026|NCT03088787|"     The primary purpose of this study is electronic data collection of arterial pressure waveform     signals in patients with Aortic Stenosis. The collected digital pressure waveform data will     be used to assess the feasibility of using the arterial pressure signal as a decision support     tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic     parameters before and after valve repair and its correlation with outcome.   "
15027|NCT03088774|"     This project studies the effects of involving patients in the development of a     web-application.   "
15028|NCT03088761|"     The changes in the cuff pressure in the absence of nitrous oxide are less clear.In the     current study, we aim to determine the changes in cuff pressure over time in infants     undergoing myelomeningocele repair in prone position under general anesthesia in the absence     of N2O.   "
15029|NCT03088748|"     The purpose of the study is to acquire kinematic in vivo fluoroscopy data using the     University of Tennessee's tracking fluoroscopy system (TFS) from subjects who were implanted     with the Smith & Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty     (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for     the Smith & Nephew BCS TKA and compared these kinematics data to those of normal knees.   "
15030|NCT03088735|"     It has been previously shown that although the activation of the embryonic genome can begin     as early as two days of initiation of the embryonic development (D2), it is expressed on day     3 (D3). Without this activation, the embryo can not continue its development. Therefore, it     has been suggested that extended culture to blastocyst stage could be an option to identify     and better select embryos that have been able to carry out this activation. The purpose of     this study is to compare cumulative pregnancy and live birth rates following transfer of     cleavage embryos or blastocysts.   "
15031|NCT03088722|"     This proposed study, to be run by Marie Stopes International Organisation Nigeria (MSION)     will investigate whether Community Health Extension Workers (CHEWs) in Nigeria can insert and     remove contraceptive implants to the same level of safety and quality as a nurse or midwife,     and whether this is acceptable to their clients and colleagues. The study will also document     feasibility issues which would be relevant to any future national programmatic scale-up.   "
15032|NCT03088709|"     Historically, the best results of allogeneic SCT have been obtained when the stem cell donor     is a human leukocyte antigen (HLA)-matched sibling, however, this is only available for     approximately 30 percent of patients in need for SCT. Alternative donor sources include     matched unrelated donor utilizing the donor registry, cord blood transplant and mismatched     donor transplant. A human leukocyte antigen (HLA)-haploidentical donor is one who shares, by     common inheritance, exactly one HLA haplotype with the recipient, and includes the biologic     parents, biologic children and full or half siblings. There is strong body of evidence     supporting the use of haplo-SCT in patient who lack a matched sibling or unrelated donor with     high rates of successful engraftment, effective Graft Versus Host Disease (GVHD) control and     favorable outcomes comparative to those seen using other allograft sources, including     HLA-matched sibling SCT. Furthermore, it provides a cost-efficient donor option in a timely     manner especially for patients who need to proceed quickly to transplant due to concern of     disease relapse/progression.   "
15033|NCT03088696|"     Assessment of the effectiveness of PC 6 Neiguan with conventional acupuncture for     preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.   "
15034|NCT03088683|"     In Laparoscopic Sleeve Gastrectomy, retraction of the left lobe of the liver is important for     an effective visualisation. There are many retractors available for this retraction. A study     is designed to compare two different liver retractors for liver trauma; Nathanson liver     retractor that is used more commonly and Reveel liver retractor that has more recent history     of use.   "
15035|NCT03088670|"     To demonstrate that efficacy of Gosogliptin as Monotherapy and in Combination with Metformin     is non-inferior to efficacy of Vildagliptin as Monotherapy and in combination with Metformin     in the effects on glycosilated hemoglobin (HbA1c) at Week 12 and Week 36 compared to baseline     (Week 0).   "
15036|NCT03088657|"     The Mood Disorder Cohort Research Consortium (MDCRC) study is designed as a naturalistic     observational prospective cohort study for early-onset mood disorders (major depressive     disorders, bipolar disorders type 1 and 2) in South Korea.   "
15037|NCT03088644|"     The primary purpose of this study is to measure the whole body distribution and radiation     dosimetry of 18F-JNJ-64413739 (Part A), to measure the uptake, distribution, and clearance     (CL) of 18F-JNJ-64413739 in the brain of healthy male subjects by Positron Emission     Tomography (PET) and to model tissue specific kinetics of 18F-JNJ-64413739 with the     appropriate input function (IF) (Part B), to measure subject test retest variability in the     distribution of 18F-JNJ-64413739 in the brain of healthy male subjects by comparing PET scans     obtained at least 1 week apart (Part C) and following single oral dose administration of     JNJ-54175446, to measure the blocking of 18F-JNJ-64413739 uptake in the brain at the time to     reach maximum plasma concentration (tmax) of JNJ-54175446 and model the exposure/receptor     interaction of JNJ-54175446 in healthy male subjects (Part D).   "
15038|NCT03088631|"     The relationship between serum progesterone level on the day of human chorionic gonadotropin     administration and outcome of in vitro fertilization /intracytoplasmic sperm injection and     embryo transfer has been controversial for several decades. some studies presented data     against the negative effect of premature luteinization and reported that elevated serum     progesterone had no adverse effect on pregnancy rates in fresh embryo-transfer cycles within     different ovarian responses.However,most studies have evaluated the association between serum     progesterone level and clinical outcome in fresh in vitro fertilization /intracytoplasmic     sperm injection cycles, and advocated that serum progesterone elevation on the day of human     chorionic gonadotropin administration may adversely affect clinical outcome by jeopardizing     endometrial receptivity.      In addition, the underlying mechanism through which premature luteinization influences     clinical outcomes is elusive. some proposed that premature luteinization cause impairment of     the endometrial receptivity, which may indicate a change in the implantation window, is more     likely to be affected than the oocyte.whereas some documented that the compromised quality of     oocytes might also be a cause.      The cut off point of premature luteinization is not well established till now. Premature     luteinization has been variously defined based on serum P levels, with thresholds of 0.9-1.5     ng/mL being used.      Previous studies have shown that metformin inhibits the first steps of steroidogenesis dose     dependently reducing granulosa cells progesterone output .Moreover other authors have     recently reported that low dose metformin could improve in vitro fertilization outcome in non     poly-cystic ovarian syndrome repeaters.So,considering the safety of this drug before     pregnancy, metformin can be given to consenting patients from first ultrasound monitoring     until ovulation triggering.   "
15039|NCT03088618|"     The purpose of this clinical trial is to evaluate safety and efficacy of TnR mesh for     patients who need nasal septoplasty for septal deformity with nasal obstruction.   "
15040|NCT03088605|"     In subjects with Dry Eye Syndrome:      The primary objective of this study is to compare the safety and tolerability of TOP1630     Ophthalmic Solution to placebo.      The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to     placebo for the treatment of the signs and symptoms of dry eye syndrome.   "
15041|NCT03088592|"     The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery     (DBS) are not completely understood. The recording data that is used routinely as part of the     procedure to map the target structures, however, may be analyzed in order to better     understand the neural network dynamics in PD. The purpose of the study is to perform     simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus [STN]     or globus pallidus internus [GPi]) and the cerebral cortex. These simultaneous recordings may     provide insight in the pathology of PD and the mechanism of DBS. The researchers will also     study the effects of anesthesia level on neuron synchronization . Recordings with micro-ECoG     grid electrodes in the cortex show improved spatial resolution and these will be used to gain     better understanding of cortical network dynamics and the synchronization with subcortical     structures.   "
15042|NCT03088579|"     The researchers recognized the possible clinical usefulness of a shielded device or jig to     help increase the accuracy but decrease the time of loading the seeds into the biocompatible     material used intra-operatively. Therefore, the researchers created a prototype of a device     called the GammaTile (GT) loader (design patent pending). The reusable device will be made of     surgical quality stainless steel of sufficient thickness (greater than 10 half-value layers     (HVL) to provide significant staff and user shielding as well as allowing it to be     sterilized. It is utilized intraoperatively but off of the operative field and has no direct     patient contact. Currently two sizes are planned. The first will accommodate a 2 inch x 2     inch collagen square and the second will accommodate a 1 inch x 1 inch collagen square. These     are the most commonly used sizes of lyophilized collagen used in the Barrow Neurosurgical     Institute (BNI) operating rooms (OR).   "
15043|NCT03088566|"     Early identification of potential risk factors for the onset of diabetic foot ulcers are     recommended. However, in a Swedish context, there has been no standardised routines to be     used in the foot screening procedure. In this study a new standardised routine, the D-Foot,     will be tested at the Department of Prosthetics and Orthotics. The usability of the web     program will be tested.   "
15044|NCT03088553|"     This study aims to better define the target range of ganciclovir trough concentrations by     investigating the relationship between ganciclovir concentration and the time to undetectable     CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.   "
15045|NCT03088540|"     To assess the safety and efficacy of REGN2810 as first-line treatment in patients with     advanced or metastatic NSCLC whose tumors express PD-L1.   "
15046|NCT03088527|"     The primary purpose of this study is to evaluate the clinical safety profile, tolerability,     and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast     cancer.   "
15047|NCT03088514|"     This study aims to determine whether dietary inorganic nitrate (in beetroot juice) is able to     reduce overall thickening of the heart (left ventricular hypertrophy or LVH) and stiffness of     the arteries when given to patients with persistently raised blood pressure (hypertension).     Half the patients will receive the beetroot juice containing inorganic nitrate and half will     receive beetroot juice from which the inorganic nitrate has been removed. The volunteers will     take the juice every day for 4 months.   "
15048|NCT03088501|"     MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of     Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the     effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in     predicting the possible risk markers of later chronic diseases. The recruitment of the     pregnant women in MAASTHI has begun in the month of April 2016.The current strategy deployed     in MAASTHI cohort is to follow up pregnant women at birth and in-person child assessments     annually during the year 1, 2, 3 and 4 of the child. Despite stringent adherence of including     only the residents of the source population, nearly 13% of the women were lost to follow-ups     at birth. In order to prevent further loss to follow-ups in subsequent visits, the     investigators aim to explore whether interventions involving innovative IVR and conducting     mother and baby workshops can improve follow-up rates.   "
15049|NCT03088488|"     Vitamin D has become important for periodontal disease due to play a role in autoimmunity,     bone mineral metabolism and inflammation. Our aim was to investigate the relation between     serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum     biomarkers. The subjects were evaluated in 2 groups as chronic periodontitis (n= 30) and     periodontally healthy subjects (n= 30). Periodontal parameters and fasting venous blood     samples were taken from the subjects to assess each patient's periodontal status and for     biochemical analyses (25-hydroxy vitamin D (25-OH vit D), osteoprotegerin (OPG), receptor     activator of nuclear kappa B ligand (RANKL), C-telopeptide (CTx), tumor necrosis factor-α     (TNF-α)).   "
15050|NCT03088475|"     Aim. To develop and compare a nurse-led smartphone-based self-management programme with an     existing nurse-led diabetes service on health-related outcomes of type 2 diabetes patients     with poor glycaemic control in Singapore.      Background. Over the past decades, Asia has emerged as the 'diabetes epicentre' in the world     due to rapid economic development, urbanisation, and nutrition transition. There is an urgent     need to develop more effective care management strategies in response to this rising diabetes     epidemic.      Design. A randomised controlled trial with pre- and repeated post-tests control group design.      Methodology. A total of 128 type 2 diabetes patients with poor glycaemic control will be     recruited from the diabetes clinic of a public acute hospital in Singapore through     convenience sampling. Study participants will be randomly allocated either to the     experimental group or the control group. Outcome measures will include the 10-item General     Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities, and 19-item     Diabetes-Dependent Quality of Life. Data will be collected at three time points: baseline, 3     months, and 6 months from the baseline.      Discussion. It is expected that this programme will be an alternative offered to diabetes     patients to master their self-care management skills, in addition to the existing diabetes     service provided in diabetes clinics in Singapore hospitals. Furthermore, the self-supporting     and less resource-intensive nature of this programme, through the use of a smartphone     application as the mode of intervention delivery, will greatly reduce nurses' direct contact     time with patients and allow more time to be allocated to those who require more attention.   "
15051|NCT03088462|"     LiveWell is a study evaluating the use of smartphones to better understand and improve the     treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions     and improve their effectiveness in reducing symptoms and preventing mood episodes.   "
15052|NCT03088449|"     To develop a cost-effective, individualised anti-TNF treatment strategy for patients with     Crohn's disease which maximizes benefit and minimises harm.      The primary objective of this study is to investigate the mechanisms that underlie primary     non-response (PNR), loss of response (LOR) and adverse drug reactions (ADRs) to anti-TNF     drugs in patients with active luminal Crohn's disease.   "
15053|NCT03088436|"     The aim of the present study was to determine the prone-to-supine displacement of breast     lesions using preoperative prone MRI and supine second-look ultrasound data   "
15054|NCT03088423|"     The aim of this work was to describe SBRT different presentations, to study predictive     factors for tumor responses following treatment, and to compare tumor response assessments     according to the Response Evaluation Criteria   "
15055|NCT03088410|"     The purpose of this study is to assess the early longitudinal metabolic effects including     insulin sensitivity in HIV-exposed uninfected (HEU) children compared to HIV-unexposed     uninfected (HUU) children; as well as to determine differences in the effects of neonatal     zidovudine (AZT) vs. nevirapine (NVP) prophylaxis on early longitudinal changes in insulin     sensitivity in the first 3 years of life.   "
15057|NCT03088384|"     Klarisana is conducting an observational study in San Antonio, Texas to see if there are     tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat     veterans after receiving a series of six low-dose outpatient infusions of ketamine.   "
15058|NCT03088371|"     Objectives: To compare the efficacy of continuous combined psoas sciatic block as a sole     anaesthetic technique with conventional combined spinal epidural anesthesia for patients     undergoing total knee arthroplasty.      Subjects and Method: Eighty patients ASA (American society of anaesthesiologists     classification) I to III with age range from 50 to 65 years old and scheduled for total knee     replacement were included in the study. Subjects were divided into two groups; the first     group (Pso/sci) received ultrasound guided with the use of nerve locator continuous psoas     sciatic block and the second group (CSE) received combined spinal epidural anesthesia. Onset     of sensory and motor block time, hemodynamic changes, contra-lateral spread, first time need     for analgesia, incidence of complications, and patient and surgeon satisfactions were     recorded.   "
15059|NCT03088358|"     To evaluate influence of therapy on the following efficacy and safety parameters in different     TeaRx dose groups and Enoxaparin group:        -  Total venous thromboembolic events (VTE), which includes confirmed deep venous          thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality        -  Incidence of DVT (total, proximal, distal)        -  Incidence of nonfatal PE        -  Incidence of symptomatic VTE (DVT, PE)        -  VTE caused mortality        -  Non-VTE caused mortality        -  Incidence of all hemorrhagic complications        -  Incidence of major and clinically relevant non-major bleeding        -  Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical          examination, vital signs, laboratory results   "
15060|NCT03088345|"     This is an investigator initiated, prospective, single-center, double-blinded, randomized,     placebo-controlled trial of post-operative low dose vasopressin infusions as an early     treatment of low systemic perfusion in pediatric patients following Fontan palliation.   "
15171|NCT03087032|"     The present 24-week, prospective, open-label, randomized, multicenter, parallel group trial     is carried to investigate and evaluate the effectiveness and safety of adding Liraglutide vs     insulin Glargine to prandial insulin in type 2 diabetes patients treated with premixed     Insulin.   "
15092|NCT03087929|"     A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High     Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and     Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012. The primary     objectives of this previous trial was to assess progression free survival and overall     survival. Of the 36 patients in this trial, approximately 18 remain in remission. In this new     follow up trial, follow up data will prospectively be collected on patients who provide     informed consent to do so.   "
15061|NCT03088332|"     Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around     the world in recent years. Treatment for patients with class III or class II obesity with     comorbidities is already well established, with bariatric surgery being the best option.     However, there is no consensus as to the best treatment for cases of class I and class II     obesity without comorbidities. The objective of this research will be to make a gastric tube     similar to that obtained in surgical gastroplication however it will be created using     intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of     the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same     location.   "
15062|NCT03088319|"     The risk of emergence of a post natal depression is based on an interaction between a     maternal psychic vulnerability and a chronic environmental context of stress. The PND appears     as a relevant model for studying the mechanisms of chronic stress and vulnerability to     psychological pathologies.      This study aim to follow a cohort of pregnant women to determine the predictive     psychobiological factors of the emergence of postnatal depression   "
15063|NCT03088306|"     Patients presenting for lumbar spine surgery experience pain related to their spine     condition. Following surgery, these patients also experience surgical pain resulting from     disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. This     pain is often treated with opioid medications - with roughly 40% of patient experiencing     sub-optimal pain management. Adequate pain control has become a top priority among     professional societies, healthcare systems, and accrediting agencies. The current proposal     will provide this critical evidence of feasibility and acceptability of a multi-modal pain     management plan for patients undergoing lumbar spine surgery. Additionally, this study will     provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal     pain management to control post-operative pain, reduce opioid medication use, and improve     physical activity, sleep, and health.   "
15064|NCT03088293|"     This study will evaluate the Efficacy and Safety of Infliximab versus Cyclophosphamide in     Subjects with Idiopathic Refractory Scleritis.      The term scleritis describes a chronic inflammation that involves the outermost cost and     skeleton of the eye. Scleritis is classified anatomically as either anterior or posterior     based on the principal location of the inflammation. Thirty to forty percent of scleritis     cases are associated with systemic autoimmune conditions including rheumatoid arthritis and     granulomatosis with polyangiitis. Infectious causes including herpes virus and varicella     zoster account for 5 to 10% of patients. The remaining 50% of cases are classified as     idiopathic.      CIRIS, is the first prospective randomized, head to head study, comparing infliximab to     cyclophosphamide in refractory idiopathic scleritis. There is no firm evidence or randomized     controlled trials directly addressing the best biologic agent in severe and refractory     idiopathic scleritis. If left untreated or insufficiently treated, scleritis can progress to     peripheral ulcerative keratitis, uveitis and glaucoma. Visual loss occurs in approximately     10% of patients with anterior scleritis and in up to 75% of patients with posterior     scleritis. The incidence of burden in ocular inflammation (uveitis and scleritis) has been     dramatically reduced in the recent years with the use of biologics, raising the question of     whether these compounds should be used earlier in the treatment of severe non infectious     scleritis. Contrasting with other immunosuppressors, cyclophosphamide and infliximab act     rapidly and are highly effective in steroid's sparing.      Despite a strong rationale, these compounds are not yet approved in idiopathic refractory     scleritis, which guarantees the innovative nature of this study that aims selecting or     dropping any arm when evidence of efficacy already exists.   "
15065|NCT03088280|"     Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year     efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk     patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.   "
15066|NCT03088267|"     This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover     study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of     ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.   "
15067|NCT03088254|"     To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in     subjects with dyslipidemia with hypertension.   "
15068|NCT03088241|"     This trial addresses the question of the viral load (VL) threshold for switching from     first-line to second-line antiretroviral therapy (ART). The WHO currently sets the threshold     at 1000 copies/mL. However, the optimal threshold for defining virological failure and the     need to switch ART regimen has not been determined. In fact, people with VL levels of less     than 1000 copies/mL, however, not fully suppressed, are at increased risk for drug resistance     mutations (DRM) and subsequent virological failure. In resource-limited settings where VL     monitoring is not as frequent as in high-income countries, this could have serious     implications and patients may continue on a failing regimen for a long period. Our research     consortium will conduct a multicenter, parallel-group, open-label, randomized clinical trial     in a resource-limited setting to assess whether a threshold of 100 copies/mL compared to the     WHO-defined threshold of 1000 copies/mL for switching to second-line ART among unsuppressed     HIV-positive patients on first-line ART will lead to better outcomes.   "
15069|NCT03088228|"     Background: To evaluate the association between maternal periodontal status and preeclampsia,     as well as the correlation of these two disorders with maternal gingival crevicular fluid     levels of interleukin (IL)-6, interleukin-35 (IL-35) and interleukin-37 (IL-37). The     investigators also investigated their relation to the severity of preeclampsia.      Methods: Twenty-nine healthy pregnant, 30 mild preeclamptic and 23 severe preeclamptic women     were recruited to the study. All of the periodontological measurements and gingival     crevicular fluid samples were obtained in the first day of puerperium during hospitalization.     The obstetric and neonatal outcomes of the patients were retrieved from the medical records.   "
15070|NCT03088215|"     Fibromyalgia pain syndrome is a common debilitating condition which associates mainly     generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no     specific treatment exists so far.      Lately, shock-waves have been used successfully to treat painful skeletal muscle, tendons and     fascia, the investigators therefore hypothesize that shock-waves could be useful in     alleviating Fibromyalgia pain.      Two similar groups of participants bearing the condition will be prospectively compared.      The first group will benefit from the application of shock-waves weekly for 12 weeks, the     second will not.      The investigators intend to study if there is any difference in pain and quality of life     between the two groups at the end of the three months.   "
15104|NCT03086720|"     This study will verify the effect of the application of a substance (10% sodium hypoclorite     -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of     the restorations performed in this type of lesion.      The hypothesis of the present study is that the application of deproteinization solution     after acid etching does not influence the failure rate of the restorations.   "
15071|NCT03088202|"     A major concern in today's oncology is the complexity of treatment that increases costs. A     main contributor is the increasing use of chemo- and radiotherapy during end of life (EoL:     the last 12 months of life). Importantly, intensive chemotherapy in EoL has uncertain     efficacy, may result in frequent hospitalizations and less time spent at home. Also, patients     with incurable disease who receive intensive treatment at EoL have worse quality of life     (QoL). A systematic palliative care (PC) approach that focuses on optimal symptom management     and maintenance of QoL of patients and family is often introduced too late in the disease     trajectory. Studies indicate that early introduction of PC in patients with unfavorable     prognosis may improve QoL and other symptoms and prolong survival. These and related findings     have made international stakeholders advocate a stronger integration of oncology and PC for     patients with incurable cancer.      The present project is a national multicenter cluster-randomized trial (RCT) in 12 oncology     departments in all 4 Norwegian health regions. The project tests the efficacy of a complex     tripod intervention that integrates oncology and PC for cancer patients with a     life-expectancy <12 months who receive chemotherapy and includes: A) systematic electronic     assessment of symptoms, B) implementation of standardized care pathways and C) an education     program for oncologists/PC physicians. The PC pathway focuses on the patient's journey     through the PC trajectory including EoL care in order to improve quality of care and reduce     the variability in clinical practice and costs. The intervention aims at empowering     physicians, patients and relatives and promoting shared-decision-making.   "
15072|NCT03088189|"     Maternal nutrition is an important factor which determines fetal growth and development.     Micronutrients vitamin B12 and folic acid are essential determinants of one carbon metabolism     and play an important role in DNA synthesis, methylation and epigenetic regulation of gene     expression. Diabetes unit of KEMHRC, Pune has been conducting the Pune Rural Intervention in     Young Adolescents since last 3 years. Subjects of the PMNS cohort have been randomized as     part of a controlled trial of nutritional intervention with vitamin B12 vs multiple     micronutrient and milk protein vs placebo. This study aims to understand the     intergenerational effects of vitamin B12 supplementation. 74 infants have been born in this     trial since 2013. This study would assess neurocognitive development of offspring born to     mothers who are part of the nutritional intervention trial; on the Bayley scales of infant     and toddler development - III. The study aims to test the hypothesis that infants born to     mothers who received vitamin B12 would have favorable infant neurocognitive development     scores as compared to placebo. And this effect would be enhanced in the group whose mothers     received MMN with milk protein.   "
15073|NCT03088176|"     The purpose of the study is to determine safety and tolerability of the combination of     talimogene laherparepvec in combination with dabrafenib and trametinib in BRAF mutated     advanced melanoma.   "
15074|NCT03088163|"     The study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance     imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal     cancer.   "
15075|NCT03088150|"     The primary objective is to prove non-inferiority of thermal ablation compared to hepatic     resection in patients with at least one resectable and ablatable colorectal liver metastases     (≤3cm) and no extrahepatic disease.   "
15076|NCT03088137|"     The purpose of this study is to show equivalence with regard to the number of oocytes     retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing     IVF/ICSI   "
15077|NCT03088124|"     Many prostate cancer are slow or non progressive forms that would never impair quality or     quantity of like of life if undetected. For this localized prostate cancer, the     recommendation is an active surveillance, however often experienced by the patient as a lack     of care. Thus the introduction of new potent androgen receptor inhibitor raise the question     of the benefit of early hormonal therapy in localized prostate cancers.      The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor     could influence the progression of localized prostate cancer and delay the time to local     treatment initiation.   "
15078|NCT03088111|"     This field study is a post-marketing requirement from the FDA to evaluate the clinical     benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab     administered to patients as part of their medical care for treatment or prophylaxis of     inhalational anthrax infection following exposure to Bacillus anthracis (B. anthracis). The     protocol can be implemented for any individual who receives obiltoxaximab for a suspected,     probable, or confirmed case of inhalational anthrax due to B. anthracis in the United States,     including sporadic cases, small incidents and/or a mass event. In case of a small anthrax     incident, to the extent possible, the information will be collected prospectively at     prespecified time points, except where it would interfere with management of the subject's     illness. However, because of the logistical complexities that would likely accompany a mass     anthrax event, most data in this study are anticipated to be collected retrospectively. Both     retrospective and prospective data collection are allowed to maximize information collection.     This study will collect data on the use of obiltoxaximab in anthrax infected or exposed     subjects and the data collected will inform the understanding of the clinical benefit and     safety of obiltoxaximab.   "
15087|NCT03087994|"     The proposed study is a randomized, open, comparative research involving an intervention     group and two control groups.      The aims of the study are: 1.To compare levels of depression in female adolescents with     obesity and a control group of female adolescents with appropriate weight and height. 2. To     investigate whether a decrease in weight due to a short range intervention program provided     by dietician for female adolescents with obesity will lead to change in the levels of     symptoms of depression and cognitive and executive functions in comparison to a control group     of adolescent girls with obesity, matched in age that does not receive such an intervention     program.      60 Female adolescents with obesity will be recruited to the study and will be randomized to 1     of two groups- 1. intervention group- participants in this group will attend an intervention     program consisting of 12 meetings with dietician and will attend three study visits at the     clinic- in the beginning of the study, after three months and at the end of the study after a     year. 2.Control group- Participants in this group will only come to three study visits at the     clinic. In the first two visits they will meet with a dietician and will receive nutrition     guidance and hypo-caloric menu.      Another 30 girls with appropriate weight will be recruited to second control group- this     group will come to three study visits at the clinic- in the beginning of the study, after     three months and at the end of the study after a year. In the first two visits participants     will receive nutrition guidance by the dietician.      In the study visits the following procedures will be performed for all study groups: Blood     tests, completion of psychological and nutritional questionnaires, completion of computerized     tests and measurements of height, weight, fat mass and circumference of hips.   "
15088|NCT03087981|"     The PANDA trial is a multicenter prospective observational study designed to analyze various     ICP derived parameters and clinical status in neurosurgical critical patients through a new     big data acquisition system.   "
31487|NCT02873624|"     The aim of this study is to establish AKI incidence in patients who are undergoing     laparoscopic cholecystectomy and to identify the potential risk factors associated with the     development of AKI.   "
15079|NCT03088098|"     Study category and Rationale Clinical study, Category A.      Clinical Phase: Post market study      Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral     anticoagulation and provides at the same time an at least equally good protection from     strokes and peripheral embolism. It may therefore be an attractive alternative to oral     anticoagulation in the patient population undergoing transcatheter aortic valve implantation     (TAVI): the concept of LAAO is based on the fact that thrombus formation in atrial     fibrillation occurs in >90% in the left atrial appendage (LAA). Mechanical occlusion of the     LAA reduces the stroke risk by eliminating the source of thrombus formation. In the here     proposed Randomized Comparison of Left Atrial Appendage Occlusion versus Standard Medical     Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve     Implantation, study we test the hypothesis, that LAAO is superior to standard medical     therapy in the high-risk TAVI population. This hypothesis has not been investigated by     previous studies so far.      Overall Objective(s): Overall objective: to compare the safety (and efficacy) of LAAO using     the St. Jude left atrial appendage closure device with standard medical therapy in a     prospective, multi-center, randomized trial in patients undergoing TAVI in routine clinical     practice.      Primary Objective: To assess the safety of the device intervention with regard to stroke     prevention and prevention of bleeding complications in a patients population at high risk of     stroke and bleeding.      Secondary Objectives: Short-term (procedural) safety of device intervention is assessed (rate     of successful deployment of a left atrial appendage occluder; rate of kidney failure). As a     further secondary objective, long-term effects of device intervention on stroke and bleeding     prevention as well as mortality are assessed and compared to medical therapy.      Outcome(s): Primary: Composite endpoint of ischemic and hemorrhagic neurologic events,     peripheral embolism, life-threatening/disabling and major bleeding complications and     cardiovascular mortality at 1 year      Secondary: All deaths (cardiac and non-cardiac) at 30 days, 1, 3, and 5 years Device success     at 30 days      In-hospital acute kidney injury (AKI)      Study design: An investigator-initiated, randomized, multicenter, non-blinded, all-comers     study      Measurements and Procedures: 80 patients in atrial fibrillation undergoing TAVI will be     randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or SMT at the     operators' discretion (medical group; antiplatelet therapy and oral anticoagulation or oral     anticoagulation alone). All patients will be followed for up to 5 years. The primary analysis     will be performed at 30 days and after completion of a 1-year follow-up.      80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded     fashion (1:1 randomization) to LAAO (device group) or standard medical therapy (SMT) at the     operators' discretion (medical group; antiplatelet therapy, oral anticoagulation or oral     anticoagulation alone).      Estimated duration for the main investigational plan from start of screening of first     participant to last participant processed and finishing the study: 6 years   "
15080|NCT03088085|"     This project aims to study the impacts of self-thoracic spine and rib mobilization on sleep     quality in patients who present to UTSW physicians with shoulder pain. The investigators plan     to randomize participants into treatment and control groups, but the investigators will     provide education on sleep hygiene for each group. The treatment group will also receive     instruction to mobilize their thoracic spine and ribs each night before going to sleep.   "
15081|NCT03088072|"     This is a single arm, open label, single site study assessing the feasibility of     post-procedural edoxaban therapy in atrial fibrillation (AF) patients after clinically     indicated WATCHMAN left atrial appendage (LAA) closure.   "
15082|NCT03088059|"     This is a biomarker-driven trial that will enroll patients with recurrent or metastatic     squamous cell carcinoma of the head and neck progressing after first-line platinum-based     chemotherapy. Based on potential biomarkers and molecular alterations identified in the     biopsy from the central platform, patients will be allocated in different cohorts. There will     be biomarker-positive patient cohorts and immunotherapy cohorts.   "
15083|NCT03088046|"     Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS)     involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP),     which are generally used to establish the presence of hyperandrogenemia. In general, these     levels are obtained during the follicular phase to maintain sampling uniformity and avoid     spurious increases due to corpus luteum function. However, because most hyperandrogenic     patients are oligo/amenorrheic, it is frequently necessary to administer a progestogen to     induce withdrawal bleeding and properly time the blood sampling.      Several medications have been described to properly induce withdrawal bleeding , with     medroxyprogesterone acetate (MPA) being the most widely use. However, synthetic compounds as     MPA do not replicate precisely the constellation of biologic activities of the parent hormone     and results in a temporary, albeit clinically relevant, suppression in ovarian function and     circulating androgen levels , in addition of several adverse side effects .      In this study, it is hypothesized that the administration of natural progesterone vaginally,     which will avoid hepatic first pass, may result in significantly less hormonal suppression.      The authors test this hypothesis by prospectively determining the effect of vaginal     micronized progesterone (OMP), administered for the induction of withdrawal bleeding, on the     circulating androgen and 17-OHP levels in women with PCOS.   "
15084|NCT03088033|"     Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control     group; 1:1 randomization.   "
15085|NCT03088020|"     The Center for Autonomic Medicine in Pediatrics (CAMP) has built the first International CCHS     (Congenital Central Hypoventilation Syndrome REDCap (Research Electronic Data Capture)     Registry. This registry is an international collaboration with CCHS patients and their     physicians recruited from around the world.      The purpose of this IRB-approved research study is to gain a better understanding of the     various clinical manifestations of CCHS with advancing age, and as related to each patient's     specific PHOX2B mutation. With a better understanding of specific CCHS PHOX2B mutations and     associated disease manifestations, we will be able to better anticipate healthcare needs and     to provide more accurate guidelines to healthcare providers world-wide in caring for patients     with CCHS.      The study aims to obtain detailed phenotypic information (information about health and     well-being) on patients with CCHS. Participation would require filling out a confidential     survey that asks questions regarding phenotype and past medical history. Involvement in the     project is completely voluntary and there is no compensation for taking part. However, this     project will help us learn more about this devastating disease, with the goal of advancing     treatment.   "
15086|NCT03088007|"     The EVAL'ID study aims to demonstrate the value of a multidimensional assessment in     accompanying schooling of children with Intellectual Disability. The study will be performed     in the Rhône department (France) in children aged from 5 to 13 years with mild to moderate     Intellectual Disability , and attending school either at ULIS (Unités Localisées pour     l'Inclusion Scolaire, which enables disabled children to attend regular schools), or IME     (Instituts Médico-Educatifs, which are special schools mandated to accommodate children and     young people with Intellectual Disability at any level of disability). A multidimensional     assessment encompasses the assessment of academic, cognitive, behavioral and adaptive skills     of the children, with validated and reliable neuropsychological batteries, called ID Kit     (Intellectual Deficiency assessment Kit), which includes the following scales : the Wechsler     Intelligence Scale for Children 4th edition (WISC-IV), the Vineland Adaptive Behavioral Scale     II, the GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger, which     is the French translation of the Nisonger Child Behavior Rating Form), and an academic skills     rating form (GEVA-SCO). A comparison of the children neuropsychological profiles according to     the type of school they attend, will be perform.      The project consists of three phases:        -  Stage 1: Collection of information from each child records at MDPH (Departmental          Administration for Disabled Persons), IME, ULIS schools, including the assessments that          were performed, and from a survey of both caregivers and parents regarding their          respective perception and knowledge of the child's disability        -  Stage 2: All the children who were not previously assessed with the ID kit will be          further evaluated using these tests. The results of these assessments will be shared          with parents and caregivers.        -  Stage 3: A survey regarding the perception and knowledge of the child's disability will          be carried out again among caregivers and parents.   "
15094|NCT03087890|"     Cotrimoxazole preventive therapy (CPT) is recommended for prevention of morbidity and     mortality due to Pneumocystis pneumonia and other infections in HIV positive patients with     low immunity. Common clinical practice is to start CPT in any patient with CD4 counts below     200/µL, and, conversely, to stop CPT when immunity has been restored by antiretroviral     treatment to CD4 counts above 200/µL or when viral suppression has been documented for 3     months. However, the latest WHO guidelines widely expands the indication for CPT by     advocating for settings with high prevalence of malaria and bacterial infections, that all     patients with HIV start CPT regardless of CD4 counts and clinical stage. Furthermore, WHO     recommends these patients to continue CPT indefinitely regardless of evidence of immune     restoration (The recommendation is for settings with high prevalence of malaria and bacterial     infections, not for high-income countries). There is limited scientific evidence to recommend     prolonged CPT, as studies have shown it is associated with modestly reduced morbidity due to     pneumonia, meningitis and malaria, but no corresponding reduction in mortality. The impact of     such a large increase in antibiotic use on the emergence of antimicrobial resistance has not     been thoroughly considered. Our previous studies in Tanzania showed that multidrug-resistant     bacteria frequently cause bloodstream infections with resultant very high case-fatality     rates. As genes encoding for multiple antibiotic resistance traits are transferred by     plasmids together with resistance towards cotrimoxazole, prolonged CPT will likely favor the     selection of carriage of multidrug-resistant gut bacteria. The proposed randomized clinical     trial is designed to assess whether prolonged CPT in HIV-positive patients results in     increased fecal carriage of multi-drug resistant gut microbes or increased nasal carriage of     methicillin-resistant Staphylococcus aureus (MRSA). Secondary endpoints are morbidity     (clinical events, hospitalizations) and mortality. Stool specimens, nasal swabs and clinical     data will be collected from persons attending voluntary counseling and testing facilities and     HIV-clinics in Dar es Salaam, Tanzania. The study results may have important impact on public     health in terms of assisting development of rational recommendations for CPT use, and may     help prevent emerging antibiotic resistance.   "
15095|NCT03086837|"     Physical inactivity is still a major public health problem. Active transportation i.e.     walking or cycling for transport can contribute to greater total physical activity. The     specific aim of this study is to evaluate if a 12-week mobile phone application can increase     time spent in active transportation (cycling or walking) and in moderate-to-vigorous physical     activity in Swedish adults aged 20-65 years.   "
15096|NCT03086824|"     The purpose of this study is to investigate the safety and effectiveness of subjects     receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases. This     study will evaluate treatment response and clinically significant adverse events. Other     relevant data may be documented as well.   "
15097|NCT03086811|"     Rise in childhood obesity and poor eating habits and eating problems is apparent over the     last decades. Parents are at lose what the correct way to tackle these problems may be. This     study examined whether professional behavioral and nutritional training of first time mothers     improves feeding relationship and infants eating habits at 12 months.   "
15098|NCT03086798|"     to investigate the effectiveness of techniques of either using Magill forceps or cuff     inflation in facilitation of nasotracheal tube advancement into trachea   "
15099|NCT03086785|"     The purpose of this study is to assess the efficacy and safety of patients who receive     apatinib single or combined capecitabine for treatment of patients with metastatic her-2     negative breast cancer.   "
15100|NCT03086772|"     This proposed pilot study of a Tai Chi intervention among older adults with multisite pain is     a direct extension of the investigators' current work examining attentional demands of     chronic pain in the older population. The main purpose of this randomized controlled trial is     to assess the feasibility and acceptability of a 12-week Tai Chi program for older adults     with chronic multisite pain and a history of falling. The investigators will examine the     effects of Tai Chi on pain characteristics, cognitive function, cognitively-mediated     mobility, and levels of pain-related biomarkers in community-dwelling older adults with     multisite pain and at least one fall in the past year (65 years and older, N=30 for Tai Chi     group and N=30 for mild exercise control group). The specific aims for this R21 developmental     grant application are: 1) to assess the feasibility and acceptability of a 12-week randomized     controlled Tai Chi program in preparation for a larger trial in community-residing older     adults. Specifically, the investigators will: 1A) Evaluate the feasibility of recruitment and     engagement of older adults who have chronic multisite pain in a 12-week Tai Chi intervention;     1B) Determine the optimal Tai Chi/exercise protocol and data collection protocol for planning     a larger trial; 1C) Assess the adherence of randomized participants to their assigned     treatment; 1D) Obtain information on differences in outcome measures and variations to be     used for power analysis in a larger trial. 2) To examine the efficacy of Tai Chi on pain     characteristics, pain-related biomarkers, cognitive function and cognitively-mediated     mobility. Specifically, the investigators will: 2A) Determine the effects of Tai Chi on     measures of pain severity and pain interference; 2B) Determine the effects of Tai Chi on     performance in tests of attention and executive function; 2C) Determine the effects of Tai     Chi on performance in complex mobility tasks (dual task gait measures); 2D) Determine the     effects of Tai Chi on levels of C-reactive protein (CRP), interleukin 6 (IL-6), tumor     necrosis factor alpha (TNF-α), and beta endorphin (β-endorphin).   "
15101|NCT03086759|"     Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic     options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If     proven to be effective in its intra-articular use, Platelet-rich plasma may help in the     treatment of these patients.      Goal:      Primary objective: To compare effectiveness in improving pain and function and the     medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus     intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary     knee osteoarthritis.      Secondary objective: To compare the medium-term effectiveness of intra-articular injection of     Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to     improve synovial hypertrophy and quality of life in these patients.      Methods: A prospective randomized controlled double-blind study with three groups (each with     n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular     infiltration in a single moment. Patients will be allocated to one of three groups: 1)     Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide     Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline     solution group: patients who will receive isotonic saline solution. The patients will be     evaluated by blind evaluators in 4 assessment times up to 12 weeks of follow-up through     clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical     improvement scale, quality of life questionnaire as the SF36), functional (Womac     questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and     ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and     semiquantitative Power Doppler).      Statistics: The following statistical tests will be used according to the need: Student's t     test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical     significance of 5% will be considered.   "
15102|NCT03086746|"     To provide insight into why vitamin D levels at baseline predict an adverse outcome including     hospitalisation, we will establish whether baseline vitamin D levels are an independent     marker of LV remodelling in patients experiencing an ST segment elevation myocardial     infarction.   "
15103|NCT03086733|"     This is a phase II single centre open label single arm pre-operative window of metformin     treatment in stage I-IIIa Non small cell lung cancer.      In which patients will be invited to participate by receiving Metformin treatment during 14     to 21 days at 850 mg BID until the day before surgery.      They will be followed closely for any Adverse Events during treatment and 30 days after     surgery. During treatment there will be no follow up tests except 1 fasting blood glucose at     week 2 of treatment.      Survival data will be prospectively gathered after study treatment has ended until death.   "
15105|NCT03086707|"     This study intends to evaluate the nasal mucociliary clearance (NMC) by determining the value     obtained for saccharin transit time (STT) test over the course of 12 hours following a single     cigarette use in smokers, to compare it relative to never smokers, and to examine the     relationship between plasma nicotine levels and STT value in smokers and never smokers.     Safety will also be monitored during the study.      The planned maximum study duration for a single study participant from Screening through     completion of study will be 33 days.   "
15919|NCT03077113|"     This is a prospective study of ventilation image comparison for lung functional information     incorporation in thoracic cancer treatment planning.   "
15106|NCT03086694|"     Orthognathic surgery, one kind of Oro-maxillofacial surgery, is a complicate surgery that     undergoes several hours with nasotracheal intubation general anesthesia. To limit blood loss     during operation, the patients are often under intentional hypotension. However, the     intentional hypotension may confuse with hypovolemic induced low blood pressure. The     hypothesis is using flotrac (to measure stroke volume variation) to keep the patients     hemodynamics stable under Tridil and propofol infusion and avoid over-infusion of crystalloid     or colloid and prevent hypovolemia induced postoperative nausea and vomiting.   "
15107|NCT03087864|"     Objectives The primary objective of this study is to assess the feasibility of preoperative     treatment with atezolizumab combined with preoperative chemoradiation (carboplatin,     paclitaxel and radiation) in terms of completion of treatment with atezolizumab.   "
15108|NCT03087851|"     Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that     prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease     bone resorption and fracture risk, and many patients will reach osteopenic BMD levels on     treatment with denosumab. The treatment effect on bone turnover and BMD has, however, been     demonstrated to be reversible. This study will show if the bone mass can be maintained by     administrating zoledronic acid and if timing of the first dose of zoledronic acid after last     dose of denosumab matters.   "
15109|NCT03087838|"     Postoperative delirium may result in many adverse complications. At present little is known     about postoperative delirium in patients after crniotomy because they may manifest similar     symptoms to definitely delirium for some structural brain disease. Objective of this study is     to find out incidence and risk factors of postoperative delirium in patients after elective     craniotomy and also the relationship of postoperative delirium with clinical outcome.   "
15110|NCT03087825|"     During preoxygenation, imperfect seal between the face mask and patient's face can induce an     inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could     cancel the effect of the leak.      This is a prospective study. Healthy volunteers are randomised in cross-over between     spontaneous breathing or noninvasive ventilation pressure support preoxygenation in the     presence or absence of a calibrated leak on the inspiratory circuit.   "
15111|NCT03087812|"     This is an observational study in which data on consecutive patients who undergo     ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 4 new     ureteroscopes are used (2 from Olympus and 2 from Storz) to study the durability of the     ureteroscopes and the possible microbiological load.   "
15112|NCT03087799|"     Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances     compared to their healthy counterparts and compared to patients with other GI disorders. This     pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia     (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4     weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of     the current project is to assess feasibility of administering BBT-I to a sample of patients     with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI     population, this project will provide information about treatment adherence, recruitment, and     effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS     symptom severity.   "
15113|NCT03087786|"     To study the oral mucosal effects in adult smokers associated with the use of two Nicotine     Lozenge formulations.   "
15114|NCT03087773|"     This study is planned to investigate the impact of Empagliflozin on biomarkers of heart     failure in patients with myocardial infarction with and without type 2 diabetes mellitus     within 6 months after the event.   "
15115|NCT03087760|"     The main purpose of this study is to assess the safety, tolerability and anti-tumor activity     of the experimental study drug pembrolizumab (also known as Keytruda or MK-3475) in people     with non-small cell lung cancer (NSCLC) that has come back after radiation therapy.   "
15116|NCT03087747|"     In a setting of acute cholecystitis (AC) one of the treatment option is percutaneous     transhepatic cholangiography (PTHC) drainage. The goal of current study is to evaluate some     radiology aspects and correlate with clinical patient outcomes in patients with acute     cholecystitis severity grade III (presented as acute cholecystitis with organ dysfunction).   "
15117|NCT03087734|"     Pectus excavatum (PE) is the most common deformity of the chest wall, occurring in     approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is     consolidating as preferred technique for the treatment of this condition. In this technique a     metal bar is inserted in retrosternal position, pushing the sternum without the necessity of     resecting the condral cartilages. Despite the advantages obtained with this technique, it is     not without complications and the displacement of the bar is one of the most important. In     order to minimize this problem we developed a new model of stabilizers, as well as all     necessary instruments for performing minimally invasive surgery. The aim of this study is to     compare two surgical groups, one making use of the new oblique stabilizer compared to the     conventional perpendicular stabilizer to determine which one has less displacement.     Furthermore, this study also aims to assess the full range of instruments developed by a     national company, to carry out this type of surgery, which has cost compatible with our     economic reality, and that can be accessible to our Public Health patients.   "
15139|NCT03087448|"     This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic     lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will     investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK     or ROS-1 rearranged NSCLC. The Phase II portion will investigate the clinical efficiency of     the combination of ceritinib and trametinib in 3 single arm cohorts: ALKi (ALK inhibitor)     naïve patients; post-crizotinib progressed disease (PD) patients; and PD second line ALK     tyrosine kinase inhibitor (TKI) patients.   "
15140|NCT03087435|"     It is necessary and important to design tools to evaluate a central aspect of medical     residents formation. The research group has been working with resident well-being since a few     years in order to improve the global quality of the education and working environment. The     investigators present a plan to develop and validate a tool to assess residents well-being. A     tool designed with this characteristics would be of much importance to monitored as a     security event, managed and actively promoted well being in residents.   "
15141|NCT03087422|"     This study evaluates the text message (SMS) with orientation to help the management of     chemotherapy treatment.   "
15118|NCT03087721|"     The primary objective of the study is to compare the efficacy of an intervention with     high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE)     on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in     adults with metabolic syndrome (MS).      The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on     glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma     levels of musclin and apelin in adults with MS.      The investigators hypothesized that HIIT-LV is more effective in decreasing insulin     resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing     plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh,     than CAE.   "
15119|NCT03087708|"     This randomized pilot clinical trial studies the side effects and best dose of naloxegol and     to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer.     Naloxegol may relieve some of the side effects of opioid pain medication and fight off future     growth in the cancer.   "
15120|NCT03087695|"     Epstein-Barr virus (EBV) has been proven to process a strong association in patient of     nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide     reliable informations in early detecting tumor recurrence or risk grouping.   "
15121|NCT03087682|"     OCT is now an established way to measure the thickness of the Retinal Nerve Fiber Layer     (RNFL) in the retina of the eye. The thickness of the RNFL is always a reflection of the     number of the RNFs in any particular area of the retina. Each single RNF runs a long course     starting from the cell body which is the retinal ganglion cell in the retina and ends in the     thalamus of the brain where it relays visual information to other nerve cell in the thalamus.     Along this long course RNFs are in close anatomical relationship with the pituitary gland     crossing just above this gland about midway along their course. Hence enlargement of this     gland can interfere with the RNFs.   "
15122|NCT03087669|"     This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in     early stages after surgical implantation. Within the first 2 days of postoperative ICU care,     20 patients will firstly be exposed to 4 different LVAD pump flow settings with a stable     blood pressure. A second intervention will be mean arterial blood pressure (MAP) adjustments     to 4 preset levels (60-70-80 and 90 mmHg) with a constant preset LVAD flow. The two     manipulations; 1) Constant MAP with variation of LVAD flow and 2) Constant LVAD flow with     variation of MAP, will be monitored by Central hemodynamic parameters, echocardiographic     parameters and cerebral blood flow velocity (CBFV) parameters. The purpose of the trial is to     find the optimal combination of LVAD pump flow, mean arterial pressure and right heart     ventricle function for each patient. And at the same time describe the effect of flow and     pressure variations on CBFV.   "
15123|NCT03087656|"     Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to     treat bile duct stones, obstructive jaundice, biliary leaks, and a variety of other     conditions.      There is active debate whether antibiotics should be given prophylactically for ERCP outside     of high risk indications including primary sclerosing cholangitis. In part this is due to a     lack of appropriately powered clinical trials with adequate follow up. The aim will be to     assess whether prophylactic antibiotics decrease the rate of post ERCP cholangitis as defined     by the Revised Tokyo Criterion.   "
15124|NCT03087643|"     With aging, vascular function (VF) declines. Inactivity and sedentary life style have been     shown to contribute to the worsening of VF. Furthermore, bed rest, a condition commonly used     for the management of many chronic conditions, has been proven to lead to even more     deleterious consequences, including VF decline.      This study evaluates the effect of passive mobilization of the lower limbs on VF in bedridden     oldest-old. Half of the participants will undergo passive mobilization treatment in addition     to standard therapies, while the other half will receive only standard therapies. We     hypothesize that passive mobilization may improve nitric oxide (NO)-mediated endothelial     function.   "
15125|NCT03087630|"     This research examines a theoretically informed web-based personalized feedback intervention     to reduce alcohol-related risky sexual behavior among young adult drinkers. To accomplish     this objective the study has enrolled a national sample of 1200 young adults aged 18-20 and     is in the process of assessing them at 3-, 6-, 9-, and 12-months. The investigators will     evaluate the overall efficacy of the interventions based on the Prototype Willingness Model     by comparing underage young adult drinkers randomly assigned to receive the reason-based     pathway intervention (n=300), the social-based pathway intervention (n=300), or the     integrated intervention based on the full Prototype Willingness Model (both pathways, n=300)     to an attention control group (n=300). The investigators will examine whether changes in     components of both the reasoned and social pathways and drinking mediate intervention     efficacy on reducing alcohol-related risky sexual behavior. Past behavior and college student     status will be evaluated as moderators of intervention efficacy. The proposed study is both     significant and innovative in that it will evaluate brief interventions among a national     sample of young adults attending and not attending college, will utilize social networking     sites for participant recruitment, and will test the efficacy of interventions based on     individual and integrated pathways of the Prototype Willingness Model.   "
15126|NCT03087617|"     Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT     lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate     the Report's effectiveness at motivating smokers to call a Quitline.   "
15127|NCT03087604|"     The purpose of this randomized, observer-blinded, investigative trial is to determine if the     use of electrical stimulation, compared to the traditional loss of resistance technique     alone, improves the success rate of epidural catheter placement at an academic teaching     institution.   "
15128|NCT03087591|"     This phase I trial studies the side effects and best dose of APN401 in treating patients with     pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places     in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
15129|NCT03087578|"     This study compares electroacupuncture to mirabegron for treatment of overactive bladder     (OAB) symptoms in women who have failed treatment with anticholingeric therapy.   "
15168|NCT03087071|"     The goal of this clinical research study is to learn if panitumumab alone or in combination     with trametinib can help to control advanced colorectal cancer. The safety of these drugs     will also be studied.   "
15130|NCT03087565|"     All hysterectomies were performed intrafascially using the clamp-cut-ligate method as     described by (Jones, 2003);      Careful examination under anesthesia.      Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.A     transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm through     which the abdomen is opened in layers.      During subtotal hysterectomy procedure, the corpus is amputated just below the level of the     isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery.     The cervical stump is closed using vicryl 0 sutures.      During total hysterectomy procedure, the urinary bladder is dissected off the lower uterine     segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done using     a finger pushed gently against the cervix rather than against the bladder. Sharp dissection     using Metzenbaum scissors is performed in patients with previous cesarean sections, with     upward traction on the bladder peritoneum and the uterine fundus stretched tightly out of the     pelvis, the tips of the Metzenbaum scissors rest lightly on the fascia overlying the cervix     with small bites to develop a tissue plane, dissecting the bladder from the anterior cervix.      Revision of all pedicles to ensure hemostasis.      Intraoperative antibiotics (1 gm of a 3rd generation cephalosporin + 0.5 gm metronidazole).      The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens     were sent for pathological examination in the pathology Unit.   "
15131|NCT03087552|"     The spreading of transcatheter aortic valve implantation has paradoxically increased the     spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is     currently used as destination therapy for patients excluded from transcatheter aortic valve     implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic     valve replacement, or as a stratification tool for selected high-risk patients who cannot be     immediate candidates for transcatheter aortic valve implantation. Moreover, it has been     recently showed that transcatheter aortic valve implantation without balloon aortic     valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon     aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve     implantation, mainly related to access site or temporary pacemaker implantation. Thus, a     transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular     support wire could be extremely appealing.   "
15132|NCT03087539|"     Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab®     (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double-Blind,     Placebo-controlled and Parallel Group Trial   "
15133|NCT03087526|"     The purprose of this study is to develop and validate an analytical and clinical NIPD test     for triplet repeat disesases by isolated circulating fetal trophoblastic cells (CFTC)     analysis from maternal blood, searching for the familial mutation in families at risk of     having one of the following triplet repeat diseases: Huntington's disease, Myotonic     dystrophy, Fragile X syndrome, spinocerebellar ataxia 1, 2 and 3.   "
15134|NCT03087513|"     Intraoperative monitoring of the motor evoked potentials has been shown to be both a     sensitive and specific indicator for detecting intraoperative neurologic injuries during     spine surgery.(Fehlings, Brodke et al. 2010) It is utilised whenever there is risk for injury     of nerve roots or the spinal cord during the procedure.      Anaesthetic agents, especially the inhaled volatile anaesthetics and muscle relaxants, are     confounders for motor evoked potential monitoring as they have deleterious effects on the     amplitude of motor evoked potentials.(Sekimoto, Nishikawa et al. 2006) Hence, total     intravenous anaesthesia with no intraoperative muscle relaxants, are the standard anaesthetic     technique for these surgeries.      Muscle relaxants are usually required during the induction of anaesthesia and endotracheal     intubation of larynx. Current practice is to wait for the resolution of residual     neuromuscular blockade before the motor evoked potential recordings (MEPs) are initiated and     this makes it difficult to assess if there was any neurological injury associated with     positioning of the patient. A previous case series has shown that reversal of muscle relaxant     can improve the amplitude of MEPs.(Batistaki, Papadopoulos et al. 2012) The aim of this study     is to perform a randomised controlled trial to study the changes in motor evoked potential     amplitudes comparing sugammadex and placebo.   "
15135|NCT03087500|"     The overall goal of this study is to evaluate biomarkers of oxidative stress, mitochondrial     function, and DNA methylation (epigenetics) in order to determine the extent to which these     biomarkers are related to cognitive, behavioral and adaptive function in Down Syndrome. The     inter-relationship between measurable biomarkers and functional/cognitive abilities will move     beyond genetics to provide unprecedented new knowledge and a broader understanding of the     underlying pathophysiology and abnormal gene expression induced by trisomy 21.   "
15136|NCT03087487|"     The primary objectives of this study are to compare the risk of major bleeding and     stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial     fibrillation (NVAF) patients initiating OAC warfarin or apixaban treatment.   "
15137|NCT03087474|"     In a population of patients with venous thromboembolism and treated with oral anticoagulants     (OAC) in routine clinical practice in Denmark this study will describe patients treated with     each OAC   "
15138|NCT03087461|"     Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's     life for years after treatment has ended. Research shows that regular exercise limits many of     these side effects. However, less than 30% of BC survivors regularly exercise due to many     barriers that include patients being unaware of the benefits of exercise, health     professionals facing institutional, personal, and patient-related barriers to promoting     exercise, and a lack of knowledge translation (KT) strategies within cancer institutions that     focus on accessible exercise interventions and education by physiotherapists. For this     project, a pilot study is needed as the first step in order to assess process and resource     variables before implementation of a large-scale intervention.      The primary objective of this pilot trial is to assess the feasibility of conducting a larger     trial to evaluate the effects of a novel KT intervention using exercise and self-management     versus usual care among BC survivors. The secondary objective is to determine preliminary     estimates of effects of the KT intervention of exercise plus self-management (SM) program     versus usual care on (a) levels of exercise knowledge and behaviour, (b) health related     quality of life and (c) resource utilization, among BC survivors over a four month period.   "
31488|NCT02873611|"     Estimation of the localization accuracy of the genicular ablation procedure applied for     chronic pain suppression   "
15143|NCT03087396|"     Post Market clinical outcomes study to collect data on the short - and long-term outcomes for     subjects who are undergoing or who have undergone the Subchondroplasty Procedure in the foot     and/or ankle in a standard clinical setting. Outcomes to be assessed include pain medication     usage, pain, function, activity levels and patient satisfaction.   "
15144|NCT03087383|"     In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently     used due to brain relaxation and less effect on electrophysiologic monitoring. Response to     propofol can vary between individuals and be associated with clinical factors including age     and weight, and genetic polymorphism. Because the importance of rapid recovery in     neurosurgery with long operation time is emphasized recently, the choice and dose adjustment     of anesthetics should be determined according to clinical and genetic factors. Recently,     researches about genetic variations have been performed with single nucleotide polymorphism     (SNP). The aim of this study is to find SNPs associated with propofol recovery and response     through genome-wide association study (GWAS) in Korean adult population undergoing propofol     based TIVA for clipping of unruptured cerebral aneurysm.   "
15145|NCT03087370|"     This natural history study is a prospective and retrospective, observational study of WHIM     patients. WHIM syndrome is a rare, genetic, primary immunodeficiency disorder (a disorder in     which the body's immune system does not function properly). WHIM is an acronym for some of     the symptoms of the disorder - Warts, Hypogammaglobulinemia (low levels of certain     antibodies), Infections and Myelokathexis (too many white blood cells in the bone     marrow).This study includes 10-year retrospective (Retrospective Phase) and up to 5-year     prospective (Prospective Phase) components.   "
15146|NCT03087357|"     This study will document the detection rate and false positive rate as well as failure rate     of a new prenatal screening approach ('Smart NIPT') as described at www.vanadisdx.com and     implemented in an academic laboratory with limited molecular testing experience. Testing will     be performed on samples from a general risk pregnancy population, with additional high-risk     cases added to improve confidence in the detection rate. Additional characteristics of this     non-NGS test such as turn-around time, costs (equipment, training, per test), results     reporting, fetal sex, fetal fraction, and quality measures will also be examined.   "
15147|NCT03087344|"     This is a study that will evaluate the utility of measuring liver and spleen stiffness before     and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient     elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding     cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.   "
15148|NCT03087331|"     This is a prospective, pre post, pilot cohort study to be conducted in patients with chronic     pain, which is defined as pain that lasts beyond 3 months. To accomplish the primary and     secondary objectives of the study, three phrases will be designed and completed during three     months   "
15149|NCT03087318|"     Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular     diseases. In our study, we want to promote sport practice to reduce that burden in the first     place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of     this clinical trial is to determine which type of program, conducted in a digital environment     associating a mobile application and individual coaching, better improves exercise habits     over a 3-month period in overweight or moderate obese OSA patients.   "
15150|NCT03087305|"     Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are     essential for selection of an appropriate management strategy. Endobronchial ultrasound     transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to     evaluate involvement of mediastinal lymph nodes (LN); however, it is an invasive procedure     and may not be tolerated in patients with severe underlying lung disease. One exception is     the superficially located supraclavicular lymph nodes (SCLN), which can easily be biopsied     with percutaneous US-guided-fine needle aspiration (US-FNA). Traditionally, this nodal group     is evaluated by palpation; however, literature suggests that palpation itself fails to     capture 66% of proven disease by cytology, which challenges the acceptance that non-palpable     nodes are indicative of absent disease. Since all palpable SCLN are biopsied to rule out     metastasis, we may potentially up-stage more patients using ultrasound evaluation for     non-palpable nodes; and offer more appropriate management. Currently, the incidence for     non-palpable SCLN metastasis has not been defined in this patient population presenting for     EBUS-TBNA. The primary objective is to determine the incidence of supraclavicular lymph node     metastasis by ultrasound evaluation in patients referred for EBUS-TBNA.   "
15151|NCT03087292|"     In our clinical controlled trial, patients with coronary heart disease will be randomly     assigned into the exercise intervention (low intensity resistance training with vascular     occlusion) or usual physical activity group (control group).   "
15172|NCT03087019|"     This research study is studying immunotherapy with or without radiation therapy as a possible     treatment for adenoid cystic carcinoma.      The immunotherapy involved in this study is:        -  Pembrolizumab (MK-3475 or KEYTRUDA).   "
17027|NCT03062644|"     The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active     comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308     with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).   "
15173|NCT03087006|"     Patients with dry eye disease (DED) will be randomized to Automatic Self Transcending     Meditation (ASTM) plus Treatment as Usual (TAU) or TAU alone to assess changes in     Health-related quality of life (HRQoL). HRQoL is a vital construct focusing on impact of     health on quality of life. HRQoL data is used in economic evaluations, a component of health     economics that compares the cost and consequences of alternative courses of action. This     helps policy-makers make complex financial decisions. Along with HRQoL we will measure     changes in extent of depression as well as anxiety. Previously published data lacks     information of HRQoL in patients with DED. Through this study we shall attempt to correlate     HRQoL in this population and assess if ASTM confers changes in HRQoL along with depressive     and anxiety symptoms.   "
15266|NCT03085641|"     To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure     (CHF) and central sleep apnea (CSA).      This study is a prospective one armed uncontrolled intervention pilot study investigating 4     weeks of nHFT at home in 10 patients with CHF and CSA.   "
15152|NCT03087279|"     Background: Active learning is designed to pair physical activity with the teaching of     academic content. This has been shown to be a successful strategy to increase physical     activity and improve academic performance. The existing designs have confounded academic     lessons with physical activity. As a result, it is impossible to determine if the subsequent     improvement in academic performance is due to: (1) physical activity, (2) the academic     content of the active learning, or (3) the combination of academic material taught through     physical activity.      Methods / Design: The Texas I-CAN project is a 3-arm, cluster randomized control trial in     which 28 elementary schools were assigned to either control, math intervention, or spelling     intervention. As a result, each intervention condition serves as an unrelated content control     for the other arm of the trial, allowing the impact of physical activity to be separated from     the content. That is, schools that perform only active math lessons provide a content control     for the spelling schools on spelling outcomes. This also calculated direct observations of     attention and behavior control following periods of active learning.      Discussion: This design is unique in its ability to separate the impact of physical activity,     in general, from the combination of physical activity and specific academic content. This, in     combination with the ability to examine both proximal and distal outcomes along with measures     of time on task will do much to guide the design of future, school-based interventions.   "
15153|NCT03087266|"     Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non     surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach     (Q-SRP).      Patients will be seen one day and three months (study completion) after treatment. The 24     hours appointment will be occurring after the entire completion of the FM-SRP or the first     quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed     within the following 3 weeks.      At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial     parameters will be collected. Periodontal parameters will be checked at baseline and at three     months.      Main outcome of the study is the level of C-reactive protein 24 hours after treatment.   "
15154|NCT03087253|"     Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated     prevalence of less than 2,000 in the United States. These rare disorders characterized by     selective loss of adipose tissue and predisposition to insulin resistance and its metabolic     complications diabetes, dyslipidemia and hepatic steatosis. Due to these metabolic problems,     atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and     other morbidities complicate the lives of these patients.      In the last few years, several genes for CGL (AGPAT2, BSCL2, CAV1 and PTRF); FPL (LMNA,     PPARG, AKT2, CIDEC, LIPE, PLIN1, PCYT1A and ADRA2A); MAD (LMNA and ZMPSTE24); APS (LMNA);     autoinflammatory (PSMB8); NPS (FBN1, CAV1); SHORT syndrome (PIK3R1); and MDP syndrome (POLD1)     have been identified. However, there is paucity of information about the natural history of     these rare syndromes, especially genotype-specific causes of morbidity and mortality.      To overcome the problems outlined above, this multicenter, collaborative, prospective,     observational natural history cohort study will be conducted on approximately 500 patients     with genetic lipodystrophy syndromes. Patients will be assessed on a yearly basis for     approximately 4 years to collect robust clinical, metabolic, morbidity and mortality data.     Medical history and patient questionnaires will be completed on a yearly basis by patients     registered in the study. Clinical data such as vitals, laboratory results and anthropometric     measurements will also be collected from patients' medical records if available.   "
15155|NCT03087240|"     This study evaluates the influence of dental prophylaxis on disease activity of Rheumatoid     Arthritis. In addition to standard antirheumatic therapy, recently the question has been     raised whether or not there is a supplementary beneficial effect due to professional teeth     cleaning. So far just a few studies pursued this question, indicating that prophylaxis by     dental professionals can alleviate the symptoms of Rheumatoid Arthritis. To further evaluate     this question, in our study half of the participants will receive dental prophylaxis at their     first visit, after 2 weeks and 3 months, while the other half will receive professional teeth     cleaning after 3 months only.   "
15156|NCT03087227|"     The use of e-health in improving the quality of health services is a rapidly expanding     research area, in particular its usefulness in patient management of the home-hospital care     pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy     and better identification of low-risk patients who can be treated at home could be made     possible by these technologies.      The objective of this study is to evaluate a shared health information system (NEUTROSIS) for     home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims     to compare the average length of hospital stay for febrile neutropenia among patients     receiving NEUTROSIS and those receiving standard care      Materials and methods A shared information system (NEUTROSIS) has been developed to connect a     smartphone web application for the patient to the existing shared medical record of the Paris     Sud hospital group (AP-HP, France - 4D software).      The study consists of conducting a randomized controlled trial to compare a cohort of     patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies     using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by     the hospital's standard care over a treatment period of six months (n=100). During the 15     days following each chemotherapy cycle, the 2 groups of patients must take their temperature     daily. Both groups are trained like any patient under chemotherapy to contact the team in     case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other     symptoms on the smartphone application. This information is then transmitted instantly to the     hospital care team who will be alerted in case of fever and will contact the patient. The     control group will indicate these same data in a paper diary and will have to contact the     health team in case of fever as done in the usual care.      The two groups of patients will be followed 6 months through a questionnaire asked to the     patient at each hospital visit for chemotherapy cycle. The questionnaire collects information     on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last     follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study     will take place in two hospital sites of the Paris University hospital (A Béclère and     Kremlin-Bicètre).   "
15157|NCT03087214|"     The epidemiology and ecology of malaria in humans includes complex interactions between human     hosts and mosquito vectors. These interactions are spatio-temporal in nature and are heavily     dependent on transportation capabilities and seasonal conditions. Where and when infections     are acquired is not well understood in the Greater Mekong Subregion (GMS), where there are     numerous vectors, many with different behaviours and habitats. For example, many infections     appear to be associated with forests or forest edges and some of the most important mosquito     vectors in the region are forest dwellers (Obsomer, Defourny, and Coosemans 2007).     Interventions that target houses at night-time (e.g. mosquito nets), have had limited success     in the GMS, most likely because at least some infections are acquired during the day or     outside of the home (Dolan et al. 1993; Luxemburger et al. 1994).      While overall malaria incidence in the region appears to be declining, the disease remains     persistent in small subregions, for example along international borders joining Thailand with     Myanmar. It will be crucial for elimination efforts to address the persistent malaria in     these regions, most likely requiring the use of novel and spatially targeted approaches.      Increasingly, spatial data and analyses are used in disease research (Linard and Tatem 2012;     Pybus et al. 2016; Tatem et al. 2012), however most spatial analyses are at aggregate scales,     using data from provincial or state levels. More detailed studies have a single geographic     reference point per individual in the study, frequently the home (Mosha et al. 2014; Parker     et al. 2015). These studies allow researchers to investigate potential clustering of cases     within and between houses (hotspots) (Bejon et al. 2014; Bousema et al. 2012; Mosha et al.     2014). Even these detailed studies typically ignore the spaces in which people spend time     outside of their home and where they may acquire infection: schools; places of worship and     work; forest camps and temporary shelters. Given that many malaria infections in the GMS are     acquired outside of the home, in areas that are not usually mapped, this information is     important for developing strategies to prevent transmission and will be crucial for achieving     elimination.      Researchers in other substantive areas have already begun mapping the movement patterns of     study subjects so that exposure to a variety of environmental exposures outside of the home     can be assessed (Matthews and Yang 2013; Vazquez-Prokopec et al. 2010). Early approaches     relied on travel surveys or travel diaries, both having bias of unknown magnitude. Modern     wearable global positioning satellite (GPS) instruments (loggers or trackers) and geographic     information science (GIS) enable detailed mapping and quantification of human movement     patterns. Through analysing differences in the movement patterns between humans who do versus     those that do not acquire infectious diseases, it may be possible to identify a narrower set     of geographic spaces in which disease transmission is occurring. Public health interventions     could then target those risk areas.      Most of these detailed studies have been done in economically developed settings and urban     environments. Infectious diseases such as malaria remain persistent in resource-poor, rural,     and remote areas - the very regions that are least likely to be studied with detailed     approaches (Sachs and Malaney 2002).   "
15158|NCT03087201|"     This is a multicentre, randomized, double-blind, placebo controlled, parallel-group, phase     IIIb trial.      Patients (≥18 years) with chronic tic disorders and Tourette syndrome will be recruited.      The objective of the trial is to demonstrate that treatment with the cannabis extract     nabiximols is superior to placebo in reducing tics and comorbidities in patients with     Tourette syndrome and chronic tic disorders.   "
15170|NCT03087045|"     The purpose of this investigation is to investigate the behavioral manifestations of     listening effort. Quantifying listening effort based on an easy to measure behavioral metric     would allow for better understanding of the effort that goes into processing conversational     speech. The investigators hypothesize that the behavior modifications required to improve the     signal to noise ratio in increasingly complex listening environments significantly deviates     from quiet listening environments. Further, the investigators hypothesize that this directly     contributes to increased listening effort and reduced ability to accurately monitor content     for everyday conversation.   "
15159|NCT03087188|"     There are different therapy strategies for patients suffering on obstructive lung disease     like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of     these strategies includes inhalative drugs, e.g. ß2-mimetics, anticholinergic drugs, or     glucocorticoids, which are indicated often and which can be used with different inhalation     devices. Dry powder inhalators, and dosieraerosol are used the most in clinical routine.     Further strategies in treating obstructive lung disease are innovative systems like Respimat     or systems with liquid inhalation. However, the success of the therapy depends on the correct     application technique. In the clinical routine a high error rate was observed. Consequently,     the initiative of the German league of respiratory tracts published internet-based film     sequences in order to demonstrate how to use an inhalator correctly. These films are     available in the internet for everyone and can be watched as often as needed in order to     improve technique and facilitate training.      Therefore, in this study we aim to evaluate the following aspects:        -  amount of wrong applications in ambulant and hospitalized patients (wrong in terms of          lack of knowledge on how to use the inhalator or incorrect utilization)        -  amount of correct applications in patients who had first used the inhalator incorrectly          but improved technique by watching the film sequences        -  evaluation of learning success within 2 weeks to 2 months (follow-up visit in the          ambulance)   "
15160|NCT03087175|"     NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous     coronary intervention (PCI) worldwide. PCI permit to reestablished coronary flow but     effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence     of distal embolization and no-reflow phenomenon. Distal embolization lead to coronary     microcirculation lesions. This complication is related to poor prognosis.      MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh     sleeve, which allows to prevent distal embolization during percutaneous coronary intervention     in ST-segment-elevation myocardial infarction.      Index of microcirculatory resistance (IMR) is a validated method to assess coronary     microcirculation.      Accordingly, the purpose of this study is to demonstrate that MGuard micronet mesh-covered     stent prevent distal embolization and microvascular reperfusion impairment during primary     PCI, compared with a bare metal stent (BMS) and drug eluting stent (DES) in patients with     NSTE-ACS, assessed by Index of microcirculatory resistance.   "
15161|NCT03087162|"     New drug regimen for Helicobacter pylori eradication, the investigators compare once daily     dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose     dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.   "
15162|NCT03087149|"     The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is     safer and more effective than standard therapy in pretrem infants.   "
15163|NCT03087136|"     Pediatric Multiple sclerosis (MS) is a chronic inflammatory disease defined by multiple     episodes of demyelination of the central nervous system (CNS) separated by time and space as     specified in adults not explained by acute disseminated encephalomyelitis (ADEM). Several     studies have indicated that at least 5% of MS patients are in the pediatric population, but     no prospective study was performed in Brazil. There are particular characteristics of     Pediatric MS that differs from the adult population and have been focus of interest in the     last years. However, we still lack high evidence data, specially concerning treatment, of     this age group.      This is an observational non-interventional multicenter study in pediatric MS patients in     which participating subjects will be characterized by their clinical, MRI and immunological     features. In this observational study, we will select 8 MS centers in Brazil to recruit at     least 100 pediatric patients currently followed on each center with idiopathic inflammatory     CNS disorders over a 2-year study period. We will collect retrospective and prospective     clinical and MRI data to determine the proportion of patients who fulfill the International     Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS,7 especially on those below     10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the     inclusion on the study, subjects will be followed for at least 2 years.      All subjects enrolled in this study will have serum collected to test autoantibodies     including anti-AQP4 and anti-MOG using cell-based assays with transfected cells.8 Pediatric     patients with positive testing for these autoantibodies will be analyzed separately.      Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS, we will     perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a     3-Tesla MRI (GE Signa HDx 3.0T, General Electric, Milwaukee, WI, USA) and a 8-channel head     coil to visualize remyelinating brain MS lesions. Normalized leptokurtic diffusion (NLD) data     will be acquired using diffusion-weighted echo planar imaging. All MRI scans from this     exploratory study will be performed at the Brain Institute of Rio Grande do Sul (BraIns).     Only patients with previous brain demyelinating lesions will be included in this exploratory     sub-study.   "
15164|NCT03087123|"     Community based interventions are more acceptable to community members when all participants     receive the intervention. A 'stepped-wedge' or 'multiple-baseline' design allows for all     participants to receive the intervention by randomizing participants into conditions defined     by the length of the baseline period. The primary aim of this pilot study is to gather data     that will allow the researchers to estimate parameters, such as the appropriate length of the     baseline period that will allow them to power a larger study. A second key aim is to     determine if a smartphone intervention that is delivered to parents can increase physical     activity in their 6-10 year old inactive children.   "
15165|NCT03087110|"     This study will investigate the safety of single dose intravenous infusion of cord blood     cells which were cryopreserved after the birth of a brother or sister to a child with     cerebral palsy.   "
15166|NCT03087097|"     This single-center, randomized, double-blinded trial will compare the safety and efficacy of     FMT given enema in subjects 18-60 months of age with uncomplicated, non-edematous SAM not     responsive to standard therapy. Subjects must meet inclusion criteria, no exclusion criteria     prior to randomization. Subjects will then be randomized by stratified random sampling (by     age, diarrhea, MUAC and hyponatremia) in a 1:1 ratio at each site to 1 of 2 treatment groups:        -  FMT by enema: 10mL/kg (maximum 60mL) of donor fecal material will be infused.        -  Placebo by enema: 10mL/kg (maximum 60mL) of placebo material will be infused.      Subjects will be evaluated through 56 days (±5) after randomization for primary outcomes     (safety) as well as secondary outcomes (nutritional, clinical and microbiological response).     See definition under endpoints/outcome measures above).      Stool samples will be collected at enrollment and through days 3, 7, 14, 21, 42 and 56.     Samples will be used for microbiome determination and other exploratory microbiological     endpoints. An aliquot of donor stool will also be stored for microbiome determination and     other exploratory microbiological endpoints and assessment of newly acquired infectious     agents.   "
15167|NCT03087084|"     The purpose of this prospective, non-randomized, single-arm, research study is to evaluate     the accuracy of acutely extracting respiratory rate and tidal volume from implanted cardiac     device impedance in subjects with heart failure.      In addition, to assess the feasibility of extracting respiratory rate from device EGM under     various conditions.   "
15174|NCT03086993|"     This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma.     Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4     treatment cycles. Following induction treatment patients will be randomize (1:1), to 2 arms     of treatment. One group (50%) will be receive high dose chemotherapy delivered specifically     to the liver, while the other group (50%) will continue treatment with Cisplatin and     Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer     advances. All patients will be followed until death. This study will compare the overall     survival (OS) in patients with intrahepatic cholangiocarcinoma.   "
15175|NCT03086980|"     Patients with glaucoma will be randomized to Automatic Self Transcending Meditation (ASTM)     plus Treatment as Usual (TAU) or TAU alone to assess changes in Health-related quality of     life (HRQoL). HRQoL is a vital construct focusing on impact of health on quality of life.     HRQoL data is used in economic evaluations, a component of health economics that compares the     cost and consequences of alternative courses of action. This helps policy-makers make complex     financial decisions. Along with HRQoL we will measure changes in extent of depression as well     as anxiety. Previously published data lacks information of HRQoL in patients with glaucoma.     Through this study we shall attempt to correlate HRQoL in this population and assess if ASTM     confers changes in HRQoL along with depressive and anxiety symptoms.   "
15176|NCT03086967|"     The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to     indicate ideal time of placement for optimal cervical ripening prior to induction. The     proposed study is a randomized control trial to determine if shortening placement from 12 to     6 hours of foley catheter can decrease time from start of induction to delivery. The     prediction is that shortening foley bulb placement will result in shorter induction times,     increased patient satisfaction and decreased length of stay on labor and delivery with     secondary decreased medical costs.   "
15177|NCT03086954|"     This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19     positive lymphoma with an infusion of the patient's own T cells that have been genetically     modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified     to express the CD19 protein on the cell surface. The study will determine if these modified T     cells help the body's immune system eliminate tumour cells .The trial will also study the     safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact     on this treatment for survival.   "
15178|NCT03086941|"     Aim of the work      To compare between use of I-gel as a conduit for blind intubation and as a conduit for     fiberoptic guided intubation in children and also aim to validate the use of I-gel as conduit     for blind intubation in absence of fiberoptic or lack of experience of its use.      Objectives:        -  To validate I-gel use as blind intubating conduit in children.        -  To Estimate the duration of blind intubation using I-gel and duration of fiberoptic          guided intubation through I-gel.      Ethical Considerations      The study protocol will be approved by the Research Ethics Committee.   "
15179|NCT03086928|"     Restoration of anterior teeth using conservative approach allows clinicians to provide     porcelain laminate veneers with excellent esthetics without extensive tooth structure     removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and     hybrid ceramics (Lava Ultimate). The aim of this study is to compare both e.max and lava     ultimate veneers clinically.   "
15180|NCT03086915|"     In retrospective data search the investigators will identified the percentage of patients     with muscle relaxants administered during perioperative period. The block reversal, typ of     drug, percentage of cases with and without reversal will be identified.   "
15181|NCT03086902|"     Several reports have shown the utility of PVC ablation with cryo catheters. The aim of this     study is to compare the outcomes and safety of Cryo vs. RF for PVCs.   "
15182|NCT03086889|"     The investigators will conduct a single-blind, randomized controlled trial of 60 patients     with subacute stroke. Patients will be randomly assigned into a control group and an     intervention group. The intervention group will participate in immersion VR training for 3     weeks. The control group will receive for traditional rehabilitation training for 3 weeks.     Then, the patients will be reevaluated to determine changes in upper extremity function,     cognitive function, cortical and subcortical activation patterns, and performance of     activities of daily living after the baseline assessment.   "
15183|NCT03086876|"     About 1-2% of the population have a Learning disability (LD). This is a lifelong condition     characterised by an IQ less than 70, general developmental delay and limitations in day to     day activities. Children and adults with LD are some of the most under-served groups in     society, with well documented health disparities and at four times the risk of developing a     mental disorder. Reports indicate that challenging behaviour, e.g. temper tantrums,     aggression or self injury, occurs in as many as 40,000 young people under 18 years living in     England. There is a significant evidence from research in the general population that     parenting groups which support parents in developing skills to manage such behaviours in     their child can be helpful. These programmes, if offered to parents early on, may reduce and     even prevent serious emotional problems and possible criminality from developing in the child     later in life. Cost benefits are associated with improved health and social outcomes in the     young person. The National Institute of Health and Care Excellence (NICE) guideline on     behaviour that challenges reviewed all the available evidence and found very few thoroughly     researched programmes specifically developed for children and young people with LD and     challenging behaviour. NICE, therefore, recommended that further research should be     undertaken to address the lack of evidence based interventions to reduce challenging     behaviour in the population of young people with LD.      In this study, we propose to evaluate a programme called level 4 Stepping Stones Triple P     (SSTP) delivered by trained practitioners to groups of parents of young children aged 30-59     months with moderate to severe LD . The programme lasts for 9 weeks and has shown positive     results in small trials outside the UK, indicating that it is a potentially helpful. However,     it needs to be tested within the UK health system before recommendations can be made to roll     it out. Level 4 SSTP helps parents understand and manage their child's behaviour and parents     may benefit from peer support in a group setting. We shall recruit 258 parents who will be     allocated to one of two groups by chance: one will receive SSTP and treatment as usual and     the other treatment as usual, a list of resources and the Contact a Family guide to     challenging behaviour. Treatment as usual includes support and advice by GPs or child     development teams. We shall use parental reports and observations of child behaviour to     examine whether SSTP reduces challenging behaviour at four (short term) and 12 (long term)     months after randomisation. We shall also ask other carergivers' about the child's behaviour,     the child's and the parent's health related quality of life, difficulties with care, parent     stress, service use and how the parent has found the intervention using both questionnaires     and face to face interviews.      We shall interview the service managers and the therapists about their experience of hosting     and delivering the intervention. We shall recruit parents to the Parent Advisory Group to     advise about various aspects of the study, e.g. materials, interview topic guides,     dissemination. We are a group of researchers and clinicians with expertise in LD, child     health and early intervention who have conducted several large trials with this population.      Our trial will last 48 months and will follow all statutory research governance requirements     to ensure that it is high quality, safe and ethical.   "
15184|NCT03086863|"     This is a multicenter, randomized, sham-controlled, patient- and assessor-blinded, and     parallel trial to explore the effectiveness and safety of electroacupuncture (EA) therapy,     compared with sham EA, for poststroke shoulder pain.   "
15204|NCT03086447|"     Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate     that the investigational contact lens meets the design requirements related to corneal     staining, lens fit, visual acuity and rotational performance as well as subjective comfort     and handling. Subjects will wear the contact lenses for a total of 28-36 days.   "
15215|NCT03086304|"     Postoperative intestinal obstruction is one of the most common complication of     gastrointestinal surgery, some research have confirmed that transcutaneous acupoint     electrical stimulation (TEAS) can promote recovery of gastrointestinal function, reduce the     incidence of postoperative nausea and vomiting, our goal is to investigate the effectiveness     of TEAS in reducing the incidence of gastrointestinal obstruction after operation in     perioperative.   "
15216|NCT03086291|"     Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days Cohort 1: 7.5     mg/kg bid for 7 days 14 days off Cohort 2: 10 mg/kg bid for 7 days 14 days off Cohort 3: ( )     mg/kg bid for 7 days 14 days off (to be determined based on PK data of cohort 1 and 2) Q 3     weeks   "
15218|NCT03086265|"     The purpose of this study is to investigate whether laser laryngeal surgery can be safely and     potentially more effectively performed without the use of tracheal intubation or jet     ventilation, under completely tubeless conditions. The patient's gas exchange will be     supported by rapid insufflation of high-flow oxygen through specialized nasal cannula: the so     called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).   "
15219|NCT03086252|"     This pilot study evaluates safety of administration of red blood cell transfusions requested     by patients based on their symptoms instead of levels of hemoglobin for the treatment of     chronic anemia in patients with blood disorders.   "
15185|NCT03086850|"     Main objective: To assess the effect of the daily physical activity promotion with a     pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to     moderate obstructive sleep apnea (OSA).      Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and     predominance of obstructive events [>80%)].      Design. Randomized, parallel and open-label clinical trial, controlled with conventional     treatment.      Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up     according to conventional clinical practice] or intervention group [in addition to     conventional treatment and follow-up, the patients will receive a pedometer to measure the     number of steps walked daily. Based on the cumulative step count for each day and the mean     value since the last visit, patients will receive a task to increase their steps per day by     the next appointment according to the next protocol (<6000 steps/day: increase by 3000     steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or     increase steps).      Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be     made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms,     comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ);     heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol,     LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP);     plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily     physical activity using an accelerometer.   "
15186|NCT03086681|"     A total of 120 patients with pathologically confirmed Locally advanced cervical carcinoma     were enrolled. Patients were randomly divided into two groups, with 60 patients in each     group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the     other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the     toxic of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and     progression-free survival of patients were analyzed. The investigators data may provide an     alternative option for the treatment of Locally advanced cervical carcinoma with high     efficacy and low toxicity.   "
15187|NCT03086668|"     to compare either using conventional jaw thrust technique or with a novel fingers-hook     technique to facilitate video-stylet assisted nasotracheal intubation   "
15188|NCT03086655|"     Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and     prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS),     and devices which wirelessly monitor adherence in real-time, have multiple limitations,     including over-reporting, inability to assess pill ingestion, and size/expense. Our     multidisciplinary research team at the University of California, San Francisco (UCSF) and in     India has designed a new adherence-monitoring device called Tel-Me-Box which is small,     low-cost, rechargeable, inconspicuous, and could be programmed to deliver tailored real-time     adherence reminders following additional hardware modifications. The aim of this study is to     modify and validate this discreet Tel-Me-Box (TMB) adherence monitoring and reminder device     against hair ARV concentrations as a pharmacologic measure of drug ingestion/adherence, a     measure pioneered and validated by our team, with the expectation that this device and     intermittent hair monitoring could have widespread utility for HIV and non-HIV adherence     science, both in India and globally.   "
15189|NCT03086642|"     The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can     be given safely to participants with pancreatic cancer that is either too big to be taken out     by surgery or has spread to other parts of the body. The study will also see if T-Vec can     cause tumor shrinkage or prevent its growth.      To find out which doses are safe, all participants enrolled in this study will receive up to     4 injections of T-Vec. At least two doses will be evaluated in this study, depending on how     many side effects are seen at each dose. Participants will not be able to pick the dose, as     this will be determined based on the study experience with participants enrolled previously.      T-Vec is called a study agent in this study. This is because the use of T-Vec in pancreatic     cancer is still experimental and has not been approved by any regulatory health agency, like     the Food and Drug Administration (FDA) or European Medicines Agency (EMA), for use in people     with pancreatic cancer. T-Vec however has been approved by the FDA for use in melanoma     population.   "
15190|NCT03086629|"     The Patient Concerns Inventory (PCI) for head and neck cancer (HNC) patients has been     developed and used largely within the confines of a single clinic setting and has not been     used routinely with patients in the first year following treatment. Research so far suggests     it is popular with patients, they would like to continue to use it in clinic and it is     feasible. Benefits of its routine repeated use is untested, notably its impact on improving     QOL and in reducing emotional distress, especially within the first year after treatment when     patients are more likely to benefit from repeated use of the PCI.      The overarching aim of the proposed research is to explore whether the routine use of the PCI     in review clinics during the first year following head and neck cancer treatment can improve     patients quality of life.      The primary outcome is an improvement in QOL. Secondary outcomes are:      social-emotional scale, distress thermometer and health economics.      This will be a pragmatic cluster randomised control trial with consultants randomised to     either 'using or 'not using' the PCI at clinic. It will involve two centres. 416 patients     from at least 10 consultant clusters are required to show a clinically meaningful difference     in the primary outcome.      Intervention; Patient completion of the PCI and its inclusion into the regular review clinic     consultation is the 'intervention' and is compared to standard out-patient follow-up. The     pre-consultation questionnaires and PCI will be used from the first post-treatment clinic     (i.e. baseline) onwards for one year. Completion of all pre-consultation questionnaires and     the PCI is by computer (IPAD).   "
15191|NCT03086616|"     This is a Phase I and Early Efficacy Study of Convection Enhanced Delivery (CED) of     irinotecan liposome injection (nal-IRI) Using Real Time Imaging with Gadolinium in Children     with Diffuse Intrinsic Pontine Glioma who have completed focal radiotherapy   "
15192|NCT03086603|"     The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the     patient after optimization to preload independence with a Goal Directed Therapy algorithm     guided by non invasive hemodynamic monitoring with Clearsight.   "
15193|NCT03086590|"     To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal,     respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation     with the obstruction level of COPD   "
15194|NCT03086577|"     Leg ulcers are a significant cause of impaired functional ability and quality of life for     approximately 1-2 percent of the population in western countries. Although pain seems to be     one of the most devastating aspects of living with a chronic ulcer, research is limited and     there is a lack of knowledge about wound-related pain characteristics. Little is known about     prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain     impact on physical- and psychosocial functioning, as well as relieving and exacerbating     factors.      The overall purpose of this study is to investigate the prevalence and characteristics of     wound related pain in patients with chronic leg ulcers. More specific research questions are:     1) What is the prevalence and characteristics of wound related pain in patients suffering     from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses     report the quality of the wound related pain, 3) Is there any differences in wound pain     characteristics among patients with different etiology leg ulcers, 4) How is the pain     temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported     quality of life in patients with different ulcer diagnosis, and 6) Is there any association     among pain characteristics, sleep and quality of life in patients with chronic leg/foot     ulcers? The study has a non-experimental, explorative and descriptive approach. A     cross-sectional questionnaire design will be used to explore patient's experience of     wound-related pain.      The patients will be recruited at the outpatient clinic appointment and home-care nursing in     Norway. Participants will fill out self-report questionnaires. The battery of questionnaires     will obtain information about demographic data, pain characteristics, quality of life and     sleep. Pain characteristics, quality of life and sleep will be assessed by using different     questionnaires that has demonstrated high validity and reliability. In addition, the temporal     pattern of pain will be assessed by asking the participants to fill out a form stating     subjective level of pain (NRS) every hour during a typical day, and to mark times that they     rest and sleep. Relevant information about the diagnosis/classification of ulcer,     comorbidities, the ulcer management and pain management will be collected in a clinical     examination.   "
15195|NCT03086564|"     The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma     (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer     cells escaping from immune surveillance and constructs an immunosuppressive microenvironment.     Correspondingly, dendritic cells activated by HBV antigen peptides and HepG2 cell protein     lysate can efficiently present T cells with antigens of HCC to sensitize their antitumor     properties meanwhile cyclophosphamide(CY) can effectively improve the microenvironment of     immunity. Therefore, we put forward a new scientific therapy called Activated     Dendritic-cells Combined Cyclophosphamide (ADCC) combining with TACE for patients with     advanced hepatocellular carcinoma to prolong their survival time.   "
15196|NCT03086551|"     This study uses a form on non-invasive brain stimulation called transcranial magnetic     stimulation to understand 1) understand how the brain learns post-stroke and 2) assess     non-invasive brain stimulation as an addition to current stroke rehabilitation approaches. In     two study arms the investigators will compare the effect of active transcranial magnetic     stimulation paired with motor practice with placebo (or sham) transcranial magnetic     stimulation paired with the same motor practice.   "
15197|NCT03086538|"     This study is single center single arm prospective phase II study. In this study, efficacy     and side effects of pemetrexed as salvage regimen on patients who failed all standard     chemotherapy and total of 29 patients will be enrolled. Pemetrexed will be continued until     disease progression is happened.   "
15198|NCT03086525|"     Musculoskeletal pain is highly prevalent, disabling, and with high socio-economic costs, with     many negative effects on quality of life. It affects the ability to perform work, social,     recreational and domestic tasks, changing the mood and concentration of this population.     Despite the worldwide prevalence and socioeconomic burden of this condition, a clear     understanding of its etiology and pathogenesis remains elusive.      Aims:      (i) to analyze the possible level of association between fear of pain, fear of movement,     self-efficacy, and pain acceptance on pain-disability at the start of the study and     prospectively evaluate its role as a risk factor; (ii) to evaluate the possible role as a     prognostic factor of fear of pain, fear of movement, self-efficacy and pain acceptance in     those who develop musculoskeletal pain at follow-up; (iii) explore the possible mediating     power of fear of movement and self-efficacy in the relationship between pain-disability; (iv)     investigate what percentage of the variance accounts for beliefs (fear of pain, fear of     movement, self-efficacy, and acceptance of pain) in predicting the onset and / or maintenance     of musculoskeletal pain.   "
15199|NCT03086512|"     The study was designed by the principal investigator, Dr. Alastair Younger, and the St.     Paul's Hospital Foot and Ankle Research Group, who will conduct the study. The study is being     funded by Acumed LLC, the manufacturer of the Health Canada approved Acutrak 2® - 7.5 fully     threaded screw.      The purpose of this study is to assess and compare the effectiveness of fully threaded screws     versus partially threaded screws in subtalar fusion, in order to determine the effect of the     thread configuration on the success of the fusion procedure.      Efficacy will be assessed primarily by computed tomography (CT) analysis of percent bone     bridging across the subtalar joint at both 12 and 24 weeks post-op. Outcome scores will also     be administered to compare general health and foot function between the two groups at     baseline and at multiple post-op follow-up visits. Additional resource utilization (i.e.     additional clinic and/or hospital admissions) will also be compared between the two groups     post-op.   "
15200|NCT03086499|"     The primary objective of this study is to describe the relative distances between patient     clinical profiles (i.e. patient clustering) in multivariate space.   "
15201|NCT03086486|"     To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid     plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either     pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.   "
15202|NCT03086473|"     This is a clinical trial which will investigate whether administration of caffeine, a     respiratory stimulant, to preterm babies soon after birth can prevent the need for a     breathing tube, or intubation. Many preterm babies who require intubation are intubated soon     after birth, often within the first few hours. If caffeine is given early enough and is     sufficient to stimulate effective breathing, perhaps these babies may not require intubation.     Additionally, caffeine may improve blood flow in preterm babies when given soon after birth.     Approximately half of babies in this study will receive caffeine within two hours after     birth, and half will receive caffeine 12 hours after birth. The hypothesis is that preterm     babies who receive caffeine within 2 hours after birth will have a lower incidence of     intubation than preterm babies who receive caffeine 12 hours after birth. The main secondary     hypothesis is that caffeine given soon after birth will enhance blood flow in preterm babies.   "
15203|NCT03086460|"     The purpose of this study is to evaluate the dose-response of different doses of CHF 1531 on     lung function and other clinical outcomes, to identify the optimal dose(s) in terms of     benefit/ risk ratio for further development in the target subject population.   "
15217|NCT03086278|"     AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to     evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.   "
15205|NCT03086434|"     This project will evaluate an after-school substance abuse prevention intervention, compared     to a standard substance abuse education program, targeting 6th grade AI youth in three AI     communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina.      A community-based participatory research approach will be used to culturally and     technologically adapt the intervention. A two-condition controlled study will evaluate the     efficacy of the intervention to increase AI youth Native self-reliance while decreasing AI     youth substance use involvement. An adult training program second level intervention study     will also be implemented to train tribal personnel from the three regional tribes on how to     implement the intervention as a tribal program beyond the study period.      Effectiveness will be determined by a small partial cross-over randomized trial comparing the     intervention to a wait-list control condition. Process evaluations will focus on the future     adoption and implementation of the intervention, and recommendations for sustainable     adaptations.   "
15206|NCT03086421|"     Many children with cancer are diagnosed in early childhood, and as such, will likely miss key     social experiences such as participation in preschool or kindergarten, playing on     playgrounds, and other normative experiences. In typically-developing children, it is known     that these experiences - and the skills that are learned during them - are critical to later     well-being. Very little is known about the psychological functioning of young children with     cancer, as studies have predominantly focused on those who are older (at least 8 years of     age). This study will explicitly assess social functioning in preschool-aged children with     cancer and follow the development of their social functioning from the end of treatment into     survivorship.      The goals of this pilot study are to begin to assess the impact of missed early childhood     social experiences, as well as the interaction with developing neurocognitive problems.      PRIMARY OBJECTIVE: Explore the impact of cancer in the central nervous system on social     functioning of young children (ages 4-6) after completion of therapy.   "
15207|NCT03086408|"     The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and     potentially more effectively performed without the use of tracheal intubation or a     supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE:     Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas     exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.   "
15208|NCT03086395|"     Patients with post transplant lymphoproliferative disorder (PTLD) that have been treated with     at least one type of chemotherapy, but whose lymphoma is not responding or coming back after     the previous treatment will be asked to participate in this study.      This clinical trial uses a drug called Obinutuzumab. The Food and Drug Administration (FDA)     has approved Obinutuzumab for sale in the United States for certain diseases. Obinutuzumab is     still being studied in clinical trials to learn more about what its side effects are and     whether or not it is effective in the disease or condition being studied. Obinutuzumab is     considered an investigational drug in this study      Obinutuzumab (GA101) is an antibody directed against cluster of differentiation antigen 20     (CD20). Antibodies are protein that are part of the immune system that can target cancer     cells. Obinutuzumab sticks to a target called CD20. CD20 is an important molecule on some     cancer cells (including non-Hodgkin lymphoma) and some normal cells of the immune system.      This study is being done to test if the study drug has an effect on post transplant     lymphoproliferative disorder and to see how lymphoma will respond to the study drug.   "
15209|NCT03086382|"     The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup     after single oral dosing in healthy Chinese male subjects.   "
15210|NCT03086369|"     The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and     gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic     cancer.   "
15211|NCT03086356|"     The primary objective of the trial is to investigate the pharmacokinetics and     pharmacodynamics of idarucizumab in Chinese healthy male and female subjects following     intravenous administration of idarucizumab followed by idarucizumab with 15 minutes interval     when administered at or close to the steady state of dabigatran.      Another objective of this trial is to explore the effect idarucizumab on the PK     (pharmacokinetic(s)) and PD (pharmacodynamic) parameters of dabigatran.   "
15212|NCT03086343|"     The comparison of safety and efficacy of ABT-494 versus abatacept in participants with     rheumatoid arthritis on a stable background conventional synthetic Disease Modifying     Anti-Rheumatic Drug (csDMARD) who have an inadequate response or intolerance to biologic     DMARDs.   "
15213|NCT03086330|"     This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare     the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose     co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or     sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2     diabetes. Subjects will remain on their pre-trial medication.   "
15214|NCT03086317|"     The study is an investigator-initiated trial comparing two different catheters (standard     versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood     clots in lung arteries with evidence or heart strain). Patients already planned for the     procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to     ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely     in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior     to standard CDT, the former being much more expensive and more commonly used.      The purpose of the study is to learn about which catheter-directed therapy is more suitable     for patients with pulmonary embolism (PE), who are candidates for both standard catheter     directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to     provide information regarding the cost effectiveness of the two different types of treatment.     A total of 80 patients are planned to be recruited. All medication administration, procedures     or in-hospital tests will be performed as routine clinical practice. The study will compare     short term and long term outcomes: resolution of blood clots on CT scan, right ventricular     size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.   "
15282|NCT03085433|"     This is a randomized controlled trial of couples with a history of poor embryo quality     undergoing a repeat in vitro fertilization (IVF) cycle for unexplained infertility. Couples     will be randomized to sperm selection by the clinical standard of centrifugation and     density-gradient processing compared to the microfluidic sperm sorting chip.   "
15221|NCT03086226|"     This study is a single-center, comparative, randomized, double-blind, parallel-group,     active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined     with surgery in subjects with eumycetoma in Sudan.      There will be three arms in this study: The first arm will be Fosravuconazole 300 mg weekly,     the second arm will have Fosravuconazole 200 mg weekly and the control arm is the standard     treatment using itraconazole 400mg daily.      At 3 months time-point, interim analysis will be done and one of the study arms will be     dropped according to the drop-the-loser design, based on efficacy or toxicity.   "
15222|NCT03086213|"     The aim of this study is to study the safety and effectiveness of the effects on the     perioperative pain control comparing between the thoracic paravertebral nerve block using the     camera guided and the intrathoracic intercostals nerve block for the management of     nonintubated local regional analgesia in uniport thoracoscopic surgery for the undetermined     solitary nodules patients.   "
15223|NCT03086200|"     CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to     determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence     intervention (iTAB) improves adherence to PrEP among transgender persons.   "
15224|NCT03086187|"     11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention     study.      It greatly reduces calf muscle forces without reducing ground reaction forces.   "
15225|NCT03086174|"     This is a phase Ib, open, mono-center, dose-escalation, tolerability and pharmacokinetic     study evaluating the Recombinant Humanized Anti-PD-1 mAb for Injection in combination with     Axitinib in patients with advanced kidney cancer and melanoma who have failed in routine     systemic treatment.   "
15226|NCT03086161|"     50-70% of adolescents gain too much weight during pregnancy, and this excess gain     significantly increases their risk of high postpartum weight retention and long-term obesity.     In this randomized controlled pilot study, the investigators are evaluating the feasibility     and acceptability of a relatively brief interpersonal psychotherapy program for reducing     excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual     prenatal care delivered in an adolescent maternity clinic, the investigators will estimate     the added benefit of an interpersonal psychotherapy program's effectiveness for reducing     excess gestational weight gain, improving maternal postpartum insulin sensitivity, and     decreasing maternal and infant adiposity.   "
15227|NCT03086148|"     Perioperative depression symptom is one of the common metal complications which will affect     patients' clinical outcome and prognosis and it may reduce long-term quality of life (QOL).     However, there isn't any effective treatment can relieve patients' depression symptom. To     date, lots of clinical trails have confirmed that low-dose ketamine have robust, rapid, and     sustained antidepressant properties. The remission of major depressive episodes has proved,     however the application during perioperative for depression symptom have not researched ever.     Thus, it is necessary to design a random-controlled clinical trail to observe the     anti-depression effect during perioperative. If ketamine can reduce the depression symptom     significantly, this treatment can be popularized in future clinical works to decrease the     rate of perioperative adverse events related of patients' depressive symptom and to enhance     the patients' long-term QOL.   "
15228|NCT03086135|"     To study the initial experience with implanting and fitting the new Bone conduction system in     patients with conductive, mixed or Single sided Sensorineural deafness.   "
15229|NCT03086122|"     The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the     general population, causing an increase in sympathetic activity, changes in systemic blood     pressure, and is associated with cardiovascular disease. The pathophysiological mechanisms     that are altered as a result of the events associated with obstructive sleep apnea     (hypoxia-reoxygenation, arousals and sleep fragmentation), are associated with an increased     risk of developing erectile dysfunction in patients with Obstructive Sleep Apnea. Until     today, the studies linking Erectile Dysfunction with Obstructive Sleep Apnea (OSA) are     epidemiological studies.      The alterations in the expression profile of endothelial and cardiovascular dysfunction     biomarkers and sex hormones disorders that are altered as a result of the events associated     with OSA are associated to erectile dysfunction development.      Treatment with continuous positive airway pressure (CPAP) reverses the effects of OSA and     patients with erectile dysfunction may improve erectile function.      The primary objective of the study is:      1. To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients.      The secondary objectives are:        1. To determine the profile of synthesis of different biomarkers related to endothelial          dysfunction and cardiovascular disorder, which are altered as a result of the syndrome          of obstructive sleep apnea and its relation to the risk of developing erectile          dysfunction.        2. To compare the secretion profile of sex hormones related to control erectile function in          a group of patients with syndrome of obstructive sleep apnea with and without erectile          dysfunction.        3. To assess the prevalence of erectile dysfunction in patients with OSA.        4. To compare the psychological profile of patients with OSA with and without erectile          dysfunction in order to detect psychological distress associated with the risk of          developing erectile dysfunction.        5. To evaluate the impact of CPAP treatment on the secretion profile of sex hormones          related to control erectile function in OSA patients.        6. To evaluate the impact of CPAP treatment on the psychological profile of patients with          erectile disfunction in OSA patients.   "
15230|NCT03086109|"     The purpose of this observational study is to investigate the prevalence and risk factors of     bone degenerative diseases   "
15231|NCT03086096|"     The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded     with Irinotecan in liver-only or liver-dominant metastatic disease in patients with     colorectal adenocarcinoma will be observed. The registry has the following objectives:        1. map the exact indications that the device is being used for and at which stage in          treatment it is being applied        2. to assess observed treatment outcomes in terms of safety and efficacy as well as trying          to determine any predictive response factors   "
15232|NCT03086083|"     Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR)     bilateral brain stimulation in trauma therapy.      A randomized, parallel, before-after, blind study was performed.   "
15283|NCT03085420|"     The purpose of this study is to collect information about how often an abnormal heart beat     happens in children who have been burned.   "
15244|NCT03085927|"     Music therapy, a frequently used arts-based therapy, has become standard palliative care in     many pediatric and adult hospitals; however, few studies have examined the mechanisms by     which music therapy interventions work. This study investigates behavioral, social, and     psychological factors that may explain how an Active Music Engagement (AME) intervention     (i.e., an interactive, music-based play intervention) works to manage emotional distress and     improve positive health outcomes in parents and young children with cancer during treatment.     Findings will provide scientific and clinically relevant practice knowledge to guide delivery     of music therapy as a complementary therapy.   "
15245|NCT03085914|"     This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic     solid tumors. Phase 1 is a dose-escalation assessment to evaluate the safety and tolerability     of epacadostat when given in combination with a PD-1 inhibitor and chemotherapy. Once the     recommended doses have been determined, subjects with advanced or metastatic CRC, PDAC, NSCLC     (squamous or nonsquamous), or any advanced or metastatic solid tumor who progressed on     previous therapy with a PD-1 or PD-L1 inhibitor will be enrolled in Phase 2.   "
15233|NCT03086070|"     The hypothesis of this study is that a gastroesophageal reflux recommended treatment with     proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the     signs and symptoms of laryngopharyngeal reﬂux and comorbid chronic rhinosinusitis. Primary     objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD)     significantly reduces the signs and symptoms of laryngopharyngeal reﬂux when compared to     placebo in patients with laryngopharyngeal reﬂux with comorbid chronic rhinosinusitis.     Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD     significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients     with laryngopharyngeal reﬂux when compared to matching placebo; and to investigate the     association of the severity of signs and symptoms of laryngopharyngeal reﬂux with the ones of     chronic rhinosinusitis in the same group of patients. The research was carried out as a     double blind randomized placebo controlled trial. Patients were randomized into two groups in     an approximate 1:1 ratio using a concealed random sequence. After randomization and initial     assessment treatment was initialized. Patients on active treatment were given omeprazole 20     mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group     were given matching placebo tablets using the same regimen for 8 weeks as the group on the     active treatment. Patients were reassessed at the end of treatment for signs and symptoms of     laryngopharyngeal reﬂux and comorbid chronic rhinosinusitis.   "
15234|NCT03086057|"     PrEPare for Work is a two-stage randomized controlled pilot trial which utilizes a     behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis     (PrEP) in Male Sex Workers (MSW).   "
15235|NCT03086044|"     This is an open-label, pilot safety and efficacy trial for adults who are active on the heart     or lung transplantation lists and are eligible to receive an organ from an increased risk     donor who has evidence of active or prior hepatitis C infection (HCV).   "
15236|NCT03086031|"     An acquired brain injury (ABI) is a complex injury often followed by a broad range of     cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities,     vocational rehabilitation (VR) is a challenging task, however, of great importance, since     approximately 75% of the patients with ABI are of working age. Thus, standardized clinically     effective and cost-effective methodologies regarding VR for patients with ABI are highly     needed.      This study is an interventional, two-arm, 6-month follow-up, cluster randomized controlled     trial involving four municipalities in the Zealand Region and the Capital Region of Denmark.     A total of 84 patients with ABI evenly distributed across four municipalities will be     included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR     intervention provided by a specialized Brain Injury Centre or the conventional VR provided by     the municipalities (usual care). The 6-9 month intervention will consist of individual and     group therapies as well as a work placement program including supported employment.     Furthermore, the intervention will include a family intervention program followed up by     support to one individual family caregiver. The primary outcomes are increased work or study     rate at 6-month follow-up. Moreover, a budget impact analysis and possibly a cost utility     analysis of the intervention will be performed The program is one of the first to include a     comprehensive and target VR intervention including multiple parties such as the     municipalities, a specialized rehabilitation team, and patients' own family caregivers. If     this intervention is proven successful when compared to the conventional VR, it will provide     evidence for a manual-based individualized holistic approach in returning to work after an     ABI.      The first hypothesis of the study is that more participants allocated to the VR intervention     group will have a significant higher employment/study rate (measured in hours) at 6-month     follow-up when compared to participants receiving the conventional VR program provided by the     municipalities (control group). The second hypothesis is that health-related quality of life     (HRQoL) and disability among the participants as well as the HRQoL and caregiver burden among     the caregivers are significantly improved at the end of the VR intervention and at 6-month     follow-up when compared to the conventional VR program. Finally, a budget impact and possibly     a cost utility analysis will be performed.   "
15237|NCT03086018|"     The aim of this study is to investigate the performance of the hearing aid under laboratory     as well as everyday conditions. In addition, the performance data of the hearing aid are     compared with a Bernafon hearing aid already available on the market.      The hearing aids are adapted according to the user requirements. The data collected in the     study is intended to show that the benefit of the hearing aid being examined is identical or     better than the current CE-marked hearing aid. A further aim is to improve the adaptation of     the hearing device in such a way that the benefit for people with hearing impairments can be     increased.   "
15238|NCT03086005|"     This study was performed to investigate the effects of metformin on controlled ovarian     stimulation (COS), in vitro fertilization (IVF) outcomes, pregnancy outcomes, and comparison     of serum and follicular fluid cytokines and hormones in patients with polycystic ovary     syndrome (PCOS) undergoing IVF using gonadotropin-releasing hormone(GnRH) antagonist     protocol.   "
15239|NCT03085992|"     This study includes patients affected by advanced and resectable rectal adenocarcinoma. It     provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by     Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed     within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free     survival at two years. Translational analyses will be performed to show the presence of VEGF     polymorphism, CD133 surface markers on colorectal CSCs.   "
15240|NCT03085979|"     Surgical management of mixed urinary incontinence   "
15241|NCT03085966|"     Study of autologous immune cell therapy in combination with the luteinizing hormone releasing     hormone agonists (LHRH-a) in patients with metastatic castration-resistant prostate cancer   "
15242|NCT03085953|"     The Study for Employment Retention of Veterans (SERVe) is a randomized controlled trial,     available exclusively to Oregon employers of veterans. It is designed to develop and     scientifically evaluate Veteran-supportive supervisor training (VSST) that may enhance     retention of veterans, with the goal of improving workplace culture and general well-being to     our service members. The intervention, applied to workplace supervisors, will be measured by     experience of veterans, assessing workplace experiences, health, well-being, as well as     employees' spouse/partners' family experiences, health and well-being, and workplace     outcomes.   "
15243|NCT03085940|"     Rheumatoid arthritis (RA) increase cardiovascular risk and endothelial dysfunction.     Hydroxychloroquine (HCQ) is expected to improve endothelial dysfunction through some     metabolic effects. The investigators intend to find the role of HCQ to improve endothelial     dysfunction in RA patients. This study will also evaluate correlation HOMA-IR (homeostasis     model assessment-estimated insulin resistance), FFA (free fatty acid) and ox-LDL     (oxidized-LDL) level change, with endothelial dysfunction improvement.   "
15284|NCT03085407|"     In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might     reduce the risk of recurrent gallstone-related complications, compared with the more commonly     used strategy in our locality of conservative management and delayed cholecystectomy.     However, evidence to support early cholecystectomy is poor, and concerns exist about an     increased risk of cholecystectomy-related complications with this approach. In this study, we     aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients     with mild biliary pancreatitis.   "
15249|NCT03085862|"     Aim. To investigate whether lung ultrasound can be used to detect extravascular lung water     (EVLW) overload in the intensive care unit early after surgery.      Methods. This prospective study involved 60 patients without known cardiac or pulmonary     diseases admitted to the intensive care unit at our hospital after elective abdominal or     vascular surgery. The inferior vena cava collapsibility index (IVCcl), oxygen partial     pressure (PaO2) and inspired oxygen pressure (FiO2) ratio (PaO2/FiO2), and appearance of     B-lines ≤7 mm were determined upon admission to the intensive care unit and at 6, 12, and 24     h later. Fluid overload was defined as IVCcl ≤ 40% and the presence of B-lines ≤7 mm. Tissue     oxygenation impairment was defined as a PaO2/FiO2 ratio < 200.   "
15250|NCT03085849|"     Primary Objectives      Dose escalation phase:      • To estimate the maximum tolerated dose of SGI-110 when given prior to durvalumab and     tremelimumab, as determined by the rate of DLT      Dose expansion phase:      • To estimate the rate of treatment related adverse events for combination therapy with     SGI-110 (at the MTD), durvalumab, and tremelimumab in order to guide phase 2 trial design      Secondary Objectives      Both phases:        -  To measure changes in expression levels of predicted neoantigens before and after          epigenetic therapy with SGI-110 by performing WES and RT-PCR on tumor biopsies        -  To estimate overall response rate (ORR), median duration of response (mDOR), median          progression-free survival (mPFS), and median overall survival (mOS) with this treatment   "
15251|NCT03085836|"     The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy     adult Chinese participants after both single and multiple dose administration.   "
15252|NCT03085823|"     The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting     Drug Coated Balloon for the treatment of any type of coronary lesions, including native     vessel disease and in stent restenosis.   "
15253|NCT03085810|"     This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates     effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will     consist of an open-label treatment period of 192 weeks and follow-up period of at least 48     weeks.   "
15255|NCT03085784|"     The ARRT trial will assess the safety and efficacy of 2mg aflibercept for the treatment of     radiation retinopathy, including maculopathy and optic neuropathy over 52 weeks.   "
15256|NCT03085771|"     The general aim of this study is to investigate the influence of systemic administration of     Desferal (Deferoxamine [DFO]) on the response to hypoxic challenge in patients with diabetes     mellitus (DM).      The investigation will elucidate if DFO can restore:        -  the impaired angiogenetic response to hypoxia in patients with type 1 DM.        -  the disturbed respiratory and cardiovascular regulation in response to hypoxia in          patients with DM type 1   "
15257|NCT03085758|"     This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and     dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic     shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.   "
15285|NCT03085394|"     Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary     sleeve gastrectomy procedures will be studied.   "
15258|NCT03085745|"     Writer's cramp (WC) is a form of focal dystonia, a movement disorder characterized by     sustained or intermittent muscle contractions causing abnormal, often repetitive movements,     postures, or both. It typically manifests while writing, making handwriting impossible in the     most severe cases. Treatment can be difficult, but one effective and well-tolerated treatment     consists in local muscle injections with botulinum toxin. Although clinical improvement seems     to be related to focal muscle chemodenervation, central plasticity changes may occur. The     main aim of the study is to characterize and quantify the changes in intrinsic hand muscle     cortical representations at rest and during isometric contractions of the finger muscles     before and after treatment with botulinum toxin and the changes in sensorimotor integration     in patients with writer's cramp.   "
15259|NCT03085732|"     The objective of this prospective randomised clinic study is to investigate the effect of     peritoneal cavity saline irrigation during abdominal hysterectomies on postoperative     infectious morbidities and gastrointestinal disturbance. The participants will be randomised     to either an irrigation of abdominal cavity or the control group after vaginal closure.     Assignment to one of the two treatment groups will be determined using a computer generated     random numbers. Primary outcome is the rate of postoperative infectious morbidities.     Secondary outcome is the rate of gastrointestinal disturbances (nausea, vomiting), use of     antiemetic drugs and pain score in the postoperative period. 100 patients in each treatment     arm planned.   "
15260|NCT03085719|"     This research study is studying immunotherapy in combination with radiation therapy as a     possible treatment for head & neck cancer that has worsened or spread to another organ or     part of your body.      The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).   "
15261|NCT03085706|"     To assess the safety of peripheral blood mononuclear cell transplantation into the     subarachnoid space for the treatment of amyotrophic lateral sclerosis.   "
15262|NCT03085693|"     Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke     is a increasing technology leading to exclusion of the left atrial appendage volume from the     blood circulation and therefore protects from cardioembolic strokes- It is unclear if the     volume reduction of the left atrium leads to a change in exercise capacity or Quality of     life.   "
15263|NCT03085680|"     This placebo-controlled RCT tests whether dietary supplementation with curcumin maintains or     improves cognitive and physical function in older adults who are at high risk of functional     decline due existing (mild) functional impairments and elevated biomarkers of inflammation     and explore the association between functional changes and changes in biological indicators     of active inflammation.   "
15264|NCT03085667|"     Closure of the LAA by several devices is a alternative therapy to oral anticoagulation in     patients with Atrail fibrillation. Nothing is known about the acute influence of a device     closure of the LAA on the secretion of ANB nad BNP hormones. Therefore aim of our study is to     measure ANB and BNP levvels before and after Implantation of an LAA closure device.   "
15265|NCT03085654|"     To examine whether multiple doses of oxytocin have different effects on behavior and neural     indices in males with high or low trait anxiety.   "
15268|NCT03085615|"     The FEDOX trial is a prospective randomized clinical trial exploring oxidative stress as a     mechanism of harm to explain the negative outcomes found in feeding trials that achieved     caloric exposure commensurate with the nationally recommended guidelines. Due to its impact     on energy metabolism, we will also explore low T3 syndrome's relationship to this mechanism.     Finally, we will explore circadian patterns of diurnal/nocturnal TSH fluctuation as a     potential biomarker to indicate this mechanism of harm has subsided.      This 7-day prospective randomized clinical trial is designed to address the following     specific aims (SA) in ICU patients (n=40) with systemic inflammatory response syndrome.      SA1) Determine whether provision of enteral nutrition (EN) at 100% of levels in Nationally     Recommended Guidelines NRG (25-30 kcals/kg, 100%NRG) early in critical illness increases     reactive oxygen species (ROS) production compared to EN at 40% of NRG levels (10-12 kcals/kg,     40%NRG). Subjects will be fasted overnight and randomized to receive either 100% NRG or     40%NRG for 7 days. Plasma F2-isoprostanes will be measured daily and compared between groups     through repeated measures analysis.      SA2) Determine if EN at 100%NRG interrupts the critical illness induced low T3 syndrome and     subsequently further increases the ROS production compared to 40%NRG. Serum thyroid     parameters (T3, T4, rT3, TSH) with be measured daily and compared between groups as above.      Mediation analysis will be used to determine the proportion of the effect of nutrition group     on F2-isoprostane production explained by each thyroid parameter.      SA3) Determine if the return of diurnal/noctural fluctuations in TSH is associated with     decreased nutrition-induced ROS production. Plasma TSH will be measured twice per day at 0300     and 1800hrs to determine TSH fluctuation. The interaction effect between TSH fluctuation and     nutrition group on F2-isoprostane production will be assessed through repeated measures     analysis. This study provides vital mechanistic insight into the impact of feeding on     oxidative stress during the first week of critical illness, represents an important first     step in determining the safest timing and dosage of nutrition support, and sets the     foundation for future larger clinical trials on these topics.   "
15269|NCT03085602|"     The purpose of this research study is to examine changes in brain regions associated with     cognitive control and reward processing during behavioral smoking cessation treatment.   "
15270|NCT03085589|"     This study aims to adapt a mobile health device (Amulet) for use in older adults. It is the     second in a series of four research studies whose overarching goal is to conduct a program of     pilot research aimed at developing and evaluating a technology-assisted wellness intervention     for older adults with obesity who may or may not live in a rural area.   "
15271|NCT03085576|"     A non-interventional, national longitudinal study of atrial fibrillation performed with 91     cardiologists.   "
15272|NCT03085563|"     The objective of this project is to compare the sedative effects of intranasal midazolam     versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency     department. The primary outcome will be length of stay (LOS) in the emergency department (ED)     stay for minor procedures. Secondarily the investigators will compare patient/family and     provider satisfaction while using either intranasal midazolam or N2O for minimal sedation.     The investigators hypothesize that the total length of stay for children undergoing minor     procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The     investigators also hypothesize that patient/family and provider satisfaction will be higher     with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients     will receive either intranasal midazolam or N2O for minor procedures. Following the     enrollment period, data will be analyzed and the two will be compared. Total length of stay,     patient/family and provider satisfaction will be studied.   "
15273|NCT03085550|"     Conventional management of diabetic ulcers is associated with slow healing, high costs and     repeated trips to clinic. Stem cells contained in fat grafts can differentiate into     pro-healing cells and release growth factors with evidence suggesting a benefit in wound     healing. Platelet-rich-plasma (PRP), an autologous blood-product, demonstrates pro-healing     properties through releasing pro-healing factors and regulating angiogenesis. When used     combination there is evidence of additional wound healing benefits.      The aim is to investigate the rate of wound healing in diabetic ulcers when treated with     conventional dressings, fat grafting alone and fat+PRP combination. The secondary aims will     be to understand the mechanism of the healing process, the health related quality of life and     patient satisfaction and the cost implications.      The study is a single-blinded randomised controlled trial of 30 patients with three parallel     treatment arms. Each patient will be followed up for 12 weeks and the rate and degree of     wound healing will be assessed. Wound biopsies will be taken at Day 0, week 1 and week 4 and     will undergo subsequent histological analysis to evaluate the mechanism of healing. The study     is expected to last two years from recruitment of the first patient and will be conducted at     Royal Free Hospital and UCL Division of Surgery and Interventional Science.      The combination of fat+PRP may provide diabetic patients the option of a single treatment     with improved healing, shorter followup and a reduced cost burden. Validation of the     mechanism of healing through histological analysis will confirm clinical findings and help     guide future research.   "
15274|NCT03085537|"     The main objective will be to determine the effectiveness of home non-invasive ventilation by     flow-time and time-pressure curves analysis in a cohort of patients with this treatment by     digital diagnosis platform.   "
15275|NCT03085524|"     The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery     disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the     risk of amputation, in the absence of revascularization, is high. No trial conducted to date     in peripheral revascularization has determined the effect of diabetes on mechanism of     revascularization failure. Therefore, this trial represents a unique opportunity to     investigate the mechanisms by which diabetes affects surgical and endovascular     revascularization procedures with the long-term goal of improving outcomes in CLI.   "
15276|NCT03085511|"     The purpose of this study is to determine if, in presence of a reduced calorie diet, a     breakfast containing high quality protein source (eggs) would be more effective in reducing     hunger and increasing feeling of fullness compared to a breakfast containing a lower quality     of protein, but equal energy density. A previous pilot study with the same endpoints yielded     borderline significant results; this study has been powered based on that pilot to     interrogate our hypotheses.   "
15277|NCT03085498|"     The study resembles a four-year follow-up on the influence of physical activity and fitness,     blood pressure, BMI and stress on vascular health in primary schoolchildren. It examines the     predictive value of retinal vessel diameters for the development of childhood hypertension.   "
15278|NCT03085485|"     The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor     (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis,     and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot,     randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40     subjects with COPD will be randomized.   "
15485|NCT03082781|"     The present study aimed to determine the effects of negative-calorie diet supplemented with     exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie     diet with exercise among elderly adult women with abnormal weight gain.   "
15279|NCT03085472|"     The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational     study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be     the senior consultant for the study. The Chongqing intracerebral hemorrhage study will focus     on the epidemiology, natural history, pathogenesis, laboratory, radiological aspects,     clinical outcomes and the effects of treatment in patients with intracerebral hemorrhage.      The clinical, laboratory, imaging, genetic and outcome data of patients diagnosed with acute     intracerebral hemorrhage will be prospectively collected. The prognosis of patients with     intracerebral hemorrhage will be assessed by using several outcome measure scales at     different time points.   "
15280|NCT03085459|"     A retrospective, observational study was performed about the patients with septic shock who     admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number     of patients who received empiric antibiotic treatment within first hour after septic shock     diagnosis were collected. Detailed information about clinical ladder for nursing stuff and     nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on     education background and work experience and nurses stuff are classified into four levels. N0     was defined who got college degree or above, nurse qualification certificate and working time     less than one year. N1 an N2 were defined as who got nurse qualification certificate and     working time between 1~3 years and more than three years, respectively. N3 was defined who     was nurse-in-charge qualification or got nurse practitioner qualification for more than five     years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect     of nursing stuff on the compliance were calculated.   "
15281|NCT03085446|"     Insomnia is a chronic mental health condition characterized by difficulty initiating and     maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is     associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor     mental health (e.g., anxiety and depression), functional limitations, and cognitive decline.     Available pharmacological and behavioral treatments focusing on reducing nighttime     hyper-arousal offer limited success, and it appears that there is no one size fits all     treatment for late life insomnia. Mounting evidence suggests that sleep is related to     metabolic status, however, studies on the associations between sleep and dietary patterns are     surprisingly scarce.      The ability of gut microbiota to communicate with the brain is emerging as an exciting     concept in health and disease and provides the rationale for the present project. Findings     demonstrate that gut microbiota modulates mental capacities such as brain plasticity and     cognitive functions in older adults, as well as stress related mental illness. The     composition of the intestinal microbiota in older people (>65 years) differs from the core     microbiota and diversity levels of younger adults. With age, gut populations of beneficial     microbes show a marked decline. As diet has been shown to markedly promote microbiota     biodiversity, it is hypothesized that diet-induced changes in microbiota may provide a novel     approach for the treatment of mental health. Although insomnia is strongly linked to mental     health (e.g., depression and anxiety), as well as cognitive and motor performance, the     effects of diet-induced microbiota alterations, based on individual microbiota composition,     on late life insomnia is currently unknown.      The proposed project will be the first to investigate the associations between gut microbiota     and sleep, and assess the potential of a six-months personalized, diet-induced microbiota     alterations intervention (PDM), aimed to improve insomnia in older adults. We will also look     at cognitive, motor and mental health factors as possible mediators in this relationship.     Specifically, we will test the associations between microbiota composition and sleep quality,     both cross-sectionally and longitudinally, i.e., following a PDM intervention; evaluate the     impact of PDM on changes in cognitive, motor and mental health functions; and identify the     mediating roles of changes in cognitive, motor and mental functioning on the effects of a PDM     intervention on sleep quality. Findings are expected to improve the quality of life of older     adults by enhancing their sleep, functional status, mental health and overall wellbeing.   "
15289|NCT03085342|"     As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is     often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive     methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able     to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with     different stage using multiparametric MRI with emphasis on portal flow measurement.   "
15290|NCT03085329|"     This study is designed to test the hypothesis that among infants born at less than 30 weeks,     weighing less than 1500 g at delivery, and receiving initial respiratory support     non-invasively or on invasive respiratory support and meeting extubation criteria in the     first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal     intubation and conventional mechanical ventilation (CMV) than will neonates managed from     birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- &     Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the     delivery room or who are stabilized on mechanical ventilation as their initial form of     respiratory support and meet our criteria for extubation within 72 h of birth will be     eligible for randomization and study.      The primary endpoint of this study is the cumulative incidence of respiratory failure     requiring intubation that occurs in patients after randomization and before 36 weeks post     menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports     that this age group typically exhibits intubation rates of 50% or more, which is consistent     with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU)     Neonatal Intensive Care Unit (NICU).   "
15291|NCT03085316|"     Standard treatment options for patients who are diagnosed with BVFP include tracheostomy,     cordotomy, arytenoidectomy, and suture tie-back. These standard treatment options may result     in permanent damage to the vocal fold, therefore affecting the patient's ability to speak and     compromising airway protection during swallowing. Additionally, these routine procedures     cannot provide sufficient airway to permit significant aerobic activity. The goal in     conducting this early feasibility study is to investigate the use of this device as a     laryngeal pacemaker to treat BVFP.   "
15292|NCT03085303|"     Multicentric, placebo‐controlled, double‐blinded, three‐armed, prospective, randomized     controlled trial.150 patients diagnosed with atopic dermatitis will be randomized to arm 1     (irradiation for 30min at 415nm wavelength), arm 2 (irradiation for 30min at 450nm     wavelength), and arm 3 (irradiation for 30min at low‐dose (placebo)). Irradiation will be     scheduled 3 times a week for 8 weeks. Patients will be followed up for four weeks after the     last irradiation.   "
15303|NCT03085160|"     Research suggests there is a connection between mood and weight. People who feel stressed or     depressed are more likely to be overweight than people who don't have these feelings. Some     individuals turn to food to cope, which can lead to gaining too much weight over time.     Adolescence is an important time to understand these connections. Patterns of handling stress     learned during adolescence set the stage for stress management in adulthood. This study is a     randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic     obesity. The investigators will test if taking part in a 6-week group program to lower stress     and improve mood will be helpful to teens at-risk.   "
15486|NCT03082768|"     The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1     receptor targeted radiopharmaceutical.   "
15293|NCT03085290|"     Serum eye drops (SEDs) are used to treat patients with extreme dry eyes and other corneal     defects. Serum is used in severe ophthalmic cases where conventional eye drops (artificial     tears) have insufficient effect. The use of SEDs in dry eye patients usually has a rapid     effect. Most patients claim the effect to be instantaneous, and all symptoms improve within     48 hours.      There is evidence suggesting that substances in serum may help in the healing of epithelial     defects, such as epidermal growth factor, fibroblast growth factor, fibronectin, and/or     vitamin A. However, the precise serum factor responsible for alleviating the patient's     complaints is currently not known. Commonly, autologous SEDs are used, but they are replaced     more and more by allogeneic SEDs prepared from donor serum.      Allogeneic SED are derived from healthy voluntary, non-remunerated male donors with blood     group AB. The use of allogeneic SED could provide blood bank controlled quality, a safer     product in larger quantities that is quickly available for each patient.      No double-blind randomized trials are known to exist to detect a difference in result between     the effect of allogeneic SED or autologous SED. This pilot study is intended to obtain     insight in the ability of autologous and allogeneic SEDs to improve patient dry eye     sensation. Our hypothesis is that autologous SEDs (in a 1:1 dilution with saline) result in     an improvement of the patient dry eye sensation, while allogeneic SEDs (in a 1:1 dilution     with saline) do not.   "
15294|NCT03085277|"     Feeding intolerance is a common problem in very preterm infants due to their immature     digestive system. This intolerance extends the time to full enteral feeding and thereby also     prolongs the time on parenteral nutrition (PN). Prolonged time to full enteral feeding may     predispose these infants to a higher risk of growth retardation, infections and organ     dysfunctions (e.g. liver, brain). Mother's own milk (MM) is considered the optimal nutrition     for preterm infants and is superior to infant formula (including preterm formula, PF) in     stimulating gut maturation, feeding tolerance, resistance against necrotizing enterocolitis     (NEC) and late-onset sepsis (LOS), and long-term neurodevelopmental outcomes. However, MM is     often absent, or not available in sufficient amounts, during the first days or weeks after     preterm delivery. Human donor milk (DM) is probably a better supplement to MM than PF, but DM     is not available for all hospitals. To supplement insufficient MM during the early neonatal     period in hospital settings with no access to donor milk, we suggest that bovine colostrum     (BC) may be used instead of PF for very preterm infants during early life. BC, the first milk     from cows after birth, is a rich source of protein and bioactive components, including     lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and various growth factors, such as     IGF-I and -II, EGFs, and TGF-β. BC has repeatedly been shown to improve gut maturation and     NEC/LOS resistance in a well-established piglet model of preterm infants. We suggest a     randomized, controlled trial to investigate the effects of BC vs. PF, supplemented to MM     during the first 2 weeks, on the time to full enteral feeding in very preterm infants.   "
15295|NCT03085264|"     This study focuses on pairing community health workers (CHWs) with patients that are high     risk for readmission prior to hospital discharge in order to assess differences in hospital     readmission rates, ED visits, patient satisfaction and provider satisfaction as compared to     patients without community health worker pairings at discharge.   "
15296|NCT03085251|"     The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015     (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures     for blood glucose monitoring systems intended for self-monitoring of blood glucose by     patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European     Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and     procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In     this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan     Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system     lots.   "
15299|NCT03085212|"     The purpose of pilot study application is to build on the investigators' previous work that     established the prospective association between stress and infertility. Specifically, the     investigators hope to collect the preliminary data necessary to make them competitive to     submit a R01 application to NIH for funding of a full-scale randomized controlled trial of an     internet-based stress management program to examine its efficacy in decreasing stress and     increasing pregnancy rates among women who have tried to get pregnant for 6-12 months without     success. The program called Stress Free Now (SFN) was developed at the Cleveland Clinic and     has been shown to be effective in lowering stress in a variety of populations. The program     introduces concepts of mindfulness and cognitive-behavioral therapy to assist individuals in     managing their stress levels. The intervention includes Internet-based interaction, daily     emails and recommended relaxation practice of at least four days per week. Using targeted     Facebook Ads and other recruitment modalities, the investigators will randomize 40 women ages     18-34 who have been trying to conceive for 6-12 months without success. The PI has been     enrolling women in a similar study using this mechanism and has found it to be an efficient     and cost-effective method of identifying potentially eligible individuals. Women will be     randomized to SFN or a wait list control condition and will be followed for up to three     months post-randomization with weekly journals as they try to conceive. The primary outcome     of this randomized controlled trial is stress level, as measured by salivary alpha-amylase,     while the secondary outcome will be pregnancy rate at the end of the three-month follow-up     period.   "
15300|NCT03085199|"     Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or     open gastrectomy for gastric cancer patients has been conducted.      We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line     of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a     prospective phase II study was designed for safety of this technique.   "
15301|NCT03085186|"     Two year old male with a new diagnosis of Inflammatory Myofibroblastic Tumour. The patient     presented with 2 months of intermittent fever and 1-2 weeks of abdominal distention and     constipation. An abdominal mass was palpable on exam and US concerning was for neoplasm of     abdomen.      Treatment with Crizotinib will be utilized to reduce the size of the lesion and create more     optimal tissue plains between vital structures prior to attempted surgical resection would     greatly reduce potential morbidity for this patient.   "
15920|NCT03077100|"     To aim of this study is to identify the pathogens and their distribution in the NICU and to     determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit.   "
15304|NCT03085147|"     The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used     to detect this type of cancer. This will be the first time that PARPi-FL is being tried in     people. First, the investigators will test the safety of PARPi-FL at different doses to find     out what effects, if any, it has on people. The investigators will also see which amount of     PARPi-FL is best suited to detect cancers of the mouth and tongue.   "
15305|NCT03085134|"     The primary objective of the study is to show that infants with cow milk protein allergy     (CMPA) fed with a new FSMP infant formula with reduced level of protein & with 2 Human Milk     Oligosaccharides (HMOs) (test formula) have a growth in line with infants fed with a     comparable FSMP formula but without HMOs (control formula). The secondary objectives are to     assess whether consumption of Test formula by CMPA infants (i) reduces medication use and     risk for infections in particular lower respiratory tract infections/morbidity, (ii) is well     tolerated and allows for age appropriate growth and (iii) reduces health care costs.   "
15306|NCT03085121|"     A prospective study will be performed to compare the clinical outcome after total knee     arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an     intramedullary system. The extramedullary femoral alignment system is newly designed. These     two systems are used to make the distal femoral resection in 100 patients in a random order.   "
15307|NCT03085108|"     The main purpose of this cross-sectional study is to generate data to support the     psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and     validate its use in participants at imminent risk of suicide.   "
15308|NCT03085095|"     The purpose of this study is to determine the benefit and safety of relugolix 120 mg once     daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (<=50     ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer.   "
15309|NCT03085082|"     the study is searching if there is a relationship between the blood groups and RH and the     skeletal malocclusion using the skeletal class I as a control group   "
15310|NCT03085069|"     This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1     antibody) as second-line therapy in in adult Chinese patients with advanced or metastatic     non-small cell lung cancer who failed or progressed to prior first-line systemic treatment.      Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor     cells(<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose     (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the     clinic once every two weeks. Radiographic disease assessments will be performed every 6     weeks.      The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate     when compare with standard of care (SOC), no matter how much PD-L1 expression in tumor.   "
15311|NCT03085056|"     The purpose of this study is to test the safety and tolerability of this treatment     combination of paclitaxel and trametinib. Additionally, this study aims to to find out what     effects the combination of paclitaxel and trametinib has on the shrinkage and growth of     anaplastic thyroid cancer.   "
15312|NCT03085043|"     The goal of this clinical research study is to compare 2 different types of magnetic     resonance imaging (MRI). Researchers will compare diffusion-weighted imaging (a method to     show how water moves in a certain area) with standard-of-care imaging to learn which method     is better to check the status of prostate cancer.   "
15313|NCT03085030|"     The aim of the study is to evaluate the effect of antioxidants on IVF outcome in infertile     patients undergoing IVF who are expected to produce low number of eggs compared to a control     group. The investigators assumed that the conception rate is higher in those patients taking     some antioxidants supplementation. The patients will be given antioxidant drug one month     before starting IVF trial once daily by mouth. Uniform protocol of stimulation will be done     during the cycle by a type of short protocols known as the antagonist protocol. Egg retrieval     will be done under anesthesia. pregnancy test will be done 2 weeks after embryo transfer. The     investigators will also assess the number and quality of eggs on the day of egg pick up. In     addition, the researchers will assess the number of first and second grade embryos that are     put on the day of embryo transfer.   "
15314|NCT03085017|"     A prospective randomized open-label study that will evaluate the effectiveness of the pliable     and absorbable bone hemostats (BoneSeal®) on the reduction of bleeding from the sternal bone     marrow in patients undergoing cardiothoracic surgery.   "
15315|NCT03085004|"     The purpose of this study is to evaluate the efficacy of chemotherapeutic pancreatic cyst     ablation using ethanol lavage followed by the infusion of a single agent chemotherapeutic     agent (paclitaxel) compared with alcohol free, saline lavage followed by infusion of a     multi-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of     pancreatic cystic neoplasms using endoscopic ultrasound fine needle infusion (EUS-FNI) for     agent delivery. The ultimate purpose os a safe and more effective EUS-FNI , method to     eliminate there pre cancerous cyst and prevent a significant percentage of pancreatic cancer.   "
15316|NCT03084991|"     The purpose of the study is to investigate the clinical outcomes, safety and     cost-effectiveness of intravascular OCT imaging in patients with STEMI undergoing primary     PCI.The study will enrolled about 4500 STEMI patients(1500 with OCT and 3000 without OCT     during primary PCI）in 20 sites of China. The total duration of the study is expected to be 5     years, 2 years for enrolment and 3 years for total follow up.   "
15317|NCT03084978|"     This is a randomized controlled trial investigating the effect of general anesthesia versus     conscious sedation on operative times in patients undergoing transcatheter aortic valve     replacement.   "
15318|NCT03084965|"     Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in     Taiwan   "
15319|NCT03084952|"     It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability,     safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis     treatment.   "
15320|NCT03084939|"     This is a Phase III, randomized, multicenter, two-arm, open-label study designed to evaluate     the safety and efficacy of trastuzumab emtansine compared with that of lapatinib +     capecitabine in Chinese participants with HER2-positive, unresectable locally advanced breast     cancer (LABC) or metastatic breast cancer (MBC) who have received prior trastuzumab-based     therapy. A total of approximately 400 participants will be enrolled in China. Eligible     participants will be randomized in a 3:1 ratio to receive either trastuzumab emtansine or     control (lapatinib + capecitabine).   "
15321|NCT03084926|"     This study is investigating a new experimental therapy, MP0274, a DARPin® drug candidate     targeting HER2. Preclinical studies suggest that MP0274 may provide additional benefit for     the treatment of HER2-positive cancers. This is the first study of MP0274 in humans and its     main purpose is to test its safety and tolerability in patients with HER2-positive cancer.     This study will also examine the blood levels of MP0274 at several escalating dose levels and     a recommended dose for further development will be determined. The recommended dose will be     tested in a second part of the study to confirm safety and to further assess the preliminary     biologic and anti-tumor activity   "
15322|NCT03084913|"     This study compared a plant-based, olive oil diet to the diet recommended by the Prostate     Cancer Foundation for weight loss and improvement in some laboratory biomarkers.   "
15323|NCT03084900|"     Investigators propose to study an intervention that will provide patient-centered, automated     decision support to diabetes providers with the goals of improving adherence to medical     recommendations (both patients and providers), improving self-management, and ultimately     improving health outcomes.   "
15324|NCT03084887|"     Reduce the common complications incidence about patients placed tissue expansion devices to     around 5%.   "
15325|NCT03084874|"     Patients with COPD are more inactive and more sedentary than subjects of the same age and     patients with other chronic diseases. This inactivity and sedentary behavior is accentuated     after hospitalizations due to a COPD exacerbation, and it increases the risk for future     hospitalizations and mortality. Therefore, there is a need for intervention to promote     physical activity and to reduce sedentary behavior after these events. The present study aims     to evaluate the efficacy of a coaching program to promote physical activity and reduce     sedentary behavior in patients with COPD who have suffered a hospitalization due to a COPD     exacerbation. Sixty-six COPD patients admitted to the hospital will be recruited during 18     months. Physical activity, sedentary behaviors, as well as other clinical and functional     parameters will be evaluated after hospital discharge. Patients will be then randomized to an     intervention and control group (1:1). The intervention group will receive an individualized     coaching program. During a motivational interview an experienced physiotherapist will asses     participant's usual exercise habits, possible barriers and facilitators, self-efficacy and     motivation to increase physical activity and reduce sedentary time. Based on these data (and     baseline physical activity/sedentary information) an individualized, progressive program with     specific goals setting and self-monitoring will be established (patients will be active     participants and decision makers in this process). The control group will receive the usual     care during follow-up. Physical activity, sedentary behaviors, as well as the clinical and     functional variables will be evaluated again at 12 weeks in both patients' groups.   "
15326|NCT03084861|"     This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which     42 patients will be enrolled with the principal objective to evaluate the efficacy through     changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal     sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy     (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye     drops) or conventional treatment (artificial tears and therapeutic contact lens).   "
15327|NCT03084848|"     The purpose of this study is to investigate the cognitive and brain effects of inhibitory     control (IC) training at adolescence.   "
15328|NCT03084835|"     This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that     links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based     program and integrated text messaging. The goal is to provide actionable findings about how     to most effectively and cost efficiently promote abstinence in LDCT clinics.   "
15329|NCT03084822|"     Given the importance of healthy lifestyle practices to cardiovascular disease (CVD)     prevention and the utility of church-based interventions in African-American adults, the     investigators developed a theory-informed, strategically-planned, health and wellness     intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN)     churches with predominately African-American congregations. The objective of the study was to     partner with churches to implement a multi-component, health education program through the     use of core educational sessions delivered through a digital-application accessible on demand     via interactive access on computer tablets and the Internet. The overarching goal was to     increase the awareness and critical importance of healthy lifestyles for CVD prevention and     provide support for behavior change.   "
15330|NCT03084809|"     Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators     aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of     postoperative colorectal cancer patients. And to provide useful reference for the clinical     application of CIK in colorectal cancer patients.   "
15331|NCT03084796|"     The purpose of this study is to evaluate the dose-response of different doses of CHF 5259     pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms     of benefit/ risk ratio for further development in the target subject population.   "
15332|NCT03084783|"     Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It     usually happens as a direct result of virus, such as herpes simplex virus (HSV).      HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the     growth and spread of HSV in the body). Despite this however, around 2 out of every 3 people     will have memory difficulties long term. Dexamethasone is a corticosteroid medication, which     works by preventing the release of natural chemicals in the body which cause inflammation. It     is possible that dexamethasone could help to reduce in swelling of the brain may improve the     recovery of patients with HSV encephalitis. The aim of this study is to find out whether     treatment with dexamethasone can improve long-term health outcomes in adults with HSV     Encephalitis.   "
15333|NCT03084770|"     The aim of the study is to evaluate the most appropriate management of sporadic asymptomatic     non-functioning pancreatic neuroendocrine neoplasms (NF-PNEN) ≤ 2 cm. P NF-PNEN management     will be decided at the hospital and all therapeutics decision will be decided/coordinated by     the treating physician.      Patients will be either submitted to surgical resection or to active surveillance.   "
15515|NCT03082391|"     The purpose of this study is to determine if mesh weight has an impact on postoperative pain,     ventral hernia recurrence, incidence of deep wound infection, and overall quality of life     following ventral hernia repair with mesh.   "
15334|NCT03084757|"     The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling     versus conventional chemotherapy in patients with advanced cancer using each patient as its     own control. This study is a study involving patients with advanced cancer. All types of     solid tumors will be allowed in the study.   "
15335|NCT03084744|"     To compare the efficacy of schema therapy versus active monitoring for women with chronic     depression receiving psychiatric care.   "
15336|NCT03084731|"     Burden: According to Bangladesh Demographic Health Survey 2014, prevalence of stunting in     under-five children is 36%. Severe acute malnutrition (SAM) is prevalent in about 3% of them.     In absolute numbers, about 450,000 children suffer from SAM while several million children     suffer from moderate acute malnutrition (MAM).      Knowledge gap: Investigators have already demonstrated that children with SAM have immature     gut microbiota that is partially corrected with treatment. Through our earlier studies     conducted in Bangladesh,investigators now also have idea about beneficial microbiota and food     ingredients that support proliferation of these beneficial microbiota. Which composite food     is better for children with SAM and MAM is not known.      Hypothesis (if any): The central hypothesis of our ongoing Breast Milk, Gut Microbiome and     Immunity (BMMI) initiative proof of concept phase is that healthy growth in infancy and early     childhood requires normal functional maturation of the gut microbiota. Related hypotheses are     that (i) persistent defects in the development of this microbial 'organ' are causally related     to stunting as well as the metabolic, immunologic and cognitive manifestations of     undernutrition; and (ii) new approaches for durable repair of this microbiota immaturity     including Microbiota-Directed Complementary Foods (MDCF) will provide a way to improve     clinical outcomes.      Objectives:        1. Test 5 MDCF prototypes and nominate a lead MDCF formulation that has the greatest effect          in promoting the representation of a broad range of age-discriminatory taxa and that has          acceptable organoleptic properties. This nominated lead will be advanced to a fully          powered clinical POC study in children with post-SAM MAM in 2018.        2. Determine whether once daily administration is as effective as twice daily          administration of the lead MDCF in repairing microbiota immaturity.        3. Assess the durability of repair of immaturity by the lead MDCF by including a 4 week          post-intervention phase in the final pre-POC study design.        4. Determine what effect enteropathogen burden (determined by PCR-based analysis of fecal          samples) has on responses of age-discriminatory taxa to MDCFs, and reciprocally, the          effect of MDCFs on enteropathogen burden.      Methods:      Investigators will conduct 3 Pre-POC studies in 12-18 month old children with MAM     (Weight-for-Length Z-score, WLZ: between <-2 to -3) and stunting (Length-for-Age Z-score,     LAZ: between <-2 to -3) over the course of approximately two years. The investigators will     use a stratified randomization procedure based on age (i.e.2 levels: 12-15 months and >15-18     months) to prevent imbalance between the treatment arms. This study will be undertaken at     Mirpur area of Dhaka city. The investigators will design and produce 5 MDCF prototypes at the     icddr,b Food Processing Laboratory in sufficient quantities for clinical studies (3 MDCF     prototypes for study 1 and 2 MDCF prototypes for study 2). These formulations will be matched     in energy density and micronutrient content of ready-to-use supplementary foods (RUSFs) used     for MAM in Bangladesh and other countries, and will meet all other requirements for a     complementary/supplementary food for 12-18 month old children with MAM and stunting.   "
15337|NCT03084718|"     The purpose of this study is to evaluate the dose-response of different doses of CHF 781 pMDI     on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of     benefit/ risk ratio for further development in the target patient population.   "
15338|NCT03084705|"     The goal of this study is to determine the effectiveness of interactive feedback from a     wearable device that senses hand function, the Manumeter, in improving upper extremity     function in a pilot, randomized controlled trial with chronic stroke patients   "
15339|NCT03084692|"     The purpose of the study is to determine the feasibility and preliminary efficacy of a     combined therapeutic yoga and resistance exercise intervention for individuals with lung     cancer and their caregivers. The investigators aim is to help reduce the fear of exercise by     tailoring the program to meet the specific needs of the survivor with lung cancer. The     investigators want to see whether individuals with lung cancer and their caregivers are     interested in participating in this type of program, and if they are able to attend the     intervention sessions and complete the program. The investigators also plan to study the     preliminary effects of therapeutic yoga and resistance exercise on fitness outcomes for both     individuals with lung cancer and their caregivers.   "
15340|NCT03084679|"     The investigators hypothesised that novel MRI metrics derived from myocardium post-gadolinium     T1 mapping analysis will improve the current knowledge about the role interstitial fibrosis     and cardiomyocyte hypertrophy in the development of left ventricular (LV) remodelling and     clinical Heart Failure (HF). The investigators believe that these recently described     variables will be associated with prognostically important indices in HF development.   "
15375|NCT03084224|"     For some neurological and neurodegenerative diseases genetic inheritance is well documented     (described as Mendelian or multifactorial), but sometimes specific mutations or family     segregation evidences have not been identified. Considering this scenario, most of the times     it is impossible or unlikely to identify the responsible gene, or the private mutation, of a     patient affected by a neurodegenerative disease.      New technologies such as Next Generation Sequencing (NGS), allow the analysis of hundreds of     genes in a single experiment. The implementation of these technologies will help to identify     new genes and new variants associated with neurological diseases. Using this approach,     several molecular genetic diagnosis will definitely find the needle in a haystack, and will     be able to be used in the clinical practice.   "
15341|NCT03084666|"     In this study, patients undergoing live donor kidney transplantation will be allocated to the     control group or remote ischemic preconditioning group (RIPC). RIPC is the utilization of     short periods of ischemia to provide protection of the myocardium or other organ (i.e.     kidney) from a subsequent ischemic event. Before allograft implantation, RIPC will be     accomplished in the recipient and donor by inducing intermittent extremity ischemia through     intermittent inflation of an extremity tourniquet three times for five-minute intervals with     five minutes of deflation between inflation periods. The monitored clinical end points will     include total urine output following kidney reperfusion over five days, plasma creatinine     declination over five days, initiation of dialysis, and development of graft injury.     Magnitude of graft injury is the primary endpoint and will be measured using biochemical     markers, such as, plasma and urinary concentration of neutrophil gelatinase associated     lipocalin (NGAL), IL-18, and KIM-1. The sample size calculation is based on a projected     difference of NGAL levels between the two study arms. Hall et al reported a mean NGAL level     of 49 mg/mL (SD = 37 mg/mL) for a group of patients that had immediate graph function and a     mean NGAL level of 248 mg/mL in a group of patients with slow graft function. (which Hall     reference is this) Based on these data, a conservative estimate of a mean difference between     study groups will be considered 35 mg/mL NGAL. Using these assumptions, an alpha level of     0.05 and 80% power, a sample size of n= 19 per study group will be calculated. By rejecting     our null hypothesis, RIPC may serve as a safe, cost-effective protective strategy to prevent     allograft injury in the clinical setting of live donor kidney transplantation.   "
15342|NCT03084653|"     Several techniques for initial abdominal entry in laparoscopy have been introduced in     literature. Various guidelines and recommendations are available on this subject, however,     compliance to these are controversial. The purpose of this study is to evaluate the rationale     and the process of decision making for first entry technique in laparoscopy.   "
15343|NCT03084640|"     CMP-001-002 is a Phase 1b study of CMP-001 administered either subcutaneously (SC) or     intratumorally (IT) followed by subsequent SC administration, in combination with     Pembrolizumab in subjects with advanced cutaneous melanoma who are either receiving     Pembrolizumab, or who have previously received an anti-PD-1/PD-L1 therapy for advanced     cutaneous melanoma, and who have not responded (i.e. immunotherapy resistant).      This study will be conducted in two parts:      Part 1 will consist of a Dose Escalation Phase and a Dose Expansion Phase of CMP-001        -  Dose Escalation Phase will be conducted to assess and identify a recommended phase 2          dose (RP2D) for SC administration.        -  The Dose Expansion Phase is intended to further characterize the safety,          pharmacodynamics, and preliminary evidence of antitumor activity of the RP2D of CMP-001          administered SC in combination with Pembrolizumab.      Part 2 will assess the safety and preliminary evidence of antitumor activity of CMP-001,     administered IT for 3 weekly doses, followed by CMP-001 SC dosing every 3 weeks (q3wk), when     given in combination with Pembrolizumab.   "
15359|NCT03084432|"     The primary objective was to determine whether caffeine therapy is associated with decreases     bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to     determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis     or bone fracture.   "
15547|NCT03081975|"     The aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and     surveillance colonoscopies.   "
50454|NCT02625181|"     The purpose of this study is to determine how automated recommendations are best presented to     optimize the adherence to guidelines on prophylaxis for nausea and vomiting after surgery.   "
15344|NCT03084627|"     Pregnancy is associated with an increase in nutrient requirements. During this period, women     would be keener on adopting healthier behaviors. Thus, pregnancy represents an opportunity to     improve the nutrient adequacy of the diet of mothers-to-be. This study is a randomized     controlled trial, which aims at evaluating the efficiency of a tailored dietary advice tool     in improving the nutrient adequacy of the diet of pregnant women, as measured by the PANDiet.     Eighty pregnant women will be included in the study and randomized either in the control     group, or in the intervention group. The control group will receive generic dietary advice     based on a booklet edited by the French Institute for Health Promotion and Health Education     (INPES). The intervention group will receive the same generic dietary advice plus tailored     dietary advice to improve the nutrient adequacy of their observed diets. Dietary intakes will     be evaluated online using a 3 days food record, at baseline and 6 weeks after patients     received the booklet and/or the first tailored dietary advice. Thus, the nutrient adequacy of     the diet could be evaluated before and after the intervention in both groups.      The dietary follow-up for one patient will last 12 weeks only, but data will be collected at     delivery.      Moreover, after, the 12-week dietary follow-up and before their deliveries, 10 participants     (5 by group) will be contacted to participate in a qualitative interview. This interview will     aim at understanding barriers and motivators to implement dietary advice (generic and/or     tailored) in the diet of pregnant women in the study.   "
15345|NCT03084614|"     Background:      When a person is exposed to something that causes an infection, the body sends a type of cell     called CD8 T cells to attack it. Those cells are also found in breast milk. Nursing mothers     pass these cells to their child, which helps the child fight infections, too. Researchers     want to learn more about how CD8 cells work to keep people healthy.      Objective:      To learn more about how the human body fights off infections.      Eligibility:      People age 18 years and older who either have an infection, are suspected to have an     infection, or recently got a vaccine.      The household contacts of these people and people who have not been recently exposed to any     infection are also needed.      Design:      Participants will be screened with a medical and health history and physical exam. They may     have blood tests.      The first study visit can be the same day as screening. It can be up to 3 months later. For     those visits, screening tests will be repeated.      At the first visit, participants will have blood collected from an arm vein.      Participants who are breastfeeding may provide a small sample of breast milk. They may     collect it at home or bring a pumping device to NIH to collect it. NIH can also provide a     breast pump.      Participants may be contacted for up to 1 year after the first visit to give samples of blood     and/or breast milk.      Up to 4 additional visits, which will each take about 1 hour, may be scheduled.      A personal physician or local lab can collect blood from participants and ship it to NIH.     Breast milk cannot be shipped.   "
15346|NCT03084601|"     The aim of the current study is to compare a newly introduced material which is a combination     of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is     named 3MIX-TATIN & will be compared to triple antibiotic paste for management of necrotic     primary molars by using lesion sterilization and tissue repair LSTR technique.   "
15389|NCT03084042|"     This study aims to 1) examine common and specific emotional and cognitive dysfunctions     between Major Depression and generalized anxiety disorder; 2) Examine emotional and cognitive     dysfunctions between the two disorders and healthy controls; 3) Examine the biomarkers     predicting successful therapy or not.   "
15347|NCT03084588|"     Patients undergoing shoulder surgery may experience moderate-to-severe pain during the first     2-3 days following the operative procedure. Two methods are used to control pain in the early     postoperative period. First, an interscalene nerve block (ISB) can be placed prior to surgery     to block the pain fibers that supply the shoulder. Although an ISB provides effective     analgesia for several hours after surgery, the block is associated with the potential for     transient or permanent nerve injury. Furthermore, the ISB can wear off suddenly, resulting in     the abrupt onset of severe pain. A second method of pain control involves the use of opioids.     Opioids can provide potent pain relief following surgical procedures. However, the agents     that are commonly used by anesthesiologists and surgeons only produce pain relief for 2-4     hours, which leads to fluctuations in the levels of pain control. Recent data suggest that     the use of a long-acting opioid like methadone in the operating room, which provides     analgesia for 24-36 hours, may improve pain control after surgery. The aim of this clinical     trial is to compare postoperative pain scores and analgesic requirements in patients     randomized to receive either an ISB or methadone at the start of shoulder arthroscopic     surgery.   "
15348|NCT03084575|"     The control of perineal malignant pain is difficult and challenging for pain physicians.     Different modalities have been tried to treat this complex pain syndrome including     pharmacotherapy and interventional therapy.      Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or     rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical     recomendations of selective sacral nerve roots rhizotomy blockade as an alternative to     chemical saddle rhizotomy.   "
15349|NCT03084562|"     Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle     function. This examination takes place in two stages, one imaging at rest and one after a     cardiac stress caused. This stress can be triggered as a first-line stress test. A     pharmacological stress is proposed when stress test is not possible or contraindicated,     Several drugs have a marketing authorization in this indication (adenosine, dipyridamole,     regadenoson, dobutamine).      Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it     would allow a reduction of undesirable effects compared to other agents, especially     adenosine. It is simple and quick to use thanks to a single dose administration. However, its     cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole     is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for     a limited number of doses, the indication of which must be justified (asthmatic patient or     with severe COPD). Few studies in the literature specifically compare these two     pharmacological agents (examination time, cost, tolerance) and the opinion on the use of     regadenoson in the service is limited.   "
15407|NCT03083808|"     This is a single-arm phase II study of continuation immunotherapy with pembrolizumab     following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor.   "
15350|NCT03084549|"     Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In     postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and     persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain     during labor or following a caesarean section. The perineal pain associated with the     realization of an episiotomy has been much less studied and often undervalued.      Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many     indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during     laparoscopy). This product has the advantage of being well tolerated, easy access and     administration. Three recent studies compared the post-episiotomy analgesic efficacy of local     ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of     these studies showed statistically significant results. However, they focused on the results     at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.   "
15351|NCT03084536|"     In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast     surgery involving the axilla will be administered a multimodal pain regimen including     acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a     Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.   "
15352|NCT03084523|"     Cerebrovascular disease is a major source of neural injury and there is an urgent need for     comprehensive evaluation of these patients. High-resolution MRI (HR-MRI) allows direct     visualization of intracranial vessel wall pathology in the setting of acute ischemic stroke     and intracranial aneurysm (intracranial aneurysm rupture.Vessel wall enhancement on HR-MRI     results from inflammation and has considerable potential as a marker of future stroke risk or     aneurysm rupture. We will use our HR-MRIvwMRI protocol and other techniques of measuring     plaque and aneurysms vulnerability, including laboratory markers of abnormal inflammation and     oxidization, which have been shown to correlate with vulnerable carotid atherosclerosis and     intracranial aneurysms, but have not been studied in symptomatic ICAS or IA.The unmet need is     a study validating HR-MRI reliability and the association of vessel-wall enhancement with     both symptomatic and pro-inflammatory status in patients with cerebrovascular disease.   "
15353|NCT03084510|"     To evaluate the safety and effectiveness of the Lotus™ Valve System for transcatheter aortic     valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic     stenosis who are considered at high risk for surgical valve replacement.   "
15354|NCT03084497|"     The aim of ths study is to know the effects of infant massage in the maturation of the baby     with Down syndrome. Scale Psychomotor Development Early Childhood Brunet-Lézine-Revised will     be used to measure the maturational development of the baby with Down syndrome .     Investigators will analyze two groups of intervention, the experimental group, in which     parents will participate and will apply the knowledge learned in the course of Infant Massage     and control, which does not receive the Infant Massage course during the study. Babies in     both groups will be evaluated twice, at the beginning of the intervention (pretest) and end     it after five weeks (posttest). The study population consists of 32 babies with Down syndrome     between 4 and 8 months old.   "
15390|NCT03084029|"     The main focus of this study is to examine oxytocin effects on behavioral and neural indices     of empathy processing.   "
15391|NCT03084016|"     This study aims to assess the feasibility of capturing data on exhaled breath compounds     during an acute asthma exacerbation. In addition to assessing the feasibility of such a study     the investigators will collect data on exploratory outcomes including the ability of breath     biomarkers to distinguish between controlled and exacerbated states and their ability to     differentiate between triggers of exacerbation.   "
15355|NCT03084484|"     The importance of micronutrients has been extensively reviewed and it was concluded that for     prevention and treatment of periodontitis daily nutrition should include sufficient     antioxidants, vitamin D and calcium.      Up to now there is limited research available investigating the effect of vitamin C     supplementation on the periodontal condition. Supplementation of vitamins and micronutrients     has however raised numerous questions on clinical efficacy. Recently, a significant increase     of medical literature on the effect of nutraceutical dietary aliments on general health has     been noted.      the aim of the present study is twofold. The first objective is to investigate the effect of     twice-daily kiwifruit consumption as sole treatment modality in untreated periodontitis,     followed after two months by initial periodontal therapy supported by continued kiwifruit     consumption. The second objective is to investigate the effect of twice daily kiwifruit     consumption on periodontal and systemic parameters of these periodontitis patients 3 months     after treatment.   "
15356|NCT03084471|"     To evaluate the safety, tolerability, and anti-tumor activity of the combination of     durvalumab + tremelimumab or durvalumab alone in different solid tumors.   "
15357|NCT03084458|"     Medical device technology for use by patients is gaining popularity. Modern cardiac disease     management seeks to integrate multiple device technologies and capabilities to optimize     health outcomes. Fitbit, Inc. manufactures a line of wireless-enabled activity, wearable     trackers that are used in conjunction with a mobile device. The Fitbit trackers use     three-dimensional accelerometers to sense and record movement. This technology represents a     new frontier for patients and their health care providers to understand and track physical     activity in real time. The primary aim of the current project is to assess whether activity     feedback using FitBit technology affects implantable cardioverter defibrillator (ICD) patient     activity level as measured by the ICD accelerometer. The investigators will also examine the     perceived added value of Fitbit technology to an ICD patient user experience.      Approximately 50 participants will be recruited. Participants in the experimental group (n =     25) will use the Fitbit device for 12 weeks. The experimental group will receive fitness     goals (number of steps per day) to increase activity from a baseline value to a minimum of     7000 steps per day by week 9 of the intervention. Both groups will receive weekly texts     messages to encourage activity. Feedback about technology satisfaction, cardiac anxiety,     cardiac self-care, and health care utilization will be elicited from patients at multiple     time points. Additional information will be gained about patient decision-making as     participants may elect to continue Fitbit use beyond the study period; this will allow for     behavioral evidence of the perceived value of adding this technology.   "
15358|NCT03084445|"     Objectives and hypothesis The scale and diversity of chemicals in worldwide use today is     vast. Many of these chemicals are released into the environment where they are found in air,     water, soil, house dust, and in the food supply, resulting in exposure to humans.     Characterizing the extent of exposure and the effects of exposure in vulnerable populations,     such as pregnant women and children, is of the utmost importance as the chemical structure of     many of these compounds resembles hormones such as estrogen, testosterone and thyroid     hormone, affect neurodevelopment and other health effects. Here, we focus on few classes of     compounds: heavy metals, volatile organic compounds (VOCs), brominated flame retardants     (PBDEs) and phthalates. We will characterize the extent of exposure to pregnant women and     their infants in Israel, where biomonitoring studies in the general population are scarce. We     will also examine selected outcomes in pregnant women and their offspring in relation to     these compounds, and to establish a biorepository for further studies.      Specific Aims:        1. To assess Heavy metals, VOCs, PBDEs and phthalates body burdens through measurement of          these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and          neonatal meconium among several representative sub-populations.        2. To examine associations between exposure to heavy metals, VOCs, PBDEs and phthalates and          (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted          for gestational age, ponderal index, head circumference adjusted for gestational age),          and (c) cryptorchidism incidence, (d) maternal and infant thyroid function.        3. To establish a bio repository of these media for future studies and to establish follow          up methods for this cohort to later assess development and growth in the infants,          toddlers and children.      Patients and Methods:      Patients will be recruited from three delivery rooms in Israel: Assaf Harofeh Medical     Center , Lis (Sorasky) Medical Center and Rambam Medical Center, all together with     around 21,000 births annually, representing all sub-populations in Israel. 500     mother-father-infant trios (for a total of 4500) will be recruited.      When arriving to the delivery room, after signing the informed consent, blood and urine will     be withdrawn from the mothers and fathers for Heavy metals, VOCs, PBDEs and phthalates     levels. At the same time thyroid function tests will also be taken from the mothers. After     delivery, cord blood will be taken, as well as meconium from the neonate. Hair, nails and     Breastmilk will also be collected. From the mothers The samples will be analyzed for heavy     metals, VOCs, PBDEs and phthalates. During their stay at the hospital, mothers and fathers     will fill out a standardized questionnaire regarding life style factors, background     information, and exposure opportunities. Detailed information on family history, previous and     present pregnancy, method of delivery, perinatal complications, and pregnancy outcome will be     recorded from the medical files.      Expected contribution to environmental health in Israel:      This will be the first data on sub-populations exposure to Heavy metals, VOCs, PBDEs and     phthalates in Israel. Neonatal meconium levels will provide important information on     magnitude of exposure during the last months of pregnancy, and, thus, will provide insights     into the bioaccumulative nature of these Heavy metals, VOCs, PBDEs and phthalates during     early stages of human development, important data for future risk assessments. Our     comprehensive approach will provide detailed information on the status of each subject. Such     novel knowledge would also lead to the development of preventive and counseling strategies     for men and women with high BFR and phthalates exposure in order to minimize the risks of     adverse outcomes. Knowledge transfer strategies are essential in order that the general     public, health professionals, scientists and policy/law regulators have the appropriate     knowledge on which to base their understandings and recommendations for the future. In this     way, the knowledge that is generated will facilitate the development of prevention strategies     to minimize health risks of Israel population.   "
15360|NCT03084419|"     Early initiation of treatment for Rheumatoid arthritis (RA) can prevent several of the long     term problems associated with the condition. However, many RA patients develop lung     inflammation and scarring, called 'interstitial lung disease' (RA-ILD), contributing to early     death in 1 in 5 people. There is no proven treatment for these patients and some medications     for RA can in fact worsen their lung disease. There is an urgent need therefore to find safe     medications that can not only control RA joint disease, but also prevent progression of     RA-ILD. Abatacept is an approved drug for treating RA and is used widely. It is a newer RA     medication, with a unique mechanism of action, and it has been shown to prevent progression     of joint damage and improve physical function. The investigators aim to assess the safety of     this medication in patients with RA-ILD and improve our understanding of the mechanism of     lung damage in rheumatoid disease.      The investigators will perform a small clinical trial to assess the feasibility of performing     a larger randomised controlled trial. A total of 30 patients with RA-ILD will be treated with     abatacept infusions fortnightly for the first month, then every 4 weeks for a total of 20     weeks. In order to be eligible for the study, a patient must be able to provide written     informed consent, be aged ≥18 years, have moderate to severe RA joint disease activity (DAS28     ≥3.2) and have interstitial lung disease that has not responded to or progressed over 6     months despite conventional immunosuppression. Change in lung function (forced vital     capacity) at 24 weeks will be evaluated. To assess the mechanisms that may be involved with     the development of ILD, the investigators will assess the effects of abatacept on biomarkers     obtained from the blood and the lung (bronchoalveolar lavage), including markers of infection     (the lung microbiome).   "
15361|NCT03084406|"     The pilot test of Centervention-ATOD, a customizable suite of online tools specifically     designed to support quality implementation and sustainability of any ATOD-EBP within     real-world service settings, will evaluate whether the product awards additive benefits in     provider implementation proficiency and efficacy, quality of implementation delivery, and EBP     (i.e., Free Talk or CHOICE) outcomes compared to traditional implementation methods.     Additionally, a cost-effectiveness study will be conducted to assess whether the     implementation support strategy (i.e., Centervention-ATOD) is more cost-effective than     traditional implementation methods.   "
15362|NCT03084393|"     To study on the Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism     and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether     the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin     B12 could be used as predictor(s) of POCD and to provide reference for POCD prevention, early     detection and timely diagnosis and treatment.   "
15363|NCT03084380|"     The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3     scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating     patients with GPC3-positive advanced hepatocellular carcinoma (HCC).   "
15364|NCT03084367|"     This is a pilot study designed to assess the relationship between iFR pullback and the     distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography     (QCA) post angiographically successful PCI.   "
15388|NCT03084055|"     Physical activity has many potential mood enhancing benefits, and may be as effective as     anti-depressants and psychological therapies for treating depression and low mood. However,     getting people with depression to become more active is challenging. Behavioural Activation     (BA) is an evidenced based psychotherapeutic treatment that focuses on increasing exposure to     positive environmental stimuli which could provide an effective delivery mechanism for     increasing physical activity for people who are more sedentary than the general population.     The purpose of this study is to examine the feasibility of delivering a theory informed     online intervention combining physical activity and BA (eMotion) to people with depression,     and to examine its effects on depressive symptoms and physical activity.   "
15392|NCT03084003|"     The purpose of the study is to examine the effects of almond snacking on metabolic,     cardiovascular and microbiome profiles in college freshmen.   "
15365|NCT03084354|"     Background.      Although a healthy urinary system is a vital aspect in every woman's life, bladder management     is an aspect of maternity care, which is, or perceived as, being poorly managed by health     care professionals. Furthermore, although the relationship between childbirth and bladder     dysfunction is an incontestable fact very well documented in the medical literature, women's     experiences of bladder care have not been recognized by the evidence, and therefore, no     research has been developed to address this topic. This fact implies a limited level of     awareness and degree of implication from women in this matter.      Research question.      What are women's experiences, perceptions and knowledge of bladder care during the     antepartum, intrapartum and postpartum period?      Aim.      To explore women's experiences of bladder care during the antepartum, intrapartum and     postpartum period.      Design.      Exploratory, descriptive research study.      Population.      Women who have given birth to a singleton, live, term baby between two weeks and six months     prior the study, and who meet the inclusion and exclusion criteria.      Methods.      In-depth semi-structured interviews.      Sample.      A purposive sample of eight to sixteen women, with a heterogeneous representation of the     different modes of birth, will be sought.      Recruitment.      Postnatal midwives will act as gatekeepers identifying potential participants and providing     information packs. Other recruitment resources will include posters and a study website,     which will be advertised at local maternity groups.      Data collection.      Semi-structure interviews to gain a deep understanding of women's experiences of maternity     bladder care. Interviews will last between thirty minutes to a couple of hours and they will     be digitally recorded and transcribed verbatim.      Data Analysis.      Framework analysis assisted by memoing technique.      Ethical considerations.      Ethical approval from the Sponsor and the Health Research Authority will be sought.   "
15366|NCT03084341|"     The main objective of this study is to compare the effect and the duration of the     Neuromuscular Electrical Elongation (NMEE ) technique versus the PNF technique and versus a     control group, on the extensibility of the hamstrings muscles.      Hypothesis:      NMEE of shortened hamstrings muscles in healthy subjects, compared with PNF and control group     produces a significant increase in hamstrings extensibility.   "
15367|NCT03084328|"     Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our     observations in the Metabolic Liver Clinic and that reported by others. We also observed that     patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have     shown that replacing Vitamin D in patients with cirrhosis is effective and even patients with     Vitamin D replete status have lowering of Vitamin D over time if not supplemented.      One of the measures of liver injury in NAFLD is the plasma concentration of ALT and we will     use this to follow patients as is currently done as standard of care. All patients in the     Metabolic Liver Clinic are being routinely screened for Vitamin D deficiency as standard of     care and treatment is being started with oral supplementation, but there are not standardized     protocols to determine success of therapy. We hypothesize that patients with NAFLD with low     Vitamin D levels will respond appropriately to Vitamin D supplementation for 6 months.   "
15368|NCT03084315|"     To determine changes in biomarkers associated with the use of electronic cigarettes among     African American menthol and nonmenthol smokers.   "
15408|NCT03083795|"     This study will determine the feasibility and effectiveness of a monthly social support group     along with a weekly peer-to-peer meeting in improving perceived level of social support,     diabetes distress, and A1c profiles in patients with Type II diabetes mellitus, compared with     standard care offered at British Columbia Diabetes (BC Diabetes).   "
15369|NCT03084302|"     The investigators will study sedentary behavior (SED) across pregnancy in young women. We     hypothesize that SED will increase across pregnancy and that higher SED will be related to     worse cardiovascular health, specifically elevated blood pressure (BP) and excessive     gestational weight gain (GWG). Pregnancy is a biologically relevant period during which CVD     risk factors may develop or worsen, contributing to future CVD. Pregnant women also spend     most of their day sedentary, which is defined as too much sitting as distinct from too little     exercise. SED has emerged as a risk factor, independent from moderate-to-vigorous physical     activity (e.g., exercise), for elevated BP, obesity, diabetes, CVD, and mortality in general     populations, but there are no recommendations for SED during pregnancy and few studies     evaluate SED across pregnancy. These few studies are limited by small sample size, lack of     repeated measures across trimesters, suboptimal SED assessment methodology, and a failure to     link with clinical outcomes (e.g., BP, GWG). The investigators will address these gaps in a     prospective study that will measure SED in 130 pregnant women across three trimesters using     state-of-the-art objective activity monitors capable of measuring min-by-min activity by both     intensity and posture. We will also measure BP and GWG during each trimester and, further,     will link to and abstract all prenatal clinic weights and BPs, glucose screening results,     gestational diabetes, preeclampsia, and adverse birth outcomes. Lastly, with the long-term     goal of identifying women at high risk of SED during pregnancy and designing effective     interventions, the investigators will efficiently evaluate correlates and determinants of SED     which have never been studied during pregnancy.   "
15370|NCT03084289|"     The purpose of this study is to assess the safety and immunogenicity of novel routes of     administration of the candidate malaria vaccine ChAd63 encoding ME-TRAP.      15 Healthy adult volunteers will be recruited in Oxford.      All vaccinations will be administered intravenously or subcutaneously. Each volunteer will     receive a single vaccination of ChAd63-ME-TRAP at different doses depending on the group.   "
15371|NCT03084276|"     Aim: to determine to what extent meal composition influences postprandial sensations     independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a     high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic     characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on     a cross-over design. The responses to the meals will be tested on 2 different days.     Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day     before, to consume a standard breakfast at home after overnight fast, and to report to the     laboratory, where the test meal will be administered 3 h after breakfast. Studies will be     conducted in a quiet, isolated room with participants sitting on a chair. Perception will be     measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals     up to 60 min after the probe meal.   "
15372|NCT03084263|"     The objective of this study is to compare the functional outcomes of patients with ankle     fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus     Open Reduction Internal Fixation (ORIF).   "
15373|NCT03084250|"     The CHB subjects who are cirrhosis, will be randomized to two groups.      The subjects who go into group A will be treated by nucleotide analogue (NA) combination with     peginterferon alfa-2a,180μg/week for 48 weeks.      The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48     weeks.   "
15374|NCT03084237|"     This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and     to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin®     in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent     or previously untreated metastatic breast cancer.   "
15393|NCT03083990|"     To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .   "
15376|NCT03084211|"     Introduction: Current guidelines for treating patients with mild traumatic brain injury     (MTBI) recommend a period of cognitive rest and gradual return to usual activities with     avoidance of any activity that exacerbates symptoms. However, recent studies have reported     prolonged rest beyond 48 hours might hinder MTBI recovery, and there is limited evidence to     suggest following guidelines has a positive impact on prognosis. Given the paucity of     effective management strategies to prevent post-concussion syndrome (PCS) and emerging     evidence of the benefits of exercise in MTBI patients, there is an urgent need for more     research on the effectiveness of an early exercise intervention in the acute MTBI patient     population as prevention of PCS.      Research Question: Among adult (18-64 years) patients presenting to the ED with a discharge     diagnosis of acute MTBI (defined by the Zurich consensus statement), does prescribing light     exercise (ie: 30 min daily walking) reduce the proportion of patients with PCS at 30 days,     compared to standard discharge instructions?      Methods: This will be a randomized controlled trial of adult (18-64 years) patients     discharged from an academic ED diagnosed with MTBI occurring within 48 hours of the index ED     visit. The intervention group will receive discharge instructions prescribing 30 minutes of     light exercise (ie: walking) and the control group will be instructed to gradually return to     activities. Discharge instructions will be read by the attending physician or ED nurse.     Patients will be provided a printed copy of the discharge instructions. Depending on their     preferences, patients will be contacted by email or by telephone to complete the Rivermead     Post-Concussion Symptoms Questionnaire (RPQ), a validated, 16 item questionnaire.      The primary outcome of this study will be the proportion of patients with PCS at 30 days,     defined as an increase from baseline of ≥ 3 symptoms on the validated RPQ at 1 month.     Secondary outcomes will include change in RPQ from baseline to 72 hours, 7 days, 14 days, 30     days post initial ED visit, number of missed days of school or work and repeat visits to a     healthcare provider. To assess compliance with ED discharge instructions, patients will be     asked to complete a daily activity journal and will be given fitness tracking devices.   "
15377|NCT03084198|"     This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system     in treating acute liver failure.   "
15378|NCT03084185|"     This is a single-center and prospective study to identify specific biomarker in order to     predict development of decompensation in cirrhotic patients.      The duration of the study is 36 months and it provides a cohort of 200 patients.   "
15379|NCT03084172|"     Based on clinical evidence based medicine and organizational management model, investigators     redesign the prevention and treatment of chronic kidney disease of public health system in     Shanghai China. The investigators hope to find early chronic kidney disease, prevention and     clinical intervention of orderly combination. The advantages of this system were confirmed by     comparing the prevalence rate, awareness rate and treatment rate before and after the     completion of the system.   "
15409|NCT03083782|"     This study aims to evaluate the pharmacokinetics (PK) of apixaban when co-administered with     cyclosporine and tacrolimus in healthy volunteers. The study participants will receive     apixaban alone, cyclosporine followed by apixaban and tacrolimus followed by apixaban.   "
15410|NCT03083769|"     The purpose of this study is to determine whether functional genetic variants can affect     tacrolimus dose corrected trough levels and associate with the side effects in Chinese renal     transplantation and liver transplantation.   "
15380|NCT03084159|"     This study will use an adapted education worksheet to support patient-centered chronic kidney     disease (CKD) communication, shared decision making, and patient engagement and will test its     impact on intermediate patient modifiable characteristics in a primary care practice with     patients who have pre-dialysis CKD.      The study team will enroll up to 50 patients with chronic kidney disease (CKD) from a primary     care clinic to start. Patients will receive the intervention, which consists of the     physicians using the education worksheet during appointments with patients, and patients and     providers will complete surveys about its use and to measure impact on knowledge and other     areas related to patient outcomes.      Once initial user testing is complete, the study team plans to submit an amendment to expand     on this trial and incorporate comparison sites. This will be submitted and receive IRB     approval prior to participant involvement.      The study hypothesis is that patients who receive the intervention will have greater     knowledge about their CKD diagnosis, higher satisfaction with provider communication, and     higher scores related to managing CKD to keep themselves healthy compared to control     populations.   "
15381|NCT03084146|"     Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no     cure for psoriasis and treatment is directed at controlling patients' symptoms. The purpose     of this study is to determine whether psoriasis patients are more likely to have food     sensitivities than those patients without psoriasis. We will also determine if eliminating     certain foods from the diet results in a change in psoriasis symptoms.   "
15382|NCT03084133|"     The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of     patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family     history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the     recommended screening test. In France, the rate of screening colonoscopy in this population     at high risk of CRC is insufficient, which limits the effectiveness of this targeted     screening.      The main reason for this low participation rate is that most patients undergoing RCC or     advanced adenoma are unaware of the family implications of their diagnosis and therefore     reluctant to disseminate this information to their patients Related matters. The need for a     better perception of the personal risk of CRC in first-degree relatives of patients with CRC     or advanced adenoma, with the expected coronary adherence to increasing screening, requires a     good understanding of risk through Clear, adapted and comprehensible information that can be     relayed personally by the case-index.      The objective of this project is to develop a personalized prevention and screening program     for the JRC in order to meet the needs of the relatives of the sick. The means of     intervention that will be implemented respond to the need to better take into account the     level of CRC risk in a family-based CRC screening and prevention approach adapted to a     high-risk CRC group characterized by Family history at the first stage of CRC or advanced     adenoma and, consequently, to improve the information of the subjects concerned by screening     and prevention of CRC.      The aim of the case-index education is to induce its intervention with its relatives to     promote CCR screening. The use of the index case, as a means of providing information to     relatives, implies an educational and psychological approach, based on evidence, but adapted     and personalized.   "
15383|NCT03084120|"     This study evaluates effect of the Maternal Obesity and/or the By-pass on the Growth and the     Nutritional Balance of the Child.The data stemming from mothers presenting obesity or an     overweight during their pregnancy and the data stemming from mothers having had a by-pass     will be compared with the data stemming from mothers with a normal BMI (Body Mass Index),     considered as a reference group. It's the same for the data stemming from newborn children.     The newborn children stemming from groups of obese mothers or in overweight will be compared     with the data stemming from mothers belonging to the reference group.   "
15384|NCT03084107|"     The aim of this project is to create ten smart devices that involve combining an interactive     art environment with IC technology, arts and health administration. Investigators invited the     elderly residents of Chang Gung Health and Culture Village to participate in the application     of these devices, and participants were also requested to complete a technology acceptance     model (TAM) questionnaire for these smart devices.   "
15385|NCT03084094|"     One of the big challenges faced by researchers who act in rehabilitation science is the     capacity to dispose integrative approaches for its utilization in clinical practice. The     border profile of a physiotherapy researcher is to be in front of applied research     amplification in experimental integrative approaches, involving the study of behavioral and     physiological variables.      The rehabilitation process transcends the systems physiology and encompasses the cognitive     behavioral feature of being adapted to the environment that surround us. It is now known by     the scientific rehabilitation community the necessity for evidence based therapies and even     more, therapeutic innovation. In both conditions, of health and illness, various options to     use integrative approaches are today available in physiotherapy, including behavioral and     physiological profiles of the individuals during physical activities, response to stress and     in the field of chronic pain.      It is in the clinical routine of numerous rehabilitation centers the treatment of diseases     that causes pain, being the leading figure in a physiotherapist work process. The innovative     study of resources that can alter the pain state of this patients becomes primordial for     routine clinical use, low cost and easy to apply. The therapeutic treatment for pain offered     by a physiotherapist need new investigative options based in evidences from the association     between the neuronal, behavioral and physiological responses where the brain is the central     organ of this regulation. In this context, become increasingly more necessary the     construction of investigative approaches in the purpose of reaching the clinical practice, in     a reduced time lapse, once the great volume of information produced globally does not impact     in short or medium term in new therapeutic recommendations.      Among the various chronic painful entities, it is presented the fibromyalgia (FM), painful     diabetic polyneuropathy and primary dysmenorrhea because of its painful pathogenic complexity     and its limited therapeutic against pain in rehabilitation process. The 3 painful entities     presents the central nervous system as main participant of neurogenesis and maintenance of     the painful state.      It is primordial importance that rehabilitation science improve methods of non invasive brain     neuromodulation that allows, through excitation or inhibition of specific cortical areas in     order to produce pain inhibition, providing a simple and low cost treatment to clinical     routine. Technological advances and non invasive techniques to modulate brain function has     been developed, among which transcranial direct current stimulation (tDCS) stands out.     Basically, electrodes are placed in targeted brain regions that you want to stimulate or     inhibit. Posteriorly, is applied a continuous electric current (0,4 - 2 mA) for a 3-20     minutes period, in order to modify cortical excitability. The stimulus of the anodic current     increases cortical excitability whereas the stimulus of the cathodic current has an     inhibitory effect.      Few are the research groups that address the issue of fibromyalgia, painful diabetic     polyneuropathy and primary dysmenorrhea and the application of tDCS as research focus, being     a border area for rehabilitation science and great potential in clinical use. Preliminary     studies associates the use of tDCS with the decrease of painful state, however an approach of     physical function and behavioral results needs greater investigation.      The purpose of the presented project is to present the tDCS as a new modality in physical     rehabilitation for the patient with chronic pain of the 3 entities mentioned above. The study     proposal is to present behavioral, social and physical results of tDCS application in this     patients, suggesting a better quality of life and functionality of the individual.   "
15386|NCT03084081|"     The purpose of this academic-industrial partnership will compare the CryoPen® and     thermoablator to traditional CO2-based cryotherapy for the treatment of cervical precancer in     low and middle income countries (LMICs) and investigate whether the cure rates of cervical     intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are     non-inferior compared to that of conventional cryotherapy. The results of this study will     affect other research areas by serving as a springboard to exploring treatment alternatives     that are amenable to low-resource settings and thus will reach the most vulnerable     populations.   "
15387|NCT03084068|"     To determine the effectiveness of human dehydrated umbilical cord allograft in standard open     rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12     months post-op.   "
15394|NCT03083977|"     Chronic pain is a common ailment in aging populations and often co-occurs with altered     regulation of the autonomic nervous system. Nociceptive pathways (i.e., those that transmit     pain signals) are integrated with autonomic circuits throughout the body and therapies that     are successful in reducing pain concurrently alter autonomic functions, even when they are     not directly designed to do so. It is possible that interventions that target the autonomic     circuits that regulate pain responses may help reduce pain in chronic pain sufferers. The     proposed study will examine whether an intervention that targets the autonomic nervous system     via filtered music can reduce pain, a hypothesis derived from the Polyvagal Theory.      The Polyvagal Theory describes how function and structure of the vertebrate autonomic nervous     system changed during evolution. The theory is named for the vagus, a major cranial nerve     that regulates bodily state. An evolutionary old branch of this nerve innervates structures     below the diaphragm and its dysfunction is linked to lower body organ and tissue pain.     Regulation of the vagus nerve is linked with specific auditory cues based on our evolutionary     heritage and the physics of the middle ear. This study is designed to test whether processed     music designed to stimulate vagal function can decrease chronic pain. The Listening Project     Protocol, the processed music used in this intervention, has previously been shown to     effectively stimulate the function of the vagus nerve (see stimulus description below).      Specific Aims:      Aim I: To examine whether The Listening Project Protocol, a non-invasive audio intervention,     can be effective for reducing chronic pain in a sample of older adults.      Hypothesis: Five 1-hour sessions of the Listening Project Protocol will reduce pain      Aim II: To examine whether increased regulation via the autonomic nervous system accounts for     the decrease in pain if the intervention is successful.      Hypothesis: Pain reduction will coincide with improved autonomic function by the myelinated     vagus nerve (measured by respiratory sinus arrhythmia, see below) as well as decrease in the     reactivity of autonomic functions in everyday experiences (measured by the Body Perception     Questionnaire, see below)   "
15395|NCT03083964|"     The purpose of this study is to A) capture obesogenic cues that occur in daily life, and B)     to deliver cue alerts. Investigators hypothesized that A) black women experience more cues,     B) racial disparities in obesity are reduced in models that adjust for cues, and C) the     priming arm will achieve a weight loss of 2kg or more. Investigators will explore whether     racial disparities in weight loss differ between the groups receiving usual care or those     receiving cues.   "
15396|NCT03083951|"     A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior     mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from     the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in     patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.   "
15439|NCT03083392|"     This study is intended to evaluate the efficiency of utilizing dynamic implant valve     approach (DIVA) system in treating chronic maxillary sinusitis.   "
15397|NCT03083938|"     Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at     periampullary area, the morbidity and mortality rate with intra-abdominal collection, post     pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately     50-60%. The causes of these complications usually come from post-operative pancreatic     fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic     fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of     intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft     tissue.      Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and     requires no extra treatment expenses of the patient. It has been reported this technique has     been applied in the non-randomized controlled trials and their data have significantly shown     that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to     conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal     anastomosis and non-omental roll-up groups.   "
15398|NCT03083925|"     To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12     months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4     months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE,     readmission, liver injury, cardiac function, response to TIPS and the passive expansion of     the stents in real life.   "
15399|NCT03083912|"     The hypothesis of this study is that the administration of a high-calorie high-protein oral     nutritional supplement twice a day for three months to elderly malnourished in residents in     Spain is associated with improved nutritional status, with an increase in body weight of     between 5 and 8%, and an improvement in functional status, with low incidence of     complication.   "
15400|NCT03083899|"     People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit     procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an     appointment with a nurse or doctor within defined time intervals via telephone, e-mail or     apps. Patient-reported outcomes, clinical variables (HbA1c, blood pressure etc.) and use of     human resources (doctors, diabetes-nurses and diet physicians) are monitored.   "
15401|NCT03083886|"     Low back and neck pain are among the leading causes of medical visits, lost productivity and     disability. There is an urgent need to identify effective and efficient ways of helping     subjects with acute spine pain while guiding practitioners towards high-value care. This     trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized     clinical trial comparing healthcare spending and clinical outcomes for subjects with spine     pain of less than six weeks duration, in whom there are no red flag signs or symptoms.     Subjects will be randomized to one of three treatment strategies: (1) usual primary care     provider-led care; (2) usual PCP-led care with spine pain treatment directed by the Identify,     Coordinate, and Enhanced decision making (ICE) care model, and (3) usual PCP-led care with     spine pain treatment directed by the Individualized Postural Therapy (IPT) care model. Our     outcomes of interest will be spine-related healthcare utilization at one year as well as pain     and functionality of the study participants.   "
15402|NCT03083873|"     Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive     cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145)     followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the     treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head     and neck   "
15403|NCT03083860|"     Evaluation of migraine management mobile app combined with electrophysiological measurements     for identification of migraine attack risk and beneficial preventive actions.   "
15417|NCT03083678|"     In this phase 2, single arm trial patients with locally advanced or metastatic,     pathologically proven, EGFR expressing chordoma will be treated with afatinib. Two cohorts of     patients will be included: 20 first line patients and 20 second or further line patients. The     treatment will be given in 4 week cycles until disease progression. Median PFS according to     RECIST 1.1 will be evaluated. The objective is to increase the median PFS ≥ 12 months in     first-line treatment cohort and ≥ 9 months in later-line treatment cohort. Additional     exploratory research will be performed, consisting of a pharmacokinetic study and     translational studies on EGFR pathway activation and signalling on blood and tumor samples.   "
24420|NCT02966015|"     The aim of the study is to investigate the navigation of a newly developed catheter.   "
15404|NCT03083847|"     Background:      People get malaria from bites from infected mosquitos. Researchers are studying a vaccine     strategy. They will give people malaria parasites by injecting them with live infectious     malaria parasites with antimalarial medications and then see if this strategy prevents     malaria infection while off antimalarial medications.      Objective:      To see if combining a high dose of live, infectious malaria parasites (known as Sanaria PfSPZ     Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] OR     chloroquine [CQ]) is safe and can provide people protection against malaria.      Eligibility:      Healthy adults ages 18-50 who:        -  are not pregnant or breastfeeding or planning on becoming pregnant while in the study        -  are not infected with HIV, Hepatitis B or Hepatitis C        -  have reliable early morning access to the NIH Clinical Center        -  are able to come to the outpatient clinic frequently, sometimes daily        -  have not been diagnosed with malaria within the past 10 years      Design:        -  Participants will be screened with medical history and physical exam. They will have          heart, blood, and urine tests.        -  Participants will have blood drawn for tests at most visits.        -  Participants will keep track of their temperature and symptoms during some sections of          the study.        -  Participants will join one part of the study.      Part 1 is one month:        -  Participants will get the parasites by an injection into a vein on day 1 and receive          antimalarial medications.        -  They will have daily visits on days 7-14        -  They will take another antimalarial at visits on days 15-17.        -  The final visit will be on day 29.      Part 2 is seven months:        -  For the first 3 months, participants will get the parasite injection into a vein for 3          injections in total. Each injection will occur once per month while taking an          antimalarial drug.        -  They will have daily visits on days 7-14 after the first injection, and on days 7-11          after the second and third injection.        -  They will have a final (fourth) injection around month 6 without any antimalarial          medication.        -  After this fourth injection, participants may have up to 21 daily visits from day 7          after injection until end of study.      Part 3 is one month:        -  Participants will get the parasites by injection into a vein on day 1 without          antimalarial medications.        -  They will have visits almost every day starting day 7 from injection.        -  They will take an antimalarial medication when they are diagnosed with malaria        -  They will return for final end of study visit on days 27-29.   "
15405|NCT03083834|"     In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since     mitotane increases cortisol binding globulin levels (CBG), artificially raising total     cortisol. Salivary free cortisol (SC) is not affected by CBG alterations, and reflects the     free serum cortisol.      In the current study, investigators will assess serum and SC responses during low-dose     cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on     steroid replacement therapy and in patients who suffer from hypoadrenlism caused from other     etiology. Investigators will compare results between groups and try to demonstrate the     superiority of SC in assessing adrenal function in mitotane treated patients.   "
15406|NCT03083821|"     A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.   "
15411|NCT03083756|"     This study validate the usefulness of SIMPLICITY score to characterize the immune status of     the kidney transplant receiver at two points along its course (the one and six months after     transplantation), by determination in peripheral blood of various parameters related to     cellular immunity (count subpopulations of CD3+ (cluster of differentiation 3), CD4+ (cluster     of differentiation 4) and CD8+( cluster of differentiation 8)), humoral immunity     (immunoglobulins count) and innate (complement).   "
15412|NCT03083743|"     The trial is to evaluate the efficacy and safety of recombinant human Apo-2 ligand in     treating patients with advanced retreated non-small cell lung cancer   "
15413|NCT03083730|"     Atopic dermatitis (eczema) is a chronic inflammatory disease that causes significant     morbidity and is now known to be associated with cardiovascular disease. Research such as     this will add to the understanding of the skin as a contributor to systemic inflammation, and     it is important to clarify whether skin-only treatment can alleviate systemic inflammation,     and potentially influence cardiovascular risk factors.   "
15414|NCT03083717|"     Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart     Failure by Respiratory Samples.      Breath testing, which links specific volatile molecular biomarkers in exhaled breath to     medical conditions, is becoming increasingly popular as a non-invasive and potentially     inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from     exhaled breath, thus producing a distinct fingerprint for each mixture of analytes.      Several studies have been published, stating the advantages of these sensors, leading to     promising outcomes in several fields.      The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10     min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free     of any side effects.   "
15415|NCT03083704|"     This is a randomized, double-blind, study in healthy volunteers dosed to steady state with     fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet     manufactured by the Generation 1 and Generation 2 processes, (2) evaluate the degree to which     the Generation 2 andexanet reverses fXa-inhibitor-induced anticoagulation in comparison to     placebo, and (3) evaluate safety of Generation 2 andexanet.   "
15416|NCT03083691|"     BIOLUMA is a multicentric non-randomised phase II trial in patients with non-squamous     non-small cell lung cancer (NSCLC) (Cohort 1) and patients with small-cell lung cancer (SCLC)     (Cohort 2) after failure of platinum-based first-line therapy. NSCLC patients are treated     with nivolumab until disease progression and subsequently receive a combination therapy of     nivolumab and ipilimumab. SCLC patients receive four cycles of nivolumab in combination with     ipilimumab and subsequent nivolumab monotherapy. Primary endpoint for both cohorts is overall     response rate of combination therapy.      Within the diagnostic part tumor biopsies will be analysed. Tumor tissue will be obtained     before initiation of therapy and after progression on nivolumab monotherapy before addition     of ipilimumab in Cohort 1 and after completion of the four nivolumab/ipilimumab combination     cycles before continuation of nivolumab monotherapy in Cohort 2, respectively. Flow cytometry     of blood samples and microbiome analysis of deep rectal swaps are performed prior to therapy     as well as during course of treatment.   "
15501|NCT03082573|"     This study will examine the clinical response, cytokine expression and joint imaging after     addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for     treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism     of action than steroids and other DMARDs.   "
15418|NCT03083665|"     The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to     placebo (PBO) as adjunctive treatment in Asian subjects (>=16 to 80 years of age) with     partial seizures with or without secondary generalization despite current treatment with 1 or     2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in     subjects >= 16 years to 80 years of age.   "
15419|NCT03083652|"     Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU)     stay may improve exercise capacity and prevent muscular weakness in critically ill patients     with respiratory disease. Main objective: To evaluate, in respiratory critically ill     patients, the effects of a conventional physiotherapy program with or without additional NMES     applied only during the ICU stay on exercise capacity. Design: Randomized, controlled,     double-blind clinical trial on patients (>18yo) with diagnosis on admission of acute or acute     on chronic respiratory disease, on mechanical ventilation (MV) > 72h and expected MV > 24h.     Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on     quadriceps femoris and gluteus maximus. Patients in the control group will follow the same     protocol but the device will not be activated. Measures: Demographic data, body composition     through bioelectrical impedance analysis (BIA), and functional capacity before admission     through Barthel scale will be registered upon inclusion. Exercise capacity through test     sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry,     body composition through BIA, and functional capacity through Barthel scale will be obtained     at ICU and hospital discharge.   "
15420|NCT03083639|"     The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram     (mg) tablets and capsules.   "
15421|NCT03083626|"     This current study is intended to be completed under the umbrella of the current GHUCCTS IRB-     approved study Opioid-Induced Hyperalgesia In Prescription Opioid Abusers: Effects of     Pregabalin (Lyrica study) (PRO00000669). In this proposed study, 10 healthy male, 10 healthy     female participants and 5 male, 5 female OIH participants (from the parent Lyrica study), who     are prescription opioid abusers with chronic pain currently taking Suboxone, will be asked to     take the cold pressor test at 1, 5, and 9 degrees Celsius and to report the time at which     pain has completely gone away following each test. The purpose of this study is to examine     how the water temperature of the cold pressure test might affect the participants' response     (i.e., the participants pain threshold and pain tolerance) and to see if there is a     difference in how each participation group is affected.   "
15422|NCT03083613|"     This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and     safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with     unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary     endpoint of this study is objective response rate.The secondary endpoint of this study is     safety,progression-free survival and overall survival.   "
15423|NCT03083600|"     To evaluate the effectiveness of three different daily doses of plant protein hydrolysates     versus placebo, when consumed over a 12-week period, at reducing and maintaining glycated     haemoglobin (HbA1c) levels in a pre-diabetic population (otherwise healthy subjects with     impaired glucose metabolism).      To evaluate the effectiveness of three different daily doses of pea or rice protein     hydrolysates versus placebo, when consumed over a 12-week period on: post-prandial     glucose/insulin levels (oral glucose tolerance test, fructosamine levels, fasting plasma     glucose levels, vital signs, physical examinations, weight and blood pressure.   "
15424|NCT03083587|"     There is a growing health burden in Sweden and Europe arising from the interrelated sequelae     of metabolic disorders comprising impaired glucose tolerance (IGT), obesity and T2DM. Obesity     and inactivity are the main drivers of IGT and T2DM and are responsible for up to 8% of     health costs and 13% of deaths in Europe, with the risk of co-morbidities rising in parallel     with increasing body weight. IGT and T2DM are the paradigm of inactivity-related disorders:     the majority of people who have IGT or T2DM are overweight and inactive, with up to 80% being     obese. A recent meta-analysis of 42 studies concluded that sedentary time was independently     associated with a greater risk of T2D, all-cause mortality, cardiovascular disease incidence     and mortality, and cancer incidence and mortality (breast, colon, colorectal, endometrial and     epithelial ovarian cancers) (Ann Intern Med. 2015;162:123-32). A recent systematic review of     trials published up to April 2014 identified 16 separate studies and concluded that there is     considerable evidence of the positive effects of breaking up prolonged sitting time with     light-intensity ambulatory physical activity and standing on postprandial metabolic     parameters, including glucose, insulin and triglyceride levels (Med Sci Sports Exerc.     2015:47:2053-61). However, to date, all of the published experimental trials describing the     beneficial effects of breaking up sitting time on metabolic risk markers have been restricted     to acute exposure periods (1-5 days). We will perform a RCT intervention study, which     examines the efficacy (clinically relevant responses) and practical implementation of     low-impact training in sedentary obese individuals during the day.   "
15425|NCT03083574|"     The present project is a prospective, multicenter, non-randomized, phase II trial which aims     to evaluate the clinical impact and the safety of extracorporeal photopheresis (ECP) using     the Theraflex system in patients with refractory chronic graft versus host disease (cGVHD)     after any type of hematopoietic stem cell transplantation or after donor lymphocyte infusion.   "
15426|NCT03083561|"     The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in     healthy Japanese and Caucasian participants. The study will also investigate how the body     processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4     weeks for each participant. Screening may occur within 28 days prior to first dose of study     drug.   "
15447|NCT03083288|"     Up to 30 evaluable participants with known or suspected breast cancer (BIRADS 5 by imaging)     will undergo FTT PET/CT imaging before primary surgery or neoadjuvant therapy. Patients     undergoing neoadjuvant therapy may choose to have a second FTT PET/CT scan after the start of     therapy (1 days to 3 weeks). FTT PET/CT uptake will be correlated with pathology measures and     treatment response, in subjects undergoing neoadjuvant therapy   "
15568|NCT03081702|"     This is a phase I/II study to find the highest dose of hydroxychloroquine that can be given     safely with itraconazole in patients with advanced platinum-resistant epithelial ovarian     cancer. The study will also determine the safety, tolerability, and initially determine     whether the combination is useful in the treatment of patients with advanced     platinum-resistant epithelial ovarian cancer.   "
15427|NCT03083548|"     The Nor-Hand study is a hospital-based observational study including 300 patients with     evidence of hand OA by ultrasound and/or clinical examination. The baseline examination     (2016-17) consists of functional tests and joint assessment of the hands, medical assessment,     pain sensitization tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet),     computer tomography (CT) and Magnetic Resonance Imaging (MRI) of the dominant hand,     conventional radiographs of the hands and feet, fluorescence optical imaging of the hands,     collection of blood and urine samples as well as self-reported demographic factors and     OA-related questionnaires. Two follow-up examinations are planned after 4 (2020-21) and 8     years (2024-25), respectively. Cross-sectional analyses will be used to investigate     agreements and associations between different relevant measures at the baseline examination,     whereas the longitudinal data will be used for evaluation of predictors for clinical     outcomes.   "
15428|NCT03083535|"     Periodontal disease is a multifactorial disease caused by mainly bacterial, genetic,     immunologically, and environmental factors. Chronic periodontitis, one of the widely     prevalent forms of periodontal disease, is characterized by loss of attachment apparatus of     the tooth; it can lead to tooth loss. Many non surgical and surgical approaches have been     adapted time and again to prevent, intercept, and to treat the various forms of chronic     periodontitis. But, these treatment modalities are not approachable by all individuals,     because of the various factors such as: low socioeconomic status, illiteracy, high cost of     the treatment, no availability of easy and uncomplicated treatment nearby etc. Considering     these factors, we are still in need of preventive, practical, and affordable treatment     options specially for the population of underdeveloped and developing countries.   "
15429|NCT03083522|"     The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on     Korean Patients With Cold Hypersensitivity in the Hands   "
15430|NCT03083509|"     The aim of this study to increase understanding of physiological and functional perturbations     following a continuum of exercise stressors.   "
15431|NCT03083496|"     This study aims to evaluate the longevity and efficacy of two products potassium     oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial     (split-mouth) . The desensitization approach (single agent) and the long-term effectiveness     (baseline, 1 week, 2 weeks, 3 weeks). Data will be collected, tabulated and submitted to     statistical analysis.   "
15440|NCT03083379|"     The primary purpose of this study is to determine if there is a significant difference in     regional distribution of ventilation when comparing eupneic tidal ventilation with Incentive     Spirometry (I.S.) and EzPAP® lung expansion therapy in healthy adult human subjects.     Electrical impedance tomography (EIT) will be used to measure regional distribution of     ventilation during resting tidal ventilation and during lung expansion therapy.   "
15432|NCT03083483|"     The purpose of this study is to test the influences of transcranial direct current     stimulation (tDCS) and gaze training (GT) on the acquisition of laparoscopic surgical skills.     For this purpose, the investigator will compare variants of tDCS and GT in experiments 1 and     2, respectively, and then compare the optimal variants from each of these in experiment 3 in     a crossed design with a follow up test of retention. These questions will be evaluated using     the validated Fundamentals of Laparoscopic Surgery (FLS) modules 1 and 5, with the overall     goal of developing a surgical training curriculum that achieves expert level skill in an     expedited timeframe. This research provides a novel approach to general surgery training that     has the potential to reduce the amount of time and repetitions required to achieve expert     laparoscopic skills.   "
15433|NCT03083470|"     A Phase 2, randomized, double-blind, dose rising study to determine the safety, tolerability,     and preliminary efficacy of four concentrations of SOR007 (Uncoated Nanoparticulate     Paclitaxel) Ointment (SOR007) compared to SOR007 ointment vehicle applied to actinic     keratosis (AK) lesions on the face twice daily for up to 28 days.   "
15434|NCT03083457|"     Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and     to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.      A recent large randomized controlled trial failed to detect a significant difference between     two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled     recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients     undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different     positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be     established.      Design: prospective, cross-over, physiological trial.      PURPOSE To assess the physiological effects of different PEEP levels with or without     scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal     surgery and receiving low-tidal volume ventilation.   "
15435|NCT03083444|"     To determine if there is an association between Porphyromonas gingivalis infection of dental     gingiva during primary tooth eruption and thickening of the radial artery intimamedial     layers. Thickening of these layers in infants could be a promoting factor for later     development of atherosclerosis.   "
15436|NCT03083431|"     Extremely premature infants are at risk of developing a potentially blinding eye disease,     called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser     surgery or injection of drugs into the eye balls, may prevent most but not all cases of     permanent ROP-mediated blindness. Both types of treatment are associated with significant     costs and side effects. An orally administered drug commonly used to treat hypertension,     propranolol, may be effective in halting progression of ROP to severe stages, as suggested by     preliminary data from two small studies. Propranolol has been used for decades not only in     adult patients but also in newborn infants with heart diseases. Moreover, it has been     licensed in 2014 for the use in newborn infants with hemangiomas in the European Union,     Switzerland and the United States. As severe (threshold) ROP is an overall rare disease, the     effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter     randomized controlled trial involving hospitals caring for extremely preterm infants of     diverse origin.   "
15463|NCT03083067|"     This is a multi-center, prospective, randomized and standard treatment parallel control     clinical trial.A total of 764 stable COPD patients according to GOLD will be recruited and     equally divided into two parallel groups, salvational intervention group (SI group) and     control group (CT group).On the foundation of basic medicine, inhaled ICS/LABA will be used     as an intervention drug for patients in SI group on severe air pollution days. It is aimed to     evaluate whether this novel treatment strategy will decrease the frequency of AECOPD per     year.   "
15757|NCT03079232|"     OCTAV is a medical device class I, not CE marked, based on a new technique for     high-resolution imager (cell) internal microstructures of all types of biological tissues in     vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the     dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the     tissue without sampling).   "
15437|NCT03083418|"     Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by     airflow limitation that is progressive and not fully reversible. Patients with acute     exacerbation of COPD must be hospitalized, as for further increase in airway resistance,     pulmonary alveolar excessive expansion, diaphragm fatigue and neural respiratory drive. In     recent years, Pulmonary rehabilitation is recognized as a core component in the comprehensive     management of COPD, EDP as a means of rehabilitation can alleviate diaphragmatic fatigue,     improve ventilation function, reduce the neural respiratory drive in patients with COPD     during hospitalization, but still lack of evidence based medicine. Surface EMGdi can     accurately evaluate neural respiratory drive, its detection is non-invasive, simple and     safety .Therefore,Neural respiratory drive by surface EMGdi can be used as an important index     for evaluating the therapeutic efficacy of AECOPD patients during hospitalization.      In the present study, about 40 patients with COPD will be recruited as research subjects .And     the investigators aim to explore the effect of EDP on diaphragmatic function and neural     respiratory drive in patient with AECOPD.Contrast analysis will be conducted to evaluate the     effects of EDP on patients with AECOPD, which may provide a reasonable basis for the clinical     application of EDP to AECOPD patients.   "
15438|NCT03083405|"     Sleep apnea is a common and serious health problem in the Polish population. According to     epidemiological data problem concerns about 7% of the adult population. The most common sleep     disorder is obstructive sleep apnea (OBS). The consequence of episodes of airway obstruction     and sleep fragmentation is an inefficient, lack of rest sleep, pathological daytime     sleepiness, falling asleep involuntarily, awakening with feelings of shortness of breath or     throttling. The direct consequences of sleep apnea are hypoxia, awakening, increased heart     rate and increased blood pressure. Frequent complications of obstructive sleep apnea (OSA)     are hypertension, stroke, cardiac arrhythmia, coronary artery disease, pulmonary hypertension     and heart failure. An additional problem in patients with sleep apnea is an increased     incidence of bruxism. It is one of the most common oral parafunctions. Bruxism is a common     problem; reports of prevalence range from 8-31% in the general population. The most common     symptoms of bruxism include: hypersensitive teeth, tooth wear, damage to dental restorations     (e.g. crowns and fillings), damage to periodontal and oral mucosa, masticatory muscle pain     and headaches. The etiology of bruxism is multifactorial and not fully understood. It can be     caused by local and general factors. The main general factors may be stress, emotional     disturbances and mental, neurological, hormonal disorders (eg. Hyperthyroidism),     gastrointestinal disease, allergies, medications, smoking, sleep disorders and snoring.     Arousals during the apnea episodes are considered to be a major cause of sleep bruxism. The     relationship between obstructive sleep apnea and sleep bruxism is still not clearly defined.     Further research is needed to help explain the relationship between these two phenomena,     which will enable further therapy in patients with coexisting OSA and sleep bruxism (SB).   "
15441|NCT03083366|"     In the first 3 months after spinal cord injury, patients will be randomized to receive and     implantable sacral neuromodulator that will stimulate bilateral S3 nerve roots. These     patients will be compared to those receiving standard neurogenic bladder care. Multiple     primary and secondary endpoints will be compared based upon urodynamic parameters, quality of     life measurements, and clinical outcomes.   "
15442|NCT03083353|"     The proposed study represents a crucial and important stage in translating basic research to     strategies for treating nicotine dependence. The investigation addresses an important public     health issue by testing an intervention - informed by basic research - that may lead to a     more effective and efficient treatment for smokers. The expected findings should provide     initial effect size data for the addition of isradipine to an integrated     psychosocial/behavioral and pharmacological smoking cessation intervention for smokers, and     thus provide the necessary data for a large-scale follow-up trial.   "
15443|NCT03083340|"     The proposed study addresses the potential utility of providing an accessible self-help     intervention for patients in a medical setting with an estimated diagnosis of MDD.     Specifically, the study will explore whether a) such an intervention can be effectively     implemented in a primary care setting and b) patients originally seeking medical attention     for an orthopedic problem will be willing to seek psychological treatment and, c) improvement     in depression symptoms will lead to improvement in upper and lower extremity functioning.   "
15444|NCT03083327|"     Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to     conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental     parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell     transplant.   "
15445|NCT03083314|"     This is a pilot study at the National Cancer Institute (INT) of Milan evaluated the     feasibility of selective axillary dissection (SAD) which preserved the lymphatic drainage of     the arm. Lymph nodes draining the arm are identified following radiotracer injection and     lymphoscintigraphy, a technique called axillary reverse mapping (ARM). SAD was found feasible     in 75% of patients. Furthermore only 9% had BCRL after SAD compared to 33% after axillary     lymph node dissection (ALND).   "
15446|NCT03083301|"     Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45     percent die in the first year of hospitalization. The most affected populations live in     Western countries like Europe or the USA.      It is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia     but must be objectified, preferably by ultrasound. Its basic treatment is based on a     lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia,     diabetes, ...), as well as an optimal medical treatment based on ACE inhibitors, B-blockers,     ARA2 (Sartans), spironolactone or digoxin.      When the optimal treatment is no longer working and that the cardiac desynchronization is     demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient     can benefit from a three-probes cardiac resynchronization to resynchronize the two     ventricles. The classic approach, performed by a cardiologist, is to perform an endovenous     procedure in order to place the 3 probes under local anesthesia.The first one goes in the     right atrium, the second one in the right ventricle and the third one goes in the left     ventricle. It is the placement of this third one that often causes trouble. It is more     difficult to place since it must pass through the coronary sinus, outside of the heart,     unlike the first two probes that are placed endocavitary. When the practitioner fails to     place the probe correctly or obtains inappropriate levels of detection, stimulation, or     impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy.      The CHU Brugmann Hospital is in favor of a mixed surgical approach. The probes are placed by     a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. If     that approach fails, the local anesthesia can be transformed into general anesthesia at the     same operative time and a mini-thoracotomy is performed.      The aim of this study is to evaluate the immediate impact of this surgical management within     the CHU Brugmann hospital, in patients suffering from cardiac insufficiency despite proper     medication.The hypothesis is that the mixed surgical approach improves the prognosis of     cardiac resynchronization.   "
15448|NCT03083275|"     The age-related loss in skeletal muscle mass is associated with substantial social and     economic costs as evidenced by impairments in strength, limitations in function, and     ultimately, physical disability and institutionalization (1-3). Improved knowledge of the     physiologic mechanisms that mediate impairments in physical functioning is crucial for     developing effective therapeutic interventions for preserving mobility and independence among     physically frail adults.      To date, pharmacodynamic markers that can be used in a clinical trial in mobility-limited     older adults are limited. Lean body mass measured by dual energy X-ray absorptiometry (DXA)     is frequently used in early phase clinical development of investigational anabolic drugs.     Although increase in muscle mass is considered to contribute to increased muscle strength,     this alone does not completely explain changes in physical performance. Thus, more direct     pharmacodynamic evidence associated with physical functioning is desired in early phase     clinical development decision making. Assessments of muscle power and fatigue can address     this need. The use of such assessments may provide more meaningful information as to the     pharmacodynamics effects of investigational drugs on muscle parameters.      This study will serve as a validation study, aiming to 1) examine the effect a 12-week     resistance program may have on muscle power and fatigue; 2) examine the effect of a 12-week     resistance exercise program on conventional measures of muscle function; 3) determine the     relationship between muscle power/fatigue and conventional measures of physical function.     Data from this study will serve as rationale for potentially including these measures as     pharmacodynamics markers in studies of novel therapies for skeletal muscle loss and/or     weakness.   "
15456|NCT03083171|"     In this randomized, double-blind, placebo-controlled study, either a single dose of     Adrecizumab (0.5, 2.0 or 8.0 mg/kg) or placebo will be administrated to 24 healthy male     volunteers during experimental endotoxemia.   "
15457|NCT03083158|"     Infection and cancer is a major cause of death and morbidity, and may be preventable through     vaccination. It is not fully understood at the molecular level why some people respond better     than others to vaccines until now the technology to assess this has not been available. This     has impaired vaccine development. The overall goal of the Human Vaccines Project is to     understand the 'rules' of how vaccines work. In this demonstration project the investigators     will vaccinate healthy adults with hepatitis B vaccine to start to understand better how it     works, ultimately helping with rational vaccine design in the future.   "
15458|NCT03083145|"     The objective of this study is to determine how the protein source and the physical form of     food consumed at breakfast impact food intake. Research will be conducted by assessing     feelings of hunger, food preference and blood glucose in healthy adults following the     ingestion protein-based (animal versus plant) drinks similar calorie and protein content.   "
19669|NCT03028116|"     The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial     that explored the safety and immunogenicity of single dose a allantoic split inactivated     seasonal influenza vaccine in healthy adults.   "
15449|NCT03083262|"     Dyspareunia, or painful intercourse, is one of the most commonly reported complaints in     postmenopausal women. One common cause of dyspareunia is vaginal atrophy (VVA), which occurs     in >50% of postmenopausal women. At the time of menopause, a lack of estrogen thins the     vaginal mucosa and lessons lubrication, making sex painful. Some women with vaginal atrophy     will also have high tone pelvic floor dysfunction (HTPFD) (also known as levator spasm).     Successful treatment of the sexual pain requires treatment of both vaginal atrophy and HTPFD.      How often vaginal atrophy and HTPFD coexist has not been studied. In fact, the prevalence of     HTPFD is unknown. This is most likely due to the fact that many clinicians are unaware of its     existence or how to diagnose or treat it. Also, sexual symptoms tend to be underreported due     to embarrassment or hesitation to seek care. HTPFD frequently coexists with other conditions     that cause pain like vaginal atrophy, endometriosis or interstitial cystitis. Treatment     includes treating both conditions. If only one is treated, then sexual pain is likely to     continue. There are several available treatments for HTPFD that have been studied including     physical therapy, botox and intravaginal diazepam.      This is an area where clinicians may be under treating a condition and limiting the     possibility of restoring normal sexual function to many women. Treating only vaginal atrophy     without appropriate evaluation and treatment of HTPFD leaves a cohort of women still     struggling with sexual pain. With a better understanding of the relationship between HTPFD     and vaginal atrophy, the investigators hope to bring awareness concerning the importance of     treating both in restoring normal sexual function.   "
15450|NCT03083249|"     Human papillomavirus (HPV) is the most common viral genital tract infection. The majority of     women and men who are sexually active will be exposed to a strain or strains of the virus.     While there are hundreds of viral strains, high risk strains are associated cervical and oral     cancers. According to the Centers for Disease Control (CDC), between 2008 and 2012 there were     38,793 deaths attributed to HPV related cancers. Vaccinations were created in an attempt to     prevent infection from the most common high risks strains of HPV. Gardasil/HPV-9 was created     to help prevent HPV related cancers and warts. The HPV-9 vaccine includes protection from 7     strains of HPV associated with 74% of HPV related cancers. While Gardasil was approved and     released in 2006, many men and women have not been vaccinated. A national immunization survey     in 2011 of teens 13-17 years old noted that only 60% of girls and 40% of boys have received     at least one vaccination in the series. While complete vaccination series is recommended, a     recent study found that a single dose of Gardasil when compared to placebo created a higher     level of serum antibodies in uninfected females.   "
15451|NCT03083236|"     The aim of the study is to evaluate the impact of parent based intervention on the language     of 2 to 3 year old children from socially disadvantaged populations with a clinical diagnosis     of primary language delay.   "
15452|NCT03083223|"     The subjects were placed consecutively in random order in the five different positions by     drawing lots. Oxygen saturation (SaO2) and vital signs (pulse rate, respiratory rate,     systolic blood pressure, diastolic blood pressure and body temperature) were measured in each     position at 10, 25 and 40 minutes.   "
15453|NCT03083210|"     Clinical data from uncontrolled retrospective or prospective studies have initially     demonstrated antiproliferative effects of lanreotide in limited number of patients lanreotide     Autogel® has recently been approved in more than 40 countries for the treatment of GEP-NET     patients, this is based on the results of CLARINET study, the largest prospective trial to     evaluate the antiproliferative effects of lanreotide Autogel® in subjects with nonfunctional     GEP-NETs. The study enrolled 204 subjects (101 subjects were randomized to lanreotide     Autogel® group and 103 subjects were randomized to placebo group, came from 14 countries)     with well or moderately differentiated non-functioning GEP-NETs, including pancreatic and     gastrointestinal tumors, and defined as having less than 10% of proliferation marker Ki67.     The study had shown that treatment with lanreotide Autogel® significantly prolonged     progression-free survival in subjects with GEP-NETs compared to treatment with placebo in the     primary analysis (median progression-free survival, not reached vs. 18.0 months, P< 0.001 by     the stratified log-rank test; hazard ratio for progression or death with lanreotide vs.     placebo, 0.47; 95% confidence interval (CI), 0.30 to 0.73) [5].      The indication of GEP-NETs granted for lanreotide Autogel® in the USA is for the treatment of     patients with unresectable, well or moderately differentiated, locally advanced or metastatic     gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival;     and in the European Union (EU) is for treatment of grade 1 and a subset of grade 2 (Ki67     index up to 10%) gastroenteropancreatic neuroendocrine tumors of midgut, pancreatic or     unknown origin where hindgut sites of origin have been excluded, in adult patients with     unresectable locally advanced or metastatic disease. The addition of an indication for the     treatment of patients with GEP-NETs has been approved by more than 15 other authorities     including in Canada, Australia and some Asian countries, etc.   "
15464|NCT03083054|"     The main objective of this work is to conduct a clinical study for the development and     application of a vaccine with autologous dendritic cells submitted to electroporation with     Wilm's tumor 1 (WT1) messenger ribonucleic acid (mRNA), as an adjuvant treatment of high-risk     Myelodysplastic Syndromes and Acute Myeloid Leukemia, aiming to delay the progression of the     disease or its relapse and increase overall and event-free survival.   "
15758|NCT03079219|"     The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the     proportion of patients with Complete Response in the 120 hours following AC chemotherapy.   "
15454|NCT03083197|"     Study type: Randomized Control Treatment Trial      Study population: Male and female patients with ≥15 years of age and acute scrub typhus      Duration: 2 years      Study Design: Prospective, open-label, randomized-controlled treatment trial in patients ≥15     years old admitted to hospital with acute scrub typhus. Randomization into 3 oral treatment     arms (each n=59 patients, total n=177): i) 7 days of doxycycline, ii) 3 days of doxycycline,     and iii) 3 days of azithromycin      Primary Objective: To evaluate the clinical and microbiological responses in scrub typhus     patients to three oral treatment regimens: 7 days of doxycycline, 3 days of doxycycline, and     3 days of azithromycin      Secondary Objectives:        1. To perform pharmacokinetic/pharmacodynamics (PK/PD) characterization of the therapeutic          responses for doxycycline and azithromycin, incl. serial bacterial load measurements.        2. To define clinical, bacterial, pathophysiological and pharmacological factors associated          with disease severity, fever-clearance times (FCT), treatment failures and          relapse/re-infection.        3. To determine the minimum inhibitory concentrations (MIC) of clinical Orientia          tsutsugamushi isolates to doxycycline, azithromycin and chloramphenicol, using in vitro          growth-inhibition assays        4. To genotype all clinical isolates using whole genome sequencing for comparative          genomics.        5. To dissect the natural immune response in scrub typhus, using antigen-specific cellular          immune and antibody studies, and cytokine profiling   "
15455|NCT03083184|"     The purpose of this study is to assessed the efficacy of a combined solution of ethanol (4%)     and low molecular weight heparins LMWH in preventing tunnelled dialysis catheter infection in     chronic hemodialysis patients   "
15459|NCT03083132|"     Freezing of gait is a late stage complication of Parkinson's disease in which patients note     that their feet feel stuck or glued to the ground. This can lead to imbalance and falls and     the secondary complications that can result from falls such as fractures and     hospitalizations. While levodopa can help freezing of gait in some patients, it does not help     in all, and the dose needed to treat freezing may be limited by side effects of the     medications. Currently there are no treatments targeted towards freezing of gait and the goal     of this research is to see if Modafinil could be one such drug to help freezing of gait in     Parkinson's disease.      20 subjects aged 18 or older with idiopathic Parkinson's disease with freezing of gait will     be asked to enroll in the study from the patient population in the movement disorders clinic     at UAMS. Subjects will be assigned randomly 1:1 to an early start and delayed start arm of     the study. In the early start arm subjects will receive 24 weeks of 50 mg oral daily     Modafinil while subjects in the delayed start arm will receive 12 weeks of placebo followed     by 12 weeks of 50 mg oral daily Modafinil. Assessments will be performed prior to initiation     of medication at the screening visit, as well as at 6 weeks, 12 weeks, 18 weeks and 24 weeks     of the treatment phase, in addition to 2 weeks after discontinuation of medications. The     assessments will include questionnaires to determine the frequency and severity of freezing     of gait, level of mood, anxiety and apathy and quality of life, physical examination and     tests of cognitive function. Objective assessment of patients walking will be conducted using     a pressure sensor impregnated mat at each visit.   "
15460|NCT03083119|"     In this study, typical cases of coronary heart disease are selected. They will be intervened     by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.   "
15461|NCT03083093|"     In this study the investigators will evaluate whether more careful reading (than the current     standard) of routine computerised tomography pulmonary angiography (CTPA) performed in the     clinical work-up of suspected (pulmonary embolism (PE) will differentiate patients with acute     PE from those with more chronic or acute on chronic PE, which could be indicative of the     presence of chronic thromboembolic pulmonary hypertension (CTEPH)   "
15462|NCT03083080|"     Traditionally, video-assisted thoracic surgery is performed under general anesthesia with     double-lumen endotracheal tube. However, the complications associated with this large tube as     well as inhalation anesthetics are frequently reported. Therefore, currently there is a trend     toward non-intubated anesthesia methods for video-assisted thoracic surgery, which includes     thoracic epidural block, peripheral nerve block, local anesthesia, local combined with     peripheral nerve block, etc. Thoracic epidural block demands a high technique, but still     risks catastrophic neurological complications in case of accidental dural puncture. Local     anesthesia, perhaps more straightforward, however may need supplemental analgesia during     incision, which will inevitably interrupt surgery and negatively affect the patients. This     study aims to apply ultrasound guidance during local anesthetic injection for local     anesthesia-based video assisted thoracic surgery, which helps inject the local anesthetic     into the key intercostal nerve plane to provide more specific and precise blockade, thus     avoiding the chance of blind injection. At the same time, ultrasound guidance has the     potential to reduce the risk of systemic toxicity, prolong the duration of analgesia     postoperatively, and facilitates postoperative recovery.   "
15478|NCT03082872|"     To introduce a novel external-fixation technique using the combination of K-wires and cement,     and the objective of this report is also to compare the technique with conventional open     transfixion pinning.   "
15759|NCT03079206|"     The proposed study intends to compare the outcome of food challenge in hazelnut allergic     patients with the outcome of basophile activation tests using hazelnut extract and     components.   "
15465|NCT03083041|"     This is a multi-center, open-label, Phase II study of intravenous (IV) SHR-1210 at 200mg,q2w     in combination with Apatinib at two dose levels in subjects with locally advanced or     metastatic non-small cell lung cancer (NSCLC).      The study is composed of two parts. Part 1 of the study will determine the safety     ,tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib.      Part 2 includes a randomized comparison of Apatinib 250mg/d or 500mg/d plus SHR-1210 .      Subject's tumors will be screened at baseline for EGFR mutations, EML4-ALK translocation, and     PD-L1 expression.But positive tumor PD-L1 expression will not be required for enrollment.   "
15466|NCT03083028|"     This study will determine whether operative management confers improved short and long−term     outcomes for patients with isolated AO type 44−B1 distal fibula fractures when compared with     non−operative management.   "
15467|NCT03083015|"     This study compared the efficiency of pulp revascularization and MTA apexification in the     treatment of patients with necrotic immature anterior teeth.   "
15468|NCT03083002|"     Purpose of the study is to determine transcriptomics, metabolomics and proteomics features of     liver cirrhotic tissue in patients with hepatocellular carcinoma (HCC) and to find a     correlation with the risk of developing HCC and survival.   "
15469|NCT03082989|"     Italy is the European country with the minor penetration of FFR as compared to the number of     percutaneous coronary intervention.      Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted     a prospective nationwide study to describe the patterns of the use of FFR in an unselected     real-world population and to to assess the reasons, on clinical decision making, driving     operators in the use or not of the FFR.   "
15470|NCT03082976|"     A prospective, multi-centre, epidemiological observational study designed to evaluate the     prevalence of BRCA1 and BRCA2 (BReast CAncer gene) mutations in current and newly diagnosed     ovarian cancer patients across different countries in the Gulf region. This study will also     describe the epidemiological features for the disease for the enrolled patients.   "
15481|NCT03082833|"     Phase II trial of AZD2014 in TSC1/2 mutated or TSC1/2 null GC patients as second-line     chemotherapy   "
15482|NCT03082820|"     The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve     injuries. Since previous studies found altered latencies and amplitudes of PREP in     generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study     investigates if these alterations are detectable in unilateral peripheral nerve injuries as     well.   "
15483|NCT03082807|"     The present study aimed to determine the effects of negative-calorie diet supplemented with     exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie     diet with exercise among elderly adult men with abnormal weight gain.   "
15471|NCT03082963|"     The overall goal of this project is to test the feasibility of performing real-time     electrogram morphology recurrence (EMR) mapping in patients with persistent atrial     fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The     Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to     identify potential sites for ablation. Furthermore, this study could help demonstrate the     efficacy of this technology's ability to terminate or slow AF.      The Investigator will test this technology on ten subjects undergoing a second ablation     procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable     activity and ablate the area. The Investigator believes that the study could produce acute AF     termination or AF cycle length slowing. In addition to testing the real-time electrogram     morphology recurrence mapping, the study would also like to determine the acute effects of     radiofrequency ablation of areas of high recurrence rates and determine long term freedom     from AF following ablation of areas of high recurrence rates.   "
15472|NCT03082950|"     HPV infections may be responsible for different types of cancer in females. Primary Goal of     the study was to identify the prevalence of an hpv affiliation in retrospective-prospective     analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.   "
15473|NCT03082937|"     The primary objectives of the study are to assess the mass balance recovery after a single     dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples     for metabolite profiling and structural identification in healthy male subjects.   "
15474|NCT03082924|"     Pulmonary rehabilitation is recognized as a core component of the management of individuals     with chronic obstructive respiratory disease, which has become first-line treatment besides     drug therapy. However, in the current clinical evaluation system of pulmonary rehabilitation,     there is still a lack of simple, objective index,which can be monitored at any time.Neural     respiratory drive , as an important physiological index, is closely related to the symptoms     and the severity of the disease. It may be a sensitive indicator to evaluate the     effectiveness of pulmonary rehabilitation. Surface EMGdi can accurately evaluate neural     respiratory drive , its detection is non-invasive, simple and safety . In recent years, with     the development of signal detection and analysis technology, EMG recording is more stable,     but as the related research samples were low, surface diaphragm EMG has not yet the     establishment of standardization. Therefore, based on the previous work, the project was     carried out in a multicenter randomized controlled study,in which the stable stage of COPD     patients were included in different ways of pulmonary rehabilitation training, a     comprehensive clinical assessment will be conducted before and after training. Compared with     the traditional evaluation methods and standard esophageal diaphragmatic electromyography,     surface EMGdi detect the changes of neural respiratory drive in patients with COPD,that can     help to explore the application value of surface EMGdi in the assessment of chronic     obstructive pulmonary disease with pulmonary rehabilitation, to provide a basis for the     promotion of the diaphragm and the optimization of pulmonary rehabilitation program.   "
15475|NCT03082911|"     Objective: To assess the effectiveness of a brief telephone intervention added to an post     invitation letter in the participation rate to a colorectal cancer screening program.      Methods: Randomized controlled trial. This study is framed inside the colorectal cancer     screening program of Catalonia, concretely in the region of Vallès Occidental. This program     is directed to men and women from 50 to 69 years. The screening test used is the fecal     immunological test (FIT) that is offered every 2 years. If the screening test is positive, a     colonoscopy with sedation is offered as a diagnostic test.   "
15476|NCT03082898|"     The proposed study is intended to inform the hypotheses that (1) regular dosing of     exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory     individuals with SCI, including decreased pain and spasticity, improvements in bowel and     bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of     exoskeleton walking will facilitate neurological or functional recovery in some individuals     with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled     by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces     required for community ambulation.   "
15477|NCT03082885|"     A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration     in patients with HBV-related Acute-on-chronic liver failure.   "
15479|NCT03082859|"     Exercise is considered one of the three cornerstones of type 2 diabetes (T2D) care programmes     (together with diet and medication), yet the majority of individuals with T2D do not achieve     the minimum recommended levels of physical activity. Two of the key barriers to exercise     appear to be a 'lack of time' and the high levels of perceived exertion and fatigue. At     Ulster University, it has recently been demonstrated that a modified high-intensity interval     training (HIT) intervention, consisting of 10-min of low-intensity cycling interspersed with     two 20-s 'all-out' sprints (reduced-exertion HIT; REHIT), was effective at improving insulin     sensitivity in sedentary men over six weeks. Importantly, these benefits were observed     despite the very low time commitment (just 10-min per session) and relatively low ratings of     perceived exertion ('somewhat hard'). As REHIT is associated with substantial muscle glycogen     breakdown, we hypothesise that this exercise mode may also acutely improve glycaemic control     in patients with T2D. This study will:        1. Examine the acute impact of REHIT, compared with a no-exercise control, on 24-hour          glycaemic control under dietary-controlled but otherwise 'free-living' conditions using          continuous glucose monitoring.        2. Compare the effects of REHIT with currently recommended levels of aerobic exercise and a          previously recommended HIT model, both of which have been shown to improve 24-hour          glycaemic control in T2D.        3. Collect information on individual's perceptions of each exercise mode through measures          of affect, motivation, perceived exertion, fatigue, enjoyment and attentional focus.   "
15480|NCT03082846|"     Postoperative conventional radiation at 60 Gy/30f is currently still considered the standard     radiotherapy mode for high-grade gliomas; however, the efficacy is still unsatisfactory.     Studies in recent years have shown that hypofractionated simultaneous integrated     boost-intensity modulated radiation therapy (SIB-IMRT) has certain survival benefits over     other fractionation methods; but, the best hypofractionation mode and its efficacy have not     been confirmed. The purpose of this study is to investigate the maximum tolerated dose (MTD)     of hypofractionated SIB-IMRT with stepwise escalating of doses combined with temozolomide     (TMZ) for the treatment of malignant gliomas.   "
15487|NCT03082755|"     Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses     caregivers, and often results in prescriptions for harmful antipsychotics. Effective     treatments are lacking because of limited knowledge of the etiology of nighttime agitation.     The investigators propose a clinical trial to better elucidate whether a sleep disorder,     restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with     gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces     restless legs syndrome behaviors, and reduces antipsychotic medications.   "
15488|NCT03082742|"     Chronic kidney disease (CKD) patients often have associated systemic hypertension due to     volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in     this population. One of the major complications of CKD is mineral and bone metabolism     disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D     deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid     hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and     mortality among patients with CKD. According to diuretic mechanism of action, sometimes     increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of     thiazide), it is expected that the serum calcium may be altered, even within the range of     normality, with consequent impact on the levels of PTH. Although most studies have shown that     the use of thiazide diuretics decreases the risk of fractures, some showed the opposite.     Similarly, although most studies have shown increased risk of fracture in association to loop     diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study     in a population of CKD, showed that furosemide was directly related to increased calciuria     and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However,     certain issues are still not completely solved, for example, the interference of renal     function itself on calciuria. It is possible that calciuria is not a so simple explanation     that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH     levels. Better understanding of the exact relationship between the use of diuretics and the     impact on CKD-MBD may be an alternative intervention, easily accessible and relatively     inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically     hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.   "
15489|NCT03082729|"     The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular     inflammation, cardiometabolic biomarkers and body composition in patients with     moderate-severe psoriasis.   "
15490|NCT03082716|"     Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial     preservation and minimise myocardial swelling ,while providing a motionless and bloodless     field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still     preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is     thought to be more time consuming since it is given with interrupted doses, . Even when     advancement has came along the field of myocardial protection and cardioplegia solutions with     the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in     1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and     less time consuming . Many Surgeons haven't change their practice possibly due to paucity of     studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting     reports regarding the superiority of different cardioplegia solution.The investigators aim to     provide evidence that will help paediatric cardiac surgeons to choose the optimal solution     for their practice .   "
15491|NCT03082703|"     This randomized study aims at examining the impact of text messaging in the management of     non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), a disease     frequently associated with obesity and varying components of metabolic syndrome including     diabetes mellitus, hypertension, and dyslipidemia. With rising incidence of obesity in the     US, NAFLD and NASH are rapidly increasing with currently the second etiology for liver     transplantation in the US. The objectives of this protocol are to a) prospectively enroll     patients with NAFLD and NASH; b) randomize them to receiving text messaging to help manage     obesity and other components od metabolic syndrome in addition to standard clinical care or     receiving only standard clinical care; and c) follow up these patients at the end of 3 months     period for weight loss, blood pressure control, HBA1c, and liver enzymes. The immediate aim     of this protocol is to develop the pilot data on the usefulness of text messaging in the     management of NAFLD and NASH. The long-term goals of this research are to establish text     messaging as a beneficial intervention in the management of weight loss and control of risk     factors of NAFLD and improve outcomes of these patients with NAFLD and NASH.   "
15492|NCT03082690|"     The purpose of this study is describe the safety and single-dose pharmacokinetics of     rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue     biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess     the luminal distribution of IQP-0528 in the rectum. Sixteen healthy volunteers will receive a     single rectal dose of DuoGel, followed by blood, tissue and fluid sampling over the following     72 hours.   "
15493|NCT03082677|"     This is a single arm open label phase 2 study evaluating the potential effect of ixazomib on     the prevention of recurrent or late acute graft-versus-host disease (GVHD) and chronic GVHD     at 1-year following reduced intensity (RI) or non-myeloablative (NMA) allogeneic     hematopoietic stem cell transplantation (HSCT) for the treatment of hematologic malignancies.   "
15494|NCT03082664|"     This is a randomized controlled trial. Patients with a condition that increases their risk of     a wound complication will be approached for inclusion in the trial. Each participant agreeing     to study inclusion will be randomized to either suture alone or to closure of their skin     incision with suture and then with prophylactic placement of a wound vac (PICO).   "
15495|NCT03082651|"     The proposed study will investigate the effect of alternating footwear model and workout-type     on the occurrence of running-related pain. To achieve this goal participants will be randomly     assigned into one of four different groups who will perform: 1) the same workout throughout a     week in the same running shoe model, 2) alternating workout-types throughout the week in the     same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4)     alternating workouts in alternating shoes. Participants will be characterized based on body     alignment, strength, injury and training history. Pain and injury status will be monitored.   "
15496|NCT03082638|"     The scientists working on this study want to use blood samples to identify components in     blood, such as protein, lipids and their breakdown products to determine if they can be used     for diagnosing Gulf War Illness (GWI). An additional goal is to examine the relationship of     changes in these markers with the exposures and symptoms associated with GWI.      The Scientists will also prepare RNA and DNA from the blood samples for genetic analyses of     certain proteins known to increase the risk for GWI. This information will be one of the     factors included in the analysis of results from the protein studies.   "
15497|NCT03082625|"     Oral magnesium supplementation has been widely used in the treatment of muscle cramps. Muscle     cramps are common in dialysis patients but are not satisfactorily prevented by oral     magnesium. Transdermal administration of magnesium has been promoted as a potential treatment     for muscle cramps but this has not been investigated rigorously. We aim to evaluate the     effectiveness of transdermal magnesium supplementation in reducing cramp frequency and     severity. We will recruit current haemodialysis patients who suffer from muscle cramps into a     randomised, placebo-controlled, cross-over design trial. Each intervention period will last 8     weeks with a 4-week washout period in between. We will measure muscle cramp frequency,     duration and severity as the primary outcomes.   "
15498|NCT03082612|"     The purpose of this study is to evaluate the feasibility and acceptability of an intervention     designed to reduce psychological distress among African Americans during treatment for     cancer. This knowledge will inform a larger test of an intervention tailored to decrease the     psychological distress experienced among African Americans diagnosed with late-stage cancers.     Study participants will take part in 4 data collection sessions and also asked to view and     provide feedback on audio- or video recorded vignettes of African Americans use of hymns to     reduce psychological distress during the diagnosis and treatment for cancer. Participants     will also be asked to complete interviews at the 4 time periods which will include     open-ended, semi-structured interviews, and structured interview questions. This study     addresses the need to understand the ways in which narrated messages of hope through hymns     and African American religious song in particular, reduce psychological distress.   "
15499|NCT03082599|"     In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott     Medical Optics) helping to improve the sharpness of vision at near, intermediate and far     distances reducing the need of glasses after cataract surgery. It is available in both a     non-toric version and a toric version for patients with astigmatism. The difference between     this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal     IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points;     therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was     compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better     intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near     vision (Symfony patients were able to read two additional, progressively smaller lines     compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a     MIOL is the visual performance at near.B One option to deal with this potential shortcoming     is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred     to as nano-vision or mini mono-vision.   "
15500|NCT03082586|"     The aim of this trial is to find the maximum tolerable dose of radiation that can be     delivered combined with chemotherapy (DDP & Paclitaxel) in patients with inoperable or     medically unresectable esophageal cancer.   "
15502|NCT03082560|"     The study's Primary Objective is to design and validate a grading system for objective and     accurate assessment of lichen planopilaris.      Secondary Objectives:        -  To assess change in symptoms such as pain and itch using a Numeric Rating Scale(NRS)          scores and quality of life using the Dermatology Life Quality Index (DLQI) scores        -  To correlate this grading system with patient skin biopsies evaluating disease activity          on a microscopic level        -  To correlate this grading system with digital global photography and trichoscopy   "
15503|NCT03082547|"     To study the clinical characteristics of headache patients with pericranial myofascial     trigger points(MTrPs),and to explore the possible pathogenesis of MTrPs,investigators hope to     find the possible electrical biomarkers for clinical diagnosis and treatment, and to improve     the effect of headache treatment.   "
15504|NCT03082534|"     This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to     evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients     with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1     inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory,     cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm     (Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25     in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be     enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive     Cancer Center, University of Michigan Comprehensive Cancer Center, and University of     Washington Siteman Cancer Center.   "
15505|NCT03082521|"     This PAR (participatory action research) study to improve antibiotic prescribing quality in a     GPC (general practitioner cooperative) during OOH-care (out-of-hours-care) uses a mixed     methods approach using qualitative as well as quantitative techniques. In a first exploratory     phase we will work on partnership development and mapping the existing issues. In a second     phase the focus will be on facilitating change and implementing interventions through PDSA     (plan do study act) cycles. In a third phase outcomes on prescribing quality during and     outside office hours will be evaluated. Equally important is the process evaluation and     theory building on improving antibiotic prescribing through PAR.   "
15506|NCT03082508|"     AUGMENT-HF II is a study to evaluate the efficacy and safety of the Algisyl device. The     purpose of this study is to investigate Algisyl employed as a method of left ventricular     augmentation and restoration in patients with dilated cardiomyopathy.      Algisyl will be injected into the myocardium under direct visualization during the surgical     procedure. Structural abnormalities in the heart are known to play a central role in HF, and     clinical evidence supports a strong causal relationship between cardiac chamber dilation and     heart failure. Because dilation, and not contractile dysfunction, appears to be responsible     for the severity of the disease, the mitigation or prevention of the deleterious structural     abnormalities of the left ventricle appears to be an important therapeutic target for     patients with this life threatening illness.      Hence, a therapy that specifically reduces LV wall stress, targets LV dilatation and LV     remodeling may offer an important new alternative in the treatment of heart failure. Algisyl     is being investigated based on evidence that suggests an ability of the implants to reduce     wall stress, reshape the LV chamber and reduce the LV chamber size as well as prevent the     progressive ventricular dilation and remodeling associated with HF.      The physiologic response to progressive exercise using direct measures of ventilation and gas     exchange via the cardiopulmonary exercise test is an important diagnostic tool in the     management of the patient with HF, quantifying responses to therapy, and as a reliable     prognostic utility for predicting outcomes in patients with HF.      Numerous studies have established the strong association of peak VO2 with mortality and     morbidity risk in HF. Peak VO2 conceptually is considered an overall global marker of     cardiopulmonary health and is a reflection of the degree of impairment in ventricular     function ( the heart's pumping capacity), oxygen delivery and oxygen utilization.      Hence, employing the change in peak VO2 as a primary endpoint in this clinical study provides     a strong objective measure that can be interpreted in independent blinded fashion, to     evaluate the result of the therapeutic intervention and provide an equally strong assessment     of the prognostic implications for patients in the study.      This clinical evaluation is intended to provide confirmatory evidence of the effectiveness     and safety of the device Algisyl in patients with advanced heart failure.   "
15507|NCT03082495|"     This study is designed to investigate if aerobic exercise during and after neoadjuvant     chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.      Rectal cancer patients will be randomly assigned to aerobic exercise or usual care. Patients     in the aerobic exercise group will be asked to complete 3 supervised high-intensity aerobic     interval training (HIT) session/week during NACRT and ≥ 150 minutes/week of unsupervised     aerobic exercise after NACRT.      Primary hypothesis: aerobic exercise during and after NACRT, compare to usual care, will     result in significantly better cardiorespiratory fitness.   "
15508|NCT03082482|"     The proposed pilot study seeks to address the smoking treatment needs of people living with     HIV/AIDS (PLWHA) by evaluating the feasibility and preliminary efficacy of a smartphone     delivered automated video-assisted smoking treatment (AVAST). AVAST will enable smoking     cessation treatment content to be presented with voice/audio, images, videos, and text in an     interactive, structured format anytime and anywhere. This automated treatment approach is     designed to enhance treatment engagement and facilitate abstinence from smoking among PLWHA.     Participants will be recruited from the University of Oklahoma Health Sciences Center (OUHSC)     clinics providing care to HIV+ individuals (e.g., the Infectious Diseases Institute).   "
15509|NCT03082469|"     Severe acute pancreatitis (SAP) has a mortality of up to 42%. The outcome of SAP is related     to the development of SIRS and consecutive organ failures. Due to the lack of a causative     therapy except the removal of bile duct stones, therapy is predominantly symptomatic.      With regard to a marked inflammatory response (cytokine storm) during the early phase of     SAP extracorporeal cytokine removal is a promising therapeutic approach.      This prospective case control study investigates the impact of early extracorporeal cytokine     adsorption with the CytoSorb®-device on haemodynamics (primary endpoint) and several     secondary outcomes.   "
15510|NCT03082456|"     The molecular breast imaging (MBI) is a potential modality to screen breast cancer. In this     study, we compare and evaluate the recall rate/diagnostic efficiency of MBI, mammography and     breast sonography, and aim to determine best ways of breast cancer screening.   "
15532|NCT03082170|"     The investigators hypothesize that partial robotic tongue base resection surgery and / or     soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to     characterize the dysphagia The investigators will locate participants undergoing this surgery     more than six months ago.The investigators will test their swallowing by fiberoptic     endoscopic evaluation of swallowing (FEES) and let participants fill out a questionnaire     regarding swallowing disorders swallowing dysfunction questionnaire (SDQ). Also the     investigators will use data collected from participants who have undergone this surgery and     already had these tests due to swallowing complaints.   "
15533|NCT03082157|"     Mighty Men is a 6-month faith-based weight-loss intervention for obese African American men     35-74 years old being conducted in Atlanta, GA.   "
15511|NCT03082443|"     To evaluate the effectiveness of a group intervention in the nutritional profile, in the     stress and in the quality of life of patients in cardiopulmonary rehabilitation. Method:     Randomized clinical trial using a semi-structured interview, sociodemographic and     anthropometric data collection, with 164 participants divided into a control group and     intervention group, the Food Frequency Questionnaire, the Lipp Adult Stress Symptom Inventory     (ISSL) ) And the SF-12 Quality of Life Assessment Questionnaire. To verify the difference in     nutritional profile, stress levels and quality of life between the groups, the chi-square     test will be used for categorical variables and within each group the comparison between the     moments will be through the MC Nemar test. In the quantitative variables the evaluation of     the interaction between group and time will be through Variance Analysis using the design in     Repeated Measures. Considering a significance level p <0.05. Expected Results: It is believed     that psychological and nutritional intervention in patients participating in therapeutic     groups helps them to elaborate questions regarding the difficulties of coping with the     disease in the daily routine and to understand the importance of lifestyle care and healthy     habits.   "
15512|NCT03082430|"     This monocentric protocol is designed to evaluate the efficacy of therapeutic management of     symptomatic knee osteoarthritis (resistant to medical first-line treatment) by     intra-articular injection of autologous PRP prepared in the same procedure and using a     dedicated CE marked medical device and a validated and reproducible method of preparation   "
15513|NCT03082417|"     The PAINFREE (Improving PAIN control following FRactures; towards an Elder-friendly Emergency     department) Initiative is a patient-centered multifaceted intervention which aims to improve     pain management in patients 75 years and older presenting with a fracture at 7 Emergency     Department of participating Montreal hospitals:        1. Montreal General Hospital        2. Royal Victoria Hospital        3. Ste Mary's Hospital        4. Hôpital de Verdun        5. Hôpital du Sacré-Coeur de Montréal        6. Jewish General Hospital        7. Lakeshore General Hospital   "
15514|NCT03082404|"     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney     function and in its most advanced stage is called chronic renal failure. Although     hemodialysis replace some kidney function, patients suffer some alterations characterized by     uremic syndrome typically expressed by: motor neuropathy and/ or autonomic neuropathy,     cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thereby,     the the adoption of physical exercise should be encouraged. However, it is known that the     ability to exercise the subject in hemodialysis is low and they present weakness of the     peripheral muscular system, including inspiratory muscles. The aim of this study is to assess     the effects of inspiratory muscle training (IMT) on ventilatory muscle strength and     functional capacity of patients with chronic kidney disease in hemodialysis. For this the     following assessments will be performed before and after intervention: six-minute walk test     to functional capacity; Kidney Disease and Quality of Life - Short Form questionnaire for     quality of life; flow-mediated dilatation to endothelial function; sit-to-stand test for     proximal strength of lower limbs. The subjects will be randomized into two groups, IMTG     (inspiratory muscle training group) and CG (control group). The first will receive the IMT,     for five weeks, three times a week, during hemodialysis session and the patients will be     oriented to realize more three days at home. The control group only will be evaluated and     re-evaluated. Expected results at the end of the protocol with IMT are: increased inspiratory     muscle strength; longest distance covered on the six-minute walk test; improved quality of     life; increased muscle strength of the lower limbs; improved endothelial function.   "
15516|NCT03082378|"     Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are     the major factors that influence the survival. Obesity has been reported was significantly     correlated with increased risk of developing HCC.      In this study, we will analysis the association of multiple obesity index(waist     circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.   "
15517|NCT03082365|"     The patients with chronic kidney disease suffer from many oral problems affecting the quality     of life. The aim of our study is to assess their oral health to provide the proper management     and increase their awareness   "
15518|NCT03082352|"     The purpose of the study is to compare the bioavailability of a generic product of metoprolol     with that of a reference product when administered to healthy volunteers under fasting     conditions. The test product is BF-Metoprolol Tablets 100mg manufactured by Bright Future     Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited and the     reference product is Betaloc Tablet 100mg. The plasma kinetic data of metoprolol obtained     from two formulations will be used to access the interchangeability of the products.   "
15519|NCT03082339|"     Scientific and clinical data report about shortening of QTc-interval in patients treated with     cortisone. Peal et al. analyzed chemical suppression of long QT syndrome (Type 2) in an in     vivo zebrafish model. Their study revealed that flurandrenolide reproducibly suppressed the     long QT phenotype via the glucocorticoid signaling pathway. In contrast to treatment with     dexamethasone and testosterone, treatment with pure mineralocorticoid deoxycorticosterone     acetate did not suppress long QT phenotype. Knockdown of the glucocorticoid receptor or,     conversely, of the androgen receptor showed that flurandrenolide acting through the     glucocorticoid receptor shortens ventricular action potentials. The mechanism is distinct     from trafficking rescue of the defective zebrafish-ERG channel. The authors discuss that a     drug normalizing repolarization would be a novel therapeutic tool in long QT syndrome and     conclude that glucocorticoids could be expected to aid in the acute management of patients     with long QT syndrome, e.g. in episodes of arrhythmic storm. In addition, corticoid induced     normalization of the QT interval is reported in a patient with drug-induced prolongation of     the QTc interval. Brostoff et al. report on a patient suffering from mucocutaneous     leishmaniasis treated with sodium stibogluconate. During therapy, the QTc interval prolonged     and returned to normal within 4 days after starting glucocorticoid therapy with prednisolone     20 mg twice daily.      Interrogation of the study:        -  shortens cortisone the QTc-interval?        -  how long is the interval until shortening of QTc-interval?        -  is the effect prolonged?        -  is the effect dose dependend?   "
15520|NCT03082326|"     Shock is a common condition in critical care unit (ICU). It is extremely important that the     patient accepts early goal-directed therapy (EGDT) treatment in the early stage of shock.     However, several studies failed to demonstrate that the well used variables such as CVP and     others could direct to a better treatment. In recent years, critical care ultrasound (CCUS)     has been respected as a reliable noninvasive tool and widely used in ICU practice. With CCUS     the investigators can accurately acquired the detailed information of the characteristic of     the hemodynamics and lung pathology (the systole and diastole function, volume status, valve     insufficiency, lung, edema, consolidation, and pleural effusion, etc.). To the investigators     knowledge, there is no study investigating the epidemic of such ultrasonic variables and its     value to predict to outcome. The aim of this study is to investigate the epidemic and the     prognostic value of CCUS Based Characteristic of Hemodynamic and Lung pathology in Early     Stage of Shock in patients admitted in ICU.   "
15521|NCT03082313|"     The objective is to pilot test the effectiveness of an evidence-based intervention to promote     positive neurodevelopmental outcomes in infants at risk for developmental delay. The     intervention promotes movement experience from 3 months to sitting onset.   "
15522|NCT03082300|"     The objective of this study is to evaluate the bioequivalence of a tablet formulation versus     a capsule formulation of ASP8273 following a single dose under fasted condition in subjects     with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)     mutations. The study will also evaluate the safety and tolerability of a tablet formulation     as a single dose and a capsule formulation as a single and multiple dose of ASP8273 in     subjects with NSCLC harboring EGFR mutations.   "
15523|NCT03082287|"     The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively     measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a     protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the     diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and     Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel     Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical     picture. This study will estimate the predictive values of a negative (NPV) and positive     (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.   "
15524|NCT03082274|"     Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy     scheduled for repeat biopsy.      Subjects must have had their negative index prostate biopsy procedure within 30 months of     being scheduled for their repeat biopsy.      All enrolled subjects will have all core tissues from the initial negative biopsy blinded and     tested with the assay.      All subjects will have serum and plasma samples obtained prior to DRE, and a urine sample     collected immediately following DRE but in advance of the repeat biopsy; samples will be     blinded and sent to MDxHealth for evaluation.   "
15525|NCT03082261|"     The purpose of the study is to evaluate sustainable pain control utilizing a multiple     waveform enabled neurostimulator in patients with chronic, intractable pain of the trunk     and/or limbs.   "
15548|NCT03081962|"     A prospective randomized clinical trial will be performed. Patients will be randomized in 2     groups. The experimental group will undergo the combined application of intraperitoneal     irrigation with clindamycin and gentamicin solution, fascial closure with     Triclosan-impregnated sutures and application of mupirocin ointment over the skin staples, in     addition to the standard care measures. The control group undergo only the standard care     measures.      Incisional surgical-site infection will be investigated.   "
16152|NCT03074071|"     The study will access whether breast cancer patients and oncologists can become more hopeful     after participating in a hope enhancement workshop. Several validated tools, Adult Hope     Scale (AHS), Herth Hope Index (HHI), Maslach Burnout Inventory (MBI) and other quality of     life parameter surveys, will be administered at specified intervals.   "
15526|NCT03082248|"     Low back pain is a common symptom, which often affects the adult population. Studies show     that over the past two decades, costs related to spinal surgery have increased significantly,     leading to speculation about what would be motivating this phenomenon. Although expenses with     physical therapy treatments and less invasive surgical procedures remained relatively stable,     the amount spent with more complex spine surgeries increased exponentially until they became     the procedures with the highest costs in healthcare. The criteria for surgical indication are     not uniform among surgeons and therefore a study of second opinion in spine surgeries is     urgently needed. The present study aims to 1) quantify cost-effectiveness of second opinion     for patients with spinal surgery indication 2) evaluate effectiveness of conservative and     surgical treatment for degenerative diseases of the lumbar spine 3) define objective criteria     for indication of conservative and surgical treatment using evidence-based medicine 4)     evaluate prognosis of biological markers in the follow-up of patients with lumbar affections     5) evaluate interobserver agreement of physicians in relation to the diagnoses and treatment     proposals in patients with diseases of the lumbar spine 6) verify effectiveness of patients     who were operated on, compared to patients who were not operated. A prospective cohort study     will be conducted, in which patients with an indication of surgical spinal treatment will be     evaluated for a second opinion. First evaluation diagnoses and indications for patient     treatment will be compared with the second opinion evaluation. All patients who choose to     participate on the study will be followed up for a year for evaluations concerning     cost-effectiveness, pain, quality of life, function and blood biomarkers. The outcomes will     be compared using linear or generalized mixed models and descriptive analyzes of the study     population program will be carried out; Statistical agreement will be observed between the     first and second opinion and also patient acceptance rates for the treatment proposed in the     second indication, evaluating the validity of the project approach. A five-year budget impact     analysis will also be carried out, taking into account the population who was eligible for     treatment according to the admission flow of a private outpatient setting.   "
15527|NCT03082235|"     Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose     study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and     pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants.   "
15528|NCT03082222|"     This is a non interventional prospective study. Centers will enroll adult participants with     partial onset seizures with or without secondary generalisation for whom the clinician has     decided to initiate ESL as an adjunctive therapy prior to the decision to take part in this     study. Participants to be enrolled into the study will receive eslicarbazepine acetate (ESL)     either as an adjunctive therapy to one baseline antiepileptic drug (AED) or to at least two     baseline AEDs. Participants will be seen at baseline and at a follow-up visit after     approximately 6 months to assess retention, efficacy, tolerability, quality of life     (optional), and cognitive performances (optional).   "
15529|NCT03082209|"     This is an open-label, Phase I, dose-escalation study to determine the determine the maximum     tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety,     efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously     treated solid tumors or hematologic malignancies. The study will consist of 2 segments:     Segment I (Dose Escalation) and Segment II (Dose Expansion).   "
15530|NCT03082196|"     The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish.     Single-center, double-blind, controlled Phase 2 study with parallel groups of children.     Subjects will be stratified by early childhood education center and then randomized to     receive either test varnish or control varnish topically to the teeth. Treatment will be     administered quarterly for up to 24 months. The primary outcome is surface-level primary     molar caries increment (d2mfs) at 24- months post baseline.   "
15531|NCT03082183|"     The primary objective of this trial is to investigate the relative bioavailability of a     single dose of BI 425809 when given alone (Reference, B) compared with co-administration     (Test, A) on the 7th day of a 10-day treatment with rifampicin following oral administration     in healthy male volunteers.   "
15534|NCT03082144|"     It has been proved that concurrent radiotherapy (RT) and intrathecal methotrexate (MTX) for     leptomeningeal metastases (LM) from solid tumors with adverse prognostic factors showed great     effectiveness and safety. Cytarabine(Ara-C) is another agent which is commonly used for     intrathecal chemotherapy. The purpose of the study is to observe the effectiveness and safety     of concurrent RT and intrathecal chemotherapy for LM from solid tumors. In addition, the     effectiveness of these two types of agents (MTX and Ara-C) in the concurrent     chemo-radiotherapy will be compared in this study. This is a randomized controlled, parallel     group, and phase II clinical trial. The object of this study is newly diagnosis patients with     leptomeningeal metastases from solid tumors, who will accept the treatment of involved-field     RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Major     endpoint is clinical response rate. Secondary endpoints are time to progression,severe     adverse events and overall survival.   "
15535|NCT03082131|"     The objective of this study is to determine the effect of wheat enriched in resistant starch     (RS) on the generation of fermentation products by the lower gut microbes, the fecal     microbiota profile, intestinal metabolites, and the glycemic response to a test meal compared     to regular wheat.   "
15536|NCT03082118|"     Single arm study of the Vesair Balloon in postmenopausal women.   "
15537|NCT03082105|"     Sufficient oxygenation is critical for completely buried avalanche victims to avoid     life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to     maintain air availability; it was suspected that the snow physical properties affect the     development of hypoxia and hypercapnia. The aim of this study was to evaluate the influence     of different snow physical properties on the development of hypoxia and hypercapnia in     subjects breathing into an artificial air pocket in snow. Twelve male healthy subjects     breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L.     Every subject performed three tests on different days with varying snow characteristics.     Symptoms, gas and cardiovascular parameters were monitored up to 30min. Tests were     interrupted at SpO2 <75% (primary endpoint); or due to subjective symptoms like dyspnea,     dizziness, and headache (i.e. related to hypercapnia). Snow density was assessed via standard     methods and micro-computed tomography (CT) analysis, and permeability and penetration with     the snow micro-penetrometer (SMP).   "
15549|NCT03081949|"     Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and     mortality, and Nigeria probably has the highest burden of the disease in the world.     Unfortunately, much about the disease including its aetiology, epidemiology and treatment is     not yet well described. This will be a prospective, national, multicenter cohort study,     conducted in centres in Nigeria. It is expected that approximately 500 patients with PPCM and     500 apparently healthy pregnant women will be recruited over a 6-month period with follow‐up     at 3-monthly intervals for 18 months.   "
15550|NCT03081936|"     This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk     based formula on alimentation and gastrointestinal digestion. The impact of the study     products on fecal myeloperoxidase (MPO), short-chain fatty acid (SCFA), secretory     immunoglobulin A (sIgA) concentration, gastrointestinal tolerance, defecating habit and     infant growth were also evaluated.   "
15538|NCT03082092|"     Osteoarthritis of the knee is a common and important condition in our society. Despite     various anesthetic methods and pain medications, pain after operation still remains as a     challenge.      Steroids plays a role in decreasing the inflammatory reaction and stress response from     surgery.      This study is to evaluate the use of an additional steroid injection, on top of usual pain     killers and anesthesia, on the effect of pain control and recovery after total knee     replacement.      50 subjects will be recruited, half of them will be randomized to receive a single dose of     steroid injection before operation while the other half will receive a placebo. All the     doctors, patients and physiotherapists are not aware of the allocation. Apart from the     steroid or placebo injection, all the other treatment (eg: surgery, medications,     rehabilitation protocol etc) will be the same. Doctors and physiotherapists will assess the     subjects at 24, 30, 48 hours after surgery and upon discharge for their pain relief and     recovery. Any complications will also be documented.   "
15539|NCT03082079|"     Data are currently insufficient to guide the management of very small gastrointestinal     stromal tumors（GISTs）（< 2 cm) discovered incidentally on endoscopy,this study is designed to     collect the medical records of patients in different treatment group with long-term follow-up     data,and attempts to evaluate the usefulness of regular endoscopic     ultrasound（EUS）surveillance and the necessity,safety and feasibility of endoscopic submucosal     dissection（ESD）for small GISTs,thus provide evidence for the revision of the guideline.   "
15540|NCT03082066|"     Retrospective observational study: Soft tissue and bone diameters are assessed in MRI and CT     scans of patients. Data is compared with recommendations of intraosseus needle producers to     assess whether the information provided by the producers can be optimised. Study sites are     head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended     intraosseus access sites.      Primary and secondary outcome parameters will be assessed at one time only, i.e. when the     patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data     collection for a given patient in this study can be completed within one session, e.g. 5-10     minutes. No additional investigation is required for this retrospective study.   "
15541|NCT03082053|"     The purpose of this study is to explore safety and efficacy of varlitinib administered as     monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered     as combination with capecitabine in Japanese subjects with advanced or metastatic biliary     tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its     metabolite.   "
15542|NCT03082040|"     This is a prospective, triple-blinded and randomized controlled trial examining the effects     of a home-based breathing training assisted with biofeedback on menopausal symptoms and     autonomic functions among community menopausal women. We also examines whether the changes in     autonomic functions would be mediators between slow breathing and menopausal symptoms. This     study will include menopausal women, aged from 45 to 64, who experienced menopausal symptoms.     Participants will be randomly assigned to either an intervention group (n = 80) or a     waiting-list control group (n = 80). The intervention group will undergo the home-based     breathing training 20 minutes twice daily and participants in the control condition will     participate the same breathing training after a four-week waiting list period. The primary     outcome measures are menopausal symptoms measured by symptom diaries of menopausal symptoms     and the Greene Climacteric Scale (GCS). Secondary outcome measures are autonomic functions     expressed by blood pressure (BP), heart rate (HR) and heart rate variability (HRV).     Measurements will be taken at baseline, week 4, and week 8.   "
15543|NCT03082027|"     Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical     importance and added value of superficial ultrasonography in assessment of the median nerve     in CTS.   "
15544|NCT03082014|"     Multicentre, multinational, prospective randomised, open-label, 3 sequence crossover phase     III b clinical trial with blinded endpoint assessment (PROBE-design)        -  in 75 patients with sporadic small vessel diseases (SVDs) and        -  in 30 patients with cerebral autosomal dominant arteriopathy with subcortical infarcts          and leukoencephalopathy (CADASIL)   "
15545|NCT03082001|"     Newborn infants in the neonatal intensive care nursery experience multiple, painful tissue     damaging procedures daily.      Preterm especially extremely low birth weights and critically ill newborns admitted to a     Neonatal Intensive Care Unit (NICU) undergo repeated skin-breaking procedures that are     necessary for their survival. Sucrose is the accepted clinical standard nonpharmacological     intervention for managing acute procedural pain for these infants.      However its role in extremely low birth weight infants still need to be addressed. The exact     dose and concentration of oral sucrose is still not clear.      When a Medline search was carried out to evaluate the role of two different concentrations     (12% vs 24%) of oral sucrose in reducing pain in extremely low birth weight babies, very     limited data was available. Cochrane Systemic Review also indicated that specific attention     to the efficacy and safety of sucrose administration in extremely low birth weight preterm     infants needs to be further investigated. More so, no work on this aspect was identified from     the Indian subcontinent. Hence, the current study was planned with an aim to study the     effects of 12% and 24% oral sucrose in extremely low birth weight infants during initiation     of venipuncture and also study the side effects if any associated with these concentrations.     This is a preliminary work on this topic, the results would therefore need to be interpreted     with caution. However, the findings and the study design of this work will provide suitable     platform for future well powered studies on this population.   "
15546|NCT03081988|"     1. Retrospective review of old patients             -  Analysis of prediction factors for concomitant chemo-radiotherapy in locally               advanced and advanced esophageal cancer from 2005 to 2015        2. Prospective case-control study: RNA sequencing & miRNA microarray             -  naive esophageal cancer patients who have a plan to receive concomitant               chemo-radiotherapy                  -  acquirement of tissue, blood, clinical information                  -  isolation of RNA, DNA, serum database of clinical & demographic information           ***Analysis of mRNA sequencing / miRNA sequencing**** first analysis of RNA sequencing:          bioinformatician second analysis of RNA sequencing: principle investigator        3. Experimental set for qPCR (esophageal tissue) study group        4. TMA for screened exon gene        5. validation set for qPCR (esophageal tissue)        6. follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M)        7. Prediction model for CCRT response in esophageal Cancer based on clinical and molecular          factors        8. Validate the prediction model.   "
15551|NCT03081923|"     Background:      The prognosis of pts who have failed multiple chemotherapy (CT) regimens is quite dismal.     PD-L1 is frequently expressed by immunohistochemistry (IHC) in germ cell tumors (GCT). D is a     monoclonal antibody (mAb) that inhibits the binding of PD-L1. T, an anti-CTLA4 mAb, is an     immunomodulatory therapy. Combination immunotherapy has shown improved activity compared to     monotherapy. The investigators aimed to investigate the activity of D, alone or in     combination with T, in chemorefractory GCT.      Trial Design:      This is an open-label, randomized, 3-stage, phase 2 study. Pts who have failed ≥2 prior CT     regimens (including high-dose CT) will be randomized to receive one of the following: D, 1.5     g via IV infusion q4w, for up to a total of 12 months (13 doses/cycles) alone or with T, 75     mg IV q4w, starting on week 0, for up to 4 months (4 doses/cycles). Serum tumor markers,     computed tomography and fluorodeoxyglucose positron emission tomography (FDG-PET) scans will     be repeated q8 weeks. The primary endpoint is the objective response-rate (ORR=complete     response or partial response with normal markers). H0: ORR rate ≤10%, H1: ORR ≥25%, type I     and II error rates at 10%.      In stage 1, 11 pts will be allocated in each arm. According to Gehan's rule, the trial will     be terminated whenever no response will be observed. 29 additional pts will be added to each     arm fulfilling stage 1 criteria. ORR in ≥7 pts will be required. In stage 3, pts from stage     1-2 of both arms will be retrospectively evaluated for Programmed cell Death Ligand-1(PD-L1)     IHC. The Ventana PD-L1 IHC assay will be used. In case of negative findings at the end of     stage 2, if the target benefit is likely to occur only in PD-L1+ pts, further study     prosecution in accordance with an enrichment strategy will be undertaken.      In particular, predictive power (PP) will be calculated assuming expansion of PD-L1+ cohorts     up to a maximum of 60 pts. Each arm will be categorized as not promising (PP<30%) or     promising (PP ≥30%). The promising one will enter the stage 3. Should both arms be judged     promising, the one yielding ≥20% PP advantage will be selected; monotherapy will be preferred     otherwise. Details on the algorithm to be used for PD-L1 IHC in this study will be finalized     (EudraCT number 2016-001688-35).   "
15552|NCT03081910|"     Patients eligible for this study have a type of blood cancer called T-cell leukemia or     lymphoma (lymph gland cancer).      The body has different ways of fighting infection and disease. No one way seems perfect for     fighting cancers. This research study combines two different ways of fighting disease,     antibodies and T cells, hoping that they will work together. Antibodies are types of proteins     that protect the body from bacterial and other diseases. T cells, also called T lymphocytes,     are special infection-fighting blood cells that can kill other cells including tumor cells.     Both antibodies and T cells have been used to treat patients with cancers; they have shown     promise, but have not been strong enough to cure most patients.      T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the     tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in     the laboratory and then given them back to the person. The antibody used in this study is     called anti-CD5. It first came from mice that have developed immunity to human leukemia. This     antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of     these cells called CD5. CD5 antibodies have been used to treat people with T-cell leukemia     and lymphoma. For this study, anti-CD5 has been changed so that instead of floating free in     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way     it is called a chimeric receptor.      In the laboratory, the investigators have also found that T cells work better if proteins     that stimulate T cells are also added, such as one called CD28. Adding the CD28 makes the     cells grow better and last longer in the body, thus giving the cells a better chance of     killing the leukemia or lymphoma cells.      In this study investigators are going to attach the CD5 chimeric receptor with CD28 added to     it to the patient's T cells. The investigators will then test how long the cells last. These     CD5 chimeric receptor T cells with CD28 are investigational products not approved by the Food     and Drug Administration .   "
15553|NCT03081897|"     In the clinical trial the investigators will observe the impact of regional anesthesia in     addition to a general anesthesia on the expression of substance P in patients with unilateral     Head or Neck cancer undergoing unilateral Neck Dissection. The investigators will perform an     unilateral regional cervical plexus block on the tumor side. The tissue of the tumor side     will be analysed by immunohistology, measuring the expression of the Substance P.   "
15554|NCT03081884|"     This study is for patients who have a high risk of metastatic prostate cancer (cancer that     has spread outside of the prostate) who are going to have radical prostatectomy. The     Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron     emission tomography (PET) scan is a new imaging approach that has promising results in     showing progression of cancer. The goal of this study is to determine if FACBC PET imaging     will detect metastatic disease in patients with high risk prostate cancer who have negative     conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic     resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging     may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary     prostate cancer and potentially improve staging of the cancer. Additionally, the researchers     will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis.     They will also analyze and compare the prostate tissue, serum and urine parameters that are     linked to higher rates of FACBC positivity.   "
15555|NCT03081871|"     Risk factors for cardiovascular disease are poorly controlled even for patients who     frequently visit their physician, leading to large numbers of preventable cardiovascular     events such as heart attacks and strokes. Research from integrated healthcare systems     suggests that risk factors can be controlled better and treatment strategies for     cardiovascular disease can be markedly improved by using a centralized cardiovascular risk     service (CVRS) managed by pharmacists. The investigators are confident that a     pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to     markedly reduce cardiovascular events in the United States.   "
15556|NCT03081858|"     This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade,     noninvasive papillary carcinoma (stage Ta) of the bladder.      Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta     transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of     paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity     (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established).      Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta     (multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest     nontoxic dose (i.e., MTD) established in part 1 of the study.   "
15557|NCT03081845|"     This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed,     cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to     compare the effects on gut inflammation, gastrointestinal symptoms and behavioral well-being.   "
15558|NCT03081832|"     The objective of this study is to collect data on tolerance and effects of early treatment     with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare     these infants with not treated age-matched infants with Prader Willi Syndrome.   "
15559|NCT03081819|"     A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer.      The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one     in six participants, the dose is escalated.      The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than     one in six participants, the dose is escalated.      The third dose group receives SH003 for 3 weeks.   "
15560|NCT03081806|"     This is a Phase 3, Multicenter, 12-Week, double-blind and 40-Week open label Study to     Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of     subjects with Osteoarthritis of the Knee.   "
15561|NCT03081793|"     The aim of the study is to the reliability and feasibility of a novel optical heart rate     monitor in hospital patients. Especially patients with atrial fibrillation are included.     Patients will be monitored for two hours during routine post-operative care. The data from     study device will be compared to routine monitoring. The design of the study is a Pilot     feasibility study.   "
15562|NCT03081780|"     This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a     short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting     chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia     (AML). FATE-NK100 is a natural killer (NK) cell product that is enriched for NK cells with an     adaptive, or human cytomegalovirus (CMV)-induced, phenotype. The NK cell product is     comprised of peripheral blood (PB) leukocytes sourced from a related donor     (HLA-haploidentical or better but not fully HLA-matched) that is seropositive for     cytomegalovirus (CMV+), and enriched for adaptive NK cells by depletion of CD3+     (T-lymphocytes) and CD19+ (B-lymphocytes) cells followed by ex-vivo culture expansion.   "
15563|NCT03081767|"     The investigators wish to determine if standard and digital PET/CT scanners provide     equivalent results for disease detection and diagnosis.   "
15564|NCT03081754|"     When indicated, a conservative management plan of IUGR was undertaken. Doppler studies were     performed within the last week before delivery The results of Umbilical artery (UA) Doppler     velocimetry were categorized as normal , increased , absent, and reversed . Patients were     admitted for close surveillance in the case of worsening of maternal or fetal conditions     (e.g. absent or reversed UA blood flow, and severe preeclampsia).      Tissue samples The general shapes of placentas were assessed. The collected placentas were     weighed by trimming the membranes and umbilical cord. Then the diameters and thickness of     placentas were noted. The position of insertion of umbilical cord on the fetal surface of     placenta was observed. Transverse cuts were made through the maternal surface at a distance     of 1-2 cm in bread loaf manner and examined for the pale areas. All placentas were immersed     in 10% formalin overnight and examined on the next day. For each placenta, blocks containing     cord, membrane and full thickness of villous tissue were prepared. Whole thickness villous     tissue blocks were obtained from three zones, i)central zone ii) peripheral zone and iii)     intermediate zone between the first two zones, so as to include all areas of placenta.      Placental bed biopsies were obtained at Caesarean sections with direct visualization of the     placental site. Biopsies of at least 1cm were taken. The specimens were fixed in buffered     formalin. The tissues were processed and stained with Haematoxlyin and Eosin. Microscopic     study of placenta was carried out utilizing a set of standard criteria for villous and     intervillous lesions      Immunohistochemistry Expression of VEGF and CD34 was analyzed in 75 (50 placenta of IUGR and     25 of control) placental villous tissues.      Immunostaining was performed by the streptavidin-biotin-peroxidase method. Evaluation of     immunohistochemical staining To determine the MVD, the stained placental vasculature. Tissue     sections were initially screened microscopically at low power (100×) to identify the areas of     highest vascularization (hot spots).      Evaluation of immunohistochemical staining of VEGF:   "
15565|NCT03081741|"     Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.   "
15569|NCT03081689|"     Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and     efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W     + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult     patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months     and Nivolumab 480mg Q4W for 8 months.   "
15570|NCT03081676|"     The most prevalent monogenetic diabetic subtype is named maturity onset diabetes of the young     type (MODY3) or hepatocyte nuclear factor 1α (HNF1A)-diabetes. The aim of this study is to     evaluate the effects of supra-physiological levels of GIP and GLP-1, respectively, on insulin     and glucagon secretion at fasting plasma glucose (FPG) and post-prandial PG levels (1.5 ×     FPG) in patients with HNF1A-diabetes and matched healthy controls treated with or without a     low dose of glimepiride (sulphonylurea). In addition, we will evaluate the maximal insulin     and glucagon secretory capacity in both groups.   "
15571|NCT03081663|"     This study is a randomized clinical trial comparing standard medial para-patellar total knee     arthroplasty with a quadriceps sparing mid-vastus approach. Patients who are medically well     and have a good support structure at home will be randomized to a standard or quadriceps     sparing surgical approach stratified by type of analgesia (adductor canal block or local     infiltration). We will compare patient satisfaction and costs from the perspective of the     Ministry of Health, the institution, society and the patient.   "
15572|NCT03081650|"     The primary purpose of this study is to show whether at home usage of the AIRVO warm     humidifier can potentially reduce the number of exacerbations in patients with significant     respiratory insufficiency. Eligible participants of the study must have a diagnosis of     chronic obstructive pulmonary disease (COPD) stage II-IV..   "
15573|NCT03081637|"     The risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high.     Having a predictive marker of early recurrence (ER) would be desirable to personalize the     follow-up and possibly develop new targeted therapy. The aim of this study was to test the     expression of Filamin A (FLNA) in a cohort of patients operated for HCC.   "
15574|NCT03081624|"     Beginning school is an important milestone for children. Children's readiness for school     involves cognitive, physical, and emotional development. While the majority of children born     preterm are able to transition from preschool to kindergarten with little difficulty, some     children experience challenges during this time. Factors that negatively influence children's     success in kindergarten include their age, socioeconomic status, neurological status and     their ability to interpret sensory information from their environment.      This study was planned to explain the relationship between the primary school readiness and     the neurological status of preterm born children.   "
15575|NCT03081611|"     Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive     Positive Pressure Ventilation (NIPPV) for preterm infants   "
15576|NCT03081598|"     This is a Phase 2, multi-center, double-blind, placebo-controlled study of the safety and     effect of PBI-4050 at doses ranging from 400 mg to 1200 mg on relevant biomarkers in subjects     with inadequately-controlled T2DMS on stable background antidiabetic therapy.   "
15577|NCT03081585|"     The aim of this study is to investigate the influence of different metabolic states and     hormonal satiety signalling on responses in neural reward networks.   "
15598|NCT03081299|"     This is a prospective descriptive correlational design looking to characterize postoperative     pain variables across various procedures that historically have significant levels of     persistent post-surgical pain   "
15599|NCT03081286|"     This study evaluates the possible beneficial effect of fat grafting for post mastectomy pain     syndrome. Half of patients will receive fat grafting and the other half of patients will     receive sham.   "
15578|NCT03081572|"     This is a small observational study aimed at observing differences in platelet function in     HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation     between platelet activation and cardiovascular disease- this study will act as a pilot to see     if platelet activation among abacavir users may explain the correlation between abacavir and     cardiovascular disease in HIV positive patients.      This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on     tenofovir-based treatment. There is only one study visit which includes a blood draw,     physical assessment, and review of medical history.   "
15579|NCT03081559|"     Transgender women (assigned 'male' at birth but who do not identify as male) are     disproportionately impacted by HIV and have culturally unique barriers and facilitators to     engagement in HIV care. Transgender women living with HIV (TWH) are less likely than others     to take antiretroviral therapy (ART), and those who initiate ART have lower rates of ART     adherence, lower self-efficacy for integrating ART into daily routines, and report fewer     positive interactions with health care providers than non-transgender adults. As a result,     TWH have an almost three-fold higher viral load than non-transgender adults in San Francisco;     in Los Angeles, TWH are less likely to be virally suppressed than any other behavioral risk     group. In formative work, the investigators have identified culturally-specific and     modifiable barriers to HIV treatment engagement among TWH, including prioritization of     transition-related health care (i.e. hormone therapy) at the expense of HIV treatment,     avoidance of HIV care settings due to past negative health care experiences, misinformation     about ART including potential drug interactions with hormones, intensified HIV stigma, low     levels of social support, and poor coping skills. There are both individual and public health     consequences to poor engagement in care among TWH stemming from high transmission risk     factors, including substance abuse, high numbers of sex partners, engagement in sex work, and     high rates of mental illness. These findings strongly suggest that TWH face unique challenges     to engaging in and adhering to HIV treatment, and that the public health consequences for     poor engagement in this population are of grave concern. Interventions to mitigate these     barriers to engagement in care are critical in efforts to alter the pattern of HIV-related     disparities that lead to disproportionately poor health outcomes for this highly vulnerable     and marginalized population. The investigators are conducting a randomized controlled trial     of a theory-driven, population-specific, piloted intervention to improve engagement in care     for TWH. Grounded in the investigators' Models of Gender Affirmation and Health Care     Empowerment, the proposed research is the first to systematically intervene on complex     barriers to optimal engagement in HIV care for TWH. The investigators have developed and     piloted the Healthy Divas intervention to optimize engagement in HIV care for TWH at elevated     risk for treatment failure and consequential morbidity, mortality, and transmission of HIV.   "
15580|NCT03081546|"     This study plans to assess the effectiveness of performance-based functional assessments     (PBFAs) and cognitive assessments in diagnosing Alzheimer's disease in Hispanic/Latino     populations. The information from this study will be analyzed with data from the Rocky     Mountain Alzheimer's Disease Center Bio-AD study (NCT02612376).   "
15589|NCT03081429|"     With the development of population aging, the incidence of covert stroke and cognitive     dysfunction gradually increased. Currently, there is still lack of prospective cohort study     with large sample size on the relationship between perioperative covert stroke and     postoperative cognitive dysfunction. The investigators will perform a prospective cohort     study. The aim of the study is to determine whether there is an association between     perioperative covert stroke and postoperative cognitive dysfunction in elderly patients     undergoing noncardiac surgery.   "
15590|NCT03081416|"     This is a randomized, single-blind, placebo controlled trial to evaluate the efficacy of     sub-dissociative dose ketamine versus standard care therapy for acute headache management of     in patients presenting to the emergency department with headache as the chief compliant.   "
15581|NCT03081533|"     The task of caring for an individual with Alzheimer's disease is often carried out by elderly     caregivers who, due to their motor and psychosocial alterations due to the aging process, may     also be exposed to the development of the frailty syndrome. Therefore, it is necessary to     promote the engagement and adherence of these caregivers in physical activities. In this     sense, circle dances have received attention, either as a modality of physical activity or     therapy, and, although little studied, seem to be an appropriate type of intervention for the     elderly caregivers. Thus, this study aims to evaluate the effect of 12 weeks of circle dances     on cognitive, psychological, physical and frailty-related variables in elderly caregivers of     Alzheimer's patients. It is expected that the practice of circle dances will be able to     reduce stress levels and depressive symptoms of elderly caregivers; Reduce and / or maintain     the perception of care overload and improve some functional components such as: mobility;     balance; muscle strength of legs; walking speed; fatigue and level of physical activity.   "
15582|NCT03081520|"     The aim of this study is to examine acute affective responses during and after a series of     exercise sessions with different intensities in young healthy adults. The study is a     randomized controlled trial with three different groups (A: moderate continuous training     (MIT), B: high-intensity aerobe interval training (HAIT), C: high-intensity sprint interval     training (HIIT)). Healthy adults aged 18-40 years (n=30) will be invited to participate. Each     participant will perform a VO2max test followed by five session of the randomized type of     training. The sessions will be completed within two weeks. The participants will complete     questionnaires regarding exercise motivation (Behavioral Regulation of Exercise     Questionnaire), mood (Positive and Negative Affect Scale, Profile of Mood States, Visual     Analogue scale, Self-assessment Manikin Rating Scale) and perceived exhaustion (Borg Ratings     of Perceived Exertion scale). In addition, blood lactate and heart rate will be obtained     during and after each session.   "
15583|NCT03081507|"     Studies have reported Muslims in the US and NYC face numerous language and healthcare access     barriers. This is a randomized randomized controlled design will be used to test the efficacy     of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical     cancer screening among Muslim women age 40 - 75 years living in NYC. Study participants will     be randomized to an Lay Health Workers (LHW) led small media intervention arm (SM-LHW) or a     LHW-led patient navigation plus small media intervention arm (PN-LHW). A specific aim of the     study is to develop, implement and evaluate the efficacy of a two-arm, randomized control     trial designed to increase receipt of breast and/or cervical cancer screening among Muslim     women aged 40 -75 years in New York City (NYC).   "
15584|NCT03081494|"     This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with     previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will     assess primarily the safety and tolerability and then the efficacy of PDR001 in combination     with regorafenib. Particular attention will be paid to the level of activity of study drug     combinations in CMS4 patients (retrospective analysis).   "
15585|NCT03081481|"     The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for     the treatment of low to intermediate risk prostate cancer.   "
15586|NCT03081468|"     In current, clinical ophthalmology, a range of specialised testing allows comprehensive     evaluation of ocular health. These tests have typically evolved over many years to ensure     their clinical validity. For example, the assessment of visual acuity has traditionally been     measured with Snellen letter charts from a distance of six metres (20 feet), leading to the     phrase 20/20 vision. Despite this, the limitations of Snellen testing are well established     and more sophisticated testing is now available (e.g., logMAR testing using ETDRS (Early     Treatment Diabetic Retinopathy Study) charts). Many other diagnostic tests have undergone     similar cycles of refinement, often over extended time periods. Therefore, it should be     incumbent on any new device to undergo detailed evaluation of its validity (how its     measurements agree with other testing) and its repeatability (the variability when a further     measurement is obtained in short time period, by the same operator and under the same     conditions).      Binocular OCT extends the application of OCT devices beyond that of simple, cross- sectional     imaging to a diverse array of diagnostic tests. The binocular design also removes the need     for additional personnel to perform testing (i.e., the device can be self-operated in an     automated manner), and allows for novel testing to be performed that is not possible with     monocular imaging. In particular, binocular OCT devices have the potential to perform     automated, quantitative pupillary measurements - an entirely novel application for this     imaging modality.      This study will assess the validity and repeatability of pupil measurements using binocular     OCT.   "
15587|NCT03081455|"     A prospective, non-interventional study to evaluate the impact of a process engineering     intervention on screening and testing outcomes for common hereditary cancer syndromes in     community-based OB/GYN settings.   "
15588|NCT03081442|"     Groups of study:      120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into     two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as     possible six hours before IUD insertion.      Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in     120 numbered closed envelopes according to the table of random numbers and an envelope was     allocated to each patient accordingly.      Methodology:      All patients were subjected to the following:      (i) Complete history taking (ii) Proper counseling: (iv) Examination: (v) 600ug misoprostol     (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo were administered     Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist .      (vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken     , Proper counseling, Informed consent is taken from each patients, examination ( general ,     abdominal and pelvic )to exclude any pathology .      A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by     introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone-     iodine solution.      The Next step was to sound and measure the depth of the uterus. The IUD was folded into the     insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and     gently pulled downward to straighten the angle of flection.      The insertion tube was advanced into the uterus to the correct depth as marked on the tube by     a sliding plastic flange.      The outer sheath of the insert was withdrawn a short distance to release the arms of the T     and was then gently pushed inward again to elevate the opened T against the fundus of uterus     .      The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the     external cervical os.   "
15760|NCT03079193|"     Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and     near total thyroidectomy some unilateral injuries are not clinically evident and     asymptomatic.      The aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic     examination of larynx to detect laryngeal nerve injuries.   "
15591|NCT03081403|"     Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have     sensitive skin.      The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients     stimuli of different modalities to measure a subjective somatosensory response. This allows     to characterize sensory dysfunction by assessing the participation of small and large nerve     fibers.      The aim of this project is to characterize the presence or absence of a neurological disorder     in patients with sensitive skin. This discovery would be a decisive argument to reinforce the     suspicion that sensitive skins is linked to a small fiber neuropathy.   "
15592|NCT03081390|"     The primary goal of this study is to test the effects of a high-fat, high-carbohydrate mixed     meal on candidate modulators of cardiovascular disease risk (inflammation, vascular     reactivity, sympathetic nervous system tone, and response to pain) in young adult women with     migraine compared with healthy young women. This is study enrolling both cases (women with     migraine) and controls (women without migraine), with equal numbers of normal weight and     obese women in each group. Participants will undergo a telephone screening and a single day     in-person study visit.   "
15593|NCT03081364|"     The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac     Implanted Electronic Devices)   "
15594|NCT03081351|"     This clinical trial is about the survival benefit of extended lymphadenectomy and nerve     clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic     adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.   "
15595|NCT03081338|"     Amyotrophic Lateral Sclerosis (ALS) or else known as Motor Neurone Disease (MND) is a rapidly     progressive fatal neurological disease that strikes in the prime of life, and for which there     is no treatment. The principal aim of management is to maintain quality of life and reduce     the symptoms of the disease. This requires a multidisciplinary approach using best practice     for symptom alleviation, including innovation approaches towards maximising quality of life.     The purpose of this study is to use existing information drawn from partner countries into a     system of care that is available to people with amyotrophic lateral sclerosis at the correct     time, in the correct format and in a cost effective manner. This will be achieved by     collecting details of patient and carer experiences across all stages of from diagnosis to     end of life, including decision making in the terminal stages of the disease. A health     economic analysis will help to identify the overall costs of disease management, provide     models of increased efficiency that preserve and maximize quality of life, and begin to     develop novel health economic measurement tools for terminal neurological illness. The     completed project will provide a user-friendly best practice programme for amyotrophic     lateral sclerosis that can be modified for management of other related degenerative diseases     of the nervous system.   "
15597|NCT03081312|"     This research will determine (a) the unmet needs of family caregivers of adult cancer     patients and (b) determine the impact on stress, care burden and quality of life.      A cross-sectional questionnaire methodology will be used to answer the research questions.     510 family caregivers at different stages of patients' cancer journey will be recruited. The     study duration is expected to take two years. Research findings will address the knowledge     gap of caregivers' needs and stress, burden and quality of life and support plans to help     caregivers.   "
15600|NCT03081273|"     Corynebacterium spp have been considered as innocuous commensals of human skin, but are now     accepted as important opportunistic pathogens responsible for various nosocomial infections,     especially implicating foreign materials. In particular, they accounted for up to 10% of     prosthetic joint infection (PJI), and are mostly identified in chronic forms of bone and     joint infections (BJI). However, little is known about the pathophysiological pathway     implicated in Corynebacterium BJI, species distribution and antimicrobial susceptibility, and     the management of these difficult-to-treat clinical entities.      This study aims to report a retrospective cohort of patients with Corynebacterium spp BJI,     aiming to : i) describe microbiological characteristics of the implicated clinical isolates,     including species identification and antimicrobial susceptibility (and especially according     to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with     BJI chronicity, including biofilm formation and bone cell invasion, to better understand     mechanisms of Corynebacterium spp and to evaluate their ability to distinguished colonizing     and infective isolates; iii) describe the medical (nature and duration of antimicrobial     therapy) and surgical management of these patients; and iv) evaluate the patient outcome     according to this management strategy, and highlight risk factor for treatment failure in     order to improve patient's management.   "
15648|NCT03080649|"     The aim of this study was to evaluate the excavation time, patients´ experiences, pulpal     reactions and survival of fillings when carious tissue was removed with Er:YAG laser compared     to rotary bur. A prospective, single-blind, randomized and controlled investigation was     performed. Patients with at least two primary caries lesions radiographically assessed as the     same size were recruited. In each patient one cavity was excavated with rotary bur and one     with Er:YAG laser technique. The time requested for excavation and local anaesthesia were     measured. The prevalence of postoperative symptoms, pulpal vitality and the quality of     fillings will be investigated during two years after the excavation occasion.   "
46098|NCT02682238|"     To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle     (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.   "
15601|NCT03081260|"     Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000     interventions per year. The total knee prosthesis is also called tri-compartmental because it     allows articulation between the femur and the tibia but also between the femur and the     patella.      The patella belongs to the extensor system. It articulates with the femoral trochlea in which     it slides. It has an important biomechanical role on the quadriceps strength in addition to     allowing flexion-extension movements.      In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene     implant is sealed with cement using studs on the same face.      In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which     will be in direct contact with the femoral prosthetic trochlea.      Both methods have advantages and disadvantages. For some implants, it is recommended to     resurface the patella because the implant is not very tolerant with the native patella. Other     implants have been designed to be better adapted to the preservation of patellar cartilage.      There is currently no evidence that one method is superior to the other on new generation     implants known as patellar friendly.      It seems necessary to compare both methods in terms of long-term postsurgery results.   "
15602|NCT03081247|"     This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared     to BFF MDI in subjects with moderate to very severe COPD.   "
15603|NCT03081234|"     This is an international, multi-center, randomized, double-blinded, placebo-controlled     clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an     adjuvant treatment in patients with hormone receptor-positive, HER2-negative, intermediate     risk breast cancer.   "
15604|NCT03081221|"     The purpose of this study is to verification of Endotracheal Tube Placement with     Ultrasonography (USG).   "
15605|NCT03081208|"     The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of     nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer     (ET) day.   "
15606|NCT03081195|"     The objective of this research study is to examine the implementation of and outcomes     associated with an evidence-based practice (EBP), specifically Multiple Family Group (MFG)     targeting youth disruptive behavior challenges and success, through a scale up intervention     study in Uganda, and two pilot studies that will be conducted in Kenya and Ghana   "
15607|NCT03081182|"     The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible     for the coordination and data management for the Pediatric Longitudinal Cohort Study of     Chronic Pancreatitis (INSPPIRE 2), which is part of the NIH U01 funded Consortium for the     Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). All patient     recruitment will occur at external sites that are a part of the CPDPC. The data management     systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center     Clinical Research Support Center (CRSC).   "
15608|NCT03081169|"     This study compares the efficacy and complication rates of early (24 hours) versus late (72     hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will     be monitored for development of VTE as well as complications from bleeding after commencement     of VTE prophylaxis.   "
15609|NCT03081156|"     This trial is an investigator initiated study involving the use of the AstraZenica Aerophere     Inhaler (Glycopyrrolate/Formeterol) to determine the effect on exercise tolerance and dynamic     hyperinflation in patients with chronic obstructive lung disease.   "
15610|NCT03081143|"     This clinical trial will evaluate whether it is beneficial in terms of prolongation of     survival to combine FOLFIRI (standard treatment) with ramucirumab compared to the standard     treatment of ramucirumab plus paclitaxel in patients with advanced gastric cancer after     failure of one prior line of palliative chemotherapy. This trial aims to investigate the     efficacy and safety of ramucirumab plus FOLFIRI (investigational arm A) compared to     paclitaxel plus ramucirumab (control arm B).   "
15629|NCT03080896|"     Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope     (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in     patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx     To test the hypothesis that combination of video-laryngoscope with the fiber-optic     bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral     cavity, pharyngeal or laryngeal pathologies undergoing surgery   "
15611|NCT03081130|"     We will recruit 30 poor ovarian responders and thin endometrium patients, aged 35-45 year     old, and treat with intravascular laser irradiation of blood (ILIB) via an intravenous     catheter for irradiation of the blood under a period of 60 minutes for 10 days. We will     evaluate the number and the quality of oocyte retrieved, endometrium thickness and pregnancy     rate. The goal of the study is to evaluate whether ILIB is the efficient treatment to improve     the ovarian response and the clinical outcome of the poor ovarian responders and thin     endometrium patients.   "
15612|NCT03081117|"     Infection with HIV (the virus that causes AIDS) can lead to problems with brain function,     such as memory, concentration, judgment, and the speed or control of hands and legs.     Neurologists have called this condition HIV-associated neurocognitive disorder (HAND). This     research is being done to see if insulin taken through the nose as a spray (intranasal     insulin) can help people with HIV who are having problems with memory and brain function, or     HAND.      Participants will be given either insulin or placebo. A placebo is an inactive substance that     looks like the study drug, but does not contain study drug. For this research study, the     placebo will be a clear, saline-based liquid spray that looks like the insulin spray but has     no insulin. Participants will not be told whether they receive insulin or placebo during the     study.      All participants will take the intranasal spray twice a day, about 30 minutes after a meal.     Participants will use a specialized intranasal drug administration device. The total daily     dose of insulin is 40 IU split between 20 IU in the morning and 20 IU in the evening.     Participants will take the intranasal spray for 24 weeks.      The researchers will record symptoms and side effects during the study. Procedures include     neurocognitive testing of memory and brain function, two lumbar punctures (spinal taps),     two MRI brain scans, several blood draws, and clinical assessments.   "
15649|NCT03080636|"     The present study compared the acute effects of Sex and exercise mode on subsequent blood     pressure (BP) and heart rate variability (HRV) responses during daily work in healthy adults.     All subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym     and a seated control session.   "
15650|NCT03080623|"     This study proposed to construct an ultrasound-based diagnostic model for Differentiating     Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and     prospective part, which are designed for model construction and independent validation,     respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the     efficacy of the model for identifying malignant breast lesion from benign lesion, and finally     promote the application of this diagnostic model in more clinics.   "
15613|NCT03081104|"     The intervention to be evaluated are operative hysteroscopy(group A) and ultrasound guided     aspiration(group C) and blinded vacuum aspiration(group B).      For all surgical procedures , surgical antibiotics prophylaxis, misoprostol to dilate cervix,     and anti adhesion barrier gel will be used. The evacuated retention products will be sent for     pathological examination.      Group A: Operative Hystroscopy:      The procedure will be performed under general anaesthesia with the patient in lithotomy     position. the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate     insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine,     with a maximum irrigation pressure of 110mmHg. The retained products will be resected from     top to bottom with surgical resector without electric power. The use of forceps or curettes     to facilitate the removal of material is permitted. .      Group B:blinded vacuum aspiration of gestational contents:      The women were allowed to empty their urinary bladder before induction of anesthesia, After     positioning the patient appropriately on the operating table, bimanual pelvic examination was     performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum     was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum     forceps. The cervical canal was dilated gradually with Hegar dilators up to the size     corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic     cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The     aspirate was examined to confirm the presence of products of conception. The completeness of     the evacuation was checked by gentle sharp curettage and final suctioning at the end of     procedure.      Group C: Ultrasound guided aspiration curettage :      same as group B but guided with ultrasound   "
15614|NCT03081091|"     Background: Chronic Widespread Pain (CWP) is a multidimensional disorder for which treatment     as yet remains unsatisfactory. Acupuncture is one of the most sought therapeutic methods when     it comes to alternative medicine, due to its minimal adverse effects and its ease of use in     clinical practice. Currently, acupuncture is successfully used in China for the treatment of     many chronic diseases. The work to be carried out aims to assess the effects of acupuncture     on pain management and quality of life of people suffering from CWP.      Methods/design: The study is a single-center, controlled triple-blind prospective study. A     total of 100 participants will be randomly distributed into two groups, the intervention     group, which will receive an individualized acupuncture treatment; and control group, which     will receive sham acupuncture. The treatments performed will be personalized and the     treatment criteria will be based on the use of the Yuan and Luo points. They will be     evaluated using a specific measurement system, constituted of the Visual Analogue Scale, The     Fibromyalgia Impact Questionnaire and The Medical Outcomes Study Sleep Scale. The primary     outcome measures assess whether acupuncture can bring about a decrease in pain and an     improvement in the quality of life of people suffering from chronic widespread pain; the     secondary outcomes assess whether the use of acupuncture leads to improved sleep quality. The     results obtained will be analysed at 1st, 4th and 8th weeks from the start of treatment.      Discussion: This technique is aimed to restore some of the imbalances suffered by patients     affected with CWP and to improve their symptomatology. We expect to observe a significant     improvement in the pain, quality of life and sleep quality of people affected with CWP. The     study will be conducted according to the STRICTA guidelines, which lay down the right way to     proceed when carrying out scientific studies in the field of acupuncture.   "
15615|NCT03081078|"     The study will determine whether community-based caring contact via a mobile app connection     with or without volunteer support in addition to treatment as usual (psychiatric and     psychosocial treatments) has an effect on suicidal ideation and treatment compliance among     post-discharge self-harm young adults.   "
15630|NCT03080883|"     This randomized phase III trial studies the best dose of apixaban and how well it works in     preventing secondary cancer related blood clots in cancer patients who have completed     anticoagulation therapy. Apixaban may stop the clotting of blood by blocking some of the     enzymes needed for blood clotting.   "
15631|NCT03080870|"     Music, dance and visual arts are suggested to support health and well-being of older people.     Intervention studies, however, are scarce. JOY of ART study investigates the effects of     multicomponent art intervention among older people and ther family caregivers.   "
15632|NCT03080857|"     This will be a before-after study, using a prospective cohort to evaluate the use of a     virtual, patient-centered platform as compared to a historical cohort of patients with atrial     fibrillation (AF) and if the education and support provided by the platform will reduce     Emergency Department visits for AF.   "
15633|NCT03080844|"     The purpose of this research study is to help determine whether practicing resisting the urge     to smoke changes brain function or behavior among smokers.   "
16156|NCT03074019|"     The purpose of this clinical trial is to assess the efficacy of a novel prebiotic, XOS95, at     two different dosages, in comparison to a placebo by assessing shifts in microbial     populations after 8 weeks of supplementation, assessed as changes in abundance of microbial     populations.   "
15616|NCT03081065|"     OBJECTIVES:To assess the effect of the intervention with Mediterranean Diet (MD) supplemented     with extra virgin olive oil (EVOO) or tree nuts (TN) during 2 years (compared to a control     group without intervention) on the risk of recurrence of unipolar depressive disorder in     patients with partial or total remission for unipolar depressive disorder (1). Differences     between groups in changes in residual symptoms (2), quality of life (QL) (3), biochemical     parameters (4) and in the risk of medical/psychiatric co-morbidities (5) will be also     analyzed. Finally, gut microbiota and its changes will be collected and compared between     groups (6). METHODS: Multicenter clinical trial with 3 arms of intervention (MD+EVOO;     MD+TN;control) during 2 years. Adults with previous episodes of unipolar depressive disorder     in partial or total remission stage (determined through Montgomery-Asberg questionnaire and     MINI interview) will be included. Participants with current depression, psychiatric co-morbid     disorders or with problems to follow dietary recommendations will be excluded. A recurrence     ratio of 35% in the MD groups and of 50% in the control group will be considered (Hazard     Ratio: 0.7). We estimate a sample size of 720 participants (750 to count for losses) (90%     power and 5% alpha error). Intervention will be performed through postal mail (recipes and     information), email, phone y new technologies (Web page/mobile app) with periodic contacts     with psychiatrics and dieticians and postal mail for free EVOO and nuts supply. Information     from participants will be gathered with validated questionnaires of diet, physical activity,     QL, or symptoms using postal mail, email, Web page or the phone. The analyses will be     performed by intention to treat.   "
15617|NCT03081052|"     The primary purposes of this study has 2 aims. First, to conduct a clinical investigation to     determine if iEPO, Veletri® will have similar efficacy in pulmonary vasodilation and have a     similar impact when compared to iNO, INOMAX® in adult patient who undergo a heart     transplantation, lung transplantation or implantation of a left ventricular assist device .     Second, to conduct a cost-capture analysis on the expense each drug incurs per patient.   "
15618|NCT03081039|"     Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine     versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.   "
15619|NCT03081026|"     To assess the risk of lower extremity angular growth deformity following anterior cruciate     ligament (ACL) reconstructions in young patients who are not yet skeletally mature. The study     will compare two surgical techniques (physeal sparing vs transphyseal).   "
15620|NCT03081013|"     The study aims:        1. To test the effect of providing social comparison information on increasing physical          activity among Singaporean adolescents.        2. To test whether providing social comparison information increases physical activity more          when it is provided publicly compared to when it is provided anonymously.   "
15621|NCT03081000|"     Aims:-      Primary:      To identify the incidence of intra-operative and post-operative hypothermia      Secondary:      To identify factors contributing to peri-operative hypothermia. To identify current     anaesthetic practice in peri-operative temperature monitoring, use of active/warming measures     by anaesthetists in various hospitals.      To increase awareness of the problem of IPH and guidelines available.   "
15622|NCT03080987|"     The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in     Part 1 and 2.   "
15623|NCT03080974|"     Compare the efficacy and tolerability of irreversible electroporation in combination with     Nivolumab in patients with locally advanced pancreatic cancer.   "
15651|NCT03080610|"     Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have     some adverse events such as high spinal block, nerve injuries or postdural puncture headache     (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice.      The investigators are curious regarding factors determining the incidence of postdural     puncture headache in parturients undergoing cesarean section after epidural blood patch.   "
15624|NCT03080961|"     Genital herpes has a high prevalence in industrialized as well as developing countries.      Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be     transmitted mother to child during birth with possible serious consequences.      Medical treatments and condoms only partially reduce the risk for transmission from/ to     sexual partners. Genital herpes transmission despite use of condoms is thought to be due to     transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be     enhanced by current shaving habits in the genital area leading to micro lesions (lacerations)     of the skin.      VIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin.     Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over     80%.      The objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults     with HSV-2 infection by comparing virus detection in the extra-genital area before and after     application of the barrier cream.   "
15625|NCT03080948|"     The investigators are doing this study to improve our ability to identify which people with     many moles on their skin are most likely to develop skin melanoma. The investigators hope to     identify features of moles that are associated with melanoma risk. The investigators hope to     use this information to customize and tailor melanoma screening to the individual patient     based on a better estimate of their individual risk.   "
15626|NCT03080935|"     This is a multicenter, open-label extension (OLE) study designed to assess the extended     long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study     20110118). Approximately 1600 subjects will be enrolled in this study. This study will     continue for 260 weeks (approximately 5 years).   "
15627|NCT03080922|"     The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic     mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with     relapsed/refractory acute myeloid leukemia（AML）.   "
15628|NCT03080909|"     A double-blind, randomized crossover design with five arms including four experimental     conditions and placebo will be applied. After having successfully completed screening     procedures, eligible participants will be invited to five separate test days. The test days     cannot be within the same week, however there is no upper limit for days in between, as long     as the participants remain weight stable and do not change diet or physical activity level.     Significant changes in diet, physical activity level (evaluated by the sub-investigator) or     weight change ±3 kg over the course of the study (from screening to completion of the last     test day) results in exclusion of that subject.   "
15634|NCT03080831|"     Prospective randomized double blind phase IV trial studying the efficacy and safety of the     tonicity of two different perioperative maintenance solutions: an isotonic solution     containing NaCl 0.9 in glucose 5% with an added 40 mmol/L of potassium or a commercially     available premixed solution (Glucion 5%) containing a.o. 54 mmol/L of sodium and 26 mmol/L of     potassium. Both solutions are administered at 27 mL/kg of ideal body weight, as recommended     by current guidelines (NICE 174) and both solutions are widely used in daily clinical     practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid     retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential     analysis of urine and serum and clinical parameters.   "
15635|NCT03080818|"     This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG     improves psychological status in middle age and older adults through a 12-week, randomized,     double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to     examine the possible benefits of probiotic supplementation on cognitive function and markers     of physical health.   "
15636|NCT03080805|"     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This     study is a randomized,open-label,multi-center,active-controlled, parallel design study of the     combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC     patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1     ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) +     capecitabine (1000 mg/m^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine     (1000 mg/m^2 twice daily).Patients will receive either arm of therapy until disease     progression, unacceptable toxicity, or withdrawalof consent.   "
15637|NCT03080792|"     The PRESENT-P study is a one-arm exercise intervention study for hematological cancer     patients prior allogeneic stem cell transplantation (allo-HCT). This pilot study will     investigate in a prehabilitation approach the safety and feasibility of high-intensity     exercise program directly prior transplantation.   "
15652|NCT03080597|"     The investigators' overall goals are to target (a) pre-exposure prophylaxis (PrEP) uptake by     addressing access and acceptability and (b) PrEP adherence among Historically Black Colleges     and Universities (HBCU) students.   "
15638|NCT03080779|"     Post Dural Puncture Headache (PDPH) causes significant short-term disability, prevents     mobilisation, affects childcare activities and results in prolonged hospital stay. Initial     treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch     (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is     generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However     there is emerging evidence that patients with PDPH could be at an increased risk of     developing longstanding (chronic) headaches. Retrospective case studies show that between 28     - 34% of patients who developed PDPH had longstanding headaches at 18 months after the     insertion of the epidural. There is also recent evidence of new onset low back pain     developing in patients who have received an epidural blood patch that was performed to treat     PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after     they had received epidural blood patch treatment. Presently, there is no prospective clinical     study evaluating the development of longstanding headaches and new onset low back pain after     the development of PDPH. Aim of the present study is to evaluate the incidence of     longstanding headache after accidental dural (ADP) puncture and the incidence of new onset     low back pain after epidural blood patch treatment.   "
15639|NCT03080766|"     Acute myeloid leukemia (AML) is a heterogeneous group of diseases with distinct     clinicopathologic features sharing in common an abnormal increase in myeloblasts in blood and     bone marrow (BM). In about 5-10% patients, the myeloblasts exhibit chromosomal abnormalities     (complex and/or monosomal karyotype, CK/MK*) that are associated with refractoriness to     conventional chemotherapy and an extremely bad prognosis.      Standard induction chemotherapy for AML comprises daunorubicin and cytarabine, the 7+3     regimen. However, treatment is largely ineffective for CK/MK AML with a temporary clearance     of blasts achieved in only 30-40% cases and the cumulative toxicities resulting from repeated     courses of chemotherapy have significantly increased the morbidity and mortality risks in     subsequent allogeneic BMT. Therefore, standard treatment is unsatisfactory and there is an     unmet clinical need for more effective and less toxic induction regimen.      Both previous and recent studies showed that 10 day course of decitabine (20 mg/m2/day)     induced remission in 70-100% patients with CK/MK AML, particularly those with TP53 mutations.     In this study, patients with CK/MK AML will be treated with decitabine to induce remission.     Bone marrow examination will be performed after each course until complete clearance of     blasts or disease progression. Patients achieving CR/CRi (see below) will continue to receive     4 more courses, after which patients eligible for BMT and for whom donors are available will     receive curative BMT. We reckon that the time it takes for 4 courses of decitabine will     suffice for transplantation workup in HK. . Patients ineligible for BMT will continue to     receive decitabine until leukemia progression. The response rate, leukemia free survival     (LFS), overall survival (OS) and percentage of patients who can be bridged to BMT will be     compared with historical 7+3 regimen control.   "
15640|NCT03080753|"     The purpose of this study is to determine whether treatment with intersphincteric implants is     an effective and safe treatment option for patients with anal incontinence   "
15641|NCT03080740|"     Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to     assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for     the treatment of bacterial vaginosis   "
15642|NCT03080727|"     The functional assessment of the hip joint is complex and challenging. Reproducible measures     are necessary to identify changes in the structures and functionality of the hip joint over     time and to evaluate the outcomes of treatments. A systematic evaluation process is critical     to evidence-based practice. However, there are few studies investigating the reproducibility     of these measures such as muscle strength, range of motion (ROM) and hip functionality in     healthy subjects.   "
15643|NCT03080714|"     To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1     Maestro with RDB.   "
15644|NCT03080701|"     The investigators propose to build on the success of the Systems of Support to Increase     Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less     likely to be current for colorectal cancer (CRC) screening. We will test whether financial     incentives increases screening uptake and decreases screening disparities. The investigators     hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and     financial incentives than those offered mailed fecal kits alone.   "
16157|NCT03074006|"     This is a prospective, open-label, multicenter, phase 1/2 study of TEW-7197 in patients with     low and intermediate risk of myelodysplastic syndrome (MDS).   "
15645|NCT03080688|"     This study is intended to evaluate performance of the new design sufficiently to support     performance claims for an FDA 510K submission or ISO technical file. Specifically:        -  SpO2 value range 70% to 100%        -  10 or more subjects, at least 3 of dark pigmentation        -  At least 200 data points        -  Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters -          Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters:        -  2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions:             -  4.1. ACCURACY OF PULSE OXIMETERS             -  4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS        -  ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2             -  201.12.1.101 SpO2 accuracy of pulse oximeter equipment             -  201.12.1.101.2 Determination of SpO2 accuracy   "
15646|NCT03080675|"     To show the efficacy of a 4-year intervention with nutritional blend of ingredients to     prevent cognitive decline.   "
15647|NCT03080662|"     The impact of the reduction of daily physical activity (DPA) in patients with COPD (chronic     obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of     life and the clinical evolution of the disease . This fact has multifactorial components: its     function is naturally diminished with time, and its effects on the loss of physical condition     (decondition). However, dynamic hyperinflation and respiratory muscular dysfunction,     especially in patients with more symptomatology, have been identified as those that have the     most relevant factors that impact on daily physical activity Due to the detrimental effects     of the pulmonary hyperinflation, the diaphragm is flatter and shorter, being in a position of     mechanical disadvantage. This contributes to a reduced effort capacity and increase in the     dyspnea of patients during daily activities.      Resistance training improves their exercise capacity and reduces dyspnea, however it does not     improve inspiratory muscle strength. It is for this reason, that specific training of the     inspiratory muscles, offers special interest in patients with decreased inspiratory muscle     strength and pulmonary hyperinflation.   "
15653|NCT03080584|"     the investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the     ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before     and after 12 weeks of acupuncture and the clinical response to controlled ovarian     hyperstimulation before and after the acupuncture is compared.   "
24955|NCT02959034|"     The aim of this project is to establish a bio-repository of diverse specimen types to provide     investigators access to specimens in order to further research related to metabolism and the     microbiome in the pediatric population.   "
15654|NCT03080571|"     Stroke is a leading cause of morbidity and mortality.Acute ischemia causes irreversible     damage to neurons and glial cells, leading to functional deficits and chronic sequelae with     variable degrees of spontaneous recovery of function. Stem cells have been shown to enhance     recovery through multiple immunomodulatory effects, neoangiogenesis and neurogenesis.      We conducted a prospective randomised end observer blinded study to evaluate primarily the     safety of intraarterial autologous stem cells delivered to ipsilateral middle cerebral artery     in acute and subacute stroke patients (0-15 days post ictus).Secondarily we aimed to evaluate     the outcome on the basis of clinical evaluation and follow up imaging   "
15655|NCT03080558|"     Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of     tissue perfusion.      After intravenous injection of indocyanine green, using a near infrared light, the     vascularisation becomes fluorescent.      In endometriosis disease, the treatment of recto vaginal node can be complicated by     rectovaginal fistula.      An abnormal vascularisation related to the surgery would be a risk factor of post operative     fistulas.      The aim of this study is to evaluate the rectal and vaginal vascularisation during the     treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine     green fluorescence.   "
15656|NCT03080545|"     Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar     topical foam for 16 weeks.   "
15657|NCT03080532|"     Despite the strong evidence on health benefits of traditional MeD, not many studies have     broadly and systematically been made for the potential role and relationship of the MeD in     the composition of the gut microbiota.      Furthermore, little is known about the composition of the gut microbiota in individuals with     defined dietary habits on the Mediterranean pattern.      This work is aiming at comparatively studying the gut microbiota of three different dietary     oriented european populations. In particular, biological samples and related information will     be collected from populations with high adherence to Mediterranean diet (MeD) in Crete -     Greece and Molise region - Italy. These data will be comparatively assessed with those     provided by a sample population with high adherence to Western diet in Auvergne - France.   "
15658|NCT03080519|"     A multicenter prospective registry planned to recruit more than 5 000 patients with renal     artery stenosis was carried out in China. This primary purpose of this study was to evaluate     the safety and efficacy of renal artery revascularization in the real world. The secondary     purpose was to investigate the etiologic distribution of renal artery stenosis and optimize     the indications for renal artery revascularization.   "
15659|NCT03080506|"     Cesarean delivery is a common obstetrical procedure and is associated with increased maternal     morbidity and mortality. Pain and limited mobilization are major contributing factors that     result in delayed functional recovery and complications. Elastic abdominal binder, a wide     elastic belt that is wore around the patient's abdomen to support surgical incision after     surgery, has been employed by clinicians for pain relief, wound complications prevention,     improved pulmonary function, and stabilization. Benefits of the abdominal binder use have not     been properly examined.      The aim of this study is to examine the effect of postcesarean elastic abdominal binder use     on recovery by comparing pain scores and mobility function (through the 6-minute walk test     [6MWT]) in postcesarean mothers who use versus do not use the elastic abdominal binder to     support incisional site.   "
15705|NCT03079908|"     Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery     training, both for conventional laparoscopic and robotically-assisted surgery. Although     numerous studies have analysed the impact of VRSS training on surgical skills, there is a     lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS)     training on conventional laparoscopic skills among subjects with no prior surgical     experience. The hypothesis of the present study is that RVRSS could improve conventional     laparoscopic skills as much as laparoscopic LVRSS among naïve subjects   "
15660|NCT03080493|"     Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age     on the day of their procedure commonly have dilators placed in their cervix overnight before     the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after     women go home they expand slowly overnight to open the cervix before the abortion procedure     the next day. This can be a painful experience and health care providers often give women     different kinds of pain medicine to help them.      The investigators are interested in whether a medicine called gabapentin, which is a     non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug     Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are     also using it to decrease pain for people having surgical procedures.      The main goals of our study are to learn about:        1. Women's pain experience with dilators in their cervix overnight before the abortion          procedure        2. How well gabapentin works to decrease women's pain while they have the dilators in their          cervix      Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no     medicine in it) before their dilators are placed in the clinic. The medication they get     (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in     the study nor the doctors giving them the medication will know which medication they receive     so the investigators can learn about their pain without being influenced by knowing which     medication they take. Doctors will be able to find out which medication women got if there is     an emergency or if it changes their medical care.      The investigators will communicate with women in real time overnight by text messaging to see     how much pain they are having in the moment and how much pain medicine they are taking.      The investigators hypothesize that women who receive gabapentin will have a smaller increase     in their pain with the dilators than women who receive placebo (a pill with no medicine in     it).      Our findings will help doctors understand women's pain experience with dilators better and     possibly provide a new way of treating pain with gabapentin.   "
15661|NCT03080480|"     The purpose of this proposed research is to investigate the efficacy and safety of the     therapy with pioglitazone for chronic granulomatous disease (CGD) patients severe infection.   "
15662|NCT03080467|"     This project is an observational trial investigating wound cosmetic appearance after repair     of traumatic skin lacerations in the head area of pediatric patients with two different     approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two     follow-up visits after repair and later assessed by external blinded plastic surgeon using     standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound     outcome will be equivalent in these two wound repair treatment options.   "
15663|NCT03080454|"     The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker DoubleStim     treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal     direct current stimulation) and of the median nerve at the peripheral wrist (pDCS--     peripheral direct current stimulation), can significantly reduce spasticity of the wrist and     hand after stroke.   "
15664|NCT03080441|"     This is a research study to test the application of FDA-approved, non-invasive device (NICaS)     that measure the performance of your heart during HD treatment.   "
15678|NCT03080259|"     The purpose of this study is to test clinical strategies that pediatric providers may use to     prevent misuse and diversion of stimulants by their adolescent patients with ADHD.   "
15679|NCT03080246|"     The purpose of this study is to look at the effect of strength training in preventing overuse     injuries in female runners   "
15824|NCT03078361|"     The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per     focus group to explore community members' views about colorectal cancer screening (CRCS)     processes and perceived benefits and impediments, what information they believe should be     communicated, communication preferences (style, tone) and perceptions of screenings.   "
15665|NCT03080428|"     The need/benefit of adjuvant chemotherapy could be negligible for a certain category of     patient with newly diagnosed unilateral non metastatic breast cancer. Physicians are     sometimes divided between the administration of adjuvant treatment and no administration when     the risk of distant relapse at 10 years is around 10% with uncertainty and a theoretical     benefit of chemotherapy is less than 5% at 10 years according to guidelines in use in the     center.      Several genomic tests have been developed this last decade. These tests use a sample of     breast cancer tissue to analyze the activity of a group of genes. Knowing whether certain     genes are present or absent, overly active or not active enough, can help physicians predict     the risk of recurrence.      In addition to standard pathological characteristics, a genomic test could be helpful in     making treatment decisions, such as whether or not chemotherapy should be part of the     treatment plan. First generation prognostic tests are currently widely used worldwide to     guide decision making regarding adjuvant chemotherapy (OncotypeDX™ Mammaprint®). Prognostic     tests have reached a level of evidence 1A, with the results of the prospective randomized     trial Mindact. In the Mindact trial, among women with early-stage breast cancer who were     at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on     the basis of the 70-gene signature led to a 5-year rate of survival without distant     metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these     findings, approximately 46% of women with breast cancer who are at high clinical risk might     not require chemotherapy. The health-economic value of such signatures in the general     population of patients with localized breast cancer appears very low at current costs.      Meanwhile, next generation prognostic signatures have been developed that have integrated     clinical parameters and suggest high added value beyond all standard and traditional     characteristics including tumor burden, grade, Estrogen Receptor (ER) and Progesterone     Receptor (PR), Her2, age and also standard assessment of proliferation.      In this study, the clinical utility of genomic tests (Endopredict®, Prosigna®, OncotypeDX®,     Mammaprint® assay) defined as impact on chemotherapy decision in the adjuvant setting in     patients with ER-positive, Her2-negative early breast cancer with uncertainty on the     indication of chemotherapy using standard assessments will be compared.   "
15666|NCT03080415|"     This is an open, uncontrolled pilot study of thirty chronic HCV infected patients carried out     at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study     is to investigate the safety & efficacy of combined therapy sofosbuvir (SOF) and daclatasvir     (DCV) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results     in other clinical studies of this drug it is expected that the drug will have high safety and     high efficacy. Safety will be measured by checking for adverse effects, while efficacy will     be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral     nucleic acids in blood samples.   "
15667|NCT03080402|"     A prospective trial will be used to evaluate the efficacy of prophylactic mechanical     perturbation training program. 24 female athletes who are regular participants in activities     that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in     age from 15-30 year are eligible. Using a prospective risk stratification design, female     athletes with knee abduction moment (KAM) > 25.25 Nm from drop jump motion analysis will be     classified as high KAM and will receive 12 sessions of mechanically-driven perturbation     training and female athletes with KAM < 25.25 Nm from drop jump motion analysis will be     classified as normal KAM and only participate in baseline performance testing, followed 6     weeks later by another session of drop jump motion analysis and performance testing.   "
15668|NCT03080389|"     There is some evidence to suggest standard urine cultures may not be adequate in identifying     patients with low grade urinary tract infections. Therefore, there are patients with symptoms     of frequency and urgency, being misdiagnosed with overactive bladder due to negative urine     cultures. If this is true, could extended cultures be used to identify the false negative     patients?   "
15669|NCT03080376|"     Aim: To evaluate the impact of a physical exercise Web-based program with or without support     on body composition, physical fitness and blood pressure values.      Design: Randomized Controlled Trial. Population: Obese children and adolescents.   "
15670|NCT03080363|"     Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract     calculi; however, the vast majority of patients do not tolerate the procedure without     analgesia and sedation.      Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs,     opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local     anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine     cream).      The quadratus lumborum block was first described by Blanco. QL block is performed as one of     the perioperative pain management procedures for abdominal surgery. QL block provides     anesthesia and analgesia on the anterior and lateral wall of the abdomen.   "
15671|NCT03080350|"     The purpose of this study is to determine the non-inferiority of the efficacy for prehospital     analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for     patients with limb trauma on the slope   "
15672|NCT03080337|"     This study aims to use an innovative and integrated educational curriculum to deliver     prenatal care and diabetes care for pre-gestational diabetic women from approximately the     first trimester of pregnancy through delivery and the early postpartum period in a group care     model. The group care model will be compared to a control group, a traditional, individual     care model.   "
15673|NCT03080324|"     The purpose of this study is to determine the non-inferiority of the efficacy of sublingual     given fentanyl versus endovenous given fentanyl for patients in the emergency departement.   "
15674|NCT03080311|"     APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which     shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown     that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor     xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast     and ALL cancer xenografts; achieves strong synergy with the chemotherapeutic agents,     indicating that APG-1252 may have a broad therapeutic potential for the treatment of human     cancer as a single agent and in combination with other classes of anticancer drugs. APG-1252     is intended for the treatment of patients with SCLC or other solid tumors. Upon completion of     the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD),     dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II     studies will be implemented accordingly.   "
15675|NCT03080298|"     This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in     patients with a decrease or loss of sexual desire.   "
15676|NCT03080285|"     This is a study to investigate efficacy of over-glasses patch treatment for amblyopic     children using visual function improvement and Amblyopia Treatment Index (ATI) changes.   "
15677|NCT03080272|"     With this study the investigators want to perform a prospective cross-sectional audit at     Zealand University Hospital, Koege, Denmark. The aim is to investigate the actual pain     treatment and outcomes from a representative number of surgical procedures from different     surgical departments.   "
15680|NCT03080233|"     This is a observational validation study. The Stroke Clinical Decision Support Tool (     InstaDx) , an information technology application will be adapted and developed in accordance     to evidence based clinical practice guidelines ( Level IA). Neurology Residents will be using     the InstaDx CDST to improve their diagnostic accuracy and the findings will be validated     against the review of a stroke subject expert. The study hypothesis is that Clinical Decision     Support Tool used by neurology residents will have an agreement of >0.77 when compared to     Stroke Expert (gold standard) in diagnosing type of ischemic stroke.   "
15681|NCT03080220|"     The purpose of this study is to investigate the effects of Astym® treatment, The Stick®     treatment and massage treatment on performance among healthy college athletes and to     investigate any relationship between functional movement and functional performance.     Participants will be recruited from Division II, National Association of Intercollegiate     Athletics (NAIA) basketball and volleyball teams. The participants will be randomized into     one of three groups: Astym treatment (AT), The Stick treatment (ST) or massage treatment     (MT). The participant will have baseline measures of vertical jump (VJ), Y-Balance Lower     Quarter Screen (YBLQ), and a rating of current perceived lower extremity function using a     visual analog scale (PLEF-VAS). The participants will be treated using either the AT, ST, or     MT following baseline measures. Immediately following the intervention, a second measurement     of VJ, YBLQ, and PLEF-VAS will take place. The data will be analyzed using mixed ANOVA tests     which will be conducted for each dependent variable. In addition, functional movement is     thought to be related to functional performance. A Pearson Product Correlation analysis will     be used to understand any relationship between YBLQ and VJ. It is hypothesized that those in     the AT group will have different percent change in their YBLQ, VJ, and PLEF-VAS compared to     those in ST and MT groups. It is hypothesized that a correlation between YBLQ and VJ will     exist. As a result, clinicians could use AT among basketball and volleyball athletes without     hindering acute performance. Any risks the participants could encounter are minimal.     Participants may withdraw themselves and their data at any time. The intervention and testing     are similar to what an athlete would be exposed to during their collegiate career. Any     participant injured during this study will be referred to their university sports medicine     staff, health center, or the Indiana Wesleyan University health center.   "
15682|NCT03080207|"     At the end of the study, comparative information about the effects of PRP, complex     decongestive physiotherapy and low level laser on edema volume, range of motion, muscle     strength, functional capacity and quality of life will be obtained in the treatment of     patients with lower limb lymphedema.      Since there is no study about this field in the literature, this study will provide new and     valuable contributions about treatment of lower extremity lymphedema for the researchers and     clinicians.   "
15683|NCT03080194|"     This is a 12-month open-label randomized controlled study. Patients with schizophrenia and     violence risk under the government supervision will be enrolled in the study. A     community-based long-acting antipsychotics-treated management model will be applied to the     experimental group, which means that professional psychiatrists will provide guidance to     primary-level mental health workers on the psychotic treatment, and monthly-injected     long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia     treatment. Every subject in experimental group will be equipped with an intelligent robot     capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact     doctors for assistance at any time.      The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone     palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of     paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to     clinical judgement.      Subjects in control group will be treated with oral antipsychotics or other conventional     medication.   "
16051|NCT03075384|"     Many studies show that computer-assisted navigation system have been available to treat     zygomatic-complex fractures. However, most of them are case reports or clinical experiences     lacking multiple variables and controlled design. The aim of this study was to evaluate the     accuracy of the computer-assisted navigation system by a randomized controlled trial with     multiple variables.   "
15684|NCT03080181|"     Background: Pasireotide treatment is strictly associated with glucose metabolism impairment.     The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose     function in patients with Cushing's disease (CD).      Methods: Clinical and hormonal parameters, insulin secretion, evaluated by homostasis model     assessment (HOMA-β) and by the area under the curve (AUC2h) of C-peptide during a mixed meal     tolerance test and insulin sensitivity, evaluated by the euglycemic hyperinsulinemic clamp,     were evaluated in 12 patients with active CD before and after 12 months of pasireotide.      Circulating adipokines were evaluated in patients with CD compared to a matched group of 12     diabetic patients.   "
15685|NCT03080168|"     This is a research project looking at whether measuring movements or responses to certain     questions can help predict suicidal thoughts or actions.      This project has two parts: The first part will occur while the participant is receiving     hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her     wrist and answering questions or doing tasks to measure mood and other mental health     symptoms, and suicidal thoughts.      In the second phase, the investigators will call the participant around 12 months after s/he     has left the hospital. The investigators will discuss how s/he is doing and if s/he has had     suicidal thoughts or made suicidal acts.   "
15686|NCT03080155|"     The purpose of the study is to assess the effectiveness of MIRA in classifying women with     dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for     correctly classifying women with breast cancer and to evaluate the safety of the device.      In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle     biopsy due to lesions detected by other imaging modalities.   "
15687|NCT03080142|"     This is a prospective randomized study designed to compare the pain control from a single     shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters     with ropivicaine bolus in patients undergoing elective colorectal surgery.   "
15688|NCT03080129|"     Protein-energy malnutrition (PEM) occurs in 65-90% of patients with liver cirrhosis. Severity     of malnutrition correlates with progression of liver disease and leads to sarcopenia in     30-70% of cirrhotic patients. Malnutrition and sarcopenia are associated with an increased     risk of complications and mortality.      In cirrhosis the gut microbiome is altered leading to increased gut permeability, bacterial     translocation and inflammation. Since the microbiome is involved in nutrient uptake and     metabolism, it is hypothesized that microbiome alterations contribute to sarcopenia. A     prospective controlled cohort study to investigate the interrelation of microbiome changes     and sarcopenia in cirrhosis will be conducted. Furthermore the effect of nutritional     interventions on the microbiome in cirrhosis will be studied. From this study information on     how the gut microbiome composition and sarcopenia are associated in cirrhosis and if     modulation of the gut microbiome by nutritional interventions is feasible will be collected.   "
15728|NCT03079609|"     This study is to answer the question is there any relationship between viral ( HSV 1 , HSV 2     , HPV 6/11, CMV, HHV 6 , HHV 8, BKV) or bacterial (Porphyromonas gingivalis, Treponema     denticola, Tannerella forsythia, Fusobacterium nucleatum) infection and occurrence of     varicocele in men.   "
15729|NCT03079596|"     Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of     reducing the surgical stress response and obtaining optimal recovery after surgery.   "
15689|NCT03080116|"     RATIONALE: Neoadjuvant hormonal therapy using luteinizing hormone releasing hormone (LHRH)     agonists and/or anti-androgens has already demonstrated to downstage primary prostate cancer     in patients treated by radical prostatectomy without a survival benefit. There is no evidence     yet of a survival impact of LHRH antagonist (LHRHa) +/- new-generation anti-androgens in this     setting. Thus novel studies are needed to assess this treatment combination.      PURPOSE: To assess the difference in treatment antitumor effect between arms by measuring     pathological tumor volume with minimal residual disease (MRD) following radical prostatectomy     + pelvic lymph-node dissection (RP + PLND) for intermediate or high-risk prostate cancer     patients.   "
15690|NCT03080103|"     On September the 15th, 2015, Italian surgeons, radiologists and pathologists with a special     interest and expertise in the diagnosis and management of Acute Appendicitis (AA), met up     under the auspices of the Italian Society of Hospital Surgeons (ACOI) in Oristano (Italy) to     constitute the ACTUAA collaborative working group. The main objectives of the working group     are:      To create a working basis for analyzing the diagnostic features, treatment modalities and     outcomes of interest of both the antibiotic-first approach and appendectomy for patients with     uncomplicated AA.      To investigate the clinical, laboratory and radiologic modalities adopted for the diagnosis     To determine the outcomes of patients treated with antibiotics or appendectomy in the short     and long term periods.      To compare results according to the type of intervention. To stratify the risk of recurrence     for patients treated with antibiotics according to clinical, laboratory and radiology     findings.      To evaluate the sensibility and specificity of clinical and laboratory scores for the     diagnosis of uncomplicated AA.      To identify a subgroup of patients with uncomplicated AA for whom antibiotic treatment can be     highly effective.      General study design The study protocol is designed according to the SPIRIT 2013 explanation     and elaboration: guidance for protocols of clinical trials.      The study period is estimated to be of 12 month + 12 month of follow-up (with a second     session of follow-up following 5-years), beginning on 01/04/2017.      Participants All adult patients (aged over 18 years old) with suspected AA will be admitted     to the Surgical Department of the twelve participating Italian hospitals, where they will be     studied carefully by the on call surgeon.      Patients will be then informed of the study protocol and invited to give written consent for     participation and for sensible data collection for scientific purposes.      Subsequently, only patients who will undergo diagnostic imaging (as specified later) and from     whom a written informed consent will be obtained, can be enrolled in the study and registered     by each Center using a uniform electronic registration form and database.      General characteristics, medical history, clinical findings, physical investigation, and     blood tests will be reported in the medical record. Pain will be quantified by Visual     Analogue Scale (VAS) scoring system before administrating any pain medications and after the     treatments.      In order to enter the study, patients will have to undergo diagnostic imaging (US and/or CT     scan or MRI scan) and only the diagnosis of uncomplicated AA confirmed by diagnostic imaging     will permit patient enrollment in the study.      Specific aims of the ACTUAA Study The objective of this prospective non-randomized     controlled, multicenter, multidisciplinary trial is to compare the antibiotic therapy and     emergency appendectomy for the treatment of patients with uncomplicated AA(without abscess or     free perforation), confirmed by US and/or CT or MRI scan. No changes in the daily practice     regarding the diagnostic, clinical and treatment pathways will be required to the     participating centers. However, only the patients with uncomplicated AA, confirmed by one of     the above mentioned radiologic tools will be enrolled in the study. The decision on which of     the tools are to be adopted will be up to the local lead surgeon.      Primary Outcome Measure:      Number of participants with complication-free treatment success, defined as success of the     initial treatment with uncomplicated course.      Secondary Outcome Measures:      Length of hospital stay; Pain evaluation; Time to return to normal activity; Period of     sick-leave; Complicated appendicitis with peritonitis identified at the time of surgical     operation; Quality of life as assessed by the Short Form 12-scale (SF-12)   "
15691|NCT03080090|"     Cigarette smoking is the leading cause of death and disability in the United States. Although     smoking has declined since 1964, it is still very common among some groups of people. One     such group is persons with emotional symptoms and disorders. There has been little success in     developing treatments for smoking cessation for smokers with affective disturbances.      Recent work suggests that being sensitive to, and less tolerant of, stress is associated with     many problems in daily life. People with high 'stress sensitivity' tend to use avoidant     strategies to cope with their stress, like smoking. Also, people with high levels of stress     sensitivity report stronger beliefs that smoking will reduce negative feelings. They also     report having a harder time quitting and in fact, are less successful at doing so. This     information suggests that stress sensitivity is important to target during smoking cessation     treatment for smokers with affective vulnerabilities.      This clinical trial will evaluate a treatment that integrates exercise to reduce stress     sensitivity among high stress sensitive smokers. It builds directly from our recent work and     we now seek to adapt it to a more a more accessible and sustainable application. Results will     provide important information on the benefit of an integrated intervention that could be used     in the community for smokers at great risk for relapse and who do not benefit from existing     alternative treatments. This study is the first to test an intervention for stress sensitive     smokers and has the potential to help at-risk individuals experience quitting success and,     ultimately, reduce the burden of tobacco-related cancers in Texas.   "
15692|NCT03080077|"     This prospective, randomized study is being conducted to evaluate the safety and     effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive     ectasia (post-LASIK or PRK) utilizing two techniques: the standard Epi-Off technique or an     Epi-On technique that utilizes iontophoresis (I-CXL) to deliver the riboflavin to the cornea     without need for removal of the corneal epithelium. Patients will be randomized to receive     CXL treatment with either the Epi-On or Epi-Off technique.   "
15706|NCT03079895|"     This project will study the effectiveness of computerized cognitive behavioral therapy (CBT)     in reducing depression symptoms. The design is a two-arm randomized controlled trial     comparing (i) control arm, which is treatment as usual with (ii) treatment arm, which is     treatment as usual plus computerized CBT. The primary outcome measure is change in depression     symptom severity. The name of the computerized CBT program to be used in the study is Thrive.   "
15693|NCT03080064|"     In this mixed methods study, the investigators assessed the feasibility and acceptability of     a remote health coach intervention to promote healthful lifestyle behaviors among overweight     pregnant women. At one northeastern US clinic, the investigators enrolled 30 overweight     (pre-pregnancy BMI≥25 kg/m2) pregnant women at a median gestation of 12.5 weeks (IQR: 11-15)     into a one arm intervention trial. The investigators connected participants with a health     coach to provide behavioral support to help participants adopt or maintain healthy lifestyle     goals during pregnancy. Health coaches contacted participants by phone every 2-3 weeks to     monitor goals, and sent emails and text messages to check-in between calls. To assess the     intervention, participants completed baseline (N=30) and follow-up surveys at the end of the     intervention (N=26), as well as follow-up phone interviews (N=18).   "
15694|NCT03080051|"     The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as     [18F]UCB-K), a tau targeted PET radioligand.   "
15695|NCT03080038|"     The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results     in the best outcomes for children treated for suspected or confirmed septic shock. In this     study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid     Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock     Resuscitation Guidelines, with the assigned resuscitation strategy used to guide     administration of further fluid boluses as well as the timing of initiation and escalation of     vasoactive medications to achieve ACCM recommended hemodynamic targets.   "
15696|NCT03080025|"     The purpose of this study is to determine how a CBCT® (Cognitively Based Compassion-Training)     for couples affect aspects of health and especially social interactions in depressed female     patients and their romantic partners. compare healthy and depressed couples during an     instructed positive real-time social interaction in the laboratory.      Furthermore the investigators aim to examine how social behavior and psychobiological     indicators of health during real-time social interaction in the laboratory might be improved     through CBCT® for couples.   "
15697|NCT03080012|"     In tuberculosis patients, salivary concentrations will be compared to plasma/serum     concentrations of several anti-tuberculosis drugs. If salivary concentrations correctly     represent blood concentrations, this non-invasive sampling of saliva could be used for TDM of     the tested drugs.   "
15698|NCT03079999|"     This is a phase II prospective, randomized, double-blind, longitudinal study evaluating     whether the administration of aspirin can delay or slow tumor growth and maintain or improve     hearing in VS patients.   "
15699|NCT03079986|"     Currently it is unclear whether postoperative chyle leak (CL) after pancreatic surgery     requires treatment. Thus, the present study aims to compare dietary treatment of CL with     drain removal despite of persistent CL.   "
15700|NCT03079973|"     The objective of this phase III study is to evaluate the efficacy, systemic safety and local     tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate     psoriatic fingernail/s.   "
15730|NCT03079583|"     To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants     from a rural area of Bangladesh.   "
15731|NCT03079570|"     The objective of this study is to determine which luminance levels yield maximum differences     in critical flicker fusion (CFF) scores between younger and older normal subjects.   "
15732|NCT03079557|"     This is a pilot testing the feasibility of the 'REpurposing BOtulinum Toxin in Treatment of     Obesity in Adolescents' trial (ReBOO-trial). The full-scale ReBOO will further investigate     safety and efficacy of intragastric injections of botulinum toxin A into the antrum area of     the stomach. These injections will be repeated every six months.      The study sample will be adolescents with obesity who have not responded to standard     conservative treatment.   "
15701|NCT03079960|"     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has developed into a standard     therapy in the refractory stage of Parkinson's disease (PD). Implanted micro- and     macroelectrodes can be used to derive neural signals from the basal ganglia (BG). Cortical     signals can be obtained by measurements of the electroencephalogram (EEG) or the     electrocorticogram (ECoG). Both signal types can be used to characterize the motor system of     the patient and make it possible to estimate the effectiveness of a currently performed DBS.     However, the relationship between such neuronal features on the one hand and the DBS     stimulation parameters or the observable clinical effects on the other hand is very     individual and varies from patient to patient.      The aim of the present study is to: (1) determine neuronal characteristics that are     informative about the clinically relevant motor status of PD patients. (2) The investigation     and description of the complex non-stationary dynamics of neuronal characteristics as a     consequence of changing DBS stimulation parameters. (3) The study of the effect of changing     DBS stimulation parameters on motor performance.      The three objectives form an important building block for future adaptive closed-loop DBS     strategies (aDBS). Here, the stimulation parameters are to be adapted in the single-trial and     depending on the currently detected motor state of the patient. Since this is accessible only     to a very limited extent, it is to be investigated whether information about the motor state     can be obtained from the neural features.   "
15702|NCT03079947|"     The purpose of this study is to evaluate the effectiveness of circulating DNA from peripheral     blood for predicting the prognosis and relapse in DLBCL and PTCL patients.   "
15703|NCT03079934|"     Evaluation of coronary artery vessel wall healing at different time points in patients     undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging   "
15704|NCT03079921|"     To determine the effect of sympathetic neural and hormonal (epinephrine) input on islet cell     hormonal responses to insulin-induced hypoglycemia in type 1 diabetic recipients of     intrahepatic islet transplantation. We hypothesize that α-adrenergic (neural) blockage will     abolish insulin-mediated suppression of C-peptide, attenuating α-cell glucagon secretion     during hypoglycemia, and that β-adrenergic (hormonal) blockage will have no effect. Glucose     counterregulatory responses will be measured during hyperinsulinemic euglycemic-hypoglycemic     clamps on three occasions with randomized, double-blind administration of the α-adrenergic     blocker phentolamine, the β-adrenergic blocker propranolol, or placebo. The demonstration of     neural rather than hormonal regulation of the transplanted islet cell response to     hypoglycemia is critical for understanding the mechanism for protection from hypoglycemia     afforded by intrahepatically transplanted.   "
15707|NCT03079882|"     Ten percent of American adults, more than 20 million people, have chronic kidney disease,     which in the advanced state of end stage renal disease is most desirably and cost-effectively     treated by kidney transplantation. However, 20-30% of transplanted kidneys fail in living     recipients by 10 years, owing largely to insufficient monitoring methods. The goal of the     proposed research is to improve noninvasive kidney transplant monitoring using a new     ultrasound-based imaging method called Viscoelastic Response (VisR) ultrasound.   "
15708|NCT03079869|"     Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4     Real World Experience Study from Kaiser Permanente Southern California   "
15709|NCT03079856|"     This project will develop a technology-augmented HIV and substance use risk reduction     intervention for delivery in the Emergency Department, a medical setting where at-risk     emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present.   "
15710|NCT03079843|"     Healthy volunteers will be exposed to ambient air near a roadway under the conditions of with     and without a facemask and their responses will be evaluated.   "
15711|NCT03079830|"     The study evaluates the efficacy of local anesthestic application through the catheter in the     surgical wound for the postoperative pain relief after minimally invasive aortic valve     surgery. The patients will be enrolled in two different groups according to the protocol of     the local anesthetic and saline administration:        1. group: continous infusion of the local anesthetic plus bolus on demand        2. group: continous infusion of saline plus bolus on demand For all patients metamizol          every 12 hours plus bolous of piritramid on demand.   "
15712|NCT03079817|"     In past work is has been shown that yoga can be as effective as a standard balance or Tai Chi     protocol; however, there is an inability to distinguish between the mind and body     contributions of yoga training. This study will compare an accepted proprioceptive training     program to a meditation program which concentrates on body awareness in individuals with     Parkinson's disease.   "
15713|NCT03079804|"     The ankle joint is often affected by injuries, especially lateral sprains, often leading to     chronic instability. Joint mobilization techniques seem to influence the sense of joint     positioning. The objective of the study is to compare mobilization techniques in the balance     of athletes with chronic ankle instability. A randomized clinical trial with participants     allocated in three groups: Talocrural manipulation, mobilization with movement and placebo     will be assessed in their primary endpoints and secondary balance and dorsiflexion range of     motion respectively.   "
15714|NCT03079791|"     The aim of this study is to use the high resolution of optical coherence tomography to assess     the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac     transplanted patients and correlate those results with the level of immunosuppression   "
15715|NCT03079778|"     Hypothesis: Patients with hepatocellular carcinoma (HCC) have few options if they fail or are     unable to undertake surgery, transarterial chemoembolization (TACE) and/or chemotherapy.     Radiation (RT) in a range of doses has been combined with TACE in several case cohort studies     demonstrating safety and a dramatic improvement in survival. Clearly these trials are subject     to bias due to non-randomized selection, possible lack of generalizability to Canadian     patients, and heterogeneous patient populations.      Objective: Therefore, there is a high priority need to investigate the addition of RT to TACE     in a randomized fashion to determine if we can improve survival in this rapidly growing poor     prognosis patient population that have no other options.      Methodology: TACE eligible patients with HCC will be randomized to TACE alone or TACE plus     radiation (TACERT). They cannot be eligible for standard treatments such as transplant and     resection. Primary endpoint will be time-to-intrahepatic-progression. Secondary endpoints     will be response rate (Modified RECIST criteria), overall survival, local failure,     extrahepatic failure, toxicity, quality of life and economic feasibility.   "
15716|NCT03079765|"     This study evaluates the effects of delivering training services via telehealth to educators     in rural schools. The investigators hope to increase the accuracy with which educators     implement functional behavior assessments in schools. During the study, participants will     receive training on functional behavior assessments at different periods. When one school is     receiving training, other schools will not be receiving training. The purpose will be to show     increased accuracy of functional behavior assessments only occur following training.   "
15717|NCT03079752|"     The Nurse-Family Partnership, a program of prenatal and infancy home visiting by nurses, has     been examined in a series of 3 randomized trials since 1977. It has received considerable     attention in the scientific and public policy communities for its replicated effects on a     variety of maternal and child health outcomes across these 3 trials, including prenatal     health, childhood injuries, rates of subsequent pregnancies, inter-birth intervals, as well     as its long-term effects on maternal life-course, criminal behavior, and 15-year-olds'     criminal and antisocial behavior in the first trial of the program conducted in Elmira, New     York.   "
15718|NCT03079739|"     Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to     optimal medical therapy reduces major adverse cardiac events. However, less than half of     patients have a noninvasive ischemic evaluation before revascularization. Fractional flow     reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring     the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies     conducted principally in stable coronary artery disease (CAD) patients have demonstrated that     FFR-guided revascularization improves clinical outcomes, quality of life, and     cost-efficiency. However, the reliability and safety of FFR assessment in different setting     than stable CAD is unclear. In addition, the majority of studies are performed with the only     one device. No data are available from other clinically used devices. The HALE BOPP registry     is an investigator-initiated observational study, designed to prospectively include all     patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.   "
15719|NCT03079726|"     This is an investigation to examine the correlation and predictive ability of activity     measures obtained from cardiovascular implantable electrical devices.   "
16052|NCT03075371|"     The goal of the present study is to investigate metabolic gut-brain signaling and the neural     correlates of distraction from visual food cues in patients with Anorexia nervosa and healthy     controls.   "
15720|NCT03079713|"     Intravitreal injections are an efficient method of delivering therapeutic levels of     medications to the posterior segment of the eye. Prior to receiving an injection, there are     various methods to provide ocular anesthesia. Vibration may have an anti-nociceptive effect     by directly decreasing the sensitivity of peripheral nociceptors or by reducing signal     transmission from peripheral nociceptors to the brain with activation of vibratory sensation     pathways. The purpose of this study is to evaluate the use of a handheld fingertip vibrator     compared to topical eye drops for pain control while performing intravitreal eye injections.     A secondary objective of the study is to measure corneal and conjunctiva sensitivity with and     without activation of the vibrator to the lower lid using a Luneau Cochet-Bonnet     aesthesiometer.   "
15721|NCT03079700|"     Mucosal immunology during helminth infection   "
15722|NCT03079687|"     This is an open-label, single-arm, international, multicenter Multiple Patient Expanded     Access Program (MPEAP). The program is designed to provide treatment access to olaparib     tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian,     fallopian tube or primary peritoneal cancer without other treatment options or eligible for     an olaparib clinical trials.   "
15723|NCT03079674|"     The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly     increased. In order to achieve accurate risk stratification and effective treatments,     developing new diagnostic, therapeutic, and prognostic strategies is indispensable. Chinese     registry of NICE is a national multi-center prospective study aimed to explore the     epidemiology, new biomarkers, risk factors and prognostic models.   "
15724|NCT03079661|"     All COPD patients with a diagnosis of acute exacerbation in emergency room in University     Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect     for each patient the home address and the work address. The duration of 1 year was chosen to     take into account seasonal variations. In parallel, a daily report of the rate of ozone,     particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO     Picardie.   "
15725|NCT03079648|"     This study was conducted to investigate the effects of daily supplementation of Angelica     gigas N. extract on improvement of Blood Triglyceride.   "
15726|NCT03079635|"     The purpose of this research is to determine if body composition influence the effect of     breakfast composition on postprandial (post-meal) hunger, metabolic and energy expenditure     response in normal weight, overweight, and obese young women.   "
15727|NCT03079622|"     The study titled, Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between     10-14 weeks: A Randomized Trial, is a randomized trial to compare procedure times for manual     and electric vacuum aspiration for surgical abortion between 10 0/7 and 13 6/7 weeks     gestation. Women presenting for surgical abortion between 10 0/7 and 13 6/7 weeks gestation     will be randomized to either undergo manual vacuum aspiration (MVA) or electric vacuum     aspiration (EVA). The investigators hypothesize that operative times will be increased when     using manual vacuum aspiration, as compared to electric vacuum aspiration, for surgical     abortion performed in the late first trimester (10 0/7 and-13 6/7 weeks).   "
15736|NCT03079505|"     DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus     Dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both     drugs will be tested by measuring BCR/ABL (BCR-ABL = fusion gene from BCR (breakpoint cluster     region gene/BCR gene product) and ABL (Abelson proto-oncogene)) using European Leukemia net     recommendations the study will be conducted in NCCCR (National Center for Cancer Care &     Research) sample size calculations detailed in the statistic part the clinical hematologist     will recruit the patients this will include consenting process inclusion and exclusion     criteria the molecular pathologist will do the molecular testing the clinical research     coordinator and fellows will do the CRF (Case Report Form) as well as quality of life     questionnaire and applying the protocol for evaluation of cardiac evaluation Molecular     monitoring of BCR-ABL1 transcripts to assess treatment response in CML (Chronic Myeloid     Leukemia).   "
15737|NCT03079492|"     Moderate hypothermia has been demonstrated to be the effective treatment for neonates with     hypoxic-ischemic encephalopathy (HIE). However, few studies reveal the actual alterations in     physiological parameters (i.e. brain temperature and cerebral blood flow) of neonates     undergoing cooling, especially for HIE lesions. Therefore, this project aims to utilize the     magnetic resonance imaging (MRI), i.e. MR thermal imaging and phase contrast MRI to measure     the changes of these parameters before and during hypothermia; and then make comparisons with     the routine nasopharyngeal and rectal temperature. All these would provide in vivo     quantitative data for therapeutic evaluation and promote the optimization.   "
15738|NCT03079479|"     Introduction: Total hip arthroplasty has been increasingly used as a means of treating the     various pathologies of this joint. However, this surgical reconstruction initially brings     important deficits in subjects submitted, such as: inhibition of muscle strength, limitation     of range of motion and functional deficit. Therefore, an immediate physiotherapeutic     treatment is necessary in the short and long term, taking into account both biomechanical     issues and the quality of life of these individuals.      Objective: To evaluate the clinical evolution of individuals submitted to total hip     arthroplasty in the ten year period.      Method: Twenty individuals submitted to unilateral total hip arthroplasty will be evaluated     by the medical group of hip surgeries of the Brotherhood of Santa Casa de Misericórdia of São     Paulo, during a period of ten years. These individuals will undergo a primary clinical     evaluation and after signing the consent form, will be evaluated functionally with the HARRIS     HIP SCORE and WHOQOL-bref questionnaires and physically with the analysis of muscular     strength through manual dynamometry to measure the strength level of the Muscles involved in     the bilateral coxo-femoral joint, such as abductors, adductors, flexors, extensors, internal     rotators, external rotators, knee joint, such as extensors and flexors, and ankle, plantar     flexors. Finally, they will be referred to the kinematic gait analysis, to identify the     functional characteristics of these individuals, through reflexive markers at specific     anatomical points, where they will walk for 5 minutes on a treadmill at a speed of 1.5km per     hour.   "
15739|NCT03079466|"     Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life     domains in patients over 70 years of age with mild-to-moderate OSA      Primary Outcome: Epworth scale and QSQ domains      Secondary Outcomes: Neurocognitive variables and CPAP adherence   "
15740|NCT03079453|"     A prospective randomized clinical trial that included thirty subjects who underwent     tonsillectomy. The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg)     through the uvula and soft palate tissue directly before tonsillectomy. Group 2 (n:15)     patients had tonsillectomy without dexamethasone injection. Patients were examined     preoperatively and postoperative on the first and fifth days. In this study investigators     tried an approach of dexamethasone application to reduce uvula edema after tonsillectomy.   "
15741|NCT03079440|"     GI tract including pancreas is the one of most common primary sites of neuroendocrine tumors.     Current grading of neuroendocrine tumors are based on the 2010 WHO classification. This     classifies grade 3 tumors as the neuroendocrine tumor with mitosis > 20 per 10 high power     field or Ki-67 labeling index > 20%. Etoposide-based chemotherapy, mostly as the combination     with cisplatin, has been the mainstay of the treatment for patients with grade 3     neuroendocrine tumors. However, a recent large retrospective analysis has suggested this     regimen may not be effective in relatively low Ki-67 labeling index. Therefore, the     investigators designed a clinical trial testing temozolomide-capecitabine combination, which     has been mostly investigated in well differentiated (ie., grade 1 or 2) neuroendocrine     tumors, in patients with grade 3 and low Ki-67 gastroenteropancreatic neuroendocrine tumors.   "
15742|NCT03079427|"     There is no proven adjuvant treatment after curative surgical resection in patients with     cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of     adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected     cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal,     adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the     investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine     plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.   "
15743|NCT03079414|"     Sudden cardiac death (SCD) remains a major cause of mortality within developed nations     despite aggressive efforts to reduce its societal burden. Despite extensive clinical and     genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the     potential contribution of additional cardiac conditions that may not be identified with     contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of     invasive electrophysiology study within this patient population.   "
15769|NCT03079076|"     Ultrasound guided thoracolumbar interfascial plane (TLIP) block was first described in 2015     by Hand et al. TLIP block involves injection of local anesthetics between multifidus and     longissimus muscles at the third lumbar vertebra level and can block the dorsal rami of     thoracolumbar nerves. In new approach differently, the investigators made the injection     between longissimus and iliocostalis muscles with a 15 degree angle from medial to lateral.      The aim of this study is to determine effectiveness of ultrasound guided thoracolumbar     interfascial plane (TLIP) block in patients undergoing spinal surgery.   "
15825|NCT03078348|"     The purpose of this research study is to compare a new educational material to another widely     available educational brochure. The goal is to see if the new educational material will     change knowledge and behaviors about colorectal cancer and colorectal screening.   "
15744|NCT03079401|"     Patients under the age of 5, with a diagnosis of hypoplastic left heart syndrome (HLHS),     unbalanced atrioventricular canal (uAVC), or borderline left heart who are undergoing staged     LV recruitment following bidirectional Glenn (BDG) or undergoing BDG with plans for LV     recruitment will be considered for enrollment in this study. Those patients enrolled in the     study will be randomized to either the experimental arm or control arm of the study. Those     patients randomized to the experimental arm will receive mesenchymal precursor cells (MPCs)     injected directly into the LV endocardium during their LV recruitment or BDG procedure. Those     patients randomized to the control arm will receive normal standard of care during their     procedure with no injection of MPCs.      It is believed that injection of MPCs will help improve the chances of those patients with     single ventricle or borderline left ventricle being converted to biventricular circulation     which could improve quality of life and longevity over palliation.   "
15745|NCT03079388|"     Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their     unborn children. Undernutrition during pregnancy can result in maternal complications such as     life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications     such as intrauterine growth retardation, low birth weight, pre-term delivery and poor     cognitive development. Poor women in the developing world are at heightened risk of     malnutrition due to inadequate dietary intake and are subject to transmission of a number of     infections including malaria, intestinal helminths, and genitourinary infections. Food     interventions for malnutrition may be less effective under conditions with excessive     inflammation and infection, and especially so during pregnancy. Without specifically     addressing treatment for infections, undernourished mothers may be less responsive to     nutritional interventions. The benefits of treating both malnutrition and common infections     simultaneously remain largely unstudied. This study tests the hypothesis that malnourished     pregnant women receiving 100 grams per day of a specially formulated ready-to-use     supplementary food in addition to a combination of 5 anti-infective interventions will have     greater weight gain in pregnancy and deliver larger, longer infants than women receiving the     standard of care. The outcome of the pregnancy and maternal nutritional status will be     followed until 6 months after delivery.   "
15772|NCT03079037|"     This study will test the hypothesis that deep brain stimulation (DBS) targeting specific     changes in oscillatory activity at the site of stimulation will prove superior to continuous     isochronal DBS thus providing the rationale for development and optimization of closed loop     paradigms and determine whether the optimal closed-loop biomarker varies across subcortical     targets, is task dependent, or serves to re-establish a default network that removes an     underlying disruptive physiological state leading to greater improvement in motor signs and     task performance.   "
15773|NCT03079024|"     The purpose of this study is to determine whether cognitive training exercises can improve     cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective,     schizophreniform, and psychosis NOS who are being treated in community mental health     settings. The investigators will examine the effects of web-based cognitive training     exercises delivered on a portable laptop computer. The findings will provide valuable     information on whether cognitive training can improve the cognition and functioning of young     individuals early in the course of schizophrenia.   "
15746|NCT03079375|"     Background      It is well known that the transfer of a patient from hospital to the general practitioner is     related with mistakes in the medication of the patient. A report from 2006 measure the number     of drug related admissions in Denmark to be 69.000 to 162.000 per year. To reduce these     mistakes, more and better communication between the health professionals are suggested.     Furthermore medication reviews made by pharmacist seems to reduce the number of drug related     readmissions and other drug related issues, which can lead to an economic cost reduction.      Objective      The aim of this study is to investigate the impact of medication review and better     communication between the health professionals after discharge of a patient from hospital to     the general practitioner. The effect is measured as reducing the number of readmissions and     number of visits at the emergency department 30 days and 6 month after inclusion of the     patient.      Method      This study was estimated to include 1500 participants. The patients were randomized to one of     three groups; usual care, basic intervention or extended intervention. The usual care     received the normal care following the Danish standard procedure. The basic intervention had     a medication review by a clinical pharmacist during admission.      The extended interventions group was similar to the basic intervention group plus follow-up     with the patient, the general practitioner and if relevant the nursing home and pharmacy 1     week and 6 month after discharge by interview with the clinical pharmacist.   "
15747|NCT03079362|"     The study evaluates the anatomical distribution of the assessed Electromyogram (EMG)     responses ensuring after sensory nerve root stimulation and obtained IOM grading during     selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as     well as pain management and outcome data.   "
15748|NCT03079349|"     To test whether the investigator's educational methodology is associated with increasing     learning of participants. The investigators second objective is to test the hypothesis that     learning in an online classroom would result in similar outcomes as the traditional     classroom.   "
15749|NCT03079336|"     Pragmatic randomized controlled trial (expected N = 80) of cognitive-behavioral therapy (CBT)     to contrast two psychotherapeutic implementation strategies (State-of-the-Art welcome phase     vs. prolonged focus on sudden changes). Blinded allocation of implementation strategy for     patients; open label for therapists (no blinding possible), randomized allocation for     patients, therapist allocation via ABAB-design (crossed-therapist design). Post treatment     self-reported outcome will be measured based on a latent outcome factor (i. e. outcome     composite).   "
15750|NCT03079323|"     Prospective non-randomized phase 2 trial to study the efficacy of additional elective     para-aortic RT (PART) in pN1 patients compared to those who were historically treated with     adjuvant whole pelvic radiotherapy (WPRT) alone.   "
15751|NCT03079310|"     Balance and gait impairment increases the risk of falls and contributes to a reduced quality     of life and shorter survival in Parkinson disease (PD) patients. In preliminary case studies,     electrical epidural spinal cord stimulation (SCS) has been shown to significantly improve     gait, postural instability, rigidity, and tremor. Controlled studies for optimizing which     stimulation settings produce the best clinical response for mobility and gait, and achieving     these results chronically are all significant unmet needs. Using quantitative laboratory and     mobile technologies to test a range of stimulation settings, this research study aims to     determine which SCS parameters or combination of parameters is best suited to effectively     alleviate disabling symptoms experienced by each PD patient.   "
15752|NCT03079297|"     This randomized double-blind placebo-controlled crossover study seeks to evaluate the     antidepressant effect of L-leucine, an essential amino acid, in patients with Major     Depressive Disorder (MDD).   "
15753|NCT03079284|"     Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be     enrolled in a new protocol that will allow mothers to hold their infants during the     hypothermia treatment period. This is a safety study that will assess whether or not there is     an increase in adverse event frequency in infants that are held during hypothermia. Parents     and NICU nurses will be given a questionnaire after holding is complete investigating their     feelings on maternal-infant bonding and safety of the holding protocol.   "
15761|NCT03079180|"     Tendons are essential structures for transmitting muscle forces to skeletal structures. A     stiffer tendon will transmit muscle force faster, and then allow faster movement. Moreover,     tendons are a living tissue and respond to mechanical forces by changing their metabolism as     well as their structural and mechanical properties. The aim of the present study is to answer     essential questions remaining unanswered that are necessary in order to optimize physical     activity with ageing in humans, and thus improve quality of life in elderly. The main     questions are: What is the minimal training intensity leading to tendon adaptations? What is     the time-course of tendon adaptations? Does the same loading protocol lead to similar tendon     adaptations for different tendons (Achilles vs Patellar) and does the same training program     lead to identical tendon adaptations with age (25yrs vs 75yrs)? To answer these questions,     tendon architecture and mechanical properties will be investigated in humans of different age     and applying different training intensities. The kinematic of the tendon adaptations due to     these different training characteristics will also be investigated. The training protocol     will be applied on plantar flexors and knee extensors. MRI and ultrasound techniques as well     as the use of ankle and knee ergometers will allow the quantification of possible     modifications in tendon architecture and mechanical properties (tendon stiffness and Young's     Modulus). This will be assessed in vivo, using ultrasound images to assess tendon     displacement during an incremental maximal contraction.   "
15762|NCT03079167|"     Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic     encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in     conjunction with hypothermia in infants with moderate/severe HIE will improve     neurodevelopmental outcomes at 2 years of age, without significant adverse effects, when     compared to hypothermia alone.   "
15763|NCT03079154|"     The study is a three-arm intervention, where students are randomly assigned to one of three     conditions: Teacher-led group-based MBCT, Self-guided MBCT using an audio book, or 'wait     list' control. Pre-intervention, respondents complete a questionnaire assessing self, values,     psychological processes related to self, and well-being. Post-intervention, respondents     complete the same questionnaire, and then take part in a laboratory-based study which     assesses behaviours related to the variables measured in the questionnaires. We are aiming     for a sample size of 180 students at Sussex, 60 in each intervention arm.   "
15764|NCT03079141|"     Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye     disease that is often diagnosed in patients in the professionally active age range. In this     disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and     the retinal pigment epithelium. This specific form of macular degeneration can cause     permanent vision loss, image distortion, and loss of color and contrast vision. An early     diagnosis and treatment may improve the visual outcome and quality of life.      To date there is no international consensus on the optimal treatment of cCSC. Many     retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in     chronic CSC. Treatment with oral eplerenone may also be effective in this disease.      In this proposed prospective randomized controlled trial, cCSC patients will be randomized     into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The     trial is a superiority study, because retrospective studies suggest that PDT treatment may be     more effective than eplerenone treatment.      The null hypothesis of the study is that PDT treatment is more effective than eplerenone     treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is     not superior to eplerenone treatment.      Treatment success will not only be based on characteristics on ophthalmological imaging, but     also on functional endpoints (both on the outcome of questionnaires, best-corrected visual     acuity, and microperimetry), which are most important from a patient's perspective.      The study will take place in 3 large tertiary referral university hospitals in The     Netherlands that have extensive experience with conducting clinical trials (Academic Medical     Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the     Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the     Radboud University Medical Center and the Leiden University Medical Center have been involved     in the first prospective randomized controlled trial that is currently conducted in cCSC.      This study will last 2 years per participant. Each participant will visit the outpatient     clinic for a maximum number of 6 visits.      A total number of 107 patients will be included in the trial. Depending on the speed of     inclusion of patients in this trial, the total duration of this study can be determined.   "
15765|NCT03079128|"     There is a body of evidence that has evaluated the effect of Weight Watchers, a commercially     available weight loss program, on changes in body weight. The current investigation aims to     add to this body of evidence by providing additional data on changes in body weight and     enhance the current evidence-base in regards to evaluating other health-related outcomes.      There is little evidence that demonstrates whether or not the weight loss as a result of the     Weight Watchers program elicits changes in health-related functional outcomes such as aerobic     capacity, flexibility, sleep, and other psychological measures. Additionally, within a     scientific research protocol, measures of adherence and satisfaction will also be evaluated     evaluated. This study will evaluate these outcomes beyond weight changes achieved across the     24-week program.   "
15766|NCT03079115|"     The purpose is to test whether a short-term, high-dose atorvastatin treatment (80mg once a     daily (QD) from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS) is     superior to conventional-dose atorvastatin treatment (20 mg QD from 3 days before to 30 days     after CAS), in terms of efficacy for prevention of periprocedural ischemic brain damage in     Chinese patients undergoing CAS.   "
15767|NCT03079102|"     Phase II double blind (participants and investigator) placebo controlled randomized (1:1)     clinical trial of inhaled nitric oxide (iNO) 20 ppm administered over 12h beginning as soon     as possible but within 4 h of return of spontaneous circulation (ROSC) from out-of-hospital     cardiac arrest (OHCA). Planned enrollment is 130 subjects over 24 months at University of     Pittsburgh Medical Center (UPMC) Presbyterian and UPMC Mercy with randomization stratified in     blocks of 8. Recruitment will be performed under exception from informed consent (EFIC) to     facilitate early enrollment and treatment. The study will have a pre-specified safety     analysis at the mid-point (after 1 year or 60 patients whichever occurs first). Subjects will     be screened by members of the University of Pittsburgh post-cardiac arrest service (PCAS),     all of whom will serve as the study co-investigators, and the Research Coordinators.     Notification of inclusion under EFIC will be performed as soon as possible by a member of the     study team generally to a surrogate as the subjects will be comatose after OHCA.   "
15768|NCT03079089|"     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option     with a significant chance of healing in lymphoid hematological refractory or multiple     relapses after chemotherapy. However, all patients with an indication of allo-HSC can not     benefit because of two limitations: the toxicity of the treatment and graft shortage     available.      For patients refractory or in relapses with an indication of allo-HSC, used the combinaison     of an SET followed by the reduced-intensity allo-HSC (RIC) has shown some interesting     results.      A post-transplant immune modulation with prophylactic injections of donor lymphocytes (PDLI)     showed its effectiveness to decrease the risk of relapse while having a lower toxicity than     chemotherapy   "
15770|NCT03079063|"     The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over     study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with     Novoseven in 24 patients, adult and children (>12 years), not bleeding, with inherited     coagulation factor VII (FVII) deficiency (FVII <1%). Patients will be randomized to receive     either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30     μg/kg, or vice versa, with doses separated by a washout period. All patients will be followed     12 months and will receive biosimilar eptacog alfa, on demand, for every bleeding episode     that should occur - or - for prophylaxis, with the aim of monitoring of inhibiting antibody     formation, lack of efficacy and collection of safety data.      Additional 26 patients with the same inclusions and exclusions criteria will be included in     this study (for a total 50 patients). These patients will not enter the PK phase of the study     but they will be followed to receive biosimilar eptacog alfa, on demand, for every bleeding     episode that should occur during 12 months - or - for prophylaxis, with the aim of monitoring     of inhibiting antibody formation, lack of efficacy and collection of safety data. The     modality of treatment with biosimilar eptacog alfa (on demand or prophylaxis) will be decided     by the Investigator.   "
15771|NCT03079050|"     Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved     drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1.     Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet     needs that may accompany traditional proton pump inhibitors, with two separate pH-depended     release phases, the first in the proximal duodenum and the second in the more distal small     intestine. This dual release system extends the plasma concentration and pharmacodynamics     effects beyond those of single-release PPIs, allowing for dosing at any time of the day     without regard to meals 1. A study conducted by Fass et al. has shown that the use of     dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective     than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and     consequently improving work productivity, sleep quality and quality of life 2.      Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove     beneficial in optimizing the management of GERD and the associated burdens that often surface     after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep     quality.   "
15774|NCT03079011|"     This study is a randomized, open-label, multicentric, phase III trial conducted in patients     receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor     (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset     of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy     (aromatase inhibitor changed to fulvestrant) combined to palbociclib, together with the     safety of hormone therapy and palbociclib combination in the overall population.   "
15775|NCT03078998|"     Juvenile Idiopathic Arthritis (JIA), Cerebral Palsy (CP), and Obstetric Brachial Plexus     Injury (OBPI) are the most common disorders that cause upper extremity impairments in     children. Depending on the underlying pathologies, the common symptoms of these disorders are     the limitations of the upper extremity joint movement angles, muscle imbalance and the     functional limitations caused by the contracture due to these problems. Daily life activities     such as feeding, personal care, and self mobility activities that use upper extremity are     commonly limited with these children. Physical rehabilitation is mostly used to address these     problems. However, the process of rehabilitation is difficult and lengthy. In addition, most     of the time, classical rehabilitation is discouraging for many young patients. Employment of     digital technology has been gaining momentum in addressing the above rehabilitation problems     among the medical professionals.      By utilizing exciting new sensor technologies, such as Microsoft Kinect, Nintendo Wii and     Leap Motion, practical game based rehabilitation applications have been becoming popular.     Video Based Games (VBG) that adopt the these technologies as Human Computer Interaction (HCI)     interfaces are recently used successfully for the task of rehabilitation. The Leap Motion     device, one of the new examples of these technologies, has a very small form factor. It     includes two near infrared stereoscopic cameras to capture hand images of patients to produce     3 Dimensional (3D) positions of hand joints at a very fast rate with a sufficient positional     precision.      There have been examples that use motion sensor based VBG's for the rehabilitation of     different types of patient groups. Compared to classical rehabilitation practices, these     applications provide many advantages such as ease of use, repeatableness, and instantaneous     measurable feedback. In addition, the young patients involved in these applications     demonstrated willingness to participate in these activities and they showed considerable     progress in upper extremity rehabilitation. However, these VBG's were mostly developed for     general public and it was often suggested to develop VBG's for the specific task of upper     extremity rehabilitation of children. It is known that upper extremity specific VBG's and     their applications are very limited both at the global and domestic levels.      With this project, we plan to design and develop specialized Leap Motion based VBG's for the     children diagnosed with JIA, CP, and OBPI. These VBG's will be designed to be easy to use and     motivating for the children. They will automatically lead the patients to correct hand     exercises and they will provide mechanisms for online performance measurements of the     patients. The performance results from the patients will be compared with the results from     the classical rehabilitation applications by the standards of The International     Classification of Functioning (ICF). These games will provide complete Turkish language     support for the extended national dissemination of the project outputs.      The proposed project is inherently a multi disciplinary work that requires very close     interaction of phisiotherapists, software experts, and HCI specialists and efficient     application of the these games for the patients. There will be specialized games for each     disorder. These games will utilize the outputs from the Leap Motion device that will produce     3D hand joint positions and joint angles. Realistic animations of hand and virtual     environments will provide a motivating exercise game platform for the patients.The     performance measurements of the patients will be repeated for each game session. There will     be game parameters for the game duration, difficulty level, and hand joints in focus. The     game hand movements will reflect daily life activities for the rehabilitation purposes which     would make our games different from the general public games. The project findings at end of     the project on best game usage frequency and durations, the effectiveness of the designed     VBG's and other results will be shared with the scientific community through publications and     seminars.   "
15776|NCT03078985|"     The purpose of this clinical study is to assess the safety and performance of the Vision-MR     Ablation Catheter, the primary safety endpoint will measure the rate of serious adverse     events related to the device or procedure; the primary performance endpoint will measure the     acute success rate defined as the demonstration of bidirectional cavo-tricuspid isthmus block     after radiofrequency application in the cavo-tricuspid isthmus; the secondary performance     endpoint will measure the chronic success rate defined as the freedom of recurrence of type 1     atrial flutter at three months post-ablation procedure. The study will be a single center     study conducted at the Leipzig University Hospital Heart Center in Germany. The study     population will consist of adult patients requiring ablation for type I atrial flutter.      This is the follow-up study to NCT02699034.   "
15777|NCT03078972|"     This study will evaluate how the cardiovascular system interacts with mechanical hearts to     provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the     impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2)     to define the primary determinant(s) of exercise capacity in heart failure patients before     and after device implantation.   "
15778|NCT03078959|"     This is an observational retrospective study. The primary objective is to investigate the     expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor     samples from 350 patients with early stage treatment-naive non-small-cell lung cancer     (NSCLC).      Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by     immunohistochemistry using the SP263 antibody. Stained samples will be evaluated     independently by two operators. A tumor will be defined as positive when = or >50% of tumor     cells express the ligand.      The investigators will investigate the relationship between PD-L1 protein expression and     overall survival and other clinical characteristics with appropriate statistical methods.   "
15806|NCT03078595|"     Von Willebrand disease (VWD) is the most common inherent bleeding disorder resulting in     prolonged bleeding time. Gingival bleeding is a frequently reported symptom of VWD. However,     gingival bleeding is also known as a leading symptom of plaque-induced gingivitis and     untreated periodontal disease. Gingival bleeding in VWD patients may be triggered by gingival     inflammation and not a genuine symptom. Thus, this study evaluates whether type 2 and 3 VWD     determines an increased susceptibility to gingival bleeding in response to the oral biofilm.   "
46902|NCT02671695|"     the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on     cardiac iron overload and cardiac functions in multi-transfused children with beta     thalassemia major   "
15779|NCT03078946|"     This randomized double-blind parallel clinical study was conducted on 60 patients undergoing     elective cardiac surgery under general anesthesia, at least 60 yr old, ASA I and II, 70-100     kg body weight and height 160-180 cm. Patients were randomized to: group A=30 patients     receiving dexmedetomidine infusion (0.4- 0.7 µg /kg/h) or group B= 30 patients receiving     morphine in a dose of 10-50μg/kg/hr as an analgesic with midazolam in a dose of 0.05mg/kg up     to 0.2 mg/kg repeated as needed. Titration of the study medications infusions was conducted     to maintain light sedation (RASS) (-2 to +1). Primary outcome was the prevalence of delirium     measured daily via Confusion Assessment Method for intensive care. If Delirium and agitation     occurred: haloperidol 2.5-5 mg IV was given in repeated boluses. Secondary outcomes included     ventilation time, additional sedation/analgesia, hemodynamics and adverse effects.   "
15780|NCT03078933|"     The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot     ulcer wound and the surrounding wound area as it related to wound healing.      The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number     of minutes to deliver the treatment) and frequency (number of days per week to treat) to     determine the most optimal treatment time and frequency to develop a rationale for safety and     efficacy for the final APT001 clinical study.   "
15781|NCT03078920|"     The objective is to investigate the new Naida CROS device in adult recipients including     chronic phases and to generate some preliminary pre-launch data.      The formal study objectives are to compare the speech intelligibility in quiet and noise when     using the CROS device with the Naida CI Q70 processor versus the Naida CI processor alone in     quiet and noise conditions. Subjects will be tested with and without CROS at the baseline     visit and then at follow-up visits taking place one month and three months after baseline.     Subjects will use the new device at home between the first two visits appointments and then     will only use the Naida CI processor for two additional weeks to better evaluate the handicap     of not having access to contralateral signal input. There will be four visits to the centre     in total.      Subjective feedback will be collected through questionnaire like the APHAB and Speech,     Spatial and Qualities of Hearing Scale (SSQ). A customised questionnaire focusing usability     and benefit of the CROS will also be administered.      Additional interest of the study will be to evaluate any acclimatisation effect with the CROS     device both objectively and subjectively.   "
15782|NCT03078907|"     The primary objective of this study is to evaluate the effect of selexipag on the physical     activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using     a wearable wrist device (actigraph). The actigraph will collect data on daily life physical     activity in the patient's real environment. In addition, the PAH symptoms and their impacts     will be assessed by using an electronic patient reported outcome measure in the patient's     real environment. Patients will be assigned randomly to either selexipag or placebo.   "
15816|NCT03078465|"     To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of     adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel     after successful implantation of coronary drug-eluting stents.   "
16534|NCT03069066|"     Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will     assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the     treatment of patients suffering from ISR after scoring balloon pre-dilatation.   "
15783|NCT03078894|"     Tropical diseases are continuously on the rise throughout the world as they are spreading and     manifesting in various locations globally. The more prominent vector tends to be the mosquito     after it bites a previously infected host. The viruses of Zika, Chikungunya, and Dengue are     some of the tropical diseases that are affecting large populations and expanding rapidly.     Developing countries are at the highest risk because of the lack of preventive methods that     are customarily demonstrated in developed countries. Sanitation issues complicate the problem     as contaminated wastewater is ideal for mosquitos to lay eggs. In addition, the organic     material in the wastewater serve as food for larvae. The purpose of this study is to test     bodies of waters in Peru and examine if contaminated water is a contributing factor in the     proportion of the population infected with Zika, Chikanguyna or Dengue.   "
15784|NCT03078881|"     This is a Pre-Phase 1 prospective, non-interventional clinical assessment study to evaluate     Crigler-Najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.   "
15785|NCT03078868|"     To determine whether DW-MRI is applicable in the evaluation of post-operative collections,     and whether utilization of DW-MRI can enhance application of percutaneous drainage and     prevent unnecessary drainage.   "
15786|NCT03078855|"     Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable     outcomes in patients with numerous cancers, there has never been a thorough study of vitamin     D treatment in subjects undergoing treatment for cancer. The purpose of this study is to     evaluate whether modification of vitamin D levels in the blood, through supplementation, can     improve outcomes.   "
15787|NCT03078842|"     Diarrhoea continues to be a major cause of child deaths. Current treatment of acute watery     diarrhoea includes oral rehydration solution (ORS), zinc and continued feeding. The use of     zinc is based on a number of studies that showed that zinc reduces the duration and severity     of diarrhoea. The recommended dose of zinc in 6-59 month old children is 20mg/day for 10-14     days. This dose is associated with an increased risk of vomiting. No dosing studies are     available to determine the optimal dose of zinc, which while maintaining the benefits also     has a low risk of vomiting.      The investigators will conduct a double-blind randomized controlled trial of three doses of     zinc (20mg/day, 10mg/day and 5mg/day) in two settings - one in Sub-Saharan Africa and the     other in South Asia. The study population will be 4500 children with diarrhoea of less than     72 hours duration who are aged 6-59 months. They will be recruited from outpatient and     inpatient health facilities. All enrolled children will receive ORS and continued feeding as     recommended by the World Health Organization. Those allocated to the standard zinc dose will     receive an oral dispersible tablet with 20mg zinc daily for 14 days. Those allocated to lower     dose zinc will receive identical tablets with either 10mg or 5mg zinc daily for 14 days.     Enrolled children will be followed by until recovery from diarrhoea or 15 days after     enrolment, whichever is later. In addition, study children will be assessed again at thirty     (30), forty-five (45), and sixty (60) days to estimate impact on post illness outcomes.     Primary outcomes will be mean duration of diarrhoea, proportion of episodes that last longer     than 5 days, mean number of stools and proportion of children with vomiting.   "
15807|NCT03078582|"     The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with     Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients in the study:     the first group will include patients who have never received eculizumab for treatment of     PNH. The second group will include patients who have received treatment with eculizumab for     at least 6 months prior to the study. Patients will be treated with RA101495 for 12 weeks.   "
15788|NCT03078829|"     Background: The QT interval of the electrocardiogram (ECG), corrected for heart rate (QTc),     is a measure of the duration of ventricular repolarization and is a widely used marker of     ventricular arrhythmia risk. Testosterone has a shortening effect on QTc length, and the QTc     interval in males is shorter than in females after the onset of puberty. Transgender female     adolescents are treated with GnRH agonists or spironolactone that suppress endogenous     testosterone secretion and might increase the QT interval sufficiently to increase the risk     for malignant ventricular arrhythmias. There are no current guidelines regarding monitoring     QTc interval in transgender females undergoing GnRH agonist treatment.      Objective: To assess the effect of GnRH agonist treatment on QTc interval in transfemale     youth.      Methods: A quasi-experimental time series study of transgender female adolescent, seen at     UCSF Child and Adolescent Gender Center (CAGC) during 2017-2019.      Specific aims:      To assess the impact of GnRH agonist treatment on QTc interval length in transgender female     adolescent   "
15789|NCT03078816|"     Dystonia is a movement disorder seen in both children and adults that is characterized by     sustained or intermittent muscle contractions causing abnormal, often repetitive, movements,     postures, or both. Secondary dystonia is far more common in pediatric populations than     primary dystonia, and far more recalcitrant to standard pharmacologic and surgical treatments     including Deep Brain Stimulation (DBS). There exists a large unmet need to develop new     therapeutics, treatment strategies, and outcome measures for pediatric secondary dystonia.      The investigators are proposing to investigate the ventralis oralis posterior nucleus (Vop)     of the thalamus as a new target for DBS in secondary dystonia. Prior to the development of     DBS, the main surgical treatment of dystonia was thalamotomy. Although there were many     different targets in the thalamus, often done in staged procedures, the most common and     successful targeted nuclei was the Vop, which is traditionally thought to be the pallidal     receiving area. Previous lesioning of Vop produced improvements in dystonia but intolerable     side effects, especially when implanted bilaterally. However, given that secondary dystonia     patients were often reported to have superior results to primary dystonia it is reasonable to     believe that if the side effects can be modulated, that targeting of the Vop nucleus with DBS     could be a viable alternative to Globus Pallidus interna (GPi). Given that Deep Brain     Stimulation is a treatment that is inherently adjustable, it is conceivable that settings on     the Deep Brain Stimulation could be adjusted to allow for clinical benefit with minimal side     effects. Indeed, there have been several scattered successful case reports attesting to this     possibility.   "
15790|NCT03078803|"     To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and     endoscopic response in patients with mild to moderate Crohn's disease   "
19670|NCT03028103|"     This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to     characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID     continuously in 28-day cycles in both study parts.   "
15791|NCT03078790|"     Preoperative anxiety is a common occurrence for many patients undergoing all types of     surgery. Patients with a high level of anxiety before surgery have been shown to have     numerous negative outcomes both intra-operatively and post-operatively. Many studies have     shown that preoperative psychological interventions that aim to reduce anxiety also result in     improved post-operative behavioral and clinical recovery. Currently, the most common method     to treat preoperative anxiety is the administration of a prescription benzodiazepine.     However, there is limited clinical evidence that supports the use of sedative premedication,     such as with a benzodiazepine, before surgery. Complementary integrative medical therapies     including music, massage, guided imagery, and deep breathing have been proposed to minimize     stress and pain in surgical patients. These therapies are thought to be effective by evoking     the relaxation response through stimulation of the parasympathetic nervous system and     engagement of the patient in the healing process. Relaxation and deep breathing,     particularly, have been shown to reduce pain, anxiety, and tension-anxiety in hospitalized     patients. Based on this evidence, a guided paced deep breathing module has been proposed to     reduce preoperative anxiety in patients undergoing gynecological surgery at Mayo Clinic     Rochester Methodist Hospital. In this study, patients' anxiety will be assessed     pre-intervention on a 0-10 numeric rating scale, as well as post-intervention and a paired     t-test will be used to assess effectiveness. Additionally, qualitative questions will be     administered via a questionnaire post-intervention to gain more insight on the effectiveness     of the intervention. The feasibility of the intervention in the busy preoperative setting     will be evaluated by assessing how many times a patient is interrupted while participating in     the paced deep breathing module. If this module is found to be effective in reducing     patients' anxiety, it will be implemented into practice so that every patient undergoing     gynecological surgery, at the institution, will be offered the module preoperatively.   "
15792|NCT03078777|"     We recently completed and published a study that demonstrated that fexofenadine     pharmacokinetics are significantly altered in dialysis patients (Thomson et al. (2015)     American Journal of Kidney Diseases 65(4):574-582). In this study, patients were studied     directly before they were to undergo their routine dialysis treatment. Other published     literature suggests the timing of the dose of some drugs (before or after dialysis) may have     a profound impact on the drug pharmacokinetics (Nolin et al (2006) 17(9):2363-7). The     hypothesis is that compounds that accumulate in the blood of patients with kidney failure     impact the pharmacokinetics such that dosing before or after dialysis produces significantly     different blood levels of the drug.   "
15793|NCT03078764|"     This project explores the feasibility of using automated telephone calls to adult patients     with type 2 diabetes to improve diabetes self-management in Thailand. This line of work could     significantly extend Thai nurses' ability to manage this growing epidemic, and ultimately     reduce the suffering and costs caused by diabetes in Thailand.   "
15795|NCT03078738|"     The aim of this first-in-human study is to assess the safety, tolerability, PK and     exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in     healthy male subjects to support further clinical development of OMT-28 in the indication of     atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide     dosing for Phase II trials.   "
15796|NCT03078725|"     A pragmatic, comparative effectiveness trial of glyburide versus metformin.   "
15808|NCT03078569|"     This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to     enhance ovarian response in poor responders.      a randomized controlled trial with two groups, treatment group with transdermal testosterone     before IVF treatment and a control group with no treatment.   "
15851|NCT03077997|"     Diabetes distress is a psychological phenomenon associated with the self-management of the     disease and is characterised by feelings of anxiety, guilt, helplessness, defeat, and     depression. Research suggests that internet-delivered interventions have the potential to     increase people's ability to self-manage their symptoms, but whether they are effective is     largely unknown. This study is designed to investigate the potential effectiveness of an     internet-delivered intervention for diabetes distress in patients with type 2 diabetes.   "
15797|NCT03078712|"     Septic shock is a highly lethal condition associated with a mortality risk of 30 to 60%.     Optimizing tissue perfusion and oxygenation is the aim to decrease mortality and morbidity in     septic shock patients.      Persistent hyperlactatemia after initial resuscitation is particularly difficult to     interpret, although optimizing systemic blood flow might reverse ongoing hypoperfusion.     Nevertheless, if persistent hyperlactatemia is caused by non-hypoperfusion-related     mechanisms, then sustained efforts aimed at increasing cardiac output (CO) could lead to     detrimental effects of excessive fluids or inotropes. Another potential alternative     resuscitation target is peripheral perfusion as assessed by capillary refill time (CRT),     mottling score or central-to-toe temperature differences. Reversal of abnormal peripheral     perfusion might represent improvement in tissue hypoperfusion with the advantage of a faster     recovery than lactate.      Hypothesis: Peripheral perfusion guided resuscitation in septic shock is associated with     lower mortality, less organ dysfunctions, less mechanical ventilation (MV), less vasopressor     load, and less renal replacement therapies than a lactate-targeted resuscitation strategy.      Main Objective To test if peripheral perfusion targeted resuscitation in septic shock is     associated with lower 28-day mortality than a lactate targeted resuscitation.      Design: Multicenter, Parallel Assignment randomized controlled study, conducted under     supervision of an independent Data Safety Monitoring Board (DSMB).      Interventions:        1. Active Comparator- Peripheral Perfusion guided resuscitation        2. Active Comparator- Lactate guided resuscitation      Randomization: 1:1 the randomization using a block size of eight will be stratified according     to participating centers.      Trial size: 400 randomized patients in 30 ICUs.   "
15798|NCT03078699|"     For patients with unresectable or recurrent disease, radiation is routinely administered,     often in combination with systemic chemotherapy. However, because of wide range of radiation,     more complications of conventional radiotherapy limit its treatment dose. The local     recurrence rates of conventional radiotherapy are dissatisfied.Stereotactic body radiation     therapy(SBRT) well solved the problem above. On the one hand, by improving the single dose,     it not only shortens the total radiation treatment, but also increases the total dose of     equivalent biological effects.   "
15799|NCT03078686|"     The primary objective of this study is to evaluate the safety and efficacy of the use of a     biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction (AD-tSVF)     and high density platelet-rich plasma concentrate (HD- PRP). Additionally, comparison with     clinical outcomes of adipose-derived cellular Stromal Vascular Fraction (AD-cSVF) + AD-tSVF +     HD PRP; AD-cSVF + emulsified AD-tSVF + HD- PRP; emulsified AD-tSVF + HD PRP + AD-cSVF;     AD-cSVF via intravenous infusion in treatment of Scaring Alopecias and Alopecia Areata.     Control will be served by use of established clinical protocol of using platelet concentrates     with Matristem Matrix (Acel) injected in the same fashion as the other ARMs within this     study, and comparative analyses performed at the endpoint of this study.   "
15800|NCT03078673|"     Will motor skill- and/or strength training affect technique, work economy and time     performance in cross-country poling? Competitive cross-country skiers (age 16- 30) will     perform a 10 weeks training intervention. They will be randomized in one of the following     three groups: poling specific motor skill training 3 times per week in addition to their     regular training, maximal strength training 3 times per week in addition to their regular     training and a control group who only perform their regular training. Pre- and post     intervention, all participants will perform tests in VO2max (running), VO2max (poling), work     economy (poling), video and inertial measurement unit (IMU) analyzes of poling technique,     time performance test (poling), motor skill tests and maximal strength tests.   "
15801|NCT03078660|"     An innovative nutritional application (App) entitled MyNutriCart was developed to create a     list of foods and beverages to help individuals make smart and healthy choices when     purchasing foods at grocery stores based on the Dietary Guidelines for Americans. This App     was tested in a pilot trial to evaluate its feasibility, usability, and acceptability for     making smart and healthy choices when purchasing food in grocery stores and test its     effectiveness in improving food selection, dietary patterns, and weight status compared with     the traditional nutritional counseling.   "
15802|NCT03078647|"     Clinical Study to Evaluate the Performance of the Profound System for the Treatment of     Cellulite.   "
15803|NCT03078634|"     Randomised controlled trial comparing standard outpatient clinic treatment with     multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will     be followed up to end of clinic treatment and 12 months beyond the end of treatment.     Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be     assessed.   "
15804|NCT03078621|"     This study is a single arm, single center trial to study the safety and efficacy of purified     autologous bone marrow derived stem cells and mesenchymal stem cells for the treatment of     children with cerebral palsy.   "
15805|NCT03078608|"     A cancer diagnosis is extremely stressful, emotionally challenging, and often life-altering     for both patients and their loved ones. Although more than one-third of patients experience     distress, doctors are typically at a loss as to how to help patients and their families     manage these emotional challenges. Mindfulness-based programs, including meditation, are     offered at major medical centers in the US and have been found to help reduce stress and     improve quality of life among cancer patients. However, these classes often require 30+ hours     of in-person instruction over 8 weeks, which is neither practical nor feasible for patients     undergoing chemotherapy due to side effects and scheduling conflicts.      This study will test whether an 8-week mobile app-based mindfulness program is accepted and     useful for patients who have recently received chemotherapy and their loved ones. It will     also test whether it is feasible to randomize participants into three groups: intervention,     active control (receiving progressive muscle relaxation through the same app) and a wait list     control group (will receive the meditation intervention 8 weeks later), so that a future     study can test whether mindfulness intervention can help reduce stress and improve quality of     life. Because many Americans own smartphone or tablet, an app that can teach stress reduction     techniques at home or at infusion clinics has great potential to address emotional needs that     providers often cannot.      The study will also include caregivers of patients who have recently received chemotherapy as     research has shown that caregivers tend to show high levels of stress and depression and     worse physical health compared to non-caregivers. The negative effects of caregiving are most     pronounced in caregivers of patients with cancer. However, little support is directed to     caregivers as most medical attention goes toward the patients. The patient-caregiver     relationship may serve as a source of mutual support and a surrogate for community, which is     traditionally considered to be an essential ingredient for sustaining mindfulness practices.      If this study is successful, it will justify a larger trial to determine if use of a     mindfulness app is effective in reducing stress and improving quality of life for cancer     patients and caregivers. If effective, this low-cost stress reduction strategy could be     distributed and used for all types and stages of cancer patients and their caregivers,     anywhere, any time, helping to improve the quality of life of the many individuals affected     by cancer.   "
24956|NCT02959021|"     The purpose of this study is to examine whether a primary care weight management intervention     delivered by peer coaches produces greater weight loss than a self-directed program without     peer coach support.   "
15809|NCT03078556|"     This study aims to compare the bioequivalence of two experimental fixed dose combination     (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in     healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will     be open label, up to 3 periods design with a wash out period of at least 7 days between     treatment periods. Subjects will be randomized to receive either single entities or     formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16     subjects who complete the first two treatment periods and consent to continue will receive a     single dose of FDC formulation 1 tablet administered with a high fat meal for a third     treatment period. In Part 2 of the study, subjects will be randomized to receive either     single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods.     Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat     meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the     last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the     study and if Part 2 of the study is conducted, another 76 healthy subjects will be included.     The total duration will be approximately 11 weeks.   "
15810|NCT03078543|"     The ANTHEM™ Total Knee System is being conducted to demonstrate non-inferiority of 10 year     implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis     compared to reported literature   "
15811|NCT03078530|"     The overall objective is to determine whether Visbiome will improve        1. intestinal symptoms of Irritable Bowel Syndrome (IBS) and        2. non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache)          associated with IBS. All of these symptoms are part of the Gulf War (GW) illness.   "
15812|NCT03078517|"     Investigators aim to compare two supraglottic airway devices; the i-gel and the newly     developed laryngeal mask airway protector in terms of airway sealing effect, the insertion     success rate, and the incidence of complications in anesthetized patients.   "
15813|NCT03078504|"     Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood     flow rates in critically ill patients receiving continuous renal replacement therapy.   "
15814|NCT03078491|"     This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by     a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of     older patients with T1D. The DMP includes an automated data transfer from CGM,     insulin-delivery devices, and activity tracker to a clinical decision support system (CDS)     that provides dosing adjustment recommendations based on that data to the healthcare team. In     addition, the DMP includes on-demand education for patients and caregivers, and an interface     for communication between providers, patients, and their caregivers.   "
15817|NCT03078452|"     Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling     have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed.     This technology, using a battery-powered drill to operate the needle accessing the posterior     iliac bone, was approved by the Food and Drug Administration (FDA) and is currently     commercially available.      Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone     marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow     sampling. This research study is designed to evaluate the effectiveness of the Jamshidi     needle compared to the battery-powered bone marrow biopsy system.      100 participants will be enrolled in this study at Emory University.   "
15818|NCT03078439|"     Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study     implemented to improve our knowledge of the outcome of preterm children in France. This study     was launched on March 28, 2011 and includes three groups of preterm children, all born before     35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation),     very preterm children (born between 27 and 31 completed weeks) and moderately preterm     children (born between 32 and 34 completed weeks).      These children are being studied from their birth up to the age of 12 years. At birth, data     on maternal and infants' characteristics were collected from medical records. At one and two     years, questionnaires sent to families and to physicians (at two years only) allowed to     collect data about the children's life and health.      At five and a half years, medical and psychological assessments are specifically implemented     for the study in order to evaluate motor and cognitive disorders in this population.   "
15819|NCT03078426|"     High resolution computed tomography (HRCT) plays a major role in the management of idiopathic     pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial     pneumonia (UIP). Though HRCT is the standard reference to describe pulmonary structural     alterations using a non invasive technique, it is nonetheless a radiating exam which provides     limited functional information regarding inflammation. In this trial, the investigators aimed     to evaluate whether MRI (Magnetic Resonance Imaging) using ultra-short echotime could be an     alternative to HRCT in the assessment of the four morphological criteria required to define     an UIP pattern. The investigators also planned to study the clinical value of the additional     informations derived from MRI such as contrasts and lung perfusion using functional MRI.   "
15820|NCT03078413|"     The investigators proposed to review the exercise tolerance, cardiac function, and quality of     life in patients born with transposition of the great arteries that have undergone surgery     with either the Mustard or Senning procedure. Participants will complete a questionnaire. The     investigators will review the participants' recent cardiac function testing which will assess     their current health status. These tests include an echocardiogram, a metabolic exercise     stress test, cardiac imaging, and a 24-hour Holter monitor. This collection of testing     results will be compared specifically with previously acquired data during the first phases     of this study (published in 2001 and 2007).   "
31522|NCT02873169|"     Determination of risk factors of ventricular arrhythmias (VAs) after implantation of     continuous flow left ventricular assist device in order to characterize which patient     requires ICD implantation in primary prevention.   "
15826|NCT03078335|"     Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is     not related to their delivery but to the hospital environment. Preventing these infections     results in shorter hospital stays for babies, less risk of long term health problems and less     health care resources required to care for them. Hand washing alone doesn't remove all     bacteria from the hands of healthcare workers, and studies have shown that infections in     adults and children admitted to hospital decrease if health care providers use clean, non-     sterile gloves when treating patients. The main focus of this study will be to find out if     using gloves when caring for newborns in the NICU is better than washing hands alone.     McMaster Children's Hospital and The Hospital for Sick Children will be the pilot sites to     participate in a future larger study where some infants will be cared for using non-sterile     gloves, and others will be cared for using the standard hand washing method.   "
15827|NCT03078322|"     The study will evaluate the safety and efficacy of AV-101.   "
15828|NCT03078309|"     Medical Marijuana is used widely, and its effects on the visual system and the function of     the retina have not been investigated thoroughly. Some evidence suggests that cannabinoids     may be beneficial in certain degenerative diseases of the retina.      The purpose of the study is        1. To determine whether cannabis derivatives affect the visual functions in healthy adults        2. To examine the effect of cannabis derivatives on the retina of retinitis pigmentosa          patients   "
15829|NCT03078296|"     This study seeks to determine the burnout rate among minimally invasive gynecologic surgeons     (MIGS) as well as to evaluate other personal, professional, and psychosocial factors     associated with this condition.      An anonymous electronic survey will be sent to the American Association of Gynecologic     Laparoscopists (AAGL) members. The survey will contain items that will inquire about     socioeconomic background, professional characteristic, and about physical and psychologic     well-being.   "
15839|NCT03078166|"     Heart failure (HF) is a major health problem worldwide but there is no global HF study that     documents demographics, socioeconomic and clinical factors, diagnostic and management     patterns, etiology, biomarkers, co-morbidities, treatments, quality of life, barriers to care     and outcomes in all parts of the world. Such knowledge is essential in the prevention and     treatment of this global disease. The Global Congestive Heart Failure Registry (G-CHF) is a     global registry of approximately 20,000-25,000 HF patients enrolled over approximately 5     years to study these risks and causes of HF.   "
15840|NCT03078153|"     The purpose of this study is to determine if social media support and financial incentives     improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24     living in the Washington, DC area who are at high risk for HIV acquisition.   "
15841|NCT03078140|"     Pregnant women who attend at our antenatal clinic will random to 2 groups. First will receive     routine iodine supplementation. The other will receive iodinated pill or only iron     supplementation base on their urine iodine status.   "
15842|NCT03078114|"     The purpose of this study is to examine the change of nervous system activity before and     after spinal manipulation treatment program in people with low back pain.   "
15843|NCT03078101|"     This study will be a prospective, clinical pilot study in CKD patients to show whether     Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared     to ACEi treatment alone.      Null and alternative hypotheses:      H0: Empagliflozin in addition to ACEi treatment does not increase Ang 1-7 levels more than     ACEi treatment alone.      H1: Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels     compared to ACEi treatment alone      Methodology:      Two groups of 24 chronic kidney disease (CKD) patients, respectively, with and without type 2     diabetes will be randomized into the study medication or placebo group. The number of     patients per treatment arms is n = 12. Included and consented patients will be subjected to     an initial 2-week run-in period for conversion of current RAS blocking medications to ACEi     therapy with enalapril or ramipril and respective dose titration to 10 mg enalapril 2 x daily     and 10 mg ramipril 1 x daily. Additional antihypertensive medication will be standardized as     feasible, with the primary goal of keeping blood pressure as recommended by KDIGO. Following     the 2-week run-in phase, all study patients will be subjected to blood collection including     the first RAS quantification (RAS Fingerprint) and assessment of HDL composition, as well as     urinary analysis and bioimpedance fluid status assessment (BCM measurement). Subsequently,     patients will be randomized to either receive empagliflozin (at a dose of 10 mg daily) or     placebo. Subsequently, biweekly study visits including electrolyte and glucose (plasma and     urine) monitoring as well as BCM measurement will take place. After 12 weeks of study     medication intake, a concluding study visit will be scheduled for final RAS quantification     (RAS Fingerprint) and HDL analyses as well as final blood and urinary analysis and BCM     measurement. Initially, blood and urine will be collected at the clinical visit as part of     the routine blood obtainment (no additional effort on patients). From these routine     measurements we will be able to extract information regarding the patient's current CKD stage     as well as other relevant laboratory parameters (e.g. HbA1c, UACR, etc.). Furthermore, we     will document the patient's current medication and significant comorbidities.      Primary analysis variable/endpoint:      The difference of Ang 1-7 increase from baseline between a 3-month treatment with     empagliflozin on top of ACEi treatment compared to ACEi treatment alone      Most important secondary analysis variables/endpoints:        1. Simultaneous quantitative changes of multiple RAS effector angiotensin levels determined          by mass-spectrometry        2. Recurrence of Ang II levels determined by mass-spectrometry        3. HDL parameters (protein composition of HDL)        4. Renal parameters (albuminuria reduction measured by urinary albumin-creatinine ratio          (UACR), renal function (estimated glomerular filtration rate (GFR), serum-creatinine)        5. Urinary electrolyte levels        6. Urinary glucose levels        7. Urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity)        8. Blood pressure determined by ambulatory blood pressure measurements        9. Body volume determined by bioimpedance fluid status assessment (BCM measurement)       10. OCR and ECAR in PBMCs determined by Seahorse Flux Analyzer       11. Assessment of reduction of salt sensitivity by using salt sensitivity test with          empagliflozin   "
15830|NCT03078283|"     This is a small-scale study of the effects on microbes in the human gut of adding high-fiber     snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc.     Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the     study. They will complete 3 successive experiments in which their regular diet is     supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment     will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one     week consuming one snack food per day (approximately 7 g fiber, collection of all fecal     samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber,     collection of all fecal samples), (iv) four weeks consuming three snack foods per day     (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only     regular diet (weekly collection of fecal sample). For each experiment, participants will also     provide a fasting blood sample during the free diet phase at the end of the week just before     initiation of snack consumption, and a fasting blood sample at the end of the last week of     snack consumption. Participants will also collect one first morning urine sample weekly     throughout the study. During week 2, participants will also collect first morning urine     samples for 3 consecutive days. Similarly, they will collect first morning urine samples for     the last 3 consecutive days of the last week of snack consumption. The study will test the     effects of the different fiber-rich snacks on the composition and metabolic properties of the     gut microbial community in lean and obese subjects.   "
15831|NCT03078270|"     The goal of this study is to see whether Botox is an effective treatment for social anxiety     disorder (SAD). Participants will complete two short surveys on depression and anxiety     symptoms, receive a one-time injection of Botox, and complete the depression and anxiety     survey 4 weeks after injection and again at 8 weeks after injection.   "
15832|NCT03078257|"     Antiplatelet treatment is important for coronary artery disease(CAD) patients .Some patients     are resistant to antiplatelet treatment based on platelet function tests(PFT).Currently the     results of PFT are mainly based on the analysis of peripheral blood. instead, adverse     cardiovascular events in CAD patients may be more directly related to platelet activities in     the coronary arteries. There's no evidence of system study to prove the PFT of peripheral     blood can represent the platelet functions in coronary arteries.The purpose of this study is     to determine the different platelet activities in the blood of peripheral vein (PV),     peripheral artery (PA), intracoronary artery (IC) in the CAD patients without or with     different interventions.      our study is divided into three parts: Part A: To study the different platelet activities in     the blood of PV, PA, IC in the CAD patients with dual antiplatelet therapy.      Part B: To explore the different platelet activities of the above three sites in ST-segment     elevation myocardial infarction (STEMI) patients who are administrated platelet membrane     glycoprotein Ⅱb/Ⅲa (GPⅡb/Ⅲa) receptor antagonist ( tirofiban ) in PV or IC and dual     antiplatelet therapy.      Part C: To explore the different platelet activities of the above three sites in STEMI     patients who are administrated antiplatelet thrombolysin or placebo in PV and dual     antiplatelet therapy.   "
15833|NCT03078244|"     Project aims to determine the number of individuals with treatment resistant hypertension and     to define the characteristics of these patients and estimate disease frequency. The study     will be a retrospective review of medical record data based upon de‐identified information     and will require no patient contact.   "
15834|NCT03078231|"     More than 29 million people in the US are living with diabetes, many of whom will develop     diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and     blindness in working-age adults. Annual eye screening is recommended for all diabetic     patients since vision loss can be prevented with laser photocoagulation and anti-VEGF     injections if DR is diagnosed in its early stages. Currently, the number of clinical     personnel trained for DR screening is orders of magnitude smaller than that needed to screen     the large, growing diabetic population. Therefore, to meet this large unmet need for DR     screening, a fully-automated computerized DR screening system is necessary. This study is     designed to assess the performance of EyeArt, an automated DR screening tool.   "
15835|NCT03078218|"     Persistant hypoxemia in the newborn confers, even isolated, an abnormal clinical situation,     that needs to be addressed for an adequate diagnosis and an optimal treatment.      If during the first hours of life, hypoxemia is frequent and often transient, beyond that, it     is necessary to search the various etiological conditions such as a critical congenital heart     disease (CCHD) or a non cardiac affection (sepsis, anemia, respiratory disease).      Newborn pulse oximetry screening identifies babies with critical congenital heart disease     (CCHD) based on the rational that they frequently have a degree of hypoxemia that may be     clinically undetectable. CCHDs are life-threatening forms of congenital heart disease (CHD)     occuring in 2-3/1000 live births but accounting for 3%-7.5% of infant deaths.      Early detection is beneficial because of acute collapse, if not resulting in death, is     associated with a worse surgical and neurodevelopmental outcome.      Currently, screening for CCHD involves antenatal ultrasound scanning and post-natal physical     examination. Although antenatal detection rates have improved over recent years and can be as     high as 70%-80% in some centers, this is not consistent. Indeed, in Nouvelle Aquitaine     overall <50% of CCHDs are detected before birth. In addition, up to a third of infants with     CCHD may be missed on post-natal examination. Pulse oximetry screening can help to close the     diagnostic gap' that is, increase the detection of babies who slip through the current     screening net.      Several large European studies and a subsequent meta-analysis have shown that pulse oximetry     screening is a highly specific (99.9%) and moderately sensitive (76.5%) test which increases     CCHD detection rates. The high specificity results in a low false-positive rate 0.05% to     0.5%. But those babies with a Positive Test, if they may not have CCHD, they may be diagnosed     with other causes of hypoxemia (congenital pneumonia, sepsis, persistent pulmonary     hypertension,...). As with CCHD, delayed recognition of these conditions can result in     postnatal collapse and significant morbidity and mortality. It is also more useful to     consider these conditions as secondary targets of screening and to remember they constitute     30%-70% of false positives. In 2011, the US Health and Human Services Secretary recommended     that pulse oximetry screening for CCHD be added to the Recommended Uniform Screening Panel.     In Europe, implementation is advanced in such countries as North European Countries, and     Switzerland. There isn't yet any European guidance. In France, the implementation is limited     to local and transient experiments. The feasibility, usefulness and cost-effectiveness of     routine pulse oximetry screening have not been evaluated so far. The French setting has two     specificities : 1/ the antenatal detection rate is considered to be rather high. 2/ in     contrast to a lot of other European countries, early discharge from the maternity ward before     48 hours of life is not common, decreasing the risk of discharging a baby with undiagnosed     CCHD, but not saving babies from collapse.      - The Investigators hypothesis is that routine pulse oximetry screening in asymptomatic     newborns would allow to reduce the incidence of complications related to CCHDs as well as     those related to non cardiac pathologies for a reasonable cost for the French Health Care     System.   "
15897|NCT03077399|"     Development and clinical validation of SCALA, a new rating scale for lateropulsion after     stroke. A monocentric controlled study including 60 patients post-stroke and 40 patients     without stroke and/or healthy volunteers..      In order to analyze the SCALA's content validity, a Delphi-type consensus process will be     applied prior to clinical validation. The Delphi process, including 20 international experts,     will give rise to the version of the scale to be tested clinically.   "
15836|NCT03078205|"     Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on     women with ART Failure; to compare the curative effect of the dual therapy and triple therapy     on women with ART Failure; to choose the best TCM interventional therapeutic plan.      Methods: The cases with ART Failure from West China second University Hospital of Sichuan     University (West China Women's and Children's Hospital of Sichuan University) meeting the     inclusion criteria were randomly divided into three groups: the dual therapy group, the     triple therapy group and the control group, compare the natural pregnancy number, the     condition during the period of secondary IVF-ET and the improvement of the kidney deficiency,     liver depression and blood stasis syndrome among those three groups.   "
15837|NCT03078192|"     This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging     conventional proton MRI technqiues for imaging lung structure and perfusion. Specifically,     the 129Xe MRI scans will provide 3D images of ventilation and gas exchange, and spectroscopic     indices will be evaluated to test gas exchange dynamics with high temporal resolution. The     conventional 1H MRI scans will include a free-breathing ultra-short echo time (UTE) scan that     provides images similar to that of a CT scan. In addition, to characterize perfusion and     vascular dimensions directly, patients will undergo a gadolinium-enhanced perfusion scan.   "
15838|NCT03078179|"     The objective of this study is to determine if the presence of bacterias with probiotic     characteristics (Lactobacillus rhamnosus GG and Bifidobacterium longum) in a commercial milk,     control some measures that indicate cariogenic processes.   "
15844|NCT03078088|"     The study will be a randomized, cross-over study of THAM followed by saline or saline     followed by THAM in human non-CF and CF subjects to assess nasal colonization   "
15845|NCT03078075|"     This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy     of extended-release naltrexone plus bupropion as a combination pharmacotherapy for     methamphetamine use disorder. Participants will be randomly assigned to the active medication     combination (AMC) group or matching placebo group and will receive medications over the     course of 12 weeks. Follow-ups will occur in weeks 13 and 16.   "
15846|NCT03078062|"     The purpose of this study is to assess the effect of a single-dose of intravenous     dexamethasone 8 mg on the duration of sensory and motor blockade following spinal anesthesia     with isobaric bupivacaine.      The hypothesis of the study is that intravenous dexamethasone will significantly prolong (by     more than 20 minutes) the duration of spinal anesthesia.   "
15847|NCT03078049|"     Rationale: In order to compare the real-world use of commonly prescribed second-line oral     diabetes therapies, real-world data comparing patients receiving treatment with dapagliflozin     vs sitagliptin are needed, and limited resource use and cost data exist for patients     initiating dapagliflozin in the real-world setting.      Objectives:      Primary: The primary objective of this study is to compare real-world health care resource     utilization and costs following treatment with dapagliflozin versus sitagliptin. Secondary:     The secondary objectives of this study are to assess clinical outcomes and treatment patterns     among patients receiving treatment with dapagliflozin versus sitagliptin. Study Design:     Retrospective cohort study. Target Subject Population: Patients receiving treatment with     either dapagliflozin or sitagliptin will be evaluated.      Study Variable(s):      Primary Variables: Health care resource utilization and costs Secondary Variables:     Demographics measured at the index date, Quan-Charlson Comorbidity score, measured during the     baseline period, Agency for Healthcare Research and Quality (AHRQ)-based comorbidity     measures, receipt of other antidiabetic medication classes during the baseline and follow-up     periods, number and percentage of patients with a diagnosis of obesity during the baseline or     follow-up periods, treatment patterns during the follow-up period (i.e., index dose, duration     of treatment, discontinuation, adherence, receipt of additional antidiabetic medication     classes), HbA1c outcomes (among subgroup of patients with linked laboratory data, sample size     permitting), renal impairment, hypoglycemia as defined by a claims-based algorithm.      Statistical Methods: Initial analyses will be descriptive in nature and entail the tabular     display of mean values, medians, ranges, and standard deviations of continuous variables of     interest (e.g., patient age) and frequency distributions for categorical variables (e.g.,     sex, geographic location). Outcomes will be compared between patients receiving dapagliflozin     versus sitagliptin using univariate tests. Propensity score matching will be undertaken to     reduce bias in the comparison of patients receiving treatment with dapagliflozin versus     sitagliptin. Following matching, demographics and baseline characteristics will be assessed     using standardized differences to determine balance in the post-matched sample. Outcomes will     be assessed using tests for paired data (paired t-tests, signed rank tests, McNemar's tests).   "
15848|NCT03078036|"     BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes     Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor     receptor 2 negative metastatic breast cancer patients who have started 1st line systemic     cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer     susceptibility gene in an otherwise unselected population, describe the treatments     administered and estimate the associated clinical outcomes of overall survival and     progression-free survival amongst mutation carriers within the context of a low poly ADP     ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken     to describe somatic breast cancer susceptibility gene and other homologous recombination     repair gene mutations.   "
15849|NCT03078023|"     Are we able to use the EPO staining technique using the sponge ?   "
15850|NCT03078010|"     The purpose of this study is to see how different antibiotics affect the community of     friendly bacteria existing in the intestinal tract (gut). Under normal circumstances, these     friendly bacteria are not harmful and they help with normal bodily functions such as     digestion. When these bacteria are absent, several complications may occur, such as     infections with harmful bacteria or other inflammatory reactions, that can complicate the     stem cell transplant course. Treatment with antibiotics or chemotherapy is known to kill off     these friendly bacteria. In this study we compare the effects of different antibiotics on the     community of friendly bacteria in the gut.   "
15852|NCT03077984|"     This project is one multi-center, a prospective cohort study, based on 1660 cases of ischemic     stroke patients with the treatment of 3 months, and 21 months of follow-up observation in     order to clarify the advantages and characteristics of integrated treatment of traditional     Chinese medicine sequela of apoplexy; With the formation of curative effect, to highlight the     advantage of the programme of comprehensive treatment of apoplectic sequela in traditional     Chinese medicine and its compound preparation; To form a active medical service mode of     stroke chronic disease management processes, as well as modalities and mechanisms for the     evaluation of the curative effect.   "
15853|NCT03077971|"     This is a feasibility study to evaluate whether it is possible to conduct a larger study to     evaluate whether providing psychological support to carers of people with MS is effective in     reducing carer strain. Whilst not all carers experience distress as a result of their caring     duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in     a self-help format. Participants will learn about and use ACT by reading a book provided to     them by the study. One group will receive the ACT book, another will receive the same book     alongside weekly telephone support to use the book, and a third group will act as a control     group and therefore will not have extra support. Participants are allocated to the groups     based on chance (a computer will decide group allocation). Participants will complete     questionnaires before group allocation, and then again 3 months after they were allocated to     a group, and one final time 6 months after group allocation. Those who receive the self-help     book will get sent chapters each week for 8 weeks. The groups will be compared on scores from     the questionnaires and complete feedback interviews with a subgroup of those who receive the     book, to gain feedback about their experiences of the study.   "
15854|NCT03077958|"     100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will     be recruited from our waiting list. The patients will be randomized to become operated with     the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes.     Patients can only participate with one knee.   "
15855|NCT03077945|"     1. PURPOSE OF THE STUDY 1.1 Justification The purpose of the project is to examine the          effect of breathing biofeedback and thoughts about stress on performance under stress          and cigarette cravings. Smoking rates in the United States have been steadily going down          over the past 50 years, and now 16.8% of adults smoke (Centers for Disease Control and          Prevention, 2015). Most smokers try to quit, but end up going back to smoking          (Garcia-Rodriguez et al., 2013; Piasecki, 2006; Rafful et al., 2013). The reasons people          go back to smoking may have something to do with stress in their lives, particularly for          women who smoke. This study wants to see if we can reduce temporary stress and lower          craving to smoke after stress.           1.2 Description of the Research Project Approximately 60 adult women will participate in          the study. Participants must be between 18 and 65 years old, able to read English          fluently, and must agree to engage in the research procedures (stress protocol,          physiological assessment, breathing training, questionnaires) to participate. People who          are taking medications that interfere with physiological assessment are excluded from          participating including people with: self-identified substance use problems,          self-identified psychosis, morbid obesity (BMI>40), and people who take anti-cholinergic          medication, beta blockers, Ritalin, benzodiazepines, tricyclic antidepressants or          bupropion, varenicline, antipsychotic medication, or nicotine replacement therapy.          People who have a cardiac rhythm abnormality or major neurological problem are also          excluded from the study. Also, participants may not participate if they are pregnant or          color-blind. Participation is strictly voluntary.        2. PROGRESSION OF THIS STUDY 2.1 Procedures The study visit procedures will take place at          the Emotion and Psychopathology Laboratory at Rutgers University, located at the Rutgers          Institute for Health, Healthcare Policy, and Aging Research. Participants will first          complete some questionnaires and provide some basic information about themselves          (demographic information, responses to emotion and stress, and smoking history). Next,          participants will engage in a baseline psychophysiological assessment where          investigators will examine heart rate, breathing, and blood pressure. Next,          investigators will either ask participants to sit quietly for 30 minutes while          completing a computer task and watching short videos, or practice a specific deep          breathing exercise for 30 minutes. Then participants will do three tasks on a computer.          The tasks will ask participants to trace different shapes, answer math problems while          receiving feedback about how they're doing, and identify colors and words on a screen.          Finally, participants will be asked to sit quietly for 15 minutes before investigators          remove the psychophysiological recording equipment. One week after the study visit,          investigators will contact participants via phone to ask them some questions about the          study visit.      2.2 Duration of the study This study visit will last approximately 3 hours. Length of the     visit may vary because each individual may complete procedures at a different pace. The phone     call after the study visit will last approximately 10-15 minutes.   "
15856|NCT03077932|"     The investigators propose to develop a smartphone app (called OFFBup) that will help patients     manage opioid withdrawal during buprenorphine taper and detoxification. The OFFBup smartphone     intervention will be a resource patients can access anytime and anywhere. If the OFFBup     intervention were to be effective in helping patients undergoing buprenorphine detoxification     by decreasing relapse to illicit drug use, it could be integrated into the standard of care     of office-based buprenorphine clinical practices, as well as methadone programs, thereby     having a substantial public health impact.   "
15870|NCT03077750|"     A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase II Study to Evaluate the     Efficacy, Tolerability, and Safety of Topical VBP-245 in Pediatric Subjects for the Treatment     of Molluscum Contagiosum (VBP-245-MCV).   "
15857|NCT03077919|"     This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the     efficacy of right-sided stellate ganglion block (SGB) on the acute symptomatology of Post     traumatic Stress Disorder (PTSD), evaluated by the Clinician-Administered PTSD Scale (CAPS-5)     clinical interview at pre-treatment and at 8 weeks. This entry describes the effectiveness     study.The acceptability study is described in a separate entry.   "
15858|NCT03077906|"     Obesity surgery has become commonplace nowadays. This type of surgery is in full swing and     although it is mostly beneficial for the health of the patient (reduction of cardiovascular     risks, improvement of self image, reduction of osteo-articular risks, etc...) it is however     associated with risks. There are several short and long term complications, excluding the     ones related to the anesthesia and the post-op recovery: fistulas, abcesses, infections,     dysphagia, risks of endobrachyoesophagus, etc...      The gastroœsophageal reflux remains by far the most common post-op complaint within patients.     Patients can experience symptoms as far as 3 years after the surgery. Medical treatment alone     can in most cases lighten the symptoms. However, in some cases, this treatment fails and     another type of surgery (bypass) must be undertaken, which is psychologically traumatic for     the patient.      This retrospective study will analyze a cohort of patients who underwent bariatric surgery     (mainly sleeve gastrectomy), in order to identify those at risk of developping     gastroœsophageal reflux and how this complication can be avoided in pre-op. The study will     also identify cases of invalidating gastroœsophageal reflux that can be solved by obesity     surgery.   "
15859|NCT03077893|"     A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in     changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with     diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through     120-day period.   "
15860|NCT03077880|"     The aim of this observational study is the evaluation of marginal bone remodeling after     surgical implant placement, correlating the gingival thickness with the bone resorption rate.   "
15861|NCT03077867|"     This is set as prospective clinical trial to correlate histologically and radiologically the     performance of four different bone grafts (synthetic hydroxyapatite alone, synthetic     hydroxyapatite mixed with polylactic-polyglycolic acid, synthetic hydroxyapatite with i-PRF     and inorganic bone graft) in the sinus floor elevation technique with lateral approach for     the treatment of atrophic crests.   "
15862|NCT03077854|"     Thoracic radiotherapy (TRT) is a standard curative treatment for locally advanced,     unresectable non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer     (SCLC). TRT has been recognized to cause moderate to severe lung injury in a substantial     portion of patients. Conventional standard curative TRT planning techniques minimize the     radiation dose to the anatomical lungs, without adaption of regional pulmonary function     variations. The principal investigator hypothesized that preferential avoidance of functional     lung during curative TRT may decrease the risk of pulmonary toxicity. Functional lung regions     are identified using four- dimensional computed tomography for ventilation imaging. This     randomized, single-blind trial will comprehensively assess the impact of functional lung     avoidance on pulmonary toxicity, quality of life, and clinical outcome in patients receiving     curative TRT for locally advanced NSCLC and SCLC.   "
15863|NCT03077841|"     The goal of this clinical research study is to learn about the side effects that may occur     after radiation is given to breast cancer patients for 2 to 2½ weeks at the part of the     breast where the disease first started. Researchers also want to learn if this treatment can     help to control the disease and prevent the cancer from coming back in the breast.   "
31523|NCT02873156|"     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and     pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.   "
15864|NCT03077828|"     The purpose of this research study is to evaluate a new drug Pembrolizumab in combination     with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is     called ICE and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab     is currently Food and Drug Administration (FDA) approved for the treatment of some patients     with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the     treatment of Relapsed/Refractory Hodgkin Lymphoma. The 'ICE' regimen of chemotherapy is     currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not     yet been investigated in combination with pembrolizumab for this disease. For patients who     have a relapse of their Hodgkin's lymphoma, retreatment with chemotherapy followed by a stem     cell transplant is recommended. We know that obtaining a complete remission (not able to     detect any disease on scans) is very important prior to proceeding to the stem cell     transplant. Patients with negative scans have a lower chance of the disease coming back and a     higher chance of achieving a long-term cure.   "
15865|NCT03077815|"     Arm vein intermittently gripping arm movements, can promote the increased diameter of     arteriovenous fistula, which enhance the maturity of fistula, the effect of lack of empirical     research. Objective: this study, randomized controlled study, investigate systematic random     arm vein pressure and arm movements to arteriovenous fistula in hemodialysis patients improve     the maturity rate and effectiveness of the diameter. Methods: a prospective comparative study     randomly assigned.   "
15866|NCT03077802|"     The investigators intend to compare the Seldinger technique and modified Seldinger technique     on success rate and complications during central venous catheterization by a prospective,     randomized, controlled study. The investigators are planning to compare both techniques in     both experienced (anesthesiologist board member) and non-experienced practitioners (first and     second-grade resident).   "
15867|NCT03077789|"     Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity     at 4 years of age.      The delay in diagnosis is a factor of poor visual acuity. Will justify the implementation of     information programs with health and education professionals in order to improve the     functional prognosis of patients with congenital glaucoma.   "
15868|NCT03077776|"     A prospective multicentre study which aims to examine the relationship between intratumour     heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with     histological confirmation of triple-negative breast cancer (TNBC) who are eligible for     neoadjuvant chemotherapy.   "
15869|NCT03077763|"     The study is a pharmacodynamic random order cross-over trial investigating the physiological     effects of intra-arterial infusion of nitrite following a haemolysed autologous blood     transfusion.   "
15871|NCT03077737|"     Most smokers, especially those who are poor, do not receive smoking cessation treatment     during their healthcare visits. This study is evaluating a novel population health management     intervention for low-income smokers. Automated via an EHR system, which is bidirectionally     linked with the Illinois Tobacco Quitline, the intervention comprises a mailed letter and     text messaging designed to motivate low-income patients, most of whom are not ready to quit,     to accept and use proactive quitline treatment. Increased access to free effective treatment     via the integration of healthcare systems and state quitline services may be especially     significant in its impact on low-income smokers who are underserved and who carry a much     greater burden of tobacco-related disease.   "
15872|NCT03077724|"     The purpose of this feasibility study is to obtain pilot data in preparation for an upcoming     R01 submission. The goals of that submission will be to conduct a clinical trial of n-3     LCPUFAs for smoking cessation in pregnant women. For this proposal, the investigators will     develop, test, and refine the recruitment strategy and collect data demonstrating the     investigators ability to successfully recruit pregnant women who are actively smoking. The     investigators will collect side effect, tolerability, and adherence data regarding the     intervention. Finally, the investigators hope to gather preliminary effect size data to allow     more formal estimates of sample size. The investigators hypothesize that pregnant smokers     randomized to n-3 LCPUFA supplementation will have higher smoking cessation rates and less     nicotine cravings compared to women allocated to placebo. The investigators intend to use     this preliminary data to inform a future randomized, double-blind, placebo-controlled trial     of n-3 LCPUFA supplementation for tobacco cessation.   "
15873|NCT03077711|"     Several methods are available for use in the prevention of recurrent urinary tract infections     (UTIs) over the past few decades. These methods include suppressive antibiotics, estrogen     cream, methenamine hippurate, d-mannose, cranberry, probiotics, and vitamin C. Of these, the     majority of the literature is in favor of use of suppressive antibiotics for preventing UTIs.     However, this data is now about 10 years old. Increasing use of antibiotics over the years     has lead to increased resistance of bacteria. In addition, long-term antibiotic use has     several adverse effects, some life-threatening. There is recent literature evaluating the use     of several of the alternatives to suppressive antibiotics with mixed results. A comparative     study of the efficacy of methenamine hippurate to suppressive antibiotics is lacking in the     current literature. Several early partly-randomized trials done with methenamine hippurate     have shown promising results, but are only as recent as 1987. The primary objective of this     prospective, randomized study is to determine whether there is a significant difference in     the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive     antibiotics. The secondary objective of this study is to determine how well patients are able     to tolerate each of these medications and what adverse effects are observed in a given 1 year     time period. The long-term goals of this study are to find an alternative to using     suppressive antibiotics, potentially with a lower adverse effect profile and less of the     dangers of long term antibiotic use. Finding an alternative to suppressive antibiotics would     also tackle the issue of antibiotic resistance.   "
16096|NCT03074799|"     To assess implementation of a nurse-led, symptom-based screening program in local,     decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old     who were exposed to tuberculosis in the home. This will allow nurses in decentralized clinics     to either start IPT for those asymptomatic patients and refer symptomatic patients for     evaluation of TB disease and possible antituberculous therapy (ATT).   "
15875|NCT03077685|"     Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally     advanced pancreatic adenocarcinoma located in the tail or body of the pancreas via direct     intratumoral injection.   "
15876|NCT03077672|"     Mitochondria are organelles (a specialized subunit of a cell) responsible for providing cells     with energy. For reasons not yet understood, mitochondria will release their DNA into blood     in response to cellular injury or cell death.      With a simple blood draw, investigators can measure the amount of mitochondrial DNA in a     patient's blood.      The investigators' hypothesis, is that mitochondrial DNA can be used as a surrogate marker of     cellular injury to predict patient outcomes. The investigators intend to test their     hypothesis by measuring mitochondrial DNA in adult patients presenting to the Emergency     Department with sepsis (a life-threatening condition due to an infection) and observing their     hospital course.   "
15877|NCT03077659|"     Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15     mg/mL in subjects with prostate cancer scheduled for prostatectomy.   "
15878|NCT03077646|"     There is currently no available data regarding using the inpatient setting as an opportunity     to talk to parents/guardians about firearm safety. The investigators will be doing a     pre-/post-intervention study to investigate the effect of an intervention (a 5.5 minute Be     SMART video and written materials developed by the organization Everytown for Gun Safety), on     parental/legal guardian knowledge, attitudes and practices regarding firearm safety. While     the American Academy of Pediatrics recommends the safest home for children is one without     guns, the reality is that there are families with guns in the home. This non-political video     focuses on ways to keep children safe from firearms.      The investigators will also investigate any additional effect of physician-delivered     counseling on parental/guardian knowledge, attitudes and practices regarding gun safety as     compared to receiving the information solely via video and written materials.      Participants will be randomized to 1 of 3 groups (intervention, intervention + MD discussion     and control group). Outcomes will be assessed immediately post intervention and in a 30-day     follow up phone call.   "
15879|NCT03077633|"     A prospective randomized control trial that will compare cervical cerclage plus vaginal     progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix     (</= 15.0mm) between 16w0d to 25w6d.   "
15880|NCT03077620|"     The purpose of this study is to change the concentration of amyloid-beta in human     cerebrospinal fluid (CSF) by modification of sleep efficiency.   "
15881|NCT03077607|"     This is a study in patients with advanced solid tumors for the investigation of P-gp     inhibition and induction on the PK of talazoparib.   "
15882|NCT03077594|"     To prospectively assess the functional aspects of the the esophageal squamous epithelial     barrier and correlate this with tissue inflammation and intercellular space dilation in     patients who have successfully completed endoscopic therapy for Barrett's Esophagus related     metaplasia.   "
15883|NCT03077581|"     This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to     three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and     subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score,     total analgesic rescue requests and the total amount of systemic rescue analgesia used in the     first postoperative day in addition to any detected postoperative complications were also     recorded.   "
15884|NCT03077568|"     A randomized controlled trial is needed to strengthen the evidence in the area of web-based     self-management programs for stress-reduction.      Aim The aim for the study is to compare the effects of the web-application that supports     behavior change in stress-management to a waiting list group in persons with perceived     stress.      Method This study will have the design of a randomized controlled trial (RCT). The CONSORT     guidelines will be used for reporting the study.      Sample: Different sectors in the region will be included. Three different high-schools in     Västerås City, social services authority in Västerås municipality, a large private company in     the region, three different clinics within the county council and the municipality of Köping     have signed the attestation of participation.      Intervention: The intervention is the program for web-based stress self-management My Stress     Control.      Procedure: After informed consent the participants will, during approximately 2-4 months by     their own go through the web-based program for stress self-management. The waiting-list group     will also get access to My Stress Control after post-measurements.      Data-analysis: Descriptive statistics will be used for demographic data. Missing data will be     replaced as recommended for the different measurements included, commonly by using the mean     for responded items within the sub scale. Inferential analyses will be conducted by using     multivariate statistical analysis.      Drop-out analysis will be conducted by comparing pre-interventions measures for those who     completed the program with those who did not.   "
15895|NCT03077425|"     The CHALO (Child Health Action to Lower Oral Health and Obesity) -- from an Urdu word     meaning Let's go!—is a multi-level strategy to reduce pediatric obesity and dental caries     risk in South Asian (SA) children. Obesity and caries are the two most prominent health     disparities of early childhood. Both caries and obesity: a) disproportionately impact     low-income children of color, b) share common risk behaviors, i.e., feeding practices, and c)     can most effectively be reduced or prevented prevention in infancy and early childhood. SA     immigrant children are at high risk for both. CHALO includes both a randomized controlled     trial (RCT) aimed at reducing risk behavior, and a Knowledge Translation project to raise     awareness in SA lay and professional communities regarding child health risks.   "
15886|NCT03077542|"     Background:      Peripheral blood stem cell transplantation procedures are used for people with sickle cell     disease. Researchers want to improve the success and reduce the complications for these     procedures. This might allow more people to have a transplant.      Objective:      To see if a new transplant regime is effective, safe and well tolerated in people with sickle     cell disease.      Eligibility:      Adults at least 18 years old with sickle cell disease and certain complications.      A relative who is a half tissue match.      Design:      Participants will be screened with medical history, physical exam, and blood tests.     Recipients will also have:        -  Heart, lung, and mental health tests        -  Chest x-rays        -  Bone marrow taken from the pelvic bone        -  Eyes and teeth checked      Recipients will have a large central line inserted into a vein for up to 6 months.      Donors will have their veins tested and have an IV inserted for 1 day or on rare occasions 2     days.      Donors will get a drug to activate bone marrow. It will be injected for about 6 days.      Donors will have at least 1 five-hour procedure where bone marrow stem cells will be     collected. Blood will be taken from a vein in one arm or in rare cases from a groin vein and     put through a machine. Some blood will be saved and the rest will be returned. Stem cells     will be taken from the saved blood in a lab and frozen until ready to give to the recipient.      Recipients will have:        -  Stems cells collected and frozen        -  Hygiene lessons        -  Bone density scans        -  Low-dose radiation        -  Drugs for their immune system        -  Donor cells infused through their central line        -  Transfusions      After about 30 days, recipients will leave the hospital. They must stay near NIH for 3 months     after the transplant and have frequent visits. After returning home, they will have 8 visits     over 5 years, then be contacted yearly.   "
15887|NCT03077529|"     The population is aging worldwide, concomitant frailty is increased in older age groups.     Frailty has a strong impact on outcomes of multi-morbidity and daily living, thereby     negatively influencing quality of life and health care costs. Prevention or delay of onset of     frailty associated with aging is needed. Dietary intake of galacto-oligosaccharides (GOS) may     have beneficial effects on microbiota composition and health outcome parameters. As     microbiota composition and function may be altered in elderly compared to younger adults, it     will investigated whether the effects of GOS on selected parameters of microbiota and gut     health differ between elderly versus younger adults. The primary objective of this study is     to compare the effects of four weeks GOS supplementation on intestinal microbiota composition     and activity in elderly versus younger adults. Further, this study has four secondary     objectives. The study conforms to a randomized double-blind placebo-controlled cross-over     design per age-group. Study populations are human volunteers (male and female), healthy young     adults of 25-50 years and prefail older adults of 70-85 years old, BMI 20-30 kg/m2. One     intervention period subjects will receive 7.2 grams of Vivinal® GOS Powder three times daily     for four weeks. The other intervention period subjects will receive isocaloric placebo     supplements (5.7 grams maltodextrin) three times daily for four weeks. At the start and end     of each intervention period, several measurements will take place. There will be a washout     period of four to five weeks between intervention periods. The main study parameter is the     change in microbial composition and activity induced by GOS intervention, in younger adults     and elderly.   "
15888|NCT03077516|"     The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years     following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies   "
15889|NCT03077503|"     To compare the effect between dexmedetomidine and fentanyl for controlling the hemodynamic     response to skull pins application   "
15890|NCT03077490|"     Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a     mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall     prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.   "
15891|NCT03077477|"     This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of     orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.      The study is comprised of a total of 8 cohorts; 4 single ascending dose (SAD) cohorts, 1 Food     Effect (FE) Crossover cohort, and 3 multiple ascending dose (MAD) cohorts. Tablets will be     administered after an overnight fast (10 hours) with at least 250 mL water. No food will be     administered (exception for fed subjects, see below) for one hour thereafter.      Each cohort will have a total 6 subjects: SAD and MAD (2 subjects receiving placebo and 4     subjects receiving active AMXT 1501 dicaprate); and FE crossover (6 subjects receiving active     AMXT 1501 dicaprate).   "
15892|NCT03077464|"     Healthful eating is a core component of a healthy lifestyle that is associated with lower     risk of obesity and chronic disease. Although adolescent health promotion programs have been     extensively evaluated and applied in English-speaking Western developed nations, there is     very little published literature in the Russian context. Our study seeks to determine the     relative effectiveness of a healthy lifestyle intervention consisting of nutrition education     at a Russian camp. Investigators will determine the impact of behaviorally focused nutrition     education on nutrition knowledge, food choice, attitude, and self-efficacy for healthful     eating, compared to standard nutrition education.   "
15893|NCT03077451|"     This pilot phase II trial studies how well nelfinavir mesylate works in treating patients     with kaposi sarcoma. Nelfinavir mesylate may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
15894|NCT03077438|"     The aim of this trial is to evaluate the immunogenicity and describe the safety of MenACYW     conjugate vaccine compared to MENVEO® in healthy children 2 to 9 years of age in the United     States.      Primary objective:      - To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups     A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine     compared to that observed following the administration of a single dose of MENVEO® in     children aged 2 to 9 years.      Secondary objectives:        -  To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A,          C, Y, and W following the administration of MenACYW conjugate vaccine to those observed          following the administration of MENVEO® in children 2 to 9 years of age        -  To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following          the administration of MenACYW conjugate vaccine and those observed following the          administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years          of age, respectively.        -  To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W          before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in          children 6 to 9 years of age, respectively.      Observational objective:      - To describe the safety profile of MenACYW conjugate vaccine and that of the licensed     MENVEO®.   "
15896|NCT03077412|"     The primary objective of this study is to evaluate the efficacy of filgotinib as compared to     placebo in establishing combined fistula response at Week 24. Participants will have the     option to enter a separate long-term extension study if they meet eligibility requirements.   "
15898|NCT03077386|"     In Canada, the prevalence of chronic disease is increasing and patients presenting with     multiple conditions (i.e., multimorbidity) are becoming the norm in primary care. Complex     treatment regimens such as administration of medications (including insulin), clinical     monitoring and screening for complications, adherence to dietary and lifestyle changes, and     decisions about when to seek medical care are challenging. To help people with complex health     conditions optimize their care and outcomes, community health worker programs have begun to     be used across the United States and Canada. Existing community health worker programs share     a common goal of helping patients to overcome modifiable barriers to care to achieve optimal     outcomes.      While community health workers may work within a primary health care team, the primary role     of the community health worker is not clinically oriented, and may be fulfilled by     laypersons. Depending on the targeted barriers, specific tasks may include one or more of:     disease education, health system education, assistance with insurance coverage, aid in care     coordination, and referral to community resources, among others. Herein, the investigators     aim to evaluate the effectiveness of a community health worker intervention on improving     acute care utilization among patients with complex chronic disease seen in primary care.   "
15899|NCT03077373|"     This study examines the efficacy of individualized counseling letters to reduce systolic     blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The     computer-generated counseling letter intervention aimed to increase moderate-to-vigorous     physical activity, to reduce sedentary time, and to achieve smoking abstinence.   "
15900|NCT03077360|"     The rationale for the proposed research is that elucidating changes in localized     diacylglycerol (DAG) and sphingolipid species that predict insulin sensitivity will reveal     specific localized lipids to target in therapeutics for type 2 diabetes. To attain the     overall objective, the investigators propose three specific aims: 1. Identify the influence     of sarcolemmal DAG and sphingolipids on cell signaling and insulin sensitivity before and     after insulin sensitizing lifestyle interventions. Strong preliminary data shape the     hypothesis that sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species will decrease     after insulin sensitizing lifestyle interventions, leading to less Protein kinase C (PKC) and     Protein phosphatase 2A (PP2A) activation, and enhanced insulin signaling. Skeletal muscle DAG     and sphingolipid isomers, species, localization, and de novo synthesis will be measured     before and after diet-induced weight loss or exercise training interventions in obese men and     women. Insulin sensitivity will be measured using insulin clamps, and muscle lipids using     Liquid Chromatography Mass Spectrometry (LC/MS). 2. Determine the impact of mitochondrial/ER     (endoplasmic reticulum) DAG and sphingolipids on mitochondrial function and ER stress in     vivo, before and after insulin sensitizing lifestyle interventions. The investigators     hypothesize, again based on preliminary data, that mitochondrial/ER sphingolipids will     decrease, yet DAG will increase after insulin sensitizing lifestyle interventions, and each     will associate with increased insulin sensitivity. Changes in sphingolipids will relate to     increased mitochondrial function, less ER stress, reactive oxygen species (ROS), and     acyl-carnitine formation, while changes in DAG will relate to increased mitochondrial content     and dynamics. 3. Identify the effect of exogenous DAG and sphingolipids on mitochondrial     function in vitro, before and after insulin sensitizing lifestyle interventions. The working     hypothesis is that DAG and sphingolipids will reduce mitochondrial respiration and increase     ROS and acyl-carnitine content, but will be attenuated after endurance exercise training. The     proposed research is innovative because it represents a substantive departure from the status     quo by addressing cellular compartmentalization of bioactive lipids. The investigators     contribution will be significant by identifying key species and locations of DAG and     sphingolipids promoting insulin resistance, as well as mechanisms explaining accumulation     that could be modified by insulin sensitizing therapeutic interventions.   "
15913|NCT03077191|"     This is an homogeneous, single institution, observational, non -interventional, prospective     study of 500 patients who will be treated according to the standard protocol of adjuvant     hypofractionated radiotherapy after breast conserving surgery, with forward-planned     intensity- modulated radiation therapy (IMRT) to a total dose of 40 Gy/ 15 fr (5 fr/ week, 3     consecutive weeks). In addition to the regular follow up, the patients will have to respond     to the quality of life questionnaires (QLQ) of European Organisation for Research and     Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at     the first visit, at the end of radiotherapy ant then at the subsequent follow-up visits form     6 months up to 5 years and a half, to evaluate the quality of life during and after the     treatment. The study has also a retrospective arm, the evaluation of disease control and     toxicity results in approximately 1300 patients treated from January 2009, when the     hypofractionated radiotherapy has been adopted as a standard after breast conserving     radiotherapy, up to 2016.   "
15914|NCT03077178|"     In order to describe functional impact of surgery in elderly patients treated for lower-limb     soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic     factors among geriatric and functional assessment.   "
15901|NCT03077347|"     The purpose of this study is to better understand the neural correlates of cognitive control     (CC) deficits in schizophrenia and determine how these mechanisms can be modulated by     transcranial direct current stimulation (tDCS). CC is a critical neurocognitive process that     is required for flexible, directed thought and action based on goals and intentions.     Identifying and developing paradigms to improve CC is therefore a mental health priority.     Current theories of CC postulate that recruitment of the dorsolateral prefrontal cortex     (DLPFC) is essential for this process by maintaining high-level information that it can then     use to orchestrate patterns of activation in other brain networks to support optimal     performance. tDCS is a safe, noninvasive method of modulating regional brain excitability via     brief (15-20 m) application of a weak (1-2 mA) current. The goal of the proposed experiments     is to combine tDCS with functional magnetic resonance imaging (fMRI) to test the hypotheses     that 1) acute tDCS over the DLPFC can improve performance during a CC task (the dot pattern     expectancy (DPX) variant of the AX-Continuous Performance Task) in schizophrenia patients and     healthy control subjects, and 2) acute tDCS over the DLPFC can increase recruitment of the     DLPFC during the DPX. Effects of tDCS on brain functional connectivity (during CC as well as     during the resting state) will also be examined, as well as effects on an episodic memory     task. The current study will be the first to use functional magnetic resonance imaging (fMRI)     to examine the effects of tDCS on the neuronal mechanisms of CC in schizophrenia, and has     potentially important implications for therapeutic development for this treatment refractory     yet disabling aspect of the illness.   "
15902|NCT03077334|"     The 18F-FDG-PET scan is currently being used for cancer diagnosis, staging, identifying     hidden metastasis, and assessment of treatment responses in clinical oncology. Although there     are important studies suggesting potential associations between PET-based parameters and     oncologic outcomes, the calculation and official documentation of individual PET-based     parameters might not be routine in clinical practice because these processes usually require     time- and labor-consuming processes for the radiologists. In this study, the investigators     prospectively determined clinical 18F-FDG-PET type according to degree of FDG-uptake in     pancreatic cancer and compare oncologic outcomes between the types.   "
15903|NCT03077321|"     This is a randomized clinical trial of the impact of incorporating a peer mentor into a     primary care based group parenting program on increasing program participation by parents and     improving program outcomes.   "
15904|NCT03077308|"     The overall purpose of this project is to advance understanding of the neurophysiological     features of Rett syndrome (RTT), MECP2 Duplication (MECP2 Dup) and RTT-related disorders     (CDKL5, FOXG1) to gain insight into disease pathogenesis, with an emphasis on identifying     biomarkers of disease evolution and severity. This specific study is intertwined to the core     study Natural History of Rett Syndrome and Related Disorders (RTT5211), which characterizes     range of clinical involvement and genotype-phenotype correlations and will provide     phenotypical data for determining the clinical relevance of the neurophysiologic parameters;     study subjects here are co- and primarily enrolled in RTT5211. The proposed studies will     serve as basis of future translational investigations, including further refinement of     biomarkers, development of outcome measures, and clinical trials per se.   "
15905|NCT03077295|"     This weight loss study will investigate the impact of diet composition and meal size (large     breakfast meals and smaller evening meals) on body weight, energy balance and eating     behaviour, by altering calorie (meal) distribution.   "
15906|NCT03077282|"     To investigate the safety of Prasaprohyai 95% ethanolic extract at doses of 100 mg and 200 mg     for for 6 weeks. (Clinical Trial phase I)   "
15907|NCT03077269|"     The purpose of this study is to understand what happens to platelets and blood clotting     factors in burn patients over time. This study will also examine the role of microparticles     (MPs), nanoparticles (NPs), and micro RNA in burns. The investigators will be looking at     small particles of cells that are released into the blood. These particles have been found to     be important in a variety of different diseases. The investigators believe that MPs, NPs, and     micro RNA may play a role in development of inflammation, and infections in burn patients.     Thus, hopefully, this study will help understand how to minimize transfusions and bleeding in     burn patients as well as how to reduce inflammation and infections in burn patients.   "
15908|NCT03077256|"     This prospective registry was designed as an observational study to ascertain how     commercially available Burst Products are being used by foot and ankle surgeons performing     procedures which involve bone grafting, as well as determining relevant patient outcomes.   "
15909|NCT03077243|"     The primary objective of this study is to evaluate whether genomic based risk-stratification     can be used in deciding whether to de-intensify in patients with Human Papillomavirus     (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with > 10 pack years smoking     history. Hypothesis: Patients with HPV-associated OPSCC, > 10 pack years smoking history, and     non-mutated p53 will have similar 2 year progression-free survival (PFS) as patients with <     10 pack years smoking history.   "
15910|NCT03077230|"     The primary objective of this study is to assess the effect of the decision aid on measures     of decision-making such as knowledge, screening attitudes, decisional conflict, and screening     intent.   "
15911|NCT03077217|"     Several studies have been showed that rifaximin can improve cognitive functions, driving     simulator performance and health-related quality of life in patients with minimal hepatic     encephalopathy. The aim of this prospective randomized open controlled study was to evaluate     the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic     encephalopathy.   "
15912|NCT03077204|"     The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients     undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.     Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS     Cervical Allograft (with graft window).   "
15915|NCT03077165|"     Dose-response relationship study of S42909 on leg ulcer healing after oral repeated     administration in patients with active venous leg ulcer.   "
15916|NCT03077152|"     Up to 90% of consulting Acute Exacerbation (AE) of COPD patients are prescribed an     antibiotic(1).      Rates of inappropriate antibiotic prescription percentage can be as high as 65%(2).      Excessive use of antibiotics is correlated with higher prevalence of antimicrobial     resistance(3). There are insufficient data regarding the overprescribing antibiotics in     AECOPD in our country.Therefore the investigators aimed to investigate the patients factors     that are associated with the prescription of antibiotic for inappropriate indication in     AECOPD.This is an observational cross sectional study.Population: AECOPD patients with     AB(antibiotic) prescription Exposure: Presence of patient factors, Comparison: Absence of     Patient factors, Outcome: Prescription of antibiotic for inappropriate indication.      Sampling:      Consecutive patients presenting to pharmacy between Monday and Friday. Date between January 1     2017 to January 1 30 2019. Primary Outcome:Prescription of antibiotic for inappropriate     indication according to Anthonisen criteria for AECOPD Anthonisen criteria:-Worsening of     dyspnea        -  Increased sputum volume        -  Increased sputum purulent 3/3 →Type 1 or severe AE 2/3 →Type 2 or moderate AE 1/3 →Type          3 or mild AE AB indicated/useful in Type 1 or severe AE, and Type 2 or moderate AE if          sputum is purulent The data will be obtained from the database.      Exposure:      Patient factors that lead to inappropriate antibiotic prescription (will be considered     together in analysis due to confounding) FEV1% Age Current smoker Comorbidities (Charlson     comorbidity index) having Frequent exacerbations (≥2 past year) Use of oral steroids     Polypharmacy Quality control:Detailed MOP will be developed, A manual for protocol will be     written and used to inform the pharmacist,Pharmacist will be trained; to speak to     participants in a neutral manner for written informed consent for the security ID(identity)     data of the patients,This study will not affect the time period of the participants to access     his/her drug. The pharmacy will use the questionnaire within the time period planned. A     checklist for exclusion criteria will be developed. A plan for missing data will be     developed.      Null hypothesis:      Patient factors are not associated with the prescription of antibiotics for inappropriate     indications in patients with AECOPD      Alternative hypothesis:      Patient factors are associated with the prescription of antibiotics for inappropriate     indications in patients with AECOPD Analysis The data will be analysed using SPSS version     22.0 The investigators will compare exposure variables between inappropriate and appropriate     prescription groups Continuous variables - t test or Mann Whitney Binary- chi square test The     investigators will use logistic regression to measure the associations between patient     factors and the outcome of prescription of antibiotics for inappropriate indication Sample     size and power Sample size to estimate CI of 15% around 25 to 50% prevalence of inappropriate     prescription with p=0.05 and Power 80% Expected proportion0,25 128 0,50 171 Sample size and     power For logistic regression - estimate 30% prevalence (n=143), or about 42 events . The     investigators also need 5-10 events for each variable in the model, so this provides     sufficient power for 4 to 8 factors.      Limitations This study will just determine an association not causality      The investigators won't be able to determine if the participant is truthful to the pharmacist      The history of participants will be assessed from hospitals e-database - potential for     missing data.      The Anthonisen criteria for identifying inappropriate AB for AECOPD are still debatable The     investigators can not modify many of the patient factors, but may be able to identify     patients at higher risk of inappropriate antibiotics Ethics The project will be submitted to     the ethical committee of Dr. Suat Seren Chest Disease Hospital Oral and written informed     consent will be obtained from all subjects The study will be conducted in accordance with     Good Clinical Practice Guideline Relevance This study will be the first one to evaluate an     association between patient factors and prescription of antibiotic for inappropriate     indication in an outpatient clinic of patients with AECOPD in Turkey.      Subsequent studies should evaluate physician factors prescription of antibiotic for     inappropriate indication.   "
15917|NCT03077139|"     This study is being conducted to determine whether patients with advanced pulmonary     hypertension when treated with cardiac resynchronization therapy improve hemodynamically     and/or receive clinical benefit.   "
15921|NCT03077087|"     This is a prospective, descriptive, pilot case series involving patients with significant     burns who are candidates for reconstruction with Integra®. Subjects would have a small area     of the wound would, at the time of excision, have the smallest sheet of thin Integra® (125     cm2) placed and be immediately autografted with a 3:1 meshed split-thickness skin graft. Of     note, 125 cm2 represents approximately 0.7% of an average sized patient's total body surface     area, so for even the smallest burns in our proposed trial, this area would represent a small     portion of the patient's area of injury. The remaining injury areas would be covered with     standard-thickness Integra® only.   "
15922|NCT03077074|"     The aim is to profile and elucidate the hormonal and neurological system interaction to food     related behavior. The stimulus used will include visual and taste (gustatory) stimuli. The     study will profile induced correlations of metabolic parameters, gut hormones and brain     region (ROI - regions of interest) activation and interaction. In this study we will use fMRI     (functional MRI) to compare brain responses in obese, normal-weight and reduced weight     subjects. The food stimuli will be blocked into specific categories to allow for     investigation of different responses to alternating energy density foods. The response will     be tested prior to and following a brief low carbohydrate dietary regimen.   "
15923|NCT03077061|"     The project will evaluate the potential benefit of the use of bone replacement graft as an     adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed     randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140     systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be     treated with or without bone replacement graft. Outcome measures include assessments of     inflammation, probing depth, recession, radiological parameters and PROMs.   "
15924|NCT03077048|"     Supplementation of ketoanalogues of essential amino acids improves the protein quality of     protein restricted diets without burdening the kidneys. The ketoanalogues are transaminated     by aminotransferases to the corresponding amino acids by incorporating nitrogen from amino     groups derived from endogenous amino acid degradation. Therefore, less nitrogen needs to be     excreted and the kidney's workload is reduced.      The purpose of the trial is to investigate the impact of Ketosteril® supplementation on A)     nutritional safety and tolerance of a low protein diet (LPD) (0.6 g protein/kg bodyweight     (BW)/day)and B) net protein synthesis in pre-dialysis CKD patients.      Changes of urea in serum and urine will be assessed under controlled metabolic balance     conditions in non-dialysed CKD patients consuming a LPD supplemented with Ketosteril® at 1     tablet/5 kg body weight/day compared to the same, isonitrogenous and isocaloric diet without     Ketosteril®.      Changes in protein synthesis and degradation at the defined protein intake with or without     Ketosteril® supplementation will be investigated - based on nitrogen balance, normalized     protein catabolic rates as well as blood levels of defined proteins as surrogate markers for     net protein synthesis and anabolic signaling.   "
15925|NCT03077035|"     The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in     ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200     8-year-old children with at least 2 permanent molar with the International Caries Detection     and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based     sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents     placement and 6, 12 and 24 months after.   "
15926|NCT03077022|"     The treatment of femoroacetabular impingement has evolved over the last several years. As the     number of arthroscopic hip operations has risen over the last few years, so has the level     controversy in regards to the appropriate initial management. There have been many recent     advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery     and improved arthroscopic techniques which have led to improved clinical outcomes, but the     effectiveness of physical therapy remains unknown.   "
15927|NCT03077009|"     This is a study to assess the benefit of sodium hyaluronate (Ostenil) injection for plantaris     friction syndrome (PFS) associated with midportion Achilles tendinopathy. Functional outcome     scores will be recorded prior to treatment and at regular intervals up to 2 years. Changes in     tendon structure will be assessed using ultrasonographic tissue characterisation (UTC). UTC     will be performed prior to treatment and also at regular intervals up to 6 months following     injection.   "
15928|NCT03076996|"     This study will examine the feasibility and acceptability of an intervention designed to     improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence     among adolescents ages 15-19 years living with HIV enrolled in ART services.   "
15929|NCT03076983|"     The results of this study will help to define the capability and reliability of PulmoVista     500 to detect changes in both global and regional ventilation.   "
15930|NCT03076970|"     This is a randomized, double-blind, three-period, cross-over study to investigate the effect     of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan     200 mg.   "
15931|NCT03076957|"     The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety,     tolerability and pharmacokinetic profiles and to assess the efficacy of CKD-516 Tablet in     Combination with Irinotecan inj. in Patients with Previously Treated Advanced Colorectal     Cancer   "
15932|NCT03076944|"     The aim of this study is through a double blind randomized clinical trial, evaluate the     effectiveness of different clinical protocols in the reduction of dentin hypersensitivity.     The desensitization approach (single agent or associated agents) and the long-term     effectiveness (baseline, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks) will be evaluated.     Data will be collected, tabulated and submitted to statistical analysis.   "
15954|NCT03076658|"     A study of the skeletal structure and how the structure changes over time. The aim of the     study is to evaluate the skeleton in 10 year increments to determine an understanding of the     normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS)     can be used to evaluate the whole body to see changes in the bone structure over time.     Subjects will be asked to undertake one x-ray analysis of their whole body skeletal     structure. There will be 25 male and 25 female subjects per decade. The averaging of the     measured skeletal parameters will provide information on changes over time generating a     standardized expectation of general changes in skeletal structure as participants age.   "
15955|NCT03076645|"     This study will measure the engagement of people with epilepsy in a mobile phone based     messaging platform as well as understand if there is an impact on their self-management   "
15933|NCT03076931|"     Objective:      The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an     imaging biomarker to support diagnosis and predict vibratory outcome after airway     reconstruction. Our protocol will involve eliciting and recording the following five     behaviors: (1) hard throat clear; (2) cough; (3) laugh; (4) short multiple phonations; and     (5) sustained phonation. These HSV recordings will be used to develop the biomarkers.      Study Design: A prospective cohort study of 60 patients, 36 who will undergo airway     reconstruction and 24 age matched controls.      Setting: Center for Pediatric Voice Disorders, Department of Otolaryngology, Cincinnati     Children's Hospital Medical Center      Methods: Subjects will undergo a full voice evaluation, including an HSV evaluation protocol,     at the main study site prior to airway reconstruction, 6 months post and 1 year post surgery.     Voice evaluation will include aerodynamic, acoustic, and perceptual voice assessments, a     pediatric voice handicap index questionnaire, videostroboscopy, and HSV. The airway     evaluation will include airway sizing and calibration.   "
15934|NCT03076918|"     This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for     photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT     with Aktilite®.   "
15935|NCT03076905|"     Open label evaluation of a single intravenous dose of F901318 to healthy male and female     subjects with pharmacokinetic and safety and tolerability evaluation.   "
15936|NCT03076892|"     This study aims to compare the efficacy and tolerance of a new photodynamic therapy device     (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic     keratosis of the scalp   "
15937|NCT03076879|"     In order to evaluate the effectiveness of nursing interventions aimed at the early detection     of cervical cancer, health belief and participation in the screening of women aged 40-55 at     risk for the purpose of cervical cancer, One-way blind pre-test and post-test randomized     controlled trial.   "
15938|NCT03076866|"     It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years     and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)   "
15939|NCT03076853|"     The aim of MATRIX-DPRS is to assess the clinical and organizational impacts of the use of the     medication record, opened, filled and managed by pharmacists (from private office and     hospital units) by hospital physicians in private and public healthcare establishments     (volunteers), for three clinical contexts: anaesthesiology visit before surgery, medications     abuse and emergency hospitalization, medications and elderly hospitalisations.   "
15940|NCT03076840|"     The hamstring muscle is an important muscle that affect the performance of almost all     activities of daily living. Since this muscle is a large muscle that pass across two major     joints (the hip and knee joint), it is more susceptible to become tight and to lose its     extensibility. On the other hand, there is no agreement on a standard protocol for the     treatment of hamstring tightness. Kinesio tape is one of the options for treatment of     hamstring muscle, it is a safe, passive and non-painful intervention, and if proven to be     effective it will help individuals especially those with poor compliance and poor tolerance     to painful stretching exercises. The aim of the present study is to investigate the acute     effectiveness of Kinesio taping on hamstring muscles extensibility. 96 students with     hamstring tightness will be recruited from the University of Dammam to participate in this     prospective experimental study. All participants will be assigned randomly to either a     Kinesio tape group, Sham tape group and control group. Outcome measures will be the hamstring     length measurement by using active knee extension test and strength measurement for hamstring     and quadriceps muscles by using a handheld dynamometer. Outcome measurement will be taken at     baseline and 15 minutes after the intervention.   "
15941|NCT03076827|"     Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has     a form that is increased in the morning and decreased in the evening. The investigators     expected to be influenced by circadian rhythm according to the time of operation, and     compared morning and afternoon surgery.   "
15942|NCT03076814|"     the Investigator will test the hypothesis that short term PDE5A inhibition (with tadalafil)     will reduce post-exercise edema by MRI in males with Becker Muscular Dystrophy.   "
15943|NCT03076801|"     This pilot randomized control trial will examine the role of choral singing on psychosocial     stress and cardiovascular outcomes in patients with ischemic heart disease (IHD). The     hypothesis is that choral singing will improve psychosocial stress in comparison to the     control group and this may have an impact on rates of hospitalization, death, myocardial     infarction and stroke in these patients.   "
15944|NCT03076788|"     The uncertainty concerning the onset and the extent of cardiac remodeling in response to     intensive training hinders medical evaluation by physician. A better knowledge of the     physiology of cardiac adaptation to training will enable physicians to correctly determine     whether observed patterns of cardiac remodeling are physiological or pathological. This     prospective study proposes to assess in a trained-athlete population the cardiac remodeling     in response to intensive exercise training. This study is observational, we do not interfere     with athlete's training.   "
15945|NCT03076775|"     Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36     weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal     treatment with betamethasone in the late preterm period significantly reduces neonatal     respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.      This research study will attempt to answer the following primary question: Does a management     protocol aimed at maintaining maternal euglycemia after ALPS decrease neonatal hypoglycemia,     compared to usual antepartum care? The research study will also collect information about the     relationship of timing of delivery after ALPS and neonatal hypoglycemia.   "
15946|NCT03076762|"     There is no consensus of the therapeutic efficacy and safety between suburothelial injection     and trigonal injection of botulinum toxin A (BoNT-A) in treatment of interstitial     cystitis/bladder pain syndrome (IC/BPS) It is unmet to clarify which injection method is     superior in clinical efficacy and patient safety. This study was designed in a randomized,     double-blind trial to test the therapeutic effects and adverse events between intravesical     BoNTA injection into suburothelium and trigone. The results of this study might provide     clinical evidence for a better therapeutic regimen of BoNT-A in the treatment of IC/PBS.   "
15947|NCT03076749|"     Background: ß-lactam (BL) antibiotics represent the main cause of allergic reactions to     drugs, inducing both immediate and non-immediate reactions. The diagnosis is well     established, usually based upon skin tests and drug provocation tests, but cumbersome.      Objectives: To design predictive models for the diagnosis of BL allergy, based on the     clinical history of patients with suspicions of allergic reactions to BL.      Methods: The study included a retrospective phase in which records of patients consulting and     explored for a suspicion of BL allergy (in the Allergy Unit of the University Hospital of     Montpellier between September 1996 and September 2012) where used to construct predictive     models; a prospective phase, in which we performed an external validation of the chosen     models, in patients with suspicion of BL allergy recruited from 3 allergy centres     (Montpellier, Nîmes, Narbonne), between March and November 2013. Data related to clinical     history and allergy work-up results were retrieved and analysed. Logistic regression and     decision tree method were used to design two models to predict the diagnosis of allergy to     BL.   "
15948|NCT03076736|"     To undertake a pilot study that will evaluate the feasibility and acceptability of procedures     to inform the design and delivery of a definitive RCT of SPA (which would assess the clinical     and cost effectiveness of SPA for people with aphasia)   "
15958|NCT03076606|"     Nurses participate to geriatric evaluations for falling patients. For these patients, it is     recommended to evaluate,especially, visual acuity but this is not currently done because it     is difficult to systematically combine with an ophthalmologic consultation.      The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and     Parinaud scales, without specifying the professional qualification. According to the nurse     competence decree of State Graduates, sensory disorders screening is a non-vulnerable     examination, and can be performed by nurses. Therefore, they can use these scales, after     training.      We propose to evaluate the correlation between visual acuity scores obtained by nurses in     geriatric consultations and an ophthalmologist.      This study should include 204 patients over 65 years, who have fallen at least twice in the     last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after     the geriatric consultation.   "
16039|NCT03075540|"     Compared to non-Latina Whites, Latinas have a higher prevalence of BRCA1/2 gene mutations but     lower use of genetic cancer risk assessments services (GCRA). This study will develop and     assess the impact of a novel culturally targeted media intervention to improve psychosocial     outcomes and GCRA use in Latinas at-risk of hereditary breast and ovarian cancer. If the     intervention is proven to be effective in a future randomized controlled trial, the     intervention can be disseminated to clinics and adapted to other ethnic groups.   "
15949|NCT03076723|"     The purpose of the study is to determine if the so called pulsatility curve, which describes     the relationship between intracranial pressure (ICP) and ICP pulsatility, can be used to     predict outcome of treatment, in the form of shunt surgery, in idiopathic normal pressure     hydrocephalus (INPH) and to guide the adjustment of shunt opening pressure after the surgery.     The main hypotheses of the study are:        1. The pulsatility curve may be the best auxiliary test to predict shunt surgery outcome in          INPH patients. With a fixed shunt opening pressure, the preoperatively assessed          potential pulse amplitude reduction (determined by analysis of the pulsatility curve)          predicts postoperative improvement in gait velocity and cognitive functions.        2. A postoperative pulsatility curve can be used to further optimize ICP pulsatility by          guiding opening pressure adjustment. Shunt adjustment based on the pulsatility curve          three months postoperatively will increase improvement, but not complications, compared          to a shunt with fixed opening pressure.      Based on these hypotheses, three specific aims for the study have been defined:        1. To determine if improvement three month after surgery is associated with postoperative          reduction in pulse amplitude.        2. To determine if a pulsatility curve obtained preoperatively can predict improvement in          gait velocity and cognitive functions in INPH patients three months after surgery.        3. To compare outcome six months after surgery and complications rates between INPH          patients with a fixed opening pressure versus those where the shunt has been adjusted          based on the pulsatility curve, three months after the shunt insertion.   "
15950|NCT03076710|"     The primary objective of this pilot study is to assess the feasibility of comparing two     standardized approaches to manage post-operative pain following spine surgery: one approach     using Patient Controlled Analgesia (PCA) devices to deliver opioid analgesics, and the other     approach using EXPAREL® infiltration at the site of surgery and nurse-administered opioid     analgesics.   "
15951|NCT03076697|"     To validate new screening instruments for eye disease, increase eye care access in     underserved communities, and provide a scientifically implemented method to set up programs     for eye disease screening.   "
15952|NCT03076684|"     Increased stiffening of the heart and blood vessels is a predictor of heart disease.     Stiffening has been found to be greater in women than men, which puts women with poor blood     sugar control at a greater risk for heart disease than men. In women only, a molecule in the     blood called uric acid can be elevated due to diets high in fructose consumption and it is     thought to be a cause of heart and vessel stiffening. From previous research, we have found     that restricting fructose in the diet lowers uric acid more in women than men. There is also     a drug that can be used to lower uric acid. These findings suggest a potential approach to     decrease vessel and heart stiffness in women. The present study will investigate fructose     restriction in the diet and drug treatment to lower uric acid in the blood and its effects on     heart disease risk in women compared to men.   "
15953|NCT03076671|"     This is a two-center (University of Colorado, University of California San Francisco)     community-based comparative effectiveness study of outpatient palliative care for Parkinson's     disease (PD) and related disorders (progressive supranuclear palsy (PSP), corticobasal     degeneration (CBD), multiple systems atrophy (MSA), Lewy Body Dementia (LBD). It will utilize     a randomized stepped-wedge design to compare patient and caregiver outcomes between usual     care in the community versus usual care augmented by palliative training and telemedicine     support to provide other resources (e.g. social work).   "
15987|NCT03076229|"     The purpose of this study is to evaluate the effectiveness of relationship education (RE) for     individuals and couples participating in Project Harmony.   "
15988|NCT03076216|"     The purpose of this research study is to investigate the safety of an active implantable     (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer,     who are already receiving standard chemotherapy. OncoSil™, is an experimental treatment. This     means that it is not an approved treatment for pancreatic cancer anywhere in the world at     this time.      OncoSil™, carries the active treatment radioactive Phosphorous (32P) inside inactive     silicon particles. These particles are tiny, and range in size from 28 to 32 micrometres,     which is smaller than the width of a human hair (which typically range in width from 40 to     120 micrometres). Once implanted, the OncoSil™, microparticles will stay in the tumour     permanently.      The purpose of OncoSil™, is to deliver the action of 32P directly into a targeted tumor to     destroy cancer cells. The number of these tiny microparticles inserted into the target tumor     will range from 120 thousand to 2 million, depending on the dose needed for the size of the     tumor.      Patients will be taking part in a single arm open label research study - which means that     everyone in the research study will receive the investigational treatment OncoSil™, plus     their prescribed standard chemotherapy regimen which will be either; Gemcitabine or     gemcitabine + nab-paclitaxel (Abraxane).      Participation in this research study involves a Screening Period, a Treatment Follow Up     Period and a Long Term follow up period. At the first screening visit, every patient will be     asked to sign a consent form to agree to the study procedures, before any assessments are     performed for the study.      The Screening period will require attendance at 2 visits over a 2 week period, the Treatment     Follow Up period will require attendance at assessment visits at the research study center;     weekly for the first 12 weeks, the next visit will occur at week 16, then every 8 weeks after     that until the End of Study (EOS) visit which will be scheduled once a patient's disease has     progressed.      The total number of visits patients will need to attend will depend on how long it takes for     their disease to progress.      The following assessments will be performed at all of the research study visits; Weight,     current medications, , Quality of Life questionnaires, pain evaluation, Karnofsky performance     status, blood sample, (Eastern Cooperative Oncology Group (ECOG) performance status, adverse     events.      The following assessments or procedures will take place at some of the study visits ( 1 or     more): Informed consent, medical history, height, physical exam, Vital signs (blood pressure,     heart rate, body temperature), tumor marker blood test, clotting factor blood test, pregnancy     test, CT (computed tomography) scan - every 8 weeks, Bremsstrahlung Scan (2 only) The     implantation of OncoSil™ will be completed in the endoscopy suite of the hospital.     Implantation will only occur once during the treatment period, and once implanted, the device     cannot be removed.      A procedure called endoscopic ultrasound will be used to implant the microparticles.     Endoscopic ultrasound is a standard procedure performed by a trained doctor. An endoscopic     ultrasound involves a long flexible, fibre optic tube being passed from the mouth, down the     oesophagus (food tube or gullet) and close to the pancreas while the patient is sedated. This     allows the specialist doctor to view the pancreas and enables them to implant the OncoSil     microparticles via a fine needle directly into the target tumor. The implantation procedure     will be recorded and photographs taken of the target tumor and inside the stomach. The     recording and photographic images will be identified only by the patient's research study     identification number.      After the procedure, there will be a 4 hour observation period to ensure that the patient is     feeling fine and safe to go home.      After the patients target tumor shows progression on imaging, their will be an end of study     visit and then the Long Term follow up period will be conducted. The Long Term Follow up does     not require the patient to return to the research study site, it is done via telephone     contact from the site with the patient or review of the patient's medical records by site     staff every 8 weeks for a maximum of up to 30 months.   "
15956|NCT03076632|"     -  People with cervical spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS)          have reduced connections in the nerve circuits between the brain and the hands.          Activating spared nerve circuits is one potential way to improve recovery.        -  The investigators are testing different combinations of physical wrist and hand          movements paired with magnetic brain stimulation and electrical spinal cord or nerve          stimulation to see the effects on nerve transmission to hand muscles.        -  This is a preliminary study. This study is testing for temporary changes in nerve          transmission to hand muscles. There is no expectation of long-term benefit from this          study. If temporary changes are seen in this study, then future studies would focus on          how to prolong that effect.   "
15957|NCT03076619|"     Toxemia of pregnancy is a recognized entity for over 2000 years with its known complications     and fatality. Nowadays, a most accepted terminology for the following defined syndrome is     hypertensive disorders in pregnancy given by American College of Obstetrics and Gynecology.     It is an important cause of maternal and fetal morbidity and mortality. Pregnancy induced     hypertension (PIH) was classified as gestational hypertension, preeclampsia, severe     preeclampsia and eclampsia. PIH is a hypertensive disorder in pregnancy that occurs after 20     weeks of pregnancy in the absence of other causes of elevated blood pressure (BP) (BP >140/90     mmHg measured two times with at least of 4 hour interval) in combination with generalized     edema and/or proteinuria (>300 mg per 24 hrs). When there is significant proteinuria it is     termed as preeclampsia; seizure or coma as a consequence of PIH is termed as eclampsia.     Preeclampsia was classified into mild and severe preeclampsia.      Mild eclampsia—BP >140/90 mmHg, proteinuria+, and/or mild edema of legs, Severe     preeclampsia—BP >160/110 mmHg,proteinuria++ or ++++, headache, cerebral or visual     disturbances, epigastric pain, impaired liver function tests and increase in serum     creatinine.      Proteinuria was tested using dipstick method as +=0.3 gm/L, ++=1 gm/L, and +++=3 gm/L.      The pathological changes of this disease appear to be related to vascular endothelial     dysfunction and its consequences (generalized vasospasm and capillary leak). Ocular     involvement is common in PIH.Common symptoms are blurring of vision, photopsia, scotomas and     diplopia. Visual symptoms may be the precursor of seizures.Progression of retinal changes     correlates with progression of PIH and also with the fetal mortality due to similar vascular     ischemic changes in placenta.Vasospastic manifestations are reversible and the retinal     vessels rapidly return to normal after delivery. Ophthalmoscope should be rated next to the     sphygmomanometer as an instrument of diagnostic importance in cases of PIH. Ophthalmoscopy     does not only helps in diagnosing the disease but repeated observations assist in assessing     the severity, progress of disease, response to treatment if any and ultimate outcome or     prognosis.   "
15959|NCT03076593|"     GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an     early stage investigation that surveys older adults who present to the Emergency Department     for any illness to determine the feasibility of an Emergency Department (ED)-based     multidisciplinary intervention for preventing recurrent falls in older adults. In this     observational study, older adults will be approached during routine clinical care in the ED     and asked about prior falls, prior experiences having falls treated in the inpatient and     outpatient setting, and the investigators will solicit feedback on potential improvement to     care in the ED setting for falls.   "
15960|NCT03076580|"     This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine     genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis.   "
15962|NCT03076554|"     Background:      Thymoma and thymic carcinoma are cancers originating in the thymus gland. Platinum-based     chemotherapy is standard treatment for them. But not uncommonly, the disease returns and     people need more treatment to keep the cancer from growing. The drug Avelumab could help the     immune system fight cancer.      Objective:      To test if avelumab is safe and well-tolerated, and is effective in treating relapsed or     refractory thymoma and thymic carcinoma.      Eligibility:      People ages 18 and older with thymoma or thymic carcinoma that has returned or progressed     after platinum-containing chemotherapy      Design:      Participants will be screened with:        -  Blood, urine, and heart tests        -  Scan: They lie in a machine that takes pictures of the body.        -  Physical exam        -  Medical history        -  Biopsy: a needle removes a piece of tumor. Samples can be from a previous procedure,          although it is desirable to undergo a new biopsy.      Participants will have treatment in 2-week cycles. They will continue until the side effects     are not tolerable or their disease gets worse.      Visits at the following time points are required per protocol:        -  Every 2 weeks: Participants will get avelumab by infusion in a vein (IV). They will get          diphenhydramine (benadryl) and acetaminophen (tylenol) by mouth or IV before receiving          avelumab to decrease the chances of developing a reaction to avelumab. They will have          blood, urine, and heart tests periodically.        -  Cycles 4 and 7, then every 6 weeks: Scans will be performed to look for shrinkage or          growth of tumor.        -  Cycle 4: Participants will be offered a chance to undergo a biopsy.        -  2 4 weeks after stopping treatment: Blood, urine, and heart tests will be performed.          Participants might undergo a scan.        -  10 weeks after stopping treatment: Blood, urine, and heart tests.        -  About 6 months after stopping treatment, then every 3 months: Participants will have          scans andcan allow genetic testing on their blood and tissue samples.   "
15963|NCT03076541|"     Periodic leg movements during sleep is associated with microarousals and a stimulation of the     sympathetic nervous system. The knowledge of this autonomic activation may help understanding     the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the     relationship between periodic leg movements severity, age, gender, electromyographic power     and heart rate response associated with periodic leg movements. Drug-free patients diagnosed     with periodic leg movements were included. Clinical data and 24-h polysomnography recordings     were analyzed.   "
15964|NCT03076528|"     Among patients with diabetes 35% suffer from chronic renal disease and may require dialysis     or kidney replacement over time. Furthermore, in diabetics with end stage renal disease     (ESRD) that require dialysis, the risk of foot complications and amputation is even more     common, expensive, and devastating. Interestingly, even though incidence of foot ulcers in     patients with dialysis has been reported to be same as with patients with history of foot     ulcers; dialysis patients have significantly higher rate of foot amputation.      The goal of this research is to incorporate an innovative virtually supervised non-weight     bearing exercise in patients undergoing dialysis to reduce risk of fall and foot ulceration     by enhancing lower extremity blood flow, joint perception and joint mobility.      Diabetic patients on hemodialysis at Hamad Medical Company will be recruited and will be     randomized to either intervention (IG) or control (CG) group and followed for 6 months. The     intervention group will take part in a 4-week non-weight bearing exercise program twice per     week at the hemodialysis clinic under the supervision of a qualified research staff member.     This intervention includes interactive game-based exercises including repetitive ankle and     foot movements. Wearable sensors will provide real-time visual/auditory feedback from foot     and ankle position and allowed perception of motor-errors during each motor-action. The     control group will be instructed to complete a supervised foot and ankle exercise without     using sensor technology. Changes in balance, gait, and physical activity, incidence of foot     problems will be compared pre- and post-intervention. In addition, the incident of falls,     foot ulcers, and limb amputation up to 6 months post intervention will be documented.     Investigators hypothesize that patients receiving sensor-based exercises will benefit more     compared to group receiving conventional non-technology training in terms of improving     functional performance and reducing incidence of foot problems, falls, and limb amputation.   "
15965|NCT03076515|"     This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio     between treatment and control groups will be 1:1, stratified by center and use of preventive     medications.   "
15966|NCT03076502|"     This study aims to evaluate the role of ct-DNA, PVT1 and reactive oxygen species (ROS) as     biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and     hepatobiliary pancreatic cancer.   "
16035|NCT03075592|"     This study plans to directly address the problem of post-ERCP pancreatitis to gauge the     various factors involved in its development and genetic variability in the immune response to     an isolated pancreatic insult. In addition, the investigators hope to study markers of the     early immune response to this injury and to develop a risk-assessment model.   "
15967|NCT03076489|"     This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the     filling of two on-line questionnaires.      The first visit to the University-Hospital of Rennes, during which a blood sample will be     taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting     energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation     Unit.      During this visit, the volunteers will also have to bring a sample of urine and faeces     previously collected at home.      The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on     photos) will have to be completed by the volunteers between the first and the second visit to     the University-Hospital.      Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on     the Neurinfo platform, during which they will be subjected to a cognitive two-choice test     based on food and drink pictures, during fMRI. Before and after the fMRI session, an     assessment of the state of hunger, thirst, and general status of the volunteer will be     carried out using a numerical scale ranging from 1 to 10.   "
16040|NCT03075527|"     This research study is studying a pair of immunotherapies as a possible treatment for     malignant pleural mesothelioma.      The drugs involved in this study are:        -  Durvalumab        -  Tremelimumab   "
15968|NCT03076476|"     Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels)     supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty).     Traditionally, stents are constructed from metal and are permanent. However, newer stents are     being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over     time leaving no permanent implant. New data has suggested that these scaffolds appear to     reduce recurrent angina and may alter the blood flow down the artery. However, it is not     known whether this is due to the scaffolds themselves or the way the scaffolds are inserted.     In this study we hope to measure the blood flow to the heart and assess changes in that flow     during stent and scaffold insertion. It is also important to know whether these effects are     durable and thus, a cohort of patients will return at 3-months to be restudied. These data     are important to help us understand why blood flow is affected by stent/scaffold selection or     device implantation technique and whether this results in better long-term outcomes.   "
15969|NCT03076463|"     The aim of this is study is to evaluate the long-term effects of grape polyphenols in the     modulation of markers of metabolic syndrome. Most of the previous works about polyphenols     have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a     consequence, an important amount of dietary polyphenols, the so-called non-extractable     polyphenols are ignored. In contrast, the effect of both extractable and non-extractable     polyphenols will be considered in this study. Also, studies on the long-term effect of grape     polyphenol on markers of metabolic syndrome have been mostly conducted in animals, so     clinical trials on this topic are needed.   "
15970|NCT03076450|"     Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC)     adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve     real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective     lung recruitment.   "
15971|NCT03076437|"     Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be     infused back to patients with B cell malignancies, including lymphoma and leukemia. The     patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for adverse     events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.      Objectives:      To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for     patients with B cell malignancies.      Eligibility:      Patients between 1 and 80 years of age, who have relapsed or refractory CD19-expressing     B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.      Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria     are eligible to participate.      Patients must have adequate organ functions.      Design:      Peripheral blood from patients will be collected for isolation of peripheral blood     mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector     encoding anti-CD19 CAR containing a CD28 or 4-1BB and a CD3 zeta as costimulatory domains.      Patients will receive a lymphodepleting preconditioning regimen to prepare their immune     system to accept modified T cells.      Patients will receive an infusion of their own modified T cells. They will remain in the     hospital to be monitored for adverse events until they have recovered from the treatment.      Patients will have frequent follow-up visits to monitor the persistence of modified T cells     and efficacy of the treatment.   "
15972|NCT03076424|"     The purpose of this study is to investigate a persons dietary intake and its effect on the     gut microbiome and the association of those two variables on weight and glucoregulation.     Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin,     c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2)     with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean     controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to     investigate the association with diet, microbiome and weight/glucoregulation.   "
15973|NCT03076411|"     This non-interventional, observational study investigates the course of symptoms in patients     with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid     hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal     Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was     performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures     included recording of AEs and physical examination as well as measurement of vital signs. The     aim was to observe 100 patients during the course of this non-interventional study.   "
15974|NCT03076398|"     Normally, anaesthesia personnel make a record patients' information during the surgical     procedure. Pre and post-operatively, they visit patients to make sure that their customers     are well informed regarding the whole process and satisfied with the service as well as any     complications that might be existed.      The investigators would like to develop an anaesthesia electronic medical record at the point     of care. The objectives are to record peri-operative patients' information in a real-time     fashion, manage all administrative tasks as annual reports, and operate data as search engine     for research and educational purpose.   "
15975|NCT03076385|"     This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in     healthy adult subjects.   "
15976|NCT03076372|"     MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on     cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1     open-label study of MM-310 in patients with solid tumors. In the first part of the study,     MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established.     After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in     combination with other therapies will be assessed.   "
15977|NCT03076359|"     The overall goal of this project is to adapt and assess the impact of a traditional healer     training program/intervention on the adherence, retention, and viral load of HIV infected     patients newly initiated on anti-retroviral therapy (ART) in rural Mozambique.   "
15978|NCT03076346|"     Clozapine has consistently shown to be a superior drug for psychosis in patients who do not     respond to other treatments, but its mechanism of action remains unknown. The overall goal of     this study is to examine the functional neural circuitry that underlies successful treatment     with clozapine, which may lead to the identification of biomarkers that will allow for more     efficient use of clozapine, as well as additional treatment targets for patients with     refractory illness.   "
15979|NCT03076333|"     Purpose: To assess the utility of PET/MR in assessing response to neoadjuvant radiation     therapy in the treatment of high grade sarcomas.      Participants: Adult patients with potentially curable high grade sarcomas that are being     treated at UNC with neoadjuvant radiation therapy followed by potentially curative surgical     resection.      Procedures (methods): Patients who are being treated for potentially curable high grade     sarcomas with neoadjuvant radiation therapy followed by surgical resection undergo     pre-treatment, mid-treatment, and post-treatment PET/MR and the response to treatment is     assessed by evaluating change in size and FDG avidity. Patients then undergo curative intent     resection and are followed. Their pathology is reviewed for treatment affect as is assessed     by percent necrosis, size, and resection margins. Patients are followed and assessed for     recurrence.   "
15980|NCT03076320|"     Acne vulgaris is a complex skin disorder involving multiple abnormalities of the     pilosebaceous unit. Acne is the most common skin disease during puberty and worsens     throughout adolescence. However, epidemiological studies suggest that acne can arise at any     age, most frequently affecting individuals between puberty and 30 years of age, with 79%-95%     of subjects aged between 16 years and 18 years and 80% of subjects between puberty and 30     years of age. Acne is considered the main reason for consultation with the dermatologist in     institutional and private clinical practice.      Clinical features include seborrhoea, non-inflammatory lesions, inflammatory lesions and     various degrees of scarring. There are many classifications of acne and scarring severity.     Moderate to severe acne is about 15-20%.      Facial acne scarring affects both sexes equally and occurs to some degree in up to 95% of     cases. There is a significant correlation between the initial acne grade and the overall     severity of scarring at all sites and in both sexes. This would suggest that treatment aimed     at reducing the severity of acne might reduce the incidence of scarring. Both superficial     inflammatory acne lesions as well as deep nodular lesions seem capable of producing scars.      Conventional therapies recommended for the treatment of acne vulgaris include retinoids,     benzoyl peroxide (BPO), antibiotics, and hormonal therapy. Combination therapy using agents     with complementary mechanisms provides the opportunity to target multiple pathogenetic causes     of acne vulgaris.      The combination in gel with 0.1% adapalene and 2.5% BPO is a once-daily treatment of acne     vulgaris. In several double- blind, randomized controlled trials (RCTs), the Adapalene-BPO     (A-BPO) combination therapy applied once daily for 12 weeks significantly reduced the number     of both inflammatory and non-inflammatory lesions in subjects with moderate acne vulgaris. In     Mexico there is an available commercial product of this combination (Effezel®; Galderma). The     limitation of this topical therapy is the low tolerability by patients as they can experiment     several levels of irritation, erythema, dryness, desquamation, burning, and itching), and     patients are advised to expect these side effects, which contribute to discontinue therapy if     it becomes severe.      On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone or pirfenidone (PFD) is a wide-spectrum     antifibrotic drug that modulates diverse cytokines action, involving TGF-β, TNF-α, epidermal     growth factor, platelet-derived growth factor, VEGF, IGF-1, fibroblast growth factor,     interferon-γ, interleukin (IL)-1, IL-6, and IL-8 and it has shown promising effects in vitro     and in vivo settings. Also, PFD has proven effective in the prevention and regression of     pulmonary fibrosis, peritoneal sclerosis, hepatic cirrhosis, uterine fibromyoma, left     ventricular fibrosis, renal interstitial fibrosis, and breast capsular contracture in     experimental models. A recently open phase II clinical trial evaluated the therapeutic use of     PFD gel in localized scleroderma. Results showed it acts on both the inflammatory and the     fibrotic phases.      The other component of Zaxcell is modified-diallyl disulfide oxide (M-DDO) an antimicrobial     and antiseptic agent, which has been proved in patients with chronic diabetic ulcer as a     potent germicide and has show to increase the beneficial effect of PFD preventing infections,     accelerating and improving ulcer resolution. (Observations not published).      According to this, the investigators believe that Zaxcell (PFD + M-DDO) could play an     important role in the modulation of inflammatory and scarring process in acne. The     investigators hypothesis is that PFD in patients with moderate to severe acne modulates     amplification of the inflammatory response, regulating the inflammasome activation,     macrophage polarization and its activity in regulating the wound healing process of the skin     in an early fashion.      Zaxcell is an innovative gel with a synergetic mode of action that could modulate the     inflammatory response. Furthermore, has antiseptic properties and regulates the process of     wound healing, fibrogenic and scarring process. In vitro and in vivo studies provide an     initial body of evidence on the safety and clinical benefits of PFD, the main component of     Zaxcell as a promising candidate for the treatment of moderate to severe acne.   "
15981|NCT03076307|"     Patients with Parkinson's disease (PD) are known to be affected by subtle cognitive     impairment early in the disease course, mostly in the executive field. Procedural motor     skills, mainly controlled by the basal ganglia associative loop (in particular dorsal caudate     nucleus) (Rodriguez-Oroz et al., 2009), have also been studied in patients with PD (Schnider     et al., 1995; Muslimovic et al., 2007; Terpening et al., 2013). However, the correlation of     dopaminergic 123I-FP-CIT SPECT imaging and cognitive impairment has not been assessed. One     reason is the absence of reference values for striatal uptake until recently. Last year, the     investigators established local uptake reference values for DAT imaging based on a large     cohort of subjects with non-degenerative conditions (Nicastro et al., 2016) and can therefore     use these values to precisely assess uptake loss in patients with PD.      With the present study, the investigators expect to enroll patients with early PD for whom a     123I-FP-CIT SPECT has been previously performed in the center. Subjects will perform a     specific motor task based on mirror-drawing of star-shaped figures. This will be done by     inverting the direction of horizontal/vertical computer mouse movements on the screen. Speed     and error rates will be assessed for patients as well as healthy control subjects.     Correlation with striatal SPECT uptake, especially caudate nucleus uptake, will be analyzed     for PD patients. In addition, resting-state EEG will be performed for all subjects. General     medication and dopaminergic drugs in particular, whenever used, will not be discontinued. For     all subjects enrolled in the study, cognitive and neurological examination will be performed.   "
15982|NCT03076294|"     In this study, the investigators wondered whether the association between high frequency     repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and     central approach) is more effective in reducing pain levels and modulation of cortical     activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual     peripheral approach). For this purpose, patients included will be submitted to one session     with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another     active group will have the sequence of interventions exchanged (manual therapy followed by     hf-rTMS) in order to investigate whether this may influence in the final outcomes.   "
15983|NCT03076281|"     This randomized phase II trial studies how well metformin hydrochloride and doxycycline work     in treating patients with head and neck squamous cell carcinoma that can be removed by     surgery. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of     surrounding supportive tissue. Doxycycline may minimize toxic side effects of anti-cancer     therapy. Giving metformin hydrochloride and doxycycline may work better in treating patients     with head and neck squamous cell carcinoma.   "
15984|NCT03076268|"     Treinta Millones de Palabras- Visitas al Hogar (TMP) is designed to intervene upon mothers'     knowledge, beliefs, and behavior, which in turn influences their interaction with their     children, impacting children's development. The investigators will measure change in mothers'     knowledge, beliefs, and behavior during and after intervention, and measure impacts on     children's development across major developmental domains. Specifically, the investigators     will measure mothers'        1. Knowledge of child language development and the role of parents in that development        2. Beliefs about the malleability of intelligence and their role in shaping their          children's intelligence        3. Interaction with their child, specifically their linguistic input and responsiveness to          their child's communication      Concurrently, the investigators will measure children's        1. Emergent oral language development, in both Spanish and English        2. Social-emotional development        3. Math and spatial reasoning skill development   "
15985|NCT03076255|"     This pilot clinical trial studies how well head and neck maskless immobilization device works     in immobilizing patients with intracranial tumors undergoing radiation therapy. Maskless     immobilization device may help to prevent movement of head during radiation therapy and     immobilize patients with the same accuracy and reliability as the standard thermoplastic mask     routinely used for patients with brain tumors receiving radiation therapy.   "
15986|NCT03076242|"     This is a prospective research registry and prospective genetic testing cohort study. The     goal is to collect personal medical and cancer history data, family cancer data, exposure     history, and biospecimens to support research focused on optimal genetic testing strategies     for men with prostate cancer with the ultimate goal of informing national guidelines focused     on genetic evaluation for prostate cancer.   "
15989|NCT03076203|"     This phase Ib trial studies the side effects and best dose of niraparib when given together     with radium Ra223 dichloride in treating patients with prostate cancer that keeps growing     even when the amount of testosterone in the body is reduced to very low levels and has spread     from the primary site to the bone. Radium Ra 223 dichloride, acts like calcium to target     cancer in the bones and may deliver radiation directly to the bone tumors, limiting damage to     the surrounding normal tissue. Niraparib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Giving radium Ra 223 dichloride and niraparib may work     better in treating patients with hormone-resistant prostate cancer metastatic to the bone.   "
15999|NCT03076073|"     The aim of the current study is to evaluate the Patellar tendon and Achilles tendon     structures among children, adolescents and adults with different weight status. That in order     to improve our understanding on the impact of acute and overused loads on tendon structure;     and, in developing strategies to reduce tendon's injuries following physical exercises.   "
15990|NCT03076190|"     The primary purpose of this study is to determine the feasibility and preliminary efficacy of     a remote, Internet-based, pre-surgical psychoeducational intervention delivered to patients     scheduled for breast cancer surgery (compared to an active control group that receives health     education).      Aim 1: Determine feasibility, satisfaction, and perceived utility of My Surgical Success.      Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the     study (feasibility). Of those who complete My Surgical Success we expect 80% satisfaction     ratings, and 80% perceived utility of the information learned.      Aim 2: Determine group differences in within-subject pain catastrophizing scores (baseline -     0 to 48 hours before surgery).      Hypothesis 2: My Surgical Success participants evidence greater reduction in pain     catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE     Control group.      Aim 3: Determine group differences in time to post-surgical pain and opioid cessation.      Hypothesis 3: My Surgical Success participants will evidence quicker time to post-surgical     pain and opioid cessation compared to the HE Control Group.      Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS     Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Sleep Related     Impairment, Anger, Fatigue, Global, Distress, and Pain Intensity).      Hypothesis 4: My Surgical Success participants will evidence greater post-surgical function     and lower pain related interference compared to the HE Control Group.      The goal of this research is to advance our understanding regarding the feasibility and     effectiveness of remote psychoeducation interventions and impact on post-surgical outcomes.   "
15991|NCT03076177|"     Purpose of our study is to evaluate effectiveness of Kinesio Taping method for knee     osteoarthritis. Using simple concealed randomization procedure to form two groups (kinesio     taping and control-nonspecific taping) of 100 knee osteoarthritis patients in each. 1 month     all patients (depending on the group they will be allocated to) will receive either kinesio     taping applications or non-specific taping: 4 applications per subject. Three times: before     taping, after a month with tapes, and after 1 month without tapes evaluation of knee     function, mobility, quality of life will be evaluated, including clinical examination of knee     joint, measurements of knee flexion and extension by goniometer, circumference of leg over     the knee, in ½ of thigh and in ½ of calf (to evaluate edema); pain will be evaluated by     questionnaire, patella tendon algometry; force of calf flexors and extensors will be     evaluated using Lovett manual muscle testing scale, goniometry for knee flexion/extension;     for mobility, knee function, life quality evaluations - 10 Meter Walk , Five Times Sit to     Stand Tests will be performed, Knee injury and Osteoarthritis Outcome Score (KOOS) and     Medical Outcomes Study Short Form 36 2 version (SF-36 2v) questionnaires will be used. Also     data about the need of analgesic medicament will be collected from subjects.   "
15992|NCT03076164|"     The purpose of this study is to determine the safety, tolerability and overall response rate     of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent     lung adenocarcinoma that cannot be treated with curative intent.   "
15993|NCT03076151|"     Tacrolimus is a calcineurin inhibitor widely used for the prevention of allograft rejection     in solid organ and bone marrow transplantation. It is characterized by a narrow therapeutic     index and large inter-individual pharmacokinetic variability. Adoport® is an     immediate-release formulation of tacrolimus, to be administered twice daily. Because of a     narrow therapeutic window and a better correlation between pre-dose level and effects than     between dose and effect, therapeutic drug monitoring (TDM) based on trough whole blood     tacrolimus concentrations is recommended for Adoport®. TDM helps to minimize the risk of     acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser     extent, neurotoxicity).      As reported in a consensus document from a consortium of European experts on tacrolimus TDM,     the interdose area-under-the curve (AUC0-12h) is expected to be the best marker of tacrolimus     exposure. However, tacrolimus monitoring based on full AUC0-12h is difficult to set up in     routine, due to clinical constraints and the necessity of multiple samples. Calculation of     the AUC0-12h using Bayesian estimation and a limited sampling strategy, i.e. a few blood     samples collected during the early phase post-dose would represent an elegant solution, as     already done for other tacrolimus formulations.      Furthermore, the pharmacokinetics (PK) of tacrolimus is influenced by a single nucleotide     polymorphism within intron 3 of cytochrome P450 3A5 (CYP3A5). Patients who carry at least one     CYP3A5*1 allele are considered to be CYP3A5 expressors (about 12% of the Caucasian     population, Hapmap project) and thus require a 1.5 to 2-fold higher starting dose than     CYP3A5*3/*3 carriers to reach the predefined target exposure early after transplantation.     Although this polymorphism showed no impact on the performance of the Bayesian estimators     previously developed for other tacrolimus formulation, the patient status for CYP3A5*3 will     be considered in this pharmacokinetic study as a potential covariate in, or confounding     factor of, the PK model. Specifically, owing to a 12% frequency in the White European     population, about 4 patients carriers of the CYP3A5*1 allele are expected in this study; the     performance of the PK model and Bayesian estimator developed will be specifically evaluated     in this subgroup.   "
15994|NCT03076138|"     The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone     substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial     growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and     acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.   "
15995|NCT03076125|"     The purpose of this study is to test the efficacy of the Stroke Counseling for Risk Reduction     (SCORRE) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle     behavior change to reduce stroke risk in young adult African Americans.   "
15996|NCT03076112|"     The objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on     glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus,     whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of     other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric     acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition     including fat and muscle mass with volume status.   "
15997|NCT03076099|"     Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure     in patients undergoing brain arteriovenous malformation embolization. The patients were     randomized allocated to either Dexmedetomidine group or Control group. Patients in     Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will     receive normal saline. Post-operative anti-hypertensive drug, Visual analogue     score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and     adverse events were recorded.   "
15998|NCT03076086|"     The aim of this study is to validate two new biomarkers in sputum samples. These are PiP3     (phosphoinositolphospat ) and phosphor proteins, representing important proteins within     inflammatory situations of the lung.   "
16105|NCT03074682|"     The aim of the study is to determine if a new device is more effective in fluid     administration than devices currently used when resuscitating pediatric patients in septic     shock. This study will take place in a simulation lab setting and will not include the use of     patients.   "
16000|NCT03076060|"     Ketogenesis is a physiologic phenomenon due to starvation or ketogenic diet (KD), a drastic     restricted carbohydrate dietary regimen that induces lipid metabolism and ketone body (KB)     synthesis. We followed, in a dietician clinical setting, a group of migraineurs who randomly     received a one-month prescription of experimental diet, followed by a one-month of     carbohydrate progressive reintroduction, then another one-month of experimental diet,     followed by a one-month of carbohydrate progressive reintroduction. Experimental diets are a     very-low calorie KD, or an isocaloric non-ketogenic diet.      Aim of our study is verify if during ketogenesis migraine improves.   "
16001|NCT03076047|"     To understand if a progressive increase in end-tidal carbon dioxide (CO2) levels are     heralding respiratory difficulties before desaturation measured from capnography in     obstructive sleep apnea patients.   "
16002|NCT03076034|"     The objective of this study is to determine whether a new minimally invasive method for in     vivo measurement of cortical bone tissue properties can identify those who are at risk for     fragility fractures of the hip and radius. The investigators hypothesis is that women with     fragility fractures of the hip and radius have altered cortical bone tissue properties     compared to non-fracture controls independent of standard clinical tests, such as bone     mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).   "
16003|NCT03076021|"     Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases     CYP2D6 activity in adolescent patients.   "
16004|NCT03076008|"     The investigators plan to perform a prospective observational cohort study of patients     undergoing MPFL reconstruction for the treatment of episodic patellar instability in the     absence of significant degenerative disease. The investigators will follow these study     subjects for a minimum of two years to monitor their functional and clinical outcome.   "
16005|NCT03075995|"     Food can make a big difference on the bioavailability of lapatinib in breast cancer     patients,and fatty food can increase the lapatinib bioavailability.By examine the steady     blood drug concentration in the same individual at different treatment mode for     lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with     fatty food.   "
16006|NCT03075969|"     The objective of this study is to test the scale structure, reliability, validity and     responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients     diagnosed with CML, and to investigate longitudinal relationship between satisfaction with     information provision and QoL outcomes.   "
16007|NCT03075956|"     Estetrol (E4) is being developed in two indications supporting women health care: first E4 is     combined with a progestin, [drospirenone (DRSP)] and is used as a new combined oral     contraceptive (COC) for the prevention of pregnancy and secondly, E4 is used alone as new     hormone replacement therapy (HRT) for the treatment of menopause related symptoms.      The current clinical trial is designed to collect more detailed information about the PK     profile, safety and tolerability of different dosages of E4, given orally as a solid tablet.   "
16008|NCT03075943|"     The overall goal of this study is to investigate the effects of a daily dietary supplement of     brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion     in overweight prediabetic men and women in association with a moderate weight loss     intervention.   "
16009|NCT03075930|"     This is a single centre prospective data registry. In this study atrial conduction     characteristics of extended surface Electrocardiograms (esECG), biomarkers and genetic     analysis will be performed before ablation, before discharge and 3 months after catheter     ablation of atrial fibrillation (AF) and compared to routine clinical follow-up data.      The objective of this registry is to establish a data registry of patients undergoing     ablation of AF. Supplementary to the routine clinical diagnostic an esECG and an analysis of     biomarkers will be performed and compared to clinical and outcome data.   "
16010|NCT03075917|"     Allergic rhinitis is a common condition that affects adults as well as children and     adolescents, often with impaired quality of life. Patients often report a poor level of     satisfaction with the effectiveness of their treatment and are always looking for more drug     combinations to improve their symptom. Several tools exist for assessing control of allergic     rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008,     resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in     patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5     to 11 years old.   "
16011|NCT03075904|"     This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK),     pharmacodynamics (PD), immunogenicity, and effects on pemphigus disease activity markers of     intravenous (IV) SYNT001.   "
16012|NCT03075891|"     The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream     associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical     cream associated with Placebo in the treatment of severe Rosacea.   "
16013|NCT03075878|"     This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK),     pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia     (WAIHA) disease activity markers of intravenous (IV) SYNT001.   "
16984|NCT03063203|"     In this study, the investigators seek to determine whether decitabine therapy can improve     outcomes, specifically overall survival this selected subset of acute myeloid leukemia (AML)     patients with the poorest prognosis based on refractoriness to induction treatment and high     risk genetic mutations.   "
16014|NCT03075865|"     OmniMax MMF system was designed as a device with faster application/removal time, less     mucosal tissue overgrowth over the plates and screws, better tolerance for placement over     prolong periods of time, better patient hygiene and a lower risk for further treatments     secondary to root damage from the insertion of the screws, compared to the standard of care     for maxillo-mandibular fixation and other hybrid systems. This clinical trial intends to     highlight the clinical benefits of the OmniMax MMF system applied to patients undergoing     repair of uncomplicated mandibular fracture(s) for whom OmniMax MMF system is used as a     single mean for maxillo-mandibular fixation.   "
16015|NCT03075852|"     Prospective, cross-sectional, observational study investigating a three dimensional heads up     display for retinal surgery and comparing its outcomes and ease of use with the standard     operative microscope.   "
16016|NCT03075839|"     This pilot study will investigate within-person changes in smoking behavior when current     adult smokers are systematically switched from smoking menthol cigarettes to non-menthol     cigarettes.   "
16106|NCT03074669|"     The main objective of this study is to test the effectiveness of an Internet-delivered     Acceptance and Commitment Therapy (ACT) program in reducing anxiety symptoms.   "
16017|NCT03075826|"     -  This is an open label single-arm, single-institution stud to evaluate the efficacy and          safety of SGI-110 in Philadelphia chromosome negative (Ph-) Myeloproliferative Neoplasms          (MPN) (excluding PV, ET and primary/secondary myelofibrosis). The study will enroll          approximately 50 patients at the Weill Cornell Medical College.        -  Enrollment onto this clinical study is expected to be completed in approximately 36          months. The total study duration will depend on individual response, evidence of disease          progression and tolerance. Participants will be followed monthly for six months after          removal from study or until death, whichever occurs first.      Key eligibility:        -  Confirmed diagnosis of Ph- MPN and had        -  No chemotherapy or radiation treatment within 2 weeks prior to study entry.        -  Subjects meet other protocol-defined criteria related to baseline screening procedures.   "
16018|NCT03075813|"     The purpose of this quality improvement study is to measure the effectiveness of surveillance     using optimized statistical process control (SPC) methods and feedback on rates of surgical     site infection (SSI) compared to traditional surveillance and feedback.      The primary objective is to determine if hospital clusters randomized to receive feedback     from optimized SPC surveillance methods collectively have lower rates of SSI compared to     hospital clusters randomized to receiving feedback from traditional surveillance methods.     Secondary objectives are 1) to estimate and compare the number of signals identified using     optimized SPC methods and traditional surveillance methods; 2) to estimate and compare the     time and effort required to investigate signals generated using optimized SPC methods and     traditional surveillance methods; and 3) to estimate the number and proportion of     false-positive signals identified using optimized SPC methods and traditional surveillance     methods.      The Early 2RIS study will be a prospective, multicenter cluster randomized controlled trial     using stepped wedge design. The active component of the quality improvement study will be     performed in 29 DICON hospitals over three years, from March 2017 through February 2020.     Clusters randomized to intervention will receive feedback on increasing rates of SSI     identified through optimized SPC methods. This intervention is expected to decrease the     subsequent rate of SSIs by closing the feedback loop on SSI outcomes.      Participating study hospitals will all be members of DICON, a network of 43 community     hospitals in North Carolina, South Carolina, Georgia, Florida, and Virginia that provides     community hospitals access to consultative services from infection prevention experts, data     analyses and benchmarking, and educational materials designed by faculty from Duke. This     study is considered part of routine quality improvement measures and a part of previously     established agreements between DICON and the community hospitals. Data flow and communication     are outlined in detail in approved protocols determined to be exempt research by the DUHS     IRB. Briefly, existing clinical data are extracted from participating hospitals' electronic     medical record into discrete files according to DICON specifications. Then a     de-identification process removes direct patient identifiers into a limited dataset.      The majority of data collection will occur through methods already developed and utilized by     study hospitals. In brief, each hospital routinely submits limited datasets to the DICON     Surgical Surveillance Database, including the following variables: hospital, type of     procedure, patient identifier, date of procedure, age, sex, surgeon identifier, start/stop     times, ASA score, wound class, risk index, SSI (Yes/No), date of infection, type of SSI,     location at diagnosis and organism. No identifiable patient or surgeon data are transmitted     to the DICON Surgical Database. Data definitions and data collection methods are standardized     across DICON hospitals. Following signal adjudication, additional data will be collected in a     REDCap database to document actions and rationale.   "
16019|NCT03075800|"     Integrating Illness Management and Recovery (IMR) into Assertive Community Treatment (ACT)     has great promise for improving the symptomatic, functional, and recovery outcomes for people     with Serious Mental Illness (SMI), especially those individuals who have the greatest needs.     In addition to these positive consumer outcomes, system benefits may also accrue due to more     rapid graduation of consumers from ACT (with IMR) programs to less intensive levels of care.     However, before these benefits can be realized, research and development are needed to design     and pilot test a treatment manual that is feasible and acceptable to consumers and staff for     integrating IMR and ACT.   "
16020|NCT03075787|"     Obstructive sleep apnea is often associated with microarousals and a stimulation of the     sympathetic nervous system. The knowledge of this autonomic activation may help understanding     the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the     relationship between obstructive sleep apnea severity, age, gender and heart rate response     associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep     apneas were included. Clinical data and 24-h polysomnography recordings were analyzed.   "
16021|NCT03075774|"     Multicenter prospective observational study, involving all adult patients who underwent     cardiac surgery with extracorporeal circulation   "
16022|NCT03075761|"     'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential     effectiveness of a personal fitness tracker to improve adherence to an activity regimen     following an initial acute DVT in children.   "
16023|NCT03075748|"     The outcomes from prior clinical evaluation of the study device, including successfully     treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at     one year, demonstrate the potential benefits of the device. When contrasted with open     repair's significant complication rates and branch fenestrated device's significant anatomic     and logistic limitations, the potential risk of the proposed novel graft does not outweigh     the potential benefit of widened anatomic availability and improved patency rates. Given the     potential benefits, the investigators feel that it is justified to expose the target patient     population to the potential risk. The non-clinical testing performed by Medtronic and the     clinical results reported by Sanford Health show adequate safety of the device to support an     early feasibility study.      The investigators would like to perform an early feasibility study under a defined and     controlled protocol to collect prospective preliminary safety and device functionality data.     The investigators believe an early feasibility study is most appropriate for this novel     approach. The limited sample size allows adequate patient data to be collected under a     controlled protocol without exposing a large patient population to the risk associated with a     novel device design.   "
16024|NCT03075735|"     PROREPAIR is a prospective multicenter observational cohort study of unselected patients with     metastatic Castration Resistant Prostate Cancer (mCRPC) with unknown germline mutational     status at study entry and who are candidates to start 1st line treatment with any approved     survival-prolonging agent.      The study aims to evaluate the impact of aberrations in DNA-repair genes,(BRCA1, BRCA2, ATM     and PALB2 and other genes) on cause-specific survival from the diagnosis of the metastatic     castration resistant status and other outcomes.   "
16037|NCT03075566|"     Atherosclerosis is a chronic inflammatory condition, which is associated by the involvement     of several pathological events, and alteration in the serum levels of pro- and     anti-inflammatory, and lipid markers.      The investigators evaluated the contribution of serum biomarkers levels to the pathogenesis     of coronary artery disease, namely their association with risk factors, clinical     presentation, extent and severity of atherosclerotic changes accompanying coronary artery     disease.   "
16038|NCT03075553|"     This phase II trial studies how well nivolumab works in treating patients with peripheral     T-cell lymphoma that has come back after a period of improvement or that does not respond to     treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different     ways by targeting certain cells.   "
16025|NCT03075722|"     This investigation is designed to evaluate the performance (treatment and leak), comfort     (subjective feedback), stability (subjective feedback, leak) as well as the participant's     overall acceptance of the Saturn mask amongst OSA participants. An important factor in this     investigation will be the testing of our two different seal sizes on the participants (small     and medium size). A total number of 15 participants who currently use nasal or nasal pillow     masks will be recruited for the trial. A subset of participants have been selected based on     their anthropometric measurements collected in previous trials using nasal and nasal pillow     masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this     trial with their consent. All the participants will be recruited by WellSleep, Wellington.      Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will     be collected from the participant during the first visit, the prior 7 days of CPAP usage data     will be downloaded and stored for our analysis. The participant will use the trial device on     their usual CPAP/APAP setting and device for the duration of the trial.      This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the     protocol will be implemented without prior review and approval of the sponsor except where it     may be necessary to eliminate an immediate hazard to a research participant. In such case,     the deviation will be reported to the sponsor as soon as possible.   "
16026|NCT03075709|"     Chronic obstructive pulmonary disease (COPD) has substantial economic and human costs. To     minimize these costs high quality guidelines have been developed. However, development of     guidelines alone rarely results in changes to practice. One method of integrating guidelines     into professional practice is the use of clinical pathways (CPWs).      The investigators are working with local stakeholders to develop CPWs for COPD with the aims     of improving quality of care and guideline adherence while reducing healthcare utilization.     The CPWs will utilize several steps including: standardizing diagnostic training,     implementing and unifying common components of chronic disease care, coordinating the     provision of education and reconditioning programs, and ensuring disease specific care     utilizes and delivers evidence-informed practices. In addition, the investigators have worked     to identify evidence-informed strategies for the implementation of the CPWs. Efforts are     underway to tailor these implementation strategies for the local context.      The investigators will conduct a three-year quantitative health services research project     using an interrupted time series (ITS) design in the form of a multiple baseline approach     with control groups. The CPW will be implemented in two Saskatchewan health regions     (experimental groups) and two health regions will act as controls (control groups). The     experimental and control groups will each contain one urban and one rural health region.      This project is expected to improve quality of life and reduce healthcare utilization. The     project will also provide evidence on the effects of CPWs in both urban and rural settings.     If the pathways are found effective the investigators will work with all stakeholders to     implement similar CPWs for the remaining health regions in the province.   "
16027|NCT03075696|"     This is a Phase I, multicenter, open-label, dose-escalation study designed to evaluate the     safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), RO7082859,     administered by intravenous (IV) infusion, following the pretreatment administration of a     one-time, fixed dose of obinutuzumab. The study is divided in 3 parts: dose escalation (Parts     I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be     used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part     II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose     (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is     defined, to further evaluate the safety, PK and therapeutic activity of RO7082859.   "
16028|NCT03075683|"     The main goal is to study the effect of therapist-guided internet-delivered cognitive     behavioural therapy for insomni comorbid with chronic pain in a clinical sample.   "
16029|NCT03075670|"     This trial is conducted in Europe and the United States of America. The aim of this trial is     to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta     pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.   "
16030|NCT03075657|"     The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep     pattern/quality and circadian rhythm disruption in patients with schizophrenia.   "
16031|NCT03075644|"     This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once     weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in     previously human growth hormone treated Japanese adults with growth hormone deficiency.   "
16032|NCT03075631|"     This study is an ancillary of APPRENTICE. This will be the international based study.   "
16033|NCT03075618|"     The management of acute pancreatitis is mainly based on expert opinions; large randomized     controlled trials are missing and novel therapeutic approaches are considered necessary. This     study will evaluate the current management and outcomes of acute pancreatitis around the     world.   "
16034|NCT03075605|"     This is a prospective case control study that compares the initial immune response with     severity and outcome in patients with acute pancreatitis.   "
16036|NCT03075579|"     Diurnal profiles of markers of the stress system are increasingly recognized as biomarkers of     different kinds of depression and related states. They may also serve as markers of treatment     success. However, this has not yet been studied in attention deficit disorder (ADHD).     Especially, there is a paucity of research into the effect of ADHD medication on the diurnal     profiles of cortisol as marker of the hypothalamic pituitary adrenal (HPA) system and of     amylase as marker of the sympathetic adrenomedullar (SAM) system.      The investigators propose a within subjects design with probands of a narrow age range (seven     to ten years of age, same sex: boys only) in order to get first information about whether     there is an effect of atomoxetine on these diurnal profiles of cortisol and amylase, what     kind of effect it is and whether this effect is related to treatment success. The     investigators control for motor activity by using actometer measurements.   "
16041|NCT03075514|"     Glioblastoma (GB) is the commonest form of brain cancer in adults. Despite current treatment     options including surgery, radiotherapy and chemotherapy, overall survival is poor.     Therefore, other treatment options are being explored and there is increasing interest in the     possibility of using the ketogenic diet (KD), alongside current treatment options.      The KD is a high fat, low carbohydrate diet. This encourages the body to use fat (broken down     to ketones) as its primary energy source, instead of carbohydrate (broken down to glucose, a     type of sugar). KDs have been considered for use in patients with GB as this type of cancer     is thought to use glucose as its main energy supply, which is of short supply in this diet.     Animal studies have shown KDs may make GB more responsive to radiotherapy and chemotherapy     and could improve survival by slowing the cancer's growth. However, clinical studies are     needed in humans to assess any possible benefits.      This trial will see patients randomly assigned to one of two types of KDs; the modified     ketogenic diet (MKD) and the medium chain triglyceride ketogenic diet (MCT). Both diets     follow the same high fat, low carbohydrate principles, with the MCT diet requiring the     patient to take some of the fat as a supplement drink instead of as food. Patients will     follow the diet for 12 weeks initially. The trial will look to enroll newly diagnosed GB     patients, from The Walton Centre NHS Foundation Trust over a 12 month period.      The aim of the trial is to investigate protocol feasibility and patient impact by comparing     two KDs in an NHS setting, with a view to informing future phase III clinical trials.   "
16042|NCT03075501|"     The purpose of the study is to determine how associations between drugs and the places where     they are experienced influence drug seeking, mood and acute drug responses.   "
16043|NCT03075488|"     The study is aimed at evaluating whether ultrasound pre-procedural scan with Accuro may     reduce needle redirections when performing spinal injection in patients with BMI = or > 30 in     orthopedic surgery   "
16044|NCT03075475|"     This randomized controlled trial evaluates the effectiveness of a psychotherapeutic     intervention, the Common Elements Treatment Approach (CETA), to address the mental health     needs of children and adolescents age 8-17 who have been affected by armed conflict in Kachin     State, Myanmar. The 10-12 week talk-based counseling treatment, delivered by community mental     health workers, will be evaluated against a wait-list control group. This project follows on     a recently completed trial of CETA for adult trauma survivors from Myanmar along the     Thai-Myanmar border which found that CETA was acceptable, accessible, and effective in     improving mental health and functioning of adults. The investigators hypothesize that the     intervention will be similarly effective for improving the mental health and functioning of     children and adolescents.   "
16045|NCT03075462|"     Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2     inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR)     inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best     dose of fluzoparib in combination with apatinib and to see how well these two drugs work     together in the treatment of patients with recurrent ovarian cancer or triple negative breast     cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored.     Both dose escalation and dose expansion parts are included in this study.   "
16046|NCT03075449|"     This study will describe the current medical care given to men who discuss their lower     urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the     baseline characteristics of these men, the treatment received, and the practice patterns of     specifically a primary care physician managing these patients.   "
16047|NCT03075436|"     This study is a two-year evaluation investigating the impacts of an enhanced, demand-side     sanitation and hygiene intervention on sustainable adoption of improved water, sanitation,     and hygiene (WASH) practices and mental well-being.   "
16048|NCT03075423|"     SUNNIFORECAST (Sunitinib vs. Nivolumab + Ipilimumab as First line treatment Of REnal cell     CAncer of non-clear cell SubTypes) is a Phase II, randomized, open-label investigator     initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs Sunitinib     monotherapy in subjects with previously untreated and advanced (unresectable or metastatic)     non-clear cell renal cell carcinoma (nccRCC).   "
16049|NCT03075410|"     GSK3036656 is being developed by GSK for the treatment of tuberculosis (TB). This is the FTIH     study for GSK3036656 to evaluate the safety, tolerability and PK of single ascending and     repeat oral doses of GSK3036656 in healthy adult subjects. The results of this study are     intended to be used to identify appropriate and well-tolerated doses of GSK3036656 to be used     in further studies. A food effect assessment will also be undertaken to investigate the     influence of food on the PK of GSK3036656. The study will be conducted in two parts: Part A     (single dose) and Part B (repeat dose). Up to two cohorts will be included in Part A. 9     healthy adult subjects will be included in each cohort. Each cohort will participate in up to     4 treatment (dosing) periods including a food effect treatment period. During each treatment     period, GSK3036656 will be administered to 6 subjects and placebo will be administered to 3     subjects. The starting dose in Part A will be 5 milligrams (mg), and the maximum dose will be     1500 mg. The two cohorts in Part A will be dosed sequentially (i.e., dosing in Cohort 2     starts after dosing in Cohort 1 is completed). Initially, there will be a 14 day wash out     period for individual subjects between each dose level. Study progression to Part B from Part     A will be based on an acceptable safety, tolerability and PK profile in Part A. Part B will     comprise up to 4 cohorts (Cohorts 3, 4, 5, and 6) each containing 10 (8 active: 2 placebo)     healthy adult subjects to examine the safety, tolerability and PK of a repeated daily dose of     GSK3036656 over a period of up to 14 days. Appropriate doses and dose regimens for Part B     will be selected based on available safety, tolerability and PK data from Part A and/or any     preceding repeat dose cohorts from Part B. Dividing the total daily dose into 2 or 3 smaller     doses may be done in both Part A and Part B. Up to 18 subjects will be enrolled into Part A     and up to 40 subjects will be enrolled into Part B. The total duration of the study for each     subject recruited into Part A and Part B will be approximately 12 weeks and 8 weeks,     respectively.   "
16050|NCT03075397|"     The objective of our project is to determine the infected seminal cell types and the     molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa,     using conditions as close as possible to real life, i.e. seminal leukocytes and seminal     plasma from HIV-infected donors and tissue explants   "
16053|NCT03075358|"     Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women     with abnormal uterine bleeding to examine endometrial pathology. The procedure has high     accuracy comparing to conventional fractional curettage. However, it is associated with     significant pain during the procedure. In general, there is no specific recommendation     regarding the proper anesthesia used during the procedure.      The aim of this study is to examine the effect of lidocaine spray for reducing pain during     the endometrial aspiration procedure by comparing it with placebo and no intervention.   "
16054|NCT03075345|"     Obesity is an 'epidemic' within the UK. Individuals living with obseity are at risk of     developing cancer, heart problems and dieing. Furthermore, obesity impacts on psychological     wellbeing via lowered self-efficacy, self-esteem, body image and overall quality of life     (QoL). A pilot randomised controlled trial (RCT) is proposed to investigate the additional     benefit of a psychological intervention alongside treatment as usual (TAU) in a weight     management service. Patients routinely attending an outpatient clinic will be randomised into     TAU with or without additional acceptance and commitment Therapy (ACT) group based-input and     their outcomes monitored over time.   "
16055|NCT03075332|"     The goal of this study was to evaluate the effect of detraining in the components of physical     aptitude of people living with HIV/Aids (PVHA).   "
16056|NCT03075319|"     Total knee arthroplasty (TKA) is recognized as a successful procedure for treating     osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the     degree of knee flexion. Providing more range of motion after TKA impact on the convenience of     daily of life such as climbing stairs, sitting on the floor particularly in Asian cultures     which require a lot of ground activities. Data are limited on the added benefits of     perioperative photograph as motivation for increasing range of motion after TKA.      Half of participants received perioperative photograph as motivation, while the other half     did not after total knee arthroplasty.   "
16057|NCT03075306|"     The prevalence of overweight and obesity in youth with serious emotional disturbance (SED)     exceeds the epidemic levels of overweight and obesity for children in the general population.     Associated cardiovascular (CVD) risk factors such as glucose intolerance, hypertension and     lipid abnormalities frequently already exist in obese children. Thus, focusing on     overweight/obesity in youth with SED is critical to prevent their premature CVD. In 2015 the     American Heart Association called attention to mental illnesses in youth as important risk     conditions for early CVD and declared the need for transformational change in screening and     management of overweight and obesity. Despite this, studies of healthy weight interventions     in youth with SED are noticeably absent, and interventions will likely need to be tailored     for this population who frequently have impulsivity, oppositional behavior and/or mood     symptoms. In the general population, successful interventions targeting youth obesity often     include active parental participation. Community mental health programs serving youth     typically engage parents as part of routine treatment and therefore provide an unappreciated     but potentially important opportunity to address overweight and obesity. The objective of     this study is to design and rigorously test an innovative, scalable healthy weight     intervention in youth with SED that incorporates parental engagement and provider support.     The CHAMPION Trial is a two-arm trial partnering with community mental health organizations     in Maryland. We will perform population-based screening to identify youth with overweight and     obesity, and recruit and enroll 120 ages 8-18 years with SED with a BMI at or above the     85th%tile. The study will stratify by sex and site and randomly assign participants to     receive a) usual care plus educational materials on healthy weight, or b) the 12-month     CHAMPION intervention with 1) a health coach, a trained mental health program employee, who     provides healthy lifestyle counseling and support for weight management, a healthy diet and     increased physical activity incorporating techniques to engage both the youth and parents;     and 2) support from health providers who will provide basic weight management messages and     encouragement for behavior change. The intervention's first 6 months will include frequent     contacts, followed by a 6-month maintenance phase. The primary outcome will be decreased BMI     z-score compared to control at 12 months; secondary outcomes include waist circumference,     blood pressure, glucose, lipid levels, quality of life, and psychiatric symptoms at 6 and 12     mo. Antecedents of CVD begin early in youth, and those with SED are at particularly high     risk. Breaking this cascade of risk factors leading to premature CVD will require     capitalizing on the window of opportunity to intervene on overweight and obesity in youth     with SED. The CHAMPION Trial will test an innovative, yet practical approach that could be     readily incorporated into overall care of youth with SED.   "
16058|NCT03075293|"     The aim of this retrospective study is to determine the percentage of children with     appendicitis who were given analgesics or opioids in the ER, to reduce their pain.   "
16059|NCT03075280|"     To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in     improving patients' early recovery.   "
16060|NCT03075267|"     A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of     PT003 in healthy Chinese adult subjects   "
16061|NCT03075254|"     Chronic pain and fatigue are characterized by peripheral and central mechanisms including low     pain thresholds, temporal summation, peripheral and central sensitization. This application     will focus on central factors of chronic pain and fatigue. Functional brain imaging will be     used to characterized brain and spinal cord abnormalities that contribute to the mechanisms     of these disorders.   "
16062|NCT03075241|"     The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the     treatment of sleep disorders in Alzheimer's disease (AD)   "
16063|NCT03075228|"     Rationale: The microbial composition in the small intestine (SI) differs largely from the     composition in feces. Many physiological processes related to health, such as     immunoregulation and metabolic programming, mainly take place in the SI. Therefore, the SI,     from a microbiota perspective, is as relevant as the large intestine. There are indications     that microbiota composition is different in lean and obese subjects, and is related to     insulin resistance. However, these indications are mainly based on the analysis of fecal     samples. Therefore, analysis of the microbiota composition in the more proximal part of the     gastrointestinal (GI) tract may provide new insights into the microbial species that are     involved or related to metabolic homeostasis at that location. The IntelliCap® CR system     offers a minimally invasive tool that is able to collect reliable samples in the SI, as was     shown by NIZO in a clinical validation study. The main aim of the current study is to explore     and compare the upper GI microbiota composition in lean and obese subjects, in order to     generate new leads for development of products that may target the upper GI microbiota     community or specific species thereof, which may impact the maintenance of metabolic     homeostasis. This may provide new opportunities for the treatment, reduction or prevention of     overweight and/or obesity or insulin resistance.   "
16064|NCT03075215|"     To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population,     which optimization techniques are used and how effective they are. It will compare 12-month     response rates among different optimization methods and characterize which selected subject     subgroups achieve better response than others.      A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up     (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage     in a real world setting and monitor long term safety associated with these devices to support     CE Mark.   "
16065|NCT03075202|"     It is well established in the scientific literature that people with schizophrenia smoke     tobacco cigarettes at rates up to three times that of the general population, relapse more     frequently, and die an average of 25 years earlier from cigarette smoking and other     life-style attributable illnesses. Electronic cigarettes (e-cigarettes) are becoming     increasingly popular with smokers worldwide and new research suggests that e-cigarettes are     appealing to smokers with schizophrenia. There is a paucity of research focused on the     experience of smokers with schizophrenia who decide to try an e-cigarette. A well-designed     prospective-observational study is needed to learn more about the influence of e-cigarette     use on cigarette smoking behavior and mental and physical health among smokers with     schizophrenia. In response, the investigators have designed a study titled, Role of an     electronic cigarette on smoking displacement in smokers with schizophrenia: A prospective     3-month pilot study (SchizEcig).   "
16092|NCT03074851|"     Mass media plays more and more important role in health education, especially in some chronic     diseases which related closely with the behavior and habits. Past experience tells us that     with the help of related health education in mass media such as newspaper articles,     advertisements and videos on television, peoples can change their behaviors and habits in a     short period of time. But when these educational information were stopped, peoples usually     return to their original habits. Besides the national policy of the country how to improve     the long-term health education in the mass media should be considered.This study hopes to     seek an effective method to keep the mass media long-term focus on health education.   "
16066|NCT03075189|"     Up to approximately 38 (unknown drop-out rate) geriatric patients (at least 65 years old) are     recruited from a Geriatric ward at Slagelse Sygehus. After inclusion and baseline     measurements, each individual will be randomized into either an intervention or control group     arranged in blocks of 8 The intervention group (n≤19) will receive protein enriched     snacks/dishes in the morning and late evening, before bedtime. Moreover, upon discharge the     intervention group will receive individual dietary counseling focusing on choosing     protein-rich foods and on protein rich meals. The control group (n≤19) will receive normal     hospital food without enrichment and no dietary counseling at discharge. In both groups the     following data will be obtained: recorded protein intake, anthropometric measurements     (weight, height, body composition estimated with bioimpedance), functional ability (De Morton     Mobility Index (DEMMI) and Barthels ADL-index), hand grip strength, sarkopenic status     (SARC-F), quality of life (EQ-5D-3L), length of stay (LOS) and readmissions (within 30 days     after discharge). During hospitalization food intake will be registered, as well as 24 hour     recall interviews and food frequency questionnaires will be done at follow-up visits.      Assessments will be performed at baseline, on the day of discharge and 4 weeks after     discharge (follow up).      The primary outcome is change in protein intake from Baseline to 4 weeks after discharge.      The hypothesis is that serving of individually selected protein enriched snack/dish in the     morning and before bedtime during hospitalization results in higher protein intake during     hospitalization and that this experience combined with dietary counseling at discharge,     results in a higher protein intake at 28 days after discharge. Further, we hypothesize that     the increased protein intake will affect functional level, hand grip strength, sarcopenic     status and quality of life in geriatric patients and will lead to shorter LOS and fewer     readmission frequency.   "
16067|NCT03075176|"     This study evaluates the difference in results between eyes that have been treated wavefront     optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to     eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive     Keratectomy). Each participant will receive wavefront optimized correction in one eye and     topography-guided correction in the other.   "
16068|NCT03075163|"     This is a single site, prospective, randomized controlled study designed to evaluate the     impact of acupressure when used as an initial treatment before rescue medications in the     treatment of post-operative nausea and/or vomiting at UCD.   "
16069|NCT03075150|"     This is a prospective, randomized, sequential data collection study to evaluate the ability     of pleth variability index (PVI) to predict fluid responsiveness in comparison with other     dynamic parameters including pulse pressure variation (PPV) and stroke volume variation     (SVV).   "
16070|NCT03075137|"     Stroke is a prevalent atherosclerosis vascular disease with high mortality, external counter     pulsation (ECP) is an approved noninvasive therapy for angina, congestive heart failure,     myocardial infarction, and cardiogenic shock that augments blood flow to cardiac and systemic     circuits, which improves the flow volume in the carotid. Though ECP is Ⅱa recommendation for     stroke management, no multi-center control clinical study has been reported for prognosis of     stroke. The aim of this study is to evaluate the effect of ECP on stoke. To address this     assumption, investigators enroll subjects with ischemic stroke and randomized into control or     ECP group, the ECP intervention will be carried out with a standard protocol which involves     35 one-hour sessions (5 days a week) for continuous 7 weeks. The primary endpoint is mRS     score in 3 months, secondary endpoints include NIHSS, BI and MMSE score, recurrence of stroke     in 3 months, glycolipid metabolism, transcranial doppler (TCD) flow velocities and     endothelial function.   "
16071|NCT03075124|"     Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of     citizens, external counter pulsation (ECP) has been elucidated that it may release angina     symptoms and improve the prognosis of CAD, however, no multi-center control clinical study     has been reported for further recommendation. The aim of this study is to evaluate the effect     of ECP on CAD. To address this assumption, investigators enroll participants with stable CAD     and randomize them into control or ECP group, the ECP intervention will be carried out with a     standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks,     and the follow-up will last for 1 year. The primary endpoint is the 1-year composite     cardiovascular events (CCE), secondary endpoints include frequency of angina pectoris, heart     function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function.   "
16072|NCT03075111|"     This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay     (ImmunoXpert™).      The study will involve reviewing the medical charts of 4500 pediatric patients that were     tested using ImmunoXpert™ as part of the routine workup for acute febrile illness.      ImmunoXpert™ uses a computer algorithm to combine immunoassay measurements of three host     immune proteins (TRAIL, IP-10, and CRP) present in human blood. The test is intended for use     in conjunction with clinical assessments and other laboratory findings as an aid to     differentiate bacterial from viral infection.      Statistical analysis will be performed to compare the diagnostic accuracy of ImmunoXpert™     with that of current practice lab testing e.g., WBC, CRP, and PCT (whichever were taken as     part of routine care) and clinical suspicion at time of requisition.   "
16073|NCT03075098|"     The aim of this work is to detect the diagnostic accuracy of the intra-oral application of     colposcope in diagnosing oral dysplastic lesions in comparison to biopsy taking and     histopathological examination.   "
16074|NCT03075085|"     Investigators will pilot test the impact of an enhanced implementation strategy on     implementation and child health outcomes using continuous formative evaluation. Investigators     will test the hypothesis that better fidelity to the implementation strategy (WISE) is     positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).   "
16075|NCT03075072|"     This research study is studying two different types of radiation as treatment for brain     metastases (tumors in the brain that spread from a cancer that originated elsewhere in the     body)   "
16076|NCT03075059|"     1. Determine preoperative and postoperative levels of anxiety for pediatric patients ages          6-17 related to outpatient surgical intervention using the validated Psychosocial Risk          Assessment in Pediatrics (PRAP) assessment tool, the State-Trait Anxiety Inventory for          Adults(STAI-AD), and the State-Trait Anxiety Inventory for Children (STAI-CH)        2. Determine preoperative and postoperative levels of anxiety for parent/guardian of          pediatric patients ages 6 - 17 related to outpatient surgical intervention using the          validate PsychosocialRisk Assessment in Pediatrics (PRAP) assessment tool and the          State-Trait Anxiety Inventory for Adults (STAI-AD).        3. Assess if additional Child Life intervention offered pre-operatively to one group          demonstrates differences in PRAP scores compared to control group   "
16153|NCT03074058|"     The primary objective of this study was to establish the bioequivalence of two different     tablet formulations containing BAY77-1931. The secondary objectives of this study were to     assess the safety and tolerability, as well as to Investigate the plasma lanthanum     concentration after BAY 77-1931 ODT 500 mg administration.   "
16077|NCT03075046|"     Vulvovaginal candidiasis (CVV) is an infectious process of the female genitourinary tract, an     important health issue due to the high incidence and difficulties encountered in the     treatment. Therefore, new therapeutic modalities are sought with the capacity to minimize     drug side-effects and to reduce recurrent cases. The objective of this stufy is to evaluate     the clinical and microbiological response of the 405 nm blue light emitting diode in the     treatment of women with vulvovaginal candidiasis and in women with healthy gentourine     treatment. A clinical trial was conducted involving 40 women, divided into two groups, the     first group consisting of women with a confirmed CVV diagnosis and a second group formed by     women with a healthy genitourinary tract, without symptoms and symptoms of the disease. Both     groups underwent clinical evaluation and examination with endocervice collection with     gynecologist before and after a session of application of the Blue Light Emitting Diode of     405 nm, lasting 4.5 minutes. There will also be an evaluation of the effects of the diary     through the questionnaire answered before and after the participants' treatment. It is     expected that the 405 nm blue LED will destroy the CVV fungus demonstrated by laboratory     examination and also improve the signs and results analyzed by the gynecologist and     participants.   "
16078|NCT03075033|"     Background: Conventional intubation of the trachea and consequent prone positioning of     anaesthetized patients with cervical spine instability may result in secondary neurological     injury. Historically, the flexible fiber-optics used to be the chief choice for patients     presenting with cervical spine instability surgery either with normal, predicted difficult     airway, or even unanticipated difficult airway. Recently, the rigid optical stylets have     shown promise in assisting difficult intubations.      Purpose: The aim of the present study was to compare the efficacy of Shikani optical stylet     (SOS) with the flexible fiberscope for awake intubation in patients with cervical spine     instability.      Methods: Sixty adult patients with a neurosurgical diagnosis of cervical instability or at     risk of secondary cervical injury, who were planned for awake intubation and self-positioning     prone, were registered in this study and were randomly categorized into two equal groups     (thirty patients each), a fiberoptic group and a SOS group, then assessment of coughing and     gagging during and after intubation, time to intubation, number of attempts for successful     intubation, haemodynamic parameters, careful examination of the oropharynx to determine any     lip or mucosal trauma, and eventually the motor function by the ability to move arms and legs     were assessed after tracheal intubation and after positioning prone.   "
16079|NCT03075020|"     To investigate headache score and accompanying symptoms during and after inhalation of carbon     monoxide.   "
16080|NCT03075007|"     This study examines the factors that may drive the relationship between vascular disease and     Alzheimer's Disease (AD) in a large, longitudinal, multi-ethnic community-based cohort study     of older adults in northern Manhattan, New York. In past research, the investigators     demonstrated that accumulation of brain vascular disease is associated with risk for     development of AD. The study now extends the research to examine how brain vascular disease     and AD interact. In this pilot study, the investigators will obtain positron emission     tomography (PET) scans to measure amyloid (one of the protein pathological markers of AD)     from participants in an ongoing community-based study of aging and dementia (WHICAP). The     study will include subjects who are already enrolled in the parent project and already     evaluated at baseline with PET scans. The study plans to obtain 20 amyloid PET scans after a     5-year interval on the cohort of participants established at baseline. The investigators will     also conduct transcranial Doppler studies to measure blood flow in the participants with     amyloid PET scans. The potential benefits to society should be considerable if this study     reveals new information about risk factors for or contributions to AD.   "
16081|NCT03074994|"     Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and     unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA)     have been well established in reducing blood loss postoperatively. However, there are lack of     data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a     three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding     reduction of peri-articular TXA injections, intraarticular TXA injections and control group.   "
16082|NCT03074981|"     Difficult to heal wounds are a common and complex medical problem, causing suffer to the     patients and challenging medical, social and economic burden on the health system. Based on     data from the western world, it is estimated that in Israel, at any given time, 30 to 60     thousand patients with difficult to heal wounds. Among diabetics patients, it is estimated     that 15% to 25% will develop a difficult to heal foot wounds during their live time.      The medical definition of a difficult to heal wounds is: a wound showing no signs of recovery     after 4-6 weeks of treatment. Most of these wounds are caused by anaerobic bacteria     inventions.      One of the methods for the treatment of difficult to heal wounds is - ROI-RNPT (Regulated     Oxygen -Enriched & Irrigation Negative Pressure -Assisted Wound Therapy).      This method creates in the wound a negative pressure in the presence of oxygen and irrigation     applied directly into the wound bed.      As part of the wound closure process the investigators will use the external tissue     expansion. This method under clinical use is exercised by the - Top Closure tension     relief system (TRS).      In this study, the investigators intend to investigate whether ROI-NPT system combined with     TopClosure, is effective for the treatment of difficult to heal wounds, compared with methods     currently in use.   "
16083|NCT03074968|"     This study is designed to examine the effect of benzydamine hydrochloride to postoperative     sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline     at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative     sore throat using smartphone application in pediatric patients.   "
16093|NCT03074838|"     A controlled un-randomized trial where the inflammatory response in 18 patients admitted for     TAVI procedure is compared to the inflammatory response in 18 patients admitted for     conventional surgical valve replacement. Clinical outcomes are recorded and compared between     the Groups. As a secondary endpoint, the inflammatory response was also compared between the     patients receiving either transfemoral or trans aortal TAVI.   "
16154|NCT03074045|"     To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age     [inclusive]), using LCS16 compared to a COC over a period of 12 months.   "
16084|NCT03074955|"     Although propofol is widely used as an induction agent for a general anesthesia, it can     induce a profound hypotension, which leads to the hypo-perfusion of end organs and eventually     increases morbidities. Theoretically, applying Trendelenburg position (head down and leg up     position) increases cardiac preloads and cardiac outputs. However, in past researches,     changing to Trendelenburg position alone is not enough and does not prevent propofol induced     hypotension. Previous studies proved that leg wrapping effectively prevent hypotension after     neuraxial anesthesia during Cesarean section. The leg wrapping prevents hypotension by     increasing vascular resistance of lower extremities. The investigators made a hypothesis that     applying both Trendelenburg position and leg wrapping prevent propofol induced hypotension     more effectively than either applying Trendelenburg position only or taking no preventive     measures.   "
16085|NCT03074942|"     Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of     the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting     β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control     concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab     has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of     life in severe allergic asthmatics. However, approximately 25% of the treated patients fail     to respond to this monoclonal antibody. The rest of them show different degrees of response,     although the rate of asthmatics who achieve control of the disease is unknown because     clinical trials of omalizumab have been carried out to assess the impact of the drug on     exacerbations, symptoms or even pulmonary function, but its effect on control was not     evaluated. Therefore, there is a need to find new therapeutic options for those severe     asthmatics who remain uncontrolled despite having received all the recommended therapies     (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal     antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary     function and symptoms in patients with severe asthma and high peripheral eosinophil counts.     It would be important to demonstrate that Reslizumab is able to improve the clinical     condition of severe asthma patients with no therapeutic options.   "
16086|NCT03074929|"     One-third of American children are overweight or obese, leading to an increased risk for     cardiovascular disease (CVD), early mortality, and other risks throughout their lifespan     relative to normal weight children. In our pilot work, we found that 67-83% of parents     underestimate a child's long-term risk of developing cardiovascular disease in adulthood and     that parents thought their own child's risks were 13-15% lower than those of a typical child     in their community, even controlling for family health and demographic characteristics.     Parents were 40 times less likely to predict that their child, rather than a typical child in     their community, would be overweight or obese in adulthood. These findings suggest that     parents suffer from optimism bias, the tendency to overestimate one's chances of experiencing     unlikely positive events. Belief that a child is at increased risk for adverse health     outcomes in adulthood could be an important motivator for a family to initiate behavior     changes and vice versa.      The overall goal of this research is to develop provider-based risk communication approaches     to motivate parents of obese children to engage in behavior change to protect their children     from CVD and other obesity-related co-morbidities later in life. Specifically, the     investigators will:        1. Develop risk communication methods that providers can use to better convey accurate          information about a child's health behaviors, obesity status, and future health risks to          parents.        2. Using an online experiment, we will evaluate the impact of new risk communication          methods on parental engagement in behavior change.        3. Pilot test the feasibility, acceptability, and impact of new risk communication          approaches in pediatric primary care clinics.      This work will give pediatricians novel tools to effectively discuss the long-term     consequences of childhood obesity with parents. The findings from this work will inform an     interventional trial that will assess the impact of improved risk communication techniques on     child behavior change and health outcomes.   "
16087|NCT03074916|"     The objective of this project is to investigate the subjective and clinical outcome in     patients at least one year after DIP arthroplasty and compare them to matched patients with     an arthrodesis.      The primary endpoint is the satisfaction with the treatment result of in the     motion-preserving DIP surgery at follow-up.   "
16088|NCT03074903|"     Women presenting for contraception will be offered the IUS Skyla and study participation.     Daily bleeding will be collected for a total of 90 days and correlated with insertion timing     and baseline endometrial thickness.   "
16089|NCT03074890|"     Massive haemorrhage is defined as the necessity of 3 or more packed red blood cells in one     hour, the transfusion of 10 packed blood cells, the loss of the half of the blood volume, the     loss of 4-5 cc/kg/h or more, and haemorrhage shock.      Haemorrhage shock provokes changes in the bloodstream with celular and organic disfunction.     In many cases massive transfusion is needed to stabilize the vital function. This massive     transfusion can have serious side effects (infectious and immunologic and no immunologic     reactions) and increase the morbidity and mortality.      Massive transfusion protocols improve the survival in severe trauma injury patients. The     transfusion of fixed rate of packed red blood cells, fresh frozen plasma and platelet     concentrates have decreased the severity of trauma induced coagulopathy.      Recently several studies have shown the benefit of massive transfusion protocols with high     transfusion ratios (1:1:1 RBC:FFP:PLT) in mortality after severe trauma. So early and     aggressive transfusion improve the outcomes and the resources.      Massive Transfusion Protocol have been elaborated in the Hospital Universitario de Canarias     with high transfusion ratios (1:1:1 RBC:FFP:PLT) . The goals of this protocol is to reduce     the variability in the clinic experience, to reduce the transfusion necessities and to assure     an safe treatment with blood products.      So with this study the investigators will evaluate if the goals of this Protocol are followed     and if the use of this Protocol is really safe and efficient.   "
16090|NCT03074877|"     This study is to test the effectiveness of integrating and adapting two National Institute on     Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving     low-income youth: 1)the Youth Risk Index (YRI) and Transmissible Liability Index-Parent     (TLI-P) nurse and/or research assistant-administered screening tools for high risk of     substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up     (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.   "
16091|NCT03074864|"     The aim of this study is to investigate the efficacy and safety of intercalated combination     of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced     NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib,     local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.   "
16094|NCT03074825|"     Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora     B）、VEGFR/PDGFR/c-Kit、CSF-1R targets.      This clinical trial is studying the efficacy and safety of chiauranib works in treating     patients with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the     latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical     benefit.   "
16097|NCT03074786|"     Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR)     containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF     oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study     product use periods, participants will then select between the two study products to use in     the final 24 weeks of the trial. Participants will be able to choose either or neither study     product every 4 weeks during the third product use period.   "
16098|NCT03074773|"     Anesthetic management for surgery of aortic coarctation needs special care due to severe pain     during lateral thoracotomy incision, the intraoperative hemodynamic instability related to     skin incision at lateral thoracotomy, clamping and declamping of the aorta, needs of large     doses of analgesia perioperative, needs of vasodilators. Also, postoperative care of the     patients after repair is very important issue. The investigators will compare the effect of     para-vertebral block with bupivacaine alone or with dexamethasone on Intra and postoperative     analgesia.   "
16099|NCT03074760|"     A major water supply utilized in the Lambayeque region are acequias. Acequias are irrigation     canals that are utilized by the agriculture industry for the cultivation of consumables.     Utilization of contaminated water to irrigate consumables can lead to foodborne illnesses.     Contamination studies on the acequias in the Lambayeque region have not been performed to     date. The purpose of this study is to test contamination of acequias in 9 districts in     Lambayeque and determine if a difference in infection rates exists in districts with     contaminated acequias vs. districts without contaminated acequias for the following diseases:     H. pylori, Adenovirus, Rotavirus.   "
16100|NCT03074747|"     Background: Obstructive sleep apnea (OSA) refers to the apnea and hypopnea caused by upper     airway obstruction during sleep. Patients are associated with sleep disorders, frequent     desaturation, hypertension, coronary heart disease, cerebrovascular disease and diabetes. OSA     prevalence increased in China in recent years. It is estimated that nearly 80% of men and 93%     of women are not diagnosed for moderate and severe OSA. Anesthesiologists and surgeons paid     more attention on those high risk patients. The gold standard for OSA diagnosis is apnea and     hypopnea index (AHI) obtained from polysomnography (PSG). But it is difficult to carry out     PSG regularly in primary health care institutions in China for its high cost and long waiting     list. So many OSA questionnaires are developed in Europe and North America, obesity is an     important risk factor for OSA for them. But in China people have different anatomical     characteristics, the diagnosis sensitivity and specificity of those methods has not been     reported in China.      Methods and Design: Participants for this study will be recruited in Beijing Tongren Hospital     scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients     will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in sleep     center. 2. To receive OSA correction surgery (UPPP). 3. To receive ophthalmological surgery     under general anesthesia.      Detailed inquiry and record all medical history. Upper airway assessment will be recorded.     Preoperative snoring questionnaires will be integrated according to the four questionnaires.     All patients complete PSG monitor. For patients undergoing surgical treatment, postoperative     continuous pulse oximetry will be recorded for 24 hours. All postoperative adverse events     will be recorded.      The primary endpoint:      All the patients complete the four snoring questionnaires (ASA, Berlin, STOP and STOP-BANG)     before PSG test.      The secondary endpoints:      PSG monitor will be completed before operation. Medical history, upper airway assessment,     postoperative 24 hours continuous pulse oximetry monitor and all perioperative adverse events     will be recorded.      The purpose is to compare the specificity and sensitivity of four questionnaires to figure     out OSA. To find suspected OSA patients before operation with one easy-to-use assessment     questionnaire and direct OSA clinical practice.   "
16101|NCT03074734|"     Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a     clinical research study, aiming at: i) to measure respiratory health effects when exposed to     secondhand smoke (SHS) in patients with asthma and Chronic Obstructive Pulmonary Disease     (COPD); ii) to investigate exposure levels to SHS in smoking areas provided by bars, casinos,     bingo halls, etc. The study will involve 60 patients (volunteers) in three European     countries: Hungary, Ireland, and Spain, recruiting 20 patients in each participating country     (10 COPD and 10 asthma patients).   "
16102|NCT03074721|"     The PCI Suite is developed by Philips Medical Systems, a Philips Healthcare company. The     proposed PCI Suite is a new software package which can be used during coronary interventions.     The software package includes two sub-packages, known as StentBoost and Cardiac Roadmapping.      The patient will undergo standard of care medical treatment for his or her cardiac condition.     During the procedure, the physician may make angiograms for diagnosis and as reference for     device navigation as part of the standard care. These angiograms will be automatically     processed in PCI Suite and displayed on fluoroscopy for navigation support. In case a balloon     catheter is inserted into the coronary arteries, the physician may take cine images as part     of the standard care. These images can be automatically enhanced in PCI Suite. The primary     objective of this prospective, mono-center, randomized clinical trial is to evaluate the     amount of contrast medium used during percutaneous coronary intervention.   "
16103|NCT03074708|"     Background:The aim of the study is to value the application of three-dimensional     visualization and three-dimensional printing in the hepatobiliary and pancreatic     surgery.Method：From January 2016 to December 2018,the clinical data of 200 patients with the     hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal     CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D     printed model based on the 3D reconstruction model in the operation planning and the     operation.The clinical data include operative time, intraoperative blood loss,and     postoperative complications after surgery.   "
16104|NCT03074695|"     The primary purpose of this study is to determine differences in block quality between the     dural-puncture epidural (DPE) and standard epidural (EPL) techniques for labor analgesia in     the morbidly obese patient. The investigators hypothesize that when compared to the standard     EPL, the DPE technique will improve block quality .      Study participants will be randomized by computer-generated sequence to EPL or DPE arms,     stratified by class of obesity (BMI < 50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous     versus multiparous). All patients will receive a neuraxial technique in the sitting position     at L3/4 or L4/5 using loss of resistance to saline. In the DPE group, a 25-g Whitacre needle     will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5     cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl     (2 mcg/ml) over 6 minutes as per standard practice. After the initial loading dose and     epidural pump is started, the blinded investigator will enter the patient's room to start     data collection (time 0). Data will be collected for the first 30 minutes of epidural     placement at 3,6,9,12,15,18 21, and 30 minutes to detect the time to achieve target pain ≤     1/10, then assessed at standardized times (ever 2 hour) until delivery. Breakthrough pain     will be managed by a standardized protocol. Other data to be collected will include: catheter     adjustments and replacements, physician top-ups, asymmetrical block, pain score, motor block,     sensory level to ice, hypotension, total anesthetic dose required, and PCEA use.      The primary outcome of this study is block quality defined by a composite of five components:     (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter     adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring     general anesthesia or replacement neuraxial anesthesia for emergency cesarean section.     Secondary outcomes include time to numeric pain rating scale ≤1, maternal adverse events     (hypotension, fetal bradycardia, PDPH), motor block, duration of second stage of labor, total     labor epidural time, total anesthetic dose required, PCEA use, and mode of delivery.      There is no increased risk/safety issue with placing a dural puncture technique than with     epidural for labor analgesia.   "
16107|NCT03074656|"     Infliximab and other TNF-inhibitors have revolutionised the treatment of several     immunological inflammatory diseases. Still, more than half of the patients either do not     respond sufficiently to infliximab therapy or loose efficacy over time. The large individual     variation in the serum drug concentrations on standard doses and the development of anti-drug     antibodies are thought to be main reasons for these treatment failures. An individualised     treatment strategy based on systematic assessments of serum drug concentrations, therapeutic     drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab     treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an     economical point of view, but the effectiveness of this treatment strategy still remain to be     shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial     in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to     achieve remission in patients with immunological inflammatory diseases starting infliximab     treatment (part A) and in order to maintain disease control in patients on maintenance     infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to     an implementation of a personalised medicine approach to treatment with infliximab and other     biological drugs.   "
16108|NCT03074643|"     This study will evaluate the effects of diet composition (i.e., amount of protein and     carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on     physical function, muscle mass, and weight loss maintenance in obese older adults.     Participants will receive either a protein or carbohydrate supplement along with a behavioral     weight loss intervention.   "
16109|NCT03074630|"     Objective: To investigate the effect of 5 weeks dapagliflozin 10 mg once daily treatment on     glucose and lipid fluxes in patients with type 2 diabetes.      Study design: Single center single arm (mechanistic) intervention trial.      Study Population: Male or postmenopausal female patients with type 2 diabetes BMI > 25     kg/m2and more than 12 weeks a stable dose of metformin treatment > 1500mg, HbA1C ≥6.5% -     <8.5%, Fasting Plasma Glucose (FPG) <13.2 mmol/l, LDL cholesterol >2.5 mmol/l, willing to     switch to rosuvastatin 10mg once daily for 4 weeks, and then receive 10 mg dapagliflozin once     daily orally, for 5 weeks.      Treatment: After a statin washout fase of 4 weeks, baseline cholesterol synthesis will be     measured (2H3 Leucine, 2H2O deuterated water). Then, treatment with rosuvastatin 10mg for 4     weeks will be initiated after which, patients will undergo glucose (2H2enriched glucose) and     lipid flux (2H3 Leucine, 2H2O deuterated water and oral 1,2,3,4-13C16 - palmitate enrichment     measurements) followed by 5 weeks treatment with dapagliflozin 10mg once daily. In the final     week glucose/lipid flux measurements will be repeated.      Sample Size: 12 DM2 subjects.      Outcome measures: The primary endpoint is effect of 5 weeks Sodium-Glucose Linked     co-transporter (SGLT) 2 inhibition on LDL cholesterol synthesis in patients with DM2.     Secondary endpoints are effect of SGLT2 inhibition on triglyceride and cholesterol fluxes as     well as (hepatic and peripheral) insulin sensitivity and energy expenditure. Finally, effect     of SGLT2 inhibition on dietary intake, liver fat content (MRI liver) and fecal microbiome     will be studied at these timepoints.   "
16110|NCT03074617|"     The effect of electromagnetic fields of the latest standard in mobile communication (long     term evolution, LTE) on sleep is studied in healthy, young individuals.   "
16111|NCT03074604|"     The objective of this study is to investigate the value of employing the aortic no-touch     off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field     flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary     revascularization.   "
16112|NCT03074591|"     This study addresses, whether treatment with IV iron for patients with heart failure with     preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia,     can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while     being safe   "
16113|NCT03074578|"     There is a need for quantify the emotional and neurophysiological perception of verbal     violence, in order to understand the impact it might have on a subject. This project aims at     assessing the influence of time, sleep, and people interaction on the perception of verbal     violence.   "
16114|NCT03074565|"     Periodontitis is a chronic oral infection that results in the breakdown of connective tissue     and alveolar bone that support the teeth. Non-surgical sanative therapy using a combination     treatment of hand and ultrasonic instrumentation is the primary treatment option for patients     with periodontitis. However, the hand-held instrumentation requires continuous sharpening for     optimal outcomes, which introduces tremendous variability as well as a large increase in time     spent by the treating dental hygienists. Therefore, this study aimed to determine if     ultrasonic instrumentation alone can provide similar improvements to periodontal outcomes     compared to ultrasonic plus hand instrumentation.   "
16115|NCT03074552|"     Ventilator-associated pneumonia (VAP), is a type of pneumonia that develops more than 48     hours after endotracheal intubation, is common in intensive care units (ICUs). It is     estimated to be responsible for 27% to 47% of ICU-acquired infections.      The pathogenesis of VAP is complex but typically involves colonization of the aerodigestive     tract with pathogenic bacteria, the formation of biofilms, and microaspiration of     contaminated secretions. Preventing carriage of potentially pathogenic micro-organisms from     the aerodigestive tract is an infection control strategy used to reduce the occurrence of     VAP. One novel intervention is the administration of prophylactic probiotics which restore     non-pathogenic flora that compete with pathogens, modulate local and systemic immunity, and     decrease intestinal permeability and thus can be beneficial in preventing nosocomial     infections in critically ill patients. The role of the probiotics in preventing VAP in     mechanically ventilated patients is inconclusive. Some evidence indicates that probiotics may     reduce the incidence of VAP by inhibiting pathogen adhesion, improving gut mucosal barrier     function, reducing bacterial translocation and up-regulating the immune system. Furthermore,     guidelines remain inconclusive regarding the role of commensal oropharyngeal flora (COF) as a     causative agent in VAP, mainly due to a scarcity of studies in this research field. However,     there is evidence that COF may cause pulmonary infection, mostly in immunocompromised     patients.   "
16155|NCT03074032|"     This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be     escalated to the next doses with the safety, tolerability, and PK being evaluated in     metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA     values will be evaluated during the study as an additional point.   "
16116|NCT03074539|"     There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with     Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes     Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no     information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the     use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious     disease and there may be a bidirectional association of SDB and CTEPH.      This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of     large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will     be analyzed and CTEPH patients for possible PAP treatment will be defined.   "
16117|NCT03074526|"     To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection,     placebo control in the treatment of moderate osteoarthritis of the knee.   "
16118|NCT03074513|"     The goal of this clinical research study is to learn if atezolizumab and bevacizumab can help     to control rare solid tumors.   "
16119|NCT03074500|"     The aim of this study is to compare the effects of kinesiology taping with exercise, sham     taping with exercise and exercise alone for lateral epicondylitis.   "
16120|NCT03074487|"     During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to     the myelum can result in hypoxia, compromising proper function of the spinal cord.      Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional     integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord     ischemia. Moreover, these potentials react within minutes, which facilitates interventions to     restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the     rate of paraparesis to < 5%. Unfortunately, in the early postoperative period, spinal cord     vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical     procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead     to critical loss of function. This inadequate perfusion results in delayed paraparesis. In     the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due     to the high intensity of the electrical stimulus, which is unacceptably painful in the     unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which     can detect spinal cord ischemia postoperatively early, thus preceding the phase with     clinically overt paraparesis. The test should be reliable and easy to perform for an extended     period of time (up to several days).      The purpose of this study is to explore the usefulness of various neurophysiological tests     regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular,     to find a diagnostic test which is acceptable for the unanesthetized or partially     anesthetized patient and therefore can also be performed postoperatively. These tests will be     examined in fully sedated as well as partially sedated patients.      The following candidate tests will be examined:        1. Long loop reflexes (LLR) consisting of F-waves.        2. Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy          (NIRS).   "
16121|NCT03074474|"     The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia     repair leads to the same or a lower percentage of early post-operative complications and true     hernia recurrences when compared to other types of available meshes. 100 subjects will be     included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair     surgery, a baseline visit will be performed during which the patient's eligibility for the     study will be evaluated. The surgical technique used for the repair will be determined by the     investigator/surgeon. Additional study data will be collected during the hospital stay, 30     and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits,     the surgical site will be evaluated by the surgeon, both the surgeon and patient will be     asked to rate their satisfaction with the repair and the subject will be asked to complete     two Quality of Life questionnaires.   "
16122|NCT03074461|"     CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end     anastomosis as rectal reservoir reconstruction offers the best functional results.   "
16123|NCT03074448|"     Poor or inadequate bowel preparation is one of the most common reasons for a repeated or     failed colonoscopy. Preparation methods shown to be effective include the use of either     bowel-cleansing devices or oral laxatives. Despite the acceptable effectiveness and safety of     both bowel-cleansing methods, very few studies have been performed to evaluate which method     is more effective. The main aim is to perform an observational study followed by propensity     score modeling to evaluate and compare the quality of bowel preparation with the use of     Aquanet bowel-cleansing devices versus the use of oral Sodium picosulfate solution. The study     will involve 314 patients requiring a colonoscopy, between 14 and 90 years of age and with     more than three bowel movements per week for the past one month. Outcomes of interest being     the quality of bowel preparation evaluated through the Boston Bowel Preparation (BBP) scale.     The investigator hypothesized that the bowel preparation with Aquanet bowel-cleansing device     for colonoscopy will provide a better outcome for the patient than with conventional methods.   "
16124|NCT03074435|"     This study evaluates the benefit to use 1) insecticidal paints, 2) larvicides, 3) Ivermectin     for both human and domestic animals and 4) strengthened Information, Education and     Communication (IEC) strategy to complement the universal coverage with LLINs through a     cluster randomized trial.   "
16125|NCT03074422|"     In certain neurosurgical procedures, the use of a stereotaxic frame is required. It is then     possible to set a precise target (depending of the type of the surgery) to be reached by the     surgeon. The fixation of the stereotactic frame on the awake patient's head is done under     local anesthesia by screwing the frame directly into the skull. This procedure is reported as     painful to extremely painful by patients. The objective of this study is to determine     whether the hypnosis is effective in decreasing the pain perceived by the patient during the     disposal of the stereotactic frame.   "
16126|NCT03074409|"     This study is designed to investigate oxytocin's effects on interoception and whether these     effects vary as a function of different emotional valence.   "
16127|NCT03074396|"     The investigators developed and used the DialysisNet mobile application for physicians and     Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration     and exchange were based on the American Society for Testing and Materials Continuity of Care     Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to     evaluate user experience and usefulness were administered before and after use.   "
16149|NCT03074110|"     Isocapnic hyperventilation (IHV) is a method that shortens time to extubation after     inhalation anaesthesia by increasing airway carbon dioxide (CO2) during hyperventilation     (HV). In two experimental studies (mechanical lung model and porcine model) and in a pilot     study on patients undergoing sevoflurane anaesthesia for major ear-nose-throat (ENT) surgery,     the investigators evaluated the feasibility of an alternative technique of IHV. By performing     a prospective, randomised controlled study, the investigators want to further test this     alternative method for IHV.   "
16128|NCT03074383|"     Ninety-six patients with diabetes will be randomly assigned to maintain standard treatment or     participate in the Self-Care Multidisciplinary Workshop for Diabetes. The workshop consists     of individual meetings, with a multidisciplinary team (nurse, pharmacist, nutritionist,     physical educator and social worker) in which education and self-care topics will be     approached aiming at the formation of knowledge and skills necessary for patient self-care.     The workshop will be offered in 3 different modules with 2 to 4 weeks difference between     them. The variation of glycated hemoglobin as well as aspects associated with self-care,     adherence and treatment satisfaction will be evaluated at the study entry, 6 and 12 months     later.   "
16129|NCT03074370|"     Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with     Bimaxillary-dentoalveolar Protrusion.      A Retrospective Cohort Study.   "
16130|NCT03074357|"     This biomarker study is a follow-up to CPLATFRM2201. The goal of CBASICHR0005 is to collect     another urine sample, interval clinical information, and an optional DNA sample from as many     of the original 80 patients as possible. This new information will transform the data     obtained in PLATFRM2201 from a cross-section to a temporal profile, which will (a) further     enable the identification of biomarkers predictive of faster progression, and (b) satisfy the     FDA's recommendation to perform natural history studies in rare diseases.   "
16131|NCT03074344|"     Background: Dry eye disease (DED) is a common condition causing burden on visual function and     reducing quality of life. Corticosteroids and/or cyclosporine eye drops are able to improve     DED symptoms, however, side effects of immune suppression and cost lead patients often to     suspend treatment. Consequently, is important to identify therapies alleviating DED symptoms.     A randomized, controlled, single masked study, was performed in 40 patients affected by mild     to moderate DED, to evaluate efficacy and safety of a collyrium based on cross-linked     hyaluronic acid (XLHA) added with Coenzyme Q10 (CoQ10) in comparison to an eye drop     considered a gold standard for tear substitutes, based on hyaluronic acid (HA) 0.15%.      Methods: eye drops were administered four times a day for 90 days to enrolled subjects     divided in two groups: group A treated with XLHA+CoQ10, group B treated with HA. Ocular     Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure (IOP), fundus     exam, tear break-up time (TBUT), corneal and conjunctival fluorescein staining, corneal     esthesiometry, corneal confocal microscopy, were performed at different visits until the 90th     day.   "
16132|NCT03074331|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) for 12     weeks in adults with chronic hepatitis C virus (HCV) infection.   "
16133|NCT03074318|"     This phase I/II studies the side effects of avelumab and trabectedin and how well they work     in treating patients with leiomyosarcoma or liposarcoma that has spread to other places in     the body or cannot be removed by surgery. Monoclonal antibodies, such as avelumab, may block     tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such     as trabectedin, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving     avelumab and trabectedin may work better in treating patients with liposarcoma or     leiomyosarcoma.   "
16134|NCT03074305|"     The aim of the study is to compare angiographic outcomes following revascularization using     drug-eluting balloon (DEB) versus 2nd generation drug-eluting stent (DES) in treatment of     Bioresorbable Vascular Scaffold Restenosis.   "
16135|NCT03074292|"     The aim of the present study is to test a hypothesis assuming that phototherapy might have an     effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated     hyperbilirubinemia.   "
16136|NCT03074279|"     Numerous studies over the past decade have shown without any doubt that there is a higher     mortality risk in patients with epilepsy than in the general population. The cause of death     may be related to the cause of epilepsy, being directly related to a seizure (status     epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures     (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic     heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is     defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not     necessarily in the presence of witnesses, that is not due to drowning, with or without     evidence of a seizure, excluding documented status epilepticus and in which a post-mortem     autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP     and its mechanisms and risk factors.      This epidemiological study is based on the RSME. The Main objective of this study to identify     risk factors of SUDEP, in particular night-time supervision and the risks associated with     anti-epileptic drugs including compliance and drug interactions.   "
16137|NCT03074266|"     This study is designed to evaluate and verify the clinical accuracy of the Hemochron® MCS     7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting     Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood     Microcoagulation System; a 510(k) cleared predicate device. This is a multi-center,     prospective method comparison, with data to be analyzed separately from each site as well as     combined for all sites.   "
16138|NCT03074253|"     Cardiovascular Imaging and Biomarker Analyses (CIBER) is a single-center, prospective and     observational study evaluating the expression of novel biomarkers in patients undergoing     cardiacvascular imaging within clinical routine care. It is aimed to evaluate associations     with biomarker expressions with ascertained cardiac imaging parameters.   "
16139|NCT03074240|"     Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block     (RSB) to provide surgical anesthesia for obese patients undergoing umbilical hernia surgery.   "
16140|NCT03074227|"     A Double-blind randomised placebo-controlled pilot study as well as a reversed translational     part To investigate whether two faecal transplantations from either allogeneic (healthy) or     autologous (own) donor, administered through a nasoduodenal tube, has beneficial effects on     irritable bowel syndrome (IBS) symptoms such as abdominal pain frequency and severity.     Secondary objective is to study microbiota changes in faeces samples.   "
16150|NCT03074097|"     Good quality of postoperative analgesia would lead to attenuate or prevent the adverse     effects on the common functions of the immune system. We compared the effect of epidural     analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines     following malignant urological surgery.   "
16141|NCT03074214|"     ST-elevation myocardial infarction (STEMI) has a serious health threaten to population. PCI,     which can timely restore the blood flow to the ischemic myocardium, is a well-proved measure     in STEMI management. However, the process of the restoration can induce injury. The     phenomenon is defined as ischemia/reperfusion (I/R) injury. The studies indicate that I/R     injury accounts for up to 50% of the final myocardial infarct size. However, previous     attempts to target known mediators of myocardial I/R injury in patients have been     disappointing, leading to calls for a reevaluation of factors affecting myocardial I/R injury     [1]. Arginine vasopressin (AVP), that response to acute illness, is unstable and cleared     rapidly from the circulation. However, copeptin, the C-terminal portion of provasopressin, is     released in equimolar amounts to AVP and is easy to determine. So, copeptin can be a     surrogate marker for AVP secretion. Recently, copeptin was found to serve as a potential     prognostic biomarker in heart failure and acute myocardial infarction (AMI). AMI can activate     the AVP axis, which have a causative role in the evolution of heart failure. Increasing     copeptin was shown to correlate with myocardial remodeling, mortality and morbidity. In     patients with STEMI, myocardial infarct size is a stronger outcome predictor than LV     function, and is related to LV remodeling, which often indicates a significant worse     prognosis after AMI. As the gold standard for characterisation of cardiac structure and     function, cardiac magnetic resonance (CMR) parameters can serve as surrogate end points in     clinical trials of STEMI. We hypothesised that plasma copeptin values, tested before and     after PCI, are related to myocardial infarct size, myocardial function both and outcomes at     baseline and 6 months follow-up as assessed by CMR in patients with STEMI.   "
16142|NCT03074201|"     Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free     ERCP for non-complex bile duct stone disease.   "
16143|NCT03074188|"     There are severe deficiency of database concerning the oral health status in both     pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study     is to assess the oral health of the chronic kidney disease patients to increase their     awareness and minimize all the possible risk factors, to achieve a proper management for all     oral problems.   "
16144|NCT03074175|"     Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the     main pathological type is non-small cell lung cancer (NSCLC). Most of them present with     advanced stage at diagnosis. Radiotherapy is an important treatment strategy for advanced     non-small cell lung cancer. However patients have different responses to radiotherapy due to     individual differences, thus there is still lacking of sensitive markers to predict treatment     response at present. Using bioinformatics to process the data and small sample clinical     trial, our previous study found 5 plasma miRNAs were related to radiosensitivity. The design     is controlled clinical trial. According to the size of lung lesions, the investigators     divided the patients into hyperfractionated radiotherapy group（50Gy/11F/2W) with lesion ≤5cm     in diameter and conventional fractionated radiotherapy group（60Gy/30F/6W）with lesion >5cm in     diameter.   "
16145|NCT03074162|"     The main objective of this study is to assess the relative systemic bioavailability of     diclofenac in the presence and absence of capsaicin by comparing the systemic bioavailability     of diclofenac from a combination product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) with     two diclofenac only products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel,     following topical administration.      In order to examine potential racial differences in pharmacokinetics (PK), the study     population will be stratified 50:50, Caucasian versus Black people. With respect to the main     objective, additionally a supportive analysis will be performed to investigate the influence     of race on the intra-individual bioavailability ratios.   "
16146|NCT03074149|"     To gain further insight on the characteristics, management, disease progression and the     outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice     conditions in Greece. More specifically, this registry will be used to: Provide a     comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF     patients over time, Examine the implementation of treatment guidelines used on patients     diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of     patients on different treatments. To provide information regarding survival and mortality     causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial     infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis,     hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF     patient hospitalization will be collected and evaluated with regards to potential respiratory     causes, and there will be documentation of treatment patterns and economic aspects. Patients     will be followed up for 2 years and information regarding IPF treatment changes since the     last visit will be collected.   "
16147|NCT03074136|"     The pulp necrosis of permanent immature teeth implies the interruption of the root formation     and apical closure. Diode lasers have been used in many areas of dentistry, with tendency of     good results in canal and dentine disinfection. The bactericidal effect of high-power lasers     is based on dose dependent heat generation. Its antimicrobial effectiveness against diverse     microorganisms has already been demonstrated. Photodynamic therapy (PDT) is a two-step     therapeutic approach starting with the application of a photosensitizing agent and followed     by irradiation with light energy that is spectrally matched to activate the drug. The balance     between disinfection and the creation of an intracanal microenvironment conducive for the     proliferation of stem cells requires further investigation. Aims of study are to compare the     time required to obtain the clinical healing and the disappearance of clinical symptoms, and     absence of periapical radiolucency, by using PDT and diode laser, with standard disinfection     alone; to assess specificity of microbial load in permanent immature teeth, and root canal     disinfection ability of PDT and diode laser, in compare with standard disinfection alone.   "
16148|NCT03074123|"     Previous study showed that afternoon cosyntropin testing was associated with a sevenfold     increased likelihood of failing the 1μg test. However, in that study, investigators used a     20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther     current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a     short 2.5 cm tube.   "
16151|NCT03074084|"     This is a non-randomized, prospective, population-based, single-center study designed to     evaluate conditions resulting emergency admission in patients with abdominal pain.     Furthermore, we are interested in how many patients are discharged with non-specific     abdominal pain but later readmitted and diagnosed with a specific diagnosis.   "
16158|NCT03073993|"     Enteral feeding tubes in newborns are used for feeding preterm and low birth weight babies in     neonatal intensive care units as they often do not suck effectively owing to lack of     coordination between sucking, swallowing and breathing due to neurological immaturity and     delayed gastric emptying.      The feeding tubes could be inserted by the nasogastric (NG) route or by the orogastric (OG)     route. Both routes are used in different Neonatal Intensive Care Units (NICUs). Both methods     are associated with different adverse events.      Since newborn infants are obligate nose breathers, nasogastric tube (NGT) can lead to partial     nasal obstruction which might increase airway resistance and work of breathing although they     are easy to secure to the face than orally placed tubes. Orogastric tubes (OGT), on the other     hand, may not lead to the potential risk of increased work of breathing associated with NGT     but are more frequently malpositioned and can loop inside the mouth. Also there is increased     possibility of apnea and bradycardia due to vagal stimulation.      Despite so many years of continuing debate, the evidence of superiority of one method over     another is not proven. Very few studies have tried to look into this matter and there are no     consensus guidelines. This study is being conducted to compare the rate and type of adverse     events in OG versus NG feeds in preterm neonates ≤ 32 weeks and postmenstrual age (PMA) ≤ 36     weeks.      Preterm neonates born at ≤ 32 weeks with PMA≤ 36 weeks who require feeding tube as a route     for enteral feeding once they are out of respiratory support ( i.e ventilation or CPAP) are     eligible candidates. Feeding tube insertion episode (FTIE) is defined as episode of insertion     of OG or NG tube. FTIE will be randomized into NG or OG routes. Primary outcome is frequency     of desaturation and bradycardia in each group.   "
16159|NCT03073980|"     This research study is being done to compare how effective certain medications are at     reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the     time between the retrieval and discharge from the hospital. The investigators will compare     intravenous (IV) acetaminophen (Tylenol) to oral (PO) acetaminophen with IV fentanyl and to     IV fentanyl only. The investigators also want to find out whether IV acetaminophen can reduce     a person's need for opioid pain medications (such as morphine) to rescue breakthrough pain.   "
16160|NCT03073967|"     Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in     immunocompromised subjects with acyclovir resistant mucocutaneous HSV infection, treated with     pritelivir 100 mg qd (following a loading dose of 400 mg as first dose to rapidly reach     steady-state plasma concentration) or foscarnet 40 mg/kg iv tid/60mg/kg iv bid.   "
16161|NCT03073954|"     General cognitive impairment is highly prevalent in chronic obstructive pulmonary disease     (COPD) patients. Domain-specific cognitive impairments include deficits in domains such as     cognitive flexibility, verbal memory, working memory, planning, and psychomotor speed; which     in general are associated with poor health behaviours, such as infrequent exercising and poor     diet. Additional cognitive training may reverse these effects. Recent evidence suggests that     working memory training is linked to self-control and, indirectly, to improved lifestyle     behaviour including increased physical activity. The investigators hypothesise that enhancing     cognitive performance through administering specific working memory training not only     improves cognitive function but that it facilitates better adherence to a more active     lifestyle and a healthier diet in COPD patients.   "
16162|NCT03073941|"     A multicenter, prospective randomized controlled trial comparing the Persona knee system to     the Nexgen knee system in total knee arthroplasty.   "
16163|NCT03073928|"     One hundred and twenty patients will be randomized to Interscalene block or Paracoracoid     Subscapularis plane block. The study will evaluate the efficacy and duration of blocks in the     2 groups with regards to postoperative analgesia and degree of respiratory depression.   "
16164|NCT03073915|"     Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend     the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE.     Yet several retrospective studies have shown that the compliance with this guideline is low.     Physicians are often reluctant to administer LMWH to their fragile patients mainly because     they are not convince that the risk associated with such therapy is greater than the risk for     VTE.      In the current study, data concerning the use of thromboprophylaxis among patients admitted     to the medical wards will be collected. The occurrence of bleeding or thrombotic event will     be evaluated prospectively.   "
16165|NCT03073902|"     The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has     an important role in guiding for the treatment of immune detection point. At the same     time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the     information of tumor tissue,PD-L1 expression in serum and peripheral blood T cell are     expected to be simple, rapid, non-invasive means of detection. The project is planned to     explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral     blood T cell and serum..The investigators have designed to detected the expression levels of     PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral     blood T cell and serum.By using variance analysis of repeated measures design information.     Thus exploring the correlation of PD-L1 expression in non-small lung cancer tissue and     peripheral blood T cell and serum,guiding clinical practice of immunotherapy.   "
16175|NCT03073772|"     Many patients with exhaustion disorders continue to have significant difficulties with     attention and memory function which reduce their work ability. This randomized study     investigates whether the addition of a 12-week period of specific cognitive training or     physical fitness training could further enhance cognitive function in patients with     exhaustion disorder participating in a multimodal rehabilitation program.   "
16176|NCT03073759|"     This study will be performed in patients with peripheral neuropathy who are walking     independently, but have complains of balance problems such as recent falls or difficulty     walking and show reduced vibratory and proprioceptive sensation during routine neurologic     examination. These patients will be tested for proprioceptive and vibratory threshold at the     toes and ankles before, during and after receiving anodal direct transcranial cortical     stimulation (dTCS) over sensory and motor cortices. Subjects will be asked to participate in     2 sessions.   "
16380|NCT03071068|"     This study is conducted to evaluate the safety of THR-317 when administered intravitreally     and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and     reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular     oedema (DME).   "
16232|NCT03073018|"     The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was     designed to determine whether intervention with the angiotensin-converting enzyme (ACE)     inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor     pravastatin reduced cardiovascular and renal events in nonhypertensive,     nonhypercholesterolemic subjects with microalbuminuria.   "
16166|NCT03073889|"     Forty ASA I or II patients, scheduled for aneurysm clipping were enrolled in this     prospective, randomized, controlled study. Those patients were randomly divided into 3     groups: Group B (Scalp nerve block before skin incision n=15), Group I (Scalp infiltration     before incision n=15), respectively with 0.75% of ropivacaine, and Group C (the control     group, n=15). Opioids were used to control haemodynamic responses.All patients received the     same general anesthesia.      After intubation, in group B, scalp block was performed by blocking the nerves that innervate     the scalp, including the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal,     greater occipital and lesser occipital nerves, and skin along the incision was infiltrated     with 0.75% ropivacaine (group I, n = 15), respectively. For group C, there is no treatment.     All patients received the same general anesthesia. The depth of anaesthesia was adjusted to     maintain a BIS of 40-60. Characteristics of patients were recorded. Heart rate (HR) and mean     arterial pressure (MAP) were recorded preoperatively, after induction, before skin incision,     the moment of incision, after skin incision. Plasma levels of IL-6, IL-10, CRP were measured     before surgery, skin incision,after the surgery. Postoperative pain scores (VAS) for 2, 4, 8,     12, 24, 48 hours after recovery of consciousness were also recorded. Postoperative     complications ( nausea, vomiting, infection, and other adverse events) were monitored after     surgery.   "
16167|NCT03073876|"     Acetylcholinesterase inhibitors (AChE-I) comprise a class of drugs used to treat Alzheimer's     disease (AD), but controversy about their usefulness remains. Modest response rates of     treated versus placebo groups, small effect sizes with respect to efficacy, drug costs, and     clinical relevance of the effects are problematic. Standard efficacy measures of efficacy are     not sufficiently sensitive, and trying to assess cognitive change after 4-6 months of therapy     confounds the drug effect and the natural progression of the disease.      Surprisingly, attention has never been included in the assessment of AChE-I drugs. The     rationale for using attentional measures are that (1) Attentional deficits are recognized as     a critical cognitive change in the earliest phases of AD; (2) Attentional function is     directly mediated by the cholinergic system, and responds rapidly to cholinergic     augmentation, particularly on tasks that tax available attentional capacity are dose     dependent; and (3) Acetylcholine is depleted in AD. However, the link between attention and     cholinergic depletion in AD has not been fully explored, especially with regard to response     to cholinergic treatment.      The study tests if attentional performance can be a more sensitive marker of response. In a     longitudinal study we measure attentional, as well as cognitive and behavioral performance in     de novo AD patients undergoing donepezil treatment. The investigators develop visual     attentional measures and contrast them to global and domain-specific cognitive scores on     three occasions (T1) baseline pre-treatment, (T2) after approximately 6 weeks, and (T3) after     6 months treatment. The T1-to-T2 arm is a double-blind placebo control period, after which     members of the placebo group start open-label treatment. The assessment at 6 months allows us     to determine whether the changes seen earlier at T2 can predict patients who respond, or     determine which measures best predict response.      We hypothesize that attention measures are more sensitive than standard global measures or     other cognitive domains and that the change of attentional function can be detected after     only after approximately 6 weeks treatment.      Knowledge from this project will facilitate and inform our decisions about individual     patients undergoing pharmacological treatment.   "
16168|NCT03073863|"     Epidemiological studies have shown that serum cholesterol level is correlated with     Cardiovascular Disease (CVD) risk, and that Cardiovascular Disease (CVD) risk increases with     increasing LDL cholesterol levels. Fortunately, it has been confirmed that     cholesterol-lowering therapy is effective in preventing Cardiovascular Disease (CVD), and     cholesterol lowering with statin therapy is a primary strategy in the prevention of     Cardiovascular Disease (CVD). Despite the fact that statins reduce both LDL cholesterol and     future cardiovascular outcome, the association of statin intensity and the achieved level of     LDL cholesterol with cardiovascular outcome has not been fully elucidated, because statins     have pleiotropic effect as well as LDL lowering effect.      The effect of statin on future Cardiovascular (CV) outcome seems to be more associated with     statin intensity relating pleiotropic effects rather than with achieved LDL cholesterol     level, because LDL-lowering by inhibition of hepatic cholesterol synthesis is linked to     reciprocal increment of cholesterol absorption from the intestine.   "
16169|NCT03073850|"     The purpose of the study is to investigate the best strategy for long-term stroke prevention     in patients who have sinus rhythm after a successful catheter ablation for atrial     fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The     investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with     different doses of edoxaban (30mg and 60mg).   "
16170|NCT03073837|"     This pilot study will utilize the experimental rhinovirus infection model to study changes in     skin microbiota in relation to skin erythema and soreness.   "
16171|NCT03073824|"     An open-label long-term evaluation of a novel intravaginal device in female patients     experiencing sexual and bladder function issues.   "
16172|NCT03073811|"     This research study will be conducted in two parts. The first part will consist of selecting     appropriate screening and assessment tools for Veterans undergoing elective surgery and     identifying the number of Veterans who are malnourished and at risk of malnutrition. The     second portion of the study will be to determine if a protein-enhanced diet before and after     surgery will improve function and postoperative outcomes and compare the results to an     education control group.   "
16173|NCT03073798|"     Specific Aim: To determine the effectiveness of Roflumilast in improving i) whole right lung     and ii) peripheral right lung mucociliary clearance (MCC) in patients with COPD and chronic     bronchitis.      Hypothesis: Roflumilast increases mucociliary clearance in patients with chronic bronchitis.      Study Design: This will be a double-blinded, cross-over randomized controlled trial with 1:1     randomization of 20 individuals with chronic bronchitis. Subjects will undergo baseline MCC     then will be randomized to either roflumilast or placebo x 4 weeks, then there will be a 4     week wash-out phase and a second 4 week period of roflumilast/placebo depending on initial     randomization. MCC will be conducted at baseline and at the end of each 4 week medication     phase.   "
16174|NCT03073785|"     This randomized phase II trial studies how well hypofractionated stereotactic body radiation     therapy and fluorouracil or capecitabine with or without zoledronic acid work in treating     patients with pancreatic cancer that has spread from where it started to nearby tissue or     lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation     therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor     using smaller doses over several days and may cause less damage to normal tissue. Drugs used     in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer     symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated     stereotactic body radiation therapy and fluorouracil or capecitabine with or without     zoledronic acid may work better in treating patients with pancreatic cancer.   "
16177|NCT03073746|"     There are large differences in knowledge between patients and healthcare providers (i.e.     physicians, physician assistants and nurse practitioners), and there is a strong interest on     the part of both industry and academia to reduce the gap in knowledge between patients and     healthcare providers. Currently, about 1 in 20 searches on Google are health related. Among     internet users, 72% reported searching for health information, and among persons who use     mobile phones, 31% of cell phone users and 52% of smartphone users have looked up health or     medical information. Oftentimes, patients will search on Google or other search engines in     order to find health conditions that explain their symptoms prior to visiting their     healthcare provider. With the launch of Google's new health search tools for mobile devices     (i.e. smartphones, tablets, etc.) it is important to understand how patients use these search     platforms and what their effects are on clinical encounters. The main objective of this study     is to understand the accuracy of differential diagnoses generated by Google searching; the     investigators hypothesize that searching on Google using a tablet or mobile device will be     more accurate than not using any search tool, and that the new health search experience will     improve accuracy over the standard search platform.   "
16178|NCT03073733|"     This study evaluates the changes in visual function at 12 months following a single injection     of human retinal progenitor cells compared to untreated controls in a cohort of adult     subjects with RP.   "
16179|NCT03073720|"     To determine the correlation between bioavailable Vitamin D values and euploid status of the     embryos in larger size follicles from UAE women undergoing in vitro fertilization procedures.   "
16180|NCT03073707|"     Bloodstream infections caused by non-typhoid Salmonella (NTS) are a major killing disease in     Sub-Saharan Africa. Despite the high case fatality rate, the main reservoir -human, zoonotic     or environmental- for invasive NTS rests unknown.      The main objective of this study is to assess        1. the household environment (household member, cattle and pets, rats) for intestinal          carriage of NTS and        2. the household water supply for presence of NTS .      Households of children with proven NTS invasive infection will be addressed.   "
16181|NCT03073694|"     The purpose of this trial is to compare the morbidity and mortality of CRS-HIPEC using     mitomycin-C versus melphalan for colorectal peritoneal carcinomatosis. Morbidity and     mortality will measured using the Comprehensive Complication Index (CCI) score, Common     terminology criteria for adverse events (CTCAE version 4.03), and the Clavien-Dindo     Classification.   "
16182|NCT03073681|"     Patients implanted with the ReSTOR 2.5 multifocal IOL in the dominant eye and the ReSTOR 3.0     in the non-dominant eye have overall satisfaction and spectacle independence at least     comparable to that with bilateral implantation of the 3.0 add lens. Glare and haloes and     other unwanted visual side effects with this mixed combination of lenses is better than with     bilateral 3.0 lenses.   "
16183|NCT03073668|"     The researchers are doing this study to find out whether there will be less increase in     cardiac filling pressure after the surgeon opens the pericardium (the membrane around the     heart) than when the pericardium is intact. The researchers want to see whether opening the     pericardium is an effective way to reduce the blood filling pressures in the heart.   "
16184|NCT03073655|"     The aim of the study to investigate the effectiveness KT application with different verbal     inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear.   "
16185|NCT03073642|"     Fibromyalgia (FM) is a prevalent and disabling disease, that affects mostly women and its     main characteristic is chronic pain. Several studies have shown that hydrotherapy is     effective in the improvement of symptoms and quality of life of this population; other     studies have shown that Pain Therapeutic Education (PTE) is also effective in this sense. PTE     is one cheap, easy to apply intervention, with very positive results in chronic pain     situations. However, there is a lack of studies that have shown the effects of this     intervention on FM. Hence, this study will aim to verify the effectiveness of the     hydrotherapy and PTE on women with FM. Sixty women will be randomly allocated in two groups:     hydrotherapy and hydrotherapy + PTE. Before treatment start, the investigators will evaluate     pain (visual analogue scale, presence of myofascial trigger points and pressure pain     threshold over the scalene, upper trapezius, infraspinatus, piriformis, iliopsoas and soleus,     bilaterally), quality of life (Fibromyalgia Impact Questionnaire and medical outcomes study     36-item short-form health survey), depression (Beck Depression Inventory), anxiety (Beck     Anxiety Inventory) and sleep quality (Pittsburgh Sleep Quality Index and Epworth Sleepiness     Scale). Hydrotherapy treatment will last 12 weeks. Women will be evaluated other 3 times:     after 6 and 12 weeks (treatment middle and end) and 12 weeks after treatment completion     (follow-up). Women in the hydrotherapy group will receive a folder with explanations on FM.     Women in the hydrotherapy + PTE will participate of 4 meetings over 12 treatment weeks, in     which themes like pain physiology, pain chronification and exacerbation and pain     self-management, as well as information on FM will be approached. Statistical analysis will     include qualitative and quantitative variable description. Correlation among variables will     also be analyzed. Level of significance will be set at 5%.   "
16186|NCT03073629|"     Millions of Americans seek emergency care for acute shortness of breath, and many undergo     computerized tomographic pulmonary angiography (CTPA) testing that is negative for acute     disease. Management of patients with persistent shortness of breath despite normal testing     continues to pose a challenge for clinicians. Right ventricular (RV) failure is a common     cause of dyspnea that brings patients to the emergency department (ED), however, it is often     not considered in the differential diagnosis, remains unrecognized, or patients are not     properly followed up once diagnosed. Delays in diagnosis and management of RV failure are     associated with poor outcomes. The investigators propose a novel clinical pathway, which     entails identifying and enrolling patients with RV failure in the ED, then referring them to     a specialized cardiovascular clinic where they will receive a standardized evaluation and     management plan. Our hypothesis is that management of RV failure, through this pathway, will     improve patient outcomes when compared to standard care. The primary outcome will assess     1-year unscheduled healthcare visits.   "
16187|NCT03073616|"     This study will be conducted to determine the advantages and limitations of sonography     compared with chest radiography, in the detection of post procedure iatrogenic pneumothorax     in patients underwent to Pectus Excavatum (PE) with Nuss repair.   "
16188|NCT03073603|"     Natural history research in MS suggests that risk of relapses and new Magnetic Resonance     Imaging (MRI) changes diminish significantly as people age, especially in MS patients 55 or     older. Thus, the need to continue MS medicines that reduce relapses and new MRI lesions may     also decrease as people age, especially in those who have not had relapses or MRI scan     changes for prolonged times. This study plans to learn more about the safety of stopping MS     medication in this population, as compared to continuing on the medication.   "
16381|NCT03071055|"     This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for     patients with retinal fluid due to exudative macular degeneration refractory to monthly     therapy.   "
16190|NCT03073577|"     Islet Transplantation is a procedure used in people with difficult to control Type 1     Diabetes. Insulin producing cells (islets) are isolated from a deceased donor pancreas. After     the cells are carefully isolated from the donor pancreas, the islets are transplanted into     the recipient's liver. These transplanted islets may produce insulin.      One of the challenges with islet transplant is the death of some of the transplanted islets     due to inflammation, oxidative stress and exposure to diabetogenic immunosuppressive agents     associated with islet functional impairment and graft loss, especially linked to the use of     calcineurin inhibitors, including tacrolimus (Tac).      Antiaging glycopeptide (PKX-001) is a small, stable, synthetic replica of antifreeze proteins     (AFPs), which naturally occur in Arctic and Antarctic fish and have been shown protecting     cells against harmful conditions. PKX-001 is a new drug that has been shown in lab studies to     help islet cells survive isolation and keep them healthy and functioning. Most importantly,     animal studies have shown that islets treated with PKX-001 were protected from the     immunosuppressant (Tac) toxicity and retained their function in animals receiving islet     transplant.      This study will involve up to 10 participants from the islet transplant waiting list at the     Clinical Islet Transplant Program. All participants will receive islets treated with the     medication PKX-001. PKX-001 will be used only in the islet preservation process, and will not     be given to participants as medication.      The purpose of this study is to confirm the safety of transplantation of PKX-001 treated     islets and to evaluate the cytoprotective capacity of PKX-001 in islet transplantation,     especially its capacity to protect against Tac induced graft dysfunction.   "
16191|NCT03073564|"     The study will evaluate the effect of positive airway expiratory pressure (EPAP) on patients     with chronic obstructive pulmonary disease (COPD) during submaximal upper limb exercise.   "
16192|NCT03073551|"     Gestational diabetes mellitus (GDM) affects up to 3-5% of all pregnancies. When diagnosed     with GDM, women undergo nutritional counseling, blood sugars monitoring and are encouraged to     exercise regularly. Women who do not meet therapeutic targets may need to add insulin     injections. Activity promoting video games are an attractive possibility for improvement of     exercise compliance. The objective of this study is to determine whether providing women     recently diagnosed with GDM with a Nintendo Wii™ activity promoting gaming platform will     increase activity levels, improve glycemic control of sugar levels and decrease the need for     supplementary insulin treatment.   "
16193|NCT03073538|"     Untreated maternal infection with gonorrhea and/or chlamydia can have serious complications     in pregnancy and the neonatal period. In Ontario, routine screening for these infections is     done in the first trimester of pregnancy, positive cases are treated with antibiotics, and     all newborns are given antibiotic eye ointment within 24 hours of birth. Recently, the     Canadian Pediatric Society recommended stopping universal prophylaxis for newborns, with     instead, focus on screening and treatment of these infections in pregnancy. Given that these     infections can occur at any time in pregnancy, and exposure at delivery provides a     significant risk to infants, more information is needed about the rates of infection     throughout pregnancy and health-care provider compliance with guidelines to make this change     without undue risk. With this information optimal timing of testing can be evaluated.   "
16194|NCT03073525|"     This is a crossover study of Vigil, Atezolizumab and their combination in patients who have     tumor harvested at surgery and successful manufacturing of Vigil but are ineligible for     CL-PTL-119 (the VITAL study).   "
16195|NCT03073512|"     Preterm birth still remains a major cause of perinatal morbidity and mortality worldwide. The     exact mechanism stimulating term and preterm births in humans is still unknown.     Prostaglandins, by mediating cervical ripening and early stimulation of myometrial     contractions, are likely to play a major role in the parturition process. Much of the unique     fetal circulation is facilitated by the ductus arteriosus. Patency of the ductus arteriosus     in utero is primarily maintained via prostaglandins which are highly expressed by smooth     muscle cells located in the media of the ductus arteriosus. The primary objective of this     study is to prospectively assess whether any changes in the fetal ductus arteriosus     parameters exist at 32 weeks' gestation. The secondary objective is to investigate whether     there is an association between the ductus arteriosus parameters and the time to delivery     interval at 32 weeks' gestation.   "
16196|NCT03073499|"     This pilot study aims to evaluate the sensitivity, variability and responsiveness of a number     of predefined clinical and psychological outcome measuring tools in an ambulant cancer     treatment setting (home vs. hospital). The measuring tools will be evaluated in two patient     cohorts. One cohort is treated as per standard of care at the outpatient hospital, the other     cohort is receiving (partial) cancer treatment at home. A second objective is to create a     costs inventory representing total costs for an ambulant treated cancer patient.   "
16197|NCT03073486|"     The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil     Gel compared to vehicle in patients with acne vulgaris   "
16264|NCT03072589|"     This study will evaluate the maximum safe dose and duration of regadenoson (Lexiscan) that     can be given to people who are having a lung transplant. Regadenoson will be given as a     continuous IV infusion. All participants in the study will receive a regadenoson infusion     beginning in the operating room during the lung transplant procedure. Participants will be     assigned a certain dose of regadenoson to be given over a 12 or 24 hour period.   "
16198|NCT03073473|"     Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor     utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains     unclear if these new diagnostic technologies truly influence clinical and economic outcomes.     This study will evaluate if patients treated according to the results of the NantHealth GPS     Cancer test achieve optimal outcomes compared to patients whose treatment are discordant with     GPS Cancer recommendations.   "
16228|NCT03073070|"     HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a     marker of increasing importance both for assessing glycemic control in children with known     diabetes and for the diagnosis of diabetes in children. HbA1c has demonstrated poor     reliability in diagnosis and management of pediatric diabetes and the most plausible reason     for this unreliability is that the reference ranges of HbA1c were established based on     120-day RBC lifespan observed in adults, without considering the RBC lifespan difference     between children and adults. The proposed studies will for the first time determine RBC     lifespan in diabetic children   "
16199|NCT03073460|"     The exact mechanism stimulating the parturition in humans is still relatively unknown.     Prostaglandins, by mediating cervical ripening and early stimulation of myometrial     contractions, are likely to play a major role in the parturition process. Much of the unique     fetal circulation is facilitated by the ductus arteriosus. Patency of the ductus arteriosus     in utero is primarily maintained via prostaglandins which are highly expressed by smooth     muscle cells located in the media of the ductus arteriosus. The aim of the study is to     prospectively observe fetal ultrasound changes related to the ductus arteriosus. The primary     objective is to prospectively assess, whether any changes in the fetal ductus arteriosus     parameters exist at 40 weeks' gestation. The secondary objective is to investigate whether     there is an association between the ductus arteriosus parameters and the time to delivery     interval at 40 weeks' gestation.   "
16200|NCT03073447|"     MI in elderly women seems to share the same pathophysiology than in men, especially plaque     rupture associated with conventional risk factors. Therefore the questions is not solved on     the pathophysiology and specific risk factors in young women whose prognosis is more severe.     A complete descriptive analysis appears mandatory to understand the peculiarities, including     not only morphological but also biological explorations as well.      To date no systematic descriptive analysis has been performed including clinical     characteristics, cardiac and extra-cardiac morphological exploration and hormonal and     immunological assays, particularly in young premenopausal women presenting MI.      This study will provide for the first time a complete analysis, including hormonal assays,     never made in an acute population.      The main objective of this clinical study is to systematically pool clinical, morphological     and biological data of young women (< 50 years) presenting an Acute MI and to assess their     short-term (in-hospital) and mid-term (12 months) prognosis. The definition of MI is the one     adopted in the Third definition published in 2012. As such an event occurs in a young     patient, diagnostic and treatment may vary among centres. The incidence of such cases in each     centre being low and practice inhomogeneous, no conclusion could be advanced concerning the     study of associated, indeed predisposing factors.      The work aims to comprehensively and systematically collect all the clinical and laboratory     data and the results of the all morphological explorations carried out during the care of     these young women admitted for acute MI in high-volume centres.      No additional invasive act, without any direct benefit for the care of patients will be     realized for research purposes.      All these examinations, in particular invasive morphological, are more and more integrated in     the practice of modern interventional cardiology especially for complex or infrequent     situations, like this setting. They afford accurate diagnosis of coronary disease on one hand     and on the second hand they determine the causal or at least participating factor.      A comprehensive and systematic analysis of this particular entity that is MI in young woman,     would improve our knowledge of this disease and then enable to offer patients a more     appropriate treatment and monitoring. It is necessary to progress in the understanding of the     mechanisms of the early onset of coronary artery disease in its most acute and most serious     presentation and to clearly define the specificities of coronary disease in young women.     Moreover, a more precise identification of risk factors of MI in a woman under 50 will allow     a better screening and even introduction of preventive strategies.   "
16201|NCT03073434|"     This is a retrospective study involving all patients with a history of renal transplant that     attended antenatal clinics at various Toronto hospitals and subsequently delivered between     January 2000 and December 2014.      The purpose of this study is to describe the incidence of adverse pregnancy-and     transplant-related outcomes, and report placental ultrasound and placental pathology findings     in renal transplant recipients with contemporary standards of care in Toronto.      This study also seeks to determine whether factors such as maternal age,     transplant-to-pregnancy interval, hypertension, diabetes mellitus, treatment regimens, and     the primary cause for renal failure are associated with higher risk of adverse pregnancy     outcomes in renal transplant recipients.   "
16202|NCT03073421|"     The Positive Pregnancy Program is an innovative, unique, interprofessional model of care for     HIV-positive pregnant women. This program has been in place at St. Michael's Hospital for     five years. This study is important because it will allow for a critical evaluation of the     Program, and to identify strengths and weaknesses. This will in turn provide the opportunity     to improve delivery of care for HIV positive women.   "
16203|NCT03073408|"     The action of anesthetics such as propofol is not immediate after intravenous administration.     Delay in pharmacodynamic effect of intravenous drugs is a commonly observed phenomenon in     total intravenous anesthesia (TIVA). On the other hand, the measure of the clinical effect of     propofol by EEG processed monitors like the bispectral index (BIS) also requires some     processing time for the analysis of the recorded signal. Thus, the resulting BIS value     provided by the monitor is affected by a delay. When a BIS based controller is used, the     propofol infusion rates are defined using information of the BIS signal available. The delay     in the BIS signal is an important issue as it can affect the performance of the controller.     There are scarce contributions to address the delay in automatic administration of     anesthesia.      Our proposal to deal with the dead time in the control action of the hypnotic component of     anesthesia is a proportional-integral (PI) algorithm with a Smith predictor. The aim of this     study is to evaluate and compare the feasibility and effectiveness of a closed-loop control     using the Smith predictor versus manual control for propofol administration guided by the     bispectral index (BIS) in adults patients. The objective is to show that a closed loop     control can be a useful tool to provide safe and effective intravenous anesthesia and that     the use of specific controller for delay rejection is a reliable strategy.   "
16204|NCT03073395|"     An early phase I study to evaluate the uptake of [68Ga]P16-093 in known or suspected     metastatic prostate or renal cancer to establish the feasibility of using [68Ga]P16-093 to     image PSMA expressing cancer. Measurement of the whole body biodistribution of [68Ga]P16-093     in man to generate human radiation dosimetry data.   "
16205|NCT03073382|"     This is a chart review of all patients who have underwent open prenatal repair of fetal     myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes     and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is     preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk     factors associated with preterm delivery.   "
16218|NCT03073213|"     The purpose of the study is to research how much ixekizumab enters the bloodstream and how     long the body takes to get rid of the drug and the safety of ixekizumab and any side effects     that might be associated with it. The study has two parts: A single-dose part and     multiple-dose part. The single dose part of this study will last up to 24 weeks, including     the screening period. The multiple dose part of this study will last up to 32 weeks including     the screening period.   "
16229|NCT03073057|"     The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.   "
16230|NCT03073044|"     The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled     out the questionnaire   "
16231|NCT03073031|"     This study evaluates if melanoma patients who report their side effects to immunotherapy     weekly by the use of ePRO-CTCAE will experience an overall reduction of grade 3 and 4 events     with 50% compared to routine monitoring carried out every 3 weeks.   "
16206|NCT03073369|"     The purpose of the study is to learn more about how treatment with vitamin D can affect iron     metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with     chronic kidney disease (CKD).      Iron is an essential mineral which is a major component of proteins that carry oxygen in the     blood. Problems with iron metabolism can lead to low blood levels (anemia), which can     commonly happen in people with CKD.      New research over the last decade has uncovered a new hormone called `hepcidin', which is     made in the liver and released into the blood. Hepcidin controls how much iron is in the     blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to     be high in people with CKD, and a recent small study in people with normal kidney function     showed that treatment with vitamin D decreased hepcidin levels.      In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol)     on iron metabolism and blood levels of hepcidin in individuals with CKD.   "
16207|NCT03073356|"     Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present     study, healthy test subjects and patients with heart failure with reduced ejections fraction     will be investigated in a randomized cross-over design with ketone infusions and placebo.     Myocardial efficiency and hemodynamics will be evaluated.   "
16208|NCT03073343|"     Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States     without a prescription. In this study, betaine will be provided to patients as a powder that     can be mixed with aqueous solutions and consumed orally.   "
16209|NCT03073330|"     Our study will assess if there is a difference in incidence of gestational diabetes using     different screening approaches, either using a one-step approach with a 2 hour glucose     tolerance test or using a two-step approach. Prior studies have proven similar incidences     including a randomized controlled trial.   "
16210|NCT03073317|"     Investigators will test a novel system of integrated care, to promote the use of the WORLD     HEALTH ORGANIZATION Guidelines for the management of pre-eclampsia and initiate the use of a     structured risk assessment strategy to reduce the incidence of preterm delivery from     pre-eclampsia by providing obstetricians with the confidence to safely defer delivery of     women with pre-eclampsia, identified to be of low risk.   "
16211|NCT03073304|"     The primary aim of this study is to investigate the possibility to replace an erythrocyte     based prime solution with a crystalloid based prime solution while maintaining metabolic     function. Secondary also to study if potentially reduced immunological influence is obtained     during hyper thermic isolated limb perfusion with a crystalloid based prime solution.   "
16212|NCT03073291|"     The legalization of recreational marijuana use and sales in Alaska, Colorado, Oregon, and     Washington State is a dramatic change in U.S. substance abuse policy that places a priority     on developing regulatory and enforcement systems that prevent distribution of retail     recreational marijuana to minors. Responsible marijuana vendor training, modeled after     effective responsible alcoholic beverage training, has the potential to help the states     prevent distribution to minors. This research will produce a responsible marijuana vendor     training provided by a third party, not the cannabis industry, and test its effectiveness     with retail recreational marijuana licensees and employees in Colorado, Oregon, and     Washington State.   "
16213|NCT03073278|"     To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment     (SBRT) for locally recurrent prostate cancer.   "
16214|NCT03073265|"     The objective is to demonstrate the performances of STA® - Apixaban Calibrator & STA® -     Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban     concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography -     mass spectrometry) for validation of the assay. For this study, the anti-Xa assay will be     performed on fresh samples only.      The results will be used to complete results obtained previously on frozen samples.   "
16215|NCT03073252|"     The primary purpose of this study is to explore the effect of high versus normal egg-based     protein meals on acute exercise-induced elevated blood pressure.   "
16216|NCT03073239|"     Amyotrophic Lateral Sclerosis (ALS) is a degenerative neuromuscular disease, progressing     inexorably to respiratory failure, the by involvement of respiratory muscles, the commitment     with most impact on the prognosis of ALS.      According to current knowledge, the clinical presentation of the disease is characterized by     spinal or bulbar involvement, the latter being associated with a worse prognosis.      There are multiple factors described in the aetiology of ALS, as the successive damage the     motor neuron, which can happen in high-impact athletes, or exposure to heavy metals. Genetic     mutations are also described, being associated to a higher prevalence of ALS.      Data from retrospective studies with ALS populations reveal a prevalence of 4-8 cases per     100,000 persons. Research carried out in Trás-os-Montes e Alto Douro region (Northeast of     Portugal) shows a high prevalence of ALS, with near 10 cases per 100,000 persons, with a     recent increase in the bulbar involvement. The reasons for the high prevalence of ALS in this     region are unknown.   "
16217|NCT03073226|"     Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes.     People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have     regular checkups to detect changes before they progress to cancer. Every two years patients     with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus     (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory     to check for changes.      Bowel cancer is the third most common cancer in the UK, and the second leading cause of     cancer deaths. Prevention and early detection are the most effective strategies of dealing     with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are     common and have the potential of developing into cancer over the course of many years.      Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular     endoscopic examinations known as surveillance endoscopies. This is done to detect changes in     the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded     videos of Barrett's surveillance examinations and still images of polyps prior to their     removal.      Endoscope technology continues to advance. These newly developed technologies are marketed to     have claims of superiority in performance over preceding generations often without the back     up of scientific data but at a significant financial cost. The aim of this study is to use     endoscopic images and videos recorded as part of routine clinical practice to compare the     current version of Olympus endoscopes with the new version launched by the company.   "
16220|NCT03073187|"     The overall goal of this project is to develop and to preliminarily validate a novel     intervention to be delivered in the high school setting that integrates two evidence-based,     school-based interventions for urban adolescents with proven efficacy: (1) Asthma     Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled     asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and     behaviors in urban adolescents.      The aim for Phase I is to develop and integrate school-based interventions to improve asthma     self-management and sleep hygiene in urban high school students via interviews.      The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the     intervention procedures; and (2) to assess the preliminary evidence of the effects of the     intervention on improving sleep quality in urban high school students with persistent asthma     over a 2-month follow-up period.      This record is for Phase I only.   "
16221|NCT03073174|"     A previous study, on which this study is based, found that a diet higher in fruits and     vegetables, beta-carotene, vitamin C, alpha-tocopherol, and fish oils (specifically     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) was positively associated with     periodontal healing after sanative therapy (NCT02291835). The investigator's next step, in     the present study, is to determine long-term benefits of sanative therapy in which patients     have regular maintenance hygiene cleanings on periodontal health. Specifically, the     relationship between intakes of specific foods, nutrients and supplements with clinical     periodontal outcomes will be studied.   "
16222|NCT03073161|"     Periodontitis is a chronic inflammatory disease that, if untreated, will lead to tooth loss.     To treat periodontal disease, sanative therapy is used as a first line cost-effective     strategy to manage periodontal disease and thus prevent tooth loss. Diet is emerging as a     modifiable factor that may help an individual to more fully respond to treatments such as     sanative therapy. Dietary flavonoids, abundant in fruits and tea, may be particularly     beneficial. Patients with moderate to severe chronic generalized periodontitis and undergoing     sanative therapy will be recruited for the study. Mean clinical attachment loss as well as     other clinical measures will be assessed at baseline and 8 to 12 weeks following sanative     therapy to measure periodontal healing. At baseline and follow-up appointment, the following     will be assessed to examine associations with clinical measures of periodontal healing:     intakes of macronutrients and micronutrients, fruits, vegetables and tea as well as     supplement use and salivary markers of inflammation.   "
16223|NCT03073135|"     This study aims to evaluate the effectiveness of psychodrama group therapy (PGT) compared     with supportive group therapy (SGT) for excoriation disorder (ED). Patients will be randomly     allocated for either PGT or SGT. The Skin Picking Scale Revised (SPS-R) will be the primary     outcome and emotional regulation measured by the Difficulties in Emotion Regulation Scale     (DERS) will be evaluated as a potential intermediator. The Clinical Global Impression Scale     (CGI); Beck Depression Scale (BDI); Beck Anxiety Scale (BAI), and the Social Adjustment Scale     (EAS) will assess secondary outcomes.   "
16224|NCT03073122|"     In the landmark Boston Circulatory Arrest Study, neurologic and developmental status was     measured following infant heart surgery and then prospectively at ages 1, 2.5, 4, 8, and 16     years, with findings of significant neurocognitive deficits and brain MRI abnormalities     regardless of operative management. To date, no study has evaluated the neuropsychological     and neuroimaging antecedents and correlates of well-being in adults with congenital heart     disease, a population now >1 million and projected to grow at 5% per year. The investigators     propose to study the Boston cohort at ages 24-29 years to assess the associations of adult     well-being with childhood and adolescent executive function, other measures of mental health     and cognitive function, adolescent brain MRI findings, and clinical variables; findings will     guide the design of interventions in childhood to optimize outcomes in adults with congenital     heart disease.   "
16225|NCT03073109|"     This study is aimed to describe the outcomes related to physical activity, activity of     disease, quality of life, work productivity and safety in Latin-American patients with     Rheumatoid Arthritis (RA) treated with tofacitinib or biological DMARDs after failure to     respond to conventional DMARDs in real-life conditions. This will be a non-interventional,     hybrid study (prospective and retrospective data collection) comparing tofacitinib to     biologic DMARD treatments in patients with RA after failure of conventional DMARDs. The     population will be composed by adult patients over 18 years of age diagnosed with RA and who     have been prescribed tofacitinib or any biological DMARDs.   "
16226|NCT03073096|"     Lymphedema is the build-up of lymph fluid in the body's tissue causing chronic, debilitating     swelling. This commonly occurs as a result of a disruption of the lymphatic system during     lymph node dissection surgeries. In melanoma patients, the incidence of lymphedema ranges     from 5-10% in the arms following an axillary dissection, and 28-40% in the legs following     groin dissection. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an     innovative microsurgical technique where blocked lymphatic vessels are drained into the blood     circulation by surgically creating a shunt between a lymphatic channel and a blood vessel     called a lymphatic-venous bypass. Recently, LYMPHA has been shown to prevent lymphedema when     performed at the time of nodal dissection. We propose a prospective pilot study evaluating     the practice of the LYMPHA technique for the primary prevention lymphedema at The Ottawa     Hospital. The novel use of the LYMPHA technique holds the potential to prevent lymphedema     rather than to attempt to treat it once it has already progressed and as a result will not     only improve the quality of life of the cancer patients, but also decrease health care costs     associated with treating lymphedema.   "
16227|NCT03073083|"     A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current     gold Standard treatment for young and active patients with instability, is a surgical ACL     reconstruction. However, there still is no consensus on which graft is best suited for     this.The aim of the current multi-center randomized controlled trial was to investigate the     hypothesis that an anatomic single bundle anterior cruciate ligament reconstruction with a     (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured     anterior cruciate ligament with a patella tendon autograft or a hamstringtendon autograft, in     terms of failure, measured 2 years postoperatively. Failure is defined gedefinieerd as     pathologicai laxity, complaints of knee instability in the absence of any pathological laxity     and/or discontinuïty ofthe graft on MRl or arthroscopy.   "
16233|NCT03073005|"     This study will evaluate the performance of a curriculum using medical simulators to train     patients with advanced heart failure and their caregivers to master the self-management of     ventricular assist devices (a device implanted into the heart to help circulate the blood).     The investigators expect this training will improve self-management skills, and reduce     VAD-related infections and re-hospitalizations. In addition to providing innovative training     to the patients and their caregivers, the study will advance our knowledge of the effects of     simulation-based training on patient self-management and safety.   "
16234|NCT03072992|"     The aim of this study is to assess benefits of treatment with intravenous Curcumin® (CUC-01)     vs placebo, in combination with paclitaxel chemotherapy, and to estimate the risk of adverse     events in patients with locally advanced and metastatic breast cancer.      This is a randomized, double-blind, placebo-controlled, two arms parallel group phase 2     clinical trial:      Group A, 75 patients, treatment with Curcumin (CUC-01, yellow solution), 300mg i.v. plus i.v.     Paclitaxel (colorless solution) 80 mg /m2 BS i.e., once weekly for 12 weeks.      Group B, 75 patients, treatment with Paclitaxel (colorless solution) 80 mg /m2 BS, i.v. plus     placebo i.v. solution (250 ml, yellow solution for masking/blinding), once weekly for 12     weeks.      Primary objective of the study:      To assess:        -  Efficacy of combined therapy with Curcumin ®, (CUC-01) and Paclitaxel vs Paclitaxel in          patients with advanced and metastatic breast cancer in terms of Objective Response Rate          (ORR) assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST).      Secondary objectives of the study:      To assess:        -  The safety of Curcumin+Paclitaxel combination compared to Paclitaxel+placebo treatment          by assessment of adverse effects.        -  Quality of life (QOL) in patient treated with Curcumin+Paclitaxel combination compared          to Paclitaxel+Placebo        -  Response duration in terms of Progression free survival (PFS), Time to Disease          Progression (TTP) and Time to treatment failure (TTTF)   "
16235|NCT03072979|"     Pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. The     investigators will conduct a single-arm prospective study to quantify the reduction in tumour     vasculature post-radiotherapy   "
16236|NCT03072966|"     Distress monitoring is an important issue in cancer survivors. However, conventional distress     screening is very difficult to perform. This study investigates the efficacy of wearable     device as a tool of distress monitoring in breast cancer survivors.   "
16237|NCT03072953|"     The purpose of this Phase 2a, open label, proof-of-concept clinical study is to assess the     efficacy and safety of etrasimod (APD334) in patients with Pyoderma Gangrenosum.   "
16238|NCT03072940|"     Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal     violence, increased muscle tone during REM sleep and the lack of any other neurological     disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of     the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and     neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in     the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the     investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex     with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with     those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a     clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision     tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T     magnetic resonance imaging.   "
16239|NCT03072927|"     This prospective longitudinal study will compare incidence rates of Medicare beneficiary     surgical and minimally invasive intervention post index procedure, as well as harms     associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a     control group of similar patients that have had a comparable procedure.   "
16240|NCT03072914|"     In the present study, we evaluated whether RIPC with RIPostC reduce the major     neurocomplication in patients undergoing STA-MCA anastomosis.   "
16241|NCT03072901|"     The purpose of the registry was to observe the safety and effectiveness outcomes for subjects     treated with the EndoBarrier in the post market setting where the product had Conformité     Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.   "
16242|NCT03072888|"     The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve     Stimulation (TENS) in patients after abdominal hysterectomy surgery.   "
16265|NCT03072576|"     Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis     will be interviewed for demographic and medical information, and then will be asked to     provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested     using conventional and investigational diagnostic tests for tuberculosis and rifampin     resistance.   "
16243|NCT03072875|"     The overarching goal of this research is to create a tool that could reduce suicide rates,     increase delivery of efficacious suicide interventions, and decrease overall costs associated     with suicidal behaviors. With this in mind, investigators intend to: (1) develop and     scientifically validate a relational agent for suicidal patients that delivers Collaborative     Assessment and Management of Suicidality (CAMS), an efficacious and cost-effective     intervention developed by David Jobes, PhD; and (2) to create an integrated software system     (CAMS Relational Agent System; CAMS-RAS) that assists medical personnel by synthesizing the     CAMS intervention findings into an easy-to-interpret report, providing empirically-derived     clinical decision support; (3) enhances the patient's coping capability by including     psychoeducational skills training modules for use during and after hospitalization; and (4)     automates the delivery of caring contacts, an efficacious and brief suicide prevention     intervention provided after discharge. The focus of participant recruitment will be Emergency     Departments (EDs), often the initial point of contact and where personnel must make the     decision whether to hospitalize or discharge the suicidal patient. Investigators will also     conduct testing in other medical and outpatient mental health settings to ensure public     health impact and commercial success.      Phase I project aims include: (1) creating an advisory board to guide the development of     CAMS-RAS; (2) iteratively design and develop relational agent (Dr. Dave) modeled after the     gestures, expressions, and mannerisms of CAMS treatment developer, David Jobes, PhD; and (3)     conduct feasibility tests to determine whether CAMS-RAS is acceptable, easy to use, and liked     by target end-users: acutely suicidal patients admitted to hospital EDs, psychiatric     inpatient units, and medical floors for treatment of injuries sustained during a suicide     attempt; hospital medical personnel, administrators, and other stakeholders including peer     advocates; and outpatient suicidal patients, clinicians and administrators.   "
16244|NCT03072862|"     The purpose of this study is to show that cochlear implant treatment improves the overall     health related quality of life and general well-being in elderly individuals.   "
16267|NCT03072550|"     Early feasibility study to determine if a three-treatment protocol with the RenewalNail™     plasma treatment system over a week will result in mycological cure and/or clear nail growth     on the treated hallux toe.   "
16245|NCT03072849|"     This study aims to determine whether or not early spirometric detection and management of     obstructive lung disease with combined fluticasone/azithromycin/montelukast therapy (FAM) can     attenuate declining lung function, prevent the development of bronchiolitis obliterans, and     improve patient outcomes following hematopoietic stem cell transplant.   "
16246|NCT03072836|"     The FLORACROHN project aims to compare gut microbiota of patients suffering from Crohn's     disease (CD) associated or not to spondylarthritis (SpA).      3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering     from SpA alone, patients suffering from CD and SpA.      Fecal microbiota will be determined by 16SRNA gene sequencing.   "
16247|NCT03072823|"     N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and     physical health by reducing membrane arachidonic acid (AA) and prostaglandin E2 (PGE2)     synthesis, which might be linked to the somatic manifestations physical morbidity, such as     Cardiovascular disease in depression. n-3 polyunsaturated fatty acids appears to be a     promising treatment that is safe, beneficial to patients with Cardiovascular disease and     depression. In this proposal, investigators aim the test the hypothesis that n-3     polyunsaturated fatty acids will be more effective than placebo in treating Cardiovascular     disease patients with major depression after 12 weeks of intervention.   "
16248|NCT03072810|"     This study aims to increase the well-being of individuals with chronic pain through a 4-week     online positive mindfulness programme. Each module, lasting 4 days, will include a daily     meditation and focus on a different aspect of positive psychology. This is a quantitative     study. The independent variable is participation in the programme. The dependent variables     are: wellbeing, mindfulness, pain severity, pain catastrophising and health quality of life.     There will be one experimental group who participate in the programme as soon as they are     recruited. There will be one control group who are put on a 'wait-list' to complete the     programme after an 8 week wait. Pre and post measures will be taken. Participants will be     recruited through NHS clinics in London and Oxford, including the Pain Management Centre at     Oxford University Hospitals (Churchill site) and INPUT at St Thomas's Hospital (which will be     participant identification centres).   "
16249|NCT03072797|"     The Beijing Hospital Atherosclerosis Study (BHAS) is a prospective, single-center,     observational cohort study performed at the Beijing Hospital in Beijing, China. Subjects     enrolled in this study will be the consecutive patients undergoing coronary angiography in     the hospital. Blood samples are taken immediately before the angiographic procedure. Clinical     and angiographic characteristics are recorded. All patients will have routine follow-up at 6     months and 1 year postprocedure, then yearly thereafter. Follow-up includes mortality,     myocardial infarction (MI), stroke, rehospitalization, coronary revascularization procedures,     life styles, and medication use. The primary end point for the study will be the major     adverse cardiovascular events (MACE), defined as death from any cause, nonfatal myocardial     infarction, nonfatal stroke and revascularization. This study has been reviewed and approved     by the Ethics Committee of Beijing Hospital. All enrolled individuals will be received     written notice of the intended use of their blood samples and provided written consent.      The major objectives of the BHAS Study are to (1) establish a prospective cohort and a     biological sample bank in ethnic Chinese with coronary angiography, (2) identify baseline new     biosignature profiles such as novel biomarkers via metabolomics approach associated with the     subsequent clinical events, (3) assess the use of molecular profiles from multiple platforms     (eg, genomics, proteomics, and metabolomics) integrated with readily available clinical     information for improved risk classification for cardiovascular events, and (4) provide     clearer understanding of underlying disease processes.   "
16250|NCT03072784|"     Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post     operative pulmonary function.   "
16251|NCT03072771|"     Based on the further need to improve progression-free survival (PFS) and overall survival     (OS) post autologous stem cell transplant (SCT) for DLBCL, the hematopoietic profile of     patients following auto-SCT, the activity of blinatumomab in DLBCL and its favorable toxicity     profile, the investigators propose a pilot study to test blinatumomab as consolidation     therapy post auto-SCT for patients with DLBCL.      The investigators hypothesize the blinatumomab consolidation will optimize the effector to     target (E-T) ratio and aid in the eradication of remaining tumor cells, leading to decreased     relapse and increased overall survival. In addition, since tumor burden will be at a minimum,     infusional toxicities including neurologic toxicities may also be limited. The purpose of     this pilot study is to study the feasibility and tolerability of blinatumomab consolidation     post auto-SCT for patients with chemo-sensitive DLBCL undergoing auto-SCT.   "
16319|NCT03071861|"     This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial.     Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on     the modified Sarnat neurologic examination at less than six hours of age. Participants will     be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth.     Neurodevelopmental testing (Bayley III and Gross Motor Function Assessment) will be performed     at 12-18 months of age.   "
16252|NCT03072758|"     Breastfeeding remains the optimal mode of feeding for infants younger than six months.     Exclusive Breast Feeding (EBF) among HIV-infected mothers has been shown to be associated     with a sustained and significant reduction in HIV transmission and has the potential to     reduce infant and under-five mortality.      Given the considerable authority among men as decision makers in sub-Saharan African, we may     be witnessing a missed opportunity to engage men in the education, awareness, and     decision-making for EBF. Understanding the role and impact of male partners on this     decision-making process require further examination to inform the development of effective     and sustainable evidence-based interventions to support the initiation and sustainment of     EBF.   "
16253|NCT03072745|"     The aim of the present study is to examine cognitive function in a patient population with     complex chronic pain to test the hypothesis that insomnia severity on its own predicts     objective cognitive function, and that a correlation is not better explained by comorbid     depression or anxiety, morphine equivalent daily dose, or the level of pain itself.   "
16254|NCT03072719|"     A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site     study in subjects with at least two sensitive teeth to compare the efficacy of a test     dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.   "
16255|NCT03072706|"     Total hip replacement is one of the most successful surgical procedures of modern times, with     over 80,000 performed each year in the UK. However, up to 5% of all primary hip replacements     need to be revised within the first 10 years, and in many cases malposition of the acetabular     (hip socket) component is implicated in the early failure.      The standard method of positioning the acetabular component is for the surgeon to be guided     by a combination of the visible anatomical landmarks within the surgical field, and the wider     environment of the operating theatre. The advent of 3D printing has led to the development of     custom-made surgical guides which can be used during surgery, in order to assist the surgeon     in the positioning of instruments and devices. These surgical guides are manufactured based     on CT or MRI imaging, and are designed to clearly indicate to the surgeon the desired     location and orientation of bony cuts and implant positions.      This study will test the hypothesis that an acetabular alignment guide combined with     three-dimensional CT-based planning using the Corin OPS™ (Optimised Positioning System),     provides more accurate component alignment following primary total hip replacement compared     with the current standard treatment, with the aim of improving patient outcomes and reducing     the risk of complications of total hip replacement.   "
16256|NCT03072693|"     Background: Despite the advances in pharmacological management of heart failure (HF), the     associated mortality and re-hospitalization for HF remain poor. This is at least partly due     to suboptimal early discharge care, delayed detection of HF complications, and     underutilization and under-dosing of evidence-based HF medications. Mobile technology has     revolutionized inter-personal communication allowing instantaneous, multi-directional, and     massive data transfer. Nonetheless the potential of these enhanced communications have not     been fully explored in the management of patients with HF.      Objective: To explore the potential of state-of-the-art mobile technology for home-based     remote HF management in order to reduce HF mortality and HF re-hospitalization.      Study Design: This will be a multicenter, randomized controlled clinical trial in patients     with HF and reduced left ventricular ejection fraction (LVEF) who are discharged from     hospital following an episode of acutely decompensated HF. The clinical effectiveness of a     physician-directed patient self-management strategy based on remotely collected physiological     data obtained from home-based and wearable devices will be compared with two control groups     who will receive the home-based remote HF management system without activation or routine     therapy. In the interventional arm, there will be three modes of home-based HF management:     (1) Early discharge mode to optimize volume status; (2) Drug escalation mode to ensure the     utilization of evidence-based medications at the maximum tolerated dose; and (3) Maintenance     mode to ensure medication compliance and early detection of complications such as acutely     decompensated HF and atrial fibrillation. The trial will enroll up to 876 patients with LVEF     <40% who are discharged from hospital after an episode of acutely decompensated HF.     Randomization to the intervention group or control groups will be in a 1:1:1 ratio with     follow-up for 1 year. The primary outcome will be a composite of cardiovascular death and HF     hospitalization within 1 year.      Summary: DAVID-HF will provide essential information about the role of home-based, remote     heart failure monitoring that will incorporate instantaneous physician-directed patient-self     management in the long-term management of HF patients.   "
16257|NCT03072680|"     The aim of this study is to analyze the efficacy of several variations of an already     validated Positive Psychology Intervention (PPI) called Best Possible Self in not flourishing     population. This will be done through a mobile app specially designed for this aim.      Concretely, the design will permit to compare the classic intervention (BPS Future), a new     variation (BPS Past), and a combination of both components (BPS Past+Future).      Participants will be randomly assigned to one of 3 conditions, in which they will practice     the intervention for two weeks:        -  BPS-PAST + BPS FUT condition: Participants will practice BPS Past for one week, and then          they will switch to BPS future for another week.        -  BPS-FUT condition: Participants will practice BPS Future for two weeks.        -  CONTROL condition: Participants will practice DAILY ACTIVITIES for two weeks.   "
16258|NCT03072667|"     This is a compassionate use protocol of an investigational new drug (IND). The overall     purpose of the treatment is to offer alternative treatment to children who developed     parenteral nutrition-associated liver disease (PNALD) and have not responded positively to     currently available medical therapies. PNALD develops in newborns dependent on parenteral     nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and     nutritional fluids; although PN is necessary and life sustaining, it can result in severe     liver disease.   "
16259|NCT03072654|"     The investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and     airflow in patients with benign nodular goiter, employing a prospective observational study.      Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior     to and six months following surgery. Tracheal and thyroid volumes, smallest cross-sectional     area of the trachea (SCAT), tracheal narrowing, tracheal deviation and tracheal encirclement     by the thyroid were evaluated. Through flow-volume curves respiratory function, including     both in- and expiration, was evaluated.   "
16260|NCT03072641|"     The purpose of the study is to determine if probiotic bacteria have a beneficial effect on     the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary     supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄     10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC     700396), and 0.63 g inulin.   "
16261|NCT03072628|"     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine,     nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic     nerve activity   "
16262|NCT03072615|"     The aim of our prospective multicenter study was to investigate the prognostic value of the     acute and long-term changes of liver stiffness in patients receiving a transjugular     intrahepatic portosystemic shunt (TIPS).   "
16266|NCT03072563|"     The cerebro-placental ratio (CPR) is a tool for assessment of fetal wellbeing in the     management of the growth restricted fetus. CPR is the ratio of the fetal middle cerebral     artery pulsatility index (PI) to the umbilical artery PI. In Gestational Diabetes (GDM), the     common finding is of accelerated and asymmetric fetal growth. Pregnancies complicated by GDM     have an increased risk of certain complications such as preeclampsia, intrauterine demise, CS     due to fetal distress. These complications have a well known association with fetal growth     restriction leading to the hypothesis that there exists a subset of diabetic fetuses that     exhibit a growth restriction phenotype despite not being small for gestational age (<10%).The     objective of this study is to examine whether the CPR can identify GDM fetuses that are not     growth restricted but are at increased risk of certain adverse neonatal outcomes. Women with     singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond will be     included. Exclusion criteria are Pre-gestational diabetes, hypertensive disease of pregnancy     at time of recruitment, fetus with a known major anomaly, fetal EFW < 10%(IUGR). Women who     consent to the study will have a blinded Doppler assessment of CPR. Clinicians will be     blinded to these Doppler measurements (unless they are indicated clinically for another     reason (suspected fetal anemia or IUGR development- and the results will be unblinded and     reported to the clinicians). Obstetric and neonatal outcomes will be collected prospctively     via the local BORN database and the patient chart. Local BORN is needed for the registered     outcomes. Newborns will be divided post-hoc into two groups: A) last CPR <10% B) Last CPR >     10%. The primary outcome will be a composite outcome consisting of one or more of the     following: Caesarean section due to suspected fetal distress, 5 minute Apgar <7, Cord     arterial PH < 7, HIE, NICU admission >24 hours.   "
16268|NCT03072537|"     CrescNet is a network of Primary care physicians and pediatricians (n=221) and     endocrinological treatment centers (n=31), established in Leipzig in 1998, whose aim is to     improve the early detection of growth disorders. Secondary to this clinical aim,     epidemiological analyses on secular trends of growth data of children are performed.   "
16269|NCT03072524|"     The aim of this study is to develop and validate a simple prehospital stroke scale, which     would predict the presence of large vessel occlusion (LVO) in patients with acute stroke.     This study prospectively evaluates the predictive value of a new simple pre-hospital scale     (FAST PLUS test) for the presence of large vessel occlusion in anterior intracranial     circulation. The FAST PLUS test consists of two parts: the first is the well-known FAST test,     which is employed in all possible cases of stroke occurrence. This test consists of the     following items: Speech (scored 0-1), Facial palsy (0-1), any failure of Arm motor function     (0-1), and Time (0-1). The second part of FAST PLUS test evaluates only the presence of     severe arm or leg motor deficit (scored 0-1) and unilateral occurrence of its motor function     deficit (scored 0-1).      The FAST PLUS test will be used prospectively at the place of stroke onset by trained medical     emergency technicians. The first objective of study is to evaluate the sensitivity,     specificity, and the positive and negative predictive value of the test which relate to the     presence of occlusion of intracranial artery (intracranial carotid artery, T occlusion and     occlusion of Middle Cerebral artery segment M1 and M2). CT angiography can only diagnose the     LVO.      The second objective of this study is to assess inter-rater variability among stroke     specialists and emergency technicians, concerning the presence of severe motor arm or leg     deficit.      The third objective : After implementation of the FAST TEST to clinical practice, we aim to     achieve the acceleration of transport time in FAST PLUS positive patients via direct     transport to Comprehensive Stroke Center to mechanical thrombectomy.   "
16270|NCT03072511|"     Cigarette smoking is the leading cause of preventable mortality in the United States, yet     less than 10% of smokers making a serious quit attempt remain abstinent from cigarettes 1     year later, and outcomes from gold-standard behavioral interventions leave much room for     improvement. As such, in the context of a Stage-I randomized controlled trial (RCT), this     study will examine (1) treatment characteristics and delivery, treatment integrity, dropout,     and acceptability, (2) smoking outcomes such as lapse, relapse, and abstinence measures, and     (3) changes decision-making that result from a novel intervention informed by behavioral     analysis and social cognition.   "
16271|NCT03072498|"     The purpose of this study is to collect information and bone marrow, blood, saliva, cheek     cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of     treating MDS.   "
16272|NCT03072485|"     This is a phase 1 study in healthy adult volunteers to examine the effects of 3 FDA approved     medications on skin aging when applied in topical form. This is an open label, placebo     controlled study.   "
16273|NCT03072472|"     This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope     bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.   "
16274|NCT03072459|"     A retrospective, multi-center, cohort study with prospective follow-up and comparison to     historical control   "
16275|NCT03072446|"     The purpose of this post-market study is to evaluate UFE agents for the treatment of     symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic     agents.   "
16276|NCT03072433|"     This cluster-randomized controlled trial will evaluate the effectiveness of a four-day     hospital-based intervention program for primary caregivers of children with severe     malnutrition.   "
16277|NCT03072420|"     The objectives was to obtain MRI images of the index finger of the subjects without loading     and with loadings (normal and shear forces from 1 to 4N).   "
16278|NCT03072407|"     This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group,     MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four     once-weekly subcutaneous doses of PB-119 to subjects with T2DM.   "
16279|NCT03072394|"     A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine     2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA)     protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local     anesthesia during transradial coronary angiography.   "
16298|NCT03072134|"     Malignant gliomas have a very poor prognosis with median survival measured in months rather     than years. It is a disease in great need of novel therapeutic approaches. Based on the     encouraging results of our preclinical studies which demonstrate improved efficacy without     added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem     cell line in combination with radiation and chemotherapy is well-suited for evaluation in     newly diganosed malignant gliomas. The standard-of-care allows application of virotherapy as     neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy     without altering the standard treatment.   "
16280|NCT03072381|"     The proposed project will be the first to assess pain- and function-dependent, elbow-specific     quality of life and in-vivo mechanical properties of common extensor tendons post-treatment     with PRP in a Level 1, RCT with subject and assessor blinding. The valuable data gained will     significantly add to the knowledge base of treatment effects of PRP for a chronic     tendinopathy. Positive findings of PRP compared to control (corticosteroid injection) would     suggest future larger scale studies to help establish an optimal protocol for the nonsurgical     management of CLE. Correlating US and shear wave acoustoelastography imaging assessments with     validated clinical outcomes will provide a powerful tool for future outcomes analyses using a     non-invasive imaging modality to monitor tissue healing both morphologically as well as     biomechanically, and may even be used to evaluate injury risk.   "
16281|NCT03072368|"     The goal of our study is to examine eye color at birth and the longitudinal change in eye     color of preterm and full-term newborns.   "
16307|NCT03072017|"     Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and     numerous negative health consequences including depression. Advanced Medical Electronics, in     partnership with researchers are the University of Pennsylvania, propose developing an     innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for     the treatment of insomnia.   "
16282|NCT03072355|"     Introduction: The exercise performed with elastic tools has been appearing in the current     scenario as a clinical tool because it presents advantages such as easy handling, low cost     and safety. However, its use as an assessment tool, specifically for localized muscular     resistance, is reduced and not standardized. In addition, there are no records of the     physiological / neurofunctional effects of tests that use such a tool, since it allows a     differentiated degree of prescription. Objective: To determine the reliability and     reproducibility of a shoulder abduction resistance test in two tools, elastic tube and     isokinetic dynamometer. In addition to analyzing the metabolic profile of both comparative     order and targeting subsequent training prescription. Method: The study will consist of a     sample of 30 participants and will be carried out in 2 stages, 15 participants will perform     step 1 and the other 15 will perform step 2. The difference between the steps is the order of     the tools used to perform the test . Each stage will consist of 5 sessions (Orientation,     Familiarization 1 and 2, Test and Retest). During the test and retest sessions the     physiological response of the test will be analyzed. In order to observe the response, will     be analyzed the lactic anaerobic parameter (lactate concentration), allelic anaerobic     (post-exercise oxygen uptake analysis - EPOC), aerobic parameter (VO2 values) and     electromyographic measurements. Will be used the statistical package SPSS Statistics 22.0,     Pearson's correlation and their respective confidence intervals will indicate the     relationship between the numerical variables and multivariate models will be constructed by     means of linear regression. The significance level of 5% will be adopted.   "
16283|NCT03072342|"     The investigators wish to assess whether intensive periodontal therapy will reduce the burden     of chronic periodontal disease and will cause regression or prevent progression of     atherosclerosis assessed by a surrogate end−point (carotid intima−media thickness) at 24     months compared to control periodontal therapy.   "
16284|NCT03072329|"     The purpose of this study is to check whether the success rate of blind pudendal nerve block     in penile surgery can be optimized by the search for a motor response during     neurostimulation.   "
16285|NCT03072316|"     The investigators intend to undertake a study to investigate the effect of radiotherapy on     deep inferior epigastric perforator flap reconstructions (DIEP). Adjuvant post-mastectomy     radiotherapy (PMRT) is offered to women at high risk of chest wall recurrence. The perceived     detrimental effect of radiotherapy on an immediate breast reconstruction and the one-off     nature of autologous reconstruction leads some surgeons to recommend delayed reconstruction     after mastectomy or to use a temporising implant with a view to planned exchange to     autologous reconstruction after radiotherapy. However, there remains significant uncertainty     in the literature about the impact of radiotherapy on autologous reconstructions. This study     is a mixed methology study using patient reported outcome measures (PROMS), applanation     tonometry (measure of breast compressibility), semi-structured interviews and 3 dimensional     photography analysis to compare the aesthetic and impact on quality of life on the following     groups of patients:      Patient groups:        1. Unilateral skin sparing mastectomy (SSM) with immediate DIEP flap reconstruction and          PMRT (cases)        2. Unilateral SSM with immediate DIEP flap reconstruction and no PMRT (controls)        3. Unilateral simple mastectomy, PMRT, and subsequent delayed DIEP flap reconstruction          (controls)        4. Unilateral SSM with temporizing implant, PMRT and subsequent conversion to DIEP          (controls)   "
16286|NCT03072303|"     The purpose of this study is to learn about pregnancy outcomes in osteogenesis imperfecta     (OI). Patients enrolled in the Brittle Bone Disorders (BBD) Contact Registry (CR) will be     invited via email to participate in this study.   "
16287|NCT03072290|"     To compare the effectiveness of different dose of ultrasound guided steroid injection in     patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in     evlauation   "
16288|NCT03072277|"     DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal     supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months     postpartum and infant follow-up through 12 months. Leveraging the RCT design, DHANI-2 aims to     assess the role of maternal DHA supplementation on infant neurodevelopment and body growth.     It also intends to enhance the mechanistic understanding by the addition of repeated     biochemical measures from mother-child dyads.   "
16299|NCT03072121|"     The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the     treatment of coronary artery disease not amenable to revascularization on the basis of     western medicine therapy.   "
16300|NCT03072108|"     This clinical study evaluates if the oral administration of Bonolive can contribute to the     improvement of functionnality in healthy elderly people with knee discomfort.   "
16301|NCT03072095|"     This randomized controlled pilot study at the Health Annex, Family Practice & Counseling     Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the     feasibility of a mailed FIT approach to CRC screening in a community health setting, and how     patients respond to text messaging and behavioral economic engagement incentives.   "
16302|NCT03072082|"     The purpose of this study is to determine whether Danlou Tablet is effective in the treatment     of coronary artery disease not amenable to revascularization on the basis of western medicine     therapy.   "
16320|NCT03071848|"     This study will evaluate the safety of bevacizumab (Avastin®) combined with standard     chemotherapy in participant with advanced cervical cancer, with special focus on the     incidence of gastrointestinal (GI) and genitourinary (GU) fistulas and GI perforations in the     common practice setting.   "
16303|NCT03072069|"     Anesthesia in the modern age is at least a two-drug process consisting of an opioid and a     sedative hypnotic (e.g., fentanyl and propofol in combination, among others). Therefore, it     is important to understand the interaction pharmacodynamics of these agents as they are used     clinically. A good method for visualizing the pharmacodynamic interaction behavior of drug     combinations is through response surface models. Unlike traditional isobolograms that     represent the concentrations of two agents that combine to produce a single degree of drug     effect, response surface models characterize the complete spectrum of interaction between two     or more agents for all possible levels of concentration and effect. The investigators try to     use the response surface model to evaluate the effect of anesthetic combination of autonomic     system.   "
16305|NCT03072043|"     The main purpose of this study is to determine the safe and recommended dose of APR-246 in     combination with azacitidine as well as to see if this combination of therapy improves     overall survival.   "
16289|NCT03072264|"     The literature suggests that Mindfulness Based Intervention may be effective in the treatment     of anxiety symptoms. The objective of this study is to compare the clinical effectiveness of     a Mindfulness Based Intervention - the Mind in Body Training (MBT) - with a selective     serotonin reuptake inhibitor (Fluoxetine) and an active control group (Quality of Life)     through different biological and clinical outcomes, as well as evaluate some possible     mechanisms of treatment response. Methods: it is a three armed randomized, controlled     clinical trial. Participants with General Anxiety Disorder will be recruited. A community     sample of 192 participants will be randomly allocated to the MBT, Fluoxetine or Quality of     Life Group. Instruments measuring anxiety, worry and meta-worry symptoms, quality of life,     acceptance and self-compassion, mindfulness, rumination and emotion regulation will be     applied. The patients will be submitted to Error Related Negativity (ERN) and Heart Rate     Variability (HRV) measures. The primary outcome is the effectiveness of MBT compared with     Fluoxetine and Quality of Life Group in symptomatic outcomes. The secondary outcome are the     effectiveness os these interventions in emotional regulation process and biological measures     (ERN and HRV), and the evaluation of BMT mechanisms through possible mediation of treatment     response for emotional processes like mindfulness, acceptance and self-compassion, biological     changes (ERN and HRV), and metacognition.   "
16290|NCT03072251|"     To assess concerns and barriers for measuring milk intake of breast fed infants using the     remote food photography method and SmartIntake smartphone application. These data will 1)     provide support for further development of the Infant RFPM and 2) provide important     preliminary data in a National Institutes of Health grant application being developed and     assess the prevalence of exclusive breastfeeding and complementary breastfeeding in the study     population.   "
16291|NCT03072238|"     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of     ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus     abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant     prostate cancer (mCRPC).   "
16292|NCT03072225|"     The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects     Chinese medicine. Designing a RCT trial to prove the effect and safety.   "
16293|NCT03072212|"     We will recruit participants from three tertiary care hospitals in Uganda into an     observational cohort study of people living with HIV/AIDS (PLWHA) and HIV-uninfected persons     matched for gender and residency, presenting with CT-confirmed stroke. We will collect socio     demographic, clinical, laboratory, radiologic, cardiac, and clinical neurologic disease     measures to investigate the effect of HIV-infection on 1) clinical and radiologic     presentation, 2) risk factor profiles; and 3) stroke outcomes (death or disability).   "
16294|NCT03072199|"     RITA-MI aims to develop of a novel therapeutic concept to target the immune response in     patients with acute myocardial infarction (MI) by depleting B-cells with a single injection     of Rituximab which is approved for clinical use in cancer, autoimmune disease and     inflammatory conditions. The goal is to re-purpose the drug, and translate the discovery into     benefit for patients at high risk of cardiovascular events. Rituximab is expected to limit     infarction size and improve the healing process, as complementary to other therapeutic     strategies.      The applicants intend to perform a clinical study in patients with acute myocardial     infarction (MI). The objective is to find the optimal dose (lowest dose with highest     biological efficacy and best safety profile) for peripheral blood B cell depletion during the     first 6 days after injection, and selective molecular signatures associated with improved     heart function through analysis of peripheral blood samples.      The study rationale is to decrease the inflammatory reaction upon tissue necrosis following     heart muscle ischemia.   "
16295|NCT03072173|"     We intend to study, in depth, the quantitative and qualitative properties of nasal     respiration in sleep-disordered breathing and sleep apnea and its relation to (CPAP)     treatment with the final goal of improving patient outcome.      To do this we will temporarily alter patients' nasal airflow during monitored sleep to lower     CPAP air pressure, making CPAP treatment more acceptable to the patient. Additionally we plan     to implement highly advanced computerized modelling in collaboration with the OSASMOD     research consortium at St. Olavs Hospital/NTNU and SINTEF to predict the results of our     alterations and ultimately, to use these predictions to improve both the planning and the     outcomes of nasal surgery.   "
16296|NCT03072160|"     Background:      Medullary thyroid cancer (MTC) is a tumor of the thyroid gland. Surgery is the only current     treatment to cure it. The drug pembrolizumab (MK-3475) is a new type of cancer therapy. It     works by allowing the immune system to detect and kill tumor cells.      Objective:      To test how pembrolizumab affects people with MTC and if it can offer them clinical benefit.      Eligibility:      People ages 18 and older with MTC      Patients who have recurrent or metastatic MTC, for whom surgery is not a curative option      Patients with some imaging evidence of MTC      Patients with minimal symptoms related to MTC      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood, urine, and heart tests        -  CT scan or MRI: They lie in a machine that takes pictures of the body.        -  Bone scan      Participants will be put in a group based on their treatment history:        -  Group 1 if they have had an immune stimulating cancer vaccine        -  Group 2 if they have had no vaccine      Participants will receive the study drug as a 30-minute IV infusion every 3 weeks. Treatment     will continue for up to 2 years as long as they tolerate it and their disease does not get     worse.      Participants will have physical exams and blood tests on the day of each infusion. They will     have CT and bone scans every 3 months.      Participants may save biopsies before treatment and after starting treatment.      Participants will have a final visit 3-4 weeks after stopping treatment. This will include a     physical exam and blood and heart tests.      After this study, participants will can join a long-term follow-up study.   "
16297|NCT03072147|"     The purpose of this study is to evaluate teriparatide (TP) as a chondroregenerative therapy     for human knee osteoarthritis (OA). The central hypothesis to be tested is that TP supports     structural modification of the joint and improves biomarker, functional and patient-reported     measures of knee OA.   "
16321|NCT03071835|"     A comparative study to follow subjects who received stem cell therapies three, five, seven,     and nine years after their follow-on visit. Subjects will be selected from a pool of previous     Interdisciplinary Stem Cell Institute trial participants.   "
16308|NCT03072004|"     We are going to investigate leprosy patients with neuropathies. This problem can lead to     changes in nerve function and lead to disability. We will investigate a protocol with LLLT to     improve pain, inflammation, and to prevent disabilities. We will test two groups, which will     be divided into control and LLLT treated patients. In this groups we will perform     quantitative measurements of the following parameters before and after the protocol     application: electroneuromyography and muscle strength measurements, evaluation of activity     limitation and risk awareness, evaluation of tactile sensitivity and evaluation of     temperatures of hands and feet. Averages for all parameters will be compared before and after     treatment (12 application sessions). We believe that LLLT can become an important alternative     treatment to improve conduction velocity, tactile sensitivity, temperatures of hands and     feet, muscle strength and pain, which will prevent nerve damage and disabilities   "
16309|NCT03071991|"     Postoperative pain and use of narcotic analgesics after laparoscopic bariatric surgeries are     problems that need to be solved in terms of patient comfort. We believe that preincisional     bupivacain injection to the trocar sites will help us for these problems. A study is designed     focused on reduced postoperative pain and reduced use of narcotic analgesics by preincisional     bupivacain injection for laparoscopic bariatric patients.   "
16310|NCT03071978|"     This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing     compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy     (CRT), in Chinese Heart Failure (HF) population. Specifically, the study will assess the     changes of cardiac function of each group through 3-month follow up/ 6-month follow up     compared with original outcomes before aCRT (adaptive Cardiac Resynchronization Therapy)     implantation. Secondly, the study will assess whether parameters of aCRT that were tested in     Western population are relevant to parameters of Chinese HF patients.   "
16311|NCT03071965|"     This study is a prospective, phase 2 extension study of participants previously enrolled in     NTMT-01 and of participants enrolled in NTMT-02. This study is designed to evaluate long term     safety and efficacy of the NT-501 implant in participants previously enrolled in the NTMT-01     and NTMT-02 protocols.   "
16312|NCT03071952|"     The primary objective of this study is to assess the clinical efficacy of AAIR (Atrial-paced     Atrial-sensed Inhibitory Rate-Modulated) pacing treatment for heart failure (HF) patients     with chronotropic incompetence (CI) in terms of exercise tolerance and quality of life.     Specifically, the study will assess the changes in cardiac function associated with changes     of physical exercise intensity and heart rate in AAIR pacing mode compared with AAI pacing     mode.   "
16313|NCT03071939|"     Schizophrenia is a disease of young adults that affects 1% of the general population.     According to numerous studies, it has been estimated that between 50% and 80% of patients     with schizophrenia do not consider to have a mental disorder and are therefore not aware of     their disorders. A poor degree of insight is associated with poor compliance, a higher number     of re-hospitalizations, altered social and relational functioning, and a higher number of     suicides and violent behaviors. This is why insight, which is an essential dimension of     psychopathology, must be evaluated, as it depends to a large extent on the therapeutic     alliance, adherence to treatment, likelihood of relapse and prognosis.   "
16314|NCT03071926|"     Metronomic PLD in Patients with Primary Endocrine Resistant ABC   "
16315|NCT03071913|"     This pilot research trial studies blood brain barrier differences in patients with brain     tumors undergoing surgery. Studying samples of tissue and blood from patients with brain     tumors in the laboratory may help doctors to understand how well drugs get into different     parts of a brain tumor. This may help them to determine which types of drugs may be best for     treating brain tumors.   "
16316|NCT03071900|"     Detection rate and isolation yield of CTC is low in squamous cell carcinoma of head and neck     (SCCHN) with in vitro approaches rely on limited sample volumes. In this study, we applied a     new method, the CellCollector, which could capture CTC in vivo from peripheral blood.   "
16317|NCT03071887|"     The goal of this study is to refine and pilot the Relaxation Response Resiliency (3RP)     intervention for women age 50 and over who are living with HIV, a group especially burdened     by stressors related both to aging and living with chronic disease. The investigators will     adapt the 3RP resiliency intervention to the needs of this population and conduct preliminary     testing of the group intervention via an open pilot study.   "
16318|NCT03071874|"     This research study is studying a chemotherapy as a possible treatment for Meningiomas     (recurrent).      The study intervention involved in this study is:      --AZD2014 (vistusertib)   "
16322|NCT03071822|"     The PIGLETS regimen was devised to replace the conventional SMILE regimen in management of     extranodal NK/T cell lymphoma in our institution. It had been three years since the     introduction of PIGLETS regimen in treatment of NK malignancies. The response rate is     encouraging, with an overall response rate (ORR) of 90% in NK malignancies. Side effects are     generally tolerable. The investigator therefore propose the use of PIGLETS on newly diagnosed     or relapsed/refractory PTCLs.   "
16323|NCT03071809|"     The aim of this study is to employ genomic detection methodologies to measure the relative     amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage     solid tumor who are either commencing, currently undergoing or have completed treatment. This     approach will allow the investigators to develop a quantitative measure of therapy efficacy     via the counting of the relative changes in tumor molecules over the course of treatment.   "
16324|NCT03071796|"     In this study the investigator will evaluate whether a liquid multivitamin supplement     influences blood and vital parameters. Furthermore the investigator will establish the     effects on life quality, mood and perception of stress and will characterize changes on     immune system.   "
16325|NCT03071783|"     The objective of the clinical investigation is to test whether intra-operative traction force     feed back during vacuum extraction leads to a significant decrease in incidence of brain     damage in neonates.      By randomization, half of the vacuum extraction patients will be assigned to delivery using a     new intelligent handle for vacuum extractions, and half will be assigned to conventional     method without traction force measurement.   "
16333|NCT03071679|"     This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the     pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.   "
16326|NCT03071770|"     The purpose of this Phase I, single-dose, open-label trial is to evaluate the     pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and     Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib     (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place     serially through-out the duration of subject participation.   "
16327|NCT03071757|"     The primary purpose of this Phase 1, open-label study is to evaluate the safety,     pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination     with nivolumab in participants with locally advanced or metastatic solid tumors. The study     will consist of 2 parts: ABBV-368 dose escalation and ABBV-368 tumor-specific dose expansion     (non-small cell lung cancer [NSCLC] cohort and head and neck cancer cohort) .   "
16328|NCT03071744|"     Advanced cancer patients often require palliative (pain relieving) radiotherapy to treat     cancer-related symptoms. The delivery of radiation requires patients to lie still on a hard     flat surface, which can result in significant acute (intense) pain and/or breakthrough cancer     pain (sudden sharp or stabbing pain), especially when painful bone metastases are present.     The current care for most cancer patients receiving radiation is to take an oral (by mouth)     opioid medication before the radiation treatment. The pain relieving effects of these     medications can take about one hour and can last for 3 to 6 hours, which does not follow the     time course of when breakthrough cancer pain occurs.      Lazanda is a pain medication delivered via an intranasal route and is already approved by the     U.S. Food and Drug Administration (FDA) for the management of breakthrough cancer pain for     patients who are already receiving opioids and who can tolerate opioids for the treatment of     cancer pain. Lazanda is fast-acting and convenient for patients to take. The purpose of this     study is to assess the change in pain intensity during palliative radiotherapy following     study treatment with Lazanda. This study will also explore the impact of the study treatment     on the efficiency in delivering the radiation therapy   "
16329|NCT03071731|"     This project is aimed to assess the responsiveness of the Glittre ADL-test and the 1-Minute     Sit-to-Stand test (1-Minute STST) to acute bronchodilation in patients with COPD. We also aim     to investigate the physiological and perceptual response to bronchodilation of the Glittre     ADL-test and the 1-minute STST. The specific objectives are 1)To measure the changes in time     for completion of the Glittre ADL-test and the number of standing up during the 1-minute STST     induced by a single dose of nebulized ipratropium bromide/salbutamol sulfate against those     induced by a placebo in patients with moderate to severe COPD and 2)To compare in patients     with moderate to severe COPD the CR (minute ventilation (VE), oxygen uptake (VO2), carbon     dioxide production (VCO2) and heart rate) and symptomatic (dyspnea and leg fatigue     perception) responses during the Glittre ADL-test and the 1-Minute STST following a single     dose of ipratropium bromide/salbutamol sulfate or placebo. We suppose among others that the     Glittre test completion time will be lesser, that the number of repetitions in the 1-Minute     STST will be higher and symptoms intensity will be lesser among patients with COPD receiving     bronchodilators.   "
16330|NCT03071718|"     Mediterranean diet (Med-D) has been recognized as an intangible cultural heritage by UNESCO     and was shown to be beneficial for the treatment of obesity, type-2 diabetes and     cardiovascular diseases. Individuals with the highest adherence to Med-D (classified     according to Sofi et al., 2010) were characterized by increased levels of specific     fibre-degrading bacteria, increased faecal levels of short chain fatty acids, and lower     urinary concentrations of the atherogenic compound TMAO. However, the interplays between     Med-D and microbial populations in the intestine remain unclear. Moreover, a number of     clinical conditions like obesity, T2D, and atherosclerosis are associated with dysbiotic     microbial ecosystems in the gut, i.e., shifts in the structure and function of the     microbiota, but the characteristic features of dysbiotic gut communities and the impact of     diet are not very well defined. The present study will evaluate the impact of Med-D on     cardiometabolic health in human subjects via modification of intestinal microbial communities     and its impact on health outcomes, mainly related to inflammatory, oxidative and hormonal     status, in overweight subjects.   "
16363|NCT03071289|"     Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy.     And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim     of this study is to compare observation with radiation on pelvic lymphocyst of cervical     cancer patients after radical resection, for incidence of adverse events and local recurrence     rate.   "
16382|NCT03071042|"     This study evaluated the tolerance, safety and efficacy of Apatinib plus Docetaxel as the     second-line treatment in locally advanced or metastatic gastric cancer (including     Gastroesophageal junction (GEJ) Adenocarcinoma).   "
33511|NCT02847143|"     The study aims to characterize the cerebral activation modifications related to nasal     oxytocin administration during vizualisation of distress images in population of healthy     people with different attachement styles.   "
16331|NCT03071705|"     Treatment for patients with mutation in the epidermal growth factor receptor (EGFR) with     specific domain tyrosine kinase inhibitors (TKIs) has given place to objective clinical     response, increase in progression-free survival (PFS) compared to cytotoxic chemotherapy.     However, despite clinical success with different TKIs, most patients eventually develop     acquired resistance to these agents after an average period of time of 10 months.      Recently metformin, an oral hypoglycemic agent, has been associated with reduction in the     global risk of incidence and mortality of different types of cancer, by exercising anti-tumor     properties. Its role as a chemo-preventive and adjuvant drug in overcoming acquired     resistance to chemotherapy, target therapy and immunotherapy in NSCLC is still under     discussion.      However, preclinical data support the role as an adjuvant drug in the treatment of NSCLC in     combination with chemotherapy or EGFR-TKIs. This evidence led to examine the effects of     metformin in combination with EGFR-TKIs in a NSCLC cellular line panel, obtaining a different     sensibility to the unique use with EGFR-TKIs. The combination of metformin and TKIs reduced     the colony forming capacity and proliferation, and induced a huge pro-apoptotic effect in     NSCLC cellular lines and resistance in EGFR-TKIs. This suggests that metformin may reduce the     resistance to TKIs. A retrospective study in patients from our institution from 2008 to 2014,     showed significant clinical benefit in patients who used metformin, improving the global     survival. Based on these considerations, we propose a phase II randomized study to assess the     effect and safety of metformin in combination with TKIs as second line therapy in patients     with NSCLC in advanced stages with EGFR mutation.      The main objective of this study is to assess the progression-free survival period in     patients with advanced non-small cell lung cancer in treatment with TKIs and metformin versus     TKI alone.   "
16332|NCT03071692|"     The primary objective of the study is to determine whether pemafibrate administered twice     daily will delay the time to first occurrence of any component of the clinical composite     endpoint of:        -  nonfatal Myocardial Infarction (MI)        -  nonfatal ischemic stroke        -  hospitalization for unstable angina requiring unplanned coronary revascularization; or        -  Cardio Vascular (CV) death.   "
16334|NCT03071666|"     Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient     deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut     function may decrease absorption. Vitamin B12 is crucial for normal cell division and     differentiation, and necessary for the development and myelination of the central nervous     system. Deficiency is also associated with impaired fetal and infant growth. In the proposed     study we will measure the effect of daily oral vitamin B12 supplementation to pregnant women     on neurodevelopment and growth of their children. We also aim to measure the impact of B12     supplementation on several other outcomes.      Study design: Individually randomized double-blind placebo controlled trial in pregnant South     Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1     ratio.      Study participants and site: 600 pregnant women from early pregnancy. Women will be enrolled     as early as possible, but no later than in week 15 of pregnancy.      Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6     months after birth.      Comparator: Placebo, identical to the vitamin B12 supplements.      Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii)     growth in children measured by weight and length at 12 months. Secondary: (i)     neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at     birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month     and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers.      Relevance for programs and public health: The results from this study can suggest new dietary     guidelines for South Asian women that again can lead to improved pregnancy outcomes and     neurodevelopment and cognitive functioning in South Asian children.   "
16335|NCT03071653|"     A randomized controlled trial to test the potential safety and efficacy of LCSD in patients     with heart failure due to non-ischemic and ischemic cardiomyopathy at the University of Cape     Town. Left Cardiac Sympathetic Denervation (LCSD) is a surgical intervention that modulates     the autonomic innervation of the cardiac system. This is important because: a] sympathetic     and parasympathetic tone has a profound effect on the threshold for ventricular     tachyarrhythmias-the main cause of sudden cardiac death in this population; and b] autonomic     dysfunction (which is characterized by an imbalance between sympathetic and parasympathetic     activation), plays an important detrimental role in the pathophysiology and progression of     heart failure.   "
16336|NCT03071640|"     This study is a first part of a larger project aiming at improving the following outcomes in     older cancer patients receiving external beam radiation therapy (EBRT): quality of life,     functioning and need for professional help (dependency). To achieve this, the investigators     will develop and test a geriatric assessment (GA) with management (GAM) intervention     targeting patients at risk of negative outcomes as defined. The problems and needs that older     patients experience before, during and after EBRT are poorly described. Furthermore, although     GA is the recommended approach to assess older cancer patients' vulnerability, very few     studies have investigated its benefit and feasibility in a radiotherapy setting and there is     no universal recipe for how an efficient GAM intervention should be applied in this setting.     Before defining and testing an intervention, the investigators will therefore conduct an     observational study addressing older patients >= 65 years referred for either palliative or     curative EBRT. The main objectives are to identify patients at risk for negative outcomes,     and to test the feasibility of GA in the community service and at a radiotherapy department.   "
16337|NCT03071627|"     The main objective of this study is to compare the interpretation of health news items     reporting results of pre-clinical studies with or without spin (i.e., distortion of research     results). The news items which reported those studies evaluating the treatment effect either     in cell culture studies or animal studies, have high number of spin in the headline and text     and received high online public attention will be selected. Spin will be deleted and will     rewrite the news items without spin. This sample of news items reporting results of     pre-clinical studies with and without spin will be interpreted by French-speaking population.   "
16338|NCT03071614|"     The main objective of this study is to compare the interpretation of health news items     reporting results of pre-clinical studies with or without spin (i.e., distortion of research     results). The news items which reported those studies evaluating the treatment effect either     in cell culture studies or animal studies, have high number of spin in the headline and text     and received high online public attention will be selected. Spin will be deleted and will     rewrite the news items without spin. This sample of news items reporting results of     pre-clinical studies with and without spin will be interpreted by English-speaking     population.   "
16339|NCT03071601|"     The purpose of this study is to determine if topical analgesia using a lidocaine and     prilocaine cream improves pain scores compared to the usual local anesthesia using     subcutaneous 1% lidocaine and adrenalin injected near the laceration.   "
16340|NCT03071588|"     The aim of the study is to assess clinically, radiographically and microbiologically a new     protocol for indirect pulp capping procedures compared to the conventional protocol in     painful teeth. It was postulated that there is no difference between both protocols in terms     clinical, radiographical and microbial outcome measure after one year of follow up in painful     teeth.   "
16379|NCT03071081|"     This study evaluates the safety and tolerability of TOP1288 oral single ascending and     multiple doses in healthy subjects.   "
16341|NCT03071575|"     This is an open-label, randomized, 2-arm clinical trial in healthy infants in Bangladesh. The     primary purpose of the study is to assess the immunogenicity of measles-rubella (MR) vaccine     when delivered at 6 months. In addition, the study will establish the equality of MR vaccine     seroconversion administered at 9 months following administration of an earlier MR vaccine     dose at 6 months of age compared to MR vaccine dose administered at 9 months without previous     MR vaccination. This study will also provide additional data on safety and tolerance of MR     vaccine given at 6 months, and impact of maternal antibodies on immunogenicity of MR vaccine     at 6 months.        -  Primary objectives:             1. To assess immunogenicity of MR vaccine at 6 months of age             2. To assess immunogenicity of MR vaccine at 9 months of age among children without               prior measles and rubella vaccination, compared with MR vaccine immunogenicity               among those who had a prior MR vaccination at 6 months of age        -  Secondary objectives             1. To assess the frequency of adverse reactions following administration of MR vaccine               at 6 months             2. To compare the immunogenicity of the MR vaccine first dose administered at 6 months               vs at 9 months.             3. To assess the proportion of mothers with undetectable, detectable and protective               levels of measles and rubella antibodies             4. To determine the extent of variation in measles antibodies in women of child               bearing age in a population with a long standing measles vaccination program             5. To determine the extent of variation in rubella antibodies in women of child               bearing age in a population where rubella vaccine have been recently introduced             6. To determine if variation in antibody levels in infants at 6 months is               predominately explained by variation in starting antibody levels in the mother in               this population             7. To estimate the half-life of decay of measles and rubella antibodies in infants   "
16364|NCT03071276|"     This study will be done in two parts: Phase I (NCT02212561) has been completed and published.     The goal of the Phase I portion of this study was to find the highest tolerable dose of     selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome     (MDS), when it is combined with fludarabine and cytarabine.      The Phase II portion of the protocol is reflected in this registration.      The goal of the Phase II portion of this protocol is to give the highest dose of selinexor     (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for     children with acute myeloid leukemia (AML). The investigators will examine the effect of this     combination treatment.   "
19683|NCT03027934|"     The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples     obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in     a cross-over design.   "
16342|NCT03071562|"     Approximately 50% of people living with HIV (and as many as 80% over the age of 50) have     difficulties with cognitive functions such as memory and thinking that can have a profound     negative impact on activities of daily living and quality of life. Problems with memory and     thinking are also associated with forgetting to take anti-retroviral drugs and experiencing     challenges to balance, walking and mental health (anxiety and depression). There is     increasing evidence that, in the general population, exercise has positive effects on     cognition, physical functioning and mental health. Despite the recognition of multiple     therapeutic benefits of exercise, little attention has been paid to its possible effects on     cognition in people living with HIV. The purpose of the proposed pilot study is to compare     the effects of a 12-week, randomly assigned, community-based yoga-mindfulness intervention on     cognition, balance, walking, mental health and quality of life in 30 people >45 years of age     living with HIV in the Halifax area. Yoga is of particular interest because it encompasses     not only the physical but also spiritual, emotional, and mental dimensions of life. As such,     it has tremendous potential to help stave off some of the devastating consequences of HIV     infection.   "
16343|NCT03071549|"     Acne patients were included in this randomized controlled trial. Each patient received four     treatment sessions two weeks apart. 20% azelaic acid combined with 20% salicylic acid were     applied to the one side of the face while 25% trichloroacetic acid was applied to the other     side. Evaluation was done by counting number of non-inflammatory and inflammatory lesions     before, after two and after four treatment sessions. The dermoscope was used in evaluating     the degree of improvement of erythema.   "
16344|NCT03071536|"     Furosemide is an old drug that has been used frequently in the postoperative period of kidney     transplantation, aiming to achieve adequate urine output. There is no previous study that     directly evaluate the urine response to standardized dose of furosemide in the postoperative     period. The objective is to measure the urine output after standardized dose of furosemide is     delivered, as a biomarker to predict the graft function in perioperative period.   "
16345|NCT03071523|"     Different augmentation techniques has been proposed to resolve problem of hard and/or soft     tissue ridge defects to enable dental implant placement. Guided bone regeneration GBR     procedure is considered as an acceptable reliable surgical procedure for localized ridge     augmentation. Exposure of the membrane used for the GBR is considered a major disadvantage of     this procedure. In order to avoid such complication, various flap advancement techniques have     been proposed such as Periosteal releasing incision,Double-Flap Incision,Coronally advanced     lingual flap. The study compare between the flap advancement provided by Periosteal releasing     incision,versus,Coronally advanced lingual flap in the treatment of class 1 ridge defect.   "
16346|NCT03071510|"     The objective of the study is to compare Atlas Genetics io® system results with those     obtained from comparator devices.   "
16347|NCT03071497|"     -  In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn,          preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity          and mortality as well as with the need for a blood transfusion.        -  A successful preoperative treatment of IDA via iron supplementation requires a timely          screening of iron deficiency, typically done by analyzing specific blood parameters.          This however of course requires drawing a blood sample which further reduces the          patients' blood volume and is in many cases stated as an inconvenient procedure.        -  Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect          ID.        -  This study aims to evaluate a prototype device detecting ZnPP non-invasively in the          intact oral mucosa of surgical patients.        -  Results from the non-invasive measurement will be compared to reference measurements of          ZnPP from residual blood samples (HPLC analysis) as well as to other parameters          including Hb level and iron profile (MCH [= mean corpuscular hemoglobin], MCV [= mean          corpuscular volume], ferritin, transferrin, transferrin saturation, soluble transferrin          receptor, CRP).   "
16348|NCT03071484|"     Background: Cognitive deficits are a core symptom of schizophrenia even at the early stages     of psychosis. To date, there has been reliable evidence that cognitive deficits are     associated with outcomes in schizophrenia and early treatment could help to reduce the     prominent disabling cognitive symptomatology which most schizophrenia patients still     experience persistently. Outcomes in studies of repetitive transcranial magnetic stimulation     in schizophrenia patients suggest the possibility that application of transcranial     direct-current stimulation (tDCS) with inhibitory stimulation over the left temporo-parietal     cortex and excitatory stimulation over the left dorsolateral prefrontal cortex could affect     positive and negative symptoms, respectively. Positive effects of tDCS have also been     reported on cognitive symptoms. The present study protocol hypothesis is that the development     and utilization of potentially effective neuroenhancement tools such as a non-invasive brain     stimulation technique like tDCS for the treatment and rehabilitation of cognitive impairment     in early stages of Schizophrenia may contribute to the elucidation of the nature of the     complex and dynamic processes in the brain during the early stages of the disease, and may     lead to a better outcome.      Objectives: The aim of the present study protocol is to evaluate the efficacy of tDCS in the     treatment of cognitive symptomatology in the early stages of psychosis.      Methods: Sixty patients in the early stages of psychosis will be randomly allocated to     receive 20 minutes of active 2-mA tDCS or sham stimulation once a day on 10 consecutive     weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the     cathode over the left temporo-parietal cortex. Neuropsychological and psychiatric assessments     will be performed at the time of consent (baseline), at 1 and 3 months following the end of     the intervention (maintenance effect).   "
16349|NCT03071471|"     Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the     vertebrae and discs gradually develop a curvature that is first detected in patients between     11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from     radiographs by the Cobb angle .      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each     vertebra and disc between the superior and inferior end vertebrae . Although a small curve is     well tolerated and does not require treatment, a large curve can progress to the point that     it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac     and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the     initiation of the curve and its subsequent progression. The factors responsible for the     initiation of the curve are unknown, but the subsequent progression of the curve is clearly     associated with the adolescent growth spurt . The primary risk factors for progression     include age at onset and the magnitude of the curve; young patients with large curves are at     the highest risk .      Although numerous treatment methods have been recommended for patients with AIS, the only     accepted treatment includes bracing for skeletally immature patients with curves between 25     and 40 degrees and operative correction with spinal fusion for patients with curves greater     than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing     has caused compliance problems with wearing the brace and many patients only wear the brace     at home . While operative intervention completely corrects the scoliosis or rib hump, it     eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion     potentially leading to disc degeneration and back pain.      Despite satisfactory short-term results of operative instrumentation and fusion, a less     invasive technique preserving more motion with a smaller scar represents a major improvement.     Realizing this goal is contingent on treating curves early, before they progress to an     irreversible deformity, and when there is still enough residual growth and remodeling     potential.      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system     is designed to correct the deformity step by step along a period of time, giving the skeletal     and soft tissues time to accommodate any incremental correction.      The MID-C System inherent benefits are:        -  Only two screws are used        -  Incision size is much smaller        -  Simpler operation with shorter operative time        -  Less complications (attributed to the three points above).        -  Minimal spinal mobility loss.      All the device components are made of materials well accepted in the orthopedic field and are     fully biocompatible (see Investigator Brochure).      The unique concept of the system and the materials used may provide favorable results as     follows: Smaller scare, quicker healing period and better spine mobility over the years.      This study is designed to demonstrate that the MID-C System is safe and effective.   "
16350|NCT03071458|"     The MUTHEC project aims to describe the mutational and transcriptomic landscape of HCC     treated by curative treatments (resection, radio frequency ablation, transplantation) as well     as advanced HCC together with the analysis of circulating tumor DNA.   "
16351|NCT03071445|"     Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the     vertebrae and discs gradually develop a curvature that is first detected in patients between     11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from     radiographs by the Cobb angle .      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each     vertebra and disc between the superior and inferior end vertebrae . Although a small curve is     well tolerated and does not require treatment, a large curve can progress to the point that     it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac     and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the     initiation of the curve and its subsequent progression. The factors responsible for the     initiation of the curve are unknown, but the subsequent progression of the curve is clearly     associated with the adolescent growth spurt . The primary risk factors for progression     include age at onset and the magnitude of the curve; young patients with large curves are at     the highest risk .      Although numerous treatment methods have been recommended for patients with AIS, the only     accepted treatment includes bracing for skeletally immature patients with curves between 25     and 40 degrees and operative correction with spinal fusion for patients with curves greater     than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing     has caused compliance problems with wearing the brace and many patients only wear the brace     at home . While operative intervention completely corrects the scoliosis or rib hump, it     eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion     potentially leading to disc degeneration and back pain.      Despite satisfactory short-term results of operative instrumentation and fusion, a less     invasive technique preserving more motion with a smaller scar represents a major improvement.     Realizing this goal is contingent on treating curves early, before they progress to an     irreversible deformity, and when there is still enough residual growth and remodeling     potential.      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system     is designed to correct the deformity step by step along a period of time, giving the skeletal     and soft tissues time to accommodate any incremental correction.      The MID-C System inherent benefits are:        -  Only two screws are used        -  Incision size is much smaller        -  Simpler operation with shorter operative time        -  Less complications (attributed to the three points above).        -  Minimal spinal mobility loss.      All the device components are made of materials well accepted in the orthopedic field and are     fully biocompatible (see Investigator Brochure).      The unique concept of the system and the materials used may provide favorable results as     follows: Smaller scare, quicker healing period and better spine mobility over the years.      This study is designed to demonstrate that the MID-C System is safe and effective.   "
33796|NCT02843425|"     The goal of this clinical research study is to learn if eating canned, pre-cooked beans can     help improve the levels of healthy bacteria in the digestive system and reduce the effects of     obesity on cancer risk.   "
16365|NCT03071263|"     The purpose of this study is to determine if patiromer treatment in chronic kidney disease     (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will     result in more persistent use of spironolactone through prevention of hyperkalemia and lead     to improved blood pressure control compared with treatment with spironolactone alone     (placebo).   "
16414|NCT03070626|"     Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance     due to surgical stress.      The aim of this study is to investigate whether preoperative oral carbohydrate loading can     contribute to lower incidence of postoperative discomfort and to reduce complications in     elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).   "
16352|NCT03071432|"     Rationale: Complications of chronic hyperglycaemia associated with Diabetes Mellitus type 2     (DM2) include macro- and microvascular angiopathy. Cerebral Autoregulation (CA), the     capability of the brain to maintain constant cerebral blood flow (CBF) despite changes in     blood pressure, is impaired early in DM2 implicating that CBF becomes dependent on blood     pressure. In addition, 20-60% of all patients with DM2 suffers from cardiovascular autonomic     neuropathy (CAN) resulting in more unstable blood pressure regulation. In patients without     DM2 or CAN, induction of anaesthesia results in slightly decreased blood pressure, but     cerebral perfusion is maintained through CA. In contrast, patients with DM2 and CAN may     display greater reductions in blood pressure and cerebral perfusion may become jeopardized     due to impaired CA. This could be an explanation for the increased incidence of stroke in     patients with DM2.      Objective:        1. To study whether peri-operative haemodynamics fluctuate more in patients with DM2 and          CAN.        2. To study whether CAN further worsens cerebral perfusion in addition to impaired CA.      Study design: Prospective, observational cohort trial. Study population: A total of 45     patients, 30 with DM2 and 15 healthy controls scheduled for elective, non-cardiothoracic     surgery under general anesthesia and age 18 years and above will be included in the study.     After inclusion, DM2-patients will be categorized in two groups (both 15 patients): patients     with and patients without CAN. Given the prevalence of 20-60% CAN, we plan to screen at most     100 patients and include 15 patients in each study group.      Intervention (if applicable):        1. PRE-operative: chart review, short physical examination, autonomic function tests to          determine the presence of CAN. These tests are simple physiological tests that can be          performed on a regular ward and involve a Vasalva manoeuvre, 3 minute paced breathing          with a frequency of 6·min-1 and tests for orthostatic hypotension. Also, we test the          sensitivity of the cerebral vasculature to CO2 by measuring during one-minute          hyperventilation and one minute CO2-rebreathing. Continuous blood pressure monitoring          will be obtained using ccNexfin, a non-invasive monitor that comprises a single          inflatable finger cuff. Cerebral perfusion will be assessed non-invasively using          transcranial Doppler attached with a headband to the temporal skin area and          (non-invasive) measurement of cerebral oxygenation using near-infrared spectroscopy          (NIRS).        2. INTRA-operative: we repeat the 3 minute paced breathing test and the CO2-reactivity          test.      Main study parameters/endpoints: Between group difference in haemodynamic parameters and     cerebral perfusion parameters.   "
16353|NCT03071419|"     This pilot study evaluates the feasibility and impact of a father-focused childhood obesity     prevention program on paternal food-related parenting practices, mealtime behaviors and     father/child nutrition and physical activity behaviors. Half of participants (low-income     father and child dyads) will receive an intervention immediately while the other half of     participants will serve as a wait-list control group and receive the intervention at a later     date.   "
16354|NCT03071406|"     The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs     nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy     (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it     will stimulate the body's immune system to work against tumor cells. This study will test an     investigational use of nivolumab.   "
16355|NCT03071393|"     This study will examine if acute intermittent hypoxia (brief episodes of breathing lower     oxygen), which has been shown to enhance plasticity and motor output, can enhance functional     outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess     breathing, sitting, standing and walking functional ability before and after acute     intermittent hypoxia, compared to a sham treatment. This information may be useful in     advancing rehabilitation for people with spinal cord injuries.   "
16356|NCT03071380|"     An open label randomized, single dose, two-way crossover bioequivalence study to determine     the bioequivalence of Rivaroxaban from Repatoxaban 10 mg Tablets (Horus for Pharmaceutical     Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed from: Bayer     Healthcare, Germany)   "
16357|NCT03071367|"     Multiple studies have shown clinical simulation benefits over classical learning method.     Research on simulation of airway management has focused on endotracheal intubation training,     while research on ventilation via facemask is scant. The investigators compared both learning     methods regarding the acquirement of basic skills for airway management by medical students.     Students in the clinical simulation group received a 3-hour training on airway management on     the first day of their 28-day anesthesia rotation, while classical learning did not. On the     last day of rotation, participants were evaluated based on a validated instrument of scores.     Primary outcome was airway management scores. Secondary outcomes were rate of success of     intubation and incidence of complications.   "
16358|NCT03071354|"     The investigators propose to conduct a randomized, control trial of     β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with     acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific     nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily     until day 28 following randomization (even if discharged).The investigators will measure     functional outcomes using standard, validated measures prior and after discharge.   "
16359|NCT03071341|"     AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the     enzyme peripherally and to the brain, when administered intravenously.      This is a long term safety and tolerability study of AGT-181 in patients with MPS I who     completed the previous 26-week study, AGT-181-101. Information on the biological activity of     the investigational drug will also be collected.   "
16360|NCT03071328|"     The purpose of this study is to plan for future clinical trials in patients with Metastatic     Castration-resistant Prostate Cancer (mCRPC). Diluted iodinated contrast will be injected     intra-tumorally under CT fluoroscopy guidance into bone, lymph node, and liver metastases in     subjects with mCRPC, and pre and post-injection CT images will be obtained to determine the     injection parameters needed for optimal distribution throughout metastases of a given size. A     biopsy of the metastatic site will also be obtained to validate the expression of CD155 in     prostate cancer.   "
16361|NCT03071315|"     The study compared the effectiveness and cost-effectiveness of two dominant heroin dependence     treatment approaches: center-based compulsory rehabilitation (CCT) and community-based     voluntary methadone treatment (MMT) in Hai Phong City, Vietnam. The design was a combined     retrospective and prospective, non-randomized cohort over three years (with data at five     time-points). The study was conducted between 2012 and 2015, involving 208 CCT participants     and 384 MMT participants with heroin dependence.   "
16362|NCT03071302|"     Evaluation of tomographic (Pentacam) parameters and genetic parameters of Visual System     Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases     (TIMP3) genes of keratoconus patients diagnosed by clinical exam and topographic pattern.     Basically we are screening patients that don't have keratoconus that those have keratoconus.     The pentacam index of corneal curvature, thinnest point, corneal high order aberrations,     posterior and anterior elevation, corneal densitometry, corneal volume were investigated. To     analyze the genes, we took corneal epithelium samples of patients submitted to cross linking     compared to (PRK) Photo Refractive Keratectomy ones. Also will be evaluated the genes of     peripheral blood.   "
16366|NCT03071250|"     The care for patients receiving total hip and knee arthroplasty at UAMS has followed a     structured care pathway since July 2015. This system of perioperative care has focused on     preoperative assessment of medical co-morbidities and risks to postoperative functional     recovery, anesthetic care focused on PONV prevention and optimizing immediate postoperative     functional ability, and aggressive postoperative physical therapy.      This is an observational study to look at the outcomes of this program at UAMS. Areas of     focus will be hospital length of stay, postoperative narcotic consumption, VAS scores,     incidence of PONV, and 30-day readmission rates, and health literacy rates.   "
16367|NCT03071237|"     Infrapyloric artery(IPA) is of great importance for gastric cancer patients. According to     previous study, the origin of IPA varies greatly among different studies. This trial aims to     tell the distribution of IPA origin in Chinese patients.   "
16368|NCT03071224|"     The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a     tau targeted radiopharmaceutical.   "
16369|NCT03071211|"     This is a randomized controlled trial comparing plug-unplug catheter management, continuous     drainage catheter systems and patients that do not get discharged with catheters after     inpatient pelvic reconstructive surgery.   "
16370|NCT03071198|"     Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0     middle and lower rectal cancer   "
16371|NCT03071185|"     The use of free fibular flaps and anterolateral thigh (ALT) flaps for repairing the     oromandibular defects is well established, whereas few attentions were focused on     postoperative analgesia for the donor area. The purpose of this trial is to determine if     using lower limb nerve blocks in patients undergoing free flap-based oromandibular     reconstruction can significantly decrease use of pain medications and to evaluate the safety     of lower limb nerve blocks.      Patients with oromandibular defects who were scheduled for elective reconstructive surgery     using free fibular or ALT flaps, were divided into two groups in a randomized, single-blind     fashion. In Group PCA, only intravenous patient controlled analgesia (PCA) was used     postoperatively. In Group PCA+B, both intravenous PCA and lower limb blocks were used.     Post-operative narcotic usage, post-operative pain score, post-operative anti-emetic usage,     vital signs, onset and duration of sensory and motor block, the presence of adverse effects     such as nausea and vomiting were recorded.   "
16372|NCT03071172|"     The aim of this study was to evaluate the efficacy and safety of domestic recombinant human     follicle stimulating hormone (rhFSH) stimulating ovarian to promote follicular development     before assisted reproductive technology, which was non-inferiority than that of the imported     rhFSH.   "
16373|NCT03071159|"     Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and     the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in     90 children by questionnaires and routine measurement of HbA1c values.   "
16374|NCT03071146|"     The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent     System. It is intended for use in patients who suffer from peripheral artery disease (PAD).     PAD is generally associated with blocked arteries of the legs. The superficial femoral artery     (SFA) and popliteal artery are common locations for this problem to develop. The patient may     experience pain or discomfort in the leg that occurs when walking or have other complications     associated with wound healing. The purpose of this study is to collect information to assess     the deliverability, clinical utility, safety and effectiveness of the Bard® LifeStent® 5F     Vascular Stent System.   "
16375|NCT03071133|"     An observational, postmarketing commitment following the marketing authorization for DCV Trio     therapy in Japan   "
16376|NCT03071120|"     The goal is to pilot a parent-mediated intervention for feeding challenges in children with     autism building on our recent research and current successful models already being used. A     parent-mediated intervention would primarily occur in the home environment, working with the     parent to establish goals and implement the intervention based on their child's specific     needs.   "
16377|NCT03071107|"     The proposed investigation for this study aims to; 1) understand the prevalence and outcomes     associated with frailty among haemodialysis patients; 2) ascertain the best frailty     assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the     feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and     psychological intervention to improve frailty status among haemodialysis patients.      Work package 1: Firstly, there is a need to understand the prevalence and spectrum of frailty     in a UK haemodialysis cohort and what impact frailty has for haemodialysis patients. To     investigate this, the investigators will approach every patient on haemodialysis within the     local catchment of haemodialysis units and, after informed consent, clinically phenotype     their frailty status (pre- and post-haemodialysis for calculation of variability). The     frailty phenotyping will encompass a number of frailty assessments (including the Edmonton     Frail Scale, Clinical Frailty Scale from Rookwood score and Fried Frailty scale) to identify     the ideal frailty assessment tool. All patients in this observational cohort study will be     prospectively monitored for clinical/biochemical outcomes using an informatics-based approach     for up to 60 months.      Work package 2: Building upon the work conducted in work package 1, work package 2 will aim     to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a     feasibility study exploring a multi-disciplinary intervention to improve frailty status.     Eligible patients, after informed consent, will be randomised into active or passive     intervention. The active intervention will involve a dietitian and physiotherapist who have     been trained and accredited with cognitive behavior intervention, utilising established     behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention     targeting multiple components of frailty.      The FITNESS project will therefore answer some important unanswered questions regarding     frailty among the haemodialysis population and help in the design of a large     multi-disciplinary intervention study if deemed feasible.   "
16378|NCT03071094|"     This is a study to Evaluate the Safety and Efficacy of the Combination of the Oncolytic     Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line     Treatment of Advanced Hepatocellular Carcinoma (HCC).   "
16383|NCT03071029|"     A six-month RCT conducted within 36 health centres throughout urban and rural Nepal. The     purpose of the RCT is to test the effectiveness of a peer comparison intervention at     increasing uptake of long-acting reversible contraceptives (LARCs) as a percentage of PAFP     uptake among clients who receive a safe abortion at a Marie Stopes International Nepal. The     total sample size will be ~12,000 safe abortion clients. The primary outcome of interest is     LARCs among safe abortion clients at Marie Stopes Centres in Nepal. The secondary outcome is     to evaluate the impact of behaviorally designed intervention on the service providers'     engagement in discussing measures to increase PAFP LARC uptake among women.   "
16384|NCT03071016|"     This study is a non-interventional, multicentre, prospective, observational study to be     conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per     site. The study will be initiated after obtaining written approval of Independent Ethics     Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the     patient.   "
16385|NCT03071003|"     Sensorion are the study sponsor and the objective of this study is to investigate the safety     and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose     administration and to confirm that, there is no interconversion of the (R) enantiomer to the     (S) enantiomer.      The study only involves the one drug, referred to as SENS-401.The key objective is to assess     the safety of SENS 401 after multiple doses in healthy subjects.      The population who are eligible to take part in the study are healthy male and female,     non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at     Simbec.      Participation in the trial will last for about 3 weeks (from first screening to final end of     study visit).   "
16386|NCT03070990|"     The objective of this study is to assess the safety, tolerability and pharmacokinetics of     enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with     locally advanced or metastatic urothelial carcinoma. This study will also assess the     immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor     activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese     subjects with locally advanced or metastatic urothelial carcinoma.   "
16387|NCT03070977|"     Research question and basic idea:      Interprofessional collaboration is a skill that many health professionals need to develop.     Interprofessional training offers a way to improve collaboration and patient care. The     increasing number of psychiatric patients with complex needs, requires mental healthcare     providers to enhance their skills. It necessitates that healthcare professionals collaborate     effectively; nevertheless, many have not been trained in an interprofessional environment.     Health professionals lack sufficient knowledge of other professional roles and competences to     engage in teamwork. Interprofessional study units have been designed to create an optimal     learning environment for healthcare students. These study units provide a new environment for     learning, where students can learn from each other and develop competence in     interprofessional collaboration. This collaboration gives students from several health     professions an opportunity to achieve a greater understanding of the overall picture of the     patient´s life. The limited data available suggest interprofessional collaboration     interventions can improve health-care processes and outcomes; however, better designed     studies are needed.      Objective: Therefore, we will investigate whether placement at a psychiatric study unit     compared with placement at a standard psychiatric ward improves students´ interprofessional     skills.   "
16388|NCT03070964|"     Prospective, multicenter, phase II clinical trial to determine the efficacy of plitidepsin in     patients with relapsed/refractory (R/R) angioimmunoblastic Tcell lymphoma (AITL).This is an     international, multicenter study (with approximately 17 investigative sites).   "
16389|NCT03070951|"     The primary objective of this study is to demonstrate the superior efficacy versus placebo of     OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual     bleeding associated with uterine fibroids in premenopausal women.   "
16392|NCT03070912|"     ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are     increasingly used. However bleeding complications occurring in up to 50% of patients are     poorly understood and worsen the overall results. The aim is to investigate the occurence of     bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous.     The investigators also want to assess the relation of bleeding with von Willebrand Factor     defects.   "
16393|NCT03070899|"     The primary objective of this study is to demonstrate the superior efficacy versus placebo of     OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual     bleeding associated with uterine fibroids in premenopausal women.   "
16394|NCT03070886|"     This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation     therapy to see how well it works compared with antiandrogen therapy and radiation therapy     alone in treating patients with prostate cancer that has been removed by surgery. Androgen     can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen     made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink     tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or     without docetaxel after surgery may kill any remaining tumor cells.   "
16395|NCT03070873|"     The investigators designed a prospective study in this article to evaluate the efficacy, the     life quality and the complications of two different meshes of type I (one is Perigee/Apogee,     the other is named Gynecare prolift) versus traditional surgery, and also studied the     influence of some surgical procedures on the prognosis.   "
16396|NCT03070860|"     The investigators hypothesize is that in PXE patients, low grade chronic inflammation could     preceed the molecular and the clinical calcification process.   "
16398|NCT03070834|"     The risk of venous thromboembolism (VTE) is very high in trauma patients, secondary to tissue     injury, venous status from immobilization, and thrombophilia. As such, early initiation of     VTE prophylaxis is essential in this population. The competing risks of life threatening     hemorrhage and VTE need to be considered very carefully. Potential approaches to VTE     prophylaxis include pharmacologic means, and mechanical devices. For patients unable to     receive pharmacologic VTE prophylaxis, retrievable inferior vena cava filters (rIVCFs) may be     placed until low molecular weight heparin (LMWH) can be initiated, as per guidelines such as     Eastern Association for the Surgery of Trauma      The investigators propose a feasibility study to determine whether or not our center can     insert rIVCFs in at-risk trauma patients expeditiously enough to cause a meaningful reduction     in the time they are left unprotected to PE.   "
16413|NCT03070639|"     The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention     on parents' knowledge, beliefs, intentions, skills and practices related to creating and     maintaining a safe sleep environment for their infants during the first four months of life;     2) describe the characteristics of physician anticipatory guidance about safe sleep and     identify physician, patient and parent characteristics associated with coverage of the topic     at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies     (BHB)'s safe sleep campaign messages and services among our study participants.   "
16415|NCT03070613|"     This is a feasibility study investigating the use of a fluorescently conjugated lectin to     identify colorectal dysplasia and cancer during colonoscopy and surgery.   "
16399|NCT03070821|"     The project aims to investigate in patients of Alzheimer's disease in a prodromal state     (early state of the disease) compared to healthy subjects whether neurofeedback training with     functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary     modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive     ability, as well as functional and structural measures of the brain.      Over the course of the study subjects will learn a real-world footpath. During neurofeedback     training subjects are then asked to recall this footpath while simultaneously trying to     modulate their own brain activation based on feedback. Feedback is given about the     parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial     memory, which is known to be affected early by Alzheimer's disease pathology.      Before and after the training cognitive ability is assessed using neuropsychological tests     mainly measuring numerous domains of memory.      The investigators hypothesise that the training leads to an improvement of the trained     cognitive domain, but also induces changes in brain structure and function.   "
16400|NCT03070808|"     The rate of obesity and bariatric surgery is rising steadily. Though Bariatric Surgery     Influences on aspects such as endocrin analysis, finance, etc are well tested, quantitative     and quality voice impacts have not been evaluated. The aim of the study is to recruit 50     patients who underwent bariatric surgery and compare voice quality in each of these patients     before and after surgery.   "
16401|NCT03070795|"     study compares the outcomes of feeding mothers early (4 hours ) after cesarean section     compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function     and maternal satisfaction with the feeding schedule.   "
16403|NCT03070769|"     The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of     OSA patients and to investigate any correlation between these markers with clinical and     polysomnographic (PSG) parameters.      Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities     were excluded from the study. Included patients were grouped according to apnea-hypopnea     index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group.     Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen,     erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between     groups.   "
16404|NCT03070756|"     This study implements an extended (post marked) examination of the efficacy of a proactive     auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of     patients with predominantly obstructive sleep apnea. The auto-CPAP algorithm examined in this     study is implemented in the medical devices prisma20A and prismaLAB (Löwenstein Medical     Technology).   "
16405|NCT03070743|"     Posterior compression distraction reduction technique （PCDR） in the treatment of Basilar     invagination associated with atlantoaxial dislocation   "
16406|NCT03070730|"     The purpose of this study is to test the hypothesis that patients with non-neuropathic POTS     will have different responsiveness than patients with neuropathic POTS to direct alpha-1     adrenoreceptor agonist therapy (droxidopa) and to non-selective beta-adrenoreceptor     antagonist therapy (atenolol).      The specific goal of this protocol is to investigate the effect of atenolol and droxidopa on     cardiovascular autonomic functions such as cardiovagal control, sympathetic nerve activity,     and sympathetic vascular transduction, systemic hemodynamic response to orthostatic stress     and on the quality of life in neuropathic and non-neuropathic patients with postural     tachycardia syndrome (POTS).      Standardized tests are used to assess cardiovagal control function, sympathetic nerve     activity, sympathetic vascular transduction, systemic hemodynamic response to head-up tilt     test and standardized questionnaires to assess the quality of life in patients with POTS.      The cardiovagal, sympathetic and hemodynamic measurements are performed after and during drug     administration. To control the effect of medications placebo is used on separate testing     visits. The order of drugs and placebo is randomized.   "
16407|NCT03070717|"     This research project intends to observe patients with high myopia who show pathological     retinal changes, in order to evaluate more data on the risk factors for developing mCNV     within this research project population in Germany.   "
16408|NCT03070704|"     This study is conducted in Asia. The aim of this study is to evaluate long term safety and     efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.   "
16409|NCT03070691|"     This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus     vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients     will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete     clinical clearance and complete histological clearance in BCCs.   "
16410|NCT03070678|"     Primary Objective:      To assess the effect of multiple dose mefenamic acid on the pharmacokinetics (PK) of     sotagliflozin and its metabolite in healthy male and female subjects.      Secondary Objectives:        -  To assess total 24 hour urinary glucose excretion (UGE) after 400 mg sotagliflozin alone          and in combination with mefenamic acid in healthy male and female subjects.        -  To assess the safety and tolerability of sotagliflozin alone and in combination with          mefenamic acid in healthy male and female subjects.   "
33819|NCT02843126|"     The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK)     immunotherapy to recurrent breast cancer.   "
16411|NCT03070665|"     Endoscopic submucosal dissection(ESD) is a prominent minimally invasive operation technique     for treating early gastrointestinal tumor. But promoting ESD is uneasy because of its     complications such as postoperative bleeding, perforation and so on. So if we decrease the     rate of postoperative bleeding, ESD might be better popularized. Some study indicated that     hypertension was the independent risk factor of postoperative bleeding. Endoscopic center of     Fudan University Zhongshan Hospital is a rich experienced medical unit in doing ESD operation     in China. Referring to our experience, if we can use some special methods to find the     potential bleeding spot which is not obvious during ESD operation and we coagulate it     precisely, then we may control the risk of postoperative bleeding.      Based on the above hypothesis, our team designed this study to examine whether increasing     blood pressure during gastric ESD could help to control the risk of postoperative bleeding.   "
16412|NCT03070652|"     Key research question This project addresses the following key research question: What are     the short and long term effects on child and family outcomes of a universal intervention     delivered by a Health Visitor addressing the newborn´s behavior in a shared observation with     the parents (NBO)? The aim is to enhance the parent's sensitivity to their infants' unique     capacities and thereby create an early parental understanding for the individual infant's     strengths as well as its needs.      Hypothesis concerning main outcomes      Universal Health Visiting with facilitation of the early relationship building introduced by     the NBO to an intervention group of new families will- when compared to a control group of     new families who receive health visitor support as usual:        -  Improve sensitive responsive parenting to the infant's behavior, needs for feeding and          comfort, and rise understanding of parental influence on the infants' self-regulatory          capacities        -  Increase parental confidence and reduce experiences of stress and symptoms of depression          among new mothers and fathers        -  Improve the infant's self-regulatory capacities regarding sleep, crying, feeding and          engaging in social interactions, being more cooperative        -  Enhance the sensitive early parent/infant relationship        -  Improve exclusive breastfeeding duration and delay introduction to solid food      Method The project is formed as a community based randomized trial. The complexity in     community based intervention research is the existence of two target groups, in this case: 1)     the primary study population of new parents that receive the supportive intervention and 2)     the secondary study population of Health Visitors that deliver the supportive intervention.     The complication of catching the effects in a universal approach will be addressed through a     variety of outcomes that capture both the aspect and the development of the infant, the     mother and the father and the interactions.      Recruitment and randomization Four medium-sized municipalities will join in the trial. To     avoid side-effects the districts of the Health Visitors in the participating municipalities     will be regarded as clusters. Because of differences in size and social status of the     inhabitants in the districts alias the clusters, the clusters will be stratified before they     are randomized to intervention or comparison group. The randomization procedure will be     computer based and conducted by an independent person not involved in the study.      Study population The primary study population is formed by new families, mothers and fathers     and their infant/s. Substantiated in that we are operating with a community based universal     intervention with no side effects and we seek to measure the effect in a natural population     we will have no exclusion criteria except parents or infants affiliated to special treatment     elsewhere.      In the study population of new parents there will be subgroups: First time parents will     represent around 40 %, around 6 % will have given premature birth, 2% twin birth, 10-14% of     the mothers and 7-8% of the fathers will suffer from birth depression in the postnatal     period, and 7-20% will have a cultural background other than Danish depending on geographical     area.      A random sample of 100 mothers who have received the intervention will be drawn for video     recording in the middle of the project period after specified characteristic criteria with     regard to first-time-, depressed- and given premature birth. Afterwards a matched group of     100 mothers will be selected in the comparison group.      Data and data-collection Data will be collected from two sources: (1) self-reported data from     the new parents collected via questionnaire; (2) observational data from video recordings,     Infant CARE-Index. Questionnaire data will be delivered and collected though an internet     based system. Participating mothers and fathers will receive separate questionnaires at 1-2     weeks postpartum (baseline data), 3 months postpartum, 9 months follow-up, 18 months     follow-up. Videos are recorded at 3 months post-partum (corrected age for premature infants)     with 3 minutes of unstructured time together; (Infant CARE Index). All data will be linked     via the Danish Personal Register (CPR) identifier. To minimize bias introduced by data     collection, data will be collected in the same way and with the same timing in the     intervention and comparison groups.      Data Analysis Intention to treat analysis will be used to detect the effect of the community     based intervention where motivation and participation may vary in both the primary and     secondary study population. Supplemental analysis will be performed to identify an     intervention effect for subgroups and marginal groups of parents according to parity, preterm     delivery, and depression symptoms.   "
19779|NCT03026660|"     The purpose of this study is to determine the effects of Moringa Oleifera on the structure     and function of bone in post-menopausal women ingesting 1000 mg of Moringa Oleifera daily for     12 weeks.   "
16416|NCT03070600|"     In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have     HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at     risk receive PrEP while no women not at HIV risk receive PrEP (Figure 4). With mandatory PrEP     given to all women (similar to the approaches used for malaria prophylaxis), all women at     risk would be covered but many women not at risk receive unnecessary PrEP. Our premise is     that a targeted PrEP model may be closer to perfect coverage than a universal     offer/self-select model. Implementing targeted PrEP through strategies that include     facilitation of partner testing with self-tests could add HIV prevention benefit by     increasing partner HIV diagnosis and treatment similar to the initiation of PrEP among     pregnant women. By implementing these strategies and measuring uptake, process, and HIV     incidence, we can inform the best health systems model for PrEP delivery in pregnancy.   "
16417|NCT03070587|"     The purpose of this study is to develop and test a mindfulness and loving-kindness based     intervention, Positive Affect Training (PAT), to enhance positive affect such as compassion,     love, and gratitude and reduce symptoms of social anxiety disorder (SAD). PAT involves a     combination of practicing mindfulness meditation and loving kindness meditation in groups.     Although PAT has been shown to be effective for dysthymic disorder, one area that remains     unclear is whether the PAT protocol for SAD can address the social anxiety symptoms in     Japanese adults with SAD. The goal of the research is to test the initial feasibility and     efficacy in increasing positive affect and decreasing negative affect in individuals     recruited from the general community who are social anxious. If PAT is also effective for     Japanese SAD patients, it could be more cost-effective and noninvasive option to address     social anxiety disorder.   "
16418|NCT03070574|"     Multicenter, multinational, randomized, 3-arm, double-blind, phase II clinical study with     2400mg Mesalamine, 1200mg Mesalamine or placebo for prevention of neoplasia in Lynch Syndrome     patients for 2 years.   "
16419|NCT03070561|"     Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract     in healthy adults and children   "
16420|NCT03070548|"     This study will evaluate the mass balance of talazoparib after a single dose of talazoparib.   "
16421|NCT03070535|"     This study involves the collection of cognitive and biomarker responses to HIGH and LOW meals     in healthy older adults with and without the APOE E4 genotype. Subjects will eat the meal     after an overnight fast, followed by cognitive testing, spinal fluid and blood collection.     The HIGH meal will be a meal high in saturated fat and high glycemic index foods vs. LOW meal     which will be low in saturated fat and low glycemic index foods.   "
16422|NCT03070522|"     This will be a 3 year randomized, double blind, placebo controlled trial of 7 days of oral     prednisone in cystic fibrosis (CF) patients receiving intravenous (IV) antibiotic treatment     for a pulmonary exacerbation at the Hospital for Sick Children, St Michael's Hospital, St     Paul's Hospital, British Columbia Children's Hospital, Hotel Dieu Hospital and Ste Justine     Hospital, Canada. The intervention will be oral prednisone 2 mg/kg/day (max 60 mg) divided     twice daily for 7 days as an adjunctive therapy for pulmonary exacerbations in CF patients     who have not recovered their baseline forced expiratory volume in 1 second (FEV1) after 7     days of IV antibiotic treatment. The primary outcome will be the proportion of subjects who     achieve >90% of their baseline FEV1 % predicted at day 14 of IV antibiotic treatment for a     pulmonary exacerbation in each treatment arm.   "
16423|NCT03070509|"     This study is being conducted to evaluate how the body absorbs and processes the medication     lisdexamfetamine (Vyvanse®). Subjects who are 9-15 months post gastric bypass surgery will be     invited to participate. Non-surgical controls will also be enrolled based on a matching     criteria to post gastric bypass subjects. Participants will be asked to complete one 12-hour     study day and complete one 24-hour post dosing blood draw.   "
16438|NCT03070314|"     In this bioavailability trial should be shown that the one of the main active constituent in     alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid     isobutylamide (short: tetraen) is bioavailable in children of different age groups after     intake of 5 Echinaforce junior tablets.   "
16439|NCT03070301|"     The purpose of this study is to test any good and bad effects of the combination of LEE011     with everolimus on the participant and the cancer.   "
16424|NCT03070496|"     Ischemic heart disease is the leading cause of mortality with 7.2 million of death in     industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion     of a coronary artery is the most brutal form and the more severe ischemic myocardial disease.     Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed     remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from     myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult     to assess precisely. The management of the patient depends on these factors, and justifies an     active search on these topics, including the mechanisms of the deleterious ventricular     remodeling, myocardial inflammation, reperfusion injury which determines in particular the     evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can     be very valuable by their clinical, laboratory and imaging well documented. They are the     source of new hypotheses for research or interventions as well as the quality of care     assessment tool.      The main objective of this project is to identify new markers: biological and imaging,     treatment response and prognosis after acute myocardial infarction.      Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed     by biological samples and by imaging data that can be used in the following areas:        -  Descriptive epidemiology of myocardial infarction and myocardial reperfusion        -  Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of          treatment in real life, costs        -  Assessment of the long-term effect of the treatment on the occurrence of heart failure          and sudden death        -  Quality of life and personal consequences, family, professional and social myocardial          infarction        -  Research of new diagnostic and prognostic biomarkers        -  Research projects (e.g. risk of developing kidney failure or stroke in patients with          myocardial infarction compared to the general population).   "
16442|NCT03070262|"     Caffeic acid can target inhibit GASC1 expression and GASC1 is confirmed to be a new oncogene     in several cancers including esophageal cancer. This study aims to investigate the efficiency     and safety of coffeic acid in chinese advanced esophageal squamous cell cancer (ESCC).   "
16443|NCT03070249|"     This study will assess compassion fatigue among healthcare providers in a single emergency     department (ED) using the Professional Quality of Life (ProQoL) scale.   "
16444|NCT03070236|"     This research study is evaluating how patients feel physically and emotionally after a prior     breast biopsy for specific breast conditions (including atypical lesions such as atypical     ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ     (LCIS), and/or ductal carcinoma in situ (DCIS))   "
19780|NCT03026647|"     Retrospective chart review evaluating different suture types on surgical outcomes for     cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures     are used.   "
16425|NCT03070483|"     Adequate levels of vitamin D are essential for bone health at all ages but low levels of     vitamin D may also negatively impact other aspects of health such as blood pressure. The     investigators have previously shown that adults with African ancestry living near the equator     have much higher levels of vitamin D and higher levels of blood pressure compared to adults     with African ancestry living in the Chicago area. Multiple clinical trials have examined     vitamin D supplementation for reducing blood pressure levels but very few studies have     focused on adults with African ancestry and low vitamin D levels. In addition, most previous     clinical trials have not addressed calcium intake. While vitamin D may modulate blood     pressure via its actions on activation of the renin angiotensin aldosterone system, it is     also possible that vitamin D mediates blood pressure via its effects on gastrointestinal     calcium absorption. This pilot study is a one arm study, which will assess the safety and     feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels     with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium     daily for 3 months. Participants will be recruited from the Maywood Illinois and surrounding     areas with flyers and brochures. The investigators will also contact previous participants of     the Modeling the Epidemiologic Study/Vitamin D Ancillary Study by phone and letters. At     baseline, all participants will have blood pressure measured and will provide a fasting serum     specimen and a 24-hour urine collection. Calcium, parathyroid hormone level vitamin D will be     measured in serum specimens and 24-hour urine calcium excretion will be measured. Repeat     visits will be completed at 6 and 12 weeks of follow-up to again measure resting blood     pressure and serum calcium and vitamin D levels. The overall goal is to collect pilot data to     help design a larger trial of vitamin D and calcium supplementation for lowering blood     pressure in young adults with African ancestry.   "
16427|NCT03070457|"     Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay)     after scheduled sleeve gastrectomy.   "
16428|NCT03070444|"     The purpose of this trial is to evaluate and compare stability after orthodontic treatment     with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the     mandibular arch and longitudinally follow these patients over time up to 5 years. The     patients' perceptions of the two methods are also evaluated with questionnaires during the     follow-up period.      A further aim of this study is to analyze the relationship between diagnosis, treatment     outcome, treatment time, age at start of treatment and stability with an Essix retainer in     the maxilla.      The null hypotheses are:        -  that there is no difference in retention capacity between Essix retainer and          cuspid-to-cuspid retainer        -  that there is no difference in patients' perception between Essix retainer and          cuspid-to-cuspid retainer        -  that there is no difference in retention capacity for Essix retainer in the maxilla          concerning diagnosis before treatment, treatment outcomes, treatment time and age at          start of treatment   "
16429|NCT03070431|"     The major goal of this clinical study is to investigate to which extent high-precision     radiotherapy (RT) with modern techniques can prevent progression or recurrence of motor     deficits (weakness) of the legs following RT. In addition, it will be evaluated to which     extent RT can lead to improvement of motor function, ambulatory status, sensory function and     sphincter dysfunction, to pain relief and to improvement in quality of life, side effects and     overall survival. For this purpose 44 patients who will receive modern high-precision RT     treatment for the metastases on their vertebral bodies will be included into this phase 2     study. The results of the high-precision RT with a treatment of 5x5 Gray (Gy) in 1 week will     be compared to data of a historical control group. The data set of the historical control     group consists of more than 500 patients who received conventional RT with 5x4 Gy. The data     collected in 1 week treatment will be compared. It is intended to show superiority regarding     the local progression-free survival (LPFS) for the high-precision RT when compared with the     conventional RT.   "
16430|NCT03070418|"     Femoral cervical fractures fixation with DHS plate throw 3 cm incision and minimum surgical     trauma.   "
16431|NCT03070405|"     The main purpose of this study is to evaluate whether PAS will change the PK parameters of     tenofovir.   "
16433|NCT03070379|"     At recent, the number of patients who underwent sedated esophagogastroduodenoscopy has been     on the increase. For such patients, whether topical pharyngeal anesthesia is needed remains     to be controversial. European Society of Gastrointestinal Endoscopy, European Society of     Gastroenterology and Endoscopy Nurses and Associates, and the European Society of     Anaesthesiology Guideline for non-anesthesiologist administration of propofol for GI     endoscopy have not made any recommendation, because the role of pharyngeal anesthesia during     propofol sedation for upper digestive endoscopy has not been assessed. Our study aimed at     investigating whether topical lidocaine pharyngeal anesthesia could benefit patients who     underwent esophagogastroduodenoscopy under propofol sedation.   "
16434|NCT03070366|"     The aim of this study is to evaluate the rate of living patients at 1 year with a quality of     life criteria (no decrease) and reduced toxicities. This criteria will be compared in both     groups., A cost effectiveness study is scheduled also.   "
16435|NCT03070353|"     A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with     AKI   "
16440|NCT03070288|"     The aim of this study was to evaluate the color values of the nasal mucosa, which is easily     assessable by a direct, non-invasive, objective photographic measurement, for the purpose of     presenting a diagnostic objective parameter of allergic rhinitis (AR).      All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and     all endoscopic photographs of the septum and both inferior turbinates were taken. Adobe     Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue     (RGB) color components in endoscopic photographs of the nasal mucosa on the septum and     inferior turbinates.   "
16441|NCT03070275|"     Systemically healthy volunteers with no active periodontal disease are recruited from     referrals to the Dept. of Preventive Dentistry, Periodontology and Biology of Implants,     Aristotle Univ of Thessaloniki for implant therapy. After signing a consent form,     participants will be randomized into two treatment groups. Group-A (NA=10) will receive     crestal placement of implants following a two-stage protocol in combination with a biocomplex     comprising autologous alveolar bone marrow mesenchymal stem cells free of animal derived     reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with     autologous fibrin glue. In Group-B (NB=10) implants are placed on the alveolar crest     following a two-stage protocol and the manufacturer's guidelines. Intra-surgical clinical and     radiographic assessments are performed at the time of implant placement (T0) and at the     two-stage surgery (T1). Changes in mucosa thickness, width of keratinized tissues, marginal     bone and bone thickness at the surgical site will be determined at T0-T1. Groups will be     further divided into two subgroups based on mucosal thickness of the surgical site at T0     [thin mucosa (≤2.5mm) for Groups-AI/-BI; thick mucosa (>2.5mm) for Groups-AII/-BII]. A linear     mixed model for repeated measures will be used for data analyses to determine changes in the     dimensions of the peri-implant soft and hard tissues, around two stage-implants placed either     conventionally, or in combination with the biocomplex.   "
16445|NCT03070223|"     Aging with HIV may be related to an earlier development of frailty (weakness) or disability,     including difficulties in tests of strength or walking speed. Few treatments have been shown     to prevent or slow these impairments in people with or without HIV. Some studies have     suggested that the class of drugs called statins (for example, pitavastatin) might be helpful     in slowing frailty or disability. This might happen by decreasing fat within the muscle or by     decreasing inflammation markers (substances in the blood that determine how the body reacts     to infection or irritation) in the blood. Other studies have shown that statins increase the     risk of muscle aches and pains. This substudy is being done to determine the impact of the     drug pitavastatin on muscle.   "
16446|NCT03070210|"     AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided     celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block     (EUS-CPB).      METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the     efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.   "
16447|NCT03070197|"     Approximately 400 Congenital heart disease patients will participate in the research study     which will include one or more research visits for neurodevelopmental testing, brain MRI, and     collection of medical history including previously collected genetic sequencing results. The     investigators will explore the association between genetic variants, neurodevelopmental     deficits, and brain MRI endophenotype. Analyses will compare groups with and without     deleterious de novo mutations.   "
16448|NCT03070184|"     The purpose of the study is to understand the origins of differential response to     beta-blockers in African-Americans and may provide insight regarding racial differences in     cardiovascular risk.   "
16449|NCT03070171|"     The primary objective of this trial is to establish the bioequivalence of tablet formulation     of dabigatran etexilate compared to commercial capsule formulation following oral     administration under fasted condition.      The secondary objective is the evaluation and comparison of several pharmacokinetic     parameters between the treatments.   "
16450|NCT03070158|"     This experimental study will determine the effectiveness of nursing intervention the     attachment promotion to increase the affective bonds between mothers and their premature     infants. The assignment of the mothers to the control group will receive usual care, the     mothers will be assigned to intervention group will receive the intervention.   "
16451|NCT03070145|"     This research study is evaluating the impact and feasibility of a 12-week brisk walking and     moderate strength training exercise intervention including a virtual component in men who are     initiating androgen deprivation therapy (ADT) for prostate cancer   "
16452|NCT03070132|"     The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain     experienced by participants with trigeminal neuralgia (TN). Secondary objectives of this     study are to investigate the safety and tolerability of BIIB074 in participants with TN and     to evaluate the population pharmacokinetics (PK) of BIIB074.   "
16453|NCT03070119|"     The primary objective of the study is to evaluate the long-term safety and tolerability of     BIIB067 in participants with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1     Mutation (SOD1-ALS). The secondary objective is to evaluate the pharmacokinetic (PK) profile     of BIIB067 in participants with SOD1-ALS.   "
16465|NCT03069963|"     Primary Objective:      Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of     Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult     subjects.      Secondary Objective:      Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in     healthy adult subjects.   "
16454|NCT03070106|"     A Functional Medicine (FM) approach to diabetes care focuses on identifying and treating the     etiologies for imbalances in the core physiological systems.(1) If underlying triggers and     imbalances can be identified, the FM approach to addressing root causes(1) can be utilized     through the use of specialized testing to treat and potentially reverse diabetes. If the FM     approach is successful, the impact on diabetes disease burden as well as diabetes-associated     health care costs could be significant. This project will assess the clinical as well as cost     effectiveness of a FM approach to diabetes care compared to a usual care approach for     patients with diabetes on insulin for 5 years or less.   "
16455|NCT03070093|"     The purpose of this study is to provide expanded access to ASP2215 for subjects with     FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission     (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery     [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to     comparable or alternative therapy.   "
16456|NCT03070080|"     Fluid administration during and after surgery is an essential part of postoperative care to     maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are     associated with dehydration from preoperative fasting, bowel preparation, and intra- and     postoperative fluid and electrolyte loss. So, perioperative fluid management has been a topic     of much debate over years and has intensified especially over the past several years.   "
16457|NCT03070067|"     A clinical decision support rule/tool for classification of TIA/mimic that will enable rapid     detection of ACVS in hyper-acute settings is being developed. Also under development is a     multi-protein test using mass spectrometry (MS). This test will provide TIA results within an     hour or two for a fraction of the price of neuroimaging. With guidance provided by this test     at their disposal, physicians can inform patients whether they can go home safely or whether     they need further testing. The right patients will receive the right treatment, reduce     unwarranted imaging risks and costs, and reduce the burden of stroke. The Heart and Stroke     Foundation will work to ensure that physicians, allied healthcare providers, the public and     other stakeholders are aware of the outcomes and clinical impacts of this project.      Further, work is being done to establish the mechanisms to develop a strong phenotype for TIA     that includes medical imaging (MRI), cardiac monitoring, cognitive assessments, and     surveillance of health outcomes for extended periods of time.   "
16549|NCT03068871|"     participants will be randomized into one of three groups: 3-session CET intervention,     3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2     hours and 10 participants will be assigned to each group. There will be two cohorts, with 30     participants in each cohort. The Waiting List group will receive the CET intervention after     the groups have completed theirs.   "
16458|NCT03070054|"     The investigator's are conducting a randomized, blinded study to determine if the     extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25%     bupivacaine-epinephrine can improve the postoperative pain management of hip arthroscopy     patients. Participants will be randomly assigned to the LIA group or non-LIA group prior to     surgery. Participants, anesthesiologists and PACU nurses will be blinded to group assignment,     however the surgeon administering the LIA will be unblinded.   "
16459|NCT03070041|"     The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding     counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital,     Finland. The baseline measurement will be conducted before the implementation of BFHI in 2017     and second measurement will be conducted in 2019 after the certification process. Both staff     members and breastfeeding mothers will be recruited in the study. The main outcomes are the     duration of breastfeeding and breastfeeding attitudes.   "
16460|NCT03070028|"     Patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol     and platelet rich plasma). Sinus healing time, patient satisfaction, complications and     recurrence rates will be compared.   "
16461|NCT03070015|"     The primary purpose of this study (Part A) is to assess changes in body weight and body     circumference parameters that are achievable after 4 weeks on the Nutrisystem program     compared to a self-directed diet (i.e. Dietary Approaches to Stop Hypertension or DASH). In     Part B, subjects on the Nutrisystem program will be given the option to continue the program     for another 8 weeks.   "
16462|NCT03070002|"     The purpose of this study is to look at the amount of cancer cells in the blood of     participants who are being treated with denosumab. The other purpose is to look at how long     it takes for cancer to get worse when participants are being treated with denosumab.     Circulating tumor cells (CTCs) in the blood of patients with metastatic breast cancer (MBC)     have been associated with shorter survival than when CTCs are absent, especially in patients     whose cancer has spread to their bones. In this study, we want it see if denosumab (the study     drug) will decrease the number of CTCs measured in patients with MBC and cancer that has     spread to their bones. We also plan to get blood from participants to study other research     markers of interest.   "
16463|NCT03069989|"     GSK3008348 is being developed as a treatment for IPF. A first-time-in-human study showed that     single nebulized doses of 1−3000 micrograms (mcg) GSK3008348 in healthy volunteers were well     tolerated, with pharmacokinetic (PK) exposures within the defined limits set in the protocol.     The proposed study is a 2-cohort study of single doses, intended to evaluate the safety,     tolerability and PK of the drug in participants with IPF not currently treated with     pirfenidone or nintedanib, and to obtain preliminary information on target engagement. Cohort     1 will be a 2-period, randomized, double-blind, placebo-controlled group with at least 7 days     washout between doses, and follow-up period of up to 7-14 days. Cohort 2 is optional. It will     be designed to further explore safety and to provide additional information on the target     engagement profile of GSK3008348. The total duration of the study will be up to 62 days.   "
16464|NCT03069976|"     Based upon the possible implication of microbiota and abnormal microbial metabolites such as     altered bile acids, in the pathogenesis of PSC, emerging data suggests that oral antibiotics,     such as vancomycin and metronidazole, may have therapeutic effects in this overlap syndrome     or PSC.      The goal of our study is to evaluate role of antibiotics and microflora in children with     AIH/PSC overlap syndrome or with PSC alone. The investigators hope to learn what effects oral     antibiotics has on the bacteria present in stool, and hope to learn to characterize human     intestinal microbial communities, in children suffering from overlap syndrome or PSC.      The hypothesis of the investigators is that overlap syndrome and PSC develop due to altered     microflora and the resulting abnormal bile acids pool. The outcome of overlap syndrome or PSC     could be affected by presence or absence of RCUH. Antibiotics to correct the microflora may     result in disease/cholangiopathy remission.   "
16468|NCT03069924|"     This research is a randomized smoking cessation trial conducted within and specifically     personalized for lung cancer screening patients presenting to a lung screening clinic. Novel     tobacco treatments for this population are critically needed, given the growing population of     lung screening patients, which will grow dramatically now that lung screening is an approved     CMS benefit. In the proposed study, we will test a gain-framed messaging intervention     specifically designed for lung screening patients (vs. unframed messaging), as well as     evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be     translational (in that it can be transferable from our controlled efficacy study to other     lung screening programs).   "
16469|NCT03069911|"     This study evaluates the efficacy of onabotulinumtoxinA (BOTOX®) in the treatment of     depression associated with Idiopathic Parkinson Disease in adults. As a Randomized Controlled     Trial, half of the participants will receive onabotulinumtoxinA injections and half will     receive a placebo saline solution.   "
16470|NCT03069898|"     With an emphasis on 12 3-hour group workshops, the TRUE Dads fatherhood intervention program     focuses on establishing or strengthening three of men's key roles in the family: 1) their     role as providers, through fostering employment and economic self-sufficiency, 2) their role     as fathers, in building and maintaining positive engagement with their children, and 3) their     role in having and keeping a positive relationship with their co-parenting partner (wife,     intimate partner, or other co-parent). The study is a randomized clinical trial that compares     participants in a program track with participants a study track (no treatment control group)     over a one-year period.   "
16490|NCT03069638|"     The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine     sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared     with dinitrous oxide (N2O) which has already been proven safe and effective sedation method     during painful procedures in pediatric patients.      In earlier studies the median VAS during intra-articular corticosteroid injections with     patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with     intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.   "
16551|NCT03068845|"     The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting     balloon compared to conventional balloon in balloon-assisted maturation of non-maturing     arteriovenous fistula in adult renal failure patients.   "
16471|NCT03069885|"     Due to the Danish breast cancer-screening programme and the increased use of genetic     counselling, Danish women are being diagnosed with breast cancer, or a high lifetime risk of     developing breast cancer, at a younger age than previously. An increasing proportion of these     women pursue an immediate breast reconstruction, where the breast is removed and     reconstructed in a single surgical procedure.      As some of these women will need to undergo adjuvant cancer therapy after their breast     surgery, fast recovery is essential in order for the adjuvant therapy not to be delayed. With     the development of new surgical techniques, the complication rate to the immediate breast     reconstructions has improved. However, wound-healing issues remain one of the most common     complications to the surgery with the possibility of delaying the adjuvant therapy and     diminish the aesthetic result.      Incisional negative pressure wound therapy (iNPWT), is a new approach for surgical site     closure. Recently, iNPWT has shown promising results in lowering post-operative     complications, including wound-healing issues, in other surgical settings. However, iNPWT has     still not been studied in an immediate breast reconstructive setting.      The current randomized controlled clinical study will investigate if an iNPWT system, is able     to provide women seeking an immediate breast reconstruction with faster healing and superior     aesthetic results compared to the conventional post-operative wound dressings used today. The     investigators plan to include 60 women, randomized in a 1:1 ratio between iNPWT or     conventional wound dressing. The primary outcome measure is the time until removal of the     surgical drains, which corresponds to the healing progression. Secondarily, complications to     the surgery, assessment of the scar (measured using the Patient and Observer Scar Assessment     Scale) and patient reported satisfaction with the reconstruction (assessed using the BREAST-Q     questionnaire) will be performed. Included patients are examined pre-operatively, and at the     routine controls at four weeks and four months post operatively.      The results from the current study will elucidate if iNPWT aids wound healing after immediate     breast reconstruction, which would lead to fewer patients experiencing delays before their     adjuvant therapy. Furthermore, the results from the aesthetic satisfaction will elucidate if     iNPWT provides the patients with a better self-reported aesthetic result.   "
16472|NCT03069872|"     Background      Ovarian cancer (OC) is a disease with a poor prognosis due to diagnosis at late stage.     Early-stage OC presents with non-specific and vague symptoms and therefore OC usually is not     detected until reaching an advanced stage. From 2008, Danish general practitioners (GPs)     could urgently refer patients suspected of having OC to standardized cancer patient pathways     (CPPs). The CPP is designed for women presenting specific signs and alarm symptoms, and is     supposed to shorten the pathway from suspicion to treatment.      Hypothesis      Direct access to fast transvaginal ultrasound (TVU) through general practice is feasible in     earlier diagnosis of OC.      Aim      The aim of this study is to assess the implementation and clinical implications of direct     referral access to fast TVU through general practice.      Materials and methods      The study is a feasibility study and GPs from in Central Denmark Region are offered direct     access to fast TVU for women aged 40 years or more who present symptoms that could origin     from OC, but which are not classified as alarm symptoms. The GPs will receive education about     updated knowledge on OC symptoms and the use of the guideline for earlier diagnosis of OC in     general practice. The study period is 1 year.      Perspectives      There is a great need to test rational strategies for diagnosing OC at an earlier stage in     order to improve survival. For women who do not fulfil access criteria for the CPP, and for     whom the main prospect for earlier diagnosis is improved identification of symptomatic OC,     this study may provide important new knowledge of how to facilitate the diagnostics of OC in     the future and reduce time to diagnosis and improve survival.   "
16473|NCT03069859|"     Postpartum hemorrhage (PPH) occurs in up to one in ten deliveries worldwide and is the     leading cause of maternal morbidity and mortality. In developing countries 30% of women     develop PPH because access to a number of treatments is not readily available. Interestingly,     the rate of PPH and consequently of maternal morbidity has increased significantly even in     developed nations, such as Canada, over the past decades. This rate is also increasing     amongst parturients in Ontario. Unfortunately, few effective preventative treatments exist.      Antifibrinolytic drugs are routinely used to reduce bleeding and the requirement for blood     transfusions in a wide range of hemorrhagic conditions. The most commonly used     antifibrinolytic drug is tranexamic acid (TXA). TXA is safe, affordable, with very few side     effects. The World Health Organization recommended that TXA be used to reduce blood loss in     several conditions, including in patients with established PPH refractory to conventional     therapy.However, little is known about the prophylactic use of TXA to prevent PPH.   "
16474|NCT03069846|"     The primary objective is to collect emission spectra of normal tissue, pigmented normal     lesion, benign lesion, SCC, BCC and melanoma to construct the database and validate the     classifying algorithm.   "
16475|NCT03069833|"     An NBI-based diagnosis requires training and experience. We are developing a system of     computerized image recognition, which can detect possible NBI features of polyps, and provide     a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic     accuracy.   "
16476|NCT03069820|"     The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced     liver injury. However, patients don't always experience same chemotherapy-induced liver     injury for the same drugs. Therefore, the investigators designed the present study to clarify     risk factors associated with the development of severe hepatotoxicity after therapy with     docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).   "
25061|NCT02957656|"     The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9     pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9     pandemic inactivated influenza vaccine (H7N9 pIIV).   "
16478|NCT03069794|"     Many studies are in favour of the importance of the rachis on the postural balance of the     body.It is possible to study the upright posture by determining the center of pressure using     a platform of strength.The spinal surgery have two objectives ,mechanic and neurologic .By     deformation correction and stabilizing vertebral stages via arthrodesis, it seems to     hypothesize that surgery can modify postural balance.      This study aim to evaluate spinal surgery effect on posture using that plaftorm .   "
16489|NCT03069651|"     Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing     recurrent chest infections (pulmonary exacerbations). People with CF experiencing pulmonary     exacerbation often require a 14day course of intravenous antibiotics and this treatment can     either be delivered in hospital or in the community. Patients admitted to hospital are seen     regularly by members of the CF multidisciplinary team (MDT), including doctors, nurses,     dieticians and physiotherapists. This allows patients' progress to be closely monitored and     also gives patients the opportunity to discuss any concerns or questions. In contrast,     patients receiving IV antibiotics in the community are only seen by the MDT at the beginning     and end of their 14 day course of IV antibiotics. Although CF nurses often visit patients on     12 occasions during the course of treatment, patients are not routinely reassessed by the     rest of the MDT. There is therefore less opportunity for the MDT to adjust patients'     treatment and for patients to communicate with the MDT.      We therefore aim to study whether patients receiving IV antibiotics in the community benefit     from monitoring their own oxygen saturations and lung function, as well as taking part in     twice-weekly videoconferences with the MDT ('virtual care'). We expect that this will enable     the MDT to to assess patients' progress more closely and allow patients to communicate with     the MDT more easily. We will assess whether this improves patients' experience of their care     and whether this translates into improvements in health and economic outcomes.      One hundred subjects will be recruited over a 12month period, with 50 subjects allocated to     'virtual care' and 50 subjects allocated to 'routine care'. Subjects receiving 'routine care'     will receive usual clinical care.      The research team are well placed to perform the study because we are part of a large CF     centre with an excellent record in clinical research.   "
16479|NCT03069781|"     The maintenance of skeletal muscle mass and function is critical for healthy aging. Muscle     loss with disuse, termed muscle disuse muscle atrophy, leads to impaired functional capacity,     the onset of insulin resistance, as well as a heightened risk for morbidity and mortality.     With advancing age there is a chronic wasting of muscle. This is especially true in women,     where rapid rates of decline in muscle mass and greater anabolic resistance are experienced     around the time of menopause, despite higher protein synthesis rates. As women have a longer     life expectancy, they are particularly venerable to age-related frailty and morbidity.      Skeletal muscle protein turnover serves to maintain the optimal function of proteins and also     provides plasticity of the tissue during altered demands such as during increased loading or     unloading of the muscle. Reduced periods of physical activity also have a similar, albeit     milder, impact on skeletal muscle and most, people will likely experience multiple bouts of     skeletal muscle disuse during their lifetime from which some, particularly older adult women,     will fail to fully recover. Thus, muscle disuse atrophy is a significant and continuing     problem as reclamation of lost muscle mass, strength/function, and potentially metabolic     health (particularly insulin-induced glucose disposal), following disuse is oftentimes     incomplete and may be further exacerbated after menopause.      Previous evidence has demonstrated that in the loss of muscle mass is less pronounced in     post-menopausal women when receiving hormone replacement therapy. Skeletal muscle has     estrogen-β-receptors on the cell membrane, in the cytoplasm and on the nuclear membrane, and     therefore a direct mechanistic link between low estrogen levels and a decrease MPS.     Interestingly, despite higher rates of protein synthesis, older women still lose muscle mass     with advancing age. It has been suggested that the negative muscle protein balance is due to     an enhanced rate of MPB. Insulin is a potent inhibitor of MPB and estrogen has been shown to     enhance insulin sensitivity in skeletal muscle. However, to our knowledge, no study has     examined the efficacy of estrogen supplementation to attenuate the losses of skeletal muscle     mass and function during a period of disuse. The findings of this investigation may yield     critical data for those who wish to combat skeletal muscle disuse atrophy, particularly after     menopause.   "
16480|NCT03069768|"     The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and     preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for     Medication Adherence of Rx Pill), a smartphone application (app) for improving medication     adherence among substance users. The investigators will compare 2 groups of cigarette smokers     undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the     mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart     pillbox that will a record a date and time-stamped medication event whenever pill box is     opened and closed, and thus allow for primary measurement of medication adherence) and b) a     control group using the MEMS Cap and mobile web-based surveys on their smartphone.   "
16481|NCT03069755|"     This study aims to estimate the perioperative mortality rate in adult trauma patients     undergoing acute surgery as well as the association between type of acute surgery and     perioperative mortality in university hospitals in urban India.   "
16482|NCT03069742|"     The purpose of this randomized controlled trial (RCT) is to evaluate a decision support     website (RealRisks) designed to inform patients about breast cancer prevention options. It is     coupled with a physician-centered (BNAV) decision support website as part of clinical     workflow in the primary care setting. The investigators hypothesize that improving accuracy     of breast cancer risk perception and understanding of the risks and benefits of breast cancer     risk lowering drugs, also known as chemoprevention, will increase the uptake of     chemoprevention in the primary care setting.   "
16483|NCT03069729|"     The goal of this research is to develop better tools for diagnosing illness of the feet and     legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in     the refinement of a system designed to detect signs of diabetic peripheral neuropathy (DPN).     The team of investigators will also look at diabetic eye disease and how it might relate to     diabetic foot disease.   "
16484|NCT03069716|"     This study proposes the use of a mobile health intervention (utilizing a smart phone app) to     encourage increased exercise in PAH patients. The study will be a randomized trial to examine     feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application     intervention to improve step counts and increase participants activity level as compared to     no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone     application provides encouragement notifications to half the subjects while the other half do     not receive encouragements.   "
16485|NCT03069703|"     The study hypothesis is that a reinforced pneumococcal combined vaccine strategy in     patients with ANCRA-associated vasculitides treated with rituximab will induce a better     immune response than the current standard regimen, with an acceptable safety profile.      This study therefore aims at evaluating the immunogenicity and safety of two reinforced     innovative pneumococcal vaccine regimen [a double or a quadruple dose of 13-valent     anti-pneumococcal conjugate vaccine (PCV13) followed by one dose of 23-valent unconjugated     vaccine (PPV23) at month 5], compared to the standard regimen (one dose of PCV13 followed by     one dose of PPV23 at month 5), in patients with ANCA-associated vasculitides receiving     rituximab therapy.   "
16486|NCT03069690|"     This study will evaluate the impact of different combinations of intervention as a function     of gestational weight gain in pregnant woman. Participants will be randomized at two points     during the study. Participants will first be randomized at enrollment to receive study     intervention during pregnancy or treatment as usual. Participants will also be randomized     just before delivery to receive intervention postpartum or treatment as usual.   "
16487|NCT03069677|"     The purpose of this study is to determine if there are differences in anxiety scores, heart     rate, blood pressure, and oxygen status when using sedation medication versus music while     undergoing a peripheral nerve block before your surgery.   "
16488|NCT03069664|"     Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and     decreased quality of life. The patients also often need pancreatic enzyme supplements. In     this prospective study the aim is to see whether patients undergoing palliative pancreatic     duct drainage will experience less chronic abdominal pain and a higher quality of life than     patients with the same diagnosis without the procedure. The study also investigates whether     the nutritional state of the patients with palliative stents remains better than in the     control group.   "
16757|NCT03066206|"     The goal of this clinical research study is to learn if poziotinib can help to control     EGFR-positive non-small cell lung cancer (NSCLC) that is locally advanced or metastatic (has     spread). EGFR-positive NSCLC means that there is a mutation (a type of genetic change) on the     EGFR gene.      The safety of poziotinib will also be studied.   "
16545|NCT03068923|"     'The TOP Study' is a prospective cohort study whose main objective is to develop better     prognostic biomarkers and identify children at risk of adverse thrombotic outcomes very early     in the course after an initial venous thromboembolic events (VTE). The study will compare     biomarkers in children that develop poor VTE outcomes (such as recurrence, postthrombotic     syndrome and post PE impairment ) after an initial VTE with those that do not develop such     outcomes.   "
16491|NCT03069625|"     Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of     CF patients regular assessment.      Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to     assess physical capacities. However, simple field tests are emerging. These tests are easier     to perform especially in a population of CF children and adolescents.      The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates     with maximal oxygen consumption during CPET.      The investigators hypothesized that this test also correlates with 6-Minute Walking distance     (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and     health-related quality of life.   "
16492|NCT03069612|"     Cannabis use during adolescence represents a significant risk factor for the development of     psychosis including schizophrenia. Moreover, cannabis is the most commonly used drug among     patients with an existing psychotic disorder. An estimated 25% of patients with psychosis     reportedly meet the criteria of a cannabis use disorder particularly among younger patients     experiencing their first episode. Cannabis use significantly exacerbates symptomatology     resulting in an increased duration of the first hospitalization visit, number of hospital     readmissions, and overall reduced functional outcome. Discovering novel strategies to treat     the underlying pathophysiology of cannabis dependence early in the disorder may translate     into improved functional outcome. Working memory deficits have been shown to predict relapse     in the first-year of psychosis and is modulated with cannabis use. Repetitive transcranial     magnetic stimulation (rTMS) targeted to the dorsolateral prefrontal cortex (DLPFC) has shown     tremendous promise for the treatment of both tobacco dependence and working memory impairment     in patients with psychosis possibly through the modulation of gamma (30-50 Hz) oscillations.     The proposed study will therefore evaluate the effect of rTMS on abstinence, working memory     performance, and gamma oscillations through a randomized, double-blind, placebo-controlled     28-day longitudinal abstinence study design in patients with early psychosis. It will further     explore if baseline performance and gamma oscillations predict abstinence in response to     rTMS. It is hypothesized that active compared to sham rTMS will improve abstinence rates and     improve working memory performance through the modulation of gamma oscillations.   "
16493|NCT03069599|"     The aim of this project is to describe the differential immunologic responses of patients who     undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor,     and surgical resection of the primary tumor only. The primary hypothesis is that IRE induces     a long and sustained activation of the cell-mediated immune system, which is distinct from     the immune response after surgical resection only. The primary endpoint of this study is the     comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally     within a group after the intervention and over time between the three groups. CD4+/CD8+ ratio     will be measured preoperatively and at postoperative days 1, 7, 42, and 180. As a secondary     outcome, additional measurements will be taken to more specifically characterize the immune     response based on peripheral blood samples. Flow cytometry will be used to quantify cell     subsets (CD3+, CD62L+, NK cells, dendritic cells, Th1/Th2 ratio, and Foxp3+ Tregs), and ELISA     will be used to measure cytokine levels (IL-1, IL-2, IL-4, IL-6, IL-10, TNFalpha, IFN-gamma,     VEGF, TGF-beta1, TGF-beta2, sIL-2R, and HSP70), at the same time-points as for the primary     outcome. Each group of patients as described above will consist of 10 consecutive pancreatic     cancer patients. Patients aged 18 or older with resectable, borderline resectable, or locally     advanced pancreatic cancer will be included. Patients with locally advanced disease will     undergo 3 months of preoperative chemotherapy with monitoring to exclude metastatic disease.     Main exclusion criteria are cardiac conduction abnormalities and signs of distant metastasis.   "
16494|NCT03069586|"     The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to     a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain.     Therefore the investigators will conduct a prospective randomized controlled, single blind     trial.   "
16495|NCT03069573|"     The purpose of this study is to find out some potential biomarkers for the Eosinophilic     Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and     assessment of samples collected during the diagnostic process   "
16496|NCT03069560|"     Assessment of the feasibility of a monitoring device by SMS in which messages are sent by the     caregiver after a suicidal act.   "
16554|NCT03068806|"     This is a research study designed to examine how the psychiatric illness called schizophrenia     affects brain function and thinking abilities such as attention and memory during simple     computer-based tasks, and how measures of brain function are related to performance. We do     this by looking at brain activity using electroencephalography (EEG) and magnetic resonance     imaging (MRI). We compare participants' results to the activity in their brain as well as     clinical measures and questionnaires also completed during this study.   "
16497|NCT03069547|"     Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young     adults. PFP is characterised by significant retropatellar and/or peripatellar pain and     impairment of function and quality of daily life. Exercise therapy is unequivocally     recommended as a core component of the management of PFP. Different exercise types (e.g.     quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been     investigated, with knee and hip strengthening exercises as the most common and recommended     types. These exercises approaches produce similar small to moderate effects on pain and     physical function. However, the PFP population is very heterogeneous and     one-size-fits-all-approaches presumably are sub-optimal because the heterogeneity is     ignored. The heterogeneity probably explains the overall limited beneficial effects of     exercise, and the lack of differences in direct comparisons of different exercise types. In     that sense, it is not unlikely that certain patient characteristics may predict outcome     success of either a hip training program or a training program that focus on the quadriceps     but this remains to be shown.      This study has two aims:        1. To assess the comparative effectiveness of two different exercise programs (Quadricep          Exercise [QE] vs. Hip Exercise [HE]) on self-reported pain and function in individuals          with PFP.        2. To explore candidate patient characteristics that predict differential responses to the          two exercise programs (QE vs HE) on self-reported pain and physical function in          individuals with PFP.      According to the study aims we pursue the following hypothesis:      - QE and HE have equivalent efficacy on self-reported pain after 12 weeks of treatment in     patients with PFP.      The second study aim is to explore possible candidate patient characteristics that may     associate with differential outcomes. As this is exploratory, the pursuit of this aim is     hypothesis-free.   "
16546|NCT03068910|"     This study will address a hypothesis that, in late pubertal girls with hyperandrogenemia,     androgens antagonize progesterone's ability to suppress waking LH pulse frequency. All     participants will receive 4 doses of progesterone; half of participants will be pretreated     with androgen receptor blockade (spironolactone, 50 mg twice daily), while the other half     will be pretreated with placebo (twice daily).   "
16498|NCT03069534|"     Multidrug-resistant tuberculosis (MDR-TB) has emerged as a challenge worldwide. Few studies     have prospectively reported outcomes in patients with pulmonary MDR-TB treated with     adjunctive immunotherapy combined to standard chemotherapy. We aimed to assess whether     immunotherapy with Interleukin(IL)-2 enhanced the clinical and immune effects of treatment on     MDR-TB patients.We performed a multicentre prospective cohort study extend all over Jiangsu     province in China. Two groups were generated based on the adjunctive rhIL-2 therapy during 24     months regiman. Bacteriological and imaging data were followed during 24 months with cure     rates analysed.   "
16499|NCT03069521|"     Prospective, feasibility study to evaluate the safety of the EndoArt™ for treatment of 12     subjects suffering from corneal edema. Followed up for 12 months.   "
16500|NCT03069508|"     This study is a phase IIa open label pilot study of up to six months treatment with clemizole     hydrochloride (200 mg vs. 300 mg vs. 400 vs. 500 mg mg) given orally TID to subjects with     hepatocellular carcinoma that are either awaiting transplantation or have an unresectable     lesion.   "
16501|NCT03069495|"     This study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate     asthma and participants with chronic urticaria as compared to healthy adult participants.   "
16502|NCT03069482|"     Quitting smoking has important health benefits for people with serious mental illness, more     than half of whom are smokers. Smoking reductions in this population, in turn, could     contribute to saving billions of dollars in healthcare expenditures.      Finding ways to deliver more effective and wider reaching smoking cessation interventions to     individuals with serious mental illness is a pressing priority. Smartphone apps are a wide     reaching technology that could provide a viable platform to deliver smoking cessation     interventions for individuals with serious mental illness.      However, do smoking cessation apps need to be tailored for people with serious mental illness     to ensure their success? Or can providers simply use standard and freely available smoking     cessation mobile health treatments designed for the general population? Furthermore, is it     feasible to conduct mHealth trials in this population?      Therefore, this trial will test whether (1) a tailored smoking cessation app for people with     serious mental illness results in higher levels of engagement with smoking cessation content     as compared to an app designed for the general population and (2) smoking cessation mHealth     trials can be feasibly conducted in this population.   "
16503|NCT03069469|"     This is a multicenter, open-label Phase 1 study of DCC-3014 in patients with advanced     malignancies, featuring solid tumors, but will also enroll select patients with acute myeloid     leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), or chronic     lymphocytic leukemia (CLL). There will be an Escalation Phase and an Expansion Phase in this     study   "
16504|NCT03069456|"     The investigators want to compare the performance of anesthetic depth monitoring for sedation     (ADMS) to the bispectral index (BIS) as electroencephalographic measures of sevoflurane     effect using two combined sigmoidal Emax models via population pharmacodynamic approach.   "
16505|NCT03069443|"     This Study evaluates the effect of 20 weeks of isometric handgrip (IHG) home training in     adults aged 50 years or more. Half of the participants will serve as a control group and will     only receive hypertension-guidelines on lifestyle changes.   "
16506|NCT03069430|"     This study is being conducted to test an intervention for children and adolescents ages 8-17     years with sickle cell disease and their families. In the first phase of this study, key     informant interviews are being conducted with health care providers and children ages 8-17     with sickle cell disease and their primary caregivers. Participants are asked to review the     intervention and provide feedback that will inform revision to the intervention.   "
16507|NCT03069417|"     The main aim is to conduct a pilot field test of a group-based depression and adherence     counseling intervention with HIV-infected women in the perinatal period. Participants will be     HIV-infected women living in KwaZulu-Natal, South Africa.   "
16508|NCT03069404|"     The investigation is a multi-year observational study following the completion of the     open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC     cells into 12 subjects with thoracic spinal cord injury.      Subjects will be monitored at routine intervals for safety and preliminary efficacy for 5     years post-transplantation of the Phase I/II investigation CL-N02-SC.   "
16509|NCT03069391|"     This study is intended to clarify the benefits to brain health and thinking processes that     result from different forms of exercise. In particular, this study will investigate the     possible benefits of physical exercise (such as pedaling an under-table stationary     elliptical) or mental exercise (such as playing a videogame on a portable tablet), or     combining these activities together (as in the iPACES™ exergame).   "
16510|NCT03069378|"     The purpose of this study is to determine how well the combination of therapy of talimogene     laherparepvec (T-VEC) and pembrolizumab works in the treatment of patients with sarcoma.   "
16511|NCT03069365|"     This Phase 3b, open-label, non-randomized study will evaluate the efficacy and safety of     Glecaprevir/Pibrentasvir (GLE/PIB) for 8, 12, or 16 weeks in in participants with chronic     hepatitis C virus (HCV) genotype (GT) 1 - 6 infection with or without compensated liver     cirrhosis and with chronic renal impairment in both HCV treatment-naïve and prior     treatment-experienced participants.   "
16524|NCT03069196|"     Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of     disease and greater glycemic exposure which makes them more vulnerable towards chronic     complications. The aim of this study is to investigate the prevalence and incidence of micro     and macro-vascular, pulmonary complications and patterns of growth failure in approximately     500 Type 1 Diabetes patients enrolled at Diabetes Unit, King Edward Memorial Hospital     Research Centre. Then follow up of 100 participants who are above 15 years of age at baseline     will be done after 2 years to document incidence and progression of complications. This will     contribute in assessing the public health burden of complications of Type 1 Diabetes.      Factors associated with prevalence of complications will be investigated. This risk factor     analysis could aid in further modifying current prevention and treatment recommendations of     these complications. Results of this study could modify current clinical practice.   "
17301|NCT03059069|"     The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on     depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive     mood could be influence the patient's quality of life and glycemic control.   "
16512|NCT03069352|"     Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white     blood cell responsible for fighting infections). Successful treatment of AML is dependent on     what subtype of AML the patient has, and the age of the patient when diagnosed.      Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a     cell) that allows cancer cells to stay alive. This study is designed to see if adding     venetoclax to cytarabine works better than cytarabine on its own.      This is a Phase 3, randomized, double-blind (treatment unknown to patients and doctors),     placebo-controlled, multicenter study in patients with AML who are 18 or more years old and     have not been treated before. Patients who take part in this study should not be suitable for     intensive induction chemotherapy (usual starting treatment). Abbvie is funding this study     which will take place at approximately 125 hospitals globally and enrol approximately 175     patients. In this study, 2/3 of patients will receive venetoclax every day with cytarabine     and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.      Patients will continue to have study visits and receive treatment for as long as they are     having a clinical benefit. The effect of the treatment on AML will be checked by taking     blood, bone marrow, scans, measuring side effects and by completing health questionnaires.     Blood and bone marrow tests will be completed to see why some people respond better than     others. Additional blood tests will be completed for genetic factors and to see how long the     drug remains in the body.   "
16513|NCT03069339|"     Study Design: Open labeled randomized controlled trial. The study will be conducted on     patients attending outpatient or admitted to admitted to Department of Hepatology from     January 2017 to December 2018 at ILBS, New Delhi   "
16514|NCT03069326|"     The purpose of this study is to test any good and bad effects of the study drugs called     ruxolitinib and thalidomide. Ruxolitinib and thalidomide could shrink the cancer, but it     could also cause side effects.   "
16515|NCT03069313|"     Significant Aromatase Inhibitor-associated toxicity, affects as many as 50% of patients with     breast cancer leading to early discontinuation of this life-saving cancer treatment. No     effective pharmacologic therapy has yet been identified for management of these symptoms, as     many patients do not experience relief of symptoms with analgesic therapy. Vitamin B12,     whether as injection or oral forms, has been used as a naturopathic product to provide relief     for joint pain caused by arthritis. This effect has not been studied in the setting of     Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS).   "
16516|NCT03069300|"     Recent data have suggested that monocyte oxidative burst defect is associated with the     development of infection in patients with severe alcoholic hepatitis. One report found     reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone     when compared to prednisolone alone. The current study seeks to reveal whether the mechanism     by which NAC reduces susceptibility to infection is through improvement of phagocyte     oxidative burst.   "
16517|NCT03069287|"     The aim of this study is to assess the effects of integrating family caregiver support into     cancer clinical trials on the well-being of the caregiver, the care-recipient and on the     cancer clinical trial system.   "
16518|NCT03069274|"     The prevalence of overweight and obesity in children have increased in recent years and this     has been associated with replacing plain water intake by sugar-sweetened beverages.      Because of this, the objective of the present study was to evaluate the impact of a     school-based intervention that aimed to replace sugar-sweetened beverages by water.      A randomized community trial including 314 children aged 9-11 years from three public schools     of the State of Hidalgo, Mexico was performed. Schools were randomized to intervention (two     schools from municipality of Apan; six classes with 146 participants) or control group (one     school from municipality of Emiliano Zapata; six classes with 168 participants) and followed     during 6 months. Intervention included to place water filters at school and classroom lessons     to increase water consumption and decreasing sugar-sweetened beverages.   "
16519|NCT03069261|"     The purpose of this study is to identify and compare complication rates between autologous     breast reconstruction techniques with and without the inclusion on intraoperative indocyanine     green (ICG) angiography.   "
16520|NCT03069248|"     This is a non-comparative, prospective, non-randomized single centre phase II clinical trial     of Rituximab and alpha interferon immunotherapy following autologous stem cell transplant in     patients with relapsed follicular lymphoma conducted at Toronto Sunnybrook Regional Cancer     Centre/Sunnybrook and Women's Health Sciences Centre.   "
16521|NCT03069235|"     This study evaluates strategies aimed at promoting exclusive breast feeding for 6 months     followed by continued breastfeeding for the next 6 months with introduction of complementary     foods among HIV infected women in a resource limited setting.   "
16522|NCT03069222|"     This study will apply novel magnetic resonance imaging (MRI) techniques to investigation of     spinal cord injury (SCI) to learn how nerve fibers repair and neural cells regain ability to     control muscle during the rehabilitation. The information gained will be helpful for     physicians to make more accurate diagnosis of SCI, predict injury recovery and movement     restoration, and develop more effective treatment plans.   "
16523|NCT03069209|"     This is an open label, single arm, single center investigation to assess the safety and     efficacy of purified adult autologous bone marrow derived specific populations of stem cells     and mesenchymal stem cells injected into the ovaries (intraovarian injection), through a 12     week follow-up period. The investigators' chosen model of study is based on increasing the     efficiency of the approach by choosing an autologous model which preserves the genetic     composition of an individual that is vital in infertility conditions. Additionally the     approach involves transplanting a combination of specific purified stem cell types which all     aid in ovarian function recovery.   "
16555|NCT03068793|"     The purpose of this study is to examine the nature of reward processing dysfunctions in     schizophrenia using neuroimaging techniques that capture in vivo brain functioning, such as     EEG and fMRI.   "
16666|NCT03067350|"     Hypothesis: A pharmacogenetic score integrating both CYP3A genotypes could be influence     initial trough voriconazole plasma concentrations and thus useful to adapt a priori     voriconazole dosing in order to get adequate voriconazole exposure as possible after starting     treatment.      Main Objective: To determine predictive value of a combined pharmacogenetic score on onset of     trough voriconazole plasma concentration inferior than lower therapeutic target.   "
16525|NCT03069183|"     Total hip replacement (THR) is a common and major surgical procedure performed in elderly     patients with significant comorbidities. Optimizing a patient's anesthetic and analgesic     modalities could play a significant role in minimizing the risk of adverse events in the     perioperative period and potentially shorten time to discharge and recovery.      Establishing a safe and effective post-operative analgesic plan is of central importance to     successful THR anesthesia care. The application of ultrasound visualization has improved the     efficacy of the fascia iliaca compartment block (FICB). However, ultrasound-guided     suprainguinal FICB has not yet been evaluated clinically in a large trial as a method of     providing post-operative analgesia following THR.      The investigators hypothesize that by performing the suprainguinal fascia iliaca block with     ultrasound, it will be possible to achieve superior and more reliable analgesia in the first     24 hours than without a block.   "
16526|NCT03069170|"     Until now, there is no effective approach to stop the progression of multiple sclerosis and     stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly     developing as an alternative therapy. We propose the use of autologous bone marrow-derived     specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated     with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).   "
16527|NCT03069157|"     Atelectasis is a side effect of general anesthesia which can be found in all types of     interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced     atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients     5, 6 and from 68 to 100% in children with general anesthesia with tracheal intubation or     laryngeal mask.      The aim of this work is to evaluate the effect of lung recruitment on anesthesia induced     atelectasis using intraoperative lung ultrasound.      Objectives        -  To determine the effect of recruitment on anesthesia induced atelectasis using lung          ultrasound.        -  To Estimate the change of Pao2 with anesthesia induced lung atelectasis.        -  To Estimate the change of Pao2 with lung recruitment.        -  To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung          recruitment.   "
16528|NCT03069144|"     Psoriasis, the most prevalent autoimmune disease in the U.S., manifests with plaque type     psoriasis vulgaris with lesions localized to the scalp, postauricular region, face, diaper     area, elbows, and knees. Inadequately controlled disease is common and a significant cause of     extensive psychological and clinical morbidity in children. In addition, the safety and     tolerability issues of common treatments for psoriasis including topical corticosteroids,     calcipotriol, oral cytotoxic drugs, and biologic agents are especially problematic in     patients that limit their use. Identification of therapies with high efficacy and safety     profiles suitable for patients with psoriasis is therefore an area of critical unmet need.     Haus Bioceuticals has developed a topical treatment for psoriasis denoted HAT1 (based on     ingredients that have established clinical benefit), and further have demonstrated that HAT1     is safe and profoundly effective in the treatment of psoriasis. This study is aimed to     further evaluate the efficacy and safety of HAT1 compared to commonly used calcipotriol in     patients with mild to moderate chronic plaque psoriasis.   "
16529|NCT03069131|"     We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the     center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in     'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month     survival.   "
16530|NCT03069118|"     Individuals indicating risky substance use are randomly assigned either to a three-month     online intervention on the Workit Health platform or a waitlist/treatment as usual. Those     randomized to treatment will report reduced consumption of alcohol and other drugs and higher     quality of life at study conclusion.   "
16531|NCT03069105|"     This study will look at caregiver burden and the coping behavior of caregivers of patients     with cancer. Through this study, the investigators will identify the relationship between     cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social     support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression     among family caregivers of patients with cancer.   "
16532|NCT03069092|"     As the leading cause of death, cardiovascular disease (CVD) accounts for about one-third of     U.S. mortality. Physical inactivity, one of the main CVD risk factors, causes 6% of coronary     heart disease worldwide. The American Heart Association has identified cardiovascular health     behaviors including smoking, obesity, diet, and aerobic exercise; however, resistance     exercise was not included due to the limited evidence of its efficacy. Comparatively, the     cardiovascular benefits of aerobic training have been well-documented whereas the independent     and additive benefits of resistance training on cardiovascular health have not been     established. Thus, this project is aimed to answer one of the most common questions about     exercise and health:What type or combination of exercise is most effective for CVD     prevention? This project will significantly contribute to developing more effective CVD     prevention approaches, advancing more comprehensive physical activity guidelines, and     providing important insights and novel opportunities for the future science of physical     activity and health.   "
16688|NCT03067064|"     The purpose of this study is to find out the prevalence of molar incisor hypomineralization     among a group of Egyptian children   "
16689|NCT03067051|"     The rationale for the study is to obtain safety data as well as to establish dose parameters     for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as     photosensitizer for the treatment of recurrent prostate cancer.   "
16533|NCT03069079|"     Title: Investigation of neutrophil defects associated with periodontal disease and tooth loss     in children. A clinical study.      Objectives: The primary objective of this study is:        -  To investigate presence of periodontal disease and response to periodontal treatment in          children affected by neutrophil defects      The secondary objectives of this study are:        -  To investigate presence of other dental diseases in children affected by neutrophil          defects        -  To assess oral microbiological and inflammatory parameters in children affected by          neutrophil defects      Primary outcomes: The primary outcomes are (a) presence of periodontal disease as assessed by     clinical factors: probing pocket depth, attachment level, bleeding on probing and     radiographic bone loss) (b) microbiological and host response factors: detected in     periodontal pockets and gingival crevicular fluid and (c) response to treatment      Study sample: Children affected by neutrophil defects and meeting outlined inclusion and     exclusion criteria      Number of participants: 50 children      Study design: This is a longitudinal treatment study. All participants will attend for 4-7     visits during the study as outlined below:        -  Screening visit (visit 1): consent procedure, dental examination, saliva and plaque          sampling        -  Baseline visit (visit 2):, detailed periodontal examination, dental radiographs,          sampling of gingival crevicular fluid and, if appropriate scaling, polishing and oral          hygiene instructions        -  Non-surgical periodontal treatment (visit 3A to 3D, max 4 sessions): oral hygiene          instructions and supra- and sub-gingival debridement (under local anaesthesia if          necessary)        -  Follow-up Visit (visit 4, 4th to 7th visit) (six months following treatment): detailed          dental examination, oral hygiene instructions, sampling of saliva, subgingival plaque          and gingival crevicular fluid, tooth scaling and polishing.   "
16535|NCT03069053|"     Objectives- to find out whether a correlation exists between denudation of urothelium and     diagnosic delay in patients with BPS / IC, secondary aim was to search a correlation between     impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with     BPS-IC.      Patients and Methods- Fifty-seven consecutive patients underwent cystoscopy under anaesthesia     to classify those cases suspected of BPS/IC. As for the evaluation of the ICSI-ICPI scores we     considered significant relevant values those ≥ 12. Patients underwent cystoscopy with     hydrodistension under general (90%) or locoregional anaesthesia. Bladder biopsies were taken,     including detrusor muscle, from those areas with the most apparent bladder wall lesions. All     biopsies were then fixed in 4% formalin and sent to the Pathologist for examination.   "
16536|NCT03069040|"     Cervical cancer in young patients increased significantly in recent years, and early surgical     treatment for patients with 5 years of survival rate is as high as 90%, But the traditional     extensive hysterectomy (RH) caused by intraoperative pelvic autonomic nerve may damage the     bladder and rectum and the incidence of complications such as sexual dysfunction is nearly     25% to 80%, thus seriously affect the patient's quality of life.Pelvic autonomic nerve     preservation system of extensive hysterectomy (NSRH) can decrease the complications of above,     but at home and abroad mainly adopts pulling the urine tube time, determination methods of     residual urine volume, bladder function are studied in only a few scholars urine flow     mechanics method is applied to carry on objective appraisal limited cases of postoperative     bladder function, and the anorectal function damage ，we can use the anorectal dynamics to get     objective index of anorectal function .overall research lack of large sample research of     dynamic system. No objective index to evaluate the anorectal function In the early stage of     the study, we have conducted about uterine ligament, sacral ligaments and nerve distribution     of the bladder cervix vaginal ligament of experimental research, provide the neural anatomy     basis for NSRH operation, and based on research for innovative operation scheme is put     forward.Proposed on the basis of the above research, this study adopt the internationally     used - urine flow mechanics, the method for evaluating the bladder function of NSRH, RH, two     kinds of the injured function of bladder surgery patients before and after operation of     comparative study, the change of dynamic assessment before and after surgery in patients with     bladder function,and the anorectal function dameage and than provide the basis for further     treatment.   "
16537|NCT03069027|"     Emergence agitation following general anaesthesia may lead to serious complications like     self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia,     bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence     agitation. The investigators planned to evaluate the efficacy of external nasal nerve block     in prevention of postoperative agitation following external nasal surgeries under general     anesthesia(GA).   "
16538|NCT03069014|"     The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 120     patients with Alzheimer's Disease versus placebo and to access biomarker and clinical     exploratory endpoints of LM11A-31-BHS   "
16539|NCT03069001|"     This prospective study was conducted at Ain Shams University Hospital, Internal Medicine,     Hepatology and Gastroenterology Department, and Tropical Medicine Department.      To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the     combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related     Child A cirrhosis.   "
16540|NCT03068988|"     The prospective randomized clinical study investigating the effect of mesenchymal stem cells     on tendon healing. The objective of the study is to demonstrate the effect of concentrated     bone marrow stem cells ( MSCs ) to the healing of sutured tendon of the supraspinatus muscle     in comparison to the same procedure performed without MSCs. We have postulated the hypothesis     that MSCs enhance the healing of the sutured supraspinatus tendon to its humeral footprint.   "
16541|NCT03068975|"     To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an     emergency trauma setting without the pre-operative dosage in patients that will receive     abdominal surgery.   "
16542|NCT03068962|"     Dietary nitrate have been shown to have health benefits including lowering blood pressure     (Hobbs et al, 2012), improving endothelial function and inhibiting platelet aggregation in     healthy humans (Lidder & Webb, 2013). The main sources of dietary nitrate in the human diet     are vegetables such as beetroot. Nitrates are converted to nitrites then nitric oxide (NO),     following their reduction by commensal oral bacteria and those residing in the     gastrointestinal tract (Hord, Tang, & Bryan, 2009; Lidder & Webb, 2013). A recent study has     shown following elimination of oral bacteria by the use of a chlorhexidine based antiseptic     mouthwash, the conversion of nitrate to nitrite is prevented and this is accompanied by a     statistically significant increase in blood pressure in normotensive subjects (Kapil et al.,     2013). To date, very few studies have investigated the potential role of these oral bacteria     in control of blood pressure and if there are any inter and intra-individual differences in     bacterial composition.   "
16543|NCT03068949|"     This study will evaluate in detail the way that the immune system responds to three different     kinds of flu shots that are licensed in the United States.   "
16544|NCT03068936|"     Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong     Province. In the world, the standardized morbidity has reached 30/10 million in men while in     women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China     accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which     is a serious threat to our people's health and life. A recent multi-center phase II study of     stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation     Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate,     distant metastasis-free survival rate and disease-specific survival rate of IMRT were     similar, but the side effects of radiotherapy alone group were lower.      Based on the results of the phase II clinical study, the investigators designed this phase     III clinical study, with the aim to compared the efficacy and toxicity of these two treatment     programs. And finally to provide sufficient evidence for the treatment of stage II     nasopharyngeal carcinoma.   "
16547|NCT03068897|"     This is a randomized study, based in emergency departments, in which the investigators     determine the utility of adding various skeletal muscle relaxants to standard therapy, which     consists of ibuprofen and an educational session. Patients will be enrolled at the time of an     emergency visit and followed for three months to determine outcomes.   "
16548|NCT03068884|"     Behavioural or cognitive flexibility (BF) is an essential ability which allows an organism to     adaptively change responses in accordance with feedback of results. In humans, this ability     is disrupted among those who suffer a variety of neurological and psychiatric conditions     including Parkinson's disease, schizophrenia, addiction, obsessive compulsive disorder and     autism. Additionally, there is evidence of substantial individual differences in BF within     the healthy population.      Two known neurobiological mechanisms which relate to BF performance are variation in dopamine     (DA) and serotonin (SE) function. One particular brain regions which has been heavily     implicated in BF is the prefrontal cortex (PFC), with the dorsolateral PFC receiving a     largely DA innervation and the dorsomedial PFC a SE input. Studies have demonstrated that     damage to parts of PFC including the orbitofrontal cortex (OFC), for example, impairs     reversal learning (a form of BF) whereas lesions of the dorsolateral PFC affect attentional     set-shifting (another measure of BF).      In humans, putative augmentation of DA efflux via administration of the DA and norepinephrine     precursor tyrosine has been shown to improve task-switching performance, and inhibitory     control suggesting a causal role of DA in regulating BF. Similarly, putative depletion of     serotonin neurotransmission via tryptophan depletion procedures has been shown to reduce the     BOLD response during performance monitoring and increase perseverative behaviour.      One important strategy (in humans) to observe whether the PFC is causally involved in BF     performance, is by reversible electrical stimulation of the PFC, so that PFC cells could be     inhibited or excited while a participant is performing a BF task. In recent years, several     laboratories have taken advantage of a relatively new technology known as transcranial direct     current stimulation (tDCS) to study the relationship between brain function and behaviour.     Using this technique, increases or decreases in cortical excitability are partly determined     by the polarity of the stimulation; increases occur under the anode electrode whereas     decreases occur under the negatively charged cathode.      Using this approach, several studies have shown that anodal and cathodal stimulation over the     PFC can have a number of effects on BF performance, with general improvements during anodal     stimulation and impairments during cathodal. If this is the case, one important step that     remains to be understood is whether dopamine and serotonin are causally related to these     outcomes when neurons of the dLPFC/dMPFC are either excited or inhibited via tDCS.      Thus, the specific novelty of this study rests in combining a psychopharmacological approach     (i.e. tyrosine/tryptophan loading) with selective neuroanatomical (i.e.     dorsolateral/dorsomedial prefrontal cortex) inhibition of cells via tDCS while participants     are performing BF tasks. By doing so, we will be able to establish whether increased     dopaminergic/serotonergic output to the PFC is a necessary requirement for BF performance.   "
16552|NCT03068832|"     The early clinical development paradigm for chemotherapeutic agents has significantly     influenced the development of therapeutic cancer vaccines. However, there are major     differences between these two classes of therapeutics that have important implications for     early clinical development. Specifically, the phase 1 concept of dose escalation to find a     maximum-tolerated dose does not apply to most therapeutic cancer vaccines. Most therapeutic     cancer vaccines are associated with minimal toxicity at a range that is feasible to     manufacture or administer, and there is little reason to believe that the maximum-tolerated     dose is the most effective dose.      In a recent article from the biostatistics literature, Simon et al. write that the initial     clinical trial of many new vaccines will not be a toxicity or dose-ranging trial but rather     will involve administration of a fixed dose of vaccine … in most cases the dose selected will     be based on preclinical findings or practical considerations. Using several dose levels in     the initial study to find the minimal active dose or to characterize the dose-activity     relationship is generally not realistic.      Consistent with these recommendations, the general philosophy of the phase 1 clinical trial     is to facilitate a prompt preliminary evaluation of the safety and immunogenicity of the     personalized synthetic long peptide vaccine strategy. The proposed clinical trial will test a     fixed dose of vaccine. There is considerable experience with the synthetic long peptide     vaccine platform. The synthetic long peptide vaccine platform has an excellent safety     profile, and the optimal dose appears to be based on practical considerations (solubility of     the peptide). The dose to be tested in the proposed clinical trial is consistent with other     similar cancer vaccine trials that have been recently completed or are currently ongoing. The     sample size (n=10-20) will provide a reasonably reliable estimate of the safety and     immunogenicity of the vaccine.   "
16553|NCT03068819|"     Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely     used treatment approaches in patients who relapse after allogeneic hematopoietic cell     transplant (allo-HCT). However, the complete remission (CR) rates and long term survival     remain very poor in these patients and, therefore, there is an unmet need to develop more     effective treatment approaches in patients who relapse after allo-HCT.      Based on the initial promising results with our ongoing cytokine-induced memory-like (CIML)     natural killer (NK) cell trial, the investigators hypothesize that combining the CIML NK     cells with DLI approach will significantly enhance the graft versus leukemia and therefore     potentially provide potentially curative therapy for these patients with otherwise extremely     poor prognosis. Combining CIML NK cells with the DLI platform will also potentially allow     these adoptively transferred cells to persist for longer duration as they should not be     rejected by donor T cells as the CIML NK cells are derived from the same donor. The use of     CIML NK cells is unlikely to lead to excessive graft versus host disease (GVHD) as previous     studies have not been associated with excessive GVHD rates.   "
16758|NCT03066193|"     This is an investigator-initiated proof of concept study with the purpose to examine the     safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the     treatment of adults with Tourette syndrome.   "
16556|NCT03068780|"     This is a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited     Epidermolysis Bullosa (EB).      EB is a rare group of genetic skin fragility disorders characterised by blistering of the     skin in response to minor injury. In most cases, onset of EB is at birth or shortly after.     All participants affected by any type of EB share the main characteristic of repeatedly     developing painful wounds that take days to months to heal. Current treatment of EB is     primarily preventative and supportive including protection from mechanical forces by avoiding     rubbing, early treatment of wounds to prevent infections, and protection of the wound with     adequate non-adhesive dressings to enable healing.      Oleogel-S10 was authorised in 2016 in the European Union for treatment of partial thickness     wounds in adults under the brand name Episalvan®. The active pharmaceutical ingredient in     Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.      This clinical study of Oleogel-S10 in patients with inherited EB has been initiated to     investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe in the long     term use.      Oleogel-S10 will be compared to a vehicle gel placebo. The placebo is an identical looking     sunflower oil gel that does not contain any active substance. The participant will receive     either Oleogel-S10 or vehicle gel for a double-blind study phase of 90 days. The probability     that the participant will receive Oleogel-S10 is 50%, which means that they have a 1 in 2     chance of receiving Oleogel-S10. However, in the follow-up phase of the study all     participants will be treated with Oleogel S10 for a period of 24 months.      This clinical study will be performed in several countries; in total, about 164 participants     are expected to participate.   "
16557|NCT03068767|"     300 HBV carriers with inadequate serum vitamin D levels were randomized to two groups: one is     supplied with vitamin D and another without as controls. The markers of HBV replication were     compared before and after treatment.   "
16558|NCT03068754|"     This is a multicenter, multiple dose study to examine the effect of H.P. Acthar® (Acthar) on     functional decline in adult subjects with amyotrophic lateral sclerosis (ALS).   "
16559|NCT03068741|"     Sepsis occurs when a serious infection - most commonly infection of the lungs, urinary     system, or blood - leads to acute organ failure. It is a common, expensive, and frequently     lethal condition. A growing body of evidence suggests that early recognition and treatment of     sepsis can improve survival.      Unfortunately, many patients with sepsis do not receive key therapies until physicians     working in Emergency Departments have assessed them - often introducing marked delays. It is     estimated that one‐half of patients with sepsis are treated and transported to hospital by     paramedics. This allows paramedics a unique opportunity to provide early treatment at the     initial point of patient contact, thereby decreasing the time to treatment for these     critically ill patients. This randomized controlled trial will evaluate whether prompt     recognition followed by early antibiotics and/or intravenous fluids delivered by paramedics     in the field leads to improved survival, compared to usual care, for patients who are     transported to the hospital with sepsis.   "
16560|NCT03068728|"     This study is a prospective comparison between absorbable hemostatic agents as a group and     the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral     sinus surgery with or without septoplasty.   "
16561|NCT03068715|"     This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial     magnetic stimulation device for treatment-resistant depression. In a double-blind fashion,     half the participants will receive accelerated theta-burst stimulation while half will     receive sham treatment.   "
16562|NCT03068702|"     Sickle cell maculopathy was sparingly mentioned in the literature before despite the fact     that sickle cell disease or sickle cell trait is common in people of many areas of the world.     This study shows that OCTA is a very valuable, non invasive, office procedure that may well     be used in diagnosing this disease.   "
17348|NCT03058458|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     different single and repeat doses of PIN201104 in healthy volunteers and in patients with     asthma.   "
16564|NCT03068676|"     The current study is an open feasibility trial with the aim of providing a description of the     factors associated with the implementation of an iCBT platform into an existing treatment     framework in a primary care setting. The trial will examine the factors surrounding     implementation, such as the experience of primary care practitioners and the online     supporters, the recruitment process, and attitudes towards the overall implementation of the     interventions. Patients presenting to the primary care setting will be screened using     standard depression and anxiety measures, and where appropriate, will be referred to an iCBT     intervention for either depression or anxiety, with support from trained staff. Analyses will     be conducted on outcome measures to examine changes in symptom severity as patients progress     through the intervention. Patient satisfaction data will also be collected to establish     patient acceptability of the intervention. [Note: Recruitment is ONLY open to patients at     Ohio Family Practice Center]   "
16565|NCT03068663|"     The subject is to study the lung microbiota and the one of upper airways (UAs) (much less     studied than the intestinal microbiota) in 40 patients having lung cancer. 20 patients     undergo only surgical treatment, while other half receives also chemotherapy. The idea is to     explore changes in microbiota of the lung, upper UAs and intestine, and potentially find     associations between them. These results will serve us as a base for the future study,     focused on manipulation of the microbiota by prebiotics, probiotics or symbiotics and its     effect on anti-cancer treatment tolerance and effectiveness.   "
16566|NCT03068650|"     Celldex endeavors to make investigational products available to patients with     life-threatening diseases who have exhausted other treatment options and where there is a     reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in     patients with EGFRvlll expressing recurrent glioblastoma will be considered.   "
16567|NCT03068637|"     The overarching objective of this study is to evaluate the feasibility, usability, and     acceptability of an abbreviated, tablet-based geriatric assessment in a population of older     adults with multiple myeloma.   "
16568|NCT03068624|"     The goal of this clinical research study is to learn about the safety of giving CD8+T cells     with ipilimumab, cyclophosphamide, and IL-2 (aldesleukin) to patients with uveal melanoma     that is metastatic (has spread). Researchers also want to learn if this combination can help     to control the disease.   "
16569|NCT03068611|"     The overall objective of this project is to develop and pilot-test a web-based smoking     cessation program that specifically addresses heavy drinking (HD). The project builds upon a     well-established, free evidence-based smoking cessation website, BecomeAnEX.org (EX), which     is supported by Truth Initiative, a national non-profit public health organization, and its     research arm, the Schroeder Institute. Investigators will develop an alternative version of     BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse,     health effects of alcohol (including moderate drinking recommendations) along with related     worksheets, feedback materials, and links to resources for drinking. Once a version of     BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will     conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered     BecomeAnEX users. The study will gather participant feedback on the site as well as site use     metrics (e.g., number of logins, number of pages viewed, use of interactive components) and     will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b     will use the updated EX-HD version to run a small scale randomized clinical trial where 120     participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.   "
16570|NCT03068598|"     Promising results have shown that interventions to reduce insomnia diminish suicidal     ideation. A better understanding of the bidirectional mechanism between sleep disturbances     and suicide behavior will allow the design of tailored interventions to prevent suicide     attempts.      Significance of the proposed study for the field The aim of the present is to assess the     feasibility and the acceptability of sleep tracking monitoring in a sample of suicide     attempters. The investigator hypothesize that sleep monitoring using a connected object is     feasable and acceptable by patients.   "
16571|NCT03068585|"     In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic     lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V.     Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This     study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165     gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The     study was conducted under the control of the Russian Ministry of Health and was completed in     2011. Patients enrolled in the study were subjected to a 6-month   "
16572|NCT03068572|"     Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright     endoscopic images by using short-wavelength narrow-band laser light combined with white laser     light on the basis of magnifying blue laser imaging(BLI) technology.LCI makes red areas     appear redder and white areas appear whiter.Thus,it is easier to recognize a slight     difference in color of the mucosa.This is a study to assess the effectiveness of LCI for     diagnosing esophageal minimal endoscopic lesions and Los Angeles classification system when     compared to conventional white-light endoscopy (WLI).Gastroesophageal reflux disease(GERD) is     a common disease that be defined as a condition which develops when the reflux of stomach     contents cause troublesome symptoms and/or complications.Esophageal injury was classified     according to the Los Angeles classification system,Non-erosive reflux disease(NERD) is     defined by the presence of troublesome reflux-associated symptoms and the absence of mucosal     breaks at endoscopy,which includes minimal change oesophagitis and no endoscopic     abnormalities.LCI improved the visualization of the squamocolumnar junction (SCJ) by     enhancing the contrast,mucosa minimal changes could be seen more easily and clearly with LCI     than with standard white-light endoscopy.By comparing White-light endoscopy and LCI,it will     show if there is any comparable advantage to using one or the other for lesion detection.   "
16634|NCT03067766|"     This pilot clinical trial studies how well comic art creation works as supportive care in     cancer patients and caregivers. Participating in a comic art creation workshop may help     patients and their family members or friends share their medical experience through     storytelling and drawings in a way that can, but does not have to, reflect the real world. It     may also help improve emotional wellbeing and communication in cancer patients and     caregivers.   "
16635|NCT03067753|"     Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis   "
16573|NCT03068559|"     The aim of the present prospective study was to assess dysphagia (occurrence, severity,     length) in head and neck cancer (HNC), from diagnosis to 18 months after their first line     treatment regardless of the treatment. The investigators have complied with the pre-listed     clusters.      For this purpose, pursuant to consensus on the dysphagia assessment, the investigators used     the Deglutition Handicap Index (DHI) questionnaire (Silbergleit 2012) for dysphagia screening     and patient's self-perception. This was the only questionnaire validated in French evaluating     the swallowing function by the patient (Woizard 2006).      Clinical evaluation according to NCI-CTCAE v4.0 criteria and objective measures of swallowing     function were also recorded and compared to DHI results.   "
16626|NCT03067870|"     Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic     inflammation in the synovial tissue. Rheumatoid arthritis ultimately results in the     destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis     is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has     anti-inflammatory and regenerative effects and thus potentially alleviates the progression of     rheumatoid arthritis. The study is to explore the safety and efficacy of BM-SC     transplantation in treatment of rheumatoid arthritis.   "
16627|NCT03067857|"     Herein, the investigators study the safety and efficacy of transplanting purified autologous     bone marrow-derived stem cells transplanted via the intrathecal route by interventional     radiology and the intravenous route.   "
16575|NCT03068533|"     Dentinal hypersensitivity [DH] is a common condition in daily practice, especially in     patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect     individuals in the age range of 20-50 years.In a recent systematic review, it was reported     that no gold standard treatment modality for dentin hypersensitivity has been established     Thus there is a need to evaluate new formulations in different settings and in different     populations and to compare those to commonly used agents seeking better results in pain     relief for our patients. Studies showed that dentifrice formulations containing 8% arginine     in combination with calcium carbonate and fluoride have the ability to plug dentinal tubules,     by clumping of both arginine and calcium carbonate that bind with the negatively charged     dentin . Aim of the study is to clinically evaluate toothpaste containing 8% arginine,     calcium carbonate, and sodium mono-fluorophosphate, in comparison to toothpaste, containing     8% strontium acetate and NaF on the relief of DH in chronic periodontitis patients.   "
16576|NCT03068520|"     PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details     will be performed on set intervals to patients with brain tumor & brain metastases in order     to try to optimize the study protocol, distinguish between pseudo-response to anti-angiogenic     therapy and tumor progression, and most importantly try to distinguish between progressive     tumor and treatment related effects.3 cohort of patients will be included in the study.   "
16577|NCT03068507|"     The process of enhancing an individual's functional capacity to optimize physiologic reserves     before an operation to withstand the stress of surgery has been coined prehabilitation. This     is a prospective randomized controlled trail, designed to explore if the patients who take     thoracoscopic lobectomy for lung cancer will benefit from family trimodal prehabilitation     strategy. Trimodal prehabilitation includes exercise, nutrition supplement and physiology     management preoperatively. It starts from the day that patients decide to take the surgery     until the day before surgery, lasting 2~3 week in our hospital. And we follow-up patients     until 8 weeks after surgery to investigate if trimodal prehabilitation strategy can improve     the postoperative functional recovery，reduce complications and improve prognosis.   "
16578|NCT03068494|"     The COBIS III registry is a multi-center, real-world registry of 2nd generation drug-eluting     stenting in coronary bifurcation lesions in South Korea. From 31 major coronary intervention     centers in Korea, a total of 3,000 patients (anticipated) will be enrolled in this database     between January 2010 and December 2014.      The aim of the study was to investigate long-term clinical results and predictors of adverse     outcomes after percutaneous coronary intervention with 2nd generation drug-eluting stents for     coronary bifurcation lesions in South Korea.   "
16579|NCT03068481|"     The purpose of this study in healthy adult males is to investigate safety and     pharmacokinetics of single and multiple oral doses of KDT-3594.      The purpose of this study in patients with Parkinson's disease is to investigate safety and     pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of     KDT-3594 will also be investigated.   "
16580|NCT03068468|"     The purpose of this study is to determine the efficacy and safety of intravenously     administered BMS-986168 in participants with Progressive Supranuclear Palsy.   "
16581|NCT03068455|"     The purpose of this study is to determine whether an investigational immunotherapy Nivolumab,     when combined with Ipilimumab, is more effective than Nivolumab or Ipilimumab by itself, in     delaying the return of cancer in patients who have had a complete surgical removal of stage     IIIb/c/d or stage IV Melanoma.   "
16582|NCT03068442|"     The invesigators propose a clinical study on patients undergoing carotid surgery     (endarterectomy). The invesigators will determine carotid artery imaging features associated     with (1) vessel wall inflammation, (2) downstream brain inflammation, and (3) cognitive     benefit from surgery. This project will uncover links between inflamed carotid plaque and     downstream brain inflammation. The invesigators will also determine carotid plaque imaging     features predicting cognitive benefit from carotid surgery.   "
16583|NCT03068429|"     24 OCD patients and 24 healthy subjects will be submitted to a two-day fear conditioning     paradigm during acquisition of functional magnetic resonance imaging (fMRI). OCD patients     will be submitted to the paradigm at two timepoints: baseline and 4 weeks after treatment     initiation with sertraline up to 200mg/day or maximum tolerated dosage. OCD patients are     expected to demonstrate worsened extinction retention compared to healthy subjects at     baseline. Sertraline treatment is expected to improve extinction retention compared to     baseline and to normalize the brain regions being recruited with the conditioned stimuli     presented during the recall phase.   "
16584|NCT03068416|"     Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting     chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy.   "
16656|NCT03067480|"     To determine whether 3-month versus 6-month professional CGM utilization improves time spent     in target range of 70-140mg/dl in patients with poorly controlled T2DM not treated with     insulin.   "
16585|NCT03068403|"     In recent years the concept of organ sparing treatment in rectal cancer was introduced for     selected good responders after neo-adjuvant treatment. In these patients replacement of the     standard of care total mesorectal excision (TME) by transanal endoscopic microsurgery (TEM)     or omission of surgery after chemoradiation (CRT) was proposed. Before organ sparing     treatments could be applied in clinical practice a reliable patient selection procedure has     to be available as only good treatment responders after neo-adjuvant therapy are candidates     for such adapted therapy. Different imaging modalities have been studied for their ability to     distinguish good treatment responders from others. Examples of such imaging modalities with     some promising results regarding response assessment are fludeoxyglucosepositron emission     tomography (FDG-PET), T2-weighted magnetic resonance imaging (T2w-MRI), dynamic contrast     enhanced magnetic resonance imaging and diffusion weighted MR imaging (DW-MRI). Besides these     modalities dynamic contrast enhanced ultrasound (D-CEUS) is a new modality used for tissue     characterization and therapy response assessment in several tumor locations, like liver     tumors and breast cancer. D-CEUS reflect tissue vascular perfusion. For rectal cancer, the     value of D-CEUS for pathological response prediction and assessment has never been assessed.     Therefore, in this study we assessed D-CEUS to predict and assess pathological response in     rectal cancer after neo-adjuvant CRT.   "
16649|NCT03067571|"     The goal of this clinical research study is to learn if daratumumab can help to control acute     myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that is refractory     (does not respond to treatment) or relapsed (comes back after being treated).      The safety of this drug will also be studied.   "
16586|NCT03068390|"     The investigators are testing a two-group, randomized, controlled trial with 280 primary     caregivers of adult patients with a chronic illness to test the efficacy of the Rural     Intervention for Caregivers' Heart Health (RICHH). Immediate (4-month) and long-term     (12-month) effects of the RICHH intervention on CVD risk factors, self-management behaviors,     and depressive symptoms will be compared to usual care. The investigators also will test the     moderating effect of gender on intervention outcomes, given the many differences between male     and female caregivers.      Specific Aim 1: To determine effects of the RICHH intervention on the primary outcomes of CVD     risk factors (i.e., lipid profile, body mass index, and blood pressure) at 4 and 12 months.      Hypotheses 1: The intervention group will have better lipid profile, body mass index, and     blood pressure outcomes than the usual care group at 4 and 12 months.      Specific Aim 2: To determine effects of the RICHH intervention on self-management behaviors     (i.e., diet quality, physical activity level, and self-report adherence to specific CVD     health behaviors).      Hypotheses 2: The intervention group will have better diet quality, higher physical activity     levels, and better adherence to specific CVD health behaviors than the usual care group at 4     and 12 months.      Specific Aim 3: To determine effects of RICHH on depressive symptoms at 4 and 12 months.      Hypotheses 3: Caregivers receiving the intervention will have lower levels of depressive     symptoms than caregivers receiving usual care at 4 and 12 months.      Specific Aim 4: To evaluate whether intervention effects on outcomes will differ by     caregivers' gender.      Hypotheses 4: Effects will be stronger for male compared to female caregivers at 4 and 12     months.      Impact: The proposed study will have a substantial impact on caregivers' cardiovascular     health and quality of life because it will provide needed CVD risk prevention, and health     promotion to rural caregivers living in distressed environments where CVD risk reduction and     self-management is difficult. The intervention holds the potential to produce major     improvements in health among caregivers living in rural environments in the US.   "
16587|NCT03068377|"     Objectives: To determine LYC-001e's influences on ocular blood flow Ocular blood flow has     been implicated as a parameter relevant to eye health and involved in the disease process of     several ophthalmic pathologies including AMD, glaucoma, and diabetes we hypothesis that     LYC-001e will increase measures of ocular blood flow in healthy individuals      Methods: This is a single-phase, randomized, parallel, double blind , comparative study of     LYC-001e versus placebo on ocular blood vessels in healthy individuals.   "
16588|NCT03068364|"     Risk stratification of hypertensive patients includes assessment of traditional     cardiovascular risk factors and subclinical target organ damages particularly left     ventricular hypertrophy (LVH).      LVH may routinely screened by transthoracic echocardiography by measuring the left     ventricular mass (LVM).      However, transthoracic echocardiography suffers from several pitfalls: poor reproducibility,     technical limitations and unavailability at a first evaluation by general practitioners.      Other biomarkers may be particularly helpful in hypertension risk stratification. The     amplitude of the R wave in aVL lead is a simple validated ECG parameters of LVH and a strong     predictor of cardiovascular events and mortality.      Plasma N-terminal pro Brain Natriuretic Peptide (NT-proBNP) is also strongly related to LVM     and is an independent predictor of all-cause mortality in hypertension.      The main objective of our study is to determine the additive prognostic value of R wave in     aVL and NT proBNP on all-cause and cardiovascular mortality.      Secondary objectives are to determine the addition prognostic value of NT-proBNP and R wave     in aVL combined in comparison to each marker taken into account      This study will include 1600 patients who had a work-up of their hypertension in the     Cardiology Department of Croix-Rousse Hospital (Hospices Civils de Lyon, Lyon, France) from     January 1997 to January 2014.      Their data will be collected in an Access database; their vital status will be obtained by     the INSEE unit CépiDC.   "
16589|NCT03068351|"     This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and     tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants     with relapsed/refractory multiple myeloma. There are two parts to this study. A     dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose     limiting toxicities, and to establish the maximum tolerated dose/optimum biological dose of     RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion     phase (Part II) will further characterize the safety, tolerability and activity of RO6870810     as monotherapy or in combination with daratumumab at the defined expansion dose-levels.   "
16590|NCT03068338|"     The research team's aim is to investigate the effects of the team's soft robotic socks in     providing assisted ankle dorsiflexion-plantarflexion and promoting venous blood flow in     stroke patients. Specifically, the investigators intend to 1) observe the development of     joint contracture in terms of the range of motion of the ankle joint given the use of the     device 2) monitor the presence of blood clots in the deep veins using compression Duplex     ultrasonography given the use of the sock device.      The investigators hypothesize that a soft robotics approach can provide compliant actuation     to simulate natural ankle dorsiflexion and plantarflexion, which will consequently promote     blood circulation in the lower leg of stroke patients who have not previously developed ankle     joint contracture. This will prevent the occurrence of DVT and movement in the ankle joint     will alleviate stiffness. This robotic sock intervention is to prevent the development of     ankle joint contracture so established ankle contractures will be excluded from this study.   "
16657|NCT03067467|"     This is a non-randomized, purely observational, feasibility study to detect metabolic changes     in patients with brain malignancy using a novel hyperpolarized [1-13C]pyruvate MRSI.   "
20129|NCT03022084|"     The purpose of this study is to determine if a novel sound-based therapy in comparison to     standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects     for people with bothersome tinnitus.   "
16591|NCT03068325|"     This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of     trauma-focused Equine-Assisted Therapy (EAT) for veterans with posttraumatic stress disorder     (PTSD). While several well-studied, validated treatments for PTSD exist, some individuals     find these treatments ill-suited, ineffective, or undesirable. EAT is an alternative therapy     widely used by organizations, such as PATH International Equine Services, that endorse its     effectiveness for treating a variety of mental health issues. These claims have drawn     criticism because the published research contains glaring methodological flaws, making it     difficult to assess how effective these therapies actually are (Anestis et al., 2014).     Equine-assisted therapies present a unique treatment modality that might effectively treat     PTSD, particularly for individuals who have difficulty with other treatment modalities. In     EAT, a psychotherapist and equine specialist work together to help the patients negotiate     interactions with a horse using structured interventions or activities.   "
16592|NCT03068312|"     This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of     age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.   "
16605|NCT03068143|"     This prospective observational study is designed to investigate the relationship between     brain temperature, axillary temperature, rectal temperature, and bladder temperature of     postoperative patients with brain trauma, and the relationship between brain temperature and     prognosis. This study is conducted based on the following important assumptions. First, brain     temperature of postoperative patients with brain trauma should be higher than the axillary     temperature, rectal temperature and bladder temperature. Second, the consistency of brain     temperature and bladder temperature is better than the consistency of brain temperature and     axillary temperature, as well as that of brain temperature and rectal temperature. Third,     brain temperature can help clinicians to predict the prognosis of patients with brain trauma.     Therefore, brain temperature monitoring is significant in postoperative intensive care and     treatment of patients with brain trauma.   "
16593|NCT03068299|"     This research aims to analyze the effects of senior dance on the cognition, frailty, and     burden in elderly caregivers of rural communities. This is a randomized clinical trial to be     conducted with a sample of 58 elderly caregivers residing in rural communities. Data     collection will be performed in the homes of the elderly and/or in the dependencies of the     Family Health units (USFs - primary health care systems). They will answer Socio-demographic     characterization instrument, ACE-R Battery, and electroencephalography for cognitive     evaluation, five Fragility criteria proposed by Fried et al and Zarit Burden Inventory. The     dance protocol will be applied to the experimental group (n=29) in the USFs and the control     group (n=29) will receive health care, including guidance on health care and practices. The     protocols include 24 interventions, 60 minutes each, weekly, during 6 months. Analysis of     effects comparisons will be conducted between groups and be comparing baseline with final     measurements. Dance intervention is expected to exert important positive effects on all study     variables (cognitive performance, fragility assessment, and caregiver burden), compared to     the group. The intervention of the control group is expected to exert positive effects on     some variables of the study (mainly, caregiver burden).   "
16594|NCT03068286|"     SilverCloud provides internet-delivered interventions for depression and anxiety in NHS     Mental Health Services. The interventions have proved successful in the management of     depression and anxiety for clients presenting to mental health services, with recovery rates     exceeding the national standard. Recently SilverCloud has embarked on tailoring the     interventions for patients with long-term conditions including COPD, pain and diabetes. The     purpose of the customisation is to make the interventions more meaningful and relevant to     patients with LTCs, but all the while having the same goal of addressing depression and     anxiety disorders. In doing so it would be expected that individuals might be in a better     position to effectively self-manage their LTC. The current study, therefore, seeks to assess     the possible effectiveness of implementing customised internet-delivered interventions for     depression and anxiety for people with long-term conditions presenting to NHS mental health     services.   "
16595|NCT03068273|"     This program will provide patients with type 1 and high risk type 2 diabetes the safest     hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their     glucose parameters in real-time similar to other continuously monitored vital signs. The CGM     will inform a team of health professionals who will monitor the patients' progress,     communicate recommendations, and be available for discussion when recommended targets are not     achieved. Health teams will utilize sensor results in addition to existing electronic medical     records data to evaluate progress and manage care.   "
16596|NCT03068260|"     ECS is a very common procedure. A 1-year retrospective survey revealed a vast opioid     consumption among the new mothers of approximately (mean±SD) 35±25 mg of oral morphine in the     first 24 postoperative hours despite a multimodal analgesic regimen. The adverse effects of     morphine are well known and include postoperative nausea and vomiting (PONV), itching,     fatigue, constipation, confusion, respiratory depression and delayed mobilization. These     adverse effects are unsound for the new mothers as well as the breast-fed, newborn children.     This study aims to evaluate the efficacy of bilateral Transmuscular Quadratus Lumborum (TQL)     block in reducing postoperative morphine consumption and pain.   "
16597|NCT03068247|"     The primary study intent is to examine biological mechanisms associated with acute and     chronic treatment responses in major depressive disorder (MDD). It is hypothesized that     treatment responsiveness, representing endogenous opioid system function, will be associated     with acute improvements in mood state over a 10-week treatment trial in MDD. Potential (bio)     markers of treatment effects will be tested against psychophysical responses to placebo and     active treatments.   "
16598|NCT03068234|"     This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as     treatment of systemic sclerosis. The primary outcome of this study is improvement of skin     fibrosis.   "
16676|NCT03067220|"     To assess if a virtual out patient clinic via a telephone review was an acceptable and safe     alternative to a clinic attendance for a broad range of general surgical patients discharged     following a hospital admission.   "
16952|NCT03063619|"     This randomized phase II trial studies how well afimoxifene works in reducing the risk of     breast cancer in women with mammographically dense breast. Estrogen can cause the growth of     breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking     the use of estrogen by the tumor cells.   "
16599|NCT03068221|"     The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility,     oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women     population. One of the main criteria of this syndrome is a hyper androgenic state.      More than 50% of women who have PCOS are overweight. In the teenage population, PCOS is     common in 5-10% of teenage girls. A recent research has shown that elite athlete teenage     girls have higher serum androgen levels, especially in anaerobic types of sport.      The purpose of this experiment is to examine the reaction of teenage PCOS overweight girls     towards anaerobic exercise. To determine if their hyperandrogenic state is more adapted to     excel in anaerobic exercise compared to teenage overweight girls without PCOS.   "
16600|NCT03068208|"     Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous     amyloidosis treatment in Asians, pilot study.   "
16601|NCT03068195|"     The purpose of this study is to determine whether microwave ablation is more effective in the     treatment of simple renal cysts than conventional laparoscopic decortication.   "
16602|NCT03068182|"     Cardiovascular response to exercise affects the capacity of all body organs depending upon     intensity, duration and mode of exercises. The aim was to compare acute effects of arm crank     with treadmill moderate intensity exercises on heart rate variability in normal participants.   "
16603|NCT03068169|"     Cardiovascular diseases (CVD) are associated with high healthcare costs, as well as are a     leading cause of mortality and hospitalizations. The main challenge for today's researchers     is to develop new technologies, which may help to improve diagnosis of CVD, thereby reducing     healthcare costs and quality of patients' lives. Non-invasive wearable electronics offer new     capabilities for the diagnosis and management of patients with CVD. Several reports with     wearable electronics have been published, in which achieved very positive results with high     accuracy. Aim of our study is to show utility of biomedical shirt-based ECG monitoring of     patients with CVD in different clinical situations using Nuubo® ECG (nECG) system.   "
16604|NCT03068156|"     Efficacy of 308-nm excimer laser for primary localized cutaneous amyloidosis treatment in     Asians, pilot study.   "
16606|NCT03068130|"     This extended access study will assess the long-term safety and tolerability of bardoxolone     methyl in qualified patients with pulmonary hypertension (PH) who previously participated in     controlled clinical studies with bardoxolone methyl.   "
16607|NCT03068117|"     Patients with malignant pleural mesothelioma (MPM) frequently have significant physical     symptoms, with up to 92% of patients complaining of three or more symptoms at presentation.     Such symptom scores are similar to those reported in advanced non small cell lung cancer     (NSCLC) and have been demonstrated to correlate with interference with activity and worse     quality of life (QOL). Several studies have reported that baseline Quality of Life (QOL) is a     significant prognostic factor for survival in NSCLC patients. In 2010, a non-blinded     randomised controlled trial of 151 patients in the United States (US) demonstrated an     improved QOL, fewer depressive symptoms and improved survival with early, regular specialist     palliative care team (SPCT) involvement in addition to their routine care.      The RESPECT-Meso study will examine the effect on quality of life following early Specialist     Palliative Care (SPC) involvement for Regular Early Symptom Control Treatment (RESSCT) in     addition to routine care in patients with newly diagnosed MPM in the United Kingdom (UK).   "
16608|NCT03068104|"     This study aims to estimate the difference between predicted and provided massive transfusion     in adult trauma patients admitted to university hospitals in urban India.   "
16609|NCT03068091|"     The purpose of this study is to determine whether patient with ILD have altered lung     compliance on chest CT before they have macroscopic structural changes on CT.   "
16610|NCT03068078|"     Further studies are needed to establish the optimal diet for treating T2D.      The investigators wishes to investigate whether a low carbohydrate diet, high in     monounsaturated fats (LCD) will affect cardiovascular function, metabolism and the liver.      135 participants with T2D, will be following either a LCD, or a regular diabetes diet (RDD)     for 6 months. Measurements and investigations will be performed at baseline and after 6     months.   "
16611|NCT03068065|"     This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide,     liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.   "
16612|NCT03068052|"     This is an RCT among UPHS employees between ages 50-64 comparing no incentive and a     loss-framed incentive for completing cancer health risk assessment. Those eligible will     receive the phone number for direct colonoscopy scheduling, with the incentive arm receiving     an additional unconditional incentive. The primary outcome is completion of screening     colonoscopy. Secondary outcomes include scheduling of colonoscopy and completion of risk     assessment.   "
16613|NCT03068039|"     Breakfast porridges made from milled grains are commonly eaten worldwide. Traditionally     different grains are used in different countries. For example, oats are more common in the     Anglo-Saxon countries whilst millet is very common in parts of India and Africa. However the     nutritional value of different grains and their potential effects on the body may vary     dramatically: for example the effect on blood sugar, on how fast the stomach empties after     eating and how full people may feel.      RESEARCH QUESTION: The investigators think that a pearl millet breakfast will cause a smaller     rise in blood sugar compared with an oat breakfast containing the same number of calories.     The investigators also think that there will be a difference in how full people feel and how     fast their stomach will empty. These 2 breakfasts will be fed to each one of 26 healthy     volunteers, one week apart. A safe medical imaging method (MRI) will be used to look at how     quickly the breakfast empty from the stomach and how this affects the small bowel. Blood     glucose levels will be measured using a finger prick test (the same as used by diabetics) and     some small blood samples will be taken from a vein in the arm to measure the chemicals     released by the gut after feeding gut hormones.   "
16723|NCT03066648|"     To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with     decitabine in relapsed/refractory AML patients, de novo AML patients who are not candidates     for standard induction therapy, or high risk MDS patients, and to identify recommended doses     for future studies.   "
18217|NCT03047083|"     The purpose of this study is to retrospectively evaluate the treatment patterns and     AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation     status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.   "
16614|NCT03068026|"     People with COPD have more air in their lungs than other people (this problem with high lung     volumes is called hyperinflation). Unfortunately this is unhelpful as breathing at higher     lung volumes requires more effort and contributes to breathlessness. When anyone exercises,     they breathe more quickly. People with COPD have narrowed airways, which makes breathing out     difficult. When they breathe more quickly they may not be able to breathe out fully before     they need to take the next breath in. This means that the volume of air in their lungs tends     to increase further during exercise, which makes breathing even more difficult. This problem     is called dynamic hyperinflation.      Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and     most of the benefit gained is from exercise. Anything that helps people increase the amount     of exercise they can perform should lead to further improvements.      Non-invasive positive pressure ventilation is a method of supporting a person's normal     breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which     helps patients to breathe out more completely. The device also detects when patients start to     breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a     deeper breath in. Previous research studies have shown that when people with COPD use     non-invasive ventilation during exercise they are able to exercise for longer and are less     breathless. The purpose of this study is to assess whether a new portable non-invasive     ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness     during the exercise breaks more quickly (by reducing dynamic hyperinflation, described     above) and to exercise for longer overall. The VitaBreath device is small and light, weighing     0.5 kilograms (just over one pound). It is handheld and battery powered.   "
16615|NCT03068013|"     Background: Patients with advanced cancer suffer from a variety of psycho-social symptoms     that impair quality of life and may benefit from psychotherapeutic treatment. We describe     here the methodology of a randomized controlled trial to test the efficacy of a novel and     brief semi-structured psychotherapeutic intervention, called Managing Cancer and Living     Meaningfully (CALM), originally developed in Canada and now cross-culturally tested in Italy.      Methods/Design: The study is a single-blinded randomized controlled trial with 2 conditions:     CALM intervention versus nonspecific supportive intervention (SPI) and assessments at     baseline, 3 and 6 months. The site is the Program on Psycho-Oncology and Psychiatry in     Palliative Care, University of Ferrara and Integrated Department of Mental Health, S. Anna     University Hospital, in Ferrara, Italy. Eligibility criteria include: ≥ 18 years of age;     Italian fluency; no cognitive impairment; and diagnosis of advanced cancer. The intervention     consists of 12 sessions , following the CALM manual and allowing for flexibility to meet     individual patients' needs. It is delivered over a 3-6-month period and provides reflective     space for patients (and their primary caregivers) to address 4 main domains: symptom     management and communication with health care providers; changes in self and relations with     close others; sense of meaning and purpose; and the future and mortality. The primary outcome     is depression and the primary endpoint is at 3 months. Secondary outcomes include     demoralization, generalized anxiety, death anxiety, spiritual well-being, quality of life,     attachment security, posttraumatic growth, communication with partners, and satisfaction with     clinical interactions.      Discussion: This trial is being conducted to determine the feasibility and benefit of CALM in     an Italian cancer setting. The intervention has potential cross-national relevance and, if     shown to be effective, has the potential to be disseminated as a new approach in oncology to     relieve distress and promote psychological well-being in patients with advanced cancer.   "
16616|NCT03068000|"     There will be a three-month intervention with two groups: judo training and ball games, twice     a week, for 50 minutes. The sample will consist of children and adolescents with low     socioeconomic status, participants of a philanthropic institution, aged between 6 and 15     years, who will be randomized in the two groups mentioned above. Motor skills, physical     fitness, cardiovascular parameters and questionnaire assessing socioeconomic status, quality     of life, physical activity level, screen time, sleep quality, back pain, food intake and body     image dissatisfaction will be evaluated.   "
16617|NCT03067987|"     Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a     unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves     are aimed at the left and right corpora cavernosa and the crura. The study is aimed at     determining the safety and effectiveness of this new type LISW in the relief of erectile     dysfunction.      HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a >2-point increase     in the IIEF-EF score from baseline for mild erectile dysfunction, and >5 points for moderate     erectile dysfunction and will show significant change.      Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment     groups for alleviating erectile dysfunction measured using International Index of Erectile     Function score (IIEF-EF).      Primary Efficacy Objective: To evaluate change of International Index of Erectile Function     score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.      Secondary Objectives:To study sexual activity improvement leading to optimal penetration at     follow-ups according to:        -  SEP- Sexual Encounter Profile Questionnaire.        -  GAQ- Global Assessment Questionnaire.        -  EHS- Erection Hardness Score.   "
16618|NCT03067974|"     The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate     sedation of children undergoing minor procedures in the Emergency Department. An intranasal     dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators     hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation     and analgesia for the physician to successfully complete the planned diagnostic or     therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be     successful sedation, as defined by the ability to complete the planned procedure without     rescue medication, which includes re-dosing of the same medication.   "
16619|NCT03067961|"     Typhoid fever results from infection with a bacterium called Salmonella Typhi and is a major     cause of illness worldwide. It is estimated to infect 20-25 million people every year and can     affect people of all ages, but is particularly common in young children. The disease is     spread through contaminated food and water, and efforts to improve water quality, sanitation     and hygiene will likely go a long way to reducing the global burden of disease.     Unfortunately, improving access to clean water and sanitation improvements is very costly and     difficult to implement on a large scale. Vaccination against typhoid fever is likely to be a     cost-effective way of reducing the global disease burden. There are two vaccines currently     available against typhoid fever. Whilst these vaccines provide some protection against     disease (in the region of 50-70%) these vaccines are less effective in young children, who     are the population group at highest risk of disease. In order to develop a new generation of     typhoid vaccines it is important to have a more complete understanding of how the bacterium     causes disease. In this study, the investigators are aiming to understand more about the     Salmonella Typhi bacteria and how it causes disease. In particular, the investigators aim to     study the importance of a toxin produced by the typhoid bacteria, called the typhoid toxin.     The typhoid toxin has only recently been discovered. It is made only by the typhoid bacteria     and closely related bacteria, such as paratyphoid. From studies done in the laboratory, there     is evidence that the typhoid toxin is important in causing typhoid disease. It is thought     that the typhoid toxin might be important in causing symptoms of typhoid disease, however the     exact role of the typhoid toxin during infection in humans hasn't been studied before.     Studying this might impact on the design new vaccines against typhoid.      In this study, the investigators will be undertaking a 'challenge' with two strains of the     typhoid bacteria (Salmonella Typhi). This involves exposing participants to live Salmonella     Typhi under defined circumstances, by asking them to swallow a solution that contains the     bacteria. After the challenge the investigators closely monitor participants for a period of     at least two weeks and the investigators will then treat participants with antibiotics as     soon as they are diagnosed with typhoid disease. The investigators are interested in     comparing the response to challenge between two strains of the typhoid bacteria that differ     in the production of the typhoid toxin. This process has been undertaken by participants in     previous Oxford Vaccine Group studies since 2011.   "
16752|NCT03066271|"     The aim of this study is to evaluate the feasibility and the effect of daily, individual,     supervised and structured exercise training before radiotherapy in patients diagnosed with     Non-Small Cell Lung Cancer. Primary outcome is maximal oxygen uptake (VO2peak). The     hypotheses are that patients who undergo daily exercise training will increase VO2peak,     functional capacity (measured by 6-minute walk test (6MWD)) and lung function (forced expired     volume in one second (FEV1)).   "
16620|NCT03067948|"     This research is a feasibility pilot of an intervention to respond to positive screening     tests for mental health(MH) and substance use (SU) captured through the Patient Reported     Outcomes questionnaires (PROs). The PROs are currently performed in the clinic, however, the     results are neither reviewed with patients nor transmitted to providers. This pilot assesses     the feasibility of moving the PROs into the clinical realm by having patients review the PRO     results, identifying an issue to discuss at the patient's next HIV primary care visit, and     determining whether this process increases discussion of MH and SU disorders in the     subsequent clinical visit and/or increases referrals to MH and/or SU treatment.   "
16621|NCT03067935|"     Celldex endeavors to make investigational products available to patients with     life-threatening diseases who have exhausted other treatment options and where there is a     reasonable expectation of benefit over risk. Requests for expanded access to glembatumumab     vedotin in patients with gpNMB expressing triple negative breast cancer will be considered.   "
16622|NCT03067922|"     Breast cancer is the most common cancer in women in India and accounts for 27% of all cancers     in women. Incidence rises in early thirties, peaks at 50-64 years. Approximately 48% are     below 50 years of age. Most present when symptoms develop, so are 2B and beyond. Treatment     depends on the stage of the disease. Surgical removal of the tumour is part of the treatment     attempting a cure.      Simple mastectomy involves removal of breast tissue without axillary lymph node dissection or     removal of chest wall muscles. Radical mastectomy involves removal of the entire breast,     skin, pectoralis major and minor muscles and ipsilateral axillary lymph nodes. Modified     radical mastectomy involves removal of the breast and ipsilateral axillary lymph nodes. The     pectoralis muscle is preserved. Breast conserving surgery involves removal of tumour with or     without axillary dissection. The extent of surgery tells us about the nerve damage, local     tissue handling. For example operating in upper and outer quadrant of breast and axilla     increases nerve handling in that particular region. Local radiation also plays a role.      Persistent pain after mastectomy was first reported in the 1970s by Wood and defined by     International Association for Study of Pain (IASP) as pain in the anterior aspect of the     thorax, axilla, and/or upper half of the arm beginning after mastectomy or quadrantectomy and     persisting for more than three months after surgery and known as Postmastectomy pain Syndrome     (PMPS). It is a common problem, with a 25- 60% incidence. The pain is described as burning or     tenderness with paroxysms of lancinating, shock-like pain, and also described by some as     dysesthesia (perception of non noxious stimuli as painful). Risk factors for PMPS include     age, raised Body mass index (BMI), severity of postoperative pain, type of surgery,     susceptibility to pain with a history of other pains such as headache and dysmenorrhoea.     Axillary hematoma and postoperative radiotherapy have also been implicated in the development     of PMPS.      Tata Memorial Hospital, is a tertiary cancer institute in India. Around 4000 patients with     suspected breast cancers register annually at the hospital and approximately 2800 breast     cancer surgeries are performed yearly. Very few studies on PMPS in Indian population exist.     We therefore plan to identify the incidence of PMPS in our patients and also the severity of     pain along with its impact on daily function and quality of life   "
16623|NCT03067909|"     Hundreds of thousands patients undergo implantation or replacement of cardiac implantable     electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive     antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of     developing pocket hematoma which in turn is associated with an increased risk of potentially     fatal device-related infections when clinically significant. Aim of the registry is to     retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national     registry in Italy) investigate the different strategies for the management of antithrombotic     therapy and the related complication rates (1-month and 12-months) in patients undergoing     CIED surgery in a real-world setting. The registry will also provide data on the economic     impact of different management strategies and complications.   "
16624|NCT03067896|"     Regional anesthesia has become more popular in cesarean deliveries because most of the     parturients prefer being awake during the birth process. In addition, regional anesthesia may     be a safer method than general. In spinal anesthesia local anesthetics alone may not be     enough for an effective postoperative analgesia and hemodynamic stability of the patient wich     is crucial during cesarean section. So far many adjuvants have been used to augment the     analgesia produced by intrathecal local anesthetics and to reduce their adverse effects .      Various intrathecal adjuvants to local anaesthetics have found to improve the quality and     extend duration of spinal block. Prolongation of duration of spinal block is desirable both     for long procedures and for postoperative pain relief. Efficacy and safty of intrathecal     magnesium as analgesic adjuvant has been tested by several clinical trails in recent     years.Antinociceptive effect of magnesium appears to be relevant for the management of     chronic and post operative pain. These effects are primarily based on regulation of calcium     influx in to the cell. Magnesium blocks calcium influx and non competitively antagonizes NMDA     channels. NMDA receptor signelling plays an impartent in determining the duration of acute     pain3).) addition of magnesium to spinal anaesthesia improved postoperative analgesia in     orthopedic setting. addition of intrathecal magnesium sulfate to 10 mg bupivacaine plus 25µg     fentanyl prolonged spinal anaesthesia in patients undergoing lower extremity surgery.      Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as     pre-medication and as an adjuvant to general anesthesia.Dexmedetomidine have several     beneficial actions during perioperative period. They decrease sympathetic tone with     attenuation of the neuroendocrine and haemodynamic response to anaesthesia and surgery,     reduce anaesthetic and opiod requirement, cause sedation and analgesia. Dexmedetomidine was     first introduced into clinical practice as a short term intravenous sedative in intensive     care. Like any other adjuvant dexmedetomidine is not free from adverse effects. Use of     dexmedetomidine is often associated with a decrease in heart rate and blood     pressure.Dexmedetomidine was used to enhance the analgesic property of local anaesthetics     like lidocaine bupivacaine and ropivacaine. In vivo and in vitro studies indicated that these     local anaesthetics had significant neurotoxicity. Dexmedetomidine showed protective or growth     promoting properties in tissues, including nerve cells from cortex. Intrathecal     dexmedetomidine has a neuroprotective effect similar to methylprednisolone.      The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory     block of local anesthetics is not clear. It may be an additive or synergistic effect     secondary to the different mechanisms of action of local anesthetic and alpha 2 adrenergic     agonist. The local anesthetics act by blocking sodium channels, whereas the alpha 2     adrenergic agonist acts by binding to pre synapyic C fibre and post synaptic dorsal horn     neurons. Intrathecal alpha 2 adrenergic agonist produce analgesia by depressing the realease     of C fibre transmission by hyperpolarization of post synaptic dorsal horn neurons. Li et al     observed that Glutamate is involved in excitatory neurotransmission nociception and plays an     essential role in relaying noxious stimuli in the spinal cord. Intrathecal injection of alpha     2 adrenergic agonists produces potent antinociceptive effects by altering spinal     neurotransmitter release and effectively treats acute pain.   "
16628|NCT03067844|"     Coronary artery disease (CAD) is the most frequent cause of mortality in the industrialized     world. Hypercholesterolemia is a major risk factor for the development and progression of     CAD. While statins currently represent the first-line, gold-standard therapy for primary and     secondary prevention of cardiovascular morbidity and mortality, nearly 50% of patients in     Europe and Canada treated with statins do not achieve their target levels of low-density     lipoprotein cholesterol (LDL-C) or cannot tolerate effective statin doses.      Recently, a growing number of studies of PCSK9 inhibitors in a wide spectrum of patients with     hyperlipidemia on or off lipid-lowering therapy, familial hypercholesterolemia, and statin     intolerance demonstrated consistent, profound, and sustained reductions in LDL-C with greater     magnitude of reduction as compared with high-dose statin regimens. However, the effects of     PCSK9 inhibition on coronary plaque morphology remain unknown.      This study will investigate the effect of the PCSK9 inhibitor alirocumab in patients with     acute myocardial infarction undergoing percutaneous coronary intervention (PCI) in the     infarct-related artery and receiving guideline-recommended high-intensity statin therapy. A     serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical     coherence tomography imaging study will be performed to determine the change in plaque volume     at week 52. A total of 220 patients will be enrolled in the study and randomized in a 1:1     ratio to either alirocumab or placebo.   "
16629|NCT03067831|"     This study is single arm, single center trial to study the safety and efficacy of bone     marrow-derived autologous specific populations of stem cells and mesenchymal stem cells for     the treatment of Duchenne Muscular Dystrophy (DMD).   "
16630|NCT03067818|"     This study examines the effect of non-invasive brain stimulation targeting different brain     areas on movement of the affected arm post-stroke. Participants will receive stimulation to     each of 3 different brain areas combined with a session of arm exercise.   "
16631|NCT03067805|"     The aim is to evoke romantic jealousy between couples and investigate whether oxytocin has     effect on it.   "
16632|NCT03067792|"     Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy.      Palliative chemotherapy had proven to be better overall survivals and quality of life in     unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic     regimen as a first line therapy. But response rate of those regimens is about 50 percent.     Disappointingly most of cases are about to experience progression of disease.      Second line regimens of palliative chemotherapy are also have shown its efficacy and     recommended within patients with better performance status. But There is still lack of     evidences in gastric cancer patients second line chemotherapy. Several phase II trial those     subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that     irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in     combination with paclitaxel would increase response rate in patient previously treated for     advanced gastric cancer compared with FOFIRI regimen.   "
16633|NCT03067779|"     This study is looking to improve the safety of patients with chronic kidney disease via     education provided on a mobile tablet. This study will additionally examine if electronic     tools, such as mobile tablets, can help.   "
16636|NCT03067740|"     Fifty two children of American Society of Anesthesiologists (ASA) physical status I and II,     aged 8-14 years old, of both gender, with suspected acute appendicitis scheduled for     laparoscopic appendicectomy, were included in this study. Patients were randomized into group     (B) and group (BD) with a 1:1 allocation ratio.At the end of surgery, and after peritoneal     lavage, those patients who were allocated to B group (bupivacaine group; n = 26) received     bupivacaine 0.25% intraperitoneally at a dose of 2 mg/kg followed by 5 ml normal saline.     However, in group BD (bupivacaine, Dexmedetomidine group; n = 26), bupivacaine 0.25% at a     dose of 2mg/kg was instilled intraperitoneally followed by dexmedetomidine 1mcg/kg diluted in     5 ml normal saline. In the postoperative period, assessments were made for pain and sedation     on awakening in PACU (0 time) and at 2, 4, 6, 12,and 24 h. Abdominal and/or shoulder pain was     assessed on the 10-cm Visual Analog Scale (VAS). Sedation was assessed using the Ramsay     sedation score. Also the occurrence of nausea or vomiting was recorded . The time from     extubation to the first administration of pethidine was registered. The consumption of     postoperative analgesia was recorded. Side effects of the study drugs were assessed and     recorded by the ward nurses for 24h postoperatively. Possible complications such as     respiratory depression, allergic reactions, local anaesthetic toxicity,dizziness, , headache,     were recorded and managed accordingly. Duration of surgery and length of stay in PACU were     noted. Before discharge to home, length of stay in the hospital was recorded and parent's     satisfaction was assessed using the 7‑point Likert scale   "
16637|NCT03067727|"     To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening     success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert     administration   "
16664|NCT03067376|"     The study was designed to evaluate how CORT125134 is taken up, broken down and removed from     the body when given as an oral capsule to healthy subjects.   "
16665|NCT03067363|"     This is the first in human study of MOR107. It is a 2 part, single centre, double-blind,     randomised, placebo-controlled study in healthy male subjects. Part 1 is a single ascending     dose study, and Part 2 is a parallel group, dose range finding study in healthy male subjects     on a low sodium diet.   "
17342|NCT03058536|"     The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal     progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve     perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.   "
16638|NCT03067714|"     With the rising prevalence of allergic diseases and the subsequent risk of developing other     immune-related disorders, primary prevention of allergy has become a major priority. It is     generally acknowledged that breastfeeding is one of the main pillars in allergy prevention.     Infant formulas based on hydrolysed proteins have been developed to be used by infants at     increased risk of developing allergy in case a mother is unable or chooses not to breastfeed     her infant. It has recently been demonstrated that the gut microbiota composition and     microbiota activity of infants receiving an infant formula based on partially hydrolysed     proteins, supplemented with oligosaccharides, is more similar to breastfed infants than to     infants receiving standard cow's milk formula, demonstrated by increased levels of     bifidobacteria. However the interaction between microbial changes impacted by an     hypoallergenic concept and its influence on early life immune development should be further     explored. The aim of the present study is therefore to investigate the bifidogenic effect of     a hypoallergenic formula supplemented with prebiotics and probiotics compared to standard     infant formula in infants at increased risk of developing allergic disease. This study will     secondary assess the effects of this concept on the development of allergic manifestations up     to the age of 12 months, which will be verified in a separate clinical study MAESTRO as     primary outcome. Furthermore, the effects on growth and safety will be studied.   "
16639|NCT03067701|"     In healthy young adults 18-39 years of age, the investigators will determine if intermittent     inhalation a 0.1% CO, from a 1-liter bag once every minute for 30-40 minutes, at a level that     approaches the CO boost with hookah smoking, augments endothelial function, thus implicating     CO as the major endothelial vasodilator substance in hookah smoke.      Rationale: Our group has demonstrated (PRO36547) that in contrast to cigarette smoking,     hookah smoking (tobacco heated with charcoal) acutely augments, rather than impairs, brachial     artery FMD. Importantly, our data strongly implicate—but do not prove—that the augmentation     in FMD is caused by CO. Therefore; the investigators would like to extend the scientific     priority of this work by directly investigating cause and effect of CO breathing (similar     levels than ones obtained after hookah smoking) on brachial artery FMD.   "
16640|NCT03067688|"     Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy     and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with     hypertension and hyperlipidemia.   "
16641|NCT03067675|"     The objective of this study is to collect OCT measurement data on normal healthy eyes.   "
16642|NCT03067662|"     A few, small randomized controlled trials have investigated the effects of exercise on blood     glucose levels in women with gestational diabetes (GDM), with inconsistent results.      To assess the effects of supervised exercise in women with GDM, 48 women with gestational     diabetes, diagnosed between the 18th and 28th week of gestation, will be recruited, after     exclusion of subjects with contraindications to exercise. These subjects will be randomly     assigned to two groups: structured exercise intervention or standard care.      Women in the intervention group will perform low intensity aerobic exercise three times per     week at 30% HRR (heart rate reserve), under continuous heart rate monitoring. Duration of     each session will progress from 26 minutes the first week to 40 minutes (increasing 2     min/week). Women in the control group will receive standard diet and physical exercise     recommendations.      In all women, clinical, metabolic and anthropometric features will be assessed before, during     and at the end of the study. Newborn data will also be collected.   "
16643|NCT03067649|"     The primary purpose of this study was to test whether conducting a brief motivational     interview that focused on perceived barriers to treatment seeking would increase the     likelihood that a parent with psychiatric problems would seek treatment for themselves.   "
16953|NCT03063606|"     This study will test the effectiveness of cognitive-behavioral therapy as a specialist     treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test     of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments     on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no     additional behavioral treatment .   "
16644|NCT03067636|"     Following the realisation that many aspects of the way we live our life, such as our diet,     activity levels, and amount of screen time, can have a potent impact on mental health and     brain functioning 'lifestyle' based interventions have become topical in medical research. In     particular, much scientific attention has been devoted to the impact of physical exercise and     various stress reduction techniques on mood disorders. We aim to extend this work and     investigate their impact on compulsivity.      We will do this by conducting a pilot proof-of-principal intervention study. The study will     compare the impact of eight-weeks of:        1. regular physical exercise + stress management activity A,        2. regular physical exercise + stress management activity B,        3. lifestyle as usual.      The participant cohort will be adults who endorse mild-moderate behavioural compulsivity on     one of the following domains:        -  drinking alcohol        -  gambling        -  eating        -  washing or cleaning        -  checking        -  ordering or arranging objects   "
16645|NCT03067623|"     The goal of this interventional study is to evaluate the increasing in endometrial thickening     after the intrauterine infusion of 0,5-1 ml of autologous Platelet-Rich Plasma (PRP) and the     implantation rate in women with thin endometrium undergoing Embryo-transfer, in order to     propose a novel therapeutic approach for women with an endometrium < 7 mm unresponsive to     standard treatments.   "
16646|NCT03067610|"     Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either     cisplatin, cetuximab, or carboplatin-paclitaxel)   "
16647|NCT03067597|"     To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for     cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours     of vaginal insert administration.   "
16648|NCT03067584|"     Familial aggregation is well recognized in some cancers. Though a number of familial cancer     predisposition syndromes have been described, the nature of inherited genetic alterations in     patients with a strong history of familial cancer is currently unknown, as is the case with     childhood acute lymphoblastic leukemia (ALL).      The investigators are seeking to learn more about what causes leukemia and why some people     and families may be at a higher risk of developing this disease. By understanding the origin     of the disease, better treatments may be identified for patients with leukemia.      PRIMARY OBJECTIVE: To identify variants in genes that are inherited, have altered gene     structure and/or function, and influence the risk of developing acute lymphoblastic leukemia     (ALL) and other cancers.      SECONDARY OBJECTIVE: To collect demographic, clinical and laboratory information including     detailed family cancer history and response of cancers to therapy for correlation with the     primary objective.   "
16650|NCT03067558|"     Pneumonia is the leading infectious cause of death among children under 5 years of age     globally. Many pneumonia deaths result from late care seeking and inappropriate treatment due     to misdiagnosis of symptoms. The United Nations Children's Fund's (UNICEF's) Acute     Respiratory Infection Diagnostic Aids (ARIDA) project aims to introduce automated respiratory     rate (RR) counting aids for use by frontline health workers in resource limited community     settings and health facilities. These RR counting aids aim to offer improved accuracy,     effectiveness and acceptability compared to current practices for counting and classifying RR     to detect fast breathing pneumonia.      The general aim of the controlled accuracy study is to understand whether the ARIDA test     device accurately measures RR in children under 5 years of age with cough and/or difficult     breathing. It is a cross-sectional, prospective study in a controlled setting comprising     three types of device evaluations:        1. The accuracy of the ARIDA test device in measuring RR in young infants 0 to <2months,          children 2 to <12 months and 12 to 59 months when compared to a video panel reference          standard will be established through the first evaluation.        2. The consistency of the ARIDA test device will be established by determining the level of          agreement between the measures of RR for two ARIDA test devices when used on the same          child at the same time in those aged 2 to <12 months and 12 to 59 months through the          second evaluation.        3. A third evaluation on a different group of normal-breathing children aged 2 to 59 months          will assess RR fluctuation over time due to ARIDA test device attachment.      Evaluations 1 and 2 for accuracy and consistency will also be undertaken with expert     clinicians (EC) conducting a manual RR count to further the evidence base around the     performance of current standard practice in a controlled setting.      The study is a cross-sectional, prospective study and will be conducted in paediatric in and     outpatient departments Saint Paul's Hospital and Millennium Medical Collage in Addis Ababa,     Ethiopia.   "
16651|NCT03067545|"     This project aims to investigate whether an increase in step rate can be used to reduce pain     and injury causing movement patterns in runners who are currently experiencing achilles     tendonopathy, iliotibial band syndrome, patellofemoral pain syndrome and medial tibial stress     syndrome.      Many injuries have been reported to share similar injury causing movement patterns. For     example iliotibial band syndrome and patellofemoral pain syndrome have been reported to be     caused by increased side to side drop of the pelvis and inward movement of the hip.      Gait retraining is a method of changing the way people run in order to change movement     patterns.Increasing step rate may present a gait retraining method that does not pose further     injury risks and can be used across multiple different injury populations. Studies have shown     increasing step rate can reduce frontal plane movement patterns at the pelvis, hip and foot     as well as reducing sagittal plane joint angles such as ankle dorsiflexion. Based on the     changes in movement patterns increasing step rate has been recommended as an intervention for     the treatment of patellofemoral pain syndrome, medial tibial stress syndrome, iliotibial band     syndrome and achilles tendonopathy. Therefore this study aims to investigate whether an     increase in step rate can reduce pain and change injury causing mechanics in runners     currently running with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial     stress syndrome or achilles tendinopathy.      The aim of the project is to use a simple gait intervention, increasing step rate to     investigate if this technique change can reduce pain immediately, at short term follow up and     long term follow up. The project will also look at whether an increased step rate can be     maintained at follow up and whether this changes movement patterns proposed to be the cause     of injury.      Runners will be recruited from local running clubs and competitions using poster     advertisement at running clubs and emailed to running clubs   "
16652|NCT03067532|"     To overcome the obstacles of endoscopic surgery, the da vinci surgical robot system was     applied to the various surgery area . And the complete understanding and practice of the     robotic system is very important condition for successful robotic surgery.      Investigator developed a home made robotic surgery simulator for novice robotic surgeons. And     investigator want to study about the ability of home made robotic surgery simulator versus     existing robotic simulation system.   "
16653|NCT03067519|"     Fast Track Surgery (FTS) was started in colorectal surgery, but was later applied to other     surgical fields. Core elements include epidural or regional anaesthesia, perioperative fluid     management, minimally invasive surgical techniques, pain control, and early mobilization and     feeding. Beneficial effects of FTS include reduced costs, early hospital discharge, and     increased availability of hospital beds.The main aim of this study was to explore the     efficacy of FTS in the Rwandan surgical setting and to demonstrate the benefits of FTS.      it is study comparing the management of surgical patients using traditional management and     fast track surgery. the study was done on patients undergoing elective abdominal surgery only   "
16654|NCT03067506|"     The purpose of this study is to evaluate feasibility and compliance with a novel method for     assessing mood and cognition in participants with major depressive disorder (MDD).   "
16655|NCT03067493|"     RAMEC is a phase II, multi-center, randomized trial with a safety test. There will be a     safety test to establish the safety and tolerability of Neo-MASCT treatment and assess the     immune response to the treatment.The randomized trial will assess DFS and immune response.   "
16658|NCT03067454|"     Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with     operation. With minimal displacement this fracture is usually treated with immobilisation or     early mobilisation. With appreciable displacement especially any malrotation the patient     usually is treated with an operation. This usually includes an open reduction of the fracture     and fixation with plates and screws or just screws. Even if this is an standard procedure     both mild and severe complications have been reported. New studies have shown that even     displaced fractures can be treated with early mobilization. In those cases the fractures may     heal with some shortening but very good function. An advantage of early mobilization is that     the patient avoids the risk of an operation and the costs for the treatment are decreased     markedly. The study is designed to answer the question if early mobilization is not inferior     to operative treatment but with lower costs and without any operation related risks.   "
16659|NCT03067441|"     The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated     in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately     controlled by their current therapy.   "
16660|NCT03067428|"     Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem as it can lead to end     stage liver failure and cardiovascular complications. Diet play an important role in the     development of NAFLD. Many studies have addressed the effects of added fructose on NAFLD. To     date, little attention has been paid to the effects of a diet devoid of fructose. Therefore,     the investigators aim to study the effects of fructose restriction on hepatic fat     accumulation and vascular function using a double-blind randomized placebo-controlled design.   "
16661|NCT03067415|"     Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once     daily.   "
16662|NCT03067402|"     The ROSSTAR trial is a pragmatic trial that will directly compare the strategies of routine     and selective stress imaging testing (with radionuclide imaging (RNI)) late after PCI or CABG     in asymptomatic patients. The study will be a single center trial based at the Jewish General     Hospital (JGH), a McGill University teaching hospital (Montreal, Quebec). A total of 1100     patients who are either >5 years post-CABG or >2 years post-PCI will be randomized. Half of     the patients will be randomized to a routine RNI testing, and the other half to selective RNI     testing.   "
16667|NCT03067337|"     Introduction and Research Problem:      The aim of this project is to evaluate and compare two full coronal restorations on primary     posterior molars over a period of 3, 6 and 12 months in terms of restoration failure,     marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The     restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).      Materials and Methods:      Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who     need restorations will be screened for inclusion criteria till 120 teeth are recruited (60     teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used     to ensure equalizing variables for both groups, each patient will have side restored with SSC     and the opposite side will be restored with Nu/ZR crowns.      Randomization will be done using Statistical Package for the Social Sciences (SPSS) software     version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for     each age group separately with a uniform random variable generation. A simple descriptive     statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used.     Level of significance will be set at (α = 0.05) and level of confidence at (95%).   "
16668|NCT03067324|"     Islet quality control after pancreatic islets isolation process is insufficient. The Islet     Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of     islet graft based on measurement of islet membrane electric potential.   "
16669|NCT03067311|"     To test the feasibility of a clinical trial implementing I-CAT, a novel therapeutic     intervention combining strategies to improve stress reactivity and increase meaningful     coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of     stress reactivity, symptom severity) and distal measures (function, relapse, quality of life)     for 40 people with first episode psychosis in the context of a small randomized controlled     trial.   "
16670|NCT03067298|"     Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine     fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are     called Great Obstetrical Syndromes. Algorithms to predict those outcomes have been     developed by combining maternal characteristics (history, age, BMI, blood pressure),     biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of     placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another     prospective observational study (PREDICTION study NCT 02189148) is also ongoing, which aims     to validate those algorithms at the first trimester of pregnancy.      Recent data suggest that repeating the same measurements later in pregnancy could improve the     detection rates, allowing closer monitoring of high-risk patients and potential therapeutics     under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and     aims at validating the use of these markers in a combined iterative manner in the prediction     of preeclampsia and other obstetrical outcomes.   "
16671|NCT03067285|"     A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate     HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and     who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be     related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the     combination of ELV/COBI/FTC/TAF.   "
16672|NCT03067272|"     Prospective, multi-center, pilot study to evaluate the safety of the FemBloc™ Permanent     Contraceptive System for female sterilization in preventing pregnancy.   "
16673|NCT03067259|"     The objective of this study will be to estimate the incidence of postoperative cognitive     dysfunction (DCPO) in patients over 65 years of age, undergoing surgical / anesthetic     procedures and in patients who will not undergo surgical / anesthetic. The patients will be     taken from the Hospital Italiano de Buenos Aires.   "
16674|NCT03067246|"     A study comparing two second generation supraglottic Airway devices, the VBM intubating     laryngeal tube and the I-Gel.   "
16675|NCT03067233|"     To develop and validate a reliable automatic analysis of the signals recorded during a     polysomnography.   "
16677|NCT03067207|"     This study will seek to compare the effect of a mindfulness meditation program for     adolescents with chronic illness delivered either in person or via an online platform. The     8-week program will combine meditation practices, breathing exercises and group discussions.     Participants will be recruited from different general and specialized clinics at the Hospital     for Sick Children and will be allocated to either an in-person or the online group through a     random process (like tossing a coin). The study will aim to recruit 60 participants ages     13-18. Each participant will provide data through research questionnaires, recorded     interviews and saliva samples.   "
16678|NCT03067194|"     The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand     osteoarthritis patients.   "
16679|NCT03067181|"     This partially randomized phase III trial studies how well active surveillance, bleomycin,     carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ     cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell     tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin,     carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading.   "
16680|NCT03067168|"     To determine if levator muscle block with bupivacaine improves postoperative pain control     relative to placebo controls among women undergoing prolapse surgery involving a posterior     colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten     point numerical pain scale.   "
16690|NCT03067038|"     Laparoscopic cholecystectomy (LC) became the standard treatment for symptomatic gallbladder     disease. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing     the invasiveness of conventional laparoscopy. The aim of this study was to compare the     clinical outcome of single-incision laparoscopic cholecystectomy (SILC) with three port     laparoscopic cholecystectomy (TPLC).   "
18269|NCT03046407|"     This project intends to transplant human embryonic stem cells derived retinal pigment     epitheliums into subretinal space of patients to treat dry age-related macular     degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat     dry AMD.   "
16681|NCT03067155|"     Viral infections remain an important cause of morbidity and mortality after allogeneic stem     cell transplantation (SCT), especially after myelo-ablative conditioning and if the donor is     antigen-mismatched or haplo-identical.. In the described setting the patient's own immune     system has been destroyed by the necessary highly immuno- and myelo-ablative conditioning and     all memory against infections has been deleted. Therefore, there is a high risk for several     viral infections and other infectious organisms.Both primary viral infections and     reactivations can occur, and patients can become refractory to antiviral treatments, or in     some cases an adequate antiviral treatment is unavailable or too toxic. In this study, the     investigators will target CMV, as refractory CMV infection and disease is accompanied by an     extremely high mortality rate and therefore the development of new treatment approaches is     required. Despite the available antiviral drugs, a considerable number of patients are facing     an insufficient control of CMV reactivation after SCT. Because reconstitution of CMV-specific     T cells confer protection against the development of CMV disease after SCT, attempts have     been made to restore antiviral immunity by direct infusion of CMV-specific T cells. Most     clinical cellular immunotherapy protocols for CMV treatment have used CMV-specific cytotoxic     CD8+ T-cell lines generated by repetitive in vitro stimulation with CMV antigens with     success. Despite the proven efficacy, use of cellular therapy in the clinic has been limited,     because the approach is time and labor consuming and requires specialized facility allowing     handling of the therapeutic cells according to good manufacturing practice. In addition, no     sustained response was seen after adoptive transfer that involved only cytotoxic CD8+ T     cells. This phenomenon is supported by the fact that recall responses to latent infections     depend on the presence of CD4+ T cells to help cytotoxic CD8+ T cells. An alternative     approach for the transfer of T-cell immunity is the isolation of Ag-specific T cells ex vivo     from the blood of CMV seropositive donors, based on interferon γ (IFN-γ) secretion of T cells     after in vitro stimulation with viral Ag, resulting in a combination of CD4+ T helper and     cytotoxic CD8+ CMV specific T cells. Using this strategy, a short-term ex vivo protocol was     developed for the isolation of pp65 (CMV immunodominant protein)-specific T cells. Since     then, several centers have used this protocol in the clinic, infusing low numbers of     pp65-specific T cells, that were able to restore protective T-cell immunity against CMV in a     post SCT setting in patients with refractory CMV disease or viremia. For this protocol the     investigators have set up and validated this method of CMV-specific T-cell generation in the     Ghent University Hospital and the investigators will make it available for other Belgian     transplant centers.   "
16682|NCT03067142|"     The purpose of this study is to identify unique urine protein markers of Primary     Hyperoxaluria type 1 (PH1) compared to healthy controls. Urine protein markers can be     identified by proteomic analyses in which proteins are processed in a lab to break them     down into smaller building blocks. Using analytical chemistry techniques and specialized     equipment many proteins can be identified and measured. Most proteins are found in healthy     living cells while subtle changes in these proteins or the presence of different markers     reflect abnormal processes and patterns of disease. When identified in disease, protein     biomarkers can help to determine if a disease responds to new types of therapies. In this     study, changes in urine proteomic patterns over time, their association with change in     estimated (calculated) kidney filtering function, and the relative risk for progression of     PH1 will be determined. Additionally, as part of the study, the investigators will measure     urinary proteins and peptides that are markers of kidney tissue protection (for healthy     healing of the kidneys from ongoing damage from high urine oxalate levels, oxalate crystals     and stones) to establish if and when these markers are prospectively decreased in PH1 urine.     Longitudinal studies of urine proteomics may assist in identifying the mechanisms behind     PH1-related progression of kidney failure and might contribute important information towards     future identification and development of effective therapies to slow or prevent kidney     failure in PH1.   "
16683|NCT03067129|"     An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir     (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to     < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be     enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age     group and the remainder of participants will be enrolled for the evaluation of safety and     efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment,     based on available PK and clinical data to achieve therapeutic exposures that have been safe     and efficacious in adults.      Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include     participants who are in 12 to < 18 years of age who can swallow the adult formulation of     GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into     Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of     GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their     hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.   "
16684|NCT03067116|"     Determine balance changes during pregnancy   "
16966|NCT03063437|"     The objective of this study is to provide preliminary insight into the safety and efficacy of     fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of     vancomycin-resistant Enterococcus.   "
16685|NCT03067103|"     Adenotonsillectomy is one of the most common ambulatory surgical procedures performed to     children. Tonsillectomy or adenotonsillectomy have a high incidence of postoperative pain.     There is still debate about the optimal analgesia for this common surgical procedure.     Different methods have been described and used to reduce pain including; improved     intraoperative anesthetic pain regimens, use of corticosteroids, adjustment of surgical     technique, and intraoperative local anesthetic injection. Intraoperative local anesthetic is     a preventive or preemptive analgesia which is the analgesia given before painful stimuli to     prevent the subsequent pain. The main goal of the preventive analgesia is the pain relief     with minimum side effects. The role of local anesthetic infiltration in the reduction of     postadenotonsillectomy pain is still controversial. The objective of this study is to     investigate and compare the effectiveness of preincisional peritonsillar infiltration of     ketamine and tramadol for post-operative pain on children following adenotonsillectomy. This     is prospective, double-blinded randomized study.   "
16686|NCT03067090|"     Osteoarthritis (OA) causes degradation and deformities of joints, including knees, hips,     hands, and feet. Approximately more than 55% of populations above 45 years and more than 70%     of population above 70 years will develop OA in at least one joint. The symptoms are     dominated by pain but also stiffness and swelling occur. There is currently no cure for OA,     and the ultimate treatment is joint replacement surgery. However, there is an unmet need to     identify other treatment options that may delay or avoid surgery.      Aquamid Reconstruction (AR) is a polyacrylamide hydrogel (PAAG) which is a non-degradable,     highly visco-elastic synthetic gel, which is atoxic with durable effect and     tissue-compatibility and well tolerated by mammal tissue by allowing in vivo vessel and     fibrous in-growth. Experimental studies supported by histopathological observations have     shown that AR exerts its effect via integration over time within the soft tissues, through a     combination of vessel in-growth and molecular water exchange. Intra-articular injection of AR     is expected to provide permanent pain relief and improve the functional ability through a     cushioning or padding effect on the joint and thereby reduce symptoms and improve patients'     quality of life.      The purpose of this study is to obtain information of the safety and effectiveness of AR in     patients with OA of the knee.   "
16687|NCT03067077|"     Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to     correct myopia.   "
16691|NCT03067025|"     Most youth with MS experience symptoms such as depression and fatigue. In addition, cognitive     issues, especially with attention and memory occur frequently. However, little is known about     interventions that might work to improve these symptoms. In other work. the investigators     have shown that higher levels of physical activity are associated with lower levels of     depression and fatigue. Importantly, sleep problems are frequently encountered in youth with     MS, and were seen in 60% of surveyed youth with MS in the investigators preliminary work.     Whether sleep plays an important role in symptoms in youth with MS, and the relationship     between sleep and physical activity in youth with MS is unknown.   "
16692|NCT03067012|"     The metabolic effect of oncometabolic surgery (long limb Roux-en Y reconstruction) for early     gastric cancer patients has been revealed in a few pilot studies. However, the nutritional     safety has not been dealt with in previous literatures. This is a prospective pilot study for     evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese     early gastric cancer patients.   "
16693|NCT03066999|"     The Center for Disease Control and Prevention (CDC) reports that one in four patients     hospitalized in the United States is catheterized to void the bladder or monitor urinary     output. In the male population, Dr. Singh, an urologist estimates that about 20% of     catheterizations are difficult. Driving a catheter blindly, guessing whether to push the     catheter forward or manipulate it to get around a point of resistance leads to the risk of     injury which increases the more the catheter is manipulated. Additional adverse events     include: urosepsis, UTI and bladder perforation. The standard of care treatment for patients     with difficult urinary catheterization (DUC) is to proceed with a cystoscopic catheter     placement or suprapubic tube placement.      PercuVision has the only Foley catheter with a micro-endoscope for visualization and     navigation of the urethra for nurses and other qualified health care professionals. Moreover,     it allows urologists to place a guidewire under direct vision rather than calling for a     flexible cystoscope which is considered a minor procedure.      In this study, the investigators plan on assessing the effectiveness and ease of use of the     PercuVision DirectVision® System device.   "
16694|NCT03066986|"     The purpose of this study is to assess the potential use of delta-inulin as an adjuvant to     facilitate the desired immune response to Jack Jumper Ant (JJA) venom with a lower dose of     venom, thus reducing adverse reactions, venom requirements and costs of treatment.     Specifically we aim to compare outcomes of in-hospital JJA sting challenges and JJA venom     specific IgE, and IgG4 responses to semi-rush JJA VIT at maintenance doses of 25 and 50 mcg     of JJA venom, with and without delta-inulin adjuvant.   "
16695|NCT03066973|"     This study aimed to assess the efficacy of breathing exercises (BE) during the second stage     of labor for maternal pain, duration of labor and first-minute APGAR score. This is a     randomized controlled trial that compares nulliparous pregnant in the second stage of labor     instructed regarding BE with a control group (CG) that received standard care service. It was     conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum.     One session of BE training were given to pregnant in intervention group (IG). Visual Analog     Scale (VAS) was performed to identify perception of pain to all pregnant during the second     stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR     scores were recorded. Significance was set at p<0.05.   "
16696|NCT03066960|"     The researchers are planning a two-center double blind, sham-controlled randomized trial (N:     44) to assess the long term efficacy of RF neurotomy of cervical medial branches. Patients     with chronic neck pain who are found eligible and achieve >75% pain relief to predictive test     blocks, can be included. Demographic and clinical data will be recorded at baseline while     primary and secondary outcome measurements are recollected after 3, 6, 9 and 12 months.     Primary outcome measurements include self reported neck function (NDI) and pain relief.     Regression analyses will be used to identify how >75% pain relief of a two blocks predicts     response to RF neurotomy.   "
18218|NCT03047070|"     Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known     that bleeding during FESS can affect directly to the visibility of safe landmarks and     surgical outcomes.   "
16697|NCT03066947|"     This is a single arm, open label study of BriaVax™, a targeted immunotherapy for breast     cancer. Eligible patients will have histological confirmation of breast cancer with recurrent     and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose     cyclophosphamide 2-3 days before the vaccination; inoculation of the vaccine in 4 sites on     the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the     sites of vaccination ~2 and 4 days after the vaccination. These is repeated every 2 weeks for     one month (3 treatments), then monthly for up to one year. Standard tumor assessments are     performed at baseline and then every 3 months.   "
16698|NCT03066934|"     Noninvasive ventilation (NIV) is an alternative form of ventilatory support in critical care     encompassing different modes of ventilation such as continuous positive airway pressure     (CPAP), bilevel positive airway pressure (BiPAP) and high flow nasal cannula ventilation.     Although numerous studies on adults exit in literature, the aspects of this ventilatory     support is limited in pediatric age groups. Early recognition of respiratory failure and     initiation of NIV in a pediatric patient would positively affect prognosis by avoiding     certain complications of endotracheal intubation and mechanical ventilation and adds certain     advantages. Decreasing re-intubation rates for the ones who are extubated but necessitating     further oxygen support is another advantage of NIV. Although numerous studies on adults exit     in literature, the aspects of this ventilatory support is limited in pediatric age groups.     Besides, success as well as failure and complication rates in pediatric age groups vary     extensively. This multi-centered, prospective cohort study is planned to observe the     epidemiologic perspectives of study group within underlying problems, success rates between     different age groups, complication and re-intubation rates and finally its' effect on     prognosis and long term survival in a year period. Hence we believe results of this study     would allow us to improve our knowledge on using this technique, applying different modes and     parameters appropriately and design criteria to guide clinician in deciding which group of     patients would benefit from NIV techniques.   "
16709|NCT03066791|"     A noticeably increasing number of patients are asking for naturally based extracts and     ingredients as supplementary dermatologic remedies. Patients are seeking natural and     cost-effective skin care alternatives in place of prescription medications and procedures.     Our study will evaluate the effects of oral curcumin and turmeric on sebum production in     healthy subjects.   "
18305|NCT03045939|"     This study will evaluate the insertion of double balloon device (DBD) for cervical ripening     for 12 h vs 6 hours.   "
16699|NCT03066921|"     Previous studies found that lactic acid bacteria could inhibit the activity of the     performance of aristolochic acids (AAs) and improve apoptosis of proximal tubular epithelial     cells (NRK-52E) and renal fibrosis on rats. The aim of this study is to assessment a novel     health food of lactic acid bacteria for preventing renal dysfunction and replacing or     assisting conventional drug treatment. This study in 300 hemodialysis patients with dialysis     quality assessment index (KT/V, urea reduction ratio (URR), albumin, prealbumin, Hb, CRP…)     screened for more than three months, and the stability of the situation in dialysis patients.     They will be divided into two groups in order to conduct ergonomic assessments. One group     maintains their original diet and medicine. The other group will take the novel lactic acid     bacteria and placebo (1x1011 cfu/3±0.2 g/bag) in every morning and evening after their meals.     The effect of 0, 6, 12, 18, 24 weeks of the novel lactic acid bacteria will be assessed after     starvation for 4 weeks. Group C was the control group did not give any test samples, but     continued to observe. The overall goal of the aforementioned study is to develop a novel food     product of lactic acid bacteria which can improve dialysis quality for hemodialysis patients.     The investigators hope that this novel product can get a patent and be commercialized.   "
16700|NCT03066908|"     A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys®     Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus     irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis.   "
16701|NCT03066895|"     This is a pilot, randomized, safety and efficacy study of an investigational device (i.e.     BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain     subject feedback, assess device performance; and ascertain potential harm in healthy adult     volunteers.   "
16702|NCT03066882|"     Negative-calorie diet is among the popular dieting guides for weight loss; however, there is     still little knowledge about this method. The present study aimed to determine the effects of     negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with     low-calorie diet.   "
16703|NCT03066869|"     The purpose of this study is to evaluate the short- and long-term efficacy and safety of     Acthar for the treatment of adults with non-infectious retinal vasculitis.   "
16704|NCT03066856|"     Insulin-like growth factor I (IGF-I) and other markers of insulin resistance (IRm) might     modulate the penetrance of BRCA genes mutation.      The investigators have designed a demonstration project with BRCA mutation carriers (with or     without a previous diagnosis of breast cancer) to test:        1. whether a lifestyle intervention significantly reduceIGF-I and the other IRm (randomized          trial).        2. whether mutation carriers with a previous diagnosis of breast cancer have higher IRm          than carriers without breast cancer (case-controlstudy).        3. whether IRm and their change over time affect subsequent breast cancer incidence and          prognosis (cohort follow-up).      The investigators expect to significantly reduce IGF-I and IRm, to find that BRCA mutation     carriers with a previous breast cancer have higher IRm levels, and, in the long term, that     women with persistent higher IRm levels have higher penetrance and worst prognosis.      Confirming a significant reduction of IRm and the impact of their levels on prognosis would     help to develop primary prevention recommendations for high risk families.   "
16705|NCT03066843|"     This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA)     photodynamic therapy with different incubation times for the treatment of actinic keratosis.      Subjects who are interested in participating, currently living in the Chicago metropolitan     area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will     be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic     and health data will be collected prior to treatment initiation. Three visits will be     conducted: screening, treatment, and follow up visit at 8 weeks.      This study is a pilot study designed to determine feasibility of this procedure.   "
16706|NCT03066830|"     Primary Objective:      To demonstrate the superiority of sotagliflozin 400 mg versus placebo on Hemoglobin A1c     (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate     glycemic control with a sulfonylurea alone or in combination with metformin.      Secondary Objectives:        -  To compare sotagliflozin 400 mg versus placebo based on:        -  Change from baseline in fasting plasma glucose (FPG).        -  Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP          ≥130 mm Hg.        -  Change from baseline in SBP for all patients.        -  Change from baseline in body weight.        -  Proportion of patients with HbA1c <6.5% and <7.0%.        -  To evaluate the safety of sotagliflozin 400 mg versus placebo throughout the 79-week          trial.   "
16707|NCT03066817|"     Although vitamin D is known to play a major role in multiple organ functions in healthy     adults, including bone homeostasis, its role in the unique population of orthopaedic     polytrauma patients has not been well described. The aim of this therapeutic randomized     placebo-controlled feasibility study is to determine the effect of vitamin D supplementation     initiated on admission on patients' 25(OH)-D level, bone turnover markers, and clinical     outcomes in a cohort of adult orthopaedic polytrauma patients. Polytrauma patients with one     or more orthopaedic injuries admitted to an urban Level I trauma center will be screened for     eligibility based upon strict inclusion and exclusion criteria. Sixty patients meeting the     criteria will be consented, enrolled and randomized in a 1:1 ratio to intervention and     control (placebo) arm. Baseline 25(OH)-D and bone turnover marker levels will be drawn for     all the patients on admission, and the intervention arm will receive a one-time dose of     ergocalciferol (Vitamin D2) 400,000 IU shortly after enrollment. The labs will be repeated 7     days after the initial draw or at discharge, whichever occurs first. Patients' daily     immobilization status, baseline characteristics and clinical outcomes will be recorded.     Statistical methods will be used to assess whether there is a difference in 25(OH)-D and bone     turnover markers levels associated with the intervention.   "
17497|NCT03056521|"     Patients are randomized into 2 groups. The intervention group which receives preoperative     counseling about pain and a control group which does not receive this counseling.      The patients are followed up looking at pain scores and pain experience and satisfaction with     pain management for 2 days post operative.   "
16711|NCT03066765|"     Study of tongue implant for treatment of obstructive sleep apnea   "
16712|NCT03066752|"     Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction.     Diminution of mental capacity has a pervasive and profound impact on their quality of life.     Subtle changes in white matter predict cognitive changes in these patients but how this     disrupts brain function remains unclear. Development of effective therapeutics to restore     normal cognition hinges on elucidating these functional changes. The investigators seek to     uncover the patho-physiological basis for cognitive decline in MS. The investigators     hypothesize that cognitive decline originates from disrupted gamma oscillations and that     gamma oscillations are disrupted by molecular changes triggered by demyelination.   "
16713|NCT03066739|"     The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid     antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance     following surgery.      There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose     remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL), or (3) high dose     remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL     naloxone).      The hypothesis of the study is that occurrence of remifentanil-induced hyperalgesia (low     score in mechanical pain threshold) in the HN group will be lower than in the HI group.   "
16714|NCT03066726|"     Ultrasound Doppler studies are used during pregnancy to help manage pregnancies complicated     by fetal growth restriction. The cerebroplacental ratio may predict adverse outcomes in low     risk pregnancies. In a prospective study, the investigators will examine whether fetuses with     an abnormal CPR at or near term are at increased risk for being delivered by cesarean,   "
16715|NCT03066713|"     Assess the impact of high antioxidant potato products on postprandial glycemic response and     subsequent appetite and food intake.   "
16716|NCT03066700|"     This is a retrospective study to identify the prognostic factors of the good outcomes in     patients who presented with upper GI bleeding from tumor and received Hemospray via endoscopy     for hemostatic control. The good outcomes were assessed by immediate hemostasis, rebleeding     at 72 hours as well as 7, 14 and 30 days following presentation at initial bleeding episode     and also 6-month survival rate.   "
16717|NCT03066687|"     The primary purpose of this study is to evaluate the effect of food on the relative     bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy     participants.   "
16718|NCT03066674|"     Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly     related to disability. The McKenzie method is one of most popular treatment options for LBP.      The objectives of this study are to determine the effect of the hands-on McKenzie program on     pain, disability, spine mobility, and posture deviations in subjects with derangement low     back pain.   "
16719|NCT03065907|"     The purpose of this research is to collect preliminary data in preparation for conducting a     randomized clinical trial to determine the relative effectiveness of vision rehabilitation in     improving overall visual ability (primary aim) and reducing depression (secondary aim) in     patients receiving anti-VEGF therapy for neovascular age-related macular degeneratioin     integrated over time.   "
16720|NCT03065894|"     This study aims to examine patient outcomes following risk stratification for low back pain     in Family Medicine combined with either matched physical therapy (PT - i.e.,     stratified-specific PT) treatments or current treatment in primary care across The University     of Vermont Health Network.   "
16721|NCT03065881|"     The primary objective of this study is to collect electroretinogram ERG measurements from     visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data     from the visually normal subjects will be used to create reference intervals for the device.     Secondary objectives of the study are to provide ERG waveforms representative of disease     states encountered and to analyze how well an ERG detects the various disease states     encountered.   "
16722|NCT03066661|"     Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3,     ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise     unable to access, an ongoing clinical trial for entrectinib.   "
16737|NCT03066466|"     Chronic Graft Versus Host Disease (GVHD) is one of the most challenging complications in long     term survivors of allogeneic stem cell transplantation. As the number of allogeneic stem cell     transplantations rises annually, the incidence of chronic GVHD rates have also increased due     to a variety of factors including but not limited to increasing use of peripheral blood stem     cell (PBSC) grafts, increasing age of both donors and recipients, and increased use of     matched unrelated donors. One study showed much lower than traditional acute GHVD rate and     chronic GHVD which is similar with historical rates when atorvastatin was administered     prophylactically to both the donors as well as recipients of matched related allogeneic stem     cell transplantation, lead to the interest in further examining the role of Atorvastatin in     relation to the development of GVHD. The investigator hypothesize that the administration of     atorvastatin in recipients of matched unrelated allogeneic stem cell transplantation, a group     with known higher incidence of chronic GHVD, would be a safe and effective method to reduce     the incidence of chronic GVHD. Matched related allogeneic stem cell transplantation     recipients will not be included in this study due to their significantly lower GVHD rates.     The definition and monitoring of our primary endpoint of GVHD is well established in clinical     trials in allogeneic stem cell transplantations and the investiagor will utilize the National     Institutes of Health (NIH) Staging System for the diagnosis and severity assessment of     chronic GVHD as well the recommendations from the NIH Consensus Conference for the conduct of     clinical trials in chronic GVHD.      Several secondary endpoints will be examined as defined below and include standard     complementary data in the examination of clinical trials in chronic GVHD again as laid out by     the NIH Consensus Conference for conduct of clinical trials in chronic GHVD.   "
16738|NCT03066453|"     The aim of this study is to investigate the efficacy of antibiotic therapy with any     antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser     inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the     case of positive results, the reduction of the duration of IV treatment of tobramycin from 14     days to 5 days would limit the risk of toxicity.   "
16724|NCT03066635|"     Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of     the most severe pains known to man, having a large impact on the sufferer's quality of life.     A parasympathetic dysfunction in CH has been suggested. The sphenopalatine ganglion has been     a target for treatment of primary headache disorders for more than a century but there are     several anatomic and physiologic studies that suggest that another cranial parasympathetic     ganglion, the otic ganglion (OG), might be also relevant in CH. In this study OG will be     blocked with botulinum toxin type A in a pilot study in 10 patients with chronic cluster     headache. Recruitment of patients will be solely in Norway. There is no data available to     determine the correct dosage of botulinum toxin. A similar neural structure that has been     blocked with botulinum toxin in humans is the sphenopalatine ganglion. The investigators     injected 10 patients suffering from intractable chronic cluster headache with botulinum toxin     in the sphenopalatine ganglion. 5 patients were given 25 IU and 5 patients were given 50 IU.     Even though the number of treated patients is low, there did not appear to be differences in     the adverse events profile between those who received 25 Iu and those who received 50 IU. The     investigators also previously injected 25 IU botulinum toxin towards the sphenopalatine     ganglion bilaterally (i.e. 25 IU in each side) in 10 patients suffering from intractable     chronic migraine. Doses of up to 25 IU have been injected in structures adjacent to the otic     ganglion, for instance in dystonia towards the lateral pterygoid muscle. Thus it was decided     for this study on injection towards the otic ganglion, to explore the safety of 12.5 and 25     IU of botulinum toxin.   "
16725|NCT03066622|"     This trial is a prospective, randomized, feasibility trial with the primary aim of comparing     how well oral rapidly dissolving olanzapine controls primary headache pain when compared to     the current treatment strategies used in emergency departments which often require     intravenous or intramuscular medications.   "
16726|NCT03066609|"     The purpose of this study is to determine if secukinumab is effective and safe in the     treatment of plaque type psoriasis   "
16727|NCT03066596|"     The overall goal of this research study is to test the effectiveness of a multifaceted and     multi-level prompting intervention in a real world urban primary care office setting on     improving provider-delivered guideline-based asthma care and reducing asthma morbidity among     urban children with persistent or uncontrolled asthma.   "
16728|NCT03066583|"     This study will compare meniscal healing augmented or without augmentation with platelet rich     plasma in primary meniscal tear treatment (prolotherapy). The assessments will include     validated, disease specific, patient oriented outcome measures. Results of this study will     help ascertain whether platelet rich plasma may improve meniscal healing rates.   "
16730|NCT03066557|"     Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is     lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only     choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3     months. The treatment of advanced HCC still has a long way to go.      At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC     are ongoing. Based on our important discovery of previous clinical studies, we intend to     enlarge the sample size and make further observation for the efficacy and safety of apatinib     in patients with advanced HCC.   "
16731|NCT03066544|"     The main goal of this study is to determine whether it is possible - in the setup of routine     clinical care - to identify in individual patients who are clear responders to drug X, common     denominators that are absent in individual patients who are non-responders to the same drug,     and vice versa. All currently available knowledge about migraine pathophysiology will be     utilized, using as much time as is needed to ask as many questions as are necessary, in an     attempt to profile clear responders and clear non-responders.   "
16732|NCT03066531|"     The purpose of the present study is to compare an Acceptance and Commitment Therapy (ACT)     group intervention and a Cognitive Behavioral Therapy (CBT) group in a sample of obese     individuals with respect to mid-term outcome.   "
16733|NCT03066518|"     Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the     metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in     dementia.      Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep     quality.      Design: A single-center randomized, double-blinded, placebo-controlled study carried out on     outpatients with dementia and sleep alterations.      Participants: The investigators calculated a 40 individuals aged 65 years or over with a     diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).      Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every     night for 8 weeks.      Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality     Index (PSQI).   "
16734|NCT03066505|"     This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate     the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with     ADHD. A total of 40 subjects will be treated.   "
16735|NCT03066492|"     This randomized controlled trial examines the effects of a transitional care clinic for     high-risk patients at an academic medical center who had no trusted medical home. The trial     will provide the first reliable evaluation of the Northwestern Transitional Care Clinic /     Follow Up Clinic's (NFC) impact on re-admissions, care coordination, and costs. This research     will allow us to assess the value of the NFC and similar models of care for providing a more     coordinated care approach that results in better treatment outcomes for urban poor     populations.      It is hypothesized that NFC patients will have fewer 90-day re-hospitalizations and are more     likely to have a usual source of primary care 6 months after discharge.   "
16736|NCT03066479|"     This study is to evaluate a commercial tool on the market (Fitbit®) that also quantifies     sleep. No one has studied how pediatric patients perform with it and how accurate it is in     measuring their quality of sleep. This study will use the obstructive sleep apnea (OSA)     questionnaire completed by parents and Fitbit® together and evaluate how they perform against     the polysomnography (PSG).   "
17510|NCT03056352|"     Post-traumatic headache is common. We are determining short and longer-term outcomes among     patients treated for post-traumatic headache with IV metoclopramide.   "
16739|NCT03066440|"     Objectives: Intravenous (IV) fluid administration is a fundamental component of diabetic     ketoacidosis (DKA) treatment. Normal saline (NS), the most common IV fluid used in DKA     management, contains more chloride than human blood. Excessive amounts of chloride have been     shown to cause a detrimental metabolic acidosis. Other IV fluids have more physiologic     chloride levels, such as lactated ringers (LR). This study will compare the rates of     hyperchloremic metabolic acidosis in children treated with NS to those treated with LR to     determine the effect on overall length of acidosis and length of stay in the hospital or     intensive care unit.      Design: Single-center, double blinded, randomized controlled trial.      Subjects: Children aged 0 to 18 years who present with diabetic ketoacidosis and require     pediatric intensive care unit admission. Patients with evidence of shock, multi-organ failure     or clinically significant cerebral edema will be excluded. The projected study population     will be 104 patients, 52 in each arm.      Interventions: Patients will be enrolled within 1 hour of presentation to the emergency room     or pediatric intensive care unit if transferred directly from another facility. They will be     randomized to receive intravenous fluids containing 0.9% saline or lactated ringers. All     patients will be treated using the institutional DKA protocol with the content of the     intravenous fluids being the only difference in treatment between arms. Study intervention     lasts until the end of the acute management of DKA.      Planned measurements and study outcomes: The primary study outcome will be duration of     metabolic acidosis. Resolution of metabolic acidosis will be defined in three ways: 1.     Normalization of the ketosis; 2. Normalization of the serum pH; 3. Normalization of the serum     bicarbonate level. Secondary outcomes will include length of stay in the pediatric intensive     care unit and length of stay in the hospital. All outcomes will be correlated with the     overall chloride load given via intravenous fluids during DKA management. Regression     modelling will control for any baseline differences between the groups in regards to severity     of DKA, and if newly diagnosed or poorly controlled diabetes mellitus.   "
16740|NCT03066427|"     The therapeutic scenario of metastatic renal cancer is undergoing a new revolution with the     appearance of a novel therapeutic strategy after the antiangiogenic treatments, that is the     immunotherapy, in addition to the approval of new active drugs in the following lines of     treatment.      There are currently two phase III trials in the first line of treatment in metastatic renal     cancer that include different combinations of treatment based on immunotherapy. If results of     these studies were positive, the therapeutic algorithm would be modified so that the     remaining drugs would have to be repositioned within the therapeutic decision scheme.      Sunitinib has previously demonstrated its benefit in patients who had failed to prior     treatment with cytokines, so it is likely to continue to be effective in patients who have     become resistant to treatment with new drugs based on immune checkpoint blockade.      This phase II study is developed to evaluate the activity of sunitinib after treatment with     immunotherapy-based regimens that are currently being developed within phase III clinical     trials.   "
16741|NCT03066414|"     OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC)     and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST)     increase after a therapeutic bleeding in spontaneously breathing and non-obese patients with     genetic hemochromatosis.      DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.      PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.      INTERVENTIONS: Ultrasound measures and collected clinical parameters before and after a     therapeutic bleeding, during a standardized respiratory maneuver.      MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to     500ml therapeutic bleeding. It measured the minimal and maximal IVC and IJV diameters during     a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: [(maximal     diameter - minimal diameter)/maximal diameter].100.   "
16742|NCT03066401|"     OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC)     and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST)     increase after a therapeutic bleeding in spontaneously breathing and obese patients with     dysmetabolic hyperferricemia.      DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.      PATIENTS: Obese patients with dysmetabolic hyperferricemia undergoing a therapeutic bleeding.      INTERVENTIONS: The investigators performed ultrasound measures and collected clinical     parameters before and after a therapeutic bleeding, during a standardized respiratory     maneuver.      MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to     500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC and IJV     diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as     follows: [(maximal diameter - minimal diameter)/maximal diameter].100.   "
16750|NCT03066297|"     The investigatros hypothesized that selection of surgical procedure according to the     pre-defined institutional decision-making algorithm will not compromise the treatment     outcomes including overall survival and disease-free survival in participants with clinical     stage IA non-small cell lung cancer.      The purpose of this study is to determine the outcome of participants with clinical stage IA     NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or     lobectomy) according to the institutional decision-making algorithm      The investigators are planning to enroll 1,000 participants who meet the pre-defined     eligibility criteria over 5 years.   "
16751|NCT03066284|"     Using qualitative method; a qualitative case study using semi-structured interviews to     explore patients' experiences. Study population of insulin pump patients aged 11-18 years old     will be recruited from pediatrics with T1D at Dasman Diabetes Institute; who started using     CSII at least one year ago and their parents. Semi-structured interviews will be recorded and     then transcribed word by word. Data analysis will be performed using an inductive thematic     approach.   "
16743|NCT03066388|"     It has been well established that only 40 to 60% of the patients hospitalized for     inflammatory response syndrome (SIRS) positively respond to volume expansion (VE). The fluid     responsiveness is usually estimated by assessing VE-induced change in stroke volume (SV). To     guide prescriptions and possibly avoid deleterious effects of inappropriate VE, several     clinical studies demonstrated that invasive dynamic indices based on heart-lung interactions     permit an accurate prediction of the hemodynamic effects induced by VE.      Mechanical ventilation induces cyclic changes in intrathoracic and transpulmonary pressures     that transiently affect venous return, right and left ventricular preload, resulting in     pronounced cyclic changes in SV in preload-dependent, but not in preload-independent     patients. These cyclic changes in SV can be evaluated by the cyclic changes in arterial pulse     pressure. Several studies have shown that pulse pressure variation is able to predict fluid     responsiveness in patients in the operating room and intensive care unit (ICU).      However, this technique requires percutaneous arterial catheterization, which is associated     with several rare but serious complications (thrombosis, infections, pseudoaneurysm,hematoma,     and bleeding).      A method for assessing noninvasive arterial blood pressure using an electropneumatic control     loop was introduced by Penaz in 1973. Briefly, the blood volume in a finger is measured and     kept constant by applying corresponding external pressure. The continuously changing external     pressure needed to keep the volume constant directly corresponds to the arterial pressure     and, therefore can be used as continuous measurement of arterial blood pressure. Numerous     studies evaluating the accuracy of this technology, e.g., Finapres™ (Ohmeda Monitoring     Systems, Englewood, CO), and more recently of the Infinity CNAP™ SmartPod (Dräger Medical AG     & Co.KG, Lübeck, Germany).      The basic operating principle of the CNAP™ is similar to the Finapres™, but CNAP™ uses     multiple control loops. It has recently been shown that CNAP provides real-time estimates of     mean arterial blood pressure (MAP) comparable with those measured by an invasive     intraarterial catheter system during general anaesthesia.      The accuracy of the measures and the respiratory variations in pulse pressure obtained with     the CNAP system have not yet been studied in ICU.   "
16744|NCT03066375|"     Objectives: To investigate whether respiratory variations of inferior vena cava diameters     (cIVC) predict fluid responsiveness in spontaneously breathing patients with septic acute     circulatory failure and irregular heartbeats.      Design: Prospective, bicentric study, intensive care units.      Patients and measures: Spontaneously breathing patients with sepsis and clinical signs of     acute circulatory failure are included. A positive response to fluid loading (FL) is defined     as an increase of the stroke volume (SV) >10%. The investigators measured the minimum     inspiratory and maximum expiratory diameters of the IVC (idIVC and edIVC) during standardized     (st) and unstandardized (ns) breathing. The investigators calculated cIVCst and cIVCns before     a 500ml-colloid FL.   "
16754|NCT03066245|"     Patients qualified for this study are those diagnosed with ABCs and failed to be treated with     other forms of classical therapies. In which, these patients will be engrafted with     biodegradable scaffolds seeded with Mesenchymal Stem Cells (MSCs) supplemented with Platelet     lysate.   "
16745|NCT03066362|"     Hypovolemia and acute circulatory failure affects more than 60% of patients hospitalized in     intensive care or resuscitation. The volume expansion (VE) by fluid replacement therapy is     the first treatment improve circulatory function. However, too much VE can be harmful. So,     the use of dynamic predictive indicators of fluid responsiveness is recommended in patients     with sepsis.In patients with spontaneous ventilation, few studies have evaluated these     parameters. In mechanical ventilation, indices based on the respiratory variation of the     diameters of vena cava have been studied and validated to predict the response to VE. However     there is no similar study in spontaneously breathing patients without ventilatory support.     The investigators hypothesize that the respiratory variations in the IVC diameters and     femoral artery flow during standardized respiratory cycles are predictive factors of fluid     responsiveness in spontaneously breathing patients with sepsis, acute circulatory failure,     and regular cardiac rhythm.   "
16746|NCT03066349|"     Patients who undergo in vitro fertilization with or without intracytoplasmic sperm injection     (IVF / ICSI) often experience an impact on their quality of life and emotional maladjustment     to treatment and outcome. Multiple contributors to this negative impact have been identified,     including interference with professional activities, expenses related to fertility treatment     and hormonal side effects. In-vitro maturation (IVM) of human oocytes obtained from minimally     stimulated or unstimulated ovaries offers a more patient friendly treatment option than the     conventional ovarian stimulation protocols for Assisted Reproductive Technology (ART)     treatment. Historically, IVM has been offered to women with increased ovarian response     (so-called high responders), typically women with polycystic ovaries (PCO/PCOS), who are at     increased risk for ovarian hyperstimulation syndrome (OHSS) if conventional ART protocols are     used. IVM treatment programs are characterised by a minimal administration of fertility     hormones, are less disruptive to patients' daily life through a reduced need for hormonal and     ultrasound monitoring, avoid a range of minor and major complications because of the reduced     hormonal burden of this procedure, and aim to reduce the total cost for of infertility     treatment.      To facilitate the application of IVM as a treatment that can potentially improve the overall     patient experience, a study comparing the psychological impact of a conventional ovarian     stimulation protocol versus an IVM protocol will be conducted; furthermore, a study     investigating the differences in quality of life between the two subgroups will also be     performed.      Socio-demographic data, medical characteristics and the following questionnaires will be     collected: Specific questions for patients with fertility problems (FertiQol); Hospital     Anxiety and Depression Scale (HAD) and an instrument to measure side effects designed by the     research group. The study group (IVF patients and IVM patients) will be evaluated at three     predefined time points: at intake, after oocyte collection and when the outcome after the     first embryo transfer is known.      Descriptive analysis, intergroup comparisons and explanatory/predictive model of the     dependent variables (quality of life, emotional adjustment) will be performed.   "
16747|NCT03066336|"     The purpose of this study is to determine whether low level laser therapy (LLLT) using the     Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis.   "
16748|NCT03066323|"     This study is designed as a randomized, single blind (data evaluation), placebo controlled,     full cross-over study and conducted in 166 (including 10% drop out) males and females, aged ≥     18 and ≤ 65 and waist circumference of >80 cm for women and >94 cm for men (indicating     increased risk of metabolic complications (WHO)) and having a sedentary lifestyle. Subjects     will receive rice with a tea extract and rice without a tea extract.      There will be three visits to the test facility: one screening visit and two intervention     visits. During the intervention visits venous blood samples will be collected for the     analysis of plasma glucose (t = -30m, -5m, 15m, 30m, 45m, 1h, 1h 30m, 2h and 3h, relative to     the start of rice consumption ) and serum insulin (t = -5m, 30m, 1h, 2h and 3h).      Between the two intervention visits subjects have an interval of one week. This interval is     required to minimize subject discomfort from repeated blood sampling.   "
16749|NCT03066310|"     DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder     cancer. Many genetic alterations have been identified in the urinary DNA. However, not all     bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach     satisfactory sensitivity and specificity a new diagnostic test should include multiple     biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations     in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross     hematuria for cystoscope.   "
20943|NCT03011450|"     The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients     With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal     Impairment.   "
16753|NCT03066258|"     Excessive vascular endothelial growth factor (VEGF) plays a key part in promoting     neovascularization and edema in neovascular (wet) age-related macular degeneration (nAMD).     VEGF inhibitors (anti-VEGF), including ranibizumab (LUCENTIS®, Genentech) and aflibercept     (EYLEA®, Regeneron), have been shown to be safe and effective for treating nAMD and have     demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via     intravitreal injection and can be a significant burden to the patients. RGX-314 is a     recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a     soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein     following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment     burden of currently available therapies while maintaining vision with a favorable     benefit:risk profile.   "
25063|NCT02957630|"     The proposed study will provide an assessment of the effect of this combination on endocrine     function, metabolic control and hemostasis during 6 treatment cycles. This will be compared     to the effects of two reference COCs.   "
16759|NCT03066180|"     This is a prospective, pilot clinical study involving two study groups. This study is     designed to demonstrate that the study treatment meets primary efficacy and safety endpoints.     The treatment involves radiofrequency treatment to address symptoms of stress urinary     incontinence.      After receiving the study treatment, subjects will be followed out to 12 months     post-treatment. At the Screening Visit, and at each designated follow-up timepoint, subjects     will be asked to complete a variety of questionnaires, provide a patient diary, and undergo     an objective assessment for urine loss.   "
16760|NCT03066167|"     This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the     oesophagus and gastro-oesophageal junction and to the Swedish language.   "
16761|NCT03066154|"     The optimal treatment for HRPC patients has not yet been established. Recent trials suggest a     benefit from early treatment with docetaxel in the castration-sensitive setting, with an     improvement in failure free survival in high risk and metastatic patients and increase in     overall survival in the metastatic hormone-sensitive group. In these recent randomized     controlled trials, patients were treated with hormonal therapy and radiotherapy and adjuvant     docetaxel, assuming that early systemic treatment for high risk or metastatic disease could     delay progression in patients with aggressive primary tumor characteristics.      With the fact that docetaxel is a known radiosensitizer, combined modality treatment with     docetaxel during the radiotherapy could also lead to better local control and reduction of     local recurrence. Several phase I and II studies have been done in HRPC patients, to evaluate     the combination of high dose radiotherapy and concurrent weekly infusions with docetaxel.      Oral administration of docetaxel has many advantages above intravenously administered drugs     for patients. Besides the higher patient convenience, possibly longer treatment duration can     be achieved due to better safety. Frequently occurring toxicities of intravenously     administered docetaxel, such as neutropenia, hypersensitivity reactions and peripheral     polyneuropathy have rarely been observed with the oral docetaxel formulation ModraDoc006/r.      The primary aim of the N15DOP study is to determine the maximum tolerable dose (MTD) of     ModraDoc006/r when given in a weekly bidaily schedule in combined modality with high dose     intensity radiotherapy and hormonal therapy in castration-sensitive prostate cancer patients     with high risk disease, including positive lymph nodes.   "
16762|NCT03066141|"     It is widely accepted that coronary artery disease (CAD) is related to a high mortality. It     is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7     million cardiovascular deaths over 2010 to 2030 in China.1 Male sex, diabetes mellitus,     hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as     risk factors for CAD. In recent decades, tremendous progress toward the prevention and     treatment of traditional cardiovascular risk factors have helped decrease the morbidity and     mortality from CAD, but the condition remains a major public health challenge worldwide.     Looking into the other potential risk factors (OSA) for CAD, it may help to develop     additional preventative strategies and further reduce the incidence and mortality of CAD.   "
16763|NCT03066128|"     Effective management of patients on antiretroviral therapy (ART) is essential to improve     clinical outcomes and prevent HIV transmission, but monitoring life-long ART for over 15     million HIV-infected people has become a challenge, particularly in low- and middle-income     countries (LMICs). As programs continue to focus on identifying HIV-infected people and     starting ART at higher CD4 thresholds, HIV providers have been overburdened, which has     resulted in falling retention rates. As ART coverage scales up to include millions more     people, additional strain will be placed on HIV clinicians and laboratories to manage stable     patients on chronic ART. Implementing point-of-care HIV VL testing to enable task shifting to     nurses for chronic HIV care may help mitigate these burdens. Point-of-care Viral Load (VL)     testing is intended to differentiate patients who are potentially failing on their ART, so     that they can be referred to the next level of care for possible ART regiment change, from     patients who are virally suppressed on ART and can be managed by nurses. The investigator's     scientific objective is to test the clinical equivalence and reduced cost of implementing a     model for chronic HIV care that uses a point-of-care HIV VL assay to enable streamlined care     and task shifting among healthcare workers at an urban clinic in South Africa. The central     hypothesis is that rapid HIV VL testing, implemented by nurses, is an effective and     cost-efficient strategy for management of chronic HIV infection in the majority of patients,     thereby allowing more resources to be directed at the minority of patients who need greater     attention. This work is innovative because it uses a randomized evaluation of an     implementation model that combines a novel diagnostic point-of-care test with streamlined     care and task shifting among healthcare workers compared to standard of care for chronic HIV     care in a resource-limited setting. This randomized trial will then form the basis of a     larger, multicountry proposal to demonstrate the clinical equivalence and cost-effectiveness     of implementing an integrated point-of-care HIV VL testing and streamlined care model for     chronic HIV care in LMICs. If nurses using clinic-based HIV VL testing are cost-effective for     achieving both viral suppression and retention in care among patients on ART, then     implementation of this chronic HIV care model would alleviate the strain on existing HIV     providers and laboratories in LMICs.   "
16764|NCT03066115|"     Elucidating cerebrovascular control mechanisms during physiologic stress may help identify     novel therapeutic targets aimed at preventing or reducing the impact of cerebrovascular     disease. The physiological stressors of hypoxia and hypercapnia will be utilized to elicit     increases in cerebral blood flow (CBF), and intravenously infused drugs will allow for the     testing of potential mechanisms of cerebrovascular control. Specifically, the contributions     of nitric oxide synthase (NOS), cyclooxygenase (COX), and reactive oxygen species (ROS) to     hypoxic and hypercapnic increases in CBF will be examined. The concept that these mechanisms     interact in a compensatory fashion to ensure adequate CBF during both hypoxia and hypercapnia     will also be tested.      ~25 young, healthy men and women will be tested at rest and during hypoxia and hypercapnia.     Subjects will participate in two randomized, counterbalanced study visits under the following     conditions: inhibition of NOS, NOS-COX, and NOS-COX-ROS or inhibition of COX, COX-NOS,     COX-NOS-ROS. During hypoxia, arterial oxygen saturation will be lowered to 80% and end-tidal     carbon dioxide will be maintained at basal levels. During hypercapnia arterial carbon dioxide     will be increased ~10 mmHg above basal levels and arterial oxygen saturation will be     maintained. Blood flow velocity will be measured with transcranial Doppler ultrasound in the     anterior (middle cerebral artery; MCA) and posterior (basilar artery; BA) circulations as a     surrogate for CBF.      It is hypothesized that both NOS and COX independently contribute to hypoxic and hypercapnic     vasodilation in the MCA and BA, combined NOS-COX contribute to hypoxic and hypercapnic     vasodilation in MCA and BA to a greater extent than either NOS or COX alone, and NOS-COX-ROS     contribute to hypoxic and hypercapnic vasodilation in the MCA and BA to a greater extent than     NOS-COX.   "
16765|NCT03066102|"     The aims of this study are to investigate the effects of scapular muscle fatigue on scapular     joint position sense and neuromuscular performance (scapular muscle strength, the kinematics     data and muscle activity of shoulder during scaption (arm elevation in the scapular plane)).     The investigators hypothesize that scapular muscle fatigue would increase scapular reposition     error and affect neuromuscular performance of the scapular during scaption.   "
16766|NCT03066089|"     This study is an open label, two armed trial evaluating the safety and efficacy of Fenfuro     capsule twice daily for 90 days in 100 patients with type 2 diabetes that will be conducted     in single center in India. The primary outcome measures will be the determination of decrease     in plasma glucose levels from baseline to last visit. The secondary outcome will be the     determination of safety of Fenfuro capsule in type 2 diabetic subjects.   "
18415|NCT03044509|"     1. The primary objective is to improve the sensitivity of novel immunodiagnostic tests for          detection of TB disease in children.        2. The secondary objective is to determine biomarkers that discriminate children with TB          infection and disease.   "
16767|NCT03066076|"     Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising     through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor     (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the     extraocular muscles and an increase in retroorbital fat. There are currently three forms of     therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total     thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and     GO.      Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe     GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which     GO stays the same following the initial decrease in ATD therapy after 6 months.      Methods: This prospective randomized clinical trial with observer blinded analysis will     analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery.     Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody     levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index     measurements via ultrasound and quality of life score.   "
16769|NCT03066037|"     There is a significant debate whether local infiltration techniques may be a method to treat     complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of     evidence regarding efficacy of this treatment especially in long term follow up. Similarly,     indication and management are under debate. Aim of this trial is to analyse pain scores     during first treatment with anaesthesiological infiltration series.   "
16770|NCT03066024|"     As part of the clinical routine of the Department of Anesthesiology and Intensive Care     Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative     electroencephalography data and clinical routine data are recorded and evaluated in surgical     children and adolescents according to different age groups.   "
16771|NCT03066011|"     The purpose of this study is to describe representative real-world patterns of care for the     management of invasive fungal infections (IFIs), including invasive mold infection (IMI).     Specifically, the study goals are to examine real world patient characteristics and treatment     patterns, associated healthcare resource utilization, and outcomes associated with use of     mold-active triazoles (MATs) to treat invasive fungal infections (IFIs).   "
16772|NCT03065998|"     The aim of this study is examining the combination of two FDA approved drugs, Opipramol and     baclofen, which may increase rehabilitation from psychoactive substances. Previous studies     have indicated a connection of sigma-1 receptor to cocaine abuse and raised the possibility     that these receptors as mediators of drug craving . However previous studies showed partial     efficacy with no significant relapse in relapse rates. The same is true for the use of     GABAb-1 receptor antagonist. Opipramol is a selective agonist for sigma-1 receptor. It is     clinically used as an antidepressant and anxiolytic agent. Moreover, previous open and     controlled trials indicated that the GABAb-1 antagonist baclofen partial efficacy in     suppressing withdrawal symptoms in alcohol addicts and cocaine. Our studies in an animal     model for addiction have shown a significant effect of the combine treatment of the indicated     medications both in decreasing relapse and increase of -number of respondents.   "
16773|NCT03065985|"     This study will assess if endoscopic ultrasound radiofrequency application in patients with     inoperable pancreatic cancer and chemotherapy confers survival benefit when compared to     patients receiving best medical care and chemotherapy .   "
16774|NCT03065972|"     This will be a prospective, single institution, parallel-group, single-blinded,     randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous     fistula versus hemodialysis access grafts in the elderly. The target sample size will include     enrollment of 270 patients over a period of 5 years. The creation of an autologous     arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of     the study.   "
16776|NCT03065946|"     Unconscious survivors of cardiac arrest who are treated with intravenous therapeutic     hypothermia for 24 hours will be assessed after 12 hours for appropriateness to be woken     early and extubated whilst continuing to receive therapeutic hypothermia. Sedation will be     reduced/stopped at 12 hours to enable a comprehensive neurological assessment utilising a     multimodal approach.      Providing the patient is clinically stable with no adverse neurological signs the patient     will be extubated. Patients who remain unconscious will be reviewed 6 hourly for neurological     recovery and their suitability to be extubated in line with standard practice.   "
16777|NCT03065933|"     The investigators plan to to study an extended-release form of clonidine, which the     investigators hope will be even better tolerated than the immediate-release form, as an     antimanic agent. Subjects will receive an extended-release form of clonidine in addition to     their usual medication regimen on the second day of this three-day study. Rating scales, a     record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3     days. Any medication changes made by the attending psychiatrist and prns administered will be     recorded throughout the study.   "
16809|NCT03065478|"     The objective of this observational study is to evaluate the effectiveness of the dietary     supplementation OnLife in improving signs and symptoms of chemotherapy-induced peripheral     neuropathy (CIPN) in adult patients who have finished adjuvant oxaliplatin-containing regimen     (colon cancer) or adjuvant paclitaxel regimen (breast cancer). Furthermore, patient-reported     outcomes (PROs) and concomitant medication used for the treatment of neuropathic pain will be     assessed.   "
16787|NCT03065764|"     After a screening phase of up to 42 days, eligible subjects will undergo two whole body     immuno-PET scans with a non-therapeutic tracer dose (2 mg) of 89Zr-pembrolizumab; one with     and one without a preceding cold therapeutic dose of pembrolizumab. For the first 3     patients, PET scans will be obtained at 1, 72 and 120 hours post tracer injection to     determine the optimal scan time point and to perform biodistribution measurements and     dosimetry. All subsequent patients receive only 1 PET scan post-injection (i.e. two PET     scans). The optimal time point is expected to be at day 5 post-injection. Pembrolizumab     treatment will continue every three weeks until two years of therapy have been administered,     disease progression, or unacceptable adverse event(s).   "
16778|NCT03065920|"     This study is a prospective observational multicentre cohort study of asthma patients in     Eastern Africa whose objectives will be; The primary objective of this project is to identify     and characterize severe asthma in Eastern Africa in order to understand its demographic,     clinical, physiologic, pathologic, genomic and immunologic determinants.      Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room     visits, hospitalization including admission to critical care units and unscheduled outpatient     clinic or office visits), exacerbation, quality of life and mortality rates of severe and     not- severe asthma patients Determine the factors associated with the asthma HCU events,     quality of life, exacerbations and mortality The study will enroll 1676 patients aged between     12 and 70 years and follow up each patient for up to one year.   "
16779|NCT03065868|"     Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric     polyp (Ranomized controlled trial)        1. Study design: open labeled RCT        2. Study group H. pylori eradication group (N=30), non-eradication group (N=30)        3. Treatment plan             1. Baseline EGD                : 0.5-1cm sized polyp - bx & CLO test (antrum & body)                ==> if H. pylori positive and eligible patients, randomization             2. Triple therapy             3. UBT (4week after eradication)             4. Follow-up EGD: gross finding, CLO test        4. Evaluation of polyp regression             1. disappear             2. regression over 50% (size, number)             3. no change or increase (size, number)   "
16780|NCT03065855|"     Traditionally these catheters are retained for 7 days, because a higher incidence of urinary     retention is related to early removal of the urinary catheter. However, recently Enhanced     Recovery After Surgery presents that urinary catheters placed via the urethra can be     withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but     there is no clear data on the incidence of urine retention.Longer retaining time of urethral     catheter would induce the urinary tract infection while early removal of urethral catheter is     considered to develop acute retention of urine due to lack of sensation when the bladder is     full. Taking the comfort and mobility for faster rehabilitation of patients into account, the     investigators aim at obtain the optimal removal time of urinary catheter after after     laparoscopic anterior resection of the rectum   "
16781|NCT03065842|"     In many low-income countries, unsafe abortion is recognized as a leading cause of maternal     morbidity and mortality. Social stigma surrounding abortion and contraceptive use plays a     critical role in the social, medical, and legal marginalization of abortion and contraceptive     services. Though this stigma is pervasive and threatens women's health, it is not well     understood how it can be reduced. The Stigmatizing Attitudes, Beliefs and Actions Scale     (SABAS) was designed in 2013, to measure abortion stigma at individual and community level.     Objective: I) to conceptualize abortion stigma among; health care providers, secondary school     teachers and students, and II) to determine if a school based intervention targeting stigma     specifically faced by girls when accessing abortion and contraceptive services, compared to     usual standards, will decrease related stigma and increase contraceptive use among students,     who are sexually active. Design, Setting, Participants: I) Focus group discussions (FGD) with     service providers at YFC (n=12), secondary school teachers (n=16) and secondary school     students (n=20), and II) a quasi-experimental pre- and post-intervention study, targeting 800     secondary school students (14-20 y), in Kisumu, Kenya. Two schools will be cluster-randomised     into one interventions unit (n=400 students) and one control unit (n=400 students), according     to the study site, size and academic standards of school. The region is chosen because of its     low rate of contraceptive use and high rate of unsafe abortion. Standard deviation is the     measure of dispersion or variability in the data. The sample size of 400 is based on a     previous study and will give a power of 80% to detect differences (95% Cl) between the two     groups (sample size and power will be re-calculated after baseline and take into account     variability (SD) in the data). Intervention: An abortion- and contraceptive-use stigma     reduction intervention (1-month program), capturing negative stereotypes about women that are     associated with abortion and contraceptive use. Main Outcome (re-calculated after baseline):     Abortion-stigma reduction. Secondary outcome: Contraceptive-use stigma reduction. Measured at     baseline (pre-test), and post-test at 1- and 12-months, by using the validated SABA-scale.     Analyses: Qualitative content analysis and repeated measures, ANOVA.      Funded by: The Swedish Research Council for Health, Working Life and Welfare 2015-01194, and     The Swedish Research Council 2016-05670   "
16782|NCT03065829|"     For family members of chronically critically ill (CCI) patients, an ICU admission marks a     significant milestone in the patient's illness trajectory that highlights the onset of end     of-life issues and an abrupt need for family members to assume the caregiver role for the     first time. Assuming the caregiver role can have devastating and longstanding health     consequences for family members, which can impair their ability to sustain caregiving     behaviors for a CCI patient. The unrelenting psychological distress perceived by caregivers     of CCI patients is linked to significant reductions in their self-management and health     outcomes.      The purpose of this study is to evaluate a theoretically-derived Adaptive SenSor-Based     Intervention for Caregiver Self-ManagemenT (ASSIST) intervention compared to an attention     control condition for first time caregivers of CCI patients discharged to an extended care     facility. One group will be exposed to the ASSIST intervention and will wear the sensor-based     technology for 30 days and receive a daily dose of MMT. Biophysical sensor data (blood     pressure, heart-rate variability, pedometry, and actigraphy) will be continuously acquired     and analyzed using anomaly detection and machine learning techniques to vary the dose     intensity (number of doses per day) of the two components of ASSIST adding a real-time,     adaptive feature to promote caregiver self-management. The other group will wear the     sensor-based technology for 30 days but will not receive the daily dose of MMT. The     investigators will randomly assign participants to each group.   "
16783|NCT03065816|"     Primary Objective:      Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of     alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets,     in healthy adult subjects.      Secondary Objective:      Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in     healthy adult subjects.   "
16810|NCT03065465|"     The primary specific aim is to perform a randomized controlled trial (RCT) to compare the     rebleeding rates and other clinical outcomes of severe, refractory or recurrent non-variceal     upper GI hemorrhage (NVUGIH) with a new over-the-scope hemoclipping device (OVESCO) versus     standard endoscopic hemostasis.   "
16784|NCT03065803|"     Introduction and evaluation of a new technique for socket preservation involving internal     expansion of the buccal plate of the extraction socket using internal flapless corticotomy     and bone grafting the extraction socket with application of bioresorbable membrane     biomaterials in comparison with the conventional guided bone regeneration technique for a     conventional socket preservation method hoping to maintain or improve hard and soft tissue     contour of the alveolar ridge post tooth extraction.   "
16785|NCT03065790|"     Adult patients with non-Hodgkin lymphoma who will be treated with lenalidomide will undergo     FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be     correlated response and long term outcomes.   "
16786|NCT03065777|"     Assessment of postoperative pain after root canal treatment using different rotary systems.   "
16788|NCT03065751|"     Sepsis is defined by the occurrence of a systemic inflammatory response syndrome (SIRS) in     the context of infection. Unfortunately, its incidence appears to be rising, and the     mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from     shock and multi organ dysfunction that are - at least in part - triggered by an inadequate     response of the host's immune system to the infection. Given the injurious role of 1) this     overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF     cleaving proteases, hemostatic factors etc.) while the disease is progressing the     investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely     ill individuals might improve hemodynamics, oxygenation and ultimately survival. This     therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful     circulating molecules and 2. replacement of protective plasma proteins. The investigators     designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an     add-on treatment to state of the art standard sepsis care. Only patients with early septic     shock (< 12 hrs) and high catecholamine doses (noradrenaline > 0.4 ug/kg bodyweight/min) will     be included. Those in the treatment group will receive 3 TPEs within three consecutive days.     The primary outcome is 28-day all cause mortality. To show an assumed reduction from 60% to     45% in the experimental group, a sample size of 173 patients per group has been calculated.     The overall sample size is therefore n=346. The recruitment period is 3 years (+3 months     observation) and will be performed in 11 national centers in Germany. Secondary endpoints     (including hemodynamics, oxygenation, coagulation, and microcirculation) will be assessed on     day 1, 2, 3 before and after TPE and on day 4, 5, 7 and 14.      Project management and data monitoring will be organized by the Hanover Clinical Trial Center     and biostatistics including a web-based randomization will be performed by the Institute of     biometrics (Prof. Koch) at Hannover Medical School.      The investigators hope to demonstrate a potential benefit of an additive treatment approach     to improve the outcome of patients suffering from an under-recognized but deadly disease.   "
16789|NCT03065738|"     Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus     Deformity   "
16790|NCT03065725|"     The aim of this study is to examine if late FDG-PET/CT images after intravenous FDG injection     has a higher sensitivity and specificity in detecting local lymph node metastases in patients     with muscle invasive BC than FDG-PET/CT images 60 minutes after FDG injection. The latter     procedure has been used routinely until now.   "
16791|NCT03065712|"     This study will formally address the hypothesis that FES-PET/CT measurement of ER expression     predicts clinical benefit of first-line endocrine therapy in newly diagnosed ER+ metastatic     breast cancer patients and establishes the repeatability of FES PET/CT.   "
16792|NCT03065699|"     The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for     the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable     patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).   "
16793|NCT03065686|"     Despite significant progress made in identification on numerous genes and gene pathways     critical for craniofacial development, several approaches, ie mutation screening of specific     candidates, association studies and even genome-wide scans have largely failed to reveal the     molecular basis of NS human clefting. Moreover, the efficiency of Whole Exome Sequencing     -WES- was proven. The efficiency of WES was proven by the identification of the genes causing     Freeman Sheldon and Miller's syndrome, followed by several others. In the Picardy region,     management and follow-up of orofacial cleft patients are well-organised by a     multidisciplinary team in the university hospital of Amiens. The investigators therefore     decided to perform whole exome sequencing (WES) on precisely phenotyped non-syndromic CL/P     patients followed in our center.   "
16794|NCT03065673|"     Purpose: This study will determine the effectiveness of the use of desensitivity gels prior     in office bleaching on risk and intensity of tooth sensitivity caused by in-office bleaching     using 35% hydrogen peroxide. Materials and Methods: Fifty patients will be selected for this     triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10 minutes prior to     bleaching procedure, patients will receive the potassium oxalate 5% desensitivity gel and     placebo application on vestibular surface. The whitening treatment with 35% hydrogen peroxide     will be carried out in two sessions with a 7-day interval. Tooth sensitivity will be assessed     before, during and 24 hours after the procedure using analog visual and verbal scales. Color     alteration will be assessed by a Classical guide scale. Relative risk to sensitivity will be     calculated and adjusted by session; while comparison of overall risk will performed by     McNemar's test. Data on the sensitivity level for both scales and color shade will be     subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05)   "
16806|NCT03065517|"     The goal of this Phase II Small Business Innovation Research (SBIR) is to develop, evaluate,     and commercialize a linked parent-youth mobile app system, VillageWhere, to support the key     treatment targets of evidence-based treatments for youth with conduct disorders: clear     parental expectations, parental monitoring, discipline consistency, and parental support,     while simultaneously cultivating intrinsic motivation in youth toward prosocial behaviors.     When used in conjunction with an evidence-based treatment for delinquent youth, VillageWhere     could help reduce treatment length and cost. When provided in non-evidence-based clinical     settings, VillageWhere may increase access to state-of-the-art clinical techniques to those     who might not otherwise receive them. Investigators will conduct usability and acceptability     tests of new features with target-end-users (youth and their parents) and key stakeholders     (i.e., probation officers, clinic administrators). Once usability and acceptability is     achieved, investigators will conduct a 16-week randomized controlled trial (RCT) comparing     VillageWhere to an attention-control (placebo) mobile app. We expect that across four time     points, VillageWhere use will result in greater improvements in parent management practices     and youth autonomy support, parent-youth communication and connectedness, youth intrinsic     motivation for positive behavior, and youth conduct problems than the placebo. The RCT will     occur with 100 parent-youth dyads recruited from various treatment and probation settings,     and represent clinically-significant conduct-problems of various clinically-significant     severity levels.   "
16795|NCT03065660|"     Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies     end in miscarriage, and the number of miscarriages in England is estimated to be     approximately 125,000 per year. Miscarriage often brings not only physical pain, bleeding and     risks of infection, but also psychological impacts on women and their families. This study     will focus on women whose pregnancy sac remains inside the womb (known as a missed     miscarriage) and opt for medical management of their miscarriage up to 13+6 weeks of     pregnancy. NICE currently recommends that a drug called misoprostol (a vaginal pessary or     oral tablet that makes the womb contract) should be used in the medical treatment of     miscarriage. However, there is evidence to suggest that combining this drug with mifepristone     (an oral tablet that reduces pregnancy hormones) may be more effective in treating     miscarriage. Therefore, to test this in a clinical trial, participants will be allocated at     random to receive either mifepristone followed by misoprostol, or a dummy drug (placebo)     followed by misoprostol. Neither the participants nor the researchers will know what     allocation is decided, which is necessary to test the treatments fairly. The main outcome of     interest will be whether miscarriage is complete within 7 days of starting the tablets. If     miscarriage is not complete then further treatment (more tablets or surgery) will be offered.     A number of other key outcomes, such as the need for an operation, will also be assessed. We     will also study the views and experience of the participants regarding the tablet treatment.      We anticipate that 710 women will be required to take part in the study to answer this     question with confidence. We estimate that we would be able to recruit this many women in two     years.   "
16796|NCT03065647|"     In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest     (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is     to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support     (ACLS) at the scene until either the heart is restarted or resuscitation efforts are     considered hopeless and discontinued. An alternative strategy for those with refractory OHCA     is expedited transport with ongoing mechanical CPR to an Emergency Department capable of     performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to     test if this strategy is feasible and beneficial.   "
16797|NCT03065634|"     Based on a randomized controlled trial, the manualized group intervention Return to work and     living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will     be tested against a non-manualized control intervention (social counseling) in order to     evaluate the efficacy of the RELIANCE intervention compared to the control condition. The     study design includes two phases, the initial study phase (pilot study) and the intervention     study (RCT). The aim of the pilot study is to implement and ensure the necessary standardized     procedures for the implementation of patient recruitment and interventions. In the randomized     controlled trial, potential participants are assigned to the intervention group or to the     control group.   "
16798|NCT03065621|"     This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal     female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will     receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from     D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously     (each cycle of endocrine therapy consists of treatment from D1 to D28).      The endocrine therapy will be determined according to the menopausal status of the subject     evaluated at the study screening.   "
16799|NCT03065608|"     Temporomandibular joints dysfunction is a functional disorder concern with the abnormal     functioning of the muscles of the stomatognathic system, temporomandibular joints involved in     the dynamic movements of the jaw and surrounding structures.      The aim of the study was to compare the level of C-reactive protein in patients with pain and     painless form of temporomandibular joints dysfunction.   "
16800|NCT03065595|"     This study is a double-blind randomized controlled trial comparing the effect of     Ophiocephalus striatus extract in elderly patients with malnutrition. The measured outcomes     are the level of IGF-1, albumin, and MNA score.   "
16801|NCT03065582|"     Visible light is known to induce pigmentation in darker skin types. The investigators aim to     study the effects of visible light on the skin after topical application of sunscreen plus     antioxidant.   "
16802|NCT03065569|"     A trial comparing outcomes for different epidural techniques in labour analgesia   "
16803|NCT03065556|"     This Phase 2 study (Study 203) has been designed to determine and compare the efficacy and     safety of 188-0551 Solution and Vehicle Solution applied twice daily for up to four weeks in     subjects with plaque psoriasis. Subjects will be instructed to apply the test article     (188-0551 Solution or Vehicle Solution) to all psoriasis plaques within the designated     Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies     the subject's psoriasis has cleared at Day 15, then test article application will be for 2     weeks (Study Day 15).   "
16804|NCT03065543|"     A study conducted to evaluate the efficacy of lipid-lowering therapy in patients with high     and very high risk treated by interventional cardiology. Study endpoints:        1. Achievement of the target LDL-C at 1-year follow-up LDL-C <70 mg / dl in the group of          very high-risk and LDL-C <100 mg / dL in high-risk patients        2. Assessment of the lipid profile of the severity of coronary artery disease in patients          undergoing invasive diagnosis of coronary artery disease        3. Evaluation of trends in the treatment of lipid-lowering in patients in different years   "
16805|NCT03065530|"     Nervous, anxiety, fear and other psychological reactions always appears in parturients during     cesarean section. This study intends to investigate the effectiveness and safety of     dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and     breastfeeding after caesarean section.   "
16807|NCT03065504|"     A noticeably increasing number of patients are asking for naturally based extracts and     ingredients as supplementary dermatologic remedies. Patients are seeking natural and     cost-effective skin care alternatives in place of prescription medications and procedures.     This study will isolate the effects of oral turmeric and assess a combination tablet that     includes turmeric on sebum production in healthy subjects.   "
16808|NCT03065491|"     A large body of evidence confirm the cholesterol lowering effect of red yeast rice,     phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical     statins and cholesterol absorption inhibitors, it is plausible that their association will     provide a more relevant (and safe) LDL cholesterolemia reduction.   "
16811|NCT03065452|"     Lumbar stenosis (LSS) is the most frequent degenerative lumbar disease and is the most     frequent indication for spinal surgery. When non-invasive treatments fail, decompression     surgery is the gold standard therapy for the majority of patients and generally improves     symptoms.      However, few studies have investigated the improvement in posture (radiological parameters)     after surgery. In lumbar stenosis, patients may present a forward leaning posture (to relieve     pain), which is responsible for sagittal imbalance.      The aim of this prospective study was to evaluate the repercussions of decompression surgery     on sagittal balance and to compare these with aux clinical results. investigators included     patients operated on for isolated lumbar canal stenosis.   "
16812|NCT03065439|"     Purpose This trial study the association between SBT subgroups and postural stability. It is     theorized that cognitive impairment is more pronounced among patients in SBT group three     compared to SBT group one and two. Therefore, it is hypothesized that challenging patients'     balance will have a greater impact on the postural sway among patients in SBT group three     compared to SBT group one and two in conditions where sensory information is reduced and     cognitive load is increased.   "
16813|NCT03065426|"     This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric     surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify     correlates and predictors of observed weight loss trajectories following bariatric surgery.     This approach will expand current knowledge by examining the combined impact of empirically     supported behavioral and biological data in a large sample over time. Intensive measurement     of problematic eating behaviors, mood, and compliance with diet and exercise regimens     post-surgery will be analyzed in the context of lterations in parallel with, or in response     to, changes observed in the gut microbiota. Identifying these post-surgical predictors of     weight loss and comorbidity resolution will allow for the development of individualized     interventions to optimize surgery-related outcomes.   "
16814|NCT03065413|"     Prospective study. Starting from 2014 all newly appointed 1st year cadets in Naval Academies     will be enrolled until the class of 2025.      Physical examination, food frequency questionnaire, physical activity questionnaire,     anxiety/depression questionnaire, medical history will be filled out at first interview.      Specific blood tests will be performed. Every participant will be interviewed every three     years and will complete the same questionnaires.      Follow up period is determined ten years after last class enrollment   "
16815|NCT03065400|"     The purpose of this study is to test the effectiveness of a drug called pembrolizumab in     patients with Myeloproliferative Neoplasm (MPN); chronic phase (MF-CP), accelerated phase     (MPN-AP), or blast phase (MF-BP). Myelofibrosis neoplasm (MPN) is a group of diseases of the     bone marrow in which excessive cells are produced.      Pembrolizumab also known as Keytruda is a drug that has recently been approved in the United     Stated by the Food and Drug Administration (FDA) for the treatment of patients with     unresectable or metastatic melanoma and disease progression. Pembrolizumab is experimental in     the treatment of MPN. The researchers want to find out what effects, good and /or bad it has     on participants and the disease.      Participants qualify to take part in this research study if have been diagnosed with a MPN     blood disorder called myelofibrosis (MF). Accelerated (10-19% blasts in the blood or bone     marrow) and blast phase (>20% blasts in the blood or bone marrow) MPN has been a difficult     disease to treat. The term blasts refers to immature cells found in the bone marrow. They     are not fully developed, and therefore, do not yet carry out any particular function within     the body.      Funds for conducting this research are provided by Merck and Company, the manufacturer of the     study drug pembrolizumab.   "
16816|NCT03065387|"     There are 2 parts to this clinical research study: Part 1 (dose escalation) and Part 2     (expansion).      The goal of Part 1 of this study is to find the highest tolerable dose of neratinib in     combination with everolimus, Ibrance (palbociclib), or trametinib that can be given to     patients who have advanced cancer with a specific mutation (EGFR, HER2, HER3, or HER4).      The goal of Part 2 of this study is to learn if the dose of neratinib in combination with     everolimus, Ibrance (palbociclib), or trametinib found in Part 1 can help to control advanced     cancer in patients who have a specific mutation.      The safety of this drug will also be studied in both parts of the study.   "
16817|NCT03065374|"     This study will evaluate the safety and tolerability of IMM-529 together with standard of     care (SOC) in patients with Clostridium-difficile Infection.   "
16818|NCT03065361|"     The purpose of this study was to assess the handgrip strength; fine motor skills; and hand     sensitivity of Brazilian children and adolescents with Chronic Kidney Diseases (CKD). The     sample was composed by 42 children and adolescents, 21 on hemodialysis (group A) and the     other 21 acted as the control group (group B). The performance of both groups was compared.     The outcome measures included Jebsen-Taylor Hand Function Test, the Semmes Weinstein     monofilaments test and Jamar Dynamometer.   "
16819|NCT03065348|"     Major surgery in the elderly and frail patient is a challenge. Optimal perioperative     management is essential for outcome and survival. There is a need for improved     multidisciplinary approach to improve postoperative outcome in this patient population at     high risk for postoperative morbidity and mortality. Here the investigators will evaluate the     implementation of a multimodal prehabilitation program including optimization of nutrition     (protein and carbohydrate loading), optimization of preoperative hydration and the use of     regional anesthesia during cystectomy and urinary diversion in a series old frail patients     and compared/matched them to a historical series of similar patients in terms of early return     of quality of life using the Convalescence and Recovery Evaluation (CARE) instrument,     cognition, and postoperative morbidity.      The importance of patient-reported health status is well recognized and is a facet of     healthcare quality. In addition it is a valuable means for quantitatively measuring the     implication of technology adoption for the patient, who typically judges the efficacy of a     surgical procedure by whether it improves quality of life.      The objective of this study is to evaluate the implementation of a multimodal prehabilitation     program in a series old frail patients and compared them to a historical series of similar     frail patients in terms of early return of quality of life, cognition, and postoperative     morbidity. The importance of patient-reported health status is well recognized and is a facet     of healthcare quality. In addition it is a valuable means for quantitatively measuring the     implication of technology adoption for the patient, who typically judges the efficacy of a     surgical procedure by whether it improves quality of life.   "
16820|NCT03065335|"     Background:      Most medications that treat depression take weeks or months to work. Researchers want to     develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For     most people, this lasts a week or less. Repeated doses of ketamine may help maintain this     effect.      Objective:      To study the effects of ketamine in treating depression.      Eligibility:      People ages 18-65 with major depressive disorder and healthy volunteers      Design:      Participants will be screened in another study, with:        -  Medical and psychiatric history        -  Psychiatric and physical exam        -  Blood, urine, and heart tests      Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks.      Phase I (2-7 weeks):        -  Gradually stop current medications        -  MRI: Participants lie and perform tasks in a machine that takes pictures of the body.        -  Mood and thinking tests        -  Blood and urine tests        -  Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement          during sleep.        -  Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that          affects brain activity.        -  Stress tests: Electrodes on the skin measure reactions to loud noises or electric          shocks.      Phase I tests are repeated in Phases II and III and in the final visit.      Phase II (4 5 weeks):        -  4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone          over the head records brain activity.      Phase III (optional):        -  8 infusions of ketamine over 4 weeks      Phase IV (optional):        -  Symptoms monitoring for 4 weeks        -  Participants will have a final visit. They will be offered standard treatment at NIH for          up to 2 months.   "
16821|NCT03065322|"     Women with PCOS and OSA, compared to women with PCOS only, have more severe clinical and     biochemical features of PCOS and impaired QoL. This is an observational cross-sectional study     in a secondary care PCOS clinic in the WISDEM Centre, University Hospital Coventry.      The primary aim of this study is to examine the relationship between OSA and impaired QoL in     women with PCOS. Study secondary outcomes are to examine the relationship between OSA and the     clinical and biochemical features in women with PCOS.   "
16822|NCT03065309|"     This study will find the median effective dose of remifentanil for rapid sequence intubation     which avoids bradycardia and hypotension   "
16823|NCT03065296|"     This project will encompass an evaluation of the educational value of having evidence based     home exercise protocols available for family medicine residents in regard to the prescription     of home exercise treatment for common musculoskeletal conditions. Investigators will be     evaluating resident knowledge on home exercise prescription as well as their level of comfort     in educating their patients before and after a series of didactic sessions and implementation     of exercise protocols.   "
16824|NCT03065283|"     The aim of this study was to evaluate the immediate effects of diaphragmatic release     techniques on posterior chain flexibility and lumbar spine amplitude. Respiratory muscle     strength and chest cavity mobility in healthy women.   "
16825|NCT03065270|"     During pregnancy, pregnant women adopt an atypical pattern position with the intention to     maintain stability and balance.These postural changes can cause instability at the level of     the sacroiliac joint with painful condition during pregnancy and postpartum.      40 % of women have postpartum lumbopelvic instability. In 17 % of cases the lumbopelvic pain     is perpetuated.      Another alteration influenced by the gestational status and progress of labor is urinary     incontinence (UI).      The mechanism developed by Masai Barefoot Technology (MBT) provides an unstable base. Some     studies reviewed, indicate that this shoe increases muscle activity, contributes to the     decrease of joint overload and thereby, decreases pain.      Objective To compare the efficacy of shoes with unstable sole MBT®, over the use of     conventional sports shoes, in primiparous women with lumbopelvic postpartum pain.      Material and Methods Randomized clinical trial. 24 postpartum women from the Gynecology     Service of the Hospital Universitario Madrid Chiron were included in the study.      The subjects were randomly divided into experimental and control group.   "
16826|NCT03065257|"     This is a retrospective and prospective multicenter registry to collect long-term data (1     year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER,     etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal     neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the     tract wall.      Subjects will be consented for medical chart review.      The purpose of this retrospective and prospective registry is to assess long term data on     efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal     tract (1 year).      The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile     and overall clinical management through medical chart review. The procedures the     investigators are evaluating are all clinically indicated and will not be prescribed to     someone to participate in this registry study.   "
16827|NCT03065244|"     Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels     (coronary arteries) of infants and children and is now the most common cause of acquired     heart disease in children. A mixture of proteins from human blood (Intravenous     immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the     disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20%     of children are resistant to this treatment and the fever returns. These children have the     highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately,     there are no guidelines for the best secondary treatment for these resistant patients because     the problem has never been adequately studied. Most physicians choose either a second     infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that     promotes inflammation. This trial will randomize (assign by chance like the flip of a coin)     IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the     response to treatment will be compared to learn which treatment stops the fever the fastest.     In addition, parents and caregivers will provide observations about their child's response to     the different treatments.   "
16885|NCT03064490|"     This is a single-institution, prospective phase II trial with an initial safety run-in to     evaluate the efficacy and safety of neoadjuvant pembrolizumab combined with chemoradiotherapy     and adjuvant pembrolizumab in patients with locally advanced esophageal and gastric cancers     (EGC). Chemoradiation therapy (45Gy in 25 fractions with concurrent, weekly carboplatin [AUC     2] and paclitaxel [50mg/m2 of BSA]) with three cycles of pembrolizumab will be administered     as neoadjuvant therapy. These patients will also receive three cycles of adjuvant     pembrolizumab after surgical resection   "
16828|NCT03065231|"     Vasospasm is a common complication after rupture of intracranial aneurysms causing     devastating neurologic deficits and death. Vasospasm has been directly associated with the     amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to     refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the     optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and     lumbar drain (LD) have been compared retrospectively yet remain controversial as to which     method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would     be a prospective randomized trial in which patients would be assigned to EVD or LD and     observed to see if one method of intervention is associated with preventing clinical     vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need     for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an     optimal treatment modality to benefit all future patients with ruptured intracranial     aneurysms.   "
16829|NCT03065218|"     This study is being done to see if the radioisotope 99mTc sestamibi scans can locate what is     causing the elevated serum thyroglobulin in persons with differentiated thyroid cancer who     have elevated serum thyroglobulin levels and negative diagnostic imaging tests.      This is for patients with:        -  Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT          thyroglobulin antibodies ,        -  All NEGATIVE standard diagnostic clinical imaging studies (NSDCIS) = negative ultrasound          (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or          without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography          scan (18F-FDG PET) within the last 12 mos.        -  If EDCIS (extensive diagnostic clinical imaging studies of 18F-sodium fluoride positron          emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone          scan (99mTc MDP), AND negative brain CT or magnetic resonance (MR) are performed, these          are also negative.      Voluntary patients will have sestamibi scan performed in 4 phases:      Phase 1: receive an injection into their vein of a radioisotope called 99mTc sestamibi.      Phase 2: wait for 60 to 90 minutes in a waiting room      Phase 3: imaged lying face up on an imaging table while a camera passes around you from the     top of the head to approximately the level of knees. This requires approximately 45 minutes      Phase 4: images will be reviewed by the nuclear medicine physician. This will take ~10-15     minutes. If additional images are required to clarify an image, then additional images of     that area will be performed on the same camera or an alternate camera. As earlier, the     additional images performed lying face up. These images require ~20-45 minutes. The patient     will then be released.      The risk of this study is considered very low, and the potential benefits to the patient are     considered very high.   "
16830|NCT03065205|"     To determine if an asthma navigator is helpful in improving communication between care     providers and improving patient adherence to asthma medications after an asthma exacerbation.   "
16831|NCT03065192|"     Safety and efficacy of AADC gene transfer in participants with Parkinson's disease.   "
16832|NCT03065179|"     This is a multi-institution, single-arm phase II study to determine the safety and efficacy     of SBRT (up to 2 metastatic sites preferentially lung, mediastinum or bone in combination of     nivolumab and ipilimumab in patients with metastatic renal cell carcinoma(with a clear-cell     component and at least 1 measurable metastatic lesion that is not being irradiated).   "
16833|NCT03065166|"     This study assesses the acute effects of dried Cabernet grape intake on vascular function and     platelet reactivity in postmenopausal women. Previous studies from this lab and others have     demonstrated acute effects on vascular function and platelet reactivity from phenolic-rich     food sources. Postmenopausal women are suggested as the study group, as they are likely to     have compromised vascular function due to the loss of protective estrogen, and have been the     study group for past and present research projects in this lab.   "
16834|NCT03065153|"     The aim is to investigate the biomechanical interaction between trunk and gait performance in     both healthy and stroke subjects. People after stroke often have an impaired trunk function,     resulting in balance and gait disorders. Pathological movement patterns after stroke can be     compared with normative data as motion capture systems provide more sensitive data to explore     the interaction between trunk performance and gait in contrast to the clinical measures used     in literature.   "
16835|NCT03065140|"     Early research found that high levels of fat within muscle meant poorer control of blood     sugar. However, more recent research has shown that athletes have similar levels of fat     within muscle, but in contrast, they have very good control of blood sugar. The investigators     are not sure why this is and want to find out if the fat within muscle can be changed to     improve blood sugar control, as good blood sugar control reduces the risk of heart disease,     diabetes and stroke.   "
16836|NCT03065127|"     Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by     individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive,     limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this     study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG.     Participants in this study will undergo all three types of treatments in a randomized     counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a     period of 4 weeks.   "
16837|NCT03065114|"     Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality     before transfer. Under this tool, patients with a family history of genetic disease or     special genetic disease could avoid to produce chromosomal abnormalities of the next     pregnant. This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov.     Patients underwent PGS and data including the couples age, infertility factors, stimulation     protocols, medicine records, embryo quality records and blood tests were collected in this     study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo     quality is performed and further to find a diagnosis reference for clinical care.   "
16838|NCT03065101|"     The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding     Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.   "
16840|NCT03065075|"     To determine if phenazopyridine reduces the rate of postoperative urinary retention after     pelvic organ prolapse surgery.   "
16841|NCT03065062|"     This research study is studying a combination of drugs as a possible treatment for cancer     that might have a specific change in the phosphatidylinositol-3 phosphate (PI3K) pathway.   "
16886|NCT03064477|"     The present randomized, controlled trial will compare the cost-efficacy and acceptability of     the Unified Protocol in group format against traditional individual Cognitive Behavioral     Treatment in a sample of patients with emotional disorders. Ultimately, the goal of the     current study is to explore whether the Unified Protocol in group format can be a     cost-effective psychological intervention for emotional disorders in the Spanish National     Health System, that is, one that generates long-lasting changes in symptoms, while reducing     both direct and indirect economic costs associated with the treatment of emotional disorders.   "
16842|NCT03065049|"     The primary aim of this study is to develop a feasible, acceptable, and effective multilevel     physical activity (PA) intervention that addresses both individual and interpersonal factors     that can be easily scalable and delivered in the context of a methadone clinic. To do so, the     investigators will train methadone maintenance treatment (MMT) patients who are already     engaging in PA at public health recommended levels to deliver a group-based PA intervention     to physically inactive MMT patients at a large community-based methadone clinic. Through the     development of interpersonal relationships and social support, the investigators expect that     MMT peers who have successfully navigated challenges associated with PA in this population     (i.e. depression, smoking, triggers for drug use in environment) will help physically     inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.   "
16843|NCT03065036|"     The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous     Implant (Standard and Low-Profile), as determined by the change in IOP from baseline     (preoperative) and change in the number of glaucoma medications from baseline.   "
16845|NCT03065010|"     A Multicenter Open-label Non-comparative 2-Stage Phase 1a/1b Study to Assess the Safety and     Pharmacokinetics of Oral BCD-115 (JSC BIOCAD, Russia) in Combination with Endocrine Therapy     in Women with ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer   "
16846|NCT03064997|"     Prebiotics are known as substances affecting beneficially the organism by restoring the     intestinal microbiota balance, stabilizing the intestinal barrier and modulating the     endocrine and immune functions. In many persons suffering from celiac disease (CD), despite a     gluten-free diet (GFD), an impaired intestinal barrier functionality, accompanied by altered     intestinal microbiota and ongoing intestinal inflammation is observed. For these reasons,     prebiotic could be a promising and low-risk adjuvant in the dietetic management of CD. It was     hypothesize that prebiotic preparation Synergy 1 consumed by CD children as a supplement of a     GFD will affect beneficial the intestinal permeability and intestinal microbiota without side     effects.   "
16847|NCT03064984|"     Topical preparations (eye drops) derived from the blood have become a relatively common     treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate     the effect of two blood components from donors (serum cord blood and serum from adult subject     donor peripheral blood) in the treatment of severe keratopathies.   "
16848|NCT03064971|"     This study proposes to test the value of a culturally specific program for African American     smokers to quit smoking.   "
16849|NCT03064958|"     The investigators aim to conduct a 3-period randomized controlled crossover study to     investigate the postprandial effects of a high fat meal with spice on endothelial function,     lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress.     Metabolomic profiling will also be conducted. In random order, participants will consume     either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a     high fat meal containing 6g of spice. Between each treatment there will be a washout period     of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will     attenuate postprandial endothelial impairment and triglyceride levels in a dose response     manner compared with a high fat meal.   "
16850|NCT03064945|"     This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical     study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women     suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement     will be used to publish and promote recruitment.      The study will include 3 visits: Screening visit and two consecutive visits each one after     monthly menstrual period. Treatment will be self-administrated and during the study, the     subjects will be requested to complete home diaries.   "
16851|NCT03064932|"     This study is a randomized 3-period crossover, controlled feeding study designed to evaluate     the effects of the most commonly consumed spices in the U.S. on CVD risk factors,     inflammation & immune function, and diet satisfaction in participants at risk for CVD.   "
16852|NCT03064919|"     The purpose of this multi-year project is to develop an evidence-based curriculum for     teaching preschool children to eat in response to internal hunger and fullness signals. There     are currently no validated methods for teaching children these basic skills, despite the fact     that doing so is necessary to prevent the development of obesity.   "
16853|NCT03064906|"     To assess the safety and performance of the Insulet AP (artificial pancreas) system, using     the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model     predictive control algorithm in adults with type 1 diabetes consuming high fat meals and     undertaking moderate intensity exercise.   "
16854|NCT03064893|"     Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to     breast cancer patients and is considered an integral part of breast cancer treatment. In     general, breast reconstruction can be accomplished using the patients own tissues or     implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the     market and the costs vary widely despite very similar qualities. The two most commonly used     ADM products in North America by far are Dermacell and Alloderm. The difference between the     two products include a) level of sterility, with Dermacell being sterilized to 10-9 while     Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material     and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has     shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic     trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards     to the postoperative complications, namely infection, seroma formation (as measured by drain     duration and output), loss of implant, incidence of revisional surgery and capsular     contracture.   "
16898|NCT03064321|"     This study will test the effect of the an insomnia intervention with cognitive behavioral     treatment delivered via web compared with an information control group on glucose control and     self management behavioral in a sample of persons with type 2 diabetes (T2DM).   "
25113|NCT02956967|"     Non-interventional, non-comparative, national, multi-site, single-arm prospective     observational study to investigate home administration of Nivestim in the primary prophylaxis     of chemotherapy-Induced febrile neutropenia   "
18219|NCT03047057|"     Radical cystectomy remains the gold standard for treatment of patients with muscle invasive     bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. Postoperative     ileus is the most frequent reason for prolonged hospital stay following cystectomy.   "
16855|NCT03064880|"     Intraoperative goal-directed fluid therapy (GDFT) is proposed to improve the outcomes of     patients undergoing major surgery. In the GDFT algorithm, the employment of fluid bolus plays     a crucial role. Dynamic fluid responsiveness parameters, such as stroke volume (SV) response     to fluid infusion, are precise fluid indicators that specifically determine patient volume     status and are helpful for clinicians to determine the appropriate time for fluid bolus. In     this study, we compared two fluid strategies guided by SV response, namely maximization and     nonmaximization protocols, during intraoperative GDFT for patients undergoing thoracic     surgery requiring one-lung ventilation. Clinical outcomes and perioperative changes in serum     biomarkers of oxidative injury were compared between the two groups as the primary and     secondary outcomes respectively.   "
16856|NCT03064867|"     The purpose of this study is to determine the correct dose and safety of adding a new cancer     drug, venetoclax, to a standard combination of chemotherapy drugs as a second treatment for     relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab,     ifosfamide, carboplatin, etoposide), a common set to cancer drugs used as a second line     treatment for relapsed/refractory DLBCL.      Venetoclax, is a new targeted anti-cancer drug, which works by mimicking a particular protein     produced by the tumor and interrupting its normal processes, ultimately causing the tumor     cells to die. Adding venetoclax to the standard RICE regimen is believed to increase the     chance of getting cancer into remission.      Venetoclax is experimental because it is not approved by the Food and Drug Administration     (FDA) for the treatment of relapsed/refractory DLBCL. Venetoclax has been FDA approved for     use in patients with chronic lymphocytic leukemia (CLL).   "
16857|NCT03064854|"     The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or     recommended dose for expansion (RDE) of PDR001 when administered in combination with     platinum-doublet chemotherapy in treatment naive patients with PD-L1 unselected, advanced     NSCLC, and to estimate the preliminary anti-tumor activity of PDR001 in combination with     platinum-doublet chemotherapy in this patient population.   "
16858|NCT03064841|"     This is a multi-centre, cross-sectional, non-interventional study assessing blood glucose     target attainment, anti-hyperglycaemic treatment pattern and the clinical characteristics in     older outpatients with T2DM in hospitals of China. This study is designed to collect     information of older T2DM patients in a real life setting   "
16859|NCT03064828|"     This preliminary clinical trial aims to evaluate the performance of the low-dose CT     colonoscopy (CTC) with computer aided detection (CAD) on polyps detection compared with     optical colonoscopy (OC), and explore the possible clinical routine for integrated use of CT     colonoscopy and optical colonoscopy OC in colorectal cancer screening.   "
16860|NCT03064815|"     Inflammatory bowel disease is clinically associated with spondylarthropathies in 5-15% of     cases. Protocol colonoscopic assessment demonstrated asymptomatic inflammation characteristic     of Crohn's disease in up to 1/3 of SpA patients. Videocapsule endoscopy is a superior     diagnostic tool to detect small bowel mucosal pathology. However, it has been infrequently     used to evaluate bowel inflammation in spondylarthropathies. This study compared the accuracy     of videocapsule endoscopy to standard ileocolonoscopy for the detection of inflammatory bowel     lesions in patients with spondylarthropathies, and to describe the clinical and laboratory     predictors of small bowel inflammation in this cohort.   "
16861|NCT03064802|"     A multicenter patient registry was created with aim of documenting how spine and     neurosurgeons are utilizing Burst Biologics products along with patient outcomes. These     include radiographic measures such as fusion outcome, instrumentation integrity, and clinical     outcomes (symptom and function improvement) based on surgeon and patient based outcome     assessments.   "
16862|NCT03064789|"     Epidemiological study about the clinical and microbiological progress in subjects under     treatment for a severe vulvovaginal candidiases episody   "
16863|NCT03064776|"     m-RESIST is an m-health intervention program aimed to develop, test and evaluate a tool to     allow patients suffering from treatment-resistant schizophrenia to self-manage their     condition. This may facilitate acceptance and involvement of patients with their own     treatment, as well as of caregivers. Moreover this programme could provide a new tool to the     psychiatrist, psychologists working together with other health care professionals, to better     monitor patients, through a personalised and optimised therapeutic process.      The present document corresponds to the pilot field-trials phase included in a three year     European research project, co-funded by the Horizon 2020 Framework Programme of the European     Union (grant agreement nº 643552). This document summarises the protocol of the whole     therapeutic process, specifying all the procedures included in the program. This protocol     will be implemented in three countries: Israel, Hungary and Spain, in order to test     acceptability, usability, satisfaction and changes in the quality of life reported by the     end-users.   "
16864|NCT03064763|"     No formal statistical hypothesis will be tested for safety endpoints in this trial. Based on     the well tolerated safety profile from a global phase 3 study, it is hypothesized that     talimogene laherparepvec will be safe and well tolerated in Japanese subjects with     unresectable Stage IIIB-IVM1c melanoma. A DRR is hypothesized to be consistent with results     from the global phase 3 study   "
16865|NCT03064750|"     The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary     incontinence is high. There are many different surgical techniques for treatment of prolapse,     but there is a lack of knowledge about factors that contribute to objective result and     patient satisfaction after surgery.      The aim of the study is to investigate factors that could be related related to patient     satisfaction and objective result such as pelvic floor muscle contractility/strength and     muscle injury, objective measures of prolapse and women's symptoms. This study will     investigate whether systematic pelvic floor exercise and life style advise before surgery can     improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an     ultrasound scale for measure of pelvic floor muscle contraction.   "
16948|NCT03063671|"     This study investigate the effect of addition dexmedetomidine, ketamine or their combination     to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer     surgery.   "
16949|NCT03063658|"     This study will evaluate two different analgesic regimen used for acute postoperative pain.   "
16950|NCT03063645|"     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of     acetoacetate) levels after single dose administration of AC-1202 and 2 doses of AC-SD-01.   "
16866|NCT03064737|"     Legionnaires' disease (LD) is a relatively common pneumonia in France (1200 cases/year), 98%     of cases are hospitalized and 40% require intensive care unit (ICU) admission. Risk factors     that may predispose to acquisition of LD are well known. Some studies suggest that genetic     factor may also enhance susceptibility to LD.      The mortality rate remains high (10% to 33% in ICUs) despite improved diagnostic and     therapeutic management of patients. Few prospective studies have assessed the factors     associated with LD outcomes, particularly death, and most of them involved a limited number     of patients.      In a multicentre cohort study, the investigators recently identified risk factors associated     with higher mortality such as female sex, age, ICU stay, renal failure, corticosteroid     treatment and enhanced pro-inflammatory status, as assessed by higher C-reactive protein     level (PMID: 22005914). Other factors are suspected but their involvement has not been     formally demonstrated including a high infectious bacterial load, particular virulence of     Legionella strain, and an in vivo selection of mutants resistant to prescribed antibiotics.     Disease progression is highly variable from one patient to another, and usually remains     unpredictable. There are no objective criteria to predict the prognosis of these patients.      The clinical course of patients with LD remains difficult to predict because no predictive     biomarkers have yet been characterized and the demonstration of the presence of mutants to     antibiotics in vivo has never been done.      The main objective of the study is to correlate the L. pneumophila load (detected by PCR) to     the clinical outcome of the LD infection. Clinical severity will measured by the SOFA score     (Sepsis -Related Organ Failure Assessment) or the PELOD score (Pediatric Logistic Organ     Dysfunction).      Secondary objectives are to identify new host and bacterial biomarkers associated with poor     outcome of LD.   "
16867|NCT03064724|"     This pilot project examined the feasibility of an multilingual interactive video education     intervention an interactive Mobile Doctor intervention (iMD) to promote patient-provider     discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care     settings.   "
16868|NCT03064711|"     Background: Early diagnosis of respiratory impairment in Post-Polio (PPS) patients may delay     respiratory decline and future need of invasive respiratory aids.      Objectives: To compare pulmonary function measures, maximal respiratory pressure and activity     levels and fatigue of respiratory muscles between patients with PPS and healthy controls.      Design: Cross-sectional study. Setting: Hadassah physical medicine and rehabilitation     department, Jerusalem. Patients: Patients with PPS (N=12; 6 males; age 62.1±11.6 years) able     to walk for 6 minutes without human assistance; age-matched healthy subjects (N=12; 4 males;     age 62.2±6.5 years).      Intervention: None. Measurements: A body plethysmograph was used to quantify forced     expiratory volume in the first second of a forced expiratory maneuver, vital capacity, slow     vital capacity, Residual Volume (RV), Total Lung Capacity (TLC), and Thoracic Gas Volume     (TGV). Also, RV to TLC ratio is calculated. A manometer was used to measure Maximal     Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). A spirometer was used to     measure Maximal Voluntary Ventilation (MVV). Surface electromyography (sEMG) recorded     diaphragmatic muscle activity during rest and while performing MVV.   "
16869|NCT03064698|"     In uncomplicated pregnancies, the uterine spiral arteries undergo a series of structural     changes that result in a low resistance in the uterine arteries as pregnancy progresses.      In many pregnancies complicated with preeclampsia, growth restriction and other placental     related complication, the described change does not occur. In pregnancies at high risk for     placental complications, doppler measurement of Uterine artery flow has been shown to be a     reliable predictor of complications.      Postpartum there is a reversal of vascular changes seen in normal pregnancies. It is unclear     if there is a full reversal of these changes in complicated pregnancies with abnormal flow     during pregnancy.      The investigators hypothesize that Doppler uterine artery measurements after complicated     pregnancies will show some abnormality compared to doppler measurements following     uncomplicated pregnancies.   "
16870|NCT03064685|"     Objective: the aim of this study is to identify risk factors associated with the development     of pyogenic liver abscesses (PLA) in adult liver recipients (ALR) and to describe the     experience of the Hospital Italiano de Buenos Aires (HIBA) in the diagnosis and therapeutic     management of these patients.      Background: adult liver recipients differ from the general population with PLA as they     exhibit: reconstructed biliary anatomy, recurrent hospitalizations, regular performance     status and are subjected to immunosuppression. However, the scientific evidence regarding PLA     developed in transplanted organs is still scarce and the management of this disease continues     to be based on experience in non-transplanted patients.      Methods: between 1996 and 2016, 879 adult patients underwent liver transplantation (LT) at     our institution. Patients who developed PLA after LT (cases) and controls are matched     according to the time from transplant to abscess in a 1 to 5 relation. The investigators     performed a logistic regression model to establish PLA risk factors considering clusters for     matched cases and controls. Independent risk factors will be identified using multivariate     regression analysis.   "
16871|NCT03064672|"     This prospective cohort study aims to determine whether maternal and neonatal outcomes are     affected by GBS carrier status in women undergoing transcervical balloon catheter insertion.   "
16872|NCT03064659|"     During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower     than the minimum volume required to maintain the opening of the airways, there is a     derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation     (EFL).      The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the     Positive End-Expiratory Pressure (PEEP), and estimates the lung strain.      The incidence of EFL and the importance of DP are not known in adult cardiac surgery, so it's     necessary a study to assess both. The primary end-point of the study is to evaluate the     correlation of DP and EFL with PPCs in adult cardiac surgery. The secondary end-point of the     study is to evaluate: the mechanical ventilation time, the length of ICU and hospital stay,     the rehospitalization and mortality.      It will be a prospective, observational, non-pharmacological study. It will enroll 200     patients undergoing elective adult cardiac surgery.   "
16873|NCT03064646|"     PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal     cancer after a complete or almost complete response to neoadjuvant treatment is feasible and     safe in our environment.      The main objective of this project is to implement the organ preservation strategy in the     treatment of rectal cancer in our environment within a clinical study that allows the     analysis of its results in terms of survival.      The secondary objective is to assess local relapse, distant relapse and quality of life.   "
16964|NCT03063463|"     Currently there are no existing data to determine why some achalasia patients lose weight     while others do not. The purpose of this study is to gather data from patients diagnosed with     achalasia to determine if differences may be identified between those who lose weight and     those who do not that would help us better understand the mechanism of weight loss in this     population.   "
16874|NCT03064633|"     The transversus abdominis plane (TAP) block is most often used to provide surgical anesthesia     for minor, superficial procedures on the lower abdominal wall, or postoperative analgesia for     procedures below the umbilicus providing anesthesia to the ipsilateral lower abdomen below     the umbilicus.      In a recent meta-analysis, the TAP block was shown to reduce the need for postoperative     opioid use, increase the time to the first request for further analgesia, and provide more     effective pain relief, while decreasing opioid-related side effects such as sedation and     postoperative nausea and vomiting. The provision of effective postoperative analgesia is of     key importance to facilitate early ambulation and prevention of postoperative morbidity. The     analgesic regimen needs to meet the goals of providing safe, effective analgesia, with     minimal side effects. Many additives to local anesthetics used to prolong the duration of     analgesia for peripheral nerve blocks have been studied as dexamethasone, dexmedetomidine     Dexmedetomidine is a lipophilic α2 agonist derivative with a higher affinity for α2-receptors     than clonidine (α2: α1 specificity ratio is 200:1 for clonidine and 1600:1 for     dexmedetomidine). It has sedative, analgesic, and sympatholytic effects that blunt many of     the cardiovascular responses seen during the perioperative period. Animal and human studies     have shown safety and efficacy of adding dexmedetomidine to local anesthetics in various     regional anesthetic procedures. The addition of dexmedetomidine to bupivacaine in TAP block     achieves better local anesthesia and provides better pain control postoperatively without any     major side-effects.      Dexamethasone is a systemic glucocorticoid that improves the quality of recovery after     surgery by reducing pain, nausea, and vomiting. When added to local anesthetics as an     adjuvant in peripheral blocks, it prolongs the analgesia time. Mechanism of action may be     through the anti-inflammatory action, the increase of the local efficiency, and to slow down     of the absorption.      Objective:      The objective is to compare and evaluate efficacy and safety of dexmedetomidine and     dexamethasone as a local anesthetic adjuvant to bupivacaine in ultrasound-guided TAP block     for patients scheduled for total abdominal hysterectomies.   "
16875|NCT03064620|"     Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study.     The major specific aims:        1. To compare different PCV vaccination policies, by cross-sectional repeated surveillance          of closely related populations living in regions with different vaccination policies.        2. To compare the epidemiology, predictors and outcomes of antibiotic resistant S. aureus          and S. pneumoniae in different regions of the PICR.      Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and     nasopharyngeal S. pneumoniae carriage in children and one of their parents.   "
16876|NCT03064607|"     The purpose of the study is to quantify biomarkers of neural damage in neonates exposed to     varying levels of volatile anesthetic in utero.   "
16877|NCT03064594|"     This retrospective study is to find out the best way to treat patient with cornual pregnancy     in the aspect of further pregnancy outcome.   "
16878|NCT03064581|"     This community-based randomized trial tested the effects of a social support intervention to     increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among     their male spouses or significant others in Southern California.   "
16879|NCT03064568|"     Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss     when compared to vasopressin alone, which is our current practice at this time. The study     will be double-blinded with neither the patient nor the researcher knowing whether the     placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and     hematocrit, need for transfusion, and operative time among other measures of perioperative     morbidity to see if the addition of misoprostol makes a significant difference. We will also     observe patients to see if there are any side effects of misoprostol that make its use     undesirable.   "
16880|NCT03064555|"     Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to     ~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive     loss of kidney function where the patient requires dialysis to replace the typical functions     of the kidney. The quality of life of these individuals can be poor as a result of various     complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased     fitness). In an attempt to combat reduced physical fitness, many studies have applied long     term exercise programmes. However, the body's response to exercise in people with CKD is not     well understood and a set of guidelines that informs safe and effective exercise prescription     is lacking.   "
16881|NCT03064542|"     To determine how thyroid status regulates the relationship between brown adipose tissue (BAT)     volume/activity, white adipose tissue (WAT) partitioning and basal metabolic rate (BMR) in     hyperthyroid patients transitioning to euthyroidism via antithyroid drugs.      To compare euthyroid outcomes (BAT, WAT, BMR, body composition, body weight and insulin     resistance) achieved by hypothalamus-pituitary-thyroid (HPT) set point vs. normal ranges of     plasma free thyroxine 4 (FT4) and throxine stimulating hormone (TSH).   "
16882|NCT03064529|"     The present study aims to establish the feasibility of the clinical use of 3-axis     accelerometers to measure physical activity in hospitalized children after elective surgery.   "
16883|NCT03064516|"     Objective: To evaluate the immediate and mediate outcomes of endocrowns and onlay ceramic     restorations with glass fiber pin in endodontically treated teeth. Material and methods: A     randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by     two trained and calibrated operators who perform all restorative procedures. The restorations     are evaluated longitudinally by a blind and calibrated examiner using the USPHS. A total of     34 patients will be randomly assigned to each group for a total of 68 patients. The     randomization sequence will be generated (www.sealedenvelope.com) and to ensure the     confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in     series. These will be kept with an independent researcher for the moment of inclusion of the     subjects. In the group of onlays, the teeth receive a fiberglass pin in the main root canal     and composite resin filling. In the group of endocrown, only the restoration fill the pulp     chamber. The parts are milled in IPS e-max CAD (Ivoclar Vivadent) and cemented with the     Multilink cementation system (Ivoclar Vivadent). The immediate clinical (focused in     restoration and patient) and mediate (radiographic and clinical) outcomes will be compared     between the groups. Survival and success rates will be defined in 6, 12 and 24 months.     Survival will be established by Kaplan-Meier survival curve and log-rank can be conducted to     identify as variables associated with as failures over time. Multivariate analysis with the     Cox regression models will be condutcted for the determination of failure predictors. For all     analyzes, the significance value will be adjusted to 5%.   "
16884|NCT03064503|"     In normal ageing, the impact of myocardial fibrosis on myocardial function is unclear as     diastolic function is reported to change according to age. The objective is to explore the     relationship between myocardial function changes, with local (T1 and diffusion) fibrosis     measures with Magnetic Resonance Imaging (MRI) as well as global measures of fibrosis (skin     auto-fluorescence and collagen blood-biomarkers).   "
16981|NCT03063242|"     The study will determine whether administration of sargramostim will improve myeloid     dendritic cell deficiency in various study groups, including healthy subjects and patients     with chronic kidney disease, including those with kidney transplants.   "
16887|NCT03064464|"     Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA), strains of MRSA     that are able to infect otherwise healthy people outside of hospital settings, emerged in the     late 1990s and have recently arisen in many countries around the globe. CA-MRSA strains are     usually distinguished from their HA-MRSA counterparts by the following characteristics:     Firstly, CA-MRSA strains are usually susceptible to non-lactam antibiotics. Secondly, CA-MRSA     harbors type IV and V SCCmec elements, which are shorter than the traditional type I, II, and     III SCCmec elements found in HA-MRSA strains. Thirdly, certain successful clones are     associated with outbreaks of CA-MRSA infections reported in specific geographical locations.     For example, ST1 and ST8 isolates are mostly reported in the USA and Canada, ST80 isolates     are commonly found in Europe, and ST59 isolates are encountered in the Asia-Pacific region.     Notably, all these characteristics have substantial limitations for discriminating CA-MRSA     isolates due to their complex backgrounds. Although there were more and more studies of     CA-MRSA in European countries and the US, few national epidemiological data were available     about China. In this study, we investigated the epidemiological, clinical and molecular     characteristics of CA-MRSA isolates recovered in Chinese hospitals, in order to understand     the changing epidemiology of MRSA in China.   "
16888|NCT03064451|"     The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps     created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate     persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia     compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is     investigational, while the CARTOFINDER™ system is CE marked in Europe.      All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation     procedure for management of their persistent AF will be the target population for screening.     The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided     ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12     months postprocedure.   "
16889|NCT03064438|"     The study evaluates the safety, efficacy and tolerability of ACCU-D1 when applied twice daily     for 12 weeks in adult patients with moderate to severe acne rosacea. Two thirds of     participants will receive ACCU-D1 while one third will receive vehicle control.   "
16890|NCT03064425|"     There is great variability in susceptibility from one person to another, and less than one in     a hundred sexual exposures to HIV results in infection. In addition, some recent trial of     methods to prevent HIV - including vaccines and microbicides - have actually increased HIV     acquisition among trial participants for reasons that we do not fully understand. While we     know that immune differences in the genital lining are an important determinant of whether a     person is infected after a sexual HIV exposure, we don't know enough about these differences     to be able to accurately assess a person's individual HIV risk. Therefore, the development of     safe and non-invasive laboratory tests to estimate a person's susceptibility in the genital     tract would be useful in clinical studies of new HIV prevention tools.   "
16891|NCT03064412|"     Androgens are important sex steroids in women. Androgens influence protein synthesis and     muscle growth, are involved in maturation of the reproductive organs, have a fat reducing     effect , have a negative effect on the serum lipid profile, and may also increase insulin     resistance and coagulation activity. The role of androgens in women is not clear. This study     is aimed at learning about the amount of androgen and its actions in pregnant women. This     study is also looking to see if there are specific patient factors (such as genetics) that     change the amount of androgen and its activity.   "
16892|NCT03064399|"     To study the clinical efficacy of microfracture combined with lateral ligament repairment for     cartilage lesions of talus through the comparison between microfracture with and without     lateral ligament repairment.   "
16893|NCT03064386|"     To compare the clinical efficacy of open reduction and internal fixation (ORIF) with plate     and screw for postieror malleolar fractures.   "
16894|NCT03064373|"     Staphylococcus aureus (SA) is a significant cause of community and hospital acquired     infections. SA is carried by approximately 30% of healthy adults. Similar carriage rates have     been reported in very young infants and newborns. Previous studies have suggested that the     source of SA carriage in young children is SA carried by their mothers. Possible modes of     transmission from mother to child are transmission during passage through a colonized birth     canal, through lactation and/or close contact.      We aim to 1) Define the route of transmission between mother and newborn. 2) Assess the     dynamics of S. aureus carriage during the first years of life and specifically determine risk     factors for becoming a persistent carrier of S. aureus   "
16895|NCT03064360|"     Usual care may not identify subtle clinical changes that precede a major adverse     cardiovascular event (MACE). Therefore investigators will explore the effectiveness of using     biomarkers, patient reported outcomes (PROs), and patient reported informatics (PRIs) as     predictors to a MACE event.   "
16896|NCT03064347|"     This study will evaluate whether enteric-coated nutrients increase some glucose and     regulating hormone levels, glucose tolerance and satiety in overweight and obese individuals     with type 2 diabetes.   "
16897|NCT03064334|"     In order to assess patients' concerns and other quality of life aspects, post-total knee     arthroplasty (TKA) requires further assessment tools, more than controlled experiments     testing defined isolated variables. Qualitative research offers useful methods to explicate     the complexity and deeper meaning of patient experiences and outcomes post-TKA. Qualitative     methods facilitate the collection of in-depth experiences and perceptions from individuals     about a specific phenomenon which, in this case, is outcomes post-TKA. Specifically, a     phenomenological approach allows for the collection of diverse and unique patient experiences     and outcomes post-TKA .      The focus of this project is using focus groups to explore poorly understood areas, such as     outcomes and experiences post-TKA, in order to generate useful findings and hypotheses.   "
16951|NCT03063632|"     This phase II trial studies how well pembrolizumab and interferon gamma-1b work in treating     patients with stage IB-IVB mycosis fungoides and sezary syndrome that has come back or has     not responded to previous treatment. Monoclonal antibodies, such as pembrolizumab, may     interfere with the ability of cancer cells to grow and spread. Interferon gamma-1b may boost     the immune system activity. Giving pembrolizumab and interferon gamma-1b together may work     better in treating patients with stage IB-IVB mycosis fungoides and sezary syndrome.   "
16899|NCT03064308|"     The primary aim of this study is to establish if it is possible for patients who have     undergone major body surgery to complete a home based exercise training program and complete     the assessments required to measure physical and cognitive function. If the investigators can     establish that it is feasible to complete the training and test's then further research can     follow using these methods to determine whether it is possible to improve the physical     function of older patients undergoing major abdominal surgery in the period following surgery     by using a simple exercise regimen that can be carried out at home. By targeting physical     function in this way the investigators hope to determine if it is a method for improving     frailty and well being. In turn it may also have a positive impact on health service     provision.   "
16900|NCT03064295|"     This study hopes to provide significant technical improvement in a Myocardial Blood Flow     (MBF) cardiac magnetic resonance (CMR) quantification technique to address challenges and     technical limitations for MBF CMR. By developing and validating novel techniques to improve     first-pass perfusion (FPP) cardiac MR, we propose to increase diagnostic accuracy by     minimizing false positives and false negatives, allow for better evaluation and accurate     quantification of total ischemic burden and reduce image and motion-induced artifacts.      The broad, long-term objective of the proposed project is to improve the prognosis of     patients with myocardial ischemia caused by coronary artery disease (CAD) or coronary     microvascular dysfunction (CMD).   "
16901|NCT03064282|"     Treatment of patients with prostatic hyperplasia with topical papaverine.   "
16902|NCT03064269|"     This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells     (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.   "
16903|NCT03064256|"     This study compared the changes in the cardiovascular, hemodynamic and metabolic variables of     hypertensive patients who received aerobic physical training with intensity determined by the     protocol of double non-exhaustive efforts (DENE) with that of patients who received routine     outpatient care 12 weeks after Entry into the study. 63 men and women participated in the     study and were allocated in the intervention group (n = 42) and control group (n = 21).The     following were performed: Cardiopulmonary exercise test (TECP) for evaluation of peak oxygen     consumption (VO2peak), oxygen pulse and double product; DENE protocol for the determination     of the intensity of the training. It was obtained the recording of the intervals between     consecutive heart beats (iRR) to evaluate the autonomic modulation of the heart rate. Body     mass index, waist circumference (AC), hip circumference (CQ) and Waist / hip ratio (WHR) were     measured.   "
16904|NCT03064243|"     Apatinib is a kind of innovative medicines approved by China Food and Drug     Administration（CFDA）, which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd.     Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore     Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.   "
16905|NCT03064230|"     The Female Athlete Triad is a medical condition often observed in physically active girls and     women, and involves 3 components: (1) low energy availability with or without disordered     eating, (2) menstrual dysfunction, and (3) low bone mineral density. An early intervention is     essential to prevent its progression to serious endpoints including clinical eating     disorders, amenorrhea, and osteoporosis that can affect the quality of life of these patients     and even compromise the athletic performance.      All patients, aged between 14 and 40 years, who met the inclusion and exclusion criteria,     were prospectively enrolled in this observational study and were divided into two groups:     Athletes agonists (Experimental Group or Group A) and women who do not perform agonistic     sports (Control Group or Group B). In both groups of patients, the investigators administered     two types of questionnaires: a standardized quality of Life questionnaire, validated in     Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert     Panel.   "
16906|NCT03064217|"     Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not     enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth     breaks off at the gum line, or when a crown or filling falls out of a tooth and there is     decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is     done by removing some gum tissue or bone.      After surgery, the area will heal in about three months. Then, making a crown can begin. This     healing period often delays the delivery a final crown. This study is investing a way to make     the final impression at the surgery to expedite the delivery of a final crown.   "
16907|NCT03064204|"     The purpose of this study is to help us understand how HIV and/or Anti-Retroviral Therapy     (ART) may predispose individuals to Obstructive Sleep Apnea (OSA). The traditional risk     factors for OSA are weight and age. However, people living with HIV on ART seem to have OSA     even when they are thin and young. The study involves a detailed physiological sleep study     and an MRI of the head and neck to understand the underlying cause of OSA in those with and     without HIV.   "
16908|NCT03064191|"     Is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium     hydroxide alone as an intra-canal medication in postoperative flare-up in two visits     endodontic retreatment cases   "
16909|NCT03064178|"     This study had the following aims: i. to determine the relationship between anticipated pain     and actual pain experienced following periodontal surgery; and ii. determine the factors that     predict the amount of pain and the amount of pain medication use following periodontal     surgery.      It was hypothesized that experienced pain will be significantly less than anticipated pain.     It was also hypothesized that the following factors will affect pain experienced: sex, type     of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use and     pain pill usage. It was hypothesized that the following factors will affect pain pill usage:     sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status,     supplement use, and actual pain.   "
16910|NCT03064165|"     The study investigates the effect of an obturator nerve block on the postoperative pain and     opioid consumption after total hip replacement.   "
17004|NCT03062943|"     This trial is conducted locally. The aim of this trial is assess the efficacy and a favorable     benefit-risk ratio for nintedanib in the treatment of LAM at the dose of 150 mg bid   "
17784|NCT03052738|"     This study proposes to do a prospective observational cohort study evaluating the quality of     life (QOL) of children with Central Nervous System (CNS) tumors and their families who choose     to self-medicate with marijuana-derived products while undergoing treatment at Children's     Hospital Colorado (CHCO).   "
16911|NCT03064152|"     The aim of this study is to evaluate the impact of a rotational thromboelastometry     (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or     cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for     intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The     utilization of ROTEM® for transfusion management will identify patients who develop early     coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our     hypothesis is that earlier identification and directed therapy of such coagulation changes     will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma,     fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU     admission, and shorten length of hospital stay. A cost analysis will be performed.   "
16912|NCT03064139|"     This study evaluates the feasibility of a mindful walking intervention for management of knee     osteoarthritis. Half of the participants will receive the mindful walking intervention while     the other half will receive education on osteoarthritis management.   "
16913|NCT03064126|"     To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for     treating lesions located in the superficial femoral and proximal popliteal arteries     (SFA/PPA).   "
16914|NCT03064113|"     Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and     completed the follow-up assessments. During each of the four study periods, subjects were     admitted to the clinic on Day -1 and housed overnight until after the last spirometry     measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples     collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after     evaluations.   "
16915|NCT03064100|"     The purpose of this study is to collect data to support decisions made by BioFire regarding     assay development, panel composition, and intended use for the final FilmArray CSI reagent     pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients     under 18 years of age that present with acute fever.   "
16916|NCT03064087|"     The VALHUDES study is a Diagnostic Test Accuracy study that aims to document the clinical     accuracy of hrHPV testing on urine samples, collected under standardised and optimised     conditions, and on two types of vaginal self-samples and compare results with those from     matching samples taken by a clinician.   "
16917|NCT03064074|"     Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People     with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and,     in adult years, hearing loss. OI can range from very severe to very mild. The current     standard-of-care for severe types of OI involves the use of IV medications (bisphosphonates)     and surgery to put rods in bones to strengthen them. These therapies, although often     life-saving, are new and very little is known about their long-term effects on bone and other     body systems.      Transforming growth factor beta (TGF-β) is a protein important in bone formation.     Fresolimumab is an antibody that can silence TGF-β . In studies with mice with OI, it has     been shown that silencing TGF-β can lead to higher bone mass, quality and strength. The     purpose of this study is to determine if fresolimumab is safe in the treatment of OI.   "
16918|NCT03064061|"     The primary objective of this study is to evaluate the impact of a session of virtual reality     (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate     following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to     infertility happens frequently and over time, can become stressful for our patients. This     level of stress influences the effect of the infertility treatment. Reducing anxiety levels     could promote the ability of the patients to face this stress and promote a greater chance of     pregnancy in that context.   "
16919|NCT03064048|"     This is a study involving a dietary supplement. Patients with argininosuccinate lyase     deficiency (ASLD) will be randomly assigned to receive either a nitric oxide dietary     supplement or placebo for 24 weeks, and then crossed-over to receive the other treatment for     24 weeks. The investigators will assess the effects of the supplement in domains of general     cognition, memory, executive functioning, and fine motor functioning in individuals with     ASLD.   "
16920|NCT03064035|"     The goal of this study is to determine if a fixed dose of 4-factor prothrombin complex     concentrate (4FPCC) is as effective as the current standard of care. 4FPCC is used to reverse     the effects of warfarin when a patient has emergent bleeding. The investigators hope that     this study will help doctors treat patients quicker in the future. In addition, it may be     cheaper for patients and hospitals. This is the same medication the doctor would use to     reverse warfarin's effects, but at a lower dose.      Hypothesis: A fixed dose of 4FPCC will be comparable to FDA-approved variable dosing for     reversal of warfarin-induced anticoagulation (defined as an international normalized ratio     [INR] ≤ 1.5) in patients with an INR ≥2 experiencing an emergent bleed or requiring emergent     surgery.   "
16921|NCT03064022|"     The purpose of this study is to improve health professionals understanding of preterm infant     growth patterns, and to determine if early growth patterns predict risks of adverse metabolic     outcomes.   "
16922|NCT03064009|"     To determine if there is a relationship between people with open fractures and the season and     location of where the injury occurred and the infections they develop   "
16923|NCT03063996|"     The primary aim of this study is to determine if the insertion of a peripheral Internal     Jugular (IJ) catheter is faster than a standard of care intravenous (IV)access in patients     with difficult access. The secondary aims of this study examine patient discomfort between     standard IV insertion vs. peripheral IV insertion as well as a comparison of complication     rates between the two methods of insertion. Support for the peripheral IV procedure could     provide an option for the thousands of Emergency Department (ED) patients who daily encounter     the situation of difficult IV access and the numerous needle pokes that accompany it. Using     this procedure may result in greater patient satisfaction and reduced complication rates.   "
16924|NCT03063983|"     Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective     against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of     maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with     high grade, operable, metastatic osteosarcoma (OST) of the extremities. The primary end point     is event-free survival (EFS) from randomization   "
47788|NCT02660112|"     This 24-week study will test the safety and effectiveness of synthetically produced (+)     Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.   "
16925|NCT03063970|"     Stroke is the major cause of complex adult disability in the UK. Upper limb impairment     contributes to disability and fewer than 15% of survivors regain full arm and hand function     by 6 months. Consequently, many stroke survivors have difficulties with activities of daily     living where good upper limb and hand function is required. Upper limb impairment also     predicts quality of life and independent functioning after stroke. It is therefore vital that     effective therapeutic interventions to improve upper limb recovery are found.      Various therapeutic interventions to improve arm recovery after stroke have been proposed,     however although effective in some circumstances, many have been proven as unacceptable and     unfeasible in usual rehabilitation practice. The aim of this study is to evaluate the     acceptability and feasibility of Dynamic Lycra Orthoses (DLO), as an adjunct to usual UL     rehabilitation and to examine the magnitude, direction and variability of any effects on     upper limb impairment and functioning.      This inexpensive, commercially available, CE marked, tailor-made lycra sleeve garment is worn     for up to 8 hours a day and during rehabilitation therapy. The DLO has not been extensively     studies in stroke rehabilitation, but existing evidence suggests that the garment may enhance     sensory feedback and correct upper limb movement and positioning, facilitating conditions for     recovery without the need for direct therapist supervision. It may therefore augment the     effects of standard dose of Occupational Therapy and Physiotherapy, and self-directed     practice.      This is a feasibility, randomised, controlled trial. Using 2:1 randomisation, We will recruit     and randomise 60 participants with mild, moderate and severe UL impairment who have been     admitted to Ninewells Hospital or Perth Royal Infirmary, Tayside, Scotland with a stroke     affecting the upper limb to receive usual care or usual care plus the DLO. The DLO will be     worn daily for up to 8 hours over 8 weeks. A blinded rater will collect outcomes data     examining upper limb functioning, strength, dexterity, sensation, use of the arm for daily     functioning and quality of life at the end of the intervention and at follow-up eight weeks     later. Data relating to duration and frequency of DLO wear, proportion of eligible     participants, and those willing to be randomised, drop-outs and losses to follow-up will also     be recorded to assess feasibility of a full-scale trial.   "
16926|NCT03063957|"     The goal of this study is to establish a prospective observational cohort of adult patients     with microscopic colitis and collect clinical information and specimens over the course of     their treatment. This information will be used in order to establish a patient registry with     detailed clinical data and a specimen repository for future research as well as to     specifically identify genetic and molecular characteristics associated with microscopic     colitis.   "
16927|NCT03063944|"     This phase I trial studies the side effects and best dose of STAT inhibitor OPB-111077 when     given together with decitabine in treating patients with acute myeloid leukemia that does not     respond to treatment or is newly diagnosed and ineligible for intensive chemotherapy. STAT     inhibitor OPB-111077 and decitabine may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.   "
16928|NCT03063931|"     In breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if     the magnesium administered for 6 weeks starting two weeks before the surgery induces a     decrease of pain intensity one month post-mastectomy compared to the placebo group.   "
16929|NCT03063918|"     This pilot clinical trial studies how well personalized dietary intervention works in     managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer     survivors. Personalized dietary intervention may help people understand bowel symptoms,     identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation     based on food triggers, and coach on healthy diet recommendations after cancer treatment.   "
16930|NCT03063905|"     Evidence to support the effectiveness of ongoing opioid therapy for the treatment of chronic     non-malignant pain is lacking. In fact, data suggest that patient outcomes improve when     tapered off opioid analgesics. To better understand the role opioid therapy plays in the     experience of pain, we will study measured pain sensitivity in opioid dependent patients over     the course of and 3 months following a standardized opioid taper. By isolating the effect of     opioid taper in patients without pain, preliminary evidence of effect size can be used to     guide clinicians treating patients with chronic pain.   "
16931|NCT03063892|"     Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty     to reduce the need for intraoperative and postoperative blood transfusions. Limited research     is available on its use in hip fracture patients. We hypothesize that the use of TXA     preoperatively, perioperatively, and postoperatively will decrease blood loss and need for     blood transfusion postoperatively.   "
16932|NCT03063879|"     Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal     failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although     no particular adverse event has been linked to this metabolite sofosbuvir is not recommended     for patients with renal failure mainly because of lack of data. Nevertheless there are     anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This     study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir     and daclatasvir in treating hepatitis C in 100 patients with renal failure.   "
16933|NCT03063866|"     Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver     disease. It requires variable degree of sedation ranging from minimal sedation to general     anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.      In conscious sedation, patients are able to make purposeful responses to auditory and tactile     clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation,     patients respond only to painful stimuli, and airway support is frequently required. At the     level of general anesthesia, patients are unresponsive, and airway support is mandatory.   "
16934|NCT03063853|"     The optimal choice of skin closure at cesarean delivery has not yet been determined. This     study aim to study the wound complications and scar healing after Surgical staples removal at     postoperative day 4 and day 8 .      A randomized control trial.   "
16935|NCT03063840|"     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is     one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in     Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than     8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients     present with advanced or unresectable disease. In contrast, small liver cancers can be cured     with an appreciable frequency. Five-year disease-free survival exceeding 50% has been     reported for surgical resection, and for the inoperable patients who do not have vascular     invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an     alternative curative therapy. However, the main drawback of RFA is its limitation to tumor     size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels,     could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by     higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.   "
19817|NCT03026166|"     The purpose of this multicenter, Phase 1/2, open-label, study is to assess the safety and     efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab     and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).   "
16936|NCT03063827|"     This study investigated the changes in urothelial dysfunction and sensory protein expression     in the bladder urothelium with time after onabotulinumtoxin injection in spinal cord injured     (SCI) patients. The investigators planned to enroll 30 chronic SCI patient with neurogenic     detrusor overactivity and urinary incontinence were treated with a single injection of 200 U     onabotulinumtoxinA at the detrusor. Video urodynamic studies and bladder mucosal biopsies     were performed at baseline, 3 months, and 6 months after treatment. Bladder tissues will be     investigated for urothelial barrier and inflammation proteins as well as sensory proteins by     Western blotting, between SCI patients and 10 controls, as well as successful and failed     treatment groups. This study will explore the therapeutic efficacy of a single injection of     200 U onabotulinumtoxinA on neurogenic detrusor overactivity and the changes of urothelial     sensory proteins in SCI patients with successful and failed treatment outcome.   "
16937|NCT03063814|"     Therefore, the aim of the present study was to evaluate neuromuscular characteristics     observed during a single bout of selected and validated injury preventive exercises     instructed by an app (in accordance with 'Get set - Train smarter') versus gold standard     instruction, supervision and feedback provided on-site by an expert. The present evaluation     targets a population of female football and handball players without any previous exposure to     injury prevention training.   "
16938|NCT03063801|"     Surgeries of heart disease in adulthood can happen in two specific contexts:        -  either for an asymptomatic anomaly, possibly coupled with the onset of symptoms later in          life and tardily diagnosed and surgically managed        -  either for a malformation treated in childhood and requiring a new intervention in          adulthood. In recent years, the number of adult patients with congenital heart disease          has been steadily increasing. Advances in diagnostic techniques and surgical treatments          have enabled many children to reach adulthood. The number of these patients is now          higher than the number of children with congenital heart disease. The number of these          patients having had surgery in adulthood is also increasing.      Congenital cardiopathies are numerous, ranging from simpler pathologies such as     inter-auricular or inter-ventricular communication, to much more complex pathologies such as     situations of univentricular hearts. The surgical treatments of these congenital heart     diseases are classified into three groups: initial palliative surgery, initial curative     surgery or iterative surgery. Palliative surgery aims to improve the clinical tolerance of     the patient to the conditions of his pathology or to prevent complications. The curative     surgery restores the physiological circulation, the iterative surgery treats a complication     or a degeneration appearing after a curative surgery.      Patients undergoing cardiac surgery frequently receive blood products transfusions during the     preoperative, intraoperative, or postoperative periods. Several observational studies have     shown that in cardiac surgery, the transfusion of blood derivatives is associated with an     increase in post-operative morbidity and mortality.      The objective of this study is to analyze the predictive factors of transfusion in congenital     patients operated in adulthood at Brugmann University Hospital, depending on the type of     surgery applied (palliative, curative or iterative). The secondary objective will be to     assess whether there are any differences with the predictive factors identified in     non-congenital patients undergoing cardiac surgery, which could potentially alter the     transfusion approach in congenital patients.   "
16939|NCT03063788|"     Radiolabelling broadly neutralizing anti-HIV antibody 3BNC117 with a Copper-64 radio isotope     for infusion into people with HIV followed by MRI/PET scanning to detect HIV in vivo.   "
16940|NCT03063775|"     It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering     comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If     so, this would provide a substantial benefit to the patient as the second intervention on the     palate and the subsequent morbidity of the donor site is omitted.   "
16941|NCT03063762|"     This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess     the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic     activity of RO6874281 in combination with atezolizumab with/without bevacizumab in     participants with unresectable advanced and/or metastatic RCC. The study will consist of     dose-escalation part and extension part.   "
16942|NCT03063749|"     To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting     Coronary Stent System in a real-world more-comer population.   "
16943|NCT03063736|"     The primary objective of this pilot study to evaluate the safety of low dose Entolimod in     normal, healthy, non-patient normals. This clinical trial in 40 normal humans compares a     single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum with or     without entolimod. Subjects will be randomized to: Td alone (n=15) and Td+ entolimod (n=25).     The investigators expect that Td + entolimod will double the anti-TT and anti-diphtheria AB     levels over Td alone.   "
16944|NCT03063723|"     Recently,surprisingly and unexpectedly increased aggressiveness and high rates of HCC     recurrence (28%(16/58) and 29%(17/59), respectively) have been reported in patients who     cleared HCV with DAAs after achieving a complete response to resection or local ablation     within only 6 months of therapy. The authors hypothesized that the rapid eradication of HCV     and control of liver inflammation would impact anti-tumoral immune control, which in turn     might contribute to the neoplastic cells proliferation. Conversely, three independent     prospective French cohorts failed to reveal an increased risk of HCC recurrence after DAAs     treatment in CHC patients after receiving curative cancer treatments.Although the impact of     DAAs treatment on the rate of HCC occurrence or recurrence still remain unclear, it would be     more important to pay attention to the immunological changes of CHC patients treated with     DAAs.Up to now, little was known about the immunological changes of chronic hepatitis C (CHC)     patients treated with direct-acting antiviral agents (DAAs), here we try to explore the     effect of antiviral treatment of CHC patients with DAAs on the frequency of monocytes, NK     cells and cytokines that promote their activation.   "
16945|NCT03063710|"     This is a single-arm, open label, expanded access program to provide access to olaparib     tablets for relapsed high-grade epithelial ovarian cancer patients (including patients with     primary peritoneal and / or fallopian tube cancer) with BRCA mutations (documented mutation     in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious [known or     predicted to be detrimental/lead to loss of function]) who have responded following platinum     based chemotherapy.      Patients may continue to receive study treatment until disease progression as assessed by the     investigator according to local standard clinical practice or any other discontinuation     criteria are met.   "
16946|NCT03063697|"     The purpose of this study is to Evaluate the Safety of DILATREND SR Cap. in Korean Patients     with Essential hypertension, Chronic stable angina and Congestive heart failure for 52 weeks.   "
16947|NCT03063684|"     The study will examine the effects of fractional/pixel CO2 laser treatment in vaginal atrophy     and in vulvar lichen sclerosus by means of histological and immuno-histochemical     characterization of the epithelial layers and markers of tissue aging. The tissue     characterization will be performed by biopsies of the vaginal or vulvar tissue at three     different points of time: prior to treatment, two weeks after the third and last treatment,     and one year after the last treatment.   "
16954|NCT03063593|"     Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study     Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group     Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with     INFINITY® Total Ankle System Number of Subjects 500 with 10 sites   "
16955|NCT03063580|"     Primary Objective:      To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its     metabolite in healthy male and female subjects.      Secondary Objectives:        -  To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin          400 mg, alone and with rifampicin, in healthy male and female subjects.        -  To assess the safety and tolerability of single dose sotagliflozin with and without          rifampicin in healthy male and female subjects.   "
16956|NCT03063567|"     Obstructive sleep apnea (OSA) is a prevalent disease, and one that is associated with     significant negative impact on long-term survival. There is convincing evidence that     treatment of OSA can improve outcome in patients with cardiovascular disease, improve blood     pressure and blood glucose control, and improve the overall metabolic syndrome. Treatment is     usually with continuous positive airway pressure (CPAP). However, many patients face problems     with their CPAP interfaces, affecting their compliance and response to treatment. Proper mask     fit is important in decreasing air leak and increasing comfort, thus leading to better     compliance. Currently, the choice of interfaces depends mainly on the experience of the sleep     disorder unit (SDU) technicians. Unsuitable choice of interface not only affects response to     treatment but also increases medical costs when interfaces need to be replaced to better     fitting ones. It is thus important to develop selection criteria to objectively guide the SDU     technicians in choosing the suitable interfaces. The objective of this study is to study the     facial profile of patients and look for predictive indices that can be used to objectively     guide the choice of appropriate interfaces. Frontal and side profile photographs of patients     will be taken and facial measurements will be recorded. Patients will then be given a one     monthly trial of each of the 3 interfaces (nasal masks, oronasal masks, nasal cushions) in a     randomised order. The patients' subjective perception of each of the interface will be     assessed and patients will nominate their preferred interface at the end of the trial. The     amount of leak and the hours of adherence for each type of interface will also be analysed. A     multinomial logistic regression analysis will then be done to look for facial measurements     that will predict the interface that patients will be most satisfied with.      Hypothesis That measurement of facial structures and clinical features will be able to     predict the best-fit CPAP interface for each patient.      Study Objective        -  To determine anthropometric facial measurements and clinical factors important in          achieving a good interface fit for each patient        -  To derive a prediction rule or equation that will be able to accurately predict which          interface a patient should be prescribed   "
16957|NCT03063554|"     This Endoscopic Ultrasound guided Biliary Drainage (EUS-BD) vs. Endoscopic Retrograde     Cholangiopancreatography (ERCP-TP) trial (BILPAL) is a randomized controlled multicenter     trial that will provide evidence whether or not traditional ERCP biliary drainage is to be     performed in patients with obstruction in bile duct due to unresectable pancreatic head or     periampullary tumor.   "
16958|NCT03063541|"     Purpose of this study is to assess the hypothesis that a strategy with acetylsalicylic acid     (ASA) 100 mg/day, intensive blood pressure treatment (targeted systolic blood pressure below     120 mmHg), and a blood pressure measuring device reduces the risk of aneurysm rupture or     growth compared with standard care (i.e. no ASA, blood pressure management according to     standard blood pressure management, no blood pressure measuring device)   "
16959|NCT03063528|"     This proposal is part of a broader research agenda that posits healthy gestational weight     gain (GWG) may be achieved through behavioral intervention and may potentially reduce adverse     maternal and infant health outcomes associated with excessive weight gain during pregnancy.     The purpose of this study is to examine the use of a mobile application (mobile app) and     mobile website for encouraging and maintaining healthy behaviors such as healthy eating,     regular exercise, and stress management and reduction during pregnancy. The study will     include collaborative group-based health behavior challenges for pregnant women living in the     United States. The study will test the effectiveness of the intervention on improving     maternal health behaviors. The proposed research project will examine if an intervention     targeting healthy eating and exercise leads to significantly less weight gained during     pregnancy versus a comparison group that receives stress reduction and management content.   "
16961|NCT03063502|"     This study evaluates how urine handling conditions can affect the concentrations of ~1,000     urine metabolites and attempts to quantify the degree of attenuation and/or potential bias in     epidemiologic associations that may result from less than optimal sample handling conditions.   "
16962|NCT03063489|"     Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat     Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers   "
16963|NCT03063476|"     This sub-study aims to assess the effect and breakdown of lysine administration, specifically     examining whether it leads to increased plasma 2-AAA in healthy humans.   "
18135|NCT03048149|"     This study is retrospective. It focuses on hazelnut allergic patients with a clinical history     and a positive specific immunoglobulin E (sIgE) against hazelnut and its recombinants that     have followed a hazelnut oral tolerance induction at the allergy Unit of Saint Vincent     Hospital of Lille (France) since 2011.   "
16965|NCT03063450|"     The UK has the highest incidence of mesothelioma. The incidence has risen by 497% since the     late 1970's and is increasing worldwide due to continued mining and use of asbestos. For     patients with mesothelioma who have relapsed after taking pemetrexed and cisplatin, there is     currently no standard treatment, making this an urgent unmet need. Recent trials in this area     have not found an effective treatment that improves overall survival.      Following a debate in the House of Lords, a national survey assessing the research priorities     in mesothelioma found that 'exploiting the potential of immunotherapy' was a top priority.     This trial was designed in response to that survey. It uses the immunotherapy agent nivolumab     which blocks programmed cell death 1 (PD-1) receptor on activated T-cells (a type of white     blood cell forming part of the immune system). Early research has found a dependency of     mesothelioma on the PD-1 checkpoint. By attaching to PD-1, nivolumab blocks its action     (checkpoint inhibition), preventing it from turning off the T-cell, and therefore allowing     the immune system to work. PD-1 checkpoint inhibition has revolutionised the treatment of     melanoma and it is hoped to be as effective in mesothelioma.      This trial is a randomised, double blind placebo controlled trial of patients with     mesothelioma who are third relapse following a platinum based chemotherapy treatment.     Patients will be randomised in a 2:1 ratio (nivolumab: placebo).      336 patients will be recruited from 25 UK centres over a four-year period with the last     patient having a minimum of 6 months follow up. All patients will be on treatment for 12     months unless they progress or withdrawal prior to this. Clinic visits will occur every 12     weeks, mirroring standard care. Data following progression will be obtained from the NHS     Information Centre.   "
16967|NCT03063424|"     The diagnosis of exercise-induced bronchospasm (EIB) is difficult. The metacholine challenge     test is not enough specific for the diagnosis of EIB. The exercise challenge test on a cycle     ergometer is often use to diagnose this condition. This test has very high specificity, but     not enough sensibility because the ventilation achieved during this test is often not big     enough to induce a bronchospasm, especially in trained athletes. Eucapnic voluntary     hyperventilation (EVH) is the recommended test of the Olympic National committee to establish     the diagnosis of EIB, but there are no study comparing the sensibility and specificity of the     cycle ergometer challenge test and the isocapnic hyperventilation in an establish population     of asthmatics. The investigators assume that the sensitivity and specificity of EVH are     higher than those of the cycle ergometer for the diagnosis of EIB in a population of     asthmatics with symptoms suggestive of bronchospasm on exertion. In a population of     asthmatics with exercise symptoms, what is the sensitivity and specificity of EVH and     exercise challenge on a cycle ergometer for the diagnosis of EIB?   "
16968|NCT03063411|"     This study will test whether a short training program - designed to improve memory and     attention skills - will benefit mathematical reasoning in preschoolers from a range of     socio-economic backgrounds. The investigators will test how long any benefits last for and     whether any intervention effects are greater for children from disadvantaged backgrounds. The     aim is to test interventions that aim to close the achievement gap by improving skills known     to underpin academic skills, at an age children may benefit most from training.   "
16969|NCT03063398|"     This study is a proposed a comprehensive prospective assessment of exocrine pancreatic     insufficiency (EPI), nutritional status, and quality of life (QOL) during the early     re-feeding phase, at 3 months, and 12 months following an AP attack.   "
16970|NCT03063385|"     Latino adolescents are at high risk for HIV/AIDS, other sexually transmitted infections     (STIs), and unintended pregnancies. Puerto Rican adolescents, in particular, experience     disparities in these areas, yet few adolescent and even fewer parent interventions have been     developed to address these important issues with this underserved population.     Parent-adolescent programs are an effective approach to reduce adolescent sexual risk     behavior and associated negative consequences. A web-based parent communication intervention     provides an opportunity to strengthen and enhance programs that are designed for adolescents     by providing additional support for safer sex decisions, and to increase parents' access to     sexual health education programs by decreasing barriers that keep them from participating in     these interventions (e.g., low cost, can be viewed privately, at parents convenience,     minimizes competing time with work and family). The purpose of this proposed study is to     evaluate a brief theoretically informed (i.e., Ecodevelopmental Theory, Theory of Reasoned     Action/Planned Behavior, Social Cognitive Theory 1-6), culturally appropriate, and     linguistically tailored web-based parental communication program, Cuídalos (Take care of     them), designed to improve parent-adolescent sexual communication and reduce adolescent     sexual risk behavior. Recent findings from an NIH funded R21 randomized control trial (RCT)     testing a brief computer-based version of the Cuídalos program indicated that the program     increased parent-adolescent general communication and sexual risk communication with English     and Spanish speaking U.S. Latinos. Further, despite limited or no previous computer use,     parents reported they liked and learned from the program, and that it was easy to use and     accessible.   "
16971|NCT03063372|"     Medical students and residents have high rates of mental distress and burnout related to the     intellectual and time demands of their training. Research shows that physiological stress on     the body can be a result of fatigue and high stress work, and is associated with experiences     related to mental distress. Pomegranate is a fruit that is known to contain a variety of     antioxidant substances that can reduce physiological stress. This study will look at the     potential for pomegranate supplementation to reduce physiological stress and improve     well-being in medical students and residents.   "
16972|NCT03063359|"     Acute tramatic pain is one of main reasons for consultation in pediatric emergency     departments.      To manage pain quickly and effectively must be a primary outcome of the emergency department.     However, pediatric emergency department are sometimes criticized for inadequate and delayed     initiation analgesia . Indeed, several studies have shown the inadequacy between the     intensity of the pain evaluated by the care team and the therapeutic management of it.      The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have     few side effects and can be administered quickly and painlessly. That's why, the main outcome     of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs     morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency     department.   "
16973|NCT03063346|"     Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused     by the bodies' lack of ability to recover between training. In addition, during high     intensity training reactive oxygen species are formed up to 20 fold compared to resting     values. This causes increased muscle tissue damage after intense exercise, which slows down     recovery. Improving recovery may increase an athlete's ability to reach higher training     volumes resulting in establishing a higher performance plateau.      It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due     to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate     may have positive effects on strength recovery.   "
16974|NCT03063333|"     Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to     reduce pain in people with chronic tension-type headache and experimental pain in healthy     volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain     post-hypnosis is unknown.      The aim is to investigate the durational effect of a single session of coping-oriented     hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a     longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or     may be used in conjunction with lower medicine dosages.      Methods: 75 patients with spinal cord injury and pain is randomized into one of three     conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current     treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing,     anxiety and depression is assessed before intervention and over a period of 14 days     post-intervention.   "
20993|NCT03010800|"     This study will test the acute efficacy of an investigational device (Yoni.Fit) in a clinical     trial of women with incontinence in a standardized set of challenges performed with and     without the device in place.   "
16975|NCT03063320|"     A 3-period randomized cross-over, controlled feeding study will be conducted to determine the     effect of chronic spice consumption on postprandial vascular function. Participants will     consume three test diets containing different amounts of spice. Each treatment period will     last for 4 weeks. After each diet period a meal test will be conducted. Participants will     consume a meal with a spice content corresponding to the diet period they have just     completed. Endothelial function will be measured at 2 and 4 hours after meal consumption.     Blood samples will also be taken during the 4 hours after meal consumption for measurement of     lipids, immune and inflammatory markers.   "
16976|NCT03063307|"     The present study aims to evaluate, through a controlled clinical randomized study,the     effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars     when compared to atraumatic restorative treatment.   "
16977|NCT03063294|"     The Coordination Toolkit and Coaching (CTAC) project aims to disseminate strategies for     coordination of care for high-risk Veterans via an online toolkit, while evaluating the     benefits of adding a distance-coaching strategy to assist sites with deploying the toolkit's     tools. The project's focus is on care coordination across outpatient settings.      This multi-site project provides: 1) An online toolkit to support better care coordination     for vulnerable patients visiting primary care, 2) Random assignment of participating clinics     to either a toolkit or a combined toolkit/distance coaching strategy, and 3) A quality     improvement approach with plan-do-study-act cycles of improvement, designed to support     clinics in a locally initiated effort.      The project is recruiting clinics with the goal of improving Veteran experience of care (as     measured by a survey called the Hassles Scale), communication and coordination between     primary care providers and specialists, and use of acute care services.   "
16978|NCT03063281|"     Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the     production of multiple autoantibodies. The prevalence and significance of antibodies against     Ficolin-2 have not been yet investigated. The aims of this study were to determine the     prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential     as diagnostic and/or prognostic biomarkers in SLE.      This study is a secondary phase of a serum sample analysis done in early 2015 in order to     determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously     declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0).      In this retrospective study, clinical data were obtained from medical files and blood samples     were selected from preexisting biological collection. SLE patients (n=165) were informed and     did not objected, they were matched to healthy controls (n=48). Disease activity was     determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in     sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2,     anti-dsDNA and anti-C1q antibodies levels.      The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p<0.0001). The     presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q     and anti-dsDNA antibodies.      Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies     demonstrated higher specificity than any other traditional biomarker.      These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for     the diagnosis of active nephritis in SLE patients.   "
16979|NCT03063268|"     The goal of this project is to develop and evaluate a novel, electronic informed consent     application for research involving electronic health record (EHR) data. In response to NIH     RFA-OD-15-002, this study addresses research using clinical records and data, including the     issues of the appropriate content and duration of informed consent and patient preferences     about research use of clinical information. This study will design an electronic consent     application intended to improve patients' satisfaction with and understanding of consent for     research using their EHR data. The electronic application will provide interactive     functionality that creates a virtual, patient-centered discussion with patients about     research that uses EHR data. Also, to correct potential misconceptions and increase     informedness, the application will present trust-enhancing messages that highlight facts     about research regulations, researcher training, and data protections. This study (Specific     Aim 2 of the linked study protocol) will compare the effectiveness of the interactive,     trust-enhanced consent application to an interactive consent and standard consent (no     interactivity, no trust- enhancement) using a randomized trial of the three consents with 600     adults in a network of family medicine practices. Primary outcomes will be satisfaction with     the consent decision and understanding of the consent content. This application will allow     patients to learn more about clinical research and make informed choices about whether or not     they want their health records and data to be used for research. This first phase of this     project (IRB#:201500678) was innovative because it created a virtual, patient-centered     discussion about research using EHR data. Moreover, this project produced a consent     application that clinicians and researchers will use in this phase (Phase two) of the trial     as an ethically sound and practical tool for consenting patients, in a clinical setting, for     research involving EHRs. Overall, this study will improve understanding of how to best give     patients information about research that uses their health records and data. With this     understanding, this study will develop a new computer application that patients can use in     their doctors' offices. This application will allow patients to learn more about clinical     research and make informed choices about whether or not they want their health records and     data to be used for research.   "
16980|NCT03063255|"     Patients diagnosed with posterolateral bladder tumors will be invited to participate in the     study. Subjects will be randomized to receive an ultrasound-guided obturator block or a     neuromuscular blocking agent after the induction of general anesthesia in an attempt to block     the obturator reflex during surgery.   "
18136|NCT03048136|"     A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent     Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab   "
16982|NCT03063229|"     Islet transplantation may be appropriate in up to 10% of adults with Type 1 diabetes who     suffer repeated episodes of hypoglycaemia with severely impaired awareness of hypoglycaemia     (IAH) (1). Our Scotland-wide islet transplant programme performed its first transplant in     February 2011 and 30 islet transplants have followed in 18 recipients. Following islet     transplantation we have observed improved glycaemic control in all subjects. When metabolic     control is improved with exogenous insulin, weight gain is common (2). In our transplant     recipients significant reductions in bodyweight and fat mass with no significant reduction in     total caloric intake pre- versus post-transplantation has been observed. We hypothesise that     energy expenditure is increased post-transplantation leading to weight loss and diminished     fat mass. The mechanisms that may be implicated include increased activity energy     expenditure, increased resting energy expenditure (REE) and, or, increased post-prandial     thermogenesis (PPT= the energy expended after a meal) secondary to increased portal     circulation of insulin being partially or fully restored, and diminished circulating systemic     insulin concentrations with a decreased propensity for storing fat. The aim of this study is     to understand the mechanism of weight loss and body compositional changes by detailed     examination of energy intake and energy expenditure in transplant recipients along with     control subjects listed for insulin-pump therapy and glucose tolerant controls. These     detailed studies are lacking in islet transplantation and are important as they will reveal     how physiology is altered post-transplantation, if peripheral hyperinsulinaemia (insulin-pump     subjects and pre-transplant subjects) negatively affects energy expenditure and how     quantitative measures such as activity energy expenditure, diet and quality-of-life measures     such as fear of hypoglycaemia alter post-transplant. This will lead to the improved     management of patients with hypoglycaemia and IAH.   "
16983|NCT03063216|"     The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery     using a large-scale and comprehensive database of pediatric cataract patients, including     congenital and traumatic cataract. We will further investigate into the various genetic and     environmental factors that may contribute to the pathogenesis of pediatric cataract.   "
20994|NCT03010787|"     A multi-part study to investigate the safety, tolerability and local and systemic     pharmacokinetics of V565   "
16985|NCT03063190|"     Restless leg syndrome (RLS) is sleep disorder characterized by an unpleasant feeling in the     lower limbs, which can be accompanied by paresthesias, and need for urgent movement of the     legs. Its diagnosis is clinical, based on an International Committee of the Study of RLS     (International Restless Legs Syndrome Study) questionnaire. Its prevalence is about 5-15% in     the general population, being twice as frequent in women and with a tendency to increase     incidence with aging. In the chronic kidney disease (CKD) population, mainly in patients on     dialysis, the prevalence increases by up to 70%. Vitamin D deficiency is associated with RLS     and active vitamin D supplementation seems to improve RLS and severity. It is seems, studies     on the role of vitamin D supplementation in CKD population are missing. The     clinical-scientific hypothesis of this study is that replacement of vitamin D     (cholecalciferol) will improve the symptoms of RLS. As parathyroidectomy can relieve RLS, the     aim of researchers is to randomize patients with CKD on dialysis to receive cholecalciferol     or placebo in 2 distinct groups: secondary hyperparathyroidism and adynamic bone disease.   "
16986|NCT03063177|"     This study evaluate the relationships between spinal manipulative therapy dosage (speed and     peak force), the resulting modulation of thoracic spinal stiffness and changes in the     clinical status in participants with chronic thoracic pain. Participants will attend four     sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of     three different spinal manipulative therapy dosages based on their group assignment and     preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will     include spinal stiffness measurement and clinical status evaluation through questionnaires.   "
16987|NCT03063164|"     Comparing LASIK outcomes using two femtosecond lasers   "
16988|NCT03063151|"     The aim of the study is to investigate the capacity of post-stroke individual (study group)     to modulate their EMG muscle activation pattern (MAP) compared to healthy individuals     (control group), and to correlate these capacities with their motor impairments. Twenty     post-stroke individuals and 12 healthy individuals will participate in this study. each     participant will carry out hand-reaching movements in multiple directions, monitored by an     EMG device. The modulation of the EMG signal will be compared between groups in terms of     EMG-MAP and in terms of muscle-synergies. Additionally the MAPs and synergies of the study     group will be correlated with their Fugl-Meyer (FM) assessment scores. Analysis of the muscle     synergies underlying the EMG signal will be carried out by the Non-negative Matrix     Factorization (NMF) algorithm.   "
16989|NCT03063138|"     The aim of the study is to evaluate the intra- and inter-rater variability of wound     measurements using the 3D camera and to compare with standard measurement methods (2D image     method and gel injection). Forty-eight patients with wounds of various sizes are measured by     four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and     once by gel injection into wound cavity by two clinicians.   "
16990|NCT03063125|"     The purpose of this study is to examine the relationship between testosterone level changes     around the time of radical cystectomy.   "
16991|NCT03063112|"     The study compares between the efficacy, safety and impact on the quality of life of     radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic     nerves in the management of refractory pain which developed in patients suffering from upper     abdominal cancer.   "
16992|NCT03063099|"     A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis     receiving the ReNu™ Hip Injection.   "
16993|NCT03063086|"     The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a     fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the     respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this     study will complement lung function data obtained in the pivotal QVM149 phase 3 program by     assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing     interval of 24 hours.   "
16994|NCT03063073|"     The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by     the infraclavicular block approach and the intercostal abdominis plane blocks . Many     additives were used in combination with local anesthetics in Pecs block to prolong the     postoperative analgesia (fentanyl, dexmedetomidine).   "
17026|NCT03062657|"     This clinical study will assess the metal concentrations present in the blood serum of     patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous     cervical levels from C3-C7. The information obtained from this clinical investigation will be     used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™     Cervical Disc implanted at two contiguous levels.   "
16995|NCT03063060|"     Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and     becoming a major area of research.      Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but     the impact of vitamin D deficiency remains uncertain.      Since results so far were inconclusive, the goal in this study is to significantly determine     the relation between those two factors.      This study is the first to deal with this issue through patients who underwent total     thyroidectomy that was performed by the same surgeon and the same surgical technique.      A retrospective evaluation study of patients who underwent total thyroidectomy at the head     and neck unit of the Otorhinolaryngology department at our institution between January 2013     and October 2016.      A total number of 60 patients underwent total thyroidectomy with available vitamin D levels     before surgery, as well as pre and post-operative PTH and calcium levels.      Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration     before surgery.      All patients were operated by the same surgeon -Dr. Galit Avior-, with the same surgical     technique.      The study involves access to the patients files and admission reports. In addition the     investigators would like to be able to call the patients in order to ask them whether Vitamin     D deficiency was corrected or not before their surgery, and If it was corrected then when     exactly.   "
17035|NCT03062540|"     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose     study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg     tablets)—a sublingual formulation of cyclobenzaprine. Following successful screening and     randomization, eligible patients will have a telephonic visit at week 2 and then return     regularly to the study clinic for monthly visits for assessments of efficacy and safety.   "
16996|NCT03063047|"     This study will evaluate exposure to tar and nicotine from two menthol cigarette products     and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette     products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt     after smoking the cigarette.      Other purposes of this study are to:        -  Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels          found in users after smoking each of two different cigarettes.        -  Find out the daily mouth-level exposure to cigarette tar and nicotine from smoking          each of two different cigarettes in adult smokers.        -  Determine if certain measures of nicotine dependence change based on the type of          cigarette smoked        -  To compare product liking and intent to use it again.   "
16997|NCT03063034|"     This study will evaluate exposure to tar and nicotine from two menthol cigarette products     and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette     products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt     after smoking the cigarette.      Other purposes of this study are to:        -  Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels          found in users after smoking each of two different cigarettes.        -  Find out the daily mouth-level exposure to cigarette tar and nicotine from smoking          each of two different cigarettes in adult smokers.        -  Determine if certain measures of nicotine dependence change based on the type of          cigarette smoked        -  To compare product liking and intent to use it again.   "
16998|NCT03063021|"     Retinitis Pigmentosa (RP) is a devastating eye disease and at present there are no known     treatment options that can alter the rate of vision loss. In a series of studies in animal     models, the effects of exposing cones in the periphery of the retina to a large excess of     oxygen results in progressive oxidative damage to cone photoreceptors and cone cell death.     Compared to control patients, those with RP showed significant reduction in the reduced to     oxidized glutathione ratio (GSH/GSSG) in aqueous humor and a significant increase in protein     carbonyl content. This demonstration of oxidative stress and oxidative damage in the eyes of     patients with RP, suggests that oxidative damage-induced cone cell death in animal models of     RP may translate to humans with RP and support the hypotheses that (1) potent antioxidants     will promote cone survival and function in patients with RP and (2) aqueous GSH/GSSG ratio     and carbonyl content on proteins provide useful biomarkers of disease activity in this     patient population. Orally administered N-Acetylcysteine (NAC) has been found to be a     particularly effective antioxidant that promotes prolonged cone survival and maintenance of     cone function in a mouse model of RP. There is good rationale to test the effect of NAC in     patients with RP. The first step is to do test different dosing regimens to identify the     lowest dose that is able restore aqueous GSH/GSSG ratio and reduce carbonyl adducts on     aqueous proteins.      In patients with Idiopathic Pulmonary Fibrosis, polymorphisms within the TOLLIP gene were     found to influence outcomes of NAC-treated patients. The product of the TOLLIP gene,     toll-interacting protein, is an inhibitory adaptor protein downstream of toll-like receptors,     mediators of innate and adaptive immunity. The identification of the influence of TOLLIP     polymorphisms on the effect of NAC in Idiopathic Pulmonary Fibrosis provides rationale for     collecting DNA and genotyping the same single nucleotide polymorphisms (SNPs) in the current     trial. In addition to this candidate gene genetic analysis, patient RNA will be collected and     banked for future transcriptome analysis. The rationale for this is to identify gene     expression changes that modify disease progression in RP. There is substantial variability in     rate of progression among patients with RP. A patient who loses all vision early in life can     have a sibling with the same mutation who maintains vision into advanced age. This suggests     that modifier genes can have a major impact on cone survival. This study will test the     hypothesis that the level of expression of gene products that contribute to the antioxidant     defense system may influence cone cell death and hence the rate of loss of visual field. It     is also possible that gene expression differences may contribute to differences in response     to NAC. For these reasons collecting RNA samples from patients will allow next generation     sequencing in the future to understand the transcriptome background on which the study     intervention has been performed.   "
16999|NCT03063008|"     Clinical outcome with regard to oswestry disability index and lumbar fusion rate after     implantation of titanium coated PEEK cage and common PEEK cage   "
17000|NCT03062995|"     With the rising prevalence of allergic diseases and the subsequent risk of developing other     immune-related disorders, primary prevention of allergy has become a major priority. It is     generally acknowledged that breastfeeding is one of the main pillars in allergy prevention.     Infant formulas based on hydrolysed proteins have been developed to be used by infants at     increased risk of developing allergy in case a mother is unable or chooses not to breastfeed     her infant. The effect of hydrolysed formula in allergy prevention has been examined in many     studies, from which it can be concluded that currently there is not sufficient evidence to     support hydrolysed protein over intact protein for allergy risk reduction. Moreover, several     clinical trials support the suggestion of supplementation of pre and/or probiotics for the     reduction of eczema development, recognized by international authorities. The present study     (MAESTRO) investigates the preventive effect of a hypoallergenic concept combining several     nutritional approaches related to preventive strategies: partially hydrolysed protein formula     supplemented with prebiotics and probiotics. The aim of the present study is to investigate     the efficacy, growth and safety of this concept compared to standard (intact protein) infant     formula on the development of allergic manifestations up to the age of 12 months in infants     at increased risk of developing allergy.   "
17001|NCT03062982|"     This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The     participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of     Fluzoparib 120mg in fasted state in Period 2.   "
17002|NCT03062969|"     Shortly after the implementation of Comprehensive Chromosome Screening (CCS) techniques for     Preimplantation Genetic Screening (PGS) came the transition in biopsy timing. Trophectoderm     biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell     analysis.   "
17003|NCT03062956|"     Up to 56 healthy volunteers will be given a single dose of MYK-491 or placebo and be     monitored for safety and tolerability over a 7 day period.   "
17005|NCT03062930|"     Stroke survivors with severe contralesional paresis often have substantial control and     coordination deficits in the non-paretic arm. Because this arm must serve as the primary     controller, these deficits can be functionally devastating. The investigators now hypothesize     that the combination of severe paresis (Upper Extremity Fugl-Meyer Score ≤35) and persistent     motor deficits in the non-paretic arm limits functional independence in chronic stroke     survivors. The investigators predict that remediation, focused on the non-paretic arm should     improve functional independence. The investigators propose a randomized study design with two     tracts, two periods and four assessments. The investigators envision this study as the first     step in establishing the basis for a rehabilitation approach that focuses on remediation of     BOTH arms, which constitutes a substantial change from current remediation protocols focused     only on the contralesional arm.   "
17006|NCT03062917|"     This study will compare the novel methods of NS and BS with the standard technique of     nasophayngeal aspiration (NPA) and routine ETT suction. We shall assess the samples for     diagnosis of RSV, viral load and immune responses in the airways of babies with RSV     infection. We shall also assess the genetics of babies included in this study, to see if they     may be vulnerable to RSV infection.   "
17007|NCT03062904|"     There exists a physiological limitation of the expiratory flows because of the physical     properties of the bronchial tree (flexible bronchial walls in a complex architecture     subjected to variations of pressure and volume). For a given lung, in a given state, for each     pulmonary volume there is a corresponding Maximum Expiratory Flow (MEF). In healthy subject,     the bronchial smooth muscles have a basal tonicity which is not negligible. If the tonicity     is increased, this generally leads to a reduction in MEF. If it is decreased, MEF rather     tends to increase, there are healthy individuals for whom the inhibition of the contraction     of the bronchial smooth muscles by inhalation of bronchodilatator leads to a reduction in the     MEF: this is called paradoxical effect. When this reduction exists, it appears it occurs at     low pulmonary volumes (approximately 50% for a volume of less than 25% of the CV). Under this     circumstance, it seems that the basal tonicity of the bronchial smooth muscles would fight     against the expiratory collapse of the bronchi, and this would happen especially for distal     bronchi, for low pulmonary volume and for forceful expiration. The existence of such a     phenomenon would be in favour of a stiffening role of the bronchial smooth muscles. The     bronchial smooth muscles would not be only harmful cells causing of the asthma attacks.   "
17009|NCT03062878|"     The overall goal of this project is to determine the effects of anti-cancer chemotherapy on     reflex control of blood pressure and vascular function. Recent data have demonstrated that     cardiovascular disease-related mortality is the 2nd cause of morbidity and mortality for     7-year cancer survivors treated with chemotherapy. This anti-cancer treatment-mediated     cardiotoxicity is a progressive process that begins at the molecular level, progresses to     myocardial injury and left ventricular dysfunction, cumulating as heart failure and     cardiovascular disease-related mortality. In parallel to these cardiac-specific changes,     chemotherapy has also been shown to increase the risk for vascular-related abnormalities.     However, the impact of adjuvant treatments on the function and structure of the peripheral     vascular system remains poorly understood. With normal aging, two of the most important     vascular adaptations to arteries, which strongly contribute to the increased risk of     vascular-related and general cardiovascular disease, are an increase in large artery     stiffness and dysfunction of the vascular endothelium. Therefore, the overall goal of this     project is to determine the effects of anthracycline-based chemotherapy on large and small     artery function and structure. The central hypothesis is that this type of cancer therapy     results in negative vascular consequences as determined by non-invasive evaluation of     spontaneous blood pressure control, carotid artery stiffness, and vascular     endothelium-dependent vasodilation.      This observational study is designed to increase our understanding of the vascular changes     that occur during and following anti-cancer chemotherapy and provide insight into new methods     that will decrease cardiovascular disease risk in those treated for cancer.   "
17010|NCT03062865|"     Rheumatoid arthritis (RA) is a complex and multifactorial autoimmune disease. The biological     treatments that are currently available for the treatment of RA are the TNF-alpha inhibitors.     Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid     arthritis. The anti-TNFs were the first to enter the market, and they revolutionised the     prognoses of patients with RA. They remain the most common first-line biotherapy and are the     most used at this time.      The French Society of Rheumatologists intends to coordinate a prospective national registry     study for this follow-up.      This registry will include 1500 RA patients from the start of treatment with anti-TNF-α and     then followed for 5 years, regardless of the therapeutic modifications occurring thereafter.      This registry is an observational, multicentre, longitudinal, prospective registry study The     objectives of this registry is to contribute 1) to evaluate the therapeutic management of     patients; and 2) to improve this therapeutic management.   "
17011|NCT03062852|"     Serious medication administration errors are common in hospitals and nurse's interruptions     during medication preparation and administration is associated with errors. Various     interventions were developed to help prevention of errors such as visual intervention.     Investigators aimed to study the effect of a medication safety vest to reduce medication     errors. The vest serves as a visible signal to inform others that the nurse is preparing and     administering medications and should not be disturbed. Patients and visitors are provided     with an informational flyer to inform them about the use of medication safety vests.      The hypothesis is that the vest will reduce nurse's interruptions during medication     preparation and administration, and ultimately reduce medication errors.      The study is a randomized controlled trial in 30 care units of four hospitals in France. Each     unit will be randomized in either the control group or the experimental group using the     medication safety vest. Nurses of the unit will be selected at random to determine who will     be observed during the administration rounds.The observation method will be used to evaluate     the error rates in the 2 groups. The number of interruptions and error rates will be     evaluated.   "
18137|NCT03048123|"     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion     chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with     large and unresectable hepatocellular carcinoma staged BCLC A/B.   "
17013|NCT03062826|"     This protocol describes a perspective,multicenter study intended to test the hypothesis that     patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis     (diameter stenosis <70%) can be stabilized by effective antithrombotic treatment without     stent implantation, thereby avoiding both early and late complications related to     percutaneous coronary intervention (PCI).      Patients with STEMI within 12 hours will be included for screening. Thrombus aspiration will     be performed in patients with large thrombus burden and TIMI flow grade less than 2 to     restore blood flow. OCT will be used to assess the underlying mechanism including plaque     rupture, erosion, calcified nodule, and other uncommon reasons.   "
17036|NCT03062527|"     The purpose of the present study was to assess the influence of low vs moderate glycemic     index of a 3-week diet on aerobic capacity, endurance performance and body mass and     composition in endurance-trained athletes in a randomized, controlled crossover trial.   "
17037|NCT03062514|"     Children with refractory epilepsy who are candidates for a treatment with vagus nerve     stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters     are programmed and adjusted during outpatient clinic visits, within the normal clinical     practice.   "
17038|NCT03062501|"     This study will investigate the safety, tolerability and potential for the use of up to three     daily doses of 30-40 mg/kg HU (daily) upon hospitalization for painful vaso-occlusive crises     .   "
17014|NCT03062813|"     This study was to evaluate the efficacy and safety of Tacrolimus combined with entecavir     antiviral therapy for HBV-associated glomerulonephritis in china. Tacrolimus combined with     entecavir rapidly and effectively induced remission of HBV-GN in Chinese adults. Meanwhile,     Tacrolimus may have a synergistic antiviral effect with entecavir. The study protocol was     reviewed and approved by Guangdong General Hospital's Ethic Committee, and all participants     provided written informed consents. The study will be a prospective,     randomized,controlled,single-blind, multi-centre, withdrawal study conducted by Guangdong     general hospital, Guangdong Academy of Medical Sciences.there will be two phases, phase 1,     Screening and enrolling 112 HBV-GN patients about one year,and phase 2, ongoing follow-up for     24 weeks.The data of all patients will be recorded in the HBV-GN electronic database.Before     the randomisation, All patients will receive entecavir routine antiviral therapy for two     weeks.And then they will be randomized to two different group,the treatment group: Tacrolimus     combined with entecavir antiviral therapy,the control group: The Tacrolimus placebo and     entecavir antiviral therapy. The Tacrolimus target trough concentration was 5-10 ng/mL during     the therapy. The primary outcome variables were the number of patients who reached complete     or partial remission (CR or PR) after the 25 week-treatment. CR was deﬁned as <0.3 g/24 h     proteinuria (UPCR<300mg/g.cr) or lower plus stable renal function (eGFR>50 ml/min/1.73 m2)     and PR as proteinuria 0.3-3.0 g/24 h (UPCR 300-3000mg/g.cr) and 50% lower than baseline     proteinuria plus stable renal function. Secondary outcome variables: 1) The number of     patients who reached complete or partial remission (CR or PR) after the 13 week-treatment. 2)     Serum creatinine (SCr) increased 2 times the baseline levels or 50% lower than the baseline     eGFR(according to chronic kidney disease-EPI (CKD-EPI) )after the 25 week-treatment. 3)Serum     HBV DNA was undetectable(HBV DNA<500copies/ml) at the end of 25 week-treatment. 4) The number     of patients who present acute kidney injury at the end of 25 week-treatment.   "
17015|NCT03062800|"     The study for innovative strategies is warranted in the treatment of advanced non-squamous     NSCLC with epidermal growth factor receptor wild-type or unknown mutation status because the     outcomes remain unsatisfactory for most patients. Maintenance treatment after first-line     chemotherapy is a very interesting strategy that has been largely investigated in the last     years. This study is to evaluate the efficacy and toxicity of thalidomide in combination with     chemotherapy and as maintenance treatment in patients with advanced non-squamous NSCLC.   "
17016|NCT03062787|"     It is a post-license, multicenter, randomized, single blind, controlled study comparing a     single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).   "
17017|NCT03062774|"     This is an open label, multiple dose study, pharmacokinetic and pharmacodynamics studies will     be performed at the same time with tolerability study. Three dose arms are designed, 12     subjects will be enrolled in each arm, will equal number of males and females.   "
17019|NCT03062748|"     The purpose of the study is to compare the relative contribution of systemic inflammation vs.     Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting     cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep     apnea.   "
17020|NCT03062735|"     This study is a randomized controlled trial on the efficacy of inspiratory muscle training on     swimming performance, airway dysfunction and perceived breathlessness in elite swimmers.   "
17021|NCT03062722|"     Prospective controlled clinical trial in which a minimally invasive microsurgical approach     was used following the keyhole principle in 55 patients and 65 hands under local anesthesia     and ambulatory strategy. All patients included in the study had an average of 3 months     disease course and were considered refractory to conservative treatment. Patients were     evaluated with stringent inclusion criteria with the Levine severity and functional status     scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are     reported.   "
17022|NCT03062709|"     This study aims to assess the feasibility of using an intervention for environmental smoke     exposure in children that uses cotinine testing results with written materials and telephone     counseling for a potential future study of parents whose children are admitted with     respiratory illnesses to The Barbara Bush Children's Hospital in Portland, Maine.   "
17023|NCT03062696|"     The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10     individuals ages 10 and older who have rumination disorder   "
17024|NCT03062683|"     The investigators compared the serum lactate, serum prolactin and serum creatine kinase     concentrations following convulsive and non-convulsive syncopes. The aim of the study was to     investigate their importance as diagnostic markers in transient loss of consciousness.   "
17025|NCT03062670|"     Through this research we intend to evaluate whether a team-based care delivery approach using     daily huddles is effective in improving caregiver and patient outcomes in primary care     setting. This approach is expected to not only lead to effective primary care delivery     outcomes, but also result in greater team morale, reduced burnout, and a higher rate of     innovation.   "
17028|NCT03062631|"     Congenital myasthenia and LEMS are potentially lethal disorder, which, even with careful     management, significantly impedes participation in normal daily functions. Currently approved     therapies have had little impact on promoting a normal quality of life activity in these     patients. The goal is to systematically examine the effect of 3,4-DAP on the natural course     of this disease and to gain additional experience in titrating 3,4-DAP with other available     therapies to maximize clinical function and development in this patient population.      The specific aim of this study is to evaluate the use of 3,4 Diaminopyridine (DAP) on     selected patients proven by genetic or serum antibody testing to have Congenital Myasthenic     Syndrome (CMS) or Lambert-Eaton Myasthenic Syndrome (LEMS). We will evaluate the patient for     CMS or LEMS, prescribe 3,4 DAP, and then clinically evaluate the response.   "
17029|NCT03062618|"     This study consists of three parts: single oral dose escalation in healthy volunteers (Part     A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants     with chronic plaque psoriasis (Part C)   "
17039|NCT03062488|"     The purpose of this study is to compare the incidence of EA in pediatric patients undergoing     minor ENT surgery under Sevoflurane and compare opioid-only based intra-operative analgesia     to multi-modal analgesia consisting of opioid and IV acetaminophen or PO acetaminophen     regimen using a validated and standardized EA measurement tool, the Pediatric Anesthesia     Emergence Delirium (PAED) scale. The post operative pain scores will be measured in all     patients by post-op recovery staff using FLACC Score/Wong-Baker FACES (patients 24 months up     to 7 years of age) or Numeric Pain Score for patients 7 years of age. The pre-operative,     surgery, anesthesia and post-operative staff will be all blinded.   "
17049|NCT03062358|"     The purpose of this study to determine the efficacy and safety of pembrolizumab or placebo     given with best supportive care (BSC) in Asian participants with previously systemically     treated advanced hepatocellular carcinoma (HCC). The primary hypothesis of this study is that     overall survival is prolonged in participants who receive pembrolizumab compared to those who     receive placebo.   "
17030|NCT03062605|"     The purpose of the study is to determine the effect of a two-step mouth rinsing procedure on     reducing the germs (mutans Streptococci) that cause tooth decay. We hope that the two-step     mouth rinse (0.3% NaOCl followed by 10% Povidone Iodine) decreases the tooth causing germs     better than the one-step mouth rinse (10% Povidone Iodine). The mouth rinse for both     treatment groups is done only once at the beginning of the study after the initial saliva     samples are taken, and before a detailed examination of the teeth and gums. It is     hypothesized that the treatment group receiving the NaOCl and Povidone iodine will have     significantly lower microbial counts than the control group (Povidone iodine) because the     NaOCl will disrupt the microbial biofilm and make the Povidone iodine more effective in     decreasing the microbes in the biofilm. Microbial counts are made from Salivary samples taken     from participants at baseline, one week, one month, two months and three months. The samples     are tested by two commercial methods for determining microbial counts. The CariScreen Test is     a rapid bioluminescence assay that quantitates the total number of all of the organisms     present. The CRT test requires a culture media that is specific for the two germs (S. mutans     and Lactobacillus) strongly associated with tooth decay. The results of the CRT Test are read     after three days of incubation.   "
17031|NCT03062592|"     Several free fatty acids receptors (FFARs) have been discovered. These have been implicated     in metabolic processes and inflammation. Consequently, these receptors have attracted     interest as targets for the treatment of metabolic and inflammatory diseases, including     obesity and T2D. Two of these FFARs (FFAR1, FFAR4), which is activated by specific free fatty     acids (FFAs), is expressed on enteroendocrine cells, pancreatic beta-cells and adipocytes.     They have been linked to 1) increased GLP-1 secretion and hence the incretin-mediated     increase in glucose-stimulated insulin secretion (GSIS) and suppression of glucagon     secretion, 2) a direct positive effect on GSIS, 3) reduced inflammation and 4) improved     insulin sensitivity. These functions and the abundance of fatty acids in food suggests that     FFARs can be considered as nutrient sensing regulators of metabolism. Roux-en-Y gastric     bypass (RYGB), frequently results in immediate beneficial effects on glucose metabolism and     often complete remission of T2D. This may in part be explained by increased GLP-1 levels     after surgery. It appears that the effect depends on nutrient delivery directly to the lower     parts of the small intestine. It is possible that the RYGB effects are partly due to     enteroendocrine stimulation of FFAR1 and perhaps FFAR4 by direct nutrient delivery, i.e. FFA     release in the lower intestines. Pinolenic acid from pine nuts has been shown to be a potent     dual FFAR1/FFAR4 agonist.      Based on these findings we have planned a number of human intervention studies in order to     investigate 1) the optimal oral formulation of pine nut oil 2) whether we can mimic the     beneficial effects observed after RYGB, 2) if we can increase meal-related GLP-1 secretion by     stimulating FFAR1/FFAR4 on enteroendocrine cells causing improved GSIS and increased satiety     and 3) enhancement of GSIS by directly stimulating FFAR1 (and perhaps FFAR4) on beta-cells.   "
17032|NCT03062579|"     Neuromyelitis Optica Spectrum Disorder (NMOSD) is a severe inflammatory disease of the     central nervous system characterized by relapsing optic neuritis and longitudinal extensive     transverse myelitis. The specific autoantibody against aquaporin 4 (AQP4-ab) has been     suggested to contribute to the pathogenesis of the disease. Peripheral blood plasma cells are     a major source of AQP4-ab. Previous studies have observed increased IL-6 levels in serum and     cerebrospinal fluid of patients with NMOSD, particularly during relapses. Exogenous     interleukin (IL)-6 promotes the survival of plasma cells and their production of AQP4-ab in     vitro. And blockade of IL-6 receptor signaling by an anti-IL-6 receptor antibody reduces the     survival of plasma cells in vitro. Tocilizumab (ACTEMRA®), a humanized monoclonal antibody     against the IL-6 receptor, has shown beneficial clinical effects in some patients with NMOSD     when concomitant immunosuppressive medications were administered. However, the long-lasting     biological effects of preceding immunotherapies such as rituximab might overlap with the     subsequent tocilizumab therapy. To reduce the side effects of concomitant treatments to large     extent and verify the beneficial effects of tocilizumab, we evaluate the safety and efficacy     of tocilizumab as monotherapy in patients with NMOSD.   "
17033|NCT03062566|"     The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated     in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in     patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as     predictors of neurological outcome and mortality may underline the potential of a     point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate     monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the     clinical decision-making regarding treatment and level of care offered to the patient.      Hypotheses:        1. Prehospital S100B level is a significant predictor of unfavourable neurological outcome          (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E)          measures) in severe TBI patients.        2. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome          (dichotomized DRS and GOSE measures) in severe TBI patients.        3. Prehospital NSE level is a significant predictor of unfavourable neurological outcome          (dichotomized DRS and GOSE measures) in severe TBI patients.        4. combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of          unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI          patients.        5. Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI          patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.   "
17058|NCT03062241|"     The aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in     patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy     (endurance) of the procedure itself. The study hypothesis is that cryoablation in eligible     patients with CHF and ICD/CRT (implantable cardioverter defibrillator / cardiac     resynchronization therapy) implants reduce the number of recurrent CHF hospitalizations,     mortality, need for mechanical support of LV (left ventricle) and heart transplant (primary     endpoint) at 1 year observation in comparison to traditional (pharmacological) treatment..   "
17034|NCT03062553|"     The proposed study aims to use a form of neuromodulation, known as transcranial alternating     current stimulation (tACS), to improve the effectiveness of the metacognitive training (MCT)     program for treatment of delusions in schizophrenia. tACS is a non-invasive brain stimulation     method utilizing weak electrical currents applied to the head to influence neural firing     (Antal & Paulus, 2013). Brain regions implicated in delusional thinking will be targeted in     the hopes of promoting thinking patterns that will allow participants to question delusional     beliefs, reducing the severity of delusions and increasing the positive effects of MCT     (Whitman et al., in press; Whitman, Minz & Woodward, 2013). Electroencephalogram (EEG) and     behavioural assessments will be used to measure treatment effects.   "
17265|NCT03059537|"     This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively     compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250     mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species     including 7-alpha-CHO and serial blood samples after the stimulation.   "
17040|NCT03062475|"     Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated     with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly,     with the gradual opening of a two-child policy, more and more Chinese women of reproductive     age enter pregnancy have a history of GDM. Our previous study showed that regular exercise     commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese     overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of     lifestyle intervention with detailed information on how to eat and how to diet in preventing     the recurrence of GDM.   "
17041|NCT03062462|"     With the widespread use of clopidogrel, resistance to clopidogrel has been attracting     increasing attention, and emerged as a new challenge adversely affecting patients clinical     risk and outcome. Clopidogrel resistance means that blood platelets show little or no     response to clopidogrel. It is closely associated with increased risk of serious     cardiovascular events, seriously affects the prognosis of patients, and brings difficulties     to clinical treatment.      Guideline recommendations on the use of dual antiplatelet therapy have been formulated that     ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus     aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could     significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular     events. The previous studies have reported that half-dose ticagrelor had the similar     inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was     significantly stronger than that in the clopidogrel group. But it is still not very clear     that the effect of low-dose ticagrelor on platelet function in patients with clopidogrel     resistance and coronary heart disease.      Therefore, we performed this randomized, single-blind clinical trial to observe the effects     of low-dose ticagrelor and double standard-dose clopidogrel on platelet aggregation and     prognosis in clopidogrel resistance's patients with coronary heart disease.   "
17042|NCT03062449|"     This is a Phase IIa, randomized, double-blind, placebo controlled trial. Subjects for     participation in this study will be identified by the Investigator based on their Clinical     Dementia Rating score which will be completed as part of standard practice. Patients meeting     the criteria for early Alzheimer's disease will be considered for study participation, with     the Investigator taking the additional inclusion/exclusion criteria into consideration. Up to     40 subjects will be enrolled. Subjects participating in the study will be randomized to     receive either gummies containing L-Serine or placebo gummies, with the Investigator and     study staff blinded to the group assignments.   "
17043|NCT03062436|"     Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with     tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep     molecular response which has been sustained for at least three years, can be taken off the     drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In     case there is evidence of disease recurrence on highly sensitive molecular assays, their drug     therapy is restarted. The study aims to identify proportion of patients who can be kept off     drug therapy in a state of sustained molecular remission.   "
17044|NCT03062423|"     Comparative randomized, single dose, three way three sequence two treatment partial replicate     crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier     400 mg F.C.T (Al-debeiky pharma, Egypt) versus Sovaldi 400 mg Tablets (Gilead Sciences,     Canada)   "
17105|NCT03061630|"     Previously-untreated, high-risk (>T3 and/or N+) muscle-invasive bladder cancer (MIBC)     cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1   "
17106|NCT03061617|"     It is controversial as to which ventilation mode is better in one-lung ventilation(OLV),     volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was     designed to figure out if there was any difference between these two modes on oxygenation and     postoperative complications under the condition of protective ventilation(PV).   "
17045|NCT03062410|"     Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide     to evaluate treatment efficiency. In contrast Health Related Quality of Life (HRQOL)     assessment is often restricted to clinical trial. It could be of particular interest to     evaluate HRQOL in daily clinical practice in order to adequately choose and manage first line     therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall     survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in     daily clinical practice of the HRQoL data using standardized questionnaires could strengthen     management of symptoms : improve symptom control, improve patient-clinician communication,     satisfaction with care and well-being of the patient and in fine the overall survival.      The objective of the QUANARIE Study is to assess the feasibility of HRQOL assessment in daily     clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using     electronic patient reported outcome (PRO).      Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to     clinicians, to help medical professionals to optimize their practices by adopting a holistic     and personalized approach based on patient reported outcomet.   "
17046|NCT03062397|"     Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic     Stroke   "
17047|NCT03062384|"     The purpose of this study is to evaluate if the use of a yeast-selenium supplement (AT-001)     is safe in elderly subjects who do not have dementia, and further, to see if the supplement     improves tests that are related to brain health.   "
17048|NCT03062371|"     Play encourages the development of a child's social and cognitive skills. Playgroups are     interactive environments that facilitate these developmental abilities and provide     opportunities for parents to engage with their children. A lack of play can have negative     effects on a child's development and may result in a decline in social participation.      Objective: The purpose of this research is to investigate if children between the ages of 15     months and 5 years old demonstrate improved levels of playfulness, social- emotional growth,     and participation through playgroup intervention, provided in various settings in the     community. Investigators will also examine the impact that these playgroups have on     participating caregiver's confidence levels in regards to their abilities in taking their     child/children on outings in the community.      Method: A quasi-experimental stepped-wedge design with one way cross-over will be used. This     study will look at the effectiveness of all playgroups, and then determine differences in the     three groups: 25 pairs will be in a control standard of care early intervention playgroup, 25     pairs will take part in a occupational therapy led playgroup,and 25 pairs will be     participating in a standard of care early intervention playgroup with additional occupational     therapy support. The control site will be the same site as the support playgroup (cross-over,     wait-list). The Test of Playfulness will measure child playfulness, the Social Profile and     Assessment of Preschool Children's Participation play sub scale will determine child     participation, the Devereux Early Childhood Assessment will determine social emotional     growth, and the Parenting Sense of Competence Scale will determine the caregiver sense of     competence. Mean differences will be analyzed using a mixed analysis of variance to determine     significant changes over time for each group. We hypothesize that playgroups will have a     significant effect on child playfulness, social-emotional growth, participation, and parent     competence.   "
17050|NCT03062345|"     Virtual reality is a video game in which a person and their real-time movements are     represented on a screen in a virtual environment. This study will compare the use of     multi-user virtual reality (VR) to single-user VR to determine if either provides superior     engagement in upper extremity therapy and greater motivation to perform repetitive training.      Stroke survivors will participate in a longitudinal study in which they will have the     opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in     their homes. They will use each mode for 2 weeks, completing 4 session per week, each session     is 1 hour long. Upper extremity motor control, level of engagement, and active range of     motion will be assessed at time points during the intervention period.      Subject evaluations will take place before the intervention, at the midpoint of intervention     (between switching from multi-user to single-user modes, or vice versa), and at the end of     the intervention.      The investigators hope to address two aims:      Aim 1: To determine if the use in-home multi-user virtual reality treatment results in     greater engagement in therapy compared with in-home single user virtual reality treatment.      Aim 2: To determine if in-home virtual reality treatment results in greater practice      The investigators hypothesize that stroke survivors will be more engaged in therapy when     training with the multi-user VR system and this will translate into greater practice.   "
17051|NCT03062332|"     Background: The gut microbiome is emerging as an important factor in regulating mental health     yet it remains unclear what the target should be for psychiatric treatment. Investigators aim     at elucidating the complement of the gut microbiome community for individuals with Major     Depressive disorder (MDD) and Bipolar disorder (BD) relative to controls, and test for     relationships with symptoms.      Methods: Investigators prospect to recruit subjects including patients and controls amount to     240. All subjects will be collected for blood and stool samples,assessed by clinical scales.     Finally, analyzing the correlation among the metabolon in blood, microbiota in stool and     clinical scales to obtain the possible interaction between diseases and gut microbiota.   "
17052|NCT03062319|"     The Purpose of this open-label randomized controlled multicenter trial is to evaluate the     efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination     therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial     fibrillation and atherothrombosis.   "
17053|NCT03062306|"     In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to     show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions     have critical importance for neurological results and life quality after the return of     spontaneous circulation (ROSC).   "
17054|NCT03062293|"     The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per     week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low     back pain in adults ages 18-60.   "
17055|NCT03062280|"     Subjects completing study DIUR-005 and those who have already completed study DIUR-003 will     be offered the opportunity either to continue Chronocort® therapy or to switch from their     current glucocorticoid therapy to Chronocort® in this open-label study.   "
17056|NCT03062267|"     Testing an mHealth mobile interventionist texting program on illness management.   "
17057|NCT03062254|"     Broadly, the objective of this study is to evaluate the fractional decline of intensity of     tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer     following treatment with radium-223 as a surrogate marker for tumor cell killing.   "
17059|NCT03062228|"     This study was designed and conducted in an effort to establish a comparison group for the     Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth     weight, of a belt-like device to help pregnant women to avoid sleeping on their back during     sleep in the third trimester. This study will seek to establish the typical birth weight of     babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics     to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep     during pregnancy nor have received a device to prevent back sleep.   "
17060|NCT03062215|"     The study seeks to evaluate the efficacy of a culturally adapted internet-delivered treatment     for depression in Colombia. The research involves two studies: (a) the cultural adaptation of     the Space from Depression cognitive-behavioural internet-delivered programme, and (b) the     implementation of the culturally adapted intervention using a randomised controlled trial     methodology. The study will be a first contribution of a culturally adapted low-intensity     internet-delivered intervention with Latin Americans.   "
17061|NCT03062202|"     This study will explore the potential impacts of internet-delivered cognitive behavioural     therapy (ICBT) at step 3 of the IAPT model. To do this, interventions administered as a     prequel to face-to-face therapy will be analysed and compared based on their impacts in     regards to access, outcomes (psychological) and costs. A qualitative segment will also be     conducted in order to investigate the acceptability and usability of the platform for     clinicians and the possibility of developing a therapeutic alliance through an online medium.   "
17062|NCT03062189|"     The purpose of this study was to assess drinking habits and patterns of alcohol consumption,     smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use     disorders among Italian young students. Furthermore to investigate the correlation between     binge drinking and alcohol use disorders.   "
17063|NCT03062176|"     The Interleukin-1 Blockade for the Treatment of Heart Failure in Patients with End-stage     Renal Disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a     Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human     Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with     end-stage renal disease and heart failure.   "
17064|NCT03062163|"     To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in     overweight volunteers   "
17087|NCT03061864|"     Pregnant women who are at risk of delivering their infants in the periviable period can     suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over     their own pregnancy. There is some evidence that more counseling and planning can help reduce     maternal stress and anxiety. Patients at risk of delivering in the periviable period will be     randomized to either receive standard counselling or to complete the periviable birth plan.   "
17088|NCT03061851|"     The patients with type 2 diabetes who underwent routine hypoglycemic agents and insulin     therapy were evaluated for 48 weeks with maltose software.   "
17065|NCT03062150|"     The steroid hormone cortisol is released in response to stress and acts in the central     nervous system upon glucocorticoid (GR) and mineralocorticoid receptors (MR). GR are widely     distributed across the brain while MR are predominantly expressed in the hippocampus and     prefrontal cortex - two brain areas closely related to memory and executive function.     Stimulation of MR leads to an increase of glutamate that act on glutamatergic NMDA receptors     in the hippocampus and prefrontal cortex. In previous studies, the investigators have shown     that fludrocortisone, a mineralocorticoid receptor (MR) agonist, improves memory and     executive function in depressed patients and healthy controls. However, depressed patients     not only exhibit cognitive deficits in traditional neuropsychological domains such as memory     or executive function. In addition, there are depression-specific alterations such as     cognitive bias and deficits in social cognition, two clinically highly relevant areas.     Therefore, the specific aims of this renewal proposal are two-fold:        -  To examine whether beneficial effects of fludrocortisone in depressed patients can be          extended to depression-specific cognitive bias and to social cognition        -  To determine whether beneficial effects of fludrocortisone depend on NMDA-receptor          function and whether these beneficial effects can be enhanced by NMDA receptor          stimulation.      The investigators hypothesize that fludrocortisone will improve cognitive bias and social     cognition in depressed patients and that its beneficial effects depend on the NMDA receptor.     Therefore, the investigators further hypothesize that the effects of fludrocortisone can be     enhanced by co-administration of the partial NMDA receptor agonist D-cycloserine.      The study not only advances current knowledge by further examining the mechanism of action by     which MR stimulation exerts beneficial effects on cognition but extends these effects to     depression-specific cognitive bias and alterations in social cognition. Furthermore, a     potential interaction between MR and NMDA receptors is highly clinically relevant given the     promising results with NMDA receptor antagonists in the treatment of major depression.   "
17066|NCT03062137|"     An observational comparison of different locations of saturation measurements during Flexible     Bronchoscopy   "
17067|NCT03062124|"     Intraductal papillary mucinous neoplasms (IPMN) have a potential to develop into a malignant     disease with varying severity. Decision making on when and how to make a therapeutic     intervention is not simple. Endoscopic equipment that can enter the pancreatic duct itself     can provide the much needed additional information on the cystic condition. Visual     inspection, direct visual guided biopsies from the target and the cytology of the flushing     fluid of the pancreatic duct may be helpful in the decision making process of when and how to     treat the condition. We study whether SpyGlass pancreatoscopy brings accuracy to the     diagnostic process concerning IPMNs and does it provide additional information to help make     decisions about therapeutical interventions. We also document complications related to the     procedure itself in the following weeks after the procedure.   "
17068|NCT03062111|"     Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and     epithelial cells of the prostate gland. The enlarged gland has the potential to result in     lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or     increased muscle tone and resistance, or both.      For decades transurethral resection of the prostate (TURP) has been the gold standard for     treatment of symptomatic BPH that is refractory to nonoperative management. This is a     surgical intervention aimed to reduce the size of the prostate gland. However, over the past     fifteen years, many alternative therapies have been introduced including laser enucleation of     the prostate (LEP). LEP has numerous advantages including decreased blood loss and length of     hospital stay as well as increased effectiveness and safety for large prostate gland sizes     (>80g).   "
17069|NCT03062098|"     This trial seeks to improve ultrasound imaging during embryo transfer in IVF by using a     small, high resolution ultrasound probe used routinely for cardiac imaging in children.   "
17070|NCT03062085|"     The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery     using a large-scale and comprehensive database of high myopic cataract and age-related     cataract patients. The investigators will further investigate into the various genetic and     environmental factors that may contribute to the pathogenesis of high myopic cataract.   "
17071|NCT03062072|"     To assess chemotherapy related hyperglycemia in non-diabetic patients, the investigators will     assess the incidence of hyperglycemia and analyze co-medications and risk factors.   "
17072|NCT03062059|"     The aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine     instillation during operation to prevent intravesical recurrence after radical     nephroureterectomy in upper urinary tract urothelial carcinoma.   "
17170|NCT03060785|"     This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC)     pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the     participants will be transgender women on feminizing hormones, the other half will be male     volunteers not taking any hormone therapy.   "
17073|NCT03062046|"     The purpose of this study is to assess the safety, acute and long term effectiveness, during     standard RF ablation procedures while using Ablation Index and VISITAG™ software in     combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter.     Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation     lines is assessed. The study is a prospective, non-randomized, post-market clinical     evaluation. Up to 330 patients will be included in this study. All patients who qualify based     on the study specific requirements will be invited to participate. The total duration of the     study is estimated to be about 24 months (12 months enrollment period and 12 months of follow     up). The clinical investigation population include subjects undergoing RF ablation for     treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical     investigation, all subjects must meet the inclusion/exclusion criteria and are suitable     candidates for enrollment in a clinical investigation in the opinion of the investigator.     Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including     β-blocker) as evidenced by recurrent or are intolerant of the AAD.   "
17074|NCT03062033|"     Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in     outpatient psychiatry practices in the United States (US), as well as to describe the     associated disease burden in a cohort of patients with one or more psychiatric disorders and     a cumulative lifetime exposure to antipsychotic medication of three months or more.   "
17085|NCT03061890|"     The DINE study will test the hypothesis that potentially avoidable NICU-based exposures     contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates.     This hypothesis is drawn from the documented impact of phthalate exposure on early     development in term-born children, and the acknowledged presence of these toxic chemicals in     the NICU. Third trimester in utero exposure to phthalates have been linked to poorer     childhood performance in cognition, motor function, attention, hyperactivity and social     behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The     multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on     high-prevalence clinical outcomes.   "
17086|NCT03061877|"     Anxiety and depression are highly prevalent in people with rheumatoid arthritis (RA).This     study is to investigate the effect of anxiety and depression on treatment response in people     with RA using observational longitudinal study design.   "
17075|NCT03062020|"     The QUIPP tool integrates information of obstetrical history, quantitative fetal fibronectin     (qfFN) and cervical length to predict the risk of sPTB in asymptomatic high-risk women.      The aim of this study is to evaluate the QUIPP tool in our setting in order to optimize the     management of women at high risk for sPTB and to validate in a randomized clinical trial,     whether the use of QUIPP improves efficiently the management of our asymptomatic high-risk     women when it is compared with the current clinical management.      Design: Randomized controlled trial. Inclusion criteria: Asymptomatic singleton pregnancies     18,0-22,6 weeks at high-risk for sPTB. Sample size: According to a non-inferiority analysis,     129 pregnant women will be needed for each arm.      Methodology: Patient selection and who consent to participate in the study will be randomized     into two arms: a) Intervention group: QUIPP tool will be used to select and manage patients     attending our PBPC: high-risk patients will be followed-up in our PBPC and low-risk patients     will be discharged from PBPC and managed in a low-risk unit. b) Control group: Women will be     managed according to current clinical practice.      Main Outcome: sPTB <34,0 and <37,0 weeks of gestation. Secondary Outcomes: Pregnancy outcomes     and a neonatal composite morbidity. Expected Results: Perinatal outcomes are similar in the     intervention and control group although the intervention group using the QUIPP tool required     less medical resources.   "
17076|NCT03062007|"     This study will evaluate the safety and tolerability of BI-CON-02 in patients with     HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical     trial protocol for BI-CON-02 prescribes a start dose of 0,3 mg/kg. After the Data and Safety     Monitoring Committee evaluates the data of tolerability and safety of BI-CON-02, received     during 3 weeks of investigational product therapy (Week 3, Day 1) and approves, extra doses     can be used.      Once the safety of investigational product is confirmed, the dose will be increased in the     subsequent cohorts. Planned doses - 0,3 mg/kg; 0,6 mg/kg; 1,2 mg/kg; 2,4 mg/kg; 3,6 mg/kg and     4,8 mg/kg.   "
17077|NCT03061994|"     This study aims to 1)characterize the differentially expressed metabolites between     cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated     with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up     of a cohort and 3)to determine whether differentially expressed may affect the pathological     process of cardiomyopathies . Standardized protocols will be used for the assessment of     medical history and examinations, laboratory biomarkers, and the collection of blood plasma.   "
17078|NCT03061981|"     This is a randomized, double blind, placebo controlled, single ascending dose study to assess     the safety, tolerability, PK, PD and IE with metformin following a single oral dose of     DA-1241 in healthy male subjects.   "
17079|NCT03061968|"     The purpose of this study is to investigate the effects of acupressure application in very     low birth weight premature.   "
17080|NCT03061955|"     The objective of this study is to evaluate the safety and efficacy of concurrent     administration of influenza vaccine in patients receiving anti-PD1 immunotherapy (nivolumab     or pembrolizumab). This will be a prospective observational study, aiming to assess patient     tolerance of treatment, adverse events (incidence, grade, need for hospitalization),     incidence of influenza infections, and seroconversion rates.   "
17081|NCT03061942|"     The purpose of this study is to assess the effect of synovectomy on clinical outcomes of     arthroscopic rotator cuff repair.   "
17082|NCT03061929|"     Nutritional profile of mother's milk is influenced by various factors including     environmental, dietary and nutritional status of the mother. Given the huge diversity noted     in nutritional status and ethnic dietary patterns in Indian population, including pregnant     and lactating mothers, it can be conceivably predicted to have an influence on milk     composition. With the lack of recent literature addressing these, it is vital to understand     and update the influence if any, of nutritional status and dietary patterns on nutritional     quality of human milk. The proposed Human milk analysis clinical study in Indian mothers is     aimed to achieve a more recent and updated database of nutritional profile of Indian mother's     milk considering the dietary and regional influences and demographic differences which can     play a key role in levels of nutrients in mother's milk. In order to incorporate the varied     dietary patterns, milk samples will be collected from mothers recruited from 8 sites across     the country and analysed for important nutrient levels.   "
17083|NCT03061916|"     Chlorhexidine is the most potent chemotherapeutic agent against mutans streptococci and     dental caries, however, the incidence of side effects such as teeth discoloration, staining     of restorations, undesirable taste, discoloration of tongue, dryness and burning sensation in     the mouth discourage patients to use this mouth wash. Natural products are now preferred by a     large proportion of the population and have been reported to possess antimicrobial     activity.These products have recently been shown to be a good alternative to synthetic     chemical substances for caries prevention like Cinnamon and Ginger. The aim of this study is     to compare the antimicrobial effects of aqueous extracts of cinnamon 20% and ginger 20% in     comparison to chlorhexidine gluconate 0.2% on oral streptococcus mutans   "
17084|NCT03061903|"     High risk patients who receive direct anterior approach total hip arthroplasty are more     likely to experience wound complications. The purpose of this study is to determine whether     the usage of closed incision negative pressure dressings decreases the risk of wound     complication compared to standard dressings. Patients who decide to participate in the study     will be randomized to one of the two dressing prior to surgery and will leave the operating     room with one of the treating dressings. Patient will be monitored 90 days after surgery for     wound complications and pictures of the wounds will be taken. The patients course of     treatment besides being randomized to one of the two dressings will be identical to any other     patient received a Direct Anterior Approach for Total Hip Arthroplasty (DAA THA).      Primary outcome measure will be uneventful wound healing (requiring no intervention) versus     the occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence,     superficial or deep infection) requiring additional intervention. Intervention will be     defined as any attempt of the surgeon to improve wound healing (in-office debridement,     topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound).     Secondary outcome measures will include duration of wound healing delay, length of hospital     stay, number of days of antibiotic therapy, and direct and estimated indirect costs.     Statistical analysis will be performed to detect differences in the treatment groups.   "
17089|NCT03061838|"     This is a multicenter, double-blind, randomized clinical study of safety, tolerability,     pharmacokinetics and pharmacodynamics of biosimilar drug Ritumax® compared to original drug     MabThera® in patients with rheumatoid arthritis, receiving stable doses of Methotrexate.      At Week -2, after signing the Patient Information Sheet and Informed Consent Form, patients     with rheumatoid arthritis receiving stable doses of Methotrexate (10-25 mg per week orally or     parenterally) will pass screening procedures.      Patients meeting all the inclusion/exclusion criteria will be invited to the investigational     site for Visit 2 (Week 0) to be randomized into one of two treatment arms:        -  Ritumax® 1000 mg х 2 intravenous infusions        -  MabThera® 1000 mg х 2 intravenous infusions After being assigned to the treatment arm          patients will receive a course of study treatment, including two i/v infusions at 14-day          interval: at Week 0 and Week 2.      After that, patients will be followed up for the next 22 weeks. Safety, pharmacokinetic and     pharmacodynamic parameters will be monitored at this visits.   "
17090|NCT03061825|"     The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™     Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.   "
17091|NCT03061812|"     The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the assess the     efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants     with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like     protein 3 (DLL3) and who have first disease progression during or following front-line     platinum-based chemotherapy.   "
17092|NCT03061799|"     In women, as the age increases, ovarian function is lost, resulting in the deficiency of     female hormones, resulting in menopause, in which menstruation is permanently lost. The     average age of menopause in Korean women is 49.7 years old, which is equivalent to 22.3% of     the total female population. In addition, the increase in the number of women who experience     early menopause due to environmental factors such as stress as a result of the increase in     the number of women entering the society is also a major cause of the expansion of the market     for menopausal women's health functional foods. Women's menopausal symptoms have been     regarded as a natural process for everyone, but with the recent interest in health and the     results of related studies, the perception that menopausal symptom management is necessary     has spread.      In traditional medicine of far east asia, danggui (Angelica gigas Nakai), taeunggung (Cnidium     Rhizome), and broilers (Cinnamon bark) have been commonly used for postmenopausal symptoms     improvement. However, scientific evidence for these foods are lacking. Therefore, in this     study the investigators tried to examine the efficacy and safety of extracts of angelica     gigas nakai, cnidium rhizome, and cinnamon bark in postmenopausal symptoms. This study is     designed as double-blinded placebo control study.   "
17093|NCT03061786|"     Acute kidney injury (AKI) is a common clinical syndrome, especially in the hospital patients.     AKI is recognized as an important risk factor for incident chronic kidney disease,     accelerated progression to end-stage renal disease,and increased risk of short-term and     long-term mortality.This study is to observe the prognosis of hospitalized patients with AKI     in China.   "
17246|NCT03059784|"     High rates of recurrent cardiovascular events and readmission after percutaneous coronary     intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary     prevention. But many patients are lack of effective management after PCI.This study is aimed     to examine the effect of mobile application (APP)-based multifaceted management on the     improvement of long-term care after PCI.   "
19826|NCT03026049|"     Patients will be randomised between deep venous stenting or conservative management   "
17094|NCT03061773|"     The treatment of breast cancer at any given time can be through surgery, as well as adjuvant     treatments (radiotherapy, chemotherapy and hormone therapy) alone or together. And with this     the patient tends to lose weight, he becomes depressed, resulting in an increasingly     debilitating picture. Therefore, the present study aims to investigate the relationship     between physical exercise and its effects on quality of life in patients with breast cancer,     those who underwent surgery for at least 6 months, patients who are still with the Tumor     using the adjuvant treatments submitted to physical exercises and not submitted. The sample     will consist of 25 to 50 female patients aged 18 to 75 years. Patients will be submitted to     the initial quality of life evaluation (SF - 36 reduced version, Anxiety and depression (HAD     Scale), Fatigue (Piper Fatigue Scale), Pain (Brief Inventory of Pain), Body Composition     (Bioimpedance BYODINAMICS 450 ) And oxidative stress markers (oxidized and reduced     glutathione, TBARS / MDA, Myeloperoxidase and Creatinine), inflammatory markers (IL1, IL6,     IL8, IL10, MCP-1 and TNF-α), hormones Estrogen, progesterone), blood test (complete blood     count) 24 hour food recall (24hs food recall), and perform the maximum repetition test to     find the initial workload that will be adjusted every 4 weeks with the evaluation of the load     and Completing the 12 weeks of training will be reevaluated following the initial evaluation.     The data collected will be treated statistically with an α=5% using the software Stata 12.0.   "
17095|NCT03061760|"     This study is designed to evaluate men before radical prostatectomy for the incidence of     Overactive Bladder (OAB), as well as urge urine incontinence (UUI) development after the     surgery. Patients will be evaluated for signs of OAB and for signs of Bladder Outlet     Obstruction (BOO). Afterwards they will be divided into four observational groups. Follow up     period is designed to be 12 months.   "
17096|NCT03061747|"     Multicentric, observational, retrospective registry including patients underwent implantable     device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016,     followed by remote monitoring. The aims of the registry are to evaluate the occurrence of     atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.   "
17126|NCT03061357|"     This project was to examine the effects of incorporating modern wearable technology into the     credit-based Physical Activity Instructional Program for promoting habitual levels of     physical activity among college students.   "
17127|NCT03061344|"     Study Objectives The current definitive treatment options for urethral stricture disease     include endoscopic urethrotomy known as Direct Vision Internal Urethrotomy (DVIU) or open     reconstruction known as urethroplasty (1-6). The purpose of this study is to determine     feasibility of endoscopic-only repair of urethral stricture or bladder neck contracture using     a combination of existing surgical techniques of internal urethrotomy (or bladder neck     incision) augmented by buccal mucosal graft.   "
17097|NCT03061734|"     The objective of this study is to compare ALLOD-2 versus its components for headache pain and     for nausea to provide data to comply with the FDA's combination rule requirements.      The investigational product (ANODYNE-1), is a combination of two re-purposed marketed drugs     used for the acute treatment of migraine due to discovery of biologically and clinically     relevant affinity for new targets. Both drug are being re-purposed at a significantly lower     dosage compared to the maximum dose that has already been approved for the marketed     indications.      The combination is a First-in-Class drug due its new and unique mechanism of action.      The investigators propose that in predisposed individuals, migraine attacks occur due to     exuberant innate immune system activation nearby the trigeminal nerve and other cranial     nerves. The innate immunity activation leads to release of pro-inflammatory cytokines [nitric     oxide (NO), tumor necrosis factor-α (TNF-α), and reactive oxygen species (ROS)], and to COX-2     activation, which produces neuro-inflammation, causing pain and various migraine-associated     symptoms.      The investigation will focus on comparison of migraine-associated nausea, which has been     shown none-responsive to any of the other known migraine treatments, and is considered an     unmet treatment need.      ALLOD-2 reverses the neuro-inflammation through dual action, inhibition of the release of     pro-inflammatory cytokines and inhibition of the COX-2 activation. Efficacy of this product     for migraine headache pain and for migraine-associated symptoms, especially nausea, may     suggest the product addresses the root cause of migraine.   "
17098|NCT03061721|"     This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a     diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks     and will include a Screening Phase, a 16-week Treatment Phase following randomization.     Patients will be randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium     1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16     Weeks. The primary endpoint of the study is percentage change from baseline in serum ALT     levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group.   "
17099|NCT03061708|"     Phase II trial of AZD2014 in RICTOR amplified or overexpressed GC patients as second-line     chemotherapy AZD2014 50mg BD continuous schedule of a 28 day cycle   "
17100|NCT03061695|"     This observation study is to evaluate the application of the spectral analysis and     characteristic parameters of digitized respiratory sounds in the confirmation of the position     of the balloon of endobronchial blockers   "
17101|NCT03061682|"     Age related macular degeneration (AMD) is the leading cause of vision loss in patients older     than 55 years old. AMD can present as dry AMD or wet AMD. In most cases AMD affects both eyes     although in many cases it's asymmetrical as far as severity. Some patients require low vision     aids to continue their daily life tasks. In the past a few attempts were made to use low     vision intraocular lenses with corrective glasses without enough success. In addition     telescopic and prismatic lenses were also tried. The difficulties with these lenses included     low field of vision, unsatisfactory magnification, complicated surgical technique and high     complication rates.      Recently an add on lens was designed for the sulcus for implantation in pseudophakic AMD     patients. The add on lens doubles the magnification of the central image dependent on the     reading distance and the anatomy of the eye.      The lens is acrylic hydrophobic and designed for implantation in the sulcus either in     pseudophakic patients or in addition to an intraocular lens implanted during a routine     cataract surgery. The lens is 13 mm wide with 4 symmetric haptics. The lens has 1.5 mm     central part of 10 diopters and the rest of the lens has no optical power.      Our purpose is to study implantation of the lenses in AMD patients to improve their reading     ability and to improve their daily living.   "
17102|NCT03061669|"     Respiratory monitoring during right heart catheterization to differentiate between various     types of pulmonary hypertension; The effects of the cardiovascular system on the lung     mechanical properties.   "
17103|NCT03061656|"     The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCT     including high-dose 131I-metaiodobenzylguanidine (MIBG) treatment. In the present study, a     single arm trial of tandem HDCT/ASCT will be carried out.   "
17104|NCT03061643|"     Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with     Previously-Untreated, Metastatic, Prostatic Adenocarcinoma   "
17107|NCT03061604|"     INTRODUCTION Acute variceal bleeding (AVB) is a severe complication of portal hypertension in     patients with liver cirrhosis. The primary therapy includes the administration of vasoactive     drugs, antibiotics and endoscopic therapy; preferably esophageal banding ligation (EBL)     and/or cyanoacrylate injection when bleeding occurs from gastric varices.      In this context, the idea is to assess Hemospray (Cook Medical, Winston-Salem, NC) as an     initial therapy in patients with massive bleeding as a temporary bridge until definitive     treatment could be instituted.      The data generated from the pilot study performed between Erasme hospital, ULB and TBRI ,     Cairo showed that adding Hemospray as early as possible in the management steps could     increase the bleeding control rate up to 95 % at 24 hours.      OBJECTIVE The primary efficacy objective of this study is to assess the efficacy of Hemospray     in combination with standard of care (SOC) medical treatment compared to the efficacy of SOC     in the Control Arm in patient with acute variceal bleeding in cirrhotic patient.      The primary safety objective of this study is to evaluate the safety of Hemospray when used     in combination with SOC compared to SOC in the Control Arm.      1.1. Secondary:        -  To evaluate the effect of timing of Hemospray treatment on the outcomes of bleeding          patients        -  To evaluate the adverse effects on both therapeutic regimens (SAEs and clinically          significant AEs).   "
17108|NCT03061591|"     A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of     wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse     Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve     treatment with 8 capsuls (2*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or     placebo for six months.   "
17128|NCT03061331|"     This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study     that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who     have at least one A455E mutation.   "
17290|NCT03059212|"     Ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the     function of primary motor cortex and prefrontal cortex that play key roles in motor and     frontal memory processing is hypothesized in this study.   "
17109|NCT03061578|"     The study consists of 3 study visits to the clinic over at least 9 days. Visit 1 - the     medical screening visit: subjects will undergo informed consent and will be tested for signs     and symptoms of Dry Eye Syndrome (DES) including measurements by the TFI.      Upon conclusion of the screening for DES, the subjects will be divided to the different     categories: NDE, LDDE and ADDE. For ADDE and LDDE subjects the eye fitting the worst DES     inclusion criteria will be designated as the study eye. For the NDE subjects the best eye     will be designated as the study eye.      During Visit 2 and 3, the TFI measurement and other clinical study endpoint procedures will     be only conducted on the study eye. The safety endpoint procedures will still be conducted on     both eyes individually throughout the study. Subjects will be queried for adverse events     (AEs) at all visits.      Visit 2 - after two days washout period subject will return for the LH-EEC test. Signs and     symptoms of dry eye will be recorded before entering the LH-EEC, during the 120 min stay in     the LH-EEC and at the conclusion of the day.      Visit 3 - after 7 days washout period subject will return for the last test. The third day     procedure is identical to the second day, with the addition of: following LH-EEC exit,     subjects will have a health check and study check out procedures conducted.      Statistical Analysis:      Data will be summarized with respect to baseline characteristics, efficacy variables and     safety variables. Summary statistics will include the number of observations (N), mean,     standard deviation (SD), median, minimum and maximum values for continuous variables and     frequencies and percentages for categorical variables.      Missing values will not be replaced or imputed, i.e., no interpolation or extrapolation will     be applied to missing values.      Safety data will be listed and summarized by group (NDE, ADDE, and LDDE).   "
17110|NCT03061565|"     Traumatic brain injury is catastrophic event that commonly require treatment in an intensive     care unit. Management is mainly supportive aiming at avoiding hypoxia, hypotension,     hypoglycaemia and increased intracerebral pressure. Thus far efforts to find a specific     pharmacologic therapies have been disappointing. Recently it was demonstrated that     recombinant erythropoietin has been found to decrease mortality at six months from injury but     without significantly improving functional neurological outcome (GOSe). Whether this survival     benefit of EPO is sustained beyond 6 months is unknown.      In the current study survival data will be collected centrally and patients alive or person     responsible will be invited to participate in an evaluation of neurological function and     quality of life. Factors associated with time to death as well as factors associated with     long term quality of life will be determined with statistical methods.   "
17111|NCT03061552|"     Determination of dry weight in patients with end-stage renal disease treated with     hemodialysis is an unmet challenge in clinical nephrology. Current methods are imprecise, and     thus many patients are hype- or hypovolemic, and suffer respective consequences such as     hypertension, pulmonary congestion, cardiac hypertrophy, chronic dehydration, hypotension and     shock.      Several techniques have been proposed to asses hydration status in dialysis patient, among     them measurement of bioimpedance and biochemical markers. Sonographic measurement of the     inferior vena cava diameter (IVCD) is a method under investigation for assessing hydration     status. It is available, inexpensive and efficient, yet operator-dependent. In a     single-center, blinded and controlled trial it has been shown to improve clinical outcomes in     patients receiving hemodialysis.      In this study, we aim to assess the applicability and clinical utility of this method in our     dialysis units. A crossover design is intended to examine the effect of IVCD measurement on     quality of life and rate of hemodynamic adversities as compared with traditional estimation     of dry weight.   "
17112|NCT03061539|"     The primary objective is to test the following hypothesis: Patients with metastatic castrate     resistant prostate cancer that have progressed following at least one line of therapy and     have an immunogenic signature will respond to combined PD-1 and CTLA4 inhibition.   "
17113|NCT03061526|"     Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in     artery occlusions. Intracellular edema may develop and decrease transparency of those layers,     showing retinal edema. In spectral domain optical coherence tomography (SD-OCT) retinal     reflectivity changes as a result of retinal edema. The investigators examine the reflectivity     changes of different retinal layers between healthy eyes and eyes with retinal artery     occlusion and ischemic or non-ischemic vein occlusions. Aim of the study is to evaluate     whether those changes can be used to measure the level of ischemia in the inner retina.   "
17114|NCT03061513|"     The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the     symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be     randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic     resonance spectroscopy (MRS) and blood test for biological markers taken during the study.   "
17115|NCT03061500|"     An observational, prospective study whose main objective is to measure the value of     Pro-adrenomedullin as a prognostic marker and predictor of mortality in patients with     intra-abdominal sepsis after damage control surgery.   "
17283|NCT03059303|"     The purpose of this study is to assess the relative bioavailability of single-dose Simeprevir     (SMV), Odalasvir (ODV), and AL-335 when administered as a fixed-dose combination (FDC)     compared with the single agents when administered together, and to assess the effect of     multiple-dose lansoprazole and omeprazole on the single-dose pharmacokinetics (PK) of SMV,     ODV, and AL-335 when administered as an FDC.   "
17116|NCT03061487|"     The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the     pathogenetical mechanism of the aneurysmatic connective tissue degeneration. The increasement     of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen     and elastin tissue and serum levels.Matrix Metalloproteinases (MMPs) are a group of     proteolytic enzymes that along with their specific and non-specific inhibitors modulate the     extracellular matrix composition. Recent studies have suggested an interesting role of     microRNAs (miRNAs) in the regulation mechanisms of inflammation.      The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease     by monitoring MMPs and miRNAs in aneurysmatic wall tissue and MMps blood levels.   "
17117|NCT03061474|"     The purpose of this research study is to test whether nicotinamide, also known as vitamin B3     or niacinamide, taken in high doses, can reduce phosphorylation of tau (the protein that     accumulates in neurofibrillary tangles) in people with Mild Cognitive Impairment or mild     Alzheimer's disease (AD) dementia.   "
17118|NCT03061461|"     This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as     performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of     chronic soft tissue wounds, and is statistically significantly more effective than     sham-treatment of chronic soft tissue wounds.   "
17119|NCT03061448|"     The purpose of this study is examine if an internet-based exposure therapy based on     inhibitory learning is feasible, acceptable and effective in reducing panic symptoms amongst     patients who suffer from panic disorder and agoraphobia.   "
17120|NCT03061435|"     Almost half of all women will develop an HPV infection in their lifetime. While most     infections are naturally asymptomatic or cleared by the immune system, some persist and can     lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening     regimens for these lesions are currently only in place for the cervix through regular Pap     tests. These Pap tests usually involve an examination of the vulva -however, no screening     procedures exist for anal cancer for women. Several studies have suggested that women with     existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here     the investigators propose a multi-center study which seeks to screen for and treat anal     cancer in women over the age of 40 with vulvar lesions and a stable immune system. The     investigators will achieve this through performing anal Pap smears on eligible women and     conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with     abnormal anal cells. With enough evidence, there may be an indication to establish regular     anal cancer screening measures in this potentially underserved population.      Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or     VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and     11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine     anal screening regimens in Ontario and help shift health policy to treat this population.   "
17121|NCT03061422|"     36 eligible participants will be randomly divided into three groups (n=12) according to the     tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum,     (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3)     represents control group where participants are exposed to paraffin pellet chewing. The pH of     saliva will be evaluated according to time in relation to the gum chewing (T) where (T0)     represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of     the day (in the morning from 10 to 11 am).      Direct benefit of the research to the human volunteer:      It is important for high caries risk patients to decrease caries susceptibility as this will     eventually decrease their dental treatments and subsequently the treatment cost.      Scientific value and social benefits:      This study will benefit the dentist as the main goal of a dentist is to prevent rather than     cure. Also, it will decrease the restorative work carried out by dentist and save this time     for educating more patients about caries prevention methods.      Expected risk to the human subjects:      Allergic reactions due to any of the components of the materials used which is rare to occur.   "
17122|NCT03061409|"     Nutrient intake through diet and nutritional supplements are critical determinants of plasma     nutrient status. In addition, untoward drug-nutrient can contribute to nutritional     inadequacy. Among medications used by the elderly in the US, diuretics, metformin, and proton     pump inhibitors (PPIs) are ranked among the most commonly prescribed. Use of these     medications is variously associated with inadequate status of many micronutrients, e.g.,     vitamins B1, B9 (folate), B12, C, and thiamine and the minerals calcium, iron, potassium,     magnesium, and zinc. While diets rich in whole grains, fruits, and vegetables can help     decrease the risk for micronutrient inadequacy in older adults using one or more of these     drugs, supplementation may prove more effective to restoring and/or enhancing their nutrient     status. When compared to a placebo, investigators hypothesize that a     multivitamin-multi-mineral (MVM) supplement will improve nutritional status in older adults     at increased risk of micronutrient inadequacy induced by drugs commonly used by this     population, specifically diuretics, metformin, and PPIs. Investigators also hypothesize that     MVM supplementation will beneficially modify selected biomarkers or biochemical pathways of     cellular function/health. To test these hypotheses, investigators will conduct a randomized     clinical trial by pursuing the following specific aims: 1) To determine the extent by which     MVM supplementation (compared to placebo) will increase the plasma status of vitamins B12, C,     D, folic acid, and thiamine and the minerals iron, magnesium, potassium, and zinc; 2) To     quantify indices of 'metabolic health' including one or more of the following biomarkers:     glutathione/oxidized glutathione (GSH/GSSG ratio), ubiquinol/ubiquinone, malondialdehyde     (MDA), asymmetric dimethyl arginine (ADMA), selected cytokines and chemokines, homocysteine,     methylmalonic acid (MMA).   "
17123|NCT03061396|"     The purpose of this study is to clarify whether the matching acupoints are more effective     than a single point by electro-acupuncture in the management of chemotherapy-induced nausea     and vomiting.   "
17124|NCT03061383|"     This is a randomized, triple-blind, placebo-controlled study. 51 subjects with a confirmed     diagnosis of dentin hypersensitivity were randomized to one of three treatments: Arginine     based toothpaste, strontium acetate based toothpaste , or placebo. Treatment will be done at     baseline then patients will use the toothpaste at home twice per day by using soft bristled     tooth brush and the given dentifrice using modified stillmans method as explained by     examiner. Standard test stimuli is calibrated short blast of air syringe, will be applied to     sensitive dentin surfaces. Subjects recorded the intensity of sensitivity in response to     stimulus on a visual analog scale at baseline, and after 1 week, 2 weeks and 3 months.   "
17323|NCT03058783|"     Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic     Dermatitis in Pediatric and Adult Subjects   "
17324|NCT03058770|"     A prospective, randomized double-blind clinical trial will be conducted to determine the     effect of a sensorimotor retraining program on the sensory and functional recovery of the     paretic lower limb of subjects with chronic sequelae from stroke.   "
17125|NCT03061370|"     In line with improvements in oncologic outcome for patients with esophageal cancer, the     attritional impact of curative treatment with respect to functional status and health-related     quality of life (HR-QL) in survivorship is increasingly an important focus. Functional     recovery after surgery for esophageal cancer is commonly confounded by anorexia and early     satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss.     One in three disease-free patients has more than fifteen percent body weight loss at three     years after esophagectomy.      The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined     sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men,     while similar cut-off points have been validated in upper gastrointestinal and respiratory     malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working     Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should     also include determination of muscle function, for example gait speed or grip strength, where     possible.      The presence of sarcopenia is associated with increase treatment-associated morbidity,     impaired HR-QL, reduced physical and role functioning, and increased pain scores in older     adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL     over a six year period in older adults was accelerated in the presence of sarcopenia. As     such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of     HR-QL and functional status, and may reinforce a persistent illness identity, among patients     following potentially curative treatment for esophageal cancer.   "
17129|NCT03061318|"     A clinical trial is proposed, to clinically validate the diagnostic performance of a new     genetic test developed in Chile. It will determine the nature of thyroid nodules that have     been informed as indeterminate by cytology through a fine needle aspiration (FNA).      The Genetic Classifier for Indeterminate Thyroid Nodules is a quantitative gene expression     test, that combines the results for a panel of 10 biomarkers (CXCR3, CCR3, CXCl10, CK19,     TIMP1, CLDN1, CAR, XB130, HO-1 and CCR7), to generate a single number score. It is indicated     on patients with a thyroid nodule informed by cytology as indeterminate (Bethesda III and IV,     according to The Bethesda System for Reporting Thyroid Cytopathology). This test would be     used by taking a sample with a fine needle aspiration (FNA) and thus, being able to predict,     with high accuracy, benign nodules that do not require surgery.   "
17130|NCT03061305|"     Many patients are treated for advanced cancer without knowledge of underlying molecular     features that might indicate FDA approved therapies or potential eligibility for     biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial     (STR-001-001) with the primary goal of understanding the proportion of subjects available for     clinical trials and approved targeted therapies in advanced cancer while assessing the     feasibility of using a large-scale NGS screening program to match subjects for eligibility     assessments in clinical trials and/or for approved targeted therapies. The Strata Trial does     not require additional procedures but rather uses surplus, or leftover tumor specimens for     molecular profiling.   "
17131|NCT03061292|"     Implantation of cardiac implantable electronic devices are generally carried out using     intermittent intravenous conscious sedation combined with local anaesthesia. The main     advantage of this technique is in avoiding the potential risks of general anaesthesia.     However, the use of this Sedation - Local Anaesthesia technique is not without complications.     Peri -procedural hypoxaemia and hypotension are well recognised complications of this     technique.      The pectoral nerves (Pecs) blocks are novel techniques to block the pectoral,     intercostobrachial, third to sixth intercostals, and the long thoracic nerves. PECS block     targets the lateral and median pectoral nerves at an interfascial plane between the     pectoralis major and minor muscles.      A case report by Fujiwara et al has described the use of this technique to provide good     analgesia during and after these implantation procedures surgery. Pectoral nerves block along     with minimal sedation has been used as a safe technique in our local set up as well.      Hence, we propose a randomized, single center, controlled trial on patients undergoing     cardiac implantable electronic device implantation with local anaesthesia and sedation with     and without Pectoral Nerve Block.   "
17132|NCT03061279|"     The purpose of this study is assess the safety and efficacy of Acutrak headless screws in     comparison to other fixation methods (traditional headed screws, plates, and wires) used in     the treatment of medial malleolus fracture of the ankle joint.      The investigators hope to learn the following objectives from this study        1. Prospectively establish equivalence with respect to fracture union rate after Acutrak          headless compression screw fixation when compared to other fixation methods for medial          malleolus fractures.        2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement          Information System (PROMIS) scores after Acutrak headless compression screw fixation          when compared to other fixation methods for medial malleolus fractures.        3. Prospectively establish superiority with respect to hardware related pain after Acutrak          headless compression screw fixation when compared to other fixation methods for medial          malleolus fractures.        4. Prospectively establish superiority with respect to the hardware removal rate after          Acutrak headless compression screw fixation when compared to other fixation methods for          medial malleolus fractures.      Patients scheduled for open reduction and internal fixation for medial malleolus fracture by     using Acutrak headless screw or any other method will be asked to enroll by the attending     physician, and those patients will be asked to consent to the study. Patients will be     randomized by sealed envelope to surgical fixation with traditional headed screws, plates,     and wires or Acutrak headless compression screws. At the time of randomization, the fracture     pattern and severity, past medical history and medications, and demographic data will be     documented. After operative fixation, patients will receive routine fracture follow-up with a     clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete     the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6     months, 1 year, and 2 years after surgical fixation   "
17247|NCT03059771|"     Motivation deficits are a strong determinant of poor functional outcomes in people with     schizophrenia. Mobile interventions are a promising approach to improving these deficits, as     they can provide frequent cues and reinforcements that support goal-directed behavior. The     primary aims of this study are to conduct a pilot study using a randomized design to 1) Test     the feasibility and acceptability of a personalized mobile text message intervention, Mobile     Enhancement of Motivation in Schizophrenia (MEMS) and to 2) Test the preliminary     effectiveness of MEMS compared to a control condition.   "
17133|NCT03061266|"     This study will be a randomized controlled trial aimed at examining the effectiveness of the     in e-health education on shared care program for patients with type 2 diabetes mellitus     (T2DM). The experiment will be conducted over 1 year at a regional hospital in Taiwan. The     research subjects will be excluded 160 patients with T2DM. Subjects assigned to an     experimental group will receive the integrated care program, whereas those assigned to a     control group will receive routine care. The membership of e-health education on shared care     program is established by different type's professionals including diabetes physicians,     pharmacists, dietitians and diabetes health teacher. Glycated hemoglobin (HbA1c) of subjects     in both groups will be measured at three time points including 1 month before the experiment,     and 2 and 5 months after the experiment. The self-management conditions and quality of life     of the subjects will be also recorded using relevant scales.   "
17134|NCT03061253|"     The large current uptake of e-cigarettes (2.8 million U.K. users in 2016; 26), the continuous     involvement of e-cigarettes (which potentially affects their contents as well), the     uncertainty about their medium- and longer-term effects, and the need to promote smoking     cessation as means of reducing Cardiovascular disease, dictate that more research is urgently     needed. Research exploring the impact of e-cigarettes on cardiovascular function/ health has     been requested by the European Parliament, the British Medical Association, regulatory     agencies, clinicians and researchers, as there is currently no consensus within the smoking     cessation community as to the potential impact of e-cigarettes. With e-cigarettes being     successful in replacing traditional cigarettes (i.e. up to 42% within a month), such studies     should not only be efficacy-focused, but should also explore the physiological effects of     e-cigarettes, as preliminary work in the field is contrasting and limited, in both the acute-     and longer-term timeframe. Furthermore, as e-cigarettes are not simple nicotine-based     products, the general public, researchers and government agencies cannot rely on the existing     research exploring the effects of nicotine on the cardio-vasculature (e.g. coronary and     peripheral vasoconstriction, intravascular inflammation and deregulation of cardiac autonomic     function as well as inhibition of microcirculation). Thus, the lack of direct evidence -     which would clarify the degree of safety of e-cigarettes for the user's vascular system and     determine their longer-term cardiovascular disease risk - increases the need for research in     the field.      Such studies will supply in-depth information to service-users and policy-makers, especially     as the recently-initiated U.K.'s Medicines and Healthcare Products Regulatory Agency     validation of e-cigarettes will increase likelihood of their introduction in smoking     cessation clinics.      This study will bridge the existing knowledge gap and inform the general public, the     scientific and the smoking cessation community in respect to the physiological (e.g.     cardiovascular health) and participants' experience of both nicotine-inclusive and     nicotine-free, e-cigarettes (when combined with behavioural change support) and compare it     against a currently NHS-applied smoking cessation pathway that combines Nicotine Replacement     Therapy and behavioural change support. This will allow future research to advance and     optimize the pharmacological treatment of tobacco and nicotine dependence, by taking into     consideration the study's physiological and Health Economics' findings.   "
17135|NCT03061240|"     This study is the second phase of a research project called Smart Pain Assessment Tool based     on Internet-of-Things. During the course of this project, a smart pain assessment tool (SPA)     to detect and assess pain employing behavioural and physiologic indicators will be developed.     We aim to assess pain based on changes in electromyographic (EMG) activity in facial muscles,     i.e. changes in facial expressions and simultaneously use physiologic signs such as heart     rate, respiratory rate and galvanic skin response as adjuvant measures to develop an     algorithm for pain assessment in critically ill patients.   "
17136|NCT03061227|"     The investigators previously characterized a phenotype with non-suppressed glucagon at 120     minutes after standardized oral glucose load. This phenotype is associated with healthy     metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content.     Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous     glucose production, also reduces appetite and increases basal energy expenditure. The aims of     this study are to i. detect functional differences in the appetite-related central nervous     system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick     the non-suppressed glucagon phenotype in those participants who suppress glucagon by     administering a very-low-dose glucagon infusion and retest them.   "
17138|NCT03061201|"     The purpose of the study is to evaluate the safety, tolerability and time-course profile of     FVIII activity levels with adaptive doses of SB-525.   "
17139|NCT03061188|"     The purpose of this research study is to determine the highest and safest dose of the     experimental drug veliparib when combined with nivolumab. We will also study how safely this     combination of medication can be given in advanced cancer and lymphoma and benefits of     receiving this therapy. Nivolumab is currently approved in certain cancers such as melanoma,     lung cancer and kidney cancer. Veliparib is not yet approved for use in the United States,     and is considered experimental. Veliparib inhibits (blocks) the activity of the enzyme PARP.     This blocking activity may prevent the cancer cell from repairing itself and resume growing.     Nivolumab increases T cells in your immune system, which allows your immune system to attack     the cancer. We think the combination of these drugs will be more effective against your     cancer.   "
17140|NCT03061175|"     This pilot randomized clinical trial studies how well a web-based decision aid works in     improving informed decisions in patients with stage 0-IIIA breast cancer considering     contralateral prophylactic mastectomy. A web-based decision aid may help doctors determine     how patients make decisions about whether or not to have contralateral prophylactic     mastectomy.   "
17141|NCT03061162|"     This phase II trial studies the side effects and response of pulsed low dose rate radiation     therapy in treating gastric cancer patients with peritoneal metastasis.   "
17142|NCT03061149|"     Carpal tunnel syndrome is considered to be the most common entrapment neuropathy.     Conservative treatment is recommended in the mild and moderate stage of CTS. The aim of this     trial is to evaluate the effectiveness of physical therapy modalities in carpal tunnel     syndrome.   "
17143|NCT03061136|"     Cognitive deficits are some of the most prominent and disabling symptoms of schizophrenia.     Evidence suggests that schizophrenia involves alterations to the functioning of a neural     system under the control of a brain chemical called GABA. The present project will compare     the effects of low-dose clonazepam (at a sub-sedating dose) to placebo, for effects on GABA-     modulated brain activity measured by EEG, and associated cognitive processes in people who     have schizophrenia.   "
17325|NCT03058757|"     The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical     mitomycin-C instillation in non-muscle invasive bladder cancer patients   "
17326|NCT03058744|"     Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects     with Moderate to Severe Plaque Psoriasis.   "
17144|NCT03061123|"     The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral     anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to     the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder     and understanding the benefits and hazards of antithrombotic treatment are essential to     incorporate patient´s values and preferences in these decisions. This will further improve     acceptance of recommended therapy and augment compliance with OAC.      The objective of this investigation is to compare patient´s perceptions and physician´s     assessments of benefits and risks of OAC.   "
17145|NCT03061110|"     Prospective, single center, double armed, randomized treatment with observation only     (standard of care) control group. Subjects receiving study treatment will have 6 months of     study follow-up. Stromal vascular fraction (SVF), an adipose-derived tissue preparation, will     be injected into salivary glands to determine safety and efficacy to restore saliva     production in head and neck cancer patients with chronic xerostomia resulting from radiation     therapy.   "
17147|NCT03061084|"     A transitional Urology database was created in parallel with National Spina Bifida registry     to follow patients with complex congenital urogenital anomalies and be able to prospectively     evaluate them. The investigators obtained the standardized questionnaires to collect     long-term data regarding patients' genitourinary status including urine and fecal continence,     sexuality, fertility, and pelvic health.   "
17148|NCT03061071|"     This study is a prospective, multi-center, randomized crossover of the NightBalance SPT     compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).   "
17149|NCT03061058|"     Tumor messenger ribonucleic acid (mRNA) expression levels may have a promising role as     potential predictive biomarkers for chemotherapy.      Peritoneal carcinomatosis appears to be the most common pattern of metastasis or recurrence     and is associated with poor prognosis in gastric cancer patients. Intraperitoneal     chemotherapy is widely accepted strategy in the treatment of peritoneal dissemination.      In this study, our aim is to evaluate the impact of individualized selection of     chemotherapeutics and intraperitoneal combined with system chemotherapy on overall survival,     disease free survival, response rate, and safety of advanced gastric cancer patients.   "
17225|NCT03060070|"     Comparing the analgesic effects of ketamine and dexmedetomidine when added to local     anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.   "
17226|NCT03060057|"     The purpose of this study is to evaluate both short and long term clinical performance and     safety of the commercially available U2 Knee™ System.   "
17150|NCT03061045|"     The aim of the proposed project is therefore to utilize the CEUS technique to assess cerebral     perfusion changes before and after ventricular shunting in neonatal cases of PHH. The     expectation of the proposed project is to validate statistically significant cerebral     perfusion differences before and after shunting in neonates with PHH, as a preliminary     feasibility study prior to conducting a large scale, prospective clinical trial incorporating     therapeutic interventions using the CEUS technique.   "
17151|NCT03061032|"     Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is     one of the public health problems resulting in chronic liver disease, cirrhosis and     hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to     prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was     not efficient in all cases and results in numerous number of side-effects. Introduction of     direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication     of HCV possible however these regimens are not affordable and available in developing     countries. The generic DAAs are manufactured in many of these countries such as Iran to     provide the treatment with reasonable price.   "
17152|NCT03061019|"     Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep     apnea. As the effectiveness of reeducation relies on parental involvement and child's     compliance, the investigator's research question was to evaluate two methods of myofunctional     therapy (daily oral exercices versus a flexible oral appliance, both in combination with     nasal hygiene), compared to nasal hygiene alone (control group).   "
17153|NCT03061006|"     Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated     anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial     fibrillation will be considered for study. After written informed consent is obtained,     subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1:     Dabigatran etexilate (150 mg BID if CrCL > 30 mL/min, or 75 mg BID if CrCL > 15 to 30 mL/min     or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney     function every 6 months will be done for Group 1. Standard warfarin follow-up and education,     based upon system criteria, will be done for Group 2. All subjects will be followed for 24     months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months     post-anticoagulation visits as well as other visits deem necessary for clinical care. All     subjects will undergo protocol-specified laboratory tests and will complete 6 standard,     validated questionnaires at each follow-up visit following the week 1 visit, except at the     3-month visit when only one questionnaire will be administered. To determine brain volume and     characteristic changes representative of micro-bleeding, the first 10 subjects in each     treatment group who are willing and able to undergo the procedure will participate in a MRI     sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on     this sub-group.   "
17154|NCT03060993|"     A growing body of physiological evidence now exists to support a potential role for inhaled     cannabis in the medical management of adults with chronic obstructive pulmonary disease     (COPD), particularly as it may related to improving pulmonary function, alleviating the     symptom of breathlessness and improving exercise endurance. The purpose of this randomized     double-blind crossover trials is to evaluate the efficacy and physiological mechanism(s) of     action of inhaled vaporized cannabis targeted to relief of physical activity-related     breathlessness and exercise endurance in symptomatic patients with severe-to-very severe     COPD.   "
17155|NCT03060980|"     A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of     ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in     patients with Type 2 diabetes.   "
18138|NCT03048110|"     Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of     BAY1841788 (ODM-201)   "
17156|NCT03060967|"     Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of     16-17% in the general population. Although its pathophysiology is not completely understood,     a large body of literature pleads for a causative role of disturbances in reward processes,     referring to: i) the hedonic sensation (i.e. liking) defined by the pleasure felt after     exposure to appetitive stimuli, and ii) the motivation (i.e. wanting) represented by the     ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. the     investigators have therefore developed and tested a new experimental computer-based and     easy-to-use test intended to provide an objective and quantitative measurement of both     hedonic and motivational states in humans. According to the task, the subjects are asked to     view and to compare two stimuli, an appetitive one (food pictures) and its devalued     counterpart (food pictures in greyscale), at each trial, assessing either the size (task A)     or the duration of presentation (task B). From these considerations, the present project aims     at using our novel tool to: i) assess the hedonic and motivational state in subjects with     major depression, ii) compare their responses with healthy volunteers. The present project     should demonstrate that the behavioral tests validated in our laboratory are relevant     experimental tools for the diagnostic/clinical assessment and for the phenotypic     characterization of depressed patients. The application of the test in the therapeutic     context could add further information about the efficacy and relevance of the chosen therapy.   "
17157|NCT03060954|"     Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority     trial   "
17158|NCT03060941|"     A randomized multi-component physical activity intervention for breast cancer survivors.   "
17159|NCT03060928|"     Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator     Cuff Repair with standard treatment compared to patients receiving biological stimulation     with micro-perforations or with the combination of micro-perforations and use of Artelon®     Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.      The investigators believe that this kind of tendon-to-bone healing stimulation with the two     proposed methods can increase the repair quality by significantly decreasing the lesion     recurrence rate (currently described for 15% of patients) and can improve various parameters     such as pain, range of motion and strength, thereby hastening the return to daily activities     and psycho-physical well-being.   "
17160|NCT03060915|"     Those patient's that come to the sleep unit and that accept to participate in the study will     undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm     wrist. The outcomes that will be analyzed are:      Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's     on/light's off   "
17161|NCT03060902|"     Offspring of mothers with Borderline Personality Disorder (BPD) are at serious risk for     developing mental illness at every stage of their life, and yet little is known about how     this risk is transmitted. This study will leverage Dialectical Behavior Therapy Skills as an     experimental intervention to determine if preschool emotion regulation develops more rapidly     as a result of improvements in mothers' ability to regulate her own emotions. The knowledge     from this study will identify a modifiable pathway by which maternal BPD places offspring at     risk for later mental disorders and will quantify how much improvement in children's ability     to regulate their emotions can be achieved by treating mothers alone.   "
17162|NCT03060889|"     Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa   "
17163|NCT03060876|"     This register study collects data of patients with proximal humerus and humerus shaft     fractures to monitor the healing process by assessing shoulder function and quality of life     according to the treatment method (operative or conservative management).   "
17164|NCT03060863|"     The goal of this project is to measure childhood self-regulation targets known to be     associated with obesity risk and poor adherence to medical regimens and to assess whether     intervening on these mechanisms can improve self-regulation. The investigators will do so in     a pre-existing cohort of low-income school-age children.   "
17165|NCT03060850|"     This is an open label, dose escalation, phase I study to determine the recommended Phase 2     dose (PR2D) by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell     lymphoma.   "
17166|NCT03060837|"     In patients undergoing RIRS for kidney stone, we aim to show the effect of single lung     ventilation with a double lumen tube on operative (operation scope duration, perforation,     hemorrhage, etc. complications) and postoperative parameters (stone-free rates, complications     like postoperative hemorrhage and fever, hospital stay, etc.) and to show changes in renal     stone position during simultaneous normal ventilation and single lung ventilation.   "
17167|NCT03060824|"     During the use of Cardiopulmonary Bypass (CPB) for cardiac surgery there is an instant     mixture of the patient's blood and the fluid needed to fill the extracorporeal circuit before     use. This will change the composition of the body fluids. This study aims to plot these     changes in regard to particle concentration (osmolality).   "
17168|NCT03060811|"     Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and     seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and     carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was     previously reported to be associated with an elevated risk for cardiovascular events.      Aim of this study was to investigate the association between plasma levels of TMAO with the     Mediterranean diet in a cohort of healthy adults.   "
17169|NCT03060798|"     General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity.     However, the differences in microcirculation caused by anesthetic methods have not been well     studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation     noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The     purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation     (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy     population.      This prospective, observational study will be performed on 57 healthy patients who had     undergone elective surgery under volatile general anesthesia. The investigators measure StO2     and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The     parameters were performed twice per patient, before and after the induction of anesthesia.      Occlusion slope and recovery slope during VOT will be compared before and after anesthesia.     Moreover, the changes depend on the age will be analyzed.   "
17171|NCT03060772|"     This study is a single center, open-label, randomized clinical trial to determine the effect     of pioglitazone (PIO) treatment on alveolar macrophage immune function, redox stress, and     NADPH oxidase expression in outpatient alcoholic subjects. The researchers will recruit a     cohort of otherwise healthy patients with an alcoholic use disorder from the Substance Abuse     Treatment Program at the Atlanta Veterans Affairs (VA) Medical Center and randomize them to     receive the usual treatment for two to four weeks or to the usual treatment plus PIO     treatment for two to four weeks. There will also be a healthy control group (matched on age,     gender, and smoking status) that will receive no treatment. To measure the effect of     pioglitazone, participants will undergo a bronchoscopy before taking the study drug and then     again 2-4 weeks later to look for changes. The bronchoscopy will allow researchers to obtain     fluid from the lungs to see how well their immune cells respond to bacteria by determining     phagocytic capacity.   "
17172|NCT03060759|"     This prospective study will randomize 1:1 people living with multiple sclerosis-associated     fatigue to one of two spectra of light therapy. Each participant will be asked to use the     light box twice daily at home or at the workplace at preset hours during the day for a total     of four weeks. Participants will be asked to record their fatigue on standard measurement     scales before, during, and after the use of the light therapy box. The investigators     anticipate a reduction in self-reported fatigue following the use of the light box therapy of     a particular spectrum of light among people living with multiple sclerosis.   "
17173|NCT03060746|"     The primary objective is to obtain stool samples from pre-therapy subjects already undergoing     evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric     biopsy.   "
17174|NCT03060733|"     The primary objective is to obtain stool samples from post-therapy subjects already     undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD)     and gastric biopsy.   "
17175|NCT03060720|"     This research study is looking at people with cancer of the pancreas to find clinical factors     that can explain the presence of genetic mutations   "
17176|NCT03060707|"     The research is to find out whether continuous infusion of rocuronium requires more or less     amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during     noncardiac surgery.   "
17177|NCT03060694|"     The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in     non-diabetic patients.   "
17227|NCT03060044|"     Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus     50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in     healthy subjects   "
17178|NCT03060681|"     The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar     spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial     techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the     use of systemic opioids, Paracetamol, non-steroidal anti-inflammatory drugs (NSAID), steroids     and gabapentinoids .      In 2015, a promising regional analgesia technique was reported, that targets the dorsal,     rather than ventral, rami of the thoracolumbar nerves as they pass through the paraspinal     musculature, and called this a thoracolumbar interfacial plane block (TLIP).   "
17179|NCT03060668|"     In this prospective randomized controlled trial the investigators intend to compare the use     of a nutritional therapy based on caloric intake determined by indirect calorimetry and a     high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day     and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).   "
17180|NCT03060655|"     The different proportion samples of PLGA-Mg were made in this study. Then, they would be     placed in the femoral condyle of the New Zealand rabbits. The appropriate proportion of     PLGA-Mg is obtained after the experiment, which will be used to make the plate or screw to     fix the fragments. Then, the clinical role for bone will be assessed.   "
17181|NCT03060642|"     This study aims to elucidate the relationship between the microbiome, inflammation, and the     microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the     end goal of developing a non-endoscopic testing strategy based on pathogenic factors to     identify patients at highest risk for EAC. To accomplish this the investigators will enroll     100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing     upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive     potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled     volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers).     The study will evaluate these novel tests in combination with clinical and anthropometric     factors to describe an optimal strategy for BE screening and monitoring.   "
17182|NCT03060629|"     The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety     and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and     aluminum-phosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV)     infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1     infections diagnosed between the Month 7 and Month 24 visits.   "
17183|NCT03060616|"     The principal manifestation of hemorrhoidal disease is bleeding; however the severity     evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not     included.      Even if there was some rare score including bleeding in literature , none of them were     validated.      The aim of the study is first validation of bleeding score .   "
17184|NCT03060603|"     The purpose of this study to assess the proliferative effects of erythropoetin on human     endometrium tissue by measuring the endometrial thickness, uterine artery and subendometrial     blood flow in postmenopausal women.   "
17198|NCT03060421|"     As the use of Aquamid Reconstruction as an intraarticular device on humans is a relatively     novel treatment, it is relevant to assess the safety profile of the device in a safety study     to evaluate the safety of the device.      This is a retrospective single center cohort study of patients with osteoarthritis of the     knee(s) that have been treated for knee OA referred to a clinical evaluation at our     department.      The study consists of one clinical visit, at which the patients medical history will be taken     and upon informed consent adverse events data is collected from medical records.      The study is retrospective.   "
17393|NCT03057873|"     The objective of this study is to investigate the effect of a high protein, high fiber     dietary supplement on weight and fat loss in healthy overweight adults. Half of participants     will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the     subjects will receive a placebo (that contains the same amount of calories as the supplement)     twice a day for 12 weeks.   "
17185|NCT03060590|"     Background. In advanced chronic kidney disease (CKD), multiple metabolic and nutritional     abnormalities may contribute to the impairment of skeletal muscle mass and function thus     predisposing patients to the condition of sarcopenia. Herein, we aim to investigate the     association of uremic toxins and sacropenia. In addition, the prevalence and mortality     predictive power of sarcopenia, defined by different methods, in a cohort of hemodialysis     patients.      Methods. We plan to evaluate 300 HD patients. Sarcopenia was defined as reduced muscle     function assessed by handgrip strength (HGS <30th percentile of a population-based reference     adjusted for sex and age) plus diminished muscle mass assessed by different methods: (i)     midarm muscle circumference (MAMC) <90% of reference value (A), (ii) muscle wasting by DEXA     (B) and (iii) reduced skeletal muscle mass index (<10.76 kg/m² men; <6.76 kg/m² women)     estimated by bioelectrical impedance analysis (BIA) (C). Serum levels of 3 established uremic     toxins such as indoxyl sulfate, p-cresol and hippuric acid will be measured. Besides, various     relevant inflammatory markers will also be assessed. Patients will be followed for up to 3     years for all-cause mortality.   "
17186|NCT03060577|"     ORION-3 is a Phase II, open-label, non-randomized, active comparator extension trial to     assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and     evolocumab given as subcutaneous injections in participants with high cardiovascular risk and     elevated low-density lipoprotein cholesterol (LDL-C).   "
17187|NCT03060564|"     To evaluate patient function, radiographic changes and complication rates of acute     coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an     augmentation to repair.   "
17188|NCT03060551|"     This study outlines the safety of the autologous SVF cells injection in the hands of patients     with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing     confirmation in a randomised placebo-controlled trial on a larger population   "
17189|NCT03060538|"     This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending−dose study of     the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A     in participants with Type 2 diabetes mellitus. A maximum of approximately 140 participants     will be enrolled across multiple sites in the United States. Participants will be randomly     assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a     screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period.     Participants may come to clinic for an optional pre-screening visit.   "
17190|NCT03060525|"     The purpose of the Deaf Weight Wise 2.0 (DWW 2.0) study is to test an evidence-based,     comprehensive program to modify obesity-related health behaviors with Deaf people ages 21 to     70 who use American Sign Language (ASL) as their primary language. Participants will be     randomized to one of four arms: immediate intervention vs. intervention delayed one year, and     in-person group intervention vs. individual intervention delivered via videophone. The     investigators' primary hypothesis is that participants in the immediate DWW 2.0 intervention     will increase their physical activity and reduce their caloric intake and body weight     compared with those in the delayed intervention group (no intervention yet).   "
17191|NCT03060512|"     The purpose of this study is to determine whether patients with opioid induced constipation     prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.   "
17192|NCT03060499|"     Protocol Synopsis      Protocol title: Post thyroidectomy myocardial function Purpose: Evaluation of the effects of     total thyroidectomy on myocardial function Design: Prospective, single-center, cohort study     Patient Population: Male or female subjects 18 years of age or older who are scheduled for     total thyroidectomy No. of Subjects: 50 patients, estimated up to 12 months to enroll     Duration of Treatment: Operation Duration of Follow-up: After discharge, the patients will be     re-evaluated at three (3), six (6) and twelve (12) months in the outpatient clinic.      Endpoints: To evaluate the changes in the myocardial function after the removal of the     thyroid gland.   "
17193|NCT03060486|"     Blood contamination, such as apical microleakage, of root canal during preparation can be a     major problem in endodontics. The purpose of this investigation was to evaluate the     hemostatic properties of sulfonic/sulfuric acid solution used during root canal therapy in     teeth with irreversible pulpitis.   "
17194|NCT03060473|"     Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This     pregnancy complication is a major contributor to preterm births and results in neonatal     morbidity and mortality. The current standard of care for PPROM subjects between the     gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin     and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do     not tolerate this regimen over the course of 7 days. In addition, there is a national     shortage of erythromycin, and published expert opinion proposed to use a second-generation     macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is     cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective     is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The     investigators' working hypothesis is that there is no measurable difference in the primary     outcome between the group randomized to the azithromycin regimen versus the group randomized     to the erythromycin regimen.   "
17195|NCT03060460|"     The study evaluates whether routine use of ultrasound for sheath insertion during radial or     femoral angiography or angioplasty has any impact on: number of punctures, patient     discomfort, procedural length, successfull procedure or ideal vessel puncture.   "
17196|NCT03060447|"     The primary objective of this study is to evaluate the safety and tolerability of a 10-dose     regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and     during analytical treatment interruption (ATI) following vesatolimod dosing.   "
17197|NCT03060434|"     The objective of this prospective controlled crossover study is to evaluate the efficacy and     safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy   "
17199|NCT03060408|"     In this retrospective cohort study, the investigators reviewed and analyzed the electronic     medical records of consecutive patients who underwent distal pancreatectomy either via     laparotomy or laparoscopy. Intraoperative fluid administration amount, postoperative     complications, length of hospital stay, and readmission rate were evaluated. The total fluid     amounts were calculated using the sum of colloids multiplied by 1.5 or 2.0 and crystalloids.   "
17200|NCT03060395|"     There is increasing evidence that a number of people experience moderate milk intolerance     characterised by increased gas production, bloating and abdominal cramp, which can neither be     attributed to lactose intolerance, nor to milk protein allergy. Milk digestion can lead to     the formation of bioactive peptides, one of which derived from a mutated gene variant (A1)     coding for milk beta-casein has been associated with increased gastrointestinal inflammation     and poor gastrointestinal function. In this study, we hypothesise that consumption of     non-mutated A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant     individuals.   "
17201|NCT03060382|"     The investigators randomly divided the knee osteoarthritis patients met the inclusive     criteria into two groups (study group and control group). Placement of balanced buttress     absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two     groups were compared in this study.   "
17202|NCT03060369|"     This pilot study aims to examine the relationship between continuously measured CareGuide™     muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring     techniques during the care of subjects with suspected established (Cohort A) or emerging     (Cohort B) shock in the intensive care unit (ICU).   "
17203|NCT03060356|"     This is a pilot study to evaluate feasibility, safety, and preliminary evidence of efficacy     for intravenously administered, RNA electroporated autologous T cells expressing MET chimeric     antigen receptors with tandem TCRζ and 4-1BB (TCRζ /4-1BB) co-stimulatory domains (referred     to as RNA CART-cMET) in patients with advanced melanoma or breast carcinoma.   "
17204|NCT03060343|"     A single-center, open-label pilot study to determine the safety, tolerance and engraftment     potential of zeushield cytotoxic T lymphocytes in subjects with PD-L1+ positive non-small     cell lung cancer.   "
17205|NCT03060330|"     Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and     rectocoele are frequently identified in patients with ODS. Surgery is the only definite     treatment for those patients and is preferably performed minimally invasive. The most used     procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal     resection (STARR). However, high-level prospective studies on treatment strategies for ODS     currently are lacking and, thus, no consensus exist regarding the optimal treatment for     patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR     evaluating functional and anatomical results.   "
17206|NCT03060317|"     The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and     to assess its psychometric properties.   "
17207|NCT03060304|"     Cryopreservation of embryos created during fresh IVF cycles provides a less expensive and     time-intensive opportunity for pregnancy. Ideal endometrium thickness is the key point to     optimization FET cycle. Researches show that when endometrial thickness is less than 7mm,     pregnancy rate dropped significantly. Tamoxifen has been reported to be oestrogenic on the     lower genital tract. Several study on intrauterine insemination or ovulation induction     suggest that tamoxifen may be a promising alternative for patients with thin endometrium.     Based on this ,we want to evaluate the effects of tamoxifen on endometrial thickness and     pregnancy outcome in women who failed to develop an adequate endometrial thickness in     previous frozen embryo transfer cycle twice or even more times and willing to have another     attempt.   "
17208|NCT03060291|"     The purpose of this study is to develop and evaluate the effectiveness of a web-based version     of the Family Check-up (FCU). The FCU is a school-based family-centered intervention that has     been developed over the past 20 years and tested across the United States with diverse     populations. It focuses on enhancing parenting skills and family management in early     adolescence. The FCU has been shown to be highly effective at reducing adolescent problem     behavior, achievement problems, depression, and substance use over an extended period of     time.      In the original FCU, parents complete an assessment that evaluates family strengths and     challenges. They then receive feedback from a family consultant about how their data compare     to other families with children of the same age. As part of this feedback session, the     consultant helps motivate parents to make changes at home that will positively impact their     child and family overall. Parents and consultants decide together which child behaviors they     most want to see change. The consultant then works with parents to enhance relevant parenting     and family management skills.      Despite the demonstrated effectiveness of this intervention, few schools have the resources     and staffing to implement it without substantial support. It seems, then, that schools would     benefit from an online package that requires fewer school resources to implement. The     FCU-Online is designed to incorporate the successful components of the original FCU while     reducing the burden on schools. And, because it is accessed online, parents can utilize this     resource at a time and location convenient to them.      In this study, 300 families will be randomly assigned to one of three conditions: a web/     mobile-only version of the FCU, a web/mobile + coach version, or middle school as usual.     Research on mental health interventions delivered over the internet suggests that a coach or     in-person contact enhances outcomes. However, programs that require no coaching or     in-person contact are cheaper and easier for schools to deliver. Therefore, a web/     mobile-only version may allow more schools to deliver the intervention to a greater number of     families and children. Thus, investigators will test the relative effectiveness of a coach     version versus an online-only version at improving key parenting skills. It is predicted that     changes in parenting will lead to reductions in risk behavior, such as problem behavior at     school and substance use.   "
17209|NCT03060278|"     The proposed pilot study seeks to address the smoking cessation treatment needs of     underserved smokers with limited resources by evaluating the feasibility and preliminary     efficacy of a smartphone delivered automated video-assisted smoking treatment (AVAST). AVAST     will enable smoking cessation treatment content to be presented with voice/audio, images,     videos, and text in an interactive, structured format anytime and anywhere. Participants will     be recruited from the Urban Mission, a non-profit food and resource center that serves     approximately 20,000 people each year in the Oklahoma City metro area.   "
17210|NCT03060265|"     Protective analgesia in caesarean section using intravenous paracetamol: A prospective     randomised controlled trial. Cesarean section a common surgical procedure in women. The     parturients undergoing CS experience severe to moderate postoperative pain. Pain relief is     very important to the patient as it causes discomfort which affects hemodynamic     intraoperative and increases the risk of postoperative complications. Analgesia is crucial to     postoperative recovery.      Aims: To investigate the efficacy of combined administration of paracetamol, as protective     multimodal analgesia, and standard spinal anesthesia in the reduction of postoperative pain     following cesarean section.      Sixty adult Parturients undergoing CS will participate in a single-centered, randomized,     double-blinded, placebo-controlled trial divided into 2 groups 30 each. The intervention     group will receive 1 gr of intravenous paracetamol in 100 ml normal saline only 15 minutes     prior to spinal anesthesia induction. The control group will receive 100 ml normal saline IV     identical in size and shape and manner to the experimental group, 15 minutes prior to     induction of spinal anesthesia. We will measure postoperative Visual Analog Scale (VAS) pain     score, postoperative time to analgesia in PACU and number of postoperative analgesic doses     within 24 hours.   "
17214|NCT03060213|"     Subjective well-being refers to people's level of satisfaction with life as a whole and with     multiple dimensions within it. Interventions that promote subjective well-being are important     because there is evidence that physical health, mental health, substance use and health care     costs may be related to subjective well-being. This randomized controlled trial will evaluate     an online intervention, named Fun For Wellness (FFW), designed to promote well-being skills     and self-efficacy in six domains of life: interpersonal, community, occupational, physical,     psychological, and economic (I COPPE). The Usual Care (UC) control group will be wait-listed.     Five hundred (500) community-based adult patient participants will be enrolled. We     hypothesize that compared to the UC group, intervention group participants will show greater     improvement in their overall subjective well-being, domain-specific well-being,     health-related quality of life, and well-being self-efficacy.   "
17215|NCT03060200|"     The aim of this study is to test a newly developed app, firmly grounded in Cognitive     Behavioural Therapy (CBT) theory of depression, to determine primarily if this app is     clinically useful in decreasing moderate depressive symptoms when compared with an active     placebo. Additionally, we are interested in the app's potential to contribute to the     reduction of general negative affect, increasing positive affect, and boosting satisfaction     with life. Last, but not least, we aim to verify if the usage of the tested app can modify     depressogenic cognitions.   "
17216|NCT03060187|"     The purpose of this observational study is to evaluate the usefulness of Kansas University     airway exam score (KU score) in predicting difficulty of placement of a breathing tube into     the windpipe.   "
17228|NCT03060031|"     This experiment will explore the joint effects of social information, social support,     associative learning, and oxytocin on the development of placebo analgesia. The investigators     predict that socially transmitted placebo effects will be enhanced by nasal administration of     oxytocin, whereas associative learning effects on pain will not be altered by this     pharmacological manipulation   "
17229|NCT03060018|"     Partial blood oxygen and carbon dioxide pressures obtained in critical ill neonates by     transcutaneous sensors will be compared to respective values obtained by medically indicated     arterial and capillary blood gas analyses. The influence of blood withdrawal method, sensor     operational temperature and application time, presence of cyanotic heart malformations and/or     intra or extra cardiac right to left shunt, vasoactive drugs, elevated non-conjugated     bilirubin, and skin and soft tissue oedema, skin colour and perfusion conditions will be     elucidated as well as sensor`s safety. Study duration will be 48 hours with sensors applied     and additional 4 hours of further surveillance for thermal injury.   "
17217|NCT03060174|"     Postoperative cognitive dysfunction describes a condition where cognitive functions such as     attention, perception, concentration, learning, abstract thinking and problem solving are     impaired postoperatively. These changes can be resolved after weeks and months, but in some     cases may be permanent.      The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of     postoperative delirium.      A total of 638 consecutive patients will be enrolled in the study. Patients will be followed     up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and     compared to tests done before surgery. Postoperatively (from the day of operation until the     7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain;     cardiac; respiratory; renal and infectious complications will be recorded.      As possible influencing factors, the investigators will document diagnosed depression;     comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number     of operations/anaesthetics undergone after the initial operation.      Parameters that could trigger either depressive symptoms, neurocognitive dysfunction,     anxiety, fatigue or lack of concentration will be recorded. These include: anaemia,     hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular     filtration rate, cortisone therapy and adrenal cortical insufficiency.   "
17218|NCT03060161|"     Introduction: The epidemiological transition is one of the factors related to the increase in     the prevalence of chronic noncommunicable diseases (CNCD), such as cardiovascular diseases,     diabetes and cancer. Among the risks of risk to the development of CNCD are obesity, smoking,     alcoholism, sedentary lifestyle and inadequate eating habits, with the last two levels having     a high impact on gender and disease progression. Objectives: To promote healthy eating habits     and to combat physical inactivity through nutritional monitoring and regular physical     exercise, using a competition to stimulate adherence of the institution's employees. Methods:     The present project is in agreement with the longitudinal study with the work of evaluation     (anthropometric, body composition, laboratory and food consumption), in the eats of the times     (with base, three, six and nine months after the beginning of the project), except for the     laboratory evaluations, which is performed in three moments (baseline, three and nine     months). According to nutritional monitoring and individual guidance on regular physical     exercise practice over a period of 12 weeks. Weight reduction, body fat reduction, changes in     working methods and eating habits, and the relationship to routine physical activity after     the intervention period, and are retested after six months. Expected results: Reduction of     sedentary lifestyle, weight loss and body fat, improvement of eating habits, quality of life     without working environment and health condition of the participants.   "
17219|NCT03060148|"     Previous studies have shown that spinal cord stimulation (SCS) may improve cardiac output and     decrease the risk of ischemic ventricular arrhythmia in animal model and its safety profile     in human trial. The purposes of this study are to evaluate the feasibility, treatment     efficacy and safety of SCS in patients with severe symptomatic heart failure (HF).   "
17220|NCT03060135|"     There are a number of popular, freely available online interventions targeting hazardous     alcohol consumption. Unfortunately, most have limited or no published evidence regarding     their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The     current project proposes to evaluate its' efficacy employing a RCT, using The Check Your     Drinking intervention as an active comparator in the trial.      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential     participants identified as problem drinkers based on an initial survey will be invited to     complete another survey in 6 months time. Those who agree to be followed-up will be assigned     by chance to be asked versus not asked to access one of the interventions and then     recontacted 6 months later to ask about their drinking and their impressions of the online     intervention. The primary hypothesis to be tested is that participants receiving access to     any of the online interventions will report a greater level of reduction in number of drinks     in a typical week between the baseline survey and six-month follow-up as compared to     participants in the control condition.   "
17221|NCT03060122|"     This study will be aimed at assessing the feasibility of a dual-device treatment prior to a     rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on     improving outcomes and decreasing the risk for development of neuropathic pain. The     investigators will evaluate the clinical feasibility and effectiveness of incorporating the     Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk     factors associated with the development of neuropathic pain (i.e., pain, range of motion, and     skin temperature) as well as its impact on reduced pain medication.   "
17222|NCT03060109|"     The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild     head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify     that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test     platform.   "
17223|NCT03060096|"     Mental health issues in post-treatment adult cancer survivors are associated with multiple     adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose     of this study is to test a stepped-care approach tailored to symptom severity based on recent     American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety     and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue,     fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community     oncology settings and to examine intervention costs. The resultant intervention will have     great potential for widespread dissemination since it will be manualized, delivered by     telephone, and comprised of modules to allow customized treatments for individuals with     different cancer types.   "
17224|NCT03060083|"     The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior     research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes     experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the     most common method for smokers to reduce their nicotine intake is to reduce their number of     cigarettes per day (CPD). No research has compared reducing smokers' nicotine intake by     switching to VLNC cigarettes vs by reducing CPD with regard to decreasing dependence or     quitting; thus the investigators will examine the two strategies by randomizing smokers to 1)     switch to VLNC cigarettes or 2) reduce CPD. In addition, all smokers will use the nicotine     patch to help them reduce their nicotine intake.   "
17230|NCT03060005|"     The investigators hypothesize that the dry eye caused by SS may include the evaporative type,     resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are     associated with MGD.To test our hypothesis, we conducted a prospective clinical study in     patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were     matched for both age and gender and assessed for tear function and ocular surface signs and     symptoms.   "
17231|NCT03059992|"     This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy     and safety of SCY-078 in patients ≥ 18 years of age with a documented fungal disease that has     been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.   "
17232|NCT03059979|"     This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with     very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria     (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo.     Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is     at week 12, and patients will be followed up to one year after baseline   "
17233|NCT03059966|"     The purpose of this study was the evaluation of inflammatory and healing profile after root     coverage using of Enamel Matrix Derivative. 16 volunteers were selected and submitted to root     coverage surgery with subepithelial connective tissue graft, with and without enamel matrix     derivative. The patient screening was based in the following inclusion criteria: bilateral     recessions in maxillary anterior homologous teeth with aesthetical complaining ou     hypersensitivity, non-smokers, healthy and no use of any medication that compromises     periodontal health or healing. The split-mouth randomized model was followed in relation to     test and control sites. The following clinical parameters were analyzed at baseline and     6-month post-surgery: recession height, recession width, width of keratinized tissue, probing     depth, clinical attachment level, and gingival thickness. In addition to the surgical     analysis, evaluations of the following inflammatory markers were performed: IL-1β, IL -1RA,     IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF,     GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF. These     evaluations were performed at baseline, 7 and 14 days after surgery.   "
17248|NCT03059758|"     Most studies to date that have examined the factors underlying math achievement in children     have focused on basic numerical knowledge. Yet, math skills are clearly not limited to basic     numerical knowledge and recent behavioral studies suggest a relationship between math and     deductive reasoning skills. The goal of this study is to determine the neural mediators of     this relationship using functional magnetic resonance imaging. The investigators will ask     children from 8 to 14 to complete a standardized math achievement test, and measure their     brain activity while they process deductive arguments. The investigators will then correlate     brain activity during reasoning to individual math skills to identify the brain regions in     which activity during reasoning is modulated by math skill.   "
17249|NCT03059745|"     Comparing the use of surgical robotics during a Cholecystectomy, comparing different     platforms and approaches (multi port verses single port).   "
18148|NCT03047980|"     The purpose of this research study is to gain a preliminary understanding of the safety of     sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess the     utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber     syndrome.   "
17234|NCT03059953|"     For patients with moderate plaque psoriasis who are intolerable to, have a contraindication     to or have failed classical systemic treatments, the current commonly employed management     strategy encompasses treatment with biologic agents. The direct and indirect costs of     biologic treatment, accruing, among others, from the high drug acquisition and administration     costs, the required baseline safety screening and subsequent routine monitoring as well as     the potential loss of patients' working hours constitute a significant financial burden on     the public healthcare system. In light of the above evidence, it appears that in routine care     apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by     providing a promising treatment option to be employed prior to biologics, which has     demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles,     and has a limited manageable safety profile, while being more convenient and cost-effective     than biologics.      In view of the scarcity of real-world evidence regarding the impact of apremilast on the     patients' health-related quality of life (HRQoL) and extent and severity of the disease, and     under the consideration that the moderate psoriasis patient {defined as [10<body surface area     (BSA)<20 or 10<psoriasis area severity index (PASI)<20] and 10<dermatology quality of life     index (DLQI)<20}, naïve to biologic treatment was likely underrepresented in the pivotal     ESTEEM trials since approximately 30% of the enrolled patients had been previously treated     with biologic therapy, 28-30% had a baseline PASI score >20, and 48-52% had a BSA >20%, this     study represents an attempt to examine the impact of apremilast in routine clinical practice     settings in Greece on the patient with moderate plaque psoriasis when this therapeutic     strategy precedes biologics in the treatment algorithm.      Specifically, the present study aims to generate novel real-world evidence on the effect of     apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in     terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate,     and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus,     while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the     routine clinical practice of Greece.   "
17235|NCT03059940|"     The goal of this clinical research study is to offer lung cancer screenings to smokers who     want to change their smoking behaviors. All eligible participants will receive smoking     cessation counseling and may be offered at least one form of smoking cessation drug.     Different forms of counseling (the delivery of counseling and access to counseling) will be     compared.   "
17236|NCT03059927|"     The purpose of this study is to compare three prosthesis designs to compare three prosthesis     designs for total knee arthroplasty and determine the best option for patients in need of a     knee replacement.   "
17237|NCT03059914|"     The purpose of this investigator-initiated study is to compare new bone formation through     histomorphometric analysis following maxillary sinus augmentation using two different bone     graft materials. A total of twenty, sinus augmentation via a lateral approach will be     performed for subjects requiring sinus augmentation for implant placement and randomly     divided into 2 groups. These subjects will receive one of two different bone graft materials:     1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss     (Group B). At the time of implant placement (eight months after the sinus augmentation     procedure), two bone biopsies will be collected from augmented site for the histomorphometric     analysis. The percentage of vital bone will be measured and analyzed statistically, also the     following will be measured: percentage of non-vital bone, percentage of non-bone material     (xenograft), and the percentage of connective tissue.   "
17291|NCT03059199|"     The purpose of this research is to implement and evaluate the feasibility of the HAT- TRICK     Program, a gender- sensitive intervention program targeting physical activity, healthy eating     and connectedness in men living in the Okanagan Region, BC.   "
17238|NCT03059901|"     Despite numerous interventions designed to increase physical activity, few are specifically     tailored to Latinas, a population where higher rates of obesity, diabetes, and other chronic     diseases are present. This proposed smartphone app will use location-based services to     connect Latinas with one another in order to improve walking habits by increasing social     support and decreasing perceived barriers, both of which are known to play a role in physical     activity behaviors. In this Phase I research, surveys of potential end-users will determine     interest in the app and focus groups will help shape a prototype of the app, which will be     developed and tested to determine feasibility and functionality for a randomized Phase II     intervention.   "
17239|NCT03059888|"     This pilot research study is being done to see if the drug abatacept (Orencia ®) will be     helpful in treating patients with myasthenia gravis (MG) who do not respond satisfactorily to     other drugs that are used to suppress the immune system. Abatacept has been successful in     treating experimental MG in laboratory animals, and this study is to determine its     effectiveness in patients with MG.   "
17240|NCT03059875|"     The risk of diagnosis of cancer increases with age, especially breast cancer in elderly     women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities,     disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a     multidimensional approach to determine geriatric profile, in helping the therapeutic     strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric     filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten     questions includes geriatric domains such as functional status, nutrition, mood, cognitive     abilities and comorbidities. In elderly patients with breast cancer considered as fit     (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and     < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥     4 underwent CGA if palliative care is considered.      Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before     or after surgery.      The aims of this study are to assess the outcomes regarding the time of CGA, in elderly     female patients with breast cancer management, and to define the optimal place of CGA in care     pathway.   "
17241|NCT03059862|"     This study evaluates the role of dietary L-tryptophan, an essential amino acid, in the     activation of a specific cellular component: the aryl hydrocarbon receptor.   "
17242|NCT03059849|"     To examine whether a temporary three month increase in adalimumab dosing will prevent relapse     in patients with inflammatory bowel disease in clinical remission who have elevated     calprotectin.   "
17243|NCT03059836|"     This study will examine the influence of n3 PUFA supplementation on the rate of muscle     atrophy in women undergoing 2 weeks of unilateral limb immobilization. Assessments in     skeletal muscle strength and skeletal muscle volume will also me made before, after and in     recovery from immobilization.   "
17244|NCT03059823|"     The primary goal of this Phase 1 study is to characterize the safety and tolerability of     MGA012 and establish the maximum tolerated dose (MTD) of MGA012 administered on either every     two week or every four schedules of administration among patients with solid tumors.     Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGA012 will also be     assessed.   "
17245|NCT03059797|"     To compare the effects and safety of Anlotinib with placebo in patients with small cell lung     cancer(SCLC).   "
18306|NCT03045926|"     The main purpose of this study is to assess the concentration of elemental impurities in     blood and urine after chronic administration of Smecta® in subjects with chronic functional     diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote     composition will be investigated.   "
17250|NCT03059732|"     The differences in patient's clinicopathological characteristic between high and low     prevalence of gastric cancer region should be further examined to elucidate factors that     associate with poor survival rate of patients with gastric cancer. Therefore, this study     aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors     associated with different outcome in Thailand and Japan to find a clue to improve patients'     survival in low prevalence country such as Thailand.      This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial     Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan.     Eligible cases were selected by using standardized search protocols: formal computer searches     of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between     2010 and 2014.Two physicians, who were informed the definition of each variable, individually     reviewed chart of patients.   "
17251|NCT03059719|"     This is a randomized, opened, positive drug-controlled (Exenatide, Byetta), sequential     parallel group, multiple dose study to evaluate the safety, tolerability, pharmacokinetics     and pharmacodynamics of twelve once-weekly subcutaneous doses of PB-119 to subjects with type     2 diabetes mellitus (T2DM).   "
17252|NCT03059706|"     This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to     treat pain and the safety and efficacy on subject's activity and quality of life following     arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be     randomized and sequentially assigned to RegenoGel-OSP™ or placebo treatment on a 1:1 basis.   "
17253|NCT03059693|"     Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance     of epidermal-barrier function that results in intensely pruritic subacute and chronic     eczematous plaques. As the most common cause of chronic inflammatory skin diseases, AD is a     major cause of morbidity and suffering, affecting upto 30% of children, and increasing in     prevalence throughout the world. It is estimated that the direct cost of AD in the US alone     ranged from $0.9 billion to $3.8 billion every year. The current therapy of AD is reactive,     where the flares are treated through symptomatic management with topical corticosteroids and     calcineurin inhibitors. Given that these medications have long-term side-effects, and given     the chronically relapsing immunopathogenic nature of AD, there is an imperative need for     safer anti-inflammatory medications. Haus Bioceuticals (Haus) has developed a topical     treatment for eczema/atopic dermatitis (AD) denoted HAT1, and have demonstrated that HAT1 is     safe and profoundly effective in the treatment of AD, controlling signs and symptoms in 85%     of patients with AD. This study is aimed to further evaluate the potential of developing HAT1     as an integral part of AD therapy.   "
17254|NCT03059680|"     This study evaluates the safety and physiologic effects of increasing dietary potassium     intake in individuals with heart failure.   "
17255|NCT03059667|"     Chemotherapy still constitutes the backbone of small-cell lung cancer (SCLC) therapy,     particularly in the extensive disease (ED) stage (ED-SCLC). Despite the fact that a     substantial complete response rate could be achieved in SCLC patients receiving etoposide -     cisplatin doublet, cure remains the exception. Overall survival in patients receiving this     combination is 10 months and progression free survival 6.3 months. At time of progression two     options are hitherto accepted: reinduction of carboplatin - etoposide doublet or, for     patients unfit for reinduction, topotecan single-drug regimen. However, in both clinical     cases, median survival hardly achieves 33 weeks. Consistent data using anti - PDL1     (Programmed death-ligand 1) or anti PD1 (programmed cell death 1) antibodies suggest that     they are active as single drug regimens in many malignant diseases. Taking into account the     rich tumor infiltrating lymphocyte in pathological specimens of SCLC, we can hypothesize that     experimental use of ATEZOLIZUMAB (MPDL3280A) in patients is ethical pending that it     demonstrates activity in the second line setting.   "
17256|NCT03059654|"     To evaluate the usefulness of ultrasound-guided percutaneous dilatation tracheostomy PCT in     obese patients.   "
17257|NCT03059641|"     To evaluate the concordance of sensitizing mutations detected between paired plasma and     tissue samples; the correlation between the clonal status of sensitizing mutations and     targeted therapy response; and the prognostic impact of the relative abundance of sensitizing     / resistance mutations.   "
17258|NCT03059628|"     BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency     Department) for acute intoxication to take actions to prevent further alcohol-related issues.     The present project aims at underpinning this intervention by actively involving patients in     the monitoring of their alcohol-related risk following discharge. While several web-based     preventive interventions towards alcohol already exist, the repeated delivering of PNF     (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel     approach to reduce alcohol-related harms. Investigators propose to test the effect of a     mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol     intoxication. The mobile PNF will be additionally delivered once a month in the 6-months     period after discharge, and once every two months in the following 6-month period, via a     smartphone application connected to a central server. The study will include 18-26 years old     adults, as this population includes most active students and is often lost to follow-up after     ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most     of alcohol-related ED visits in this population.   "
17259|NCT03059615|"     This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated     with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles).      Evaluation will include safety procedures, blood level of study drug in certain time points,     immune system response and tests checking the mechanism of the drug action.   "
17260|NCT03059602|"     The purpose of this study is to describe the biopsychosocial impact of caregivers in patients     undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar     spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability     to provide care following surgery on a loved one.   "
17261|NCT03059589|"     The purpose of this patient registry is to demonstrate safety and efficacy of food oral     immunotherapy in food allergic patients. Factors that lead to adverse reactions will be     identified. The frequency of rescue epinephrine use will be recorded.   "
18307|NCT03045913|"     This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring     coronary revascularization with Drug Eluting Stents (DES).   "
17262|NCT03059576|"     The purpose of this investigation is to assess the role of the genetic and environmental     factor on circadian system, in free living conditions by the use of a female twin population.     With the results from this study, the investigators expect to advance in the understanding of     the role of the endogenicity of the circadian system variables such as temperature, activity,     sleep and timing of food intake as the main cause of the coincidence of the rhythms. However,     the investigators expected that some parameters are still dependent on environment to a     relevant extent and, hence, amenable to change through external interventions.   "
17263|NCT03059563|"     While deficits in dopamine D2-type receptor availability have been linked to substance use     disorders, higher availability associates with better behavioral treatment outcomes for     stimulant dependence and resilience to addiction. Varenicline has been shown to upregulate     D2-type receptors in drug-naive rats, and could be a useful therapeutic approach for the     treatment of addictive disorders in humans.      The purpose of the study is to assess the relationship between varenicline, dopamine     signaling (specifically, D2-type receptor availability), functional connectivity within     corticostriatal circuitry, genetic markers associated with smoking and methamphetamine abuse,     and measures of cognitive performance.      The investigators hypothesize that varenicline but not placebo will upregulate (increase)     striatal dopamine D2-type receptor availability and improve cognition, and that the change in     availability will correlate with the change in cognition. The investigators also hypothesize     that varenicline but not placebo treatment will repair dysregulated connectivity between the     striatum and prefrontal cortex observed in methamphetamine users, and will correlate with the     change in cognition.      The study design consists of two positron emission tomography (PET) and functional magnetic     resonance imaging (fMRI) scans to measure dopamine D2-type receptor availability and     functional connectivity between the prefrontal cortex and striatum, two cognitive testing     sessions including a battery of tests assessing working memory, declarative memory, sustained     attention, inhibitory control, and reward-based decision making. Following eligibility     screening, thirty six methamphetamine users will be enrolled and tested/scanned once prior to     initiation of varenicline or placebo treatment and then again after completion of treatment.   "
17264|NCT03059550|"     Because prevalence of glucose metabolism disorders is high in patients with coronary disease,     the Oral Glucose Tolerance Test (OGTT) is recommended in all patients without diabetes after     an acute coronary syndrome (ACS). However, there are some concerns about its performance in     clinical practice. The aim of our study was to evaluate, after an acute coronary syndrome     (ACS), the feasibility and efficacy of the OGTT in a cardiac rehabilitation (CR) center in     comparison with its real application in the whole French population.   "
17266|NCT03059524|"     The objectives are to:        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the          plasma of patients with and without multiple organ failure.        2. investigate the dysregulation of circulating miRNA panel and their prognostic and          predictive values in clinical outcomes in identifying patients at high risk for          mortality and multiple organ failure.      This trial involves peripheral blood sampling from subjects at their earliest presentation     and remaining stays in the hospitalization in the emergency department. The investigators     will develop panels of miRNAs that are specific indicator of early onset of major organ     failures, and correlate clinical outcomes with these miRNAs.   "
17267|NCT03059511|"     To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal     administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and     safety will be evaluated with summary of Adverse Events.      Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications:     septical work up.      Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known     kidney or liver disease, known chronic illness.   "
17268|NCT03059498|"     The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar     fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma     levels for patients undergoing PECS I/II blocks will be less than the levels reported to     cause early neurotoxicity of [2.2 (0.9) micrograms/ml]6 in patients receiving intravenous     bupivacaine infusions.   "
17269|NCT03059485|"     This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine     (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML).      The interventions involved in this study are:        -  Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)        -  Durvalumab   "
17270|NCT03059472|"     Strong Hearts for New York is a research study which aims to reduce cardiovascular disease     (CVD), improve quality of life, and reduce CVD related health care costs in rural     communities. Our aim is to better understand how changes in lifestyle can affect the health     of rural women and others in their communities.   "
17281|NCT03059329|"     The objective of this study is to identify the following in adult epilepsy participants with     partial-onset seizures (with or without secondary generalized seizures) or primary     generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:        1. unknown adverse drug reactions (ADRs);        2. occurrence of ADRs;        3. factors that are likely to affect safety and efficacy;        4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse          events, and falls as priority investigation items;        5. occurrence of psychiatric adverse events as priority investigation items (eg,          aggression).   "
17282|NCT03059316|"     Controlled hypotension has been used as a mean of reducing intraoperative blood loss and     better visualization of the surgical field in nasal surgeries. Perfusion index has been     considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and     serum lactate for central perfusion. Many medications were used to induce hypotension. In     this study we will compare the effects of tridil and labetalol on the perfusion.   "
18351|NCT03045341|"     This study will test the effectiveness and relative efficacy of behavioral and pharmacologic     treatments, alone and in combination, for the treatment of binge eating disorder (BED) in     patients with obesity. This is an acute treatment comparing behavioral weight loss alone or     in combination with naltrexone/bupropion medication.   "
17271|NCT03059459|"     Several studies have demonstrated the association between atmospheric pollution and chronic     respiratory diseases. The magnitude of this association and its dependence of local factors     are still unknown in Argentina, particularly for obstructive lung diseases like asthma and     chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the     effect of atmospheric pollution due to particulate matter (PM) on asthma and COPD     exacerbations in adults. A prospective cohort study will be carried out in patients attending     the pulmonary service of a public hospital located in San Nicolas, Buenos Aires province,     Argentina. Patients will be followed for 12 months after recruitment. The outcome variables     will be the frequency of hospitalizations or emergency department consults for asthma or COPD     exacerbations and related conditions, and the impact of COPD on a person's life as measured     by the COPD assessment test (CAT) questionnaire. The exposure will be the pollution level in     the particular address, measuring PM10 concentrations with portable equipment. Other     variables as air temperature, humidity, and individual patient risk factors will be     considered as potential confounders or effect modifiers. The associations will be estimated     through regression models, i.e. logistic and Poisson regressions and recurrent event survival     analysis. The results of this study should provide elements to estimate the risk of chronic     respiratory diseases associated with atmospheric pollution, and to evaluate strategies for     risk assessment in the local community.   "
17272|NCT03059446|"     This rollover study will provide open-label treatment with cenicriviroc and will assess the     long-term safety of continued treatment with cenicriviroc in participants who participated in     the CENTAUR study 652-2-203 [NCT02217475].   "
17273|NCT03059433|"     Advancement via Individual Determination (AVID) is a college preparatory program that     provides a unique opportunity to determine whether schools can reduce substance use by     re-grouping at-risk students with high-performing students, while providing additional     academic and emotional support. Operating in 4,837 K-12th grade schools worldwide and across     45 US states, this widely-disseminated program targets students from groups traditionally     underrepresented in higher education who are currently performing in the academic middle     (i.e., a 2.0-3.5 grade point average). AVID removes these students from typical classrooms     and exposes them to a peer network in which academic performance and positive social norms     are valued. In addition, by strengthening the student/teacher relationship, AVID expands     students' networks of supportive adults. For low-income minority students in the academic     middle, relatively small investments in prevention might significantly impact their academic     and health trajectories. AVID capitalizes on a moment when social networks are in flux—the     transition to high school—to shift these students' trajectories.      This study is a longitudinal, randomized pilot evaluation of AVID among low-income minority     adolescents entering high school, comparing academic performance and drug use, as well as     other risky behaviors, over 3 years. Although social networks are hypothesized to have a     strong influence on behavior, few studies have tried to re-wire networks to change behaviors.     This study will provide a clearer understanding of whether schools can intentionally shape     networks and whether these changes can reduce substance use. This study will also explore     important mechanistic questions about whether and how AVID changes peer networks and     relationships with teachers, whether those changes lead to improvements in academic and     behavioral outcomes and, if so, what the relative importance of peer versus adult network     changes are.   "
17274|NCT03059420|"     The purpose of this study is to identify genes associated with impaired development and     function of the cranial nerves and brainstem, which may result in misalignment of the eyes     (strabismus) and related conditions.   "
17275|NCT03059407|"     Young children with known or suspected heart disease frequently have difficulty cooperating     with a clinically ordered echocardiogram. Current distraction techniques vary in efficacy.     There have been no studies examining the use of animal assisted therapy to improve     echocardiogram quality and completeness, as well as the patient/parent experience.      Hypotheses:        1. The presence and interaction of therapy dogs with young children undergoing          echocardiography in a clinical setting will result in more complete and higher quality          echocardiograms compared to standard distraction techniques.        2. Parents will report higher visit satisfaction scores and greater exam comfort for their          children for echocardiograms performed with the aid of canine assisted therapy compared          to use of standard distraction techniques.      Study Activities and Population Group:      Pilot Phase: Introduction of trained therapy dogs (approved by the Pets at Duke Therapy     Program) for 10 echocardiograms to observe canine-patient interactions and determine best     practices for inclusion of dog/handler team into the echocardiogram protocol.      Study Phase: 150 subjects ages will be selected from all children ages 1 to 5 years     presenting for clinically ordered echocardiograms during the study time period. Subjects will     be assigned into one of three groups: 1) Canine assisted therapy only; 2) Canine assisted     therapy plus standard distraction techniques; and 3) Standard distraction techniques only.     Echocardiography reviewers will be blinded to subject study group and will assign quality and     completeness score based on validated criteria. Parental satisfaction will be assessed using     validated survey tools.      Data analysis and risk/safety issues:      All subjects will be assigned a random subject ID, with the only link to PHI stored in a Duke     Redcap database. Statistical testing will be performed with the assistance of Tracy Spears     (biostatistician in DCRI) who has assisted with development of testing tools. There are no     physical risks associated with the echocardiogram portion of the study, and very minimal     risks with the therapy dog portion of the study. Please see Pets at Duke policy included in     study documents. There is a potential loss of confidentiality, although the only link between     subject ID and PHI will be stored in a Duke Recap database.   "
17276|NCT03059394|"     The aim of the study is to evaluate the psychometric properties (content and construct     validity, reliability, measurements error, as well as possible floor and ceiling effects) of     both the assessments MMT8 and the myositis activity profile in patients with IM.   "
17277|NCT03059381|"     The objective of this study is to identify the following in adolescent epilepsy participants     with partial-onset seizures (with or without secondary generalized seizures) or primary     generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:        1. unknown adverse drug reactions (ADRs);        2. occurrence of ADRs;        3. factors that are likely to affect safety and efficacy;        4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse          events, and falls as priority investigation items;        5. occurrence of psychiatric adverse events as priority investigation items (eg,          aggression).   "
17278|NCT03059368|"     To construct a self-designed plate fixation device for posterior cruciate ligament     reconstruction, aim to verify its advantages on anatomical knee stability, so as to achieve     fracture healing and keep tension after posterior cruciate ligament reconstruction.   "
17279|NCT03059355|"     This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered     intravenously in patients to evaluate cytokine suppression in patients with chronic     inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37     patients in two phases (Pilot and Randomized).   "
17280|NCT03059342|"     Purpose: The aim of this study is to assess the short- and midterm evolution of self-care and     functional mobility after multilevel surgery in children and adolescents with spastic     diplegic cerebral palsy and to identify which factors could have an impact on these outcomes.      Methods: Thirty-four participants were included. All participants will be evaluated before     surgery, at 9 weeks, 6,12,18, 24, 36 and 60 months. Self-care was assessed with the Pediatric     Evaluation of Disability Inventory-NL (PEDI-NL). The Mobility Questionnaire47 (MobQues47) and     Functional Mobility Scale (FMS) were used to measure functional mobility. Interactions     between CP, personal and environmental characteristics and evolution in time were assessed.   "
17284|NCT03059290|"     this prospective in vivo randomized clinical is to evaluate the post operative pain     (incidence ,degree and duration) with multiple full rotation file (protaper next ®) and     single full rotation file (Neolix®) in treating maxillary and mandibular anterior and     premolar with chronic pulpitis .Together with our aim from this trial ; we are trying to     provide an evidence for the dentists in order to provide the best quality service with the     least expenses and thus gaining the patients' trust and saving time, money and effort.   "
17285|NCT03059277|"     The purpose of this study is to determine the efficacy of intravitreal aflibercept injections     administered in a treat and extend fashion in eyes that have persistent center involved     diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab     over 24 weeks.   "
17286|NCT03059264|"     Congenital Myotonic Dystrophy (CDM) is a multi-systemic, dominantly inherited disorder caused     by a trinucleotide repeat expansion (CTGn) in the DMPK gene. CDM occurs when the CTGn     increases between the adult myotonic dystrophy type-1 (DM1) parent and the child. Children     with CDM present at birth with respiratory insufficiency, talipes equinovarus, feeding     difficulties and hypotonia. There is a 30% mortality rate in the first year of life. As     children grow, they are at risk for intellectual impairment, autistic features,     gastrointestinal symptoms, and motor delay.      The investigators will enroll children with CDM between ages 0-15 with visits at baseline and     one year to evaluate appropriate physical functional outcomes, cognitive function and quality     of life over time. Functional outcome measures will be correlated with potential biomarkers     in the children. Completion of these specific aims will extend the understanding of disease     progression in CDM and will provide the requisite information for successful therapeutic     trials in children with DM.   "
17287|NCT03059251|"     This observational study aims to study the effectiveness and safety of Obinutuzumab in common     clinical practice settings in Argentina. The study population comprises all patients with     chronic lymphocytic leukemia (CLL) that have received the indication for treatment with     Obinutuzumab as per routine clinical practice.   "
17288|NCT03059238|"     This phase III, randomized, prospective clinical study, aiming to compare the analgesic     effects of celecoxib, parecoxib, and oxycodone in patients with inoperable hepatic carcinoma     undergoing TACE procedure in postoperative pain control.   "
17289|NCT03059225|"     The refinement of repetitive transcranial magnetic stimulation (rTMS) has highlighted its     merit in terms of learning programs as a treatment for aftereffect augmentation.     Nevertheless, the efficacy of synchronous rTMS protocol integrated with computer-integrated     speech training is not well understood. It is also not clear regarding the efficacy of     compound bi-hemispheric stimulation protocol. The aim of the study is to investigate language     response to these new strategies and to determine the longevity of the therapeutic outcome.     Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the     concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI     and DTI microstructural evolution provides insight into underlined mechanism operating the     language improvement.   "
17292|NCT03059186|"     The primary aim of the proposed research is to investigate the extent to which a one-week     online gratitude intervention can improve levels of wellbeing in individuals living with     Inflammatory Bowel Disease (IBD). A secondary aim was to investigate the extent to which     dispositional gratitude influences levels of coping and wellbeing and to what extent this     mediates the effect of the intervention. Participants with IBD will be randomized to either     treatment or control group. Participants will complete measures pre- and post- intervention,     and follow-up (eight weeks) measuring: gratitude (state and trait), illness severity, mood,     stress and coping.   "
17293|NCT03059173|"     The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to     Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double     blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the     Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation     induction by CC. Half of them will receive MYO + folic acid (FA) in addition to the CC, while     the other half will receive a placebo containing only FA in addition to the CC. The MYO     supplementation will be initiated at least one month before taking CC and will be continued     throughout this treatment until pregnancy or before switching to another type of treatment     for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.   "
17294|NCT03059160|"     This is a single-center, exploratory, open-label study in 10 girls diagnosed with Rett     Syndrome. The study will consist of the following 4 parts: Screening/Baseline run-in,     Titration/Dose-Setting, Treatment, and Washout/Follow-up.   "
17295|NCT03059147|"     2.1 Primary Objectives        1. To determine the maximum tolerated dose (MTD) or maximum recommended dose of SF1126 in          adult patients with advanced (unresectable or metastatic) HCC and Child-Pugh A or          Child-Pugh B7 cirrhosis.        2. To determine the recommended phase II dose of SF1126 in patients with advanced          (unresectable or metastatic) HCC and Child-Pugh A or Child-Pugh B7 cirrhosis.      2.2 Secondary Objectives        1. To describe the safety and tolerability of SF1126 in adult patients with underlying          liver disease by ongoing evaluation of adverse events.        2. To determine pharmacokinetics in HCC patients.        3. To assess the effect of SF1126 on progression-free survival and overall survival.      2.3 Endpoints      Primary Endpoint      The primary endpoint is the rate of dose limiting toxicities (DLTs) at within 56 days of     starting treatment, and the maximum tolerated dose or maximum recommended dose of SF1126.   "
17327|NCT03058731|"     This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients     whom underwent paraesophageal hernia repair between October 1, 2012 and May 31, 2015.     Patients whom are willing to participate in the study will be asked to return for a one time     follow up visit to reassess for hiatal hernia recurrence both symptomatically and     radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh     to other biologic meshes.   "
17296|NCT03059134|"     This clinical trial compared the therapeutic effects and adverse events (AEs) in overactive     bladder (OAB) patients receiving different combination of mirabegron and antimuscarinics.      Methods: This is a prospective randomized study. OAB patients received mirabegron 25 mg (M25)     daily for one month (1M) and then were randomized as group 1: to continue M25, group 2: to     mirabegron 50 mg, group 3: to shift to solifenacin 5 mg (S5) and group 4: to combine M25 and     S5 for further 2 months (totally 3 months, 3M). Efficacy and AEs were evaluated. At the end     of 3M, the preferred option for future treatment was investigated.   "
17297|NCT03059121|"     In this observational study, the investigators will examine the changes in body composition     in HIV-infected subjects before and after initiation of HIV treatment. The effects of     lifestyle factors on body composition changes after antiretroviral therapy (ART) are unknown,     and as such, investigators will use this prospective observational cohort to study     relationships between lifestyle factors, including diet, physical activity and illicit drug     use, with changes in body composition after ART. In addition, the effect of the body fat     changes will be correlated to changes in cardiometabolic indices such as endothelial function     and coronary calcium scoring.   "
17298|NCT03059108|"     The trial is designed as a consecutive enrollment prospective one-center study. A minimum of     30 patients will be included in the study. At implant installation, the implant will be     randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading,     4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be     collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months.     Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the     impressions are taken.   "
17299|NCT03059095|"     The study rationale is to analyze the extent to which adult U.S. or non U.S. veterans or     active duty military personnel who participate in the Yoga for Men (YfM) online Yoga and     meditation classes report changes in symptoms of psychological trauma, depression, anxiety,     stress, sleep quality, and pain. The serial measurement of symptom status over a 12-month     period will provide information on the trajectory of change in symptom status, as well as     insight into the extent to which this program may be an effective modality for veterans and     service members who are experiencing symptoms of psychological trauma, depression, anxiety,     stress, sleep quality, and pain. The purpose of this study is to evaluate whether the     existing YfM online program is helpful to study qualifying veterans with symptoms of PTSD and     related conditions.   "
17300|NCT03059082|"     Excessive alcohol consumption is common in patients admitted to the intensive care unit     (ICU). Among patients who survive an ICU admission, excessive alcohol consumption is     associated with a higher risk of being admitted the hospital. In this study, the     Investigators will compare an intervention designed to address excessive drinking in ICU     survivors to usual care. This intervention combines motivational interviewing (MI) and shared     decision making (SDM). MI and SDM share several core components including the development of     a therapeutic alliance and promotion of autonomy. MI can be employed in the context of     motivating a patient to change their drinking. Once this decision has been made, SDM can be     employed to help a patient decide amongst multiple reasonable treatment options. The     Investigators long-term goal is to test whether MI-SDM is better than usual care and whether     multiple sessions of MI-SDM are better than a single session. This pilot clinical trial will     demonstrate the feasibility of conducting a larger efficacy study to test these hypotheses.   "
17302|NCT03059056|"     Project PI (Principal Investigator): Dr Bassam Mahfouz Ayoub, Ph.D., Lecturer of     Pharmaceutical Chemistry, The British University in Egypt.      Study Design The proposed study will consider the pharmacokinetic evaluation of empagliflozin     after administration to Egyptian volunteers and the results will be compared with the other     reported ethnic populations. The FDA recognizes that standard methods of defining racial     subgroups are necessary to compare results across pharmacokinetic studies, and to assess     potential subgroup differences. The design of the study is open labeled, randomized, one     treatment, one period, single dose pharmacokinetic study.   "
17303|NCT03059043|"     This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable     Collamer Lens(ICL) implantation to treat high myopia. Subjects were randomly assigned either     to the new method group or to the control group which uses the standard method for     implantation. The post-operative data are collected for analysis.   "
17304|NCT03059030|"     Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of     thrombocytopenia.   "
17305|NCT03059017|"     The relative bioavailability of different salbutamol sulphate inhaler formulations will be     studied in healthy male subjects according to the ethical regulations of World Medical     Association Declaration of Helsinki (1996) after the approval of the ethical committee,     Faculty of Pharmacy, The British University in Egypt.   "
17306|NCT03059004|"     Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United     States. Many people who have knee arthritis also experience painful meniscal tears. There are     a number of different treatments that can be used to manage meniscal tears in the presence of     knee arthritis. Treatments include surgically removing the damaged part of the meniscus;     strengthening exercises to improve pain and function; manual therapy including massage and     mobilization; acupuncture; and others. The combination of surgery and exercise therapy was     long thought to be the best treatment. However, recent studies have shown that surgery     followed by physical therapy is no more effective than physical therapy by itself.      While physical therapy alone has been shown to result in similar pain relief as arthroscopic     surgery, researchers have not yet done studies to determine what type of physical therapy is     best for people with knee arthritis and meniscal tears. In the TeMPO Trial, we will be     comparing 4 different, non-operative physical therapy regimens in order to gain a better     understanding of how physical therapy works and what regimen will best reduce pain and     improve function in persons with meniscal tear and osteoarthritis. The four arms in this     randomized trial will contain different combinations of therapeutic treatments including     in-clinic therapist-supervised exercise, in-clinic topical therapies, and exercises to be     completed at home. Subjects in three of the arms will also receive motivational SMS (text)     messages intended to improve adherence to the home exercise regimen.      TeMPO is designed as a randomized controlled trial. Participants will be assigned randomly to     one of the four arms. All arms include therapies that have been previously shown to work in     clinical settings. One arm also contains some placebo treatments. The placebo treatments will     help us to understand what aspects of physical therapy actually make people feel better.      Our hypothesis is that subjects in the arm that includes in-clinic physical therapy and a     home exercise regimen will experience more pain relief than subjects in each of the other     arms. Also, we expect that subjects in the arm that receives the home exercise regimen and     SMS messages will experience more pain relief than subjects in the arm that receives home     exercise without the SMS messages.   "
17328|NCT03058718|"     To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of     bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.   "
17307|NCT03058991|"     The purpose of the current proposal is to investigate the extent to which interventions     designed to improve cognitive (working memory) and emotional (distress tolerance) regulatory     processes enhance the effectiveness of standard no-smoking informational interventions.     Emotional and cognitive dysregulation increases the likelihood of smoking and makes it     particularly challenging to benefit from standard interventions. Working memory and     associated deficits make it more difficult for individuals to utilize information from     interventions, make judicious decisions regarding the cost and benefits of smoking, and to     resist targeted advertising. In addition, disruptions in emotion regulatory capacities     increase the probability of using cigarettes as a coping mechanism to self-regulate negative     affect and stress. Individuals with affective disturbances smoke at higher rates and have     more difficulties quitting, and are more likely to smoke as a way to reduce negative affect.     The goal of the current project is to generate new insights and new approaches to smoking     prevention among low-SES youth by investigating (1) the influence of known SES-related     deficits in working memory and affect regulation on proximal measures of smoking risk, and     (2) the potential for targeted interventions to reverse these risks. Specifically, the     investigators examine the influence of working memory training and distress tolerance     (mindfulness) interventions on cognitive/affective targets placing individuals at risk for     smoking initiation and maintenance.      The specific aims of this study are therefore to investigate:        1. The feasibility and acceptability of school- and community-based brief interventions          targeting working memory and distress tolerance in a diverse sample of low SES          adolescents.        2. The effects of working memory and distress tolerance interventions, relative to a          standard informational intervention alone, on specific cognitive-affective targets—delay          discounting and distress tolerance--relevant to cigarette smoking initiation and          maintenance.        3. The impact of cognitive /affective target activation on proximal measures of smoking          risk/behavior and related health outcomes following intervention.   "
17308|NCT03058978|"     The study will evaluate how the ovaries may be functioning while using the the     Implanon®/Nexplanon® during the three years beyond the FDA approved duration. Ovarian     function will be assessed with weekly serum progesterone levels. Participants will undergo     weekly venipuncture for a total of four draws. Participants will be followed for 30 days.   "
17309|NCT03058965|"     The overall goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET     radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy     (PSP), and healthy volunteers (HV).   "
17310|NCT03058952|"     This study is a randomized clinical trial measuring outcomes up to 6-months     post-intervention. The objective of this study is to evaluate outcomes of two different group     interventions for Veterans with Chronic Multisymptom Illness (CMI). The interventions to be     compared are Mindfulness-Based Stress Reduction and an adapted version of the Chronic Disease     Self-Management Program (aCDSMP) for Veterans experiencing symptoms of Chronic Multi-Symptom     Illness (CMI) - musculoskeletal pain, fatigue, and cognitive failures - especially those who     were deployed to Gulf War I. Hypothesis One (re: Outcomes): Participants randomized to the     adapted Chronic Disease Self-Management Program (aCDSMP) will derive benefit for the primary     outcomes, but with smaller effects than the participants randomized to Mindfulness-Based     Stress Reduction (MBSR). The investigators hypothesize that Veterans randomized to MBSR will     report greater reductions in each of the three primary outcome measures (pain, fatigue, and     cognitive failures) at 6-month follow-up as compared to aCDSMP. Hypothesis Two (re:     Acceptability): MBSR will be an acceptable and satisfactory program for Veterans with CMI, as     measured by attendance rates, a self-report measure of satisfaction, and qualitative     interviews. The investigators hypothesize that Veterans with CMI randomized to MBSR will     report greater satisfaction with care than their peers randomized to aCDSMP.   "
17311|NCT03058939|"     This is a two-stage phase II study with a single arm design. It will be conducted in women     with breast cancer with stages IIA to IIIC (defined by AJCC 2009 classification) of all     histological subtypes. All patients will receive 16 doses of paclitaxel; three breast     ultrasound tests and tumor pathologic response evaluation will be used to assess the response     to treatment.   "
17351|NCT03058419|"     The main purpose of this study is to determine the potential inhibitory/inducing effects of     JNJ-54175446 after single and repeated dosing on the single-dose pharmacokinetics (PK) of a     cocktail, containing selective probes of cytochrome P450 (CYP) enzymes (CYP3A4/A5, CYP2C9,     CYP1A2, CYP2D6, CYP2B6, and CYP2C19) in healthy adult subjects.   "
17312|NCT03058926|"     The data management systems, auditing, and monitoring effort are supported by the MD Anderson     Cancer Center Clinical Research Support Center (CRSC). The The Coordination and Data     Management Center (CDMC) will provide high quality, efficient and consistent leadership and     services in all aspects of data quality and assurance; data harmonization and management;     while providing assistance to the projects in disseminating and interpreting those data. The     CDMC PI will provide statistical (study design, analysis plans, data analysis, and     interpretation), data management, and data monitoring/auditing (data quality assurance and     harmonization) expertise for the proposed projects. The Cancer Center will have access to     identifiable data from studies; analysis of this data will not be conducted under this     protocol. Any future analysis conducted on data or specimens as part of CPDPC protocols will     be conducted under a separate IRB approved data or lab protocol.      The CDMC will leverage existing support, infrastructure, and resources from the Data     Management and Coordinating Center for the Global Cancer Early Detection and the clinical     expertise of the Division of Pathology/Lab Medicine at MDACC.   "
17313|NCT03058913|"     This registry is created under the sponsorship of the Outpatient Endovascular and     Interventional Society (OEIS) to monitor the clinical course and treatment outcomes of     patients undergoing office-based endovascular procedures.   "
17314|NCT03058900|"     An abnormal intestinal microbiota may be the mediator of the common inflammatory pathways     seen in psoriatic arthritis. This study will explore clinical aspects associated with     modifying the intestinal microbiota by infusing fecal donor microbiota into the small     intestine of psoriatic arthritis patients with a minimum of three swollen joints despite at     least three months of methotrexate treatment.   "
17315|NCT03058887|"     Systemic sclerosis (SSc) is a multisystem connective tissue disease characterised by vascular     abnormalities and fibrosis, including those of the skin and can be categorised as either     Limited cutaneous scleroderma or Diffuse cutaneous scleroderma. It is estimated that more     than 90% of patients with SSc experience Raynaud's phenomenon (RP) at regular intervals     during the course of their disease. Approximately 50% of patients with SSc develop severe     digital ischaemia and/or ulceration which seems to be painful, difficult to heal, susceptible     to infections and heavily influences quality of life and increases SSc-related disability.      Medical treatment is commonly used as an effective first line approach in the NHS policy when     uncontrolled RP attacks emerge. However, considering the short-term side effects (oedema,     headaches, heart palpitations, dizziness and constipation) but also the long-term side     effects of nifedipine (heart dysfunction and increased cardiovascular risk) as well as the     financial cost of this approach, alternative approaches with less side effects and less cost     implications are warranted.      An alternative approach would be to implement a programme of therapeutic exercise that would     be suitable for this patient group. To the investigators knowledge the efficacy of exercise     on microcirculation in RP has not been previously examined. In this regard, high intensity     interval training (HIIT) has come to prominence over the last years for its effectiveness in     inducing greater improvements in vascular function than moderate intensity continuous     training. Due to the variation in HIIT protocols evidence is limited to support which     protocol is the most effective in SSc patients. Moreover, it should be noted that the chief     aim of the research project is to encourage long-term adherence to physical activity and     rehabilitation programmes in these patients which might be beneficial for the vascular     function. A short HIIT protocol (30seconds/passive recovery) may elicit more favourable     patient reported satisfaction /enjoyment levels compared to other longer exercise duration     protocols. A short HIIT protocol (30seconds/passive recovery) has demonstrated to be well     tolerated, preferred protocol with a low perception of effort, patient comfort and with a     longer time spent at high percentage of V̇O2peak than a longer HIIT protocol with active     recovery phases in chronic heart failure patients. More recent evidence supports this notion;     when enjoyment levels in an overweight/obese cohort were examined after a short HIIT     protocol.      Although it is known that HIIT is capable to improve vascular function and potentially the     microcirculatory parameters, evidence is scarce regarding the mode of exercise that will be     more effective on digital microcirculation where the RP attacks are present in SSc patients.     Assumptions could be made that utilising an upper-body exercise would potentially be more     beneficial for the digital microcirculation rather than lower-body exercise where the working     muscles promote the blood flow in the lower limbs. Hence, the differential effects that may     occur by the upper- and lower-limb exercise on the digital microcirculation in SSc patients     should be examined.      Resistance training (RT) alone has shown significant improvements in the function of the     vasculature; moreover, a combination of aerobic and RT have shown both in the past and     recently important enhances in the vascular function and microcirculation. However, the     limited number of studies have investigated the effects of RT on vasculature bespeaks a lack     of concrete evidence. Moreover, to the investigators knowledge the effects of combined     exercise (RT and aerobic exercise) utilising a HIIT protocol and RT on microcirculation has     yet to be examined.      Aims:      The primary aim of the present study is to examine the feasibility of exercise in patients     with Systemic Sclerosis experiencing Raynaud's Phenomenon.   "
17316|NCT03058874|"     The most common co-morbidity accompanying Chronic Kidney Disease (CKD) is hypertension, which     appears in approximately 80% of all patients with renal dysfunction, whereas its prevalence     in general population is remarkably lower appearing in approximately 30% of adults.Defining     hypertension in ESRD patients under maintenance dialysis is a challenging procedure.     Ambulatory blood pressure monitoring (ABPM) is considered the gold standard for the     diagnosis of hypertension in hemodialysis patients over the last years. The major     pathophysiologic mechanism underlying hypertension development in patients with ESRD under     hemodialysis is water and sodium overload.      Identifying an accurate and objective method of dry weight evaluation has been a matter of     intensive nephrology research for more than two decades. Assessment of the water balance in     hemodialysis patients on the basis of common clinical criteria (e.g. leg or face swelling or     signs of lung congestion) is a subjective method with limited reliability, despite its     widespread use. Recently, a novel technique has been developed to quantify water excess by     conducting an ultrasound lung scan. Pilot studies have shown significant changes in lung     water in hemodialysis patients according to body weight changes during interdialytic days and     dialysis sessions. Moreover, results from previous studies indicate significant benefits from     dry weight probing with regards to blood pressure (BP).      The clinical application of a lung-ultrasound-based volume control strategy in hemodialysis     patients is currently being tested by the randomized study entitled Lung water by ultrasound     guided treatment to prevent death and cardiovascular complications in high risk end stage     renal disease patients with cardiomyopathy (The LUST Study). This clinical trial aims at     evaluating whether the use of the number of US-B lines could be used as a biomarker to guide     a per-protocol intensification of ultrafiltration (UF) in order to reduce volume overload,     improve cardiac function and prolong survival.      Cardiovascular disease in patients with CKD is attributed to a spectrum of structural and     functional alterations of the large and the small branches of the arterial tree. The most     important process in patients with advanced CKD is that of arteriosclerosis, which is     developed in parallel to atherosclerosis and is typically associated with impaired cushioning     function of the aorta and the large conduit arteries. Accelerated arterial stiffening is     involved in the development of isolated systolic hypertension, left ventricular hypertrophy     (LVH) and congestive heart failure (CHF), which predispose to arrhythmias and sudden cardiac     death. In the context of the phenomenon of aortic-to-brachial BP amplification, systolic BP     (SBP) and pulse pressure (PP) conventionally measured at the level of brachial artery are     higher than the relevant pressures in the ascending aorta. Due to extreme elevation of     arterial stiffness, BP amplification is disturbed in patients with ESRD. Prospective cohort     studies have demonstrated that elevated central PP, wave reflections and arterial stiffness,     as well as, reduced PP amplification represent strong and independent predictors of all-cause     and cardiovascular mortality in hemodialysis patients. On this basis, estimation of central     BP indices appears as an important tool towards optimisation of cardiovascular risk     stratification in ESRD as well as in other diseased populations.      Until recently, available devices for ABPM evaluated BP levels only at the level of brachial     artery. The newly developed Mobil-O-Graph NG (IEM, Stolberg, Germany) provides the ability to     monitor central aortic pressure and indices of vascular resistance, such as wave reflections     (augmentation index, AIx) and arterial stiffness (pulse wave velocity, PWV).This device has     recently been validated in hemodialysis patients and showed comparable performance with the     widely used tonometric SphygmoCor device (ArtCor, Sydney, Australia). Accumulated evidence     over central BP and PWV in hemodialysis patients derives mostly from studies that included     only static pre-dialysis and post-dialysis measurements. However, variations of BP levels     during intra- and interdialytic intervals combined with the superiority of aortic BP     measurements, as analysed above, indicate that ambulatory monitoring of central BP is the     best available method.      This study aims for the first time to evaluate the outcome of a treatment strategy for dry     weight probing, based on volume overload quantification with lung ultrasound, on 24-hour     aortic systolic BP and arterial stiffness in hemodialysis hypertensive patients.      This is a Lust Sub-Study. Additional information can be found at: NCT02310061.   "
17317|NCT03058861|"     The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting     intervention in pediatric primary care.   "
17318|NCT03058848|"     To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new     Phe free protein substitute for the dietary management of PKU in infants from birth.   "
17319|NCT03058835|"     The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP     procurement through the established access procedures, and adherence to Truvada PrEP among US     women at risk for HIV acquisition.   "
17320|NCT03058822|"     A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to     drug in vial   "
17321|NCT03058809|"     This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a     meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon     or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the     change in circulating tumor cells as determined before and after treatment.   "
17322|NCT03058796|"     Determine if adding a video game component to an electrical stimulation therapy improves hand     function in stroke patients   "
17330|NCT03058692|"     This is a Phase II randomized, double-blind, placebo-controlled trial in 240 males and     non-pregnant females, 18 to 45 years old, inclusive, who are in good health and meet all     eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity,     and immunogenicity of two priming doses of M-001 followed by boosting with two doses of     MF59-adjuvanted or non-adjuvanted monovalent influenza A/H7N9 IIV. The monovalent influenza     A/H7N9 IIV was derived from the HA of the influenza A/Shanghai/2/2013 (H7N9) virus. Primary     objectives: To assess the safety and reactogenicity of M-001 vaccine following receipt of two     doses; To assess the safety and reactogenicity of a monovalent inactivated influenza A/H7N9     vaccine (A/H7N9 IIV; two doses) administered with or without MF59 adjuvant following     immunization with two doses of M-001 vaccine or placebo, and to assess the serum     hemagglutination inhibition (HAI) antibody responses to the A/H7N9 IIV virus after receipt of     the first and second dose of MF59 adjuvanted or non-adjuvanted A/H7N9 IIV when administered     to adults following receipt of placebo or two doses of M-001 vaccine.   "
17331|NCT03058679|"     This protocol is designed to compare the effectiveness of two dietary interventions for     patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean     style diet (MSD) that has been demonstrated to have numerous other health benefits. The two     diets will be compared in terms of their ability to resolve both the symptoms and bowel     inflammation that characterize this debilitating disease.   "
17332|NCT03058666|"     Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation     and instillation of liquid surfactant to the airway.   "
17333|NCT03058653|"     On the Intensive Care Unit doctors give a lot of fluid to patients in order to improve their     blood pressure, amount of urine made or to let doctors stop drugs that are needed to keep     blood pressure up. Doctors normally give patients 500ml of fluid over 25 minutes as standard,     however it is very difficult to know if giving those fluids and how much fluid will help (it     does in some but not others). If a person gets too much fluid this can also cause problems     such as fluid in lungs, poor kidney function, or swelling in the limbs.      The LidCo Rapid monitor lets the Intensive Care Unit (ICU) team know the amount of blood the     heart pushes out with each beat (Stroke volume). It works by following the tracing off the     arterial line (Blood pressure monitor) that has been inserted as part of the standard care of     a patient on the ICU. It does not need any other invasive procedures or drug administration     to work.      This study is using this monitor to see if it can identify a method of improving the     administration of intravenous fluids on the Intensive Care Unit. The study is looking to see     if it can identify whether giving a small amount of fluid first identifies people who will     benefit from more fluid and those that won't.   "
17335|NCT03058627|"     The aim of this study is to evaluate the effect of routine FFR-guided complete     revascularization with PCI compared to conservative management in patients with concomitant     coronary artery disease who are undergoing TAVI.   "
17349|NCT03058445|"     Using an ultrasound echocardiography , we will measure the time to turbulance T2T from     injecting saline into the central venous catheter CVC to the appeareance of turbulance on the     screen using an MMode. The T2T will be compared with Chest X Ray CXR measured distance from     the tip of the CVC to the carina.      We are trying to evaluate if there is a significant correlation between the two measurements.   "
17350|NCT03058432|"     Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal     Carcinoma   "
17336|NCT03058614|"     This study will be a randomized controlled study comparing the use of two clinical management     strategies in nephrostomy tube management following percutaneous nephrolithotomy (PCNL). The     first strategy entails using contrast-enhanced ultrasound (CEUS) to evaluate the renal     collecting system (1). This is a new imaging approach applying ultrasound machines with     special software in combination with intraluminal ultrasound contrast agent (Lumason)     injection, which is an FDA-approved ultrasound contrast agent (2). The second strategy is a     nephrostomy tube capping trial combined with low dose non-contrast computed tomography (CT)     scan, one of the most frequently utilized clinical management strategies currently used in     clinical practice (3).   "
17337|NCT03058601|"     Cohort study using data from Clinical Practice Research Datalink (CPRD). The study cohort     includes all patients who received at least one prescription for ticagrelor for the first     time between December 2010 and March 2015, following ACS. Patient baseline characteristics     will be described: (Age, Gender, Body Mass Index, Smoking status, Sociodemographic status),     type of ACS and interventions, CV history and comorbidities, bleeding and respiratory     history.      The following outcomes will be examined: Incidence of vascular events (composite MI, Stroke,     vascular death, specific vascular event and all cause death), incidence of bleeding and     incidence of dysponea. Time to event for vascular events, bleeding and dyspnoea.   "
17338|NCT03058588|"     The aim of this study is to look for predisposing mutations in patients and relatives     affected by AML and MDS with familial history of myeloid or, less frequently, lymphoid     malignancies. Taking advantage of a next generation sequencing (NGS) platform, screening for     known and unknown mutations potentially associated with the disease will be done. The     screening will be performed on affected and unaffected family members, in order to outline     new pedigrees that either validate previous findings or constitute novel discoveries.   "
17339|NCT03058575|"     This is a randomized, 2-period crossover study aimed at assessing the effect of taking a food     supplement containing a blend of microbial accessible carbohydrates on the diversity of the     gut microbiome. Impacts to the skin, scalp and oral microbiomes; blood inflammatory     biomarkers; quality and quantity of sleep; gastrointestinal quality of life; bowel habits,     and facial skin features will also be evaluated.   "
17340|NCT03058562|"     The study will investigate the effects and the safety of a single-dose of ABX-1431 HCl on     tics and other symptoms of Tourette Syndrome.      During part 1 (periods 1 and 2) each patient will receive study drug once and placebo once.      Patients who complete part 1 with adequate clinical safety will be offered the option to     participate in part 2 (periods 3 and 4) and again willl receive study drug once and placebo     once where, in contrast to part 1, administration will take place with a standard high fat     meal.   "
17341|NCT03058549|"     This study investigates the effectiveness of a program to strengthen the relationships of     disadvantaged expectant couples, and to increase co-parenting, father involvement, and     economic stability. Couples are randomly assigned to Family Expectations or a control group,     and assessed at baseline and one year.   "
25147|NCT02956512|"     To evaluate the interaction of food on the pharmacokinetics of Dexibuprofen 300 mg (Apsen     Pharmaceuticals A / S.), after single dose oral administration to healthy subjects of both     sexes, under fasting and fed conditions.   "
17343|NCT03058523|"     Infants have an inborn preference for sweet and umami flavours and dislike sour and bitter,     but there is evidence that sensory experiences beginning early in development can modify     these preferences in favour ultimately of healthier food choices. Babies are first exposed to     flavour in utero and then later through breast/formula milk. This can be manipulated to     influence liking and consumption of individual foods with specific high-intensity flavours     postnatally. There are no prospective studies evaluating the impact of increasing maternal     fruit and vegetable intake during late pregnancy on a child's subsequent acceptance of fruit     and vegetables, particularly those with a sour/bitter taste. The hypothesis is that an     intervention to increase maternal intake of fruit and vegetables in late pregnancy will     enhance fetal flavour exposure and make infants more likely to accept a wide variety of fruit     and vegetables in childhood. Before testing this hypothesis, the investigators need to     evaluate the general acceptance and taste profile of the fruit and vegetable formats that we     intend to offer to pregnant women.   "
17344|NCT03058510|"     ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery     disease.      The aim of the study is to analyze the outcomes of main vessel stenting on side branch in     calcified bifurcation lesion and identify preprocedural predictors of side branch     complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain     optical coherence tomography (FD-OCT).   "
17345|NCT03058497|"     To ascertain whether home-based nocturnal TLA usage over a 12 month period can reduce     exacerbations and improve asthma control and quality of life as compared to placebo, whilst     being cost-effective and acceptable to adults with poorly-controlled, severe allergic asthma.   "
17346|NCT03058484|"     The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to     bring prevention of HIV services to communities using community health workers (CHWs). The     intervention aimed to integrate community-based maternal and child health services with HIV     prevention, treatment, and care—bridging the gap between women and facility, and enhancing     the potential benefits of Option B+. Option B+ is the current World Health Organization     recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan     Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals     like CHWs can be key partners in the delivery and/or enhancement of health services in the     community.      The study focuses on whether this approach: increases retention in care; improves adherence     to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy     and the timing of initiation. Investigators hypothesize improvements along primary and     secondary outcome indicators in the treatment group. This evaluation helps illuminate both     the impact and feasibility of the intervention, and the role that CHWs may play in the     elimination of mother-to-child transmission services.   "
17347|NCT03058471|"     This is a single center, prospective, randomized controlled open label trial with a one sided     cross over design to compare the efficacy of initiating Methotrexate(Mtx) in early post     Chikungunya induced arthritis (4-12 weeks after onset) with Non Steroidal Anti inflammatory     Drugs(NSAID) alone.   "
17353|NCT03058393|"     The goal of this study is to analyze patient:provider communication surrounding the     discussion of difficult clinical conversations such as knee replacement options. This study     will also examine how using the teach-back communication technique can improve communication     between patients and providers. Orthopedic residents, fellows, physician assistants, and     attendings that agree to participate will be consented. Patients, who are likely to engage in     a difficult clinical conversation, such as those who have a clinical indication for a Total     Knee Replacement or a Partial Knee Replacement, will be recruited from participating     providers clinical schedules. Patient:provider interactions will be recorded and then the     providers will attend a 1 hour education lecture about how to use teach-back. After attending     the lecture, additional patient:provider interactions will be recorded and analyzed via a     qualitative approach. Additionally, providers will participate in a semi-structured interview     to capture their perceptions of teach-back and what challenges and benefits they may derive     from using it.   "
17354|NCT03058380|"     The primary objectives of this study are to apply best-practice stated-preference methods to     quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty     treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer     stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference     data, estimate the relative importance of treatment features and outcomes, and estimate     maximum acceptable risks for given benefits and minimum acceptable benefits for given harms.     This study proposal describes plans for the patient stated-preference survey.   "
17355|NCT03058367|"     This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg     and 1980mg daily) in reducing body weight in overweight and moderately obese subjects   "
17392|NCT03057886|"     This study compares the use of the SPOT ON thermometer with the oral, esophageal in     participants submitted to general and the oral thermometer to spinal anesthesia, from the pre     op, intra and post op stages, evaluating the accuracy of this new monitor against the already     consecrated one by literature. The Investigators will analyze in three different types of     anesthesia (general, spinal and pediatric population).   "
17356|NCT03058354|"     Propofol is a commonly used anaesthetic with rapid recovery and less side effects and total     intravenous anaesthesia (TIVA) with propofol is a common technique now. The reduction on     certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.      Recent case report proved the analgesic effect of propofol infusion. However other animal and     clinical studies showed controversial result.      The aim of this retrospective study is to investigate the postoperative analgesic effects and     side effects of intraoperative TIVA with propofol in patient undergoing surgery at Queen Mary     Hospital, Hong Kong between 2014 to 2016.   "
17357|NCT03058341|"     Propofol is one of the most commonly used intravenous anaesthetic drugs both for induction     and maintenance of general anaesthesia. Some of the advantages of total intravenous     anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric     pollution, better wake up profile and a more favourable intracranial physiology. However, the     need for a reliable intravenous access, specialized pumps, pain on injection and potential     concerns regarding awareness are some reasons that preclude more common use.      Postoperative dental pain produces an inflammatory pain model. Since propofol has     anti-inflammatory effects, it may have significant analgesic effects in patients undergoing     dental surgery. To the best of our knowledge, there are no randomized controlled trials     comparing the effects of TIVA propofol and inhalational anaesthetic on postoperative dental     pain. The aim of this study is to investigate the effect of TIVA propofol on postoperative     pain scores, analgesic consumption, and adverse effects in patients undergoing dental     surgery. This will help determine whether propofol may be a useful analgesic adjunct in     dental surgery.   "
17358|NCT03058328|"     The purpose of this study is to describe numerical and functional changes in the white blood     cell efter surgical trauma. Further, observed immune cell changes correlate to heart rate     variability and cognitive function will be assessed.   "
17359|NCT03058315|"     The main purpose of the study is to investigate the importance of patients' beliefs regarding     staying active despite low back pain, among patients referred from general practice to     secondary care treatment in Denmark. It is hypothesised that patients believing that staying     active will help them recover will have higher odds of a 30%-improvement in The Roland Morris     Disability score after 52 weeks compared to patients disagreeing that staying active will     lead to better recovery.   "
17360|NCT03058302|"     This project aims to contribute to the development of a community mental health care system     while directly serving the conflict affected population in east Ukraine. This project is     being supported by USAID's Victims of Torture Fund. In the Spring of 2015, the Johns Hopkins     University (JHU) Applied Mental Health Research Group (AMHR) was invited to make a site visit     to Ukraine with USAID to make an initial assessment of current mental health problems,     service capacities, and treatment need. AMHR and USAID were requested by community-based     partners to provide training and support in evidence based trauma treatment for people     affected by war and displacement. Extensive conflict within the borders of Ukraine is a new     experience for most Ukrainians, and local psychologists and psychotherapists were not     prepared for wide-spread need or trained in appropriate methods of treatment for affected     populations. JHU and USAID began activities in Ukraine in June 2015 and have identified the     counseling intervention, Common Elements Treatment Approach (CETA), as appropriate and     relevant for this context. Community providers from the three trial sites (Kyiv, Kharkiv, and     Zaporizhia) have been trained in CETA as counselors and local supervisors.      An ongoing training and supervision model (Apprenticeship Model) is being implemented in the     three study sites. These three sites contain significant numbers of military veterans     (demobilized soldiers from the ongoing conflict) and internally displaced persons (IDPs).     Adult IDPs and Veterans from the three study sites will be recruited and screened to identify     those with elevated depression and/or posttraumatic stress symptoms and impaired functioning.     This study will be conducted as a 3-armed randomized controlled trial. This study will test     to see if both the long and a short version of CETA are effective compared to a wait-control     condition.   "
17361|NCT03058289|"     This study evaluates the intratumoral administration of escalating doses of a novel,     experimental drug, INT230-6. The study is being conducted in patients with several types of     refractory cancers including those at the surface of the skin (melanoma, head and neck,     lymphoma, breast) and tumors within the body such (pancreatic, colon, liver, lung, etc.).     Sponsor also plans to test INT230-6 in combination with anti-PD-1 antibodies.   "
17362|NCT03058276|"     This experimental research studies the efficacy of two different treatments for inhibitory     control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction     Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral     prefrontal cortex.   "
17363|NCT03058263|"     This study aimed to evaluate the effect of Neostigmine partial dose towards neuromuscular     blockade of rocuronium   "
17364|NCT03058250|"     This is a prospective randomized controlled trial looking at the utility of intraoperative     transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy.     Patients in the control group will have standard of care, patients in the TEE group will have     standard of care and TEE monitoring throughout. Intraoperative and postoperative variables,     such time to extubation, postoperative cardiac and pulmonary complications, intraoperative     fluid and vasopressor use will be assessed.   "
17365|NCT03058237|"     Part 1        -  To evaluate the pharmacokinetic (PK) profile of Arbaclofen Placarbil (AP) and R-baclofen          following dosing of Arbaclofen Placarbil Modified Release (MR) Prototype A Tablet and          Arbaclofen Placarbil MR Prototype B Tablet in healthy subjects        -  To determine the relative bioavailability of AP and R-baclofen following dosing of          Arbaclofen Placarbil MR Prototype A Tablet and Arbaclofen Placarbil MR Prototype B          Tablet compared to the reference Arbaclofen Placarbil Sustained Release (SR) Tablets          (low dose)        -  To determine the relative bioavailability and PK of AP and R-baclofen following dosing          of the selected MR prototype formulation(s) in the presence of beverage        -  To provide additional information on the safety and tolerability of single doses of AP      Part 2        -  To evaluate the PK profile of AP and R-baclofen following dosing of Arbaclofen Placarbil          MR Prototype Tablets in healthy subjects        -  To determine the relative bioavailability and PK of AP and R-baclofen following dosing          of Arbaclofen Placarbil MR Prototype Tablets compared to the reference Arbaclofen          Placarbil Immediate Release (IR) Capsule        -  To provide additional information on the safety and tolerability of single doses of AP        -  To determine the relative bioavailability and PK of AP and R-baclofen following dosing          of a selected MR prototype formulation in the fed state (optional)        -  To explore a possible in vitro in vivo correlation/relationship (IVIVC/IVIVR) for the          Arbaclofen Placarbil MR Prototype Tablet Formulations      Part 3        -  To determine the relative bioavailability of the selected Arbaclofen Placarbil MR          Prototype Tablet in the presence of either beverage or food and/or        -  To evaluate the PK profile (dose proportionality) of AP and R-baclofen following dosing          of the selected Arbaclofen Placarbil MR Prototype A + B Tablet at different dose levels          in healthy subjects        -  To provide additional information on the safety and tolerability of single doses of AP   "
17366|NCT03058224|"     This is a randomized, double-blind, placebo-controlled exploratory trial to investigate     efficacy and safety of food supplement IGN-ES001 in patients with chronic widespread pain     (CWP) with or without fibromyalgia (FM).   "
17391|NCT03057899|"     Objective: The aim of this study was to investigate the efficacy and safety of a mixed     extract of fenugreek seed and Lespedeza cuneata (TFG) for the treatment of testosterone     deficiency syndrome (TDS).      Design: Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per     day for 8 weeks.      Outcome measures: The primary efficacy variable was the change from baseline in the Aging     Males' Symptoms scale (AMS), as well as levels of serum total testosterone and free     testosterone. Secondary efficacy measurements included changes from baseline in the number of     'yes' answers on the Androgen Deficiency in the Aging Male questionnaire (ADAM), levels of     serum total cholesterol, HDL-C, LDL-C, triglyceride, perceived stress scale (PSS-10), all     domain scores of the International Index of Erectile Function (IIEF), as well as changes in     body composition.   "
17367|NCT03058211|"     Hypothesis: The novo cardiovascular events (CVE)in patients with severe community-acquired     pneumonia (CAP) are frequent (17%) and could be associated with both direct pneumococcal     myocardial invasion, toxin delivery (pneumolysin) or different biomarkers (histones,     NETs(neutrophil extracellular traps), IL (Interleukin)-1b,h-Fabp (heart-Fatty acid bindding     protein) ).The CVE frequency and its impact on outcome in patients without prior heart     disease (CP) has not been studied.      Objectives:1) To determine the incidence of myocardian injury (MI) and CVE in patients with     CAP without CP evaluated by non-invasive techniques (Echocardiograph and MRI) and biomarkers     levels (Tn-I (Troponin I), h-Fabp, NT-proBNP (N-terminal pro-brain natriuretic peptide)     histones, NETs, IL 1b); 2) To assess if DMA and CVE are related to the etiology and their     impact on outcome , 3) To investigate the presence of myocardial scarring by MRI and its     relationship with etiology and MI, and 4) To identify prognostic factors of DMA and CVE to     determine level of risk.   "
17368|NCT03058198|"     The epidermal growth factor receptor variant Ⅲ(EGFR vⅢ) is commonly detected in high-grade     gliomas, which is also an important epitope in EGFR-targeted therapies and correlated to poor     prognosis. However, detection of this mutant usually needs resected tumor samples. For biopsy     samples, test results may not represent the EGFR vⅢ status of the whole tumor tissues because     of the heterogeneity of tumor. It is also not applicable for patients who are not suitable     for surgical procedure due to the tumor location or patients' general conditions. Because of     the importance of the epidermal growth factor receptor (EGFR) signal pathway in oncogenesis,     maintenance, and progression of high grade glioma, there has been an intense effort to     develop noninvasive molecular imaging approach for the selection and monitoring of     EGFR-targeted therapies.      Based on investigators' previous study, investigators plan to perform PET scanning on the     participants with high grade gliomas after the injection of the second generation of EGFR     tracer ,89Zr-ABT806, which can be specifically binded to EGFR vⅢ . After fusing the PET and     MRI images, investigators precisely obtain the tissue from thehot-spot on the PET image     through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be detected by     molecular methods to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and     quantitatively. Investigators' final goal is to detect EGFR vⅢ by noninvasive molecular     imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted     therapies.   "
17369|NCT03058185|"     Laminopathies and emerinopathies are complex group of rare disorders due to mutations in     A-type lamins (LMNA) and Emerin (EMD) genes. Among them, disorders affecting skeletal and/or     cardiac muscles are the most frequent clinical manifestations, with cardiac disease being a     major cause of death. Remarkable progress has been made in the description of the clinical     and genetic spectrum of these diseases since the 1990's. Until now, precise     phenotype/genotype relations remain elusive. As for several other neuromuscular disorders,     apart from symptomatic treatments, there is currently no specific treatment to prevent or     slow down the progression of the disease. The OPALE registry is a multicentre web-based     registry dedicated to laminopathy and emerinopathy French patients. OPALE has been approved     by ethical and regulatory authorities. Its main inclusion criteria is the presence of a     proven pathogenic LMNA and/or EMD gene mutation.      The OPALE objectives are to provide a tool allowing detailed capture of patient genetic,     neurological, cardiological, endocrinological and respiratory assessments, in order to allow     i) precise disease natural history, ii) evaluation of different disease complication     frequency and iii) identification of prognosis factors.   "
17370|NCT03058172|"     The aim of this research project is to better understand the reciprocal influence of visual     and olfactory systems on cerebral activity evoked by odors and visual stimuli. Given the     importance of olfacto-visual learning in expert situations, the degree of expertise in     olfaction will also be considered. In addition, the investigators will try to better     understand the differences between expert and non-expert populations in olfaction through     different levels of approach: sensory, genetic and cerebral. To achieve this, the     investigators will use psychophysical tests, genetic analyzes and a non-invasive technique,     functional magnetic resonance imaging (fMRI) to measure the brain activity of human subjects     - novices or experts in olfaction - in response to different visual and olfactory stimuli.   "
17371|NCT03058159|"     The aim of the study is to investigate the functional connectivity between the brain regions     of the default mode network before and after a 40 min nap slot in the afternoon. The     hypothesis is that connectivity between brain regions will be decreased after the nap as     compared to before the nap.   "
17372|NCT03058146|"     Physical activity interventions with older adults can improve brain health; however most     interventions have been performed in gym-like settings that reach a small sector of the     senior population. Since not everyone can access a gym, it is important to study whether     brisk walking in real world environments can also help brain health. This study will use     mobile health devices to help older adults independently walk for brain health, thus     representing a critical step towards the dissemination of physical activity intervention     programs aimed at preserving cognitive function in aging.   "
17373|NCT03058133|"     Bayesian models of perception represent a promising approach to describe information     processing by the brain. Predictive coding hypothesizes a process in which top-down     expectations are continuously compared across multiple hierarchical levels with bottom-up     sensory inputs and the differences or error signals are propagated in a bottom-up direction.     The investigators hypothesize that strong expectations, are best investigated in expert     processes such as face and voice recognition in humans. Individuals in complex social systems     need to extract socially relevant information in a fast and efficient manner; hence, the     majority of humans constitute face, voice and gender experts. Nevertheless, linking such     combined abilities to brain activity with regards to the predictive coding hypothesis has not     been attempted.Our results suggest asymmetric contributions of visual and auditory signals to     the gender classification task. This sensitive psychophysical procedure is implemented in a     decoding approach using fMRI and multi-voxel pattern analysis (MVPA). The investigators plan     to test whether cortical areas implicated in processing auditory and visual gender signals     show similar asymmetries.   "
17374|NCT03058120|"     This was a prospective randomized, controlled trial designed to quantify the reduction in     cost and length of stay of early discharge of emergency department patients evaluated for     acute myocardial infarction, who are deemed to be low risk based on a modified HEART score (a     score that incorporates troponin biomarker, ecg, patient characteristics, and physician     clinical judgment).   "
17375|NCT03058107|"     Cancer is a worldwide spread disease with high prevalence and incidence, often of poor     prognosis because it is typically diagnosed in an advanced stage. Another reason for this     prognosis is the presence of malnutrition, on the one hand because of a diminished intake     (due to anorexia), and on the other hand because of tumor-induced hypercatabolism. The result     is a pathological state of the body called cachexia, generally defined as a weight loss >     5% during the last 6 months before diagnosis. It had already been demonstrated that correct     nutrition in such patients can limit morbidity, while promoting progression-free survival as     well as well-being. The pilot study, previously performed by the investigators, was the first     to suggest that Nutrition Therapy, based on the ESPEN guidelines and resting energy     expenditure measured by indirect calorimetry, can promote overall survival. The aim of this     project is to validate these preliminary results in a larger RCT (randomized controlled     double-blind trial), to promote Nutrition Therapy as a novel modality in its own right in the     treatment of cancer, rather than being merely supportive.   "
17376|NCT03058094|"     A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and     Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR     TKI.   "
17377|NCT03058081|"     Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of     chronic obstructive pulmonary disease (COPD). However, its implementation is challenging     particularly as regard exercise training. High flow ventilation in reducing work of breathing     and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute     effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients   "
17378|NCT03058068|"     A Safety Run-In will be followed by a Double-Blinded Randomized Phase. All subjects shall     meet the inclusion/exclusion criteria, and will be evaluated prior to the scheduled infusion     to establish baseline.      There will be 3 subjects in the safety run-in phase and 15 subjects in the double-blinded     phase.   "
17379|NCT03058055|"     The BEST study will investigate the feasibility of cognitive interventions in a randomized,     placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal     subjects and engage them in one of three cohorts over an 8 week period, including active     reading vs. origami study arms and a placebo group without structured cognitive intervention.   "
17380|NCT03058042|"     The objective of this study is to compare the effect of outpatient pelvic floor muscle     training versus home pelvic floor muscle training in the treatment of stress urinary     incontinence. The hypothesis of this study is that home pelvic floor muscle training is as     effective as outpatient pelvic floor muscle training for the treatment of stress urinary     incontinence.   "
17381|NCT03058029|"     This study will asses the effect of Gelesis200 on body weight in overweight and obese     subjects with prediabetes and metformin-treated type 2 diabetes.   "
17382|NCT03058016|"     This clinical study is designed to evaluate the providing of a computational prediction     engine for optimization of personalized nutrition      Personalized recommendations for effective diet, lifestyle and activities based on the     patient's parameters measurements and reactions will be provided on a bi-weekly basis, all     Lab tests and dietician control will be performed twice a month.   "
17383|NCT03058003|"     To investigate the use of balance as a screening tool for Central Sensitization, a condition     of the nervous system that is associated with the development and maintenance of chronic     pain. This is done by comparing the scores of a gold standard screening tool (the Central     Sensitization Inventory) with balance data.   "
17384|NCT03057990|"     This is a phase I study designed to assess the maximum tolerated dose (MTD) of pyrimethamine     and provide the recommended Phase 2 dose (RP2D) for the treatment of intermediate/high-risk     MDS that is refractory to or relapsed after treatment with azanucleosides.   "
17385|NCT03057977|"     The aim of the study is to investigate the safety and efficacy of empagliflozin versus     placebo on top of guideline-directed medical therapy in patients with heart failure with     reduced ejection fraction.   "
17386|NCT03057964|"     This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser)     and fractional photothermolysis in the cosmetic improvement of post surgical scars.All     subjects will be offered at the time of the dermatologic procedure, an option to treat the     post surgical scars with early combined PDL and fractional photothermolysis.      Part A is a non-randomized study design and subjects will have the choice of whether or not     they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs.     control design.      The experimental group will have a total of 6 visits: 1 standard of care suture removal     visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1     standard of care suture removal visit and 2 follow up visits.      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion     criteria will be considered for enrollment.      This study is a pilot study designed to determine feasibility of this procedure.   "
17387|NCT03057951|"     The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on     top of guideline-directed medical therapy in patients with heart failure with preserved     ejection fraction   "
17388|NCT03057938|"     Phase II, open-label clinical trial with a medicinal product. A total of 30 subjects will be     included in the study.      All participants will receive a single intravenous dose of 300 MBq of FBB. A 20-minute PET     image should be acquired starting at approximately 90 minutes after intravenous injection of     FBB.      The present proposal aims are: to assess safety of a single dose of FBB followed by PET scan     in individuals with subjective cognitive decline (SCD), to determine the number of SCD     subjects with positive visual FBB-PET scan, to determine the number of SCD subjects with     positive standardized uptake value ratios (SUVRs) of FBB-PET scan and to explore the cortical     pattern of amyloid deposition in SCD subjects.   "
17389|NCT03057925|"     Percutaneous microwave ablation(MWA) was reported as an effective modality for the management     of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients     with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one     group to treat with MWA and the other group to receive regular ultrasonic follow-up without     any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical     symptoms.   "
17390|NCT03057912|"     This is an open-label and triple cohort study of the safety and efficacy of TALEN and     CRISPR/Cas9 to possibly treat HPV Persistency and human cervical intraepithelial     neoplasiaⅠwithout invasion.   "
17394|NCT03057860|"     Atopic dermatitis (AD) constitutes significant burden to patients, families, and healthcare     systems.      About 60% of all patients with AD are adults. Patients with moderate-to-severe AD cannot be     sufficiently controlled with topical treatments alone and require intermittent or continuous     treatment with systemic immunomodulating agents or UV-therapy.      Systematic reviews indicate that although 12 different interventions for moderate-to-severe     AD have been studied in clinical trials, strong recommendations are only possible for the     short-term use of cyclosporin A (CSA).      Methodological limitations in the majority of trials such as the choice of non-validated     outcomes and outcomes that are not most relevant to patients prevent evidence-based clinical     decision making.      Pharmaceutical treatment of patients suffering from AD is diverse and frequently not in line     with the current guidelines (for example S2-guideline in Germany).      Systemic anti-inflammatory and immune-modulatory therapies include several conventional     immunosuppressive agents such as glucocorticosteroids, CSA, methotrexate (MTX), azathioprine     (AZA), interferon-gamma (IFN-γ), intravenous immunoglobulins (IVIG), and mycophenolate     mofetil (MMF) or mycophenolate acid. Dupilumab is the first biologic treatment for AD with     very promising results in clinical trials. Other biologic treatments are currently being     developed for the treatment of moderate-to-severe AD.      Large head-to-head trials are missing so that long-term effectiveness of systemic     interventions for moderate-to-severe AD is speculative.      In this situation, clinical registries can provide valuable information for evidence-based     clinical decision making.      Objectives: Establishment of a national evidence-based clinical registry and research network     with the following objectives:        1. Characterization of medical care and pharmaceutical therapies of adults suffering from          moderate-to-severe AD. The perspective of the patient (utility, treatment goals, quality          of life, and treatment satisfaction), sequence of treatments, and change of treatments          will be a primary focus.        2. Investigation of comparative effectiveness, tolerability and safety of systemic          therapies for moderate-to-severe AD.        3. Development of a platform for further investigations, such as pragmatic clinical trials,          epidemiologic studies, outcomes research, immunologic and molecular research (given          approval of responsible ethics commission).   "
17395|NCT03057847|"     Incorporating HCV treatment into opioid maintenance treatment program clinical protocols is     an innovative health care delivery model that has been associated with improved HCV treatment     uptake in non-pregnant, drug-using populations. This medical home approach would combine     HCV and opioid maintenance treatment into one treatment regimen and incorporate the expertise     of obstetricians, hepatologists, substance abuse treatment providers and pediatricians into     one comprehensive clinical care model. The purpose of this study is to evaluate the     feasibility/acceptability of a combined, peripartum HCV and opioid maintenance treatment     program on adherence to HCV treatment regimens and evaluate the rate of IVDU recidivism, HCV     reinfection and health related QOL in women with OUD during the first postpartum year.      The protocol involves three separate study phases. All 3 study phases will occur with support     from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment     and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood     and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will     undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum.     Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8     and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months     after treatment completion. Treatment effectiveness and SVR will be evaluated at 3 months and     rates of IVDU recidivism, HCV reinfection and patient centered outcomes such as health     related quality of life (QOL) will be assessed at 6, 9 and 12 months following treatment     completion.   "
17396|NCT03057834|"     Investigators plan a prospective cohort study with an adaptive design based on physical     function status. The design will involve tracking the number of women recruited with physical     function impairment and those without any functional impairment. Investigators aim to recruit     similar numbers of women in each group. If investigators find unequal numbers, they will     adapt recruit strategies based on a woman's functional status.   "
17397|NCT03057821|"     The investigator's plan to determine whether pre-operative skin preparation with hydrogen     peroxide alters rates of P acnes culture positivity. They hypothesize that pre-operative skin     preparation with hydrogen peroxide will reduce rates of P acnes culture positivity.   "
17398|NCT03057808|"     The purpose of this study is to enroll approximately 450 subjects to see if a behavioral     weight management program is successful in helping military female personnel who are pregnant     or post-partum to manage their weight during and after their pregnancy.   "
17399|NCT03057795|"     This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell     transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back     or does not respond to treatment. Monoclonal antibodies, such as nivolumab and brentuximab     vedotin, may interfere with the ability of cancer cells to grow and spread.   "
17400|NCT03057782|"     It is difficult to assess pain and agitation in the NICU population because for a multitude     of reasons including the pre-verbal nature of the patient population, the atypical pain     response of premature infants, and the use of muscle relaxing medications that exclude motor     response in pain assessments. Current assessment tools are based on physical exam and vital     signs. The investigators propose to study the role of EEG and palmar conductance (PD) as     additional tools in the assessment of pain and agitation   "
17401|NCT03057769|"     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to     30% of procedures. It accounts for substantial morbidity and represents a substantial cost to     health-care systems. European Society of Gastrointestinal Endoscopy and Japanese Society of     Hepato-Biliary-Pancreatic surgery guidelines and recently large-scale RCT recommended routine     use of NSAIDs indomethacin rectally before ERCP. Nonsteroidal anti-inflammatory drugs     (NSAIDs) have been shown to inhibit prostaglandin synthesis, phospholipase A2 activity, and     neutrophil/endothelial cell attachment, which is believed to play a key role in the     pathogenesis of acute pancreatitis.      Other possible mechanisms have been suggested in the occurrence of pancreatitis. Papillary     edema caused by manipulations during cannulation or endoscopic treatment has received the     most attention. The papillary edema may cause temporary outflow obstruction of pancreatic     juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis.     Topical application of epinephrine on the papilla may reduce papillary edema by decreasing     capillary permeability or by relaxing the sphincter of Oddi. A meta-analysis (including 2     existing RCTs and post-hoc analysis of our previous study) of papillary epinephrine spraying     compared with saline spraying or no intervention indicates a potential relative risk     reduction of PEP (RR 0.34, 95%CI 0.19-0.61). Papillary epinephrine spraying may be an     inexpensive and convenient alternative for prevention of post-ERCP pancreatitis. A large     pragmatic RCT to determine whether routine using papillary epinephrine spraying can reduce     post-ERCP pancreatitis is needed.   "
17402|NCT03057756|"     The principal objective is to evaluate a cure rate and number of adverse events of with     confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.   "
17403|NCT03057743|"     Pilot study using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast     cancer. Correlate baseline uptake and change in uptake after therapy with time to progression     and standard and experimental pathology assays of biopsy or surgical tissue. The target     population is up to 30 adult patients at least 18 years, with at least one site of disease     outside the liver by at least one type of standard imaging.   "
17404|NCT03057730|"     Gingival recession is a common defect among the American population. It is also a major cause     for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem.     Acellular dermal matrix, a human-derived grafting material has been put on the market for the     treatment of gingival recession. Treating gingival recession with this material has been a     validated treatment option for years.      However, treatment outcomes in two patient populations, namely those with thin biotypes and     those with thick biotypes, has not been investigated. This study will observe the primary     treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12     months post-surgery to observe short term outcomes; additional 24 months and 48 months     post-surgery to observe long term outcomes.   "
17405|NCT03057717|"     Administration of corticosteroids is standard practice for pregnant patients at risk of     preterm labour to reduce the risk of neonatal respiratory distress syndrome, intraventricular     hemorrhage, necrotizing enterocolitis and neonatal mortality. However, there is an unknown     effect of antenatal steroids on both fetal and neonatal immune function. The purpose of this     study is to demonstrate the effect of antenatal steroids on the size of the fetal thymus     gland.   "
17406|NCT03057704|"     Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection     of propofol to reduce the amount of pain during propofol injection. The investigators want to     study if giving the lidocaine through the IV while the forearm on the same limb has a     tourniquet applied to it to prevent washing out of the lidocaine prior to propofol     injection helps reduce propofol injection pain.   "
17407|NCT03057691|"     The purpose of this study is to evaluate how major depressive disorder or generalized anxiety     disorder could effect the prognosis of the patients post-ACS after PCI and whether the     treatment or improvement of depression and anxiety could improve their prognosis.   "
17409|NCT03057665|"     The goal of this study is the evaluation of an atomic magnetometer that is practical for     human biomagnetism studies. The investigators have built a device that has the necessary     sensitivity, and will be testing it on a small number of adults and approximately 30 healthy     pregnant subjects, in preparation for beginning pre-clinical studies of high-risk     pregnancies.   "
17410|NCT03057652|"     The purpose of this study is to develop an algorithmic-based evaluation and treatment     approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological     conditions.   "
17411|NCT03057639|"     This research trial studies the Adolescent and Young Adult (AYA) Cancers Clinical Model in     evaluating clinical, psychosocial, and health economic factors in adolescent and young adult     patients with cancer. Studying the Adolescent and Young Adult Cancers Clinical Model may help     doctors learn more about the effect of the AYA services on patient care, including clinical     (nurse navigation), psychosocial (social work), and economic (financial) areas.   "
17412|NCT03057626|"     This research trial studies late effects after treatment in patients with previously     diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide     which treatments for high-risk neuroblastoma are better tolerated with less side effects over     time.   "
17553|NCT03055767|"     The purpose of the research is to examine the outcomes of pediatric patients receiving     Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature     on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric     patients, specifically in the treatment of migraines.   "
17413|NCT03057613|"     A small group of skin cancers of the head and neck, called resected cutaneous squamous     carcinomas, are more aggressive than most cancers of this type, even after being treated with     standard therapy. This trial will use stronger treatment to look at the safety and     effectiveness (efficacy) of combining a drug called Pembrolizumab with radiation after a     cancer has already been treated to suppress secondary tumor formation in high risk cutaneous     squamous cell cancer of the head and neck.      Primary Objective To assess safety by looking at the people with dose limiting responses   "
17414|NCT03057600|"     CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in     patients of African ancestry and non-African ancestry with advanced triple negative breast     cancer. Multiple single-arm cohorts will be enrolled in which 800 mg BID CB-839 will be     administered in combination with the full approved dose of paclitaxel.   "
17415|NCT03057587|"     This study will be an observational, prospective trial that will measure the cerebral     oxygenation of infants scheduled to undergo general anesthesia at Boston Children's Hospital.   "
17417|NCT03057561|"     This project is designed to demonstrate equivalence of Dotarem enhanced LGE-CMR (late     gadolinium enhancement cardiac MRI) with Magnevist enhanced LGE-CMR from the standpoint of     visual image quality, quantitative image quality, and association with clinical outcomes.   "
17418|NCT03057548|"     The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with     ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial     fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one     year after an ablation procedure in comparison to a PVI ablation procedure, alone.      The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in     a reduction in recurrence of atrial arrhythmias at one year after ablation.   "
17419|NCT03057535|"     An abnormally high V̇E/V̇CO2 response to exercise is a key pathophysiological feature of     patients with chronic cardiopulmonary disease that is associated with adverse health     outcomes. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to     exercise has the potential to improve clinical and/or patient-reported outcomes. The     investigators of this trial will compare the effects of orally administered sodium chloride     (4 g, placebo) and sodium bicarbonate (0.3 g/kg of body mass) on ventilation, breathing     pattern, dynamic operating lung volume, gas exhange, cardiovascular, metabolic and symptom     parameters during symptom-limited, high-intensity, constant-work-rate cycle exercise testing     in healthy adults aged 20-40 years.   "
17420|NCT03057522|"     This will be a pilot study to determine if a 6 week home training program can increase     preferred step rate (cadence) in recreational runners. Increase in step rate has been     correlated with decreased stress at lower limb joints in runners. This has the potential of     decreasing overuse injuries in this population.      Research participants will have their preferred cadence evaluated at the beginning of the     study. The athletes will be randomly assigned to two groups. One group will continue to train     without intervention and the other group will train at a cadence of 10% higher than their     preferred step rate.      At the end of 6 weeks the participants will have their preferred cadence reevaluated using     the same method as pre-participation cadence was determined.      The investigators hypothesis the preferred running cadence of recreational runners following     the intervention will be 5-10% greater than prior to the intervention and the increased     cadence will be maintained for 6 months following the intervention.   "
17421|NCT03057509|"     This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron     emission tomography (PET) scanning as a way of assessing carcinoid tumors.   "
17422|NCT03057496|"     This study evaluates a novel collision warning device to help people with severe vision     impairment or blindness avoid collisions with obstacles. The main hypothesis to be tested is     that the device reduces the number of collisions with obstacles in everyday activities.   "
17423|NCT03057483|"     Rationale and background: Since 2013, IB has been performing passive pharmacovigilance     activities related to TIV. Objetive: To implement an active surveillance study as part of our     pharmacovigilance plan while passive surveillance activities will continue. Pharmacovigilance     data on TIV, via active surveillance, is being implemented in response to WHO requirements     for pre-qualification of TIV.      Study Design: This is a prospective cohort study. Population: Target groups for vaccination     defined by The National Immunization Program of Brazil: children between six months and five     years old; pregnant women; postpartum women (mothers until 45 days after birth); healthcare     workers; and elderly (people over 60 years old). Study Size: A total of 900 individuals (300     health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children     between six months and five years old), presenting for immunization with IB TIV, and who     agree to participate after providing Informed Consent.      Data Analyses: Descriptive approaches will be used to meet the defined objectives described     in the protocol, as well as formal statistical tests when appropriate.   "
17424|NCT03057470|"     The overall objective of this study is to investigate the glycemic response of a 0%, 50%,     100% and 150% bolus insulin correction (based on personal insulin correction factor) of     post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using     multiple daily injections (MDI) in a controlled, but clinically representative, experimental     setting.   "
17451|NCT03057119|"     Substance misuse is a common problem among HIV+ individuals. Research suggests that a     Screening, Brief Intervention, and Treatment (SBIRT) model can be effective in reducing     substance misuse in the general older adult population; however these findings have not been     verified in the more vulnerable HIV+ older adult population. The present study seeks to     address the problem of substance misuse in older HIV+ adults by piloting a SBIRT model for     older HIV+ adults in a in a primary care setting. Individual reductions in alcohol and drug     use can have significant effects on public health and safety when observed over a large     population at risk for substance use problems. With wider dissemination statewide, a     relatively low-cost intervention such as SBIRT could offer demonstrated benefits in this     population.   "
17607|NCT03055052|"     This study evaluates the effects of infant formula with higher protein level and improved fat     blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a     standard infant formula, while the other half will receive a infant formula with a higher     protein level and improved fat blend.   "
17425|NCT03057457|"     The NGAL TestTM is a particle-enhanced turbidimetric immunoassay for the quantitative     determination of neutrophil gelatinase-associated lipocalin (NGAL) in human EDTA plasma for     testing on automated clinical chemistry analyzer.      The First Indication for Use: An NGAL test result above the assay cutoff as an aid in the     risk assessment for the development of stage II or III acute kidney injury (AKI) within 1 day     of patient assessment in patients in the intensive care unit (ICU) who are hypotensive     (MAP<70 mmHg) and/or receiving vasopressor support. Second Indication for Use: In patents     with stage II or III AKI, NGAL measurement aids in the risk assessment of the development of     persistent (≥2 days) stage 2 or 3 AKI.      The Primary Objective for this clinical trial is to validate that the NGAL test using a     cutoff of 140 ng/ml shows clinical performance in predicting the development of moderate or     severe acute kidney injury within 1 day. The Secondary Objective is to validate that the NGAL     test shows clinical performance in predicting persistent moderate or severe acute kidney     injury during any contiguous 2 day interval.      It is anticipated that up to 20 Clinical Sites in US will participate in the trial. The study     sites will recruit consecutive patients meeting the inclusion and exclusion criteria who are     admitted to hospital in an ICU or critical care setting. Patients will receive their clinical     standard of care including standard laboratory and other testing as requested by each     subject's physician.   "
17426|NCT03057444|"     The aim of the study is to investigate, if resistant starch type III increases     butyrate-producing bacteria in the gut of (pre-) diabetic subjects. Diabetic blood parameters     are also of interest.   "
17427|NCT03057431|"     The investigators plan to assess the efficacy of standard and low dose HCTZ treatment in the     recurrence prevention of calcium-containing kidney stones. More specifically, the     investigators aim to assess the dose-response relationship for three different dosages of     HCTZ.      Study intervention: HCTZ 12.5 mg, 25 mg or 50 mg once daily per os for 24 or 36 months. In     addition, all patients in HCTZ treatment arms will receive state-of-the-art non-pharmacologic     recommendations for stone prevention according to current guidelines.      Control intervention: Placebo once daily per os for 24 to 36 months. In addition, all     patients in the placebo arm will receive state-of-the-art non-pharmacologic recommendations     for stone prevention according to current guidelines.   "
20437|NCT03018041|"     This is a long-term intervention study on the effects of marine n-3 PUFAs in renal     transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation     will have less decline in kidney transplant function compared to patients treated with     placebo.   "
17428|NCT03057418|"     This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of     Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive     non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients     non-treated before for В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade.      The study will be carried out in 4-6 Russian and Belarussian sites. The study will be     consisted of screening period, induction (obligatory) phase and supporting (non-obligatory)     phase of the investigational therapy and post-treatment follow-up period.   "
17429|NCT03057405|"     Background Correction of post traumatic and post-ablative orbita defects remains a challenge     for the maxillofacial surgeon. The purpose of such intervention is the restoration of both     function and aesthetics by anatomical reconstruction of the bony orbitawalls, with attention     to the orbitavolume. Unfortunately, the results of such interventions today are still     somewhat unpredictable.      The aim of this study is to determine whether 3D virtual planning combined with     intra-operative navigation can increase the predictability of the outcome in function and     aesthetics.      Study design Retrospective study. Demographic data, diagnostic and surgical parameters will     be collected of all patients undergoing orbital surgery between 01/01/2012 and 31/12/2016 at     the department. Pre- en postoperative orbit volume will be determined based on CT-analysis in     Brainlab software, and compared to the non-defected orbit.   "
17430|NCT03057392|"     Immersion to the neck before and during hemodialysis session may increase intravascular     volume, potentiate the ability to ultrafiltrate excess water, with less symptoms of shock,     muscle crumps etc.      The aim of the present study is to compare blood volume, hemodynamic and endocrine parameters     of chronic ESRD patients undergoing forth dialysis session in water immersion vs. control     regular session.   "
17431|NCT03057379|"     The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and     sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct     centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates     among adolescents ages 11-17.   "
17432|NCT03057366|"     The purpose of this study is to assess the mass balance (that is, cumulative excretion of     total radioactivity [TRA] in urine and feces) of pevonedistat following a single 1-hour     infusion of 25 milligram per square meter (mg/m^2) [14C]-pevonedistat intravenous (IV)     solution containing approximately 60 to 85 microcurie (mCi) (approximately 2.22-3.145     megabecquerel [MBq]) of TRA in participants with advanced solid tumors in Part A.   "
17433|NCT03057353|"     To measure ligamentum flavum thickness in patients with different nationalities, sexes,     heights, ages, and weights from Xinjiang Uygur Autonomous Region of China with CT, explore     the correlation between various factors and ligamentum flavum thickness, provide reference     for pedicle screw placement and lumbar decompression surgery, develop individualized surgical     programs, and can effectively reduce the incidence of unnecessary postoperative complications     induced by misplacement.   "
17452|NCT03057106|"     Durvalumab is a new type of drug for many kinds of cancer. It is considered immunotherapy     and not chemotherapy. Laboratory tests show that it works by allowing the immune system to     detect cancer and reactivate the immune response. This may help to slow down the growth of     cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in     animals and has been studied in more than 5000 people and seems promising.      Tremelimumab is a new type of drug for various types of cancers. It works in a similar way to     durvalumab and may improve the effect of durvalumab. Tremelimumab may also help slow the     growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink     tumours in animals and has been studied in over 1200 people and seems promising.   "
17453|NCT03057093|"     Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at     elevated risk.   "
17434|NCT03057340|"     Malignant tumor has become the leading cause of death in humans, and the number one killer in     malignant tumor is the lung cancer. Intensifying environmental pollution comes with rising of     the incidence of lung cancer and the high mortality,what's the worst that the 5-year survival     rate is only about 15%, accounting for first place in the malignant tumors, Exploiting for     novel antitumor technology and products comes to arrest growing attention of the governments     and businesses because of the uneffectively curbing of tumor threat to people's life and     health on conventional three treatments (surgery, radiotherapy and chemotherapy). Biological     and immunotherapy was voted to one of the ten big breakthrough in 2013 by Science magazine,     and considered as a new development direction for cancer treatment in the 21st century.      The existing immune treatment mainly includes: adoptive immune therapy, tumor vaccine     therapy, immune checkpoint-antibody therapy and other auxiliary therapy, and the adoptive     immunotherapy was researched and developeded former in addition the most mature treatment     among these therapies.      Recently, Dr Hu Hong - Ming's team put forward an innovative cancer treatment strategy: using     of autophagy role to capture tumor antigen for preparation of tumor vaccine. In this     strategy, the blocking proteasome activity of in vitro cultured tumor cells dealed with     Bortezomib (proteasome inhibitors) causes enrichment of short-lived protein (SLiPs) and     misfolded proteins (DRiPs) in autophagosome,called DRibbles corpuscle. Tumor vaccine maded     from collecting these DRibbles corpuscle preparation as, also known as the DRibble vaccine.      At present, clinical research has been carried out about Dribble liver cancer vaccine unit     with DC - CIK therapy in liver cancer in the second hospital of Nanjing nearly four years,and     more than 300 cases has been completed. Clinical research results show that Dribble vaccine     has good security, producing stronger immune response compared with the DC-CIK therapy alone.     But it is still no cognization for the efficacy and safety of DC-CIK joint DRibble lung     cancer vaccine in China, whether it is better than the current DC - CIK immune therapy,     needed for further clinical research and expected to provide a better immune treatment for     NSCLC patients.   "
17435|NCT03057327|"     The proposed study is a pilot and feasibility study designed to develop materials to enhance     early detection of melanomas among women at risk to develop melanoma due to indoor tanning,     having a family history of melanoma or a personal history of melanoma.      The hypothesis of this study is that women, who are engaged in health promotion by having     mammograms, will be able to assess the personal relevance of skin self-examination (SSE), be     interested in learning about SSE and able to implement SSE while they are partially disrobed     in the privacy of the changing room in the mammogram facility.   "
17436|NCT03057314|"     To improve the function and welfare of late stage solid cancer subjects by:        -  enabling subjects to benefit from a potentially promising drug under development        -  assessing initial evidence of improvement in Pain VAS score        -  assessing initial improvement in Performance Status (PS)        -  assessing initial improvement in oxygen saturation whenever it is feasible   "
17437|NCT03057301|"     Worldwide, glaucoma is the most common cause of irreversible blindness. The major risk factor     is raised pressure within the eye (intraocular pressure, IOP). IOP is typically measured     using Goldman applanation tonometry (GAT). This involves instilling anaesthetic eye drops and     using a probe to contact the cornea and obtain a pressure measurement. A major disadvantage     of GAT is that only limited numbers of pressure measurements can be obtained, whereas IOP is     known to vary throughout the day and in ¾ of people is highest during the night. The result     is that clinicians have poor understanding of patient's 24 hour IOPs and the effect that this     might have on their glaucoma. This is a serious limitation as the treatment of glaucoma     depends on lowering IOP.      Recently a new device has become available, designed specifically for home IOP monitoring.     The iCare HOME tonometer is a CE marked commercial device     (http://www.icaretonometer.com/products/icare-home-tonometer/) that can be used to gain     insight into 24-hour IOP fluctuations. We wish to determine the feasibility of home IOP     monitoring using this device. The iCare HOME tonometer depends on the patient performing     self-tonometry. Testing one's own IOP may be technically difficult and it is likely that     large numbers of patients will struggle with this.   "
17438|NCT03057288|"     It is a multicenter prospective observational study including consecutive patients with     esophageal tumor or rectum with indication for radiotherapy      The main objective of this study is to evaluate the feasibility of fiducial markers placement     under EUS guidance. The evaluation criteria are:        -  Success rate evaluation of the placement of two markers : one in the upper part of the          tumor and one in the lower part. Success of the procedure will be evaluated by the          endoscopist at the end of the procedure. Pictures of the markers will objectify the good          placement of the markers.        -  Complications (early within 24 hours and late complications) such as pain, bleeding,          perforation, infection, migration of the markers        -  The length of the procedure        -  The costs (procedure, hospitalization)        -  The clinical efficacy, by studying the decrease of the estimated target volume, the          decrease of the dose delivered to the healthy tissue and the improvement of positioning          of the irradiation beams by the radiotherapy technician        -  The presence of the markers at the end of the radiotherapy   "
17439|NCT03057275|"     To study the equivalence of the Monica Novii™ Patch System in patients admitted for     threatened pre-term labor and for pre-term labor & delivery from 32 +0 weeks gestation by     determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR),     Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer     (TOCO) UC and photo plethysmograph MHR FDA approved predicates.   "
17440|NCT03057262|"     Intra-articular temporomandibular disorders are often related to pain in the area of     temporomandibular joint, ear and temple. The aim of the study was to investigate the     efficiency of anterior repositioning splints for the management of pain related to     temporomandibular joint disc displacement with reduction.   "
17441|NCT03057249|"     The purpose of this study is to evaluate the consequences of 3 selected surgical procedures     on abdominal wall perfusion in order to help to reduce postoperative complication related to     inadequate tissue perfusion. The selected surgical procedures are a) abdominoplasty, b)     breast reconstruction with a free flap from the lower abdomen and c) endovascular stenting of     an abdominal aorta aneurism. These operations are all standard surgical procedures frequently     performed at the University Hospital of North Norway, Tromsø. The abdominal wall perfusion     will be evaluated with the use of Dynamic Infrared Thermography (DIRT).   "
17442|NCT03057236|"     This is a pilot feasibility study of a small randomized controlled trial (RCT)design to     evaluate participation in a Cognitive Behavioral Coping Skills (CBCS) group intervention     versus standard of care in patients with hepatitis C undergoing antiviral treatment. The     primary objectives are to (1) examine effect size (ES) estimates of key outcomes to provide     essential data to inform a larger efficacy trial, (2) determine whether clinically     significant improvements occurred in any key outcomes, and (3) evaluate study feasibility and     patient acceptability. Study findings will inform a larger efficacy study of the CBCS-HCV.   "
17443|NCT03057223|"     Medical titanium plates are routinely used in fixing mobilized bone segments in jaw     surgeries. Generally these plates are commercialized with standard construction     specifications. Thus they should be repeatedly bended and arched to match the contour of     anchored jaw bones before located in place and fastened by screws. To prevent stress fatigue     induced by plate bending and improve structural design, we utilized the three-dimensional     printing technique and developed a new production procedure in fabricating customized     titanium plates according to each patient's specific skeletal contours and dimensions derived     from medical imaging data. In general, the three-dimensional printing of customized implants     are expected to facilitate surgical operation, reduce application duration and improve     precise restoration.      Up until now, the application of three-dimensional printing of titanium fixation plates in     jaw surgery has been available only at two centers globally. The published preliminary work     have proved the prospect of customized titanium plates in promoting mandibular reconstruction     surgery and upper maxilla orthognathic surgery though their printed titanium plates looked     rather bulky and the sample sizes were small and there is still lack of qualified randomized     controlled trials between the printed and the conventional titanium plates. To better benefit     from the burgeoning use of three-dimensional printing in health care, it is imperative to     conduct a feasibility study in exploring the application of three-dimensional printing of     titanium fixation plates in jaw surgery based on our patients.      The aim of the study is to conduct a case series study focusing on the feasibility and safety     of applying three-dimensional printed titanium plates in jaw reconstruction surgery and     orthognathic surgery. The outcome measures include the success rate, potential adverse events     and accuracy. A sample size of 48 subjects will be recruited prospectively. Considering the     facts that titanium plates are widely used in jaw surgery and our unit is the largest oral     and maxillofacial surgery center in Hong Kong, the well-designed customized titanium plate is     therefore with great potential benefit for the patients in our population. Furthermore, the     well-developed three-dimensional manufacturing protocol could also be applied in other     relevant medical areas and push forward the personalized medicine era in the future.   "
17444|NCT03057210|"     Introduction: Post-exercise recovery techniques have been extensively investigated in order     to optimize the restoration of various body functions and consequently of performance.     Massage represents approximately 45% of the time spent by a sports physiotherapist in the     field, however, their mechanisms are not well established and studies present divergent     results in the literature.      Objectives: The objective of this study is to analyze and compare the effects of massage when     applied immediately or 1 hour after physical exertion, on functional, clinical and metabolic     variables.      Design: A cross-over randomized clinical trial.      Participants: Forty men aged 18 to 30 years, healthy and that fulfilling the eligibility     criteria.      Procedures: Participants will be randomized into five groups (n = 8 per group): (GA, GB, GC,     GD and GE), which will perform the 5 stages of the study at randomized times, one stage per     session. Stage 1: control; Stage 2: Participants will receive the massage protocol; Stage 3:     physical exercise protocol; Stage 4: Participants will perform the physical exercise protocol     and immediately after, will receive the massage; Stage 5: Participants will perform the     physical exercise protocol and 1 hour after the end of the exercise they will receive the     massage. Sessions will occur with a 1-week interval between them.      Measurements. The primary outcome measures will be measured 2h after the start of each stage,     and the secondary outcome measures will be measured at specific times during each stage. The     primary outcome includes measures of functional performance, and the measures of secondary     outcome includes clinical and metabolic variables.   "
17445|NCT03057197|"     Caudal epidural injections have been commonly performed in patients with low back pain and     radiculopathy. Conventional caudal epidural injections, which the needle is advanced into the     sacral canal, present a potential risk of penetration of the epidural venous plexus or dura.     The investigators hypothesized that a new caudal injection technique, which the needle only     penetrates the sacrococcygeal ligament without being inserted into the sacral canal, might     represent a safe alternative, with a lower incidence of intravascular injections and     patient's discomfort during the procedure than the conventional technique. The study is     designed to investigate the influence of the depth of the inserted needle on successful     epidurogram and clinical outcome in caudal epidural injections under the ultrasound and     digital subtraction angiography.   "
17446|NCT03057184|"     Adult Day Care Centers (ADCC) offer important relief and rest services for family caregivers.     However, some caregivers report that behavioral and psychological symptoms of dementia (BPSD)     arise when they prepare dependents for the ADC, especially when they have dementia. This     issue increases stress for caregivers and contributes to a worsening of their mental health     and quality of life. The present study evaluates the effectiveness of a behavioral     intervention program aimed at reducing the reluctance of the dependent to attend the ADCC. We     hope that reducing resistance will have a positive influence on the mental health of     caregivers.   "
17447|NCT03057171|"     Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which     is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid     tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced     immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key     post-transcriptional regulators of gene expression, differentiation. The investigators had a     preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and     PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced     inflammatory cascade. However, there wasn't a previous study about expression of THRIL, PACER     in a human tissue. Therefore, the investigators aimed to evaluate the expression of THRIL,     PACER in patients with gastrointestinal disease according to H.pylori infection.   "
17448|NCT03057158|"     Millions of women suffer from overactive bladder, and the changes in bladder function affect     their quality of life. The study team believes that it needs to be better understand why     women get overactive bladder in the first place so that better treatments can eventually be     offered.      The purpose of this study is to determine why women with insulin resistance are more likely     to get overactive bladder. Overactive bladder is a type of bladder control problem that can     cause some women to have bladder leakage. This problem is more common in women with diabetes     and pre-diabetes, but it isn't known why.   "
17449|NCT03057145|"     This research study is studying a combination of targeted therapies as a possible treatment     for Advanced Solid Tumors.      The study interventions involved in this study are:        -  LY2606368        -  Olaparib   "
17450|NCT03057132|"     The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™     Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to     caustic body fluids from an ostomy, drain site or fistula.   "
17502|NCT03056456|"     The study will be conducted in participants with type 1 diabetes mellitus to investigate how     the human body processes LY900014, a new blood sugar lowering insulin, and its effect on     blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability     will be documented. The study will last about 4 to 11 weeks for each participant.   "
17454|NCT03057080|"     The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the     management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at     the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive     parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was     performed and a PTA was carried out when feasible during the same session. All patients were     followed until healing, amputation, death, or for at least two years. Short-term and     long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients     with worsening ulcers after PTA underwent bypass grafting or amputation.   "
17455|NCT03057067|"     Results of recent systematic reviews suggest favorable results of embolization for the     treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for     several outcomes, including pain reduction, overall patient satisfaction, and technical     feasibility. Reported complication rates appears relatively low.      Pelvic vein embolization is a relatively new technology and the results may provide     background for an evidence based decision to offer embolization of pelvic varicosities for     women with PCS in Norway.   "
17456|NCT03057054|"     This randomized clinical trial studies how well Lactobacillus plantarum works in preventing     acute graft versus host disease in children undergoing donor stem cell transplant.     Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus     host disease in children, adolescents, and young adults undergoing donor stem cell     transplant.   "
17457|NCT03057041|"     Intranasal fentanyl has been found to be safe and effective in the reduction of pain among     pediatric and adult populations. The investigators hypothesize that patients who receive 100     mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will     report lower pain scores than those who receive placebo. The investigators will test this     hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported     during uterine aspiration between patients who receive either intranasal fentanyl or     intranasal saline prior to the procedure.   "
17458|NCT03057028|"     Pulmonary arterial hypertension (PAH) can result in right ventricular failure and death.     Anakinra has been used in patients with left sided heart failure, and the present study looks     to determine if anakinra is safe and effective in patients with PAH. To accomplish this goal,     we plan to evaluate for exercise improvement (as assessed by cardiopulmonary exercise     testing) in 10 patients with PAH on anakinra.   "
17459|NCT03057015|"     Total knee arthroplasty (knee replacement) is a common orthopedic procedure for     osteoarthritis. This procedure is performed either under general anesthesia or spinal     anesthesia; after the procedure in the recovery room, these patients undergo adductor canal     block, which is a nerve block to provide 8-14 hours of postoperative pain control. For this     nerve block, 15-20 ml of local anesthetic is combined with adjuvant medications to improve     the quality of pain control as well as the duration of pain relief. The primary local     anesthetic used for adductor canal block is ropivacaine, and the commonly used adjuvants are     epinephrine and dexamethasone.      There is conflicting data available in the literature regarding efficacy of addition of     clonidine to the local anesthetic injection in peripheral nerve blocks, and there is no data     assessing the efficacy of this medication in adductor canal blocks.      Once the consent process is completed, patients are enrolled in two arms. Upon conclusion of     surgery, a sealed and coded envelope with either clonidine or the placebo syringe will be     given to the acute pain service staff performing the nerve block. This will be mixed with     local anesthetic solution and injected in the adductor canal under ultrasound guidance.      The primary outcome measure will be the duration of analgesia, which will be assessed as the     time interval between placement of adductor canal block to the first request of opioid     analgesic by patients (which will be obtained from hospital electronic medical records).     Secondary outcomes will include:        1. Duration of sensory block, which will be assessed as the time interval between injection          of local anesthetic and report of postoperative pain of 3 or more on an 11 point scale          (0=no pain; 10= worst pain imaginable) by the patient (this will be assessed every 4          hours).        2. Duration of motor block, which will be assessed as the time interval between the onset          of motor block to complete recovery of motor block by assessing straight leg raise          strength (this will be assessed every 4 hours).        3. Cumulative 24 and 48 hour opioid analgesic use.        4. Post-block pain scores, evaluated by an 11 point pain score (0-10), which will be done          every 15 minutes for the first hour after surgery and every 4 hours thereafter for 24          hours.   "
17460|NCT03057002|"     In this study the investigators propose to detect early mitochondrial metabolic changes in     the heart in patients with a positive genotype and phenotype for Hypertrophic Cardiomyopathy     (HCM) using a novel hyperpolarized [1-13C]pyruvate Magnetic Resonance Imaging (MRI)     methodology.   "
17461|NCT03056989|"     Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult     subjects with cystic fibrosis.   "
17462|NCT03056976|"     The aim of this study is to assess the cost-effectiveness of the mandibular overdenture     retained by one and two implants and the mandibular fixed prosthesis retained by four     implants, based on a randomized clinical trial.   "
17463|NCT03056963|"     The purpose of this study is to examine the efficacy of a guided imagery paradigm for     reducing negative ways of thinking about the self. There will be at least 60 participants     enrolled at the University of Texas at Austin. Participants will be randomly selected to     receive one of two types of trainings, each over the course of two weeks. Participants will     undergo the training exercises at home. The training exercises will help them to think     differently about themselves.      Participants will be able to determine if they are eligible, and then participate, by filling     out a screening questionnaire online.   "
17464|NCT03056950|"     Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads     to beneficial changes in muscle strength at low resistance and minimal stress on the nearby     joint. This novel resistance training has the potential to greatly improve muscle strength     gains in individuals who are unable, for medical reasons, to perform the high resistance     exercises typically required to improve strength. Our study will examine the effect of this     technique on strength recovery following distal radius fracture treated with cast     immobilization (non-operatively). The primary objective of the intervention is to achieve     accelerated recovery of forearm, wrist and hand function as assessed using measures such as     grip/pinch strength, validated questionnaires, and functional outcome testing. Occlusion     training can potentially serve as a specialty intervention for rehabilitation patients,     reduce the cost of care, and improve the treatment options for both patients and providers.   "
17465|NCT03056937|"     The hypothesis of this study is that reductions in body weight could improve inspiratory     muscle function attenuating the inspiratory metaboreflex in metabolically healthy obese     individuals and obese individuals with metabolic syndrome.   "
17503|NCT03056443|"     The study aimed to examine the effect of Continuous Positive Airway Pressure (CPAP)     initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure     patients on reducing 30-day hospital readmission rate through a clinical trial.   "
17504|NCT03056430|"     The purpose of this study is to determine whether intensive slackline training improves     spatial orientation abilities, balancing skills and causes neuroplasticity in related brain     cortical regions.   "
17466|NCT03056924|"     Patients with Crohn's disease (CD) and ulcerative colitis (UC) are often treated with     medications that suppress the immune system. These patients are therefore at increased risk     for developing infections, such as influenza, pneumonia, and hepatitis B, which may be     prevented by vaccination. While awareness is increasing among gastroenterologists of the     importance of vaccinations in the IBD patient, there continues to be some question of the     effectiveness of vaccination in immunosuppressed patients. It has been previously shown that     patients on immunosuppressive therapy with certain biologic medications (the TNF-blockers:     infliximab and adalimumab) had an impaired immune response to vaccination as compared to     healthy controls, as the mechanism of immunosuppression for these agents is systemic.     Vedolizumab, a biologic medication for CD and UC approved in May 2014, targets the α4β7     integrin, a key component of gut immunity, and as such it has been hypothesized that with     this agent effects are gut specific. There is limited data that suggests that in healthy     patients given vedolizumab do not have an altered response to parentally administered     vaccines, however there are no studies in the CD and UC population describing this.     Additionally, IBD patients treated with vedolizumab are frequently also on concomitant     therapy with an immunomodulator (6-mercaptopurine, azathioprine, or methotrexate), and these     patients ability to mount an immune response has not been demonstrated.   "
17467|NCT03056911|"     The aim of the study is to evaluate the clinical effects of Ozone-oxygen therapy as     therapeutic substance for nucleolysis application in the patients with cervical disc hernia     who had chronic pain and weakness on the neck, shoulders and arms   "
17468|NCT03056898|"     Health professionals attending the American Association for Family Physicians (AAFP) meeting     at the Orlando Convention Center, Sept 21-23, 2016 who visit the DSM Nutritional Products Inc     booth will be invited to complete an omega-3 dietary intake survey and have a drop of blood     taken by finger stick by a health professional for blood fatty acid analysis. Dried blood     samples on filter paper will be sent to an outside laboratory (OmegaQuant LLC) for analysis.     Within 2 weeks, participants will receive an Omega-3 Index Test report by email from     OmegaQuant LLC. After removing personal information, OmegaQuant LLC will share blood fatty     acid and omega-3 dietary intake results with the sponsor.   "
17469|NCT03056885|"     This study evaluates the local cytokine inflammatory response during one lung ventilation in     patients undergoing pulmonary lobectomy or wedge resection. We compare two different     ventilation strategies: a conventional strategy with a protective strategy.   "
17484|NCT03056690|"     The purpose of this study is to assess analgesic efficacy of ASP0819 relative to placebo as     well as the safety and tolerability.      This study will also assess treatment differences in physical function as well as the     improvements in overall subject status (e.g., fibromyalgia symptoms and global functioning)     of ASP0819 relative to placebo.   "
17470|NCT03056872|"     Alcohol dependence is among the most common and costly public health problems affecting the     nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a     co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months     following AUD treatment. Dysregulation of biological stress-mood systems predict and     correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation     correlates with improved AUD treatment outcomes but has not been examined with respect to AUD     recovery and relapse in co-occurring AUD+AnxD.   "
17471|NCT03056859|"     This is a single-arm observational trial of a device (Compass Vascular Access, Centurion     Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular     blood pressure transducer. This pressure measurement aids in confirmation of appropriate     venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who     require central venous catheterization for clinical reasons independent of the existence of     this study. The primary outcome is operator satisfaction.   "
17472|NCT03056846|"     The purpose of this research study is to evaluate the effect of a daily supplement of     probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum     MM-2) on stress-associated gastrointestinal function in university students during the time     of semester exams.   "
17473|NCT03056833|"     Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance     the response to platinum-based therapy and maintenance therapy will slow ovarian cancer tumor     growth leading to prolongation in progression free survival.   "
17474|NCT03056820|"     The purpose of this study is to compare the effect of the 25° head-up position versus the 55°     head-up position on tolerable apnea time (TAT) after induction of general anesthesia in     patients with a body mass index (BMI) of 30-40.   "
17475|NCT03056807|"     The purpose of this study is to compare the effect of the 25° head-up position versus the 55°     head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for     laparoscopic adjustable gastric band surgery following maximum preoxygenation and     rapid-sequence induction (RSI) of anesthesia.   "
17476|NCT03056794|"     Children and adults with pyruvate dehydrogenase complex (PDC) deficiency are participating in     a research study seeking to better understand the genetic causes, symptoms, usefulness of     current treatments, and outcomes for these disorders. The research project involves     completing a questionnaire about the individual or family's medical history and experiences     with PDC deficiency, review of medical records by the researchers, and in some cases,     advanced genetic testing. A blood draw will be requested, and an optional skin biopsy is part     of the study for some participants.   "
17525|NCT03056157|"     The aim of this study is to determine the efficacy of Adaptive Disclosure for Moral Injury     and Loss (AD-MIL), a combat-specific psychotherapy for war-related PTSD stemming from Moral     Injury (MI) and traumatic loss (TL) with Iraq and Afghanistan War Veterans with PTSD. AD-MIL     will be compared to Present Centered Therapy (PCT). AD-MIL is a modified version of Adaptive     Disclosure (AD), which has been modified and extended to solely treat MI and TL by targeting     psychological and behavioral obstacles to occupational, relationship, and family functioning,     as well as quality of life. PCT is a manualized evidenced-based PTSD treatment used in     several large-scale PTSD trials. The primary end-point is psychosocial functioning     (improvements in social, educational and occupational functions and improvements in quality     of life). Secondary end-points include PTSD, depression, and shame and guilt. The     investigators will also explore the impact of AD-MIL on anger and aggressive behaviors,     suicidal ideation, and alcohol abuse.   "
17477|NCT03056781|"     The purpose of this research is to understand how the emotions of people with different     mental health concerns (e.g., people with schizophrenia, people with major depressive     disorder) differ from individuals without mental health concerns. A large body of literature     suggests that people with mental illnesses have emotional abnormalities compared to healthy     individuals, but a number of these abnormalities are not well understood. For example, often     people with schizophrenia report on questionnaires that they experience fewer pleasant     emotions when talking with other people, but some evidence suggests these individuals report     a similar amount of pleasant emotion when they are actually engaged in a pleasant activity.     Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more     real-world setting. In the tasks in the current proposal, participants will engage in a     series of tasks designed to assess their emotional functioning. These tasks involve viewing     emotional stimuli on the computer, engaging in social interactions, and consuming small     amounts of food. In all tasks, participants will make ratings of their experiences of     pleasure (and displeasure). We will then compare the experiences of patient groups to those     of healthy individuals to test how emotional ratings might differ across these tasks.   "
17478|NCT03056768|"     Objectives: 1-year multidomain health promotion on prevention of physical and cognitive     decline for community-living older people.      Design:      Methods: Randomized controlled trial      Setting:      Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or     older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health     promotion (physical, cognitive, nutritional intervention)      Measurements:      Primary outcome includes frailty status and cognitive performance. Secondary outcomes include     depressive symptoms, nutrition assessment, and functional capacity; All the variables were     measured at 0, 6, 12 months. The effect of intervention was investigated by     intention-to-treat analysis.   "
17480|NCT03056742|"     This study is being conducted as an extension of the phase II clinical trial     SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued     clinical study in consultation with ICMR, as per recommendation of Cellular biology based     therapeutic drug evaluation committee (CBBTDEC).   "
17481|NCT03056729|"     The primary objective of the study is to evaluate the safety and tolerability of     single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants     with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers     and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076     after single-dose administration. Another secondary objective is to evaluate the     immunogenicity of BIIB076 in serum after single-dose administration.   "
17482|NCT03056716|"     In thoracic surgery, it is usual to place apical and basal drains for complete drainage of     air and fluid out of the pleural cavity. The routinely used drains are mainly made of     plastic. Recently silastic drains of smaller size are used without any complication. The     investigators designed a prospective randomized trial to compare the draining properties of     the two types of drains following various resections in thoracic surgery.   "
17483|NCT03056703|"     The primary objective of this study is to compare the bioavailability of a single dose of a     new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a     commercially available 500 mg fast release tablet and to test for bioequivalence of the new     versus the commercial product in healthy adult subjects.   "
17485|NCT03056677|"     After meals, the level of glucose rises in the circulation. In some individuals who are     overweight and older, blood glucose can rise to levels which can damage tissues and cause     health problems. Usually the hormone insulin, released from the pancreas, effectively lowers     blood glucose. However, in overweight and older people insulin is less effective. Certain     foods can lower the rise in blood glucose, particularly proteins. This works by increasing     the release of a hormone from the gut called Glucagon-Like Peptide 1 (GLP-1), which in turn     increases the release of insulin. A Component of milk left over after cheese making, termed     Whey protein, is particularly good at releasing GLP-1. Whey protein is used as a food     additive and taken as a supplement to help build muscle. Whey protein is a mixture of     proteins which the investigators have modified to be more effective at lowering blood     glucose. Using laboratory tests the investigators identified a protein present in Whey that     does not increase levels of GLP-1 and removed it. It's removal raises the levels of other     proteins which are more effective. In this study, the investigators would like to test the     effectiveness of the modified whey protein. To do this, 30 older, overweight volunteers     will be recruited and given the modified whey protein, a normal whey protein or a mixture of     amino acids and then a breakfast meal to raise their blood glucose levels. These drinks will     be given in a randomised sequence 1 week apart. On each visit, blood samples to measure blood     glucose and related hormone levels will be taken. As GLP-1 can also have an effect on     appetite, the investigators will measure the effect of the modified whey protein on     subsequent appetite in the volunteers by asking them how hungry they feel.   "
17486|NCT03056664|"     Here investigators will carry out this phase II clinical trial to explore a effective     therapeutic regimen of MSC in the Crohn's perianal fistula.   "
17487|NCT03056651|"     The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an observational     study on selected patients with advanced refractory heart failure. The purpose of the study     was to examine the comprehensive management of HF in the day-care unit in terms of the safety     and its impact on the rehospitalization and mortality rates in patients with advanced     refractory HF.   "
17548|NCT03055845|"     A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to     investigate the safety, local tolerability and transformation of nucleus pulposus following     intradiscal injection of STA363 or placebo in patients with discogenic low back pain.      15 patients will participate in either of 3 dose groups, each comprising 5 patients:        -  Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)        -  Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)        -  Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)   "
17549|NCT03055819|"     The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a     browlift for patients with age-related brow ptosis. It is a single arm, open label     multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20     subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used     to confirm the device safety and efficacy and provide inputs to further refine the device     design and procedure technique for future device iterations   "
17488|NCT03056638|"     Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that     allows the physician to deliver more radiation dose in a single session. Because of this, the     number of radiation sessions can be reduced from the typical 45-48 sessions, as in     conventional daily session radiation, to 5 sessions given every other day over a week and a     half. Giving the radiation at a higher dose during each treatment may be more effective in     killing the prostate cancer cells than the standard way of using external radiation therapy     where a small amount of radiation is given over many sessions.      Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat     intermediate risk prostate cancer. This therapy works by reducing the level of testosterone     and stopping them from affecting your cancer. The ADT used in this study is known as     Degarelix. Degarelix is an approved medication that reduces the body's production of     testosterone; this medication is usually given to all men with intermediate risk prostate     cancer getting external radiation.      This study is a randomized study to find out whether combining stereotactic (also known as     precision) radiation to the prostate cancer combined with a short course of Degarelix will     result in a greater likelihood of killing the cancer in the prostate compared to stereotactic     radiation therapy given alone. It has been shown that the combination of radiation with     medications that interfere with testosterone production and its effects makes prostate cancer     cells more sensitive to the radiation.   "
17489|NCT03056625|"     Vitamin A deficiency (VAD) remains a public health problem that occurs in children and women.     WHO estimates that 190 million preschool age children (under five years of age) and 19.1     million pregnant women have inadequate concentrations of retinol . VAD may increase risk of     morbidity and mortality during childhood, pregnancy and postpartum period . In developing     countries, vitamin A status in lactating women is not optimal. Even in the United States,     vitamin A status of low income pregnant women is marginal. Therefore, women of reproductive     age are at risk of vitamin A depletion which compromises the vitamin A status of breastfed     infants. Vitamin A is transferred to milk from both retinol binding protein bound and     chylomicron associated vitamin A carriers. Because of teratogenicity of vitamin A, the     transfer of vitamin A from pregnant mother to the fetus is carefully controlled. This results     in all infants born with very low stores of vitamin A . Therefore human milk is still the     best vitamin A source for infants. The concentration of vitamin A in breast milk is highest     in the first 21 days postpartum (colostrum in the first 4-6 days and transitional milk in the     next 7-21 days). Breast milk vitamin A concentrations and an infant's vitamin A status are     based on maternal dietary intake. Breast milk retinol concentrations are a useful tool and a     unique indicator for lactating women and represents extrapolations of vitamin A status of     breastfed infant.      In high risk vitamin A deficiency areas, prior recommendation for lactating women was to give     two doses of 200,000 IU vitamin A within 6 weeks post-delivery . However, the lack of impact     evidence of this regimen led to the WHO's withdrawal of such recommendation as a public     health policy .      Food-based intervention has been regarded as a sustainable approach to improve population     vitamin A status. Most recently, vitamin A-depleted sows fed high-provitamin A carotenoid     maize resulted in significant increase in liver stores in nursing piglets and significant     higher milk retinol concentrations than sows fed white maize that given a high-dose vitamin A     supplement .      Previous efforts to fortify staples or common vehicles with vitamin A offer promising     solution to prevention of vitamin A deficiency in vulnerable population . Food fortified with     vitamin A has potentials to improve women's vitamin A status and to increase the vitamin A     concentrations of breast milk . Rice as the most important staple food in Thailand,     represents the culture of consumption and lifestyle of Thai people . Recent study in Thai     school children fed with extruded rice grains fortified with zinc, iron and vitamin A every     weekday for 2 months, significantly increased liver stores of vitamin A, as assessed with a     stable isotope technique . Likewise, fortification of rice with vitamin A may also benefit     mothers during lactation.      The outcomes of this study will be useful to guide the promotion of food-based strategies to     improve vitamin A status of mother and infant during lactation.   "
17490|NCT03056612|"     The aim of this study is to assess prospectively the critical period prior to the development     of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological     processes associated with the development and clinical course of ACLF (2) and to identify the     precipitating events of ACLF (3).   "
17491|NCT03056599|"     This is a feasibility study in patients with localized or metastatic soft tissue sarcoma     undergoing surgery to determine how sarcoma in situ responds to injected microdoses of     anti-cancer therapeutics.   "
17492|NCT03056586|"     Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or     cystocele or rectocele, or mixed. About half of them will require surgical repair for the     prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence     of the prolapse, which in some cases requires second operation.      In this study the investigators want to investigate whether a vaginal pessary inserting in     the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.   "
17493|NCT03056573|"     Expand the indication of the Portico TF Delivery System and obtain approval of the     Alternative Access Delivery System   "
17494|NCT03056560|"     This study will evaluate an innovative video bystander program, which has the potential to be     implemented broadly and cost-effectively across college campuses. Half of the participants     will receive the video bystander program, and the other half will not.   "
17498|NCT03056508|"     This study will explore the impact of an exercise and nutrition (EX+NUTR) , relative to     exercise alone (EX) intervention, on brain structure and function as well as blood biomarkers     in older adults with subjective cognitive decline (SCD) and vascular risk factors. The     overall hypotheses are that a combined EX+NUTR, relative to EX, intervention will evoke more     positive changes in brain structure (e.g. hippocampal volume), neural activity (e.g. task     associated functional activations monitored through fMRI), and cognitive performance. These     changes will be associated with an improved metabolic profile, reductions in inflammatory     cytokines and oxidative burden, and greater intervention compliance.   "
17499|NCT03056495|"     This Clinical Trial is an open, non-randomized Phase Ib study to determine the maximal     tolerable dose (MTD) of Vorinostat in Alzheimer disease (AD) patients between (including) 55     and 90 years with mild symptoms. The MTD in this study is defined as the dose that leads to     maximum toxicity with Common Toxicity Criteria (CTC) grade 1 symptoms.The safety and     tolerability of Vorinostat in this group of study participants should be tested.   "
17500|NCT03056482|"     Cannabis Hyperemesis Syndrome (CHS) has become a well-documented syndrome since 2004 and is     expected to increase in prevalence with continuing liberalization of marijuana and     recognition of the disease. Regardless of whether the association with heavy cannabis use is     recognized, there is well-documented resistance to traditional anti-emetic treatment. Given     promising reports of the use of intravenous haloperidol, a randomized controlled trial     comparing it to the commonly administered anti-emetic ondansetron will contribute to the     management of CHS   "
17501|NCT03056469|"     This study investigates if integration of patient-reported outcomes in the follow-up of     patients with newly diagnosed, not curable, chronic hematological cancer changes the number     and kind of supportive care interventions. Furthermore, this study investigates if the     patients feel that they are more involved in a positive way when patient-reported outcomes     are integrated in the follow-up of their cancer.   "
17505|NCT03056417|"     The current project will use the Complete Health Improvement Program (CHIP) as an     intervention for patients with chronic pain. CHIP is a nationally recognized program that     encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social     support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared     to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that     patients who complete CHIP will have increased telomerase activity and longer relative     telomere length at follow-up when compared to those who do not enroll in the program.     Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres     are the caps on these chromosomes that protect them from damage. Telomere shortening occurs     normally with aging and once they are too short to replicate cellular death occurs.     Telomerase is a ribonucleic protein that counterbalances this shortening by extending the     ends of chromosomes. Research has shown that patients with chronic pain may have shorter     telomeres relative to others of the same age. This study will investigate this association     further.   "
17506|NCT03056404|"     This study aims at identifying bird proteins useful for diagnostic tests to determine the     cause of Bird Fancier's Lung (BFL).   "
17507|NCT03056391|"     Acute kidney injury is a common complication of severe Plasmodium knowlesi malaria, and an     important contributor to mortality.      The exact pathogenic mechanisms of AKI in knowlesi malaria are not known, however it is     hypothesised that haemolysis of red blood cells and subsequent release of cell-free     haemoglobin leads to oxidative stress and lipid peroxidation in the renal tubules.      A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol acts as     a potent inhibitor of hemoprotein-catalyzed lipid peroxidation. In a proof of concept trial,     paracetamol at therapeutic levels was shown to significantly decrease oxidative kidney injury     and improve renal function by inhibiting the hemoprotein-catalyzed lipid peroxidation in a     rat model of rhabdomyolysis-induced renal injury.      The investigators hypothesize that this novel inhibitory mechanism of paracetamol may provide     renal protection in adults with knowlesi malaria by reducing the hemoprotein-induced lipid     peroxidation that occurs in haemolytic conditions. As there is currently no consensus that     exists concerning adequate medical treatment for severe malaria complicated by intravascular     haemolysis and AKI, the potential application of paracetamol would be of benefit, especially     as it is safe and widely available.   "
17508|NCT03056378|"     The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared     to standard leukoreduced RBC products stored in additive solution. The primary objective is     to determine if there is no significant difference in transfusion associated adverse events     in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are     no significant differences in new antibody and new positive direct antiglobulin test (DAT)     formation in the POOLED-RBCs compared to standard RBC product groups.   "
17509|NCT03056365|"     The SAMBA study aims to assess the safety and cost comparison of the management of outpatient     alcohol detoxification, between an advanced nurse protocol on the one hand (experimental     group), and a GP-based treatment on the other hand (standard-of-care group).      In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol     based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores,     which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In     case of any serious adverse event or uncontrolled withdrawal complication, an addiction     specialist stands in back-up and can be appealed to decide whether the outpatient detox can     be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage     patients as they wish.   "
17511|NCT03056339|"     The goal of this clinical research study is to learn if giving genetically changed immune     cells, called NK cells, after chemotherapy will improve the disease in stem cell transplant     patients with relapsed (has returned) and/or refractory (has not responded to treatment)     B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable dose of     CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia. The     safety of this treatment will also be studied.   "
17512|NCT03056326|"     Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic     lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable     inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed     to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in     healthy male subjects.      The study will comprise two parts:      Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety,     tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.      Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety,     tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333   "
17513|NCT03056313|"     The duration of labor is decisive for maternal and fetal health. Poor progression often     results in tired mothers, bad experience, delivery complications and a demand for cesarean     section in next pregnancy. Proactive support of labor is a method originally from the     Netherlands.      The main idea is to define start of active labor earlier than the traditional 3-4 cm opening     of the cervix and regular contractions to be cervix < 0.5 cm in length, and 1 cm opening and     painful contractions. From this point, it is expected to be a progress of 1cm/hour opening of     cervix. If not, progress is supported by amniotomy or stimulation of contractions.      This method is embraced by several clinics with great enthusiasm. However, there are no     randomized controlled trials to prove that this method is better than others.   "
17514|NCT03056300|"     The primary objective of this trial is to demonstrate the effectiveness of the powered     vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during     Video-Assisted Thoracoscopic Lobectomy.   "
17577|NCT03055442|"     Considering the importance assumed by follicular microenvironment for a proper oocyte     development, this study is a prospective observational clinical trial which aims to evaluate     whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and     D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study     includes egg donors and egg receiving couples participating in the oocyte donation program.     MI/DCI is calculated in FF and related with blastocyst grade.   "
20147|NCT03021850|"     The purpose of this study is to compare the acute effect of the use of different thermal     modalities associated to the training of passive flexibility of the hamstring muscles in the     amplitude of motion of the knee extension.   "
17515|NCT03056287|"     This project will assess the effects of aerobic exercise training (AET), repetitive     transcranial magnetic stimulation (rTMS) or their combination on depressive severity as well     as locomotor function in persons with post-stroke depression (PSD). Both AET and rTMS are     established stand-alone treatments for non-stroke related depression, though neither has been     adequately studied post-stroke. Furthermore, substantive research indicates that AET improves     post-stroke locomotor function, thus offering a novel approach for treating PSD as well as an     established vehicle to study the effects of PSD on response to rehabilitation.      The purpose of this project is to determine the impact of AET, rTMS and their combination     (AET+rTMS) treatments on post-stroke depressive symptoms and locomotor function so as to     guide the development of a future clinical trial. A total of 40 depressed post-stroke     subjects will be randomly assigned to one of four groups 1) AET; 2) rTMS; 3) combined AET and     rTMS (AET+rTMS) or 4) control (sham rTMS) group (n=10 per condition; equally distributed with     mild and moderate MDD). Further, an additional 10 non-depressed post-stroke subjects will     complete 8 weeks of AET so as to allow us to determine the effects of PSD on response to     training (Aim 2). Training (AET, rTMS and AET+rTMS) will take place over an 8-week period,     three times per week on non-consecutive days. Measures of depression (HRSD17) as well as     self-selected walking speed (SSWS) will be performed prior to the initial treatment session     of each week as well as 8 weeks following cessation of treatment. Additional measures of     locomotor function (walking endurance and amount of daily community stepping) will be     assessed prior to training (pre), following 4 weeks of training (mid), upon completion of 8     weeks of training (post) as well as 8 weeks following cessation of training (follow-up),     allowing determination of the efficacy (and persistence) of training on these outcomes.   "
17516|NCT03056274|"     This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid     in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS     hospital sites, over an 18 month period.   "
17517|NCT03056261|"     Sixty neonates and infants will be enrolled and randomised into two groups of n=30 each . For     their surgical procedures, one group general (GA) anaesthesia the second group will receive a     combined general and epidural anaesthesia (CGEA).      Anaesthetic technique:      Patients in the GA group will be induced with intravenous propofol (2-4 mg.kg-1) and fentanyl     (2-4 µg.kg-1) and will receive rocuronium bromide (0.5 mg.kg-1) to facilitate endotracheal     intubation. Anaesthesia will be maintained with sevoflurane (2-3%) in an air/oxygen mixture     as well as intravenous fentanyl as required.      In the (CGEA) 0.5 ml.kg-1 of 0.25% bupivacaine will be injected into the epidural catheter,     followed by a continuous infusion of 0.1% bupivacaine at a rate of 0.2 mg.kg-1.hr-1 for up to     48 hours postoperatively. Assessment of anaesthetic efficacy will be measured Intraoperative     care vital signs. And will continuously be monitored with a Datex AS/3 (Engestrom®, Helsinki,     Finland) monitor.      The use of antibiotic prophylaxis will be determined by the degree of bowel contamination     during surgery, with the commonest regimen consisting of penicillin, gentamicin and     metronidazole will be administered. Antibiotics will be continued for 36-48 hours     postoperatively to prevent infection arising from the disturbed bowel flora.      Postoperative care, following surgery, will be conducted. The feeding volume will be     increased in steps as long as the volume of regurgitated fluid will be less than 20% of the     administered breast milk or formula volume. Full feeding will define as oral tolerance of at     least 80% of daily maintenance volume. In cases of abdominal distension or vomiting, feeding     will withheld until symptom resolution. The nasogastric tube will be removed on bowel     function restoration The CRIES score will be use to assess the severity and duration of     postoperative pain during the patients' NICU stay. If the CRIES score is ≥4, fentanyl will be     continuously intravenously infused in both study group. Fentanyl will be also administered to     CGEA patients who experienced pain despite a continuous epidural infusion at 1-5 µg.kg-1.h-1.     The amount of fentanyl required for adequate postoperative pain relief will be recorded in     both groups.   "
17518|NCT03056248|"     A growing body of pre-clinical evidence suggests that glycogen synthase kinase 3β (GSKβ) is     implicated in the development and progression of acute kidney injury (AKI). Lithium is a     naturally occurring standard inhibitor of GSKβ. The purpose of this study is to examined if     low dose lithium carbonate is able to reduce the incidence of AKI in patients undergoing     cardiac surgery who are placed on cardiopulmonary bypass during surgery. We hypothesize that     low dose lithium might reduce the incidence and duration of AKI in patients undergoing     cardiac surgery who are on cardiopulmonary bypass.   "
17519|NCT03056235|"     The study is designed to evaluate the efficacy of two formulations of a cross-linked     tropoelastin matrix given the product codes ELAPR002f and ELAPR002g (collectively referred to     as ELAPR or ELAPR002) for the treatment of rolling atrophic acne scars when administered as     intradermal implants.   "
17520|NCT03056222|"     The aim of the study is to compare the acute procedure and safety outcomes as well as long     term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically     Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated     Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D     Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).   "
17521|NCT03056209|"     The purpose of this First In Human study is to investigate the safety and tolerability of     KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of     KL1333 after a single oral dose.   "
17522|NCT03056196|"     Introduction      Undiagnosed deep vein thrombosis (DVT) can lead to significant morbidity and mortality,     including death from DVT-associated massive pulmonary embolism (PE). While several validated     clinical prediction rules, blood test and imaging modalities exist to investigate a potential     DVT, there is currently a lack of rapid, accessible and reliable methods to exclude the     possibility of DVT without resorting to formal venous duplex scanning.      Currently, the use in the ED of a validated clinical prediction rule combined with     high-sensitivity D-dimer test has a poor predictive value, as 75-90% of patients suspected of     DVT have a negative formal venous duplex scan.      Compression bedside ultrasound has however recently been shown to be a safe, rapid and     accurate method for the diagnosis of proximal DVT in the emergency department with a high     sensitivity and specificity (combined sensitivity and specificity of 96.1% and 96.8%,     respectively1).      Research Question      In the present study, the investigators will primarily assess whether two-site compression     POCUS combined with a negative age-adjusted D-dimer test can accurately rule out DVT in ED     patients regardless of the Wells criteria.      Methods      This is a single-center, prospective, observational study carried out over one year in the     Emergency Department of the Jewish General Hospital in Montreal, Quebec. The investigators     aim to enroll a convenience sample of 475 patients aged 18 years and older presenting to the     ED with symptoms suggestive of a DVT. All enrolled patients will receive the standard of care     required for a lower leg DVT presentation. After calculating Patients DVT risk using modified     wells criteria, all patients will undergo POCUS for DVT followed by a D-dimer test. Based on     their results, patients will either undergo formal duplex scanning, or will be discharged     without further testing and receive a three-month phone follow-up.      A true negative lower leg DVT will be defined as follows:        1. Negative follow-up phone questionnaire for patients who were sent home with no formal          duplex venous scanning.        2. Negative formal duplex venous scanning for patients who were deemed likely to have lower          leg DVT using the Wells score, with a negative D-dimer and POCUS      Age-adjusted DVT was added to account for below knee DVT and avoid the need for patients to     return for fellow up duplex study in 1 week.      To estimate our technique's sensitivity with a 4% margin of error with 95% confidence     intervals, 92 confirmed DVT patients are needed. The investigators expect to recruit a total     475 patients within one-year period at the JGH (95 DVT-positive patients and 380 DVT-negative     patients).      Impact      The use of compression bedside ultrasound with a negative age-adjusted D-dimer test to rule     out DVT in the ED may accelerate the decision regarding patient disposition and significantly     decrease the length of patient stay in the ED. In addition, it may help avoid unnecessary     medical interventions and diagnostic tests, thus representing potential quality of care and     cost-saving improvements as well.   "
17523|NCT03056183|"     Aim 1: To collect data on a Depression Care Transition (DCT) program's association with     self-care behaviors as measured by medication adherence and clinic visit attendance, after     discharge. Hypothesis 1: Compared with usual care, patients who receive the DCT intervention     will have significantly greater medication adherence and clinic visit attendance, at 30, 90,     and 365 days after discharge.      Aim 2: To collect data on DCT's association with clinical/health outcomes as measured by     depression severity, functional status, and overall physical and mental health, after     discharge. Hypothesis 2: Compared with usual care, patients who receive the DCT intervention     will have significantly larger improvements in depression severity, functional status, and     overall physical & mental health at 30, 90, and 365 days after discharge.      Aim 3: To collect data on DCT's association with utilization outcomes as measured by     readmissions, length of subsequent hospital stays, and cost of care, after discharge.     Hypothesis 3: Compared with usual care, patients who receive the DCT intervention will have     significantly lower hospital readmissions, shortened length of subsequent hospital stays and     lower cost of care, at 30, 90, and 365 days of discharge.      Leading the research team are a psychiatrist (Dr. IsHak - PI) and a hospitalist (Dr. Nuckols     - Co-I) with an advanced and well-established track record of health services     research/scholarship in the fields of depression, outcome measurement, and economic     implications of improving the quality and safety of health care.   "
17524|NCT03056170|"     tDCS is a technique emerging as a prospective therapy for neurologic, psychiatric and     addictive disorders. Specifically, fronto-temporal tDCS, with anodal stimulation over the     left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the left     temporo-parietal junction (TPJ), has been reported to reduce treatment-resistant auditory     hallucinations (AH), negative symptoms and insight of the illness in schizophrenia. However,     despite an increasing use in clinical settings, tDCS suffers from limitations, especially     regarding the strength and the duration of therapeutic effects.      Some imaging reports suggest that tDCS effects are not restricted to the brain areas located     under the electrodes, but spread through distributed cortical networks functionally connected     with the targets and reach subcortical areas. Overall, these studies suggest that tDCS     modulates functional connectivity within and across resting-state networks and brain     activity. However, these effects are currently described at different levels depending on the     imaging technique used. Moreover, the majority of studies have focused on motor cortex     stimulation, while the specific effects of fronto-temporal tDCS are scarce. Finally, effects     of the stimulation applied online are rarely inspected.      According to the therapeutic effects of fronto-temporal tDCS on schizophrenia and the     dopaminergic pathophysiological hypothesis of schizophrenia, the effect of fronto-temporal     tDCS on dopaminergic transmission is of major interest. As the cortex is densely connected     with basal ganglia areas, tDCS effects are probably capable to reach subcortical dopaminergic     areas. Indeed, recent fMRI studies highlighted subcortical effects of tDCS applied at the     cortical level including modulations of cortico-striatal and thalamo-cortical functional     connectivity. In addition, some studies suggest that cortical stimulation by other     approaches, such as transcranial magnetic stimulation (rTMS) modulates dopaminergic     transmission. However, tDCS effects on dopaminergic transmission have been investigated only     indirectly.      Finally, information about biological effects of tDCS is scattered and creating a coherent     ensemble is a mandatory and critical step to understand the mechanisms of action of tDCS.      According to the hypothesis that fronto-temporal tDCS modulates brain activity, connectivity     and dopaminergic transmission, the aim of this project is to reveal the combined     neurobiological impact of an online single session of fronto-temporal tDCS in a unique     experiment by developing a simultaneous multimodal imaging approach (PET-MRI). The online     implementation of the stimulation will allow deciphering changes induced during and after     stimulation. As a first step before investigating patients with schizophrenia, healthy     subjects will be involved in the present study.      The distributed changes will be explored at rest through:        -  Spontaneous functional connectivity assessed by functional magnetic resonance imagery          (fMRI).        -  Brain activity assessed by cerebral blood flow quantitatively and directly measured by          arterial spin labelling (ASL).        -  Connectivity assessed by diffusion tensor imaging (DTI).        -  Specific and localized dopaminergic transmission evaluated by positron emission          tomography (PET) using dopaminergic D2 subtype receptor availability via [11C]raclopride          binding.      The pioneering aspects of the project are to use an innovative simultaneous multimodal     imaging system, adopt the tDCS montage used in our validated therapeutic context and apply     tDCS online. We expect that our unique approach will provide an imaging biomarker essential     to improve our understanding of:        1. the normal brain and further deficient mechanisms underlying schizophrenia as well as          neurological disorders.        2. neurobiological effects of tDCS in order to:             -  Bring key element of the proof of concept of tDCS             -  Optimize tDCS in a therapeutic context             -  Suggest a marker of the therapeutic response   "
17550|NCT03055806|"     A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the     effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with     lifelong PE.      Men with self-reported lifelong PE (International Society for Sexual Medicine (ISSM)     definition) and in stable heterosexual relationship will undergo a 4-week run-in period     during which they will be asked to attempt intercourse at least 4 times. Men with IELT ≤ 1     minute on at least 75% of attempts at intercourse during the no-treatment run-in period will     be randomized for the double-blind phase of the study.      In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours     prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of     8 times during the 8 week double-blind study treatment. The patient or partner will record     the IELT on each occasion by use of a stopwatch.   "
17526|NCT03056144|"     Spinal muscular atrophy (SMA) are one of the common physical disabilities in childhood. For     SMA, progressive muscle weakness and early fatigue hamper the mobility of the sufferers.     Osteopenia is common for this population group due to poor bone growth and muscle disuse. As     a result, non-traumatic related fractures and bone pain are common. Recently, whole body     vibration therapy (WBVT) has been proven to improve bone health and muscle function in     healthy adults and post-menopausal women. Among the limited studies on the WBVT for children     with muscular dystrophies, promising results have been shown on gross motor function,     balance, and muscle strength and the WBVT appears to be safe for children with SMA.      The present pilot study is designed to investigate if WBVT is safe and feasible for     individuals with SMA and if WBVT can improve muscle function, functional abilities, postural     control and bone mineral density in children with SMA. Convenience samples of 10 individuals     with SMA type III will be recruited. The participants will receive the WBVT of 25 Hertz and a     peak-to-peak amplitude of 4mm for a session of about 18 minutes, 3 days per week for 4 weeks.     Assessment will be performed at the baseline and the completion of the intervention to     examine the muscle function, functional abilities, postural control and bone mineral density     of the participants.      It is anticipated that the outcomes of this pilot study for SMA may show if this intervention     is safe, feasible and beneficial for children with SMA type III regarding to muscle function,     functional abilities, postural control and bone mineral content and if there may be any     related practical issues of this intervention to this population group. The outcomes also     provide research evidence to clinicians if this intervention should be recommended to     individuals of similar problems.   "
17527|NCT03056131|"     Tension Type Headache (TTH) is a frecuent type of headache disorder (about 1 person in 5     worldwide). Individuals with TTH typically present pericraneal tenderness and an increased     cervical muscle tone.      The most common treatment in primary care consists mainly on analgesic medication. However,     different techniques of manual therapy have been shown to be effective in the treatment of     these patients. Diacutaneous fibrolysis shows clinical benefits in relieving symptoms of     tension type headache, but there is no scientific evidence that analyzes this effects.      The hypothesis of this study was that adding treatment with diacutaneous fibrolysis to the     usual conservative treatment has beneficial effects on different variables of the headache.      The aim of the study was to assess the effect of diacutaneous fibrolisis on intensity,     frequency, duration of headache and cervical function in patients with tension type headache.      A randomized controlled clinical trial has been designed to evaluate the effectiveness of     diacutaneous fibrolysis technique compared to usual general practicioner care in patientes     with tension type headache.      The study protocol has been approved by the Clinical Research Ethics Committee from the     Aragon Community and all patients provided written consent.      Eighty-two people with clinical diagnosis of TTH were randomized into a intervention group or     a control group. Intervention group received three sessions of Diacutaneous Fibrolysis, while     control group was advised to maintain their usual pharmacologic treatment. Pain intensity     (VAS), frecuency, location, cervical range of motion, head forward position and pressure pain     thresholds (PPTs) were measured at baseline, postintervention, and 1 month follow-up after     treatment. The Spanish version of the HIT-6 Questionnaire was used to measure     disability/function at baseline and follow-up.   "
17528|NCT03056118|"     Investigators try to assess the safety of 6-months or 12-months maintenance of dual     antiplatelet therapy (DAPT, aspirin + clopidogrel) in patients undergoing percutaneous     coronary intervention using the Zotarolimus-eluting, Resolute Integrity™ stent (Medtronic     Vascular Inc, Santa Rosa, CA) or the BioMatrix™ stent (Biosensors. Singapore).   "
17529|NCT03056105|"     The purpose of this study was to examine how participation in a 1 month intensive Insight     (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social     affiliation, and inflammation, which are important for physical health, longevity, and     behavior, and (b) to relate observed biological changes to baseline levels and changes in     psychological traits, which may underlie improvements in personal adaptive functioning.   "
17544|NCT03055910|"     The Fractional Flow Reserve Fax Registry is an investigator-initiated, real-world registry to     analyze the use of fractional flow reserve (FFR) measurements in clinical practice in cardiac     catheterization laboratories in Germany. The registry aims to collect the data of 2000     patients who underwent FFR recordings for clinical reasons. The main outcome parameter is the     frequency of coronary revascularization following FFR. Secondary outcome parameters include     the distribution of quantitative FFR results in clinical practice, the influence of     intracoronary versus intravenous adenosine on the distribution of FFR results, the rate of     complications as a result of FFR measurements, the average number of FFR wires needed per     patient. Since the study will include a large number of patients who undergo i.c.     administration of adenosine and a large number of patients who undergo i.v. administration of     adenosine, it will be possible to analyze whether the route of adenosine administration is an     independent predictor of the FFR result.   "
17545|NCT03055884|"     The purpose of this study is to investigate whether it is possible to accelerate learning and     improve associative memory performance in healthy subjects, by (1) applying transcranial     Direct Current Stimulation (tDCS) during a verbal paired-associate learning task and by (2)     optimizing the learning method with repeated retrieval practice.   "
17530|NCT03056092|"     Objective: To determine the association between baseline aqueous cytokine levels and     treatment intervals for patients under a variable dosing regimen with intravitreal     ranibizumab in patients with neovascular age-related macular degeneration (nAMD), macular     edema secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME).      Methods: A prospective, single-centre study will be performed containing 3 sub-studies     according to each study population: nAMD, macular edema secondary to RVO and DME. Inclusion     criteria are: patients followed at St. Michael's Hospital with the diagnosis of nAMD, macular     edema secondary to RVO or DME. Patients will be excluded if visual acuity is worse than     counting fingers, with macular pathologies causing any structural changes to the retina, have     received anti-VEGF injections or photocoagulation therapy 6 months prior to study,     intraocular surgery 3 months prior to study, any history of vitreoretinal surgery or ocular     inflammation in the study eye, use of systemic or topical anti-inflammatory or steroids,     patients on dialysis for renal failure, allergy to the study drug or fluorescein, <18 years     old, women who are pregnant. All patients will be treated with ranibizumab intravitreal     injections on a variable dosing regimen: Patients with DME will be examined monthly and     receive mandatory injection for the first three months (baseline, weeks 4 and 8). Afterwards,     they will continue to be seen monthly and the need for new injections will be decided upon     the clinical findings at each visit. An anterior chamber (AC) tap will be done if an     injection is required at the visit. Patients with nAMD and RVO will be examined monthly and     receive mandatory injection for the first three months. From weeks 12 until 72 (month 18),     the visits will be scheduled at increasing 2-weeks intervals based on the stability of the     ocular condition and response to treatment. At each visit, an injection and AC tap will be     performed. The maximum interval in between injections is 12 weeks. If the disease becomes     unstable, the interval in between injections is shortened and, once it stabilizes, the     treatment frequency is extended again. In all patients, baseline aqueous humour specimens     will be obtained prior to the first ranibizumab intravitreal injection and follow-up samples     will be taken immediately prior to subsequent injections based on the treatment regimens for     cytokine analysis in the end of the follow-up.   "
17551|NCT03055793|"     The greater efficacy of combination therapy led to the development of fixed combination     devices which simultaneously carry both glucocorticosteroid and a LABA (eg stable     combinations of fluticasone-salmeterol, budesonide-formoterol).      Fixed combinations are easier to use for patients, potentially increasing compliance, and     ensure that the LABA always accompanied by glycocorticosteroeides1. From the available     combinations of the combination of budesonide-formoterol can be used both in maintenance     therapy and for the relief of symptoms due to the rapid onset of action of formoterol     compared with salmeterol. Both components of budesonide-formoterol combination when     administered on demand contribute to strengthening protection from severe exacerbations in     patients receiving combination therapy for maintenance, and enable improvement of asthma     control at relatively low doses of ICS.   "
17552|NCT03055780|"     The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect     functionally significant coronary stenosis.   "
17531|NCT03056079|"     Objective: To determine the association between baseline aqueous cytokine levels and     treatment intervals for patients under a variable dosing regimen with intravitreal     aflibercept in patients with neovascular age-related macular degeneration (nAMD), macular     edema secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME).      Methods: A prospective, single-centre study will be performed containing 3 sub-studies     according to each study population: nAMD, macular edema secondary to RVO and DME. Inclusion     criteria are: patients followed at St. Michael's Hospital with the diagnosis of nAMD, macular     edema secondary to RVO or DME. Patients will be excluded if visual acuity is worse than     counting fingers, with macular pathologies causing any structural changes to the retina, have     received anti-VEGF injections or photocoagulation therapy 6 months prior to study,     intraocular surgery 3 months prior to study, any history of vitreoretinal surgery or ocular     inflammation in the study eye, use of systemic or topical anti-inflammatory or steroids,     patients on dialysis for renal failure, allergy to the study drug or fluorescein, <18 years     old, women who are pregnant. All patients will be treated with aflibercept intravitreal     injections on a variable dosing regimen: Patients with DME will be examined monthly and     receive mandatory injection for the first three months (baseline, weeks 4 and 8). Afterwards,     they will continue to be seen monthly and the need for new injections will be decided upon     the clinical findings at each visit. An anterior chamber (AC) tap will be done if an     injection is required at the visit. Patients with nAMD and RVO will be examined monthly and     receive mandatory injection for the first three months. From weeks 12 until 72 (month 18),     the visits will be scheduled at increasing 2-weeks intervals based on the stability of the     ocular condition and response to treatment. At each visit, an injection and AC tap will be     performed. The maximum interval in between injections is 12 weeks. If the disease becomes     unstable, the interval in between injections is shortened and, once it stabilizes, the     treatment frequency is extended again. In all patients, baseline aqueous humour specimens     will be obtained prior to the first aflibercept intravitreal injection and follow-up samples     will be taken immediately prior to subsequent injections based on the treatment regimens for     cytokine analysis in the end of the follow-up.   "
17532|NCT03056066|"     The purpose of this study is to assess the accuracy of FRC and airway resistance calculate     values of Spircare device as compared to the conventional body plethysmograph in healthy     adults and patients with obstructive and restrictive pulmonary diseases/disorders.   "
17533|NCT03056053|"     The main study objective is to assess the content validity and the psychometric     characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).   "
17535|NCT03056027|"     Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will     be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before     and after surgery in order to rule out the potential impact of the surgical procedure on     testicular arterial and venous blood flow   "
17536|NCT03056014|"     Dietary supplementation with antioxidant vitamins, such as Vitamin C and Vitamin E, reduces     malformation rates in embryos of diabetic animals. However, human trials exploring the     benefits of these antioxidant vitamins have produced unsatisfactory results in trials     designed to alleviating diabetic retinopathy, cardiovascular disease, and preeclampsia in     pregnancies. The investigators hypothesize that more potent, and better-targeted     antioxidants, such as N-acetylcysteine (NAC) and Polyunsaturated Fatty Acids(PUFA), will be     successful in preventing birth defects in the offspring of women with diabetes.   "
17537|NCT03056001|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of doxorubicin     in combination with pembrolizumab in subjects with metastatic or unresectable soft tissue     sarcoma. Based on previous studies, pembrolizumab may be an effective study treatment.   "
17538|NCT03055988|"     The objectives of the study are to explore the effect of treatment with tiotropium +     olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC     on:        -  reversal of left ventricular diastolic dysfunction assessed with cardiac magnetic          resonance (CMR) imaging,        -  measures of arterial stiffness assessed by CMR and pulse wave analysis (PWA),        -  reduction of hyperinflation assessed with body plethysmography and        -  post dose spirometry.   "
17539|NCT03055975|"     Sampling of accessed root canals with endodontic paper points during treatment and     immediately pre-obturation of endodontic root canals was carried out.   "
17540|NCT03055962|"     Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study     conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50     milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged     50 to 85 years.   "
17541|NCT03055949|"     The purpose of this study is to determine whether an early rehabilitation program in surgical     intensive care unit is safe and effective in preventing critical care illness and intensive     care unit acquired weakness.   "
17542|NCT03055936|"     This is a phase I PK study in healthy males.   "
17543|NCT03055923|"     This Pilot study evaluates the use of a new device called Inflammacheck and whether it can     consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also     assess whether exhaled breath condensate hydrogen peroxide levels as measured by     Inflammacheck can differentiate people with asthma and COPD from healthy individuals.   "
17559|NCT03055689|"     This trial will evaluate the efficacy in colon cleansing of a nurse-led educational telephone     intervention 24-48 hours before a colonoscopy, in selected participants with a previous     inadequate bowel preparation.   "
17560|NCT03055676|"     The aim of this randomized prospective multicenter study is to demonstrate the hypothesis     that early removal of drain can reduce the incidence of pancreatic fistula and     intra-abdominal infection after pancreaticoduodenectomy , when compared with later removal of     drain.   "
17546|NCT03055871|"     The purpose of this study is to examine physical activity habit formation in parents and if     this can increase moderate to vigorous physical activity behavior in their children over six     months.The Primary Research Question is:      Does the habit formation condition result in increased moderate-vigorous intensity physical     activity of the child compared to the control (education) and education + planning conditions     at six months? Hypothesis: Child physical activity will be higher for the habit formation     condition in comparison to the more standard physical activity education and planning     conditions at six months.   "
17547|NCT03055858|"     The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized, open-label     study to characterize the safety and effectiveness of the ADO II AS device in patients with a     patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a     transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.      To account for subject dropout, up to 50 subjects will be enrolled in this clinical     investigation. The clinical investigation will be conducted at up to 10 centers in the United     States.      Subjects participating in this clinical investigation will be followed for 3 years. The     expected duration of enrollment is 18 months. The total duration of the clinical     investigation is expected to be 4.5 years.   "
20203|NCT03021109|"     The purpose of the study is assessment of volume status by bedside ultrasound in children     with acute gastroenteritis   "
17554|NCT03055754|"     Bariatric surgery procedures have consistently been demonstrated to reduce long-term     co-morbidities and mortality. Despite its benefits, weight regain is common, usually     initiating around two years after the initial procedure, the underlying mechanism often being     an enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass. Although a     reduction in the anastomosis diameter has been reported in association with endoscopic argon     plasma coagulation, to our knowledge this therapy has not been formally tested in a     randomized controlled trial. the objective of this study is to conduct a randomized, parallel     controlled trial comparing endoscopic argon plasma coagulation to reduce the enlargement of     the anastomosis diameter for the Roux-en-Y gastric bypass versus control with an initial     diagnostic endoscopic followed by observation. The investigators hypothesize that the argon     coagulation arm will achieve greater weight reduction, with a low incidence of adverse     events.   "
17555|NCT03055741|"     The objective of this study is to evaluate the efficacy and safety of DHP1401 in patients     with mild-moderate Alzheimer's disease treated with donepezil   "
17556|NCT03055728|"     The purpose of this study is to determine if the rapid antigen detection test for Group A     streptococcal pharyngitis diagnosis might yield higher rates of false positive results in     patients who have been treated for GAS pharyngitis within 28 days of the test.   "
17557|NCT03055715|"     The aim of the study is to retrospectively monitor the 'gross tumor volume' (GTV) before     initiation of radiotherapy and its changes during radiotherapy and to correlate them with     retrospectively recorded patient data, as well as with prognostic and therapeutic outcome     after definite radiotherapy of locally advanced NSCLC in stage UICC III.   "
17558|NCT03055702|"     A randomized controlled trial of patients with type 2 diabetes mellitus with multiple     appointments into short message service group and control group. The attendance rate of these     two groups of patients will be compared.   "
48811|NCT02646735|"     A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be     randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.   "
17561|NCT03055663|"     During spinal anesthesia, sedation is performed using intravenous sedative for the patient's     comfort and appropriate surgical environment. However, side effects of medications such as     respiratory depression, hypotension, bradycardia and desaturation cannot be avoided.     Recently, there have been developed a virtual reality experience equipment and a variety of     virtual reality programs including visuo-haptic computer technology. There have been clinical     studies that apply this technology to the pain medicine, sedation and medical education.     However, no study has been reported for the purpose of replacing sedation during spinal     anesthesia.      Therefore, we attempt to evaluate the efficacy and safety of sedation using virtual reality     meditation program during spinal anesthesia for urologic surgery.   "
17562|NCT03055637|"     Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus     two-flap palatoplasty for cleft palate repair.   "
17563|NCT03055624|"     Investigator-initiated study to evaluate the safety and efficacy of prostate artery     embolization for the treatment lower urinary tract symptoms in patients with benign prostatic     hyperplasia   "
17564|NCT03055611|"     Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor     products. The purpose of this non-interventional study is to describe the real-world usage     and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and     B.   "
17565|NCT03055598|"     This research study is for participants that have End Stage Renal Disease (ESRD). ESRD is the     last stage of chronic kidney disease. Anemia is very common in ESRD patients and require     erythropoiesis-stimulating agents (ESAs) for treatment. Anemia happens when there are not     enough red blood cells in your body. ESAs work by helping the bone marrow to produce red     blood cells. There are two ESAs licensed for the treatment of anemia of CKD in the Unites     States: epoetin alfa and darbopoetin alfa. ESA therapy is considered safe. However, major     adverse effects should be acknowledged, including an increased risk of death, thromboembolic     complications, stroke, heart attack, aplastic anemia, tumor progression, and others. To     minimize risks of these adverse events, careful monitoring of hemoglobin levels, along with     adjustment of ESA dosing, to maintain the lowest hemoglobin level clinically needed is     recommended.      Ferric Citrate, also called Auryxia, is an iron-based phosphate binder that may decrease ESA     usage while maintaining hemoglobin levels. Phosphate binders are medications used to reduce     the body's absorption of phosphate. In a prior study, it was seen that some laboratory     values, such as iron levels, changed positively in response to Auryxia. In this study we want     to see if using Auryxia will cause a change in laboratory values and lower the use of ESAs in     ESRD patients.   "
17566|NCT03055585|"     This cluster randomised trial will evaluate the efficacy of Wolbachia-infected Aedes aegytpi     mosquitoes in reducing dengue cases in Yogyakarta City, Indonesia   "
17567|NCT03055572|"     Persons with a loss of sense of smell, who agree to participate in this study, will be     assigned to one of three groups: two groups will have smell training and the third group will     not do smell training. Participants assigned to one of the smell training groups will be     asked to smell four different odors in rotation for five minutes two times per day, a total     of 10 minutes of participation per day, for 12 weeks. One smell training group will be given     odors made of fragrance oils to use for smell training. The other smell training group will     be given odors made of essential oils to use. Participants in all groups will continue taking     all medications and nasal rinses for sinusitis as prescribed by their doctor.   "
17568|NCT03055559|"     The haemoglobin level of the patients with iron deficiency should be increased clinical     relevant after 12 weeks treatment with GlobiFer Forte.   "
17569|NCT03055546|"     The aim is to examine whether intranasal oxytocin will influence the individuals' emotion     regulation ability and related neural mechanisms.   "
17604|NCT03055091|"     This is a randomized controlled trial of regular daily use of xylitol (or birch sugar), a     natural sweetener that has antimicrobial properties, for the prevention of acute otitis media     (AOM, primary outcome) as well as upper respiratory tract infections and dental caries (the     two secondary outcomes) in preschool aged children. This trial will be conducted through the     TARGet Kids! research network.   "
17605|NCT03055078|"     This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem     Cells transplantation in aplastic anemia.   "
17570|NCT03055533|"     Headsprout is a commercially available computer-based reading program that teaches children     fundamental reading skills, including phonics, fluency, and comprehension. The Headsprout     reading intervention has been shown to be effective with children with various levels of     reading skills, but it has not been rigorously tested in children with autism spectrum     disorder (ASD). The purpose of this study is to evaluate the effectiveness of Headsprout in a     pilot sample of 18 children with ASD and reading delays to serve as a foundation for a     larger, future randomized clinical trial (RCT).      Eighteen participants will be included in the study and randomly assigned to one of two     groups; the first group will immediately receive treatment with the Headsprout reading     program and the second treatment group will receive treatment after 12 weeks. Treatment     sessions will occur for one to two hours, two to four days a week, for twelve weeks. The     participants who do not receive treatment immediately will be asked to come in for reading     assessments periodically throughout their wait time.   "
17571|NCT03055520|"     A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an     errorless learning method for improvement of cognition in schizophrenia. Outpatients were     included after signing an informed consent. The trial consisted of 48 sessions of arithmetic     training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The     patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of     intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale     (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6     months (end of intervention) and 12 months after baseline. Primary outcome was the     performance on three cognitive domains (attention, executive functions and working memory).   "
17582|NCT03055377|"     This is a 12-week randomized, placebo-controlled trial of N-acetylcysteine for cannabis use     disorder (CUD) in youth (N=192). Participants will be randomized to double-blind NAC or PBO,     yielding two equally-allocated treatment groups. All participants will receive brief weekly     cannabis cessation counseling and medication management. The primary efficacy outcome will be     the proportion of negative urine cannabinoid tests during the 12-week active treatment,     compared between groups.   "
17658|NCT03054376|"     The study includes healthy young habitually active subjects. All subjects are subjected to     two weeks of immobilization of one leg followed by four weeks of training of both legs. The     subjects are randomized to either one-leg training of the non-immobilized leg during the     two-week immobilization period or to no training of the non-immobilized leg during the     immobilization period. Measures include skeletal muscle morphology, markers of angiogenesis     and apoptosis, muscle metabolic markers, vascular function, vascular proteins and     performance.   "
17572|NCT03055507|"     Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the     US, with about 250,000 cases performed annually. Currently, there is no consensus,     evidence-based post-operative pain regimen; with the majority of practitioners opting for a     combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs     due to decreased platelet aggregation and the theoretical risk of increased post-operative     bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following     ESS. Additionally, there is a lack of information regarding the average narcotic requirement     following ESS.      The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in     sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This     investigation will help to gain understanding of current opioid use in post-op sinus patients     and assess the safety and effectiveness of post-operative ibuprofen administration on pain.     The investigators aim to quantify the average narcotic use following ESS, as well as evaluate     the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and     post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will     decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do     not use ibuprofen post-operatively, this will lead to decreased opioid use in the     post-operative period. Additionally, the investigators hypothesize no increase in     post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding     events.      In summary, this will be the first study to the investigators knowledge to examine the effect     of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis     outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will     be equipped to design and perform the optimal prospective, randomized study evaluating the     effect of NSAID in ESS during the post-operative period. The overarching goal of this     investigation is to decrease opioid use in post-operative pain control following ESS.   "
17573|NCT03055494|"     This study will provide a comparison of secukinumab to placebo with respect to skin     inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and     blood sample analyses.   "
17574|NCT03055481|"     The aim of this trial is to show that the low irradiance level is not worse than the high     irradiance level in the phototherapy for neonatal jaundice.   "
17575|NCT03055468|"     Introduction: The prevalence of Diabetes Mellitus (DM) is on the rise the world over. About     30% of DM patients suffer from Depression. Depression in DM patients is associated with     adverse outcomes including poor medication adherence, poor glycaemic control, and early     death. In resource constrained sub-Saharan Africa (SSA) clinics where patient volumes are     high and staff shortages rife, peer support has been suggested as a means of delivering     psychosocial care for persons with chronic illnesses in order to improve patient's outcomes.     However, little has been done to examine the efficacy of peer support on clinical outcomes.      Project aims: The main study objective will be developing a peer support model of depression     care for patients with DM and testing its efficacy on clinical outcomes.      Methods: This study will employ both qualitative and quantitative measures. First, the     investigators will present the peer support model to health workers within the DM clinic, and     ask them about the feasibility of using such a model for DM patients with depression. The     investigators will then identify 10 DM patients with major depression and initiate them on     antidepressants. Once the patients are in clinical remission, the investigators will     interview them to assess their perceptions about the feasibility of using peer support for DM     patients newly diagnosed with depression. The investigators will also interview health care     workers and hospital administrators to assess their perception about using peer support     within the clinics, and potential barriers that need to be addressed before implementation of     the model.      Based on the data from the qualitative interviews, the investigators will refine and adapt     the peer support model, and then train 10 DM patients who have received antidepressants and     are in clinical remission to deliver peer support to newly diagnosed patients with     depression. Newly diagnosed depressed patients will be randomly assigned to receive either     antidepressants plus peer support (n=65) or antidepressants alone (n=65). Study participants     will be followed for 48 weeks and assessed for, glycaemic control, depression severity,     mental illness stigma, depression treatment uptake and adherence.      Result: the investigators anticipate that the findings about the efficacy of peer support on     DM and depression outcomes will be useful in generating data about effect sizes necessary for     calculating a sample size for a cluster randomized trial (CRT).   "
17576|NCT03055455|"     In critically ill children with severe sepsis, neurophysiologic derangements often proceed     undetected and can lead to irreversible brain injury causing neurocognitive and behavioral     deficits. The etiology of these impairments is unclear, however, it is likely that some of     this neural injury is preventable. The overarching goal for this study is to show that acute     acquired structural and microstructural brain injury occurs in critically ill children with     severe sepsis, and that this injury is related to neuropsychological deficits and impaired     cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within     2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation     of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood     pressure with middle cerebral artery flow velocity measured by transcranial doppler     ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will     also participate in a neuropsychological evaluation 6 months after enrollment to evaluate     multiple domains of behavior and cognition.   "
17578|NCT03055429|"     The mission of corrections is to provide custody, control and care for incarcerated     individuals. United States prisons are required by constitutional law to provide adequate     care for growing numbers of older inmates who will likely spend their final days in prison.     This Phase II project focuses on the correct users accessing correct learning strategies in     the correct setting (i.e., interdisciplinary prison staff accessing high quality products     designed to educate and lead practice change initiatives within the walls of prisons), by     continuing research and development of a learning system that promotes an integrated systems     approach to enhancing the care of the aged and dying in prisons.   "
17579|NCT03055416|"     African American men are at risk of developing chronic disease partly due to low levels of     regular physical activity. Studies have been effective in increasing physical activity levels     in African American men; however for the health benefits of exercise to be maintained     continued physical activity is necessary. The purpose of the current study is to develop a     mobile phone application for African American men that will help them maintain their physical     activity levels.   "
17580|NCT03055403|"     This Phase I first-in-human is designed to evaluate the safety, tolerability and     pharmacokinetics of single ascending doses of M201-A administered by single continuous     intravenous injection in Healthy Japanese subjects.   "
17581|NCT03055390|"     A case control trial Patients who meet the inclusion criteria were asked to participate in     the study and a written consent was obtained from each patient after explaining thoroughly     the nature and the scope of the study.      Patients were divided into three equal groups:      Group A: included 40 pregnant patients. They received two ml of normal saline intravenously     as a placebo.      Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml     HBB+ one ml saline) intravenously.      Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide     intravenously (HBB).   "
17595|NCT03055208|"     Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free     survival time after addition of an early gamma knife boost to areas of residual tumor to     standard-of-care (surgery, chemo-radiotherapy, chemotherapy).   "
17583|NCT03055364|"     In this study, the investigators propose to evaluate cognitive function and determine the     feasibility of neurocognitive assessment using a select CogState test battery in patients     with primary intracranial malignancies receiving photon- or proton-based cranial irradiation     with curative intent. The investigators will use the CogState software to quantify changes in     verbal learning, memory, and executive function over the initial months and years following     radiation treatment. Cognitive changes and temporal patterns of function will be compared to     baseline performance for each patient. Data regarding cognitive function, fatigue, quality of     life, and standard patient reported outcomes will be collected to characterize the daily     impact of treatment. In addition, observed outcomes will be correlated with dosimetry values,     radiation dose volumes, and anatomic dose distribution.   "
17584|NCT03055351|"     Stop&Go is an intervention program aimed at promoting a healthy and physically active     lifestyle for patients requiring inpatient detoxification treatment. The program includes two     different phases. Phase I is aimed at understanding the variables related with adherence to     healthy lifestyle interventions. Phase II will use the knowledge obtained in Phase I to     develop and evaluate an intervention based on Self-determination theory to promote healthy     and physically active lifestyles for patients admitted to an inpatient detoxification centre.     The Stop&Go intervention is hypothesized to help patients move towards a healthy lifestyle     and thus, may bring about changes in patients' (1) knowledge acquired, (2) indicators of     healthy habits (e.g., exercise motivation) and (3) psychological well-being and ill-being.   "
17585|NCT03055338|"     This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial     of MK-8189 compared with placebo, using Risperidone as an active control. The participants     will be adult subjects experiencing an acute episode of schizophrenia, according to the     criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed.     (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each     participant. The study will consist of a Screening/tapering period (up to one week long), a     4-week treatment period, and a 14-day follow-up period. The primary objective will be to     assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during     treatment and post-treatment follow-up. The secondary objective will be to assess the     severity of schizophrenia at 4 weeks. The primary hypothesis is that MK-8189 is superior to     placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from     baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of     treatment.   "
17586|NCT03055325|"     The aim is to map the inflammatory response after surgery and further investigate the     mechanisms by which inflammation is regulated. The inflammatory cascade is pivotal in     protecting organisms against invading pathogens and in enabling healing of damaged tissues,     yet the cascade itself may be harmful to the organism when excessive (e g septic chock).      The increased immune-reactivity after trauma, such as surgery, is furthermore associated with     post-operative declines in memory and learning capacity, a condition likely related to the     notion of sickness behavior. The effects on the brain after surgery and the associated     neuro-immune crosstalk will now be investigated with focus on changes in immune reactivity in     peripheral blood after surgery.   "
17587|NCT03055312|"     Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's     Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast   "
17588|NCT03055299|"     The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility,     tolerability and adherence of this novel video-based intra-dialytic chair exercise program     for hemodialysis patients over 3 months.   "
17589|NCT03055286|"     This is a multicenter (S. Korea/US), Phase Ib, open-label, dose-finding study to assess     safety, PK, PD, and preliminary efficacy of CWP232291 administered in combination with ara-C     in subjects with relapsed or refractory AML. Based on the poor prognosis of     relapsed/refractory AML, exploration of alternative doses and regimens will be evaluated and     approved by a Safety Review Committee (SRC).   "
17606|NCT03055065|"     The objectives of this study is to assess the characteristics and frequency of adenovirus     conjunctivitis in a population of male and female patients from one year of age who present     signs and symptoms of acute conjunctivitis.   "
17590|NCT03055273|"     This research is being done to find out the best ways to help people with end stage kidney     disease take care of their daily lives and improve their social functioning.      Investigators want to learn whether services in the Community Aging in Place, Advancing     Better Living for Elders (CAPABLE) study such as help with medications, muscle strengthening,     balance training, pain management, changes to houses and improved social support can be     tailored to fit the needs of older adults with kidney disease to help improve their ability     to balance, walk, and take care of themselves.      People aged 60 years and older who have end stage kidney disease and have been receiving     dialyses for at least 6 months, may join.   "
17591|NCT03055260|"     The particpant will complete baseline testing by measuring subjects' quadriceps muscle     thickness (cm) via ultrasound technology, as well as have them complete a one repetition     maximum (1RM) test on the leg press machine and an isometric knee extension using a     dynamometer - strength measures will be calculated for both right and left legs. After     baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of     leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff     that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does     not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take     approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6     weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested     and compared to the initial measurements.   "
17592|NCT03055247|"     This is a phase II exploratory study conducted to evaluate the safety and efficacy of the     combination of Ibuprofen, G-CSF and Plerixafor as stem cell mobilization regimen in patients     affected by X-CGD.   "
17593|NCT03055234|"     This is a multicenter, randomized (2:1; oral treprostinil:placebo), double-blind,     placebo-controlled event-driven (time to pulmonary hypertension [PH] clinical worsening)     study in subjects with PH associated with sickle cell disease (SCD). Once enrolled, subjects     will be evaluated at Weeks 6, 12, 24, and then every 12 weeks for the duration of the study.     Subjects will be permitted to enter a 48-week open-label extension period if they experience     a PH clinical worsening event.   "
17594|NCT03055221|"     This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated     Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study     RIV-PH-402 were eligible to enroll.   "
17596|NCT03055195|"     Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on     Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment,     activation, and survival of eosinophils; thereby reducing the production and survival of     eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study will     investigate the efficacy and safety of mepolizumab (100 milligram [mg] subcutaneous [SC]     administered every 4 weeks) compared with placebo in adult subjects with moderate to severe     atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or mepolizumab     SC. The study will comprise of a pre-screening period of up to approximately 4 weeks, a     screening period of up to 2 weeks, followed by a 16-Week study treatment period (16 weeks     with the last dose of study treatment at Week 12) and follow-up period of up to 4-week. The     total duration of subject participation will be approximately 26 weeks. (Note: For subjects,     who may need to stop treatment with a biologic, the total Pre-Screening and Screening period     may last up to 20 weeks and total duration of participation in the study may be up to 40     weeks).   "
17597|NCT03055182|"     The study evaluate paraspinal aerobic metabolism of chronic low back pain patients and     healthy people during an original and standardized isokinetic protocol.      The aim of this study is to determine a potential alteration of muscular aerobic metabolism     in low back pain patients, in order to establish the underlying cause of pain and muscular     fatigability characterizing low back pain patients. Then, the aim is to determine if     functional rehabilitation program can improve it.      the unit of care have access to metabolic adaptations in measuring the muscular oxygenation     and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.   "
17598|NCT03055169|"     This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2     gene and the risk of developing hyperglycemia during Intensive care unit stay   "
17599|NCT03055156|"     The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e.,     airweave®) on sleep and sleep-related symptoms.      The study will compare effects of use of high rebound mattress toppers versus use of low     rebound mattress toppers on sleep and sleep related symptoms and core body temperature during     diagnostic sleep studies.   "
17600|NCT03055143|"     This was a randomized, multi centre, open label, two treatment, two period, two sequence,     single dose, crossover study, with at least 28 days washout between doses, conducted under     fed (normal breakfast) conditions.   "
17601|NCT03055130|"     The associations between female inflammatory bowel disease (IBD) patients and human papilloma     virus (HPV) infection and cervical neoplasia (dysplasia or cancer) were unclear. Especially     there was no data for Chinese IBD population. So we investigated the incidence and risk     factors of HPV infection and cervical neoplasia (dysplasia or cancer) in female IBD patient.   "
17602|NCT03055117|"     Degenerative shoulder disorders are frequent in the Danish population and often cause     disability and sick leave. After hospital discharge patients are often referred to     physiotherapy rehabilitation as part of the treatment, and it is often assumed that     one-on-one sessions will yield better results than group-based sessions, because individual     needs can be better meet and targeted      The project aims to evaluate the effect and cost-effectiveness of group- based exercise     rehabilitation as compared to individual exercise rehabilitation in patients with     degenerative shoulder disorders.   "
17603|NCT03055104|"     Severe malnutrition can be seen as a low BMI, great weight loss, and even low levels of     micronutrients. Current studies on severe malnutrition are mainly in patient with anorexia     nervosa. The refeeding phase of these high-risk patients bears a further threat to health and     potentially fatal complications (such as refeeding syndrome, infection and severe     arrhythmia). The objective of this study is to investigate complications due to refeeding of     patients with severe malnutrition, as well as their mortality rate, establish and modify the     guideline for management of severe malnutrition in Peking University Third Hospital.   "
20233|NCT03020719|"     The purpose of this randomized, placebo-controlled (Phase II) study will be to further     evaluate the effects of oral glutathione on growth in children with CF.   "
17608|NCT03055039|"     The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy.     During the delivery the baby is exposed to multiple exterior factors and he is capable to     memorize the pain .Recent epidemiologic studies showed that the coverage of pain was     insuffcient and also an increase of analgesic means. Normally the pain coverage have to be     managed and group every painful gesture. In fact all these recommandations are not followed     by medical team.      The aim of the study is to evaluate the prevalence of this type of pain as to set up an     adequate coverage.   "
17609|NCT03055026|"     Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for     colorectal cancer: a randomized, double blind, placebo-controlled study.   "
17611|NCT03055000|"     Background:      Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v     vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne     diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person.      Objective:      To see if the AGS-v vaccine is safe in humans and how it affects the immune system.      Eligibility:      Healthy adults ages 18-50      Design:      Participants will be screened another study.      Participants will be randomly assigned to get either the vaccine with a booster vaccine, the     vaccine without the booster, or a placebo. These are given through a needle in the upper arm.      Participants will have visits that include medical history, physical exam, and blood and     urine tests:      Baseline: They will get the vaccine and be monitored for 2 hours.      Follow-up visits 1 and 2 weeks after baseline.      Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours.      Follow-up visits 1 and 2 weeks after booster visit.      Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the     lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the     feeding.      Phone follow-up a few days after the mosquito feeding.      After the feeding visit, 5 follow-up visits about every 2 months      Participants will keep a symptom diary for 7 days after each vaccine. They will record their     temperature. They will measure any redness around the injection site. They will document and     if possible photograph any mosquito bites they get.   "
17612|NCT03054987|"     The purpose of this study is to compare the need to use mechanical lithotripsy between     patients undergoing POC-LL and EBS for removal of difficult bile duct stones   "
17613|NCT03054974|"     The purpose of this study is to determine the effectiveness,safety and Input-output ratio of     chinese traditional treatment in spasm after stroke,both in massage and herbal medicine     bathing.   "
17614|NCT03054961|"     The purpose of this pilot study is to describe the relationship of regional cerebral oximetry     and cytoximetry, measured using near-infrared spectroscopy, with seizure activity in the     periictal period in children with epilepsy.   "
17615|NCT03054948|"     Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US.     Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be     associated with a number of complications including inflammation, abnormal liver function     tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the     FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain     triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to     omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of     intolerance to soybean oil IVFE. This study is designed to investigate the impact of     SMOFlipid in prolonged use.   "
17616|NCT03054935|"     The aim of this study is to investigate the effect disease activity on resting energy     expenditure (REE), body composition, inflammatory markers, food intake and quality of life in     subjects affected by Crohn's Disease (CD)   "
17617|NCT03054922|"     During major surgical procedures, intravascular volume is maintained with the administration     of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three     of these fluids are in common clinical use for this purpose. As large volumes of NS may     result in a dilutional acidosis and an increasing base deficit, it may cloud clinical     decision making when resuscitative efforts are guided by acid-base status on routine arterial     blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base     and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids     for intraoperative resuscitation.   "
17618|NCT03054909|"     This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex     (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy     for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.   "
17619|NCT03054896|"     This research study is evaluating the combination of a study drug, venetoclax, and a standard     chemotherapy regimen, EPOCH-R, as a possible treatment for Richter's Syndrome.      The drugs involved in this study are:        -  Venetoclax        -  EPOCH-R:        -  Etoposide        -  Prednisone        -  Vincristine Sulfate (Oncovin)        -  Cyclophosphamide        -  Doxorubicin Hydrochloride (Hydroxydaunomycin)        -  Rituximab   "
17620|NCT03054883|"     This is an observational study aimed to analyze the effectiveness of treatment of patients     with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem     cell transplantation. Scheme of treatment: alternating cycles of R-CHOP (rituximab,     cyclophosphamide, hydroxydaunomycin, oncovin, prednison) and R-AraC (rituximab, cytarabin):     R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. The study was proposed based on the     previously published data in the younger patients, which demonstrated improved outcome after     implementation of Ara-C into induction.   "
17621|NCT03054870|"     Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to     Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas     compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory     distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per     medical needs followed by Technegas ventilation imaging per study protocol.   "
17653|NCT03054441|"     In hemiplegia quantitatively measurement of the asymmetry in the use of upper limbs could     overcome the limitation of many outcome measures in which scores are dependent on the     experience and training of the therapist. The main aim of this study was to determine the     validity of Actigraph GXT3+ to measure asymmetry in the use of the two upper limbs during the     Assisting Hand Assessment (AHA) in children, adolescents and young with hemiplegia aged 5-19     years, compared to age-matched typically developing subjects (TD).   "
17622|NCT03054857|"     Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing     postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use     cardiopulmonary bypass machine (CPB).      Materials and Methods: This study was double-blinded, randomized controlled trial. Patients     scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups,     dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless     test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined     as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for     IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1),     arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD     and the secondary outcomes were inflammatory response, other postoperative complications, ICU     and hospital stay.   "
17659|NCT03054363|"     This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug     combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib     and aromatase inhibitor letrozole) as a first or second line of therapy in patients with     metastatic hormone receptor positive and HER2-positive breast cancer.   "
17623|NCT03054844|"     Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population     for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and     distressing procedures, such as laceration repairs. Intranasal midazolam is both effective     and safe in children. However, due to the acidic nature of midazolam, there is a burning     sensation that is associated with the intranasal administration of midazolam. The use of IN     lidocaine has been shown to decrease the pain associated with the administration of IN     midazolam and other acidic solutions. The IN lidocaine can be given as a premedication     (PREMED), where it is sprayed in the nares first to provide topical anesthesia, and then     followed by the administration of the IN midazolam. Lidocaine can also be given concurrently     with the IN midazolam (PREMIX), where it is mixed with the midazolam and then the combined     mixture administered. Both methods have been shown to be effective in decreasing the pain     associated with the intranasal administration of acidic solutions, such as midazolam,     although the PREMIX method could have the advantage of requiring less number of sprays, and     be tolerated better by children. Although both methods have been shown to work, it is not     known if the PREMIX method is non-inferior to the PREMED method for decreasing pain and     distress associated with administering IN midazolam. Therefore, the investigators aim to     determine if the PREMIX method is non-inferior to the PREMED method of using lidocaine to     decrease the pain and distress associated with the administration of IN midazolam in     children.   "
17624|NCT03054831|"     Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of     pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used     in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it     does in the body) and pharmacodynamics (how it works) have not been well established in     children. Some children, because of their specific genetic make-up, may metabolize the drug     more quickly and therefore may be at risk for more side effects in the commonly prescribed     dose. The investigators would like to find out more about how general anesthesia (GA) effects     how this drug is absorbed, metabolized and excreted in children. In order to study these     aspects, the investigators would like to give oxycodone to surgical patients (group one will     receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of     GA) at Boston Children's Hospital then measure its metabolic activity and also perform a     specific genetic analysis.   "
17625|NCT03054818|"     This is a post-marketing drug safety monitoring study in a prospective manner, and data     collection will be performed in a registration-follow-up manner. Safety information about     patients who have received intravitreal injection of Conbercept Ophthalmic Injection in     medical institutions involved in the study during research will be actively monitored without     intervening in diagnosis and treatment. All patients enrolled will be followed up for one     year.   "
17626|NCT03054805|"     To compare the differences of fecal microflora between constipated and non-constipated     healthy children, and evaluate the efficacy of probiotics in reducing symptoms of     constipation and the influence of intestinal microflora in children with functional     constipation.   "
17627|NCT03054792|"     This study will test the feasibility of using novel/existing imaging technologies focused on     hypoxia measurements to determine response to therapy in pediatric soft tissue sarcomas as     a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen     Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, Magnetic Resonance Spectroscopy (MRS)     and 18F-FAZA PET-MRI with that of conventional MRI to detect measurement changes between the     start and completion of neoadjuvant therapy (response to therapy) in children and     adolescents (7-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use     results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic     schemes to patients on a personalized basis.   "
17628|NCT03054779|"     Building on the findings from the investigators previous study, COMIT I, the purpose of the     COMIT II study is to supplement the DEXA measurement of body composition with a supplementary     DEXA measurement of visceral adipose tissue and to specifically target the impact of oleic     acid consumption on body composition as the primary objective. COMIT II also will include     analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate the mechanisms     by which canola oil may be modifying body composition, measurement of endothelial function,     inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.   "
17629|NCT03054766|"     To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal     injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long     term.   "
17630|NCT03054753|"     The postoperative shoulder rehabilitation in an abduction brace after rotator cuff     reconstruction of the shoulder is crucial for a successful healing of the reconstruction.      In this study the investigators want to analyse the abduction brace-wearing time using a     electronic sensor, which is implanted in the abduction brace. The participants will be     informed about the sensor after completion of the abduction brace rehabilitation 6 weeks     postoperatively.   "
17631|NCT03054740|"     The primary purpose of this study is to determine if by offering a vapocoolant (cold spray)     to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient     satisfaction of IV insertion as well as determine if pain of insertion is decreased.   "
17642|NCT03054584|"     The objective of this protocol is to further elucidate the genetic mutations that drive     melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole     genome, whole exome, or targeted sequencing of de-identified specimens.      Herein, we plan to isolate DNA from de-identified skin biopsy specimens and blood samples:        1. From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the          tissue will be submitted for routine diagnostic dermatopathology and investigational          histomorphologic and immunohistochemical analysis.        2. From corresponding normal tissue (blood). DNA isolated from blood will be used as a          normal control when analyzing sequencing data to identify somatic mutations in lesional          tissue.   "
17643|NCT03054571|"     This investigation seeks to build upon existing evidence that a relationship exists between     body mass and timing and the number of erupted teeth.   "
17660|NCT03054350|"     This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess     the efficacy, safety, tolerability, PK, and PD of orally administered vadadustat in Japanese     subjects with anemia secondary to DD-CKD.   "
17632|NCT03054727|"     Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein     thrombosis (DVT). In the absence of curative treatment of established PTS, its management is     based on the prevention of its occurrence thanks to anticoagulants and compression stockings.      So far, predictors of disabling PTS are unknown precluding from optimally selecting patients     for invasive (early thrombus removal) or innovative/expensive treatments. In addition, little     is known on the incidence of PTS in the very long-term.      Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event,     Primary objective: incidence and severity of PTS after a lower limb DVT.      Main Secondary objectives:        1. Incidence and severity of PTS according to VTE initial presentation (isolated distal          DVT, isolated proximal DVT, PE + DVT).        2. Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12 years)          of patients recruited in the large, multicentre, prospective, observational OPTIMEV          study for a suspicion of VTE confirmed or ruled out with objective tests (Clinical          Trials NCT00670540).      All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients     without any history of VTE after the 3 years of follow-up) will first benefit from a     phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a     selection of controls will undergo a clinical follow-up visit with clinical and Compleat     Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of     life.      Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of     usual treatment. Better selecting patients eligible for invasive/innovative/expensive     preventative procedures.   "
17633|NCT03054714|"     Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed     replacement, versus exchange over a guidewire to treat catheter related blood stream     infection   "
17634|NCT03054701|"     Patellofemoral pain (PFP) is highly prevalent in both adolescent and adult populations and as     much as 91% of those affected experience ongoing knee pain for up to 20 years after the     initial diagnosis.      Exercise-based treatment focusing on strengthening the muscles around the hip and knee is     usually effective when treating patient with PFP. However, this approach has proven     ineffective in a subgroup of females who have suffered from PFP for multiple years.      This group was found to have a significantly lower tolerance for pressure stimuli compared to     healthy controls. This indicating that central mechanisms within the nervous system rather     than the problem being the knee itself.      Exercising a non-painful muscle distant to a painful part of the body has previously been     effective in deceasing pain in affected area. This mechanism has been investigated in     patients with long-standing musculoskeletal pain as well as healthy populations.      Related research has suggested that a possible link between patients perception of painful     stimuli an the pain-reducing effect of exercise exists. As such, patients witch experienced a     pain reducing effect of exercise was found to be able to tolerate more pain than before the     intervention.      The aim of this study is to assess if exercising a distant non-painful muscle around the hip     has a larger acute pain-reducing effect on knee pain compared to knee specific exercises in     female patients with long-standing PFP.   "
17635|NCT03054688|"     Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.   "
17636|NCT03054675|"     Aim of this study was to prospectively investigate the correlation between postoperative     spirometry values and pulmonary complications after anatomic lung resections. In addition,     the investigators compared postoperative pulmonary function changes between open and     minimally invasive approaches.   "
17637|NCT03054662|"     This study aims to make an inventory of the condition and care of patients with haemophilia     and carriers for haemophilia in Ivory Coast and to promote the use non substitutive     strategies that are not costly and available in Ivory Coast, to improve the management of     haemophilia in this country. The purpose of this project is to evaluate the extent to which     the active promotion of these various measures will improve the care of patients with     haemophilia and carriers in Ivory Coast.   "
17638|NCT03054636|"     The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data     from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information on     device performance in a real-world setting.   "
17639|NCT03054623|"     Our study seeks to define the effect of each component of the distal revascularization     interval ligation (DRIL) procedure on the in vivo distal blood pressure of patients with     ischemic steal, and to determine whether the interval ligation component of the DRIL     procedure is necessary or not.   "
17654|NCT03054428|"     To demonstrate the efficacy of dupilumab as a monotherapy in patients ≥12 years to <18 years     of age with moderate-to-severe atopic dermatitis (AD)   "
17655|NCT03054415|"     This study aims to assess the phenotype of the enteric nervous system (enteric neurons) in     healthy subjects.      The enteric nervous system (ENS) is composed by enteric neurons and enteric glial cells.     There is a cross-talk between ENS and the intestinal epithelial barrier (IEB). ENS and IEB     together constitute the neuronal-glial-epithelial unit. This unit has a key role in gut     functions. The characteristics and the phenotype of the ENS also change according to age and     environmental factors. Similar study is ongoing for patients with Spina Bifida. Anorectal     data and phenotype of the neuronal-glial-epithelial unit in healthy subjects is required to     assess abnormality of these items in patients with neurological disease including Spina     Bifida.   "
17640|NCT03054610|"     Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in     people 40 years of age or older, overweight, sedentary or with intense physical activity. It     is caused by the over-stretching of the plantar fascia, which is a band of connective tissue     that extends to the base of the phalanges. This produces micro-tears more commonly in its     origin in the medial tuberosity of the calcaneus which causes an inflammatory process and     pain. This pain usually occurs when the person gets up in the morning after sleeping or after     sitting for a long time. That is when the fascia is stretched after being in a contraction     position.      There are a great variety of treatments for this pathology, of these, one of the most common     is the use of intralesional steroids, which a weighing that reduces symptomatology in many     cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar     fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are     extracorporeal shock waves, application of platelet-rich plasma and application of botulinum     toxin A intralesional. All of them are accompanied by insoles, night splints and stretching     exercises of the Achilles tendon and the plantar fascia.      Recent studies have shown that the application of botulinum toxin A intralesional in patients     with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity     and presentation time. Decreased inflammation of the plantar fascia has also been     demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is     applied regularly in the muscles to block the release of acetylcholine in the neuromuscular     plaque and obtain its relaxation and not directly in the pain points. We believe that the     botulinum toxin can be applied intralesional currently, since there is information that the     toxin has analgesic and anti-inflammatory effect and not just muscle relaxation.      The aim of our work demonstrate that the use of botulinum toxin A and intralesional     stretching exercises is superior to intralesional steroids and stretching trying to establish     a safer and less painful therapy avoiding complications prior to the application of steroid     application.   "
17641|NCT03054597|"     Children in the United States watch an average of twenty-eight hours of television and play     around thirteen hours of video games per week. The objective of this experiment was to see if     a specific eye exercises could strengthen the eye muscles and improve the peripheral vision     range of children and adults.   "
17661|NCT03054337|"     This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess     the efficacy, safety, tolerability, PK, and PD of orally administered vadadustat in Japanese     subjects with anemia secondary to NDD-CKD.   "
48936|NCT02645097|"     This research is being done to compare two different saphenous nerve block locations and will     help to determine which site best maintains knee strength and pain control.   "
17644|NCT03054558|"     Patients with history of two or more recurrent pregnancy loss (RPL) and no history of living     babies who had performed all investigations for recurrent miscarriage (RM) including :     laboratory investigation ,trans vaginal ultrasound (TVS) ,autoimmune work up and hystroscopy     and all results were free,will be scheduled for three dimensional trans-vaginal ultrasound     (3D TVS) in the midluteal phase for measuring the impedance of uterine artery blood flow( by     two dimensional Power Doppler TVS).Also by using 3D power Doppler the sub-endometrial blood     flow will be assessed. In addition to the thickness of Junctional Zone (JZ) by using coronal     view of 3 D TVS. To be compared with patients who had at least one full term living baby     through normal vaginal delivery with no history of early pregnancy loss.   "
17645|NCT03054545|"     This study is to evaluate the efficacy and safety of a novel chemical synthetic agent     iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one     failed immunosuppressive treatment and suffer active nephritis at the screening stage. The     study period is 52 week. All the subject will receive therapy of iguratimod combined with     steroids.   "
17646|NCT03054532|"     This is a multi-center, open-label, phase II study of durvalumab in combination with     lenalidomide for treatment of relapsed/refractory NK/T-cell lymphoma (NKTCL). The study will     employ a 2-stage Simon Optimal design with 80% power and type 1 error rate (significance     level) of 5%. Stage 1 will involve 8 patients and will require at least 2 patients to achieve     the primary end point of overall response in order to proceed onto to stage 2, which will     have a target enrolment of 14 patients.   "
17647|NCT03054519|"     The PERMET trial will determine whether metformin daily for six months improves six-minute     walk performance in individuals with peripheral artery disease compared to placebo.   "
17648|NCT03054506|"     Constipation is a common gastrointestinal motility disorder that is often chronic, negatively     affects patients' daily lives. Constipation occurs when bowel movements become difficult or     less frequent.This study is being done to study the effectiveness of the hydrogel capsule,     CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine     sugar pill), to relieve constipation among subjects with chronic idiopathic constipation     (CIC) or with irritable bowel syndrome with constipation (IBS-C).   "
17649|NCT03054493|"     1. Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged          3-8 years old in Giza Governorate.        2. Assessment of factors associated with NNSH.   "
17650|NCT03054480|"     Because of the limiting data about an efficacy and safety of fractional radiofrequency for     the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis     Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and     intradermal Botulinum toxin type A injection for the treatment of primary axillary     hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch     test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's     satisfaction and their quality of life by Dermatology Life Quality Index and side effect     between the groups.   "
17651|NCT03054467|"     The aim of the present study is to compare the effects of CCB and CCB+ high dose of statin     therapy on the symptoms, function, and quality of life assessed by validated angina-specific     questionnaire (Short-form Seattle Angina Questionnaire (SAQ-7)), endothelial function as     measured by FMD of the brachial artery, endothelial progenitor cells (EPC) and coronary flow     reserve (CFR) in patients with VSA.   "
17652|NCT03054454|"     Observational studies clearly show that people with diabetes and end-stage kidney failure     have an increased risk of foot ulceration and leg amputation. However, there is very little     evidence on addressing this problem.      Diabetes foot care teams have been shown to reduce hospital admissions, length of stay and     leg amputation in people with diabetes. Since their introduction at The James Cook University     Hospital (JCUH) major diabetes-related leg amputation rates have fallen by 86 percent (1995     to 2010).      People with diabetes and end-stage kidney failure require haemodialysis (blood cleaning) 3     times per week for several hours each time. This time commitment makes it difficult to attend     other clinical appointments. An audit at JCUH shows that this population fails to attend the     normal diabetes foot services.      This project aims to reduce the incidence of foot disease in people with diabetes and     end-stage kidney failure on dialysis. The investigators will set up a podiatry-led     intervention within the dialysis unit to prevent and promptly treat foot disease in this     population. This will involve foot risk assessment, risk reduction and treatment during     dialysis. The intervention will involve diabetes consultants, podiatrists, vascular and     orthopaedic surgeons . In this way the investigators hope to reduce leg amputation, hospital     admission, procedures to unblock arteries and death in this high risk group.      The study will run in the dialysis unit at JCUH. Patients will be divided into two groups:     those attending for dialysis on a Monday, Wednesday and Friday will form the treatment group     and those attending on a Tuesday, Thursday and Saturday will continue to be managed as at     present. The investigators will collect data from patient health care records looking in     particular at leg amputations, hospital admissions due to foot problems, foot surgery and     operations to unblock arteries.   "
17662|NCT03054324|"     Coronary fraction flow reserve (FFR), the ratio of the mean coronary pressure distal to a     coronary stenosis to the mean aortic pressure during maximal coronary blood flow (hyperemia),     defines the hemodynamic significance of coronary artery narrowing. Noninvasive assessment of     FFR via a combination of computational fluid dynamics (CFD) and coronary CT angiography CCTA     (the so-called FFRCT) has potential. Coronary computed tomographic angiography is a     noninvasive test for diagnosis of anatomic coronary stenosis (i.e., narrowing of a blood     vessel). A new analytical model of FFR from the general Bernoulli equation (conservation of     energy) (FFRB) is simple and has potential. A collaborator group has recently developed a new     analytical model to quantify pressure drop, and hence FFR, based on lesion dimensions (i.e.,     the cross-section area along the lesion and the length of lesion) and coronary flow, with no     empirical parameters. The investigators hypothesize that this new model will allow     quantification of FFR (FFRB) in a cohort of human patients with intermediate coronary     stenosis. The study will compare FFRB with invasive FFR measurements from invasive coronary     angiography (ICAG).   "
17663|NCT03054311|"     Lifestyle Matters is an occupational approach to healthy ageing, which helps older people to     get the most out of life. The intervention is based on an American model of health promotion     called Lifestyle Redesign. This was found to be highly effective in enhancing the physical     and mental health, occupational functioning and life satisfaction of community living older     adults in Los Angeles, USA.      Weekly group meetings provide older people with the space, time and opportunity to share     their experiences. Through a process of peer exchange and guidance, participants have the     opportunity to reflect upon the range of activities that they engage with. They are then     helped to begin to understand how these activities might impact on their health and     well-being. However this approach alone cannot meet the complex needs of individual older     people, and their specific and personal concerns. In recognition of this, the programme also     includes monthly individual sessions with one of the group facilitators. The older person in     partnership with the facilitator identifies a tailored programme to meet their individual     needs, including the means by which they might work towards their personal goals. The     individual programme is updated and refreshed in subsequent meetings over the months.      During 2004/5 researchers at Sheffield Hallam University in partnership with other     researchers in York and Leeds, and clinical colleagues in Sheffield explored the feasibility     of delivering this intervention to older people living in the UK. The project was funded     through the Sheffield Health and Social Research Consortium. The summary below is an account     of the process and outcomes of delivering a Lifestyle Matters programme to two groups of     community living older people during 2004/5.   "
17664|NCT03054298|"     Phase I study to establish safety and feasibility of intravenous or intrapleural administered     lentiviral transduced huCART-meso cells with or without lymphodepletion. Intravenous     administration of huCART-meso cells is planned with or without cyclophosphamide as     lymphodepleting chemotherapy.   "
17665|NCT03054285|"     The primary objective of this study is to prospectively assess in randomized fashion whether     short term anti-seizure prophylaxis in traumatic brain injured patients decreases the     incidence of seizures in the early post-injury period. A secondary objective is to evaluate     whether there are differences in mortality, hospital length of stay, functional outcome at     hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for     patients who receive and do not receive anti-seizure prophylaxis.   "
17666|NCT03054272|"     Using eye-tracking technology, the aim of this observational study is to compare the visual     interests between attending physicians and residents watching a Cannot Intubate/Cannot     Oxygenate (CICO) scripted and simulated scenario   "
17667|NCT03054259|"     This is a feasibility study to test a new trial design for an important drug in Systemic     Lupus Erythematosus (SLE or lupus).      SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of     the body may be affected, but most commonly lupus causes a rash and arthritis, this affects     patients' quality of life.      Lupus is usually treated with steroids or drugs that suppress the immune system. Although     these help, many patients don't respond well enough and there is also concern for long term     side effects. There is a new type of treatment called biologics. These target individual     cells or molecules rather than the whole immune system and may be more effective with fewer     side-effects. B cells are a part of the immune system that are known to play a role in lupus.     There is already a biologic that removes these, called rituximab. In rheumatoid arthritis and     vasculitis (similar to lupus), rituximab has been proven to be effective in clinical trials.     However, in lupus clinical trials it did not seem to show any benefit. But many doctors and     patients found that rituximab is effective, but the trials couldn't show this because of the     way the drug's effects were measured. Therefore it is important that we test whether it truly     is effective for lupus.      In this 6 month clinical study the investigators will look at lupus patients who have skin     disease and arthritis as these are very common and randomise them to receive either rituximab     or a placebo. Patients will have a careful clinical examination and undergo different methods     to measure the effectiveness of the treatment. There are new versions to rituximab called     biosimilars. In this study biosimilar GP2013 will be used.      If this trial is successful a larger definitive study will be designed based on its results.   "
17668|NCT03054246|"     The study is aimed to investigate if chewing side preference (CSP) can be used as another     indicator of hemispheric laterality in healthy adults. Healthy volunteers with no oral/dental     problems with Angle I occlusion relationship and without any missing teeth will be included     in the study. The CSP will be determined with the visual analog scale (VAS), which is the     highly reliable method. Laterality test will be used to determine the preferred side for     hands, feet, ears and eyes.   "
17669|NCT03054233|"     The study aimed to compare successful spinal needle insertion between obese and non-obese     pregnant women in crossed leg sitting position undergoing cesarean section   "
17682|NCT03054064|"     The purpose of this study is to evaluate the safety and effectiveness of the Indego     exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular     Accident (CVA).   "
18028|NCT03049553|"     In Denmark, the first birth cohorts of women offered HPV-vaccination as girls are entering     the cervical screening program. These women are expected to be better protected against     cervical cancer. It has not yet been decided how to screen these women.      This method study will investigate a possible screening scheme that could provide a reduced     burden of screening for HPV-vaccinated birth cohorts.   "
17670|NCT03054220|"     CYP2D6 is characterized by a huge variability in the general population, mainly because of     genetic polymorphism and drug-drug interactions (DDIs). CYP2D6 genotype is known to have an     impact on the extent of DDIs. Indeed several studies have pointed out differential DDIs     extent according to CYP2D6 genotype. The terms phenoconversion and phenotype switch are both     used to describe the phenomenon by which a given subject changes his phenotype to another due     external influence such as DDIs. When given a sufficiently strong CYP2D6 inhibitor, the     phenotype of an individual with no mutant allele (extensive metabolizer, EM) of CYP2D6 can be     modified to a poor metabolizer (PM) phenotype. This vulnerability is also thought to be     dependent on CYP2D6 genotype. Various combinations of alleles predict an EM genotype, which     represents about 60 to 70% of the general population. The aim of the study is to determine     whether the presence of genetic mutation in CYP2D6 has an impact on DDIs involving the CYP2D6     enzyme. Our interest focuses on CYP2D6 EM carriers of two fully functional alleles and     carriers of one non-functional and one functional allele. In order to elucidate this     question, CYP2D6 activity will be measured on healthy volunteers by administration of single     low doses of dextromethorphan and tramadol in presence or not of duloxetine and paroxetine,     two known CYP2D6 inhibitors.   "
17671|NCT03054207|"     HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit     multiple risk factors by the nature of their pathology. In addition, the long term exposition     to antiretroviral drugs has been associated to an increased risk for CVD. HIV patients can     thus potentially receive antiplatelet therapy concomitantly with their antiretroviral     treatment. Clopidogrel and prasugrel are thienopyridine antiplatelet agents indicated to     prevent the recurrence of ischemic events after coronary arteries stenting. These pro-drugs     are mainly bioactivated by cytochromes P450 (CYP) 3A and 2B6 for prasugrel and CYP2C19, CYP3A     and CYP2B6 for clopidogrel. Ritonavir is commonly used to boost the bioavailability of     other HIV drugs through inhibition of CYP3A4 as well as CYP2B6 and CYP2C9. This interaction     could therefore reduce clopidogrel and prasugrel efficacy by reducing the formation of their     active metabolites. The aim of the present study is to assess the potential drug-drug     interaction between clopidogrel/prasugrel and ritonavir. Two groups of 12 male subjects will     be constituted (12 HIV patients under ritonavir boosted therapy and 12 healthy volunteers) in     a randomized cross-over clinical trial. All subjects will also be genotyped for the CYP2C19.     The pharmacokinetics of clopidogrel active metabolite and prasugrel active metabolite will be     assessed. Furthermore, the pharmacodynamic response will be evaluated by two gold standard     platelet inhibition tests, namely VAsodilator-Stimulated Phosphoprotein Assay (VASP) and     VerifyNow® assays. The primary endpoint of this study is to compare the pharmacodynamic     response to clopidogrel and prasugrel in HIV patients to that of healthy volunteers.   "
17672|NCT03054194|"     Study E2730-A001-001 is a first-in-human, sequential ascending single dose,     placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a     single oral dose of E2730 in healthy participants.   "
17673|NCT03054181|"     Long-term observational study on the utilisation and outcomes of HyQvia (a product consisting     of recombinant human hyaluronidase and a human normal immunoglobulin 10% solution) under     everyday clinical practice conditions.   "
17674|NCT03054168|"     This study evaluates the effect of increase in testosterone levels in older males and the     effects of decrease in testosterone levels in young males on muscle protein synthesis.   "
17675|NCT03054155|"     Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated     on one side with the Alexandrite hair removal laser. The other side will serve as the     control.   "
17676|NCT03054142|"     Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the hospital.     AKI has become a huge medical burden in China. Little information is available about this     disease burden in our country. The investigators aimed to evaluate the burden of AKI and to     analyze the related risk factors.   "
17677|NCT03054129|"     The purpose of the study is to determine whether balance training is effective in patients     with rotator cuff disease.   "
17678|NCT03054116|"     In a prospective, observational study the investigators compared resistance values measured     using the airway perturbation device (APD) to impulse oscillometry and spirometry. The     investigators also created reference equations for normal APD resistance ranges using the     data from clinically normal volunteers.   "
17679|NCT03054103|"     Background: Phacoemulsification is the most common surgical procedure performed in the United     States and European Union and sedation is commonly used during phacoemulsification to help     alleviate patient anxiety and prevent the patient from interfering with the procedure. The     investigators have administered ketamine in addition to midazolam in this regard. To study     the effectiveness of this technique, The investigators proposed a study to determine if     adding low-dose ketamine to midazolam has any beneficial (or negative) effects on operating     conditions, patient satisfaction, and recovery during and after unilateral     phacoemulsification procedures performed using topical anesthesia and intravenous (IV)     conscious sedation.      Methods: In a free-standing Outpatient Surgery Center, the investigators conducted a     randomized, double-masked, 3-arm, prospective comparison of IV midazolam only vs. midazolam     with ketamine 5 mg IV vs. midazolam with ketamine 10 mg IV. The investigators then measured a     single surgeon's assessment of surgical conditions, self-reported patient satisfaction,     postoperative pain score, and duration of postoperative stay. The investigators also analyzed     the dose of midazolam required to meet subjective anxiolysis in each group.   "
17680|NCT03054090|"     Most care for chronic conditions is provided by primary care clinicians. Although Virginia     ranks 4th among the 50 states in average income, it ranks 27th in mortality due to heart     attacks and strokes. The scope and focus of this project will materially improve the rates of     screening and treatment of risk factors for heart attacks and strokes, and will give primary     care clinicians the tools and training to improve the care of other chronic illnesses and the     delivery of preventive services.   "
17681|NCT03054077|"     This is a small pilot, feasibility study designed as a quality improvement project. The     purpose is to identify anxiety in children aged 4-12 years who will receive a sedated     procedure and to see if the use of an iPad as a focused activity will decrease the level of     anxiety through a small randomized control trial in the Children's Perioperative Unit.   "
20234|NCT03020706|"     The purpose of this study is to evaluate the effect of magnesium sulphate on     neostigmine-induced reversal of neuromuscular block by rocuronium   "
17683|NCT03054051|"     This project will test the feasibility of an electronic game to prevent HIV among African     preadolescents, delivered via inexpensive Android smart phones. In order to collect     feasibility data for a future randomized controlled trial, this study involves the     pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya,     where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be     carried out with the Kenya Medical Research Institute (KEMRI).   "
17684|NCT03054038|"     This phase I trial studies the side effects and best dose of afatinib and necitumumab and to     see how well they work in treating patients with EGFR mutation positive non-small cell lung     cancer that has spread to other places in the body. Afatinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving     afatinib and necitumumab may work better in treating patients with EGFR mutation positive     non-small cell lung cancer.   "
17685|NCT03054025|"     This pilot clinical trial studies how well a smart phone application works in increasing     physical activity in breast cancer survivors. A smart phone application that increases     physical activity may help reduce the likelihood of cancer coming back in breast cancer     survivors.   "
17686|NCT03054012|"     Background:      Functional and aesthetic reconstruction of mandibular defects due to tumour invasion,     osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good     anatomic and symmetric reconstruction with stable occlusion and condylar position.     Classically this was obtained by (pre)bending a reconstruction plate, and providing     osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM     software enabling a preoperative planning based on 3D models. This computer-assisted surgery     (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce     ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as     well as the effective reduction in operating time and financial implication.      Study design:      Retrospective study.      All patients undergoing bony reconstruction by free vascularised flap between January 2013     and August 2016 will be included. Accuracy will be measured between the planned and actual     result, through segmentation of the mandible in Brainlab software. Parameters regarding     ischemic time and financial cost will be obtained from the medical files.   "
17687|NCT03053999|"     The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH)     who undergo surgery.   "
17688|NCT03053986|"     Apple polyphenols are mostly acknowledged for their hypoglycaemic properties, but represent     an apple active fraction with many pharmacological functions. The study aim was to examine     their effect on uricemia and endothelial function in a sample of overweight subjects. This     was a two-phases study. The in vitro experiment aimed to evaluate the apple polyphenols'     ability to lower uric acid in comparison with allopurinol. The in vivo study consisted in a     randomized, double-blind, parallel placebo-controlled clinical trial involving 62 overweight     volunteers with suboptimal values of fasting plasma glucose (100 mg/dL≤FPG≤125 mg/dL),     randomized to be treated with 300 mg apple polyphenols or placebo for 8 weeks.   "
17689|NCT03053973|"     Rationale:      Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary     disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been     shown to improve outcomes. However, the mechanism behind these improvements are unknown. We     hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and repair     pathways in patients with COPD. In the present study we aim to investigate, in COPD patients     with CHRF,        1. change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as          compared to standard care        2. the relationship between FEV1 change and modification of systemic and airway          inflammation and remodelling, lung hyperinflation, and airway morphology.        3. predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study          design: multicentre randomised controlled study investigating the effects of NIV on          airway morphology, airway inflammation and remodelling in hypercapnic COPD patients          including a control group that will postpone the initiation of NIV for 3 months. In          addition we will investigate how patient demographics, patient and disease          characteristics and systemic and airway inflammation predict the response to chronic NIV          in severe stable COPD. To do this, all patients will be followed for 6 months after NIV          initiation.      Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months.     Furthermore, as we recognise that FEV1 might not be the most important patient-related     outcome, we will assess which parameters affect health-related quality of life after 3 and 6     months.   "
17690|NCT03053960|"     This clinical trial studies how well helical computed tomography (CT), positron emission     tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography     (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw     bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI,     and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence or     absence of jaw invasion may help create a better surgical treatment plan for patients with     oral cancer.   "
17698|NCT03053856|"     This is a single arm, single center phase II study of adjuvant pembrolizumab in N2 positive     non-small cell lung cancer (NSCLC) patients treated with neoadjuvant concurrent     chemoradiotherapy followed by curative resection. Patients will receive pembrolizumab 200 mg     every 3 weeks for up to 24 months.      The primary objective of this study is to assess the efficacy of adjuvant pembrolizumab     treatment in terms of disease-free survival (DFS; per Response Evaluation Criteria In Solid     Tumors (RECIST) 1.1 as assessed by the investigator).      The baseline assessment is part of the screening procedures and should be performed within 0     to 14 days before the start of study drug. The imaging modalities used for RECIST 1.1     assessment will be CT of chest or PET-CT if indicated. Follow-up chest CT for all patients     will be assessed every 12 weeks for the first year, every 16 weeks for the second year, every     6 months for the third year, and every year thereafter. In subjects who discontinued study     therapy without documented recurrence, every effort should be made to continue monitoring     their disease status.      If an unscheduled assessment is performed, and the patient has not progressed, every attempt     should be made to perform the subsequent assessments at their scheduled visits. RECIST 1.1     scans will be analyzed by the investigator on site; a central review will not be conducted.      Following completion or discontinuation of study drug, patients will enter a follow-up     period.      Once a patient has had objective relapse recorded and has discontinued study drug, the     patient will be followed for survival status every 3 months until death, withdrawal of     consent or the end of the study.      Patients will also be requested to provide tumor samples from diagnostic (obtained before     neoadjuvant CCRT) and surgical specimens for exploratory biomarker study. Sample provision is     not optional, subject to a specific consent.   "
35483|NCT02821351|"     The primary objective of this study is to establish the safety and performance effectiveness     of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic     paroxysmal atrial fibrillation (PAF).   "
17691|NCT03053947|"     Lacerations are one of most common trauma in children presenting to the emergency department     (ED). Currently, there are wide variations regarding sedation and analgesia practices when     suture are required. Even though topical anesthesia is very useful to reduce pain, it does     not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing     laceration repairs in the ED.      There is a growing interest in the intranasal (IN) route of administration in the pediatric     population. It bypasses the first hepatic passage and thus provides medications direct access     to the systemic circulation leading to higher and faster serum concentrations than would the     oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated     with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two     agents that can be combined for this procedure, but respiratory depression is a feared     adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can     offer potent analgesia and sedation while maintaining respiratory drive and protective airway     reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide     range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest     possible dosage that can be used to successfully repairs laceration in children with minimal     restrain and no adverse events, as described by the Pediatric Emergency Research Canada     (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.   "
17692|NCT03053934|"     The objective of the study is to establish whether online video counselling is at least     equally acceptable and equally as effective to clients and clinicians of the Veterans and     Veterans Families Counselling Service (VVCS) as in-person counselling. If this is confirmed     by the evaluation then online video counselling can be made more widely available to support     the veteran and ex-service community, especially for those who may otherwise be unable to     attend therapy and for clients who would prefer such web-based services over in-person     sessions.   "
17693|NCT03053921|"     Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally     advanced flap in covering single and multiple Miller's class I and II gingival recession     defects.   "
17694|NCT03053908|"     Alzheimer's disease (AD) is a common neurodegenerative disease characterized by the     accumulation of amyloid plaques and neurofibrillary tangles. Current consensus is that the AD     pathological process begins decades before clinical symptoms occur. This long preclinical     phase of AD might first become detectable in middle-age as deposits of hyperphosphorylated     tau (P-tau) in the transentorhinal cortex and subcortical nuclei such as the locus coeruleus     (LC) and the nucleus basalis of Meynert. There is strong preliminary evidence showing that     cerebrospinal fluid (CSF) levels of orexin-A (OxA) are associated with increased P-tau     (r=.52, p<.01) and total-tau (T-tau) (r=.42, p<.01) in cognitively normal older adults (mean     age: 69.6±8.6 years).      This study poses that onset of tauopathy in the LC results in down regulation of orexin     receptors, leading to a homeostatic increase of OxA production by the hypothalamus, which     results in changes in core body temperature (CBT) and sleep disruption that cause further     neurodegeneration. This hypothesis will be tested by demonstrating that increases in CSF     P-tau are associated in vivo with tau PET uptake, and that tau binding in the LC is     associated with increases in CSF OxA (Aim 1); and second, by analyzing the downstream     consequences of increased central nervous system (CNS) OxA on sleep architecture and CBT (Aim     2). To test these hypotheses, 30 older adults (age 55-75) balanced by sex, will first perform     a full clinical evaluation and MRI (visits 1-2). Subjects will later undergo 7 days of     actigraphy followed by nocturnal polysomnography (NPSG) for 2 consecutive nights (N1-2)     during which we will measure CBT (visits 3-4). A morning lumbar puncture (LP) will be     performed after N2 to obtain CSF. Tau burden will be analyzed by PET-MR using 18F-THK5351,     which will be performed 1-4 weeks after the LP (visit 5).   "
17695|NCT03053895|"     DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)      CSDH is an abnormal collection of blood between the layers of the brain causing brain tissue     compression leading to neurological complications. One of the most common risk factors     contributing to CSDH is head trauma, which is usually in the form of a minor head injury.     Older individuals are at increased risk of CSDH due to brain atrophy that occurs with     advancing age as well as their tendency to fall and sustain minor head traumas. Chronic     alcoholics are also at increased risk as alcoholism also leads to brain atrophy, increased     risk of falls, and liver failure which results in increased bleeding risk. Also many drugs     used today like anticoagulants, antithrombotics, and antiplatelets for certain health     conditions are other common risk factors for CSDH.      The overall goal of this multi-centered trial in the USA and Canada is to assess the surgical     management of chronic subdural hematoma (CSDH) and to demonstrate the effectiveness of     bedside drainage and its safety as it bypasses the perioperative risk associated with     anesthetic especially among the elderly.      Adult patients with a clear indication for CSDH drainage will be randomly assigned to one of     two procedures. One group will receive the twist drill procedure which can be performed at     the bedside. The second group will undergo the burr-hole drainage procedure in the operating     room usually under general anesthetic. Typically, the twist drill procedure can occur sooner     as the operating room and Anesthetist are not required. Reoccurrence of the CSDH will be     assessed over a period of 6 months following drainage. Timing of procedure, risk of     infection, adverse side effects and neurological functioning will also be measured.      Over a 3 year study period, 486 eligible patients (243 patients per arm) will be enrolled.     Patients > 18 years with confirmed diagnosis of symptomatic CSDH will be provided one of the     two procedures and will be followed for study outcomes at 1, 3 and 6 months following the     procedure.      Primary analysis will be to compare the surgical procedures, assessing the recurrence rate of     CSDH within 6 months of initial CSDH drainage.      The ultimate goal of this study is to standardize bedside drainage as the treatment of choice     for CSDH management.      This trial is important in the ongoing search for more efficient and safe intervention     strategies.   "
17696|NCT03053882|"     Background:      Herbal remedies can have the role of prevention and control of bad breath Since in the     previous studies, therapeutic and antibacterial effect of green tea and peppermint had been     proven .we studied and compared the effects of green tea and peppermint mouthwashes on     halitosis.      Materials and Methods:      This single-blind clinical trial study with cross over design total of 88 volunteer dental     students who complained bad breath and had organoleptic score (>= 2) and higher average test     scores were enrolled. The students were divided randomly into two groups Green Tea -     Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21 measured     after rinsing the mouthwashes .As well as the satisfaction of both plants on the last day was     considered. Data analysis was performed using tests; Wilcoxon signed rank test, Mann Whithney     u, GEE (Generalized Estimating Equation -ordinal logistic regression).   "
17697|NCT03053869|"     The purpose of this research study is to find out if a cardiac anesthesia policy that uses     alternatives to benzodiazepine medications is better at preventing delirium after cardiac     surgery when compared with a cardiac anesthesia policy that uses benzodiazepine medications.   "
17710|NCT03053700|"     This is an interventional and prospective study. The study is designed to evaluate the     additional benefits of a combination of IPL treatment and local application of Bromonide     0.33% gel in the treatment of erythematotelangiectatic (ETR) and papulopustular (PPR).   "
18029|NCT03049540|"     This study assesses in a double-blind, randomized, placebo-controlled multi-center pilot     trial the effect of PDE-5 inhibition with Tadalafil on right ventricle size and function,     exercise capacity and neurohumoral activation in adults with congenital heart disease and a     right ventricle in subaortic position over a 3-year follow-up period.   "
17699|NCT03053843|"     Background: Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and represents a     high priority public health problem, as in a few decades it will become a possibly     unsustainable load for the national health system. Preventive and therapeutic strategies     based on the best possible scientific evidence are required. Ablation therapy, despite being     the most effective approach, is associated with a 30-35% arrhythmic recurrence rate. An     intervention with Mediterranean diet and extra virgin olive oil (EVOO) has proven effective     in primary prevention and reduced the incidence of AF in high-risk subjects in a recent,     large, randomized trial (PREDIMED).      Methods: Parallel, randomized, multicenter nutritional intervention trial in 640 patients     with AF treated with catheter ablation. Two groups will be randomized in a 1:1 ratio: 1)     intervention with Mediterranean diet and EVOO; 2) usual care (control group). The primary     objective will be the incidence of atrial tachyarrhythmias for two years after ablation. At     least 190 recurrences are expected after 2 years (median) of follow-up. A relative risk of     0.7 is assumed and statistical power of 80%. Follow-up visits will be scheduled at 3, 6, 12,     18 and 24 months. In addition to the in-person visits, event monitors will be used to     document episodes. Dietary intervention will be carried out by nutritionists who will use     methods adapted from the PREDIMED trial with contacts every 2 months. 1 liter of EVOO per     week will be provided for free in the intervention arm. Inflammatory markers will be analyzed     in both groups during follow-up. Cox models will be used to estimate adjusted hazard ratios.   "
17700|NCT03053830|"     Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to     6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will     occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer     term effects of ketamine.   "
17701|NCT03053817|"     Exercise programs that combine resistance exercise with aerobic training yield optimal health     benefits for people with HIV. The global aim of this study is to contribute evidence for the     impact potential of a comprehensive exercise program on brain health in people with HIV.      This study is part of a larger project based upon a cohort multiple randomized controlled     design. Within a fully characterized cohort which is followed over time, people meeting the     specific criteria for an exercise intervention will be identified. The sample will be     randomly selected to receive the intervention; the remaining eligible persons will serve as     controls. The intervention group will receive a 45 minute structured exercise program 3 times     a week consisting of aerobic exercise and resistance training for a total of 12 weeks.   "
17702|NCT03053804|"     It is a study that hypothesize that MR/PET can have better information than current CT image     study, about the medical or surgical treatment outcome of lung cancer   "
17703|NCT03053791|"     Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the spinal     cord at the injury site. Of the 60% functionally incomplete patients, about half face a life     in the wheelchair. Besides conventional rehabilitation, no prominsing further treatment     options exist. One of the most plastic systems involved in locomotion is the pontomedullary     reticulospinal tract, which is the oldest locomotor command system existing in most     vertebrates, including primates. Muscle activation patterns for limb movements are programmed     in the spinal cord and have to be activated and coordinated through commands from the so     called mesencephalic locomotor region (MLR). The MLR consists of nerve cells in the lower     mesencephalic tegmentum sending uni- and bilateral signals through the medullary     reticulospinal tracts. Classical physiological studies showed that electrical stimulation of     the MLR induce locomotion. For the first time this approach was transferred and recently     published in a model of induced incomplete spinal cord injury by the Schwab group. Rats     severly impaired in motor hindlimb control with only 10-20% spared white matter, recovered     with fully functional weight bearing locomotion under MLR deep brain stimulation (DBS). Even     rats with only 2-10% spared white matter regained weight supporting stepping. DBS is a     clinical standard treatment option in patients with movement disorders but does not relieve     all symptoms. Therefore, small studies of MLR stimulations have been safely used in     Parkinsonian patients showing freezing of gait and frequent falls with variable results. In a     translational approach, we aim at performing a multidisciplinary phase one clinical trial     with 5 patients and incomplete spinal cord injury. With the means of our established     universitary setup for DBS treatments the operations will be performed unilaterally under     local anaesthesia in the Division of Neurosurgery, USZ, with perioperative     electrophysiological recordings, clinical assessments and gait analysis under test     stimulation in the Spinal Cord Injury Center Balgrist.   "
17704|NCT03053778|"     This study aims to explore and reduce readmission rates, while improving health-related     quality of life through patient-reported outcomes (PROs) and after Heart Valve Surgery. This     will be investigated through surveys and by a trial investigating the effect of an early     rehabilitation effort in a Heart Valve Clinic format.   "
17705|NCT03053765|"     The study is designed to develop and validate an instrument to measure quality and adherence     to IPT for research and training purposes. The measure is now being used to evaluate training     in IPT.   "
17706|NCT03053752|"     Sleep disorders are among the non-motor signs more common in Parkinson's disease (PD). This     case series evaluated the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on     acupoints in the self-assessment of sleep in 14 PD patients classified between stages 1 and 3     of Hoehn and Yahr original (HY). Patients were assessed using the Sleep Scale for Parkinson's     Disease (PDSS) and subjected to treatment with eight TENS sessions on acupoints, with the     current Burst. We used the paired sample t-test, considering p ≤ 0.05.   "
17707|NCT03053739|"     The study will be carried out on 50 consecutive consenting patients of systemic sclerosis     with PAH recruited from outpatient department of internal medicine and rheumatology clinic of     PGIMER, Chandigarh, India It is a single centre double blind randomised controlled trial     evaluating the effect of upfront dual therapy (sildenafil and bosentan) vs monotherapy     (sildenafil) Participants will be randomised in 1:1 ratio to one of treatment arms. Placebo     and PDE-5 inhibitors 20 mg BD to 60 mg if patient tolerates the drug well to one study arm     and PDE-5 inhibitors plus ER antagonist 62.5 to max of 125 to other study group   "
17708|NCT03053726|"     In the VFS paradigm the stimulation frequency was set to alternate between high and low     frequencies, where the frequency of stimulation or frequency combinations can be changed     instantaneously according to damage of the moment rhythms. Variable frequency stimulation is     a novel dynamic therapy which breaks through the existing single high-frequency stimulation     paradigms. It is the world's first VFS therapy for the brain.   "
17709|NCT03053713|"     The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the     intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of     this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and     the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to     determine if the MDP results in changes to the intestinal bacteria or immune system.   "
17711|NCT03053687|"     The Proposed study is a double blind, randomized, placebo controlled study The aim of the     study is to evaluate the effect of combined Growth Hormone (GH) treatment & nutritional     formula supplementation versus GH & placebo on growth parameters in 64 children with Isolated     Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment.      In this trial GH is a background treatment (non-investigational medicinal product.     Participants may be treated with any of the commercial GH products approved in Israel for the     indication of IGHD.      Participants will be randomly assigned either to the intervention group or the placebo     control group. Randomization for the two study groups will be made in a ratio of 1:1. Both     participants and study team will be blinded to the type of treatment that each patient will     receive during the study. The randomization will be done according to gender and tanner     stage.      Participants in the intervention groups will be treated with the study formulas and     participants in the control group will be treated with a placebo low caloric formulas (Powder     added to water) The study will continue for 6 months of intervention versus active placebo,     with additional 6 months (an extension period), in which participants at both groups, the     intervention and the placebo, will be offered to continue their participation in the study     with the active study supplement.   "
17712|NCT03053674|"     The aim of this study is to determine whether an explanation to parents for the need for     post-partum influenza vaccination will influence their compliance.   "
17713|NCT03053661|"     The IRECT trial is a non-interventional, prospective clinical trial using modern immune     monitoring techniques over the course of the standard of care for HNSCC. The dynamics of     host/tumor immune interactions during the conventional standard treatment will be analyzed to     find the most promising target antigen and to develop a strategy how and when specific     immunotherapy should be added to the current treatment schedule.      The results from this trial will help to understand how state of the art treatment can be     complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to     improve the outcome of head and neck cancer patients.   "
17714|NCT03053648|"     Abstract      Objectives: To explore the clinical effects of self-acupressure for treating insomnia     delivered by a training course.      Hypothesis: Subjects who have participated in the self-acupressure training course will have     greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene     education control group at 4 and 8 weeks.      Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be     recruited from the community. 30 subjects will be randomized to self-acupressure and sleep     hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index     (ISI) will be used to assess insomnia symptoms and daytime impairment.      Interventions: Subjects in the self-acupressure group will attend two training sessions to     learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects     in the sleep hygiene education control group will receive two training sessions to learn     sleep hygiene practice.      Main outcome measures: The primary outcome measure is the ISI score. Other measures include     sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and     SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be     evaluated.      Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be     examined using a mixed-effects model.   "
17715|NCT03053635|"     This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects     with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy     will be eligible for participation in the study. BCG intolerance or refractory disease are     defined as inability to tolerate or failure to achieve a tumour-free state after at least one     induction (a minimum of 5 instillations) followed by either a second induction (a minimum of     5 instillations) or at least 2 maintenance instillations. Subjects experiencing disease     relapse within 12 months or less after finishing the second course of BCG therapy are also     considered refractory. The study will consist of 2 phases. In the first phase, 3 subjects     will receive PDT (TLC-3200 System) employing 0.35 mg/cm^2 (maximum recommended starting dose)     TLD1433. If treatment with the maximum recommended starting dose does not raise significant     safety concerns as determined by the safety monitoring committee, an additional 6 subjects     will receive PDT with 0.70 mg/cm^2 (therapeutic dose) TLD1433.   "
17716|NCT03053622|"     This study is conducted to compare how much mirikizumab, in two different formulations, is     absorbed into the bloodstream and how long the body takes to get rid of it, when given as an     injection under the skin or into the veins. Side effects of the injection will be collected.     Each participant will be in the study for about 18 weeks, including screening.   "
17717|NCT03053609|"     Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal     Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge.      Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the     temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events     in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms and,     whether this association is significant, to clarify the impact of GER on CR events.   "
17718|NCT03053596|"     The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety     of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable     hepatocellular carcinoma allocated to TACE treatment.   "
17719|NCT03053583|"     The purpose of this study is to compare straight blades in obtaining best glottic view in     children. The investigators will compare size 1 Classical Miller, size 1 Wis-Hipple, and size     1 C-MAC straight blades in young children.   "
17720|NCT03053570|"     The purpose of this study is to perform a prospective, randomised study investigating the     safety and efficacy of cryoballoon catheter ablation compared with radiofrequency     ablation(contact force), in the treatment of persistent AF.   "
17745|NCT03053245|"     The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative critical     care recovery program from acute respiratory failure (ARF) survivors in accomplishing the     Institute of Healthcare Improvement's triple aims of better health, better care, at lower     cost.   "
18170|NCT03047694|"     Lexical semantic disorders are described in Alzheimer's disease, and their incidence in     everyday life is important to the extent that these disorders affect expression and     comprehension.      Providing a tactile tablet stimulation, independent and complementary to speech therapy,     could help to maintain certain abilities and reinforce the feeling of autonomy of the     patients.   "
17721|NCT03053557|"     This study aims to test a new device called the Social Skills Coach that is being created to     help mental health consumers with social skills and community functioning. People diagnosed     with schizophrenia and clinicians will be included as participants in this study. Mental     health consumers (diagnosed with schizophrenia) will be randomly assigned to either test the     new device or to participate in a social skills training course. Data will be collected from     participants through surveys before participants either use the device or participate the     course and afterwards. Individual interviews will be conducted with a sub sample of mental     health consumers and clinicians. The study looks to test the credibility and acceptability of     the new device to help mental health consumers and clinicians. it will also influence future     research.   "
17722|NCT03053544|"     This study is a phase II, single arm, controlled, open label internal pilot.   "
17723|NCT03053531|"     The Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot), gathers     preliminary data and hones procedures and measures, prior to undertaking HERO-ED. Since the     HERO-ED Pilot does not involve random assignment (no control group), it will not test device     effectiveness. However, the HERO-ED Pilot will test device acceptability and use. It will     also provide preliminary data on, and allow us to fine-tune, the measures of effectiveness     that we plan to use in HERO-ED   "
17724|NCT03053518|"     This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a     North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage,     single-group feeding study in 20 individuals, including 10 participants managed with     lifestyle alone, and 10 managed with lifestyle plus metformin.   "
17725|NCT03053505|"     This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial     with randomized and non-randomized study groups to evaluate the safety and effectiveness of     faecal microbiota transplantation (FMT) for the treatment of adult patients suffering from     primary or recurrent Clostridium difficile infection (CDI), using a novel, standardized     microbiota transplantation system.   "
17726|NCT03053492|"     This study has 2 parts: In one part of this study, people with stroke will either play a     custom designed computer game for stroke rehabilitation called Duck Duck Punch or an off the     shelf computer game with their weaker arm 3 times per week for 6 weeks. Evaluations will     determine whether or not one computer game improved arm movement more than the other. In the     second part of the study, people with stroke, caregivers of people with stroke and stroke     rehabilitation therapists will meet in several focus groups to design a useful and     informative Duck Duck Punch performance report.   "
17727|NCT03053479|"     Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very     little is known about the factors associated with surgical failure. Studies have identified a     variety of risk factors: younger age, high body mass index and advanced preoperative prolapse     (grade III-IV) have been associated with an increased risk of reoperation in some studies.     According to some studies patients had poorer anatomical outcome after traditional repairs     but were able to enjoy the same quality of life as after transvaginal mesh surgery or     laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy     of these three procedures in a randomized controlled trial.   "
17729|NCT03053453|"     The purpose of this study will be to evaluate and compare patients undergoing total knee     arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient     will be assessed for the difference between passive, soft tissue controlled, pressure balance     and muscle activated pressure balance.   "
17730|NCT03053440|"     This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib     in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.   "
17731|NCT03053427|"     The objective of this study is to assess the efficacy of once-daily oral administration of     Gabapentin enacarbil versus placebo, based on the change in International Restless Legs     Syndrome Rating Scale (IRLS) score in subjects with moderate-to-severe primary Restless Legs     Syndrome. This study will also assess the safety of Gabapentin enacarbil.   "
17732|NCT03053414|"     Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease     (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is     thought to result from a complex interaction between genetic, immune, microbial and     environmental factors. There is emerging data suggesting Vitamin D may not only play a role     in bone health but may also be involved in gut health as well. While there are guidelines     regarding the recommending doses of Vitamin D for supplementation and maintenance in bone     health, these strategies are unknown in those with inflammatory bowel disease. The     investigators seek to determine a dosing strategy for this population using doses within the     recommended guidelines for bone health.   "
17733|NCT03053401|"     Both Ultrasound guided Adductor Canal Block ( ACB) and Femoral Nerve Block (FNB) has been     used to provide postoperative analgesia for knee surgeries. To the investigators' knowledge,     no comparison has been made between these blocks in relation to postoperative quadriceps     muscle strength, or duration and quality of postoperative analgesia for arthroscopic ACL     repair in pediatrics. If ACB provides postoperative analgesia after arthroscopic knee surgery     comparable to FNB, it has the potential to improve the postoperative outcome as it will lead     to less quadriceps muscle weakness and early mobilization, both of which are very important     in the early postoperative period.   "
17734|NCT03053388|"     Double blind, randomized multi-center, evaluation of the efficacy, safety and tolerability of     Nitric Oxide (NO) given intermittently via inhalation to subjects with acute bronchiolitis.      Bronchiolitis is defined as an infection of the small airways. It is also the most common     manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the     leading cause of global child mortality.      Nitric Oxide (NO) has been shown to play a critical role in various biological functions,     including in the vasodilatation of smooth muscle, neurotransmission, regulation of wound     healing and during immune responses to infection with a microbicidal action directed toward     various organisms. In the airways, NO is considered to play a key role in the innate immune     system in which the first-line of host defense against microbes is built.      The beneficial effect of NO has been shown in different diseases with several options of     doses and regimens; newborn with primary pulmonary hypertension showed improvement in     oxygenation after 30 minutes of NO treatment at 10-20 ppm, while subjects with adult     respiratory distress syndrome demonstrated clinical improvement during NO treatment at 18 and     36 ppm.      In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses     antimicrobial and anti-viral activity against a wide variety of phyla including bacteria,     viruses, helminthes and parasites.      Safety and tolerability of 160 ppm NO given intermittently via inhalation were shown in a     phase II study performed on 2-12 month infants hospitalized with bronchiolitis. According to     data no difference in the proportion of adverse events and serious adverse events were     detected between subjects treated with NO and subjects treated with standard supportive     treatment.      In this study the investigators wish to assess the efficacy of 160 ppm NO given     intermittently via inhalation to 0-12 months-old infants hospitalized due to acute     bronchiolitis.      Primary objective: Asses the difference in hospital Length of Stay (LOS) between subjects     treated with 160 ppm NO combined with standard supportive treatment and subjects treated with     standard supportive treatment.      Secondary objectives: Asses the difference in the time required to achieve clinical     improvement, a clinical score ≤5 (Modified Tal score) between subjects treated with 160 ppm     NO combined with standard supportive treatment and subjects treated with standard supportive     treatment. Assess the difference in the time required to achieve sustained 92% oxygen     saturation in room air between subjects treated with 160 ppm NO combined with standard     supportive treatment and subjects treated with standard supportive treatment. Characterize     the safety and tolerability of 160 ppm NO intermittent inhalation treatment as measure by the     rate of adverse events.      In this prospective double-blind, randomized multi-Center study the investigators will enroll     up to 120 (no less than 80) subjects aged 0-12 months-old, diagnosed with acute bronchiolitis     and requiring in-patient hospitalization.      Enrolled subjects will be randomized into 2 groups. Group 1 -Treatment group - Will receive     160 ppm NO given intermittent via inhalation in addition to standard treatment for up to 5     days. Group 2 - will receive ongoing inhalation of the standard treatment for up to 5 days.     Between study and after completing all study inhalations the subject will continue to receive     the standard treatment. Oxygen (O2), NO, nitrogen dioxide (NO2) and fraction of inspired     oxygen (FiO2) delivered to the patient will be continuously monitored.      Treatment administration: Treatment blindness will be kept by separating between un-blinded     team members (giving the actual treatment) and blinded team members, and by hiding the NO     container and all study related equipment behind a curtain.      All subjects will return for follow-up visits on day 14(+5), 21(+5) days and will be     contacted on day 30 (+5) from day of admission to the department.   "
17735|NCT03053375|"     This study will examine the effects of a portable of pulsed electromagnetic field (PEMF)     device (MD Cure, Aerotel, USA) compared with a sham device on patient-reported outcomes of     pain and function in patients with either acute/subacute or chronic low back pain (LBP).   "
17759|NCT03053063|"     The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can     cause fibrosis regression and reduce associated complications in adults with cirrhosis due to     NASH.   "
17760|NCT03053050|"     The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can     cause fibrosis regression and reduce progression to cirrhosis and associated complications in     adults with NASH and bridging (F3) fibrosis.   "
18296|NCT03046056|"     The primary objective of this study is to evaluate the efficacy of filgotinib, when compared     to placebo, in establishing clinical remission in participants with Crohn's disease involving     the small bowel. Participants will have the option to enter a separate long-term extension     study if they meet eligibility requirements.   "
17736|NCT03053362|"     The purpose of this study is to evaluate the sensitivity of the THINC-it tool, in measuring     change in cognitive deficits in individuals with MDD after receiving vortioxetine.      Vortioxetine is used in this study as an antidepressant to improve mood, cognition and     quality of life. Cognition refers to intellectual functions such as thinking,     understanding, learning and remembering. Vortioxetine is approved by Health Canada for the     treatment of MDD. In addition, vortioxetine has been reported to have a beneficial effect on     cognitive areas such as executive function, attention/speed of processing, and memory, that     are commonly affected negatively by MDD. Vortioxetine is recognized by Health Authorities in     the EU and many other countries as having a benefit on cognitive dysfunction (loss of     intellectual functions) in patients with MDD.Cognitive dysfunction is a highly persistent,     pervasive and progressive abnormality in young adults (i.e., 18-65 years) with MDD.      It has also been shown that among adults with MDD who are gainfully employed, measures of     cognition are a greater determinant of overall workplace performance than is total depression     symptom severity. Several lines of evidence indicate that cognitive deficits that persist     between episodes of depression are critical determinants of functional recovery in the     workplace. The functional implications associated with cognitive impairment provide the     impetus for systematic evaluation, measurement and assessment of the domains of cognition     expected to be impaired in this patient population.      To date, no measurement tool has been sufficiently validated and/or determined to be     sensitive to the cognitive deficits in younger adults with MDD. Major limitations of     available comprehensive psychometric tools include relative lack of availability, cost, lack     of access to most healthcare providers, and above all else, the lengthy time to administer.     Moreover, the need for a psychometrist to interpret the results adds to the complexity and     the costliness of such an endeavor.      It is imperative that any tool recommended for clinical utility be aligned with the busy     nature of a high-volume clinical practice. The ideal gold standard tool for assessing the     presence of cognitive dysfunction in MDD in the clinical environment should include, but not     be limited to, features such as good conceptual coverage of cognitive domains affected in     MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture     effects and practice effects. The tool would also need to be brief, easy to administer and     interpret, and complement busy clinical practice.      It is anticipated that the THINC-it tool will be free of charge and downloadable from the     THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be     accessible via computers/tablets, will take 20 minutes to self-administer in a clinical     setting, and the performance results will be immediately available.   "
17737|NCT03053349|"     Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor     pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical     practice at the most active transplant centers in North America and Europe.      The aim of this observational prospective monocentric study is to prove the safety and     efficacy of EVLP performed in the setting of Bergamo lung transplant program.      A statistically estimated sample size would not fit with the small numbers of Italian lung     transplant activity, so the investigators decided to enrol 10 consecutive recipients of     grafts subjected to EVLP.      Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and     standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP.      The donor lung procurement operation will be done in the usual manner. The EVLP procedure     will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators     decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP     will proceed over a period of at least 4 and not more than 6 hours.      After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be     evaluated:        -  ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen          (PO2/FiO2, mmHg)        -  Pulmonary Vascular Resistance (PVR, dine*s/cm5)        -  Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)        -  dynamic lung Compliance (Cpldyn, ml/ cmH2O)        -  ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240          minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed.      The lung graft will be accepted for transplantation if, after 240 minutes from the start of     EVLP, the following conditions are fulfilled:        -  PO2/FiO2 >350 mmHg        -  stability or reduction of PVR compared with the measurement at the baseline assessment          time point        -  stability or reduction of PIP and Pawm compared with the measurement at the baseline          assessment time point        -  stable or better Cpldyn compared with the measurement at the baseline assessment time          point        -  ΔPO2 >400 mmHg        -  improvement of X-ray imaging compared with that at the baseline assessment time point        -  exclusion of oedema and purulent secretions by bronchoscopy. After transplantation the          recipients will be followed-up for 1 year according to a scheduled timetable.      Data about the EVLP and transplant procedure and about the characteristics of donors and     recipients will be collected in a dedicated electronic Case report form (eCRF) according to     Good Clinical Practice.   "
17738|NCT03053336|"     The aim of this study is to investigate the effect of using new app-based technology to     improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is     that the intervention, i.e. using the new technology, will have a greater positive effect on     physical activity levels and outcomes of HbA1c than usual care.   "
17739|NCT03053323|"     The purpose of the Preconception and Pregnancy Obesity Treatment and Prevention Among Women     with A History of Depression preliminary study is to provide a lifestyle intervention for     women with a history of depression who are trying to conceive or are pregnant in order to     prevent excessive pre-pregnancy weights, avoid excessive gestational weight gain, and to     improve other markers of metabolic health. The treatment program consists of 10 private     sessions with a trained clinician at no cost to participants.   "
17740|NCT03053310|"     Background Approximately half of head and neck cancer patients are 65 years or older at     diagnosis. Treatment decisions in this older HNCA population are challenging, because of the     lack of evidence-based guidelines. Surgery is often the treatment of choice in a HNCA setting     where curative treatment is intended. Though chronological age per se has not been reported     as a contraindication for surgery, data are limited and often the result of retrospective     studies. Measurement of functional age, through a comprehensive geriatric assessment, has     been suggested by several international cancer organizations to be a better prognostic     indicator. At the divisions of maxillofacial surgery and otorhinolaryngology, a geriatric     assessment is part of routine preoperative staging for patients of 70 years old or older.      Objectives The investigators aim to determine the value of G8 to predict 30-day postoperative     comorbidity in an older HNCA population undergoing elective curative surgery. Moreover, they     aim to examine the vulnerability profile of patients undergoing elective head and neck     surgery for an oncology diagnosis.      Study design All patients of 70 years and older, presenting at the divisions of maxillofacial     surgery and otorhinolaryngology for curative surgery of a solid head and neck tumour undergo     a geriatric consult as part of routine preoperative staging. The presence of postoperative     morbidity and mortality within the first 30 days after surgery will be collected as a primary     endpoint.      At 30±10 days postoperative, all patients will be re-evaluated with the G8 and the CGA.     Patient' quality of life will also be re-examined within 30 days postoperative and again at 6     and 12 months postoperative.      Conclusion There is still no consensus whether older HNCA patients should receive a different     treatment compared to younger patients. Data related to the vulnerability profile of older     patients requiring HN surgery, and the predictive value of geriatric screening for     postoperative morbidity could enable better patient selection in the future.   "
17742|NCT03053284|"     This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on     preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and     insulinoma.   "
17743|NCT03053271|"     This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101     to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous     Cushing's syndrome. Following wash-out, all eligible subjects will undergo a 6-week     open-label dose escalation with ATR-101. Subjects who continue to be eligible will then     undergo a 4-week randomized withdrawal period. It is anticipated that the overall duration of     the study per subject will range from approximately 14-20 weeks.   "
17744|NCT03053258|"     Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to     identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in     previous animal models.      Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis     System in the early detection of VOC's associated with VAP.   "
17785|NCT03052725|"     This is a multicenter, open-label (OL) extension study to obtain additional long-term safety     data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed     dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who     completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The     study consists of a screening/baseline visit followed by a 36-week OL treatment period and a     15-week follow-up period.   "
17746|NCT03053232|"     Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of     gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic     mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers.     Endoscopic procedure associated gastrointestinal perforation is one of the the most severe     complications, which is associated with high morality and needs timely detection and     effective treatment in clinical practice.Over 90% procedure associated gastrointestinal     perforation occurs immediately within 24 h after endoscopic procedure.Endoclips have been     widely used in closing the immediate gastrointestinal perforations, but the location of the     endoclips could influence the effective rate, limiting its application. In addition, multiple     endoclips should be placed under endoscopy for a relatively large perforation, which could     increase the medical cost and the procedure time. At recent, a new purse string suture device     (LeoMed, China) has been developed by us and introduced to the clinicalmanagement of such     patients with procedure associated gastrointestinal perforations. Clinical data validated     that the usage of this new purse string suture in treating immediate procedure associated     perforations was greatly convenient and effective with very low reoperation rate and     postoperative complication rate. A specially designed loop was equipped in this device, which     could be tightened under endoscopy. Thus, compared with the placement of endoclips, this     device could be more convenient and effective in completely closing the gastrointestinal     perforations.This study will test whether purse string suture device will increase the     effectiveness of closingimmediate procedure associated gastrointestinal perforationsunder     endoscopyin a randomized controlled trialby comparing the use of purse string suture     deviceand endoclips.   "
17747|NCT03053219|"     The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced     NSCLC who participant in [14C] AC0010 ADME (absorption, distribution, metabolism and     excretion) trial and subsequent receiving AC0010 treatment   "
17748|NCT03053206|"     One-third to one-half of patients with AML relapse and in general relapsed AML patients have     a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed     by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage     chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be     significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active     agents in AMLand have been used as monotherapy and in combination in refractory and relapsed     AML patients. According to previous studies the present CR rate of different regimens ranges     from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML     patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR     rates of approximately 70%. Therefore, we have planned this study to test the efficacy and     toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.   "
17749|NCT03053193|"     The FLEX Registry will be implemented to operate as a large-scale, population based,     prospective registry. All patients with stage I to III breast cancer who receive MammaPrint®     and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX     Registry, which is intended to enable additional study arms at low incremental effort and     cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and     arms can be added after the initial study is opened.   "
17750|NCT03053180|"     This prospective, multi-center, observational study is designed to assess the real world     effectiveness and safety of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting     antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) in participants with chronic     hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in     Russia.   "
17751|NCT03053167|"     Irinotecan and raltitrexed are active against advanced colorectal cancer (ACC), act through     different mechanisms, and have only partially overlapping toxicity profiles. The purpose of     this study is to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line     treatment in advanced colorectal cancer patients.   "
17752|NCT03053154|"     The purpose of this study is to assess and determine the influence of pelvic inclination on     sit to stand task in stroke patients.   "
17753|NCT03053141|"     The objective of the RHAPSODY study is to evaluate the performance of new software features     in subjects undergoing standard of care catheter-based endocardial mapping for atrial or     ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this     study will be used to guide development and refinement of new software features that may be     implemented in future commercial software releases.   "
17754|NCT03053128|"     Coronary heart disease (CHD) is a public health care challenge. There are three types of     treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery     bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those     treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients,     which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is     its advantage. Ischemia condition can be improved after CSWT. There are only three cities in     China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators     designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.   "
17755|NCT03053115|"     The aim of the study is to evaluate the peripheral tissue response to the combined     administration of levothyroxine (LT4) and liothyronine (LT3) in hypothyroid patients with     residual thyroid function virtually absent (thyroidectomized). Cases will be treated with     LT4+LT3, at personalized doses according to clinical guidelines and respecting the circadian     rhythmicity of LT3 and the physiological T3/T4 ratio. Controls will be treated with LT4 and     placebo. Treatment duration: 24 weeks.      The primary endpoint will be the peripheral effect of thyroid hormones, measuring tissue     markers levels, such as thyroid stimulating hormone(TSH), sex hormone binding globulin     (SHBG), total cholesterol, LDL cholesterol, lipoprotein A, osteocalcin, urinary     N-telopeptide, ferritin, myoglobin, creatine kinase, glucose 6 phosphate dehydrogenases,     angiotensin-converting enzyme (ACE). The secondary endpoints are bone and metabolic     modifications, evaluated by DEXA, quality of life, tissue specific miRNA expression,     polymorphisms of genes involved in thyroid hormones metabolism.   "
17756|NCT03053102|"     The purpose of this study is to determine the safety and effectiveness of ACH-0144471 in     currently untreated patients with PNH. This study is designed to include 4 to 12 patients.   "
17757|NCT03053089|"     AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the     enzyme peripherally and to the brain, when administered intravenously. This is a safety and     tolerability study to obtain safety and exposure data as well as information on the     biological activity of the investigational drug.      This is a two-stage, sequential, single and multi-dose study of AGT-181 in patients with MPS     I. The first stage will be an open-label, single-dose, dose-escalation cohort study and the     second stage will be an open-label, multi dose, adaptive dose escalation cohort study.   "
17758|NCT03053076|"     To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells     transfusion on clinical outcome in preterm infants   "
17881|NCT03051477|"     This study will seek to determine the safety and toxicity profile as well as the maximum     tolerated dose of Helixor® M in patients with advanced solid tumors.   "
17761|NCT03053037|"     This study is looking into two different ways to perform a root canal treatment. The study     will look at differences and compare the two different treatment options over a 2-year     period.More specifically, this study evaluates a small skinny root canal shape compared to     a larger broad root canal shape and if this affects the success of the root canal     treatment. Both types of treatment are standard of care and aim to treat the infection inside     your tooth. When a tooth is infected with bacteria, we can see a dark area on the radiograph     around the roots of the infected tooth. If this dark area becomes smaller or goes away     completely after root canal treatment and you do not feel any pain or other symptoms, then we     know that the treatment was successful and there is no need for further treatment on this     tooth. To measure the size of the dark area around the tooth (i.e. volume) before and after     the treatment we will need to take two limited volume three-dimensional radiographs (cone     beam computed tomography-CBCT), one prior to treatment and one at two years after the root     canal treatment is completed. These radiographs are more accurate in detecting changes in     lesion size than the regular periapical radiographs. We will assess the changes in lesion     volume for all teeth included in the study and that will help us find differences in success     between the two root canal treatment protocols, We are specifically looking for persons that     have been diagnosed with a necrotic permanent mandibular molar with an evident radiographic     lesion (i.e. dark area around the tooth) that can be retained in the mouth with root canal     treatment and permanent restoration. This study place participants in different treatment     groups after randomization. Randomization means that you are placed by chance (like flipping     a coin) into a treatment group. For this study, there are two treatment groups (protocol) and     they are listed below.      Protocol 1: Group S: Root canal treatment will be performed in 2-visits using hand files and     rotary instruments to a final canal shape of size #25.      Protocol 2: Group L: Root canal treatment will be performed in 2-visits using hand files and     rotary instruments to a final canal shape of size #35   "
17762|NCT03053024|"     The purpose of the study (retrospective and prospective) is to describe participant and     disease characteristics and treatment pattern of Bortezomib treated mantle cell lymphoma     (MCL) participants in China.   "
17763|NCT03053011|"     As part of developing a relay alarm project, the aim of the study is to test a sleeper's     capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).   "
17764|NCT03052998|"     Many studies have reported an association between epilepsy, including Nodding Syndrome (NS),     and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted     particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or     insufficiently controlled with mass Ivermectin distribution. There is evidence that     increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal     evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy     (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these     patients will have major consequences.      Objective      To assess whether Ivermectin treatment decreases the frequency of seizures and leads to     seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate     such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and     that therefore we should increase our efforts to eliminate onchocerciasis.      Methods      We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to     compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate     Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants     will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for     epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the     fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction     compared to baseline seizure frequency. Reduction of seizures will be compared between     Ivermectin and non-Ivermectin arms.      Current status      Start of enrolment is planned from March 2017 and we expect to have enrolled all 110     participants by August 2017. Results are expected early 2018.      Discussion      If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or     significantly reduces seizure frequency in OAE patients this will have major consequences for     epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in     non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will     have a major impact on quality of life and socio-economic status of families with affected     members in Africa.   "
17765|NCT03052985|"     Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women     Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse,     rectal prolapse), or incontinence surgery may be source of severe complications.   "
17766|NCT03052972|"     This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in     subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals     (BIOCARD) study at Johns Hopkins University.   "
17767|NCT03052959|"     The BETTER intervention consists of supportive meetings between a specially trained     prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic     disease prevention and screening activities (CDPS). The prevention practitioner nurse will     assist participants to identify goals for accomplishing CDPS activities in the next 6 months.     Promotion, recruitment of participants and delivery of the BETTER intervention will be     adapted to meet the needs of the residents through the use of participatory research methods     and community engagement strategies. The study population consists of individuals aged 40-64     years living in 10 designated areas or clusters within Durham Region in Oshawa and Whitby.      Objectives:        1. Help people in the designated areas identify personal goals related to chronic disease          prevention and screening activities.        2. Evaluate whether the prevention practitioner was effective in helping people achieve          their goals and explore whether this type of intervention could work in other settings.        3. Share what the investigators learn with government and other public health units in          Ontario and across Canada.      Some clusters will receive the BETTER intervention right away and other clusters will be in a     wait-list control group to receive the intervention 6 months later. Our main outcome is the     change in a score that considers the number of preventive health items a person has achieved     during the 6 months. The investigators will also be doing in-depth interviews and focus     groups with health care providers, community organizations and people who live in the     designated areas to understand whether the primary practitioner was effective.   "
17768|NCT03052946|"     Randomized trial with a estimated number of 60 patients with mild or moderate anal     incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of     the University of São Paulo (HC-FMUSP).        -  Exclusion criteria: symptoms of anal incontinence for less than six months, with severe          anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy,          evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel          disease, malignant disease Congenital formation, scleroderma, Parkinson's disease,          immunosuppression and ongoing gestation. In addition, those patients who do not agree to          participate in the survey will be excluded.        -  The study will have 4 phases: preoperative, surgical, recent postoperative and later          postoperative   "
17780|NCT03052790|"     The purpose of this study is to compare the outcomes and accuracy of implant positioning in     robotic assisted total knee arthroplasty with traditional manually instrumented total knee     arthroplasty.   "
17781|NCT03052777|"     This study evaluates the impact of a 12-week theory-based exercise telephone counselling     program (versus a self-directed exercise group) on closing the exercise intention-behavior     gap in a sample of hematologic cancer survivors.   "
17782|NCT03052764|"     This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®),     compared to placebo, when injected into the bladder using an alternative injection paradigm     in reducing the number of daily urinary incontinence episodes in patients with overactive     bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with     an anticholinergic.   "
17769|NCT03052933|"     COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment     for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol,     which would be expected to be feasible and effective in this group of patients.      Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with     sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in     relapsed/refractory, aggressive NHLs, suggesting an ORR of 50% for T-cell lymphomas.      Gemcitabine has demonstrated clinical antitumor activity against PTCLs including NK/T-cell     lymphomas both as single-agent (ORR 30-50%) and in combination therapy, with limited     extramedullary toxicities.      Considering the evidence of activity for both agents against PTCLs, the investigators propose     that targeted therapy with copanlisib in combination with gemcitabine will exhibit early     elimination of rapidly growing tumor cells and be a rational therapeutic modality for use in     relapsed or refractory PTCLs, if the overlapping toxicities can be managed.   "
17770|NCT03052920|"     This longitudinal study evaluates the possible benefit of cochlear implantation in the poor     ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better     hearing ear.   "
17771|NCT03052907|"     The investigators will expand BSPan's reach and sustainability by systematizing how to enable     counties to assume responsibility for one or two of the components while Moncrief/uTSW     continues to provide centralized financial review and reimbursement as the Texas BCCS     contractor. The investigators will prospectively identify which counties have the necessary     program capacity, then test whether implementation of BSPan tailored to a county's capacity     and local needs can lead to equivalent program success in an additional 12 rural counties.     Findings will be used to develop a model by which BSPan benefits can be brought to rural     communities across the country.      The investigators will use a readiness assessment criteria (RaC) to gauge county capacity and     readiness for BSPan program implementation. The goal of our evaluation is to demonstrate     whether a regional decentralized delivery (hub-and-spoke) model can be sustained and increase     program reach to underserved rural women. The RaC tool serves two purposes: 1) to determine     county capacity and 2) harness program data to facilitate communication during operations     between a central BSPan hub and each county partner (spokes).      Our evaluation will analyze county training and implementation of BSPan program components,     and comprehensive screening processes of the hub and spoke model. The investigators will use     county site visits and selected interviews of participants and staff to gain insight into     factors at the participant and county levels that facilitate adoption and implementation of     comprehensive screening processes, in conjunction with key quantitative metrics and process     outcomes.      The investigators will apply the Glasgow Re-aiM model to guide our evaluation of BSPan     program component implementation in each county. Re-aiM specifies dimensions at the     participant and organizational levels. Dimensions are defined as the intervention's: 1) Reach     into the target population, 2) effectiveness in modifying risk, 3) adoption by target     settings, 4) consistent implementation, and 5) Maintenance of its effects among participants     and target settings. our mixed-methods approach will enable focus at both the individual and     organizational levels and has been successfully used to assess other similar screening and     health promotion programs.   "
17772|NCT03052894|"     The objective of this study is to determine the accuracy of a hydraulically coupled twitch     monitor compared to the EMG twitch monitor in current use to measure the extent of     neuromuscular blockade in patients undergoing general anesthesia.   "
17773|NCT03052881|"     The purpose of the study is to determine whether use of a robotic system improves the     precision and therefore safety of high precision steps in retinal surgery. Two common     surgical scenarios (ERM/ILM peel and sub retinal haemorrhage displacement surgery) that     require a high degree of precision to avoid damage to the retina have been chosen for this     trial. These steps also have been selected because they allow a clearly definable outcome     measure e.g. time taken to complete a specific step in the operation. The main issue here is     that the patients will be undergoing this procedure regardless of enrolment in the trial -     the only difference being that for study participants the surgeon will perform parts of the     operation with the assistance of the robot.   "
17774|NCT03052868|"     Data for this study will be obtained from the University of Texas Southwestern Medical Center     Simmons Comprehensive Cancer Center. Participants will be recruited through Simmons Cancer     Center. One hundred female breast cancer patients who have completed adjuvant chemotherapy     will be enrolled. In order to reach this number, it is estimated that up to 125 eligible     participants will need to be recruited. The study will last approximately two years.     Participants will undergo one cognitive testing session, and each subject's total     participation time will last no more than two hours.   "
17775|NCT03052855|"     Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000     suicide attempts every year. SB management is therefore a major public health issue.      Evidence associated dysregulation of the serotonergic system and the     hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these     abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity.     There is a need to better understand the physiopathology and develop diagnostic and     therapeutic tools in SB.      The investigators hypothesize that increased peripheral biomarkers of inflammation would     correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially     in suicidal patients.      Our aim is to compare rates of cerebral metabolites, in particular the complex     glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior     cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with     and without suicidal attempt.   "
17776|NCT03052842|"     Single-blind study to evaluate whether C16G2 Strip administered in multiple doses can     effectively kill the bacteria in the oral cavity that cause dental caries..   "
17777|NCT03052829|"     The benefits of regular physical activity are well-established. Furthermore, the     investigators have previously shown that in a population of patients with implanted     pacemakers, those who exercise more than 2 hours daily have improved survival compared with     those who exercise less than 2 hours daily. In this study, the aim f the investigators is to     determine whether the offering subjects with pacemakers who have low levels of physical     activity at baseline counseling to increase physical activity levels is effective as measured     by their implanted device as well as by an external pacemaker.      The investigators seek to enroll about 30 patients into a 6-month 1:1 randomized     interventional trial comparing the levels of physical activity in 2 groups, those who receive     physical activity counseling versus usual care. The activity levels will be measured with     external pedometers and with accelerometers embedded within the pacemaker device.   "
17778|NCT03052816|"     The purpose of this randomized controlled trial is to determine whether, ICE-T, a novel     multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and     tylenol, has improved pain control intake compared to the standard postoperative pain regimen     in patients undergoing vaginal pelvic floor reconstructive surgery.   "
17779|NCT03052803|"     The aim of the study is to compare different devices available to measure fractional flow     reserve (FFR) in coronary arteries.   "
17786|NCT03052712|"     The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's     disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic     brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to     a large group of emotional and cognitive abilities regulating inter-individuals relationships     and it includes mainly theory of mind, emotional information processing and empathy. However,     assessment of socio-emotional processes is still largely based on experimental tests that are     not validated for clinical purpose. In addition their long duration of administration is not     adapted to clinical examination. Finally these tests have not been standardized and     normalized in French-speaking population.   "
17787|NCT03052699|"     This database has for objective to include the medical data of patients which underwent a     vaginal Cesarean Section in our establishment. This collection will allow to determine the     risk factors of the maternal morbi-mortality and to estimate the long-term results   "
17788|NCT03052686|"     This study has for objective to collect medical data from patients with uterine rupture at     the childbirth.   "
17789|NCT03052673|"     The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve     gastrectomy are collectively covered under the term `bariatric surgery`. The growth of     bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure     patient safety and facilitate post-surgery outcome. Conventionally, balanced general     anaesthesia techniques routinely use opioids peri-operatively for intra-operative     haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese     patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the     same technique when employed in the morbidly obese patients hampers early and intermediate     postoperative recovery due to the occurrence of side effects, such as, sedation, PONV,     respiratory depression, depressed GI-mobility. The above stated side effects, have lead to     increased propensity for postoperative cardiac and pulmonary complications. Obese patients     are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be     employed judiciously in these patients. On the other hand, the reduction in opioid use may     result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we     need to minimise opioid use and employ some other drugs which besides having analgesia, has a     opioid-sparing effect also.      Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in     sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic,     anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a key     advantage of ketamine is that it can reduces post-operative pain and use of opioid when used     per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely to     decrease opioid-related postoperative morbidity in these patients undergoing bariatric     surgery.In view of the above, a clinical research is highly desirable to study techniques to     decrease the use of opioids in obese surgical patients.This prospective randomised two-arm     study aims to assess the effect of low-dose ketamine on postoperative pain relief and     opioid-sparing ability in obese patients undergoing bariatric surgery.   "
17790|NCT03052660|"     We aim to assess, if placebo compared to preoperative administration of midazolam in elderly     patients is equal in regard to the global postoperative patient satisfaction   "
17791|NCT03052647|"     The objective of this study was to compare the an adhesive latch device ( Dermaclip) to     subcuticular skin closure at the time of cesarean section. Currently, no studies exist     comparing these two closure techniques. The hypothesis is dermaclip closure is faster than     subcuticular closure. The null hypothesis is there is no difference in closure times. There     is a study (see reference at bottom) that compares staples closure to subcuticular closure,     but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and     is expected to be as fast as staples closure compared to subcuticular as noted in the prior     study referenced below.   "
17792|NCT03052634|"     A significance,safety and pharmacokinetic of open-label and multicentric Phase Ib/II Study of     RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Breast Cancer   "
17793|NCT03052621|"     Locally advance breast cancer and extensive locoregional recurrence are still considered as     complexity of reconstruction. Although previous studies concluded that omental transposition     was considerably indicated in poor vascularity in irradiated tissue, secondary infection and     large defect become the obstacles of local tissue flaps. While some centres showed the     excellent healing of omental transposition. Meanwhile, many studies showed the preferable     outcome in escalating radiotherapy in term of locoregional control. In the investigators'     institute, omental transposition in breast cancer has been developed for twenty years. The     only institute in Thailand enhanced using this procedure in order to closure of large primary     breast cancer and chest wall recurrence. This procedure is undertaken by single surgeon (Dr.     K.J.). The investigators' protocol of omental transposition is including preoperative     chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of breast cancer     centre committee, and meticulous wound care including vacuum assisted wound dressing,     non-adhesive dressing. As a result, survival time could be improved.   "
17794|NCT03052608|"     A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to     crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC     patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to     overall survival in the same population   "
17795|NCT03052595|"     Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central     nervous system (CNS) and is one of the most common neurological diseases, often leading to     disability of the patients. The MS pathogenesis includes vascular and inflammatory     components, however recently also the role of mitochondrial dysfunction being a hot topic in     neurodegeneration.   "
17796|NCT03052582|"     The aim of the project is to investigate the effects in humans of a daily intake of whole     milk compared to skimmed milk primarily and secondarily respectively on:        -  Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides        -  Risk markers of diabetes type 2: plasma glucose and insulin   "
17797|NCT03052569|"     Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations     who have not received TKIs that target RET alterations, who do not qualify for participation     in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.   "
17960|NCT03050437|"     It has not been established whether platinum-based doublets is better than single agent     chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI.      In this prospective trial, the investigators try to evaluate whether the progression-free     survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P)     regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.   "
17882|NCT03051464|"     A randomized study of 234 patients. Patients with a clinical T2-3 N0 rectal cancer will be     randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or     Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard     chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a     brachytherapy boost of 30 Gy in 3 fractions).   "
17798|NCT03052556|"     Background The main risk factor for cervical cancer is the infection by human papillomavirus     (HPV), with several intermediate steps between HPV infection and cervical cancer. Cervical     screening with pap smear test and HPV vaccination are effective preventions. A high frequency     of HPV carriage and of cervical dysplasia have been described in transplanted women.      The majority of women with cystic fibrosis reach adulthood and some will face     transplantation. Particular attention should therefore be paid to cervical screening.     However, low adherence to screening recommendations was noted. In addition, preliminary data     has found a high frequency of abnormal smears and of inflammatory aspect of the cervix in     women with cystic fibrosis.      Objectives of the study The main objective of the study is to determine the prevalence of HPV     carriage in a cohort of women with cystic fibrosis      The secondary objectives are:        -  To study the factors associated with the prevalence of HPV (transplantation, smoking,          age at first intercourse, number of sexual partners in the year, contraception,          gravidity and parity, HPV vaccination)        -  To describe and to compare with data in the general population, in hospital-based          population, (and with data in transplanted population for transplanted women)             1. the prevalence of HPV (and of different genotypes) infection, of cervical               dysplasia, of vulvar/vaginal/cervical condylomatosis             2. the rate of HPV persistence (> 12 months), the mean time of HPV clearance; rates of               spontaneous regression / persistence / worsening of cervical dysplasia      Study design:      The study will last 24 months. Includable patients are adult women, transplanted or not,     followed at Lyon CRCM. Included women will attend a consultation with a gynaecologist. Pap     smear test (liquid phase cytology) and genomic DNA microarray assay enabling the detection of     35 different HPV genotypes will be performed.      Patients with an initial abnormal pap smear or a positive HPV test will be monitored:        -  In case of an abnormal smear and / or positive HPV test, pap smear and HPV testing will          be renewed every 6 months during the study period        -  In case of an abnormal smear:      Atypical squamous cells of undetermined significance (ASC-US) : the attitude will depend on     the result of the HPV test Atypical squamous cells - cannot exclude HSI L (ASC-H), Low-grade     squamous intraepithelial lesion (LSIL), High-grade squamous intraepithelial lesion (HSIL),     Atypical glandular cell of undetermined significance (AGUS) , Atypical glandular cells (AGC)     , Adenoma carcinoma in situ (AIS), carcinoma: a colposcopy will be systematically performed      Expected results This study will help to determine the frequency of HPV infection and the     pathogenic power of HPV in non-transplanted and in transplanted women with cystic fibrosis     This data will help to sensitize health professionals on the importance of gynecological care     and regular cervical screening, and on the importance of HPV vaccination.      In case of a high frequency of genital diseases linked to HPV, recommendations on     gynecological monitoring procedures for women with cystic fibrosis could evolve.   "
17799|NCT03052543|"     This pilot study is being conducted to determine whether the intraoperative presence of a     Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and     postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to     the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in     adult and pediatric studies it has been shown to decrease time to emergence, decrease     volatile anesthesia requirement, decrease recovery time and in some cases, decrease     post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters,     when BIS is present but not specifically designated to be used as a monitor to guide     anesthesia delivery, has not been specifically examined. This will be the first pediatric     study which applies BIS on all patients and randomizes the anesthesiologists to either be or     not be privy to seeing the BIS values during intra-operative period.   "
17800|NCT03052530|"     A prospective, open label, multi-center, single arm, observational study designed to evaluate     the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA     dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during     percutaneous coronary intervention.      Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters     1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts     during their index procedure. All subjects will be screened according to the protocol     inclusion and exclusion criteria and will be followed through hospital discharge.   "
17801|NCT03052517|"     This study is a 2-treatment period, randomized, multicenter parallel-group study. The overall     purpose of this study is to provide long- term safety data for fevipiprant (QAW039) (Dose 1     and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA)     steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with     moderate-to- severe asthma.   "
17802|NCT03052504|"     The study will examine which differences there are in comorbidity and complications collected     retrospectively from medical records compared with data collected prospectively in two groups     of patients undergoing either radical cystectomy or radical nephrectomy.      Hypothesis is that he prevalence of registered comorbidity and minor complications in     patients who have undergone radical cystectomy or nephrectomy, will increase if the data     collection is focused and prospective, compared with retrospectively collected data.      The study will be conducted as a single-blind randomized controlled trial. Patients included     in the study will be randomized to either control or intervention in the ratio 1:1. There are     two groups of patients: Patients admitted to radical cystectomy and patients admitted to     radical nephrectomy, due to cancer.   "
17803|NCT03052491|"     This open-label field trial evaluates the effects of treatment with a multi-pathway dietary     supplement (Stem Cell 100+) that has been commercially available for several years. The     objective of the intervention trial is to determine if normal subjects over 35 years of age     experience any observable health benefits from the dietary supplement as to their blood     pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported     changes in markers of overall health and life expectancy.   "
17804|NCT03052478|"     There is no accepted standard therapy for patients with advanced gastric cancer who have     progressed during or after second-line therapy. The role of 3rd line treatment in advanced     gastric cancer has not been proven.      As a novel target of gastric cancer, SMO overexpression is chosen in this study, and the     investigators plan this study to evaluate the efficacy and safety of vismodegib in gastric     cancer. The doses of vismodegib are based on trials of basal cell carcinoma.   "
17805|NCT03052465|"     Crohn's disease (CD) is becoming more common. One of the main features of this disease is     weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems     have a strong negative effect on the patients' quality of life but the causes of these     problems are not well understood. Enteroendocrine cells are nutrient sensors in the bowel     that secrete special chemicals (called hormones) that control appetite and the movements all     the gut. The investigators think that this control mechanism goes wrong in Crohn's patients     and they have set off to do more research on this. Looking at the inside work of the gut has     always been difficult and at times unpleasant for patients, however recent developments in     magnetic resonance imaging (MRI) are allowing the investigators to study the workings of the     gut in greater detail and without discomfort for the patients.      Our main objective is to investigate the difference in small bowel motility between CD     patients with active ileal disease and healthy volunteers.   "
17826|NCT03052192|"     In this study, the investigators will investigate and characterize acute medical patients in     order to optimize patient courses in the acute care departments, especially with regard to     polypharmacy and undernourishment. In addition, the investigators will investigate underlying     immunological mechanisms of chronic inflammation and biological aging in this population to     improve the current knowledge and possibilities for preventing chronic diseases and acute     hospitalization.   "
17806|NCT03052452|"     The proposed My Nutritional Health (MNH) app is a unique tool for consumers interested in     tracking their food intake and linking diet to symptoms.      The investigators will test this app for developmental purposes among a sample of 100     participants who are patients of dieticians at Cedars-Sinai Medical Center (CSMC) and the     University of Michigan (UM) with varying presentation of GI symptoms and suspected food     intolerances. The MNH app will be used as a data collection platform for this study and can     be utilized by any device supporting iOS (tablets, ipads, iphones, and Android. The     investigators will use the data collected in the app testing to develop population level FAST     scores.      The MNH app includes two integrated functions:        1. Patient Symptom and Food Consumption Reporting        2. FAST Score calculation It is important to note that, per this protocol, the MNH app will          only be evaluated for developmental purposes. It is currently not meant to serve as a          diagnostic tool, nor to provide referrals for patients with food and symptom patterns          that may suggest a food intolerance. In this respect, our test app is not governed by          FDA or other regulatory bodies, as it does not make diagnoses or offer specific          guidance. The purpose of this study is only to develop normative scoring distributions          of FAST within the context of patients visiting GI dieticians as part of routine care.   "
17807|NCT03052439|"     Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of     the US population and up to 20% of the population worldwide. This is a condition that is     diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as     the exclusion of select other GI diseases. IBS not only causes constipation, diarrhea,     abdominal cramping, and bloating, it also significantly affects quality of life, overall     functioning, and work productivity.      The cause of IBS is likely multifactorial, which makes it a difficult disease to treat.     However, patients often associate their IBS symptoms with eating a meal. Up to 90% of IBS     patients restrict their diet to prevent or improve their symptoms, and patients are     increasingly interested in more holistic approaches to disease management. At present, the     most persuasive evidence that dietary changes can treat IBS supports a diet low in     fermentable carbohydrates (the low FODMAP (fermentable oligo, di, and monosaccharides and     polyols) diet). This diet, which is low in certain carbohydrates, has been shown to improve     IBS symptoms (particularly abdominal pain and bloating), but can be difficult to follow and     quite restrictive. In addition, this diet is not meant to be used as a maintenance diet;     patients undergo an elimination phase followed by a reintroduction phase of specific     carbohydrate groups as they monitor their symptoms. From the results of our proposed study,     the study team hopes to arrive at a modified, less -restrictive version of the low FODMAP     diet that is equally effective, and also create a standard protocol that patients can use     during this reintroduction phase.      Patients with IBS will be recruited into a 13-week trial that would help determine the     optimal way in which high FODMAP foods should be introduced. After consent, patients would     start on a low FODMAP diet for 14 days, and if their symptoms improve, they would be invited     to continue in the study. For 7 days prior to the reintroduction of individual FODMAPs,     patients will ingest 1daily servings of a low FODMAP nutrition drink to validate the low     FODMAP content of this dietary supplement. If patients do not experience a flare of symptoms     with the supplement, they enter the reintroduction period. During this period, subjects would     introduce different groups of FODMAPs in a blinded fashion while remaining on an otherwise     low FODMAP diet while monitoring their IBS symptoms. At the end of the study period, subjects     would be informed of the FODMAPs to which they were sensitive and would meet with a     dietitian. At the completion of the study, the investigators would compile the data and     determine which FODMAPs were mostly likely to exacerbate IBS symptoms, thus providing the     construct for a modified low FODMAP diet, or low FODMAP-Light. It is hoped that this     modified, less restrictive version of the low FODMAP diet would be equally effective for the     majority of IBS patients.   "
17808|NCT03052426|"     The aim of this study is to combat the growing global health issue of sedentary behavior and     the associated health consequences of prolonged sitting in the workplace. The population of     desk-based workers makes up a relatively large population and are an important target for     this health promoting initiative with a focus on improving posture, encouraging movement, and     fostering a more active and healthy business community. It's important to recognize that     occupational therapy practitioners can contribute to community health promotion/disease     prevention programs by the skill-set of practitioners to understand habits and routines that     influence the adoption and maintenance of healthy behaviors.   "
17809|NCT03052413|"     The objective of this study is to assess the safety and effectiveness of a nutraceutical     supplement for the treatment of hair loss and thinning in females over the course of six     months of continuous daily use.   "
17810|NCT03052400|"     Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety     of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated     with Cushing's syndrome, and sub-optimally controlled on oral anti-hyperglycemic agents   "
17811|NCT03052387|"     Using autogenous Chin block for vertical augmentation with simultaneous implant placement at     anterior maxilla region comparing between the Onlay and Inlay grafting techniques.   "
17812|NCT03052374|"     Postpartum depression (PPD) is a major public health issue. Known as the thief that steals     motherhood since symptoms obstruct a mother's capacity for understanding and enjoying her     baby, PPD affects approximately 1 in 5 moms. Built via serve and return interactions (e.g.     baby smiles, mom smiles back), sensitive and responsive exchanges are the foundation for     healthy child development but are diminished by PPD, resulting in interactions that place     children at risk for behavioural and cognitive problems. Infants perceive PPD as stressful;     stressors stimulate the brain's hypothalamic pituitary adrenal axis (HPA) and trigger stress     hormone (cortisol) release, which, in turn, negatively affects developing infant brains by     decreasing brain volume. Infants' critical periods of brain development are vulnerable to     long-term effects of cortisol, explaining some of the problematic developmental outcomes     observed in children of depressed mothers.      How can the investigators support depressed mothers and their infants? Successfully treating     PPD does not always benefit mother-child relationships; however, this research builds on a     successful pilot that demonstrated that nurse-guided video feedback improved mother-infant     interactions in the context of PPD. By improving interaction quality, depressed mothers may     be motivated to engage in more play and, in turn, infants who appear interested and ready to     interact are more likely to elicit positive, enjoyable experiences from mothers. Building on     the pilot, the investigators will trial the effectiveness of VID-KIDS (Video-Feedback     Interaction Guidance for Improving Interactions Between Depressed Mothers and their Infants)     on maternal-infant interaction and infant cortisol patterns as well as infant development,     maternal symptoms of depression and anxiety, and parenting self-efficacy. If successful,     future aims are to 1) integrate VID-KIDS into existing services of Calgary Public Health; and     2) commercialize VID-KIDS for dissemination.   "
17813|NCT03052361|"     The investigators aim to assess whether ondansetron given at triage can reduce the number of     patients requiring emergency department observation in children with acute gastroenteritis.     The investigators will also assess the improvement of patient comfort and total length of     stay   "
17841|NCT03051997|"     The purpose of this study is to test a prize-based contingency management intervention for     increasing caregiver engagement in juvenile drug court and adolescent drug treatment, and for     achieving the ultimate outcomes of reduced substance use and delinquent behavior among drug     court-involved youth.   "
17961|NCT03050424|"     This phase II single centre, double blind, placebo-controlled, randomised trial aims to test     the hypothesis that intravenous iron improves exercise performance in Chronic Obstructive     Pulmonary Disease (COPD) as measured by constant rate cycle ergometry.   "
17814|NCT03052348|"     Staphylococcus Aureus is a common pathogen colonising the skin of Atopic Dermatitis patients     and is responsible for the frequent relapses and complications associated with the disease.     Synalar cream; Supiroban 2% and Cetamacrogol, are frequently used separately in the treatment     of AD. However the use of Supiroban 2%, in a mixture of Synalar cream and Cetamacrogol cream     as a combined formulation, has not been studied in children suffering from severe AD. The aim     of this trial is to determine the efficacy of combination therapy which includes a topical     antibiotic, a topical steroid cream and a moisturizing cream over a 3 to 4 month period in     children.      Trial Design: A two-center, single blinded, randomized parallel group, superiority trial.      Type of control: Active controls without placebo      Study population and Setting:      A sample of 44 subjects will be recruited from Red Cross Children's Hospital and Umtata     Hospital.      Estimated duration of trial: 6 months.      Duration of participation: Each subject will participate in the trial for a maximum of 90     days.      Primary endpoint: reduction in SCORAD scores; frequency of clinical flares for AD and     improvement in the quality of life at 90 days.      Benefit/Significance      A simple and effective approach to the management of atopic eczema.   "
17815|NCT03052335|"     Main objective is to improve colorectal cancer (CRC) screening programme in the Czech     Republic and decrease the disease incidence and mortality. The secondary aim is to verify the     effectiveness of incorporation of the new minimally invasive device in the prevention     programme.   "
17816|NCT03052322|"     The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022     and Humira® in adult subjects with rheumatoid arthritis.   "
17817|NCT03052309|"     The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and     clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical     practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal     arteries   "
17818|NCT03052296|"     The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and     clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long     atherosclerotic femoropoliteal artery lesions in daily clinical practice   "
17819|NCT03052283|"     Development, validation and evaluation of a new multimodal questionnaire to assess and     quantify the abdominal involvement in patients with the inherited life shortening multi-organ     disease Cystic fibrosis.   "
17820|NCT03052270|"     1. This will be a randomized prospective and open-label study with no placebo control or          blinding of the participants and the research team members. The study is to compare the          effectiveness of vaginal progesterone versus combination of vaginal progesterone and          Arabin cervical pessary in the prevention of preterm delivery among patients with          incidental shortened cervical length.        2. As part of standard clinical care, all pregnant patients usually have cervical length          measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the          GE ultrasound Volusion 8 using the vaginal probe.             1. Patients with short cervix will be counseled and offered the opportunity to               participate in the study.             2. All participants will be taught how to use the vaginal progesterone once daily               prior to bedtime. In addition, those in the combination group will have the               cervical pessary placed in the clinic right away or within a week if they request               for more time to brood over their diagnosis and weigh on the option of inserting               Arabin pessary.             3. All participants will be followed up in the high-risk obstetric clinic as per               standard prenatal care. Frequency of follow up visits will be individualized               depending on patient's need and comorbidities. , Participants will be requested to               bring the remnant of the vaginal progesterone to the clinic to assess compliance.             4. Participants in the study will continue their prenatal care with UIC high-risk               obstetric clinic until delivery.             5. The study recruitment will occur for a period of 2 years starting from November               2016 to October 2018 or until all the anticipated numbers of study subjects have               been attained.             6. There will be 10 % over-sampling to cater for those who will drop out from the               study or loss to follow up after randomization, and those who delivered in another               hospital.             7. Participants will have access to one of the investigators or the high- risk clinic               nurse for any complaints related to their conditions.             8. Participants can opt out at any stage of the study if they do not want to continue               further or if there are any adverse effects.   "
17821|NCT03052257|"     The proposed study is a randomized controlled trial enrolling Veterans with medically treated     glaucoma who report less than 100% adherence to the prescribed glaucoma therapy. Participants     will be randomized to receive either a one-on-one session with a member of the research team     discussing the disease process and strategies for administering eye drops (intervention) or a     one-on-one session with a member of the research team discussing general eye health     (control). All participants will be provided with a smart bottle to house their glaucoma     medications. The smart bottle records the date and time that the bottle is opened. For     participants in the intervention arm only, a reminder function will be activated. The     proportion or prescribed doses taken according to the monitor will be compared for the two     groups.   "
17822|NCT03052244|"     Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be     applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS     treatment will be coupled with a video of a man walking (creating a visual illusion) in order     to enhance functional ability and reduce pain   "
17823|NCT03052231|"     Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains     discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic     saline. Programs to enhance adherence, including comprehensive behavioral interventions with     adolescents, have met with mixed success. Advances in therapy, treatment delivery systems,     and data capture technology offer the potential for enhancing adherence by providing     immediate and more frequent feedback to the patient regarding his or her fidelity to the     prescribed treatment regimen. The investigators propose to evaluate a systematic yet     technically simple approach to linking treatment and feedback components to enhance adherence     in a real-work CF clinic setting that treats a significant minority patient population.      This is the first trial assessing the impact of a collaborative active intervention program     of a multi disciplinary team in improving adherence to specific chronic medications and     improving clinical outcomes in CF patients. The PI has implemented the texting service     (Caremessage.org) with COPD and diabetes patients. The content will be modified to provide     both English and Spanish language content relevant to these participants and their standard     treatment protocols.   "
17824|NCT03052218|"     Pupillometry will be performed before administration of tramadol, at T0 and then 1 to twice     per hour in children having received tramadol as a pain killer as part of his/her routine     care.      Pupillometry measurement will be correlate to CYP2D6 phenotype and CYP2D6 genetic score   "
17825|NCT03052205|"     This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate     promising clinical or biological activity.   "
17876|NCT03051542|"     The purpose of this study is to evaluate whether a semi-quantitative interpretation using the     liver SUVmax as reference can better interpret 18F- FDG PET/CT and predict disease     progression during chemotherapy or survival in NK/T-cell lymphoma.   "
17827|NCT03052179|"     Oral Lichen Planus (OLP) is an inflammatory disease of mucosal and skin with unknown     etiology. The prevalence rate in England is reported to be between 1-2.4%. OLP contributed to     around 40% of all visits or 1,200 appointments in 2014 at the Eastman Dental Hospital. Pain,     discomfort, long-standing use of medications, lesion recurrence and adverse side effects of     therapy are commonly associated with OLP, eventually leading to a significant reduction in a     patient quality of life. In addition, there is also increased risk of developing oral cancer     in patients with OLP. The current gold standard treatment for OLP is corticosteroid, which     can result in adverse side effects including increased risk of infections and skin cancer,     reduced systemic immune system, and hepatotoxicity with long-term usage.      Alternatively, a probiotic food supplement, VSL#3, has shown evidence of been able to induce     and maintain remission in Intestinal Bowel Disease (IBD), with no adverse effect a part than     bloating, reported. Additionally, a preliminary report shown that probiotics treatment in     Behcet's disease and Recurrent Aphthous Stomatitis (RAS) lesion resulted in reducing the     number of oral ulcerations and subjective relief of oral discomfort.      Investigator designed a clinical trial with 30 participants allocated to one of two     interventions, VSL#3 or placebo. Individuals with biopsy-confirmed OLP who experience painful     symptoms will be recruited from a single site research site (Eastman Dental Hospital (EDH)).     Either the active VSL#3 or the placebo, provided by Ferring Pharmaceuticals Limited, will be     consume twice a day over a 30 days period. Questionnaires that will determine pain levels,     disease activity and quality of life will be completed before the study begins, on days 15,     30 and 30 days after the last supplement intake. In addition saliva and blood samples will be     taken before therapy begin, at 30 days of therapy, and 30 days after the last supplement     intake. The levels of pro-inflammatory cytokines and the oral microbiota will be investigated     using these samples. A blinded clinician will assess the clinical effects between groups of     active VSL #3 and placebo and the results will analyze by statistician.   "
17828|NCT03052166|"     Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed     ultrasound plane waves through the breast, as well as collects reflected ultrasound output.     As the patient lays prone on a table, the breast is submerged in a warm water bath. The     transmitter and receiver assembly moves around the suspended breast to record data for     successive sub-volumes of targeted tissue. More than 2000 elements in the curvilinear     transducer's array encircle the breast to gather data from the tissue structures of the     breast, from nipple to chest wall. Information gathered from this automated QT scan     encompasses the entire breast which is currently not commercially available using any other     ultrasound technology.   "
17829|NCT03052153|"     This study will evaluate if an association exists between levels of blood flow through the     pulmonary veins and the incidence of graft dysfunction post operatively.   "
17830|NCT03052140|"     Single-blind, randomised, single centre, 2-way crossover study to collect post-market     clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.   "
17831|NCT03052127|"     The primary objective is to assess the safety, immunogenicity and preliminary efficacy of a     single treatment of one of two dose levels of Light-activated AU-011 for the treatment of     subjects with primary choroidal melanoma.   "
17832|NCT03052114|"     The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can     produce reproducible and accurate images in people with stroke or head injury compared to     existing standards such as MRI, CT.      Electrical Impedance Tomography is a relatively new medical imaging method, which has the     potential to provide novel images of brain function. It is fast, portable, safe and     inexpensive, but currently has a relatively poor spatial resolution. It produces images of     the internal electrical impedance of a subject with stroke or head injury using rings of ECG     like electrodes on the skin. EIT recording will take place as early as possible, usually     within 24 hours of admission. Following completion of the recording, the EIT images will     subsequently be analysed and compared to other imaging data for accuracy.   "
17833|NCT03052101|"     The aim of this study is to conduct survey-based assessments for the safety of air travel in     patients with pulmonary Langerhans cell histiocytosis (PLCH). The study will enroll patients     through the clinic network at Rare Lung Disease Consortium (RLDC) and through the     Histiocytosis Association website. Patients will have access to the questionnaire via REDCap     (an online data management system) and each patient will be provided with a link to complete     the survey. The investigators plan on enrolling approximately 200 patients with PLCH for the     purpose of this study. Secondary aims of this study include further characterization of the     clinical aspects of disease and to establish a contact registry for these patients, in order     to facilitate future studies.   "
17834|NCT03052088|"     This is a prospective clinical validation study of a novel regulatory approved (CE-IVD)     diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims     to externally validate the tool's diagnostic accuracy and estimate the potential improvement     in health and economic outcomes following the usage of ImmunoXpert™. Additionally,     statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice     lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled     patients will be managed according to the current standard of care and per standard     institutional procedures.   "
17835|NCT03052075|"     The primary objective of this study is to estimate the percent change in baseline bone     mineral density (BMD) starting at one year after parathyroidectomy and all the following     available dates in patients presenting with primary hyperparathyroidism. The secondary     objective is to identify patient factors associated with change in BMD.   "
17836|NCT03052062|"     The objectives of this clinical study are to determine the tolerance of dietary supplement     Lipidrive through the evaluation of several parameters :        -  Various blood biological parameters        -  Urinary parameters        -  Hemodynamic indicators        -  Cardiac function        -  Anthropometric variables   "
17837|NCT03052049|"     This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate     artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to     benign prostatic hyperplasia (BPH).   "
17838|NCT03052036|"     SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting     with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to     compare time to cardiovascular death or non-fatal MI within one year from randomization.   "
17839|NCT03052023|"     This study designed to compare the new laparoscopic dual approach to inguinal hernia repair     with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)   "
17840|NCT03052010|"     An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention     methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure     prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will     be introduced into 24 public HIV-1 care centers in central and western Kenya according to     national guidelines using a stepped wedge design, stratified by region.   "
17842|NCT03051984|"     Total knee replacement, or arthroplasty, is the final clinical intervention available to     relieve pain and functional limitations related to advanced stage knee osteoarthritis.     Despite its beneficial effects, the early post-surgical period is characterized by the     erosion of lower extremity muscle size and strength that cause further disability and slow     functional recovery. While the detrimental effects of this period on muscle are widely     recognized, the mechanisms underlying these adaptations are poorly understood and there are     currently no widely-accepted clinical interventions to counter them   "
17843|NCT03051971|"     Delivery of inhaled short-acting bronchodilators (SABD) is standard of care in the emergency     department (ED) for exacerbation of COPD, the goal of such being rapid reversal of airflow     obstruction. However, current guidelines for the delivery of SABDs in spontaneously breathing     patients make no distinction whether these medications should be delivered via metered dose     inhaler (MDI) or jet nebulizer (JN), the specific medication delivery device having no     significant effect on hospital admission or reversal of flow obstruction. However,     advancements in nebulizer design, namely FDA-approved vibrating mesh technology, have     demonstrated significant improvements relative to JNs and metered dose inhalers in efficiency     and amount of drug delivered in in vivo and in vitro studies. Currently there are no clinical     trials comparing the use of vibrating mesh nebulizers (VMN) to JNs and their effect on     clinically important outcomes. This prospective randomized controlled pilot trial seeks to     determine if there are differences in hospital admission due to COPD when a vibrating mesh     nebulizer is used versus a jet nebulizer.   "
17844|NCT03051958|"     Atopic dermatitis (AD) is highly prevalent and leads to suffering for the individual,     increased risk of depressive symptoms and anxiety, and high societal costs. A few     psychological treatment have been tested for AD, but to our knowledge none of them have been     built on recently developed methods for optimizing exposure treatment. In addition, access to     psychological treatment is limited and there is a need for new methods that could be easily     disseminated. One possible solution to this problem is to deliver psychological treatment via     the Internet, which has been tested in more than 100 randomized trials with good results for     other clinical disorders than AD. The aim of this study was to test the effects of     Internet-delivered mindfulness and exposure treatment (I-MET) for AD in a randomized     controlled trial. We hypothesized that I-MET would lead to larger reductions of AD symptoms     as well as psychological symptoms compared to treatment as usual.   "
17845|NCT03051945|"     Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.   "
17846|NCT03051932|"     This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100     patients, 50 per treatment arm, undergoing minimally invasive thoracic surgery will be     randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL)     plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA.   "
17847|NCT03051919|"     Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with     acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement     methods are used.   "
17848|NCT03051906|"     In over 60% of cases, squamous cell carcinoma of the head and neck (SCCHN) is discovered at a     loco-regionally advanced stage that requires a combined multimodal strategy in order to     pursue a curative intent. Bonner et al demonstrated that the combination of radiation (RT)     with Cetuximab (CTX), a chimeric mouse IgG1 monoclonal anti-EGFR antibody, results in better     median locoregional control and overall survival compared with RT alone without an increased     rate of > G3 acute toxicity or detrimental effect on compliance and quality of life. However,     subsequent negative trials (RTOG 0522) led to the hypothesis that in unselected patient     populations the benefit of CTX may be diluted due to the molecular heterogeneity of SSCHN.     Moreover, the absence of biomarkers predictive of response to anti-EGFR treatment may in part     be explained by the observation that other factors play a role in favoring its anticancer     effect, namely immunologic mechanisms. It has been demonstrated that SCCHN is an     immunosuppressive disease characterized by prominent immuno-escape mechanisms, such as     induction of a tumor-permissive cytokine profile and qualitative/quantitative lymphocyte     deficiencies, occurrence of anergy in major immune effector cells and poor antigen     presentation. Given these observations, it has been postulated that SCCHN may benefit from     immunotherapeutic strategies, primarily aimed at PD-L1/PD1 checkpoint blockade. Segal et al     (Asco 2015) reported preliminary results on the use of Durvalumab in pretreated patients with     recurrent/metastatic SCCHN. Durvalumab is a humanized monoclonal IgG1 antibody that blocks     PD-L1 binding to PD-1 and CD80 with high affinity and selectivity, thereby promoting activity     of tumor-specific effector T cells and global anti-tumor immune response. Out of 64 treated     patients, 51 patients were available for the preliminary efficacy analysis: promisingly, the     overall response rate was 12% (25% in PD-L1 positive patients). To date, no clinical trial,     specifically designed for SCCHN, testing PD-L1 targeted agents has been completed, nor have     been initiated combination strategies of CTX, RT and PD1/PD-L1 antibodies in the curative     setting. Taken all data together, a strong rationale may support the combination of     Durvalumab, anti-EGFR therapy such as CTX and RT in order to revert the SCCHN-induced immune     suppression and maximize treatment efficacy, ultimately through enhanced, CTX-mediated immune     mechanisms and maximized RT-specific cytotoxicity.   "
17849|NCT03051893|"     This was an open label, randomised, single dose study, comprising Part A (undertaken in two     separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one     four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers.     The washout interval in both Part A and Part B was 1-week in between each treatment period.   "
17850|NCT03051880|"     The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for     dermatologic adverse events related to EGFR inhibitors.   "
17851|NCT03051867|"     The purpose of the present study is to understand the effect of pregnancy on vitamin D     metabolism and requirements as well as the modulatory role of the placenta in vitamin D     metabolism during pregnancy. In addition, a human placental cell culture model will be     employed to examine vitamin D metabolic flux in human trophoblast cells. The impact of     maternal vitamin D status on maternal and fetal bone health during gestation will also be     examined.   "
17877|NCT03051529|"     This study was conducted on 24 patients who have ischemic dilated cardiomyopathy, underwent     non cardiac surgery in the lower half of the body under the effect of combined spinal     epidural anesthesia at Assiut university hospital. Intraoperative Hemodynamic monitoring     including invasive blood pressure, heart rate, and CVP was established, in addition to pre     and postoperative, 12 lead ECG, echocardiography, and venous sampling for Brain natriuretic     peptide measurement were done .      This study tried to assess the safety of this anesthetic technique on such group of cardiac     patients along over the hospital stay period and up to 6 months postoperatively, in addition     to the predictability of Brain natriuretic peptide as a cardiac biomarker regarding to the     major adverse cardiac events and cardiac mortality for these group of patients .   "
17852|NCT03051854|"     Beside the home, the school is often the second important setting for the development and     education of children and adolescents. Students spend a large part of their life at school.     However, there is recurrent occurrence of violence against children and of harsh discipline     measures used in home and school settings. These may result into negative consequences.     Hence, prevention strategies against the use of harsh discipline use in schools become a     priority.      In the baseline of this study the investigators will therefore examine the prevalence and     consequences of violence against children in Southwestern Uganda. The study will be conducted     in schools and common disciplinary measures used by teachers, and the perceptions of     teachers' and students' in relation to commonly used and experienced disciplinary measures we     will be investigated.      In the second phase, the investigators then will implement and assess the effectiveness of an     intervention aimed at reducing the use of harsh and violent disciplinary measures in schools.     ICC-T training in the long-term aims at fostering better relations amongst students and     teachers. Based on feasibility studies, ICC-T intervention is expected to result into better     teacher-student relationships, change in teachers' attitudes and behaviors concerning the use     of violent disciplinary measures in the school setting.   "
17853|NCT03051841|"     This study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT),     safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination     with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.   "
17854|NCT03051828|"     The data collection of physical evaluations after regular practice of the fencing at patients     having surgically been treated for breast cancer highlighted encouraging results both on the     functional drawing, and on the improvement of the quality of life.   "
17855|NCT03051815|"     Apart from obesity, craniofacial factors are well recognized in the pathogenesis of     obstructive sleep apnea (OSA) and are likely to play an important role in influencing the     response to weight loss. The prevalence of OSA syndrome is as common among the middle-aged     Hong Kong Chinese populations as the Caucasians, despite our Chinese patients having much     lower body mass index (BMI). From previous work on ethnic comparison, for the same degree of     OSA severity, Caucasians were more overweight, whereas Chinese exhibited more craniofacial     bony restriction. Cephalometric measurements based on lateral radiograph of the upper airway     have shown that a shorter distance between maxillary projection from the cranial base, a     smaller posterior airway space, less mandibular protrusion, a narrower space between the hard     palate and cranial base, and a more caudally placed hyoid bone predispose to a higher     apnea-hypopnea index (AHI). A recent study shown that a shorter mandibular length as measured     by lateral cephalometry was associated with a greater fall in AHI after weight loss. Another     study using craniofacial computed tomography (CT) scans to evaluate the maxillomandibular     bony volume found that craniofacial restriction influenced the relationship between weight     loss and OSA improvement. Collectively, these studies suggest that the effect on AHI with     weight loss is likely to be more pronounced in those with a smaller craniofacial skeleton.     However, the effect of the craniofacial restriction on the degree of rebound in OSA following     weight gain after the weight loss intervention is unknown.      The study aims to investigate the change in weight and OSA severity following cessation of a     lifestyle modification program (LMP) and examine the relationship between craniofacial     restriction and the degree of OSA reoccurrence.   "
17856|NCT03051802|"     The scope of this clinical trial is to assess the clinical feasibility of this procedure,     optimize the protocol and perform an initial comparison of the positional accuracy of     navigated endoscopy and applicator insertion versus the standard of care 2D fluoroscopy     protocol.   "
17857|NCT03051789|"     A 4-armed cluster randomised controlled trial conducted among secondary schoolgirls in Siaya,     western Kenya, where clusters are the unit of allocation and schoolgirls the unit of     measurement. The overall aim of the trial is to inform evidence-based policy to develop     intervention programmes which improve adolescent girls' health, school equity and     life-chances. The primary objective is to determine the impact of menstrual cups or cash     transfer alone, or in combination, compared against controls, on a composite of deleterious     outcomes (HIV, HSV-2 infection, and school dropout) over 3 schoolyears follow-up.   "
17858|NCT03051776|"     Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current     therapies have modest results for this condition. Compression garments (CG) prevent the     worsening of lymphedema and even improve it, during periods between treatments of physical     therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence     backs it. The aim of this study is to compare the reduction of lymphedema volume with both     therapies.   "
17859|NCT03051763|"     The aim of this study is to 1) descriptively report possible in flight events and 2) to     provide regression analysis if the number of events are statistically significant in their     prevalence and thus are useful in finding possible parameters in echocardiography, right     heart catheterization, laboratory findings, spiroergometry as well as six minute walk test to     produce a risk assessment for possible expected in flight adverse events as well as a     recommendation concerning the need of supplemental oxygen for each individual patient.      The investigators therefore want to find out:        1. In which subgroup (if applicable) of PH patients in flight adverse events are more          frequent.        2. Whether there are parameters (from blood samples, blood gas analysis, World Health          Organization-Functional Class (WHO-FC), Six Minute Walk (SMW), echocardiography, right          heart catheter (RHC)) that are able to predict in flight need for additional oxygen          and/or possible adverse events.   "
17860|NCT03051750|"     This crossover study compares two different treatment techniques for Breast Cancer-Related     Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.      2. Kinesio Taping.   "
17861|NCT03051737|"     The main objective of this retrospective study is to validate a prediction system of     emergencies department (ED) attendance on a wide range of time and the need for     hospitalization, at various levels of perimeter (with all emergency departments or one ED in     particular), with all patients or with one sub-group of patients (age, gravity, care).   "
17878|NCT03051516|"     This randomized phase IV trial studies how well human papillomavirus (HPV) vaccine therapy     works in interrupting progression in patients with high-grade vulvar or anal lesions.     Vaccines made from HPV peptides or antigens may help the body build an effective immune     response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress or     come back.   "
17862|NCT03051724|"     Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure     (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is     complex. New communication technologies and the current health challenges, such as aging and     high health care costs have encouraged the interest in new strategies.      As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use     internet and mobile technologies usually. However, there is a significant percentage of     patients that does not use Internet and mobile technologies, only the 58% of patients over 65     years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting,     it suggest that it's applicability depends in patient's characteristics and it is necessary     to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why     the investigators believe that the next step should be to choose those patient's that doesn't     use Internet or mobile technologies and to verify the applicability of a telematic system     that could facilitate the extra hospital management of this patient's.      The aim of the study is to evaluate the telematic management of various outcomes that are     emitted by CPAP machine, and by an app where the patient's will answer different questions     regarding their treatment during the three months of study period.   "
17863|NCT03051711|"     To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic     conditions, at Day 15 compared to Baseline.   "
17864|NCT03051698|"     The purpose of this proof-of-concept study is to determine the effect of Intestinal     Microbiota Depletion or Intravenous Administration of C1-inhibitor on Inflammation and     Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide     in Allergic Asthma Patients   "
17865|NCT03051685|"     Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to     determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions   "
17866|NCT03051672|"     This research study is studying radiation therapy in combination with an immunotherapy as a     possible treatment for metastatic hormone receptor (HR) positive, HER2-negative breast     cancer.      The interventions involved in this study are:        -  Palliative Radiotherapy        -  Pembrolizumab   "
17867|NCT03051659|"     This research study is exploring chemotherapy in combination with immunotherapy (a therapy     that uses the body's own immune system to control cancer) as a possible treatment for     metastatic hormone receptor positive breast cancer.   "
17868|NCT03051646|"     Exercise has many benefits for people with multiple sclerosis (MS), such as improved physical     symptoms, mood, fatigue, and cognition. However, many people with MS refrain from exercising     because of the discomfort of exhaustion and overheating that they experience. This study     investigates the use of aspirin before exercise as a treatment to reduce overheating and     exhaustion, thereby availing many more people with MS the opportunity to benefit from     exercise.      The investigators recently published the first-ever report of elevated body temperature in     relapsing-remitting MS (RRMS) patients relative to healthy controls, and elevated temperature     was linked to worse fatigue. This finding that body temperature is elevated and linked to     fatigue in RRMS lays the groundwork for a paradigm shift in our understanding and treatment     of fatigue. That is, the focus shifts from exogenous to endogenous temperature, and from     stimulant medication to cooling treatments.      A recent study comparing healthy adults to adults with MS showed that whereas exercise     increased body temperature in both groups, only in the MS group was it correlated with     exhaustion. The reason for this may relate to the elevation in resting body temperature in     relapsing-remitting MS (RRMS) patients relative to healthy controls. The finding is     clinically meaningful, as elevated body temperature was correlated with worse fatigue in     patients. Exercise Aim: To determine whether pretreatment with ASA (compared to placebo:     within subject crossover design) before exercise results in improved exercise performance     (i.e., increased time-to-exhaustion). The investigators hypothesize that participants will     tolerate exercise for longer after taking ASA than placebo. This hypothesis is based on a)     demonstrated efficacy of antipyretic for reducing body temperature during exercise in healthy     controls, b) demonstrated efficacy of antipyretic for reducing fatigue in non-exercising MS     patients, and c) demonstrated efficacy of elaborate (unblinded) cooling treatments (e.g.,     cooling garments, cooling hand chamber) for improving exercise performance in MS patients.     Note that this project is especially important for MS patients, who have a disease-specific     body temperature elevation and sensitivity to heat (i.e., Uhthoff's).   "
17869|NCT03051633|"     The goal of this project is to test the effectiveness of a successful anti-drug     communications campaign (Be Under your Own Influence) to lower substance use among AI 7th     graders. The campaign uses messages that support youths' personal autonomy and future     aspirations, and these messages are delivered to 7th graders using high school students. Our     goal is to develop a turnkey package for the broader population of AI youth and schools and     to develop components that can incorporate flexibility and creativity in their delivery.   "
17870|NCT03051620|"     The study is a cohort study comprising 140 patients with osteoporosis stopping treatment with     alendronate. The study will contribute with new knowledge about biochemical markers of bone     turnover as predictors of bone loss after stopping treatment with alendronate.   "
17872|NCT03051594|"     1. Three dentinal carious lesions will be chosen in this study and will be in the same          patient.        2. Using local anaesthesia and rubber dam, the operative field will disinfected with 1%          hypochlorite, and the dentine lesions should be exposed with a high-speed diamond bur by          removing covering enamel.        3. Before the excavation dentine samples are collected for baseline bacteriological          assessment .        4. Excavation will be carried out using new slow speed round burs and hand excavators.        5. The excavation end point of one cavity will be determined using visual tactile method.          The two other cavities will be inspected with fluorescent camera or caries detector dye          (CDD) methods to determine excavation endpoint respectively.        6. After excavation, dentine samples from the three cavities will be collected using a          sterile excavator for the bacteriological assessment.             -  Number of visits & follow up period: all procedures will be done at the same visit               and there is no follow up period.      Direct benefit of the research to the human volunteer: to determine the excavation endpoint     to ensure complete caries removal and prevent it's recurrence in the future.      Scientific value and social benefits: to reach the best method to determine the excavation     endpoint.      Expected risk to the human subjects: the ordinary side effects associated with any     restorative treatment and no of the study variable has side effect on the patient and in case     of any side effect due to the restorative treatment, the participant will directly contact     the operator.   "
17873|NCT03051581|"     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of     PTCL can predict disease progression   "
17874|NCT03051568|"     The purpose of this study is to evaluate whether a semi-quantitative interpretation using the     liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression     during chemotherapy or survival in PTCL.   "
17875|NCT03051555|"     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of     NK/T-cell lymphoma can predict disease progression   "
17884|NCT03051438|"     Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising     and exciting approach for minimally invasive thoracic surgery. However, nearly all reported     uniportal VATS lobectomies have been performed via the intercostal route, and chest wall     trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique     involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and     advantages.   "
17885|NCT03051425|"     To investigate the impact of consuming dairy yogurt on immun function including natural     killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in     elderly.   "
17886|NCT03051412|"     Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition in adult females,     which is associated with decreased quality of life and physical activity levels. PFP is     highly persistent, with up to 50% of adolescents reporting persistent pain at both one and     two year follow-ups. Previous research has demonstrated altered pain sensitivity in in older     individuals with chronic pain, however, less is known about this in conditions such as PFP,     which is common in younger populations. Additionally it is unknown if these characteristics     return to similar values as healthy controls, when symptoms resolve.      The aim of this study will be to compare pain sensitivity in individuals with PFP, compared     to those with a previous history of PFP who currently are pain-free, and a control group with     no history of knee pain.   "
17887|NCT03051399|"     Previous in vitro studies suggest that EpiCor is well fermented in the colon and has     prebiotic potential. The repeated long-term administration of low doses of EpiCor in the     Simulator of the Human Intestinal Microbial Ecosystem (SHIME) has shown that this product is     able to induce gradual changes in the colonic environment by: i) being selectively fermented,     leading to butyrate increase in the colon; ii) stimulating Lactobacilli growth in the lumen     and adherence to the mucosal surface, and iii) decreasing potential pathogens. In addition,     the fermentation-derived metabolites produced in the colon were shown to potentially benefit     the host by decreasing cytokine levels in vitro. As a result, the investigators hypothesize     that EpiCor may help to improve bowel function and generally contribute to enhanced gut     health. Therefore, this pilot study is intended to assess the effects of long-term     administration of EpiCor on a population with mild symptoms of intestinal dysfunction.      The primary objective of this exploratory pilot study is to assess the effect of long term     administration of EpiCor on bowel function and gastrointestinal well-being, by means of     validated questionnaires.      This study has 4 secondary objectives: 1) The first secondary objective of this study is to     assess the protective effects of EpiCor on intestinal barrier function, by performing a gut     sugar permeability test in combination with indomethacin challenge; 2) The second secondary     objective is to assess the effects of EpiCor on intestinal barrier function, by measuring     blood Zonulin and endotoxin levels in combination with indomethacin challenge; 3) The third     secondary objective of this study is to assess the prebiotic properties of EpiCor by     collecting fecal samples. The microbial community composition, lactate and SCFA profiles and     proteolytic activity markers in feces will be determined. Proteolytic activity markers will     also be measured in urine samples; 4) The fourth secondary objective of this study is to     assess the effects of EpiCor on local and systemic immune system performance by measuring     secretory IgA levels in feces and cytokines in blood.   "
17888|NCT03051386|"     The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, Live,     Attenuated, dried TC-83, NDBR 102, Lot 4, Run 3, and collect data on the incidence of     occupational VEE virus infection in vaccinated personnel.   "
17889|NCT03051373|"     Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients     with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if     clinical benefits and survival remains limited.      The purpose of this study is to test in a randomized trial enrolling patients for comparing     the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order     to determine the most promising agents as the first line treatment of advanced and/or     metastatic transitional cell carcinoma of urothelial tract.   "
17890|NCT03051360|"     Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower     lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis,     through a randomized controlled trial.   "
17891|NCT03051347|"     This is designated to validate patient-reported outcomes (PRO) measures in itch-specific     pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified     stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis     and other potentially stigmatizing conditions.   "
17892|NCT03051334|"     This study sought to evaluate changes in ascending aorta size after transcatheter aortic     valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients     with tricuspid aortic valve (TAV).   "
17908|NCT03051126|"     To develop a tissue bank library for patients with parathyroid disease who have undergone     surgery and/or biopsy, and/or who may undergo surgical intervention at M. D. Anderson Cancer     Center or outside centers, and/or all patients seen through the Parathyroid Center at     participating sites, whether or not the patients undergo treatment for their disease. The     tissue bank will contain both normal parathyroid tissue and diseased tissue, and will provide     a resource for the ongoing study of parathyroid disease and management.   "
17893|NCT03051321|"     The inability to independently manage perineal hygiene after toileting is a common issue for     those in assisted living and nursing home environments. It is associated with skin breakdown     (dermatitis), increased nursing costs, and loss of patient self-esteem and independence.     Water-based toileting has been evaluated as a possible adjunct to patient care, but its     uptake has been limited by ineffective cleansing and drying.      40 subjects with limitations in independent capacity for perineal hygiene that require     assistance with toileting will be recruited from a continued care retirement center. Subjects     will be assessed for incontinence, and skin breakdown or irritation. Subjects will be     provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to be     applied in cases of dermatitis.      Investigators hypothesize that subjects given the device will remain more independent, with     higher quality of life. Secondary hypotheses are that subjects will experience improved     relationships with their caregivers, and that active dermatitis will be treated in those     already with the condition, and prevented in those at risk.   "
17894|NCT03051308|"     Compare the functionality of new parathyroid transport solution (NPTS) with University of     Wisconsin Solution (UW) on parathyroid glands. Also assess its effects on cell viability,     parathormone (PTH) secretion, calcium-sensing receptor (CaSR) and vitamin D receptor (VDR)     levels during cold ischemia.   "
17915|NCT03051035|"     This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated     dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed     and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a     recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension     cohorts may be conducted to further characterize the safety and tolerability of KO-947 and     provide preliminary evidence of anti-tumor activity.   "
17895|NCT03051295|"     There is little evidence on how best to present diagnostic and treatment effect information     to dentists and whether this makes any difference to their understanding of the information     given and clinical management. The objective of this study is to assess the influence of     different formats for presenting diagnostic test results and treatment efficacy on dentists'     understanding and on their reported clinical management. The hypothesis is that presenting     diagnostic test and treatment effectiveness results using natural frequencies influences the     threshold for treatment and improves interpretation of tests results compared to conditional     probabilities and percentage differences. A group of dentists recruited from postgraduate     courses were randomized to two of four arms, being two arms of a hypothetical realistic     diagnostic scenario (a) and two arms of a hypothetical realistic treatment scenario (b): a1)     diagnostic test results presented in conditional probabilities; a2) diagnostic test results     presented in natural frequencies; b1) treatment efficacy presented in percentages; b2)     treatment efficacy presented in natural frequencies. The main outcome measures were the     correct answer as to whether disease was actually present (post-test probability) and the     correct answer as the number of patients that would benefit from the treatment (efficacy).     Secondary outcome measures included the decision whether to treat or not treat the     hypothetical patient.   "
17896|NCT03051282|"     Angiotensin-converting enzyme inhibitors (ACEIs) are among the most frequently prescribed     medications worldwide for the treatment of essential hypertension, left ventricular systolic     dysfunction, acute myocardial infarction, and prevention of the progression of diabetic     nephropathy. However, the outcome of ACEI treatment varies significantly between individuals     and selected populations. Suboptimal response, therapeutic failure, and significant side     effects are commonly documented in patients receiving ACEI therapy. Approximately 80% of the     ACEIs available for use in the US are synthesized as esterified prodrugs in order to improve     otherwise poor oral bioavailability of the active molecule. The activation of ACEI prodrugs     primarily occurs in the liver via metabolic de-esterification of the parent drug. The     critical activation step is essential in delivering a successful therapeutic outcome since     the active metabolites are approximately 10-1000 times more potent relative to their     respective parent compounds. Carboxylesterase 1 (CES1), the most abundant hydrolase in the     liver, is responsible for the activation of ACEI prodrugs in humans. Marked interindividual     variability in CES1 expression and activity has been documented, which results in varied     therapeutic efficacy and tolerability of many drugs serving as substrates of CES1. Genetic     variation of CES1 is considered to be a major factor contributing to variability in CES1     function. The study team proposes to conduct a multiple-dose healthy volunteer study to     evaluate the impact of CES1 genetic variation on the activation, pharmacokinetics, and     pharmacodynamics of enalapril, a model ACEI prodrug activated by CES1. The completion of this     study will represent a major step towards the establishment of an evidence base from which a     more individualized use of ACEI prodrugs can emerge.   "
17897|NCT03051269|"     In a phase I protocol to primarily investigate the safety of using calcium combined with     electroporation on recurrent head and neck cancers. Secondly, to evaluate tumour response on     PET/MRI (positron emission tomography/magnetic resonance imaging), clinical evaluation,     biopsies. Thirdly, to evaluate the effect of calcium electroporation compared to     electrochemotherapy as well as the patients life-of-quality through questionnaires, EORTC QLQ     C-30 and H&N35 (european organisation for research and treatment of cancer).   "
17898|NCT03051256|"     This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to     assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as     adjunctive therapy in the treatment of patients diagnosed with major depressive disorder     (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have     experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant     medication. This population will provide the opportunity to compare the safety and efficacy     effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the     effects of an antidepressant alone. This study includes in-patient and out-patient periods.   "
17899|NCT03051243|"     Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85     years old with known with history of DM for more than 3 months and an average of two     consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral     antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1     ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with basal     insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine once     daily and glulisine (Apidra; sanifi) before meals.      Patient will be discharged according to discharged protocol. Follow-up visits will take place     at 3 and 6 months post discharged.   "
17909|NCT03051113|"     Neuromas are frequent after trauma and surgery, including amputation and can be identified by     high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is     uncertain. In this observational cohort study, the investigators wish to explore if the     prevalence of neuromas are higher in patients with pain after peripheral nerve injury and     amputation, than in patients with the same conditions but without pain.   "
17910|NCT03051100|"     The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002)     180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients     with elevated LDL cholesterol.   "
17911|NCT03051087|"     to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in     infertility women for assisted reproductive technologies   "
17913|NCT03051061|"     The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with     Atrial Fibrillation (AF) is the hotspot at present. Although the European and American     guidelines have given a hand for us, there is absence of solid evidence-based data on the     safety of antithrombotic therapy in Asian populations. Only a few clinical trials and     registries are available to guide difficult clinical decision making in patients with     combined AF and CHD，the investigators highlight the need for the rapid development of     clinical trials to close the large gaps in evidence. This research aims to know the     real-world use of antithrombotic treatment and clinical prognosis in Coronary Heart Disease     patients complicated with Atrial Fibrillation.   "
17914|NCT03051048|"     Acute myocardial infarction (AMI) pose a pool clinical outcome to men and women whom     treatment was delayed. However, reperfusion time was limited in previous studies. To evaluate     the system delay and clinical outcomes among Chinese patients with AMI, consecutive inpatient     case prospectively collected from 2004 to 2016. Basic data and innovative evidence will     accelerate evidence-based clinical practice and policy making, and improve AMI patients     outcomes finally.   "
17916|NCT03051022|"     The study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an     adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower     extremities.   "
17900|NCT03051230|"     Introduction: Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic phenomenon, poorly     understood and difficult to predict, complicating intense ovarian stimulation cycle. The most     severe symptoms, which associate vascular permeability disorders and hypercoagulability,     occur in 0.2 to 1% of the cases and often require intensive care.      Activation of endothelial, platelet, erythrocyte or leukocyte cells trigger the release of     small specific vesicles, called microparticles, used as markers.      Classically leading to endothelial dysfunction and hypercoagulability, the endothelial     activation phenomenon could constitute the main cause of OHSS or help predict its severity,     as established for various other diseases (cerebral stroke, infarct and lupus…). However, so     far, this endothelial activation role has never been studied.      Objectives:      Evaluate the serum level of microparticles as a predictor of adverse outcomes; correlate it     to hypercoagulability and changes of endothelial permeability associated with this syndrome.      Methodology: Prospective Pilote Cohort study, evaluating before and throughout the ovarian     stimulation cycle (6 samples/patient), the serum modulation of:        -  Endothelial activation markers (endothelial-derived microparticles, E-selectin)        -  Procoagulant markers (microparticles from platelet, erythrocyte or leukocyte origin, Von          Willbrand factor, thrombin-antithrombin complex, prothrombin fragment 1+2)        -  Endothelial disjunction marker (soluble CD 146) A group of 50 patients will be assessed          Techniques: Flow cytometry for measurement of microparticles expressing non specific          (Annexin V) and cell specific surface determinants (CD 31, CD 41, CD 45 or glycophorin          A). Use of commercial kits for other serum markers.   "
17901|NCT03051217|"     The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol     (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese     subjects.   "
17902|NCT03051204|"     Study Aims:      To analyze stool specimens to test and validate the CalproLab assay against the predicate     PhiCal in order to determine performance characteristics.      And to correlate Calpro levels to the gut microbiome composition.   "
17903|NCT03051191|"     Subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared to     general population. The investigators hypothesized that shared molecular mechanism play a     pivotal role in the pathogenesis of CVD including heart failure (HF) and cancers. To address     this hypothesis, the investigators are going to explore the expression pattern of micro RNA     (miRNA) and cell free DNA (cfDNA) derived from host, gut microbiota and gut microbiota     composition extensively in patients with or without CVD, non-ischemic HF (NIHF), and cancers.     The participants will be recruited from the outpatient clinic in Sakakibara Heart Institute     or Japanese Foundation for Cancer Research. By comparing the expression pattern of miRNA,     cfDNA, or gut microbiota composition, the investigators are seeking to find the pathogenic     mechanisms shared by those diseases.   "
17904|NCT03051178|"     The purpose of this study is evaluate the effectiveness and safety of a possible new     treatment for Essential Tremor (ET) using external wearable sensors, which have the     capability of recording acceleration and Electromyography (EMG). This therapy is called     Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer,     and apply stimulation when the computer detects patterns associated with tremor. This     detection will suppress pathological activity and improve or alleviate the tremor.      Currently, DBS is approved for the treatment of ET; however, stimulation is delivered     continuously even when tremor or other symptoms are absent. Continuous DBS can lead to     unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS     will turn on only if activity associated with ET from the external sensors is detected.   "
17905|NCT03051165|"     This study will evaluate the effect of hypoglossal nerve stimulation (HGNS) on different     measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People     with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study     site will be told about the study at their 2-week post-operative appointment. Those who     decide to participate will have blood drawn and vascular function measurements taken before     HGNS activation, during treatment, and after a temporary treatment withdrawal period.     Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.   "
17906|NCT03051152|"     Background: Literature often shows limited and discordant data regarding the prognostic value     of age in gastric-cancer patients. Generally, disease-specific survival does not seem to be     worse in the elderly when compared with younger patients, and therefore gastrectomy with     extended lymphadenectomy for non-early tumors is considered the standard surgical therapy     for all of operable patients, despite any age- or comorbidity-related limitations. Recent     trials reported a survival benefit for extended nodal dissection compared with the more     limited method, but some Authors found age (and comorbidities) to be a relevant predictor of     postoperative complications, conditioning the safety of the surgical procedure itself.      Methods/Design: The LELEGA Trial (Limited versus Extended Lymphadenectomy in high risk     Elderly with Gastric Adenocarcinoma) is a randomized, clinical multicenter trial. All     patients >75 years and with Charlson Comorbidity Score >5 with resectable M0 gastric cancer     are eligible for inclusion and randomization. The primary endpoint is 5-year Disease-Specific     Survival (DSS). Secondary endpoints include 5-year Overall Survival (OS) and postoperative     complications classified according to Clavien-Dindo. Assuming an alpha (two-sided) of 5%, 232     patients per group are necessary to achieve an 80% power to detect a 13% survival difference     (from 56% to 69%) between groups.      Discussion: LELEGA trial is a prospective, multicenter randomized study to define optimal     extent of lymphadenectomy (extended versus limited) in elderly and high-comorbidity gastric     cancer patients.   "
17907|NCT03051139|"     The primary objective of this study is to evaluate whether a multi-component implementation     strategy/quality improvement intervention comprised of 1) clinical decision support that     couples a natural language processing (NLP) acute respiratory distress syndrome (ARDS)     recognition tool with a clinician alert system, and 2) audit and feedback improves the     implementation of low tidal volume ventilation (LTVV) for patients with the acute respiratory     distress syndrome (ARDS). This will be accomplished with a cluster randomized controlled     trial comparing the implementation strategy to usual care   "
17912|NCT03051074|"     The studies proposed in this protocol aim to explore the anxiolytic properties of floating as     it relates to the central and autonomic nervous system.   "
17917|NCT03051009|"     Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of     subjects with nocturia due to nocturnal polyuria, for up to 1 year   "
17918|NCT03050996|"     Urinary continence recovery remains one of the most bothersome side effect of modern radical     prostate surgery and several technical modifications, especially in Robotic assisted radical     prostatectomy procedures, have been reported in order to improve early urinary continence     recovery.      With the aim to improve the urinary continence recovery after robotic prostatectomy, we     evaluate the impact of the use of a 6-branch retropubic suburethral autologous sling, created     and placed during the procedure, in association with intraoperative evaluation of the     retrograde leak point pressure by means of retrograde perfusion sphincterometry for proper     sling tensioning.   "
17919|NCT03050983|"     Single site prospective observational nested study of bedside CS20p monitor on the GCF     impeded into a retrospective review of the frequency of escalation of care with intermittent     vitals signs compared to continuous respiratory monitoring.   "
17920|NCT03050970|"     The purpose of this study is to validate a clinical decision rule for the management of minor     head trauma in infants aged less than two years, constructed with the intention of minimizing     the rate of computed tomography scans ordering.   "
17921|NCT03050957|"     Oropharyngeal dysphagia (OD) is the most frequent digestive disorder in older people (>70     years) and has been recently recognized as a geriatric syndrome. The main features of OD are:     a high prevalence and severe complications either related with the decreased swallowing     efficacy with 45% prevalence of malnutrition or due to decreased swallowing safety with 50%     prevalence of aspiration pneumonia that increases hospital stay by 100% and leads to a 50% of     mortality rate. However, there is no specific pharmacologic treatment for OD in older     patients yet. Treatments are now evolving from compensation to active treatments aiming to     restore the swallowing dysfunction and some groups have been looking for new therapeutic     strategies. The main goal of this study is to evaluate the effect of administering menthol in     bolus on the swallowing response in elderly and neurogenic patients with OD. In addition,     this study will also assess the side effects of this pharmacological strategy.   "
17922|NCT03050944|"     Infertility affects one of every six couples and one out of ten couples may seek fertility     treatment such as ovulation induction and assisted reproductive technologies. With respect to     diet, several dietary factors, i.e. micro-, macro-nutrients and individual food groups, have     been associated with the risk of subfertility; however, more information is needed on the     role of dietary factors in reproductive functions. However, evidence concerning the     association between dietary patterns, such as the Mediterranean diet (MD) pattern, and     fertility is scarce. The aim of this study is to investigate the relationship between     preconception dietary patterns, especially the MD pattern, and in vitro fertilization (IVF)     outcomes, as well as adiponectin and follistatin concentrations in the plasma and follicular     fluid of women undergoing IVF treatment. Blood and follicular fluid adiponectin and     follistatin concentrations will be measured on each day of the ovarian stimulation protocol.     Main IVF treatment outcomes are fertilization rate, oocyte and embryo quality, implantation,     clinical pregnancy and live birth rates.   "
17923|NCT03050931|"     The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can     produce reproducible and accurate images in people with epilepsy compared to existing     standards such as MRI, CT or EEG.      Electrical Impedance Tomography is a relatively new medical imaging method, which has the     potential to provide novel images of brain function. It is fast, portable, safe and     inexpensive, but currently has a relatively poor spatial resolution. It produces images of     the internal electrical impedance of a subject with epilepsy using rings of ECG like     electrodes on the skin, intracranial electrode mats or deep electrodes implemented surgically     as part of clinical assessment. EIT recording will take place in parallel with the routine     recording on the ward. Following completion of the recording, the EIT images will     subsequently be analysed and compared to other imaging data for accuracy.   "
17924|NCT03050918|"     The goal of this project is to quantify the impact of post-hospital discharge follow-up phone     calls on hospital readmission, ED visits, patient satisfaction, and mortality in a general     medicine inpatient population. We will obtain exploratory information on patient sub-groups     at high risk for hospital readmission and on those experiencing high benefit from the     follow-up phone call intervention. In addition, we will obtain data on discharge plan     implementation assistance needed to support a successful transition from inpatient to     outpatient care among those reached by the intervention phone call.   "
17925|NCT03050905|"     HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular     carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype     displays a different geographic distribution.      Since different HCV genotypes react differently on available antiviral therapies, the correct     identification of HCV genotype serves as a marker of responsiveness and an indicator for     duration of treatment.      The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002.      A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical     laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This     assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these     findings, the number of patients with 2k/1b may be underestimated.      AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3     DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV     proteins essential for viral replication. The high efficacy of the 3D regimen was proven in     registration clinical trials and RW for 1b population.      3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective      • Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an     interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b.      Study Design:      .The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label     recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will     receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for     antiviral response, clinical outcomes, patient reported adverse events and presence and     emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of     treatment and extra 24 weeks of follow up. Scheduled visits will include: physician     assessment and blood tests including HCV resistance mutations.   "
17926|NCT03050892|"     Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day     recipient mortality in order to improve graft screening.   "
17927|NCT03050879|"     The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer     using in laparoscopic gastrectomy with lymph node dissection for gastric     adenocarcinoma（cT1-4a, N-/+, M0）.   "
17928|NCT03050866|"     After failure on docetaxel, which has been the standard first line therapy for patients with     metastatic castration-resistant prostate cancer (mCRPC), several treatment options are     currently available.      In retrospective studies, resistance has been described to two of the treatment options,     enzalutamide and abiraterone, when a splice variant of the Androgen Receptor (AR-V7) is     present on circulating tumor cells (CTCs). The investigators hypothesize that patients with     AR-V7 positive CTCs do have a meaningful response to cabazitaxel.   "
17929|NCT03050853|"     This study will evaluate behavioral and psychological appeal, toxicity, and effect of     e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious     mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be     enrolled and randomly assigned to either receive a supply of e-cigarettes for 8 weeks plus     assessments (baseline & weeks 2, 4, 6, 8, 13, & 26) or assessments only. This single-blinded     study will provide e-cigarettes and instructions on their safe use. Level of appeal will be     inferred from carefully assessed use of e-cigarettes and reduction in combustible tobacco.     Qualitative data will also be collected from participants assigned to e-cigarettes, given     that unanticipated issues will almost certainly arise in connection with e-cigarette use that     can only be captured within a qualitative debriefing at the conclusion of participants' time     in the study.   "
17930|NCT03050840|"     Obesity [Body mass index (BMI kg/m2 ≥ 95th percentile)] affects 1 in 5 adolescents in the     United States, with 13 million suffering from severe obesity (BMI ≥ 120% > 95th percentile or     ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and     physical activity, but change in these behaviors requires self-monitoring and support, and     weight loss is not always successful.      Parent involvement and parent weight-loss can help their children to lose weight and     successfully change their behavior. Guidance from pediatricians can also help to facilitate     weight loss among obese adolescents. That said, treatment of obesity through behavior change     within the time constraints of a Pediatric practice visit is limited by treatment adherence     and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep     adolescents with severe obesity engaged in therapy outside of standard practice is a critical     need.      The effects of monetary incentives through games (gamification), and a comprehensive remote     digital monitoring system on sleep, physical activity, and dietary intake, has been     successful in adults, but has not been tested in adolescents with obesity.   "
17931|NCT03050827|"     Investigators propose a placebo controlled, double blinded study to examine efficacy of     topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type 2     diabetic subjects with established peripheral neuropathy. This site most clearly demonstrated     efficacy of topiramate in reversing IENF loss within 18 weeks in our prior study. Subjects     will also undergo quantitative sensory testing (QST) and assays of laser Doppler skin blood     flow (SkBF), neuropathy total symptom score (NTSS-6), and quality of life (Norfolk QOL-DN),     along with standard measures of physiology and fasting blood chemistry. Subjects with IENF     loss of between 20-75% of normative values and thus amenable to therapy-induced recovery,     will be randomized into placebo (N=30) or active drug (N=30) arms and instructed in how to     apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 in2 region of skin adjacent to the     initial biopsy site, as per the manufacturers instructions (http://www.gelnique.com/gel3/).     Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance.     After 20 weeks, subjects will return for a second series of measurements and 3 mm skin biopsy     from the treated region of skin.   "
17942|NCT03050671|"     This study aims to compare two different external calf compression devices applied in healthy     individuals. These devices are commonly used in medical care in order to prevent the     formation of blood clots, for example during immobilization after surgery. We aim to confirm     the effects of external cyclic compression on healing and blood clotting and also to identify     the one which is more effective.   "
17962|NCT03050411|"     Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib     demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients     with EGFR mutations. However, patients who are initially sensitive to the drugs eventually     become resistance. Apatinib is a highly selective VEGFR2 inhibitor and reduces the     angiogenesis of tumor efficiently. In this study, the investigators aim to explore the     efficacy and reasonable dosage of apatinib combining with EGFR-TKI in advanced non-squamous     non-small cell lung cancer with EGFR-TKI resistance.   "
17963|NCT03050398|"     This study will allow for the collection of tumor tissue samples to better understand     relevant mutations and the mechanisms responsible for resistance to treatment.   "
36712|NCT02805140|"     The purpose of this study is to test feasibility and acceptability of an online platform that     uses mobile apps and videoconferencing tools to increase activity levels in mothers with     young children.   "
17932|NCT03050814|"     Background:      Colorectal cancer is a common cancer in the U.S. It causes the second most cancer-related     deaths. The drug avelumab and vaccine Ad-CEA together help the immune system fight cancer.      Objective:      To test if avelumab and Ad-CEA plus standard therapy treats colorectal cancer that has spread     to other sites better than standard therapy alone.      Eligibility:      People ages 18 and older with untreated colorectal cancer that has spread in the body      Design:      Participants will be screened with:      Test to see if their cancer has a certain deficiency      Blood, urine, and heart tests      Scans      Medical history      Physical exam      Tumor sample. This can be from a previous procedure.      A small group of participants will get Ad-CEA and avelumab plus standard therapy. This is     FOLFOX plus bevacizumab for up to 24 weeks then capecitabine plus bevacizumab.      The others will have treatment in 2-week cycles. They will be Arm A or B:      Arm A: FOLFOX and bevacizumab by IV days 1 and 2 for 12 cycles. After that, capecitabine by     mouth twice a day and bevacizumab by IV on day 1.      Arm B: Ad-CEA injection every 2-12 weeks. Avelumab by IV on day 1 of each cycle. FOLFOX and     bevacizumab by IV days 2 and 3 for 12 cycles. Then, capecitabine by mouth twice a day and     bevacizumab through IV on day 2.      Participants will repeat screening tests during the study.      Participants will be treated until their disease gets worse or they have bad side effects.     Arm A participants can join Arm B. They will have a visit 4 5 weeks after they stop therapy.   "
17952|NCT03050541|"     The purpose of this study is to examine the effects of MDMA on encoding and retrieval of     emotional and social memories in healthy young adults. The study will explore the effects on     memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.   "
17968|NCT03050333|"     An observational, prospective, multicentre and international study. This will be a     non-interventional study to evaluate the efficacy and safety of endoscopic resection of     gastrointestinal lesions and to determine what are the factors related to complications, and     to describe these lesions according to the different morphologic and histologic     classifications.   "
17933|NCT03050801|"     Background:      Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to     problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help     improve connections between brain areas in healthy people. Researchers want to see if it can     be useful in patients with memory problems after TBI.      Objective:      To see how repetitive transcranial magnetic stimulation can be used to improve the     connections between parts of the brain and whether this will lead to changes in memory.      Eligibility:      Adults 18-50 years old with TBI who can speak and write in English.      Healthy volunteers the same age and English ability.      Design:      Participants will be screened with a neurological exam and may have a urine pregnancy test.      Participants with TBI will have 7-15 visits. Healthy volunteers will have 2-8.      At the visits, participants will have all or some of the following:        -  MRI for about 1 hour. They will lie in a machine that takes pictures in a magnetic          field. They will do some memory tasks.        -  Memory and attention tasks with pictures and with a computer        -  Questions about their mental state and well-being        -  TMS: A wire coil is held on the scalp and a short electrical current passes through it.          Participants will hear a click and feel a pulling or twitch. They may be asked to make          simple movements. rTMS is repeated magnetic pulses in short bursts. They will have this          for about 20 minutes.      A week after the last visit, some participants will return for a memory test.   "
17934|NCT03050788|"     The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS)     that may be eventually deployed with portable, point-of-care techniques. This approach     features confocal microscopy. The investigators will compare this new approach with the gold     standard of histology from a traditional skin punch biopsy (which is standard of care) to     determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.   "
17935|NCT03050775|"     The purpose of this study is to evaluate patients' temperatures after using one of two     ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™     system) or the standard ventilator circuit with a heat-moisture exchanger (standard     ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through     their breathing tube while the standard ventilator will not. The investigators are doing this     research study to find out if the ventilator circuit providing additional heat and humidity     will keep patients warmer during surgery and after surgery.   "
17936|NCT03050762|"     The goal of this data review study is to collect data to learn more about thyroid,     parathyroid, and adrenal disease.   "
17937|NCT03050749|"     In this study, eligible patients with the medical indications (facial lipoatrophy,     morphological asymmetry of the face, or debilitating scars) will be treated with Princess®     VOLUME, and then will return for follow-up assessments 2, 4, 24, and 36 weeks after the     treatment. A touch-up treatment may be done 2 weeks after the treatment if deemed appropriate     by the Investigator.   "
17938|NCT03050736|"     The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the     maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation     regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the     methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be     explored and tumor responses to treatment will be evaluated.   "
17939|NCT03050723|"     In this study, eligible patients with the medical indications (facial lipoatrophy,     morphological asymmetry of the face, or debilitating scars) will be treated with Princess®     FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment.     A touch-up treatment may be done 2 weeks after the treatment.   "
17940|NCT03050710|"     In this study, eligible subjects with moderate to severe nasolabial folds will be treated     with Princess® VOLUME Lidocaine and will return for follow-up assessments 2, 4, 24 and 36     weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate     by the investigator.   "
17941|NCT03050684|"     Investigators will use dinoprostone(Propess TM) for cervix ripening and labor induction in     term pregnant women.Vaginal pH base is achieved with the effect of hormones in pregnancy and     associated with this, vaginal infections rates increase. With the vaginal application of     Propess, the preparate remains in the vagina for a long time, with controlled     release,creating a film layer against bacteria and especially fungal infections and it was     thought that this could be a reason for unsuccessful birth induction by preventing release of     this ovule.      The aim of this study is to observe whether or not the rate of caesareans with the indication     of unsuccessful induction was reduced in patients by reducing the density of vaginal bacteria     and fungi with vaginal lavage and thereby increasing the effect of the drug and decreasing     the rate of unsuccessful inductions.   "
17964|NCT03050385|"     The purpose of this study is to explore whether active transcranial direct current     stimulation during cognitive rehabilitation tasks can boost cognitive enhancement without     severe side effects in mild cognitive impairment or mild dementia patients.   "
17943|NCT03050658|"     Atopic dermatitis (AD) is a chronic allergic skin disease with onset in early childhood and     increasing prevalence in Westernized countries. Current well newborn guidelines for washing     babies with soap were adopted by U.S. hospitals in the 1970s, before the rise in prevalence     of allergic disease and AD (also called eczema). Increased transepidermal water-loss (TEWL)     in newborn skin at 2 days of life was recently identified as a predictor of AD and allergy     development by age 2 years. Risk for AD in babies was also linked to decreased skin     colonization with certain skin microflora, such as staphylococcal organisms. Together, these     data raise the question of whether newborn skincare guidelines have the potential to modify a     baby's risk for allergy development. Our current practice of washing babies with soap may     alter TEWL or other natural factors in skin that protect babies from development of AD and     allergy. More knowledge is needed about the impact of infant skincare practices on allergy     development.      The objective of this pilot study is to determine the impact of a baby's first bath on     his/her transepidermal water loss (TEWL) and skin microflora. Study procedures will include     collection of TEWL measurements and skin swabs for skin microflora analysis pre/post first     bath in healthy term newborns at UVA. This data will serve as preliminary data for future     studies.   "
18297|NCT03046043|"     The purpose of this study is to evaluate the efficacy of additional ablation targeting     complex fractionated atrial electrogram area within low voltage zone identified by high     resolution mapping in patients with persistent atrial fibrillation.   "
17944|NCT03050645|"     Women with previous Gestational Diabetes Mellitus (GDM) are characterized by several     metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of     later Diabetes Mellitus (DM). These latent disorders of glucose metabolism are demasked by     the metabolic stress of pregnancy and as a routine, clinical assessment and measurement of     HbA1c in addition to an oral glucose tolerance test (OGTT) is offered 3 months post partum.      In this study, women with previous GDM and a control group matched on age, time of birth and     BMI around 8 years after pregnancy will be investigated. Information from pregnancy and post     partum examination (GDM only) will be used to identify risk factors for later development of     DM. Further, life-style factors and mental health according to diabetes status will be     studied.   "
17945|NCT03050632|"     The investigators are interested about the degree to which individuals can persist with     individualized treatment goals when their cues (external such as food, or internal such as     anxiety) are high for impulsive/maladaptive behavior (e.g., purging, not eating, etc.). The     investigators want to find specific high-difficulty situations in which to assess whether     participants remain mindful of the big picture and are willing to work toward therapeutic     goals. Also, the investigators want to rate the participants degree of success (e.g.,     proportion of calories eaten) assessed more objectively.      The theory is that working memory capacity (WMC) modulates the ability to keep longer-term     goals in mind when faced by current stress/temptations. For example, the ability to control     drinking when one has an implicit urge to drink is predicted by WMC. The ability to apply a     novel emotional regulation skill at a time of stress is also predicted by WMC. Indeed, the     generic ability to pursue goals in the future (as assessed by the discounting of the value of     future goals) is reliably predicted by WMC. There is also evidence that activation of brain     regions associated with WMC (by direct activation of the dorsolateral prefrontal cortex via     transcranial magnetic stimulation (TMS), or by having a person complete a relevant cognitive     task) improves delay discounting.      Accordingly, the investigators are proposing a study that both assesses the link between WMC     and relevant the clinical measures noted above, as well as changes in these measures     following activation of WM with a cognitive prime (WM task). The overall design calls for an     initial WMC assessment, followed by randomization to complete 3 days of a WM prime and then 3     days of a no prime group, or vice versa. The investigators then assess the clinical outcomes     noted above across the following 6 days, with a WM prime first or no prime first occurring     prior to the targeted behaviors. The investigators will prime WM prior to participant's     evening meal, with the WM intervention offered during the free time before this meal.   "
17946|NCT03050619|"     Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the     United Kingdom (UK) in August 2014. It can be expected that patients initiating empagliflozin     may differ in their characteristics from patients initiating other glucose lowering drugs     (GLDs) that have been on the market longer (e.g. patients may have poorer glucose control).     Therefore, the proposed study aims to characterize patients with T2DM in the UK initiating     empagliflozin in terms of baseline characteristics, concomitant medications, and     comorbidities compared to patients with type 2 diabetes mellitus (T2DM) initiating other     SGLT-2 inhibitors or other non-insulin GLDs. Due to the mode of action, some patients taking     empagliflozin have experienced weight loss in clinical trials. A theoretical possibility     exists that empagliflozin may be used by patients without T2DM. Therefore, this study also     aims to assess the potential off-label use of empagliflozin compared to other non-insulin     GLDs.   "
17947|NCT03050606|"     Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain,     hyperalgesia and allodynia. Physical exercises are recommended as the first choice of     non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness     and cost-effectiveness of modified Pilates method exercises compared to aerobic exercises in     the treatment of patients with fibromyalgia. The hypothesis is that Pilates exercises will be     as effective as aerobic exercise in the improvement of clinical outcomes, and that this     improvement will be maintained over the medium to long term. It is also expected that aerobic     exercises will be more cost-effective.   "
17948|NCT03050593|"     The investigators wish to test a hypothesis that patients with HFpEF have different     characteristics on echo, cardiac MRI and plasma protein & chemical profiles compared to HFrEF     and healthy volunteers.   "
17949|NCT03050580|"     This is cluster randomized control trial, that aims to evaluate the effectiveness of the     treatment group model for abused women in enhancing their self-esteem and reducing the level     of depression, in three shelters for abused women of Po Leung Kuk (a social service     organization in Hong Kong). It is hypothesized that subjects in the Treatment Group would     report significant improvement in self-esteem, social support, quality of life; reduction in     the level of depression, symptoms of Posttraumatic Stress Disorder at 3 months after service     delivery.   "
17950|NCT03050567|"     Hardening of the neck vessels (carotid arteries) caused by fatty deposits called 'plaques' is     a common cause of strokes. Over time plaques can burst or may lead to a severe narrowing     (stenosis) of the neck artery. When plaques burst, small clots or fatty particles (called     microemboli) break off, block brain vessels and lead to a stroke. Researchers have an     incomplete understanding of the processes that cause hardening of the arteries, development     of small clots and are unable to predict who will have a stroke. At present, the only     ultrasound scan that evaluates circulation in the head and detects these small clots is     called the Transcranial Doppler ultrasound. The aim of the study is to test this simple     ultrasound technique to see if it can detect signals that may correspond to these small clots     or fatty particles. The other objective is to see how repeatable the ultrasound technique is.     This may help to identify patients with hardened neck arteries who are at higher risk of a     recurrent stroke. This could also potentially improve patients selection to a targeted     surgical or future novel pharmacological therapy.   "
17951|NCT03050554|"     The purpose of the study is to determine whether avelumab has an effect on cancer and body in     combination with SBRT, a standard treatment for early stage non-small cell lung cancer     (NSCLC).      Avelumab is considered experimental because it is not approved by the United States (U.S.)     Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a     monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target     and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to     block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this     interaction, the immune system may be stimulated, allowing it to more effectively recognize     and attack the cancer.      Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting     to deliver a high dose of radiation to the tumor over a short period of time. A positioning     cushion such as Vac-lok will be used during radiation treatment that is custom made. This     custom mold forms to the contours of the subjects body to allow for proper positioning     comfort and stability.   "
21423|NCT03004170|"     The purpose of this study is to determine if a brief behavioral intervention delivered over     the telephone is effective at reducing occasions of condomless sex in persons living and     aging with HIV.   "
17953|NCT03050528|"     The aim of this study is to evaluate the effectiveness of a combined Exercise and Acceptance     and Commitment Therapy (ACT) programme, compared to a standalone supervised exercise     intervention for patients with chronic pain. Chronic pain is a common problem, which can have     a significant impact on quality of life. While there are many treatments available for     chronic pain, research has shown that improvements are often modest and short-term.      Exercise therapy is known to be helpful for many chronic conditions and is recommended in     clinical guidelines for the management of chronic pain. Acceptance and Commitment Therapy     (ACT) is a form of psychological therapy, which focuses on improvement of function, rather     than symptom reduction. There is an emphasis on psychological flexibility, values and     mindfulness. This approach may be well suited to chronic pain, where symptoms can be beyond a     person's control, but there is a need for further research, particularly with regards to     combining ACT with a physical intervention.      This study will take place in a Dublin University hospital. Patients will be randomly     allocated to a combined exercise and ACT treatment group or a standalone exercise group. Both     groups will have weekly treatment for eight weeks and will be assessed before and after     treatment, and again twelve weeks later. Questionnaires will be used to measure the effects     of the treatment on the degree to which pain interferes with various aspects of daily life.     Activity trackers will be worn to measure daily physical activity levels. A purposeful sample     of participants from both groups will also be invited to participate in a qualitative study     following treatment.   "
17954|NCT03050515|"     Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging     population. Almost 50% of women have at least one urinary tract infection in their lifetime;     following this first infection, there is a 25-35% chance that she will have another infection     in the subsequent 3-6 months. With each documented infection, a patient receives anywhere     from a three to seven day course of antibiotics for treatment. Repeated courses of     antibiotics often lead to the development of multi-drug resistant infections that are     difficult to treat with our arsenal of oral medications. It is theorized that most, if not     all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If     there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will     likely be difficult to ever adequately treat repeat urinary tract infections. This same     theory led to the development and utilization of fecal microbiota transplantation in the     treatment of refractory Clostridium difficile diarrhea. There are now several studies that     have reported on the efficacy of fecal transplantation in the treatment of C.difficile     infections as well as the correction of gut dysbiosis. Given this positive response in     treatment of refractory infectious diarrhea, the investigators propose that the correction of     gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore, the     investigators propose this pilot study to determine the effectiveness of fecal     transplantation in the treatment of refractory, recurrent urinary tract infections.   "
17955|NCT03050502|"     Chest injuries are common in patients with polytrauma and are responsible for approximate 25%     of all trauma-related mortalities. Traumatic injuries to the thorax often result in the     accumulation of blood within the chest (i.e. a hemothorax (HTX)). The management of HTX     remains a clinical dilemma when the volume of blood is small to moderate and the patient is     hemodynamically stable. The East American Association of Trauma guidelines suggest that all     HTXs should be considered for chest tube drainage. However, a prospective observational study     suggested small to moderate HTXs could be absorbed without intervention. Although HTXs are     effectively managed with chest tube drainage of the blood (i.e. tube thoracostomy), this     intervention is associated with numerous potential major complications, including injury and     infection in up to 22% of patients. The purpose of this study is therefore to conduct a     randomized controlled study to compare patients with traumatic HTX managed by chest tube     drain or expectant management (close monitoring), to determine when a chest tube is needed     and when it is not to treat hemothoraces. The results from this study will inform the care of     future trauma patients who present with this common injury throughout the globe.   "
17956|NCT03050489|"     Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.   "
17957|NCT03050476|"     Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute     kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.   "
17958|NCT03050463|"     The investigators hope to gain a better understanding of the influence of affect reactivity     and regulation on the decision of newly diagnosed breast cancer patients to choose bilateral     mastectomy. The information gained can help develop an intervention to enable management of     cancer-related anxiety by non-surgical means.   "
17959|NCT03050450|"     Independently, both lenalidomide and vorinostat have shown promising activity in pediatric     central nervous system tumors. These are both agents that are not typically part of     first-line studies, although both agents are of serious interest and are currently in     clinical trials for further investigation. This study is to evaluate the combination of     lenalidomide and vorinostat in high grade or progressive central nervous system tumors in     children.   "
17965|NCT03050372|"     Participants will be recruited and screened through ongoing studies in the sleep and anxiety     disorders clinic. Participants with insomnia will be consented to complete several     questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of     active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study.     Each of the two treatment conditions (active versus sham) will be conducted on two     consecutive nights. There will be no more than 7 days between the adaptation night and the     first treatment condition and no more than 7 nights between each of the two-night treatment     conditions . Thus, each participant who completes the full study will spend a total of 5     nights in the sleep laboratory and the time interval from the first adaptation night to     completion of the study may range from 5-19 days for any particular individual.   "
17966|NCT03050359|"     The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus     lansoprazole in the treatment of participants with duodenal ulcer.   "
17967|NCT03050346|"     This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol,     combined with a specific breathing maneuver to identify myocardial regions exposed to severe     coronary artery stenosis.   "
21906|NCT02998866|"     To determine the correlation between rate of temperature decline and nadir cryoballoon     temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary     vein isolation.   "
17969|NCT03050320|"     The purpose of this study is to examine the impact of an OA-specific aerobic and     strengthening exercise program, delivered within the workplace, on mobility, pain, physical     capacity, and resilience among workers with knee or hip OA as well as those with no joint     pain. The investigators hypothesize that exercise designed for OA, delivered at work, will     improve all of these outcomes.   "
17970|NCT03050307|"     The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus     lansoprazole in the treatment of participants with gastric ulcer.   "
17971|NCT03050294|"     Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a     significant amount of patients in most dermatological practices. Topical corticosteroid     agents are often prescribed for treatment of both these conditions, especially when they are     localized rather than wide spread. The development of resistance to treatment is termed     tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary     cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to     determine, under conditions designed to assure good adherence, whether topical 0.25%     desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory     skin disease defined by failure of previous topical steroid treatment.   "
17972|NCT03050281|"     Background: The use of simulation and cadaveric laboratory training are highly beneficial for     faculty and advanced trainees, but its usefulness for third-year medical students rotating     through OB-GYN or general surgery is unknown.      Objective: To determine if a two-day intensive, cost-effective review of procedural skills     and anatomy using the simulation laboratory and cadaver-based dissection improves performance     of third-year medical students on the National Board of Medical Examiners (NBME) Shelf and     USMLE Step 2 board examination and during pre- and post-test demonstrations.      Significance: If proven effective, implementation of a short, inexpensive, and comprehensive     course highlighting anatomical and procedural skills during the third year of medical school     could be implemented.      Design Methods: The investigators will conduct a 1:1 randomization of third-year medical     students rotating at all Mayo sites (Jacksonville, Rochester, and Scottsdale). The students     will either participate in traditional education (N=20) as is currently taking place or     traditional education plus cadaver-based/simulation-based learning (N=20). Third-year medical     students rotating in OB-GYN or surgery will be eligible to enroll.      Anticipated Outcomes: Knowledge-based examination results as well as performance outcomes     will be improved and procedural skills and overall satisfaction will be increased.   "
17973|NCT03050268|"     NOTE: This is a research study and is not meant to be a substitute for clinical genetic     testing. Families may never receive results from the study or may receive results many years     from the time they enroll. If you are interested in clinical testing please consider seeing a     local genetic counselor or other genetics professional. If you have already had clinical     genetic testing and meet eligibility criteria for the this study as shown in the Eligibility     Section, you may enroll regardless of the results of your clinical genetic testing.      While it is well recognized that hereditary factors contribute to the development of a subset     of human cancers, the cause for many cancers remains unknown. The application of next     generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary     cancer predisposition. Currently, more than 100 cancer predisposing genes have been     identified, and it is now estimated that approximately 10% of all cancer patients have an     underlying genetic predisposition.      The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic     variants. For this study, the investigators will establish a Data Registry linked to a     Repository of biological samples. Health information, blood samples and occasionally leftover     tumor samples will be collected from individuals with familial cancer. The investigators will     use NGS approaches to find changes in genes that may be important in the development of     familial cancer. The information gained from this study may provide new and better ways to     diagnose and care for people with hereditary cancer.      PRIMARY OBJECTIVE:        -  Establish a registry of families with clustering of cancer in which clinical data are          linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues          from the proband and other family members.      SECONDARY OBJECTIVE:        -  Identify novel cancer predisposing genes and/or genetic variants in families with          clustering of cancer for which the underlying genetic basis is unknown.   "
17974|NCT03050255|"     Although exercise-induced desaturation is frequently observed in patients with idiopathic     pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not     been investigated yet. Given, that walking ability is the most important activity of daily     life, the aim of our study is to investigate the effects of supplemental oxygen on endurance     walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance     shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air     (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a     double-blinded fashion and random order.      Since there are only limited pharmacological treatment options for IPF patients, this study     may help to provide novel information about the short-term effects of supplemental oxygen.     Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to     facilitate patients´ participation in activities of daily life and not at least to improve     patients´ quality of life.   "
18171|NCT03047681|"     An association between mast cells and outcomes of patients undergoing transcatheter aortic     valve replacement (TAVR) has not been studied to our knowledge. We aim to characterize     tryptase levels dynamics during TAVR; Demonstrate whether tryptase level post-TAVR can be     used as a prognostic marker.   "
17975|NCT03050242|"     This study is intended to evaluate the efficacy and safety of glycopyrrolate as an     antisialagogue prior to intubation with the rigid-videostylet(Optiscope®) in the general     anesthesia settings. Upper airway secretions limit the use of the videostylet during during     endotracheal intubation. Therefore, in this study, patients will be allocated to either of     the two groups according to the administration of glycopyrrolate and the effect of     glycopyrrolate in reducing oral secretions will be assessed by the observer while intubating     with the rigid-videostylet. The efficacy of the antisialagogic effect on the view during     endotracheal intubation will be evaluated.   "
17976|NCT03050229|"     To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB'     on the reduction of nocturnal blood pressure in T2DM with hypertension   "
17977|NCT03050216|"     This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted,     ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after     lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute     myelogenous leukemia (AML).   "
18175|NCT03047629|"     This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and     pharmacodynamics of an orally-administered medication to relieve symptoms of constipation     associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be     studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be     studied over an 8-10 week period. All subjects will receive the study drug during one of the     observational periods of the study.   "
17978|NCT03050203|"     Recent evidence suggests the efficacy of custom pack procedure on the operators reduction     time and on the contamination risk due to the opening of many sterile packs. Nevertheless     ,the studies available are sponsored by the industry and their results are very few. The aim     of this study is to evaluate the correlation and reliability of spine surgery custom pack     efficacy in adult patients obtained in the reduction of surgery time, relative risks, and     materials wasted compared with the standard surgical field procedure practice .   "
17979|NCT03050190|"     The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor     gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies.     Clinical response and development of a standardized lentiviral vector and cell production     protocol will be investigated. This is a phase I/II trial enrolling patients from multiple     clinical centers.   "
17980|NCT03050177|"     The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence     Study. During each session, the subjects will be administered a single dose of 250mg     Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of     AstraZeneca) under fed conditions.   "
17981|NCT03050164|"     The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence     Study. During each session, the subjects will be administered a single dose of 250mg     Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of     AstraZeneca) under fasting conditions.   "
17982|NCT03050151|"     To collect data on actual-use to assess technical performance and user injections of     dupilumab auto-injection device by patients with atopic dermatitis (AD).   "
17983|NCT03050138|"     The primary objective in this cross-sectional study is to assess the prevalence of     post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin     versus dabigatran). PTS will be assessed by the recently developed Patient Reported Villalta     (PRV) Score.      Secondary objectives: to assess in both treatment arms the        1. Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study          treatment.        2. Prevalence of PTS determined by the standard Villalta score.        3. Health related Quality of Life (HRQoL).   "
17984|NCT03050125|"     This pilot study will investigate the impact of sterile saline drops that are formulated at     hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of     symptomatic CL wearers.   "
17985|NCT03050112|"     Adults with a congenital heart disease, having undergone a surgical intervention or a re-do     surgery in adulthood, are a growing group of subjects in the general population. This     increase is explained by improved medical and surgical techniques, with a better survival     rate as outcome.      There is nowadays a growing interest in the quality of life of this group of subjects.     However, studies give contradictory results. This can be explained on one hand by the vast     majority of pathologies within this population, and on the other hand by the absence of a     cardio-specific tool for quality of life measurement.      The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life     based on the exploration of three domains: physical, emotional and social.      The aim of this study is:        -  to evaluate the quality of life of these patients, by using the MacNew questionnaire        -  to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up        -  to assess the mortality within this group of patients.   "
17986|NCT03050099|"     A multi-protein test using mass spectrometry (MS) for multiplexed protein quantitation is     being developed. This test and the accompanying decision-aid software will provide Transient     Ischemic Attack (TIA) results rapidly for a fraction of the price of neuroimaging. With     guidance provided by this test, Emergency Department (ED) physicians can manage medical     imaging questions such as the use of Computed Tomography Angiography (CTA) prior to ED     discharge and appropriate (timely) referral to stroke clinics for consultation and follow-up     care. The right patients will receive the right treatment, reduce unwarranted imaging risks     and costs, and reduce the burden of stroke.   "
17987|NCT03050086|"     An open label feasibility study using BPX-01 topical minocycline gel in papulopustular     rosacea.   "
17988|NCT03050073|"     A chinese study shows that chinese population eyes with a primary angle closure have a     greater choroidal thickness than normal eyes.The increase of choroidal thickness would be     associated to this primary angle closure.   "
17989|NCT03050060|"     This phase II trial studies how well image guided hypofractionated radiation therapy works     with nelfinavir mesylate and nivolumab in treating patients with melanoma, lung cancer, or     kidney cancer that has spread. Hypofractionated radiation therapy delivers higher doses of     radiation therapy over a shorter period of time and may kill more tumor cells and have fewer     side effects. Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with     the ability of tumor cells to grow and spread. Giving hypofractionated radiation therapy,     nelfinavir mesylate, and nivolumab may work better in treating patients with melanoma, lung,     or kidney cancer.   "
17990|NCT03050047|"     A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics,     Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with     Advanced Solid Tumors   "
17991|NCT03050034|"     The present study was planned to provide clinical data on the impact of acute and critically     ill patients in Internal Medicine Unit activity and economic data enabling to quantify the     relative cost of acute patients management during ordinary hospitalization. In these     critically ill complex patients the vital parameters continuous monitoring could help in     improving the quality of care. Therefore, the study will check how the wireless continuous     monitoring in acute selected patients is able to reduce major complications improving the     patient's outcome and the quality of care and reducing costs compared to traditional     monitoring performed at regular intervals by the nursing staff.   "
17992|NCT03050021|"     Delirium is characterized by changes in mental status, inattension, disorganized thinking,     and altered consciousness. Prevalence of delirium in critically ill patients has varied from     20~80% depending on the severity of illness. Despite its high prevalence, delirium is often     under-recognized by clinicians due to the difficulties in diagnosis and no interest. Delirium     is associated with increased mechanical ventilation days, hospital length of stay, and     mortality. The purpose of this study is to analyze the prevalence of delirium and risk     factors for delirium in critically ill surgical patients.   "
17993|NCT03050008|"     Despite the advantages already demonstrated by FLACS, these surgeries still require     ultrasonic devices for fragmentation of the lens. The ultrasonic energy used during     phacoemulsification may induce complications such as reduction of endothelial cells and     corneal edema. In this sense, it would be beneficial to develop surgical techniques that     eliminate the need for ultrasound. The group of surgeons of Alfredo Tranjan Ophthalmic     Center, recently developed a surgical technique of cataract that optimizes the use of the     laser, eliminating the need for ultrasound during the surgical procedure. Thus, the     crystalline fragmentation process does not involve ultrasound being performed by the laser     itself. It is expected that this procedure will reduce the complexity of cataract surgery,     and be safer in terms of potential corneal lesions. The present study intends to evaluate the     benefit and safety of FLACS without use of ultrasound (USFREE), compared to traditional     phacoemulsification surgery using ultrasound in patients with senile cataract. In this sense,     it is intended to primarily compare the volume of balanced saline solution (BSS) between     surgeries.   "
17994|NCT03049995|"     Background: Stress echocardiography (SE) has an established role in evidence-based     guidelines, but recently the breadth and variety of applications has extended well beyond     coronary artery disease (CAD). Purpose: To establish a prospective research study of SE     applications, in and beyond CAD, also considering a variety of signs in addition to regional     wall motion abnormalities. Methods: In a prospective, multicenter, international,     observational study design, > 100 certified high-volume SE labs will be networked with an     organized system of clinical, laboratory and imaging data collection at the time of physical     or pharmacological SE, with structured follow-up information. The study is endorsed by the     Italian Society of Echocardiography and organized in 10 subprojects focusing on: contractile     reserve for prediction of cardiac resynchronization or medical therapy response; stress     B-lines in heart failure; hypertrophic cardiomyopathy; heart failure with preserved ejection     fraction; mitral regurgitation after either transcatheter or surgical aortic valve     replacement; outdoor SE in extreme physiology; right ventricular contractile reserve in     repaired tetralogy of Fallot; suspected or initial pulmonary arterial hypertension; coronary     flow velocity, left ventricular elastance reserve and B-lines in known or suspected CAD;     identification of subclinical familial disease in phenotype-negative healthy relatives of     inherited disease (such as hypertrophic cardiomyopathy). Expected Results:To collect about     10,000 patients over a 5-year period (2016-2020), with sample sizes ranging from 5,000 for     known or suspected CAD to around 250 for hypertrophic cardiomyopathy or repaired Fallot. This     data base will allow to investigate technical questions such as feasibility and     reproducibility of various SE parameters and to assess their prognostic value in different     clinical scenarios. Conclusions: The study will create the cultural, informatic and     scientific infrastructure connecting high-volume, accredited SE labs, to obtain original     safety, feasibility, and outcome data in evidence-poor diagnostic fields, also outside the     established core application of SE in CAD based on regional wall motion abnormalities. The     study will standardize procedures, validate emerging signs, and integrate the new information     with established knowledge, helping to build a next-generation SE lab without inner walls.   "
17995|NCT03049982|"     The purpose of the study is to test the workflow of an auto-titrating mandibular positioner     in its intended setting. Participants with obstructive sleep apnea will use the device to     determine their eligibility for oral appliance therapy and provide feedback on usability of     the device.   "
17996|NCT03049969|"     The proposed study will test the feasibility and tolerability of transcranial direct current     stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 20 cognitive     remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to     2.0 mA, dorsolateral prefrontal cortex or DLPFC montage) while they complete the cognitive     training tasks.   "
17997|NCT03049956|"     Myasthenia gravis is an autoimmune disorder of neuromuscular transmission, characterized by     fluctuating muscle weakness and fatigability. In isolated ocular myasthenia, when only the     extraocular muscles are involved, most common ancillary tests, such as acetylcholine receptor     autoantibodies and repetitive nerve stimulation, are often negative.      A simple, quick and non-invasive test for ocular myasthenia based on ocular vestibular evoked     myogenic potentials (oVEMP) was recently developed.      The main goal of the study is to validate repetitive oVEMP stimulation in a blinded     diagnostic accuracy study in order to facilitate early and accurate diagnosis of ocular     myasthenia.   "
17998|NCT03049943|"     The aim of this study was to compare the effects of different wave lengths of LLLT on     salivation in participants suffering from hyposalivation.      This study included 30 participants whose major salivary glands were treated with low     intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10     consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and     treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and     stimulated saliva was measured each day during 10 days, before and after laser treatment and     10th day after treatment was ended.   "
17999|NCT03049930|"     The purpose of this study is to determine whether a low-dose ketamine infusion can be used as     the main intra-operative analgesic in different burn patients, and thereby reduce the total     intra-operative opioid requirement. Secondary objectives are to determine whether this     low-dose ketamine infusion will lengthen the amount of time to the first narcotic given in     the recovery room or ICU, and whether pain scores for awake patients will be lower     post-operatively.   "
18000|NCT03049917|"     The purpose of this study is to determine whether giving small financial incentives will     motivate parents to test their children for HIV.   "
18617|NCT03041883|"     The purpose of this study is to demonstrate the safety and efficacy of the corneal collagen     crosslinking with riboflavin and ultraviolet A in aim to increase the resistance of the graft     used as a support for the Boston keratoprosthesis (KPro) type I against corneal melting     (keratolysis or sterile necrosis).   "
18001|NCT03049904|"     This is a pilot study of the feasibility of the virtually reality, online, culturally     grounded HIV prevention intervention for Native American men who have sex with men. The     project will include 90 Native American men who have sex with men (MSM) from across the     continental United States as well as Alaska and Hawaii.      The investigators will use a randomized clinical trial with a waitlist control condition to     evaluate the intervention's impact on HIV / Sexually Transmitted Infections (STI) testing     behavior, condom use, and substance use harm reduction. Specifically, investigators will ask     participants to spend 3 weeks exploring a virtual reality environment hosted in the Second     Life® platform. The island consists of 3 levels: Learning Level, Skills building level, and     Experiential level.      In the Learning level the participant's avatar will have the opportunity to attend up to 2     free Motivational Interviewing sessions to establish their goals for their time on the     island. Additionally, they will explore 4 learning paths each covering a knowledge objective:     HIV Testing, Condom Use & Condom Use Negotiation, Safer Sex, and Harm Reduction. Each path     will present knowledge via videos, interactive games, stories, and teachings. After     completing level 1, participants will move on to the Skills building level. Here participants     will have the opportunity to role play scenarios (e.g., obtaining an HIV test, requesting     PrEP from their doctor, negotiating condom use) with pre-program virtual actors. All     scenarios are based on the knowledge gained in the Learning Level. Participants will also     engage on mini-quests for additional knowledge and in-world rewards. Finally, in the third     level participants will be able to practice the skills learned in interactions with other     participants' avatars.      If efficacious, this online HIV prevention intervention has the potential for widespread     dissemination and could be particularly helpful for rural and reservation-based Native MSM     who often have difficulty accessing services and support.   "
18002|NCT03049891|"     The decentralization study will describe children taking antiretroviral therapy (ART) at a     larger health facility in the Eastern Cape province of South Africa, between the years of     2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). The study will measure     how many children stay in care and how many die, as well as their health status. The study     will also compare whether children do better if they stay in care a large hospitals or if     they get health care at smaller clinics. A second part of the study will find children in the     community who have stopped coming for health care and find out what happened to them and what     their health status is.   "
18003|NCT03049878|"     Objectives:      The aim of this study was to determine the effectiveness of preoperative administration of     single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the     surgical removal of an impacted mandibular third molar.      Materials and Methods:      The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral     symmetrical impacted mandibles. Patients were randomized in two experimental groups to     receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo     (placebo group) at the first and second surgeries. Study participants were asked to record     pain intensity scores during the operation and the next 2 days, the time of the first request     for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine     tablets.   "
18004|NCT03049865|"     The principal aim is to assess if a simple test, the time it takes to walk 10 meters for a     patient about to be discharged after a hospital stay for an acute illness, is related to the     risk of readmission.   "
18005|NCT03049852|"     1. CBT-001 administered three times daily (TID) for 4 weeks has an acceptable safety          profile when used in pterygium patients        2. CBT-001 administered TID for 4 weeks is more effective than the vehicle in reducing          pterygium vascularity and inhibiting pterygium lesion growth        3. CBT-001 administered as topical ocular dosing displays negligible systemic drug exposure   "
18006|NCT03049839|"     The main aim of this study is to evaluate the feasibility and effectiveness of a program for     modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk factors     in adults with different categories of risk from the primary health care strategy.      The project will show the effect of these interventions for the first time in people With     different risk of developing type 2 diabetes throughout the life in populations living in     Colombia Located in 2 different cities, one of them in the interior of the country (districts     of Bogota) and another in the north coast (districts of Barranquilla) .   "
18007|NCT03049826|"     Background: There are few studies about nutrition to children and adolescents with cancer,     and in particular during stem cell transplantation (SCT). Studies from other countries     suggest that malnutrition is common on admission; the situation decline during treatment and     may persist for a long time.      Aim: This project aims to improve the nutritional therapy to children being treated for     cancer and children undergoing stem cell transplantation   "
18008|NCT03049813|"     This is a randomized controlled trial to evaluate the community-based effectiveness of     virtual reality job interview training (VR-JIT). Northwestern University is partnering with     Thresholds Inc. to evaluate the effectiveness of VR-JIT at improving interviewing skills and     access to employment. In addition, we will evaluate the cost effectiveness of VR-JIT and the     process for implementing VR-JIT at Thresholds.   "
18009|NCT03049800|"     The purpose of this study is to perform longitudinal high-resolution 7T MRI in participants     with first-episode psychosis (FEP) enrolled in our ongoing randomized controlled clinical     trial (RCT) of cognitive training. The investigators seek to determine whether a 12-week     course of intensive cognitive training of auditory processing in young FEP patients delivered     remotely as a stand-alone treatment is neuroprotective against neural tissue loss in auditory     cortex (superior temporal gyrus, STG), and possibly in other cortical regions. The     investigators will also observe the effects of training on white matter integrity in the     brain.   "
18010|NCT03049787|"     This study aims to evaluate physical therapy (standard of care) and home exercise vs. home     exercise alone for the treatment of adhesive capsulitis.   "
18011|NCT03049774|"     The aim of this retrospective study is to review and describe the safety and the efficacy of     recombinant human interleukin-11 (I) i (Baijieyi), using information already recorded in 20     medical records, The time periods include May 8th of 2008 to december 31st of 2016.   "
18012|NCT03049761|"     Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different     Pressure Settings   "
18013|NCT03049748|"     The purpose of this study is to evaluate the use of VAD Care App in an out-patient mechanical     circulatory support program. The specific aim for this pilot study is to obtain preliminary     efficacy data of the VAD Care App as a self-management tool for patients with long-term     LVADs. A randomized control trial will be employed to establish preliminary estimates of the     effects of the App on the following outcomes: (1) patients' and caregivers' self-efficacy and     (2) adherence to the LVAD care regimen; (3) LVAD-related complications and health care     utilization [e.g., hospital re-admission]; and (4) the patients' overall health status and     (5) quality of life. The duration of the study is 6 months.   "
18015|NCT03049722|"     The purpose of this study is to collect clinical data for the development and evaluation of a     new device feature for automatic AV-delay (AVD) optimization.   "
18016|NCT03049709|"     There is growing evidence that central blood pressure is a better predictor of hypertensive     end-organ damage and cardiovascular outcome than routine brachial readings.      The investigators aimed to evaluate the accuracy of a novel device for the non-invasive     determination of central blood pressure based on automated oscillometric radial pulse wave     analysis.   "
18031|NCT03049514|"     Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at the     retinal level. They share the same risk factors and common pathology. Their incidence is     lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual     acuity (VA) <1/10. The diagnosis of an CRAO is clinically based on the sudden occurrence of a     decrease in deep visual acuity with fundamentally signs of reactive ischemia. There is no     data on early retinal arterial recanalization after CRAO, nor on the relationship between     early recanalization (spontaneous or post-thrombolysis) and visual prognosis.   "
21907|NCT02998853|"     Reliability of 3D angio QFR functional evaluation of all non culprit lesions >50% in STEMI     patients during first acute procedure   "
18017|NCT03049696|"     The primary objective of the study is to determine whether participation in a pre-bariatric     surgery physical activity and behavior modification/education program (ENCOURAGEING START)     that is tailored to the unique needs of obese bariatric surgery patients, improves physical     fitness, surgical outcomes, patient health and quality of life. Short- (one year) and long-     (five year) term outcomes will be compared to matched historical controls (1:1) based on age,     gender, and body mass index (BMI) from the existing Manitoba Centre for Metabolic and     Bariatric Surgery (CMBS) database. Our findings will determine whether a pre-bariatric     surgery physical activity and behavior modification/education program results in improve     surgical and patient outcomes and inform the development of evidence-based physical activity     (PA) guidelines for bariatric surgery patients and improved CMBS program delivery.   "
18018|NCT03049683|"     To lower the threshold for clinical application by reducing the testing time for recording     vestibular-evoked myogenic potentials (VEMPs), we evaluated whether a simultaneous recording     of ocular and cervical VEMPs after unilateral or bilateral stimulation can be achieved     without a loss in diagnostic sensitivity.   "
18019|NCT03049670|"     Klorsept is a debridement solution of necrotic infected tissue promoting wound healing. The     aim of this study is to elaborate the effectiveness and safety of this solution.   "
18020|NCT03049657|"     Clinical trial with an European Community marked medical device in patients with ischemic     heart disease and clinical indication of coronary revascularization with drug-eluting stent.      Clinical follow-up will be done according to this way: first month telephone or face-to-face     interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)      A randomized clinical trial to compare the efficacy of Angiolite Stent versus a     second-generation drug-eluting stent such as Xience stent.(non-inferiority design)   "
18021|NCT03049644|"     Mechanical diagnosis and treatment (MDT) and Manual Therapy (MT) have both demonstrated     efficacy in the management of CLBP. The use of a Point of Care (POC) design in this study     will allow for comparison of these two treatment modalities in a clinical setting. The     purpose of this study is to demonstrate the feasibility of recruiting, enrolling and     collecting outcome data on CLBP patients utilizing the POC methodology.   "
18022|NCT03049631|"     The primary objective aims are to assess the effects of regular consumption of red     raspberries (RRB) with and without fructooligosaccharide (FOS) on the composition of the gut     microbiota after 4 week intake and in parallel characterize plasma and urine metabolite     profiles examining qualitative and quantitative intervention associated changes.   "
18023|NCT03049618|"     This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab     work in treating patients with non-small cell lung cancer that has spread to other places in     the body or head and neck squamous cell cancer that has come back or spread to other places     in the body. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving     recombinant EphB4-HSA fusion protein and pembrolizumab may work better in treating patients     with non-small cell lung or head and neck squamous cell cancer.   "
18024|NCT03049605|"     This study are to:        -  Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.        -  Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.        -  Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy          in diabetic patients.   "
18025|NCT03049592|"     High-risk obstetrical patient Intervention to promote Birth Interval Spacing utilizing the     Contraceptive CHOICE project script to reduce Unintended Subsequent pregnancies (HIBISCUS) is     a collaborative study utilizing qualitative methods to assess the acceptability including a     family planning specialist's postpartum contraception counseling during and after prenatal     care among Latina obstetric women with pre-gestational diabetes. The investigators will     compare the effectiveness of HIBISCUS versus usual contraceptive counseling on Long-Acting     Reversible Contraception (LARC) use at 3 months postpartum.   "
18026|NCT03049579|"     The purpose of this study is to investigate the effects of a probiotic supplementation on     adult volunteers with having caught the common cold more than 4 times in the past year. This     study is a single center, double-blind, randomized, controlled, parallel-designed,     prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus     paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and     Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a     12-week study period.      The incidence of flue and cold during the study period were compared between study groups.      Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal     samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was     drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin     A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.   "
18027|NCT03049566|"     This study aims to assess independent factors associated with the clinical decision to     discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.   "
20592|NCT03016013|"     The purpose of this study is to initially access the safety and effectivity of RC18 combined     with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with     moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.   "
18030|NCT03049527|"     The objective of this research project is to investigate specific behaviors and exposures     related to sugarcane work and their association with non-communicable diseases, specifically     Chronic Kidney Disease of Unknown Origin (CKDu) among sugarcane workers in Guatemala. Over     the course of the 6-month sugarcane harvest the investigators will assess risk factors for     declining kidney function, and also changes in biomarkers of kidney function pre and post     work shift of field and factory workers and their possible relationships with dehydration and     heat stress. The investigators will also evaluate the effectiveness of an intervention aimed     at increasing hydration and reducing heat stress. Finally the investigators will measure     biomarkers of exposure and environmental samples for heavy metals, agrochemicals, and     infectious disease (Leptospira).   "
19136|NCT03035071|"     The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic     gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the     minimally invasive approach with the standard open procedure regarding morbidity and     mortality.   "
18032|NCT03049501|"     The prevalence of family caregivers is projected to increase in concert with the projected     increase in number of AD patients. The focus of the study is to gather systematic data on the     acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social     intervention program that targets ethnically/culturally diverse family caregivers of patients     with Alzheimer's Disease. The overall goal of the project is to improve the lives of family     caregivers as well as their ability to provide care to their loved one and to reduce     disparities in access to needed services and support among caregiver populations.   "
18033|NCT03049488|"     Background:      RSV is a virus that infects the lungs and breathing passages. Healthy adults who are infected     generally have mild cold symptoms for a week or two. But it can also be serious, especially     for infants and older adults. It can be spread by direct or indirect contact with respiratory     secretions. Researchers want to study a new vaccine to prevent RSV.      Objective:      To see if a vaccine for RSV is safe and if it causes side effects.      Eligibility:      Healthy adults 18-50 years old      Design:      Participants will be screened in a different protocol.      Participants will have 13 visits over 1 year.      Some participants will receive just vaccine. Some will receive vaccine mixed with alum, which     could make the body respond to the vaccine better.      All will receive their dose by injection in the upper arm. They will receive two doses, one     at the beginning of the study and another 12 weeks later.      Participants will be watched for 1 hour after injection. They will be called 1 day after.      They will keep track of their temperature and side effects for 7 days after.      Participants will receive a ruler to measure any changes on their skin at the injection site.      At all visits, participants will be checked for health changes or problems. They may have     blood drawn.      At some visits, participants will have samples taken from their nose and mouth.   "
18034|NCT03049475|"     Background:      Sickle Cell Disease (SCD) is a blood disorder that occurs mainly in people of African     descent. Researchers want to learn more about the painful attacks and complications     associated with SCD. They want to look for a relationship between SCD and specific changes in     the blood. They want to study the role of genetics, inflammation, and blood clotting factors     in SCD. They will do this with blood samples collected during an acute painful attack and in     between attacks.      Objective:      To learn more about the painful attacks and complications associated with SCD.      Eligibility:      People ages 18-80 with SCD or who are healthy Africans or African Americans without SCD      Design:        -  Participants will be screened with medical history and physical exam.        -  Healthy participants will have one visit.        -  Participants with SCD will have their first visit when they are not having a pain          attack. They will have their next visit during a pain attack. About 3-4 months after          this attack, they will have a final visit.        -  Visits will include a physical exam, and blood and urine tests.        -  Participants may have their blood samples used for genetic testing for research.   "
18035|NCT03049462|"     Background:      Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve     insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body     burn energy.      Objective:      To learn more about how BAT works to burn energy.      Eligibility:      Healthy people ages 18-40 with a body mass index between 18 and 40      Design:      Participants will be screened with:      Medical history      Physical exam      Blood, urine, and heart tests      Dietitian interview      Participants will have an overnight baseline visit. This includes:      Repeats of screening tests      Exercise test      Scans. For one scan, a radioactive substance is injected into the arm.      FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are     injected in one arm. Blood glucose and insulin levels are measured from the other.      Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate.     Monitors on the body measure heart rate, movement, and temperature.      Optional fat biopsy: A small piece of tissue is removed with a needle.      Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron.     Men will be randomly get either the drug or a placebo.      All participants will have a visit after 2 weeks of the pills. They will repeat the screening     tests.      Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests.      Participants will keep food and medication diaries.      Participants will have a follow-up visit 2 weeks after stopping the pills. This includes     heart tests.   "
18036|NCT03049449|"     Background:        -  Improved treatments for a variety of treatment-resistant, CD30-expressing malignancies          including Hodgkin lymphoma, anaplastic large cell lymphoma, and other CD30- expressing          lymphomas are needed.        -  T cells can be genetically modified to express chimeric antigen receptors (CARs) that          specifically target malignancy-associated antigens.        -  Autologous T cells genetically modified to express CARs targeting the B-cell antigen          CD19 have caused complete remissions in a small number of patients with lymphoma. These          results demonstrate that CAR-expressing T cells can have anti-lymphoma activity in          humans.        -  CD30 expression can be easily detected by immunohistochemistry on lymphoma cells, which          allows selection of CD30-expressing malignancies for treatment.        -  CD30 is not known to be expressed by normal cells except for a small number of activated          lymphocytes and decidual cells in the pregnant uterus.        -  We have constructed a novel fully-human anti-CD30 CAR that can specifically recognize          CD30-expressing target cells in vitro and eradicate CD30-expressing tumors in mice.        -  This particular CAR has not been tested before in humans.        -  Possible toxicities include cytokine-associated toxicities such as fever, hypotension,          and neurological toxicities. Elimination of a small number of normal activated          lymphocytes is possible, and unknown toxicities are also possible.      Objectives:      Primary      -Determine the safety and feasibility of administering T-cells expressing a novel fullyhuman     anti-CD30 CAR to patients with advanced CD30-expresssing lymphomas.      Eligibility:        -  Patients must have Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell          lymphoma not otherwise specified, diffuse large B-cell lymphoma not otherwise specified,          primary mediastinal B-cell lymphoma, grey zone lymphoma, enteropathyassociated T-cell          lymphoma, or extranodal NK/T-cell lymphoma, nasal type        -  Patients must have malignancy that is both measurable on a CT scan with a largest          diameter of at least 1.5 cm and possessing increased metabolic activity detectable by          PET scan. Alternatively patients with lymphoma detected by flow cytometry of bone marrow      are eligible.        -  Patients must have a creatinine of 1.4 mg/dL or less and a normal cardiac ejection          fraction.        -  An ECOG performance status of 0-1 is required.        -  No active infections are allowed including any history of HIV, hepatitis B, or hepatitis          C. Patients must be seronegative for CMV by blood PCR.        -  Absolute neutrophil count greater than or equal to 1000/micro L, platelet count greater          than or equal to 45,000/micro L, hemoglobin greater than or equal to 8g/dL        -  Serum ALT and AST less or equal to 3 times the upper limit of the institutional normal          unless liver involvement by malignancy is demonstrated.        -  At least 14 days must elapse between the time of any prior systemic treatment (including          corticosteroids) and initiation of protocol enrollment.        -  Clear CD30 expression must be detected on 75% or more of malignant cells from either          bone marrow or lymphoma mass by flow cytometry or immunohistochemistry. The patient s          malignancy will need to be assessed for CD30 expression by flow cytometry or          immunohistochemistry performed at the NIH. If unstained, paraffin-embedded bone marrow          or lymphoma sections are available from prior biopsies, these can be used to determine          CD30 expression by immunohistochemistry; otherwise, patients will need to come to the          NIH for a biopsy to determine CD30 expression. The sample for CD30 expression can come          from a biopsy obtained at any time before enrollment, unless the patient has received a          prior anti-CD30 monoclonal antibody, in which case the sample must come from a biopsy          following completion of the most recent anti-CD30 monoclonal antibody treatment.        -  Eligible patients with Hodgkin lymphoma must fulfill one of the following criteria: 1)          have received two prior therapies, one of which must be an autologous stem cell          transplant, or 2) have received three prior lines of therapy. Eligible patients with any          of the listed peripheral T cell lymphomas or non-Hodgkin lymphomas must have received          two lines of prior therapy, at least one of which must contain cytotoxic      chemotherapyPatients with diffuse large B-cell lymphoma or primary mediastinal B-cell     lymphoma must have received 2 prior treatment regimens at least 1 of which included an     anthracycline and an anti-CD20 monoclonal antibody.        -  Patients who have never had an allogeneic hematopoietic stem cell transplant as well as          patients who have had an HLA-matched sibling or a 8/8 HLA-matched unrelated donor          hematopoietic stem cell transplant are potentially eligible.        -  Women who are pregnant or plan to become pregnant will be excluded. Due to the risk of          damage to normal uterine tissue during the secretory phase of menstruation, w......   "
18047|NCT03049306|"     The primary objective in this study is to test whether propranolol lowers glucose and free     fatty acid levels during sleep in obstructive sleep apnea (OSA), and preserves vascular     function (EndoPAT) versus placebo. The secondary objective is to test whether propranolol     influences sleep quality, architecture, and hemodynamics in OSA. OSA will be elicited by     temporarily discontinuing CPAP therapy in patients with a history OSA accustomed to CPAP     therapy (CPAP withdrawal).   "
18048|NCT03049293|"     To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and     morpho-genetics.      The reason to measure Midazolam levels in larger size follicles in this study is to maximize     the chances to get a mature oocyte and therefore develop into a potential embryo to be     analyzed.   "
18037|NCT03049436|"     Physical activity has demonstrated efficacy in cancer prevention and improves quality of life     and outcome in cancer survivors. Patients undergoing chemotherapy, especially those with     advanced disease, may have symptoms leading to inactivity. Adapted physical activity (APA)     among those patients could improve their tolerance to the treatment, and thereby their     quality of life. APA could be beneficial to patients with curable disease as well as patients     undergoing palliative chemotherapy. Some studies suggest that fighting against loss of muscle     mass could lead to a survival benefit. However, APA is not established in daily practice and     has not yet been evaluated in a chemotherapy ambulatory care unit.      Primary aim of the study is to assess feasibility of an APA program in a chemotherapy     ambulatory care unit of digestive, lung, hematological and dermatological cancers Secondary     aim is to measure the impact of an APA program on fatigue, anxiety, depression and handgrip     strength in patients beginning chemotherapy or targeted therapy for a digestive, lung,     hematological or dermatological cancer, of any stage.   "
18038|NCT03049423|"     To compare the results of multi-position MRI scans for ankle ligaments and tendons to clarify     how to obtain imaging data of different ankle ligaments and define severity of injuries to     calculate the rate of correct diagnosis, thereby developing a reasonable surgical treatment     in clinical practice.   "
18039|NCT03049410|"     This is a prospective multicentre randomised controlled trial comparing the outcomes from     Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder     cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or     muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment     of bladder cancer. The time of interest for measurement of the primary outcomes will be 90     days post-surgery.      Eligible patients will include those receiving neo-adjuvant chemotherapy (typically     gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder     reconstruction.      Patients who have selected radical cystectomy after appropriate counselling and following a     specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to     consent for this study.      Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be     followed for a minimum of 90 days post-surgery.      The study will be conducted in NHS Trusts designated as Cancer Centres. Patients will be     stratified by        -  Type of urinary diversion (Continent diversion or ileal conduit)        -  Performance status        -  Centre Trial assessments will be conducted at baseline (before surgery), whilst          participants are on admission and then 5, 12, 24 weeks and 1 year post surgery.   "
18040|NCT03049397|"     This pilot clinical trial studies how well the Enhancing Connections program improves family     adjustment in patients with incurable cancer. Participating in an educational program with a     co-parent to learn about ways to talk to a child about cancer may help parents and co-parents     support their child with the parent's cancer and may help families communicate and function     better.   "
18041|NCT03049384|"     Fatigue is a common and distressing symptom in cancer survivors. Cancer-related fatigue is     relieved with physical activity but the mechanisms for this are not well understood. The     investigators hypothesize that a tailored and individualized exercise intervention will     reduce cancer-related fatigue more than a classical exercise intervention. This study is     designed to investigate the causes of fatigue with whole-body exercise and their relation to     self-reported measures of fatigue before and after an exercise intervention.   "
18042|NCT03049371|"     The current study will explore behavioral, surgical and biological neovaginal and rectal HIV     transmission risks and feasibility of collection of blood and ano-genital samples (rectal,     genital and neo-vaginal, including urine) for microbiological, immunological and cytological     characterization in the context of antiretroviral chemoprophylaxis for the prevention of HIV     infection in TGW. This includes the feasibility of home self-collection of ano-genital     samples prior to habitual cleansing of the anatomical collection site.   "
18043|NCT03049358|"     This randomized phase I trial studies how well olfactory training works in improving sense of     smell after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer.     Olfactory training may improve smell function after radiation therapy in patients with     paranasal sinus or nasopharyngeal cancer.   "
18044|NCT03049345|"     Gastric cancer has an incidence in North America of over 24,000 new cases annually, of which     approximately 15% are diagnosed at an early stage. Standard of care for early gastric cancer     (EGC) treatment has historically included anatomical resection with regional lymphadenectomy.     However, with the recent emergence of organ-sparing techniques, select patients with a very     low risk of lymph node metastases are able to avoid anatomical resection and its inherent     short and long term consequences. Despite this advance, EGC patients with high risk features     continue to require anatomical resection to achieve adequate lymph node staging, despite the     fact that 75-95% of these patients ultimately are found to have node negative disease. Due to     the inadequacy of standard imaging modalities to reliably detect nodal metastases in EGC     patients, sentinel lymph node sampling for gastric cancer was developed using principals     similar to those used broadly for breast and melanoma patients. Early reports from Asia     suggest this technique has very high success rates, accuracy and sensitivity, however it has     never been verified in a North American context. This study aims to test SLN sampling for     North American gastric cancer patients at a high volume regional treatment centre, with an     aim to expand the application of organ sparing resection to EGC patients.      This project aims to determine the sensitivity and accuracy of sentinel lymph node sampling     for early gastric cancer patients at a high volume, North American, tertiary care centre.   "
18045|NCT03049332|"     This project is to develop a culturally sensitive and feasible self- and family-management     intervention that will assist HIV+ Chinese women and their families to manage the illness and     improve quality of life and clinical outcomes.   "
18046|NCT03049319|"     Psoriasis affects 2-3% of the American population. While a wide variety of therapies     currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant     and retinoid agents a better understanding of phototherapy is needed. Given the prevalence of     localized psoriasis and dissatisfaction with treatment, investigation of localized treatment     should be a priority for researchers with goals to improve the current standard of care.   "
18081|NCT03048851|"     Immediate and maintaining Efficacy of new protocols in the treatment of upper limb     dysfunctions in patients with cerebral palsy.   "
18049|NCT03049267|"     Study design: A double-blind randomised placebo-controlled trial      Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen     patients will be randomized to apremilast and five patients to placebo. The total duration of     the treatment period per subject is 16 weeks.      Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS     lesional skin at week four (t=4) and week sixteen (t=16):        -  of patients receiving apremilast compared to placebo;        -  within both groups relative to baseline (t=0).      Secondary objectives:        -  To prospectively evaluate the clinical efficacy of apremilast.        -  To assess the effect of apremilast on patient reported outcomes measures.        -  To assess the short-term safety and tolerability of apremilast in patients with          hidradenitis suppurativa.   "
18111|NCT03048461|"     The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP)     in the treatment of androgenetic alopecia.      This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma     in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized     into the study. The study is designed as an 18-month study consisting of 2 phases. This study     was a pilot study designed to determine feasibility of this procedure.      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion     criteria will be considered for enrollment.   "
18050|NCT03049254|"     Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the     heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or     death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very     difficult as the disease process can be subtle, but sufficient enough, so that the first     event is sudden death.      The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and     Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to     enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from     the US and UK. Family members who are blood-relatives will also be invited, including those     who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI,     Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples.      Objectives of the study:        1. Discover new genes or altered genes (variants) which cause AVC        2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and          the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation)        3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally          using clinical, electrocardiographic and imaging data.        4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with          gold-standard endomyocardial biopsies   "
18051|NCT03049241|"     Potential factors involved in neuromuscular fatigue were classified into two categories: 1)     central factors involving the central nervous system and neural pathways, and 2) peripheral     factors occurring within the muscle beyond the neuromuscular junction. In adults, it has been     shown that peripheral factors contribute to a large part of the fatigue induced by repeated     maximal contractions. However in children, central factors could account for the development     of fatigue to a greater extent. Force-generating capacity and musculotendinous stiffness     could be two of the discriminatory factors accounting for the differences in the     neuromuscular fatigue between children and adults.      Force production capacity and musculotendinous stiffness vary as function of muscle length.     Naturally, they could differ depending on the muscle groups studied. The main aim of the     present protocol is to compare the effect of knee extensors and ankle plantarflexors length     on the development and aetiology of neuromuscular fatigue, in children and adults. The     investigators formulated the hypotheses that at short muscle length force and low     musculotendinous stiffness, differences in force between children and adults would be     reduced. Thus neuromuscular fatigue development and aetiology would be similar between both     groups. The results of the present protocol will allow to better understanding of the     aetiology of neuromuscular fatigue in children and help improving training or rehabilitation     programs.   "
18052|NCT03049228|"     It has been suggested that mitochondrial dysfunction might play a role in the development of     diabetic cardiomyopathy. From animal studies, it has been suggested that an altered PPAR and     PGC1 expression is involved in the reduced cardiac mitochondrial function, however human data     on cardiac mitochondrial function and PPAR regulation is scarce. The latter is due to the     fact that there is no validated measurement for assessing cardiac mitochondrial function     non-invasively in vivo. It has been suggested that measuring PCr/ATP ratio with 31P-MRS in     the heart reflects cardiac mitochondrial function. However, so far no direct validation of     this method has been performed. The aim of this study will be to validate in vivo 31P-MRS     with ex vivo measurements of mitochondrial function. To this end, the hypothesis is that in     vivo 31P-MRS is a valid method for measuring cardiac mitochondrial function when compared     with ex vivo mitochondrial respirometry.   "
18053|NCT03049215|"     The study hypothesis is that placement of LAMS plus an overlapping double pigtail stent for     endoscopic transmural drainage of PFCs with solid debris will result in improved drainage and     require fewer endoscopic interventions compared to placement of LAMS alone.   "
18054|NCT03049202|"     Obstructive lung disease is an increasing global health problem of pandemic proportions, with     COPD alone affecting >10% of the population. Smoking is the main and most well studies risk     factor for developing COPD. However, chronic airway obstruction also in never-smoking     populations has recently been recognized as an increasing health problem.      In the clinical segment (PI: Prof. C. Magnus Skold), 1000 subjects from the Swedish national     SCAPIS study will be clinically well characterized in one of the six Swedish University     Hospital Respiratory clinics (clinical site PIs: Anders Andersson, Leif Bjermer, Anders     Blomberg, Christer Janson, Lennart Persson, Magnus Skold). This first screening includes all     never-smokers with COPD identified in the SCAPIS study. A subset of 300 subjects from the     groups of Healthy never-smokers, current-smokers with normal lung function, current-smokers     with COPD, ex-smokers with COPD, and never-smokers with COPD will be selected for the     Bronchoscopy segment, were sampling will be performed from a number of anatomical locations,     including bronchial biopsies, airway epithelial brushings, and bronchoalveolar lavage. Serum,     plasma, and urine samples will also be collected.      In the systems medicine segment (PI: Assoc. prof Asa M. Wheelock), alterations at the     epigenetic, mRNA, microRNA, proteome, metabolome and microbiome level will be performed from     multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and     bronchoalveolar exudates). By means of biostatistics and bioinformatics approaches, specific     mediators and molecular pathways critical in the pathological mechanisms of obstructive lung     disease related to never-smoker disease phenotypes will be identified.      In the immunohistochemistry segment (PI: Prof. Jonas Erjefalt), a number of molecules of     relevance for disease pathology will be investigated in bronchial biopsies collected from the     300 subjects in the Bronchoscopy segment.   "
18055|NCT03049189|"     The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide     Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus     in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+),     neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).   "
18056|NCT03049176|"     This is a prospective, non-randomized, open-label study to look at the uptake, adherence to,     and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing,     and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in     Zimbabwe.   "
18057|NCT03049163|"     Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar     anesthesia. However, both methods have potential complications that can vary from minor to     severe.      Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other     vitreoretinal surgeries.      Hence, the investigators compared the effect of topical anesthesia (with eye drops) and     retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.   "
18058|NCT03049150|"     To determine whether MALDI, a type of Mass-Spectometry, can use protein pattern detection     within urine to predict postoperative (after an operation) kidney damage in adults who have     undergone emergency hip fracture surgery?   "
18059|NCT03049137|"     Using bone ring grafts with simultaneous implant placement after three-dimensional     augmentation of severely defective bone ridges using computer-guided surgical templates. The     study compares accuracy effectiveness by mimics software   "
18060|NCT03049124|"     Currently, there is no clear indication if exercise is safe and if it confers health benefits     for adults undergoing preoperative neoadjuvant chemoradiation for rectal cancer - a     population who may have limited exercise tolerance and who may be at an increased risk for     adverse events associated with exercise. In this prospective single-arm feasibility trial, we     aim to examine the safety and feasibility of a 12-week exercise intervention for adults     undergoing preoperative neoadjuvant chemoradiation for rectal cancer to inform the     development of a large-scale randomized controlled trial that will assess the efficacy of     exercise administered during preoperative neoadjuvant chemoradiation for rectal cancer.     Adults diagnosed with rectal cancer and scheduled for preoperative neoadjuvant chemoradiation     will be recruited over a 12-month period into a supervised exercise intervention consisting     of aerobic and strength training to be done 3 times per week. Feasibility, safety,     patient-reported outcomes, and physical tests will be performed pre-intervention,     post-intervention, and at follow-up (i.e., 6 weeks post-intervention). This study will     provide data on the feasibility of an exercise intervention and will help determine if it is     safe to progress with a large-scale randomized controlled trial to test the benefits of     exercise for adults undergoing preoperative neoadjuvant chemoradiation for rectal cancer. It     will also provide initial estimates of the parameters for patient-reported outcomes, which     are required to calculate the sample size for the large-scale randomized controlled trial to     ensure it is sufficiently powered.   "
18061|NCT03049111|"     This study is designed to identify Dermatophagoides farinae, or Der f, sensitive asthmatics     who demonstrate a late phase asthmatic response after Der f inhalation. These subjects may be     invited to participate in a planned future study investigating novel asthma treatments.   "
18062|NCT03049098|"     The aim of this observational study is to compare the visual interests between residents in     high-fidelity simulation practice   "
18063|NCT03049085|"     Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass     Grafting. A double-blind, placebo-controlled, randomized trial.   "
18064|NCT03049072|"     The purpose of the study is the prospective and standardized data collection of patients     treated with ion therapy at MedAustron.   "
18065|NCT03049059|"     A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without     Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma   "
18066|NCT03049046|"     Approximately 21 subjects with amyotrophic lateral sclerosis (ALS) will be randomized (6 to     1) to receive by mouth seven morning doses of CC100 or placebo for 7 days. Subjects are     required to stay in the Clinic for approximately 9 hours following the first and last dose.     Subjects will also have a mid-week clinic visit and will be contacted by phone within 3 to 5     days after the last dose.      Funding Source - FDA OOPD   "
18067|NCT03049033|"     Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow     movements, small movements, difficulty with movement initiation and disruptions in timing.     Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday     tasks such as writing, self-care, and fine object manipulation. These activity limitations     can lead to disability, social isolation, and a reduced quality of life. In a series of     breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT)     and found it can address many gross motor impairments and improve gait and balance. The     underlying idea is that rhythm is the essential component relating music specifically to     motor behavior. The mechanism of action is called rhythmic entrainment where one system's     motion or signal frequency entrains the frequency of another system. The effect of NMT on     fine motor function has not been investigated yet. Music activities are important in the     lives of many older adults. Notably, the use of music has been associated with increased     well-being for older adults, as it fosters social connection and mood regulation.     Furthermore, many musical activities have limited physical demands, making them attainable     for individuals who are living with mobility impairments or other physical restrictions.     Based on the literature and the investigators preliminary studies, the investigators propose     to test the efficacy of Neurologic Music Therapy in comparison to Occupational Therapy (OT)     as standards of care on adults in the Parkinson's spectrum. The investigators have defined a     working plan using different musical instruments and growing tempo to specifically improve     fine motor movements.   "
18068|NCT03049020|"     Based on a prospective study, to evaluate how pre-operative pelvic floor status - the     presence of injury to the musculus levator ani - may influence the results of laparoscopic     sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the     presence of such injury increases the risk of post-operative prolapse recurrence   "
18110|NCT03048474|"     This is a prospective, monocenter, single arm, phase II trial in 33 patients with     unresectable MPM, who experience disease progression or recurrence after at least one     previous line of platinum-based systemic treatment.      Nivolumab will be administered at a fixed dose of 240 mg every 2 week. Nivolumab will be     given in combination with ipilimumab on week 1, 7, 13 and 19 and will be administered prior     to the infusion of ipilimumab. Ipilimumab will be administered at the dose of 1 mg/Kg.The     patients will receive nivolumab monotherapy on week 3, 5, 9, 11, 15 and 17. From week 21     thereafter, Nivolumab will be then administered every 2 weeks for a maximum period of 1 year     or until disease progression or unacceptable toxicity occurs.   "
20593|NCT03016000|"     This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide     maintenance therapy to prolong relapse-free survival in diffuse large B cell lymphoma(DLBCL).   "
18112|NCT03048448|"     This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of     QAW039 in patients with hepatic impairment compared to healthy matched control subjects.   "
18174|NCT03047642|"     This project aims to evaluate the performance characteristics of rapid tests to differentiate     bacterial from non-bacterial infection in febrile adults and children presenting at OPDs     (outpatient departments) i.e.(fever triage assays) in three LMICs. The evaluation will     include a different commercial biomarker combinations as well as individual biomarkers to     assess their individual or combined value in the target population. Markers will be evaluated     onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a     centralized biobank of well-characterized specimens for use by IVD companies and academic     institutions for the development and evaluation of emerging assays.   "
18069|NCT03049007|"     Psychological distress is a natural reaction following the death of a loved one.     Nevertheless, research has shown that for a significant minority of bereaved individuals the     grieving process is complicated. Instead of decreasing, these individuals experience an     intense grief reaction that becomes abnormally persistent and increasingly debilitating     across time. It has been suggested that this intense, persistent grief reaction meets     criteria to be considered a distinct mental disorder. Prolonged grief disorder (PGD) has been     proposed to capture this condition and is expected to be included in the forthcoming ICD-11.     The proposed project aims to prepare healthcare services to use the diagnosis of prolonged     grief disorder (PGD) by determining the frequency of PDG in a population sample of bereaved     spouses and their adult children. It will also identify early predictors of PGD and common     trajectories of natural and prolonged grief. The mapping of grief trajectories may turn out     to be a potential prognostic tool to identify individuals with high versus low risk of     developing PGD.   "
18070|NCT03048994|"     Severe sepsis is a common condition with high mortality and morbidity. A previous     meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of     mortality and morbidity benefits in critically ill patients. But there is lack of evidence to     recommend the use of intravenous glutamine supplementation in this population group. A     randomized controlled trial which is adequately powered will resolve this issue and can be     included in future international nutrition guidelines for the critically ill. This pilot     study is done prior to a proposed local multi-center study to investigate the effects of     glutamine supplementation.   "
18071|NCT03048981|"     Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has     been reported to increase bleeding in patients through inhibiting platelet aggregation and     prolonging of clot formation time. The Swedish Medical Products Agency recommends that     patients stop taking the naturopathic medicines including fish oil two weeks prior planed     surgery. The aim of this study is to examine the effects of fish oil given to healthy     volunteers using point of care coagulation assessment and flow dependent Cellix instrument     before and after intake of fish oil.   "
18072|NCT03048968|"     The purpose of this study was to investigate the effects of the new wearable hip assist     robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of     Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and brain     activity in elderly adults and stroke patients.   "
18073|NCT03048955|"     PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical     Success of the study group receiving the Superion® IDS is not inferior to the success rate     observed in the study group treated by direct decompression at 60 months follow-up.     Secondarily, the trial is intended to establish that Composite Clinical Success of the study     group receiving the Superion® IDS at 24 months is not inferior to the success rate observed     at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly,     the trial is intended to establish that Composite Clinical Success of the population     receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate     observed at 24 months in patients treated with direct decompression.   "
18074|NCT03048942|"     90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of     chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly     Paclitaxel to determine the difference in progression free survival between the 2 groups. If     results at that stage suggest a potential benefit then the trial will be developed further to     accrue 70 more patients.   "
18075|NCT03048929|"     The overall goals of this study are to examine the relationship between chronic inflammation     and threat and reward sensitivity, and to determine the effects of acute inflammation on     threat sensitivity, in individuals with and without moderate to severe PTSD symptoms. The     investigators will first conduct an observational study to examine the relationship between     chronic inflammation and neural and behavioral measures of threat sensitivity. Then, the     investigators will conduct a randomized, double-blind, placebo-controlled, between-subjects     study to examine the effects of acute inflammation on neural and behavioral measures of     threat sensitivity.   "
18076|NCT03048916|"     Dysphagia after stroke is associated to increased pulmonary complications and mortality. The     swallowing therapies could decrease the pulmonary complications and improve the quality of     life after stroke. The swallowing therapies include dietary modifications, thermal     stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers     used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing     therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate     the brain neuroactivity during swallowing with tasks in normal adults and unilateral     hemispheric stroke patients. The aim of this study is to explore the effect of swallowing     therapies not only in clinical swallowing function but also brain plasticity of acute stroke     patients with dysphagia by videofluoroscopy and fMRI.   "
18077|NCT03048903|"     Random grouping by computer, divided into two groups, a group of rhubarb treatment group,     another group for the placebo group.   "
18078|NCT03048890|"     VascTrac is a mobile medical application that tracks users' physical activity levels in order     to predict endovascular failure of patients with Peripheral Artery Disease.   "
18079|NCT03048877|"     Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is a great challenge     in the treatment of thyroid cancer. Tyrosine kinase inhibitors (TKIs), like sorafenib and     lenvatinib which have been approved by food and drug administration (FDA), could not be     affordable for most of the Chinese patients. Apatinib is a highly selective VEGFR2 inhibitor     and reduces the angiogenesis of tumor efficiently, which had been proven effective in many     solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor     (VEGFR). A phase II study aims to assess the efficacy and safety of apatinib in RAIR-DTC was     enrolled 20 patients, and 10 of them had obtained a shout-term efficacy,the study demonstrate     the peculiar potential in treatment of RAIR-DTC. In this study, the investigators aim to     further explore the efficacy and safety of apatinib in RAIR-DTC.   "
18080|NCT03048864|"     The purpose of this study is to determine if kidney stone patients who should have received     metabolic tests (urine collection over 24-hours that determines the composition of urine)     based on Canadian Urologic Association (CUA) guidelines did in fact receive them, and if     these results were explained to them by their doctor.   "
18082|NCT03048838|"     Epidemiological studies have attributed the source of many new HIV and STI infections among     MSM to primary partners. Despite recent emphasis on couples-based interventions, efficacious     interventions for Latino male couples have yet to be tested. The proposed study builds on the     PI's post-doctoral research in which he adapted evidence based intervention for Black MSM     couples, Connect `n Unite, for Latino male couples using methodologically rigorous adaptation     procedures. The adapted intervention, Conectado Latinos en Parejas (CLP) expands the     prevention alternatives offered in previous interventions by incorporating biomedical     prevention methods such as pre-exposure prophylaxis (PrEP), promoting engagement in care,     adherence to treatment regimens and viral suppression (TasP) and encouraging routine HIV     testing if appropriate given the couple's serostatus. The investigators will conduct a     randomized control trial (RCT) to examine whether participants assigned to CLP report an     increase in the proportion of HIV protected anal sex acts (operationalized as using condoms,     PrEP, TasP) compared to those assigned to a Wellness Promotion (WP) time matched attention     control. The investigators will recruit 150 Latino male couples from the Philadelphia MSA and     randomly assign them to CLP or WP. Participants will complete ACASIs to assess behavioral and     psychosocial factors and be tested for sexually transmitted infections (STI) at baseline, 3     and 6 month post intervention. The investigators will conduct optional HIV/STI testing at     baseline, 3, and 6 month post intervention. The primary study activities will be conducted at     a large Latino serving CBO in North Philadelphia. To our knowledge, this study will be the     first to examine the impact of a couple-based intervention to increase HIV protected anal sex     acts for Latino male couples capable of being scaled up and replicated in various communities     to provide continuous support and protection for this heavily impacted group.   "
18083|NCT03048825|"     The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat     ST elevation myocardial infarction. These treatments address both the culprit artery (PCI     with SYNERGY Stent) as well as the non-culprit arteries (randomization to routine colchicine     and spironolactone).   "
18084|NCT03048812|"     Dental implants are often the preferred treatment option and in some clinical scenarios they     are considered the standard of care to restore missing or damaged teeth, due to the     limitations of conventional treatments. For fully edentulous subjects, conventional     tissue-supported dentures in some cases are associated with severe subjective complaints and     difficult adaptation, mainly the mandibular denture, resulting in limited function and     detrimental effects on oral health-related quality of life, especially for older patients.     The use of implants to retain a mandibular denture (overdenture) has been recommended as a     suitable and low-cost alternative to improve denture stability, with positive effects on oral     comfort and function. The two-implant mandibular overdenture has been considered an effective     design to achieve clinical benefits for patients. However, the main problem facing     two-implant overdenture is the high cost of implantation and the relative complexity of the     surgical intervention, so the use of a single midline implant to retain a mandibular     overdenture was suggested as a more viable solution for reducing costs and complexity of     treatment with similar benefits compared to solutions with higher number of implants.     Nevertheless, there are few studies that compared the performance of different retention     systems and their effects on patient-centered outcomes, such as satisfaction with the     dentures, oral health-related quality of life, individual preferences and other subjective     ratings of clinical outcomes. Thus, the aim of this randomized clinical trial with a     crossover design is to investigate the changes in clinical and patient-reported outcomes     following the use of different retention systems for a single implant-retained mandibular     overdenture Hypothesis: it was hypothesized that clinical and patient-reported outcomes of a     single-implant mandibular overdenture is dependent on the type of retention system, and     patients have distinct preferences in relation to different attachments   "
18085|NCT03048799|"     Post-prostatectomy urinary incontinence (IUPP) is a difficult to treat complication that     causes a profound negative impact on the individual's quality of life, as well as seriously     disrupts the physician-patient relationship and is a substantial public health problem .     Urinary incontinence (UI) can occur both in the treatment of benign prostatic hyperplasia     (BPH) and in the treatment of prostate cancer.      In the treatment of benign disease, this complication is associated with a very low     prevalence, initially of 9% and about 1% in 12 months postoperatively. In radical     prostatectomy, the prevalence is higher, varying from 2% to 87%, depending on the populations     and sites studied, the definitions used, the different methodologies employed in the     evaluation of incontinence, and also the different degrees of intensity of the disease .     Several authors have evaluated the incidence of incontinence after robotic radical     prostatectomy, open and laparoscopically. With these techniques, the reported total UI     incidence varies from 4% to 40% .      With the high prevalence of IUPP, accelerating the recovery of urinary control is an     important priority for patients and their caregivers, and the search for effective and     low-risk treatments is a constant. Thus, the possibility of treatment with the radiofrequency     (RF) feature arises.   "
18086|NCT03048786|"     Despite the availability of a variety of effective treatments for smoking cessation, uptake     of treatments is low. The increasing use of smartphone technology presents an exceptional     opportunity to expand access to low-cost smoking cessation services. In this pilot study, the     investigators will use a text-messaging platform to test peer mentoring for smoking     cessation, delivered by former smokers. While peer mentoring is a common approach to health     behavior change, it has rarely been used to maximum effect by smoking cessation programs. The     text-messaging platform serves as the basis for a randomized controlled trial to test the     effectiveness of peer mentoring for smoking cessation.      This pilot will include approximately 200 U.S. adult smokers who will be randomly assigned to     a peer mentor or not. Participants in the control group will receive automated text messages     used in SmokefreeTXT, a nationwide text-messaging service sponsored by the National Cancer     Institute (NCI) in which users receive one to five automated messages per day for up to eight     weeks. Smokers in the intervention group will receive a modified version of the same     automated messages from SmokefreeTXT, but with additional personalized messages from an     assigned peer mentor. Mentors will provide responses to specific questions or comments a     smoker may have after receiving the automated messages.      The intervention will last 8 weeks. The study includes primary outcomes to measure the     acceptability, engagement, user experience, and early efficacy of the intervention.   "
18093|NCT03048695|"     About 85% of patients with schizophrenia have cognitive impairments, executive functions     being particularly affected. Executive dysfunction, and cognitive deficits in general, are     important predictors of functional outcomes, including social problem solving, activities of     daily living, life satisfaction, and the ability to return to work or school.The main     objective of the current study is to examine the efficacy of group-based Goal Management     Training (GMT) for patients with broad schizophrenia spectrum disorders or high risk     individuals with executive deficits. The short term goals are to investigate whether GMT can     improve participants' ability to organize and achieve goals in everyday life in addition to     improving aspects of emotional health. A long-term goal would be to establish an evidence     base for nonpharmacological interventions for patients with broad schizophrenia spectrum     disorders or high risk for schizophrenia. Main research questions: (1) Does a RCT with GMT     delivered to patients with broad schizophrenia spectrum disorders or high risk for     schizophrenia result in improved executive functioning, measured by self-reported and/or     objective measures of executive functions? (2) Does GMT result in improved goal attainment in     everyday life, social- and real world functioning? (3) Does GMT have a positive impact on the     patients' emotional health? (4) Are there specific characteristics in patients with broad     schizophrenia spectrum disorders or high risk for schizophrenia that are associated with     better treatment benefit from GMT?   "
18087|NCT03048773|"     Knee osteoarthritis is a common disease that causes joint pain, stiffness, and movement     limitation. Nearly 50% in those 75 years and above are affected. In Taiwan, the reported     prevalence was more than 6000 per year. The cause of pain is joint instability and structure     changed, including hyaline articular cartilage lost, bony remodeling, capsular stretching and     periartcular muscle weakness. Current guidelines for treatment of symptomatic knee     osteoarthritis include exercise, anti-inflammatory drugs, transcutaneous electrical     stimulation(TENS) and magnetic fields(MF) which reduce pain and improve the patient's quality     of life.      However, conservative therapies and oral supplements have been evaluated but are without     clear efficacy. Prolotherapy is an injection therapy for chronic musculoskeletal pain. One of     the hypotheses is stimulating local healing and current study demonstrated clinical benefit     for pain and improvement of function. The effects of multi-point injections were more     pronounced in several studies than single-point injection.      Extracorporeal shock wave is common treatment for kidney stones, has been widely used in soft     tissue diseases, such as calcified tendon lesions and plantar fasciitis. The theory of     extracorporeal shock wave is energy of high-frequency vibration caused destruction of stones     and other hard material and by increasing the rate of vascular regeneration in the injured     area and increasing the rate of autologous tissue repair, possible biological processes     include increased mesenchymal stem cell proliferation and differentiation, slowing the     inflammatory response and antimicrobial efficacy. Current studies have shown equivalent     clinical outcomes on calcific rotator cuff tendinopathy among extracorporeal shock wave     therapy, sono-guided acupuncture and arthroscopic surgery and the extracorporeal shock wave     has the advantage of non-invasive treatment.      Taking the advantages of non-invasive treatment of extracorporeal shockwave. We want to     design a randomized control trial by multi-point shockwave therapy and physical therapy     compared with placebo shockwave therapy and physical therapy. Two randomized controlled trial     (RCT) reported improvement in outcomes in response to shockwave therapy but were not     methodologically rigorous. The investigators therefore conducted a two-arm RCT to assess the     hypothesis that adults with symptomatic knee pain receiving shockwave therapy will report     greater improvement in knee-related quality-of-life than sham shockwave therapy.   "
18088|NCT03048760|"     The Christie NHS Foundation Trust is one of seven sites worldwide within the Atlantic     consortium that is developing the Elekta MR-Linac (MRL) prior to commercial release at the     end of 2017. The MRL allows MR images of patients to be acquired before, during and following     radiotherapy (RT). One area where The Christie is taking the lead within the consortium is     the application of the MRL for lung imaging and treatment, an area where MRI has hardly been     used.      MRI scans provide greater soft tissue contrast than CT scans which can aid in the accurate     delineation of organs at risk (OAR) and tumour target volumes for MRL and routine treatment.     In addition, MRI can provide real time imaging which can aid in the accurate motion     characterisation of these volumes. The addition of functional diffusion weighted imaging     (DWI) has also proven to be useful in the discrimination of malignant from benign lesions;     for lymph node detection and for the differentiation of tumour from atelectasis.      Auto-contouring has the potential to speed workflows at various points in the clinical     pathway. This may be inter-patient contour propagation used pre-treatment for plan creation,     or may be during online or offline adaptive workflows propagating contours through imaging     acquired as treatment progresses. In collaboration with industry the investigators will be     testing such algorithms on these images retrospectively.      In addition, the investigators would also like to evaluate patients' experiences of CT and     MRI scans and determine which scanning method is preferred. Other studies have explored     patient experiences of MRI compared to CT but not in the lung cancer patient population.   "
18089|NCT03048747|"     The objective of this study is to investigate the efficacy and safety of tolvaptan based on     the change in serum sodium concentration following administration of tolvaptan oral tablets     at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.   "
18090|NCT03048734|"     This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's     current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results     show that uncontrolled systolic hypertension is independent determinantal of nocturia in     African American men.      We now went to pursue this correlation by designing a new NIH grant Proposal to determine     whether replacing short acting with long acting drugs and dosing them at bed time rather than     in the morning will:      A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better     sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to     nocturia in some patients.   "
18091|NCT03048721|"     Transcriptomics is the study of how RNA is expressed under specific conditions.     Transcriptomic analyses of lesional skin biopsies can be a useful way to track how a patient     responds to a drug and separate out drug responders from non-responders. However, biopsies     are painful, carry risk of bleeding infections and scarring. A non-invasive approach, such as     tape-harvesting, to obtain transcriptomic data from psoriatic skin would increase our     capabilities to monitor patients on treatment and potentially help us predict if the drug     will be effective sooner. However, it is not known how well tape-harvesting can capture     transcriptomic changes that are occurring in psoriatic skin. The purpose of this study is to     address how well tape-harvesting captures the transcriptomic changes that are occurring in     psoriatic skin.   "
18092|NCT03048708|"     This study is expected to provide novel data regarding potential structural and functional     changes of the thyroid gland in morbidly obese adults following significant weight loss     through bariatric surgery. These data will complement evidence from epidemiological studies     regarding the association of obesity and alterations in thyroid function. Potentially this     study may justify further longer-term studies regarding the effects of weight gain and/or     weight loss on the morphology of the thyroid gland and could help to form recommendations     regarding follow-up investigations for the thyroid in morbidly obese patients.   "
18094|NCT03048682|"     This study is a randomized controlled trial designed to assess the rate of failure of voiding     trials in the early and late post-operative period within patients who underwent outpatient     pelvic floor surgery that failed initial same day voiding trials.   "
18108|NCT03048500|"     The purpose of this study is to find the benefits of combining nivolumab with metformin in     advanced non-small cell lung cancer with and without prior treatment with immunotherapy. We     will also be looking at the safety of the combination. Nivolumab is currently approved in     certain cancers such as melanoma, lung cancer and kidney cancer. Metformin is approved by the     US Food and Drug Administration (FDA) to treat diabetes. In this study, Metformin is being     used to treat cancer. This use is not approved by the FDA; therefore, in this study, it is     considered experimental. Experimental means the U.S. FDA has not approved the drug for use in     your type of cancer. Nivolumab is an antibody (a human protein that sticks to a part of the     tumor and/or immune cells) designed to allow the body's immune system to work against tumor     cells. It is believed that metformin has immune modifying properties, meaning it can boost     your immune system. As a result, it may help certain cancer treatments, known as     immunotherapy, to work better.   "
18095|NCT03048669|"     Despite the rapid adoption of the World Health Organization's 2013 guidelines, many children     continue to be infected with HIV perinatally because of sub-optimal adherence to the     continuum of HIV care in maternal and child health clinics (MCH). To achieve the UNAIDS goal     eliminating mother-to-child HIV transmission, multiple, adaptive interventions will need to     be implemented to improve adherence to the HIV continuum. The aim of this open label,     parallel groups, randomized controlled trial is to evaluate the effectiveness of Continuous     Quality Improvement (CQI) interventions implemented at facility and health district level to     improve retention in care and virological suppression through 24 months postpartum among     pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic     Republic of Congo. Prior to randomization, the current monitoring and evaluation system will     be strengthen to enable collection of high quality individual patient-level data necessary     for the timely production of indicators and monitoring of program outcomes to inform CQI     interventions. Following randomization, in health districts randomized to CQI, quality     improvement (QI) teams will be established at the district level and at MCH clinics level.     For 18 months, QI teams will be brought together quarterly to identified key bottlenecks in     the care delivery system using data from the monitoring system, develop an action plan to     address those bottlenecks, and implement the action plan at the level of their district or     clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in DRC     and other resource-limited settings to accelerate progress towards the goal of an AIDS free     generation.   "
18096|NCT03048656|"     The structural leg-length inequality caused by the shortening of a segment of an extremity,     results in an altered position of lower limb joints, the pelvis and the spine in static as     well as dynamic conditions. That may induce a disturbance of the postural control.      The objective of this study is to investigate the effect of the structural LLD on the control     of the posture.   "
18097|NCT03048643|"     Hospitalizations for severe infections associated with opioid use disorder (OUD), such as     infective endocarditis (IE), have doubled in the US over the past decade and are frequently     prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug     use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with     IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more)     largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD     infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine     or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug     use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT     (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional     outpatient care program supporting MAT, may support provision of outpatient IV antibiotic     therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to     evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due     to opioid use disorder in the hospital for the full duration of antibiotic treatment)     compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically     stable).   "
18098|NCT03048630|"     In this intervention study, the investigators engage Vietnamese American nail salon owners to     train workers within their salons on how to reduce workplace chemical exposures. The     long-term goal of the study is to reduce toxic chemical exposures in nail salons and promote     worker health and safety in this vulnerable worker population.   "
18099|NCT03048617|"     This is an observational study of patients with Primary Mitochondrial Disease with either     signs or symptoms suggestive of myopathy. The Investigator will identify potential patients     through existing medical records and one on-site visit.   "
18100|NCT03048604|"     The study is designed as a prospective, open-label, multicentre, non-randomized, single arm     treatment study to assess the safety, performance and initial efficacy trends of the GenioTM     System in patients with Obstructive Sleep Apnoea (OSA).   "
18101|NCT03048591|"     Through the research to confirm the effectiveness and safety of using electroacupuncture in     the treatment of chemotherapy-induced peripheral neuropathy.   "
18102|NCT03048578|"     This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo     over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y     gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy     of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids,     HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health     Questionnaire), versus placebo in patients at least 18 months following RYGB who are     experiencing weight regain as well as the safety of liraglutide in this patient population.   "
18103|NCT03048565|"     This is a pilot feasibility study testing a mindfulness based intervention with caregivers of     people with chronic illnesses   "
18104|NCT03048552|"     Developed from adapting and combining two evidence-based programs, Project CONNECT (a     linkage-to-services program that targets barriers within the probation and substance abuse     treatment systems) and TIES (a program that teaches family engagement skills to providers),     Family CONNECT is a linkage-to-services program that targets both family and system-level     factors to increase youth use of and retention in substance use services. Using Linkage     Specialists embedded within probation departments, Family CONNECT will be implemented in two     NYS probation departments. This proposed study will evaluate the impact of Family CONNECT on     (1) youth referral from probation to substance abuse treatment, (2) youth and family     engagement in substance abuse treatment, (3) youth enrollment/retention in substance abuse     treatment, and (4) youth substance use and recidivism. This study will also identify family     and probation organizational factors influencing Family CONNECT implementation in probation     settings. 50 (+2 pre-pilot) caregiver-youth dyads and up to 36 probation officers will be     recruited as participants in the study. Caregiver-youth dyads will be evaluated at baseline,     2 and 6 months; probation officers at baseline, 6, 12, and 18 months; linkage specialists at     baseline, 6, 12, and 18 months. Counts of youth referred, youth who start treatment, and     youth retained in treatment will be obtained from the juvenile justice agency at     pre-implementation, baseline, 2 and 6 months, counts of youth recidivism will be obtained at     2 and 6 months.   "
18105|NCT03048539|"     The purpose of this study is to determine the quality of life of transoral endoscopic     thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will     be assessed, also.   "
18113|NCT03048435|"     Concurrent chemo-radiotherapy followed by intracavitary brachytherapy is standard of care for     patients with locally advanced cervical cancer. Although curative, this treatment is     challenging and leaves a significant proportion of women with severe toxicity, negatively     impacting their quality of life. Although most recover over time, a proportion of women do     not. Therefore, evaluation of quality of life becomes increasingly more important as cancer     specific outcomes improve. One such method is through patient-reported outcomes (PROs),     defined as any report coming directly from the patient about a health condition and its     treatment. This prospective multi-institutional study, involving the Princess Margaret (PM),     Odette Regional Cancer Centre(ORCC) and Royal Victoria Regional Health Center (RVH), will     assess to feasibility and acceptability of integrating a cervical cancer specific PRO     measurement tool into clinical practice. Cervical cancer patients coming for follow-up     appointments will be asked to complete the EORTC QLQ-CX24, a validated cervical cancer     specific PRO questionnaire. At the end of the study period, Feedback Forms will be completed     by participating patients and health care providers to obtain their perspectives regarding     the feasibility and acceptability of incorporating the instrument into clinical practice.     Future directions include designing an electronic platform and expanding its use in cervical     cancer clinics provincially and nationally. The data collected should help identify     disease-related symptoms, treatment-related toxicities, facilitate patient-physician     communication, shared treatment planning and target intervention strategies.   "
18114|NCT03048422|"     The purpose of this study is to compare the virologic efficacy and safety of three     antiretroviral (ARV) regimens in HIV-1-infected pregnant women and to compare the safety of     these regimens for their infants.   "
18115|NCT03048409|"     A retrospective chart review to assess feeding tolerance in adults who had been switched from     an intact protein formula to a peptide-based formula due to feeding intolerance in a complex     continuing care facility.   "
18116|NCT03048396|"     Transplantation of an uterus   "
18117|NCT03048383|"     The purpose of this study is to compare the effectiveness of three commercially available     botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported     outcome measures.   "
18118|NCT03048370|"     This study aims to determine if individuals with schizophrenia have greater reactivity to     vestibular stimulation than healthy controls. The physiological response of vestibular     stimulation will be assessed with electronystagmography, which provides a measure of the     intensity of the nystagmus via PSPV. Positive results would suggest greater vestibular system     reactivity to vestibular stimulation may be a biomarker of schizophrenia.     Pathophysiologically, increased vestibular reactivity to vestibular stimulation may reflect     abnormal vestibular function or impaired central suppression of the vestibular ocular reflex.   "
18119|NCT03048357|"     Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated     Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours     on a standard Hospital Bed.   "
18120|NCT03048344|"     Part 1 will be conducted as an open-label, non-randomized, non-placebo-controlled dose     escalation study using pre-specified doses. Subjects with the following advanced     hematological disorders and no available therapies, and who satisfy all inclusion/exclusion     criteria will be enrolled.      Part 2 will consist of an initial randomized, open-label, 3-sequence, 3-period, crossover     study to evaluate the bioavailability of a single dose of oral ORH-2014 administered in the     fed or fasted state (at the MTD or recommended dose identified in Part 1) compared to a     single dose of IV Trisenox administered at a dose of 0.15 mg/kg.      Part 3 will be an expansion phase conducted as a single-arm, open-label study to further     evaluate the safety and tolerability of ORH-2014 at the MTD or recommended dose. Subjects     with the same disease types as in Part 1 will be enrolled. All subjects will receive oral     ORH-2014 at the MTD or recommended dose for an initial period of up to 12 weeks.   "
18121|NCT03048331|"     FES is a common and established method in the rehabilitation of persons with spinal cord     injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding     disuse and denervation atrophy, improving muscle force, power output and endurance changing     muscle fibre type, increasing cross sectional area of muscle, increasing muscle mass,     activation of nerve sprouting, reducing spasticity and motor learning.      Most of the studies investigated the impact of FES in the lower limbs. For the upper     extremities fewer studies exist. However, it is supposed that the effects of FES are similar.      In the rehabilitation of persons with tetraplegia, FES, especially the stimulation of the     upper extremities triggered by electromyography (EMG) is an established method to generally     improve hand and arm function. However, none of those studies has investigated the effect of     FES in combination with reconstructive tetraplegia hand surgery. Improved muscle strength is     supposed to improve the functional outcome in participation. Additionally, FES could increase     the motor learning process. Supported by the clinical observation we hypothesize that FES has     a positive influence on the outcome of surgical reconstruction of tendon and/or nerve     transfers.   "
18122|NCT03048318|"     Arterial flushing is a standard recommendation in deceased donor liver transplantation but     not in living donor liver transplantation due to the risk of arterial intimal injury and     short cold ischaemia time. There is recent evidence on benefit of retrograde arterial     perfusion using hepatic venous occlusion and its benefits on post transplant cholestasis.     However there is no data on antegrade arterial flushing.   "
18123|NCT03048305|"     The investigators collect nasopharyngeal epithelium samples from healthy individuals and     analyze for biomarkers compared with tumor tissues from another clinical research project.     The goal of this study is to identify molecular biomarkers for prediction of nasopharyngeal     carcinoma.   "
18173|NCT03047655|"     A growing number of cross-sectional studies is investigated the role of the human lipidome as     a new biomarker for metabolic diseases. However, data on this issue is still sparse and     especially interventional data is not available up to now.      GesundLeben will provide data on 100 human subjects with metabolic syndrome, undergoing     distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will     be covered with routine laboratory parameters and oral glucose tolerance test as well as     non-radiologic anthropometric measurements.   "
19137|NCT03035058|"     The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous     (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying     inflammatory bowel disease (IBD).   "
18124|NCT03048292|"     Endovascular treatment has recently become the recommended therapy for acute stroke after the     publication of five randomized trials (MR CLEAN1, ESCAPE2, EXTEND IA3, SWIFT PRIME4,     REVASCAT5) in 2015 that demonstrate its efficacy. Hospitals need to adapt to these updated     stroke care guidelines, and many hospitals are not appropriately equipped for     neurointerventional procedures. Decreased time to treatment is associated with favorable     clinical outcomes, and best practices to optimize workflow between comprehensive stroke     centers and secondary hospitals have become an important area of study. This prospective     study is being conducted on acute stroke cases within the Mount Sinai Health System from 1     June 2016 up until 31 December 2018. The researchers would like to evaluate how variable     methods of interventional service delivery for acute stroke affect clinical measures and     outcomes.      More specifically, the researchers are conducting this study in order to determine whether     outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting     to and receiving treatment at a comprehensive stroke center, will be superior to that     delivered by a mobilized intervention team at a central satellite hospital. In particular,     the hypothesis is that factors affecting outcome include presentation to secondary hospital,     delays with transfer including traffic conditions and time of day, and the acquisition of     complex imaging within secondary hospitals.   "
18125|NCT03048279|"     Objectives:      To contribute new and prospective data to our existing database library for patients with     MEN1 and MEN2 at The University of Texas M.D. Anderson Cancer Center.   "
18126|NCT03048266|"     Objectives:      The aim of the present study is to assess the significance of metabolomics and genetics in     diagnosing and survival evaluation for pNET in the periodic follow-up of MEN1 patients.      Aim 1: To evaluate the relationship of serum global metabolic profiles with subsequent     development of aggressive PNET and evaluate patients survival in a nested case-control study     of MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have     developed non-aggressive PNETs (controls).      Aim 2: Validate the top serum metabolites identified from Aim 1 in MEN1 patients who have     developed aggressive PNETs and MEN1 patients who have developed non-aggressive PNETs, using a     targeted metabolomics approach.      Aim 3: Prospectively identify the potential miRNA biomarkers of serum with miRNA sequencing     in MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have     developed non-aggressive PNETs (controls).      Aim 4: Validate the potential miRNA biomarkers identified from Aim 1 in MEN1 patients who     have developed aggressive PNETs and in MEN1 patients who have developed non-aggressive PNETs,     using a targeted qRT-PCR approach (in serums), as well as to see the relationship of     potential miRNA biomarkers with patients survival.   "
18127|NCT03048253|"     Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically     engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as     the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively     removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the     original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug after tumor     site local injections of dosing, on the one hand, because of the soluble tumor     characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the     injection site specific soluble tumor kill tumor cells;Viral vector expressed in tumor     site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor     immune function, play beside the destruction effect, have inhibition effect on the distant     metastases.   "
18128|NCT03048240|"     The study pilot evaluate the feasibility of a 5-ALA- PpIX (protoporhyrin IX) mediated     per-PDT protocol in patients with glioblastoma accessible for complete surgical removal of     contrast. This treatment will be carried out in addition to the current reference treatment     of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the     protocol Stupp   "
18129|NCT03048227|"     During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM)     in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will     participate in two period of 3 months separated by a 3 months washout. During one period,     they will use CGM to adapt their insulin therapy while during the other period, they will     manage their diabetes with their usual capillary blood glucose meter. We except to observe an     increase of time spent in glucose safe range when using CGM.   "
18130|NCT03048214|"     This study aims to investigate whether infraclavicular nerve block improves acute     postoperative pain after distal radial fracture surgery.   "
18131|NCT03048201|"     The primary objective of this study is to obtain long-term implant survivorship (out to 10     years) and to assess clinical, patient-reported outcome measures, and radiographic data for     the commercially available Physica system.   "
18132|NCT03048188|"     Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds     aim at reducing infection and improving reepithelialization. The aim of this study is to     evaluate time to reepithelialization, pain, microbiology and handling of manuka honey     dressings with second-degree burn wounds and split-skin grafted burn wounds.   "
18133|NCT03048175|"     Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry.     Nevertheless, little is known about the level of general body inflammation of subjects with     impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of     wisdom teeth on the overall health are not known.      Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by     bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group     comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without     pathology associated to or history of previous extraction of both wisdom teeth.      In both groups a medical and dental examination will be performed at the baseline and 3     months after baseline for the control group or after the second third molar extraction in the     control group. Blood will be also withdrawn to assess systemic inflammation and other     systemic parameters.      Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen,     oxidative stress and endothelial function analysis.   "
18134|NCT03048162|"     This study is aimed to assess the effects of intravenously administered three fluid types on     perfusion index and pulse variability index in patients during preoperative period. Patients     will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th     min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion     index and pulse variability index will be measured and recorded.   "
18139|NCT03048097|"     In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based     on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET     study will be considered for this study. The study will test the following Aims:      Aim 1. Effect of FDG incubation time on visual and quantitative interpretation of FDG uptake.      Changes in incubation time can affect imaging target:background ratios and study     sensitivity/specificity. For the study-directed exam, all patients will undergo sequential     cardiacfocused FDG-PET imaging at 90 and 120 minutes after injection of FDG. Imaging     variables will be evaluated as below.      Aim 2. Reproducibility of FDG and Rb82 PET findings on sequential imaging. It is unknown     whether FDG-positive imaging findings in cardiac sarcoidosis are reproducible. All patients     will undergo study-directed FDG-PET/CT with MPI imaging within approximately 2 weeks from     initial clinical scan.   "
18140|NCT03048084|"     Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians'     preference, as there are no studiessupporting the use of one specific anticonvulsant in     glioma patients. The overall aim of this randomized controlled trial is to directly compare     the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a     first seizure.   "
18141|NCT03048071|"     Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart     defects can directly affect the right ventricular ejection tract (RVOT), or sometimes     indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross     operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT     by valved homografts is since then widely used.Pulmonary and aortic homografts then     constituted the gold standard in conduit replacement between the right ventricle and the     pulmonary artery (VD-AP).      The increasing demand for homografts currently induces a shortage and unmet demands. This     lack of availability, and the durability of homografts in young patients, has encouraged the     search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein     xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for     RVOT reconstruction. This duct naturally has a central valve with three valvules, and there     is on both sides of the valve a generous duct length allowing unique adaptation options. This     conduit, however, is not perfect.      Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study     is to compare operative morbidity and mortality when replacing Contegra® or homograft.   "
18142|NCT03048058|"     An investigator-blinded, prospective, 6 month study of subjects with persistent erythema     associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All     subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to     apply it once daily per package insert. Adherence will be assessed using weekly internet     surveys to document how often the medication is being used, as well as reminders about     rosacea triggers and general use of brimonidine.   "
18143|NCT03048045|"     Patients who had had systematic periodontal treatment (antiinfective treatment with     subgingival debridement under local anaesthesia and if required periodontal surgery) at the     Dept. of Periodontology starting from October 2004 are re-examined 10 years +/- 12 months     after accomplishment of active periodontal therapy (re-evaluation 1 or 2, start of supportive     periodontal treatment) until 100 patients have been enroled. Radiographs (periapicals or     panoramics) from start of treatment should be available.   "
18144|NCT03048032|"     LEDA (Lithuanian Echocardiography study of Dyspnea in Acute settings) is a prospective     observational cohort multicenter clinical study. Project is carried out by Vilnius University     together with a partner Lithuanian University of Health Sciences, in conjunction with a     research protocol of international GREAT consortium (Global Research on Acute Conditions     Team). The aim of this project is to find the specific novel biomarkers of acute heart     failure (AHF), to evaluate their diagnostic and prognostic role in association with     echocardiographic parameters of AHF. Primary endpoint is 1-year all-cause mortality and     rehospitalization. Secondary endpoints are 1) in-hospital all-cause mortality 2)     post-discharge 1 and 3 month all-cause mortality and rehospitalization 3) post-discharge 1     and 3 month cardiovascular mortality and rehospitalization 4) one-year cardiovascular     mortality and rehospitalization.      During the project a sizeable national database (2000 Lithuanian patients) will be integrated     into database of GREAT network. Novel cardiac biomarkers together with ultrasound parameters     of right ventricular (RV) function are in the focus of the study. During the acute phase of     heart failure, up to 15 novel cardiac, vascular, renal impairment and inflammation biomarkers     in plasma samples will be investigated in Lithuania and France (INSERM laboratory). Plasma     samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch     analysis. The extensive evaluation of innovative ultrasound parameters of right ventricular     structure and function will be performed in the early hospitalization period, along with     standard echocardiography examination. The first database of AHF patients in Lithuania will     provide demographic data and trends of morbidity and mortality, as well as analysis of     diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the     Baltic region. Quantitative parameters of RV systolic function and deformation will be     measured. It is expected that optimal use of novel biomarkers and reproducible     echocardiography parameters in the setting of emergency and critical care would reduce     unnecessary hospitalizations, cost and hospital length of stay without decrease in the     quality of diagnostics and treatment. An estimation of correlation of echocardiographic     parameters and biomarkers could help create an accurate algorithm for risk stratification and     diagnosis of AHF in an emergency setting.   "
18145|NCT03048019|"     Immediate potent inhibition of platelet function is critical for the prevention of     periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial     infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI).     Currently, dual antiplatelet therapy with aspirin and an oral P2Y12 receptor blocker (with     loading doses) is widely used for PCI. However, immediate, potent and reversible inhibition     of platelet aggregation is not possible even with the newer oral agents, prasugrel and     ticagrelor. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor     (tirofiban) or P2Y12 receptor blocker (cangrelor) with fast onset and offset of actions will     provide more desired antiplatelet effects in the setting of PCI. This study will measure and     compare the anti-platelet effects of Tirofiban and Cangrelor in patients presenting with     N-STEMI and undergoing PCI.   "
18146|NCT03048006|"     Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic     Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim     of this study, which was conducted in accordance with section 67, paragraph 6 of the German     drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic     efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI     techniques and application methods.   "
18147|NCT03047993|"     The goal of this clinical research study is to learn if CB-839 given in combination with     azacitidine can help to control the disease in patients with myelodysplastic syndrome (MDS).     The safety of this drug combination will also be studied.   "
20594|NCT03015987|"     the investigator intended to study the effect of laser versus ultrasonic in activation of     irrigation in post operative pain of patients have a symptomatic necrotic teeth   "
18149|NCT03047967|"     Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on     smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although     environnemental tobacco smoke exposure effects are well known, consequences of prenatal     tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our     group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial     structure similar to those observed in KO α7-nAChR mouse pups. These findings support the     hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco     smoking on respiratory epithelium development. The purpose of the present clinical study is     to compare PTSE neonates with controls according to lung function and respiratory epithelial     functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained     from gentle nasal brushing performed under antalgic premedication according to the method we     previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and     CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be     performed, by means of baby-body plethysmography.   "
18150|NCT03047954|"     The objective of this pilot double-blind study was to evaluate the efficacy and the safety of     Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the evolution of     the disease in children suffering from Atopic Dermatitis (AD).   "
18151|NCT03047941|"     The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA,     STOP-Bang, P-SAP, and OSA50.      The aim of this study is to evaluate the optimal cutoff value of these four scores to detect     specifically serve OSA patients with hypoxemia.   "
18152|NCT03047928|"     Combination therapy is becoming more and more general in the treatment of oncological     diseases. In this clinical trial combination the standard immunotherapeutic treatment; the     programmed death 1 (PD-1) regulatory antibody Nivolumab and a peptide vaccine consisting of     programmed death ligand 1 (PD-L1) and Indoleamine 2,3-dioxygenase (IDO) peptides will be     tested in patients with metastatic melanoma. Patients will be treated with Nivolumab every     second week as long as there is clinical benefit. The PD-L1/IDO peptide vaccine is given from     start of Nivolumab and every second week for the first 6 vaccines and thereafter every fourth     week up to 1 year.   "
18153|NCT03047915|"     This will be a randomized controlled study evaluating the effect of a music-listening     intervention compared to standard care (control) during patient visit to the emergency     department (ED). Randomization will be done with consecutive sealed envelopes.      Data collection will be prospective with administration of the State Trait Anxiety Inventory     and collection of physiologic parameters (pain level, heart rate, blood pressure).     Retrospective data will also be collected for covariate analysis (age, race/ethnicity,     emergency severity index (ESI), pain medications administered during the ED visit, pain     scores throughout ED visit, chief complaint, and ED discharge diagnosis).   "
18154|NCT03047902|"     This is an exploratory randomised matched cohort pilot study. It is hypothesised that     adolescents (aged 13-16 years) with asthma attending a secondary care outpatient asthma     clinic, will disclose their smoking status to a doctor or nurse, if questioned alone without     a parent present and if advised that they will have biological validation of their smoking     status using a carbon monoxide monitor. It is a study of 30 subjects, who will be recruited     over a period of 6 months.   "
18155|NCT03047889|"     To study the epidemiological trends and characteristics for advanced breast cancer patients,     to analyze these trends and report the results   "
18156|NCT03047876|"     Many neonates and infants who undergo complex cardiac surgery are affected by neurological     developmental delays. Whilst catastrophic events are immediately identifiable from clinical     examination or by macro changes on MRI or CT scans, smaller changes are often not immediately     visible or detected.      This is an observational pilot study examining brain vascular reaction to hypothermic     circulatory arrest with antegrade cerebral perfusion and neuro-protection techniques during     aortic arch surgery in neonates and infants. A combination of duplex ultrasound and     transcranial doppler will be used to record in-depth information on the cerebrovascular     changes that occur during the entire length of the surgical procedure and during the early     postoperative period. The proposed techniques and equipment are non-invasive and are in use     clinically to evaluate brain perfusion in a similar age group.      During aortic arch surgery, the patient's body and brain temperature is reduced to values     between 18 and 24 degrees centigrade in order to decrease metabolic demand that provides a     form of metabolic protection. However, there is no consensus within the clinical community     regarding the optimal temperature at which to perform surgery. Moreover, in order to improve     cerebral perfusion, the brain is perfused via the right internal carotid artery with cold     blood. At Alder Hey Children Hospital, this surgery is undertaken by the three surgeons but,     due to clinical preference, differs in relation to the temperature at which surgery is     undertaken. This provides the opportunity to observe the impact of different temperatures on     cerebral vascular reactivity in neonates and young infants The arguments for future     comparisons and a larger randomised study will be made based on the information gained from     this observational study.   "
18157|NCT03047863|"     The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for     dermatologic adverse events related to EGFR inhibitors.   "
18158|NCT03047850|"     Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This     study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and     Delta Down.   "
18172|NCT03047668|"     Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle.     Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted     by pharmacological intervention, although lifestyle modification and dietary treatment would     be favourable.      The researchers therefore investigate dietary strategies such as low-carb and very-low calory     diets regarding their potential to improve metabolism and body weight in (mostly) long-term     T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).      POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements     from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.   "
18308|NCT03045900|"     There is a deficiency in literature which compares the blending effect and color matching of     translucent shade bulk-fill resin composite with shaded bulk-fill resin composite. So in this     research color matching and blending effect will be instrumentally measured the by a     spectrophotometer. A visual assessment also will be done in-vivo and ex-vivo.   "
18159|NCT03047837|"     Epidemiological studies and cardiovascular prevention trials have shown that low-dose aspirin     (ASA) can inhibit colorectal cancer (CRC) incidence and mortality, including inhibition of     distant metastases. Metformin (MET) has also been associated with decreased CRC incidence and     mortality in meta-analyses of epidemiological studies in diabetics and has been shown to     decrease by 40% colorectal adenoma recurrence in a randomized trial. Recent studies have     shown that ASA is an inhibitor of mTOR/S6K1 and an activator of AMPK, targeting regulators of     intracellular energy homeostasis and metabolism, and that the combination of ASA and MET,     another AMPK activator and S6K1 inhibitor, has a striking additive effect on AMPK activation     and mTOR inhibition, with increased autophagy and decreased cell growth in CRC cell lines.     While both drugs are being tested as single agents, their combination has not been tested in     trials.      This is a randomized, placebo-controlled, double blind, 2x2 biomarker trial of ASA and MET to     test the activity of either agent alone and the potential synergism of their combination on a     set of surrogate biomarkers of colorectal carcinogenesis. After surgery 160 patients with     stage I-III colon cancer will randomly be assigned in a four-arm trial to either ASA, 100 mg     day, MET 850 mg bid, their combination, or placebo for one year. The primary endpoint     biomarker is the change, defined as the difference between pre- and post-treatment expression     of nuclear factor kappa-B (NFκB), in the unaffected mucosa of proximal and distal colon     obtained by multiple biopsies in two paired colonoscopies one year apart. Additional     biomarkers will include: 1) the genomic profile of candidate genes, pathways, and overall     genomic patterns in tissue biopsies by genome wide gene expression arrays; 2) the IHC     expression of tissue pS6K, p53, beta-catenin, PI3K; 3) the associations of mutations and SNPs     with treatment response by next generation sequencing of primary tumors; 4) the measurement     of circulating IL-6, CRP and VEGF and 5) plasma and colonic MET concentrations and their     correlation with biomarker profiles.   "
18160|NCT03047824|"     After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion     Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate     treatment cohort will then be consecutively enrolled, followed by the tight glycemic control     cohort.      After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory     evaluations will be determined.      Subjects enrolled in the standard of care cohort will be treated according to the     institution's protocol for measuring glucose and managing insulin. These subjects will be     monitored on a GlucoClear System but they will not be managed based on the values or trends     of the GlucoClear system.      Subjects enrolled in the treatment cohorts will be monitored and managed with a special     version of the GlucoClear continuous monitoring system. This system contains the GlucoClear     Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to     manage patient glucose within pre-specified target levels. These recommendations are     presented on screen for a clinical professional to approve or override.      Subjects in the moderate treatment cohort will have their glucose managed in the range of 120     - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the     range of 80 - 120 mg/dl.      After discharge from the ICU, subjects will followed for adverse events and mortality at 30     days, either by telephone contact or office visit.   "
18161|NCT03047811|"     The study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells     treatment of advanced solid tumors        1. The main purpose - security and ORR;        2. A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years          survival rate;The quality of life.   "
18162|NCT03047798|"     This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo     salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque.     Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica     extracts and the same participants will also use placebo for tooth brushing by cross-over     design.   "
18163|NCT03047785|"     Currently when defining the upper limit of normal (ULN) or 99th percentile of a troponin     assay manufacturer's use a healthy population traditionally aged 18-40. The 99th percentile     value is the recommended value to use when diagnosing patients with an acute myocardial     infarction. With the advent of the new highly sensitive troponin assays it has become clear     that many patients have a troponin level above the 99th percentile when they have not     suffered a myocardial infarction. We believe part of the problem with interpreting the the     troponin values for patients is that the 99th percentile value which determines the ULN has     been derived from population that is very different to the hospital population of patients.     This study aims to demonstrate what the 99th percentile is for the population of people who     use the hospital services who are traditionally older and have more comorbidities when     compared to the population traditionally used to define the 99th percentile of a troponin     assay.   "
18164|NCT03047772|"     The benefit of current stem cell transplantation therapy for myocardial infarction is limited     by low survival rate for stem cell. The purpose of this study is to test whether intensive     Atorvastatin therapy can improve the outcome of patients with impaired left ventricle     function after acute myocardial infarction who underwent intracoronary transfer of autologous     bone marrow mesenchymal stem cells.   "
18165|NCT03047759|"     Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.   "
18166|NCT03047746|"     This is a single arm pilot study using TCR alpha/beta+ T cell-depleted peripheral blood stem     cells (PBSC) from closely matched unrelated donors or partially matched/haploidentical     related donors for hematopoietic stem cell transplant (HSCT) in patients with acquired and     inherited bone marrow failure (BMF) syndromes.   "
18167|NCT03047733|"     OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the     conventional continuous excimer laser treatment.      DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was     performed in two tertiary health care centers in Korea.      PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5     years' disease duration were enrolled.      INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the     continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month:     continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles).     Topical tacrolimus was applied throughout the trial.      OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with     clinical photographs. The primary outcome was mean difference of repigmentation rates and the     non-inferiority margin was set at 10%. During intermission period, the clinical changes such     as loss of repigmentation or worsening of the vitiligo lesions were assessed.   "
18168|NCT03047720|"     This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any     effect on benign nocturnal enuresis.   "
18169|NCT03047707|"     The purpose of this multi-center prospective study is to evaluate the diagnostic performance     of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of     hepatic fibrosis.   "
21908|NCT02998840|"     The purpose of this study is to evaluate and compare the efficacy of B244 in treating     patients with hypertension.   "
18176|NCT03047616|"     Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with     clinical trials showing an approximately 20% durable response in unselected patients with     advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to     accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly     discover and evaluate the utility of blood based biomarkers for use in measuring and     predicting response to immunotherapy in patients with lung cancer.   "
18177|NCT03047603|"     The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC     cases were at advanced stage when the diagnosis established.Early diagnosis improves the     prognosis.The study is intended to evaluate the diagnostic efficiency of Protein Induced by     Vitamin K Absence or antagonist-II(PIVKA-II). This study is a international multicenter study     joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including     healthy control,HCC,metastatic liver cancer,Hepatitis B virus(HBV) and liver cirrhosis are     consecutively recruited into the cohort. All the serum samples are collected before any     treatments and will be tested in single center in order to decrease bias. Serum samples were     tested for PIVKA-II,alpha-fetoprotein and biochemical indexes including alanine     aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl     transferase(GGT),alpha-l-fucosidase(AFU),etc.   "
18178|NCT03047590|"     This study will evaluate adherence to four types of walking programs. Participants will be     randomized to walking programs that included either (1) affect-based exercise intensity, (2)     self-selected (or choice-based) exercise intensity, (3) heart-rate based exercise     intensity, or (4) heart-rate guided exercise intensity with the emphasis on affective     benefits.   "
18179|NCT03047577|"     Patients non-electively admitted to intensive care units (ICUs) will be screened for     eligibility. The investigators will include adult patients with risk level alcohol use,     defined by AUDIT-C score (>5 for females, >6 for males). Informed consent will be obtained     from the patient in the end or shortly after the ICU treatment, when they have regained     sufficient cognitive function. 600 patients will be randomized to receive either routine     treatment or a brief intervention (BI). The BI includes a 20 minute discussion with     pre-educated study personnel, option to discussion with a social worker and written material.     Primary outcome measure is the amount of alcohol used during the preceding week (g/week), at     6 and 12 months after study entry. The information will be obtained 1)in an interview by a     study team member blinded for the intervention arm at 6 months 2) A letter of a telephone     interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded.   "
18180|NCT03047564|"     Metal ion release from metal implants may have side effects. It can be reduced by coating of     the implant. This study compares coated and uncoated TKA.   "
18181|NCT03047551|"     The investigator will perform a multicenter, randomized controlled trial in practices that     routinely use transvaginal sonography (TVS) to compare how often clinicians order additional     testing prior to medical abortion after the use of either TVS or transabdominal ultrasound     (TAS) in medical abortion eligibility assessment. Women will be randomized to receive either     TVS or TAS prior to medical abortion. We anticipate enrolling 800 patients receiving care     from about 30 providers over 6-8 months.      The primary study outcome will be the proportion of women that requires additional evaluation     after sonography, prior to determination of medical abortion eligibility. The second primary     outcome will be patient satisfaction, determined by a patient satisfaction questionnaire     utilizing a visual analog scale.   "
18182|NCT03047538|"     The aim of this study is to compare the effect of fixed and free combination of     atorvastatin/perindopril/amlodipine on blood pressure and lipid levels.   "
18183|NCT03047525|"     Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and     Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer     cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will     improve the prognosis of advanced solid tumors.      Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy     with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.      Study treatment:      Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments     within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available     in both groups.   "
18202|NCT03047278|"     This study aims to investigate the influence of the glycemic control of type 2 diabetes (DM2)     and of cetirizine (OCT2 inhibitor) on gabapentin kinetics disposition and     pharmacokinetics-pharmacodynamics (PK-PD) in patients with neuropathic pain. Thus,     non-diabetic patients (Control Group, n=10), patients with controlled diabetes (n=10) and     patients with uncontrolled diabetes (n=10), all with neuropathic pain of intensity ≥ 4 in     pain visual analog scale (0-10) are being investigated.   "
18184|NCT03047512|"     Major depression is a highly prevalent and severe mental disease that negatively alters the     lives of people, their families, and their social environment.      Organizations that promote mental health policies have recognized the potential of new     information technologies for the prevention and treatment of mental disorders. In this     direction, information and communication technologies (ICTs) generate opportunities for     increasing patient well-being through the use of on-line software. Such programs often     include interactivity, self-monitoring, information materials (sometimes in multimedia     format), and exercises on problem solving, recognition and challenging of dysfunctional     thoughts, scheduling of activities, behavioral experiments, and other psycho-educational     activities.      In Colombia, there are few preventive mental health interventions scientifically oriented and     seeking to demonstrate efficacy in context.      The purpose of this study is to determine whether an internet-based program is effective to     prevent and to intervene early the depression in adolescents between 11 and 20 years of age     in 2 schools in the Antioquia Region, Colombia.   "
18185|NCT03047499|"     Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of     complete unilateral cleftlip repair by modified millard cheiloplasty   "
18232|NCT03046888|"     Prospectively randomized study in patients with renal pelvic stones who are candidate to     standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly     allocated into two groups, 20 patients in each group. Group A will be scheduled to receive     routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.   "
18186|NCT03047486|"     The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin     pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which     allows the continuous measure of interstitial glucose rate. The results are available in real     time to the user, who can so use them to optimize the adjustment of its treatment by insulin     pump. Since a few years, several research programs aim for finalizing an automated system     using the data of real time interstitial glucose to adjust automatically, via an algorithm,     the release of insulin by the pump. This type of closed-loop system is for the moment only     experimental, not still widely available in routine. On the other hand, rudimentary     regulation systems partially automated already exist and can be used in common clinical     practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the     hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer     which interrupts the basal output when the algorithm embarked on the pump determines thanks     to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this     system to reduce hypoglycemias was proved by several studies in pediatric and adult     populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci     Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data     concerning the method of use of this system (sensor et pump initial configuration; patient     education), nor the evolution of the sensor and pump parameters during the use.      The aim of this observationnelle study is to collect the data of efficiency, safety and use     of the system Smartguard ® in common clinical practice in an adult population of subjects     DT1.   "
18187|NCT03047473|"     This is a safety and tolerability study looking at the addition of avelumab, an immune     checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with     newly diagnosed glioblastoma multiforme.      All patients will be receiving active therapy. Patients will begin the avelumab within 3     weeks of finishing their radiotherapy. Avelumab will be given at a dose of 10mg/kg IV every 2     weeks concomitantly with the monthly temozolomide. Avelumab will be continued for a total of     52 weeks.   "
18188|NCT03047460|"     The establishment of a biomarker(s) that can predict a clinical response to therapy over the     course of a 1-2 year clinical trial is critical for the expeditious development of treatments     for Multiple Sclerosis (MS). Identification of this biomarker would enable shorter and     smaller clinical trials resulting in the faster development of much needed treatments for MS,     specifically neuro-reparative therapies. The etiology of disease progression is conduction     block, demyelination and axonal degeneration. Evoked potentials provide a direct assessment     of the underlying etiologies of disease progression in MS. They are a functional assessment     of multiple pathways, including visual, motor and sensory, evaluating the integrity of myelin     and axons.      The variability of motor evoked potentials (MEP) measures has limited multimodal evoked     potential (mmEP) use in international, multicenter clinical trials. MEP evaluation does     significantly contribute to the predictive value of mmEP's. Recent advances in technology and     establishment of standardized protocols for MEP reduces the variability associated with this     procedure. The objective of this study is to evaluate the reliability and feasibility of MEP     and SSEP in an international, multicenter trial so that mmEP can be further evaluated as a     biomarker for disease progression. The rationale for this study is to explore the feasibility     and reliability of MEP's and somatosensory evoked potentials (SSEP's) in a multicenter     clinical trial for potential use as a biomarker that can predict clinical     progression/improvement in international clinical trials evaluating remyelinating therapies.      Study Objectives and Endpoints:      Objective:      The primary objective of the study is to evaluate the feasibility and test-retest reliability     of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with     MS.      Endpoints:      The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the     following evoked potential parameters      Motor Evoked parameters that will be measured:        -  MEP latency        -  Central motor conduction time (CMCT) root latency methods        -  MEP amplitude        -  MEP amplitude to compound motor amplitude ratio (MEP-M ratio) for the right and left          abductor digiti minimi (ADM) and the right and left tibialis anterior (TA)        -  Somatosensory evoked potential parameters will include Evoked potential latencies for          both upper and lower limbs bilaterally.      Study Design:      This multinational, multicenter study will be conducted in healthy adult volunteers and MS     patients to establish the feasibility and reliability of mmEP's. A total of 40 subjects, 10     (5 healthy and 5 MS) from each of the 4 sites will be enrolled.      The study will consist of two visits, 1-30 days apart, during which subjects will be screened     to confirm eligibility and will complete all specified study assessments.      Study Locations:      Canada, Germany, Switzerland and Italy, with 1 site in each country.      Number of Planned Subjects:      A minimum of 40 subjects are planned for this study. Subjects who withdraw from the study     prior to completion of the second visit may be replaced at the discretion of the     investigator.      Study Population:      This study will be conducted in subjects 25 to 58 years of age, inclusive, who are either     healthy volunteers (HV) or have been diagnosed with clinically definite MS who have a     detectable lesion by MEP or SSEP.      Study Groups:      Two groups, healthy volunteers and clinically definite MS will be included.      Duration of Study Participation:      Study duration for each subject will be two visits, the second visit schedule >24 hours-30     days from the first visit      Criteria for Evaluation:      Key Study Assessments:      Electrophysiological. MEP's and SSEPs will be measured in both upper and lower limbs     bilaterally. All studies will be read locally and reviewed by a blinded reader at another     center. The ICC of every measured evoked potential parameter will be determined on both the     central and local reads.   "
18189|NCT03047447|"     Original research article entitled Induced and Controlled Dietary Ketosis as a Regulator of     Obesity and Metabolic Syndrome by Madeline Gibas for consideration for publication in a     clinical journal. This research manuscript builds on previous landmark studies that report     that major weight and fat mass loss in type II (T2D) patients who were fed a very low     carbohydrate, ketogenic diet. In this manuscript, the investigators outline our research     study that showed statistically significant (p < 0.05) changes over time in hemoglobin A1c,     weight, BMI, body fat percentage and ketones for patients with metabolic syndrome who were     fed a very low carbohydrate diet, ketogenic diet.   "
18190|NCT03047434|"     2.1Purpose: The purpose of this study is to describe the chronology of postoperative pain in     patients undergoing shoulder, knee, ankle arthroscopy. Further, within this population the     predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for     persistent post surgical pain.      2.2 Research Design: This is a prospective descriptive correlational design looking to     characterize postoperative pain variables across various procedures that historically have     significant levels of persistent post-surgical pain. Further, bivariate correlations at     different time points will be examined to see how DVPRS along with Pain Assessment Screening     Tool and Outcomes Registry (PASTOR) correlates with other measures.      2.3 Methodology/Technical Approach A total goal of 250 participants will be queried regarding     their postoperative pain experience following shoulder arthroscopy and knee arthroscopy.     Descriptive multidimensional tools (the DVPRS and the electronic Pain Assessment Screening     Tool and Outcomes Registry (PASTOR)) will be used preoperative either during their     preoperative surgical visit or the day of surgery and extending to 6 months postoperatively.     As these tools have been utilized in previous studies for the prediction of persistent post     surgical pain, the DVPRS will additionally be evaluated for its predictive validity as it is     a short, easy-to-administer, bedside tool.   "
18191|NCT03047421|"     DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea).      One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study     is to compare the influence of different methods of neck circumference measurement in the     accuracy of DES-OSA and P-SAP scores to detect OSA.   "
18203|NCT03047265|"     This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent     Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally     Advanced Nasopharyngeal Carcinoma   "
18242|NCT03046758|"     The objective of this trial is to evaluate the safety of the intraperitoneal administration     of the combination of fosfomycin, metronidazole, and granulocyte-macrophage     colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated     appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of     fosfomycin and metronidazole after intraperitoneal administration.   "
18414|NCT03044522|"     This multicenter randomized (block randomization) controlled parallel arm pilot study     comparing the incorporation vs no incorporation of a Nurse Pain Educator into clinics that     treat chronic non cancer pain patients with opioid analgesics. Subjects who are either opioid     naïve or opioid experienced will be enrolled into the study.   "
18214|NCT03047122|"     Mammography is considered the standard imaging method for breast cancer screening, and is     known to result in reduced mortality from breast cancer. However, the diagnostic yield of     mammography depends particularly on breast tissue density, with sensitivity as low as 30-48%     in dense-breast women. Ultrasound is an attractive adjunct imaging method to mammography as     it is widely accessible, relatively inexpensive and well-tolerated by patients. The addition     of hand-held ultrasound to mammography has been demonstrated to significantly increase breast     cancer detection in women with dense breasts. It is however dependent on the expertise and     skill of the operator.      In recent years, the FDA has approved the use of the automated breast ultrasound (ABUS) for     use in screening of women with dense breast. Unlike handheld ultrasound, the ABUS is     relatively simple to use, necessitating less technical training, and results in higher     reproducibility.      The research aim is to evaluation of automated breast ultrasound (ABUS) regarding the     detection and classification of breast lesions, compared to hand-held ultrasound, according     to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS)     classification. The investigator will also evaluate parameters regarding patients' comfort,     workflow, and duration of image interpretation.   "
18192|NCT03047408|"     About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a     parasomnia characterized by partial or complete loss of REM sleep muscle atonia and     dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is     the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis.      RBD in PD is believed to be a marker of a more widespread degenerative process and a marker     of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired     in both motor and non-motor domains, compared to those without RBD, with an increased risk of     dementia. However, little is know about the relationship between the evolution of RBD, clinic     and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD     symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in     PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal     vPSG study has been performed in PD-RBD population.      Thus, the main objective of this study is to longitudinally evaluate clinical and     video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in     patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain     whether RBD features remain stable over time. The possible remission of RBD with the     progression of PD would question indeed its reliability as prognostic bio-marker.   "
18193|NCT03047395|"     The purpose of this study is to investigate the long-term safety and efficacy of risankizumab     in the treatment of moderate to severe chronic plaque psoriasis.   "
18194|NCT03047382|"     Around a third of patients who develop acute kidney injury (AKI) do so after a hospital     admission (hospital-acquired - HA-AKI).      The primary aim of the study is to prospectively test whether introducing a complex     intervention (a 'care package' - comprising a clinical prediction rule incorporating an     electronic alert which generates a checklist for patient management to relevant health     professionals) can identify patients on admission to hospital who are at risk of developing     HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to     be put in place.      The investigators will introduce the care package in one acute hospital and evaluate its     effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a     sister hospital within the same Trust (which will act as a control site). The investigators     will extend evaluation for a further ten months to assess sustainability on the first site     and introduce the package at the control hospital to assess generalisability. The primary aim     is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI,     management of patients already with AKI on admission to hospital (whose care may also benefit     from the checklist) and a cost-effectiveness analysis.   "
18195|NCT03047369|"     This is an observational designed to:        -  Aim 1: Define novel homogeneous groups of patients with unclassified leukodystrophy and          work toward finding the cause of these disorders;        -  Aim 2: Assess the validity and utility of next-generation sequencing in the diagnosis of          leukodystrophies;        -  Aim 3: Establish disease mechanisms in selected known leukodystrophies;        -  Aim 4: Track current care and natural history of these patients to define the          longitudinal course and determinants of outcomes in these disorders.      These objectives will be achieved by collecting, and subsequently analyzing, data and samples     in a longitudinal fashion across leukodystrophies.   "
18196|NCT03047356|"     A trial that tests whether implementation intentions improve sleep among adoelescents.   "
18197|NCT03047343|"     Pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment     to newborns suffering from congenital heart defects, characterized by an increase in blood     flow and pulmonary blood pressure.      The intervention consists of placing a band around the pulmonary artery. This band causes an     artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. It     acts as a first step, preparing the ground for a future definitive repair intervention.      It is mainly used in the context of septal defects, atrio-ventricular canal defects or     uni-ventricular hearts.      The complications linked to strapping include, among others, the erosion of the band in the     artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary valvular     insufficiency, the obstruction of the coronary artery and an ineffective strapping.      The early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and     13.6%, while strapping readjustment rates oscillate around 20%. It is assumed that the     mortality is linked to the nature of the cardial malformation (uni-ventricular or     bi-ventricular) rather than the procedure itself.      This retrospective study aims to evaluate the intra-hospital and extra-hospital mortality     rate of pulmonary artery strapping, as well as the readjustment rate within two groups of     patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting     from a bi-ventricular cardiac reparation. The aim is to determine the short term mortality     rate of the intervention and the incidence of complications within the hospital, within the     two groups.   "
18198|NCT03047330|"     This study aims to investigate the impact of menopause-related sleep fragmentation on     metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep     fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat     gain.   "
18199|NCT03047317|"     This is an open label study of MABp1 in six healthy volunteers. Participants will receive a     single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling     for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr,     1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In     addition to pharmacokinetic data, participants will be monitored for the development of     treatment emergent adverse events.   "
18200|NCT03047304|"     Magnesium is a known treatment for neuroprotection in preterm labor before 32 week of     gestation. High concentration of Magnesium in the blood stream known as cause of conduction     abnormalities and ECG changes such us prolonged QT, QRS and PR in about. The goal of our work     is to evaluate the PR intervals in embryos after maternal treatment with magnesium during     preterm labor.   "
18201|NCT03047291|"     Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus     reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or     periimplantitis, as a coadjuvant treatment of mechanical therapy.   "
20595|NCT03015974|"     This study tries to identify the safe and effective treatment option for IgA nephropathy in     children. Investigators will perform prospective registration study among 25 pediatric     nephrology medical centers in China.   "
18204|NCT03047252|"     The study was designed to evaluate the effectiveness of a novel kinematic biofeedback system     - SWORD Phoenix- in the rehabilitation after total knee replacement .      SWORD Phoenix allows the patients to perform independent rehabilitation sessions at home,     under remote monitoring from the clinical team.      The investigators hypothesize that the clinical outcomes of a home-based rehabilitation     program will be at least similar to the outcomes of a traditional home-based rehabilitation     with face-to-face sessions.      This is a randomized controlled trial with active comparator. Patients will be enrolled and     randomized pre-operatively into 2 groups: intervention group and control group. Both groups     will perform 8 weeks of rehabilitation starting on day 7 after surgery.      The intervention group will perform daily rehabilitation sessions at home using SWORD     Phoenix, under remote monitoring from a physical therapist. The control group will perform 1h     rehabilitation sessions 3 times a week, at home, given by a physical therapist.      Outcomes will be measured at weeks 4 and 8. The primary outcome is the performance in the     Timed-up-and-Go (TUG) test between in each patient in comparison with the pre-operative     score. Secondary outcomes will be measured in term of: a) range of motion of the knee joint     (flexion/extension); b) Knee Osteoarthritis Outcome Score); c) quality of life, as measured     by the SF-36 scale.   "
18205|NCT03047239|"     Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural     vision tests measured prospectively every 3 months over a 2-year period, will be used to     model TF's ability to serve as a risk factor for individual progression rates.   "
18206|NCT03047226|"     The purpose of this study is to determine the proportion of patients diagnosed with Lynch     syndrome in colorectal cancer patients with the loss of staining by immunohistochemistry     (IHC) of any of the mismatch repair (MMR) proteins. Besides, this study aims to test the     specificity and the sensitivity of detecting microsatellite instability (MSI) by     next-generation sequencing, and to find out the consistency between IHC and MSI in colorectal     cancer patients in China. In addition, researchers want to analyze the clinical     characteristics and germline mutation of Lynch syndrome in Chinese population.   "
18207|NCT03047213|"     This pilot phase II trial studies how well sapanisertib works in treating patients with     bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally     advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and/or TSC2     mutations (changes in deoxyribonucleic acid [DNA]). Sapanisertib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
18208|NCT03047200|"     The purpose of this study is to further test islet cell transplant in patients who have had a     kidney transplant. This study will also evaluate the safety and effectiveness of the     anti-rejection medications used to prevent rejection after your islet cell transplant.   "
18209|NCT03047187|"     Objectives:        1. To examine the ability of ACLR patients at discharge from rehabilitation to perform a          single-hop for distance.        2. To examine isometric muscle strength of ACLR patients at discharge from rehabilitation.        3. To examine ACLR patients' self-reported knee function at discharge from rehabilitation        4. To assess the psychological factors for ACLR patients at discharge from rehabilitation.        5. To correlate single-hop for distance with self-reported knee function, strength and          psychological factors for ACLR patients at discharge from rehabilitation to discover          whether any of these factors can predict the others.   "
18210|NCT03047174|"     The aim for the present study named RAREST (RAdiotherapy RElated Skin Toxicity) is to compare     the new dressing with the standard skin care. 168 patients receiving radiotherapy alone or     radiochemotherapy for locally advanced head-and-neck cancer will be included. The primary aim     is to investigate the rate of patients experiencing severe, stressful radiation dermatitis.     The skin status will daily be inspected and assessed by specially trained doctors and nursing     staff.      It is expected that the new self-adhesive dressing is superior to standard care with respect     to prevention of grade ≥2 radiation dermatitis in patients receiving radiotherapy or     radio(chemo)therapy for a head-and-neck tumor. Thus, the dressing would be well qualified to     become a new standard procedure at the skin care of patients with a head-neck tumor.   "
18211|NCT03047161|"     Fetal research and clinical practice has been hampered by a lack of suitable investigational     techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy     and physiology, but it has significant limitations for assessment of cardiac rhythm. The     proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a     new tool for the study of normal and abnormal fetal heart rate and rhythm.   "
18212|NCT03047148|"     Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory     and hemodynamic parameters as well as subjective signs of well-being such as absence of     nausea, vomiting and a low pain level. This investigation intends to compare the rate of     postoperative complications in the 2 groups from pair matched patient records after regional     anesthesia with otherwise similar patients after general anesthesia.   "
18213|NCT03047135|"     Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate     cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA     response, and every patient with a radiographic response also had a PSA5 response.      Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing     promise in these initial studies, reserving its use for end-stage patients may not be the     optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in     roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional     regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease     states for prostate cancer.   "
18239|NCT03046797|"     In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly     obese patients is maintained through the ventilator, will be studied. Researchers suggest     that the technique will allow more time for intubation trial rather than conventional     techniques of intubation without ventilation. the Primary outcome will be the decrease of     desaturation events during intubation. Secondary variables will include; stress response to     intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful     intubation, the time required to intubation and operator satisfaction.   "
18240|NCT03046784|"     This prospective and observational trial over 55 pregnant women (third trimester) compares     non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic   "
18215|NCT03047109|"     Spinal anesthesia is widely used as the procedure of choice for cesarean delivery. In     comparison to epidural anesthesia it is faster, easier to perform, patients are more     comfortable, complication rates are lower, and it is more cost effective. Spinal anesthesia     is an accepted technique in elective cesarean sections. However, hypotension, resulted from     sympathectomy is a common problem, especially in pregnant women.      Spinal block causes peripheral vasodilation and venous pooling, which may result in maternal     hypotension. Maternal hypotension after spinal anesthesia for cesarean delivery, without     prophylactic measures, has a very high incidence (80%-100%). Even though highly investigated,     spinal induced hypotension remains a major concern, and it has been referred to as the Holy     Grail of obstetric anesthesia. The detrimental effects of the spinal induced hypotension are     maternal and fetal. Maternal effects are nausea, vomiting and dizziness. Hypotension results     in reduced uterine and intervillous blood flow with potential fetal hypoxia and acidosis.      Treatment and prevention of hypotension has been the subject of much investigation and     controversy. Prophylactic measures include: 1) left lateral tilt, 2) fluid preload, 3)     vasopressors,4) low dose spinal anesthesia. A 15° left lateral tilt is used routinely during     cesarean section, to prevent aorto-caval compression, however it is not sufficient as a sole     method. Left uterine displacement is achieved by tilting the operating table or by placing a     wedge under the woman's hip. Aorto-caval compression also may increase the spread of spinal     anesthesia. Among the non-pharmacological interventions studied to minimize the incidence of     hypotension sitting the patient up for up to 7 min after CSE anesthesia for cesarean section     reduced intraoperative ephedrine requirement without affecting the success of the spinal     anesthetic. In contrast, sitting up for 9 min resulted in the need for rescue epidural     anesthesia without additional benefit.      Phenylephrine Treatment of vascular failure in shock, shock-like states, drug-induced     hypotension or hypersensitivity; correction of paroxysmal supraventricular tachycardia;     prolongation of spinal anesthesia; vasoconstriction in regional analgesia; maintenance of     adequate level of BP during spinal and inhalation anesthesia. It has a number of important     attributes for treating spinal hypotension: (i) as an alpha-adrenergic agonist, its mechanism     of action directly addresses the decrease in systemic vascular resistance following spinal     anesthesia;(ii) phenylephrine has a faster onset of action compared with ephedrine; (iii)     ephedrine is associated with a ﬁve-fold increased risk of fetal acidosis; and (iv) ephedrine     is more likely to cross the placenta and increase concentrations of lactate, glucose, and     catecholamines in the fetal circulation compared with phenylephrine. However, phenylephrine     used alone may be accompanied by maternal bradycardia and does not beneﬁt from widespread     clinical experience, as does ephedrine do. Thus, phenylephrine has not yet become popular,     particularly for prophylactic use. Clinical experience suggests that phenylephrine may be     useful in addition to ephedrine when the latter fails to correct hypotension.      Ephedrine sulphate is a potent sympathomimetic that stimulates both α and β receptors and has     clinical uses related to both actions. Its peripheral actions, which it owes in part to the     release of norepinephrine, simulate responses that are obtained when adrenergic nerves are     stimulated. These include an increase in blood pressure, stimulation of heart muscle,     constriction of arterioles.   "
18220|NCT03047044|"     The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use     additional analgesics as well as a patient controlled analgesia (PCA). The most common pain     control method of this surgery is the intravenous (IV) PCA. but, if it is relatively     insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce     the pain intensity effectively. Consequently, it may result in the a lot of rescue analgesics     requirement, which leads to the adverse effects in patients who are very sensitive to     narcotic analgesics. In addition, the patient's satisfaction to the PCA may be low compared     with that of expected. For the recently released PCA instrument 'PAINSTOP', the investigators     can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus     dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion     (B.I), which is a new mode, so that the administered rate and amount of drug can be increased     or decreased according to the patient's use of bolus button. Therefore, this PCA device can     be implemented to the conventional mode, and added the function of automatically controlling     the basal rate and administered amount of drug according to the use demand of the patient.     However, since there are few studies related to this new mode of PCA, more research is needed     in patients with postoperative pain.   "
18221|NCT03047031|"     This is an active surveillance study to monitor the real world safety of nintedanib in Indian     patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in     clinical trials. Since only 20 patients from India were enrolled in the INPULSIS trials, the     safety data on Indian patients is limited. In this active surveillance, the safety of     nintedanib in IPF patients will be examined in Indian real world setting   "
18222|NCT03047018|"     The purpose of this study is to determine if a program can help children with autism who are     overweight. Specifically, this study will look to see if changes in a child's eating habits     and exercise can help with weight loss. Investigators also want to see how parents feel about     the program and if they will complete the entire program.      Twenty children with autism spectrum disorder (ASD) who are also overweight will participate     in this study at the Marcus Autism Center. All children who enroll will receive the The     Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE)     program. This involves 16 sessions over six months. After the six months, participants will     come back every month for three months for a follow up visit. Therefore the study will last a     total of nine months.      An optional sub-study will also be conducted where participants will provide stool samples in     order to assess their gut microbiome. Participation in this study is optional and will in no     way affect participation in the primary study.   "
18223|NCT03047005|"     This study will test the effectiveness and relative efficacy of naltrexone/bupropion     medication as a maintenance therapy for the treatment of binge eating disorder (BED) in     patients with obesity. This is a controlled test of whether, amongst responders to acute     treatments, naltrexone/bupropion medication results in superior maintenance and longer-term     outcomes compared with placebo.   "
18224|NCT03046992|"     YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase     inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing     wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain     metastasis due to good blood brain barrier (BBB) penetration property as well as for the     treatment of primary lung lesion and extracranial lesions. This study will be conducted to     evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic     NSCLC patients with EGFR mutations.   "
18225|NCT03046979|"     The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with     advanced HCC.   "
18226|NCT03046966|"     This study evaluates a new approach to the instruction of pediatric residents in the skill of     neonatal intubation. Half of the participants will receive focused simulation training and     cognitive instruction while the other half will not. The collected data from both groups will     be compared.   "
18227|NCT03046953|"     The AVAIL-T trial is a trial to find out how effective avelumab is at treating patients with     primary T-cell lymphoma that is refratory to or has relapsed following initial treatment.   "
18228|NCT03046940|"     The experiment aims at investigating whether the doctor-patient communication has an     influence on patients' willingness to take medication. Patients' attitude towards the     medication is manipulated via a critical film sequence. Afterwards patients of the two     experimental groups have a communication with one of the investigators of the study. Patients     are told that the investigator is a medical doctor. The doctors either communicate in a     patient-centered or doctor-centered style with the patient. Patients in the control group do     not have the possibility to talk to a medical doctor. Afterwards patients are offered the     aforementioned pill that is supposed to be a cognitive enhancer (actually placebo pill). Pill     intake is voluntary. The investigators hypothesize that patients in the experimental group     with the patient-centered style of communication are more likely to take the pill than     patients in the experimental group with the doctor-centered style of communication or     patients in the control group.   "
18230|NCT03046914|"     Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition.     Previous reports have reported that HLA-B*5801 is an important genetic risk factor     significantly associated with the development of allopurinol-induced SCAR. However, there has     been no prospective study to prove the clinical efficacy of a HLA-B*5801 screening before     administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this     prospective study is to test our hypothesis that a pre-screening of HLA-B*5801 will     significantly reduce the risk of allopurinol-induced SCAR development compared to the     historical control.   "
18231|NCT03046901|"     The purpose of the study is to investigate the safety and efficacy of oral vancomycin in     patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation. The     primary endpoint is looking at the effect of the drug on liver function tests, an important     surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints include a     decrease in liver function tests at 1 year, changes in bilirubin and adverse events.     Effective treatment at the onset of PSC recurrence may lead to decreases in disease     progression, recurrent liver failure, and repeat liver transplantation.   "
21242|NCT03007537|"     To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney     injury, and trying to provide evidence for protecting the renal function and improving the     prognosis for patients after cardiac surgery.   "
18233|NCT03046875|"     To determine the biophysical impact of biophysical Impact of Transcutaneous Spinal Cord     Stimulation (TSCS) within a single session. We hypothesize that subjects will demonstrate     increased volitional muscle strength with TSCS. This will be assessed by isokinetic strength     testing of post-injury dominant-side knee extension. Subjects will be tested in both     Transcutaneous Spinal Cord Stimulation and sham conditions.   "
18234|NCT03046862|"     <Research Hypothesis> The dynamics of immune systems by cytotoxic chemotherapy and its     changes by combination with immuno-oncology agents will be uncovered.      The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is     feasible and efficacious in chemo-naïve biliary tract cancer.      <Purpose of the study> To assess the effect of Durvalumab/Tremelimumab in combination with     gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer     patients.   "
18235|NCT03046849|"     The purpose of this study is to find out the proportion of patients diagnosed with Lynch     syndrome in colorectal cacner patients meeting Chinese Lynch syndrome criteria. Besides, this     study is aimed to analyze the clinical characteristics and germline mutation of Lynch     syndrome in Chinese population.   "
18236|NCT03046836|"     Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There     are significant health and economic burdens associated with AUD and co-occurring IPA, and     little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate     both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is     scant. The proposed study is designed to address these gaps in the literature by utilizing a     human laboratory paradigm to test the effects of oxytocin on craving and aggression among     couples with AUD and co-occurring IPA.   "
18237|NCT03046823|"     The study aims to:        1. Characterize coronary artery disease (CAD) using CT Angiography (CTA) and scaling power          law in 100 patients with obesity        2. Characterize cardiac remodeling using curvedness-based MRI in 100 patients with obesity        3. Compare the differences of cardiac and vascular remodeling in patients with metabolic          syndrome and those without   "
18238|NCT03046810|"     Incontinence and the skin irritation (dermatitis) associated with it are common problems.     Treatment of dermatitis is effective, but requires effective cleaning and application of a     barrier substance to prevent further contact between urine or feces and the skin. Water based     cleansing with the addition of a pH balanced cleanser is more effective than standard     abrasive cleansing with paper or a cloth, and is better tolerated by those with skin     irritation. Zinc oxide based barriers effectively promote healing and prevent further skin     damage. Spray forms are less cumbersome and generally preferred, but are difficult to for the     patient to apply independently given the challenge of accessing the perineum.      40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center     will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each     use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks     1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will     be measured using a visual analog scale derived from the quality of life in incontinence     scale.      The investigators hypothesize that the device will 1) effectively treat incontinence     associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.   "
18241|NCT03046771|"     Hypothesis: 'Transport PLUS,' a low cost, easily generalizable intervention performed by     Emergency Medical Technicians while transporting a patient home from the hospital, can     improve transitions of care and improve patient safety following hospitalization as measured     by decreased rates of falls and reduced rates of return to the hospital.   "
18243|NCT03046745|"     This study is a multi-center, prospective cohort study which are planned to enroll the 6000     patients who diagnosed the primary gastric cancer and 12,000 healthy normal cohort     participants for 5 years. All participants who enrolled in this registry, the participants     were questioned by the gastric cancer survey and the serum and tissue of these participants     were analyzed.      The main aim of this study is        1. To evaluate the optimal interval of endoscopic screening for early detection of gastric          cancer and risk factors in Korean.        2. To evaluate the diagnostic validity of serum biomarker (combining pepsinogen, H pylori          IgG Antibody, and TFF3) as a screening test for detection of GC in Korean.   "
18244|NCT03046732|"     Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in     order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT     has been associated with better quality of life (QOL) [1-3], reduced morbidity and     mortality[4, 5], and reduced healthcare costs[6]. Studies in the US have shown that patients     receiving tailored transplant education were more likely to complete the transplant     evaluation [9, 14, 15]. For instance, patients receiving the Explore Transplant (ET)     education program designed by Dr. Waterman, were more knowledgeable about KT and more likely     to complete KT evaluation than control patients. Currently, there is a lack of standardized     KT education in Ontario. Traditional approaches have been insufficient in providing the     necessary education and information to enable patients to make an informed decision about     their care. To address this issue, the study will assess the impact of kidney transplant     related education using the Explore Transplant Ontario (ETO) education program on kidney     transplant-related knowledge and on readiness to consider KT, readiness to consider living     donor KT, and wait list/referral rates in patients undergoing maintenance hemodialysis.      In order to comprehensively measure this impact, 5 variables will be explored.        1. Readiness to consider DDKT        2. Readiness to consider LDKT        3. KT related knowledge in patients        4. Proportion of patients waitlisted or undergoing KT workup at 6 and 12 months after          administration of ETO        5. Proportion of patients who have identified at least one potential living donor at 6 and          12 months after administration of ETO      The hypotheses are as follows:        1. Readiness to consider DDKT will be higher in the intervention group compared to the          control group at follow up.        2. Readiness to consider LDKT will be higher in the intervention group compared to the          control group at follow up.        3. The KT related knowledge of the patients will be higher in the intervention group          compared to the control group at follow up.        4. The proportion of patients waitlisted or undergoing KT workup at 6 and 12 month after          the KT education will be higher in the intervention group compared to the control          group.        5. The proportion of patients who have at least one potential living donor at 6 and 12          month after the KT education will be higher in the intervention group compared to the          control group.   "
18245|NCT03046719|"     The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative     analgesia in intravitreal silicone evacutaion surgery   "
18246|NCT03046706|"     The accepted recommendation after removal of vocal cord lesion is voice rest.This     recommendation leads to great tension among the patients, loss of working days and need to     practice speech therapy.The investigators hypothesize that voice rest after surgery does not     affect the quality of the patient's voice. The investigators will divide the patients into 2     groups: the first group will be instructed for a postoperative voice rest and the second     group will not. Later the investigators will compare the results and conclude whether voice     rest had any significance.   "
18247|NCT03046693|"     Clinical trial.gov      Brief summary :      Non-arteritic anterior ischemic optic neuropathy (NAION) is an optic neuropathy due to acute     or subacute ischemic event of anterior optic nerve axons retrolaminar part that was     vascularized by posterior ciliary brevis artery. The incidence of ischemia will be followed     by axonal edema and causing compartment syndrome and heighten the incidence of ischemic.      In NAION, the main pathology occurs at the level of the optical nerve, the axons of retinal     ganglion cells. Initial damage is on the optic disc ischemia resulting hypoxic injury of     axons and manifest as disc edema. Axonal edema cause disturbances of retrograde axonal     transport of neurotrophic factors, especially brain derived neurotrophic factor, to the     retinal ganglion cells. This will trigger a secondary toxicity and apoptosis. In addition,     the presence of oxidative stress, calcium influx and mitochondrial damage will also triggers     apoptosis. After the apoptosis of retinal ganglion cells, there was a thinning of the retinal     nerve fiber layer (RNFL) through Wallerian degeneration. Thinning of the RNFL will manifest     as visual field defects and the decline in visual acuity in patients with chronic phase     NAION.      Though NAION include disease entity that has long existed, but until now, there has been no     evidence-based study on medical or surgical procedures that is effective enough to overcome     NAION. The main treatment is to manage the risk factor such as hypertension, dyslipidemia,     diabetes mellitus, hypercoagulable state. In general, if the patient is in the acute phase     (edema of optic nerve head), methylprednisolone administration may be considered, but if the     patient is already on chronic phase (atrophy disc) which generally occurs 6-11 weeks after     the onset, then steroids are no longer indicated. Neuroprotective agent was considered as     treatment in NAION given primary pathology NAION is the retinal ganglion cell axons. Among     the various neuroprotective substance, Citidine diphosphocoline (CDP-choline     5'-diphosphocholine or Citicoline) is a therapeutic option NAION.      Citicoline is an endogenous mononucleotide consisting of ribose, cytosine, pyrophosphate, and     choline. Citicoline is a component intermediates in the synthesis of phospholipids in cell     membranes, ie phosphatidylcholine. Exogenous citicoline administered orally or intravenously,     will be split into citidine and choline. Citicoline via oral administration can be absorbed     completely and have a similar bioavailability in the blood compared to parenteral     administration such as intravenous. Once absorbed, citicoline will be distributed throughout     the body and enter the blood-brain barrier and the blood retinal barrier penetrate into the     central nervous system. If there is damage to neurons, exogenous citicoline will participate     in the synthesis of phospholipids in the neuronal cell membrane. Some studies show that     citicoline may have a neuroprotective effect on retinal ganglion cells and supporting     regeneration of damaged neurons in vitro. Previous research on the citicoline effect in     chronic phase NAION give satisfactory results. Dopaminergic neurotransmitter systems known to     occur in vast numbers in the retina and post-retinal visual pathway. Retinal ganglion cells     using certain subtypes of dopamine as a means of communication with the visual cortex. Rejdak     et al in animal models showed that citicoline administration could improve and strengthen the     dopamine transmission in the retina. Citicoline also a safe medicine, without serious adverse     effect.      Electroretinogram (ERG) is a tool to measure the function of the retina. ERG examination can     measure electrical changes in the retina after light stimulus. ERG examination that can     detect changes in the activity of retinal ganglion cell is a pattern ERG. Spectral-domain     optical coherence tomography is a tool that can measure the thickness of retinal ganglion     cells.      Thinning of the RNFL will manifest as visual field defects in patients with NAION. The     typical visual field defects of NAION is altitudinal defects associated with segmental edema     optic nerve head.      Based on these descriptions question arises whether the citicoline supplementation can repair     damage to the neurons of the retina, especially the retinal ganglion cells, in NAION     resulting in improved retinal function which can be judged from the improvement of the value     of the amplitude of the wave of P50 and N95 in the examination pattern ERG (PERG) when     compared with placebo ? In addition whether citicoline supplementation can increase the     thickness of retinal ganglion cells assessed using SD-OCT? Does citicoline supplementation     give the effect of improving visual field defects in patients with NAION?   "
18298|NCT03046030|"     The aim of this proposal is to investigate brain response and connectivity changes evoked by     video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy     and patient populations to elucidate the underlying brain mechanisms of mind-body     interaction, imagery, and acupuncture.   "
18248|NCT03046680|"     Hypertension is a multifactorial clinical condition, it may not cause symptoms and its     diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage     an adequate blood pressure.      There are several hypotheses for the non-control of blood pressure, among them the difficulty     of lifestyle change, irregular treatment with antihypertensive drugs, non-individualized     treatment. Studies haven shown that tools such as multiprofessional team and hypertension     leagues are important strategies to obtain a better outcome in the hypertension treatment,     but new approaches are still necessary. Health Coaching is an individualized form of     follow-up, promoting better adherence, better nutrition, smoking cessation, regular physical     exercise and regular use of drugs, thus reducing cardiovascular mortality.   "
18249|NCT03046667|"     The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both     genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of     daily intake β-glucans will be carried out with a beverage containing β-glucans and a control     beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley     has an effect on stomach and intestinal health, including stool volume and frequency.     Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate),     calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled     hydrogen and methane, before and after the intervention, subjective perception of     gastrointestinal problems and digestion as well as the participants' attitudes towards     functional foods are measured using Visual Analog Scale (VAS).      Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic     metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed   "
18250|NCT03046654|"     Cervical cerclage is an obstetric intervention used in women with poor obstetric histories.     After recruiting the participant, Trans vaginal sonography will be used to examine cervical     length and funneling. In addition vaginal examination will be performed to evaluate the     cervix. After placing the cerclage, the participant will be invited every 4 weeks for a     follow up evaluation session in order to examine the cervix and cerclage position. .   "
18251|NCT03046641|"     Duration of exercise is an important factor among the medical guides for weight loss.     However, there is still little knowledge about other its models in middle-aged and older men.     The present study aimed to determine the effects of the interval training on weight loss and     lipid profile, and to compare its efficiency with the continuous training.   "
18252|NCT03046628|"     The aim of this study is to test the feasibility of using polarised green laser and CMOS     camera in order to assess the tissue perfusion of lower extremity ulcers in patients     suffering from diabetic foot by comparing this method with the percutaneous tissue oxygen     tension examination which is currently the gold standard examination.   "
18253|NCT03046615|"     For procedures involving proximity to the nerves responsible for eye movement, the need to     monitor eye movement exists. The current solution is to place needles in the muscles     surrounding the eye. The Investigators have invented a non-invasive electrode and software     designed to monitor eye movements non-invasively. The electrode is placed on the skin on the     corner of the eye and using the natural dipole of the eye, detects the horizontal and     vertical movements of the eye. The Investigators would like to prove efficacy compared to the     standard monitoring.   "
18254|NCT03046602|"     The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for     parents.This anxiety could have repercussion on parents adaptation on their new environment,     on parent's role and also on their relaional interaction with the baby. As StJoseph hospital     receives an important number of premature babies, the neonatology service aim to evaluate the     real life experience of mothers during the transfer to set up improvement axes with hospital     departments upstream.   "
18255|NCT03046589|"     Primary Objectives:        1. To determine the safety and tolerability of single and multiple oral doses of DP13 in          healthy male subjects        2. To assess the pharmacodynamics of single and multiple ascending oral doses as well as          dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects      Secondary Objectives:        1. To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male          subjects        2. To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male          subjects   "
18256|NCT03046576|"     Increased plasma DPP4 activity (DPP4a) could predict both subclinical and new-onset     atherosclerosis, and our previous study has found that the DPP4a was significantly lower in     MI patients compared with patients having chest pain or unstable angina alone, and DPP4a is     associated with no-reflow and major bleeding events in STEMI patients during hospital stay.     As no-reflow phenomenon and major bleeding events independently associates with a worse     in-hospital and long-term prognosis. One may speculate that the DPP4a is associated with     long-term follow-up adverse cardiovascular events in these patients.The hypothesis was tested     in this study.   "
18257|NCT03046563|"     Experimental research design with two-group repeated-measure design. Experimental group was     pressing the Hegu (LI 4), Zusanli (ST 36) , Tianshu(ST 25) and abdominal massage for eight     minutes total, press once in the morning and afternoon, seven days total and two days for     follow the trail. Control group was pressing sham ponits. Research tools to self     semi-structured questionnaire collected data on patient's diet, activity, medication,     defecation patterns, subjective defecation feelingauscultation bowel sounds like.   "
18258|NCT03046550|"     This study evaluates the safety and pharmacokinetics of NTM-1634 in healthy subjects.   "
18259|NCT03046537|"     Detection of metabolic state of women with polycystic ovary using NA-Nose.   "
18260|NCT03046524|"     Objectives:        1. Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical          neoplasms        2. Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and          have a different impact on the health of the patients   "
18272|NCT03046368|"     Several studies indicate that a survey that adapts personalized design features achieves     higher participation rates. A feature can be a personalized cover letter which appears more     relevant and interesting for the sample member. In the spirit of adaptive design, this study     seeks to establish whether it can be advantageous for participation overall to use cover     letters with targeted content and whether the effect on participation of different versions     of the cover letter varies in sample subgroups in order to optimize design features in future     surveys.   "
18261|NCT03046511|"     An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis.     Catheter insertion has been associated with infectious complication such as Exit Site     Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the     technique because the need of catheter removal. Most of international guidelines recommends     the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous     single injection before the procedure. For the last 25 years our unit gives a single     intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this     study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure     intraperitoneal single dose administration of the same drug.   "
18262|NCT03046498|"     Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP)     into WellConnect.   "
18263|NCT03046485|"     120 Patients with visual acuity <6/12 will be randomized to receive either usual care or     participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. We     hypothesize that a structured self-management low-vision rehabilitation program provides a     greater improvement in participation in daily activities, and improves quality of life in     vision-impaired people compared to the provision of the usual low vision rehabilitation     services. We also plan to document barriers that prevent patients with low vision (visual     acuity <6/12) from participating in self-management course.   "
18264|NCT03046472|"     Background: Life time prevalence of Low Back Pain among Children and Adolescent ranges from     32% to 66%. This prevalence gets higher with age and among 17 years old it`s equal to     prevalence among adults. Previous episode of Low Back pain is a predicting risk factor to the     next one, hence we should do preventative care at a young age, even before the first attack     occur. Poor posture was found as one of the risk factors for Low Back Pain in children.     Adolescence with neutral posture had less prevalence of Low Back Pain then those with poor     posture. Prolong slouch sitting was associated with Low Back Pain. Prevention education     programs, focusing on knowledge, did not show effective change in posture behavior. Hence,     the researchers concluded that it`s better if they focus on exercise.      Research Goal: comparison between physical therapy treatment for good posture once a week     versus once a month, on postural behavior, thorax curve angle and Low Back Pain.      Research type: randomize, Interventional, blinded. Methods and Procedures Population: the     study will include 50 children and adolescents age 10-18 years suffering from poor back     posture, with or without Low Back Pain.      Procedure: The study will consist of two groups: both groups will get personal meeting once a     month and a program of exercising at home every day. Treatment group will have in addition     group meeting once a week and control group not. The intervention program will include     physical awareness and practice for good posture, and exercises for flexibility, strength and     muscle endurance.      Measurement tools:Digital Inclinometer for measuring thorax curve angle. Postural observation     for measuring postural habits. Back pain and postural habits questionnaire for measuring     postural knowledge and habits of participant, including demographic data. Parents'     questionnaire for measuring parents' knowledge and ideas.      Research hypothesis: postural behavior, thorax curve angle and Low Back Pain will get better     in both groups but more in the treatment group.   "
18265|NCT03046459|"     This is an open-label, single ascending dose study to characterize the safety and PK/PD     profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2     family.   "
18267|NCT03046433|"     This study is a multicenter and prospective cohort study of children diagnosed with asthma.     Clinical symptoms and signs, quality of life, blood test, and lung function were detected     every three months. FeNO detection, chest imaging, and induced sputum smear were detected     when necessary. Biological samples will be collected when recruiting and finishing follow-up.   "
18268|NCT03046420|"     This study is exploratory in nature and seeks to describe hypertension diagnosis and     management among patients in long-term care (LTC) facilities.      Specifically, the primary objective is to:      • Identify LTC patients who are diagnosed with hypertension and assess the management and     different outcomes of proper control of BP regarding to incidence of falls, cognitive     decline, kidney diseases, cardiovascular diseases and incidence of cerebrovascular accidents      The secondary objectives are to:      Describe treatment patterns of hypertension in LTC facilities        -  Identify patients who are receiving non-pharmacological treatment and effectiveness of          this modality of treatment.        -  Identify different classes of drugs used to treat hypertension in patients staying at          LTC facility        -  Identify different drug adverse effects encountered by patients receiving medical          treatment.        -  Identify patients who achieved normal blood pressure according to current guidelines   "
20610|NCT03015779|"     The aim of this trials investigates the therapeutic effects of application autologous oral     mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.   "
18270|NCT03046394|"     One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet     will be tried six times in random order by the patient. The patient will be an active     prosthetic foot user who walks several kilometers per day and was amputated at the     trans-tibial level because of injury. Gait pattern will be rated in comparison with the     patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the     patient. One-leg standing and 10-meter walking tests will also be performed.   "
18271|NCT03046381|"     Schnitzler's Syndrome (SchS) is a late-onset multifactorial autoinflammatory disease     characterized by chronic urticarial skin lesions and a monoclonal gammopathy usually     belonging to the immunoglobulin M (IgM) or IgG class. Symptoms associated with SchS are     recurrent fever attacks, bone and muscle pain, arthralgia or arthritis, fatigue and     lymphadenopathy. SchS is a rare disease with approximately 300 cases reported in the     literature. The nature of SchS is chronic without known reports about spontaneous remissions.     Disease onset occurs around the age of 50. About 15% of patients eventually develop a     lymphoproliferative disorder, most often Waldenström's macroglobulinemia. The pathogenesis of     SchS is still not well defined. Functional ex vivo studies showed excessive cytokine     production (IL-1ß, IL-6 and IL-18) of peripheral blood monocytes (PBMCs) in SchS as compared     to healthy controls. In addition to excessive IL-6 secretion from PBMCs IL-6 has repeatedly     been reported to be elevated in the serum of SchS patients too. As IL-6 plays a major role in     the development of multiple myeloma, IL-6 may also be associated with the formation of     lymphoproliferative disorders in SchS.      Until now, there is no approved standard therapy available for the treatment of SchS.     Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and other immunosuppressive     agents have been reported to provide variable relief from symptoms of bone pain and     arthralgia. Case reports and small studies about successful treatment of SchS with anti-IL-1     blockers (anakinra, rilonacept and canakinumab) accumulate. However, there have been complete     and partial treatment failures to anti-IL-1 blockade in SchS. In these patients, anti-IL-6     treatment (tocilizumab [TCZ]) demonstrated to be very effective in reducing the clinical     symptoms and inflammation markers in SchS. TCZ treatment has proved to be very effective,     well-tolerated and safe in other acquired autoinflammatory disorders, systemic juvenile     idiopathic arthritis (sJIA) and adult-onset Still's disease that share many clinical features     (rash, fever, joint involvement, lymphadenopathy, fatigue) and excessive cytokine production     with SchS. The study consists of a run-in baseline period of 1-4 weeks followed by an     open-label 20-week TCZ treatment phase with weekly s.c. injections (TCZ 162mg), followed by     an optional study extension up to a total of 1 year with ongoing once weekly TCZ 162mg     injections and a 4 week period of follow-up.   "
18273|NCT03046355|"     The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can     improve the baby's health at birth when compared with delivery at a later point in the     pregnancy.   "
18275|NCT03046329|"     The overarching objective of this study is to evaluate the symptom assessment and management     behaviors used by multiple myeloma (MM) providers for alignment with evidence-based     practices, and to explore changes in these symptom care behaviors from baseline to following     use of the Carevive Care Planning System (CPS). The overarching goal of the larger program of     research is to evaluate the impact of the platform on symptom assessment and management     strategies with individuals receiving treatment for multiple myeloma. The current study is     focused on determining feasibility of research methods and effect size finding so as to     gather the requisite data needed to design fully powered hypothesis testing studies.   "
18276|NCT03046316|"     This is an open randomized control clinical study, which aims to investigate the overall     benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who     do not progress after front line systemic therapy (chemotherapy or target therapy).   "
18277|NCT03046303|"     This study is a prospective, single-center, randomized controlled trial. The study protocol     was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is     combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with     advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group     and conventional pathway group . Inter-group differences were evaluated for clinical recovery     index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival,     etc.   "
18278|NCT03046290|"     The authors study the efficacy of the pudendal versus penile block for the relief of     postoperative pain in children receiving ambulatory circumcision.      In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited     during the anesthesia consultation will be allocated a general anesthesia with a pudendal     block (PUD group) or a penile block (PEN group).      Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).   "
18279|NCT03046277|"     Evaluation of acute kidney injury, renal recovery and development of chronic kidney disease     in patients undergoing lung transplantation   "
18280|NCT03046264|"     There is growing evidence that central blood pressure is a better predictor of hypertensive     end-organ damage and cardiovascular outcome than routine brachial readings.      The investigators aimed to evaluate the accuracy of a novel device for the non-invasive     determination of central blood pressure based on automated oscillometric radial pulse wave     analysis.   "
18281|NCT03046251|"     The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is     effective in preventing postpartum relapses.   "
18282|NCT03046238|"     To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs     block on post operative analgesia & stress response in patient undergoing modified radical     mastectomy.   "
18283|NCT03046225|"     Total knee arthroplasty (TKA) consists of a surgical replacement of this joint by a     prosthesis, and it is mainly carried out in cases of knee osteoarthrosis. In the     postoperative period of TKA, the pain is intense and limits the mobility of patients, so the     analgesia is one of the goals of the physical therapy. One of the alternatives available for     pain management is the transcutaneous electrical nerve stimulation (TENS), characterized by     the application of an electric pulsed current through electrodes positioned on the skin.     Therefore, the present study aims to evaluate the acute effects of TENS associated with     conventional physical therapy compared with conventional physical therapy on the pain level,     knee range of motion and administration of morphine in the rehabilitation of patients after     TKA.   "
18284|NCT03046212|"     Transcutaneous electrical nerve stimulation (TENS) is characterized by the application of an     electric pulsed current through electrodes positioned on the skin. It can be an alternative     for pain management after surgery for total hip arthroplasty (THA), since it is a safe and     cost-effective therapeutic tool, allowing the patient to move early due to pain relief.     Therefore, the study aims to evaluate the acute effects of TENS associated with standard     physical therapy compared with standard physical therapy on the intensity of pain, hip range     of motion and morphine consumption in the rehabilitation of patients after THA.   "
18285|NCT03046199|"     Chronic obstructive pulmonary disease (COPD) is a common chronic disease with a significant     medical and economic impact. Its prevalence is increasing and is estimated at 7.5% of people     over 40 in France. COPD is responsible for a significant impairment of quality of life and     was the 3rd leading cause of death in the world in 2010 when it was 4th place 20 years ago.      However, about 75% of patients with COPD are not diagnosed. Spirometry is the only     examination for the diagnosis of COPD. Patients identified at risk for COPD are     insufficiently using spirometry and general practitioners (GPs) underestimate the severity of     COPD when they do not practice spirometry in their patients. COPD is often diagnosed too     late, the disease being discovered at the stage of complications requiring hospitalization.     The underdiagnosis is mainly due to poor knowledge of patients, their difficulty in accessing     a specialist performing spirometry, their reluctance to perform spirometry, and the     insufficient involvement of general practitioners.      Currently in France, targeted screening for COPD and diagnosis in primary care is a major     challenge. The international (GOLD 2014) and French (HAS 2014) recommendations do not     indicate a systematic screening in the general population for COPD but advocate targeted     screening of patients by five questions to identify risk factors and symptoms of COPD. The     presence of at least one of these factors in an adult over the age of 40 requires spirometry.      Recent studies suggest the relevance of finding primary care variables for smoking and     respiratory symptoms in order to identify new cases of COPD.      However, the impact of the use of these questionnaires on the prevalence of diagnoses of COPD     in general practice has not been demonstrated. Moreover, the heterogeneity of the provision     of care according to the territories limits a fast or easy access (distance) to the     spirometry.      It is therefore necessary to evaluate in primary care the interest of a targeted screening of     COPD and the interest of a coordination of care for the realization of a spirometry, in order     to improve the rate of diagnosis of the disease.   "
18286|NCT03046186|"     After gastric sleeve patients undergo a substantial weight loss, but the physiological     mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone     secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however     to which extent is not fully established and furthermore, the mechanisms behind an altered     secretion are unclear. The purpose of this study is to investigate absorption and     postprandial metabolism of glucose and protein in addition to gut hormonal responses after     gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI.     Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI,     current BMI, sex and age will be included for comparison.   "
18287|NCT03046173|"     To investigate the effects of concentrated growth factors applied in maxillary sinus floor     elevation via a lateral window approach with simultaneous implant placement on repair of bone     defects and new bone formation.   "
19834|NCT03025945|"     Prospective, randomized, double-masked, placebo-controlled clinical study to define the     effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use     after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular     edema.   "
18288|NCT03046160|"     Background: Dyskinesia has been referred to as a major manifestation of affected muscle     performance and neuromuscular control of the scapular stabilizers. Alterations around the     scapula with muscular imbalances could facilitate or emphasize dysfunction in its surrounding     structures through compressive and shear stresses created by abnormal pull through     attachments. No studies have investigated the effect of scapular mobilization with movement     on neck mobility and pain. Objective: To quantify the effects of utilizing a scapular     mobilization with movement on cervical pain and range of motion as compared to conventional     treatment under the presence of scapular dyskinesia. Design: an experimental case-control     study. Setting: Dammam Medical Complex. Methods: thirty-four patients with chronic     non-specific neck pain. Participants will be allocated to one of two groups: experimental     group where treatment will involve conventional and manual interventions or the control group     where treatment will consist of the conventional approach only. The manual intervention will     consist of a sustained corrective scapular glide during neck movement in all directions.     Measurements will include: Visual Analog Scale, pressure pain threshold, neck range of     motion, scapular rotation measure and Neck Disability Index. Statistical analysis: all will     be done using SPSS version 22.0 for Mac. Means and standard deviations will be given as     descriptive statistics. Paired t-test will be used to study the effects of scapulothoracic     mobilization and exercises on neck range of motion and pain intensity. Independent t-test     will be used to compare the effects of the two interventions on pain intensity Key words:     Pressure pain threshold; Scapula; Intervention, Manual therapy, mobilization.   "
18289|NCT03046147|"     Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether     RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to     investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing     (forearm) regions before and after maximal weight loss at 1 year and after weight     stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be     studied at fasting and during oral glucose tolerance test.   "
18290|NCT03046134|"     Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and     mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death.     Community-acquired pneumonia (CAP) represents not only a frequent complication but also a     deadly cause in COPD patients. Inhaled corticosteroids, which are frequently used among COPD     patients increase the risk for pneumonia. The effect of pneumococcal conjugate vaccine 13     (PCV13) on the prevention of pneumococcal pneumonia among COPD patients in Korean population     has not been studied yet.      Several factors such as multi-lobar pneumonia, Pseudomonas aeruginosa pneumonia, and high     pneumonia severity are related to poor outcome of patients with COPD and pneumonia. Prior     pneumococcal vaccine has a beneficial effect on outcomes of pneumonia with COPD patients.     However, the effects of pneumococcal vaccine on the clinical outcome of COPD patients were     evaluated mainly on 23-valent pneumococcal polysaccharide vaccine (PPV23). The beneficial     effects of PPV23 rapidly fade out after inoculation, which is more prominent in old age     group. In this sense, PPV23 vaccine is not sufficient in preventing pneumococcal diseases in     COPD patients because COPD is the disease of old ages and mortality rate increases     exponentially with advancing age. Pneumococcal conjugate vaccine 13 (PCV13) can overcome the     waning phenomenon by the production of memory B cells. Although PCV13 is expected to be the     best option for the prevention of pneumococcal pneumonia in COPD patients, there are few     available studies supporting it.      In this study, we will conduct prospective, multi-center trial with the collaboration of     Korean pulmonologists in five university-affiliated hospitals. In this study, we will     evaluate influenza and pneumococcal vaccination status, the pathogen distribution, pneumonia     severity, and clinical outcomes of hospitalized pneumonia patients with COPD.      If successfully accomplished, this study will enhance the awareness of the preventive use of     PCV13 in COPD patients among Korean pulmonologists and, most importantly, it will lead to     protection of more COPD patients from pneumococcal pneumonia, one of the most frequent and     deadly complication.   "
18348|NCT03045380|"     The study was designed to investigate the effect of video games based physical activity     training on upper extremity functions, walking, balance and cognitive functions in persons     with multiple sclerosis (MS). For this aim, the participants with MS will be divided into     three groups: game based physical activity training, conventional rehabilitation, and no     intervention groups. The experimental groups will receive therapy sessions once a week for 8     weeks. The no intervention group will receive no intervention, they will be assessed at     baseline and after 8 weeks.   "
18291|NCT03046121|"     This study will address the effectiveness of Family-centered Function Focused Care (Fam-FFC).     Fam-FFC is a theoretically-based approach to care in which family caregivers partner with     nurses to prevent functional decline and other complications related to hospitalization in     older adults with Alzheimer's disease and related dementias. A systematic care pathway     promotes information-sharing and decision-making that promotes physical activity, function,     and cognitive stimulation during the hospitalization and immediate post-acute period. Our     goal in this work is to establish a practical and effective way to optimize function and     physical activity; decrease neuropsychiatric symptoms, delirium, and depression; prevent     avoidable post-acute care dependency; and prevent unnecessary rehospitalizations and     long-stay nursing home admissions, while mitigating family caregiver strain and burden.   "
18292|NCT03046108|"     The aim of this work trial is to compare the effectiveness of blind and ultrasound guided     injection for Morton neuroma in order to determine which is more appropriate as the initial     procedure in conservative treatment   "
18293|NCT03046095|"     It is well known that periods of weight training lead to increases in skeletal muscle size     and strength. In contrast, periods of inactivity such as bed rest or immobilization result in     losses of skeletal muscle size and strength. However, individuals experience variable     magnitudes of muscle size change in response to changes in mechanical tension, such that     certain individuals experience large changes in muscle mass whereas others do not. What is     not currently known, and will be the primary goal of the present investigation, is to     determine whether individuals who gain the most muscle mass with exercise training also lose     the most muscle when they are immobilized. The investigators hypothesize that individuals who     gain the most muscle with training will also lose the most with immobilization.   "
18294|NCT03046082|"     Observation of prescription usage of anaerobic antibiotics for patients admitted to the ICU     with pneumonia.   "
18295|NCT03046069|"     Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease     (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting),     long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled corticosteroids     (ICS). For subjects at higher risk of exacerbation, treatment with all these three classes of     medication is recommended. This study aims to explore the potential utility of a device     called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol     (FF/UMEC/VI) inhaler containing all three groups of compound. This is a mixed methods study     with a qualitative phase and a quantitative Discrete Choice Experiment (DCE) phase and will     be conducted in four stages: qualitative concept elicitation, DCE development, DCE piloting     and testing, and conduct of the DCE. The study will conducted in the United Kingdom (UK),     United States (US) and Germany and approximately 573 subjects with COPD will be included.   "
18299|NCT03046017|"     Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of     transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as     measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine     separate days not requiring an overnight stay in the hospital.   "
18300|NCT03046004|"     The aim of this study is to assess the effect of receiving information about the benefits and     harms of mammography screening on informed choice, decisional conflict, intention to     participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The     primary outcome is informed choice about breast screening (adequate knowledge, and     consistency between attitudes and intentions). The sample of participants is composed by 400     women from Catalonia and the Canary Islands (Spain) who will receive their first invitation     to participate in the EDBCP of the Public Health Service in a period of 2-4 months.   "
18301|NCT03045991|"     The purpose of this study is to determine the treatment effects of sequential combination of     aerobic exercise and cognitive training on cognitive function, physiological markers, daily     function, physical function, social participation and quality of life in stroke patients with     cognitive decline.   "
18302|NCT03045978|"     To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1,     IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in     children with feeding difficulty, and further to evaluate their regulation with feeding     difficulties (anorexia, picky eating behavior, feeding disorders with concurrent medical     conditions).   "
18303|NCT03045965|"     HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine     if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy     for a benign reason        -  has no increased risk of complications        -  has no negative side effects on ovarian function and subsequent cardiovascular disease          or incidence of fractures        -  implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be          conducted within national registers.   "
18304|NCT03045952|"     Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with     favorable long-term outcomes.Butthe results are mainly from single center reports.A larger     scale data need to be analyzed to evaluate the technique. This study is designed to     investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer     (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and     December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA     as a primary treatment will be enrolled from at least ten Chinese institutions with different     levels of MWA experience. All the patients will be closely followed up until June 2019.     Clinicopathologic data, recurrence and survival estimates, complications and     prognosis-relative factors will be measured.   "
18309|NCT03045887|"     This study is the first administration of GSK2292767 to humans. The study will evaluate the     safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat     inhaled doses of GSK2292767 in healthy smokers. This study is intended to provide sufficient     confidence in the safety of the molecule and preliminary information on target engagement to     allow progression to further repeat dose and proof of mechanism studies. This is a two part,     single site, randomized, double-blind (sponsor open), placebo controlled study. Part A will     consist of two 3-period interlocking cohorts to evaluate the safety, tolerability and     pharmacokinetics of ascending single doses of GSK2292767 administered as a dry powder     inhalation. Part B is planned to follow Part A and progression will be based on an acceptable     safety, tolerability and pharmacokinetic profiles. Subjects will receive repeat doses of     GSK2292767 once daily for 14 days during Part B.   "
18310|NCT03045874|"     The purpose of this study is to conduct community-engaged research (CEnR) with families and     pediatric providers caring for the children in those families to address the following     specific aims:        1. Examine parents' knowledge and perceptions about their 6-36 month old children's sleep          and objective characteristics of sleep, including (1a) self-reported and          actigraph-recorded characteristics of sleep, sleep habits, and difficulty; (1b) the          contributions of sleep habits and individual, family, community, cultural/social, and          health-related factors to sleep characteristics and sleep difficulty; (1c) consequences          of sleep difficulty; (1d) successful and unsuccessful strategies used to promote          children's sleep and sleep habits; (1e) preferences regarding sleep promotion          interventions for their children; and perceptions of the optimal timing to begin sleep          promotion intervention        2. Examine pediatric primary care providers' perceptions about (2a) the importance of sleep          and sleep habits for 6-36 month old children; (2b) factors that contribute to sleep          habits and sleep difficulty; (2c) successful and unsuccessful approaches to promote          healthy sleep habits, adequate duration and good quality sleep and assessment and          management of sleep difficulty in young children within the context of their families;          and (2c) barriers, facilitators, and preferences regarding sleep-promoting interventions          for families with young children;        3. Collaborate with families and providers to use the information obtained in Aims 1 and 2          to develop and refine a feasible, relevant, and acceptable sleep promotion program,          including procedures, protocols, patient materials, intervention fidelity plans, and          delivery methods.   "
18311|NCT03045861|"     GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the     treatment of HIV-1 infection in combination with other antiretroviral therapy (ART). This     study will be a 10-day monotherapy, open-label, adaptive, dose ranging, repeat-dose study.     This study will be conducted in two Parts (Part A and Part B) consisting single daily doses     of GSK2838232 and Cobicistat from Day 1 to Day 10. This proof of concept open-label study     will be aimed to characterize the acute antiviral activity, pharmacokinetics (PK), the     relationship between PK and antiviral activity, and safety of GSK2838232/cobi administered     across a range of doses over 10 days in HIV-1 infected patients. A cohort of 10 subjects will     be studied in Part I followed by interim (go/no-go) analysis of Part A data. On completion of     an interim analysis of part A data, further cohorts of 8 subjects will then be studied in     Part B in a parallel design in two or more cohorts (depending upon the data obtained in Part     A). Approximately 34 HIV-1 infected treatment-naive subjects will be enrolled during the     study. Subjects in both parts will have a screening visit within 30 days prior to first dose     and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation     will be approximately 6 Weeks.   "
18312|NCT03045848|"     LEADERS-FREE trial demonstrated the safety and efficacy of polymer-free drug-coated stent     (Biofreedom, Biosensors International Technologies, Singapore) in patients with high bleeding     risk. But, there are limited clinical evidences for extending these findings to generalized     patients who are eligible to PCI. Therefore, the purpose of this registry is to evaluate the     safety and efficacy of Biofreedom stent in patients with coronary artery disease.   "
18313|NCT03045835|"     Baska mask is a new novel supraglottic airway device with many salient features. The     investigators aim to determine the benefit of BASKA mask as an effective airway device for     laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to     smoothen the surgery and anaesthesia process in ambulatory care setting as well as reduce     perioperative complications.   "
18314|NCT03045822|"     There are an increase number of patients with cardiac implantable electronic devices (CIEDs)     such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The     current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this     group of patients to avoid any electromagnetic interference. These recommendations restrict     the use of BIA in many patients with heart failure in whom BIA might be of great interest in     detecting peripheral congestion and in guidance of treatment. However, it is not well known     whether BIA can affect the function of cardiac devices. Investigators aimed to test the     incidence of electromagnetic interference between BIA and CIEDs.   "
18315|NCT03045809|"     The current standard of care for urogenital infections in Rwanda is syndromic management.     Many urogenital infections are asymptomatic and therefore completely missed, and the     management of vaginal discharge syndrome is known to be suboptimal. The primary objective of     this study is to evaluate whether it is feasible to improve urogenital infection care in high     risk women in Kigali, Rwanda, using point of care (POC) diagnostic testing for HIV,     Trichomonas vaginalis (TV), and bacterial vaginosis (BV) in all women; POC testing for     Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and syphilis in pregnant women and     women assessed to be at high risk for these infections using a risk scoring questionnaire;     and management of vaginal candidiasis, urinary tract infection (UTI), genital ulcers/inguinal     bubos, and lower abdominal pain in women reporting relevant symptoms. The secondary     objectives of this study are 1) to evaluate the performance and 2) cost effectiveness of the     POC tests for CT/NG, TV and BV; and 3) to obtain the opinions of Rwandan stakeholders.   "
18352|NCT03045328|"     This phase I/II trial studies the side effects and best dose of venetoclax when given     together with ibrutinib and to see how well they work in treating patients with chronic     lymphocytic leukemia or small lymphocytic lymphoma that has come back or does not respond to     treatment. Venetoclax and ibrutinib may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.   "
18316|NCT03045796|"     Previous research has shown that many patients with kidney failure undergoing chronic     hemodialysis (HD) have a very low venous oxygen concentration, which may further decrease     during dialysis treatments. This may be due to a variety of factors including anemia,     compromised pulmonary function, and chronic fluid volume overload. Previous studies have     shown that low venous oxygen concentrations may increase the risk of cardiovascular events,     cognitive deficits, and mortality in HD patients.      The purpose of this study is to identify patients with hypoxemia during HD treatments and     characterize the extent of and implications of their hypoxemia. Specifically, the     investigators aim to examine the relationship between central venous oxygen concentration and     hemodynamic changes during dialysis treatment. The investigators will evaluate the     relationship between cardiac output as measured by the Task Force Monitor and central venous     oxygen saturation as measured by the Crit-Line Monitor and Wrist0x2 in HD patient. Data from     this study will provide insight into potential mechanisms responsible for side effects     associated with dialysis treatment, such as drops in blood pressure and cognitive     dysfunction.   "
18317|NCT03045783|"     The purpose of the study is to evaluate the efficacy and safety of prophylactic use of     antibiotics in endoscopic injection of tissue adhesive in gastric varices.   "
18318|NCT03045770|"     The aim of this study was to compare the efficacy and safety of mFOLFOX, mFOLFIRI and FOLFPTX     as first-line treatment in AGC or EGJA.   "
18319|NCT03045757|"     The overall goal of this study is to describe the oral motor skills of neonates born with     congenital heart defects, both before and after cardiac surgery, and to evaluate current     measures of feeding motor skills and feeding readiness in this population using the Neonatal     Oral Motor Assessment Scale (NOMAS) and the Infant Driven Feeding Scale.      The specific aims are to:        1. Describe the oral motor skills of infants with CHD before surgery as compared with          normal full-term newborn (>37 weeks) using the NOMAS        2. Describe the oral motor skills of infants with CHD after surgery as compared with those          same infants before surgery using the NOMAS.        3. Determine if the current Infant Driven Feeding Readiness Scale appropriately identifies          which children with CHD are ready for oral feeding. (A. Feeding Readiness Scale, B.          Quality of Nippling Scale at the 1st post- operative feeding evaluation)        4. Describe the unique characteristics of oral motor skills in infants with CHD (ie. Wide          jaw excursions, poor latch, etc.) Our hypothesis is that infants with CHD will have          dysfunctional sucking patterns before surgical repair as compared to normal newborns.          This dysfunctional sucking pattern in infants with CHD will have worsened post-surgery          as compared to pre-surgery. In addition, the Infant Driven Feeding Scale will be          utilized to predict that many infants with CHD will not be ready for oral feedings,          however most of those patients will go on to successfully take oral feedings.   "
18320|NCT03045744|"     The investigators have recently shown in two pilot incomplete SCI patients that long-term     paired associative stimulation is capable of restoring voluntary control over some paralyzed     muscles and enhancing motor output in the weak muscles (1). In this study, the investigators     will administer long-term paired associative stimulation to incomplete SCI patients in a     long-term manner, keeping each patient in the study for as long as continuous improvement is     observed.   "
18321|NCT03045731|"     The purpose of this study is to establish an ultrasound mathematical model using acoustic     radiation force impulse (ARFI) and contrast-enhanced ultrasonography (CEUS) for diagnosing     the status of renal allografts.   "
19835|NCT03025932|"     Patients who underwent laparoscopic repair of large hiatal hernias and anterior     fundoplication with mesh are examined for their recurrence rate one year after surgery.   "
18322|NCT03045718|"     The objective of this study is to determine whether horticultural therapy would improve the     psychological well-being older adults who are at risk of memory (cognitive) decline. 100     elderly subjects who are at risk of cognitive decline will be randomized into the active     horticultural therapy or to the waitlist control group. Sessions will be conducted weekly for     9 months, and participants will be assessed at 3 time-points: at the start of the study, at 3     months and at 9 months.      It is hypothesized that participants who undergo horticultural therapy will perform better on     neuropsychological tests when compared to control, and that they will have improved     psychological well-being and functional outcomes.   "
18323|NCT03045705|"     In the current study the investigators wish to evaluate the effect the doctors and midwives     in the delivery room have on the timing and modality of analgesia chosen by the participants.     The participants will be randomly divided into 2 groups. Both groups will be advised of the     different modalities of analgesia available during labor. One group will be managed in the     delivery room the same as if not part of the study, meaning the doctors and midwives will     treat the participants the way they usually do regarding analgesia. The second group of     participants will not be asked by the doctors and midwives about analgesia at all but will be     able to receive analgesia by a modality of choice at the timing of choice.   "
18324|NCT03045692|"     The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute     to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill     patients. In control group, colistin maintenance dosage will be decided using serum     creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be     decided using 4hr CrCl.   "
18325|NCT03045679|"     The aim of this prospective randomized controlled trial is to compare the two procedures     One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass     (RYGB) in relation to intraoperative and postoperative complications (classification of     Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus,     hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life,     operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.   "
18326|NCT03045666|"     48 patients, over the age of 18, with pulmonary arterial hypertension (PAH) classified as WHO     III-IV, that are all stable under Macitentan therapy ( medication for treating PAH patients),     will be recruited to the study through the pulmonary hypertension (PH) clinic at Soroka     Medical Center. The patients will be randomly divided into an intervention group, which will     exercise twice a week for 12 weeks, supervised by physiotherapists, and a control group,     which will only receive the medication. Tests will be performed before the beginning of the     intervention program, 6 weeks after it has begun, at the end of the 12 week program, and 3     months after finishing the program.   "
18353|NCT03045315|"     Previous studies in animal model showed clearly that lipid homeostasis influence oocyte     meiosis resumption. However Liver X Receptors pathway has never been investigated in human     ovocyte   "
18327|NCT03045653|"     Background: Endocrine therapy is an effective and safe treatment for hormone receptor     positive breast cancer. Unfortunately , endocrine treatment resistance occurs and there is an     urgent need for treatment alternative. Laboratory researches and clinical case reports     indicate that hormone receptor-high expressed breast cancer patients may potentially benefit     from high-dose Tamoxifen therapy, providing a new option for treatment strategy.      Aim: To explore the efficacy and safety of high-dose Tamoxifen to advanced hormone     receptor-high expressed endocrine therapy resisted breast cancer.      Methods: Eligible patients will be treated with tamoxifen 100 mg/d. Blood and tumor samples     will be obtained from the patients.      Primary endpoint: clinical benefit rate at 16 weeks(CBR)   "
18328|NCT03045640|"     Study activities were carried out to adapt and test a family-strengthening intervention to     improve child development outcomes among families facing adversity in Rwanda.   "
18329|NCT03045627|"     Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite     induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen )     has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies     to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of     standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is     efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires     daily administration because of its short half-life． Pegylated granulocyte colony-stimulating     factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project     is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in     China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and     aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C,     aclarubicin and G-CSF (CAG ).   "
18330|NCT03045614|"     Evaluation of the prevalence of kidney disease, hemodynamic predictors and long-term renal     outcome in patients with pulmonary hypertension.   "
18331|NCT03045601|"     Invasive coronary angiography is currently considered gold standard in the assessment of     coronary artery disease although the method has limitations. Most importantly invasive     angiography only depicts coronary anatomy without determining its physiological significance     i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional     flow reserve (FFR) is a catheterization technique for assessing the physiological     significance of a coronary artery lesion during invasive coronary angiography. Coronary     computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an     alternative route to diagnosis for patients with suspected coronary artery disease.     Computational fluid dynamics combined with anatomical models based on CCTA scans allows     determination of coronary flow and pressure, and has emerged as a promising diagnostic     modality called CT-FFR. In this Project New Mathematical algorithms are developed for     computation of CT-FFR. The main objective of this study is to determine the diagnostic     accuracy of CT-FFR values obtained by the new method compared with invasive coronary     angiography with fractional flow reserve and state-of-the-art dobutamin stress     echocardiography.   "
18332|NCT03045588|"     The investigators will examine the long-term effects of a combined training and diet     intervention that, acutely, increases fat oxidation during exercise. This is done with a 4     week intervention study with moderately trained cyclists. Performance is tested pre and post     intervention and muscle biopsies are obtained.   "
18333|NCT03045575|"     This is a prospective observational study designed to determine the feasibility and     acceptability of objectively measuring physical activity, sedentary time, and sleep using the     Fitbit Charge HR wristband. 50 patients who have been diagnosed with breast cancer and are     planning to initiate chemotherapy will be invited to participate in this study, and we will     measure general and breast-specific quality-of-life using PROMIS measures for 3-6 months     after completion of chemotherapy.   "
18334|NCT03045562|"     To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion     in subjects with STEMI who underwent primary PCI   "
18335|NCT03045549|"     The study was designed to evaluate the effectiveness of a novel kinematic biofeedback system     - SWORD Phoenix- in the rehabilitation after total hip replacement . SWORD Phoenix allows the     patients to perform independent rehabilitation sessions at home, under remote monitoring from     the clinical team. The investigators hypothesise that the clinical outcomes of a home-based     rehabilitation program will be at least similar to the outcomes of a traditional home-based     rehabilitation with face-to-face sessions. This is a randomised controlled trial with active     comparator. Patients will be enrolled and allocated pre-operatively into 2 groups:     intervention group and control group. Both groups will perform 8 weeks of rehabilitation     starting on day 7 after surgery. The intervention group will perform daily rehabilitation     sessions at home using SWORD Phoenix, under remote monitoring from a physical therapist. The     control group will perform 1h rehabilitation sessions 3 times a week, at home, given by a     physical therapist. Outcomes will be measured at weeks 4 and 8. The primary outcome is the     performance in the Timed-up-and-Go (TUG) test between in each patient in comparison with the     pre-operative score. Secondary outcomes will be measured in terms of: a) range of motion of     the hip joint (flexion/extension/abduction/adduction/internal and external rotation); b) Hip     Osteoarthritis Outcome Score; c) quality of life, as measured by the SF-36 scale.   "
18336|NCT03045536|"     Several surgical options for the reconstruction of massive bone defects have been described     and include biologic methods with autografts and allografts, and the use of tumor     endoprostheses (total femoral replacement, TFR). Several types of modular TFR are available,     but nevertheless unpredictable outcomes and high complication rates have been described from     most authors. The aim of the present study was to compare complication rates after TFR     performed with modular total femur prosthesis MML (Fa. ESKA/Orthodynamics) in patients with     and without malignant disease.   "
18349|NCT03045367|"     This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge     vitrectomy and phacoemulsification with intraocular lens implant in patients with     metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All     30 patients recruited underwent complete ocular examination, visual acuity measurement with     ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness     evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.   "
18337|NCT03045523|"     This clinical study is a phase IIa, multi-center, randomized, double-blind,     placebo-controlled, parallel group study to evaluate two doses of orally administered     GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR     mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.      Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must     be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days     at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active     doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days.     Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from     screening until the follow-up visit.   "
18338|NCT03045510|"     Myelodysplastic syndrome (MDS) is widely recognized as a clonal hematopoietic stem cell     disorder. Decitabine has been approved for the treatment of all subtypes of myelodysplastic     syndrome (MDS). However, the use of decitabine is often limited by its severe toxicity     represented by myelosuppression even at relatively low doses. In lower-risk patients     (including IPSS low and int-1 risk groups), treatment mainly aims at improving cytopenias,     especially anemia. However, although several drugs may improve anemia, sometimes durably,     most of lower risk MDS eventually require red blood cell (RBC) transfusions during their     disease course. Long term RBC transfusions lead to iron overload mainly due to an increase in     reticulo-endothelial iron recycling.Cardiac, liver and endocrine (diabetes mellitus)     dysfunction due to iron overload and often leading to fatal outcome has been reported in     heavily transfused lower risk MDS patients.      To date, the optimal regimen for decitabine treatment is not well established. In this study,     we perform a prospective analysis to explore the decitabine schedule for the treatment of     lower risk myelodysplastic syndrome patients with transfusion dependent.   "
18339|NCT03045497|"     This pilot clinical trial compares the use of contrast-enhanced ultrasound to     contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in     predicting treatment response in patients with liver cancer receiving transarterial     chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before     and after transarterial chemoembolization may help doctors predict a patient's response to     treatment and help plan the best treatment. It is not yet known if contrast-enhanced     ultrasound works better than contrast-enhanced MRI in predicting treatment response in     patients with liver cancer.   "
18360|NCT03045224|"     The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and     follow-up patients with peripheral arterial disease undergoing endovascular peripheral     intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and     radiologists contributed actively to this registry.   "
18361|NCT03045211|"     When postural imbalance and gait difficulties emerge in subjects with Parkinson disease,     patients are typically referred for a number of physical therapy sessions. However, there is     a critical gap in clinical practice on what to do once patients have completed their therapy     sessions. To fill this gap, the study team has developed a standing table with a tabletop     system that encourages weight shifting during upright standing (dynamic standing table),     and therefore may be a unique means to increase daily physical activity by integrating the     system with routine desktop activities of daily living. The purpose of this study is to     determine whether a post-physical therapy in-home physical activity program using the dynamic     standing table (as an adjunct to post-physical therapy standard of care—weekly physical     activity group sessions) is effective in sustaining the mobility benefits of physical therapy     in individuals with Parkinson disease.   "
18340|NCT03045484|"     Background:Although concurrent chemoradiotherapy is effective for improving disease-free     survival and overall survival in patients with locally advanced nasopharyngeal carcinoma.     However,the oral mucositis pain evoked by the chemoradiotherapy itself reduces food intake     and frequently halts the treatment. Thus, pain control is an important problem in     chemoradiotherapy for nasopharyngeal carcinoma.We performed to examine whether early     induction of low-dose, opioid from moderate pain reduced total dose of Oxycodone during     chemoradiotherapy, while improves the quality of life and reduce weight loss.      Objective:Present clinical trial to investigate the early introduction of opioids suppressed     the transient increase in the numeric rating scales(NRS) score for pain and compared with     conventional treatment.      Methodology:The subjects will recruit 130 patients who were hospitalized for nasopharyngeal     carcinoma. 130 patients were divided into two groups, depending on whether the pain was     moderate or severe when an opioid was introduced.Differences between groups were compared     using T test protected least significant difference for one-factor analysis of variance. All     statistical analyses were performed using SPSS(Statistic Package for Social Science)     software.P-values < 0.05 were considered statistically significant.   "
18341|NCT03045471|"     1. Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+     diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for patients     with AIDS associated CD20+ diffuse large B lymphoma.   "
18342|NCT03045458|"     The present study was compared the level of alveolar bone loss, clinical parameters and IL-1β     in PICF in one- or two-stage surgical procedures. Half of the patients were performed tissue     level implant while other half were performed bone level implant.   "
18343|NCT03045445|"     Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol     CT in patients at high-risk of HCC.      patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this     study and allocated to either standard protocol or double-low dose protocol using spectral CT     with low radiation dose and low dose of contrast media, within clinically accpetable range.   "
18344|NCT03045432|"     Several factors associated with the hemiplegic shoulder pain after stroke includes rotator     cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of     shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and     brachial/axillary neuropathy. In this study, the investigators aim to usie high frequency     ultrasound to evaluate the relationship between stroke patients with poor shoulder motor     function and shoulder tendon injury. Also, assumed that performing passive range of motion     and positioning training might prevent tendon injury of shoulder and hemiplegic shoulder pain     in either acute or chronic stage of stroke.   "
18345|NCT03045419|"     It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide     additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to     reduce the necessity of biopsy in patients with high risk of HCC.      Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced     MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.   "
18346|NCT03045406|"     Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective     randomized open blinded end-point (PROBE) study   "
18347|NCT03045393|"     The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects     the amount and activity of folate receptor alpha proteins in tumor cells of patients who have     completed standard neoadjuvant treatment and are scheduled to have their tumors surgically     removed.   "
18350|NCT03045354|"     The purpose of this study is to determine the effect of carbohydrates of familiar breakfast     meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and     overweight or obese (OW/OB) children.   "
18354|NCT03045302|"     The purpose of the protocol is evaluate the safety, the pharmacodynamics and the     pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.   "
18355|NCT03045289|"     This research will examine the feasibility of conducting a strict whole-food, plant-based     dietary intervention with intensive group education in women with stable metastatic breast     cancer currently undergoing conventional treatments. In addition, this research will provide     preliminary data on dietary intakes and the effect of plant-based nutrition on numerous     outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood     biomarkers linked to cancer progression, and numerous symptom questionnaires.   "
18356|NCT03045276|"     The purpose of this study is to determine the effectiveness of behavioral feedback plus     economic incentives to promote treatment adherence among a large diverse population of     adolescents and young adults (AYA) with kidney transplant (KT) or spina bifida (SB).   "
18357|NCT03045263|"     The purpose of this study is to evaluate the application of a modified version of PRT     designed specifically as a parent-training model via telemedicine, with the goal of     increasing access to empirically validated care. The project will feature an 18-week trial of     parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with     ASD. Intervention will focus on enhancing the following developmental skills: expressive and     receptive language, play, and social interaction. Outcome measures will address changes in     the aforementioned domains during structured observation and standardized assessment.   "
18358|NCT03045250|"     Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in     subjects with Type 1 Diabetes.   "
18359|NCT03045237|"     Healthy Bellies is an intervention program with pregnant women, based on the promotion of     healthy lifestyles. It aims to evaluate the impact of the program in the health of both     pregnant and newborn. This trial is being conducted with pregnant women, divided into control     and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 -     postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly     physical exercise classes and the control group has the basic information that is usually     provided by health professionals. With this program, it is expected to contribute with     evidence to the best practice in the field of interventions in pregnancy and improve health     outcomes of both pregnant and newborn.   "
18575|NCT03042429|"     Improvement of event free survival of high-risk neuroblastoma patients by introduction of two     additional topotecan containing chemotherapy cycles into the multimodal standard treatment     (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and     consolidation therapy).   "
18362|NCT03045198|"     In collaboration with Dr.Birgit Alteheld, Institute of Nutrional Sciences of the university     of Bonn, Germany the following effect is explored: Effect of a 4 week therapy with AZT on     synthesis of lipoproteins as well as Docosahexaen and other fatty acids in patients with     Cystic Fibrosis (CF). Moreover proinflammatory cytokines in blood and sputum are of interest.   "
18363|NCT03045185|"     Aim: The aim of this prospective study was to evaluate the treatment outcomes of regenerative     endodontic technique (RET) for the management of traumatised non-vital immature teeth in     children. Methodology: This study aims to recruit 25-30 healthy children with traumatised     non-vital immature upper incisors to be treated with bi-antibiotic regenerative endodontic     technique. Patients will be reviewed clinically at 3m,6m,9m,12m,2y,and 3 years and     radiographically at 3m,9m, 2y,and 3 years. One operator will undertake all treatments,     clinical reviews and standardised radiographic exposures. Radiographic analysis will be     carried out by two calibrated experienced clinicians. Standardised photographs will be taken     at 3m,12m,2y,and 3 years and crown colour changes will be assessed using a standardised     validated methodology.   "
18364|NCT03045172|"     Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS     causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which     may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop     vulvar cancer.      The current gold standard treatment for lichen sclerosus is potent steroids creams. When     used correctly, steroid creams help to decrease the symptoms of itching and burning and can     prevent further vulvar scarring. In addition, proper treatment reverses the underlying     inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams     may have serious side effects that include thinning of the skin, fungal infections, and     lowering the immune system.      Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing,     without serious side effects, in a very wide range of medical conditions such as diabetic     foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP     works because of its high level of proteins that help with wound healing. It is also apparent     from the majority of published studies that PRP therapy has minimal risk of scar tissue     formation or significant bad side effects.      Recently, there was an exploratory study of twelve subjects that used PRP for the study     treatment of lichen sclerosus. While this study showed good success, the study was limited     because of its small size and lack of placebo (a drug or study treatment that contains no     active ingredient) control.   "
18365|NCT03045159|"     The purpose of this research is to evaluate the efficacy of the Strong Families Strong Forces     Parenting Program compared to a parental self-care (Strong Parents) condition in a sample of     150 Active Duty Families with children ages birth to 5 years.   "
18366|NCT03045146|"     FRench Acute cerebral multimodal imaging to select patient for MEchanical thrombectomy is a     prospective multi-center study to determine if multimodal imaging could identify patients who     may and those who may not benefit from an endovascular clot removal procedure within 6 hours     after stroke onset.   "
18367|NCT03045133|"     Introduction. Despite the advantages associated with the use of remifentanil during total     intravenous anesthesia (TIVA), it has been observed a frequent difficulty in the control of     postoperative pain due to the risk of developing hyperalgesia and acute tolerance associated     with the administration of this opioid. There is evidence that NMDA receptors are involved in     the development of these changes. Methadone is an opioid that exhibits analgesic potency     similar to that of morphine but has NMDA antagonist activity and longer duration of action as     additional features. The objective of the study was to evaluate the quality of recovery     (QoR40) of patients undergoing TIVA for laparoscopic cholecystectomy and who received     morphine or methadone to control postoperative pain. Methods. Patients aged 18 to 65 years,     physical status ASA I and II, submitted to total venous anesthesia (propofol and     remifentanil) for laparoscopic cholecystectomy and eligible to participate in this     prospective and randomized clinical study will be evaluated. After induction of anesthesia,     patients will receive a solution containing 0.1 mg.kg-1 morphine (MF group) or 0.1 mg.kg-1     methadone (MT group). Data on the presence of pain, nausea, vomiting, tremor, drowsiness,     presence of SpO2 <92%, even with O2 face mask (5 L.min-1) and length of stay will be recorded     at PACU. The pain will be evaluated every 15 minutes on a verbal numerical scale (ENV) from 0     to 10. E.v. morphine 0.1 mg.kg-1 (MF group) or methadone 0.1 mg.kg-1 (MT group) will be     administered every 15 minutes to obtain the score below 3. After discharge from the PACU, all     patients will receive intravenous ketoprofen every 12 hours and dipyrone every 6 hours. For     cases where the patient considers the analgesic regimen insufficient, tramadol (100 mg) will     be administered intravenously at 8-hour intervals. The consumption of analgesics, the     intensity of pain, the occurrence of nausea, vomiting and other complications in the ward     will be recorded. The application of the questionnaire (QoR40) will be performed in the ward     the morning after the surgery by a medical student.   "
18368|NCT03045120|"     This non-interventional, prospective study will characterize the impact of three approved     first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and     metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and     initiating first-line TKIs in routine clinical practice in the US. All treatment decisions     will be determined at the discretion of the treating physician(s) and data identifying the     cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples     (collected following 8 hours of fasting) will be collected during standard of care     (SOC)/routine office visits. Additional research imaging will be performed and will be     reviewed by core imaging laboratory. As the study is collecting data on management of CML,     this study will not influence the prescribing or management practices at participating sites.   "
18369|NCT03045107|"     During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic     anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with     extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However,     the level of evidence coming from the currently available literature is low, based on the     results of a few small and heterogeneous retrospective non-randomized studies. A randomised     controlled trial is warranted to challenge these two procedures. The aim of this randomized     controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right     colectomy for right colon tumors.   "
18370|NCT03045094|"     This study evaluates the effect of head and neck movement in children on endotracheal tube     (ETT) tip displacement undergoing head-and-neck surgeries. The tube-tip displacement will be     measured using flexible fiberoptic bronchoscope.   "
18486|NCT03043586|"     This is a human, prospective and retrospective, single-center study of patients who have     undergone treatment for acromegaly in New York City since 1981. The project will     characterize, among other factors, the treatment methods received by patients, who     administered the treatments and the success of this therapy in terms of biochemical control.   "
19836|NCT03025919|"     Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in     diabetes screening in Chinese natural population   "
18371|NCT03045081|"     To develop and test a web-based patient empowerment platform, PainTracker Self-Manager     (PTSM), that can support integrated multimodal care in a variety of specialty and primary     care settings. The investigators will adapt PainTracker, a web-based outcome and treatment     tracking tool already deployed in multiple University of Washington clinics to create the     PTSM self-management tool that helps assess, engage, activate, and support patients' efforts     to self-manage their chronic pain in collaboration with their clinicians. PTSM design will be     based on 4-phase patient engagement strategy derived from Acceptance and Commitment Therapy.     Phase 1 focuses on achieving consensus on the clinical problem definition, treatment goals     and timeline. Phase 2 focuses on promoting values-based action and acceptance of pain. Phase     3 focuses on providing skills in chronic pain self-management with close monitoring of     patient reported outcomes and actigraphy. Phase 4 focuses on providing autonomy support to     promote maintenance of self-management behaviors. Phase 5 involves generating a patient     registry with the above data for use in quality improvement research. The investigators will     engage patients, providers and investigators in designing PTSM, reviewing prototypes, and     conducting usability testing. In a 6-month clinical trial, the investigators will compare 50     intervention patients from the UW Center for Pain Relief who receive PTSM to 50 historical     control patients who have received the basic PainTracker. The primary outcome will be chronic     pain self-efficacy, with secondary outcomes of: chronic pain acceptance, perceived efficacy     in physician-patient interactions, and patient and provider satisfaction. Development of the     PTSM platform will support the dissemination of the multimodal interdisciplinary care for     chronic pain that is recommended in the National Pain Strategy, and may help chronic pain     care meet the goals of the Triple Aim: better patient experience, better patient outcomes,     with lower costs.   "
18372|NCT03045068|"     Hypothesis:      Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and     administration of donor apheresis platelets just prior to termination of bypass will assist     in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood     products after cardiac surgery.      Background:      What is the Problem? - Bleeding, Transfusion and Outcomes        1. Excessive bleeding after neonatal cardiac surgery has been independently associated with          increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart          surgery has multiple etiologies such as immaturity of the building blocks of          coagulation, effects of deep hypothermia, longer CPB times, altered flow states and          dilutional state induced by being on CPB leading to low platelet count, low platelet          function, low fibrinogen levels, altered fibrinogen polymerization, complement          activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass          in children was deemed to be the CPB circuit volume and the effect of hemodilution.4        2. The dilutional coagulopathy after neonatal CPB requires intense damage control          resuscitation with massive transfusion of platelets, packed red blood cells (PRBC),          cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a          previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates          undergoing open-heart surgery there was a significant drop in platelet counts after          bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this          drop , the average intraoperative transfusion load in neonates undergoing cardiac          surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg,          cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In          addition 72% of these patients were exposed to a 3-factor prothrombin complex          concentrate (Bebulin®). Although this throw the kitchen sink approach is effective in          achieving hemostasis, it comes with significant effects on post CPB hemodynamics,          constantly changing hematocrit, variable blood volume with inability to achieve steady          state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary          hypertension.      Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has     distinct advantages of reducing transfusions and improving outcomes.   "
18385|NCT03044899|"     STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult     surgical patients in Africa.      STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study     of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum     of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study     design.      The primary outcome is in-hospital postoperative complications in adult surgical patients in     Africa. Secondary outcomes include in-hospital mortality and the relationship between     postoperative complications and postoperative mortality.      The intention is to present a representative sample of surgical outcomes across all African     countries. This study will run between February and March 2016.   "
18386|NCT03044886|"     The object of the study was to evaluate the direct effect of high dose vitamin D     supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.   "
18373|NCT03045055|"     Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly     90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or     endovascular treatment is the most effective strategy to reduce brain damage. However, after     recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may not     only weaken the therapeutic effects of timely reperfusion but also impede patients' recovery.     Moreover, thousands of neuroprotective drugs effective in experimental models have been     proved to be unsuccessful in clinical trials. Therefore, effective strategies are urgently     needed to prevent and treat cerebral reperfusion injury and further improve the prognosis of     acute ischemic stroke.      Researchers applied remote ischemic conditioning to mouse model of focal cerebral reperfusion     injury and found that it could reduce cerebral infarct size. And clinical researches     demonstrated that remote ischemic conditioning was an effective strategy to improve cerebral     perfusion and prevent recurrent stroke in patients with ischemic stroke. However, whether     remote ischemic conditioning is safe and effective in protecting patients with large-vessel     ischemic stroke and undergoing endovascular treatment is still unknown. The investigators'     hypothesis is that RIC is a safe, feasible and effective strategy to reduce cerebral     reperfusion injury after endovascular treatment.   "
18374|NCT03045042|"     This study aims to analyze serum and plasma samples from patients with late onset Pompe     disease treated and not treated with enzyme replacement therapy (ERT) to identify microRNA     that could be specific of the disease. The investigators will correlate the concentration of     these microRNA with several muscle function tests and quantitative muscle MRI to know whether     they are good biomarkers of progression.   "
18376|NCT03045016|"     After a traumatic event such as an accident or an assault, victims may experience intense     stress symptoms that may evolve into post-traumatic stress disorder (PTSD). It is a     frequent and serious pathology, which can be complicated by depression, addiction or suicide.     Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is     an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the     vicious circle of stress and prevent the development of the disease. The objective of this     study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an     emergency department after trauma.   "
18377|NCT03045003|"     The aim of this phase II study is to test by feasibility and efficacy of two     interprofessional supportive care interventions with different intensities to facilitate     resilience in patients and thereby to reduce their unmet supportive care needs.   "
18487|NCT03043573|"     The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare     Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs.     Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive,     affective, and functioning outcomes.   "
18378|NCT03044990|"     Several epidemiologic studies reported that patients with renal insufficiency might have     increased cardiovascular disease-related mortality rates after Percutaneous coronary     intervention (PCI) . The increased risk in this population may be related to the less use of     standard guideline-based treatment and the resulting inability to perform PCI effectively.     Recently, with the technology improvement and the progress in clinical trials, Chinese     guidelines have made new recommendations about the patients with acute coronary syndrome(ACS)     in different states of renal function. However, scant epidemiologic information exists on the     prognosis of those patients, especially in Henan. And there is still some uncertainty whether     those patients are using the latest guideline recommended treatment.      This multicenter, prospective, observational study is aimed to evaluate the long prognosis in     patients with acute coronary syndrome complicated with renal insufficiency, and to analysis     its related factors that influence the outcomes.   "
18379|NCT03044977|"     This study is designed to identify the best tolerated doses of [131]Iodine-MIBG and     [90]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs     (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the     safest and best tolerated doses of these drugs (when combined together) is unknown.   "
18380|NCT03044964|"     The post-marketing study is designed to evaluate the activity level and exercise tolerance of     patients with deferred percutaneous intervention due to FFR (fractional flow reserve) greater     or equal to 0.81 and treatment with Ranolazine versus placebo.   "
18381|NCT03044951|"     It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus     radiofrequency ablation for paroxysmal atrial fibrillation.   "
18382|NCT03044938|"     Contextualization: Exercise is a common triggers of bronchospasm in patients with asthma and     healthy subjects. To prevent these symptoms frequently they have to use Short-Acting     Beta2-Agonists. However, the cardiovascular effects of salbutamol during and after exercise     remain poorly known.      Objective: To evaluate the effect of salbutamol on heart rate and blood pressure during     exercise in patients with moderate or severe asthma and healthy individuals.      Methods: A randomized, double-blind, crossover study will be conducted which 13 individuals     with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59     years.      Patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg     Salbutamol or 4 placebo puffs. The order of use of placebo or salbutamol will be drawn.     During the protocol, heart rate, blood pressure, perception of exertion and peak expiratory     flow will be monitored.   "
18383|NCT03044925|"     Compare the safety and efficacy of remote magnetic navigation-guided ablation and     cryoablation for patients with persistent atrial fibrillation.   "
18384|NCT03044912|"     Recent phase III trials have confirmed the efficacy and safety of mirabegron in the treatment     of overactive bladder (OAB) in Europeans, Australians, North Americans, Japanese and Asians.     Whether mirabegron 25mg or 50mg should be used as the first line treatment for OAB has not     been determined yet. The dose effectiveness relationship between 25mg and 50mg mirabegron has     also not been investigated yet. Hence, investigators have conducted this post marketing study     in order to evaluate the efficacy and safety between mirabegron 25mg and 50mg in Taiwanese     people with symptoms of OAB.   "
18387|NCT03044873|"     The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the     systemic exposure of rosuvastatin in healthy participants.   "
18390|NCT03044834|"     Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent     malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma     Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were     identified in 2009.      Three histologies are described: type 1 purely cystic, type 2 combined and type 3 solid.     Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is     possible from type 1 to type 2 or 3 in 10% of the cases.      Since 2009, DICER 1 mutations research is proposed systematically to all families.      PPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows     bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can     be difficult because of the proximity with congenital cystic adenomatoid malformation.      The French society of paediatric oncology recommends surgery at first instance. PPB type 1     remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy     depends on the PPB type and the quality of the resection. There is a real interest to analyse     the French series.      The prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1     survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48% in     type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary     invasion and quality of surgery.      Early local relapses are possible and late ones concern more often type 2 and 3 with more     cerebral metastasis.      In 2009, the french cases were collected, but no update has been performed since. The aim of     this retrospective review of the cases since 2000, is to audit the care of PPB patients in     France and update the French rare tumour database.      Evoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no     radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion     and PPB type 1. Radiological presentation is however overlapping. Another aim of this study     will be to look for a predictive sign of type 1 PPB.   "
18391|NCT03044821|"     Spina bifida is a neurological abnormality characterized by an opening in the skin and     exposure of the spinal cord on the back of the baby at the time of birth. The complete     closure and separation of the spinal cord from the skin occurs in the first month of     pregnancy.      This form of spina bifida is associated with leg weakness, sensation loss, and bowel and     bladder incontinence. The majority of patients (>80%) also develop increased fluid in the     brain, called hydrocephalus, and require additional surgery to treat this problem. Standard     treatment of myelomeningocele (MMC) involves closing the opening in the back within the first     3 days of life. The surgery releases the spinal cord from the skin and brings the skin edges     together to prevent infection and injury to the exposed nerves. Of note, this type of surgery     does not improve function.      The investigators want to study the open in-utero fetal surgery technique in patients who are     candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of     35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the     United States.   "
18392|NCT03044808|"     Single center double blind randomised controlled trial. 60 subjects. Giving lidocaine IV or     saline to patients due to robot assisted colorectal surgery. Primary outcome is cumulative     morphine consumption at 24 hours.   "
18488|NCT03043560|"     This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a     novel treatment target for mood disorders through the administration of the KCNQ-selective     channel opener ezogabine (Potiga, GlaxoSmithKline; FDA-approved for the treatment of seizure     disorders).   "
18489|NCT03043547|"     is an open label, randomized, multicenter phase II trial   "
18393|NCT03044795|"     In tumors with a defect in the homologous recombination (HR) pathway, double-strand break     repair is partly impaired. Patients with HR deficient tumors benefit from therapies that     induce DNA lesions requiring HR for repair. These therapies include platinum compounds and     inhibitors of the enzyme PARP-1. At this moment, selection for PARP inhibitor treatment     relies on detection of germ-line or somatic mutations in the HR pathway genes BRCA1 or BRCA2.     However, not all HR deficient tumors have a BRCA gene mutation, the BRCA genes can also be     silenced by promoter methylation. Moreover, the HR pathway can be defective due to mutations     in other HR genes. In addition, the presence of a BRCA gene mutation does not guarantee     defective HR since mutations in other genes (e.g. TP53BP1) can restore HR despite the     presence of a BRCA1 mutation. Since all patients with tumors that are HR deficient may     benefit from PARP inhibition, better tools are required to identify these patients. Recently,     a functional ex vivo test for HR deficiency (the RAD51 assay) became available for clinical     use. The RAD51 assay can identify patients with functional defects in HR-repair and may     predict which cancer patients are likely to benefit from PARP inhibition. The purpose of this     study is to investigate whether the RAD51 assay can select patients who will benefit from     treatment with the PARP-inhibitor veliparib.   "
18394|NCT03044782|"     The purpose of the current project is twofold; first to determine what personal, historical,     logistical, and environmental factors preclude women from obtaining medical care for CCCA     hair loss. Because damage from CCCA is irreversible, early identification and treatment is     paramount to limiting the negative ramifications of the disease. Second, to investigate how     CCCA hair loss, a common occurrence in the Black population, can be a significant     psychological impediment to lives of affected Black women. Based on previous research on the     psychosocial impact of generalized hair loss in Black women, it is fair to consider that CCCA     hair loss also leads to problems with self-esteem and participation in daily life activities.     This research, the first of its kind, will add to existing knowledge of CCCA by investigating     the quality of life and barriers to care of patients with this condition. The goal of this     study is to illuminate what stands in the way of secondary and tertiary prevention of CCCA     patients and tailor treatment strategies to address their needs. The results of this study     will be instrumental in modifying dermatology resident training, adding to existing     dermatology management guidelines, and even developing public health advocacy programming.   "
18395|NCT03044769|"     Congenital lung anomalies include different pathologies such as congenital cystic adenomatoid     malformation, pulmonary sequestration, bronchial atresia, emphysema, bronchogenic cyst. They     concern less than 1/10000 births and their physiopathological origin is still poorly     understood. The main goal of this project is to pool the cases from different swiss centers     on a prospective cohort study, first to increase knowledge of clinical and radiological     evolution and their correlation with histological data, and second to analyse the     pathological embryological mechanism underlying these malformations.   "
18396|NCT03044756|"     Omitting the GnRH antagonist on the day of the trigger can be cost effective and more     convenient to the women. We will study the impact of omitting the antagonist dose in a     prospective randomized trial   "
18397|NCT03044743|"     This study will evaluate the safety of PD-1 knockout EBV-CTL cells in treating EBV     (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be     collected for research purposes.   "
18413|NCT03044535|"     The purpose of this study is to develop a measurement system to assess adjustment to     mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD])     and health-related quality of life (HRQOL) in patients with advanced heart failure who     receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory     Support: Adjustment and Quality of Life (MCS A-QOL).   "
18398|NCT03044730|"     The purpose of this study is to see whether a combination of two different drugs -     pembrolizumab and capecitabine - is safe, and if it might be effective in treating triple     negative and hormone-refractory breast cancer. Pembrolizumab is a type of drug that contains     an antibody. Antibodies are the part of your immune system that finds things that don't     belong in your body, such as bacteria or viruses. The antibody in pembrolizumab finds and     blocks a protein, which allows your immune system to target and destroy cancer cells.     Pembrolizumab is Food and Drug Administration (FDA) approved for other types of cancer. It is     not approved for breast cancer, meaning that it is an experimental or investigational     treatment. Capecitabine is a type of chemotherapy pill that is a standard treatment and     FDA-approved for breast cancer. It stops the cancer cells from being able to multiply.   "
18399|NCT03044717|"     The purpose of this research study is to assess comfort of cardiology fellows and faculty     with nutrition and its role in cardiovascular disease and to determine if increasing     education in this arena will change clinical practice.   "
18400|NCT03044704|"     The study is a prospective-observational, explorative single-centre cohort study aimed to     examine the influence of hemodynamic and geometric parameters on the progression of     atherosclerotic alterations in peripheral vessels (carotids, femoral artery). Atherosclerotic     alterations (IMT, plaque volume) will be measured with a ultrasound (IMT measurements and 3D     quantitative plaque volumetry) and magnetic resonance imaging (MRI). Geometric parameters     (e.g. carotid/femoral bifurcation angle, carotid/femoral bifurcation area) are assessed with     magnetic resonance imaging (MRI) and also 3D ultrasonography.      A total of 100 patients with an asymmetrical plaque distribution in carotid and femoral     arteries will be tested. Only patients who are already enrolled in the Correlation of     Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin     (NCT01895725) and who are tested prior for an asymmetrical plaque distribution will be     included in this study. MRI will be performed once whereas ultrasound imaging will be be     repeated once per year (up to five times) to assess changes in these parameters over time.     Also plasma samples will be collected once yearly and tested for traditional and novel     cardiovascular risk factors.      The primary endpoint of the planned study will be the correlation between geometrical and     hemodynamic parameters as stated above and the progression of atherosclerosis as measured by     plaque volume and IMT in the carotid and femoral arteries, respectively.      Secondary endpoints will include the correlation of geometrical and hemodynamic parameters     with established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors     (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion     molecule-1 (ICAM-1), CETP TaqIb polymorphism), with cardiovascular event rate, plaque     localization, plaque morphology and the additional predictive value of geometrical parameters     compared to an established risk score (SCORE card).   "
18490|NCT03043534|"     This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with     symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be     divided into two groups: the Control group of 20 subjects and the Experimental group of 20     Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.      All subjects will use their normal razors and shave products during the six week study. The     Experimental group of subjects will also be given the study product Pre-Shave Gel and     Cleansing Brush.   "
18401|NCT03044691|"     The primary purpose of our study is to conduct a pilot, practice-based intervention focused     on increasing adherence to the 6As for youth ages 11 through 17 years. The 6As are: (1)     Anticipate (future use), (2) Ask (about tobacco use), (3) Advise (advise the patient to     quit using tobacco), (4) Assess (the patient's readiness to quit using tobacco), (5)     Assist (by setting a quit date, providing materials on quitting tobacco, providing tobacco     cessation medications, and referring the patient for additional services and/or counseling) ,     and (6) Arrange (by re-contacting the patient after their quit date and arranging a     follow-up visit).   "
18402|NCT03044678|"     This study was designed to conceptualize a school-based prevention program or childhood     anxiety.   "
18403|NCT03044665|"     The clinical efficacy of LDL-lowering therapy have been proven with strong evidences and more     emphasized. However, there are also growing concerns that high-intensity statin would be     related to increased risk of adverse effects. In addition, there was an inconsistency of     efficacy of statin according to ethnic population. Asian population showed more profound LDL     reduction not only from high potent statin but from moderate to low potent statin.     Conventional strategies for lowering LDL-cholesterol was focused on statins, therefore     doubling of previously described dose of statin would be common way in patients with     inadequate lowering LDL-cholesterol level. Additive ezetimibe will also an alternative     strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of     high-intensity statin to fulfill sufficient LDL-cholesterol lowering effect. We will evaluate     whether additive ezetimibe with rosuvastatin will have comparable clinical efficacy in terms     of clinical outcomes and goal attainment of LDL-C compared to rosuvastatin monotherapy.   "
18404|NCT03044652|"     The aim of the study is to gain further experience with regard to the performance of the     medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol.   "
18405|NCT03044639|"     The randomized, double-blind, multi-centric study performed in four parallel groups to     compare all lipid emulsions, which can be used as a part of PN. Patients with home parenteral     nutrition due to stable intestinal failure, were randomly assigned to receive parenteral     nutrition with one the following lipid emulsions:        -  Long-chained triglycerides (LCT group)        -  Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))        -  Olive oil/ LCT (80:20, OO group))        -  SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)   "
18406|NCT03044626|"     AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic     non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in     2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous     NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study Group     B.   "
18407|NCT03044613|"     Anti-PD-1 (nivolumab) or Anti-PD-1/CTLA-4 (ipilimumab) administration in the pre-operative     setting and nivolumab combined with chemoradiation will be safe and feasible in patients with     resectable distal esophageal/gastroesophageal junction cancer and will change cellular and     molecular characteristics of the tumor microenvironment that will improve survival.   "
18408|NCT03044600|"     Objectives:        1. To better define the differences in molecular genetics of parathyroid tumors in patients          with MEN1, single gland parathyroid disease in patients less than 50 years old and          single gland disease in patients greater than 50 years old.        2. To better define the incidence of HRPT2 mutation in young patients with primary          hyperparathyroidism and determine whether routine testing in these patients is          indicated.   "
18409|NCT03044587|"     AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II     trial   "
18410|NCT03044574|"     The aim of the study is to evaluate efficacy and safety of VTE prophylaxis by the combination     of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins     (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at     high and extremely high risk for venous thromboembolism.   "
18411|NCT03044561|"     The aim of this study is to evaluate the effect of sildenafil citrate on endometrial     development in women with history of recurrent implantation failure after IVF   "
18416|NCT03044496|"     Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes     causing increased arterial blood flow and venodilatation .      Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing     oxygen saturation by detecting the absorption and reflection of near-infrared light .      The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula     revision has not yet been examined. We postulate an increase in tissue oxygenation by     sympathicolysis caused by peripheral regional anesthesia that might be the reason for     beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular     plexus block in this group of patients.   "
18417|NCT03044483|"     When infection strikes, the body's immune system reacts by producing chemicals in the     bloodstream and changes in white blood cells to attack the infecting organism (bacteria,     viruses or other organisms) and prevent it spreading. This is termed the 'inflammatory     response'. Though beneficial in fighting infection, this response can sometimes be excessive,     causing harmful effects on body organs. This is termed the 'systemic inflammatory response     syndrome' and when linked to infection is termed 'sepsis'.      Previous research has shown that in patients who have sepsis, the small blood vessels     supplying oxygen and nutrients to muscles and other organs (the microcirculation) become     abnormal and do not function as they would in health. However, it is difficult to assess the     function of microcirculation in clinical practice, and we want to find new, easier ways of     doing so.      The aim of this study is to test a new method for assessing the function of these small blood     vessels, by directly visualising them using a highly sensitive microscope, the size of a pen,     placed under the tongue. By understanding the flow of blood in these vessels in healthy     individuals, we will gain a better understanding of how these vessels are affected in     illness.   "
18491|NCT03043521|"     The purpose of this study is to compare and evaluate impact on pharmacodynamic     characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male     volunteers   "
18671|NCT03041168|"     The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed     by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will     compare a new application of a technology, the CSS device, to reference standards for     assessment of carotid disease.   "
18418|NCT03044470|"     AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain     following root canal therapy.      METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth     were included. The patients were assigned randomly into two groups of 20 patients each. The     teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2     (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft     Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at     12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used     for statistical analysis.   "
18419|NCT03044457|"     A new operation technique was established (reversed gap technique for implantation of total     knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome     shall be evaluated using the conventional gap technique as control in a RCT study.   "
18420|NCT03044444|"     In this study, the effect of citrus extract on exercise performance will be investigated. The     study consists of three groups: one group will receive a high dose citrus extract, one group     will receive a low dose citrus extract and the last group will receive a placebo. After four     and eight weeks the effects on performance are measured through a Triple Wingate cycling     test, handgrip strength, vertical jump and 1600m run trial. It is expected that exercise     performance will increase in the citrus extract groups, compared to the placebo group.   "
18421|NCT03044431|"     The purpose of the Lung Institute is to collect and isolate a patient's own cells and     platelet rich plasma (PRP) and deliver the product back to the patient the same day. Lung     Institute's treatment is limited to self-funded patients with chronic lung disease- chronic     obstructive pulmonary disease (COPD) and restrictive lung diseases such as pulmonary fibrosis     (PF) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are     harvested through venous or bone marrow collection techniques.      The hypothesized outcomes of therapy are safety and minimization of adverse events, a     perceived improvement in the patient's lung condition (to be determined by their perceived     quality of life), an improvement in the FEV1 among COPD patients, the ability to reduce     supplemental oxygen use, the ability to function well without the use of rescue inhalers,     reduction of secondary pulmonary infections, reduction in emergency room visits and     exacerbations related to their disease.   "
18422|NCT03044418|"     The study examines the special endotracheal laser tube during anesthesia of endolaryngeal     laser surgery.   "
18423|NCT03044405|"     The aims of the study are:        1. To evaluate the feasibility of echocardiography monitoring in postoperative unit;        2. To assess diagnostic value of different focussed echocardiography parameters to define          fluid responsiveness for non-cardiac hypotensive spontaneously breathing patients after          major abdominal surgery.   "
18424|NCT03044392|"     The current standard of practice for the maintenance of epidural analgesia is through use of     a continuous infusion pump. Enhanced technology now supports the use of programmed     intermittent bolus (PIEB) administration. This novel drug delivery system provides small     boluses of local anesthetic and opioid at programmed intervals. Several studies suggest that     administration of PIEB allows a more extensive spread of local anesthetic in the epidural     space and provides superior labour analgesia compared to traditional continuous epidural     infusions. PIEB is associated with lower anesthetic consumption, a shorter second stage of     labour and greater patient satisfaction.      The authors are focusing on a PIEB setting known as the Next Bolus. Next Bolus (NB)     determines when the first PIEB bolus is given after the initiation of the epidural and     starting the PIEB pump. Currently we set this to be 15-45 minutes. In an attempt to optimize     resources, authors hope to determine the optimal NB interval that will provide adequate     analgesia but limit overall drug consumption. An optimally timed next bolus should minimize     drug costs and limit nurse and physician intervention by decreasing the need for manual     boluses.Increased local anesthetic consumption can cause undesirable side effects such as     itchiness, decreased blood pressure and motor blockade. By assigning patients to receive the     NB at 15, 30 or 45 minutes the authors hope to find the interval that provides analgesia     while minimizing side effects, improving patient safety. If the bolus is given too late then     there may be increased pain, less patient satisfaction, and the need for more analgesia in     the form of Patient Controlled Epidural Anesthesia or a manual bolus.The authors hope that     determining the NB will result in an institutional change to improve patient outcomes and     facilitate knowledge transfer. This information will be the first available research to help     guide other obstetrical centres using PIEB technology in determining the optimal NB interval.   "
18425|NCT03044379|"     Dapivirine Gel Rectal Safety and PK Study   "
18426|NCT03044366|"     Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of     rudimentary build, many medical and physical problems have shown in treatment of disease such     as complications, airway problems, temperature disregulation and deficient drug metabolism.     This retrospective study evaluates the perioperative management and postoperative course in     premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of     prematurity (ROP).   "
37405|NCT02796053|"     Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08     during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled     with current therapy.   "
18427|NCT03044353|"     The study is intended to evaluate whether monthly repeated courses of administration of     GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in     patients with cardiac amyloidosis, monitored by cardiac magnetic resonance imaging (CMR) and     echocardiography (ECHO), and whether this is associated with an improvement in cardiac     function. Cohort 1 is transthyretin cardiomyopathy (ATTR-CM) , cohort 2 is patients with     immunoglobulin light chain (AL) systemic amyloidosis at greater than 6 months post     chemotherapy, cohort 3 newly diagnosed AL systemic amyloidosis undergoing chemotherapy.     Primary objectives for the study are assessment of reduction in cardiac amyloid load after     repeated administrations of Anti-SAP treatment as evaluated by CMR in all study groups and     assessment of safety & tolerability of repeated administration of Anti-SAP treatment,     including compatibility with chemotherapy treatment in patients with AL systemic amyloidosis.     This is an open label, non-randomised, three-group, monthly repeat Anti-SAP treatment study     in systemic amyloidosis patients with cardiac dysfunction caused by cardiac amyloidosis.     Subjects will receive up to 6 courses of Anti-SAP treatment. Maximum total duration for a     subject in the study is approximately 18 months.   "
18492|NCT03043508|"     OBJECTIVES:      The primary objective of this study is to evaluate the effect of estrogen on the development     of the PNET in MEN1 patients.      The secondary objective is to evaluate the overall survival and disease specific survival in     patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor     in relation to their hormone status. The secondary objective is to evaluate clinicopathologic     features in relation to hormone status.   "
18428|NCT03044340|"     Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve     by crisis when the feet extremities become red hot and painful. There are several types of EM     but this study concern the adult primitive form. For a long time, the physiopathology was not     described but now we know that there is a vascular form, with microcirculatory dysfunction     and a neurologic form with small fibers neuropathy. The diagnostic of neurologic form is     based on clinical evaluation (DN4 questionnaire, UENS scale...) and an electromyography.     Thermotest, a medical device which measure the thermic sensitivity is used to quantify     neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to chloride ions     detect small nervous fiber in diabetic patients with good correlation with Thermotest.      The purpose of this study is to analyze the vascular side and the neurologic side on patients     consulting for Erythromelalgy.   "
18429|NCT03044327|"     The aim of this study is to further profile and develop the Lipopolysaccharide, endotoxin     (LPS) challenge models (both by instillation and inhalation) by investigating the utility of     various non-invasive monitoring methods.   "
18430|NCT03044314|"     This study will compare the clinical efficacy of inhaled iloprost as an invasive, selective     vasodilator in the cardiac catheterization laboratory in patients with pulmonary hypertension     to the gold standard of inhaled nitric oxide. It will also examine whether echocardiographic     estimates of response to inhaled iloprost can predict responsiveness to invasive vasodilator     testing in patients with pulmonary hypertension.   "
18431|NCT03044301|"     The aim of this study is to evaluate the performance of the ZENEO needle free device in     subcutaneous functioning limits (low performance limit and high performance limit) and for     intramuscular injections.   "
18432|NCT03044288|"     The study investigates the impact real output has on peristomal skin covered by a newly     developed adhesive and a standard adhesive   "
18433|NCT03044275|"     The study investigates the impact real output has on peristomal skin covered by a newly     developed adhesive with topfilm and a standard adhesive with a topfilm.   "
18434|NCT03044262|"     The study investigates the impact real output has on peristomal skin covered by a newly     developed adhesive and a standard adhesive   "
18435|NCT03044249|"     A ten-week study to assess MP-101 in the treatment of psychosis in participants with     Alzheimer's Disease, as compared to placebo.   "
18436|NCT03044236|"     To examine and compare the effect of a novel stretching technique and traditional stretching     on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject     satisfaction in overhead athletes with glenohumeral internal rotation deficits through a     randomized clinical study.   "
18437|NCT03044223|"     The present study focuses on patients with Pseudomonas aeruginosa (PSA) sepsis. The aim of     the present study is to find out whether the M1 (pro-inflammatory) or M2 (anti-inflammatory)     phenotype predominates in blood monocytes in critically ill patients with PSA-sepsis, and     whether the severity of sepsis and outcome is associated with distinct monocyte phenotype and     function.   "
18438|NCT03044210|"     Cockayne syndrome (CS) is related to defective DNA transcription and/or repair and belongs to     the family of Nucleotide Excision Repair. It is an autosomal recessive multisystemic disorder     characterized by mental retardation, microcephaly, severe growth failure with lipoatrophia,     sensorial impairment, cutaneous photosensitivity, dental decay, enophtalmios. The disease is     progressive causing severe impairments but there's currently no therapeutics for the disease.      Growth failure, feeding difficulties and lipoatrophia are prognostic keys of CS but     physiopathology is unknown.      According to preliminary assays, our goal is to test the hypothesis that cachexia is due to     hypometabolism. We also want to test the potential link between this basal metabolism     modification and mitochondrial dysfunction and somatotrope axis, and correlation between the     basal metabolism degree and global severity of the disease.   "
18439|NCT03044197|"     Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many     biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With     multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of     increasing the detection of detecting clinically significant prostate cancer (csPCa) while     decreasing the detection of non-significant PCa.   "
18469|NCT03043807|"     To assess the safety of treating men with oligometastatic prostate cancer with the following     therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant     androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control     with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to     oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation.     Androgen blockade will be the same throughout the course of treatment.   "
18470|NCT03043794|"     This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk     breast cancer.   "
18471|NCT03043781|"     This study evaluates the use of intermittent epidural boluses compared to continuous infusion     in maintaining epidural pain relief in labor.      The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in     both groups.   "
18440|NCT03044184|"     This study aims to explore the effectiveness of tranexamic acid (also known as trans amine or     TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the     acute phase.      METHODOLOGY      This will be a Phase III, parallel-group double-blind randomised placebo control trial.     Patients allocated to the control group will receive standard care for hemorrhagic stroke     according to the 2015 American Heart Association guidelines. Patients allocated to the     intervention group will receive, in addition to standard care, a loading dose of intravenous     TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.     Timing and dosing are in accordance to previous established study protocols. Patients in the     intervention group will only receive a single treatment course of TXA.      Study subjects will be identified by either the on-duty clinicians from the Department of     Neurosurgery of this institution or by the study investigators. Should the patient meet study     eligibility criteria consent will be obtained either from the patient or from his/her next of     kin. 1:1 block randomization will be performed by a remote internet randomization service by     accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to     100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then     followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution     infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will     have an equal volume of normal saline (0.9%) infused as a placebo. The patient and the     outcome assessor will be blinded to study group allocation.      The primary endpoint of this study will be to assess the percentage change in brain blood     clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and     at 1 week.   "
18441|NCT03044171|"     To investigate the effects of desensitizing agents on the dental bleaching process, testing     the hypothesis that they may prevent dental sensitivity.   "
18442|NCT03044158|"     The study proposes to conduct a pragmatic, parallel cluster-randomized trial with nested     mixed methods, health economic and modeling studies to evaluate the effectiveness,     implementation and costs of the intervention strategy relative to standard TB diagnostic     evaluation at community health centers that are part of Xpert referral networks in Uganda.     The effectiveness of the intervention strategy will be assessed using routine data collected     as part of mandatory reporting to the Uganda NTLP on consecutive patients who present to     participating health centers during the 2-year trial period and meet eligibility criteria.     Selected patients and providers who provide informed consent will also be surveyed,     interviewed, and/or participate in focus groups to identify reasons for its success or     failure across study sites (Aim 2), and to collect relevant cost data for cost-effectiveness     analyses (Aim 3).   "
18443|NCT03044145|"     This study consists of two projects:      Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and     9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician     feedback in a pre-pilot trial. The study team will first train clinicians in the CFI-EA by     reading over the CFI-EA treatment manual and practicing how they can use it in behavioral     simulations, and then check whether participants think they can do it (feasibility) and like     it (acceptability) through standard measures. Following this the study team will revise the     CFI-EA based on their feedback for the comparative open trial in Phase 2.      Project 2: The study team will test the revised CFI-EA against treatment as usual in a pilot     trial. 3 clinicians and 12-15 patients will be enrolled in each arm. As before, the study     team will first train clinicians in the revised CFI-EA by reading over the CFI-EA treatment     manual and practicing how they can use it in behavioral simulations. Then, the study team     will check whether participants think they can do it (feasibility) and like it     (acceptability) through standard measures, and in addition will also explore any initial     effects on communication behaviors among patients and clinicians and treatment engagement     based on treatment retention.      The specific aims are:      For Project 1:        1. To pretest the CFI-EA intervention in a mental health setting through a pre-pilot open          trial that explores communication mechanisms of action in terms of communication          behavior and cultural content, and        2. To revise the CFI-EA intervention based on patient and clinician feedback on its          feasibility and acceptability.      As real-world community stakeholders for whom the CFI-EA is being developed, patients and     clinicians can provide helpful perspectives on how the CFI-EA can help clinicians tailor     treatment plans around patient cultural views and treatment preferences to keep patients in     care. The CFI-EA will be revised around areas of maximal agreement among patients and     clinicians with the help of health disparities and communication experts.      For Project 2:        1. To test the revised CFI-EA's feasibility and acceptability among patients and clinicians          in a pilot open trial against treatment as usual, and        2. To explore the relationship between the revised CFI-EA's effects on patient-clinician          communication and treatment engagement.      The study team hypothesize that clinicians using the revised CFI-EA will show more positive     communication behaviors compared to clinicians delivering treatment as usual and that CFI-EA     patients will stay in treatment longer. Communication behaviors will be assessed through     communication analysis techniques such as the Roter Interaction Analysis System.   "
18444|NCT03044132|"     This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes     of DermACELL AWM in dermal regeneration.   "
18445|NCT03044119|"     The Primary Objectives of the present study are :        -  To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood          mesenchymal stem cells (PBMSCs) on implant stability.        -  To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood          mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on          implant stability.   "
18446|NCT03044106|"     Purpose: To conduct a pilot study of the effect of Cranial Laser Reflex Technique (CLRT)     compared with sham laser on hamstring muscle flexibility, strength, and pain pressure     threshold.      Participants: Active, young adults ages 18 to 35.      Procedures: In a single, blinded crossover fashion, subjects will complete three functional     hamstring tests after CLRT and after sham laser treatment. Subjects will also complete     questionnaires to assess their expectations and perceptions of the interventions.   "
18447|NCT03044093|"     Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion -     a Double Blinded Randomized Controlled Trial   "
18448|NCT03044080|"     Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated     use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in     three successive infiltrations at 6-month intervals, checking if the sustainability of the     effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).   "
18449|NCT03044067|"     Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This     condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a     female to male ratio of 3:1) over 50 years of age with low education level and low     socioeconomic status, living in rural areas. High direct medical costs and significant     indirect costs of this condition can't be ignored.   "
18450|NCT03044054|"     This study evaluates the efficacy and the safety of the HIFU for the treatment of breast     fibroadenoma.   "
18451|NCT03044041|"     The purpose of this study is to compare blood loss between using low dose (500 mg) and high     dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in     double-blind RCT   "
18483|NCT03043625|"     Background: Non-specific neck pain (NS-NP) is characterized by pain in structures located in     the region between the superior nuchal line and the spinal process of the first thoracic     vertebra, without association with any specific systemic disease provided by multifactorial     and/or little known causes.      Objective: The objective of the present study will be to verify the clinical effects of MV     through visceral nociceptive inhibition in NS-NP patients with functional dyspepsia.      Methods: In this study sixty NS-NP patients with functional dyspepsia (age: 18 and 50 years)     will be randomized in into two groups: visceral manipulation group (VMG) (n =30) and control     group (CG) (n =30). The VMG will be treated with visceral manipulation to the stomach and     liver wile CG received placebo treatment. The immediate effects and 7 days after treatment     will be evaluated through pain, cervical range, and electromyographic activity of the upper     trapezius.   "
18452|NCT03044028|"     The current standard for rehabilitation after TKA consists of guided exercise therapy for up     to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery     and rehabilitation are highly successful at reducing or eliminating pain experienced     preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee     range of motion are often worse than preoperative levels for as long as 6 months after     surgery and in some cases may persist for many years after that. Such quadriceps strength     impairments after TKA have been largely attributed to voluntary activation deficits and can     lead to a decrease in functional performance such as decreased gait speed, decreased balance     which can lead to falls, and decreased stair climbing & chair rise abilities.      Since therapy alone does not adequately restore or improve upon the preoperative functional     capabilities in a consistent and timely manner, it has been suggested that NMES used     adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle     activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag,     increase walking speed, and improve QFM strength, knee range of motion, and function.     However, NMES initiated one month after TKA did not lead to improved QFM strength or function     beyond the standard benefits gained from exercise alone, thus suggesting that the timing of     NMES application after TKA is important.      It has previously been shown that preoperative QFM strength is predictive of postoperative     function [6] but the benefit of prehabilitation remains in question. To date, there has only     been one pilot study assessing the benefits of NMES when initiated preoperatively. This study     only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES     usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to     assess the benefits of NMES both preoperatively and postoperatively in order to determine how     it will be most beneficial to TKA patients.   "
22368|NCT02992834|"     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric     Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant     or refractory CD19+ B cell lymphoma.   "
18453|NCT03044015|"     BACKGROUND Recent evidence has been published about the effectiveness for the secondary     prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.      AIM To assess the effectiveness of a primary care based intervention in the secondary     prevention of OF.      METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT)     level. Total study follow-up 3 years. Sample size 1800 patients.      DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary     care based intervention about lifestyle, diet and drug prescription, if needed, with an     intensive follow-up in the intervention PCT vs treatment as usual in the control branch.      ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will     be analyzed through Cox proportional hazard regression model stratified by age groups.      Outcomes :        -  new OF ratio in intervention vs control areas.        -  maintenance of the adherence to the pharmacological and non pharmacological          interventions proposed        -  assessment of cost-effectivity of the intervention   "
18454|NCT03044002|"     Controlled, multicenter, non-inferiority trial to compare the rate of access site     complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular     interventions.   "
18455|NCT03043989|"     This clinical trial is being conducted to recommend a safe and tolerable phase 2 dose of     docetaxel or cabazitaxel when combined with clarithromycin in men who have developed     castrate-resistant prostate cancer.      In the castrate-resistant setting, resistance to taxane therapy inevitably develops. Men who     develop resistance to taxanes have a very poor prognosis, and few treatment options.      It is believed that CYP enzymes contribute to docetaxel and cabazitaxel resistance in     metastatic prostate cancer, and this resistance can be mitigated through pharmacologic CYP     inhibition. In this study a potent CYP3A inhibitor, clarithromycin, will be co-administered     concurrently with either docetaxel or cabazitaxel, whose systemic metabolism is dependent of     CYP3A4, with the intent to overcome resistance to taxanes.   "
18456|NCT03043976|"     This study will collect information about physical activity in patients affected by pulmonary     hypertension, through a specific device that can be worn on the wrist, and which measures     daily step count. The purpose of the study is to demonstrate whether providing patients with     their daily step count can increase their levels of daily activity if they have some basic     targets to achieve. Investigators also wish to compare the effects of this approach in     increasing daily physical activity, with the benefit gained when a drug therapy for pulmonary     hypertension is initiated, in patients that have just been diagnosed.   "
18457|NCT03043963|"     The main purpose of this study is to learn about the influence of two different behavioral     interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the     mechanisms involved. There is research evidence that healthy sleep promotes heart-health and     may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be     influenced by sex. This research will compare two interventions that are each designed to     improve sleep health, and will investigate sex differences in response. The project includes     3 in-hospital stays with biological measurements to evaluate the underlying mechanisms     associated with the effectiveness of two different blood pressure lowering behavioral     interventions.   "
18458|NCT03043950|"     A safety and efficacy study of first line therapy with Vectibix® in combination with     irinotecan, 5‑fluorouracil, and folinic acid (FOLFIRI) to validate a prognostic score in     adult patients with RAS wild-type metastatic colorectal cancer in a real world setting     (VALIDATE)   "
18459|NCT03043937|"     The aim of this work is to demonstrate the variation of cardiac diseases among pregnant     ladies in our localities, detect maternal & fetal complications and to predict the risk     factors for poor maternal, fetal & neonatal outcomes   "
18460|NCT03043924|"     The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is     associated with transient microstructural and metabolic changes in the female hypothalamus     using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.   "
18461|NCT03043911|"     The investigator intend to perform an observational study, by adding Respiratory Rate     monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and     PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be     deactivated. Retrospective analysis of the observational data collected will be utilized to     evaluate the potential benefits of additional continuous respiratory rate monitoring.   "
18484|NCT03043612|"     The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce     post-stent placement pain and urinary symptoms in patients following ureteroscopy for     urolithiasis.   "
18485|NCT03043599|"     The purpose of the safety run in Phase I portion of this study is to confirm the recommended     Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic     radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard     treatment with 4-6 cycles of platinum-based chemotherapy.      The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free     Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic     radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of     platinum based chemotherapy.   "
18462|NCT03043898|"     This study addresses the question, how does sound propagate from a source in the chest to the     chest wall? Using sound recorded at the chest as a diagnostic technique has the advantage of     being non-invasive and non-radioactive, but compared to other techniques it cannot currently     differentiate well between different diseases. Our aim is to improve our ability to     differentiate between different diseases using sound recorded at the chest by improving our     fundamental understanding of mechanisms by which sound propagates through the chest.      Examples of conditions that could be diagnosed using audible lung sounds are bronchomalacia,     asthma, lung cancer, interstitial lung disease and chronic obstructive pulmonary disease. The     methodology of the study will be to place a sound source at a known location in the chest and     measure the acoustic response on the chest wall with a microphone array.      The sound source will be created by playing sound down the working channel of a bronchoscope     and located anatomically using direct imaging. By placing a sound source inside the chest we     will be able to generate an acoustic map of the chest and test the relative importance of     different propagation mechanisms. This will be an advance on previous work, which placed a     sound source at the mouth.      Subjects will be selected for the study by asking patients undergoing a bronchoscopy     procedure whether they would be willing to take part in the experiment in addition to their     standard procedure.      Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge.     The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease,     asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally     significant interventional bronchoscopy service.      A subsidiary part of the study will collect sound recordings from healthy volunteers and     patients with common respiratory diseases using the same microphone array. This is to create     a database of lung sounds and quantify inter-subject variability.      The study will last approximately 30 months.   "
18463|NCT03043885|"     Improved predictability and quality of bone healing after a tooth is removed is clinically     relevant, in that, it improves our ability to achieve successful implant placement at     edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized     clinically to improve bone healing and provide sufficient dimensions of bone to support a     dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this     application. PRF is a concentrated blood product attained from the patient's own blood     consisting of a natural bioscaffold with integrated growth factors capable of sustained     release. Once processed, PRF is implanted back into the patient at the wound or defect site     to encourage healing. The literature regarding PRF is currently dominated by heterogeneous     applications of PRF for reparative and regenerative therapies without a consensus of its     clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated     to ascertain its clinical efficacy in improving bone formation and alveolar dimensional     stability after tooth extraction. A classic bone grafting material used for this purpose,     freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to     PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of     PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to     promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.   "
18464|NCT03043872|"     This is a phase III, randomized, open-label, multicenter, global study to determine the     efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy     (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line     treatment in patients with extensive-stage small-cell lung cancer.   "
18465|NCT03043859|"     In Canada, there is a growing burden of type 2 diabetes (T2D). Approaches to implement     nutrition recommendations and promote sustainable eating behaviours are required. The     investigating research team developed an educational curriculum that includes practical     information about Eating Well with Canada's Food Guide, portion control and food label     reading. The research team also developed a cookbook, Pure Prairie Eating Plan which     translates the Canadian Diabetes Association Clinical Practice Guidelines into a practical     menu plan with recipes, grocery lists and cooking tips. These resources promote behaviour     change and skill development to independently manage diabetes. These resources have been     successfully employed in a clinical study trial conducted at the University of Alberta and in     a pilot project at the community (Pure Prairie Living Program -PPLP), and showed beneficial     effects in management of diabetes among participants. The objective of this study is to     implement and evaluate the PPLP in a community level, to promote healthy lifestyle among     people with T2D in the general community. To meet the study objective, 60 adult participants     with diagnosed T2D will be recruited from three different primary care networks (total of 180     participants) and at each site 30 participants will be randomized into the education     intervention (PPLP) and 30 will be the wait-listed controls (CON) receiving usual care. PPLP     participants will attend 5, biweekly education sessions and a grocery store tour scheduled     over a period of 3 months.The benefits of the lifestyle intervention on physiological     indicators (BMI, Haemoglobin A1C, blood lipids, blood pressure) and lifestyle choices     (adherence to dietary recommendations, self-efficacy and participation in physical activity)     will be examined.   "
18466|NCT03043846|"     This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate     the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e.     usual care) in patients with axial spondyloarthritis.   "
18467|NCT03043833|"     This study represents Phase II of a research program involving an international collaboration     with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive     behavior therapy for the treatment of anxiety and depression in French-speaking Canadians     from the Atlantic Provinces.      The primary objective is to establish the clinical efficacy of a French-Canadian self-guided     format version of the Wellbeing Course by conducting a randomized-control trial where an     experimental group will be compared to a waitlist control group. A secondary objective is to     demonstrate the course's acceptability through participants' satisfaction with the course.   "
18468|NCT03043820|"     There is increasing clinical and molecular evidence for the role of hormones and specifically     estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator,     raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older     adults. The present study will test the extent to which adjunctive raloxifene treatment     improved cognition and reduced symptoms in young to middle-age men and women with     schizophrenia.      154 patients with a schizophrenia spectrum disorder will be recruited in a multicenter     twelve-week, randomized, double-blind, placebo-controlled, parallel trial of adjunctive 120mg     raloxifene treatment in addition to their usual antipsychotic medications.      The investigators hypothesize that daily treatment with raloxifene 120 milligrams (mg) in     addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases     social and personal functioning and reduces health care costs, as compared to placebo.   "
18502|NCT03043378|"     The goal of this research study is to learn how frequently cancer patients in the Supportive     Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is     neither related to cancer nor its treatment and lasts beyond the normal tissue healing time     of 3 months.   "
18493|NCT03043495|"     A dose-ranging study to test various doses of Dexamethasone (2, 4 & 8 mg) to be used as an     adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial     plexus block to find the best balance between valuable effects (mainly duration of analgesic     Effect) and side-effects (mainly increased random blood sugar levels)   "
18494|NCT03043482|"     The purpose of the study is to evaluate the safety, tolerability, and PK following single and     multiple ascending dose administration of VS-105 in healthy subjects and patients with     chronic kidney disease stage 5D (CKD-5D) on hemodialysis.   "
18527|NCT03043053|"     This is a randomized, double blind, placebo-controlled study of the effects of intranasal     oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of     intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study     visits include screening to determine eligibility, a 2-part baseline visit, and visits every     2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose     of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine     assessments.   "
18472|NCT03043768|"     In Parkinson's disease (PD), alpha-synuclein accumulation in cutaneous autonomic pilomotor     and sudomotor nerve fibers has been linked to autonomic nervous system disturbances even in     the early stages of the disease. The investigators recently introduced a non-invasive     technique to assess autonomic adrenergic fiber function using the quantitative pilomotor     axon-reflex test (QPART). In the present study the investigators aim to assess the     association between alpha-synuclein mediated structural autonomic nerve fiber damage and     nerve function in PD, elucidate the role of neuropathy progression during the early disease     stages, and test reproducibility and external validity of pilomotor function assessment using     quantitative pilomotor axon-reflex test (QPART) and sudomotor function via quantitative     direct and indirect test of sudomotor function (QDIRT).      A prospective controlled study will be conducted in four sites (Dresden, Germany; Berlin,     Germany; Budapest, Hungary; Boston, USA). A total of 52 male and female patients with     idiopathic PD (Hoehn&Yahr 1-2) and 52 age- and sex-matched healthy controls will be     recruited. Pilomotor function will be evaluated after iontophoresis of phenylephrine on the     dorsal forearm to elicit a cutaneous axon-reflex mediated response (goosebumps). Silicone     impressions of the stimulated area will be obtained, scanned and quantified for pilomotor     muscle impressions by number, impression size and area of axon-reflex pilomotor erection     spread. Sudomotor function will be evaluated after axon-reflex stimulation via iontophoresis     of acetylcholine on the dorsal forearm. Stained sweat droplets will be captured using     repeated digital photography and will be quantified over time for droplet number and     axon-reflex spread. Sympathetic skin responses following deep inspiration will be analyzed     using skin conductance quantification. Testing and evaluation of autonomic and motor symptoms     will be performed at baseline, after 2 weeks, 1 year, 2 years and 3 years. Skin biopsies will     be obtained at baseline and after 3 years and will be analyzed for nerve fiber density and     alpha-synuclein accumulation.      The investigators expect that this study will unveil whether progression of autonomic nerve     dysfunction assessed via pilomotor and sudomotor axon-reflex tests is related to progression     of autonomic symptom severity and alpha-synuclein deposition in PD. Additionally, potential     applications of the used techniques include interventional studies evaluating     disease-modifying approaches and clinical assessment of autonomic dysfunction in patients     with PD.   "
18473|NCT03043755|"     Propose to evaluate efficacy of association between US guide parasternal block and pectorals     nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple     mastectomy).      All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will     be observed.      All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine     0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.      During surgery patients receive light sedation with continuous infusion of propofol      Will be observed:      Additional local anesthetic infiltration from surgeon. Pain at rest and during movement     quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.      Eventual side effects such as nausea/vomiting.   "
18474|NCT03043742|"     Assess the safety and effectiveness of stem cell application with regard to improvement in     regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization     (TMR) and stem cells.   "
18475|NCT03043729|"     Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI     will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 +     aflibercept (Arm B) followed by surgery.   "
18476|NCT03043716|"     Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and     maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy     on long-term outcomes.   "
18477|NCT03043703|"     Detecting mild forms of obstructive sleep apnea (OSA) easily and efficiently might help to     identify and improve care for patients suffering from wake reactions at night. The AirSense     10 for Her is able to detect respiratory effort related arousals (RERAs) through changes in     the flow of air. The algorithm of the AirSense 10 will be compared with scoring via     polysomnography (PSG). 129 patients shall be observed in a sleep facility under suboptimal     Treatment (i.e. low pressure) with positive airway pressure (PAP) therapy.   "
18478|NCT03043690|"     This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of     ammonium-succinate based dietary supplement. In both studies group 1 took the     ammonium-succinate based dietary supplement and the group 2 took placebo.   "
18479|NCT03043677|"     To characterize circulating DC subsets from healthy controls and IBD patients and to assess,     following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and     golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators     on both the GI production of soluble immune mediators and the mucosal capacity to alter the     recruitment capacity of circulating DC subsets. It is expected that such approach will     provide further information on the action mechanisms of such therapies on IBD patients,     allowing a better understanding of the pathophysiology of this disease and the identification     of tissue-specific therapeutic targets, thus avoiding collateral problems associated with     systemic immunomodulation.   "
18480|NCT03043664|"     This study is for patients with non-resectable, recurrent, or metastatic well or moderately     differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs).      The study will be conducted in two stages: 1) Safety Run-In and 2) Expanded Cohort.        1. Safety run-in: The first stage will include a safety run-in of 6 patients treated with          pembrolizumab 200 mg intravenous (IV) every 3 weeks and lanreotide depot 90mg          subcutaneous (SQ) every 3 weeks. Up to 6 patients at the Duke Cancer Institute will be          accrued at the starting dose level. If one or less subject meets treatment-related          discontinuation criteria (as specified in the protocol) during Cycle 1, then the study          will proceed to the second stage, Expanded Cohort.        2. Expanded Cohort: Patients will be treated with pembrolizumab 200mg IV every 3 weeks and          lanreotide depot 90mg SQ every 3 weeks as determined by the Safety Run-In Cohort.   "
18481|NCT03043651|"     This is an open-label study to evaluate the safety of continued therapy with oral     treprostinil in subjects who have completed Study TDE-HF-301. This study will provide     long-term, open-label data regarding the effect of continued long-term oral treprostinil     therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with     preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,     24, and every 12 weeks thereafter until either oral treprostinil becomes commercially     available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.   "
18482|NCT03043638|"     The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP)     combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in     the treatment of multiple adjacent gingival recessions (MAGRs).      12 patients with 84 Miller Class I or II recession defects were participated. Sites were     randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD),     recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root     coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical     attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively.     The data were analyzed statistically.   "
39059|NCT02774382|"     The purpose of the study is to investigate if treatment with fecal microbiota transplantation     or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent     Clostridium Difficile infections.   "
18495|NCT03043469|"     Dysfunctional breathing (DB) is a respiratory condition characterised by an abnormal     breathing pattern, among other complaints, that can occur either in the absence of other     pathophysiology (primary DB), e.g. anxiety-related factors, or secondary to cardiopulmonary     disease (secondary DB), e.g. asthma. As a consequence, patients may experience breathlessness     and present with periods of increased ventilation or erratic breathing, interspersed with     episodes of breath holding or deep sighs. In addition to respiratory symptoms, DB also     generates non- respiratory symptoms (e.g. dizziness and increased heart rate). It is     estimated 1 in 10 people in the United Kingdom (UK) have DB. However, DB remains poorly     understood, with no standardised approach to diagnosis and assessment.      The purposes of this study are:      Study 1) To identify physiological, functional and psychological characteristics of     participants with DB compared to healthy participants.      Firstly, symptoms, lung function, respiratory gas analysis, exercise capacity, respiratory     muscle function, respiratory motion, level of physical activity, quality of life and anxiety     & depression scores will be assessed in 20 participants with primary DB, 20 with secondary DB     and compared to 20 healthy participants.      Study 2) To develop an assessment tool based on physiological, functional or psychological     variables found to be different between any of the 3 groups in Study 1.      In order to do that, 54 people with DB (between primary and secondary) and 27 people     presenting with breathlessness secondary to restrictive lung disease will be assessed.     Analysis of these data will determine whether these variables can be used as a diagnostic     tool capable of distinguishing DB from restrictive lung diseases characterised by     breathlessness.      The recruitment period will be 1-2 years, with an individual participation of 9 days; 1-day     on site testing, plus 7-day home activity monitoring, and 1 day to return the activity     monitor (which will happen whenever the participant needs to return to the site).   "
18496|NCT03043456|"     In this research, the investigators are comparing the new thermoplastic material side by side     with the conventional poly methyl methacrylate for fully edentulous patients measuring their     satisfaction and microbiological count.   "
18497|NCT03043443|"     A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol     use disorder and sleep problems will be recruited and assigned randomly to the active     treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for     demographics. Sleeping problems will be the primary outcome of the study, and it will be     measured by the Pittsburgh sleep quality index (PSQI) scale.   "
18498|NCT03043430|"     Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric     patients requiring minor procedures in the Emergency Department setting. Patients will be     randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam     0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale     Preoperative Anxiety Scale (mYPAS).   "
18499|NCT03043417|"     This project is measuring the effectiveness of an anti-stigma intervention among primary care     providers. Both staff and clients will be asked to complete survey data in order to measure     the effectiveness. This is a randomized control trial in that three health centres will     receive the intervention and three will not. Results will determine if this intervention     reduces stigma among staff toward people with a mental health problem and/or substance use     problem.   "
18500|NCT03043404|"     To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter     aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis     who are considered high risk for surgical valve replacement.   "
18501|NCT03043391|"     The purpose of the study is to confirm the safety of the selected dose and potential toxicity     of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent     WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The     primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered     intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade     III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic     oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma     (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in     this population.   "
18503|NCT03043365|"     Background:      Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3     fatty acid is the most known fish oil available in the market. LCMUFA (long-chain     monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a     diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish     oil and understand it s effect on cardiovascular health.      Objective:      To understand the effects of LCMUFA from fish oil on cardiovascular health.      Eligibility:      Healthy volunteers ages 18 and older with no history of cardiovascular disease      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Fasting blood and urine tests        -  Optional stool sample        -  Questions about their diet, exercise, and the types of medicines and dietary supplements          they take        -  7-day food diary        -  Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The          heart is monitored.        -  After the screening visit, participants will take 4 gel capsules, 3 times a day after          meals, for 8-10 weeks.        -  Electrocardiogram (EKG)      Participants will have 3 additional visits. All include repeats of the screening tests.      Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for     8 weeks after this visit.      Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4     capsules, 3 times a day after meals, for 8 weeks after this visit.      Visit 4 is 8 weeks after starting the second supplement.   "
18504|NCT03043352|"     HYPOTHESIS:      Investigators hypothesize that by provision of care at household level in a community through     lady health workers will as effective (recovery rate, burden of SAM, cost effective,     coverage) as through health care providers at facility level. OBJECTIVES        1. To evaluate the effectiveness (rate of recovery, burden & coverage), of SAM standard          management of children 06-59 months delivered at household level by first level health          care providers (Lady health workers) compared with the standard CMAM program delivered          at health facility by Govt./ACF staff.        2. To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community          level versus treatment delivered at health facility by Govt/ACF staff.      STUDY DESIGN:      Cluster randomized controlled trial      SAMPLE SIZE & RANDOMIZATION:      Investigators took 6% prevalence to calculate the sample size with an expected reduction of     20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY     METHODOLOGY Intervention (Group A): LHWs will identify and treat all cases of severe acute     malnutrition (SAM) as per the study eligibility criteria (MUAC < 11.5 cm) and manage all     cases of SAM without complications at home following the national CMAM guidelines. Control     (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC < 11.5 cm) and will refer     all cases to the health facility (ACF) for further management and counselling by health     workers at facility.   "
18505|NCT03043339|"     This is a hypothesis-generating pilot study. The intent is to model the impact of     perioperative practices on the intestinal microbiome and possibly associate these conditions     with the final microbiome status (e.g., number of resistance genes and diversity associated     with perioperative practices and preoperative microbiome status). Participants will include     individuals who are having surgery to either receive or donate a kidney. To determine the     diversity change of the intestinal microbiota over time, rectal swabs will be collected     before surgery and at several time points after surgery, with the last swab collected 30 days     after surgery.      This pilot study is to obtain preliminary data to support the rationale and design for a     subsequent clinical trial. This study is designed to understand the intestinal microbiota     diversity in the setting of renal transplant surgery and the clinical significance of     antibiotic use and the associated resistome (collection of all antibiotic resistance genes     and precursors within a sample).   "
18506|NCT03043326|"     The purpose of the study is to evaluating the acceptability, use and adherence of a     pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil     fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth, at four health     facilities and one community-based organization providing health care services for MSM and     transgender women.      This is an Observational, longitudinal, multicenter, open-label study to evaluate the     acceptability, use and adherence to TDF/FTC-based PrEP in volunteer men who have sex with men     and transgender women at substantial high risk of acquiring HIV, who were prescribed for PrEP     , following the clinical guidelines to prevent HIV infection of the U.S. Centers for Disease     Control and Prevention (2014) and the World Health Organization (2015).      Follow-up: Participants will be followed for 96 weeks (approximately two years) after the     start of prophylactic treatment.      Implementation Target Population: Adults (≥18 years of age), without HIV infection diagnosis,     and who were prescribed with PrEP and have a substantial risk of acquiring HIV infection     according to the international guidelines for HIV prevention.      Sample Size: 1,000 participants      Implementation Sites:        1. Asociación Civil Impacta Salud y Educación, Barranco study site        2. Asociación Civil Impacta Salud y Educación, San Miguel study site        3. Asociación Civil Selva Amazónica, ACSA study site        4. Asociación Vía Libre, Vía Libre study site        5. Espacio Común, Epicentro study site      Primary Objectives:        1. Describing the acceptability and its socio-demographic and sexual behavior correlates          for the use of PrEP.        2. Evaluate the persistence of the use of PrEP and its correlates with risk behaviors        3. Evaluating the adherence to the PrEP using self-reporting and pill counts      Secondary Objectives:        1. Describing the changes over time in risky sexual behavior among study participants.        2. Describing the number of participants who acquire HIV infection.        3. Evaluate the deviation of the indication of use of PrEP through self- reporting of its          sale or sharing with third parties.   "
18507|NCT03043313|"     This is a phase II trial that will study how well tucatinib (ONT-380) and trastuzumab work in     treating patients with colorectal cancer with a specific genetic marker (human epidermal     growth factor receptor 2 - HER2) that has spread to other places in the body or has come back     and cannot be removed by surgery. Tucatinib has been found to specifically target and inhibit     HER2.   "
18508|NCT03043300|"     This prospective, observational pilot study is designed to assess feasibility, refine the     target population, and quickly test qualitative and quantitative changes in the microbiome     after short-term travel to South or Southeast Asia, regions where rates of travelers'     diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.      To measure the diversity change of the intestinal microbiota, participants will complete a     questionnaire and provide a stool specimen at three different time points: prior to     traveling, two weeks after returning from traveling, and 14 weeks after returning from     traveling.   "
18509|NCT03043287|"     This study is a retrospective chart review of patients treated with onabotulinumtoxinA     (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE)     cutoff ratios that predict post-procedure urinary retention requiring catheterization.   "
18510|NCT03043274|"     This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in     patients with ST-elevation myocardial infarction randomized to receive cangrelor during their     percutaneous coronary intervention and compares them to patients randomized to not receive     cangrelor.   "
18511|NCT03043261|"     EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility,     usability, effectiveness and relevance of an integrated psycho-behavioral intervention on     heart failure patients in order to increase support, outreach and general well-being of these     patients following hospitalization due to heart failure exacerbation.   "
18512|NCT03043248|"     This study comprises 2 cohorts, and in each cohort, the study will be conducted as an     open-label add-on study.      The purpose of the study is to investigate the pharmacokinetics of each substrate in     concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort     A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in     healthy adult males.   "
18513|NCT03043235|"     This research study will examine how ethnic/racial background, body composition (%body fat),     and the location of body fat affect the ability of the hormone insulin to promote uptake of     blood sugar in persons who are 19 to 45 years of age. When insulin is ineffective in     promoting blood sugar uptake, this condition is termed insulin resistance. Insulin     resistance plays a major role in the development of chronic metabolic diseases (such as type     2 diabetes, cardiovascular disease, and cancer), many of which differ with race. Previous     studies suggest that insulin resistance is higher in African-Americans (AA) vs.     European-Americans (EA). However, results from these studies remain unclear due to different     testing measures used for insulin resistance as well as differences in body fat between     individuals. Results from this research study may help explain why insulin resistance differs     with genetic background and may guide development of personalized treatment strategies with     implications for several chronic metabolic diseases (e.g., type 2 diabetes, cardiovascular     disease, and cancer).   "
18523|NCT03043105|"     To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP     regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.   "
18524|NCT03043092|"     Transcranial Doppler ultrasound is bedside tool use to assess cerebral blood perfusion in     critically ill patients. We sought to conduct a prospective, single centre study aiming to     determine whether chronic vascular diseases may be a confounder in transcranial Doppler     ultrasound assessment in critically ill patients.   "
18525|NCT03043079|"     Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess     ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using     shear wave velocity values measured with ultrasound will identify features of the abdominal     wall that differ between healthy volunteers and subjects scheduled to have ventral hernia     repair. Through the use of ultrasound including shear wave velocity measurements, the     abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to     those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia     affects abdominal wall elasticity and effect surgical outcomes.   "
18514|NCT03043222|"     For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues:     the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing     ability to maintain normal sexual activity and function; both issues are important to men,     yet often the treatment of the former has adverse effects on the latter. Current medical and     surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery     times, degradation of sexual function and incontinence may negatively affect a patient's QoL.      Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving     techniques with contrasting mechanisms of action (mechanical decompression vs angiographic     embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar     safety profiles. More importantly neither causes degradation of sexual function or urinary     continence. Although multiple studies are being reported on PUL and PAE alike, currently     there are no prospective clinical trials comparing these two technologies. We aim to     prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could     have a great impact on patient outcomes in men opting for minimally invasive, sexual function     sparing treatment options for symptom relief from prostate enlargement.   "
18515|NCT03043209|"     Investigators aim to use comparative exome and/or genome sequencing to discover causative     molecular lesions for phenotypes hypothesized to be caused by somatic mutations. For this     study, investigators have targeted hypertrophic cardiomyopathy.   "
18516|NCT03043196|"     The purpose of the present study was to evaluate the effects of subgingival delivery of     Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic     Periodontitis (CP) patients.   "
18517|NCT03043183|"     This study is a prospective, single-center, randomized controlled trial. The study protocol     was approved by the Ethics Committee at the First Hospital of Jilin University.The     perioperation nutritional status will be assessed in gastric cancer patients within ERAS     protocols.The ERAS patients were randomly divided into perioperational nutrition support     group and conventional pathway group . Inter-group differences were evaluated for nutritional     index,clinical recovery index, complications etc.   "
18518|NCT03043170|"     Background to the research Patients present to Emergency Departments (ED) with a spectrum of     illness, many of which are life- threatening. The body has the ability to compensate in the     early stages when things go wrong so that on the surface patients do not appear as sick as     they really are. Under-diagnosis of severity of illness leads to under-treatment, unnecessary     mortality, and unnecessary hospital costs. Earlier diagnosis and consequent treatment will     result in prudent healthcare, cost-benefit and better patient outcomes.      Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power     and peripheral pressures gives vital clues to the hidden seriousness of illness and is a     guide to better management. Few EDs in the world assess such haemodynamics. After evaluating     a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic     shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if     applied across EDs in Wales. However, before we can do that we need to strengthen our     understanding of haemodynamics, and of relevant protocols and non-invasive devices that help     us to acquire such information.      Study Design After ethics and institutional approval is obtained from we will conduct a     prospective, single-centre, cohort study on 354 adult patients with possible shock associated     with an acute illness or injury who present to the Emergency Department of the University     Hospital of Wales, and follow them up for 7 days. 354 is a credible number to confirm that     the strategy works.      Written consent will be obtained either from the patient or a relative wherever possible but     a waiver of consent apply to patients who, because of confusion, unconsciousness or severe     disability, may be unable to give consent. In these cases, consent will first be sought from     a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a     relative as soon as practically possible.      What you hope to discover      We expect to discover that:        -  Uscom variables predict 7-day survival and ICU admission        -  Uscom variables improve the detection and classification of shock        -  The LiPS definition can be improved.        -  The objective definition is better than doctors experience        -  Patients have a good experience and are satisfied with care   "
18519|NCT03043157|"     This is an adaptative study where each participant's rocuronium dose will depend on the     previous patient's response, being higher if it was not enough and lower if it was more than     enough.   "
18520|NCT03043144|"     Malnutrition is an important complication of advanced kidney disease and impairment in smell     and taste may affect nutritional status. This study will examine the association between     impairment in smell and taste and nutritional and functional markers among patients with end     stage renal disease, as well as risk factors for smell and taste impairment.   "
18532|NCT03042988|"     Patients with autonomic failure are characterized by disabling orthostatic hypotension (low     blood pressure on standing), and at least half of them also have high blood pressure while     lying down (supine hypertension). Exposure to heat, such as in hot environments, often     worsens their orthostatic hypotension. The causes of this are not fully understood. The     purpose of this study is to evaluate whether applying local heat over the abdomen of patients     with autonomic failure and supine hypertension during the night would decrease their     nocturnal high blood pressure while lying down. This will help us better understand the     mechanisms underlying this phenomenon, and may be of use in the treatment of supine     hypertension.   "
18521|NCT03043131|"     Metabolic acidosis is a frequent problem in cardiopulmonary bypass. The cause is poorly     understood, but it appears to be multifactorial. It is assumed to be result of hypoperfusion     with resultant lactatemia. And other theories include bicarbonate dilution to excessive     proton activity and diluting fluid.The main three contributors for the development of     metabolic acidosis are stress of anaesthesia, surgery and Cardio Pulmonary Bypass(CPB)     prime.Even after research discussion and debate, there is no agreement upon ideal prime.The     literature is extensive, comparing different types of colloids, colloids versus crystalloids,     synthetic versus organic, and inclusion of numerous additions in an attempt to make a grossly     unphysiological state the least disruptive to the body as possible   "
18522|NCT03043118|"     Studies have shown that when exposed to a variety of food and flavor options people tend to     consume more than when only one item is presented. This strategy has been used to increase     vegetable intake in adults and during snacktime in children. Increasing vegetable consumption     in children is important because higher vegetable intake has been associated with reduced     risk of disease and because vegetables can help prevent weight gain by lowering the energy     density of a meal. The purpose of this study was to investigate the effects of using herb and     spice blends to create flavor variety in carrots as a model vegetable in a laboratory test     meal. We predict that children will consume more vegetables and that the energy density of     the meal will be lower when a variety of seasoned carrots are presented in comparison to a     single flavor. A secondary goal of the study was to determine other influences that may     predict children's liking and intake of seasoned vegetables, such as previous exposure,     infant feeding practices, and genetic bitter sensitivity.   "
18528|NCT03043040|"     This is a multicenter controlled intervention study that aims to assess the efficacy of a     telephone follow-up program for the prevention of suicidal behavior in adults discharged from     general hospitals after a suicide attempt.      The hypothesis is that the implementation of this program is associated with reduced rates of     suicide reattempts in these patients and also with delayed reattempts in them.   "
18529|NCT03043027|"     Percutaneous nephrostolithotomy (PCNL) is a common endoscopic procedure performed for upper     urinary tract calculus disease. Despite being minimally invasive, it is associated with     significant postoperative pain, often necessitating inpatient hospitalization and narcotic     pain medications. Additionally, one of a number of catheters is often left protruding from     the access tract for a period of time following the procedure, adding to patient discomfort.     Attempts have been made to study peri-tubular or access tract analgesic installation, which     have shown promise.1-2 However, no studies, to our knowledge, have examined the use of     liposomal bupivacaine preparations in this regard. In this study we hope to prospectively     analyze the use of liposomal bupivacaine injected to the access tract site at the time of     PCNL and determine its effects on postoperative narcotic requirement and pain scores.      Patients presenting for PCNL will be randomized to either the liposomal bupivacaine or usual     care, which involves no injection of local anesthesia. Patients will then be followed during     their inpatient stay. Total narcotic requirement (in milligrams) and pain scores (using     Wong-Baker FACES rating scale) will be compared.3 Typical postoperative care and discharge     criteria will not change during the course of this study.   "
18530|NCT03043014|"     Surgical abortion is one of the most frequently surgery of women in the world. 43 millions     are annually performed in the world.      90% of the abortions are performed during the first trimester of pregnancy before 13 weeks.     Legal surgical abortion during the first trimester of pregnancy is a low risk intervention     with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 %     to 3.4 %.   "
18531|NCT03043001|"     Since memantine may not only inhibit overactivity of microglial cell, but also repair the     damaged neurons and neurogenesis through activation of astroglial cell and release of     neurotrophic factors, the investigators propose that the neurotrophic effect of memantine may     benefit neurodegenerative diseases including bipolar disorders (BP) and alcohol dependence.     In the current study, the investigator will investigate whether add-on memantine at a dose of     5 mg/day has a beneficial effect on BP comorbid with alcohol dependence.   "
18585|NCT03042299|"     The purpose of this study is to evaluate the bio-equivalence of a single oral administration     of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial     formulation in Japanese healthy adult male participants in an open label, 2-period,     2-treatment, cross-over design.   "
18533|NCT03042975|"     The contribution of genetic risk factors to the development of focal dystonias is evident.     However, understanding of how variations in the causative gene expression lead to variations     in brain abnormalities in different phenotypes of dystonia (e.g., familial, sporadic) remains     limited. The research program of the investigators is set to determine the relationship     between brain changes and genetic risk factors in spasmodic dysphonia (or laryngeal     dystonia). The researchers use a novel approach of combined imaging genetics, next-generation     DNA sequencing, and clinico-behavioral neurotesting. The use of a cross-disciplinary approach     as a tool for discovery of the mediating neural mechanisms that bridge the gap from DNA     sequence to pathophysiology of dystonia holds a promise for the understanding of the     mechanistic aspects of brain function affected by risk gene variants, which can be used     reliably for discovery of associated genes and neural integrity markers for this disorder.     The expected outcome of this study may lead to better clinical management of this disorder,     including its improved detection, accurate diagnosis, and assessment of the risk to develop     spasmodic dysphonia in family members.   "
18534|NCT03042962|"     Task-specific focal dystonias are characterized by selective activation of dystonic movements     during performance of highly learned motor tasks, such as writing or playing a musical     instrument. To date, there is only limited knowledge about the distinct neural abnormalities     that lead to the development of task-specificity in focal dystonias, which affect similar     muscle groups but result in different clinical manifestations, such as writer's cramp vs.     pianist's dystonia or spasmodic dysphonia vs. singer's dystonia. Our goal is to dissect the     pathophysiological mechanisms underlying the phenomenon of task specificity in isolated focal     dystonias using multi-level brain network analysis in conjunction with neuropathological     examination of postmortem brain tissue from patients with dystonia. Rather than viewing these     disorders as interesting curiosities, understanding the biology of task-specific activation     of motor programs is central to understanding dystonia.   "
18535|NCT03042949|"     An assesment of an optical system that measures blood pressure on the finger -Elfor 1 device.     The system is based on a small optical sensor that emits coherent light into the skin and     collects the reflected light from the red blood cells in the blood vessels in the skin under     the sensor. The sensor is able to detect the pulse wave and blood pressure can be measured.      The investigators plan to measure blood pressure with the new sensor in patients who are     attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to validate     the sensor.   "
18536|NCT03042936|"     The purpose of this study is to test the effectiveness of an out-of-school diabetes     prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2     diabetes.   "
18537|NCT03042923|"     The objective of this project will be to determine whether patients with a surgical diagnosis     of endometriosis have impaired intestinal permeability as compared with healthy controls.     This would suggest the presence of an environmentally triggered and intestinally mediated     association in the etiology of endometriosis. This would be a proof of concept trial to     establish whether there is in fact a relationship worthy of future research.   "
18538|NCT03042910|"     This study is designed to evaluate the effects of talazoparib on cardiac repolarization in     patients with advanced solid tumors with no available standard treatment options.   "
18539|NCT03042897|"     This pilot clinical trial studies exercise and diet intervention in promoting weight loss in     obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and     minimize the risk of gynecologic surgery related to being overweight in patients with     endometrial cancer.   "
18541|NCT03042871|"     The purpose of this study is to compare the efficacy (times of injection, change of visual     acuity and Cva/ I) and safety (macular visual function and choroidal thickness) of different     dosing of ranibizumab intravitreal injection (1+PRN vs. 3+PRN) in treating with pathological     myopia choroidal neovascularization (PM-CNV).   "
18542|NCT03042858|"     This will be a multi-center prospective observational study of all patients who undergo     laparoscopic pyloromyotomy. Subjects who have PPV will be followed up to just before their     18th birthday through annual phone calls or emails to determine the incidence and timing of     subsequent inguinal hernia.   "
18543|NCT03042845|"     The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional     Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary     angiography via the right transradial route. This is a prospective, randomized, two-centre,     study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible     for non-urgent coronary angiography, are randomized after successful cannulation of right     radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.   "
18544|NCT03042832|"     This study will test the effects of the Leadership and Organizational Change for     Implementation (LOCI) intervention in facilitating evidence-based practice (EBP)     implementation in substance use disorder (SUD) and HIV services settings. LOCI improves     implementation leadership and organizational support to develop strategic climate for EBP     implementation. Greater efficiency and effectiveness of EBP implementation will improve the     public health impact of evidence-based health and allied healthcare innovations and lead to     greater effectiveness of SUD and HIV services.      Project Terms:   "
18545|NCT03042819|"     This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in     patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study     is to determine how safe and tolerable the combination is, as well as the best dose of the     study drugs in this patient population.      Selinexor (also called KPT-330), works by trapping tumor suppressor proteins within the     cell and thus causing the cancer cells to die or stop growing.   "
18604|NCT03042052|"     Aims of this study were to assess the long-term outcomes of detrusor injection of     OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization     (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk     factors for failure.   "
26374|NCT02940483|"     The goal of this clinical research study is to establish the safety of direct administration     of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with     recurrent posterior fossa ependymoma.   "
18546|NCT03042806|"     Patients affected from Chronic Obstructive Pulmonary Disease (COPD) benefit from pulmonary     rehabilitation in terms of exercise capacity, symptoms and health-related quality of life     whereas the effect on physical activity is still not clear. Some studies have investigated     the effect of exercise training on daily physical activity. However, there is considerable     variability in study findings, data are discordant and the effect of exercise training on     physical activity is unclear. There are probably a number of reasons to account for this.      First of all, the choice of the method for evaluating physical activity. Although direct     observation, double-labelled water and calorimetry are considered the gold standard for     assessing physical activity, they are too time consuming and expensive to be used in large     population studies .The Physical Activity (PA) of patients with COPD can be assessed using     questionnaires. A variety of questionnaires exist that capture different aspects of physical     activity such as amount, type, intensity, symptom experience and limitations in the     performance of ''activities of daily life''. Up to now, it still does not exist an instrument     that evaluates the physical activity of COPD patients in Italian language that takes in     account Italian people' lifestyle. Since this is strongly influenced by the environment,     cultural and social conditions in which we live, it is essential to have an instrument     specifically tailored for the population under study.      Aim of this study is to validate the Maugeri Physical Activity questionnaire (MaPAct) in COPD     patients pointing to assess self-perceived physical activity.   "
18547|NCT03042793|"     Title: Vaccination with PD-L1 peptide with Montanide against multiple myeloma after high dose     chemotherapy with stem cell support. A phase I first-in-human study.      Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting     the immune checkpoint molecule PD-L1 to investigate the potential of vaccination against     PD-L1 as a possible anticancer target.   "
18548|NCT03042780|"     The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with     gastroenteropancreatic high-grade neuroendocrine carcinomas.      This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high     grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus     beyond first-line).   "
18549|NCT03042767|"     The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in     children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care     treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT).     Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in     treatment compared to placebo.   "
18550|NCT03042754|"     Early diagnosis can contribute to good treatment outcomes and isolate infection control.   "
18551|NCT03042741|"     Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical     trials. It has shown significant improvement in lipid profile in patients with overweight or     obesity   "
18552|NCT03042728|"     In this study the investigators hypothesize that the presence of a dog will provide     additional benefits above typical therapy for patients suffering from fibromyalgia.   "
18553|NCT03042715|"     This research study is evaluating a psychological intervention for caregivers of patients     undergoing stem cell transplantation.      Phase 1 will include a qualitative phase to refine the intervention to specifically target     the needs of caregivers      Phase 2 of the trial will transition to an interventional randomization clinical trial   "
18574|NCT03042442|"     The purpose of this study is to determine the interrelationship between cachexia, neural     invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to     identify the protein expression levels of Activin and Midkine in plasma of patients with     different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate     the possible correlation with diabetes, tumor size and tumor stage.   "
18554|NCT03042702|"     Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an     anti-proliferative p53 activator pharmacological class, for the treatment of cancer.     Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild     type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.      In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be     evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to     evaluate the pharmacokinetics of Kevetrin when administered to subjects with     platinum-resistant/refractory ovarian cancer.   "
18555|NCT03042689|"     This research study is studying a drug as a possible treatment for advanced myeloid     malignancies including AML (acute myeloid leukemia), MDS (myelodysplastic syndrome) and MPN     (myeloproliferative neoplasms)      The intervention involved in this study is:      -Regorafenib (Stivarga)   "
18556|NCT03042676|"     Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of     acute leukemias. The most important post-transplant complication is graft vs host disease     (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin     (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any     increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number,     NCT00678275). In the ATG_familystudy (prospective, randomised, multicenter study) a decrease     in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG     (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the setting     of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA     identical sibling donor after myeloablative preparative regimen. In particular, the GVHD     extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a     minimum follow up of 2 years from transplant. The investigators would like to evaluate the     longer term follow up of this study.   "
18557|NCT03042663|"     To evaluate the value of US-guided Stellate ganglion block for improving radial arterial     blood flow and peripheral perfusion in Septic shock patients on vasopressor support with an     indwelling radial arterial cannula, which can result in reduced incidence premature failure     of the catheter (due to vasospasm or thrombosis) and incidence of ischemic complications in     the cannulated arm.   "
18558|NCT03042650|"     The purpose of this study is to determine if Intensive Referral Intervention increases     motivation to quit cigarette smoking and quitting-related behaviors in probationers and also     to determine if Intensive Referral Intervention improves short-term substance use outcomes in     probationers with substance use disorder.   "
18559|NCT03042637|"     The management of steroid-resistant nephrotic syndrome (SRNS) remains a persistent problem     for investigators in part because of the wide array of pathogenic mechanisms that contribute     to these disorders as well as the lack of adequately powered, controlled trials. While     glucocorticoids remain the primary therapy for many forms of protein uric glomerular     diseases, prolonged use is associated with significant morbidities including steroid induced     diabetes, metabolic bone disease, and excessive weight gain.   "
18560|NCT03042624|"     This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of     atopic dermatitis (AD).      The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA,     Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to     the list of microorganisms with qualified presumption of safety compiled by the European Food     Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in     accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic     polymerase chain reaction.      Using a repeated-measure cohort design, the investigators have recently shown that the     administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was     associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD.      The present randomized, double-blind, controlled trial is aimed at testing whether the     fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing     SCORAD in children with moderate to severe AD using placebo as comparator.   "
18561|NCT03042611|"     The purpose of this study is to evaluate the clinical benefit and safety of Apatinib plus     Best Supportive Care in comparison to Placebo plus Best Supportive Care in patients with     advanced or metastatic gastric cancer   "
18562|NCT03042598|"     Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves     patient safety (avoiding hypoxia) during emergency rapid sequence intubation .   "
18563|NCT03042585|"     Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an     autologous transplant are likely to suffer a relapse because standard myeloablative     preparative regimens are unable to produce a cure. The majority of these participants do not     have a stem cell donor available, are too frail to undergo an allogeneic transplant, or     refuse an allograft. Historically these participants with high risk non-Hodgkin's lymphoma     have had a very poor outcome.      To take advantage of the low transplant related mortality associated with an autologous     transplantation, the investigators propose modifying the preparative regimen to make it more     effective without increasing toxicity. By increasing the dose of radiation while     administering the protective growth factor palifermin (Kepivance), the investigators hope to     decrease the risk of relapse without increasing transplant related mortality.      Three prospective randomized trials have studied different radiation schemes as a part of the     TBI and cytoxan preparative regimen prior to allogeneic transplantation for patients with AML     or CML. As a group these trials showed that higher doses of TBI in these older studies     decreased the risk of relapse at the expense of VOD, GVHD, and CMV. Three retrospective     studies have also postulated that higher dose radiation led to less risk of relapse.   "
18573|NCT03042455|"     This study was designed to establish the clinical evidence for effect of Robot-Assisted upper     arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of     subacute stroke patients.        -  Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive          Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to          conventional occupational therapy        -  Subjects : total 99 patients with stroke whose upper limb functions are impaired        -  Intervention : 4 weeks of therapy (5 days per week)        -  Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion          analysis        -  Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks          of intervention, 4) 4 weeks after end of intervention   "
18564|NCT03042572|"     The primary objective of this trial is to investigate whether intramuscular administration of     allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a     composite outcome of mortality, limb status, clinical status (Rutherford classification) and     pain score (visual analogue scale), in patients with no-option severe limb ischemia (SLI).      The investigators will conduct a double-blind, placebo-controlled randomized clinical trial     to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI, who     are not eligible for conventional surgical or endovascular therapies. The investigators     intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections     with either BM-MSC (30 injection sites with 5*10^6 MSCs each) or placebo in the lower leg of     the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome considering     mortality, limb status, clinical status (Rutherford classification) and changes in pain     score, will be assessed at six months.   "
18565|NCT03042559|"     To compare the effect of Protonics knee brace and Hamstring Resisted Exercise (HRE) on     anterior pelvic tilt, hip internal rotation and adduction, and knee pain in subjects with     Patellofemoral pain symptoms (PFPS) and examine the reliability and validity of self-report     patellofemoral disability index (PDI) as a measure of functional performance in subjects with     PFPS.   "
18566|NCT03042546|"     Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing     in these sub-segmental bone defects.   "
18567|NCT03042533|"     The investigators will compare the three methods of seating a tibial nail - Backslapping or     Backslapping with Dynamic Locking or Internal Compression.   "
18568|NCT03042520|"     Primary Objective:      To evaluate the long-term outcomes including liver related morbidity, mortality and     hepatocellular carcinoma (HCC) development as compared to those of historical control with     interferon(IFN)-based treatment.      Secondary Objective:        1. To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based          treatment.        2. To investigate the long-term outcomes of extrahepatic manifestations of the          sofosbuvir-based treated cohort as compared to their pretreatment status.   "
18569|NCT03042507|"     Analysis of data from the recently completed NIH Child Comprehensive Behavioral Intervention     for Tics (CBIT) study found a manualized behavioral treatment approach strongly superior to     psychoeducation/supportive therapy for reducing tic severity in 9-16 year-old youths with TS     or other Chronic Tic Disorders. Buoyed by the success of the NIH study, the research group     now seeks to extend and disseminate the CBIT treatment through the systematic adaptation of     the CBIT protocol for use across a broader range of ages and treatment settings.      The goal of the this project is to develop a downward extension of the CBIT therapist guide     and parent workbook for use in 4-8 year old children with chronic tics. The revised CBIT-JR     manual/workbook will be pilot tested in five children at each of the three study sites (UCLA,     UWM, Weill Cornell) in order to provide initial data regarding treatment feasibility and     acceptability as well as our ability to implement the new intervention, along with relevant     quality control procedures, consistently across sites. These pilot data will then be used to     seek R01 support for a larger controlled multisite trial examining the efficacy of CBIT-JR.      Although arguably more complex than a single-site design, we have opted for a multsite study     in order: 1) to take advantage of the established productive collaborative relationship and     collective expertise in childhood tic disorders and psychosocial treatment development across     our three sites, 2) to collect the proposed feasibility data in a much shorter period of time     than otherwise possible, and as noted above 3) to demonstrate the cross-site portability of     the treatment - which will be necessary if we are to obtain subsequent funding for a     larger-scale efficacy trial.   "
18570|NCT03042494|"     In recent years, the importance of the gut microbiota to human health has been demonstrated.     In adulthood, the microbial profile is relatively stable, yet can be transiently altered by     factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut     microbiota has been shown to differ in normal versus disease states including inflammatory     bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship,     there is intense interest in designing interventions that positively influence the gut     microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that     alter the colonic environment in favour of health-promoting bacterial species, such as     bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to     beneficially alter the microbial profile, there is a need to identify the dosing requirements     to positively modulate the gut microbiota. This study will test the effect of two doses of     prebiotic on gut microbiota taxonomy and diversity.   "
18571|NCT03042481|"     Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF)     are current recommended first-line antiviral therapies for chronic hepatitis B (CHB).     Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of     having a potent antiviral effect, and good tolerance without side effect. The long-term     safety and efficacy of ETV and TDF therapy had also been identified. However, poor durability     of the effectiveness after stopping NUC therapy are encountered in the majority of patients.     Previous study identified a high HBV relapse rate of over 50% in HBeAg- positive CHB patients     treated with lamivudine. A recent study investigating the post-treatment durability of ETV     showed that higher to 45.3% of the HBeAg-negative CHB patients happened a clinical relapse     within 1-year after stopping ETV therapy. TDF is another recommended first line NUC with high     potency and high genetic barrier. Although the efficacy of long-term TDF therapy had been     identified, there is lack of data regarding the off-therapy response in CHB patients with TDF     therapy currently. Only a small scale of patients treated with TDF were included in a recent     study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after     greater than 4 years of NUC therapy. In addition, the factors associated with off-therapy     response are also still uncertain.      The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy     ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria     of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse     including virological and clinical relapse in all and between patients with ETV and TDF     therapy, and to identify the predictive factors of relapse.   "
18572|NCT03042468|"     The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617     that can be given without severe side effects for advanced prostate cancer.   "
18576|NCT03042416|"     Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific     patient populations:        1. Pediatric patients with congenital hyperinsulinism        2. Pediatric patients with neuroblastoma        3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor        4. Adult patients with a clinical suspicion of Parkinson's disease        5. Pediatric or Adult patients with primary brain tumors      This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton     PET Centre.   "
18577|NCT03042403|"     This study aims to Analyze and compere the hemodynamic and respiratory variables before,     during and after the applying of technic as well as evaluate respiratory pressures generated     during applying of this same technic and correlate them with the effort noticed by device     user.   "
18578|NCT03042390|"     This is a retrospective observational study of patients who have taken a regimen containing     DRV / c at least 24 weeks prior to study initiation   "
18579|NCT03042377|"     The purpose of this randomized clinical trial was to evaluate the incidence of postoperative     pain after retreatment using different techniques. Patients whom need retreatment were     included. The presence of postoperative pain was assessed after retreatment cases at 1, 6,     12, 24 and 48 hrs.   "
18580|NCT03042364|"     This study investigates the impact of endometrial scratching on endometrial secretion, when     correlated to pregnancy.   "
18581|NCT03042351|"     Non invasive study to improve the urinary incontinence, through pelvic floor muscles     exercises   "
18582|NCT03042338|"     Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current     project is to develop and assess the feasibility, acceptability, engagement, and usability of     a novel, central executive (CE) working memory training intervention.   "
18583|NCT03042325|"     The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when     given as monotherapy or add on therapy in participants who are on standard care for     management of Type 2 Diabetes Mellitus (T2DM).   "
18584|NCT03042312|"     Studies will assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic     castration resistant prostate cancer.   "
18586|NCT03042286|"     To find out the pharmacokinetic and genetic risk factors involved in muscular side effects     (myalgia) associated with statin therapy. To learn better ways of identifying risk factors     associated with muscle side effects during statin therapy. To perform laboratory analysis to     identify factors predicting future outcomes. The genetic material, in combination with other     medical information and blood tests, will be available to researchers studying genetic and     other factors that contribute to myalgia caused in some patient population on statin     medication.      Patients on statin are selected for this study. This study will recruit 1500 subjects from     National heart Centre Singapore over a period of 2.5 years.      Participation in the full study includes the donation of genetic material. However, subjects     have the option of not having blood subjected to genetic analysis and still participate in     the study. In this case, blood samples will only be analyzed for the statin drug content.   "
18587|NCT03042273|"     This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm     study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in     preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).   "
18588|NCT03042260|"     The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective     in preventing serious infectious complications (those that require hospitalization or lead to     death) in patients with lupus erythematosus that receive intermediate or high dose steroids.   "
18589|NCT03042247|"     According to the most recent guidelines, total-body imaging techniques are an indispensable     element in the staging and post-treatment re-evaluation in patients with lymphoma.     Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is the     gold-standard for the assessment of the disease in these patients. The use of alternative     methods, without radiation, such as whole-body magnetic resonance imaging (MRI), could be a     valid alternative; this would result an advantage, considering the young age of the majority     of patients at diagnosis and the need to undergo to serial assessments. The recent     introduction of combined PET total body MRI (PET/MRI) offers the possibility to integrate     morphological information with the high resolution of MRI with the metabolic activity of PET,     through the uptake of FDG, for a more accurate definition of the extent of disease in     patients with lymphoma.   "
18590|NCT03042234|"     According to the literature, high-intensity interval training (HIIT) emerges as a potential     training strategy capable of promoting positive adaptations to the health of obese children     and adolescents, as it demands less execution time (less volume) and can be considered     motivationally, More attractive to this audience. However, few studies have adopted the     anaerobic threshold concept and high intensity interval cardiorespiratory training to     evaluate the oxidation of energetic substrates during and after physical activity in obese     adolescents with and without insulin resistance.      In this context, this study aims to analyze the effects of high intensity interval training     on lipid and glycemic profile, cardiorespiratory parameters, metabolism of substrates, and     functional capacity of obese adolescents with and without insulin resistance.   "
18592|NCT03042208|"     Research suggests that when one spouse loses weight, the other spouse does too. This study     will examine whether a ripple effect is observed in untreated spouses and children of     individuals participating in a nationally available weight loss program. Participants will be     randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month     waiting period. Participants and untreated spouses (and any children in the home) will be     assessed at baseline, 3, and 6 months.   "
18593|NCT03042195|"     The purpose of the study is to examine whether postoperative nutrition with endeavours of     100% coverage of the patient's estimated energy and protein needs, can reduce the incidence     of postoperative complications.   "
18610|NCT03041974|"     During storage, red blood cells (RBCs) undergo changes collectively termed Storage lesions.     these changes may have an impact of the outcomes of transfused patients. One of these changes     is the release of microparticles by RBCs and other blood cells types. The aim of the study is     to (1) quantify red cell- and platelet-derived microparticles in RBC concentrates, and (2)     evaluate the impact of transfused microparticles (MPs) on survival and post-transfusion     complications in critical care patients participating in the ABLE trial (ISRCTN44878718).   "
18594|NCT03042182|"     Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining     the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after     hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct     cancer each year. One-year survival is less than 25% and no effective and safe systemic     treatments are currently available. Last year the completion of open-label phase 2 trial     (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third     of Mongolian patients with advanced HCC had a favorable clinical response, including complete     remissions and with overall survival over 90% after 1 year. So far a few patients with CCA     were treated with V5, but it appeared that their response rate was somewhat inferior to     patients with HCC since two (both with hemochromatosis) out six patients died within 6     months. In one patient who had improved clinically, the improvement was correlated with     decrease in CA19-9 tumor marker, but no marker profile information is available in regard to     other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory,     they will be not very useful to patients with CCA. The goal of this project is to manufacture     an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from     donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This     clinical trial will be conducted in collaboration with the National Cancer Center.   "
18613|NCT03041935|"     Surgical intervention to treat undescended testis is a very common pediatric surgical     procedure, often performed using an inguinal incision or subscrotal incision approach.     Children who undergo orchiopexy can suffer from a significant degree of discomfort     postoperatively. The investigators are evaluating the effectiveness of an ultrasound guided     caudal-epidural (CE) block to an US guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block     in achieving post operative analgesia following a orchiopexy repair. It is hypothesized that     US guided IIG/IHG nerve block leads to more effective pain control post-operatively while in     hospital relative to an US guided CE block for orchiopexy surgery.   "
18614|NCT03041922|"     Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting     positions by using ultrasound device. the elasticity of fat and muscle tissues will be     measured.      May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to     continuous sitting.   "
18595|NCT03042169|"     Due to the late onset of symptoms, gastric cancer is frequently diagnosed at an advanced     stage and therefore in an incurable situation.      Standard treatment for these patients is palliative chemotherapy, combining 2 or 3 drugs     (Wagner et al) However chemotherapy efficacy remains insufficient, while exposing patients to     severe toxicity.      Taking into account the low complication rates of gastric surgery today, chemotherapy alone     therefore may not be sufficient for stage IV gastric cancer patients.      The purpose of palliative gastrectomy is to relieve the symptoms associated with cancer, to     prevent subsequent tumour complications which are likely to occur, and to improve quality of     life. In addition reducing the tumour burden, may be associated with a prolonged survival     time.      This study is designed as a multicentre trial. Patients with diagnosis of a primary stage IV     gastric adenocarcinoma who are willing to participate in the trial will be randomized to the     surgical (gastric resection with peri-operative chemotherapy) or the control (chemotherapy     only) group.      Primary objective will be overall survival and secondary objectives will be quality of life,     progression free survival, surgical related postoperative morbidity and mortality,     chemotherapy related toxicities, overall duration of hospitalization and number of     interventional palliative procedures   "
18596|NCT03042156|"     Immunotherapy includes a class of medication called checkpoint inhibitors, which are a     relatively new medication therapy for many types of cancer which are metastatic, meaning it     has spread to other parts of the body.Immune therapy medication may be given safely with     radiation treatment, and in rare cases it may even make radiotherapy more effective. When     radiation therapy is given in the palliative setting it is given to treat pain/discomfort     and not necessarily shrink or get rid of the tumour. Palliative radiotherapy may be given for     many reasons, but common examples include painful bone or liver tumours, brain metastases, or     symptoms from a chest tumour such as feeling breathless, cough, or bleeding. Palliative     radiotherapy is usually given in smaller amounts and less frequently than other types of     radiation therapy. Because checkpoint inhibitors are relatively new there is not a huge     amount of evidence looking at how patients respond when the treatments are combined, or in     which patients immune therapy may make radiation therapy even more effective. This study is     looking at the way patients who are on or about to start immune therapy and who have been     recommended for palliative radiotherapy, respond to the combination of these two treatments.      The purpose of this study is to describe the treatment outcomes in patients with cancer that     has spread who are managed with a combination of immune therapy medication and radiotherapy.     This research is being done because there is limited information about the outcomes of     combined immune therapy and radiotherapy treatment from a patient's perspective, but also in     terms of which patients may have a better response to combined treatment. In particular, the     study aims to describe how combined treatment affects cancer not only in the area where     radiotherapy is given, but also outside the part of the body that receives radiotherapy     (which is called abscopal effect).   "
18597|NCT03042143|"     Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of     fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive     Care Units and is associated with a high mortality and a high morbidity in those who survive.     There is a large economic burden with direct healthcare costs, but also indirectly due to the     impact on the carer and patient through the patients inability to return to full time     employment. There is little evidence for effective drug (pharmacological) treatment for ARDS.     There is increasing information that mesenchymal stem cells (MSCs) might be important in     treating ARDS. REALIST will investigate if a single infusion of MSCs will help in the     treatment of ARDS. The first step will be to first of all determine what dose of MSCs is safe     and then divide patients suffering from ARDS into two groups, one of which will get MSCs and     the other a harmless dummy (or placebo) infusion, who will then be followed up to determine     if lung function improves. If effective this may lead to further research to determine if     MSCs are effective in patients with ARDS. This project will also provide new information     about mechanisms in the development of ARDS leading, potentially, to other new treatments   "
18598|NCT03042130|"     Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be     randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The     control group will receive standard of care alone. The study will test for the effects of the     additional IV iron on the symptoms, clinical picture and quality of life of the treated     patients.   "
18704|NCT03040739|"     Acetabulum fracture are high energy trauma in young people as it can be the result of a     simple fall in elder people. This fracture generates an incongruity between acetabulum and     femoral head. So surgery is recognized as the best treatment even if technically difficult     because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .      The aim of the study is to evaluate the effect of peroperative navigation system on reduction     of the acetabulum articular surface   "
18599|NCT03042117|"     Cardiovascular disease is one of the leading causes of death in the United States and the     world. Many interventions relating to prevention have been emphasized as more risk factors     for this devastating disease are discovered. Periodontal disease is known to have a close     association with cardiovascular disease, but its role as a risk factor is still not well     understood. Inflammation is a driving force in both of these diseases, creating a potential     bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction     in the body, which may predispose or even directly contribute to atheroma formation in the     coronary arteries. In this study, the investigators will study the link between the     inflammatory state of the body and will search for a correlation with levels of coronary     artery disease and periodontal disease. Inflammatory markers such as high-sensitivity     C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG)     levels in the patient's blood will be analyzed and correlated to clinical attachment loss     measured via pocket depth measurement, the distance from the gingival margin to the base of     the pocket. A definitive link between these disease processes will allow preventive measures     to be taken earlier to prevent this lifelong disease.   "
18600|NCT03042104|"     This clinical trial is a prospective, randomized, controlled, multi-center study. Patients     will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with     the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or     not they are able to perform a treadmill stress test. Patients who have a positive stress     test will be followed in a registry to collect data on subsequent treatment and mortality, as     applicable.   "
18601|NCT03042091|"     This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with     or without polyethylene glycol work in reducing infection in patients undergoing elective     colorectal surgery. Polyethylene glycol, may draw water from the body into the colon,     flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole     hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to     give preoperative neomycin and metronidazole hydrochloride with or without polyethylene     glycol in reducing surgical site infection after colorectal surgery.   "
18602|NCT03042078|"     This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic     approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus     fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.   "
18603|NCT03042065|"     Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in     children presenting with acute moderate to severe asthma.   "
18605|NCT03042039|"     CareWell will enable the delivery of integrated healthcare to frail elderly patients in a     pilot setting through comprehensive multidisciplinary integrated care programmes where the     role of ICTs can foster the coordination and patient centered delivery care. Carewell will     focus in particular complex, multi-morbid elderly patients, who the patients most in need of     health and social care resources (35% the total cost of Health Care System) and more complex     interventions due to their frailty and comorbidities (health and social care coordination,     monitoring, self-management of the patient and informal care giver). ICT platforms and     communication channels that allow sharing information between healthcare and social care     professionals involved in the delivery care of these patients, facilitating their     coordination, increasing their resoluteness and avoiding duplicities when tackling patients´     diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based     platforms can improve the adherence to treatment, enhance self-care and increase patient     awareness about their health status , as well as, improve the empowerment of informal     caregivers, who usually take care of these patients.      According to this, it is hypothesized that the benefit of integrated care programmes based on     (1) integrated care coordination and (2) patient empowerment & home support pathways     supported by ICT is greater and essential for these patients. Care pathways will cut across     organisational boundaries and will activate the most appropriate resources across the entire     spectrum of healthcare and social care services available for both scheduled and emergency     care. CareWell aims to scale up the services in pioneer regions and share their approach,     learning from and supporting the other pilot sites which are at different levels of maturity     in respect to designing, developing and implementing new ways of providing integrated care     services.   "
18606|NCT03042026|"     We will compare the features of 3D stereophotography of acromegaly patients with that of     healthy people. We hope to develop a computerized model to help screening acromegaly patients     for early detection and treatment.   "
18607|NCT03042013|"     The purpose of the study is to evaluate long-term safety and tolerability of continuous     treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273     study which has completed, at a minimum, the primary analysis or have completed the     individual study evaluation period and for whom the investigator feels the subject may have     potential to continue to derive clinical benefit from treatment with ASP8273.   "
18608|NCT03042000|"     At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy     (NCRT) followed by radical surgery has become the standard of care for the locally advanced     mid/low rectal cancer, having been proved to substantially improve the local control of the     disease, whereas not being able to improve the long-term survival. According to present     clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal     cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent 5FU     based chemotherapy, followed by the radical resection of the tumor. After surgery, adjuvant     chemotherapy (ACT) is recommended for all these patients without considering the     postoperative pathological results. Recently, however, some authors proposed that different     strategy of combined modality therapy should be applied in different patients according to     their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the     basis of investigator's previous clinical practice and researches, investigators plan to     stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several     subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy     will be applied in different groups, at the aim of improving the overall therapeutic effects,     as well as reducing the treatment adverse effects.      This research consists of four trials.   "
18609|NCT03041987|"     This study aimed to explore underlying mechanisms of chronic kidney disease progression and     its association with adverse consequences. It will enroll approximately 5000 pre-dialysis     chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up     for at least 5 years. Questionnaires, anthropometric measures, laboratory tests, and     biomaterials will be collected at baseline and annually. The principal clinical outcomes of     the study consist of renal disease events, cardiovascular events, and death.   "
18783|NCT03039712|"     The primary purpose of the study is to meet the CMS mandated Coverage with Evidence     Development requirement in the National Coverage Determination for Leadless Pacemakers as     they apply to Medtronic Micra devices. The study uses administrative claims data of the     Medicare population implanted with single-chamber ventricular pacemakers   "
18611|NCT03041961|"     There is an increasing interest in the effects of various food derived polyphenols on     vascular function. Arguably the most well-established vascular benefits are attributed to     flavanols from cocoa beans and this has been supported by a successful health claim through     the European Food Safely Authority in 2012. Berry fruits are another rich source of     polyphenols that have vasoactive properties, and there is a growing body of research     exploring these effects in various berries (blueberries, cranberries, strawberries) and other     fruit products with similar polyphenol composition. A key (poly)phenol in berries and other     fruits believed to provide much of the benefit is anthocyanins. When given as an isolated     extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely     and in response to chronic consumption over 12 weeks.      Aronia berries are a native North American berry with high naturally occurring anthocyanins     among other polyphenols. Based on their polyphenol composition, there is growing interest in     the potential for Aronia berries to elicit health promoting cardio-metabolic effects.     Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may     improve blood vessel function.      Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts     of differing polyphenol dose on vascular endothelial function.   "
18612|NCT03041948|"     Surgical intervention to treat a inguinal hernia is a very common pediatric surgical     procedure, often performed using an inguinal incision. Children who undergo hernia repair can     suffer from a significant degree of discomfort postoperatively. The investigators are     evaluating the effectiveness of an ultrasound guided caudal-epidural (CE) block to an US     guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block in achieving post operative     analgesia following a hernia repair. It is hypothesized that US guided IIG/IHG nerve block     leads to more effective pain control post-operatively while in hospital relative to an US     guided CE block for inguinal hernia surgery.   "
18615|NCT03041909|"     This is an open label, single arm study which will enroll up to 16 subjects with SCD who     previously participated in the GBT440-001 study.      Dosing of study drug will be for 2 to 6 months, depending on subject's dose assignment in the     last administration of study drug in GBT440-001.      The primary objective of the study is to evaluate the safety and tolerability of up to a     total of 6 months dosing of subjects with SCD who participated in the GBT440-001 study.   "
18618|NCT03041870|"     Previous studies have already revealed the involvement of the serotoninergic system in the     social behavior process. For example, more serotonin (5HT) was found in dominant male adult     monkeys. Little is known about the serotoninergic implication in human's social behavior. The     project aims to clarify the role of the serotoninergic system in social behavior in relation     to the process of social hierarchical information. In order to determine how serotoninergic     system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us     to measure the brain activity and the serotoninergic transporter occupancy (using the     [C11]-DASB) at the same time. The current study aims to investigate whether serotonin     transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection     of social dominance in facial expressions or other measures of social information processing.     Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and     neuropsychological questionnaires will give at the investigator more information and allow to     investigate whether performance on social information processing is modulated by personality     trait and genotype.   "
18619|NCT03041857|"     The objective of this research project is to perform a comparative study on the in vivo     kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed     Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and     downhill walking by means of videofluoroscopy.   "
18620|NCT03041844|"     The purpose of this study is to evaluate the effect of low frequency, low intensity     ultrasound treatment on wound healing and health-related quality of life with a randomized     clinical trial of patients with venous ulcers or diabetic ulcers.   "
18621|NCT03041831|"     This qualitative study seeks to assess whether mobile health technologies are helpful for     older adults. It is the first in a series of four studies whose overarching goal is to     conduct a program of pilot research aimed at developing and evaluating a technology-assisted     wellness intervention for older adults with obesity who may or may not live in a rural area.   "
18622|NCT03041818|"     The purpose of this study is to develop healing riding algorithm applicable in rural riding     centers and to apply this to children with cerebral palsy.   "
18623|NCT03041805|"     The aim of the study is to make a validation of Caprini score in patients undergoing varicose     veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT,     radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify     patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit     from prophylactic anticoagulation.   "
18624|NCT03041792|"     This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,     methodology study to assess the effect of 6 weeks of liraglutide administration on food     intake in obese subjects.   "
18625|NCT03041779|"     To assess the prevalence of pain score for perineum pain following childbirth followed by     phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal     suppository in postpartum perineum pain secondary to perineal trauma.   "
18626|NCT03041766|"     The clinical trial phase 2a is designed to assess the safety of the active ingredient     (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49     years of age with a history of infection with intestinal and urinary schistosomiasis, living     in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in     the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in     adults is considered to be a preliminary step in safety before starting trials in children in     endemic areas to S. mansoni or S. haematobium, target population of the vaccine.   "
18681|NCT03041038|"     The ichthyoses are a group of lifelong genetic disorders which share characteristics of     generalized skin thickening, scaling and underlying cutaneous inflammation. There are no     therapies based on growing understanding of what causes the disease. However, there have been     recent discoveries of marked elevations in expression of interleukin-17A (IL-17A) and     IL-17-related cytokines in the skin of individuals with ichthyosis, which may explain the     inflammation. Investigators propose that IL-17-targeting therapeutics will safely suppress     the inflammation and possibly the other features of ichthyosis, improving quality of life.   "
18627|NCT03041753|"     Background: stroke is a major cause of death and disability. Intravenous thrombolysis and     mechanical thrombectomy are able to re-open occluded vessels and save the ischemic tissue     from death. However, recanalization of the occluded vessel may trigger activation of     detrimental molecular pathways and exacerbate blood brain barrier (BBB) disruption,     eventually determining hemorrhagic transformation (HT) or cerebral edema (CE), causing the     so-called reperfusion injury. There is increasing evidence that a number of factors     measurable as circulating biomarkers, particularly metalloproteinases (MMP), contribute to     reperfusion brain injury. Preliminary data show that BBB disruption can be traced in vivo by     Computed Tomography Perfusion (CTP) imaging. The aim of this study is to evaluate the effects     of circulating and imaging biomarkers in relation to reperfusion injury.      Methods: consecutive patients presenting with acute ischemic stroke in the anterior     circulation territory, scoring≥7 on NIHSS, candidates to intravenous thrombolysis or to     endovascular treatment, will be enrolled in one hospital centre. Circulating levels of pro-,     anti-inflammatory, immunomodulatory factors, metalloproteinases and their     inductors/inhibitors, factors of endothelial dysfunction and fibrin resistance to lysis will     be measured in blood samples taken from each patients pre-thrombolysis and 24 hours after     thrombolysis. Biomarker levels will be studied in relation to CTP measures of BBB     permeability and in relation to imaging signs of reperfusion injury after acute     interventions, such as hemorrhagic transformation and cerebral edema.      Results: enrollment started on October 2015. As of January 2017, 70 patients have been     included. Results are expected by the end of 2018 with an estimated sample size of 140     patients. Using a definite protocol, a prospective collection of data, and an adequate number     of patients assuring statistically powered data, this study will integrate clinical     information with imaging and biological factors involved in reperfusion injury after cerebral     ischemia.   "
18628|NCT03041740|"     The primary study objective is to assess the safety and feasibility of PFOB as a liquid     breathing medium for up to ten days in subjects with severe Bronchopulmonary Dysplasia (BPD).   "
18629|NCT03041727|"     The study purpose is to compare the effects of Fascial Manipulation added to standard     exercises protocol versus the simple exercises protocol.   "
18638|NCT03041610|"     A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically     inactive participants with chronic heart failure with reduced ejection fraction will be     randomly assigned to intervention or control arms.      The six-month intervention will consist of an individualized pedometer-based walking program     with weekly step goals, monthly face-to-face sessions with the physician, and monthly     telephone calls with the research nurse. The intervention will be based on effective     behavioral principles (goal setting, self-monitoring, personalized feedback).      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes     include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,     average daily step count measured by accelerometry, anthropometric measures, symptoms of     depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.   "
18639|NCT03041597|"     To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed     versus immediate loading, using abutments with the SynCone® concept for implant-supported     detachable dental prosthesis (ISDDP) in the edentulous upper jaw.   "
18640|NCT03041584|"     To assess implant outcomes, both clinical and radiological, in a randomized study on guided     implant placement after 3-year follow-up, compared to non-guided treatment.   "
18630|NCT03041714|"     Background:      Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic     tremor is when a person also has dystonia. Dystonia is a condition in which muscle     contraction causes changes in posture. Researchers do not fully know what areas of the brain     cause these tremors, or how the types differ. They also do not know what tests can identify     the differences.      Objective:      To look at differences between essential tremor and dystonic tremor.      Eligibility:      People ages 18 and older with or without tremor      Design:      Participants will be screened with medical history, physical exam, and urine tests. Those     with tremor will complete questionnaires about how tremor affects them.      The screening and study visits can be done on the same day or on separate days.      Participants will have 1 or 2 study visits. These include magnetic resonance imaging (MRI)     and tremor testing.      For MRI, participants will lie on a table that slides in and out of a cylinder that takes     pictures. Sensors on the skin measure breathing, heart rate, and muscle activity. This takes     about 2 hours.      Tremor testing will include transcranial magnetic stimulation (TMS), electrical stimulation     of the fingers, doing a movement task, and recording of tremor movements. For TMS, two wire     coils will be held on the scalp and a brief magnetic field will be produced. A brief     electrical current will pass through the coils. For the other tests, small sticky pad     electrodes will be put on the skin. Participants will move their hand when they hear a sound.     They will get weak electrical shocks to their fingers. These tests will take 3-4 hours.      Participants can take part in either or both parts of the study.   "
18631|NCT03041701|"     Background:      Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood. Two types are     embryonal RMS (ERMS) and alveolar RMS (ARMS). Dasatinib may block over-expression of a     certain enzyme. Ganitumab may block a certain growth factor, which might suppress tumor     growth. This drug combination may help slow tumor growth in people with ERMS and ARMS.      Objective:      To see if dasatinib combined with ganitumab is safe and shrinks or slows the growth of tumors     in people with ERMS and ARMS.      Eligibility:      People any age who have ERMS or ARMS that did not respond to previous treatment and who can     swallow tablets      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood, urine, and heart tests        -  Scans/x-rays        -  Tissue sample: This can be from previous surgery or biopsy.        -  Optional biopsy: A small piece of the tumor is removed with a needle.      Participants will be asked to co-enroll in another protocol.      Participants will get a drug interaction handout and wallet card that show what foods and     medications to avoid.      Participants will be treated in cycles. The first cycle is 35 days and the rest are 28 days.     Participants will take dasatinib by mouth daily. They will get ganitumab through an IV every     2 weeks. They will have a physical exam every 1-2 weeks, and urine and heart tests before     most cycles.      Participants will continue treatment as long as they do not have severe side effects or their     tumors do not get worse.      After ending treatment, participants will have a visit. This includes repeats of the     screening tests.   "
18703|NCT03040752|"     A randomized controlled double blinded study included 200 women with preterm contractions.     After successful arrest of contractions women were randomized into 2 equal groups: GI women     received nifedipine 20 mg tablets twice daily and GII women received Ritodrine 5 mg tablets     every 6 hours. The primary outcome was gestational age at delivery and the secondary outcomes     include episodes of recurrent preterm labor, mode of delivery, maternal side effects and     neonatal outcome   "
18632|NCT03041688|"     This phase Ib trial studies the side effects and best dose of murine double minute chromosome     2 (MDM2) inhibitor AMG-232 when given together with decitabine in treating patients with     acute myeloid leukemia that has come back, does not respond to treatment, or is newly     diagnosed. MDM2 inhibitor AMG-232 may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving MDM2 inhibitor AMG-232     together and decitabine together may work better in treating patients with acute myeloid     leukemia.   "
18633|NCT03041675|"     Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus     include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less     and less effective over time. Some study revealed that Moxibustion and Acupuncture are     effective in Paralytic ileus. Investigators try to find other treatment except of medicine.     Laser Acupuncture is a safe and non-invasive choice. This study is to evaluate effect of     Laser Acupuncture on Paralytic ileus.   "
18634|NCT03041662|"     This observational study of a national cohort of 600 Swedish PSC patients include yearly     MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions,     symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC     patients and provide future possibilities to evaluate biomarkers for prognosis and early     cancer detection.   "
18635|NCT03041649|"     The objective of this study is to compare two low profile balloon gastrostomy button enteral     feeding devices, both currently used as standard of medical care. The investigators aim to     compare family preference and rate of complications between the two devices in a prospective     cohort of children. This is the first step in comparing initial and long-term outcomes along     with the need for seeking medical advice for gastrostomy site-related complications.      The secondary aim of this study is to follow this population long term (4 years) to document     the prevalence of: granulation tissue, infection, skin breakdown, and how long the     gastrostomy tube balloon remains functional (does not lose water).   "
18636|NCT03041636|"     The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can delay, lower     the amount of therapy you may need in the future, or possibly eliminate the need for future     therapy in recently diagnosed CLL patients.   "
18637|NCT03041623|"     An objective of JIPS Registry is to examine disease prevalence of idiopathic interstitial     pneumonias (IIPs), considering classification, background, and diagnostic methods based on     American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory     Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the     ATS/ERS classification of 2002 and 2013.   "
18641|NCT03041571|"     A qualitative study assessing the impact of early narrative medicine practice on Medical     Honors Program (MHP) students' attitudes regarding patient-centered interactions, through     interviewing patients with chronic or life-limiting illnesses to obtain their illness     stories.      MHP students will develop a patient narrative for the patients interviewed. These narratives     will be edited by the patient, and, with the permission of the patients, may be published as     a collection of stories.   "
18642|NCT03041558|"     This project will evaluate the implementation and efficacy of a domestic violence     intervention module for parents receiving child welfare home visitation services.   "
18643|NCT03041545|"     Physical activity during chemotherapy has been shown to increase patient health and wellbeing     as well as improve outcomes in breast cancer patients. The primary aim of this project is to     determine the feasibility of incorporating wearable sensors into clinical care by having     breast cancer patients, undergoing chemotherapy, wear a commercially available monitor     (Fitbit) that tracks physical activity, sleep, and heart rate monitor.   "
18644|NCT03041532|"     Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the     Western world. The decrease in incidence and mortality by CRC in the population undergoing     screening has been observed. Colonoscopy is the recommended method for detecting tumors in     early stages, as well as identifying and resecting adenomatous polyps, which are the     precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence     and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does     not prevent right colon lesions in the same way as the left colon lesions, with most of the     interval cancers located in the right colon. Studies published so far show an increase in the     adenomas detection rate (ADT) in the right colon in a second visualization of this segment     and an increase between 2 and 10% if this second examination is performed with the proximal     retroflexion maneuver .Retroflexion is a safe maneuver in expert endoscopists. The aim of our     study is to evaluate the ADT in right colon by means of a second visualization by performing     proximal retroflexion or second frontal visualization at random in the CCR screening     population.   "
18645|NCT03041519|"     This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy     approach using Ensite NavX as the only imaging modality with conventional fluoroscopic     approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional     fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.   "
18665|NCT03041246|"     Pregnancy and vaginal delivery are considered as the main risk factors for damage to the     pelvic floor. There are various ways to measure the strength of the pelvic floor and to     evaluate functional problems. Manual mobilization of the pelvic floor is a well-known     treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and     exercise for improvement of pelvic floor function and strength. The aim of this study is to     analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function     and strength of the pelvic floor muscles as well as parameters presumed to be influenced by     the strength of the pelvic floor in pregnant women.   "
18666|NCT03041233|"     The purpose of this registry is to assess the performance and clinical effectiveness of a     combination of SJM mapping and ablation products in the treatment of subjects with atrial     fibrillation (AF).   "
18784|NCT03039699|"     The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in     the treatment of viral intestinal infections in inpatient children   "
18646|NCT03041506|"     Shoulder dislocation is the most common joint dislocation presented to the emergency room     (ER) and reduction by medical team is always needed. Shoulder dislocation and reduction are     often very painful and require some form of sedation, pain relief and muscle relaxation for     reduction maneuvers. Several sedation protocols for reduction maneuver are described in the     literature, and each institution is guided by its own protocol to optimize patient comfort     and safety. At the Tel Aviv Medical Centre (TLVMC) ER sedation with ketamine and midazolam     are the mainstay form of sedation for shoulder dislocation reduction.      Sedation is not without risk, it is time consuming for the medical staff, and need personal     supervision. Sedation under busy ER conditions can cause a burden to the medical team which     can end up in treatment insufficiency and patient safety failure.      Ultrasound (US) guided interscalene block (ISCB) for shoulder surgery was found to be an     effective method for perioperative analgesia. However, there is limited data on performance     of US guided ISCB for shoulder dislocation reduction and its comparison to other analgesic     modalities Both techniques (block and sedation) for shoulder dislocation procedure are being     performed for two years at the TLVMC, however no study was done to evaluate these two     analgesic modalities.      The current study compares sedation vs. US guided ISCB for the treatment of shoulder     dislocation in the ER at the TLVMC.      Study objective:      Comparison of two common analgesic methods, Sedation vs. US guided ISCB, for shoulder     dislocation reduction in our institution.      Study design:      This is a prospective, randomized, interventional, open-label study with two arms- Sedation     group and US guided ISCB group. The sedation will be conducted by the orthopedic surgeon who     is certified to perform sedation and the US guided ISCB will be conducted by a certified     anesthesiologist.      Primary outcome:      Time frame measured from the beginning of reduction procedure until readiness for dismissal     from the ER according to the physician decision.      Secondary outcomes [short list]:      Visual Analogue Score (VAS), patient satisfaction, complications, US guided ISCB and sedation     failure rate, overall reduction success rate, readmission rate to the ER, daily activity     level measured by Quick DASH (Disabilities of Arm, Shoulder and Hand) outcome measure.   "
18647|NCT03041493|"     The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that     we see in blood vessels of traditional cigarettes (TC) users. The investigators will also     enroll non-smokers as controls, against which they will measure changes in blood vessels in     TC and EC users.   "
18648|NCT03041480|"     To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2     level in systemically healthy Chronic Periodontitis subjects and healthy controls.   "
18649|NCT03041454|"     Despite advances in the conduct and reporting of traditional systematic reviews, current     evidence suggests that they are used infrequently by health care managers and policy makers     in decision making. Managers and policy makers have suggested that concise presentation     positively affects the use of systematic reviews. The purpose of this randomized controlled     trial is to assess the impact of a traditional systematic review format compared with the     innovative format on the ability of health care managers and policy makers to understand the     evidence in the review and apply it to a relevant health care decision making scenario.      The two end-user groups have different formatting needs and will therefore run 2 parallel     studies, randomizing each group separately. Once participants have consented to participate,     a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio).     Unequal block randomization will be used and allocation will be concealed through central     assignment. Outcomes assessors will be blinded and participants will be blinded to the     citation of the review so that the traditional version will not be easily accessible in its     original format from the relevant journal.      This study will be the first study to engage health care managers and policy makers in the     testing of formats for presentation of research evidence relevant to their needs. The results     of the project will help increase the uptake of systematic review results in health care     management policy decision-making, ultimately leading to informed decision making and     positively impacting the health of Canadians.   "
18650|NCT03041441|"     The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your     head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid     that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI)     techniques, and to determine whether changes in estimated ICP are seen after treatment of     this condition.   "
18651|NCT03041428|"     Mechanical ventilation, in spite of being a life-saving technique, can also induce lung     injury (VILI) mediated by an inflammatory response, thus having a profound impact in the     course of critically ill patients. Ventilatory strategies aimed to minimize this VILI have     reduced mortality rates. Patients suffering cardiogenic pulmonary edema may need venoarterial     extracorporeal oxygenation, at the same time they are being mechanically ventilated. The     objective of this study is to analyze changes induced by the use of utraprotective     ventilatory strategies in the inflammatory lung response of these patients and their impact     on outcomes.   "
18661|NCT03041298|"     Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic     Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from     September 2011 to December 2013. The aim of this study, which was conducted in accordance     with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to     generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in     Magnetic Resonance (MR) mammography.   "
18652|NCT03041415|"     While low-income midlife and older adults are disproportionately affected by chronic diseases     that can be alleviated by regular physical activity, few physical activity programs have been     developed specifically with their needs in mind. Those programs that are available typically     do not address the recognized local environmental factors that can impact physical activity.     This research aims to evaluate the added effects on two-year physical activity levels of a     novel citizen science neighborhood engagement program (called Our Voice) when combined with     an evidence-based, individually-focused physical activity program (Active Living Every Day),     relative to the individually-focused program alone. The programs will be delivered in     affordable housing settings, and represent a potentially scalable means for promoting     physical activity across broader income groups in the US.   "
18667|NCT03041220|"     Retrospective chart review using both out patient and inpatient records of obese patients     (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate     the patient's BMI, their skin incision type at time of c-section, their co-morbidities,     number of previous c-sections and post partum follow up for wound infection, wound separation     and wound breakdown. We will also review operative notes to evaluate blood loss, length of     surgery and complications during surgery. We will obtain maternal characteristics and     information about the pregnancy.   "
18668|NCT03041207|"     This is a prospective study with three specific aims: (1) To convene a consensus conference     to develop a guideline for antibiotic use in infants (age < 3 yrs) with suspected     ventilator-associated infection; (2) To evaluate outcomes before and after implementation of     the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course     of mechanical ventilation   "
18653|NCT03041402|"     Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and     cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted     Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal,     i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance,     improves patient-ventilator interaction. A specific setting to generate neurally controlled     Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators     here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood     gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony.      Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after     extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory     support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi     (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper airway     pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We assessed     EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime), pressure-time     product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds after initiation     of patient effort, patient comfort, inspiratory trigger delay (DelayTR-insp), and the rate of     asynchrony, as assessed by the Asynchrony Index (AI%).   "
18654|NCT03041389|"     The therapeutic options are limited in Parkinson's Disease (PD) patients with insomnia and     are often based on pharmacological treatments. It has been shown that the cognitive     behavioral therapy can be effective in primary insomnia. To the investigators knowledge, the     effect of computerized cognitive behavioural therapy on insomnia in PD has not been evaluated     before. The aim of this study is to demonstrate the beneficial effects of 6-weeks of     computerized cognitive behavioural therapy on clinical and sleep variables of insomnia in     Parkinson's disease patients.   "
18655|NCT03041376|"     A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically     inactive participants with chronic heart failure with preserved or mid-range ejection     fraction will be randomly assigned to intervention or control arms.      The six-month intervention will consist of an individualized pedometer-based walking program     with weekly step goals, monthly face-to-face sessions with the physician, and monthly     telephone calls with the research nurse. The intervention will be based on effective     behavioral principles (goal setting, self-monitoring, personalized feedback).      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes     include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,     average daily step count measured by accelerometry, anthropometric measures, symptoms of     depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.   "
18656|NCT03041363|"     To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of     triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed     with glucose transporter type 1 deficiency disorder (G1D).   "
18657|NCT03041350|"     Direct medical control using video conferencing capabilities of smartphones has never been     conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate     its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients     using a real-time smartphone video call.   "
18658|NCT03041337|"     The aim of this registry will be to compare the pathophysiological response of the morphology     and function of the right heart and pulmonary circulation assessed with resting and     stress-echocardiography in patients with various cardiovascular diseases, to compare them to     healthy individuals. The physiological response in healthy individuals as well as elite     athletes, defined as athletes participating at national and international competitions, will     also be evaluated. Patients will be enrolled both prospectively as well as retrospectively     and the will be evaluated by resting and stress echocardiography, which are part of the     routine clinical practice.      All clinical outcome measures will be collected as part of routine examinations. The     measurements will include systolic and diastolic pump function of the right and left     ventricles and other echocardiographic parameters. Moreover, a comparison of these parameters     among different groups will be performed. Other optional assessments will include: exercise     capacity assessed with 6-minute walking distance, World Health Organization functional class     (WHO functional class), peak oxygen uptake assessed by spiroergometry. Patients will be     evaluated at baseline and each year with the aforementioned procedures according to the sites     clinical routine.   "
18659|NCT03041324|"     The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and     plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913. SB-913 is an     intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts     a correct copy of the IDS gene into the Albumin locus in hepatocytes with the goal of     lifelong therapeutic production of the IDS enzyme.   "
18660|NCT03041311|"     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in     preserving the bone marrow and the immune system, and enhancing antitumor efficacy when     administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line     treatment for patients with newly diagnosed extensive-stage SCLC.      The study is a randomized, double-blinded, placebo-controlled design. The study will include     3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and     Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study     treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be     enrolled in the study.   "
18663|NCT03041272|"     The purpose of this study is to identify the incidence rate and characteristics of aggressive     behavior perpetrated by patients and visitors in inpatient medical units and to understand     the role of missed care events, professional quality of life and self-efficacy in     relationship to aggressive events.   "
18664|NCT03041259|"     A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of     Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia     Patients with Rutherford Class 4, 5 and 6 Disease   "
18669|NCT03041194|"     This is a pilot study on subjects who suffer from Interstitial Cystitis (IC) to assess the     dietary affects on urine pH in relation to their symptoms. The goal of this pilot study is to     determine which foods/beverages affect urinary pH and exacerbate patient's symptoms.   "
18672|NCT03041155|"     The research protocol is a Randomized Clinical Trial that has the effectiveness of a given     respiratory muscle training protocol over the indicative variables: Pulmonary function;     Markers of oxidative stress and inflammation, endothelial markers and Quality of life in     patients with chronic kidney disease undergoing hemodialysis. According to the Investigators,     this topic was proposed since it is known that several pulmonary complications occur as a     consequence of chronic kidney disease due to uremic myopathy. Therefore, the hypothesis is     that the application of a respiratory muscle training protocol will contribute positively     pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney     patients, consequently, will bring improvement in the quality of life for these patients. The     Patients will be divided into two groups: control group - No intervention of the Muscular     Training (CG) And Intervention Group (GI). The intervention protocol will be composed of     respiratory muscle training And lasts for two (2) months, with three (3) visits per week. It     will be carried out through Threshold PeP appliance. The twelve (12) first training sessions     will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmH2O and 15     minutes with expiratory load of 20 CmH 2 O; and the others (12) twelve sessions will last 40     minutes each, with 20 minutes with an inspiratory load of 20 CmH2O and 20 minutes with     expiratory load of 20 cmH2O. The variables evaluated will be: muscular strength Respiratory     (maximum inspiratory pressure and maximum expiratory pressure - Pimáx and Pemáx); Lung     function (Slow Vital Capacity - CVL, forced expiratory volume in the first minute - VEF1,     Vital Capacity Forced - CVF and Maximum Voluntary Ventilation - VVM); Serum levels of     oxidative stress markers, endothelial markers and endothelin.   "
18673|NCT03041142|"     Obesity has been considered as one of the primary factors for the development of pathologies     and cardiovascular risk factors. In the child it has been mediator for the development of     these comorbidities still in childhood, in the adolescence and more strongly in the adult     age, at the time of most cardiovascular events with death records. Objective: To analyze the     effects of an interdisciplinary intervention program on the cardiovascular risk factors of     overweight and obese children. Methods: It was conducted a physical activity program,     nutritional and psychological orientations, lasting ten weeks with overweighed children and     their mothers. Thirty-three children with BMI considered overweight and obese participated in     the study, they were divided into two groups, experimental (n=14) and control (n=19).     Physical activities occurred 3 times a week with children and once a week with mothers.     Nutritional and psychological counseling occurred once a week with both children and mothers.     BMI, waist circumference, waist-height ratio, percentage of fat, cardiorespiratory fitness,     systolic and diastolic blood pressure, lipid profile, glucose, left ventricular mass, daily     energy intake and parental perception of children's weight were analyzed. For the statistical     analysis it was first verified the normality of the data by the Shappiro Wilk test, with the     variables that presented normality the possible differences were verified through the Anova     test of mixed design with the post hoc of Bonferroni, for the normal variables, but that     presented significant difference in the initial moment of the research, it was resorted to     the Ancova, finally, for the non-normal variables the U tests of Mann Whitney and Wilcoxon.   "
18674|NCT03041129|"     The Investigators will measure if hepatic glucose metabolism is upregulated towards de novo     lipogenesis (DNL) via multiple intrahepatic pathways in obese girls with PCOS and hepatic     steatosis (HS), compared to PCOS without HS and obese controls without HS. HS will be     correlated to relative post-prandial hyperglycemia. Post-prandial hyperglycemia will be worse     or remain unchanged in youth treated with oral contraceptives and better with metformin.   "
18677|NCT03041090|"     PET (Positron Emission Tomography) images are used to help make patient management decisions     in staging and treatment assessment, often after a cancer diagnosis.      Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is     known as extravasation or infiltration, and it compromises the doctor's ability to read the     PET image. Often, the site where the tracer is injected into the vein (usually in the inside     of the elbow) are not in the images taken, so reading physicians are unaware that an     extravasation or infiltration has occurred.      Technology exists to capture time activity curves (amount of tracer in a location over a     period of time) during the PET tracer uptake period (usually once the tracer is injected, the     tracer circulates for 60 minutes prior to images), which can enable physicians to accurately     detect extravasations and infiltration. This information is currently unavailable to     physicians reading routine PET/CT (computed tomography) scans.      Time activity curves information gathered from these sensors during the circulation period     appear to match the brief pictures taken approximately 70 minutes after the tracer injection.      This study will determine if these time activity curves correspond to PET images of the     injection site taken during the tracer uptake period. If time activity curves correspond to     PET images, they can be used to determine if the tracer was properly injected. If there was     an improper injection, clinicians can be alerted to this fact and interpret the image with     this additional information.   "
18678|NCT03041077|"     Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the     most common site of joint discomfort regardless of age. Nearly half of people with knee joint     discomfort use natural supplements to alleviate symptoms, but more research is needed to     determine their effectiveness. In a previous study, we measured the effect of 8-weeks     ingestion of a commercialized joint support dietary supplement (InstaflexTM Joint Support,     Direct Digital, Charlotte, NC) compared to placebo on joint discomfort, stiffness, and     function in adults with self-reported joint discomfort. This study will be repeated using     Instaflex Advanced, with a longer 12-week time period. The Instaflex Advanced supplement     includes six products: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid,     and black pepper extract. This unique blend may improve joint function and increase mobility,     but has not yet been tested in humans using a randomized, double-blinded, placebo-controlled     research design. The primary purpose of this study is to assess the effect of 12-weeks     ingestion of the Instaflex Advanced supplement compared to placebo in improving knee function     in adults with self-reported knee joint discomfort.   "
18679|NCT03041064|"     This is a randomized, double-blinded, single-center, split body and split face, multiple     natural sunlight exposure evaluation of two marketed sunscreens under actual use conditions     in healthy volunteers. Eligible subjects will be randomized to two treatment randomization     groups: Left SPF (Sun Protection Factor) 100+/Right SPF 50+ or Left SPF 50+/Right SPF 100+.     Assessment of erythema and pigmentation will be performed at baseline and after all natural     sunlight exposure periods which will occur on at the same beach location over the course of 5     consecutive days. Subjects will be suspended from further natural light exposure periods     following the observation of sunburn at any exposed body site.   "
18680|NCT03041051|"     The purpose of this study is to determine the effect of a combined vaccination schedule of     the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine     (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.   "
18682|NCT03041025|"     GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis     (SSc), a rare autoimmune disease with high morbidity and mortality. Currently, there are no     approved disease modifying therapies and it is an area of high unmet medical need. GSK2330811     has been shown to bind and neutralize Oncostatin M (OSM) that has been associated with     fibrosis, vasculopathy and inflammation in a number of diseases. This multi-center,     randomized, double-blind (sponsor open), placebo controlled, proof of mechanism study will be     the first study to evaluate the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) of repeat subcutaneous (SC) doses of GSK2330811 in male and female     participants with diffuse cutaneous SSc (dcSSc). Participants with active disease and a     disease duration of <= 60 months will be enrolled. Approximately 24 to 40 participants will     be randomized across two sequential cohorts. Cohort 1 will evaluate a repeat-dose predicted     to provide sub-maximal inhibition of OSM, leading to a dose escalation decision. Cohort 1 is     planned to consist of at least 4 participants, randomized such that 3 participants will     receive GSK2330811 100 milligram (mg) and 1 will receive placebo. Cohort 2 is planned to     consist of at least 20 participants, randomized such that participants will receive     GSK2330811 300 mg and placebo in a 3:1 ratio respectively. The duration of the study is up to     34 weeks including a screening period of up to 6 weeks, treatment period of 12 weeks and     follow-up period of 16 weeks.   "
18683|NCT03041012|"     To evaluate the effect of early viral reactivation by latency reversing agents (LRA) and/or     administration of potent broadly neutralizing antibodies (bNAb) on the size of the latent     HIV-1 reservoir in treatment naïve HIV-1 patients initiating antiretroviral therapy (ART)   "
18684|NCT03040999|"     The purpose of this study is to determine the efficacy and safety of pembrolizumab given     concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in     participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The     primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in     combination with CRT with respect to event-free survival (EFS) per Response Evaluation     Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).   "
18685|NCT03040986|"     This phase II trial studies how well selumetinib sulfate works in treating patients with     pancreatic cancer with KRAS G12R mutations that has spread from where it started to nearby     tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
18687|NCT03040960|"     The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery     is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.     The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and     risk factors of these infections in a french University Hospital.   "
18688|NCT03040947|"     The purpose of this study is to develop imaging protocols when using cardiovascular magnetic     resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The     National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to     support the numerous investigator initiated projects in patients with various cardiac     pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be     shortened for patients with underlying cardiac diseases.   "
18689|NCT03040934|"     This study is a prospective, multi-center, open-label, randomized controlled clinical     trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting     coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™)     comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects     with total coronary occlusion lesion(s).   "
18690|NCT03040921|"     This prospective nonrandomized multicenter phase I study, will evaluate the feasibility of     performing uterine transposition before chemoradiation for rectal cancer and uterine     reimplantation after the treatment.   "
18691|NCT03040908|"     The 6-minute walk (6MWT) test is used in adults and children affected by a wide range of     chronic diseases to evaluate their sub-maximal exercise capacity. It reflects the global     response of various physiological systems (respiratory, cardio-vascular, neurologic,     metabolic and musculosquelettic) in a situation simulating a daily life activity. In children     with sickle cell disease, the 6MWT is correlated with a low level of hemoglobin, a low level     of fetal hemoglobin and low red cell deformability. Our team previously reported that in a     population of children with sickle cell disease, highly treated with hydroxyurea, the sole     factor which was independently linked to the 6MWT was the presence of silence infarct.      As the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly     correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of     endothelial and inflammation parameters and new hemolysis markers and b) if the presence of     silent infarct and the 6MWT are correlated with this biological markers.      This cross-sectional study will include sickle cell disease patients regularly followed for     more than 5 years at Hôpital Universitaire des Enfants Reine Fabiola, Centre Hospitalier     Universitaire (CHU)-Brugmann, Centre Hospitalier Etterbeek-Ixelles, CHU Saint-Pierre,     Cliniques Universitaires Saint-Luc (Bruxelles, Belgium). Inclusion criteria are: sickle cell     disease (SS, Sbeta°, SC, Sbeta+), age range : 6 to 25 years, signed informed consent.     Exclusion criteria are: transplanted patients, inability to perform the 6MWT (severe     cognitive disability, femoral osteonecrosis with functional impairment), hospitalization and/     or transfusion in the last 3 months for acute event.      Demographic data and clinical data will be retrospectively recorded. Blood test and 6MWT will     be performed in steady state. Studied analysis will be: coagulation factors, free hemoglobin,     Pro-B type natriuretic peptide (Pro-BNP), High sensitivity C reactive protein (HS-CRP),     Intercellular Adhesion Molecule (ICAM), Vascular Cell Adhesion Molecule (VCAM) and Selectins.      With this study, the investigators expect to validate new predictive markers for     cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop     these complications.   "
18692|NCT03040895|"     This study evaluate if a parental guidance programme based on the International Child     Development Programme (ICDP) offered to the general Norwegian population, has an effect on     caregivers, the relationship between caregiver and child, and on children's Development.   "
18693|NCT03040882|"     The post-operative treatment of pediatric patients operated for the correction of flat foot,     sees today the use of preformed leg-foot splint (Walker) as an alternative to the application     of plaster casts. The change of the immobilization system has led to the appearance of     problems of tolerability in particular in the skin. The problems persist also after placing a     polyurethane foam dress at the heel in the immediate postoperative period. The aim of this     study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in     children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous     lesions.   "
18785|NCT03039686|"     This is a multi-center, randomized, double-blind, placebo-controlled study to assess the     efficacy, safety and tolerability of two different weekly doses of BMS-986089 in ambulatory     boys with Duchenne Muscular Dystrophy (DMD).   "
18694|NCT03040869|"     Coronary heart disease (CHD) is the leading global cause of human death. Over the past     decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the     progression of clinical research and development of technical means and the mortality of CHD     has decreased by nearly 50% in western countries [1]. However, there are surveys shows that     with the improvement of living standards and changes in lifestyle, the incidence of CHD is     still rising in China and other developing countries, and the prevalence trend is obvious     younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less     than or equal to 45 years. Compared with other age-group CHD, young CHD has the following     characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and     incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary     syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two     extremes often exists in coronary lesions: mild or no atherosclerosis and severe     triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in     the same site repeated after interventional treatment, rapid progress of lesion in     non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or     bypass surgery, but the rate of revascularization is significantly higher in following 10     years.   "
18695|NCT03040856|"     Omega-3 fatty acids are good fats, and are among the most important nutrients lacking in     Western diets today. The average person in developing countries consumes less than 100 mg of     DHA daily. With increasing awareness of the importance of DHA, many people realize that they     need to make a change in their diet by adding DHA-rich foods or supplements.      The aim of this study is to learn the effect of different supplementations from the omega 3     group on the maternal and fetal fatty acid profile during pregnancy and to study their     epigenetic influence.   "
18696|NCT03040843|"     Altered mental status (AMS) is common in older patients. However there is a lack of     standardization in the definition and documentation of this compliant. Different perception     of AMS can cause negative impact on interpretation and obtaining scientific data. Although     definition of AMS is so complicated, clinical documentation can be detected in these patients     with AMS.   "
18697|NCT03040830|"     The study aims to know whether starting progesterone luteal support in intra cytoplasmic     sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of     embryo transfer compared with starting luteal support on day of embryo transfer   "
18745|NCT03040206|"     This study is to investigate the prognostic significance of enhanced International Prognostic     Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal     peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL     patients.   "
18698|NCT03040817|"     Diabetic gastroparesis, postsurgical gastroparesis, idiopathic gastroparesis and primary     pyloric stenosis are debilitating gastrointestinal motility disorder. However, there is     limited medical therapeutic options for these diseases. Gastric peroral endoscopic     pyloromyotomy (G-POEM) is an emerging novel endoscopic technique which is reported as a     minimally invasive therapy. But so far, the efficacy and safety of G-POEM on these diseases     are rarely explored. So, there is a cooperative group composed of five clinical centers for     clinical research in G-POEM.   "
18699|NCT03040804|"     To establish the safety of radiotherapy in the treatment of advanced hidradenitis     suppurativa. Patients will receive radiotherapy treatment over one week and then they will be     followed for the next three months.   "
18700|NCT03040791|"     Prostate Cancer (PC) is the most frequent cancer in men, accounting for 21% of new cases of     cancer in men in the United States. Among the four most incident tumors (breast, lung and     colorectal cancer); prostate cancer is the only that does not have any predictive biomarker     to guide the treatment. Even though the molecular heterogeneity of PC is well-documented,     treatment has not been molecularly stratified and the need for genetic prognostic and     predictive markers is critical.      DNA repair defects (DRD), mainly in the Homologous Recombination (HR) pathway (such as BRCA1,     BRCA2, ATM and CHEK2) are emerging as potential biomarkers in prostate cancer. It is well     known BRCA1 and BRCA2 carriers have better Progression-Free Survival (PFS) and Overall     Survival (OS) than non-carriers in ovarian cancer. Differently than ovarian tumors that BRCA     mutations provides a good prognosis, PC patients who harbor HR defects have a higher Gleason     score 6, an increased risk of recurrence and poor prognosis. The predictive role of DRD in PC     was demonstrated in a recent trial using Olaparib, a PARP inhibitor, in DRD carriers. This     trial showed 88% of response rate with Olaparib, a PARP inhibitor that acts in HR pathway by     synthetic lethality.      Recent data demonstrated important association between HR deficient high-grade serous ovarian     cancer (HGSOC), high neoantigen load and high expression of PD-1/PD-L1 compared with HR     proficient HGSOCs 10. This study showed that BRCA1 and BRCA2 mutations increase the number of     tumor-infiltrating lymphocytes (TILs) and confer a better prognosis. The unprecedented     success of immunotherapy in malignant disorders has provided evidence that the patient's     immune system can be improved to attack established tumors, mainly melanoma, non-small cell     lung cancer and kidney cancer. A high mutational burden increases the likelihood of the     development of specific neoepitopes that would confer clinical benefit from CTLA-4 and PD-1     blockade.      These data showed that specific DNA repair defects increase the mutational burden, the     expression of PD-1/PD-L1 and TILs; and could improve the response to immunotherapy in cancer.     This rationale was already tested in a trial that evaluated the PD-1 checkpoint inhibitor     Pembrolizumab in mismatch-repair deficient patients, a kind of DNA repair defect by     definition. This important trial showed that this DRD predicted clinical benefit of immune     checkpoint blockade in many types of cancer, especially colorectal cancer.   "
18701|NCT03040778|"     The overall purpose of this project is to answer the following clinical question: Among     Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with     the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to     those treated with standard of care alone, have decreased areas of exposed bone after one     year of treatment?   "
18702|NCT03040765|"     This study is to compare the two medications Denosumab and Zoledronic Acid For Patients With     Beta Thalassemia Major Induced Osteoporosis. Patients with B-thalassemia major induce     osteoporosis will undergo baseline assessment of the bone densitometry by Dual-energy X-ray     absorptiometry scan as a standard of care by the radiology department, then a blood test for     bone specific Alkaline phosphatase and type-1 Carboxy Telopeptide will be measured by the     chemistry lab.      Patients with B-Thalassemia Major induced osteoporosis, who are 18 years of age or more and     willing to participate in the study will be enrolled after consenting by the primary     investigator in hematology outpatient clinic. Patients with osteoporosis will receive one of     the two medications, at the end of the year Dual-energy X-ray absorptiometry scan will be     done to compare the response of the two medications. The potential risks include the     drug-related side effects   "
18892|NCT03038282|"     The effect of Chromium to improve glucose levels in Alzheimer Disease (AD) is controversial.     The hypothesis of the study is to evaluate the effect of supplementing the AD individuals     with Chromium combined with exercise and assessing the effect of the supplementation on     glucose metabolism.   "
18705|NCT03040726|"     The goal of this clinical research study is to learn if netupitant/palonosetron can help to     decrease chronic nausea and vomiting in patients with cancer. The safety of the study drug     will also be studied.      Some participants will receive the study drug and some will receive a placebo. A placebo is     not a drug. It looks like the study drug but is not designed to treat any disease or illness.     It is designed to be compared with a study drug to learn if the study drug has any real     effect.   "
18706|NCT03040713|"     This study is designed to assess the usefulness of 18F-AV-1451 in Positron Emission     Tomography imaging for subjects diagnosed with Frontotemporal Dementia.   "
18707|NCT03040700|"     The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three     different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A     total of 600 patients will be included and followed for 5 years. Patients will be randomly     allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will     be followed by regular medical visits only every 6 months; patients in the functional arm     will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected     to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms     every 2 years after the first year post-surgery. The primary outcome will be the incidence of     death, acute myocardial infarction or myocardial revascularization.   "
18708|NCT03040687|"     Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and     therapeutics are under development to prevent ETEC disease in children and travelers. One     approach is to use passive protection (antibodies) to prevent infection. The purpose of this     study are to assess the safety of serum-derived bovine immunoglobulins in healthy adult     subjects when orally administered and to estimate protective efficacy of those preparations     against moderate-severe diarrhea upon challenge with the ETEC strain B7A.   "
18847|NCT03038880|"     This is a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to     investigate the efficacy, safety and pharmacokinetics of RO6867461 (RG7716) administered with     extended dosing regimens in treatment-naive participants with nAMD. Only one eye will be     chosen as the study eye.   "
18709|NCT03040674|"     The purpose of the Lung Institute is to collect and isolate a patient's own cells and     platelet rich plasma (PRP) and deliver the product back to the patient same-day. Lung     Institute's treatment is limited to self- funded patients with chronic lung disease - chronic     obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells     and platelet rich plasma are collected through venous or bone marrow harvesting techniques.      The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse     events, a perceived improvement in the patient's lung condition (to be determined by their     ability to be more physically active; walking greater distances with or without oxygen and     improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability     to reduce their use of oxygen and possibly to stop it., the ability to function well without     the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction     in emergency room visits and exacerbations related to their disease.   "
18710|NCT03040661|"     Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including     a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the     procedure, heparin is administered to maintain a target ACT > 300 seconds. At the conclusion     of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at     least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach,     an ACT is checked and protamine is administered. The ACT is rechecked 20 later, and if < 220     msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual     Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in     each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need     for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).   "
18711|NCT03040648|"     Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat     spinal radicular pain. However, inadvertent intravascular injection can lead to severe     neurologic complications. Digital subtraction angiography (DSA) during epidural block might     increase the detection rate of intravascular penetration, compared to real-time fluoroscopy     (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and     participants and the high cost of the new and upgraded fluoroscopic equipment. In this study,     it was designed to compare DSA and RTF for detection of intravascular penetration in the same     participant who underwent cervical TFEB.      The investigators prospectively examined the participants who received cervical TFEB. The     needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media     was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic     contrast media was injected at the rate of 0.5 ml/sec under DSA.   "
18712|NCT03040635|"     This is a randomized, placebo-controlled study to investigate the safety, tolerability,     pharmacokinetics and pharmacodynamics of single oral doses of RO7034067 in healthy Japanese     participants.   "
18713|NCT03040622|"     This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure     using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other     bio-markers, will be measure before, during, and after WATCHMAN implantation at several     follow up visits.   "
18714|NCT03040609|"     The main objective of this study is to develop and validate a visio-behavioral scale of     visual abilities for subjects with profound multiple intellectual disabilities.      The secondary objectives of the study are:        -  to validate the structure of the scale.        -  to evaluate the reproducibility of scale with the intra- and inter-examiners, and the          influence of the different professions of examiners.        -  to evaluate the feasibility of visio-behavioral scale.        -  to evaluate the sensitivity to change.        -  to study the uniformity of use of the scale depending on the type of patients (age,          disability level, pathology).        -  to study the prevalence of the visual disorder in profound multiple intellectual          disabilities subjects.   "
18715|NCT03040596|"     Voice disorders are the most common communication disorder across the lifespan and vocal fold     nodules are the most frequent pathology affecting voice in children. The goal of the present     study is to determine the safety and feasibility of a short-course of inhaled corticosteroids     in addition to standard voice therapy for treating vocal fold nodules.   "
18716|NCT03040583|"     The ASSESS national multi-center prospective cohort (Assessment of Systemic complications     (Signs) and Evolution in Sjögren's Syndrome SS) was set up in 2006 thanks to a grant of the     French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included     consecutive patients with Primary Sjögren's Syndrome pSS fulfilling American-European     Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics     Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This     study was followed for 5 years with the grant of the French Ministry of Health and this study     will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for     a duration of 20 years, a thorough standardized paper case report form (CRF) was filled     prospectively by clinicians.   "
18717|NCT03040570|"     A feasibility study to determine if it is possible to perform a safe, adequately powered, and     affordable multi-centre study in critically ill children comparing current practice of     liberal targets for systemic oxygen levels with more conservative targets.   "
18725|NCT03040466|"     Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases     including urinary stones. However, they require a long turnover time between procedures     because of the sterilization process. Moreover, repeated use of a scope ultimately     deteriorates its image quality which leads to a high maintenance cost in the long-term. A     disposable digital flexible ureteroscope was released in the United States in January 2016,     offering an improved image resolution, new scope performance characteristics with every case,     and no need for sterilization and repair. Preliminary data from our center has demonstrated     that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope     and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment     with disposable scopes may be more effective for patients and facilitate cost management     within the hospital.      Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes     between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.   "
18718|NCT03040557|"     The plantar fasciitis (PF), most frequent injury of the musculoskeletal system, is the main     cause of heel pain and functional disability. The mechanical stress, stretching of plantar     fascia consequently the overload on the feet, is a major intrinsic causes the onset of FP,     especially when exposed to repetitive activities, such as walking. Another extrinsic     etiologic factor of great influence is inadequate shoes that can lead to a deterioration and     progression of the disease. One of the great difficulties of their conservative treatment is     long rehabilitation period, lasting on average 10 to 18 months. Among them, the insoles stand     out as one of the effective mechanical treatments to improve the immediate pain symptoms, in     the short term. Other literary evidence, not specific to FP, has shown the benefits, the     short and long term, a flexible footwear promotes more flexible feet and overload reduction.     Objective: Verify therapeutic effect in the long term, a flexible footwear and low cost and     orthopedic insole on the clinical aspect, functional and biomechanics of the gait of women     with acute FP and chronic with presence of heel spur. It will be conducted a randomized     controlled trial with blinded evaluator, in which 75 women with plantar fasciitis will be     randomized and allocated to the intervention group with flexible footwear (GIC, acute n=15     and chronic=15) or the intervention group with orthopedic insole (GIP, acute n=15 and chronic     n=15) or control group (CG, n=15). The intervention will have duration six months, six hours     a day, seven days a week (42 hours/week). For all groups will be allowed to use pain     medication support (paracetamol 500 mg) with a maximum dose of two grams daily. The primary     outcome will be the symptom of pain verified by visual analogue scale (VAS), and the     secondary: the inability to areas of the feet by the total score of the FFI (Foot Function     Index), health feet by FHSQ-Br questionnaire (Foot Health Questionnaire Status), the distance     traveled by the six-minute walk test (6MWT), paracetamol consumption and the joint angles of     the lower limbs, plantar pressure and ground reaction force during gait. The effects of time     (Start, 3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are     calculated by means of ANOVA case-wise two factors. A 5% alpha to significant differences and     Cohen coefficient for describing the size effect of the intervention is assumed.   "
18719|NCT03040544|"     Background: Laparoscopic surgical procedures have become increasingly established in     operative medicine. They require special motor, haptic, and spatial-visual skills to perform     the interventions safely and effectively. The basic skills are often learned in the operating     room on the patient. This is economically inefficient and can be improved with regard to     patient safety. Against the background of this problem, various simulators were developed in     order to train laparoscopic basic skills outside the surgery. The Lübecker Toolbox (LTB)     curriculum is a video-based trainer, which - unlike the other trainees on the market - has     standardized and validated exercises with concrete targets, based on the skills of experts in     minimally invasive surgery (MIC). Against the background of different, non-validated training     programs and simulators with ambiguous objectives, it is not known how training programs and     simulators improve the skills of the advanced physicians in performing laparoscopic-assisted     operations. An evidence of effectiveness in the practice transfer could have a considerable     relevance with regard to the integration of the training programs into the specialist     doctoral training.      Aim of the study: The aim of the study is to investigate whether physicians in the first     years of further education are able to improve laparoscopic skills required to perform     laparoscopic operations, if they have successfully completed the LTB curriculum.      In the prospective study, the subjects are randomized into two groups, one group completing     the LTB curriculum after the first own laparoscopic cholecystectomy and the other not. After     2 months, both groups will perform their first laparoscopic cholecystectomy again. The     laparoscopic video recordings will be analysed and compared using the Global Operational     Assessment of Laparoscopic Skill (GOALS) score.   "
18720|NCT03040531|"     Prolonged glucocorticoid therapy affects bone fragility, cardiovascular health, glucidic and     lipidic metabolism, thyroid and brain function. Glucocorticoid-induced osteoporosis is     characterized by low bone turnover and fractures, which occur in 30-50% of patients.     Glucocorticoids affect predominantly cancellous or trabecular bone, increasing the risk of     vertebral fractures, which may be asymptomatic and occur early during the first months of     glucocorticoid treatment. Genistein exerts biological effects by several potential     mechanisms. Besides protective effects on bone loss, genistein reduces cardiovascular risk     markers, improves endothelial function and ameliorates glucose and lipid metabolism. This     study is aimed at demonstrating genistein efficacy in glucocorticoid-induced osteoporosis in     a cohort of caucasian post-menopausal women.   "
18737|NCT03040310|"     The prevalence and disability associated with discogenic low back pain are significant, and     there is a general lack of widely accepted conservative treatments for the condition. A     majority of previous studies that have assessed the efficacy of self-directed exercise-based     rehabilitation programs did not include comprehensive metrics to confirm whether participants     actually participated in the exercises prescribed. In this pilot study, the investigators     hope to determine whether proxies of compliance with a daily, self-directed rehabilitation     program for discogenic low back pain are correlated with participant-reported improvements in     pain and function. The feasibility of a mobile interface designed to help patients with     chronic low back pain track the daily management of their conditions will also be evaluated.   "
18738|NCT03040297|"     The study investigates if there are benefits (better oxygenation, minimized work of breath)     from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide     respiratory support in tracheostomized patients and avoid mechanical ventilation.   "
18721|NCT03040518|"     In 2014, 24% of UK men were obese. However men rarely participate in weight loss programmes.     This study looks at whether two interventions which show promise can help obese men lose     weight and keep it off.      INTERVENTION 1: Sending text messages to a mobile phone. These will be written as though they     come from other men who are also losing weight and include 'how to do it' diet and physical     activity tips, combined with friendly humour and support.      INTERVENTION 2: The same texts plus promising men money at the start contingent on weight     loss achievement. The money will vary over a year according to whether weight targets are     met. This is called an endowment incentive and is based on research showing that modest     payment helps people change their diet and physical activity. At the 3, 6 and 12 month     weighing appointments, men will have the option of continuing with the original weight loss     targets of 5%, 10% and 10% or setting lower targets of 5% of body weight at 6 months and 5%     at 12 months. This is to maintain motivation and hope for men who do not meet the more     ambitious weight loss targets.      This study examines if the texts work better with incentives than alone. Both interventions     are delivered from a computer and have potential to reach large numbers, including men who     don't use health services. This work is done together with obese men and a charity for men to     help us find the best ways to deliver the interventions to as many men as possible, including     men in difficult life situations.      This study will examine whether it is acceptable and feasible to randomise obese men to three     groups: texts only; texts and incentive; or to a 'control group' who wait a year and then get     the texts for 3 months. The feasibility of recruiting 105 obese men from two regions of     Scotland will be assessed. Half of the men will get an invitation letter from their GP. The     other half will be approached in the community, given information about the study and invited     to take part. Men can take part if their waist circumference is 40 inches and more or their     Body Mass Index is 30 or higher. The study examines how long it takes to find 105 obese men     who want to take part, how many come back to suitable venues at 3, 6 and 12 months to get     weighed and answer questions about their quality of life, lifestyle and motivation. At the     end participants will report about their experiences of weight loss and of being in the     study.   "
18722|NCT03040505|"     The aim of the study is to investigate temporal organization of future thinking in patients     with schizophrenia. Patients and control participants will be asked to envision and briefly     describe ten personal future events using a cue-words list. Then they will be asked to     describe everything that came to their minds (i.e. to think aloud) while they attempted to     determine when an event will likely occur. The investigators will compare the proportion of     several predefined strategies mentioned by the two groups of participants to locate future     events in time. The investigators predict that patients will envision less personal future     events and will rely to a lesser extent on strategies to locate events in time, than control     participants.   "
18723|NCT03040492|"     The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene     polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC)     and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant     demographic information such as physical characteristics (e.g., ethnicity), family history,     and cancer diagnosis will be collected in order to determine if there are relationships     between the gene polymorphisms, cancer diagnosis, and these characteristics.   "
18724|NCT03040479|"     This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This     study will enroll up to 24 subjects and will include 2 hepatic impaired subject groups and     one group of control subjects with normal hepatic function.   "
18889|NCT03038321|"     Compare the different supposed clinical treatment of side effects associated with     intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs     lornoxicam (NSAID)   "
18890|NCT03038308|"     The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist     ropinirole for the treatment of hyperprolactinemia in patients with idiopathic     hyperprolactinemia and prolactinomas.   "
18726|NCT03040453|"     Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not     eligible for liver transplant or liver resection. At our Hospital two different methods are     used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible     electroporation, where the tumor cells are exposed to an electrical field and nano-pores are     formed in the cell membranes and the cells go into apoptosis (programed cell death).      Previous studies have shown effects on the immune system after ablative therapies.      The purpose of this study is to compare the immunological response after the wo different     methods of killing the tumor cells.   "
18727|NCT03040440|"     The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard     endotracheal tube during laparoscopic cholecystectomy.   "
18728|NCT03040427|"     The investigators postulate that F-18 florbetapir will show improved detection of cardiac     amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.   "
18729|NCT03040414|"     Adolescents and young adults with type 1 diabetes often have a difficult time achieving good     glucose control which is so important in reducing the risk for diabetes complications.     Despite the use of multiple daily injections or insulin pumps and glucose sensors there is     still a need for many individuals to further improve glucose levels but do so without causing     low blood glucose levels (hypoglycemia) or adding to the daily burden of living with     diabetes. Today an insulin pump can receive glucose readings from a continuous glucose     monitor and adjust the insulin delivery up or down in an attempt to keep glucose levels in a     more optimal range. These systems are called hybrid closed loop meaning while much of the     insulin delivery is automated the patient still interacts regularly with the system     particularly to help determine the insulin dose to deliver to cover a meal. Results of early     studies using hybrid closed loop systems in adolescents and adults with type 1 diabetes are     very encouraging. This study will compare the FDA-approved hybrid closed loop system by     Medtronic (670G) to a next-generation Medtronic system programmed to further improve glucose     control, particularly around mealtime, which is currently one of the biggest challenges with     all hybrid closed loop systems. One hundred adolescents and young adults (ages 14-30) will     test each system for three months in a crossover fashion. The investigators will compare how     effective each hybrid closed loop system is at preventing high blood glucose readings during     day. The investigators will also evaluate the safety of each system and how participants     adjust to the daily use of the technology.   "
18753|NCT03040102|"     The purpose of this research study is to compare two ways to educate patients with cancer and     their caregivers about hospice care services   "
18754|NCT03040089|"     This is a prospective, multi-center, split-face, controlled clinical trial that aims to     investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet     laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial     will be performed by two Korean institutions on 45 subjects.   "
18923|NCT03036852|"     The primary objectives of this study are to evaluate safety, efficacy and tolerability of     treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults     with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal     Disease (ESRD).   "
18730|NCT03040401|"     Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2     (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6     week rest periods.      All subjects will be assigned to one of three consecutive cohorts, each comprising five     patients.      Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the     assessment of short-term impact of HDC alone on clonal and immunological markers. For all     remaining cycles the combination of HDC and IL-2 will be given.      Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all     patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical     response and toxicity will be evaluated. On the basis of the results for the first 4 cycles     of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the     combination of HDC/IL-2 or HDC alone.      In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10     cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.      IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during     treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a     family member/significant other will be instructed to administer injections of both study     drugs to allow safe treatment at home.   "
18731|NCT03040388|"     The main purpose of this study is to determine whether electroconvulsive therapy (ECT) causes     any structural or functional brain changes and thus indicating its mechanism of action. The     second aim is to find predictors of an immediate response, sustained remission, relapse and     side-effects. Thirdly, this study aims to explore whether ECT causes any changes in     blood-brain barriers permeability and whether these changes correlate to memory problems. The     fourth objective is to examine whether ECT causes any brain tissue damage.   "
18732|NCT03040375|"     Undernutrition and poor cognitive development affect many children under 5 in developing     countries, who are exposed to multiple risk factors including poverty, malnutrition, poor     health, and unstimulating home environments. The optimum development and growth of young     children requires affection and responsiveness from the mother/caregiver, cognitive     stimulation, good nutrition and infection control. In Bangladesh, stimulation at home is     generally poor and contributes to children's poorer development. It is important to show that     psychosocial stimulation programmes through home visits integrated into the feeding     programmes can benefit children's growth and development. This study will help to fill this     evidence gap about effective interventions to improve infant and young child growth and     development in Bangladesh. Considering the high prevalence of undernutrition and low     prevalence of stimulating environments in Bangladesh, it is important to show evidence that     integrating infant feeding counselling and psychosocial stimulation activities result in     optimum child growth & development. To determine if combined infant feeding counselling and     psychosocial stimulation programme (promoting mothers positive parenting) starting in the 3rd     trimester of pregnancy, further improves: children's cognitive, motor and language     development along with growth and mothers' child rearing and child-feeding knowledge and     practices compared to peer counselling alone or usual health messages only. We used a     community-based CRCT to examine the impact of a peer counselling infant feeding education     program with psychosocial stimulation starting in the third trimester of pregnancy to one     year after delivery, to improve child growth and cognition, language, behaviour and     psychomotor development compared to a control group receiving usual health messages. The     outcome assessments were made on a cohort of infant-mother dyads measured at baseline and at     follow up visits. Outcome assessments were conducted with all the mother-infant pairs     recruited in the community clusters in the study, with an expected total of 334 mother-infant     dyads (167 in each treatment group).The main outcomes are children's growth, cognition,     language, behaviour and psychomotor development   "
18733|NCT03040362|"     This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study     of [14C]-lasmiditan administered as a 200-mg (approximately 100 µCi) oral solution to 8     healthy male and female subjects, following at least a 10 hour fast from food to assess the     pharmacokinetics (PK), metabolism, and routes and extent of elimination of a single oral dose     of 200 mg (approximately 100 µCi) [14C] lasmiditan in healthy male and female subjects.   "
18743|NCT03040232|"     The purpose of this study is to identify predictors of future injury and disability following     LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with     LPD following surgical and non-surgical management. Currently, there is limited information     available to clinicians regarding appropriate criteria for returning athletes to sports     participation following LPD. The evidence produced by this study will provide necessary     information to develop appropriate rehabilitation strategies that may reduce the risk for     future patellar instability and associated patellofemoral joint dysfunction and pain.   "
18744|NCT03040219|"     Folic acid as a appetizer in primary malnutrition   "
18734|NCT03040349|"     The overall aim of the TiTAN Greece & Cyprus project is to expand the Global Bridges Tobacco     Treatment Training Network in the WHO Europe region through a focus on primary health care     providers in Greece and Cyprus. A robust evaluation will be conducted alongside the TiTAN     program. A pre-post evaluation will be used to examine the impact on the TiTAN program on:        1. Provider engagement (number of providers attending training), number of local champions;        2. Provider knowledge, beliefs, perceived behavioral control, and intentions related to the          delivery of tobacco treatment;        3. Rates of evidence-based tobacco treatments (5As) are delivered to patients who smoke;        4. Provider satisfaction with training program, resources, and network outreach activity          and areas for improvement; and        5. Estimates on the impact on patient-level outcomes including number of patient quit          smoking at 1 and 3-month follow-up.      All PHC providers will be surveyed before and after the intervention program is delivered. We     will randomly select a sub-sample of providers and will survey patients from their practice     before and after the intervention program in order to validate changes in 5As delivery.     Qualitative interviews will be completed with a sub-sample of providers at the end of year 1.   "
18735|NCT03040336|"     Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran     population grows older and more frail, there is a critical need to identify effective     strategies for reducing surgical risks for these patients. Prior research shows that     inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and     improve outcomes by building strength and improving nutrition. We believe that similar     improvements may be obtained by using similar interventions before surgery to prehabilitate     patients' capacity to tolerate the stress of surgery. The proposed research will examine the     feasibility of a new, prehabilitation intervention aimed at improving postoperative surgical     outcomes through preoperative exercise training and nutritional supplementation. Findings     from the study will inform the design of a larger randomized controlled trial of the     prehabilitation intervention. If proven effective, prehabilitation could benefit as many as     42,000 frail Veterans who are scheduled for major elective surgery each year.   "
18736|NCT03040323|"     The investigators plan to compare complication and success rates between two methods of     ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol     without contrast.   "
18739|NCT03040284|"     In patients at risk of increased intracranial pressure (ICP), ICP measurements require     invasive transducers, usually with insertion of a catheter into the cranium, or through a     spinal tap. These invasive modalities involve risks and pain and they can be done only in     specialized care units, with a high associated cost.      A novel method for detecting changes in ICP has developed recently. The auditory hair cells     emit sounds and electric signals in response to sound, which can be easily detected and     measured non-invasively with the help of a microphone probe placed in the external ear canal     or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)     spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within     seconds.      The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically     used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical     signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with     a standard imaging method (TDM).      The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another     disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes     patient clinical worsening and / or imaging.   "
18740|NCT03040271|"     Evaluate the feasibility and effectiveness of a multi-component school-based intervention to     promote healthy eating and physical activity with school children ages 9 to 11 years in     Lebanon.   "
18741|NCT03040258|"     Evaluate the feasibility and effectiveness of a multi-component school-based intervention to     promote healthy eating and physical activity with school children ages 9 to 11 years in     Lebanon.   "
18742|NCT03040245|"     Whiplash trauma and the resulting whiplash associated disorders have been the subject of much     attention in the scientific literature and remain a major public health problem.      The most commonly encountered symptoms are neck pain, headache, low back pain, shoulder pain,     as well as visual impairment. It is not unusual for neck pain to become chronic, and when     this occurs, there may be serious consequences on a social, professional and financial level.      Even though the role of the initial episode should not be ignored, progression to chronic     pain is probably multifactorial and, like non-specific low back pain, psycho-social factors,     and in particular patient fears and belief, seem to play a relevant role, as do environmental     factors. The professional consensus is that it is useful to provide targeted information at     an early stage in whiplash settings in order to reduce mistaken fears and beliefs. A     preliminary study enabled the investigators to validate a French version of an information     booklet that draws on validated data from evidence-based medicine. The booklet was Le guide     du coup de fouet cervical, the French version of The Whiplash Book. This study showed that     fears and beliefs were considerably high in a population without neck problems who were     working in hospitals. It also revealed that simply providing information could help lessen     them.      Management following whiplash injury can make use of the recommendations as published in the     literature. Healthcare professionals must reassure and educate their patients that     post-traumatic pain is normal, and that they need to remain active and maintain physical     activity in order to improve their prognosis.      Only very few studies have evaluated the adherence of physicians or healthcare professionals     to the guidelines and to ways of changing their approach to treatment.      The main aim of this study was to determine what fears and beliefs physicians have about the     consequences of whiplash. The secondary aim was to measure the impact of a validated     information booklet on emergency physicians' approach to management following a whiplash     injury.   "
18891|NCT03038295|"     The purpose of this study is to evaluate the safety and efficacy of oral/local propranolol in     preterm newborns who diagnosed as early phase of retinopathy of prematurity (ROP).   "
18746|NCT03040193|"     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various     bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often     reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be     significantly improved with control of cough. Use of sedation during bronchoscopy has been     reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is     routinely performed at many centres including ours.      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is     limited literature on the efficacy of lignocaine delivered with the nebulized route during     awake flexible bronchoscopy. This study would help to determine the utility of nebulized     lignocaine in airway anaesthesia during flexible bronchoscopy.   "
18747|NCT03040180|"     The purpose of this study is to evaluate the efficacy and safety of neoadjuvant     electrochemotherapy on locally advanced rectal cancer (UICC II-III) in an intended curative     clinical setting, using an endoscopic electroporation device (EndoVE).   "
18748|NCT03040167|"     The pectoral block is a recently developed regional anesthetic technique that can be used for     the treatment of postoperative pain after breast surgery. Injection of local anesthetic     between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block.     This block has not been well characterized in terms of its blocking effects on motor and     sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical     trial is divided into two sections: a volunteer study and a patient study.      For the volunteer study, the aim is to assess the sensory territory affected by injection of     local anesthetics through a PEC 1 block and to assess motor function in terms of strength of     adduction of the affected limb using a dynamometer.      In a prospective, randomized, controlled and double blind study, the aim is to assess the     postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral     breast augmentation surgery.   "
18749|NCT03040154|"     The objective of this community-based randomized controlled trial is to evaluate the outcomes     of a theory-based parent engagement intervention (i.e., culturally-tailored video) aimed at     promoting the participation of Filipino parents and grandparents in an evidence-based     preventive parenting intervention.   "
18750|NCT03040141|"     This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs     oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen     support.   "
18751|NCT03040128|"     To date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral     hemorrhage (ICH). This study will use intravenous (IV) minocycline in ICH to evaluate for (1)     safety/ tolerability and (2) evaluate for clinical efficacy   "
18752|NCT03040115|"     The aim of this study is to conduct survey-based assessments for the safety of air travel in     patients with Birt-Hogg-Dube syndrome (BHD). The study will enroll patients through the     clinic network at Rare Lung Disease Consortium (RLDC) and through the BHD foundation website.     Patients will have access to the questionnaire via REDCap (an online data management system)     and each patient will be provided with a link to complete the survey. The investigators plan     on enrolling approximately 100 patients with BHD for the purpose of this study. Secondary     aims of this study include further characterization of the clinical aspects of disease and to     establish a contact registry for these patients, in order to facilitate future studies.   "
18755|NCT03040076|"     The purpose of this study to test a computerized treatment designed to help people with high     levels of emotional eating, which is when people eat to cope with negative emotions and/or     stressful situations. The investigators are interested in comparing two different ways of     coping with negative emotions, relaxation training or training in how to think differently     about such situations. Additionally, the researchers' study seeks to understand more about     the psychological factors that may contribute to someone having difficulty with emotional     eating.   "
18756|NCT03040063|"     Use of endovascular techniques - implantation of a peripheral stent graft and a peripheral     flexible stent to isolate the sac of the popliteal artery aneurysm from the circulation and     subsequent topical application of a thrombolytic (rtPA) to restore patency of the lower leg     blood stream - will lead to a comparable or better outcome in treatment of patients with the     popliteal artery aneurysm and acute critical limb ischaemia, compared to currently prevailing     use of surgical treatment.   "
18757|NCT03040050|"     The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive     either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or     standard of care (control) prostate biopsy. The subjects will have a rectal culture swab     performed prior to the prostate biopsy. One rectal culture swab will be used for rapid     multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The     subjects randomized to the intervention group will have the qPCR results shared with the     physician to determine if additional standard of care antibiotics are needed at time of     standard of care prostate biopsy. The subjects randomized to the control group will not have     the qPCR results shared with the physician to determine if additional standard of care     antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days     after the prostate biopsy, the research staff will conduct a chart review and/or telephone     call to ask about any prostate biopsy infections and complications.   "
18758|NCT03040037|"     This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation.     This study is observational, prospective, multicenter, open-label   "
18759|NCT03040024|"     The goal of this prospective randomized double blinded placebo controlled study is to     investigate if a single dose of ketamine in addition to standard anesthesia will reduce the     risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on     post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will     be utilized during the surgical procedure to evaluate its potential as a possible predictive     device for delirium.   "
18760|NCT03040011|"     To test the hypothesis that preoperative injections along the levator ani muscles and     pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical     reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total     of 75 women will be performed.      The study population will be adult women (>18 years of age) with uterovaginal or vaginal     vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which     includes an apical support procedure. Participants will be enrolled prior to surgery. The     procedure will involved four injection sites: the bilateral levator ani muscles via a     transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random     assignment will occur to one of three study arms: combined arm (20 milliliters     bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm     (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20     milliliters saline divided between the 4 injection sites).   "
18761|NCT03039998|"     The main objective of project is to compare validity of sampling methods performed routinely     (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological     agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to     bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using     bronchial secretion sampling in HAP diagnostics and detection of the most common etiological     agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude     the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens     transmission molecular biology analysis of etiological agents is performed. Finally,     percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be     observed.   "
18762|NCT03039985|"     The aim of the study is to evaluate the complication rate of 2 types of all-ceramic crowns in     patients with or without bruxism.   "
18763|NCT03039972|"     Cross-sectional evaluation of hydration status and kidney function in patients with pulmonary     hypertension   "
18764|NCT03039959|"     Evaluation of renal function in patients with pulmonary hypertension undergoing right heart     catheterization   "
18765|NCT03039946|"     The aim of this study is to compare hemodynamic variables and outcome in patients undergoing     laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an     automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow     monitoring or a restrictive fluid therapy of 4ml/kg/h.   "
18767|NCT03039920|"     Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine     its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO)     concentration, both acutely and after 1 month of use.   "
18768|NCT03039907|"     The main purpose of this study is to examine the factors that allow patients that undergo     total knee arthroplasty to return to recreational sports and/or work activities, and to     achieve recommended physical activity levels.   "
18778|NCT03039777|"     Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI).     Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its     role as a surrogacy marker in CRBSI.   "
18780|NCT03039751|"     The purpose of the study is to evaluate the safety and efficacy of catheter mediated     endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative     gene transfer in patients with refractory angina to whom revascularisation cannot be     performed.   "
18781|NCT03039738|"     The purpose of the study is to evaluate the impact of surveillance monitoring versus     telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative     outcomes.   "
18782|NCT03039725|"     Retrospective study to assess a single Clinic on Immunization Practices (ACIP)     recommendations for hepatitis A, hepatitis B, influenza, tetanus/diphtheria/pertussis, HPV     and pneumococcal disease   "
18769|NCT03039894|"     School engagement is associated with children's long-term health and success. Students who     are engaged in school have better academic outcomes and lower rates of risky health     behaviors. The investigators partnered with Alliance College-Ready Middle Academy 12     (Alliance 12), a charter school in Los Angeles, to develop the gradebook game, an     intervention that aims to improve academic achievement, peer support, and school engagement.     The game involves frequent feedback on students' school performance, team-based competition     aligned with the school mission, and peer mentorship by team captains. For the 2016-2017     academic year, the investigators will assist Alliance 12 in implementing the gradebook game     in two of its five 6th grade homerooms. The investigators plan to evaluate whether the game,     as hypothesized, is effective in increasing school engagement, including academic performance     and positive behavior.      In order to conduct this evaluation, the investigators plan to enroll 6th grade students by     obtaining parental consent and student assent at the beginning of the school year. Students     will be enrolled for the entire 2016-2017 academic year. All study procedures except for     parental recruitment will occur during the school day. Participation in the study involves     completing 2 student surveys and permitting the collection and analysis of student data from     the online gradebook and behavior system. The investigators plan to use an interrupted time     series design that will analyze student gradebook and behavior data at multiple time points     before and after the game starts. The surveys will be completed at the beginning and end of     the study period. Surveys will include measures of self-reported school engagement, age,     gender, race/ethnicity, primary language at home, social and emotional well-being, social     status, and peer support. Surveys will be administered via iPad.      If the pilot study demonstrates that the gradebook game is effective in promoting school     engagement and academic achievement, it is anticipated that it could be widely adopted and     more rigorously evaluated in a larger study. Because the gradebook game is a low-resource     intervention, it could easily and sustainably be replicated, providing a much-needed tool for     schools with low engagement.   "
18770|NCT03039881|"     This observational study investigates the validity and utility of a new, non-significant     risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients     undergoing elective surgery under general anesthesia. The study patients will be monitored     before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for     the first post-operative night. The physiologic data will not be used or influence the     standard of care for subjects. It is anticipated that this monitor may be able to improve     perioperative care in the future.   "
18771|NCT03039868|"     SLC6A14 may serve as a biomarker for cervical dysplasia or cervical cancer.   "
18772|NCT03039855|"     To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve     with the Tiara Transapical Delivery System.   "
18788|NCT03039647|"     Premature and accelerated brain aging trajectories have been observed among people with     metabolic dysfunction, but mechanisms of these altered trajectories are not understood.     Insulin resistance (IR) is known to change with age and affect cognition in older and elderly     adults as well as in patients with mood disorders. The main purpose of the study is to     describe the developmental trajectory of cognitive and neural biomarkers across the spectrum     of metabolic dysfunction in overweight/obese adults younger than 50 years of age. The     innovative study design will allow the investigators to examine cognitive outcome development     over a 25-year span without an investment into the longitudinal observation of changes in     cognition and neural function.   "
18789|NCT03039634|"     This study evaluates the safety, effectiveness, and maintenance of effect of a novel topical     silver particle solution (Sienna 755.1100, 810.1100, or 1064.1100) used in conjunction with a     laser for the treatment of Acne Vulgaris.   "
18773|NCT03039842|"     This is a research clinical trial of double-blind, stratified randomized, parallel group,     two-centre study. It will be conducted in a total of 250~300 male and female subjects from     the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects     will be psychiatric out- and in-patients, aged between 18~65 years old, who have psychiatric     evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion     and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place     will commence at randomization for while patients continue open-label valproate. Subjects     will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg     dextromethorphan+valproate, (2) 5mg memantine+valproate, (3)     dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine     medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or     insomnia during the study. For the consideration of the less influence to immune-system,     resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the     treatment response and side effect to clarify the curative effect of DM and memantine add-on     therapy to valproate in the treatment of bipolar disorders. This study is being performed to     investigate the possibly significant beneficial effects on the subtypes of bipolar disorders     psychopathology.   "
18774|NCT03039829|"     This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses     will differentially affect hemodynamic variables compared to a placebo.   "
18775|NCT03039816|"     Background: A nasally applied cellulose powder is increasingly used in many countries as a     remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children     showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen     counts. The present study in grass pollen-allergic adults used the same basic design.     Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients     with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were     used as reminders of treatment and reporting of symptom scores.   "
18776|NCT03039803|"     In recent decades, the rate of cesarean section delivery has steadily increased worldwide     ranging at 30% of deliveries, thus long-term risks after cesarean section need to be     evaluated. Postoperative risks include, among others, uterine scar rupture and placental     complications such as placenta previa and accreta- complications, which are possibly     associated with uterine scar dehiscence.      The prevalence of lower-segment uterine scar deficiency has previously been described as 63%.     One recent systematic review and meta analysis investigated closure techniques of low     transverse cesarean. No significant difference in risk of uterine scar defect comparing     single layer versus double layer closure could be detected (RR 0.53), whereas in women with     single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However,     the authors do conclude that data is insufficient to determine the risk of uterine rupture,     dehiscence or gynecological outcomes due to insufficient power of available studies. A     recently published Randomized Controlled Trial concluded that double-layer closure with     unlocked first layer showed a better scar healing than locked single layer.      The investigators main objective is to identify if single-layer suture of the uterus during     cesarean section results in a higher rate of cesarean scar deficiency than double-layer     suture.      Interventions      Single- layer versus double- layer uterine closure Two different techniques of uterine     closure in cesarean section will be compared: single- layer versus double- layer continuous     uterotomy suture.      Standardized transvaginal sonography      Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound     machine used for all examinations is GE Voluson E10.      Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after     CS (yes/no).      Secondary outcome: Myometrial thickness at the site of uterine scar (mm).   "
18777|NCT03039790|"     The purpose of this study is to evaluate descriptively the long-term immunogenicity of at     least 1 Norovirus GI.1/GII.4 bivalent VLP vaccine (NoV) vaccine administration.   "
18786|NCT03039673|"     MIROCALS is a phase II study of ld-IL-2 as a therapeutic agent for ALS. A randomized (1:1),     placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2     safety and clinical efficacy on survival and functional decline in newly diagnosed ALS     patients treated for 18 months. Randomization will be stratified according to (i) country (n     = 2 levels: UK, France) and (ii) site of onset (n= 2 levels: bulbar vs limb onset).      The primary objective to evaluate the clinical efficacy and safety of the experimental drug     (ld IL-2) over an 18 months period in order to establish the proof of concept (PoC) that     modifying immune responses through the enhancement of regulatory T cells modifies the rate of     ALS disease progression.   "
18787|NCT03039660|"     This study aims to investigate the feasibility and efficacy of online student wellness     courses for improving medical student mental health and well-being.   "
18791|NCT03039608|"     The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial     esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently     these years especially in Asian countries. However, besides of perforation and bleeding,     another complication postoperative esophageal stricture is frequently observed after the     removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative     stricture substantially decreases the patient's quality of life, requiring further therapy.     Although the exact incidence is unknown, esophageal stricture is supposed to be related to     the extent of the circumference being resected. In previous study by Ono et al，it is reported     that 90% of patients with lesions of circumferential extension of more than three-fourths     experienced postoperative stricture after esophageal ESD. There were some reported studies     exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and     local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but     also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled     that just oral prednisolone oral is effective option for the prevention of post-ESD     stricture. However, most of the reported studies were non RCTs with small sample. In the     primary study, the investigators search a new method of combination of both oral and local     injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was     found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the     corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators     plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic     effects of combination of local steroid injection with oral steroid administration for     esophageal stenoses complicating extensive ESD.   "
18792|NCT03039595|"     Early rectal cancer can be removed by minimally-invasive surgery, and the standard     pathological assessment of the removed tumour gives valuable information about how advanced     the tumour is. This gives an indication of how likely the cancer is to recur, so doctors and     patient can decide on the most appropriate further treatment and follow-up. However there is     still much uncertainty in these predictions about recurrence. This study will assess two     further pathology tests, ploidy and stroma ratio in the tumour, by correlating the results     with outcome. This will determine whether these two tests provide additional value in     predicting outcome. If so, clinicians would be better able to advise patients with early     rectal cancer about their prognosis and further management.   "
18793|NCT03039582|"     Anovaginal distance measured by palpation and perineal ultrasound are similar.   "
18794|NCT03039569|"     In this proposed project the investigators will (1) examine the impact of diabetes     self-management education using text messaging on increasing awareness of CVD risk     perception, dietary intake, physical activity, diabetes self-management, and quality of life     among adults with type 2 diabetes; and (2) determine whether diabetes self-management     education using text messages improve HA1C among adults with Type 2 diabetes. The study     sample will include 100 adult type 2 diabetes patients (30 years or older). The recruited     adult type 2 diabetes patients will be randomly assigned into the intervention group (50     participants) and control group (50 participants). The intervention group will receive 3     messages weekly consisting of nutrition education and diabetes self-management information     and skills for 3 months (12 weeks). The messages will consist of information on how to     increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the     availability of fruits and vegetables and reduce high-fat and sugary foods in the home,     strategies to increase diabetes self-management skills, and awareness of cardiovascular     disease risk perception and knowledge. The text messages will be derived from the American     Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy     Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise) Text     messages will be positive and motivating and will include a link to a specific AADE7 handout     that allows participants to open and retrieve the specific AADE7 handout. The control group     will not receive text messages. The participants (both intervention and control group) will     complete surveys at baseline (before study begins) and at the conclusion of the study (at     three month of the intervention) about their dietary and lifestyle habits, diabetes self-care     management, awareness of cardiovascular diseases, home food environment and quality of life.     We will also collect patient's self-report Hemoglobin A1C values at baseline and at the     conclusion of the study (at three month of the intervention). If test effective, the proposed     text messaging intervention will help type 2 diabetes patients to manage diabetes and have a     healthier lifestyle.   "
18795|NCT03039556|"     This study investigates the effects of two weeks of reduced daily ambulation and a subsequent     return to normal physical activity on metabolic health of older adults.   "
18796|NCT03039543|"     Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the     mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia     for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the     use of sugammadex as a reversal agent may be associated with better endoscopic surgical     condition and recovery profile compared with moderate NMB during TURB.      This study was designed to compare patients with deep neuromuscular blockade (NMB) with     moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical     condition and postoperative recovery.   "
18797|NCT03039530|"     Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have     profound effects on mothers, their children, and their families. The cost of one case of PPD     exceeds $150,000, a significant proportion of which is related to its impact on offspring.     However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer     than 15% of women receiving care. While Public Health Units have played an important role in     PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver     evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group     format is effective for treating depression in the perinatal period, and as PHNs are often     the first point of contact for women experiencing PPD, with specialized training it is likely     that they can deliver high-quality CBT.      The primary objective of this study is to determine if PHNs can be trained to deliver group     Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence,     improve mother-infant attachment and parenting and optimize infant emotional functioning.   "
18798|NCT03039517|"     This is a two arm, prospective, single center, randomized clinical trial. Subjects will be     randomly assigned into one of two groups using block randomization technique in a 1:1 ratio.     The control group will receive care using elastic compression stocking and the intervention     group will use the ACTitouch device. Stratified randomization will occur based on whether the     Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed for     2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.   "
18799|NCT03039504|"     This is a randomized, double blind, placebo-controlled, comparative, prospective study     (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men     with mild to moderate erectile dysfunction.   "
18831|NCT03039088|"     This is a prospective observational national (France) study with 2 visits 3 months apart     (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is     500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF     alpha blocker.      The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on     the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and     pre-exposed patients.   "
18832|NCT03039075|"     Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is     approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are     equal to Glucophage is unclear.   "
18833|NCT03039062|"     This is an open , multicenter, interventional clinical trial to conform the role of of     miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.   "
18800|NCT03039491|"     The investigators hypothesized that pneumococcal vaccination with either the 23-valent     pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent pneumococcal     conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar antibody     levels/functional antibody activity and induce similar pneumococcal polysaccharide     (PPS)-specific B cell response in HIV positive individuals > 50 years of age, HIV positive     individuals 21-40 years of age as compared to HIV negative > 50 years of age. The     investigators immunized the study groups HIV+ persons >50, HIV+ persons 21-40 and controls     (HIV negative) with PCV 13 followed by PPV23 and HIV>50 with PPV alone and examined immune     responses to polysaccharide (PPS) 23 (F),14, 3, 7 (F) and 19 (A) using polysaccharide     specific ELISA and opsonophagocytic assays (OPA). Pre- and post-immunization peripheral blood     samples were obtained. Extensive B cell phenotype analysis using fluorescent antibodies was     used to characterize PPS-labeled B cells. Specific phenotypes were correlated with antibody     levels and OPA and compared to populations immunized with PPV   "
18802|NCT03039465|"     This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a     novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy     patients. 30 patients will be enrolled as an inpatient or outpatient.      Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and     trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have     undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP     insertion would be recruited to the study. Insertion of the TEP will be done in primary     setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be     evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the     procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same     day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months.     All the patients will be evaluated clinically for a fluid leak (through and around the TEP)     on the same days of voice analysis by giving test feeds under supervision.   "
18803|NCT03039452|"     Purpose: The purpose of this study will be to examine the feasibility and acceptability of a     6-week high intensity interval training (HIIT) program in patients with knee OA symptoms     ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body     metabolism induced by 6-weeks of HIIT.      Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA      Procedures (methods): All participants will be assigned to the single-arm of the study in     which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will     be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability,     feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes     will include whole body metabolism markers, inflammation, and a set of physical function     including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness,     isometric knee extensor and flexor strength (factors associated with physical function and     symptomatic knee OA progression), and body composition.   "
18804|NCT03039439|"     This is a pilot biomarker study designed to compare frequencies of mutations between groups     of malignant, benign and normal tissue or blood of patients with parathyroid disease and     identify the potential genes showing molecular aberrations as other types of cancer.   "
18805|NCT03039426|"     This randomized controlled trial, compared postoperative pain score in patient undergoing     cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac     intramuscular injection   "
18806|NCT03039413|"     This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography     (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing     surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells.     PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial     cancer.   "
18807|NCT03039400|"     Physical activity is a crucial component to wellness and is associated with multiple health     benefits. Persons with MS may find it challenging to participate in regular physical activity     or exercise, which is activity done to improve health and/or fitness. This research will test     an innovative web-based intervention to help persons with moderate-to-severe disability     manage their condition through a maintenance exercise program with specialized     physiotherapist guidance and support. The researchers will examine adherence to the web-based     physiotherapy program compared to standard physiotherapy care. Forty-five people with MS will     be randomly assigned to the web group or standard care group at a rate of 2:1. Participants     in the web group will receive supported and individualized web-based physiotherapy.     Participants in the standard care group will receive a written exercise program. Regular     participation (adherence) in the exercise programs will be evaluated in both groups over six     months. The research will also examine participant satisfaction with the programs, safety, MS     symptoms, and physical function. A web-based approach may be widely accessible to persons     with MS in their own homes and could support long-term participation in physical activity     important to wellness.   "
18834|NCT03039049|"     Purpose:The aim of this project is to prospectively determine whether a single dose of     GnRH-agonist administered at the time of implantation increases or not the reproductive     outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm     injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic     gonadotropin (hCG 1500 IU) the day of oocyte retrieval.   "
18808|NCT03039387|"     Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies     (ERS) are both central characteristics of major depression. Both are associated with reduced     activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current     stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the     cortical excitability. The goal of this randomized, sham-controlled, double blind clinical     trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC     and ERS in depressed patients compared to healthy subjects. Overall, the study will include     44 participants (22 depressed Patients and 22 healthy subjects). Each participant will     complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other     session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting     phase by means of a questionnaire and psychophysiological measures (heart rate variability).     The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use     of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this     experiment will provide new and reliable data for the development of new treatment methods.   "
18809|NCT03039374|"     There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in     Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter     lesion after birth can be challenging the total amount of women having obtained a sphincter     lesion could be even grater.      The aim of our study is to compare different tools in the diagnosis of obstetric anal     sphincter injury. In doing so the investigators hope to achieve early diagnosis of this     pathology and thus facilitate early treatment of a possible sphincter defect.   "
18810|NCT03039361|"     The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD     symptoms in veterans with PTSD as compared with existing care.      The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms     following participation in a 6-week Equine Assisted Psychotherapy program.   "
18811|NCT03039348|"     The purpose of this study is to investigate the factors influencing the decision about breast     reconstruction after breast amputation for breast cancer.      The study will be conducted at the University Hospital in Brussels using only a     questionnaire. The results might help us to evaluate and improve the satisfaction among     patients about the received information and guidance.   "
18812|NCT03039335|"     The objective of this study is to prospectively assess whether there is any interval between     first symptom and initial diagnosis that is experienced by patients with newly diagnosed     alpha-1 antitrypsin deficiency (AATD) and then to assess whether this diagnostic interval is     associated with worsened clinical status at the time of initial diagnosis.   "
18813|NCT03039322|"     This case-control study was conducted on 90 patients who were equally divided into two     groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical     or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed     to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using     ELISA technique   "
18814|NCT03039309|"     Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of     early gastrointestinal neoplasia.   "
18815|NCT03039296|"     In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive     therapy should be examined in (approximately 150) adult patients with low back pain positive     for facet joint pain component.   "
18816|NCT03039283|"     The aim of this retrospective study is to collect and assess hearing performance data that     have been measured by five clinics in Germany as part of their clinical routine in recipients     implanted with a commercial CI532.   "
18817|NCT03039270|"     This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted     aiming to assess the absolute risk of sensitivity with and without sonic activation of a     desensitizing gel previously to the in-office bleaching in adults.   "
18818|NCT03039257|"     The primary objective of this study is to establish that single dose vitamin A     supplementation is feasible and safe in pediatric and young adult bone marrow transplant     recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.   "
18819|NCT03039244|"     The study proposes to assess the effect of multiple applications of antimicrobial     Photodynamic Therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in     smokers without use of antibiotics. Twenty smokers with a clinical diagnosis of chronic     periodontitis will be treated in a split-mouth design study to either aPDT associated with     scaling and root planing (SRP) or SRP only. aPDT will be performed by using a laser light     source with 690 nm wavelength associated with a phenothiazine photosensitizer. The     applications will occur in four episodes (at days 0, 2, 7 and 14). All patients will be     monitored for 90 days. Plaque index, probing depth, clinical attachment level and bleeding on     probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the     (nsPT). Subgingival plaque samples will be collected (at baseline and 30 and 90 days after     the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA     checkerboard hybridization. Gingival crevicular fluid samples will be collected (at Day 0,     14, 30 and 90 after the nsPT) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor     Necrosis Factor alpha (Luminex) will be evaluated. Salivary cotinine levels will also be     evaluated at baseline. Data obtained will be statistically analyzed.   "
18820|NCT03039231|"     This study will test the efficacy of the Freespira Breathing System in adults with post     traumatic stress disorder (PTSD).   "
18821|NCT03039218|"     This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of     22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile     dysfunction of at least 6 months duration with low intensity extracorporeal shock wave     therapy utilizing the Dornier Aries 2 device.   "
18846|NCT03038893|"     This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep     venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with     suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of     Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was     submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.   "
18893|NCT03038269|"     The purpose of this study is to improve arm function in adults with hemiplegic cerebral     palsy. Participants will receive transcranial direct current stimulation (or sham) in     combination with upper extremity robotic therapy.   "
18822|NCT03039205|"     About 35% of patients hospitalized with Acute Coronary Syndromes (ACS) have some degree of     renal dysfunction. Chronic kidney disease (CKD) is not only associated to worse prognosis in     ACS patients, but leads also to an increased risk of bleeding, which may importantly     influence the risk-benefit ratio of antiplatelet therapy in this population. The responsible     mechanisms for increased rate of ischemic events in this population are not completely     elucidated.      Antiplatelet therapy is of paramount importance in the treatment of ACS, but its benefit in     CKD patients is not well established. This population is often excluded or underrepresented     in large clinical trials, and the indication of antiplatelet therapy is often extrapolated     from studies in patients with preserved renal function. In recent meta-analysis, Palmer et     al. sought to evaluate the benefits and risks of antiplatelet agents in patients with CKD and     concluded that in patients with ACS or scheduled for angioplasty already taking aspirin, the     addition of clopidogrel or glycoprotein IIb / IIIa inhibitors have little or no impact in     reducing the incidence of myocardial infarction, death or need for revascularization.      In the PLATO trial, ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster     onset of action and greater platelet inhibition) was compared to clopidogrel in patients with     high risk ACS and was associated to a 16% risk reduction on the occurrence of death from     vascular causes, myocardial infarction, or stroke. In a pre-specified sub-analysis, data from     patients with CKD were compared to those obtained from the population with normal renal     function and suggests that the benefit of ticagrelor may be even greater in patients with     CKD. Two hypotheses were considered to explain these results:        1. Greater and more consistent platelet inhibition achieved with ticagrelor would be more          effective in reducing ischemic events in this population at increased thrombotic risk;        2. Pleiotropic effects of ticagrelor besides inhibition of the P2Y12 receptor. Ticagrelor          might be associated with an elevation in serum levels of adenosine. This could improve          myocardial perfusion through coronary vasodilation, and this effect would be more          pronounced in patients with renal dysfunction.      This project aims to validate (or not) these hypotheses, analyzing platelet aggregation and     circulating adenosine levels in patients taking dual antiplatelet therapy with aspirin and     clopidogrel or ticagrelor.   "
18823|NCT03039192|"     The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram     (mg) compared with intranasal placebo in addition to comprehensive standard of care in     reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in     participants who are assessed to be at imminent risk for suicide, as measured by the change     from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24     hours post first dose.   "
18824|NCT03039179|"     The post-operative treatment of pediatric patients operated for the correction of flat foot,     sees today the use of preformed leg-foot splint (Walker) as an alternative to the application     of plaster casts. The change of the immobilization system has led to the appearance of     problems of tolerability in particular in the skin. The aim of the study is to assess whether     by placing a polyurethane foam dress at the heel in the immediate postoperative period until     removal of the Walker, the rate of skin lesion and pain is reduced.   "
18825|NCT03039166|"     the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as     well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on     functional dysfunction not directly related to each disease, but that could induce common     syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.      The objective here is to test this hypothesis and provides better understandings on     pathophysiological processes affecting those highly connected regions in 'diffuse' and     'focal' neurological diseases.      The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS,     cognitive rehabilitation ...).      Practically, the investigators will explore 200 patients classified in 5 cohorts of 40     patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to     assess structural and functional brain connectivity implemented on the human 7T MR scanner     equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).      In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium)     mapping will complement the MR protocol to characterize the pathophysiological processes of     hub injury. Sixty healthy controls will also be explored wih the same protocol for normal     database.      The proposal aims at characterizing and comparing from a morphological-functional point of     view, the hub regions of patients suffering from these five diseases, to demonstrate the     pertinence to preserve hub integrity as a major therapeutic target whatever the disease.   "
18826|NCT03039153|"     From the point of view of nursing to know exactly the different risk factors for the onset of     pressure ulcers is very important as it allows to accurately orient preventive care     interventions.      All the variable that could influence the development of pressure ulcer in patients     undergoing knee replacement surgery are identified and collected: age, sex, body max index,     risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology     of the devices used, such as air mattresses with alternating or static pressure, heel drains,     frequency of mobilization carried out by both the patient care), management of eventual     incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia,     length of stay, the ASA physical status classification system (ASA score), comorbidity,     cancer, use of devices for controlling the position of the operated limb (foam valve), the     number of physical therapy sessions actually carried out.   "
18827|NCT03039140|"     This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory     fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause     of death of women in both the general population and the breast cancer survivor population.     There are many risk factors common to both heart disease and breast cancer development,     including physical inactivity. A cardiac rehabilitation program may help improve     cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of     life among breast cancer survivors.   "
18828|NCT03039127|"     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a     tumor specific immunologic response. In laboratory animals the imILT method has also been     shown to induce a so called abscopal effect. This means that when one tumor is treated with     imILT other, untreated, tumors also decrease in size. The immunologic response has previously     been characterized in breast cancer patients after receiving imILT treatment , and presumed     abscopal effects induced by imILT have also been described in a malignant melanoma patient.      The purpose of this trial is to investigate the functionality and safety of the imILT     treatment method in patients diagnosed with breast cancer.      The treatment method has successfully been used for treatment of patients with breast cancer     and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T     lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border.     Regulatory T lymphocytes decreased in the regional lymph nodes.      This trial is explorative, prospective, open and non-randomized. Five breast cancer patients     will be treated in this trial, which is estimated to be carried out during a time period of 9     months.   "
18835|NCT03039036|"     Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However,     the timing is highly variable. The purpose of this study is to determine if first time     mothers undergoing induction of labor with a Foley catheter experience a decrease in their     labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley     catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least     4 hours after Foley catheter removal). Other aims include the relationship between timing of     amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar     score <7 at 5 minutes, neonatal need for intensive care.      The investigators hypothesize that induction of labor with Foley catheters followed by early     amniotomy will result in a decreased duration of labor compared to those who undergo delayed     amniotomy.   "
18836|NCT03039023|"     The investigators are interested in learning more about choline, a nutrient required by the     body. The body does make some choline, but it does not make enough to support health and the     rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary     source of choline. Choline can also be given as a dietary supplement. Ingestion of choline     supplements has been linked to an increased concentration of a compound called TMAO     (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease risk.     With this study, the investigators hope to learn whether there is a difference in the way     your body responds to the ingestion of a choline supplement versus the choline found within     eggs.   "
18837|NCT03039010|"     Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since     year 2008 gathered dental data. The data is automatically extracted from the patients'     electronical dental data records. A vast majority of the public dental health care clinics     deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop the     quality of care and patient outcomes for both prevention and reparative/restorative methods     concerning caries and periodontal disease. For children and adolescents, it is above all     information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has     published seven annual reports. In the report for year 2013 a limited information about the     status of children was given, due to uncertainty in the quality of the information that is     passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the     data supplied to SKaPa.      Tooth decay is the most common disease in children and adolescents that often lead to     invasive interventions and pain. There are reports of great social disparities in dental     health in children and adolescents in Sweden (The National Board of Health and Welfare,     Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important     to be able to monitor the occurrence of the disease and also examine how it differs across     various groups of children and adolescents. This is now possible through the several     registries that are available in the dental and health care. Register-based research will be     an important tool to ensure that children and adolescents receive oral health and dental care     on the same premise as others, provided the data in the registries are valid. Furthermore,     register-based research is important for development and quality assurance of dental care.   "
18838|NCT03038997|"     To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in     children who received anthracycline based chemotherapy (ABC).   "
18839|NCT03038984|"     This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555.     The purpose of this study is to determine if the IBD patients doing home monitoring     (screening themselves on demand (OD) or every 3 months) have relative reduced rates of     colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD     patients are self-monitoring by web apps consisting of a short disease activity questionnaire     (DA) and fecal calprotectin (FC) on any smart phone.   "
18840|NCT03038971|"     A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic     injections of 2 different dose levels of the investigational short and tall ragweed product.     Biomarkers will be assessed at baseline and at multiple time points post-treatment.   "
18841|NCT03038958|"     This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric     prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side     effects   "
18842|NCT03038945|"     Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of     the problems described for this procedure has to do with the closure of the vaginal vault,     increased surgical time when suture laparoscopically, complications such as dehiscence of the     dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare     two different techniques for closure of the vaginal vault.   "
18843|NCT03038932|"     Atopic dermatitis, also called eczema, is a disease with dry, scaly, itchy skin. Those with     atopic dermatitis may have complications from skin infections such as eczema herpeticum after     herpes simplex virus (HSV) infection. Symptoms of eczema herpeticum include fever and     clusters of itchy blisters which crust over and form sores. Although exposure to HSV is     widespread, most people clear the virus and only a subset of individuals with atopic     dermatitis develop eczema herpeticum.      The purpose of this study is to determine why some individuals with atopic dermatitis are at     higher risk for recurrent skin infections with HSV. The study team will compare how people     with atopic dermatitis with a history of recurrent eczema herpeticum, people with atopic     dermatitis without a history of eczema herpeticum, and people without atopic dermatitis     respond to HSV.   "
18844|NCT03038919|"     The researchers intend to investigate possible anabolic effects of bi-weekly exogenous     testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control     group will receive standard ICU management and will also be followed during ICU stay.   "
18845|NCT03038906|"     The proposed work will determine the effect of neuromuscular blockade on physical function     and recovery in patients with ARDS. The investigators will conduct a prospective ancillary     study at five PETAL clinical centers that will evaluate the neuromuscular structure and     function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and     after critical illness, including in-person assessments at 6 months after hospital discharge.     The investigators hypothesize that patients randomized to NMB will have an increase in     ICU-acquired neuromuscular dysfunction during and after critical illness.   "
39178|NCT02772835|"     The purpose of this study is to compare the effects of two different techniques of     non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering from     respiratory distress syndrome.   "
18848|NCT03038867|"     The investigators are conducting a placebo-controlled, randomized control trial with     duloxetine in healthy, fertile men not previously on any antidepressants. Participants will     be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will     assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes     measured will include semen parameters (sperm concentration, motility, morphology), hormone     levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)     surveys.   "
18849|NCT03038854|"     The purpose of this study is to determine the nutritional and cognitive effects of consuming     Growing Up Milks (GUMs) and cow's milk.   "
18850|NCT03038841|"     To test the potential and acceptance of wireless activity tracking in palliative care     patients leaving hospital care. Explorative study, collaboration project of the Clinic of     Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss     Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in     order to gather objective physical activity parameters as step count, sleep duration, heart     rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and     distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between     patients' physical activity patterns and the pain and distress level assessed from electronic     scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by     quantitative questionnaires and interviews. The proposed study is meant to be preparatory     work for an intervention study to test the effect of wireless monitoring of palliative care     patients on fostering early interventions for symptom relief and support of QoL.   "
18851|NCT03038828|"     Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts.     Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2     weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are     noted in cohort A patients, ten participants will be treated in cohort B. Cohort B     participants will be treated the same as cohort A participants except that dose will be     increased to 400IU Multikine per day.   "
18852|NCT03038815|"     After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle     support limit the range of motion in the joint, help pain relief, control loading of the     injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in     orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable     accurate analysis of human movement.      The study is set to describe and compare the gait analysis of two modifiable stability boots     (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions     (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.   "
18853|NCT03038802|"     This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B     virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV     infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has     confirmed this vaccine to be more effective at inducing seroconversion as measured by     development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the     standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be     able to induce HBV viral control and/or seroconversion in chronically infected subjects   "
18854|NCT03038789|"     This is a local, prospective, non-interventional, regulatory postmarketing surveillance     study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as indicated     by the Ministry of Food and Drug Safety (MFDS) will be included.   "
18855|NCT03038776|"     Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human     clinical trials. This study will test approaches to improve the immunogenicity of H7 vaccine,     namely use of a three dose regimen, use of a modified H7 HA sequence from which the Tregitope     has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the vaccine   "
18856|NCT03038763|"     The investigators aim to determine the prevalence of hepatitis C in the adult children of     female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C     testing was either not available or was not standard of care. Because of this, participants'     children may be unaware of participants' risk of hepatitis C.   "
18857|NCT03038750|"     The risk of cardiovascular disease is determined by the complex interplay between an     individual's genetic make-up, lifestyle, and the environment. We are investigating three     potential genetic risk factors in this observational, cross-sectional, epidemiology pilot     study to investigate if and how functional variants identified in large-scale genome wide     association studies can explain a predisposition to cardiovascular disease. By determining     the molecular mechanisms that are regulated at the EDNRA, PNPLA3 and PROCR CVD risk loci, we     hope to translate findings from this study into the clinical setting for better diagnosis,     prevention and treatment for patients suffering with cardiovascular disease. Volunteers will     enter into one of the study's three arms based on their genotype: EDNRA locus (Arm 1), PNPLA3     locus (Arm 2), or PROCR locus (Arm 3).      Members of the Cambridge Bioresource who match for the target alleles will be invited to     participate and will enter into one of the three study arms. All study assessment visits will     take place at Addenbrooke's Hospital in collaboration with the University of Cambridge.      Volunteers will participate in the study for a maximum of 12 months and depending on study     arm they are assigned to, they will complete procedures including a medical, demographic and     lifestyle factors questionnaire; height, weight and body fat assessments; in addition to     blood pressure/heart rate measurements. Minimally invasive procedures including forearm blood     flow and venepuncture will be performed to assess the primary objectives of the study.      The hypothesis for arm 1 is that the genetic variant we are investigating at the EDNRA gene     locus alters the function of the endothelin receptor A leading to an increased risk of     coronary artery disease and large artery stroke.      For study arm 2, we hypothesize that the genetic variant we are investigating in PNPLA3 will     increase the risk of Non-alcoholic fatty liver disease but reduce the risk of Coronary Heart     Disease.      For study arm 3, we hypothesize that the genetic variant we are investigating in the PROCR     locus triggers molecular events that potentially increase the risk of Venous     Thrombosis/Venous Thromboembolism nut reducing blood pressure. Furthermore we aim to     investigate the anti-inflammatory effects to see if there is an effect on explaining reduced     risk of CHD.      This study is funded from the BHF Cambridge Center of Excellence and the Wellcome Trust     Institutional Strategic Support Fund.   "
18858|NCT03038737|"     The aim of the present study is to evaluate the biting force of upper removable partial     denture constructed from two different flexible thermoplastic materials.   "
18859|NCT03038724|"     A randomised, single-blind study (the study investigator will not know which arm each patient     is assigned to) conducted to examine the most effective strategy for conducting HIV testing     in the Emergency Department (ED) using an electronic tablet. The study will take place in the     ED at Lausanne University Hospital (LUH) between August and December 2015 in the context of     the Masters project of a medical student studying at the Faculty of Medicine at Lausanne     University.   "
19030|NCT03036475|"     The aim of this study is to evaluate a new method for the localization of breast cancer     sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard     techniques with radio-isotopes.   "
18861|NCT03038698|"     Pulmonary function testing is the most widely used tool for the diagnosis, severity     assessment, management, risk factor categorization and follow-up of individuals with chronic     lung disease. Africa has a high burden of infectious respiratory diseases which include     tuberculosis, asthma and human immunodeficiency virus-related lung disease. Coupled with this     is an increasing burden of non-communicable respiratory diseases; which include chronic     obstructive pulmonary disease, emphysema, bronchiectasis and asthma. A proviso to the use of     lung function testing is the determination of normal values; which are determined for age,     gender, height and ethnicity for the relevant population. It is well recognised that the     comparison of an individual patients' results to an ethnically inappropriate population may     lead to the under or -over diagnosis of disease, inappropriate treatments and result in     increased burden on individuals, their families and the healthcare system.      The investigators therefore propose to conduct a prospective well-designed study to include a     representative sample of both adults and children (4000); to verify the validity of the     retrospective pilot data, in a South African population.   "
18862|NCT03038685|"     The Belgian Stroke Council initiated a project to improve risk factor control and medication     adherence in ischemic stroke patients by developing an individualized in-hospital initiated     and post- discharge, digital coaching program addition to standard practice (strokecoach.be).   "
18863|NCT03038672|"     This randomized phase II trial studies how well nivolumab with or without varlilumab works in     treating patients with aggressive B-cell lymphomas that have come back or do not respond to     treatment. Monoclonal antibodies, such as varlilumab and nivolumab, may work by stimulating     the immune system to attack cancer tumor cells.   "
18864|NCT03038659|"     Erectile dysfunction.   "
18866|NCT03038633|"     This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel     medical food utilizing a nutritional strain of yeast for management of Iron Deficiency     Anemia.   "
18867|NCT03038620|"     This study is a clinical study to investigate the efficacy of liraglutide compared to placebo     in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk     for cardiovascular disease after 40 weeks on-treatment.   "
18868|NCT03038607|"     Intrauterine growth restriction refers to a fetus that has failed to get a specific measures     by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal     sized head with smaller abdomen.It is important to recognize the growth restricted fetuses,     because these fetuses may have fetal or neonatal complications.      When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The     role of low-dose aspirin therapy in management of intrauterine growth restriction is     controversial. It has been used, in many studies, in prevention of intrauterine growth     restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid     syndrome.   "
18869|NCT03038594|"     The investigators have previously demonstrated that thermal injury causes severe muscle     wasting, weight and height retardation, and systemic protein catabolism in pediatric and     adult burned patients. The persistent loss of muscle impairs the quality of life of the     burned patients, and it also delays autonomy and reintegration into the community. In 2009,     the investigators showed that the daily injection of recombinant human growth hormone (GH)     for nine months post discharge significantly increased height and weight, as well as lean     body mass, in pediatric burned subjects. Our long-term goal is to improve the quality of life     of burn patients by preventing height, weight, and muscle loss that may occur from severe     protein catabolism. The objectives of this application are to a) attenuate height and weight     in burned patients with the administration of GH, b) prevent or reverse loss of muscle and     strength in these patients, and c) collect pilot data about cardiopulmonary parameters, scar     assessments, and muscle metabolism. Our central hypothesis is that the administration of GH     will restore depleted levels of growth hormone and will lead to prevention of lean body mass     loss and bone mineral content, improve rehabilitation, and accelerate reintegration of     severely burned patients. The investigators will administer either placebo or GH (daily     subcutaneous injections of 0.05 mg/kg/day of GH [somatropin, Genotropin, Pfizer, New York,     NY] to adult burn subjects (n=31 per group, 18-85 years, >30% total body surface burns) for     nine months beginning one week prior to discharge. Both groups will be studied for a total of     two years. The following aims will be tested: 1) determine the effects of GH supplementation     on body composition, such as lean body mass loss, muscle strength, and exercise endurance;     and 2) assess whether rehabilitation and subsequent reintegration of severely burned patients     into society can be accelerated. Investigators will measure changes in lean body mass, muscle     strength and exercise endurance during the acute hospital stay, discharge, and long-term     follow-up visits (6, 12, 18, and 24 months after discharge), as well as secondary endpoints     such as cardiopulmonary variables (resting energy expenditure, resting heart rate, cardiac     output, stroke volume, and liver size), hypertrophic scar development, muscle protein     synthesis and breakdown rates, and concentrations of relevant hormones, cytokines, and     oxidative stress markers. The proposed research is innovative because the administration of     growth hormone in adult burned patients has not been explored.   "
18870|NCT03038581|"     Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills.     There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and     compare them to traumatic wrist injuries.   "
18871|NCT03038568|"     The purpose of the study is to see how measurements of tumor differences vary with slight     changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal     tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even     in the setting of variable scan parameters and variable contrast timing. Participants will be     consented to undergo an additional CT of their abdomen.   "
18872|NCT03038555|"     Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy     (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and     proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal     anomaly and systemic multi-system organs damage. Several complications, such as eclamptic     seizures, coma, intracranial hemorrhage (ICH), cardiac failure, pneumonedema, hepatic     failure, kidney failure, placental abruption and disseminated intravascular coagulation     (DIC), may be threat to the life of the mother as well as fetal. Thus, the disease is one of     the core issues that cause the maternal and perinatal death. Morbidity of PE is approximately     3% to 5%. Morbidity has significant differences between different populations. According to     the data, from 1995 to 2004, HDCP morbidity in four hospitals in Guangzhou was 5.78%, and in     the HDCP, mild preeclampsia and severe preeclampsia were accounted for 72.22% and 27.78%     respectively. Meanwhile, HDCP morbidity decreased from 9.4% (1984 to 1989) to 5.57% (1989 to     1998).      In 1996, the American Congress of Obstetricians and Gynecologists (ACOG) gave new     classification of HDCP based on the characteristic of disease symptoms, divide into five     groups; gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated     with preeclampsia and chronic hypertension. The pathogenesis of PE remains unclear so far.     The frequent sight is that PE caused by multiple reactions by a number of factors affect.     Physiologically, mainly altered of PE is increased blood viscosity and systemic vascular     spasm which cause hypoxic-ischemic of multiple key organs, such as the placenta, kidney,     liver and brain. The research theory includes abnormal trophoblast invasion, immune response     abnormal or increase, genetic susceptibility, coagulation disorders or thrombophilia,     abnormal angiogenesis, endothelial cell damage, abnormal levels of carbonic oxide, increase     of oxygen radical, abnormal metabolism of calcium ion, heterotrophia and so on. However,     there are numbers of epidemiologic study have analyzed high risk factor of PE which provides     significant medical evidence of prevention, early diagnosis and early treatment for PE, there     is only little study focus on susceptibility gene and pathogenic genetic variation. Nowadays,     there are numerous clinical phenotype are considered to exist, different phenotype gives     different inheritance and epigenetics. Thus, our group will examine the onset of type and     characteristics of PE by a retrospective cohort study to discuss if susceptibility gene and     pathogenic genetic variation were existing in PE patients, also to find the relativity     between clinical phenotype and genotype. Moreover, this study is trying to reach the effect     of PE on the patients' health as well as their children. Thus, can predict the health status     of PE patients and their children, and so can prevent (avoid or delay) of the patients from     late complications and disease in their children.   "
18873|NCT03038542|"     This study evaluates a text messaging intervention through a smokers' quitline. Smokers will     either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored,     standard care text messages, both combined with standard quitline treatment. We hypothesize     that the gain-framed text message intervention will increase cessation rates at 30 weeks as     compared to standard care text messages.   "
18874|NCT03038529|"     Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset     amelioration of symptoms, with a sustained duration pain relief in low back pain.      Does change of injection approach make a difference?   "
18875|NCT03038516|"     To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients     can decrease opioid consumption, fatigue and infectious burden and increase quality of life.   "
18894|NCT03038256|"     The purpose of this study was to evaluate the effect of concurrent capecitabine-based     long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles     XELOX post- a Regular Timing TME in patients with high-risk rectal cancer defined by MRI.   "
19031|NCT03036462|"     The purpose of this study is to determine whether intravenous iron supplementation using     ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron     deficiency and heart failure.   "
18876|NCT03038503|"     The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6     hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid     resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate     with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with     catecholamine resistance has been studied such as terlipressin, methylene blue        -  Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C,          and increases intracellular Ca2+ concentration        -  Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme          guanylate cyclase (GC)   "
18877|NCT03038490|"     To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and     HMB for a maximum period of four weeks is more beneficial than the standard dietary approach     to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions     and length of hospitalizations for these patients.   "
18878|NCT03038477|"     This is a two-arm, open-label, phase II study of in adult patients who have successfully     undergone R0/R1 resection of PDAs following neoadjuvant chemotherapy and completion of     adjuvant chemotherapy. Within 1-3 months of treatment completion, patients will be enrolled     and randomized at a 1:1 ratio to receive durvalumab versus observation.   "
18879|NCT03038464|"     The two-stage protocol is gold standard in terms of infection control treating prosthetic     joint infections of total hip and total knee arthroplasty. The antibiotic pause for     diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of     infection and development of resistant bacterial strains. Serological markers and synovial     analysis are common use to exclude persistence of infection.      The investigators therefore asked 1) is the serological testing of c-reactive protein and     leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of     synovial aspiration of PMMA Spacers on hip and knee joints.   "
18880|NCT03038451|"     s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any     hypertension treatment before or have received any of anti-hypertensive mono-therapy for the     first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be     administered for the last four weeks (4-8 weeks).   "
18881|NCT03038425|"     This is a randomized, double-blinded pilot study to determine whether patients undergoing     ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition     of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal     approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale     (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome     as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of     catheter effectiveness, and complications.   "
18882|NCT03038412|"     The purpose of this study was to evaluate the applicability of auto-fluorescence imaging     system to detect and quantify caries and dental plaque. Participants were advised to rinse     their mouth with distilled water to exclude any chance of fluorescence from food debris. A     well trained physicist majored in optical spectroscopy captured auto-fluorescence images of     buccal aspects of two maxillary central incisors and occlusal aspects of four first molars     from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley     Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also     required to brush their teeth for 3min, then International Caries Detection and Assessment     System（ICDAS）codes of relevant teeth to evaluate degrees of caries were recorded by an     experienced dentist using a mouth mirror and explorer. The Spearman rank correlation     coefficient between colorimetric parameters of fluorescence image and the plaque index and     ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence     imaging system.   "
18883|NCT03038399|"     This long-term extension study is an open-label, multiple‑dose study to evaluate the     long‑term safety, tolerability, efficacy and PD of vamorolone administered once daily by     liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who     participated in the VBP15‑002 Phase IIa and VBP15-003 Phase IIa extension core studies.   "
18884|NCT03038386|"     Rationale: Gout is a disease with growing incidence and complexity due to increased life     expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy,     demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi     (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis is     difficult to ascertain due to sampling error (no synovial fluid acquired because the needle     was not exactly placed in the affected joint, or the location of the gout might have been     extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g.     infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This     technique allows the visualization and quantification of MSU. Although imaging modalities     such as DECT show promise in the classification of gout, the studies to date have been small     and have primarily involved people with established disease.      A study with cross-sectional design in which patients for whom the clinical questions does     this patient have gout? are referred for participation may contribute to assess the value of     DECT scan in diagnosing acute arthritis caused by gout.      Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout.      Study design: Prospective Study population: Patients with acute mono or oligo arthritis     without prior diagnosis, the rheumatologist has an indication for diagnostic needle     aspiration.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without     prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by     blind aspiration or ultra sound guided aspiration depending on the judgement of the     rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to     detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been     established and is therefore not used in daily practice. In this study all patients undergo     DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If     the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained     prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound     guided aspiration will take place, with knowledge of DECT results, followed by repeat     microscopy   "
18885|NCT03038373|"     The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes     in the morbid obese patients after laparoscopic sleeve gastrectomy.   "
18886|NCT03038360|"     CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a     novel predictive model and a diagnostic tool, for the risk stratification of AMI patients     undergoing PCI, with a one year follow-up.   "
18887|NCT03038347|"     The purpose of this study is to determine whether a web-based training program with     text-based information as well as practical exercises can improve cross-cultural competencies     in therapists.   "
18888|NCT03038334|"     This study is to examine the possible effect of supplementing Magnesium sulfate on patients     with Alzheimer Disease (AD) in controlling or reducing the amount of amyloid present in the     brain, and increasing cognitive ability in individuals that have amyloid deposits.   "
18895|NCT03038243|"     This is a research study about an experimental (investigational) oral inactivated whole cell     Shigella flexneri 2a killed vaccine (Sf2aWC) and an adjuvant called dmLT. Sf2aWC is a killed     vaccine that is being made to prevent disease from Shigella., which causes bloody, watery     diarrhea. An adjuvant is something that is added to a vaccine to make it work better. The     purpose of the study is to see if the vaccine will protect people from Shigella infection     with or without an adjuvant called dmLT. About 72 healthy adults, ages 18-45, will     participate in this study. The study will compare 2 different vaccination groups and 1     control group. Volunteers have an equal chance to be in any of the 3 groups. Study procedures     include: stool samples, blood samples and documenting side effects. Participants will be     involved in study related procedures for about 6 months.   "
18896|NCT03038230|"     This is a First-in-Human, single arm, open-label, multi-national study designed to determine     the safety, tolerability and preliminary efficacy of MCLA 117.   "
18897|NCT03038217|"     In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in     the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal     cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical     specimens, and observation of patients undergoing radical resection of the tumor with or     without adjuvant chemo- and/or radiotherapy.   "
18898|NCT03038204|"     Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for     secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these     procedures is the papillary muscles approximation. However, the safety and the positive     impact of this method are still in doubt.   "
18899|NCT03038191|"     Epilepsy is a group of neurological disorders characterized by propensity for spontaneous     epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell     activity in the brain. About 0.7-1% of the world population suffers from seizures. The most     common treatment is based on seizure medications that enables about 2/3 of the patients to     control their seizures. However, about 20 million patients worldwide, suffer from     unpredictable seizures without remedy, and are resistant to medication.      In this study EEG and other physiologic signals are collected using wearable sensors, from     Epilepsy patients who are at risk of experiencing seizures. The collected signals will be     used for developing algorithms that may identify pre-seizure and seizure related periods.   "
18900|NCT03038178|"     The proposed study will assess the efficacy, safety and tolerability of once daily dosing of     Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC)     mycobacterial multi-drug regimen in accordance with the 2007 ATS/ IDSA guidelines, for     treatment of mycobacterium abscessus lung disease.   "
18901|NCT03038165|"     While the exact pathogenesis of Intradialytic hypertension remains to be determined, several     mechanisms were proposed to be involved. The main factors to determine the arterial blood     pressure are the peripheral vascular resistance and cardiac output. The assumption is that     the increase of blood pressure is related to the increase in peripheral vascular resistance     during the dialysis session, due to fluid removal and fast reduction of the intravascular     volume reduction.      Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients     with intradialytic hypertension will be evaluated   "
18902|NCT03038152|"     The goal of this clinical research study is to learn more about the safety and effectiveness     of a marker called Magseed that is used to help participant's doctor locate lymph nodes that     contain cancer under participant's arm during surgery. The Magseed marker is a small metallic     marker (smaller than a grain of rice) which is placed in or near the lymph node by     participant's radiologist.   "
18903|NCT03038139|"     The purpose of this study is to investigate the changes of spinal muscle activation in     cervical, thoracic and lumbar segments for subjects with forward head posture (FHP) after     application of two correction programs; a conventional one including cervical and thoracic     spine, and a second program involving lumbosacral segment.   "
18904|NCT03038126|"     Home telehealth monitoring of veterans with chronic kidney disease, with a disease management     protocol and safety-specific decision support, will increase the detection of adverse safety     events, and in turn, reduce the need for urgent health resource utilization and associated     poor outcomes.   "
18905|NCT03038113|"     This randomized study will be conducted in two parts to evaluate the safety, tolerability,     pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1     will include only healthy participants and Part 2 will include only participants with chronic     hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive     dose-escalating schedule to determine the best dose to be evaluated in participants with CHB.     Part 2 is an adaptive, parallel multiple-dose study comprised of two sub-parts which will be     used to further refine the dose and dosing regimen.   "
18906|NCT03038100|"     This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the     efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo +     paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian     cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic     residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will     undergo neoadjuvant therapy followed by interval surgery.   "
18907|NCT03038087|"     The purpose of this research study is to find out whether a device for monitoring bleeding in     patients with acute hemorrhagic stroke will show similar findings as CT scans performed to     evaluate the stroke.   "
18908|NCT03037047|"     This parallel, double blind, randomized, controlled, multi-center study will evaluate the     efficacy and safety of salvianolate injection in elderly patients with unstable angina     pectoris.   "
18909|NCT03037034|"     Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive     patients who had clinical indications for lesion removal. Following the injection around a     submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled     away to form a tent. The tissue was dissected using an electrocoagulating current. In     brief, the tumor was dissected from the muscularis propria layer and then carefully removed     using forceps. Demographic data, indication for intervention, safety of the procedure and     follow‐up will be assessed.   "
18910|NCT03037021|"     The overall goal of this proposed project is to 1) increase co-management between sickle cell     specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which     prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3)     identify and link patients not receiving primary or SCD specialty care to care, and 4) shift     healthcare use from EDs and hospitalizations to primary and specialty co-management. Many     persons with SCD experience a poor quality of life, serious medical complications and     frequent painful events that require treatment from SCD specialty care, primary care and     emergency department (ED) providers. There are two dominating models of care in the United     States; neither are ideal. Many people with SCD have all of their healthcare needs addressed     by sickle cell specialists who do not typically provide primary care and are often     geographically distant from the patients' home. Other sickle cell patients receive all of     their care in EDs. Both models are inadequate and result in an alarmingly high number of ED     visits for many patients. Current care models are neither cost efficient nor promoting     optimal patient outcomes. To improve outcomes, the investigators will implement a new model     of care for SCD using nurse care managers, web based-interactive algorithms, and test if     additional patient provided coaching can improve outcomes.   "
18911|NCT03037008|"     Prospective study to evaluate a new technique. Comparison of perineal sonography in men     before and after radical prostatectomy and in incontinent men after radical prostatectomy     before and after operative treatment with male sling and comparison with pre- and     postoperative functional MRI      Inclusion / Exclusion criteria: Inclusion: male, elder than 18years, planned RALP or history     of RALP and PPSUI (Post Prostatectomy Stress Urinary Incontinence).      Exclusion: Patients with history of urinary incontinence before radical prostatectomy.     Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.   "
18912|NCT03036995|"     Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an     acquired pigmentary disorder of the skin and mucous membranes that is characterized by     circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4)     inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis.     Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to     anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes.     Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for     promoting melanogenesis and for inducing the differentiation and the proliferation of     melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of     Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo     therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo.     Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or     slowly progressive for 3 months , seeking for treatment in the Department of Dermatology,     University Hospital of Nice, France will be recruited into the study. The Patients are seen     in consultation by the investigator, selection criteria are checked. All patients will     receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks.      From W24 to W48        -  All responders* will receive narrow UVB treatment according the French clinical use          i.e.twice weekly sessions of narrowband UVB for 24 weeks.        -  All responders* will be randomized to receive either apremilast** 30mg BID or placebo.             -  Response is defined as an increase of at least 30 % in the VASI score at W24               compare to baseline **Responders initially randomized in the placebo arm will               benefit of the titration At week 24, the non responders patients will stop the               treatment and the study after the 4 weeks observationnal follow-up (W28).      Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all     subjects who complete the study (responders and non responders) or discontinue the study     early.   "
18913|NCT03036982|"     This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma     Control Test (cACT) for mobile devices improves rate of completion and improves control of     asthma in children and adolescents   "
18914|NCT03036969|"     EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:      Emergency Departments (EDs) are an important interface between primary and secondary health     care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The     reasons for ED utilization by patients with non-urgent conditions are nearly unknown in     Germany and will be investigated in this project.   "
18915|NCT03036956|"     The Precious study is likely to help determine the frequency (percentage) of subclinical     hypothyroidism among pregnant women in Pakistan It will also help to determine the risk     factors for developing subclinical hypothyroidism during pregnancy   "
18916|NCT03036943|"     The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine     (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the     differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform     further work to investigate its use in breast cancer management.   "
18917|NCT03036930|"     This phase II trial studies how well recombinant human papillomavirus nonavalent vaccine     works in preventing human papillomavirus-related cancer in adult women after kidney     transplant. Vaccines made from peptides of human papillomavirus may help the body build an     effective immune response to kill tumor cells. Giving booster vaccinations may make a     stronger immune response and prevent or delay the recurrence of cancer.   "
18918|NCT03036917|"     This study aims to investigate the cognitive function of patients in the opioid reduction     programme at the multidisciplinary pain centre at Zealand University Hospital Køge.      The patients will be tested before, halfway through, and after the programme.   "
18919|NCT03036904|"     This is a phase I, open label, single-arm, multi-center, dose-finding study of venetoclax in     combination with DA-EPOCH-R in patients with aggressive B-Cell Lymphomas.   "
18920|NCT03036891|"     The objective of this study is to evaluate the effects of naloxegol (a peripheral mu-opioid     receptor antagonist [PAMORA]) in opioid-related gastroparesis on 1) symptoms of     gastroparesis; 2) gastric emptying; and 3) pain control. The endpoints will be gastroparesis     symptoms (PAGI-SYM), gastric emptying (GEBT), and pain control (McGill Pain Inventory). The     hypothesis to be tested is that naloxegol improves symptoms of gastroparesis in patients who     are taking opioids as well as improves their gastric emptying while maintaining control of     patient's pain. This study will entail an initial double-blind, randomized,     placebo-controlled, 4-week treatment period of naloxegol vs placebo in patients with     opioid-related gastroparesis followed by a 4-week open label period to demonstrate the     improvement in symptoms and gastric emptying with naloxegol.   "
18921|NCT03036878|"     To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for     osteochondral lesions   "
18922|NCT03036865|"     Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial     conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single     ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy     adult male and female participants.   "
18924|NCT03038061|"     Position of diaphragm in the region of electrical impedance tomography measurement is to be     determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to     be obtained at three phases at supine horizontal position (during spontaneous breathing, at     mechanically ventilated patient under general anesthesia with muscle relaxation and at     mechanically ventilated patient under general anesthesia with muscle relaxation during     insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during     laparoscopic surgery).   "
18925|NCT03038048|"     We are comparing the patient experience between the standard 30 g needle to the smaller 33 g     needle for intravitreal injections of ranabizumab or aflibercept for age related macular     degeneration, diabetic macular edema, or retina vein occlusions.   "
18926|NCT03038035|"     MLC601 (Neuroaid) is a Traditional Chinese Medicine (TCM) having neuroprotective and     neuroproliferative properties in cellular and animal models of brain injury. It contains 9     herbal and 5 non-herbal components. MLC901 (Neuroaid II), a simplified formula of MLC601,     containing only the 9 herbal components yet showing the same efficacy has become available.      This study is carried out to find out if NEUROAID II (MLC901) is safe to be taken together     with other established medicines for Alzheimer's disease and whether NEUROAID II (MLC901)     helps in slowing down the Alzheimer's disease progression.      This study will be a 6-month randomized, double-blind, placebo-controlled trial, followed by     an open extension study in which all subjects who completed the main 6 month trial     (irrespective of treatment allocation) will be offered open-labelled MLC901 for another 6     months.   "
18927|NCT03038022|"     The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on     the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients     with Heterozygous Familial Hypercholesterolemia (HeFH).   "
18928|NCT03038009|"     The purpose of this study is to determine whether 12-month prophylactic treatment with     pantoprazole is superior to 1-month therapy without major cardiovascular events (MACE)     increased significantly, in prevention of dual antiplatelet therapy (DAPT)-induced upper     gastrointestinal (GI) mucosal injury after coronary artery bypass graft (CABG) surgery. The     potentially serious harm of DAPT on gastroduodenal mucosa will be assessed by     esophagogastroduodenoscopy (EGD).   "
18929|NCT03037996|"     Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take     care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of needs;     human's pleasure is classified as physiological, safety, belonging, esteem and     self-actualization. Since defining and measuring quality of healthcare service is an     inevitable challenge for all institutes in medical fields, a questionnaire is developed to     assess the quality of all services. The Siriraj Anesthesia Quality Assessment Questionnaire     (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and     convenience, Communication and Information, Process of care, Technical Quality, Psychological     support, Physical support and Royalty.   "
18930|NCT03037983|"     The purpose of this study is to determine whether repetitive transcranial magnetic     stimulation (rTMS) is effective in remediating cognitive deficits while also improving     functionality in Veterans with schizophrenia.   "
18931|NCT03037970|"     ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth     factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE     is under development for the treatment of chronic and acute wounds. This study investigates     the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).   "
18932|NCT03037957|"     A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES     Group A Strep Assay will be established through a method comparison using prospectively     collected, de-identified, clinical samples collected during the enrollment period.   "
18933|NCT03037944|"     This study aims to compare the efficacy of LNG - IUD (Levonorgestrel releasing intrauterine     device) Versus Low dose COCs (combined oral contraceptive pills) on management of heavy     menstrual bleeding and Dysmenorrhea caused by Adenomyosis.   "
18934|NCT03037931|"     The primary objective of this study is to determine the efficacy and safety of iron therapy     using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of     participants in heart failure with iron deficiency and with a reduced ejection fraction.   "
18935|NCT03037918|"     Participants will be randomly allocated to either Yakult ingestion or a control group. For     the first 20 days, subjects will consume their normal diet (keeping a detailed food diary     throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.      The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will     alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic     inflammation as well as decreasing whole body insulin sensitivity (as we have shown     previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days     before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and     prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action /     insulin sensitivity.   "
18936|NCT03037905|"     Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods     to reduce anxiety in the operating room itself. STERIS Corporation has developed an automated     surgical suite environmental system, called SignatureSuite™, that controls the level of     lighting, images on OR monitors, and ambient background audio via preset, computerized     automation for use before and after anesthesia. This study aims to determine if this new type     of operating room environment decreases anxiety, as measured by patient reports, vital signs,     and postoperative analgesic use. The proposed study will be a mixed method, two-arm,     randomized controlled trial comparing anxiety levels for patients that have thyroid or     parathyroid surgery in the SignatureSuite room at Cleveland Clinic Marymount Hospital versus     the standard operating room environment. Randomization will occur at the surgeon level. There     will be a maximum 100 patients divided equally between the experimental and control arms of     the study. Staff perceptions of the room will also be assessed at the conclusion of the     study.   "
19032|NCT03036449|"     The purpose of this study is to determine whether an educational program for caregivers     associated with convenient tools is effective to reduce medication preparation and     administration errors in the Neonatal Intensive Care Units (NICU).   "
18937|NCT03037892|"     Colonoscopy is one of the most commonly performed outpatient procedure for diagnosis and     treatment of lower gastrointestinal tract disorders. It has been largely accepted as an     effective tool for colorectal cancer(CRC) screening, given its ability to detect and remove     identified polyps. Increased colonoscopy utilization is associated with the observed decline     in the incidence of CRC and its diagnosis at earlier stages. Diagnostic and therapeutic     colonoscopy can successfully be performed using moderate sedation in the ambulatory setting.     Techniques of sedation must guarantee the comfort and safety of patients, and at the same     time allow a rapid turnover of patients.. An anaesthetic agent with rapid onset and offset of     action, and convenient titration of anaesthetic/analgesic depth as well as rapid recovery to     enable discharge from the endoscopy unit as soon as possible would be ideal as most such     procedures are performed in the Non-Operating Room Anaesthesia(NORA) settings.      There is recent interest in the use of Remifentanil, in endoscopic units as it might have     advantages over other drugs because of its profound analgesic effects, rapid onset and offset     time and rapid titration to the individual patient's requirements and intermittent pain     during colonoscopy.      The aim of this randomized study is to test the hypothesis that a colonoscopy of good quality     in terms of pain relief, patient comfort and discharge times with less cardiorespiratory side     effects can be performed using Remifentanil as a sole agent as compared with the standard     midazolam/fentanyl protocol. The second group combining Remifentanil with Midazolam is taken     to evaluate if there is any advantage of adding an anxiolytic amnesic drug as used in the     standard Midazolam/Fentanyl Protocol.   "
18938|NCT03037879|"     Multiple studies in the spinal cord injury (SCI) population have documented deficits in     learning and memory (LM) and processing speed (PS) that adversely impact daily life and the     ability to benefit from rehabilitation. The investigators have previously attributed the     cognitive deficits demonstrated in the SCI population to low blood pressure (BP) and cerebral     blood flow (CBF) and are currently conducting a study to determine the effect of a 30-day     elevation in BP (using midodrine hydrochloride - an alpha agonist) on CBF and cognitive     performance compared to placebo in hypotensive individuals with SCI. In addition, the     investigators believe that cognitive behavior therapy (CBT) may improve cognition independent     of changes in BP and CBF in individuals with SCI. The current randomized clinical trial (RCT)     will examine the efficacy of 2 treatment protocols shown to be effective in improving     cognitive performance in other neurologically impaired populations for use in persons with     SCI demonstrating (1) LM impairment and/or (2) PS impairment on objective measures of     cognitive functioning during a complete Neuropsychological assessment. Two methods of outcome     assessment will be used to examine treatment impact: (1) a traditional Neuropsychological     assessment (NP) and (2) an assessment of global functioning (AGF) composed of broader outcome     measures that examine the impact of the treatment on everyday life activities. In this way,     the investigators will be able to objectively evaluate the presence or absence of changes in     memory performance through a NP assessment, while also evaluating the impact of this     treatment protocol on everyday life through the AGF. While most studies evaluating the     efficacy of cognitive retraining usually employ a pre- and post-training evaluation, such     evaluations have been criticized for their lack of ecological validity (i.e., real world     generalizability). The present design allows the assessment of the efficacy of these     treatment techniques within an SCI population using traditional measures, as well as the     assessment of the impact that treatment has on everyday life. The investigators will     additionally evaluate the long-term efficacy by including a 6-month post-treatment follow-up.     Few studies examine long-term effects, but given the time, labor and expense involved, it is     critical to demonstrate long-term efficacy.   "
18939|NCT03037866|"     This project is designed to address the urgent need for an effective primary prevention     approach to the problem of sexual violence among college students. The project involves     developing, feasibility testing, and testing for effectiveness an innovative new approach to     the primary prevention of sexual violence, alcohol, and drug abuse among college students     utilizing both online e-learning and small group facilitator-led intervention modalities. The     intervention is an adaptation of the successful evidence-based substance abuse and violence     prevention approach called Life Skills Training (LST). The adapted intervention is designed     to address the relationship between sexual violence and substance abuse; positively change     social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to identify     and appropriately respond to problematic situations; and build social, self-regulation, and     relationship skills through interactive learning and behavioral rehearsal scenarios. At the     conclusion of the study, the investigators expect to be able to widely disseminate and market     a new evidence-based primary prevention intervention for sexual violence for use in a variety     of higher educational settings.   "
18940|NCT03037853|"     The goal is the constitution of a statistical atlas of the human being morphology     variability.      This work would be a significant step forward in the field of anatomy and biomechanical     simulation.   "
18941|NCT03037840|"     Studies have shown that tumor specific amplitude-modulated frequencies of radiofrequency     electromagnetic fields that is associated with biofeedback upon exposure to in cancer     patients. However, such discovery in other cancer patients are rare. And whether tumor     specific frequencies can be found in Asian cancer patients remains unclear. The purpose of     this study is to detect the tumor specific frequencies of Asian cancer patients in vivo.   "
18942|NCT03037827|"     A multicenter clinical randomized controlled trial, comparing of three different regimens of     endovenous laser ablation with equal linear endovenous energy density in patients with     insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED)     is the main value for standardization EVLA. From many studies, it is known the optimum value     of the LEED. However, the same LEED may be obtained by varying the ratio between the laser     power and the fiber pullback speed. Power decrease can allow to reduce the incidence of     adverse effects of endovenous laser ablation, but keep high efficiency.   "
18943|NCT03037814|"     The purpose of this study is to evaluate and compare the clinical performance of dental     restorative materials in Class II cavities of primary molar teeth   "
18944|NCT03037801|"     Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit     suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation.     The patient population will be divided into two groups, one group will receive conventional     treatment and the other group will receive conventional treatment and three times a day of     physiotherapy using Intrapulmonary Percussive Ventilation.   "
18945|NCT03037788|"     The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and     efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.   "
19118|NCT03035305|"     SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and     November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.      The objective of this study is to determine whether the association SMC and LNS reduces the     number of confirmed malaria cases among children 6-59 months during the monthly SMC     distribution sessions.   "
18946|NCT03037775|"     It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from     tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion     criteria are medical history of stroke, coronary artery disease, chronic heart failure,     hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI>     30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively     inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or     fluid without nicotine for 10 minutes. The study protocol involves random allocation to     groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary     endpoint is the maximum change in heart rate compared to mean values prior to exposure.     Secondary end points is the maximum change in the measured parameters (hemodynamic and     autonomic values) compared to the average values before exposure. The measurements will be     performed using the Task Force Monitor system for non-invasive measurement of hemodynamic     parameters and the assessment of autonomic function. Adrenergic activity will be tested with     microneurography. A periodic analysis is planned after examining 15 and 35 patients.   "
18947|NCT03037762|"     Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological     deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular     diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most     frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of     the efficacy and safety of swallowing, determination of appropriate feeding strategies and     assessment of the efficacy of different swallowing manoeuvres. The literature furthermore     indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at     evaluating findings and side effects of FEES in a heterogeneous collective of patients with     neurogenic dysphagia.   "
18948|NCT03037749|"     Intimate partner violence (IPV) is a serious public health problem costing $8.3 billion per     year with over $6 billion in direct medical and mental health costs alone. Alcohol is present     in most incidents of IPV, and contributes to more frequent and severe IPV incidents. These     facts, coupled with the fact that there are no effective interventions for IPV, make     understanding mechanisms through which alcohol is associated with IPV critical.   "
18949|NCT03037736|"     This is a randomized controlled trial of postoperative bevacizumab or 5-fluorouracil     subconjunctival injections vs placebo for the recurrence of pterygia after excision using     conjunctival autograft.   "
18950|NCT03037723|"     Radiation therapy to the breast has remained a standard practice for breast conserving     therapy. Because of the location of the heart and lungs when patients are positioned face-up,     whole breast radiation therapy has been reported to increase the risk of damage to the heart     a few years after treatment until at least 20 years after exposure, and may affect     cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an     increased risk for development of secondary lung malignancies. Recent studies have     demonstrated a significant reduction in dose to the heart and lungs when treated in the     face-down position. Similarly, correcting for the movement of breathing (respiratory gating)     in the face-up position has also become an available option for reducing unwanted dose to the     heart and lungs, particularly in left sided breast cancers. No study to date has compared     these newer organ-sparing techniques head-to-head for early stage breast cancer.      It is institutional policy to perform CT simulation in left-sided breast cancer patients with     and without the respiratory gating (this is one CT scan), in the face-up position. It is also     standard of care to perform the face-down CT simulation in large breasted women. Both of     these simulations are meant to reduce the exposure of the heart and lungs to radiation.      In this study, all left-sided breast cancer patients that consent will receive face-up CT     simulation with and without gating AND face-down CT simulation, regardless of breast size;     thus, each patient is their own control.      The treating physician will determine which of the two simulations, if any, offers better     protection to each patients' heart and lungs. Two dosimetrists will be required to     independently verify planned dosimetry with all treatment setups. Treatment will be planned     in standard fashion using the best of the two plans.   "
18951|NCT03037710|"     This is a multi-center, non-randomized, non-interventional study to evaluate the accuracy of     a remote monitoring and analytical platform for prediction of heart failure exacerbation. The     platform acquires continuous multivariate vital signs from HF patients using a new ambulatory     wearable (attached by an adhesive) multi-sensor device and analyzes the data using a novel     machine learning algorithm.   "
18952|NCT03037697|"     The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and     strapping system on increasing axial stability that will reflect on improving balance and     walking performance in children with dyskinetic cerebral palsy.   "
18953|NCT03037684|"     The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain     phenomena in neuropathic pain and chronic postoperative pain.   "
18954|NCT03037671|"     This study is designed to determine feasibility of using a continuous glucose monitor in     pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients,     and to identify the incidence and risk factors for malglycemia in primary admission for     pediatric, adolescent and young adult HSCT patients as well as to characterize the     relationship between outcomes and malglycemia in this population.   "
18955|NCT03037658|"     In this study, the investigators will test responsiveness of young, middle-aged, and older     adults to a range of incentives, some of which provide rewards for the individual     participants and others that offer rewards to other people or groups. The investigators     hypothesize that incentives are differentially effective for different age groups.   "
18956|NCT03037645|"     Phase 1b (Dose Escalation) in primarily CLL/SLL patients will evaluate safety and     pharmacology of self-administered twice a day oral doses beginning at 25 mg/dose for 4 weeks     with succeeding cohorts at escalating doses until establishing dose limiting toxicity or,     recommended Phase 2 dose. Patient data will be assessed before authorizing dose escalation     cohorts. Phase 2 (Cohort Expansion) will follow in cohorts using the recommended dose to     explore clinical activity, safety, pharmacology of SNS-062 as monotherapy.   "
18957|NCT03037632|"     The study aim of the DCM Precision Medicine Study is to test the hypothesis that DCM has a     substantial genetic basis and to evaluate the effectiveness of a family communication     intervention in improving the uptake and impact of family member clinical screening.   "
19005|NCT03036800|"     A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT)     design for subjects with severe and complex obesity who are referred to a Tier 3 or     equivalent specialist weight management/obesity service. Participants will be randomised to     receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway     (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified     stopping rules for the medication). The aim of the study is to compare the effectiveness,     budget impact, and cost-effectiveness between the two groups in a real-world setting among     otherwise largely unselected patients.   "
18958|NCT03037619|"     Patients undergoing knee replacement typically report improved health-related quality of     life, increased physical function, and reduced pain. Despite these improvements, physical     activity levels remain unchanged, or only minimally increase from pre-operative levels, yet     do not reach the same level of activity observed among healthy populations. Knee replacement     patients often expect their activity levels and function to improve following surgery, but     the majority of patients' activity levels 5 years post-operatively did not meet their     pre-operative expectations. Even though improvements are observed in pain and function,     reasons for the maintenance of low levels of activity are unknown. Technology has the     potential to increase physical activity levels in these patients, particularly as 81% of knee     replacement patients in our recent study had a smartphone, and 40% were willing to wear a     wrist-worn physical activity monitor. As the average age of knee replacement continues to     decrease, we anticipate that the percent of patients with a smartphone and willingness to     wear an activity monitor will increase. In addition to technology, social support is     associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn     physical activity monitor and providing additional opportunities for social support via the     technology may increase physical activity levels in these patients. The current pilot study     aims to gain preliminary data on the influence of wearables and social support on physical     activity in knee replacement patients following surgery. Specifically, we aim to recruit 20     patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support.     Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4     months. Participants in the Fitbit+Support group will be asked to identify a buddy. Both     the participant and buddy will be given a Fitbit and they will be asked to friend each     other via Fitbit and wear the monitor for 4 months.   "
18959|NCT03037606|"     It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed     release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in     patients with Gastroesophageal Reflux Disease (GERD).   "
18960|NCT03037593|"     Demonstrate dose-dependent relationship between vitamin D supplementation and rates of     gestational diabetes.   "
18961|NCT03037580|"     This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind,     placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary     hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).     Once randomized, subjects will take the initial dose of study drug at the study site on the     day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6,     12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.   "
18962|NCT03037567|"     The purpose of this study is to examine the acceptability and efficacy of a modified Weight     Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.   "
18963|NCT03037554|"     A home-based, sham-controlled, double-blind, crossover study evaluating the effects of     wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep     measures, proximal skin temperature, and sternal skin moisture in menopausal women     complaining of sleep disturbance and vasomotor symptoms.   "
18964|NCT03037541|"     Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as     tolerated, though local irritation often occurs within the first week of treatment and     increases in a dose-dependent manner. In this study, the investigators will examine the     combination of standard cryosurgery treatment followed by a shortened course of topical     fluorouracil cram. The investigators anticipate that a one week treatment course will     maintain overall effectiveness when combined with previous cryosurgery, but will reduce the     overall adverse effects of topical therapy due to the reduced treatment time and the presence     of fewer baseline lesions to treat. This treatment approach may provide a more acceptable     risk/benefit ratio option for patients with more extensive disease and simplify standard     combination treatment options. The primary objective is to evaluate the efficacy of     combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and     placebo in the treatment of actinic keratosis lesions. The efficacy of this combination     therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter     will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.   "
18965|NCT03037528|"     The goal of the research is to optimize an online and mobile multicomponent 12-month diet and     lifestyle intervention for improving the blood glucose control of individuals with type 2     diabetes.   "
18966|NCT03037515|"     The purpose of this project is to compare the effectiveness of two different but well     accepted routes of administration of tranexamic acid in order to reduce blood loss and need     for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks     to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing     blood loss and need for transfusion.   "
18967|NCT03037502|"     If the investigators are to adequately address the health needs of African American and     Latino men, both culture and gender must be considered when developing and implementing     strategies to increase their healthy eating and physical activity and decrease tobacco     use.The aim of this project is to develop and test gendered, culturally and contextually     relevant messages that will be used in a future, web- based tailored intervention to     encourage tobacco cessation and increase healthy eating and physical activity in African     American men. This study is part of a larger research agenda that for a decade has focused on     understanding and reducing chronic disease risk among African American and Latino men.     Because men are more likely than women to engage in over 30 behaviors known to increase their     risk of injury, morbidity, and mortality, improving men's health requires understanding the     social and cultural factors that help explain sex differences in health. Operationalizing     gender in individually-tailored health communications has great potential to unlock the     potential of health communications and interventions to engage and improve the health of men     and particularly African American and Latino men. To date, no community-based intervention     has produced clinically significant improvements in weight loss, healthy eating or physical     activity in Latino and African American men. It also is unclear how technology can be used to     promote these behaviors in this population. Thus, there is a need to develop healthy eating,     physical activity and weight loss interventions specifically targeted and tailored to African     American and Latino men that explores the utility of technology. This intervention content     and focus represents a novel strategy to promote health equity by using technology-based     health care innovations to improve healthy eating and active living by addressing a root     cause of unhealthy behavior in men: notions of manhood. The investigators focus on gender and     manhood because they are under-explored factors that shape men's health behaviors.   "
18968|NCT03037489|"     This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety     and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).   "
18969|NCT03037476|"     This research will adapt an evidence based intervention for alcohol and other drugs and     evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in web-based and     in-person formats for use with college students who have misused PSMs.   "
18970|NCT03037463|"     The purpose of this study is to assess whether tear secretion in patients with Parkinson's     disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that     will be reflected in changes in the protein composition of tear fluid, which can be measured     relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected     from Parkinson's patients, and through biochemical assays, the profile of proteins in tears     will be characterized and compared to that from control subjects. The profiles will be     analyzed with respect to any differences between Parkinson's patients and control subjects.     If differences appear, the levels of these potential biomarkers in Parkinson's patients will     be compared to the severity of their disease.   "
18971|NCT03037450|"     Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of     the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several     corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring,     neovascularization, thinning, perforation or infection. An important and permanent visual     loss of is frequently associated with the condition. NK can be congenital or acquired. Its     acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic     causes. There is currently no specific medical treatment. Surgical reconstruction techniques     of sensory neurotizations have recently been described in young patients suffering traumatic,     congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural     nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve     segment into a tissue to reestablish either motor or sensory innervation. The aim of the     present study is to assess the outcomes of a novel sensory neurotization technique for the     treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal     neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve     (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of     the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3     centimeters) will be made in one or both eyebrow and an endoscopic device will help the     surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be     sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious,     traumatic or iatrogenic causes will be included.   "
18972|NCT03037437|"     The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when     compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ     would lead to disease stability in patients with advanced hepatocellular cancer (HCC).   "
18973|NCT03037424|"     This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded,     non-inferiority phase 3 trial in adult cardiac surgical patients. Up to 12 Canadian hospitals     will participate, and the trial will require up to 2 years for patient recruitment.      Twelve-hundred bleeding adult cardiac surgical patients who require fibrinogen     supplementation due to acquired hypofibrinogenemia after CPB will be included. Patients will     be randomized to receive equivalent doses of either fibrinogen concentrate (Octafibrin) or     cryoprecipitate when the blood bank receives the first order for fibrinogen supplementation     and deems it to be in accordance with accepted clinical standards. Thereafter, patients will     be treated according to their assigned group each time fibrinogen supplementation is ordered     during the treatment period (24 hours after termination of CPB). No other aspects of care     will be modified.      The primary efficacy outcome will be the number of Allogeneic blood products (ABP) (red blood     cells [RBCs], pooled or apheresis platelets, and plasma) administered during the first 24     hours after termination of CPB. Safety outcomes will be measured for the first 28 days after     surgery, which is the duration of participation of each patient in the trial. Comparisons     will be by intention-to-treat (ITT) (primary) and per-protocol (PP) analysis. One interim     analysis will be conducted after 600 patients have been treated to determine whether the     study should be terminated for safety reasons, demonstrated non-inferiority or futility     reasons.   "
18974|NCT03037411|"     The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up     (PMCF) trial providing additional data including health economics data to support the use of     the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.   "
18975|NCT03037398|"     The objective of this study is to evaluate the performance of novel DBS programming methods     compared to traditional programming methods.   "
18977|NCT03037372|"     This study will determine whether 36 months of daily atorvastatin or rosuvastatin have     equivalent effects in reduction of immune activation, inflammation and immune aging, when     given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort   "
18978|NCT03037359|"     This is a safety study to evaluate the risk of low blood pressure in subjects with Primary     Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under     real world conditions. No study medication will be provided to subjects in this study. Study     physicians will make all treatment decisions according to their usual practice and will     provide prescriptions for his/her subjects, as appropriate. The only addition is the     collection and structured documentation of data generated through usual practice.   "
18979|NCT03037346|"     The goal of this research study is to learn how well MD Anderson helps patients and their     families select and prepare an MPOA. Researchers want to find out if social work counseling     and education help to increase the number of patients who complete MPOA documents. They also     want to study how counseling and education affects attitudes about medical decision-making,     and willingness to take part in these kinds of conversations for patients and their family     members and/or caregivers.   "
18980|NCT03037333|"     A lot of questions about use of temporary transvenous pacing still remain obscure and there     is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram     in patients with bradicardias. The aim of the study is to evaluate how long does it take to     start the correct cardiac stimulation with transvenous pacing in patients with bradicardias     comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of     complications between two methods.   "
18981|NCT03037320|"     Comparison of Coronally advanced flap with semilunar vestibular incision technique for root     coverage in patients with multiple gingival recession in maxillary teeth.   "
18982|NCT03037307|"     The objective of this study will be to compare bite force (BF) measurements over a 12-hour     period of a currently marketed denture adhesive cream based on carbomer technology (test),     with a positive control and a negative/no treatment control.   "
19275|NCT03033238|"     The purpose of this study is to investigate opportunities for prevention and treatment of     knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and     poor pain and physical function outcomes especially among those with early or mild knee     symptoms. The goal of the study is to find novel strategies to prevent disease at an early     stage and to limit the impact of disease once it has occurred.   "
19138|NCT03035045|"     This randomized controlled trial, compares perioperative and postoperative pain score by     using visual analog scale in pregnant women undergoing amniocentesis. The experimental group     will be given oral paracetamol premedication whereas the controlled group will be given oral     placebo premedication.   "
18983|NCT03037294|"     Rationale: Osteoarthritis (OA) of the knee is a common cause of pain and disability,     especially in people over the age of 65. In the current health care system both conservative     (e.g. intra-articular injections with corticosteroids) and surgical (total knee replacement,     TKR) treatment are applied. Although frequently used, certain effects of these treatments on     protein metabolism remain unclear. It is well known that maintenance of different tissues is     determined by a dynamic balance between protein synthesis and breakdown rates, with temporary     changes in either protein synthesis or breakdown allowing net protein accretion or loss.     However, intra-articular injections with corticosteroids as a conservative treatment are     thought to have several negative consequences thereby potentially affecting protein     metabolism of different musculoskeletal tissues. In addition, though protein supplementation     has shown to be an effective nutritional strategy in stimulating muscle protein synthesis, it     remains unclear to what extent other musculoskeletal tissues are able to respond to dietary     protein supplementation. Therefore, the current study assesses the impact of intra-articular     corticosteroid injections and preoperative protein supplementation on protein synthesis in     different musculoskeletal tissues of the knee.      Objective: To investigate the effect of preoperative protein supplementation and     corticosteroid injections on Hoffa's fat pad, synovium, tendon, bone, muscle, ligament,     menisci, and cartilage protein synthesis of the OA knee.      Study design: Randomized, parallel (three groups) study design. Each of the two intervention     groups will be compared to the control group separately.      Study population: 36 adults (45-75 y) with OA of the knee undergoing TKR. Intervention:     Intra-articular injection of betamethasone (2ml; 4mg/ml) and bupivacaine (8ml; 5mg/ml) or     daily 40 g of pre-sleep protein two weeks before TKR, or no intervention.      Main study parameters/endpoints: Primary study parameters include protein synthesis rates and     enrichments of Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and     cartilage. Secondary parameters include whole-body protein synthesis, breakdown, oxidation,     and net balance.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The risks involved in participating in this study are minimal. There are no     potential effects known for the ingestion of protein. The corticosteroid injection is     standard care in conservative treatment of osteoarthritis. Risks are small and limited to the     knee itself, such as cartilage degeneration or joint destruction. Muscle biopsies and tissue     collection will be performed during the surgical procedure.   "
18984|NCT03037281|"     Nociceptin is a protein found in the body, with a number of functions in the central nervous     system, blood vessels and the gut. There is evidence that it may have a role in controlling     the immune response to infection, and may act as a link between the brain and immune system.      In infection, or after surgery, there is an increase in nociceptin, and subjects greater     elevations of nociceptin have a poorer outcome. There is evidence that cells of the immune     system may produce nociceptin, although it is not yet known which cells are capable of     producing it, and what switches on production.      This study aims to determine        1. Which cells of the immune system can produce nociceptin        2. If there is a difference in the ability to produce nociceptin between healthy volunteers          and patients with severe infections   "
18985|NCT03037268|"     1. Establish the quality of fundus images produced by plenoptic ophthalmoscopy using the          grading system proposed and utilized in the Fundus Photography versus Ophthalmoscopy          Trials Outcomes in the Emergency Department (FOTO-ED) Study.        2. Determine diagnostic utility of plenoptic ophthalmoscopy images by comparing masked          image reviewers' quality measurements and findings to images obtained with a          commercially available ocular fundus camera and documented exam findings   "
18986|NCT03037255|"     This study aims to determine the extent to which pre-existing long-term conditions are     associated with survival following a heart attack (acute myocardial infarction) using     observational data from the UK's national heart attack register.   "
18987|NCT03037242|"     The results of this study will optimize the care for patients with a meniscus root tear.     Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout     technique is an effective treatment and will identify potential risk factors for poor     clinical outcomes. In addition, investigators will determine if MRR is successful in delaying     the radiographic progression of arthritis in the involved compartment.   "
18988|NCT03037229|"     Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the     identification of STEMI (ST Elevation Myocardial Infarction).   "
18989|NCT03037216|"     The purpose of this study is to find out whether exercise training leads to changes in the     blood that are produced by exercised muscles and if these changes produce new hormones that     affect the body's regulation of sugar and body weight.   "
18991|NCT03037190|"     The overall aim of this project is to investigate whether a gluten free diet after the onset     of type 1 diabetes (T1D) can better preserve the remaining beta cell mass and at the same     time prevent the development of Celiac Disease (CD) in these patients.      Specific aims      • To study whether gluten free diet during one year after the onset of diabetes influence the     appearance and duration of clinical remission in children with Type 1 diabetes.      New data show that a gluten free diet is beneficial concerning the insulin production after     the onset of diabetes. The investigators want to investigate if gluten is a triggering     protein for the destruction of the beta cell function after the onset of diabetes by     comparing children who have a normal diet compared to children with a gluten free diet during     one year after the onset of the disease.        -  To study whether a gluten free diet during one year after the onset of diabetes prevent          the development of Celiac Disease in these children and the impact of having two          diseases It is known that it is almost 10 times more common that children with Type 1          Diabetes (IDDM) develop Celiac Disease (CD) than the general population and that most of          these children (6-7 %) develop CD after the onset of Diabetes and within 5 years. Based          on our new data that CD is preventable to some extent the investigators plan to perform          randomized controlled studies if it is possible to prevent or postpone CD by means after          the onset of IDDM.        -  To investigate the impact of gluten free diet on the regulation of autoimmune responses          The investigators will test the hypothesis that gluten free diet in children with recent          onset T1D will implement immune regulation and inhibit the activation of potentially          autoreactive T cells.   "
18992|NCT03037177|"     Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical     Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the     literature. Investigators report the clinical characteristics and outcomes of a large     retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a     consensus established for the diagnosis.   "
19018|NCT03036631|"     The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions     whether sedation with intubation and paralytics is feasible and whether it delays the time to     recanalization in comparison with conscious sedation alone. As a pilot registry, it is     anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18     months. Following enrollment, data will be collected prospectively from medical records and     from patients' visits.   "
19139|NCT03035032|"     The objective of this study is to evaluate the safety, efficacy, and impact on quality of     life (QoL) of ELIGARD® in hormone-dependent prostate cancer patients in Asia.   "
18993|NCT03037164|"     Stage A: To evaluate the safety and efficacy of the INTERCEPT Blood System for Red Blood     Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in adult patients     who require RBC transfusion support.      Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in     regions where a substantial proportion of the population has been infected or is at risk of     infection by the Zika virus (ZIKV), and the risk of asymptomatic infection among qualified     blood donors is recognized. Besides the reduction of risk of transfusion transmitted ZIKV,     the intent of the study is also to reduce the risk of transfusion-transmitted infections     (TTI) in general, including transfusion related sepsis and other emerging or concurrent     endemic pathogens (e.g. Dengue and Chikungunya), and to reduce the risk of TA-GVHD.      As part of this treatment use study, additional data will be provided on the safety of     INTERCEPT-treated RBCs (IBS RBCs) supplied for routine clinical transfusion practice.   "
18994|NCT03037151|"     This study will evaluate the safety and efficacy of combination treatment with grazoprevir +     elbasvir for compensated cirrhotic participants with chronic genotype 1 (GT1) and genotype 6     (GT6) hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV)     infection.   "
18995|NCT03037138|"     Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The     aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis     washed-out state.   "
18996|NCT03037125|"     Split crest technique is a technique for horizontal bone augmentation used in case of narrow     alveolar ridges as an alternative to the more aggressive techniques such as onlay bone     grafting, guided bone regeneration (GBR) and distraction osteogenesis      The study goal is to evaluate whether if there will be any benefit of using platelet rich     fibrin (PRF) with the split crest technique regarding bone width gain and healing response in     comparison with split crest technique alone, where PRF is considered an autologous, growth     factor containing material which is easy to collect and is of low cost.   "
18997|NCT03037112|"     Antibiotic overuse and misuse contributes to the development of antibiotic resistant     infections and adverse drug reactions. The majority of all antibiotic prescribing occurs in     outpatient settings; most of which are for respiratory illnesses. It is estimated that 50% of     these prescriptions are unnecessary. The most important factor that leads to overprescribing     is inadequate parent-provider communication. This study will recruit providers and eligible     parents of children 1-5 years of age. Parents in both arms will receive identical brief     antibiotic education via tablet computers. Providers will be randomized to the     parent-provider education or communication skills intervention arm and trained accordingly.     Parent data will be collected via a tablet computer RedCap survey administered in the exam     room prior and immediately following the child's visit. Additional data will be garnered from     the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with     parents (re-visits and adverse drug reactions).   "
18998|NCT03037099|"     The main purpose of this study is to examine the effectiveness of enhanced GI-targeted     nutrition education on dietary behaviour and intakes among adults with type 2 diabetes.     Sixty-six eligible participants will be randomized into two equal groups using a pragmatic     randomized controlled trial design.   "
18999|NCT03037086|"     MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1     expression and to assess the clinical characteristics and outcomes among NSCLC patients   "
19000|NCT03037073|"     For >60 years, succinylcholine is still being administered as a selective relaxant for rapid     sequence intubation by anesthesiologists in many countries. It has been shown to possess     unique features such as low cost, fast-acting, short half-life, safe metabolites, and causing     excellent muscle relaxation for intubation. It has many side effects as well. Postoperative     myalgia (POM), with an incidence rate of ~41%-92%, is one of the most common side effects of     this drug and can take several days to cause significant discomfort in patients. However, its     effect is felt more in the throat, neck, shoulder, and abdominal muscles and is common among     patients with outpatient surgery. Due to its unknown real context of pathogenesis and in an     effort to reduce the incidence and severity of succinylcholine-induced myalgia, various     medications including nondepolarizing muscle relaxants, benzodiazepines, magnesium sulfate,     opioids, gabapentin, and nonsteroidal anti-inflammatory drugs have been tested, with varying     degrees of success.      Duloxetine is an US Food and Drug Administration-approved analgesic used for various pain     syndromes, including diabetic peripheral neuropathy and fibromyalgia. The underlying     mechanism for duloxetine against these pain syndromes remains unclear, but it may involve     three major central nervous system (CNS) targets: (1) serotonin transporter (Ki, 4.6 nM), (2)     norepinephrine transporter (Ki, 16 nM), and (3) dopamine transporter (Ki, 370 nM). In the     past, the antidepressant action was often thought to be the primary mechanism for its     analgesic efficacy. This theory was addressed later by Path Analysis, and the result showed     that duloxetine affects pain directly rather than indirectly through mood improvement. In     addition to these multiple CNS targets, duloxetine, like the antidepressant amitriptyline and     the local anesthetic bupivacaine, blocks voltage-gated Na+ channels. Because neuronal Na+     channels are present in both CNS and peripheral nervous systems, such a finding expands the     possible analgesic action and locus of duloxetine.   "
19001|NCT03037060|"     There is a need to better understand the mechanisms underlying alcohol use and dependence in     order to advance the clinical treatment of alcohol dependence. Here, the investigators will     use Positron Emission Tomography to determine if there is an up-regulation of D3 receptors in     the brains of subjects with alcohol use disorders. The investigators will also investigate     the relationship between D3 binding and major phenotypes associated with alcohol use     disorders, namely: alcohol cue induced craving and motivation to self-administer alcohol in     the laboratory.   "
19002|NCT03036839|"     The primary objectives of this study are to evaluate the safety, efficacy and tolerability of     treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus (HCV)     infection who are on dialysis for End Stage Renal Disease (ESRD).   "
19003|NCT03036826|"     Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost     renal function and continuous renal replacement therapy is nearly impossible without     measuring the drug concentration in blood samples. In many hospitals that is not an option.     The investigators aim to show, that computer based calculation can avoid over- or     under-dosing.   "
19004|NCT03036813|"     A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440     Administered Orally to Patients With Sickle Cell Disease   "
19086|NCT03035747|"     Ongoing registration of patients with varicose veins disease treated by means of conventional     surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods   "
19087|NCT03035734|"     Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to     healthy female subjects of non-childbearing potential and healthy males.   "
19006|NCT03036787|"     Infant born preterm have an increased risk of adverse long-term developmental outcomes.The     risk associated with preterm birth increase as gestational age decreases, and vulnerability     remains in extremely- very preterm (<32 weeks) and moderate- late preterm (>32 weeks). There     are many studies in the literature showed that the prevalence of developmental delay     increases with premature birth. However, there is no study in the literature investigates     long term follow up motor and cognitive development in subgroups of preterm infants . Hence     the aim of this study is to evaluate the differences in motor and cognitive development in     moderate-late (>32 weeks) and extremely-very preterm infants.   "
19007|NCT03036774|"     The main objective is to compare the frequency of a  full stomach  in diabetic patients     compared with a control population, all the patients having followed the instructions of     preoperative fast.   "
19008|NCT03036761|"     The aim of the study is to show that auriculotherapy decreases the number of days with     painful episodes of migraine and headache after 3 months of treatment   "
19009|NCT03036748|"     The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing     renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant     recipients with proteinuria compared to normoalbuminuric transplant patients.   "
19010|NCT03036735|"     The study is designed to evaluate if addition of the steroid to the spacer / stent will     improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.   "
19011|NCT03036722|"     This proposed randomized double blinded, placebo-controlled, parallel trial; with two arms,     in females aged 50-70 years, volunteers will be postmenopausal with a BMI between 25-35     kg/m2. This study aims to determine the benefits of phytoestrogen-rich flaxseeds on     decreasing bone turnover in postmenopausal women aged over 50 years.   "
19012|NCT03036709|"     This is a placebo-controlled clinical trial of VRC01 administration and analytic treatment     interruption (ATI) in adults who began antiretroviral therapy (ART) during early acute HIV     infection (Fiebig stage I to III). Eligible volunteers will be randomized in a 3:1 ratio to     either VRC01 or placebo, with randomization stratified by Fiebig stage. Volunteers who are     receiving ART with a non-nucleoside reverse transcriptase inhibitor (NNRTI) will undergo 4     weeks of protease inhibitor (PI) substitution for their NNRTI prior to randomization. ATI     will begin the day of the first dose of either VRC01 or placebo. Participants will be     monitored closely for HIV viremia and other pre-defined criteria for ART resumption.     Administration of the study agent (VRC01) every three weeks will be discontinued after 24     weeks or if ART is resumed, whichever occurs first. Volunteers who remain virally suppressed     without laboratory or clinical indication for ART resumption at 24 weeks will continue     intensive monitoring for ART resumption criteria for an additional 24 weeks, during which     time no VRC01 or placebo will be administered.   "
19013|NCT03036696|"     Interview pregnant and lactating mothers in the Gainesville, FL area to optimize; clinical     study recruitment and retention, patient-centered outcomes, and stool collection procedures.   "
19014|NCT03036683|"     This study investigates the effect of upregulating prefrontal cortex activity on risk-taking,     and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized     controlled trial, using a within-subject crossover design, each participant will undergo     anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex     and sham stimulation. After each stimulation session, neural activity and behavioral     responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect     of tDCS on violent offenders will also be assessed in comparison to age and gender-matched     healthy controls.   "
19015|NCT03036670|"     EGPA (Eosinophilic Granulomatosis with Polyangiitis, previously Churg-Strauss syndrome) is a     rare vasculitis, characterised by asthma, rhinosinusitis and eosinophilia. There has     previously been confusion around diagnostic criteria, with multiple sets of classification     criteria being used inappropriately for diagnosis. The ERS formed a taskforce to produce     specific diagnostic criteria, and these divided the Churg-Strauss Syndrome cohort into two     groups - vasculitic EGPA and tissular Hypereosinophilic Asthma with Systemic Manifestations     (HASM). It is not known if the groups separated by the diagnostic criteria are also separated     in clinical symptomatology, or if their disease course varies, and this could have     significant impact on management and further research.   "
19016|NCT03036657|"     Thus study aims to characterize the local, nerve-specific effects of acupuncture on the     median and ulnar nerves in the forearm, using nerve conduction studies and quantitative     sensory testing. All participant will have carpal tunnel syndrome and the affected median     nerve will be compared to the healthy ulnar nerve. Additionally, we aim to compare the local,     nerve-specific effect of manual acupuncture to that of low-frequency electroacupuncture and     of high-frequency electroacupuncture.   "
19017|NCT03036644|"     Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid     (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly,     nicotine to form an aerosol (vapor) that is inhaled (i.e. vaped). Scarce and conflicting     data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to     determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization     at high temperature in comparison to tobacco cigarette smoking on several advanced     cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers.     Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be     quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative     stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the     first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco     cigarette smoking on the cardiovascular system in relation to vaporization temperature,     nicotine delivery and oxidative stress.      Aims of the study: This study tests the following hypotheses: 1) acute high temperature     vaporization of propylene glycol and vegetable glycerin has no deleterious effects on     cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma     and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping     don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases     superoxide anion production.   "
19088|NCT03035721|"     This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy     full-term infants by investigating effects on growth and gastrointestinal tolerance and by     identifying any adverse effects.   "
19019|NCT03036618|"     Quinoa is possible alternative to wheat, corn and rice due to its high nutritional value and     possible properties against cardiovascular diseases and for improving gut health. There are     some animal studies to suggest that some important class of compounds like fibre,     antioxidants and protein, found naturally in quinoa, have beneficial effects against markers     of cardiovascular diseases. However, the effects of quinoa on humans has rarely been     investigated. This study will investigate the effects of daily consumption of quinoa for four     weeks on markers of cardiovascular risk, including blood cholesterol and resting blood     pressure, and on gut health in a randomised cross-over study design.   "
19020|NCT03036605|"     Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis,     prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to     pain, therefore the most common problems after surgery are postoperative pain and anxiety     during removal of the nasal packing. Lots of methods have been tried to control this pain     (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics,     local anesthetics infiltration into nasal packing).      Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain.     Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong     analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces     postoperative nausea and vomiting incidance.   "
19021|NCT03036592|"     The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B)     single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the     deleterious effect in a vulnerable population with regular exposure to concurrent high     melatonin and food intake as late night eaters (those having dinner within 2.5 h before their     usual bed time). With the results from this study, we expect to advance our understanding of     the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of     the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of     type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.   "
19022|NCT03036579|"     This investigation will be a clinical trial to study the performance of a newly developed     high strength ceramic material for crowns. The ceramic has been approved by the FDA for     patient treatment. A computer technique will be used to fabricate the crowns in a single     appointment without the need for a temporary crown or second appointment. Two adhesive resin     cement techniques will be used to hold the crown to the tooth and they will be evaluated for     creating sensitivity to the tooth. The purpose of the study is to measure how well the high     strength crowns function over an extended period of time.   "
19023|NCT03036566|"     This investigation will be a clinical trial to study the performance of a high strength     ceramic material for bridges to replace missing teeth. The ceramic material has been approved     by the FDA for patient treatment. A computer technique will be used to make the bridges. The     bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The     bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3     years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure     how well the high strength bridges function over an extended period of time.   "
19024|NCT03036553|"     Chronic musculoskeletal pain (CMP) is highly prevalent, disabling, and with high     socio-economic costs, with many negative effects on quality of life. CMP affects the ability     to perform work, social, recreational and domestic tasks, changing the mood and concentration     of this population. Despite the worldwide prevalence and socioeconomic burden of CMP, a clear     understanding of its etiology and pathogenesis remains elusive.      Aims:      (i) to analyze the possible level of association between pain-related fear, fear of movement,     self-efficacy, and pain acceptance with pain intensity and disability at the start of the     study and prospectively evaluate its predictive function; (ii) to evaluate the possible     mediating role of fear of movement and self-efficacy in the relationship between     pain-disability in patients with CMP.   "
19025|NCT03036540|"     The patients admitted in hospital who had midline catheter inserted in upper limb are     followed-up for the presence of complications related to catheter introductions. The symptoms     and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography     examination. In the selected group of asymptomatic patients sonography examination is done 8     to 10 days after cathether insertion in order to detect the incidence of the asymptomatic     thrombosis   "
19026|NCT03036527|"     Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting     quality of life after spinal cord injury. The insights of how activity-based training affects     bladder function may prove to be useful to other patient populations with bladder and sexual     dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate     investigations of training's effects within other systems such as bowel dysfunction.     Locomotor training could help promote functional recovery and any insights gained from these     studies will enhance further investigation of the effect of bladder functioning after spinal     cord injury. In addition, as suggested by a study of one of our initial participants, a     reduction in the use and/or dosage of medication to enhance sexual function is a possible     outcome, medications which carry risks and side effects.   "
19027|NCT03036514|"     In this study, numeric rating scale (NRS) and side effects are measured after usage of a     sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled     analgesia (PCIA).   "
19028|NCT03036501|"     This is an open-label, non-randomized study investigating the excretion balance, PK and     metabolism of a single oral dose of [14C]-labeled RO7034067 in healthy male participants.     This study will assess the characterize mass balance, routes and rates of elimination of     [14C]-labeled RO7034067, using conventional analytical methods and assess the     pharmacokinetics of total drug related [14C]-radioactivity, RO7034067 and its metabolite(s).   "
19089|NCT03035708|"     This study is a double-blind, randomized, placebo-controlled, parallel group, two-site study     designed to assess the effects of varenicline as compared with placebo on responses to in     vivo alcohol cue exposure in the human laboratory setting.   "
19090|NCT03035695|"     The aim of this study was to evaluate the efficacy and safety to use external haemostatic     between Axiostat® (Chitosan haemostatic dressing) and conventional cotton gauze dressing as a     pre hospital acute hemorrhagic control in trauma in ambulance settings.   "
19091|NCT03035682|"     The purpose of this study is to determine the impact a mobile health application has on     adherence to a physical therapy home exercise program and its effect on functional outcomes.   "
19033|NCT03036436|"     Participants will take part in a 12 week intervention, with at least one follow up at 24 +/-     2 weeks. Each participant will be provided with support, motivation and professional guidance     about improving physical activity (PA) levels and will be given a commercially available PA     tracker. The PA tracker will also include a smartphone or web-based application, where     participants can upload their exercise performed each day, and keep up to date with their     goals using their smartphone or by logging on to their computer. The aim of the study is to     find out how useful and effective technology with support from a healthcare professional is     in helping cancer survivors to become more physically active.      This study will measure objective PA levels of the participants at the start of the study and     at the end. The acceptability of using this intervention to promote PA in cancer survivors     will also be investigated.   "
19034|NCT03036423|"     The purpose of this study is to test whether certain brain training activities can promote     cognitive, emotional, and physical health in caregivers of a spouse with dementia. Numerous     studies show that family dementia caregiving can be stressful, and can increase mental and     physical health risks. This study aims to understand how to reduce those risks.   "
19035|NCT03036410|"     Communication on telephone is challenging for people with hearing loss. For hearing aid     users, for instance, the inventions for improving speech intelligibility on the phone range     from an integrated tele coil and individual hearing programs to specially designed phone     devices. No formal studies involving these devices have been carried out with CI users.      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate     different hearing solutions for communication on telephone in terms of intelligibility and     ease of use.   "
19036|NCT03036397|"     Background:      Arginine vasopressin (AVP) is a hormone made in the body. It can make negative feelings     stronger. The way AVP is regulated may be abnormal in people who have mood and anxiety     disorders. SRX246 is a new drug that can block a receptor for AVP on brain cells. Researchers     want to study how this drug affects the way people respond to threat and anxiety.      Objectives:      To see if the new drug SRX246 affects how people respond to the threat of an unpleasant     shock.      Eligibility:      Healthy adults ages 21-50      Design:      Participants will be screened in another protocol.      Participants will have 4 visits over 4 weeks.      At visit 1, participants will have small electrodes taped to their arm to give shocks.     Electrodes on the arm, chest, and face will measure sweat, heart rate, and blinking.     Participants will hear loud noises and get test shocks for about 15 minutes.      At the other 3 visits, participants will have some or all of these tests:        -  Blood and urine tests        -  Heart tests        -  Suicide screen      At each visit, participants will answer questions about their mood and anxiety. They will     identify emotions in pictures. They will have shock testing for 40 minutes: they will hear     loud sounds through headphones and get shocks.      Participants will take the study pill 2 times a day for a week after visit 1 and a week after     visit 3. One week it will be SRX246. The other week it will be a placebo.      Participants may be contacted daily to remind them to take the medicine.      Participants will have either a follow-up visit or follow-up phone call.   "
19037|NCT03036384|"     Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly     used for spinal injection in cesarean section. Nevertheless, its use often results in a long     duration of motor nerve block and a haemodynamical instability. Recently developped, the     Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for     hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for     intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the     effect of the local anesthetics while decreasing their dose-related side effects, the aim of     this study is to determine the ED95 of hyperbaric prilocain 2% with sufentanyl for scheduled     cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)   "
19038|NCT03036371|"     The goal of this pilot study is to test the procedural aspects of the behavioral tests and     the exercise components of the study. This includes establishing typical scores for anxiety     patients in these behavioral tests, and administering and coaching anxiety patients in an     at-home exercise regimen. This pilot study will produce the information necessary to design a     larger future study including both patients and healthy control participants.   "
19039|NCT03036358|"     The effect of teledermatology on length of hospital admission, length of stay, 30 day     readmission rate, and antibiotic use in patients presenting with cellulitis vs     pseudocellulitis in an academic emergency department setting.   "
19092|NCT03035669|"     The present study will investigate the effects of a mindfulness training on emotion     regulation and social cognition, using several psychological, behavioral, psychophysiological     and neuroimaging methods.   "
19040|NCT03036345|"     Surgery to the shoulder may be performed with patients seated upright in a position known as     the Beach Chair Position (BCP). This position has certain advantages compared to     alternative surgical positions (e.g. side lying) in some situations. However, it has been     found that surgery in the BCP can temporarily decrease the amount of oxygen in the brain as a     result of the combined effects of gravity and anaesthesia. This can result in complications     following surgery such as some memory loss and confusion. Rarely, more serious complications     have been reported in the past including death and stroke.      Due to these reported complications the use of cerebral oximetry during shoulder surgery in     the BCP has become more common. Before and during surgery, a monitor placed on the patients     forehead measures the amount of oxygen present in the brain to help control this to an     acceptable level. A number of monitors are now commercially available. Two monitors are     commonly discussed in the literature; the INVOS™ 5100 and the FORE-SIGHT® machines. However,     the actual relationship between the supply of oxygen to the brain during surgery and the     chance of later developing problems with memory and thinking (known as post operative     cognitive decline - POCD) is not clear. It is also not known if one monitor is more accurate     than another at predicting these complications.      Therefore, the main aim of this study is to examine the relationship between cerebral oxygen     levels during shoulder surgery and the incidence of POCD (i.e. problems with memory and     thinking). A second aim is to compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to     measure cerebral oxygen and cerebral desaturation events (CDEs) as well as the importance of     other key clinical variables (e.g. blood pressure, nausea, body fat etc).   "
19041|NCT03036332|"     The present study aimed to determine the effects of 16 weeks of aerobic interval training on     quality of life and a set of clinical biomarkers.   "
19042|NCT03036319|"     As individuals grow older, a number of factors can reduce our cognitive (or thinking)     abilities such as normal aging, neurodegenerative diseases, and cardiovascular disease.     This study will evaluate whether cognitive rehabilitation and transcranial electrical     stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods     that are used to improve tasks people have trouble doing in everyday life. Transcranial     electrical stimulation uses small amounts of electricity to try to alter brain functioning.     These approaches may help improve cognitive abilities like attention, learning, memory,     finding words, and problem solving as well as everyday functioning. The goal of this study is     to identify how to best use these methods, either alone or in combination.   "
19043|NCT03036306|"     The purpose of this study is to assess the safety and local tolerability of two different     concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a     day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the     absorption and elimination of profiles of this topically applied product will be determined     through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done     but are considered exploratory.   "
19044|NCT03036293|"     The purposes of this study are:        -  To further examine the efficacy and safety of Tenoten® in the treatment of anxiety in          patients with somatoform, stress-related and other neurotic disorders.        -  To compare the efficacy of two dosing regimens of Tenoten® (4 tablets daily vs.8 tablets          daily, both for 12 weeks) in the treatment of anxiety in patients with somatoform,          stress-related and other neurotic disorders.   "
19045|NCT03036280|"     The name of this trial is MissionAD2. This 24-month treatment, multicenter, double-blind,     placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's     Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early     stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat     (proposed international nonproprietary name [pINN]) (E2609).   "
19046|NCT03036267|"     Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured     adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn     may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A     brief shared decision-making intervention for use by primary care providers in Federally     Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve     asthma control in this high-risk patient group.   "
19047|NCT03036254|"     An urgent need exists to identify effective interventions to arrest or reverse dementia and     cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will     investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive     functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive     impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen     therapy effects on cognition in diabetes. The potential to preserve, or even enhance,     cognition in elderly at high risk of cognitive decline and dementia has major implications     for the affected individuals and their support systems that bear the social and financial     burdens of long-term caregiving.   "
19048|NCT03036241|"     The purpose of this study is to determine whether the use of drug-eluting balloons is     effective in the treatment of (re)stenosis in dialysis fistulae.   "
19049|NCT03036228|"     The primary objective of this study is to determine safety and tolerability of Karonudib for     the treatment of cancer.      Secondary objectives are to determine a recommended RP2D and schedule for further development     of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of     treatment efficacy. Overall survival will also be recorded.   "
19050|NCT03036215|"     The purpose of this pilot project is to determine the feasibility and acceptability of     proposed methods for a subsequent clinical trial of a tailored self-management program (PACT)     designed to decrease pain in participants with temporomandibular disorders (TMD). The PACT     program is a personalized program of exercise and behavioral changes implemented through a     web-based program supported by a health coach. For this feasibility and acceptability study,     80 adults with TMD pain will be randomized either to the PACT program or to traditional     self-care.   "
19051|NCT03036202|"     To determine the pharmacokinetics of epinephrine during cardiac arrest.   "
19052|NCT03036189|"     This is a group randomized trial of an intervention to improve chronic illness     self-management.   "
19276|NCT03033225|"     The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a     photodynamic therapy (PDT) to evaluate response of tumor.   "
19053|NCT03036176|"     Children with severe acute malnutrition (SAM) are at serious risks that compromise their     growth and development. Studies have shown the benefits of psychosocial intervention in     mitigating the negative consequences of SAM. However, such intervention studies have targeted     the critical period in child development and thus focused on children under three years of     age. Dietary rehabilitation is usually included as part of the intervention package.     Moreover, these young children in such studies customarily obtain more care than older ones     and have access to breast milk, more frequent interaction with mother and other caregivers in     the family. Therefore, effects of psychosocial interventions targeting such age groups may be     different for older children. Much is not known if children older than three years of benefit     from similar interventions, and if family-based psychomotor/psychosocial intervention can     benefit SAM children in low income contexts such as Ethiopia where access to balanced diet     remains hardly possible. In Ethiopia, one of the poorest countries in the world, many     children are admitted to hospital for treatment due to SAM. The nutritional rehabilitation     unit at hospitals provide dietary treatment to the SAM children who are also treated for     related illnesses and complications. Once discharged from hospital, however, the SAM children     return to the same poor home environments with inadequate care and unbalanced diets. The main     objective of this study was to evaluate the effect of play-based family-centered     psychomotor/psychosocial stimulation on linear growth, nutritional status and developmental     outcomes of under-six SAM children in the Jimma Zone, south west Ethiopia. This was done by     randomly assigning the SAM children admitted to Jimma University's Specialized Referral     Teaching Hospital into control and intervention groups. Both groups were receiving the     routine medical and dietary treatment services. The intervention group additionally received     play-based psychomotor/psychosocial stimulation. Caregivers, supported by periodic visits     made to their homes, continued the simulation. Measurements were taken after six months of     home follow-up. It was hypothesized that the intervention would significantly improve some of     the developmental skills of these children, and that the effect may be age-dependent.   "
19054|NCT03036163|"     Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending     dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after     single and multiple oral administration   "
19055|NCT03036150|"     The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and     cardiovascular mortality in patients with chronic kidney disease   "
19056|NCT03036137|"     Relating the electroencephalogram findings of patients with tinnitus before and after a     therapeutic modality is still scarce in the literature, especially with neuromodulatory     methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is     a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on     patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with     tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS     in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and     the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n =     18) will be recruited for comparative purposes of brain electrical activity with and without     tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct     current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed     before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale -     VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be     performed after 1 month of the end of treatment with tDCS.   "
19057|NCT03036124|"     The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of     worsening heart failure or cardiovascular death in patients with chronic heart failure with     reduced ejection fraction.   "
19058|NCT03036111|"     Trimebutine acts through smooth muscle relaxation. It is presumed that the topical     application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure     by relaxing the internal anal sphincter spasm.   "
19059|NCT03036098|"     The purpose of this study is to determine whether an investigational immunotherapy nivolumab     in combination with ipilimumab is more effective than standard of care chemotherapy in     treating patients with previously untreated inoperable or metastatic urothelial cancer.   "
19060|NCT03036085|"     The aims of the study are to compare the effectiveness and postoperative outcomes of     liposomal bupivacaine vs plain bupivacaine following video-assisted thoracoscopic surgery.     The investigators' hypothesis is that liposomal bupivacaine will decrease the postoperative     pain and will be associated with more favorable postoperative outcomes when compared to plain     bupivacaine following video-assisted thoracoscopic surgery.   "
19061|NCT03036072|"     This is an unblinded, single center, randomized study of infants with congenital heart     disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming     intervention or to the standard of care (strict normothermia).   "
19062|NCT03036059|"     The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation     sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6     rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is     Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana,     MDA has been undertaken since 2001. While the disease has been eliminated in many areas,     transmission has persisted in some implementation units that had experienced 15 or more     rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping     under insecticidal nets have significantly accelerated transmission interruption in some     settings of high transmission intensity. Thus, it is evident that new intervention strategies     could eliminate residual infection in areas of persistent transmission and speed up the LF     elimination process. This study therefore seeks to test the hypothesis that biannual     treatment of LF endemic communities will accelerate interruption of LF transmission.      Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The     interventions will be yearly or twice-yearly MDA delivered to entire endemic communities.     Allocation to study group will be by clusters identified using the prevalence of LF. Clusters     will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB;     (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary     outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys.     Entomological assessments will also be undertaken to evaluate the transmission intensity of     the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a     random subsample of participants, microfilaria prevalence will be assessed longitudinally. A     nested process evaluation, using semi-structured interviews, focus group discussions and a     stakeholder analysis, will investigate the community acceptability, feasibility and scale-up     of each delivery system.   "
19063|NCT03036046|"     Non-randomized, multi-centre, open label, uncontrolled, multiple dose, phase IIa study.      A total of 18 patients diagnosed with acute myeloid leukaemia (AML) scheduled for     chemotherapy and expected to be neutropenic (<500 Absolute neutrophil count (ANC)/µl) for >10     days will be treated. F901318 will be given in conjunction with fluconazole or posaconzaole     in order to assess safe treatment regimens for both combinations.   "
19064|NCT03036033|"     This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation     device in the treatment of patients who have reduced ability to open their hand due to     weakness after an acute stroke.   "
19105|NCT03035500|"     This clinical trial studies how well a long-term follow-up works in patients with prostate     cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical     questions, describe health-related quality of life and long-term complications related, and     facilitate future studies focusing on interventions to improve health status and     health-related quality of life in prostate cancer survivors.   "
19065|NCT03036020|"     The main aim of the NASPP study is to assess the efficacy and safety of the prehospital     diagnosis of stroke using the Norwegian stroke ambulance concept. NASPP aims to demonstrate     that anesthesiologists trained in pre-hospital critical care may perform acute stroke     diagnostics by clinical assessment and CT scan interpretation and integrating these skills in     the already existing organizational frame of the Norwegian prehospital EMS system.      NASPP will systematically explore the Norwegian model of prehospital acute stroke diagnostics     prior to the implementation of prehospital thrombolytic stroke treatment. NASSP will equip a     regular ambulance staffed with a specially trained anesthesiologist and a specialized nurse.     NASPP will perform the clinical part of the study in close co-operation with Østfold     Hospital, Fredrikstad.   "
19094|NCT03035643|"     This study is for participants who have been diagnosed with an acute aortic     dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/     intramural hematoma). In a healthy aorta (the vessel that supplies blood to most of the body)     the blood flows freely through the main lumen (a space inside the vessel where blood flows).     The participants involved in this study have a tear that has separated the inner layer of the     aorta wall and created a secondary channel (false lumen) in addition to the main channel     (true lumen). The blood is now flowing through both channels.      The purpose of this study is to investigate the feasibility and safety of the AMDS (stent).     The use of this device may allow healing of the false lumen (separated channel). If the AMDS     together with conventional surgery is effective, it is believed that this could lead to the     repair of the dissection (tear) in the treated aorta,   "
19066|NCT03036007|"     Background: Patients suffering residual disability after anterior decompression and fusion     (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or     neck-specific exercises (NSE). Currently, we lack data for the success of either approach.     There is also a knowledge-gap concerning the use of internet-based care for chronic neck     pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion     of patients with various degrees of incapacity following ACDF, warrants increased efforts to     investigate and improve cost-effective rehabilitation.      Objective: To investigate the effectiveness of a structured, internet-based NSE program,     versus PPA following ACDF surgery.      Methods: This is a prospective, randomised, experimental, longitudinal multicentre study,     that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI)     following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs     following attendance at routine clinical appointments, scheduled for 3-months post-surgery.     Patients are then randomised to one of two groups (70 patients/group), scheduled for a     3-month treatment of either internet-based NSE or PPA. Questionnaires on background data,     pain and discomfort, physical and mental capacity, satisfaction with care, and health and     workplace factors are completed, with physical measurements of neck-related function     performed by independent test leaders blinded to randomisation. Measurements are performed at     inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up.     Radiography will be completed at the 2-year follow-up. Preoperative data will be collected     from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and     sick leave will be requested from the relevant national registers.   "
19067|NCT03035994|"     Altered loading is a causative factor for the development of knee osteoarthritis following     anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an     effective intervention to manipulate altered mechanical loading about the knee. The purpose     of this study is to 1) determine if ACLR participants are able to acquire and retain various     loading patterns using real-time biofeedback, 2) determine the effect of altered loading on     lower extremity biomechanics during walking gait, and 3) determine the effect of altered     loading on biochemical markers of collagen turnover and inflammation during walking gait.   "
19068|NCT03035981|"     Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes,     due to rapid digestion of starch into glucose. The specific properties of starch within these     foods has been studied for the purpose of slowing their digestion rate and improving related     physiological outcomes, such as gastric emptying rate. The current study investigated the     relationship among starch digestion, gastric emptying rate and satiety in white and brown     rice.   "
19069|NCT03035968|"     Stroke is the major cause for permanent disability in adults. It is still unclear, which     physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely     used approaches in stroke rehabilitation within the western world, although several studies     have failed to demonstrate superiority and showed partially even inferiority compared to     other physiotherapy approaches. The Vojta therapy is based on a completely different approach     - the reflex locomotion. However to date no study has been performed for stroke. We designed     a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients     with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to     investigate improvement of postural control due to Vojta therapy in early rehabilitation of     stroke patients, which is a very new approach in stroke-rehabilitation.   "
19070|NCT03035955|"     The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum     counts and disease condition via a split face design in approximately twenty patients with     mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with     azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in     lesion count and redness.   "
19071|NCT03035942|"     The aim of this study is to evaluate not only the occurrence of side effects, but the quality     of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with     administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of     fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg),     dexamethasone (8mg) or placebo.   "
19073|NCT03035916|"     This study evaluates the effect of transversus abdominis plane(TAP) block combined with     general anesthesia on perioperative stress response in patients undergoing radical     gastrectomy. One third of participants will receive TAP block combined with general     anesthesia, another one third of participants will receive epidural anesthesia combined with     general anesthesia, while the rest will receive only general anesthesia.   "
19074|NCT03035903|"     The goal of this clinical protocol is to perform a randomized crossover study to determine     the energy cost of holding the MedGem® device above a person's normal resting metabolic rate     (RMR) compared to not holding the MedGem® device.   "
19075|NCT03035890|"     This study includes the additional use of radiation therapy in combination immunotherapy in     order to determine whether the radiation may improve the response of non-small cell lung     cancer to immunotherapy and to monitor any side effects.   "
19076|NCT03035877|"     This study's purpose is to examine the effectiveness of a promising intervention for emerging     adults (EAs) with alcohol and other drug (AOD) abuse and justice involvement in achieving the     ultimate outcome of reduced criminal activity. The study will also examine that effect on     intermediate outcomes as follows: 1) reduced AOD use; 2) greater gainful activity (increased     educational success, employment and housing stability; decreased antisocial peer involvement     and relationship conflict); 3) and greater improvement in self-regulation (self-efficacy,     goal directedness and responsibility taking). The intervention to be tested is Multisystemic     Therapy-Emerging Adults (MST-EA). MST-EA is an adaptation of MST, a well-established,     effective intervention for antisocial behavior in adolescents.   "
19077|NCT03035864|"     The proposed phase II study is a single-centre, randomized, double masked, parallel arm,     vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF     eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who     underwent cataract and corneal refractive surgery, both known to damage the corneal sensory     nerve plexus.      After confirmation of inclusion and exclusion criteria all eligible patients will be     randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study     treatments administration with 4 weeks Follow-up.   "
19078|NCT03035851|"     The estimated annual cost of dementia in Canada is $15 billion, with a projected cumulative     economic burden of $800 billion by 2038. Effective prevention of dementia at a population     level will need to include lifestyle factors such as promoting higher levels of physical     activity. Physical inactivity is a modifiable risk factor for Alzheimer disease (AD) and     cognitive decline, but the mechanisms by which physical activity exerts its protective effect     on the brain remain unknown. Motivated by the need to develop strategies to prevent and treat     AD and related dementias (ADRD), the investigators' overall research goal is to discover why     the aging brain develops ADRD. To achieve this goal the investigators adopt a translational     physiology approach (i.e., study of physiology from molecule/cell to population) to     investigate how exercise improves cognitive performance, and the underlying mechanisms by     which exercise prevents and/or slows down age-related declines in brain health and cognition.     This approach allows the investigators to determine how physiological function is related to     ADRD, with important implications for health. The investigators' prior work demonstrated a     significant relationship between fitness, vascular regulation and cognition in older adults     free of overt disease. These findings have implications for vascular cognitive impairment and     ADRD, in which hypoperfusion and dysregulation of cerebral blood flow are thought to be     important pathophysiological factors. The investigators' central hypothesis is that regular     aerobic exercise mitigates age-related decreases in vascular function and cerebrovascular     reserve, which in turn benefits cognition. Work by the investigators and others has provided     the necessary data justifying a randomized controlled trial to evaluate the role of exercise     in the prevention of ADRD.      The investigators are well equipped to undertake this trial; the investigators have dedicated     institutional support and necessary expertise in vascular regulation, cognition, aging,     neuroimaging and genetics.      The overall objective of this proposal is to test an exercise intervention for secondary     prevention of ADRD in adults between 50 and 80 years old who are at increased risk for ADRD     (with memory impairment symptoms but without dementia). The rationale for this trial is the     urgent need for dementia prevention: an exercise intervention, which harnesses a     translational physiology framework, holds such promise. The investigators will conduct this     trial to determine the effects of aerobic exercise on the development of age-associated     cognitive decline and dementia. The exercise intervention is designed with input from Alberta     Health Services, the universal healthcare provider for Albertans, so that the intervention     can be readily adopted into clinical practice if this trial is successful. The trial will     address three specific aims.      SPECIFIC AIM 1: Determine the independent effect of exercise on cognitive performance in     previously inactive older adults at increased risk of ADRD. The investigators hypothesize     that participants randomized to our six-month aerobic exercise intervention will perform     better on cognitive tests, compared to control participants randomized to a stretching-toning     exercise group.      SPECIFIC AIM 2: Determine underlying biological mechanisms that influence cognitive     performance after exercise training. The investigators hypothesize that exercise improves     cognition due to changes at molecular/cellular (biomarkers), vascular (cerebral blood flow,     cerebrovascular reserve), anatomical and functional (neuroimaging), and behavioural (sleep     quality) levels. Further, the investigators hypothesize that ADRD-specific genetic risk     scores, reflective of targeted genetic variants, moderate exercise-related cognitive and     brain outcomes.      SPECIFIC AIM 3: Determine the extent to which changes in cognition, resting cerebral blood     flow and cerebrovascular reserve persist 12 months after participants complete a 6-month     exercise training intervention. The investigators hypothesize that the effects of improved     aerobic fitness will be maintained over time as a function of persistent lifestyle changes     and behavioural support programs. This trial will provide evidence needed to make clinical     recommendations for exercise programs in adults at risk for ADRD, with the goal of preventing     dementia. Given the investigators' extensive stakeholder input, this intervention will be     easily translated to other jurisdictions. This research into the mechanisms of effect for     exercise will identify patient subgroups most likely to benefit, surrogate outcome markers     for use in future trials to refine intervention dose/duration, and new therapeutic targets     for future interventions.   "
19095|NCT03035630|"     This is an open label, randomized phase II trial. Eligible subjects will be randomized in a     1:1 ratio and stratified for known prognostics variables to one of two first-line medication     treatment arms. Once disease progression has been documented, and following a required     inter-line washout period, subjects will receive either second-line medication treatment or     discontinue treatment, per discretion of treating investigator.   "
19079|NCT03035838|"     Traumatic brain (TBI) injury is the major cause of morbidity and mortality worldwide     especially in population under 40 years of age and has a significant socioeconomic impact.     TBI results from the head impacting with an object or from acceleration/deceleration forces     that produce vigorous movement of the brain within the skull, with the resultant mechanical     forces potentially damaging neurones and blood vessels and causing irreversible, primary     brain injury. Primary injury leads to activation of cellular and molecular responses which     lead to disruption of the blood-brain barrier causing the brain to swell. As the intracranial     space is not expandable (i.e. is fixed), this swelling leads to increase in intracranial     pressure (ICP) compromising blood supply to the rest of the brain leading to secondary brain     injury. As we are unable to reverse the primary injury, current protocols use supportive     measures to control the ICP and ensure optimal blood supply to the brain in an attempt to     minimize secondary injury. Our understanding of the factors involved in the initiation and     propagation of brain swelling in TBI is growing and the role of neuroinflammatory cytokines     in this process is increasingly recognized. In preclinical models of TBI, a specific     inflammatory cytokine termed substance P (SP) is found to be associated with blood-brain     barrier disruption and development of brain oedema in the immediate phase following injury.     The aim of this study is to examine the role of SP in the genesis of cerebral oedema and     elevation of ICP and thus secondary injury following human TBI. This would be achieved by     blocking SP function with a SP receptor antagonist Fosaprepitant (IVEMEND®, Merck) in the     first 24 hours following TBI and then continuously measuring ICP and assessing the evolvement     of TBI using magnetic resonance imaging.   "
19080|NCT03035825|"     This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in     head and neck cancer patients with xerostomia.   "
19081|NCT03035812|"     Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be     useful. This therapeutic intervention has been said to increase extracellular volume leading     to rising blood pressure. No prospective data has been published in clinical routine. Here,     investigators propose to follow patients in which an oral alkalinization is indicated: blood     pressure, body weight, and a clinical evaluation of the extracellular compartment will be     performed at the beginning and during the follow-up of participants. The principal criterion     of evaluation will be the variation in the extracellular compartment.   "
19082|NCT03035799|"     This pilot study proposes to gain a better understanding of the health benefits of the     popular paleo-diet in patients with irritable bowel syndrome (IBS) and explore underlying     mechanisms of benefit.   "
19083|NCT03035786|"     This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic     help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive     Care Unit, SICU).      The anaesthetists are doctors trained in advance airway management. Patients in the hospital     may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion     of breathing tube) for various reasons. The on call SICU anaesthetists responds to the airway     code by attending the patient in need and managing the patient at their own discretion.      Airway management will depend on the anaesthetist's knowledge, skills and experience. it will     also depend on the available airway equipment.      We plan to evaluate airway codes for a 24 month period. Parameters include: type of incident;     patient factors (including airway assessment); type of equipment used; anaesthetic drugs     used; airway management chosen by the attending anaesthetist; and, airway complications.   "
19084|NCT03035773|"     OBJECTIVE: The purpose of this study is to identify an SCP process that is patient-centered,     effective in promoting appropriate survivorship care and can be successfully implemented for     patients with different types of cancer who are being treated in a broad range of clinical     settings. There is a need for research related to SCP that prioritizes outcomes that are most     highly valued by patients, caregivers and clinical stakeholders.   "
19085|NCT03035760|"     This Phase I study is an open label multiple ascending dose evaluation of the safety and PK     of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant     women aged 18-45 followed by a single dose cross over trial evaluating the safety and     pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or     following a high fat meal. The study duration will be approximately 12 months with each     subject participation lasting approximately 6 weeks. In the multiple ascending dose     evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of     eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and     monitored for 7 days from the time of the first dose for predefined adverse events. If there     are no predefined safety events, a second sentinel subject will be enrolled and followed for     a total of 7 days. If there are no predefined safety signals identified for either of these     two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight     subjects have completed the 10 day follow up period, an electronic safety review of the     electronic data will be performed. If none of the predefined safety events have occurred DMID     will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and     will be monitored for a total of 7 days each for predefined adverse events prior to enrolling     the remaining subjects in the group. After the 10 day follow up period has been completed for     group 2, an electronic safety review will be completed and if no predefined events have     occurred two sequential subjects (one at a time with 7 days between each subject) will be     enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be     monitored for a total of 7 days each for predefined safety events prior to enrolling the     remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled     into the single dose cross over group where half of the subjects will initially receive a     single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will     receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then     cross over to receive a single dose following a high fat breakfast or fasting period (water     is permitted). All subjects will have received a dose of oxfendazole following both a fasting     period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole     administered daily for five days; and 2) To assess the safety of oxfendazole administered as     a single dose with or without food.   "
19093|NCT03035656|"     The following is a double blinded, randomized controlled clinical trial to test the     hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single     intra-operative epidural injection of Ropivaciane® will result in decreased postoperative     pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2)     Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if     there are differences in pain management between MIS and open surgical procedures. The     proposed study will add novel information to current knowledge by 1) exploring of the effects     of intra-operative single epidural injection analgesic on patients receiving MIS compared to     open surgery, and 2) investigate potential immediate and short-term functional improvements     gained from intra-operative single injection of Ropivaciane®.   "
19109|NCT03035448|"     The goal of this research study is to learn about advanced cancer patients' preferences about     how psychology services are introduced.   "
19155|NCT03034018|"     The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri-     and postmenopausal women who are experiencing sleep difficulties related to nighttime hot     flashes.   "
19529|NCT03030196|"     To determine the significance of systemic RANKL inhibition for male reproduction, conducting     a clinical controlled randomized double blinded intervention study on infertile men, to     investigating whether Denosumab (Prolia) can increase semen quality and to investigate what     subgroup of infertile men that might benefit from treatment.   "
19096|NCT03035617|"     Early post-operative pain and discomfort after laparoscopic repair remains a concern for     patients requiring hospital stay and parenteral narcotic analgesics . This quite often proves     to be a hindrance in early ambulation, enhances patient discomfort and prevents early     discharge from hospital.      Local anesthetics infiltration at wound site after various procedures is known to be     effective in reducing immediate post-operative pain , . In case of laparoscopic ventral     hernia repair, delivering local anesthetic at site of mesh application can be achieved by     soaking the mesh in local anesthetic solution before application. To date there is no     evidence regarding impact of soaking mesh in bupivacaine solution before application in case     of laparoscopic ventral hernia repair.      OBJECTIVE:      Primary Objective:      To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to normal     saline solution on post-operative pain after laparoscopic ventral hernia repair.      Secondary Objective:      To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to saline     solution on length of hospital stay after laparoscopic ventral hernia repair.      Study Sample:      Patients with uncomplicated ventral abdominal wall hernia presenting at general surgery     clinics of AKUH Karachi who are planned to undergo laparoscopic repair and meet eligibility     criteria of inclusion into trial.      SETTINGS:      Study will be conducted in General Surgery Section of Aga Khan University Hospital, Karachi.      Patients will be evaluated in clinic at the time of presentation regarding eligibility to     participate in study. Written informed consent will be taken in clinic. A copy of the consent     form will be handed over to the patient. Clinical Trial Unit will be informed of the     scheduled date and time of the operation. Allocation will be done by the staff at clinical     trial unit which will be kept undisclosed to the investigators, patients and outcome     assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form     according to treatment arm allocation. After the operation first assessment of pain will be     done six hours post-operatively using VAS. Second assessment will be done at twenty four     hours from end of operation. This assessment will be done directly if patient is admitted in     the hospital or will be done on telephone if patient is discharged home.      FOLLOW UP:      Pain assessment will be done using visual analogue scale (VAS). This is validated score to     measure level of pain. It ranges from zero to ten. Score of 0 means no pain and score of ten     means worst pain one can ever have. Score will be assessed at 6 and 24 hours from procedure.   "
19097|NCT03035604|"     The goal of this research study is to learn about ways to check for malnutrition (loss of     weight/appetite that may result in health problems) that is due to cancer or cancer     treatment.   "
19098|NCT03035591|"     This is a first-in-man study to assess the safety and tolerability and to characterise the     pharmacokinetics of ODM-207.   "
19099|NCT03035578|"     This research aims to study what the baby's body does with morphine and how morphine works in     the baby's body. One hundred newborn babies will be enrolled in this study. With a better     understanding of the drug doctors and nurses will have more information and better administer     the drug in case of pain, stress or discomfort.   "
19100|NCT03035565|"     Cognitive Intervention to Improve Memory in Heart Failure patients   "
19101|NCT03035552|"     The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS)     using contingent positive reinforcement with mother's voice can improve the feeding outcomes     of infants with congenital heart defect (CHD) at high risk for oral motor problems.   "
19102|NCT03035539|"     The purpose of this study is to investigate whether a rehabilitation programme can improve     the quality of life and reduce morbidity in patients with atrial fibrillation.      In addition, the study will map the economic costs and benefits of such a rehabilitation     programme.   "
19103|NCT03035526|"     In this study, our aim is to show the relation between sex hormones and PAT and to confirm     whether PAT is associated with coronary artery calcification (CAC) in different testosterone     levels in the males.   "
19104|NCT03035513|"     Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic     encephalopathy. Even if the correlation between the severity of the epilepsy and the     cognitive consequences is well established, the mechanisms involved in epileptic cognitive     degradation are complex and poorly understood. In CSWS, there are many arguments for the     implication of cortical and subcortical cerebral structures. Among them the thalamus seems to     play a crucial role. In fact it is strongly implicated in the sleep and this function is     determining for learning. Moreover, it is part of the propagation pathway of generalized     forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for     CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but     most of the time conventional MRI is normal. Despite few literature on CSWS, some studies     reported abnormal functional connectivity especially in the thalamus.      The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI)     and tractography will be useful in CSWS to confirm the implication of a     cortico-thalamo-cortical network showing an abnormal structural connectivity. The     investigators will try to determinate if a particular thalamic nucleus is concerned and     demonstrate a link between the disease severity (duration and cognitive consequences) and the     importance of structural abnormalities.      Using resting state functional MRI (fMRI), the investigators will also try to investigate the     default mode network. Its implication was also suggested in the literature.   "
19106|NCT03035487|"     The investigational protocol describes a small case series designed to compare three imaging     modalities for use in visualizing prostate cancer.      The three modalities to be tested are: transrectal micro-ultrasound , and conventional     resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the     multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI     (mpMRI).      These modalities will be used for guiding systematic (standard, random, extended sextant)     plus image-guided targeted prostate biopsies among men with known cancer and an indication     for prostate biopsy.      In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the     radiology report used for targeting.   "
19107|NCT03035474|"     CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the     effect of 2 quality improvement (QI) initiatives compared with usual care on heart failure     (HF) outcomes and HF quality of care metrics at 1 year after discharge for participants     hospitalized with acute HF and reduced ejection fraction (EF). The interventions will include     both a health-system engagement group (direct) and a participants engagement group (digital).   "
19108|NCT03035461|"     Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly     population of the industrialized world. AMD is a progressive degenerative disease affecting     the central area of the retina, responsible for distinct vision. Vision loss arises from     aberrant new vessel growth which causes the accumulation of blood or fluid within the     retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are     exudative, or neovascular or wet, and non-exudative, or dry.      Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic     process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat     wet-AMD.      After diagnosis and explanations of the practionner, the patients and their close relatives     have still frequently many questions about the intravitreal injections, the prognosis, the     risk of visual impairment, etc. Few teams have studied the modalities of diagnosis     announcement and the understanding of the patients on the disease course.      The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as     well as the understanding of the possibilities of treatment and the clinical surveillance.   "
19110|NCT03035435|"     In the last years, a lot of surgical fast track programs (SFTP) have been created and     developed. This is due to the steady growing number of interventions on knee and hip; after     the surgical treatment, a period of physical rehabilitation (PR) is established to be useful     and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM),     independence, the reduction of pain and disability are the aims of PR. With the SFTP and a     specific rehabilitation program named fast track rehabilitation (FTR) these times can be     reduced. First of all because the length of stay (LOS) it's also caused by organizational     problems of the hospitals, not only for the factors related to the patient. It's already been     demonstrated that an early mobilization decreases the risk of thromboembolic complications     and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces     the lost of residual abilities. Moreover a PR program studied for fast track patient will     reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are     always a problem for all the countries. The aim of this study is therefore to propose a fast     track rehabilitation program based on an 8 days program for hip and knee arthroplasty being     operated with an SFTP.   "
19111|NCT03035422|"     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option     with a significant chance of healing in acute myeloid leukemia (AML) or refractory multiple     relapses after chemotherapy. However, all patients with an indication of allo-HSC can not     benefit because of two limitations: the toxicity of the treatment and graft shortage     available.   "
19112|NCT03035409|"     The goal of this clinical research study is to learn if anamorelin can help to decrease     cancer-related fatigue in patients with advanced cancer.      The safety of this drug in combination with physical activity will also be studied.   "
19113|NCT03035383|"     Thyroidectomy for large thyroid tumor poses a problem of cosmetics, especially in terms of     wide post-operative scar and prominent neck wrinkles. In this manuscript, we performed     purse-string suture for the first time for the closure of skin defect after thyroidectomy of     large thyroid tumors which resulted in better cosmetics as compared to the conventional     suturing method.   "
19114|NCT03035370|"     The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and     immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the     cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or     50 mcg PT protein compared to Viaskin placebo.      Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be     assessed throughout the 10-week study and its immunogenicity will be assessed at regular     intervals with collection of blood samples for immunological analyses.      Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will     receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal     recall of their immunity against pertussis.   "
19115|NCT03035357|"     The goal of this clinical research study is to learn about biomarker changes in patients who     have primary prostate cancer after receiving Darzalex (daratumumab) and then have a     prostatectomy (the surgical removal of the prostate) as part of their standard care.     Biomarkers are found in the blood/tissue and may be related to your reaction to the study     drug.   "
19116|NCT03035344|"     Study of the intermediate metabolism in children diagnosed with ALL compared to healthy     matched controls.   "
19117|NCT03035331|"     This phase I/II trial studies the best dose and side effects of dendritic cell therapy,     cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such     as dendritic cell therapy made from a person's tumor cells and white blood cells may help the     body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells     by freezing them. Monoclonal antibodies, such as pembrolizumab, may interfere with the     ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and     pembrolizumab may work better at treating non-Hodgkin lymphoma.   "
19119|NCT03035292|"     Sensitivity and specificity of current screening methods for congenital cataracts in neonates     is poor. This results in delayed diagnosis and management which can decrease the visual     prognosis following cataract surgery. It also results in many false positives with resultant     unnecessary healthcare costs in specialist paediatric ophthalmology services. The     investigator has developed a new digital technique to improve the accuracy of screening for     congenital cataract and this study will compare this new test with the current test     performed.   "
19120|NCT03035279|"     This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer     (CRC), and consists of Part A (dose regimen finding), followed by Part B (dose expansion).     Part A (dose regimen finding) will involve dose escalation and possible dose interval     modification to define the maximum tolerated dose (MTD) and/or recommended Phase 2 dose     (RP2D) and schedule. Part B (dose expansion) will enroll additional participants who will be     treated with a study drug dose at or below the MTD determined in Part A.   "
19121|NCT03035266|"     The investigators will compare differences in quadriceps strength, leg girth, and functional     outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months     following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight     bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One     group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by     the standard protocol progression for the remainder of the treatment program. The other group     will receive standard post-operative rehabilitation without BFR for the duration of treatment     program.   "
19122|NCT03035253|"     The purpose of this study is to test the safety and efficacy of an experimental drug,     OMP-305B83, when given in combination with FOLFIRI. OMP-305B83 is a humanized bispecific     monoclonal antibody and was developed to target cancer stem cells. Based on preclinical     studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may     also impair the productive growth of new blood vessels, which tumors need to grow and spread.      The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the     Sponsor.   "
19123|NCT03035240|"     The purpose of this prospective, randomized, controlled three-year study is to compare the     effect of a year-long financial education program versus usual care on health outcomes in     single mother low income households.   "
19124|NCT03035227|"     The purpose of this study is to test if catheter ablation is better than medication therapy     at treating arrhythmias originating from the upper and/or lower chambers of the heart in     order to allow the heart to beat properly.   "
19125|NCT03035214|"     Most preterm babies require supplemental oxygen for a variable period of time, up to several     weeks or months after birth. The aim of oxygen therapy is to achieve adequate oxygen supply     to the tissues without causing oxygen toxicity and oxidative stress. The current routine     monitoring relies on oxygen saturation by pulse oximetry without identifying the underlying     pathology, as lung parenchyma and pulmonary vascular disease can be contributed in     pathophysiology at variable degrees.      Steroids usage for prevention of Bronchopulmonary dysplasia also has been shown to have     adverse neurodevelopmental outcome. Available data are conflicting and inconclusive;     clinicians must use their own clinical judgment to balance the adverse effects of     Bronchopulmonary dysplasia with the potential adverse effects of treatments for each     individual patient. Very low birth weight infants who remain on mechanical ventilation after     1 to 2 weeks of age are at very high risk of developing Bronchopulmonary dysplasia.      When considering corticosteroid therapy for such an infant, clinicians might conclude that     the risks of a short course of glucocorticoid therapy to prevent Bronchopulmonary dysplasia     are warranted.   "
19126|NCT03035201|"     The parent trial (COcoa Supplement and Multivitamin Outcomes Study, COSMOS; NCT02422745) is a     randomized clinical trial of cocoa extract supplement (containing a total of 600 mg/d     flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to     reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and     women aged 65 years and older. A cognitive ancillary study (COSMOS-Mind) is being conducted     among men and women, 65 years and older, who are enrolled in COSMOS and will examine whether     the cocoa extract supplement or the multivitamin supplement improves cognitive function and     reduces risk of cognitive impairment, including AD and other related types of dementia.   "
19127|NCT03035188|"     In this study patients with resectable basal cell carcinoma (BCC) who usually undergo surgery     without prior anticancer treatment will be treated with antitumor medication. But since BCC     is mainly localized in clearly visible regions of the body, as e.g. the face, there is also a     need to reduce scars as a consequence of surgery which will be accomplished by neoadjuvant     therapy.      The used medication - vismodegib - displays controllable adverse events and shows a good     efficacy for reduction of BCC lesions. It is expected that the neoadjuvant setting will lead     to minor surgical intervention thus minimising surgical risks and scars for the patients.   "
19128|NCT03035175|"     This study examines the effectiveness of utilizing video laryngoscopy to give real-time     guidance during neonatal intubations to improve residents' success at performing intubations.   "
19129|NCT03035162|"     The aim of the present study is to evaluate the possible effect of using dual-tDCS combined     with conventional physical therapy on lower limb function in stroke patients.   "
19130|NCT03035149|"     Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the     effects of weight loss on dyspnea are not completely understood. The objectives of this study     were to examine the relationships between exercise parameters and dyspnea in obesity and     assess the effects of weight loss.      The investigators compared pulmonary function, exercise performance and dyspnea in 34     patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched     controls. The study also assessed within-group changes in physiology and symptoms in a subset     of patients following participation in a weight management program.      Because obesity is a heterogeneous condition, with variable genetic associations,     co-morbidities and distributions of adipose tissue, the study focused on patients with     abdominal obesity who met diagnostic criteria for metabolic syndrome.   "
19131|NCT03035136|"     Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.   "
27408|NCT02926989|"     The main objective of the trial is to evaluate the risk of hypokalemia following     administration of a isotonic solution compared to a hypotonic solution in acutely ill     hospitalised children, who need intravenous fluid therapy.   "
19132|NCT03035123|"     The EduStra-HF study will examine the impact of an intensive therapeutic education on     patients discharged from hospital after an episode of acute heart failure (HF).      Patients will be randomized into two groups: one will receive usual care monitoring and one     will receive a specific educational monitoring programme for 1 year.      All patients will meet with a specialized therapeutic education nurse before discharge.      The effect of the intensive education on HF rehospitalization and quality of life will be     examined.   "
19133|NCT03035110|"     The current research is being undertaken as part of a professional doctorate in clinical     psychology, which aims to evaluate the feasibility of a group programme to address self-harm     within 23 days, to provide evidence for a controlled trial. The intervention will include     four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy.     Specifically the aims are to determine 1) means and a standard deviation for two pre and post     treatment outcome measures in order to estimate sample size for the main study, 2) the need     for an inpatient intervention for self-harm measured by number of participants eligible and     accepting of the treatment, 3) retention of participants for 4 groups given the predicted     short stays of patients on wards, and 4) the acceptability of the research process for this     client group through feedback.   "
19134|NCT03035097|"     The purpose of this research study is to establish a research database and biorepository for     patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or     Operation Enduring Freedom (OEF). This study will also include civilian contractors who     worked as part of these military operations in Iraq or Afghanistan. The biorepository would     store blood samples obtained from these patients during a clinic visit. The research database     would store prospectively and retrospectively collected clinical and exposure data that would     enable us to comprehensively characterize each case.   "
19135|NCT03035084|"     Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3     level and therefore have proposed that D3 would be preferable in term of raising total     25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in     25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being     specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in     25(OH)D2 level.      The investigators plan to conduct a double-blind placebo-controlled trial to examine the     effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve   "
19140|NCT03035019|"     Stress and anxiety can worsen quality of life in patients seen in primary care practices.     This project is set in UPMC primary care practices (CMI) to evaluate how the availability of     a virtual stress management program can help patients reduce stress and anxiety and improve     their quality of life. The project will analyze the efficacy of the virtual stress management     program at these practices so that it can then be utilized effectively in other medical     settings where it can be offered as a part of clinical care to reduce stress and anxiety and     improve the quality of life of medical patients who could benefit from a reduction in stress.     This research is being piloted at these sites in the hopes of publishing results that show     that it can be implemented in other practices throughout the country.   "
19141|NCT03035006|"     This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in     hepatocellular carcinoma with portal vein tumor thrombosis.   "
19142|NCT03034993|"     The purpose of this study is to determine if an automated text message intervention is     beneficial for homeless patients in reducing their hospital visits, increasing their primary     care appointments, and help them increase medication adherence.   "
19143|NCT03034980|"     Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the     coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are     often treated with percutaneous coronary intervention (PCI) or coronary artery bypass     grafting (CABG). Following hospitalisation, the patients are offered to attend a classical     rehabilitation program with moderate exercise intensity. Current exercise program for cardiac     rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve     the exercise capacity and risk profile even more if the exercise program includes more     vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG)     and takes 12 weeks to complete. Patients with heart failure and valvular disease are     excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are     determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the     aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training     load during rehabilitation.      The research goal is to investigate the influence of training intensity on the exercise     capacity and risk profile of CAD patients.   "
19167|NCT03034798|"     The purpose of the study is to determine the effects of insulin suspension at start of     exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for this     project. The first will be a familiarization session that requires completed informed     consent, anthropometric measurements (height, weight, body fat percentage), questionnaires,     and a test of maximal aerobic fitness. The remaining 2 sessions will be steady-state aerobic     exercise as well as circuit exercise.   "
19336|NCT03032445|"     Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are     eligible, based on inclusion criteria, to participate in this research study that is seeking     to determine whether supplementation of beer (alcohol) immediately following a long distance     ultramarathon race can positively impact exercise-associated hyponatremia [EAH].   "
19145|NCT03034954|"     As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study     will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of     electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects     of TES on working memory, learning, and memory, will be evaluated in a group of healthy older     adults.   "
19146|NCT03034941|"     The aim of this study was to evaluate the impact of short-term weight reduction achieved with     12-week intervention with metformin alone or in combination with liraglutide on oocyte     maturity and embryo quality in infertile obese PCOS population.   "
19147|NCT03034122|"     The aim of the study is to establish if caffeine consumption is associated with the evolution     of the disease in premanifest HD.   "
19148|NCT03034109|"     The purpose of this study is to test the effects of tDCS (Transcranial Direct Current     Stimulation) on stroke patients with working memory problems.   "
19149|NCT03034096|"     This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with     total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane,     or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.   "
19150|NCT03034083|"     The purpose of this study is to determine whether the healthy marriage and relationship     education program Elevate: Taking Your Relationship to the Next Level results in improved     couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect     potential.   "
19151|NCT03034070|"     This study will assess and compare the diagnostic performances and image quality of two WB 3D     T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :     the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its     acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,     reducing the exam's acquisition time, patient discomfort and increasing machine availability.   "
19152|NCT03034057|"     A one-year evaluation of Sayana Press self injection in women of reproductive age in the     United Kingdom (UK).   "
19153|NCT03034044|"     This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe     in the setting of routine practice. The primary objective is to detect medically significant     events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy     and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In this     open-label, non-comparative, observational, non-interventional, retrospective and     multi-center study, post-marketing surveillance data will be collected retrospectively for up     to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe     injected into patients who have been administered the Xyntha Solofuse prefilled syringe.      As specified in the product approval issued by the Ministry of Food and Drug Safety, the     study will be conducted for 4 years from the approval date. At least 600 study subjects will     be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number     of study subjects, the number of cases will be adjusted considering the actual number of     enrolled subjects after the study start day.   "
19154|NCT03034031|"     This project will combine the data collected from structural and functional MRI scans and     neuropsychology performance post-TBI in children. Patients will be followed for a year, in     order to examine the brain and cognitive recovery post head injury.   "
19156|NCT03034005|"     This study aims to assess the effect of inhaled corticosteroids (ICS) on airway smooth muscle     (ASM) Na+, K+ pumps in patients with asthma.We wish to investigate differences in Na+, K+     pump content in healthy versus asthmatic patients, whether a reduction in airway     hyper-responsiveness observed in asthmatic patients treated with ICS is attributable to an     increase in Na+, K+ pump content in ASM cells and compare this in patients with     non-eosinophilic asthma versus eosinophilic asthma.   "
19157|NCT03033992|"     This feasibility trial studies how well the Optune device works in treating younger patients     with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. The     TTFields generated by Optune device may inhibit the growth of tumor.   "
19158|NCT03033979|"     The investigators conclude that use of the LMA ProSealTM for prolonged procedures is     feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided     basic guidelines are followed.   "
19176|NCT03034681|"     This pilot pre-post quasi-experimental study evaluates for the first time the effectiveness     of Vojta Therapy in treating lumbosciatic and compares it with the transcutaneous electrical     nerve stimulation (TENS) procedure. Patients who agree will be distributed alternately in     order of arrival to a Physiotherapy Unit, in such a way that half of the sample will be     treated using TENS and the other half with Vojta.   "
19202|NCT03034343|"     The aim of this study is to assess and compare a mindfulness low-intensity (4 weeks)     psychological intervention for the treatment of depression in Primary Care between different     groups: a mindfulness intervention applied face to face in group format, a control group that     will receive treatment as usual (TAU) consisting of medical treatment and the same     mindfulness intervention applied by Information and Communication Technologies (ICTs). The     principal hypothesis is that face to face intervention will be more effective than TAU   "
27409|NCT02926976|"     The Optimal Treatment for Treatment-resistant Schizophrenia   "
19160|NCT03034889|"     The infantile brain has to pass essential, mayor steps in the first 36 months of life. During     that period of development it is particularly vulnerable to toxic, exogenic influences. This     study wants to review the long-term effects of children who were exposed to anesthesia in the     first three years of their life. Therefore the investigators will examine children at age of     4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children     who did not have any exposure to anesthesia. The investigators plan on measuring the     intelligence quotient using standardized tests which will be performed by a trained     psychologist. In addition there will be a questionnaire concerning behavioral characteristics     and educational development which is filled by the parents. The exposed children will be     recruited from our preexisting database, the control group will be recruited from     practitioners and the pediatric walk-in-clinic.   "
19161|NCT03034876|"     Acute Kidney Injury is common in critically ill children and is associated with high     morbidity and mortality in pediatric intensive care unit. The serum creatinine is still a     gold standard test for diagnosis of AKI, but it rises after 1 to 3 days of injury . However,     Neutrophil Gelatinase-Associated Lipocalcin (NGAL) is an emerging biomarker in identifying     AKI at an early stages, which may in future help us in promptly instituting reno-protective     interventions like avoidance of nephrotoxic exposure and contrast agents, maintenance of     euvolemia and perfusion pressure which will not only preventing kidney from further failing,     decrease the use of very expensive and complicated renal supportive therapy like continuous     renal replacement therapy (CRRT) as well as in decreasing morbidity and mortality related to     AKI.   "
19162|NCT03034863|"     The management of suicide risk is a pressing national public health issue especially among     Veterans, and there exist no guidelines of how best to involve family members in this effort.     This proposal will integrate family and couples communication skills training with suicide     safety planning. The goal is for the sharing of Veteran suicide safety plans with family     members and the construction of a parallel family member safety plan, in efforts to mobilize     and support family involvement.   "
19163|NCT03034850|"     Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy     (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological     malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on     platelet and on coagulation level. The potential hemostatic interference in CRS and HIPEC is     phase dependent. This study demonstrates the combined use of ROTEM (rotational     thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test)     assays during CRS and HIPEC with a follow-up of 7 days postoperative.   "
19164|NCT03034837|"     Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high     occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure     caries in this tooth is therefore of great importance for the preservation of a healthy     dentition in one's life long time.      It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly     effective method to prevent pit and fissure caries. It has also been shown that the     performance of sealing pits and fissures by glass ionomer materia l (the high viscosity,     classification type 2 GIC material) using finger press method used in the atraumatic     restoration method is as significant as that of using the traditional resin sealant material     and technique.      The purpose of this study is to evaluate the long-term cost-effectiveness performance of the     two sealing materials in the prevention of pits and fissures caries in young permanent molars     of schoolchildren in a dental public health program to be held in primary schools. The     findings will provide valuable information for decision making on the election of proper     material and method for use in dental public program, especially for child population in the     rural or social-economically deprived areas.   "
19165|NCT03034824|"     The aim of our study is to determine the interleukin-1βeta (IL-1β), interleukin-8 (IL-8) and     tumor necrosis factor-αlfa (Tnf-α) levels in gingival crevicular fluid (GCF) and clinical     periodontal parameters following the treatment with     Erbium,Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) and diode lasers in adjunct to     scaling and root planing (SRP) in patients with generalized aggressive periodontitis (GAgP).     Twenty-six patients with GAgP (n=26) were enrolled in the study. The study was designed as a     split-mouth study. In each patient, three quadrants were randomly determined as     SRP-control, SRP+Er,Cr:YSGG and SRP+Diode laser. Clinical periodontal measurements were     recorded at the baseline and third month after the treatment. Cytokines levels in GCF were     determined by enzyme-linked immunosorbent assay (ELISA).   "
19168|NCT03034785|"     The morbidities associated with very low birth weight (VLBW) infants constitute a major     health problem and a significant emotional and financial burden for families and our nation.     The key to reducing this burden is early diagnosis. This research will be the first step     towards intervention for cerebral growth and long-term neurodevelopmental morbidities of VLBW     infants.      The proposed research is to design and fabricate a new technological innovation in wearable     soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the hand     (wrist and fingers) of toddlers. Building upon the investigators' ongoing work, they plan to     engineer stretchable electronics for safe, toddler-scaled flexi-mitts to measure planning and     force modulation. Additionally, the investigators plan to have the parent/guardian wear the     gloves so they can determine the relative contributions of the child and the adult to the     child's learning. In the same way that the adult assists learning to walk, they may assist in     learning during play. The force data may be analyzed in the same way as the child's data.      The investigators' new flexi-mitt technology has the potential to provide a new diagnostic     technology and the development of clinical assessment norms. With additional trials of the     technology in large numbers of young children, it may be possible for clinicians and day care     providers to eventually make measurements of planning and force modulation in play settings.   "
19169|NCT03034772|"     A previous pilot study demonstrated that commonly available glaucoma drops     (dorzolamide-timolol) might decrease the amount of chronic swelling in patient with wet     age-related macular degeneration who have been receiving anti-vascular endothelial growth     factor (VEGF) injections. This will be a larger study where subjects are randomly assigned to     receive the glaucoma drops or a placebo (artificial tears) in order to confirm whether this     previous finding is valid. Subjects will continue to receive the normally scheduled anti-VEGF     injections at regular intervals as done prior to enrollment. The only addition to the regimen     will be the daily use of eye drops (dorzolamide-timolol or artificial tears) twice daily for     the duration of the study. At the end of the study, the swelling in the retina will be     compared to the amount before starting the drops to see if there is any difference between     the group using dorzolamide-timolol versus artificial tears.   "
19170|NCT03034759|"     We aim to test the efficacy of a new method for determining individual insulin sensitivity     (IS) based on sensor-augmented-insulin pump (SAP) data in order to customize the insulin to     carbohydrate ratio (CR) in adolescents with type 1 diabetes (T1D).      To date, the individual insulin sensitivity (IS) could only be investigated by intensive and     invasive research techniques that are not feasible to perform in an outpatient setting for     pediatric patients with diabetes.      Recently published studies have demonstrated the efficacy of an algorithm to calculate the     patient specific insulin sensitivity to customize the CR for adult patients with T1D. The     algorithm has been validated in adult patients, however not yet investigated in the pediatric     population with T1D.      The aims of our study are:        1. to customize the CR of pediatric subjects with T1D using the individualized insulin          sensitivity index (ISind) to improve post-prandial blood glucose control after a          standard meal.        2. to test, under free living condition (at home), the efficacy of the customized CR in          improving post-prandial glycemic control for pediatric subjects with T1D.      This approach would have at least two potential benefits for pediatric patients with T1D:        1. To provide a non-invasive tool for individualizing their home insulin therapy;        2. To offer a reliable instrument for adjusting the meal bolus of the current hybrid closed          loop (HCL) systems to account for the inter-subject variability in insulin action.   "
19171|NCT03034746|"     Emerging literature suggests that vascular factors might be involved in the pathogenesis of     Alzheimer's disease (AD). Other recent studies demonstrate the positive effects of physical     activity on cognitive and behavioral disturbances of patients with AD. Therefore, it has been     postulated that exercise enchantment in cerebral circulation is the physiological mechanism     that link physical exercise and reduction of AD symptoms. Consequently, a program of physical     activity could be considered one approach to counteract dementia by improving cerebrovascular     health.      However at this moment, it is not clear if the progressive brain vascular dysfunction and     hypoperfusion, associated with the β-amyloid deposition, might be reversed or stabilized by     an exercise intervention.      The aim of this study is to assess, in patients with AD, the influence of physical exercise,     compared to cognitive stimulation, on:        -  Cognitive function;        -  Independence in daily living and behavioral symptoms;        -  Vascular function Finally, to investigate the physiological processes on the basis of          the motor parameters' changes, the performances of the patients will be compared with          the performances of healthy young and old subjects.      MAIN OBJECTIVE: Investigate, in patients with Mild Cognitive Impairment (MCI) and AD, the     effects of a physical activity program, or cognitive stimulation on global cognitive     function.      SECONDARY OBJECTIVES: Investigate the effects of the two treatments on:        -  cognitive and motor performances,        -  independence in activities of daily living,        -  behavioral symptoms,        -  peripheral vascular function.   "
19172|NCT03034733|"     The purpose of this study is to examine, if a single-dose of dexamethasone given during the     operation, alleviates pain after knee replacement surgery.   "
19173|NCT03034720|"     SPECIFIC AIMS      While post-concussive symptoms following sports-related concussion are typically transient     and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who     sustain concussion experience significant morbidity that can persist well beyond the normal     disease course.Furthermore, post-concussive symptoms commonly co-occur with affective     symptoms including depression and anxiety which when present can prolong recovery from     primary post-concussive symptoms. Together, persistent physical and psychological symptoms     confer protracted functional impairment and create a significant burden for affected youth,     their family, and school. Currently, there are no evidence-based guidelines to inform     treatment of persistent post-concussive symptoms in youth and adolescents.      In response to the dearth of evidence-based treatment approaches for youth with persistent     post-concussive symptoms, the investigators developed a novel collaborative care treatment     model that simultaneously targets post-concussive symptoms and co-occurring depression and     anxiety. Athletes and their family members receive patient navigator care management services     that bridge post-injury care across acute care, specialist and primary care health service     delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain     symptomatic after initial treatment efforts receive stepped-up care that may include     psychopharmacologic consultation. The Investigators have demonstrated feasibility of the     intervention model through a pilot randomized-control trial of 49 adolescents with persistent     post-concussive symptoms recruited from a regional children's hospital. Participants assigned     to the intervention condition demonstrated significant and clinically-meaningful reductions     in post-concussive and depressive symptoms as well as health-related quality of life as     compared to adolescents in the usual care arm of the trial.      The proposed study will expand upon the pilot trial in order to further develop, implement,     and test the impact of an innovative collaborative care approach tailored to the needs of a     patient population who currently have no evidence-based options. The investigators propose a     broad reach intervention strategy that is designed to be readily implemented in acute,     specialty and primary care medical settings, as well as over the telephone. The investigators     will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18,     suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related     injury. Athletes will be randomized to collaborative care (intervention) or post-sports     injury care as usual (control group) conditions. The study is designed with the following     aims:      Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in     reducing post-concussive and co-occurring psychological symptoms in youth with persistent     post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative     care intervention will demonstrate clinically and statistically significant reductions in     post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month     study, compared to usual care control group athletes Aim 2. To examine the effectiveness of     the intervention in improving function and health-related quality of life amongst youth with     persistent symptoms after sports-related concussion H2: Adolescents who receive a     collaborative care intervention will exhibit a clinically meaningful improvement in function     and health-related quality life Exploratory Aim 3. To explore differences in school     performance between groups H3: Adolescents who receive the collaborative care intervention     will receive individualized treatment and community resource linkages which will improve     their school performance as compared to adolescents receiving treatment as usual      IMPACT: By broadly targeting the constellation of post-concussive physical and psychological     symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral     health providers, the collaborative care health services intervention could accelerate the     rate of recovery from persistent post-concussive symptoms and attenuate the degree and     duration of disability during adolescence, a critical period for healthy development.     Validation of this treatment through a scaled up clinical trial will serve as a foundation     for broader dissemination of this collaborative care treatment model. The multidisciplinary     sports concussion research team will simultaneously work nationally and internationally to     ensure study results are expediently translated into effective policy for youth athletes     suffering from enduring symptoms and functional impairments in the wake of sports-related     concussions.   "
19174|NCT03034707|"     The B vitamin biotin is widely available as an over the counter supplement, often advertised     and used to promote health of hair, skin and nails. Commercially available over the counter     biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the     recommended dietary allowance). The biotin molecule is also sometimes used as part of the lab     technology to measure hormone and protein levels in the blood. It is possible that high doses     of ingested biotin may interfere with accurate hormone or protein measurement using biotin     related in vitro measurement systems. Such interference, if present, could lead to     misdiagnosis. The study will analyze laboratory levels obtained with streptavidin-biotin     assay systems while ingesting biotin in currently available high dose supplements. The data     will be compared to measurements obtained prior to and one week after stopping the biotin     supplement.   "
19175|NCT03034694|"     The effect of teledermatology on length of hospital admission, length of stay, 30 day     readmission rate, and antibiotic use in patients presenting with cellulitis vs     pseudocellulitis in an academic emergency department setting.   "
19177|NCT03034668|"     Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength,     muscle function, and lean body mass      Participants: The acute phase will include 30 participants, and the chronic phase will     include 84 participants. All participants must be healthy recreationally active males between     the ages of 18 and 35 years.      Procedures (methods):      Acute phase: Participants will complete three testing visits as part of as part of a     cross-over design, during which strength and muscle function will be assessed prior to and     following consumption of a supplement. The experimental supplement is a blend of the     botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose     (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).      Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and     metabolic panel, subjective surveys, and strength will be measured prior to and following an     8-week supervised resistance training program, in conjunction with daily supplementation of     FULL, HALF, or PLA.   "
19178|NCT03034655|"     The aim of this study is to evaluate and compare the effectiveness of vestibular     rehabilitation developed using computerized dynamic posturography or a mobile posturographic     system with vibrotactile stimulation, to improve the balance in older people and reduce the     number of falls.   "
19179|NCT03034642|"     The long-term goals of this study are (a) to understand the biological underpinnings for the     increased incidence of community-acquired pneumonia in patients with chronic obstructive     pulmonary disease (COPD) who are treated with inhaled corticosteroids; and (b) to develop     novel therapies to treated this problem using over-expression of micro-RNAs (miRNAs).   "
19180|NCT03034629|"     The overall goal of this proposed study is to assess the reliability of plasticity measured     by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst     stimulation plasticity measures and to assess the influence of an acute bout of aerobic     exercise on TMS plasticity measures.   "
19181|NCT03034616|"     The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients     undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will perform     5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to     the depth of cuts and proximity to blood vessels and later.   "
19182|NCT03034603|"     This triple-blinded randomized placebo control trial aims to investigate the safety and     efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The     primary outcome measure includes adverse events and health-related quality of life. The     secondary outcome includes tumor response and functional status.   "
19183|NCT03034590|"     This study will translate an English case definition of poststroke fatigue and validate it     against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale   "
19184|NCT03034577|"     Trial summary: deep neuromuscular block is proposed as a technique to improve operative     conditions for laparoscopy. Early clinical data would suggest that there may also be patient     benefits beyond the operative period related to lower intra-abdominal pressure, and improved     surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to     use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide     moderate neuromuscular block and reverse with neostigmine. It is not possible to safely     reverse deep neuromuscular block using neostogmine, as the majority of block must have worn     off for neostigmine to be effective. in order to identify whether deep neuromuscular block     improves quality of recovery after surgery, the investigators will conduct a randomised trial     of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic     techniques and drugs used. the outcome measured will be the post-operative quality of     recovery over multiple time periods using the Postoperative Quality of Recovery Scale     (PostopQRS). 350 patients will be enrolled over 4 centres.   "
19185|NCT03034564|"     This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo     for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's     Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well     as the impact of fatigue on daily functioning and activities, including socialization.     Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's     disease-specific health related quality over the last month in 8 different dimensions of     function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8     situations for which the subject will rate the likelihood of falling asleep. There will be a     screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and     telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of     informed consent, concomitant medication review, adverse event review, pill counts, vital     signs (including supine blood pressure), and outcome measurements. Telephone visits will     include review of informed consent, concomitant medication review, and adverse event review.   "
19186|NCT03034551|"     The goal of this study is to test the efficacy of a financial incentives-based telehealth     intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and     increasing adherence to patient self-care - specifically by incentivizing adherence to     prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the     treatment arm will be given a cellular-connected scale to use at home, as well as a mobile     app on their smartphone that tracks their adherence to daily self-weighing through the scale     and cardiac medications via patient photo submission. The health care team will intervene if     a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of     $150 are offered for full adherence over 90 days. Each day where the patient does not step on     the scale and complete a medication check-in will result in a deduction of $2 per day from     the incentive amount to be paid out. The control group will receive the usual discharge     instructions as prescribed by their health care team.   "
19187|NCT03034538|"     In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with     Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate     clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined     by number of subjects able to complete the study on their originally assigned dosage.     Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised     of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week     measurements. Additional analysis of the effect of Zonisamide on quality of life will be     measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).   "
19188|NCT03034525|"     Acute pulmonary embolism (APE) is a common disease, which involves significant morbidity and     mortality. The clinical presentation of APE has many faces but it is acceptable to suspect     this disease when the patient presenting with at least one of the following: shortness of     breath, pleuritic chest pain, cough, sub-febrile fever or hemoptysis.      The relationship between syncope and APE is not entirely clear. Prandoni et al conducted a     systematic process for the exclusion / confirmation of APE all patients hospitalized for a     first investigation of syncope. In this study APE was diagnosed in about 17% of the patients.     In 12.7% of patients with an alternative explanation for syncope APE was diagnosed.     Interestingly, 25% of the patients had no other manifestation of pulmonary embolism apart     from the syncope itself.      According to the updated clinical guidelines, APE should not be routinely tested as an     etiology for syncope and not systematically excluded. According to the new data presented by     Prandoni et al, this means that a significant percentage of patients hospitalized for an     investigation of syncope are discharged when they are suffering from APE (in most cases     probably an event of unprovoked pulmonary embolism) without treatment with anticoagulants,     making them particularly prone to PE recurrence.      Aim. To examine the incidence of pulmonary embolism (Pulmonary Embolism, PE), and VTE (venous     thromboembolism, VTE) in patients hospitalized for a first investigation of syncope.   "
19189|NCT03034512|"     This is a natural history study of Alpers Huttenlocher Syndrome. Patients will be followed     over time to assess clinical symptoms for the purpose of expanding knowledge of this disorder     in the medical community.   "
19190|NCT03034499|"     A prospective randomized controlled study intended to compare the efficacy of 2 methods of     robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:        1. Via single-port.        2. Via multi-port.   "
19191|NCT03034486|"     This study is a single sequence, 3-period, multiple-dose study to evaluate the     pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of     D930 in healthy male volunteers.   "
19192|NCT03034473|"     The objective of the TransValid-KFO179/GRCSG-Trial-A is the validation of potential     biomarkers. These are predictive (Prediction of probability of response to a certain therapy)     / prognostic (predicting long-term outcome) microarray-based gene expression signatures and     immunohistochemically evaluated biomarkers. The evaluation was done within the KFO179     (www.kfo179.de) - the validation is implemented in this trial.      Therefore tumor material of patients undergoing standard radiochemotherapy will be analyzed     from pretreatment biopsies an residual tissue from the resection specimen after surgery. This     validation and the biomaterial asservation will be incorporated into clinical routine in all     participating centers as a model for the treatment of solid tumors. The obtained biomarkers     with a predictive and prognostic power will be used to develop an algorithm to predict     patients at high risk of local and distant cancer recurrence.   "
19193|NCT03034460|"     Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using     intra-individual comparison involving subjects with acne vulgaris on face to evaluate the     efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.   "
19194|NCT03034447|"     Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who     suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma more     difficult to control.      As girls usually have a more severe asthma than boys, the investigators believe that girls     have a higher risk of sleep apnea.      To test if asthmatic girls have more sleep apnea than boys, the investigators are going to     ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators     are going test the lung function and how many times they stop breathing during the sleep. The     sleep test is going to be performed in children's home.      In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when     they have an asthma attack. We also are going to look if sleep apnea increases the number of     hospitalizations and asthma attacks in the past 12 months.   "
19195|NCT03034434|"     Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine     the process of cervical recuperation post delivery.   "
19196|NCT03034421|"     Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low     interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment     approach, it is associated with complications the most common of which is pneumothorax with a     rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after     valve implantation may reduce the risk of post-interventional pneumothorax.   "
19197|NCT03034408|"     Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for     alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this     indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on     impulsivity.      Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as     measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control     subjects.      Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk     taking (as measured by the Balloon Analogue Risk Task) and on the preference for small     immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To     compare subjects with alcohol use disorder and healthy control subjects on these tasks.      Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study     outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps     delivered in the Balloon Analogue Risk Task      Study Design: Randomized, placebo control, cross-over, single-dose   "
19198|NCT03034395|"     This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who     are candidates for surgical resection. The primary objective is to determine the feasibility     of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm     versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant     melanoma after surgical treatment with 1cm versus 2cm margins.   "
19199|NCT03034382|"     the aim of this study is to evaluate the duration of analgesia when either morphine or     nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block     for arthroscopic rotator cuff repair.   "
19200|NCT03034369|"     The goal of this study is to identify outcomes associated with Behavioral Health Integration     (BHI) that matter to patients, to compare changes in outcome over time to measure the impact     of different BHI models on different patients, and to create and maintain an Integration     Learning Collaborative.   "
19203|NCT03034330|"     This study intends to develop a family-based care management intervention with primary aims     to provide time-limited support for family caregivers affected by stroke and to empower     caregivers through enhancing the family adaptation and functioning and increasing their     capacity of stroke care. The objectives include:        1. To examine the effectiveness of the proposed family-based intervention to improve          family, caregiver, and service outcome.        2. To examine the cost-effectiveness of the proposed family intervention.      It is hypothesized that comparing to the control group, the experimental group participants     will have more and significant outcome.   "
19204|NCT03034317|"     The purpose of this research study is to collect more information about the use, safety, and     effectiveness of the NeuRx DPS® in ALS patients.   "
19205|NCT03034304|"     The purpose of this study is to determine whether the MASCT-I alone and in combination with     chemotherapy drug are safe and effective in the treatment of advanced bladder cancer and soft     tissue sarcoma   "
19206|NCT03034291|"     Metabolic syndrome (MS) is a clinical entity that includes several disorders that predispose     to imbalance in lipid metabolism: hypertension, insulin resistance, hypertriglyceridemia,     obesity and low levels of high density lipoprotein. The SM itself has a great impact on     morbidity and mortality and is also related to increased cerebrovascular risk and Diabetes     Mellitus 2 (DM2). In Colombia, DM2 is one of the 10 leading causes of illness and death in     people over 45 years. It is accepted that insulin resistance is a stage that precedes the     onset of DM2, but there are few alternatives to reverse it or prevent its progression to     diabetes.      The control of insulin resistance requires increased physical activity, reduced body weight     and changes in eating patterns, measures that are not easily adopted in modern Western     society.      There is evidence of the effect of chocolate consumption on increasing insulin sensitivity in     both hypertensive diabetic patients as well as in normal individuals, apparently because of     the ability of cocoa polyphenols to increase the bioavailability of nitric oxide, Formation     of reactive species of oxine, optimizing carbohydrate metabolism and modulating     insulin-related cellular signaling events.      A prospective, double-blind, placebo-controlled, double-blind clinical trial evaluating the     effect of 50 g of chocolate with 70% cocoa solids, which contributes at least 430 mg of     polyphenols, is conducted for 8 weeks in The reduction of insulin resistance defined by the     reduction of the HOMA-IR index. In addition, there was an increase in arterial reactivity in     non-diabetic individuals with central obesity and insulin resistance. Likewise, to infer the     effect of this food intervention in the modification of the total cardiometabolic risk of the     participants.   "
19207|NCT03034278|"     The primary objective of this study is to better understand post-discharge utilization of     prescribed opioid analgesic medications following surgery. A secondary objective of this     study is to gain a better understanding of prevailing modes of storage for opioid     medications.   "
19208|NCT03034265|"     The purpose of this study is to determine the concentrations and variabilities of urinary     exosomal sodium channels and plasma angiotensins in patients with difficult-to-treat arterial     hypertension and to investigate their dependency on clinical parameters and sampling     conditions.   "
19209|NCT03034252|"     Retrospective Evaluation of Survival after Liposarcoma   "
19210|NCT03034239|"     Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks     of resistance training.      Hypothesis: Insect protein supplementation enhances the effect of resistance training on     muscle mass and muscle strength.      Primary outcome: Muscle hypertrophy and muscle strength      Design: Two groups of healthy young men (age: 18-30 years) with resistance training     experience, but no structural resistance training performed for the last 12 months.     Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric     carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming     to induce muscle hypertrophy.   "
19211|NCT03034226|"     This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in     healthy control subjects with and without antecedent hypoglycemia   "
19212|NCT03034213|"     The hypothesis for this study is complex incisional hernia repair using the separation of     components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will     lead to fewer incisional hernia recurrences and fewer wound complications compared to the     same incisional hernia repair techniques reinforced with other prosthetic or     biologically-derived mesh.   "
19213|NCT03034200|"     The purpose of this study is to learn if a new drug, ONC201 can make tumors become smaller or     go away completely. Investigators also want to learn if ONC201 can prevent new deposits of     cancer from appearing in new places in participants (metastases). A phase 2 study of ONC201     in PC-PG (pheochromocytoma-paraganglioma) and other neuroendocrine tumors will determine     whether inhibition of DRD2 (a member of the dopamine receptor family) is safe in     neuroendocrine cancers including PC-PG.      ONC201 is an investigational (experimental) agent and has a favorable safety profile in phase     1 and early phase 2 clinical trials in advanced cancers. This study design has been chosen to     see whether ONC201 is associated with reduction of anti-hypertension medications, safety and     significant efficacy against neuroendocrine tumors, especially PC-PG.   "
19214|NCT03034187|"     The goal is to gain insight in the development and course of the toxicity after a curative     treatment of prostate cancer   "
19215|NCT03034174|"     The objective of this study is to describe the pharmacokinetics of tigecycline in critically     ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the     frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200     mg loading dose and 100 mg/12h).   "
19216|NCT03034161|"     40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in     this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be     included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages     of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal     distribution can be identified which can then be applied to identify patients at risk of     developing pressure ulcers at an earlier stage in their hospital course.   "
19448|NCT03030989|"     This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after     hematopoietic stem cell transplant in prevention of central line associated blood stream     infections. Half of the participants will use 2% CHG washcloths and other half will use     placebo washcloths.   "
19217|NCT03034148|"     In human purified platelets, only thrombin, and not the other platelet agonists, leads to a     transient activation of the protein kinase activated by AMP (AMPK) and to phosphorylation of     its bona fide substrate, ACC on its Ser79. ACC phosphorylation (P-ACC) can be an     interesting marker of thrombin action on platelets. Indeed platelet and coagulation     interplay, though undoubtedly present in atherosclerosis and atherothrombosis, remains     difficult to assess. Our group showed that atherosclerotic mice (SRBI/Apolipoprotein E     knock-out) had higher platelet P-ACC compared to corresponding control mice (C57BL6). In     agreement with these data, preliminary results showed increased platelet P-ACC in a small     cohort of patients admitted for coronary angiogram, with demonstrated coronary artery disease     (CAD).      In the light of our preliminary results, we sought to analyze platelet P-ACC in a large     prospective clinical trial (ACCTHEROMA) in patients admitted for coronary angiogram. The aim     of the study is to compare platelet P-ACC in platelets of patients with CAD and more     particularly in unstable CAD patients to non-CAD patients. This study could potentially     identify patients at high risk of future ischemic cardiovascular events, because of a higher     level of thrombin generation.   "
19218|NCT03034135|"     This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor     effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their     routine standard of care with TMZ therapy for approximately 6 months. Patients will be     evaluated for response every 8 weeks. Patients will be followed up 2 years after the last     dose of DSF-Cu.   "
19219|NCT03033966|"     Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes     following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage     literature. How the brain injury affects cerebral oxygenation in patients with CVT is not     currently known. Some of the factors that can affect cerebral oxygenation in patients with     CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in     Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how     these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the     cerebral oxygenation.   "
19220|NCT03033953|"     The aim of this study is to investigate the long term adaptations to 11 (elderly) or 12     (young) weeks of strength training when supplemented with native whey or milk. The     investigators hypothesize that native whey will give greater increases in muscle hypertrophy     and strength than milk.   "
19221|NCT03033940|"     The primary objective is to quantify and compare the three-dimensional kinematics of the     cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved     CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.      The secondary objective is to describe the kinematics in terms of range of motion, patterns     of anterior-posterior motion of the nearest medial and lateral points (posterior femoral     rollback) and tibio-femoral internal/external rotation as well as the kinetics during daily     activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto     a chair, standing up from a chair and stair descent by means of video-fluoroscopy.      Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and     to the Center for Orthopaedic Engineering of the University of Denver, where it will be used     within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and     changes in the musculoskeletal system due to the TKA.   "
19222|NCT03033927|"     The purpose of this phase II study is to develop a test to predict response of pancreatic     cancer to different chemotherapy regimens.   "
19223|NCT03033914|"     The aim of this study is to improve the chance of cure for people with higher risk Hodgkin     lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study     drug called Nivolumab when combined with ABVD for the front-line treatment of HL.   "
19224|NCT03033901|"     Background: Sleep disorders, including sleep apnea, are common after traumatic brain injury     and affect recovery and negatively influence participation in rehabilitation. Sleep apnea is     a breathing problem while persons sleep and causes further brain damage and problems with     thinking, daily functioning, and overall health. Earlier diagnosis and treatment is important     for TBI survivors to maximize the recovery process. There is little information that guides     TBI doctors on how to identify sleep apnea during inpatient TBI rehabilitation, a phase in     which people experience the potential for a rapid pace of improvement. The Agency for     Healthcare Research has highlighted gaps in best methods for identifying sleep apnea and     separately in helping consumers with TBI rehabilitation choices. Partnering with survivors,     caregivers, and administrators, investigators developed this study to compare sleep apnea     screening and diagnostic tools in TBI rehabilitation settings. This information will provide     clinicians, providers, and patients with the best information for early identification of     sleep apnea to remove negative influence on the pace of recovery in early phases after TBI.      The Goal: Investigators will compare existing screening (Aim 1) and diagnostic tools (Aim 2)     in TBI patients undergoing inpatient rehabilitation. For the second aim, investigators will     determine if a more accessible diagnostic test is sufficient to diagnose sleep apnea compared     to the traditional method used which is less accessible to consumers. If the more accessible     test is good enough, this will increase recognition of this problem and increase patient     access to earlier sleep apnea treatment.      Stakeholders and Products. TBI survivors, caregivers, researchers, and policymakers working     together on this study helped develop the study questions. Idea exchanges included ways to     reach clinicians and TBI survivors/caregivers via existing educational programming and online     tools for consumers such as fact sheets and patient/caregiver-focused videos. Other     traditional methods will include targeting professional magazines, conferences, and research     journals that reach professionals working with TBI survivors and their families at the time     of admission to rehabilitation and during the recovery process. This study will occur at     rehabilitation hospitals around the country who enroll TBI survivors into a lifetime study     called the TBI Model System funded by the Dept. of Health and Human Services and VA.   "
19225|NCT03033888|"     The long-term goal is to build a sustainable, community-based outreach program to promote     cervical cancer screening among women living with HIV (WLH), thereby reducing related     morbidity and mortality. The strategy for achieving this goal is to develop an intervention     incorporating health literacy approaches and principles of community-based participatory     research. Health literacy is a relatively new concept that has been applied mainly toward     identifying high-risk individuals rather than toward changing health behaviors and outcomes.     The proposed intervention is the first to integrate health literacy into educating WLH to     promote cervical cancer screening. Community Health Workers (CHW) support has also rarely     been incorporated into cancer screening interventions targeting WLH, making the proposed     intervention a uniquely comprehensive approach. Building on recent successful testing by the     investigators of a health literacy-focused intervention to promote cervical cancer screening     in recent immigrant women, the investigators will test whether health literacy-focused     interventions delivered by trained CHWs will be effective in promoting health literacy and     increasing Pap test rates in a new population, WLH. The investigators hypothesize that,     compared to WLH in the control group, WLH who receive the health literacy-focused CHW     intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health     literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.   "
19226|NCT03033875|"     The purpose of this study is to test the psychoeducational program Tele-Savvy. Tele-Savvy     is an internet based, group education program developed from an in person program called     Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group     (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving     healthy lifestyle education and then Tele-Savvy education 6 months later). Each program takes     43 days to complete.   "
19227|NCT03033862|"     Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers (fibrinogen,     C-reactive protein, platelet endothelial cell adhesion molecule, von Willebrand factor,     p-selectin) will be measured and compared following the implantation of Bioreabsorbable     Vascular Scaffolds and Drug Eluting Stents.   "
19228|NCT03033849|"     The user performance evaluation shows whether people with diabetes are able to obtain     accurate measurement results with a blood glucose monitoring system. In this study, user     performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care GmbH),     Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes     Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics     S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.      For each BGMS, measurement procedures for user performance evaluation will be performed with     1 test meter and 1 reagent system lot by the study subjects.      The same meter and an additional test meter will be used for double measurements performed by     study personnel (with the same reagent system lot used by subjects).   "
19229|NCT03033836|"     Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or lamivudine     (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW).      The primary objective of this pilot study is to determine the retention in care of TGW     treated with DTG-TDF-FTC or 3TC      Secondary objectives:        -  To evaluate the efficacy of the antiretroviral regimen at week 48 ;        -  To describe the safety and tolerability of this regimen;        -  To evaluate adherence across 48 weeks;        -  To determine the patient satisfaction with this regimen;        -  To identify individual, social and contextual factors associated with adherence and          retention.   "
19230|NCT03033823|"     This study examine the efficacy of oral magnesium supplementation as an adjuvant therapy for     decreasing intensity of alcohol withdrawal symptoms among inpatients requiring     pharmacological treatment of their AWS. This double blind randomized multicenter clinical     trial planned to treat half of participants as usal plus placebo and the other half as usual     plus magnesium.   "
19231|NCT03033810|"     The study will compare two invasive methods (FFR -fractional flow reserve and     iFR—instantaneous wave free ratio) for assessment of hemodynamic impact of coronary stenosis     on myocardial perfusion. There is a very good correlation between these methods for the     assessment of hemodynamic significance in a broad spectrum of lesions. However, this     correlation decreases significantly near the cut off points for each method. The     investigators will try to find possible explanations for these differences by detailed     morphology assessment of coronary stenosis using optical coherence tomography (OCT), analysis     of gene polymorphisms that play a role in vasodilatation, and by shear stress analysis. The     head-to-head comparison between FFR and iFR is not simple, because there is no gold     standard for assessment of hemodynamic significance. Studies comparing these methods have     used hyperemic stenosis resistance (HSR). For this kind of measurement it is necessary to     measure the speed of blood flow. This is usually done by a Doppler analysis of flow.     Unfortunately, the Doppler signal can yield many artificial or erroneous indicators, and     obtaining a good quality signal is frequently time-consuming. These are the reasons that HSR     has not been used in routine practice. The investigators have developed a new console and     software that can provide real time analysis of the Doppler signal. It allows us to easily     measure HSR, and to differentiate between the FFR and iFR measures through intrabeat analysis     of microvascular resistance (lowest microvascular resistance is an essential condition for     proper pressure measurement). Using this tool, it is possible to automatically identify the     point of lowest microvascular resistance during each cardiac beat. The pressure gradient can     then be measured at that point. This approach can eliminate almost all uncertainties in     assessment of the pressure gradient produced by coronary stenosis. This tool can potentially     improve the existing methods used to precisely reveal a significant stenosis. This should     increase the number of hemodynamic guided procedures.   "
19232|NCT03033797|"     Background: Games using motion capture from webcam have become increasingly popular. A     population that lacks much stimulus in the teaching-learning process has under-explored the     benefits of this kind of games: The Intellectually Disabled. The aim of this study is to     analyse the effectiveness of games with virtual reality in the total reaction time. Method: A     convenience sample of 165 Intellectually Disabled participants will have their performance     measured using a virtual reality game. The intervention is to play two different games twice,     in two sessions with an interval of, at least, seven days between the sessions. Participants     will be randomized between two raters, both master students.   "
19233|NCT03033784|"     The main goal of the study is to look at the effects of intranasal oxytocin on the brain in     Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and     the brain. It affects a wide range of social behaviors and emotions. Investigators also seek     to study how the effects of oxytocin treatment can be affected by genetic, immune and     environmental factors.   "
19234|NCT03033771|"     Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It     is designed to evaluate safety and performance of the MFM for the treatment of chronic type B     aortic dissection. About 35 patients in up to 11 countries will be enrolled and screened per     the protocol-required inclusion, exclusion criteria, in order to obtain 30 completed     patients. For early demonstration of safety and performance, an interim analysis report will     be performed after all patients included will complete their 6-month follow-up.      The study purpose is to determine the safety and performance of the MFM for the endovascular     treatment of chronic type B aortic dissection. It should be noted that the MFM has CE mark     approval for aortic and peripheral artery aneurysms treatment.   "
19235|NCT03033758|"     This study will be conducted in Greek population. The patients who will be selected for study     enrollment will receive inhaled combination of budesonide and formoterol fumarate dihydrate     at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study end points     will be efficacy and safety in patients with asthma.Additional study objectives will be     quality of life, patient satisfaction, severe exacerbation and comorbidities.   "
19250|NCT03033563|"     The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or     severe oligozoospermia after use of ejaculated versus extracted testicular sperms in     different cycles for the same patient.   "
19445|NCT03031028|"     This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,     and moderate protein) in treating epilepsy. Investigators enroll a group of eligible     epileptic children and adolescent who have been referred from epilepsy center to our clinic     and prescribe them ketogenic diet.   "
19236|NCT03033745|"     This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate     safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary     immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric     subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of     ≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three     cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions),     volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly     infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push     Flow Rate Cohort (2 to 7 infusions per week), flow rate per injection site of 25 to 30     mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute). Each     cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate cohort),     repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate cohort).     After 4 infusion weeks at each level, qualifying subjects (responders) will switch to the     next infusion parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose     will remain unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per     week range); only the respective infusion parameter under evaluation will change.   "
19237|NCT03033732|"     This trial evaluates two standard of care treatments for opioid addiction: methadone and     buprenorphine/naloxone. In order to improve patient care, the study will address real-world     treatment conditions, including patient engagement, strict regulations for methadone dosing     (i.e. initially dispensed daily at the pharmacy until stabilisation) vs. flexible take-home     dosing for buprenorphine/naloxone, and treatment adherence, among others. The OPTIMA study is     designed with the intention to support patient-provider decision-making and evaluate health     related outcomes with the overall aim of improving treatment outcomes through enhancing     patient-centered approaches in clinical care.   "
19238|NCT03033719|"     The purpose of this study is to compare the postoperative global morbidity between patients     who have been operated on for a colon cancer by laparotomy and those operated on by     laparoscopy   "
19239|NCT03033706|"     Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients     undergoing supratentorial mass excision. The investigators hypothesize that in these     procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient     hemodynamics intra and postoperatively.   "
19240|NCT03033693|"     Recent studies have shown that deep anesthesia is associated with poor outcome. There is     still lack of randomized controlled trials with large sample size on the effect of depth of     anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The     investigators are performing a randomized and parallel group trial. The aim of the study is     to determine whether there is a causal relationship between the depth of anesthesia and     postoperative clinical outcome in patients undergoing supratentorial tumor surgery.   "
19241|NCT03033680|"     The specific aims of the study are:      Primary: To determine the presence and regional distribution of microglial activation, as     assessed by [F-18]PBR06 PET, in subjects with MSA as compared to healthy controls, at     baseline and at 9 months follow-up.      Secondary:      To assess the relationship between microglial activation and clinical progression at baseline     and follow-up.      Hypothesis: Our working hypothesis is that there is microglial activation in Multiple System     Atrophy and that the presence and regional distribution of microglial activation is different     in MSA versus healthy controls and correlates with disease severity and comorbidities.   "
19242|NCT03033667|"     Comparative study between conventional fasting versus overnight infusion of lipid or     carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time     on-pump coronary artery bypass grafting.   "
19243|NCT03033654|"     The investigators aim to investigate how much two consecutive applications of sunscreen     before sun exposure can increase the quantities of sunscreen applied and decrease the skin     area left without sunscreen compared to a single application. Volunteers wearing swimwear     applied sunscreen in a laboratory environment twice and had pictures taken in black light     before and after. As sunscreens absorb black light the darkness of the skin increased with     increasing amounts of sunscreen applied. The investigators conducted a standard curve     establishing a link between picture darkness and applied sunscreen quantity. Participants     were asked to apply sunscreen the way they would normally do but two consecutive times. No     other advice was given. The level of protection was determined by picture analysis as     measurements of darkness of selected skin sites as well as the percentages of skin area left     without sunscreen in different body regions and in total.   "
19244|NCT03033641|"     The purpose of this feasibility study is to further explore characteristics of ablation     targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial     fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the     termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.   "
19245|NCT03033628|"     The aim of this study is to compare pain during maxillary infiltration local anesthesia     injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration     injection alone in pediatric dental patients.   "
19246|NCT03033615|"     This study will compare the quality of CT images acquired with very low-dose radiation and     processed with commercially available software vs. PixelShine processed images. It would     potentially allow imaging facilities to acquire CT scans using lower doses of radiation     without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose     radiation has the potential to enhance patient safety and has significant implications in     imaging practices.   "
19247|NCT03033602|"     The primary goal of this study is to examine whether a brief treatment approach for PTSD is     equally efficacious in the treatment of active duty service members relative to a first line     treatment approach that requires much greater treatment dose.   "
19248|NCT03033589|"     All patients over the age of 16 undergoing primary or revision anterior cruciate ligament     reconstruction with the use of bone-patellar-bone autograft are eligible for the study.     Patients will be randomized pre-operatively to receive either an adductor canal nerve block     (single injection) or a femoral nerve block (single injection). Post-operatively, the primary     outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic     analgesic requirements will be measured.   "
19251|NCT03033550|"     The purpose of this study is to determine whether a mobile health educational intervention     for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in Primary     Care settings is a feasible behavioral intervention to integrate as a primary and secondary     cervical cancer prevention approach.Study Design: The investigators will conduct an open     feasibility proof-of-concept trial using a single experimental group with all subjects     receiving the behavioral intervention being studied.      Outcome measures. The primary outcome of interest is receipt of the first dose and completion     of the three-dose series of HPV vaccine within 6 month of intervention, this will be     evaluated by Electronic medical review review.   "
19252|NCT03033537|"     Introduction: Erectile dysfunction is a common condition with a significant effect on quality     of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes     the tone of the smooth muscles lining blood vessels, leading to their dilatation.   "
19253|NCT03033524|"     Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial      Study objective:        1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.        2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent          glioblastoma.        3. Exploratory             -  To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent               glioblastoma             -  To evaluate pharmacodynamic (PD) parameters by clinical biomarker test      Study Methodology      Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next     arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or     other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to     determine the patient's safety with a decision on enrollment into the next arm or change in     dosing frequency of study drug in the above case.      A patient who is withdrawn from the study before the completion of the 1st cycle can be     replaced with another patient. Patients will be treated for up to 1 year, unless a cause for     termination occurs, such as progression of disease (PD) or the withdrawal of consent.   "
19254|NCT03033511|"     This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and     multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy     following first-line platinum-based chemotherapy.   "
19255|NCT03033498|"     The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of     single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by     a continuous subcutaneous infusion in subjects with Parkinson's disease.   "
19256|NCT03033485|"     The purpose of this study is to assess the dosimetric properties of the positron emission     tomography (PET) imaging probe 18F labeled Picolinamide (18F-P3BZA) and preliminarily     evaluate its diagnosis value in melanoma patients.   "
19257|NCT03033472|"     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect     of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical     periodontitis.   "
19258|NCT03033459|"     Breastfeeding is good for the health of both mother and baby, but many women do not     breastfeed, or do not breastfeed for as long as they would like. The purpose of this study is     to compare two types of interventions on how they impact breastfeeding. The interventions     will be given during the third trimester of pregnancy, and the intervention is individual     (i.e., one therapist and one participant). The first intervention is Motivational     Interviewing, a type of counseling. The second intervention, or control group, is education     on how babies grow and develop. There general aims of this study are to compare women in the     Motivational Interviewing group and control group on how they plan to feed their babies, how     much they learn about and their opinions about breastfeeding, and how much they learn about     how babies grow and develop. In addition, the groups will be compared as to whether they     start breastfeeding, and how they are feeding their baby when the baby is one month old.   "
19259|NCT03033446|"     The purpose of this study is to evaluate the effect of liver-localised radioembolization and     nivolumab on liver cancer.   "
19260|NCT03033433|"     An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating     Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in     Type 2 Diabetes Mellitus (T2DM) Patients   "
19261|NCT03033420|"     Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality     due to mental and substance use disorders, and burden society with the highest health care     costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric     hospitalization is a major burden. Smartphones comprise an innovative and unique platform for     monitoring and treatment of depression and mania.      The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients     with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region     of Denmark are invited to participate. Patients are at discharge from the psychiatric     hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial     consists of two separate trials according to diagnosis, bipolar disorder or unipolar     disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback     loop between patients and clinicians and b) context-aware CBT modules (intervention group) or     2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in     March 2017. The outcomes are 1) differences in the number and duration of re-admissions     between the intervention group and the control group (primary), 2) differences in severity of     depressive and manic symptoms (manic symptoms only for patients with bipolar disorder);     differences in psychosocial functioning; and differences in number of affective episodes     between the intervention group and the control group (secondary), and 3) differences in     perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms     (only for patients with bipolar disorder), recovery, empowerment, adherence to medication,     well-being, ruminations, worrying, and satisfaction between the intervention group and the     control group (tertiary).   "
19262|NCT03033407|"     The aim of this study is to investigate whether adding tailored mobile coaching system to     present community primary care for diabetes management would result in better glycemic     control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared     with maintaining usual diabetes management only.   "
19263|NCT03033394|"     Currently in the UK, TDM is routinely performed for aminoglycosides and glycopeptide     antimicrobial agents, given fears over the narrow therapeutic window of these agents and the     serious adverse events associated with toxicity. However, in critical care the role of TDM     for optimisation of therapy has been demonstrated to help optimise dosing of patients who     tend to have variable pharmacokinetic parameters (J. A. Roberts et al,). This is of growing     importance given that low concentrations of antimicrobial agents, below a micro-organisms     minimum inhibitory concentration (MIC) is believed to be a major driver of AMR. The     investigators set out to explore whether similar observations in PK-PD target variability are     currently being observed across the secondary care setting (outside of critical care) and     whether these appear to be impacting on clinical outcomes.   "
19264|NCT03033381|"     Here, investigators aimed to evaluate the effect of inguinal operations performed with a     modified Ferguson technique upon testicular volume and blood flow. This study involved 23     patients receiving surgery for inguinal hernia, hydrocele, and cord cyst. The color Doppler     ultrasound (CDUS) was used to assess testicular volume and blood flow before and after a     modified Ferguson technique surgery. The pre- and postoperative testicular volume and blood     flow were compared with the contralateral testes. Statistical Package for the Social Sciences     (SPSS) software was used to statistically analyze the data arising; the Mann-Whitney U test     and Friedman test were used to compare samples, and P < 0.05 was accepted as statistically     significant.   "
19265|NCT03033368|"     To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from     EFV to RPV in virologically suppressed adolescents   "
19266|NCT03033355|"     The purpose of this prospective research study is to evaluate higher neural changes following     intradetrusor injection of Botulinum toxin-A (BTX-A) in patients with Multiple Sclerosis     (MS). Concurrent Urodynamic and Functional Magnetic Resonance (fMRI) data will be recorded     pre- and post- intravesical injection of BTX-A in patients with Multiple Sclerosis (MS) and     neurogenic detrusor activity (NDO).      Other objectives are to evaluate the role of urinary biomarkers such as brain-derived     neurotropic factor (BDNF) and nerve growth factor (NGF) associated with bladder overactivity     and, to determine whether the common validated urgency questionnaires correlate with fMRI     findings and urinary biomarker concentration pre- and post- BTX-A injection in patients with     MS and NDO.   "
19267|NCT03033342|"     A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone     antibiotic. Cohorts of healthy adults (female and male) will participate in:      single dose escalation study of increasing doses of MRX-4 given by mouth others will     participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.      other cohorts of subjects will participate in the study to evaluate the impact of concomitant     food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4   "
19268|NCT03033329|"     A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone     antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation     study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will     participate in a multiple dose escalation study of increasing intravenous doses of MRX-4     given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable     intravenous dose of MRX-4 to determine bioavailability.   "
19269|NCT03033316|"     Oncocort Dexamethasone sodium phosphate encapsulated in so-called 'long-circulating'     PEGylated liposomes is in development with the prospect of providing enhanced and prolonged     lesion uptake of dexamethasone and therefore increased therapeutic benefit over existing     formulations of dexamethasone in Multiple Myeloma. The current trial is a first-in-man study     with Oncocort monotherapy with the objective to assess safety, tolerability, efficacy and     dose response after short-term treatment with repeated infusions.   "
19270|NCT03033303|"     The purpose of this study is to test see the combined effects of the study drug called     Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor     (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also     cause side effects.   "
19271|NCT03033290|"     Allergic rhinitis is an importance disease in Taiwan with its high incidence about 20-30% and     gradually increased annually. However, symptom relapse still bothered the majority of     patients though there were certain advances in western medicine. In addition, side effects of     western medicine, such as lethargy, mouth dryness were noted. Traditional Chinese medicine,     especially qi-tonifying regimen has been used and proved benefit to the allergic diseases by     many researchers.This study will provide the evidences of gut microbiota changes and     immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.   "
19272|NCT03033277|"     There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of     the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work     well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer,     and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been     previously documented. Herein the purpose of this work is to evaluate the therapeutic     potential of cell therapy in women suffering from POI.   "
19273|NCT03033264|"     Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor     to 4 groups depending on the mode of labor induction and BMI value:        1. Dinoprostone in women with a BMI>30.        2. Dinoprostone in women with a BMI<30.        3. Cervical ripening balloon in women with a BMI>30.        4. Cervical ripening balloon in women with a BMI<30. The subjects will be followed until          labor, and information regarding the success of induction, mode of delivery and time of          delivery will be collected from patients` electronic files.   "
19274|NCT03033251|"     Chronic obstructive lung disease is a disabling disease that affects people usually after     several years of smoke tobacco exposure and affects millions of patients worldwide. The     disease is marked by multiples episode of worsening, termed exacerbations necessitating     frequent hospitalizations. During these exacerbations, patients present breathless, and in     the most severe cases, are admitted to an Intensive Care Unit (ICU) for respiratory     assistance. Currently, respiratory assistance is provided by a ventilator via a oronasal mask     (referred to non-invasive ventilation, NIV), that helps patients to cope with their     breathless. The mask is not always well tolerated and the ventilator sessions are delivered     intermittently. In the past decade, a new technique that provides air-oxygen with high flow     has been developed. This technique, called High Flow via Nasal Cannula (HFNC) can deliver     from 21 to 100% heated and humidified air-oxygen at a high flow of gas via simple nasal     cannula. Recent studies have shown that the technique is very efficient to treat patients     presenting with acute respiratory failure who don't have any underlying chronic pulmonary     disease. Whether the technique would be also efficient in patients with COLD presenting with     severe exacerbations has not yet been demonstrated. Since HFNC does not require any mask, it     is thought that the comfort of the patient would be much better in comparison to NIV and     could potentially help to treat many patients with the disease. The objective of the present     study is to study the physiological effect of HFNC as compared to NIV in patients with severe     exacerbations of COPD and to show that it is non-inferior to NIV.   "
19277|NCT03033212|"     This investigation will assess how the timing and type of rehabilitation after a     transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure.     The efficacy of the procedure will be evaluated through patients' quality of life, measured     by health-related quality of life questionnaires up to 24 months following the procedure.     These measures will be compared to the patients' baseline value.   "
19278|NCT03033199|"     Primary immune thrombocytopenia (ITP) is an acquired autoimmune bleeding disorder, accounting     for about 1/3 of clinical hemorrhagic diseases. Loss of immune tolerance leading to increased     platelet destruction and decreased platelet production is the main pathogenesis of ITP.     Dysbiosis of the gut microbiota was found in many autoimmune diseases like rheumatic     arthritis(RA),inflammatory bowel disease(IBD),multiple sclerosis and probiotic treatment or     fecal microbiota transplantation(FMT) which can regulate the gut microbiota has good clinical     efficacy in those disorders. One ITP patient with ulcerative colitis(UC) was treated with FMT     and got progressive but significant increase in platelet level and lasted for several years.   "
19279|NCT03033186|"     Metastatic (HR-positive, HER2-negative) breast cancer (BC), advanced or unresectable     neuroendocrine tumours of pancreatic (pNET), gastrointestinal or lung origin and metastatic     renal cell carcinoma (mRCC) are diseases with poor outcome. Everolimus increases patients'     median progression-free survival (PFS) with 4.6 months in metastatic BC (mBC), 7 months in     (p)NET and 3 months in mRCC. However, serious adverse events (AEs) occur frequently. This     reduces effectiveness of everolimus, because AEs are managed with dose reductions, treatment     interruptions or even complete discontinuation of everolimus.      Therapeutic-drug-monitoring (TDM) is used to adjust the prescribed daily dose, to maintain     effective everolimus whole blood concentrations, with the lowest possible risk of AEs. While     everolimus TDM has been common in transplantation medicine, it has not been implemented in     oncology.      The importance of TDM in oncology is supported by previous research which showed that a     2-fold increased everolimus whole blood trough concentration was associated with a short-term     risk of grade ≥ 3 pneumonitis, stomatitis and metabolic events. Moreover, an     exposure-toxicity relationship of everolimus in patients with thyroid cancer was observed,     since initial everolimus concentrations could be associated with early toxicity (< 12 weeks,     e.g. stomatitis). However, the association between initial everolimus measurements and     long-term AEs (≥12 weeks, e.g. pneumonitis, anorexia and anemia) of any grade and the need     for everolimus dose reductions could not be made. Since levels ±>18 µg/L were associated with     toxicity, the investigators assume that the upper therapeutic window of everolimus in the     oncologic setting will be ±18 µg/L. Similarly, a tendency to improved PFS and overall     survival was observed when Cmin in steady state was above 14.1 μg/L. This seems to be the     lower limit of the therapeutic window.      Before consensus about the feasibility of everolimus TDM in the oncologic setting can be     achieved, a number of questions (the knowledge gaps) need to be answered: 1. It is unknown     whether everolimus whole blood trough levels (over time) predict long-term AEs. 2. The     optimal concentration range for everolimus, with the treatment of mBC, mRCC, or (p)NET is     unknown, especially the upper limit associated with toxicity. 3. It is unknown what     everolimus concentration level is associated with the need for everolimus dose reductions.   "
19280|NCT03033173|"     An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and     compared between carpal tunnel syndrome patients and healthy volunteers.   "
19281|NCT03033160|"     The specific aim of this protocol is to determine whether vaginal estrogen is an effective     treatment for asymptomatic microscopic hematuria in postmenopausal women. The investigators     hypothesize that women who use vaginal estrogen for three months will be more likely to have     resolution of their asymptomatic microscopic hematuria compared with women who do not use     vaginal estrogen.   "
19282|NCT03033147|"     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect     of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative     pain and swelling in adult patient with symptomatic apical periodontitis.   "
19283|NCT03033134|"     The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in     Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism     in Japanese Clinical environment   "
19284|NCT03033121|"     Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered     daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is     often not complied. The auxological effect of three injections per week (TIW) regimen is     controversial, while the metabolic effects were never evaluated in children. The objective of     this study was to evaluate whether two different regimens of weekly injections could lead to     similar auxological and metabolic effects in children with GHD.   "
19285|NCT03033108|"     This is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy     secondary to Stargardt disease.   "
19286|NCT03033095|"     The aim of this trial is the caracterisation of a predicting algorithm of the answering     response for patients with etanercept treatment in spondyloarthritis disease.      This algorithm will help to target patients patients who have a risk / benefit important for     etanercept treatment.   "
19287|NCT03033082|"     Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent     inability to obtain and/or maintain a penile erection that is hard enough for satisfactory     sexual intercourse. The number of reported patients with ED is increasing and it is becoming     a real medical problem.   "
19288|NCT03033069|"     To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as     monotherapy or combination therapy (Zoloft) in adults with PTSD.   "
19289|NCT03033056|"     Anxiety disorders are among the most prevalent, costly, and disabling mental illnesses. One     central, yet largely understudied, abnormality in anxiety disorders is the heightened     tendency to display fear and avoidance in reaction to benign or safe events that resemble     feared situations. The current project maps brain circuits associated with this abnormality     in order to contribute to future brain-based diagnosis and treatments for clinical anxiety.   "
19290|NCT03033043|"     This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed     to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B     aortic dissection. The primary endpoint will measure all-cause mortality at 30 days     post-procedure.   "
19364|NCT03032081|"     The investigators will assess the efficacy and safety of utilizing high-intensity interval     training in stable heart failure patients on functional outcomes. Specifically, an assessment     of baseline peak oxygen uptake and peak cardiac output will be assessed before and 8 weeks     after intense interval training. Measurements of quality of life will be assessed before and     after training as well as the number of arrhythmic events before and after training. The     control group will be a group that will follow a moderate exercise training protocol over a     similar period.   "
19446|NCT03031015|"     To introduce a novel external-fixation technique using the combination of K-wires and cement.     For comparison, we also included another group of patients who were treated using a mini     plate and screw system. Bone healing, range of motion of the fingers, costs of treatments,     and patient satisfaction were assessed.   "
19291|NCT03033030|"     Breast cancer remains a worldwide big killer with a rate of deaths compared with newly     diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early     detection of clinically occult breast cancer. Mammography is established as the primary     investigation for population-based breast cancer screening. Advances in mammographic     technique regarding both hardware and software applications are still not sufficient to     overcome mammography's limitation with regard to both sensitivity and specificity. Depending     on several factors, such as age and breast density, mammography screening is associated with     a false-negative rate of 10-20 %.      Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using     3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired     in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of     lesion visible due to the reduction of overlapping breast tissue.      In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow     the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of     discrete projection images while the breast remains in compression. The individual projection     images are extremely low in dose, so the composite dose incurred during a TS acquisition may     be similar to that of a standard 2D mammography. The radiologically dense breasts are     associated with decreased sensitivity of mammography, both in the clinical and screening     setting as well as its established association with breast cancer risk. The systematic     application of ultrasound (US) in women with radiologically dense breasts and negative     mammogram has been shown to be associated with an additional cancer detection rate [7,8,9].     Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52%     of ultrasound-screened women in different density categories [10]. In addition, the main     limitation of US in breast screening is represented by false- positive findings. These     findings result in additional investigation or unnecessary surgical biopsy [10].   "
19292|NCT03033017|"     This is a two-center study of 30 HIV-infected participants who have been on antiretroviral     therapy (ART) for at least two years.      Participants will be asked to undergo LN and GALT biopsies both before and after a closely     monitored analytic treatment interruption (ATI).   "
19293|NCT03033004|"     Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment     groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion     Cryolipolysis. The region will be treated according to the individual need, in the region of     abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60     and 90 days after randomization. Blood collections will also be performed at baseline and     between 14 and 21 days after randomization for evaluation of lipid profile and liver     function.   "
19294|NCT03032991|"     The prospective multicenter study GD-Brain provides a better knowledge on the basis of     neurological impairment in children born to mothers with gestational diabetes (GDM). GDM     modifies placental structure and affect materno-fetal nutrient transfer. Docosahexaenoic acid     (DHA) play an important role on neurodevelopment, and it is reduced in venous cord blood of     newborns born to GDM. In previous studies, we have already demonstrated impaired DHA fetal     levels not only using label fatty acids with stable isotopes administrated to pregnant women,     but also in observational studies in GDM as the prevention of obesity study (PREOBE study) in     Granada and other similar study in Murcia. The impaired cord DHA levels were associated to     disturbed neurodevelopment in these children during the first year of life. However, it is     uncertain the mechanisms underlying this impaired materno-fetal DHA transfer and implications     for later life.      The recent publication in Nature Journal of a selective transmembrane carrier for DHA in     brain named major facilitator superfamily domain 2a (MFSD2a) open new expectations. We     detected disturbed MFSD2a levels in placentas from GDM which could be due to structural     problems in this organ; inflammation, oxidation and metabolic changes related to diabetes     might affect MFSD2a activity. Moreover, it is difficult to know whether disturbed MFSD2a     levels in placenta may also indicate altered levels of this carrier in the brain from     children born to GDM mothers, which could contribute to neurodevelopment impairment in these     subjects. Recent studies also indicate that obesity alters the biosynthesis of eicosanoids     derived from DHA, with a decrease of protectins and resolvin of D-series, which have powerful     anti-inflammatory properties.      The main aim of this study is to analyse potential differences on neurodevelopment, and brain     structure and functioning, in children 8 years old born to GDM respect to those born to     healthy normoweight mothers, as well as to identify early biomarkers consistently related to     neurodevelopment from early stages of life.   "
19295|NCT03032978|"     Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in     two-step indirect pulp treatment: Randomized clinical trial   "
19296|NCT03032965|"     The purpose of this study is to determine if additional ablation during the first procedure     as the result of the ability to medically induce quiet atrial arrhythmias will improve     clinical outcome in patients with atrial fibrillation thus decreasing the need for additional     ablation procedures.   "
19297|NCT03032952|"     This was a 12-week, parallel randomised controlled trial, including a 6-week follow-up. The     trial compared a group of university students (N = 84) receiving a mobile CBT application     intervention (Feel Stress Free) to a wait-list control group (N = 84) receiving no     intervention. Participants were asked to complete the Hospital Anxiety and Depression Scale     (HADS) and the Patient Health Questionnaire (PHQ-9) at baseline (as part of the screening     questionnaire) and then fortnightly for the 12 weeks. Although blinding was not possible     owing to the nature of a wait list control group, researchers did not have any face-to-face     contact with the participants, as recruitment and participation in the study was entirely     completed online.   "
19298|NCT03032939|"     Intraoperative stress responses (vasoconstriction and changes in heart rate) and     postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in     tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter     (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious     stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component     of PPG. The aim of this study was to investigate the effect of a known noxious stimulus     (endotracheal intubation) on both the AC and DC components of PPG.   "
19299|NCT03032926|"     The goal of this proposed study is to identify a potential biobehavioral marker of CBT     outcome in the most common child and adolescent anxiety disorders, including separation     anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to     replicate in a clinical sample the previous finding from animal and non-clinical human     samples that a difference exists in extinction learning across development.   "
19300|NCT03032913|"     The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis     of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry     the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will     examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of     patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.   "
19301|NCT03032900|"     This study aims to describe incidence of right ventricular dysfunction after major lung     resection with echocardiography criteria.   "
19383|NCT03031834|"     Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were     randomized to receive quinapril or no treatment for 2 years.   "
19384|NCT03031821|"     This is a multi-centre, double-blind, randomized phase III trial comparing metformin to     placebo in patients with advanced prostate cancer starting intermittent androgen deprivation     therapy.   "
19302|NCT03032887|"     The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response     syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is     steadily rising in Germany. The hands of the staff and visitors are the most important     transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures     for the prevention of hospital infections. The different measures of hand hygiene serve to     protect against the spread of contamination of the skin with obligate or potentially     pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited     extent (especially in pregnant women and neonates in perinatal care centers) the primary     prophylactic measures are of great importance.      While the importance of hand disinfection in the staff has been undisputed, there is no data     on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these     stations are common non-compliant persons (especially children!). On the other hand, pregnant     women and young mothers and newborn babies are exposed to a large number of visitors     compared to other stations.      The investigators examine whether special measures (such as voice prompts) have a positive     effect on the rate of performed hand disinfections or consecutively on the infection rate.   "
19303|NCT03032874|"     Patient age 45 year old and above who presented with rectal bleeding at three tertiary     hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the     patients and the colonoscopy data were analyzed   "
19304|NCT03032861|"     This study aimed investigate the chronic effect of orange juice consumption on gut microbiota     and in the bioavailability of flavanones and metabolites by feces, blood and urine analysis.   "
19305|NCT03032848|"     To evaluate the difference of three vaginal estrogens creams comparative with placebo on     improvement of hormonal cytology, local and systemic climacteric complaints, as well as its     endometrial security.   "
19306|NCT03032835|"     Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder     characterized by calcification of dermal arterioles.      There are significant gaps in the understanding of the pathophysiology and risk factors for     calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare     incidence and lack of collaborative approach have been some of the major limiting factors     towards treating calciphylaxis.      The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within     calciphylaxis research by utilizing existing and, when necessary, developing new     infrastructure to support the consent of patients and the collection of dedicated samples for     a calciphylaxis repository.   "
19307|NCT03032822|"     At the Ohio State University, and across the country, surgical patients admitted to the     hospital are over-prescribed a significant amount of opioid medications upon discharge to     home. Recent studies reveal that a large percentage of patients prescribed opioid medications     after surgery have approximately half of the prescribed medication left over. This study aims     to evaluate reported opioid use after surgery in patients undergoing cystectomy in order to     better approach the issue with current opioid use and abuse trends while still providing     adequate medical care and pain management to patients.   "
19308|NCT03032809|"     The aims of this study are to optimize MR imaging and MR angiography sequences and image     reconstruction for 3T magnetic resonance imaging system scanners, which are already used in     the clinical environment on patients with or with suspected intracranial vasculopathies.     Improvements in these areas will have positive implications for medical diagnosis and     treatment.   "
19309|NCT03032796|"     The primary goal of this project is to evidence potential synergistic benefits on cognitive     control processes using a video game (Body-Brain Trainer, or BBT) that integrates cognitive     and physical challenges in a complimentary fashion. Healthy adults will be recruited for a     longitudinal experiment and randomly assigned to one of four study groups to mechanistically     tease apart the possible presence of any synergistic effects on cognitive abilities through     the combination of cognitive & physical challenges.   "
19310|NCT03032783|"     This phase II trial studies the how well donor stem cell transplant works in treating     patients with high risk hematologic malignancies. Giving total-body irradiation and     chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone     marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop     the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may     also replace the patient's immune cells and help destroy any remaining cancer cells.   "
19311|NCT03032770|"     Placenta accreta is a substantially life threatening condition and one of the causes of     maternal morbidity and mortality in the world. According to study done in United Kingdom, The     estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities     overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta     previa. in a tertiary south Italian center, The incidence increased from 0.12% during the     1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of     placenta accreta was 3.7 per 1000 deliveries.   "
19317|NCT03032692|"     The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD     - in the motor performance of patients after stroke. The SWORD system combines inertial     motion trackers and a mobile app, allowing digitization of patient motion and providing     real-time audiovisual biofeedback.      The investigators hypothesize that the biofeedback feedback provided by the SWORD system     improves patient performance, defined as an increase in the number of correct movements.      The design of the study is a cross-over randomized clinical trial. Patients will be     randomized into two groups. Both will perform two separate sessions consisting of one     exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both     experimental settings: with and without biofeedback. Group 1 will perform the exercise with     biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform     the exercise in the opposite order. The SWORD system will be used to record movement data in     both sessions, but the feedback was only active in one of them.   "
19447|NCT03031002|"     Patients with anxiety disorders oftentimes express fear responses to more than only one     fear-inducing object. The principal aim of this study is to examine whether the beneficial     effects of exposure on fear reduction in spider phobia can extend to stimuli which are     conceptually similar to spiders (i.e. cockroaches), but have never been presented during the     respective treatment.   "
19312|NCT03032757|"     Age-associated loss of muscle mass, termed sarcopenia, is strongly associated with functional     impairment and physical disability in the elderly. Maintenance or growth of muscle mass is     mainly driven by increased muscle protein synthesis (i.e. the generation of new muscle     protein) in response to exercise and feeding. However, several investigations have shown that     elderly individuals have a blunted protein synthetic response following protein intake. This     inability of the elderly to properly respond to growth stimuli has been termed anabolic     resistance and plays a significant role in the development of sarcopenia. However, the     precise mechanisms underpinning anabolic resistance are unknown.      It is well established that muscle protein synthesis at the molecular level is regulated by a     cellular protein complex called mTORC1. When exposed to a growth stimulus, mTORC1 has been     shown to associate with lysosomes, i.e. the intracellular organelles responsible for the     breakdown of cellular proteins, and subsequently moving towards the cell periphery.      This movement of lysosome-associated mTORC1 within the cell is believed to be vital for the     activation of protein synthesis, as inhibition of lysosomal movement blunts mTORC1 activation     in response to amino acids. Thus, dysregulation of lysosomal movement in ageing muscle may     represent an underlying mechanism in the development of anabolic resistance. However, this     area of research is unexplored in the context of human skeletal muscle. The investigators     hypothesize that dysregulation of lysosomal movement plays a central role in the development     of age-associated skeletal muscle anabolic resistance.   "
19313|NCT03032744|"     Project IMPACT is a school-based health center intervention program that institutes     guideline-based chronic asthma care and provides supervised administration with daily     preventive asthma medications to improve asthma symptoms and lung function, reduce emergency     visits, and decrease missed days of school among children from communities with health     disparities.   "
19314|NCT03032731|"     Many healthy lifestyle interventions have been developed to help people change their activity     and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and     cardiovascular disorders (CVD). However, these interventions often fail to engage their     target audience, which undermines their effectiveness in changing behaviour and health     outcomes.      The purpose of this study is to investigate the efficacy of a self-directed, website-based     intervention to promote physical activity and healthy dietary behaviours. The intervention     frames health information from a novel perspective, which our previous work has indicated can     help to promote interest in the health information and improve attitudes, self-efficacy and     motivation towards physical activity and healthy dietary behaviours.      The intervention comprises a website of information resources and personal recording areas to     set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim     to see whether the intervention has any impact on people's physical activity and diet, as     well as their risk of developing CVD and T2DM. The intervention will be compared with a     control condition in which participants will be shown standard resources available on NHS     websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be     recruited from the community. The active intervention will last 6 weeks (during this period     participants will receive weekly emails from the research team) and there will be a 6-week     follow-up phase (in which participants will still have access to the website but contact from     the research team). Activity, diet, disease risk markers and psychological antecedents of     behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12-     weeks).   "
19315|NCT03032718|"     Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically     meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic     agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced     or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk     of falling. It is associated with significant disability and poor recovery, not only reducing     patients' autonomy and quality of life but also limiting medical cancer therapy, which     subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be     prevented and approved and effective treatment options are lacking.      Promising results regarding CIPN have recently been achieved with exercise. Own preliminary     work revealed that patients profit from sensorimotor training (SMT), experiencing significant     relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body     vibration training, a further neuromuscular stimulating exercise intervention. Results     suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer     patients but can attenuate motor and sensory deficits.      We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a     follow-up period), including 44 patients with neurologically confirmed CIPN, in order to     evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient     reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include     compound muscle action potentials, distal motor latency, conduction velocity, and F-waves     from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of     the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis     anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris,     peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life     and the level of physical activity. Patients will be assessed before and after a 12 week     intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks     into the intervention as well as every 3 weeks during the follow-up.      We hypothesize that individually tailored whole body vibration training will reduce relevant     symptoms of CIPN. Our results could contribute to improve supportive care in oncology,     thereby enhancing patients' quality of life and coincidentally enabling the optimal medical     therapy.   "
19316|NCT03032705|"     The purpose of this study is to compare esthetic, functional and biological properties of two     restoration materials used to fill cavities. One material is called Filtek™ Supreme which     is a traditional tooth colored resin composite that is placed in the cavity in layers and     hardened with UV light. The second material is called SonicFill™ 2, which is a bulk fill     composite that uses an ultrasonic hand piece to change the material from a solid into a     liquid in order to place it into the cavity. This material can be placed in the cavity in 1     layer, and is hardened using UV light. Both materials have been FDA approved as     non-significant risk devices for filling cavities.      In each subject, one tooth with a cavity will be randomly selected to receive one filling     material, and a second tooth with a cavity will be randomly selected to receive the second     material. The fillings will be observed over a two year period to determine clinical     acceptability.   "
19333|NCT03032484|"     Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.   "
19334|NCT03032471|"     The primary objective of this multicenter observational study is to determine the effect size     of the relationship between DCI and neuropsychological impairment 14-28 days and 3 months     after aSAH.      Secondary objectives are the feasibility to administer and the validity of the MoCA in an     intensive care unit setting, as well as the test/retest reliability of the MoCA in patients     with acute brain damage in absence of aSAH.   "
19335|NCT03032458|"     A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine     gel as analgesics for pain control in shockwave lithotripsy.   "
19318|NCT03032679|"     After Institutional Review Board approval, adult patients scheduled for total knee     arthroplasty (TKA) will be enrolled into the study after obtaining informed consent over a 24     month period. Interim analyses of cases who have completed the 6 month follow up as on 31st     October, 2017 will be analyzed as part of the co- principle investigator's thesis. All     consenting patients will be assessed for pain preoperatively, the first 3 post-operative     days, at 1, 4 and 6 months from the date of surgery. Pain scores will be assessed using the     Numerical Rating Scale during the 3 postoperative days. Pain will be managed by the Acute     Pain Service team as per standard protocols.      The Brief pain inventory (BPI) (short form with translations, obtained with permission from     MD Anderson), which assesses pain severity and its impact on daily functions will be     administered to the patient in a language familiar to them, preoperatively, at 1, 4 and 6     months postoperatively.      The Musculoskeletal Tumour Society Score (MSTS) which evaluates the functional condition     (impairment) after completed tumour treatment will be estimated at the end of 6 months from     the date of surgery The painDETECT questionnaire (PD-Q) a quick, simple and reliable     screening tool to identify the likelihood of a neuropathic pain component in patients and     validated in various languages including Hindi and Marathi will be administered     preoperatively and at 1, 4 and 6 months after surgery.      Details of postoperative chemotherapy and radiation will also be obtained from patient's     notes and the electronic medical record. If the patient cannot follow up at the said     intervals, the pain scores would be obtained telephonically and the BPI and PD-Q forms in     prepaid envelopes would be given to them at discharge which they would have to duly fill in     and post them to the given address at the appropriate intervals if they cannot visit the pain     clinic. At the 6th month of follow up, they would be requested to visit the pain clinic for     an assessment of MSTS score and completing the BPI and PD-Q.      INCLUSION CRITERIA:-        -  Adult patients above 18 years of age, undergoing TKR        -  Literate: able to read and write in at least one of the following languages English,          Hindi and Marathi        -  Willing to fill forms and post them and/or answer questions on phone      EXCLUSION CRITERIA:-        -  Refusal of consent        -  Cognitively impaired        -  Revision TKRs (including cases with wound wash and nail spacer cementing)   "
19319|NCT03032666|"     Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in     transfusion-dependent patients with HCV genotype 1-6      Secondary Objective(s):      Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs.     relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1,     F2 by elastography   "
19320|NCT03032653|"     This single-centre historical control group comparative study will compare outcomes of     surgically-treated rotational ankle fractures and the current routine practice of early     protected weightbearing and range of motion with immediate unprotected weightbearing as     tolerated and range of motion after ankle open reduction and internal fixation.   "
19321|NCT03032640|"     The purpose of this study is to collect data to examine whether short-term consumption of     non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood     sugar levels and in the composition of the bacteria in the large intestine.   "
19322|NCT03032627|"     The purpose of the research is to help researchers understand changes in metabolism in     patients that develop heart failure.   "
19323|NCT03032614|"     This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.   "
19324|NCT03032601|"     Multiple Sclerosis (MS) is a disease in which the myelin surrounding the nerve cells is     damaged which affects functioning. MS usually is treated with medications designed to reduce     the occurrence of future MS events. Evidence suggests that an important part of the disease     process is damage to the myelin and brain caused by too much oxygen (sometimes called     oxidative stress) or too much inflammation (or swelling).      The overall goal of this study will be to determine whether NAC will help to support cerebral     function in patients with Multiple Sclerosis (MS). This PET-MRI study will utilize FDG PET to     measure cerebral metabolism, along with MRI analysis, to measure metabolism and structural     effects of NAC in patients with MS.   "
19325|NCT03032588|"     The main purpose of this study is to assess the safety and tolerability of a single dose of     JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6     cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced     from Salk poliovirus strains (cIPV) as reference.   "
19326|NCT03032575|"     1. To determine the prevalence and incidence of anal HSIL and associated risk factors among     MSM who initiate ART during AHI.   "
19327|NCT03032562|"     Using an extensive set of both volitional and non-volitional tests of respiratory muscle     function and strength it is the aim of this study to        -  identify disease-specific patterns of respiratory muscle impairment in different NMD and          COPD        -  establish which set of tests is predictive of sleep-disordered breathing or daytime          hypercapnia in patients with NMD or COPD, respectively.        -  to investigate the decline of respiratory muscle function in patients with progressive          NMD and COPD along with sleep studies and capnography   "
19328|NCT03032549|"     This study will examine a Ready to Drink (RTD) supplement.   "
19329|NCT03032536|"     This is an open-label, randomized, multi-part study to evaluate the relative oral     bioavailability of a tablet formulation of AL-3778 (formerly NVR 3-778) administered under     fasted and fed conditions (Parts 1 and 2) and the drug-drug interaction between AL-3778 and     entecavir or tenofovir disoproxil fumarate (Part 3).   "
19330|NCT03032523|"     Hypoglycemia is the most common metabolic problem faced after birth. We will be studying the     utility of using a continuous glucose monitoring(CGM) system to more closely monitor low     blood sugars in newborns. We will evaluate the number of hypoglycemic events detected using     CGM and compare it to those detected using current standard of care screening methods.   "
19331|NCT03032510|"     The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of     eravacycline compared to ertapenem in treating participants with complicated urinary tract     infections (cUTI).   "
19332|NCT03032497|"     The feasibility study proposed here will primarily examine the sensitivity of an     electroencephalogram (EEG)-based Brain Computer Interface (BCI) in detecting significant     differences in brain signals in patients with chronic low back pain (N=10), lower limb pain     (N=10) and healthy controls (N=10) through perceived movements via a video and during actual     movements. The BCI device has been approved for use in previous trials (e.g. NNI-IRB/07/001,     DSRB Domain D/09/608, DSRB Domain D/10/072) and the safety and effectiveness of this     non-invasive EEG-based BCI device validated through these trials. However, the validation has     not been specific to its use in pain. Related to the primary objective of the study, we will     develop and validate an adaptive and participant-specific pain detection and analysis program     by exploring and identifying discriminative and robust patterns in spontaneous EEG from our     study sample.      For the secondary objective, we will develop and validate a BCI and computer based pain and     attention diversion training system with interactive audio-visual feedbacks for Phase 2 of     the study. These feedbacks will inform the user about the current brain activation level and     attention level, and guide the user in learning to modulate the EEG characteristics and     develop skills to manage attention to alleviate perceived fear-related pains. The BCI system     captures EEG signals and decodes the underlying brain states in relation to cognition and     fear-related pain perception. Such decoded brain states are then presented to the participant     in visual or other form to guide the participant to learn to regulate the brain states     towards better pain management. For example, the participant may over a few sessions learn to     focus on the visual feedback while inhibiting the brain function activity in relation to     fear-related pain perception. With practice, the user is encouraged to achieve brain activity     modulation without external feedback so fear-related pain can be reduced in realistic     situations.   "
19337|NCT03032432|"     The purpose of this study is to determine if patients with shoulder pain and MRI-confirmed     rotator cuff tendinosis, will have their pain and function improved when treated with daily     use of a dynamic elastic garment along with a corticosteroid injection, when compared to     those patients who receive a corticosteroid injection alone. To our knowledge this is the     first study to evaluate the use of a dynamic elastic garment on shoulders.        -  Group A: Control group, will receive and ultrasound-guided corticosteroid injection          alone.        -  Group B: Intervention, ultrasound-guided corticosteroid injection and scheduled use of a          dynamic elastic garment.      Up to 60 patients will participate and be randomized in this study, both male and female     between the ages of 18 to 89 years of age. Subjects will complete a few forms; SF-36, ASES,     Simple Shoulder test, these will take place at the initial visit and Then again at your 4     week and 6 week visit.      This is a single center study, investigator initiated. 60 subjects will participate in the     study at Loma Linda University.   "
19338|NCT03032419|"     The trial is a phase III, non-inferiority, observer-blind, randomised, controlled,     multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and     IPV SSI (reference vaccine)   "
19339|NCT03032406|"     To evaluate the feasibility of administering HCQ, EVE or the combination in patients who have     completed primary therapy for breast cancer and harbor bone marrow disseminated tumor cells.   "
19340|NCT03032393|"     This study determines the effects of posture on time up and go test. Half of the subjects     will assume a high-power posture, while the other half will assume a low-power posture.   "
19342|NCT03032367|"     This is a randomized, open-label, cross-over study comparing the bioequivalence of     bedaquiline administered in whole tablet form versus bedaquiline administered in crushed     (experimental) form in healthy adult volunteers.   "
19343|NCT03032354|"     They are major genera of bacteria that make up the colon flora in human, constitute     intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal     barrier and modulate local and systemic immune responses. Changes in gut microbiota can     influence the immune system by increasing gut permeability, intestinal inflammation, and     impaired oral tolerance in type 1 diabetes.Taken together, the data imply that     bacteriotherapy may potentially be used as a tool to modulate the immune system for     preventing islet destruction. Supplementation of Lactobacillus rhamnosus GG and     Bifidobacterium lactis BB12 improved blood glucose control in normoglycaemic pregnant women     and reduced the frequency of gestational diabetes mellitus      Aim of the study:      The effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell     function in children with newly diagnosed type 1 diabetes: a randomized, double blind,     placebo-controlled trial.      Primary end point:      Area under the curve (AUC) of c-peptide level during during fasting and at 30,60,90,120 min     following the start of the meal      Intervention:      Included patients will be randomly assigned to receive a combination of Lactobacillus     rhamnosus GG and Bifidobacterium lactis BB12 (Probiotics Group ) or placebo (Placebo Group )     during six months.      The expected results:      Beneficial effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell     function shown in the properly performed, methodologically accurate study would create a     rationale for its routine use in patients with newly diagnosed type 1 diabetes.   "
19344|NCT03032341|"     The purpose of this research study is to find out if mobility (the ability to move around)     can be reliably assessed by having the family or care giver caregiver take a video based test     for the patient. If this study shows that mobility can be assessed by family or caregiver,     this information can be used in situations where mobility cannot be measured directly in     patients. A total of 60 patients and 60 family/caregivers at Wake Forest Baptist Medical     Center will take part in this study. Patients physical function will be assessed using a test     that uses short movie clips to assess mobility. Patients will be asked to watch ten short     (~10 seconds each) movie clips that describe various tasks such as climbing up hills or     walking and estimate if they can perform the tasks. The familymember/caregiver will be also     asked to answer the questions on behalf of the patient. The family member/caregiver will be     asked to return to take the same test in the next 1-14 days. The patient will be in the study     for one day. There is no intervention, this is observational.   "
19345|NCT03032328|"     In previous work the investigator identified a group of children between the ages of 10-18     years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic tests     has unexpectedly revealed underlying cardiovascular instability manifesting as orthostatic     intolerance, primary defined as postural orthostatic tachycardia syndrome (POTS) (88%). While     this is an atypical initial presentation for orthostatic intolerance in general, the     investigator believes that the cardiovascular problem is serious and represents a cause of     the nausea in a majority of these individuals, as treatment of the POTS with fludrocortisone     reduced the symptoms of nausea. While fludrocortisone treatment abrogates the fall in     baroreflex sensitivity (BRS) during tilt in part, it did not completely correct the     tachycardia symptoms or the BRS suppression during HUT. Furthermore it caused an elevation in     MAP in supine position, which may lead to future cardiovascular problems such as early onset     hypertension and cardiac hypertrophy. This argues for a different treatment approach. The     investigator presents preliminary data in this application revealing that OI subjects tend to     have lower 25-hydroxy vitamin D (25(OH)D) compared to non OI subjects.   "
19346|NCT03032315|"     randomized, open-label, single dose, replicate crossover clinical trial to compare the     pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of     telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers   "
19385|NCT03031808|"     When a surgical procedure is performed under general anesthesia, the Airways are often     secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies     have shown a reduction of these side effects when by use of muscle relaxants or a lidocain     spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the     two methods or nothing. These methods will be studied systematically.      Heart rate and blood pressure rise during the intubation procedure. The investigators will     also study the differences between the groups.   "
19527|NCT03030222|"     The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared     with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients     with type 2 diabetes and heart failure (reduced or preserved ejection fraction, ischemic or     non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related     clinical reasons.   "
19347|NCT03032302|"     Traumatic brain injury (TBI) refers to neuronal damage occurring as the result of an external     force being applied to brain tissue. In the United Kingdom annual figures (2013-2014) show     449,000 hospital admittances with a diagnosis of head injury with males up to five times more     likely to sustain a head injury than females. Traumatic brain injury (TBI) causes life-long     disability, with no significant reduction in life expectancy, affecting a diverse range of     cognitive and social functions including memory, task planning and execution, impulse     control, social interactions, personality changes and depression. Following traumatic brain     injury acquired deficits can lead to problems with resumption of aspects of daily life,     particularly in terms of returning to work and interpersonal relationships.      The initial injury triggers a secondary cascade of metabolic, neurochemical and cellular     changes within the brain, primarily aimed at limiting damage and stimulating repair.     Paradoxically prolonged secondary cascade mechanisms, including haemorrhage, oedema,     neuroinflammation and axonal injury, results in exacerbation of deficits observed. The     heterogeneous on-going nature of the secondary cascade presents clinicians with opportunities     to intervene in an attempt to limit neuronal damage. A large body of nutritional research has     been focused on addressing the hypermetabolic and catabolic states created by secondary     cascade processes in the acute stage. Addressing these demands has played a significant role     in reducing mortality and infection rates following head injury, however there has not been     the same depth of research investigating the post-acute period (once individuals are     discharged from hospital).   "
19348|NCT03032289|"     This study aims to investigate the association between active transport and the incidence of     acute myocardial infarction in England.   "
19349|NCT03032276|"     Primary objective of the study is to measure the impact of a comprehensive package of     interventions introduced by the Safe Motherhood Promotion and Newborn Survival project on     neonatal mortality in three Upazila of Chandpur district, Bangladesh   "
19350|NCT03032263|"     Nasal intubation is frequently used for dental procedures to promote an unimpeded view of the     oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal tube     (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits upward     toward the forehead. This unique shape ensures that the tube will not interfere with surgical     exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the trachea     using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this is     possible without an adjuvant, but frequently a pair of specially shaped forceps, known as     Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to     the curvature of these ETT. Magill forceps are introduced into the mouth and are used to     grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the     current literature suggests, it has been our experience that nasal intubations using the     C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL. This     technique may improve the time and ease to intubation because of not having to use the Magill     forceps. The use of Magill forceps can be awkward for the clinician, with poor visualization     due to obstruction of the view by this tool in the airway, and small working space within the     posterior oropharynx. For these reasons, the possibility of not having to use Magill forceps     because the investigators are using a C-Mac as the only tool to intubate is a potentially     inviting one.   "
19351|NCT03032250|"     This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver     support in patients with stage I-IV head and neck cancer. Prepare to Care kit may increase     knowledge about head and neck cancer and enhance stress-management skills.   "
19352|NCT03032237|"     Rationale: Undernutrition risk among community-dwelling older adults in developed countries     is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well     as efficacious to reduce undernutrition in community-dwelling older adults. A promising     strategy to increase protein intake among older adults, is to offer dietary solutions with     normal foods that fit their current daily eating patterns. For this reason, home-delivered     protein-rich readymade meals and protein-rich dairy products will be studied in this     research.      Objective: The primary objective is to study the effectiveness of commercially available     protein-rich readymade meals and protein-rich dairy products in increasing protein intake of     older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary     objectives include: studying effects of these meals and dairy products on total daily energy     intake. Further, studying the acceptance of and compliance to the meals and dairy products.      Study design: The study will be performed as a single-blind randomized, controlled, four-week     trial in a real-life setting: in community-dwelling older adults' own homes.      Study population: The target group of this study are community-dwelling older adults who use     a meal-delivery service.      Intervention: Both groups will receive readymade meals for each day during 4 weeks. They will     also receive dairy products to freely consume during the intervention period. The     intervention groups receives protein-rich meals and protein-rich dairy products, the control     receives standard meals and food products.      Main study parameters/endpoints: Difference in daily protein intake between intervention and     control group. Secondary parameters: energy intake and acceptance (liking).   "
19353|NCT03032224|"     The occurrence of dysphagia is a well-known early feature of esophageal cancer that may     reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a     consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in     patients with esophageal cancer before and after surgery is not well known and its possible     consequences have been debated.      Aim: The aim of this study was to prospectively explore body composition and function in a     cohort of patients with esophageal cancer before and after surgery with curative intent. In     particular, to investigate the prevalence and development of sarcopenia and body composition     as a consequence to surgery for esophageal cancer and the possible relation to morbidity,     length of stay and quality of life (QoL).      Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned for     surgery with a curative intent, data on body-composition measured with bioimpedance, working     capacity (cardiac stress test), grip strength and QoL (European Organisation for Research and     Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version 3.0) were     prospectively collected. Data regarding dysphagia was derived from an esophagus related     quality of life form (EORTC QLQ-OES18). Data on tumour stage and type, complications, length     of stay and preoperative weight loss were collected from medical charts.   "
19354|NCT03032211|"     1. Summary of Clinical Investigation      A summary of the clinical investigation is provided below and includes the primary objective     of the study, the safety and feasibility endpoints, the number of subjects to be enrolled,     the study duration, the subject follow-up and the inclusion/exclusion criteria.        1. Primary Objective           The primary objective of the study is to evaluate the safety and feasibility of the          alfapump® System indication for use in the management of fluid in NYHA Class III and          ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60          mL/min/1.73m2.        2. Study Endpoints             1. Primary Safety Endpoint                The primary safety endpoint will be an assessment of the occurrence of adverse               events (AEs) and serious adverse events (SAEs) related to:                  1. Surgical implant of the alfapump®                  2. Device malfunctions                  3. Dialysate infusion             2. Secondary Safety Endpoints                The secondary endpoint will be an assessment of:                  1. Time to first hospitalization related to fluid management after the activation                    of the alfapump® System and initiation of dialysate infusion has occurred                  2. Rate of occurrence of re-hospitalizations related to fluid management                  3. All-cause mortality             3. Assessment of Feasibility for Fluid Management in Heart Failure Indication The               feasibility of the alfapump® System for management of fluid in NYHA Class III and               ambulatory NYHA Class IV heart failure patients with renal dysfunction will be               assessed by the net fluid balance as measured by the ability of the alfapump®               System to move more fluid to the bladder than dialysate instilled.   "
19355|NCT03032198|"     Thyroid Feasibility Study   "
19356|NCT03032185|"     Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all     women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes,     urogenital pain, headache and pains in the musculoskeletal system. That happens due to the     decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused     by a complex autonomic activity. For pain management, a therapeutic electrical stimulation of     the peripheral nervous system promotes modulation of nociceptive incentives and release of     endogenous opioids. According to reviewed studies, the use of transcutaneous electrical nerve     stimulation (TENS), by directly stimulating the central nervous system, has presented results     of manipulation of the autonomic system, being observed change in heart rate and cognitive     improvement in dementia. Given this possibility, the present study aims to investigate     whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency can generate     autonomic and psychophysical changes in healthy postmenopausal women.      Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on     autonomic and psychophysical parameters in postmenopausal women.      Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected     according to inclusion and exclusion criteria previously established. The autonomic and     psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned     Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively),     as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep     Quality Index). After application of the scales, the participants will be subject to active     Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as     randomization. All the research subjects will be invited to participate in the study and sign     an Informed Consent and Informed (ICI). This study will be registered in the Clinical Trials.   "
19357|NCT03032172|"     This is a multi-center, exploratory, non-comparative and open-label study to investigate the     safety, tolerability, pharmacokinetic (PK) and PK/pharmacodynamic (PD) relationship of     RO7034067 in adults and children with Type 2 and Type 3 Spinal Muscular Atrophy (SMA) who     have been previously treated with a survival of motor neuron 2 (SMN2)-targeting therapy.   "
19358|NCT03032159|"     Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between     parents and their children's' primary care providers about asthma. The overarching goal of     this study is to reduce disparities among a population with high rates of pediatric asthma     morbidity. The investigators are testing the efficacy of a short message service     (SMS)-enhanced health communication (HC) intervention (Text2Breathe) designed to equip     urban, low-income parents with tools for communicating effectively with their children's     primary care provider (PCP).   "
19359|NCT03032146|"     The aim of this study is to examine the contribution of a cardiac rehabilitation program on     the active participation in daily life six months after an acute coronary event.      100 patients will be recruited for the study, 3-10 months after a myocardial infarction and     hospitalization in the Emek Medical Center in Afula, Israel.      50 patients recruited for the study who had participated in cardiac rehabilitation will be     the experimental group. 50 patients who have not participated in rehabilitation- will be the     control group. The groups will be matched for diagnosis, sex and age. Sociodemographic data     on patients will be taken from the medical records of the cardiology department and the     Cardiac Rehabilitation Institute of the Emek Medical Center..      Course of study: Participants will sign an informed consent form and fill out questionnaires     that evaluate active participation in the community. In addition, the physical function and     muscle strength of the participants will be evaluated with designated tests. The duration of     each meeting will be 60 minutes.      HYPOTHESES        1. Patients who participate in a cardiac rehabilitation program will exhibit higher indices          of participation in the community than patients who do not participate.        2. Patients who participate in a cardiac rehabilitation program will display higher levels          of physical activity when compared with patients who do not participate.   "
19360|NCT03032133|"     Patients are randomized to receive pain control after Total Knee Arthroplasty with either a     regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and     mobility is asessed.   "
19361|NCT03032120|"     This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ),     processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on     postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin),     anti-oxidatant status, and prospective food intake in lean and obese subjects.   "
19362|NCT03032107|"     This research study is studying a combination of drugs as a possible treatment for metastatic     breast cancer.      The interventions involved in this study are:        -  Pembrolizumab        -  Trastuzumab emtansine (also called T-DM1)   "
19363|NCT03032094|"     The purpose of this study is to test if the thickness of the graft taken from the roof of the     mouth, has a significant effect on the amount of attached tissue and the amount of root     coverage that are attained when treating a single tooth with gingival recession.   "
19386|NCT03031795|"     Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is     used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after     surgical procedures. When taken orally, it should not cause sedation. The purpose of this     study is to determine if oral ketorolac is effective at reducing pain during IUD placement     versus a placebo tablet.   "
19365|NCT03032068|"     Home monitoring technologies have recently emerged in many different areas of healthcare.     These technologies are being used to provide rehabilitation to patients, and to prevent,     identify, and manage complications. The investigators are proposing a method to monitor and     communicate with patients during the first 12 weeks after total knee arthroplasty (TKA) using     an electronic home-based patient monitoring system with unique connectivity capabilities and     prescriptive controls. The investigators will prospectively, electronically capture range of     motion and gait parameters at specified intervals using Bluetooth sensors worn by the     patient. The unique in-home patient monitoring platform will be utilized by 10 TKA patients     once they return home following surgery. The investigators hypothesize that the use of an     internet based home patient monitoring technology platform will reliably provide information     related to the patients' pain and function and enhance patient feedback and communication     after TKA. The hypothesis will be tested with the following aim: 1) To test the reliability     of all technology utilized within the patient's home including but not limited to the     sensors, the communication controller, the patient interface (Android tablet) and the     internet by prospectively comparing between data collected through the home monitoring     technology and traditional clinical measurements taken during physical therapy and surgical     follow-up visits.   "
19366|NCT03032055|"     Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is     the first cause of death, particularly when complicated by an acute chest syndrome (ACS).      The PRESEV score could help the physicians to better manage VOC and could be used for future     therapeutic trials. This predictive score of secondary ACS has to be validated in a     multicenter international study.   "
19367|NCT03032042|"     Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond     targeted PCR testing to next generation sequencing techniques. In addition, the current state     of monitoring for soil-transmitted helminth infections is moving increasingly from     microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted     helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool     samples are logistically challenging and time-intensive to collect, thus participation is     often far from optimal. Rectal swabs are more efficient and may result in higher     participation. In this study, children will be randomized to either albendazole,     azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be     collected. The investigators will compare the PCR test for soil transmitted helminth     infections using both the rectal swabs and the bulk stool samples. In addition, the     investigators will analyze the gut microbiome of the children using next generation     sequencing techniques to gain insight into effects of mass drug administration.   "
19368|NCT03032029|"     The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation     in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of     life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient     characteristics and to document adverse events related to therapy for a therapy safety     analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the     registry. After the pilot phase will be completed and an intermediate data analysis had been     performed, the registry will be expanded over several countries across Europe with the goal     of enrolling up to 1000 patients over a period of 5 years.   "
19369|NCT03032016|"     Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe     Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic     stem cell transplantation (HSCT), the pharmaceutical company that manufactures Defitelio®     (Gentium, a Jazz Pharmaceuticals Company) - as a specific obligation (SOB) - has been     required by PRAC to set up a disease registry to collect safety and outcome data, and to     assess patterns of utilization of Defitelio® in the post-approval setting. This registry is a     Post Authorization Safety Study (PASS), which is being coordinated through the European     Society for Blood and Marrow Transplantation (EBMT). Following appropriate consent, data from     patients who undergo haematopoietic stem cell transplantation are routinely collected at the     local centre for the EBMT database. For this study, the sites are being asked to collect     additional anonymised clinical data from patients who develop this complication or who have     been treated with Defitelio® for other reasons than sVOD. The study simply requires     collection of data which is already recorded in the patient charts, but not routinely     collected.      The study DOES NOT involve decisions about treatment, which are clinical decisions, but     merely collection of data for patients who develop this complication, whether or not they     receive treatment and for patients who are treated with Defitelio® for any other reasons.   "
19370|NCT03032003|"     To investigate if oral administration of 240mg PAC of cranberries can reduce the number of     episodes of acute bacterial cystitis and improve general QoL in women with recurrent     bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the     adverse effect profile of the drug will be reported.      Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from     the outpatient population who present to their family physician or specialist with     symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will     be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be     taken from all the patients. Antibiotic treatment will be prescribed (using the drug of     choice according to the urine culture and the treating physician choice). Subsequently, they     will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean     240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment     and after a negative urinary culture patients will continue to receive per os, daily, one     capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.      Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection,     vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12     visits.      Participants will be asked about medication usage, any side effects they may be experiencing     at each study visit. If participants develop a UTI at any time during the study, they will be     asked to visit the study site within 24 hours.   "
19400|NCT03031613|"     To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral     pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted     laparoscopic radical prostatectomy (RALRP)   "
19371|NCT03031990|"     Psychological stress and its sources differ among the population and can be reduced in     various ways. The practice of yoga has been shown to be an effective stress reducing agent.     IVF processes have also been shown to increase stress levels, particularly in patients with     multiple failed IVF cycles. Less is known about stress levels in patients undergoing elective     egg freezing for fertility preservation. The investigators demonstrated in a pilot project     that yoga postures with a yoga focused discussion session decreases stress in infertility     patients compared to controls. The goal of this study is to further explore the capability of     yoga practice to reduce stress in a specific subset of infertility patients, those with a     history of at least one failed IVF cycle and those undergoing elective oocyte     cryopreservation. Additionally, the investigators are aiming to understand which aspect of     the intervention (discussion vs. yoga) had the most impact and whether route of     administration of the intervention (in person vs online) effects results.   "
19372|NCT03031977|"     The aim of the present study was to evaluate the effect of visceral mobilization on symptoms     of functional constipation and static balance in stroke survivors.   "
19373|NCT03031964|"     This study will evaluate patients receiving a multihole revision acetabular implant for total     hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of     the implanted prosthesis.   "
19374|NCT03031951|"     Given the lack of support for lifestyle management in post-career and considering the high     rates of physical inactivity and overweight in former elite athletes, the aim of this     research project is to analyze the efficacy and effectiveness of a lifestyle intervention in     former athletes.   "
19375|NCT03031938|"     A4091065 is a multicenter, prospective, cohort study with enhance physical an     neurodevelopmental surveillance to characterize the outcomes related to the development of     infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or     comparator via maternal exposure or in utero in any tanezumb study.   "
19376|NCT03031925|"     There is substantial clinical and biological intra and inter-patient variability in SLE.     Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening,     leading to increased morbidity and mortality.      Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE     patients.      Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models     and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic     cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines     and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR     expression in SLE is significantly higher and significantly correlated with disease activity.      Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or     heterotetramer and is implicated in several biological processes. Most notably, it binds to     ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling     pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated     with SLE.      ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with     ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in     Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated     with a significant increase in vascular expression of ANXA2.   "
19377|NCT03031912|"     This is a randomized, placebo-controlled, multi-site, double-blind trial of V920     (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be     conducted in conformance with Good Clinical Practices. The study will take place at 2     Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital)     and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le     Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including     screening.   "
19378|NCT03031899|"     Abstract      Objective:      To study the diagnostic efficiency of Rose Bengal with Toluidine blue in detecting the biopsy     sites and thus establish an accurate diagnosis in oral premalignant lesions.      Materials and method:      In our study 27 patients with 41 lesions were included. Since one patient had not quit the     habit in the two weeks following initial examination and another lesion disappeared in the     waiting period, 2 patients (3 lesions) were not included in the study. Out of 38 lesions     diagnosed based on clinical criteria, 32 were leukoplakia, 5 lichen planus and 1 SCC. After     initial examination they were subjected to Rose Bengal and Toluidine blue stain. If stained     positive they were subjected to biopsy.   "
19379|NCT03031886|"     Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose     profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.   "
19380|NCT03031873|"     Brain arteriovenous malformations are abnormal communications between brain arteries and     veins with an intervening tangle of abnormal arteries (nidus). Brain AVMs may be asymptomatic     or symptomatic, presenting with acute hemorrhage or neurological symptoms. Brain AVMs that     have not bled carry a yearly risk of intracranial hemorrhage of approximately 4% (Ondra et     al.).      The management is multidisciplinary involving neurosurgeons, interventional     neuroradiologists, radiation physicians, neurologists and allied health care personnel.     Patients may be treated with open neurosurgery, endovascular embolization, radiation therapy     or any combination of these treatments. The goal of the treatment is to eliminate the brain     AVM while preserving normal flow to the surrounding normal arteries. This involves     obliteration of the shunting of blood via the AVM arteries to veins by a variety of     treatments. The treatment regimen is individualized dependent on natural history, the     angioarchitecture, location, risk of treatment(s) and patient wishes.   "
19381|NCT03031860|"     Cough strength score will give true prediction of Extubation outcome   "
19382|NCT03031847|"     This pilot will enroll 50 HF patients (age ≥ 80 years) undergoing CRT device implantation at     the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State     University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P     versus CRT-D and followed until study end. Rates of patient screening, enrollment,     randomization, and retention as well as cost of care will be examined. The results of this     pilot study will inform the design of a large pivotal non-inferiority trial and will be     necessary for its success. Patients who refuse participation in the randomized pilot trial     will be asked to enroll in a prospective observational cohort. Characteristics of patients     who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their     device decision will be measured.   "
19387|NCT03031782|"     This is a double-blind, placebo-controlled, event-driven randomized withdrawal study to     investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic     Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related     Arthritis (ERA). The study is divided into 3 parts (plus a post-treatment follow-up period)     consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a     randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment     Period 2.   "
19388|NCT03031769|"     An observational, multinational, cross sectional study to describe 24-hs symptoms, physical     activity and their relationship in stable COPD patients in Europe   "
19389|NCT03031756|"     The aim of this clinical study was to evaluate the clinical efficacy of using perio flow     adjunctively with mechanical instrumentation on periodontal parameters and halitosis.      Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the     study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control     groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur     compound (VSC) values were measured by a halimeter at the baseline, immediately after     treatment, and at 7 days, 14 days and 1 month.   "
19390|NCT03031743|"     This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial     in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition     and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion     to rotavirus vaccination. The infants will be matched for vaccination dose, age and     breast-feeding practices.   "
19391|NCT03031730|"     This phase I trial studies the side effects and best dose of MDM2 inhibitor AMG-232 when     given together with carfilzomib, lenalidomide, and dexamethasone in treating patient with     multiple myeloma that has come back of has not responded to previous treatment. Drugs used in     chemotherapy, such as MDM2 inhibitor AMG-232, carfilzomib, lenalidomide, and dexamethasone,     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading.   "
19392|NCT03031717|"     Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence     of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased     intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant     flow.      Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is     aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review     the safety and outcomes of this approach.   "
19393|NCT03031704|"     Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be     removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this     technique, albeit less dangerous than surgery, is associated with complications such as     haemorrhages, perforations, and more relapse than that can be observed for colorectal     adenomas. As no prospective data have been published this French multicenter study aim to     analyze results of this technique under standardized and secured procedure.      All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a     group of clinical researcher involved in that field ( GRAPHE  (Groupe de Recherche et     d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly     expected among the international society of gastroenterologists who need to confirm the     efficacy of endoscopy and define optimal conditions for performing adenomas resection in this     location Primary End Point is the two years recurrence rate. Secondary End Points are     frequency and type of complication after standardized endoscopic mucosectomy of duodenal     adenomas, frequency and type of complications after a second endoscopic mucosectomy and     patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring     endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with     previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions,     familial adenomatous polyposis and use of antiplatelet agent during the five last days.      Hundred and twenty patients will be included and followed 2 years after mucosectomy.   "
19394|NCT03031691|"     A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in     Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal     Cancer.   "
19395|NCT03031678|"     The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were     enrolled in the pivotal study to assess long-term safety and device performance.   "
19396|NCT03031665|"     Using an innovative multi-modal imaging approach, this study investigates the role of the     neurochemical gamma-aminobutyric acid (GABA), brain activity, as well as hormones in     understanding sex differences in Major Depressive Disorder (MDD). Further, the investigators     will link these markers to symptoms of depression.   "
19397|NCT03031652|"     Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia     between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h     after surgery was assessed and compared using a visual analog scale.   "
19398|NCT03031639|"     The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This     registry tries to collect the outcomes including quality of life and complication for both     endoscopic and conventional thyroidectomy methods.   "
19399|NCT03031626|"     The aim of this study is to determine if treatment with Medical Air (21% oxygen in room air)     compared to supplemental oxygen (100% oxygen) will lead to similar improvements in the     central apnea-hypopnea index (CAHI) for infants with Prader-Willi Syndrome.      Despite the vast amount of research investigating the cause of central sleep apnea, there     remain gaps in knowledge, lending to further research efforts. The decision to compare oxygen     to medical air is based on several theorized mechanisms. The first of which is the     supposition that provision of medical air may act as an arousal stimulus for the     hypothalamus, thereby preventing sleep disordered breathing. Secondly, the hypercapnic     challenge performed by Livingston et al demonstrated a delayed hypercapneic arousal response     in PWS subjects despite simultaneous hyperoxia, leading us to question if therapeutic oxygen     really plays a significant role in treating CSA. Lastly, the delivery of medical air via     nasal prongs may provide sufficient arousal to terminate the cycle of events leading to     central apnea, as described by Urquhart et al.      A deeper understanding of central sleep apnea is essential to ameliorating its adverse     sequelae, which include symptoms of ADHD, impaired attention, behavioral problems, and     academic difficulties.   "
19401|NCT03031600|"     The objective of this study is to determine the accuracy of estimating patient blood volume     using field-expedient point-of-care measurement of hematocrit before and after hemodilution     with a standardized volume of intravenous solution, in comparison to determining patient     blood volume by radiodilution. A total of 33 healthy adult male subjects aged 18-35 years     will undergo determination of blood volume in a fixed order: first by radiodilution, then by     hemodilution. Blood volume as measured by radiodilution will be correlated with blood volume     as estimated with hemodilution to assess the potential validity of hemodilution as means of     estimating blood volume.   "
19402|NCT03031587|"     Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias     resistant to medication. However, the absence of assessment of injury creation during     radiofrequency application is an important issue. One of the objectives of the Institut     Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is     to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on     thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time     visualization of tissue temperature in all the myocardium with sufficient spatial and     temporal resolution to characterize the induced thermal lesion. Today, investigators have     developed and validated a new method for cardiac thermometry, associating rapid MRI     acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and     correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic     field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium,     largely sufficient to characterize a thermal treatment induced by radiofrequency where     typical temperature rises of 40°C are observed during ablation. Temporal evolution of the     temperature in each pixel provides access to calculation of the accumulated thermal dose that     is a relevant indicator of the induced necrosis.      This imaging method must now be evaluated in humans in order to test its robustness under     real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize     acquisition parameters and image processing. The aim of this research is thus to obtain     specific MRI sequence of images of patients, on which will be evaluated the different     algorithms of reconstruction and processing for temperature imaging. This study is a     mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under     MRI.   "
19403|NCT03031574|"     The purpose of the study is to evaluate the effect of food, gender, and age on the     single-dose pharmacokinetics (PK) of SUVN-D4010.   "
19404|NCT03031561|"     This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting     breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound     sends sound waves into the body, and the sound waves reflected back are interpreted by the     machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives     color to the ultrasound images, which may allow doctors to better identify     microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that     cannot be felt but can be detected by imaging. A group of microcalcifications may indicate     that cancer is present.   "
19405|NCT03031548|"     Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube     (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all     intubations result in inappropriate ETT placement. An adult study has shown that ultrasound     point-of-care is superior to auscultation in determining the location of ETT. This study aims     to determine if point-of-care is useful in determining ETT position in children.   "
19406|NCT03031535|"     The purpose of the study is to investigate the drug octreotide acetate in a new intranasal     formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The     two octreotide acetate formulations will be evaluated following separate administrations for     safety and tolerability including any side effects, the speed at which the drug is absorbed     and eliminated in the body, and the ability of the drug to lower the levels of growth hormone     (GH) and insulin-like growth factor 1 (IGF-1).   "
19407|NCT03031522|"     The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and     repeatable detecting EGFR-activating mutational status.   "
19408|NCT03031509|"     The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial     cells transplant in nonunion of limb fracture patients.   "
19409|NCT03031496|"     The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ)     (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and     hepatic cirrhosis with ascites and edema. This first time in human (FTIH) study is aimed to     determine whether the test product GSK3542503 is bioequivalent to the reference (ref)     hydrochlorothiazide 50 milligram (mg)/amiloride hydrochlorothiazide 5 mg in healthy adult     participants under fasting conditions based on pharmacokinetic (PK) endpoints. This is a     phase I, open label, balanced, randomized, single dose, two-way crossover study, enroling     approximately 42 healthy participants at a single center. Study participants will be     randomized to one of two treatment sequences (A-B or B-A) in accordance with the     randomization schedule. A single dose of one of the two treatments A (Test: GSK3542503, a     hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination) or B     (Reference: Moduretic, a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed     dose combination), will be administered on Day 1, in each treatment period. Each participant     will participate in both treatment periods and receive a single dose of each treatment. The     treatment periods will be separated by a washout period of at least 7 days and no more than     14 days. The total duration in the study for each participant is expected to be 5 to 7 weeks,     from screening to his or her last visit. A maximum of 42 participants will be randomized such     that at least 32 evaluable participants complete the study.   "
19410|NCT03031483|"     Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard     treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy   "
19411|NCT03031470|"     Liver transplantation is currently the treatment of choice for end-stage liver cirrhosis of     different origin, as well as for a number of inborn metabolism disorders and liver tumors.     The need to perform a liver transplantation is high and amounts to 10 - 20 patients per 1     million population per year.      Experimental and clinical evidence demonstrate the harmful short and long-term effects of     ischemia-reperfusion injury (IRI) of the donor organ on the outcome of the intervention     performed. Severe manifestations of IRI of the liver transplant (LT) is one of the main     reasons for the increased length of hospitalization, the high cost of treating patients     during the post- surgery period, the development of persistent early allograft dysfunction or     loss, frequent crises of acute rejection, acute renal and multiple organ failure, and     mortality of the operated patients.      This pilot clinical study is designed to evaluate the efficacy and safety of Reparixin, which     is a new, potent and specific inhibitor of chemokine CXCL8 (Interleukin-8), as an agent to     prevent early allograft dysfunction caused by ischemia-reperfusion injury in patients     undergoing orthotopic liver transplantation.   "
19412|NCT03031457|"     Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis     (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery.     Significant morbidity and mortality is associated with VTE events. This disease entity     represents the most common cause of preventable in-hospital death as evidenced by over     100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial,     with annual costs to the U.S. healthcare system in excess of $7 billion.      Cancer patients have been identified as a particularly vulnerable patient population. Of     these, breast cancer patients represent the largest group treated by plastic surgeons. An     increasing number of breast reconstructions are performed in the U.S. with a documented 35%     increase in the annual number of breast reconstructions since 2000. Over 106,000 breast     reconstructions were performed in 2015 alone.      Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is     associated with the highest risk for VTE. We believe that a key element rendering these     patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is     supported by the observation that VTE risk remains elevated for up to 12 weeks     postoperatively. We hypothesize that lower extremity deep venous system stasis is a     procedure-specific key contributing factor to postoperative VTE risk.      This study examines the duration of postoperative lower extremity venous stasis to identify     patients who might benefit from extended chemoprophylaxis. First, we will use Duplex imaging     technology to examine the lower extremity deep venous system preoperatively, on postoperative     day 1, and on the day of discharge to determine if patients display radiographic evidence of     lower extremity venous stasis at the time of hospital discharge. Next, we will determine if     the use of bridging mesh repair of abdominal fascia will decrease the degree and duration of     postoperative lower extremity venous stasis. Finally, we will examine the association between     bridging mesh repair of abdominal fascia and abdominal bulge and hernia rate at 1 year.      A better understanding of pathophysiologic mechanisms that contribute to the development of     VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE     prophylaxis, thus, favorably impacting clinical outcome in a large patient population.   "
19413|NCT03031444|"     This study was designed to analyze the prognosis and recurrence predictive factors of high     risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.      The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared     for these patients.   "
19414|NCT03031431|"     Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care     (KMC) is a safe and effective method of warming; however, it is not always feasible, and not     possible in settings such as resuscitation or clinical instability. Electric warmers are the     standard of care in developed countries, but are extremely costly, complicated with risk of     causing both hypo and hyperthermia with misuse, and often not feasible in settings without     stable electricity. Through a multi-institutional collaboration, the investigators have     developed an electricity-free infant warmer. After laboratory based prototype testing for     safety and efficacy, the investigators aim to study the supervised use of the warmer under     routine implementation conditions in a resource-limited setting.   "
19415|NCT03031418|"     The purpose of this research study is investigate a new and validated urine test which     predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The     current protocol has two objectives; one is to further assess and evaluate the performance of     the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1)     and two, to evaluate how the results of the urine test influences the decision process for     determining whether to perform a prostate biopsy (cohort (group) 2).   "
19416|NCT03031405|"     The purpose of the study is to examine whether oxytocin and oxytocin receptor gene     polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.   "
19417|NCT03031392|"     Bleeding on probing demonstrated to have high specificity with certain level of sensitivity     to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the     implant surface is imperative to discern on the probe penetration extent and subsequent     bleeding. In the presence of inflammation, bleeding should be present indicating high     sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition     does not seem to translate high specificity. In this sense, it is noteworthy to mention that     the mucogingival shift after implant placement often decreases the presence of keratinized     mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon,     bleeding on probing, although might reliably indicate presence of disease, it does not seem     to be a suitable diagnostic parameter. On the other side, suppuration characterizes the     necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a     sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in     early stages where bone resorption has not occurred yet, it might be a consequence of a     foreign body reaction (i.e., residual cement or floss).      Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always     incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this     case-control study was to assess the diagnostic accuracy of peri-implantitis-related clinical     parameters compared to otherwise healthy dental implants.   "
19418|NCT03031379|"     Randomized controlled trial assessing the safety and benefits of shortening preoperative     fasts on intubated ICU patients undergoing tracheotomy.   "
19419|NCT03031366|"     TIPS creation has been widely used to treat the complications associated with portal     hypertension. In association with increased operator experience and the ongoing development     of imaging modalities, the rate of major complications associated with TIPS has decreased     significantly in the past decades. However, the passage of a curved needle from the hepatic     vein into the portal vein still remains a challenging and time-consuming part of the     procedure and is associated with puncture-related complications that are potentially     fatal.Three-dimensional roadmap guidance has been widely applied in various interventions.     The aim of the present study is to prospectively assess the feasibility and efficacy of     real-time 3D roadmap guidance during TIPS creation.   "
19420|NCT03031353|"     Neonatal respiratory distress may occur in either term or preterm newborns with a higher     relative risk in preterm, and whether born vaginally or through caesarean section, but in a     higher percentage after elective caesarean section whose rate is rising.      Prostaglandins may be given about one hour before an elective caesarean section after     excluding the presence of contraindication to their use to decrease the neonatal respiratory     diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that     occurs frequently in children who had previously TTN will diminish.   "
19421|NCT03031340|"     To see if the administration of 3 dosses of pregabalin (1 dose preoperative, 2 doses     postoperative) will reduce the postoperative opiate requirements of patients undergoing     spinal fusion surgeries of two or more vertebrae.   "
19422|NCT03031327|"     A 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study.      Patients with ocular discomfort following refractive surgery procedure (within 6 months from     enrollment into the investigation) will be evaluated at baseline (Day 1), at Week 2 (day 15±2     days) and at Week 3 follow-up visit (day 22±2, or early exit).   "
19423|NCT03031314|"     Barbed suture use has been gaining increased acceptance and has been reported to offer     potential advantages in wound closure of hip and knee replacement surgeries.      The goal of this study is to compare joint replacement patient outcomes who receive a     knotless barbed suture versus a traditional suture (randomized into two arms). The     traditional suture used at our joint replacement program is defined as: interrupted sutures     to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless     barbed suture and the traditional sutures have similar suture size.      Patient outcomes examined will be patient range of motion (recorded daily) and complications     with wound healing (evaluated periodically in-person at post-operative visits).      Secondary outcomes examined will include wound drainage on dressings by surface area and     weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.   "
19424|NCT03031301|"     The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled     study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation     in subjects with functional constipation.      Two arms will be assessed:        -  Vibrant Capsule administered 5 times per week        -  Sham Capsule administered 5 times per week      Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a     treatment period of 8 weeks.      Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary.      Subjects will be asked to refrain from taking any medication or supplement to relieve their     constipation, during the entire study period.      After the 14 days of run-in period, the subjects will return and eligibility will be     re-assessed. Subjects will be trained on how to use the base unit and will swallow the first     capsule on site the day of baseline visit. They will activate and ingest the rest of the     capsules at home by themselves, using the base unit.      Subjects will be instructed to complete a simple subject eDiary each day throughout the     duration of the study. A final visit will take place at the end of the 8 week treatment     period.      Subjects will receive phone calls at least once a week and subject compliance will be     monitored during the 8 weeks of the study.   "
19425|NCT03031288|"     Aim of the study is to evaluate the effects of vented base bottles on respiration-swallow     patterns and on gastroesophageal refluxes in preterm infants with clinical suspect of     gastroesophageal reflux disease (GERD).      In this crossover-randomized study, we compared the effects of standard feeding bottles (A)     versus vented base feeding bottles (B) on a group of patients with at least 2 clinical GERD     symptoms. 24 hours of synchronized cardiorespiratory (CR) and Esophageal Multichannel     intraluminal impedance (MII/pH) monitoring were evaluated for each patient. During this     period, patients were fed alternatively with feeding bottle A and B.   "
19426|NCT03031275|"     Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center     Karolinska.      Patients: adult survivors treated with ECMO for severe refractory respiratory failure at     least 5 years earlier.      Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary     function testing, exercise tolerance, quality of life and mood disorder screening.   "
19427|NCT03031262|"     In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML)     patients who have reached CR are randomised into two groups and receive high-dose cytarabine     (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is     evaluated.   "
19428|NCT03031249|"     In this open-label, randomized, prospective clinical trial, nucleophosmin-1(NPM1) mutated     acute myeloid leukemia (AML) patients who have reached CR are randomized into two groups.The     control group receive high-dose cytarabine(HDAC) regimen while the experimental group receive     high dose of cytarabine plus tretinoin(ATRA) and arsenic trioxide(ATO) treatment.The safety     and efficacy of ATRA and ATO is evaluated.   "
19429|NCT03031236|"     Background (brief):        1. Burden: The uniqueness of each child is tremendously influenced by interaction between          nature and nurture during critical period of brain development that promotes foundation          of brain architecture through neuronal connections.        2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and          psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental          illiteracy, maternal depression and lack of stimulation, all of which are preventable.          Little is reported about any comprehensive package of development that addresses most of          these early childhood risks and promotes optimum early childhood development (ECD).        3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost, and          feasible center based approach that focuses on positive parenting of children during          early life that will promote early stimulation, minimize childhood maltreatment, boost          up of maternal self-esteem and healthy thinking and improve health and nutritional (HN)          status of children.      Hypothesis (if any):      This integrated intervention will promote maternal child-care practices and mental health     that will finally improve their children's growth, micro-nutrient status, early brain     development compared to control group.      Objectives:      To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status,     child development along with effect on maternal child-care practices and mental health.      Methods:      Randomly selected 2 groups will be identified as intervention and control (150 mothers'     from15 clusters in each group). Mothers of 8-23 months old children living in slums and     practice harsh child-disciplining will be identified as study population. The mothers of     intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will     include combined messages on a) psycho-social stimulation, b) positive parenting to prevent     child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d) health     and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of over 6     month-period). The control group will only receive the usual health messages provided by the     government.      Outcome measures/variables:        -  Children's cognitive, motor, language and socio-emotional development; anthropometry;          hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)        -  Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.   "
19442|NCT03031067|"     One of the major challenge in the field of organ transplantation is the shortage of donor     organs. Many patients waiting for organ transplantation die during the waiting time and many     patients wait for organ transplantation many years with a detrimental effect on their quality     of life, and increasing morbidity and the costs related to. Effective strategies, which     safely extends the donor pool, are therefore advocated. During the last 20 years the two main     policies to gain this purpose were the living donation and the utilization of extended     donor's criteria (ECD). These donors are supposed to yield a lower outcome than the     conventional donors and many research protocols were developed to reduce the preservation     injury (PI) and PI-related complications. Static cold storage (SCS) has been the standard     technique in clinical practice for liver and kidney preservation using particular solutions     (Wisconsin, Custodiol and Celsior) able to prevent cellular swelling. Recently, graft     preservation with hypothermic machine perfusion (HMP) is developing, because it seems to     improve early graft function due to increased tissue ATP concentrations upon reperfusion and     due to the continual flush of the microcirculation which removes waste products.      The addition of oxygen during the perfusion represents an innovation in the methods of     preservation in approved clinical setting seems to add further improvements of the graft. The     present study was designed in order to assess the impact of hypothermic oxygenated perfusion     (PIO) of marginal human kidney and liver compared with SCS.   "
19430|NCT03031223|"     Spinal cord injuries have become increasingly frequent due mainly to the increase in urban     violence. The growing number of automobile collisions and violence-related events merits     particular attention, as such occurrences can lead to death or disability stemming from a     spinal injury. The severity of the consequences depends on the location affected and degree     of destruction of afferent and efferent spinal cord pathways, with higher, more extensive     injuries leading to less physical fitness and functional independence. Unfortunately, injured     neurons of the central nervous system are unable to regenerate following a spinal injury and     spinal cord regeneration is therefore a major challenge to researchers in the fields of     neuroscience and neurologia. Upon receiving an external stimulus, the central nervous system     is believed to adapt and reorganize itself using mechanisms to compensate for neuronal loss     and promote, even if partially, the remodeling of remaining synaptic connections, leading to     new neuronal sprouting. Low-level laser therapy (LLLT) has proven to be a possible option for     the stimulation of the repair process in the central nervous system. It is plausible that     this type of therapy can offer the same benefits previously established in other types of     tissues, the stimulation of bone formation, neovascularization and the regeneration of     peripheral nerves. Research groups have investigated the efficacy of LLLT for the treatment     of spinal cord injuries and have demonstrated that laser therapy administered simultaneously     to an injured sciatic nerve and corresponding segment of the spinal cord accelerates the     regeneration process of the injured peripheral nerve.   "
19431|NCT03031210|"     The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is     non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired     pneumonia in children presenting at a paediatric Emergency Department (ED).   "
19432|NCT03031197|"     The small RCT will assess feasibility, acceptability, and impact of a real-time intervention     on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a     wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a     personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when     they miss a dose, and engage in monthly counseling sessions informed by their adherence data.     Comparison subjects will receive usual care and an offer of counseling at monthly clinic     visits.   "
19433|NCT03031184|"     This clinical trial evaluates whether Mirtazapine or Carbamazepine are more effective than     placebo in treating agitation in people with dementia. The trial will assess the safety,     clinical and cost effectiveness of each treatment. Participants will be randomised to receive     one of the treatments for 12 weeks and will be followed up for up to one year, in this     blinded trial.   "
19434|NCT03031171|"     The goal of the project is to increase colorectal cancer screening within the priority     population of female and male adults age 50 to 85 in Northern Nevada. A successful     community-based cancer patient navigator program will be modified in partnership with the     community into a multi-level screening intervention.   "
19435|NCT03031158|"     Low back pain (LBP) is extremely common in older adults and is associated with a host of     negative consequences, including decreased physical function and increased healthcare     utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are     more prevalent and associated with greater disability than among older adults without LBP.     This study will investigate a novel intervention designed to improve LBP-related disability     by combining a typical spine-focused exercise program with a hip-focused intervention.   "
19436|NCT03031145|"     The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation     following nasal application of felis domesticus, or cat, extract in e-cigarette users,     cigarette smokers, and non-smokers.   "
19437|NCT03031132|"     The purpose of this study is to examine the effects of breakfast skipping (SKIP) vs. the     consumption of a high protein solid (HP-S) breakfast vs. the consumption of a high protein     beverage (HP-B) breakfast on daily appetite control, food cravings, food intake, and sleep     quality in young adults.   "
19438|NCT03031119|"     Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for     14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919     co-administration at low and high doses on the PK of atorvastatin in a single cohort.   "
19439|NCT03031106|"     The aim of this study is to adjust and test an existing internet-based tool for collecting     patient-reported outcome measures and to use the internet-based tool in an multidisciplinary     follow-up of patients treated for malignant hematological diseases. The patient-reported     outcome measurements will be used in describing the patients' health-related quality of life     (HRQoL) and to investigate whether the HRQol will increase due to participation in     multidisciplinary follow-up.   "
19440|NCT03031093|"     This study has the objective to clarify the factors that directly influence the effectiveness     of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease     (COPD) and suggest the use of epap valve during their inhalation therapy.   "
19441|NCT03031080|"     The BOND study is a prospective, randomised single blinded controlled trial to assess the     effect of night splinting in patients who have had collagenase injection and manipulation     therapy for Dupuytren's Contracture.   "
19443|NCT03031054|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Rather than other progressive     disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease     the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved     to decrease adhension of soft tissue and nerve during operation. The investigators design a     randomized, double-blind, controlled trial to assess the effect after ultrasound-guided     hydrodissection with hyaluronic acid in patients with CTS.   "
19444|NCT03031041|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Rather than other progressive     disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease     the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively     used in clinical practice, current researches contain small participant without control group     or randomized leading to foreseeable selection bias. The investigators design a randomized,     double-blind, controlled trial to assess the effect of different method of ultrasound-guided     hydrodissection in patients with CTS.   "
19449|NCT03030976|"     CAR-T therapy was therefore proposed and has been recently used for cancer treatment. It has     been hailed for its promising remission rates after early stage clinical trials for acute     lymphoblastic leukemia. However, CAR-T therapy is seldom used for autoimmune diseases.     Researchers only use it for the treatment of multiple sclerosis (MS, an autoimmune disease of     the central nervous system). SLE is a kind of autoimmune diseases which involving multiple     systems, organs and with the present of a variety of autoantibodies. In the conventional     treatment options, SLE could be treated with chemotherapy drugs or hormone drugs. But     chemotherapy and hormone drugs could barely cured SLE. And now, chimeric antigen receptor     modified T cell infusion maybe an effective treatment to solve these problems. The     investigators use a 2nd CAR- T with the optimized hinge and transmembrane domain to treat     patients with SLE. The purpose of this study is to assess the safety and efficacy of this 2nd     CAR-T cells in the treatment of SLE.   "
19450|NCT03030963|"     Ventilator mode change was associated with decrease in blood loss during posterior lumbar     interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose     of this study was to determine the effect of equal ratio ventilation (ERV), which sets the     I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood     loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due     to decrease in the PIP.   "
19451|NCT03030950|"     This study is designed to explore the effects of peri-neural dexmedetomidine on the duration     and motor sparing potentials of adductor canal block in adult patients undergoing     arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators     ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps     muscle strength to promote safe and early ambulation.   "
19452|NCT03030937|"     The purpose of this study is to determine whether apatinib plus irinotecan can improve     progression free survival compared with single irinotecan in patients with advanced gastric     cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.   "
19453|NCT03030924|"     This study is prospectively enrolling a cohort of adolescent patients who present to the     Emergency Department with acute suicidality.   "
19454|NCT03030911|"     The aim of this study is to compare the effect of dexmedetomidine on resting energy     expenditure in relation to the midazolam in critically ill patients using indirect     calorimetry   "
19455|NCT03030898|"     The idea of this work came during a carotid surgery, when we noticed a respiratory variation     of the right internal jugular vein. Also, because of the interest of evaluating the preload     dependence during an intervention or reanimation where it is difficult to access the other     monitoring methods . The aim of the study was to test the hypothesis that respiratory changes     in right internal jugular vein diameter are similar to respiratory changes in superior and     inferior vena cava in mechanically ventilated patients and therefore help to predict fluid     responsiveness.   "
19456|NCT03030885|"     The main purpose of this study to determine the safety of an experimental medicine called     131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by     the U.S. Food & Drug Administration (FDA).   "
19457|NCT03030872|"     The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion     Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS     (investigational device) to the Olea Sphere PACS with Perfusion and DWI Modules (predicate     device). Therefore, there will be several separate objectives depending on the type of     acquisition:   "
19458|NCT03030859|"     This randomized pilot clinical trial studies how well the self-care program works in head and     neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care     activities for managing chronic swelling and tough/tight tissues in the head and neck region.   "
19459|NCT03030846|"     The purpose of this study was to evaluate the effects of stabilization exercises on pain,     disability and pelvic floor muscles function in patients with lumbopelvic pain.   "
19461|NCT03030820|"     This will be a prospective study of cirrhotics and healthy controls comparing their oral     microbiota, endotoxemia and systemic inflammation at baseline and at 10 and 30 days after     clinically indicated systematic oral cleansing and interventions as well as 3-month and 6     month hospitalizations post-cleaning.   "
19462|NCT03030807|"     The investigation serves the identification of pulmonary hypertension (PH) among patients     with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data     from South America indicate that the prevalence of pre-capillary PH amongst patients with HP     is higher than 20%. There are no reliable data from Europe so far. According to the     investigators previous analysis, more than 400 HP patients have participated in pulmonary     rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg     (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is     to be invited to participate in the study.      A diagnostic algorithm will be applied in the clinical trial, in the case of clinical     suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the     determination of the prevalence of PH in patients with HP the investigators aim to assess the     reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.   "
19463|NCT03030794|"     This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS)     on Gulf War illness related headaches and pain.   "
19464|NCT03030781|"     Specific and objective guidelines for choosing endobronchial tube size for main-stem     intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size     for OLV are likely to increase the safety and success. The primary aims of this study were to     define the relationship between cricoid and mainstem bronchi (right and left) in children of     various ages and to determine the effects of age, height and weight.   "
39492|NCT02768701|"     This phase II, single-arm, multicenter study will evaluate pembrolizumab therapy in patients     with advanced triple-negative breast cancer (TNBC) who have received at least one prior line     of therapy.   "
19528|NCT03030209|"     Glucose homeostasis changes after distal pancreatectomy are not well understood. This study     aim to identify the incidence of and risk factors for, a change in glucose homeostasis in     patients who underwent distal pancreatic resection.   "
19465|NCT03030768|"     The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial     proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships.     Such couples face a difficult dilemma when considering their desire to have children: forego     condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and     relinquish their childbearing desires. Based on evidence from rigorous clinical trials     demonstrating the strong efficacy of individual interventions for HIV-1 prevention and     formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1     prevention and reproductive health in the Kenyan context, this study pilots a safer     conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART]     taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1     uninfected partner) and timed condomless sex. Additional strategies for couples include     diagnosis and treatment of STIs and male circumcision.      mHealth tools, including SMS and mobile applications are novel and very popular among Kenyans     to ease the burden of addressing health problems. This safer conception intervention     incorporates mHealth tools to improve couples' experiences tracking fertility indicators and     communicating with providers about their readiness to practice safer conception. SMS surveys     to collect daily information from women about their fertility signs and SMS messages are used     to reinforce HIV-1 prevention, including condom use for couples during periods that do not     have a high likelihood of fertility. An in-clinic mobile application is used to improve     clinician-patient counseling and assessments of couple readiness to practice safer     conception. To inform future engagement of mHealth tools, the investigators will     prospectively evaluate clinician and patient experiences using SMS surveys and the tablet     application. Couples with immediate fertility intentions will be followed longitudinally,     allowing careful tracking of pregnancy and HIV-1 incidence. The study takes place in Thika,     Kenya.   "
19466|NCT03030755|"     The goal of this research is to develop measurement tools and simulation technology for     characterizing and predicting individual responses to corneal treatments and for advancing     understanding of corneal ectasia risk factors. Patients who either 1) have keratoconus and     are being evaluated for corneal crosslinking or 2) have refractive error and are being     evaluated for refractive surgery procedures such as LASIK will have their eyes imaged to     assess their mechanical properties and will have computational simulations performed to     predict the response to treatment. One aim of the study is to test the hypothesis that     computational models can predict the cornea's shape changes within clinically acceptable     limits of error.   "
19467|NCT03030742|"     This study seeks to investigate the prescribing patterns and patient utilization of opioid     pain medication in the postpartum setting. Postpartum women will be surveyed prior to     hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid     tablets they used (in relation to the number prescribed), pain satisfaction, and     storage/disposal of any remaining opioid tablets.   "
19468|NCT03029767|"     Hypertension is the most common risk factor for development of stroke, congestive heart     failure chronic kidney disease, and coronary artery disease in Sub Saharan Africa. The     prevalence of hypertension will increase by 2025 in most parts of the world including     Ethiopia according to World Health Organization.      Physical inactivity has been identified as a stronger predictor of chronic diseases such as     hypertension. Exercise as a lifestyle modification is beneficial to a wide variety of health     conditions, specific to hypertension; the benefits of exercise have been promoted by a number     of organizations and agencies including World Health Organization.      According to the knowledge of the investigator there are no research works in relation to     aerobic and resistance exercise effects among hypertensive patients generally in Ethiopia,     and particularly in the area selected for the present research. Therefore the aim of this     study is to assess the effect of aerobic and resistance exercises on selected anthropometric,     biochemical and physiological variables among hypertensive patients in Hawassa University     Referral Hospital.   "
19469|NCT03029754|"     The investigators wish to determine whether passive leg raise allows for easier peripheral     vascular access in the pediatric population. The investigators hypothesize that pediatric     anesthesiologists will have higher rates of successful intravenous catheterization in     children where a passive leg raise is employed.   "
19470|NCT03029741|"     The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque     psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin     covered with silvery scales. It occurs when skin cells are replaced more quickly than usual.     The seriousness of psoriasis varies greatly from person to person. For some people it is a     minor irritation, but for others it can have a major impact on their quality of life. .      The purpose of the study is to determine how much of AZD0284 is taken up by the body. The     safety and tolerability of the drug will also be assessed. It is hoped that the study drug     will improve the management of psoriasis.   "
19471|NCT03029728|"     Development of a new mass spectrometry based biomarker for the early and sensitive diagnosis     of hereditary angioedema disease type 1 from plasma   "
19472|NCT03029715|"     Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous     anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is     still unclear which anaesthesia regimen is better for this group of patients. The present     study was carried out to compare the use of inhalation anaesthesia technique using desflurane     and TIVA using propofol and dexmedetomidine.      Methods: This randomized controlled trial was carried out on 100 morbidly obese patients     undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal     groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received     general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation     group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group     anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion.     Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative     nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and     post-anaesthetic care unit (PACU) stay were studied for both groups.   "
19483|NCT03029572|"     An intervention study design in 90 obese patients will be used. Nutritional, metabolic and     psychological status as well as gut microbiota will be evaluated before gastric bypass and 6     months post surgery. During this period of 6 months, all patients will receive a specific     diet according to recommendation with regard to bariatric surgery.      Subjects will be than randomized in 2 sub-groups:      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.     patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin     and mineral supplementation   "
19493|NCT03030664|"     A randomized, multicenter, placebo-controlled, double blind study in two parallel groups     testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938     compared to placebo in increasing the number of spontaneous bowel movements in infants and     children with functional constipation.   "
19473|NCT03029702|"     Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over     400,000 pregnant women in the United States each year. Without adequate treatment, women with     GDM and their infants are at risk for substantial morbidity. Because of this, experts     recommend treatment focused on normalization of hyperglycemia to improve outcomes. However,     providers have limited capacity to predict which treatment will achieve glycemic goals. This     results in a choice based on provider and patient preference and a trial and error approach,     which can create delays in glycemic control within the short (8-10 weeks) window between     diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between     glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM     is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit     (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of     hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use     of an individualized treatment approach. The overall goal of this project is to investigate     an individualized treatment approach for GDM where treatment is based on each woman's GDM     mechanism. The study will employ the same treatment in both arms, but choice of treatment     will differ based on study arm (matched or unmatched to GDM mechanism).   "
19474|NCT03029689|"     The project presented here will be the first prospective, randomized evaluation of the effect     of ART on the structure and function of the gut microbiome. This study provides a unique     opportunity to understand the benefits of ART with high intestinal penetration on the gut     microbiome. It is thus a key study to understand the bidirectional interactions between the     microbiome and the host in people living with HIV/AIDS.   "
19475|NCT03029676|"     This study evaluates the influence of premedication on cognitive functions in patients     undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of     premedication are anxiolysis, analgesia and the reduction of perioperative risk among the     patients with comorbidities. The patients will be randomly allocated to receive premedication     either with opioid solely or with benzodiazepine combined with opioid. The anesthetic     technique is standardized.   "
19476|NCT03029663|"     This is a prospective study enrolling consecutive patients who undergo transurethral     resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure.     Study end-points are incidence, severity and predictive factors of surgical complications.     The study secondary aim is a validation of Clavien Dindo scoring system for reporting     complication of TURBT.   "
19477|NCT03029650|"     The study to be performed will utilize already FDA-approved marketed products in healthy     adults for the purpose to generate data for establishing rate of drug delivery of Transderm     Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of     individuals utilizing these types of products.   "
19478|NCT03029637|"     Tooth replacement is a significant issue in the World. Such replacement is considered     important by patients to improve aesthetics, function and quality of life. Tooth replacement     is therefore a significant issue. Resin-bonded bridges (RBBs) are conservative and     cost-effective tooth replacement option that involves minimal tooth preparation and are     secured in place with an adhesive cement by bonding to the outer enamel layer of the tooth.     Clinical reports of these prostheses at the University of Hong Kong shows some of the highest     success rate and greatest longevity in the dental literature. However, a problem with this     type of prosthesis in that it still needs some tooth preparation to accommodate the framework     thickness of the bridge. In some patients with tooth wear, this may mean cutting through the     enamel crown down into dentine which will weaken the tooth. In light of the tooth preparation     some patients will refuse this treatment, in particular patients with dental drill phobias.      The aim of this study is to investigate RBBs with tooth preparation and with no tooth     preparation for the replacement of single missing teeth in a randomized controlled trial.     However, a significant consequence of a no preparation RBB will mean that after cementation     the prosthesis will interfere with the patient's bite, making the bridge prosthesis stand     high. This will take time for the patient's original occlusion to re-establish itself by the     movement of the tooth supporting the bridge. Despite the success of supra-occluding     restoration has been reported in some studies, currently neither no preparation nor     supraoccluding dental bridges are the standard of care for general dental practitioners and     have not been reported on as a clinical trial in the literature. Most symptoms reported for     supraoccluding restorations were transient and are reversible. The findings of this research     will have significant impact on the teaching and practice for clinical prosthodontics and     patient care worldwide. Patients will have a dental prosthesis that requires no dental     drilling, no local anaesthetic and will have a stronger tooth supporting the bridge that     should have greater longevity. More patients, in particular phobic patients will therefore     seek treatment for tooth replacement with this conservative treatment option.   "
19479|NCT03029624|"     The study is a single arm, prospective study of the safety and effectiveness of the Valencia     Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with     refractory urgency urinary incontinence.   "
19481|NCT03029598|"     This phase I/II trial studies how well pembrolizumab and carboplatin work in treating     patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back or has     not responded to previous treatment. Monoclonal antibodies, such as pembrolizumab, may     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,     such as carboplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     pembrolizumab and carboplatin may work better in treating patients with ovarian, fallopian     tube, or primary peritoneal cancer.   "
19482|NCT03029585|"     This study will evaluate NanoPac® administered intraperitoneally (IP) immediately     post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy,     in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with     SOC IV chemotherapy alone.   "
19492|NCT03030677|"     The investigators are trying to establish an easy technique for insertion of a catheter for     continuous infusion while performing pectoral type 2 (serratus) block, as a post operative     pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence   "
19484|NCT03029559|"     Rehabilitation approaches introduce a stimulus to a motor system, with the goal to enhance     motor function to patients. For example, exposure to brief and intermittent episodes of mild     hypoxia has shown to strengthen synaptic pathways to respiratory and skeletal muscle motor     neurons. In humans with spinal cord injury, exposure to intermittent hypoxia (IH) alone or in     combination with rehabilitative strategies has shown enhanced motor function. Another     strategy known as inspiratory threshold loading, which involves breathing against pressure     threshold loads, results in improved inspiratory muscle strength. Although there is evidence     supporting the use of IH alone or in combination with other rehabilitative strategies in     improving motor function in humans, the impact of exposure to IH or IH with inspiratory     threshold loading on inspiratory muscle function and ventilation in humans is unknown.   "
19569|NCT03029416|"     30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic     outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the     radiation oncologist) with respect to disease control and toxicity.   "
19485|NCT03029546|"     The investigator's main objective is to analyze the effects of a routine prenatal care     screening tool (glucola test for gestational diabetes) on maternal inflammation through     assessment of maternal circulatory biomarkers and blood pressure. Improving knowledge about     routine prenatal care and how a variety of screening factors affect maternal physiology     allows the investigators to be educated and informed when caring for mothers with medical     co-morbidities.        -  Determine if an acute glucose load (50g) is associated with an in-vivo and in-vitro          increase in the concentration of Advanced Glycation End Products (AGEP's) that, in turn,          can impact vascular endothelial reactivity and induce an acute increase in blood          pressure. Previous studies generated in the investigators' laboratory showed that          circulating soluble Receptor for Advanced Glycation End Products (sRAGE) and Tumor          Necrosis Factor (TNF)-a (mediator of acute inflammation) are considered markers of the          extent of maternal RAGE activation and/or systemic inflammation, respectively.        -  Determine how an acute glucose load (50g) at the time of normal screening for          gestational diabetes induces an acute increase in the level of sRAGE and TNF-a. If the          investigators' hypothesis is confirmed, the investigators will have strong confirmation          of the involvement of glycation products and TNF-a in generating the acute negative          clinical symptoms of women experiencing a glucose tolerance test, such as headache,          nausea, sweating, and bloating.   "
19486|NCT03029533|"     The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of     DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with     prostate cancer   "
19487|NCT03029520|"     The aim of this study was to evaluate and compare postoperative pain and overextension of     root canal filling after root canal treatment using a carrier-based obturation system and two     different sealers.      In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160     patients were treated. Patients with vital and devital teeth were assigned to four groups     using a randomized block design with block sizes of 10 patients each. The groups were     composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth     treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus     sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator     prepared root canals and filled them with sealer using the carrier-based obturation     technique. Radiographs were taken and obturation length was recorded. Patients recorded pain     scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6,     6-12, 12-24, and 24-72 h..   "
19488|NCT03030729|"     Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a     commercial OCT (Optical Coherence Tomography)   "
19489|NCT03030716|"     Tannins are known to inhibit iron absorption through formation of insoluble tannin-mineral     complexes, and have thus been termed 'antinutritional.' Despite this, there is evidence that     adaptation to similar antinutritional factors is possible when consumed over time.     Limitations in current studies include short (single meal) duration, and use of incongruent     tannin types from the condensed tannins that are commonly consumed. If adaptation to tannins     does happen, it may be due to salivary proline-rich proteins, which have been found to be     protective of iron status in animal models. The primary objectives of this study are: 1) To     determine whether condensed tannins impact iron bioavailability or status when consumed in     multi-dose, multiple daily supplements and 2) to test whether salivary protein production may     impact iron bioavailability with tannin supplementation. Secondary objectives included     assessment of the reliability of astringency as a measure of salivary protein production and     iron absorption.      The study has been conducted in an iron absorption study of 11 women, aged 18-35 years old,     to determine iron bioavailability with supplementation of 0.03, 0.25, and 1.5 g 95%     proanthocyanidin rich grape seed extract before and after regular, three times daily     supplementation for four weeks. Each participant consumed all three concentrations of     supplement over the 26-week study, with a two-week washout between interventions. Direct iron     absorption was measured using area under the curve. Iron status was measured by changes in     hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. Salivary     samples were collected before and after supplement consumption during meal challenges, and     analyzed on HPLC. Astringency testing was conducted at the end of each meal challenge. Iron     absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise     comparison by least significant differences. Pearson's correlations were used to correlated     salivary proteins and astringency with iron bioavailability.      The present study will provide important information regarding the approximate influence of     condensed tannin consumption on iron bioavailability and storage over time, at different     doses. Data will also help to delineate possible physiological mechanisms underlying tannin     adaptation and possible ways to detect individuals who better adapt than others.   "
19490|NCT03030703|"     Phytic acid is a known inhibitor of iron bioavailability, although long term studies have     suggested possibly exaggerated findings compared to single meal studies, pointing to phytic     acid adaptation over time. Salivary proline-rich proteins have been found to reduce     tannin-iron chelation, but studies have not explored changes in salivary proteins that may     result in phytic acid adaptation. The primary objectives of this study are: 1) To determine     whether phytic acid impacts iron bioavailability or status when consumed over time 2) to test     whether salivary protein production may impact iron bioavailability with phytic acid     supplementation, and 3) to explore in vitro phytic acid salivary binding. Secondary     objectives included assessment of the reliability of astringency as a measure of salivary     protein production and iron absorption.      The study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to     determine iron bioavailability with supplementation of 350 mg phytic acid before and after     regular, three times daily supplementation for four weeks. Direct iron absorption was     measured using area under the curve. Iron status was measured by changes in hemoglobin and     ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were     collected before and after supplement consumption during meal challenges, and analyzed on     HPLC and by ELISA. Astringency testing was conducted at the end of each meal challenge. In     vitro saliva-phytic acid modeling was explored on HPLC, MALDI-TOF, and ELISA. Iron absorption     and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison     by least significant differences. Pearson's correlations were used to correlated salivary     proteins and astringency with iron bioavailability.      The present study will provide important information regarding the approximate influence of     phytic acid consumption on iron bioavailability and storage over time in regards to salivary     proteins. It will also give context to the role of salivary proteins with phytic acid     consumption over time. Data will also help to delineate possible physiological mechanisms     underlying phytic acid adaptation and possible ways to detect individuals who better adapt     than others.   "
19491|NCT03030690|"     This study will evaluate the clinical performance of glass carbomer cement restorations in     restoring proximal lesions in primary molars compared to that of resin modified glass ionomer     cement and composite resin restorations. Teeth will be randomly assigned to one of the three     restoration groups and the restorations will be evaluated clinically and radiographically     every six months.   "
19494|NCT03030651|"     The purpose of this study is to develop and test Breastfeeding Education and Support     Intervention for improving timely initiation and Exclusive Breastfeeding rate.      Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the     simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does     not meet the international recommendation for exclusive breastfeeding (EBF) for the first six     months of life. Community-based educational and support interventions provided prenatally and     postnatally are effective in increasing BF rates. However, there is paucity of such     information in Ethiopia.   "
19495|NCT03030638|"     This study aims to characterise the use of single-agent olodaterol and single-agent     indacaterol, the only marketed LABAs authorised for COPD, but not for asthma, in clinical     practice.   "
19496|NCT03030625|"     The aim of this study was to determine the efficacy and safety of the implementation of a     program of  image-guided focal Intensification dose to intraprostatic dominant lesion  in     men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN)     eligible to receive radiotherapy in the Department of Radiation Oncology of HUP within the     established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT     / IGRT).   "
19497|NCT03030612|"     The purpose of this Phase I/II study is to investigate the safety and tolerability (Phase I)     and the efficacy/clinical benefits (Phase II, proof-of-concept) of ARGX-110 in combination     with standard doses of azacytidine (AZA) in subjects with previously untreated acute myeloid     leukemia (AML) or high risk myelodysplastic syndrome (MDS) who are eligible for AZA     treatment.   "
19499|NCT03030586|"     The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance     of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease.      ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance     study with only one visit.      About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely     patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD)     and 200 control subjects (healthy as compared to their age).        -  400 patients with Alzheimer's disease (AD),        -  200 patients with non-Alzheimer's neurodegenerative diseases (NAD),        -  200 controls (healthy as compared to their age).   "
19500|NCT03030573|"     The investigators developed a new surgical technique in order to reconstruct the bile duct     with the round ligament   "
19501|NCT03030560|"     The purpose of this study is to evaluate the effect of intraoperative use of lidocaine     intravenous infusion on the postoperative analgesic consumption after adult spine surgery.   "
19502|NCT03030547|"     To evaluate physical activity levels and factors associated with physical activity levels in     adult patients with muscle diseases.   "
19503|NCT03030534|"     The purpose of this study is to adopt an operational research approach that seeks to design,     develop and pilot-test the health-promotion lifestyle model that will enhance     health-promoting behaviour and lifestyle modification of university staff in Nigeria. The     following are the hypotheses of the study:        1. There will be a significant difference in the pre and post intervention practices of          health promoting lifestyle behaviours (behaviour specific cognition and affect) of NOUN          staff        2. There will be significant association between the health promoting lifestyle behaviours          (behavioural outcome) and health status of NOUN staff        3. There will be a significant difference in the pre-and post-intervention health promoting          lifestyle behaviours (behavioural outcome) of staff of NOUN        4. There will be a significant difference in the pre-and post-intervention health status          measure (specific health measurement indicators) of staff of NOUN   "
19504|NCT03030521|"     Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why     some aortic dissection are limited in extent while other aortic dissection extend     extensively. The investigators hypothesize that the medial layers are separated as a result     of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis     is ture, dilation is necessary to the development of aortic dissection. In this study, an in     vitro experiment was performed to test whether dilation is essential to the development of     aortic dissection.      Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart     Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation.     Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly,     the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner     surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue     sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of     the experimental group was bound by a band to restrict its dilation in the next step.     Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly,     for the experimental group, the band is removed, and the syringe is filled with red stain.     The mechanical test is performed again. Finally, the tissue sheet is released and cut into     several parts to show whether the inner and outer media layers are separated by the blue     stain or the red stain.   "
19505|NCT03030508|"     At present, chemotherapy is widely used in the adjuvant treatment of colorectal cancer     patients after surgery. Capecitabine is one of the main chemotherapeutic drugs. But the     effect is not good enough, the adverse reaction is serious, and the individual differences     were significant. The present study shows that these problems are related to the differences     in the exposure of capecitabine and its metabolites in different patients. The genetic     biomarkers for capecitabine include DRD, MTHFR and TYMS. Mutations in these genes directly     affect the expression of metabolic enzymes involved in capecitabine and control the     concentration of capecitabine and its metabolites. However, these markers have been obtained     through clinical trials in the United States, and their role in predicting the effectiveness     or safety of capecitabine and its metabolites has not been validated in Chinese cancer     patients.The study was based on a case study of patients with colorectal cancer in China, and     capecitabine as the primary postoperative chemotherapy regimen to verify whether the     available biomarkers can be used to predict the effectiveness and safety of capecitabine. To     clarify the effect of capecitabine on endogenous metabolites, and to study the mechanism of     its effect, so as to discover new biomarkers.   "
19506|NCT03030495|"     1. To compare the risk of atherosclerotic lesion progression and subsequent          patient-oriented composite outcomes (all-cause mortality, any MI, or any Ischemia-driven          repeat revascularization) between deferred lesions with or without over microvascular          disease, defined as physiological classification        2. To explore independent predictors of atherosclerotic lesion progression in deferred          lesions based on fractional flow reserve-guided strategy and treated by contemporary          medical treatment   "
19507|NCT03030482|"     Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its     occurrence can be related to several causes, mainly dominated by invasive procedures.      anxiety management is typically based on a combination of prevention, evaluation, and     therapeutic agents. However, it appears important to develop adjuvant approaches. Touch     massage is one of them and that has been evaluated in various medical conditions.      The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill     patients during potentially painful nursing procedures.   "
19509|NCT03030456|"     This study is a randomized clinical trial that has as objective to evaluate the effects of     training with a vibratory platform on body composition, muscular strength functional     capacity, flexibility and biochemical profile on elderly women. It will be done in the city     of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80     years-old, within the municipal limits and nearby areas selected randomly by a brown envelope     in which a note will be stating if they belong to the control or vibratory platform group, in     which the participant will be receiving whole body vibrations on the platform. The recruiting     will be done by the institution through e-mail or by public call.      Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied,     in order to evaluate if they don´t have counterindications for the vibratory platform. They     will be evaluated in their general health, socio-economical status, and history of physical     activity. Participants will have their doubts cleared about the study, and a written consent     will be signed. Before the intervention with whole body vibrations, nutritional and physical     activity aspects will be evaluated. The treatment period on the vibratory platform will be of     8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility, palmar     prehension strength, metabolic basal load, and functional capacity measurements will be     taken. Before and after every session on the vibratory platform, heart rate, respiratory     rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The     interventional procedure will be done with a vibratory platform (Power Plate®, model my7™,     UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will     last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training,     and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee     flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the     amplitude of 2 mm.      The study aims to contribute with reducing the body mass index and body fat percentage, to     improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and     flexibility, also obtaining better biochemical profiles after the training period.   "
19510|NCT03030443|"     This study will use semi-structured interviews with participants in a prospective cohort     study to explore women's experiences of pain and preferences in pain management during first     trimester surgical abortion to create a more patient centered experience. We will analyze two     study cohorts of women undergoing first trimester surgical abortion: women choosing oral     anesthesia and women choosing nitrous oxide.   "
19511|NCT03030430|"     The purpose of this study is to establish PK similarity in the treatment of BAT1706 and     comparators.   "
19512|NCT03030417|"     Background:      The new drug LMP744 damages DNA. This causes cell death. Researchers want to see if it can     treat certain kinds of cancer. They want to understand how the drug works and how it affects     the body.      Objective:      To test the safety of LMP744 and find out the dose of the drug that can be safely given to     humans.      Eligibility:      Adults at least 18 years old who have metastatic solid tumors or lymphoma, which have     progressed after other treatment.      Design:      Participants will be screened with:        -  Vital signs taken        -  Blood and urine tests        -  Heart tests        -  Scans or ultrasound      Some participants will have a tumor sample taken 2 times. A small piece of tumor is removed     by a small needle. A scan or ultrasound will guide the process.      The study will be done in 28-day cycles.      Each cycle, participants will get the study drug in a vein for 60 minutes once a day for 5     days.      For day 1 of cycle 1, participants will be admitted to the clinic and have blood and urine     taken several times.      At the beginning of each cycle, participants will have a clinic visit and repeat some     screening tests. They will also do this twice in the middle of cycle 1 and once in the middle     of cycle 2.      After participants stop taking the study drug, they will be followed for 30 days. They may     give blood samples. They will be contacted by phone to see how they are doing.   "
19513|NCT03030404|"     Background:      Gastric cancers are cancers of the stomach. Hereditary ones are passed from parent to child.     Researchers want to gather data about hereditary gastric cancers. They want to learn about     changes these cause in the body and about the genes involved.      Objective:      -To gather data about hereditary gastric cancer.      Eligibility:        -  People at least 2 years old with personal or family history with a hereditary gastric          cancer.        -  People at least 2 years old with gene changes that lead to such cancer or a lesion that          may be hereditary.      Design:        -  Participants will be screened in a separate protocol.        -  Participants will have:             -  Physical exam             -  Medical history             -  Blood tests             -  Scans             -  Photos of skin lesions and other findings             -  Gynecology consultation for women             -  Cheek swab (some participants)        -  For some participants, their relatives will be asked to join the study.        -  Some participants will be asked to allow the study to get stored tissue samples for          relatives who have died.        -  Some samples will be sent to outside labs. All personal data will be protected. Samples          will be destroyed when the study ends.        -  Participants will get the results of genetic testing.        -  Participants who cannot come to the NIH clinic may just give a cheek swab and have          genetic testing done.        -  Some participants will be contacted for more testing.   "
19596|NCT03029065|"     This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and     to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment     efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring     tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.   "
19514|NCT03030391|"     Background:      The new drug 18F-PF-06445974 has a little radioactivity. This can be seen by a positron     emission tomography (PET) scan. The drug helps researchers see a protein, PDE4B, in the     brain. Looking at PDE4B in the living brain might show how it is involved in psychiatric and     neurological disorders. One part of the study will look at how the study drug is distributed     in the brain. Another part will study how brain measures vary.      Objectives:      To measure the protein PDE4B in the brain. To test how a new radioactive chemical,     18F-PF-06445974, is distributed in the body.      Eligibility:      Healthy adults ages 18 and older      Design:      Participants will have 1-3 visits over a year. Each will be 2-5 hours.      Women will have a pregnancy test each time.   "
19515|NCT03030378|"     This phase I trial studies the side effects and best dose of pembrolizumab and recombinant     interleukin-12 in treating patients with solid tumors. Monoclonal antibodies, such as     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Recombinant     interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating     white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12     may work better in treating patients with solid tumors.   "
19516|NCT03030365|"     Despite the high prevalence of Alzheimer's disease (AD), its underlying mechanisms remain     poorly understood. An emerging body of evidence supports disorientation as an early marker     for AD-related neurodegeneration. In this study we intend to collect, coregister and analyze     Positron Emission Tomography (PET) and , functional and structural magnetic resonance imaging     (MRI, fMRI) data from AD-spectrum patients to establish orientation as core disturbance in     AD.   "
19517|NCT03030352|"     The objectives of the How-to parenting program are 1) to improve optimal parenting style, and     2) to foster children mental health (i.e. decrease in internalized and externalized problems,     and well-being). The investigators expect that parents assigned to experimental groups will     show improvements in parenting over time (i.e improvements in parental affiliation, parental     structure and parental attitude toward autonomy), whereas parents in control groups will not     show such improvements (i.e., stable or declining parenting quality). The investigators also     expect children of parents in experimental groups to experience improvements in child mental     health (i.e., fewer internalized and externalized psychological problems and increased     well-being), whereas children whose parents are on the wait list will not show improvements     over time (i.e., stable or deteriorating mental health and well-being).   "
19518|NCT03030339|"     The goal of this study is to assess whether children 12-18 months of age who are exposed to     multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above     the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers     of excessive vitamin A status, compared to children 12-18 months of age who have adequate     vitamin A intake.   "
19519|NCT03030326|"     Twenty patients with a history of treatment, within the past year, of both asthma and either     depression or an anxiety disorder will be recruited for this study. Patients will be     recruited from their doctors and from advertisements. The investigators will randomly assign     patients to two groups, using a crossover design. One group will first receive three months     with four biweekly sessions of heart rate variability biofeedback treatment, and then will be     followed for three months with a daily symptom diary. The other group will first be followed     for three months, and then given the three months of treatment. In both treatment and     following procedures, patients will receive psychophysiological testing sessions at the     beginning and end of the three month period. The investigators will assess symptoms of     asthma, anxiety, and depression as well as pulmonary function and will measure heart rate     (from electrodes on the wrists), respiration (through a belt around the waist), end tidal     carbon dioxide (through a cannula in the nose).   "
19520|NCT03030313|"     Assess the feasibility of using remote respiration rate monitoring as a component of home     care, how respiration rate data may be used in combination with other data to potentially     improve response to symptoms, and to generate data to inform the endpoints and effect sizes     of future studies.   "
19521|NCT03030300|"     To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in     newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to     the remission rate.   "
19522|NCT03030287|"     The purpose of this study is to test the efficacy and safety of an experimental drug,     OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal     antibody and was developed to target cancer stem cells. Based on preclinical studies, it is     believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the     productive growth of new blood vessels, which tumors need to grow and spread.   "
19523|NCT03030274|"     This study aims to investigate safety and efficacy of the Occlutech® AFR device in patients     with HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with     preserved ejection fraction)   "
19524|NCT03030261|"     Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for     multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT,     the natural next step is to evaluate maintenance/continuation therapy following second ASCT.      Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide,     making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab     may increase efficacy and also the durability of responses which is essential to improving     outcomes following second ASCT.   "
19535|NCT03030118|"     This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial     that is designed to test whether treating patients who are at risk for development of lupus     with hydroxychloroquine can slow accumulation of disease features. Effects on clinical     progression of symptoms, patient-reported outcomes and changes in the immune markers of     response will be measured and toxicity of the treatment will be assessed. This trial is a     first step in testing a prevention strategy for lupus.   "
19536|NCT03030105|"     This is a Phase 1, randomized, double-blind, placebo-controlled, 6-period crossover study to     evaluate the effects of BPN14770 10 mg and 50 mg in reversing scopolamine-induced cognitive     impairment in healthy volunteers. A positive control, donepezil 10 mg, will be included, and     additivity of BPN14770 50 mg to donepezil 10 mg in reversing scopolamine effects will also be     evaluated.   "
19525|NCT03030248|"     There is good evidence that randomizing C. difficile NAAT(+), toxin(-) patients to     non-treatment represents an ethically tolerable risk-benefit, even in cancer patients and     hematopoetic stem cell transplant (HSCT) recipients. Actually, detection of free toxin in the     stool was the standard of care for the diagnosis of C. difficile infection (CDI) from 1983     through 2010. Since then, NAAT became the standard diagnostic test for over 60% of US     hospitals (National Healthcare Safety Network, unpublished data). However, there is growing     evidence that symptomatic patients who are NAAT(+), toxin(-) have outcomes similar to     patients who are NAAT(-), toxin(-); some of these outcomes include 30-day mortality, ICU     admission, and hospital readmission triggered by C. difficile. Furthermore, the United     Kingdom has successfully used a similar two step diagnostic algorithm with a confirmatory     toxin EIA since 2012.      The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-)     patients may be particularly important in transplant recipients. The usual treatment     prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While this     drug has excellent activity against C. difficile and commonly suppresses its growth to     non-detection, it does not eradicate carriage and its use results in marked and prolonged     disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal     microbiota disruption at the time of HSCT engraftment has been demonstrated to be an     independent predictor (controlling for other markers of underlying disease) of overall and     transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow     suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin     (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All     these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile     patients might have significant negative repercussions without a clear clinical benefit.   "
19526|NCT03030235|"     The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared     with placebo, on heart failure, disease specific biomarkers, symptoms, health status and     quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure     with preserved systolic function.   "
22456|NCT02991690|"     This study is a prospective multi-center trial designed to determine the safety profile and     efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8)     Spinal Cord Injury (SCI).   "
19531|NCT03030170|"     Despite an improvement regarding morbidity and mortality since 30 years, especially in expert     centers, pancreatic surgery remains currently associated to a significant postoperative     morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication     following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be     able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital     stays. The main risk factors associated to the occurrence of pancreatic fistula are     represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of     the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of     pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue.     Currently, no formal recommendations concerning the optimal technical for closure of the     distal stump in DP are available. In fact, manual closing by elective suturing or stapling of     the main pancreatic duct give similar results. The use of a reinforcing stapling potentially     represents a simple way to decrease the occurrence of pancreatic fistula and requires     evaluation by a prospective randomized study.   "
19532|NCT03030157|"     Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy     for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection,     which is associated with costs of treatment and potential poor prognosis. Although several     randomized controlled trial have shown that prophylactic intravesical chemotherapy could     prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown.     The investigators want to determine the efficiacy of single instillation versus long-term     intravesical instillation of pirarubicin for bladder recurrence after radical     nephrouretectomy for primary upper tract urothelial carcinoma.   "
19533|NCT03030144|"     The international literature emphasizes the vast benefits of the effective implementation of     evidence based nursing recommendations in improving patient care processes and enhancing     health outcomes. The key role of nurses in the prevention, treatment and care of incontinence     is highlighted. Studies have shown that UI is a neglected nursing care problem in Austria     e.g. regarding diagnosis and nursing interventions. Nursing recommendations may enhance the     frequency of diagnosis, the use of nursing interventions as well as decrease the frequency of     daily UI in nursing home residents. Beside that little is known about nursing recommendations     implementation regarding urinary incontinence in the nursing home setting, especially in the     Austrian context.      The aim of this study is to measure the effectiveness of the implementation of evidence based     nursing recommendations regarding UI in Austrian nursing homes.   "
19534|NCT03030131|"     Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall     all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA)     NSCLC is curative surgery. Although patients treated with curative surgery have a better     prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging     from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative     chemotherapy versus no chemotherapy have shown a significant overall survival benefit from     postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA.     Likewise other randomized trials have demonstrated preoperative chemotherapy improves     survival and recently the analyses also based on individual patients data of 15 randomized     trials showed a significant benefit of preoperative chemotherapy on survival with the same     survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become     accepted in many countries.      Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an     attractive therapeutic option in the early stage NSCLC, which may reactivate host immune     responses and enable longterm tumor control.   "
19537|NCT03030092|"     One group will receive today's standard rehabilitation program following hip fracture     surgery. The intervention group will have maximal strength training incorporated in their     program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over     4 sets for leg press and abduction resistance exercise at 85% of maximal strength is carried     out. Oxygen consumption of walking, muscle mass, strength, balance and bone density will be     compared between the groups following the 8-week rehabilitation period.   "
19538|NCT03030079|"     The goal of this pilot study is to assess the effectiveness of an electrical stimulation     therapy option for the treatment of chronic phantom limb pain in upper or lower limb     amputees. This therapy has been previously used for sports and joint injuries and is marketed     for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy,     increased local blood circulation, and maintaining or increasing range of motion. The     investigators would like to explore the idea that physically exercising the muscles of the     residual limb and increasing blood flow to the site of amputation through the promotion of     motor contraction using electrical stimulation decreases chronic phantom limb pain.   "
19539|NCT03030066|"     This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics     (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132     mutations.   "
19540|NCT03030053|"     A double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy     older adults will be conducted to determine the effect of a flavonoid-rich supplement on     cognitive function, peripheral arterial health and brain mechanisms. It is predicted that     chronic flavonoid supplementation will result in cognitive benefits and that these may be due     to beneficial effects of flavonoids on vascular and brain function.   "
19541|NCT03030040|"     This study examines whether a mindfulness-based self-help book is effective at reducing     healthcare workers' levels of stress and improving their wellbeing.   "
19542|NCT03030027|"     The purpose of the present study is to examine the effects of perspective-taking reappraisals     on the well-being of adult-child dementia caregivers.   "
19543|NCT03030014|"     assess the effect of dental educational program on oral hygiene among institutionalized     hearing impaired and mute children in Cairo, Egypt.   "
19544|NCT03030001|"     This is a single-arm, open-label, one center, dose escalation clinical study, to determine     the safety and efficacy of infusion of autologous T cells engineered to express immune     checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with     mesothelin positive, recurrent or refractory malignant tumors.   "
19545|NCT03029988|"     Estimation of the concordance of Tc 99m localization in liver metastases from colorectal     carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.   "
19546|NCT03029975|"     Humans lose muscle and strength as they get older. Further, ageing is accompanied by loss in     cognitive function. It is not quite clear why this happens; however, it is known that the     loss of muscle and strength can increase risk for physical and mental health risks and impair     the ability of older people to remain physically independent. Weight lifting and proper     nutrition, particularly eating high quality protein at the proper time and quantity, may help     prevent these losses when a person gets older. To determine if regular beef consumption as     part of a higher protein diet aids the muscle adaptive response to resistance training and     improvements in cognition, seventy healthy individuals will be recruited to lift weights 3     times a week for 10 weeks. One group (n=36) will consume the Recommended Dietary Allowance     (RDA) for protein (0.8g/kg/day), while the other group (n=36) will consume an amount twice     the RDA (1.6g/kg/day), which is in agreement with recommendations from the American College     of Sports Medicine. Participants will have their muscle strength tested and samples of blood     and muscles will be collected before and after training to determine how the muscle adaptive     response to resistance exercise is affected by higher protein intake. In addition,     participants will undergo cognitive assessments at baseline and follow-up to determine the     influence of improving muscle strength on attention and memory. Overall, the investigators     proposed study will use sensitive methodology to determine if providing protein above the RDA     and at optimal times during the day in combination with a weight lifting program can help     make someone stronger and build larger muscles than someone consuming the RDA, as well as     what processes may be responsible for helping the muscles to get bigger and stronger.   "
19547|NCT03029962|"     The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text     messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB     women ages 14-18 years, nation-wide. The guiding theoretical model is the     Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is     associated with increases in TPP behavior.   "
19548|NCT03029949|"     The purpose of this study is to examine the effectiveness of acceptance and commitment     therapy with vestibular rehabilitation in addition to clinical management for chronic     dizziness, in comparison with treatment-as-usual(TAU) which is self-treatment vestibular     rehabilitation in addition to clinical management for chronic dizziness.   "
19549|NCT03029936|"     Obesity and asthma share changes that may begin in the fetal development phase. The     endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory     response different from the habitual Th2 profile of cytokines. In these obese patients,     possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary     ventilation significantly.      Due to the importance of the diaphragm in pulmonary ventilation, this study will be performed     to verify possible alteration in the excursion and diaphragmatic thickness of adolescents     with endophenotype obesity-asthma. In parallel, the possible underlying etiopathogenic     substrate of this endophenotype will be explored through the dosing of muscle enzymes and     inflammatory cytokines and obesity hormones.   "
19590|NCT03029143|"     The purpose of this study is to investigate the effect of vedolizumab intravenous (IV) dose     optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen at     Week 30 in participants with ulcerative colitis (UC) and high vedolizumab clearance, based on     a Week 5 predefined serum vedolizumab concentration threshold (< 50 µg/mL) and who are Week 6     non-responders.   "
19610|NCT03028883|"     In this retrospective cohort study, we plan to examine the relationship between buprenorphine     dose adjustments, gestational age, urine buprenorphine levels and the rate of neonatal     abstinence syndrome in opioid-maintained pregnant women   "
19550|NCT03029923|"     Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However,     depression and smoking are highly co-morbid and depressed mood may interfere with cessation     and independently predicts mortality. Thus, a single, integrated treatment for both smoking     and depression could be highly effective in reducing post-acute coronary syndrome mortality.     Behavioral Activation (BA) is a well established treatment for depression and has recently     shown promise as a treatment for smoking cessation. The investigators systematically     developed an intervention integrating gold standard smoking cessation counseling with     existing BA based mood management techniques for post-ACS smokers; Behavioral Activation     Treatment for Cardiac Smokers (BAT-CS).      Objective: For this R56 the investigators will conduct a vanguard trial to pilot all methods,     materials, and systems for the later fully powered BAT-CS vs. attention control trial. The     investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS     or an attention control (Health and Wellness Education). Both groups will be offered the     nicotine patch if medically safe.   "
19551|NCT03029910|"     The purpose of this study is to determine the effectiveness of eccentric exercise combined     with vibration or cryotherapy in Achilles tendon pathology.      The investigators hypothesis is that the combined eccentric exercise is better than the     results presented by the exclusive eccentric exercise.      This intervention differs from the classic studies in that we maintain the intensity     throughout the treatment.   "
19552|NCT03029897|"     Adverse drug reactions are collected exhaustively during the experimental development phase     of the drug, but the trial population is not representative. In post-marketing authorization,     the use in the real life of medicines requires to specify the profile of adverse effects     through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug     reactions prevents a satisfactory knowledge of the risks. For example, in the multiple     sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported     by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera®     dimethyl-fumarate, while trials reported 39% of flush.      The investigators propose a study measuring the impact of the deployment of e-reporting to     patients in a population suffering from multiple sclerosis in initiation of first line drug     therapy. The study design will be a randomized controlled trial. Twenty-four direct or     indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without     intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal     neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5     patients, a total of 180 patients will be included. The expected duration of this study is 12     months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient.     At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be     made by telephone call to each patient.      The study is part of the pharmacovigilance system in place in France and aims to improve its     efficiency by increasing declarations and therefore earlier detection of signals in order to     prevent and minimize risks.      The comparison of the two arms should make it possible to decide on the usefulness of     national support for e-reporting, while respecting a good integration with the French     pharmacovigilance system.   "
22711|NCT02988336|"     The purpose of this study is to assess the usefulness of the Thyromental Height Test in     prediction of difficult intubation using double lumen endotracheal tubes in patients     scheduled for elective thoracic procedures.   "
19553|NCT03029884|"     This study evaluates invasive deep brain stimulation (DBS) in the treatment of chronic     neuropathic pain. Half of the participants will be assigned to a group with recording /     stimulation to one pain-related circuit of the brain while the other half of participants     will be assigned to recording / stimulation to a different pain-related circuit of the brain.     Relief of pain symptoms with stimulation will be studied in both groups. It is hypothesized     that neural signals will correlate with pain states and that DBS can disrupt these pain     states in both groups.   "
19554|NCT03029871|"     The primary objective of this phase 1 trial is to determine the dose-dependent toxicity and     maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic gene therapy in     combination with SBRT in medically inoperable stage I (T1b - T2a) NSCLC. To accomplish this     objective, 9 subjects will be enrolled in the study. We hypothesize that the combined     treatment will demonstrate acceptable toxicity, and that it will be feasible to quantify     adenovirus-mediated HSV-1 TK gene expression in the lung by PET. This phase 1 trial will lay     the foundation for a follow-up phase 2 trial designed to examine efficacy.   "
19555|NCT03029858|"     The study will investigate whether PD-L1 and other immuno-markers will be influenced by     osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive     advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers     can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the     time of PD due to osimertinib resistance.   "
19556|NCT03029845|"     The purpose of the study to evaluate the feasibility of using low dose propranolol for people     with fibromyalgia.   "
19557|NCT03029832|"     This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to     evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo     and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma     (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting     and who are ineligible to receive cisplatin-based therapy.   "
19558|NCT03029819|"     The purpose of this study is to investigate text messaging as a way to enhance     mindfulness-based treatment for smoking cessation.   "
19559|NCT03029806|"     The purpose of this study is to investigate the role dietary salt plays in epigenetic     regulation of blood pressure, focusing on the salt-sensitive regulatory enzyme     Lysine-specific demethylase 1.   "
19560|NCT03029793|"     The purpose of this study is to determine whether combination of molecular and biomarkers     with functional imaging can predict pathologic response and clinical outcomes in squamous     esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant     chemoradiotherapy and surgery   "
19561|NCT03029780|"     The purpose of this study is to evaluate safety and efficacy of different administration     regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.   "
19562|NCT03029507|"     The proposed study is a cohort-randomized controlled trial of Acceptance and Commitment     Therapy-enhanced ShipShape (ACT+SS) compared to the standard ShipShape-only program, for     overweight or obese Navy personnel.   "
19563|NCT03029494|"     The objective of this study is to quantify salivary oxidative stress biomarkers in patients     with temporomandibular disorders and to quantify recently isolated endogenous peptide     opiorphin in saliva of these patients. As chronic exposure to stress may cause hyperalgesia     as a result of the stress response in the hypothalamic-pituitary-adrenal axis, aim is to test     this as an underlying mechanism by correlating opiorphin and oxidative stress markers to     salivary cortisol levels. The aim is to assess the association of oxidative stress salivary     biomarkers with muscle and joint pain and to measure opiorphin, a potential biomarker of     different pathological states.   "
19564|NCT03029481|"     Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with     relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy     options. A large body of preclinical data supports a role for IGF-1R inhibition in the     treatment of Ewing sarcoma.      More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-     agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human     monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded     access IND to provide our patient the opportunity to benefit from this treatment after having     developed progressive disease after multiple lines of prior therapy.   "
19565|NCT03029468|"     The primary aim of this study is to test the feasibility and acceptability of implementing a     multimedia computerized cognitive behavioral therapy (cCBT) program for reducing SCD pain     symptoms in a single-arm pilot pragmatic clinical trial. The investigators will recruit 40     SCD patients with chronic pain or on chronic opioid pain treatment to receive 8 sessions of     cCBT through our Web- and smartphone-based iCanCope with SCD program and weekly follow-up     with a care coach. Participants will also use the iCanCope smartphone app to track daily pain     intensity, pain interference and mood. The primary outcomes of the trial include feasibility     (recruitment, retention, provider and patient feedback) and acceptability (sessions     completed) of the iCanCope SCD program.   "
19566|NCT03029455|"     Evaluate the safety and tolerability of VX-659 in healthy subjects   "
19567|NCT03029442|"     The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the     loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis     in women after menopause who have an increased risk for fractures, to treat women receiving     certain treatments for breast cancer who have an increased risk of fractures, and to treat     bone loss in men receiving certain treatments for prostate cancer who have increased risk for     fractures. This drug is considered experimental for the purpose of this study. Study     participation will last for approximately 12 months (6 study visits total), visits will range     from1-4.5 hours depending on the number of tests that need to be completed. The study is a     double-blinded placebo trail in which the participant will be randomly assigned to on of two     groups, Denosumab injections or placebo - inactive salt solution injections.   "
19568|NCT03029429|"     Pseudohypoparathyroidism is a genetic disorder with limited treatment options. Patients have     early-onset obesity, short stature and increased risk of type 2 diabetes. This phase 2     clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in     pseudohypoparathyroidism. The investigators hypothesize that theophylline will cause weight     loss, improve glucose tolerance and slow growth plate closure in children and young adults.   "
19570|NCT03029403|"     This is a phase 2 study whose purpose is to see whether the combination of of pembrolizumab,     DPX-Survivac vaccine and low-dose cyclophosphamide has anti-tumor activity in patients with     advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.      DPX-Survivac is an investigational vaccine. A vaccine is a substance that is often given to     stimulate the body's immune system (the structure and processes in the body that protects     against harmful substances) to help prevent against certain diseases. DPX-Survivac is a     vaccine that may teach the immune system to recognize cancer cells and to kill them.      Pembrolizumab is a drug that is approved for the treatment of a certain type of melanoma (a     type of skin cancer) and non-small cell lung cancer. Pembrolizumab blocks the function of a     protein called programmed cell death receptor-1 (PD-1). PD-1 works by keeping the immune     system from destroying cancer cells. Stopping PD-1 from working may help the immune system to     fight cancer cells.      Cyclophosphamide is chemotherapy drug that is approved for the treatment of various cancers     alone and in combination with other drugs.   "
19571|NCT03029390|"     Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including     impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher     risk to develop type 2 diabetes mellitus (T2DM) in 10 years.      The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has     been demonstrated, the first line of pharmacology treatment is metformin, on the other hand,     the traditional Chinese and Ayurverica medicine offer potential active substances for the     treatment of hyperglucemia like berberine.      Berberine is an extract with hypoglycemic effects in animal models as well as in clinical     trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's     activity against metformin in prediabetes would provide impact information on a new     alternative treatment and compare with the standard pharmacological treatment.      The aim of the study evaluate the effect of administration of berberine versus metaformine on     glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.      The investigators hypothesis is that the administration of berberine versus metformin     modifies glycemic control, insulin sensitivity and insulin secretion in patients with     prediabetes.   "
19572|NCT03029377|"     The objective of this study is to measure sympathetic nervous system function and stress     responses in patients with clinically documented and self-reported chronic fatigue that is     worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and     stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS)     and who self-identify with stress induced worsening fatigue, will be compared to data from     normal individuals pre and post-stress.   "
19591|NCT03029130|"     This study evaluates the use of extending time of continual urinary drainage (using     transurethral foley catheter) for patients with early failures of vesicovaginal fistula     repairs. Half of those included will be randomized to replacement of foley catheter for a     length of 14 additional days, while the other half will be discharged (no intervention). Both     groups will be examined for outcomes at 3 months post-repair.   "
19592|NCT03029117|"     It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females     between corrected and uncorrected rheumatic valve lesions   "
19593|NCT03029104|"     This study will assess changes in visual acuity and corneal symmetry after corneal collagen     cross-linking (CXL) of asymmetric corneas.   "
19573|NCT03029364|"     The ability to upregulate fat oxidation at appropriate times such as during fasting, low to     moderate intensity exercise and after a high fat meal, is popularly advocated. This is     presumably due to the perception that a high capacity to utilise fat may improve (ultra)     endurance performance and help in the regulation of body fat and metabolic diseases. In     accordance, impaired fat use at rest has been associated with obesity and insulin resistance     (Kelley et al., 1999). However, there is inconclusive and / or a lack of systematic evidence,     especially in a large diverse range of adults, exploring:        1. Whether whole body fat use during exercise is altered in individuals with overweight or          obesity compared to lean individuals        2. Whether whole body fat use at rest and during exercise is associated with prospective          changes in body composition        3. The intra-individual variability in whole-body fat use at rest and during exercise        4. Physiological, metabolic, lifestyle and genetic characteristics that are associated with          whole-body fat use at rest and during exercise      Therefore, the objectives of this study are three-fold:        1. To explore whether whole body fat use is associated with body composition and          prospective changes in body composition        2. To explore associations between whole-body fat use and physiological, metabolic,          lifestyle and genetic variables        3. To assess the intra-individual variability of whole-body fat use.      This study is an observational, exploratory cross-sectional and prospective study. A wide     range of 'healthy' and 'at-risk of metabolic disease' adults will be recruited.      Participants will be asked to visit a laboratory at the University of Bath three times. Visit     1 is a screening and study familiarisation visit. Visits 2 and 3 are to be completed within     7-14 days and involve lifestyle monitoring (dietary and physical activity), a one-off urine     and blood sample, assessment of fuel use at rest and during exercise (the latter through an     incremental graded cycling exercise test to exhaustion). Body composition will be analysed     via a dual-energy x-ray absorptiometry (DEXA) scan in addition to an optional skeletal muscle     and / or fat tissue biopsy at either visit 2 or visit 3. Participants will also be offered an     optional 4-month follow-up session (Visit 4) that will involve body composition analysis via     a DEXA scan.   "
19574|NCT03029351|"     This is a prospective study to evaluate effect of Exenatide extended release treatment for 1     year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to     placebo.   "
19575|NCT03029338|"     In this single-center, open-label, no control, prospective clinical trial, a total of 10     relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be     enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to     patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The     purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells     in patients with relapsed or refractory CD19 positive B-cell lymphoma.   "
19577|NCT03029312|"     Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak     muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from     muscle training that leads to secondary improvement in bone strength (osteogenic treatment).     Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration     Training (WBVT) improves mobility and also bone strength. No randomized controlled trials     exist in OI children. This randomized controlled pilot study assesses the effect of 5 months     WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children >5     years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a     WBVT group and a control group matched by gender and pubertal stage. Main outcome measure is     the change in tibial volumetric BMD, secondary outcomes include a variety of bone, mobility     and dynamic muscle function variables.   "
19615|NCT03028818|"     To inform the feasibility of conducting a study to test different temperature thresholds at     which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in     critically ill children with fever due to infection.   "
19578|NCT03029299|"     BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed     molecular-based in vitro diagnostic platform for infectious disease testing known as the     FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the     FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral     microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS)     specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived     classification by the FDA in October 2016 and is the first highly-multiplexed molecular test     to receive this designation.      The purpose of this study is to measure patient outcomes following implementation of the RP     EZ test and to also gather data about physician office workflow and user interactions with     the device. These data will be used to understand how the adoption of such tests may     influence patient care in the CLIA-waived setting.   "
19580|NCT03029273|"     TCR-T cell therapy experienced a breakthrough for treating tumors in recent years. Phase I /     II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma conducted by     the Rosenberg team at the National Cancer Institute showed that 61% Synovial cell sarcoma and     55% melanoma had therapeutic responses. Another report of a phase I / II clinical trial for     multiple myeloma showed that 20 patients received high affinity anti-NY-ESO-1 and LAGE-1     specific TCR-T treatment, 16 of them (80%) had the average progression-free survival of 19.1     months with minor side effect. These achievements indicate that TCR-T cell therapy can target     a variety of tumors including solid tumors without any severe side effects found in CAR-T     trials.      This study is mainly focused on tumor testis antigen (Cancer-Testis Antigen), because it is     not expressed in normal cells. NY-ESO-1 antigen is commonly expressed in 10-50% of melanoma,     lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of     multiple myeloma cases, and 70-80% of synovial cell sarcoma. Approximately 700,000 new cases     of lung cancer are identified each year in China, 70% of them die within one to two years     after diagnosis due to the lack of effective treatment. To address that unmet needs, our     TCR-T treatment targets non-small cell lung cancer with NY-ESO-1 antigen expression.      This study will investigate the safety and tolerability of TAEST16001 (TAEST: TCR Affinity     Enhancing Specific T cell Therapy, autologous T cells transduced with affinity enhanced     NY-ESO-1 TCR) cell therapy in subjects with NSCLC who have received prior therapy for their     disease but their disease has progressed or relapsed.   "
19581|NCT03029260|"     This study aims to compare the effect of tension neural mobilization versus sliding neural     mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold     and on flexibility both in the dominant lower limb (subjected to mobilization) and the     non-dominant lower limb (not subjected to mobilization) in healthy young participants.   "
19594|NCT03029091|"     The purpose of this study is to test the safety and effectiveness of Losartan potassium in     subjects with Eosinophilic Esophagitis (EoE), both those with a connective tissue disorder     (CTD) and those without a CTD.   "
19595|NCT03029078|"     Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug     Resistant (XDR) bacteria by performing a fecal transplantation.   "
19582|NCT03029247|"     This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD)     subjects with anemia associated with chronic kidney disease (CKD), designed to compare the     effects of daprodustat to epoetin alfa on blood pressure (BP).      After a 4-week screening and a 4-week erythropoesis-stimulating agent (ESA) washout period,     on Day 1 subjects will be randomized 1:1 and stratified by prior ESA dose before they undergo     Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the highest     planned once-daily maintenance dose of daprodustat (24 milligrams [mg]) to the highest     starting dose of epoetin alfa (100 international units [IU]/kilograms [kg]). This will be     followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either daprodustat     or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance period, on     Day 57 an Acute Challenge (number 2) will be repeated utilizing the same treatment as of     Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after completing     treatment. The total duration of subject involvement is up to 18 weeks (Screening to     Follow-up).   "
19583|NCT03029234|"     The purpose of this study is to evaluate the safety, tolerability and overall response rate     of carfilzomib in combination with dexamethasone for the treatment of multiple myeloma in     China.   "
19584|NCT03029221|"     This project evaluates Real Relationships, a program provided by the Children's Aid Society     (CAS) in Clearfield County, and funded through the DHHS Healthy Marriage (and Responsible     Fatherhood) program. Research questions focus on recruitment and retention of participants,     and short- and long-term participant outcomes associated with different formats for offering     the program.   "
19585|NCT03029208|"     The study will evaluate the safety and efficacy of daprodustat compared to rhEPO for     treatment of anemia associated with CKD in subjects who are starting dialysis or who have     recently started dialysis. Previous trial in dialysis subjects with anemia associated with     CKD demonstrated that daprodustat could maintain hemoglobin up to 24 weeks with minimal     effects on plasma erythropoietin (EPO) concentration. Daprodustat is postulated to be     associated with fewer major adverse cardiovascular events by raising hemoglobin without the     supraphysiologic EPO concentrations associated with intravenous (IV) rhEPO therapy,     potentially avoiding blood pressure (BP) elevations and other adverse effects of high EPO     levels. This randomized, open-label (sponsor blind) study will comprise three study periods:     a screening period of 2 weeks (can be extended by an additional 4 weeks as needed), a 52-week     active treatment period, and a follow-up period of 4 to 6 weeks. Approximately 300 subjects     or 150 subjects per treatment group will be randomized 1:1 to receive daprodustat or rhEPO     (darbepoetin alfa).   "
19616|NCT03028805|"     This is a fully automated randomized trial with two randomization branch-points. The first is     inclusion of disease-specific orders in the admission orders based on a predictive model     using real-time data. The second is the use of dynamic orders that are end-user tested rather     than static orders designed by a committee. The primary hypothesis is that automatic     inclusion of disease specific orders with admission orders will improve adherence to     guidelines for patients with COPD. The secondary hypothesis is that clinical and operational     outcomes will improve, thereby improving value.   "
24039|NCT02971007|"     This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy     of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the     treatment of moderate to severe VVC.   "
19586|NCT03029195|"     The cleft lip and palate (CLP) is the commonest craniofacial anomaly worldwide. Nasoalveolar     molding (NAM) therapy has emerged in the management of CLP as an early presurgical     intervention to provide symmetry to severely deformed nasal cartilage, achieve projection to     the flattened nasal tip, provide nonsurgical elevation for the columella, improve alignment     of the alveolar ridge, reduce the cleft gap and it could significantly reduce the number of     secondary surgeries. Despite that NAM therapy is becoming the treatment option for early     cleft care, there is growing debate about its efficacy due to lack of quantitative assessment     of these findings. To provide the highest levels of clinical evidence on NAM therapy, there     has been international call for Randomized Controlled Clinical Trials.      Statement of the problem: lack of quantitative data about the efficacy of the NAM therapy for     unilateral CLP.      Aim of the study: is to develop a standardized non-invasive quantitative assessment for two     different techniques of the NAM therapy in Egyptian infants that involves 3D laser     scanning/CAD analysis for maxillary geometry, and nasal anthropometric analysis.      Methods Trial design: Prospective randomized controlled clinical trial (RCT). Settings: The     RCT will be performed through two phases; (Phase I: A controlled pre and post-RCT that will     be designed for the quantitative evaluation of the NAM therapy on the maxillary geometry),     and (Phase II: A post-test RCT will be designed for the quantitative evaluation of the NAM     therapy on the nasal anthropometry and comparing the outcome with the nasal anthropometry     that will be performed to age matched Egyptian norms).      Participants: 30 Egyptian infants with nonsyndromic UCLP will be randomly allocated to study     groups (Group I, n=15) that will undergo NAM therapy before the primary surgical repair, and     control group (n=15) that will undergo the primary surgical repair without NAM therapy. And     15 Egyptian infants will act as norm group.      Follow-up: (phase I- T0: before NAM, T1: after 1 month and T2: before surgery). (Phase II-     T0: 10 days after surgery, and T1: 6 months after surgery).   "
19587|NCT03029182|"     The study will evaluate the utility of hypoxic exercise training to improve cardiovascular     and metabolic health among obese breast cancer survivors. While participants exercise, a     lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach     removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which     is believed to support exercise tolerance. Participants are randomized to either the     treatment (walking+simulated-altitude) or control (walking under normoxic conditions).   "
19588|NCT03029169|"     Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their     presence and management are related to patient´s prognosis. 1c class antiarrhythmics are     seldom administered in intensive care due to a dose dependent toxicity published in case     reports and unfavourable outcome reported in a few prospective trials done on cardiology     patients. The papers on 1c class antiarrhythmics do not take into consideration a complex     haemodynamic assessment using echocardiography. The authors have recently presented a     retrospective study on SV arrhythmias in septic shock patients demonstrating favourable     effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.   "
19589|NCT03029156|"     Background: The bronchodilator therapy is an essential component of the management of asthma     exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is usually     achieved through nebulization (creating small particles to be inhaled). The commonly used     nebulizer device is a small volume jet nebulizer which has not been consistently reliable in     delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA approved device     which produces consistently respirable sized particles which could potentially result in     better bronchodilator effect than the standard jet nebulizer.      Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet     nebulizer in delivering bronchodilators during a severe asthma exacerbation.      Experimental design: Patients will be randomized (like a flip of a coin) to receive     bronchodilator therapy as per the emergency room protocol either via small volume jet     nebulizer or Aeroneb nebulizer.      Subjects: Adult patients between age of 18 and 55 years who present to the emergency room     with severe asthma exacerbation with peak expiratory flow rate <50% of predicted.      Study procedure: When enrolled in the study and after randomization, we will then collect     data that is standard for the hospital like heart rate, blood pressure and breathing indices     and also some non-routine things like some scoring scales for shortness of breath and serial     measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more     effective in delivering bronchodilator medication and thus more effective in managing asthma     exacerbations.   "
19597|NCT03029052|"     Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of     patients. This risk may be linked with discontinuity of care between hospital physicians and     Primary Care Physician (PCP). The investigators aim to assess in this study the impact of     medication reconciliation at discharge associated with a patient's counseling session, both     provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of     medication reconciliation at discharge we expect a reduction by 15% of the number of     prescription changes not maintained by the PCP after discharge.   "
19598|NCT03029039|"     Sepsis represents a serious public health issue characterized by a complex inflammatory     response. In addition to their hemostatic role, platelets display inflammatory functions by     secreting a variety of immunomodulatory factors and interacting with circulating immune     cells. The investigators postulate that, in severe sepsis, platelets become activated and     release amounts of different soluble inflammatory molecules that contribute to     sepsis-associated inflammation. First, the investigators propose to assess whether severe     sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful     platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented     infection, ICU patients with documented infection involving other bacterial species, compared     to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the     investigators wish to assess whether the bacterial species affects the release of platelet     sCD40L and by an extensive screening of platelet soluble factors, the investigators propose     to set up profiles of inflammatory molecules associated with the type of infection. Finally,     the investigators will analyze platelets' activation state and their association with     circulating immune, according to the type of infection. Therefore, this project is expected     to assess to which extent the platelet inflammatory function is super-activated in severe     sepsis and to identify new platelet-related biomarkers of sepsis.   "
19630|NCT03028623|"     The objective of this study is to evaluate the feasibility and safety of salpingectomy versus     standard tubal ligation in women undergoing surgical sterilization at the time of a planned     cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for     ovarian cancer prevention. While this procedure is currently performed during hysterectomies,     its feasibility at the time of cesarean delivery is not well established.      This randomized, prospective clinical trial will compare the two sterilization methods to     demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean     delivery will not result in increased operative time, blood loss or other complications. This     study is necessary to promote salpingectomy as a standard sterilization method during     cesarean deliveries.   "
19599|NCT03029026|"     Aortic stenosis (AS) is the most common valvular heart disease. Once symptomatic with severe     AS, outcome is poor unless the valve is replaced surgically or via transcatheter aortic valve     implantation (TAVI). Transthyretin amyloid (ATTR) deposits are common in the heart muscle in     up to 25% of octogenarians, and after an asymptomatic period of unknown duration, cause overt     heart failure and arrhythmias in a proportion of cases. The prevalence and impact of covert     ATTR amyloidosis in elderly individuals with AS are unknown. Detection would avoid     misdiagnosis, guide treatment and, potentially, improve outcomes. Recent data have shown that     echocardiography, cardiovascular magnetic resonance (CMR), computed tomography (CT), and DPD     scintigraphy, can identify ATTR amyloid deposits, but the clinical performance of these     various tests is unknown.      This study will investigate elderly patients with symptomatic severe AS using imaging to     explore ATTR amyloid in AS and determine its prevalence and impact on outcome.      The investigators aim to recruit a total of 250 patients aged 75 or older being considered     for intervention for severe AS. The prevalence of cardiac amyloid will be assessed in three     arms (sAVR, TAVI and medical therapy, with a likely patient ratio of 50:150:50), using five     investigation modalities - all cohorts (echocardiography and DPD scintigraphy); sAVR cohort     (biopsy and CMR); TAVI cohort (EqCT); medical therapy only cohort (as per work-up/trial prior     to no intervention decision).      The primary outcome measure is patient mortality. Secondary outcomes measures are major     adverse cardiovascular events, length of stay, pacemaker implantation, ECV measured by EqCT     and CMR.      Follow up will be at 1-year with clinical echocardiogram (for sAVR and TAVI patients) and/or     telephone interview for all patients (if not carried out in person at the time of the     echocardiogram).   "
19600|NCT03029013|"     The study is the single arm and single center clinical trials，We conduct the phase II     clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy     sequential treatment with advanced recurrence of metastatic cervical cancer   "
19601|NCT03029000|"     A, multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen     of 10 μg/kg of tbo-filgrastim administered sc daily on the mobilization of CD34+ cells in at     least 60 healthy male and female donors. The pharmacokinetics, pharmacodynamics, safety,     tolerability, and immunogenicity of tbo-filgrastim will be assessed .   "
19602|NCT03028987|"     The purpose of this study is provide a better understanding of the adaptive immune response     to the licensed flu vaccines. The investigators hope the information learned from this study     will help identify and describe important factors of influenza immunity especially of or     specific proteins associated with the T-cell immune response.   "
19603|NCT03028974|"     The purpose of the study is to get a better understanding of the natural and adaptive immune     response to the flu virus and to compare the immune cell responses to FDA-licensed flu     vaccines in nasal mucosal cells and in blood.   "
19604|NCT03028961|"     The purpose of the proposed research study is to evaluate whether bone marrow transplant     patients prefer the Stanford letter advance care planning tool to the standard Advance     directive.      Completion of advance care planning prior to BMT is very important, but not often done. The     investigators believe that the Stanford Letter will be preferred by patients and will allow     them to feel more comfortable and share more of their wishes with family members and the     medical team.   "
19605|NCT03028948|"     This clinical trial studies how well an interactive tailored website works in promoting sun     protection and skin self-check behaviors in patients with stage 0-III melanoma. An     internet-based program may help individuals to perform skin self-checks and engage in sun     protection behaviors.   "
19606|NCT03028935|"     This randomized pilot clinical trial studies how well an evidence-based exercise and     nutrition program adapted for Latinas will work in improving physical activity and dietary     behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program     may reduce the risk for developing certain cancers, obesity, and chronic health conditions in     Latinas who are non-active, overweight, or obese.   "
19607|NCT03028922|"     This clinical investigation is a prospective, multi-centre study to evaluate bone gain after     horizontal augmentation using creos xenogain bone graft substitute. Patients included in the     study are in need of a GBR procedure prior to implant placement in the premolar and posterior     region of the mandible.   "
19608|NCT03028909|"     The purposes of this study are to determine if MEDI8852 administered with standard of care     (oseltamivir) will reduce the time to normalization of respiratory function for adults who     are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an     acceptable safety profile in adults who are hospitalized with influenza caused by Type A     strains.   "
19609|NCT03028896|"     The 90° rotation technique is known to improve the success rate of conventional LMA but its     effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could     increase the first attempt success rate of the insertion of LMA FlexibleTM compared to     standard technique.   "
19612|NCT03028857|"     The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to     pregnant women improves early brain development with improved brain-related development     during the first four years of life. Participating pregnant women will receive either     phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The     primary outcome is the child's behavior at four years of age as reported by the primary     caregiver. Secondary outcomes include motor development, socio-emotional development,     language development, and cognitive development. Potential contributors beyond the     supplement, including maternal stress and placental function will also be assessed.   "
19613|NCT03028844|"     Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and     sucrose versus sucrose on stress   "
19614|NCT03028831|"     Alaska native people (AN) have the highest recorded incidence and death rate from colon     cancer in the world (>90:100,000). We hypothesize that the AN, despite their high consumption     of anti-inflammatory and antineoplastic n-3 fish oils, are at increased risk of colon cancer     because of colonic butyrate deficiency resulting from their remarkably low consumption of     fiber-containing foods. We hypothesize that fiber supplementation of their usual diet will     result in a bloom of butyrate producing microbes in the colon, resulting in increased     butyrate production, which will suppress their high microbial secondary bile acid production,     antagonize the actions of other food (smoked fish) and environmental carcinogens (tobacco,     alcohol), and interact with the high circulating levels of n-3 fish oils to suppress colonic     inflammation and cancer risk. In order to investigate this, we will conduct a randomized     double-blinded 4-week clinical trial in up to 100 randomizable healthy, middle-aged AN     undergoing screening colonoscopy, with the objective of obtaining 60 completed interventions.     The interventions will consist of either a high-dose soluble fiber supplement given as a     drink, together with their usual diet which currently contains about 15g total fiber/d, or to     a control digestible starch drink plus their usual diet. The primary endpoint will be a     clinically significant reduction in Ki67 proliferative colonic mucosal biomarkers of cancer     risk. Microbiome and metabolome mechanisms responsible for the anticipated changes in mucosal     biomarkers will also be investigated. Our results in extreme risk AN will be further     evaluated by comparison to similar measurements previously made in minimal risk rural     Africans and intermediate risk African Americans. Our results will be used to provide the     scientific basis for a definitive large-scale high-fiber supplementation study (to achieve     >50g total fiber/d) to suppress adenomatous polyp recurrence following colonoscopy.   "
19617|NCT03028792|"     This study aims to test the efficacy and feasibility of administering a computerized     attention training program targeting clinical levels of anxiety in Latino youth between the     ages of 8-17. 52 youth from Imperial County, a rural and predominantly Latino region, will be     randomized to receive either 1) a 12-session attention modification program (AMP) or 2) an     attention condition program (non-active treatment). Clinical assessment of symptom severity     will be conducted before, during, and after treatment. We hypothesize that at the end of     treatment, children who receive the active intervention (AMP) will show (1) decreased     attention bias to anxiety-related triggers using an independent measure of attention bias to     assess change and (b) reduced anxiety severity. We also hypothesize that this study will be     feasible, tolerable, acceptable, and safe in this underserved sample of Latino youth. This     study is an initial step towards demonstrating the feasibility of implementing a novel     computerized attention training program in anxiety in underserved community samples.   "
19618|NCT03028779|"     Implementation of Fast-track surgery for total hip replacement and total knee replacement and     evaluation of the risks and benefits for the patients.   "
19619|NCT03028766|"     This trial is to determine what dose of a drug called AZD1775 can safely be given in     combination with cisplatin before surgery and with chemo-radiotherapy after surgery in     patients with Head and Neck Cancer. The Investigators will also get some preliminary     information regarding the effectiveness of this combined treatment.   "
19620|NCT03028753|"     The investigators are trying to determine if using a bladder scanner (type of ultrasound) to     check how much urine is left in the bladder is the same as checking that volume with a     catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the     investigators perform a voiding trial. Water is put into the participant's bladder through     the catheter (tube draining your bladder). The catheter is then removed and the participant     is asked to empty their bladder. After that, the investigators will use the bladder scanner     (ultrasound) to see how much urine is left in the participant's bladder. After the     ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take     out the remaining urine. The investigators will then compare the amount obtained from the     catheter to the ultrasound amount. This will also help the investigators to figure out if     they need to check how much urine is left in a patient's bladder after the voiding trial.   "
19621|NCT03028740|"     The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC)     for the treatment of liver fibrosis in adult subjects with NASH.   "
19622|NCT03028727|"     Laser therapy has been proposed as a novel treatment option in controlling subgingival     microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode     laser as an adjunct to scaling and root planing (SRP) in the management of chronic     periodontitis (CP).   "
19623|NCT03028714|"     Metabolic risk factors, such as central obesity, increase the risk of chronic diseases in     adulthood and are prevalent in many university students. Increasing the knowledge about     healthy nutrition and physical activity can positively impact students' lifestyle and prevent     weight gain. This study aims to investigate the impact of online educational methods on     nutrition knowledge, dietary habits, BMI, and physical activity in a sample of university     students in the UK. Anthropometric measurements will be assessed and questionnaires will be     completed at the beginning and at the end of the study. Written consent will be sought, the     voluntary nature of participation will be emphasized while anonymity and confidentiality will     be strictly maintained.   "
40546|NCT02754882|"     This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of     bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous     non-small cell lung cancer (NSCLC).   "
19624|NCT03028701|"     The overall objective is to asses the bronchodilator effect of single dose of     Formoterol/Budesonide 12/400 mcg fixed combination delivered via Discair® in patients with     COPD.      Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different     times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2     hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).   "
19625|NCT03028688|"     Millions of patients undergo upper GI endoscopy in the United States each year. A large     number of these patients have anesthesia to assist with their comfort during the procedure.     The majority of patients do not have a protected airway during the procedure, meaning there     is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen     via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a     risk for low oxygen saturation during the procedure, which presents a significant patient     safety issue. The purpose of the clinical trial is compare the current anesthesia standard of     care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's     hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with     which patients experience hypoxemia during anesthesia for upper GI endoscopy.   "
19626|NCT03028675|"     Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for     this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical     Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a     1-hour brain scan for both patients and controls. In the first 6 months of the study,     investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement     and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air     and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI,     pH-weighted imaging will be validated for its robustness and reproducibility.   "
19627|NCT03028662|"     This is an experimental study in which the efficacy of three psychophysiological intervention     modalities based on retrieval-extinction procedures is analyzed.   "
19628|NCT03028649|"     The purpose of this study was to verify the effect of 12-week with β-hydroxy-β-methylbutyrate     (HMB) and a placebo (PLA) supplementation on body composition, anaerobic and aerobic     capacity, as well as concentrations of the selected biochemical blood markers in trained     athletes, in a randomised, double-blind, placebo-controlled crossover trial.   "
19629|NCT03028636|"     A prospective, open label post market registry to collect Patient Reported Outcomes in an     online data capture registry, maintained by Pelvalon, of women with fecal incontinence     exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel     control.   "
19634|NCT03028571|"     The investigators will test the null hypothesis that there will be no changes in the     insulin-mediated suppression of endogenous glucose production (EGP) in response to autonomic     blockade. To test this hypothesis, the investigators propose to determine the role of the     autonomic nervous system in hepatic insulin resistance.   "
19635|NCT03028558|"     Electronic cigarettes (EC) are battery powered nicotine delivery devices that aerosolize     nicotine and other flavor constituents. Despite the increasing use of EC, little attention     has been paid to their possible adverse effects on human health. Theoretically, the risk     relates to nicotine per se and/or the propellants or contaminants in the EC aerosol. The     hypothesis underlying the proposal is that chronic EC smoking disorders the biology of the     oral epithelium, the first cell population exposed to inhaled EC vapors. Using a     cross-sectional, cohort-comparison of EC smokers compared to age-, gender- and     ethnicity-matched never smokers, the investigators propose to assess the oral epithelium     obtained by punch biopsy or brushing from 100 EC smokers and 25 nonsmoker controls. The EC     study cohort will be restricted to young adults (age 21-35 yr) with no prior history of     tobacco smoking, but who have smoked EC for >6 months.   "
19645|NCT03028428|"     In this study, researchers want to determine the safety of MSCs that a patient can tolerate     without causing side effects. Moreover researchers will also be looking at the function of     the knee over time, which may give them some insight on the usefulness of MSCs as a treatment     option.   "
19646|NCT03028415|"     To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in     a population indicated for single, double, or triple hindfoot arthrodesis or ankle     arthrodesis surgery with supplemental graft material.   "
19647|NCT03028402|"     This study aims to determine to what extent patient-specific factors, iatrogenic factors, and     biomechanical factors influence cervical spine mechanics after single-level and two-level     arthrodesis.   "
19636|NCT03028545|"     In the recent context of deinstitutionalization and longitudinal studies pointing to a large     number of positive long-term outcommes for people affected by a psychiatric disorder     (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the     possibility of overcoming the consequences of a psychiatric pathology emerges as a solid     fact. Therefore, the existence of this possibility calls for the identification of the     determinants underlying of the various outcomes over time of those affected by a severe     psychiatric disorder, in particular those likely to underpin the most positive developments.      While it is well known from a medical point of view that certain dimensions affect the     prognosis of persons affected by a severe psychiatric disorder (such as the persistence of     negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely     medical perspective (and putting aside the role of the person and his environment) seems to     be able to account only for a modest proportion of the prognosis of people affected by a     serious psychiatric disorder.      It is this fact that has gradually led to the emergence of complementary models capable of     enriching the understanding of the determinants of the future of people affected by a severe     psychiatric disorder, in particular models inviting to separate becoming of the person from     the  psychiatric disorder to take into account the personal role of the person in his or     her own healing. This perspective is the recovery perspective.      Recovery process is defined as a personal trajectory which includes the person's experiences     and the reactions of his / her environment following the installation of a psychiatric     disorder, which can support a mode of release of the status of psychiatric patient.     Recovery thus implies an approach underpinned by the understanding of the human response to     pathology (Noiseux) and, one might add, of its environment.      This definition of recovery is also subjective because it is tied to very personal     experiences and related to the person's own norms as to what it means to be re-established.     The subject engages in a long, progressive process, without return to the previous state. In     a dynamic response to an equilibrium perturbed by the disease, we are interested in restoring     a new equilibrium rather than the factor triggering its loss. Recovery is seen as a     trajectory punctuated by decisive moments on a background of progressive change, this process     oscillates between awareness, ambivalence and forward shift.      However, while these studies point to a number of crucial dimensions involved in the recovery     of a severe psychiatric disorder, one of the important limitations of these studies is the     distance from any psychopathological consideration, thus setting aside the possibility of     specific processes of recovery depending of the pathology. The identification of recurrent     experiential logics specific to the various psychiatric disorders therefore appears to be an     important field of investigation. It would potentially be able to guide the development of     new therapeutic devices based on the recovery model.   "
19637|NCT03028532|"     Clomiphene (Clomid) is a drug FDA approved to treat female infertility, however, it is often     used by men in an off-label setting to both treat male infertility and in a multitude of     sports disciplines to increase performance.      Study Objectives:        -  Determine detection windows for clomiphene and its metabolites in urine following a          medium-term administration        -  Understand the effect of clomiphene administration on luteinizing hormone (LH),          follicle-stimulating hormone (FSH), and serum testosterone (T) concentrations in a          longitudinal manner        -  Identify changes in current steroidal module of Athlete Biological Passport   "
19638|NCT03028519|"     This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of     diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D     receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D     repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in     these patients.   "
19639|NCT03028506|"     The purpose of the proposed study is to assess the distribution of carbohydrates and fat in     the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at     the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The     carbohydrate distribution and fat content of the meal will be compared to maternal glucose     control, preprandial glucose levels, and the percentile for weight of the infant at birth. In     addition, each meal and snack will be classified as low-moderate fat or high fat.   "
19640|NCT03028493|"     This study serves to test a previously evaluated falls prevention intervention recommended by     the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the     Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is     accessible to older adults with low vision receiving services from the Southeastern Blind     Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE     intervention that has been adapted to be accessible for individuals with low vision at SBRC.   "
19641|NCT03028480|"     This study is a special drug use investigation program of NUCALA (a brand name for     Mepolizumab) administered subcutaneously (SC). In this study the information regarding the     safety and effectiveness of long term use of NUCALA after subcutaneous injection will be     collected from Asthma subjects in daily clinical practice. The observation period per subject     will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2     years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline     [GSK] group of companies   "
19658|NCT03028259|"     A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected     prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital,     typically up to 1 week after deliver) will be conducted. These women are of any age and all     ethnic backgrounds delivering at St. Mary's Health Center.   "
19642|NCT03028467|"     This is a randomized, double-blind, parallel group, 3 dosage level, placebo-controlled, Phase     1/2 study designed to evaluate the pharmacokinetics, safety, tolerability, and efficacy of     the monoclonal antibody GSK3196165, in Japanese subjects with active moderate-severe     rheumatoid arthritis (RA) despite treatment with methotrexate(MTX). The subjects will receive     GSK3196165 in combination with methotrexate therapy for the 12 weeks of treatment period.     Approximately 55 subjects will be screened to achieve 40 randomized subjects, so as to have     approximately 10 subjects in each treatment group.   "
19643|NCT03028454|"     The objective of the study is to determine whether five days of ginger (Zingiber officinale)     supplementation is effective at reducing muscle soreness and improving muscle function     following downhill running. Long-distance running is often associated with acute muscle pain,     swelling, and reduced muscle functioning, and consequently, many runners utilize     non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal     side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and     symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is     Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from     osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is     effective at reducing general pain and muscle soreness. Therefore, this study will supplement     60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day     of, and 2 days after downhill running. Participants will be evaluated for muscle soreness and     function before and after the downhill run.   "
19644|NCT03028441|"     This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison     trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3     immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects     aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration     is approximately 8-13 months. The primary objectives are to evaluate the safety and     tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and placebo following two     consecutive intramuscular injections and to assess the CHIKV serum plaque reduction     neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 of     MV-CHIK or placebo on day 29 following the first dose.   "
19649|NCT03028376|"     The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and     GFAP measurements in prediction of need for neurosurgical observation and/or intervention in     moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will     benefit from neuro surgical expertise in specialized departments and thereby possibly better     patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption     and streamline patient courses by predicting the presence of neurotrauma.      Hypotheses:        1. A prehospital serum S100B level > 10 microgram g/L and expectedly above a certain and          currently unknown cut-off value indicates the need for neurosurgical observation and/or          intervention in moderate TBI patients.        2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can          significantly predict a need for urgent neurosurgical observation and/or intervention in          moderate TBI patients.        3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and          GFAP can significantly predict a need for urgent neurosurgical observation and/or          intervention.        4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and          GFAP can significantly predict hospital course and outcome of patients with moderate          TBI.   "
19650|NCT03028363|"     The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil     Gel compared to vehicle in patients with acne vulgaris   "
19651|NCT03028350|"     The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for     the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that     involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other     nonsteroidal anti-inflammatory drugs.   "
19652|NCT03028337|"     The goal of this clinical research study is to learn whether delivering spine radiosurgery in     a single large dose is better than delivering spine radiosurgery over 3 smaller doses.      Researchers also want to learn about the effects of a single dose on participant's symptoms,     pain, and quality-of-life.   "
19653|NCT03028324|"     The purpose of this study is to assess the influence of transcranial magnetic stimulation     (TMS) on speech performance in individuals with primary progressive apraxia of speech.   "
19654|NCT03028311|"     The goal of this clinical research study is to learn about the safety of giving SIR-Spheres     treatment to patients with liver cancer in the same session rather than over 2 sessions,     which is the standard of care.   "
19655|NCT03028298|"     Each year, approximately 30,000 people in the United States suffer an intra-cranial     hemorrhage due to aneurysmal rupture. Of those surviving the initial event, up to 40% will go     on to have further neurological injury secondary to stroke (delayed cerebral ischemia) caused     by constriction of blood vessels (i.e. vasospasm). Previous studies have shown that the     medication sildenafil, given intravenously, improves vasospasm, but has an associated degree     of hypotension. The degree of hypotension was well within safety thresholds for these     patients.      Sildenafil is a medication that strongly inhibits the protein phosphodiesterase-V (PDE-V).     The hypothesis for this study is that oral sildenafil will also improve vasospasm, but does     not result in as much hypotension. Specifically, the investigators look to show that     comparable doses of oral sildenafil produces the same degree of PDE-V inhibition as an     intravenous dose while the degree of hypotension is reduced. Additionally, using measurements     of cerebral blood flow regulation acquired using transcranial Doppler ultrasound, the     investigators look to show that oral sildenafil produces the same degree of improvement in     vasospasm and blood flow regulation.   "
19656|NCT03028285|"     Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its     effects include vasodilation, protection of inner layer of blood vessels and improvement of     blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability     of Unifusol infusions in healthy volunteers.   "
19657|NCT03028272|"     The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and     functional outcomes as fascia when used for tympanoplasties while offering benefits including     reduced operative time, better patient satisfaction, and fewer complications.   "
19659|NCT03028246|"     The goal of this prospective, non-randomized, single-arm, feasibility study is to develop     data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial     tumors which require clinical intervention in pediatric and young adult subjects.      Indication of Use: Ablation of benign intracranial tumors in children and young adults which     are ExAblate accessible.   "
19660|NCT03028233|"     The study will test the impact of a community health worker (CHW)-delivered intervention     aimed at helping families overcome barriers to childhood obesity prevention. Barriers include     social, environmental, and family issues.      This intervention will be compared to a control condition consisting of a community health     worker (CHW)-delivered intervention aimed at helping families improve positive parenting     skills.   "
19661|NCT03028220|"     Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes     complications and self monitoring of glucose levels is an important component of achieving     and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose     control in all age groups when used continuously, and reduces the incidence of low blood     glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the     commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can     become less aware of it. This reduced aware of hypoglycaemia has significant risks including     seizures, coma and even death, and has an impact on people's ability to drive and function.      The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of     retrospective continuous glucose monitoring data to users when the monitor is waved in     proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14     days and is non-adjunctive (does not require calibration to capillary blood glucose).      This clinical study proposes to assess the impact of Libre on frequency, duration and     severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people     with impaired awareness of hypoglycaemia.   "
19662|NCT03028207|"     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality     worldwide and hence, estimating its prevalence is important. Since 2007, there are few data     on the prevalence of COPD in the general population in Spain. The main objective of this     epidemiological observational study is to estimate the prevalence of COPD in residents of     Spain among the population over 40 years of age. The subjects will be distributed in two     groups depending on the presence and absence of COPD. The study will have a single visit in     which a brief interview will take place and subjects will need to complete the medical tests     the case report form with a series of questionnaires. No drugs will be administered in this     study.   "
19663|NCT03028194|"     Use of Postpartum uterine curettage in reducing hospitalization time or in improving the     clinical evolution of the patient with preeclampsia/eclampsia.   "
19664|NCT03028181|"     The study aims to assess and analyze some selected antioxidants and laboratory parameters     during hospitalization of the patients with acute pancreatitis. It will allow to better     understanding of the mechanisms of disease and the development of better diagnostic,     treatment and monitoring.      It is an observational diagnostic study and does not involve any additional administration of     medicinal substances, modification of treatment or dropping the use of routine methods of     treatment of a disease. The study procedure includes detailed personal medical history as     separate document like as a routine medical interview, and three times taking a small amount     of venous blood (together about 15 ml), in the first, third, and seventh day of     hospitalization (in the case of longer hospital treatment).   "
19665|NCT03028168|"     Current therapies for heart failure (HF) bring together strategies to improve quality of life     and exercise tolerance, as well as to reduce morbidity and mortality. Some HF patients     present changes in the musculoskeletal system and inspiratory muscle weakness, which may be     restored by inspiratory muscle training, thus increasing respiratory muscle strength and     endurance, maximum oxygen consumption (VO2), functional capacity, respiratory responses to     exercise, and quality of life. Yoga therapies have been shown to improve quality of life,     inflammatory markers, and VO2 peak in HF patients, mostly with reduced ejection fraction     (HFrEF). However, the effect of different yoga breathing techniques in patients with HF with     preserved ejection fraction (HFpEF) has yet to be assessed.   "
19666|NCT03028155|"     Colorectal Cancer (CRC) is the third most common cancer and the fourth most common cause of     cancer-related death worldwide. CRC frequently gives rise to transcoelomic spread of tumor     cells in the peritoneal cavity, which ultimately leads to Peritoneal Carcinomatosis (PC). A     new loco-regional treatment modality combines Cytoreductive Surgery (CRS) and Hyperthermic     Intraperitoneal Peroperative Chemotherapy (HIPEC). The current HIPEC dosing regimens for the     treatment of colorectal PC can be divided into body surface area (BSA)-based protocols and     concentration-based protocols. Most groups currently use a drug dose based on calculated BSA     (mg/m2) in analogy to systemic chemotherapy regimens. These regimens take BSA as a measure     for the effective contact area, represented as the peritoneal surface in the formula for dose     intensification. However, an imperfect correlation exists between actual peritoneal surface     area and calculated BSA. Sex differences, but also altered pathophysiological characteristics     or frequent complications in patients (ascites) are responsible for differences in peritoneal     surface areas, which in turn affect absorption characteristics. This takes us away from the     initial homogenous drug concentration desired, increasing the variability in the systemic and     tumor exposure to the drug. Pharmacokinetic changes induced by the volume of chemotherapy     solution with constant drug dose, administered intraperitoneally, have already been reported.     This resulted in less precise predictions of the toxicity associated with the treatment. By     contrast, some groups use a totally different dosimetry regimen based on concentration. From     a pharmacologic point of view, the big advantage of a concentration-based system is that the     residual tumor nodules after CRS are exposed to a constant diffusional force and, thus,     cytotoxicity. Unfortunately the prize to be paid for a better prediction of the efficacy of     the IP chemotherapy is a high unpredictability of the levels of plasmatic cancer chemotherapy     and, thus, toxicity. This randomised non-blinded phase III clinical trial will be the first     trial to pharmacologically evaluate the two dosing regimens, BSA-based and     concentration-based, both applied as standard of care in current practice.   "
19667|NCT03028142|"     This is a phase II, randomised, double blind, placebo controlled, complete block, three way     crossover study to investigate treatment with nebulised RPL554 and tiotropium together in     patients with moderate to severe chronic obstructive pulmonary disease (COPD). The purpose of     this study is to assess the bronchodilator effect (opening of the airways) of RPL554 when     used in combination with a long acting anti-muscarinic receptor antagonist (tiotropium)     whilst dosing the RPL554 to steady state blood levels. It is planned to randomise up to 30     patients to have 24 evaluable patients at one study centre. In each treatment period,     patients will receive an open label dose of tiotropium from a dry power inhaler (DPI)     followed immediately by a double blind dose of either RPL554 6mg, 1.5mg or placebo (depending     on treatment sequence) from a nebuliser in the morning on Day 1, Day 2 and Day 3. The dose of     RPL554 or placebo will be repeated in the evening on Day 1 and Day 2; there will not be an     evening dose on Day 3.   "
19671|NCT03028090|"     This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip     Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central     catheter (PICC) tip confirmation technology. The study was to promote the development of a     software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform.     All study participants received PICCs as their standard of care.   "
19672|NCT03028077|"     This study was conducted to investigate the effects of daily supplementation of GS-3K8 or     GINst15 on acute respiratory illness (ARI) in healthy subjects.   "
19728|NCT03027349|"     Background:      Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the     diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.      As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be     considered a good candidate tool in the diagnosis of PHPT.      AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the     diagnosis of PHPT.      Study design: Retrospective, observational, cross-sectional, case-control clinical trial will     be carried out.      Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.   "
19673|NCT03028064|"     Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing     population, antiplatelet drugs are increasingly being prescribed for treatment and     prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet     dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the management     of patients on antiplatelet drugs or anticoagulants is a challenge. One has to carefully     balance the bleeding against thrombo-embolic risks. Therefore measuring platelet function     should be integral in the management plan. A quantitative measurement allows titration of     platelet function in accordance with bleeding or thromboembolic risk. Platelet function has     not been studied in a large cohort of patients with acute upper gastrointestinal bleeding. As     a first step, the study will determine if platelet dysfunction is associated with clinical     outcome. In this prospective, observational single centre cohort study of consecutive     patients with overt signs of acute upper gastrointestinal bleeding, their platelet function     by point of care tests (light transmittance aggregometry, verify now p2y12,the platelet     function analysis system (PFA-100) upon their admissions. Patients will be followed up for 30     days after trial enrollment. The primary endpoint is defined as significant bleeding that     requires interventions (endoscopic, radiologic or surgery). Secondary end points include     cardio- and cerebrovascular thrombo-embolic events and all cause deaths. A receiver operating     characteristic (ROC) curve analysis is calculated for each point-of-care test to evaluate if     individual test can distinguish between patients with and without primary end point. This     study aims to evaluate the capability of platelet function tests to predict clinical outcome     in patients with AUGIB. Logistic regression models will then be built in search for     independent correlates to the primary and secondary endpoints and to adjust for confounding     variables.   "
19674|NCT03028051|"     Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that     aims to analyze life style factors, socioeconomic and psychometric properties, metabolic     problems, drug use, quality of life and biochemical variables in chronic non-cancer pain     patients. The life style factors will be compared to those of normal population. At baseline,     the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and     blood pressure are measured, pain-related factors are recorded and blood samples taken.     Changes in the quality of life of the study patients will be evaluated by questionnaires     during follow-up at 2 years and 5 years.   "
19675|NCT03028038|"     The purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is     effective in reducing alveolar bone loss that happens after each rapid maxillary expansion     (RME) on the buccal aspect of the posterior teeth.      16 patients with a skeletal maxillary constriction aged between 10-16 years old will get into     orthodontic treatment to widen the maxilla using Hyrax appliance.      An amount of patient blood will be withdrawn and centrifuged to get PRP. Then the PRP will be     injected in one half of each patient mouth in a split-mouth design, beneath the buccal     periosteal of the first molars and first premolars, the halves will be chosen randomly.      High resolution CBCT images will be taken before and after orthodontic treatment to analyze     buccal bone thickness and height changes.   "
19676|NCT03028025|"     The primary objectives of this study are to evaluate the performance of StatSeal Advanced     used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB)     relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or     24 hours, whichever occurs first, and the Time to Hemostasis (TTH).   "
19677|NCT03028012|"     Hypothesis      The main hypothesis of this study is that anti-inflammatory medications (ketorolac or     dexamethasone) will provide longer-lasting and greater pain relief than just lidocaine in     trigger point injections where a local twitch response is evoked at the time of the     injection.      Purpose/Specific Aims      The primary objective of this study is to compare the efficacy of three substances used in     TPIs with a LTR identified at the time of the injection: a CS (dexamethasone), a NSAID     (ketorolac), or only a local anesthetic (lidocaine).   "
19680|NCT03027973|"     This study compares two treatments for the management of heavy menstrual bleeding, ulipristal     acetate (UPA) and tranexamic acid (TEA), on health-related quality of life. Half of the     participants will receive UPA and a placebo, and the other half will receive TEA and a     placebo.   "
19681|NCT03027960|"     The investigators propose a small pilot proof of concept study to not only prove the     existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin     in patients with heart failure. The investigators propose a 50 patient randomized,     double-blind, placebo-controlled crossover study with patients with stable HF, type II     diabetes and an eGFR >45ml/min/1.73 m2 who are chronically receiving loop diuretics.   "
19682|NCT03027947|"     The goals of this study are to provide sensory information to amputees and reduce phantom     limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal     nerves convey sensory information from peripheral nerves to higher order centers in the     brain. These structures still remain intact after amputation and electrical stimulation of     the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated     to generate paresthetic sensory percepts referred to portions of the distal limb. Further,     there is recent evidence that careful modulation of stimulation parameters can convert     paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in     amputees. However, it is currently unclear whether it is possible to achieve this same     conversion when stimulating the spinal nerves, and if those naturalistic sensations can have     positive effects on phantom limb pain. As a first step towards those goals, in this study,     the investigators will quantify the sensations generated by electrical stimulation of the     spinal nerves, study the relationship between stimulation parameters and the quality of those     sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify     the effects of that stimulation on the perception of the phantom limb and any associated     pain.   "
19684|NCT03027921|"     The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic     liver diseases. The early detection of fibrosis is important for determining disease     progression and postponing the evolution of chronic hepatitis into cirrhosis via the     implementation of prompt and specific treatment. However, as chronic liver disease can remain     asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when     life-threatening complications start appearing.      Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. In     this setting, blood fibrosis tests and transient elastography have been shown to be accurate,     and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic     liver diseases. However, these tests are usually performed by a hepatologist to whom the     patient has been referred following the appearance of symptoms suggestive of chronic liver     disease. Thus the number of patient diagnosed early by these new tools, that is in the period     before symptoms start appearing and during which preventative measures may be particularly     beneficial, remains quite low in relation to the prevalence of the disease. This prevalence     has been estimated to 0.5 to 2.8 % in general population.      Many studies have identified the value of hemodynamic and morphological ultrasound parameter     in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely     used for various symptoms, and thus could be an excellent way to detect patients with signs     evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for     confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be     feasible during a nonspecific US examination, and by any radiologist, these signs should be     easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase     the screening interest of ultrasound examination.      The main aim of the present study was thus to validate 3 simple US signs in patients referred     for ultrasound abdominal examination for reasons other than suspicion of liver disease.   "
19685|NCT03027908|"     This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240     healthy female and male participants aged over 18 years will participate. The participants     will be randomised into two groups. Participants will be randomly assigned to the test groups     according the allocation table prepared by the Statistician.      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.     After enrollment participants will have their teeth cleaned using a professional prophylaxis     polish by the study hygienist. The participants will then be provided with a standard     cosmetic silica fluoride toothpaste and a toothbrush to use at home, twice a day for up to     four weeks. After this time, they will return to the test site and have the baseline dental     assessments. Participants will then be randomly allocated to one of the two test products     which they will use at home, twice a day for the duration of the study. Dental assessments     will be conducted after 13 and 26 weeks of product use at the study site.   "
19686|NCT03027895|"     The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and     tubular metal stent on the drainage of pancreatic pseudocyst, mainly to observe the     complication rate after treatment.   "
19687|NCT03027882|"     The purpose of this study is to examine the inter/intra rater reliability as well as the     validity of the Swing Test in asymptomatic adults . In addition, this study will examine if     there are musculoskeletal predictors to the movement quality of the swing test.      The Swing Test is a movement test used by physical therapists to identify movement problems     during a simulated running stride   "
19688|NCT03027869|"     Healthy volunteers will be recruited. All subjects will be tested a battery of     neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET)     and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with     transcranial direct current stimulation (tDCS) for 15 minutes. Half of subjects will receive     real tDCS and the other half will receive sham tDCS.   "
19689|NCT03027856|"     The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS     for treatment of coronary bifurcation lesions.   "
19690|NCT03027843|"     Assisted reproduction treatment in patients with low ovarian reserve is a big difficult     clinical problem. Growth hormone (GH) is crucial in the development of follicles since     preantral follicle to ovulation and can promote steroid hormones and gamete formation,     increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research     shows that GH can improve egg quality through regulating mitochondrial function of the     oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion     of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of     assisted reproduction 30 years experience of applicable people, but drug dosage, drug     intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation     medicine expert consensus recommend joint GH for poor ovarian response, repeated implantation     failure patients and older patients assisted fertility treatment, but not on the specific use     time limit, the daily dose of drugs and curative effect. How to maximize growth hormone     potential advantage in improving the egg quality bothers the clinical doctors. We had a     self-controlled retrospective analyses in growth hormone application and found that the     average daily injections of GH dose 2 iu for 45 days can significantly improve the embryo     quality in patients with low ovarian reaction. And now long-acting recombinant human growth     hormone is available, which make it convenient for patients. A forward-looking experimental     is expected to answer clinical practical problems and provide proper GH regimen for low     ovarian responder.   "
19691|NCT03027830|"     Even in the era of drug-eluting stents, bifurcation lesions remain one of the most     challenging lesion subsets in coronary intervention practice. This study was performed to     evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch     intervention strategy.   "
19692|NCT03027817|"     Positioning a patient in prone position under anaesthesia significantly alters cardiovascular     physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such     patients when positioned in prone position under anaesthesia carry a higher risk of     developing hemodynamic changes and this can compromise spinal cord perfusion.      This prospective observational study was conducted on 30 patients with cervical myelopathy     who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive     cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic     parameters. The hemodynamic parameters were recorded at baseline, post induction, post     intubation, prior to prone position, post prone position, and every five minutes thereafter     upto 20mins.      The hemodynamic parameters that were recorded using the NICOM monitor:        -  HR - Heart rate (beats /min)        -  NIBP - non invasive blood pressure (mmHg)        -  MAP - mean arterial pressure(mmHg)        -  CO - cardiac output (l/min)        -  CI - cardiac index (l/min/m2)        -  SV - Stroke volume (ml/beat)        -  SVV -stroke volume variability (%)        -  TPR - total peripheral resistance (dynes. sec/cm5)   "
19693|NCT03027804|"     A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure     phenomenon and feed more complex biomechanical models to be integrated with clinical imaging     with the final aim to predict Ross operation's outcomes and define strategies to ameliorate     its results.   "
19694|NCT03027791|"     Subjects will participate in a 12-week church-based intervention with five separate     components: 1) participation in weekly group sessions; 2) daily use of Fitbit activity     tracker; 3) daily, twice a day blood pressure monitoring; 4) daily online food tracking; and     5) daily use of VR at home (starting at week 6). Participants will also receive phone     contacts from nurse coaches (twice a week during the first 4 weeks, then once a week for the     remaining 8 weeks), who will answer questions and provide support.   "
19695|NCT03027778|"     The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling     exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and     2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic     parameters 4 months after finishing the exercise intervention (8 months after study     initiation).      The investigators also aim to examine the impact of intradialytic pedaling exercise on     general health, anthropometric measures, physical function, and routine laboratory blood     markers as secondary outcome measures, as well as to assess feasibility, safety and adverse     events associated with the intradialytic pedalling exercise.      Qualitative assessments will be conducted among participants to evaluate the acceptability,     feasibility and sustainability of intradialytic pedalling exercise.      Recruitment of more participants in the future will be considered if warranted.   "
19696|NCT03027765|"     The purpose of the study is        -  To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and          Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.        -  To assess the knowledge, attitude and awareness of constructed space maintainers for          pediatric patients' guardians at Pediatric Dentistry and Dental Public Health          Department, Faculty of Oral and Dental Medicine, Cairo University.      and      - To assess the knowledge, attitude and practice of pediatric dentists towards use of space     maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty     of Oral and Dental Medicine, Cairo University.   "
19697|NCT03027752|"     Comparison of two methods for revascularization of the bifurcation of common carotid artery:     carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty     compared with new technique of carotid endarterectomy with autoarterial remodeling of     bifurcation of the common carotid artery   "
19698|NCT03027739|"     CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in     highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the     safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of     relapse as defined by MRD+ status.   "
19699|NCT03027726|"     Background: The global pandemic obesity has led to increased risk for prediabetes and type 2     diabetes (T2D).      Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program     including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To     identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear     cells in pre-adolescents with high risk to develop T2D and its response to a     multidisciplinary intervention program including exercise.   "
19700|NCT03027713|"     The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in     healthy lung patients due to obtain a reference to guide the weaning in those patients   "
19701|NCT03027700|"     The goal of this study is to learn more about liver fibrosis and methods to detect it. We     will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and     without liver disease.   "
19702|NCT03027687|"     Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over     the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time     till smoking the first cigarette after the intervention. More interesting however, is to     study whether actual cigarette consumption decreases after repetitive tDCS. The current study     will explore this by means of EMA in a large sample of 60 smokers. Participants will receive     twice daily sessions of real tDCS or sham for three days in one week. Furthermore,     electrophysiological responses (ERPs) will be measured at baseline, one day after the last     tDCS session and at three months follow up to study the working mechanism behind the effects     of tDCS.   "
19703|NCT03027674|"     Objective: To compare the efficacy of topical 10% nifedipine versus 5% sildenafil in patients     with secondary Raynaud's phenomenon (RP).      Methods: A randomized, double-blind, placebo-controlled pilot study took place in 10 patients     with secondary RP. Topical 10% nifedipine on one hand and 5% sildenafil on the other hand     were applied. The thumbs didn't receive any cream and served as a control group. The primary     outcome was the improvement of blood flow and vessel diameter of the digital arteries     measured by high frequency color Doppler ultrasound before and 1 hour after treatment.   "
19729|NCT03027336|"     The overall objective of the study is to assess the efficacy of Coleosoma formulation     (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic     patients.   "
19704|NCT03027661|"     This is a prospective randomized controlled trial in which patients that are scheduled to     undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical     block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using     block randomization. The intervention would be performed after the patient is under general     anesthesia, prior to starting the surgery. Patients would be consented in the office or     preoperative area (before receiving sedatives). As far as the intervention itself, it would     consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,     which is standard technique for para-cervical block. The remainder of the procedure will then     continue in a regular fashion. Alternatively, patients in the control group will be injected     with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research     staff will have previously prepared the formulations (saline or bupivacaine) and have sent     them to the operating room prior to beginning the procedure depending on assigned group. At     the end of the case, pain will be assessed using a visual analogue scale with a range from 0     to 10 by one of the researches who will also be blinded to the group. This will be done at 30     and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care     unit (PACU) will be standardized to all patients.      Hypothesis:      Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy     significantly reduces pain after the procedure   "
19705|NCT03027648|"     Objective: To investigate the effects of levonorgestrel-releasing intrauterine system     (LNG-IUS) for symptomatic adenomyosis.      Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed     (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient     clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before     and after placement of LNG-IUS, during each following period, all the parameters were     recorded prospectively, including carrying status of IUS, symptoms and scores of     dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation     patterns and adverse effects.      Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea      Second outcome measures: carrying status of IUS   "
19706|NCT03027635|"     Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small     volume fluid drainage at home. The treatment may improve the management of ascites and have a     beneficial effect on the quality of life.      This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter     (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic     resistant ascites.      The trial is an investigator initiated, randomised, single blind, parallel arm, controlled     trial.      Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will     receive ciprofloxacin to prevent spontaneous bacterial peritonitis.      We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total     duration of follow up is six months. The primary outcome is paracentesis free survival.   "
19707|NCT03027622|"     The complications that could occur during or after the extraction of the mandibular third     molar teeth with pericoronitis affect patient's life quality considerably. Various scales are     used to reveal how much the life quality of patients is affected this treatment. The aim of     this study is to identify the long term life quality of patients through the OHIP-14 TR scale     without removing the mandibular third molar teeth with mild pericoronitis.   "
19708|NCT03027609|"     Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic     of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia     caused by P. aeruginosa.   "
19709|NCT03027596|"     Burned skin areas, which were initially vital, can be irreversibly damaged by wound     progression. The aim of the present study is to evaluate the feasibility of ischemic     conditioning to reduce secondary wound progression.   "
19710|NCT03027583|"     This trial is a single-site, randomised, double blind, placebo-controlled, two-armed     parallel-group trial in healthy adult volunteers. The trial will investigate the effect of     oral supplementation of the probiotic strain Bif195 on the ability to attenuate     exercise-induced deterioration of intestinal barrier function and gastrointestinal symptoms.   "
19711|NCT03027570|"     80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of     overweight children.The intervention group will use the app Just Dance Now and The control     group will be exposed to the usual program without the app. Measurements will be performed at     the beginning of the program, the end and 3 months after completion of the intervention.   "
19712|NCT03027557|"     The only known cure for primary hyperparathyroidism is surgical removal of one or more     parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not want     to undergo a procedure due to fear of the associated risks. Therefore a medical alternative     is warranted.      This study aims to evaluate the effects of Denosumab alone, and in combination with     Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism,     with mild osteoporosis. To the best of our knowledge no previously reported randomized     controlled trial has investigated the use of denosumab in primary hyperparathyroidism.      60 patients will be enrolled in three different treatment-groups: 20 receiving both Denosumab     and Cinacalcet, 20 Denosumab and placebo and 20 placebo and placebo. Patients included do not     meet the criteria for, or have no wish for a surgical procedure.      By combining the two drugs, this study could possibly contribute to the discovery of a     realistic medical alternative to surgery. It is expected that the therapy will be able to     both control s-calcium and s-intact parathyroid hormone (iPTH), and simultaneously enhance     bone-structure. The therapy thus has the potential of preventing fractures and possibly other     long-term effects of primary hyperparathyroidism such as formation of kidney stones, and     coronary calcification. Another objective of this project is to investigate whether the     combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby     de facto cure the disease.   "
19713|NCT03027544|"     This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy     for refractory brain metastases.   "
19714|NCT03027531|"     This study is a randomized controlled trial to test acceptability, feasibility and     preliminary efficacy of an interactive computer-based intervention with individualized     feedback to promote sexual health in adolescents and young adults with assessment of     behavioral and biomarker outcomes.   "
19715|NCT03027518|"     The purpose of this study is to explore the efficacy and feasibility of an integrated,     prescriptive, and trackable wellness intervention combining five wellness elements including     exercise, mindfulness, sleep, social connectedness, and nutrition in Beloit College students.     This program is called WILD 5 Wellness: A 30-Day Intervention. Results for this study will     be quantified through the use of standardized self-report questionnaires administered prior     to and after students complete the WILD 5 program (Group 1) or 30 days of inactive     participation (Group 2), and again approximately 30 days later when the initially inactive     group (Group 2) will have just completed their active participation in the WILD 5 program and     the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their     WILD 5 active portion. Data will be collected to evaluate participants' adherence and     response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected     that this 30-day integrated, prescriptive, and trackable program will be found to be an     efficacious wellness intervention for Beloit College students as compared to the control     (inactive) group of students not participating in the Active program.   "
19781|NCT03026634|"     Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart     failure patients and the presence of sleep-disordered breathing has been associated with     increased mortality. This study is designed to investigate prevalence and dynamics of     sleep-disordered breathing in end-stage heart failure patients pre and post heart     transplantation.   "
19716|NCT03027505|"     MUAC only is a non-inferiority trial with external control carried out between January 2017     and December 2017 in the Yako district (northern region), Burkina Faso.      The objective of this study is to evaluate an integrated protocol for acute malnourished     children without medical complication. The hypotheses of the integrated protocol include :        1. A global treatment of acute malnutrition (moderate and severe) with a single treatment          (RUTF) would improve the functioning of the program through early identification of          acutely malnourished children, while achieving a better coverage and using a single          supply chain.        2. A gradual reduction of RUTF dosage according to a child's MUAC status could          significantly increase the number of children on treatment without increasing overall          RUTF quantity while maintaining similar recovery rates.   "
19717|NCT03027492|"     In the last few years, a new clinical entity has emerged which includes patients who consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named     non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators     suggested the term non-celiac wheat sensitivity (NCWS), because it is not known to date     what component of wheat actually causes the symptoms. The clinical picture of NCWS is     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and very     different extra-intestinal and systemic manifestations (headache, depression, anxiety, 'foggy     mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm     numbness, and anemia). Nowadays, there no data about a possible relationship between     gynaecological disorders and food ingestion and food allergy/intolerance. Therefore, the aims     of the present study are to investigate 1) the prevalence and characteristics of     gynaecological disorders in NCWS patients compared to CD and irritable bowel syndrome (IBS)     controls, and 2) the modification of such disorders in NCWS patients after a gluten     (wheat)-free diet.   "
19718|NCT03027479|"     the aim is to study skeletal muscle metabolism alterations métaboliques associated with     weight loss in women with ovarian and/or endometrial cancer according to BMI.   "
19719|NCT03027466|"     Background:      Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as     a threat if they think it suggests that they are unable to meet the challenges of stopping.     When people feel such a threat to their sense of self-identity, they may get defensive. They     may want to downplay the importance of quitting. This could make them try to quit less.     Self-affirmation is a process of focusing on strengths and values. This can offset threats to     the self and promote healthier behavior.      Objective:      To explore people s values, smoking attitudes, and smoking behavior.      Eligibility:      People ages 18 and older who smoke      Design:      The study takes place entirely on a mobile device.      Participants will give their age, gender, data about their smoking habits, and desired quit     date.      Then they will get different texts about quitting.      Participants will answer follow-up surveys 1 and 3 months later.   "
19720|NCT03027453|"     The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific     Treatments such as endovascular treatment. It will also enable the participating hospitals to     compare the quality of care of their facility. At the same time, B-SPATIAL will provide an     opportunity of scientific evaluation of new therapeutic procedures or specific treatments in     stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous     thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will     allow for an identification of key quality indicators that assure valid quality assessment     aiming at a reduced documentation load for future quality management.   "
19721|NCT03027440|"     Background:      Suicide rates are rising. In 2013, it was the third leading cause of death in children ages     10-14. It was the second leading cause of death for ages 15-24. Many risk factors for suicide     have been found. But it is hard to predict. Evidence is growing that some factors that may     make people vulnerable to suicide can be identified before birth or in early childhood.     Researchers want to study vulnerability to suicide. They want to look at different kinds of     development. These include prenatal, social, behavioral, cognitive, and neurologic. They will     do this by linking data from the United States Collaborate Perinatal Project (CPP) to the     National Death Index (NDI). The CPP data are from about 50,000 children born to mothers who     enrolled in the 1960s. The CPP observed and examined about 60,000 pregnancies. Then it     followed the babies from when they were born through age 7. The CPP collected data on things     like family and medical history, economic status, and behavior. The NDI has data on the date     and cause of death.      Objective:      To link data from the CPP to the NDI in order to study certain precursors to suicide.      Eligibility:      Children born to women who enrolled in the CPP in 1959 1966 and known to be alive at age 7      Design:      Data on children from the CPP will be submitted electronically to the NDI. It will be     encrypted and data from the NDI will be deidentified to protect confidentiality. It will then     be merged with existing CPP data. Researchers will analyze the data.   "
19744|NCT03027115|"     Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist     affects the likelihood of male patients developing post-operative urinary retention following     hernia repair.   "
19722|NCT03027427|"     Background:      Certain stomach cancers are rare, but they have high mortality rates. Researchers want to     learn more about gastric (stomach) tumors. In this study, they want to collect data from     people who have stomach cancer or are at risk to get it. This data will be used to see if the     people can be in other studies.      Objective:      To study tissue from stomach tumors and find people eligible for more studies on gastric     cancer.      Eligibility:      Adults at least 18 years old who have or may have stomach cancer, lesions that may be related     to stomach cancer, or an inherited disorder that leads to stomach cancer.      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Heart tests      Scans or ultrasound.      For the scans, participants lie in a machine that takes pictures. For some scans, they will     swallow or be injected with a small amount of radioactive material. Special cameras will show     the material in the body.      Tumor sample taken with a needle or surgery      Some participants will have an endoscopy. A long, flexible tube with a camera will be     inserted through the mouth into the stomach. The tube will collect tissue from the stomach.      Some participants may have follow-up visits. Some may be invited to join other studies.     Others will be contacted by phone to see how they are doing.   "
19723|NCT03027414|"     Background:      Researchers want to better understand brain processes related to fear and anxiety. They want     to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can     reduce anxiety.      Objective:      To see how TMS affects fear and anxiety through memory and attention tasks.      Eligibility:      Healthy people ages 18-50 who are right-handed      Design:      Participants will be screened through another protocol.      Participants in the pilot study will have 1 visit. This includes:      Urine tests      Questionnaires about mood and thinking      Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will be     shocked to find out what level of shock is uncomfortable but tolerable. They will hear loud,     sudden noises through headphones.      TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they might     receive fake TMS. This feels the same as real TMS. They will perform simple tasks.     Participants in the main study will have 2 visits within 2 weeks.      The first visit includes:      Urine tests      Questionnaires about mood and thinking      MRI: Participants lie on a table that slides into a scanner. They will be in the scanner     about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.      The second visit includes:      Shock and startle workup      TMS   "
19724|NCT03027401|"     Background:      Saliva, blood, tissue, and cancer contain DNA. DNA makes the instruction book for the cells     in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want     to test DNA of people with tumors. They want to look for genetic changes in tumors that could     be targets for treatment. Because DNA can change as cancer changes, more testing may be done     at different times.      Objectives:      To find the DNA changes in cancer that may help guide treatment. To collect samples and data     to be used in future studies.      Eligibility:      People any age with cancer or a pre-cancerous tumor      Design:        -  Participants will be screened with a medical history, physical exam, and blood tests.          Participants will give a sample of their tumor. This is usually from a previous          procedure. Participants will give a saliva or blood sample. They cannot eat, drink,          smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon          of saliva into a tube.        -  Some participants may have a punch biopsy instead. A small instrument will take a small          piece of skin.        -  Researchers will collect data from participants medical records.        -  Participants will answer questions about their family health history. They will also          answer questions about their views on the study, including possible unexpected results.        -  Extra blood or tissue samples may be taken at other times during the participants          treatment. All samples will be saved in secure ClinOmics freezers to be used in future          studies.        -  Participants will be told by their doctors if any test results affect their health or          their cancer treatment.   "
19725|NCT03027388|"     Background:      The brain is separated from the rest of the blood stream by the blood-brain barrier. This is     like a filter that protects the brain. But is also a challenge when medicines need to get     into the brain. Researchers want to give the new drug LB100 to people before brain tumor     surgery. They will measure how much LB100 is in the blood and how much gets into the brain.     This may help with the use of LB100 to treat brain tumors in the future.      Objective:      To see if LB100 can pass into the brain.      Eligibility:      People at least 18 years old with a brain tumor that requires surgery      Design:      Participants will be screened with:      Physical exam      Medical history      Blood tests      Neurosurgery evaluation      Scans      Heart tests      Tumor sample. This can be from a previous procedure.      Participants will have their brain surgery at the Clinical Center.      Participants will get a dose of the study drug through a plastic tube in a vein for 2 hours     during surgery.      Participants will have blood taken 7 times in the 8 hours after getting the study drug.      Tumor samples will be taken during surgery.      Participants will have a heart test after getting the study drug. Sticky pads on the skin     will measure electrical activity of the heart.      Two weeks after leaving the hospital, participants will have a follow-up visit. They will     have a physical exam and blood tests.      One month after surgery, they will be contacted in person or by phone to see how they are     doing.   "
19726|NCT03027375|"     This trial will assess the efficacy and safety of QSG in CHF.   "
19727|NCT03027362|"     The goals of this study are: 1) to investigate the efficacy of combining ketamine with     intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of     ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to     explore the relationship between any ketamine-induced changes in learning and memory and     duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a     diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen to     pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the     study.   "
19745|NCT03027102|"     This study aims to determine the safety and toxicity of incremental doses of Double Negative     T (DNT) cells in human subjects with high risk acute myeloid leukemia (AML). DNT cells are     mature T lymphocytes that comprise ~1% of white blood cells in humans. Injection of DNTs from     healthy donors has been demonstrated to be effective against AML cells. DNT cells will be     collected from healthy volunteers and injected into patients.   "
19730|NCT03027323|"     Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to     critical levels due to several possible reasons. The medical staff treating the patient will     need to find out the reason for your drop in blood pressure as soon as possible. When     treating low blood pressure, the medical staff typically performs a procedure called central     venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under     the collarbone) by inserting a needle into the vein. By doing this, the medical staff can     measure the pressures in the patient's veins or give medicine to the patient while they are     in the hospital.      The purpose of this study is to compare the time needed to complete CVC using the AxoTrack     device to CVC guided by landmarks on a patient's body. The investigators expect that there     will be a maximum of 30 patients enrolled in this study.   "
19782|NCT03026621|"     The purpose of this study is to determine whether or not 'Restore' lignite extract mineral     supplement impacts the microbiome composition of the mouth and gut. Additionally, participant     urine samples will be examined to determine whether or not 'Restore' mineral supplement     impacts the composition urine biomarkers and toxins.   "
19731|NCT03027310|"     Background:      Researchers have some data on how the brain controls movement and why some people have     tremor. But the causes of tremor are not fully known. Researchers want to study people with     tremor to learn about changes in the brain and possible causes of tremor.      Objective:      To better understand how the brain controls movement, learn more about tremor, and train     movement disorder specialists.      Eligibility:      People ages 18 and older with a diagnosed tremor syndrome      Healthy volunteers ages 18 and older      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Urine tests        -  Clinical rating scales        -  Health questions        -  They may have electromyography (EMG) or accelerometry. Sensors or electrodes taped to          the skin measure movement.      Participation lasts up to 1 year.      Some participants will have a visit to examine their tremor more. They may have rating     scales, EMG, and drawing and writing tests.      Participants will be in 1 or more substudies. These will require up to 7 visits. Visits could     include the following:        -  EMG with accelerometry        -  Small electrodes taped on the body give small electric shocks that stimulate nerves.        -  MRI: Participants lie on a table that slides into a cylinder that takes pictures of the          body while they do simple tasks.        -  Small electrodes on the scalp record brain waves.        -  A cone with detectors on the head measures brain activity while participants do tasks.        -  A wire coil held on the scalp gives an electrical current that affects brain activity.        -  Tests for thinking, memory, smell, hearing, or vision        -  Electrodes on the head give a weak electrical current that affects brain activity.        -  Photographs or videos of movement      Participant data may be shared with other researchers.   "
19732|NCT03027284|"     The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in     combination with other anti-cancer agents in Japanese participants with advanced and/or     metastatic cancer.   "
19733|NCT03027258|"     The investigators propose to adopt sustainable community networks (in this case churches) to     implement an integrated community-based screening that incorporates mobile health technology     (mHealth) to make prenatal test results available at the point-of-delivery to guide medical     management.   "
19734|NCT03027245|"     Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective,     multicenter cohort study conducted to characterize and determine the incidence of     eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of     eribulin-induced PN in participants treated with eribulin in a real-life setting for locally     advanced or metastatic breast cancer following one or two prior chemotherapeutic regimens for     advanced disease.   "
19735|NCT03027232|"     The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The     aims of these in vitro studies are to determine the cellular and intracellular mechanisms by     which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.   "
19736|NCT03027219|"     We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in     diabetic patients.   "
19737|NCT03027206|"     Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow     on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive     Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and interventional     study, in which 28 PTNB were randomly divided into two groups: Group 1 submitted to the     vibration technique and Group 2 - to the acceleration of the expiratory flow, both techniques     were applied in an interval of up to ten minutes, for Three consecutive days. The pain     indicators were evaluated according to the PIPP scale in three moments. For statistical     analysis, the Friedman tests and Variance Analysis were applied, the level of significance     adopted was 5%.   "
19738|NCT03027193|"     A phase I dose escalation study to assess the safety and immunogenicity of the candidate     vaccine ChAdOx2 HAV in healthy volunteers.      Volunteers will be recruited and vaccinated in Oxford, England.      All vaccinations will be administered intramuscularly. Three different doses will be tested     (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp).      The total duration of the study will be 52 weeks from the day of enrolment for all     volunteers.   "
19739|NCT03027180|"     Question: What level of noninvasive positive airway pressure is able to expand the lungs of     people with pleural drainage? Design: Cross-sectional, experimental and randomized study.     Participants: Four consecutive people with pleural effusion drained within 24 hours, with     controlled pain and without contraindications to use of noninvasive positive pressure.     Intervention: Each person will be randomly subjected to three levels of noninvasive positive     airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography.     Outcome measures: Lung area.   "
19740|NCT03027167|"     The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical     compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip     arthroplasty.   "
19741|NCT03027154|"     In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases     non-TB participants with lung disease who all meet the standard are divided into different     groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10     and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by     blind method. Specific gama-interferon (γ-IFN) detection is needed before the     injection.Measure the induration and (or) redness of longitudinal diameter size and     transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At     the same time, we observe all kind of adverse events in order to assess the safety of drug.   "
19742|NCT03027141|"     The purpose of the proposed study is to use functional magnetic resonance imaging (fMRI) to     investigate how a change in facial appearance is initially represented in brain circuits and     then alters over time, as the new face becomes recognized as me.      Investigators will try to identify areas of the brain responsible for processing and storing     information about self-facial recognition; Examine how these areas of the brain respond to     images of self and non-self and; Investigate how the brain responds, over time, to     changes in facial recognition, particularly at time points: i) prior to facial injury, ii)     post-injury but prior to facial transplantation, and iii) after receiving facial     transplantation.   "
19743|NCT03027128|"     The purpose of this study is to determine whether haNK™ for Infusion is safe and effective in     the treatment of metastatic or locally advanced solid tumors.   "
19748|NCT03027063|"     This research is being done to determine whether exercise while receiving doxorubicin or     Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this     treatment on the heart and improve other outcomes related to cancer such as tumor markers,     nausea, fatigue and the ability to tolerate chemotherapy.   "
19783|NCT03026608|"     The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce     market on access to healthy food and fruit and vegetable intake in 12 lower-income     communities using a cluster-randomized design.   "
19784|NCT03026595|"     Depression is considered to be the most common neuropsychiatric disturbance of PD. In this     study, investigators will summarize the treatment profile of PD depression to see if PD     depression is properly treated according to guideline.   "
19749|NCT03027050|"     It was aimed to evaluate the contributions of T-PRF treatment combined with open flap     debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis     patients. 29 patients (58 sites) with chronic periodontitis were treated either with     autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG ratio     at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such     as probing depth (PD), relative attachment level (RAL) and gingival margin level (GML) at     baseline and 9 months after surgery were compromised.   "
19750|NCT03027037|"     This study, funded by the John Templeton Foundation, will examine birth and the early     postpartum period (BEPP) as a transformative life experience that may shift women's     experience of emotion in such ways as to a) support enhanced other-oriented emotions and b)     underlie risk or resilience from psychopathology.   "
19751|NCT03027024|"     This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market     clinical follow up study whereby patient undergoing routine cataract surgery will have     bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia)     approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and     secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any     adverse events will be collected.   "
19752|NCT03027011|"     This is a randomized controlled trial designed to test an intervention (Remote ischemic     preconditioning) in patients undergoing carotid endarterectomy (CEA).Remote ischemic     preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple,     cost-free,non-pharmacological and non-invasive strategy.The purpose of this study is to     evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in     patients undergoing carotid endarterectomy compared to control intervention.The outcomes of     interest include neurocognitive function,clinical outcomes,and biomarkers of brain injury.   "
19753|NCT03026998|"     The purpose of this study is to assess the benefit of MR screening for asymptomatic head &     neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients     previously treated by external beam radiation therapy (EBRT).   "
19754|NCT03026985|"     The purpose of this study is to describe the changes in quadriceps muscle size and quality     over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound     imaging. This study will also examine the relationship between those changes and muscle     strength and level of physical function at day 10 and day 20 after ECMO commencement.   "
19755|NCT03026972|"     There are three populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried     (AEC/BC02) phase I clinical research. The clinical study adopt randomized and open research     design.      Population I have 25 subjects who received Tuberculin purified protein derivative(TB-PPD)     skin test and specific gamma-interferon (γ-IFN)detection whose results are both negative     ;Population II have 75 subjects who received Tuberculin purified protein derivative(TB-PPD)     and ESAT6-CFP10 skin test in different arms , specific gamma-interferon (γ-IFN) detection     whose results are all negative.75 subjects whose three kinds of detection results are all     positive(specific gamma interferon detection (γ-IFN),TB-PPD and ESAT6-CFP10 ) are named as     population III. Three populations are screened at the same time.      After filtrating, injecting of population I start firstly.After ensure the safety of the     population I population II and population III carry out the implementation at the same time.   "
19756|NCT03026959|"     There is preliminary empirical support for the use of mindfulness interventions during the     perinatal period; suggesting that mindfulness training may be an effective treatment approach     for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress,     and psychological distress during the postpartum period. To extend on these findings, the     purpose of this research is to evaluate the effectiveness of a brief mindfulness-based     program in protecting maternal mental health and well-being using a randomized controlled     trial.   "
19757|NCT03026946|"     The purpose of this study is to compare the efficacy of alitretinoin and cyclosporine in the     treatment of patients with severe recurrent vesicular hand eczema.   "
19758|NCT03026933|"     To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.   "
19759|NCT03026920|"     It was reported that satisfactory postoperative outcome was difficult to obtain for the     pelvic or acetabular fracture in old people. The less invasive surgical method was conducted     in this study. Then, the clinical results were compared with the patients treated using     traditional methods to assess the less invasive method.   "
19760|NCT03026907|"     The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the     treatment of patients with severe chronic non-hyperkeratotic hand eczema.   "
19761|NCT03026894|"     To investigate the residual ridge resorption at anterior and posterior maxillary and     posterior mandibular ridges among conventional complete dentures and implant overdenture     wearers, and determine its association with the relative occlusal forces distribution,     treatment groups and other patient variables.   "
19762|NCT03026881|"     Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral     selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the     tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and     to see how well this three drugs work together in the treatment of patients with recurrent     and metastatic gastric cancer who progress following first-line therapy. The safety and     efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.   "
19763|NCT03026868|"     The novel plate could be used to manage acetabular fractures involving quadrilateral surface     and posterior column, which may lower the intraoperative blood loss and reduce complication     rate.   "
19764|NCT03026855|"     The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection     in combination with topical application of PRP gel in treating chronic or non-healing ulcers     on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's     bedside.   "
19837|NCT03025906|"     Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency,     evidence-based data to guide initial drug treatment choices are lacking in the Chinese     population. The investigators conduct this prospective randomized controlled trial to     evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and     valproate (VPA) in patients with GCSE.   "
19765|NCT03026842|"     Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients     with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients     with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is     the standard consolidation therapy for these patients with a 5-year overall survival     approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for     consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation,     maintenance therapy is performed with conventional chemotherapy with a 5-year overall     survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and     inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently     needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of     AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine     was also reported by several studies. In this study, the investigators plan to carry out a     prospective, multicenter, randomized, controlled trail to compare decitabine versus     conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results     of this trial may optimize the treatment for AML patients with t(8;21) in the setting of     intermediate dose cytarabine consolidation.   "
19766|NCT03026829|"     The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy     for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a     combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from     Tinnitus (CART) firmware.   "
19767|NCT03026816|"     This study will evaluate a method to optimize parameter settings in epidural spinal cord     stimulation used to recover lower extremity volitional movement. The study will also     characterize improvement in autonomic function (such as blood pressure control) and other     functions related to spinal cord injury.   "
19768|NCT03026803|"     This phase II trial is studying how well giving oxaliplatin and capecitabine together works     in treating patients with liver cancer.   "
19769|NCT03026790|"     Background and significance: Treatment with opioid pain medications (like hydrocodone and     morphine) is common for severe pain, but studies show these medications may not always help     and can cause serious problems. High daily doses of opioids can be especially unsafe. To help     patients with chronic pain have better quality of life and avoid medication toxicity, health     care teams need to manage pain while helping patients reduce opioid medication doses to safer     levels.   "
19770|NCT03026777|"     Endotracheal intubation is common in the care of critically ill patients. Complications of     airway management in this setting are frequently encountered and may be associated with an     increased risk of death. The prevention of complications during urgent and emergent     endotracheal intubation is a key focus for airway management research. Post-intubation     hypotension (PIH), a common complication of endotracheal intubation in the critically ill,     may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but     this approach has not been examined in a prospective trial. There are no randomized trials of     intravenous fluid administration to prevent PIH in critically ill adults. The investigators     propose a randomized trial of fluid loading to prevent PIH in critically ill adults.   "
19771|NCT03026764|"     This study is a pragmatic randomized clinical trial comparing standard inpatient total hip     arthroplasty with same day discharge. Patients who are medically well and have a good support     structure at home will be randomized to inpatient or same day discharge. The investigators     will compare patient costs from the perspective of the Ministry of Health, the institution,     society and the patient. The investigators will also record complications, patient     satisfaction, functional ability and quality of life.   "
19772|NCT03026751|"     10% of the cases referred to the specialist diagnostic haemato-pathology service at RMH are     for cytopenias.      The hypothesis to be tested is that a proportion of patients with idiopathic cytopenias have     mutations in myelodysplasic syndrome (MDS)-associated genes. The investigators will sequence     a panel of known MDS-associated genes in patient material (bone marrow and blood) that is     sent routinely to the diagnostic service where conventional techniques have failed to     establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to     determine their survival, blood counts and development of acute leukaemia and other     haematological malignancies. The clinical outcomes will be correlated with any mutations     detected.   "
19773|NCT03026738|"     Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and     Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of     operative time, intraoperative blood loss , intraoperative organ injury, overall length of     hospital stay, recurrence,and improvement of incontinence and constipation.   "
19774|NCT03026725|"     Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium     phosphate containing pastes may affect the efficacy and postoperative sensitivity associated     with At-Home vital tooth whitening using 20% carbamide peroxide   "
19775|NCT03026712|"     The two cerebral hemispheres find themselves in a state of balanced mutual inhibition. A     stroke with involvement of motor function leads to a reduced excitability in affected     hemisphere M1 and to an increased excitability of contralateral M1. Stroke therefore might     impair interhemispheric balance, leading to a decreased inhibition of contralesional     hemisphere by ipsilesional hemisphere and, in turn, to an increased inhibition of     ipsilesional hemisphere by contralesional hemisphere. Permanence of healthy hemisphere     hyperactivation in chronic phase after stroke is usually index of little functional recovery     and is correlated with a greater ipsilateral structural damage.      Robot-mediated physical therapy is an innovative rehabilitation technique that is effective     in stroke patients. In this study, the investigators will add a non-invasive brain     stimulation protocol with Transcranial stimulation with direct current (tDCS) to the robotic     treatment in chronic stroke patients. tDCS is a non-invasive brain stimulation technique that     is able to modulate cortical excitability. The hypothesis is that dual t-DCS (ipsilesional     excitation and concomitant contralesional inhibition) could restore interhemispheric balance     improving the benefits of robotic therapy with Armeo Power®.   "
19776|NCT03026699|"     The purpose of the study is to learn more about neuro-oncology caregivers' quality of life     and how friends and families help neuro-oncology cancer caregivers at different times during     treatment.   "
19778|NCT03026673|"     Chart review of women who have delivered an infant in a single health care system to     determine if NSAID use increases blood pressures in the postpartum period.   "
19785|NCT03026582|"     Objectives: To assess the predictive value of IUS in children with IBD.      Design: A prospective longitudinal cohort study.      Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's     Hospital.      Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with     either CD or UC.      Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year     follow-up according to therapeutic regimen.      Secondary outcome measures: Correlation of sonographic measures to clinical disease indices,     serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other     radiologic measures performed as part of routine care.   "
19786|NCT03026569|"     This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C,     may contribute to the treatment of patients with chronic hepatitis C.   "
19787|NCT03026556|"     The purpose of this study is to assess the safety and effectiveness of newly initiated     dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in     comparison to newly initiated rivaroxaban users and newly initiated apixaban users   "
19788|NCT03026543|"     This prospective, blinded, randomized clinical trial investigates the effect on postoperative     pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic     cholecystectomy.   "
19789|NCT03026530|"     The purpose of this prospective, blinded, randomized clinical trial is to investigate whether     a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall     postoperative pain and nausea.   "
19790|NCT03026517|"     The purpose of this study is to test whether it is safe to give phenformin with the standard     drug combination of dabrafenib + trametinib. The combination of dabrafenib plus trametinib is     a standard treatment for patients with metastatic melanoma whose melanoma has a mutation in a     gene called BRAF.   "
19791|NCT03026504|"     This study will evaluate the safety and effectiveness of baricitinib in the treatment of     giant cell arteritis. All participants will be taking prednisone at the start of the study.     The prednisone will be reduced according to a standardized tapering schedule while     participants continue to take one tablet of baricitinib daily for 52 weeks.   "
19792|NCT03026491|"     The investigators aim to evaluate chewing function in children with repaired esophageal     atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated     for age, sex, type of atresia. Each child will be required to bite and chew a standardized     biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS).     The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine     the tolerated food texture of children.   "
19793|NCT03026478|"     Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease     characterized by pain and burning sensation. The major types of OLP are the following:     reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains     unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of     autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending     on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely     accepted as the primary treatment of choice.Hence this study is designed to evaluate and     compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05%     in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen     Planus.   "
19794|NCT03026465|"     The objective of the present study is to determine the relation between vascular injury     induced by the stent and strut thickness.   "
19795|NCT03026452|"     To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation     for liver tumors, the investigators used preoperative and postoperative     US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests     including the tumor markers to evaluate the general condition of patients. Intraoperative     US/CEUS/CT would be applied to monitor ablation lesions.   "
19796|NCT03026439|"     The aim of this study is to determine if presence of dyspnea identifies differences in the     6-min walk test performance among smokers with normal or mild spirometric obstruction,     accounting for the confounding effect of heart failure on dyspnea with stress     echocardiography.   "
19797|NCT03026426|"     Background: Depression is a common comorbidity of physical chronic diseases such as diabetes     and/or hypertension and constitutes an important public health problem. It correlates     negatively with the patients' quality of life and self-care, as well as compliance with     medical treatment. In low- and middle-income countries depression often goes unrecognized and     untreated, and there are limited human resources to treat depression and other mental     problems.      Aim: The present study aims to test a 6-week low-intensity psychological intervention (CONEMO     - CONtrol EMOcional) delivered by a smartphone application to people with depressive symptoms     and co-morbid diabetes and/or hypertension recruited in primary health care centers and     public hospitals in Lima, Peru.   "
19798|NCT03026413|"     To compare the efficacy and safety of circumferential pulmonary vein isolation without     contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial     fibrillation.   "
19799|NCT03026400|"     While some studies have suggested that subumbilical and transumbilical incisions have a     similar clinical efficiency and safety, no study has yet evaluated their respective impact on     patient's postoperative aesthetic satisfaction.      The objective of this randomised trial is to compare patient's postoperative aesthetic     satisfaction depending on the type of incision which is performed during surgeries.   "
19829|NCT03026010|"     The aim of the study is to check standard screening blood pressure in the arm and central     blood pressure, the blood pressure at the heart in pregnant women. The standard brachial     pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to     distinguish preeclampsia from other types of hypertension or to predict preeclampsia in those     at risk. Central aortic pressure monitoring has become a valuable clinical tool and     preliminary studies suggest that measuring of central blood pressure may be better predictor     of preeclampsia. It is non invasive and doesn't require undressing. It involves using a     standard blood pressure cuff placed around the thigh, checking carotid pulse and pressure     with an ultrasound and taking measurements of the person neck to torso. With this knowledge     it will be a useful screening tool to identify these patients at higher risk and hopefully     lead to closer monitoring, earlier treatment and reduced morbidity and mortality   "
19800|NCT03026387|"     Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides     (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated     by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime     SA. In addition, SBs are common among young people and are the second leading cause of death     among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of     predictive models. These are currently imprecise and prevent the development of consensual     recommendations for the management of suicidal patients.      Most suicide attempters are evaluated in the emergency room where it is imperative to     identify people with a high risk of relapse. Risk assessment is generally based on the     experience of the practitioner who uses psychometric scales as support for clinical     decisions. This assessment could be improved and supplemented by other sources of     information. Thus, we aim to develop a short and specific tool that combines:        1. Neurocognitive measures carried out using computer software on domains strongly          associated with SB: impulsivity, affective dysregulation, alterations in decision-making          (risky choices), selective attention and verbal fluency.        2. Clinical and psychological assessment including the most predictive items of future SA:          life events (environment) and personality traits (vulnerability). Suicide attempters          will be assessed for SB and suicidal ideation in the emergency department. These          measures will be repeated during a 12-month follow-up. We will use the data obtained to          provide a more accurate measure of risk.   "
19801|NCT03026374|"     Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new     malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with     breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide.     Additionally, 30% of early breast cancer turns metastatic, which is often incurable.     Different from women with early breast cancer, women with metastatic breast cancer(MBC)must     receive lifelong treatment, experience higher levels of emotional/physical distress, and feel     frequent uncertainty about their health/possible death. They are also challenged to manage     distressing adverse effects induced by different adjuvant treatments and experience heavy     self-care demands during the transition period from being a patient to being a survivor.     Thus, specific interventions to help women with metastatic breast cancer to recover from this     traumatic event have been designed, and one of these is supportive-expressive group     therapy(SEGT).SEGT has been found to achieve improvement in anxiety, depression, quality of     life (QoL), family functioning, and satisfaction with treatment. However, the effect of SEGT     on survival is inconsistent. Initial studies examining SEGT have reported a mean survival     advantage of 18 months, however, these findings could not later be replicated.Yet, no study     has reported a survival disadvantage for those given SEGT. In addition, we found no published     articles on the application of SEGT among women with MBC in China. Owing to this dearth of     previous research, it is unclear whether this therapy would exhibit positive effects within     Chinese culture. Thus, we developed a Be Resilient to Breast Cancer(BRBC) program that is     culturally tailored for Chinese females with MBC. This program was adapted from SEGT and is     designed to increase resilience(defined as the capacity to bounce back after encountering a     traumatic event) and QoL, decrease emotional and physical distress(allostatic load), and     eventually prolong longevity. To better adapt to Chinese culture, we added education hosted     by professional staff (e.g., clinical psychologists, dietician, Chinese medicine     practitioner, etc.)in an effort to foster self-efficacy to combat symptoms (such as pain,     fatigue, intrusive thoughts, etc.) through knowledge and technics (such as breath control,     meditation, etc.),and to help patients gain a sense of control in their life. Second, trained     mentors, who were breast cancer survivors themselves, were added to the group discussion to     create non-hierarchical, reciprocal relationships through the sharing of experiences with     those facing similar challenges. These mentors also provided women with first-hand     information about treatment and offered suggestions to combat barriers to recovery.   "
19802|NCT03026361|"     The aim of this study was to examine molecular alterations on the protein level in lesions of     oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) and healthy mucosa. Global     protein profiling methods based on liquid chromatography coupled to mass spectrometry were     used, with a special emphasis on evaluation of deregulated extracellular matrix molecules     expression, as well as on analyses of insulin-like growtg factor 2 (IG2F) and insulin-like     growth factor 2 receptor (IGFR2) expression in healthy mucosa, OLP and OSCC tissues by     comparative semiquantitative immunohistochemistry.      Mass spectrometry based proteomics profiling of healthy mucosa, OLP and OSCC tissues (and     accompanied histologically unaltered tissues, respectively) identified 55 extracellular     matrix proteins. Twenty among identified proteins were common to all groups of samples.     Statistically significant difference between final IGF2 and IGF2R IRS scores in favour to     IGF2R may further corroborate the IG2FR antitumor role in OLP and OSCC where it acts as a     negative regulator of IGF2 activity.   "
19803|NCT03026348|"     This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300     eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into     multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will     be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions     of subjects in various strata will not be pre-specified and the goal will be to achieve an     approximately equal distribution of subjects with these characteristics across the treatment     groups. Serology measures consistent with the study outcomes will be reported.   "
19804|NCT03026335|"     The purpose of the study is to use existing school resources and improve identification,     referral and local support for children that exhibit exposure to childhood trauma resulting     from environmental violence in Belize City. The Ministry of Education has identified the     goals of the project to reduce violent behaviors in primary school children and supporting     those children that have been exposed to violence or other malicious behavior that would     inhibit normal school functioning. In addition, the MOE is supporting additional resources     and data collection for a comprehensive evaluation of student behavior and academic     performance.   "
19805|NCT03026322|"     Complications are common during endotracheal intubation of critically ill adults. Manual     ventilation between induction and intubation (bag-valve-mask ventilation) has been proposed     as a means of preventing hypoxemia, the most common complication of intubation outside the     operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial     comparing manual ventilation between induction and laryngoscopy to no manual ventilation     between induction an laryngoscopy during endotracheal intubation of critically ill adults.     The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary     safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen,     and highest positive end-expiratory pressure in the 24 hours after the procedure.   "
19806|NCT03026309|"     Main objectives: Comparing levels of F-DOPA reuptake rate as an indicator for Dopamine     metabolism of un-medicated Depressed patients to healthy individuals in the Mesocorticolimbic     System (VTA-NAc-PFC) and assessing structural differences between the two groups in the     Hippocampus, Hypothalamic-Pituitary gland and Mesocorticolimbic System (VTA-NAc-PFC) and     resting state fMRI.      Secondary objectives: 1. Comparing the differences of DNA Methylation in the plasma and serum     of patients compared to healthy controls. 2.Assessing the correlation between symptoms'     severity score (evaluated based on Hamilton Rating Scale) at base line and 6 months following     treatmnt to PET 18F-DOPA uptake repertoire in the Mesocorticolimbic System, structural     measurements and DNA Methylation.      Methodology: Study Design: A prospective, pilot study. 30 un medicated Depressed patients and     30 Healthy volunteers will perform a [18F] FDOPA PET/MRI scans following a HAM-D     questionnaire (Hamilton rating scale of depression) and blood tests.      PET-MR (Biograph mMR, Siemens AG, Erlangen, Germany) scans will be performed using the tracer     of dopamine precursor 3,4-dihydroxy-6-[18F]-fluoro-l-phenylalanine ([18F] FDOPA) that     reflects L-dopa transport, L-aromatic amino acid decarboxylase activity, vesicular uptake and     the number of dopamine nerve terminals. Measurements of dynamic F-DOPA parameters (Ki) and     quantitative measurements of static F-DOPA ( SUVmax and SUVmean) will be performed in the     ventral tagmental area (VTA), nucleus accombens (NAc) and pre-frontal cortex (PFC)which     comprise the Mesocorticolimbic System, bilaterally. MRI sequences of T1, T2 3D measurements     (assessing Volume) of the hippocampus, Hypothalamic-Pituitary gland and Mesocorticolimbic     system, DTI measurements in the mesocorticolimbic dopaminergic tract and BOLD (resting-state     f-MRI) in those brain networks. whole genome DNA Methylation from whole blood will be     performed.      To date there is no quantative standard of care evaluation tool that serves psychiatrists     when assigning medication for newly diagnosed depressed patients. The manner in which     medications are assigned are threw symptom evaluation and trial and error. Only a third of     the patients achieve remission after the first line of treatment. SSRI's are most common type     of medication used to treat Major Depression today. One third of patients remains un     responsive even after the fourth line of treatment (of different types of medications). Anti     depression medications way of action requires time to reach its effect and in many patients     with no avail or even causing symptom's severity. The PET-MR multimodality imaging tool     offers a cutting edge technology ideally fitted to measure brain disorders. The use of F-DOPA     radio-ligand with the PET-MR constitutes a novelty in the imaging of the depressed brain.     Dopamine is one of three of the monoamine neurotransmitters targeted by anti-depressive     medication, sharing metabolistic agents. dopamine has been proven to be connected to the     processing of emotion, motivation, hedonism and reward threw its action in the     Meso-cortico-limbic system. Epigenetics is a regulatory system that determines gene     expression. It is heritable in the one hand and reacts to environmental changes on the other.     It has been shown to be involved in psychiatric disorders.      PET-MR scans will be performed. DNA samples will be extracted from subject's whole blood     samples taken prior to scans. Then it will be analyzed for whole genome DNA methylation.     Taken together this novelty imaging technique and epigenetic mapping of peripheral markers     can be used to better understand and personalize anti-depressive treatment compatibility.   "
19827|NCT03026036|"     This study investigates stress-related signaling of glutamate and dopamine within the     reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to     predict depressive symptoms in the future. This will be achieved through various neuroimaging     tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.   "
19828|NCT03026023|"     This is a proof of concept, single center study for the donation of HCV-positive hearts to     HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks     of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon     transplantation.   "
19807|NCT03026296|"     A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service     providing lifestyle support programs for physical activity, smoking cessation and diet, to     inhabitants with increased risk for development of non-communicable diseases. HLCs intention     is to reach physically inactive people who need guidance to get more physically active, and     offer them a lifestyle program for three months or more.      The main aim of this study is to study whether the HLCs, organized according to the Norwegian     Directorate of Health`s guidelines for municipal healthy life centers, affects the     participants short term (3 months) and long term (15 months) physical activity level. Also     changes in diet, tobacco use, health related quality of life, physical fitness,     anthropometry, self-efficacy, motivation, drug use, use of health services and work     participation will be assessed. Secondary aim is to study whether there are any moderators,     such as HLCs capacity, expertise, and collaboration with other services, that have     significance for participants' change. Also it will be studied whether the HLCs result in     larger changes in some subgroups (e.g. socioeconomic) of participants than in others.   "
19830|NCT03025997|"     This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack     to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two     treatments (active, and placebo) on two different days, following a randomized cross-over     design.   "
19808|NCT03026283|"     Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has     high sensitivity and negative predictive value for the detection of coronary artery disease     (CAD). The main limitations of CCTA are its poor specificity and positive predictive value,     as well as its inherent lack of physiologically relevant data on hemodynamic significance of     coronary stenosis, a data that is provided either by non-invasive stress tests such as     myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow     Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard     CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging     (CT-FFR). These techniques correlate well with invasively measured FFR [1-4]. The primary     purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in     triaging chest pain patients in outpatient settings who are found to have obstructive CAD     upon CCTA (> 30% and < 90% stenosis). Invasive FFR and short term clinical outcomes (90 days)     will be correlated with each diagnostic modality in order to evaluate positive and negative     predictive value of each when used incrementally with CCTA.      Patients will undergo a CCTA, as part of routine care. If the patient consents to participate     in the study and is found to have coronary stenosis of 30% to 90%, based on the     cardiologist's reading, the CCTA study will be sent to HeartFlow, a vendor that will provide     a computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis     indicates obstructive disease, the patient will undergo cardiac catheterization with invasive     FFR.      As CCTA utilization increases, the need to train additional imaging specialists will     increase. This study will assess the capability of FFR-CT to enhance performance on both     negative and positive predictive value for less experienced readers by providing feedback     based on CT-FFR evaluation. CCTA readers will be grouped in two categories: those with more     than 10 years reading experience and those with less than 10 years reading experience. Each     CCTA will be read by a less experienced and a more experienced reader. Results from each     reader will be correlated with each other and with the CT-FFR and invasive FFR results.   "
19809|NCT03026270|"     Effect of therapeutical paraffin wax bath in the malleability of burned skin   "
19810|NCT03026257|"     The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses     cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the     control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual     multi-purpose solution (MPS) for cholesterol uptake.   "
19811|NCT03026244|"     Rationale: The immune system in the ageing population becomes compromised with age (termed     Immunosenescence). Therefore, elderly people have a decreased ability to respond to     infection and vaccination. Furthermore, many of the health issues associated with ageing are     linked to inflammation (Inflammaging). It has been suggested that this compromised immune     function is in part due to reduced Toll-like receptor (TLR) function, which is part of the     innate immune system. Milk and dairy based products have been shown to have beneficial     effects on inflammation and immunity. This effect may be mediated via support of the innate     immune response and promotes TLR7 signaling in in vitro assays (unpublished observation).     Also prebiotics have been suggested to influence markers of innate immune function.     Furthermore, TLR function has been suggested to be correlated to vitamin D status. Therefore,     in the current pilot study, the potential of milk protein, prebiotics and vitamin D to     support innate immune function in elderly will be investigated.      Objective: Aim of the current study is to evaluate the effect of milk protein on the innate     immune response in elderly in a pilot study. Furthermore, support of this effect by     prebiotics and Vitamin D will be studied.      Study design: The study will be a double-blind placebo-controlled pilot study. Study     population: Healthy female elderly subjects of 65-85 years of age. Intervention: Period 1:     Milk protein or placebo. Period 2: Milk protein + prebiotics or placebo. Period 3: Milk     protein + prebiotics + Vitamin D or placebo.   "
19812|NCT03026231|"     The purpose of this study is to characterize the intestinal flora in subjects with     Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of     colonic microbiome following fecal microbiota transplantation.   "
19813|NCT03026218|"     A critical variation in the provision of prenatal care to women with GDM is the need to keep     patients engaged with their care between visits by tracking glucose levels using finger     sticks and making dietary and other lifestyle modifications to keep these levels at or close     to normal. Multiple studies have demonstrated that the use of mobile devices can improve     medical outcomes. In order to keep patients engaged between appointments and improve     self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition     therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with     GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give     the user positive feedback and rewards for using the system. This model of group care with     mobile phone monitoring and reminders for women with GDM has not been previously studied. A     randomized control trial is purposed to determine if this approach improves patient care. The     investigators hypothesize that group prenatal care along with inter-session mobile therapy     will increase dietary compliance and therefore reduce the number of individuals requiring     pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care     (GPC) will provide a community foundation to improve learning and increase the motivation of     patients to learn and change. This motivation will be further strengthened by the use of the     GlucoseMama monitoring system which will provide each patient with glucose tracking and     individualized nutritional support.   "
19814|NCT03026205|"     This is a single center study to evaluate the pharmacokinetics of ARMS-I a formulation that     incorporates cetylpyridinium chloride (CPC), administered once as a single dose of three     sprays orally, followed by multiple dosing (3x daily oral sprays) over days 3-6 and then a     repeat pharmacokinetic study during the final oral dose administered as the first dose on day     7 to ascertain CPC accumulation.   "
19815|NCT03026192|"     Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in     preterm infants after completing medical treatment for a hemodynamically significant PDA.   "
19831|NCT03025984|"     Diabetes is a common complication of pregnancy that increases risks for both the mother and     baby. Poorly controlled diabetes has been associated with very large babies, congenital heart     defects, stillbirth, birth trauma, and maternal infections among other complications.     Patients with diabetes in pregnancy require more frequent prenatal visits and fetal     evaluation, and must shoulder the burden of mastering management of a complicated care     regimen. With the ever-expanding world of technology, more healthcare practices are using     cell phones, texting, and social media to interact with patients. Use of this technology has     been successful in management of chronic diseases and as reminder systems. The investigators     propose a randomized clinical trial to investigate patient adherence to recommended care     regimen after intervention of a text message reminder and education system.   "
19832|NCT03025971|"     A prospective, multicenter, nonrandomized, single-arm, controlled target value study,     designed to include no less than 82 patients in at least two (2) clinical centers in China.   "
19833|NCT03025958|"     Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced     Nasopharyngeal Carcinoma   "
19818|NCT03026153|"     Biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic     condition that impairs quality of life as much or more than other major medical conditions.     Biopharmaceuticals are medications which are are isolated from biological sources including     microorganisms, animals or humans. These medications generally function to decrease     inflammation or disrupt the inflammatory cycle. Patients are often apprehensive about     choosing a biologic medication over other options due to anxiety regarding the need for     regular injections, leaving the patient undertreated and continuing to suffer with psoriasis.     Reducing fears of injections may improve adherence to treatment and may improve treatment     outcomes. Fear of injection is inherently subjective and may be easily modified. Anchoring is     the tendency for humans to rely on a specific value when making decisions and to make     judgments relative to that value. Patients who have never taken an injection will     subjectively view the idea of taking an injection relative to the not taking any injection     baseline. This comparison is scary and represents a considerable hurdle to taking a new     injectable medication that may be otherwise optimal for their treatment. Resetting the anchor     may be all that is needed to help patients overcome fear of injection. The objective is to     assess whether patients offered a once monthly injectable biologic would be more likely to     accept that biologic medication if they are first counseled about a daily injection.   "
19819|NCT03026140|"     In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs     of distant metastases will be treated with short-term immunotherapy + COX2-inhibitors. This     treatment will be given during the window period until surgical resection of the tumor. The     duration of treatment will be approximately 6 weeks.   "
19820|NCT03026127|"     The goal of this project is to refine and test a novel emotion-regulation based psychosocial     intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years     old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal     ideation or suicide attempt). Suicide rates in this group are alarmingly high, and reducing     suicide rates in at-risk populations is a major NIMH priority.   "
19821|NCT03026114|"     The TURKHEF registry is the one of the first to include a large sample of patients with HF     from different regions in Turkey. To describe the demographic, clinical, and     echocardiographic characteristics and management of outpatients with Heart Failure (HF)     followed by a representative setting of cardiology centres. Scarce data are available in the     middle-east populations in general and Turkish patients in particular, who have different     etiology, ethnic, cultural backgrounds and risk factors from those patients in the West. The     aim of this study was to study Turkish patients with HF, and define their clinical     characteristics and the signs and symptoms of heart failure, echocardiographic findings and     medications at admission. With this national study, we will evaluate how recommendations of     most recent European guidelines regarding pharmacological and non-pharmacological treatments     are adopted in clinical practice. We will also evaluate the prevalence of the clinical     profiles of patients with HF, according to the definitions proposed by the European Society     of Cardiology, and to investigate their appropriateness in characterizing patients with     different clinical presentations and needs. Assessed outcomes included the causes of     decompensation, use of medications, care quality indicators. Clinical Characteristics and     Management of TURKish Adult Outpatients With HEart Failure (TURKHEF) study aims to     characterize baseline characteristics of patients with heart failure in Turkey.   "
19822|NCT03026101|"     Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males.     Emergency room visits, physician consults, hospitalizations, medications, and indirect costs     such as lost work days and decreased productivity place the global economic burden of     migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone.     Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea,     vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced     functionability, have lost time at work, and 1/3 of patients require bed rest to manage the     symptoms. The health-related impact on quality of life was comparable with that experienced     by patients with congestive heart failure, hypertension, or diabetes.      While the burden of migraines on our society is clear, the pathophysiology of migraines     remains largely unknown. The trigeminovascular system, including the external and internal     carotid arteries and their associated sensory fibers which subserve the head have long been     implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in     1953, was the first to posit that migraine headache pain is the caused by dilation or     circumferential expansion of the extracranial carotid artery. He demonstrated that     migraineurs had twice the pulse amplitude in their external carotid arteries compared to     control subjects and these changes were directly correlated to migraine symptoms. In a 2008     study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20     minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent     dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and     transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels.     Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it is     a selective extracranial vessel constrictor which does not cross the blood brain barrier.      The goal of this current work is to utilize the direct, real-time angiography, which provides     a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who     have migraine headache attacks. This information may guide therapeutic interventions in the     future in order to better treat these migraine patients.   "
19823|NCT03026088|"     This is a single-arm, open label, interventional, multi-center, phase IV pilot study.   "
19824|NCT03026075|"     The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the     performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly     prepared colons.      Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in     the Netherlands).      Subjects who meet the eligibility criteria will be screened for study participation at a     baseline visit(visit 1). Subject who is eligible to the study will required to follow a     specific preparation instruction starting 2 days prior to the colonoscopy with the Motus     Cleansing System (MCS) procedure.      Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and     14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse     Events (AE).   "
19825|NCT03026062|"     The goal of this clinical research study is to test 2 types of dosing schedules of     tremelimumab and durvalumab to learn if one is more effective in patients with high-grade,     platinum-resistant epithelial ovarian, peritoneal, or fallopian tube cancer. The safety of     the dosing schedules will also be studied.      This is an investigational study. Neither durvalumab nor tremelimumab are FDA approved or     commercially available for the types of cancer in this study. They are currently being used     for research purposes only in these diseases. The study doctor can explain how the study     drugs are designed to work.      Up to 115 participants will have screening tests to learn if they are eligible to take part     in this study. Up to 100 participants that are found eligible will be enrolled in this study.     All will take part at MD Anderson.   "
19838|NCT03025893|"     In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib     versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The     investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule,     will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic     properties, inhibit gliomagenesis by inhibition of multiple kinases.   "
19839|NCT03025880|"     Study Design and Treatment:      This is a multicenter phase II trial, with an initial exploratory run-in-phase, to evaluate     the efficacy and safety of pembrolizumab in combination with gemcitabine in patients with     HER2-negative ABC that have previously received anthracyclines and taxanes (unless clinically     contraindicated). In hormone receptor positive patients, previous treatment with 2 or more     lines of hormone therapy will also be required. Patients must have at least one measurable     lesion that can be accurately assessed at baseline and is suitable for repeated assessment by     CT, MRI or plan X-ray. Approximately 53 patients (up to a maximum of 65 patients depending on     the results of the run-in-phase) will be included in this trial.   "
19840|NCT03025867|"     This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.      This program is designed to provide access to niraparib prior to approval by the US Food and     Drug Administration (FDA).      To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete     response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR     or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months     without disease progression after this chemotherapy.   "
19841|NCT03025854|"     The purpose of this clinical research project is to explore potential biomarkers and validate     the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.   "
19842|NCT03025841|"     Pneumonia is the most frequent infection in critically ill patients and remains a significant     challenge to intensivists world-wide due to persisting high mortality and morbidity.     Compelling evidence suggests that appropriate antibiotic therapy remains the most important     intervention to improve patients' outcome, including the administration of a suitable     molecule at an optimized dosage regimen. A vast array of pathophysiological changes can occur     in critically ill patients that can complicate antibiotic dosing. Knowledge of the     pharmacokinetic and pharmacodynamic properties of the antibiotics used for the management of     critically ill patients is essential for selecting the antibiotic dosing regimens, which will     optimize patient outcomes. Changes in volume of distribution (Vd) and clearance (CL) of     antibiotics have been noted in these patients, which may affect the antibiotic concentration     at the target site. It follows that the pharmacodynamic parameters that determine antibiotic     efficacy, which can vary between antibiotic classes, may also be affected. Optimization of     these parameters is necessary to maximize the rate of response through patient recovery and     minimized antibiotic resistance.      In a multicenter observational study in critically ill patients with normal plasma renal     indices at admission, about 65% of patients manifested augmented creatinine clearance on at     least one occasion in the first seven study days. Augmented creatinine clearance may     significantly impact drug pharmacokinetics for a variety of renally eliminated     pharmaceuticals (such as low-molecular weight heparins, aminoglycosides, glycopeptides, and     β-lactams), leading to subtherapeutic concentrations and potentially adverse clinical     outcomes. Currently little data exist that describe the consequences of augmented creatinine     clearance on antibiotics PK.      Ceftaroline (600 mg bid) is a cephalosporin with expanded gram-positive activity, including     MRSA and penicillin-resistant streptococcus, which was approved by the US Food and Drug     Administration (FDA) on October 29, 2010 for the treatment of acute bacterial SSSIs and     community-acquired bacterial pneumonia. Ceftaroline showed also good activity against some of     the common gram-negative respiratory pathogens (eg, Haemophilus influenzae, Moraxella     catarrhalis, Neisseria meningitidis, and Pasteurella multocida). However, it does not display     clinically relevant activity against Pseudomonas aeruginosa, Stenotrophomonas maltophilia, or     Acinetobacter baumannii. Ceftaroline also lacks activity against gram-negative organisms with     extended-spectrum β-lactamases. Importantly, because ceftaroline appears to induce AmpC     β-lactamases despite MIC values in susceptible range, ittheoretically should be avoided in     gram-negative bacteria known to harbor inducible AmpC β-lactamases (eg, Serratia, Proteus,     Citrobacter, Morganella, Enterobacter, Providencia, and P. aeruginosa). In patients,     ceftaroline is given as a prodrug, ceftaroline fosamil. After intravenous administration, the     prodrug is rapidly transformed by plasma phosphatase enzymes to its bioactive metabolite. The     pharmacokinetics of ceftaroline has been evaluated in single and multiple dose studies in     healthy volunteers, in subjects with various degrees of renal impairment and in healthy     elderly subjects. The volume of distribution is equal to 20.3 L, which corresponds to     extracellular fluid volume. The protein binding is low (20%). The main route of elimination     is via renal excretion, with a clearance estimated to160 mL/min close to the creatinine     clearance. The elimination half-live is 2.6 h in adults with normal renal function.     Unfortunately, no PK study has been performed in infected critically ill patients with     augmented creatinine clearance. The best PK-PD index predicting drug efficacy is %Time>CMI. A     bacteriostatic effect is achieved when free drug concentrations exceed the MIC for 30 to 40%     of the dose administration interval (30 to 40%T>MIC). Near maximum organism kill is achieved     at 50 to 60%T>MIC (30%T>MIC for Staphylococcus aureus).      This project aims to characterize ceftaroline PK in patients with early-onset pneumonia and     augmented creatinine clearance. The choice of ceftaroline is justified by its spectrum     suitable for micro-organisms commonly encountered in early onset pneumonia, including     methicillin-resistant Staphylococcus aureus. Secondary main objective is to predict the     probably of reaching PK-PD targets using Monte Carlo simulations under various scenario in     order to identify optimal ceftaroline administration schemes in critical care patients with     various degrees of renal impairment.   "
19843|NCT03025828|"     The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH,     Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous     nephropathy. Acthar is a hormone that stimulates steroid production from small glands above     the kidneys. It has direct protective effects on the kidney and is currently approved by the     FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of     action are not entirely understood and will be studied in the present trial.   "
19844|NCT03025815|"     The purpose of this study is to determine whether oral stimulation program are effective to     improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized     classification of the subjects into to experimental and a control group.   "
19866|NCT03025529|"     The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be     used to help study brain function in healthy people and in those with neurological diseases     like essential tremor. This portion of the study is being done to establish the optimal     methods for stimulating the brain to measure its responses.   "
40548|NCT02754856|"     The goal of this clinical research study is to learn if tremelimumab in combination with     MEDI4736 can help to control colorectal cancer that has spread to the liver. The safety of     these drugs will also be studied.   "
19845|NCT03025802|"     The FAPIC project will develop a diagnostic system that will identify pathogens and     charachterize virulence and resistance. A prospective study will be performed in which blood     samples will be collected of patients with suspected sepsis in order to evaluate the     diagnostic system. In routine care, blood is drawn of these patients for culture in order to     identify the causative pathogen. This process takes 3-5 days. During the study, one extra     blood sample will be collected with the same venipuncture, with each blood culture.     Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the     research laboratories for determination of sensitivity and specificity. The system will not     be used in the clinic.   "
19846|NCT03025789|"     This study evaluates the effectiveness of fexinidazole administered to patients with g-HAT at     all stages of the disease. The aim of the present study is to provide additional information     on the effectiveness and safety of fexinidazole and to assess its use under conditions as     close as possible to those in real life, both in patients treated on an out-patient basis and     in the hospital setting, depending on clinical status   "
19847|NCT03025776|"     To further develop interventions, the investigators need a better understanding of which task     requirements (i.e. size or weight of object, location in workspace, etc.) drive a person     after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts     this relationship. A better understanding of this relationship will promote more informed     development of rehabilitative interventions. This study proposes to explore in people after     stroke: i.) how specific functional tasks requirements relate to 1 vs. 2 handed use, and ii.)     how stroke severity impacts this arm use. We are proposing to study 15 individuals more than     6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour session of     task-related reaching in sitting . The investigators will systematically vary task     requirements (i.e. object size or weight, location in workspace, etc.), and record use of 1     versus 2 hands using videotaping as well as recording of quality of arm movement (kinematics)     and muscle activity (EMG) in both arms.   "
19848|NCT03025763|"     Craniosynostosis (CS) is a common malformation occurring in ~4 per 10,000 live births in     which the sutures between skull bones close too early, causing long-term problems with brain     and skull growth. Infants with CS typically require extensive surgical treatment and may     experience many perioperative complications, including hemorrhage and re-synostosis. Even     with successful surgery, children can experience developmental and learning disabilities or     vision problems. Most often, CS appears as isolated nonsyndromic CS (NSC). Of the several     subtypes of CS, unilateral or bilateral fusion of the coronal suture is the second most     common form of CS accounting for 20-30% of all NSC cases. The etiology of coronal NSC (cNSC)     is not well understood, although the published literature suggests that it is a     multifactorial condition. About 5-14% of coronal craniosynostosis patients have a positive     family history, with a specific genetic etiology identified in >25% of cNSC cases, suggesting     a strong genetic component in the pathogenesis of this birth defect. The causes for cNSC and     its phenotypic heterogeneity remain largely unknown. An international team of investigators     will generate large genomic and gene expression datasets on samples from patients with cNSC.     State-of-the-art imaging, genetic, and developmental and systems biology approaches will be     used to quantitatively model novel pathways and networks involved in the development of cNSC.     Novel variant-, gene- and network-level analyses will be performed on the genomic data     obtained from cNSC cases, their relatives, and controls to identify novel variants and     genetic regions associated with cNCS. Quantitative, analytical, and functional validations of     these predictions will provide insights into the etiology and possible therapeutic targets     for CS and potentially other bone-related disorders.   "
19849|NCT03025750|"     The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled,     multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and     IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.   "
19850|NCT03025737|"     The aim of the present proposal is to investigate the development of distinct morphological,     functional, biochemical and molecular aspects of short- and long-term sport-induced changes     in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The     main goal of our research is to deepen our knowledge on the proper differentiation between     beneficial (physiological) and harmful (pathological) consequences of professional sport,     thereby effectively preventing potential cardiovascular complications of athletes.   "
19851|NCT03025724|"     This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment     of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for     treating SCCis. This study will also secondarily evaluate the tolerability of using     photodynamic therapy for treatment of SCCis.      Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include     lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to     topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light     (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin     cancers in the past year, photosensitizing condition such as lupus, or sensitivity to     porphyrins.      Age, gender, size, and location of the SCCis will be recorded. All subjects will receive     surgical treatment of their SCCis. The control group will undergo a surgical excision of the     tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The     intervention group will receive PDT plus surgical treatment. Photographs of the lesion will     be taken at each study visit. Subjects in the intervention group will then undergo the study     procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to     the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA     incubation and blue light exposure. At 6 months after the last treatment, subjects in the     intervention group will return for clinical follow-up and surgical excision of the lesion.     After excision, the specimen will be sent for processing by pathology and subjects will be     asked to fill out a satisfaction visual analog scale. All slides will be read by a     board-certified dermatopathologist. Side effects will also be monitored using the same graded     scale described previously. Mild adverse events that have been associated with PDT, including     erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation.     These reactions usually occur during or immediately after the PDT treatment.   "
19852|NCT03025711|"     The overall study objective is to evaluate the effectiveness and safety of Trastuzumab     emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and     specifically in patients treated under compassionate use or early access program   "
19862|NCT03025581|"     Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the onset     of regular uterine contractions.      PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to     80% of cases occurring at term. Approximately 90% of patients' experience PROM enter     spontaneous labor within 24 hours, but disagreement exists among health care providers on the     optimal management of women with PROM, particularly the need for and timing of inductions.      Nipple stimulation is a non-medical natural method for induction of labor. Previous studies     demonstrated its effectiveness for initiating labor within 72 hours in women with favorable     cervices. The actual mechanism by which such a technique results in cervical ripening is not     well understood.      In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with     term PROM choosing expectant management.   "
19863|NCT03025568|"     Evaluation of the retention of upper removable partial denture constructed from two different     flexible thermoplastic materials.(BRE-FLEX and PEEK).   "
19853|NCT03025698|"     This is a phase II, open label, multi-center, intra-patient dose escalation study to     characterize the pharmacokinetics after oral administration of eltrombopag in combination     with immunosuppressive therapy in pediatric patients with previously untreated or     relapsed/refractory severe aplastic anemia or recurrent aplastic anemia.      All patients will be treated with eltrombopag for the 26-week Treatment Period, followed by a     52-week Follow-Up Period. Patients who have been previously untreated with immunosuppressive     therapy will be treated according to the standard of care, hATG/cyclosporine, in addition to     eltrombopag. Patients with relapsed/refractory SAA or recurrent AA will be enrolled into one     of two treatment options: hATG/cyclosporine plus eltrombopag or cyclosporine plus     eltrombopag, depending on prior treatment with immunosuppressive therapy.      After initiating treatment with eltrombopag, patients will have their dose assessed and     modified as tolerated, until the targeted platelet count or maximum dose is achieved.     Pharmacokinetic assessments will be performed at time points intended to capture steady state     PK of the starting dose and highest dose achieved.      Upon completion of the Treatment and Follow-Up Periods, all patients will be offered the     opportunity to enroll in an additional 3 year Long Term Follow-Up Period.   "
19854|NCT03025685|"     Adequate support is required for challenging percutaneous coronary interventions (PCI). The     Radial Ultra Support (RUS)technique is a new support technique that provides active     support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right     ventricle-RV) or aorta.   "
19855|NCT03025672|"     Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode     of transmission and its resistance in the environment.      Nosocomiality is defined by the apparition of an infection 48 hours after the patient's     hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted     directly through the hand or from the contaminated environment (during care or not). By     implementing prevention and optimal treatment, nosocomial infections are preventable.      A clostridium difficile infection causes an additional cost of patient care for the hospital.     This additional cost is principally due to the increase of the length of the stay. It varies     according to patient risk factors,and also according to the reason of the hospitalization and     can vary from 300 euros (~317$) to more than 25.000 euros (26.460$).      By determining the increase in the length of the stay and the additional cost due to a     clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut     Catholique de Lille), prevention will be valued and measures against those infections should     be easier to set up.      The main objective of this study is to evaluate the additional cost of an infection by     clostridium difficile.   "
19856|NCT03025659|"     This is a single-center, observational study. Investigators aim to characterize the     metabolism of lactate in children over the first forty-eight hours following cardiac surgery.     Blood samples will be obtained up to 12 timepoints. Samples will be analyzed for     concentration of pyruvate. Results will be compared to standard of care laboratory results     for lactate and other direct and indirect measures of cardiac output.   "
19857|NCT03025646|"     Background (brief):      The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the     estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism Spectrum     Disorder (ASD) have reported higher level of depression than mothers of children with other     developmental disorder and the prevalence of ASD is high in Asian countries. In Bangladesh     16% of adults suffer from depression and a recent study conducted in Bangladesh has     documented a high prevalence of depression among mothers of children with ASD (45%). Mothers     are the life time care givers of children with ASD, and a high burden of depression is likely     negatively impact on the ability of the mothers to provide care to children at home. Mental     health is not addressed in Bangladesh and there is scarcity of qualified providers.      Objectives:      The investigators propose to pilot the feasibility of a package intervention including     implementation of mental health care and home based training program for the mothers of     children with ASD integrated in the regular activities of the special schools that offer ASD     care in Dhaka city in Bangladesh.      Methods:      The study will be conducted in 2 selected special schools over 15 months. In the first stage,     the investigators will set up the study in two schools and identify various stakeholders for     qualitative assessment of the barriers of implementing the intervention at the institutional     level, individual level, family level, provider level, policy maker level and at the level of     the state. Research staff will identify mothers 18 years of age or older who has a child with     ASD between 3 and 17 years of age enrolled in the school. Following consent, data collector     will obtain data and assess current major depressive episode (MDE) of the eligible mothers     following a standard diagnostic tool (SCID-I). All mothers diagnosed as having MDE will be     invited to participate in the intervention (intervention mothers) and the investigators will     assess the performances in children with ASD by applying ASD Diagnostic Check-list (ADCL).      In the second stage, investigators will implement interventions over 4-6 months, including     (a) implementing mental health care services at the selected schools targeting the     intervention mothers, and (b) organizing training sessions of the intervention mothers for     supporting child care at home for enhancing child performances. Every month a psychiatrist     will visit each school for providing necessary advice and treatment to the intervention     mothers or suggest referral to hospital care, if necessary.      One special educator will be deployed at each school who will organize structured training     sessions for educating the intervention mothers by using BCC materials developed and     validated by icddr,b in the local setting. The special educators will conduct multiple group     sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time,     and follow up intervention mothers at home every month for conducting refresher's training,     documenting the need of additional training supports, and linking mother with an ASD expert     for helping mothers taking a decision.      In stage 3, investigators will conduct post intervention qualitative survey with various     stakeholders who would be involved with implementing the intervention and participated in the     baseline qualitative survey. End line assessment will be conducted of current major     depressive episode (MDE) among all mothers and assess the performance of the children of     intervention mothers in order to assess the impact of the training at home.      Outcome measures/variables:      The primary outcome of the study is to assess the feasibility of institutionalizing the     combined intervention of mental health care supports and the home based training program of     the mothers who would be diagnosed as having major current major depressive episode. The     primary outcome will be assessed by obtaining the perspectives of various stakeholders. The     following parameters will be assessed for measuring feasibility of the proposed intervention.      Acceptability, Adaptability, Demands, Practicality, Implementation, Integration      The secondary outcomes will include estimating the impact of the combined interventions on     the prevalence rate of maternal depression (MDE), individual performances of children, and     cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers     of children with ASD become skilled workforces for filling in the gap of the special     educators in resource poor settings, and extension of these services to more children with     ASD.   "
19858|NCT03025633|"     Radiotherapy uses high doses of x-rays directed at tumours to kill them, an unfortunate side     effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged.     Approximately 22% of radiotherapy patients receive treatment to cure prostate cancer. The     technique used requires patients to maintain full bladder and empty bowel because they are     next to the prostate, the aim of radiotherapy planning is to minimise the radiation dose     received to healthy organs and tissues as this will reduce side effects. PEARL is commercial     interactive PC software that shows realistic and functional 3D models of Linac's (machines     that deliver radiotherapy treatment). Using PEARL it's possible to display realistic patient     treatments including how an individual would be laid on a treatment couch and how the machine     will move and sound during treatment. Additionally PEARL provides the opportunity to look     inside the body to view internal anatomy and show where the radiotherapy treatment is     directed.      Information prior to treatment in radiotherapy is normally given verbally one to one. The     investigators believe this information can be more easily understood if PEARL is used in     conjunction with this verbal exchange. PEARL gives visual and audio representation of the     treatment experience, and demonstrates the reasons behind required preparations.      Research aim is to demonstrate patients who receive information using PEARL have greater     understanding, reduced anxiety and reduced radiation dose. This will be tested using two     groups of patients receiving radiotherapy to the prostate. Group A - Verbal information,     Group B - Verbal information and PEARL demonstration. Data collection is via patient     questionnaires and review of Cone Beam Computer Tomography (CBCT) images that are taken prior     to each radiotherapy treatment as standard practice. CBCT's are used to locate the treatment     area and assess bladder and bowel status and ensure all of these are suitable to deliver     treatment accurately.   "
19859|NCT03025620|"     The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential     of an adequate intake of alpha-linolenic acid in elderly.   "
19860|NCT03025607|"     Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical     activity, yet its prevalence continues to rise. This trend may be due in part to low rates of     participation in evidence-based lifestyle change programs such as the Diabetes Prevention     Program (DPP). New strategies are needed to promote healthy behaviors among individuals at     risk for T2DM, and mobile health technologies may be an effective and scalable approach to     achieve this. One promising tool is JOOL Health, a mobile phone-based application that     leverages principles from Self-Determination Theory to help individuals understand how     certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue     their core values and purpose in life. Through personalized messaging and feedback, JOOL     Health aims to increase autonomous motivation, a form of motivation closely associated with     the initiation and maintenance of healthy behaviors.      In this mixed methods pilot randomized controlled trial, the investigators will test whether     the JOOL Health mobile phone-based application -- used alone and in conjunction with other     mobile health technologies to track weight and physical activity -- can increase autonomous     motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who     previously declined participation in a Diabetes Prevention Program (DPP).   "
19861|NCT03025594|"     The aim of this study is to demostrate the eficcacy in pain control management after total     knee arthroplasty of Gonyautoxin. Local administration during surgery of Gonyautoxin before     wound closure can achieved better pain control and lower morphin use during hospital stay     compared to local administration of chirocaine, ketorolac and epinephrine   "
19864|NCT03025555|"     Evaluation the patient satisfaction and dimensional stability of upper removable partial     denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).   "
19865|NCT03025542|"     This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to     investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in     adult subjects with moderate to severe chronic plaque psoriasis   "
19867|NCT03025516|"     This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy     of two TB breath-based technologies independently of the manufacturers. Assay error and     failure rates and device operational characteristics will also be assessed during this study.     Participants will be enrolled in this study in line with FIND sample banking activities.     Results from index tests will not be used to make clinical decisions. Participation in this     study will not alter the standard of care.   "
19868|NCT03025503|"     This study will examine the use of nipple stimulation for cervical ripening in women who     present to the labor and delivery ward after their water has broken but have a     contraindication to prostaglandins.   "
19869|NCT03025490|"     The study sets out to assess whether in the context of nurse administered procedural sedation     in the electrophysiology suite, the routine use of capnography and Integrated Pulmonary Index     results in lower incidence of severe adverse respiratory events.   "
19870|NCT03025477|"     CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian     advanced cancer.   "
19871|NCT03025464|"     Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace     currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA     screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA     screening tool would allow greater screening of at-risk individuals, especially in     underserved communities with low socioeconomic status, hopefully encouraging a greater     proportion of such individuals to seek treatment for their condition. Over the past year,     this investigative team has engineered a small screening device (Zerify®) for OSA and     obtained preliminary evidence of its efficacy in a clinical population under a     NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a     small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data,     transfer these data to a computer, and detect non-clinical simulated apnea events with a     specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary     psychometric performance data of the screening device in a clinical sample of 52 patients     (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard     polysomnography. Phase II proposal aims to optimize the engineered hardware and associated     OSA algorithms, create a patient companion app and wireless healthcare provider dashboard,     and compare the efficacy of this screening device to the most commonly utilized sleep apnea     screener, the home sleep apnea test (HSAT).   "
19872|NCT03025451|"     Data from participants in Athens CHIP classes from May 2011 to present will be analyzed to     evaluate the differences in outcomes based on: 1) gender, 2) age, 3) whether a household     member participated in the class with them.      Participants had health screens before and after completing the class. The data from the     health screens that will be utilized for comparison will include: body mass index (BMI),     blood pressure, and fasting blood sugar and lipid levels.   "
19894|NCT03025165|"     The purpose of this study is to compare the virological and clinical outcomes of patients     participating in community models of ART delivery to the standard of care in an urban setting     in Zambia.   "
19873|NCT03025438|"     Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint     cytology is difficult due not only to its various cytomorphologic features but also clinical     rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure,     and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not     always present. In order to find clues for cytological diagnosis of angiosarcoma, we     collected cases of hepatic angiosarcoma to study their cytological features. And then     compared these features with those in their histopathological biopsy or resection.   "
19874|NCT03025425|"     An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea     in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure.     Subjects are recruited from the local respiratory ward. The main outcomes are the compliance     of the subjects with the treatment and alleviation of dyspnea during the treatment period.   "
19875|NCT03025412|"     Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite     this, as many as 44 % of achilles tendinopathy patients do not respond to exercise treatment.      Surgery for midportion achilles tendinopathy has for many years been done as an open     procedure. New knowledge resulted in a variety of minimally invasive procedures and the     development of endoscopic surgery.      In this study, the effect of non-open surgery and conservative treatment (physiotherapy and     exercises) will be compared.   "
19876|NCT03025399|"     This study include 384 Participants with diabetic non-proliferative retinopathy      Design Method: Randomized, double blind, placebo controlled and multicenter clinical study.     Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of     tang wang prescription improve degree of retinal microvascular disease of patients with     diabetic non-proliferative retinopathy.   "
19877|NCT03025386|"     A cochlear implant is a device for the rehabilitation of severe to profound hearing loss.     Despite the standardization of surgical procedures and rehabilitation, speech discrimination     performance varied significantly in cochlear implant users and could be improved by early     individualized cares. However, there is no objective method yet to evaluate phonemes     discrimination, especially in infants, which account for more than half of the indications     for implantation. In electroencephalography (EEG), it is possible to highlight the     discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this     work, this study propose to use the MMN as an objective vocal audiometry method to evaluate     the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear     implant users.   "
19878|NCT03025373|"     An observational study will be conducted in the ICU (Intensive care unit) including patients     with heart surgery (< 5 days) and prolonged ICU stay (> 5 days). Patients will receive 5 min     Virtual reality stimulation per day. A modified version of the Oculus Rift VR glasses     (Facebook inc., USA) with stereoscopic vision and stereo sound will be used to present the     virtual world to patients. An integrated eye tracker will measure oculomotor responses that     will be synchronized with the physiological data recording. All participants will undergo     neuropsychological testing after ICU stay, and after a three-months follow-up. Quality of     life prior to the ICU stay will be enquired from relatives. Main outcome variable is the     explorative behaviour (attention). Secondary outcomes are the quality of life and cognitive     functioning.   "
20240|NCT03020628|"     This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose     of this study is to assess the immunogenicity and safety of the quadrivalent cell     culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza     vaccine in children aged 6~35 months.   "
19879|NCT03025360|"     Larotrectinib (LOXO-101) expanded access is for patients with cancer with a NTRK1, NTRK2, or     NTRK3 gene fusion who are ineligible for an ongoing larotrectinib (LOXO-101) clinical trial     or have other considerations that prevent access to larotrectinib (LOXO-101) through an     existing clinical trial. Expanded access is intended to treat individual patients with     different types of cancers with a NTRK gene fusion.   "
19880|NCT03025347|"     Using a database of individuals with FTO genetic data, the study aims to assess the appetite,     energy intake and gut hormone responses to a bout of moderate- to high intensity exercise in     individuals with genetic variations in the FTO gene.   "
19881|NCT03025334|"     Parkinson's disease (PD) has been classically regarded as a movement disorder, so earlier     work has focused on treating motor symptoms only. As PD patients now have longer life     expectancy, the relatively slowly progressing cognitive deficits (compared to their motor     deficits) have become one of the major challenges. Approximately 80% of PD patients     eventually become demented. Therefore cognitive dysfunction is one of the most significant     factors affecting the quality of life of patients with PD. While dementia in Parkinson's     disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and rivastigmine),     their efficacy on mild cognitive impairment found in non-demented PD is questionable.     Alternative approaches have been proposed including transcranial direct current stimulation     (tDCS) but no consensus has been reached. This can be attributed mainly to: (1) imprecise     knowledge of the underlying functional circuitry mediating this disease manifestation and (2)     inter-individual variability. Here, the investigators will utilize a novel personalized     network analysis approach to elucidate on the underlying mechanisms of the effect of tDCS on     cognitive dysfunction in non-demented PD patients.      It has been well documented that the caudate nucleus plays an important role in cognitive     dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic     resonance imaging (fMRI) study, they have shown that the connectivity of the right caudate     nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive     Assessment (MoCA). The investigators hypothesize that tDCS on the left and/or right     dorsolateral prefrontal cortex may restore the functional connectivity of the right caudate     nucleus which may in turn improve patients' cognitive performance.   "
19895|NCT03025152|"     This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving     symptoms and indicators in patients with spleen qi deficiency and radical gastrectomy for     gastric cancer.   "
19964|NCT03024229|"     When the kidneys are perfused on perfusion machines before transplantation, the resistance     parameters as well as the histological score on the pre-implantation biopsy participate in     the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid     could provide additional evidence.   "
19882|NCT03025321|"     Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation     (tDCS) over the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and relapse     risk. However, little is known about the relapse rates in cocaine addiction after tDCS,     despite the need for new treatment interventions to reduce the high relapse rates in cocaine     addiction. The investigators aim to explore the effects of repetitive tDCS in a larger sample     (N=80) of cocaine addicted patients on number of relapse days after three months. In     addition, the underlying working mechanism will be explored (e.g. cognitive control     functioning). Ecological momentary assessment (EMA) will be used to measure relapse, craving     and mood since retrospective self-reports seem to be less reliable in this respect.   "
19883|NCT03025308|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     filgotinib in participants who have completed one of the parent studies of filgotinib in     rheumatoid arthritis (RA).   "
19884|NCT03025295|"     The current study is designed to investigate the difference of plasma orexin A levels between     Dexmedetomidine group and controlled group at emergence time from total intravenous     anesthesia who will undergo elective lumbar surgery.   "
19885|NCT03025282|"     This is an exploratory, single-centre, investigator blinded, randomized, controlled,     intra-individual study, involving subjects with psoriasis vulgaris.      The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the     safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once     daily application.   "
19886|NCT03025269|"     This is a Phase IV, prospective, open-label, single-center, observational, longitudinal,     single blinded study. The investigators will examine the effects of Ocrelizumab on cognitive,     patient reported outcomes (PROs), quality of life (QoL), multiple sclerosis functional     composite (MSFC), working status and magnetic resonance imaging (MRI) outcomes across 12 and     24 months.   "
19887|NCT03025256|"     This clinical research study consists of 2 phases: dose escalation (Phase 1) and dose     expansion (Phase 2).      The goal of Phase 1 of this research study is to find the highest tolerable dose level of     nivolumab that can be given both by intravenous (IV) infusion and intrathecal (IT) injection     to patients with leptomeningeal disease (LMD). IV infusions are given by vein, while IT     injections are given directly into the cerebrospinal fluid (CSF).      The goal of Phase 2 of this research study is to learn if the highest tolerable dose level     combination found during Phase 1 can help to control the disease.      The safety of the drug combination will also be studied in both phases.   "
19888|NCT03025243|"     The purpose of this study is to evaluate the effect of printing layer thickness on accuracy     of computer aided surgical guide   "
19889|NCT03025230|"     Hypothesis The application of intramuscular electrostimulation will be more effectiveness     than the dry needling in myofascial trigger points treatment.      Objetives:      To determine the effectiveness of intramuscular electrostimulation in the treatment of     trigger points of the levator scapula muscle for the improvement of pain in mechanical     cervicalgia.      Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and     active trigger points in levator scapulae muscle, randomly assigned to experimental or     control group.      Intervention: Control group: one session of dry needling in active trigger points;     experimental group: one session of intramuscular stimulation in active trigger points.      Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion     and strength muscle . The measures will be taken before, after and one week after the     interventions.   "
19890|NCT03025217|"     The investigators aim to develop, pilot and evaluate a new Total Lifestyle Coaching (TLC)     program, that will address both information and behavior-change aspects of nutrition     education for patients whose body mass index (BMI) exceeds 25.   "
19977|NCT03024060|"     The purpose of this study is to prove the safety and efficacy of Levulan Kerastick     (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light     delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the     face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.   "
19978|NCT03024047|"     Background:      Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness of     breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may be     lifesaving.      AV-block in younger can be seen along with structural or ischemic heart disease, congenital     heart disease (incl. congenital AV-block) storage disorders, specific muscle diseases,     sarcoidosis, Borrelia infection or drug intoxication. AV-block in younger can also be seen in     conditions, primarily localized to the AV-node without other cardiac disease at diagnosis.      This form of AV-block is often hereditary and can be seen in families where relatives have     another types of heart disease in form of fore example, cardiomyopathy, ion channel disease     or sudden death. The different forms of presentation are due to the same gene mutation being     expressed differently within the same family. Thus, early onset of AV-block (<50 years) may     indicate hereditary AV-conduction disorder but it can also be the first manifestation of     severe ion channel disease or cardiomyopathy.      Denmark has annually over 50 individuals <50 years treated with pacemaker due to advanced     AV-block. There have been no overall figures regarding the causes of advanced AV-block, and     therefore no systematic approach to diagnosing this group of patients. Furthermore, the     prevalence of individuals with a genetic cause of AV-block is unknown and presumably an often     overlooked diagnosis among younger patients with advanced AV-blok. There are no data on     disease progression after diagnosis, and therefore there is no evidence-based knowledge about     how these patients should be followed after diagnosis.      With modern gene technology, a range of new, yet unknown genes with potentially pathogenic     mutations is likely to be identified. Identification of such genes, and the development of a     strategy for systematic approach to diagnose younger patients with AV-block, will enable     presymptomatic genetic screening of relatives and implementation of evidence-based,     preventive treatment with pacemaker and/or medical treatment for heart failure based on a     specific genetic predisposition for development of AV-block with or without heart failure.      Hypotheses:      In a significant proportion of younger patients with advanced AV-block the underlying cause     is unknown.      Objective:      To investigate the prevalence and causes of advanced AV-block in younger patients in Denmark     and describe the current diagnostics.      Method:      The study is a cross sectional study. The patients for this study are identified from Danish     Pacemaker and ICD Register. The investigators will review medical records and obtain clinical     information and test results (see detailed description).      Perspectives:      This study is the first part of a large study of AV-block in younger patients in Denmark. The     overall goal, is to increase knowledge about the causes of and disease progression after the     diagnosis of advanced AV-block in young patients which could lead to a significant     improvement in the treatment of this patient group and may lead to a customized choice of     pacemaker type in the future and perhaps additional medical treatment in this patient group.     This could potentially lead to a reduction in both their morbidity mortality.   "
19891|NCT03025204|"     Approaches and objectives related to the treatment of patients with aggressive periodontitis     are not markedly different compared patients with the chronic form. However, the large bone     loss related to young age in this aggressive form, justify a well-founded strategy, intending     to further stabilization of disease progression. For this, should make use of regenerative     therapies in the advanced stages of treatment. Noteworthy is the use of proteins derived from     the enamel matrix (EMD) in patients with chronic periodontitis, but there is little evidence     about the effects of this material in aggressive periodontitis. Thus, the present study aims     to evaluate the use of EMD in patients with aggressive periodontitis, comparing them to     individuals with chronic periodontitis. Will then be selected 45 subjects, among patients     with generalized chronic periodontitis (GCP) and generalized aggressive periodontitis (GAP),     with one or more intra-bony defects in radiographic examination, with a minimum size of 4 mm     deep and 2 mm horizontal, associated with a probing depth (PD) ≥6mm, to be treated according     to the groups: GAP+OFD (n = 15) GAP patients which will receive open flap debridement;     GAP+OFD/EMD (n=15) GAP patients which will receive open flap debridement and application of     EMD; GCP+OFD/EMD (n=15) GCP patients which will receive open flap debridement and application     of EMD. Clinical evaluations will be performed at baseline, 3, 6 months and 1 year after. At     baseline, 7, 15, 45 days, 3, 6 months and 1 year after will be collect samples of gingival     fluid to detect bone markers by Luminex / MAGpix technology. For the periods baseline, 3, 6     months and 1 year will be collected subgingival biofilm for the detection and quantification     of periodontal pathogens by real-PCR. Will still be carried x-rays on baseline, 6 months and     1 year after, and questionnaires about patient satisfaction and perception of therapy at     baseline, 7 days and 6 months. To compare the parameters evaluated, ANOVA, Tukey, chi-square,     Spearman and Person tests will be used (α = 5%).   "
19892|NCT03025191|"     The purpose of this study is to adapt an existing couples-level HIV prevention intervention     for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among     couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and     acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and     their community-dwelling committed female partners.   "
19893|NCT03025178|"     We previously performed a study to create formula for the optimal insertion depth of left     internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found     that two calculation methods using height and the distance between landmarks (0.11 × height     (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the     most prominent point of the sternal head of the left clavicle, and B was the midpoint of the     perpendicular line drawn between the sternal head of the right clavicle and an imaginary line     between the nipples) were clinically feasible to determine the insertion depth of left     internal jugular vein catheter. In this study, we will compare the actual insertion depth     with the insertion depth determined from above two calculation methods in other 46 infants.   "
19896|NCT03025139|"     This randomized phase III trial studies how well mindfulness meditation or survivorship     education work in improving behavioral symptoms in younger stage 0-III breast cancer     survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help     patients change the way they react to environmental triggers that may cause a negative     reaction. Survivorship education after treatment may reduce stress and improve the well-being     and quality of life of patients with breast cancer. Mindfulness meditation or survivorship     education may help improve the health behaviors of younger breast cancer survivors.   "
19897|NCT03025126|"     Congenital or acquired neurological disorders could lead to consistent motor and cognitive     disabilities. The continuity and persistency of a tailored home rehabilitation protocol after     recovery is crucial to prevent disease aggravation or relapses. The integration of a     web-based new technology in home rehabilitation programme can constitute a functional low     cost resource by offering patients off-line (and on-line) monitoring and by proposing new     motivating ways of rehabilitation through high tech tools such as serious games.   "
19898|NCT03025113|"     The purpose of this study is to evaluate the safety and efficacy of an association with one     anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent     isolated in the treatment of osteomuscular pain in adults.   "
19899|NCT03025100|"     Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes     mobility evaluation. Mobility is a key component of risk stratification. Poor mobility     evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis.     The investigators aim is to propose to determine whether level of mobility during     hospitalization is being used to influence use and duration of VTE prophylaxis among     medically ill hospitalized elders. To achieve this aim, the investigator will collect     prospective observational data to objectively measure inpatient mobility using patient     mounted accelerometers during patient hospital stays.      The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among     those in which the risks of harm may outweigh the benefit. Results from this study will     provide important insights about use of risk assessment, and the relationship between patient     mobility and VTE prophylaxis. These results are critical to understanding how to take the     next steps toward improving the appropriate use and safety of anticoagulants in hospitalized     older adults. Information from this study could be used in future proposals to study     interventions to ultimately improve hospital practice in the care of older adults.   "
19900|NCT03025087|"     The purpose of this study is to determine whether hydroxychloroquine decreases the relative     leakage of the brain barrier after surgery.   "
19901|NCT03025074|"     The purpose of establishing a biorepository is to provide high quality specimens (serum,     plasma, buffy coat and liver tissue) for future researchers who are studying the effects that     fatty liver and viral diseases have on the liver.   "
19913|NCT03024905|"     The purpose of this trial is to establish if several interventions will help women in rural     Tanzania access health care services during pregnancy and at the time of delivery. The     interventions include education about the importance of attending antenatal care visits with     nurses and facility deliveries, a voucher for transport to access the health facility at the     time of delivery, and supplies to be used either at the health facility, or on route if the     women does not make it to the health facility.   "
19979|NCT03024034|"     The purpose of this study is to determine the safety and tolerability of up to 6 different     single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or     female subjects.   "
19980|NCT03024021|"     This study is designed to assess the effect of cerebral oxygen saturation as an early     predictor of neurological outcomes in patients undergoing therapeutic hypothermia after     cardiac arrest   "
19902|NCT03025061|"     Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in     Children With Moderate or Severe Asthma is an observational prospective study in outpatient     clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and     Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR),     Italy.      The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the     level of airway inflammation for different respiratory diseases, especially in children. To     date, there are no data on the within-day and the between-day repeatability of the breath     pattern in healthy children and in children with moderate or severe asthma.      The breath pattern will be analyzed by collecting, for each child, three samples of the     breath through the E-nose. Within-day repeatability will be assessed using two consecutive     measurements (the second one after 30 minutes). Between-day repeatability will be assessed     using a third measurement repeated after 7 days.      The study is expected to provide information about the accuracy of E-nose measurements for a     child population.   "
19903|NCT03025048|"     People with spinal cord injury are at increased risk for overweight and obesity, type 2     diabetes, cardiovascular disease and decreased quality of life compared With able bodied.      This pilot aims to assess the impact of a nutrition intervention that combines several     methods to help people change their lifestyle.      The pilot project combines individual interviews and personal lifestyle goals (diet) with     group classes for people with long-standing spinal cord injury.      In addition to nutrition theory and practical exercises for diet-planning, motivational     interviewing and mindfullness are incorporated into the course. The course is     interdisciplinary, but is led primarily by a dietitian. Data is collected before the course     starts and right after the 9-week course ends. The measurements involves self-perceived     quality of life, food diary, weight, waist circumference and body composition (measured by     BIA and DXA).   "
19904|NCT03025035|"     This trial will evaluate the use of immunotherapy in a population with incurable advanced     breast cancer associated with a germline BRCA mutation. The main objective is to examine     overall response rate of pembrolizumab (immunotherapy) single agent therapy in advanced     BRCA-mutated breast cancer.   "
19905|NCT03025022|"     The objective of this study is to evaluate the absorption, distribution, metabolism, and     excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40     milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability     will also be assessed.   "
19907|NCT03024996|"     This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to     evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who     are at high risk of disease recurrence following nephrectomy.   "
19908|NCT03024983|"     Carbohydrate-based products can influence the post-prandial glycemic response differently     based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta     is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature     describe a lower glycemic response after the consumption of pasta compared with other     wheat-based products, such as bread. Among the factors affecting post-prandial glycemia after     consumption of carbohydrate-based products, the technological process represents a central     one.In fact, the different technological processes alter the food matrix which can affect the     post-prandial metabolism of glucose differently. Thus, the present study aims at     investigating the effect induced by the principal steps of the process of pasta production on     the reduction of post-prandial glycemic response (post-prandial glucose, insulin, GLP-1, GIP     plasma concentrations).   "
19909|NCT03024957|"     this work aims to investigate the effect of intrathecal administration of Morphine,     Dexmedetomidine or both in combination on cellular immunity and cytokine production in     patients undergoing major abdominal cancer surgeries.   "
19910|NCT03024944|"     The purpose of this project is to study brain imaging of a substance called tau, which is     found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for     live imaging of tau in the brain. The main goal of this proposal is to study whether diabetes     status (type 2 diabetes [referred to as diabetes] and pre-diabetes, compared with normal     glucose tolerance [NGT]), is associated with increased tau accumulation in the brain, one of     the culprits of Alzheimer's disease, in a community-based group of middle aged     Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau     positron emission tomography (PET) imaging in 30 middle aged Hispanics.   "
19911|NCT03024931|"     Severe burn patients are some of the most challenging critically ill patients with an extreme     and continuous state of physiological stress. Patients tends to stay for a long period of     time in intensive care unit to treat burns as well as dealing with complications that arises     from the initial burns injury. Severe burns patients are notoriously known to loose weight.     The word 'catabolism' is used medically. This theory of catabolism after a trauma was     hypothesised in 1942 by Professor Curthberston and based on animal models. Since this date,     despite medical technological advancement, there has been no research that confirms Professor     Curthberston's theory. Investigators still do not know the exact mechanism by which the body     changes from conserving energy to becoming catabolic. Furthermore, it remains unclear whether     this change in catabolism is necessary to heal from burns injury.      This theoretical catabolism in burns patients is currently treated with nutritional     supplement, use of medications including beta-blockers (suppresses heart rate and decreases     blood pressure) and oxandrolone (formula which is similar to testosterone to build up     muscles).      There are evidences to suggest that increase in weight loss worsens the outcome in burns     injury. Both overfeeding or underfeeding patients can be detrimental. In this research, the     exact changes in metabolic rate will be measured in the first 72 hours of the study using a     calorimetry machine. In addition to the metabolic rate, the response to the heart, liver,     kidneys and hormonal levels will be measured. By looking into these dynamic changes the     investigator will be able to elucidate whether there is a real increase in metabolic rate. If     there is, the investigator would also be able to tell the response of different organs and     whether there are any hormones that could be responsible to inflicting the metabolic changes.   "
19912|NCT03024918|"     This is an observational study in 3 cohorts of monochorionic diamniotic (MCDA) twins. The aim     of the study is to assess whether unequal placental sharing can be predicted in pregnancy and     whether it is predictive of pregnancy outcome.   "
19914|NCT03024892|"     The investigators will collect the pre-operative medical history and arrange physical     examination, life quality evaluation, blood and biochemical test. The Patients with acute     cholecytitis, gallstone or gallbladder polyp without interventional treatment or     cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.     Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In     study group , ICG was give by intra-gallbladder injection or systemic injection, the     cholecystectomy were performed . In control group, no ICG was given and traditional     cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the     ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before     cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was     started from cystic duct in Calot's triangle.Time to gallbladder removed was recorded.     Conversion rate, post-operative morbidity and mortality will be recorded as well .   "
19915|NCT03024879|"     In this study, the investigators aimed at evaluating the role of motilin in the regulation of     food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers     and is significantly increased in obese patients. Its role in food intake regulation might     contribute to the pathogenesis of obesity.   "
19916|NCT03024866|"     This is a retrospective-prospective study design. Patients who completed treatment     approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be     identified and any existing data in the patient's record will be collected in addition to     conducting office visits for long-term follow-up.   "
19917|NCT03024853|"     The aim of this study is to analyze the efficacy of several variations of an already     validated Positive Psychology Intervention (PPI) called Best Possible Self, using Information     and Communication Technologies (ICT) in general population. Participants are randomly     assigned to one of 4 conditions: BPS PAST condition, BPS PRESENT condition, BPS FUTURE     condition, and CONTROL condition (daily activities).   "
19918|NCT03024840|"     To study the effect of different anaesthetic methods on pediatric neurocognitive development     and cerebral injury during pediatric living related liver transplantation .   "
19919|NCT03024827|"     This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal     Extract in a small group of children with refractory epileptic encephalopathy. The dosage of     Cannabis Herbal Extract will be gradually increased over a four month time period.   "
19920|NCT03024814|"     The purpose of this study is to determine whether acetaminophen is effective in prevention or     reducing the severity of IVH in premature infants.   "
19921|NCT03024801|"     To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage     repair and evaluating functional recovery of the knee joint in knee cartilage injury     patients.   "
19922|NCT03024788|"     Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence:     determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China   "
19965|NCT03024216|"     The purpose of the study is to compare the safety and tolerability of sequential atezolizumab     followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in     patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously     treated with docetaxel or cabazitaxel.   "
19923|NCT03024775|"     Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal     symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat     allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.     Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine     inhibitors, ATIs) can cause the symptoms, and therefore the term non-celiac wheat     sensitivity (NCWS) has been proposed instead of NCGS. It is believed that this condition is     worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with     high gluten content), and that ancient wheats are better tolerated by NCWS patients than the     modern ones. Therefore, the aim of the study is to determine whether the common belief     regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern     ones is confirmed by scientific data, and to identify the wheat kernel components triggering     this pathology. The availability of wheat materials with opposite characteristics, such as     the period of development (ancient vs. modern), or the technological properties (cultivars     with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides,     will allow to define the role played by these factors. Therefore, the study has two     objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the     inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells     (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control     subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the     previous in vitro studies, showing the highest and the lowest in vitro inflammatory response,     in order to verify their effect in triggering NCWS symptoms.   "
19924|NCT03024762|"     The Active Search for Pediatric HIV/AIDS (ASPA) aims at assessing the acceptability,     feasibility and effectiveness of the targeted provider-initiated-testing and counseling     (tPITC) in comparison with the blanket provider-initiated-testing and counseling (bPITC)     among children and adolescents in Cameroon. The new knowledge generated will inform     programming of more suitable strategies to identify HIV-infected children and adolescents and     this will contribute to reducing the current global gap in HIV treatment among this     subpopulation group.   "
19925|NCT03024749|"     Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex     neurosurgical lesions that are very challenging to manage. Spinal vascular malformations     account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our     understanding of these lesions has dramatically increased thanks to neuroimaging technology     (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities     including conservative observation, endovascular embolization, microsurgical resection,     radiation therapy, and combined therapies have been reported. The treatment for these AVMs     and AVFs depends on their location, the type of malformation, the area of the spine involved,     and the condition of the patient at the time of treatment. Due to the rarity of these spinal     vascular lesions, reports of their management and outcomes have been limited to small series     and case reports. And the rates of obliteration and outcomes are not satisfactory, especially     the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for     the treating neurosurgeon.The purpose of this study is to establish multimodality treatment     mode and evaluate the anatomical cure rate and functional preservation rate.   "
19926|NCT03024736|"     In this retrospective chart review, the investigators plan to analyze the effects of     buprenorphine compared to methadone in opioid-maintained pregnant women. The investigators     will evaluate both maternal and neonatal outcomes, with a primary outcome of infant hospital     length of stay. The investigators will evaluate patients receiving care in a single setting.   "
19954|NCT03024372|"     The purpose of this study is to investigate a promising strategy to improve maturation and     patency rates following creation of AV fistulas and assess whether an anastomosis performed     with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency     than one performed with conventional suturing techniques.   "
19927|NCT03024723|"     The mechanism of Upper airway obstruction (UAO) during anesthesia shares many similarities     with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal     continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway     patent with near 100% success in patients with OSA. Obesity is a major risk factors for     obstructive sleep apnea and obese patients have a higher prevalence of UAO during anesthesia.     The investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients     under anesthesia. The investigators propose to test this hypothesis and determine the     efficacy of nCPAP on maintaining airway patency in obese patients who require general     anesthesia compared with CPAP administering face mask.   "
19928|NCT03024710|"     Infant feeding practices and nutritional status among children is interrelated and link is     well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of     the developing countries which coincide with the period of complimentary feeding (CF). This     prospective randomized trial will be implemented in ongoing health and demographic     surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child     health services area. Area of community health workers (four blocks) will be divided into two     pairs and each pair will be randomly assigned into intervention or control groups. The     eligible and consented mother-infant newborn will be recruited either into an intervention or     control groups based on the areas of the paired block. The mothers and family members of the     intervention area will receive intensive counseling on complementary feeding practices     through community health workers. In total about 360 mother-infant pair will be recruited in     the study for each site. Data on children's anthropometry (weight and lengths), information     on complementary feeding practices and related covariates will be collected through trained     research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting,     underweight, wasting) and complimentary feeding index between intervention and control     groups.   "
19929|NCT03024697|"     In this proposed study, the investigators are looking to conduct a prospective, randomised,     double-blind, non-inferiority trial, to study single-shot pectoral plane (PECs) blocks versus     continuous local anaesthetic infusion analgesia versus a combination of PECs blocks and local     anaesthetic infusion analgesia, when it comes to providing analgesia for most forms of breast     surgery.      Breast surgery is common, and the optimal form of analgesia is currently unknown. Techniques     involving local anaesthetic, such as pectoral plane (PECs) blocks and infusion pumps, are     growing in popularity, as they reduce the amount of opioid medications used. Opioids are     associated with nausea, vomiting, low blood pressure, drowsiness and constipation, and as     such, opioid-sparing analgesic regimens postoperatively are becoming more common. These     regimens will typically involve paracetamol, a NSAID (non-steroidal anti-inflammatory drug),     and a local anaesthetic technique.      Pectoral plane blocks involve a once-off injection of local anaesthetic at two locations     within the chest wall, typically done after the patient undergoes general anaesthesia, but     before the commencement of surgery. Local anaesthetic infusion pumps involve the insertion of     a catheter into the wound at the end of surgery, before the patient emerges from general     anaesthesia, that constantly emit local anaesthetic over a defined period of time. Each     technique is considered extremely safe, and is considered acceptable as a form of pain relief     in patients undergoing breast surgery.      There are no published works comparing pectoral plane blocks with local anaesthetic infusion     pump analgesia, and the investigators see a gap in the knowledge base that can be addressed.     This study will allow efficacy, safety and cost of the three techniques to be compared. The     investigators feel the study design is robust, and statistical analysis based on previously     published works in the area of postoperative analgesia has allowed the study to be powered     appropriately.      Patients undergoing breast surgery are a vulnerable group, and this is recognised via the     provision of a comprehensive Patient Information Leaflet and a commitment to respecting the     process of Informed Consent. The investigators also recognise this is a stressful period in a     woman's life, and the study will be conducted in a sensitive and compassionate manner.      The study has been designed to be prospective, randomised, and double-blinded. The     anaesthetic will be standardised in relation to analgesic and anti-emetic agents     administered, in order to minimise variables. Chronic post-surgical pain is a growing area of     research, and the follow-up telephone interview at 3-months will allow investigation of this.      A Data Record Form will be utilised for data collection, which will subsequently be analysed     statistically. Data will be handled sensitively, securely, and by the minimum number of     researchers. A plan is in place for destruction of data at an appropriate time.      While there will be no direct benefit to participants, including monetary considerations,     this research study will add to the knowledge-base surrounding analgesia for breast surgery.   "
19930|NCT03024684|"     The purpose of this study is to evaluate whether statin could prevent recurrence of     hepatocellular carcinoma after curative treatment   "
19931|NCT03024671|"     The dermatological testing of cosmetic products which are new on the market, or existing     products with novel formulations is common and a useful procedure, yet necessary to alleviate     common irritants and contact allergic reactions. Cosmetic products contain a range of     substances that may be considered as potential irritants or contact allergens. In order to     estimate that risk, cosmetics are tested by applying patch tests.   "
19988|NCT03023917|"     The overall objective of the present study is to examine the effects of umbilical cord     milking at birth in preterm infants to prevent and decrease anemia using a multi-center     prospective randomized controlled trial comparing immediate cord clamping (standard at     present) with umbilical cord milking.   "
24040|NCT02970994|"     This study will evaluate the association of linear growth on neurobehavioural outcome in     preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.   "
19932|NCT03024658|"     Background: Positive end expiratory pressure (PEEP) at the time of induction increases     oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all     cases. Factors affecting the action of PEEP have not been elucidated well and remain     controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been     proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the     basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured     by trans-thoracic echocardiography.      Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA     grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic     bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated     in the study. Thirty patients received no PEEP at the time of induction while other 30     patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at     the time of intubation, 5 min after intubation and 10 min after intubation. Patients were     then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP     or > 30 mm Hg   "
19933|NCT03024645|"     The main goal of the research is to apply and evaluate the web-based preventive intervention     (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's     adherence, dropout), and user's satisfaction. Prior to the randomized controlled trial (RCT),     the investigators will conduct a pilot trial to evaluate the preliminary version of the Be a     Mom program in high-risk women (random assignment to the intervention or to the control     condition).      The RCT will be a three-arm prevention trial. Women who have had a child during the prior     month will be enrolled in the study. A minimum number of 1000 women will be enrolled in the     study. After agreeing to participate in the study, the women will be screened for the     presence of risk factors for PPD and early-onset PPD symptoms (using self-report     questionnaires) by a researcher (licensed psychologist). In case of a negative screen,     women's participation in the study will end. In case of a positive screen (high-risk women),     women will be randomly assigned to one of the conditions: the Be a Mom program, the Be a Mom     program with partner (the partner will be invited to assist the program with the woman), or     the control condition. The sample will be recruited at the maternities of Coimbra University     Hospitals-CHUC, EPE.      Participation in the study will last 11 months. The Be a Mom program will last 5 weeks.     Participants in both conditions will be invited by the researchers via email to complete     baseline, post-intervention and follow-up (4-months and 12-months after childbirth)     assessments. Assessments will include self-report questionnaires to assess several indicators     (e.g., depressive and anxiety symptoms, dyadic adjustment, mother-child bonding, and maternal     confidence), mechanisms that may be involved in the treatment response (e.g., negative     automatic thoughts, psychological flexibility, emotional regulation) and user's acceptability     and satisfaction.   "
19934|NCT03024632|"     This is a retrospective chart review. The purpose is to look at the outcomes for women and     newborns who decided to attempt a trial of labor after 3 or more previous cesarean sections.   "
19935|NCT03024619|"     This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis     (IC) pain, with emphasis placed on exploring the type and severity of pain.   "
19936|NCT03024606|"     The investigators propose an 18-month, randomized, open-label evaluation of the impact of     texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will     be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of     age, are in the preparation stage of change and willing to set a quit date within 30 days and     before 35 weeks gestation, and have a cellular phone that is capable of receiving text     messages. Patients will be randomized to either the texting group or control group. A     baseline carbon monoxide level will be obtained. The patient, regardless of group, will have     the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem     that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy     patches or bupropion free of charge in 2-week intervals. Patients in the intervention group     will receive text messages focused on smoking cessation and pregnancy. Patients will be seen     on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with     the pharmacist, and complete a carbon monoxide exhalation test. These visits will be     continued until the pharmacotherapy course is complete.   "
20438|NCT03018028|"     This trial is conducted in Asia. The aim of this trial is to investigate the dose-response     relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide     versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes     mellitus   "
19937|NCT03024593|"     The purpose of the current study is to examine the effects of health-related internet use on     affect, health anxiety and symptom severity in individuals with pathological levels of health     anxiety. The present randomized controlled study compares an online medical searching     condition with a waiting (i.e. non-searching) condition to manipulate the attentional focus.     After an induction of health anxiety using the Autobiographical Emotional Memory Task the     participants in the searching condition go online and search for subjectively relevant health     information (external focus of attention). Individuals in the waiting (i.e. non-searching)     condition are requested to do nothing and not to distract themselves (internal focus of     attention).   "
19938|NCT03024580|"     This pilot trial evaluates in vivo megestrol acetate (MA) modulation of steroidal receptors     in advanced breast cancer.   "
19939|NCT03024567|"     To perform a randomized, double-blind clinical study on the effects of an increased salt     intake on metabolic, cardiovascular and immunological parameters and the gut microbiota   "
19940|NCT03024554|"     To determine the safety and efficacy of the BMFM® kit in the use for the endovascular     treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of the     aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic MFM®     has CE mark approval for the aortic aneurysm treatment.   "
19966|NCT03024203|"     Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for     individuals with psychosis, however, there is no gold standard method of cognitive     remediation available. Cognitive training refers to the training component of CR in which     people practice computerized exercises that train specific cognitive abilities. There is no     agreed upon approach within the field as to the type of training that is most effective with     some studies, training higher level cognitive abilities, some training perceptual abilities,     and others training general cognitive skills. This study will directly compare two competing     methods of cognitive training on measures of neurophysiology, neurocognition, functional     competence, and real-world functional performance.   "
19989|NCT03023904|"     This phase II trial studies how well nivolumab works in treating patients with stage IV lung     cancer or that has come back after initial treatment who has high mutation loads. Monoclonal     antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain     cells.   "
24041|NCT02970981|"     The purpose of this study is to assess the safety and tolerability of treatment with     Nivolumab in combination with Ipilimumab in subjects with resected Stages IIIB/IIIC/ IV     melanoma.   "
19941|NCT03024541|"     Anticholinergic and sedative drugs are frequently prescribed to older people, despite their     negative impact on older people's physical and cognitive function. To estimate the cumulative     exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index     (DBI) in 2007. The present study aims to complement previous study findings showing higher     DBI values to be associated with physical and cognitive impairment. Most previously conducted     studies of the DBI were either cross-sectional or were longitudinal but with short     follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for     patients with dementia. Finally, relatively little is known about the stability of DBI values     over time. The current project therefore aims to examine (1) longitudinal relationships     between long-term cumulative exposure to anticholinergic and sedative drugs as measured with     the DBI and cognitive and physical function, (2) to examine interaction effects between DBI     exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure     remaining stable, declining, increasing or fluctuating over time. These project aims will be     studied with longitudinal data from eligible participants > 60 years from the LASA study with     participants being followed-up during two decades, and the longitudinal data from the     InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will     be studied. Data will be analysed with generalised linear mixed models and Latent Class     Growth Analysis.   "
19942|NCT03024528|"     Pain experienced by critically ill patients is a major problem affecting nearly 50% of the     patients. Assessing pain in critically ill patients is a challenge even in an intensive care     unit (ICU) with a minimal opioid-based sedation protocol. In patients who are unable to     self-report pain, behavioural scales are used, such as CPOT - Critical Care Pain Observation     Tool.      Aim: The aim of this study was to validate the Polish version of a behavioural pain     assessment method - CPOT in an ICU with a minimal sedation protocol (opioid-based) versus     self-report pain using Numeric rating scale (NRS) in both delirious and non-delirious     patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).      Method: A prospective observational cohort study will include 70 patients. The patients will     be observed during a non-nociceptive procedure (wash of an arm) and a nociceptive procedure     (turning). Patients will be observed 5 minutes before, during, and 15 min after the two     interventions (six assessments). Each CPOT assessment will be carried out by two observers     blinded to each other. To validate the Polish CPOT translation calculations of interrater     reliability, criterion validity and discriminant validity will be performed.   "
19943|NCT03024515|"     Pain is a common symptom that is experienced by patients with advanced cancer. Whilst mild     pain can usually be controlled with simple analgesics, more severe pain may require     initiation of opioid analgesics. The World Health Organization (WHO) has developed a specific     guideline for titration of analgesics. Known as the WHO Pain Ladder, patients who have severe     pain despite non-opioid and weak opioid analgesics are advised to step up to level 3 -     Strong Opioids. Morphine is the most common opioid strong analgesic prescribed in Hong     Kong. To the best of our knowledge, there is no formal opioid pain control guideline     developed for cancer patients in Hong Kong. The prescription practices of various physicians     who treat advance cancer patients, including oncologists and palliative care physicians have     never been audited or standardized.      Furthermore, there are inherent issues with the administration of oral morphine. Currently,     only one fixed concentration is available in a liquid formulation. Patients are known to have     difficulties in receiving the appropriate dose. Accurate measurement of the volume required     is extremely difficult, and many a times patients will report to have spilled the oral     morphine during decanting, or will report that they have not been taking adequate doses     because they are worried that they will decant too much into a spoon or syringe and overdose     themselves.      Oxycodone is a semisynthetic strong opioid analgesic, which has recently been introduced to     Hong Kong. It is formulated as a capsule, and again, 2 preparations (sustained-release     (Oxycontin) and immediate release (Oxycodone IR)) are available. Inherent advantages include     ease of administration; different groups have previously reported less adverse effects and     better treatment compliance. However, to date, there has been no prospective 'head-to-head'     comparison have ever been carried out comparing this with the traditional, well-accepted     methods.      The purpose of this study is to assess whether or not the use of Oxycontin and Oxycodone IR     may be superior to traditional medication choices and schedules in terms of time required for     onset of pain control, the side effect profile, patients' tolerability and compliance to     treatment. Interestingly, through this randomized open-label prospective study, we also aim     to capture information on current opioid prescription practices by clinicians who manage     patients with advanced cancers, which will be useful for us to consider the establishment of     territory-wide treatment guidelines at a later juncture.   "
19944|NCT03024502|"     The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis     standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies     with both propolis gels will be performed in comparison with clotrimazole cream in patients     presenting vulvovaginal candidiasis.   "
19972|NCT03024125|"     This study evaluates the effect of different types of diets (high and normal protein) on lean     and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two     groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8     protein g/body mass/day). The same training will be performed for both groups.   "
19973|NCT03024112|"     The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on     the rate of post-operative pulmonary complications in thoracic surgical patients. The     Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen     treatment, will reduce the incidence of postoperative pulmonary complications, improve     post-operative pulmonary function, and reduce ICU and hospital length of stay.   "
19963|NCT03024242|"     Bivalve vaginal speculum insertion is a basic final step of vaginal examination.     Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow     vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such     cases, the value of vaginoscopy (examination of the vagina without speculum) is evident.     Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal     masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in     girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the     effectiveness and feasibility of using hysteroscopy for exploration of the immature genital     tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic     disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow     vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as     an easy way to gain access to the cervical canal and an important tool with which to diagnose     and treat vaginal lesions.      In practice, we notice leakage of excessive irrigating fluid per vagina with poor     visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution     to improve visualization and success of vaginoscopic surgery. This study aims to test     feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if     compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery     in patients with vaginal or cervical lesions.   "
19945|NCT03024489|"     Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle.     Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many     cancers. Several mechanisms have been described: (i) Amplification or overexpression of     cyclin D1, (ii) Amplification of CDK4, (iii) Activating mutation of CDK4, and (iv) Loss of     the CDK4 inhibitor, p16 (CDKN2A). Human Papilloma Virus (HPV) plays a major role in squamous     cell carcinoma of head and neck (SCCHN) carcinogenesis. It induces many alterations in the     CDK4-Cyclin D-Rb and apoptotic pathways such as up-regulation of p16, loss of Rb and p53     functions. A novel therapy for HPV-negative SCCHN is clearly an unmet medical need.      Palbococlib (PD 0332991) is an orally active, highly selective inhibitor of the CDK4/6 with     ability to block Rb phosphorylation in the low nanomolar range. The most advanced development     is in a treatment of metastatic breast cancer. In addition, palbociclib showed a     radiosensitization property. Since combination of cetuximab and radiation improved PFS and     overall survival (OS) in locally advanced unresectable SCCHN when compared with radiation     alone, these provide a strong rationale to evaluate a combination of palbociclib, cetuximab,     and radiation for locally advanced unresectable SCCHN. Because many genetic alterations in     SCCHN significantly involve in the CDK4-cyclin D-Rb pathway, predictive biomarker(s) of     palbociclib in this combination will be explored.      Thus, the investogators propose a non-randomized, dose escalation, phase I study designed to     determine the maximum tolerated dose (MTD) and toxicity of palbociclib, cetuximab, and IMRT     for locally advanced unresectable SCCHN.   "
19946|NCT03024476|"     BOSS-Trial I is a phase 2 clinical trial with the following objectives;        1. to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world          clinical practice and wireless connection to the main server;        2. to prove the feasibility of the BP management strategy, including the pre-specified BP          range, BP management algorithm, and behavioral; and        3. to gather information for the phase 3 trial including BP variability indices and their          potentials as a treatment guidance.   "
19947|NCT03024463|"     In addition to axillary lymph node (ALN), internal mammary lymph node (IMLN) chain is also     the first-echelon nodal drainage site for metastasis and it provides important prognostic     information in breast cancer patients. However, decision about local treatment of IMLN is     still being made based on ALN status. The 2016 National Comprehensive Cancer Network     Guidelines recommend internal mammary lymph node irradiation for patients with more than 4     positive ALNs (category 1), and strongly consider irradiation for patients with 1 to 3     positive ALNs (category 2A). Therefore, there will be patients in positive ALN subgroup who     just face complications of an unnecessary radiation to IMLN and there will be patients in     negative ALN subgroup who do not receive adjuvant radiation therapy they really need. Thus,     these inclusion criteria of National Comprehensive Cancer Network might lead to     over-treatment and under-treatment. Internal mammary sentinel lymph node biopsy (IM-SLNB)     provides a less invasive method of assessing the IMLN than surgical dissection. However, low     visualization rate of IM-SLN has been a restriction of IM-SLNB. A modified radiotracer     injection technique was established in our previous study. This technique could significantly     improve the IM-SLN detection rate. The investigators have validated the accurate of the     hypothesis and the modified radiotracer injection technique in the previous study.      Recently, the investigators propose that if IM-SLN is the only metastatic lymph node and     there would be no positive node else in IMLN chain, the radiotherapy and its associated     complications could be avoided in these patients. On the other hand, if there is the presence     of metastatic non-sentinel lymph node (NSLN) in IMLN chain after IM-SLNB, it is important to     predict the risk of IM-NSLN metastasis in IM-SLN positive patients. As there is currently no     such model, a predictive model for IM-SLN positive patients to avoid radiotherapy is needed     in this situation. Therefore, a new study will be conducted to verify the issues above.      In the current study, all the participants (18~70 years of age) would have the preoperative     pathology of invasive breast cancer and positive fine-needle aspiration result in their     clinical or ultrasonic suspicious axillary lymph node. 99mTc-labeled sulfur colloid was     injected into the parenchyma under the ultrasound guidance 3 to 18 hours before surgery. Two     syringes of 9.25 to 18.5MBq 99mTc-labeled sulfur colloid in 0.5 to 0.7mL volume were injected     at the 6 and 12 o'clock positions 0.5 to 1.0 cm from areola (about 2.0~4.0 cm from the     nipple). IM-SLNB was performed in all participants with IMSLN visualized on preoperative     lymphoscintigraphy and/or detected by the intra-operative gamma probe. All hotspots in the     internal mammary basin were harvested and intra-operative identification of the IM-SLN was     based on gamma probe detection. The IM-SLN was sectioned along the long axis into two blocks     and all blocks were tested by the frozen section and the touch imprint cytology     intra-operatively. Those participants with positive intra-operative results received IMLN     dissection. Finally, all the IM-SLN blocks and IM-NSLN dissected were assessed     post-operatively by H&E and Cytokeratin 19 stained immunohistochemistry. The conclusion would     be drawn through the results mentioned above.   "
19948|NCT03024450|"     Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric     cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with     clinicopathologic factors remain unclear. The object of the study is to determine whether the     addition of trastuzumab to first-line chemotherapy improves efficacy compared with     chemotherapy alone in HER2 positive AGC.   "
19949|NCT03024437|"     This study will assess the immunomodulatory activity of entinostat in patients with advanced     renal cell carcinoma receiving the PD-L1 inhibitor atezolizumab. The overall hypothesis is     that entinostat will increase the immune response and anti-tumor effect induced by the PD-L1     inhibition by suppressing Treg function. We have chosen renal cell carcinoma that has been     reported to respond to PD1/PD-L 1 inhibition. The schedule of entinostat is based on our     previous experience with this agent. Based on our working hypothesis that low dose HDAC     inhibitors will have a suppressive function on Tregs but not on T effector cells, the     starting dose of entinostat will be 1 mg and will be escalated up to 5 mg rather than the 10     mg dose. The combination also with bevacizumab will provide an effective VEGF inhibition that     may potentiate the immune response and anti-tumor effect induced by atezolizumab. The     proposed dose and schedule for atezolizumab and bevacizumab has been shown to be well     tolerated in prior Phase/I/II studies and is currently tested in a Phase III randomized study     in patients with renal cell carcinoma with sunitinib as a control arm. The highest proposed     dose level for entinostat (5 mg) represents 50% of the recommended Phase II dose for this     compound as a single agent.   "
19950|NCT03024424|"     The goals of this study are:      To assess the impact of genetic testing based on how it alters behaviors, to assess the     utility of serum biomarker measurement in combination with genetic testing, to assess the     utility of genetic counseling in personal analysis of risk for age-related macular     degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal     neovascularization (CNV).   "
19951|NCT03024411|"     Data are lacking regarding the use of music and video games for the management of pain in     labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks     will be approached for participation in the study. Patients will be randomized to a     music/video games group and a non-music/video games group. Those randomized to group with     music/video games will be given an iPod for those purposes.The primary outcome will be the     time for patients to request pain medications after Foley bulb placement. The two groups will     be compared for differences in pain outcomes.   "
19952|NCT03024398|"     Selective lymphadenectomy Sentinel (LSS). This technique is already well established in     breast cancer and melanoma and more recently in vulvar and cervical cancer.      Compared to lymphadenectomy, it has several theoretical advantages:        -  this is a sensitive technique with a detection rate of> 90% and a false negative rate of          <5%.        -  the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin          antibodies, serial sections) are more sensitive than the standard histological analysis          of lymphadenectomy, which allows an improvement in the detection of metastases          (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to          detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in          15% of intermediate-risk patients.        -  it avoids short-term and long-term operative and post-operative morbidity of          lymphadenectomy.      Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric     method coupled with the Technetium 99m isotopic method with an overall detection rate of 78%     [95% CI: 73-84]. The fluorescent green of indocyanine appears to give better results with an     overall detection rate of 94% and a bilateral detection rate of 80%.      It seemed useful to take stock of this technique using this new dye.   "
19953|NCT03024385|"     This model will utilize tools from the IMPLICIT (Interventions to Minimize Preterm and Low     Birth Weight Infant through Continuous Quality Improvement Techniques) Network (collaboration     of academic family medicine providers). The project involves assessing maternal risk     behaviors that significantly affect subsequent birth outcomes: specifically smoking     cessation, maternal depression, family planning and preconception folic acid supplementation     during well child (WCC) visits. There is evidence that screening mothers for depression can     be done at WCC. Data from IMPLCIT network has demonstrated increased screening and referral     rates as well as decreased rates of prematurity. This is the first collaborative effort     between Pediatrics and Family Medicine.   "
19955|NCT03024359|"     Considering the high prevalence of obesity its comorbidities in Brazil and in the world,     different therapeutic measures have been suggested. It is currently known that brown/beige     adipose tissue plays an important role in body weight control and there is strong evidence     that its activity is inversely associated with obesity and metabolic diseases. Recent studies     have shown an important role foods and nutrients in the activation of brown/beige adipose     tissue, almost exclusively in animal models. The benefits of monounsaturated fatty acids to     metabolism have been described in several studies, however, the effects of consuming large     amounts of olive oil in the activity of brown/beige adipose tissue in humans have not been     explored. The aim of the study is to evaluate the impact of the consumption of large amounts     of extra virgin olive oil in the activity of brown/beige adipose tissue in lean and obese     humans. This will be a clinical trial with a total duration of 4 weeks. Obese and controls     (normal weight) participants will undergo a dietary intervention for 4 weeks with extra     virgin olive oil. Before and after the intervention period several data will be collected:     dietary intake and physical activity data, evaluation of brown/beige adipose tissue (with     18F-fluorodeoxyglucose positron emission tomography and magnetic resonance imaging -     PET/RMI), assessment of body composition (DXA), lipid profile and inflammatory markers as     well as hypothalamic inflammation (functional magnetic resonance imaging) and brown adipose     tissue biopsies in a subsample of 20 participants. The data will be expressed as mean and     standard deviation and the variables compared by the Student t test or ANOVA for repeated     measures.   "
19956|NCT03024333|"     This study is aimed to establish and identify the normal pattern of swallowing sounds and     analyze swallowing sounds of different textured foods and viscous liquids in healthy subjects     to provide clinical evidence to update dysphagia patients' food.   "
19957|NCT03024320|"     The study uses a theory-driven eHealth platform and innovative physical activity (PA) program     referred to as movement-to-music (M2M) to deliver a customized, home-based PA intervention     for adults with physical disability (PWD). Participants will be recruited through a large     physical medicine and rehabilitation network of clinics specializing in treating patients     with physical disability. Clinicians and their patients will be cluster randomized to one of     three groups: a) M2M; b) M2M plus social networking (M2Mplus); and c) attention control (AC).     Participants will be followed for 48 weeks to obtain objective measures on physical activity,     fitness and self-reported measures on health at four time points. Participant physicians will     receive information on their patients' progress (i.e., adherence and outcomes) across the     48-week study period. The study will compare the effectiveness of M2M and M2Mplus in     increasing physical activity and adherence compared to the AC group, estimate the     improvements in health of M2M and M2Mplus compared to the AC group, and examine the mediators     and moderators of the hypothesized treatment effect to understand for whom and how the     intervention is effective. This multi-level, scalability study will strengthen our     understanding of the potential benefits of eHealth to eliminate barriers to PA participation     among PWD.   "
19958|NCT03024307|"     This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services     Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The     purpose of this study is to evaluate:        1. rates of medication adherence in the OPCSP program compared with usual care in an          integrated health care system.        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care          in an integrated health care system.   "
19959|NCT03024294|"     The goal of this study is to create a unified SOP for care of subjects undergoing VATS     lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic     centers have created standardized algorithms for the care of their subjects and this enables     the centers to determine which subjects can be placed on an accelerated pathway to discharge     and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in     what may be unnecessary tests to simplify patient care and likely accelerate them towards     safe and more timely discharge from the hospital.   "
19960|NCT03024281|"     Primary objectives:        1. To investigate the prevalence of azole resistance in Aspergillus clinical isolates          collected in participating hospitals in Taiwan        2. To investigate the prevalence of azole resistance in Aspergillus environmental isolates          in Taiwan        3. To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in          Taiwan        4. To investigate the clonality of Aspergillus clinical and environmental isolates in          Taiwan        5. To describe the genetic relationships between local resistant strains with global          strains      Secondary objective:        1. To describe the clinical characteristics and treatment outcome of patients with proven          or probable invasive aspergillosis        2. To evaluate the clinical impact of azole resistance in patients with proven or probable          invasive aspergillosis in a case-control study   "
19961|NCT03024268|"     Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure     caused iatrogenic arterial septal defect (iASD) and the functional changes after     interventional iASD closure in a randomized setting.   "
19962|NCT03024255|"     This study is being conducted to assess the safety and efficacy of 3 concentrations of     BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.   "
19974|NCT03024099|"     The hippotherapy is considered a therapeutic modality that provides numerous benefits in the     rehabilitation process and has often been recommended by doctors for children with cerebral     palsy. Despite being in frank ascent, this therapy still lacks scientific evidence.     Objectives: To analyze and compare the effects of hippotherapy program, often 1 or 2 days a     week in gross motor function, trunk balance and functional performance of children with     cerebral palsy.   "
19975|NCT03024086|"     The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of     Functional Dyspepsia.   "
19976|NCT03024073|"     Patients who underwent presbyopic correction with bilateral bifocal intraocular lenses     implantation are supposed to have sufficient uncorrected vision capacity for activities of     daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is     known that light intensity and temperature has a great impact on near vision capacity.     Primary objective of this study is to identify the optimal task lighting conditions (in terms     of light intensity and temperature) for ADLs that demand near vision acuity for a sample oa     patients who underwent presbyopic correction with bilateral bifocal intraocular lenses     implantation   "
19967|NCT03024190|"     Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a     brain injury leading to limbs weakness and impaired coordination between agonist and     antagonist contraction. PSS leads some physical impairments and functional deficits. The     clinical managements for PSS are stretching and range of motion (ROM) exercises,     antispasticity splint, neuromuscular electrical stimulation, oral medications, local     injection with phenol or botulism, or surgery. Recently, some investigators tried to use     Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in     walking ability and upper extremity function facilitation after stroke.      40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40     patients will be randomly divided into the experimental and control groups. In experimental     group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper     extremity twice daily and regular rehabilitation program for 3 weeks. In the control group     (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily     and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week     post intervention, all patients will receive associated physical examinations, hand function     evaluations, and sonography.   "
19968|NCT03024177|"     This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of     laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in     allogeneic and autologous stem cell transplant subjects. The aim of this study is to evaluate     the effect of vapendavir on laboratory-confirmed HRV upper-respiratory tract infection in     HSCT patients, as measured by viral load changes, worsening of upper respiratory tract     infection (URTI) to lower respiratory tract infection (LRTI), duration of clinical symptoms,     the occurrence of supplemental oxygen use, duration of viral shedding, hospital admission and     duration of hospitalization, incidence of secondary bacterial infection, and mortality rates.     Additionally, the safety and tolerability of vapendavir, and the vapendavir plasma levels     achieved in the HSCT population, and the profile of viral resistance development will also be     assessed.   "
19969|NCT03024164|"     This is a multi-center, prospective,continuous registry study. The investigators will include     3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke     in China. The main purpose of this study is to build the study cohort of young ischemic     stroke patients in China, and to compare the prognosis and stroke recurrence of young     patients with different ischemic stroke subtypes. Secondary objectives are trying to find     biomarkers of stroke recurrence.   "
19970|NCT03024151|"     The goal of this research is to compare the effects on psychological distress between T4 mono     replacement group and T4/T3 combination replacement group after total thyroidectomy in     thyroid cancer patients.        1. Subjects:             -  Psychologically distressed patients, such as depression, anxiety, and fatigue               patient after total thyroidectomy with thyroid cancer are considered for               participation. Screening of distress after total thyroidectomy is used HADS               (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F               (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.        2. Randomization:             -  Using the table of random sampling numbers, patients assign to T4 mono replacement               group or T4/T3 combination replacement group.        3. Evaluation for distress:             -  Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate               change of psychological distress (depression, anxiety, and fatigue). Level of               distress after thyroidectomy will determine using Hospital Anxiety and Depression               Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for               depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.   "
19971|NCT03024138|"     Radiotherapy (combined with chemotherapy) is increasingly applied in the curative treatment     of tumours located in the thoracic region (esophageal cancer, lung cancer, breast cancer, and     (non) Hodgkin lymphoma). Accurate radiotherapy planning and delivery is essential for the     treatment to be effective. However, this accuracy is compromised by tumour and organ motion.     Radiotherapy treatment planning is typically performed on a planning-CT scan recorded several     days prior to commencement of radiotherapy. Inter-fraction set up variations and organ motion     during treatment can lead to differences between the calculated dose distribution on the     planning-CT and the radiation dose actually received by the tumour and normal organs.     Accurate assessment of these effects is essential to determine optimal margins in order to     irradiate the tumour adequately while minimizing the dose to the organs at risk (OARs).      In the near future, patients with esophageal cancer, lung cancer, breast cancer and (non)     Hodgkin lymphoma are excellent candidates for proton beam therapy (PBT), which enables marked     reductions of the radiation dose to the OARs and thus decreasing the risk of radiation     induced cardiac and lung toxicity. However, for PBT using pencil beam scanning (PBS),     knowledge of tumour and organ motion will be even more important. The potential major     advantages of PBS for tumours in the thoracic region are challenged by the respiratory motion     of the tumour, breast, esophagus, diaphragm, heart, stomach, and lungs. Setup errors and     inter- and intra-fraction organ motion cause geometric displacement of the tumours and normal     tissues, which can cause underdosage of the target volumes and overdosage of the organs at     risk. Furthermore, it can result in changes in tissue densities in the beam path, which can     alter the position of the Bragg peaks and lead to distorted dose distributions. If pencil     beam scanning techniques are used to treat moving tumours, there is interplay between the     dynamic pencil beam delivery and target motion. This phenomenon can cause additional     deterioration of the delivered dose distribution, usually manifesting as significant local     under and/or over dosage. It is therefore essential to incorporate motion-related     uncertainties during treatment planning.      The main objective of this study is to evaluate the impact of inter-fraction tumour and organ     motion - while taking into account intra-fraction movements appropriately - on photon and     proton radiotherapy treatment planning in order to yield robust intensity modulated photon     and/or proton treatment plans.      Objective: To evaluate the impact of inter-fraction tumour and organ geometrical dislocation     for moving tumours on photon and proton radiotherapy treatment plans in order to create     robust intensity modulated photon- and/or proton treatment plans.      Study design: Pilot-study (80 patients).      Study population: Patients with esophageal cancer (EC), (non) small cell lung cancer     ((N)SCLC) stage III, breast cancer, or (non) Hodgkin lymphoma who will be treated with     radiotherapy (with or without chemotherapy) with curative intent.      Intervention (if applicable): Not applicable.      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of     clinical target volume), dose to organs at risk (OARs), such as the heart (mean heart dose,     MHD) and the lungs (mean lung dose, MLD).      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat     planning CT scans in treatment position without contrast agents in order to evaluate the     impact of inter-fraction tumour and organ motion.      Furthermore, additional CBCTs are collected after 10 radiotherapy fractions to assess the     intra-fraction motion.      The additional radiation dose of these 3-6 4D-CT's and 10 CBCTs is low (4-6 x 25-30mSv + 10 x     7mSv results in an effective dose < 250mSv) compared to the therapeutic radiation dose     (40-60Gy). The risks are therefore negligible and the burden is low.   "
19981|NCT03024008|"     The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II     as an autologous bone-regenerating graft in the reconstruction of deficient bone in two     clinical indications:        1. Long bone extra-articular comminuted fracture        2. Large bone defect or gap incapable of self-regeneration   "
19982|NCT03023995|"     Over the years, numerous surgical techniques such as free autografts and pedicle grafts have     been introduced to correct gingival recession defects. Combination grafts with either     autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet     concentrates, etc., were developed more recently to correct mucogingival defects. The use of     PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus     floor segmentation during implant placement and on facial plastic surgeries have shown     promising results. However to our knowledge, till this study was completed, no studies have     been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the     treatment of localized gingival recession defects.      Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin     membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and     Class II gingival recession defects.   "
19983|NCT03023982|"     A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves     block) has been described for pain control after thoracic surgery, one of the indications to     perform this method is analgesia for surgeries or procedures involving lateral chest wall   "
19984|NCT03023969|"     Low back pain is very common problem, variable modalities have been introduced to control     such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that     could reduce the herniation disk size and inflammation.   "
19985|NCT03023956|"     From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were     treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck     fractures (SNF), we divided the patients into two groups. All the patients were followed at     least 1 year.   "
19986|NCT03023943|"     The research design will be single group pretest-posttest design. The subject will be     instructed to position the knee joint to a position previously set by the experimenter.     Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep     technique.   "
19987|NCT03023930|"     The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF)     on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP)     treatment with referral for ongoing medication-assisted treatment (MAT) and the (2)     effectiveness of IF on patient engagement in formal addiction treatment at 30 days.   "
19990|NCT03023891|"     This study evaluates the effect of acute administration of oral prednisone in white blood     cells counts and glucose tolerance and the relationship of these measures with changes in     gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene     expression will be study before and after prednisone administration.   "
19991|NCT03023878|"     A phase 2, multicenter, open-label, single arm clinical trial in adult subjects with newly     diagnosed aggressive high-risk DLBCL.   "
19992|NCT03023865|"     The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most     challenging congenital malformations in neonatal surgery. Usually the proximal and distal     segments of the esophagus are too far apart, which leads to primary anastomosis abandoned.     Thus various techniques have been used including Circular and spiral myotomies、Foker and     Kimura elongation and gastrointestinal replacement. They are being widely used but bring more     complications and less effectiveness. And considering about the absence of definite guideline     for the diagnosis and treatment of LGEA worldwide, We prepare to use a preoperative staged     stress function procedure for elongation of the proximal and distal segments, then to obtain     an exact evaluation of the pouch status to achieve an individualized protocol of diagnosis     and treatment utilizing the native esophagus to establish esophageal continuity for patients     with LGEA.   "
19993|NCT03023852|"     The purpose of this study is to assess the rate and extent of absorption of JNJ63623872     following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept     single agent tablet formulations compared to the administration of 2*300 mg JNJ63623872     reference tablets, under fasted conditions in healthy adult participants and to assess the     rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a     single oral dose of 2*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose     combination (FDC) tablet formulation compared to the coadministration of 2*300 mg JNJ63623872     tablets (reference formulation) and 1*75 mg oseltamivir capsule, under fasted conditions in     healthy adult participants.   "
19994|NCT03023839|"     Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes.     There is little information on delirium in injured patients however. This study determined     the incidence and risk factors for delirium in severely injured patients.   "
19995|NCT03023826|"     The purposes of this study are to determine:        -  If there are any differences in the way LY3202626 is handled by the body when taken in          two different forms        -  Whether a high fat meal affects the way the body handles LY3202626        -  How well tolerated LY3202626 is      There are three (3) study periods for all participants. Participants will be admitted to the     clinical research unit (CRU) each period and will be discharged from the CRU following the     completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.      The study will last about 50 days, not including screening.   "
20251|NCT03020485|"     The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose     in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide     important information on the potential health benefits of isomaltulose consumption in Asian     population. It will also reveal how the three main ethnicities in Singapore respond to     isomaltulose and whether the response differs from the Caucasians.   "
19996|NCT03023813|"     The primary objective of this study is to help patients compare the benefits of various     preventive care services, based on their individual risk factors (such as smoking status,     obesity, high blood pressure, high cholesterol, etc.). Tailored decision aids will be     provided to each participant during primary care appointments to facilitate discussion     between the participant and his/her provider regarding prioritizing preventive service     recommendations.   "
19997|NCT03023800|"     Macular schisis associated with macular detachment is a one of the complications of high     myopia. There is controversy in the primary treatment for this situation. This study will     compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting     membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal     detachment associated with macular hole.   "
19998|NCT03023787|"     To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical     pharmacokinetics in healthy volunteers.   "
19999|NCT03023774|"     Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment     of thin endometrium or in women with recurrent implantation failure in ICSI cycles   "
20000|NCT03023761|"     In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain     after irradiation of low level laser therapy   "
20001|NCT03023748|"     This study aims to provide intravenous paritcalcitol treatment for the sick and poor     hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing     vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D     analogs.      The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical     parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular     calcification and stiffness parameters and nutrition status in patients receiving chronic     hemodialysis treatment.   "
20002|NCT03023735|"     The goal of this study is to better understand how clinicians give genetic risk information     to patients from multi-ethnic groups and how patients understand this information and     remember it and act upon it. In addition investigators want to know how to better communicate     with patients about complex health issues across the health literacy divide and communication     gap that exists between doctors and their patients.   "
20003|NCT03023722|"     The primary objective of this study is to:      -Test the activity/response rate per RECIST 1.1 criteria of anetumab ravtansine in patients     with advanced pancreatic cancer who stain for mesothelin expression      The secondary objectives of this study are to:        -  Time to Progression (TTP) defined as time from study treatment to RECIST 1.1          progression, or death (others going off study will be censored)        -  Toxicity in pancreatic cancer patients (at 6.5 mg/kg dose)   "
20004|NCT03023709|"     The investigators collected blood and lymphoid tissues routinely discarded during surgery     from adults after a routine seasonal influenza vaccination to determine how immune memory     develops at the actual site of infection, and how immunization may alter this process.   "
20040|NCT03023241|"     To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial     cystitis (BPS/IC) for diagnosis of this disease.   "
20005|NCT03023696|"     C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression     surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the     deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of     life. Furthermore, about half of patients with C5P present with sensory deficits and/or     intractable pain in addition to the muscle weakness.      Prophylactic bilateral foraminotomy at the C5 level during cervical decompression surgery has     been studied recently with the hope that it will minimize the risk of developing a C5 nerve     root palsy postoperatively. Although the current literature provides some support for this     claim, there are insufficient data establishing this technique as a proven measure to reduce     the incidence of C5P. In the present study, we seek to evaluate the effect of bilateral     foraminotomy on postoperative C5P incidence rates.      Bilateral foraminotomy has been correlated with a reduced risk of developing C5P following     cervical decompression surgery, but an identical foraminotomy procedure has never been     applied in a randomized manner to all qualifying patients in a study. Additionally,     prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the     proposed study, bilateral foraminotomy will be randomized to patients receiving cervical     decompression surgery (laminoplasty, laminectomy, fusion). This is a multicenter randomized     trial, including the following sites: Cleveland Clinic, Columbia University Medical Center,     and University of Southern California Spine Center. Patients undergoing cervical     decompression surgery will be consented and enrolled if they meet the inclusion and exclusion     criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of     prophylactic C5 bilateral foraminotomy during cervical decompression.   "
20006|NCT03023683|"     The purpose of the study is to investigate and compare the human immune response in     epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza     vaccine (LAIV) in adults and in children.   "
20007|NCT03023670|"     The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung     perfusion is maintained solely by the bronchial arterial system   "
20008|NCT03023657|"     Severe brain injuries lead to disorders of consciousness after coma. During this awakening     period, detection of arousal is critical to the adaptation of medical strategy, but global     paralysis, including facial expression, make the clinical assessment very difficult.     Emotional facial expressions are a significant part of this clinical assessment. They are     both a landmark of the internal state of the patient (comfort versus discomfort) and a     landmark of the relational level with his environment. Visible emotional facial expression is     a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely     noticeable and very brief. These micro expressions are usually produced when one tried to     voluntary hide emotional expressions. In this study, we hypothesize that some patients     awakening from coma could still produce microexpression before being able to produce visible     emotional facial expressions. This ability to produce micro-expression could be an early     landmark of relational awakening in severe brain lesions.   "
20021|NCT03023488|"     Aim of this study is to investigate the effects of increased intrarenal pressure during     flexible ureteroscopy on renal blood flow.      Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones     according to European Association of Urology (EAU) guidelines on Urolithiasis will be     included in the study after having signed an informed consent form. The pre- and     post-operative evaluation and management will be performed according to EAU Guidelines on     Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be     performed to patients pre- and post-operatively. The pre-operative Doppler US will be     performed 2 days prior to surgery and the post-operative Doppler US will be performed in the     first 24 hours following surgery. The changes on blood flow in renal artery and arcuate     artery will be recorded.   "
20252|NCT03020472|"     This pilot study will investigate B-cell responses following vaccination with live,     attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples     taken at designated time points before and after vaccination.   "
20009|NCT03023644|"     Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD),     making it the most common birth defect. With recent medical advances, more children with CHD     survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with     CHD. These survivors face challenges in terms of their cognitive and behavioral development.     For many, the limitations affect their academic achievement, social adaption and, ultimately,     their quality of life. Among the most disabling limitations are those that pertain to the     ability to maintain attention, plan and organize activities, regulate emotions, and develop     problem-solving strategies. Collectively, these are referred to as executive functions (EF)     because they are higher-order abilities that enable one to coordinate complex behaviors.     Additionally, impaired EF also underlie mental health disorders. In spite of the abundance of     evidence that children with CHD struggle with EF, there is little to offer them in the way of     evidence-based interventions to prevent or mitigate these problems.      The investigators propose to conduct the first randomized trial to evaluate the efficacy of     an intervention, the Cogmed Working Memory Program, in improving the neurodevelopmental     outcomes of children with critical CHD after infant open-heart surgery. Children who meet     eligibility criteria and who agree to participate will be randomly assigned to an     intervention or control group. Children in the intervention group will complete 25 35-40     minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of     home-based, child-friendly, computerized activities. The control group will receive the     standard of care for children with CHD. Children's scores on EF and related     neurodevelopmental tests will be evaluated before the intervention group completes Cogmed     training, at the conclusion of their training, and 3 months later. The latter assessment will     indicate whether any gains in EF skills of the children in the intervention group are     sustained after training. Parents and teachers will also complete questionnaires about     children's EF, attention, and social behaviors to determine whether training affects     behaviors of the intervention group at home and in school. The investigators will also     identify the medical and surgical characteristics of children who benefit most from Cogmed     training. This information will be helpful in targeting the intervention most efficiently in     the future.   "
20010|NCT03023631|"     The goal of this clinical research study is to learn if Gardasil (the HPV vaccine) can     prevent HPV infection and HPV-related disease when given to blood cancer patients who have     received a stem cell transplant.   "
20011|NCT03023618|"     In this before and after study we will investigate the potential benefit on postoperative     outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has     been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards).     In the postoperative period overall complications, as well as exitus , will be analyzed and     compared with those of a control group underwent the same surgical interventions, with a     standard hemodynamic monitoring.   "
20012|NCT03023605|"     The purpose of this study is to analyze the clinical impact of an educational intervention on     adherence to Clinical Practice Guidelines in an Emergency Department (ED), by using a     standardized training, for improving diagnostic sensibility and reducing unnecessary scans,     adverse effects and stays in the ED.   "
20013|NCT03023592|"     A single-center, self-control, open-label study of efficacy and safety of Iguratimod in     patients with Sjögren's Syndrome   "
20041|NCT03023228|"     A learner-centered diabetes survival skills self-management education program was provided to     adults with uncontrolled diabetes in the hospital and generated preliminary evidence of     impact on medication adherence and a trend toward reduction in hospital and emergency     department admissions.   "
20014|NCT03023579|"     PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM),     and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children     with cerebral palsy (CP).      METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this     study. Each child carried out the SEBT and was assessed by two examiners. To determine     intra-rater reliability, the investigators calculated the intra-class correlation coefficient     (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the     inter-rater reliability.   "
20015|NCT03023566|"     The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in     pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix     Children's Hospital.   "
20016|NCT03023553|"     This study will examine the immune responses to the seasonal influenza vaccine in single     cells of the nasal passages when compared with cells in circulating blood.   "
20017|NCT03023540|"     All randomised patients with Charcot-Marie-Tooth Type 1A (CMT1A) who completed the primary     study CLN-PXT3003-02, i.e. 15-month double-blind treatment with PXT3003 or placebo, will be     eligible to continue in the extension study CLN-PXT3003-03.      Patients randomised to PXT3003 dose 1 or 2 in the primary study (CLN-PXT3003-02) will     continue in the extension study at the same dose, while the patients who received placebo     will be assigned to one of the two active doses by a second randomization at the entry in the     extension study.   "
20018|NCT03023527|"     This is an open-label, non-randomized Phase 1 study evaluating the role of two regimens:      A) Nivolumab in combination with Pomalidomide and low dose dexamethasone and B) Nivolumab +     Elotuzumab + Pomalidomide + dexamethasone in the treatment of relapse or refractory multiple     myeloma patients.      The study will be performed in 10 sites in Spain. First, the MTD for the Nivo-Pom-Dex     combination will be determined using a 3+3 scheme. Once the MTD has been determined both     Regimes (A and B) will be open for full accrual and patients will be included in an     alternating way in both regimes simultaneously. In the case that an unacceptable toxicity was     seen in the Lead-in phase (Nivolumab + Pomalidomide + low dose dexamethasone), the other     phase would not be open.      A safety analysis by an internal review committee will be performed once the first six     patients included in the regimen B have completed the first two cycles.      The main purpose of the study is to analyze the proportion of subjects, with refractory or     relapsed multiple myeloma, receiving the combination Nivo-Pom-dex or Nivo-Pom-dex-Elo     experience one or more haematological and non haematological SAE (grade 3 or higher).      Additionally, other      Research Hypothesis:      The combination of nivolumab with pomalidomide and dexamethasone will demonstrate adequate     safety and tolerability to permit further testing of these combinations in subjects with     multiple myeloma. The addition of elotuzumab to nivolumab, pomalidomide and dexamethasone     will not change the safety profile.      Duration of Study:      The study will remain open for enrolment for 15 months (estimated), or until the planned     total number of 40 subjects is reached if this happens first.      The follow-up of the last recruited patient will be up to 3 years, being the Final analyses     performed 1,5 years after the last patient is included.      Study Population:      Male and female adult patients with Multiple Myeloma in first or subsequent relapses,     previously exposed to both a proteasome inhibitor and a IMID (Lenalidomide). Patients may be     exposed, relapsed or refractory to Lenalidomide.   "
20019|NCT03023514|"     Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to the     success of embryo implantation phase, because it exerts, directly or indirectly, an     immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that     facilitate embryo implantation, and to stimulate the production of local mediators useful for     implantation. This study is a prospective clinical trial and aims to evaluate the     reproductive outcomes of Italian couples following oocyte donation fresh cycles when     receiving per os tablets of lipoic acid. Indeed, the control group had only the standard     treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA     (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the     pregnancy test. If the childbearing occurred, treatment continued until the 8th week of     pregnancy. Primary outcome of the study is the implantation rate while the positive hCG rate,     the clinical pregnancy rate, the miscarriage rate and the live-birth rate are secondary     outcomes .   "
20020|NCT03023501|"     The evidence regarding effects of pain modulator like gabapentin on postoperative pain after     sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative     opioid-sparing properties.This study will highlight the effectiveness of preoperative use of     gabapentin for postoperative pain management in morbidly obese patients.   "
20022|NCT03023475|"     Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the     investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust     GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is     performed in the standard fashion according to the institutional routine. The patients are     randomized preoperatively to one of the devices. The proximal end of the radial artery will     be preserved and deep-frozen for histological assessment. Endothelial integrity will be     investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.   "
20023|NCT03023462|"     One of the most common complications after hernia repair is postoperative and chronic pain.     TAP (transverse abdominis plain) block is a recommended multimodal method of reducing     postoperative pain in laparoscopic and open inguinal hernia repair. The objective of this     study is to determine whether the use of a perioperative echo guided unilateral TAP block has     a superior effect on postoperative pain after laparoscopic inguinal repair compared to the a     Quadratus Lumborum 3 Block with a long acting local anesthetic.   "
20024|NCT03023449|"     This study is a non-randomized, Phase 2 clinical trial designed to measure the cerebral blood     flow (CBF) response to inhaled nitric oxide in acute ischemic stroke patients and healthy     subjects. The monitoring is a 35 minute session during which cerebral hemodynamics will be     monitored with both diffuse correlation spectroscopy (DCS) and transcranial doppler     ultrasonography (TCD) while blood pressure, heart rate, cardiac output, respiratory rate, end     oxygen saturation, and inhaled nitric oxide (NO)/nitrogen dioxide (NO2) concentration, are     continuously monitored.   "
20025|NCT03023436|"     This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined     with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.   "
20026|NCT03023423|"     The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung     cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus     atezolizumab alone.   "
20042|NCT03023215|"     The goal of this behavioral research study is to learn if taking part in guided relaxation     programs helps to reduce anxiety and pain during stereotactic breast biopsy. The study will     also examine whether the guided relaxation programs change brain activity, heart rate, and     blood pressure.   "
20043|NCT03023202|"     This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor     Board, and to track patient outcomes.   "
20027|NCT03023410|"     This study will attempt to draw relationships between the soft-tissue related complications     contributing to early TKA revision and the loading and positional patterns from     intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to     address such soft-tissue abnormalities that may otherwise be unknown during traditional total     knee revision procedures. The utilization of sensors should in theory, help diagnose the     potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an     all component revision. Furthermore, the economic implications from converting a total     revision to a partial revision could have a profound effect to the patient and healthcare     provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible     revision patients who agree to participate will be followed for a period of 12 months     following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011     Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be     collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months     post-procedure. All outcomes will be scored to observe changes from baseline at 12-months.     Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility     and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab     hospitals, PT and home care providers. A quantitative analysis of commercial payer claims /     usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional     revision TKA procedures.   "
20028|NCT03023397|"     The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation     following nasal application of Dermatophagoides farinae (Der f), or house dust mite, extract     in e-cigarette users, cigarette smokers, and non-smokers.   "
20029|NCT03023384|"     Create a network of institutions in developing countries that will perform AML diagnosis,     risk classification, treatment, supportive care and follow-up evaluation according to a     common protocol and will register data using common clinical research forms (CRFs) in a     single database and available on the internet.   "
20030|NCT03023371|"     The aim of this study is to establish a nation-wide cohort study of IgG4-related disease     (IgG4-RD) in China.      Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled     from multi-centers around China. A online database system has been established.      Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese     IgG4-RD patients; the secondary endpoints including the demographic features,laboratory     characteristics, immunological tests, imaging and pathological features, in addition, the     treatment and prognosis of the disease.   "
20031|NCT03023358|"     The prognosis for Peripheral T cell lymphomas (PTCL) remains poor in comparison to B cell     NHL. This is largely due to lower response rates and less durable responses to standard     combination chemotherapy regimens such as CHOP. Whether CDOP plus Chidamide can improve the     prognosis for PTCL.   "
20032|NCT03023345|"     The purpose of this study is to determine if trans-rectal microwave ablation of the index     tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using     MRI-transrectal ultrasound image registration.   "
20033|NCT03023332|"     How do varying levels of participation in selecting self-management interventions (ranging     from no input into the selection to selection based on need or preference) affect health     risks and physical and mental health over time in family caregivers of persons with bipolar     disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2)     education (usual care); 3) self-management intervention based on need (SM-need); or 4)     self-management intervention of their preference (SM-preference).   "
20034|NCT03023319|"     This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in     combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that     can be given without causing severe side effects. This study will also test the safety of     this combination and see what effects (good or bad) it has on participants and their cancer.   "
20075|NCT03022786|"     Explore the unmet needs of patients admitted to the hospital for severely inflamed skin of     the lower legs, often described as 'bilateral cellulitis. These patients usually have     intractable lower extremity edema, stasis dermatitis and sometimes allergic contact     dermatitis rather than an infectious process; readmission is common. Investigators will     create patient and provider education materials to align dermatological, home health, and     other resources and measure reduction in hospital re-admission rate and length of stay.   "
20035|NCT03023306|"     Female patients aged between 20 and 70 years, ASA physical status I-II, and scheduled for     thyroidectomy under general anaesthesia will be enrolled in the study.      Patients will be randomized to the preemptive group to receive an antiemetic regime the day     before surgery or to the intraoperative group to receive the same antiemetic drugs in the     same doses intraoperatively.      In the operating room standard monitoring and a standardized anesthetic technique will be     implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be     recorded immediately after extubation and six hourly thereafter for the first 24 hours. Pain     scores assessed by VAS (verbal analogue scale) will be recorded at the same time points.     Also, if patients received fluids and solid food by mouth.   "
20036|NCT03023293|"     The purpose of this study is to clarify the relationship between n-3 PUFA and irisin in     regulating the glucose metabolism in GDM patients.   "
20037|NCT03023280|"     Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be     present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus     sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard     treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to     concerns of stricture formation. Therefore, the investigators aimed to investigate the effect     of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the treatment     of large symptomatic CIP.   "
20038|NCT03023267|"     The current study will investigate the combination of the two modalities in a mixed-methods     design, in order to provide comprehensive knowledge regarding the effects of family-centered     MT during KC, on premature-infants' autonomic nervous system stability (measured by     parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety     levels; And parents' unique experiences of the intervention. Additionally, the study will     analyze separately mothers and fathers to elucidate similar and different effects   "
20039|NCT03023254|"     To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis   "
20044|NCT03023189|"     Upper digestive bleeding Upper gastrointestinal haemorrhage is a common cause of cirrhosis's     decompensation and is associated with a high mortality rate among cirrhotic patients. Its     leading cause is the rupture of gastro-esophageal varices due to portal hypertension. In     cirrhotic patients, the management of acute gastrointestinal haemorrhage is challenging as     they often present with coagulation (or haemostasis abnormalities) abnormalities such as     hyperfibrinolysis, especially when the cirrhosis is decompensated. Beyond life support     measures, therapeutic modalities of variceal bleeding rely on both endoscopic and     pharmacological interventions. Tranexamic acid (TA) is an antifibrinolytic that may help     control the bleeding in this setting, as it showed an unquestionable benefit in other     indications. TA has previously been studied both in upper gastrointestinal haemorrhage from     any causes and in liver transplantation of cirrhotic patients. However, there is a lack of     data to conclude on its effectiveness (or efficiency) in the early treatment of acute     variceal bleeding in cirrhotic patients.      Investigators hypothesize that, when given early, TA would be beneficial for cirrhotic     patients presenting with acute Upper gastrointestinal haemorrhage , by controlling the     haemorrhage, avoiding rebleeding episodes and reducing mortality within 5 days after its     administration. Moreover, TA could prevent early cirrhosis complications (such as hepatic     encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), could reduce     indications to transjugular portosystemic shunt (TIPS), shorten the length of stay in     intensive care unit and the length of hospitalization, and decrease late relapses and     one-year mortality.   "
20045|NCT03023176|"     This study will investigate markers, mechanisms and define general predictors for     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic     twins.   "
20046|NCT03023163|"     The general population is aging, today 12% of the United States population is older than 65     and it is estimated that by 2020 the number of people in the United States older than 65 will     outnumber children younger than 5. As the general population ages, the spinal cord injury     (SCI) population is also aging and it is estimated that 14% is older than 60. Although     persons with SCI are living longer, life expectancy remains below that of the general     population with cardiovascular and cerebrovascular diseases accounting for more than 25% of     all deaths since 1995. Similar to findings in the general population, BP dysregulation may     impact cognitive function, and investigators reported poorer performance on tasks of memory     and attention processing in hypotensive individuals with SCI compared to a normotensive SCI     cohort. Thus, it is imperative that investigators work to minimize the impact of cognitive     deficits on these aspects of life quality in persons with SCI as they age. Therefore the     goals of this study are: Study 1) to compare cardiovascular, cerebrovascular and cognitive     function and fMRI between older individuals with SCI (50-75 years) and older age-matched     controls and Study 2) to determine 3-5 year longitudinal changes in cardiovascular,     cerebrovascular and cognitive function and fMRI in relatively young individuals with SCI     (28-54 years) compared to relatively young age-matched controls.   "
20047|NCT03023150|"     This study will be the first study to use ischemic preconditioning (IPC) as an intervention     to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which     has been shown to improve regional blood flow, motor neuron excitability and muscle function     in multiple patient groups and in young, healthy subjects. Because IPC targets three     physiological systems which are all affected by stroke, we hypothesize that repeated bouts of     IPC during the first days to months following stroke (when the majority of recovery occurs)     will make traditional rehabilitation strategies more effective.   "
20048|NCT03023137|"     This study is part of a big one aiming to evaluate how lifestyle interventions during     pregnancy affect obstetric results, neonatal metabolism and the intelligence of the offspring     (study not yet completed). Data regarding obstetric and neonatal results were entered in     NCT01409382, but we decided to split results in two for the sake of clarity.      A cohort of women with early pregnancy losses without antiphospholipid antibodies was     selected for two reasons. One is that these women follow strictly the recommendadtions. The     second is that no medication has been shown to increase the rate of take-home babies in women     with early miscarriages who test negative for antiphospholipid antibodies. We decided to     focus on the fibrinolytic system because trophoblast migration and placental vasculogenesis     and angiogenesis depend on plasmin-dependent extracellular matrix remodeling. Plasminogen     activator inhibitor (PAI)-1 inhibits the generation of plasmin. Since both glucose and     insulin increase PAI-1 synthesis, hyperglycemia itself, or by stimulating insulin production,     reduces plasmin generation, which may impair placentation.      Abnormalities in glucose metabolism may be also deleterious to embryos by causing epigenetic     changes. Chromosomal abnormalities are considered an important cause of early pregnancy     losses.      Several lines of evidence lend support to the hypothesis that carbohydrate metabolism     abnormalities contribute to the pathogenesis of recurrent early pregnancy losses. One is that     of the pregnancies of the women with polycystic ovary syndrome, around 30 and 50% end with     first-trimester miscarriages. Hyperinsulinemia is a prevalent feature of the syndrome, and     interventions proven effective in reducing insulin levels, such as metformin, have been shown     to reduce the rate of early miscarriages. The other is that patients with body mass index of     ≥25 kg/m2 have significantly higher odds of early miscarriage, regardless of the method of     conception.      The investigator's hypothesis was that a balanced diet combined to regular exercise, by     improving glucose homeostasis, would increase the take-home baby rate in women with     consecutive early miscarriages. Moderate exercises are usually well tolerated not only by the     mother, but also by the fetus, as indicated by tests of fetal well-being, including umbilical     artery systolic to diastolic ratio.   "
20049|NCT03023124|"     Phase II randomized study for the comparison of trabectedin versus doxorubicin plus     dacarbazine in patients with advanced solitary fibrous tumor   "
20050|NCT03023111|"     Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony     (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been     described in up to 50% of patients, and the long period of 60 to 90 days required for healing     of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives     include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited     either by toxicity or because, as with Sbv, the parenteral route hinders adherence and     regularity of treatment in the rural area. Recent studies by our group indicate that oral     miltefosine is the most effective drug for the treatment of patients with CL caused by L.     (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75%     respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue     damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L.     (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the     use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis     in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.   "
20051|NCT03023098|"     The purpose of this study is to determine whether the use of drug-eluting balloons is     effective in the treatment of (re)stenosis in bypass vein grafts.   "
20054|NCT03023059|"     From 3 large patient databases, patients diagnosed with AMD who have never taken     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD     at 79 years.      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects     the retina and downregulates VEGF, which is the cause of neovascularization.      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients     with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due     to wet (neovascular) AMD.      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients     with Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and     measure the effects on visual acuity, retinal abnormalities due to wet AMD, and document     the number of anti-VEGF injections required during the study.   "
20055|NCT03023046|"     This phase II trial studies how well etoposide, prednisone, vincristine sulfate,     cyclophosphamide, and doxorubicin (DA-EPOCH) works in treating patients with acute     lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as     etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading.   "
20056|NCT03023033|"     The goal of this proposed intervention study is to increase the proportion of HIV positive     and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed     infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of     HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing     within 8 weeks of age.   "
20057|NCT03023020|"     The study compares two lengths of medication therapy (a shortened versus a prolonged dual     antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the     successfully treatment for coronary heart disease with a drug covered stent (metallic tube).      This comparison will be done in patients who, compared to the average patient, are more     likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are     within the current medical recommendations. The aim of this study is to help improve further     standard antiplatelet duration guidelines.   "
20058|NCT03023007|"     A non-randomized, mono-centric, prospective interventional study that will assess the     efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a     patient will have either received a mastectomy or a mastectomy associated with axillary nodes     dissection, and/or a reconstruction by prosthesis.   "
20076|NCT03022773|"     The purpose of this study is to understand the role of nutrition and its effects on the eye     and other tissues. The investigators propose to study this by validating and correlating     various non-invasive measurement methods of carotenoid concentrations in the human eye and     skin tissue.      A secondary objective is to correlate blood levels of carotenoids on a sub-set of     participants.   "
20253|NCT03020459|"     To compare the morphologic and functional outcomes of internal limiting membrane     peeling-reposition versus peeling in idiopathic macular holes   "
20059|NCT03022994|"     Recently it has been reported that a consistent percentage of the general population consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac     Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term     'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes     the symptoms in NCGS patients, and the investigators also showed that these patients had a     high frequency of coexistent multiple food hypersensitivity. Nowadays only few data are     available on the histological characteristic of duodenal and rectal biopsies of NCWS     patients. The researchers have just demonstrated a significant eosinophils infiltration of     the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in the     rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse     gastrointestinal inflammatory/immunologic pattern. The aims of the present study are: 1) to     investigate the histological characteristics in duodenal and rectal biopsies between NCWS and     irritable bowel syndrome (IBS) patients, and 2) to evaluate which site (i.e. duodenal or     rectal) shows inflammatory/allergic features useful for NCWS histological diagnosis.   "
20060|NCT03022981|"     This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm     the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric     participants with chronic hepatitis C virus (HCV) infection.      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of     SOF/VEL for 12 weeks in pediatric participants with chronic HCV.   "
20061|NCT03022968|"     Recently revised Alzheimer Disease (AD) diagnostic1described nonamnestic presentations: 1/     language presentation (logopenic progressive aphasia) 2/ visuospatial presentation (posterior     cortical atrophy or PCA) and 3/ executive dysfunction. AD pathological changes may precede     the clinical diagnosis of dementia of AD type for a while2. Biomarkers have been developed:     biomarkers of brain amyloid-beta (Aß) (CerebroSpinal Fluid CSF concentration ßamyloid,     molecular imaging with amyloid targeted PET ligands), biomarkers of neural degeneration (MRI     hippocampal volume, regional metabolism as assessed by PET with [18F]-FDG) and may be used to     made early detection of the neuropathology associated with AD Even if CSF biomarkers (tau,     p-tau and β amyloïd are interesting to improve diagnosis of AD, they cannot provide     topographic information. PET tau imaging seems to be promise to evaluate quantitative and     spatial assessment of tau lesions both in AD and fronto-temporal lobar dementia.      The hypothesis of the research is that it exists a different regional pattern of tracer     retention across brain regions according to clinical symptoms : temporal for logopenic     aphasia and occipital for posterior cortical atrophy.   "
20081|NCT03022708|"     This is a multi-center prospective, single-arm, non-randomized, open label study to assess     feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right     Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.   "
20082|NCT03022695|"     This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate     the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.   "
20062|NCT03022955|"     This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids     on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional     brain imaging will be applied to identify regions of brain that are activated or inactivated     by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark     chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal     diet in randomized order. Reference standard methodology will be applied to measure gastric     emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, ~500kcal, ~50%     fat) will be consumed with radio-opaque markers on three consecutive days. On the third day     chocolate ingestion will be followed by measurements of postprandial brain activity using     FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the     number and distribution of radio-opaque markers in the colon. On the fourth day gastric     emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a     dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50% fat). During both     interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and     mood will be recorded. Additionally, validated questionnaires will assess digestive comfort     and well-bring at the end of each study day. These results will deliver comprehensive     information about the effects of cocoa on gastrointestinal transit and sensation.   "
20063|NCT03022942|"     To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic     release in chest cavity kinematics, diaphragmatic mobility and functional capacity in     patients with chronic obstructive pulmonary disease   "
20064|NCT03022929|"     Inappropriate antibiotic use is a major public health concern. Excessive exposure to     antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable     adverse drug reactions, and increased healthcare utilization and cost. As antibiotic     prescribing in emergency departments and urgent care centers remains unchecked, national     professional organizations including the Infectious Diseases Society of America (IDSA) and     the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the President of     the United States, recommend expansion of antimicrobial stewardship to these ambulatory care     settings. The goal of antimicrobial stewardship is to effectively promote judicious     antibiotic use in all healthcare settings, yet stewardship programs have not achieved their     potential in terms of either reach or effectiveness. Reach has been limited by implementation     mostly in inpatient settings; at the same time, recent critical experiments in behavioral     science suggest that the effectiveness of existing stewardship programs could be greatly     augmented through inclusion of behavioral nudges, benchmarked audit and feedback, and     peer-to-peer comparisons.   "
20065|NCT03022916|"     A recent publication using cadaver nails suggests that Jublia application has a negative     effect on nail polish texture.   "
20066|NCT03022903|"     This research study will evaluate the safety and efficacy of using blue light photodynamic     therapy (PDT) for treating toenail fungal infections.   "
20099|NCT03022474|"     Early life interventions for childhood obesity may provide substantial benefits. Most     existing studies aimed at school children have reported limited effectiveness, however few     have targeted preschool children. This study aimed to pilot procedures for a multifaceted,     culturally appropriate intervention for preschool children and to provide a preliminary     assessment of effectiveness of the intervention.   "
20254|NCT03020446|"     To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg     ulcers.   "
27456|NCT02926365|"     The purpose of this study is to test internet-delivered cognitive behavior therapy for     children and adolescents with anxiety disorders and obsessive-compulsive disorder in a     routine clinical setting in a rural part of Sweden.   "
20067|NCT03022890|"     The Specific Aims of this treatment development research are:      To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education     group (attention control) for persons with chronic pain who are taking methadone maintenance     therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment.     Participants will be enrolled in the active intervention for 3 months, and then be followed     for 6 months afterwards. Investigators' aims are:        1. To assess feasibility and acceptability of both the yoga class and the health education          control group. Investigators will assess credibility of the assigned intervention and          expectancy for improvement for both groups at baseline, program satisfaction following          program participation, participant adherence (class attendance rate and amount of home          practice corresponding to assigned study arm), and instructor fidelity to the manuals.          Investigators will conduct structured interviews following program participation to          understand specific aspects of both programs considered attractive, useful, or not          useful; we will solicit suggestions for improvements as well.        2. To assess safety, investigators will track all adverse events in a structured fashion.          Investigators do not expect to see any serious adverse events definitely or probably          related to study participation.        3. To assess feasibility of research procedures, investigators have benchmarks for          recruitment rate, retention for study assessments, and reliability of instructor          fidelity measures.   "
20068|NCT03022877|"     In the proposed project the investigators want to assess whether the approach of the     post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can     be used with a positive influence on the outcomes with respect to myocardial damage, cardiac     left ventricular remodeling, myocardial function, the occurrence of cardiac events and     quality of life.   "
20069|NCT03022864|"     Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The     functional imaging of magnetic resonance can reflect the extent and character of pain exactly     and the structural imaging of it can be a sign of the change. By analyzing fMRI results of     participants with acute pain and following them up for three months, the investigators expect     to find objective indicators for acute pain changing into chronic pain and give preventive     analgesia for people with high risk of chronic pain.   "
20070|NCT03022851|"     This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with     severe pulmonary hypertension (PH).   "
20071|NCT03022838|"     Sporadic and chronic dietary consumption of caffeine has substantial biological effects on     the nervous system. The effects on migraine are at large not known. In this study we want to     assess the effects of caffeine withdrawal on migraine.   "
20072|NCT03022825|"     This is a Phase II, open-label, single-arm, multicenter study of intravesical BCG plus     ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer     (NMIBC). All patients treated in the study will receive via a urinary catheter in the     bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (initial induction). After the first     disease assessment, eligible patients will receive either a 3-week maintenance course or a     6-week re-induction course (second treatment period) at Month 3. Eligible patients will     continue to receive treatment in the maintenance treatment period at Months 6, 9 and 12. The     study duration is 24 months.   "
20073|NCT03022812|"     Neck pain is fourth among the most common conditions worldwide associated with longer periods     of living with disability. Annually, about 30 000 people in Sweden undergo a whiplash trauma     (WAD), and half of those individuals will develop chronic problems with high costs for the     individual and society. Evidence for chronic WAD treatment is scarce, although neck-specific     training at a physiotherapy clinic (2 times a week for 3 months) has demonstrated good     results. A more efficient, flexible rehabilitation with reduced waiting times and lower costs     is needed, ideally replacing lengthy on-site treatment series by health care providers.     Internet-based care has proven to be a viable alternative to personal care meetings for a     variety of diseases and interventions, but studies are lacking on Internet-based     interventions for individuals with chronic neck problems. The purpose of this study is to     investigate if A) neck-specific training delivered through Internet-based care differs from     B) a longer series of treatments at a physiotherapy clinic regarding, e.g., work ability,     sick-leave and disability. This prospective, randomized study involves 140 participants.     Measurement is done at baseline, 3 months (end of treatment), and 15 months (12 months after     end of treatment in the study) and will include ratings of work ability, sick-leave, work     presenteeism, disability, pain, health, satisfaction with care, quality of life, and     cost-effectiveness. The study results may contribute to the development of a more effective     rehabilitation, flexible and equal care, shorter waiting times, increased availability and     lower costs for health care and society. The program can be implemented on a broader scale in     neck pain patients.   "
20074|NCT03022799|"     This first in human, single-center, randomized, placebo-controlled, double blind, sequential     group Phase 1 study in healthy subjects will be conducted to evaluate the safety,     tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) following the escalation of     single and multiple doses of KM-819.      The study will consist of 2 parts. In Part A, up to 5 cohorts of young adult male subjects,     and 1 single dose cohort of elderly male or post menopausal female subjects will receive     escalating single doses of KM-819. The food effect will be investigated in one of the single     dose cohorts of young adult male subjects, who will be crossed-over to the fed condition.     Once the dose level is selected for the crossed-over to the fed condition and elderly     subjects, the protocol will be amended to specify the dose level. In Part B, up to 4 cohorts     of healthy young adult male subjects and 1 multiple dose cohort of elderly male or post     menopausal female subjects will receive escalating multiple doses of KM-819. Part B will be     conducted after completion of all cohorts of young adult male subjects in Part A.      Dose escalation to the next level will be determined using safety, tolerability, and PK data     of the previous cohort.      Part A, Single Ascending Dose (SAD) Up to 40 healthy young adult male subjects and 8 healthy     elderly male or post menopausal female subjects will be enrolled and randomized to receive     either KM-819 or placebo.      Each of the 5 dose escalation cohorts consists of 8 healthy young adult male subjects; 6     subjects will receive 10, 30, 100, 200, or 400 mg of KM-819 and 2 subjects will receive     placebo. In each single dose cohort, dosing of subjects will be sentinel, i.e., 2 subjects     will be dosed on the first day (1 subject will receive active treatment and 1 subject will     receive placebo) and the remaining 6 subjects will be dosed at least 24 hours after the first     2 subjects.      Cohorts will be dosed sequentially with escalating doses. One of the cohorts will be     crossed-over to the fed condition to assess the effect of food as decided by Investigator and     Sponsor during the study after completion of the 2nd dose cohort (30 mg).      Eight elderly male or post-menopausal female subjects will be enrolled into an additional     cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested     in the young adult male cohorts and 2 subjects will receive placebo.      Part A consists of a Screening period of up to 28 days, and a 3 day Confinement period when     subjects are hospitalized for study activities. Subjects are required to return for     outpatient visits on Day 4, 7 and for the Follow up Visit on Day 14. The cohort that     crossed-over to the fed condition will undergo the same procedure up to the Outpatient Visit     on Day 4. Subjects will be confined for 3 days for the second time, and are required to     return for outpatient Visit 5 (Day 4), Visit 6 (Day 7), and for a Follow up Visit 7 (Day 14).      Part B, Multiple Ascending Dose (MAD) Up to 32 healthy young adult male subjects and 8     healthy elderly male or post menopausal female subjects will be enrolled and randomized to     receive either KM-819 or placebo.      Each of the 4 dose escalation cohorts consists of 8 healthy young adult male subjects; 6     subjects will receive 30, 100, 200, or 400 mg of KM-819 once a day (QD) for 7 days and 2     subjects will receive placebo. Cohorts will be dosed sequentially with escalating doses.      Eight elderly male or post-menopausal female subjects will be enrolled into an additional     cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested     in the young adult male cohorts and 2 subjects will receive placebo.   "
20279|NCT03020121|"     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human     Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media     diluted in HPV diluent to adjudicated histology results from biopsy.   "
20077|NCT03022760|"     The aim of this project is to develop a model for return to work (RTW) for patients sick     listed due to stress related mental disorders, which takes into account each patient's     specific situation; includes the workplace, and is well adapted to the Swedish primary care     setting.      In late 2016, general practitioners and rehabilitation coordinators at both public and     private primary care centers will be offered a one-day training about work and workability     for patients with stress related mental disorders. Also, the participants will be trained in     a specific method that includes the patient's employer early in the rehabilitation process      The project has a quasi-experimental and longitudinal design. The intervention will be     conducted on 15 different primary care centers, which will be matched with a comparison     group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18     months after sick-listing. The hypothesis is that patients who are sick-listed at primary     care centers that completely or partially implemented the specific method on average will     return earlier to work than patients sick-listed at primary care centers that did not     implement the method.      Alongside studying if the intervention has an effect on the patients' RTW over time, the     investigators aim to investigate the mechanisms explaining the effects and the individual and     organizational level (primary care units) circumstances necessary for these mechanisms to be     triggered. To gain deeper knowledge about mechanisms and context, the investigators will     conduct interviews with the treatment staff and collect registry data about the primary care     units.   "
20078|NCT03022747|"     The study will investigate, in children with acute lymphoblastic leukemia during maintenance     treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate     therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The     effect on hematological and liver toxicity parameters in blood will also be investigated as     well as clinical toxicity.   "
20079|NCT03022734|"     The purpose of this study is the increase of resection rate of primary cancer in rectal after     short course radiotherapy without interrupt chemotherapy schedule during the period of     chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the     progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including     metastasis.   "
20080|NCT03022721|"     The prospective observational study entitled Heidelberg Study on Diabetes and Complications     is designed to Monitor the presence and development of diabetic complications in type 1 and     type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new metabolic     mechanisms or new risk factors for the development of diabetic complications in order to     identify risk-subgroups. Non-diabetic controls will be enrolled for reference and comparison.   "
20083|NCT03022682|"     Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the     proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is     associated with increased mortality through its linkage to comorbidities including diabetes,     hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given     its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of     obesity and its consequences is one of the most important problems of our time.   "
20084|NCT03022669|"     The purpose of this study is to determine whether text messages/messaging (TM) or a mobile     application (app), compared with an educational website-control provided to all Veterans, can     improve adherence to antiplatelet therapy among patients following acute coronary syndrome or     percutaneous coronary intervention (ACS/PCI).   "
20085|NCT03022656|"     Brace treatment is the most effective non-surgical method for the treatment of Adolescent     idiopathic scoliosis (AIS). The goal of bracing is to stop the curve progression during the     high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with     pressure pads installed inside the liner to provide mechanical support to the curvature of     the spine. It is a big commitment for adolescents to wear a brace because it is physically     restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to     make the brace treatment as effective as possible to get patient buy-in to compromise their     lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to     attain their compliance.      This randomized clinical study will investigate if the effectiveness of brace treatment can     be maximized by combining ultrasound imaging assistance during brace design with the smart     brace to automatically maintain corrective brace pressures at the optimum level during the     whole treatment period.   "
20086|NCT03022643|"     Behavioral and biological rhythms are essential for health. No study evaluated behavioral     rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective     of this study is to gather preliminary data, focusing on the role of behavioral rhythms in     the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood).     Additionally, this study will provide preliminary data for the feasibility and acceptability     of the therapeutic approach aiming to strengthen behavioral rhythms for patients with chronic     pain.   "
20087|NCT03022630|"     The purpose of this study is to evaluate, through a randomized controlled trial, the impact     of integrated comprehensive palliative care services on time to first hospital readmission     and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The     intervention includes comprehensive, standardized palliative care services for adult     hepatology patients for which prognosis is poor.   "
20100|NCT03022461|"     The purpose of this clinical investigation is to report the long term survival and incidence     of adverse events in the patients who were implanted with HM3 in the CE Mark Study and     continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.      The study will be a single arm, prospective, multi-center, non-blinded and non-randomized     study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that     completed the 2-year follow-up in the HeartMate 3 CE Mark study.   "
20088|NCT03022617|"     Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red     itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the     finger and toe nails. The most characteristic nail findings associated with nail psoriasis     are nail pitting, onycholysis with a rim of erythema, and oil spots. Because nail psoriasis     causes a substantial disease burden for patients, it is critical that safe and effective     treatments are found for this specific type of psoriasis. Unfortunately, nail psoriasis is     often difficult to treat.      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that     is FDA approved for the treatment of psoriasis and psoriatic arthritis. Apremilast has shown     promising results for treating psoriatic arthritis and nail disease; however more data is     needed regarding its effect on nail psoriasis (Kavanaugh, et al). We hypothesize that     apremilast will prove to be highly effective in treating nail psoriasis. We propose to     conduct an open label clinical trial to investigate the efficacy and tolerability of     apremilast in treating nail psoriasis, where we will follow the package insert guidelines for     treating patients with apremilast.   "
20089|NCT03022604|"     This study is assessing the effects of a pre-workout dietary supplement.   "
20090|NCT03022591|"     This is a retrospective chart review. The purpose of this study will be to look at the     outcomes of twin pregnancies diagnosed with short cervix along with the intervention     (treatment) that these patients received.   "
20091|NCT03022578|"     Participant is being asked to take part in this study because they have glioblastoma or     anaplastic astrocytoma (AA) that has relapsed (come back) after treatment and the study     doctor thinks that it is in their best interest to receive chemotherapy for the disease.     Additionally, the study doctor thinks it may be in participant's best interest to also have a     surgical procedure called laser interstitial thermal therapy (LITT). LITT is a minimally     invasive (using small incisions) surgery method that uses lasers to destroy tumor cells.      For the procedure, the study doctor uses the NeuroBlate system to perform LITT in combination     with MRIs and software models to focus the lasers on affected brain cells.      The goal of this clinical research study is to learn if the NeuroBlate system in combination     with lomustine can help to control glioblastoma or anaplastic astrocytoma (AA) that has     returned after treatment. The safety of the combination will also be studied.   "
20092|NCT03022565|"     This proof-of-concept study will evaluate the ability of vorinostat to induce the     transformation of Class 2 uveal melanoma cells into a cell phenotype that resembles normal     melanocytes.   "
20093|NCT03022552|"     This prospective observational cohort study, will investigate the platelet phenotype,     platelet genetic composition, and role of platelets as effector cells in women with     myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at     NYU and Bellevue Medical Center, may have concurrent enrollment with the HARP Main Imaging     (NCT02914483) and HARP Stress Ancillary Studies (NCT02270359). Additionally, a group of age     and race matched disease controls 'CATH-NOCA' composed of women with stable angina referred     for cardiac catheterization, will be enrolled. Blood obtained during the initial     catheterization, 2 months post-MI, and following the stress study (for those participants     enrolled in the stress study) will be utilized for platelet testing.   "
20094|NCT03022539|"     Radiotherapy (combined with chemotherapy) is commonly used in the curative treatment of     pelvic tumours, such as in cervical, vulvar and anal cancer. In these patients, cure rates     are high but may be associated with significant treatment-related toxicities, especially     dermatologic, gastrointestinal, genitourinary and hematologic toxicity.      Accurate treatment planning and dose delivery is essential for radiotherapy in order to be     effective in terms of local tumour control and to reduce radiation-induced side effects.     However, accuracy is challenged by tumour and organ motion from fraction to fraction     (interfraction movements). At present, radiotherapy treatment planning is typically performed     on one planning-CT scan which is performed before the start of the treatment. However,     interfraction set up variations and organ motions can lead to differences between the     calculated dose distribution on the planning-CT and the radiation dose actually received by     the tumour and normal organs (actual given dose). Current photon radiotherapy of the pelvic     area is relatively insensitive to these changes and margins from CTV to PTV ensures an     adequate dose coverage of the tumour area. Despite newer techniques in photon therapy, like     intensity modulated radiotherapy (IMRT), critical organs still receive a substantial amount     of dose leading to clinically relevant acute and late side effects. With proton beam therapy,     the amount of radiation dose to the organs at risk can be significantly reduced.      For proton beam therapy (PBT) however, knowledge of tumour and organ motion will be more     important. The major potential advantages of PBT for tumours in the pelvic area in terms of     prevention of radiation-induced side effects are challenged by differences in bladder volume,     rectal filling and air gaps especially in the small bowel, sigmoid and rectum. Setup errors     and organ motion cause geometric displacement of the tumours and normal tissues, which     deteriorates the dose gradients from target volume to normal tissue. Furthermore, it can     result in changes in tissue densities in the beam path, which can alter the position of the     Bragg peaks, in turn leading to distorted dose distributions, usually manifesting as     significant local under and/or over dosage.      In this study, the investigators want to evaluate the impact of inter and intrafractional     tumour and organ motion on photon and proton radiotherapy treatment planning in order to     create robust intensity modulated photon- and/or proton treatment plans (IMRT, IMPT) with the     final aim to lower treatment related toxicity.      Objective: To explore the extent of inter- and intrafraction anatomical changes of the tumour     and surrounding normal tissues, throughout the full course of treatment, and to subsequently     assess the impact of these changes on the nominal planned dose. This information is required     to design robust treatment plans (photon and/or proton) that will ensure optimal local tumour     control while reducing toxicity.      Study design: Pilot-study (40 patients).      Study population: Patients with cervical, vulvar or anal cancer, who are planned for     radiotherapy (with or without chemotherapy) with curative intent.      Intervention (if applicable): Not applicable.      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of     clinical target volume), dose to organs at risk (OARs), such as the small bowel, rectum,     bladder and bone marrow.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat     planning CT scans without contrast agents in order to evaluate the impact of intra and     inter-fraction tumour and organ motion.      The additional radiation dose of these 5 extra CT's is relatively low (5 x 8 mSv, plus 1 x 22     mSv for the 4D CT scan) in relation to the therapeutic radiation dose (50.4-85 Gy). The risks     are therefore negligible and the burden is low.   "
20095|NCT03022526|"     The purpose of this pilot prospective randomized control trial is to compare the initiation     of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on     risk for postpartum depression symptoms. Investigators will randomize women to the receipt of     CSE or E during labor, after measuring baseline psychological, psychosocial, and     psychophysical factors related to pain and depression. The immediate research goals are to     understand whether the association between labor pain and PPD is modifiable through the use     of tailored anesthetic techniques.   "
20096|NCT03022513|"     Recently it has been reported that a consistent percentage of the general population consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac     Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term     'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes     the symptoms in NCGS patients, and the investigators also showed that these patients had a     high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and     extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'     tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,     and anemia). Nowadays no data are available on the characteristic of 'rheumatologic' symptoms     of NCWS patients. Therefore, the aims of the present study are: 1) to investigate the     prevalence of fibromyalgia-like joint/muscle pain in NCWS patient, 2) to search for possible     ultrasonographic alterations (i.e. synovitis) of hands and feet joints of NCWS patients, and     3) to evaluate modification of fibromyalgia-like joint/muscle pain in NCWS patients after a     gluten free diet period of almost 6 months.   "
20097|NCT03022500|"     To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary     sarcomatoid carcinoma   "
20098|NCT03022487|"     This is a prospective open label single blinded multi-centre observational study involving a     study group of patients already undergoing implantable cardioverter-defibrillator     (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard     30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end     of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG     and will be correlated with event rates to establish their effectiveness in predicting     arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years,     which is how long the study is funded for. This study is not randomised as all study patients     will be receiving the EP study performed at baseline. A minimum of 440 patients will be     recruited to document event data at standard clinical ICD follow up intervals - equating to a     maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will     be performed by a nominated researcher who will not have details of patient health status.   "
27698|NCT02923180|"     This study evaluates the safety, anti-tumor effect, and immunogenicity of Enoblituzumab given     before radical prostatectomy. All patients will receive Enoblituzumab for 6 weekly doses     beginning 50 days prior to radical prostatectomy.   "
20101|NCT03022448|"     The aim of the non-interventional study is to prospectively collect and analyze data on the     geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with     focus on patients who have been assessed by the treating physician as being unsuited to     receive standard chemotherapy with anthracyclines and / or ifosfamide.      Trabectedin will be used according to the local SmPC. Modification of the treatment schedule     should follow the standard medical practice at the discretion of the treating physician and     is not part of this Observational Plan.   "
20102|NCT03022435|"     This study will investigate markers, mechanisms and define general predictors for     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic     twins.   "
20103|NCT03022422|"     This study will investigate markers, mechanisms and define general predictors for     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic     twins.   "
20104|NCT03022409|"     This biomarker window basket study has been designed with the intent of assessing the effects     of different agents in both tumour tissue and peripheral samples to further inform optimal     combinations of DDR agents with immuno-oncology (IO) therapies and the suitable sequencing     and relative timing of these therapies.      In the first instance 2 DDR agents will be assessed as monotherapy. Based on emerging data     additional arms may be incorporated to evaluate other DDR agents and/or DDR and immunotherapy     agents in combination or in series.      The primary objective of the study is to investigate immune activation due to DDR inhibition     by monitoring the induction of TH1/IFNg response in tumours of patients treated with study     investigational agent(s)   "
20105|NCT03022396|"     This study will investigate response to influenza vaccines in monozygotic and dizygotic twins     of different ages.   "
20106|NCT03022383|"     To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus   "
20107|NCT03022370|"     This study evaluates whether the behavioural/structural interventions of Stepping Stones and     Creating Futures can reduce the incidence of intimate partner violence in urban informal     settlements amongst young people. Half the participants will receive the interventions, while     the other half will be in a control wait-list, only receiving the intervention after final     data collection.   "
20108|NCT03022357|"     Prospective observational study to compare sensitivity of 3T functional Magnetic Resonance     Imaging (3T fMRI) at diagnosing Parkinson's Disease (PD) against the benchmark DaTScan     diagnostic test and clinical diagnosis at follow up.   "
20127|NCT03022110|"     The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and     traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the     cyst recurrence rate of 12 months after treatment.   "
20128|NCT03022097|"     This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and     multinational Phase III study to determine the efficacy and safety of Aclidinium     bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium     bromide compared with Placebo when administered to patients with stable Chronic Obstructive     Pulmonary Disease (COPD).   "
20109|NCT03022344|"     However, there is only very sparse information regarding the atherosclerotic burden and     cardiovascular biomarkers in the early stages of type-2 diabetes, as the vast majority of     studies have concerned diabetes populations with more than 5 years average diabetes age or     high-risk subgroups, who at inclusion already had atherosclerotic disease manifestations.      Consequently, this study aims on evaluating the occurrence of early-stage subclinical     atherosclerosis in newly diagnosed type-2 diabetes with special emphasis on coronary plaque     characteristics by modern imaging techniques. These findings will be compared to the     functional status of various peripheral arterial segments and biomarkers in the     cross-sectional part of this study. The 5-year follow-up study intends to describe     relationships between these selected measures for general atherosclerotic involvement and the     progression of the coronary atherosclerotic burden by contemporary techniques.   "
20110|NCT03022331|"     The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a     variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA),     Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others. This     study will establish a longitudinal cohort for these diseases.   "
20111|NCT03022318|"     From 3 large patient databases, patients diagnosed with AMD who have never taken     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD     at 79 years.      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects     the retina and downregulates VEGF, which is the cause of neovascularization.      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients     with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due     to wet (neovascular) AMD.   "
20112|NCT03022305|"     The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more     effective in improving range of motion and torque production at the shoulder joint than     traditional exercises for improving hip internal rotation and adduction range of motion.   "
20113|NCT03022292|"     A study investigating the ability of OCTA imaging technology to identify and analyze     untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with     exudative macular degeneration, as well as investigating the ability of the OCTA imaging     technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in     neovascular lesions associated with macular degeneration.      This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography     by Optovue) to image and evaluate the treatment outcomes of using standard of care     Intravitreal Aflibercept Injections for their approved use in patients diagnosed with     neovascular AMD who are naive to previous Anti-VEGF therapies.   "
20114|NCT03022279|"     The objective of this study is to compare transversus abdominis plane (TAP) blocks to local     wound infiltration (LWI) in terms of postoperative pain control in pediatric patients     undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be     superior to LWI for postoperative pain control resulting in decreased use of opioid /     narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative     period. The rationale is that determining the effect of analgesia in this pediatric     population is important to optimize clinical care.   "
20143|NCT03021902|"     This study proposes a novel early intervention combining Intravenous (IV) amino acids plus     in-bed cycle ergometry exercise to improve physical outcomes in critically ill patients. The     investigators hypothesize that this innovative approach will improve short-term physical     functioning outcomes (primary outcome), as well as amino acid metabolism, body composition,     and patient-reported outcomes at 6-month follow-up.   "
20748|NCT03013985|"     The purpose of this study is to find out if treatment with Glargine U300 when compared to     Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),     who are admitted to the hospital and then transition at home, after discharge from the     hospital.   "
20115|NCT03022266|"     The proposed study is a pilot randomized clinical trial (RCT). Participants in the     intervention arm will participate in a 90-day adherence promotion program based on the theory     of behavioral economics and administered through the Wellth mobile phone application.     Subjects will be provided a CleverCap® Lite BLE C035 smart pill bottle (electronic monitoring     (EM), device) containing a 90-day supply of aspirin (90 pills) and those in the intervention     arm will be offered $150 for app-based medication check-ins, which consist of uploading daily     photos of pills at the time of administration through the Wellth app. Subjects will have $2     deducted from total rewards for each day that a medication check-in is missed. Subjects in     the control arm will receive usual care and be monitored with the same EM device types used     in the intervention arm.   "
20116|NCT03022253|"     Patent ductus arteriosus (PDA) is a common problem in preterm babies. Recently there have     been various studies for and against an association between thrombocytopenia and PDA. A     meta-analysis published in 2015 showed a marginally significant positive association between     PDA and thrombocytopenia but these were all observational studies and there are no randomized     controlled trials (RCT) on it. The investigators decided to conduct an RCT to determine     whether liberal platelet transfusion criteria achieve earlier PDA closure rates than standard     restrictive platelet transfusion criteria among thrombocytopenic preterm neonates (<35 weeks'     gestation) with hemodynamically significant PDA presenting within the first 14 days of life.     The investigators primary objective is to determine whether liberal platelet transfusion     criteria achieve earlier PDA closure rates within 120 hours compared to standard restrictive     platelet transfusion criteria among thrombocytopenic preterm neonates (<35 weeks' gestation)     with hemodynamically significant PDA presenting within the first 14 days of life.      The investigators will stratify the study population based on platelet count, i.e < 50000 and     50000-100000 per microlitre, and will randomly allocate participants to control and     intervention group. Babies in the intervention group will receive platelet transfusion to     maintain the platelet count above 100,000 per microlitre. Babies in control group will     receive platelets only when clinically indicated and as per current standard indications. The     investigators will perform an echocardiogram at baseline to document a hemodynamically     significant PDA (hsPDA) and then serially to look for the closure of PDA. Medical management     of PDA will be as per unit policy. The investigators will follow the baby till PDA closes or     120 hours post randomization.   "
20117|NCT03022240|"     The demand for magnetic resonance imaging (MRI) in pediatric patients is increasing due to     its use in medical diagnosis and surveillance. Pediatric patients often require general     anesthesia (GA) for MRI due to the need for prolonged immobility during the scanning process     to obtain high quality images. Two widely used anesthetic techniques for pediatric MRIs are     volatile-based anesthesia using sevoflurane and total intravenous anesthesia (TIVA) using     propofol. Concerns have been raised regarding the potential neurotoxic effects of anesthetics     on the developing brain. Within the animal literature, there is emerging evidence to suggest     that both sevoflurane and propofol may cause inflammation, impacting brain cell survival and     connections, thereby contributing to possible cognitive dysfunction. However, given the     challenges in extrapolating the animal data to humans, and the relatively limited human     cohort studies examining the long-term effects of anesthesia exposure, there is inadequate     information available to make informed clinical decisions regarding the choice of optimal     anesthetic agents for MRI in children. Therefore, this study will uniquely examine the     mechanisms of two widely used anesthetics and their short and long-term impact on     developmental outcomes in healthy children.   "
20118|NCT03022227|"     Cochlear implants (CIs) are medical devices now widely used in persons with severe to     profound hearing loss. After a six month to one-year period following implantation, adults     typically reach optimal fitting parameters, which lead to a stabilized hearing performance     with their CI. At this stage, they usually enter a routine clinical after-care program, which     involves regular appointmentsattheir CI center. Such visits aim at identifying any     complication, which can be medical (abnormal cutaneous healing evolution) and/or device     related, as well as any declinein performance (possibly related to the former). In France,     the HAS (French Health Authority) recommends CI users tobe seen around threetimes a year     during the second and third years after implantation, and then annually. While the schedule     of appointments remains dependent on centers' practices, there is some kind of consensus     about the minimal content of a long-term follow-up session:medical consultation, CI external     parts checking, free field aided tonal audiometry, fitting adjustments if necessary,speech     understanding assessments.      Our center (CRIC) is one of the biggest French CI implant centers approved by the HAS,     providing after-care for no less than 750 CI users, most of whomhave entered their long-term     follow-up period. For some, attending follow-up appointments may need several hours, require     taking a half-day off work, and entail travel expenses. Some patients may also have     associated disabilities making it difficultto reach the center.Moreover, although the cohort     of patients has increased over the years, the number of trained professionals and the     clinical care infrastructures have not evolved proportionally. As a consequence, there is a     need to reduce the number of routine visits, to allow more scope for complex cases andto     efficiently identify issues.      Remote consultation seems to address all the points listed above. However, it appears that     little has been doneto develop remote after-care for cochlear implant recipients. Published     studies mainly focus on the fitting aspects.      The development of telemedicine has become one of the key priorities of the French government     over the past few years, and it is now feasible thanks to the development of high speed     connections (ADSL, mobile internet, high definition transmissions). Promoting telemedicine     has several goals, the main one being to extend health care services to underserved patients     in remote locations; it also allows some medical units to be freed upand to reserve     infrastructures and professionals for patients requesting critical care. Of course,     telemedicine is also meant to save costs.      The objectif of this protocole is to evaluate the feasibility of telemedicine applied to     adult cochlear implant users' follow-up by comparing the data of the medical consultation and     speech therapy assessment, carried out in the CRIC service and videoconferencing when the     patient is home, using his computer equipment to communicate with the CRIC.   "
20119|NCT03022214|"     Since 1948, health has been defined as a state of complete physical, mental and social     well-being, and not merely the absence of disease and infirmity . However, a growing school     of thought suggests that health represents an ability to be adaptable and flexible in     response to daily stressors. It has been proposed that instead, the view of health should be     towards the ability to adapt and self-manage in the face of social, physical and emotional     challenges, which has been termed resilience.      The theory of resilience relates health to the body's capacity to manage daily stressors     (such as physical activity or oxidative fluctuations) that challenge homeostasis, with the     return to homeostasis resulting from several physiological stress responses. Although this is     an all-encompassing model, and the effects of pathogens and other stress factors are also     relevant, this study will centre on the physiological aspects on this theory, focussing on     the disruption through exercise.   "
20120|NCT03022201|"     This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in     patients with Parkinson's disease   "
20121|NCT03022188|"     Neuroendocrine tumors (NETs) and carcinomas account for 10-15 % of all pancreatic     incidentalomas. The management of pancreatic NETs depends on tumor stage and on presence or     not of hormonal syndrome. The therapeutic approach for hormonally functional tumor, or large     tumor (> 2 cm) with local, vascular or lymph nodes invasion, highly suggestive of malignancy,     or in presence of metastasis, is well admitted: surgery is indicated or should be discussed.     However, the attitude is less consensual for small (≤ 2 cm) non-functioning (NF) and     non-metastatic lesions. In English, American or French recommendations, systematic surgical     resection with lymphadenectomy is currently recommended in all medically fit patients. The     follow-up (FU) is possible for tumors <2 cm (T1) located in the pancreatic head and for which     enucleation is not feasible. Several recently published retrospective studies discuss the     non- surgical management of the small NF incidentally detected pancreatic NETs (IPNETs) and     highlight the necessity of developing guidelines for management of these patients. A strict     correlation between tumor size and malignancy of these tumors was demonstrated in the     single-center retrospective Italian study of Bettini and col., which included all patients     with NF PNETs who underwent curative (R0) resection during 18 years. In the group of 51     patients with small size of T (2 cm or less), incidentally discovered, the majority of lesion     was benign, and the authors concluded that follow-up can be proposed in patients with     incidentally discovered NF PNETs ≤ 2 cm. However in despite of small size and asymptomatic     character of the tumor, the rate of malignancy of NF IPNETs ≤ 2 cm was estimated to be 24 %     (in 18% and 6% of cases, uncertain behaviour and carcinoma were present). Given the inherent     morbidities associated with pancreatic surgery, a risk-benefit calculation may favour     surveillance rather than surgery in highly selected patients. Thus, a better understanding of     NF IPNETs and identification of their prognostic factors can be of help to select a subgroup     of patients who could benefit from a long-term surveillance rather than a systematic surgical     resection. Clearly, large prospective trials are needed to validate this approach.   "
20122|NCT03022175|"     The purpose of this study is to assess the safety and tolerability of single and multiple     intravenous doses of SPR741 when administered to healthy adult volunteers.   "
20154|NCT03021759|"     In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled     trial to evaluate an active choice intervention with and without social comparison feedback     to increase physician statin prescribing rates for eligible patients.   "
20123|NCT03022162|"     Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer     agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced     peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced     peripheral neuropathy most commonly presents as        1. Pain        2. Burning,        3. Tingling (pins and needles feeling) or electric/shock-like pain,        4. Hyperalgesia,        5. Allodynia,        6. Increased sensitivity to cold or heat These symptoms are classically seen symmetrically          in the distal extremities (glove and stocking distribution).      Most adverse effects associated with chemotherapy are ameliorated after cessation of the     therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related     symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of     neuropathic pain in breast cancer patients has high clinical and public health significance.   "
20124|NCT03022149|"     The purpose of this study is to determine whether the remote ischemic preconditioning are     effective in the treatment of mild to moderate vascular dementia.   "
20125|NCT03022136|"     Significant differences exist among various dermatome maps. In addition, there were no     anatomical landmarks to evaluate the dermatome at the back. The investigators aim to map the     sensory innervations of lower thoracic nerves and find the dorsal landmarks to evaluate     sensory innervations by epidural block. Patients undergoing urological surgery will receive     epidural block. Fifty patients with superior border of complete sensory loss to ice from T9     to T12 (anterior median line) will be included in this study. The sensory loss to ice will be     evaluated at midclavicular line, anterior axillary line, posterior axillary line, scapular     line and posterior median line. The level of vertebrae will be identified and marked by     ultrasound. The superior border of complete sensory loss to ice from anterior median line to     posterior median line will be recorded for every patient. The dermatome map of T9 to T12 will     be drawn. The landmarks of sensory innervations at posterior median line will be established     using vertebrae.   "
20126|NCT03022123|"     270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma     (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modiﬁed     CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in     combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab     (according to CHOP-R regimen) every 21 days for six courses.   "
20130|NCT03022071|"     Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated     with significant disability, mortality and economic burden. MDD is ranked fourth in terms of     disease burden as defined by the World Health Organization (2001). Cognitive Behavioral     Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for     patients with depression. However, many patients do not respond sufficiently to treatment and     relapse rates are high. To be able to offer individualized treatment, a clinically important     question is therefore whether some patients profit more from one of the two therapies. At     present little is known on which patient characteristics (moderators) may be associated with     differential outcomes of CBT and PDT and through what kind of therapeutic processes and     mechanisms (mediators) improvements occur in each therapy mode. There are actually only     theoretical assumptions sparsely supported by research findings on what moderates and     mediates the treatment effects of CBT and PDT.      Aims: The overall aim of this project is to examine putative moderators and mediators in CBT     and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for     patients with MDD.      Methods and study design: The study is a randomized clinical trial. One hundred patients will     be randomized to one of two treatment conditions. The patients will be treated over 28 weeks     with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly) during the     rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The patients will     be evaluated at baseline, during therapy, at the end of therapy, and at follow-up     investigations 1 and 3 years after treatment termination. The outcome measures comprise a     large range of clinical and process variables, including assessment tools measuring specific     preselected putative moderators and mediators.      Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of     treatment should be offered the individual patient. Moreover, it will shed light on what kind     of mechanisms in psychotherapy that is followed by symptom improvement and increased     psychosocial functioning.   "
20131|NCT03022058|"     The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording EEG     in which the signal is recorded using dry-contact electrodes embedded on a customised ear     piece. One intended medical indication of the EarEEG system is the detection of     hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no     studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes.     While a finger prick test accurately measures the blood glucose level, it does not provide     continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. Recent studies     have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe     hypoglycaemia. However, some find these devices troublesome to use and utilisation of CGM has     remained limited to date. Observational data show that only a small percentage of patients     with type 1 diabetes are using CGM on an ongoing basis. Thus, there is a medical need for a     reliable hypoglycaemia detection device which is easy and convenient to use.      This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced     changes in the EEG by use of the EarEEG system.   "
20132|NCT03022045|"     The purpose of this study are to investigate the safety and efficacy of two different dose     regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or     erythrodermic psoriasis (EP).   "
20133|NCT03022032|"     This research study is evaluating a new smartphone application named the Helping Our     Patients Excel (HOPE) app with Fitbit devices. The HOPE app was designed to learn about     improving quality of life   "
20134|NCT03022019|"     Rationale:      Autologous epidermal cell suspension grafting is an effective method of surgical treatment in     vitiligo, which is suitable for treating large areas with good cosmetic results. The     RenovaCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK)     (previous name: ReCell) is a device which, compared to other forms of autologous epidermal     cell suspension grafting, is easier in use showing similar results. Efficacy and safety of     the ReCell device was proven in segmental vitiligo and piebaldism. However, the efficacy in     non-segmental vitiligo is not yet confirmed in randomized controlled trials. The     investigators hypothesize that grafting using the ReNovaCell device in combination with     standard of care is also effective in stable non-segmental vitiligo and more effective than     standard of care alone.      Objective:      Primary: to assess the efficacy and safety of ReNovaCell grafting combined with 311 nm UVB     therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental     vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and     persistence of repigmentation after ReNovaCell transplantation.      Study design: Prospective, observer-blinded, randomised, within subject, controlled, study.      Study population: 20 patients ≥ 18 years with stable non-segmental vitiligo receiving     standard of care (311 nm UVB therapy and topical anti-inflammatory therapy) for at least 6     months at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical     Centre, University of Amsterdam.      Intervention: In patients already receiving standard of care (311 nm UVB therapy + topical     anti-inflammatory therapy) 2 comparable depigmented regions are randomised to receive     ReNovaCell grafting or no grafting. Standard of care will be given according to the standard     treatment protocol of our institute.      Main study parameters/endpoints:      Primary outcome:      Objective assessment of the degree of repigmentation three and six months after ReNovaCell     grafting with a digital image analysis system. To assess the pigmentation, the contours of     pigmentation are copied on a transparent sheet before, three and six months after treatment,     after which the sheets are scanned and digital image analysis is used to compute the affected     surface. By comparing pre- and post-treatment pictures, the relative surface showing     repigmentation expressed as percentage of the selected treated patch is computed.      Secondary outcomes:        -  Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability        -  General patient assessed outcome per treatment region on a scale from 0-3 (poor,          moderate, good or excellent).        -  Visual assessment of percentage repigmentation by blinded observer and color match to          normal skin        -  Visual assessment of side effects per treatment region (hyperpigmentation,          hypopigmentation and scarring on a scale from 0-3) by a blinded investigator.        -  A small amount of the suspension of the included patients and the redundant lesional          punchgrafts of all patients will be used for flow cytometric analyses of the cellular          composition of the grafted cell suspension, and expression analysis of melanin          synthesis-related genes. These data will be correlated to the clinical data.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: As the study involves large depigmented lesions, which are too large to treat in     regular surgical treatment (punch grafting), patients will not miss any regular treatment.     The time investment for the patient will be approximately 20 minutes for the punchgrafting     session, 75 minutes for the cell suspension grafting session and 15 minutes for the three     follow-up visits. Two of the five visits are part of the standard of care UVB follow-up     regimen and are therefore not additional due to the study. Infection in the grafted area or     the donor site may occur but is very rare; the risk of mild textural changes in the donor     site is moderate. Hyperpigmentation of the treated area does occur often, although this     improves over time in most cases. In case of improvement of the depigmentation, patients may     receive another treatment for the (contralateral) untreated side.   "
20155|NCT03021746|"     To understand the effectiveness of three approaches to address diabetes self-management     support compared to enhanced usual care in church-based settings.   "
20156|NCT03021733|"     This project will involve planning and implementing a two-arm prospective pragmatic cohort     clinical trial in patients with known rotator cuff tears.   "
20135|NCT03022006|"     The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million     and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is     high in hemodialysis patients, and it has been revealed that the prognosis is poorer in     HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive     therapeutic intervention is required.Investigator previously reported the efficacy and safety     of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir combination     therapy for Japanese dialysis patients with genotype 1 HCV infection. However, the duration     of the treatment is 24 week, which is quite longer than current standard 12 week therapy .      elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of     IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies .     Of note is that these drugs are metabolized mainly in the liver and thus they can be used in     patients with chronic renal failure. Recently, David Roth et al reported that the efficacy     and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis C virus     genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they revealed that     elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the modified full     analysis set.      However, no adequate clinical investigation has been performed in Japan, thus far concerning     the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese     hemodialysis patients.   "
20136|NCT03021993|"     The purpose of this study is to look at the effectiveness of nivolumab in patients with oral     cavity cancer (OCC) who are about to undergo surgery.   "
20137|NCT03021980|"     This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention     for preschool children. It will consist of both an preschool component and a family component     and is aimed at increasing healthy nutrition and physical activity. Half of the participating     preschools will implement SuperFIT, while the other half of the preschools will continue as     usual.   "
20138|NCT03021967|"     Hospitals, doctors and caregivers, who take care of increasingly heavy patients, are faced     with ever more complex situations, particularly in the case of severe, progressive, and     incurable pathologies.      Thanks to their willingness and expertise, these care providers try to guarantee the     continuity and quality of care for both patients and patients in a palliative situation.     Nevertheless, these same actors testify to the complexity they encounter in the care of     patients in advanced or terminal stages, especially since the concept of palliative care,     which was often erroneously reduced during the Any end of life and therefore death, remains a     source of questions, contradictions, even resistances.      In this context, how do physicians and caregivers appropriate palliative care? How do they     react to the complexity and intensity of certain situations? Do they have specific     expectations of help or support in the face of certain difficulties? Are there actions to be     carried out and developed to make the aid given to these actors of the palliative approach     more efficient?      These are the topics that the HUS palliative care service proposes to explore through a study     of physicians and caregivers working in HUS services for adult patients with LISP.   "
20139|NCT03021954|"     This study aims to see if platelet rich plasma (PRP) have beneficial effect on the repair of     pelvic floor muscle damage in primipara. Therefore, this double blinded randomized clinical     trial compares the pelvic floor muscle repair in primipara following labor between the     interventional group who received intramuscular PRP injection in levator ani muscle and the     control group, as assessed by ultrasonography, perineometry, and biomarker assessments.   "
20140|NCT03021941|"     In August of 2014, the FDA approved ELELYSO for long-term enzyme replacement therapy (ERT)     for pediatric subjects with a confirmed diagnosis of Type 1 Gaucher disease. The recommended     dosage for treatment-naïve adult and pediatric subjects 4 years of age and older is 60 units     per kg of body weight administered every other week as a 60 to 120 minute intravenous     infusion. As a postmarketing commitment, the Sponsor agreed to evaluate the pharmacokinetics     (PK), pharmacodynamics (PD), and safety of Elelyso (taliglucerase alfa) in pediatric subjects     with Type 1 Gaucher Disease. in at least 5 subjects with body weight less than 15 kg; at     least 5 subjects with body weight 15 to less than 20 kg; and at least 5 subjects with body     weight of 20-25 kg with Type 1 Gaucher disease dosed at 60 units/kg every other week.      When applicable, PD measurements for children enrolled in the PK study may be obtained     through the taliglucerase alfa registry (PMR 1895-5) and will include organ volumes (spleen     and liver), hematological values (hemoglobin and platelets) as well as growth (height and     weight) data. Safety data, including any serious hypersensitivity reactions, such as     anaphylaxis, as well as changes in antibody status (ie, detection and titers of binding and     neutralizing antibodies, and detection of IgE antibodies), will also be collected through the     taliglucerase alfa registry.   "
20141|NCT03021928|"     Title:      Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation     (START): a pragmatic, adaptive randomized clinical trial.      Primary Objective:      • To determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral     Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial fibrillation.      Secondary Objectives:        -  To compare the rates of primary adverse outcomes in a per protocol analysis        -  To compare 30 day clinical outcomes by the modified Rankin scale among the          time-to-treatment groups        -  To compare 90 day clinical outcomes by the modified Rankin scale among the          time-to-treatment groups        -  To explore the optimal timing in subgroups of age, sex, outcome category, and NOAC          choice   "
20142|NCT03021915|"     This is a single center, prospective, controlled pilot safety research study. The primary     objective of this research study is to assess the safety with the use of the OvaPrime     procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor     ovarian response (POR).      A maximum of seventy (70) subjects will be enrolled to achieve the target sample size of 60     Modified Intent-to-Treat (mITT) subjects as the primary analysis population. Each subject     shall have one ovary exposed to the EggPC cells while the contralateral ovary is exposed to     the EggPC vehicle as a means to have each subject serve as their own control. Results between     the treatment and control ovary will be examined for relevant endpoints such as antral     follicle counts.      The duration of the research study is estimated at approximately 6 years total, for the     period spanning enrollment (estimated at approximately six months), eight months to the last     hyperstimulation and through completion of 5-year follow-up (main study protocol with one     year primary endpoint and LTFU sub-study which extends to 5 additional years).   "
20144|NCT03021889|"     Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and bodily     changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia latter     being associated with a higher chance of cardiovascular events and death.      Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living     with HIV / AIDS in antiretroviral therapy.      Method: This is a randomized clinical trial with young people 13-19 years in outpatient     treatment in a general hospital to present dyslipidemia. The intervention group received     nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control     group received standard care consisting of medical care. Demographic, clinical, nutritional     variables, food surveys and lipid profiles were collected at baseline and at the end of the     study for both groups.   "
20145|NCT03021876|"     L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine     in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in     corresponding tissues of eight normally nourished non-hepatic patients who died after an     acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3     (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to     improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal     injury. In the current study, it is the first clinical interventional research whether     L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized     patients.   "
20146|NCT03021863|"     Questionnaires are frequently used in online research, however recruiting, and completion     rates of online participants from a variety of cultures and demographic backgrounds can be     challenging. The challenge is greater in an online cohort because there is no way to observe     the participant beyond what is contributed online. Poor recruiting and completion can result     in underpowered research that may not be representative of the sample population. This can     trigger an increase in costs as the recruitment period may have to be extended until sample     size is reached. When recruiting and completion rates are inadequate studies may have to be     terminated and the answer to the research question can remain unknown.      To mitigate these challenges, reminder emails are sent to questionnaire respondents. There is     uncertainty about how the tone of the email reminder affects the proportion of recruitment     rates.      A nested randomized trial will be used to test the intervention of tone delivery in survey     email reminders to establish an evidence base. This study (ResponseQT) proposes to link with     the anticipated 20,000 person international cohort study, (How Frequently and in What Format     are Research Trial Results Disseminated to Participants: A Survey of Trialists (ResponseQT)     to explore the evidence of effect for the research question, Does the tone of a survey email     reminder affect the proportion of survey participants recruited. The population will consist     of researchers who have published a clinical trial indexed in Pub Med in 2014-15.The     intervention is the tone of questionnaire email reminders and the outcomes will be the     proportion of participants recruited after invitation (partial plus complete responses)     following reminder 1 and 2.   "
20148|NCT03021837|"     This study will look at blood sugar levels in pregnant women who have been given a     glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help     determine the likelihood, predictive value, adverse effects, response of patients diagnosed     with gestational diabetes and time course of blood sugar elevation following steroids.   "
20149|NCT03021824|"     An assessment of early management of moderate-severe ARDS in the United States, including     ventilator management and use of rescue therapy.   "
20150|NCT03021811|"     Multi-center, prospective, interventional, uncontrolled open-label study evaluating the     real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg     ulcers, diabetic foot ulcers, pressure ulcers).   "
20151|NCT03021798|"     The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no     therapeutic intervention that will be conducted in three European countries, (Belgium, France     and Italy), and in the US.      300 community dwelling older adults (men or women≥65 years) reporting loss of physical     function and at risk of mobility disability, will undergo mobility functional evaluation and     Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at     six-month interval.      Participants aged ≥ 65 years complaining of poor physical function will be selected to     perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be     selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI <     0.789 in men and 0.512 in women will be included. The investigational phase will comprise two     main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test     and the 400-metre walking test will be administered at the main visits. Patient Reported     Outcomes (PROs) will be completed by the patients at the same visits.   "
20152|NCT03021785|"     This is a multicenter, open-label study to evaluate the safety, pharmacokinetics,     immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients     with AMD. It consists of core study (12 weeks) and extension study (40 weeks).   "
20153|NCT03021772|"     Intravenous regional anesthesia (IVRA) is described firstly in 1908 by August Bier. It is     simple, safe, reliable, less cost, efficient method in forearm surgery. The advantage of this     method has fast return of motor and sensory function which enables patients for earlier     discharge. However, this method has disadvantages such as tourniquet pain, insufficient     muscle relaxation and postoperative analgesia.      Lidocaine inhibits action potential propagation within neuronal tissue by binding to     receptors in Na+ channels located on the nerve cell membrane. Lidocaine IVRA is safe and     effective and is associated with a rapid onset (4.5 minutes) of anesthesia after injection     and termination of analgesia (5.8 ± 0.5 minutes) once the tourniquet is deflated.      Neostigmine is a typical cholinesterase inhibitor. It increases the level of acetylcholine     (Ach) and indirectly stimulates both nicotinic and muscarinic receptors. In anesthesia,     neostigmine is a drug that has been used for reversal of residual neuromuscular block.     Administration of neostigmine by intrathecal and epidural routes has been found to cause     analgesia by inhibition of the breakdown of Ach in the spinal cord.      Dexamethasone is commonly used in anesthesia to prevent postoperative nausea and vomiting     (PONV). Two recent meta-analyses have documented that dexamethasone also reduced     postoperative pain and opioid requirement. Intravenous dexamethasone has also been shown to     improve postoperative pain control in patients receiving spinal or epidural morphine.      Hong et al reported that intravenous dexamethasone in combination with a caudal block with     ropivacaine prolonged the duration of postoperative analgesia without adverse effects in     children undergoing orchidopexy. So the investigators expect that addition of dexamethasone     or neostigmine will affect duration and postoperative analgesia in bier block.   "
20158|NCT03021694|"     The importance of protein in nutrition is momentous to ones health. Dietary proteins are     essentially nutritional because they contain amino acids, which the body uses to build its     own proteins, as well as other molecules that are essential for life. Protein when consumed,     travels through your digestive system and is absorbed. They then enter the blood for     transport to bodily tissues, and therefore, can be detected by blood sampling. There are     differing amounts of each amino acid found in different types of protein supplements. Certain     amino acids (the essential amino acids) are helping in stimulating muscle growth and helping     to maintain muscle mass and function. It is important to understand how quickly these amino     acids can be detected in your blood as well as how they affect blood glucose (blood sugar)     and insulin activity. Understanding the effects of protein type on changes in levels of blood     amino acids, glucose and insulin will provide helpful insight for the suggestion of     supplement use.   "
20159|NCT03021681|"     Chronic obstructive pulmonary disease(COPD)is characterized by recurrent cough, expectoration     and asthma, and eventually develop chronic pulmonary heart disease ,chronic respiratory     failure and even death. The current clinical treatments for these patients are symptomatic     treatment cannot solve the problem of the damaged lung structure fundamentally. Recent     studies show that bronchial basement the layer of cells is a kind of cells in the bronchial     epithelial basal layer position, the specific expression of Krt5 antigen with the     regeneration and repair of lung function , these cells have the activity similar to adult     tissue stem cells. Its division and migration are more active and can continue to produce new     cells to complement the death of other types of epithelial cells with functional plasticity     which can be used to direct repair the bronchial and alveolar structures. It has been proved     that bronchial basal cell transplantation can repair the damaged lungs of experimental     animals . The bronchial basal cells from autologous tissue, so there is no immune rejection     problem. Also because the bronchial basal cells derived from adult tissues which is a part of     the body, so there is no risk of a tumor (in animal experiments, In animal experiments,     bronchial basal cells transtracheal input 100 times in human dose still no tumor formation).     In the early stage, patients with COPD (2 cases), bronchiectasis (2 cases) and interstitial     lung disease (1 case) received the treatment, and the overall effect was good. Diseases were     alleviated and recovered to some different extend.The study was to brush bronchial basal     cells through fiberbronchoscopy in COPD patients and cultured in vitro, and then through the     bronchoscope transfusion to the lesion site. To preliminary evaluate the efficacy and safety     of autologous bronchial basal cells in the treatment of chronic obstructive pulmonary     disease.   "
20160|NCT03021668|"     Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a     high perioperative complication rate. Surgical site infection is one of the most common     complications after pancreaticoduodenectomy. In a retrospective review of all patients who     underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679     patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis,     perioperative blood transfusion, operative time greater than 7 hours, preoperative     chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure     device, and vascular resection were associated with surgical site infection (all, p<0.05). On     multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were     independent predictors of surgical site infection (all, p<0.001). Studies in colorectal     patients have found an estimated cost of up to $1400 per patient secondary to prolonged     hospitalization, wound care, and wound complications in patients with procedures complicated     by a surgical site infection. Furthermore, in another study of 1144 patients undergoing     pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative     complications delayed time to adjuvant therapy, decreased median survival.      The hypothesis of the investigator(s) is that placement of Prevena Peel & Place Dressing     using the standard Acelity vacuum dressing after suture on patients undergoing     pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in     surgical site infection rate. The investigator(s) plan to perform a randomized control trial     where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant     chemotherapy will undergo closure with Prevena Peel & Place Dressing using the standard     Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then     follow the participant(s) for 30 days postoperatively to determine surgical site infection     and other perioperative complication rate.   "
20161|NCT03021655|"     This study is a 3-arm randomized controlled trial including: (1) Adventure-based training     intervention group, (2) WhatsApp intervention group and (3) Control group.   "
20162|NCT03021642|"     This is a Phase I, open label, randomized, crossover trial to investigate the relative     bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized     to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference,     test. The reference treatment refers to the current Phase II film-coated tablet (5 * 100     milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III     film-coated tablet (1 * 500 mg film-coated tepotinib tablet).   "
20163|NCT03021629|"     Vitamin D deficiency is known to be significantly associated with high myopia. This study     investigated the vitamin D status in patients with high myopia and primary open-angle     glaucoma, in order to understand the relationship between high myopia and the development of     primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia     patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a,     25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D     receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment     length polymorphism technique.   "
20164|NCT03021616|"     This study will determine the cardiovascular effects of energy drink consumption in healthy     individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM®     analysis.   "
20165|NCT03021603|"     Aims. This paper describes the study protocol of a manualized brief positive intervention     (BHI). In addition, it reports the on the modification of a hope intervention based on the     theoretical proposition - hope theory, and its feasibility when applying to palliative cancer     and non-cancer patients.      Background. Hope was found to account for therapeutic changes in clients with depressive     symptoms or chronic pain. Nevertheless, little is known about the integration of such active     ingredients to brief and low intensity psycho-therapeutic interventions to patients receiving     palliative care were not adequately tested.      Design. The study included two stages: (1) manual development, and (2) a single blinded     randomized controlled trial.      Methods. Participants will be randomly assigned in equal number into either the brief hope     intervention or the controlled arm on completion of the baseline assessment. Participants of     the intervention group will be receiving the four-week intervention, while those allocated to     the control arm will be receiving the routine care and social chats. The intervention is a     manualized program that consists of four sessions at weekly intervals (two face to face     sessions and two telephone follow up in between). The core content is modified from an eight     sessions hope therapy. Expert panel feedback and trial on targeted populations were     completed. Four participants received the program to determine its acceptability prior to     feasibility testing. The process and practical considerations were evaluated to allow     refinement of the program and to ensure the quality of intervention.      Outcome measures comprise of changes in state hope score and the depression scores measured     respectively by State Hope Scale and Centre for Epidemiological Study Depression Scale. The     secondary outcomes are the common signs and symptoms in cancer patients measured by The     Condensed Memorial Symptom Assessment Scale. Data collection will be done prior to the     intervention (baseline), immediately and one month after the intervention. Additional use of     qualitative interview to explore their experiences in the intervention, including     satisfaction with the intervention and the treatment fidelity will be conducted.   "
20166|NCT03021590|"     Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on     the Eradication of Helicobacter Pylori in Syrian population   "
20167|NCT03021577|"     The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation     atherectomy device, reduces the incidence of microcirculatory compromise as compared to older     generation rotational atherectomy (RA) due to differences in the mechanism of     athero-ablation.   "
20168|NCT03021564|"     Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive     Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and     prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ     failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias     or intra-hospital arrests are the subject of numerous publications, few studies specifically     focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to     produce a prospective epidemiological description of unexpected cardiac arrest in in French     ICUs.   "
20169|NCT03021551|"     This is a prospective, observational, clinical study designed to evaluate the clinical     utility of the Oxygen Reserve Index (ORI) as an early warning for arterial hemoglobin     desaturation during the induction of general anesthesia and tracheal intubation in obese     patients undergoing elective surgical procedures.   "
20170|NCT03021538|"     This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during     lung transplant surgeries.   "
20171|NCT03021525|"     To evaluate the impact of perioperative, algorithm driven, hemodynamic therapy based on     individualized fluid and cardiac output optimization on postoperative moderate and severe     complications in patients undergoing major abdominal surgery including visceral, urological,     and gynecological operations.      In the proposed study, hemodynamic therapy is tailored individually to each patient, based on     individual preload optimization by the functional parameter pulse pressure variation (PPV)     and based on an individually titrated goal of cardiac index. The proposed study therefore     further develops the concept of hemodynamic goal-directed therapy to individually set goals     and is designed to assess its impact on morbidity and mortality.   "
20172|NCT03021512|"     Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia     correction with monofocal intraocular lenses implantation are supposed to have sufficient     uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant     vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c)     near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a     series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses     implantation, group 2: subjects with bilateral trifocal lenses implantation)   "
20174|NCT03021486|"     The goal of this clinical research study is to learn if chlorpromazine, high-dose     haloperidol, or a combination of the 2 drugs can help to control the symptoms of delirium     (loss of contact with reality) in patients with advanced cancer who did not respond to     low-dose haloperidol. High-dose haloperidol doses are usually about 2-4 times the size of     low-dose haloperidol.      In addition, researchers want to learn if treating patients with these drugs can help to     lessen any distress that their caregivers may be having.      The safety of these drugs will also be studied.   "
20175|NCT03021473|"     This is a prospective, non-blinded, non-randomized, non-interventional study of the Oxygen     Reserve Index (ORI) in a clinical setting. It is designed to evaluate the potential clinical     utility of the ORI as an early warning of impending arterial oxygen desaturation and collect     additional data characterizing the correlations with arterial blood oxygen content.   "
22487|NCT02991287|"     To asses the precision of a score to predict chronic post surgical pain in patients     undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and     thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.   "
20176|NCT03021460|"     This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients     with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.   "
20177|NCT03021447|"     Postoperative pain is a significant postoperative problem and it could be persistent if     proper management is not provided. However, each patient shows different intensity of pain     and different sensitivity to analgesics even if they underwent same procedures. Therefore, it     would be useful to find the way to predict the postoperative pain sensitivity.      Propofol, a popular anesthetic agent, induces pain during injection, which can not completely     prevented by opioid or lidocaine in some patients. This is considered to be related to     patient's pain sensitivity and it might be associated with postoperative pain sensitivity.      Therefore, the relation of propofol injection pain and postoperative pain intensity will be     explored.   "
20178|NCT03021434|"     The present study is a cluster randomized control trial of low-cost microbiological water     test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India.   "
20179|NCT03021421|"     Purpose: This prospective, randomised, controlled, single-blind, multicentre study was     designed to investigate the effects of peripheral nerve block methods (applied using     unilateral spinal anaesthesia [USA] on elderly patients scheduled to undergo total knee     arthroplasty) on perioperative haemodynamic parameters and the postoperative analgesia     period.      Materials and Methods: Sixty patients in the American Society of Anesthesiologists (ASA)     Physical Status II-III group were randomly divided into two groups. Spinal anaesthesia was     performed in the USA group, in the lateral position through the intervertebral space, with 2     ml of hyperbaric bupivacaine (L4-L5 or L3-L4); 0.5% bupivacaine hydrochloride and 2%     lidocaine were combined for the psoas compartment-sciatic (PCS) group, and the mixture was     used for psoas compartment block (PCB) and sciatic nerve block. The haemodynamic parameters     were recorded every 5 minutes until the end of the preoperative and perioperative operation     periods and postoperative first analgesic application time.   "
20180|NCT03021408|"     Evaluation of the effectiveness of three different approaches for the rehabilitation of gait     in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).   "
20181|NCT03021395|"     In this open-label, prospective clinical trial, the investigators enrolled acute myeloid     leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease     (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The     MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.   "
20182|NCT03021382|"     The objective of this study is to evaluate the precision of semi-automated lumen boundary     identification from coronary computed tomography angiography (cCTA) by current version of     HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical     coherence tomography (OCT) as reference standard.   "
20183|NCT03021369|"     The digital pleural drainage system Topaz+ by Medela is compared to the analogue system     Atrium OCEAN by Maquet in patients undergoing cardiac surgery.      The study is prospectively randomized with an all-comer setup. The patients are randomly     selected for one of the systems. The surgery is performed in the standard fashion and chest     tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32     French drain is placed in every patient and pericardial and/or pleural drains are optional.      The postoperative course does not vary from the clinical standard and the chest tubes are     removed according to institutional standard. The clinical data about fluid amount, time of     removal, air leaks, tamponade are routinely collected in a digital patient documentation     system.   "
20184|NCT03021356|"     The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical     and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress     echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on     postoperative outcome will be compared using spiroergometry, quality of life questionnaire     and heart failure biomarkers.   "
20185|NCT03021343|"     This study evaluates the role of colchicine in the prevention of atrial fibrillation in     patients undergoing open heart surgery. Half of participants will receive colchicine and the     other half will not   "
20186|NCT03021330|"     In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will     be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen     with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with     standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of     cytarabine is evaluated and adverse events associated with treatment are recorded.The primary     end point is overall survival.   "
20187|NCT03021317|"     ACTHAR is a FDA approved drug for MS relapses. The purpose of the study is to examine the     efficacy of this agent in improving relapses as measured by advanced MRI and laboratory     techniques:        1. Advanced serial MRI studies on patients during and after an acute MS relapse. MRI will          be performed at baseline, 1 month after the 1st dose of ACTHAR, and months 3, 6, and 12.          ACTHAR will be administered for 10 days. Patients will start ACTHAR within 48 hours of          relapse assessment.        2. Serial immune assays on patients during and after an acute MS relapse. Serum and blood          samples with be collected at baseline, last day of ACTHAR (day 10 of therapy), 1 month          post 1st dose, and months 3 and 6.   "
20188|NCT03021304|"     This study is aimed to assess the correct real-world use of a safety syringe for the repeat     self-administration of mepolizumab SC. This Phase III study will be an open-label,     single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety     syringe (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3 doses) in     subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a     single injection that is self-administered in the thigh, abdomen or administered in the upper     arm (caregiver only). Each subject will participate in the study for up to 18 weeks including     pre-screening visit, a screening visit and a 12-week treatment period which concludes with     end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately     55 Subjects will be enrolled in the study.   "
20189|NCT03021291|"     This study is designed to assess the effect of Gelesis100 on body weight after an additional     exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least     3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.   "
20190|NCT03021278|"     The purpose of this study is to determine whether experimentally induced acute low back pain     might lead to alteration in lumbar tactile acuity measured in region affected by pain     compared to pain-free side and pain-free controls.   "
20191|NCT03021265|"     Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio®     Combination Tablets treatment in patients with hypertension   "
20192|NCT03021252|"     Clinical randomized clinical trial to assess the effectiveness of incorporating inspiratory     and expiratory muscle training (IEMT) in the rehabilitation of stroke patients with dysphagia     in terms of functional outcomes, comorbidities, survival and quality of life.      This project also incorporates a longitudinal study to assess the clinical impact of     dysphagia on body composition and nutritional status in stroke patients.   "
20193|NCT03021239|"     The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp     Tests to determine which method of testing provides better information for adjusting pump     speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better     adjustments may provide better quality of life, exercise tolerance and reduced unwanted     cardiac events over a 6-month period.   "
20194|NCT03021226|"     The Brothers United Fatherhood Program (BUFP) will be conducting an evaluation that builds on     literature and existing research from the healthy marriage/responsible fatherhood initiatives     developed by ACF over the last 10 years, in particular the Supporting Healthy Marriage     Program initiative that established a randomized clinical trial. The Brothers United     Fatherhood Program will provide important data to expand the area of fatherhood development     with the target population. This program is funded through an initiative of the     Administration for Children and Families, Office of Family Assistance (OFA).      The study is intended to measure if the identified interventions improve the well-being and     relationship between targeted participants and their families. The study intends to focus on     the following outcomes:        -  Demonstrate increased intake & knowledge of systems that help fathers        -  Improvement in knowledge of employment & learn new opportunities for economic mobility        -  Improvement communication & empathy skills towards partner        -  Increase in understanding of healthy marriage & its value to fathers        -  Demonstrate an understanding of financial planning        -  Demonstrate improved conflict resolution, behavior patterns, including those leading to          domestic violence        -  Increase in reports of improved adult & child relationships        -  Demonstrate an increase job readiness skills such as employment preparedness & career          direction   "
20195|NCT03021213|"     Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD)     therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower     extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New     York Heart Association [NYHA] classes II to IV) and cardiomyopathy are unclear.   "
20196|NCT03021200|"     The use of fluorescence for real-time evaluation of organ and tissue vascularization and     lymph node anatomy is a recent technology with potential for the surgical treatment of     cancer. The real-time analysis of tissue vascularization allows immediate identification to     the surgeon of areas with greater or lesser blood circulation, favoring surgical decision     making and prevention of complications related to tissue ischemia (necrosis, dehiscences and     infections). It is a technology with potential application in the areas of Digestive Surgery,     Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition, fluorescence can     be used as a method to identify lymph node structures of interest in the oncological     treatment of patients with urologic, gynecological and digestive tumors.      Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through     intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp.,     Branchburg, N.J.) had its initial application in repairing surgery after breast cancer     treatment. The method proved to be useful in the prevention of ischemic and infectious     complications in cancer surgery. Pestana, in a prospective clinical series of 29     microsurgical flaps used in several reconstructions, observed a single case of partial loss     of the flap, the present technology having a relevant role in intraoperative decision making.     In the same year, Newman et al. The first application of the system in breast reconstruction     surgery. In an initial series of 10 consecutive cases of reconstruction with microsurgical     flaps, in 4 cases the system allowed the intraoperative identification of areas of low     perfusion, thus changing the surgical procedure. According to the authors, there was a 95%     correlation between indocyanine laser assisted and subsequent development of mastectomy skin     necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray et al. Evaluated     the intraoperative perfusion, however, of the areola-papillary complex in patients submitted     to subcutaneous mastectomies with satisfactory results in terms of predictability of     cutaneous circulation. Other authors in larger clinical series and evaluating other     procedures have observed valid results in terms of prevention of complications.      Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a     serious and common complication. These fistulas can be caused by insufficient perfusion of     the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can be     used to visualize the blood perfusion following intravenous injection of the indocyanine     green contrast. Several groups reported the ability to assess blood perfusion of the     anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and     colleagues described a reduction in the risk of revision due to fistula in 60% of patients     whose anastomosis was examined using laser fluorescence angiography compared to historically     paired patients without this method. The same principle can be used to evaluate the tubulized     stomach to be transposed to the cervical region after subtotal esophagectomy.      Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer     as well as investigative character in colorectal cancer, skin cancer, cervical cancer, vulvar     cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric cancer     and esophageal cancer.      These early studies demonstrated the feasibility of this methodology during surgery.     Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can     replace blue dyes because they exceed them due to increased tissue penetration depth and     absence of staining in the patient and cleaning of the operative field.      To date, there are no clinical studies involving intraoperative perfusion mapping and     identification of lymph node structures with the SPY Elite System © system or other platforms     (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an objective way     the influence of this technology as predictive in the better or worse evolution of the     oncologic surgery as well as in the prevention of the local ischemic complications by means     of intraopeal change of conduct   "
20197|NCT03021187|"     This trial is conducted globally. The aim of the trial is to investigate the efficacy and     safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated     with insulin. All subjects should continue their pre-trial insulin therapy (basal,     basal-bolus or premixed regimen including combinations of soluble insulins) throughout the     trial. Subjects treated with metformin in addition to insulin treatment must continue their     metformin treatment throughout the entire trial.   "
20198|NCT03021174|"     This is a feasibility pilot study to initiate a research program to assess the effects of     exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the     hands and feet).   "
20199|NCT03021161|"     This project will be test the effect of probiotics on occupational allergic sensitization,     respiratory symptoms and bronchial hyperresponsiveness in workers or students that develop     respiratory symptoms exposed to laboratory animals, i.e., small rodents.   "
20200|NCT03021148|"     It has been reported that a consistent percentage of the general population consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have celiac disease or wheat allergy. This clinical condition has been named     Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the     term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat     causes the symptoms in NCGS patients, and the investigators also showed that these patients     had a high frequency of coexistent multiple food hypersensitivity. To our knowledge, there     are very few studies which assessed the prevalence of self-reported gluten-related symptoms     in the community and analyze diagnostic outcomes in those referred to secondary     gastrointestinal care. In one of these, performed in UK, the authors showed that     gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming a     gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of celiac     disease. Of those patients presenting to the gastroenterology department, the majority do not     have CD but NCWS. No data are available for boys and girls. Therefore, the aims of this study     were 1) to determine the prevalence of self-perceived gluten-sensitivity in a population of     high-school students, and 2) to evaluate the demographic and clinical differences between     students self-reporting gluten sensitivity and students not reporting food hypersensitivity.   "
20201|NCT03021135|"     Randomized, comparative and prospective study between Conventional Endoscopic Mucosal     Resection for the removal of flat or sessile colorectal lesions without previous attempt to     resection.   "
20202|NCT03021122|"     The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or     divisions to prepare continuous infusions of vasoactive drugs during a simulation-based     pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to     prepare and deliver vasoactive drugs following their current conventional methods or by the     aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them     step-by-step from order to delivery of these drugs.        1. Primary outcome will be to measure in each allocation group the number of medication          dosage errors committed during each drug preparation sequence until injection.        2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug          delivery (TDD).   "
20204|NCT03021096|"     This study aims to identify the timeline of pain following total shoulder replacement with     the goal of developing data for a subsequent randomized trial. The investigators believe that     with using HSS's current protocol, many patients have postoperative pain that is no worse     than their preoperative pain. Previous HSS anesthesia protocols for total shoulder     arthroplasty patients have not formally followed patients past their hospital discharge, and     the investigators believe that some patients do experience moderate to severe subacute     postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain     scores at 14 days after surgery. Future studies will look at measures of preventing bruising     and subsequent pain after shoulder replacement.   "
20205|NCT03021083|"     The treatment of postoperative pain continues to be a challenge after posterior spinal     fusions. There is considerable evidence demonstrating that a multi-modality approach     including patient controlled analgesia (PCA) with opioids for postoperative pain management     compared to conventional opioid analgesia provides a greater analgesic effect even when the     amount of opioids consumed is similar between both groups. However, the PCA modality is often     discontinued prior to all the patients' pain needs being met. The IONSYS system uses the     concept of PCA-delivered narcotics and may be used for postoperative pain management.   "
20206|NCT03021070|"     Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven strategies that     can tackle the high burden of maternal and child mortality and morbidity currently witnessed     in sub-Saharan Africa. However very few pregnant women utilize these services. This study     aims to assess the impact, cost-effectiveness, and scalability of conditional cash transfers     (CCTs) to promote increased and uninterrupted contact between pregnant women and the formal     healthcare system in Siaya County, Kenya.      The study is a cluster randomized controlled trial with the intervention being a conditional     cash transfer to women each time they honour their health appointments for ANC, facility     birth and PNC visits until their new-borns reach 1 year of age. Study participants are     pregnant women identified during their first ANC visit (n = 7200), and their subsequent     new-borns. Mothers and their children are followed up throughout their health visits and at 3     additional time points. Trial clusters are 48 public primary health facilities, (24 in the     intervention arm and 24 in the control arm).      The primary outcomes are: a) proportion of all eligible ANC visits made during pregnancy; b)     delivery at health facility; c) proportion of all eligible PNC visits honoured; d) proportion     of referrals honoured during pregnancy and postnatal period; e) proportion of child     immunizations received. Secondary outcomes include; health screening and infection control,     live birth, maternal and child survival 48 hours after delivery, exclusive breastfeeding,     birth spacing and self-rated wellness of mother and new-born at respective time points.      Primary outcomes will be measured through abstraction of health records at the health     facilities attended by the women during the trial period and supplemented by data collection     using an electronic based system that comprises of a card and reader system installed at     recruited study facilities. Secondary data will be abstracted from the women's medical     records at the health facilities and supplemented by telephone surveys administered at three     time-points over the course of the study. Additional quantitative and qualitative data will     be collected through questionnaires and phone interviews for process and economic     evaluations.      This trial will contribute to evidence on effectiveness and cost-effectiveness of conditional     cash transfers in facilitating health visits and promoting maternal and child health in Kenya     and other similar contexts.   "
20280|NCT03020108|"     The study population will comprise of 90 women age varying between 15-55 years, those are     candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other     benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound     examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis     of serum biomarkers.   "
20207|NCT03021057|"     Conventional chemotherapeutic regimens designed for aggressive B-cell lymphomas are generally     less effective when applied to mature T-cell or NK-cell lymphomas. The treatment outcome for     relapsed or refractory disease is especially poor.      This is a single centre, prospective, non-randomized, open-label, phase II study to evaluate     the efficacy of pembrolizumab in patients with relapsed or refractory mature T-cell or     NK-cell lymphomas. Patients will receive pembrolizumab 200mg i.v. once every 3 weeks until     disease progression or unacceptable toxicity.      A baseline radiological assessment by positron emission tomography / computed tomography     (PET/CT) scan is obtained before commencement of treatment. Tumor response and progression     are evaluated by physical examination, standard laboratory tests, and PET/CT scan according     to standard criteria. Standard response criteria for non-Hodgkin lymphomas are used for     assessment . PET/CT scan will be done at week 12, week 24, week 36 and every 18 weeks     thereafter.   "
20208|NCT03021044|"     RATIONALE AND OBJECTIVE OF THE STUDY      Patients with low functional capacity (frail patients) with cardiovascular disease, in     particular those undergoing invasive procedures or suffering from coronary artery disease,     have a much higher adverse events, death and re-hospitalizations. and complications,     suggesting the need for a more accurate functional stratification and a more careful     evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc     physical activity intervention could be improve functional autonomy of these patients early     after discharge with benefit on long-term outcome. The present study is performed to assess     the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical     activity early after discharge in elderly patients aged 75 years and older with low physical     performance.      This is an interventional, multicenter, prospective, randomized, phase III study. The present     study is expected to enroll elderly patients admitted to hospital for acute coronary syndrome     undergoing percutaneous coronary angioplasty and stratified with SPPB score predischarge. At     the moment of discharge there will be a screening: patients with SPPB score 0-2 o 10-12 will     be exclusively followed up by clinical visit every year. Patients with SPPB score 3-9 will be     evaluated during the inclusion visit when SPPB will be repeated. If SPPB score will be 0-3 or     10-12, patients will be considered screening failure and will be followed up by clinical     visit; patients with SPPB score between 4 to 9 will be randomized to standard of care (see     below) or to an ad hoc physical activity program (see below). The aim of the study is to     demonstrate 6 months later an improvement in the SPPB score (at least 1 point) in patients     randomized to physical activity intervention versus patients randomized to standard of care.     All patients will be evaluated until 3 years after randomization.   "
20209|NCT03021031|"     The goal of this project is to provide comprehensive longitudinal assessments of a cohort of     PD patients before, during, and after DBS surgery, including neurological,     neurophysiological, and neuropsychological data.   "
20210|NCT03021018|"     The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV)     compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy     Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.   "
20235|NCT03020693|"     This study evaluates the effectiveness of an electrostimulation treatment with TENS using a     needle and a surface electrode combined with an exercise program to fasciitis plantar. Half     participants will receive invasive electrostimulation (TENS using a needle) and exercises     while the other half will receive electrostimulation placebo and exercises.   "
20383|NCT03018743|"     Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction.      Until now dapoxetine is the only approved medical treatment option and there is no second     line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of     the factors that lead to dropout is needed especially in a real-practice setting.      With this background, investigators are going to assesse the discontinuation rate of     dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical     setting throughout a follow-up period of 2 years.   "
20211|NCT03021005|"     The proposed pilot research has three aims: 1) to determine the feasibility and acceptability     of provision of HIV self-testing kit in order to increase uptake and engagement of HIV     testing among emergency department patients who decline conventional emergency department HIV     testing and to increase the engagement of HIV testing at a regular basis for those with an     increased risk for HIV (the index participants); 2) to determine the uptake and engagement of     HIV testing by provision of HIV self-testing kit; and 3) to determine the feasibility and     acceptability of HIV self-testing kit referral among partners or peers of the index     participants.      The investigators will conduct a pilot randomized study at Johns Hopkins Hospital emergency     department on (1) patients who decline routine HIV testing offer and (2) patients who are at     an increased risk for HIV. The consented patient will be randomized to HIV self-testing kit     group which the investigators will provide a free Food and Drug Administration-approved HIV     self-testing home kit for the participant to take it home or to reference group which the     investigators will not provide the self-testing kit. Consented patients in both groups will     fill out a short survey regarding their socio-demographic information as well as their     experience and perceptions regarding HIV testing. For patients who are in the HIV     self-testing kit group, they will be asked if they would like to take a free HIV self-testing     home kit home. Participants in this group will also receive information regarding how to     access I Want The Kit website to report the completion of HIV self-testing at home. For     patients who are in the reference group, a standard pamphlet regarding the importance of HIV     testing and HIV testing venues in Baltimore City used by emergency department-based HIV     testing program will be provided to the patients.      Follow-up questionnaires will inquire regarding the patient's experience regarding HIV     testing since their index visit.      When the participants in the HIV self-testing kit group in Aim 1, they will also be provided     5 referral cards for their partners and peers for them to request a free HIV self-testing kit     from the I Want The Kit website. At the 1-month phone follow-up, the investigators will ask     participants if they are able to give the referral cards to their partner(s) or friend(s),     how they think if their partner(s) and/or friend(s) will request an HIV self-testing kit from     the I Want The Kit website.   "
20212|NCT03020992|"     The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment     on the reduction of Anterior Uveitis (AU) flares in subjects with active axial     Spondyloarthritis (axSpA) and a documented history of AU   "
20213|NCT03020979|"     Malignant ascites is a severe complication of many types of human cancer. Animal and clinical     analyses have shown that angiogenesis plays a critical role in the formation of malignant     ascites. Therefore, drugs such as apatinib that target angiogenesis may control the     development of malignant ascites. The study is to evaluate the efficacy and safety of     apatinib in patients with refractory malignant ascites.   "
20214|NCT03020966|"     The purpose of this study is to determine how well two different methods of administrating     Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR)     surgery. The methods of administration are orally, via a pill that is to be swallowed, and     intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol     will reduce opioid consumption and opioid-related side effects after THR.   "
20215|NCT03020953|"     Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12     weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of     17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in     postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type     specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein     (western blotting), satellite cell proliferation and activation, Strength, functional test,     muscle protein synthese.      Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not     performed regular resistance exercise (<1 times per week) the last two years. Randomized,     controlled intervention study +/- transdermal administration of estrogen (17-β estradiol).     Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to     induce muscle hypertrophy in the legs.   "
20216|NCT03020940|"     1. National, large-scale, standardized, standardized, real-world research;        2. Prospective, single - arm open, non - interventional, registration, multi - center          clinical study;        3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the          principle of voluntary selection of 200;        4. registration of the use of cefuroxime axetil dispersion tablets patients;        5. Target sample size of 100,000 cases;        6. Exemption from informed consent for ethical review applications;        7. Antibiotic drug safety re-evaluation of large data.   "
20281|NCT03020095|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir     (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in     treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.   "
20217|NCT03020927|"     The purpose of this study is to examine whether adding a parent education component to an     existing intervention (Reciprocal Imitation Training) results in improved outcomes for     children with Autism Spectrum Disorder. Reciprocal Imitation Training (RIT) is a behavioral     intervention designed to improve spontaneous imitation skills in young children with Autism     Spectrum Disorder (ASD). Previous research suggests that it can be effective when used by     trained therapists, teachers, siblings, and parents of children with ASD. However, it is     unclear to what extent training parents to use RIT strategies in the home environment may     enhance outcomes, compared to having therapists implement RIT individually with the child.     The study will compare two different versions of RIT for young children with ASD: (1) two     60-minute weekly sessions of therapist-implemented RIT and (2) one weekly 60-minute session     of therapist-implemented RIT and one weekly 60-minute session of parent education about using     RIT in the home environment. The investigators will examine child and family outcomes between     these two intervention types. Outcomes examined will include: (1) spontaneous and prompted     imitation skills in the child with ASD, (2) social communication skills in the child with     ASD, (3) parent stress, and (4) parent and child behaviors during parent-child play     interactions.   "
20218|NCT03020914|"     Patients will be randomly assigned to either one of two groups:        1. Standard of care sedation        2. Audiovisual distraction during surgery and in the recovery room using video goggles and          headphones; patients can choose a movie from a preexisting library      Monitoring and anesthesia regimen will be standardized   "
20219|NCT03020901|"     1. Primary study endpoint Security Effectiveness        2. Secondary study endpoint Extensive use of population characteristics Clinical drug          characteristics appropriate crowd characteristics Adverse reactions susceptible          population characteristics Reveal rare, new, unanticipated and long-term adverse drug          reactions bacterial resistance Explore the advantages of teicoplanin in combination with          other antimicrobial agents Explore the opportunistic use of teicoplanin for injection   "
20220|NCT03020888|"     The purpose of this post-marketing study is to provide prospective evidence that the Magseed     and Sentimag® is effective for lesion localization in patients undergoing surgical excision     of a breast lesion and to summarize measures of product safety and performance.   "
20269|NCT03020251|"     This randomized controlled trial will evaluate the effect of a preoperative rehabilitation     program at home in patients resected for lung cancer, comparing a control group (C group)     receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a     training program at home and chest physiotherapy   "
20221|NCT03020875|"     The United States is currently experiencing an explosive opioid epidemic. In 2014 alone,     28,647 Americans died from an opioid associated overdose; the annual death toll has increased     by over 300% since 2000. The epidemic poses a complex scenario for physicians administering     treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to     severe pain. In order to reduce the patients risk for long term opioid use and the associated     side effects, physicians have begun shifting to multimodal analgesic approaches to treat     postoperative pain. These approaches have been found to be similarly efficacious, while also     reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus.      This study proposes a multimodal analgesic approach, which the investigators believe will     reduce short and long term opioid usage, the associated side effects, and the financial     burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive     pain management, however its use is limited by a high cost to perceived benefit ratio. Oral     acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV     option, and also often not feasible to utilize in the immediate post-operative period when     patients are unable to safely swallow pills. The hypothesis of this investigation is to     understand if adding intravenous acetaminophen to the perioperative care regimen after lumbar     spinal surgery will result in improved pain management in the perioperative period while     decreasing opioid usage and related complications.   "
20222|NCT03020862|"     The purpose is to evaluate exercise performance in patients with Chronic Obstructive     Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to     previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate     oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity     level.   "
20223|NCT03020849|"     In this retrospective and prospective study, the aim is to determine a score for predicting a     fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of     fibrinogen concentrates)   "
20224|NCT03020836|"     Investigators conducted a clinic-based study to determine the magnitude of uncontrolled     hypertension and current smoking in eye doctor's offices and sought to determine if referral     to care results in actions taken by the patient.   "
20225|NCT03020823|"     The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of     SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous     platinum based therapies.   "
20226|NCT03020810|"     This is a single patient expanded access, compassionate and non-emergency use study that     provides patients with severe asthma, who do not qualify for ongoing clinical trials with     dupilumab, access to this investigational treatment.   "
20227|NCT03020797|"     This is a pilot trial to test perampanel (Fycompa; Eisai, Inc.) in ALS patients. The     investigators will focus on safety and preliminary signs of efficacy. Perampanel is approved     by the FDA for treatment of seizures in patients with epilepsy. In this study, perampanel     will be used off-label for adults with ALS at an oral medication dose on the low end of the     recommended dose range for epilepsy. This study will consist of two treatments arms:     perampanel and matching placebo randomized at a 1:1 ratio. Subjects will receive medication     for 9 months.   "
20228|NCT03020784|"     Safety, Tolerability and Pharmacokinetics of PF-06818883   "
20229|NCT03020771|"     This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA) vaccine     on humans (healthy volunteers), which has been developed in Turkey and has completed     preclinical toxicology studies to be performed on experimental animals. Also, this study is a     Phase I, randomized, double-blind, national, single-center, placebo-controlled study that is     designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48)     healthy male and/or female volunteers will be participating in this study, and the study is     planned to last approximately one year.   "
20282|NCT03020082|"     The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08     (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients     Who Have Chronic Hepatitis Genotype 1.   "
20230|NCT03020758|"     This is a 2-period randomized crossover study with free-living subjects on self-selected     diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried     plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack     food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who     are representative of the U.S. population and at risk for cardiovascular disease     (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).      The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood     pressure and LDL-cholesterol, and improve artery function (assessed by standard blood     pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial     stiffness) compared to the control group and baseline.   "
20231|NCT03020745|"     GSK3389404 is being developed for the treatment of CHB virus infection. The development goal     for GSK3389404 is the establishment of a finite duration treatment that results in sustained     suppression of hepatitis B virus (HBV) replication and viral antigen production after     cessation of all treatments for CHB due to the restoration of a functional immune response in     the absence of high antigen levels. This study is a multicenter, randomized double-Blind     (sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety,     tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish     proof-of-mechanism. The study will be conducted in two parts. Part 1 plans to enroll subjects     primarily from the Asia-pacific region and will be conducted as a single ascending dose (SAD)     study with 5 planned cohorts ranging from 30 milligram (mg) to a maximum of 240 mg     GSK3389404. Within each cohort, subjects will be randomized to receive either GSK3389404 or     placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in a sequential fashion;     Cohort C1 is an optional cohort and may be dosed after Cohort C or in parallel with Cohort D.     Part 2 will be conducted as a multiple-dose, dose-ranging study. Subjects will be randomized     to different parallel dose levels and regimens or placebo. The dose levels of Part 2 will be     selected after a review of Part 1 safety but will not exceed a total monthly dose of 480 mg.     However, the total monthly subcutaneous (SC) dose of 480 mg will only be explored in a once     weekly or bi-weekly (every 2 weeks) dosing regimen. An optional Japanese part-2 sub-study is     planned. The total study duration for part 1 including screening, treatment, and     post-treatment follow-up, will not be expected to exceed 13 weeks for each subject and for     part 2, including screening, treatment and post-treatment follow-up, will not be expected to     exceed 29 weeks for each subject.   "
20232|NCT03020732|"     Platelet concentrates(PC) are used in the field of periodontology and implantology for the     content necessary key cells and growth factors to accelerate healing and to provide     regeneration. Concentrated Growth Factors(CGF) is defined as an innovative method or a new     generation PC. The purpose of this clinical study was to evaluate the clinical effectiveness     of Concentrated Growth Factor(CGF) membrane with coronally advanced flap(CAF) procedure's and     subepithelial connective tissue graft(SCTG) with CAF in the treatment of multiple Miller     class I gingival recessions (GR).   "
20236|NCT03020680|"     Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in     the body via complicated biochemical pathways. It exists in both reduced and oxidized states,     namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes.     The main function of CoQ10 is to participate in energy production. Further, the reduced form     of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free     radical induced damages to DNA, lipid, and proteins. Given that older adults have increased     production of free radicals, suboptimal antioxidant defenses toward free radicals, and a     decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of     feasible ways to increase CoQ10 status in order adults. Most supplements available for     consumers are in the oxidized form. While the ubiquinol form is also available, whether the     reduced form will be more effective to replenish CoQ10 status in older subjects remains to be     explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively     absorbed in older adults with a low antioxidant defense status. To pursue this aim,     investigators will conduct a double blind, randomized, crossover design trail with 5 study     visits (1 screening visit and 4 study visits). Ten older men (>55 y, BMI: 25-5 kg/m2) with a     compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects     will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week     washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will     be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the     oxidized form, ubiquinone in older adults.   "
20237|NCT03020667|"     The Tobacco Heating System (THS 2.2) which is commercialized under the iQOS brand name (as     described in the study protocol) in Japan is subject to an assessment program which includes     post-market studies such as the Japanese Post-Market Cohort Study.      The objectives and endpoints of this Post-Market Cohort Study will be analyzed in the study     population of adult tobacco users and never smokers in Japan. This includes:        -  Provide a perspective of tobacco product use in a real world setting, where          simultaneous use of tobacco and nicotine containing products may occur,        -  Describe population-level changes in biomarkers of exposure (BoExp) following long          duration of CC and THS 2.2 use,        -  Evaluate whether there is a difference in the levels of selected clinical risk endpoints          (CREs) between CC smokers and THS 2.2 users.      This study is divided in 2:        -  Main Study: the Main Study will describe the patterns of use of tobacco and nicotine          containing products and self-reported health outcomes and health related events in CC          smokers and THS 2.2 users. THS 2.2 users and CC smokers will be identified and invited          for participation in the study until each annual wave of 500 participants for each          product is filled.        -  Clinical Sub-Study: the Clinical Sub-Study will further assess the population level          differences in BoExp to harmful and potentially harmful constituents (HPHCs), CREs, and          self-reported symptoms and health outcomes between CC smokers, THS 2.2 users and          never-smokers, the latter group only included in the Clinical Sub-Study. THS 2.2 users          enrolled in the Main Study will be invited to enroll in the Clinical Sub-Study where          clinical assessments will be performed and biological samples (blood, serum, plasma, and          urine) will be collected. There will be two clinical study visits, which will take place          at Month 12 (Visit 1) and Month 36 post product initiation (Visit 2).      Participants will be recruited into the cohort in annual waves over a period of 4 years.   "
20238|NCT03020654|"     This study investigates the use of virtual environments presented on a head mounted display     for the rehabilitation of those suffering with visual vertigo.      The control group and treatment groups will be presented with two different sets of     environments and be given the same head and eye exercises to complete within the environment.     They will also be provided with at home exercises to complete.   "
20239|NCT03020641|"     The investigators hypothesized that applying a low intraperitoneal pressure pneumoperitoneum     (≤ 8mmHg) during laparoscopic cholecystectomy, the adverse impact on the surgical peritoneal     environment (measured as gene expression of extracellular matrix, adhesion and inflammatory     cytokine as well as oxidative stress response and apoptotic index), can be minimized and     probably clinical outcomes might be better.   "
20241|NCT03020615|"     This is a pilot study, single-blind, randomized, multicenter, therapeutic clinical trial     designed to evaluate the feasibility of enrolling infants and toddlers (9 months to 36     months) with sickle cell anemia (SCA; HbSS or HbSβ0thalassemia), regardless of disease     severity, to a therapeutic trial. A prior clinical trial at St. Jude Children's Research     Hospital (SJCRH) (BABYHUG, NCT01783990) demonstrated that a fixed dose (20 mg/kg/day) of     hydroxyurea was safe and effective in decreasing SCA-related complications in very young     children (9-18 months), and largely due to these findings, hydroxyurea is recommended to be     offered to all children (≥9 months old) with SCA, independent of disease severity.     Nevertheless, children in the treatment arm of BABYHUG continued to experience vaso-occlusive     symptoms and to incur organ damage. In clinical trials of older children with SCA,     intensification of hydroxyurea to a maximum tolerated dosage (MTD), defined by mild to     moderate myelosuppression, may be associated with improved laboratory parameters compared to     fixed lower-dosing, but the clinical benefits gained from dose intensification have not been     described. Therefore, in this trial, children in the standard treatment arm will receive a     fixed dose of hydroxyurea (20mg/kg/day), and participants in the experimental arm will     receive hydroxyurea intensified to MTD, defined by a goal absolute neutrophil count (ANC) of     1500-3000 cells/µL. This trial aims to establish a multicenter infrastructure that will     identify, enroll and randomize very young children (9-36 months) to receive fixed dose versus     intensified-dose hydroxyurea in a single blinded manner, and to obtain prospective pilot data     comparing the clinical and laboratory outcomes between the treatment arms to facilitate     design of a definitive phase III trial.   "
20242|NCT03020602|"     This phase I trial studies the side effects and best dose of ubidecarenone injectable     nanosuspension (BPM31510) in treating patients with glioblastoma or gliosarcoma that has come     back and have been previously treated with bevacizumab. BPM31510 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
20243|NCT03020589|"     Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough     levels and clinical outcomes. The primary endpoint of this study is to evaluate the     proportion of patients reaching target levels (8-10 ng/mL) on Day 3 and Day 7 after kidney     transplantation.   "
20309|NCT03019731|"     This research is being done to determine whether a home-based behavioral therapy can be     successfully used to treat tics in children with Tourette syndrome (TS). Behavioral therapy     administered by a trained therapist has been shown to be helpful in reducing tics in children     with Tourette syndrome. In this study, the investigators want to determine whether an     instructional video can provide parents of children with TS with the tools necessary to     successfully use behavioral therapy at home. The investigators also want to determine the     effectiveness of home-based behavioral therapy as compared to improvement achieved when the     therapy is provided by a trained therapist.   "
22722|NCT02988193|"     The purpose of the PRECISION study is to compare a clinical reasoning artificial intelligence     for hypertension treatment management with usual care (UC) and enhanced care (EC) in patients     with poorly controlled hypertension.   "
20244|NCT03020576|"     Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are     often not effective in restoring full function of the upper limb. Specifically, many     individuals remain with weakness in the hand, preventing its return to full use.      Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such     as the InMotion2, have been shown to be useful in restoring some motor function in the upper     limb. However, most existing devices designed to be used with the upper limb have primarily     been developed to treat the shoulder, elbow and wrist. They have not specifically addressed     hand function.      Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide     rehabilitation for patients with neurological or orthopedic deficits in hand function.     Initial clinical testing has demonstrated the practicality of using this device in a     population of stroke survivors, although further research is needed to better understand the     usefulness of the Amadeo device as compared with conventional rehabilitation methods. The     purpose of this study was to compare results of training with the Amadeo device or training     with conventional therapies.      A total of 28 subjects from two separate sites participated in the study and underwent     baseline testing of upper limb motor and sensory performance and function. Subjects were then     assigned to one of two treatment groups with a 50:50 chance of being in either group. One     group underwent training with the Amadeo device and the other group underwent training with     conventional therapy. All training sessions were 60 minutes in duration, three days/week for     eight weeks (24 total sessions). Subjects were reassessed on completion of the training     program.   "
20245|NCT03020563|"     To determine whether liposomal bupivacaine wound infiltration decreases pain scores and     narcotic use when compared to bupivacaine alone after open reduction internal fixation of     midshaft clavicle fractures.   "
20246|NCT03020550|"     This is a pilot study measuring physiologic and behavioral correlates of symptom severity in     adult patients with gastroesophageal reflux disease (GERD).   "
20247|NCT03020537|"     In this exploratory study, investigators will be looking at immune response differences     between age groups and between the two different vaccines given to identical twins and     vaccine-naive young adults.   "
20248|NCT03020524|"     A single cohort, open-label pilot study of the safety and tolerability of a single infusion     of autologous CD4+ T-cells genetically modified with an HR2, C34-peptide conjugated to the     CXCR4 N-terminus using a lentiviral vector in HIV-infected subjects. This is a first in human     study of C34-CXCR4 T cells   "
20249|NCT03020511|"     Recently it has been reported that a consistent percentage of the general population consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have celiac disease or wheat allergy. This clinical condition has been named     Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the     term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat     causes the symptoms in NCGS patients, and the investigators also showed that these patients     had a high frequency of coexistent multiple food hypersensitivity. It is also believed that     this condition is worldwide increasing, due to the evolution of wheat breeding (i.e.     consumption of wheats with high gluten content), and that ancient wheat flour varieties are     better tolerated by NCWS patients than the modern ones. This effect could be related to a     lower immunogenic stimulation of the ancient wheat than the modern ones. The aim of the study     is to evaluate the effect of a diet based on ancient grains in a closed community (i.e.     nuns from enclosed religious order) as regard to 1) main haematochemical parameters and     vitamins, 2) intestinal microbiota (bacterial flora), and 3) cytokines production from     peripheral blood mononuclear cells (PBMC), before and after the diet period (30 days) with     ancient grains.   "
20250|NCT03020498|"     In this exploratory study, investigators will be looking at immune response differences     between age groups and between the two different influenza vaccines given to identical twins,     vaccine-naive young adults and elderly participants.   "
20349|NCT03019198|"     This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients     undergoing total hip arthroplasty (THA).   "
20255|NCT03020433|"     The investigators ultimate goal is to personalize brain stimulation for stroke so outcomes of     the upper limb can be maximized for each individual patient. Several groups including the     investigators have recently theorized that personalizing stimulation so as to selectively     stimulate iM1 in mild, and cPMd in patients with greater severity would help generalize     benefits of stimulation. The investigator premise that variances in expressions of plasticity     can explain how to best stratify patients for robust, personalized stimulation.   "
20256|NCT03020420|"     This study tries to prove that Cicatricell cream significantly reduces scarring with better     wound appearance as compared to no treatment.   "
20257|NCT03020407|"     The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock     patients who are treated with ultrasound-assisted fluid management using change of the     inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared     with those treated with usual-care strategy.   "
20258|NCT03020394|"     Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients     who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness     research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality     rates. But there's no high-quality clinical studies which can confirm this. Therefore,     investigators believe that NPPV can avoid intubation in patients with severe exacerbation of     COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in     order to reduce IMV-related complications and improve patients' outcomes.   "
20384|NCT03018730|"     This is an open label switch over study to assess the safety and efficacy of PRX-102.     Patients treated with agalsidase alfa for at least 2 years and on a stable dose (>80%     labelled dose/kg) for at least 6 months. Patients will be screened and evaluated over 3     months while continuing on agalsidase alfa. Following the screening period, the patient will     be enrolled and switched from their agalsidase alfa treatment to receive intravenous (IV)     infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25% of treated     patients will be female.   "
20478|NCT03017495|"     The main objectives of this phase 1 trial are to evaluate the effect of food on the     pharmacokinetics (i.e. how long and how much a compound is present in the blood) of     ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a     CYP3A4 substrate.   "
20259|NCT03020381|"     Motor slowing and cognitive slowing are more prevalent as we age. Importantly, the presence     of both in an older person increases their risk of having dementia by ten times. Currently,     there are no clinically meaningful predictors of progression to dementia in people with mild     cognitive impairment (MCI). The main hypothesis is that subtle variations in gait while     performing a simple cognitive task is a reliable, easy to perform, and feasible methodology     to detect those older adults at higher risk of progression to dementia and also, at higher     risk of further mobility decline and falls.      Rationale. The Canadian population is aging. According to recent estimates, the proportion of     the population aged 65 and older will increase rapidly from 13% in 2005 to 25% by 2031. This     increase in proportion is accompanied by a considerable amount of disability and subsequent     dependency which has major effects on both the quality of life of older adults and their     caregivers, and on the Canadian health care system. An important goal of geriatric medicine     is to reduce the gap between life expectancy and disability-free life expectancy by reducing     disability and dependency in the later years of life. A substantial portion of this     disability stems from two major geriatric syndromes: cognitive impairment and mobility     limitation. The ultimate manifestations of these syndromes are dementia and falls.     Interestingly, these manifestations often coexist in elderly people: falling is a common     geriatric syndrome affecting about a third of older adults each year, and dementia affects     about a third of Canadians aged 80 and over. Together, dementia and falls are responsible for     much of the discomfort, disability, and health care utilization in older adults and each will     become more prevalent as older Canadians are expected to number approximately $9 million by     2031. The combined direct cost of dementia and falls for the Canadian Health System is over     $4.9 billion per year.      Establishing reliable and easy to obtain predictors to accurately identify MCI patients at     highest risk of progressing to dementia is essential first, to determine who will benefit     from additional and/or invasive testing and second, to implement preventative strategies,     including cognitive training, physical exercises, and aggressive vascular risk factors     correction to delay progression. Even a modest one-year delay in dementia incidence could     save Canada $109 billion over 30 years.   "
20260|NCT03020368|"     In this trial the investigators want to prove the efficacy and safety of a one-time topical     leech application at patients with symptomatic primary arthrosis of the first carpometacarpal     joint in comparison to the standard therapy with topical diclofenac.   "
20261|NCT03020355|"     Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in     decreasing the duration, blood loss,and complications of the third stage, against no drainage     of placental blood.   "
20262|NCT03020342|"     Early stage HCC is treated by curative surgical resection or by local ablation (such as     radio-frequency) as the current standard of care. The complete removal of clinical visible     HCC is then confirmed by imaging by MRI or CT, or by a decline of tumor marker (AFP or     PIVKA). However, despite an apparent complete removal of the HCC, those post-curative     patients frequently develop tumor recurrence at a rate ranging 10-50% within the first year.     The high rate of early HCC recurrence indicated a minimal residual HCC after the curative     therapies in a significant proportion of patients. A better and more specific biomarker for     detecting the residual HCC will improve the patients' prognosis prediction and therapeutic     plan.      To detect the minimal residual HCC, a biomarker unique to the tumor is needed. Currently, the     cell-free circulating DNA carrying tumor-specific somatic mutations has been advocated as a     promising one. It has been applied to investigate the tumor responses or resistances to     cancer therapy. However, currently it is restricted to detect or follow only large advanced     cancer, because of the difficulty in separating or enriching the cfDNA with tumor-specific     mutations from the cfDNA from normal cells. In this project, the investigators proposed that     one class of somatic mutation in HBV-related HCC, namely the insertion mutagenesis by     integrated HBV DNA, could be adopted to circumvent this difficulty. HBV DNA integration has     been found in the chromosomes of about 90% of HBV-related HCC and the integration site is     unique to individual HCC. The HBV-host junction DNA fragment from one HCC is therefore a     tumor-specific biomarker. Such fragments can be released into the circulation as cell-free     circulating DNAs, and the detection of the HBV-host chimera DNAs in the circulation is a     reliable evidence for the presence of the tumor in the patient. Therefore the cf circulating     HBV-host chimera DNA is proposed to assay any minimal residual HCC after curative therapies.   "
20263|NCT03020329|"     1. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy     works in treating children with advanced nasopharyngeal carcinoma(NPC).   "
20264|NCT03020316|"     This study will be a pilot prospective randomized study of using a peer mentor with or     without transcendental meditation as compared to usual care for women with newly diagnosed     heart disease (coronary artery disease or CAD). The study is designed to explore the effect     of these interventions on medication adherence and a number of additional outcomes. The     results of this pilot study will be used in the design of larger future trials.      The targeted population is for adult women with a new diagnosis of CAD made on the basis of a     myocardial infarction or a coronary revascularization procedure requiring inpatient     hospitalization at the New York-Presbyterian Hospital.      The overall hypothesis of this proposal is that the addition of a peer mentor to usual care     will improve self-reported medication adherence for women with newly diagnosed CAD as     compared with usual care. The further addition of meditation sessions will provide further     incremental benefit to medication adherence.   "
20265|NCT03020303|"     Individuals receiving dialysis are at risk of heart failure and heart related death. There is     an urgent need for treatments that reduce the risk of these problems in patients that require     dialysis.      Spironolactone is a pill used to prevent heart failure and related deaths in patients that do     not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes     high blood pressure and can damage the heart. Although spironolactone is very effective in     patients that do not require dialysis, we do not know if spironolactone is effective in     dialysis patients. Our research will help determine if spironolactone reduces heart failure     and heart related deaths in dialysis patients.      The purpose of this study is to determine if spironolactone reduces death or hospitalization     for heart failure and is well tolerated in patients that require dialysis.   "
20266|NCT03020290|"     Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal     lesions. This technique tends to extend to lesions for which the gold standard remains until     now the open surgery treatment (lesions TASC C and D).      The primary objective of the study was to evaluate the clinical efficacy at 12 months of the     SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D     in patients with symptomatic peripheral arterial disease. The secondary objectives are to     evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical,     morphological and haemodynamic criteria, the possible influence of calcifications and the     quality of life of patients.      The SuperA stent treatment is not specifically provided for by the Protocol but is carried     out within the framework of the care. This study is an observationnal study.   "
20267|NCT03020277|"     This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period     to explore via a specific Smartphone© application the evolution of a child's behavior over 6     months and the (psychological and social) effects of these changes on the family.   "
20268|NCT03020264|"     Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in     France.      Currently the investigators are seeing an aging of the population explained by the increase     in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the     frequency of hypoglycemia in older vulnerable patients remains poorly characterized   "
23344|NCT02980068|"     This is an open-label, single-center study to examine distinguishing features of the     structure and function of the oral and gut microbiome in healthy adult normal volunteers     compared to volunteers with PH-HFpEF in the breakdown of oral nitrate.   "
20270|NCT03020238|"     Background: Radical hysterectomy is an important therapy for early cervical cancer.     Disfunction of urinary dynamics is the most common postoperative adverse effects, which had     negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could     reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative     urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't     clear.      Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze     the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen,     Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.      Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to     randomly allocated to BiClamp group or water jet group.      Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.      Methods: All surgical patients are accessed via urinary dynamics before and four months after     NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine     volume (RUV) will be measured. For patients of RUV > 100 ml, urinary catheter will be     replaced.      Primary study endpoint: the successful rate of removing urinary catheter on the 14th day     after NSRH.      Secondary study endpoint: urinary dynamics four months after NSRH.   "
20271|NCT03020225|"     The investigators aim to test the protein bioavailability of new specific developed strain of     duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein source     and contains all the 9 essential and the 6 conditional amino acids. The investigators will     randomize 36 participants to consume equivalent protein (30gr) content of 3 whole foods     items: 1. White cheese (animal protein source, as a reference); 2. Green peas, intact, cooked     (plant protein source); 3. Wolffia globosa (Mankai), intact, cooked (plant protein source).     The foods will be consumed in the morning, following 12h fasting. The foods will be provided     with 250ml mineral water and the blood follow-up frame will be for 3 hours. Primary outcome:     Blood amino acid profile.   "
20272|NCT03020212|"     A clinical, prospective, randomized controlled trial to determine the effect of prescribing     oxygen in a group of COPD (chronic pulmonary disease) patients with PaO2 (arterial oxygen     tension) ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on     echocardiogram (which are considered manifestations of chronic hypoxia)   "
20273|NCT03020199|"     The purpose of this study is to determine whether early intervention with subcutaneous (s.c.)     secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to     prolonged symptom free periods by preventing reactivation of old lesions or ultimately     totally hindering the occurrence of new lesions, i.e., changing the natural course of the     disease (Main Study).   "
20274|NCT03020186|"     Mediterranean (MED) diet, richer in plants/seeds (and dietary polyphenols) and low in     processed meat (green-MED diet) may have a pronounced beneficial effect on age-related     declines that begin in middle age, reflected by changes in adiposity, cognitive function, and     cardiometabolic risk. The investigators hypothesize that long-term intake of this diet will     significantly potentiate the effects of a healthy lifestyle (physical activity and     Mediterranean diet), constituting a powerful strategy to halt or even reverse the progression     of several age-related processes related to adiposity, cardiometabolic health and cognition.     The investigators further hypothesize that lifestyle intervention might modify the gut     microbiota profile and that autologous fecal microbiota supplement derived from the time of     maximal weight loss might halt the expected subsequent regain phase.   "
20275|NCT03020173|"     This study aims to discover the connection between BMI and oocyte and granulosa     consistencies.   "
20276|NCT03020160|"     This multicenter, open-label, non-randomized study will assess the efficacy, safety,     pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams     per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without     inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK)     run-in part followed by an expansion part.   "
20277|NCT03020147|"     The Randomized Control Trail included 4,172 low-birth weight children between February 2008     and September 2013 in Bissau. The children who were included in the RCT and who are living in     the Bandim Health Project study area will be visited. The study assistants will ask about the     health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar     status of both child and parents will be checked.   "
20278|NCT03020134|"     The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in     Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy     Participants   "
20283|NCT03020069|"     The purpose of this study is to determine that continuous glucose monitoring systems (CGMS)     with intensive real time feedback about diabetes management from medical staff to the patient     will affect motivation and/or behavior, in adolescents with poorly controlled type 1     diabetes. Investigators hypothesize that short-term CGMS use with feedback (and/or lack     thereof) and patients' sense of self-efficacy   "
20284|NCT03020056|"     This is a randomized controlled trial to investigate the effect of cataract surgery on the     household economy of cataract patients in rural area of Southern China.   "
20285|NCT03020043|"     Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option.     In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on     mortality and morbidity in a routine clinical setting in germany, the investigators initiated     this Frankfurt registry.   "
20310|NCT03019718|"     The purpose of this study is to implement the internet-based aftercare program 'GSA-Online     plus' in several rehabilitation clinics with patients of different indications     (psychosomatic, orthopedic and cardiovascular diseases). 'GSA-Online plus' is an     internet-based aftercare program for patients with work-related problems or anxieties facing     return to work after longterm sickness absence and inpatient rehabilitation. The patients     have access to various exploratory and motivational videos on the study website until their     inpatient rehabilitation ends. Afterwards, they start a 12-week writing intervention based on     a psychotherapeutic concept, the psychodynamic 'Core Conflictual Relationship Theme Method     (CCRT)'. Patients write weekly online diary entries which are answered by anonymous online     therapists usually within 24 hours. In a previous randomised controlled trial the efficacy of     the intervention was determined, whereas the current study focuses on the implementation and     realization in a naturalistic setting (effectiveness).   "
20286|NCT03020030|"     Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The     cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in     the bone marrow (along with other blood cells) and help fight infections. In ALL, the     cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out     the normal blood cells in the bone marrow so that the body cannot make enough normal blood     cells. ALL is always fatal if it is not treated. With current treatments, most children and     adolescents with this disease will be cured.      The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are     used, and the doses of the drugs, are similar but not identical for all children and     adolescents with ALL. Some children and adolescents receive stronger treatment, especially     during the first several months. A number of factors are used to decide how strong the     treatment should be to give the best chance for cure. These factors are called risk     factors. This trial is studying the use of a new, updated set of risk factors to decide how     strong the treatment will be. The study also will test a new way of dosing a chemotherapy     drug called pegaspargase (which is part of the standard treatment for ALL) based on checking     levels of the drug in the blood and adjusting the dose based on the levels.   "
20287|NCT03020017|"     The purpose of this research study is to evaluate the safety of the study drug, NU-0129,     based on Spherical Nucleic Acid (SNA) platform when infused in patients with recurrent     glioblastoma multiforme or gliosarcoma. The SNA consists of nucleic acids arranged on the     surface of a small spherical gold nanoparticle. This is a first-in-human trial to determine     the safety of NU-0129. NU-0129 can cross the blood brain barrier (a filtering mechanism that     carry blood to the brain). Once within the tumor, the nucleic acid component is able to     target a gene called Bcl2L12 that is present in glioblastoma multiforme, and is associated     with tumor growth. This gene prevents tumor cells from apoptosis, which is the process of     programmed cell death, thus promoting tumor growth. Researchers think that targeting the     Bcl2L12 gene with NU-0129 will help stop cancer cells from growing.   "
20288|NCT03020004|"     The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of     Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive     Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.   "
20289|NCT03019991|"     The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose     (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and     day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.   "
20290|NCT03019978|"     The proposed study will include an analysis of data for residents of Pennsylvania who are age     21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in the     Commonwealth's Adult Community Autism Program (ACAP). The individuals enrolled in the program     will be administered a standardized assessment battery quarterly for two years. The proposed     study will analyze the data gathered during each of the assessment periods in order to aid in     service/treatment planning, assess for individual improvements, and ultimately measure     treatment outcomes.   "
20291|NCT03019965|"     This study evaluates the efficacy and safety of the administration of betalactam antibiotics     in prolonged infusion compared to intermittent infusion in children with sepsis. Half of     participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or     extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or     meropenem in intermittent infusion.   "
20292|NCT03019952|"     An analysis of data for adolescents and young adults diagnosed with Autism Spectrum Disorders     (ASDs) who are evaluated as part of the Care Coordination, Assessment, and Responsive     Engagement for transition-aged adolescents (t-CARE) program which replaced the former Autism     Life Care Model (ALCM), which was a clinical program implemented between Fall 2014 and April     2016. The individuals enrolled in the program will be administered a standardized assessment     battery during each visit with the care coordinator or study coordinator. The proposed study     will analyze data gathered during each of the assessment periods in order to check the     efficacy and viability of the protocol.   "
20293|NCT03019939|"     AML/MDS and their treatment may weaken participant's immune system and may make participant     more likely to develop invasive fungal infections (IFIs).      The goal of this clinical research study is to learn if isavuconazole can help prevent     invasive aspergillosis (IA) and other IFIs in patients with AML/MDS. The safety of this drug     will also be studied.   "
20294|NCT03019926|"     A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is     associated with an increased risk of relapses, hospitalizations, morbidity and poor renal     prognosis.      New treatment protocols exist and are indicated in second intention in case of good     compliance. An assessment of therapeutic adherence is therefore essential.      Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been     prescribed with Plaquenil (hydroxychloroquine), will be included in the study.      The study primary objective is to determine risk factors for non-observance      The secondary objectives are to:        -  Measure the observance rate of patients with systemic lupus in Martinique.        -  Describe the parameters that influence observance: evaluation of the disease and          associated comorbidities, psychosocial assessment, assessment of the doctor-patient          relationship, evaluation of the disease representations.   "
20366|NCT03018964|"     The purpose of this study is to determine safety of solo surgery in single incision     laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator     assisted SILC   "
20311|NCT03019705|"     The purpose of the current explorative study is to examine the effects of health-related     internet use in individuals with pathological health anxiety using ambulatory assessment. In     a naturalistic setting participants answer over a seven-day period questionnaires about their     health-related internet use and its effects on affect, health anxiety and symptom severity in     their usual daily lives.   "
20385|NCT03018717|"     Information and communications technologies (ICT) currently constitute a key element in the     innovation and improvement of providing health-care to frail populations with advanced     chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven     conclusively. The investigators are going to carry out a multi-center, randomized, parallel     groups, phase III clinical trial in adult patient with heart and/or lung advanced     diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of     bio-parameters added to optimal standard of clinical care (shared clinical care plan)     compared to the shared clinical care plan exclusively.   "
20295|NCT03019913|"     Muscle wasting is a significant problem in critically ill patients, with reported losses of a     half to three percent per day over the first ten days (for an average 70kg person this     equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive     care unit (ICU) and the loss of lean tissue have been associated with negative clinical     outcomes, including increased incidence of infections, length of stay, mortality and muscle     weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients     with low muscularity on admission, 2) to help understand the factors impacting muscle loss     and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass     in this population.      The measurement of lean body mass in patients admitted to the ICU is challenging however, due     to the large fluid shifts that occur in this population and logistical issues in moving     patients to specialised machinery for body composition analysis. Currently, there is no     validated method for accurately assessing a patient's muscle mass at the bedside in the     intensive care setting. It is therefore important to investigate the accuracy, feasibility     and reliability of bedside methods such as subjective physical assessment of muscle mass, mid     arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this     population who are primarily bedbound. In order to do this, a critical comparison is required     between these methods and muscularity assessed by a reference body composition method, such     computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the     abdomen area utilising abdominal CT images has been shown to be highly representative of     whole body skeletal muscle volume.      We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a     CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be     to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound,     bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated     with skeletal muscle mass quantified by a reference method (CT image analysis).   "
20296|NCT03019900|"     The purpose of this study is to describe current practice on red blood cell transfusion in     critically ill patients of intensive care units located in high altitude areas   "
20297|NCT03019887|"     To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than     1000mg/day and to evaluate relationship between relapse and cognitive function.   "
20298|NCT03019874|"     The main focus of this observational study is to analyze the possible effects of cranberry     dietary supplements on the intestinal microbiota in women with recurrent uncomplicated     urinary tract infections. In a secondary analysis the possible influence of the microbiota     changes on the recurrence frequency in the follow-up should be analyzed.   "
20299|NCT03019861|"     The main goal of this randomized, controlled clinical pilot study is to evaluate the efficacy     of an individual Ayurvedic nutritional counseling (according to tradition) compared to an     individual conventional dietary advice (according to the German Nutrition Society - DGE) in     patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy     elements, which patients can self-implement independently in the home environment, can     achieve sustainable therapy effects.   "
20300|NCT03019848|"     The purpose of this study is to determine if the oral supplementation with curcumin reduces     proteinuria, improves the redox and pro-inflammatory state in patients with chronic kidney     disease associated to Diabetes mellitus.   "
20301|NCT03019835|"     The antagonism of neuromuscular blocking agents (NMBA) (or curares), as well as the     antagonism of other drugs used in anesthesia, is a major challenge for the speciality.      Residual paralysis is indeed a risk factor for post-operative morbidity and mortality and     antagonization of curares at the end of the procedure is associated with a reduction in     mortality .      Its use should be as large as possible and its contraindications are extremely rare.      The antagonism of the NMBA reduces the duration of the neuromuscular block and the     complications that are associated .      In this study, the investigators use mivacurium (or Mivacron) as non-depolarizing curare and     neostigmine as an antagonist.      Neostigmine reduces the duration of the neuromuscular block induced by mivacurium, By     reducing the breakdown of acetylcholine, neostigmine induces an increase in acetylcholine in     the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular     blocking agents, and reverses the neuromuscular blockade.      But the use of neostigmine in current practice is not very widespread in this clinical     situation.      The reduction in the duration of the block is significant in comparison with a spontaneous     recovery .      Moreover, spontaneous recovery is not always complete and sometimes very long.      Nevertheless, its action is effective and this study could support this use but also specify     the duration and the quality of the return to normal of the neuromuscular transmission.   "
20302|NCT03019822|"     The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation     on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we     predict associations between subjective effects/alterations in emotion processing tests and     functional imaging (fMRI) activity.   "
20303|NCT03019809|"     Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF     as additional agents for prevention of graft failure after transplantation with TCR     alpha/beta grafts depletion in patient with Wiskott-Aldrich syndrome.   "
20304|NCT03019796|"     To analyze the effects of different exercise training modalities (continuous, intervallic,     and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome     patients when this training interacts with their habitual medication.   "
20305|NCT03019783|"     The investigators hypothesize that older subjects with HIV randomly assigned to atazanavir     will have increased bilirubin levels, reduced oxidative stress, and improved flow-mediated,     endothelium-dependent vasodilation compared to subjects not switched to atazanavir.   "
20306|NCT03019770|"     The purpose of this study is to test a clinical Decision Aid that will help patients and     providers determine if pre-exposure prophylaxis (PrEP) is the right decision. The Decision     Aid will be tested in both clinical and non-clinical settings with 80 patient-provider dyads.     The investigators hypothesize that the use of the Decision Aid will reduce patient decisional     conflict. The investigators predict that it will increase patient and provider knowledge of     and intent to initiate PrEP.   "
20307|NCT03019757|"     The study is designed to characterize the clinical, neuropsychological, polysomnographic, and     neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and     Parkinsons' Disease.   "
20308|NCT03019744|"     Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled     Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in     post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care     rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation     to assist normal arm movements during rehabilitation of the upper limb in persons with stroke     will improve the movement quality and success and thus induce recovery at the body functions     level (impairment) and the activity level (disability) of the International Classification of     Function (ICF) superior to that induced by usual care rehabilitation.   "
20312|NCT03019692|"     Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on     ultrasound in extremely preterm infants. Papile classification is commonly used to grade the     severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including     periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to     be associated with adverse neurodevelopmental outcomes.      However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm     infants has not been well described.      Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is     not well established.      The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and     follow their radiological, cognitive, motor and functional outcomes.      The study will focus on postnatal files, and on images performed as part of the child's     follow-up during hospitalization and after discharge.   "
20313|NCT03019679|"     In this study the investigators aimed to investigate whether there is a relation between     polycystic ovary syndrome and serum endocan levels.   "
20314|NCT03019666|"     This is a phase I trial with pilot expansion of HLA-haploidentical or HLA-mismatched related     donor nicotinamide expanded-natural killer (NAM-NK) cell based therapy for patients with     relapsed or refractory multiple myeloma (MM) or relapsed/refractory CD20-positive non-Hodgkin     lymphoma (NHL). The primary endpoint of the study is to determine the maximum tolerated dose     (MTD) of NAM-NK cells while maintaining safety.   "
20315|NCT03019653|"     The purpose of this study is to look at kidney function and hormonal function in patients     with a history of heart failure and kidney dysfunction, and to see how the use of a new drug,     ANX-042, affects those functions.   "
20316|NCT03019640|"     The goal of this clinical research study is to learn about the safety of giving immune cells     called natural killer (NK) cells with chemotherapy and a stem cell transplant to patients     with non-Hodgkin's lymphoma. Participants will receive an autologous stem cell transplant (a     transplant of your own bone marrow or blood cells).      Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous     cells. Researchers believe that the NK cells you receive from the donor may react against the     non-Hodgkin's lymphoma cells in your body, which may help to control the disease.      The NK cells will be separated from a donor's umbilical cord blood. These separated NK cells     will then be grown in the lab to increase the number of NK cells that can be given to     participant by vein. If certain types of unwanted T cells are growing too much, an     investigational device called a CliniMACS system will be used to filter out the unwanted T     cells using a magnet.   "
20317|NCT03019627|"     The phase II study is a single-center, randomized, double-masked, parallel-arm,     vehicle-controlled trial, designed to evaluate the safety and efficacy of Recombinant Human     Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily     for 8 weeks in patients with dry eye.   "
20318|NCT03019614|"     This was an open label, randomized, single dose, three period crossover pharmacokinetic study     of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups     (Group 1, n=18 and Group 2, n=12).   "
20319|NCT03019601|"     A specific organized program utilizing peers in the PMTCT clinic who provide family planning     information and support to HIV infected mothers was compared to providing standard family     planning messages currently used in the clinic.   "
20321|NCT03019575|"     The purpose of the study is to investigate whether corifollitropin alfa (MK-8962),     administered in combination with human chorionic gonadotropin (hCG), increases the testicular     volume in adolescent males aged 14 to <18. In addition, the study will evaluate participants     for the development of corifollitropin alfa antibodies over the course of 64 weeks of     treatment.   "
40549|NCT02754843|"     The purpose of this study, which contains a series of successive study parts, is to     methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality     control prior to each product launch.   "
20322|NCT03019562|"     Oxycodone is one of the most widely used opioids for pain treatment. Many studies     demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the     efficacy and side effects of bolus intravenous of oxycodone injection compared to those of     fentanyl in patients after total hip replacement surgery.   "
20323|NCT03019549|"     The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The     amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken     with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be     measured. Information about any side effects that may occur will also be collected.      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.      Screening will be undertaken within 45 days prior to enrollment.   "
20325|NCT03019523|"     This is a cross-over design study in which subjects arrived to the lab and were assigned a     supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing     along with a questionnaire. Thirty minutes after ingestion subjects filled out the same     questionnaire, completed a reaction time test, followed by a series of dynamic exercises.     After the last exercise was finished subjects filled out the questionnaire, completed another     reaction time test and repeated the series of dynamic exercises. Following the exercises,     subjects filled out the questionnaire and completed a fourth round of reaction time testing.     In total subjects would complete 2 rounds of dynamic exercises and 4 rounds of reaction time     testing with heart rate being recorded before and after the dynamic exercise rounds. Subjects     were told to wash-out for 7 days and return to the lab to complete the same testing but on     the alternative supplement.   "
20353|NCT03019146|"     The incidence of conditions requiring surgical intervention increases with age, however there     is a reported decline in the rates of elective surgical procedures in those over 65. This is     associated with older patients being described as less fit and more at risk of     postoperative complications, leading to decreased provision of surgical care to those at     need. Exercise interventions have the potential to reverse some of the decline in     cardiovascular fitness associated with aging and improve the elderly's' fitness for surgery     and potentially allow increased access to surgical care for those most in need of it.   "
20354|NCT03019133|"     The goal of the project is to determine the effects of noise masking and noise reduction on     stress related physiological parameters in critically ill patients admitted to the intensive     care unit.   "
20326|NCT03019510|"     Morning hyperglycemia plays a role in the future development of insulin resistance and type 2     diabetes (T2D) (8) and is associated with numerous microvascular and cardiovascular     complications and renal disease. These augmented morning glucose levels are due to an     elevated endogenous glucose production (EGP), as a result of a loss of coordination between     glucose levels and insulin secretion, and possibly hyperglucagonemia during the overnight     period. Exercise stimulates glucose uptake and increases insulin sensitivity acutely, and may     be the best lifestyle intervention to minimize the nocturnal rise in glucose levels.     Prescription of the timing of exercise relative to a meal and/or to the overnight period may     be particularly critical for individuals that have impaired fasting glucose (IFG) levels.     Surprisingly little is known about the overnight period when elevated EGP and the synchrony     between glucose and c-peptide/glucagon levels becomes disturbed. This novel study will     provide insight into the hormonal/metabolic milieu of a dinner meal, the evening and     overnight period that occurs in non-obese, OB and OB+IFG individuals; it will also establish     if the timing of exercise can attenuate nocturnal glucose elevations, and if this is     associated with improved hormonal synchrony. This project will compare EGP, β-cell function     and hormonal responses between morning and evening exercise on the postprandial and overnight     period in obese individuals with/without IFG levels. Fifty-four subjects will be studied     during the evening meal (EGP and β-cell function), postprandially and through the overnight     period (1600-0700 h), allowing us to examine some of the potential mechanisms for the     elevation in overnight glucose levels. This is the first study that will examine this issue     from pre-dinner through the night while previous studies have only examined chronically     fasted individuals and this study will lay the groundwork for understanding the pathology of     the predawn phenomena in OB+IFG individuals. These potentially translational findings may     impact the efficiency of physician communication to patients concerning exercise. These     investigators are one of the few groups that study subjects through the overnight period and     have the facilities and capability to do this research.   "
20327|NCT03019497|"     The purpose of this study is to evaluate the efficacy of a form of cognitive behavioral     therapy (CBT) in a population of individuals with PTSD and common related problems     (depression, anxiety or sleep disorders, pain, psychosocial stressors, low social support,     substance use disorder). Half of the participants will receive a cognitive behavioral therapy     with specific modules for the treatment of related problems (CBT-E) and the other half of     participants will receive therapy without specific modules (CBT-C).      The main assumption is that participants treated in the CBT-E condition will present a lower     level of symptom intensity of PTSD and a higher remission rate than those in the CBT-C     condition during the post-treatment assessment. As a secondary objective, an analysis of the     different parameters of effectiveness of the two forms of CBT (e.g., average number of     sessions required to reach remission, treatment strategies used) will be performed.   "
20328|NCT03019484|"     The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy     promotion intervention. More specifically our objectives were to: explore changes in     self-efficacy following the intervention; explore changes in the initiation and maintenance     of breastfeeding following the intervention.   "
20329|NCT03019471|"     The investigators aim to collect tumor DNA out of blood of cancer patients. If this is     successful this could lead to the development of a cancer test in blood in the future, which     is less invasive than current diagnostic methods.   "
20330|NCT03019458|"     To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen     among X-linked Dystonia Parkinsonism patients.   "
20331|NCT03019432|"     In this study, the researchers will investigate whether the E-effect is present in stroke     subjects both on the subjective visual and postural vertical test. In addition, researchers     will investigate the impact of the loss of different sensory information sources on the     sensory reweighting strategies and perception of verticality by measuring the effect of     somatosensory loss on the E-effect.   "
20332|NCT03019419|"     To investigate the safety and the efficacy of perampanel in patients with sporadic     amyotrophic lateral sclerosis   "
20333|NCT03019406|"     Primary Objective:      To evaluate the safety profile of neoGAA in patients with infantile-onset Pompe disease     (IOPD) previously treated with alglucosidase alfa.      Secondary Objective:      To characterize the pharmacokinetic profile of neoGAA and to evaluate the preliminary     efficacy of neoGAA in comparison to alglucosidase alfa.   "
20334|NCT03019393|"     This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin     bound iron (NTBI)   "
20335|NCT03019380|"     Wondertip is a silicone single use device with a coil end, designed for the purpose of     evacuating impacted cerumen of external ear canals. This trial aims at testing the safety and     efficacy of this device. The participating investigators will be ENT doctors with the skill     of examining the treating ear problems.   "
40765|NCT02752035|"     The purpose of this study is to determine the efficacy superiority of ASP2215 and/or ASP2215     plus azacitidine versus azacitidine as measured by overall survival (OS) and event-free     survival.   "
20336|NCT03019367|"     This study is being done to find out whether umbilical cord milking (UCM) is at least as good     as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent     death in premature newborns. The investigators will study short and long term outcomes of     infants delivered before 32 weeks gestation that receive either UCM or DCC.   "
20337|NCT03019354|"     In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion     ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen     therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It     has physiological effects: reduction of anatomical dead space, positive end expiratory     pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The     hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia     could improve lung function and prevent lung atelectasis.   "
20338|NCT03019341|"     The prevalence of nausea and vomiting after the administration of non-ionic contrast media     has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk     factors of nausea and vomiting after the exposure to the non-ionic contrast media for     computed tomography examinations in adults.   "
20355|NCT03019120|"     This study will evaluate the effect of vitamin D supplementation on the neurocognitive     function of older people with lower than normal levels of vitamin D at baseline   "
20356|NCT03019094|"     Interventional, Prospective, Open Label study   "
20357|NCT03019081|"     The researchers propose to utilize a pharmacological approach involving infusions of the     sympathomimetic agent isoproterenol to repeatedly trigger cardiorespiratory sensations and     anxiety during meal anticipation, to facilitate the development of tolerance or a reduction     of the anxiety/fear response in individuals with anorexia nervosa. The investigators aim to     conduct a proof of principle study to assess for evidence of initial efficacy of this new     treatment approach. As a comparator condition, the researchers propose using repeated     administration of saline infusions.   "
20339|NCT03019328|"     The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is     a major step towards prevention of food allergy. However, because that finding was from a     clinical trial in a very select population, there are several major questions that must be     answered in order to implement these findings into clinical practice without causing more     harm than good. These questions include who, if anyone, should be screened prior to early     introduction for peanut allergy, how this screening should be done, and what quantity of     peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer     these critical questions so that the potential of these recent findings can be realized. To     that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be     given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of     peanut IgE, and then will be followed for assessment of peanut consumption and development of     peanut allergy until 3 years of age.   "
20340|NCT03019315|"     Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit     of standard chemotherapeutic regimens including taxane has not been established. This study     was conducted to investigate the influences of regimens of front-line chemotherapy on on     recurrence and survival for early-stage ovarian adenocarcinoma. Further, the study will     analyze cost-effectiveness of different regimens   "
20341|NCT03019302|"     A prospective study evaluating the timing, incidence and relationship of commonly occurring     complications related to the use of peripherally-inserted central catheters. All subjects     will receive PICC access using the Arrow PICC with Chloragard Technology.   "
20342|NCT03019289|"     The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R     (optional) in the living human brain. No formal statistical analysis will be conducted   "
20343|NCT03019276|"     To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a     reasonable regimen for subsequent research.   "
20344|NCT03019263|"     Menopause is usually associated with an increase in body weight, a change in body composition     and fat distribution and a large number of cardio-metabolic changes, such as hypertension,     reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these     complications is the modification of dietary habits and lifestyle in terms of physical     activity. Besides, there is also a growing interest in complementary therapies (i.e.     nutraceuticals) that can be used alone or in combination to achieve more consistent results.     In this context, preliminary evidence supports the potential role of some compounds of     vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of     their use, the evidence from good quality trials is limited.   "
20345|NCT03019250|"     Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids,     selenium, and antioxidants has been suggested to reduce infections and improve recovery from     critical illness. However, the effects of colostrum on clinical outcomes in critical ill     patients has not been investigated. In current trial, intensive care unit patients with     enteral feeding will receive either enteral colostrum or maltodextrin as placebo.   "
20346|NCT03019237|"     In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or     intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before     nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples,     specific and total IgE levels will be assessed.   "
20347|NCT03019224|"     Introduction: The pain sensitivity associated with whitening is the main problem reported by     patients during dental whitening, and the use of desensitizing dentifrices is an alternative     for the treatment of sensitivity.      Objective: To evaluate clinically the influence of desensitizing dentifrices applied through     a plastic tray, reducing the pain sensitivity and color variation caused by the technique of     in-office dental whitening, through a controlled double-blind clinical study.      Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30     years of age, without gender distinction, who underwent in-office dental whitening using 35%     hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions with     a one-week interval between them. The volunteers used in the night for each bleaching session     a plastic tray for 4 hours containing one of the dentifrices related to the experimental     groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy); Group 2 (Active     control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever); Group 3     - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine     (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium nitrate (NP) and     sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel, GlaxoSmithKline). The     evaluation of the sensitivity associated with the times of use of the plastic tray in the     first session (S1: sensitivity before the tray, S2: sensitivity after the tray), in the     second session (S3: sensitivity before the tray, S4: in the third session (S5: sensitivity     before the tray, S6: sensitivity after the tray) used the analog numerical scale with scores     from 0 to 10 and for the color evaluation the spectrophotometer (Easyshade, Vident, Brea, CA,     Obtaining the data that were used in the CIELab system. The data were submitted to the     multivariate analysis of variance (MANOVA) with repeated measurements and Lambda Wilks test     with a 5% probability level to differentiate the groups. In addition, the factorial variance     analysis (ANOVA) in one criterion was applied. Values of p <0.05 were considered     statistically significant.   "
20348|NCT03019211|"     This is a pilot randomized control trial with single blinding of the assessor that will be     conducted in two nursing homes residence to evaluate the applicability of a physical exercise     program performed in an aquatic environment compared with the same realization but land-based     to reduce falls in the institutionalized old people. The secondary objectives are to study     the applicability of the intervention in improving balance, function, gait mobility, muscle     strength of the lower limbs and the perception of the intervention.   "
20350|NCT03019185|"     This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and     efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2     portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of     the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180     patients.   "
20351|NCT03019172|"     RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus     reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure     in women with non complicated acute cystitis who receive probiotics for 12 days compared with     the frequency in women who receive placebo.   "
20352|NCT03019159|"     The objective of the study is to determine whether tele-consulting for the follow up of     patients with renal failure under peritoneal dialysis would not increase the risk of     experiencing a severe adverse event   "
20451|NCT03017859|"     A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC)     in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to     continuous positive airway pressure (CPAP) treatment.   "
20358|NCT03019068|"     This retrospective study aims to assess, on a large number of clinical trials (CT), the     usefulness of converting CT eligibility criteria into standardized queries performed on     commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate     the potential recruitment of clinical trials centers.      Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against     thorough examination of patient files.      Primary objective is to estimate the precision of the prediction system, i.e. ratio of     numbers of eligible patient files / numbers of candidate patient files.      As secondary objectives, the study aims:        -  to measure the recall rate or sensitivity of the system: ratio of number of candidates          patient files / number of recruited patients;        -  to measure the ability of coding: proportion of codable criteria (inclusion criteria or          non inclusion criteria) into normalized language;        -  to measure the time required for coding criteria and the time required to execute the          queries on the national DRG database;        -  to evaluate the reliability of coding process by an independent coding of a random          sample of 30 protocols;        -  to analyse influence of characteristics of the clinical study (design, disease, ...) and          of the investigation site (volume, teaching status, ...) on the precision and          sensitivity of the prediction system.   "
20359|NCT03019055|"     This is a phase 1, interventional single arm, open label, treatment study designed to     evaluate the safety and feasibility of infusion of autologous T cells engineered to contain     an anti-CD19 and anti-CD20 scFv coupled to CD3ζ and 4-1BB signaling domains in patients with     relapsed and/or refractory CD19 or CD20 positive B cell malignancies   "
20360|NCT03019042|"     This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving     symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal     disorder.   "
20361|NCT03019029|"     The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir     PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with     pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare     these results to non-amyloid diseased controls.   "
20362|NCT03019016|"     The primary objective of this study is to retrospectively compare the perioperative and     short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal     anastomosis in minimally invasive right colectomies for benign and malignant disease.      The secondary objective of this study is to retrospectively compare the rates of incisional     hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.   "
20363|NCT03019003|"     This is a non-randomized, open-label, Phase Ib/II study to assess the safety and efficacy of     azacitidine, durvalumab (MEDI4736), and tremelimumab combination therapy in the treatment of     patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck     (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or     anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is     studying drugs that can boost the participant's immune system against the cancer cells as a     possible treatment for head and neck cancer.      The study interventions involved in this study are:        -  Azacitidine (Vidaza)        -  Durvalumab (MEDI4736)        -  Tremelimumab   "
20364|NCT03018990|"     To investigate the effects of acute alcohol challenge on the gut and liver axis.   "
20365|NCT03018977|"     Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic     effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use     of the agents can lead to withdrawal symptoms when the drugs are weaned.      Prior study showed the longer duration of sedative drugs, cumulative dose of medications and     younger age were the risk factors of withdrawal syndrome. Additional, some study showed the     sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide     standardized sedative weaning protocol including our hospital. The objectives in this study     are to establish the sedative weaning protocol and to compare the protocol sedative weaning     with the usual care weaning.   "
20367|NCT03018951|"     The purpose of this study is the development of, and two stages of pilot testing of, a tool     designed to assess frailty in older adults with a diagnosis of a functional mental illness.     During the tool's development stage, participants' input, ideas and feedback will be sought     to inform the tool's design. In the first pilot test the comprehensibility, acceptability and     feasibility of the tool will be established. The tool will be amended based on information     gained in the first pilot test. In the second pilot test the comprehensibility, acceptability     and feasibility of the revised tool will be established. Reliability of the tool will be     explored and preliminary examinations of both the interpretability and construct validity of     the tool will be completed.   "
20368|NCT03018938|"     The purpose of this study is to compare the effectiveness of basal insulin analog and insulin     analog mid mixture in Chinese participants with type 2 diabetes mellitus.   "
20369|NCT03018925|"     This study aims to characterize the changes on intestinal microbiota pattern associated with     the use of golimumab in order to determine if intestinal microbiota markers may correlate     with golimumab therapeutic effect in patients naïve & non-naïve to anti-TNF treatment   "
20370|NCT03018912|"     Sleep disorders are commonly under-recognized in the primary care setting and available     screening tools are often are limited. The study inestigators hypothesize that the use of a     novel subjective sleep vital sign (VS) will improve recognition of patients with sleep     disorders and can be utilized to track outcomes to sleep therapy.   "
20371|NCT03018899|"     This prospective, randomized study is aimed to assess the efficacy and safety of     paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The     investigators suppose that paravertebral block is not inferior in controlling the     perioperative pain for percutaneous nephrolithotomy compared to epidural block.   "
20372|NCT03018886|"     The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus     arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth     hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against     the IS 98/574 from the World Health Organization. A specific aim was to study the effect of     gender and age on the peak GH response in the GHRH+arg test   "
23345|NCT02980055|"     The purpose of this study is to analyze the percentage of root coverage in Miller class I and     II gingival recessions using connective tissue graft and collagen matrix with a two years     follow-up.   "
20373|NCT03018873|"     Patients with acute myocardial infarction (AMI) are in critical condition. When primary     percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart     failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic     preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will     investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients     short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were     randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once     RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group (without     RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine,     vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1),     echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after     PCI. Patients will be followed up by telephone at the end of one year. The major adverse     cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction,     unplanned revascularization and stroke.   "
20374|NCT03018860|"     Active phase of the second stage of labor corresponds to period of maternal expulsive efforts     (i.e. pushing). An intensive management of this phase is usual in France. This study aims to     evaluate the impact of an alternative moderate management during this pushing phase on     neonatal and maternal issues and mode of delivery.   "
20375|NCT03018847|"     The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD     disease management program manufactured and operated by HGE Health Care Solutions, LLC, in     COPD patients outside of the geographic base of HGE's existing patient population     (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to     additional geographic sites and to examine whether similar outcome measures are achieved in     patients under the supervision of health care providers that are new to the program.   "
20376|NCT03018834|"     There is no specific treatment of acute myocarditis, especially during the inflammatory     period. Interleukin (IL) is specifically involved during this period and play a role in     myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been     evaluated in myocarditis. The benefit for the patient could be important with a reduction of     heart failure and ventricular arrhythmias.      Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is     superior to standard therapy based on an association of beta-blockers and     Angiotensin-Converting-Enzyme inhibitor (ACE).   "
20377|NCT03018821|"     Although the incidence of Hepatitis B has been decreased a lot recently years, there are     still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western     medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum     hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on     TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal     mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM.     This study is a multicenter, randomized, open label, parallel group clinical trial to     evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on     chronic hepatitis B.   "
20378|NCT03018808|"     Early diagnosis and appropriate treatment for COPD patients are both critical to minimize the     progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil     (specific type of white blood cell that protects body against certain kinds of germs) level     is associated with increased risk of both moderate and severe exacerbations in COPD patients.     To date, there is insufficient amount of data that describes the prevalence of COPD in     Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five     centers located in five different Brazilian cities will provide estimation about the     prevalence of COPD in primary care and will also determine the levels of eosinophils in     subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to     be enrolled in the study.   "
20410|NCT03018392|"     The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of     20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody     Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market     outcomes study to build on the body of long-term evidence for the device.   "
20379|NCT03018795|"     Decontamination procedure is a challenging factor that affects the success of surgical     regenerative therapy (SRT) of peri-implantitis. The purpose of the present study was to     determine the impact of additional ozone therapy for the decontamination of implant surfaces     in SRT of peri-implantitis. A total of 21 patients with moderate or advanced peri-implantitis     were randomly allocated to the test group (ozone group) with the use of sterile saline with     additional ozone therapy or the control group with sterile saline alone for decontamination     of the implant surfaces in SRT of peri-implantitis. Clinical and radiographic outcomes were     evaluated at baseline and 6 months postoperatively   "
20380|NCT03018782|"     The investigators are evaluating refugee torture survivors who are receiving services at the     Weill Cornell Center for Human Rights. There are two research questions in this study: if the     current standard of care results in the under or missed diagnosis of pain and pain syndromes,     and if a validated pain screening tool can supplement the current standard protocol used in     the assessments of survivors of torture.   "
20381|NCT03018769|"     1.1 To build a TCM diagnosis and treatment database for chronic stable CAD; 1.2 To summarize     the pattern of TCM medicine used and the effect of the medication in chronic stable CAD.      1.3 To formulate a syndrome differentiation determined medicine plan based on the improvement     in the quality of life on chronic stable CAD patients.   "
20382|NCT03018756|"     Patients with idiopathic pulmonary fibrosis (IPF) experience distressing activity-related     respiratory discomfort which is challenging to manage therapeutically. Interventions such as     pulmonary rehabilitation, collaborative self-management, supplemental oxygen therapy and oral     opiate medications, are variably effective and therapeutic responses to each in individual     patients are difficult to predict. The purpose of this study is to evaluate the acute effects     of inhaled opiate therapy (fentanyl citrate) on breathing discomfort (dyspnea) in individuals     with mild-to-moderate IPF, as well as examine the potential mechanisms of dyspnea relief.   "
21935|NCT02998489|"     This is a randomized controlled trial with infants less than 34 weeks and between 1000 and     2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral     advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)   "
20386|NCT03018704|"     The focus of this application is on the improvement of services for African American (AAs)     Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate     as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than     European Americans (EAs), AAs have significantly higher rates of mortality from a variety of     alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the     higher rates of morbidity and mortality, pharmacological treatments are understudied in this     population and there is some evidence that medications are less preferred and less effective     in AAs.   "
20387|NCT03018691|"     To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1%     OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.   "
20388|NCT03018678|"     Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder     characterized by markedly elevated LDL-cholesterol (LDL-C) levels, resulting in severe     atherosclerosis often leading to early onset of cardiovascular disease. The most frequent     cause is mutation in the LDL receptor gene (LDLR). LDL-C levels remain frequently above     acceptable levels despite treatment with multiple existing lipid lowering drugs and/or LDL     apheresis. Thus, the functional replacement of the defective LDLR via AAV-based     liver-directed gene therapy may be a viable approach to treat this disease and improve     response to current lipid-lowering treatments. The purpose of this protocol is to identify     and screen potential candidates for future enrollment in a gene therapy clinical trial. No     study drug will be administered in this screening study.   "
20389|NCT03018665|"     The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing     diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese   "
20412|NCT03018366|"     The purpose of this study is to determine whether low estrogen levels in young women with     hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for     cardiovascular disease.      For this study, the investigators will measuring vascular function and immune markers on:        -  young women with hypothalamic amenorrhea (>3 months of no menstrual cycle due to low          estrogen)        -  young women with regular menstrual cycles not on hormone therapy.        -  recently menopausal women (<3 years from final menstrual period) not on hormone therapy.      Premenopausal HypoE participants will then be randomized to use either an estrogen patch or a     placebo patch (no active medicine) for 3 months, followed by estrogen or placebo patch plus     progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if     estrogen improves vascular and immune function.   "
22159|NCT02994758|"     The purpose of the study is to evaluate whether state-of-the-art technologies such and next     generation sequencing and drug sensitivity and resistance testing of patient derived tumour     tissue can facilitate research translation and improve outcome of urologic cancers.   "
20390|NCT03018652|"     Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory disease of the     airways, associated with poor health status, functional disability, significant morbidity,     and increased risk of death. In Ontario, COPD is the leading cause of hospital admission and     readmission, and costs the health system approximately 3 billion dollars annually.     Individuals with COPD experience increased 'flare-up's' (acute exacerbations) as their     disease worsens, characterized by periods of increased shortness of breath, cough, phlegm     production, and weakness. Acute exacerbations of COPD (AECOPD) are most commonly caused by     viral or bacterial infections, and often require patients to seek attention at the emergency     room or hospital for treatment. Current treatments to prevent COPD exacerbations are only     modestly effective. New therapies are needed to improve the quality of life and clinical     outcomes for individuals living with COPD.      Previous research at our center has shown a favourable effect of an antibody treatment     (immunoglobulin) on the frequency of AECOPD, doctor visits, treatments, and hospitalizations     for COPD patients. However, rigorous studies with more patients are required to confirm this     effect.      The investigators propose a clinical trial to evaluate immunoglobulin treatment in     outpatients with frequent exacerbations. In this study the investigators will determine if     immunoglobulin treatment is feasible, safe, tolerable, and potentially effective in reducing     the frequency of acute exacerbations. If this study is feasible and potentially effective, it     will inform larger studies to confirm the therapeutic effect of immunoglobulin treatment, and     would be a major advance in care of COPD.   "
20391|NCT03018639|"     Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient     Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set     assessing demographic information and pretreatment psychopathology during the days of their     inpatient stay. Beyond that, changes of therapists were documented.   "
20392|NCT03018626|"     This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of     R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse     large B-cell lymphoma   "
20393|NCT03018613|"     Chronic functional constipation is a common digestive system disease, the incidence is     increasing in recent years.It is reported that the occurrence and development of chronic     functional constipation is closely related to imbalance of intestinal flora .Moreover,types     and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota     transplantation as a new technology to rebuild intestinal flora has been used for several     disease，but the clinical efficacy of chronic functional constipation by fecal microbiota     transplantation needs to be further explored.   "
20394|NCT03018600|"     Glucocorticoid is widely used in clinical treatment. Recently, there was research about     glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active     autoimmune diseases. Through this prospective trial, the investigators wanted to know the     blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or     equivalent) in young patients (30-40 years) with active autoimmune diseases with or without     low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for     72 hours to get a better understanding of the glucose levels.   "
20395|NCT03018587|"     A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency     device.   "
20708|NCT03014505|"     Imbalance of gut bacteria is suspected to play a key role driving the progression of     cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will     determine if fecal microbiota transplantation is an effective and safe treatment for     decompensated cirrhosis.   "
20396|NCT03018574|"     Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow     University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and     age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric     disorders, IQ value of less than 70;      Study protocol:        1. Using Qiagen kit to extract the genomic DNA of 200 microliters of blood.        2. UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the          concentration of 100ng/μL or more before the next sequencing.        3. The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company          (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence.          According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene,          https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9?          Report=genbank&from=21016763&to=21070872&strand=true) (a total of 17 exons and 16          introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find          potential mutations.        4. Using the chi square analysis and other statistical methods to determine the          relationship between the mutations and susceptibility to ADHD.   "
20397|NCT03018561|"     People with cardiovascular risk (CV) factors (obesity, diabetes, etc...) or established heart     disease (such as coronary heart disease or chronic heart failure) often have cognitive     dysfunction as compared to people without CV risk factors or heart disease. Among the     mechanisms, a reduced cardiac output and cerebral blood flow in those people have been     suggested. The aim of this study was to compare resting cognitive function, maximal     cardiopulmonary function, cardiac output and cerebral hemodynamics during exercise in     patients with metabolic syndrome, coronary heart disease, or heart failure vs. healthy     subjects.   "
20398|NCT03018548|"     To monitor changes in indicators of red cell damage such as extracellular hemoglobin,     potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.   "
20411|NCT03018379|"     Considering the increasing public health concern the obesity in Morocco, the aim of the     present study was to use isotope techniques to assess body fat, total energy expenditure and     physical activity to inform design and improve interventions for the prevention and control     of obesity and related health risks such as diabetes and elevated blood pressure among     children and adolescents. Specific objectives of the trial: 1. Determine the extent of     obesity and physical activity levels in children and adolescents to design effective     interventions in the school setting. 2.Propose alternative field based techniques for     assessing body composition and physical activity that could be used in largescale situation     assessments and in assessing interventions to address obesity and risk related health care. *     For body composition: BMI z-score, waist circumference, waist measurement at height. * For     physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the     development of obesity and related health risks in schoolchildren and adolescents. 4.     Collaborate with stakeholders (government, schools and / or colleges, communities and     development partners) in designing interventions to address obesity and health risks. 5. To     recommend to stakeholders the most effective interventions in schools to prevent and combat     obesity and health risks in children and adolescents.   "
20399|NCT03018535|"     Idiopathic Membranous nephropathy (IMN) is an auto-immune glomerular disease. Recent studies     suggest that circulating auto-antibodies against the podocyte surface antigens phospholipase     A2 receptor1 (PLA2R1) and thrombospondin type 1 domain-containing 7A (THSD7A) cause the     disease in the majority of the patients. Additional autoantibodies, directed to podocyte     neo-expressed cytoplasm proteins have been described, including aldose reductase (AR),     Mn-superoxide dismutase (SOD2) and alpha-enolase (alpha-ENO).      The commonest presentation of IMN is nephrotic syndrome. Data from placebo arms of     interventional studies show that 30-40% of the untreated patients with persistent nephrotic     syndrome (NS) progress to end-stage renal disease (ESRD).      The best-validated treatment regimen of IMN is combination therapy with steroids and     cyclophosphamide, capable to induce remission of protenuria in two-third of the patients.      Despite this evidence of efficacy, there are concerns about the use of cyclophosphamide,     since it may be associated with adverse events, including bone marrow suppression, gonadal     toxicity, infections and oncogenic effects. Thus, the availability of alternative therapies     highly effective but with a greater safety profile is desirable.      Given the key role of IgG antibodies in IMN, B cell depletion may favourably impact the     glomerular disease. The anti-CD20 monoclonal antibody Rituximab is a selective B cell     depleting agent. There is evidence that Rituximab is effective in the treatment of other     diseases in which B cells play a key role, such as ANCA-related vasculitis. Observational     studies in IMN provided encouraging data; in addition, the drug seems well tolerated.      Head-to-head comparisons between Rituximab and steroid plus ciclophosphamide in randomized     clinical trials are missing.      The investigators propose this study in order to test, in a randomized controlled trial, the     hypothesis that Rituximab is more effective than cyclical steroid/alkylating-agent therapy in     inducing remission in patients with IMN and NS undergoing the initial treatment. In addition,     the levels of the above-mentioned pathogenetic autoantibodies will be measured at baseline     and during treatment. Finally, the study will compare the safety profile of steroid plus     cyclophosphamide and Rituximab by evaluating the rate and severity of adverse events   "
20400|NCT03018522|"     Primary aim of this study is to evaluate the association between postoperative cognitive     dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic     radical prostatectomy.   "
20401|NCT03018509|"     Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of     JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.   "
20402|NCT03018496|"     This study intends to examine the effect of a commercially available nutritional supplement,     Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.   "
20403|NCT03018483|"     The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from     mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.      This study is a multicenter randomized controlled open trial comparing variable, non-variable     pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation     for more than 24 hours who are able to be weaned.      The aim of the study is to determine the duration of weaning from mechanical ventilation for     each one of the above mentioned weaning methods   "
20404|NCT03018470|"     Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients.     Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that     have to be monitored are not well defined.      Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in     software which are recording the breathing pattern of patients when used. The aim of this     study is to identify ventilation parameters that are modified at the early stage of an     AECOPD.   "
20605|NCT03015844|"     This is an expanded access protocol/compassionate use single institution study designed to     determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive     neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher     priority. Response rate, toxicity, and time to progression and death will be evaluated.   "
20405|NCT03018457|"     Dental implants are a prosthetic rehabilitation device whose success depends of the bone     morphology and quality, in more the surgical procedure.      This study aims to assess whether the parameters of the trabecular microarchitecture of     alveolar bone taken from the site of the placement of the dental implant, calculated by     micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the     principle of the resonance frequency analysis at the 10th postoperative week during the     osseointegration of dental implants (secondary stability).      The cortical alveolar bone is a recognized factor in the phase of primary stability of     osseointegration. The role of trabecular bone in the secondary stability is not clearly     determined.   "
20406|NCT03018444|"     The primary objective of the present study is to evaluate the effect of HMG-CoA reductase     inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals.     Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial     glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile     acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite,     and faecal content of bile acids and gut microbiota composition.   "
20407|NCT03018431|"     We aim to show that systematic ultrasonography performed in ventilated patients suspected of     ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and     helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is     considered.      Chest CT scan is often performed before or just after admission in ICU, and usually show     abnormalities that are revealed later on standard radiographs.      This last exam is traditionally considered as the gold standard to prove new pulmonary     infiltrates, but the correlation with parenchymal consolidation is pretty low, and lead to     over-diagnosing pneumonia, thus leading to a massive and maybe sometimes unconsidered     prescription of antibiotic therapy.      Lung ultrasonography conducted systematically within the 3 first days after suspcion of     pneumonia could help making the difference between real infection-linked lesions, and banal     abnormalities following the hydric inflation of intra-thoracic organs, for instance pulmonary     edema or pleural effusion.      An independent evaluation using lung ultrasound, and analysis of CT scan acquisition when     performed, compared with the physician in charge of the patient appreciation by suggesting     him to provide his own probability of pneumonia upon routine clinical and biological datas.   "
20408|NCT03018418|"     The purpose of this research study is to determine whether the amount of radiation given to     the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing     the side effects that are seen with standard therapy.   "
22160|NCT02994745|"     The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of     Fimasartan and Atorvastatin in Healthy Male volunteers.   "
20413|NCT03018353|"     Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess     the feasibility of a HCV treatment program in the San Francisco City & County Jail. The Jail     Health Services will treat 100 patients using the FDA approved combination treatment,     sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and     after their release (if applicable).   "
20414|NCT03018340|"     To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a     selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor     (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an     inadequate response to antidepressant therapy   "
20415|NCT03018327|"     Transplant-related malignancies have emerged as one of the important complications after     organ transplantation. Some studies have shown that transplant recipients have an increased     risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic     immunosuppression in these patients, there is an increasing focus on human papillomavirus     (HPV) related cancers.      The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among     Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies     exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical     precancerous lesions among RTRs.      Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal     transplant recipients, together with identification of factors that play a role for     development of anal and cervical precancerous lesions, is important for the possibility of     early detection and treatment to prevent progression to ano-genital cancers. Cervical     cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN),     whereas high-resolution anoscopy is a newer modality for the detection of anal     intra-epithelial neoplasia (AIN). International guidelines recommend annually screening     against cervical cancer for female renal transplant recipients, but currently no     recommendation exists on screening against anal cancer.      Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and     cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal     transplant recipients and an immunocompetent control group. Furthermore to identify factors     associated with the development of AIN or CIN such as HPV type, viral load, duration of     immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking     and alcohol habits, history of genital warts and other infections, and socio-economic     variables.   "
20416|NCT03018314|"     The study population is comprise of 90 women those age varies between 18-38 year-old. The     first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the     second group will comprise of 30 women with diagnosis of unexplained infertility and the     third group will comprise of 30 women those partners with male subfertility. A 2 cc blood     sample for Kisspeptin analysis will be drawn from the antecubital vein from each     participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the     menstrual period and follicular development will be measured with serial ultrasound follow     up.   "
20417|NCT03018301|"     The purpose of this study is to investigate the analgesic effect of low-dose intravenous     ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.   "
20418|NCT03018288|"     Background:      GBM refers to a specific kind of brain cancer called glioblastoma. The standard treatment for     GBM is radiation plus temozolomide, an oral chemotherapy drug. Pembrolizumab is an immune     therapy that is now used to treat other cancers. The addition of pembrolizumab to the     standard treatment of radiation and temozolomide has been shown to be well tolerated.     Researchers want to see if adding a vaccine made from the person s own tumor will improve the     effect of the pembrolizumab. The vaccine which is developed from fresh tumor taken at the     time of surgery is called HSPPC-96.      Objectives:      To see if the adding pembrolizumab and HSPPC-96 improves the standard treatment for     glioblastoma multiforme.      Eligibility:      Adults at least 18 years old with glioblastoma.      Design:      Participants will be screened with typical cancer tests:      Brain scan      Medical history      Blood and urine tests      Questions about quality of life and symptoms      These tests will be repeated throughout the study.      Participants will have surgery to remove their tumor. A tissue sample from the tumor will be     sent to a lab. A vaccine will be made from it.      Some participants will get pembrolizumab and vaccine. Some will get pembrolizumab and     placebo. Participants will not know which they get.      Participants will get radiation for 6 weeks.      Participants will take temozolomide by mouth before each treatment.      Participants will get pembrolizumab by IV for 30 minutes 3 times over the radiation cycle.      Participants will keep taking the 2 drugs every few weeks for about a year. Some may take     pembrolizumab for an additional year.      Most participants will get the vaccine or placebo after radiation. They will get it 5 times     over 6 weeks. Some participants will continue to get the vaccine every few weeks for 1 or 2     years.      Participants will repeat the screening tests when they stop study treatment. They will also     have follow-up phone calls.   "
20419|NCT03018275|"     Background:      Atopic dermatitis (AD) is a skin disease also called eczema. It is common in children and     sometimes gets better on its own. However, chronic AD may cause asthma, food allergies, eye     infections, and sleep problems. The cause of AD might be related to bacteria that live on the     skin. Researchers want to see if introducing bacteria, R mucosa, from healthy skin onto the     skin of someone with AD helps treat the disease.      Objective:      To test the safety and activity of R mucosa for treating AD.      Eligibility:      Part 1: People ages 18 and older with AD      Part 2: Children ages 7 17 with AD      Design:      Participants will be screened with:      Medical history      Physical exam      Examination of their AD      Blood and urine tests      At the baseline visit, participants will have blood tests and photos taken of their skin.     They will get a supply of R mucosa and a memory aid to track their doses and record how they     are feeling. Part 2 participants guardians will complete questionnaires about their child s     AD.      Part 1 participants will spray R mucosa on their arm twice per week for 6 weeks.      Part 2 guardians will spray it on their child s arm twice per week for 16 weeks.      Participants will have follow-up visits to repeat some baseline tests and review their memory     aid:      Part 1: Six weeks after the baseline visit      Part 2: Four times over 16 weeks; then 2 or 3 times for 1 year      Participants will be called or emailed to discuss how they are feeling:      Part 1: About 30 days after their last visit      Part 2: About every 10 days between visits   "
20420|NCT03018262|"     Background:      Movement disorders have many different causes and symptoms. Researchers still do not fully     understand which parts of the brain are involved in fine movement. They want to learn about     which brain regions could be abnormal in people with movement disorders.      Objective:      To better understand how the brain controls movement.      Eligibility:      Healthy, right-handed adults age 18-70 years old.      Design:      Participants will be screened with a physical exam and questions about their handedness. They     may have a urine test.      Participants will have 1 or 2 clinic visits. The first visit will last about 1.5 hours. The     second will last about 3 hours.      Participants will have structural magnetic resonance imaging (MRI). A strong magnetic field     and radio waves take pictures of the brain. Participants will lie on a table that slides in     and out of a metal cylinder.      Participants may have transcranial magnetic stimulation. A wire coil is held on the scalp. A     brief electrical current is passed through the coil and creates a magnetic pulse that     stimulates the brain. Participants will wear a pair of glasses or a headband with small     sensors so researchers can track head position.      Participants will perform a simple index finger movement task.      Participants may have surface electromyography from at least two hand muscles. Small metal     disk or adhesive pad electrodes will be taped to the skin. Participants will be seated in a     comfortable chair with their hands placed on a pillow.      Participants may have an electroencephalography. A cap with small disc electrodes will be     placed on the scalp.   "
20422|NCT03018236|"     This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use     disorders. Alcohol users will be split in two groups, one will receive the active     N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The     effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress     biomarkers will be evaluated.   "
20423|NCT03018223|"     The purpose of this study is to find out if a combination of drugs (these are called:     cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better     against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a     related partially matched (haploidentical) donor. As part of the treatment for their blood     cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances     of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed     to prevent GVHD and facilitate acceptance of the graft.   "
20424|NCT03018210|"     The proposed study will be a multi-centre, prospective, observational cohort to determine if     psychological well-being has an impact on the outcome of surgical repair for rotator cuff     tears.   "
20425|NCT03018197|"     The purpose of this pilot study is to examine the use of a personal health record to improve     medication adherence among patients with non-valvular atrial fibrillation taking dabigatran     for primary prevention of embolic stroke.   "
20426|NCT03018184|"     Patients with inherited muscle diseases can have several problems in their muscles, which can     be both structural and metabolic. All the different diseases can affect the contractility of     the muscles. The aim of the study is to investigate the relation between muscle strength and     contractile cross sectional area (CCSA) in the thigh and calf in patients affected by     inherited muscle diseases.   "
20427|NCT03018171|"     The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in     combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor     performance and on maternal fetal well-being.   "
20428|NCT03018158|"     The objective of this study was to compare level of artifact while tongue at rest and in     motion of dentulous subjects.   "
20429|NCT03018145|"     To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car     for reducing preoperative children's anxiety.   "
20430|NCT03018132|"     This study is designed to comprehensively investigate the anti-inflammatory role of vitamin D     in reproductive aged women, and its association with preeclampsia and depression. Findings     will have substantial impact providing new information implicated in the development of     preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive     fluid, and kidney stress) and postpartum depression (after birth).      Additionally, the study is designed to understand how early mental health screening and     evaluation can help pregnant women reduce their risk of developing postpartum depression.     Testing the acceptability and effectiveness of this mental health screening, education and     referral program at Cedars-Sinai Medical Center will provide valuable patient centered     qualitative and quantitative data that can be used in future services planning.      The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.   "
20431|NCT03018119|"     The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage     consensus bundle to provide every United States birthing facility consistent, validated     practice guidelines. To facilitate implementation of each element of this bundle at the     participants large tertiary center, the investigators utilized the Delphi method to identify     deficiencies, perceived barriers to implementation, and multidisciplinary consensus on     changes with high feasibility and impact on patient care.   "
20432|NCT03018106|"     Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing     postmenopausal female population, and the most common symptom is dyspareunia. Vaginal     estrogen is the most common treatment for VVA, but it only marginally improves overall sexual     function, and many women and clinicians avoid using it because of the risks of exogenous     estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor     modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown     superb improvements in overall sexual health. 104 women will be randomized to receive 12     weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated     estrogens, which is placed vaginally twice per week. The improvements in sexual health and     VVA symptom severity will be compared in each group. This study will help determine if     ospemifene is a better treatment medication than conjugated estrogens.   "
20433|NCT03018093|"     The trial is a single arm, single-center, non-randomized phase I clinical trial which is     designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with     relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)   "
20434|NCT03018080|"     The primary objective of this study is to assess the safety and feasibility of the following     two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by     paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus     pembrolizumab. The primary safety objective is to evaluate the overall grade 3 or 4     treatment-related adverse event rate for each cohort and compare them to relevant historical     controls.   "
20435|NCT03018067|"     This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action,     safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are     randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g     qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).   "
20436|NCT03018054|"     This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the     efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate     active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and     Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg),     E6007 60 mg or placebo.   "
20439|NCT03018015|"     The present study will be conducted in order to assess bioequivalence of the Test product     (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated     tablet), an approved market product in the European Union. Testing for bioequivalence will be     performed considering AUC0-tlast and Cmax obtained after oral single dose fasted     administration of ibuprofen.      In addition to the conventional immediate release tablet used as Reference 1, a soft capsule     formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example     for a product with a very fast absorption rate.      All 3 immediate release preparations contain 400 mg ibuprofen.   "
20440|NCT03018002|"     The purpose of this study is to evaluate the comparative effectiveness of a congregation,     clinic and integrated case management-based intervention for sustainable testing and     retention on linkage to care, engagement, retention and viral load suppression of women and     children infected with HIV.   "
20441|NCT03017989|"     Endometriosis is a common disease for which the current gold standard for diagnosis is a     diagnostic laparoscopy with histologic confirmation. However, during the diagnostic     laparoscopy endometriotic lesions are hard to identify due to the many appearances of     endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence     imaging will provide real time image enhancement for the detection of endometriotic lesions     by using the different vasculature in the endometriotic lesions. This hypothesis will be     tested in a prospective study with 15 patients scheduled for an elective diagnostic     laparoscopy for suspected endometriosis.   "
20442|NCT03017976|"     This study aims to assess the influence of exposure to swimming pool environment on     respiratory symptoms and diseases, and on cancer outcomes among swimmers and swimming pool     attendants.   "
20443|NCT03017963|"     The purpose of this trial is to evaluate the safety and maximum tolerable dose (MTD) of     sodium thiosulfate in patients presenting with an acute coronary syndrome and treated with     primary percutaneous coronary intervention (PPCI) via radial approach in adjunction to     standard treatment.   "
20444|NCT03017950|"     The purpose of the study is examining and comparing the pharmacokinetic drug interaction and     safety of both single administration and combination administration of CKD-330 and D086 to     healthy male subjects   "
20445|NCT03017937|"     Clinical trials have suggested that this device is effective in mitigating changes in brain     structure and function in athlete populations. The purpose of the current study is to measure     the response of the jugular vein to various pressures applied by a generic compression device     across various ages and gender. The relative jugular vein response will be measured using     ultrasound.   "
20446|NCT03017924|"     The purpose of the study is to monitor changes in brain structure and function between the     pre-training and post-training, in a population of tactical team members wearing the Device     and compared to a similar population not wearing the device. Secondly, the purpose is to     determine the protection of the device relative to amount and magnitude of sustained head     impacts.   "
20447|NCT03017911|"     This is a prospective monocentric study of PICC Line complications use in 5 medical and one     surgical units of Brest Medical University Hospital.      To evaluate the incidence of the following complications: infections, thromboses, mechanical     and hemorrhagic, at month 3 post-intervention.      Also evaluating:        -  the management of these PICC Line related complications,        -  risk factors for such complications,        -  and the mortality-related outcomes.   "
20448|NCT03017898|"     The purpose of this study is to determine whether treatment with laser coagulation is an     effective and safe treatment option for patients with anal fistula   "
20449|NCT03017885|"     This active surveillance will include all NSCLC patients treated with nintedanib per the     inclusion/exclusion criteria at approximately 20 selected centers until it is confirmed that     100 patients treated with nintedanib are included and that baseline characteristics of 100     additional patients (or as many patients as in the nintedanib group if <100) planned to be     treated with single agent docetaxel are collected from the same centres during the same time     frame, or until a maximum of two years, whichever occurs first   "
20452|NCT03017846|"     Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment     option. Treatment is often available in private practice offices, where a prescribing     physician may offer a non-FDA approved treatment on an individualized basis. The situation is     different in many hospital and academic settings, such as our own for example, where the     formulary is defined through a FDA-approved indication. The absence of an indication     precludes its addition to many hospital formularies, thus limiting the options available to a     prescribing physician and denying patient access to a treatment offered in the private     practice setting. An indication and formulary status require controlled clinical trials on     the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this     commercially-viable cantharidin formulation has a comparable safety and efficacy profile as     formulations previously studied under conditions which most closely match the what has been     historically done in the clinic.   "
20453|NCT03017833|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of TAK-228 and metformin that can be given to patients with advanced cancer. The     safety of the drug combination will also be studied.   "
20614|NCT03015727|"     In this study, the investigators aim to compare the progression-free survival (PFS) and side     effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally     advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete     response or partial response) after neoadjuvant chemotherapy (NACT).   "
20454|NCT03017820|"     This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis     virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS])     in treating patients with multiple myeloma, acute myeloid leukemia, or T-cell lymphoma that     has come back or does not respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has     been changed in a certain way, may be able to kill cancer cells without damaging normal     cells.   "
20455|NCT03017807|"     A single-central,open-label,safety,pharmacokinetics,phase I study. Biological:Recombinant     Anti-EGFr Antibody Two dose levels: Low-dose level patients received initial dose 100 mg/m2     and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable     toxicity or death or withdraw informed consent.High-dose level patients received cetuximab     initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance     to the disease progression or unacceptable toxicity or death or withdraw informed consent.   "
20456|NCT03017794|"     This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A     (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT)     is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is     measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a     definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time     points. The study will analyze the followings: 1. Change in CgA level at various pre-defined     post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA     change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA     change and treatment outcome.   "
20457|NCT03017781|"     The primary purpose of this study is to compare, over 24 months, the time spent with     clinically significant mood symptoms (ie, mania, depression), as measured by the Longitudinal     Interval Follow-Up Evaluation (LIFE) and the Psychiatric Status Rating Scale (PSR), in     offspring of bipolar parents with and without at least mild impairment in psychosocial     functioning.   "
20458|NCT03017768|"     Esophageal hypersensitivity is considered an important pathophysiological mechanism in     patients suffering form non-erosive gastro-esophageal reflux disease. Serotonin (5-HT) is     predominantly found in the central nervous system and in the gastro-intestinal (GI) tract.     5-HT plays a major role in the regulation of GI secretion, motility and sensitivity, and has     been associated with emotion regulation. Acute tryptophan depletion (ATD) temporarily reduces     the availability of tryptophan (TRP), thereby decreasing central and peripheral 5-HT     synthesis. From previous studies, ATD is known to affect GI physiology and enhance visceral     pain perception in the colon. The aim of the study was to investigate the effect of ATD on     esophageal sensitivity in healthy volunteers (HV).      Esophageal multimodal sensitivity was assessed after intragastric infusion of an amino-acid     mixture (AA-mix) containing 15 AAs with TRP (control condition) or without TRP (ATD     condition). After an incubation period of 5 hours, a probe with a polyurethane bag was     positioned in the distal esophagus. Thermal (recirculating a heated saline solution through     the bag), mechanical (increasing bag volume), electrical (2 stimulation electrodes) and     chemical sensitivity (modified Bernstein) were tested and at 3 time points blood samples were     collected for biochemical analysis. General mood was assessed by the Positive and Negative     Affect Schedule (PANAS) and the State-Trait Anxiety Inventory (STAI) questionnaires.   "
20459|NCT03017755|"     This is a survey to help understand the influences related to the decision for Adolescent     Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then     plans to create a decision aid to help families when making a decision about the treatment     choice being presented to them.   "
20460|NCT03017729|"     The purpose of this study is to assess the longitudinal attainment of subject centred and     functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after     abobotulinumtoxinA injection (including following repeated injection cycles where they occur)     alongside spasticity management used in real life settings over a period of 18 months (and a     maximum of six injection cycles).   "
20476|NCT03017521|"     The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog     (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently     aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral     allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent     anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose     to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with     advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of     K-BASKET trial.   "
20477|NCT03017508|"     The goal of the current proposal is to examine if sublingual riluzole can reduce anxiety in     people with social anxiety disorder during a public speaking task.   "
20704|NCT03014557|"     This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial     appendage closure technology in a Chinese population.   "
20461|NCT03017716|"     Articular involvement is the most frequent extra-intestinal manifestation of inflammatory     bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial     involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing     spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis,     dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall     pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset,     improves after exercise but not with rest, and is associated with morning stiffness. Up to     now, several criteria sets have been proposed to define IBP. Studies conducted in various     populations have confirmed a high sensitivity and specificity for the Berlin criteria. Celiac     disease (CD) is an autoimmune systemic disease having among its clinical manifestations     frequent symptoms common to rheumatologic diseases. Recently, it has been reported that a     consistent percentage of the general population consider themselves to be suffering from     problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat     allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS) or     Non-celic Wheat Sensitivity (NCWS). The clinical picture of NCWS is characterized by combined     gastrointestinal and extra-intestinal or systemic manifestations. Many patients affected with     CD and NCWS complain of IBP-like symptoms, which generally improve, together with the other     clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims     of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly     assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a     period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.   "
20462|NCT03017703|"     The importance of Aldosterone for endothelial function and Insulin resistance observed within     patients with type 2 diabetes   "
20463|NCT03017690|"     An observational time and motion study in a clinical oncology setting is utilized in order to     measure and compare product attributes and overall product efficiency between lanreotide and     octreotide LAR.   "
20464|NCT03017677|"     In this study the investigators is aimed to establish the MPS screening algorithm for high     risk patients who had medical history of previous surgical repair or presence of inguinal     and/or umbilical hernia with combination of any ENT related surgery or examination in Taiwan.   "
20465|NCT03017664|"     This quality improvement project will include a practice change based on national guidelines     for the nutritional management of PICU patients.   "
20466|NCT03017651|"     This protocol will determine the pK profile of two different omega-3 fatty acid supplements     on plasma EPA and DHA levels.   "
20615|NCT03015714|"     Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in     Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation     treatment.   "
20467|NCT03017638|"     Pain after abdominal surgery can be extensive. Pain control is an important component of     patient comfort and participation in rehabilitation. Multimodal analgesia methods have shown     to reduce postoperative pain, and have been addressed to be a crucial part of the Enhanced     Recovery after Surgery (ERAS) protocols.      Quadratus lumborum block (QLB) is a posterior abdominal wall block which analgesic efficacy     has been shown for abdominal surgeries, and also for different laparoscopic procedures, such     as ovarian surgery.      The aim of this study is to assess QLB's analgesic efficacy for laparoscopic colectomy     surgeries, using serial pain score assessments and overall opioid consumption; its effect on     patient satisfaction; and its effect on the development of postoperative respiratory     complications. This study is a prospective clinical trial assessing the effect of application     of QLB as a regional analgesic technique for primary laparoscopic colectomy, in comparison to     a historical retrospective cohort.   "
20468|NCT03017625|"     Chronic obstructive pulmonary disease (COPD) is known for development of severe     cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD     (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets     contribute to acute cardiovascular events and atherosclerosis. When platelets are activated,     they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early     process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD     is scarcely studied. This study aims to address this gap by investigating platelet function     and coagulation in patients with AE-COPD and after convalescence.   "
20469|NCT03017612|"     The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near     Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and     intermediate vision. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of a     hydrogel material, implanted under a lasik flap. Subjects must require reading add from +1.50     D to +2.50 D. Subjects must have a preoperative manifest refraction spherical equivalent of     -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop Near Vision     Inlay will be implanted in the non-dominant eye.   "
20470|NCT03017599|"     To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle     for EUS-guided fine needle biopsy in pancreatic solid lesions.   "
20471|NCT03017586|"     The purpose of this study is to evaluate the safety and effectiveness of deep brain     stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for     primary dystonia.   "
20472|NCT03017573|"     SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at     different time points in ovarian, triple negative breast and head and neck cancer patients.     This study will allowed to identify new molecular and/or immunological biomarkers associated     with clinical and biological features of the tumors. All patients will receive standard     treatment according to the stage of the diseases and usual procédures.   "
20473|NCT03017560|"     The primary purpose of this study is to test the effects of a targeted, computerized     cognitive training program on verbal memory in older women who have undergone chemotherapy     treatment for early-stage breast cancer. As measured by neuropsychological assessment, this     treatment will result in improved verbal memory. Secondarily, processing speed and naming     abilities are expected to improve. Enhanced self-perception of cognitive ability is also     expected.   "
20474|NCT03017547|"     Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14     (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation     will be for a total of 28 days.   "
20475|NCT03017534|"     The mechanism responsible for improvement following manual physical therapy techniques is     unknown. Previous studies have indicated both biomechanical and neurophysiologic effects     which may be responsible for clinical changes observed. Yet, other studies report clinical     changes following sham interventions. Through a mixed-methods design, this study aims to gain     more understanding of the social and contextual factors that may be related to the     improvement often observed following manual therapy techniques.   "
20479|NCT03017482|"     The purpose of this project is to track initiation and the first year of clinical use of the     newly FDA approved 670G closed loop insulin delivery system by patients who have requested     this system. Our goal is to evaluate our clinical approach to starting this newly approved     system. Since the investigators are only following patients who have already decided to start     the 670G, the investigator does not assign specific interventions to the subjects of the     study; thus this is a Observational study.   "
20490|NCT03017339|"     The purpose of this study is to investigate the effects of a functional exercise program     associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of     life of individuals with fibromyalgia. Half of participants will receive functional exercise     and LLLT, while the other half will receive functional exercise and placebo LLLT.   "
20491|NCT03017326|"     The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and     Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment     of children diagnosed with HB.      Children with HCC will be included as a separate cohort.   "
20492|NCT03017313|"     The purpose of the protocol, is to determine the percentage of patients for whom the initial     LHRH prescription has been renewed   "
20480|NCT03017469|"     Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives,     which can lead to adverse personal and professional outcomes. While workplace stress cannot     be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease     fatigue. Organizational employee health, wellness, and assistance programs are all     intentioned to provide this type of support; however, nurses often lack awareness of options     and opportunities, and access can be a challenge. The purpose of the proposed study is to     assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance     resilience and promote awareness of organizational resources for health, wellness, and     employee assistance. We will evaluate the impact of participation in ARISE on resilience and     other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight     Organization designated by the Registered Nurses Association of Ontario (RNAO), this project     will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to     Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse     Fatigue in Health Care.   "
20481|NCT03017456|"     Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate     cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with     the goal of identifying and tracking unmet supportive care needs of patients with localized     PC and responding to these needs through survivorship care. The current randomized control     trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate     Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an     appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT     to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC)     on patient activation (primary outcome) and access to services, self-Management support,     satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a     multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS)     will be used to electronically populate the survivorship care plans. Overall, this proposal     represents initial steps in uniting the country in sharing programmatic resources, data,     expertise, and enthusiasm to transform survivorship care for men with PC and their families.   "
20482|NCT03017443|"     The objective of this study was to determine changes in body weight and related outcomes     achievable over a 16-week period in response to three different commercially available weight     loss programs (Nutrisystem) providing pre-packed, portion controlled foods and beverages,     each compared to a self-directed diet, in apparently healthy overweight and obese men and     women.   "
20483|NCT03017430|"     It is a single blind randomized symptom triggered study to assess efficacy and safety of     pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs.     clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.   "
20484|NCT03017417|"     The proposed study will assess the feasibility of an exercise and dietary intervention in men     with castrate resistant prostate cancer with secondary outcomes assessing improvements in     physical functioning, fatigue, quality of life, and body composition.The study will have 2     arms, with one set of participants randomized to resistance exercise training intervention     plus dietary advice and the other arm will be standard of care plus exercise advice.   "
20485|NCT03017404|"     To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection     combination with cyclophosphamide and sequential treatment of docetaxel for patients with     locally advanced breast cancer   "
20486|NCT03017391|"     Nausea and vomiting are frequently occurring problems in the palliative phase of patients     with cancer. Between 20-50% of them regularly suffer from nausea, retching or vomiting. Often     the cause of nausea and vomiting is multifactorial and symptomatic treatment is necessary.      Potential drugs for symptomatic anti-nausea therapy are metoclopramide, serotonin     antagonists, the combination of both and dexamethasone as rescue medication in case of     failure. There is no data that depicts which strategy is the best. This study will be     conducted to unravel which treatment algorithm is most successful.   "
20487|NCT03017378|"     The study is a single centre, phase I, open, randomized, by intranasal and sublingual     application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21)     TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.   "
20488|NCT03017365|"     It is well documented that both balance and resistance training have the potential to     mitigate intrinsic fall risk factors in older adults. Recently, it was shown that a     simultaneously executed balance and resistance training, namely resistance training on uneven     surfaces is an eligible, effective and safe alternative training program to mitigate     intrinsic fall risk factors in older adults. However, knowledge about the effects of specific     adductor and abductor training has advantages over traditional resistance training and     resistance training on unstable surfaces regarding forward propulsion. Further, the effects     of different kinds of resistance training on cognition, especially embodiment is     investigated.   "
20606|NCT03015831|"     The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the     incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test     0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.   "
20489|NCT03017352|"     Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of     endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic     inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting     plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The     long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0%     as the treatment goal.      Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain,     and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.      The abovementioned problems associated with insulin treatment in T1D can also be seen in     insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of     insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in     reducing the weight gain and insulin dose in insulin-treated patients with T2D without     exacerbating the risk of hypoglycaemia.      Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators     intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin     therapy for patients with T1D.      The investigators hypothesise that the add-on of exenatide to insulin therapy in patients     with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve     glycaemic control without increasing the risk of hypoglycaemia.   "
20616|NCT03015701|"     To compare daily oral mifepristone vs placebo with respect to time to treatment failure in     patients with unresectable meningioma.   "
20493|NCT03017300|"     Inspiratory muscle training（IMT）was an rehabilitation therapy for stable patients with     chronic obstructive pulmonary disease(COPD). However, its therapeutic effect remains     undefined due to unclear of diaphragmatic mobilization during IMT. Diaphragmatic mobilization     represented by transdiaphragmatic pressure（Pdi）and neural respiratory drive expressed as     corrective root-mean-square(RMS) of diaphragmatic electromyogram(EMGdi) provide vital     information to select the proper IMT device and loads in COPD, therefore make curative effect     of IMT clarity. Pdi and RMS of diaphragmatic electromyogram (RMSdi%) was respectively     measured and compared during inspiratory resistive training and threshold load training in     stable patients of COPD.   "
20494|NCT03017287|"     The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with     uncontrolled diabetes treated with MDI.   "
20495|NCT03017274|"     Recently it has been reported that a consistent percentage of the general population consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac     Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term     'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes     the symptoms in NCGS patients, and the investigators also showed that these patients had a     high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and     extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'     tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,     and anemia). Nowadays no data are available on the abdominal ultrasonographic features of     NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal     ultrasonographic features of NCWS patients in comparison with patients affected with celiac     disease.   "
20496|NCT03017261|"     The goal of this prospective, non‐randomized, multicenter clinical trial is to determine     whether robotic‐assisted total knee arthroplasty performed with TSolution One® System is safe     and effective for use as an alternative to the conventional manual techniques. Clinical and     radiographic outcomes for robotic‐assisted total knee arthroplasty performed with the     TSolution One® System will be collected preoperatively, intraoperatively, and postoperatively     up to a follow‐up period of 3 months. These outcomes will be compared to the ones reported in     the literature for conventional manual techniques.   "
20497|NCT03017248|"     This study aims to determine the efficacy and safety of low dose ketamine in association with     IV morphine in the management of acute moderate to severe pain in emergency department.      The investigators hypothesize that low dose ketamine will result in more effective pain     control than morphine alone and will not be associated with an increase in adverse events.   "
20498|NCT03017235|"     The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous     Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing     colonoscopy.   "
20499|NCT03017222|"     Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and     underwent laparoscopic surgeries under general anesthesia were assessed for eligibility.     Patients who developed PONV within the first 2 hours after anesthesia received intravenously,     in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were     then observed for 24 hours after drug administration. The incidence of nausea and vomiting,     severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24     hours after drug administration were evaluated. The primary endpoint was the rate of patients     exhibiting complete response, defined as no emesis and no further rescue antiemetic     medication for 24 hours after drug administration.   "
20500|NCT03017209|"     This study is a randomized controlled trial with a main goal to assess the effects of a     locally-prepared food for prevention of malnutrition and stunting, in comparison with     standard village practices and also a widely available aid food supplement in 8-12 villages     in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome     will be cognitive tests of executive function. Secondary outcomes will be changes in standard     anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living     in villages in rural Guinea-Bissau. This is a within-village randomization at the level of     the family, and all children will receive a dietary intervention.   "
20599|NCT03015922|"     This study will recruit patients currently receiving either lenalidomide or pomalidomide     whose disease is relapsing. This is a dose escalation study and the aim is to determine the     maximum tolerated dose (MTD) of REOLYSIN® that can be given in combination with lenalidomide     or pomalidomide. The study will also investigate the safety, side effects and effectiveness     of this treatment combination. Pomalidomide and lenalidomide will be evaluated separately as     two separate groups.   "
20501|NCT03017196|"     This study is designed to answer the following questions: Is the My Life, My Healthcare     Discussion Aid feasible for use in primary care? Does it positively impact patient and     healthcare teams' care experience and communication, while reducing patient treatment     burden?      Through implementation of the My Life, My Healthcare Discussion Aid for patients with chronic     conditions, the study team hypothesizes that it will be feasible to implement in routine     primary care practice and positively impact patient and healthcare teams experience of     chronic care, while reducing patient treatment burden.   "
20502|NCT03017183|"     Study participants will be selected from clinical routine patients with endobronchial     infiltration of a central lung cancer and indication for bronchoscopic sampling.      Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling     methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The     sequence of both sampling methods will be randomized in advance.      The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH.     The corresponding analysis results will be compared between sampling methods.      Assignment of a subject to a particular therapeutic strategy is not influenced by this     protocol. Medicinal products will be used according to current practice and marketing     authorisation.   "
20503|NCT03017170|"     A randomized, double-blind, placebo controlled study to evaluate the efficacy of dried     cranberry at 500 mg daily in women with overactive bladder for 6-months.   "
20504|NCT03017157|"     The study plans to investigate whether recovery of the heart function after acute anterior     myocardial infarction is dependent upon improvement in thyroid gland functioning.   "
20611|NCT03015766|"     Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent     years and yielded favorable results. However, the effect and safety of AAT for insomnia in     MHD population still lacks high quality evidence. A randomized controlled clinical trial is     planned to evaluate the effect and safety of AAT in MHD patients with insomnia.   "
20505|NCT03017144|"     Cardiac arrest is handled by cardiopulmonary resuscitation which is a time critical emergency     situation. The actions during resuscitation are lead by international guidelines.     Traditionally, the main focus of the training has been on medical knowledge and technical     skills (TS). Nowadays non-technical skills (NTS), such as communication, teamwork behaviour,     and leadership, are considered at least equally important.      The aim of this study is to evaluate both TS and NTS of the resuscitation team during     real-life resuscitation situations using a validated assessment tool. The correlation of TS     and NTS will be analyzed. Findings from this study may help to recognize the possible     weaknesses and issues which could be improved by training. Hypothesis is that that TS are     probably in a high level, but some improvement points of NTS are ought to be known better.     Investigators also hypothesis that the good NTS performance in resuscitation is accompanied     by good TS performance.   "
20506|NCT03017131|"     This phase I trial studies the side effects of genetically modified T cells and decitabine in     treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come     back or has not responded to previous treatments. White blood cells called T cells are     collected via a process called leukapheresis, genetically modified to recognize and attack     tumor cells, then given back to the patient. Decitabine may induce and increase the amount of     the target protein NY-ESO-1 available on the surface of tumor cells. Giving genetically     modified T cells and decitabine may kill more tumor cells.   "
20507|NCT03017118|"     The aim of this study is to assess whether the use of a commercially available nutraceutical,     turmeric, is an effective option to manage pain and stiffness in patients with basal joint     arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric     on basal joint arthritis.   "
20508|NCT03017105|"     Proximal humerus fractures (break of the top part of the upper arm bone) are common in older     people with poorer bone quality. Often patients do not undergo surgery for these fractures:     the bone fragments may be in an acceptable enough position to be able to heal naturally, or     the patient may not be well enough medically to undergo an operation. These patients need to     wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly     when they are unable to be used. This research project will look at whether strength-training     the opposite/uninjured limb, known as cross education, has any effect on preserving the     function of the injured/fractured limb. Participants will be randomised into two groups using     minimisation, that is to say the groups will have balanced numbers in terms of exact pattern     of fracture and gender. One group will receive traditional rehabilitation exercises and     treatment by the physiotherapist for their injured limb; the other group will receive the     same but in addition will also undergo a strength-training exercise programme for their     uninjured limb. Only qualified physiotherapists with experience of treating this patient     cohort will be involved. Sessions in the physiotherapy department will last up to 30 minutes     each and will comprise of: patient review, exercise progression, and advice giving/question     answering; home exercise programmes will be expected to be completed 2-3 times daily and last     up to 30 minutes each; number of sessions will be agreed between the participant and treating     physiotherapist with treating ending once an agreed, acceptable level of function has been     achieved. The Oxford Shoulder Score patient-reported outcome measure will be completed by the     participant at 6 and 12 weeks and the European Quality of Life (EuroQoL)-5D-5L at 12 weeks     after commencement of treatment.   "
20509|NCT03017092|"     Pilot study to test feasibility of delivering a motivational smoking cessation intervention     to low income smokers via a computer tablet.   "
20510|NCT03017079|"     Malnutrition and underfeeding are major challenges in caring for critically ill patients.     Continuous feeding were thought to be better tolerated by patients with the limited     absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube     clogging and required the patient to be attached to an infusion pump for significant periods     of time. Intermittent infusion resembled more physiological feeding process, which allowed     greater patient mobility and might reach goal enteral calories earlier, and the latter were     considered to effectively decrease the length of stay (LOS)-in-hospital and mortality.     However, it also had some previous study found that intermittent infusion had more     complications, such as diarrhea, regurgitation than continuous. Some study found that it was     an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution     viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to     study whether receiving semi-solidification of nutrients could increase the percent     prescribed calories received by improving the feeding intolerance, and secondary goal was to     observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung     infection, 30-days mortality and the glycemic variability (GV).   "
20511|NCT03017066|"     The purpose of this study is to compare the gastric volume in pediatric patients who followed     preoperative fasting guideline using ultrasound.   "
20512|NCT03017053|"     Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate     management of the neck is therefore of paramount importance in the treatment of oral cancer.     However, there is still some controversy on the treatment of early maxillofacial     malignancies. Currently, investigators have no accurate uniform treatment standards,     including the National Comprehensive Cancer Network (NCCN) recommended between surgery and     radiotherapy options. Clinical evaluation indicated that lymph node-negative patients     eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with     true node-negative, preventive cervical lymph node dissection is obviously over-treatment,     and lower quality of life. Radiotherapy can avoid such surgery.   "
20513|NCT03017040|"     The investigators hypothesize that there is no relationship between in vivo kinematic     abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries     (SLIL)      The secondary null hypotheses are that: There are no kinematic differences between subjects     with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the     contralateral wrist without scapholunate ligament injury.      The investigators aim to answer to the below questions:        -  What are baseline validated outcomes for subjects with SLIL injury?        -  What are baseline physical measures (range of motion, Jamar Dynamometry)?   "
20514|NCT03017027|"     The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation     (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by     comparing responses between TDV and non-TDV control groups.   "
20515|NCT03017014|"     The primary objective of this study is to evaluate long-term effectiveness of adalimumab in     pediatric participants starting a treatment for Crohn's disease in real life conditions,     namely to describe the time to loss of clinical benefit in a time to event approach. Main     secondary objectives are to describe growth and pubertal development and to describe     long-term safety. The participants will be followed-up up to 10 years.   "
40806|NCT02751489|"     To determine the phototoxic potential of a topically applied article in human subjects   "
20516|NCT03017001|"     Omega-3 polyunsaturated fatty acids (w-3-PUFA) may have a potential role in enhance the     postoperative balance of host immunity and reduce the incidence of postoperative atrial     fibrillation (POAF). CHO drinks 2h before the induction of the anesthesia may reduce the     necessity of vasoactive drugs preoperatively. the aim of this study was to investigate the     effect of these two nutrients in patients undergoing CABG with cardiopulmonary bypass (CPB)     on morbidity at ICU, mainly POFA. This is a double-blind controlled randomized trial.   "
20517|NCT03016988|"     Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival.     This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and     Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy     and transplantation.   "
20518|NCT03016975|"     To establish the safety and effectiveness of the Edwards Cardioband System in patients with     functional mitral regurgitation (FMR).   "
20519|NCT03016962|"     The potential benefit of using the cap is that it helps in luminal orientation at bends by     keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients     with a history of abdominal surgery is considered to be difficult due to adhesion-related     bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in     patients with prior abdominal surgery. The investigators designed a randomized, controlled     trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal     surgery.   "
20520|NCT03016949|"     The study will evaluate the humoral immunogenicity in various schedule combinations of full     dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the     fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).   "
20521|NCT03016936|"     Multicentre international prospective cohort study designed to answer the question: In     patients undergoing elevated risk noncardiac surgery, are METs estimated by questionnaire     associated with perioperative major adverse cardiovascular events or cardiovascular     mortality? If so:        1. What is the optimal cut-off for METs estimated by questionnaire to predict perioperative          major adverse cardiovascular events or cardiovascular mortality?        2. How does the optimal cut-off compare with the currently guideline-endorsed 4-MET          cut-off?   "
20522|NCT03016923|"     The proposed pilot study seeks to explore the effectiveness of Functional Electrical     Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years)     with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary     outcome measures obtained pre- and post-intervention in a case series study design.   "
20523|NCT03016910|"     Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a     morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign     (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the     influence of microvascular dysfunction and additional risk factors on plaque morphology and     plaque burden in patients with diabetes mellitus.   "
20524|NCT03016897|"     ALS AT HOME is a single-center study of up to 250 participants being done to determine the     extent to which frequent sampling can improve the qualities of outcome measures collected at     home by study participants.   "
20525|NCT03016884|"     The reactivation of varicella zoster virus (VZV) (herpes zoster (HZ)) is of substantial     public health concern. Updated ACR recommendations for RA treatment suggest that RA patients     aged ≥ 50 years should be vaccinated before receiving biologic or tofacitinib therapy. The     Investigators therefore propose a prospective study to evaluate the safety, tolerability, and     immunogenicity of a zoster vaccine (Zostavax) in patients with RA, administered at least 2     weeks prior to initiation of anti-TNF biologic and tofacitinib therapy for RA.      This is a 6-week open-label prospective multi-center study evaluating the safety,     tolerability, and immunogenicity of Zostavax vaccine in the RA population prior to initiation     of biologic/tofacitinib therapy for RA. VZV-specific immune response to vaccine in RA     patients will be compared to healthy control subjects ≥ 50 years immunized with Zostavax.   "
20600|NCT03015909|"     The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks     subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human     growth hormone by reusable device.   "
20526|NCT03016871|"     This phase II trial studies the side effects of nivolumab and to see how well it works when     given together with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin     lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as     nivolumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in     chemotherapy, such as ifosfamide, carboplatin and etoposide, work in different ways to stop     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or     by stopping them from spreading. Giving nivolumab, ifosfamide, carboplatin and etoposide may     work better in treating patients with Hodgkin lymphoma.   "
20527|NCT03016858|"     With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology     for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely     applied in VATS. A multicenter randomized parallel controlled study was applied in this study     to assess the feasibility and safety of thoracoscopic bullectomy surgery under intravenous     anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.   "
20528|NCT03016845|"     Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking     resulting in large variation of achieved exposure and possible inadequate therapy. The     investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to     individualize and optimize therapy for ciprofloxacin and eventually improve outcome.      In a multi-centre, observational, open-label study the investigators aim to define : the     model for estimation of renal function that most accurately predicts ciprofloxacin clearance     in critically ill patients.   "
20529|NCT03016832|"     1. Name of Investigational Products Huangkui capsule.        2. Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical          Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)        3. Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment          of type II diabetes ACR.           Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary          protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and          improving Traditional Chinese medicine clinical efficacy        4. Trial Design Designed as a block randomized, double-blinded, parallel controlled,          multi-center clinical trial.   "
20530|NCT03016819|"     This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the     treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS),     and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In     participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the     participants will receive AL3818, one-third of the participants will receive IV dacarbazine.   "
20531|NCT03016806|"     This study is a single-center, treatment protocol with 4 possible preparative regimens,     designed to validate the process of umbilical cord blood stem cell transplantation at our     institution.   "
20532|NCT03016793|"     P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft     C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device     Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number     0—10      Radiographic outcome:      Outcome name Measurment Device Measurment unite Bone volume      (Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density      (Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would     purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying     than tricalcium phosphate alone in alveolar cleft grafting?   "
20533|NCT03016780|"     Ulcerative colitis is a common digestive system disease, the incidence is increasing in     recent years.It is reported that the occurrence and development of ulcerative colitis is     closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be     related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild     intestinal flora has been used for several disease，but the efficacy of ulcerative colitis by     fecal microbiota transplantation needs to be further explored.   "
20534|NCT03016767|"     Oral feeding in the neonatal period requires an accurate coordination between suction,     swallowing and breathing. In premature new-borns and, depending on their gestational age, the     coordinated work of those processes becomes jeopardised, being necessary to begin with an     artificial enteral feeding. This situation results in lengthen their stay at the hospital     until they are able to respond in a reliable way to their nutritional requirements orally,     maintaining an adequate daily weight gain and without endangering their cardiorespiratory     system.      This project is an experimental, prospective, blinded, randomized study, aimed to determine     whether the application of a manual oral stimulation protocol in premature infants,     hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral     full feeding, while improves quality of feeding and shortens hospitalization time.   "
20535|NCT03016754|"     This study is designed as a multi-center prospective observational study of newly diagnosed     Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF)     recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is     achieved. Although the study doesn't start until day 90, all eligible, consenting patients     will be entered into a registry at the start of wearable cardioverter defibrillator (WCD)     use. The pre-study registry will allow us to collect early (90 day) outcomes and data in     those patients who are likely to be eligible for the study at day 90, or are eligible, but     refuse the study at day 90.   "
20536|NCT03016741|"     This clinical trial studies cognitive function in men with prostate cancer treated with     androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The     investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes     in brain structure or activity related to treatment that may be related to changes in     cognitive function. The investigators are also looking for genetic variations that might make     patients more or less sensitive to cognitive changes during treatment for prostate cancer.   "
20624|NCT03015597|"     The purpose of this study is to see whether contingency management (CM) can be successfully     added as an adjunct treatment to standard stop smoking services in outpatients undergoing     treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for     opiate addiction will be stratified to a CM intervention for either smoking abstinence or     attendance at the clinic, whilst also receiving usual stop smoking services cessation     treatment. The intervention will run for five weeks and participants will be followed up six     months after the beginning of the study.   "
20537|NCT03016728|"     More adolescents and young adults are surviving cancer than ever before. Many endure negative     effects related to their cancer and its treatment, which reduces their quality of life and     functioning. Physical activity is one strategy that has been shown to promote quality of life     amongst cancer survivors. However, very little research has focused on adolescent and young     adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is     to explore the feasibility, safety, and potential benefits of a 12-week home-based physical     activity intervention in adolescent and young adult cancer survivors.   "
20538|NCT03016715|"     : Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA     leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong     painful thick soles on their feet, and current standard of care is supportive. This pilot     study will target the dominant mutant keratin proteins in the skin to ameliorate the severity     of EB simplex. The purpose is to improve the function of EB simplex feet with an application     of topical sirolimus, 2%. The investigators plan on inhibiting the mTOR pathway to down     regulate the translation of defective keratin proteins and work through anti proliferative     pathways.   "
20539|NCT03016702|"     The purpose of this study is to test whether two new cognitive stress tests may help     distinguish between people at lower or higher genetic risk of Alzheimer's Disease. The     investigators are trying to understand how these cognitive stress tests work in people who     have not been diagnosed with Alzheimer's Disease and are not exhibiting symptoms of     Alzheimer's Disease. Study subjects will undergo testing of memory and executive function     during functional magnetic resonance image (fMRI) of the brain and also during a walking     test.   "
20540|NCT03016689|"     While the maternal-newborn exchange of airway microbiota is well-documented, no studies have     examined within-subject relationships among the mouth, sinuses, nasopharynx and lungs and the     relative abundance of bacterial taxa at those sites. Recent evidence suggests the oral cavity     may serve as a reservoir for pathogens that translocate to non-oral locations;     oral-associated microbes infect most other body sites as evidence by 16S sequencing.      By using a combination of oral and throat swabs, together with nasal suction of mucus     samples, the investigators will use metagenomic sequencing to characterize the composition of     bacterial communities at each anatomical site. Beginning at birth, a time-series of swabs     will be collected from each subject, and monitor changes in the development of microbiota     over time. By doing so, our studies will illuminate airway trafficking of both beneficial and     pathogenic microbes and may represent an essential pathophysiological step towards shifting     the balance between airway health and disease.   "
20541|NCT03016676|"     This study will give a new insight to the physiotherapy fraternity in the effects of spinal     manipulation in as clinical practice, as well as the patient's community in quick     re-establishment of functional ability, pain decrease, and improvement of quality of life for     economic reasons. In this high opinion, application of short-term intensive spinal     manipulation for non specific chronic low back pain treatment is desirable.   "
20542|NCT03016663|"     Prospective observational study to evaluate effects on washing to improve viability of fat     grafts in breast lipofilling.   "
20543|NCT03016650|"     The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in     patients undergoing percutaneous nephrolithotomy (PCNL).   "
20544|NCT03016637|"     This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may     improve the diagnostic yield during biopsies of pancreatic lesions   "
20545|NCT03016624|"     To compare coronary healing after optical coherence tomography guided versus conventionally     angiography guided percutaneous coronary intervention with the Magmaris bioresorbable     scaffold.   "
20546|NCT03016611|"     To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial     Infarction (STEMI) patients on platelet reactivity.   "
20547|NCT03016598|"     This study will investigate the effects of intranasal administration of oxytocin, a social     neuropeptide, on reducing cocaine use, enhancing therapeutic engagement, and susceptibility     to stress-induced relapse in Veterans with cocaine use disorder and enrolled in methadone     maintenance therapy (MMT) program for co-occurring opioid use disorder (OUD).   "
20548|NCT03016585|"     Fibromyalgia (FM) is an idiopathic disease affecting approximately 3% of the world     population, primarily diagnosed in middle-aged women. Although FM is mainly characterized by     chronic pain and fatigue, reduced muscular strength and flexibility are common symptoms     associated with the presentation of the disorder. Interestingly, the etiology and underlying     mechanism of FM are not completely understood, but previous findings suggest that autonomic     dysfunction may explain some of the FM symptoms.      Compared to age-matched healthy individuals, patients with FM have an attenuated autonomic     function which is associated with a reduction in vagal tone and increase in sympathetic     activity. Therefore, autonomic function is a worthwhile target intervention in individuals     with FM. Although traditional exercise ( both aerobic and resistance) has been shown to     effectively improve HRV parameters and FM symptoms, most FM patients display a decline in     adherence to traditional exercise and continue to experience considerable pain and fatigue     years after the original diagnosis ultimately requiring medication to control their     symptoms.Thus, new approaches are needed to improve autonomic function and clinical symptoms     in patients with FM, which will ultimately improve their physical and emotional functioning     leading to a better quality of life.      Tai Chi (TC) is a form of ancient Chinese martial art which integrates slow movements,     controlled breathing and mental concentration. TC training is safe for special populations     and has previously shown to decrease pain, fatigue as well as other FM related     symptoms.However, the potential role of TC training on autonomic function is largely     unexplored.      The investigators hypothesis is that 12 weeks of TC training would improve our primary     outcome of autonomic function through improvements in sympathovagal balance, and the     secondary outcomes measures of FM symptoms (pain, fatigue and sleep quality), strength and     flexibility.   "
20549|NCT03016572|"     This research study is designed to answer specific questions about new ways to provide     services for youth at-risk of suicide.   "
20550|NCT03016559|"     The purpose of this study are to compare angles of hip joint between before and after     releasing quadratus lumborum muscle.   "
20601|NCT03015896|"     This I/II trial studies the side effects and best dose of lenalidomide when given together     with nivolumab and to see how well they work in treating patients with non-Hodgkin or Hodgkin     lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as     nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in     chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving nivolumab and lenalidomide may work better in treating patients with     non-Hodgkin or Hodgkin lymphoma.   "
20602|NCT03015883|"     A unique approach for cancer treatment employing intratumoral diffusing alpha radiation     emitter device.   "
20551|NCT03016546|"     Depression is a common perinatal complication that can have a profound, adverse effect on     maternal and child health outcomes. The proposed study will directly address this important,     but understudied area by evaluating the feasibility and preliminary effect of an innovative,     integrated intervention approach, BEST-maCARE [Better Education, Support, Treatment for     maternal Capacity, Adherence, REtention in care]. The multi-component intervention is guided     by a model drawn from self-regulation and bioecological systems theory. Proactive counseling     personalized to the patient and socio-cultural context is delivered by trained clinic     personnel (e.g., counselors) to build problem solving and coping skills and linkages to     mental health, HIV treatment and ancillary services. The theory-guided intervention approach     has been found effective in improving the health behavior and outcomes (e.g., virologic) of     vulnerable, marginalized HIV+ women and men in rural and urban settings in the US     (AI38858-ACTG 731; R01NR05108). Although the investigators formative research suggests that     it is well suited for the target population, its usefulness in addressing significant gaps in     care among perinatal women.      l women with co-morbid conditions in a different socio-cultural, limited resource setting has     not been studied.   "
20552|NCT03016533|"     Dolutegravir (DTG) is a potent inhibitor of the human immunodeficiency virus type 1 (HIV-1)     integrase that has been developed for the treatment of HIV. This is a phase 3b (PH3b),     non-randomized, open-label, multi-center, treatment rollover study. The primary objective of     this pediatric interventional study is to provide continued access to DTG for eligible     participants who previously participated in the international maternal pediatric adolescent     acquired immunodeficiency syndrome [AIDS] clinical trials (IMPAACT) P1093 study (parent     study) and who cannot locally access DTG in the public sector. The P1093 study was designed     to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral activity of DTG in     HIV-1 experienced adolescents and children as well as treatment-naive infants and toddlers.     Participants who have no evidence of virological failure (VF) and who have tolerated DTG in     the parent study without any significant toxicity leading to the permanent discontinuation of     this drug and withdrawal from the parent study will be considered for this open-label     continued access study. Participants will be receiving their age/weight appropriate dose of     DTG as defined in the parent study. The objective of this study will be supported through     evaluation of serious adverse events. The duration of participant accrual into the study will     extend until DTG receives local (by country) regulatory approval . Therefore, participants     enrolled into this study will be those who will benefit from treatment and will continue to     receive DTG until local (by country) regulatory approval and commercial or other availability     occurs from another source (e.g. government programs, aid programs, assistance programs,     etc.). Participants will be enrolled after all screening procedures have been completed. In     most cases, the Screening visit will overlap with the participant's penultimate visit on the     parent study (at Week 180 of P1093). Participants who meet all entry criteria may enroll and     will be seen in the clinic every 12 weeks for a safety evaluation and to receive DTG. It is     estimated that no more than 120 participants will be enrolled in this study.   "
20553|NCT03016520|"     The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164     in healthy male volunteers.   "
20554|NCT03016507|"     The objective of this study is to evaluate the IOP variation before and 30 days after     performing phacoemulsification through pneumatic tonometry, in addition to evaluating the     factors possibly related to this variation.   "
20555|NCT03016494|"     The purpose of this study is to compare the safety and pharmacokinetics between     co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects   "
20612|NCT03015753|"     The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on     the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility,     acceptability, compliance and maintenance of Tai Chi exercise among this population.   "
20556|NCT03016481|"     This is a 3-year comparative effectiveness study funded by the Patient Centered Outcomes     Research Institute (PCORI) and will test an adapted priority-based patient navigation versus     care as usual among 300 survivors of intimate partner violence (IPV) recruited from, and/or     referred from, University of Rochester Medical Center providers. The goal is to improve     patient safety, depression, and health function over the course of 12 months. In the     Community Health Worker -Personalized Support for Progress (CHW-PSP) arm, created and tested     in our first UR PCORI grant, in addition to meeting with a social worker, patients will work     with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed     over the course of the next 6 months to navigate services and overcome barriers. In addition,     patients will receive referrals to other professionals based on their prioritization and meet     with the CHW at the time and place of their choice. Patients in the Care as Usual- Social     Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for     intake and referrals, does a needs assessment, and offers safety planning in referral.   "
20557|NCT03016468|"     This is a multicenter, single-arm trial to evaluate the safety of the transition from     Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary     Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10     clinical trial centers. The treatment phase of the study will last approximately 16 weeks.   "
20558|NCT03016455|"     This study aims to better characterise B cell phenotype and functional abnormalities in     kidney transplant patients producing donor specific antibody (DSA) and in those with chronic     antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The     functional analysis will help to better understand B cell-dependant mechanisms implied in T     cell proliferation and better target future treatments.   "
20559|NCT03016442|"     Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the     induction of labor   "
20560|NCT03016429|"     This protocol outlines a prospective study evaluating safety and clinical outcomes of     magnetic resonance imaging (MRI) examinations performed on patients with cardiac implantable     electrical devices (CIEDs) including pacemakers (PMs) and implantable     cardioverter-defibrillators (ICDs). This prospective study aims to improve the evidence base     regarding this common clinical scenario. Specifically, the investigators aim to address     whether results of MRI in PM/ICD patients affect physician decision making related to     clinical management strategy and planning treatment interventions. Further, this study will     evaluate whether the results of MRI in these patients affects patient outcomes related to     survival and adverse events during or after MRI scanning.   "
20625|NCT03015584|"     This study will use systems biology techniques, especially RNA-seq, to understand cognitive     impairment after sepsis requiring an intensive care unit (ICU) admission.   "
20626|NCT03015571|"     The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely     used during esophagus inspection at diagnostic gastroscopy.   "
21936|NCT02998476|"     The purpose of this study is to assess the safety and efficacy of INCB050465 in subjects with     relapsed or refractory diffuse large B-cell lymphoma.   "
20561|NCT03016416|"     Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation     outcomes and to increase in mortality. The severity of the autonomic dysfunction can be     measured in many ways, but the most common way is assessment of the     sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that     the plasticity of the brain can influence the autonomic nerve system and that providing     appropriate stimuli encourages these changes. It was found that stimulation of rhythm,     stimulation of cognitive tasks and stimulation of activity, influence the autonomic nerve     system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive,     rhythm) may influence the autonomic nervous system and cause an increase in brain activity,     therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose     of this study is to examine the influence of stimulation of rhythm, stimulation of cognition,     stimulation of activity and combined stimulation, on the autonomic nerve system. This effect     will be tested by measuring heart rate variability in chronic stroke patients and in a     control group.   "
20562|NCT03016403|"     Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally     encounter significant disparities in accessing care for their mental health needs while     undergoing toxic treatments that provide considerable physical and emotional stress. Thus,     the investigators propose to adapt evidence-based strategies to a stepped-care intervention     model to address the mental health needs of under-served lung cancer (LC) and head and neck     cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g.,     mild, moderate, or severe symptoms of depression and anxiety).   "
20563|NCT03016390|"     Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of     patients with it are growing rapidly. Electromagnetic interference causing device malfunction     is not uncommon, Radiofrequency Identification system is among its plausible source. Patients     with CIEDs are at risk of exposure to this novel product in their daily living especially     automobile keyless access system. Only informal studies have been conducted and not be     published. Formal and systemic evaluation and tests are crucial.   "
20564|NCT03016377|"     This research study combines two different ways of fighting disease: antibodies and T cells.     Both antibodies and T cells have been used to treat patients with cancers. They both have     shown promise, but neither alone has been sufficient to cure most patients. This study is     designed to combine both T cells and antibodies in order to create a more effective     treatment. The treatment that is being researched is called autologous T lymphocyte chimeric     antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration.      In previous studies, it has been shown that a new gene can be put into T cells that will     increase their ability to recognize and kill cancer cells. The new gene that is put in the T     cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to     leukemia cells because they have a substance on the outside of the cells called CD19. For     this study, the anti-CD19 antibody has been changed so that instead of floating free in the     blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this     way it is called a chimeric receptor. These CD19 chimeric (combination) receptor-activated T     cells seem to kill some of the tumor, but they do not last very long in the body and so their     chances of fighting the cancer are unknown.      Preliminary results have shown that many subjects receiving this treatment have experienced     unwanted side effects including cytokine release syndrome. In this study, to help reduce     cytokine release syndrome symptoms, the ATLCAR.CD19 cells have a safety switch that when     active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the     safety switch are referred to as iC9-CAR19 cells. If the subject experiences moderate to     severe cytokine release syndrome as a result of being given iC9-CAR19 cells, then the subject     may take part in a sub-study where you will be given a second study drug, AP1903. AP1903     activates the iC9-CAR19 safety switch, reducing the number of the iC9-CAR19 cells in the     blood. The goal of the sub-study is to determine what dose of AP1903 can be given that     reduces the severity of the cytokine release syndrome to mild, but still allows the remaining     iC9-CAR19 cells to effectively fight the leukemia.      The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe     and tolerable and to determine an optimal dose of AP1903 to be given to subjects to alleviate     severe cytokine release syndrome.   "
20565|NCT03016364|"     The purpose of this trial is to determine whether Application (APP) would help clinical     doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced     patients with cancer pain.   "
20613|NCT03015740|"     The goal of this clinical research study is to find the highest tolerable or recommended dose     of MGCD5 that can be given with nivolumab to patients with kidney cancer. Researchers also     want to learn if this dose can help to control the disease. The safety of this drug     combination will also be studied.   "
20566|NCT03016351|"     After the participant meets all inclusion and exclusion criteria, they will be randomized     equally to either the Resistance Training group (RT) or Aerobic Training group (AT). Both     groups will participate in an 8 week initial control period, followed by 8 weeks of     supervised exercise training, followed by 8 weeks of deconditioning. All participants will     undergo the same assessments and procedures one time prior to the initial 8 week control     period, and at each of the three periods. Assessments include: blood draws; arterial     stiffness testing; ultrasounds of the brachial artery to measure flow-mediated dilation     (FMD); gluteal adipose tissue biopsies; exercise testing to determine VO2 max; body     composition analysis via DEXA scans; ambulatory blood pressure measurement; diet analysis via     food journals; medical history questionnaires; urine analysis for pregnancy; and activity     monitoring via accelerometer. Total participation will be 24-26 weeks.   "
20567|NCT03016338|"     This is a phase 2 study of investigational drug niraparib in patients with advanced/recurrent     endometrial cancer. The purpose of this study is to determine whether blocking a protein     called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in     patients with recurrent endometrial cancer, as well as to explore the possible impact of     phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN gene) on blocking     PARP with niraparib.   "
20569|NCT03016312|"     This Phase III, multicenter, randomized, open-label study will evaluate the safety and     efficacy of atezolizumab in combination with enzalutamide compared with enzalutamide alone in     participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone)     and failure of, ineligibility for, or refusal of a taxane regimen. Participants will receive     treatment until investigator-assessed confirmed radiographic disease progression per Prostate     Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.   "
20603|NCT03015870|"     Many detrimental effects of aging have been identified in the human voice, most of which are     accepted as normal. However, age-related vocal deficits disrupt communication and decrease     quality of life in older adults and may be preventable and/or treatable through behavioral     interventions. The objective of this proposal is to determine the effectiveness of a     technology-assisted vocal exercise intervention on the vocal function and quality of life in     older adults. Forty older adults (65+) will be recruited and randomly assigned to either an     app or PDF-delivered vocal training intervention lasting 8 weeks. Pre- and post-testing     involving vocal functioning assessments, as well as mobility, psychosocial, and cognitive     functioning assessments will be conducted. This interdisciplinary project will enhance the     investigators understanding of physical, mental, and social health-related quality of life     among older adults.   "
20570|NCT03016299|"     The subchondral bone, formed by the subchondral bone plate and the subarticular spongiosa,     plays a key role in supporting the articular cartilage. Marrow stimulation techniques such as     subchondral drilling are clinically important treatment options for symptomatic small     cartilage defects. However, The heat generated from the metal-bone interface during drilling     due to the friction can cause thermal osteonecrosis. , recent clinical evidence suggests that     they may induce alterations in the subchondral bone plate such as intralesional osteophytes,     which persist and may play a role in the degeneration of the repair tissue.      Little is known about whether they induce deleterious changes in the Human Chondral &     Subchondral bone.      The aim of this study was to compare the condral & Sub-chondral Histoligical damage induced     by different drilling techniques.      To the best of our knowledge this is the first time to inspect it, In- Situ, on Human tissue.   "
20571|NCT03016286|"     Hypotheses of this study are        1. Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body          vibration (WBV)        2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this          study is to test these hypotheses.      Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied at     35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20     minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling of     the right ankle, and during WBV respectively.   "
20572|NCT03016273|"     Cesarean section is a surgical procedure used to deliver one or more babies. cesarean section     is usually performed when vaginal delivery will put the mother or child's health or life at     risk. In recent years, the number of cesarean section has risen worldwide.   "
20573|NCT03016260|"     RABIOPRED is an in vitro non-invasive blood test, which aims to identify patients with     rheumatoid arthritis (RA) who are not likely to respond to anti-TNFα and methotrexate     combination therapy.   "
20574|NCT03016247|"     The purpose of this pilot study is to evaluate the effect of the Trust-building weight     Self-management Together (TRUST) intervention on weight self-management behaviors and neural     processing in overweight/obese adolescents. Study aims include comparing the effects of the     TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese     early adolescents and exploring differences in neural processing (DMT/TPN switching and     reward activation).   "
20575|NCT03016234|"     This study is aimed to evaluate how intraocular pressure (IOP) is changed depending on     surgical position (Trendelenburg versus reverse Trendelenburg) in the same patient and to     compare the effects of different anesthetics on IOP (desflurane versus propofol) in patients     undergoing laparoscopic colorectal surgery. The study design is a double-blind randomized     controlled trial. The patients were randomly assigned to desflurane or propofol administrated     groups and all patient are administered intravenous remifentanil continuously as adjuvant     analgesics during anesthesia. For this study 50 to 80-year-old patients undergoing     laparoscopic colorectal surgery without eye disease were enrolled. Mean arterial blood     pressure, peak airway pressure, end tidal carbon dioxide, and IOP (using a Tono-pen® Avia     tonometer) on both eyes were measured at defined intervals during the procedure.   "
20576|NCT03016221|"     The use of topical over-the-counter (OTC) products with a warming or cooling effect is     widespread in the fields of sport, physiotherapy and in private households. Advertisements     for such products promise pain relief when suffering from musculoskeletal disorders such as     muscle tension, rheumatism or acute injuries, e.g. sprains. In literature, there are only     little information about the efficacy and the physiological mechanisms of topical warming or     cooling products. Therefore, the aim of this study is to investigate the local skin     characteristics during and after an application of a topical product with a warming or     cooling effect.   "
20590|NCT03016039|"     To use curcumin supplementation as an additive treatment to induce clinical, biochemical     response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian     abcess, Endometritis, wound infection.      Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection     patients may augment clinical and biochemical response and accelerates the improvements of     the sign symptoms and reported outcomes of those diseases.   "
20591|NCT03016026|"     This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on     laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS     program.   "
20577|NCT03016208|"     Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for     labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.      Design: Non-interventional observational case control study.      Setting: Tertiary-care academic centre in Germany.      Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.      Methods: Induction of labour with MVI in a consecutive series of women using standard     (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.      Main outcome measures: The primary outcomes were the time from induction to delivery and the     caesarean section rate. The secondary outcomes included the need for additional measures to     induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained     amniotic fluid, umbilical arterial pH, and Apgar score.   "
20598|NCT03015935|"     Laparoscopic surgery has become very popular and standard in many indications after     advancements of technique. Various methods have been used in first entry to the abdomen.     Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are     important. Several techniques, instruments, and approaches to minimize the risk of injury     (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have     been introduced.      There is no consensus yet on an optimal method has yet emerged.      The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of     the first trocar at any site of the abdomen.      To evaluate the efficacy of entry technique, the investigators used cohort of patients who     will be planned to laparoscopic obesity surgery.      Two methods are commonly used in surgical literature and in our center.      The investigators have been used visible optical-entry technique in some patients for first     entry and Veress technique in some other patients.      For this purpose, the investigators designed an observational study.   "
20604|NCT03015857|"     Hypotension following spinal anesthesia for cesarean section is a serious problem. In this     study we investigated the effect of the vasopressors phenylephrine and noradrenaline on     postspinal hypotension.   "
20578|NCT03016195|"     Oral sodium supplementation is currently administered in cases of poor weight gain in infants     particularly in patients who have undergone gastrointestinal surgical procedures. The     decision to start oral supplementation is based on urinary sodium levels although the level     at which to start treatment is variable as the range in normal, healthy infants is unknown.     This study aims to ascertain the normal range of sodium in urine specimens collected from     healthy newborn babies.      It is believed that by increasing the level of salt in the intestine, glucose can be more     easily be absorbed and therefore weight gain improved. Babies with conditions where they are     at risk of salt depletion (i.e. those with a stoma) are currently administered oral sodium     supplementation if they are failing to gain weight and have an associated 'low' urinary     sodium level. Low levels of urinary sodium are considered to represent a state of low body     sodium levels, as the kidneys attempt to reabsorb most of the sodium in the urine before it     is excreted.      Current practice varies widely as to the level below which treatment should be instigated.     Some centres advise below 20 mmol/L (Birmingham Children's Hospital and Nottingham Children's     Hospital guidelines), others below 10 mmol/L (University Children's Hospital, Zurich). In     Glasgow, babies with poor weight gain are given sodium supplementation if urinary sodium     levels are below 40 mmol/L. There are no documented ranges for the levels of urinary sodium     in healthy, newborn babies.      By determining the reference range of urinary sodium levels in healthy, term babies who are     gaining weight appropriately, the investigators hope to be able to have a better     understanding about both the level below which supplementation should be considered and the     target range that should be aimed for.   "
20579|NCT03016182|"     During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a     problem complicating the postoperative course of the patients.Remote ischemic     preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple,     cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that     RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the RIPC     can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still     uncertain.      The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect     and improve clinical outcomes in patients undergoing cardic surgery.   "
20580|NCT03016169|"     The objective of this study is to evaluate the safety and performance of the Trifecta™ GT     (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world     setting. This study is intended to satisfy post-market clinical follow-up requirements of CE     Mark in Europe.   "
20581|NCT03016156|"     This study seeks to determine whether a smartphone application called CRADLE (ComputeR     Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria.     There will be no impact on participants' health outcome.      This study will be performed in two parts, each with a distinct cohort of patients.      Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within     patients known to have leukocoria.      Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using     the techniques selected from information gathered in Part 1) as compared to an     ophthalmoscope, within patients referred to the clinic for suspected leukocoria.      PRIMARY OBJECTIVES:        -  To determine the most effective usage of a camera phone application (CRADLE) to maximize          detection of leukocoria in patients with retinoblastoma, congenital cataracts, and          glaucoma.        -  To estimate the sensitivity and specificity of a camera phone application (CRADLE) in          detecting leukocoria.   "
20582|NCT03016143|"     The study is a single centre, phase II, double-blind, randomized, comparative trial that     explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal     influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18     to 60 years of age and older than 60 years).   "
20583|NCT03016130|"     This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a     liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in     patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and     common sense advice listed in the FDA-endorsed food safety guidelines.   "
20584|NCT03016117|"     The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during     quadrantectomy with or without axillary dissection, in breast cancer surgery   "
20585|NCT03016104|"     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and     its safety for bipolar mania. Half of the participants will receive MST, while the other half     will receive electroconvulsive therapy (ECT).   "
20586|NCT03016091|"     A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and     Anaplastic Meningioma   "
20587|NCT03016078|"     The overall rationale for this investigation is to evaluate the clinical performance     potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related     post-operative wound complications such as blistering, maceration and redness at the incision     and surrounding skin.   "
20588|NCT03016065|"     The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber     on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota     composition and activity.   "
20589|NCT03016052|"     this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in     response to deviations from the embedded contingency in attention bias modification treatment     (ABMT) for social and generalized anxiety, and the interaction between vMMN emergence and     clinical improvement.   "
20596|NCT03015961|"     Primary Objective: The primary objective of this study is to compare postsurgical pain     control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine     HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar spinal fusion     surgery.      Secondary Objectives: The secondary objectives of this study are to compare additional     efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with     bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar     spinal fusion surgery.   "
20597|NCT03015948|"     This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose     Phase I trial.   "
21948|NCT02998320|"     This study measures the proportion of enrolled patients taking the uninterrupted HIV     post-exposure prophylaxis Genvoya for four weeks   "
20607|NCT03015818|"     Structural valve dysfunction (SVD) is the most common and life threatening complication in     patients treated by aortic valve replacement. A calcification process is frequently involved     in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic     phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than     a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with     18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.      This study will include patients with echocardiography-confirmed SVD. Echocardiographic     parameters and other current parameters analyzed in SVD patients such as bioprosthesis     calcium scoring derived from CT will be compared to 18F-Fluoride activity.   "
20608|NCT03015805|"     The purpose of this study is to examine the effectiveness of Juvenile Probation Officers     (JPOs) delivering Contingency Management (CM) to teens on their caseload who have problems     with drug use. CM has already been shown to be effective at helping teens with drug problems     but CM has never been delivered by JPOs. This study will test how well it works to have JPOs     deliver CM during their regular meetings with teens.   "
20609|NCT03015792|"     This phase I/II trial studies the best dose and side effects of ibrutinib when given together     with lenalidomide and dexamethasone and how well they work in treating patients with multiple     myeloma that are not eligible for transplant. Ibrutinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving ibrutinib, lenalidomide, and dexamethasone may work better in treating     patients with multiple myeloma.   "
20617|NCT03015688|"     It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of     osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine     whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee     OA cases were collected from the first affiliated hospital of Shihezi university and healthy     controls were recruited from the community. The severity of knee OA was defined as     kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were     compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum     concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .   "
20618|NCT03015675|"     Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high     dose vitamin C to treat cancer patients forty years ago. Their studies have shown that high     dose vitamin C usage could significantly prolong overall survival of patients with advanced     cancer. Recently, preclinical study has shown that human colorectal cancer cells harboring     KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High dose     of AA impairs tumor growth in Apc/KRASG12D mutant mice. Previous phaseⅠclinical trials have     found that high dose (1.5g/kg or 90g/m2) iv AA is well tolerated in cancer patients. This     protocol is a phase Ⅲ, study of ascorbic acid (AA) infusions combined with treatment with     mFOLOX6 versus mFOLOX6 alone as first-line therapy in patients with recurrent or advanced     gastric cancer.   "
20619|NCT03015662|"     Objectives: The purpose of the current randomized clinical trial is to compare the     effectiveness of dry needling versus myofascial release therapy on myofascial trigger points     (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and     depression in patients with fibromyalgia syndrome (FMS).   "
20620|NCT03015649|"     The purpose of this study is to evaluate the performance of FDA-cleared SAVI SCOUT Breast     Localization and Surgical Guidance System (SCOUT) over a longer duration prior to surgery.     The device is a non-wire system, which uses nonradioactive light-activated radar, to provide     breast surgeons with real-time guidance to locate and remove the target lesion in the breast     and/or axillary tissue. The SCOUT device standard of care use is placement up to 30 days     prior to surgery to assist surgeons in the localization and retrieval of breast/axillary     lesions. Routine image-guided methods (Mammography, Ultrasound, and CT) are used. In this     study, investigators will assess the longer term placement of the SCOUT device over an     extended time (31 - 365 days) in order to address the needs of patients who require     neoadjuvant treatment prior to definitive surgery.   "
20621|NCT03015636|"     Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). Many patients     in psychiatric care have sleep problems including insomnia, but are rarely given the choice     to participate in CBT to improve their sleep. Patients with ADHD is a patient group with high     levels of sleep difficulties. Sleep problems in this patient group can be both more general     such as insomnia, but can also be related to the ADHD itself and to the use of ADHD     medication. In a previous pilot study, the investigators developed a version of CBT-i that     would target sleep problems in this population. The basis was CBT-i, but with more emphasis     on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication),     techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light     and darkness), and techniques to target more general sleep disturbing habits (e.g. not     winding down before bed time), that are also common in patients with ADHD. This treatment was     well tolerated and gave moderate effects on insomnia severity in the pilot study. In a     naturalistic randomized controlled trial, the investigators now evaluate the effects of this     psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics,     Northern Stockholm Psychiatry, Sweden.   "
20622|NCT03015623|"     The purpose of this study is to assess the safety and tolerability of the investigational     product, SBI-101, in subjects with Acute Kidney Injury (AKI). SBI-101 is a biologic/device     combination product designed to regulate inflammation and promote repair of injured tissue     using allogeneic human mesenchymal stromal cells. Patients will be randomized to receive one     of three treatments, low dose SBI-101, high dose SBI-101, or sham control. SBI-101 will be     integrated into the renal replacement circuit and patients will be treated for up to 24     hours.   "
20623|NCT03015610|"     This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of     lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It     will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma     control.   "
23119|NCT02983006|"     The purpose of this study is to evaluate the safety profile, tolerability, and     immunoregulatory (pharmacodynamic; PD) activity of DS-8273a administered in combination with     nivolumab (anti-PD-1 antibody) to subjects with unresectable Stage III or Stage IV melanoma.   "
20627|NCT03015558|"     The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the     opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in     both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by     tDCS will be assessed using both laser stimuli and cold pressor test. In patients the     assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep     and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage     and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular     cortex). In patients, three separate conditions (two active and one sham) will be tested in     randomised order. In healthy subjects, two other conditions are added to control for     attention and distraction confounders.   "
20770|NCT03013699|"     This study will examine the effects of a dietary intervention in post-treatment head and neck     cancer survivors on the ability to function physically, tiredness, and quality of life, as     well as on changing markers in the blood that are associated with better recurrence and     survival.   "
20628|NCT03015545|"     Whole body vibration is an exercise modality that could modulate tissue blood perfusion and     neural reflexes, and thus may have the potential to alter muscle stiffness through modulation     of contractile properties or/and neurological adaptation. However, the potential effects of     WBV on leg muscle stiffness in stroke rehabilitation remains unknown. The overall aim is to     investigate the effects of whole body vibration (WBV) on leg muscle stiffness and Hoffman     reflex (H-reflex) and to identify the optimal vibration parameters that may reduce leg muscle     stiffness among people with stroke.   "
20629|NCT03015532|"     This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled,     multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to     evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered     via infiltration to the surgical site.   "
20630|NCT03015519|"     The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment     options are limited in children and adolescents. Albiglutide, approved for the treatment of     T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a     sufficiently long half-life to permit once a week injection. The study will be conducted in 2     parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of     albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a randomized     double-blind placebo controlled study to evaluate the safety and efficacy (glycemic control)     of albiglutide in the pediatric population. Treatment duration in Part B is 52 weeks (24     weeks double-blind placebo-controlled and 28 weeks open-label during which all subjects will     receive albiglutide). Approximately 210 eligible male and female subjects will be included in     the study.   "
20631|NCT03015506|"     The objective of this study is to determine the glycemic index of 4 pulse-based breads in at     least 10 normal healthy human volunteers. Participants will be studied in the morning on 6     separate days after overnight fasts. On the first and last days they will consume a test meal     consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they     will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch     obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over     2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area     under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after     white bread.   "
20632|NCT03015493|"     The purpose of the study is to examine the effects of cervical traction with or without the     addition of neural mobilization, in patients with cervical radiculopathy   "
20633|NCT03015480|"     This study will test the effectiveness of remotely delivered medical nutrition therapy (MNT),     focused on increasing fruit/vegetable intake, and decreasing sodium and red/processed meat     intake, in the treatment of patients with stage 1-2 chronic kidney disease (CKD) and     diabetes.   "
20634|NCT03015467|"     Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most     patients with severe pancreatitis associated with intestinal mucosal barrier     dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play     an important role in the development process in the course of severe acute pancreatitis. At     this stage of the study that infection of pancreas and other organs is the leading cause of     death in patients with severe acute pancreatitis，and the main pathogens from intestinal     micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota     Transplantation that has been used for treatment of inflammatory bowel disease and     Clostridium difficile infection may be a new technology for regulation of intestinal mucosal     dysfunction and intestinal flora unbalance.   "
20635|NCT03015454|"     A sepsis early warning predictive algorithm, InSight, has been developed and validated on a     large, diverse patient cohort. In this prospective study, the ability of InSight to predict     severe sepsis patients is investigated. Specifically, InSight is compared with a well     established severe sepsis detector in the UCSF electronic health record (EHR).   "
20636|NCT03015441|"     The purpose of this study is to assess the effect of a 28-day fermented milk product     consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in     healthy subjects high H2 producers.   "
20637|NCT03015428|"     This study aims to experimentally evaluate the training program for family caregivers of     people with dementia_Living together with Dementia.   "
20638|NCT03015415|"     This study compares patients with post traumatic elbow stiffness and evaluate the range of     motion improvement with two types of treatment: surgical release versus non-surgical     rehabilitation protocol with orthoses.   "
20639|NCT03015402|"     The main objective of this study is to determine the clinical efficacy of oral inorganic     nitrite verses placebo and the therapeutic response with regards to exercise tolerance in     patients with pulmonary hypertension and heart failure with preserved ejection fraction     (PH-HFpEF).   "
20680|NCT03014869|"     For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as standard     therapy, which can reduce the rate of intubation and mortality. A few previous studies have     shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some     severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for     preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we     performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD     patients.   "
20640|NCT03015389|"     This is a multi-center, prospective, randomized study which will enroll patients undergoing     endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of     the research team will approach a potential subject to discuss participation in the study,     including background of the proposed study, inclusion and exclusion criteria, benefits and     risks of the procedures and follow-up. If this is of interest to the subject, the informed     consent form is discussed and presented. The subject must sign the consent form prior to     enrollment. This form will have prior approval of the study site's Institutional Review Board     (IRB). Failure to obtain informed consent renders the subject ineligible for the study.   "
20641|NCT03015376|"     Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and mismatch     repair genes in patients with epithelial ovarian cancer (EOC) and their relatives, and     related somatic mutations in tumor tissues in the northern part of china.      Patients and methods: A multicenter prospective study will be hold in the northern part of     china form 2017. About 1000 female patients with epithelial ovarian cancer and their     ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes and     related somatic mutations in tumor tissues, regardless of the family history.      Study type: Observational Official title: Prevalence study of germline mutations in     susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic     mutations in their tumor tissures in the northern part of china.      Enrollment: 1000   "
20642|NCT03015363|"     The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate     and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard     for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient     participants who are scheduled for an elective cardiac catheterization procedure for     clinically valid reasons.   "
20643|NCT03015350|"     16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will     recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply     in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two     lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be     performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will     given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two     lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time     interval of 10 minutes after one lung ventilation started. All blood samples will be assess     in Gas Chromatography.   "
20644|NCT03015337|"     This study examined how well elementary students demonstrated motor skill competency as a     result of participating in the evidence-based quality physical education program and     investigated relationships between levels of health-related physical fitness and physical     activity in school-aged children.   "
20645|NCT03015324|"     Hydroxychloroquine will be administered on an outpatient basis within 12 weeks after primary     surgery followed by adjuvant chemotherapy /or radiation therapy (if needed).     Hydroxychloroquine will be administered orally at a dose of 400 mg daily for 90 days.     Subjects will receive HCQ every day.   "
20646|NCT03015311|"     The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a     2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The     purpose of this trial is to test whether a treatment program aimed at reducing systolic blood     pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently recommended     (<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of     old. Furthermore, this trial will also examine the effect of blood pressure APP management     strategy via WeChat network on medication compliance, blood pressure control and CVD     benefits.   "
20647|NCT03015298|"     The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.   "
20648|NCT03015285|"     Adults with high anxiety sensitivity (AS) and a mental health diagnosis of anxiety,     depression, or posttraumatic stress will be recruited and will be randomly assigned to either     transdiagnostic cognitive behavioural therapy (CBT) for AS or disorder-specific CBT for their     primary mental health problem. The study outcomes - AS, anxiety, mood, and substance use     symptoms, and functional impairment - will be assessed at pre-and post-treatment and 6 and 12     months post-treatment via standardized self-report measures completed by participants and a     standardized diagnostic interview.   "
20649|NCT03015272|"     The goal of the Novel Language Intervention for minimally verbal children with Autism     Spectrum Disorder (ASD) is to test the efficacy of one experimental treatment (AMMT) compared     to baseline assessments and compare the AMMT efficacy to a control intervention (SRT), both     treatments were designed to facilitate speech output in minimally verbal 5.5 to 12.0 year     olds. This study aims to compare the two interventions (one intonation-based; the other     non-intonation-based) in a single-blind, randomized controlled trial (RCT) that includes a     comprehensive baseline assessment battery, 25 intensive 1-on-1 treatment sessions conducted 5     days/week, and a series of probe assessments administered at multiple timepoints pre-,     during, and post-therapy.      Despite the complex needs of minimally verbal children with ASD and the wide variety of     treatments available to address many of those needs, there is still a great need for     effective methods that promote the development of speech sounds and facilitate the production     of those sounds in this growing population. While the primary aim of this RCT is to     investigate the effects of AMMTversus a control intervention (SRT) on minimally verbal     children with ASD and compare the two interventions to determine whether one is more     effective than the other, this study also aims to examine whether baseline cognitive skills,     speech praxis, joint attention abilities and/or neural architecture can predict the effects     of treatment with AMMT or SRT in minimally verbal children with ASD.   "
20650|NCT03015259|"     A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week     run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide     80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation     aerosol.   "
20651|NCT03015246|"     This research deals with behaviors that are part of opioid dependence. The purpose is to     study how stress and medication dose can affect opioid drug use.   "
20681|NCT03014856|"     This study provides a sound basis towards a better understanding of the biochemical     mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great     importance towards the development of more personalized prevention and treatment in future.   "
20652|NCT03015233|"     Abdominal pain is one of the most common reasons for consultation in Emergency Departments     (ED) worldwide. The challenge for physicians is to not misdiagnose a surgical emergency. The     actual gold standard for diagnosis is computed tomography (CT). However with this procedure     there is high radiation exposure and a risk factor of radiation-induced cancers, therefore     alternative diagnostic techniques should be considered. The aim of this study is to evaluate     the performance of measuring venous lactate in patients presenting with acute abdominal pain     in ED.      In this single-center, prospective, non-interventional study, the diagnostic accuracy of     venous lactate in order to detect surgical emergencies is evaluated. The hypothesis made here     is that venous lactatemia is a positive predictive factor of surgical emergencies in patients     with acute abdominal pain.   "
20653|NCT03015220|"     This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy     of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic     drug) in Japanese subjects with type 2 diabetes.   "
20654|NCT03015207|"     This trial is conducted in The United States of America. The aim of this trial is to     investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the     body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.   "
20781|NCT03013556|"     The current study is a prospective, randomized, open, multi-center investigation. The aim of     the study is to investigate whether the HBeAg seroconversion rate can be improved if applying     combination therapy in HBeAg positive CHB patients who has achieved     HBVDNA<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.   "
20655|NCT03015194|"     Background:      Transcatheter mitral valve replacement (TMVR) is recommended for some people with heart     problems. But the usual TMVR techniques might cause an obstruction for some people. A new     technique is called LAMPOON. It may have less risk of obstruction. Participants in this study     will be among the first in the world to have this technique done.      Objectives:      To test the safety and effectiveness of the LAMPOON technique in TMVR.      Eligibility:      Adults ages 21 and over who are recommended to have TMVR with LAMPOON      Design:      Participants will be screened with medical history and exam and by review of medical records.      Participants will have blood tests, a scan, and a heart test before the procedure.      Participants will have TMVR with LAMPOON. They will have anesthesia. Doctors will use a wire     to split the diseased mitral valve and move it out of the way. They will replace a heart     valve.      Participants will stay in the hospital for about 1 month.      They will repeat the previous tests before leaving the hospital, 1 month later, and 1 year     later.      They will have yearly follow-up phone calls for about 5 years.      In the event of a participant's death, researchers will ask for an autopsy and to analyze the     heart. Permission for this is not required as part of the study.   "
20656|NCT03015181|"     Background:      Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to     fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent     mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat     HIV-1 infected people.      Objective:      To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy     adults.      Eligibility:      Healthy people ages 18-50      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Participants will be assigned to 1 of 7 groups:      Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.      Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48     weeks.      Participants will get the drug in 1 of 2 ways:      Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6     hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will     have 4-5 visits in the week after their second and third doses.      Injection into the fatty tissue under the skin. Participants will have blood tests before the     injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits     after the second and third doses.      Visits include:      Physical exam      Blood and urine tests      Optional oral swabs to collect saliva      Participants will keep a diary of their temperature and symptoms for 3 days after each dose.   "
20657|NCT03015168|"     We explored the relationship between NLR and grade 3 or higher treatment related small bowel     toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and     concurrent intensity modulated radiotherapy (IMRT).   "
20658|NCT03015155|"     Recent clinical studies have shown that systemic therapeutic hypothermia improving the     outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary     percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have     described the methods, mechanism and rationale of therapeutic hypothermia, including local     myocardial hypothermia. However, little is known of the local myocardial hypothermia having     impact on prognosis of the patients with acute myocardial infarction. The aim of this study     is to ascertain whether local myocardial hypothermia is effective in treatment of     ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.   "
20659|NCT03015142|"     There is a clear need in spine surgery to place pedicle screws in the right place in the     spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or     vertebral arteries). The objective of the study is to investigate the accuracy of screw     placement during spine surgery.   "
20660|NCT03015129|"     This study will test the safety and efficacy of the experimental drug called durvalumab with     or without another experimental drug called tremelimumab in endometrial cancer.   "
20682|NCT03014843|"     The aim of this study was to investigate the effect of naloxone (IV or IM administration) and     methylnaltrexone (subcutaneous administration) on esophageal sensitivity, in a group of     healthy volunteers in order to evaluate the role of endogenous opiods in symptom perception     in gastro-esophageal reflux disease. Esophageal sensitivity was assessed by using a     multimodal esophageal stimulation protocol where sensitivity to thermal, mechanical,     electrical and chemical stimulation was tested.   "
20683|NCT03014830|"     Alirocumab is an injectable treatment for elevated blood cholesterol. The hypothesis of this     study is that it also increases cholesterol excretion from the body into the stool, a process     sometimes called reverse cholesterol transport. A cholesterol metabolic study will be done     before and after 6 weeks of alirocumab treatment. If alirocumab increases reverse cholesterol     transport, it is possible that this action provides additional protection from cardiovascular     disease.   "
20661|NCT03015116|"     BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot,     results in pain-related disability in Service Members and beneficiaries and contributes to     decreased physical activity and excessive healthcare costs. Even if effective, current     treatment protocols may require 6-12 months of therapy to return individuals to pain-free     activity. Photobiomodulation (PBM), or low level laser therapy, uses non-ionizing light to     elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence     supports use of PBM for other degenerative connective tissue conditions, such as Achilles     tendinopathy and epicondylitis. Unfortunately, previous studies of PBM for treatment of     plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on     its clinical effectiveness.      SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in     conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the     clinical effectiveness of photobiomodulation in conjunction with and compared to usual care     to improve function and decrease pain and in patients. 3. Assess the difference between two     photobiomodulation dose parameters in conjunction with and compared to usual care for plantar     fasciitis treatment.      DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims     of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be     randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus     PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6     month) follow-up, measures of foot function and pain will be collected for analysis. The     proposed methods will allow the study team to establish if PBM accelerates recovery compared     to usual care, as well as determining the optimal dose for future trials comparing PBM to     other, more invasive, therapies for plantar fasciitis.   "
20662|NCT03015103|"     The purpose of this study is to prove the product tested does not cause photoirritation or     photosensitization reactions when exposed to sun light.   "
20663|NCT03015090|"     The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect     metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary     disease patients.   "
20685|NCT03014804|"     This phase II trial studies the side effects of autologous dendritic cells pulsed with tumor     lysate antigen vaccine and nivolumab and to see how well they work in treating patients with     glioblastoma that has come back. Vaccines made from a person's tumor cells may help the body     build an effective immune response to kill tumor cells. Monoclonal antibodies, such as     nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic     cell-autologous lung tumor vaccine and nivolumab may work better in treating patients with     glioblastoma.   "
20782|NCT03013543|"     The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight,     hunger assessments and other factors in patients with rare genetic disorders of obesity,     including POMC deficiency, LepR deficiency, Bardet-Biedl syndrome and Alström syndrome.   "
40839|NCT02751060|"     The purpose of this study is to determine whether the expression level of miR-320a are     effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of     coronary heart disease.   "
20664|NCT03015077|"     The rapidly increasing mortality and incidence of oral cancer has become a public health     major problem in Taiwan. To date, the treatment of head and neck cancer mainly include     surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an     influence on the patients' diet by causing dismal side effects, including nausea, vomiting,     pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the     patients more difficult to absorb nutrients. In the previous study, the incidence of     malnutrition among the patients with cancer has been estimated at between 40 and 80%,     especially occurred in the patients with head and neck cancers and upper gastrointestinal     cancers.      In this study, the effect of supplement with L-Glutamine on the nutritional status and     radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the     patients' quality of life when they are undergoing radiotherapy. When the head and neck     cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of     L-Glutamine are performed to maintain the patients' nutritional status and reduce the     patients' diet-related or other side effects caused by radiotherapy. It is anticipated that     head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might     decrease treatment-related side effects and hence improve their quality of life when they are     undergoing radiotherapy.   "
20665|NCT03015064|"     Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the     diagnosis of the first acute myocardial infarction from July 2016 until December 2020.   "
20666|NCT03015051|"     Bronchiolitis is the most common respiratory infection of the lower respiratory tract that     affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with     bronchiolitis require hospital admission because of poor feeding and/or breathing     difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and     hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of     the techniques of administration of oxygen in bronchiolitis is represented by the high flow     (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC     provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces     breathing load and allows for better nutrition. The main aim of therapy with high flows is to     reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have     been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this     topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot     study of 19 subjects comparing HFNC with oxygen administered via head box. The oxygen     saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs     96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available     evidence is insufficient to determine the effectiveness of HFNC.      The aim of this study is to evaluate in a large number of cases the effectiveness of     treatment with high flow versus standard treatment, in children with bronchiolitis referred     to a Pediatric Emergency Department.   "
20667|NCT03015038|"     Duration of each part of the study per patient:        -  Screening: From 1 to 4 weeks        -  Sampling period (blood and tissue): 1 day        -  Follow-up by patient: 60 months        -  Total study duration by patient: 84 months        -  Total inclusion duration: 24 months        -  Total Follow-up duration: 60 months        -  Total study duration: 84 months   "
20668|NCT03015025|"     The use of coumarins has been a challenge for doctors because of its narrow therapeutic range     and they show great inter and intra-individual variability in the dose necessary to achieve     an international normalized ratio (INR) within the therapeutic range. Among the factors     influencing the interindividual variability in the dose required include age, weight, Vitamin     K in the diet, comorbidity as well as drug interactions and in recent years has also seen the     importance of pharmacogenetic factors.   "
20669|NCT03015012|"     The investigators hypothesize that compared to the provision of population-based dietary     advice, providing DNA-based dietary advice via personalized nutrigenomics testing (PNT) to     two distinct patient populations (Family Health Team patients receiving a lifestyle     counselling intervention and transplant recipients) will motivate them to adopt healthier     dietary habits, lead to greater fat loss, increased percent lean mass and therefore improve     health and quality of life outcomes for both patient populations. The second hypothesis is     that dietary strategies related to the intake of one or more dietary components of interest     will mitigate post-transplant weight gain associated with three SNPs of interest.      This is a randomized clinical intervention trial involving a total of four groups of patients     (n = 400). The two main patient groups include overweight or obese, stable transplant     recipients and overweight or obese patients who are attending group counselling sessions at     the East Elgin Family Health Team. Within these two main groups, there will be two     sub-groups. Patients will be randomized to receive either PNT or standard nutrition     intervention (SNI). Baseline data will be conducted consisting of a food frequency     questionnaire and three-day food records using a validated multiple pass method.     Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to     derive percent body fat and lean mass. Weight and height will be measured using a weigh scale     and stadiometer. Those patients randomized to the PNT group will be instructed on a tailored     nutrition care plan and physical activity recommendations based on their individual     nutrigenomics profile. At the same time, the SNI group will be instructed on general     nutrition and physical activity recommendations for weight loss, which include the use of     dietary strategies from the standard tool ('Just the Basics') used by registered dietitians     for transplant patients and patients attending the Family Health Team sessions. Monthly email     reminders or phone calls (depending on patient's preference) will be sent to all participants     as a reminder of their nutrition plan. Three months, six months and twelve months after     baseline data collection and individual nutrition interventions, baseline data will be     repeated. After the study is complete, participants in the SNI group will be offered a     nutrigenomics report and consultation with a registered dietitian.      A paired t-test or repeated measures ANOVA will be used to assess within group change from     baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. A     repeated measures ANOVA will be used to test between group differences from baseline to each     follow-up time point for: BMI, body fat, lean mass, and dietary intake. If significant mean     differences are detected, a Tukey's post hoc test will be used to compare differences by     group. Statistical significance will be determined by P < 0.05. General linear regression     models will be used to assess interactions between each genotype of interest and each dietary     component of interest on BMI and body composition from baseline to each follow-up time point.   "
20670|NCT03014999|"     A crossover trial with spinal cord injury volunteers will be conducted. Three sessions will     be performed once a week in a counterbalanced order and at least with seven days washout     period to minimize carry-over effects. In each session, volunteers will be submitted to     quantity and quality of sleep, type of eating, fatigue and motivation level, Ashworth scale     spasticity, cortical brain activity measures through simple pulse transcranial magnetic     stimulation (pTMS), spinal cord activity measures through electrical stimulation and     non-invasive brain stimulation (rTMS)   "
20706|NCT03014531|"     The study was conducted to investigate the effects of daily almond intake based on the timing     of almond consumption (i.e., almond consumption as a preload or between-meal snack) on body     composition, lipid profile, and oxidative and inflammation indicators among young Korean     adults.   "
21084|NCT03009604|"     Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which     thereby decreases the total colony count of bacteria, thus, decreasing peritoneal     contamination in case of bowel injury, improving the access to the surgical field and     facilitating intraoperative bowel manipulation   "
20671|NCT03014986|"     The availability of novel therapies with DAAs might prompt clinicians caring for HSCT     recipients with HCV infection to prescribe the treatment more frequently and possibly earlier     after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most     appropriate one is not straightforward. It depends not only on its efficacy, toxicity and     rate of pharmacological interactions, but also on availability (both through healthcare     system and in expanded access programs), and cost.      This observational prospective study will focus on treatment strategies in HSCT recipients     with HCV infection. The main focus will be the therapeutic approach, the combination of drugs     chosen, the length of treatment and the outcome. The main reasons for treating or not     treating HSCT recipients with HCV infection will be also explored. Compared to previous     cohorts, this study might provide additional data in the area of non-invasive assessment of     fibrosis, HCV-RNA levels and genotyping.      In order to get as much data as possible on HCV treatment, patients with chronic HCV     infection transplanted during the last 10 years will be included.      Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016     will be reported.   "
20672|NCT03014973|"     The main objective of the study is to determine the intra-prostatic concentration of sexual     steroids when castration resistance appears in castration-resistant prostate cancer patients     compared to patients naif of hormonal treatment   "
20673|NCT03014960|"     The purpose of the study is to investigate the effects of sleep improvement in leaders on     leader outcomes.   "
20674|NCT03014947|"     This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation     Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal     Product (RMP) (Humira®) in healthy subjects.   "
20675|NCT03014934|"     Via a prospective non-interventional study clinical outcome of patients with - and without -     history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in     terms of non-relapse mortality overall mortality and fungal infectious morbidity.      Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of     pre-existing IA vs. no pre-existing IA.      Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%)     than patients without pre-existing IA.      Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell     grafts.      Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of     probable or proven invasive aspergillosis: this cohort includes also the patient with a     history of possible mycosis not documented microbiologically.   "
20676|NCT03014921|"     This trial study and compare in blood and urinary matrices the impact of an iron injection on     proteins involved in iron metabolism during a blood donation. The goal is to study the impact     of an iron injection on detection markers of a blood donation in the anti-doping field   "
20677|NCT03014908|"     The aim of this study was to look for discriminating variation in the concentrations of     small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched     controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.   "
20678|NCT03014895|"     The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled,     single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate     the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous     dose of E3112.   "
20679|NCT03014882|"     Accumulation of iron in patients with beta thalassemia major causes free radical formation     which leads to damage of biological membranes. Sperm DNA damage may result from these     generated antioxidants.      We aimed at investigating the current DNA damage in the sperms of adult patients with beta     thalassemia major and the effect generated by giving antioxidant treatment for 6 months.   "
20684|NCT03014817|"     The present study aims at analyzing whether ultrasonic tissue coagulation dissection     technique offers a smoother peri- and postoperative course and reduces the risk for     conversion from laparoscopic to open surgery in acute cholecystectomy patients as compared to     electrocautery in case of acute cholecystitis The study is performed as a double-blinded     study on patients undergoing laparoscopic surgery for acute cholecystitis. Patients included     in the study are randomized to surgery with either the traditional electrocautery based     technique or ultrasonic scalpel based dissection.   "
20707|NCT03014518|"     Suicide is one of the most devastating events in society at all levels. The primary goal of     this study is to predict suicide in adolescents at risk. We will utilize blood biomarker     measurement and clinical risk factor scales to develop a tool to identify adolescents at risk     for suicide earlier, which will allow clinicians to prescribe timely treatment and prevent     suicide.   "
20686|NCT03014791|"     Hypertension, also known as high blood pressure, is a chronic medical condition, in which the     blood pressure is elevated. This is a common condition, which can lead to severe     complications such as cardiovascular disease, heart attack, stroke and kidney disease, if not     detected and treated early.      Accumulating evidence suggests that the incidence of hypertension varies according to age,     ethnicity and obesity. In order to obtain an in-depth knowledge of the pathophysiological     mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical correlates     of elevated blood pressure across the adult age-span, and determine the extent to which body     size and ethnicity impact on these associations. We also wish to investigate the impact of     hypertension on key target organs (end-organ damage). The primary objective of this study is     to compare the mechanisms regulating blood pressure in hypertensive and non-hypertensive     participants across the adult age span, and to assess the influence of body mass index and     ethnic background on these mechanisms. Secondary objectives are to investigate the     association between blood pressure and cardiovascular physiology across the adult age span at     rest and during sub-maximal exercise and to investigate the impact of blood pressure     haemodynamics on key organs including the arteries and heart by assessing end-organ damage     such as endothelial function, arterial structure and left ventricular mass/function.      This study will be a combined case-control and cross-sectional study describing the     procedures and time commitment required to investigate our scientific aims. This is a single     centre study that will be conducted in a secondary care environment. Both male and females     aged 18 and over and that are able provide informed consent will be considered for this     study. People who are pregnant, currently receiving dialysis, illness with a life expectancy     <1 year, current active malignancy and cannot provide informed consent are ineligible for     this study. The study will be open for five years and each patient will complete a maximum of     four visits in a 12 month period. Participants will complete a variety of non-invasive     physiological assessments of their cardiovascular system and lung function. There will be     some minimally invasive procedures completed, including a blood test and assessment of small     artery endothelial function which involves insertion of a small needle under local     anesthetic.   "
20687|NCT03014778|"     This study is necessary in order to provide proof the effectiveness of Chlorhexidine     gluconate and its safety.   "
20688|NCT03014765|"     Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated     dilatation capability (FMD) of the brachial artery will be measured prior to elective     surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the     brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after     cuff deflation. From above mentioned values the increase in the diameter of the artery during     reactive hyperemia will be calculated.      Simultaneously with the ultrasound investigations, the blood for determination of the     endothelial dysfunction markers will be collected.      The participants will be contacted again 3 months after the surgery and asked about the     complications which may be associated with the surgery.   "
20689|NCT03014752|"     Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the     primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and     other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a     low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to     compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins     diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients     in each group, and will receive the diet for three months on non-randomised basis. In the     classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each     gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be     established on outpatient setting, without fasting and gradually. The modified Atkins diet     will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of     carbohydrate plus protein.   "
20690|NCT03014739|"     Achilles tendon plays a significant role in walking and sporting activities, particularly     through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line     examination of choice for patients suspected of having Achilles tendon injury, which is more     and more frequent. Nowadays, ultrasound elastography can be used to evaluate the     viscoelasticity properties of Achilles tendon, however little is known about the     reproducibility of the technique. This study aims to evaluate the reproducibility of     supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in     Achilles tendon and plantar fascia.   "
20691|NCT03014726|"     Robust I study is a feasibility study about safety and efficacy of DCB.   "
20692|NCT03014713|"     The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive     analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled     Analgesia (PCA) after open colorectal surgery.   "
20693|NCT03014700|"     One of the most common hemostatic derangements in pediatric open- heart surgery is an acute     acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet     aggregation, resulting in increased bleeding and allogenic blood transfusions.      Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in     pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen     concentrate will be as effective in treating post-CPB bleeding and will decrease total blood     product exposure when used as part of a blood transfusion algorithm.      We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a     fibrinogen level <250mg/dL while on bypass.      We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard     of care in the management of peri- operative bleeding in neonatal patients undergoing     cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as     effective as the standard of care, then we would plan a multi-center trial to demonstrate the     safety and efficacy of this medication. If we are able to demonstrate that fibrinogen     concentrate is effective, fibrinogen concentrate could replace allogenic products and     potentially decrease transfusion related morbidity in mortality in this population.   "
20694|NCT03014687|"     To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for     pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection     (sinusitis), and helps mucosal healing in the nasal passages.   "
20709|NCT03014492|"     The purpose of the study is to monitor longitudinal changes in brain structure and function     between the preseason and postseason, in a population of soccer playing athletes wearing the     Device and compared to a similar population not wearing the device. Secondly, the purpose is     to determine the protection of the device relative to amount and magnitude of sustained head     impacts.   "
20710|NCT03014479|"     The purpose of this study is to assess the reduction in treatment burden during 12 weeks of     trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy     only.   "
20695|NCT03014674|"     Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb)     that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor     complex expressed on the eosinophil cell surface and thus inhibits signaling. This study will     compare the pharmacokinetics and safety of mepolizumab administered as a liquid drug product     in two different devices with the reconstituted lyophilized drug product in healthy subjects.     Subjects will receive a single administration of 100 milligram (mg) mepolizumab as a single     injection. The randomization will be stratified by body weight (<70 kilogram (kg), 70 <80 kg     and >=80 kg) and the site of injection will be randomized 1:1:1 to the upper arm, abdomen or     thigh. Approximately 243 healthy subjects will be randomized so that at least 9 subjects are     randomized to each mepolizumab treatment within each weight strata and 3 subjects within each     mepolizumab treatment, weight strata and injection site. Each subject will participate in the     study for up to approximately 16 weeks (up to 85 days after drug administration), and will     have a screening visit, a single dose treatment period, and a follow-up visit.   "
20696|NCT03014661|"     Questionnaire to measure and control the quality of life of patients with hay fever who are     treated or were treated with Pollinex quattro   "
20697|NCT03014648|"     This is a phase II clinical trial aimed at evaluating the efficacy of PD-L1 inhibition with     atezolizumab in advanced squamous and non-squamous NSCLC patients previously treated with     anti-PD-1 therapy with either nivolumab or pembrolizumab.      In order to account for the variability of response kinetics to PD-1 directed therapy,     patients will be enrolled in 3 parallel cohorts based on the best overall response to PD-1     directed therapy.        -  Cohort 1 (progressive disease)        -  Cohort 2 (stable disease with minimum 12 weeks of therapy)        -  Cohort 3 (partial to complete response followed by progressive disease)   "
20698|NCT03014635|"     This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to     severe frown lines.   "
20699|NCT03014622|"     This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to     severe frown lines.   "
20700|NCT03014609|"     The principal objective of the study is to measure parameters of inflammation, oxidative     stress, and vascular, respiratory, and peripheral muscle function parameters, and identify     parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using     multivariate analysis.   "
20701|NCT03014596|"     Procedures for systematic user involvement in primary mental health services are lacking, and     several adolescents are dissatisfied with their opportunities to influence the service     provided. The research on the effects of user involvement is scarce, especially regarding     user involvement for children and adolescents. Hence, we suggest introducing an idiographic     assessment tool in a selection of Norwegian primary mental health services. Idiographic     assessment is a way of measuring psychological constructs, by using tools specifically     adapted for each individual respondent.      This protocol describes the implementation and evaluation of a user involvement tool called     'Assert', in Norwegian primary mental health services. Assert is a simple tool where the     adolescents themselves decide the goals or themes that they would like to address in     collaboration with their service provider. Assert is scored each time the adolescent and the     service provider meet, to monitor progress toward the goal. A randomised controlled trial     design is proposed for this study. Assert will be implemented in 5-10 Norwegian     municipalities, and will include 250 participants between 12 and 23 years. The objective of     the study is to examine the relationship between Assert and perceived user involvement. Are     idiographic measures an adequate way to operationalise user involvement on an individual     level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and     mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and     goals will be conducted to explore what matters to the adolescents that visit primary mental     health services in Norwegian municipalities.   "
20702|NCT03014583|"     Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly     labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a     spine surgery. Treatment of this chronic condition by further operation or medical management     has a heavy financial impact on health care systems.      Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation     (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to     be a clinically effective adjunct to medical management. SCS has the advantages of being     reversible and less invasive than surgery and may cause fewer issues over time than long-term     pharmacological treatments.      Despite variable levels of success in the literature, approximately 30-55% of the patients     treated with traditional SCS for neuropathic pain disorders will not receive adequate long     term pain relief. Therefore, technical SCS system refinements, as well as new techniques have     emerged.      Two new stimulation waveforms based on traditional SCS technology have appeared to further     optimize the outcome for specific painful conditions;        -  Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz          per burst and pulse width and interspike intervals of 1 ms.        -  High-frequency stimulation (from 1 to 10 kHz) mode.      Several studies have demonstrated the potential interest of these 2 new waveforms to treat     FBSS patients compared to traditional SCS.      The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of     waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High     Frequency stimulation (HF)).      To date, literature data comparing these 3 stimulation patterns is lacking but it is     suggested the pain relief in some of non-responsive patients can be recaptured by     increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It     seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to     compare the effects of these 3 different SCS modalities in FBSS patients and to determine     which concept is the most effective in terms of pain reduction and energy consumption.   "
20703|NCT03014570|"     This pragmatic trial focuses on implementation of an evidence based process to increase     person-centered management of behavioral and psychological symptoms of dementia (BPSD) in     nursing homes, referred to as EIT-4-BPSD. The findings from this study will add to what is     known about implementation of effective interventions in nursing homes, will serve as a model     for other programs and care approaches, and will help facilities and staff implement quality     person-centered care, which is the goal of the National Partnership to Improve Dementia Care     and Reduce Antipsychotic Use in Nursing Homes.   "
20705|NCT03014544|"     The purpose of this study is to compare the psychometric properties (performance validity) of     8 individual cognitive tests in a computer-administered cognitive test battery intended for     the assessment of cognitive function in participants with major depressive disorder (MDD)     either in partial or full remission against 8 corresponding standard, non-reference,     examiner‑administered cognitive tests.   "
20711|NCT03014466|"     Preoperative anxiety in pediatric patients undergoing surgical procedures has been previously     shown to increase the likelihood of family stressors, post- operative pain, agitation, sleep     disturbances, and negative behavioral changes. The purpose of this study is to use a     non-invasive device to determine whether a bed mounted Video Projection unit (i.e. BERT,     Bedside EnterRtainment Theater) is more effective than the standard of care tablet (i.e.,     iPad) for preventing anxiety before surgery among children undergoing anesthesia and surgery.     The anticipated primary outcome will be reduction of child's anxiety in the preoperative and     operating room setting and compliance with mask induction.   "
20712|NCT03014453|"     Bronchopulmonary dysplasia(BPD) is a common condition in the low birth weight     infants.Although most of the BPD symptoms improved after a regular treatment in infancy,     there are still a few late complications left such as the frequent respiratory symptoms, a     slower weight gain and even sudden death. These late complications have made so much trouble     to the healthcare of BPD infants.How to find the risk factors and to reduce the prevalence of     these late symptoms becomes necessary. It has been reported that gastroesophageal     reflux(GER)is a long-lasting form in the extremely premature infants with BPD,however,whether     it serves as a potential risk for the late complications is still unclear.In this study, a     cohort of BPD infants was observed with the late complications obtained by a monthly followed     up for 12 months after discharge, the prevalence and risk factors were analyzed by Cox's     proportional hazards regression model.As one of the risk factors, GER was verified whether to     play a critical role in these late complications.   "
20713|NCT03014440|"     The purpose of this study is to determine if cannabidiol is safe and effective at different     doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has     potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure     frequency. There are only a few open label studies that have demonstrated the safety and     tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies     were performed either retrospectively or with varying cannabidiol preparations. There are no     well-documented studies and completely analyzed data for pediatric epileptic patients.   "
20714|NCT03014427|"     The storage and use of biomaterial samples is an important requirement for accompanying     research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is     explicitly recommended in official guidelines. In order to preserve the biomaterial, the     patient must consent to the removal, transfer and storage of the biomaterial separately from     the consent to the register. The biomaterial is taken at times at which a blood or urine     sampling takes place anyway in the clinical routine. Therefore no additional interventions     are necessary.   "
20715|NCT03014414|"     People with elevated blood pressure are at higher risk of having a heart attack or stroke     than people with lower blood pressure. Losing a modest amount of weight—such as 15 or 20     pounds—can reduce the risk of having a heart attack or stroke. However, it can often be a     struggle to maintain weight loss over time.      This study examines whether two behavioral weight-management programs can help people     maintain weight loss over time. In this study, 346 adults will be randomly assigned (like     flipping a coin) to one of the 12-month programs and followed for 36 months (i.e., 3 years)     to see how their body weight may change.   "
20716|NCT03014401|"     The purpose of this study is to compare the clinical and functional outcomes of patients with     mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:        1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with          standard arthroscopic treatment consisting of: partial meniscectomy, cartilage          stabilization, loose body removal and selective synovectomy.        2. Standard arthroscopic treatment (above) with out cell transplant.   "
20717|NCT03014388|"     Using growth factors obtained from patient's venous blood mixed with particulate autogenous     bone the study compares bone gain by implant with gold standards in sinus Lift procedures for     future implant insertion.   "
20718|NCT03014375|"     The purpose of this study is to:      To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and     faeces   "
20719|NCT03014362|"     The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation     (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a     treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with     fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and     medication therapies. There will be 6 months of follow-up, in order to establish the ongoing     and lasting therapeutic effect of TMS.   "
20720|NCT03014349|"     The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann     applanation apparatus and pneumatic in the water drinking test.   "
20721|NCT03014336|"     The drawbacks of chemical CO2 absorbers include the production of compounds harmful to     patients that also lead into increased cost and environmental impact, as well as the daily     disposal of compound special waste. Sustainable management of general anesthesia is a growing     concern. Continually diluting anesthetic circuits, and the disposal of chemical granulate are     serious environmental problems.   "
20722|NCT03014323|"     Investigators will test the hypothesis that chronic restoration of vagal nerve activity with     a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose     tissue oxidation in obese African American Women compared to white women.   "
20731|NCT03014206|"     This study aims to understand the following items in post-marketing actual clinical settings     to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65     years or older).        1. To confirm the use in actual clinical settings        2. To confirm the occurrence of adverse events   "
20732|NCT03014193|"     This study evaluates the usability of the multilevel pregnancy test among women undergoing     medical abortion.   "
20733|NCT03014180|"     The purpose of the LEVEA study is to assess the performances of a new automatic left     ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by     physicians during in-hospital follow-up.   "
20744|NCT03014037|"     Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects     nearly 27 million people in the United States. This disease leads to the breakdown of the     cartilage surfaces of the joints, which serve as the connection points between the bones of     the body, causing a large amount of pain and disability in patients. Increasing the number of     available treatment options for osteoarthritis is becoming increasingly more important as     Americans continue to age. Using stem cells taken from bone marrow is one of the     non-operative treatments that has been gaining popularity in the recent past. This study aims     to clarify how this procedure should best be done by comparing stem cell concentrations and     patient outcomes (short and long term) in patients who have stem cells taken from one area vs     two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).   "
20745|NCT03014024|"     Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks.     After removing the cast, it is common to still have pain, swelling and reduced mobility in     the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.   "
20723|NCT03014310|"     This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the     safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus     vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or     without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150 (up to     380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good health and     meet all eligibility criteria. The entire study duration is approximately 24 months and each     subject participation duration is approximately 13 months. The primary objectives are: 1) To     assess the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus     vaccine following receipt of two doses administered intramuscularly at different dosages     (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately     21 days apart. 2) To assess the serum HAI and Neut antibody responses to a monovalent     inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered     intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without     AS03 or MF59 adjuvants approximately 21 days apart.   "
20724|NCT03014297|"     This is a single center, open label, phase I study involving grade I-III     gastroenteropancreatic neuroendocrine tumors, consisting of a dose escalation Part A followed     by an expansion cohort Part B. On Part A Patients will be treated with daily oral everolimus.     Fosbretabulin will be administered IV either q3 weekly or q weekly based on PO CRM cohort.     Part B: Once the investigators have established an MTD in Part A, the investigators will be     treating 15 more patients at that dose combination. The primary and secondary objectives of     the expansion cohort will be similar to Part A of the study, i.e., to establish a safety     profile of the experimental drug combination and to collect and assess efficacy data.     Patients will be treated with concurrent everolimus and fosbretabulin for 12 weeks.   "
20725|NCT03014284|"     This is a simple tissue collection study with no therapeutic intent. Colon tissues will be     taken from standard of care procedures. Tissues will be tested for their functions,     expression of immune co-signaling molecules and reactions to transduction with recombinant     Listeria vectors to assess effects on expression of B7-H1 and cytokines.   "
20726|NCT03014271|"     Sources of Strength is an evidence based program for youth suicide that trains student key     leaders to strengthen social connectedness and healthy norms school-wide and is listed on the     National Registry of Evidence Based Programs and Practices (NREPP). This project will expand     the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in     a randomized controlled trial (RCT) in twenty-four high schools.   "
20727|NCT03014258|"     This is a phase I study that will assess the acquisition of immunity to Pf malaria over the     course of 4 sequential Controlled Human Malaria Infections (CHMI) over 3 years, in 10 healthy     adult participants. The study is expected to last for 48 months and will include 28 healthy     male and female volunteers (10 study volunteers and 18 naïve controls to confirm Pf     infectivity during the 2nd -4th CHMI challenges) ages18 to 45 years, inclusive, from the     greater Baltimore community.      The primary objective of this study is to determine whether protective immunity against     parasite infection develops following repeat CHMI.   "
20728|NCT03014245|"     Melatonin is well known for its role in the sleep-wake cycle but it is less well known as an     effective antioxidant. It has been reported to be synthesised in the placenta and may have     both receptor mediated and non-receptor mediated protective functions during pregnancy.     Severe pre-eclampsia has been reported to be associated with low levels of melatonin in the     placenta although it is not known if the placental melatonin contributes to circulating     levels. There is little reported on the circulating levels of melatonin or oxidative stress     at different stages of normal pregnancy. More information on the role of melatonin and     metabolism of melatonin in pregnancy as well as any significant association with adverse     pregnancy outcomes would inform planning of larger research studies to investigate the     potential role for melatonin as a biomarker for obstetric disease and potentially as a     therapeutic agent in future.      This observational pilot study aims to measure serum melatonin levels and 6-hydroxymelatonin     sulphate (the major metabolite of melatonin) during each trimester of pregnancy.   "
20729|NCT03014232|"     Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high     mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial     was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal     including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f     between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).   "
20730|NCT03014219|"     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer     using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20     million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be     enrolled.      Subjects will undergo standard adjuvant therapy including drainage of infection and placement     of a draining seton. Six weeks post placement of the draining seton, the seton will be     replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects     will be subsequently followed for fistula response and closure for 24 months. This is an     autologous product derived from the patient and used only for the same patient.   "
20832|NCT03012893|"     To determine the accuracy of two techniques (transverse scan and sagittal scan) using     ultrasonography to identify C7 spinous process compare to the fluoroscope (standard     technique)   "
20746|NCT03014011|"     Hypoglycaemia in subjects suffering from type 2 diabetes may have substantial consequences     including a significant negative impact on quality of life. Further, repeated minor     hypoglycaemias may result in significant productivity losses.      Here, the investigators propose to provide quantitative results on cognition during an acute     mild hypoglycaemic episode (target plasma glucose 3 mmol/L) in 28 subjects with type 2     diabetes. Data will be provided on executive function, attention and memory.   "
20734|NCT03014167|"     Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH     guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted     populations, including pre-school age children and school-age children. However mathematical     models suggests that current MDA strategies are not sufficient for interrupting disease     transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have     successfully treated entire populations with albendazole (in combination with ivermectin or     diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project     will conduct a series of community-based cluster randomized trials in India, Malawi, and     Benin to determine if maintaining three years of MDA with albendazole to entire communities     following the cessation of LF programs can interrupt STH transmission in focal geographic     areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus     targeted MDA of children in interrupting the transmission of STH. Nested implementation     science research will be used to optimize the intervention, identify contextual factors     influencing trial efficacy, and evaluate the feasibility of sustaining and scaling     community-wide MDA for STH. These data will provide evidence necessary to inform future     guidelines, policies, and operational plans as country partners engage in intensified     approaches to eliminate these disabling diseases.   "
20735|NCT03014154|"     Asthma is a chronic inflammatory disease of the Airways of recurring character. The     obstruction to the airflow carries the short-and long-term consequences that require     prophylactic interventions and in emergency many times. The children due to immaturity of the     respiratory system associated with the use of steroids suffer structural consequences, as for     example, the physical deconditioning that intensifies the symptoms of the disease and affects     negatively on the quality of life. Therefore, to set up a physical training program suitable     for the paediatric population, using resources to increase adherence to the regular practice     of exercises, can be the difference for the reduction of the number of exacerbations, the     sensation of Dyspnea and the doses of medication, positively impacting the clinical picture     of child asthmatic. The investigators conducted a randomized, blinded in order to evaluate     the effects of training with active video game associated with resisted exercise the exercise     in inflammatory and functional outcomes resisted in asthmatic children.   "
20736|NCT03014141|"     The consumption of oat bran fiber also has a significant bulking effect in humans. However,     besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the     purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan)     supplementation on bowel function and appetite.   "
20737|NCT03014128|"     Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to     many occupational situations and specific industries. However, there is conflicting     information about monotonous and repetitive activities. In this context, the profession of     surgical device mechanics has not been analyzed so far.      The objective of this study is to examine surgical device mechanics at different workplaces     with varying work contents and to compare them with a control group without the repetitive     workload exposition as described above. The headquarters and main production site of Aesculap     are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical     devices.      After statistical power analysis, the investigators plan to randomize and include a total of     90 voluntary test persons in 3 groups (30 persons each). The study will include standardized     questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test).      Primary and secondary endpoints were defined to show if significant difference between     surgical device mechanics and a control group is present.   "
20738|NCT03014115|"     The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in     infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6     months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates,     immune markers) and safety information in these 12-18 month old infants.   "
20739|NCT03014102|"     The purpose of this study is to determine whether recombinant human thrombopoietin are     effective in peripheral blood progenitor cells mobilization for autologous transplantation.   "
20740|NCT03014089|"     The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in     healthy adult subjects.   "
20741|NCT03014076|"     The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2     peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment     of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a     primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the     study are the following:        -  Assess safety and document local and systemic toxicity to combination immunotherapy with          GP2 peptide + GM-CSF vaccine and trastuzumab        -  Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of          GP2 peptide + GM-CSF vaccine and trastuzumab        -  Determine maximum tolerated dose and optimal biologic dose for the combination          immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab   "
20742|NCT03014063|"     This is a prospective observational cohort trial evaluating a single plasma vasopressin     concentration in patients receiving exogenous, adjunctive vasopressin for septic shock. The     trial is designed to determine whether plasma vasopressin concentration influences the     likelihood of hemodynamic response to exogenous vasopressin therapy.   "
20743|NCT03014050|"     Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction     and non-motor symptoms. Here, we propose to examine whether Bio Electro Stimulation Therapy     (B.E.S.T.) with a small, non-invasive, handheld electronic device designed to apply micro     current stimulation to a person's hand can ameliorate some of the symptoms of PD.   "
20847|NCT03012698|"     The current study aims to test the safety of Repeated Magnetic Stimulation (RMS) treatment     for dry eye. Patients will be asked to undergo a one-time treatment with Epitech Corneal     Magnetic Stimulation Device on one eye. Changes will be monitor for over a study period of 3     months.   "
20747|NCT03013998|"     This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic     screening followed by assigning and accruing simultaneously to a multi-study Master Protocol     (BMAL-16-001-M1). The specific subtype of acute myeloid leukemia will determine which     sub-study, within this protocol, a participant will be assigned to evaluate investigational     therapies or combinations with the ultimate goal of advancing new targeted therapies for     approval. The study also includes a marker negative sub-study which will include all screened     patients not eligible for any of the biomarker-driven sub-studies.   "
40860|NCT02750787|"     The study is designed to observe the use of a peptide-based oral nutrition supplement in     adults with chronic malabsorption or maldigestion who require supplemental nutrition as     assessed by a clinician.   "
20749|NCT03013972|"     Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients die     from colorectal cancer each year. The third leading cause of death is colorectal cancer in     Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy     and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence.     However, disease and treatment-related toxicities in cancer patients may result in fatigue     and interfered quality of life (QoL). Previous studies have reported that cancer-related     fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases, it     can occur during treatment, in advanced disease and in disease-free survivors; the prevalence     of fatigue is reported to be between 59-96% in patients undergoing chemotherapy, 65-100% in     patients receiving radiation therapy, and 30% in long term survivors. Also, CRF has been     reported as the most frequent and distressing toxicity of colon and rectal chemotherapy. The     National Comprehensive Cancer Network (NCCN) has published guidelines for the definition of     CRF as ''a persistent subjective sense of physical, emotional, and/or cognitive tiredness or     exhaustion related to cancer or cancer treatment that is not proportional to recent activity     and that significantly interferes with usual functioning. Besides, CRF could dynamically     change with the interactions among disease progression, treatment regimen, tumor site,     nutrition, infection or other factors. Therefore, to minimize the impact of CRF on cancer     patients, more in-depth researches on CRF are needed.      The aim of this longitudinal study is to examine the dynamic changes, correlated factors and     QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the     results will supply physicians with more understanding about CRF, and help them to enhance     the quality on cancer care to being perfected in the future.   "
20750|NCT03013959|"     As is reported, NSAIDs(pranoprofen ,bromfenac) eye drops can suppress herpes simplex     virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical,     there is no risk of corneal tissue melting, glaucoma, cataract by topical application of     NSAIDs. To explore more effective clinical treatment of viral keratitis patients to control     the inflammatory damage, save the visual function and reduce the recurrence of the virus ,we     observe the effect of anti-inflammatory and inhibition of recurrence on the herpes simplex     virus after topical NSAIDs administration.   "
20751|NCT03013946|"     The primary objective of the trial is to determine the effect of a 24-week concomitant     coaching on patient reported outcomes of patients receiving standard treatment for mRCC with     sunitinib.   "
20752|NCT03013933|"     This phase I trial studies the side effects and best dose of brentuximab vedotin and     cyclosporine when given together with verapamil in treating patients with Hodgkin lymphoma     that has come back or does not respond to treatment. Monoclonal antibodies, such as     brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread.     Immunosuppressive therapies, such as cyclosporine, may improve bone marrow function and     increase blood cell counts. Verapamil may increase the effectiveness of brentuximab vedotin     by overcoming drug resistance of the cancer cells. Giving brentuximab vedotin, cyclosporine,     and verapamil may work better in treating patients with Hodgkin lymphoma.   "
20753|NCT03013920|"     Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary     tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion     and to collect tissue for histopathology. These techniques are considered to be the gold     standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in     combination with endo-urological procedures, seems promising to improve diagnosis of     urothelial cancer. CLE image characteristics for UTUC still have to be defined.      Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess     in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial     carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively     comparing CLE images with both histopathology from diagnostic biopsies and pathology from the     therapeutic radical nephroureterectomy. Secondary objectives are the development of an     imaging atlas and to assess the technical feasibility and procedure related adverse events of     CLE.   "
20754|NCT03013907|"     The purpose of this study is to adapt and then evaluate the feasibility, acceptability, and     efficacy of a telephone-based intervention (UPLIFT: Using Practice and Learning to Increase     Favorable Thoughts) for individuals with elevated depressive symptoms and hypertension.     UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1 hour/week     by phone.      Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual     interviews and to test the adapted UPLIFT program in a single-arm design. Aim 2 of this study     is a randomized controlled trial (RCT) that will compare the effects of the adapted UPLIFT     program to usual care (UC) and to test mediators and moderators of the effects of UPLIFT.   "
20755|NCT03013894|"     Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up     of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging     technique, that can be used combined with endo-urological procedures, seems promising to     improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal     laser endomicroscopy (CLE) still has to be defined.      Objective: To directly correlate CLE images with histopathology, and identify and define CLE     characteristics of normal urothelium, benign bladder urothelium, and bladder tumors     (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract.      Primary objective: to develop descriptive image interpretation criteria and a classification     of CLE images of bladder tissue through a review of prospectively obtained CLE videos from     bladder tissue correlated with histopathology.      Secondary objectives:        -  Assessing procedure related adverse events of CLE        -  Assessing technical feasibility of CLE        -  To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign,          low-grade or high-grade and CIS)   "
20756|NCT03013881|"     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of     escalating single-dose of UB-921 in healthy male volunteers.   "
23396|NCT02979392|"     The purpose of this study is to investigate the safety and to determine maximum tolerated     dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)     in patients with advanced solid tumor.   "
20757|NCT03013868|"     Despite the growing public awareness and recent progress in multimodality therapy to the     colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly     cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant     metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated     with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to     prevent the development of metastasis. Early detection and characterization of CTCs is     therefore important as a potential strategy to monitor the progression of CRC. The current     proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R     system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.   "
21108|NCT03009292|"     Study E7080-C086-108 is an open-label, single- and multiple-dose pharmacokinetic (PK) study     of lenvatinib (administered orally, once a day [QD]) in Chinese participants with solid     tumor. A total of 12 participants will be enrolled to evaluate the PK of 24 milligrams (mg)     QD dosing of lenvatinib.   "
20758|NCT03013855|"     This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for     the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in     pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for     spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition,     some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE.     This study aims to assess the correlation between FIT using the stool sample from DRE     (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators     may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help     avoid logistical barriers, as well as improve compliance and adherence to colon cancer     screening in the outpatient setting, eventually leading to improved quality of care.   "
20759|NCT03013842|"     Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human     subjects, in order to obtain fetal heart rate.      We want to determine if this device can accurately measure a baby's oxygen level when placed     on your abdomen.      Current technology to measure a baby's oxygen levels requires a probe to be inserted into the     vagina.   "
20760|NCT03013829|"     The purpose of this study is to evaluate the effectiveness of a targeted educational approach     designed to increase knowledge about the risks and benefits of living donation generally and     KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns,     and facilitate informed decision making about KPD among incompatible or cross-match positive     donor-recipient pairs.   "
20761|NCT03013816|"     The objective of this study is to evaluate the effectiveness of targeted video interventions     designed to increase organ donation knowledge, intentions, and designations among adolescents     enrolled in driver's education classes, as well as to increase the commitment of     parents/legal guardians to authorize organ donation in the event of their adolescent's death.     The central hypothesis is that integrating donation education into the driver's education     curriculum will increase knowledge and attitudes that facilitate the behavioral action of     donor designation at the time of getting a new driver's license.   "
20762|NCT03013803|"     Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study     is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to     show that it is acceptable for patients in the United Kingdom.   "
20763|NCT03013790|"     The investigators are studying the use of Melatonin in non-ventilated patients over the age     of 65. Primary endpoint will be assesments of delirium, with secondary endpoints to include     length of stay, use of anti-psychotic medications, and mortality   "
20764|NCT03013777|"     To determine the effect of cognitive behavioral therapy (CBT) in the severity of anxiety and     depression in adult patients with familial dysautonomia. Patients will be enrolled in an     8-week CBT program. All CBT sessions will be done either in person at the NYU Dysautonomia     Center or over the phone to help accommodate disability and potential physical limitations of     our patient population.   "
20765|NCT03013764|"     Physical inactivity results in reductions in glucose tolerance and less sensitivity to     insulin. If this inactivity lasts long enough it can result in insulin resistance and type 2     diabetes. A high protein diet can reduce elevated glucose levels in individuals with type 2     diabetes. Thus the investigators are interested in establishing if during a period of     inactivity if a diet modification can minimize the glucose changes normally observed with     inactivity. The objective of this project is to determine if short-term high protein (HP)     feeding protects against the changes in glucose levels normally observed with physical     inactivity. The investigators will also examine measures of blood vessel function, blood     lipid and blood pressure.      Twelve subjects will complete two 10 day study periods of reduced physical activity and will     be studied before and after each of these study periods. For their testing subjects will have     the following measurements: postprandial glucose responses to a mixed meal, 24 h free living     blood pressure control during acute physical inactivity, blood lipids, changes in body     composition, changes in circadian rhythm using skin temperature (ibutton), measurement of     aerobic capacity (VO2 max), blood vessel responsiveness (flow mediated dilation -FMD) and     changes in free living glucose levels (continuous glucose monitoring system (CGMS). Subjects     will complete two conditions (high protein -HP vs normal protein - NP diets) in a randomized     cross-over design. In the inactive phase subjects will reduce there steps to &lt;5,000     steps/d while consuming either a HP or NP diet. Completion of the study will take 8-10 weeks.   "
20766|NCT03013751|"     This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III     clinical trial to provide safety information regarding the long-term use of udenafil in     adolescents with single ventricle congenital heart disease.   "
20767|NCT03013738|"     This randomized controlled trial aimed to assess the efficacy of a 40-session     cognitive-behavioral group program, Growing Pro-Social (GPS), in reducing early maladaptive     schemas and cognitive distortions (primary outcomes), as well as anger, shame and paranoia     (secondary outcomes). The GPS's impact on behavioral change (e.g., in the reduction of     disciplinary incidents and prison records) was also tested, in order to ascertain if changes     observed in cognitive and emotional variables were reflected in a more adjusted behavioral     pattern. Personality Disorders were also tested as moderators of treatment effects.   "
20768|NCT03013725|"     The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in     1997-99 (HUSK). Both surveys were conducted as a joint project between the University of     Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of     Public Health) and the Municipal Health Service in Hordaland.      The main focus of the studies is on chronic diseases including cardiovascular disease,     cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors,     occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug     use. The main purpose of the surveys is to gather information so that disease ultimately can     be prevented.      Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000 in     1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93     survey also participated in 1997-99.   "
20769|NCT03013712|"     The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T     Cells infusion for EpCAM positive Cancer.   "
21109|NCT03009279|"     To investigate the association between metabolic syndrome (MS) and thyroid nodule(s).   "
20771|NCT03013686|"     The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic     appendectomy with follow-up MRI in patients with initially successfully treated     periappendicular abscess.      Periappendicular abscess is generally initially treated conservatively with antibiotic     therapy and if necessary, drainage. Operative treatment in the acute abscess phase is     associated with increased morbidity and thus complicated appendicitis with a periappendicular     abscess is initially treated conservatively. However, there is debate on whether interval     appendectomy is required.      After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular     abscess, patients enrolled in the PeriAPPAC study are randomised either to interval     appendectomy or to follow-up with MRI at two months after the initial treatment. All patients     also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the     MRI (outpatient visit at endoscopy unit with information on the MRI).      The primary endpoint is the treatment success in both treatment arms. In the interval     appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up     treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year     follow-up.      The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku     University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University     Hospital and Jyvaskyla Central Hospital.   "
20772|NCT03013673|"     In this cohort study, the investigators will study the asymptomatic period preceding the     onset of active Visceral Leishmaniasis (VL) in HIV‐infected individuals from VL endemic     regions in Ethiopia as an avenue to develop an evidence‐based screen and treat strategy to     prevent progression to active VL.   "
20773|NCT03013660|"     Preterm birth is the leading contributor to mortality among children younger than 5 years.     One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the     mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few     hours, ideally every day. This intervention can make breastfeeding easier and can improve the     health and development of the baby.      Unfortunately, despite the large health benefits, mothers in low-resource communities are     often unable to practice STSC due to a range of institutional and economic barriers. STSC     requires substantial time and financial commitments from mothers; they must travel from home     each day to the hospital to engage in STSC and provide expressed breast milk. Low-income     women with access only to limited federally provided unpaid family leave may have to choose     between returning to work while their baby is in the NICU and being able to stay at home with     their newborn after discharge from the NICU. Families of preterm infants also face direct     financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare     for older children).      This trial aims to examine the impact of providing additional support to low-income mothers     of babies born preterm in 2 hospitals in Massachusetts to help them provide STSC. Half of the     participants will be randomized to receive an additional financial support intervention while     their infant is in the NICU. The study will examine how this intervention impacts mothers'     health behavior while their child is in the NICU and up to three months after.      Most of the current and past policy efforts to increase STSC have focused on the delivery of     STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and     informed staff. However, interventions that focus exclusively on hospitals are unlikely to be     sufficient for low-income women if there are significant opportunity costs or transportation     costs to simply being present at the hospital. This study aims to provide more evidence to     determine whether removing these financial barriers has the potential to mitigate the poor     outcomes of preterm babies born to lower socioeconomic status households.   "
20774|NCT03013647|"     Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and     will be treated with Daylight Photodynamic therapy.      Before and after skin biopsies will be performed, for histological and immunohistochemical     analysis.   "
20775|NCT03013634|"     The purpose of this study was to evaluate the protective effect of dexmedetomidine on     myocardial injury during liver transplantation   "
20776|NCT03013621|"     Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery,     and is a major risk factor for mortality in this context.      The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common     complication, close to 100% if one takes into account the transient dysfunction.      A recent study showed that right ventricular dysfunction and the IRA seemed related, rather     on the slope of venous congestion. We wish to study this phenomenon more specifically in     particular to offer reliable diagnostic markers of venous congestion.   "
20777|NCT03013608|"     Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries.     The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The     empirical reparation technique is the nail bed suture and the relocation of the nail plate.     However, some authors think that suture the nail bed could increase the traumatism of the     nail bed because of the needle, the crush by the clamps and by the stitches too tight     (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat     the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed.     Advantages of this technique, claimed by the author, was time saving, with an aesthetical     result as same as the treatment with suture of the nail bed. A same study validated the     technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not     necessary to suture the nail bed. But, in our practice, the investigators noted complications     not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the     nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is     difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple     relocation of the nail plate in nail bed injuries in paediatric population is enough to have     good to excellent aesthetical results, with less complications and a lower cost, than the     other techniques. The aim of this study is to assess the aesthetical results 3 months after     simple relocation of the nail plate for nail bed injuries in children.   "
20778|NCT03013595|"     This study evaluates the longitudinal health and social outcomes of adolescent mental health     service users who are at the transition boundary of their child and adolescent mental health     service, and whether the implementation of a model of managed transition at the service     boundary benefits them, as compared to usual care.   "
20779|NCT03013582|"     Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand     therapists alike. Despite their commonality, no consensus exists as to the best means of     preventing adhesions, or the most ideal methods to treat them once they have occurred. The     purpose of this study is to compare patient outcomes after standard operative tenolysis     performed for adhesions of the hand to outcomes after tenolysis with the use of allograft     human amniotic membrane.   "
20780|NCT03013569|"     This is a pilot feasibility study for a new application of an approved fetal heart rate     monitoring device system. The objective of this study is to validate the feasibility of     acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the     routinely used scalp fetal heart rate (FHR) monitor.   "
20783|NCT03013530|"     A new law about the advance directives (AD) has been recently voted in France on February 2,     2016. This  Claeys-Leonetti  law has made the AD more binding, as in other countries. This     should lead to a greater respect of the human autonomy principle. However, the interpretation     of these guidelines is often difficult and may differ between doctors. Indeed, the     subjectivity of these interpretations could lead to different medical decisions by     physicians.      The investigators intend to assess the effect of advance directives (AD) on decision making     in care by intensivists, using a simulated (hypothetical) situation.   "
20784|NCT03013517|"     This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects     will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2     additional years if previously on active treatment in the PEPITES study, or for 3 years if     previously on placebo in the PEPITES study.   "
20785|NCT03013504|"     In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product     Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in     terms of efficacy, safety and pharmacokinetics.   "
20786|NCT03013491|"     The purpose of this first-in-human study of CX-072 is to characterize the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072     administered intravenously (IV) as a single agent or in combination with ipilimumab or     vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas.     PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial      CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1).     Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the     therapeutic index by minimizing drug interaction with normal tissue while retaining     anti-tumor activity. Probody therapeutics are masked to attenuate binding to target in     healthy tissue but can become unmasked in the tumor microenvironment by tumor-specific     protease activity.      PROBODY is a trademark of CytomX Therapeutics, Inc.   "
20787|NCT03013478|"     To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding     CBT4CBT to treatment as usual in a community based primary care program in a population of 60     individuals who meet current DSM criteria for substance use disorder other than nicotine.   "
20788|NCT03013465|"     The objectives of the study are 1) to determine the influence of daily consumption of     well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine     inflammatory marker changes consistent with decreased cancer risk.   "
20789|NCT03013452|"     In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI),     50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.   "
20790|NCT03013439|"     The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.   "
20791|NCT03013426|"     This Phase 1b study in adults with sickle cell disease (SCD) in steady-state (non-acutely     ill) aims to evaluate safety and toxicity of NVX-508 in a multi-dosing paradigm as well as to     determine the maximum tolerated dose (MTD) in this population. The information gained from     this study will be used in making decisions about the appropriate dose(s) and dosing schedule     in future multicenter studies of the efficacy of NVX-508 in the treatment of vaso-occlusive     episodes (VOE).   "
20792|NCT03013413|"     This clinical trial studies an ultrasound-based imaging procedure called elastography using     the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound     is a non-invasive imaging technique that uses high-frequency sound waves to produce images of     internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness     or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet     known whether elastography imaging using the Aixplorer system works better than standard     ultrasound imaging in detecting prostate cancer.   "
20793|NCT03013400|"     This study evaluates the effect of a 'lithium like' drug called ebselen (SP-1005) versus     placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder.     Half of the participants will receive ebselen and the other half placebo. The trial, will     last a total of four weeks.   "
20794|NCT03013387|"     This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with     somatostatin receptor positive tumors.   "
20795|NCT03013374|"     The adequacy of the quality of protein supply could influence the rate and the relative     composition of weight gain in very low birth weight preterm infants.      Aim of the study is to investigate protein balance according to feeding regimen and the     association between human milk feeding and fat free mass content at term corrected age in a     cohort of very low birth weight infants.   "
20796|NCT03013361|"     Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or     infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)     block, infraorbital nerve block and nasociliary block. As the current evidences regarding the     benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block     will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients     undergoing FESS under general anaesthesia in this study.   "
20797|NCT03013348|"     A retrospective validation study of a post-processing method intended to identify psychogenic     nonepileptic seizures   "
20798|NCT03013335|"     The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade     3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC     who have progressed during or after receiving at least one prior systemic anti-angiogenic     treatment and who are eligible for nivolumab monotherapy.   "
20812|NCT03013153|"     Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still     argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing     the inferior mesenteric artery (IMA), protection of autonomic nerve, low rectal anastomosis,     and total mesorectum excision. However, debate on the level of IMA ligation and debonding of     splenic flexure never ends. This study is going to give a clear and definite answer to how     and why surgeons should deal with the IMA in laparoscopy rectal surgery，base on the 3D     reconstruction of IMA and identification of IMA perfusion types.   "
20813|NCT03013140|"     Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in     caesarean section can effectively reduce the incidence of hypotension and fetal     complications.   "
20799|NCT03013322|"     Anticholium® per Se is a randomized, double-blind, placebo-controlled, monocentric trial to     assess whether the CAP can be transferred from bench to bedside. In this pilot study, 20     patients with perioperative sepsis and septic shock as a result of intra-abdominal infection     are enrolled. According to randomization, participants are treated with physostigmine     salicylate (verum group) or 0.9% sodium chloride (placebo group) for up to 5 days. The mean     Sequential Organ Failure Assessment (SOFA) score during treatment and subsequent intensive     care of up to 14 days is used as surrogate outcome (primary endpoint). Secondary outcome     measures include 30- and 90-day mortality. An embedded pharmacokinetics and pharmacodynamics     study investigates plasma concentrations of physostigmine and its metabolite eseroline.     Further analyses will contribute to the understanding of the role of various cytokines in the     pathophysiology of human sepsis. A computer-generated list is used for blocked randomization.   "
20800|NCT03013309|"     This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health     (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients     will be recruited based on their BMI as documented in the EHR and randomized to receive the     FCU4Health or Treatment as Usual.   "
20801|NCT03013296|"     Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.   "
20802|NCT03013283|"     Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway     Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are     delivered to the patient via an interface.      The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the     device. Because the comfort and degree of satisfaction of the patients to its interface is a     key factor of the observance, side-effects and satisfaction of patients need to be     continuously evaluated with available interfaces for CPAP and NIV treated patients.      The purpose of the research is the evaluation of interface side-effects and the degree of     satisfaction of home care patients treated for at least three months with CPAP or NIV.   "
20803|NCT03013270|"     This study investigates the effects of aerobic, resistance, inspiratory training modalities     outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming     for the 'optimum' (greek, αριστος=aristos) training program for HF patients.   "
20804|NCT03013257|"     Graves' disease (GD) is an autoimmune thyroid disorder caused by stimulating auto-antibodies     to the thyrotrophin (TSH) receptor on thyroid follicular cells. It is the most common cause     of hyperthyroidism and approximately 3% of women and 0.5% of men develop GD in their     lifetime.      RAI has been shown to be a cost-effective and safe therapy in patients with GD but with some     disadvantages. In addition, despite its proven efficacy and safety, many patients do not wish     to undergo RAI because of radiation fear and prefer to either continue ATDs or have surgery.      High-intensity focused ultrasound (HIFU) is a non-invasive procedure that involves the     application of a high-energy focused beam for thermal tissue ablation within a targeted zone.     Similar to the principle of RAI (i.e. using ionizing radiation to ablate thyroid parenchyma     and cause GD remission), we postulated that the heat energy generated from HIFU could also be     used to ablate the thyroid parenchyma and cause GD remission. The idea of using heat energy     to ablate thyroid parenchyma minimally invasively was recently reported using radiofrequency     ablation but to our knowledge, we are one of the first (if not the first) group to propose     using HIFU energy to ablate thyroid parenchyma as a definitive treatment for relapsed GD.      Having obtained ethical approval, a pilot study was conducted to examine the efficacy and     safety of HIFU as a treatment for relapsed GD. In the pilot study, all patients underwent a     safe and successful HIFU ablation for relapsed GD. Based on the results of the pilot study,     we hypothesize that a single HIFU treatment to the thyroid gland may be as effective as our     standard outpatient fixed-dose of RAI (370MBq) in causing remission of GD at 6-month. If our     hypothesis turns out to be true, HIFU could become a treatment option for patients who are     indicated for RAI but do not wish to have it because of one reason or another. HIFU appears     to induce a faster disease remission and lessen the need of deferring pregnancy and radiation     precautions because of the absence of radioactivity.   "
20805|NCT03013244|"     The purpose of the present study was to investigate the acceptability and efficacy of a     cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle     dysmorphia risk factors in men with body dissatisfaction. The investigators hypothesized that     the program would reduce eating disorder risk factors to a greater degree compared to wait     list control and that these effects would be maintained at 1 month follow-up.   "
20806|NCT03013231|"     Despite the large majority of patients that undergo ACL reconstruction reporting successful     outcomes in regard to tests of knee function, only about 2/3 return to their prior level or     athletic activity after surgery. A large amount of research has been conducted investigating     the effects of psychological factors on return to sports after ACL reconstruction; however,     the specific role of resilience has yet to be solely analyzed. This study aims to determine     the effect of variations in patient resilience on their return to sports after surgery.   "
20807|NCT03013218|"     A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and     lymphoma   "
20808|NCT03013205|"     Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with     the frozen shoulder. In this study, investigators will compare intra-articular steroid     injections with direct coracohumeral ligament steroid injection to conventional     intra-articular steroid injection. Investigators will measure the primary outcome as shoulder     function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral     ligament under elastogram.   "
20809|NCT03013192|"     Patients who are prescribed physical therapy exercises for their shoulder will have increased     compliance to their PT exercises, an increased PROMIS- Upper Extremity CAT score, and will     have increased range of motion (or reach maximum range of motion earlier) at the end of the 3     month EpxPhysicalTherapy intervention.   "
20810|NCT03013179|"     This project, the Intergenerational Blood Pressure Study, is a 5 year research study funded     by the National Institutes of Health/National Institute of Nursing Research and led by the     Yale University School of Nursing and The Consultation Center at the Yale University School     of Medicine, Department of Psychiatry in partnership with Head Start programs across CT. The     investigators seek to reduce hypertension health disparities among underserved Black/African     American children and their mothers by conducting community-based research to better     understand the genetic, psychological, and environmental factors that may contribute to high     blood pressure.   "
20811|NCT03013166|"     To describe clinical outcomes and both primary and secondary care health care resource use in     patients who have been prescribed either immediate-release (IR) hydrocortisone or     modified-release (MR) hydrocortisone or prednisolone in the UK.   "
20814|NCT03013127|"     This is a phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475)     in patients with osteosarcoma who have experienced disease relapse or progression after at     least one line of systemic treatment, and who are not eligible for curative surgery.   "
20815|NCT03013114|"     Primary immune thrombocytopenia (ITP) is a disorder caused by autoantibody-mediated platelet     destruction and decreased platelet production. It has been reported that refractory ITP is     closely related to long-lived plasma cells (PCs), which are resistant to glucocorticoids,     conventional immunosuppressive and cytotoxic drugs, irradiation and B-cell depletion     therapies.      Proteasome inhibition bortezomib is one of the most promising therapeutic approaches to     target PCs, since this strategy has been shown to efficiently eliminate multiple myeloma     cells, that is, transformed PCs. It also has been successfully used in SLE-like mice,     experimental autoimmune MG rats and experimental hemophilia-A mice that develop anti-factor     VIII antibodies in preclinical models by depleting both short-lived and long-lived PCs.     Additionally, treatment with bortezomib resulted in a rapid clinical response in a patient     with refractory thrombotic thrombocytopenic purpura associated with the depletion of     inhibitory autoantibodies against ADAMTS13, a metalloproteinase that cleaves the von     Wille-brand factor, which is produced by plasma cells. Hence, the elimination of autoreactive     PCs by proteasome inhibitors might represent a new treatment strategy for     autoantibody-mediated diseases.      To date, refractory ITP is lacking of effective treatments and these findings encouraged us     to conduct a study of bortezomib in management of ITP with high anti-platelet antibodies     level. Data from this study may provide some idea of bortezomib in the treatment of ITP.   "
20816|NCT03013101|"     This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody     JS001, as a monotherapy in patients with locally advanced or metastatic melanoma who have     failed in routine systemic treatment.   "
20817|NCT03013088|"     This is a clinical study aimed at demonstrating the safety and product performance of the     SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can     facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO) located in     the lower extremity arteries without major adverse events related to SoundBite device     utilization.   "
20818|NCT03013075|"     The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation     of stress response, decrease in pulmonary vascular resistance, myocardial protection and     positive myocardial oxygen balance will cause improvement in right ventricular function. So     far there is no study that has evaluated the effect of HSA anesthesia on the right     ventricular function, hence the investigator planned this study to compare the effect of HSA     on the right ventricular function in patients with mitral valve disease with moderate to     severe pulmonary hypertension planned for mitral valve replacement surgery.   "
20819|NCT03013062|"     Since the pulmonary artery hypertension is defined based on MPAP and the two previous     formulae relating MPAP and PAT were derived in western population, the investigator planned     to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian     population and compare the accuracy of all the three formulae   "
20820|NCT03013049|"     Vitiligo is a complex disease causing a selective, often progressive, loss of functioning     melanocytes from epidermal basal layer resulting in white patches on the skin and     occasionally mucosae. Worldwide prevalence of vitiligo is around 1% whereas in India it is     around 3-4% ranging from 0.46% to 8.8%.      Etiopathogenesis of vitiligo is multifactorial consisting of genetic, immunological and     environmental factors. Environmental and genetic factors act in concert to destroy     melanocytes. Reactive oxygen species (ROS) play important roles in vitiligo pathology,but the     autoimmune pathogenesis has been proposed as one of the main causes of vitiligo.      Surgical methods, mainly transplantation of non cultured epidermal cell suspension are     effective treatment for stable vitiligo. Transplantation of autologous noncultured epidermal     cell suspension and non-cultured dermal cell suspension in combination (a mode of cellular     grafting technique) is a novel surgical method for the treatment of vitiligo. Cytotoxic CD8+     ( cluster of differentiation 8+) cells in vitiligo perilesions may dictate the fate of     transplantation, and strategies against CD8+ T cell activation might be beneficial for     patients undergoing melanocyte transplantation. Mesenchymal cells could inhibit T cell     proliferation and induce T cell apoptosis. Bartsch first identified and characterized dermal     mesenchymal cells (DMCs). They have a multi-lineage differentiation potential into     adipocytes, osteocytes and chondrocytes.Vitiligo patients' autologous melanocytes     transplantation efficiency may be predicted by perilesional skin-homing CD8+ T cell     activities, and the immunoregulatory DMCs might be used as auxiliary agent to improve the     efficacy.      This pilot study is planned to compare transplantation of autologous noncultured epidermal     cell suspension v/s its combination with non-cultured dermal cell suspension as a novel     method in vitiligo surgery in stability of vitiligo with regards to extent of repigmentation,     color matching of repigmented area, patient satisfaction and adverse events if any. This is     the first study using transplantation of autologous noncultured epidermal cell suspension and     non-cultured dermal cell suspension in combination as a new modality in vitiligo surgery.   "
20821|NCT03013036|"     Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of     thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube     size by using USG in pediatric patients undergoing elective surgery.   "
20822|NCT03013023|"     This randomized controlled trial will use a longitudinal repeated-measures design to examine     the effects of two interventions, behavioral support interventions and a parent-infant     transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions,     and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional     regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.   "
20857|NCT03012568|"     This is a clinical investigational plan (CIP) for the Clinical Study to Confirm MRI Safety     and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI). This study     intends to enroll patients who meet standard bradycardia or tachycardia indications and have     already been implanted with one of the SJM device/lead combinations listed in this protocol.     The objective of this study is to confirm the safety and effectiveness of each of the four     SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored     by St. Jude Medical.   "
20823|NCT03013010|"     Although the incidence of gastric cancer has been substantially declining for several     decades, it is still the sixth most common cancer and the fourth most frequent cause of     cancer death worldwide. Surgery is still the only curative option for gastric cancer.     However, most patients are unable to undergo surgery because of late stage, unresectable     disease. The prognosis for these patients is very poor. Although the Magic trial showed that     perioperative chemotherapy can increase the rate of curative surgery and significantly     improve overall survival in patients with operable gastric or lower esophageal     adenocarcinomas, no pCR events were reported in this trial. The intervention arm in PREACT     consists of pre-operative chemotherapy, pre-operative radiochemotherapy, surgery and     post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery,     and post-operative chemotherapy. The primary purpose of PREACT is to investigate whether the     addition of radiochemotherapy to chemotherapy is superior to chemotherapy alone in the     pre-operative setting in improving disease free survival in patients with locally advanced     gastric or esophagogastric junction adenocarcinoma.   "
20824|NCT03012997|"     Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be     ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II     will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to     the arterial blood gas sample results) during surgery and in Postoperative care unit.      Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate     ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and     post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.   "
20825|NCT03012984|"     Delirium is a frequently occurred cerebral complication in elderly patients after surgery,     and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be     one of the most important risk factors of postoperative delirium. Previous studies showed     that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine     infusion improved the quality of sleep and decreased the incidence of delirium. The     investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine     supplemented analgesia can also decrease the incidence of delirium, possibly by improving     sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate     the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly     patients after cancer surgery.   "
20826|NCT03012971|"     A majority of the elderly patients undergo surgery for malignant tumors. For these patients,     postoperative tumor recurrence and metastasis are main factors that worsen long-term     outcomes. The investigators hypothesize that dexmedetomidine supplemented analgesia in     elderly patients after cancer surgery may help to maintain immune function and improve     long-term outcomes, possibly by relieving stress and inflammatory response, improving     analgesic efficacy and sleep quality, and reducing delirium incidence.   "
20827|NCT03012958|"     The purpose of this study is to learn more about new noninvasive ways of detecting lung     disease in US Military personnel and people who worked as contractors during military     operations in Iraq and Afghanistan. This study is looking at conducting a type of breathing     test called the lung clearance index (LCI) test which is being investigated as a potential     noninvasive way to detect the type of lung disease that may be seen in symptomatic deployers     retuning from Iraq and Afghanistan.   "
20828|NCT03012945|"     Surgical resection is one of the most important treatments for malignant tumor; on the other     hand, tumor recurrence and/or metastasis are the major reasons of treatment failure. The     outcome after surgery mostly depends on the balance between the immunity of human body and     the capability of implantation, proliferation and neovascularization of the tumor.     Preclinical and retrospective studies suggest that anaesthetic techniques and drugs may     affect the long-term prognosis in patients undergoing cancer surgery. The investigators     hypothesize that epidural anesthesia-analgesia may improve the long-term outcome of the     elderly patients who are scheduled to undergo major thoracic and abdominal surgery for the     treatment of malignant tumor.   "
20829|NCT03012932|"     The proposed study will examine the implementation of a Human Papilloma Virus (HPV)     self-sampling intervention for under screened LBQ women living in South Florida. The study     will enroll participants to receive the self-sampling intervention in community venues. The     purpose of this study is to pilot the self-sampler for feasibility and acceptability within     this underserved population.   "
20830|NCT03012919|"     Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing     goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and     vasoactive agents. There have been many subsequent protocols to improve outcome in the     operating room or in the ICU. These are mainly passive decision support systems. Active     clinical decision support systems using fluid and pharmacologic agents to improve     intraoperative hemodynamics are not really found.      The investigators developed an active clinical decision support system based on an     institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid     device.      The goal of the study was to check the feasibility of an active clinical decision support     system to optimize hemodynamics during high risk vascular surgery based on the principles of     GDT implementing fluid, vasopressors and inotropes.   "
20831|NCT03012906|"     Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and     requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are     required to receive triple antithrombotic therapy . This triple therapy includes dual     antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant     with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).      Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the     coagulation cascade have demonstrated non inferiority compared to VKA to prevent     thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 .     Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA.     Overall they seem to result in a lower bleeding rate compared to VKA in association with     antiplatelet agents.      Recently European guidelines regarding patients requiring chronic anticoagulant therapy and     undergoing coronary stent implantation have been updated. However they are based on an expert     consensus because of the scarce data available.      These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and     aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5     . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and     thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines     suggest that a sole antiplatelet agent could be used in addition to anticoagulation following     the WOEST study . In the recently published ESC guidelines on the management of atrial     fibrillation, despite the lack of new data, the expert advocate triple therapy followed by     dual antiplatelet therapy in most patients for 12 months.      The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in     these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban     15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically     relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar     efficacy .   "
20833|NCT03012880|"     This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and     daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block     cancer growth in different ways by targeting certain cells. Giving ixazomib citrate,     lenalidomide, dexamethasone, and daratumumab may work better in treating patients with newly     diagnosed multiple myeloma.   "
20834|NCT03012867|"     Different enteral nutrition formulas are tested on their effect on glucose homeostasis in     critically ill medical patients.   "
20835|NCT03012854|"     This study compares the clinical efficacy of safety of circular myotomy and full-thickness     myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in     achalasia patients.   "
20836|NCT03012841|"     To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac     CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent     atrial fibrillation.   "
20837|NCT03012828|"     This study will investigate the effect of a single oral dose of moxidectin on the QT interval     associated with moxidectin plasma concentrations.      The effect of moxidectin on other ECG intervals, and on safety, will also be assessed, as     will preliminary pharmacokinetics and metabolism   "
20838|NCT03012815|"     The current gold-standard for the management of alcohol withdrawal syndrome (AWS) is     symptom-triggered administration of benzodiazepines. This method of treatment has several     drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have     been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS     but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings     is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due     to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS,     a study to compare gabapentin to symptom-triggered lorazepam will be completed.   "
20839|NCT03012802|"     Short title POWER Audit      Methods 60 days national (Spain) audit of postoperative complications following elective     gastrointestinal surgery within an enhanced recovery after surgery (ERAS) protocol.      Research sites Hospitals undertaking elective lower gastrointestinal surgery. Objective To     provide detailed data describing post-operative complications and associated mortality; and     length of stay.      To provide detailed data describing adherence to ERAS protocol and its association to     morbidity.      Number of patients Not specified. All eligible patients undergoing surgery during the study     month. Inclusion Criteria All adult patients (aged ≥18 years) undergoing lower     gastrointestinal elective surgery within an ERAS protocol during the 60 day study period.      Statistical analysis Univariate analysis will be used to test factors (patient, surgical, and     ERAS related) associated with surgical complications, length of stay (LOS) and in-hospital     death. Single and multi-level logistic regression models will be constructed to identify     factors independently associated with these outcomes and to adjust for differences in     confounding factors. A stepwise approach will be used to enter new terms. A single final     analysis is planned at the end of the study.      Summary statistics with post hoc Bonferroni corrections will be used to assess possible     dose-response dependence in percentage of patients with postoperative complications and LOS.      Proposed Start Date A 60 day period between 2017      Proposed End Date      Data collection will end by September 2017      Study Duration Six months   "
20840|NCT03012789|"     The purpose of this study is to evaluate the effect of different surgical resections (R0, R1,     R2) on circulating NET transcripts (PCR score or NETest). A drop in circulating NET levels     will be correlated with surgical excision. Secondly, variation of circulating NET transcripts     will be correlated to NET recurrence to test whether this analysis may constitute an early     predictive marker of disease relapse.   "
20841|NCT03012776|"     The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System)     is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a     single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1)     at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or     retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint     capsule.      Success will be assessed by means of a composite endpoint that measures improvement in in     patient reported outcomes and the absence of any major device related complications.   "
20842|NCT03012763|"     The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine,     given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral     administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml     grapefruit juice prior to ingestion and to visualize the localization and to measure the     filling volume of stomach, small intestine as well as ascending, transverse and descending     colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water     (non-caloric water), after administration of 240 ml caloric drink and after administration of     240 ml grapefruit juice.   "
20843|NCT03012750|"     Microcirculation should be assessed before and after tibial bypass surgery by intraoperative     fluorescence angiography. According to this, the direct and the indirect angiosomes should be     compared according to the individual microcirculatory improvement.   "
20844|NCT03012737|"     An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea     in subjects with incurable advanced disease. Subjects are recruited from a local Hospice and     from oncology ward. The main outcomes are the compliance of the subjects with the treatment     and alleviation of dyspnea during the treatment period.   "
20845|NCT03012724|"     The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS,     (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the     FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously     unsuccessfully treated with antidepressant medications.   "
20846|NCT03012711|"     This study is an evaluation of the effects of a Neuromuscular training program on hip     strength and core stability. It is a randomized clinical trial evaluating pre and post     scores.   "
20848|NCT03012685|"     Most people will experience a psychologically traumatic event, such as a life-threatening     accident, at some point in their life. In the initial days after such an event, it is common     to be haunted by intrusive memories: image-based memories of the event that spring to mind     unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark     symptom of post-traumatic stress disorder (PTSD).      Sleep is important for many functions involved in how people perceive, respond to and     remember events, including stressful/traumatic events. Studies with patients who have     experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma     are associated with later PTSD symptoms. However, in a previous study with healthy volunteers     exposed to experimental trauma (film footage), those who were sleep-deprived in the first     night, compared to those who slept, had fewer intrusive memories in the following week. This     raises the question of how sleep in the first night, but also the first week, after real-life     trauma is related to subsequent intrusive memories and PTSD symptoms.      The current study is an observational study of patients recruited from a hospital emergency     department after a traumatic event. After completing brief baseline questionnaires in the     emergency department, participants will be asked to fill in a daily diary of their sleep and     intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and     depression will be assessed by post/online at one week and two months. Participants will be     telephoned after two months to complete an interview to assess PTSD symptoms and an optional     feedback interview.      This clinical study will be the first to assess the relationship between sleep in the first     night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings     may have implications for developing simple sleep-based preventive treatments after trauma in     the future.   "
20870|NCT03012399|"     The goal of this clinical research study is to learn if it is possible to perform a     relaxation method called hypnosedation before and during breast cancer surgery in order to     avoid the need for general anesthesia. The safety of this procedure will also be studied.   "
20849|NCT03012672|"     This randomized pilot trial studies how well higher or lower dose cladribine, cytarabine, and     mitoxantrone work in treating medically less fit patients with newly diagnosed acute myeloid     leukemia or myeloid neoplasm. Drugs used in chemotherapy, such as cladribine, cytarabine, and     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet     known whether giving cladribine, cytarabine, and mitoxantrone at higher or lower dose may     work better in treating patients with newly diagnosed acute myeloid leukemia.   "
20850|NCT03012659|"     The purpose of this study is to assess the impact of a provider counseling training on     patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10     Planned Parenthood health centers.   "
20851|NCT03012646|"     This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled     treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with     Chronic Obstructive Pulmonary Disease (COPD).   "
20852|NCT03012633|"     During liver transplantation (LT), hyperfibrinolysis is one of the most important     modification of haemostasis. It is associated with t-PA and protein C increased activity.     Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The     diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA,     PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the     clinical practice in the operating room.      The Lysis Timer is a device developed by Hyphen-Sysmex in collaboration with SD Innovation     and Charleroi University Hospital (Belgium). It allows the implementation of the Global     Fibrinolytic Capacity, or GFC test, in a complete system associating i) the reagents for in     vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and     calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal     of the absorbance modifications related to clot formation into a numeric signal) and iii) a     dedicated software treating the numeric signal to define clot lysis time.      The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the     diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.   "
20853|NCT03012620|"     This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy     and safety of pembrolizumab monotherapy in 6 cohorts of patients with specific rare cancers     who have unresectable locally advanced or metastatic disease, which is resistant or     refractory to standard therapy, or for which standard therapy does not exist, or is not     considered appropriate, and for which no other experimental treatment options are available,     in order to identify subsets of patients that may benefit from treatment   "
20854|NCT03012607|"     Adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are critical to     the success of HIV treatment and therapeutic prevention. No accurate, objective point-of-care     test is available to monitor adherence to either ART or PrEP. The inability to accurately     identify poorly adherent patients will lead to more HIV infections (from failed PrEP and     non-suppressive ART), more drug-resistant virus (selected by failing ART), and unnecessary     switching to costly second- or third-line ART (when first-line regimens with virologic     efficacy but non-adherence are stopped inappropriately). To address this critical knowledge     gap, the investigators have developed a novel point-of-care test to detect the presence of     tenofovir—the most common drug in both ART and PrEP treatments worldwide—in fingerprick blood     or urine as an objective measure of ART and PrEP adherence.      Our central hypothesis is that the pharmacokinetics of tenofovir in blood and urine will     support point-of-care tenofovir detection as an objective measure of adherence, and that our     point-of-care tenofovir assay will have the ability to discriminate different drug adherence     levels. The investigators will test our central hypotheses by pursuing the following two     specific aims: (1) To assess our novel point-of-care tenofovir (TFV) assay in whole blood and     urine specimens within a controlled pharmacokinetic study of HIV-negative adults receiving     tenofovir disoproxil fumarate (TDF) with low, moderate, and perfect adherence; and (2) To     validate our novel point-of-care tenofovir (TFV) assay on blood and urine specimens using an     existing biorepository from a real-world clinical HIV prevention study.      This work is innovative because it develops an entirely new category of rapid diagnostic     testing for monitoring ART and PrEP adherence at the clinical point of care. Our rapid assay     will help clinicians identify patients in need of more adherence counseling, which when     implemented will prevent HIV acquisition, emergence of drug resistant virus, and unnecessary     ART regimen switching—measures that will improve national HIV programs and help preserve the     global supply of an effective HIV medication.   "
20855|NCT03012594|"     This is a human research study looking at the effectiveness of Lanreotide (study medication)     in treating small bowel motility disorders. It is similar to a natural hormone somatostatin     that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a     growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting     medication that is given once a month. It is marketed with a trade name Somatuline Depot.     It is given deep subcutaneously (deep within the layers of the skin) in the superior external     quadrant of the buttock. Injection site will be alternated on subsequent injections.   "
20856|NCT03012581|"     This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy     and safety of nivolumab monotherapy in 5 cohorts of patients with specific rare cancers who     have unresectable locally advanced or metastatic disease, which is resistant or refractory to     standard therapy, or for which standard therapy does not exist, or is not considered     appropriate, and for which no other experimental treatment options are available.   "
24197|NCT02968940|"     The purpose of this study is to test how safe and effective treatment with the combination of     Avelumab and radiation is for IDH mutant gliomas that have transformed to glioblastoma after     chemotherapy.   "
20858|NCT03012555|"     There are approximately 90,000 individuals in the United States with sickle cell disease     (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a     vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to     20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic     inflammation and related pain. This study will be coordinated with patients' regularly     scheduled visits for medical care and will require patients to submit blood sample at the     start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for a     bone density measurement (DXA scan) at the start of the study and after 12 months of     supplementation to assess for any bone re-mineralization. Thus, the main purpose of this     study is to find the amount of nutritional vitamin D that needs to be taken by patients with     sickle cell disease in order to correct vitamin D deficiency. The study will also test     whether vitamin D supplements improve bone health and reduce inflammation.   "
20859|NCT03012542|"     Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom     control and disease remission. Historically certain diets have been recommended for patients     with Crohn's disease during exacerbations despite lack of data supporting efficacy. The     investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to     moderately active Crohn's disease to one of two diets that differ in the amount and type of     carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated     for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the     microbiome.   "
20860|NCT03012529|"     The purpose of this research study is to determine if rifampin, an antibiotic (a medicine     that treats infections), is effective in treating osteomyelitis (infection of the bone) of     the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long     period of time, many diabetic patients remain at a high risk for needing an amputation of     part of the foot or lower leg because the osteomyelitis is not cured. Some small research     studies have shown that addition of rifampin to other antibiotics is effective in treating     osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with     osteomyelitis have been studied, there is no definite proof that it is better than the usual     treatments for diabetic patients. If this study finds that adding rifampin to the usual     antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be     able to more effectively treat many Veteran patients with this serious infection. Improving     treatment outcomes is an important healthcare goal of the VA.   "
20861|NCT03012516|"     The aim of this study is to evaluate a one year intervention with physical activity on     prescription (PAP) treatment for patients in a primary health care center setting versus an     enhanced PAP-support with physiotherapist regarding physical activity (PA) level, metabolic     health effects and health-related quality of life.      One hundred ninety patients, 27-85 years, physically inactive, having at least one component     of the metabolic syndrome and not responding with increased PA level after a 6-months     PAP-treatment in primary health care centre are randomized to either enhanced support by     physiotherapist (Intervention group) or continued ordinary PAP-treatment at the health care     centre (Control group).   "
20862|NCT03012503|"     Background: Neck pain effects a significant number of individuals and is commonly treated     with chiropractic cervical manipulation. The temporary increases in neck pain following     cervical manipulation may contribute to a lack of compliance with prescribed therapy that     following this therapy which in turn commonly contributes to protracted symptoms. Topical     menthol has previously been shown to decrease pain shortly following application. The purpose     of this study was to determine if patients with mechanical neck pain who received topical     menthol gel applied to their neck prior to cervical manipulation would have less pain and     increased neck range of motion following cervical manipulation than patients who did not     receive menthol.      Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were     randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before     cervical manipulation, controls received a placebo gel applied to their neck while the     treatment group received a menthol containing gel (Biofreeze®) applied to their neck.     Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at     one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical     manipulation. Six measures of neck range of motion were assessed prior to topical     applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain     ratings and neck range of motion following manipulation while controlling for Pre measures.   "
20863|NCT03012490|"     The primary objective is to determine whether comprehensive remote follow-up in HF patients     with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure     hospitalizations, whichever comes first, when compared to basic remote monitoring, over a     27-month follow-up.   "
20864|NCT03012477|"     This research study is studying a combination of drugs as a possible treatment for     triple-negative breast cancer that has spread to other areas of the body. The names of the     study interventions involved in this study are:        -  Cisplatin        -  AZD1775   "
20865|NCT03012464|"     Patients aging less than 45 years with rectal prolapse will undergo full pathologic and     functional assessment to determine the underlying etiology.   "
20866|NCT03012451|"     The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an     innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living     in urban settlements in Jordan. The study was conducted using two waves of data collection:     the first featured an intervention and a matched control group, the second featured a full     randomized control trial.   "
20880|NCT03012269|"     This study aims to conduct a contrast study on the characteristics of functional and     structural connectivity of neural networks of working memory in patients with acquired brain     injury versus normal controls, using resting-state functional connectivity magnetic resonance     imaging, task-specific functional magnetic resonance imaging and diffusion tensor imaging,     combined with cognitive behavioral examinations. Another purpose is to reveal the     characteristics of dynamic change of neural networks of working memory pre- and     post-intervention in patients with working memory dysfunction.   "
20995|NCT03010774|"     Currently, all patients in the hospital are woken up throughout the night to check for vital     signs, no matter how sick they are. The investigators are doing this study to determine     whether skipping routine vital sign checks at night improves participant sleep quality and     satisfaction without increasing the risk of adverse events.   "
20867|NCT03012438|"     During surgery in which the thyroid is removed (thyroidectomy), the identification of     parathyroid glands, that should be saved, can be challenging. Therefore, there is need for     accurate intraoperative guidance. Earlier animal studies show that the parathyroid glands can     be identified by the use of the Near Infrared Fluorescent dye Indocyanine green (ICG).      Our hypothesis is therefore, that the use of ICG-based fluorescence imaging during thyroid     surgery will provide real-time intraoperative visualization of the parathyroid glands.      This prospective observational feasibility study aims to evaluate the feasibility of the use     of ICG in identifying the parathyroid glands during thyroid surgery. 30 patients (age >18     years) who are already regularly scheduled for thyroid surgery; i.e. patients undergoing     total thyroidectomy are suitable for inclusion. In all patients, undergoing total     thyroidectomy infrared fluorescence imaging, using a per-operative intravenous injection of     7.5 mg ICG, will be tested on feasibility and imaging characteristics.   "
20868|NCT03012425|"     The other aim of this study is to determine which of those two treatments (acupuncture or     cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of     cancer patients.   "
20869|NCT03012412|"     The current study aims to test the efficacy a mindfulness based intervention for women facing     fertility problems - the Mindfulness Based Program for Infertility (MBPI). MBPI comprises 10     weekly group sessions of approximately 2 hours each, run in small groups of 10-15 women. The     main goal of MBPI intervention is to reduce depressive and anxiety symptoms and promote     infertility self-efficacy and acceptance and mindfulness skills. The MBPI is intended to     develop willingness/acceptance through a process of contacting the present moment and be in     touch with the unfolding experience in an open and non-judgmental way, particularly     infertility-related experiences.   "
20871|NCT03012386|"     This proposal will test the hypothesis that chronic treatment with sildenafil with and     without the use of nitric oxide substrate, L-arginine, protects against fatty acid induced     impairment of endothelial function, improves insulin-stimulated microvascular recruitment,     insulin sensitivity and glucose uptake in CD36 rs3211938 G-allele carriers.   "
20872|NCT03012373|"     This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of     efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy     both combined with methadone treatment services for heroin addicts.   "
20873|NCT03012360|"     Antimicrobial treatment could be beneficial in patients with ventilator-associated     tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3     or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition     from VAT to ventilator-associated pneumonia (VAP).   "
20874|NCT03012347|"     To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use     testing, in a controlled indoor environment   "
20875|NCT03012334|"     This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square design     with 5-period (full) crossover study with subjects randomized to treatment sequences.     Subjects will complete all 5 Periods.      During each Period, subjects will come to the clinical research unit (CRU) and remain     overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo     in the morning. Cognitive testing and driving simulation will be conducted post dosing.     Subjects will have a washout of at least 5 days between each Period.      This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with     an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect     treatment effects.   "
20876|NCT03012321|"     This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men     with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have     ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a     1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including     FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2,     MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.   "
20877|NCT03012308|"     As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements     allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound     parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E     'ratio), are well validated in medical cardiology and in some resuscitation patients. The     measurement of filling pressures is an important daily element in the medical management of     patients in intensive care, in particular on the hemodynamic and respiratory levels. No     studies have evaluated the relevance of these markers in a postoperative context of cardiac     surgery. Indeed, the surgery alters the cardiac function, which could modify the values of     the echocardiographic parameters and their predictability. Left atrium pressure (LAP)     directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically     placed catheter as part of routine institutional care and will serve as gold-standard. To     study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound,     we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).   "
20878|NCT03012295|"     Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most     important causes of hypertension. Generally, patients occur hypertension in early age, have     family history, and often manifest severe hypertension or refractory hypertension. At     present, only a few hypertension centers of hospitals in China will help clinically difficult     diagnosis hypertensive patients to test some selective genes, while most of other hospitals     still perform diagnosis based on biochemical examination and clinical symptoms. Therefore, in     order to provide better guidance for the diagnosis and treatment for hypertensive patients,     this project aims to develop a single gene detection panel for genetic hypertension, so as to     provide new diagnostic technology for early intervention, prevention and treatment of     hypertension in clinics.   "
20879|NCT03012282|"     This pilot clinical trial studies how well computed tomography (CT) perfusion images work in     assessing treatment response in patients with pancreatic cancer. Analyzing specific     measurements on the CT perfusion images may help doctors better determine how a tumor     responds to chemotherapy and/or radiation therapy and may help guide treatment for patients     with pancreatic cancer.   "
23649|NCT02976103|"     This research study is studying a garment called the Jacki® recovery jacket that can be worn     after surgery as a possible way to manage pain from surgical drains.      The study intervention involved in this study is:      -Jacki recovery jacket   "
20891|NCT03012126|"     This project seeks to build on innovative strategies to optimize the care of low-income     children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement     a new clinical-community intervention, theoretically grounded in the Integrated Clinical and     Community Systems of Care Model, to address obesity through optimized screening and     management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy     Weight and Your Child weight management program (originally known as MEND). The study will     examine outcomes for children that matter most to a broad group of stakeholders including     parents, clinicians, and public health practitioners as well as inform the care of >7 million     children with obesity covered by the Children's Health Insurance Program or Medicaid.   "
20892|NCT03012113|"     Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian     individuals (representing 20% of the world population) have an increased risk of obesity and     related disorders. They are at higher risk for the development of T2D as compared to white     Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms     that might explain these ethnical differences have not been clarified or understood yet. As a     consequence, treatment options are limited and unfocussed, and novel specific strategies are     needed.      Brown adipose tissue (BAT) has recently been discovered as a major player in energy     metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and     glucose from the circulation and subsequently combusts FA and glucose into heat, thereby     increasing energy expenditure and improving glucose and FA metabolism. Using     18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT     scan analysis investigators have recently shown that South Asian individuals have less brown     adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy     metabolism, which could underlie their increased predisposition for obesity and the     development of T2D.      Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic     effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis,     glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore     activation of BAT is considered as a novel therapeutic target in the treatment of obesity and     T2D. As cold exposure is not the most desired therapeutic strategy for humans, current     pre-clinical research focuses on pharmacological activation of BAT.      β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies     using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor     agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even     attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist     (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as     cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to     activate BAT and enhance energy expenditure, especially for South Asians.      Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However     this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI,     which has no radiation burden, has emerged as a novel method to visualize BAT in humans.     Activation of BAT results in combustion of intracellular lipid stores, which eventually leads     to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using MRI     technology the activation of BAT can be quantified by the relative reduction in the TG     content of BAT. The use of MRI to visualize and quantify BAT activity is a safe,     cost-effective and innovative alternative to PET-CT, which has a potential to become a new     gold standard in the nearby future.      To investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic     phenotype of South Asians, investigators will perform a randomized cross-over study in which     20 healthy young men aged 18-30 years with a lean body type (BMI <25 kg/m2) are included.     Dutch South Asian individuals (n=10) and matched Dutch white Caucasian individuals (n=10)     will participate in a cross-over study consisting of three different regimes.      This study will investigate whether β3-receptor agonism has therapeutic potential to improve     the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT activity     in South Asians have never been studied before. Elucidating the effects of this β3-receptor     agonist on BAT activity in South Asians might have major clinical implications, as it might     result in the discovery of a potential novel treatment strategy to combat obesity and T2D in     this especially vulnerable population.   "
20893|NCT03012100|"     This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide     vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative     breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may     help the body build an effective immune response to kill tumor cells. Drugs used in     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and     cyclophosphamide may work better in treating patients with triple negative breast cancer.   "
20881|NCT03012256|"     Rationale:      In Canada, home care clients are a large and expanding subgroup of medically complex older     adults with relatively poor access to effective chronic disease management. They have double     the emergency department utilization rate compared to nursing home residents or other older     populations. The investigators previously published a case-finding tool (the Detection of     Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been     recommended for chronic disease management case-finding in home care. The investigators     recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of     supportive cardio-respiratory disease management.      Objectives:      The investigators will evaluate a cardio-respiratory disease management model in home care to     manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic     cluster-randomized trial will be conducted by a collaboration of trial investigators and     public home care providers (i.e., health regions).      The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a     targeted, person-centered cardio-respiratory management model.      The main question is:      P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted     using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex,     cardio-respiratory management model, C: compared to regular care, O: reduce     cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits,     reduce unplanned hospital use, improve patient activation, or improve health-related quality     of life for clients, T: over a 6-month follow-up period from baseline?   "
20882|NCT03012243|"     In order to compare percutaneous cholecystostomy and leaving a drain in situ with     percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled     trial.   "
20883|NCT03012230|"     This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given     together with pembrolizumab in treating patients with stage IV triple negative breast cancer     that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab,     may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     pembrolizumab and ruxolitinib phosphate together may work better in treating patients with     stage IV triple negative breast cancer.   "
20884|NCT03012217|"     This is a performance study to test the sensitivity and specificity of the BioFire FilmArray     Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test     residual NPS specimens and generate performance data to support regulatory classification of     the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and     other regions.   "
20885|NCT03012204|"     To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb     motor dysfunction due to cerebral vascular disease.   "
20886|NCT03012191|"     Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited     skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7),     the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal     adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators     recently demonstrated in 5 such patients that intradermal and topical gentamicin induced     read-through of their nonsense mutations and created robust and sustained new C7 and AFs at     the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and     reduced new blister formation. No untoward side effects occurred. Herein, the investigators     propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In     theory, this intravenous administration has the possibility of treating simultaneously all of     the patients' skin wounds. The investigators also propose optimizing the concentration and     manner of delivery of topical gentamicin. The unambiguous milestones will be increased C7 and     AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of significant     gentamicin side effects.   "
20905|NCT03011944|"     A nutrition-focused QIP will be implemented as standard of care at select branches of the     home health division of the health care system. The QIP will be comprised of two groups of     patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being     discharged to home health, and Group 2 will consist of outpatients at-risk/malnourished     patients enrolled in home health. Both groups will be followed for 90 days post enrollment.     The QIP groups will be compared to historical controls, concurrent controls, and matched     concurrent controls across other sites within the health system.   "
20906|NCT03011931|"     To study the correlation between simvastatin metabolism by the enterocyte and the histologic     state of the intestine in treated celiac disease.   "
20944|NCT03011437|"     There are lack of endoscopic criteria for diagnosing Helicobacter pylori (H. pylori)     infection by conventional white light imaging (WLI). Linked color imaging (LCI) is a newly     developed endoscopy technique, which can diagnose mucosal lesions and H. pylori infection by     enhancing color contrast of the mucosa. The aim of the study is to investigate the ability of     LCI for diagnosing H. pylori infection compared with WLI.   "
20887|NCT03012178|"     Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the     severity of mitral regurgitation is central to determining which patients are appropriate for     correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is     made, patients are considered appropriate for mitral valve surgery in almost all clinical     circumstances. However, there is a significant mortality and morbidity associated with mitral     valve surgery The most common diagnostic tool to assess the severity of MR is     echocardiography. Several studies have shown that echocardiography parameters used to     quantify and qualify MR have high inter-observer and intra-observer variability, calling the     accuracy of these parameters into question. Furthermore, studies have shown that there is a     significant degree of discordance between echocardiography and MRI when assessing MR,     particularly among patients referred for mitral valve surgery. In a recent study,     quantification of mitral regurgitant volume MRI was found to be more accurate than     echocardiography in patients who underwent mitral valve surgery. All 38 patients who     underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA     guidelines based on echocardiographic findings. However, more than 2/3rds of patients who     underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose     this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients     undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and     healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post     surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs.     repair according to MR severity by MRI.   "
20888|NCT03012165|"     A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the     Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102     Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic     Conjunctivitis.   "
20889|NCT03012152|"     This non randomized study is a comparative study between standard conservative breast surgery     and oncoplastic surgery as regard margin status and patient satisfaction.   "
20890|NCT03012139|"     This study is designed to gain a better understanding of the mechanisms leading to muscle     wasting and metabolic abnormalities in skeletal muscle of cancer patients.   "
20894|NCT03012087|"     The aim of this study is to pilot test a web-based, patient-centered educational program that     encourages the patient to have an informed discussion about pain medication options with     their emergency department (ED) provider.   "
20895|NCT03012074|"     This study will use mobile health technologies to provide everyday data to help patients and     their care providers better understand illness dynamics and develop adaptive approaches to     improve health outcomes in diabetes. Specifically, the study will identify strategies to help     patients adapt using multiple types of self-generated diabetes-related data and help     providers guide patients to better self-manage in real-time, when guidance is needed most.   "
20897|NCT03012048|"     This project is a community-based randomized controlled trial designed to test the     effectiveness of two point-of-use water treatment technologies to improve clean drinking     water access, reduce enteropathogen burden, and improve child growth among children in     Limpopo, South Africa.   "
20898|NCT03012035|"     This study evaluates the role of treatment success expectation in spider fearful individuals     on the actual treatment success. Half of participants will have positive treatment success     expectations, while the other half will have neutral treatment outcome expectations.   "
20899|NCT03012022|"     The purpose of this research study is to investigate the role of chemical reactions, such as     inflammation and oxidation, in the cause of cardiac dysfunction (the heart does not function     properly). The investigators are interested in studying the various chemical pathways for     cell damage to determine which are the most prevalent and/or most important. The     investigators also want to determine whether waste products of oxidative damage or other     chemicals can be monitored in the blood or urine and serve as an indication of the existence     and severity of overall heart disease activity. The investigators further want to determine     whether certain proteins, called enzymes, affect this cell damage, or whether the presence or     absence of certain genes which create different forms of these enzymes correlate with the     development of heart failure or cardiomyopathy (weakening of the heart muscle or a change in     heart muscle structure) or other cardiovascular diseases.   "
20900|NCT03012009|"     Photodynamic therapy (PDT) is a well established treatment option for superficial non     melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD).     However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate     (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has     recently been studied in order to enhance the skin penetration of this photosensitizer. This     study compares the results of a full ablative and a fractional ablative CO2 laser mode as     pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain,     aesthetics and patient preference are investigated during twelve months of follow up.   "
20901|NCT03011996|"     Cohort 1      To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of     CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects.      Cohort 2      To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in     combination with amoxicillin/clarithromycin in healthy subjects as compared to an active     control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.   "
20902|NCT03011983|"     This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain     injury and to improve understanding of the biological basis of brain pathology in adolescents     with concussion. Adolescents with a concussion will undergo neuroimaging and neuropsychology     assessments acutely and four months after injury.   "
20903|NCT03011970|"     The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala     response vary as a function of treatment dose and dose-test latency.   "
20904|NCT03011957|"     MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy     (ART) and demographically matched uninfected adults to evaluate muscle and aging.   "
20940|NCT03011489|"     Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed     aligners in order to evaluate its effect on Nasoalveolar complex.   "
20907|NCT03011918|"     Falls and falls related injuries are considered one of the most adverse events that a patient     can experience. Several assessment instruments to assess and mitigate risks for falls have     been developed. However, these instruments have not addressed nutritional risk factors.      Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the     hospital setting is a significant concern and may play a role as a fall risk factor.      The World Health Organization (WHO) maintains a global anemia database. WHO has identified     iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread     nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including     industrialized nations.      The consensus statement of the Academy of Nutrition and Dietetics / American Society of     Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of     inadequate intake along with a multitude of other factors. Weight loss occurs at multiple     points along this continuum.      this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss     and degree of Hgb decline may be fall risk factors.   "
20928|NCT03011645|"     The purpose of this study is to identify gene variants that increase risk of cardiovascular     disease (CVD) and type 2 diabetes, particularly genes related to stress factors.   "
20908|NCT03011905|"     Many patients have strong pain at brachial plexus block resolution after operations for     distal radius fractures with a volar plate. This study investigates if a single dose of     dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The     primary endpoint is difference in the highest pain score first 24 hours after surgery. The     investigators will also look at pain scores and analgesics consumption first few hours after     surgery and at different times up to 2 years after surgery.   "
20909|NCT03011892|"     The purpose of this study is to establish the efficacy of each strength of INCB018424 cream     once daily (QD) or twice daily (BID) in subjects with atopic dermatitis as compared with     vehicle cream BID.   "
20910|NCT03011879|"     The program is to improve STEMI medical care quality in China. With the documents issued by     National Health and Family Planning Commission of the People's Republic of China, the program     was initialed in at least 200 primary PCI capable hospitals together with hundreds of     adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset     within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30     patients will be enrolled consecutively from each PCI-capable center initially and from     non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI     capable hospitals will be enrolled and all of them will be followed up for 1 year. Key     performance indicators (KPIs) in STEMI care will be collected using both national PCI online     registry and a program STEMI online registry database for the purpose of improvement of     medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each     hospital after data analysis in each period. Comparison of every two cross-sectional data     (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the     improvement of medical quality.   "
20911|NCT03011866|"     Multilevel decompression and bone graft fusion is a most effective measure for treating     degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large     amount of perioperative blood loss and high demand for homologous blood transfusion.     Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in     various kinds of surgeries. However, high quality evidence of its efficacy and safety is     still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of     thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the     optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the     non-inferiority of topical TXA application to its intravenous use in multilevel decompression     and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head     comparison study design will be adopted.   "
20912|NCT03011853|"     Observational cohort study of mid-to-long term survival of patients with acute on chronic     obstructive pulmonary disease, analyzed per type of ventilation support provided during first     24 hours in intensive care.   "
20913|NCT03011840|"     This study aims to understand the benefits of imparting pre operative instructions through     written leaflets. The influence on the number of avoidable postponements and delay is also     studied.The study is restricted to patients undergoing Head & Neck procedures under General     Anaesthesia, at the minor OT complex at Tata Memorial Hospital   "
20914|NCT03011827|"     Thromboelastometry better assess coagulation than standard coagulation test in patients     undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study     recently conducted by our group, presurgical values of MA10 Extem < 35 mm are highly     predictive of RBC administration , with no further improvement over MA10 Extem >40 mm ;     suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product     administration. The aim of the study is to validate this result in a prospective cohort of     patients submitted to ortothopic liver transplantation.   "
20915|NCT03011814|"     This randomized phase I/II trial studies the best dose and side effects of durvalumab and to     see how well it works with or without lenalidomide in treating patients with cutaneous or     peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal     antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and     spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating     patients with cutaneous or peripheral T cell lymphoma.   "
20916|NCT03011801|"     This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among     pregnant women with elevated depressive symptoms. Half of the women will be randomized to     receive IPT, and the other half will get Treat As Usual, provided via behavioral health in     the hospital.   "
20941|NCT03011476|"     Cholinergic deficiency in the brain can be related to gait and balance problems in Parkinson     disease (PD). Recent clinical trials suggested a beneficial role of acetylcholinesterase     inhibitors (AchEI) on gait in PD. In this study, the investigators are planning to study the     influence of AchEI on a brain network for gait and balance in PD. As gait problem is     prominent in postural instability and gait disturbance (PIGD) subtype, this study will focus     on the patients with PIGD phenotype.   "
20917|NCT03011788|"     The aim of this randomized trial is to compare the proportion of patients achieving an     adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation     regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2     consecutive days in a population identified as high risk for an inadequate bowel preparation.      2. Research Design: This study is a single-center prospective randomized study at the West     Haven VAMC.      3. Methodology:        1. Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation          Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left,          transverse, and right).        2. Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated          polyp/adenoma detection rate, patient tolerability of preparation using the validated          Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to          bowel preparation      Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high     risk for poor bowel preparation,   "
20965|NCT03011164|"     Some researches have found that gait posture velocity have influence on kinematic parameters.     However, how the gait velocity and posture will influence kinematic parameters remain     unclear. In addition to walking, running is one of the most daily activities of people. The     purpose of this research is to find out the influence of gait velocity and running to     kinematic parameters . To do this, it will provide a reference for future prospective studies     or investigations and make us fully understand the impact of gait velocity and running to     kinematic parameters of gait.   "
21110|NCT03009266|"     The overall aim of this study is to determine whether non-invasive imaging with myocardial     contrast echocardiography using can provide information on the presence and spatial extent of     recent myocardial ischemia by non-invasive echocardiographic imaging.   "
20918|NCT03011775|"     Pioglitazone, a medication of thiazolidinedione group, is capable of triggering the     peroxisome proliferator-activated receptors (PPAR-γ). Activation of receptor PPAR-γ regulates     carbohydrate and lipid metabolism, immune and inflammatory responses in heart tissues.      Our aim will to study the effect of pioglitazone on insulin resistance, the clinical course     of atherosclerosis and coronary heart disease (CHD).      The study will include 43 patients with coronary artery disease. Patients will be divided     into the study group - 20 patients, in whom pioglitazone will be included in the combined     therapy at a dose of 15 mg 1 time per day in the morning, and the control group - 23 patients     receiving standard complex drug therapy over 6 months. Patients will be underwent clinical     examination, ultrasound of neck vessels, study of carbohydrate and lipid metabolism.      The end primary points of the study will be the onset of death due to myocardial infarction,     coronary revascularization procedures (coronary artery bypass grafting (CABG) or percutaneous     coronary intervention (PCI)), or hospitalization for acute coronary syndrome (ACS) or     unstable angina (UA).      Predefined secondary end points included carotic atherosclerotic leisure (carotic     intima-media thickness, diameter of stenosis, presents of atherosclerotic plaque), systemic     inflammation level (the level of C reactive protein), lipid metabolism (levels of serum total     cholesterol, triglycerides, high and low density lipoproteins), level of insulin resistance (     oral glucose tolerance test, blood glucose).   "
20919|NCT03011762|"     Sleep apnea is a condition in which the throat air passage closes during sleep and repeatedly     interrupts breathing. The standard treatment of sleep apnea is air pressure applied to the     nose, so-called nasal CPAP, but it is not suitable for all patients. Another treatment is to     use a dental appliance while asleep. In this treatment, an appliance covers the upper and     lower teeth and acts to pull the jaw forward, which opens the throat passage. This allows the     patient to breathe normally.      Dental appliance treatment does not work effectively in all patients. In order to identify     those in whom dental appliance therapy will be effective, the study sponsor has invented the     remotely controlled mandibular positioner, MATRx. The MATRx is an FDA cleared motorized     dental appliance which is used overnight in hospital sleep studies and works by pulling the     jaw outward under the control of a technician.      In order to eliminate the need for an overnight in hospital sleep study, the sponsor has     invented a new device that allows for the identification of individuals who are suitable     candidates for dental appliance therapy from the comfort of the home. Like with MATRx,     participants will sleep with a motorized mandibular positioner in place. But, it is     controlled by a computer, rather than a sleep technician, making it a computer controlled     mandibular positioner (CCMP). The feasibility and predictive accuracy of multi night testing     using the CCMP will be evaluated through participation in this study.      The sponsor has carried out two previous research trials leading to the development of the     CCMP. The first established the predictive accuracy of the remotely controlled mandibular     positioner at identifying candidates suitable for oral appliance therapy and their effective     therapeutic setting. The second established the accuracy of the algorithms used by the CCMP     to similarly identify successful candidates in a clinical setting. No significant problems     were identified in conjunction with our previous research protocol, and no significant risks     were identified. This third protocol is to establish the feasibility and accuracy of the CCMP     when used in the home setting.      The trial will utilize data collected over a series of nights to formulate a prediction of     therapeutic outcome with an oral appliance. The prediction will be tested by comparing the     degree of airway obstruction without treatment (from data collected prior to the study) to     the degree of airway obstruction with oral appliance therapy. A custom fit oral appliance     will be provided to participants as part of the trial.      The purpose of the study is to test the predictive accuracy of the CCMP in identifying     favorable candidates for oral appliance therapy and in determining an efficacious protrusive     position. Another purpose is to evaluate the convenience and possibility of carrying out a     multi-night CCMP study in the home.      There are no known risks or side effects to the CCMP studies, to the home studies, or to the     oral appliance therapy. It is possible that participants will have some discomfort during the     nights of the CCMP studies but this will be transient and not cause any long term damage.     Participants may experience soreness of the teeth or jaw joint during adjustment of the oral     appliance by the dentist. There is no risk of jaw dislocation or problems with the     temporomandibular joint (TMJ).      Participants will have the benefit of receiving a dental appliance for treating their sleep     apnea at no charge. This will be supplied to participants by a dentist who is an expert in     this field. Participation in the study will also allow the further development and ultimately     commercialization of the CCMP device which may help individuals who have sleep apnea.      Dental appliance therapy is just one of two therapies for sleep apnea. If participants choose     not to have the dental appliance therapy, they may wish to try nasal continuous positive     airway pressure. Participants may withdraw at any time during the study without compromising     their health care in any way. To withdraw, participants should simply notify one of the     physicians or the research assistant. If the sponsor obtains new information that might     affect an individual's willingness to participate in the study, they will be informed     immediately.   "
20920|NCT03011749|"     The aim of the study is to investigate whether positron emission tomography (PET) using the     tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone     marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of     hematological toxicity   "
20921|NCT03011736|"     This clinical trial studies the omission of intact parathyroid hormone testing during surgery     in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone     testing during parathyroid gland removal may help patients with primary hyperparathyroidism     to decrease their time under anesthesia, and decrease the overall time and cost of surgery.   "
20922|NCT03011723|"     This study evaluates the effect and process of individualized music therapy for home-dwelling     persons with mild to moderate dementia. The music therapy is administered individually and     includes a close caregiver. Memory of familiar music is found to be retained in persons with     dementia. It is assumed to facilitate autobiographical memories and stimulate interaction     with significant others. Based on time series analyses we will use statistical process     control to evaluate when and how change occur.   "
20923|NCT03011710|"     Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco     smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently     referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use     and awareness of these devices has grown exponentially in recent years, with millions of     people currently using them.      The benefits and risks of electronic cigarette use are uncertain. There is no research on the     acute oral effects of electronic cigarette in the scientific literature and no hungarian     epidemiological survey has been performed in this topic.      Regulation of electronic cigarettes varies across countries in the European Union, ranging     from no regulation to banning them entirely.      The investigators research could help to integrate the regulation of this device in Hungary     and in the EU as well.      The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey     would be novel in this topic.   "
20924|NCT03011697|"     Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has     brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart     disease are not so clear, especially in the developing countries such as China etc. Because     of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed     on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular     diseases are very common in China. Hence, we design a prospective, observational cohort study     to provide contemporary information on the prevalence, characteristics, risk     stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult     patients with valvular heart disease.   "
20952|NCT03011333|"     This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled,     multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic     efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via     ultrasound-guided lateral and medial pectoral nerve block before surgery.   "
20925|NCT03011684|"     Iatrogenic infertility as a result of cancer treatment has a profound effect on long-term     quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to     cancer treatment has been associated with improved quality of life, with a potential ability     to reduce long-term decision-related regret in cancer survivors. Though letrozole plus     gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in     ovarian stimulation cycles for fertility preservation in patients with     estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to     improved oocyte yield. Improved knowledge about the efficacy of these medications, with     regard to oocyte yield, has the potential to significantly improve quality of life in     reproductive-age breast cancer survivors.   "
20926|NCT03011671|"     We hypothesize that ACZ can be safely administered concomitantly with TMZ in patients with     malignant glioma and that this regimen improves patient survival without increasing toxicity     to an unacceptable level. Information gathered from this study will contribute towards the     development of a future larger phase II study in these tumors.   "
20927|NCT03011658|"     Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a     still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown     prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian     population. 75% of patients with cutaneous lichen planus also experience oral lesions and may     be precipitated or exacerbated by psychosocial stressors.      In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in     the body, the most common effect of which is increased cortisol level in blood. This hormone     is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of     carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive     index in stressful situations.      This study is intended to correlate the serum cortisol levels with anxiety and depression in     patients with symptomatic oral lichen planus. This study attempts to evaluate psychological     anxiety and depression in oral lichen planus subjects using Hospital Anxiety and Depression     Scale ( HADS) and correlating with their serum cortisol levels.      To understand and explore the etiopathogenesis for better management of oral lichen planus.   "
20929|NCT03011632|"     The project is intended to be realised in two phases. In the first stage, a case control     study will be performed. In the second phase, double-blind, placebo controlled study will be     conducted. In the first phase 3 groups of children will be compare: i) a group of children     suffering from chronic rhinosinusitis (CRS) (fulfilling the European Position Paper on     Rhinosinusitis and Nasal Polyps (EPOS) criteria) and asthma (fulfilling the Asthma Predictive     Index (API) criteria) (CRS+/asthma+, n=90), ii) a group of children suffering from CRS     (fulfilling the EPOS criteria) but without asthma symptoms (negative API criteria)     (CRS+/asthma-, n=30) and iii) a group of children without symptoms of CRS (negative EPOS     criteria) and without asthma symptoms (negative API criteria) (CRS-/asthma-, n=30). In the     second phase the effect of intranasal glucocorticosteroids will be assessed. The following     research methods will be used: CRS-symptom score questionnaire (SN-5) and Childhood Asthma     Control Test (cACT) questionnaires, skin prick test, spirometry, measurement of nitric oxide     NO in exhaled breath (FeNO), taste perception test, eosinophil morphology assessment, ratio:     glucose concentration in nasal secretion/serum glucose level, concentration of specific     immunoglobulin (Ig) E, total immunoglobulin G (IgG) and immunoglobulin A (IgA), the     proportion of innate lymphoid cells (ILC) and regulatory lymphocytes cells in the peripheral     blood. Endoscopic examination of the upper airways will be performed and samples of the     mucosa will be taken. The mucosal examination will be as follows: i) polymerase chain     reaction (PCR) examination for the detection of the presence of viral and bacterial genetic     material, ii) measurement of the expression of the various messenger ribonucleic acid (mRNA),     iii) measurement of the expression of mRNA for the Epithelial-Mesenchymal Transition (EMT)     genes and iv) percentage of ILCs.   "
20930|NCT03011619|"     Moderately to severely depressed subjects will be randomized to the Control Group, who will     receive care as usual, or the CBT Group, who will receive care as usual in addition to the     manualized course of Cognitive Behavioral Therapy (CBT).   "
20931|NCT03011606|"     The toxicity of traditional prostate cancer therapies including radical surgery and external     beam radiation is well known. This has prompted a move towards focal therapy where only the     cancerous part of the prostate is treated.      To date, studies have demonstrated very promising outcomes following focal therapy with the     majority of men maintaining their urinary and sexual function after therapy.      In a small proportion of men, disease recurs after focal therapy. The optimal treatment for     men with recurrent disease after focal therapy is yet to be defined. Patients may undergo     further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland     therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU)     or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate     is removed.      To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after     focal therapy has not been formally studied.      Traditionally, the side effects of surgery and radiation therapy performed in patients that     have already undergone previous prostate cancer treatment have been considerable with high     rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a     significant area of the prostate untreated, the investigators believe surgery after focal     prostate therapy will be associated with a much lower incidence of urinary and sexual     dysfunction.      The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in     men that have undergone prior focal ablation therapy. In addition, the investigators wish to     perform a number of basic science studies to attempt to better understand why the patient has     experienced recurrent prostate cancer after focal therapy.   "
20932|NCT03011593|"     This study assessed the effect of a nutrition support product on quality of life in adults     with compromised gut function and malabsorption.   "
20942|NCT03011463|"     The purpose of the study is:        -  to determine absolute bioavailability, input rates, distribution volume, renal and          intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and          rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or          rs12208357        -  to determine absolute bioavailability, input rates, distribution volume and renal and          intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1          rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor          ranitidine        -  to determine absolute bioavailability, input rates, distribution volume and renal and          intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1          rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor          clarithromycin        -  to determine absolute bioavailability, input rates, distribution volume and renal and          intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1          rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor          clarithromycin.   "
20933|NCT03011580|"     This Strategic Research Project is a translational proof-of-concept study that will determine     whether vitamin D3 has potential to prevent recurrent tuberculosis (TB), as indicated by     enhanced resolution of pulmonary inflammation detected using 18F-FDG PET-CT scanning. The     extent of pulmonary inflammation detectable on PET-CT scanning is a validated biomarker that     has previously been shown to predict risk of TB recurrence in patients taking anti-TB     treatment. The investigators propose to explore whether vitamin D3 can enhance resolution of     PET-CT-detectable pulmonary inflammation, on the basis of extensive preliminary data from in     vitro studies and a Phase 2b clinical trial that the investigators have conducted, showing     that high-dose vitamin D3 accelerates resolution of peripheral blood inflammatory responses     in patients with pulmonary TB.      Forty vitamin D-deficient patients who have completed 6 months' TB treatment, but who still     have residual pulmonary inflammation detectable on PET-CT scanning, will be allocated to     receive either an 8-week course of high-dose oral vitamin D3 supplementation or placebo     during the study period. The extent of pulmonary inflammation on PET-CT scanning will be     compared between intervention vs. control groups at 8-week follow-up.      If the study shows a positive result, it will generate valuable proof-of-concept data that     could be used to support an application to conduct a large phase 3 trial of vitamin D     supplementation to prevent TB recurrence.   "
20934|NCT03011567|"     This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs)     administered during the postpartum period influence blood pressure in women with hypertensive     disorders of pregnancy. The study design is a prospective double blinded randomized control     trial with participants randomized to receive postpartum analgesic regimens with and without     NSAIDs.   "
20935|NCT03011554|"     VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is     indicated for monocular implantation to improve vision in eyes of patients at least 65 years     of age with severe to profound vision impairment caused by bilateral central scotomas     associated with end-stage age-related macular degeneration (AMD).      Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular     lens placement are currently contraindicated for telescope surgery.      These patients have no viable therapy available to improve their vision.      The objective of the TES pilot study is to evaluate the safety and effectiveness of     implanting the intraocular telescope for improving vision in patients with bilateral     end-stage age- related macular degeneration who are pseudophakic.   "
20936|NCT03011541|"     This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the     treatment of retinal and optic nerve damage or disease.   "
20990|NCT03010839|"     During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle.The     myocardial injury is a serious complication ,which increases both mortality and morbidity of     cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb     ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive     strategy.Recent some trials suggested that RIPC could provide myocardial protection by     reducing serum cardiac biomarkers,however,whether the RIPC can improve the clinical outcomes     in patients undergoing on-pump cardiac surgery,is still uncertain.      The study hypothesis is: remote ischemic preconditioning will provide myocardial protection     and improve clinical outcomes in patients undergoing cardic surgery.   "
20937|NCT03011528|"     Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the     second decade of life. They start most often from bone, and are characterized by a specific     translocation involving the so-called EWS gene. In one patient out of three, the staging     procedures detect metastatic tumours at the diagnosis, most commonly in lungs, bones, and     bone marrow.      ESFT treatment strategy is multidisciplinary, combining primary chemotherapy, a local     treatment, and consolidation chemotherapy.      The primary metastatic dissemination is the most important prognostic factor, as the survival     rate is around 70-75% for localized tumours, in contrast with less than 50% for patients with     primary metastatic disease.      Among primary metastatic patients, bone involvement and / or bone marrow strike markedly the     prognosis of these patients. While the long-term survival of patients with isolated pleural     pulmonary metastases is approximately 50%, whereas it is only from 0 to 25% in patients with     bone marrow involvement.      In 1999, the Intergroup EURO EWING built a new study protocol for patients with Ewing     tumours. For the patients with primary extrapulmonary metastatic Ewing tumours (R3 patients),     the protocol proposed a heavy induction chemotherapy, in order to propose a consolidation     with high dose chemotherapy to a higher rate of patients. The high-dose Busulfan Melphalan     chemotherapy (BuMel) was based on Busulfan (600 mg/m²) and Melphalan (140 mg/m²), with     autologous peripheral blood stem cell (PBSC) support.      Of note, for the full population of patients with metastatic disease, the 3-year EFS rate was     27% (SD 3%), and the OS rate was 34% (SD 4%), with a median follow-up of 3.9 years after     diagnosis, and a median survival time of 1.6 years.   "
20938|NCT03011515|"     The purpose of this study is to validate the diagnostic accuracy of a novel host-response     based diagnostic tool for differentiating between bacterial and viral etiologies in adult     patients aged 18 years and older with clinical suspicion of lower respiratory tract     infections (LRTI)   "
20939|NCT03011502|"     Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota     imbalance, host-microbiota crosstalk dysfunction and inflammation.      As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly     interested in patients with Bone and Joint Infections (BJI). These patients are treated with     antibiotics having significant consequences on their intestinal flora, causing intestinal     discomfort, which can be manifested by diarrhea.      MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan     Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections     Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI).     The objective of this study is to follow patients with treated BJI in order to characterize     intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota     Transplantation (aFMT) intervention.      To do this, patients will be monitored according to the current CRIOAc recommendations, with     the aim of taking biological samples from patients at the same time as scheduled visits,     routine monitoring patients. Only one additional consultation will be carried out 15 days     after stopping the antibiotics in order to better evaluate the dysbiosis evolution.      Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up     consultations over a period of 6 months.   "
20991|NCT03010826|"     The neural circuits in our brains require a layer of insulation in order to transmit signals     in a rapid and efficient fashion. This insulation is called White Matter and is comprised of     a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs     following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and     cognitive problems. Currently there are no effective medical therapies to promote brain     repair and reduce disability following damage to white matter. In this project, we hope to     change the situation by encouraging the brain itself to generate new oligodendrocytes and     thus new white matter. Our first step is to find measures sensitive to white matter growth.   "
20992|NCT03010813|"     This is a prospective, single center, multispecialty study that aimed to evaluate the     clinical feasibility and safety of single port surgery and NOTES (mainly transanal and     transoral surgery) using a novel single port robotic system.   "
20945|NCT03011424|"     Early postoperative extracorporal liver support therapy (ELS) as a tool to manage post     hepatectomy liver failure (PLF).      Post-operative liver failure (PLF) has been identified as a major risk factor leading to     increased morbidity and mortality. The incidence of PLF varies largely between 0-30%, and may     be accounted for the main reason of postoperative mortality related to liver surgery     (reported figures ranging from 18 to 75 %).      Currently, there are only a few treatment options for PLF, mainly restricted to the treatment     of complications like bile leakage, infections as well as the prevention of further liver     damage caused by e.g. thrombosis or haemorrhage as well as administration of liver toxic     drugs. Recently the international study group on liver surgery (ISGLS) published criteria for     a new definition of PLF which will greatly facilitate the comparison of results from future     studies on a variety of aspects on liver failure.      ELS by using the Molecular Adsorbent Recirculating System (MARS) is based on a modified     haemodialysis that allows the removal of water-soluble and protein bound toxins over an     albumin-coated high flux membrane against recycled exogenous albumin. Thus, MARS can support     the compromised detoxification capacity of the liver as well as improve physiological     parameters. This would offer the potential for temporary support for the harmed liver after     liver resection allowing for a more uneventful recovery.      For obvious reasons previous reports contain few patients, present heterogonous treatment     groups and all suffer from lack of standardized treatment protocols. Few if any surviving     patients, thus providing no evidence to encourage ELS as a possible treatment option for     patients suffering of PLF. However, studies with defined patient populations and treatments     according to a predefined standardised treatment protocol are warranted.      Primary issues to be addressed:        1. Can ELS be applied in an early phase of PLF?        2. Is ELS safe and feasible for the treatment of PLF when practised according to a          predefined protocol?      Secondary issues to be addressed:        1. The development of predictive laboratory-chemical markers of liver failure        2. Indirect measures of portal flow and portal pressure        3. Indocyanine green clearance (ICG) under ELS treatment        4. Clearance of toxic products as assessed in aliquots taken from the dialysate   "
20946|NCT03011411|"     Pragmatic study comparing historical data from usual collection tools to medical     administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to the     data collection:        1. Collection of hospitalization data from the local PMSI and outpatient data from CRF        2. Collection of hospitalization data in the national PMSI with a probabilistic matching          between local and national PMSI data        3. Collection of outpatient consumption data from SNIIRAM after matching of data from the          national PMSI to the SNIIRAM.   "
20947|NCT03011398|"     The purpose of the Registry study is to observe the improvement in subject-reported clinical     outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.   "
20948|NCT03011385|"     OBJECTIVE: The project aims at investigating of the effects of three types of planning     (individual planning, collaborative planning, and dyadic planning) on physical activity among     dyads.The influence of three planning interventions are compared with an active control     condition, including physical activity education.      PARTICIPANTS: The effects of the interventions are evaluated among dyads of two adults     (partner-partner dyads). Adults forming dyads (e.g. two romantic partners, two relatives, two     co-workers, two friends) who are in regular contact for at least one year will be enrolled. A     minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The     interventions consist of six planning sessions.      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after     the first intervention session, at post-intervention (after six intervention sessions are     completed), and at 6-, and 12-month follow-ups.      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of     planning (individual, dyadic and collaborative) are secondary outcomes.   "
20949|NCT03011372|"     The purpose of this study is to evaluate the efficacy and safety of INCB054828 in subjects     with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1     rearrangement.   "
20950|NCT03011359|"     Colon resection is one of the major surgery, the postoperative pain is so severe that it is     necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The     most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively     insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce     the pain effectively. Consequently, it may result in the a lot of rescue analgesics use,     which leads to the adverse effects in patients who are very sensitive to narcotic analgesics.     And the patient's satisfaction to the PCA may be low.      For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode     setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out     time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a     new mode, so that the administered rate and amount of drug can be increased or decreased     according to the patient's use of bolus button. Therefore, this PCA device can be implemented     to the conventional mode, and added the function of automatically controlling the basal rate     and administered amount of drug according to the use demand of the patient. However, since     there are few studies related to this new mode of PCA, more research is needed in patients     with postoperative pain.   "
20951|NCT03011346|"     Transcatheter aortic valve implantation (TAVI) is an established treatment option for     patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic     valve replacement (SAVR). Many novel devices are currently being developed and established     transcatheter heart valves undergo design reiterations to address limitations and reduce     complication rates associated with the device and implantation procedure. However, device     comparisons by use of randomized trials are scarce in particular for newer generation     transcatheter valves. The aim of this study is to assess non-inferiority of the     self-expandable Symetis ACURATE neo/TF in comparison to the balloon-expandable Edwards SAPIEN     3 transcatheter aortic valve bioprosthesis with regard to early safety and clinical efficacy     at 30 days.   "
20953|NCT03011320|"     This study looks to enroll subjects with ovarian cancer who will be having standard of care     surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe     how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor     will also be studied. This study will also help us compare the amount of EC1456 seen in     tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission     tomography (SPECT) or single-photon emission tomography with in-line x-ray computed     tomography (SPECT/CT).      All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior to     EC1456 administration.      Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively:        -  4 mg/m2        -  8 mg/m2      EC1456 will be administered at 1 of the following 2 time points:        -  <8 hours before planned surgery        -  48±4 hours before planned surgery      Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again     right before surgery. At the time of surgery, tumor samples will be removed and sent to     Endocyte for analysis.   "
20954|NCT03011307|"     The purpose of this study is to determine the effect of intrathecal oxytocin on speed of     reduction in pain for the first 60 days after hip surgery.   "
20955|NCT03011294|"     Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact     not limited to the patients but also to the partner that sleep in the same bed. Is it     reasonable to speculate that the partner suffer sleep deprivation, increased level of     irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA     patient. Although previous data reported impaired sleep quality in partners of patients with     OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the     treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the     improvements in the subjective and objective sleep. Thus, the main objectives of this     randomized controlled study are: to evaluate the impact of three months of randomization     (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure     (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and     sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of     patients with moderate to severe OSA and a recent diagnosis of Metabolic Syndrome (MetS)     according to the ATP III criteria derived from an ongoing randomized study conducted in our     Institution.   "
20956|NCT03011281|"     The objectives of this single center, prospective, non-interventional inception cohort is to     understand patient characteristics, general treatment patterns, effectiveness, and safety of     Tofacitinib for rheumatoid arthritis patients in the real-world setting.        1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib        2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean          RA patients.        3. To further evaluate safety, effectiveness and demographic characteristics of the          patients treated with Tofacitinib matched with and compared to biologic DMARDs from the          BIOPSY registry database.   "
20957|NCT03011268|"     The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha     (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the     option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF     treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF     treatment after a relapse   "
20958|NCT03011255|"     Immunotherapy is now considered to be one of promising approaches for treating cancer.     Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal     cancer. Radiation-induced mutation genes were identified as new sources of tumor associated     antigens using exon sequencing and peptide microarray technologies. Epitope peptides for     these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this     clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL     therapy in combination with radiation therapy in treating patients with unresectable,     advanced or recurrent esophageal cancer.   "
20959|NCT03011242|"     The Investigators will examine if DC-STAMP can serve as an early marker of TNFi response in     PsA. Identification of such a biomarker would permit rapid transition to a new agent, a major     treatment advance. TNFi are the most effective therapies in PsA, however, methotrexate is     frequently initiated early in the disease course based on its significantly lower cost.     Unfortunately, the efficacy of MTX has not been supported in clinical trials and up to 40% of     patients do not respond to TNFi therapy. Moreover, valid biomarkers to predict MTX or TNFi     responses are currently unavailable. This study may also provide the first data on the     comparative efficacy of MTX and TNFi using clinical, Power Doppler Ultrasound (PDUS) and     biomarker outcomes.   "
20960|NCT03011229|"     The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic     ultrasound (EUS) biopsy needle to the current standard EUS needle.      The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is     possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60%     yield with the current needle.   "
20961|NCT03011216|"     The present study examines whether a computerized cognitive control training as compared to a     placebo (fake) training will reduce the frequency of depressive rumination in depressed     individuals. Rumination has been identified as a major risk factor for the onset and     recurrence of depressive episodes and it has been suggested that it is linked to deficits in     cognitive control functions. It is thus expected that training cognitive control will reduce     the frequency of rumination as well as ameliorate its detrimental effect on negative mood     states.   "
20962|NCT03011203|"     The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can     boost muscle mitochondrial function in vivo.   "
20963|NCT03011190|"     Borderline personality disorder (BPD) is the most prevalent personality disorder in young     community population whose most severe complication is suicide. Pharmacotherapy should not be     used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the main     treatment for people with BPD and the current recommendation is adapting available     comprehensive treatments to develop easier and briefer therapies that are also effective.     Iconic Therapy is an innovative option whose good clinical results should be validated on a     clinical trial.   "
20964|NCT03011177|"     To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 DM patients.   "
21111|NCT03009253|"     The purpose of this study is to find the best neoadjuvant therapy for pancreatic     adenocarcinoma.   "
20966|NCT03011151|"     Gastrointestinal (GI) dysfunction affects up to 50% of medical and surgical critically ill     children. GI dysfunction, specifically gastric dysmotility and loss of epithelial barrier     integrity, is associated with significant morbidity in critical illness. The mechanisms     underlying GI dysfunction in critical illness are not well understood. GI dysfunction in     surgery and critical illness has been associated with inflammation. There is evidence to     suggest the protease-activated receptor 2 (PAR2) is a link between inflammation and GI     dysfunction. PAR2 is a G-coupled receptor present throughout the GI tract. PAR2 mediates GI     motility and epithelial barrier integrity. PAR2 is activated by PAR2 agonists, specifically     GI serine proteases and zonulin, released under conditions of inflammation. In this study the     investigators will examine the relationship between inflammation and PAR2 activation by PAR2     agonists and subsequent GI dysfunction in pediatric critically ill surgical patients. The     overall hypothesis of this study is that PAR2 activation by PAR2 agonists, GI serine     proteases and zonulin, released due to inflammation results in gastric dysmotility and loss     of epithelial barrier integrity. In this study, the investigators will examine whether PAR2     agonist expression is increased and correlates with GI dysfunction in critically ill surgical     pediatric patients. This proposal fills a knowledge gap in the understanding of mechanisms     for GI dysfunction in critical illness, and will be applicable to all surgical and medical     critically ill children.   "
20967|NCT03011138|"     Previous reports have the evidence implicating gait velocity may affect kinematic parameters.     However, how the gait velocity will influence kinematic parameters remain unclear. The     purpose of this research is to find out kinematic characteristics among different gait     velocity. To do this, it will provide a reference for future prospective studies or     investigations and make us fully understand the impact of gait velocity.   "
20968|NCT03011125|"     This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase     1 clinical trial. This study will determine the safety and side-effect profile of an     investigational dexlansoprazole injection after single intravenous administration in healthy     Chinese adults.   "
20969|NCT03011112|"     There is little study focusing on kinematic parameters in the assessment of the symptomatic     and functional severity of knee osteoarthritis (KOA). The purpose of this study is to     evaluate the correlations between kinematic parameters and the severity of symptoms and     functions in patients with KOA.   "
20970|NCT03011099|"     The purpose of this study is to investigate whether robotic exoskeleton training can improve     walking performance after SCI as compared to conventional physical therapy.   "
20971|NCT03011086|"     The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had     been suggested as one of the factors but remains unproven.      The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients     to pave a way for new arena of treatment with the etiology of this persistent condition   "
20972|NCT03011073|"     Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system     has image processing and left ventricular function quantification software which are     different from the precedent model Philips IE33.Left ventricular function quantification and     myocardial distortion are the main medical examination influencing doctor's decisions.      EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial     distortion quantification software also has been modified with new cut off and different     calculation method.      The aim of this study is to compare the quality of images and the quantification of cardiac     ejection fraction with these new software in order to choose the more reliable and     reproducible for patient.   "
20973|NCT03011060|"     This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by     Capecitabine could achieve additional benefits over traditional postoperative chemotherapy.     In the study group, patients that do not achieve pathological complete response(pCR) will     receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group,     patients will be treated with postoperative adjuvant chemotherapy.   "
20974|NCT03011047|"     Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach     versus traditional trans-orbital surgical approach (control group) in orbital blow out     fractures in terms of postoperative clinical and digital radio-graphical assessments.   "
20975|NCT03011034|"     The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of     talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or     intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during     treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).   "
20976|NCT03011021|"     The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo     expanded umbilical cord blood regulatory T cells adjunct with Liraglutide on autoimmune     diabetes.   "
20977|NCT03011008|"     The purpose of this study is to investigate the therapeutic effect of Liraglutide on     autoimmune diabetes.   "
20978|NCT03010995|"     The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in     E-Cigarette users and also study the mechanism involved particularly with vascular     impairment.   "
20979|NCT03010982|"     This is a Phase 1, open-label, two-part study designed to characterize the PK of an IV dose     of approximately 12 µg tazemetostat that contains approximately 500 nCi of [14C] tazemetostat     and the ADME of an oral dose of 800 mg tazemetostat that contains approximately 400 µCi of     [14C]-labeled tazemetostat in three subjects with B-cell lymphomas.   "
21012|NCT03010553|"     Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a     99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along     with the other lymph nodes of the selective group II and III recess. Sentinel lymph node     staging alone and complete dissection with routine anatomical pathology will be compared If     this technique is reliable it will make a therapeutic de-escalation in the treatment of small     tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node     is free from metastasis and also to better choose the treatment in case of lymph node     involvement   "
21013|NCT03010540|"     Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate     Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone   "
20980|NCT03010969|"     The aim of the clinical study is:        1. to examine the association between postoperative endothelial function, indirectly          measured by reactive hyperemia index, and major adverse cardiovascular events including          myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal          surgery.        2. to examine the association between postoperative endothelial function, indirectly          measured by reactive hyperemia index, and non-cardiovascular complications including          non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.        3. to examine the importance of the postoperative blood glucose level and the pulmonary          function for postoperative complications and death within 30, 90 and 365 days of acute          abdominal surgery.        4. to examine the association between postoperative endothelial function, pulmonary          function and blood glucose level        5. the qualitative part of the study will examine the postoperative subjective symptoms          including acute and chronic pain, quality of recovery and functional status, depressive          thoughts and post-traumatic stress disorder.   "
20981|NCT03010956|"     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,     inflammation and elasticity. The purpose of this study is to investigate changes in arterial     stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes     mellitus type 1 or type 2 after glycemic control by optimal medication.   "
20982|NCT03010943|"     Feasibility and tolerance study of virtual reality headset for brain mapping during brain     awake surgery.   "
20983|NCT03010930|"     The purpose of this study is to determine how repeated dietary exposure to umami taste     affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult     subjects will consume a low glutamate vegetable broth daily for one month, where the     experimental group's broth is supplemented with the umami-rich stimuli of monosodium     glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).      The investigators hypothesize that repeated dietary exposure to umami taste will:        1. diminish umami suprathreshold intensity perception and hinder the ability to          discriminate varying MSG concentrations        2. decrease liking of umami-rich foods and shift preferences upwards towards more intense          umami stimuli        3. decrease satiation and decrease the satiating effect of a test meal   "
20984|NCT03010917|"     This project represents a first step in examining the potential use of fish oil for the     treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of     alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar     effects in healthy social drinkers.   "
20985|NCT03010904|"     This study aims to investigate differences in digestion rates and gastrointestinal problems     caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's     milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and     plasma cytokine levels.   "
20986|NCT03010891|"     The proposed 2-year study has two specific aims: (1) to examine the effects of a bundle of     supportive interventions on preterm infants' stress (salivary cortisol and     dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,     and physical activity in the NICU, and (2) to explore the relationships among preterm     infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,     and physical activity. This randomized controlled trial will adopt a longitudinal     repeated-measures design to examine the effects of bundled supportive interventions on     preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and     physiological signals of infant distress [using bedside electrocardiographic monitors]),     sleep and physical activity (using ankle actigraphy) during their NICU hospitalization.     Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two     conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine     kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive     interventions (usual NICU care +positioning + gentle touch + modulating infant states +     facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome     variables will include infants' biological responses to stress (salivary cortisol, salivary     DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.   "
20987|NCT03010878|"     This was a randomized control trial of a yoga and self-management intervention for     individuals with chronic pain. Participants were assigned to either a wait-list control group     (self-management only), or a yoga intervention (self-management and yoga). Self-management     education session occurred monthly within the community. Group yoga intervention was     delivered two times a week with a specifically designed program that was progressively more     difficult. Assessments were then administered pre and post intervention, and a     semi-structured interview was completed following the intervention. Quantitative and     qualitative data were then compared between groups.   "
20988|NCT03010865|"     The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment     for cognitive deficits in schizophrenia (SZ). The aims will be to evaluate its effects on     improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects     to epigenetic and inflammation related biochemical changes.   "
21015|NCT03010514|"     This is a national registry study to determine genetic risk factor and serial biomarkers of     thoracic aortic aneurysm/dissection   "
21041|NCT03010163|"     This study is divided into four groups. Group 1 includes Health Fairs implemented at NYC taxi     garage bases and airport taxi holding lots and pedometers. Group 2 includes Health Fairs,     pedometers and text messaging to facilitate walking and living a healthier lifestyle. Group 3     includes Health Fairs, pedometers and social network support. Group 4 includes Health Fairs,     pedometers, text messaging and social network support.   "
21031|NCT03010306|"     Building on an intervention for early child development from the SPARK Center in Boston,     Socios En Salud (SES) pilot tested CASITA a community-based package to screen and treat     young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in     Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays     within the clinics and community and delivered a structured early intervention that included     parent coaching and social support. In order to test the hypothesis that CASITA improves     early child development, caregiver, and home environment, dyads received either nutrition     supplements alone, nutrition + CASITA early child development sessions individually, or     CASITA in a group of 10 dyads.   "
20996|NCT03010761|"     No medication existed for BQ dependence. No clinical trials existed for the drug therapy.     Previous study showed that BQ possessed the antidepressant effect via pathway of monoamine     oxidase A (MAO-A). An animal model also found that the arecoline from BQ has a property as     MAO-A inhibitor. Therefore, the investigators hypothesized that inhibition of the MAO-A or     antidepressants might reduce the BQ addiction severity.      The investigators will conduct the randomization and double blinded with placebo controlled     study with 90 participants with BQ dependence from the Family Medicine and ear, nose, and     throat (ENT) outpatient department (OPD). All participants shall agree the informed consent.     The range of age is from 18 to 65 years old. The participants are diagnosed as BQ use     disorder without other psychiatry co-morbidity, according to the Diagnostic and Statistical     Manual (DSM)-V criteria. Those who have severe physical illness, psychiatric illness, and     other substance use disorder except cigarettes are excluded. All participants receive the     semi-structure interview by DSM-V, International Classification of Diseases (ICD)-10, and     Mini International Neuropsychiatric Interview by the psychiatrist. Before the intervention,     the participants will finish their basic data, daily amount of cigarettes, betel nut, medical     history and psycho-social rating scales. Next, in addition to counseling, the investigators     will continue or modify the optimal antidepressants based on the previous results.      The investigators will evaluate their BQ use condition as what has been measured in the     natural observation study of the first year. The investigators will check the outcome     measurement by visual analog scale, betel quid withdrawal severity scale, Yale-Brown     Obsessive-Compulsive (Y-BOCS) - betel quid (BQ) scale. The investigators also followed their     hamilton depression scale; Beck depression index; and Beck anxiety index in the baseline,     2nd, 4th, 6th , and 8th week. The investigators also obtained the participants' gene type if     the participants also agree for the prediction of oral cancers.   "
20997|NCT03010748|"     Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used     before and after clinical refractive surgery, we will collect the corneal morphological and     biologic parameters of the population under refractive surgery screening in refractive     surgery centers around the country, and construct corneal morphology database in different     living areas of Chinese people. Based on this, compared with the suspected keratoconus and     keratoconus population, the screening criteria and reference standards accord with the     characteristics of keratoconus of Chinese ethnic will be achieved.   "
20998|NCT03010735|"     The purpose of this study is to investigate the effects of oral administration of     Bifidobacterium animalis A6 on the metabolism of uremic toxins, in the patients with End     Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a     Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic     toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The     Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms     The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also     assessed.   "
20999|NCT03010722|"     This is a single centre prospective biological translational research study involving the     collection of tumour tissue, blood samples and clinical data from patients being treated with     regorafenib for metastatic Colorectal Cancer (mCRC) at the Royal Marsden Hospital. Patients     will be eligible for the study if they have a histological diagnosis of CRC, are refractory     to standard available therapies with palliative intent for mCRC, have received prior     treatment with at least one anti-VEGF antibody and chemotherapy drugs including fluorouracil     (5FU) or capecitabine, oxaliplatin and irinotecan, and patients have RAS mutant tumours.   "
21000|NCT03010709|"     Aneurysmal subarachnoid haemorrhage (aSAH) affects up to 10,000 individuals per year in the     UK. It accounts for ~5% of strokes, but is responsible for about 25% quality-adjusted life     years (QALYs) lost due to stroke. Although early repair of ruptured aneurysms and aggressive     postoperative management has improved overall outcomes, it remains a devastating disease with     mortality approaching 50%. Survivors are left with neurological injuries that range from     subtle cognitive deficit to disabling cerebral infarctions, less than 60% them returning to     functional independence.      SAH triggers a series of pathological processes resulting in neuronal damage and consequent     neurological deficit termed early brain injury (EBI). Many of the patients who survive the     initial bleed, deteriorate days later from delayed ischaemic neurological deficit (DIND),     which causes poor outcome or death in up to 30% of patients with SAH. Both of these     pathological processes are still poorly understood which limits the number of treatment     options.      DIND is treated with blood pressure augmentation to ensure adequate blood flow in the brain.     In awake patients, response can be easily and accurately assessed by performing a thorough     neurological examination. In patients whose clinical condition demands sedation, intubation     and ventilation, assessing response to treatment using the neurological examination is     virtually impossible. Multimodality monitoring (MM), primarily microdialysis and brain tissue     oxygen tension with catheters inserted into the relevant parts of the brain offer direct     assessment of both delivery and utilisation of metabolic substrates at the cellular level.     These can be used for early detection of DIND as well as monitoring during blood pressure     augmentation. The aim of this study is to establish and validate a clinical protocol for MM     derived management of SAH patients, to determine optimal therapies for correcting     abnormalities in brain metabolism and explore the relationship between MD and other     monitoring modalities.   "
21001|NCT03010696|"     The purpose of this study is to investigate the differences of gut Microbiome/Metabolite     between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis     patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.   "
21002|NCT03010683|"     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,     inflammation and elasticity. Agonists of Glucagon like peptide - 1 receptors (GLP-1R) used in     the treatment of type 2 diabetes mellitus (T2DM). This category includes exenatide and     liraglutide. These drugs lower glucose levels by inhibiting the secretion of glucagon,     promoting the release of insulin in response to hyperglycemia, slowing gastric emptying, and     augmenting satiety. Clinical studies have shown that GLP-1R agonists have beneficial effects     on cardiovascular function in both diabetic patients and healthy subjects. The purpose of     this study is to investigate in patients with T2DM without coronary artery disease (CAD),     patients with T2DM and CAD and obese patients with abnormal oral glucose tolerance test     (OGTT), changes in arterial stiffness, endothelial glycocalyx thickness and coronary reserve     flow (CFR) after treatment with metformin or agonist GLP-1R.   "
21016|NCT03010501|"     In this study, the investigators will vary the energy density of foods served during three     5-day periods. There will be a baseline condition, and then a condition where the energy     density of food is lower and a condition where the energy density of food is higher. The     primary aim is to determine the effect of varying the energy density of foods served over 5     days on energy intake in preschool children. It is hypothesized that mean daily energy intake     will be greater when children are served higher energy dense foods over 5 days than when     served lower energy dense foods over the same period. Additionally, it is hypothesized that     daily energy intake in the conditions with higher and lower energy densities will begin to     converge across the 5-day period.   "
21067|NCT03009825|"     The purpose of this study is to investigate the associations between lifetime exposure to     traumatic events, emotion regulation strategies, and eating pathology of patients with     obesity.   "
21003|NCT03010670|"     Among different social cues from the environment, the eyes constitute a very salient source     for initiating social interaction or communication. Interestingly, previous work from our     (Prinsen et al., 2016) and other labs demonstrated that direct eye contact between two     individuals can readily evoke an increased propensity to 'mirror' other peoples' actions.     Particularly, using transcranial magnetic stimulation (TMS), the investigators showed that     mirror-motor mapping at the level of the primary motor cortex (M1), also known as     interpersonal motor resonance (IMR), is significantly increased upon the observation of     actions accompanied by direct eye contact, compared to the observation of actions accompanied     by averted eye gaze.      With the present study, the investigators aim to investigate the role of eye contact on IMR     further, and in particular, explore whether administration of the 'prosocial' neuropeptide     oxytocin (OT) can influence eye-contact induced IMR. In general, OT is known to play an     important role in promoting prosocial behavior and the perception of socially-relevant     stimuli, such as eye gaze. To date however, the link between OT and IMR is less clear.   "
21004|NCT03010657|"     This study evaluates an eating strategy in adults undergoing chemotherapy for non-small cell     lung cancer. Subjects will be allocated to a randomized or observational arm based on     baseline measurements. In the randomized arm, half of participants will add certain foods to     what they normally eat, while the other half will continue to eat their habitual diet.     Subjects in the observational arm will continue to eat their habitual diet.   "
21005|NCT03010644|"     The consequences of childhood obesity are devastating, affecting the physical and mental     health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI     during the summer months and there is a dearth of information regarding the causal health     behaviors and environmental factors. The overall objective of this application is to provide     an in depth examination of key dietary and physical activity behaviors as well as the food,     physical activity, and social environments of low-income, racial/ethnic school-age children.     To achieve this goal, an observational study utilizing a multi-state prospective cohort     design will be conducted with the goal of examining the weight gain trajectory among a     racially and ethnically diverse convenience sample of disadvantaged school-age children who     routinely attend structured programming during the summer months and those who don't     participate in structured programming. In addition, a subset of these children will be     evaluated to learn their daily health behaviors, as well as their food, physical activity,     and social environments during the summer. Identification of determinants of program     participation and factors that may enhance the beneficial effects of program participation     will also occur. A social ecological framework approach will guide the research. This study     can be expected to have a significant positive impact by providing information on the factors     that protect disadvantaged children from unhealthy weight gain during the summer which can be     used by stakeholders at the local, state, and federal level to reform current policy that     will increase child participation in health promoting programming during the summer window of     risk.   "
21006|NCT03010631|"     A study to compare the pharmacokinetics and food-effect bioavailability of lubiprostone     sprinkle in healthy volunteers.   "
21007|NCT03010618|"     In recent years restoring carious of fractured primary teeth with stainless steel crowns     (SSC) has became more popular than ever. On the other hand the traditional operative approach     of complete removal of caries is steadily losing support due to successful results with     materials of high microleakage resistance.      Treatment time and pain control in asymptomatic teeth has always been a problem in children.     Hall technique is a minimally invasive treatment protocol that doesn't require local     anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.      But this protocol also raised questions in the scientific community about its possible     effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal     contact and increasing vertical dimension.      The aim of our research is to study the effects of Hall technique's premature occlusal     contact on TMJ.   "
21008|NCT03010605|"     Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for     return to optimum function. Traditionally, adequate range of motion has been achieved by a     combination of in-home and outpatient physical therapy. While physical therapy is successful,     it has the limitation of cost and availability. As copayments rise, patients may decide that     they cannot afford physical therapy, potentially compromising the outcome of their surgery     and successful return to function.      It is assumed that having an easy and fun to use, patient administered, incentive device that     provides accurate, quantitative flexion and extension measurements may accelerate patient     mobility and return to function after TKA. The Measuring Every Day (MED) portable goniometer     is commercially available and provides objective, consistent range of motion measurements     that are recorded and can be sent electronically to the clinician's office potentially     enabling earlier clinical or therapy adjustments or modifications to the prescribed therapy.      Goniometry is a commonly used tool to measure and document range of motion (ROM) during     clinical evaluation or a physical therapy examination. The technique is used to assess the     limitations of a patient's joint and provide information to the clinician that may help     determine further treatment.      The study is designed to compare range of motion measurement data for 6 weeks in patients     that have been randomized to receive either traditional physical therapy or the MED device.     The hypothesis is that patients who use the MED device achieve equivalent range of motion at     six weeks as compared to patients participating in traditional standard of care physical     therapy.   "
21009|NCT03010592|"     Studying the airway microenvironment in patients undergoing surgical and bronchoscopic     interventions for COPD   "
21010|NCT03010579|"     This is an randomized trial to evaluate the potential benefit of erythropoietin in the     treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell     transplantation.   "
21011|NCT03010566|"     Studying the microbiome of the lung in patients treated with endobronchial lung volume     reduction coils for emphysema   "
40883|NCT02750488|"     To evaluate the potential of a test material to produce a photoallergic response.   "
21154|NCT03008681|"     The aim of the study was to determine the changes in Oral Health-Related Quality of Life     (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint     (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex     group in which the functional therapy was most effective.   "
21017|NCT03010488|"     Previous data suggest some depressed patients act as if their internal biological clock is     out of sync with the outside world and re-aligning their clock with the timing of sunlight     lessens their depressed mood and accompanying depressive symptoms. This chronotherapy may     produce remission during the first week of treatment while causing minimal problems. This     study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for     inducing sleep phase advance. Which chronotherapy condition a participant will receive will     be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to     determination of which protocol a patient will follow, each patient will declare their     desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific     times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned     sleep times will differ between groups using different strategies to shift the timing of     their sleep from their ideal sleep time as determined by their Morningness-Eveningness     Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily     by telephone for the first week following randomization, and then weekly for an additional     five weeks. Whenever possible, weekly visits will be in person, although telephone visits     will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an     Independent Evaluator blind to treatment assignment (as well as the nature of the treatment     and if it has occurred or not). After the six week post-randomization evaluation, all     participants will be offered six months of continued treatment and be rated monthly.     Treatment during this six month period may consist of Chronotherapy or conventional     antidepressants as the patient and doctor determine. Standard ratings of depression, over-all     illness and functioning will be obtained. Change in the symptom measures will determine     treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data     will measure the timing of the biological clock and whether it has been shifted by the     treatment. Measures of functioning will determine whether functioning improves coincident     with, independent of, or subsequent to mood improvement.   "
21018|NCT03010475|"     This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral     semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.   "
21019|NCT03010462|"     A prospective, multi-center, randomized, sham-controlled, blinded study combining active     Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized     task oriented rehabilitation will be conducted in patients with post-stroke motor impairment     of the upper limb. The therapy will be provided for 6 weeks and primary outcome assessed 6     months later.   "
21020|NCT03010449|"     A single arm pilot study of lung volume reduction in severe emphysema using bronchoscopic     autologous blood instillation in combination with intra-bronchial valves.   "
21021|NCT03010436|"     Benralizumab is a type of medicine called a monoclonal antibody that is made in the research     clinic; it works by blocking a specific protein in the body called interleukin-5. The study     medicine, benralizumab, is not yet approved for doctors to treat patients with EGPA. It is     considered an experimental drug in this study.   "
21022|NCT03010423|"     The study is a single-center, interventional, pilot study to evaluate the improvement of     microvascular function by positron emission tomography (PET) after twelve-week treatment of     oral nicorandil in female non-obstructive CAD subjects.   "
21023|NCT03010410|"     Aging is associated with immunosenescence and impaired host defense mechanisms, contributing     to influenza-related morbidity and mortality. Preliminary data demonstrate that the platelet     transcriptome is markedly different between healthy subjects and influenza patients.     Interferon-induced transmembrane proteins (IFITM) family members are among the transcripts     significantly increased in platelets during influenza and expression of IFITM-3 is impaired     in elderly subjects, a pattern associated with increased mortality. This study will build on     these data and investigate if aging influences the expression of platelet IFITM family     members in patients with influenza and sepsis.      This study will prospectively determine if aging alters the induction of (IFITMs) in     platelets from hospitalized influenza and sepsis patients. The study will also determine if     diminished expression of IFITM family members correlates with an increased risk of adverse     outcomes in older influenza and sepsis patients.   "
21024|NCT03010397|"     Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes     (PROGRESS)   "
21025|NCT03010384|"     The aim of this study was to investigate the impact of a rehabilitation program including a     physician specialized in social medicine parallel to treatment for suspected spinal disc     herniation.   "
21026|NCT03010371|"     This multicenter study aims to prove the efficacy of a pilot psychosocial evidence-based     treatment (Positive Psychotherapy) in two formats (online vs face-to-face) with an online     support control group. It develops as a randomized-controlled trial in a group of primary     breast cancer survivors assigned to one of the three experimental treatments. The principal     dependent variables assessed will be emotional distress, post-traumatic growth and QoL. Some     treatment predictors of psychosocial response will be explored. Lastly, an economic analysis,     comparing the three psychosocial treatments and focused on the quality adjusted life years     (QALY) will be made. It is expected to find higher efficacy in psychosocial indicators and     QALY for Positive Psychotherapy in the two experimental intervention formats than in the     online support group. It is hypothesized that the face-to-face format will be more effective     for severely distressed patients with previous history of trauma, while the online format     will be more effective for younger patients with mild emotional distress.   "
21027|NCT03010358|"     This phase I/II trial studies the side effect and best dose of entospletinib when giving     together with obinutuzumab and to see how well they work in treating patients with chronic     lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that has come back.     Entospletinib may stop the growth of cancer cells by blocking some of the enzymes need for     cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of     cancer cells to grow and spread. Giving entospletinib and obinutuzumab together may work     better in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or     non-Hodgkin lymphoma.   "
21028|NCT03010345|"     patient receiving treatment using the osmed expander will have enough soft tissue coverage     securing the bone graft which will be placed in a later stage to close the alveolar cleft.   "
21029|NCT03010332|"     This is an expanded access protocol designed to provide access of ATA230 to subjects with     cytomegalovirus (CMV) viremia or disease, who are intolerant to, or failed, standard     antiviral therapy and have no comparable treatment options.   "
21030|NCT03010319|"     The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of     diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care     treatment. Half of patients will be treated using PriMatrix while the other half will receive     Standard of Care treatment.   "
21068|NCT03009812|"     The Aim of the study is to compare between transverse and longitudinal uterine incision in     abdominal myomectomy regarding intraoperative blood loss.   "
40884|NCT02750475|"     To determine the phototoxic potential of a topically applied article in human subjects   "
21032|NCT03010293|"     Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or     after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe     complication with a poorly known management, and is associated with a high rate of relapse,     leading to a high-burden in hospital bed-days, financial cost, surgical intervention,     antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone     and joint infection management, the medical and surgical strategies are systematically     discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical     strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction     using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to     evaluate this complex approach and to determine risk factors of treatment failure in order to     improve patient management, focusing on optimization of empirical antimicrobial therapy after     each surgical stage, delay between the two surgical stage, and duration of antimicrobial     therapy.   "
21033|NCT03010280|"     A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric     bypass will be performed. Patients will be randomly assigned into 2 groups: those patients     receiving a preoperative balanced energy high-protein formula (group 1) and those receiving     preoperative Immunonutrition (group 2). Preoperative weight loss, postoperative septic     complications and analytical acute phase reactants will be investigated.   "
21034|NCT03010267|"     A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics     of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each     component administered alone in healthy male volunteers.   "
21035|NCT03010241|"     Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2     diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases     the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than     60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have     some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We     postulate that patients with DSPN will benefit from therapy with TCM treatment according to     syndrome differentiation.      Methods and design: A randomized, double-blind, placebo-controlled and multi-centric clinical     trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the     inclusion criteria were randomly divided into two groups. The patients in the study group     were treated with Tangbi prescription, and the patients in the control group were treated     with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases.Major     evaluation indicators: Changes in Clinical Symptoms and Signs in Distal Symmetrical     Polyneuropathy patients.The clinical symptoms and signs of patients were recorded by Michigan     Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS)     were compared between the two groups before and after medication. Secondary Evaluation     Indicators:① nerve conduction velocity changes, The changes in nerve conduction velocity of     each nerve were compared before and after taking medicine.② Clinical symptoms and signs     change, The clinical symptoms and signs of the patients were compared before and after taking     the medicine.      Discussion: We postulate that patients with DSPN will benefit from therapy with TCM     treatment.   "
21036|NCT03010228|"     Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy     adults below 40 years of age.      180 subjects will be enrolled in 6 treatment groups (different doses; different formulation:     with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid     region on Days 0, 28 and 56. Study participants will be followed up until one year after     first vaccination.   "
21037|NCT03010215|"     Despite the development of the control of DM and the great interest for the complications of     the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon.     Being frequently correlated to alteration of the plantar pressures, the surgery treatment is     recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this     pathologic case.      The purpose of this longitudinal cross-sectional study was to evaluate radiographic and     surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis     of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic     through MIS.   "
21038|NCT03010202|"     This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance     therapy may prolong the the effect of Rituximab in immune thrombocytopenia.   "
21039|NCT03010189|"     Cluster headache is one of the most painful headaches, characterized by recurring episodes of     unilateral, periorbital pain, which is accompanied by autonomic symptoms that seem to be of     both sympathetic and parasympathetic origin. The pathophysiology behind the condition is     largely unknown, but increasing evidence indicate that the hypothalamus plays a pivotal role.     The headache attacks come in clusters or bouts (hence the name) which last up to three     months, after which the headache disappears for at least one month. 10-15% have chronic     cluster headache. During attacks, the patients have cranial sympathetic hypoactivity and     parasympathetic hyperactivity, whereas they have cranial parasympathetic hypoactivity during     remission phase. There is an emerging hypothesis that headache attacks are elicited in a     state of autonomic hypoarousability, which is also supported by the fact that most cluster     attacks occur during the night, when the patients are sleeping.      The aim in this project is to study the intercept between the sleep-wake cycle, autonomic     tone and the occurrence of headache attacks, by using actigraphy, heart-rate variability and     pupillometry. All these methods are well validated, and frequently used in studies on sleep     and autonomic function. The study design is that of a case-control model where 15 cluster     headache patients will undergo pupillometry, before wearing the actigraph and heart-rate     variability-monitor for two weeks, once in cluster bout and once in remission phase. The     actigraphy will register nocturnal movement and sleep quality, and headache attacks will be     registered by pressing a button on the actigraph. The pupillometry measures pupillary     constriction and dilation in response to light, a reflex that is controlled by the autonomic     nervous system. The heart-rate variability monitors fluctuations in the heart rate which     reflects the sympathovagal balance of cardiac control. All participants will fill out the     Pittsburgh Sleep Quality Index before and after registration. In addition, 15 healthy     controls will undergo one session of the same examinations. The results of the study will     give valuable insight to the pathophysiology of a condition that is very painful and has     great impact on the patients' quality of life, and also add knowledge to the relation between     headache, sleep and the autonomic nervous system.   "
21042|NCT03010150|"     The goal of this clinical research study is to learn about the reasons head and neck cancer     patients may or may not follow the swallowing exercises that they are asked to perform after     receiving radiation treatments. Researchers also want to learn if certain levels of cytokines     affect if participant has side effects and if it puts participant at risk for future disease.     Cytokines are proteins that are related to the immune system.   "
21155|NCT03008668|"     The investigators plan to undertake a rigorous multicentre randomised controlled trial,     comparing acupuncture on sensitized acupoints versus non-sensitized acupoints, to test if     acupuncture on sensitized acupoints may result in improved treatment outcomes in patients     with Knee osteoarthritis (KOA).   "
21043|NCT03010137|"     Incisional negative pressure therapy (INPWT) has previously been shown in certain patient     populations to decrease wound healing complications, decrease the rate of hematomas and     seromas, as well as have better scar quality. We have found a group of patients, those who     have panniculectomies in preparation for renal transplant, with significantly higher rates of     wound healing complications. We believe the best way to demonstrate benefits of incisional     negative pressure wound therapy will be in this group of patients known to have significantly     higher rates of wound complications.   "
21044|NCT03010124|"     The investigators therefore propose to conduct a biological study of prospectively collected     patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical     smear) throughout the disease course where markers (at diagnosis and their change with     treatment) will be correlated to outcome in order to investigate how genetic diversity in OC     prior to treatment and adaptation following treatment contribute to chemotherapy resistance.     In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex     vivo DNA repair functional assays and isolated in primary culture (and established as     xenografts) for target validation experiments.   "
21045|NCT03010111|"     The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using     whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean     health care workers.   "
21046|NCT03010098|"     To investigate the effect on older's cognition of the application of closed target-controlled     infusion(TCI) of propofol and remifentanil guided by Narcotrend index .   "
21047|NCT03010085|"     Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional,     prospective and randomized trial in patients undergoing left sided hepatectomy through     laparoscopic versus open procedure.      Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood     loss, operation time, resection margin status, postoperative complication, mortality, liver     function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness   "
21048|NCT03010072|"     This is a single-center, prospective, open-label, controlled, randomized, cross-over study in     34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with     hyperphosphatemia.   "
21049|NCT03010059|"     The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by     measuring ALS-008112 plasma concentrations following administration of a single oral dose of     JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to     their respective current formulations under fasted conditions and to assess the effect of     food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy     adult participants.   "
21050|NCT03010046|"     This is a single-center, randomized, double-blind, placebo-controlled, ascending,     single-infusion, sequential group study. Single, ascending doses will be administered to     approximately 56 subjects, with an option for 1 additional multi-dose cohort in approximately     8 subjects. The primary objective is to evaluate the safety of ANX005 administered as an     intravenous infusion as a single agent and in combination with intravenous immunoglobulin     (IVIg). The optional multi-dose cohort will evaluate either additional subjects at the     maximum tolerated dose or ANX005 administered as 2 infusions.   "
21051|NCT03010033|"     It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative     complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary     rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the     effect and long-term results of pulmonary rehabilitation on smoker patients have not been     studied. The purpose of this study is to determine whether pulmonary rehabilitation is     effective to smoker patients who underwent lobectomy.   "
21052|NCT03010020|"     The investigators propose to develop and pilot an HIV prevention intervention based on rectal     STI testing, counseling, and treatment for MSM in Peru. The investigators will use nucleic     acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial     (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and     single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling     (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological     outcomes including changes in levels of inflammatory cytokines following rectal STI. The     intervention is based on three interrelated objectives: 1) To use periodic rectal STI nucleic     acid testing to identify the members of the MSM population at greatest short-term risk for     HIV infection; 2) To provide single-dose antibiotic treatment to control the immune     activation and mucosal inflammation caused by rectal GC/CT infection that increase cellular     risk for HIV transmission; and 3) To use Personal Cognitive Counseling (PCC) to understand     and modify recent high-risk sexual practices that led to rectal STI acquisition and that     increase future HIV risk.      The investigators propose to screen 750 behaviorally high-risk MSM for rectal GC/CT infection     to enroll 100 GC/CT-positive individuals (using a conservative 15% prevalence estimate) and     50 GC/CT-negative controls (matched by age and baseline frequency of URAI). GC/CT-infected     participants will be given single-dose antibiotic therapy and randomized to receive     single-session PCC (n=50) or standard post-test counseling (n=50). The primary outcome will     be the impact of PCC on self-reported sexual risk behavior (URAI). Secondary outcomes will     assess: 1) Feasibility/Acceptability of the STI screening program; 2) Impact of GC/CT     infection and treatment on levels of inflammatory cytokines (IL-6, IL-8, TNF-αand IL-1β) in     rectal mucosa; 3) Prevalence of persistent/recurrent rectal GC/CT; and 4) HIV incidence in     GC/CT-infected and -uninfected MSM.   "
21053|NCT03010007|"     Influenza associated illness has a global annual impact with high morbidity and mortality.     Transmission mechanisms and rates are under-investigated and overall poorly understood.      This project aims to use epidemiological tools to understand the transmission and evolution     of influenza viruses at an individual and population level within a small-scale city (Basel)     through a combination of experimental, clinical and mathematical advances. The investigators     aim to quantitatively characterize the viral transmission using novel     molecular-epidemiological tools based on whole genome sequencing.   "
21069|NCT03009799|"     This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in     decreasing the number of days where adenoviral conjunctivis is detected in the eye and in     reducing the duration and/or the severity of the signs and symptoms of adenoviral     conjunctivis   "
21083|NCT03009617|"     Through the training and consultation program conducted via the web for health promotion,     which is an important part of a school's healthcare, interactive communication methods     between school nurses and students were provided. The results of the study showed that     web-based education and counseling positively influenced health promotion behaviors of the     students, and e-health literacy and their knowledge was increased.   "
21114|NCT03009214|"     This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation     study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose     (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will be     determined after completion of Part 1 considering safety and tolerability, also beyond the     dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD) results.   "
21054|NCT03009994|"     Cesarean section is one of the most frequently performed major operations worldwide. It     accounts for between 1% and 70% of deliveries depending on the facilities or country     assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private     hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut     university is 51.3% of all deliveries.      Different Operational techniques For cesarean section have been defined aimed at reducing     surgical time, making the surgery easier and more efficient, lowering costs,decreasing the     risk of adverse effects and postoperative morbidity, as well as length of hospital stay.      Also, Intraoperative blood loss is one of important complications during cesarean section. A     systematic review included twenty one studies, in 2011, revealed that increase incidence of     intraoperative blood loss and blood transfusion with increase number of cesarean     deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative     blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of     pregnant women.      After baby born by cesarean section and the placenta has been extracted, uterine incision is     sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization     of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal     cavity (in situ repair). There had been few randomized controlled trials comparing     intraoperative and postoperative morbidity following exteriorization of the uterus with     non-exteriorization. The conclusions drawn from these trials have been conflicting.   "
21055|NCT03009981|"     This is a randomized, open-label, three-arm, phase 3 study in men with biochemically     recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.   "
21056|NCT03009968|"     After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients     requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute     retention experience urinary tract infections in the postoperative period (6, 7). Many women     consider being discharged with a Foley catheter to be a surgical complication and describe     catheter use as the worst aspect of their surgery(8). At this time there is no consensus     within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best     assess voiding function postoperatively. FPMRS providers both within the United States and     around the world utilize a variety of void trial methods and varying criteria to determine     adequacy of post-operative voiding efficiency (5).      The traditional backfill assisted void trial method involves the assessment of a postvoid     residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently,     there have been efforts to determine ways to avoid the assessment of a PVR as it is     time-consuming and potentially exposes the patient to additional catheterizations (9, 10).     Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead     utilize a certain voided volume threshold to determine adequate voiding. However, to date, no     one has directly studied this approach or compared the traditional backfill assisted void     trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating     a more efficient void trial method, the investigators hope improve patients' postoperative     experience and reduce catheterization and risk of urinary tract infection (UTI).      This study aims to compare two void trial methodologies in order to help standardize     post-operative care in the urogynecology population. This study also has potential to lead to     an overall change in our field and improve the postoperative course for women across the     country and abroad.   "
21057|NCT03009955|"     To everyone knows, more and more patients received repeated caesarean section in China.     However, at present it is not known what is it like about their postoperative pain intensity,     and is it different from those patients who received primary caesarean section. Thus through     postoperative follow-up, the current study aimed to investigate and compare the postoperative     pain between patients received primary and repeated caesarean section.   "
21058|NCT03009942|"     This study evaluates the nitric oxide and arginase levels in patients with dental implants.     Peri-implant sulcular fluid and saliva samples were collected after loading of the implants   "
21059|NCT03009929|"     Whereas there are several validated systems for reporting postoperative complications, there     are only a few and not prospectively validated systems for reporting intraoperative     complications. The investigators developed a definition and CLASSification for Intraoperative     Complications CLASSIC within a Delphi study involving international interdisciplinary     experts. As both surgery and anaesthesia may be involved in complications in the     perioperative period, all patient-related intraoperative complications occurring between skin     incision and closure are considered in this reporting system.      The aim of this international multicentre observational cohort study is to assess the     validity and practicability of this newly derived classification system CLASSIC in patient     undergoing an in-hospital surgical procedure. Providing an easy applicable and     internationally validated classification system is a contribution to improve quality of     health care and patient safety.   "
21060|NCT03009916|"     The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and     glucose homeostasis, both with and without bile acid sequestration.   "
21061|NCT03009903|"     This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes     bacteria and phage strains using pore strips on up to 400 human subjects.   "
21062|NCT03009890|"     Objective: to compare the functional outcome after open reduction and internal fixation with     non-operative cast treatment for elderly patients with displaced intra-articular distal     radius fractures.   "
21063|NCT03009877|"     Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient     population. This study will examine whether Optiflow can do this, and compare the     pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.   "
21064|NCT03009864|"     This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2     diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to     evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited     for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal,     and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment     with either tang shen prescription or placebo.   "
21065|NCT03009851|"     The goals of the proposed research were to:        1. describe the person and environment characteristics and activity patterns of residents          in long-term care (LTC) facilities;        2. modify the evidence-based, occupation-based cultural heritage intervention (OBCHI)          grounded on the results of Aim 1;        3. test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into          LTC facilities relative to a usual activities group;        4. determine the cost-effectiveness of the intervention conducted by in-house staff          compared to the control group; and        5. examine person and environment factors as potential moderators of the relationship          between treatment condition and adaptation outcomes.   "
21066|NCT03009838|"     Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate     is the most commonly used oral agent for ovulation induction in this group, but there are     some drawbacks with the use of it.   "
21070|NCT03009786|"     The main objective of this study is to achieve cross-cultural and psychometric validation of     the Xerostomia Inventory initially developed in English language into French Language. This     will be achieved in two stages: First, cross-cultural validation, and a second, psychometric     validation The cross-cultural validation will be performed according to the methodology of     the Institute for Work and Health, according to the recommended six phases. In a second step,     the psychometric validation will be done using longitudinal study. Indeed, an observational,     longitudinal, and prospective study will be set up. Analysis of the results will help define     the feasibility and acceptability of the tool, its validity (content validity, perceived     validity, construct validity, concurrent validity, and discriminant validity), its     reliability (internal consistency and reproducibility over time). Longitudinal follow-up of     patients is expected to also assess the predictive validity and responsiveness.   "
21071|NCT03009773|"     Stroke is the leading cause of severe disability in adults. The first cause of alterations in     the quality of life and autonomy in these patients are disorders of walking and the balance.     They are the leading cause of falls responsible for important medical, surgical and economic     complications as well as a reactionary social isolation.      The techniques of rehabilitation of walking to the subacute phase of a stroke are usually     based on automatic walking.Off walking is a complex activity usually performed in everyday     life in association with multiple tasks. It is therefore interesting to re-educate walking in     dual task or even in multitasking.   "
21072|NCT03009760|"     The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420     after single and multiple dose administration according to H. pylori infection.   "
21073|NCT03009747|"     This research plans to collect rectal cancer patients after sphincter-preserving surgery from     14 institutions in China mainland, observe the incidence and risk factors about bowel     dysfunction after operation.   "
21074|NCT03009734|"     AntibioTx is developping ATx201 as a topical product for treatment of skin infections,     including infected atopic dermatitis.   "
21075|NCT03009721|"     The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in     patients with essential hypertension and dyslipidemia   "
21076|NCT03009708|"     Traditionally known for their role in haemostasis, platelets have also an immune role.      Platelets play a key role in immune mediator secretion, and interact with innate and adaptive     immune cells, contributing to the fight against pathogens, as viruses.      Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of     the induced immune depression. Platelets activation for patients is not determined during the     post-graft period, and platelet induced inflammation following a CMV infection is not     described.   "
21077|NCT03009695|"     Obesity is a metabolic disease that has reached epidemic proportions. Insofar no long-term     effective drug treatment was developed for obesity. Lyfe style modulation and bariatric     surgery are the only interventions with a limited rate of success. Obesity is due to several     factors, mainly linked to a neurophysiological mechanism of food addiction. The use of     repetitive deep Transcranial Magnetic Stimulation (dTMS) was proposed to reduce appetite and     food craving in obese subjects, leading eventually to a weight reduction. dTMS was already     tested successfully in other forms of addiction (smoking, alcohol, cocaine) and the     usefulness of dTMS in the treatment of food addiction, and therefore in obesity, was     hypothesized. End-points of this research will be: 1) effect on food craving; 2) acute and     chronic effects on blood level of hormones acting on the appetite regulation; 3) chronic     effects on body weight. The demonstration that a safe, non-invasive and repeatable     methodology can treat obesity reducing food craving and modulating appetite/satiety hormones     secretion will constitute a cornerstone in translational medicine of metabolic diseases.   "
21078|NCT03009682|"     This study is a single arm, multi-center phase II study of olaparib monotherapy in patients     with relapsed small cell lung cancer (SCLC) harboring BRCA 1/2 mutations, ATM deficiency or     MRE11A mutations as second or third line chemotherapy.      Target subject population:      Patients with small cell lung cancer that have progressed following first-line platinum-based     therapy. Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC     treatment, which must have contained platinum-based regimen, with at least one measurable     lesion per RECIST 1.1.   "
21079|NCT03009669|"     To assess the value of using pleth variability index(PVI) to monitor the patient's     intra-operative volume status continuously by observing the application of stroke volume     variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor     surgeries.   "
21080|NCT03009656|"     The emergency setting for acute neurological conditions, such as stroke, is peculiar due to     time pressure and limited resources for further diagnostics. Clinical skills are essential     for swift and accurate bedside diagnosis and thus are the basis for early and correct     treatment. This is especially evident in the context of computed tomography being the     standard neuroimaging method world-wide with its limitations for detecting smaller infarcts,     strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic     seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by     neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not     been studied in detail. In order to improve clinical diagnosing and future treatment it is     essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting     (how good are neurologists?) and to assesses whether there are any differences between     experienced staff neurologists and junior physicians.   "
21081|NCT03009643|"     Hypoxemia is a common complication after aortic surgery. As this complication has an adverse     effect on the postoperative course of the patient, early treatment is important; however, the     mechanism of hypoxemia after surgery for acute aortic dissection remains unclear. Recently,     the investigators found that inhaled Nitric Oxide can improve the oxygenation in some of     these patients. The investigators are trying to evaluate the effectiveness and safety of     inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.   "
21082|NCT03009630|"     The objective of the study was to evaluate the efficacy and safety of electromagnetic     navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of     early-stage peripheral lung cancer.   "
27712|NCT02922998|"     The purpose of the study is to find out whether CD64 expression on neutrophils measured by a     new bedside test (LeukoDx) within 30 minutes is associated with effective antibiotic therapy     in critically ill adult patients at risk of sepsis.   "
21085|NCT03009591|"     Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds,     especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints,     causing a progressive joint deterioration. Secondary disorders to this joint degeneration     include: biomechanical alterations, loss of range of movement and periarticular muscle     atrophy.      Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a     treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of     the elbow.      Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in     patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with     hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients     will be recruited in 6 centers, from different regions of Spain.      Intervention: Each session will last approximately 50 minutes, with three physiotherapy     sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers     that must be administered bilaterally:      Measuring instruments and study variables: goniometric evaluation (range of movement); visual     analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire     (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the     same time, the study will allow to determine joint bleeding caused by applied physiotherapy     treatment.      Expected results: First, it is intended to demonstrate the safety of this physiotherapy     technique in patients with hemophilia. Likewise, an improvement in the perception of elbow     pain and joint mobility is expected. An improved functionality of the upper limb is also     foreseen and with it, an enhanced perception of quality of life of these patients.   "
21086|NCT03009578|"     Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive     ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated     pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care     programmes in numerous developing and underdeveloped nations.      Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum     period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due     to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and     postpartum hemorrhage are important causes of postpartum anemia   "
21087|NCT03009565|"     Background: The human gastrointestinal system is populated with a variety of symbiotic     microorganisms, namely microbiota. The microbiome is the total genetic data of the     microbiota. The human gut microbiota interacts extensively with the host through metabolic     exchange; thereby contribute to a variety of metabolic and immunologic mechanisms in the     human body. Coronary artery disease (CAD) is major cause of morbidity and mortality worldwide     and is a major field of interest in microbiota research. There have been several findings     that connect the gut microbiota to CAD pathophysiology, but these data relates solely to the     interaction between human gut microbiome and cardiovascular risk factors. As far as known ,     data regarding patients who already developed CAD is lacking.      Aims: To investigate gut microbiota of patients with CAD, thereby allowing the adjustment of     personalized treatment by changing the pro-atherosclerotic environment in the gut.      Methods: Study participants will include patients arriving to Rabin Medical Center with     suspected CAD. Patients will provide medical, lifestyle, and nutritional questionnaires.     Vital signs measurements will be taken as well as fecal samples and/or rectal swabs. Blood     samples will be drawn to measure blood chemistry including lipid profile and     trimethylamine-N-oxide (TMAO) levels. Patients will undergo cardiac CT and/or cardiac     catheterization in accordance with the decision of the cardiologist to evaluate and/or treat     CAD. Genomic DNA will be extracted from stool samples for Microbiome analysis.      Innovation: The hypothesis is that there is a unique microbiota pattern in patients with     coronary atherosclerosis, which may contribute to the pathogenesis and/or expression of CAD.     Knowing the unique microbiota in patients with coronary disease, would render it as novel     target for treatment, either primary or secondary prevention.      Collaboration: Between Cardiology department at Rabin Medical Center and the lab of Prof.     Eran Segal located at the Weizmann Institute of Science. The collaboration between these two     groups will combine the clinical expertise of treating cardiac patients with novel scientific     technology and concept.   "
21088|NCT03009552|"     The overall objective of the study is to determine whether speckle tracking echocardiography     presents additional prognostic value to the routine assessment (clinical and     echocardiographic) in patients admitted with acute decompensated heart failure (ADHF) at the     emergency department. Specific objectives: 1 - To evaluate the association between changes in     the cardiac contractile mechanics (by serial measurements of strain, strain rate,     displacement velocity, rotation and ventricular torsion) with clinical outcomes in ADHF. 2 -     Evaluate the possible association of these parameters with biomarkers of neurohormonal     activity, myocardial injury, fibrosis and myocardial remodeling, inflammatory activity, and     cardiorenal syndrome.   "
21089|NCT03009539|"     The purpose of this study is to test the relative effectiveness of a Hispanic-specific     eHealth intervention, e-Health Familias Unidas, in preventing and reducing drug use, sexual     risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited     through four pediatric primary care settings. Pediatric staff and research team members,     including nurse assistants and mental health professionals, will implement eHealth Familias     Unidas.   "
21090|NCT03009526|"     This study aims to compare the efficacy of monthly IPTp-DP with monthly IPTp-SP to determine     if IPTp-DP is associated with a reduction in malaria infection at delivery among HIV-negative     women in an area with high levels of SP resistance in Malawi.   "
21091|NCT03009513|"     An open label, one sequence study to investigate the pharmacokinetic drug interaction between     Teneligliptin and Glimepiride in healthy male subjects   "
21092|NCT03009500|"     The purpose of this study is to evaluate three different injectable solutions used to block     ankle nerves to manage ankle pain. The current standard of medical care is to inject a     combination of local anesthetics and steroids around injured nerves. There is evidence that     injection of local anesthetic (without the steroid) can calm the injured nerve and provide     pain relief from a few days up to a few months. Injection of sterile salt water also has the     potential to provide pain relief by breaking scar tissue around the nerve thereby relieving     compression. Injections of local anesthetic and steroids around injured nerves have been used     for many years to provide relief of pain but the specific reason is not well known for this     benefit.      There are three possibilities: 1) Steroids can reduce inflammation and calm the nerves, 2)     local anesthetics can have similar actions but with shorter duration (few days), and 3)     injection of any solution can break scarring around an injured/compressed nerve.      The study will compare pain relief and possible adverse effects from these three different     solutions. This study will help provide definitive answers regarding pain relief and possible     adverse effects of the three solutions. This, in turn, will determine the best possible     option for injection in patients with nerve-related injury pain.   "
21093|NCT03009487|"     A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy     and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with     concomitant hypertension and hyperlipidemia   "
21094|NCT03009474|"     To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and     Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.   "
21112|NCT03009240|"     This phase I trial studies the side effects and best dose of pevonedistat when given together     with decitabine in treating patients with high risk acute myeloid leukemia. Pevonedistat and     decitabine may stop the growth of cancer cells by blocking some of the enzymes need for cell     growth.   "
21095|NCT03009461|"     According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib     is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT),     but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not     benefit much from sorafenib in previous studies. There is no established standard treatment     for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to     investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy     (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with     Major Portal Vein Tumor Thrombosis.   "
21096|NCT03009448|"     Analysis of recent studies show that researchers find it hard to distinguish between Late     Onset Depression, a first diagnosed major depressive episode which occurs at old age, and     Early Onset Depression, a depressive episode at old age with a history of previous episodes.     Since current data, about the phenomenology and etiology of Late Onset Depression, lake     conicity it is unclear whether this phenomena should be considered as a distinct subtype of     depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a     stronger correlation with brain damage and environmental risk factors such as the common     losses at old age and weaker correlation with family history and genetics when compared to     Early Onset. Although many researchers consider brain damage to have the main contribution to     the emerge of Late Onset Depression, the fact that depression has a negative effect on one's     health supports the claim that it might be the result and not the rick factor. Since Late     Onset Depression correlates with the common losses at old age, the investigators propose that     an existential approach that deals with one's meaning, freedom, responsibly and death, might     be more appropriate. Thus, the investigators ask how do older adults experience depression     which they face for the first time in old age? Current study will seek to understand older     adults' experience of Late Onset depression through existential paradigm by using a semi     constructed interview.   "
21097|NCT03009435|"     Introduction:      The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in     which 5% remain occiput posterior at the end of labor. Occiput posterior position is     associated with higher risks of caesarean deliveries and operative vaginal deliveries. The     manual rotation to promote rotation from a posterior to an anterior position has been     proposed to reduce the extraction rate. There is no randomised trial comparing the effect of     manual rotation and expectant management. We propose a protocol for a prospective,     monocentric, randomised controlled clinical trial in order to show that the rate of     spontaneous vaginal delivery is higher with manual rotation of occiput posterior position     than with an expectative management.      Methods:      Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position     suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible.     Participants will be randomised to either prophylactic manual rotation (experimental group)     or expectative management (control group). Based on an alpha value of 0.05 and gaining 20%     for spontaneous vaginal delivery, 238 participants will need to be enrolled.      The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be     operative delivery rate (caesarean section , vacuum or forceps deliveries), significant     maternal and perinatal mortality/morbidity.      Analysis will be by intention-to-treat averaging a 24-month period.   "
21098|NCT03009422|"     The investigators will compare the common treatment for cutaneous leishmaniasis with     intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.      Outcome will be final scar appearance assesd by two dermatologist and pain measurement by     VAS.   "
21099|NCT03009409|"     Closed-loop control of anesthesia involves using feedback from a measure of clinical effect     to continuously adjust drug infusion rates. As a result, anesthetic drugs are delivered at a     variable rate that is frequently personalized to each individual patient. The aim is to     provide greater stability at an optimal depth of anesthesia, reducing the occurrence of     under- or overdosing, with the goal of ultimately improving patient outcomes.      The purpose of this randomized, controlled equivalence trial is to compare controller     performance during closed-loop controlled induction and maintenance of total intravenous     anesthesia, using iControl system, with the addition of a low (analgesic) dose of ketamine     versus saline control.   "
21101|NCT03009383|"     The purpose of this study is to determine whether a bedside portable endoscopy is effective     in identifying the esophageal foreign body in the emergency room.   "
21102|NCT03009370|"     The purpose of this study is to determine whether ovarian reserve is related to recurrent     pregnancy loss   "
21103|NCT03009357|"     The study is a single-center prospective cohort study of clinical application of continuously     monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose     of the study is to evaluate the association between parameters of pulse rate, activity, and     sleep from wearable activity trackers and the thyrotoxic status along with the treatment.   "
21104|NCT03009344|"     This is a multicenter, single-arm, open-label, Phase 1 study to assess the tolerability,     safety, pharmacokinetics, and preliminary anti-tumor activity of tazemetostat in participants     with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).   "
21105|NCT03009331|"     The study comprises two different objectives. Longitudinal description of postoperative     pulmonary dysfunction in the cardiothoracic surgery patient, and the comparison of two     different lungrecruitment strategies.   "
21106|NCT03009318|"     MRS and 11C-MET PET/CT are commonly used as supplementary imaging techniques for the     differential diagnosis of non-enhancing supratentorial gliomas. However, both techniques have     limitations leading to misdiagnosis; therefore, the investigators attempted to combine these     two metabolic imaging tools to evaluate whether the combination of MRS and 11C-MET PET/CT can     increase the sensitivity of the radiological diagnosis of non-enhancing supratentorial     gliomas.   "
21107|NCT03009305|"     The study aims to describe hemodynamic effects of lower body negative pressure (LBNP).        1. If and how changes in cerebral oxygen saturation (StO2) measured by near infrared          spectroscopy (NIRS) relate to changes in blood flow in the carotid arteries during          progressive LBNP.        2. If and how mean systemic filling pressure (MSFP) can be measured by brief occlusion of          blood flow to an arm and if this relates to LBNP-level.        3. If and how pulse pressure variations and photoplethysmographic amplitude variations          during positive expiratory pressure (PEP) and continuous positive airway pressure (CPAP)          relate to LBNP-level.   "
21115|NCT03009201|"     This phase Ib trial studies the side effects and best dose of the CDK4/6 inhibitor ribociclib     when given together with doxorubicin in treating patients with soft tissue sarcomas that has     spread to other places or that cannot be removed by surgery. Ribociclib may stop the growth     of sarcoma tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving ribociclib for a week prior to standard treatment with doxorubicin may work     better in treating patients with soft tissue sarcoma.   "
21116|NCT03009188|"     Axenfeld-Rieger syndrome (ARS) is a rare autosomal dominant disorder, characterized by     anterior segment abnormalities and systemic abnormalities. To date,two major genes, forkhead     box C1 (FOXC1) on chromosome 6p25 and pituitary homeobox 2 (PITX2) on chromosome 4q25, have     been demonstrated to cause ARS. In this study, we performed complete ophthalmologic     examinations and analysis of FOXC1 and PITX2 of a Chinese family with ARS.   "
21117|NCT03009175|"     The purpose of the study is:        -  To evaluate the Heart Failure Risk Status (HFRS) feature performance.        -  To establish the feasibility of remote follow-up in which patient risk triaging is          performed by nurse-led review of HFRS feature as supplemental information.   "
21118|NCT03009162|"     This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose     study.      This study will enroll up to 32 subjects using an adaptive design that can include up to 3     groups of 8 subjects with different degree of renal impairment and one group of 8 control     subjects with normal renal function.      Screening data will be reviewed to determine subject eligibility. Subjects who meet all     inclusion criteria and none of the exclusion criteria will be entered in the study.      First, approximately 16 subjects will be enrolled with severe renal impairment and matched     subjects with normal renal function. There will be 8 subjects in each of the following groups     based on renal function at screening:        -  Group 1: Healthy subjects with normal renal function (eGFR ≥ 90 mL/min/1.73m2)        -  Group 2: Severe renal impairment subjects (eGFR < 30 mL/min/1.73m2) Based on safety and          pharmacokinetic (PK) results from subjects with severe renal impairment (Group 2), Group          3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be enrolled if          substantial change in the exposure of lasmiditan is observed in subjects with severe          renal impairment.   "
21119|NCT03009149|"     H1 - Aerobic exercise will expect to experience significant increase on CD4 counts , reduced     viral load , improve psycho-social well being among people living with HIV /AIDS.   "
21120|NCT03009136|"     The aim of this study is to investigate the short and long term efficacy and the safety of     SCRT treatment for PAR   "
21121|NCT03009123|"     The rationale for investigating the hypothesis that there is an association between erectile     dysfunction (ED) and the subsequent development of prostate cancer is based on three     assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in     men with prostate cancer; 2) the development of ED and prostate cancer may have certain     shared common risk factors; and 3) the use of testosterone for the treatment of ED has been     suspected to be associated with prostate cancer development. Controversy exists over whether     men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated     the risk of developing prostate cancer for men with ED. The investigators, therefore,     conducted a population-based longitudinal study with eight years' follow-up to examine this     association and to evaluate the magnitude of the risk.   "
21122|NCT03009110|"     The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large     pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness,     safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a     closed, sealed system that applies negative pressure to the wound surface via a single-use,     battery-powered, portable device - to decrease surgical site infections (SSIs) in obese     women.   "
21123|NCT03009097|"     Periodontitis is a major oral health problem which leads to the progressive destruction of     periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate     goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common     form of regenerative periodontal therapy is the use of bone grafts which stimulate bone     formation by the processes of osteoinduction and osteoconduction.      Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of     the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of     BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti     oxidant properties.      Very few studies exist evaluating the beneficiary effects of grafts if combined with the     statins which might enhance the regeneration by bone grafts.      Hence, the present study was carried out in an attempt to comparatively evaluate clinically     and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the     treatment of intrabony defects.   "
21124|NCT03009084|"     The purpose of this study is to investigate the communication and data sharing between the     primary care physician and the nephrologist about patients with chronic kidney disease. Also     therapeutic interventions that change behavior and telemonitoring of the blood pressure will     be explored and compared to the usual care. The most important aim of this study is to     improve the quality of care for the patient with chronic kidney disease in cooperation with     the primary care physician and the nephrologist.   "
21125|NCT03009071|"     A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical     effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture     for chronic neck pain patients compared to acupuncture alone.   "
21126|NCT03009058|"     During this open label study patients will receive IMM-101 in conjunction with a recognised     standard of care for metastatic or unresectable cancer for the patient's specific tumour     type.      The primary objective of the study is to provide safety data for IMM-101 in combination with     a number of selected standard of care regimens.   "
21146|NCT03008785|"     This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have     greater effects on climacteric symptoms than exercise alone in postmenopausal women. the     participants will be randomly assigned to the group: placebo and exercise or 100mg of     isoflavone and exercise.   "
21127|NCT03009045|"     The problem of interest is that doctors are looking for new antibiotic treatments for bone     and joint infections. Treatment for bone and joint infection is not standardized, which     allows a wide range of antibiotic therapy to potentially be given. A type of bacteria called     S. aureus is the most common cause of bone and joint infection. Methicillin resistant S.     aureus (MRSA) is a type of bacteria that is not killed by some antibiotics, and it is     increasingly common in U.S. and non-U.S. medical centers. This problem will be studied by     investigating whether an antibiotic called tedizolid is tolerable, safe and effective to     treat bone and joint infections.   "
21128|NCT03009032|"     Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a     greater risk of clinical progression. Gut bacteria metabolism appears to impact immune     recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and     probiotics seem to exert immunological effects, the clinical implications in this key     population remain unknown. This is a pilot multicenter randomized placebo-controlled, double     blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS.     Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341     or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be     safety and immunological recovery. Secondary outcomes will include changes in fecal     microbiota structure and plasma inflammatory markers.   "
21129|NCT03009019|"     Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being     conducted at multiple centers in the United States   "
21130|NCT03009006|"     The aim of this prospective in vivo randomized clinical trial to evaluate influence of     combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2%     (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste,     Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and     reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted     necrotic teeth.      According to the inclusion criteria the patients enrolled in the study and allocated randomly     into three groups either combination of calcium hydroxide paste intracanal medication with 2%     chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B)     or mechanical preparation without intracanal medications (group C) the endodontic treatment     is done at two visits.      The samples of endotoxin divided into three groups: after access (S1), after mechanical     instrumentations (S2), after removal intracanal medication (S3), all samples taken by a     sterile paper points introduced in the root canal for the working length for 60 seconds.      firstly the patient's medical and dental history is taken. the patients assign on informed     consent. and then anaesthetized and access cavity performed and root canal preparation is     done by Revo-s system then irrigation and intracanal medication placement inside to canal.     the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2     weeks after first visit. the operator will recall the patient to check the records      second visit After 2 weeks from application of ICM, rubber dam will be applied then removal     of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals     after irrigation and removal of the remnants of the intracanal medicament with the saline     solution.        -  Removal of the paper sample to determine the endotoxin concentration.        -  The canals will be obturated by single cone technique using gutta percha point tapered          0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final          apical size of the file and the root canal sealer will be resin sealer (Adseal, META          BIOMED CO., LTD, Korea).        -  Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first          visit (at the day of the Obturation) before the beginning of Obturation.   "
21131|NCT03008993|"     INTRODUCTION Our group previously demonstrated the feasibility of the Hucare Quality     Improvement Strategy - HQIS, aimed at integrating into practice 6 psychosocial interventions     recommended by international guidelines. This randomized trial is designed to assess whether     the introduction of the strategy in oncology wards improves patient quality of life.      METHODS AND ANALYSIS This is a multicenter, incomplete stepped-wedge cluster randomized     controlled trial, where the intervention strategy is sequentially carried out in three groups     of centers (clusters with 5 centers each) and in three equally spaced time periods (epochs)     (every 4 months). The study also includes an initial epoch during which none of the centers     is exposed to the intervention, and a final epoch when all centers will have implemented the     strategy . The intervention is applied at a cluster level (unit of randomization) and     assessed at an individual level with cross-sectional model. 720 patients will be included,     i.e. 60 patients in each cluster for every detection epoch.      Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of     improvement of at least one of two domains of HRQoL using the EORTC QLQ-C30 questionnaire,     detected at baseline and 3 months after enrolment.      The HQIS comprises three phases: 1) clinician training - to improve communication-relational     skills and to instruct on the project; 2) center support - 4 on site visits by experts of the     project team, aimed to introduce the project and boost motivation, instruct staff on how to     implement recommendations, help with context analysis and identification of solutions; assess     actual implementation in the center; 3) implementation of EBM recommendations.      ETHICS AND DISSEMINATION Ethics committee review approval has been obtained from the Ethics     Committee of Parma. Results will be disseminated at conferences, in peer-reviewed and     professional journals intended for policymakers and managers.   "
21132|NCT03008980|"     Patients will be recruited from participating institutions prior to planned routine care EGD     with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who     are potentially eligible for the study will be approached regarding the study. If interested,     participants will be consented and proceed with routine care EGD. The study coordinator or     other research personnel will document information from the routine care endoscopy as part of     this research study. Follow-up information collected will include WATS3D cytology and forceps     biopsy pathology results from any routine care endoscopy performed during the course of     participation in the study, any surgeries received and related to their condition, and any     other care received as part of their condition. WATS3D samples will be sent to CDx     Diagnostics for analysis.   "
21133|NCT03008967|"     This project will be a descriptive, hypothesis-generating study. The aim is to identify risk     factors for poor response to rehabilitation programs after TJR and use these to identify     patients who are most susceptible to poor outcomes in order to optimise appropriate     rehabilitations strategies and rationalising the distribution of health care resources.   "
21134|NCT03008941|"     Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to     contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with     nutritional interventions exert limited immunologic effects, but a deep understanding of how     these interventions could ameliorate gut dysbiosis and influence health among HIV-infected     individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on     effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio<1     will be included and randomized to either repeated low-dose oral fecal microbiota     transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary     outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio,     inflammatory markers, T cell activation and markers of enterocyte barrier function through     week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the     V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint     will be studied by combination of untargeted mass spectrometry and two different and     complementary separation techniques in bacterial and plasma samples.   "
27869|NCT02920944|"     This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore     needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore     needle. The study design is prospective, randomized study.   "
21135|NCT03008928|"     New technologies offer potential ways to provide and deliver preventative interventions. With     respect to unhealthy alcohol use, offering people tools to assess and manage their risk at     any given time using their smartphone may represent an additional opportunity to disseminate     preventative interventions. Nevertheless, there is a lack of knowledge on the acceptability     and efficacy of smartphone applications for unhealthy alcohol use. Alcooquizz, a smartphone     app, has been previously evaluated using a before/after design without randomization, with     participants reporting reductions in drinking over time. The current trial proposes to     conduct an RCT, comparing reductions in alcohol consumption between participants provided     access to Alcooquizz to a no intervention control.      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential     participants identified as problem drinkers based on an initial survey will be invited to     complete another survey in 6 months time. Those who agree to be followed-up will be     randomized to be provided a link to download the Alcooquizz app or to a no link control     condition. At six-months post-baseline, the MTurk portal will be used to send invitation     emails that contain a link to the follow-up survey that asks about their drinking and their     impressions of the app. The primary hypothesis to be tested is that participants receiving     access to the Alcooquizz app will report a greater level of reduction in number of drinks in     a typical week between the baseline survey and six-month follow-up as compared to     participants in the no information control condition.   "
21136|NCT03008915|"     The aim of this study is to test whether aspirin improves endothelial function in alpha-1     antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood     flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.   "
21137|NCT03008902|"     We are studying how spine movement changes with age, and when people have vertebral fractures     (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).   "
21138|NCT03008889|"     The purpose of this study is to demonstrate the feasibility of a 9-week, randomized trial of     N-acetylcysteine (NAC) compared to placebo in 14 children (age 5 to 12 years) with Autism     Spectrum Disorder (ASD) and a moderate level of repetitive self-injurious behavior (SIB).     Additional aims are to evaluate the positive predictive value of a screening method to     classify children with automatically maintained self-injurious behavior; to evaluate the     preliminary efficacy of NAC for reducing repetitive SIB in children with ASD; and to evaluate     biomarkers and possible mechanisms of action of NAC in children with ASD.   "
21139|NCT03008876|"     This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV     ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm     infants.   "
21140|NCT03008863|"     1. The investigators will design, test and implement a education curriculum for anesthesia          residents teaching geriatric anesthesiology.        2. The investigators will randomize 42 anesthesia residents so that half receive an          innovative, e-learning curriculum while the other half receives the current standard          curriculum. We will assess their medical knowledge, and the amount of anesthesia          delivered to patients after the curriculum is implemented.        3. The investigators will analyze any changes in clinical practice of residents in the care          of elderly patients. Enrollment will be voluntary for all residents. Also, the          investigators will not interfere with clinical management of any patients by residents          which are done under direct supervision of faculty.   "
21141|NCT03008850|"     Shivering is a common post-anesthetic complication occurring in up to 65% of patients     undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram,     blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen     consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result     in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could     therefore result in better postoperative outcomes or reduce the incidence of post-surgical     complications.   "
21142|NCT03008837|"     Given recent increasing opioid-related deaths and evidence showing against the use of opioids     for non-malignant chronic pain, there is growing need for non-narcotic pain management.     Fibromyalgia is a difficult to treat chronic pain condition that is often treated with     opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans     returning from the gulf war and is already a significant burden in senior Veterans who may     have suffered with chronic pain for decades already. Many treatment options for fibromyalgia     carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a     FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA     system, but sufficient evidence regarding its outcomes and neural mechanisms have not been     adequately investigated. An understanding of its neural underpinnings and analgesic effects     could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3)     development of new techniques to address pain.   "
21143|NCT03008824|"     There is a rapidly escalating epidemic of obesity and type 2 diabetes across the world, with     the fastest rise occurring in low- and middle-income countries. India not only has one of the     highest rates in the world, but the disease starts at a younger age and lower levels of body     weight than in UK white caucasians. Among city-dwelling Indians, approximately 8% of people     aged 30-40 years already have diabetes. This is creating a heavy burden of disease and     disability, and an intolerable economic burden through medical costs and lost earnings. Until     now, efforts to prevent diabetes have mainly focussed on modifying the diet, lifestyle and     activity of at-risk adults (for example those who are overweight, have a family history of     diabetes or already have high blood sugar). However, recent research has indicated that     factors acting in early life (during development in the womb) place an individual at risk of     later diabetes. These include maternal malnutrition and low birthweight, and diabetes in the     mother during pregnancy. Our research has shown that Indian mothers often have low vitamin     B12 levels, which in turn causes high blood levels of a harmful metabolite (homocysteine). We     have shown that these mothers get more diabetes in pregnancy. Their children are more likely     to born with a low birth weight, and develop more body fat and higher plasma insulin levels     during childhood, which are signs of higher diabetes risk in later life. The risk is     increased further if the mother has normal or high status for another B vitamin, folate.     Thus, we have shown, for the first time a link between a specific nutritional deficiency in     the mother and diabetes risk in the next generation. One possible mechanism for the effect of     maternal nutrition on risk of diabetes in her children is through epigenetic effects, whereby     the nutritional environment during early development affects the switches that control gene     expression. Since these switches are passed on via either parent, we think it is possible     that paternal vitamin B12 status could also be important.   "
21144|NCT03008811|"     This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon     catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment     of patients with persistent or longstanding persistent atrial fibrillation.   "
21147|NCT03008772|"     To define the long-term incidence and frequency of ISR follow DES implantation. Compare the     clinical presentation, treatment and intervention success among de novo coronary artery     stenosis and DES ISR.      Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR,     assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days,     6 months, 1 year, 3 years, and 5 years, if available.   "
21148|NCT03008759|"     The literature recognizes that fluoride is the most widely used and studied means for dental     remineralization. The use of fluoride toothpaste in brushing is considered more rational     method for the prevention of caries. However, the current challenge of toothpaste is the     substantivity, so new compounds have been introduced into these formulations. This study aims     to evaluate the in vivo effect of fluoride dentifrice containing nanoencapsulated Fluoride     (Nano-F) - in fluoride retention in saliva and dental plaque. A study of the clinical and     laboratory type, crossover, double-blind, randomized will be held. After sample calculation,     the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and     filled teeth index less than 6 and residents in brazilian northeast capital will be part of     the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the     use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after brushing; and     unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3     toothpastes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium     fluoride. Between weeks of use, brushing will be extended washout (without fluoride) to avoid     carryover effect. inferential data analysis will be carried out, considering the amount of     alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in     the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re     process and in the control of dental caries   "
21149|NCT03008746|"     Pseudomonas aeruginosa (PA ) is associated with chronic lung infections in patients with     chronic obstructive pulmonary disease (COPD). Commensal flora (microbiota) in lung was     recently described using high-throughput sequencing techniques (NGS). PA strains isolated     during lung infection episodes of severe COPD patients often show resistance to antibiotics     including imipenem that is mainly due to mutation in oprD. In collaboration with Harvard     Medical School, the investigators have recently demonstrated that PA OprD mutant shows     increased survival (fitness) and its virulence. This bacterium could be more likely to     colonize. Colonization by PA OprD mutant could influence the pulmonary microbiota and may     worsen disease evolution, particularly in terms of frequency of exacerbations. Our objective     is to describe modification of pulmonary microbiota associated with PA colonization,     including OprD PA mutant, in severe COPD patients. The investigators will correlate the     microbiota modification to medical history. Stable severe COPD patients will be included.     Three groups of patients will be sampled: 1) not PA colonized, 2) PA colonized and 3) PA OprD     mutant colonized. Medical history will be recorded by the physician as usual and three     samples will be performed: 1) sputum, 2) oral wash and 3) water used for oral wash. Regular     bacterial culture will be performed and NGS will be performed also to characterize the     microbiota.   "
21150|NCT03008733|"     The use of nerve ultrasound for the diagnosis and monitoring of neuromuscular diseases is a     promising growing field (1). Non-invasive and painless, ultrasound provides additional data     electroneuromyography (EMG), with a spatial resolution at least as good as MRI, while being     easily accessible and inexpensive.The polyradiculoneuritis Inflammatory Demyelinating     Chronicles (IPDC), Neuropathies Motrices in Multifocal Conduction Blocks (NMMBC) and     neuropathy associated with anti-MAG antibodies are among the major chronic inflammatory     neuropathies with an autoimmune etiology. The diagnosis of these pathologies is based on the     clinic, diagnostic tests and EMG. The interest not only in the diagnosis, but also for     monitoring these pathologies using ultrasound analysis nerves has been demonstrated recently     in several studies. However the limited resolution of current ultrasound images do not allow     detailed study of the internal structure of the nerves which could later help deepen     knowledge in this innovative field and can better understand the pathophysiological mechanism     of the evolution of these pathologies .      To do this, the investigators have available a UHF ultrasound in the ultrasound department of     the Nice University Hospital Pasteur Hospital 2 The investigators realize a descriptive     analysis study, pilot, mono-centric, multi and prospective on patients followed in the center     with a diagnosis of IPDC, a NMMBC or neuropathy with anti-MAG antibodies and control subjects     matched by age and sex. All the patients and controls in this study will receive a briefing     and must sign an informed consent.      They realize an ultrasound study of the nerve, using an ultra high frequency ultrasound     system that will allow the assessment of anatomical structures of nerve (size, structure,     vascularisation and assessment booklets). Ultrasound data will, in a second stage, compared     with the data obtained with the EMG and clinical scores obtained using clinical rating     scales. 40 subjects will be included, divided into four subgroups: 10 subjects with a     diagnosis of IPDC (1), 10 subjects with a diagnosis of NMMBC (2), 10 subjects with a     diagnosis of neuropathy antibody-anti MAG (3) and 10 control subjects with no signs of     neuropathy at the EMG examination.   "
21151|NCT03008720|"     Introduction: It is suggested that increased cortical activity, induced by cerebral     stimulation associated or not with other rehabilitation techniques, may potentiate the motor     and functional therapeutic effects in individuals with neurological deficits. Objectives: To     evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of     individuals with hemiparesis due to stroke following treatment with transcranial direct     current (tDCS) stimulation and functional electrical stimulation (FES), associated or     isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both     of which were collected at four different time points: pre-treatment, immediately after 10     treatment sessions, and 30 days follow-up after the interventions. Patients will be     randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction     TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active     contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over     the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and     FES over hemiparetic TA by a researcher who will not be the one who will evaluate the     anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20     minutes.   "
21152|NCT03008707|"     Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative     to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD)     (Modified Hinchey's classification grade II non responder to conservative therapy and grade     III). Aim of the study is to evaluate wha surgical strategy, between LPL and LS could give     better results in patients with CAD   "
21153|NCT03008694|"     This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning     in oral Cancer patients. Progress-free survival (PFS) will be compared with historical     control as defined in the protocol   "
24158|NCT02969447|"     Prospective randomized trail which compare 2 regimens for third-stage management after second     trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional     medication after fetal expulsion. Primary outcome was the incidence of placental retention.   "
21156|NCT03008655|"     BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results     from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid     both showed efficacy on the treatment of melasma. However, no combination therapy of both be     reported.      OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low     influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection     for melasma.   "
21157|NCT03008642|"     The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has     been used in the vast majority of studies in sport medicine. However, this method has never     been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The     standard procedure to evaluate the red cell mass is based on isotopic measurement using     Cr51-labelled red cells, but its lack of availability in many centers highlights the need for     a non-invasive and rapid alternative method. The purpose of this study is to evaluate and     validate the CO-Rebreathing method in this set of indications.   "
21158|NCT03008629|"     Background: Ingrown toenails are one of the most frequent nail disorders and can be treated     with conservative or surgical approaches. Although discovered a long time ago, the available     data are still very limited on the potential effectiveness of nail braces for ingrown toenail     treatment.      Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix) for     treatment of ingrown toenails.   "
21159|NCT03008616|"     This study evaluates the use of Digoxin immune fab in addition to expectant management in the     treatment of severe preeclampsia as compared to placebo.   "
21160|NCT03008603|"     This is a prospective, single-arm study is to evaluate the safety, effectiveness and     usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous     procedures in the interventional radiology suite, e.g., core biopsy, will participate in the     summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will     also be evaluated.   "
21161|NCT03008590|"     Over 100 million Americans report chronic pain. Veterans are disproportionately affected for     multiple reasons, including injuries and post-traumatic stress disorder. Treatment for     chronic pain is a priority research area for the VA. One of the most common causes of chronic     pain is osteoarthritis (OA). OA is attributable to wear and tear, but reasons for pain are     complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect 2-3% of     persons and require treatment with immune-suppressive drugs to prevent joint destruction.     Pain often persists despite effective treatment. Pain in arthritis results from multiple     sources: inflammation, perception of pain in the joint, and interpretation of pain by the     brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose     naltrexone is a widely used but unproven alternative approach to chronic pain. It is     attractive for study because it is safe and is proposed to work on all three pathways that     contribute to pain. A small but high-quality clinical trial is needed to determine whether to     invest in definitive studies.   "
21162|NCT03008577|"     Neonatal hypothermia is associated with increased risk of mortality as well as multiple     morbidities. The prior HEAT study conducted at our institution showed a difference in     neonatal hypothermia with a change in ambient operating room temperature. The investigator's     objective is to determine if an increase in ambient operative room temperature decreases the     rate of neonatal morbidity. Operating room temperature will be randomized to the current     institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for     a period of 1.2 years.   "
21163|NCT03008564|"     There has been dispute about the location at which the adductor canal block should be     performed (3-6). Two Common approaches have been used for ultrasound guided adductor canal     blocks with the 'point of entry' being:        1. Point A: midway point between the ASIS and base of patella        2. Point B: Point which is 2-3 cm proximal to the site where the femoral artery becomes the          popliteal artery as it traverses away from the sartorius muscle towards the femur at the          adductor hiatus (2)      We want to determine ultrasound anatomy in healthy volunteers by:        1. Measuring the distance between Point A and Point B        2. Studying the ultrasound anatomy at Point A and B - Determine their location with respect          to the adductor canal and femoral triangle.      This will allow us to determine which is the best site for performing an adductor canal block   "
21164|NCT03008551|"     This a randomised open-label parallel study involving women with polycystic ovary syndrome     (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg     daily for three months. The aim of the study is to examine the effect of empagliflozin on     hormonal, metabolic and cardiovascular risk markers and quality of life in women with PCOS.   "
21165|NCT03008538|"     Studying the comparative effectiveness of socket preservation using autogenous bone graft     versus MPM for implant insertion.   "
21184|NCT03008291|"     Participants in this study will either have heart failure (HF) and are scheduled to undergo     cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy     defibrillator (CRT-D) implantation, or have atrioventricular (AV) block and are scheduled to     undergo dual chamber pacemaker implantation. In this study additional heart rhythm     measurements will be collected during the implant procedure to better understand how His     bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of     patients with HF or AV block.      The hypothesis is that His bundle or parahisian pacing (HISP) may normalize atrioventricular     (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in     functional bundle branch block or conduction delay in patients with heart failure (HF).   "
21331|NCT03006354|"     In this prospective, randomised clinical trial the investigators aim to assess if nasal high     frequency oscillatory ventilation (nHFOV) could be used as the primary modality of     respiratory support in late preterm and term infants with transient tachypnea of the newborn     requiring non-invasive ventilation.   "
21186|NCT03008265|"     Nationwide cohort study on short- and long-term mortality of patients with and without     postoperative fascial dehiscence.      The cohort will be comprised of patient undergoing open colonic resection for colonic cancer     registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence     and the outcome of interest 30-day, 3- and 5-year mortality.   "
24198|NCT02968927|"     To examine the safety and preliminary efficacy of multiple adjunctive host directed TB     therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent     permanent lung damage.   "
21166|NCT03008525|"     Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including     calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a     hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family)     leading to the production of the 25(OH)D, which corresponds to the circulating form of the     VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the     kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous     epidemiological studies reported an inverse relationship between obesity and circulation     level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese     subjects, the more classical evoked being based on sequestration and/or dilution of VD in     adipose tissue (AT), the main VD storage site. However, this mechanism has never been     demonstrated. In order to confirm this hypothesis, the concentration of VD and its     metabolites in adipose tissue need to be quantified.      The objective of this study is to determine the concentration of VD and its metabolites in     adipose tissue as well as adipose tissue mass quantification and distribution (visceral or     subcutaneous) to highlight putative difference of VD and its metabolites quantities between     obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid     metabolism gene expression will be realized on biopsies. Correlations between gene expression     and quantity of VD in tissue will be carrying out.   "
21167|NCT03008512|"     This study evaluate activity and safety profile of weekly Genexol-PM in patients with     advanced hepatocellular carcinoma for whom sorafenib treatment failed. Patients will receive     Genexol-PM on days 1, 8, and 15 every 4 weeks.   "
21168|NCT03008499|"     The aim of this study is the safety and efficacy of high-activity natural killer     immunotherapy to small metastases of colorectal cancer.   "
21169|NCT03008486|"     The purpose of this study is to assess the effects on upper limb spasticity of soft splints     worn during three weeks three hours a day by patients with stroke or disorders of     consciousness.   "
21170|NCT03008473|"     Glidescope and chest CT iminge for the placement of the Univent Tube Without Fiberoptic     Bronchoscope Assistance   "
21171|NCT03008460|"     The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic     sulphate-based laxative preparation given on the day before colonoscopy has non-inferior     efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in     adolescents aged 12 to 17 years (inclusive) with a body weight >40 kg, scheduled to undergo a     colonoscopy for a routinely accepted diagnostic indication.   "
21172|NCT03008447|"     E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change     from baseline in postural stability (worsening) when participants are awakened at     approximately 4 hours postdose is significantly less after lemborexant than after zolpidem     tartrate extended release following a single-dose administration at bedtime.   "
21173|NCT03008434|"     This long-term goal of this project was to advance best practices in occupational therapy in     conjunction with yoga. To address the long-term goal, this research team developed a pilot     yoga intervention. The intervention was designed to focus on balance, balance confidence,     body responsiveness, pain, physical ability and quality of life. Assessments were then chosen     to address these areas pre and post yoga intervention. A manual and protocol were developed     for the intervention and then the intervention was implemented with a group of individuals     with chronic traumatic brain injury.   "
21174|NCT03008421|"     In the present study, the investigators aim to evaluate the potential of oral probiotics,     containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group     B Streptococcus (GBS) during pregnancy. This could help to prevent neonatal morbidity and     mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as     early-onset or late-onset GBS infection.   "
21175|NCT03008408|"     The goal of this clinical research study is to learn if the combination of everolimus,     letrozole, and ribociclib can help to control recurrent (has returned after treatment) or     progressive endometrial cancer. The safety of this drug combination will also be studied.   "
21176|NCT03008395|"     Outcomes in type 2 diabetes are largely achieved by self-management efforts by individuals     living with diabetes. Diabetes self-management is typically provided using the principles of     adult education. Current evidence suggests that standard educational interventions are     suboptimal. This study evaluates a novel approach to diabetes self-management using dialogue     tools based on empowerment and motivational communication methods. The approach evaluated in     this study is called EMMA: empowerment, motivation and medical adherence. Participants will     be randomized to EMMA and treatment as usual, treated for a period of 4 months and evaluated     over a period of 12 months.   "
21178|NCT03008369|"     This phase II trial studies how well lenvatinib works in treating patients with     pheochromocytoma or paraganglioma that has spread to other places in the body or cannot be     removed by surgery. Lenvatinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
21179|NCT03008356|"     We hypothesize that supplementation with L-carnitine that is available both as an     FDA-approved therapy for primary carnitine deficiency, as well as widely available as an     over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires     in patient with chronic obstructive pulmonary disease (COPD).      We further hypothesize based on our review of literature that addition of health coaching     (HC) to L-carnitine will yield greater gains.   "
21180|NCT03008343|"     The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus     natural killer (NK) immunotherapy to recurrent liver cancer.   "
21181|NCT03008330|"     The aim of this study is the safety and efficacy of high-activity natural killer     immunotherapy to small metastases of tongue cancer.   "
21185|NCT03008278|"     This pilot phase I/II trial studies the side effects and best dose of olaparib when given     together with ramucirumab and how well they work in treating patients with gastric or     gastroesophageal junction cancer that has spread to other places in the body, has come back,     or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Monoclonal antibodies, such as ramucirumab, may     interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab     may work better in treating patients with gastric or gastroesophageal junction cancer.   "
21187|NCT03008252|"     In the last few years a new clinical entity has emerged which includes patients who consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named     non-celiac gluten sensitivity (NCGS), although in a recent article, the researchers suggested     the term non-celiac wheat sensitivity (NCWS), because it is not known to date what     component of wheat actually causes the symptoms. The clinical picture of NCWS is     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and     extra-intestinal or systemic manifestations (headache, depression, anxiety, 'foggy mind,'     tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,     and anemia). Lactose intolerance and cow's milk protein allergy (CMPA) are two medical     conditions with a very high prevalence in the general population, and there is a large     overlap between NCWS symptoms and lactose intolerance and CMPA symptoms. Therefore, the aims     of the present study are to investigate 1) the prevalence of positive lactose breath test and     DBPC cow's milk protein challenge in NCWS patients with self-reported gastrointestinal     symptoms related to milk and/or milk derivates ingestion, 2) the clinical, serological, and     histological characteristics of NCWS patients with lactose intolerance and CMPA in comparison     to NCWS patients without lactose intolerance and CMPA.   "
21188|NCT03008239|"     This study evaluates the performance and safety of the fluorescence based fibre optic glucose     sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic     subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who     require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic     subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or     abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other     side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one     FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator     sensor will be placed in CAPD subjects.   "
21189|NCT03008226|"     The purpose of this observational study is to investigate the efficacy of 9 mm intrabronchial     valve treatment in patients with heterogeneous emphysema and to gain further insights and     experience on the treatment with this valve size.   "
21190|NCT03008213|"     Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important     in treatment of cancer patients. CINV is one of the most distressing severe side effects of     cancer treatment and can have a significant impact on a patient's quality of life. The     chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into     two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy     (HEC). Nausea and vomiting that occurs within the first day of the administration of     chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of     the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs     when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing     vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in     earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the     treatment of refractory CINV   "
21191|NCT03008200|"     Fetal PATET ratio evaluation to predict neonatal RDS   "
21192|NCT03008187|"     Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of     SEL24 in patients with AML.      At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2.      In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients     who are unfit to receive intensive chemotherapy.   "
21193|NCT03008174|"     Patients with tracheostomy who are on and off of mechanical ventilation initially lose the     ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring     speech in these patients. Patients with tracheostomy who experience loss of speech report     frustration and feelings of confinement from their communication impairment, therefore     investigators would like to restore speech in these patients as soon as it is safe to do so.     However, there is currently little known in the literature about the timing of the use of     OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test     clinical trial pilot study to investigate the safety of early use of OWSV in patients     undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit     from the early use of OWSV and to determine the effects of early use of OWSV on speech and     clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will     be screened, and patients meeting screening criteria will be randomized into intervention and     control groups. The intervention group will receive early speech-language pathology (SLP)     evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control     group will receive standard SLP evaluation and OWSV trial at 48-60 hours following     tracheostomy procedure. Intervention and control groups will been compared on speech and     clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test     at 48-60 hours following tracheostomy and characteristics of patients who successfully     tolerate early OWSV use will be identified.   "
21194|NCT03008161|"     The purpose of the study is to evaluate the safety and tolerability of multiple doses of     NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also     evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics     of multiple doses of NPT088.   "
21195|NCT03008148|"     This is a multi-center, phase II/III, open-label, randomized, parallel and standard     chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to     receive control treatment or study treatment. The primary objective of this trial is to     evaluate the effect of add-on JP001 to standard chemoradiation in increasing overall survival     (OS) on newly diagnosed glioblastoma (GBM) patients.   "
21196|NCT03008135|"     This study evaluates the reliability of the French version of the elderly mobility scale     and its correlation with the frailty elderly scale    "
21424|NCT03004157|"     Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring     effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs     in the United States annually. Only 8% of the patients survive to hospital discharge and of     these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are     below age of two and have poorer chance of survival versus older children   "
21197|NCT03008122|"     This study is randomized, double-blinded, placebo-controlled, Phase 1, dose de-escalation     study to evaluate the safety, reactogenicity, and immunogenicity of Alum Adjuvanted Zika     Virus Purified Inactivated Vaccine (ZPIV) administered to healthy male and non-pregnant     female adult subjects. This study will enroll 90 healthy male and non-pregnant female     subjects between the ages of 21 and 49 and will be conducted at Ponce Medical School     Foundation, Inc.-CAIMED in Ponce, Puerto Rico. The duration of each subject's participation     is approximately 26 months from recruitment through the last study visit. The entire study is     expected to take approximately 42 months to complete. Two dose levels will be evaluated. Each     subject will receive either placebo or 5 mcg (Group 1) or 2.5 mcg (Group 2) of ZPIV     administered by intramuscular (IM) injection on Days 1 and 29. Solicited local and systemic     reactogenicity data will be collected from all subjects through Day 8 after each vaccination.     All subjects will be monitored for occurrence of unsolicited adverse events until 28 days     after the second vaccination. The study will consist of a screening period of up to 28 days,     a vaccination period in which subjects will receive a prime dose of vaccine on Day 1 followed     by a boost on Day 29, and a follow-up period of 24 months post boost vaccination. Primary     objectives are: 1) Assess the safety and reactogenicity of a homologous prime boost regimen     of ZPIV given at two different dose levels. 2) Compare the safety and reactogenicity of ZPIV     after each vaccination, between dosage groups, and by pre-vaccination flavivirus immune     status.   "
21198|NCT03008109|"     EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR     mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS     （progression-free survival） , the OS （ overall survival） is limited extended. This study is     aim to observe the safety and efficacy of the combination of an anti-angiogenic drug     recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further     extend the PFS and OS with a tolerated toxicity.   "
21199|NCT03008096|"     In LVAD (Left-Ventricular Assist Device) patients, evidence is lacking regarding the safety     and efficacy of Laparoscopic Sleeve Gastrectomy (LSG) as a means to reach a Body Mass Index     (BMI) within listing criteria for heart transplantation. To our knowledge, this is the first     prospective study to evaluate laparoscopic sleeve gastrectomy in LVAD patients as     bridge-to-candidacy for heart transplantation.   "
21200|NCT03008083|"     This study is a prospective,multi-center, open-label, randomized controlled clinical     trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months     (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary     intervention implanted sirolimus target- eluting stent with abluminal grooves containing a     biodegradable polymer (Firehawk™ stent). All participants met the inclusion criteria begin     taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1     randomized to 3 months or 12 month of DAPT at index procedure.   "
21201|NCT03008070|"     Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may     progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes     mellitus, or insulin resistance and is very common. However, Treatment of NASH is a     significant unmet clinical need.      IVA337 is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist     addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic.      The purpose of this research is to evaluate the efficacy and the safety of two doses of     IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver     steatosis and moderate to severe necroinflammation without cirrhosis.   "
21202|NCT03008057|"     The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the     gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood mononuclear     cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of diabetes type 2     patients.   "
21203|NCT03008044|"     This is a single center prospective study. The purpose of this study is to assess the     performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to     hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in     healthy volunteers.   "
21204|NCT03008031|"     The optimal dose of iodine based contrast agents used in contrast-enhanced spectral     mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast     agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients     can receive less contrast agent for CESM in future and thereby risking less side effects of     the contrast agent.      In order to study whether CESM remains unchanged at smaller amounts of contrast     administration, a second CESM exam will be performed within one week of the first with a an     alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast     dose. The settings of the CESM unit will remain unchanged.   "
21205|NCT03008018|"     The aim of the study is to evaluate the safety/tolerability, pharmacokinetic, and     pharmaco-dynamic effects of KA2507 and establish the maximum tolerated dose (MTD). Patients     with PD-L1 expressing solid tumors which have relapsed or are refractory to prior treatment     will be eligible to participate in this study.      Following completion of the multiple ascending dose study, the protocol may be amended to     include expansion cohorts in patients with melanoma and/or other solid tumors.   "
21215|NCT03007888|"     Primary Objective:      To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate     release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).      Secondary Objectives:      To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.      To compare the efficacy of IPX203 with IR CD-LD following multiple doses.      To evaluate the safety of IPX203.   "
21216|NCT03007875|"     The aim of this study is the safety and efficacy of high-activity natural killer     immunotherapy to small metastases of non-small cell lung cancer.   "
21241|NCT03007550|"     This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy     (LTG) and open total gastrectomy (OTG) in patients with clinical stage I     (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the     early operative morbidity and mortality and determine the safety of LTG compared with OTG for     clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery     course and compare the postoperative hospital stay of the patients enrolled in this study.   "
21206|NCT03008005|"     The goal of this study is to look at how a type of drug called cannabinoids are related to     the processing of fear signals, the experience of emotions and fear, and the pattern of     activity in the brain that is involved in these processes and how this relates to the     development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs     after experiencing a traumatic event(s) and is characterized by unwanted memories of the     trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of     the event, difficulty experiencing emotions, loss of interest in activities the person used     to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger     and hypervigilance. The information gained from this study could lead to the development of     new treatments for persons who suffer from anxiety or fear-based disorders.   "
21207|NCT03007992|"     The purpose of the trial is to investigate the efficacy of metronomic treatment with daily     oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in     patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy.   "
21208|NCT03007979|"     The investigators propose to conduct a study to test an alternative dosing schedule of     palbociclib. With the current three-week on and one week off schedule, a significant number     of patients develop grade 3 or higher degree of neutropenia and require dose reduction and     sometimes discontinuation. This potentially compromises the efficacy of the drug. In     addition, as the half-life of palbociclib is 27 hours, 1 week break with the standard 3 weeks     on and 1 week off dosing schedule could potentially lead to recovery of Rb phosphorylation     during the off week. Hence, the investigators propose a 5 days on and 2 days off schedule     each week without any weeks off drug. Although the cumulative doses each 28-day cycle is     roughly the same with this schedule compared to conventional dosing, the bone marrow is not     exposed to the drug continuously for 21 days and rather gets frequent breaks from therapy.     The investigators hypothesize that the 5 days on and 2 days off schedule is more tolerable     with less frequent high grade neutropenia and dose interruption/reduction. In addition, this     schedule also provides for a more continuous drug delivery to the patient since there is not     a week's break in therapy, which could ultimately prove to be more efficacious.   "
21209|NCT03007966|"     Open inguinal herniorrhaphy is a common outpatient surgical procedure. Post-operative pain     can be a significant hindrance to discharge from the post anesthesia care unit. Pain can be     treated with opioid therapy, but the literature supports that these agents are known to     create or exacerbate adverse effects and complications, including post-operative nausea and     vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional     anesthesia results in a decreased risk of the aforementioned complications.1 Because of this,     various regional anesthetic techniques have been developed to provide analgesia following     open herniorrhaphy. One technique is a combined ilioinguinal and iliohypogastric nerve block     (IINB), which has been shown to decrease the initial pain after inguinal herniorrhaphy.2 The     quadratus lumborum block (QLB) is a newer regional anesthetic technique that we think could     be as effective as IINB at providing pain control following open herniorrhaphy. Additionally,     because local anesthetic injected during a QLB has the potential to spread cranially into the     thoracic paravertebral space following its lumbar deposition it could lead to alleviation of     both somatic and visceral pain.3 This might therefore improve the quality and or duration of     analgesia as compared to the IINB. To the best of the author's knowledge there has been no     investigation comparing the efficacy, with regards to post-operative pain management, between     IINB and QLB.   "
21210|NCT03007953|"     The focus of the study is to test a nurse-led telephone-based palliative care intervention on     improving the delivery of care for patients with newly diagnosed lung cancer. The study is a     two site randomized control trial to determine the efficacy of the intervention on improving     patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study     will test an innovative care delivery model to improve patients' access to palliative care.     The investigators will also determine the effect of the intervention on patient activation to     discuss treatment preferences with their clinician and on clinician knowledge of patients'     goals of care.   "
21211|NCT03007940|"     This is an implementation research study designed to evaluate a defined strategy, NIATx, for     its effectiveness in installing and sustaining evidence-based integrated services for persons     with co-occurring substance use and mental health disorders. This study is a cluster     randomized wait-list control group design, in which a cohort of 25 addiction treatment     agencies receives the active NIATx approach during an index 12 month period. The second     (wait-list) cohort of 25 addiction treatment agencies activates NIATx strategies during a     second index 12 month period. The primary subjects of the research are the treatment     agencies themselves. The study specific aims are:        1. Relative to wait-list, to determine if NIATx strategies improve implementation outcomes          (integrated service fidelity and receipt of more integrated services)        2. Relative to wait-list, to determine if NIATx strategies improve patient care outcomes          (psychiatric, alcohol and drug problem severity)        3. Across entire sample, to evaluate variation in the extent of and fidelity to NIATx          strategies      NIATx implementation strategies consist of learning sessions, individualized coaching and     peer to peer sharing.   "
21212|NCT03007927|"     To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual     treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia     Repair Mesh   "
21213|NCT03007914|"     The aim of this study is to compare the effectiveness of the treatments in two cohort for     COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and     have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global     Initiative for Chronic Obstructive Lung Disease (GOLD).   "
21214|NCT03007901|"     To work with community partners to pilot test a mindfulness-based behavioral program aimed     at: (a) enhancement of health and well-being, and (b) reduction in carbon footprint; (2) to     develop, implement, and refine methods for assessing carbon footprint at the individual     level; and (3) to work with pilot participants and community partners to carry out a     proof-of-concept research study to assess impact on health, well-being, and carbon footprint.   "
21227|NCT03007732|"     This is a non-comparative open-label multicenter Phase 2 clinical trial combining definitive     prostatic radiotherapy (RT) and pembrolizumab with or without intratumoral SD-101 in patients     with newly diagnosed hormone-naive oligometastatic prostate cancer.   "
21217|NCT03007862|"     Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac     arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post     cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without     use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy     of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in     patients successfully resuscitated after out-of-hospital cardiac arrest.      In this prospective non interventional study we included patients resuscitated after cardiac     arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar     lavage using specific display (Combi-Cath) was executed immediately after admission for each     patient with both biochemic and bacteriological analysis including dosage of bronchial     salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and     plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and     biological criteria. On this basis we intended to determine a threshold measure of alpha     amylase predicting occurrence of aspiration pneumonia and allowing a guidance in     antibiotherapy prescription. Sensibility and Specificity of this technique were determined.   "
21218|NCT03007849|"     Patients with sickle cell disease often develop painful crisis without any obvious reasons.     Some patients are more likely to develop this complication than others. It is now clear that     painful crisis only occurs when sickled red blood cells stick to white blood cells that have     been activated, usually by inflammation or infections. A recent study in mice with sickle     cell disease showed that the use of long term antibiotics could reduce the number of     activated white blood cells and reduce death of the mice during sickle cell crisis.      The investigators believe that sickle cell patients who develop frequent painful crisis may     have a different pattern of bacteria in their intestine when compared to those whose painful     crisis occurs infrequently. In this study, the investigators propose to study sickle cell     subject's blood to determine how many activated white blood cells he/she have. The     investigators will also examine his/her stool to compare the bacteria in his/her stool to     those other sickle cell patients. The investigators will then investigate whether or not the     results from the blood and stool tests correlate with how frequently the patient develops     painful crisis.      The investigators will examine the patients' medical records to find out how many times they     have been admitted to the hospital for sickle cell crisis in the last 12 months. The     investigators will also obtain information on the following: their age, their sex, whether     they are taking hydroxyurea or Penicillin, when they last had a transfusion or exchange     transfusion therapy and painful crisis needing hospital admission, whether they have received     any antibiotics (other than Penicillin) in the last 4 weeks, and whether they are     experiencing a painful crisis at the time that they enter the study. The investigators will     obtain, from their previous laboratory results, their levels of hemoglobin F and markers of     inflammation. The investigators will check their hemoglobin F level if they have not already     had this tested.      The investigators expect to enroll 50 subjects into this study at Rhode Island     Hospital/Hasbro Children's Hospital.   "
21219|NCT03007836|"     The aim of this study is the safety and efficacy of high-activity natural killer     immunotherapy to small metastases of nasopharyngeal cancer.   "
21220|NCT03007823|"     The aim of this study is the safety and efficacy of high-activity natural killer     immunotherapy to small metastases of melanoma.   "
21221|NCT03007810|"     Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the     treatment of psoriasis. This study is the first administration of Hemay005 in humans to     establish the initial safety, tolerability, and pharmacokinetic profile following single     doses of Hemay005. A total of approximately 44 subjects will be randomized into 6     cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be     enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1     placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study     includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit     occurring approximately 11days (±3 days) after study drug administration.   "
21222|NCT03007797|"     Introduction:      In 2010, the vaccination recommendations for pregnant women against seasonal influenza were     published by the German Standing Committee on Vaccination (STIKO). This work deals with the     immunization coverage and the influencing factors.      Method:      A cross-sectional study was realized at two Level 1 perinatal centers in two German federal     states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed     by using a standardized and pre-tested questionnaire covering their knowledge about the     influenza vaccination and other factors influencing the vaccination decision. Furthermore,     data from the vaccination card and the pregnancy record booklet have been evaluated.   "
21223|NCT03007784|"     Limited treatments are available to improve consciousness in severely brain injured patients.     Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed     evidence of efficacy to increase level of consciousness and functional communication in some     minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However     the optimal intensity of electrical current stimulation remains unknown.      This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA)     applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma     Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting     state (using algorithms previously designed and published by the investigators) and     event-related potentials (using auditory paradigms we previously published) in severely brain     damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively     disabled patients) of various etiologies.   "
21224|NCT03007771|"     This study will help to elucidate the treatment sites in the extremities and pelvis for which     MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients     with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The     investigators anticipate that successful completion of this study will lead to clinical     trials in those feasible sites of interest to determine the safety and efficacy of     administering therapeutic levels of heat for hyperthermia or other applications.   "
21225|NCT03007758|"     The purpose of this study is to determine how the robotic retromuscular hernia repair     compares to the open retromuscular hernia repair for large hernia defects in patients at     higher risk of wound complications.   "
21226|NCT03007745|"     Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and     recognized as a major public health concern, most Veterans with this disorder are undiagnosed     and therefore untreated. Access to sleep laboratories for testing is limited particularly for     those Veterans living in rural areas and Veterans with disabilities that prevent travel to a     sleep center. The goal of this study is to compare a web-based telehealth management strategy     to in-person management. The telehealth pathway will enable Veterans to be diagnosed and     treated without visiting a sleep center. The investigators believe that telehealth management     will increase Veterans' access to this specialized care at a cost that is less than in-person     delivery but with similar improvements in daytime function.   "
21228|NCT03007719|"     This is a single-center cross-sectional imaging study in patients with localized bladder     cancer undergoing neoadjuvant atezolizumab as part of a companion clinical trial     (NCT02451423; Phase 2 study of atezolizumab in non-metastatic bladder transitional cell     carcinoma), and patients with locally advanced or metastatic bladder cancer receiving     standard of care (SOC) atezolizumab. For the neoadjuvant cohort, study participants will     undergo whole body PET(Positron Emission Tomography)/MR(Magnetic Resonance) imaging with     [18F]F-AraG within 7 days of initiating atezolizumab and within 7 days before surgery. For     the SOC cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG     within 7 days of initiating atezolizumab and between Day 14 and Day 21 of Cycle 1     atezolizumab.   "
21229|NCT03007706|"     This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics     given to women undergoing a cesarean section for reducing the incidence of postpartum     infectious morbidity and to assess potential maternal adverse effects and any impact on the     infant.   "
21230|NCT03007693|"     The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after     multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of     JNJ-61393215 in plasma after multiple consecutive dose administrations.   "
21231|NCT03007680|"     The purpose of this study is to determine whether core muscle activation is effective in the     increase of quality of cardiopulmonary resuscitation.   "
21232|NCT03007667|"     To investigate the changes in the anatomical location of ureters after colorectal surgery.   "
21233|NCT03007654|"     The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an     antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.   "
21234|NCT03007641|"     The purpose of this study is to enhance the care of older metastatic breast cancer (MBC)     patients by increasing awareness among oncology providers as to the unique aspects of care     required for older patients. The goal of the study is to educate providers on the utility of     geriatric assessment in guiding therapy of older metastatic breast cancer patients. The     investigators will also assess the feasibility and benefit of incorporating geriatric     self-assessments into clinical practice. The study will include three phases.   "
21235|NCT03007628|"     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and     its safety among schizophrenia patients. Half of the participants will be randomized to MST     group, while the other half will be randomized to receive electroconvulsive therapy (ECT).   "
21236|NCT03007615|"     To evaluate the safety of an investigational product through the verification of signs of     irritability and sensitization of the genital mucosa, as well as the instrumental     moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy     perceived by the volunteers.   "
21237|NCT03007602|"     Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with     the involvement of blood, bone marrow or other organs.There are various treatment options for     hematological malignancies ranging from follow-up to single or multiple agent chemotherapy,     radiotherapy, immunotherapy and autologous or allogeneic hematopoietic stem cell     transplantations (HSCT). The general recommendation for patients is to relax and avoid     intense exercise, regardless of the devastating consequences of neglecting physical exercise.     Patients also go to relaxation by reducing their activity to avoid fatigue, which leads to     loss of muscle strength and endurance. As a consequence of all, fatigue, vomiting, weight     loss, anemia, depression, decreased aerobic capacity, muscle weakness, decreased physical     function and poor quality of life are observed in HSCT recipients. It has been shown that     physical exercises improve oxygen consumption, depression and fatigue, cardiorespiratory     fitness, muscle strength and physical well-being in patients with hematologic malignancies     who are at stages of various treatments. In literature, effects of upper extremity aerobic     exercise training have been investigated in patients with spinal cord injury, neuromuscular     diseases, claudication, hypertension, multiple sclerosis, heart failure, paraplegic patients     and healthy individuals. Results of these studies has shown that upper extremity aerobic     exercise training improves walking distance, increases oxygen pulse, muscle strength and     endurance of upper extremity. No study was observed to investigate the effects of upper     extremity aerobic exercise training on exercise capacity and quality of life in HSCT     recipients, as we know. For this reason, our aim is to investigate the effects of upper     extremity aerobic exercise training on exercise capacity and quality of life in HSCT     recipients.   "
21238|NCT03007589|"     The purpose of this study is to assess how sunscreens and sun protection fabrics perform in     natural sunlight compared to their labeled claims, indoor testing methods (existing or     modified) and instructions.   "
21239|NCT03007576|"     Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an     important mission to develop a new treatment for OA. Recently, cellular therapy is a new and     popular medical treatment around the world, one of them is Mesenchymal Stromal Cells     (MSCs). MSCs are found in many tissues of human body and play an important role for     repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for     osteoarthritis treatment becomes a developing target for new generation drugs.      This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When     the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank     until all release tests passed. On the distribution day, cell will be thawed and injected     into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion     of seven days, one month, six months and one year. The monitoring items include the changes     of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).   "
21240|NCT03007563|"     Neonatal jaundice is a common and most often harmless condition. However, when unrecognized     it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated     to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in     most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease     is therefore to identify then children at risk. This results in the need for low-cost,     reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.      Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a     smartphone application has been developed. This prototype will be evaluated in a clinical     trial at St.Olav Hospital, Trondheim, Norway. A smartphone will be used to take picture of     the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration     is made. The results from these estimates will be compared to the bilirubin levels measured     in standard blood samples, as well as the results from ordinary transcutaneous measurement     devices.   "
21265|NCT03007225|"     This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with     chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of     hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after     embolization   "
21243|NCT03007524|"     This is a prospective, randomized trial comparing different doses of rosuvastatin in patients     with acute coronary syndrome post drug-eluting stents implantation. Through the study, the     investigators aim to evaluate the effects of high dose rosuvastatin calcium on target     vessel endothelialization and non-target vessel plaque stability. Moreover, the     investigators may provide mechanically evidence of clinical application of high dose     rosuvastatin in patients with acute coronary syndrome.   "
21244|NCT03007511|"     A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device     on 15 adult patients with a need for enteral feeding. The primary outcome will be to evaluate     safety, usability and discomfort throughout the study   "
21245|NCT03007498|"     Check the safety under normal conditions of use through the verification of emergence signs     of irritability and sensitisation of the genital mucosa.   "
21246|NCT03007485|"     Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause     of hospitalization for older adults in the U.S., and a leading cause of death. Although there     is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines exercise     and education, can help decrease re-hospitalizations and improve patients' quality of life.     Unfortunately, very few COPD Latino and African-American patients actually get PR. These     patients are unlikely to get referrals or to be able to attend PR due to lack of insurance,     lack of transportation, or lack of a PR center in their area. Telehealth is a way of using     computers to deliver healthcare long-distance, eliminating the need for a patient to travel     to receive care. By using telehealth for PR, the patient can exercise on a stationary bike in     his or her home, while being supervised by videoconference by a respiratory therapist (RT).     The RT can see the patient, and deliver education by videoconference, and the patient can     see the RT, so the patient does not need to leave home to get PR.   "
21247|NCT03007459|"     Fitness athletes emphasize the value of staying lean, muscular and defined, and motivates and     inspires followers through social media. We want to study the effect of such lifestyle on     selected aspects of psychological and physical health in female fitness athletes, and compare     the outcomes to a healthy, physically active female population.   "
21248|NCT03007446|"     This is a Prospective，Single-center，Single-arm，Open-label exploratory clinical trial     evaluating the efficacy and safety of Convension Surgery for Apatinib plus SOX for patients     with unresectable gastric cancer.   "
21249|NCT03007433|"     Dyspeptic symptoms such as abdominal pain, bloating and nausea after a meal are common;     however the cause of these problems in many patients is often unclear despite medical     investigation. This is because dyspeptic symptoms are only rarely related to acid reflux,     stomach ulcers or cancer that can be diagnosed by endoscopy. Rather, the cause is abnormal     stomach function, so-called functional dyspepsia, a condition in which the digestive system     does not function normally after a meal. Gastric scintigraphy is the standard investigation     of stomach function in patients with this condition. It involves eating a small test meal     that includes a tiny dose of radioactive material so that the movement of food can be     visualised as it empties from the stomach. An important limitation of this approach is that     symptoms are rarely caused and delayed emptying after a small meal is present only in a     minority of patients and, thus, the ability of this investigation to explain the cause of     symptoms or guide medical treatment is limited.      This research project is designed to compare three new investigations of stomach function     using a relatively large meal. This information will help to explain the causes of symptoms     after a meal. The investigations to be tested include: (1) Nutrient Drink Test, (2) Gastric     Scintigraphy and (3) Magnetic Resonance Imaging. All three tests are safe, easy to perform     and non-invasive (i.e. do not involve inserting catheters through the nose and into the     stomach or taking blood). The results should provide more useful information to doctors     looking after patients with dyspeptic symptoms.      This study will compare test results from healthy volunteers, with patients attending clinic     for investigation of dyspeptic symptoms. The aim is to document abnormal function of the     stomach and intestines and to identify the causes of dyspeptic symptoms after a meal.   "
21250|NCT03007420|"     Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury,     possibly generated by a number of stressors to the trigeminovascular and cervical plexus     networks, including inflammation of the high cervical facet joints, traumatic cranial     neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for     PTH management except for conservative modalities, such as cognitive rest, physical therapy,     and neuropathic pain medications, all of which have minimal evidence to support them.      The investigators propose a randomized, controlled, clinical trial and prospective follow-up     study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and     cervical medial branch block (CMBB) in the management of PTH.      Adolescents and young adults (14-35 years of age) will be recruited from Boston Children's     Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and     Headache clinics.   "
21251|NCT03007407|"     This study is being done to look at the safety and response to the combination of two     investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for     patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and     durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune     system to destroy the cancer cells.      In order to learn more about certain characteristics of colorectal cancer tumors, this study     includes special research tests using samples from diagnostic tumors, fresh tumor samples     from an area where the cancer has spread, and blood samples.   "
21252|NCT03007394|"     The objective of this study is to evaluate the efficacy and safety of lorcaserin in the     treatment of cocaine use disorder.   "
21266|NCT03007212|"     Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess     the outcomes after TACE in patients with branch PVT regarding Child classification,     radiological response and 1 year survival.   "
21308|NCT03006666|"     Cluster randomized trial to test the impact of peer health coaches on prediabetic patients.     This study will test a scalable model of peer health coaching to address the millions of     patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to     promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.   "
21332|NCT03006341|"     The objectives of this study are, first, to identify select clinical covariates from     electronic medical records (EMR) that might be associated with initiation of oral     anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial     fibrillation (NVAF) at risk for stroke; second, to quantify the association between EMR-based     clinical characteristics and patterns of insurance claims; third, to assess the potential for     unmeasured confounding in dabigatran vs warfarin comparative effectiveness and safety studies     based on administrative claims databases.   "
24629|NCT02963298|"     Glutamate is known to be a mediator for apoptosis after brain hypoxia e.g. due to cardiac     arrest. This pilot trial evaluates the possibility of elimination of Glutamate by CRRT after     cardiac arrest.   "
21253|NCT03007381|"     Background: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that has been     shown to reduce breakthrough narcotic consumption following orthopaedic, neurosurgical, and     obstetrical procedures. The morphine-sparing effect of ketorolac may reduce respiratory and     central nervous system depression post operatively, while still providing adequate pain     control for patients. Patients undergoing abdominally based microsurgical breast     reconstruction may particularly benefit from ketorolac postoperatively, and ultimately be     safely discharged from hospital sooner than their counterparts receiving standard of care.      Research Question: In adult women post-mastectomy, undergoing abdominally based microsurgical     breast reconstruction, does a postoperative regimen of intravenous ketorolac tromethamine, in     addition to standard of care, reduce the length of postoperative hospital stay compared with     an intravenous sham saline regimen?      Study Design: A single center, explanatory, placebo-controlled, 1:1 allocation, 2-arm,     parallel group, superiority, randomized, and double blinded, controlled trial.      Population: The study population includes all females >18 years old post mastectomy     consenting to abdominally based microsurgical breast reconstruction.      Intervention and Comparator: The intervention will be ketorolac 30 mg IV every 6 hours     postoperatively for 72 hours. The comparator will be a sham intravenous administration of     normal saline.      Outcomes: The primary outcome is hospital length of stay postoperatively. Secondary outcomes     include visual analog scale for pain, breakthrough narcotic consumption, surgical drain     outputs, hematoma, and other complications.      Sample Size: Available data provided estimates for average length of hospital stay and     standard deviation. A minimally clinically significant difference of 1 day was decided on due     to expert opinion. Based on a power of 80% and alpha of 0.05, and inflated to account for     attrition and efficiency losses, a total of 50 patients (25 per group) will be required for     this study.   "
21254|NCT03007368|"     As populations become urbanized in Africa, the change to a more Westernized diet has been     associated with rise in obesity and related metabolic syndrome diseases. The current study     shows that in the West African Sahel, these replacement starchy staple foods have fast     gastric emptying compared to traditional sorghum and millet foods; and implies that the     latter could be beneficial in lowering glycemic response, providing energy from a meal over a     longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and     millet foods could be useful to improve their image in West African cities to increase their     consumption and to improve markets for local smallholder farmers.   "
21255|NCT03007355|"     Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of     hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue     perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive     new monitoring, can reflect the peripheral perfusion dynamics.      This study is designed to explore the behavior and trend of PPI during deliberate hypotensive     anesthesia in adult patients undergoing functional endoscopic sinus surgery (FESS).   "
21256|NCT03007342|"     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect     of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult     patient with symptomatic apical periodontitis.   "
21257|NCT03007329|"     SGLT2 antagonists and GLP1 agonists are used since a relatively short period as second line     therapy if indicated and are well tolerated by patients featuring low risk of hypoglycaemia     in comparison to insulin or other oral glucose lowering drug. This new treatment options     offer an effective modality to lower blood glucose, if first line therapeutics fail.     According to national and international guidelines combination of oral glucose lowering drugs     is possible in multiple ways, but is currently not recommended for GLP1 agonists and SGLT2     inhibitors yet, as evidence and supporting studies are missing proving efficacy and safety].     Thus studies under standardized conditions are urgently needed to answer these unsolved     questions.      First results of a combination of a SGLT2 Inhibitor and a GLP1 agonist demonstrated huge     potential regarding glucose and weight reduction and safety issues. However, further studies     are necessary to elucidate potential mechanisms of combination therapy with SGLT2 inhibitors     and GLP1 agonists and its effect on weight loss, glucose control, effects on incretins and     adipokines, as well as further effects on ectopic lipid accumulation in liver and other     tissues as myocard or pancreas in humans.      As both monotherapies have effects on weight and metabolism, changes in abdominal,     subcutaneous, hepatic, myocardial or pancreatic lipid content might be speculated and are     focus of interest in this study. Recently GLP1 agonists were shown to have effects on hepatic     lipid reduction in humans with diabetes.      Hepatic lipid content and steatosis hepatis are widely discussed to have major effects on     progression of diabetes and cardiovascular disease. Thus reduction of lipid accumulation in     hepatic tissue might have an effect on diabetes progression.      Also higher myocardial lipid accumulation is seen in diabetic patients probably partly     responsible for higher cardiovascular risk in diabetics. So far results combining these two     drug classes show less weight loss as might have been expected using monotherapy, so that     further investigation will definitely shed light on combination of therapeutic concepts.      Facing a multiple of positive side effects (weight loss, blood pressure lowering, potential     protective cardiac effects) using a combination of SGLT2 and GLP1 seems to be a promising     therapeutic option in diabetic subjects.   "
21258|NCT03007316|"     An array of soft tissue augmentation techniques have been employed concomitant to implant     placement, as free connective tissue grafts or pedicle grafts for keratinized tissue     thickening in attempt not only to augment the soft tissue for better resistance to     inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.      Results obtained from the literature were controversial regarding the need of soft tissue     augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature     was found, that monitored the ridge alterations following implant placement.      Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and     buccal bone resorption during the process of remodeling in a measurable way.   "
21259|NCT03007303|"     This study investigates the relationship of circulating microRNA-30e and schizophrenia, and     shows the relevance of the aberrant microRNA-30e expression in plasma with the variation     disease status.   "
21260|NCT03007290|"     Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with     colistin   "
21261|NCT03007277|"     The PANJO study aims to evaluate, within the French public health services, the impact of a     home visitors training on parent-child attachment, families outcomes, use of services and     child maltreatment indicators.   "
21262|NCT03007264|"     In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin     of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial     effect will be investigated as well. The investigators expect this treatment to have a good     antimicrobial effect with acceptable, transient skin sensations.   "
21263|NCT03007251|"     The purpose of this study is to investigate different effects of Eurythmy Therapy on     psychological and physiological parameters of circulation and thermoregulation   "
21264|NCT03007238|"     This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin     (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does     not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a     small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to     control the immune system. Extracorporeal photopheresis is a procedure where patient's blood     is removed and treated with ultraviolet light and drugs that become active when exposed to     light. The treated blood is then returned to the patient and may be effective in increasing     T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white     blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be     effective improving GVHD symptoms.   "
21267|NCT03007199|"     The AGNES case-control set consists of individuals with a first acute ST-elevation myocardial     infarction. AGNES cases have ECG- registered ventricular fibrillation occurring before     reperfusion therapy for an acute and first ST-elevation myocardial infarction. AGNES controls     are individuals with a first acute ST-elevation myocardial infarction but without ventricular     fibrillation. All cases and controls are recruited at seven heart centers in The Netherlands.     The investigators' exclude individuals with an actual non-ST-elevation myocardial infarction,     prior myocardial infarction, congenital heart defects, known structural heart disease, severe     comorbidity, electrolyte disturbances, trauma at presentation, recent surgery, previous     coronary artery bypass graft or use of class I and III antiarrhythmic drugs. Individuals who     develop ventricular fibrillation during or after percutaneous coronary intervention are not     eligible. Furthermore, because early reperfusion limits the opportunity of developing     ventricular fibrillation, potential control subjects undergoing percutaneous coronary     intervention within 2 h after onset of myocardial ischemia symptoms were not included. This     time interval is based on the observation that >90% of cases develop ventricular fibrillation     within 2 h after onset of the complaint of symptoms.   "
21268|NCT03007186|"     This study aims to show whether the hyperglycaemic phases following a treatment with     glucocorticoids, as well as blood measurements correlated to high blood glucose levels and     insulin resistance, vary significantly between patients with and without gestational diabetes     mellitus.   "
21269|NCT03007173|"     Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep     navels and poor personal hygiene; however, it can be seen in females. UPS could easily be     misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. Diagnosis     is easy to establish with physical examination and a detailed history. Treatment is generally     depending on the severity of the disease, ranging from good personal hygiene to surgical     excision of umbilical complex. The treatment of choice for chronic, intermittent cases is     surgical removal of the affected portion; paying special attention to cosmetic appearance     especially in female patients. In this report, we present two cases of UPS, one in a man and     one in a woman with the explanation of its etiopathogenesis and surgical treatment.   "
21270|NCT03007160|"     Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis     formation or recurrence.   "
21272|NCT03007134|"     The purpose of this study is to (1) compare a technically improved assay with an existing     assay used to measure serum anti-GM-CSF antibodies in stored serum samples previously     obtained from patients diagnosed with either primary, secondary, congenital or idiopathic     pulmonary alveolar proteinosis (PAP), other chronic diseases or disease-free, healthy     individuals; (2) determine the prevalence and levels of anti-GM-CSF autoantibodies and (3)     define the breadth of the autoimmune antibody responses in primary PAP patients from the     United States, Japan, Australia, and Europe using previously collected serum samples; and (4)     using a chart review approach, compare the clinical, radiologic and laboratory features of     primary PAP patients to determine if differences exist among patients in these globally     geographically distributed regions.   "
21273|NCT03007121|"     The purpose of this study is to determine which postoperative analgesia is optimal after     colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural     analgesia and standard systemic analgesia. All patients will have the possibility to     administer themselves intravenous morphine as needed.   "
21274|NCT03007108|"     The aim of this study is to establish normal values of thrombin generation assay parameters     in pediatrics, according to different age groups. The standardized thrombin generation assay     Genesia™ will be used. Different age groups of healthy children will be recruited :     neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15     years old. Adults values will be obtained (healthy adults > 18 years old).   "
21275|NCT03007095|"     The study aims at investigating social cognition outcomes of children born prematurely.     Social cognition can be briefly defined as a process which underlines people's social and     emotional behaviors. There are behavioral and cognitive evidences indicating that preterm     children have executive dysfunctions. Executive functions refer to multiple cognitive     processes that contribute to human higher order abilities, such as purposeful and     future-orientated behavior. The literature regarding development of term born children     indicates that executive functions are linked to the emergence of social cognition. Then, the     investigators asked if children born prematurely, as they commonly present executive     dysfunctions, would show an atypical development of social cognition. Additionally, as it has     been shown that parental anxiety is a key factor of preterm children development, the     investigators assumed that it should play a role in social cognition outcomes.   "
21276|NCT03007082|"     This is a multicenter, prospective registry clinical study to evaluate the real-world     efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE     device on the basis of standardised medical treatment.   "
21277|NCT03007069|"     Using growth factors obtained from patient's venous blood mixed with particulate autogenous     bone the study compares bone gain by implant with gold standards.   "
21278|NCT03007056|"     The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy,     oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also     evaluated.   "
21279|NCT03007043|"     To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as     well as other, less studied, gonadotropin polymorphisms between ovarian response groups,     following ovarian stimulation   "
21280|NCT03007030|"     The goal of this clinical research study is to learn if Adcetris (brentuximab vedotin) can     help to control mesothelioma. The safety of this drug will also be studied.   "
21333|NCT03006328|"     The GEM intervention leverages the patient-centered medical home model by using the GEM tool     to provide individually tailored, patient-centered care at the time of the primary care     visit, promote standardized weight management counseling by health coaches and primary team     members, coordinate care between teams and other weight management service providers/programs     (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary     care team about patients' weight management-related goals, progress, and care.   "
24630|NCT02963285|"     The purpose of this study is to determine the optimal range of insertion depths for a     nasopharyngeal probe in anesthetized pediatric patients as a function of age.   "
21281|NCT03007017|"     Despite many efforts to increase the size of the donor pool, there is a large and growing     disparity between the number of donor kidneys available for transplantation and the number of     patients on the transplant waiting list. Increasing the quality of currently available donor     kidneys would potentially improve the longevity of deceased donor kidney transplants by     years, thus increasing the rate of transplantation patients on the kidney transplant waiting     list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower     total hospital charges. By innovating the organ donation process, such that deceased donor     kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be     possible to improve the quality of the kidney before transplantation, resulting in improved     function after transplantation and increased longevity of these transplanted kidneys.     Further, this improved kidney quality is highly likely to translate to reduced need for renal     dialysis and other high-cost interventions, yielding lower total hospital charges. In this     study we will test the hypothesis that, through a cost-free technical innovation, the quality     of deceased donor kidneys could be improved significantly, saving thousands more lives per     year and reducing total health care expenditures on renal transplantation.   "
21282|NCT03007004|"     Efficacy and safety of local infusion of botulinum toxin type B in patients with systemic     sclerosis (SSc) with digital ulcer is evaluated by a randomized, double-blind study.   "
21283|NCT03006991|"     This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective     concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics     model to provide reference for individual administration on JIA pediatric patients.   "
21284|NCT03006978|"     The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of     the TearCare™ System compared to standardized warm compress therapy for the application of     controlled, localized heat therapy in adult patients with dry eye syndrome.   "
21285|NCT03006965|"     The purpose of this study is to describe the pharmacokinetic profile of patients with     hemophilia A in prophylaxis in Spain using myPKFit®   "
21286|NCT03006952|"     This study was designed to assess the efficacy of adding pentoxifylline to losartan in     comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy.     also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and     C-reactive protein   "
21287|NCT03006939|"     Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes     survival in late-stage ovarian cancer patients. Little is known about the intraoperative     fluid balance and its impact on morbidity and mortality.   "
21288|NCT03006926|"     This is an open-label Phase 1b study designed to evaluate the tolerability and safety of     lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma     (HCC).   "
21289|NCT03006913|"     Using mixed methods, investigators will conduct a multicenter partially randomized preference     noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients     assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a)     in-person; (b) phone; or (c) video conference. A total of 600 patients will complete     counseling and 540 will complete the final survey. Baseline and post-counseling surveys will     use validated measures (adapted for literacy and language) of study outcomes. All counseling     sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content     and to identify 30 participants for in-depth interviews and analysis triangulating all forms     of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the     strengths and limitations of each counseling mode.   "
21290|NCT03006900|"     Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to     the more traditional exercise programs. Although somewhat limited, previous research has     suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded,     randomized controlled study has one intervention group (Pilates and massage therapy) and one     control group (massage therapy only). The primary outcome of interest is the change in     walking ability between groups. Secondary outcomes include other measures of physical     performance and quality of life.   "
21291|NCT03006887|"     This is an open-label Phase 1b study designed to confirm the tolerability and safety of     lenvatinib in combination with pembrolizumab in participants with selected solid tumors     (non-small cell lung cancer, predominantly clear cell renal cell carcinoma, endometrial     carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma     [excluding uveal melanoma]).   "
21292|NCT03006874|"     The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared     to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)     classification grades A to D at Week 8.   "
21293|NCT03006861|"     Creatine is a nutritional supplement that is often ingested to improve exercise performance.     The advent of a new product that is applied to the skin overlying muscle offers potential     benefit, if the creatine can be targeted to specific muscles. The investigators are testing a     novel creatine cream to determine the effects on human muscular performance. The     investigators are assessing whether 7 days of topical creatine application is additive to     orally-ingested creatine for improving muscular power (determined by knee extension).   "
21305|NCT03006705|"     The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant     chemotherapy with ONO-4538 in combination with tegafur-gimeracil-oteracil potassium (S-1     therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in     combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including     esophagogastric junction cancer) after D2 or more extensive lymph node dissection.   "
21306|NCT03006692|"     In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas     testing is present since 2014. This study will determine if a prehospital arterial blood gas     helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be     determined if the doctors find this device helpful in assessing and treating patients with     affected consciousness.   "
21307|NCT03006679|"     The purpose of this study is to determine the efficacy, safety, tolerability, and     pharmacokinetics (PK) of meropenem-vaborbactam compared to piperacillin/tazobactam for 7 to     14 days in the treatment of hospitalized adults who meet clinical, radiographic, and     microbiological criteria for hospital-acquired bacterial pneumonia (HABP) or     ventilator-associated bacterial pneumonia (VABP).   "
21294|NCT03006848|"     This clinical trial seeks to determine if avelumab will be effective in facilitating removal     of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab     will be evaluated using dosing that has previously been determined in adult studies.      Primary Objectives:        -  To estimate the response rate to 4 cycles of avelumab in patients with recurrent or          progressive osteosarcoma.        -  To estimate the 16-week progression free survival of patients with recurrent or          progressive osteosarcoma after treatment with avelumab.      Secondary Objective:        -  To describe the toxicities associated with the administration of avelumab in patients          with recurrent or progressive osteosarcoma.        -  To assess the quality of life of patients with recurrent or progressive osteosarcoma          undergoing treatment with avelumab, and to explore relationships between clinical          factors and patient-reported health-related quality of life (HRQOL) outcomes.      Exploratory Objectives:        -  To explore factors associated with response in patients treated with avelumab after          recurrent or progressive osteosarcoma (e.g. tumor PD-L1 expression).        -  To measure parameters of immune activation including subsets of peripheral blood          mononuclear cells (PBMCs) and serum markers of immune activation.        -  To evaluate the role of T-cells in immune checkpoint blockade via measures of cell          proliferation, co-inhibitory receptor expression on CD8 T cells, T cell repertoire, and          epigenetic programming.   "
21295|NCT03006835|"     This is a single-center, randomized, single-blind, investigator-initiated, pharmacological     study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary     intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following     treatment groups:      Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.      Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.      Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.      Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.      Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the     loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram.     Documentation of major adverse cardiac events (death, myocardial infarction, stroke,     revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other     adverse events)will be performed until Day 30.   "
21296|NCT03006822|"     Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high     prevalent and may influence the neck and shoulder conditions. The pressure release is one of     the most recommended manual therapy techniques.      Objective: To determine the time effect of the pressure release technique application in the     latent MTrPs of the levator scapulae muscle.      Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.      The manual technique than us apply, be sustained digital pressure with thumbs or with the     2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling     of tissue resistance (barrier), as decreases, adds more pressure. different times of     sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a     control), 60 (group 2) and 90 seconds (group 3) shall apply.   "
21297|NCT03006809|"     This is a prospective unblinded, randomized trial for the use of Fecal Microbiota     Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or     without antibiotic pretreatment.   "
21298|NCT03006796|"     This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared     with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial     hypertension and obesity.   "
21299|NCT03006783|"     A retrospective and cross-sectional analysis of standard of care for facial paralysis     involving the cross-face nerve graft in the past 20 years.        -  Imagery analysis        -  Questionnaires   "
21300|NCT03006770|"     This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III     study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular     Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with     Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.   "
21301|NCT03006757|"     The purpose of this study is to compare the effect of rapid heat cured acrylic resin material     with titanium dioxide nanoparticles added to conventional acrylic resin material on the     biting force of the single maxillary complete denture .   "
21302|NCT03006744|"     The promotion of language and communicative development in the early years is extremely     important. Children who enter school with good language skills have better educational and     economic success. This study is part of a large project across Liverpool, Manchester and     Sheffield Universities to determine how shared reading promotes child language development,     and use this knowledge to make it an effective language boosting tool for children across the     whole socio-economic spectrum. The overall project includes:        -  observational studies to identify what language boosting behaviours are responsible for          shared reading's effectiveness, and how parents from different socio-economic groups use          these behaviours during shared reading;        -  intervention studies to evaluate packages designed to train parents in the use of          specific language boosting behaviours during reading;        -  a qualitative exploration of the reasons people may not read with their children.      This study will provide training to parents on how to develop their children's attention to     the features of words while reading books with them. The research questions are:      i) Is specific training focused on the sound properties of words during shared reading more     effective at developing children's phonological awareness and language than general advice on     the importance of reading with children? ii) Do children with speech sound disorder and     typically developing children respond differently to intervention? iii) To what extent are     differences in training implementation and effects explained by socio-economic status?      Our participants will be parents and their children, aged 30-54 months, with a diagnosis of     speech sound disorder. They will be recruited via speech and language therapy services in the     North West. Data collection will be carried out by the research team in participants' homes,     taking 3-4 hours in total over 2-3 appointments. The sessions will be audio-recorded; parents     will complete questionnaires, and children's language and speech will be assessed with     standardised and in-house tests.   "
21303|NCT03006731|"     The purpose of this study is to compare the effects of an exercise training strategy called     high-intensity interval training (HIIT) to moderate intensity continuous exercise (MICE), on     walking function and cardiovascular fitness in stroke patients. Hypothesis: HIIT will result     in significantly greater benefit to fitness and mobility than MICE.   "
21304|NCT03006718|"     The overall goal of the project is to reduce pain-related, 30-day readmission rates for     sickle cell disease (SCD) patients. The investigators want to see if a mobile phone     application (app) can help decrease the need for repeat admission to the hospital because of     sickle cell pain.   "
21773|NCT03000595|"     This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and     efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment     regimen when administered daily for up to 28 days to patients from 3 months to 65 years of     age, with atopic dermatitis.   "
21309|NCT03006653|"     Understanding Daily Fluctuations in Self-Regulation, also known as the Digital Marshmallow     Test (DMT), is a collaboration by Northwell Health, Cornell Tech, and Sage Bionetworks.     Funded by the Robert Wood Johnson Foundation, this is a pioneering study to advance the     science in identifying and helping individuals who act on short-term temptations, despite     long-term consequences. Using Apple's ResearchKit(™) and Android's ResearchStack     applications, the Digital Marshmallow Test will leverage the powerful capabilities of the     smartphone to examine impulsivity using a range of game-like tasks and sensor capabilities     within the mobile phone. Across studies, more impulsive individuals are significantly more     likely to suffer from obesity, Type II Diabetes, substance abuse, gambling problems, suicidal     behaviors, and increased criminality among many other problems. Early self-report studies     reveal a relationship between the inability to delay gratification and different patterns of     mobile phone use. This will be the first study to develop non-invasive mobile methods to     identify and help those at greatest risk for impulsive responding before serious problems     occur.   "
21310|NCT03006640|"     Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients,     difficult sampling and problems encountered with noninvasive blood pressure monitoring makes     arterial cannulation an essential skill in many situations like surgeries or trans-radial     procedures for coronary or carotid interventions.      Radial artery has been preferred over other sites for arterial cannulation due to low     incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this     study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming     to decrease insertion time, increase success rate and decrease related complications   "
21311|NCT03006627|"     Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences     in the opioid analgesia have been reported and investigated in human subjects and animal     models In this study, effects of sex difference on response to opioid analgesics after     abdominal surgeries will be assessed regarding; analgesic duration (primary variable),     frequency of analgesic requirement, total opioid consumption, Opioid related complications     (respiratory depression, Nausea & vomiting, itching, over-sedation, delayed intestinal     motility).   "
21312|NCT03006614|"     This study aims to explore new PERS prediction model can improve the pathological complete     response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.   "
21313|NCT03006601|"     This study aims to determine the treatment effect of vision therapy on myopic children by     assessment of accommodative function before and after therapy.   "
21314|NCT03006588|"     EUS-FNA for RPLN in NPC   "
21315|NCT03006575|"     This Phase II randomized study is to determine the efficacy of consolidation chemotherapy     after split irradiation with concurrent chemotherapy in locoregional recurrence of non-small     cell lung cancer after surgical resection   "
21316|NCT03006562|"     The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis     (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of     IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy     (RP).   "
21317|NCT03006549|"     Despite increasing interest in emergency manuals (EMs), relatively little is known about     their effectiveness and limitations in the perioperative setting. Prior studies have been     limited in that they evaluated EMs using crises that were tailor-made to match one of their     chapters, and there has been minimal participation by attending surgeons and other     experienced personnel. The Investigators' preliminary experience suggests less-than-expected     EM use and suboptimal usage, which may be due to the simulation scenario falling halfway     between two different chapters of the EM, raising the question of whether limitations were     due to the EM content, team dynamics, or inadequate training in the EM use. In this     randomized, prospective, two-center simulation-based study, the investigators utilize     clinical scenarios specifically designed to observe the patterns of use and to test the     limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen,     clinical performance in situations that do not exactly match a specific chapter of that EM,     and that EM usage patterns will identify both strengths and limitations of the tools and its     implementation. The participating healthcare providers consisting of experienced surgeons,     anesthesiologists, and nurses will be randomized into four experimental groups, each exposed     to either a specific or non-specific simulation scenario, along with or without the     availability of the EM. The major experimental endpoint will be how many critical actions     each team performs, scored as the percentage of actions taken from a pre-determined list. The     goal of this study is to improve EM content and use by understanding its limitations during     interprofessional team-training simulations and to study whether EMs enhance or detract from     clinical performance. This is especially a concern in situations that do not exactly match a     specific chapter of the EM, such as cases that are vague and represent multi-factorial     diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen     patient safety by providing guidance for improving EM content, use, and training protocols.   "
21318|NCT03006536|"     The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function     and triggers angiogenesis through induction of local growth factors and endothelial nitric     oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies     investigating the clinical effects have been encouraging. Meanwhile, randomized trials have     shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed     statistically greater improvements in the Erectile Function Domain of the International Index     of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment     (p=0.032).   "
21319|NCT03006523|"     To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It is     hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher clinical     pregnancy rates will be achieved by promoting higher sperm densities in the fallopian tubes     at the time of ovulation by decreasing the amount of sperm cells lost during preparation and     handling.   "
21328|NCT03006393|"     The main purpose of this study is to examine the effects of infliximab on measures related to     depression symptoms. Infliximab is also known by its brand name Remicade. Infliximab, or     Remicade, is given to by an intravenous (IV) needle and is currently used to treat rheumatoid     arthritis and Crohn's disease. Infliximab is thought to help these conditions because it     reduces inflammation in the body. Infliximab (Remicade) reduces inflammation by blocking a     chemical in the body called tumor necrosis factor (TNF)-alpha. This chemical produces     inflammation. Inflammatory chemicals in the body like TNF-alpha appear to be increased in     some people with major depression. Researchers believe that a drug like infliximab, which     blocks TNF-alpha, may be helpful in treating depression.      This is a double-blind, placebo-controlled study in which participants will be randomized to     receive one infusion of infliximab or placebo. The study will assess neuroimaging measures of     corticostriatal circuitry before and after a placebo-controlled pharmacologic blockade of     inflammation in 80 depressed patients.   "
21774|NCT03000582|"     The purpose of this study is to examine the pharmacokinetics of creatine nitrate     supplementation.   "
21320|NCT03006510|"     Our goal for this Learning Healthcare System Demonstration Project is to reduce the rate of     inpatient hypoglycemia. Hypoglycemia can result in longer lengths of stay and increased     morbidity and mortality (ie falls and cardiovascular or cerebral events).      The group at Washington University (WSL) developed a predictive hypoglycemia risk score.     Using current glucose, body weight, creatinine clearance, insulin type and dosing, and oral     diabetic therapy, they identified patients at high risk for hypoglycemia and then provided     in-person education to the providers of these patients. This resulted in a 68% reduction in     severe hypoglycemia (blood glucose < 40 mg/dL). This approach required significant personnel     hours and is difficult to replicate in other systems.      We will implement an EHR-based intervention at UCSF to predict which patients are at high     risk of inpatient hypoglycemia and take action to prevent the hypoglycemic event. In real     time, all adult (non OB) patients with a glucose < 90, and a high risk of future hypoglycemia     (based on the WSL formula) will be identified. Patients will be randomly assigned to     intervention or no intervention (current standard care). The intervention will consist of an     automated provider alert with recommendations on what adjustments could be made to avoid a     potentially serious hypoglycemic event.      The outcomes that will be measured include: 1) reductions in serious hypoglycemic events, 2)     monitor the changes made by providers as a result of alerts in order to study provider     behavior and identify future areas of intervention, and 3) provider satisfaction with the     alert system.   "
21321|NCT03006497|"     The aim of this study is to investigate the efficiency of an exercise program based on     principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic     patients.   "
21322|NCT03006484|"     Little is known about the long-term neurological outcomes after in-hospital cardiac arrest     (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence     rates of survivors with poor neurological status. Currently, withdrawal of care in comatose     patients after cardiac arrest is strongly forbidden by law in Korea. However, a new     legislation on allowing withdrawal of care will come into effect since early 2018 in Korea.     The investigators aim to determine 1) long-term neurological outcomes in patients who     developed IHCA, 2) whether early neurological status can predict late neurological status     after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes     will change since implementation of new legislation on withdrawal of care.   "
21323|NCT03006471|"     Prediabetes is defined as an intermediate metabolic state that leads to the development of     type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify     patients who are at risk of developing hypertension (AH), in both pathologies the     abnormalities in the variation of blood pressure (BP) has been related to organ damage, its     evaluation is performed by ambulatory blood pressure monitoring (ABPM).      Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter     type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of     glucose through the urine, in the way that glucose blood. Another reported effects is the     decrease on BP, so it would be interesting to evaluate this effects in patients with     prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent     progression to DM2 and HT, respectively.      The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood     pressure in patients with prediabetes and prehypertension without pharmacological treatment.      The investigators hypothesis is that the administration of dapagliflozin decreases     variability of blood pressure in patients with prediabetes and prehypertension without     pharmacological treatment.   "
21324|NCT03006445|"     The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981     administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the     method of multicenter, open label and ascending dose regimen.   "
21325|NCT03006432|"     Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from     cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a     cure. The vast majority of patients, however, present with advanced disease from the outset     (locally advanced or metastatic) or recurrent after resection of a localised form.      For metastatic or locally advanced stages of gastric or gastro-oesophageal junction     adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with     monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient     survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered as     one of the first-line chemotherapy treatment standards.      The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it     possible to improve the tumour response rate, the time to tumour progression and overall     survival in a randomised phase III trial. This improvement in treatment efficacy was     achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including     diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a     therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical     practice due to its high toxicity.      Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an     efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common     in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus     5FU-cisplatin was associated with a non-significant improvement in median progression free     survival rates, and overall survival.      All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better     tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than     5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of     development of chemotherapy protocols for metastatic gastric cancer, the question therefore     arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and     also tolerance.      In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in     advanced gastric cancer, but with progression-free survival and median survival rates that     are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2 every     2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results in     phase II studies in terms of efficacy and tolerability, and these are worth confirming     through a phase III randomised trial. In fact, if these results are confirmed in phase III,     TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while     limiting toxicity and preserving patients' quality of life, and could become the reference     treatment to accompany the targeted therapies currently being developed for this disease.      The primary objective of this randomised phase III trial is to compare the progression-free     survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with     5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or     oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the     tumour response rate, toxicity, quality of life and the therapeutic index, defined as the     ratio between the median progression-free survival and the febrile neutropenia rate.   "
21326|NCT03006419|"     Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed     graft function, slow graft function, biopsy proven acute rejection episodes, infections,     hospitalizations, adverse events, graft loss and death) than Basiliximab induction   "
21327|NCT03006406|"     Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which     can down-regulate pituitary function causing a temporary low estrogen state. Since     endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the     growth of endometriosis by inhibiting ovary function.Some scholars have found that, for     adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a     for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls     with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in     patients treated with GnRH-a for 1, or 2 months.   "
21775|NCT03000569|"     This study will assess the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in     up to 30 subjects with Parkinson's Disease of Moderate Severity.   "
21335|NCT03006302|"     This study will enroll patients who have metastatic pancreatic cancer and have progressed on     prior chemotherapy.      Half of participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX     pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207 (Arm A), while the other half     will receive epacadostat/pembrolizumab/CRS-207 (Arm B).      The primary objectives of this study are to determine the recommended dose of epacadostat in     this combination and assess survival of subjects in both treatment groups.   "
21336|NCT03006289|"     The purpose of this study is to investigate the association between metabolic syndrome (MS),     body mass index (BMI), hyperglycemia, dyslipidemia, hypertension and thyroid cancer. Screen     for the risk factors that affect the incidence of thyroid cancer.   "
21337|NCT03006276|"     Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being     conducted at multiple centers in the United States.   "
21338|NCT03006263|"     The purpose of this study is to explore clinical outcomes of totally laparoscopic versus     laparoscopy assisted total gastrectomy for gastric cancer.   "
21339|NCT03006250|"     The effects of desflurane versus sevoflurane in adult patients undergoing LMA anesthesia on     respiratory events during a less than 2-hour elective surgery.   "
21340|NCT03006237|"     A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001   "
21341|NCT03006224|"     Smoking and perhaps secondary smoking is associated with many perioperative and postoperative     complications, especially respiratory events. Hypoxemia and airway damage can be associated     with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway     damage during one lung ventilation for lobectomy.   "
21342|NCT03006211|"     To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated     under N2O + sevoflurane and O2 + sevoflurane general anesthesia.   "
21343|NCT03006198|"     The objective of this study is to explore and describe the disease characteristics, treatment     and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic     arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE,     SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle     East, and Western Asia.   "
21344|NCT03006185|"     Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser     versus microdermabrasion combined with large-area photodynamic therapy with methyl     aminolevulinate for actinic keratoses   "
21345|NCT03006172|"     This is an open-label, multicenter, Phase I study designed to evaluate the safety,     tolerability, and pharmacokinetics of GDC-0077 administered orally as a single agent in     participants with locally advanced or metastatic Phosphatidylinositol-4,5-Bisphosphate     3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutant solid tumors, including breast cancer, and     in combination with standard-of-care endocrine and targeted therapies for the treatment of     locally advanced or metastatic PIK3CA-mutant hormone receptor-positive (HR+)/human epidermal     growth factor receptor 2 negative (HER2-) breast cancer. Participants will be enrolled in two     stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants     will be assigned to one of four regimens: GDC-0077 as a single agent (Arm A), GDC-0077 in     combination with palbociclib and letrozole (Arm B), GDC-0077 in combination with letrozole     (Arm C), or GDC-0077 in combination with fulvestrant (Arm D).   "
21346|NCT03006159|"     This is a randomized, placebo-controlled, multiple dose escalation study to investigate the     safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be     conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be     randomized in each cohort to receive the study drug or placebo.   "
21347|NCT03006146|"     Autoimmune PAP is a rare lung disease affecting less than 5,000 individuals in US with no     FDA-approved pharmacologic therapy. Results from off-label use in case reports and clinical     studies completed outside of the US indicate that inhaled rhGM-CSF may be a safe and     effective thera-py for autoimmune PAP. Preliminary clinical trials of inhaled rhGM-CSF in     autoimmune PAP patients show promising results, 62%-96% therapeutic response rate without any     identifiable drug-related adverse effects in at least 73 autoimmune PAP patients. However,     the pharmacokinetics (PK), pharmacodynamics (PD), optimal dose, and treatment duration to     maximize efficacy are unknown.      The goal is to begin to address these knowledge gaps for inhaled sargramostim for autoimmune     PAP patients with a pilot safety and PK/PD study (TPSC-110). TPSC-110, PharmPAP, which is a     self-controlled open-label, phase I study to evaluate the safety, PK, and PD of inhaled     sargra-mostim in autoimmune PAP patients. These results will impact the field by 1)     confirming existing published data, 2) monitoring the local effects of inhaled sargramostim     in autoimmune PAP patients, 3) potentially demonstrating a safe starting dose for a later     trial to evaluate the therapeutic efficacy of inhaled sargramostim for autoimmune PAP.   "
21348|NCT03006133|"     The protocol is to show the prevalence of bruxism among a group of Egyptian children   "
21405|NCT03005392|"     -  Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL)          strengthens their physical fitness.        -  Exercising improves muscular and functional mobility fitness after finalizing          chemotherapy in children and teenagers diagnosed with ALL.        -  Assess cardiological changes   "
21349|NCT03006120|"     Bleeding complications after cardiac catheterization have been reviewed previously, but there     are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not     well defined. For this reason, the investigators aimed to analyze the clinical manifestations     of retroperitoneal hematomas in a single center using a case-control study design, to analyze     the treatment procedure determinants and consequently to provide an updated and usable     treatment algorithm.   "
21350|NCT03006107|"     to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative     pain associated with endodontic procedures.   "
21351|NCT03006094|"     The aim of the present study is to investigate and report on the psychometric properties of a     Greek version of the Chronic Pain Grade Questionnaire (CPGQ).   "
21446|NCT03005028|"     In the present study we aim at validating the computation of FFRangio values from the     angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a     completely blinded manner. Investigation of a wide range of users in various conditions may     strengthen the reliability of the FFRAngio measurements.   "
21352|NCT03006081|"     Retinal nonperfusion drives vision-threatening complications such as pathological     neovascularization, which can lead to neovascular glaucoma, vitreous hemorrhage, or     tractional retinal detachments and macular edema in diabetic retinopathy. Thus, decreasing     nonperfusion area with aid of anti-VEGF agents might be a useful way to prevent deteriorating     course of diabetic retinopathy. The main purpose of this study is to determine the efficacy     of intravitreal aflibercept injection in improvement of retinal nonperfusion and identify     associated factors in patients with nonproliferative diabetic retinopathy with moderate     retinal nonperfusion.   "
21353|NCT03006068|"     This study is designed to evaluate the long-term safety and efficacy of ABT-494 in     participants with ulcerative colitis (UC) who have not responded at the end of the induction     period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the     maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study     M14-234.   "
21354|NCT03006055|"     The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE     approved. Application data of CellCollector in China is not available now. The purpose of     this clinical trial is to confirm the validation and safety of CellCollector in Chinese     patients.   "
21355|NCT03006042|"     The transversus abdominis plane block (TAP block) is an effective method of postoperative     pain management after cesarean section (C-section). Up to now, there are no data available     about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the     investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP     block using BPV in parturients undergoing C-section and to report its effects on corrected QT     interval.   "
21356|NCT03006029|"     The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended     Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid     malignancies.   "
21357|NCT03006016|"     Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the     hiatal region during bariatric surgery. The doctors made a preliminary prospective study that     showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction     resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on     ultrasounds.      The aim of this study is to determine whether a 4-week preoperative course with omega-3     without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume     and its fat content, rendering thus surgery easier.      The primary end point is the reduction of the volume of the left liver lobe as measured by     magnetic resonance imaging.      Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver     injuries during surgery, and duration of surgery, the evolution of liver tests as well as the     correlation between preoperative MRI data and intraoperative liver biopsy for the     quantification of liver steatosis.      Study design: This is an interventional, prospective, multicentric, randomized, double     blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to     bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute     Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients     in 12 months.      Study time schedule: At the time of the enrollment visit two visits are scheduled, the first     before the beginning of the study and the last at the end. Surgery is scheduled no more than     7 days after the end of the treatment. At time of these two visits a clinical examination is     performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL     cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein)     and a MRI to evaluate the volume and the fat content of the liver. At time of surgery     duration of surgery and any eventual liver injury are recorded and a liver biopsy is     performed.      The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a     reduction in the volume of the left liver lobe of 20 %.      Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in     a significant reduction of liver volume and steatosis before bariatric surgery, it may be     recommended as a systematic preoperative treatment.   "
21358|NCT03006003|"     The study will be conducted to assess the depressive symptoms and related markers in the     postmenopausal female after anti-osteoporosis treatment.   "
21359|NCT03005990|"     This study will explore the long-term effects of exercise training on body composition,     cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep     disturbances   "
21360|NCT03005977|"     What test is most sensitive in identifying stress urinary incontinence in women with pelvic     organ prolapse; urodynamics, cough stress test, or pyridium pad test? The hypothesis states     that there is a difference between the sensitivity of UDS, pyridium pad test and cough stress     tests, with UDS being the most sensitive and the gold standard in identifying SUI in patients     with pelvic organ prolapse.   "
21361|NCT03005964|"     To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the     treatment of plaque psoriasis   "
21362|NCT03005951|"     The purpose of this study is to see what effect skipping breakfast versus consuming breakfast     has on cognitive performance and the hormones responsible for glucose homeostasis in lean and     obese adolescent males. The subjects will be tested on their ability to maintain attention     when given several tasks called continuous temporal expectancy tasks (CTET) and     electrophysiological signals using electroencephalogram (EEG) will be monitored. These two     study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast     intervention and B = no breakfast. There will be a washout period of 7 days in between study     visits.   "
21363|NCT03005938|"     The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on     the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy.      Effect of SM and imitation of the SM has to be compared in the double-blinded randomized     clinical trial.   "
21404|NCT03005405|"     This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions     moderate caries using sealants as an alternative to the restorations on occlusal surfaces of     deciduous teeth. Initially, a non-inferiority study was designed in order to verify if     sealing could be non-inferior than restoration. In this case, it could be preferable since it     is less invasive. Therefore, cost will be put forward into the analysis considering even     reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability     could be another differential point between treatments.   "
21364|NCT03005925|"     Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting     nearly 0.4% of the general population. It is a real public health issue. International     guidelines recommend strict control (remission or low disease activity) of the disease, to     avoid joint destruction in order to reduce the functional impact of the disease in the long     term and to improve the quality of life of the patients.      This care is based on a close follow-up requiring regular visits with the specialist which     represents an additional cost (transport, visits). In this context, tele-medicine is often     proposed as a complementary approach in the management of these chronic patients.      Thus, the investigators propose to study the interest of a connected device by comparing a     group of patients using this Smartphone application, coupled with a hand dynamometer during     the 6 months following initiation of a new DMARD.   "
21365|NCT03005912|"     Despite modern hearing aids such as cochlear implants, speech comprehension during telephone     conversation is challenging for hearing-impaired patients. On the one hand, conventional     telephones transmit a limited spectrum of the acoustic signal compared to a normal     conversation. On the other hand, lip reading during a phone call is generally not possible.     As a result, speech comprehension during a telephone conversation is reduced. In previous     studies, the authors demonstrated an improved speech comprehension for hearing-impaired     patients using voice-over internet protocol (VoIP) telephony (Skype) compared to conventional     telephony.      New bluetooth-enabled hearing aids allow for direct transmission of the telephone signal to     the hearing device. As the direct transmission is expected to improve signal-to-noise ratio,     speech comprehension is tested in patients with bluetooth-enabled hearing aids for 4     different scenarios: 1. conventional telephony without bluetooth device 2. conventional     telephony with bluetooth device 3. VoIP telephony without bluetooth device 4. VoIP telephony     with bluetooth device   "
21366|NCT03005899|"     This is a Phase 3 clinical trial to compare the safety and efficacy of SyB P-1501 with the     SyB P-1501 placebo for the management of the first 24 hours of post-operative pain.   "
21367|NCT03005886|"     The aim of this study was to evaluate the effects of periodontal treatment on gingival     crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1) in     chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to     systemically healthy CP patients. The investigators' hypothesized that severe CP may play a     role in initiating or exacerbating MI and there is an increased risk for AMI among     systemically healthy persons affected with severe CP.   "
21368|NCT03005873|"     This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study     to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.   "
21369|NCT03005860|"     Surgery, perioperative stress, anaesthetics and analgesics may modulate the     immunosurveillance mechanisms and overwhelm host defences that normally maintain a balance     between immunity & carcinogenesis. This may lead to escape of cancer cells and tilt the     scales toward a more protumorigenic microenvironment. Volatile agents, in particular, have     been shown to exhibit profound immunosuppressive effects. In comparison, propofol has a     favorable profile and inhibits cancer cell activity. Determining cancer-protective role of     TIVA with propofol presents an exciting window of opportunity that has potential to improve     outcomes in cancer patients undergoing resection surgery   "
21370|NCT03005847|"     Fermented papaya preparation has been reported to bind and neutralize reactive oxygen species     as well as iron. Patients undergoing hemodialysis are generally on iron overload status due     to their inability to use iron storage adequately. The aim of this study is to evaluate the     effect of FPP on the iron status of these patients.   "
21371|NCT03005834|"     Because of the genetic and traditional commonalities between the underlying causes of     atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with     atherosclerotic CVD may have a high incidence of cancers when compared with those with     non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical     outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara Health     Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of     improving healthy life expectancy in patients with CVD in our institute.   "
21372|NCT03005821|"     The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an     add-on therapy while comparing with sham massage both on the basis of usual care for 0-6     years old children with acute diarrhea.   "
21373|NCT03005808|"     Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall     and the parietal peritoneum. The TAP block could advange the postoperative pain of     Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s     concentration to improve postoperative pain in Appendectomy in children. We propose a     randomized trial that compares 3 groups children submitted Appendectomy in children between 6     and 16 years. The control group has received no blockade, the other two groups have received     TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.   "
21374|NCT03005795|"     To assess the effect of music during colposcopy on women´s anxiety.   "
21375|NCT03005782|"     In dose escalation: safety and PK In dose expansion: response rate   "
21376|NCT03005769|"     This is an observational, retrospective, non-interventional study that will include     schizophrenic patients who were initiated with aripiprazole once-monthly as per normal     clinical practice at least 6 months before the data collection starts (inclusion visit), and     is designed to evaluate demographic and clinical predictors of persistence with this     treatment.      Data from each patient will be collected after informed consent is signed (inclusion visit),     and will include retrospective information from the start of aripiprazole once-monthly     treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months     after the index date). Data will be retrospectively collected from all visits occurring as     per clinical practice (usually once monthly).   "
21377|NCT03005756|"     The needle guiding robot helps targeting of radiofrequency ablation needles by matching     computed tomography images and patients' bodies. Actual insertion of needles will be     performed by doctors. This study evaluates the safety and efficacy of needle targeting on     patients with hepatocellular carcinoma.   "
21378|NCT03005743|"     Purpose of the study is to determine whether Image based brachytherapy is superior in terms     of local control to Conventional radiograph based brachytherapy in locally advanced cervical     cancers in a Phase III randomized setting.   "
21421|NCT03004196|"     Orthodontic appliance causes increase in plaque accumulation, especially around brackets,     wires and attachments. Advances in orthodontics in recent time have led to improved quality     of appliance and treatment procedures ultimately resulting in improvised standard of patient     care.      These bacteria metabolize different kind of carbohydrates accumulated around orthodontic     appliances and create acidic environment in the oral cavity leading to enamel     demineralization around the brackets and white spot lesions.      This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and     chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are     not using them.   "
24649|NCT02963038|"     Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and     efficacy in patients with B cell malignancy including lymphoma or leukemia.   "
21379|NCT03005730|"     Background: According to the International Association for the Study of Pain (IASP), the term     temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which     include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck     on one or both sides as well as joint sounds, limited mandibular movements or mandibular     deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and     light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain.     Thus, there is a need to investigate therapeutic resources that combine different wavelengths     as well as different light sources (LLLT and LED) in the same apparatus.      Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain,     activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint     mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine     the cumulative effect 24 and 48 hours after a six session.      Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be     carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous     TMD. The participants will then be randomly allocated to two groups totaling 15 individuals     per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one     group will receive placebo therapy (0 Joules). The following assessment tools will be     administered on four separate occasions (baseline and immediately after, 24 h after and 48 h     after phototherapy). Pain intensity will be assessed using the visual analog scale for pain,     meter for range of movement, and electromyographic EMG analysis on the masseter and anterior     temporal muscles.      Discussion: The study will support the practice of evidence-based to the use of phototherapy     in individuals with a myogenous TMD. Data will be published after the study is completed.   "
21380|NCT03005717|"     Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to     evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on     submental bulging due to subcutaneous fat. Approximately 150 participants of either gender     who have a Moderate Bulge or Large Bulge in the submental fat (on Patient-Reported     Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS])     will be recruited for this study.   "
21381|NCT03005704|"     The specific objective of this study is to investigate the potential for normal platelets to     reverse the inhibition of platelet aggregation in patients treated with ticagrelor in     combination with aspirin.   "
21382|NCT03005691|"     The purpose of this study is to determine whether the metabolite concentrations within the     anterior cingulate cortex and periaqueductal gray matter predict the intensity and     interference of neuropathic pain after the development of chronic whiplash syndrome.   "
21383|NCT03005678|"     A randomized controlled trial to compare for the efficacy and tolerability of denosumab and     oral alendronate in the management of glucocorticoid induced osteoporosis   "
21384|NCT03005665|"     The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube     on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.   "
21385|NCT03005652|"     The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate     the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective     Cognitive Decline (SCD), in comparison to an active comparison condition.      It is increasingly recognized that most neuropathological processes start years before the     onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target     individuals in the earliest stages for intervention when neurodegeneration is still limited.     Individuals clinically judged to have SCD, defined by subjectively experienced cognitive     decline but normal performance on cognitive tests, are at increased risk for future cognitive     decline and AD. These individuals with SCD currently have no established treatment options.     Symptoms of anxiety have high prevalence in this population, and evidence from recent     longitudinal research links anxiety with significantly accelerated cognitive decline in at     risk individuals. Effectively reducing anxiety in this population may therefore not only     relieve participants from burdensome symptoms, but may also slow cognitive decline and delay     or prevent the onset of AD.      The investigators chose to study the efficacy of a mindfulness-based intervention to reduce     anxiety in this population because this type of intervention has been shown to reduce anxiety     in a number of populations, including in older adults. Further, accumulating evidence     indicates that intensive mindfulness training effectively down-regulates a number of other     adverse psychological and biological risk factors for AD, such as stress, depression,     insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These     findings are relevant to AD because approximately a third of AD cases worldwide might be     attributable to potentially modifiable risk factors. In spite of the increased use of     mindfulness-based interventions to treat clinical symptoms, these trials often suffer from     the lack of an adequate comparison condition and lack of follow up to know whether initial     benefits are maintained.      SCD-WELL includes both an active comparison condition and a 16-week follow up assessment     after the end of the intervention. SCD-WELL is a non-CTIMP European multicentre,     observer-blinded, randomized, controlled, superiority trial with two parallel groups, which     compares anxiety and additional behavioural and biological outcomes amongst people with SCD     who receive mindfulness-based training and those who receive a health education comparison     intervention. Outcomes will be measured at baseline, post-intervention and 16 weeks after the     end of the intervention.      160 older-adult patients diagnosed with SCD will be recruited to the study from memory     clinics at four sites in Europe: London, UK; Cologne, Germany; Barcelona, Spain; Lyon, France     where they will have sought help due to concern about their memory. Participants will be     recruited in two waves over a maximum two-year period and will be provided with a participant     information sheet, and asked to consider their participation. Should they wish to     participate, and after a signed and dated Informed Consent Form has been obtained, a unique     participant identification (ID) will be assigned to the participant.      Behavioural assessments will take place at baseline, after the intervention, and 16 weeks     after the end of the intervention. Because we believe that mindfulness-based training has the     potential to affect a number of areas of life we will also look at changes in other areas of     psycho-affective symptoms, social functioning, awareness, well being and quality of life,     sleep quality, and cognition, after the intervention and 16 weeks after the end of the     intervention. Validated neuropsychological tests and behavioural questionnaires were selected     for their sensitivity to the domains listed above. These measures will be completed alone by     the participant or in the presence of a psychometrist. Questionnaires will also be completed     by partners at the three time points to coincide with assessments of participants.      Blood samples will be taken at the memory clinic by certified phlebotomists at baseline,     after the intervention and during follow-up to measure genetic markers of risk for AD as well     as proteomic markers of stress and AD that may be affected by this intervention. Information     will also be collected about the medical care of the participant.      Trained facilitators will deliver both interventions. Both interventions follow a manual, are     group-based, include at-home activities, and are 8 weeks in duration. Both interventions     provide individuals with sustainable skills that remain beyond the intervention period.   "
21386|NCT03005639|"     Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma      • To evaluate the overall radiological complete response rate in patients with stage IIIB/C     melanoma after 8 weeks of neoadjuvant vemurafenib and cobimetinib   "
21387|NCT03005626|"     We aim to measure the impact of a transition program in congenital cardiology in terms of     health-related quality of life.   "
21388|NCT03005613|"     A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between     Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.   "
21389|NCT03005600|"     Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common     obstetric medical conditions which when undetected can cause significant adverse outcomes for     the mother and the offspring. Diagnosis is typically made between 24-28 weeks of pregnancy     using oral glucose tolerance test (OGTT). Therefore, some damage might have already happened     prior to detection. Although universal screening is recommended by many guidelines, this is     not uniformly followed across the world, partly because of doubts about cost-effectiveness.     Only selective screening is followed based on presence of at least one of the high risk     factors (age, BMI, previous history, etc). This strategy can miss up to 50% of GDM. In     addition, no data exists in India and Kenya. In low and middle-income countries (LMICs),     where majority live in rural settings, the major limitations are difficulty in conducting     OGTT, which requires prompt access to laboratory facilities. Combining the clinical and     easily analysable biochemical markers (composite risk score) could improve the prediction and     if proven, could help to prevent the onset of GDM. Fasting glucose levels (at non-diabetes     levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy can be a better     marker as it can be done point-of-care and does not require patients to be in a fasting     state. The overall objective of the proposed project is to develop a composite risk score to     predict GDM in early pregnancy using a combination of easily identifiable risk factors such     as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and Kenyans. The     project will recruit pregnant women in early pregnancy from South India (n=3400) and Western     Kenya (n=4000). Contribution of individual risk factors as well as the composite risk score     on the risk of developing GDM will be assessed. Detailed health economic analyses will enable     policy makers to make informed decision based on local data.   "
21390|NCT03005587|"     This a prospective observational study in Chronic Liver Disease patients admitted or seen in     OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will     be conducted in a period of three months starting September 2016 in sample size of 80 . A     detailed proforma including history and examination and routine blood investigations will be     noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar     activities will be repeated at every visit.   "
21391|NCT03005574|"     The purpose of this study is to determine if using a tablet computer, which is a very small,     easy-to-carry computer, to practice thinking exercises at home will help improve your     attention, memory, and problem solving abilities. All the participants will receive training     in the thinking skills for work program. But in order to determine the effect of tablet use     for home practice, half of the participants will be given a tablet to practice the thinking     exercises at home. All participants will be receiving vocational rehabilitation and have a     goal of getting a job.   "
21402|NCT03005431|"     Manitoba parents of preschool children newly diagnosed with Autism must wait up to a year to     receive government funded services for their child. During this delay parents need support     and training to promote their child's development. The purpose of this research is to develop     and evaluate an on-line, parent training and support program that will assist parents during     this time. It is predicted that if parents receive on-line training and support they will     increase their parenting knowledge and skills, reduce their stress, and create better     outcomes for their child, in comparison to parents who do not receive the training. The     experimental study (n=60) will use a randomized, masked, waitlist control design that     compares a treatment group to a control group. Descriptive statistics will be used to     describe differences between groups, ANCOVA's to test for differences between groups, and     Pearson correlations to describe the relationship between parent stress and outcomes.   "
21392|NCT03005561|"     In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to     treat problems such as GH deficiency, chronic renal failure and Turner syndrome and     Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate     growth to close the gap in the average population and reach a final height is normal, while     minimizing risks and costs.      Noncompliance to treatment with GH is common; Other estimates are that one third to one half     of patients do not comply with the provisions as require. This may result in linear growth     depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and     higher costs.      Many studies have been devoted to locating factors make it difficult to adhere to their     chronic diseases in children, including conditions that require treatment with GH.      Pain is the primary cause for difficulties. In recent decades, many resources were devoted to     research and development of ways of dealing with pain in all aspects.      In order to implement all of the information collected, appropriate interventions medium     should be found; In this study we intend to use the method of playback. Playback define that     improvisation as a theater facilitator asks the audience to share moments, feelings and     stories of his daily life, and a group of actors improvise their stories in front of the     stage as a kind of play-back. Unlike hobbies such as sports or singing, the method allows     not only to unload the tensions but also communication and collaboration. It is very     reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.      Assumption:      Intervention of two playback meetings during the year will uncover the difficulties and     engage ways of dealing with pain. That will reduce the difficulties caused by GH injections     and improve compliance to treatment.   "
21394|NCT03005535|"     This will be a randomized clinical trial carried out on subjects with suboptimal control of     cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E     vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9   "
21395|NCT03005522|"     An individual's quality of life can be seriously affected by the severity of dental pain. The     emergency department is a common place to find those seeking relief from their dental pain-     often times seeking removal of the affected tooth, dental anesthetic injections or oral pain     medications. There are a number of dental infections that cause this type of debilitating     pain. One such dental infection is termed periapical abscess. This infection involves the     tooth pulp. These infections can arise in three ways: introduction through a defect in the     enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of     the pulp from mechanical irritation. As this disease process continues there are a number of     complications including chronic pain and, more seriously, the spread of infection into deep     spaces which can be a life threatening condition.      The Emergency Department treatment of this infection includes pain control, antibiotics and     dental referral for ultimate management of the infection.      The purpose of our study is to investigate whether the addition of oral steroids will alter     the time until patient experiences improvement in their dental pain. Steroids are a commonly     used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief     from throat pain. As the pain from periapical infection is thought to be largely from the     pressure we speculate that the anti-inflammatory effects of steroids may decrease the     inflammation thus the pressure and may ultimately lead to a decrease in time until the     patient experiences some relief from their pain.   "
21396|NCT03005509|"     A prospective before-and-after study to evaluate the effect of implementing a Trauma Quality     Improvement protocol on the process of Trauma Quality Improvement meetings and major trauma     patient outcomes at four trauma centres in India.   "
21397|NCT03005496|"     This study is a randomized controlled trial which compares the effect of zinc, beta-carotene,     and Vitamin D3 supplementation in pregnant women which has preterm birth. The measured     outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and     IL-1β levels in placenta.   "
21398|NCT03005483|"     This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral     10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in     children from 3 months to 16 years submitted unilateral limb surgery.   "
21399|NCT03005470|"     National and international guidelines that guide evidence-based clinical practice advocate an     effort to improve blood pressure control based on changing lifestyle and use of blood     pressure lowering medication. However, the effectiveness of the approach usually depends on     patient adherence to both types of interventions - pharmacological and behavioral. Lack of     success on blood pressure control has increased the scope of interventions to improve     adherence and to reduce cardiovascular risk factors without overburdening the public health     system. The use of technologies - mobile or smart phones, games, blogs, internet and video     conferencing - to implement interventions can reduce costs and increase coverage.      Interactive interventions have been associated with a reduction in systolic blood pressure of     3-8 mmHg in patients with hypertension. These interventions were individually tailored to     patient specificities and involved self-monitoring of blood pressure and lifestyle changes,     including regular physical activity, DASH diet, restriction of dietary salt intake, and     weight control. However, the effectiviness of these interventions may have short half-lives     without periodic reinforcement, either to adhere to pharmacological treatment or behavioral     changes. Innovative technologies can be used to achieve lasting effect and even greater blood     pressure reduction.      Therefore, the purpose of this study is to compare effectiveness of four strategies to reduce     blood pressure and improve lifestyle.   "
21400|NCT03005457|"     Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant,     game-based CI therapy. Pre/post study design. Participant received a target of 30 hours     game-based motor intervention, 100 hours constraint of the less affected upper extremity, and     5 hours therapist consultation (including completion of a behavioral contract at the first     study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and     post-treatment testing performed within 1 week prior to and 1 week post-intervention by an     independent tester.   "
21401|NCT03005444|"     Liver cirrhosis has traditionally been seen as a state of hypocoagulability and can be     protected against thrombosis. However, recent studies have completely changed this paradigm.     Patients with liver cirrhosis have an impaired hepatic synthesis of procoagulation factors     but also anticoagulation factors, which is associated with an increase in other procoagulant     factors such as factor VIII and von Willebrand factor which determines an elevated thrombin     generation and, ultimately, a hypercoagulability state. Several consequences of     hypercoagulability can be expected, such as portal vein thrombosis and venous     thromboembolism. In addition to the potential direct deleterious consequences for the     development of portal vein thrombosis, recent data have shown a close relationship between     the activation of coagulation and faster progression of liver fibrosis.      Bacterial translocation is a common problem and plays an important role in the pathogenesis     and complications in patients with decompensated cirrhosis, including infections as well as     hepatic encephalopathy and hepatorenal syndrome. To date, several biomarkers of BT have been     proposed, which include bacterial DNA, soluble CD14, lipopolysaccharides endotoxin,     lipopolysaccharide-binding protein, calprotectin and procalcitonin. Besides, endotoxemia and     activation of the TNFa-pathway may be also considered key components in the pathogenesis and     aggravation of portal hypertension and its complications.      Anticoagulation therapy has a beneficial effect on survival in patients with idiopathic     pulmonary fibrosis. Besides, a pilot study showed that the use of anticoagulants warfarin for     8 weeks improved the liver elasticity determined by Fibroscan® (Dhar A, et al. J Hepatology     2012. Abstract). An ongoing study of warfarin for the prevention of fibrosis due to recurrent     hepatitis C should also contribute to an understanding of the role of the haemostatic system     and fibrosis (http: //www.controledtrials.com/IRSCTN12504151).      On the other hand, a recent prospective study in a group of 70 patients with liver cirrhosis     (Child B and C stages up to 10 points) who were randomized to receive enoxaparin for a year     (n = 34) vs no intervention (n = 36) showed that anticoagulant treatment with enoxaparin is     safe and effective, significantly reducing risk of PVT development and liver decompensation,     markedly improving overall survival. This study provides exciting preliminary data regarding     the potential use of prophylactic anticoagulation in improving clinical outcomes in     cirrhosis, beyond the prevention of portal vein thrombosis. This study suggested that the     effect was partly due to a direct effect of reducing BT and levels of proinflammatory     cytokines. However, this study included few patients, was not double blind, and did not have     a placebo group. Therefore, despite the spectacular results, the use of prophylactic     anticoagulant therapy has not become routine practice in patients with cirrhosis and more     studies are needed to assess the potential usefulness of anticoagulation in improving the     prognosis of liver cirrhosis.      Transjugular intrahepatic portosystemic shunts (TIPS) are now routinely used to treat the     complications of portal hypertension, such as variceal bleeding and refractory ascites. TIPS     is the most effective method to prevent rebleeding, however, it is burdened with increased     risk of hepatic encephalopathy and deterioration of liver function in patients with advanced     cirrhosis. Notably, TIPS can not only relieve portal pressure but also can redirect the     portal blood flow through the shunt directly into the systemic circulation which can cause     systemic hemodynamic changes.      Given the preliminary data suggesting a beneficial effect of prophylactic anticoagulation     with LMWH in cirrhotic patients, this multicenter randomized controlled study attempts to     demonstrate the effect of long term LMWH therapy after TIPS on survival in cirrhotic patients     with variceal bleeding.   "
21403|NCT03005418|"     This study evaluates the use of the Human Acellular Vessel (HAV) in adults with arterial     trauma in the lower limb who are undergoing vascular reconstructive surgery. All subjects     will be implanted with a HAV as an interposition vessel or bypass using standard vascular     surgical techniques. There is no control arm.   "
21422|NCT03004183|"     This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation     therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment     before pembrolizumab in patients with metastatic triple negative breast cancer (TNBC) and     metastatic non-small cell lung cancer (NSCLC). In situ oncolytic virus therapy will consist     of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus     valacyclovir therapy.   "
21407|NCT03005366|"     -  The main objective of this project is to study the efficacy and the mechanistic value of          blocking both atrial specific and atria-preferential dynamics of ionic currents to          terminate paroxysmal atrial fibrillation (AF).        -  The hypothesis is that a drug blocking atrial specific and atria-preferential dynamics          of ionic currents (IK,ACh - acetylcholine sensitive K+ current - and INa - inward sodium          current - , respectively) will be more effective to terminate paroxysmal AF episodes          with fast atrial activation rates, than a classical INa blocker, which will be more          effective to terminate AF episodes with slower activation rates.        -  The investigators will include patients without structural heart disease and          short-lasting AF episodes (<48 h.). Double blind and single center study, in which          patients will be randomly assigned to a cardioversion group using intravenous flecainide          or to an atria-preferential and atrial-specific blockade group using intravenous          vernakalant. Patients will be routinely monitored in the electrophysiology room to          acquire both 12-lead digitized ECG signals and non-invasive body surface potential          mapping. Atrial signals will be extracted from both the multisite body surface and ECG          recordings to obtain temporal and spectral parameters, and measure organization and          atrial rate in both groups. The results obtained in the clinical setting will be studied          in mathematical models to understand their capability to terminate paroxysmal AF. The          project expects to provide consistent, reliable and reproducible parameters that will          assist clinicians to know what type of paroxysmal AF episodes will be more suitable to          effectively terminate, upon administration of drugs with an atrial specific and          atria-preferential profile.   "
21408|NCT03005353|"     Fungal infections have increased over the last two decades, largely because of the increasing     size of the population at risk, including patients who are immunocompromised, broad-spectrum     antibiotics and intravascular catheter users. Essential oils and other extracts of plants     have evoked interest as sources of natural products. They have been shown to possess     antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of     our knowledge, no study has examined the efficacy of cumin seed extract on relieving     vulvovaginal candidiasis in vivo.   "
21409|NCT03005340|"     Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study     to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215     and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy     male volunteers   "
21410|NCT03005327|"     The overall objective is to evaluate X4P-001 in the treatment of patients with WHIM Syndrome.   "
21411|NCT03005314|"     Esophageal carcinoma is a common digestive system tumor, with number of deaths ranking No. 4     in malignant tumors. Esophageal squamous cell carcinoma in stage Ⅱ, III is the most common in     China. The esophageal cancer during these stages is no longer localized lesions, and cancer     will be transferred to other organs of the body through blood transmission, leading to tumor     metastasis, which is the main cause of the patients' death. The tumor cells invade the     surrounding tissues of primary tumor cells and enter the blood and lymphatic system, thus the     circulating tumor cells (CTC) is formed and transported to a distal tissue, then effusing,     adapting to the new microenvironment and finally forming metastases through the process of     seeding, proliferation and colonization.      Recently, the controversy of surgical treatment of esophageal carcinoma is concentrated on     the neoadjuvant therapy during perioperative period. NCCN guideline of 2015 recommended that     patients with esophageal squamous cell carcinoma in T1b, N + and T2-T4a, N0-N + may consider     preoperative neoadjuvant therapy, but its supporting literature (David Cunningham 2006, Marc     Ychou 2011 and P. van Hagen, 2013) includes patients with pathology of the type     adenocarcinoma. The esophageal cancer treatment guidelines of Japan 2015 adopted the opinion     of NCCN Guidelines, and recommended neoadjuvant chemotherapy and radical surgery as the     standard treatment for stage II and III esophageal cancer patients based on the results of     randomized controlled clinical trial JCOG9907. However, the guidelines also pointed out that     the role of neoadjuvant chemotherapy for resectable T1-3N0-1M0 cancers remains unclear     according to the results of some meta-analysis.      The investigators choose the detection of peripheral venous blood CTCs and the disease-free     survival as the main index, to compare the treatment effect of patients, those received     neoadjuvant therapy, surgery and those received directly surgery, postoperative chemotherapy     with esophageal squamous cell carcinoma in stage Ⅱ, III by means of evidence-based medicine;     Define the indication of neoadjuvant chemotherapy in the treatment of esophageal squamous     cell carcinoma in stage Ⅱ, III; Draft the solution to evaluate the treatment effect of     neoadjuvant chemotherapy to esophageal cancer in stage Ⅱ, III, and the indication of     neoadjuvant chemotherapy by test the peripheral venous blood CTCs and join the Chinese     clinical guideline.   "
21412|NCT03005301|"     The present study is a prospective, two-center, randomized, controlled, open-label,     non-inferiority trial evaluating the efficacy and safety of a new intelligent     electroacupuncture instrument in treating neck pain caused by cervical spondylosis.   "
21413|NCT03005288|"     This study will assess the safety, pharmacokinetics and efficacy of bimagrumab when     administered in overweight and obese patients with type 2 diabetes   "
21414|NCT03005275|"     In polycystic ovary syndrome (PCOS) patients, both in vitro maturation (IVM) and     intra-cytoplasmic sperm injection (ICSI) are indicated as optional treatments. Although     recently ICSI techniques have been reported as more successful the IVM in achieving     pregnancy, they have also become much more expensive for the couples involved. Whilst most     high-income countries offer Assisted Reproductive Technology (ART) procedures fully or     partially paid by the government, the patients in low or middle-income countries have to     cover self-fund infertility treatments. With limited resource, a study conducting based on     the prevalence - based cost - effectiveness analysis is necessary for health managers, policy     makers and especially to assist patients' decision making in these countries.      However, there are still limited published studies that have evaluated the cost-effectiveness     of these strategies are available in the literature. This study is conducted based on the     prevalence - based cost - effectiveness analysis from the patient's perspective. Activity -     based costing method is used to cost in all levels of the healthcare system, which the     patients have to pay directly or indirectly. It also analyses incremental cost -     effectiveness to evaluate the cost - effectiveness of IVM and ICSI in PCOS women.   "
21415|NCT03005262|"     To allow a patient continued access to MLN8237   "
21416|NCT03005249|"     To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.   "
21417|NCT03005236|"     The proportion of elderly patients with end-stage kidney disease undergoing renal replacement     therapy (RRT) is steadily increasing. Although kidney transplantation remains the optimal RRT     of choice, it is clear that older adults have a differential risk versus benefit profile     after kidney transplantation compared to younger adults. No age-adapted immunosuppression for     older adults has been shown to improve kidney allograft outcomes but recent sub-analyses of     clinical trial data has hinted at improved outcomes for older kidney transplant patients     receiving Envarsus versus standard twice-daily tacrolimus formulations. This feasibility     study will investigate this effect to see whether a full scale randomised controlled trial is     warranted and to provide information regarding study feasibility.   "
21418|NCT03004235|"     The purpose of this study is to collect non-invasive observational data in suspected or known     carbon monoxide poisoning.   "
21419|NCT03004222|"     The purpose of this research is to determine if spraying a local anesthetic to the cecum     after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed     after surgery and reduces the time to discharge from the hospital.   "
21420|NCT03004209|"     This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis.     Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.   "
21425|NCT03004144|"     This study is a cross-sectional study investigating the impact of assistive forces applied by     the body-weight support system the FLOAT on the study participants. The study is conducted     at the University Hospital Balgrist in Zurich over a period of around 3 years. During this     time measurements on approximately 120 able bodied subjects and 20 patients with an     incomplete spinal cord injury will take place. The study participants are invited for a     single visit of around 140 min duration to the University Hospital Balgrist. During this     visit the study participants will repeatedly perform various activities of daily living (free     walking, standing up and sitting down, stair climbing and balancing) with and without     assistive forces from the body-weight support system. While performing the tasks, the study     participants' motions and muscle activities will be measured to evaluate the naturalness of     their movements. In addition, the collected data permits us to compare different movement     patterns and make conclusions about effective and optimal movement support. Obtaining this     knowledge will help us to shape the therapy of these activities to be tailored to the     patients and to train these movements with the help of the FLOAT under optimal conditions.   "
21426|NCT03004131|"     This study is to assess the onset of action of fixed drug combination of azelastine     hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal     symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an     Environmental Exposure Chamber (EEC).   "
21427|NCT03004118|"     The investigators aim to evaluate ursochol as a therapy in functional dyspepsia. The     objectives of the study are to evaluate the effect of ursochol on duodenal permeability and     dyspeptic symptoms and on duodenal low-grade inflammation, bile acid composition, bile acid     receptor expression, nutrient tolerance and intragastric pressure.      Cross-over, controlled, randomized, double blinded, placebo-controlled trial with a 4 week     intake of ursodeoxycholic acid (ursochol) versus a 4 week intake of placebo and a 4 week     washout period in between. Two study days are planned during week 4 and week 12. During the     14 weeks, the patients have to fill in a diary. And for 14 weeks in total, the patients have     to discontinue intake of proton pump inhibitors, drugs effecting gastric motility and NSAIDs     and replace their oral anticonception with non-oral anticonception. Every two weeks of the     study the investigator will call the participants to see how they are/if they have any     discomforts or side effects.   "
21428|NCT03004105|"     The goal of this clinical research study is to learn if MEDI4736 given in combination with     selumetinib can help to control advanced lung cancer.      The safety of this drug combination will also be studied.   "
21429|NCT03004092|"     Diagnosis of invasive aspergillosis remains difficult, and is often based on a combination of     patient characteristics, radiological and microbiological findings. To data, galactomannan     (GM) is the only well-validated biomarker available. However, GM still has its shortcomings.     There is therefore a need for new, complementary biomarkers. In this study, two of those     tests, bis(methylthio)gliotoxin (bmGT) and a lateral flow device, will be validated in a     hematological population, and compare it to GM.   "
21430|NCT03004079|"     The purpose of this study is to assess the relationship of blood glucose levels in persons     with Multiple Sclerosis (MS) who have experienced a relapse and will be receiving intravenous     steroids for the relapse, to their recovery from the relapse.      Steroid exposure commonly leads to elevated serum blood glucose, however, standardized     monitoring of blood glucose levels in the outpatient setting is not common. The clinical     impact of any associated elevated blood glucose during steroid administration is unknown. We     hypothesize that the blood glucose response to steroid treatment is clinically relevant to     the MS-relapse recovery.   "
21431|NCT03005223|"     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155     / DWC20156 and DWC20163 in Healthy Volunteers   "
21432|NCT03005210|"     Comparative randomized, single dose, three way three sequence two treatment partial replicate     crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from     Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets     (Gilead Sciences, Canada) in Healthy Human Volunteers Under Fed Condition.   "
21467|NCT03004755|"     Historically, cancer research has been limited by sample acquisition in late stage disease,     often restricted to single sites of disease with limited parallel clinical data collection in     terms of prior therapy exposure. The PEACE study is intended to facilitate tissue donation     from multiple tumour sites in the post-mortem setting and enable future research using     samples collected at post-mortem within different disciplines related to cancer research.   "
21433|NCT03005197|"     Teeth injuries are considered one of the most challenging events that occur in dentistry,     especially in children. After an injury, there is a possibility that the blood supply to the     tooth may become affected and compromised leading to nerve and blood vessels death with the     tooth described as a non-vital tooth.      The conventional diagnostic tools available to assess tooth nerve/blood supply are not always     reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure     to assess the vitality of the tooth may result in pain, swelling or infection of the tooth or     de-vitalising a normal tooth which may render the tooth weak for the future and possibly     losing the tooth.      The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more     reliable than the traditional techniques. We aim to assess if this device can predict and     assess whether the tooth is alive or dead during the follow up visits of the injury along the     other conventional tests.   "
21434|NCT03005184|"     This study tests the hypothesis that endogenous bradykinin contributes to effects of a     combined angiotensin receptor blocker/neprilysin inhibitor (LCZ696 or Entresto)   "
21435|NCT03005171|"     The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in     patients undergoing open upper abdominal surgery; when compared with thoracic epidural     analgesia. Half of participants will receive intravenous lidocaine infusion, while the other     half will receive thoracic epidural bupivacaine infusion.   "
21447|NCT03005015|"     The primary objective of this multicenter, randomized phase II trial is to assess the     efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to     doxorubicin in advanced or recurrent endometrial cancer.      The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib     activity and establishing a cutoff value as potential selection criteria for phase III.      Other secondary objectives are to assess the tolerability and safety of lenvatinib in this     setting and overall survival, response and disease control.   "
21436|NCT03005158|"     Patients with suspected acute coronary syndrome account for a tenth of all presentations to     the Emergency Department and up to 40 per cent of unplanned hospital admissions. The majority     of patients do not have a heart attack (myocardial infarction), and may be safely discharged     from the Emergency Department.      The investigators propose to evaluate whether the use of the HighSTEACS pathway in patients     with suspected acute coronary syndrome reduces length of stay and allows more patients to be     safely discharged from the Emergency Department. This pathways utilizes high-sensitivity     cardiac troponin I testing and will rule out myocardial infarction if troponin concentrations     are <5 ng/L on presentation, with further testing indicated at 3 hours only in those     presenting early or with troponin concentrations between 5 ng/L and the 99th centile.      In six secondary and tertiary centres across Scotland, the investigators will introduce the     pathway as part of a stepped wedge cluster randomized controlled trial. Sequential hypothesis     testing will evaluate the efficacy and safety of the pathway. The primary efficacy end-point     will be length of stay from time of presentation until final hospital discharge and the     primary safety end-point will be survival free from type 1 or 4b myocardial infarction or     cardiac death from discharge to 30 days. The study population will consist of those patients     with cardiac troponin concentrations within the normal reference range (<99th centile) at     presentation.   "
21437|NCT03005145|"     The World Health Organization, U.S. Centers for Disease Control and Prevention, Association     of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all     declared antimicrobial resistance a global threat to health, based on rapidly increasing     resistance rates and declining new drug development. Up to 30-50% of antibiotic use is     inappropriate, and excessive durations of treatment are the greatest contributor to     inappropriate use. Shorter duration treatment (≤7 days) has been shown in meta-analyses to be     as effective as longer antibiotic treatment for a range of mild to moderate infections. A     landmark trial in critically ill patients with ventilator-associated pneumonia showed that     mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of     treatment. Similar randomized trial evidence is lacking for the treatment of patients with     bloodstream infection, which affects 15% of critically ill patients, and an estimated 50,000     Canadians per year.   "
21438|NCT03005132|"     Integrative analysis of GBM   "
21439|NCT03005119|"     A Phase II, double-blind, randomized, placebocontrolled, parallel-group study. Sixty (60) MS     patients will be enrolled. PTL201 doses will be titrated over a one-week period until     reaching MTD for each participant. The MTD will be administered for three weeks thereafter.     Participants demonstrating response to treatment will continue self administering daily     PTL201 treatment or placebo, for an additional four weeks. Participants will fill a daily     diary.   "
21440|NCT03005106|"     The proposed registration study is designed as a phase III open-label, controlled,     randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue     in promoting autologous skin tissue regeneration of complex skin defects due to thermal     burns. The proposed study will include patients with 3-49% total body surface area (TBSA)     complex skin defects due to thermal burns with intact dermal elements for which excision and     autografting are clinically indicated. The study has been designed to focus on the evaluation     of efficacy and safety of StrataGraft skin tissue, while also assessing the potential for     StrataGraft skin tissue to promote healing of complex skin defects due to thermal burns as an     alternative to donor site harvesting and autografting. Targeted enrollment for this study is     up to 70 subjects with complex skin defects caused by thermal burns that containing intact     dermal elements and for which surgical excision and autografts are clinically indicated.   "
21441|NCT03005093|"     The purpose of this study is to test the reliability and validity of the Turkish     Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing     disorders.   "
21442|NCT03005080|"     This study will use a 22 gene pharmacogenomics panel on 30 children with persistent     Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.   "
21443|NCT03005067|"     This study will be conducted in adult participants with symptoms of common cold assessing if     1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo.     The study will also evaluate the safety of 1146A compared to placebo.   "
21456|NCT03004898|"     CKD is a global endemic disease with increased comorbidities and mortality. The prevalence     and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The     prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk     factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education     deep into the community remains limited. The aims of this study are:        1. Explore risk factors associated with CKD in the community        2. Establish multidisciplinary care model in the community        3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in          behavioral , physiological, immune and metabolomics aspects        4. Provide bio-specimen repository for future study   "
21444|NCT03005054|"     The proposed study is designed as a phase II open-label, controlled, randomized, multicenter,     dose-escalation study of the safety, tolerability, and efficacy of a single or multiple     applications of StrataGraft skin tissue as an alternative to autografting in promoting the     healing of excised full-thickness complex skin defects resulting from acute traumatic skin     loss. The proposed study population will include patients with up to 49% Total Body Surface     Area (TBSA) complex skin defects including a full-thickness component. The study has been     designed to focus on the evaluation of safety and tolerability of prolonged exposure to     increasing amounts of a single or multiple applications of StrataGraft skin tissue, while     also assessing the potential for StrataGraft tissue to promote healing of the full-thickness     component of these complex skin defects as an alternative to donor site harvesting and     autografting. Targeted enrollment for this study is up to 20 subjects with complex skin     defects due to acute traumatic skin loss which require surgical excision and autografting.     Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving     StrataGraft skin tissue.   "
21445|NCT03005041|"     The purpose of this study is to investigate the consumer perception of an experimental     mouthwash formulation in population with dry mouth   "
24199|NCT02968914|"     An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable     drug exposure following Subcutaneous benralizumab administration by using accessorized     pre-filled syringe (APFS) or autoinjector (AI) devices.   "
21448|NCT03005002|"     This pilot clinical trial studies the side effects and how well durvalumab and tremelimumab     work in treating patients with microsatellite stable colorectal cancer that has spread to the     liver. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the     ability of tumor cells to grow and spread.   "
21449|NCT03004989|"     To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have     participated in return-to-work group programmes (RTW-GPs) and see how the programmes could     strengthen their work ability.   "
21450|NCT03004976|"     The primary objective of this study is to determine the efficacy of a single intravenous     infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in     patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB     or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or     myeloablative medications prior to the infusion. Subjects will be followed for one year post     infusion for safety and efficacy. Assessments will examine safety and tolerability of the     infusion, change in neurological symptoms, change in quality of life, and emotional and     cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and     365 days post infusion.   "
21451|NCT03004963|"     Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease     patients. Volume overload is a predictor of mortality in PD patients. In this Randomized     controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency     bioimpedance device, to measure the level of overhydration in PD patients and explore its     value in fluid management in peritoneal dialysis patients as well as their prognosis.   "
21452|NCT03004950|"     This study is an observational non-interventional study which will examine a) the accuracy of     biomarkers in predicting renal and cardiovascular outcomes after contrast-induced acute     kidney injury.      This study will obtain de-identified human plasma & urine samples and corresponding     de-identified research study data on subjects who are enrolled into the Prevention of Serious     Adverse Events Following Angiography (PRESERVE) study and Biomarker Collection and Analysis     in the PRESERVE Trial (VA CSP #578). Biomarker analyses will be performed on the     de-identified samples and merged with de-identified research study data.   "
21453|NCT03004937|"     Busy Primary Care providers (PCPs) have complex practices with many competing demands, making     it difficult to improve their HL identification rates. Little research has been conducted to     identify effective approaches to address the poor PCP knowledge and provide tools for them to     better identify/refer patients with HL for appropriate intervention. Current data suggests     there is a critical need to redesign how PCPs deliver hearing health care (HHC) by developing     focused educational programs and simple clinical management tools to help them integrate HHC     into their practices. To address this need, this study will educate providers on hearing loss     (HL) screening/treatment as well as create a Best Practice Alert (BPA), or clinical prompt,     that is configured for maximal effectiveness in reminding PCPs to ask their patients if they     think they have a HL. This combination of education for providers and clinical reminder could     help increase HL screening rates but how much is not clear. This 5 year R21/R33 study funded     by National Institute of Deafness and Communicative Disorders seeks to provide detailed     understanding of both how educating providers on HL and the use of an effective BPA affects     HL screening rates and identification for people with mild to moderate hearing loss.   "
21454|NCT03004924|"     The purpose of this study is to determine if an investigational treatment is effective     compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial     conjunctivitis.   "
21455|NCT03004911|"     The purpose of this study is to test the efficacy of a mobile application named ProFibro to     promote self-care, and improve symptoms and health-related quality of life in Brazilian     patients with fibromyalgia.   "
21465|NCT03004781|"     This research compared the efficacy of two parenting interventions that vary according to the     number and the nature of variables in reducing preschoolers' externalizing behavior (EB). The     goal was to identify which parenting intervention format (one-variable versus two-variable)     caused higher behavioral adjustment in children.   "
21466|NCT03004768|"     An oral dose in healthy subjects to obtain information about the absorption, metabolism, and     excretion (AME) of BMS-986165   "
21457|NCT03004885|"     Acute Respiratory Distress Syndrome (ARDS) still remains associated with a mortality rate of     30 - 45 % despite improvement in mechanical ventilation. Driving pressure, defined as the     difference between the end-inspiratory and the end-expiratory airway pressure, appears as an     important factor contributing to mortality in patients with the ARDS. In patients already     receiving a conventional tidal volume of 6 ml/kg predicted body weight (PBW), a driving     pressure ≥ 14 cmH2O increases the risk of death in the hospital. One mean to lower the     driving pressure is to decrease the tidal volume such that from 6 to 4 ml/kg predicted body     weight. However, this strategy promotes hypercarbia by reducing the alveolar ventilation,     providing the respiratory rate is constant. In this setting, implementing an extracorporeal     CO2 removal (ECCO2R) therapy may offset the associated hypercarbia. The investigators have     previously demonstrated that combining a membrane oxygenator within an hemofiltration circuit     provides efficacious low flow ECCO2R on a renal replacement therapy monitor. In this study,     we thought to investigate the efficacy of the PrismaLung stand-alone therapy. Using a     PrismaFlex monitor and a HP-X circuit, a neonatal membrane oxygenator (PrismaLung) is used to     provide decarboxylation without renal replacement therapy. The study will consist in three     periods:        -  The first period will address the efficacy of the PrismaLung device at tidal volume of 6          and 4 ml/kg PBW using an off-on-off design.        -  The second part of the study will investigate the effect of varying the sweep gas flow          and the mixture of the sweep gas on the CO2 removal rate (random order).        -  The third part will compare three ventilatory strategies applied in a cross-over design          :             1. Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure               (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA).             2. Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure               between 23 - 25 cmH2O.             3. Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table               (ARMA).      Each strategies will be apply in a random order for a duration of 22 hours. Pulmonary     inflammatory and fibrosis pathway will be assess before and after each period using     bronchoalveolar lavage (BAL) samples. Systemic inflammatory cytokines will also be     investigate. Main measurements will include respiratory mechanics, transpulmonary pressure,     work of breathing, end-expiratory lung volume and tidal ventilation using electrical     impedance tomography.   "
21458|NCT03004872|"     The purpose of this study is to evaluate potential risk factors for developing postpartum     depression or posttraumatic stress disorder during the first year postpartum in patients who     have no preexisting history of PTSD or PPD.   "
21471|NCT03004703|"     The main goal of this study is to evaluate the ability of a single administration of     tocilizumab to reduce myocardial damage in patients presenting with an acute ST-segment     elevation myocardial infarction (STEMI). Secondary objectives are to assess the impact of     treatment on: (i) final infarct size, (ii) left ventricular size and function, (iii)     inflammation, (iv) extracellular matrix remodeling, (v) lipid parameters, (vi) platelet     activation and additional pro- and anti-thrombotic parameters, and (vii) study drug safety     and tolerability.   "
21459|NCT03004859|"     Atrial fibrillation (AF) is the most common arrhythmia in Germany and is associated with an     increased risk of thromboembolic stroke. The risk to suffer from AF increases with age. Early     detection of AF and anticoagulation seem the most effective way of preventing ischaemic     stroke in patients at risk. The guidelines of the European Society of Cardiology recommend     opportunistic screening for AF by pulse check at each general practitioner visit for all     patients aged 65 years or older.      The objective of this study was to test whether an opportunistic AF screening with a     hand-held diagnostic tool in a German pharmacy setting is useful in detecting unknown AF     among people in the age of 65 and older. Besides a pulse palpation with a hand-held ECG-stick     the screening in the pharmacies also includes a questionnaire related to demographics and     medical history of the subject as well as several questions concerning the stroke risk     stratification (CHA₂DS₂-VASc). Every subject with a positive test result (indication on AF)     is insistently asked to make an appointment with his or her general practitioner. The subject     receives an information letter for his or her general practitioner that adverts to the     positive screening result and the necessity of further diagnostic Investigation.      In order to assess the incidence of unknown AF as well as accomplish the secondary objectives     of this study, two follow-ups by means of telephone interviews are performed. First, all     subjects with a positive test result are called 8 weeks after the screening in the pharmacies     was conducted. The subject is asked several questions concerning personal data/demographics,     the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea and stroke, the     bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the     Intervention and the mace. 12 months after the screening in the pharmacies was performed, all     participating subjects were called. The list of questions is similar to the one that is used     during the first telephone interviews after eight weeks.   "
21460|NCT03004846|"     GSK2981278 is an inverse agonist of retinoic acid receptor-related orphan receptor (ROR)     gamma. The aim of this study is to evaluate the safety, tolerability, clinical effect, and     systemic exposure potential of topically applied GSK2981278 ointment in subjects with plaque     psoriasis by treating all plaques on the body for 8 weeks. This single-center study will be     conducted in two parts. Part A will be an open-label, single arm study and part B will be a     double-blind, randomized, 2-arm, parallel-group, vehicle-controlled study. In Part A, 8 adult     subjects and in Part B, 18 adult subjects with chronic stable plaque psoriasis will be     enrolled. Total duration of study will be approximately 14 weeks. The results of this study     will provide preliminary information about safety and efficacy of the drug and will help in     providing the guidance for further development strategy.   "
21461|NCT03004833|"     The aim of the trial is to improve first-line treatment for early unfavorable cHL by     introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy     (AVD).      The primary objective is to show efficacy of the two experimental treatment strategies.     Secondary objectives are to further evaluate efficacy, show safety and feasibility and     perform correlative studies.   "
21462|NCT03004820|"     This is a single-arm, open-labeled and phase II futility study. Application of Remote     ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the     study. The study is to test whether RIC is effective in preventing ischemic evens after a     minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and     compliance of chronic RIC. Medication strategy is based on physician's best judgement.   "
21463|NCT03004807|"     Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons and     have an increased demand for many of these micronutrients. Multivitamin/multimineral     supplement offer a simple way for adults to improve nutrient intake, but their ability to     measurably affect micronutrient status in older adults has never been explored. This study     intends to recruit healthy, non-smoking men aged 70 years or older. After meeting entry     criteria, subjects will be required to restrict the use of supplements and/or fortified     foods. A month after these restrictions have begun, subjects will come to the clinical     research center to take cognitive tests, undergo activity monitoring, provide blood samples     for nutrition testing, and take food frequency questionnaires. Subjects will then be     randomized into one of two groups - one consuming a multivitamin/multimineral supplement     (Centrum Silver Mens Formula); another consuming an inert placebo tablet. Subjects will     consume 1 tablet each day for sixteen weeks. After this period, subjects will return to the     clinical research center and repeat cognitive tests, activity monitor, blood sampling, and     food frequency questionnaires. These data will be assessed to determine if multivitamin     consumption results in changes in various nutrients versus taking a placebo (primary     outcomes), and may results in changes lipid and lipoprotein profiles, metabolic health,     inflammation, blood pressure or cognitive function (secondary outcomes). The investigators     expect that results of this study will add to the gneeral understanding if     multivitamin/multimineral formulas can improve nutrition status of older adults, and     therefore have the capacity of altering markers of health.   "
21464|NCT03004794|"     Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be     obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision     of the McDonald criteria.      Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity     numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient     in different centers were counted only once.   "
21468|NCT03004742|"     This study will measure the effect of ingesting a flavonoid-rich supplement on various     biomarkers in overweight/obese women during a 12-week period. The flavonoid-rich supplement     contains a mixture of flavonoids including quercetin, catechins from green tea extract, and     anthocyanins from bilberry extract, and other food components that facilitate flavonoid     bioactivity including fish oil, caffeine, and vitamin C.   "
21469|NCT03004729|"     The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to     recognize cow's milk related symptoms in infants and young children.      Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's     milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers.      The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and     investigate if the CoMiSS tool could be an alternative to the open challenge test needed to     confirm the diagnosis of Cow Milk Protein Allergy.   "
21470|NCT03004716|"     The purpose of this study is to assess the feasibility and the reliability of a     telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive     pulmonary disease.      The feasibility is assessed using the patient's satisfaction and it ease of use.      The reliability of the remote telemonitoring system is assessed comparing the local data     (extracted from the monitoring device itself) and the data transmitted through the     telemonitoring platform.   "
21493|NCT03004417|"     Effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood, on pulmonary     function and on symptoms benefits in comparison with placebo.   "
25529|NCT02951520|"     This study aims to describe and to evaluate the effectiveness (success rate) of a supine     ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique     (SOFT block) in knee surgery.   "
21472|NCT03004690|"     Pandemics and re-emerging diseases put pressure on the health care system to prepare for     patient care and sample logistics requiring enhanced personnel protective equipment (PPE) for     health care workers. We generated quantifiable data on ergonomics of PPE applicable in a     health care setting by defining error rates and physically limiting factors due to     PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full     body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four     different tests (two laboratory tutorials, a timed test of selective attention and a test     investigating reaction time, mobility, speed and physical exercise) during 6 working hours at     22°C on one day and 4 working hours at 28°C on another day. Error rates and physical     parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related     parameters were assessed hourly using questionnaires. Depending on the PPE system the most     restrictive factors were: reduced dexterity due to multiple glove layers, impaired visibility     by flexible face shields and back pain related to the respirator of the fully ventilated     suit. Heat stress and liquid loss were perceived as restrictive at a working temperature of     28°C but not 22°C.   "
21473|NCT03004677|"     This study evaluates the effect of a late intervention of continuous skin-to-skin contact     (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the     intervention and the other half will receive standard care.   "
21474|NCT03004664|"     BACKGROUND AND SIGNIFICANCE:      Diabetes is a national health problem, yet Latinos from low-income households are at greater     risk. Although guidelines recommend that patients learn self-management strategies, many     people are not able to do so effectively and cannot control their diabetes. Studies show that     culturally competent self-management programming can help, but patients in preliminary     research indicated that not all programs sufficiently respect patients' cultural values or     account for their socio-economic limitations.      STUDY AIMS:      This project will compare two models for culturally competent diabetes self-management     programming. The hypothesis is that the program model that best considers patient culture and     accommodates patient socio-economic circumstances will have the best outcomes.      COMPARATORS:      2 diabetes self-management program models used by many Latino patients from low-income     households in Albuquerque, New Mexico        1. The Diabetes Self-Management Support Empowerment Model        2. The Chronic Care Model      STUDY POPULATION:      Patients will be 240 individuals who consider themselves to be Latino and who are from     low-income households. In addition, 240 patients will identify a corresponding social support     to participate with them. Outcomes will be measured based on the 240 patient participants.     Social support data will be measured as a covariate to understand patient outcomes.      PRIMARY OUTCOME:      Improved capacity for diabetes self-management measured as diabetes knowledge and patient     activation or the ability to put that knowledge into action.      SECONDARY OUTCOME:      Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient     stress levels will also be measured using testing of hair samples to identify levels of     cortisol as a biological marker for chronic stress.      METHODS:      Statistical calculations will be conducted to make sure that the things being compared are     differences in program design and not differences in individual patient characteristics. This     study will compare whether the programs improve diabetes health knowledge, ability to act,     and A1c, BMI, depression and stress control, and determine which program is the best.   "
21475|NCT03004651|"     Comparison of the level of agreement between Power Doppler ultrasound measured number of     synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen     joints in obese (i.e. BMI>30) versus normally weighted RA patients.   "
21476|NCT03004638|"     To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of     MEDI6012 in subjects with stable atherosclerosis.   "
21477|NCT03004625|"     A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein     (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice     daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.   "
21478|NCT03004612|"     Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face     this health problem. The goal of this clinical trial is to evaluate the effect of linagliptin     + metformin vs metformin alone on physiopathological parameters, such as glucose metabolism,     insulin resistance, insulin secretion and pancreatic beta cell function in patients with     impaired fasting glucose plus impaired glucose tolerance, during 12 months.   "
21479|NCT03004599|"     Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis   "
21480|NCT03004586|"     The goal of this clinical research study is to compare the effectiveness of a smaller,     25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle     aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.      The safety of the needles will also be studied.   "
21515|NCT03003962|"     This is a randomized, open-label, multi-center Phase III study to determine the efficacy and     safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of     advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic     lymphoma kinase (ALK) wild-type and with PD-L1-high expression   "
21481|NCT03004573|"     Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs     with a major impact on the quality of life. Social cognition is a complex system relying on     emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts:     emotional and cognitive), but also on the social and cultural environment and the personal     history. The first step in this model is represented by the NMS, which seems to be altered in     PD patients for both positive and negative emotions as shown in our preliminary study. The     investigator purpose is to investigate the role of the treatment (levodopa and deep brain     stimulation) on the functioning of the NMS.   "
21482|NCT03004560|"     The purpose of this study is to examine the psychological and psychosocial impact of surgical     scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo     bariatric procedures through the Duke Metabolic & Weight Loss Surgery program will be     enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic     surgery and 50 will be assigned to the percutaneous group. All patients will complete     pre-operative psychometric testing to establish a baseline body-image score as well as a     patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits     will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after     surgery. Subjects will complete the same psychometric measures to identify differences in     psychological and psychosocial responses to standard laparoscopic and percutaneous scars.     Patients will also complete a measure on scar satisfaction. The investigators hope to     identify any differences between standard laparoscopic versus percutaneous approaches.   "
21504|NCT03004274|"     The goal of this study is to assess whether running deep wound stiches will be superior to     deep interrupted stiches in body contouring surgeries in massive weight loss patients. This     is a split-wound study, thereby providing an internal control within each wound. Each side of     the wound will be randomized to receive one of the two suturing techniques. Patients and     raters will be blinded to the suture technique used in both wound-halfs.   "
21483|NCT03004547|"     Sodium (Na+) hemostasis is abnormal in CKD patients, and this element can be deposited in the     skin, muscle and skeleton - to cope with long term sodium loading. It is known that sodium     stored in this non-osmotically active way, is profoundly inflammatory. Furthermore,     inflammation has been associated with a number of uremic symptoms. The investigators will use     novel Na+ MRI imaging to examine the Na+ deposition in skin, muscle and skeleton of three     groups of patients: 1) chronic 3-times-a-week in-center hemodialysis patients, 2) peritoneal     dialysis patients, and 3) patients with CKD stage 4-5; and compare these results to age and     sex matched healthy controls. Additionally, they will investigate the association between     sodium deposition in these tissues with uremic symptomatology and biochemical markers of     metabolism.   "
21484|NCT03004534|"     The purpose of this study is to evaluate the effect of short-term treatment with ODM-201 on     breast cancer cells (i.e., how the treatment may change the genes or proteins in breast     cancer cells) and to evaluate its safety and the way it is tolerated by subjects.      The intent is to study these changes in order to have a better understanding of the potential     use of ODM-201 for women with EBC, know which patients are likely or unlikely to respond to     this treatment, and determine how ODM-201 may be combined with other anti-cancer drugs.   "
21485|NCT03004521|"     LQD is a multicentre randomised clinical trial comparing the clinical and cost effectiveness     of lithium versus quetiapine when used as add-on therapies to antidepressant medication for     patients with treatment resistant depression. The Lithium versus Quetiapine in Depression     (LQD) study will assess patients over 12 months to establish which (if any) treatment is more     likely to improve TRD over a long duration of time. Professor Anthony Cleare is the Chief     Investigator and recruitment is due to start in November 2016. Recruitment will begin in     London, followed by additional sites in Newcastle and Oxford in early 2017.   "
21486|NCT03004508|"     Primary objective: The primary objective of this study is to assess the effect of Ginkgo     biloba L. leaf extract (IDN 5933) in comparison to placebo in human subjects treated at     therapeutic doses for 6 months on the level of DNA damage and genomic instability, measured     with the Comet Assay and the Micronucleus assay, respectively .      Secondary objective:      The secondary objective of this study is to provide a preliminary assessment of the safety of     Ginkgo biloba L. leaf extract (IDN 5933) in human subjects treated at therapeutic doses in     term of adverse drug reaction, hepatotoxicity, genotoxicity.   "
21487|NCT03004495|"     To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of     CHF6001 and CHF5259, in comparison with the single components, administered in healthy     subjects via a multi-dose reservoir NEXThaler® DPI.   "
21488|NCT03004482|"     Video recording for term and preterm newborns hosted at the AUBMC Neonate ICU will be     collected. The videos will capture movements, skin color changes, positioning, and other     features relevant to the diagnosis in question. Recorded video images will be analysed by a     computer software using the Eulerian Video magnification technology; then images will be     correlated with simultaneously recorded physiological parameters (heart rate, respiratory     rate and saturation). Images will be annotated by the clinician. Correlation between the skin     coloration differentials and annotated physiological parameters may establish physiological     indices. These may be used to extrapolate the existence or absence of disease states.   "
21489|NCT03004469|"     The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in     patients with androgenetic alopecia.   "
21490|NCT03004456|"     Children with chronic diseases, particularly those who have received transplantation (e.g.     cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as     venipuncture multiple times per week. There is currently no standard of care for pain     reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an     outpatient. The study aims to determine the efficacy of distraction in reducing procedural     pain and distress associated with venipuncture in pediatric post-transplant patients.   "
21516|NCT03003949|"     Women in the menopause transition ('perimenopause') are exposed to extreme hormone     variability, tend to experience a unique set of severe stressors (e.g., divorce, death of     loved ones), and are also at substantially elevated risk to suffer from mood and anxiety     disorders. The purpose of this research is to understand the mechanisms by which variability     in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest     and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal     manipulation, this research will determine the degree to which the E2 variability (or E2     levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it     does so by affecting biological responses to stress.   "
27870|NCT02920931|"     A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and     Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir     Disoproxil Fumarate) in Healthy Male Volunteers.   "
21491|NCT03004443|"     Increased inflammation has been implicated in the pathophysiology of a number of     neuropsychiatric illnesses including mood disorders, which affect almost 30 million adults in     the United States alone. One mechanism by which inflammation may alter behavior is through     increasing brain glutamate, a neurotransmitter that in excess has been implicated in neuronal     toxicity and resistance to conventional antidepressant therapy. The goal of the proposed     research is to test the hypothesis that inflammation alters behavior through increasing     glutamate in specific brain regions, ultimately leading to behavioral changes.      The proposed research is designed to determine the cause and effect relationship between     inflammation and CNS glutamate as well as the relationship between CNS glutamate and specific     symptoms. To accomplish these aims, investigators will administer a single infusion of either     the tumor necrosis factor (TNF) antagonist infliximab or placebo (n=30 per group) to patients     with high inflammation (CRP>3mg/L). A CRP>3mg/L was chosen because it is considered high     inflammation according to guidelines by the American Heart Association. Moreover, a CRP>3mg/L     is associated with significantly increased basal ganglia glutamate and with a clinical     response to infliximab. Inflammatory biomarkers, basal ganglia glutamate as measured by MRS,     and motivation and psychomotor activity will be assessed at baseline and days 1 and 3 and     weeks 1 and 2 following infliximab or placebo administration.   "
21492|NCT03004430|"     To evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive     therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to     increased spirituality as a potential mediating factor of positive mental health.   "
21494|NCT03004404|"     The primary objective of the SRD part (trial part 1) is to investigate the safety and     tolerability of BI 730357 in healthy subjects following oral administration of single rising     doses after fasting and/or non-fasting conditions. The secondary objective is the exploration     of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI     730357 after single dosing.      The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative     bioavailability of tablet fasted versus oral solution fasted and the influence of food on the     bioavailability of tablet fasted versus tablet fed.   "
21495|NCT03004391|"     In 2015 the Danish Health authorities initiated major changes in the national follow-up (FU)     program for ovarian cancer patients. The new FU program argues that there is no effect of     routine monitoring of tumour marker CA125. Now every patient needs to choose if they wish     routine measurement of CA 125 to be part of the follow-up program.      Shared Decision Making (SDM) can help health professionals develop a more individualized care     plan in collaboration with the patient, as stated in the revised national FU program. Due to     the complexity and challenges within ovarian cancer care, this is an evident area of focus.      SDM is defined as an approach in which the clinician and patient go through all phases of the     decision-making process together and share the preference for treatment and reach an     agreement on treatment choice. Clinicians have information about disease, tests and     treatments, whereas patients hold information about their life circumstances, goals of life,     and preferences for healthcare. SDM thereby offers a way of individualizing recommendations,     according to patients' special needs and preferences. SDM has potential to give the patients     a higher quality of healthcare by putting the patient in the center of care.      Decision aids (DA) are tools that can provide information and systematically describe the     advantages and disadvantages of a specific intervention or monitoring, which can help     patients become involved in decision making. Using evidence-based DA leads to improvement in     knowledge, better understanding of screening, prevention and treatment options, and more     accurate perception of risks for the patients.      All participants fill in a demographic and Decisional Conflict Scale questionnaire at     baseline. After having been presented with the decision aid and made a choice as to CA125,     the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire     dealing with confidence as to the choice made and the level of shared decision making     experienced. Six months later the Decision Regret Scale questionnaire is to be completed to     reveal any regrets in relation to the CA125 decision.      For a preliminary investigation of the applicability of the DA, 15-20 patients not eligible     for this study will be asked for their opinion.   "
21496|NCT03004378|"     This study will be the first to evaluate whether the short- and long-term use of activity     tracking devices improve short- and long-term weight loss in adolescents. The investigators     will be the first to establish whether weight loss translates into a change in     obesity-related biomarkers associated with adolescent obesity. In addition, the investigators     will be the first to report outcomes after the implementation of activity tracking devices in     conjunction with an intense adolescent weight loss program.   "
21497|NCT03004365|"     The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in     multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.   "
21498|NCT03004352|"     The aim of the study is to determine if increased retrograde shear would further deteriorate     the already impaired vascular function in severe COPD patients.   "
21499|NCT03004339|"     Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment     in topical formulations   "
21500|NCT03004326|"     Multi-center observational study to evaluate the histopathology and transcriptome of     cutaneous lesions in patients with several different types of vasculitis.   "
21501|NCT03004313|"     The main purpose of this study is to integrate novel MRI techniques with positron emission     tomography(PET) for the study of structural and molecular neuroplasticity in the brain of     migraineurs, and its clinical association with changes in pain perception and modulation     (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future,     assist doctors in better understanding how pain is felt and regulated in migraine sufferers.   "
21517|NCT03003936|"     The purpose of this investigation is to assess in a community-based cohort of late-night     eaters the effect of coincident food intake and endogenous melatonin on glycemic control, and     the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on this     relationship. With the results from this study, the investigators expect to advance in the     understanding of the role of endogenous melatonin on glucose metabolism in late night eaters     and carriers of the MTNR1B risk allele, with potential implications on the guidelines to     mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.   "
21518|NCT03003923|"     The aim of this cluster randomised control trial is to test the efficacy of a repeated taste     exposure intervention, a nutritional educational intervention and combination of both to     increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).   "
21519|NCT03003910|"     This study is aimed to test the efficacy of a positive psychological intervention for     promoting positive emotions and optimistic thinking in eating disordered patients.     Participants are randomly assigned to receive the positive intervention or the control     condition, which consists on thinking about daily activities.   "
21502|NCT03004300|"     The most frequent causes of mouth breathers are the adenotonsillar hypertrophy.     Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this     surgical treatment does not have its effect well elucidated and apnea has been cited in the     literature as a residual outcome. Other types of supporting treatment may also been involved     such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among     them rapid maxillary expansion (RME).      RME corrects the morphological constriction of the upper arch caused by buccal breathing and     also reduce the airway resistance. Despite reports of RME influencing volume enhancement in     pharyngeal airway, there are still few three-dimensional studies following the post-expansion     effects. In addition, these changes are doubtful due postural changes of the tongue during     the tomography exam. Conflicts of results are also present for changes in the nasal septum of     children. The main alteration mentioned is the increase in the length of the lower third of     the septum.      The investigators propose a randomized, prospective, controlled clinical trial in patients     with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be treated     with RME and adenotonsillectomy when the obstruction is present. The purpose of this study is     elucidate if there is different outcomes considering the moment of RME treatment before or     after the adenotonsillectomy.   "
21503|NCT03004287|"     This study will assess whether adding one of the newest multiple myeloma therapies,     daratumumab, into the Total Therapy approach helps patients live longer with fewer side     effects   "
21533|NCT03003715|"     The main goal of this study to integrate techniques producing images of the brain (also     called neuroimaging techniques) with non-invasive brain stimulation to investigate factors     that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).   "
21505|NCT03004261|"     Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for     recipients of allogeneic hematopoietic stem cell transplantation(HSCT). we propose to study     the immunologic and virologic effects of donor derived CMV specific cytotoxic T lymphocyte     (CMV-CTL) given to transplant recipients      CMV antigen peptides will be used to induce the CMV antigen specific T lymphocytes derived     from donor peripheral blood mononuclear cells for a period of 18~21 days.The patients will     receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The     CMV-DNA level will be monitored weekly after transfusion.   "
21506|NCT03004248|"     This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of     moderate to severe glabellar lines following single and repeat administration.   "
21507|NCT03004066|"     10 patients with chronic heart failure receiving daptomycin therapy after implantation of a     left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids     (mediastinal and pleural drainage systems) and in blood samples.   "
21508|NCT03004053|"     The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur     inside the mouth, using a special camera. These pictures will be used in our research to     evaluate a new technology that uses a laser and takes pictures of the microscopic structure     of tissue. The technology is called reflectance confocal microscopy.   "
21509|NCT03004040|"     The investigators propose a unique methodology of studying infection and vaccination history     and immune responses. As most studies in infection history are conducted on mice, limitations     are inherent on their applicability to humans. A longitudinal comparison study following     older adults (over the age of 65) hospitalized for influenza are followed through to their     hospital discharge and vaccination in the following season. This will allow for the     investigation of the course of infection, as well as impact on the response to vaccination.   "
21510|NCT03004027|"     Individuals with visible conditions often report experiencing lowered social confidence and     encountering intrusive reactions from others, yet relatively few targeted psychosocial self     help interventions are available.      The investigators will conduct a randomised controlled trial to compare the efficacy of an     adapted form of an existing self-help intervention with an enhanced version of the same     intervention that incorporates if-then planning instructions (or 'implementation intentions')     and a control condition that will receive support as usual. Participants who self-identify as     having a visible condition affecting the skin or hair, or scarring to the skin that     negatively affects their social confidence will be allocated to one of three conditions:     augmented self-help, standard self help or control. The interventions will be delivered     online and participants will complete psychometric outcome measures at two time points, four     weeks apart.      It is hypothesised that participants who receive the augmented self help intervention will     have a statistically significant decrease in fear of negative evaluation in comparison to     both the standard self-help and support as usual control groups.   "
21511|NCT03004014|"     Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the     site and configuration of upper airway obstruction in patients with obstructive sleep apnea     (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep.     Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical     treatment.      Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be     enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the     night. Propofol induced sleep will be performed at the operating room before surgery. The     VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be     used to compare site and configuration of collapse between studies. Peak inspiratory flow     will also be compared between studies.   "
21512|NCT03004001|"     The study purpose is to determine the hypolipidemic effect of Alirocumab co-administered with     atorvastatin on levels of triglyceride-rich lipoproteins and LDL compared to monotherapy with     atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.   "
21513|NCT03003988|"     This study was designed to examine how different forms of creatine impact active males.   "
21514|NCT03003975|"     This is a clinical study where the investigators will assess the efficacy of a single     cryoballoon application per vein guided by a multipolar recording catheter as compared with a     conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in     patients with atrial fibrillation (AF).   "
21520|NCT03003897|"     Dietary fiber intake is protective against overweight and obesity; however, a significant     fiber gap exists between consumption and recommended intake values. Soluble fiber     beneficially impacts metabolism, and supplementation may be a feasible approach to improve     body composition and glycemia in overweight and obese individuals. The investigators will     evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation     among overweight and obese adults for outcomes related to weight management (e.g. body mass     index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin     homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance     [HOMA-IR], fasting insulin) through systematic review and meta-analysis.   "
21521|NCT03003884|"     The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a     procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and     safety profile comparing to propofol.   "
21544|NCT03003572|"     Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to     life-threatening conditions and is always responsible for a decreased quality of life. Its     evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be     carried out routinely is major in patients' follow-up. Because of the existence of     autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for     anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific     pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to     determine pSS's activity. The aim of the study is to evaluate whether the proportion of     anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular     Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or     already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the     disease's features will be collected (including Eular Sjögren Syndrome Disease Activity     Index/Eular Sjogren's Syndrome Patient Reported Index).   "
21522|NCT03003871|"     Stroke is the second most common cause of death worldwide and is the predominant cause of     permanent disability among older people. The mouth becomes a very unhealthy place after     stroke, where yeasts and pathogenic bacteria multiply at an accelerated rate. Poor oral     hygiene results in increased dental plaque, gingival bleeding, and the harbouring of oral     opportunistic pathogens. Dental plaque acts as a reservoir of pathogenic microorganisms which     results in additional oral health problems and also can cause life-threatening medical     complications; most notably aspiration pneumonia and/or recurrent stroke. The first six     months following stroke is a particular vulnerable period to survive.      Removal of dental plaque and its associated pathogenic microorganisms is challenging in this     compromised state of reduced manual dexterity and weak state following a stroke. Powered     (electric) toothbrushes can be of assistance in plaque removal in frail elders. For more     resistant oral pathogens, anti-plaque/anti-microbial mouthrinses can offer additional help in     controlling dental plaque and thereby prevent harbouring potentially life threatening oral     pathogens. Over the years the Faculty of Dentistry and the Stroke Rehabilitation Unit of the     Department of Medicine in Hong Kong have been actively working together to address the     problems of oral health associated with stroke; and specifically the challenge of     safeguarding the life and health of stroke survivors during the vulnerable rehabilitation     period. We are now proposing to involve stroke patients during out-patient rehabilitation in     a randomized clinical trial to test the effectiveness of powered tooth brushing and a     chlorhexidine anti-microbial mouthrinse in reducing dental plaque accumulation and oral     pathogens; and how this affects their general and oral health status. We anticipate that all     participants will benefit from the oral health promotion initiatives and that the advantages     will be long lasting. We expect to demonstrate a 'gold standard' of oral health preventive     care, as part of stroke rehabilitation, that can reduce (or has potential to reduce) serious     medical complications after a stroke. If proven effective this oral health preventive care     regime (which is relatively easy to implement and at low cost) could widely be adopted in     stroke rehabilitation globally.   "
21523|NCT03003858|"     The purpose of this observational, non-controlled, single site trial with a retrospective     design is to verify, in a large paediatric population affected by gingivitis, the     tolerability and safety of 0.1% HA-based film-forming devices (Gengigel Prof® Fluid,     Ricerfarma) administered three to five times a day over a 4-week period as an adjunct to     domiciliary care and oral hygiene instructions   "
21524|NCT03003845|"     For each patient in the study, blood, and pain scores will be collected to look for markers     for pain, at the start of treatment and 6 months after surgery of treatment.   "
21526|NCT03003819|"     A prospective RCT of intact extractions with delayed implant placement comparing extraction     socket management effectiveness and office economics of two collagen matrices. Soft tissue     wound healing will be assessed out to 4-months post-operative, when implants will be placed.   "
21527|NCT03003806|"     The DreaMed Advice4U Pro is a software which automatically analyses treatment information,     learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed     Advice4U Pro uses information gathered from glucose monitoring (sensor readings or capillary     blood glucose measurements), insulin dosing and meal data during daily routine home care.     Following a 5-minute data collection and analysis, the algorithm learns and suggests     pump-setting changes for optimization of glucose control      The algorithm is designed as an advisory tool and has three main components:        1. A statistical analysis of the insulin pump and sensor data: insulin delivery,          bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia          patterns.        2. Practical recommendations, alert messages based on aforementioned data        3. Recommendation for new insulin pump settings: including basal intervals and rate,          different carbohydrate ratio according to time of day, correction factor and insulin          sensitivity time.      The main goal of the DreaMed Advice4U Pro is to improve diabetes management for subjects with     Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump     users.      The main objective of the proposed study is to evaluate the safety and efficacy of using the     DreaMed Advice4U Pro algorithm versus medical guided recommendation to determine insulin     dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.   "
21528|NCT03003793|"     The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many     years. Novel research shows an association between the two conditions. While this     relationship at least in theory can be explained by lifestyle factors, there is reason to     believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that     patients with atopic dermatitis are insulin resistant due to their chronic inflammatory     state. Insulin resistance might play an unknown part in the increased frequency of type 2     diabetes among patients with atopic dermatitis. In the present project, the investigators aim     to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic     euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control     group (matched case-control study). The project is a close collaboration between The     Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.   "
21529|NCT03003780|"     This is a developmental project with two phases. The first phase will adapt an existing     web-based intervention to incorporate mind-body exercises to develop a multi-modal     intervention to promote physical activity in patients with COPD and HF. The second phase will     pilot test this new intervention in a longitudinal study (subjects randomized to intervention     or usual care).   "
21530|NCT03003754|"     Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide     interindividual variability after exercise training explored mainly in adults but not in     children. Thus, is yet unknown what baseline health status as well as the influence of what     health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of     subjects who experienced a non-change/worsened response after training in some metabolic     outcomes) after exercise training in school children.   "
21531|NCT03003741|"     There is a new form of bupivacaine, called Exparel, which can be injected into the eye socket     during surgery and may provide pain relief for up to 72 hours. The purpose of the study is to     compare the plain bupivacaine injection to Exparel, to see if one medication works better     than the other.   "
21532|NCT03003728|"     This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple     myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell     transplant. Natural killer cells are a special type of white blood cells that are already     present in the body which have the ability to kill myeloma cells. In this study, natural     killer cells will be collected and then treated in a laboratory to activate and 'expand' the     number of cells to increase the dose and the anti-myeloma activity of the cells before they     are transfused back into the subject. Elotuzumab is a protein drug approved by the United     States Food and Drug Administration (FDA) for patients with previously treated multiple     myeloma and works by activating natural killer cells already present in the body and     targeting a protein called SLAMF7 which is present on both natural killer cells and myeloma     cells. The investigators hope that administering Elotuzumab in combination with ENK cells     will enhance the anti-myeloma activity of the ENK cells.   "
21534|NCT03003702|"     Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs     that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in     activities, patients are prone to developing chest infections called 'exacerbations'.     Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to     cause hospital admission (and therefore health facilities pressures) and death. Reducing the     impact of exacerbations is very important. We have previously shown that earlier treatment of     COPD exacerbations results in faster recovery, and reduced chance of hospital admission.     Helping patients to detect exacerbations early is therefore important. We have also recently     shown that monitoring heart rate and oxygen saturation via a finger probe may assist in this.     However, measuring these variables when the patient is awake means they can be affected by     other things, such as exercise and anxiety. Our new idea is that measuring heart rate and     oxygen level overnight, when a patient is asleep, will give the best chance of detecting COPD     exacerbations early and our study will test that. We will randomly allocate 64 patients with     COPD recruited from our service in London to standard monitoring, or overnight monitoring,     for up to six months or the first exacerbation, whichever is sooner. We will then analyse     whether overnight monitoring was able to detect exacerbations earlier, and therefore could be     used to help patients get treatment earlier. A subset of participants will also wear an     activity monitor overnight for the first two weeks, so that we can assess the effect (if any)     of overnight awake periods (such as trips to the bathroom) on the heart rate and saturation     recording.   "
21535|NCT03003689|"     Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal     (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque     is critical for improving the periodontal health. The standard initial treatment of     periodontitis (gum disease) is to remove plaque and calculus form the teeth and root     structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic     scaler are used for SRP      While this method removes some of the bacteria that leads to periodontitis, microorganisms     are not completely eliminated through SRP. Studies have shown that after 3 months, the     bacteria initially present prior to scaling and root planing had recolonized. In order to     prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low     levels.      When used at the proper wave length, dental lasers have been shown to effectively removes     calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the     use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown     that it is effective in removing calculus and preserving the tooth root structure, there is     no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in     removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.      The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct     to scaling and root planing, in removing microbial bacteria. Participants with chronic     periodontitis will be randomized to have one quadrant undergo scaling and root planing using     hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same     treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional     periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures     will be performed at baseline and 3 months to compare survival and re-population by     periodontal microorganisms.   "
21536|NCT03003676|"     This is a single center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in     patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary     objective of the study is to determine the safety of sequential treatment with ONCOS-102     followed by pembrolizumab. The protocol aims to enroll 6 patients into each of two cohorts:     prior PD1 monotherapy or prior combination PD1 plus ipilimumab combination therapy.   "
21537|NCT03003663|"     The purpose of this study is to determine the effect of an Internet-of-Things bed fall     solution when used in a hospital setting.   "
21538|NCT03003650|"     First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in     Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the     safety and performance of the device.   "
21539|NCT03003637|"     This is a phase IB/II trial to examine feasibility and safety of checkpoint blockade (aPD1     with or without aCTLA4) neoadjuvant to standard of care (SOC) in advanced stage head and neck     squamous cell carcinoma (HNSCC), a patient population in need for improved clinical outcome     and in tumors likely to respond to neoadjuvant aPD1 and aCTLA4. In addition, with this     research protocol the potential impact of intratumoral hypoxia on tumor infiltrating     lymphocyte (TIL) abundance, differentiation and effector function will be assessed, and the     potentially divergent effects of T cell checkpoint blockade in areas of hypoxia and normoxia.   "
21540|NCT03003624|"     The aim of the present study was to compare the outcomes of incisions made by Colorado®     microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.   "
21889|NCT02999087|"     The purpose of this study is to demonstrate that treatment with avelumab in combination with     RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab     alone in terms of progression-free survival (PFS) in front-line patients with locally     advanced SCCHN.   "
21541|NCT03003611|"     The investigators will compare the operated patients for a beginning breast cancer in the     Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational     study as we cannot randomized patient, (they need to be compliant with Hypnose).      Patient will be informed that some parameters, about his recovery, will be collected from     their medical file. They will not have another particular treatment because they are in the     study. It is just a prospective data collection.      The patient will be compared on several items after the surgery ( as pain and pain killer     intake, the heal process of the scar, etc...) Also the investigators will compare the impact     of hypnose on the other treatments the patient received.      The investigators need approximately 150 patients (Half in each arm).   "
21542|NCT03003598|"     In this study, the investigators aimed to compare the effects of endotracheal intubation via     direct laryngoscope (DLS) and McGrath Videolaryngoscope (VL) on intraocular pressure.   "
21543|NCT03003585|"     In this study, the investigators aimed to compare the effects of direct laryngoscopic and     fiberoptic endotracheal intubation on intraocular pressure.   "
21545|NCT03003559|"     For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive     pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild     AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we     design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal     cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild     AECOPD.   "
21603|NCT03002805|"     This study evaluates the combination of CBT-1® and doxorubicin for the treatment of     metastatic, unresectable sarcoma in patients who have progressed after treatment with     150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day     cycle, as well as doxorubicin on days 5 and 6.   "
21604|NCT03002792|"     The purpose of this study is to investigate whether early expose to general anaesthesia will     influence neurodevelopment.   "
21546|NCT03003546|"     This phase I trial studies the best dose and side effects of paclitaxel albumin-stabilized     nanoparticle formulation (nab-paclitaxel)/rituximab-coated nanoparticle AR160 in treating     patients with B-cell non-Hodgkin lymphoma that has come back or is not responding to     treatment. Nab-paclitaxel/rituximab-coated nanoparticle AR160 is a combination of paclitaxel     albumin-stabilized nanoparticle formulation and rituximab. Drugs used in chemotherapy, such     as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with     the ability of tumor cells to grow and spread. Giving paclitaxel albumin-stabilized     nanoparticle formulation and rituximab may work better in treating patients with B-cell     non-Hodgkin lymphoma.   "
21547|NCT03003533|"     This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the     safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals     with hemophilia A.   "
21548|NCT03003520|"     This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical     activity, predictive biomarkers and pharmacokinetics/ pharmacodynamics of durvalumab in     combination with R-CHOP (Arm A) or R2-CHOP (Arm B), followed by durvalumab consolidation     therapy in previously untreated subjects with high-risk DLBCL.      Patients with non-ABC subtype (determined by gene expression profiling) will be allocated to     Arm A while patients with ABC (activated B-cell type) subtype will be allocated to Arm B.     Approximately 120 patients may be enrolled and assigned into the appropriate treatment arms     dependent upon their cell of origin status.      Induction treatment with R-CHOP (± Lenalidomide) will last for a total of up to 6 to 8     treatment cycles (21 days cycle), and the total time on study treatment, including durvalumab     consolidation, will last up to 12 months.   "
21549|NCT03003507|"     Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these     patients receive enteral feeding. There is controversy about ideal carbohydrate composition     of these diets. The aim of this study was to compare an enteral formula with the same     proportion of carbohydrates with and without fructose on blood glucose levels.   "
21550|NCT03003494|"     The purpose of the study is to measure changes in physical functioning in chronic obstructive     pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6     weeks in routine clinical practice.   "
21551|NCT03003481|"     Collect patient data and to monitor the clinical use (safety and efficacy) of the device   "
21552|NCT03003468|"     This is an open label, multi-institutional, single arm study with a dose escalation phase Ib     cohort, followed by a phase II cohort of pembrolizumab and Imprime PGG. No randomization or     blinding is involved.   "
21553|NCT03003455|"     The purpose of this study is to determine whether nasal intubation over a bougie placed via a     nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind     nasal endotracheal tube passage.   "
21554|NCT03003442|"     Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective ratings     of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a consequence     of exercise and metabolically demanding cognitive tasks.   "
21631|NCT03002441|"     The purpose of this randomized trial is to compare same-day cervical preparation using     Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before     D&E at 16.0 to 20.0 weeks.      Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™     plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative     time.      Secondary objectives: To compare treatment groups for the following: Pre-operative cervical     dilation; need for mechanical dilation and ease of dilation if required; ability to complete     D&E without further cervical preparation; ease of D&E; complications; pain; side effects;     patient and provider satisfaction.   "
21555|NCT03003429|"     The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the     model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the     parasympathetic nervous system and a decrease of the sympathetic system. Various explanations     of this these dysfunctions are proposed in literature, mainly malnutrition, physical     hyperactivity, anxiety, that are known characteristics of anorexia nervosa.      The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety     in anorexia nervosa.      Other objectives of this study are firstly to evaluate correlation between ANS dysfunction     and others parameters (weight, body mass index, depression, physical activity, purgative ou     restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if     HRV is a predictive parameter of the evolution of anorexia nervosa.   "
21556|NCT03003416|"     This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in     France for the treatment of Diabetic Macular Edema (DME).   "
21557|NCT03003403|"     Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical     practice guidelines clearly recommend that these patients avoid gaining weight. However,     despite this clinical guideline, weight gain prevention interventions are not available in     primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for     weight gain prevention for patients within rural community health centers, using a digital     health platform.   "
21558|NCT03003390|"     The purpose of this phase 2a, multi-center, single arm study, is to explore the efficacy of     early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically     ill children.   "
21559|NCT03003377|"     The study was designed to determine and compare the sevoflurane EC50 optimal concentration     for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during     target-controlled infusion of remifentanil.   "
21560|NCT03003364|"     This is a phase I/IIa, randomized, double-blind, single-dose, placebo controlled, two-way     crossover clinical trial in which 10 patients from 18 to 65 years of age affected with     chronic traumatic spinal cord will enter the study with the objective to assess the safety     and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly     mesenchymal stem cells.   "
21583|NCT03003065|"     In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents     in patients with inoperable bile duct cancers. In addition as a preliminary study we sought     to determine if the treatment can reduce tumor volume in the short term.   "
21561|NCT03003351|"     This is a pro- and retrospective cohort study to evaluate the natural history and outcome of     various treatment options of patients with fistula. At each clinical visit parameters     describing activity of a fistula, potential underlying Crohn's disease, investigations as     well as the current treatment will be entered into a database. Selected patients can also be     contacted by phone in the form of a structured interview. Data will be analyzed to determine     treatment outcomes, characterize the natural history as well as risk factors for     complications of treatment and an unfavorable disease course. The same data will be obtained     and analyzed retrospectively from patients who visited the clinic prior to January 2017.   "
21562|NCT03003338|"     This is a 1:1 randomized double-blind Placebo-controlled moncenter Phase IV study to     investigate whether a successful interferon-free treatment of HCV-infection with     ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves     the patients' attention ability as compared to placebo as measured with the Att Test Sum     Score change from baseline to week 12. A total of 30 patients with non-cirrhotic genotype 1b     HCV infection will be randomly assigned to receive 12 weeks verum followed by 12 weeks     Placebo (arm A) versus 12 weeks Placebo followed by 12 weeks verum (arm B). Patients will be     followed up for 48 weeks.   "
21563|NCT03003325|"     The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the     addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy     available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the     efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years     and without prior vascular events), in term of control of recommended level of hematocrit <     45%, over a period of 12 months.   "
21564|NCT03003312|"     Objective:The aim of this study is to investigate the prevalence and associated factors of     pediatric urolithiasis in Kashgar area in China.      Methods: The investigators carry out a cross-sectional survey among children aged 0 to14     years across Kashgar area in China. The participants are selected by a two-stage and     clustered random sampling method. Participants are asked to undergo urinary tract     ultrasonographic examinations, provided blood and urine samples to analyze. Their parents or     guardians are asked to fill out the questionnaires. Children those who are found with any     abnormalities of their urinary system by ulrtasonography will undergo a low-dose computed     tomography (CT) to confirm the abnormalities. The end point of this study is to calculate the     prevalence rate, distribution and associated factors of pediatric urolithiasis in Kashi area.   "
21565|NCT03003299|"     To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,     California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.   "
21566|NCT03003286|"     The purpose of this study is to determine whether a new treatment, Unstuck and On Target     (UOT), works better, worse, or the same as the best treatment that is available now,     Contingency Behavioral Management (CBM), for low income children with Autism Spectrum     Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Researchers predict that     UOT will be better than CBM for children with ASD and ADHD at improving cognitive problem     solving, executive functioning, self-control and use of medical care, but equal to CBM at     improving behavior and coping.   "
21567|NCT03003273|"     Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low     risk features (culture awaited), will be started on intravenous antibiotics (Inj     Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed     for randomization once they fulfill all inclusion criteria and get afebrile for at least 24     hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous     antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or     reappearance of fever within follow-up of ≤ 10 days.   "
21568|NCT03003260|"     Rationale: IBS is the most common functional gastrointestinal disorder with a prevalence     worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain and altered     bowel habits. Although the condition is not life-threatening, it strongly impairs quality of     life and up to now there is no cure for IBS. It is assumed that IBS symptoms are related to a     combination of altered gut motility and secretion, and visceral hypersensitivity. However,     its primary cause still remains largely unknown. The endocannabinoid system, together with     some functionally related receptors is among the biological targets considered promising for     treatment. Modulation of the CB1 , CB2 and related receptors or enzymes of the     endocannabinoid system in a broader sense by (endo) cannabinoids or (and) structurally     related lipid mediators can influence motility, secretions and decrease hypersensitivity in     the gut. Among the plant-derived cannabinoids or so called 'phytocannabinoids', cannabidiol     (CBD) is of special interest as it has shown therapeutic potential in preclinical studies and     a growing number of case-reports. CBD is a non-specific phytocannabinoid displaying a broad     but weak receptor interaction profile. In contrast to the well-known THC from Cannabis     sativa, CBD is not psychoactive and often also present in those Cannabis varieties that are     not used for their psychoactive properties but for industrial (fibre) or food properties     (oil, flour and seeds) instead. Based on preclinical studies and in vitro data we hypothesize     that CBD might be able to relieve symptoms of IBS, including pain in patients with IBS. The     chewing gum is to be taken 'on demand' and may have some additional perceived positive     effects.      Objective: To investigate whether the use of a CBD-containing preparation in the form of     CanChew® chewing gum can contribute to a reduction of IBS symptoms and an improvement of     perceived wellbeing in patients with IBS.      Study design: A randomized, double-blind, cross-over trial of 8 weeks in total.      Study population: Adults, aged 18-65, diagnosed according to the ROME III criteria with     Irritable Bowel Syndrome.      Intervention (if applicable): Patients will, in this cross-over study, receive a maximum 6     chewing gums per day, either containing 50 mg of cannabidiol per chewing gum in case of the     CanChew chewing gum, or a placebo chewing gum. This first intervention period will last 3     weeks. Next, participants will undergo a one week wash-out and then switch intervention to     either placebo or the CanChew chewing gum for another 3 weeks.      Main study parameters/endpoints: The main study parameter is a change in pain reduction     perception experienced and measured by the patient using VAS-scales before and after taking     the chewing gum, to be recorded in a diary. Next to this a patient is asked to provide one     VAS score for each completed week. Furthermore, the adequate relief will be measured every     day. At the end of each week patients will also be asked (from their diary) whether they     noticed a change in stool frequency or (and) experienced any side-effects. For the     disease-related quality of life the IBS-QOL will be used. This questionnaire will be filled     out in week 1, 4, 5, and 8.   "
21569|NCT03003247|"     Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris   "
21632|NCT03002428|"     The purpose of this study is to compare the effects of two teriparatide products, PF708 and     Forteo, in patients with osteoporosis.   "
21570|NCT03003234|"     Functional dyspepsia (FD) is an extremely common disorder of gastrointestinal function.     Recently, impaired duodenal mucosal integrity was reported as a potential pathophysiological     mechanism in FD. However, the factors controlling duodenal mucosal integrity remain unknown.     In this study, we evaluated whether the luminal bile salt content could play a role in     impaired duodenal permeability in FD.      Duodenal biopsies were obtained from 25 healthy volunteers (HV) and 25 FD patients. Biopsies     were mounted in Ussing chambers to measure transepithelial resistance (TEER) and paracellular     permeability using fluorescein isothiocyanate dextran (FITC-dx4, MW 4kDa). Expression of bile     acid-sensing receptors (TGR5, VDR, PXR, FXR and CAR) in duodenal biopsies was measured by     western blot and real time RT-PCR. Immunohistochemistry was used to evaluate eosinophil and     mastcell infiltration in duodenal biopsies of FD patients and HV. Duodenal fluid aspirates     were collected at fixed time points during 1 hour in fasted state and 1.5 hours after a     liquid meal (Nutridrink, 200ml). Concentration and composition of the bile salt pool     (including glycocholic acid (GC), taurocholic acid (TC), glycochenodeoxycholic acid (GCDC),     taurochenodeoxycholic acid (TCDC), glycodeoxycholic acid (GDC), taurodeoxycholic acid (TDC),     glycoursodeoxycholic acid (GUDC) and tauroursodeoxycholic acid (TUDC)) in these aspirates was     evaluated by liquid chromatography-mass spectrometry-selected ion monitoring analysis     (LC-MS/MS).   "
21584|NCT03003052|"     This purpose of this database is to collect, store and use appropriately derived data from     routine patient care in a specialist dental practice. Comprehensive observational data will     be gathered, systematically organised and be continuously updated. This data will be used to     evaluate treatment outcomes and identify areas for improvement. This will contribute to the     existing evidence base to validate new and current clinical concepts in dentistry. Patient     consent will be sought for this, and all data extracted from patient notes will be stored and     used anonymously. Use of the Oral Health Impact Profile (OHIP) -14 questionnaire pre and post     treatment will be used to assess patient satisfaction with outcomes.   "
21585|NCT03003039|"     The purpose of this study is the area under the curve (AUC) for GB241 and rituximab     concentrations.   "
21715|NCT03001349|"     The goal of this clinical research study is to use 68GA-DOTATOC instead of the     standard-of-care 111-In-pentetreotide as a tracer chemical during PET/CT scans for diagnosing     neuroendocrine tumors. A tracer is injected into your bloodstream to help the study doctor     see possible tumors.   "
21571|NCT03003221|"     Participation in routine dental care is a significant challenge for children with autism     spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD     symptoms and associated anxiety and behavioral challenges. Lack of routine, effective dental     care has contributed to a substantial unmet healthcare need for children with ASD, who are at     increased risk for excessive plaque, caries, and oral infections.      The purpose of this study is to test a parent-training intervention designed to improve home     dental hygiene, compliance with dental office visits, and oral health outcomes in children     with autism spectrum disorder. Families of children ages 3 to 13 years with an existing     diagnosis of ASD will be recruited for participation. All families will receive the Autism     Intervention Research Network on Physical Health (AIR-P) Dental Toolkit, which is designed to     provide parents with guidance and information about dental care and support strategies for     children with ASD. Some families will also participate in a 10-week behavioral     parent-training intervention focused on improving home dental care and dental office visit     experiences.      The study has three primary aims: 1) To improve children's functional and behavioral     compliance with home dental hygiene, 2) To improve children's oral health, and 3) To reduce     child anxiety and improve compliance with dental visits.   "
21572|NCT03003208|"     Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.     Patients with COPD are at increased risk of developing cardiovascular disease such as heart     attacks and strokes. A simple measurement called arterial stiffness is a good assessment of     how likely people are to have cardiovascular disease, both in healthy populations and those     with COPD. Aortic Pulse wave velocity (aPWV) measures arterial stiffness,      Pulmonary Rehabilitation (PR) - a 6 week supervised group exercise and education class - is     an effective intervention in COPD to reduce symptoms, improve exercise performance and     prevent exacerbations. However, the effect of PR on cardiovascular risk in COPD is     controversial as two small positive studies suggested benefit and one larger study did not.      Investigators have recently shown that cardiovascular risk is higher in those COPD patients     who get the most infections (exacerbations). PR is an effective intervention for preventing     COPD exacerbations. Logically, the exercise component would be expected to reduce     cardiovascular risk too.      Investigators want to identify which patients with COPD get cardiovascular benefit from a PR     programme and why others do not. Investigators propose to measure aPWV before and after PR.     Investigators will then classify participants as responders or non-responders defined as the     presence or absence of a significant improvement in aPWV. Investigators will be collecting     demographic and clinical information including daily physical activity level and how     effective the PR has been to enable the investigators to identify the characteristics of     patients who do, and do not achieve cardiovascular risk reduction in response to PR in COPD.     This will inform on better design of PR programmes for people living with COPD.   "
21573|NCT03003195|"     The purpose of this research is to compare the effects of using a new experimental vaccine     with standard treatment in treating metastatic cancer.   "
21574|NCT03003182|"     This prospective cohort study aims to establish prognostic models, to discover toxicity     associated predictors and to validate randomized trials in clinical practice.   "
21575|NCT03003169|"     This is a prospective observational study, involving 550 mastectomies in Lorraine Institute     of Oncology, to assess care patients management of ambulatory surgical compared to standard     surgery procedure.   "
21576|NCT03003156|"     This trial attempts to investigate whether the dosage (frequency) has an effect on the     treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among     schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST,     while the other half will be recruited to 50 Hz MST.   "
21577|NCT03003143|"     Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients   "
21578|NCT03003130|"     This is a randomized, split face, multicenter study to evaluate the efficacy and safety of     Restylane Defyne compared to Restylane in correction of NLFs.   "
21579|NCT03003117|"     The purpose of this study is to conduct a randomized controlled trial among 800 socially     disadvantaged pregnant women and their families to test the effectiveness of a     multi-component home visitation nutrition program, compared to usual care, in promoting     healthy feeding practices and growth in young children.   "
21580|NCT03003104|"     The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied     twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of     participants will receive DMT210 Gel while the other half will receive vehicle control.   "
21581|NCT03003091|"     In patient education, the amount of information that is not proper with the individual     patient, such as too much or too little, can increase anxiety to patient. Needs-based patient     education has been developed to determine the proper amount of information and provide the     education based on patient needs. This study aims to compare needs-based patient education to     traditional patient education in how they affect preoperative anxiety and patient     satisfaction.   "
21582|NCT03003078|"     The purpose of this research study is to investigate the safety of an active implantable     (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer,     in conjunction with Standard of Care (SOC)chemotherapy. OncoSil™, is an experimental     treatment and carries the active treatment radioactive Phosphorous (32P) inside inactive     silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour     permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a     targeted tumour to destroy cancer cells. Patients will be taking part in a single arm open     label research study - which means that everyone in the research study will receive the     investigational treatment OncoSil™, plus their prescribed standard chemotherapy regimen which     will be either; FOLFIRINOX (FOLFIRINOX is the name of a combination of chemotherapy drugs     used to treat advanced cancer of the pancreas) or gemcitabine + nab-paclitaxel     (Abraxane).Participation in this research study involves a Screening Period, a Treatment     Follow Up Period and a Long Term follow up period. At the first screening visit, every     patient will be asked to sign a consent form to agree to the study procedures, before any     assessments are performed for the study. The total number of visits patients will need to     attend will depend on how long it takes for their disease to progress. The implantation of     OncoSil™ will be completed in the endoscopy suite of the hospital under endoscopic     ultrasound. This allows the specialist doctor to view the pancreas and enables them to     implant the OncoSil Microparticles via a fine needle directly into the target tumour. After     the procedure, there will be a 4 hour observation period to ensure that the patient is     feeling fine and safe to go home. Implantation will only occur once during the treatment     period, and once implanted, the device cannot be removed. After the patients target tumour     shows progression on imaging, there will be an end of study visit and then the Long Term     follow up period will be conducted. The Long Term Follow up does not require the patient to     return to the research study site, it is done via review of the patient's medical records by     site staff every 8 weeks for a maximum of up to 30 months.   "
21586|NCT03003026|"     An assessor blinded multi-centre randomized controlled trial will be conducted in which 60     participants will be randomized to either a novel task-specific approach to training bike     skills or a parent-led home program comparison group. Baseline assessment will take place     within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a     week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The     primary outcome is attainment of individualised two-wheel bike specific goals at T1. All     statistical analysis will be conducted on an intention-to-treat basis. Logistic regression     will be used to assess the effect of providing the novel intervention compared to the     parent-led home program on bike-specific goal attainment.   "
21587|NCT03003013|"     Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich     fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical     trial   "
21588|NCT03003000|"     To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison     to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess     the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a     400 mg ibuprofen tablet and a placebo tablet.   "
21589|NCT03002987|"     In a cluster randomized design it will be investigated whether teaching local leaders how to     implement active pregnancy policy results in less sickness absence among their pregnant     employees. Further it will be investigated to what extent Active pregnancy policy is     implemented at the departments and whether it results in higher sense of security and     wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will     be analyzed.   "
21590|NCT03002974|"     The purpose of this study is to evaluate how anakinra relieves pain for patients with acute     gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The     patients will be divided in different treatment groups to compare anakinra to the available     drug triamcinolone.   "
21591|NCT03002961|"     A multi-center, open-label, single ascending dose study to enroll opioid dependent     treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and     high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of     RBP-6000 after receiving suboxone tablets for 7 days.   "
21592|NCT03002948|"     Topography and location of clitoris and its parts may affect the orgasm   "
21593|NCT03002935|"     This is an open-label, Phase I study of the bioavailability and safety of BPM31510     administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose     is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.   "
21594|NCT03002922|"     To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after     exercise compared to the full coverage observed prior to exercise   "
21595|NCT03002909|"     the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine     wound infiltration versus epidural analgesia on the inflammatory cytokines response after     abdominal cancer surgery   "
21665|NCT03001999|"     The focus of this study is to examine the feasibility, acceptability, and preliminary impact     of a customized, combined positive psychology and motivational interviewing (PP-MI) health     behavior intervention in a group of patients with type 2 diabetes (T2D).   "
21597|NCT03002883|"     Community colleges have 45% of the nation's undergraduates and have a higher smoking     prevalence rate than 4-year colleges. California's community colleges comprise the nation's     largest higher education system, and Sacramento has the second largest community college     district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers     enrolled at community college campuses need greater support. However, community colleges may     lack the student health clinic resources that 4-year colleges have for students who live on     campus. Little evidence to date demonstrates effective interventions for smokers on community     college campuses.      This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation     interventions, compared with usual care on a community college campus. The first intervention     was based on a promising model of brief motivational interviewing delivered by peer     educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails     (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The     second intervention was based on direct enrollment into the California Smokers' Helpline,     which has demonstrated utility for promoting smoking cessation among young adults with low     socioeconomic status. Usual care consisted of students going to the student health center for     smoking cessation assistance.   "
21598|NCT03002870|"     The purpose of this study is to collect and analyze data on the characteristics of women who     are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as     part of their standard medical care. Data collected will contribute to the development of     guidelines for the surgical management of endometriosis. In addition, specimens will be     collected for future testing regarding diagnosing, and/or staging of endometriosis, or     suspected endometriosis, pain and infertility.   "
21599|NCT03002857|"     The most used airway management strategies are different types of supraglottic airway devices     (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .     Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of     this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®     with I-gel and LMA-C regarding their insertion times, durations, perioperative complications     and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures     in urological surgery as well.   "
21600|NCT03002844|"     BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in     patients who had NSCLC with EGFR mutations. In the study, the investigators want to use     EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients     with both EGFR mutation and BIM deletion polymorphism.   "
21601|NCT03002831|"     The purpose of this study is to determine whether Cytokine induced killer cells combined     chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.   "
21602|NCT03002818|"     This is an observational, prospective, open-label, single-arm, multicenter, real-life study     designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen     (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in     participants with Hepatitis C Virus (HCV) genotype 1 (GT1).   "
21605|NCT03002779|"     The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its     metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical     structure of predominant metabolites in healthy adult male participants after a single oral     dose of 500 milligram (mg) 14C-JNJ-53718678.   "
21606|NCT03002766|"     By this non-randomized prospective study, it's evaluated the outcome of patients underwent     BCS for DCIS at whom an established score system to address adjuvant therapies have been     prospectively applied, according to the wideness of free margins.      Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.   "
21607|NCT03002753|"     The purpose of this study is to assess and compare the overall efficacy and differential     effects of detached mindfulness and cognitive restructuring in the treatment of patients with     obsessive-compulsive disorder.   "
21608|NCT03002740|"     In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with     oral anticoagulants (OAC) in routine clinical practice in England, this study will describe     patients treated with each OAC, and to estimate and compare event rates of treatment     discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.   "
21609|NCT03002727|"     Microsatellite instability is more common in colorectal cancer ( CRC) young patient which is     associated with good prognosis and is considered as a predictor for good response to     preoperative chemoradiotherapy. Counting of ( cluster of differentiation) CD 133 +ve cells     ,as a marker for enrichment with colorectal cancer stem cells ,is considered as a prognostic     marker for poor survival and predictor for radio-resistance. Correlation between     microsatellite status ( MS) and CD133 count has not yet studied especially in young patients     with rectosigmoid cancer. So the investigators hypothesize that there is correlation between     microsatellite status, CD133+ve cells count , occurrence of CRC in young patients and     resistance to standard treatment regimen. Improvement of response to treatment and choice of     the best regime to avoid non beneficial treatment modality are the goal of this study.   "
21610|NCT03002714|"     The purpose of this study is to determine and compare the effects of two sessions of     resistance exercise in blood pressure reactivity to a mental stress test in older     hypertensive women.   "
21611|NCT03002701|"     Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with     serious short- and long-term consequences. This study focuses on a program of standardized     nursing and physical therapy interventions to prevent delirium in the ICU, and determines the     effect of the program on the number of delirium-coma-free days in 28 days and several     secondary outcomes in a multicenter randomized controlled trial.   "
21612|NCT03002688|"     The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract     surgeries to assess if the second experience of cataract surgery differs from the initial     experience.   "
21613|NCT03002675|"     The obesity epidemic has led to a enormous increase in the prevalence of type 2 diabetes     mellitus (T2D), dyslipidemia and cardiovascular events. Particularly South Asians, who     comprise 1/5 of the world population, are at increased risk of developing a disadvantageous     metabolic phenotype and these diseases. Moreover, T2D occurs at a younger age and at a lower     BMI when compared to white Caucasians. Recent research has shown that South Asians not only     have a lower energy expenditure than their Caucasian counterparts, but also less active brown     adipose tissue (BAT).      For some time, it has been known that adult humans have active BAT. This metabolic tissue     produces heat by combusting triglycerides, in contrast to white adipose tissue, which stores     this form of energy. It has been shown that activation of BAT has a positive effect on whole     body metabolism, via increasing energy expenditure and improving glucose- and lipid     metabolism. For this matter, BAT has been proposed as a major key player in energy     homeostasis, which may be implemented in the current combat against the obesity epidemic.     Aside from cold exposure, more research focuses on pharmacological activation of BAT.      Glucagon-like peptide 1 (GLP-1) is an incretin hormone which is produced by intestinal     L-cells and upon food intake stimulates insulin secretion by pancreatic beta cells. The GLP-1     analogue Exenatide is a currently much used antidiabetic drug to reduce hyperglycemia via     this aforementioned mechanism. Beyond its blood glucose-improving effects, Exenatide has also     shown to lower body weight and improve dyslipidemia in T2D patients. Elucidation of the     underlying mechanism of these beneficial effects is highly relevant.      Recent preclinical research in our group has shown that central activation of the GLP-1     receptor through exenatide increases BAT activity and thereby contributes to weight loss and     improvement of dyslipidemia. The aim of this research project is to investigate whether     exenatide is also able to activate BAT and increase resting energy expenditure, thereby     improving glucose- and lipid metabolism and reducing fat mass and body weight in humans.     Moreover, the investigators aim to validate the MRI scan as a novel way to measure BAT     activity. The investigators hope that these forthcoming findings lead to the discovery of new     treatment strategies against obesity.   "
21614|NCT03002662|"     During colonoscopy, body mass index, waist circumference and waist / hip ratio is the     relationship between the cecal intubation difficulty aims to define.   "
21615|NCT03002649|"     The purpose of this study is to obtain preliminary data regarding the safety and efficacy of     Janus kinase (JAK) inhibitor, tofacitinib, in adults with active, treatment-refractory     dermatomyositis.   "
21616|NCT03002636|"     900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia     included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were     divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 ,     severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with     BMI<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women     met inclusion criteria and 900 women received allocated intervention. All patients were     divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and     non-Obesity group(n=300) according to body mass index (BMI) >40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2     and BMI<30 kg/m2.900 patients completed the protocol and related data were analysed.   "
21626|NCT03002506|"     This study will help provide information about how patients with burn handle two antibiotics     (ceftolozane and tazobactam) and use that information to guide dosing recommendations for     these patients. The 12 patients who complete the study will receive a single dose of 3 grams     ceftolozane/tazobactam intravenously. We will collect blood and urine samples to determine     how much of each antibiotic is in the body and urine at various times over a 24 hour period.     This information will be used with previously published information from microbiology     laboratories to perform simulations that will provide recommendations on optimal dosing     recommendations of these antibiotics in patients with burns.   "
21627|NCT03002493|"     The primary objective of this study was to assess the effect of cytochrome P450 3A4 enzyme     (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin mesylate following     intravenous (IV) administration in participants with advanced solid tumors. The secondary     objectives of this study were to assess the safety of eribulin mesylate when co-administered     with rifampicin and assess the safety and activity of eribulin mesylate as a single agent.   "
21617|NCT03002623|"     Background:      The thyroid is a gland at the base of the throat. Thyroid cancer is a disease that people get     when abnormal cells begin to grow in this gland. Researchers believe a new drug called     CUDC-907 may be able to help people with thyroid cancer that has spread or has gotten worse.      Objective:      To see if CUDC-907 will shrink tumors in people with advanced thyroid cancer.      Eligibility:      People at least 18 years old who have been diagnosed with locally advanced and metastatic     thyroid cancer.      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Electrocardiogram (ECG) heart test.      Review of their symptoms and how they perform normal activities      A scan will be performed. Some will have a computed tomographic scan (CT) that takes pictures     of the body using a small amount of radiation. Some will have magnetic resonance imaging     (MRI) that uses a magnetic field to take pictures.      Bone scan (some participants)      FDG PET scan to produce a tumor image.      A sample of their tumor from a previous surgery. They may have a biopsy of their tumor if a     tumor sample is not available from a previous surgery.      Participants will be given CUDC-907 in tablet form. They will take it by mouth once a day for     5 days, then take 2 days off, each week.      While taking the study drug, participants will have study visits that repeat the screening     tests.      After they stop treatment, participants will have 3 follow-up visits over a year. They will     repeat some tests. Then participants will be contacted by phone or e-mail every 6 months....   "
21618|NCT03002610|"     The objective of this study is to evaluate the efficacy of infographics, compared to standard     PLS and scientific abstract format, in presenting information, in terms of understanding and     remembering research results by physicians.   "
21619|NCT03002597|"     The BrainPort vision device is a visual prosthetic designed for those who are blind. It     enables perception of visual information using the tongue and camera system as a paired     substitute for the eye. Visual information is collected from a video camera and translated     into a gentle vibration that is presented to the subject on the tongue. With training users     perceive shape, size, location and motion of objects in their environment. It is a     functional, non-surgical device developed to demonstrate as an aid to the visually impaired.      The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision     device) that enables the blind to appreciate their immediate surroundings and determine the     way the brain interprets the information. Our goal is to determine if the device can be used     in a pediatric population by measuring the subjects' improvement over baseline in any of the     following areas: light detection, light localization, movement perception, and standardized     object recognition tasks after use of the BrainPort.   "
21620|NCT03002584|"     Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ)     in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both     complaining of Gas-Related Symptoms (GRS).      IGQ has been developed previously simultaneously in UK English, French and Spanish through     qualitative research with subject interviews. The conceptual framework of the IGQ assesses     both GRS and their impact on daily life. Similar concepts were identified for both subjects     with IBS diagnosis and general population and complaining of gas-related symptoms.      The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17     items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26     items)   "
21621|NCT03002571|"     Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic     Dermatitis in Pediatric and Adult Subjects   "
21681|NCT03001791|"     The aim of the RCT is to analyse clinical and histopathological particularities for     excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser,     CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone     on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding,     the need for additional electrocoagulation or sutures and patient's postsurgical perception     of pain, other postsurgical effects and use of analgesics.   "
21622|NCT03002558|"     Objectives:      Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on     cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension     (RH).      Secondary objectives: i) to identify the subclinical organ damage profile at baseline and its     association with OSA, and to identify if long term blood pressure control and number of     antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii)     to identify epigenetic profiles and clinical, biological and polygraphic variables with a     predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the     HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in     women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA     diagnosis and treatment in patients with RH.      Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood     pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and     subclinical organ damage variables and biological samples at baseline will be collected from     all the subjects included. A sleep study will be performed in all the subjects at the study     inclusion date. Subsequently, the OSA subjects will be managed as per local standard     practice. Follow-up variables will be annually collected (including blood samples). On the     basis of OSA and its treatment, three cohorts of RH subjects will be defined: control     (non-OSA), OSA-treated and OSA nontreated.   "
21623|NCT03002545|"     This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium     from organic magnesium citrate affects blood glucose control and insulin resistance within     patients with type 2 diabetes (HbA1c> 6%) and how the expression of certain Mg-sensitive     transporting genes is affected .   "
21624|NCT03002532|"     Based on evidence that radiation-induced damage to the hippocampus plays a considerable role     in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain     radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive     function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain     metastases from breast cancer.   "
21625|NCT03002519|"     This study aims to evaluate the safety of intramuscular (IM) administration of PLX-R18 in     subjects with incomplete hematopoietic recovery following HCT.   "
21696|NCT03001596|"     The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus     neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with     locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).   "
21628|NCT03002480|"     This pilot study will investigate the use of thromboelastograph (TEG) to determine the     primary bypassing agent for the management of bleeding in children and adults severe     hemophilia A patients with inhibitors.      The study will evaluate the TEG profile for each of the available bypassing agents (FEIBA and     rFVIIa) in each participating patient, which will then determine which agent provides the     most robust clot formation as measured by the TEG. This study will consist of screening visit     and 2-4 pharmacokinetic studies to determine the best bypassing agent based on the TEG     results. Patients will then be assigned that bypassing agent and dose for the treatment of     their bleeding episodes (Prophylaxis or On-demand). Each patient will be then followed for a     period of 6 months to monitor short-term safety of those patients whose bypassing agent was     modified.   "
21629|NCT03002467|"     The Investigator postulate that the use of PESI in addition to routine clinical practice, as     opposed to routine clinical practice based on clinical judgment alone, will help physicians     to correctly identify PE patients at low-risk of adverse outcomes. Considered that low-risk     patients could benefit from a short hospital stay, aim of this study is to demonstrate that     the use of PESI will lead physicians to discharge these patients earlier, thus reducing the     duration of hospital stay of PE patients (primary outcome).      Outpatients diagnosed with PE at the emergency department (ED) and admitted to participating     units represent the target population      As the availability of DOACs may influence the duration of hospital stay, the secondary     objectives of the present study are:        1. to demonstrate that a shorter hospital stay for low-risk PE patients (independently on          the method used to identify them) will reduce the incidence of hospital-associated          complications and improve patients satisfaction and quality of life, without increasing          the incidence of PE-related complications        2. to demonstrate that the use of PESI, as opposed to clinical judgment alone, will be          associated with a greater proportion of patients discharged early (< 72 hours from ED          admission) or treated entirely at home (< 24 hours from ED admission).        3. to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE          patients        4. to demonstrate that the use of DOACs, as opposed to standard treatment, will be          associated with a greater proportion of patients discharged early (< 72 hours from ED          admission) or treated entirely at home (< 24 hours from ED admission).   "
21630|NCT03002454|"     A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP,     is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology     using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.   "
21789|NCT03000387|"     Medications for smoking cessation are currently only effective in helping a minority of     smokers quit. Drug development is slow and expensive, so there is much interest in optimizing     the effectiveness of existing treatments and medications. Current standard doses of nicotine     replacement therapy (NRT) are not effective for many smokers and in many cases provide less     nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed     study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting     success in those who do not respond to a standard dose of NRT (21mg).   "
21633|NCT03002415|"     Acute dehydration in the elderly is a well-known clinical condition, although situations that     lead to chronic dehydration in the elderly may be quite frequent, but they are poorly     studied. Metabolic changes in body water homeostasis can influence and provide chronic     dehydration status as reduced sensitivity to thirst, antidiuretic hormone and renal inability     to concentrate urine and the presence of chronic diseases and the use of polypharmacy may     also predispose states of chronic dehydration. Due to these facts, a study to detect the     existence of chronic dehydration states in a population of elderly people is highly     justifiable. In addition, understanding whether increased water intake, improving chronic     dehydration, may improve renal function in this population seems to be of great value, since     it is a simple and inexpensive intervention and, if confirmed, it can be taken to     institutions, by family members and health promoters who care for and cohabit with elderly     individuals.      Our main objective is to evaluate the effect of stimulated and calculated water intake (per     kg of patient weight) on the state of hydration and renal function in a population of elderly     individuals. It is also within the scope of this project to evaluate the presence of chronic     dehydration in elderly patients as well as in a subgroup of diabetic patients, and to compare     different methods of evaluation of renal function. Design: Clinical trial Randomized for the     main objective and cross-sectional study for secondary objectives.      The principal hypothesis is that guided water intake improve renal function in elderly     patients.   "
21634|NCT03002402|"     The purpose of the proposed study are to determine if the Internet is a feasible and     acceptable delivery method for cognitive-behavioral treatment for insomnia (CBT-I) in adults     with asthma and comorbid insomnia; and to identify the need for asthma-related content using     qualitative research methods (individual telephone interviews) that may be critical to the     success of an Internet-based intervention in asthma patient populations.   "
21635|NCT03002389|"     Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is     flowing in and out of lungs and how oxygen can move from inhaled air into the blood. Chronic     Obstructive Pulmonary Disease (COPD) is a disease in which patients develop narrowing of     airways, thus, having difficulties breathing air in and out their lungs and also damaging the     lung tissues which patients need to move oxygen from the air into blood.      In this study, two drugs which are already approved by FDA (Anoro and Arnuity) will be     administered to patients who are already known to have COPD. While patients are being treated     with these two drugs (one drug at a time over a month), lung health by using usual testing     methods (CT scan of the lung, pulmonary function test, and blood test) will be assessed in     addition to HXe MRI.      The goal of this study is to prove that the HXe MRI is an excellent imaging test to show the     state of lung health among COPD patients and also to obtain new informations on how lung     health changes with drugs that are already approved by US FDA. This work is anticipated to     help develop HXe MRI as a new clinical test which can guide how to treat patients with COPD     and if new therapies can improve lung health of patients with COPD.   "
21636|NCT03002376|"     This study is being conducted to compare the relationship of patient response to treatment to     changes in tumor environment.   "
21637|NCT03002363|"     The purpose of the current study is to determine if pre-exposure through video modeling will     enhance testing compliance in a population of children who are receiving a diagnostic     evaluation for Autism.   "
21638|NCT03002350|"     Distant metastasis of cancer remains the major cause of cancer death. One of the evidence is     that some rare cells shed from primary tumor exist in the circulation of cancer patients,     which has been proven to be related to cancer relapse and distant metastasis. The number of     circulating tumor cells (CTCs) or the expression status of specific marker(s) on them also     correlated with the disease prognosis and treatment effects, which might change the decision     of treatments. In recent years, as specific disruptive genes were discovered, such as     epidermal growth factor receptor (EGFR) in non-small cell lung cancer,Kirsten rat sarcoma     (KRAS) in colorectal cancer, the response rate to treatment, disease control and survival     have been much improved. However, the molecular information obtained from cancer tissue     depends on repeated biopsies, which is very risky and invasive to cancer patients. By means     of the advances of CTCs sampling technique with genetic analysis, repeated follow-up for     specific gene profiles is possible. However, the protocol has not been well-established and     mature, even the correlation between primary cancer tissue and CTCs remains unknown. To     tackle the problems above, the aims of the project is to isolate high-purity CTCs by the     optically induced dielectrophoresis (ODEP)-based device or other cell sorting techniques and     transfer to next-generation sequencing (NGS) analysis for specific disruptive genes. In the     first year of the project, the investigator will testify and stabilize the platform utilizing     healthy donors' blood and cancer cell lines and adjust the detailed experiment conditions. In     the following year, the investigator will enroll newly diagnosed metastatic cancer patients     with the disruptive gene mutation(s) and follow up the events under gene-based therapy.     Comparison of NGS information between cancer tissue and CTCs will be also made as one of the     major endpoints. In brief, the investigator expect the study could establish a practical     method to get genetic information, to reduce the risk of re-biopsy and to achieve the     ultimate goal of precision medicine.   "
21639|NCT03002337|"     This study's aims are to examine the effects of yoga and aromatherapy on women's stress and     immune function during pregnancy.   "
21640|NCT03002324|"     This study is the second phase of a trial examining decision making about vaccines. For this     phase of this study, the researchers will conduct a 3-arm randomized trial to compare the     current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message,     a new cervical cancer focused message developed by the study team, and a non-vaccine related     control passage among parents of adolescent females. The goal of the trial will be to     determine if the new cervical cancer framed message has an increased impact on intent to have     daughters receive the HPV vaccine over the trial period as compared to the current CDC     message used in the field. Additionally, the researchers will examine the impact both the CDC     message and the new message individually have on intent to vaccinate when compared to the     non-vaccine related control message.      The participant's vaccine beliefs and intent to vaccinate will be assessed through an online     survey at baseline. Two weeks later, participants will be randomized to view one of the three     messages: the current CDC message, the cervical cancer framed message, or a non-vaccine     related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will     be assessed to determine the impact of the message.   "
21641|NCT03002311|"     This study's purpose is to test the effects of an electronic health intervention platform     developed by Epharmix, which features two-way SMS text messages and phone calls intended to     improve clinical outcomes compared to the standard of care. The investigators hypothesize     that this system can improve frequency and quality of data gathering across various     specialties, leading to expedited provider intervention and improved health outcomes.   "
21642|NCT03002298|"     With the growing accessibility of computer-assisted technology, one option for rehabilitation     programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality     environments to enhance motor practice. Thus, it is important to examine whether performance     improvements in the virtual environment generalize to the natural environment. To examine     this issue, we had 64 individuals, 32 of which were individuals with DMD and 32 were     typically developing individuals. The groups practiced two coincidence timing tasks. In the     more tangible button-press task, the individuals were required to 'intercept' a falling     virtual object at the moment it reached the interception point by pressing a key on the     computer. In the more abstract task, they were instructed to 'intercept' the virtual object     by making a hand movement in a virtual environment using a webcam.   "
21643|NCT03002285|"     Introduction: Cerebral palsy (CP) is a non-progressive disorder in the brain which makes the     control and execution of movements difficult. One of the possible ways to analyze motor     control in these individuals could be through analysis of movement speed and accuracy.     Objective: To verify the speed-accuracy trade-off in individuals with CP. Method: 96     individuals were evaluated, 48 with CP and 48 with typical development (TD), matched by age     and sex. The software used was the Fitts' Reciprocal Aiming Task v.1.0 (Horizontal),     performed on a computer using an external optical mouse, with progressive indices of     difficulty (IDs): ID2, ID4a and ID4b. Each index of difficulty was performed three times and     the total time/touches captured.   "
21644|NCT03002272|"     In this observational study, we will enroll subjects who underwent TAVR or SAVR more than 3     years ago. Clinical and procedural data from the implant/surgery will be collected, alongside     clinical and echocardiographic data from subsequent follow-up visits.   "
21645|NCT03002259|"     Background. Numerous studies have investigated high-dose corticosteroids in cardiac surgery,     but with mixed results leading to ongoing variations in practice around the world. The     Dexamethasone for Cardiac Surgery-II Trial (DECS-II) is a study comparing high-dose     dexamethasone with placebo in patients undergoing cardiac surgery.      Methods. We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic,     multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the     DECS-II study design (objectives, end points, target population, balanced clusters based on     practice preference with post-randomization consent, treatments, patient follow-up and     analysis).      Conclusions. The DECS-II Trial will use a novel, efficient trial design to evaluate whether     high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing     the number of days at home after cardiac surgery.   "
21646|NCT03002246|"     This trial is a collaborative study between 5 sites worldwide. A total of 600 research     subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software     to improve on estimated fetal weight predictions over a broad range of gestational ages. The     purpose is to compare the accuracy and precision of birth weight predictions based on this     new technology as compared to the current 2D birth weight prediction models.   "
21647|NCT03002233|"     This study is a 2-part study.      Part A is a single-dose, open-label study design to determine the PK, safety and tolerability     of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who     require hemodialysis.      Part B is a multiple dose, open-label study design to determine the PK, PD, safety and     tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory     uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).   "
21648|NCT03002220|"     Radium-223 is indicated for the treatment of patients with mCRPC with symptomatic bone     metastases and no known visceral metastatic disease. However, very few data have been     reported in patients with mCRPC who are asymptomatic or mildly symptomatic. Recently, results     from an International Expanded Access Program have also suggested a benefit of radium-223 in     asymptomatic patients with mCRPC. In addition, the mechanism of action of radium-223 should     not be correlated with the presence/absence of the AR-V7 mutation, although this issue has     not yet been evaluated.      The aim of this study is to assess the efficacy of radium-223 in asymptomatic patients with     mCRPC, and to establish the association between AR-V7 status and radium-223 activity.   "
21649|NCT03002207|"     In this prospective study the investigators seek to evaluate clinical outcomes after     repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during     microendoscopic discectomy for participants of lumbar disc herniation.   "
21650|NCT03002194|"     This study will measure the difference in skin elasticity in females only before and after     treatment with radiofrequency and pulsed electromagnetic field therapy.   "
21651|NCT03002181|"     The effect of a 70 minute Pain Neurophysiology Education session on Sport Therapy Students     Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain   "
21652|NCT03002168|"     The Investigator hypothesizes that the currently used dose of dietary ingredient     alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared     with placebo. The proposed studies will address the degree to which α-CD increases dietary     fat loss.      The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester,     Minnesota.   "
21653|NCT03002155|"     People with diabetes are at risk for life altering complications, including diabetic foot     ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing     weight on their affected limb for months. These long periods of non-weight bearing can result     in severe physical deconditioning, putting these individuals at risk for further health     decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a     seated exercise program on clinically meaningful outcomes in people with diabetic foot     ulcers. The long-term aim of this research is to improve overall health and quality of life     in people with complications from diabetes.   "
21702|NCT03001518|"     The goal of this pilot study is to evaluate and describe the immunologic and overall outcomes     of subjects who undergo routine pancreatectomy with or without irreversible electroporation     (IRE) for pancreatic cancer. Immunologic markers in the blood will be measured at several     time points before and after surgery to determine if surgical approach is associated with     different immunologic responses. Secondary outcomes will include mortality and morbidity;     operative time; blood loss and transfusion requirements; and oncologic outcomes such as:     margin status, lymph node harvest, disease-free survival, and overall survival. Analysis of     immune response will help the investigator determine whether to expand the pilot into a     larger study.   "
21654|NCT03002142|"     Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with     hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive     to presbycusis and/or to central auditory dysfunction.      Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis     of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric     tests as noisy and/or dichotic tests, are needed.      Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease;     therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now,     investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored     the hearing ability of the patient. However, the major part of care management and     investigations implies the patient's communication ability with caregivers. Hearing loss may     be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory     rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline     but this management must be investigate during longitudinal studies in order to demonstrate     their efficiency and need to be compared with a placebo.   "
21655|NCT03002129|"     In this study, the investigators propose to investigate a novel technique for fluid     responsiveness prediction. It is based on the occurrence of an extra systole, which induces a     preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with     decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.      Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but     is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the     hemodynamic effect of increasing preload, i.e. giving fluids   "
21656|NCT03002116|"     Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential     diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of     clinical examination, medical history and ankle-brachial index (ABI) measurement, which is     considered the gold standard non-invasive modality for limb ischemia diagnosis. However, in     diabetic patients with suspected arterial ischemia resulting in tissue loss (critical limb     ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial sclerosis     producing incompressible vessels, while clinical signs are subjective and not accurate in     posing definite diagnosis of CLI.      The investigators conducted a proof of concept study of the feasibility of microwave     radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue     loss.   "
21657|NCT03002103|"     This is a prospective, multicenter, open-label, randomized, and controlled trial to test the     superiority of EndoTAG®-1 in combination with paclitaxel and gemcitabine versus paclitaxel in     combination with gemcitabine.      An independent data safety monitoring board (DSMB) will be established to decide on the     recommended dose (RD) of EndoTAG®-1, paclitaxel and gemcitabine to be used throughout the     trial and to monitor the patients' safety and treatment efficacy data   "
21697|NCT03001583|"     Clinical trial comparing two health education programs for obese patients in order to achieve     a substantial and beneficial weight loss, using mediterranean diet. Patients will be     allocated to two groups, one will receive education in diet and lifestyle, and the other one     the same plus cooking lessons. The intervention period is for 6 months with monthly visits     and phone and email contacts in between. An extension observation period of two years is also     planned with 6 months contacts in our clinic, also with phone and email contact available.   "
21658|NCT03002090|"     Iron deficiency is known to negatively impact physical performance, attention, and time spent     doing physical activity. As a result, an iron deficient person must expend more energy to     complete the same amount of work as someone who is healthy. Another interesting relationship     has been observed between exercise training and iron status in that women who participate in     exercise training often have higher rates of iron deficiency than sedentary women. ID is     commonly treated using daily iron supplementation. However, it is currently unknown whether     participating in regular exercise somehow impacts the effectiveness of iron supplementation.     Iron deficient women who participate in exercise programs may potentially benefit less from     iron supplementation than those who do not. Another common treatment for the symptoms of iron     deficiency is the traditional Chinese herbal treatment, Ba-Zhen-Ke-Li (BZKL). While studies     have shown that BZKL impacts expression of some iron-related proteins and increases endurance     performance in rats, no studies have examined the efficacy of BZKL in improving iron markers     or physical performance in humans. This study will compare the efficacy of BZKL in improving     iron status and physical performance with that of ferrous sulfate supplementation. The     Cornell research team will achieve these objectives in collaboration with colleagues at     Kunming Medical University (KMU) in Kunming, China. A double-blind, randomized, placebo     controlled study will be conducted by a Cornell graduate student at KMU. The subjects will be     healthy women, age 18-26 years, attending KMU. Blood samples will be collected and analyzed     for measures of iron).      Subjects will be randomly assigned to receive 50 mg of ferrous sulfate (10 mg of elemental     iron), 6mg of BZKL, or an identical placebo pill twice daily for 8 weeks. Subjects will be     further randomly sub-divided to receive aerobic exercise training or no training during the     8-week supplementation period. At weeks 4 and 8, subjects will perform the same series of     tests as was performed at baseline. The investigators hypothesize that: 1. the women who     train and received iron will have smaller improvements in iron status than those who do not     train 2. The women who receive iron and train will have greater improvements in physical     performance than those who train and do not receive iron, and 3. The women who receive BZKL     will improve their iron status or physical performance more than those who receive placebo.   "
21659|NCT03002077|"     This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive     to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).   "
21660|NCT03002064|"     This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus     5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal     squamous carcinoma patients.   "
21661|NCT03002051|"     To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided     transenteric drainage of PFC or of biliary tree including GB   "
21662|NCT03002038|"     The purpose of this study is to compare annual relapse rate, expanded disability status     scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica     spectrum disorder during a one year follow up through a randomized clinical trial.   "
21663|NCT03002025|"     The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics     (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese     male participants.   "
21666|NCT03001986|"     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,     is a member of the Human Enterovirus species A, family Picornaviridae. Its infection     occasionally leads to severe diseases and death, with central nervous system (CNS) damage.      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated     in animals but no final results of clinical trials, such as attenuated vaccine, subunit     vaccine.      A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase     I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the     results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97%     against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016.     The purpose of phase IVb is to evaluated the safety and efficacy of the inactive EV71 vaccine     in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province,     China.   "
21667|NCT03001973|"     The investigators are registering LN patients at recruited hospitals and developing a LN     database in China. Patients will be follow-up every year, and both baseline and follow-up     information will be entered into the registration system.   "
21668|NCT03001960|"     TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic     stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the     optimum periinterventional drug regimen.      The study evaluates the effect of dual antiplatelet pretreatment on periinterventional     embolic cerebral lesions and bleeding complications in patients undergoing transfemoral     aortic valve implantation (TF-TAVI).   "
21669|NCT03001947|"     The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients     at recruited hospitals and developing a IgAN database in China. Patients will be follow-up     every one year, and both baseline and follow-up information will be entered into the     registration system. All-cause and cardiovascular mortality and a composite renal outcome of     doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of     dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN     database.   "
21670|NCT03001934|"     The investigators are registering all nephrotic syndrome (NS) patients regardless of the     primary causes and developing a NS database in China. Patients will be followed-up and both     baseline and follow-up information will be recorded in the registration system. The treatment     response, longitudinal changes of renal function, renal survival, patient survival, infection     events and acute kidney injury etc, will be analyzed using the NS database.   "
21671|NCT03001921|"     The investigators are registering all HD patients at recruited hospitals and developing a HD     database in China. Patients will be follow-up every 3 months, and both baseline and follow-up     information will be entered into the registration system. The patient survival, technical     survival, patency rate of access, quality of life and residual renal function for HD patients     will be compared using the HD database.   "
21672|NCT03001908|"     Pain pressure measurements, fine wire EMG and real time imaging ultrasound will be used to     determine the relationships between motion, pain perception, and mobility in the glenohumeral     joint. Muscle activity, joint motion, and pain will be measured pre-post randomized     interventions to determine the response to various physical therapy techniques.   "
21712|NCT03001388|"     To determine if transient elastography (TE), when combined with ultrasound (US) pattern     characterization can improve the prediction of progression to a nodular pattern on US.      To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis (CF)     To prospectively assess whether TE data are associated with conventional laboratory markers     of hepatic fibrosis To determine the variability of TE measurements taken at different sites     in the same patient   "
21713|NCT03001375|"     This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior     resection for upper rectal cancer in the period from May 2011 to November 2015, comparison     will be done on splenic flexure mobilization excluding .   "
21673|NCT03001895|"     Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is     overexpressed manifold on prostate cancer cells and is well-characterized as an imaging     biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is     a nuclear medicine procedure based on the measurement of positron emission from radiolabeled     tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA.     The strength of functional imaging methods is in distinguishing tissues according to     metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can     detect prostate cancer lesions with excellent contrast and a high detection rate even when     the level of prostate specific antigen is low.      The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in     locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at     initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.     This is of interest because non-invasive risk stratification may be possible in the future.   "
21675|NCT03001869|"     The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and     as a diagnostic and decision making tool in the management prostate cancer patients.The     primary endpoints of the study are the incidence of adverse events (AE) in the study     population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA     PET/CT vs CT on a per-patient and per-lesion basis.   "
21676|NCT03001856|"     This study was conducted to demonstrate the equivalence of wound outcomes between the     interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture     (IS) methods   "
21677|NCT03001843|"     This study will help to determine if investigators can minimize narcotic use in laparoscopic     gastric bypass patients while maintaining adequate pain control. This will allow     investigators to minimize the negative side effects of narcotics which is a goal in this     population.   "
21678|NCT03001830|"     The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with     severe haemophilia A   "
21679|NCT03001817|"     The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients     with SHTG.   "
21680|NCT03001804|"     The aim of this non-interventional study is to collect primarily the percentage of patients     who receive the full dose of dexamethasone (40 mg orally once daily on days 1, 8, 15 and 22     of the repetitive 28-day cycles, 20 mg in> 75 year old patients) and in the registered     indication under practice conditions.   "
21703|NCT03001505|"     This is an observational, prospective and retrospective registry of patients with pancreatic     cancer treated in Duke University Health System, which will examine patient and treatment     effects on cancer outcomes.   "
21802|NCT03000218|"     A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are     overweight and have liver problems after ursodeoxycholic acid multiple administration   "
21682|NCT03001778|"     Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g.,     increased strength and balance, reduced frailty, fewer falls, improved brain function, lower     mortality risk), yet many seniors have limited access to exercise options due to numerous     barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This     project will overcome common exercise barriers by creating an interactive web-enabled TV     program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an     Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF     residents and administrators will be able to create, use, and evaluate a customizable     exercise program tailored to the individual's preferred type of exercise, intensity, and     duration.   "
21683|NCT03001765|"     Hypothesis:      Patients that were previously discharged from the emergency department with a subsequent     non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early     Reveal LINQ™ Insertable Cardiac Monitoring System placement.      Primary Study Objectives:      To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day     SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™     Insertable Cardiac Monitoring System) in patients with suspected but no previously documented     arrhythmias that result in a clinically actionable event.   "
21684|NCT03001752|"     This is a three-armed randomized controlled clinical trial aiming the estimation of     dimensional alveolar bone changes after insertion of post-extraction implants through 3     different surgical techniques: open flap, open flap and grafting, flapless.   "
21685|NCT03001739|"     Aortic dissection (AD) aneurysm is a common catastrophic aortic disease in clinical setting.     Conservative therapy of heart rate and blood pressure control in the acute phase is the     essential treatment as guidelines recommended. Nevertheless, there is no unanimous optimal     target for blood pressure in patients with AD so far. The American Heart Association and the     Canadian Cardiovascular Society recommend the blood pressure should be controlled to lower     than 140/90mmHg, while for patients with diabetes or chronic renal failure, the blood     pressure target should be no less than 130/80 mmHg. Recently, the Japanese Circulation     Society recommended that the blood pressure should be controlled to no less than 130mmHg.     However, there was few large-scale, randomized, controlled studies reported on the effect of     different blood pressure control levels on the prognosis of patients with AD. Hence, the     intensive control of blood pressure to <120 mmHg, compared to <140 mmHg, may improve the     patients' outcome. Thus, in this study, the effect of intensive blood pressure control     (<120mmHg) with conventional blood pressure control (<140mmHg) on the prognosis of ABAD     patients will be compared, and to identify the therapeutic efficacy of intensive blood     pressure control on the ABAD patients.   "
21686|NCT03001726|"     Investigators assessed the effectiveness of conversional gastrectomy compared with     chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric     cancer with a single non-curable factor.   "
21714|NCT03001362|"     Patients with histologically proven adenocarcinoma of the rectum will receive pelvic     radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5     fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing     chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for     response to treatment and relapse. Salvage oncologic surgery to be offered if there is     failure to achieve complete clinical response or in the event of a loco regional relapse.   "
21687|NCT03001713|"     This project aims to reduce disparities in cardiovascular disease (CVD) risk factor control     and in rates of heart attacks and strokes among the low-income, racially / ethnically diverse     Americans who receive primary care at safety net community health centers (CHCs). To achieve     this important objective, the investigators will adapt a successful clinical decision support     (CDS) system currently used in CVD care at several large, integrated health care systems, to     meet the patient needs and workflow processes of 60 CHCs. The investigators will determine if     use of this CDS improves CVD care, reduces disparities in CVD care and outcomes, and     increases patient engagement in CVD treatment choices, in CHCs. Results of this randomized     trial will help accelerate the translation of major investments in health informatics systems     into substantial clinical benefits for large numbers of high-risk, low-income patients.     Results will also provide a template for CVD care improvement that can be spread to other     CHCs and extended to other clinical conditions.   "
21688|NCT03001700|"     To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon     Catheter in subjects with atherosclerotic peripheral artery disease of the superficial     femoral and popliteal arteries.   "
21689|NCT03001687|"     Acute inflammation induced by surgery and sepsis is complicated by the development of     iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes     intracellular sequestration of iron, decreasing its availability for erythropoiesis. Hepcidin     might be a potential target to reduce transfusion requirements in surgical and sepsis     patients. Vitamin D supplementation might constitute a novel strategy to modulate the     hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that     by using vitamin D supplementation in surgical and septic shock patients, the physicians     could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a     randomised controlled trial to determine the impact of high-dose vitamin D enteral     supplementation on serum hepcidin levels and transfusion requirements after major abdominal     surgery and in septic shock patients.   "
21690|NCT03001674|"     The primary objective of this study is to develop normative hemodynamic data (means and     standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and     3D-echocardiographic analyses.   "
21704|NCT03001492|"     Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is     suggested to be associated with compromized outcomes. Others found that this rise didnot     affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would     affect the IVF/ICSI outcomes.   "
21705|NCT03001479|"     Breast milk is readily accepted as the ideal source of nutrition for almost all infants,     including premature or very low birth weight infants. However, these high-risk infants     require the addition of fortifiers to their milk in order to achieve sufficient levels of     calories, vitamins, and minerals for adequate growth. We are currently using a liquid human     milk fortifier which does not provide sufficient protein intake, requiring addition of a     liquid protein supplement. A new product has been released which provides sufficient protein     in the liquid HMF, without the acidification seen in previous products.      This is a prospective, randomized noninferiority study comparing the safety and efficacy of     the new HMF with additional protein to our current standard of adding additional protein     supplementation on top of the HMF.   "
21691|NCT03001661|"     Induction of labour (where labour is started artificially) is traditionally carried out with     a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is     a mechanical device, known as an osmotic cervical dilator, which provides an alternative to     drugs or surgery. Thin rods of an absorbent material (no active drug present) are inserted     into the neck of the womb (cervix) and, as they absorb fluid, they swell and mimic the     natural process of 'ripening' (or preparing) the cervix. This initial process is important     before contractions begin. Unlike drugs, Dilapan-S does not cause premature contractions     that, when too frequent, may cause the baby to become distressed. The project will compare     cervical ripening using Dilapan-S with the standard use prostaglandin drug. Women with a     single pregnancy, who require induction of labour, and who are not considered high risk, will     be invited to participate. Investigators hope to recruit 860 women from UK maternity units     over 2 years. Participants will have an equal chance of being randomised to the drug, which     is standard practice, or the cervical dilator. The speed in which labour commences, the mode     of delivery and any side effects will be compared. Importantly, investigators shall also     assess patient satisfaction and anxiety during the induction process, by asking participants     to complete a short questionnaire about their experience before they go home after having     their baby. If osmotic dilators are effective investigators expect NICE to consider them an     option alongside other cervical ripening methods.   "
21692|NCT03001648|"     This is a single centre retrospective study in repeated implantation failure patients: < 39     years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred     without implantation, absence of known causes of implantation failures (uterine malformation,     thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).      Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst     banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally.     Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to     standard IVF cycles.   "
21693|NCT03001635|"     60 patients admitted to this ICCU at the Sheba medical Center will be randomly divided in to     2 groups. one group will receive the conventional treatment while the second group will     receive the conventional treatment plus oxytocin infusion for 48 hours. all participants will     undergo echo and cMRI during hospitalization.   "
21694|NCT03001622|"     The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary     goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8     weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and     pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on     clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology     Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis     Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).   "
21695|NCT03001609|"     The purpose of this study is to investigate the Absorption, Metabolism, Excretion and     Pharmacokinetics of a single dose [14C] AC0010 in male Patients With Advanced NSCLC.   "
21698|NCT03001570|"     Nowadays the association between radiotherapy and the anti- Epidermal Growth Factor Receptor     (anti-EGFR) monoclonal antibody Cetuximab represents a valid option in the treatment of head     and neck locally advanced squamous neoplasm and, particularly, of oropharynx carcinoma. Up to     date we have only indirect comparison with the standard curative treatment (i.e. concurrent     radiochemotherapy) and the preliminary data show equivalent efficacy of both regimens. For     this reason, concurrent Cetuximab and radiotherapy is administered in patients not eligible     to chemoradiotherapy. The introduction of Cetuximab has been associated to new kind of     toxicities, especially cutaneous, that have increasingly reported.      The aim of our study is to improve the toxicity/benefit ratio in patients receiving     concurrent radiotherapy and cetuximab for locally advanced head and neck neoplasm. Hence,     this improvement could be achieved by modulating radiation therapy dose per fraction     following Cetuximab pharmacokinetics.   "
21699|NCT03001557|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of     lemborexant (4 dose levels) or placebo taken daily for 4 weeks in approximately 125 male or     female participants, ages 60 to 90 years, with mild or moderate Alzheimer's disease dementia     (AD-D) who complain of disrupted sleep or multiple awakenings at night along with frequent     periods of falling asleep during the day that impact the quality of life of the participant.     The study is designed to determine the dose response of lemborexant on the change from     baseline in actigraphy Sleep Efficiency (aSE) and actigraphy Wake Efficiency (aWE) during the     last week of 4 weeks of treatment in participants with Irregular Sleep-Wake Rhythm Disorder     (ISWRD) and AD-D.   "
21700|NCT03001544|"     This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a     single intravenous dose of TS23 in healthy adults.   "
21701|NCT03001531|"     Preconditioning of regional skin is known to reduce post surgery complications due to     increased perfusion and better skin condition. The aim of this study is to prove that local     heating through a standardized device in patients with spinal cord injury induces no burnings     or other relevant side effects. The investigators expect an increased regional perfusion,     temperature and redness.   "
21728|NCT03001180|"     The study will use participants tissue previously collected and stored in a tissue bank     maintained by the Department of Hematology/Oncology as well as tissue banked in the future     from participants undergoing prescribed surgical resection of vascular anomalies of interest     proposed in this study. The principle investigator and study staff will also obtain blood     from these participants.   "
21706|NCT03001466|"     Cataract is the leading cause of vision loss and blindness in the world,surgery is the only     available option to correct the problem and the major reasons for low cataract surgical rates     include low demand because of fear of surgery, high cost of surgery and poor visual results     but new research raises the hope that someday, cataracts could be cured with simple eye     drops. This is the first report for preparing urea-loaded NPs eye drops for cataract therapy.     Enhancement of the urea efficacy is accomplished by using polymeric NPs based on the     amphiphilic block copolymer Pluronic®F-127 (PF) which is a hydrophilic nontoxic copolymer     widely used as a pharmaceutical excipient for its stabilizing properties and capability to     increase the solubility.   "
21707|NCT03001453|"     The purpose of this study is to compare two medications currently injected intra-operatively     to help decrease pain after surgery in patients undergoing a primary total hip replacement     (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus     bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to     see if one medication works better than the other in managing post-operative pain after THR.     The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate     better pain management in THR patients post-operatively. Both medications are FDA-approved     for post-operative analgesia.   "
21708|NCT03001440|"     Branded bupropion hydrochloride products including ZYBAN and WELLBUTRIN range are approved     for the treatment of smoking cessation and depressive disorders respectively. The Risk     Evaluation and Mitigation Strategy (REMS) for ZYBAN was initially approved in 2010 and     consists of a Medication Guide and a timetable for REMS assessments submission at 18 months,     3 years and 7 years from the date of initial approval of REMS. The present study is a 7-year     REMS assessment to evaluate subjects' understanding of the potential serious risk of     neuropsychiatric adverse events associated with the use of ZYBAN, WELLBUTRIN, WELLBUTRIN SR,     and WELLBUTRIN XL. The assessment will be a 20-minutes Knowledge, Attitudes and Behavior     (KAB) survey and will be conducted among approximately 125 subjects currently using or who     have filled a prescription for a branded bupropion product for smoking cessation within the 6     months prior to survey administration. ZYBAN, WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL     are registered trade marks of the GSK group of companies.   "
21709|NCT03001427|"     This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining     the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop     Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control     BP in individuals with RH. In the parent trial, participants with RH will be randomized to     either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise     and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control     condition.      The current protocol will collect additional assessments of neurocognition (executive     function, processing speed, and memory), endothelial function (brachial artery flow-mediated     dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in     120 participants at baseline, following completion of the 4-month intervention, and again     after one year, in order to examine neurocognitive improvements and their potential     mediators.   "
21710|NCT03001414|"     The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly     dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic     severe PAH on available PAH-targeted medical therapy.   "
21711|NCT03001401|"     The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical     changes and inflammatory profile of normal eyes (matched for age, refraction and corneal     thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may deliver     equivalent or better clinical outcomes than SMILE, by removing less tissue and correcting for     higher order aberrations.   "
21716|NCT03001336|"     The purpose of this study is to investigate the potential association between thyroid     function and diabetes complications in the elderly subjects with type 2 diabetes mellitus     (T2DM).   "
21717|NCT03001323|"     Given the longer half life of insulin degludec compared to glargine /levemir ,investigators     believe that insulin degludec will reduce the rate of recurrent DKA. The investigator will     randomize participants to control and intervention group. Control group will receive     Lantus/Levemir and intervention group will receive degludec. The investigators will call     participants monthly and see them in the clinic every three months.The investigators will     follow them for 1 year and evaluate if there will be a difference in rate of DKA in between     these two groups.   "
21729|NCT03001167|"     This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth     cohort to determine the relationships between early life antibiotic exposure, microbiome     development, and growth.   "
21903|NCT02998905|"     To determine the feasibility of a controlled trial examining the efficacy and safety of     non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention     in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.   "
21718|NCT03001310|"     Achromatopsia is a recessively inherited condition characterised by a lack of cone     photoreceptor function resulting in impairment of colour vision and visual acuity, central     scotoma often with eccentric fixation, disabling hypersensitivity to light (photophobia) and     involuntary eye movements (pendular nystagmus).      Children with CNGB3-related achromatopsia have profound sight impairment from birth or early     infancy. The condition is currently untreatable, but there is a real possibility that a gene     therapy could offer a significant benefit in terms of improved sight and quality of life     (QOL), based on our own and others experience of ocular gene therapy trials )and pre-clinical     data demonstrating improved outcome in CNGB3- related achromatopsia. Possible benefits of     improved cone-photoreceptor function include improved visual acuity; improved colour     perception; and relief from disabling photophobia. Although younger individuals may benefit     most from gene supplementation therapy by virtue of their greater visual plasticity, it is     anticipated that the intervention may offer benefit across a range of ages and the aim is to     define this range. For this reason, participants of various ages will be included; children     will be included only after an acceptable safety profile has been established in adults.   "
21719|NCT03001297|"     A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese     cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in     healthy volunteers.   "
21720|NCT03001284|"     Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system,     may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical     invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed     mechanisms are not elucidated. The investigators aimed to assess left and right ventricular     (LV and RV) function, left atrial (LA) function, arterial function, and     atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV     systolic and diastolic function and RV function were assessed by 2D- and 3D-     echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was     assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by     intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial     function   "
21721|NCT03001271|"     In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and     demonstrates promising therapeutic potential due to it is generally opposite effects to     Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on     systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and     hypertensive subjects.   "
21722|NCT03001258|"     Demand in near vision correction in the community exist in the Bangladesh with a thin     presence of eye- care. This study aimed to test the skill of BRAC service-providers in     identifying presbyopia-cases, to ensure frequent services, meeting the community need. This     was non-inferiority equivalence randomized intervention trial, done during February-June     2015, in six randomly selected sub-districts, where 2059 camp-patients were screened. BRAC     Health-cadres; program organizers (PO), upgraded shasthya- shebikas (USS) and shasthya-     shebikas (SS), were assigned to three different arms consisting two sub-districts through     permuted-block randomization.105 eye-camps were organized with minimum 500 sample per arm.     Sensitivity and specificity was calculated to understand screening performance. Screening     reports were matched with the gold standard by recruiting refractionists.   "
21723|NCT03001245|"     The aim of this cluster randomized trial is to investigate whether the brief, 1+6 session     psychosocial intervention, Interpersonal Counseling (IPC) is more effective than standard     professional treatment (ST) in the treatment of mild or moderate depression among 12 to     17-year-old adolescents in services provided by school health care and counseling     professionals (school nurses, school psychologists and school social workers). The clients     are identified from the pool of adolescents routinely seen in school health care and     counseling services.      A total of 54 school nurses, social workers, and psychologists from all public secondary     schools in the standard education system of City of Espoo, Finland will be trained in IPC in     a three-day workshop in two waves. Each school (plus the one primary care level health care     unit for adolescents in Espoo) is represented by 1-3 trial IPC counselors. In the first wave     the schools are cluster randomized to provide either A) 1+6 sessions of IPC, or B) 1+6     sessions of standard treatment (ST), which consists of psychosocial work as guided by the     workers' own standard professional principles and methods. The workers randomized to deliver     IPC get the IPC training immediately. In the second wave those who delivered ST in the first     wave will be trained in IPC. The data for this trial will be collected from the first wave.     The data collection period is one school year plus follow-up of clients after 3 and 6 months.      The clients are adolescents who have either self-referred themselves, are referred by other     school personnel, or by parents to the services offered in the school due to emotional     symptoms in the school year 2016 -2017 in the participating schools. They are screened with     the BDI at the initial visit to identify depressive symptoms. A diagnostic interview will be     administered to those exceeding a clinical cutoff. Main inclusion criterion is DSM-5     depressive disorder of either mild or moderate severity. Those with current harmful alcohol     use, acute suicidal ideation or behavior, severe depression or anxiety disorder, psychotic     symptoms or very low global level of functioning are excluded and offered other treatment.      The clients will complete self-report questionnaires (BDI) as outcome measures. Their level     of depression symptoms will also be assessed with ADRS scale and their level of global     psychosocial functioning with the CGAS by the project IPC counselors / ST providers.     Moreover, the clients will complete the Young Person's Clinical Outcomes for Routine     Evaluation (YP-CORE) as a measure of global symptomatology after each session. A follow-up     interview at 3 months and 6 months after treatment termination will be arranged. The     K-SADS-PL will be used for diagnostic evaluation, the ADRS and the C-GAS to assess level of     depressive symptoms and global functioning, and the adolescent completes both the BDI and     YP-CORE as self-reports of symptomatology.   "
21724|NCT03001232|"     The purpose of this study is to determine whether movement-oriented dementia care has a     positive effect on quality of life and independence in activities of daily living (ADL) in     nursing-home residents with dementia.      It was hypothesized that movement-oriented dementia care has a positive effect on quality of     life and independence in ADL, as well as on mood, behavior, cognition and physical     functioning, in comparison to regular care.   "
21751|NCT03000881|"     The study investigates the impact real output has on peristomal skin covered by two different     adhesives   "
21725|NCT03001219|"     This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group,     multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in     participants with RA who are inadequately responding to standard-of-care (methotrexate and     anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate     efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the     option of continuing to the extension period of the study.   "
21726|NCT03001206|"     The purpose of this study is to evaluate the effectiveness and usability of the Master     Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.      The purpose of the study is to evaluate the effectiveness and usability of using Master     Caution 12 leads Garment for stress test.      The purpose of the study is to reassess the adequate size of the Master Caution Garment.   "
21727|NCT03001193|"     The study will be designed as a double-blind, placebo-controlled, parallel-group,     dose-finding study with one group treated with placebo and three groups treated with     tafoxiparin in three different infusion concentration levels, respectively. The intravenous     infusion will be initiated by a pre-defined bolus dose infusion.   "
21730|NCT03001154|"     Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but     because of the high financial costs and technical complexity of the past generation of VR     hardware, there has been no large-scale implementation of this promising treatment. The     present study will investigate whether off-the-shelf, commercial VR hardware and software can     be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The     study will recruit n=25+25 participants from the general public suffering from substantial     speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a     therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo     exposure. The waiting-list group will then receive an Internet-delivered VRET treatment     program.   "
21731|NCT03001141|"     This is a prospective, multicenter, non-randomized registry/observational study. The study     will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac     Resynchronization Therapy (CRT) MP device implant from up to 10 centers.   "
21732|NCT03001128|"     The purpose of this study is to collect information about what happens when people pause, or     temporarily stop taking, ART, and to collect blood samples from these people at frequent     intervals. We will also study the safety of pausing ART under close observation.   "
21733|NCT03001115|"     The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis     Suppurativa (HS) participants in normal medical practice.   "
21734|NCT03001102|"     Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms     which purpose is verify the effects of nursing intervention preoperative bathing with 4%     chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the     prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.   "
21735|NCT03001089|"     Water and electrolytic homeostasis is remarkably controlled by the mineralocorticoid pathway     (renin-angiotensin-aldosterone system acting on the renal tubule). However, the neonatal     period in humans is characterized by a reduced ability of the kidney to ensure normal     functions of urine concentration and maintenance of sodium and water balance. This renal     functional immaturity, is associated in the very premature infants (VPT) (born <32 weeks of     amenorrhea (SA)) to an immaturity of the adrenal responsible for a default of aldosterone     biosynthesis . This relative aldosterone deficiency induces difficulties for VPT to adapt to     extra-uterine life when maintaining a positive sodium balance is essential for postnatal     growth. The improvement of perinatal care (antenatal corticosteroids maturation, ventilation     techniques and use of surfactant) have increased the survival of these children .     Nevertheless, extreme prematurity (less than 32 weeks), which concerns nearly 2% of live     births in France, remains associated with neurodevelopmental sequelae in nearly 40% of     children at 5 years .      Secondary hydroelectrolytic disorders with transient mineralocorticoid adrenal insufficiency     is probably one of the factors responsible of these neurological deleterious outcomes as well     as the occurrence of other complications (bronchopulmonary dysplasia, enterocolitis     necrotizing) of extreme prematurity. Indeed, aside from the administration of antenatal     steroids to induce maturation, the prevention of postnatal dehydration reduces the risk of     intracranial hemorrhage in that population. However, high fluid intake are associated with an     increased incidence of patent ductus arteriosus, of bronchopulmonary dysplasia and     necrotizing enterocolitis. This necessitates the evaluation of preventive measures to avoid     such fluid and electrolyte imbalances by a pharmacological approach based on     mineralocorticoid administration in very premature infants, due to the relative aldosterone     deficiency identified in this population.   "
21736|NCT03001076|"     The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe     therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.   "
21737|NCT03001063|"     This stepped wedge, randomized controlled trial will test the effectiveness of a Supported     Self-Management intervention for depression among adults in Vietnam. The intervention will be     delivered at the community level in 8 Vietnamese provinces by primary care providers and     social workers. The intervention group will receive the Supported Self-Management     intervention, while the control group will receive enhanced treatment as usual. The primary     outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World     Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE     (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional     ability and alcohol misuse.   "
21738|NCT03001050|"     The overall goal of doing this study is to improve long term patient function and outcomes in     the healing rates of Rotator Cuffs. The investigators would also like to see if this method     can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.   "
21739|NCT03001037|"     This study will compare patients with low back pain (LBP) to age and gender matched controls     to determine if there are differences between the two groups related to: range of movement,     secondary outcomes (level of disability, quality of life, evidence of depression, anxiety or     stress), movement patterns and demographic characteristics. The first phase will include a     baseline and 3 month follow-up assessment of the LBP patients and controls, including     demographic characteristics, outcome measures, and a physical assessment. The second phase is     an ongoing phase with continued interim assessments of LBP patients only, at 6 and 12 months.   "
21752|NCT03000868|"     This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic     mucosal resection with hot endoscopic mucosal resection. Half of the participants will     receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic     mucosal resection.   "
24200|NCT02968901|"     The purpose of the study is to document the effect of first line dual oral combination     therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in     treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).   "
21740|NCT03001024|"     Responsible Beverage Service Training (RBS) has been shown to be effective and recent     research by this research team has shown that online RBS training (WayToServe®) was more     effective, particularly over time, than usual and customary (UC) RBS training by live     trainers. However, one growing segment of alcohol servers and sellers has been neglected in     RBS training efforts: Hispanic primarily Spanish-speaking servers in predominantly     Spanish-speaking premises. This project will develop and test the first online RBS training     for predominantly Spanish-speaking servers, WayToServe Español, which is culturally and     linguistically appropriate and will fill a gap in evidence-based alcohol prevention     interventions for this underserved population.   "
21772|NCT03000608|"     This trial will be a double-blind, multi-center, randomized, placebo controlled study to     evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up     to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of     mild-to-moderate plaque psoriasis.   "
21742|NCT03000998|"     The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended     levels, particularly for adolescent boys and especially among minority families. Proposed     here is a mobile web application (mobile web app) for personal computers, smart phones, and     tablet computers that will accurately inform parents and adolescent boys about the HPV     vaccination and address unique concerns about its safety and effectiveness for boys. The     BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a     randomized efficacy trial with parents and adolescent boys aged 11-13 years who obtain care     in pediatric clinics in the University of New Mexico Health Sciences Center's Envision     network.   "
21743|NCT03000985|"     The involvement of family members is crucial and improves the prognosis of psychiatric     patients and reinforces therapeutic adherence and reduces the frequency of relapses. For     schizophrenia, the scientific literature clearly shows that it's in the interest of the     patient to offer to his family a psychoeducational program.      Therapeutic education programs are now part of the recommendations of good clinical practice     and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the     hospital and relating to patients, health and territories.   "
21744|NCT03000972|"     This study evaluates the potential negative effect of cement augmentation in the femoral head     on viability of the head. Half of the participants will have the standard intramedullary nail     (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail     plus cement augmentation.   "
21745|NCT03000959|"     This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing     the functional outcome between those patient admitted in the general neurology wards and     stroke units using modified Rankin Scale   "
21746|NCT03000946|"     The purpose of this study is to determine whether somatostatin is more effective that     octreotide in the prevention of post-pancreatectomy pancreatic fistula   "
21747|NCT03000933|"     Australia was one of the countries to implement a universal school-based male vaccination     program - in 2013. This research project will examine the prevalence of HPV among young men     who have sex with men (MSM) who have been offered school-based HPV vaccination.   "
21748|NCT03000920|"     Each year in France, breast cancer affects about 48,000 women and is the first cause of     cancer death in women with 11,900 deaths estimated.      Since 2004, there is a national organized breast cancer screening (OBCS) programme for     asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer     screening department sends a personalized invitation mail to eligible women to perform a     mammogram and a breast clinical examination. One to two reminder mails are sent to women who     have not done the screening after an initial invitation. Despite this programme, almost 47%     of women in France do not participate to organized breast cancer screening.      The Short Message Service (SMS) is an innovative communication tool in the field of health,     immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative,     low-cost, personalized and ecological way to support the OBCS invitation strategy.      The overall objective of this study is to preserve or even better increase participation in     organized breast cancer screening while decreasing the associated costs by including SMS in     our screening invitation procedure.      Two SMS interventions will be tested which will correspond to different phases of the OBCS     invitation procedure. This sequence of interventions leads us to perform three interlinked     trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days     before the initial mail invitation), then two non-inferiority trials for the second phase (     two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the     first postal reminder).   "
21749|NCT03000907|"     Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the     elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a     fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese     people usually perform less physical activity. All this favors the loss of mass and muscular     function (sarcopenia), a key component of the fragility and the functional deterioration.      Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the     prevention of frailty in obese elderly people, as well as to know the main mechanisms     involved in the frailty process.      Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel     intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of     age, obese (BMI ≥30), without criteria of fragility and living in the community. Study     intervention: multimodal and personalized intervention with the support of a personal     trainer that has two main axes of action: a) diet: assessment of nutritional status and     nutritional requirements and establishment of personalized nutritional plan with monthly     dietetic controls and b) physical exercise: a multi-component physical exercise program that     will include aerobic exercise and strengthening, balance and flexibility exercises as well as     a weekly group session of health education, during six months. Main outcome measures (to be     evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia     (according to the criteria of the European Working Group on Sarcopenia in Older People     -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip     strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance     (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in     body composition and distribution of body fat, c) glycemic control (HbA1) and insulin     resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according     to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute     Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis     Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).   "
21750|NCT03000894|"     This study aims to investigate the effectiveness of transdiagnostic nurse-administered     4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care,     compared to standard care alone, for improving sleep and daytime function, enhancing     recovery, preventing relapses, and reducing medication burden in patients with the first     episode of mood disorders.   "
21753|NCT03000855|"     EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage     in unresectable malignant distal CBD strictures when endoscopic retrograde     cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with     covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD     strictures is uncertain.      The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in     unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a     higher 1-year stent patency rate.   "
21754|NCT03000842|"     The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic     regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was     developing a non-invasive device that is able to stimulate the auricular branch of vagal     nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct     stimulation of the vagal nerve. However, there are still no strong evidences about it actions     regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on     heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at     rest and after orthostatic position   "
21755|NCT03000829|"     This multicenter randomized trial will employ in-situ cardiac arrest simulations (mock     codes) to test whether using telemedicine technology to add an intensive care physician as     the copilot for cardiac arrest resuscitation teams influences chest compression quality,     resuscitation protocol adherence, team function, and provider experience.   "
21756|NCT03000816|"     The aim of this phase II trial is to assess the non-progress survival，local control，overall     survival，safety and tolerability of SBRT to treat patients with oligometastases in esophageal     squamous cell carcinoma.   "
21757|NCT03000803|"     The purpose of this study is to examine how the timing of eating changes how the body makes     and uses energy (metabolism). This study will also examine how fat cells respond to insulin     (a hormone that controls blood sugar levels).   "
21758|NCT03000790|"     To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc     Displacement With Reduction   "
21759|NCT03000777|"     The purpose of this study is to evaluate the effects of oral melatonin plus zinc     supplementation in relieving self-reported fatigue in CFS/ME   "
21760|NCT03000764|"     The purpose of this study is to seeking a molecular signature of pathological radiation     induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two     groups of patients distinguished by their individual radiosensitivity. The signature will     integrate recent insights in terms of alternative splicing of mRNAs and level of expression     of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In each     group each expression patterns of candidate HSP proteins potentially predictive of     pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on     cell culture will be characterized.   "
21761|NCT03000751|"     This is a pragmatic stepped-wedge cluster randomized controlled trial to explore variation in     doses used for diagnostic CT by pooling radiation dose data across diverse healthcare     delivery systems.      To compare different strategies for lowering and optimizing dose and identify the barriers     and facilitators to implementing successful dose optimization strategies and standardizing     practice.   "
21762|NCT03000738|"     The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio     could help predict the prognosis of DLBCL and PTCL.   "
21763|NCT03000725|"     The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and     depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a     home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy     by phone to reduce their depression and improve quality of life (QOL); it was developed at     Emory University with CDC funding. The purpose of this study is to adapt Project UPLIFT for     Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to     Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and     mindfulness skills to people with epilepsy by phone to reduce their depression and improve     quality of life (QOL); it was developed at Emory University with CDC funding.   "
21764|NCT03000712|"     The purpose of this study is to evaluate the efficacy and safety of intra-articular injection     of autologous adipose tissue derived mesenchymal stem cells compared after high tibial     osteotomy to negative control in the osteoarthritis patients   "
21765|NCT03000699|"     The purpose of this study is to determine whether computer bias modification for     interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance     use disorders.   "
21766|NCT03000686|"     This study is conducted to examine how GSK2586881, a recombinant human ACE2 peptide,     modulates the acute hypoxic pulmonary vasoconstriction (HPV) response in healthy volunteers.     The study will be single-center, randomized, placebo-controlled and double blind (sponsor     open). Subjects will be randomized to receive a single intravenous (IV) dose of GSK2586881 or     placebo (saline) in a crossover design. The primary objective of the study is to evaluate the     effect of a single IV dose of GSK2586881 on the HPV response in healthy volunteers during     exercise under hypoxic conditions. Approximately 35 subjects will be enrolled for a maximum     of 56 days.   "
21767|NCT03000673|"     To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease     treated with hemodialysis   "
21768|NCT03000660|"     This is a study to determine the safety, tolerability and maximum tolerated dose of     Venetoclax (ABT-199) and dexamethasone in relapsed or refractory amyloid light chain (AL)     amyloidosis patients.   "
21769|NCT03000647|"     The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic     floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple     Sclerosis   "
21770|NCT03000634|"     This study will compare the effectiveness and safety of maintenance therapy with continuous     bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that     alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.   "
21849|NCT02999607|"     With this study we will be able to dose-dependently measure real-time glucose metabolism     changes after non-invasively stimulating superficial parts of the dlPFC, a commonly used     target in therapeutic tDCS applications. This will provide further insight if and how tDCS is     capable to change one of most reliable parameters of brain metabolism.   "
21771|NCT03000621|"     The objectives are to:        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the          plasma of patients with and without liver injuries        2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects          and under stress        3. investigate the dysregulation of circulating miRNA panel and their prognostic and          predictive values in clinical outcomes in identifying patients at high risk for          mortality and acute liver failure.      This trial involves peripheral blood sampling from subjects at their earliest presentation     and remaining stays in the hospitalization in the emergency department. The investigators     will develop panels of miRNAs that are specific indicator of early onset of major organ     failures, and correlate clinical outcomes with these miRNAs.   "
21776|NCT03000556|"     Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about     10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in     Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and     effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA     would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the     treatment would be more difficult and even cause blindness. Therefore, it is of great     practical significance to prevent the recurrence of TCA. However, there is no effective     methods to prevent recurrence of TCA.      0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote     repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium     hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test     effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a     prospective, single center, randomized, controlled pilot study. In this study, 60 patients     with TCA were randomly divided into control group and sodium hyaluronate treatment group and     observed one year.   "
21777|NCT03000543|"     Background:        1. Burden: Recently Bangladesh has introduced mandatory vitamin A (VA) fortification of          refined edible oil while high dose VA supplementations for infants and children are          still in place as part of national program. Thus preschool children are plausible at          risk of hypervitaminosis A.        2. Knowledge gap: Serum VA concentration is not an authenticate indicator of VA status,          while existing deuterium- VA isotope dilution methods to determine whole body VA status          require 3 weeks and not applicable for infants and children.        3. Relevance: Our research group has recently developed a new simplified equation to          measure VA pool size in 4-5 days, highly correlated with compartmental model-predicted          value and estimate VA pool size in adults with high precision. However, it is not clear          whether this new simplified equation also works in infants and children. In this          proposed study, we validate the method in healthy infants and infants with inflammatory          condition as well as in children with adequate and high dietary VA intake.      Hypothesis: (1) Whole-body VA status in infant and children can be estimated without     accounting for fractional catabolic rate in the context of inflammatory condition or higher     dietary VA intake (2) Fortification of commonly consumed food item with VA along with     periodic high dose VA supplementation would increase the risk of hypervitaminosis A among     preschool children in Bangladesh      Methods: Our study comprises two studies. Study 01 will be undertaken in infants while     Study 02 for preschool children. At first we need to undertake one feasibility study to     verify whether the oral dose of 400 μg 13C10 or 13C3- retinyl acetate (isotopic VA) that we     propose to use in this study would work in infants as we observed in adults, secondly,     whether PENTA valent vaccines induce inflammation in infants (plasma CRP as maker) that     closely mimics natural infection. We need such infants with inflammatory condition in Study     01 to answer the question of whether the isotope dilution technique will still work in     children who undergo inflammation. Information of the reliability of the retinol isotope     dilution technique in infectious conditions is important as national dietary assessment     surveys often observe children with chronic or latent infection. To minimize the taking of     multiple blood samples from each infant/child in both studies, a super kid study design     will be adopted that ensure no more than 2 venous blood samples from each infant/child, even     though multiple time points (at least 5 subjects / time-point) over a 28-day study period     will be available for mathematical modelling. In Study 01 a total of 115 infants (9-11 mo)     will receive an oral dose of 13C10- retinyl acetate (400 μg) dissolved in 0.5 mL of sunflower     oil and then blood samples will be taken from 6h to 16th day at 9 different time-points. On     day 16, a single dose PENTA vaccine will be provided to the randomly selected 50% of infants.     On day 17, another type of stable isotopic VA e.g. 13C3- retinyl acetate (400 μg) will be     orally supplemented to all infants. Blood sample will be collected from day 16 to day 28 at     11 different time-points for each of the vaccine and non-vaccine groups. In Study 02 50     children (3-5y) in each of the adequate dietary VA intake group and higher dietary VA     intake group will be enrolled to receive an oral dose of 13C10- retinyl acetate (400 μg).     Blood sample will be collected from 6h to day 28 at 11 time-points for each of the two     groups. Specific activity of 13C10-VA and 13C3-VA from the blood samples will be measured by     liquid chromatography-tandem mass spectrometry (LC/MS/MS). Plasma biomarkers of VA toxicity     e.g. bone metabolism, liver fibrogenesis and VA metabolites will be measured in the children     of Study 02.      Outcome measures/variables: (1) The early time point equation for assessing VA pool size in a     group of infants with or without inflammation and in a group of children with adequate or     with high dietary VA intake. (2) The association between biomarkers of VA toxicity and     estimated liver vitamin A concentration in preschool children at risk of hypervitaminosis A.   "
21778|NCT03000530|"     This is a two-part (open-label followed by double-blind) study evaluating the safety,     tolerability, pharmacokinetics, and efficacy of SAGE-217 in approximately 98 subjects     diagnosed with moderate to severe Major Depressive Disorder.   "
21779|NCT03000517|"     The emergence and spread of multi-drug resistant and extensively-drug resistant strains of     Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and     elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various     factors contributing to the development of drug resistance, low drug exposure is well     recognized. To overcome this, either new drugs have to be developed or the dose of currently     used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and     aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired     drug resistance to these drugs could complicate and narrow down the available options, and     further exacerbate to pre-XDR and XDR-TB.      Objective:      The main objective of this prospective clinical study is to understand the pharmacokinetics     of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body     weight and correlate drug exposure, with treatment outcomes.      Study design:      A prospective pharmacokinetic study      Study population: 20 MDR-TB patients      Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on     the body weight, under MDR-TB treatment regimen of Nepal.      Main study parameters/end points:      The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points     of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for     efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated     in plasma and in oral fluid   "
21780|NCT03000504|"     This study is designed to assess whether a new type of chest drain reduces the number of     drains that fall out of or are accidentally removed from the chest cavity (usually requiring     another drain to be inserted), without causing any increase in discomfort or other     side-effects.   "
21781|NCT03000491|"     This study forms an initial phase of work aimed at developing a learning health system (LHS),     whereby data relating to asthma is extracted from patient electronic health records (EHRs)     across Scotland, analysed to explore variations in clinical practice and then shared with     general practices to highlight any improvements that can be made so that they can better     support people with asthma.      If successful, the investigators hope to progress to the main quality improvement phase     involving an increased number of practices and then incrementally build this up to cover the     whole of Scotland.   "
21782|NCT03000478|"     This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure     Therapy in adult patients with combat related PTSD.   "
21783|NCT03000465|"     Optimizing all factors that increase the intra-abdominal volume and performing an     individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure     while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared     to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15     mmHg).   "
21784|NCT03000452|"     This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the     combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts;     Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will     receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly [QW], every 2     weeks [Q2W] or every 4 weeks [Q4W] of each 28-day cycle) received on their last prior therapy     containing DARA. The dosing schedule for DARA may be adjusted during the course of the study     as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle     1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.   "
21785|NCT03000439|"     A randomized withdrawal study in which responders to open-label treatment with tofacitinib     will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the     double-blind phase time to sJIA flare will be evaluated as primary endpoint and subjects     will be discontinued once they experience sJIA flare. Once 31 flares are reported the study     will be completed.   "
21786|NCT03000426|"     The aim of this study is to compare the influence of two different energy densities for     photobiomodulation on recovery of palatal donor area after free gingival graft technique.   "
21850|NCT02999594|"     Tramadol for labor analgesia: a low risk placebo controlled randomised control trial   "
21851|NCT02999581|"     The purpose of this study is to examine the effects of a pre-workout dietary supplement     during resistance training on training adaptations.   "
21787|NCT03000413|"     Despite few scientific evidence that could support the use of ketamine in adult patients     undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely     employed in this setting. The aim of this study is therefore assess more definitively the     real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and     need for MV in order to establish or refute the use of this drug as standard therapy in     these cases.   "
21788|NCT03000400|"     The purpose of this study is to determine the effectiveness of a multi-professional     theoretically based family centered intervention, The Traumatic Brain Injury Family System     Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics     and functioning. The intervention will be provided in collaboration with the municipal     rehabilitation service. The intervention group will be compared with a control group     receiving treatment as usual, defined as an individually tailored multidisciplinary approach,     and the family members will attend one ongoing psycho-educational group session of 2.5 hour     provided by Oslo University Hospital (OUH).   "
21790|NCT03000374|"     Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance     imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for     preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of     panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response     (pCR)   "
21791|NCT03000361|"     The aim of this study is to assess the feasibility and the safety of the Novel Motorized     Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with     the primary aim to achieve a cecal intubation rate of at least 90 % according to quality     guidelines recommendations. All other clinically relevant quality parameters of standard     colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study     represents the first clinical evaluation of using a motorized spiral assisted endoscope for     examination of the colon with potential advantages for patients in terms of effectiveness and     convenience of colonoscopy.   "
21792|NCT03000348|"     This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis     who are experiencing an exacerbation of CF-associated lung disease. There are six different     potential dosing regimens, including one that is placebo.   "
21793|NCT03000335|"     Previous findings have shown that a biomarker comprised of the three microRNAs (miRs)     miR-451, miR-151-5p and miR-1290 can independently predict precursor B-cell acute     lymphoblastic leukemia (B- ALL) patients' risk for relapse when measured in cells from a bone     marrow (BM) aspiration taken at diagnosis (Avigad et al., 2016: Genes, Chromosomes & Cancer     55:328-339). Curewize Health recognizes that the development of a minimally invasive blood     test for frequent long-term monitoring can greatly benefit pediatric precursor B-ALL     patients. Therefore, the current study will investigate the monitoring ability of miR-451,     miR-151-5p and miR-1290 measured in blood samples. The study will be performed in two stages:      Stage 1-Cross-Sectional Study: Blood samples will be collected from relapsed pediatric B-ALL     patients and B-ALL patients in remission. Blood will be collected from each patient in three     tubes, for serum, plasma and whole blood analysis, in order to interpret the best blood     source for measuring miR-451, miR-151-5p and miR-1290. The level of the miRs in blood will be     compared between relapsed B-ALL patients to B-ALL patients in remission. If the Stage 1     Cross-Sectional study is successful, the investigators will continue the clinical trials to     the Stage 2 Prospective Monitoring study.      Stage 2-Prospective Monitoring Study: Blood will be collected from patients at diagnosis and     at routine clinical follow-up. Patients can be up to five years from diagnosis. The source of     blood found to be most optimal for measuring the miR levels is Stage 1 will be collected. The     final design of the Stage 2 study will be decided after completion of the Stage 1 study.   "
21794|NCT03000322|"     This study is intended to determine the efficacy of the Cooling Vest in reducing the     frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy     treatment for prostate cancer.   "
21795|NCT03000309|"     Sixteen week open label study of apremilast in combination with topical steroids with a four     week safety follow up visit.   "
21796|NCT03000296|"     This study evaluates the safety and clinical benefits of a therapeutics approach of     conditioning regimen Cyclophosphamide (Cy) + Thymoglobulin r (ATG) + Granulocyte     Colony-Stimulating Factor (G-CSF) followed by autologous Hematopoietic Stem Cell     Transplantaion (HSCT) rescue in therapy refractory Crohn's disease. It will be counted     adverse events, clinical and endoscopic condition at various short and long-term time points.   "
21797|NCT03000283|"     The goal of this study is to preliminarily determine/estimate feasibility and whether     frequent and early conivaptan use, at a dose currently determined to be safe (i.e.,     40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral     hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether     conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This     study is also an essential first step in understanding the role of conivaptan in CE     management.      Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and     well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and     pressure.   "
21798|NCT03000270|"     Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in     patients with ST-elevation myocardial infarction (STEMI) is safe and feasible   "
21799|NCT03000257|"     This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2     dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)     profile of ABBV-181. This study will also evaluate the safety and tolerability of ABBV-181 in     combination with Rovalpituzumab Tesirine. The study will consist of 2 parts: ABBV-181     monotherapy dose escalation and expansion, and ABBV-181 in combination with Rovalpituzumab     Tesirine.   "
21834|NCT02999802|"     This research seeks to better understand how cellular and molecular bases of changes     associated with aging contribute to decreased function and increased incidence of disease.     Specific mechanism in muscle responsible for anabolic resistance - a key component of     sarcopenia and frailty - will be identified. The proposed research is relevant to public     health because the discovery of new targets for interventions and novel therapeutics to     improve muscle strength and function, prevent falls, and reduce physical dependency will     improve the healthspan and quality of life in older adults by improving their physical     function and ability to remain independent and healthy for a longer period of time.   "
21800|NCT03000244|"     Background:      People who have had an allogeneic hematopoietic stem cell transplant (HCT) have bone marrow     or an immune system that is damaged. They get stem cells from a donor who is a relative.     Researchers want to study stem cell donors and recipients to learn about the long-term     effects of HCT. They want to learn how the stem cells change and how to improve their ability     to fight cancer.      Objective:      To provide long-term follow-up care for people who underwent or will undergo HCT. To collect     data, blood, and tissue samples to learn about late complications after HCT.      Eligibility:      Adults age 18 and older who will undergo HCT or underwent HCT and are surviving one year or     more from the date of HCT. The stem cell donors for these recipients are also needed.      Design:      Recipients will have 1 visit each year. They will have a physical exam. They will answer     questions about their medical history and health. They will receive screening and     surveillance testing. They will complete brief questionnaires.      Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue     in their cheek or skin or bone marrow biopsy).      Recipients will give their current address and phone number, and the same data for one or two     other people, who can get in contact with them.      After the first visit at the clinic, some recipients may see a doctor close to home to get     the necessary information and send it to NIH.      Donors will come to the clinic for 1 visit. They will answer questions about their medical     history. Blood samples will be taken.   "
21801|NCT03000231|"     The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night     time blood pressure between healthy control subjects and patients with adrenal insufficiency.     No intervention will be administered and the study is observational only.   "
21804|NCT03000192|"     The purpose of this study is to invite all people diagnosed with cancer who meet the     eligibility criteria to complete questionnaires before their treatment begins and at regular     intervals over time to assess the impact of cancer and its treatment on people's lives in the     short, medium and long term. We will explore a range of factors to determine their role in     both recovery of health and well-being and self-management. Although it is known that people     who have had cancer are likely to experience a number of physical and psychological problems     as a result of the disease and treatment, it is not known what the 'typical' course of     recovery of health and well-being looks like, how long it takes and how this can be     influenced. We will determine pathways to recovery of health and well-being following cancer     diagnosis (initially breast cancer diagnosed <50 years, Non-Hodgkin Lymphoma and     gynaecological cancers) and identify what factors influence this. This includes assessing the     relative importance of the person's illness, personal attributes, perceived burden of     treatment, role of the environment they live in, including health / social care and personal     networks of support, and their ability and capacity to self-manage. We will identify who is     most at risk of problems and what environmental supports and resources people are able to     mobilise to support their self-management. We will also explore who has the confidence and     ability to manage during and beyond treatment and what factors influence this and whether     this leads to earlier problem resolution and restoration of health and well-being. This     knowledge will be used to develop and test future supportive interventions to enhance the     rapid recovery of health and well-being - our long term aim being to design ways of helping     people with cancer in areas we identify as problematic for them.   "
21805|NCT03000179|"     This is a single-agent, open label, one-arm phase 2 pilot study of avelumab in patients with     advanced or metastatic adenocarcinoma of the small intestine.   "
21806|NCT03000166|"     The purpose of the study is to determine the impact of a physical activity intervention on     the self-management of fatigue in young adults receiving chemotherapy. Half of the     participants will receive an intervention which includes education and resources to set     physical activity goals and monitor progress toward goals.   "
21807|NCT03000153|"     Recent evidence suggests that focusing on positive goals rather than problems to avoid, may     be associated with better psychological health and attainment of goals. In addition, the     advantages of using personalised measures have been highlighted in a number of studies. The     Goals Form is a new measure that comprises both elements. It invites clients, in     collaboration with their therapist, to identify up to seven goals for therapy typically at a     first assessment session and then to rate them on a 1-7 Likert scale, with 1 being not at all     achieved and 7 being completely achieved. This research is important for clinical practice as     it provides the foundations to identify what might be a helpful factor in counselling and     psychotherapy.      The aim of the study is to test whether the use of the Goals Form leads to better clinical     outcomes in counselling and psychotherapy. Participants in this study are counsellors and     service users at Tower Hamlets Mind. The design of this study is a trial, which looks at     comparing outcome measure scores in 'therapy as usual' and 'therapy using the Goals Form'     when participants are randomly assigned to one of the two conditions. Interventions in this     study involve using the Goals Form at the start of every session and taking part in a 30     minute interview once therapy has ended to give feedback about using the form in therapy . In     addition to assessing outcome, the study also serves to compare satisfaction scores across     the two conditions. It is a pilot to determine the feasibility of such trial including     recruitment rates over a period of a year, adherence of counsellors and clients to the     protocol, and the ethical issues raised.   "
21808|NCT03000140|"     Despite exercise training decrease blood pressure in 'average' terms, there is a wide     interindividual variability after exercise training, being yet unknown what mode of exercise     (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less     non-responder (NR) prevalence (i.e., percentage of subjects who experienced a     non-change/worsened response after training in some outcome).   "
21809|NCT03000127|"     Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are     limited. Several studies have shown that a large proportion of men with MS have low     testosterone levels. We propose a two-site clinical trial using topical testosterone gel as a     treatment for MS-related fatigue in men with progressive MS who have low or low-normal     testosterone levels.   "
21820|NCT02999984|"     This is a prospective, non-randomized, single-cohort, longitudinal, single-center, clinical     study designed to assess the efficacy and safety of a cryopreserved formulation of OTL-101     (autologous CD34+ hematopoietic stem/progenitor cells transduced ex vivo with EFS LV encoding     for the human ADA gene) administered to ADA-SCID subjects between the ages of 30 days and 17     years of age, who are not eligible for an HLA-matched sibling/family donor and meeting the     inclusion/exclusion criteria. The OTL-101 product will be infused after a minimal interval of     at least 24 hours following the completion of reduced intensity conditioning. For subjects     who have successfully received the OTL-101 product, PEG-ADA ERT will be discontinued at     Day+30 (+/-3) after the transplant. After their discharge from hospital, the subjects will be     seen at regular intervals to review their history, perform examinations and draw blood     samples to assess immunity and safety.   "
21852|NCT02999568|"     The purpose of this study is to examine how different levels of physical activity impact the     ovarian reserve during the pre-menopausal period   "
21810|NCT03000114|"     Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing     deformities of the hand. Although numerous treatments exist, the most common and widely     accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery     time, and many patients require multiple surgeries throughout their life as the disease     progresses, with repeat surgeries increasing the risk of complications.      Long recovery times and need for repeat surgeries has renewed interest in minimally invasive     treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid     improvement in finger extension with minimal recovery time. The FDA approved collagenase     clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for     rapid increase in finger extension, also with minimal recovery time. Currently there is only     one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes     in both treatments. Both treatments are minimally invasive, requiring minimal time off work     and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly     in patients with multiple areas of disease requiring treatment. The project proposed will     compare these two methods for treating Dupuytren's disease.      Approximately 334 participants will be recruited from patients referred for treatment to hand     surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be     determined in the usual fashion, and the option for entry into the study will be proposed to     patients meeting inclusion/exclusion criteria. Participants will be randomized into either     the PNA or CI treatment group. The surgeon will not be blinded to the procedure group;     however, the therapist measuring outcomes will be, and the study participants will need to     not divulge to the therapists which group they are in.      Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves     the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle     inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken     it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection     of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to     see the surgeon within one week, has freezing placed in the hand, and the affected digit is     extended to rupture the already weakened cord.      The patient will be required to present to the hand therapist team for measurements of joint     angles before and after the assigned treatment is performed. In order to measure treatment     efficacy, study participants will be required to return for measurements of treated joints     every 6 months. Lastly, participants will need to inform the performing surgeon or therapist,     at follow-up visits of any complications they experience.   "
21811|NCT03000101|"     The aim of this research is to study the effects of a pomegranate juice on calprotectin     levels in patients suffering of inflammatory bowel diseases (IBD) in clinical remission.     Fecal calprotectin levels, surrogate marker of mucosal inflammation, will be measured from     baseline to 12 weeks later (end of intervention). Systemic and mucosal changes of biochemical     and molecular inflammatory response markers will be also assessed.   "
21812|NCT03000088|"     The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an     endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this     study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).   "
21813|NCT03000075|"     This is a randomized double blind, double dummy, placebo controlled, parallel design study     that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).   "
21922|NCT02998658|"     The aim of this study is to estimate whether the use of the barbed suture facilitates     laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.   "
21814|NCT03000062|"     In this study the investigators want to explore the feasibility and effect of a simple     intervention provided by primary care physicians on treatment for overweight in general     practice. Regular patients visiting their ordinary family physician will be asked for     participation if they comply with the inclusion criteria. If so, they will follow a detailed     food list for 12 months with regular visits to the doctor. At each visit, the participating     patients will be asked about their progress on weight loss and all measurements will be made.     Simultaneously a control group of primary care physicians will also recruit patients that     fulfill the inclusion criteria. These patients will also provide data that will serve as     Control to the intervention group.   "
21815|NCT03000049|"     With a completely bedside blood culture diagnostics system (BACTEC blood culture system in     combination with the Accelerate ID/AST System) it is possible to optimize the initial     antimicrobial therapy in patients with sepsis and septic shock.      Prospective observational, open-label mono-center study to compare a completely bedside blood     culture diagnostics system (BACTEC blood culture system in combination with the Accelerate     ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients     with sepsis or septic shock.   "
21816|NCT03000036|"     Twenty-seven breast cancer women without heart failure, underwent CMR imaging (3T-Achieva,     Philips) before and 3 times serially after 4-cycles of adjuvant DOX (60mg/m2). CMR assessed     left ventricular (LV) ejection fraction (EF), T1 mapping pre and post gadolinium and late     gadolinium enhancement imaging. Biomarkers were obtained before and 72 hours after each     DOX-cycle.   "
21817|NCT03000023|"     The study is both qualitative and quantitative, gathering patient's perceptions of HCV     treatment benefits before and after HCV treatment by administering surveys and conducting     in-depth qualitative patient interviews. The study seeks to understand all anticipated and     actual benefits patients perceive before and after viral eradication.   "
21818|NCT03000010|"     The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted     closure (VAC) therapy in the prevention of infection after posterior spinal fusion for     pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.   "
21819|NCT02999997|"     Parkinson's disease (PD) is typically associated with cognitive and movement related     functional disabilities. One commonly described cognitive complaint is the ability to do     several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner     Method (RGM) is a rhythm and music based rehabilitation intervention that includes components     that will train this ability specifically in addition to postural control, motor learning,     movement ability and general cognitive function. The aim with the present randomized     controlled single-blinded trial is to evaluate the RGM with main focus on dual-task     performance, compared to a control group, in individuals with PD. The control group will     continue with everyday activities, including ordinary exercise activities, with no additional     activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention.     Following outcome measures will be analyzed:        1. dual task performance (motor-motor, and motor-cognitive)        2. level of physical activity, motor function and balance        3. cognitive function including memory and spatial function        4. health-related quality of life, fear of falling, and freezing of gait        5. qualitative interviews from focus group discussions   "
21821|NCT02999971|"     The objective of this study is to investigate the relative effectiveness of CCT on water     versus on land in stroke patients. Additionally, the study will to determine if there are     differences in the results obtained, between two CCT programs in the following parameters:     gait, balance and dexterity   "
21835|NCT02999789|"     To conduct a pilot test to estimate the effect of a novel reminder system in improving daily     asthma controller medication adherence rates in children with monolingual Spanish-speaking     guardians who have limited English Proficiency (LEP).   "
21822|NCT02999958|"     Upon collection, human oocytes are fertilized and culture up to the blastocyst stage,     followed by transfer and / or cryopreservation. Culture media systems have been developed     that support each step of this process. Although these culture media systems try to mimic the     natural environment, several components of the in-vivo situation are not present in today´s     media. One such component is anti-oxidants that may protect embryos against damage by     reactive oxygen species.      This investigation aims to compare blastocyst development using 2 different types of culture     media systems, one of which contains antioxidants. Patients having at least eight oocytes and     meeting other inclusion criteria can be included in this investigation.      It is a prospective randomized multicenter study randomly dividing oocytes into two groups     and assessing parameters of embryo development from fertilization up to blastocyst formation     until day six. Embryos with acceptable developmental characteristics can be transferred into     the uterus or cryopreserved for later use.      The investigation is designed as a superiority study comparing utilization rate of     blastocysts per normally fertilized oocyte using both media systems. In patients receiving     embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound     after 12 weeks gestation is the final endpoint of the investigation.   "
21847|NCT02999633|"     Primary Objective:      To evaluate the efficacy of isatuximab.      Secondary Objectives:        -  To evaluate the safety profile of isatuximab.        -  To evaluate the duration of response (DOR).        -  To evaluate progression free survival (PFS) and overall survival (OS).        -  To evaluate the pharmacokinetics (PK) of isatuximab in patients with T-ALL or T-LBL.        -  To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL.        -  To assess minimal residual disease (MRD) and correlate it with clinical outcome.   "
21848|NCT02999620|"     To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as     compared to placebo when consumed with a standardized radiolabeled fatty meal.   "
21823|NCT02999945|"     In this prospective randomized controlled multi center trial the investigators stratify Very     Low Birthweight  (VLBW)-infants with growth retardation in small for gestational age (SGA)     or intrauterine growth restricted (IUGR) - infants and aim to investigate the impact of a     nutritional management with enhanced nutrients from discharge up to the 52nd week of     postconceptional age on growth, body composition, metabolic programming, metabolomics,     microbiome and long term neurodevelopmental outcome. In this study, the investigators will     evaluate the difference in metabolic profiles of SGA and IUGR preterm infants. The     investigators will further longitudinally assess, how different nutritional interventions     affect the altered pathways in the first year of life and identify, in combination with data     available from metabolic markers, microbiome and breast milk analysis, potential pathways     resulting in increased disease risk later in life.   "
21824|NCT02999932|"     Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the     mortality in patients staying longer than 72 hours in ICUs.   "
21825|NCT02999919|"     Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress,     dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery.     Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced     cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this     study investigated the influence of body mass index (BMI) on PDPH in elective caesarean     section patients in whom 27G spinal needles were used.   "
21826|NCT02999906|"     This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind,     placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are     currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at     randomization for their PAH. Once randomized, subjects will return for 5 study visits up to     Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition     to the open-label period of the study for up to 20 weeks.   "
21827|NCT02999893|"     The purpose of this study is to determine whether APR-246, 5-FU and cisplatin are safe and     effective in the treatment of platinum resistant oesophageal cancer.   "
21828|NCT02999880|"     the importance of this study is to evaluate the clinical performance of direct anterior resin     composite restoration constructed using innovative esthetic dual-shade technique and another     restoration constructed using polychromatic natural layering technique with various finishing     and polishing steps.      The benefit from carrying out this study is to help the practitioners to decide the most     suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with     superior clinical performance direct anterior resin composite restoration.   "
21829|NCT02999867|"     This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean     intervention for health improvement in patients with type 2 diabetes.   "
21830|NCT02999854|"     The primary objective of this study is to compare safety and efficacy of a haploidentical     T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell     replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in     patients with a hematologic malignancy. An additional objective of the study is to compare     the effect of the two treatments on quality of life.   "
21831|NCT02999841|"     Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2     ≤ body mass index ≤ 30kg/m2).      50 participants per arm (acarbose & lifestyle combination / vildagliptin & lifestyle     combination), using abdominal computed tomography scans and other methods to evaluate the     effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity     patients with newly diagnosed type 2 diabetes.   "
21832|NCT02999828|"     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,     is a member of the Human Enterovirus species A, family Picornaviridae. Its infection     occasionally leads to severe diseases and death, with central nervous system (CNS) damage.      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated     in animals but no final results of clinical trials, such as attenuated vaccine, subunit     vaccine.      A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase     I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the     results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97%     against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016.     The purpose of phase IV is to evaluated the safety and efficacy of the inactive EV71 vaccine     in large scale population of Chinese children (from 6 to 71 months old).   "
21836|NCT02999776|"     The purpose of this study is to assess the feasibility and safety of topical administration     of etanercept via AFL micropores to psoriatic plaques in patients with mild to moderate     plaque-type psoriasis.      While a wide variety of therapeutic innovations to treat moderate-to-severe psoriasis     (accounting for around 30% of the cases) become available each year, there are few     innovations for topical therapies to treat mild/localized psoriasis (accounting for around     70% of the cases). Given that only about half of the patients respond adequately to the     current standard of care, the topical application of a fixed combination of calcipotriole and     betamethasone, there is a medical need for better topical therapies.      Etanercept has been used successfully to treat moderate-to-severe plaque-type psoriasis in     children and adults for more than a decade. Its standard route of application is through     subcutaneous injections. Different dosing regimens have been used: 1 x 50 mg or 2 x 50 mg per     week as well as 1 x 25 mg or 2 x 25 mg per week. Under these regimens, etanercept has a     well-established favorable long-term safety record, with injection site reactions (pain,     swelling) the most frequently reported side effects. However, rare but serious side effects     such as serious opportunistic infections resulting from immune system inhibition common to     anti-TNF agents limit its systemic use to these patients. For this reason, a localized     topical alternative route of administration would be desirable. However, the large molecular     size and chemical nature of etanercept prevent it from crossing the epidermal barrier. A CE     certified ablative fractional laser (AFL) device with Er:YAG source will be used to create     micropores in plaques to allow local delivery of etanercept directly into psoriatic plaques.   "
21837|NCT02999763|"     Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape     device for non-invasive abdominal fat and circumference reduction.      Study subjects will undergo SlimShape treatments on the abdominal area.   "
21838|NCT02999750|"     The purpose of this study is to prospectively validate treatment benefit of an individualized     treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue     sections obtained before the start of treatment (real time biopsy).   "
21839|NCT02999737|"     The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy,     generating interest across a wide variety of medical specialties, such as orthopedics,     dentistry, ophthalmology, and dermatology. Several recently published studies have     demonstrated efficacy in treating androgenetic alopecia (aka male or female patterned hair     loss), but each varies in the treatment protocol, and there is no evidence-based data to date     guiding the dosing parameters of and intervals between injection sessions. We propose a     single-center, single-blinded randomized pilot trial to investigate the most beneficial     number and frequency ('schedule') of necessary PRP injections in men and women with     androgenetic alopecia.   "
21840|NCT02999724|"     Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that     this medication can help reduce pain after surgery, including hysterectomy, where the uterus     or womb is removed. Opioids are the first choice for pain medication administered after     surgery, but carry significant side effects. Several studies have demonstrated that if     patients are given gabapentin before surgery, they require less opioids after surgery.     However, there have not been any studies examining gabapentin's effects on post-operative     pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence.     Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore     patients experience a bulge or pressure in the vagina. Patients with these conditions are     typically offered medical treatments, but some may require surgery, and this usually consists     of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any     concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to     patients undergoing urogynecologic surgery on their pain levels after surgery, including the     amount of opioid pain medication required. We hypothesize that the patients who receive     gabapentin before surgery will require significantly less opioids.      Over a six-month period, patients seen in Urogynecology clinics will be invited to     participate in the study. Women who are already on gabapentin for other reasons, have an     allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand     spoken English will be excluded from the study. After providing informed consent, they will     be randomized to either receive gabapentin or a placebo pill. They will receive the standard     surgical care, including the usual anesthesia for surgery and routine pain medications     available after surgery. We will then compare the differences in opioid consumption in the     first 24 hours after surgery as well as the time from the end of surgery to leaving to the     recovery room and the length of recovery room stay between the gabapentin and placebo groups.     We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the     patients in each group.   "
21841|NCT02999711|"     Purpose of this study is to assess the safety and tolerability of multiple ascending     subcutaneous doses of REGN3500 to moderate asthmatics.   "
21842|NCT02999698|"     The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis     suppurativa on patients, in order to compare both pathologies.   "
21843|NCT02999685|"     Regular physical activity has been found to be important in maintaining health and well-being     in people with COPD. The purpose of this study is to test new technology and health coaching     aimed to help people with COPD become more physically active in their daily lives.   "
21844|NCT02999672|"     This multicenter, non-randomized, Phase II, single agent study will assess the efficacy, and     safety of trastuzumab emtansine in participants with HER2-positive (immunohistochemistry     [IHC]3+ in greater than or equal to [>/=] 30 percent [%] of tumor cells) locally advanced or     metastatic UBC or metastatic pancreas/cholangio cancer. Participants must have received at     least one prior (for bladder cancer platinum-based) treatment for inoperable, locally     advanced or metastatic tumor. Participants will receive intravenous (IV) infusion (infusion     duration=90 minutes [mins]) of trastuzumab emtansine until unacceptable toxicity, withdrawal     of consent, disease progression (PD), or death, whichever occurs first.   "
21845|NCT02999659|"     The pupilometer determines the alteration of the pupil diameter after a defined light     stimulus. In this study data is collected from pupilometer measurements of patients with an     acute cerebral disease. The measurements take place during daily neurological routine     examinations. The values are compared to outcomes resulting from pupilometer measurements     done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without     symptoms). The study aims to establish the not invasive method of pupillometry for detecting     neurological degradations early.   "
21846|NCT02999646|"     The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1     in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead     tumor cells from the patient itself and genetically modified cells within a capsule. The     whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected     underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9     the capsules are removed again. The patients are then followed-up for 5 years.   "
21853|NCT02999555|"     A molecular study of follicular fluid aspirated from ovarian follicles during routine in     vitro fertilization treatment, after the eggs were identified and separated.   "
21854|NCT02999542|"     The researchers are conducting a research study to see whether listening to music during an     operation will have a positive effect on the way that children wake up from     surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and     screaming (known as emergence delirium). Research have shown that music decreases anxiety and     pain. The researchers want to see whether music can also influence a child's behaviour after     emerging from anaesthesia. In other words whether they will be more calm and cooperative     after listening to music while they are asleep during surgery. Should music have a positive     effect, anaesthesiologists may use it in future to improve care of patients coming for     surgery.   "
21855|NCT02999529|"     Cancer patients are presented with a lot of information about their diagnosis and different     treatment options, which can be confusing. The purpose of this study is to see if a simple     video explanation of six words used to describe cancer treatment improves patient     understanding of these words.   "
21856|NCT02999516|"     Subjects participate in a motor learning training with a special bicycle. The experimental     group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest     where they use motor imaginary. The control group proceed equal except for the motor     imaginary intervention.   "
21857|NCT02999503|"     In this study the investigators aim to investigate the relationship between environmental     factors, lifestyle and symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Initially     the investigators intend to measure the relationship between nutritional quality, exercise     and sleep and ADHD symptoms. And then measure whether a change made in the diet can improve     the symptoms of ADHD.   "
21858|NCT02999490|"     Clinical examinations are difficult to discriminate between vegetative state and minimally     conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not     been established in a clinical setting. we will do a forward study of PET imaging in     disorders of consciousness patients, and validate with clinical assessments with the coma     recovery Scale-Revised(CRS-R).   "
21859|NCT02999477|"     This research study is exploring chemotherapy in combination with immunotherapy (a therapy     that uses the body's own immune system to control cancer) as a possible treatment for hormone     receptor positive breast cancer.      The interventions involved in this study are:        -  Pembrolizumab (MK-3475; Keytruda™)        -  Nab-Paclitaxel (Abraxane   "
21860|NCT02999464|"     The purpose of this study is to compare the effects of qigong practice with fitness exercise     on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of     stroke survivors.   "
21861|NCT02999451|"     POEM is a new intervention for the treatment of achalasia and has been reported to relieve     the dysphagia symptom effectively. Although the cost of POEM method is less than the method     of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the     patients with achalasia. In this trial, investigators plan to use snare to assist POEM     procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared     with other knifes-assisted procedure.   "
21862|NCT02999438|"     Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to     decreased resistance to stressors and is associated with adverse health outcomes. The     syndrome has been well studied in adults and is quantified by the Fried criteria, which are     comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and     diminished physical activity. The concept of frailty is novel in children. A study in young     adult childhood cancer survivors demonstrated increased incidence of frailty in this     population along with increased risk of morbidity and mortality. This suggests that frailty     as a phenotype has relevance outside of the geriatric age group. Pediatric patients with     single ventricle physiology, heart failure and pulmonary artery hypertension- all represent     populations with significantly increased risk of mortality, morbidity and decreased quality     of life. Currently, such patients are monitored outpatient by serial echocardiograms and     blood work that only gives information about end organ damage. But there is no validated tool     available to measure global infirmity in such children. Better understanding of the relevance     and applicability of frailty in pediatrics may allow for identification of the most     vulnerable pediatric cardiac patients and be of value in optimizing their clinical management     and improving health outcomes.   "
21863|NCT02999425|"     The overall idea to be evaluated in this project is that educational activities providing     top-notch knowledge on diet and physical activity may represent an additional benefit to the     strategies aimed at decreasing lifestyle diseases in Serbian population of both young and     mature age. The specific objectives of this project are:        1. to develop user-friendly guidelines for physical activity and nutrition for two age          group cohorts (K-12 and adults) of Serbia residents;        2. to provide a brief educational intervention about nutrition and healthy lifestyles at          school or work settings in each age group;        3. to determine if an educational intervention would yield an additional benefit in the          acquisition of knowledge on nutrition and physical activity;        4. to promote and disseminate project results using popular media, non-professional and          professional bodies and relevant events.   "
21874|NCT02999282|"     In this randomized, double-blind, sham-controlled study, the investigators will evaluate the     effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on     neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic     stimulation (TMS), in asymptomatic subjects at risk and symptomatic patients bearing a     pathogenic Progranulin mutation.   "
21875|NCT02999269|"     Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with     depressive episodes. During a typical four-week ECT series, most depressive episodes will     respond to treatment and people will improve their level of functioning (return to work or     family). Independent of the antidepressant effect of ECT, many patients experience transient     memory impairment. This investigation will examine the impact of one ECT parameter (pulse     amplitude or current) on brain changes (structure of connections within the brain) and     clinical outcomes. The goal of this investigation is to determine the optimal parameter for     an individual patient that will maintain the clinical response (reduce depression severity)     and minimize side effects (eliminate memory issues related to treatment).   "
22596|NCT02990039|"     The purpose of this study was (i) to develop a brief counseling letter intervention aiming to     reduce sedentary time and to increase physical activity during leisure time among adults aged     42 to 64 years and (ii) to provide information on the feasibility.   "
21864|NCT02999412|"     Background: Mismanaged prescribing and use of medication among elderly puts major pressure on     current healthcare systems. Performing a medication review, a structured critical examination     of a patient's medications, during hospital stay with active follow-up into primary care     could optimise treatment benefit and minimise harm. However, a lack of high quality evidence     inhibits widespread implementation. This manuscript describes the rationale and design of a     pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.      Aim: To study the effects of hospital-initiated comprehensive medication reviews, including     active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and     2) solely hospital based reviews.      Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.      Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.      Participants: Patients aged 65 years or older, admitted to one of the study wards. Exclusion     criteria: Palliative stage; residing in other than the hospital's county; medication review     within the last 30 days; one-day admission.      Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with the     addition of active follow-up into primary care; 3, usual care.      Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up     period.      Data collection and analyses: Extraction and collection from the counties' medical record     system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using     log-linear Poisson generalized linear mixed models and frailty models.      Relevance: This study has a high potential to show a reduction in elderly patients'     morbidity, contributing to more sustainable healthcare in the long run.   "
21865|NCT02999399|"     To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism     of the polycyclic aromatic hydrocarbon deuterated phenanthrene ([D10]phe) in current and     former smokers   "
21866|NCT02999386|"     The clinical relevance of the observed stress induced hyperglycemia in trauma patients     remains unclear. The earlier studies suggested the implications of cytokines in stress     induced hyperglycemia and the outcomes after trauma. To date, there is little information     available regarding the effect of diabetic hyperglycemia (occult or known) on outcomes after     trauma and whether these patients represent a distinct group with differential outcomes when     compared to those with stress-induced hyperglycemia. Herein, the purpose of this study is to     identify the incidence of stress induced hyperglycemia as well as diabetic hyperglycemia in     trauma patients and to investigate the association between proinflammatory cytokine levels     and hyperglycemia in our trauma population.   "
21867|NCT02999373|"     About 37% of neonatal mortality are caused by infection worldwidely . Excessive application     of broad-spectrum antibiotics increased drug-resistance, however does not decrease morbility     and mortality of neonates. Based on the investigator' early in vitro experiments which found     cord blood mononuclear cells can inhibit bacterial growth and reduce of drug-resistance,     along with other studies conducted recently from other groups who have reported the     successful use of umbilical cord blood mononuclear cells in animal sepsis.The investigator     would like to investigate the effects of umbilical cord blood mononuclear cells on prevention     effect of preterm infection.   "
21868|NCT02999360|"     The purpose of the study is to determine if speech therapy can be enhanced by Aerobic     Exercise (AE). Investigators will use a single subject design to determine if aphasia therapy     result in greater gains when combined with aerobic exercise.   "
21869|NCT02999347|"     The purpose of this study is to determine the interactions between pregnancy and urinary     stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub     studies are:      Study 1:      The main aims of Study 1 are to evaluate any potential impact on urinary stress continence     after a pregnancy/delivery following MUS surgery, and to evaluate any potential differences     in continence status based on the mode of delivery for these women.      Study 2:      The aim of Study 2 is to examine how obstetric factors may affect the degree of incontinence     in women registered in The Norwegian female incontinence registry prior to surgical     treatment. In addition, we want to explore if there are obstetric risk factors predicting     failure of a MUS surgery performed after pregnancy/delivery.   "
21870|NCT02999334|"     The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe     resource and staffing shortages. The investigators adapted and piloted an evidence-based     model of group antenatal care as an innovative way to improve ANC service delivery and     increase health promotion. This pilot will be conducted in Malawi and Tanzania and will     provide data to prepare for a large randomized controlled trial to document the impacts that     group antenatal has on perinatal health outcomes. This study will ultimately inform policy     and practice aimed at improving quality of antenatal care through respectful and     woman-centered care to pregnant women.   "
21871|NCT02999321|"     Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.   "
21872|NCT02999308|"     In the past, due to economic and medical resource constraints, the hemophilia comprehensive     care in China was suboptimal. The BCH data of both retrospective and prospective studies     reveals that for 4-6y and 6-9y patients with severe hemophilia respectively: 45% and 82% of     the patients have suffered from joint bleeding, with mean AJBR of 4.18 and 4.95; and 24.2%     and 33.3% of them with AJBR>10 times, led to arthropathies and made their quality of life be     heavy affected. Now, with the development of economy and medical science in China,     prophylaxis regimens have been initiated in more and more children with hemophilia.     Considering the difference between prophylaxis regimens, the frequency of joint bleeding was     reduced significantly, the quality of life of hemophilia kids improved. An assessment scoring     system for the appropriate validation of individualized prophylaxis treatment regimens are     urgently needed.      Before, the most important assessed indication for hemophilia prophylaxis was the frequency     of joint bleeding. But increasing evidences are showing that there is a discrepancy between     real joint damage and joint bleeding frequency. The single indicator of joint bleeding     frequency is not sufficient to evaluate the joint status of hemophilia children.      Under the World Health Organization's ICF guidelines, the assessment scoring system for     selecting prophylaxis for children with hemophilia should include the tools currently     available for assessment of structure/function of the joint, patient activities and patient     participation in hemophilia healthcare. According to ICF of WHO, the most common bleeding     parts are elbows, knees and ankles, therefore the assessment of children with hemophilia     should include the evaluation of the structure, the function of these 6 Index joints, the     capacity of activities and the capacity of participation of children. These will constitute a     comprehensive hemophilia evaluation system.      In China, exploration of the optimal and individualized prophylaxis regimen is urgent, and     the comprehensive evaluation system should include joint structure and function, body's     activities and individual participation, thus may be more appropriate for the individualized     prophylaxis for Chinese children with hemophilia.   "
21873|NCT02999295|"     The main purpose of this study is to evaluate the safety and efficacy of the combination     therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable     gastric or GEJ cancer.   "
23257|NCT02981199|"     Comparison of the efficacy and safety of microtransplantation and autologous transplantation     in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed.     To identify the role of microtransplantation in the treatment of multiple myeloma.   "
21876|NCT02999256|"     The present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity     eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and     blood-based cardio-metabolic markers. Participants received both Montmorency tart cherry     juice and placebo in a random counterbalanced order for 20 days. Outcome variables were     measured immediately pre- and post-supplementation and 10 days after the onset of     supplementation. It was hypothesised that Montmorency tart cherry juice would increase fat     oxidation during exercise, reduce body fat percentage and improve cardio-metabolic markers.   "
21877|NCT02999243|"     This randomized controlled trial (RCT) evaluates whether HIV self-testing (HIVST) facilitates     sexual harm reduction and reduces HIV transmission among HIV-negative MSM in China.The     intervention group will be offered HIVST kits plus harm reduction education, and followed 9     month, while the control group will receive harm reduction educational material only.   "
21878|NCT02999230|"     This study will examine the mechanisms of action of probiotics and synbiotics for control of     oral diseases, with a particular focus on exploring new strategies for caries prevention and     treatment.   "
21879|NCT02999217|"     This 4-week prospective double blind anaemia management study evaluates the effect of     high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer     surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly     assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively.     Comparison will be based on the levels of haemoglobin, ferritin and other haematological     parameters over time and profile of clinical recovery.      The primary end point is that iron isomaltoside given postoperatively is superior to placebo     in terms of increase and stability of levels of haemoglobin and other haematological     parameters.   "
21880|NCT02999204|"     To evaluate in patients with chronic kidney disease the impact of two dosages of per os     vitamin D3 supplementation (cholecalciferol) on large arterial stiffness (evaluated non     invasively by pulse wave velocity and high-resolution echotracking system). We will also     study arterial calcification (lateral abdominal radiography and echocardiogram), arterial     remodeling (high-resolution echotracking system), endothelial function (evaluated by a     non-invasive finger biosensor device), and bone remodeling (evaluated by serum biomarkers and     bone mineral density).   "
21881|NCT02999191|"     The primary objective of this trial is to investigate the relative bioavailability of BI     1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This     assessment will be performed under fasted conditions. Furthermore, the effect of food on     relative bioavailability of the tablet formulation of BI 1467335 will be investigated.   "
21882|NCT02999178|"     The aim of the current study is to investigate the efficacy and safety of nintedanib over 52     weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as     patients who present with features of diffuse fibrosing lung disease of >10% extent on     high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms     or chest imaging have worsened despite treatment with unapproved medications used in clinical     practice to treat ILD. There is currently no efficacious treatment available for PF-ILD.     Based on its efficacy and safety in Idiopatic Pulmonary Fibrosis (IPF), it is anticipated     that Nintedanib will be a new treatment option for patients with PF-ILD.   "
21883|NCT02999165|"     The purpose of this study is to assess whether two methods of breathing support in babies     called 'Humidified High-Flow Nasal Cannula' oxygen (HHFNC) and 'nasal Continuous Positive     Airways Pressure' (nCPAP) are compatible with breastfeeding. Many babies who are premature or     unwell after birth require help with their breathing. This is often achieved by blowing a     continuous flow of air through the nose and down into the lungs in order to reduce the amount     of effort the baby needs to inflate the lungs during breathing.      Currently some centres allow babies to breastfeed whilst undergoing breathing support whilst     other centres do not in case there is an increased risk of choking or other harmful events.     In the latter case, babies are fed using a nasogastric tube (NGT) that runs from the baby's     nostrils into their stomach.      At this centre, babies are allowed to breastfeed whilst simultaneously on either HHFNC or     nCPAP. This is because the concerns over the choking risk are not evidence based. This study     aims to conclusively prove that thisfeeding protocol is safe and then to expand into other     areas of research to find out the following:        -  Whether breastfeeding during nCPAP or HHFNC leads to babies establishing full          breastfeeding sooner (and subsequently reduce the length of their stay in hospital)        -  What the effects of breastfeeding of nCPAP or HHFNC are on a baby's parents (e.g.          whether it enhances bonding)        -  If nCPAP and HHFNC have different effects on breastfeeding As part of this study the          investigators will observe stable babies on nCPAP or HHFNC during breastfeeding          episodes. The investigators will monitor the babies for signs of distress or instability          and whether they are more stable when breastfeeding is not occurring. This will be          compared to an episode where the same baby is fed by NGT to see which technique is          better.   "
21884|NCT02999152|"     The aim of this study is to confirm in humans the relevance and the kinetics of radio-induced     bio-markers in plasma and urines, previously described at the preclinical stage.   "
21885|NCT02999139|"     Participants who train at The Micheli Center for Sports Injury Prevention, will undergo     testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular     endurance. They will complete training with a certified trainer and injury prevention     specialist until their specific goals are meet. Upon completion of training, they will fill     out an injury questionnaire every three months for five to ten years.   "
21886|NCT02999126|"     The purpose of this study is to determine if a slow stepwise propofol TCI induction with     Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration     required for maintenance of the general anesthesia, with propofol and remifentanil, in adult     populations older and younger than 65 years of age.   "
21887|NCT02999113|"     To explore to what extent shared mental models (SMM) occur within the Video-Assisted     Thoracoscopic Surgery (VATS) teams in a cardiothoracic surgery setting. Additionally, to     establish whether the VATS team's SMM is associated with the surgeons' technical skills,     procedural specific times, per-operative bleeding, or patient characteristics   "
21904|NCT02998892|"     Population studies suggest that time spent in sedentary behaviors is associated with     all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of     time spent in exercise. Frequent interruptions to sedentary time are however beneficially     associated with metabolic health outcomes, even in individuals who exercise regularly. The     goal is to use integrative approach to understand the biological mechanisms that underlie     these associations in a longitudinal intervention study in overweight sedentary adults. The     investigators believe that the proposed study will provide an initial evidence base for the     health benefits of breaking up prolonged sitting with short bursts of activity. This     innovative strategy may be more effective at combating the adverse effects of sedentary     behaviors than more traditional approaches.   "
21890|NCT02999074|"     The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the     currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a     beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics     or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory     clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to     either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a     waiting list control group that will get no exercise intervention during neoadjuvant CTx     (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the     clinical-pathologic stage (CPS-EG) score, which has been shown to be a valid prognostic     factor with respect to survival after neoadjuvant CTx and is routinely assessed after breast     surgery. Further, the effects of resistance and aerobic exercise on the pathological complete     response (pCR), tolerability and compliance to CTx, physical fitness, patient reported     outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and     pain, and selected biomarkers will be investigated.      First an internal pilot phase of n=33 patients will be conducted. Upon the recruitment rate,     overall feasibility and funding, it is planned that the study thereafter will directly     continue as phase III trial (anticipated sample size n=342), possibly after some adaptions     based on the experiences gained in the pilot phase. No interim analysis or unblinding of the     pilot data is planned, so that the pilot data can be integrated in the phase III study.      A confirmation of the study hypothesis would be a strong argument for patients to engage in     exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based     guidance for patients regarding type and timing of training.   "
21891|NCT02999061|"     The purpose of the study is to determine the prevalence of dental caries in preterm birth     children aged 2-5 years in primary dentition.   "
21892|NCT02999048|"     The purpose of this study is to determine whether panax notoginseng saponins are effective in     the treatment of Hypertensive Intracerebral Hemorrhage Patients.   "
21893|NCT02999035|"     A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular     surface sensitivity by employing a liquid jet.      This study aims to validate this new prototype by means of correlating its measurement with a     previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by Murphy     et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.   "
21894|NCT02999022|"     This is a study designed to see if a low dose of Lithium treatment, taken for 2 weeks, can     improve fracture healing and improve patients' function and productivity.   "
21895|NCT02999009|"     The purpose of this study is to review the performance and success rate of an FDA approved     cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study     will specifically look at the need to revise the hip replacement after 5 years. This will be     compared to how much this happens in patients who have hip replacement with similar     cementless acetabular shells.   "
21896|NCT02998996|"     The main purpose of the this study is to evaluate the safety and tolerability of Immunose™     FLU based on Endocine™ and quadrivalent influenza antigen.   "
21897|NCT02998983|"     This clinical trial will be carried out in children diagnosed with high-risk neuroblastoma     that have achieved a complete or very good partial response after standard therapy. An     additional cohort of children who could not achieve these response criteria or that relapsed     after standard therapy but do not have progressive disease will receive Racotumomab together     with metronomic chemotherapy.      The main objectives of this study are to determine the immune response after one-year     duration immunization with Racotumomab, to describe the response of Racotumomab therapy in     minimal residual disease (MRD) in bone marrow and to describe the toxicity profile of     Racotumomab.   "
21898|NCT02998970|"     The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure,     function and circulating biomarkers in patients with Type II diabetes. Empagliflozin     (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type     II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a     previous post-marketing clinical trial. The use of empagliflozin to treat patients with     diabetes and heart disease has been approved by Health Canada. However, the process by which     it may give this beneficial effect remains unclear and needs further investigation.     Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic     basis by which Empagliflozin could provide its potential cardio-protective effects by     employing the use of Cardiac Magnetic Resonance Imaging (CMRI).   "
21899|NCT02998957|"     Introduction:      Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little     bitterness reversible airflow causing shortness of breath, chronic cough and sputum abnormal.     Patients with COPD often suffer exacerbations of their symptoms, particularly dyspnea,     causing hospital admissions. Recent studies have shown that acupuncture stimulation     transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with     COPD.      Objective:      The aim of this study was to evaluate the possible utility of adding to the usual treatment     stimulation AcuTENS in COPD patients admitted with severe dyspnea.      Methodology:      Patients who agree to participate will be randomly divided into two groups. The intervention     group will receive a daily treatment, during the period of hospitalization, 45 minutes     stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group performed     the same procedure with a device TENS simulated. The extent of dyspnea in both groups as well     as the number of days of hospitalization and the number of drugs consumed.   "
21900|NCT02998944|"     This study aimed to explore the associations between constitutions of traditional Chinese     medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study     was performed to investigate the associations. A total of 3748 participants were available     for analysis in this study. The assessment of constitution of TCM was based on     recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD     was based on self-reported medical history. The associations were analyzed using univariate     and multivariable logistic regression (MLR).   "
21901|NCT02998931|"     Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill     patients, possibly in part through an attenuation of the proinflammatory cytokine response     and a Immune function. In this trial intensive care unit patients with enteral feeding will     receive either enteral glutamine or maltodextrin as placebo for 28 days.   "
21902|NCT02998918|"     Polyphenol supplements, including curcumin and resveratrol, are known to decrease     inflammation, but previous polyphenol supplements were poorly absorbed and thus their effects     were reduced. A new phytosome formulation coats the supplements and allows them to be better     absorbed. The purpose of this study is to examine the acute (1-hr) and short-term (1-week)     effects of two different phytosome-formulated polyphenol supplements on inflammation. The two     supplements that will be used are: 1) PolyResveratrol and 2) Curcumin.   "
21909|NCT02998827|"     The effectiveness of thalidomide in treating inflammatory bowel disease has been widely     recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on     ovarian reserve function.Therefore, this study was to investigate the influence of     thalidomide on function of ovarian reserve.   "
21910|NCT02998814|"     The purpose of this study was to evaluate the retention rates of a fissure sealant placed     using different adhesive protocols over 24 months.Twenty-four subjects with no restoration     and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different     adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants     were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse     adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with     acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a     table of random numbers. Two other calibrated examiners, independently evaluated the sealants     at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of     caries formation being present or absent and retention using the following criteria:     1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to     evaluate differences in retention rates among the sealants for each evaluation period.   "
21911|NCT02998801|"     To construct and evaluate an immersive 3D simulation to familiarize patients with the     pre-operative experience, and investigate whether A) immersive 3D virtual reality video can     reduce pre-operative anxiety, and B) how this approach compares to current practice of     viewing traditional educational videos.   "
21912|NCT02998788|"     This is an prospective study conducted in a Chinese heart failure population. The study     investigates the effects of cardiovascular disease risk factors such as lifestyle     behaviors,biomarkers and intermediate diseases on heart failure prognosis.   "
21913|NCT02998775|"     E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or     severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy     participants. The primary objective of the study is to obtain plasma from participants for     use in in vitro protein binding studies.   "
21914|NCT02998762|"     The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND study     population of patients every six months and continuing over a five-year period. This will     provide information on the longitudinal progress in mood, functioning, and quality of life of     the CAN-BIND sample with a view towards long-term outcome and treatment.   "
21915|NCT02998749|"     The aim of our retrospective clinical study was to examine the association between agonal     breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim     was to examine role of basic life support (BLS) and response time. Our hypothesis is that     agonal breathing has positive effects on both primary and secondary endpoints.   "
21916|NCT02998736|"     The purpose of this study is to determine if giving Cialis for 5 days prior to surgery, on     the day of surgery along with the influenza vaccine and Cialis 10 days after surgery will     have an affect at the cell level for decreasing the chances of the spread of disease post     surgery.   "
21917|NCT02998723|"     Attrition of skills after basic life support (BLS) training is common. Psychology studies     have established that for basic memory recall tasks, spaced learning strategies improve     retention. Spaced learning is often organized as a refresher or 'booster' course after     initial training. This study aims to investigate if this principle holds true for BLS skills,     which require rapid memory recall and efficient deployment of procedural skills while under     time pressure.   "
21918|NCT02998710|"     The purpose of the study is to characterize the clinical course of Cystathionine     Beta-synthase Deficiency Homocystinuria (CBSDH) in pediatric and adult patients under current     clinical management practices   "
21919|NCT02998697|"     The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in     improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia     (IDA).   "
21920|NCT02998684|"     This study will examine whether brain stimulation paired with social skills learning can help     teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance     learning in some people. This study involves enrolling in a 14-week training program where     teenage boys with autism interact in small groups and learn social skills. During the 14-week     program participants will receive active brain stimulation, or non-active stimulation     (placebo). Before and after this training, MRI scans will be taken to see whether the     training with active brain stimulation made a different in brain activation.   "
21921|NCT02998671|"     The study is designed primarily to assess preliminary efficacy and safety of CJM112 in     patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate     clinical profile for further clinical development. In addition, sustainability of response     and dose relationship will be explored.   "
21923|NCT02998645|"     This is a two-part study, interventional Phase II, single-arm, multicenter, open-label study     to investigate the efficacy and safety of a combination regimen of eltrombopag and     cyclosporine in patients with severe aplastic anemia (SAA) as first line therapy and an     extension with up to 60-months follow-up. All patients will receive eltrombopag for 6 months     with cyclosporine. Patients who respond (who had overall hematologic response by 6 months)     will continue tapering down cyclosporine for up to 30 months and will be followed up for a     post-treatment follow-up up to 60 months by regular clinic visits. Patients who do not have     an overall hematologic response (non-responders) by the end of 6 month time point will be     discontinued from the treatment and will be followed up for non-responder post-treatment     follow-up up to 60 months The usage of eltrombopag and cyclosporine combines two therapies     with different modes of action. Cyclosporine acts as an immunosuppressant and eltrombopag     acts as a stimulator of bone marrow progenitor cells. Given that SAA is currently viewed as     having an autoimmune pathogenesis resulting in bone marrow progenitor cell destruction, the     combination of eltrombopag and cyclosporine is attractive. Preliminary experience with their     combined use appears favorable, with no untoward toxicity observed to date.   "
22079|NCT02996617|"     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor     to limit the dosage and the continuation of chemotherapy. The PEG-rhG-CSF has increased     plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study     is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia     following chemotherapy in patients with non-Hodgkin lymphoma.   "
21924|NCT02998632|"     -  Patients will be diagnosed to determine whether they are eligible for the inclusion          criteria of this study or not. Patients who are eligible will start their surgical          treatment in the next visit after radiographic and surgical site evaluation.        -  On the day of surgery, each patient will be assigned to either intervention or control          group, the patients will receive inferior alveolar nerve block and long buccal nerve          anesthesia. Future implant site will be planned, an incision will be made and flap will          be reflected along the defective ridge.        -  Implant fixture/s will be inserted in the previously planned site. Uncovered fixture          threads and bone defect will be covered by MPM or autogenous bone graft.        -  In the control group, autogenous particulate bone graft will be used for vertical          augmentation and covered with titanium reinforced membrane. In the intervention group,          MPM (Mineralized plasmatic matrix) will be used.        -  Edges will be approximated, Sutures will be placed.        -  Osstell instrument will be used to measure and record fixture primary stability in ISQ          units.        -  Patients will be referred to the fixed prosthodontics department for placement of the          crowns after ensuring success of osseointegration and implant stability (after 4          months).        -  Patients will evaluate their overall satisfaction after fitting the final prosthesis          using a questionnaire at 9 months.        -  After 9 months, CBCT will be performed to evaluate augmented bone height to be compared          with the bone height previously recorded in CBCT.        -  Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to          be compared to the ratio recorded before.   "
21925|NCT02998619|"     Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal     vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010     and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as     well as toxicity according to CTCAE v4.03.   "
21926|NCT02998606|"     To date, few studies have assessed the effect of opioids on esophageal motility, mostly     assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a     large retrospective study assessing the effect of opioids on esophageal motility found that     esophageal motor dysfunction are common in chronic opioid users whether studied on opioids     and off opioids. In addition, current opioid users also had significantly higher integrated     relaxation pressure and manometric patterns consistent with type III achalasia. (Ratuapli     2015) Peripherally acting mu opioid receptor antagonists (PAMORA) appear to be useful to     reduce the peripheral effects of mu opioid receptor agonists to delay gastrointestinal     transit without affecting the centrally mediated analgesic effects. MOVANTIK™ (Naloxegol) is     the first oral peripherally acting mu opioid receptor antagonists for opioid-induced     constipation. MOVANTIK™ (Naloxegol) has been recently approved for opioid-induced     constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose,     MOVANTIK™ (Naloxegol) is effective and safe, with a limited side effect profile and is     associated with preservation of centrally mediated analgesia.      This study will explore the safety and tolerability of MOVANTIK™ (Naloxegol) in this patient     population.      The investigational hypothesis is that MOVANTIK™ (Naloxegol) could improve opioid- induced     esophageal motility disorders   "
21927|NCT02998593|"     This study is a prospective double blind randomized controlled trial to investigate the     effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation     in idiopathic oligospermic men .Include patients will take the medicine and placebo in     different two case and control groups for 3 month and semen parameters and other variants at     the start and end of study.   "
21928|NCT02998580|"     This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst     stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site of     stimulation in both treatment conditions. The site of stimulation will be targeted using MRI     co-registration. The study seeks to determine if the bilateral theta burst protocol has     similar effectiveness to the conventional bilateral rTMS protocol in treating major     depression.   "
21929|NCT02998567|"     HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110) a Second     Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with     Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of     the combination.   "
21930|NCT02998554|"     The purpose of this study is to determine if an investigational treatment is effective     compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.   "
21931|NCT02998541|"     The purpose of this study is to determine if an investigational treatment is effective     compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral     conjunctivitis.   "
21932|NCT02998528|"     The purpose of this study is to determine the safety and effectiveness of nivolumab and     ipilimumab compared to chemotherapy in the treatment of Early Stage Non-Small Cell Lung     Cancer.   "
21958|NCT02998190|"     The purpose of this study is to determine the safety profile of single and multiple doses of     EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and     multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018     on the healthy male gut microbiome.   "
21933|NCT02998515|"     Taken recent literature together, there is a sufficient number of trials investigating the     effect of different oxygen devices. However, studies comparing oxygen delivery via portable     oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing     and sufficient power are missing.      Given that walking is the most important activity of daily life to preserve the maintenance     and to participate in social life, we aim to investigate the effects of two different oxygen     delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).      The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking     capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT     is that the ESWT is performed at 85% of the individual maximum which is close to the     intensity of typical daily activities. Due to the fact that the ESWT enables us to determine     the maximum duration of exercise and to compare values at isotime (at the point of time when     the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.   "
21934|NCT02998502|"     This study will test the efficiency of the Freespira Breathing System in youth.   "
21937|NCT02998463|"     This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by     mother-infant dyads. It has three phases including researcher observation, randomised     controlled trialing and qualitative midwifery staff perspective. The research will determine     the effect a facilitating garment has in comparison to conventionally facilitated     skin-to-skin contact, by measuring its effect on the baby's temperature stability,     breastfeeding status and weight velocity.   "
21938|NCT02998450|"     The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled     study is to evaluate the safety, tolerability, PK and PD profile of the orally administered     IMR-687 in healthy adult subjects.   "
21939|NCT02998437|"     This study evaluate the pharmacokinetic drug interaction in Ilaprazole, Clarithromycin,     Amoxicillin.   "
21940|NCT02998424|"     Resting pupillary diameter was measured at a randomized Effect-site target concentration of     propofol used as a sole anesthetic.   "
21941|NCT02998411|"     In case of sepsis, the therapeutic success is strongly influenced by the choice of     anti-infectives (AI) in terms of spectrum, dosage and administration schedule. It is     therefore critical to achieve adequate AI concentration as quickly as possible.      This protocol aims to define a common framework to studies conducted jointly by the     Antimicrobial Stewardship Team and the Pharmacology department of Cochin hospital for various     AI in a range of specific study populations (intensive care unit patients, neutropenic     patients…).      These studies will use mathematical modeling methodologies to investigate the     pharmacokinetics (PK) and pharmacodynamics (PD) of different AI including PK/PD targets. The     effects of covariates on PK and PD parameters will be investigated to better explain the     between-subject variability (BSV) and to ultimately suggest individualized dosage regimens.   "
21942|NCT02998398|"     The purpose of this study is to evaluate the effectiveness of the switch from the original     infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital     receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition   "
21943|NCT02998385|"     A phase III, multicenter, randomized, open-label, french study comparing:        -  Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction)        -  Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) +          concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)   "
21944|NCT02998372|"     Computational simulation will be performed to represent motion of knees with a dislocating     kneecap. Common surgical treatment methods will be simulated and anatomical parameters     commonly associated with the dislocation will be varied in order to characterize the most     appropriate surgical approach as a function of knee anatomy.   "
21945|NCT02998359|"     In England each year over 9,000 people fracture their hip. Most of these are elderly females     with the fracture occurring after a fall. Approximately half of these fractures are     classified as intracapsular fractures because of their close proximity to the hip joint. The     majority of these fractures are treated surgically by excising the broken femoral neck and     removing the femoral head (ball part of the hip joint) and replacing it with an artificial     hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed     a 'half hip replacement' in which only the ball part of the hip joint is replaced.      An alternative type of hip replacement is the full total hip replacement in which the socket     part of the joint is also replaced. This is the operation that is used for replacing     arthritic hips. In recent years there have been a number of randomised trials that have     compared the outcome for patients with an intracapsular hip fracture treated with either a     partial hip replacement (hemiarthroplasty) against those treated with a total hip replacement     (THR). Results to date have suggested slightly better long term functional results for those     treated with a THR, but it still remains unclear if these benefits are offset by the     increased surgical complexity of the procedure and the extra cost involved for a THR.      At present the numbers of studies on this topic are too few with limited patient numbers to     make any definite conclusions. This study aims to add to the research studies by comparing     the two surgical procedures, to enable orthopaedic surgeons to determine the optimum surgical     treatment for this common and disabling condition.   "
21946|NCT02998346|"     The purpose of this observational study is to measure the number of calories delivered from     fluids used in continuous renal replacement therapy (CRRT). We are doing this research study     because the fluids used in this treatment may deliver an important number of calories. In the     future this could help better estimate how much nutrition patients in the Critical Care Unit     should get every day from other sources like tube feeding or nutrition through a person's     veins.   "
21971|NCT02998021|"     The primary purpose of this study is to explore the benefits of vibration dumbbell resistance     training over standard dumbbell resistance training for improving upper limb strength,     function and pain among manual wheelchair users with paraplegia.   "
21947|NCT02998333|"     Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of     patients with lateral ankle ligament injuries, chronic lateral ankle instability may be     present. If conservative treatment fails, instability is treated surgically. Anatomic repair     (also known as the Bröstrom procedure) is the current golden standard for surgical treatment     of chronic ankle instability. The Bröstrom started out as an open technique and is now also     performed arthroscopically. Both approaches are considered standard care and provide good     results. Which approach is best, has not yet been researched. In this study it is     hypothesized arthroscopic repair provides better functional outcome compared to open repair     during short term follow-up.      Objective: The main objective of this study is to compare the functional outcome after     arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and     secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and     open ligament repair.      Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All     patients willing to participate, from an age of 18 years old, with persisting ankle     instability for at least 6 months, eligible for anatomic repair.      Intervention: Both groups of patients are surgically treated with anatomic repair of the     anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by     the open approach.      Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months     after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a     difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important     Change = 10 points; 2 per subscale).   "
21949|NCT02998307|"     Objectives: The primary objective is to determine the least frequent CPR training interval     associated with continued performance of guideline-compliant CPR. The secondary objective is     to determine whether certain physical characteristics, such as age, gender, exercise     tolerance, height, and weight may be able to identify HCPs at high risk of being unable to     perform high-quality CPR.      Design: Randomized trial to compare the effect of different training frequencies on long-term     CPR performance.      Participants and setting: Nurses in all adult departments at Health Sciences North. Subjects     will be randomly assigned to a group that undertakes short CPR assessment and training     sessions either 1) every month, 2) every 3 months, 3) every 6 months, or 4) every 12 months     (control group) over the course of a twelve-month period.      Analysis: The proportion of nurses in each group that is able to perform excellent CPR at     the twelve-month time point will be determined. Excellent CPR is defined as a two-minute CPR     session where 90% of compressions are performed with correct depth (50-60 mm), 90% with     correct rate (100-120 /min), and 90% with full chest recoil. A subgroup analysis will also be     performed where the demographic data of individuals who are unable to perform excellent CPR     at the twelve-month time point regardless of intervention group are compared against those     who are successful.      Conclusion: The results of our study will help determine the longest CPR training interval     associated with maintenance of high-quality CPR skills to minimize training sessions required     and decrease associated costs. The results will also generate hypotheses for future study     about optimizing role assignments and team performance in resuscitation.   "
21950|NCT02998294|"     The purpose of this study was to determine the accuracy of one-time respiratory volume     measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume     measured by mechanical ventilation in post-operative ICU patients.   "
21951|NCT02998281|"     Even if cerebral palsy not directly effect respiratory system, impairment of nervous and     muscle systems, because of the brain damage, may cause respiratory functions impairment. In     literature, it has been showed that children with cerebral palsy have decreased respiratory     muscle strength and associated with trunk control, quality of life and respiratory functions.     But, there is no study in literature that aims to increase respiratory muscle strength in     these children. Hence, the aim of this study is to investigate effects of inspiratory muscle     training on respiratory functions, trunk control, activities of daily living, functional     exercise capacity and quality of life in children with cerebral palsy.   "
21952|NCT02998268|"     This is a randomized, multicenter phase II study of pembrolizumab in combination with     chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the     safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation     in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival     rate.   "
21953|NCT02998255|"     Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines     recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the     high-volume PEG still results in lower compliance to the regime and increased cost.      Some high risk factors for inadequate BP have been identified, including old age,     constipation, diabetes, the use of narcotics and prior history of inadequate BP. For     average-risk patients without the high risk factors, the procedure of BP could be easier. In     the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk     patients achieved adequate BP. Here investigators hypothesized that compared with the     standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while     may be accompanied with better tolerability.   "
21954|NCT02998242|"     To study safety and efficacy of apatinib in combination of radiotherapy in patients with     symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor     activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).   "
21955|NCT02998229|"     The purpose of this study is to assess the safety and effectiveness of the Artisse™     Intrasaccular Device in the treatment of bifurcating saccular intracranial aneurysms.   "
21956|NCT02998216|"     This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after     bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.   "
21957|NCT02998203|"     The study aims to evaluate the hypothesized benefits of a systematic organic diet for     children, over those of a conventional diet. The specific objectives of this study are to: i)     Demonstrate the decreased body burden of pesticides for those children consuming an organic     diet, and ii) Evaluate the effects in specific biomarkers of inflammation and oxidative     stress in children systematically consuming an organic diet.   "
21959|NCT02998177|"     The objective of this study is to determine the association between gut microbiome diversity     and the characteristics of rebound pain at offset of peripheral nerve block in patients who     have undergone upper limb surgery. Other purposes of this study are to determine associations     between gut microbiome constitution and persistent post-surgical pain; and describing rebound     pain by quantifying its clinical, psychological and neurophysiological characteristics in     this patient cohort.   "
21960|NCT02998164|"     This study evaluates the efficacy of using augmentative and alternative communication (AAC)     technology for enhancing language development in children who are deaf or hard of hearing.     Half of the participants will receive AAC technology with their speech and language therapy     and half will continue with their usual care models.   "
21961|NCT02998151|"     The aim of this study is to utilize neurophysiologic assessments, behavioral measures and     clinical measures to assess how much deficits associated with Fragile X Syndrome from     pre-dose to post-dose Acamprosate, lovastatin, minocycline and placebo.   "
21962|NCT02998138|"     This will be an open label, prospective study to determine the association between specific     genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain     perception, postoperative pain, analgesic and side effect responses to perioperative opioids,     chronic postoperative pain and gene expression in adolescents following major spine surgery.   "
22080|NCT02996604|"     He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination     with synergistic effect for functional dyspepsia(FD). The investigators design the trial to     identify the efficacy and explore the central integrated mechanism of puncturing at     He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).   "
21963|NCT02998125|"     The intention is to explore whether there are factors, which can help us to understand why     some patient outcomes, following total knee arthroplasty are not successful and identify     prediction factors for progression. Assessment of outcomes pre- and post-surgery with     objective tools is a way to explore prediction tools for good/poor progression and improve     patient selection and timing for surgery.      The first aim of this project is determine the psychometric properties of the Arabic Version     of Oxford Knee Score, including internal consistency, reliability and validity before and     post-total knee arthroplasty in both males and females in a Middle East population. The     second aim is to assess the reliability of the Star Excursion Balance Test for measuring the     dynamic balance. The final aim is explore outcomes post-total knee arthroplasty among Middle     East patients using the Arabic Version of Oxford Knee Score, physical activity measures and     performance-based measurements such as: 30 s chair-stand test, stair-climb test, timed     up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society     International recommendations.   "
21964|NCT02998112|"     To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of     Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial     to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the     efficacy and safety of FMT for patients with moderate or severe UC.   "
21965|NCT02998099|"     The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of     IV rivipansel.   "
21966|NCT02998086|"     Parenting a child with cancer is highly stressful. The investigators have designed a     promising parent-centered intervention to bolster parent resilience and reduce stress and     distress. This study will test 2 formats of the intervention (individual or group-based) and     compare them to usual care.   "
21967|NCT02998073|"     This research focuses on justice-involved youth with conduct disorder (CD) and a history of     violence. CD is a youth-limited neurodevelopmental disorder that is commonly associated with     criminality. Although psychosocial interventions that address impulsivity and self-control     have been shown to be effective at helping promote prosocial behavior in patients with CD,     the biological changes that occur as a result of treatment are not well understood. This     study will explore changes in cortisol (a stress hormone) and the brain function of the     anterior cingulate cortex (ACC) in response to a common psychosocial intervention (Stop, Now     and Plan Youth Justice Model). This study will contribute to our understanding of biological     mechanisms involved in therapeutic gains among youth offenders and thereby inform further     development of treatment programs for justice-involved youth.   "
21968|NCT02998060|"     Computer-based navigation systems were first introduced to spine surgery in 1995 and while     they have been long established as standards in certain cranial procedures, they have not     been similarly adopted in spine surgery. Designed to overcome some of the limitations of     navigation-based technologies, robot-guided surgical systems have become commercially     available to surgeons worldwide.These systems are rapidly challenging the gold standards.      The aim is to conduct a prospective randomized controlled trial. The randomized variable will     be the screw placement technique used. One arm will be treated with lumbar fusion using     robotic guidance (RG), one arm will receive the same procedure but with a free hand technique     (FH) and the third arm will use navigation (NV) (CT or Fluoroscopy-assisted). Intraoperative     screw revisions and revision surgery for screw malposition as well as clinical     patient-reported outcomes to identify any such differences between these methods of screw     insertion will be assessed.   "
21970|NCT02998034|"     In England each year over 9,000 people fracture their hip. Most of these are elderly females     with the fracture occurring after a fall. Approximately half of these fractures are     classified as intracapsular fractures because of their close proximity to the hip joint. The     majority of these fractures are treated surgically by excising the broken femoral neck and     removing the femoral head (ball part of the hip joint) and replacing it with an artificial     hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed     a 'half hip replacement' in which only the ball part of the hip joint is replaced.      There are a number of different designs of hemiarthroplasty that may be used. Some of the     implants are fixed in place with bone cement whilst the rest are inserted as a press fit     without the bone cement. The early designs of implant were all press fit but these designs     have now been shown to be inferior to those implants that are fixed in place with bone     cement.      There are however a number of newer designs of implant that are coated with a substance     (hydroxyapatite) that encourage the bone to grow onto the implant to fix it into place. To     date these implants have only been compared to the cement fit implants in only one previous     study. This study found no notable difference between the two types of hemiarthroplasty. This     study aims to add to the research studies by comparing standard cement fit implant with a     hydroxyapatite coated press fit implant to assist in determining the optimum surgical     treatment for this common and disabling condition.      Both implants to be used in this study are still being used extensively within the United     Kingdom and worldwide to treat this fracture. The study is therefore using two different     implants within their recommended area of use, but in which there is uncertainty as to which     is the best implant.   "
21972|NCT02998008|"     It is known from research that long-term exercise exposure in type 2 diabetes had positive     effects. However, the effect of acute exercise in a patient group with already reduced     cardiac function is not known.      In this study, the impact of acute exhaustive high intensity interval training on cardiac     function will be investigated in type 2 diabetes patients.      One single session of exhaustive high intensity interval exercise training is expected to     lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the     right ventricle of the heart is expected to be more affected than the left ventricle.   "
21973|NCT02997995|"     This is an open-label, multicentric, international, phase II trial testing aromatase     inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10%     CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment     will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+     patients will receive 6 months of durvalumab combined with exemestane.   "
21974|NCT02997982|"     This study investigates the effects of Valaciclovir treatment to individuals with Alzheimer's     disease or Mild Cognitive Impairment of Alzheimer's Disease Type. It is an open pilot trial     where 36 participants will receive 4 weeks of Valaciclovir treatment. Participants will be     investigated using different measures before and after the treatment period.   "
21975|NCT02997969|"     The purpose of this study is to evaluate the safety and immune response to an HIV clade C DNA     vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.   "
21976|NCT02997956|"     This is a phase IB study design planned to identify the MTD (Maximum Tolerated Dose) of     Tocilizumab in HCC (Hepatocellular Carcinoma) patients followed by a phase II design     whereupon the primary objective will be median progression free survival (PFS).   "
21977|NCT02997943|"     The overall objective of this study is to use an innovative experimental approach, the SMART     (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the     delivery of mHealth tools and traditional treatment components in a stepped program of     obesity treatments. The SMART approach is a highly efficient strategy for identifying and     constructing efficacious adaptive interventions: it accommodates sequential decision-making     based on the participant's response to early weight loss treatment components. The proposed     treatment package begins with the least expensive components, and for participants identified     as treatment non-responders, provides sequential step-up of additional treatment components.     By sequentially delivering treatment components based on participant response, SMART permits     achievement of the target outcome, weight loss, with least resource consumption and     participant burden.   "
21978|NCT02997930|"     The long-term goal of this study is to evaluate cognitive function preoperatively and develop     techniques of intervention in the perioperative period which would optimize brain function     and functional recovery following surgery.   "
21979|NCT02997917|"     The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low     temperature and 25 g bread) will be studied in a parallel design. The effects of education     will be tested in two different groups in random order: real versus sham education. In each     group the responses to a probe meal will be tested on 2 different days before and after the     intervention. Participants will be instructed to eat a standard dinner the day before, to     consume a standard breakfast at home after overnight fast, and to report to the laboratory,     where the probe meal will be administered 3 h after breakfast. Studies will be conducted in a     quiet, isolated room with participants sitting on a chair. Perception will be measured at 5     min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min     after the probe meal.   "
21980|NCT02997904|"     A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically     superior to a sham control with one hour of combing.   "
21981|NCT02997891|"     The purpose of this study is to investigate the effectiveness of a hip arthroplasty for     chronic pain, caused by a unilateral primary Coxartrhrose, regarding the cognitive     performance. It is based on the hypothesis that the combination of chronic pain along with     relative immobilization causes impairment of cognitive performance. The total hip replacement     reduces pain, increases the mobility level and finally improves the cognitive performance.   "
21982|NCT02997878|"     MERLIN is an adaptive, single arm, multi-centre, phase IIa multi-disease clinical trial. It     is designed to:      i) Determine dose safety of ORBCEL-C (selected Mesenchymal stromal cells derived from human     umbilical cord) ii) Evaluate treatment activity through assessment of biomarkers      This trial has two main stages:        -  Stage 1 will determine the maximum tolerated dose that can be administered by observing          for occurrence of dose limiting toxicity (DLT).        -  Stage 2 will use the maximum tolerated dose found in stage 1 to and further determine          safety and activity outcomes of ORBCEL-C.      Upon completion of this trial we hope to be able to justify and conduct separate, larger     scale trials using ORBCEL-C.   "
21983|NCT02997865|"     This study evaluates stepped care for depression in patients with heart failure (HF). The     stepped care intervention includes cognitive behavior therapy (CBT), plus antidepressant     medication when indicated. Half of the participants will receive stepped care and half will     receive usual care for depression; all participants will receive heart failure self-care     education and support. The primary aims are to determine whether stepped care is superior to     usual care for depression, and whether treating depression improves heart failure self-care     outcomes.   "
21984|NCT02997852|"     The purpose of this study is to assess the preliminary efficacy of a 10-minute therapy dog     visitation (TDV) in reducing biobehavioral stress responses.   "
21985|NCT02997839|"     The role of sleep in patients admitted to the intensive care unit is an emerging field of     research. There have been studies that show patients in the ICU have poor sleep including     sleep fragmentation, multiple arousals, decreased stage 3 sleep and reduced REM sleep (1, 2,     3). Causes of poor sleep in the ICU include severity of illness, abnormal light exposure, and     frequent arousals for medical care. Not only does poor sleep contribute to reduced cognitive     function and delirium, but there are also implications for the immune system function and     wound healing (4). Polysomnography is regarded as the gold standard for sleep studies,     however it has limited utility in the ICU population (5) and alternative methods of sleep     analysis need to be investigated to better understand the underlying physiologic mechanisms     and subsequent cognitive effects.   "
21986|NCT02997826|"     From birth to 5 months, milk is the essential and unique food of the newborn. The French     National Nutrition Program (PNNS) recommends exclusive breastfeeding up to 6 months and at     least 4 months for a healthy benefit. However, only 36% of infants 0-6 months of age are     exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in     the first few months of life. This decision may be a personal choice or be imposed by     pathophysiological situations.      The nutritional requirements of the infant are specific, which implies adequate nutrition.     Infant formulas and follow-up formulas are therefore complex products, specially developed     for a group of vulnerable consumers. In fact, the compositional and information requirements     for infant formula are highly regulated.      Even clinical studies are not required to market an infant formula, it is important to obtain     objective date on infant growth. Therefore, this study proposes to evaluate the effect of the     consumption of an infant formula on the growth of infants from 0 to 6 months in comparison     with the growth curves of the World Health Organization (WHO).   "
22039|NCT02997137|"     Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout.     These conditions are associated with a deficiency of specific amino acids and micronutrients     that cause endocrine-cardiometabolic abnormalities. These people have specific     medically-determined nutrient requirements.      Aim of this study is to demonstrate, that the daily oral administration of a specific amino     acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex,     magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly     decrease the perceived chronic distress and associated chronic exhaustion conditions of women     and men after 8 and 12 weeks.   "
24602|NCT02963649|"     To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus     conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with     chronic total occlusions in the infrapopliteal arteries.   "
21987|NCT02997813|"     This is a retrospective observational cohort database analysis. The study will review     retrospectively the records of patients undergoing a first peripheral blood stem cell     mobilization for multiple myeloma in the databases from approximately 15 hospitals which are     part of the IFM collaborative group. Patient records will be divided into two groups of 50     patients minimum, maximum 100 patients or up to the number of patient records that could be     extracted. The first group of patients will have received plerixafor plus G-CSF without the     administration of chemotherapy as a mobilization strategy and a second group of patients will     have received cyclophosphamide plus G-CSF as a mobilization strategy.      All consecutive patients with complete set of data (and who underwent apheresis) treated     between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete     data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and     cyclophosphamide will be included.      All data that will be analyzed will be extracted from the selected IFM institutions which are     located in France.   "
21988|NCT02997800|"     Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain.     Opioids however have many unpleasant side effects including nausea and vomiting, itching,     sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood     pressure are often attributed to pain. It has been shown that by treating these changes with     medications such as esmolol, instead of opioids, side effects and time to discharge from     hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have     advantages over it. It is more effective at controlling both heart rate and blood pressure     and it is easier and less costly to use. This study is investigating labetalol in patients     having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients     will be treated with one of these drugs during surgery to control heart rate and blood     pressure and the effects on time to discharge, pain scores, frequency of side effects, and     narcotic requirements will be observed in the recovery room. It is thought that labetalol     will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will     show reduced time to discharge, fewer side effects, and effective treatment of heart rate and     blood pressure.   "
21989|NCT02997787|"     Both pelvic masses and preoperative diagnosis of them have still continued as an important     investigation subject. It is important to discriminate the diagnoses of leiomyoma and     adenomyosis before operation especially among infertile patients. Neoplasms can alter     systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio     (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete     blood counter test (CBC). A high NLR has been shown in systemic inflammation, some     gynecologic and gastrointestinal cancers and some cardiovascular diseases.      The investigators aim to investigate using new inflammation markers, NLR and PLR, whether     they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there     have been no previous reports about the association among NLR, PLR, adenomyosis and     leiomyoma.   "
21990|NCT02997774|"     Having hemodialysis affects the blood supply to various organs in the body including the     heart and the brain. With time, these effects build up and can affect the way these organs     function. The investigators have previously shown that the liver (a key organ which works to     help clean the blood, make proteins and turn all your food into energy) is also affected. One     of the ways to help protect organs from injury due to dialysis has been cooling during     dialysis. The investigators want to examine whether cooling during dialysis protects the     blood supply to the liver. CT imaging will be used to measure this blood supply during     hemodialysis with standard and cooler settings.   "
21991|NCT02997761|"     This phase II trial studies how well ibrutinib and blinatumomab work in treating patients     with B acute lymphoblastic leukemia that has come back or is not responding to treatment.     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer     cells to grow and spread. Giving ibrutinib and blinatumomab may work better in treating     patients with relapsed or refractory B acute lymphoblastic leukemia.   "
21992|NCT02997748|"     Acute kidney injury (AKI) is a well-recognized complication after cardiac surgery with     cardiopulmonary bypass (CPB). The aim of this study is to reduce the incidence of AKI by     implementing remote ischemic preconditioning and to evaluate the dose-response relationship     using the biomarkers urinary [TIMP-2] *[IGFBP7] in high risk patients undergoing cardiac     surgery.   "
21993|NCT02997735|"     Secondhand smoke (SHS) exposure is a significant public health problem in that it both harms     children and is widely prevalent, affecting more than 40% of US children. Tobacco cessation     quitlines are effective in helping smokers quit, but few smokers make use of their services.     Electronic health record-based systems that automate referral of interested parents to     quitlines through pediatric settings may increase the proportion of smokers who successfully     enroll in treatment.   "
22013|NCT02997475|"     The purpose of this study is to investigate areas of the brain responsible for     self-regulation in adult women who have never had an eating disorder with women who have     bulimia nervosa. More specifically, investigators are interested in changes in brain     activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and     regulating emotions. Data collection will rely on a technology called functional magnetic     resonance imaging (fMRI).   "
21994|NCT02997722|"     Patients admitted to the University of Mississippi's inpatient psychiatry unit for suicidal     ideations will be given the opportunity to participate in the study. Within 24 hours of     arriving to the inpatient psychiatric floor, patients who choose to participate will be     randomized to receive either a placebo saline infusion or a ketamine infusion of 0.5 mg/kg     over the course of 45 minutes. Infusions will take place in the University of Mississippi     Medical Center's Post Anesthesia Care Unit and/or Short Stay Procedure Area. Patients will be     monitored for 30 minutes after the completion of their infusion. The inpatient psychiatry     team will assess all patients' suicidal ideations daily while they are inpatient at UMMC and     the primary outcome will be the patient's inpatient hospital course length.   "
22040|NCT02997124|"     The purpose of this study is to determine whether a supplemental Transversus Abdominis Plane     block administered intraoperatively improves the postoperative parameters in patients     undergoing Alveolar bone grafting with iliac crest harvest. It also aims to find out if there     is a decrease in the incidence of chronic pain or numbness at the harvest site.   "
21995|NCT02997709|"     Prostate cancer is the most common malignancy in men and nearly 30,000 deaths occur from the     disease each year. Not only is there significant mortality, there is also considerable     morbidity from primary and salvage therapies. Understanding which patients require     intensified treatment, as well as those who might not require treatment, would improve     outcomes on multiple levels. The cohort to be investigated will be comprised of men with     intermediate to high risk prostate cancer who are candidates for radiotherapy (RT). The     overarching objective of the CoMBINe trial is to identify pretreatment and post-treatment     prognostic and predictive factors derived from quantitative imaging prostate features, tumor     tissue gene expression signatures, and circulating tumor cells (CTCs). The CoMBINe trial is a     sister trial to another study, termed BLaStM (IRB# 20140627), in men who are candidates for     radiotherapy. CoMBINe also allows for men with oligometastasis who are sometimes treated with     RT to the prostate and limited metastatic sites.   "
21996|NCT02997696|"     The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group,     multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics     of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the     knee following 4 weeks of oral administration of ONO-4474.   "
21997|NCT02997683|"     In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and     CTEPH patients will get a training device to use at home for 3 months. Patients in the     Intervention group will be introduced in the training program on the wbv-device in the study     center 3-4 times and baseline Parameters will be collected before start of the home based     training. Patients randomized into the placebo arm be introduced into the training program     according to the interventional arm but not perfoming the exercises on the wbv-device but on     the floor.   "
21998|NCT02997670|"     Cardiac resynchronisation therapy (CRT) improves outcomes and symptoms in selected patients     with heart failure. However, around one third of suitable patients do not demonstrate benefit     following device implantation when assessed by echocardiography (heart scanning). This group     has poorer outcomes.      Response rate can be enhanced by altering timing delays between the pacing leads, but some     patients still fail to improve.      Quadripolar left ventricular leads are now widely used in CRT. The lead's four poles increase     the number of conformations available to the programmer, allowing multiple vectors to be     programmed simultaneously or sequentially. This allows programming to avoid, for example, a     patch of scar and find an area that will respond better to pacing. This technique is known as     multi-site pacing. CRT is often implanted along with a defibrillator lead in the right     ventricle, known as CRT-D. The defibrillator lead offers further combinations for pacing.      Goal of Research To evaluate an algorithm for assessing different multi-site pacing     combinations in optimisation of CRT      Outline The investigators will recruit 24 consecutive patients undergoing CRT-D implantation     for conventional indications at our hospital. At baseline, patients will undergo     echocardiography, exercise testing and assessments of functional ability and quality of life.     The device will be implanted as standard. Optimisation will be performed with an algorithm     using different vector combinations and assessing the heart's efficiency through     echocardiography and invasive pressure monitoring. The pacemaker will be programmed with     standard settings. After twelve weeks, the baseline investigations and optimisation algorithm     will be repeated and the device programmed according to the maximum efficiency. After a     further 12 weeks, the same parameters will be measured to look for improved response to CRT.      Potential Benefit To increase the response rate to cardiac resynchronisation therapy and     improve reliability of the technique   "
21999|NCT02997657|"     Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for     poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions),     while also providing skills that may buffer against stress and negative affect. The overall     objective of this project is to conduct a randomized controlled trial to test the efficacy of     PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation     treatment. Participants in both treatment conditions will receive nicotine replacement     therapy and a validated text-messaging intervention for smoking cessation that monitors     progress in quitting smoking and extends smoking counseling outside of the individual     face-to-face context.   "
22000|NCT02997644|"     The purpose of this study is to evaluate the use of post-operative opioid use after two     different educational interventions. The investigators will compare changes in pain,     disability and sleep between groups 6 months after elective lower extremity surgery.   "
22001|NCT02997631|"     Intravenous (IV) insertion is one of the most common procedures for children seeking medical     treatment in the Emergency Department (ED). This procedure is often painful and distressing     for children and families. This can result in an uncooperative child, a need for multiple     cannulation attempts, needle phobia, and dissatisfaction with care for family and healthcare     workers. Non-pharmacological treatments are emerging as a newly favoured adjunct to     pharmacotherapy, such as distraction therapy.      Distraction therapy involves engaging children in cognitive tasks in order to divert     attention from painful stimuli and reduce pain and distress. Currently, distraction therapy     is not utilized as a standard of care in the ED. Given children's enthusiasm for     technological devices, we propose that the use of a technologically enhanced device may be a     more effective distractor and may have a greater impact on pain reduction outcomes of patient     importance. The primary objective of this study is to compare the reduction of pain and     distress with the use of distraction (via the MEDi robot) versus current standard care in     children aged 6 to 11 years who are undergoing IV placement.   "
22023|NCT02997345|"     Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible     for 40% of preterm births in the United States. The PPROM Registry aims to identify possible     causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care,     and to review short term and long term outcomes of affected pregnancies and births.   "
22038|NCT02997150|"     NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of     Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic     syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy     via an increased production of regulatory T cells.   "
22041|NCT02997111|"     This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the     effect of energy drinks on platelet function. Participants' will have blood drawn prior to     and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.   "
22042|NCT02997098|"     This observational registry of patients undergoing liver surgery collects patients both     retrospectively and prospectively. Patients undergoing liver resection for any non-transplant     indication will be evaluated for clinical outcomes (such as surgical complications, survival,     and disease progression) based on clinical and patient factors (like indication, age, and     other treatments for the disease).   "
25530|NCT02951507|"     Comparison of new design of extra coronal castable precision attachment (OT unilateral     attachment) and conventional partial denture in patient satisfaction and biting force.   "
22002|NCT02997618|"     Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective     repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for     endovascular repair. This risk is associated with poor cardiorespiratory fitness which can be     measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak oxygen     uptake(peakVO2)<15ml/kg/min and anaerobic threshold(AT)<10.2ml/kg/min identifying patients at     increased risk of early death after AAA repair.3 These variables can therefore be used as     surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA     surgery; optimising these markers should improve fitness and decrease this risk. The optimal     duration and type of exercise training for improving peak VO2 and AT in AAA patients is not     known. AAA patients are unique as they are motivated to reduce the risk of impending surgery     but are afforded the time to improve their fitness as repair may not be needed for months or     even years.      The investigators propose a pilot randomised controlled trial to explore the effectiveness of     a 20-week community (either home or gym-based) exercise programme to achieve sustained     improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL,     habitual activity levels and cardiovascular risk will also be assessed. The results will     inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly     patients with cardiovascular disease and AAA.   "
22003|NCT02997605|"     The purpose of this study is to compare the proportion of patients who could withdraw from     prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a     hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease     activity.   "
22004|NCT02997592|"     Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A     prospective, single arm, safety and efficacy, open labeled multi-center study   "
22005|NCT02997579|"     Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of     patellar crepitus after TKA are related to many factors such as femoral component design,     surgical errors, and postoperative patellar baja. However, it is unclear whether patella     resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary     objective of this study are to compare the prevalence of patellar crepitus and the mean value     of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The     secondary objective is to study the association between patellar crepitus and vibroacoustic     signal.   "
22006|NCT02997566|"     Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical     structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the     better will be the prognosis. In this context, heart rate variability (HRV) stands out, which     is a non-invasive tool representing autonomic modulation, with potential prognostic value.     The literature showed there are no changes in HRV at rest using linear methods of analysis,     but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and     provide additional information to the linear. Objective: to analyze autonomic modulation     using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in     comparison to typical children. In addition, to correlate HRV analysis between them, also     between behavior and severity of the disease. Methods: this study involves both typical     children and children with ASD. Autonomic modulation will be performed using nonlinear     indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and     recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain     (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial     expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior     Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to     identify differences between moments and protocols two-way analysis of variance will be used     along with the Bonferroni post-test or Dunn post-test according to the data distribution.     Statistical significance will be set at 5%.   "
22007|NCT02997553|"     This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine     green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided     sentinel lymph node biopsy in patients with cancers and subjected to surgery.      The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope     (Techniciun99) in the detection of sentinel lymph nodes will be assess using an Optonuclear     probe (EURORAD S.A.).   "
22008|NCT02997540|"     The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently     measure the position of female breast lesions regardless of patient rotation and probe angle     during ultrasound examination.   "
22009|NCT02997527|"     This study is being done to determine if people with and without GERD or trouble swallowing     have increased esophageal mucosa impedance (food getting into the esophageal tissue).   "
22010|NCT02997514|"     The purpose of this study is to implement Solution Focused Coaching in pediatric     rehabilitation (SFC-peds) within the multidisciplinary neuromuscular clinic at Holland     Bloorview Kids Rehabilitation Hospital and evaluate its effect on children's ability to set     and attain personally meaningful goals. A secondary goal is to determine the impact of     SFC-peds on self-determination in children with neuromuscular conditions. This study aims to     compare two methods of SCF-peds delivery, a single coaching session vs. intensive coaching (5     sessions) on goal attainment. This study will also help researchers and clinicians understand     the types of goals that are set by children with neuromuscular conditions. Lastly, this study     is going to explore with the participants their perception of the feasibility of using this     methodology within a clinical context.   "
22011|NCT02997501|"     The aim of this study is to evaluate concordance of T790M mutation plasma testing between the     Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess the     efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or     metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and     are T790M mutation positive detected by any one of the four plasma testing platforms:     Cobas/Super-ARMS/ digital PCR/NGS.   "
22012|NCT02997488|"     Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes     provide easier intubation, help intubation difficulty, are used good tool for education.     McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.      The purpose of this study is to compare of routine endotracheal intubation with McGrath     Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier     and faster intubation.   "
22014|NCT02997462|"     There are many treatments that can improve how long and how well people live with heart     failure when they are outside the hospital. However, the investigators know less about how to     effectively treat hospitalized heart failure patients so that they do not have to return to     the hospital after they go home. Part of the problem is that the investigators don't     understand all of the causes of worsening heart failure.      Previous studies by other researchers suggest that white blood cells called monocytes are     over-active in heart failure. Under normal conditions monocytes help fight infections in the     body, but over-active monocytes release chemicals that could cause abnormal function of the     heart and blood vessels. The investigators' research group believes that over-active     monocytes may be an important reason that heart failure worsens before hospitalization.      In this study the investigators will collect blood samples on the day a patient comes into     the hospital, the day they return home, and the day they come back to the clinic for a     follow-up appointment. The investigators will measure the inflammation in the bloodstream and     the activity of monocytes from the patients' blood to see if there are changes in these     measurements as heart failure improves. The investigators will also call each patient several     times after they return home to ask questions about how they are doing.   "
22015|NCT02997449|"     Rationale: Accurate staging of lung cancer is important because it directs treatment and     determines prognosis. The development of Stereotactic Ablative Radiotherapy (SABR), has     revolutionized radiation therapy for early stage lung cancer and results demonstrate similar     outcomes in comparison to surgical resection of the lung tumor. The staging work-up program     for patients with a potentially resectable Non-Small-Cell Lung Cancer (NSCLC) includes at     least a computed tomography (CT) scan of the chest and integrated Positron Emission     Tomography - Computed Tomography (PET/CT) scans, and when indicated, invasive mediastinal     staging. However, patients who are treated with SABR do not routinely undergo the same nodal     staging work-up as do surgical candidates. As both surgery and SABR appear to achieve     comparable rates of local and regional tumor control, it appears only logical to perform a     similar staging work-up in all patients with early stage lung cancer who will be treated with     either of the two curative local modalities. In the past, a lack of invasive nodal sampling     before SABR was considered acceptable as invasive surgical staging (mediastinoscopy) was     widely considered the preferred procedure. However, with minimally invasive and safe     endosonography procedures now available, improved pre-treatment staging has become possible     for patient groups who are eligible for SABR, including those with significant comorbidities.      Hypothesis: Complete endosonographic (combined endobronchial and esophageal) staging of hilar     and mediastinal lymph nodes in patients with (suspected) non-small cell lung cancer (NSCLC)     will result in change of loco-regional nodal status in 20% of patients, in comparison to     staging by PET-CT alone.      Study population: Patients with either established or suspected early-stage NSCLC who are     medically inoperable, or who refuse surgery but are potential candidates for SABR with     curative intent (provided no intrathoracic metastases are present). Patients will undergo a     single scope complete mediastinal and hilar staging procedure (combined EndoBronchial     UltraSound (EBUS) and Transesophageal Endoscopic Ultrasound with EBUS scope (EUS-B)).   "
22016|NCT02997436|"     prospective interventional study. The aim is to analyse the effect of usual ongoing     treatments over the microvascular cutaneous response to galvanic current application (Current     induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations     due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at     low dose) abolishes the response .   "
22018|NCT02997410|"     This study investigates the efficacy of bio-oxidative ozone application in the treatment of     TMD of muscular origin.   "
22019|NCT02997397|"     In this study, the investigators aimed to find out the effect of a novel tourniquet     technique, in cases of excessive bleeding during cesarean delivery.   "
22020|NCT02997384|"     This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to     informing women about their risk of breast cancer and the screening methods recommended for     them according to the recommendations in force during a routine consultation at a general     practitioner, a gynecologist or a radiologist.   "
22021|NCT02997371|"     Traumatic brain injury (TBI) is a common condition with high degree of morbidity and     mortality (Hyder et al., 2007). Current treatment paradigms for TBI focus on mitigating     secondary injury and maintaining cerebral physiology (Carney et al., 2016), however, there     are currently no approved drugs that target the underlying conditions for patients suffering     from TBI (Bullock et al., 1999). It is increasingly recognised that the innate inflammatory     response to TBI may inflict injury (Lucas et al., 2006), and one of the most prominent     mediators of inflammation in the injured brain is the Interleukin-1 (IL-1) receptor pathway     (Allan et al., 2005). An endogenous antagonist to IL-1, is available in recombinant form     (IL-1ra, Kineret), and is known to be safe in TBI (Helmy et al., 2014).      In order to fully understand, and potentially optimize, the effect of Kineret, the     investigators wish to conduct a dose-response study by giving three cohorts (n=20 per group)     either placebo (isotonic saline), 1.5g or 3.0g of active substance administered intravenously     in a double-blind, randomized setting. The concentrations have in previous studies not been     shown to present any side-effects (Singh et al., 2014). The drug will be provided within 12     hours after trauma. The goal will be to provide a dose-response effect on the cerebral     inflammatory response. As secondary goals, the investigators will assess the brain damage by     measuring proteins in blood and cerebrospinal fluid, functional outcome and inflammation in     the brain using positron emission tomography.   "
22022|NCT02997358|"     The objective of LMS04 study is to better define the treatment strategy for patients with     metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first     line therapeutic option for these patients. LMS04 will test a new strategy for first line     therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the     interest of the association of trabectedin to doxorubicin in first line treatment followed by     trabectedin alone for non-progressive patients after 6 cycles of the association of     trabectedin and doxorubicin (the LMS02 design).      LMS04 will be the first phase III randomized study specifically dedicated to soft tissue     leiomyosarcoma in first line metastatic disease.      It is planned to compare a new doxorubicin combination (including trabectedin) with very     encouraging results followed by trabectedin maintenance therapy for non-progressive patients     to doxorubicin alone. Prospective ancillary translational studies will attempt to define     profiles of patients who could benefit from this new chemotherapy in an exploratory way.      The validation of a new first line option specific for LMS, identifying clinical factors that     characterize aggressiveness and responsiveness to treatment aims to have an important in the     spirit of personalized medicine in this rare and deadly disease.   "
22149|NCT02995707|"     This is an exploratory experiment, aims to explore the effective and safety of thalidomide in     the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce     blood transfusion, so as to avoid the adverse reactions caused by transfusion.15~30 patients     will be enrolled, including type α 5~13 cases, type β 10~17 cases.   "
22024|NCT02997332|"     The prognosis of patients with locally advanced SCCHN is poor. Results of recent randomized     trials evaluating induction chemotherapy by docetaxel, cisplatin, 5 fluorouracil are     conflicting, and benefit on overall survival is uncertain. Improve efficacy of induction     chemotherapy is important without increase toxicities. Durvalumab is a promising agent in     SSCHN. The safety of combination of docetaxel, cisplatin, 5 fluorouracil with durvalumab is     unknown.      The aim of the study is to evaluate the feasibility and the safety of the association of DCF     (standard regimen for induction in SSCCHN) and durvalumab. The safety profile of DCF and     durvalumab are different, so the expected toxicities should not be additive. The addition of     durvalumab to DCF could improve the efficacy of induction chemotherapy and the prognostic of     patients with SSCCHN.      Concerning the translational research, the aim will be to explore the relationships between     immune capacity, specificity, activation state and clinical outcome to help elucidate the     determinants of response to immunotherapy.   "
22025|NCT02997319|"     The purpose of this study is to determine whether night time eating that coincides with     elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the     MTNR1B risk allele.   "
22026|NCT02997306|"     This is a randomized, controlled, prospective study which relies on computer-assisted skin     image processing of scar photographs, to establish whether simple interrupted or running     sutures are associated with the greatest degree of erythema when used to repair surgical     defects arising from Moh's micrographic surgery (MMS) of facial skin cancers. Furthermore,     through the use of the customized software that the investigators have developed for this     purpose, an effort will be made to better understand the evolution (including progression and     subsequent regression) of erythema over time in these scars.   "
22027|NCT02997293|"     The Enhanced Recovery After Surgery system for perioperative care of patients undergoing     major abdominal surgery, particularly colorectal surgery, was formed in Europe by a surgeon     named Henrik Kehlet in 1994. Dr. Kehlet observed that his patients undergoing colorectal     surgery were hospitalized postoperatively for extended periods of time due to prolonged     return of the normal intestinal physiology and of other bodily functions. He formulated a     system of perioperative care that focused on preserving and promoting faster return of normal     physiologic function of the human body following surgery.      The Enhanced Recovery After Surgery system has been implemented in the United States for     nearly a decade now, primarily at major academic institutions. Numerous publications exist     that report the dramatic positive impacts of this program on reducing postoperative hospital     length of stay, reducing 30-day hospital readmissions, and improving patient satisfaction.      The University of Arkansas for Medical Sciences implemented several components of the     Enhanced Recovery After Surgery system for colorectal surgery in June 2015. This is an     observational study to look at the impact that program (Group 1) in shortening hospital     length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale     scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day     readmission when compared to patients who had colorectal surgery performed at University of     Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After     Surgery system (Group 2).   "
22028|NCT02997280|"     Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic     stem cell transplantation, while steroid-refractory chronic GVHD significantly increases     morbidity, aggravates quality of life and may also impact survival. Currently there is no     standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK)     inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate     and survival of patients with either acute or chronic srGVHD. This study prospectively     evaluates the efficacy of ruxolitinib in srGVHD patients.   "
22029|NCT02997267|"     The aim of the study was to compare the restoration of the GI tract by the closure of     protective ileostomy after low anterior resection for rectal cancer after 14 days and more     than 3 months.   "
22030|NCT02997254|"     This is a cohort study to evaluate algorithms for mapping atrial fibrillation and for     detecting rotational activity.   "
22031|NCT02997241|"     The purpose of the study is to determine the relationship between change of gene copies and     recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis     compared to Oncocare detection prognosis.   "
22032|NCT02997228|"     This randomized phase III trial studies how well combination chemotherapy, bevacizumab,     and/or atezolizumab work in treating patients with microsatellite instability-high colorectal     cancer that has spread to other places in the body. Drugs used in chemotherapy, such as     fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Monoclonal antibodies, such as bevacizumab and atezolizumab, may     interfere with the ability of tumor cells to grow and spread. Giving combination     chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with     colorectal cancer.   "
22033|NCT02997215|"     This study was to evaluate the effect of intraoperative intravenous lidocaine on     postoperative pain management after laparoscopic cholecystectomy. Half of patients will     receive intravenous lidocaine during procedure, the rest half of patients will receive     regular anesthesia care and placebo treatment.   "
22034|NCT02997202|"     The purpose of this study is to compare relapse-free survival between participants with     FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem     cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after     the time of engraftment for a two year period.   "
22035|NCT02997189|"     This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of     OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from     cisplatin chemotherapy regimens in the treatment of cancer.   "
22036|NCT02997176|"     This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in     patients with advanced solid tumors and impaired hepatic function.   "
22037|NCT02997163|"     This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients     with advanced solid tumors and impaired renal function.   "
22074|NCT02996682|"     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and     tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without     ribavirin (RBV) for 12 weeks in adults with chronic HCV infection and decompensated     cirrhosis.   "
22043|NCT02997085|"     Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective     means of decreasing pain levels following treatment, and for significant periods of time.     Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity     associated with pain. While VR is clearly a promising, drug-free option for pain treatment,     existing VR systems are expensive and use unconvincing graphics. Recent advances in VR     technology (i.e., improved realism and immersion using 360-degree 3D technology and more     affordable delivery systems) allow the development of more realistic and more cost-effective     applications. Capitalizing on these advances and the investigators' experiences with VR     intervention development and evaluation, the current study will test a state-of-the-art VR     experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and     compare it to established standard computer generated imagery (CGI) 360° VVR content for pain     management intervention in a medical setting. The participant's participation will help the     investigators determine which VR intervention is most effective in reducing acute pain in     hospital patients.   "
22044|NCT02997072|"     The purpose of this study is attempt to establish optimum drive pressure of high frequency     jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by     electrical impedance tomography.   "
22045|NCT02997059|"     This was prospective study randomized in two controlled parallel groups verum versus placebo.     The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on     the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our     previous research having established i) a link between intestinal inflammation and the     opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii)     the demonstration that this yeast species could be at the origin of ASCA, a prominent     serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of     ASCA and/or reduce the occurrence of recurrences.   "
22046|NCT02997046|"     Conventional vascular imaging techniques are often either contra-indicated in chronic kidney     disease (CKD) patients due to their relative invasiveness, risks and cost. Computed     tomography angiography (CTA) requires radiation and nephrotoxic iodinated contrast which may     precipitate significant worsening of renal function and even prompt the need for institution     of dialysis. Magnetic resonance angiography (MRA) using gadolinium-based contrast agents has     been associated with the rare disease nephrogenic systemic fibrosis. Alternative imaging     methods also have drawbacks: for example, this frail patient group has a higher risk of     complications from conventional invasive catheter-based angiography, non-contrast-enhanced     MRA allows visualization of smaller arteries but is less accurate for larger vascular     structures, and ultrasound is often not appropriate for evaluation of the deep vessels of the     abdomen and pelvis.      Ferumoxytol is an ultrasmall superparamagnetic iron oxide particle encapsulated by a     semisynthetic carbohydrate, which was initially developed as a magnetic resonance imaging     (MRI) contrast agent in 2000. However, interest in ferumoxytol as a therapeutic agent for the     treatment of iron deficiency anaemia in the setting of CKD eclipsed its use as MRI contrast     agent. During the last decade, ferumoxytol has gained appeal as an MRI contrast agent in     patients with estimated glomerular filtration rates <30mL/min and there are reports in the     literature for its safe use and utility in both adult and pediatric patients with CKD.      Participants will be selected from those who have been referred for assessment prior to     kidney transplant or prior to vascular access creation for haemodialysis and will be divided     into three groups. The first group will include patients who will undergo a CTA of abdominal     and aortoiliac vasculature as part of their preparation for potential kidney transplantation.     The second and third groups will include patients who are having a fistula or a graft created     for dialysis, respectively. These patients are routinely having US vascular mapping to     visualise the blood vessels before a fistula or a graft is created. Additionally, patients     included in the second and third groups are routinely having surveillance scans of their     fistula or graft at 6 weeks following creation. Study participants undergoing standard     imaging tests as part of their clinical care will also have ferumoxytol-enhanced MRA (FeMRA).   "
22047|NCT02997033|"     Population-based, longitudinal cohort study designed to evaluate changes in bone mineral     density, bone geometry, body composition, parameters reflecting muscle force, and sex steroid     status in healthy young men, as well as their interactions, over a period of +-10 years.   "
22048|NCT02997020|"     The purpose of this study is to establish the novel endoscopically-directed sinus potential     difference (EDSPD) assay as an endpoint for therapy of sinus disease.   "
22049|NCT02997007|"     Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both     associated with changes in brain network integrity. Episodic memory is especially affected in     Alzheimer's disease, but is also decreased in healthy ageing. Consequently, the     memory-relevant brain networks are especially altered. Transcranial direct current     stimulation (tDCS) has previously been implemented in different clinical- and non-clinical     settings and has shown to beneficially influence network connectivity. The neural correlates     of single-session tDCS have been investigated, however, the neural effects of repeated tDCS     remain unknown. Furthermore, knowledge about the (long-term) neural mechanisms of repeated     tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a     treatment option in future studies.   "
28430|NCT02913534|"     The aim is to identify in patients with brain metastases the predictive factors of overall     survival, survival without local recurrence and survival with progression-free brain     metastases after complementary whole brain radiotherapy.   "
22050|NCT02996994|"     This is a retrospective chart review using TriHealth Electronic Privacy Identification Center     (EPIC) and previously developed databases for TriHealth Institutional Review Board (IRB)     approved research studies within the Division of Urogynecology and Reconstructive Pelvic     Surgery to determine the predictors of postoperative pain specific to the urogynecologic     patient population.   "
22051|NCT02996981|"     This is a retrospective chart review using Electronic Privacy Identification Center (EPIC)     database to determine if the addition of cranberry juice capsules to our discharge medication     regimen for patients discharged home with an indwelling urinary catheter following pelvic     floor gynecology surgery reduced the incidence of UTI.   "
22052|NCT02996968|"     This study is to determine if self-discontinuation of transurethral foley catheters in     patients diagnosed with postoperative urinary retention (POUR), which is defined as the     continued need for catheterization, following impatient pelvic organ prolapse surgery is     non-inferior to office-discontinuation.   "
22077|NCT02996643|"     Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine     associated with vertebral rotation. Brace treatment is the most commonly used non-surgical     treatment. To obtain the best possible outcome, the best in-brace correction within the     patient's accepted tolerance must be provided. However, in the existing clinical practice,     the immediate in-brace correction cannot be measured during the design and fitting of the     brace because the correction is determined using a radiograph. This study is to evaluate the     effect of applying ultrasound to measure the stimulated in-brace correction during brace     casting.   "
22053|NCT02996955|"     Rationale: Low back pain is worldwide a common musculoskeletal condition with a high number     of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a     next episode could be prolonged by advising an active lifestyle. Advising regular physical     activity is the mainstay in physical therapy treatment. This includes an appeal to patients     to adhere to an activity advice. Patient adherence to an activity advice is poor. Many     factors influence adherence. In this study an intervention consisting of treatment of illness     perceptions with or without organizing social support to increase adherence to an activity     advice will be investigated.      Objective: The primary objective of this study is to investigate whether social support by a     partner or friend and treatment of patients' illness perceptions influences the rate of     adherence to an activity advice compared to treatment of patients' illness perceptions alone     in patients suffering non-specific low back pain. Secondary objectives are; a) whether     'treatment of illness perceptions' changes patients' maladaptive illness perceptions into     realistic ones, b) whether maladaptive illness perceptions, comorbidity and/or     overweighed/obesity and/or rate of recurrences of non-specific low back pain and/or attitude     and intention to physical activity influences patient's adherence to an activity advice.      Study design: This study is a multi-centre randomized two-arm controlled clinical trial.      Study population: Patients ≥18 years presenting with at least a second episode of     non-specific low back pain.      Intervention: Patients in the intervention and control group will be asked to perform a     physical activity advice. During two physiotherapy treatment sessions treatment of illness     perceptions is performed in both groups. In the intervention group organizing social support     by a partner or friend is added.      Main study parameters/endpoints: Twenty-five percent absolute improvement of walking and/or     cycling according the NNGB in the intervention group is clinically relevant.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: During four appointments several questionnaires have to be filled in and during     two physiotherapy treatment sessions half an hour treatment of illness perceptions will be     performed. Social support by a partner or friend will be organized during the same     physiotherapy treatment sessions in the intervention group. During three separate weeks     patients have to wear an activity monitor. Patients will be treated according to the Dutch     Low Back Pain guideline; no adverse effects will be expected.   "
22054|NCT02996942|"     The KAPPa project has the aim to create an international database in which information about     clinical features, therapeutic management, burden of illness and costs of severe and moderate     haemophilia A patients from different countries and sites is collected. The aim of this     project is to analyse the influence of such different characteristics on medical,     psychosocial and economic outcomes in patients over the long-term.   "
22055|NCT02996929|"     The study's main purpose is to evaluate the safety and performance of the LeadExx LC System     and its ability to safely extract leads.      The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead     extraction will be based upon the applicable Heart Rhythm Society guidelines or European     Heart Rhythm Association (EHRA).   "
22056|NCT02996916|"     Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a     major target of the damaging effects of hypertension. Hypertension has been recognized as the     leading cause of dementia as well as the most important risk factor for stroke and vascular     cognitive impairment. Although glucose is the principal cerebral energy source, impact of     hypertensive treatment on cerebral glucose metabolism is poorly understood.   "
22057|NCT02996903|"     The Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy     IN Daily Practice in 2017 (PROTECTION-VI) study is a prospective registry and     investigator-initiated initiative without third-party funding, which will collect and analyze     the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA) studies in     current daily practice worldwide. Particularly, the study will assess the use of strategies     for dose reduction during CCTA.      A decade ago, the multicentre observational PROTECTION-I study has revealed that the     dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x cm.     This corresponds to an estimated effective dose of approximately 12 mSv. Since then a variety     of techniques have been developed and enhanced in order to reduce radiation exposure during     CCTA. Recent studies demonstrated feasibility of dramatically reduced effective radiation     doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of patients at     scientific expert centers. However, it remains unclear, if such low-level radiation dose     exposure may be achieved in clinical routine and if diagnostic image quality is maintained.     In order to analyze the magnitude of radiation dose exposure of CCTA in today's clinical     practice and the current use of dose-saving techniques, we designed the PROTECTION-VI study.     Eventually, this study may contribute to further improving radiation dose exposure for     patients undergoing CCTA.   "
22058|NCT02996890|"     Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in     48 healthy volunteer subjects.      After completion of screening procedures, the subjects are randomized to one of four     treatment groups (different dosage strengths and placebo) All subjects will receive study     treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with     two vaccinations will receive a second treatment at day 28.      Subjects will return on day 56 for the final visit.   "
22059|NCT02996877|"     The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort     design to follow patients who have multivessel or left main coronary artery disease     (surgical anatomy according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed     ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be     selected to participate in the registry from a national network of leading centers across the     United States with recognized expertise in both complex PCI and coronary artery bypass     surgery. We will invite leading cardiac centers, as defined by US News and World reports     rankings for heart care. Additional sites may be added to meet the target enrollment goal.   "
22075|NCT02996669|"     This is a multicenter longitudinal study that aims to identify, develop and validate a set of     measures that can be used as stratification biomarkers and/or sensitive and reliable     objective measures of social impairment in autism spectrum disorders (ASD) that could serve     as markers of long term clinical outcome. The main study will include 275 individuals: 200     ASD subjects between 6-11 years old, and 75 TD subjects roughly matched by age and sex to the     ASD group.   "
22060|NCT02996864|"     College students are in a newly independent phase of life; many of whom encounter unhealthy     dietary decision- making, barriers to physical activity, and poor sleep behaviors. Healthy     Detours is a location-based smartphone application tailored in real-time to a student's     schedule and locale, and aims to guide students toward healthier eating, exercise, and     lifestyle choices as a way to prevent the onset of damaging and costly health outcomes.     Through a randomized control trial, this Phase II project will test the effectiveness of an     evidence-based smartphone application that will provide students with on-demand,     location-specific information about healthy lifestyle choices.   "
22078|NCT02996630|"     Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in     100 newborns per year. Children with CHD are a known risk population for brain injury, with     neurodevelopmental alterations shown over time in up to 50% of cases. No adequate description     exists of the type of neurocognitive anomalies or risk factors associated with CHD, and     consequently no prognostic markers that may allow identification of high-risk cases are     available.   "
22061|NCT02996851|"     Oral antithrombotic medications (OAM) are used for the prevention and treatment of thrombotic     disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH) may have     particularly devastating consequences with high morbidity, disability and mortality rates.     The efficacy and safety profiles of OAMs are generally assessed in randomized controlled     trials (RCT), but included patients are often highly selected and may not be representative     of users in everyday clinical practice in terms of follow-up routines, age, gender, drug     compliance, and polypharmacy. Moreover, it is often unclear whether or not traumatic ICHs are     registered and reported in RCTs. Drifts in indications and treatment criteria may also be     seen in everyday practice and drug discontinuation due to precautionary concerns including     compliance, fall risk and comorbidity may be forgotten. Collectively, these factors may lead     to other and potentially higher traumatic ICH rates in general clinical use than reported in     RCTs.      The incidence rates of traumatic ICH in patients on OAMs in the general population remain     unknown. In this nationwide registry based pharmacoepidemiological study we will investigate     the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008 through     2014.   "
22062|NCT02996838|"     To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a     reasonable regimen for subsequent research.   "
22063|NCT02996825|"     This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and     gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive     ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer     that has come back. Monoclonal antibodies, such as mirvetuximab soravtansine, may interfere     with the ability of tumor cells to grow and spread. Drugs used in the chemotherapy, such as     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving mirvetuximab soravtansine and gemcitabine may work better in treating patients with     FRalpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative     breast cancer.   "
22064|NCT02996812|"     This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of     single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with     post-bariatric hypoglycemia.   "
22065|NCT02996799|"     For preterm infants, deferred cord clamping has been shown to improve both short term and     long-term neonatal outcomes without an established harm for both the mother and her     infant.The interference with resuscitative measures for the neonate or the mother is a risk     that continued to hamper the implementation of delayed cord clamping in many centers around     the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method     of placental transfusion that involves milking of the umbilical cord.   "
22066|NCT02996786|"     The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood     biochemical parameters in male recreational runners.   "
22067|NCT02996773|"     The purpose of this study is to evaluate the safety and efficacy of substituting day +4     cyclophosphamide with post-transplant bendamustine in myeloablative (MAC) or reduced     intensity conditioning (RIC) haploidentical hematopoietic cell transplantation (HHCT) for     advanced leukemia and lymphoma patients.      The phase I component of the study is to evaluate the safety of completely substituting the     second dose of post-transplant cyclophosphamide (PT-CY) given on day +4 with bendamustine     (PT-BEN).      The phase II component of the study will continue to evaluate the safety and efficacy of     subjects who receive PT-CY on day +3 and PT-BEN on day +4.      Approximately, a total of 32 subjects will be treated under this protocol. Approximately 12     to 15 subjects will be used as control, subjects that receive no PT-BEN, for direct     comparison.   "
22068|NCT02996760|"     Women in assisted reproduction treatment they receive own or donated embryos and presenting     an endometrial development less than 5 mm despite having received treatment with estrogen     therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level     applications to improve endometrial thickness endometrial preparations for embryo transfer.   "
22069|NCT02996747|"     The purpose of this project is to verify possible clinical and radiological findings with     regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In     addition, this study presents the outcome of patients with enchondroma and low grade     chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).   "
22070|NCT02996734|"     The purpose of this project is to present the outcomes of patients with giant cell tumor of     bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.   "
22071|NCT02996721|"     This study evaluates whether achieving 25-hydroxyvitamin D (25[OH] Vit D) levels (>40 ng/mL)     among myocardial infarction patients will result in a reduction of cardiovascular-related     adverse events. Half of the patients will be randomized to receive standard of care and half     will receive clinical management of 25[OH] Vit D levels.   "
22072|NCT02996708|"     The purpose of this study is to determine whether Teleconsultation would a)be effective and     cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having     a correct follow-up, and less transportation, and b) get a high satisfaction from the parents     and from the professionals   "
22073|NCT02996695|"     Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac     safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in     malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of     PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides     sterile protection against naturally-occurring malaria in malaria-experienced adults. The     study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive,     residing in Bougoula Hameau and surrounding villages, Mali.   "
22076|NCT02996656|"     INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction     for all orthopaedic procedure with implantation of internal fixation device. With the     increasing rate of identified P. acnes shoulder surgery infection despite the use of     recommended skin preparation and preoperative prophylactic antibiotics, a question arises; Is     Cefazolin the most effective prophylactic antibiotic for shoulder surgery? The objective of     this study is to determine if Ceftriaxone is superior to Cefazolin as a prophylactic     antibiotic for skin colonization with P. acnes in primary shoulder surgery   "
22081|NCT02996591|"     The purpose of this study is to determine if there is a difference in patient outcomes with     general anesthesia versus spinal anesthesia when given in addition to popliteal and adductor     canal nerve blocks for foot and ankle surgery. Popliteal and adductor canal nerve blocks are     injections of local anesthetic agents near nerves in the back and front of the knee going to     the foot and ankle that provide numbness during and after surgery. These peripheral nerve     blocks offer good pain control and reduce the need for opioids (opioids are pain medications     such as morphine, Dilaudid, and oxycodone). General anesthesia involves the flow of oxygen     and anesthesia gas through a tube which, along with additional intravenous medications,     causes unconsciousness and unawareness of sensations during surgery. Spinal anesthesia     involves an injection of local anesthetic in the lower back, which causes numbness below the     waist. In addition to spinal anesthesia, a sedative is typically given intravenously to cause     relaxation and sleepiness throughout surgery.      General, spinal, and nerve block anesthesia are all routinely used for surgery at the     Hospital for Special Surgery. General or spinal anesthesia is typically used in addition to     peripheral nerve blocks during foot and ankle surgery to 1) allow the surgeons to use a thigh     tourniquet to reduce bleeding, 2) provide anesthesia earlier, and 3) prevent unwanted     movement. However, it is unclear whether general or spinal anesthesia provides better patient     outcomes when given with peripheral nerve blocks. Some reports show that on its own, spinal     anesthesia has advantages over general anesthesia in terms of side effects such as nausea and     pain. However, these advantages may also be gained from combining peripheral nerve blocks     with general anesthesia. Spinal anesthesia can be associated with headache and backache,     although headache and backache can also happen after operations performed with general     anesthesia. A previous study at the Hospital for Special Surgery showed low rates of nausea     among patients who received nerve blocks with spinal anesthesia, and no nausea among patients     who received a nerve block with general anesthesia. Therefore, the primary aim of this study     is to determine if, as a treatment, either general or spinal anesthesia has advantages over     the other treatment in terms of readiness for discharge, side effects, pain and patient     satisfaction in an ambulatory foot and ankle population.   "
22082|NCT02996578|"     This project aims to investigate whether consumption of cocoa polyphenols has an impact on     cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a     result of an improvement in risk factors associated with cognitive decline in ageing.   "
22083|NCT02996565|"     This pragmatic trial will compare two team-based care models for managing hypertension, Best     Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care     system in Minnesota. Clinics in the study are randomized to offer one of the two treatment     models to participants with uncontrolled hypertension.      The investigators aim to determine a) whether one model is more effective than the other for     lowering patient's blood pressure and b) which model patients prefer.   "
22084|NCT02996552|"     The therapeutic strategy making in patients with ≤2 + functional tricuspid regurgitation (TR)     is extremely controversial: some observational studies have suggested that perform the     tricuspid annuloplasty in all patients undergoing mitral valve surgery have a dilated     tricuspid ring, regardless of the degree of failure, may provide a clinical benefit, while in     other observational studies such benefit has not been documented.      The ESC Guidelines assign the class IIa recommendation in patients with tricuspid     regurgitation≥ 2+ and dilated annulus, if surgery is concomitant to the repair or replacement     of the mitral valve; this means that although the debate still ongoing, experimental evidence     or expert opinion is in favor of the effectiveness and usefulness of the intervention in the     patient with these clinical features.      The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in     the early stage. The investigators enrolled patient with TR≤2+ and annular dilation     undergoing mitral valve repair.      Primary end-point will be the freedom from recurrence of TR≥3+ and from progression by 2     degrees compared to pre-operative, at discharge and 12 months after surgery, assessment by     transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of     combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at 5     and 10 years after surgery.      This will be an experimental superiority, prospective, spontaneous, single-center, randomized     trial.      Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1, to     receive mitral repair only (Mitral-Only group) ore both mitral and tricuspid repair (M & T     Repair group).   "
22104|NCT02996292|"     This experimental study will evaluate the effect of active and passive self-ligating brackets     in treatment of crowding, compared with the control group of conventional brackets in class I     malocclusion without extraction.      The study sample will consist of 66 patients with 3-6mm crowding. The sample will be     allocated randomly into two experimental groups, in addition to a control group.      The brackets will be applied using indirect bonding method for all patients. The     dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using     CBCT radiographs; pre and post- treatment changes for each group will be evaluated     individually.   "
22085|NCT02996539|"     Several studies have investigated an association between cardiac autonomic neuropathy (CAN)     and albuminuria, glomerular filtration rate, or both, and hypothesized that CAN is involved     in the pathogenesis of nephropathy. However, most of these studies had focused on Caucasians     and were limited to a small number of patients with type 1 diabetes mellitus, or had used a     conventional Ewing battery of tests based on dynamic cardiovascular maneuvers.Yet, there is     consistent data showing that Asian diabetic populations, including the Chinese, have a higher     risk of renal complications than Caucasians do.      The present study investigated an association between heart rate variability (HRV) parameters     and diabetic kidney disease (DKD) in Chinese type 2 diabetes mellitus (T2DM) patients,     specifically through time and frequency domain analyses of HRV and urine albumin creatinine     ratio (UACR) or estimated glomerular filtration rate (eGFR).   "
22086|NCT02996526|"     Population-based single centre, blinded, prospective cohort study of the impact of recurrent     laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest     is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and     mortality outcomes will also be determined.   "
22087|NCT02996513|"     For assessing body retinol pools in preschool children, it is recommended that a blood sample     is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A     should be controlled. Shortening of this period as has been validated for adults would reduce     the burden for the children as well as improve research efficiency. The aim is to validate a     4-day protocol for assessing body retinol pools in preschool children by modelling data     derived by retinol isotope dilution (RID) method. Venous blood samples will be collected of     60 children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood     sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing     in subgroups of 6 children, randomly divided over the 10 additional time points. Body retinol     pools will be modelled, and the time point at which a parsimonious model applies (presumably     at day 4) will be assessed.   "
22150|NCT02995694|"     The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol     vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol     describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7     day treatment.   "
22088|NCT02996500|"     This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and     active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at     Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to     MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting     conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered     orally BID for 12 weeks in a blinded fashion.   "
22089|NCT02996487|"     The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in     patients who are colonized with C. diff who are admitted to the hospital and need antibiotics     for another infection.   "
22090|NCT02996474|"     Background:      Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not     treated. Treatment for AML that has not responded to treatment (refractory) or has returned     after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy     drug, combined with a less intense chemotherapy, may be able to help.      Objective:      To test if pembrolizumab, in combination with decitabine, is a possible treatment for people     with relapsed or refractory AML.      Eligibility:      Adults 18 years of age and older with refractory AML or relapsed AML.      Design:      Participants will be first screened for eligibility.      The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles.     Participants may be in the study for up to 2 years if they are responding to the treatment.      The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an     outpatient.      Participants will get pembrolizumab at the beginning of each cycle through an IV.      Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other     cycle.      Participants will give blood samples.      Participants will have bone marrow exams. A needle will be inserted into the hip to extract     cells from the bone marrow.      Some participants may give a sample of saliva from the inside of their cheek.      Some participants may give a small skin sample. The top layer of the skin is removed.      Some patients may require leukapheresis before starting treatment. This is a procedure to     remove leukemia cells in the blood stream.   "
22091|NCT02996461|"     Background:      People get Zika virus from infected mosquitos. They usually don t get very sick. But birth     defects were reported in babies born to mothers who had Zika infection. In rare cases, people     with Zika infection had a nervous system disease that causes severe muscle weakness and can     be life threatening. A new vaccine made from DNA in the code for a Zika virus protein could     help the body build an immune response against the virus.      Objectives:      To see if a new vaccine against Zika virus disease is safe and causes any side effects. To     study specific immune responses to the vaccine.      Eligibility:      Healthy people ages 18-50      Design:      Participants will be screened with:      Medical history      Physical exam      Urine tests      Participants will have 18 visits over 2 years.      Participants will be randomly assigned to 1 of 3 groups. All will get 3 vaccines at 3     separate monthly visits. They will receive the vaccine in the upper arm muscle. Some will get     it by needle and syringe, others by a device that uses high pressure to push the vaccine     through the skin.      Vaccine visits last 4-6 hours. Participants will get a thermometer to measure their     temperature and a ruler to measure any skin changes at the injection site. They will record     this data for 7 days after each injection.      Other visits last 1-2 hours. These include:      Evaluation of any health changes or problems      Blood tests: Some samples may be used for future research.      Participants with side effects may have extra visits.   "
22100|NCT02996344|"     This randomized control study responds to the need for effective suicide prevention     education/training that is grounded in adult learning theory and advances in education, in     the context of a changing health care landscape where primary care providers are likely to     encounter suicidal individuals. The study will test the effectiveness of suicide prevention     education for providers-in-training by comparing two conditions: 1) A Control learning group:     includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online     via brief videos, and 2) An Experimental learning group: includes didactics plus two     standardized patient (SP) interactions. One Experimental learning group SP interaction will     be in person and the other will be conducted remotely using a secure webcam service (OoVoo).     All SP interactions will be recorded. Both groups will be compared in terms of their suicide     prevention skills using an SP 'test case' at 6-month follow up. The primary research question     is to learn about the impact of practice (though SP simulation) over and above didactics     alone.   "
22092|NCT02996448|"     Background:      AD-HIES is a disease that weakens the immune system. It puts people at risk for infections,     particularly Staph and Candida infections. Researchers want to test a vaccine that may help     keep people from getting these infections, which would help people with AD-HIES.      Objective:      To test the new vaccine NDV-3A for protection against infection from the yeast Candida and     the bacterium Staphylococcus aureus (Staph).      Eligibility:      Adults ages 18-55 who have AD-HIES      Healthy volunteers ages 18-55      Design:      Participants will have 6-7 study visits over 6-7 months. They will also be contacted by phone     in between some visits.      Participants will be screened with a medical history, physical exam, and blood and urine     tests.      Participants will have 2 baseline visits. They will have repeat the screening tests. They     will have samples of saliva, stool, skin, mucus (oral, nasal, and/or vaginal) collected.     Vaginal and stool samples are optional. Any eczema on their skin will be looked at.      Participants will fill out symptom diary cards to record how they feel.      Participants will have the NDV-3A vaccine injected into a muscle in the arm.      Participants will return the next 2 days. They will have a physical exam. Blood will be     collected.      Participants will have 2 more follow-up visits at the NIH. They will have a physical exam.     They will have blood, saliva, stool, skin, vaginal fluid, and/or mucus samples collected.     Vaginal and stool samples are optional.      Participants will be called once a month for 5 months after the vaccination. There is an     optional visit about 6 weeks after the vaccination. Participants will provide a blood sample     at this visit....   "
22093|NCT02996435|"     The primary purpose of this study is to evaluate the effectiveness of an intervention with a     mobile adherence platform, compared to physician- or nurse-guided standard of care, to     improve medication adherence to rivaroxaban in participants who have recently initiated     treatment with rivaroxaban for stroke prevention in atrial fibrillation based on an     assessment of the proportion of days covered (PDC) of rivaroxaban treatment.   "
22094|NCT02996422|"     Most of the nation's serious chronic health challenges and causes of death, including     diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both     poor diets and associated disease are disproportionately common in the Appalachian counties     of eastern Kentucky, a region with stark health inequities, including elevated rates of     obesity, overweight, and premature mortality. The purpose of this study is to evaluate a     multi-component intervention developed through community-based participatory research methods     for improving access to healthy foods and enhancing dietary intake in eastern Kentucky. The     intervention components evaluated in this study consist of: 1) a school-based campaign to     promote water consumption in middle and high schools and 2) a series of group cooking classes     for adults.   "
22095|NCT02996409|"     Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual     treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In     most cases this gives satisfactory results, however there is a significant group of patients     in which the exercise program is not sufficient. Prior to our study, three United Kingdom     based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's)     in chronic midportion Achilles tendinopathy. They all showed promising results. However none     of these studies had an adequate control group. This double-blind, placebo-controlled,     randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection     in chronic midportion Achilles tendinopathy.   "
22096|NCT02996396|"     Multicenter, single arm, open label, registry study with consecutive, eligible patient     enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System     (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as     per institutional standard of care thereafter through to 5 years (total follow-up commitment)   "
22097|NCT02996383|"     In England each year over 70,000 people fracture their hip. Most of these patients are     elderly females with the fracture occurring after a simple trip or stumble. Approximately     half of these fractures are classified from their relationship to the hip joint capsule as     intracapsular. These fractures are subdivided into those that are displaced and those that     are undisplaced. The majority of displaced fractures are treated with a replacement     arthroplasty. Current treatment for the undisplaced fractures is generally by internal     fixation of the fracture using screws and a plate, although some centres prefer replacement     arthroplasty.      A recent randomised study on patients from Norway with undisplaced intracapsular fractures     treated with either internal fixation or arthroplasty has just reported reduced complications     and re-operations for those patients treated with an arthroplasty. In addition functional     results were marginally better for those patients treated with an arthroplasty. Current     practice in the UK is generally to treat these fractures by internal fixation. This study     aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the     Norwegian study.      Patients who satisfy the inclusion criteria and are willing to participate will be randomised     to receive either reduction and internal fixation of the fracture with a screw and plate     device or alternatively replacement of their femoral head with an artificial hip replacement     (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be     discharge home when able, with follow-up review in the hip fracture clinic. Subsequent     follow-up for the research project is by phone calls from a research nurse who is blinded to     the type of treatment that the patient has received. There will be no additional     investigations or out-patient follow-up visits for these patients in comparison to normal     treatment protocols. Results of the study will ultimately be published in a medical journal.   "
22098|NCT02996370|"     Regenerating a predictable inter-implant papilla is the most complex and challenging aspect     of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision     technique and conventional midcrestal incision technique for interimplant papilla     reconstruction in a 6 month clinical trial.   "
22099|NCT02996357|"     This study aims to identify patient characteristics associated with the development of     Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).      380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19     possible risk factors will be collected at one point in time by the research team. Different     sources and methods will be used to collect patient data: skin assessment, patient record,     direct patient observation, routine blood samples.   "
22101|NCT02996331|"     The purpose of this study is to determine whether repositioning frequency can be extended for     nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer (PrU)     development. The investigators will also determine how changes in medical severity interact     with changes in risk level and repositioning schedule to predict PrU development. This study     will advance knowledge about repositioning frequency and clinically assessed PrU risk-level     in relation to medical severity. Outcomes of this research will contribute to future     guidelines for more precise preventive nursing practices and refinement of PrU prevention     guidelines.   "
22102|NCT02996318|"     The aim of the study is to investigate the non-inferiority of the new sirolimus-coated     balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance,     safety and efficacy in coronary DES in-stent restenosis.   "
22106|NCT02996266|"     This study will assess the impact of fever prevention on fever burden and short- and     long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo     fever prevention using a targeted temperature management system and half of the subjects will     be treated for fever should it develop.   "
22107|NCT02996253|"     The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon     ruptures has demonstrated good functional outcome, but an extensive surgical field at a     vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL     transfer may reduce the risk for soft tissue problems. Functional outcome parameters are     investigated, wound/soft tissue complications registered.   "
22108|NCT02996240|"     Assess the impact of dietary omega 3 free fatty acids breast cancer patients.   "
22109|NCT02996227|"     Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous     Epidural Analgesia With Bupivacaine   "
22110|NCT02996214|"     The purpose of this study is to investigate the efficacy and the safety of paclitaxel     liposome injection and carboplatin compared with gemcitabine and carboplatin as first-line     therapy in advanced squamous cell carcinoma of lung.   "
22111|NCT02996201|"     The aim of this study is to determine whether the use of breast cancer patients' own     electronic reporting of side effects to chemotherapy in a treatment setting has an impact on     the handling of side effects and on the number of hospitalizations, febrile neutropenia and     dose adjustments. We are using the Patient-Reported Outcomes version of the Common     Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side     effects.   "
22112|NCT02996188|"     The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense     ascites using non-invasive inert gas rebreathing.   "
22113|NCT02996175|"     The investigators long-term goal is to improve outcomes for children with Down syndrome (DS)     and their caregivers. Towards that goal, the investigators propose a randomized clinical     trial of a behavioral sleep treatment designed specifically for children with DS, documenting     the impact not only on sleep, but also on the child's daytime inhibitory control and behavior     problems, and the caregiver's sleep and stress levels. The investigators will randomize 80     families of children with DS ages 6-17 to receive either a 5-session behavioral sleep     treatment (BST; targeting sleep education, behavioral principles and visual supports) or a     general-education control condition (CON). The BST will cater to the unique needs of children     with DS, adapting an intervention that successfully treats behavioral sleep disturbances in     children with autism1. Pre- and post-intervention, children will undergo comprehensive     assessments of cognitive, behavioral, and adaptive functioning involving direct testing and     input from parents and teachers. Child and parent sleep will be monitored via actigraphy and     parent-completed sleep diaries, and parents will report on their stress levels and mood.   "
22114|NCT02996162|"     This is a prospective, longitudinal observational study to provide data regarding the natural     course of hypercapnia in premature infants with bronchopulmonary dysplasia using both     available blood pCO2 and measured capnography, as well as relate the degree and trend of     hypercapnia to later respiratory outcomes.   "
22115|NCT02996149|"     Endoscopic lung volume reduction coil treatment is a treatment option for selected patients     with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic     respiratory failure. In this observational study the safety and efficacy of endoscopic lung     volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is     evaluated.   "
22116|NCT02996136|"     The ARROW-FLU Influenza A&B Test is an in vitro diagnostic immuno-chromatographic assay     intended for the qualitative detection of influenza A and influenza B viral nucleoprotein     antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended     to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This     test is not intended for the detection of influenza C viruses. A negative test is presumptive     and it is recommended these results be confirmed by cell culture of an FDA cleared molecular     device. Negative results do not preclude influenza virus infection and should not be used as     the sole basis for treatment or other management decisions.   "
22117|NCT02996123|"     measuring difference in biting force between (computer aided design/computer aided     manufacturing) maxillary dentures and conventional ones.   "
22119|NCT02996097|"     The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser     therapy immediately followed by intralesional steroid therapy against intralesional steroid     therapy alone for the treatment of keloids.   "
22120|NCT02996084|"     The primary objective of this study is to determine the normative range of brain volume and     brain volume change in healthy control (HC) participants whose age, race, and gender     distribution is approximately matched to the age, race, and gender distribution of patients     with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use     the results of the primary endpoint to ensure consistency of brain volume measurements across     MS PATHS centers.   "
22121|NCT02996071|"     Bariatric surgery is an effective method for treatment of obesity. Sleeve gastrectomy is one     of surgical methods and became popular in recent years. Weight loss rates after bariatric     surgery differs among patients. The exact reason of this difference stays unclear. age,     nationality, difference between body composition and type of surgery may be in concern. waist     to height ratio has become popular recent years as an indicator of cardiomethabolic status.     in this study, investigation of the effect of waist to height ratio differences of patients     on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.   "
22122|NCT02996058|"     Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic     properties. Despite off-label administration, dexmedetomidine has found a niche in critically     ill mechanically ventilated neonates and infants because of its minimal effects on     respiratory function at sedative doses, facilitating early extubation and fast-track     postoperative care.   "
29274|NCT02902471|"     A study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans     syndrome in patients after bone marrow transplantation. The force oscillations technique will     be compared with classical spirometry.   "
22123|NCT02996045|"     The goal of the study is to determine whether clinical decision support (CDS) for radiology     affects the number, type, or appropriateness of targeted high-cost radiology imaging orders     (i.e. magnetic resonance (MR), computed tomography (CT), nuclear medicine (NM) and Positron     Emission Tomography (PET) scans). The CDS will be delivered to physicians in the Aurora     Health Care system. It will be delivered in Epic, an industry-standard electronic medical     record software, through ACR Select, which is a leading decision support tool based on the     American College of Radiology (ACR) Appropriateness Criteria (see     http://www.acr.org/Quality-Safety/Appropriateness-Criteria). The ACR Select tool rates     imaging orders on a scale of 1-9 with 1-3 labelled as 'usually not appropriate', 4-6 'May be     appropriate', and 7-9 'usually appropriate'.   "
22124|NCT02996032|"     This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can     predict patients at higher risk of readmission within 30 days of hospital discharge for     decompensated heart failure.   "
22125|NCT02996019|"     This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to     compare the PK of etrolizumab administered SC by AI (test device) or a PFS-NSD (reference     device) in healthy participants. The study will comprise a pilot cohort to estimate the     geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and     area under the concentration-time curve (AUC) to confirm or determine the sample size for the     pivotal cohort. The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from     hour 0 to the last measurable concentration (AUClast), and AUC extrapolated to infinity     (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by an     AI or PFS-NSD.   "
22126|NCT02996006|"     This observational study introduced an new advanced bleeding control strategy during complex     liver resection.This newly described stepwise vascular control technique was efficacious     and feasible to control intra-operative bleeding in complex hepatectomy involving second     hepatic hilum and retro-hepatic inferior vena cava.   "
22127|NCT02995993|"     Six patients with Fabry disease will be recruited. Patients will receive a single dose of 0.2     mg/kg recombinant human alpha-galactosidase A produced in moss (moss-aGal) as intravenous     infusion. Patients will be hospitalized during the infusion and for at least 24 hours after     the end of the infusion. Treatment will be administered sequentially: if a patient shows no     safety concerns on the treatment day, treatment of the next patient will commence on the     following day.   "
22128|NCT02995980|"     This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital     mammography to detect breast cancer in patients with increased breast density (BI-RADS     category c or d). Eligible patients will be invited to have full-field digital mammography     and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the     imaging methods for the detection of breast cancer.   "
22129|NCT02995967|"     The specific aim of this trial is to determine if hydrodistention at the time of     intradetrusor injection of botulinum toxin A has additional benefit in patients with     refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection     of botulinum toxin A alone.      Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5     minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A     (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone     (botulinum toxin A alone group).      The primary aim will be subjective improvement measured as change from baseline at 12 weeks     using the OAB-q bother subscale.   "
22130|NCT02995954|"     The introduction of fixed combination of ACEi+CCB (Fixed) has significantly increased     patients compliance and adherence to therapy. At the moment, however, there are no data     suggesting the better control of once-daily fixed (Fixed) over free doses in separate     administrations combination therapy in hypertensives.      In a population of 39 consecutive outpatient patients referred to the departmental     Hypertension clinic of the University Hospital of Salerno Medical School with the first     diagnosis of arterial hypertension, the investigators tested the hypothesis that the Fixed     achieve a better control of blood pressure than the Free combination. Patients were     randomized to either strategy and after 3 months patients underwent a clinical assessment to     evaluate the antihypertensive effect.   "
22131|NCT02995941|"     The purpose of this study is to examine the reliability and use of the shoulder symptom     irritability classification system for the purposes of determining an appropriate treatment     intensity to better help people with shoulder pain.   "
22132|NCT02995928|"     Decompressive craniectomy has been reported for the treatment of patients with aneurysmal     subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet been     undertaken to confirm its effect.The purpose of the study is to determine whether     decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will     improve clinical outcomes of poor-grade aSAH patients.   "
22133|NCT02995915|"     Alcohol misuse and smoking constitute two of the three leading preventable causes of death in     the United States. The purpose of this research study is to develop an intervention designed     to help people stop drinking alcohol and stop smoking at the same time.   "
22134|NCT02995902|"     The purpose of the study is to determine the value of FLT-PET early after initiated     chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the     brain should be performed routinely in these patients.   "
22135|NCT02995889|"     This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in     patients with irradiated lung cancer in comparison with FDG-PET/CT.   "
22136|NCT02995876|"     When missing tooth structure or teeth are replaced, minimal biologic risk should be involved     to re-establish function and esthetics. The increased use of the adhesive technique and     preservation of dental tissues have greatly impacted conservative tooth preparation design.     The development use of zirconia technology and all-ceramic systems has opened the potential     for fabrication inlays zirconia bridges with durability and good aesthetics.      The purpose of this study is to clinically evaluate the placement of inlay bridge made of a     Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive     approach in the replacement of a single missing tooth.   "
22137|NCT02995863|"     This research presents a randomized clinical trial which analyzes the efficacy of a rigid     rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot     patients. The hypothesis of the research is the use of a rigid rocker sole reduces the     recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.   "
22138|NCT02995850|"     This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy     and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic     intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy     combination in gastric cancer with peritoneal metastasis   "
22139|NCT02995837|"     Obstructive sleep apnea syndrome (OSAS) causes hypoxemia and hypercapnia, which may impair     cerebral blood flow and cause deficits in behavior. This is a case-control study designed to     investigate cerebral blood flow and neurocognitive function in children with OSAS when     compared to these findings from normal children. The study hypothesis is that children with     OSAS have an impaired cerebral blood flow during wakefulness and sleep compared to normal     controls, and that the degree of this impairment correlates with neurocognitive function.   "
22140|NCT02995824|"     This is a retrospective observational multicenter cohort study based on 271 consecutive     HIV-HCV coinfected patients who underwent liver transplantation (LT) between 2002 and 2012 in     23 centers from Spain and who were prospectively followed until January 2016. The main     objective of this study is to analyze the effectiveness and safety of 2 nucleoside reverse     transcriptase inhibitors (NRTIs) plus Raltegravir (RAL)- based antiretroviral therapy (ART)     compared to other antiretroviral regimens in liver transplant (LT) HIV-HCV co-infected     recipients. In addition, the investigators want to know the rejection rates in patients     taking RAL-based ART in comparison with other ART-regimens and to know the efficacy and     safety of direct antiviral agents (DAAs) against HCV in HIV-infected liver transplant     recipients taking RAL-based ART.   "
22141|NCT02995811|"     This study will identify the changes in different muscles of patients receiving     Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to Intensive     Care Unit (ICU). The information will help guide development of treatments such as exercise     that may help to reduce the amount of muscle wasting that can occur during critical illness.   "
22142|NCT02995798|"     Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the     cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April     2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year     (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any     destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral     mass. Patients were divided into three groups according to femoral neck BMD (Group A, T-score     ≥-1; Group B, -2.5<T-score<-1.0; Group C, T-score≤-2.5). Group A had normal BMD patients,     Group B had lower normal patients including osteopenic patients and Group C presented     osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral canal (cHU,     the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the     medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the     axial CT images in clinical images.   "
22143|NCT02995785|"     [Background and Objective]First-aid skill training plays an important role in the education     of nurses. How to implement stable and efficient skill is very important. (Kardong-Edgren,     Oermann, Odom-Maryon, & Ha, 2010). Simulation-based workshops,or training, as the most common     enhancing skills.(Topping et al., 2015) .This study was designed to assist nurses enhancing     the clinical ability and safety the patients in the first aid-related skills and knowledge.     The purpose of this study is to compare the two groups of(1) first aid knowledge online test.     (2) first aid skills test.【Methods】This study is a general ward nurses first aid technical     examination, pre-test and post-test, the random control trial. Review by the hospital ethics     committee and execution date on105/12/12-107/03/08, a total of 92 cases, obtained consent of     all cases, then the case will be test in our hospital clinical skills center. Subject     condition: general ward nurse (minimum age> 20 years),exclusion conditions: intensive care     unit nurses, emergency department nurses. Study Procedure: Subjects who obtained the informed     consent were randomly assigned to the first aid skill simulation training group (FAST) or the     traditional group (T) by using a computer generated number. Randomization envelopes were     opened and randomization performed by the study nurse after informed consent was obtained.     Each group consisted of 46 subjects. All the subjects were pre-test first aid knowledge     online test, followed were pre-test first aid skills test at the Clinical Skills Center.After     pre-test,the experimental group are give the first aid skill simulation training with     debriefing(75-min) and online lecture(15-min).While the traditional group only give online     lecture(15-min). Two weeks later, the post-test include online test and skills test for two     groups. After all the data were collected by the researchers who unknown the groups, the     names of the cases were removed and the scores of the two groups were compared before and     after.The test Based on 2015 AHA Guidelines for CPR & ECC (2015 Adult Basic Life Support and     Cardiopulmonary Resuscitation Quality & 2015American Heart Association and 2015).The data     will be archived in SPSS20.0 statistical package software. Statistical methods such as T-test     and Anova variance analysis are used to analyze the data【Expected Result】: The knowledge and     skills in the experimental group were better than the traditional group, and the first-aid     simulation skill training was helpful for the clinical emergency situations.   "
22144|NCT02995772|"     This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated     with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy     (NACT)   "
22145|NCT02995759|"     Data strongly suggests that aggressive and early treatment of status epilepticus (SE) is     crucial for seizure abortion and prevention of long-term neurologic sequelae. We propose the     creation of a seizure action plan, an intervention aimed to guide daily medication use,     outline pre-hospital seizure first aid and rescue medication use, and direct emergency     personnel in patients' individualized SE medication algorithm, with implementation through     the electronic medical record. We hypothesize that the seizure action plan will promote daily     medication adherence, increase use of home rescue mediation, and improve timeliness of AED     (antiepileptic drug) delivery, length of hospital stay, and ICU admission rate in episodes of     status epilepticus.   "
22146|NCT02995746|"     This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on     central macular thickness and visual acuity in those patients with persistent macular edema     after pars plana vitrectomy for epiretinal membrane.   "
22161|NCT02994732|"     The primary objective of this study is to characterize the metabolic disposition,     pharmacokinetics (PK), and routes of elimination of [14C]‑labeled BVD‑523 after     administration of a single, oral dose to healthy male subjects.      The secondary objective of this study is to evaluate the safety and tolerability of a single     oral dose of [14C]‑labeled BVD‑523 in healthy male subjects.   "
22162|NCT02994719|"     The purpose of this study is to investigate whether speed-dependent measures of gait can be     identified in patients with neurological conditions that affect gait, particularly in     subjects with parkinsonian disorders.   "
22259|NCT02994251|"     The study will be a single-center, single-arm, Phase II study of gemcitabine and cisplatin in     combination with conventional trans-arterial chemoembolization therapy in adult patients with     advanced ICC. 25 patients will be enrolled over the course of 2 years, with an additional 1.5     years for patient follow-up.   "
29275|NCT02902458|"     This study aims to investigate whether follow-up with a psychologist has an impact on the     outcome of patients with an implantable automated defibrillator.   "
22147|NCT02995733|"     Asthma imposes a significant burden in the US in terms of morbidity, costs to society,     individual suffering, loss of productivity and mortality. African Americans (AA) and     Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national     guidelines for asthma treatment, the gap between these groups and whites has been stable or     widening. The need for pragmatic research to address the continuing burden is widely     recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms.     Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to     prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis,     in all but the mildest asthma. However, adherence by patients and implementation of     evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests     that it is difficult to improve adherence to the current recommendations without complex and     resource-intensive interventions. Studies have examined symptom-activated use of ICS     triggered by use of a reliever medication. The Investigators call this approach PARTICS -     Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world     studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with     usual care, while reducing ICS use by half or more. These studies have been performed in     pre-selected populations, which represent less than 5% of asthma patients. The previous     studies have been done with repeated education and adherence checks in both the intervention     and control arms.      We have consulted with AA and H/L patients, health care providers, leaders of professional     societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical     manufacturers. All groups have indicated that asthma decision making would be changed if we     demonstrated that implementing PARTICS improves important asthma outcomes such as reducing     exacerbations. The Investigators have designed a study with the stakeholders to determine     whether PARTICS can improve outcomes that are important to patients when superimposed on a     background provider-educated standard of care through the Asthma IQ system. The Investigators     propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in     Highly Impacted Populations. The Investigators aim to determine whether PARTICS can reduce     asthma morbidity in AA and H/L. The primary outcome will be asthma exacerbations. The     secondary outcomes will include additional outcomes important to patients (i.e. days lost     from work or school, asthma control, & asthma quality of life). The study has broad input and     involvement from multiple stakeholder groups in study design, implementation, and commitments     for dissemination. AA and H/L patients and their advocates have been involved and will     continue to play a central role in all phases of the study.   "
22148|NCT02995720|"     An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare     the pharmacokinetics and safety between a fixed dose combination of     Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of     Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.   "
22151|NCT02995681|"     People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their     balance and a high incidence of falls compared to those of a similar age. Pulmonary     rehabilitation is recommended for people with COPD, however, these training programs do not     typically include balance training or fall prevention strategies. In this study, patients     with COPD who report problems with their balance or have had a fall in the last two years     will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or     control group (standard pulmonary rehabilitation). We will record the number of falls using     monthly diaries and evaluate patient's balance, strength, confidence and quality of life.   "
22152|NCT02995668|"     Knee osteoarthritis is one of the most common pathologies in old people, and the leading     cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility,     functional impairment and proprioceptive deficit. When conservative treatments fail to     control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly     because of its efficacy on pain relief. In recent decades, this surgical procedure has been     soared, and it has also aroused the interest of researches about the patients' outcomes after     surgery.      Despite the TKR results in good reported outcomes, after surgery patients may manifest     persistent pain and problems affecting to their functionality, stability, walking speed,     proprioception, motor control, risk of falling and therefore to their quality of life. In     more than a third of the cases, those deficiencies may be extended after surgery from six     months to one year, when subjects use to achieve the plateau functional values.      Traditional rehabilitation programs have been usually focused on improving muscle strength of     the lower limbs as well as the functionality with specific exercises to achieve this purpose,     and to a lesser extent on balance and proprioception exercises. Evidence supports this     approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one of the     most important factors for a complete rehabilitation, since benefits of proprioceptive and     balance trainings may range from better stability and motor control, improvements in both     static and dynamic balance and enhanced functionality. Indeed, recent studies have shown that     the combination of traditional functional rehabilitation together with balance training may     help to restore functional deficits to a larger extent than usual therapy, and based on a     systematic review published (Moutzori, 2015) and in our previous works (Roig, 2016),     sensori-motor training is an acceptable adjust to usual physiotherapy care .      Looking into the effect of preoperative trainings or education before TKR surgery, it is     aimed at improving the physical function, but also managing the expectations of the surgery     for a better recovery. There is from low to moderate evidence about the effects of TKR     pre-interventional training programs, and some authors have argued that the effects are too     small to be consider clinically relevant.      In general, the preoperative program is usually focused on functional and strengthening     exercises. Despite of proprioception is used in the clinical practice for the prevention and     recovery of many orthopedics injuries, the amount of evidence about the effects of     proprioceptive training programs for knee and hip replacement is not large, few works     compares pre-habilitation and post-rehabilitation programs, and there is not systematically     reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional     training programs.      In this framework, this aimed at evaluating the effects of specific-task oriented     proprioceptive and balance training programs when conducted by patients undergoing TKR before     and after surgery, and will compare these effects to the outcomes achieved with traditional     strength-functional programs, as well as to no specific prehabilitation training.   "
22153|NCT02995655|"     The investigators hypothesize that CX-01 will disrupt the bone marrow microenvironment and     increase the cytotoxic effects of azacitidine on myelodysplastic syndrome (MDS) and acute     myeloid leukemia (AML) hematopoietic stem cells by disrupting the High-mobility group box     protein 1 (HMGB1) interaction with toll-like receptor 4 (TLR4) and receptors for advanced     glycation end products (RAGE), the CXC chemokine CXCL12/chemokine receptor 4 (CXCR4) axis,     and by disrupting other leukocyte and vascular adhesion molecules. In addition, CX-01 may     also help promote count recovery after treatment given its affinity for platelet factor-4     (PF4).      The selection of CX-01 dose for study in relapsed or refractory MDS and AML has been based     upon the dual requirements to have sufficient drug administered to have potential activity     but without clinically significant anticoagulation. The study dose chosen (4 mg/kg bolus     followed by 0.25 mg/kg/hour) fulfills both of these criteria. In addition, this dose is     expected to result in serum levels of CX-01 which are significantly higher than the IC90     identified in preclinical studies for inhibition of HMGB1-RAGE, toll-like receptor 2 (TLR2)     and TLR4 interaction. Therefore, the chosen dose represents a rational balance between     effective dosing and safety in thrombocytopenic patients with MDS and AML. This dose was     previously established to be safe and tolerable when combined with cytarabine and idarubicin     in patients with AML.   "
22154|NCT02995642|"     Stroke and abdominal aortic aneurysms (AAAs) are common and highly lethal vascular diseases.     Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and     AAAs.      The purpose of this study is to test PET/CT and PET/MRI imaging to specifically detect those     diseases using a new developed agent (18F-FPPRGD2) that can target angiogenesis and     macrophages.   "
22155|NCT02995629|"     Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser     to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat     patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required to     achieve gray-white retinal burns and duration of treatment.   "
22156|NCT02995616|"     The aim of this study will be to investigate the energy consumption, cardiorespiratory load     and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted     gait training (RAGT) session and to compare the exercise intensity with aerobic training     recommendations.      The second aim is to investigate the effect of different levels of guidance force on the     energy consumption, cardiorespiratory load and perceived exertion.   "
22157|NCT02994784|"     This is a single arm, open label study designed to evaluate the safety and efficacy of     propylene glycol-free melphalan hydrochloride in patients with AL amyloidosis. Treatment will     be comprised of propylene glycol-free melphalan hydrochloride administered intravenously at a     dose of 70-100 mg/m2/day on Days -3 and -2 as conditioning prior to autologous stem cell     transplantation.   "
22158|NCT02994771|"     Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast     Cancer.      Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin®     in patients with secondary lymphedema associated with the treatment of breast cancer.   "
22163|NCT02994706|"     Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing     recurrent chest infections and premature death due to lung failure. When patients develop     chest infections their symptoms usually slowly worsen over the course of several days to     weeks. Due to this gradual onset, patients often seek medical attention several days or weeks     after symptoms start to worsen. The Investigators believe that if they were able to monitor     patients more closely they could diagnose and treat chest infections earlier and consequently     improve health outcomes.      The HOMECF study aims to investigate whether home monitoring is beneficial for adults with     CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive     routine clinical care for 12 months. Subjects receiving home monitoring will measure their     lung function and symptoms twice weekly and this data will be transmitted to the medical team     by means of a modified mobile phone.      the Investigators hypothesize that home monitoring will allow them to diagnose chest     infections at an earlier stage and reduce hospital inpatient days. They will also assess the     subjects' experience of receiving home monitoring, the impact on body weight and lung     function and and conduct a full health economic analysis to assess value for money. They will     also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels     of inflammatory markers.      Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research     team are well placed to carry out the study because it is a large regional adult CF centre     with an excellent record of conducting clinical research.   "
22164|NCT02994693|"     The goal of this research is to determine the natural history of Barrett's esophagus (BE)     using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.   "
22165|NCT02994680|"     The purpose of this randomized controlled field trial is to determine whether a liquefied     petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen     exposure to household air pollutants and improves cardiopulmonary health outcomes when     compared to usual cooking practices with open-fire biomass-burning stoves in adult women aged     25-64 years.   "
22166|NCT02994667|"     The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in     patients undergoing permanent pacemaker placement after TAVR.      As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular     conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing     permanent pacemaker placement after TAVR.   "
26741|NCT02935686|"     The primary purpose of this study is to assess safety/tolerability of the different vaccine     regimens and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different     vaccine regimens.   "
22167|NCT02994654|"     The overall purpose of this is study to provide continued access to the ReCell device     following completion of protocol CTP001-6, and allow for collection of supplementary clinical     outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with     acute thermal burn injuries who require skin grafting for closure of burn injuries.   "
22168|NCT02995590|"     Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic     Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively     measuring physiological lung deformation on a regional basis. This unique imaging technique     holds great promise for assessing, validating, and improving the use of Deformable image     Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas     tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for     the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this     application is to optimize the hyperpolarized helium tagging MRI technology and establish its     usefulness for DIR assessment.      Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D)     hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung     deformation between inhalation and exhalation. Our second objective is to develop     physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy     subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be     used to evaluate a range different DIR algorithms, by comparing the errors between the     DIR-derived deformation vector fields and the ground truth represented in the digital     phantom. Successful completion of these aims will yield a novel methodology for DIR     assessment in the lung for radiotherapy.   "
22169|NCT02995577|"     The purpose of this study is to investigates serum and stool biomarkers as predictors for     post-operative feeding intolerance in infant patients with complex congenital heart defects     who undergo single ventricle staged palliation surgery.   "
22170|NCT02995564|"     This study is investigating the development of a social skills training program for adults     with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal     Investigator for this study is Dr. Michael Murray, the director of the Autism Studies     Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a     social skills training program to address and enhance the social skills of adults with     Asperger's Syndrome and high-functioning autism.   "
22171|NCT02995551|"     There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can     be caused by either a smaller or larger trauma or be a degenerative age-related tear.     Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality     studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40     years or younger) in comparison to non-surgical treatments.      The purpose of this study is to determine if a strategy of early arthroscopic meniscal     surgery (repair or resection) is superior to a strategy of initial individualized supervised     exercise therapy including patient education with the option of later surgery if needed in     improving pain, function and quality of life in young patients (18-40 years) with meniscal     tears.      The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve     more than patients treated with exercise and education.   "
22172|NCT02995538|"     The objective of this project is to develop a Neurogenetics patient database and bio     repository - which includes clinical information regarding history, physical examination,     laboratory testing including genetic testing (NextGen sequencing including whole exome and     whole genome sequencing, SNParray, etc.), neuroradiology studies, neurophysiology studies -     all ordered as clinically deemed appropriate, natural history from clinical longitudinal     follow-up and to use de-identified information from this registry/ repository, when     appropriate for clinical and translational research.   "
22260|NCT02994238|"     The goal of this study is to determine whether a sensor-enabled, clinically integrated,     mobile health asthma program can improve asthma outcomes among 4-11 year old children with     moderate-to-severe asthma.   "
22173|NCT02995525|"     The aim of this epidemiologic prospective study is to determine the prevalence of CPSP     defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10     point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.      The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant     thoracic surgery in children aged 6 to 18 years.      The secondary objectives: the intensity of chronic post surgical pain, the prevalence of     neuropathic syndrome and the predictive risk factors.   "
22174|NCT02995512|"     The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine     in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts     its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing     the expression of adhesion molecules responsible for their recruitment in MI.   "
22175|NCT02995499|"     The ASA-PS classification, a subjective classification system of the patients' preoperative     health status, contains a certain problem concerning its interrater reliability. A comparison     between anesthesiologic and surgical assessment of the preoperative patient condition has not     yet been extensively investigated. The aim of this study is to examine the latter in a     prospective, monocentric, observational study.   "
22186|NCT02995343|"     Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated     in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes,     antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will     search their archives for finding suitable patients for study. Investigators will especially     notice being at least 6 month time of interval between surgery and evaluation time.     Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of     menstrual cycle. These results will be compared with normal postpartum women's results. It     will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine     arteries on ovarian reserve   "
22187|NCT02995330|"     Men with progressive metastatic Castration-Resistant Prostate Cancer post first-line     treatment with either androgen deprivation therapy alone or androgen deprivation therapy plus     docetaxel who have an identified related female donor (mother sister, daughter, second degree     relative such as granddaughter or niece) will undergo bone marrow transplantation followed by     post-transplant Cytoxan (PT/Cy) and testosterone.   "
22176|NCT02995486|"     A randomized, control trial will be conducted to evaluate the effects of a post-discharge     falls prevention program in patients with neurological diseases and disorders. The objective     of this study is to evaluate if implementing a falls prevention program is effective in     reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance     in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center     will be randomized on the day of discharge to receive an exercise falls prevention program,     delivered by Baptist Health physical therapists, or an educational pamphlet on falls     prevention. Baseline and follow up assessments for gait, balance, and strength will be     completed at regular intervals to examine effects of the exercise program. In addition,     participants will be surveyed to find out about recent falls and hospitalizations. This is a     minimal risk study such that the assessments involve conditions in which subjects likely     encounter on a daily basis. The risks of the exercise intervention also are no more than one     might expect from a community exercise program. Potential benefits include reduced     hospitalizations and/or emergency visits related to falls in the intervention group,     increased activity levels and improved falls efficacy in the intervention group, and     increased system capacity at Baptist Health to deliver a falls prevention program.   "
22177|NCT02995473|"     This study is to evaluate the efficacy and safety of topical application of NP000888 ointment     compared to vehicle in plaque and fingernail psoriasis subjects.      Duration of administration: 24 weeks   "
22178|NCT02995460|"     Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced     physical function. Patients have a higher risk of cardiovascular disease and a higher body     mass index.      A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation     after 12 weeks of high-intensity interval training.      The primary aim of this study is to determine whether high-intensity interval training     affects the disease activity in psoriatic arthritis. This intervention is believed to result     in benefits in terms of inflammation, body composition and risk factors for cardiovascular     disease.   "
22179|NCT02995447|"     The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison     between scalp and intracerebral electrodes   "
22180|NCT02995434|"     This study seeks to explore the efficacy of virtual reality (VR) experiences as a practical     adjunctive therapeutic intervention in the self-management of the chronic pain associated     with cancer survival. A comparative controlled interventional trial and qualitative     interpretative-descriptive exploration will be undertaken with 100 Cancer survivors who are     experiencing chronic pain. Participants will be randomly assigned to either a virtual reality     (VR) therapy group or an immersive multimedia control group (50 subjects in each).      They will undertake either a series of virtual reality interventions, or 2D multimedia     control sessions in their own homes over a period of a month. The intervention will be used     daily for a month to enable customization to the therapy and record data over a long enough     period of time to account for any individual short-term changes in pain.      The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore     interactive immersive environments. The control group will be exposed to similar 2D computer     based multimedia experiences (without a VR headset) that on home computers. Pre during, and     post pain test scores and quality of sleep assessments will be recorded using standardized     tools.      At the end of the study, ten of the subjects who demonstrated the most improvement in their     pain using the VR expereince will be selected and invited to explore for any measurable     changes in neurological activity using pre and post exposure MRI studies.   "
22181|NCT02995408|"     This study has three aims:      Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and     parents with children with ASD, this study aims to identify the psychosocial needs of parents     of children with ASD, specifically a) the types of concerns that parents find most difficult     and stressful b) areas of concern that lack support and resources, and c) areas of need for     education and skill training. This study also aims to gather feedback on the Benson-Henry     Institute's Relaxation Response Resiliency Program (3RP).      Phase II: Informed by Phase I findings, this study aims to develop and determine the     feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)     program for parents of children with ASD.      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,     establishing efficacy of a virtual resiliency program.   "
22182|NCT02995395|"     This study will evaluate the role the balloon mucosal impedance may have in diagnosing and     monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the     balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.   "
22183|NCT02995382|"     This study aims to determine the Health Related Quality of life (HRQOL) (the physical,     mental, emotional and social functioning) of patients with cubital tunnel syndrome following     anterior intramuscular transposition, after one year.   "
22184|NCT02995369|"     The goals of this study are to determine if 1) placement times of pit and fissure sealants     using the DryShield system differ from those when using the cotton roll isolation technique;     and 2) there is a significant difference in patient preference between Dryshield and the     cotton roll technique.   "
22185|NCT02995356|"     Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients     will be determined with using irregular increased human chorionic gonadotropin (beta-HCG)     results and no embryo reported ultrasonography results. Plasma and cervical fluid samples     will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase     levels of samples will be compared between patients who have doubt for ectopic pregnancy and     patients who have intrauterine pregnancy. Concentration of these proteins in samples will be     evaluated. If any difference will be found between groups in favour of ectopic pregnancy,     these results might be interpreted as these proteins useful for early detecting of the     ectopic pregnancy.   "
22188|NCT02995317|"     The purpose of this study is to investigate if the level of physical activity, selected     physical and psychological risk factors can predict risk of falling in older (≥65) community     dwellers.   "
22227|NCT02994810|"     The benefits of breastfeeding are increasingly known of the population and breastfeeding     rates in the country have been increasing, but still are below satisfactory to the Ministry     of Health (MH) and the World Health Organization (WHO).      Simple Strategies to guide and support the mother contributes to increasing knowledge about     breastfeeding and can have positive impacts on breastfeeding rates.   "
22189|NCT02995304|"     In this double blind study, after taking an informed consent, 60 children aged between 7 and     12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly     divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV     followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In     the second group30 children who will receive the same dose of midazolam followed by saline     premedication. All groups will be compared for pain score using visual analog scale (VAS)     after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood     pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication, every     10 min after premedication then every 5 min during and after anesthesia. 6 point sedation     score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point     wake-up score will be recorded every 5 min. Time of first analgesic requirement and total     morphine consumption during the first post-operative 8 hours will be recorded.   "
22190|NCT02995291|"     Clinical trials have shown phentolamine mesylate (PM), brand name OraVerse, to be effective     at reducing the amount of time to reversal of local anesthesia with different dental     anesthetics. However, to date no study investigated the efficacy of phentolamine mesylate to     reverse anesthesia induced with the use of Bupivacaine.      The objective of the proposed research is to conduct a pilot-scale randomized clinical trial     evaluating the difference in time required for the return of normal soft-tissue sensation and     function in participants who have received 0.5% Bupivacaine HCl, 1:200,000 epinephrine,     followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile     physiological water (control).   "
22191|NCT02995278|"     The purpose of this minimal risk, observational survey is to document the accuracy, benefits,     and how qualitative and quantitative results affect patients' plan of care.   "
22192|NCT02995265|"     To determine the effect of using a robotic exoskeleton to allow walking practice after     stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary     outcomes.   "
22193|NCT02995252|"     This is an observational, longitudinal, prospective study for sample collection and     evaluation for future therapy or disease progression of chronic hepatitis B and C.     Participants will be seen on an annual basis with optional additional visits for up to 10     years and provide samples for research and evaluation of disease progression. In addition,     there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of     treatment with tenofovir alafenamide and blood collections with optional liver biopsies.   "
22194|NCT02995239|"     To compare the pharmacokinetics after administration of different formulation of CJ-12420   "
22195|NCT02995226|"     The purpose of this study is to check if patients, but also relatives (as they share familial     and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant     physical effort (doing too much) compared to healthy controls, and if physical efforts are     participating to core symptoms of anorexia nervosa, such as more appetite (instead of less),     less pain, more abnormal body image, and less cognitive flexibility.      Such a result could help to further understand the role of difficulties with physical     exercise as part of the phenotype of anorexia nervosa.   "
22196|NCT02995213|"     The investigators are proposing a pilot study, the purpose of which is to use accelerometers     to quantify UE use (1 and two hand use) in people post-stroke from which the investigators     will develop use-based feedback to improve recovery in the home setting. The objectives of     this pilot study are to:      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the     home setting in individuals chronic post-stroke,      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger     (non-paretic) UEs, and      iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on     unilateral and bilateral UE use.      iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally     in subjects post-chronic stroke pre and post feedback.   "
22284|NCT02993926|"     The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the     treatment of Central Precocious Puberty (CPP) in Chinese participants.   "
22285|NCT02993913|"     Phase I dose escalating trial. Primary objectives of this study are to assess the safety and     tolerability of Simmiparib following single and multiple oral doses in patients with advanced     solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting toxicity     (DLT), and pharmacokinetic profile.      The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.   "
22197|NCT02995200|"     A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two     hand use) in healthy controls and people post-stroke from which the investigators will     develop use-based feedback to improve recovery in the home setting. The objectives of this     pilot study are to:      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the     home setting in healthy individuals and individuals chronic post-stroke,      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger     (non-paretic) UEs,      iii.) quantify and compare amount of UE use in healthy controls to that of people chronic     post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and      iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on     unilateral and bilateral UE use.      v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between     healthy controls and subjects post-chronic stroke pre and post feedback (for the people after     stroke).   "
22198|NCT02995187|"     This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial     evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients     with small cell lung cancer.   "
22199|NCT02995174|"     Contrast balanced dichoptic videogame training has been found to improve sensory functions in     adults with amblyopia; best corrected distance visual acuity (BCVA) and stereopsis, but its     effect on motor function, namely amblyopic eye fixation stability, is unknown. Furthermore,     the effect of treatment in cases of mild amblyopia is not well understood. The aim of this     study is to find out the difference on fixation stability, BCVA and stereopsis in mild     amblyopes after 6 weeks' contrast balanced dichoptic video game training.   "
22200|NCT02995161|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
22201|NCT02995148|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
22202|NCT02995135|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
22205|NCT02995096|"     Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an     important cause of mortality for this surgical population. In addition to tumor     characteristics, It has been suggested that pre-treatment and sirolimus-based     immunosuppression may affect recurrence and survival. With data from the European Liver     Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of     tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival     after liver transplantation for HCC.   "
22206|NCT02995083|"     To investigate the clinical benefit of intra-articular injections of saline in patients with     symptomatic osteoarthritis of the knee and compare the clinical response of saline to the     current standard treatment with corticosteroids and an air injection placebo.   "
22207|NCT02995070|"     The aim of this study is to evaluate the influence of therapy with low-intensity laser     technique associated with connective tissue graft for root coverage in smokers and compare     the results with non- smokers   "
22208|NCT02995057|"     Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of     humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety     in patients. An alternative drug and vaccine delivery method is the use of hollow     microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and     bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a     result, they are better received by patients and do not induce needle anxiety. As the     investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel,     the purpose of this study is to observe their biocompatibility and inertness.   "
22209|NCT02995044|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
22210|NCT02995031|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
22211|NCT02995018|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
22212|NCT02995005|"     Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of     transmission in most high and intermediate HBV endemic areas, despite existing WHO     immunoprophylaxis recommendations. This immunoprophylaxis regimen, if given optimally, can     prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires     administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours of     birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states,     …owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in     most settings. Clearly, global control of HBV transmission will require improved MTCT     prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy     will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without     HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF),     an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency     against hepatitis B and its safety record in pregnant women. A randomized, controlled     clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant     women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg.     However, before embarking on a RCT, several critical knowledge gaps need to be addressed     including the ideal timing for TDF initiation. The purpose of this proposal is to address     these knowledge gaps.   "
22213|NCT02994992|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
22253|NCT02994329|"     This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of     oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of     home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV     status among the general adult and adolescent population.      The primary outcome of the trial is the proportion of individuals who know their HIV status,     defined as a self-report of being HIV positive or accepting testing (standard or self     testing) from the CHW.      Embedded within the impact evaluation is a process evaluation that will explore the fidelity     of the implementation of the intervention and outputs of the intervention. Qualitative data     on actual use, management and disposal of the HIVST kits, acceptability of HIVST and any     impacts on relationships (including between couples and with CHW) associated with use of     HIVST kits.   "
22214|NCT02994979|"     Delirium is an acute confusion that occurs in one third of hospitalized older adults. As     compared to those without delirium, hospitalized patients with delirium have longer hospital     stays, higher mortality, and increased risk of nursing home utilization. Substantial     attention has been paid to developing, testing, and disseminating interventions to prevent     delirium in the hospital but, to date, not in the nursing home setting. In a previous study     we used known information on delirium risk factors to develop an intervention that can be     delivered at onset of acute illness in nursing home patients. The current study is designed     to test the effect of this intervention in a single-site clinical trial. Objectives: 1) to     determine, as compared to control, the effect of a multicomponent intervention targeting     delirium risk factors on delirium frequency, delirium severity, cognitive and physical     function decline, and hospitalization in nursing home patients with acute illness, and 2) to     identify features of the intervention associated with occurrence of delirium and other     outcomes. Approach: We will screen nursing home patients on 17 long-term care units at a     large, urban nursing home who experience onset of a change in condition according to     established criteria, and enroll and assign them to intervention or control in a 1:1 ratio.     Those assigned to intervention will receive daily visits from an Elder Life Specialist, a     mobile Certified Nursing Assistant trained to provide services to counter risks for delirium,     including dehydration, immobility, cognitive impairment, undernutrition, and sleep problems,     for the duration of the acute illness and for 1 week following. Patients assigned to control     will receive usual care from the unit-based nurses and the patient's primary team. Delirium     will be assessed 5 days a week by a research assistant. Cognitive and physical function     decline and hospital transfer will be ascertained during a 1 month follow-up period. We will     compare outcomes between intervention and control, as well as examine associations between     outcomes and intervention features such as number and duration of visits.   "
22228|NCT02994797|"     Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow     patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study     the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients     with sicca syndrome and pSS.   "
22229|NCT02994641|"     In the surgical intensive care unit (SICU), goals of critical care are often discussed in     long-term ventilated patients around the time of extubation. Muscle weakness predicts     extubation failure but formal muscle strength assessment by the Medical Research Council     scale is time-consuming and not part of the daily clinical exam. In this observational study,     we hypothesize that COMA measurement, routinely used by the SICU nurses, is a reliable and     valid predictor for patients' SICU outcomes. This prospective observational study is carried     out within a consecutively enrolled cohort of adult patients who are extubated in two SICUs     at Massachusetts General Hospital, Boston.   "
22215|NCT02994966|"     In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care     as one of three significant targets for pan-provincial action. The Diabetes Foot Care     Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment     of foot ulcers in an effort to reduce lower limb amputation (LLA) by 50%. The DFCCPP key     deliverables apply consistency in assessment, care, treatment and process standards, early     intervention and complex wound care management, while optimizing health outcomes. To achieve     these deliverables, High Risk Foot Teams (HRFTs) will be implemented across the province     starting with three pilot sites (Slave Lake, Brooks, and outpatient clinics at the Peter     Lougheed Hospital). The pilot site facilities were selected on the basis of their employing     staff with expertise and knowledge in diabetic foot care. The HRFT will assess and treat     patients with moderate and high-risk findings, and this care pathway will then be rolled out     to all clinicians who perform diabetic foot assessments (Primary Care, Home Care, Diabetes     Centers, First Nations Reserves, etc.). In conjunction with the DFCCPP, we will evaluate the     efficacy of a technological device developed by Alberta-based small-medium enterprise (SME)     to improve diabetic foot outcomes by preventing future wounds in high-risk patients who have     recently been treated for active foot ulcers. This technology is the SurroSense Rx® smart     insole system (Orpyx Medical Technologies Inc., Calgary AB), a device that provides dynamic     offloading guidance to patients, in addition to enabling ongoing adherence tracking by the     HRFT. It is hypothesized that early wound detection and treatment will ultimately lead to     improvements in wound prevalence, chronic wound care, and reduce the need for surgical     intervention, including LLA.   "
22217|NCT02994940|"     Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical     patients. The drug is available in an over the counter, inexpensive oral form as well as a     considerably more expensive intravenous form. This study will compare opioid requirements and     acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus     intravenous routes given pre operatively.   "
22218|NCT02994927|"     The aim of the trial is to assess the safety and efficacy of the orally-administered,     selective complement C5a receptor inhibitor CCX168 (avacopan) in inducing and sustaining     remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis     (AAV).   "
22219|NCT02994914|"     This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental     Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale,     Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and  timed get up     and go  tests) for elderly breast cancer patients. The score obtained at this evaluation     will determine the radiotherapy scheme.   "
22220|NCT02994901|"     The goal of this cross-sectional study is to evaluate the difference in cytokine profiling     approach and mitochondrial function between geriatric sarcopenic patients (group 1) and     geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.   "
22221|NCT02994888|"     PROSPECT-C is a phase II study investigating the molecular markers of response or resistance     to anti-epidermal growth factor receptor (EGFR) antibodies.   "
22222|NCT02994875|"     The objective of this research is to identify the functional neural mechanisms (as assessed     using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained     individuals with cocaine dependence.   "
22223|NCT02994862|"     In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla     chinensis before Bonding of laminate veneers with adhesive resin cement provide better     survival rate than conventional Bonding method   "
22254|NCT02994316|"     Children with diabetic ketoacidosis risk neurological complications such as cerebral edema     with high morbidity. To prevent cerebral edema, it is essential to control correction of     hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic     ketoacidosis don't always permit an optimal care.      Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.      Therefore, monitoring of plasma copeptin levels could be of interest in children with     diabetic ketoacidosis and risk of sévère neurological complications.   "
22298|NCT02993744|"     It is the aim of this study to detect the effect of Betamethasone on the maternal     inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under     threat of preterm delivery, for example because of a cervical infection.   "
22299|NCT02993731|"     This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly     nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult     patients with Metastatic Pancreatic Ductal Adenocarcinoma.   "
22224|NCT02994849|"     Premature babies, born several weeks before their due date, are often very ill in the first     weeks and months of life, compared with those born at full term. Because babies' brains and     bodies are still developing at this time, early birth puts them at increased risk of later     problems with health and development. It is important to do everything possible to try to     improve the overall health of these children. Not only will this help children and families,     but it will also help to understand the correct amount and type of care they will need from     the NHS in the future. At present, England has three types of neonatal units: Neonatal     Intensive care units (NICUs) that can care for the most sick and most premature babies, Local     Neonatal Units (LNUs) that generally care for slightly less sick babies, and Special Care     baby units (SCBU) that care for larger premature babies who are generally well, but need time     to grow and develop before going home.      For those premature babies born between 27 and 31 weeks of pregnancy, there is no information     on whether they benefit from being looked after in one type of unit or another. At present     there is no guidance, so these babies may be looked after in either LNUs or NICUs. Babies who     are born at this stage of pregnancy cannot be looked after in a SCBU and sometimes need to be     moved after birth to either a NICU or LNU. There are 84 LNUs and 45 NICUs in England. In     2014, about half of these babies were cared for in a NICU and half in a LNU. There is the     need to know whether babies born between 27 and 31 weeks are best cared for in a NICU or LNU     or if it does not matter.      The main things that control where a baby is born are where the mother has her antenatal     care, and where there is a cot available for the baby. A mother may have antenatal care in a     hospital that has a NICU, LNU or SCBU. Because it is difficult to predict which mother is     going to have her baby early, she cannot be directed, at the time of her choosing her     hospital for antenatal care, where to go to for care. There is uncertainty before birth which     baby is likely to require intensive care, but usually the less mature babies need more     intensive care.      In this study to find out where it is best to care for babies born at 27-31 weeks of     pregnancy, the study will look at which type of unit: a) leads to the best outcome for babies     born at each week of pregnancy in this range; b) is most cost-effective for families and the     NHS and c) best considers views and needs of parents and staff caring for babies.   "
22225|NCT02994836|"     This study will be a multicentre prospective randomized trial to assess the percentage of     patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission     at one year compared to those in which the treatment is continued at stable doses   "
22226|NCT02994823|"     The investigators compared a pooled mother's expressed breastmilk for 24 hours with     individual pump session collection of milk to provide a more consistent caloric product     without increasing bacterial contamination.   "
22230|NCT02994628|"     In a previous study at the Appalachian State University (ASU) Human Performance Laboratory at     the North Carolina Research Campus (NCRC), investigators showed that cyclists ingesting about     one-half of a banana with water every 15 minutes cycled 75-km faster (5%) than with water     alone. The polyphenols (i.e., chemicals in plants with health benefits) in the banana     improved the capacity to counter oxidative stress, and the sugars lowered post-exercise     inflammation. The cyclists reported some gastrointestinal discomfort, however, from the high     volume of bananas consumed. Dole Foods, the sponsor of this study, has a banana collection     that includes many different varieties, including the Mini banana that has a higher sugar     (50%) and phenolic (63%) content than the typical banana (Cavendish) available in stores.     Thus athletes should experience similar performance benefits from a smaller volume of Mini     compared to Cavendish bananas, and reduced gastrointestinal symptoms. If study results are     favorable, Dole Foods may market the Mini banana as the sport banana.      The purpose of this study is to compare ingestion of Mini and Cavendish bananas with an     equicaloric, sugar-only beverage or water on 75-km cycling performance and post-exercise     oxidative capacity and stress, inflammation, immune function, muscle damage and soreness, and     gastrointestinal symptoms.   "
22231|NCT02994615|"     Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be     assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter     monitor.   "
22232|NCT02994602|"     This is a two-center, open-label study conducted in healthy male and female volunteers at two     academic research centers. The study will consist of three single applications of the     Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male     participants followed 2 hours later by supervised skin contact by the non-dosed female     participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing     Barrier to the Application will be assessed.   "
22233|NCT02994589|"     The investigators objective is to compare OASIS wound matrix with other commonly used     dressings available for the donor site in split thickness skin grafting in order to determine     which dressing provides the best outcome based on pain level, time to healing and aesthetic     outcome.   "
22255|NCT02994303|"     In patients with Fabry disease, this research study explores the presence of podocytes in     their urine as a potential non-invasive biomarker for baseline kidney disease; and explores     changes in the quantity of podocytes in their urine over time as a predictor for kidney     disease progression. To accomplish this, the investigators will evaluate the quantification     of podocytes in the urine of Fabry disease patients at baseline and longitudinally over time.     This study requires a single patient visit, during which the patient provides a urine     specimen. The research team will then collect the patient's kidney function data proximate to     the time of urine collection, and follow the patient's kidney function data longitudinally     over the five years of this study by reviewing their medical charts. The study offers no     interventions.   "
22300|NCT02993718|"     Under the hypothesis that dexmedetomidine sedation would result in less upper airway     obstruction, we evaluated the occurrence of upper airway collapse or the requirement of     airway intervention in patients with obstructive sleep apnea during dexmedetomidine or     propofol sedation.   "
22234|NCT02994576|"     Based on the efficacy of immunotherapies in advanced disease with a reasonable safety     profile/tolerability we could hypothetisize that, immunotherapy should work best in the     situation of minimal residual disease, Two clinical trials are ongoing to test the role of     immunotherapeutic agents in the adjuvant setting: PEARLS trial, a randomized phase III trial     with anti-PD1 monoclonal antibody pembrolizumab (MK-3475 or pembrolizumab) versus placebo for     patients with early stage NSCLC after resection and completion of standard adjuvant therapy,     and the second randomized phase III trial (NCT02273375) will evaluate the efficacy of an     anti-PD-L1 (MEDI 4736) for a maximum of 12 months versus placebo as adjuvant therapy in     completed resected stage IB-IIIA NSCLC and completed standard ACT.      The role of immunotherapeutic approaches for NSCLC in the neoadjuvant setting is currently     unknown. However, based on the survival efficacy of immunotherapeutic strategies in advanced     NSCLC where the tumor has not been removed which could produce higher immunogenicity and     based on the efficacy of neoadjuvant treatments in NSCLC, we propose to test the safety and     efficacy of atezolizumab as neoadjuvant therapy in subjects diagnosed with stage IB, II, or     IIIA (non N2) NSCLC and who are deemed suitable for surgical resection.      Clinical staging of NSCLC is based on computed tomography (CT) of the chest and upper     abdomen, brain CT or magnetic resonance imaging and 18F-FDG PETscan to rule out metastatic     disease and assess the potential for curative-intent resection. Adjuvant chemotherapy will be     performed according the standard clinical guidelines.   "
22235|NCT02994563|"     Prospective, single-arm, open label, Safety and Performance clinical investigation.   "
22236|NCT02994550|"     The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation   "
22237|NCT02994537|"     The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory     and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH).     At phase 1, the investigators focus on studying of the clinical characteristics of acute     autoimmune hepatitis, and then will study the difference about treatment effects between     acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that drug     induced AIH have some special characteristics that may be beneficial to distinguish it with     durg induced liver disease. Therefore the investigators will do some studies about drug     induced AIH or other disease which maybe related to the onset of AIH.   "
22238|NCT02994524|"     .Rerouting operation takes the advantage of minimal recurrence rate as well as minimal     incontinence that is associated with less sphincter division,It is indicated in patients with     transsphincteric fistula in whom lay open is expected to be associated with significant     incontinence .   "
22239|NCT02994511|"     This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive     factor of response/resistance to anticancer treatment. The project will involve the     collection and study of the archived tumour tissue where available (mandatory), serial blood     samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an     early phase clinical trial.   "
24355|NCT02966873|"     This is a randomized controlled Phase II clinical trial designed to evaluate the effects of     N-acetylcysteine (NAC) in reducing Alcohol Use Disorder (AUD) severity and Post Traumatic     Stress Disorder (PTSD) symptomatology among individuals with current AUD and PTSD.   "
22240|NCT02994498|"     The primary study objectives are        1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the          maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects          with advanced melanoma (Phase I)        2. to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on          therapy to dacarbazine in subjects with advanced melanoma in terms of progression free          survival (Phase IIa)   "
22241|NCT02994485|"     Portal hypertension is not a disease in itself. Rather, it is an indication of an illness,     caused mostly by chronic lesions of the liver because of distinct causes, such as viral     infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic     vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal     hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by     more than 5 mm Hg.   "
22242|NCT02994472|"     The Investigators institution has used a meal consisting of mashed potato, peas and Beanfeast     (soya mince) for gastric emptying studies for a number of decades. Validation of the study     method was purportedly performed when the study was first implemented at the hospital,     however no historical data has been found. The current normal ranges are also     unsubstantiated. There is scientific justification for this research because in vivo studies     are instrumental to the validation of a new procedure. There is a need for a meal preparation     that is palatable and meets dietary requirements (vegetarian, gluten free e.t.c.) of patients     as the diagnosis depends on ingestion of the radiolabelled meal. In addition, reliable normal     ranges will ensure that the clinical diagnosis is accurate. Scientific justification extends     beyond the local department as publishing the data acquired will allow other hospitals to     adopt the same test meals and normal ranges, leading to standardisation of the clinical     protocol employed across the UK. Since the investigators institution are recognised as the     leading Nuclear Medicine GI centre in the UK and have previously carried out audits and in     vitro testing in the area of gastric emptying, it seems fit that they should lead the     national change in protocol.      The proposed study will involve recruitment of healthy volunteers who will eat a meal     containing 10MBq of a radioactive tracer. They will be subsequently scanned using a gamma     camera with imaging lasting no more than 3 hours in total. Approximately 40 healthy     volunteers (18-70 years old, no history of gastrointestinal problems or other serious health     issues e.g. diabetes and pregnant women are excluded) will be recruited and the studies will     be conducted on site i.e. within the Nuclear Medicine department at City hospital.   "
22256|NCT02994290|"     The purpose of the proposed pilot study is to assess the implementation of IPP-HPV     immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and     facilitators of this intervention to optimize its feasibility and effectiveness. It is     imperative that innovative interventions be developed to achieve comprehensive utilization of     this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical and     other HPV associated cancers, and address cancer disparities.   "
22257|NCT02994277|"     The purpose of this study is to use closed-loop systems with the algorithms designed by the     University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad     Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion     of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).   "
22243|NCT02994459|"     People who are obese often have insulin resistance (inability of insulin to properly control     blood sugar) and high blood sugar. However, not all people with obesity have this problem.     About one third of people with obesity have normal sugar metabolism (the way your body uses     sugar). The reasons why some people with obesity have a problem with blood sugar control and     others do not are not entirely clear. It is thought that impaired muscle sugar uptake is the     main problem related to high blood sugar in people with obesity. However, adipose tissue (fat     tissue) also consumes a substantial amount of blood sugar. Therefore, it is unclear whether     muscle or adipose tissue (fat tissue) are primarily responsible for altered blood sugar     concentrations in persons with metabolically abnormal obesity (MAO) (those with insulin     resistance and high blood sugar), compared to those with metabolically normal (healthy)     obesity (MNO), or whether healthy adipose tissue (fat tissue) expansion in MNO people     compared with lean people provides a vessel for blood sugar removal that helps maintain     normal blood sugar concentration.      Accordingly, the investigators will determine the amount of sugar that is taken up by the     body and in the cells of adipose tissue (fat tissue) and muscle by infusing labeled sugar     into the blood and looking at its disappearance from blood and appearance in adipose tissue     (fat tissue) and muscle. The investigators will also determine how well insulin, a hormone     that controls blood sugar, turns on signals that stimulate sugar uptake in fat and muscle     cells. These studies will be done after an overnight fast and during an infusion of sugar and     insulin (hyperinsulinemic-euglycemic clamp), in sex- and age-matched MNO and MAO people and a     group of sex- and age-matched healthy lean people.   "
22244|NCT02994446|"     The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter     and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)   "
22263|NCT02994199|"     The purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted     game controllers on quality of game play, enjoyment, and energy expenditure during active     video gaming in persons with mobility impairments. The controllers to be evaluated include     off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.   "
22264|NCT02994186|"     Bariatric surgery is the most effective, long-term treatment for morbid obesity, and     consistent with previous findings, individuals who lose significant weight after surgery also     have improved cognition or brain function. The mechanisms behind these cognitive     improvements are currently unknown, but are the focus of much research effort. The goal of     this pilot study is to thoroughly describe these changes in surgical versus medical weight     loss patients over time in a repeated measures fashion.   "
22265|NCT02994173|"     To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous     patient-controlled analgesia bolus dosing and effects in patients scheduled for     posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation   "
24356|NCT02966860|"     A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects     under fasted conditions   "
22245|NCT02994433|"     Most clinical major depression responds to standard treatments (medication and     psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond     to these treatments and are referred to as treatment-resistant major depression (TRMD). New     treatments for TRMD are needed, and one promising line of research are drugs known as     N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our     group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD. This     application proposes to take the next important step in understanding how nitrous oxide     exerts its effects in the human brain by using state-of-the-art brain neuroimaging     (functional connectivity magnetic resonance imaging) in a group of non-depressed, healthy     volunteers and comparing the results to a group of TRMD patients.      This study involves exposing 20 non-depressed healthy participants and 20 TRMD participants     to nitrous oxide and a placebo gas, to compare their brain images before and after each of     the inhalation sessions. Sessions will be separated by at least one month to prevent     treatment effects from carrying over into the following session. All willing and eligible     subjects will undergo up to six functional connectivity MRI scans, and two inhalation     sessions. Functional imaging in the brain will allow us to trace the interconnections between     various parts of the brain, including those involved with emotion and depression.      Other procedures will involve screening materials to ensure safety of the participants before     beginning the study (i.e. no MRI scan contraindications) and that subjects meet eligibility     criteria to being in the targeted age range, depression/non-depressed state, neurological     disorder history, and no medication exclusions.   "
22246|NCT02994420|"     The purpose of this study is to better understand how female sex hormones influence the food     intake in the gut system through the release of satiety hormones as well as through central     regulative mechanisms in the brain that subsequently contribute to the control of eating in     healthy women at different stages of the ovarian cycle.   "
22247|NCT02994407|"     The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate     the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients     with severe haemophilia A.   "
22248|NCT02994394|"     To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15     and 30 mg in healthy adult male subjects.   "
22249|NCT02994381|"     This will be an open-label, non-randomized, single oral dose study in healthy male subjects.      All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL),     containing NMT 1.3 MBq (37 μCi) 14C.   "
22250|NCT02994368|"     The purpose of this study is to understand the rate of progression of all stages of     choroideremia using a variety of assessments performed in the clinic including visual field     measures, specialized photography of the eye and participant-reported visual problems   "
22251|NCT02994355|"     Location: Family Planning Clinics in Mombasa County, Kenya      Introduction:      Integration of HIV treatment and prevention with family planning (FP) services is a promising     approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well     as prevention services for those who are negative. In Mombasa County, the USAID-supported     AIDS Population and Health Integrated Assistance II Program revised the FP Clinic Register to     capture HIV testing in 2008. However, the rate of HIV testing in FP clinics remains low. Our     overarching objective is to assess the effectiveness, costs, and budget impact of     implementing the systems analysis and improvement approach (SAIA) to increase HIV testing in     FP clinics in Mombasa County.      Methods:      The investigators aim to conduct a cluster-randomized trial comparing the effect of the SAIA     approach versus usual procedures on rates of HIV testing in first-time attendees at 20     intervention versus 20 control FP clinics in Mombasa County. The investigators will compare     HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control     facilities after an additional year, during which FP clinics in the intervention arm will be     encouraged to continue to use the SAIA tools with minimal support from the study team as the     Mombasa County Ministry of Health will take ownership of implementation. Lastly, the     investigators aim to estimate the incremental cost and budget impact of applying SAIA versus     standard of care using an activity-based approach.      Anticipated Results:      The investigators anticipate that SAIA will produce significant and sustained improvement in     HIV-testing rates in first-time FP clinic attendees in intervention clinics compared to     control facilities. The use of a rigorous study design will provide strong evidence to guide     integration of HIV testing into FP services in a wide range of settings. The inclusion of     costing and budget impact analyses will assist policy makers in reaching informed decisions     about implementation.      Anticipated Conclusion:      By addressing the crucial first step in the linkage of HIV and FP services, this research     holds considerable promise for improving women's health by opening the gateway to HIV care     and prevention.   "
22252|NCT02994342|"     Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal     dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated     post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up     only for women applying ZP-025 vaginal gel.   "
22258|NCT02994264|"     The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent     chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of     the extremities at the investigators institution paired with patients treated by adjuvant     radiation therapy   "
22261|NCT02994225|"     The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes     is of paramount importance in the subsequent management of this cancer and surgery of     invasive breast cancer involves axillary lymph node dissection (ALND). To preserve arm     lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic     drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is     uncertain.      The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of     draining lymphatics. The project aims to train surgeons to the technique and to identify     predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary     pathological parameters to better select patients who would not require removal of the ARM     node in the future   "
22262|NCT02994212|"     Community-based management of severe acute malnutrition (SAM) has been shown to be safe and     cost-effective, but program coverage remains low. New treatment models that maintain high     levels of clinical effectiveness but allow for increased coverage are still needed. A reduced     schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on     a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to     describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic     food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and     household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot     intervention study in which 115 children eligible for the outpatient treatment of SAM were     provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis     for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm     circumference) MUAC gain, weight loss > 5%, and the development of edema. Unannounced     household spot checks were conducted over 4 weeks to assess household utilization of RUTF and     storage practices.   "
22266|NCT02994160|"     Our goal is to temporarily implant the following groups for 90 days:        1. Three human partial hand amputees (amputated at the level of the hand) with 2 FAST-LIFE          electrodes, one inserted into the motor fascicle of the ulnar nerve and the other into          the sensory fascicle.        2. Five human hand and forearm amputees (amputated at the level of the forearm) with 2          FAST-LIFE electrodes in the ulnar nerve (one in the motor fascicle, one in the sensory          fascicle) and 4-5 FAST-LIFE electrodes in the median nerve (one in the motor fascicle,          one in each of the 3-4 sensory fascicles).   "
22267|NCT02994147|"     Repeated joint bleeding leads to hemophilic arthropathy (HA), which manifests with chronic     synovitis, cartilage damage and bony destruction. Currently available treatments of HA,     including analgesics, NSAIDs, and hyaluronic acid, are predominantly directed toward the     symptomatic relief of pain and inflammation, with no or little effect on joint cartilage     degeneration. AC201CR, a control released formulation of AC-201, demonstrates     anti-inflammatory effects by reducing NLRP3 inflammasome assembly. AC-201 is also unique in     that it influences both the anabolism and catabolism of chondrocytes in vitro and has shown     cartilage-sparing properties in animal studies. The study is designed to evaluate the joint     structure-modifying and symptom-relieving effects, safety, and tolerability of AC-201CR in     subjects with HA.   "
22268|NCT02994134|"     The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or     high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and     postural control in sedentary healthy adults.   "
22269|NCT02994121|"     In this longitudinal prospective natural history study of multiple sclerosis (MS), the     overarching goal is to understand the factors that influence individual variation in disease     trajectory and treatment response and pave the way for realizing precision medicine in MS.     Because MS is a chronic neurological disorder, this observational cohort study will span a     30-year time frame.   "
22270|NCT02994108|"     Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer     (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g.,     receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk     for HPV infection and are disproportionately affected by HPV-related cancers. A safe and     effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the     U.S. have been low, particularly among males. To remedy this gap, the goal of this study is     to develop and pilot test a text messaging intervention to increase HPV vaccination in young     MSM.      The study has two specific aims:        1. Develop, iteratively refine, and pre-test messages using a formative research procedure          for designing targeted health interventions. The procedure consists of the following          steps: 1) conduct online focus groups, an online survey, and in-depth interviews to          inform message content, 2) draft initial messages based on focus group findings and          pilot data, 3) refine message content and assess acceptability using content advisory          teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta          test the protocol.        2. Test the feasibility, acceptability, and preliminary efficacy of the Txt2Protect (T2P)          text messaging intervention in a pilot randomized controlled trial (RCT). To achieve          this aim, 460 unvaccinated MSM (ages 18-26) who live in the Chicago metro area will be          randomly assigned to the treatment (T2P) or control condition. The treatment condition          will receive a culturally appropriate text messaging-based HPV vaccination intervention          based on the Information, Motivation, and Behavioral Skills model, whereas the control          condition will receive a text messaging-based sexual health intervention that includes          basic facts about HPV vaccination readily accessible online.      Primary outcome measures include intervention feasibility (e.g., retention in the trial),     acceptability (satisfaction with the intervention), and preliminary efficacy as determined by     initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the     end of the 9-month trial.      The study team hypothesizes that participants in the T2P condition (vs. control) will report     greater acceptability of the intervention and will be significantly more likely to initiate     and complete the 3-dose HPV vaccine series by the end of the trial.   "
22271|NCT02994095|"     This was a pilot study to assess the feasibility and acceptability of training Community     Health Agents in Motivational Interviewing in real-life primary care centers.   "
22272|NCT02994082|"     This is a pilot study designed in an effort to develop and improve access to effective     treatments for tobacco use in rural Veterans using a tailored intervention approach.     Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco     cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco     users including elevated depressive symptoms, risky alcohol use, and concerns about weight     gain. The objectives are to:        1. Evaluate the feasibility of an individually-tailored telephone intervention for rural          smokeless tobacco users        2. Examine the impact of the intervention on treatment utilization, patient satisfaction,          and smokeless tobacco cessation.   "
22273|NCT02994069|"     Patients will receive standard of care radiation therapy to the primary tumor of the head and     neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or     every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity     and the level of reactive oxygen species generated by the drug in subjects with squamous cell     carcinoma of the head and neck treated on this trial.   "
22274|NCT02994056|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with     ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection     and Child-Pugh-Turcotte (CPT) class C cirrhosis.   "
22275|NCT02994043|"     The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse     Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders     (AUD) by implementing an 8-week long intervention and examining neurobiological,     immunological, and epigenetic characteristics of AUD.   "
22276|NCT02994030|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Duchenne     disease from plasma   "
22277|NCT02994017|"     The objective of study is to prospectively determine if CPET with blood gas analysis should     have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients.     Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test     or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients     will perform a maximal exercise test on a cycloergometer during the inclusion visit, with     pulmonary function testing and a six-minute walk test. The study will also include a visit     every 6 months with: body mass index calculation, pulmonary function testing with DLCO     (diffusing lung capacity for carbon monoxide), a six minute walk test, and     antibacteriological study of sputum. The results of this study could help identify earlier     the patients for referral to a lung transplantation centre, by using the usual criteria and     the CPET abnormalities.   "
23331|NCT02980237|"     The objective this study is evaluate if an e-Health education program at the workplace to     contributes to improve quality of life from Office Workers. And:Life style modification;     Improve physical activity Reduces on Anthropometric Measures; Reduces Pain and discomfort in     the musculoskeletal system   "
22278|NCT02994004|"     Hospital physicians are increasingly facing budgetary constraints that might have an impact     on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might     translate into role conflict and ambiguity. We explore the medical decision-makingprocess of     physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated     medical decisions during fMRI acquisitions, with and without explicit budgetary constraints.     We will compare the fMRI data between the 2 modalities.   "
22279|NCT02993991|"     This is a Phase 1 Window of Opportunity study to evaluate the pharmacodynamic and immune     effects of pre-operative therapy with Mocetinostat and Durvalumab on patients with squamous     cell carcinoma of the oral cavity.   "
22280|NCT02993978|"     The purpose of the study is to evaluate the effect of changes in the care environment in     pediatric radiotherapy. The definitions of the changes is a part of the study, and is     constructed in collaboration with the institute of design at Umeå University. The     implementation is however not part of the study, but done as part of Clinical routine.      The study consist of two parts, where the first 1.5 years are a Control phase where the     changes are designed and also function as a baseline period. The following 1.5 years are the     case period where the Changes that are accepted for Clinical implementation are implemented.      The impact of the changes are evaluated using surveys and interviews of both parents and     children   "
22281|NCT02993965|"     The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and     sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct     centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates     among adolescents ages 11-17.   "
22282|NCT02993952|"     One of the major challenges faced by researchers working in the field of rehabilitation     science is the ability to provide integrative approaches to the use of clinical practice. In     this context it becomes increasingly necessary to construct investigative approaches, so that     they can reach clinical practice in a shorter period of time,since the large volume of     information produced globally does not impact in the short or medium term on new therapeutic     recommendations. Among the various chronic painful entities, there is chikungunya fever as a     highlight for having a rich clinical chronology in relation to pain. Its therapy is used done     by drugs in almost all national and international consensuses, therefore therapy against pain     in chikungunya fever is limited during the rehabilitation process. It is very important that     the science of rehabilitation enhances methods of noninvasive brain modulation that enable,     through the excitation or inhibition of specific cortical areas to produce pain inhibiting     effects, providing a simple and low cost treatment to the clinical routine.Technological     advances and non-invasive techniques to modulate brain function have been developed, for     instance, Transcranial Direct Current Stimulation (tDCS).      The objective of the present project is to present the tDCS as a new modality of physical     rehabilitation for the patient with chronic pain resulting from chikungunya fever. The     purpose of the study is to present physical, behavioral and social results of the application     of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional     status of the individual.   "
22283|NCT02993939|"     Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle     brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may     not be tolerated in patients with chronic pulmonary disease.      This RCT will compare the classic Interscalene block with combined infraclavicular block plus     suprascapular nerve block in patients going for arthroscopic shoulder surgery.      Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are     pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.   "
22286|NCT02993900|"     This research is being done to evaluate multimodality imaging, including magnetic resonance     imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy     takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose     of this study is to investigate the ability of MRI to successfully guide the placement of the     brachytherapy applicator necessary to treat participants' gynecologic cancer. The     Investigators want to see if the use of MRI will do a better job of assessing the tumor at     the time of brachytherapy than the routinely used CT scan. The Investigators also want to     determine if the use of MRI will enable doctors to reduce the radiation dose received by the     body during the process of treating the tumor.   "
22287|NCT02993887|"     The investigators will conduct a randomized clinical trial pilot study to examine the     effectiveness of a theoretically based intervention (called ReMind) encompassing two key     components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness     meditation delivered using a smart phone application (Stop, Breathe & Think™) with an     intervention (Mind Only) that consists only of daily mindfulness meditation. Both components     of the intervention have been tested separately (but not combined) and both interventions can     be self-tailored, which meets the vital need for these caregivers to engage in     self-management activities when it is convenient for them. The investigators will test the     two arms of the intervention in 30 parents of technology-dependent children, 15 parents in     each group. The investigators will collect mixed data at baseline, 3 months and 6 months     after subject enrollment to describe changes in proximal and distal outcomes. The     investigators aim to:        1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and          Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive          factors, resourcefulness) and determine if there are different effects between ReMind          and Mind Only interventions.        2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life,          Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical          (Physical Health Related Quality of Life), and cost outcomes between subjects in the          ReMind and Mind Only arms over time.        3. Determine the moderating effects of parents' social support, demographics (age, gender,          family income) and children's functional status on (a) proximal outcomes and the          relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis          Function, stress, cognitive factors and distal outcomes.        4. Evaluate the impact of decentering on the association between the interventions and the          proximal and distal outcomes.        5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal          and distal outcomes associated with each intervention.   "
22288|NCT02993874|"     The aim of this study will be to verify the effect of creatine supplementation associated to     clinical treatment of the functional capacity in patients with intermittent claudication.   "
22309|NCT02993601|"     The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering     from heart failure, who have peripheral oedema. The device is non-contact and does not     requires patient compliance to work. It gives an output reading of the patient's lower leg     volume.      During the study, this measurement will be compared to clinical standard and gold standard     measurements as well as clinical grading of peripheral oedema.   "
22310|NCT02993588|"     The purpose of this study is to investigate the impact of melatonin administration on in     vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes     and embryos in the prospective poor responders.   "
22289|NCT02993861|"     The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to     characterize the pharmacokinetics and safety of four oral anti-epileptics drugs     (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if     inadequate enrollment}, topiramate, and ocarbazepine) in a non-randomized sample of obese     children and adolescents. The study's duration will be up to eleven days (up to seven days of     screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18     years will be identified through outpatient clinic schedules and inpatient admissions at each     clinic site. Participants receiving at least one of the study drugs per local standard of     care will have pharmacokinetic concentrations in plasma drawn according to the specific     dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip     ratio, medical history, concomitant medication history, documentation of study drug oral     intake, adverse effects, and physical examination. The sample size will include 24     participants for each anti-epileptic drug (total 96).   "
22290|NCT02993848|"     The North American Scapula Consortium (NASCon) is a multi-center injury specific outcomes     registry.      There currently exists a paucity of outcomes data in the literature on this patient     population. The NASCon registry will be a resource in which investigators can conduct     adequately powered clinical outcomes research resulting in higher quality research with     meaningful results, improved patient care, and evidence-based advancement for the treatment     of scapula fractures. Registries can lead to significant discoveries in comparative     effectiveness specifically in areas where randomized control studies are not possible.     Collecting post-treatment (operative and non-operative) patient outcome data for similar     injury patterns has been shown effective in uncovering optimal standards for treatment.   "
22291|NCT02993835|"     Determination of fractional iron absorption from bouillon fortified with 3 labeled iron     compounds.   "
22292|NCT02993822|"     The purpose of this study is to determine the effectiveness of three doses of orvepitant,     taken once a day, in the treatment of chronic refractory cough.   "
22293|NCT02993809|"     The intent of this clinical study is to evaluate the safety of the injection composed of     autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract     (PRPE) for the treatment of critical limb ischemia.   "
22294|NCT02993796|"     The purpose of this study is to develop a clinical database of individuals diagnosed with     Krabbe disease in order to determine which symptoms herald the onset of clinical disease in     the various phenotypes of Krabbe disease; to determine whether level of GALC enzyme activity,     or a specific genetic mutation predict the clinical course; and to determine which     neurodiagnostic tests predict onset and/or severity of the disease.   "
22295|NCT02993783|"     The purpose of this study is to assess the initial activity, tolerability, safety and to     identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for     treatment of steroid-refractory acute intestinal GvHD in participants who have undergone     allo-HSCT.   "
22296|NCT02993770|"     All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic in     Farabi hospital will be systemically evaluated. Those with confirmed diagnosis of primary     nasolacrimal duct obstruction (PANDO) that need DCR by one senior ophthalmic plastic     consultant, will be randomly assigned to one of the 2 treatment groups: Group 1 External DCR     and group 2 En-DCR. Diagnosis of PANDO will be based on the presence of positive     regurgitation test or irrigation test or dacryocystography (DCG) . All patients will undergo     comprehensive ophthalmology examinations including best corrected visual acuity (BCVA),     relative afferent pupillary defect (RAPD), slit lamp anterior segment evaluation, dilated     fundoscopy with 78 D lens. Past history and review os systems will be elicited for     medications, past or intercurrent dacryocystitis,trauma,past ocular and sinus surgeries,     epiphora, discharge, ocular diseases, sinus/nasal diseases, diabetes mellitus, organ     transplant, immunosuppressive drugs and immunodeficiency disorders.      All operations will be performed under general or local anesthesia, based on patient and     surgeon preferences.      Surgical Technique:      All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in     endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by     Wormold.      Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal     sac will be incised and elevated. Then rhinostomy will be made using forceps, exposing     lacrimal sac. Lacrimal sac will be opened and a Crawford silicone tube will be passed through     puncta into nasal cavity and stabilized and will be kept for 2 months. After operation     patients will receive nasal beclomethasone twice daily for 2 weeks, nasal drop phenylephrine     0.25% four times daily and ophthalmic drop fluorometholone and Levofloxacin four times daily     for one week.      External DCR will be performed in a conventional manner [2]via a nasal side straight skin     incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be     separated using blunt dissection to expose the periosteum overlying and medial to the     anterior lacrimal crest. After incision of the periosteum, an osteotomy approximately 10 mm     in diameter will be prepared. The lacrimal sac and then nasal mucosa will be opened by an H     incision to form maximal anterior flaps. A Bodkin tube will be passed through puncta into     nasal cavity of stabilized by multiple square knots at the end. The small posterior flaps     will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0 vicryl     sutures. The periosteum, orbicularis oculi muscle, will be sutured by 6-0 vicryl sutures.     Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner. Nasal packing     will not be placed. All Ext-DCR operations will be performed by one of the two expert     ophthalmic plastic surgeons (F.P and A.K.).      The amount of bleeding will be estimated and recorded by the subtracting the total suction     reservoir from the amount of irrigated fluid through syringe during operation. Time of     operation will be estimated and recorded from the time of anesthetics injection to removing     the drape.      One week after operation patients will be asked to report post-operative pain and discomfort     by visual analogue score scale (0-10).      27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is     healed, and complications, if any, will be detected and recorded in the special data sheets.     Nasal bleeding, medial canthal swelling and erythema, ocular surface fluorescein staining and     any complications will be detected and recorded. Dye disappearance test (DDT) will be checked     and recorded. Epiphora will be recorded according to modified Munk epiphora staging scale.      Two months after operation, ocular surface will be checked by fluorescein for staining of     cornea and conjunctiva. Then silicone tube will be removed. epiphora will be recorded     according to our staging system. Dye disappearance test (DDT) and Fluorescein Dynamic Dye     test (FDDT) and irrigation test, epiphora and skin scar by visual analogue scale (VAS) visual     analogue scale will be checked in months 2, 6, 12, 18 and after operation. Satisfaction will     be checked 2 mo and 18 mo after operation by VAS. Any grade of daily epiphora or return of     fluid>20% through opposite punctum in irrigation test or negative FDDT (absence of fluid     passage) will be regarded as functional or anatomic failure, respectively. Any complication     will be recorded in the specific forms.      All pre-operative and post-op examinations will be performed by a masked senior ophthalmology     resident subjective data will be checked and recorded by a trained nurse   "
22297|NCT02993757|"     The aim of the study is to assess the safety and immunogenicity of the CYD dengue vaccine     when administered concomitantly or sequentially with Gardasil® (Human Papillomavirus     Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant).      Primary objectives:        -  To demonstrate that the humoral immune response (in terms of geometric mean          titers[GMTs]) to Gardasil after concomitant administration is non-inferior to sequential          administration with the CYD dengue vaccine measured 28 days after the last dose of          Gardasil.        -  To demonstrate that the humoral immune response to the CYD dengue vaccine after          concomitant administration is non-inferior to sequential administration with Gardasil          measured 28 days after the last dose of the CYD dengue vaccine.      Secondary Objectives:        -  To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil          after concomitant administration is non-inferior to sequential administration with the          CYD dengue vaccine measured 28 days after the last dose of Gardasil        -  To describe the humoral immune response to Gardasil at baseline and after each dose of          Gardasil in each and any group        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after          each dose of the CYD dengue vaccine in each and any group        -  To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in          each group.   "
22302|NCT02993692|"     The aim of study was to compare the hemodynamic responses and adverse events associated with     nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope     (DLS) in children undergoing general anesthesia for outpatient dental surgery. Eighty     children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under general     anesthesia and who required nasotracheal intubation were included.   "
22303|NCT02993679|"     The objective of this randomised cohort study was to evaluate the knee rotational stability     after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and     to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when     the ALL is necessary to reconstruct.   "
22304|NCT02993666|"     This study is conducted to evaluate the effectiveness of forced air warming using upper and     lower body blankets by measuring core body temperature in patients undergoing video-assisted     thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.   "
22305|NCT02993653|"     Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with     intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial   "
22306|NCT02993640|"     The purpose of this study is to determine if vasopressin and nitroglycerin in combination     will affect hepatic hemodynamics, in the setting of liver surgery.   "
22307|NCT02993627|"     In this double-blind Randomized Controlled Clinical Trial investigators are going to study     the effects of Spirulina supplementation on anthropometric measurements, lipid profile,     appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese     adults.   "
22308|NCT02993614|"     This is a comparative effectiveness study comparing new users of SGLT-2 inhibitors with new     users of other glucose lowering drugs with regard to hospitalization for heart failure and     all cause mortality respectively. The study is carried out based on data from six countries:     Unites States, United Kingdom, Germany, Sweden, Denmark and Norway   "
22311|NCT02993575|"     The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared     to non-ICU patients. The investigators will determine total and free flucloxacillin     concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion     (n=20) of flucloxacillin as standard care.      Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing     regimen and limited sampling will be taken for individual patients on the continuous dosing     regimen on day 2 and 4.   "
22312|NCT02993562|"     This project has the following primary aims:      To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during     the first six months after starting levothyroxine (L-T4) substitution therapy      Secondary aims are:      To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body     mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut     and pancreatic hormone responses, gastric and gall bladder emptying, resting energy     expenditure (REE), quality of life (QOL) and cognitive function   "
22313|NCT02993549|"     Head injury is a common and devastating condition that can affect people at any stage of     their lives. The treatment of severe head injury takes place in intensive care where     interventions are designed to protect the brain from further injury and provide the best     environment for recovery. A number of different monitors are used after head injury,     including a monitor called microdialysis, to measure how the brain is generating energy.     Abnormalities in these monitors guide doctors to the right treatments when the brain is at     risk of further injury. There are lots of ways that the brain can be injured further after     head injury such as raised pressure in the skull from brain swelling, low oxygen levels and     low glucose levels. In this study we aim to combine information from all of these monitors to     figure out what the underlying problem is and choose the right intervention to treat the     problem that is affecting the patient at the time and compare this with previous treatment     protocols to see if it improved outcome.      Aim:      To establish and validate a protocol to treat abnormalities in a microdialysis measure called     lactate/pyruvate ratio (LPR) that reflects how cells are generating energy, and compare it     with patient cohorts not being monitored using the current protocol.   "
22314|NCT02993536|"     The purpose of the study is to assess the evolution of B cells at a genetic and     surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted     population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will     include patients with relapsed or refractory disease who require therapy with idelalisib and     rituximab as per FDA label. This is an observational study for peripheral blood samples of     these patients collected at pre-determined time points.   "
22326|NCT02993380|"     Patients with chronic kidney disease (CKD) have higher mortality rate than general     population. Especially, the most common cause of mortality was known as cardiovascular     disease that account for almost 50 percent in patients with dialysis. Mediterranean diet was     reported for lowering risk of coronary artery disease in general population. Mediterranean     diet is not acceptable in CKD patients because of restriction of potassium, phosphorus, and     protein.      Relatively proper food among Mediterranean diet for hemodialysis patients is olive oil. Many     researchers usually preferred olive oil as control group for evaluating effect of omega-3     fatty acid. However, previous studies reported that control groups using olive oil of 3g in a     day have shown increased components of omega-3 fatty acid such as eicosapentaenoic acid (EPA)     or docosahexaenoic acid (DHA). Therefore, cardioprotective effect of olive oil may be     associated with increasing of omega-3 fatty acid levels.   "
23379|NCT02979613|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate     (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.   "
22315|NCT02993523|"     Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white     blood cell responsible for fighting infections). Successful treatment of AML is dependent on     what subtype of AML the patient has, and the age of the patient when diagnosed.      Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a     cell) that allows cancer cells to stay alive. This study is designed to see if adding     venetoclax to azacitidine works better than azacitidine on its own.      This is a Phase 3, randomized, double-blind (treatment is unknown to patients and doctors),     placebo controlled study in patients with AML who are >= 18 or more years old and have not     been treated before. Patients who take part in this study should not be suitable for standard     induction therapy (usual starting treatment). AbbVie is funding this study which will take     place at approximately 150 hospitals globally and enrol approximately 400 patients.      In this study, 2/3 of patients will receive venetoclax every day with azacitidine and the     remaining 1/3 will receive placebo (dummy) tablets with azacitidine.      Patients will continue to have study visits and receive treatment for as long as they are     having a clinical benefit. The effect of the treatment on AML will be checked by taking     blood, bone marrow, scans, measuring side effects and by completing health questionnaires.     Blood and bone marrow tests will be completed to see why some people respond better than     others. Additional blood tests will be completed for genetic factors and to see how long the     drug remains in the body.   "
22316|NCT02993510|"     The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide®     collagen membrane either sutured or glued compared to microfracture alone in the treatment of     symptomatic cartilage defects of the knee.   "
22317|NCT02993497|"     In patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a     respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red     camera by measuring the respiratory rate, ventilation volume, and ventilation volume with     respiratory volume monitor.   "
22318|NCT02993484|"     The overall aim of this study is to examine the role of mitochondrial respiration in human     diabetic tissue before and after ischemia. Furthermore we will examine the ability of     ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic     performance of both non-diabetic and diabetic fibers after ischemia. To increase our     understanding on the metabolic changes during ischemia in both non-diabetic and diabetic     tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic     mitochondrial respiration.   "
22319|NCT02993471|"     This study is known as a drug interaction study. The purpose is to learn about how     ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine,     omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome     P450. Each participant will complete two study periods. Participants will take the mixture of     commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with     ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about     17 weeks, including follow-up. Screening must be completed prior to study start.   "
22320|NCT02993458|"     The Camp DASH study trial will compare the effect of two dietary patterns and two levels of     sodium intake on blood pressure and blood lipids in adolescents in the upper third of     distribution for blood pressure. The two dietary patterns are based on the Dietary Approaches     to Stop Hypertension (DASH) trial in adults.   "
22321|NCT02993445|"     The purpose of this study is to evaluate the effect of complementary and alternative     therapies, specifically alternate nostril breathing and foot reflexology, on intraocular     pressure in patients with ocular hypertension.   "
22322|NCT02993432|"     It is currently unknown if there is a way to decrease the risk of cesarean delivery when     undergoing cervical ripening and induction of labour. Some research suggests a Foley catheter     placed through the cervix and filled to 80cc may decrease this risk. We wish to run a large     scale trial to see if Foleys filled to 80cc decrease the risk of Cesarean section compared to     the commonly used medication for cervical ripening, prostaglandins. Before we can undertake a     large trial, we need to do a pilot to see if women will agree to participate in this type of     study. As well, a pilot will help with trouble shooting prior to a large trail, to improve     the chances of successfully answering this clinically important question.   "
22323|NCT02993419|"     This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study,     into the group of children in the hospital that use clinical antibiotics from one month to     three years old，by observing the given antibiotics at the same time with the whole bowel raw     or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole     bowel prevention clinical efficacy and safety of AAD.   "
22324|NCT02993406|"     The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus     placebo decreases the risk of cardiovascular events in patients who are statin intolerant.   "
22325|NCT02993393|"     Abstract Background and Goal of study Teaching and learning in airway management are     essential in anesthetic field. Though simulation-based and problem-based learning are     sophisticated learning tool, neither of them manifests the superior benefit. We would like to     compare the teachers' and students' attitudes on these two learning methods.      Material and Methods After IRB approval No. 369/2558(EC3). A prospective,     questionnaires-based study was performed amongst volunteered, consent-signed, 10     anesthesiologists and 40 nurse anesthetist students. After stratified randomization, ten     students simultaneously attended either SBL or PBL course one at a time. Six weeks later, a     crossover technique was applied for both groups. At the end of project, teachers and students     had to response to Likert's scale questionnaires.      The teachers' questionnaire based on table of specification of the learning contents,     consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow     up care. The students' questionnaire comprised 3 parts: learning content, process and     evaluation.      The validation of the questionnaire was determined by three board-certified     anesthesiologists. The index of item objective congruence was 0.80 and 0.82 with Cronbach's     Alpha of 0.97 and 0.92 respectively.   "
22327|NCT02993367|"     Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to     progress to dementia, but there have been no proper large-scale intervention trials dedicated     to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical     VCIND) represents a relatively homogeneous disease process and is a suitable target for     therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft     Capsules is effective for cognitive impairment of vascular origin. In this randomized,     double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of     Butylphthalide Soft Capsules in patients with VCIND.   "
22328|NCT02993354|"     The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable     as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is     safe and effective in monitoring uterine contractions. The investigators propose to perform a     series of studies to validate the accuracy and clinical usefulness of the EUM device by     simultaneously monitoring patients with current methods (with either external or internal     devices) as clinically indicated and with the EUM device. Providers will be blinded to the     results of the EUM device. The investigators will continue care as per current guidelines     using the information obtained from the current monitoring methods. Information obtained from     the EUM devices will not be used to determine the clinical course of action.   "
22329|NCT02993341|"     Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical     benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication     with low complication risk. Its use in the hip fracture population is unproven. The purpose     of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction     of peri-operative blood loss in hip fracture surgery.   "
22330|NCT02993328|"     This trial will be a double-blind, single-center, randomized, placebo controlled study to     evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up     to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of     mild-to-moderate plaque psoriasis.   "
22331|NCT02993315|"     The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after     complete radical lymph node dissection in stage IIIB and IIIC melanoma patients, improves     recurrence-free survival (RFS) as compared to treatment with matching placebo.   "
22332|NCT02993302|"     Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating     autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in     healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro     1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral     1α-D3 on DC maturation in GD patients.   "
22333|NCT02993289|"     Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to     European guidelines and based on evidence, multidisciplinary detoxification is the first     choice of treatment for MOH. However, consensus about the details in such detoxification     programs is lacking. Contrary, other headache specialists believe more in treating chronic     headache with medication overuse with single-therapy of prophylaxis and no withdrawal of     acute medication, based on randomized controlled double-blinded placebo trial with     prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to     detoxification. However there was no significant difference.      AIM:        1. To compare three different treatment protocols in order to improve the therapy of MOH.        2. To test several baseline variables for being potential predictors for good treatment          outcome.        3. To examine the role of epigenetics in MOH.   "
22334|NCT02993276|"     PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT     Neuro)      This post-market surveillance study is conducted to provide post market surveillance     information regarding long-term performance and ease of use of the Polyganics nerve capping     device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.   "
22335|NCT02993263|"     The investigators propose to estimate the sensitivity and specificity of the VectraplexECG     System for detecting acute myocardial ischemic injury, including acute myocardial infarctions     after major non-cardiac surgery.      A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the     post-anesthesia care unit.      On the first, second and third post operative morning a 10 second CEB dynamic sequence will     be recorded. Blood will be sampled for troponin as well.      On the first, second and third post operative afternoons a 10 second CEB dynamic sequence     will be recorded.      The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long     as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will     continue as long as the patient remains hospitalized.   "
22336|NCT02993250|"     The main purpose of this study is to evaluate the safety and tolerability of a combination     treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese     participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis     and for 12 weeks in direct-acting antiviral (DAA)‑naive Japanese participants with genotype 1     or 2 chronic HCV infection with compensated cirrhosis.   "
22337|NCT02993237|"     The primary purpose of this study is to assess the acceptability of swallowing the     darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide     (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human     immunodeficiency virus (HIV) -1 infected adolescent patients.   "
22338|NCT02993224|"     Study to evaluate patient preference of deferasirox FCT or deferasirox DT in patient with     transfusion - dependent thalassemia or non-transfusion -dependent thalassemia as measured by     preference questionnaire at Week 48   "
22339|NCT02993211|"     Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a     piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate     surgical technique in bladder tumour resection. By preventing tumour fragmentation and     ascertaining complete tumour resection by histological assessment of the EBR specimen, we     hypothesized that EBR could reduce disease recurrence as compared to SR.   "
22531|NCT02990884|"     Ilioinguinal / iliohyogogastric nerve blocks; It is frequently used for analgesia and     anesthesia in inguinal region surgeons. However, 95% of these surgeons are under general     anesthesia. aim of this study; Intra-operative anesthesia and analgesia effects of     ilioinguinal / iliohyogogastric nerve block supported by ketamine sedation only.   "
22340|NCT02993198|"     The Cardio-Oncology program at Northwestern offers care to cancer patients who develop     cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2     necessitate treatment with anthracycline and/or trastuzumab and pertuzumab-based     chemotherapies, which are known to cause cardiac toxicities. Breast cancer patients will     undergo a cardio-oncology echocardiogram which incorporates advanced left ventricular     assessment by utilizing deformation or strain imaging during chemotherapy treatment for     surveillance of cardiac toxicities. The aims of this project are:        1. To create a registry of both clinical, and echocardiographic variables, biomarkers, and          genetic analysis that will be used to develop a risk model to predict LV dysfunction in          early stage breast cancer patients undergoing chemotherapy with anthracycline and/or          trastuzumab and pertuzumab-based chemotherapy regimens.        2. To propose a new management algorithm for initiation of prophylactic beta-blocker          therapy for early stage breast cancer patients with preclinical cardiac toxicities          demonstrated by strain parameters.        3. To determine if initiation of prophylactic beta-blocker therapy in patients with early          cardiac toxicity can delay or prevent a drop in LV EF and the development of clinical          heart failure.        4. To explore serial measurements of a suite of novel biomarkers during ongoing anticancer          treatment that are presumed but not yet proven to be predictive of cardiac dysfunction          in women with breast cancer.        5. To identify DNA biomarkers of predilection to cardiotoxicity.        6. To generate hiPSC to validate markers predictive of cardiotoxicity.   "
22341|NCT02993185|"     The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual     health education program, Your Move (YM) against a nutrition control program, Eat Smart     (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual     decisions with the ultimate goal of reducing unplanned pregnancies and STIs.   "
22342|NCT02993172|"     The Copenhagen City Heart Study is an ongoing cardiovascular population study initiated in     1976 which has examined approximately 25,000 individuals from the general population. The     initial sample has been re-invited up to four times and supplemented by younger individuals.     The study includes questionnaires, clinical assessment and biomarkers. The population have     been followed in a number of outcome registries and more than 900 scientific papers have been     published.   "
22343|NCT02993159|"     This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating     patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of     breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast     cancer by blocking the use of estrogen by the tumor cells.   "
22344|NCT02993146|"     This phase I trial studies the side effects and best dose of ropidoxuridine when given     together with whole brain radiation therapy in treating patients with cancer that has spread     to the brain. Ropidoxuridine may help whole brain radiation therapy work better by making     cancer cells more sensitive to the radiation therapy.   "
22345|NCT02993133|"     The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is     an autoimmune dermatological disease characterized by the production of anti-desmoclesin     antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an     autoimmune dermatological disease, characterized by the production of anti-zone antibodies of     the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid     (MPA) is an increasingly used form of corticosteroid. Despite its increasing use,     pharmacokinetics in autoimmune bullous dermatosis remain little studied.   "
22346|NCT02993120|"     This is a multicenter observational cohort study with both retrospective and prospective data     collection components in subjects with ASCVD.      The purpose of this study is to better understand cholesterol treatment patterns in the     context of a changing landscape in subjects with ASCVD.   "
22347|NCT02993107|"     The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101     through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children     and adults who have completed the ARC003 study.   "
22348|NCT02993094|"     This is an open-label phase I/II study for patients with advanced (locally advanced     inoperable or metastatic) triple-negative breast cancer progressing after first-line therapy     receiving ixazomib on days 1, 8, and 15 in combination with carboplatin on days 1, 8, and 15.     Cycles will be repeated every four weeks.   "
22349|NCT02993081|"     Study of refractive changes after capsulotomy with YAG laser in facectomized patients.   "
22350|NCT02993068|"     The goal of this research study is to test the effects of online genetic education alone or     in combination with telephone genetic counseling in order to compare the two methods and the     stress a person feels about their risk of cancer.      Researchers also want to learn how these strategies may improve participant's understanding     of genetics, participant's ability to complete a quiz about genetics, and participant's     quality of life.      URL: https://magenta.mdanderson.org   "
22351|NCT02993055|"     A Phase I dose escalation study involving healthy subjects.   "
22352|NCT02993042|"     Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by     repeating a normal gait pattern with high intensity. This study is a feasibility study to     investigate whether robot-assisted gait training can be applied to improve walking autonomy     in patients with Parkinson 's disease.   "
22353|NCT02993029|"     Osteoarthritis (OA) of knee is the most common form of arthritis in the world1e, and it has     received growing attention in the society because of the increase of old age population,     disabled people, and medical expenses from this disease. 99Tc-MDP is effective for rheumatoid     arthritis. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment     in patients with osteoarthritis of knee as compared with celecoxib.   "
22442|NCT02991872|"     The purpose of this study is to evaluate the long-term persistence of immune responses     approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in     2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the     subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged     ≥6 and ≤17 years at the time of enrollment.      This study is aimed to respond to a post-marketing commitment by the China Food and Drug     Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo     cell rabies vaccine license in China, granted in August 2015.   "
22354|NCT02993016|"     Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving     function. However, in instances where incorrect positioning and malignment of the TKA     components are observed, patients can experience a range of negative postoperative outcomes     such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant     loosening, and eventual early revision. To avoid these complications, achieving a     postoperative alignment within the range of 0°±3° of the mechanical axis is recommended.     Manual intramedullary/extramedullary guides are not thought to be capable of consistently     achieving axes in this range, and though computer-assisted navigation has shown superior     results in comparison with conventional instrumentation, it is also limited by increased     surgical times and no clear superiority in improving short-term clinical outcomes. Thus,     there has been in a push in the orthopaedic community to create more precise technologies to     aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation     (PSI), which uses anatomical data obtained primarily from pre-operative axial computed     tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs     individualized to the patient's unique anatomy, was created with this goal.      This study aims to compare the clinical results of conventional and patient-specific     instruments in total knee arthroplasty.   "
22355|NCT02993003|"     Core temperature is of greatest interest in terms of temperature monitoring as it is thought     to represent the temperature of the vessel-rich groups that are instrumental in     thermoregulatory control. The nasopharynx is among the recommended temperature monitoring     sites for core body temperature. It is the part of the pharynx that lies above the soft     palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it     communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures     are accurate in adults when probes are inserted between 10 and 20 cm.      The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants     and children. While some data suggest that anthropometric measurements are well correlated     with endoscopic measurements in infants based on weight, the accuracy of temperature     measurements at these and other distances has yet to be quantified. The investigators thus     propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature     proves that best approximate core temperature as measured in the distal esophagus in infants     and children of various sizes. The comparison site will be the distal esophagus since there     is broad consensus that the distal third of the esophagus it at core-body temperature.      For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be     marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two     groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with     indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a     nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments     from its tip, and inserted 20 cm.      Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after     induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated     increment for each age group and will be equilibrated for 5 minutes before the temperature is     recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of     measurement will depend on the initial depth of insertion, with measurements continuing until     only 2 centimeters remain in the nostril.   "
22356|NCT02992990|"     To assess whether the addition of a bladder tumor biopsy improves the level of agreement     between the pretreatment endoscopic impression and the final postoperative pathology     determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.   "
22357|NCT02992977|"     This is an open-label Phase 1 study to determine the safety and tolerability of single-agent     treatment with AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced     cancer that is refractory to standard therapies and a life expectancy of ≥6 months from the     time tissue is obtained. A minimum of 6 (≤20) subjects will be enrolled to receive every     other week subcutaneous injection of 240 μg AutoSynVax™ vaccine + 50 μg QS-21 Stimulon®     adjuvant for up to 1 year.   "
22358|NCT02992964|"     This is an open-label, single arm, multi-center, pilot study of Nivolumab in pediatric     patients with recurrent or refractory hypermutant malignancies aged 12 months to 18 years of     age. This study is to assess clinical and radiological benefits of treatment with Nivolumab     in children with hypermutated cancers, including those with bMMRD syndrome. It is our     expectation that patients with bMMRD syndrome will account for the majority of patients     enrolled on this study.   "
22359|NCT02992951|"     Surgical site infection is an infection at a place in the body where surgery has taken place,     and has been reported in around 5% of people undergoing an operation. In vascular surgery,     infection rates are as high as 30%. Methods to reduce this rate of infection should be     investigated thoroughly for their effectiveness and cost-effectiveness.      The investigators aim to conduct a research trial examining one such method. Leukomed Sorbact     is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts     with, and binds bacteria, causing them to be mechanically removed from a wound when the     dressing is changed.The trial aims to compare the effectiveness of this dressing to a     standard, non-coated dressing, in the reduction of surgical site infection.      712 patients from a number of centres across the UK will be recruited to this study. Adult     patients who are having a vascular surgery operation will be approached for entry into the     trial. The trial will be explained to them, as well as an explanation that participation is     voluntary and their operation or other aspects of their care will not be impacted in any way     should participants not wish to participate.      Participants will be randomised by computer into one of two groups - one group whose wounds     are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard     dressing. Patients will be followed up at 5-7 days and 30 days, and at 1 year. At the follow     up, their wounds will be inspected for infection, and participants will be asked to complete     short questionnaires measuring quality of life.      The trial will aim to answer a number of questions, with the primary question being does a     DACC coated dressing applied after an operation reduce the risk of an infection at the     surgery site? It will also ask whether this treatment is cost-effective and whether it     promotes satisfactory healing.   "
22360|NCT02992938|"     Remifentanil is a potent opioid widely used during the administration of general anesthesia.     There is a lot of evidence that suggest that the used of remifentanil is associated with the     development of hyperalgesia (a reduction of nociceptive thresholds). However, the mechanism     of this hyperalgesia is not fully understood.      Recently, it was demonstrated that the disruption of the Cl- homeostasis could be involved.     Interestingly, this was prevented in a murine model with the administration of Acetazolamide,     a carbonic anhydrase inhibitor. In our clinical trial we will try to determine if the     preoperative administration of acetazolamide could prevent the hyperalgesia induced by     remifentanil in patients scheduled for thyroidectomy with general anesthesia.   "
22361|NCT02992925|"     The purpose of this study is to:        -  (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of          BK1310.        -  (cohort 2) evaluate efficacy of BK1310 for all antigens (anti-PRP, diphtheria toxin,          pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared          noninferiority with co-administration of ActHIB® and Tetrabik, as well as safety, in          healthy infants.   "
22362|NCT02992912|"     Although it is usually described as an immunosuppressive modality and not thought of as     immunotherapy, there are new preclinical evidences suggesting that high-dose ionizing     irradiation (IR) results in direct tumour cell death and augments tumour-specific immunity,     which enhances tumour control both locally and distantly. Importantly, IR effects exceed the     classical cytocidal properties by also causing phenotypic changes in the fraction of     surviving cells, markedly enhancing their susceptibility to T cell-mediated elimination.     However, not all IR-induced modifications of the tumour and its microenvironment favor immune     rejection. The tumour microenvironment is populated by various types of inhibitory immune     cells including Tregs, alternatively activated macrophages, and myeloid-derived suppression     cells (MDSCs), which suppress T cell activation and promote tumour outgrowth. Chiang et al.     showed the accumulation of pro-tumourigenic M2 macrophages in areas of hypoxia present in     irradiated tumours. IR then may also induced responses that are inadequate to maintain     antitumuor immunity.      Close interaction between IR, T cells, and the PD-L1/PD-1 axis exsit and provide a basis for     the rational design of combination therapy with immune modulators and radiotherapy. Deng et     al. demonstrate that PD-L1 was upregulated in the tumour microenvironment after IR. Moreover,     administration of anti-PD-L1 enhanced the efficacy of IR through a cytotoxic T cell-dependent     mechanism. Concomitant with IR-mediated tumour regression, IR and anti-PD-L1 synergistically     reduced the local accumulation of tumour-infiltrating MDSCs, which suppress T cells and alter     the tumour immune microenvironment. Finally, activation of cytotoxic T cells with combination     therapy mediated the reduction of MDSCs in tumours through the cytotoxic actions of TNF.     Sagiv-Barfi et al, also demonstrated in 5 patients receiving atezolizumab and radiation     therapy, at least stabilization of systemic progression in all patients and a RECIST partial     response at systemic sites in 1 patient. Transient, grade 1-2 inflammatory adverse events     (fevers, flu-like symptoms) occurred with no serious immune-related toxicities. Abscopal     out-field effects of irradiation has also been described in addition to a reduction in     circulating MDSCs in a melanoma patient treated with the anti CTLA-4 ipilimumab and     radiotherapy.      Lastly, recent evidence demonstrates that loco-regional curative treatment with stereotactic     ablative radiotherapy (SABR) is a good alternative as compared with conventional 3D RT for     patients with solid tumour, with durable remissions and a low toxicity profile. Many     non-randomised studies have shown that SBRT for oligometastases is safe and effective, with     local control rates of about 80%. Importantly, these studies also suggest that the natural     history of the disease is changing, with 2-5 year progression-free survival of about 20%. For     colorectal, non-small cell, and renal cell cancers, 1-year metastasis control rates ranged     from 67 to 91%. Moreover, abscopal reponses in the setting of immune checkpoints inhibitors     and radiotherapy combinations have been made in the setting of metastatic disease event in     patients with extensive tumor burden. The goal of SABR is to deliver appropriate metastasis     directed radiotherapy while minimizing exposure of surrounding normal tissues. Interestingly,     the dose and fractionation employed modulate RT ability to synergize with immunotherapy.     Vanpouille-Box et al, showed that immune response genes were differentially expressed in     irradiated tumours by 8Gyx3 but not 20Gyx1. This highlight the interest of hypofractionated     SABR acting as a in situ tumour vaccine.      As hypofractionated SABR may, in addition to its good local control, increase the     effectiveness of anti PD-L1, investigators aimed to investigate the efficacy and the     tolerability of the combination of anti-PD-L1 antibody with SABR.   "
22363|NCT02992899|"     The tasks of the project are to map the potency and kinetics of the neurologic, autonomic     peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham     treatment, at baseline and in response to stressful traumatic scripts related to personal     traumatic events, as well as a series of other stressors.   "
22364|NCT02992886|"     The aim of this multicenter phase II study is to evaluate the response rate, local control,     disease-free survival and treatment-related toxicity of preoperative chemoradiation for     intermediate or locally advanced rectal cancer in the fit elderly.   "
22365|NCT02992873|"     Sudden cardiac death is a major health problem in the western world. In Europe alone nearly     300 000 patients are affected annually. The majority of victims suffering from an     Out-of-Hospital Cardiac Arrest (OHCA have an initial cardiac rhythm that can be treated by     means of defibrillation. In most emergency medical systems (EMS) time to defibrillation is     too long and survival averages 10 %.However, when laymen operated Automated External     Defibrillators (AEDs) are used within the first minutes, 7 out of 10 may survive.      The aim of The Scandinavian AED and Mobile Bystander Activation (SAMBA) trial is to     evaluate if a Mobile Phone Positioning system and a smartphone application will increase the     proportions of patients with an attached Automated External Defibrillator (AED) before     arrival of the Emergence Medical System (EMS). Mobile phone technology and a smartphone     application will be used identify and recruit nearby CPR-trained lay people and automated     external defibrillators (AEDs) to patients suffering out-of-hospital cardiac arrest (OHCA).     The system is currently running in Stockholm Sweden and in the Gothenburg region.   "
22366|NCT02992860|"     The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5     months after failure, representing a significant unmet medical need due to the very limited     treatment options. In this context, a specific targeting of the leukemic stem cell (LSC)     seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123     is overexpressed in AML and MDS progenitors making it an attractive target for     immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been engineered     with regard to this strategy and the current phase II trial has the aim to evaluate the     overall hematological response rate at 3 months in HMA refractory/relapsed AML and MDS     patients.   "
22367|NCT02992847|"     Several recent studies have shown an increase in the signal intensity of the unenhanced     T1-weighted magnetic resonance images in the brain of patients with normal renal functions     and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to     an accumulation of gadolinium based contrast agent. These studies were mainly conducted in     patients with primary or secondary brain tumor. Multiple sclerosis is a particular model     since it involves patients with a break of the blood-brain barrier, a long life expectancy,     and who received many injections of contrast enhancing agents. In this context, it appears     fundamental to know whether contrast agents accumulate in the brain for this disease. The     French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with     homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without     injection. The purpose of this study is to evaluate the accumulation of two commonly used     gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple     sclerosis, who received at least 5 injection of exclusively one of these contrast material.   "
22369|NCT02992821|"     Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA))     it is important to reveal the underlying cause of the disease. In special it is important to     reveal if carotid artery stenosis is present as such a finding will directly influence on     treatment and follow-up.      For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations     is the cornerstone, but computer tomography and magnetic resonance imaging may be better in     some cases. Development of high quality pocket-sized ultrasound scanners has allowed for semi     quantitatively bed-side assessment of the carotid arteries and the heart.      The investigators aim to study the feasibility and reliability of bed-side assessment of the     carotid arteries by pocket-sized ultrasound scanners in inexperienced hands and the clinical     influence of this examination when performed by experienced users.      The investigators hypothesize that a significant proportion of this patient population can be     clarified bed-side by junior doctors with no need of further imaging procedures for the     assessment of the carotid arteries and the heart.   "
22370|NCT02992808|"     In this study the investigators will try to discover whether there is a difference for any of     the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs.     human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of     androgenic hormones profile. The study question is whether using recombinant LH will result     in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using     highly purified urinary gonadotropins with hCG mimicking LH activity.   "
22371|NCT02992795|"     This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years     old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of     injury. All subjects will complete a minimum of one recording based on their assigned cohort.     Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury.     The symptomatic evaluation, physical examination, neurological baseline testing, and     BrainPulse recordings will be entered in a database to determine clinical outcome and assess     device utilization.   "
22372|NCT02992782|"     Women who have undergone breast cancer surgery may develop swelling of the arm on the side     the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This     study will examine the effect of a 12-week decongestive progressive resistance exercise with     advanced compression on breast cancer related lymphedema. Our objective is to determine if     breast cancer survivors are willing and able to wear advanced compression while exercising     and if the combination will help to reduce their lymphedema. Twenty-four breast cancer     survivors from Edmonton, Alberta will be enrolled in the one-year long study.   "
22373|NCT02992769|"     Axillary lymph node status is a vital prognostic factors in breast cancer patients and     provides crucial information for making treatment decisions.This projective observational     study is planned to identify risk factors for axillary metastases in breast cancer patients     with axillary ultrasound and to construct a nomogram to predict the risk of axillary     metastases in these patients.   "
22374|NCT02992756|"     Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve:     after at least one cycle of stimulation obtaining 0-4 oocytes.      Improve the follicular response in patients with low response, increasing the number of     follicles in subsequent cycles to treatment with growth factors.   "
22470|NCT02991508|"     This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to     identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.   "
22375|NCT02992743|"     This study is for men and women who have a type of sarcoma that has returned after being     treated, or that cannot be surgically removed. The specific type of sarcoma is Myxoid / Round     Cell Liposarcoma, also known as High Grade Myxoid Liposarcoma.      In addition to this disease patients must also have the tissue type HLA-A*02:01, HLA-A*02:05     or HLA-A*02:06, and a sample of tumor tissue must test positive for the NY-ESO-1 protein.      The study treatment is made from some of the patient's own white blood cells called T cells.     T cells are collected from the patient and sent to a laboratory to be genetically modified,     with the aim that they will be able to destroy the cancer cells.      Manufacturing the T cells takes about 1 month to complete. The T cells will be given back to     the patient by an intravenous infusion. The purpose of this study is to test whether the T     cells have an effect on the cancer and to test whether the treatment can be given safely to     patients with this disease.   "
22376|NCT02992730|"     Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death.     Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer     deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive     tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years,     this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are     more likely to die from their breast cancer as ER positive White women. Preliminary data     suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity.     To date, no study has systematically examined psychosocial, healthcare, and biological     factors that predict adherence to hormonal therapy in Black women with breast cancer. To     begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of     422 ER positive Black breast cancer patients recruited from health maintenance organizations     (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific     aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values,     etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects),     and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3)     Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that     predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in     adherence to hormonal therapy which is novel and will increase knowledge about this genetic     factor in Blacks. The study is focused on the time-period (first 3 years) when women appear     to be the most vulnerable to terminating treatment prematurely. A better understanding of     predictors of adherence in Black women may help target interventions and ultimately improve     potentially avoidable adverse breast cancer outcomes in this underserved group.   "
22377|NCT02992717|"     The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined     Delirium. The primary objective of this study is to translate the 3D-CAM into the German     language, as well as to validate its use to detect postoperative delirium in the recovery     room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening     Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical     Manual of Mental Disorders).   "
22411|NCT02992275|"     This study will examine the addition of neuromuscular electrical stimulation (NMES) on the     hip abductors during strength training and a fall prevention program for improving muscle     strength and improving balance. All individuals in this study will receive NMES to their hip     abductors and will participate in a fall reduction program.   "
22378|NCT02992704|"     Chronic Hepatitis B carriers (normal LFTs and viral load < 2 x 10^4 IU/ml are not recommended     to be treated by guidelines as they are at low risk for complications. However, it is unclear     if treatment can enhance HBsAg loss which has been shown to be associated with significantly     lower risk of complications compared to those without HBsAg loss. Consequently, this is a     proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B     carriers in a randomised open label clinical trial comparing no treatment to 24 weeks     peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary     endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on     therapy and matched to an equivalent timepoint in the control arm. The sample size     calculation is 30 patients in each arm for a 20% difference between any experimental arm and     the control arm.   "
22379|NCT02992691|"     The Dose response of three experimental toothpastes (test product 1, test product 2 and test     product 3) to remove plaque after a single brushing, compared to a positive control and     negative control dentifrice will be evaluated.   "
22380|NCT02992678|"     Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are     scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be     recruited for the study. Patients were randomized using opaque, sealed envelopes containing     random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo     (placebo group) for preventing ERCP pancreatitis.   "
22381|NCT02992665|"     The purpose of this study is to determine the impact of the use of calcium ionophore on the     ICSI outcomes in couples with severe male factor infertility. Investigators conduct a     randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in     these cases.   "
22382|NCT02992652|"     -  The investigators evaluated the role of allopurinol in prevention of post-ERCP          pancreatitis.        -  100 Egyptian patients who were candidates for ERCP were included and divided into two          groups. Group 1 (study group) included 50 patients who received two doses of allopurinol          300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50          patients who did not receive allopurinol prophylaxis.   "
22383|NCT02992639|"     To investigate weight loss effect with mild calorie restriction on circulating levels of     liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral     fat area (VFA) at L4 ≥ 100 cm²].   "
22384|NCT02992626|"     In a randomised controlled cross-over study, the influence of interacting with a dog on     children's learning performance is investigated.   "
22385|NCT02992613|"     Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS)     total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee     arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has     been postulated to provide reproducible femoral rollback and increased flexion. However,     posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to     several post-cam related problems, including post-cam dislocation, wear and breakage of post,     and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone     resection and poses a risk for intercondylar fracture of the distal femur during box     preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC)     total knee arthroplasty was introduced.      This study aims to compare the clinical results of Ultra-Congruent(UC) and     posterior-stabilized(PS) insert in bilateral total knee arthroplasty.   "
22386|NCT02992600|"     To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction     and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a     predictor of POCD and to provide reference for POCD prevention, early detection and timely     diagnosis and treatment.   "
22387|NCT02992587|"     Background:      Over the past decades there have been seen an increase in life expectancy in Denmark. One of     the consequences is that the patients who need heart surgery have a higher average age and     some of these patients have a fragile physique that increases the risks of major surgery.      In cardiac surgery, there are different types of scoring system for assessing the     preoperative risk of death associated with surgery. Among them are EuroSCORE and STS systems     the most used.      This study evaluate the preoperative risk using the frailty score system, CAF (comprehensive     assessment of frailty), based on an assessment of the patient's physical condition. If the     patient has a lower than expected physical condition, the patient is frail. The assessment of     the physical condition generated from questions about the patient's medical history and     physical activity as well as performing less physical tests, consisting of strength, balance     and walking speed.      Purpose:      A prospective observational study, who investigates how many of the patients who must undergo     heart surgery, that is frail. Then compare the patients who are frail with non-frail patients     in terms of complications, mortality and quality of life after the procedure. By use of CAF     score the patients are scored frail or non-frail. There is planned a further study which     compare degree of kidney injury in frail with non-frail patients. Our assumption is that     patients which are frail, have an increased risk of complications and longer hospital stay,     higher consumption of intensive days and more readmissions. Using frailty score in     combination with the existing score systems EuroSCORE and STS score, are believed to be a     better predictor of complications following heart surgery.      Method:      FICS study is a prospective observational study of patients undergoing cardiac surgery in the     cardiothoracic department of Rigshospitalet. Planned to enroll 600 patients over a two year     period. The study consists of various smaller physical test and questions. Which is used to     assess whether the patient is frail and not frail.      Postoperatively follow-up after 30 days with a phone call and after 12 months through danish     data register. At the both follow-up times, data are collected on the somatic readmissions /     diagnoses and vital status through the national register and review of relevant journal     notes. Afterwards comparing complications and mortality.      Who can enter:      One patients can be included if the following criteria are met: Age> 65 years, Elective or     subacute surgery, CABG (coronary artery bypass grafting),valve substitution or combination of     these      If one or more of the following criteria are met, the patient is not included in the study:      Acute surgery, Clinical unstable, Severe neuropsychiatric impairment, Uncooperative     (psychiatric diagnosis) and Re-operations.      Side effects, risks and disadvantages:      Today preoperative risk assessment are assessed by EuroSCORE. Introduction of CAF, frailty     score will not expose patients to the risk or side effect, since the course or treatment does     not change.      Economy:      There are considered that the study are economically justified, since hypothetically this     would lead to fewer readmissions, fewer days in intensive care and shorter hospital.      Acquisition:      The patients will in this trial be over 65 years old and must have completed elective or     subacute cardiac surgery. They will receive participant information and thus the opportunity     to read about the study before the first appearance.      At first appearance they meet our project assistant and get here verbal information about the     study, where also questions can be answered. Subsequently, the patients will be asked to sign     a consent form.      Publication of test results / research ethics statement:      The knowledge and results obtained through the survey will provide essential scientific     information of significance for the future course and treatment of patients undergoing     cardiac surgery with regard to the number of hospital days, intensive days and readmissions.     Thus, the investigator believes that the study is appropriate and ethically   "
22388|NCT02992574|"     Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as     well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2     tumors and negative axillary nodes is not generally warranted because of the presumed low     risk of recurrence in this population as a whole. However, in the setting of multiple adverse     prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of     recurrence documented for patients with one to three positive lymph nodes. Numerous     retrospective series have reported the outcome and patterns of failure for post-mastectomy     patients treated without radiation. Many of these series have analyzed several high risk     factors which were predictive of loco-regional recurrence wherein the role of adjuvant     post-mastectomy radiation can be considered. Some authors have used combinations of     prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and     lympho-vascular space invasion to define subgroups with more specific risks of loco-regional     recurrence than single factors alone. The current trial hypothesizes that Post-mastectomy     radiation in high risk, node negative early breast cancer patients decreases rates of     loco-regional recurrence and improves disease free survival and propose to address the     question in randomized setting.   "
22389|NCT02992561|"     Heightened levels of aggression are fuelling violent incidents at all levels, especially in     post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)     aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to     encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into     civil life. In the present study, the investigators provide an adapted version of FORNET to     former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month     follow up interviews will be administered to assess the main outcome measures recent violent     acts and appetitive aggression.   "
22434|NCT02991976|"     This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and     patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid     with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.   "
22457|NCT02991677|"     Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare     concern. It is painful, persistent, resistant to conventional pain therapies, and results in     long-term suffering and decreased quality of life for many cancer survivors. The role of     exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the     goal of identifying the mechanisms associated with this therapeutic approach to manage     CIPN-NP.   "
22390|NCT02992548|"     Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis     CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of     cardiovascular death in patients with myocardial infarction. This cardioprotective effect of     omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects.     Statin such as pravastatin is also known to have anti-inflammatory and antioxidant     properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty     acids. Erythrocyte membrane oleic acid is significantly higher in patients with acute     coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also     be related to decreased oleic acid content of erythrocyte membrane. There is no report about     the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are     recognized as therapeutic agents for reducing triglycerides, statin may affect on the     erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte     membrane FA contents including oleic acid in CKD patients.   "
22391|NCT02992535|"     Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment     with IPL.   "
22392|NCT02992522|"     This phase I study studies the side effects and best dose of venetoclax and lenalidomide when     given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that     has returned after a period of improvement or not responding to treatment. Monoclonal     antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and     spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may     work better in treating patients with B-cell non-Hodgkin lymphoma.   "
22393|NCT02992509|"     The pilot study is intended to show the efficacy of intravesical electrical stimulation in     treating overactive bladder with or without frequency and/or urgency urinary incontinence.   "
22394|NCT02992496|"     The purpose of this double-blind, controlled, randomized study is to investigate the     antidepressant efficacy of oral ketamine treatment in patients suffering from a major     depressive episode.   "
22395|NCT02992483|"     The purpose of this first in human study is to assess safety, tolerability, PK and     preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as     S64315) as single agent administered intravenously (i.v.) in adult patients with refractory     or relapsed lymphoma or multiple myeloma.   "
22396|NCT02992470|"     This study aimed to observe whether a hydrolyzed oyster extract improves liver health in     participants whose alanine transaminase (ALT) levels are1-3 fold above the normal. A total of     96 participants will be randomly allocated to active (oyster) or placebo group (1:1). Each     group will receive 750 mg of oyster extract or placebo per day for 8 weeks. Primary outcome     will be the change in ALT level and secondary outcomes will be; (1) ratios of participants     with normal ALT, aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT); (2)     the change in serum bilirubin; (3) the change in multi-dimensional fatigue inventory; (4) the     changes in serum lipids; (5) the changes in antioxidant enzymes.   "
22397|NCT02992457|"     Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated     nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in     Egypt. For decades the antiviral therapy of chronic HCV infection was based on the     administration of Interferon(IFN), initially alone and then in combination with Ribavirin     (RBV), but this regimen was effective in only 50% of patients with genotype 1, with     significant side effects.   "
22398|NCT02992444|"     This study investigates the impact real output has on peristomal skin covered by an adhesive   "
22488|NCT02991274|"     The study primary objective is to assess the concordance of T790M resistance mutation testing     from hospital-based laboratories with T790M resistance mutation testing from a central     laboratory.   "
22489|NCT02991261|"     The objective of the study is to determine the relative bioavailability, safety and     tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects   "
22490|NCT02991248|"     This study is to test whether pelvis perturbation training paired with transcutaneous spinal     direct current stimulation (tsDCS) will be effective in improving dynamic balance and     locomotor function in humans with SCI. One group will receive pelvis perturbation training     paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and     one group will receive treadmill training only.   "
22399|NCT02992431|"     In the aging population, the prevalence of chronic diseases and multimorbidity has become     common. Therefore, the planning and coordination of care have become more important. However,     it is not known what kind of treatment plan should be and what kind of patients would benefit     most of it.      This research focuses on the participatory patient care planning in primary health care. In     general, the participatory patient care planning (PPCP) aims to engage patients in self-care,     to improve the collaboration between patients and professionals and to improve the use of     resources. The present study investigates the feasibility and effectiveness of the PPCP.      The specific research questions of the present study are: Does the PPCP have an impact on the     patient's quality of life? Does the PPCP improve the quality of care in management of chronic     diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on     the use of health care services? The data consists of people aged at least 18 years living in     the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who     are recorded in in Siilinjärvi Health Care Center electronic patient record. The     participating patients are recruited from those who contacts SiiIinjärvi Health Care Center     in order to have a follow-up visit because of the treatment of their disease. This study aims     to recruit 700 patients.      The participants are allocated into the intervention group and into the control group     receiving usual care. Intervention consists of the PPCP. This includes the patient activation     questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist     measurement, weight and length) and a visit to the general practitioner who discusses and     agrees with the patient about the treatment goals and follow-up resulting in the written     PPCP.      The main out-come measures are the quality of health related life measured with the 15D; the     level of patient's activity in self-care with the Patient Activation Measurement (PAM); life     satisfaction, self-rated health, a reduction in productivity with the Work Productivity and     Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood     pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain     intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls     and referrals are measured.   "
22454|NCT02991716|"     Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected     subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using     existing, approved ECG recording devices.   "
22466|NCT02991560|"     To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic     (Athletic Tape) taping as part of the conventional physiotherapy of the lateral epicondylitis     using the results from ultrasonography and clinical tests.   "
22400|NCT02992418|"     The aim of the study is investigate the immunogenicity and safety of CYD dengue vaccine and     Tdap vaccine when both vaccines are administered concomitantly or sequentially.      Primary Objectives:        -  To demonstrate the non-inferiority of the humoral immune response to the Tdap booster          dose concomitantly administered with the first dose of CYD dengue vaccine as compared to          sequential administration, measured 28 days after Tdap booster dose        -  To demonstrate the non-inferiority of the humoral immune response to the first dose of          CYD dengue vaccine concomitantly administered with Tdap as compared to sequential          administration, measured 28 days after the first dose of CYD dengue vaccine.      Secondary Objectives:        -  To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD          dengue vaccine with the first dose concomitantly administered with Tdap as compared to          sequential administration, measured 28 days after the third dose of CYD dengue vaccine.        -  To describe the humoral immune response at baseline and 28 days after the first and          third doses of CYD dengue vaccine, in each and any group.        -  To describe the humoral immune response of Tdap vaccine at baseline and 28 days after          concomitant administration with the first dose of CYD dengue vaccine as compared to the          sequential administration, in each and any group.        -  To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each          and any injection in each group.   "
22401|NCT02992405|"     The FOCUS program (study treatment) is an established evidence-based intervention whose     redesign for families and couples dealing with serious and chronic illnesses will provide a     creative and promising supplement to the existing support services at Cedars-Sinai Medical     Center. All participants will receive the 10-weeks of 75-minute weekly study treatment, but     will be split into two groups, the immediate treatment group and the wait list treatment     group, who will receive the study treatment after the immediate 10 weeks of treatment is     completed.   "
22402|NCT02992392|"     With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been     developed in which phospholipid liposomes are delivered to the tear film via the surface of     the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte     application on the lipid and stability of the tear film in dry eye patients.   "
22403|NCT02992379|"     To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw     exercise together with stabilizing splints for treatment of TMJ anterior disc displacement     without reduction   "
22404|NCT02992366|"     To evaluate the clinical and radiographic outcomes of socket shield technique compared with     conventional immediate implant placement.   "
22405|NCT02992353|"     In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and     39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical     operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is     performed in clinical operation with the aim of decreasing postoperative complications     morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical     injury. There are some trials regarding two-port VATS versus three-port VATS versus four-port     VATS or single-port VATS versus three-port VATS. However, there is no prospective randomised     controlled trial regarding Single-port versus two-port versus three-port video assisted     thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that single-port and     two-port VATS were feasible and safe through the trial, and we hope the results of our study     will provide a high level of clinical evidence for choosing the best operative approach in     VATS.   "
22406|NCT02992340|"     .The study intends to evaluate the objectives in patients with advanced or metastatic biliary     tract cancer who have not received systemic therapy for advanced/metastatic disease.      Primary Objectives:      Phase 1B      • To determine the maximum tolerated dose (MTD), as determined by dose-limiting toxicities     (DLTs), and to characterise the safety profile of Varlitinib in combination with Gemcitabine     and Cisplatin.      Phase 2      • To access the efficacy of Varlitinib in combination with Gemcitabine and Cisplatin in terms     of objective response rate (ORR) by 24 weeks (ORR based on RECIST v1.1).   "
22407|NCT02992327|"     The overall research aim of this pilot study is to determine if the structural brain protein     calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to     accurately identify patients who will have more severe symptoms and reduced neurocognitive     functioning after sustaining a concussion. Concussion is also referred to as mild traumatic     brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout     this application.   "
22408|NCT02992314|"     Patients taking chemotherapeutic agents often do not comply well with their dosing regiment     since many of these medications cause a metallic taste in the mouth. The primary intent is to     determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth     associated with various chemotherapeutic agents. This clinical study a randomized,     double-blind, single-treatment, parallel design with a placebo as the control. The duration     of the trial will be 1 month.   "
22491|NCT02991235|"     A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label     extension study.   "
22409|NCT02992301|"     Aim 1: To determine whether therapy with Alirocumab, compared to pre-treatment, will     effectively improve carotid atherosclerotic plaque characteristics by reducing Ktrans and     LRNC size. To achieve this goal, we will (a) enroll 30 subjects who are intolerant to high     intensity statin therapy and only able to tolerate low potency statin or low weekly dose of     high potency statin and have LDL-C ≥100 mg/dl; (b) initiate alirocumab at 150mg     subcutaneously injection every 2 weeks; (c) perform carotid DCE-MRI scans at baseline, 3, 6     and 12 months; (d) perform quantitative analysis for vascular inflammation and plaque LRNC     volume and other plaque characteristics; (e) compare vascular inflammation and LRNC volume     between pre- and post-alirocumab at 3, 6 and 12 months.      Aim 2: To examine associations between reductions in atherogenic lipids (LDL-C, Lp(a),     non-HDL-C) and changes in atherosclerotic plaque characteristics. To achieve this goal, we     will (a) perform laboratory assessments of lipids, lipoproteins and apo-lipoproteins at     baseline and during the study; (b) compare lipids, lipoproteins and apo-lipoproteins levels     between pre- and post-alirocumab; (c) correlate reductions in atherogenic lipids with changes     atherosclerotic plaque characteristics.   "
22410|NCT02992288|"     The objective of the study is to find the optimal dose of once daily oral neladenoson     bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with     reduced ejection fraction (HFrEF).   "
22412|NCT02992262|"     Pediatric emergency department (PED) physicians frequently encounter children with symptoms     that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP)     such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED     physician, is considered an essential modality for assessment of the optic disc and the     diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient     compliance, the ability to open the eyelids, the absence of opacities in the ocular media and     a sufficiently large pupillary aperture. Hence, different levels of PED physician training,     lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis     and severe photophobia may hinder direct fundoscopic evaluation.      In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic     examination. The investigators aim to evaluate the yield of optic disc height as measured     with ocular point of care ultrasound to detect optic disc swelling in comparison to     ophthalmologic examination as the gold standard.   "
22413|NCT02992249|"     This is a prospective uncontrolled observational study to evaluate clinical outcomes     following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for     closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting     for closure, and associated skin graft donor sites, in patients who lack adequate available     skin to harvest for conventional grafting. Treatment with the ReCell device may be performed     as part of a single operative procedure, or multiple staged procedures as deemed clinically     necessary. Adverse events associated with the use of the ReCell device/cell suspension will     be documented. Subjects will be followed for 1 year following ReCell treatment.   "
22414|NCT02992236|"     Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on     renal function and perfusion in 16 healthy subjects.   "
22415|NCT02992223|"     Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose     chemotherapy followed by autologous stem cell transplant could improve prognosis in patients     affected by relapsed/refractory aggressive non Hodgkin lymphoma   "
22416|NCT02992210|"     Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex     multimodel therapy and therefore, novel approaches are urgently needed. The investigators are     attempt to treat these diseases using T cells genetically modified with a 4th generation     lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9     domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill     tumor cells through the recognition of GD2, a surface protein expressed at high levels on     many types of tumors but not on normal tissues. This study will evaluate the side effects and     effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.   "
22417|NCT02992197|"     Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines     work remarkably well in high-income countries, but for unclear reasons they underperform in     low-income countries. A double-blind, randomized control trial will be performed to evaluate     whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can     improve immune responses among infants in Dhaka, Bangladesh.      Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6     and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum     rotavirus-specific IgA responses to determine vaccine immunogenicity.   "
22418|NCT02992184|"     The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive,     Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase     chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from     patients with chronic hepatitis C and non-infected controls.   "
22419|NCT02992171|"     This study seeks to develop and pilot-test an oncology nurse-led care management intervention     to meet the primary palliative care needs of patients with advanced hematologic malignancies.   "
22420|NCT02992158|"     The goal of this project is to train community mental health therapists in behavioral     activation (BA) treatment for major depressive disorder and then to conduct a study examining     the feasibility of evaluating the effectiveness of BA in this setting.   "
22421|NCT02992145|"     This study aims to compare between androgens level (serum total and free testosterone) in     women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).   "
22422|NCT02992132|"     To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and     aggression after 12 weeks of treatment   "
22492|NCT02991222|"     The objective of the study is to determine the relative bioavailability, safety and     tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects   "
22423|NCT02992119|"     Targeted malaria elimination (TME), which comprises appropriate case management by village     health workers, vector control and mass drug administration, is currently being implemented     through pilot projects in selected villages in the Greater Mekong Subregion (GMS) and the     scale-up of the intervention to the regional level are underway. Based on mathematical     modelling, extending the post-TME parasitaemia-free period in the majority of villagers for     as short as 200 days will substantially increase the chances of achieving the interruption of     malaria transmission. Immunogenicity of RTS,S is greater in older children, and the short     term malaria protective effect is stronger than the overall effect assessed over 1-2 years.     Addition of mass RTS,S/AS01E vaccination to the TME arsenal could provide this much needed     additional protection.      Currently there are no safety and immunogenicity data for the use of RTS,S/AS01 in Asian     populations. This trial will generate the required data for the use of this vaccine in Asian     populations. For integration with the current TME activities, which provide mass drug     administrations at months M0, M1, and M2, it would be most efficient and practical to provide     the vaccine at the same intervals. To address a two round intervention (M0, M2) where a three     round intervention is not feasible, one study arm will look at the immune response generated     by only two doses of vaccine and antimalarial medications. Recent evidence suggests that a     vaccination schedule which includes a fractional dose of RTS,S/AS01 (1/5th of the standard     dose) could be similarly or more protective than a schedule with three standard full doses,     while requiring less vaccine and resources. The trial therefore includes study arms which     will assess the safety and immunogenicity of fractional dose schedules.      Each participant will be randomized into one of the following study arms in a ratio of     20:20:30:30:30:30:30, as follows:        -  RTS,S/AS01B Fractional dose group (Group 1)        -  Double RTS,S /AS01E Fractional dose group (Group 2)        -  RTS,S/AS01E Standard dose group (Group 3)        -  RTS,S/AS01E + DHA-PIP+PQ Standard dose group (Group 4)        -  RTS,S/AS01E Fractional dose group (Group 5)        -  RTS,S/AS01E + DHA-PIP+PQ Fractional dose group (Group 6)        -  RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group (Group 7)   "
22455|NCT02991703|"     Arterial stiffness is an important marker of cardiovascular risk. It is measured by pulse     wave velocity. The reference device to measure pulse wave velocity is the Sphygmocor which     uses applanation tonometry. It is used in adults and children. An easier method called     pOpmètre using saturation sensors is validated in adults but not in children. The objective     of this study is to compare the pulse wave velocity values measured with the pOpmètre® with     those of the SphygmoCor® to validate the pOpmètre in children between 4 and 8 years old.   "
22424|NCT02992106|"     The rising worldwide prevalence of obesity and its subsequently rising incidence of     concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the     health care and associated health care costs of future generations. Obese pregnant women are     a growing population of interest because their offspring is at risk for childhood obesity, an     adverse metabolic and inflammatory profile and possible endothelial dysfunction. However,     strong evidence is still lacking regarding the hypotheses on the early origin of these     long-term health consequences.      Consequently there is no comprehensive data available on the contribution of changing     maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse     metabolic and endothelial programming of the offspring.      The investigators of this study want to provide additional data on the body composition,     metabolic and inflammatory state as well as endothelial function of children of obese     pregnant women women and compare the outcome with children born from normal weight women.     Furthermore, the investigators of this study will stratify the obese pregnant women into 3     groups: women who did not underwent an intervention, women who underwent a weight changing     intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent     bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the     diverse groups of participating children, except the control group, there will be a certain     grade of endothelial dysfunction, even if there was a normalization of weight, insulin     sensitivity and inflammation before conception or delivery in the mother.   "
22425|NCT02992093|"     The type-2 diabetes mellitus（T2DM）, metabolic syndrome, cardiovascular disease complications     induced by polycystic ovary syndrome(PCOS) with insulin resistance(IR）, which become serious     threat to public health. In this observational study, obese patients with PCOS,nonobese     patients with PCOS, PCOS patients with impaired glucose tolerance（IGT）, PCOS patients with     type-2 diabetes mellitus（T2DM）, and healthy volunteers would enrolled into this study,     through the Liquid Chromatography-Mass Spectrometry coupled to Mass Spectrometry（     LC-MS/MS）and Rapid Resolution Liquid Chromatography（RRLC） and Quadrupole Linear     Trap（QTRAP）Mass Spectrometry coupled to Mass Spectrometry （MS/MS）analysis of serum samples     collected from PCOS patients and healthy volunteers to screen the biomarker of diagnosis for     PCOS with insulin resistance, to explore the correlation between traditional chinese medicine     （TCM） syndrome（phlegm, kidney yin deficiency, kidney yang deficiency, qi stagnation and blood     stasis，dampness-heat of liver channel）and metabolites of PCOS.   "
22426|NCT02992080|"     The aim of our study is to assess miRNAs expression profiles in the circuling blood of     patients with cystic fibrosis and highlight signatures that could reflect the pulmonary     status of patients   "
22427|NCT02992067|"     To establish a predicting system on axillary lymph node metastasis based on peripheral blood     CK19mRNA and contrast-enhanced ultrasound.   "
22428|NCT02992054|"     Randomized controlled trial for assessing the effects resulting from an innovative     occupational program using new technologies (KODRO) on nursing home residents' quality of     life      Context : improving quality of life (QOL) for the nursing homes residents (NHR) is a national     priority (2010 report from French ANESM).   "
22429|NCT02992041|"     The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug     candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,     placebo-controlled study.   "
22430|NCT02992028|"     1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the          shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of          rotator cuff tear.           As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the          rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear          annually more than 300,000 have been performed according to US statistics.           Rotator cuff repair is a successful procedure, both objectively and subjectively, with          regard to pain relief and functional outcome.        2. postoperative pain management after rotator cuff repair Shoulder surgeries are          associated with a level of postoperative pain requiring opioid use for several days. The          opioid requirements after shoulder surgery have been reported to be similar to those          required after gastrectomy or thoracotomy, which might cause several opioid-related side          effects, such as nausea and vomiting, pruritus, urinary distention, and constipation.          Although the introduction of arthroscopy has reduced postoperative pain, a considerable          proportion of patients suffer from moderate to severe acute postoperative pain, as its          benefit is typically apparent after a few days. Consequently, proactive pain control is          also required during the first 24-48 h after arthroscopic shoulder surgeries, just like          in open surgeries. Adequate pain management during the immediate postoperative period is          not only important for patient satisfaction and well-being, but also for facilitating          postoperative rehabilitation and preventing persistent postsurgical pain.      Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after     otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to     have anti oxidant action, and fewer side effects.      However, there is no report about the analgesic effect of vitamin C after arthroscopic     rotator cuff repair.      The purpose of this trial was to compare the effects of a intravenous vitamin C injection on     postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator     cuff repair.   "
22493|NCT02991209|"     The overall purpose of the study is to evaluate the effect of 12 months testosterone     replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in     order to reduce the risk of cardiovascular disease.      The primary study objective is to evaluate changes in insulin sensitivity. The secondary     study objective is to evaluate changes in the prevalence of metabolic syndrome, body     composition, systemic inflammation and symptoms of testosterone deficiency.   "
23401|NCT02979327|"     This study is designed to investigate the cardiovascular response (blood pressure, heart     rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall     in healthy adults.   "
22432|NCT02992002|"     The study investigates the influence of a clinically indicated fluid challenge on     end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data     will be collected before, during and after infusion of 500 ml of crystalloid solution in     mechanically ventilated patients on an operative intensive care unit.   "
22433|NCT02991989|"     Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength     declining up to twice as fast as muscle size. This may eventually lead to loss of     independence if tasks of daily living become too strenuous to be performed safely. Exercise     is recognized as a safe and effective means to counteract muscle loss during aging, however     access to gym equipment may be logistically challenging or unpalatable to older adults. This     research is designed to investigate the effect of 28 days of home-based leg exercise that     doesn't require exercise equipment or supervision (exercise snacking), accompanied with a     daily protein supplement in the form of commercially available yogurt, on the skeletal muscle     health (i.e. function and size) of independent, community-dwelling older adults. To achieve     this, two groups will be compared; one group will undertake exercise snacking and consume a     150 g yogurt with the breakfast meal for four weeks, with the second group only receiving the     daily yogurt with no exercise snacking.   "
22435|NCT02991963|"     This is an observational study (case-control study) aiming to identify risk factors for     malaria infection in health centers or malaria posts or district hospitals in Buntharik     District and Nachalui District, Ubon Ratchathani Province, Thailand.      This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases)     subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will     be done at each study site.      CASE (Malaria positive) subject will go through the following;        1. Enrollment visit (Day 0)           1.1 Blood collection of three dried blood spots, and malaria slide. In district          hospitals in individuals >14 kg: additional 10ml venous blood will be collected.           1.2 A survey questionnaire which includes patient demographics, information on malaria          treatment, bed net use and possible risk factors for acquiring malaria, as well as          questions about their travel and usage of mobile phones will be administered.        2. Follow up visits (if fever plus Day 42 (+/-3))      2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals:     additional 0.5ml venous blood will be collected.      2.2 Short survey questionnaire including questions on symptoms, travel and possible risk     behaviors since enrollment will be administered.      CONTROL (Malaria negative) subject will go through the following;        1. Enrollment visit (Day 0)           1.1 Blood collection to confirm negative malaria slide. In district hospitals:          additional 0.5ml venous blood will be collected.           1.2 A survey questionnaire including patient demographics, information on any recent          malaria treatment they may have taken, bed net use and possible risk factors for          acquiring malaria, as well as questions about their travel and usage of mobile phones          will be administered.        2. Follow up visit: No follow up visit   "
22436|NCT02991950|"     Prospective randomized study of patients with infertility candidates to Assisted     ReproductiveTechniques (ART), screened for all inclusion and exclusion criteria, submitted to     ART cycle with or without low molecular weight heparin (LMWH) administration. Aims of the     study are to evaluate, primarily, pregnancy rate/embryo transfer, secondarily take home     babies/embryo transfer, implantation rate, and the role of thrombophilic factors   "
22437|NCT02991937|"     This is a randomized controlled trial of 190 subjects comparing non-operative management with     antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is     that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis     in children. The primary outcome will be survey scores on the Pediatric Quality of Life     Inventory (PedsQL) Generic Core Scale Parent-proxy report. Secondary outcomes will include     child scores on the PedsQL; length of stay; immediate, 1-week, 2-week, 30-day, and 60-day     success of non-operative management; readmission rates for both groups; and long-term     complications over one year.   "
22438|NCT02991924|"     The purpose of this study is to investigate risk factors for mediastinal lymph node     metastasis in potentially operable non-small cell lung cancer in order to find indications     for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound     guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with     bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging.     CT and PET/CT findings, histologic types and other risk factors will be analyzed. The     investigators develop the prediction method for mediastinal metastasis.   "
22439|NCT02991911|"     The purpose of this study is to assess the safety and tolerability, describe the     dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum     administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726 in     subjects with mCRPC who have received prior treatment with abiraterone or enzalutamide, with     or without a prior taxane-based chemotherapy in the mCRPC setting.   "
22440|NCT02991898|"     This is a single center pilot study of a non-myeloablative umbilical cord blood transplant     for the treatment of a hematological malignancy with a single infusion of T regulatory (Treg)     given shortly after umbilical cord blood transplantation and supported with ultra-low dose     (ULD) IL-2 for 4 weeks. The goal of the study is to demonstrate the feasibility and safety of     giving ULD IL-2 to support in vivo Treg survival and help with the design of future larger     scale studies.   "
22444|NCT02991846|"     Prospective, observational, multicentre, spontaneous, non-interventional study This study     will evaluate all consecutive patients who develop chronic graft-versus-host disease,     reported by the Italian GITMO centers according to a standardized Web platform for real-time,     onsite data collection. The platform for data collection will be based on a software     prototype developed by the Clinica di Ematologia di Ancona Transplant Center for the     management of patients with chronic graft-versus-host disease. This software has been     integrated with algorithms that automatically determine: severity of chronic     graft-versus-host disease and overall response according to the 2015 NIH consensus criteria.   "
22445|NCT02991833|"     The aim of this randomized controlled clinical trial, prospective study is to developing a     new incontinece care product for controlling the fecal and urinary incontinence and to     examine the effect of this new product on prevention of perineal dermatitis.   "
22446|NCT02991820|"     This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct     laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance     of users. This will involve the use of an intubating pediatric manikin to assess various     aspects of endotracheal intubation by experienced and inexperienced users.   "
22447|NCT02991807|"     Phosphatase and TENsin homolog (PTEN) gene germline mutations are associated with a spectrum     of clinical manifestations characterized by neurocognitive deficits, intellectual disability,     autism symptomatology, skin lesions, macrocephaly, hamartomatous overgrowth of tissues, and     an increased risk of cancers. Investigators are conducting research to evaluate the potential     safety and efficacy of RAD001 (everolimus) in this patient population, and the potential     neurocognitive benefits from treatment with RAD001 or placebo for a six month period. The     investigators hope this trial will lead to a better understanding of PTEN and to new forms of     treatment that may benefit children and adults with PTEN in the future.   "
22448|NCT02991794|"     The aim of the study is collecting clinical data on the learning curve of different surgeons     using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.   "
22449|NCT02991781|"     This study will develop and experimentally test the efficiency of a neurofeedback training     protocol vs. varenicline use for smoking cessation.   "
22450|NCT02991768|"     The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will     be effective and safe for kidney transplant patients, allowing them to continue with MPA     medication.   "
22451|NCT02991755|"     The purpose of this study is to determine whether the use of 5-0 prolene during repair of     linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0     fast absorbing gut (both SOC).   "
22452|NCT02991742|"     Contrast media-induced nephropathy following diagnostic and therapeutic cardiac     catheterization.   "
22453|NCT02991729|"     The investigators aim to assess whether use of a novel, tablet-based computerized decision     aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit     in improving patient knowledge and decreasing decisional conflict.   "
22458|NCT02991664|"     The aim of this clinical trial was to compare the clinical performances of a glass ionomer     restorative system with a micro hybrid resin based composite in extended sized class II     cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative     system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). Restorations were     evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria.     Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).   "
22555|NCT02990572|"     The purpose of this registry is to find members of the Plain Community who are interested in     participating in future medical research studies. Having a registry makes it easier to     contact and offer study participation to individuals who are appropriate for a new research     study based on their own and their family medical history. Studies will focus on increasing     knowledge about disorders affecting those who are Amish and Mennonite.   "
22459|NCT02991651|"     Patient selection: a) Pathological confirmation of non-small cell lung cancer without     activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion)     with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant     women are excluded; e) Informed consent.      Pretreatment evaluation: a) Medical history and physical examination; b) Hepatic and renal     function (bilirubin, aspartate aminotransaminase, creatinine); c) Preoperative staging     evaluation including CT-chest or PET/CT scan;      Treatment plan: Three dose levels of IRX4204 and erlotinib will be studied using     intra-patient dose escalation for dose levels 1 and 2. These study agents will be     administered orally until progression of disease, unacceptable toxicities, activation of a     phase II study of the combination, or exhaustion of the IRX4204 drug supply.      Evaluation on study: Adverse events will be graded on a scale of 0 to 5, using the Common     Terminology Criteria for Adverse Events (CTCAE) v. 4.0. Efficacy will be assessed using the     RECIST v1.1 criteria based on CT-chest or PET/CT scan after 8 weeks of study treatment.   "
22460|NCT02991638|"     Efficacy and Safety of ibrutinib in patients with chronic lymphocytic leukemia and other     indolent B-cell lymphomas who are chronic hepatitis B virus carriers or occult hepatitis B     virus carriers   "
22461|NCT02991625|"     Drugs used for managing chronic pain have not proven to be effective and chronic pain     continues to cost Canadians $60 billion a year without truly helping those who suffer. The     study proposes to investigate the factors related to a person that can enhance or reduce the     effectiveness of pain treatments in people suffering with chronic pain. Treatment response to     pain killers in a person may be related to their brain, genetics, social, and psychological     makeup. The investigators aim to study these factors to identify and develop feasible and     robust indicators based on a person's biological makeup (also called biomarkers). These     biomarkers will allow doctors and researchers to predict more accurately which treatment and     prevention strategies for a particular disease will work in which groups of people. These     measures will offer new opportunities for improving treatment such as by tailoring treatment     to meet the specific needs of each patient based on his/her biological and psychological     makeup. Towards the specific aim, data will first be collected in several experimental     domains for studying treatment expectations (cognitive, psychosocial, brain-related,     genetic). These 'experimental' data will be compared between chronic back pain (CBP) and     healthy participants to yield new understanding of the factors that govern treatment     response. At the end of experimental data collection, the investigators will collect data in     the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of CBP     participants will receive a mock drug (placebo disguised as an approved pain treatment) and     another subset will provide pain ratings only and hence serve as a waiting list control for     the placebo trial. Data will be studied in steps to understand factors that mediate treatment     outcomes and finally the investigators will use advanced computational tools used for big     data analysis and aim to identify factors that can be used as biomarkers and precision     medicine tools.   "
22462|NCT02991612|"     The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment     of cirrhotic gastroesophageal variceal bleeding.   "
22463|NCT02991599|"     This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune     persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three     injections at months 0, 1, and 6 in methadone maintenance treatment patients.   "
22464|NCT02991586|"     Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal     ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health     resources, coupled with the suffering of families who feel helpless and difficulties in     handling.      The purpose of the study is to evaluate the effectiveness of a dialectical behavior therapy     (DBT) for parents of adolescents with IE who are in treatment in the different network     devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are     the development of communication skills, validation and crisis management as well as increase     understanding and competence of the pathology.      To evaluate the effectiveness of the DBT family group intervention, it is compared with a     group of non-treatment or treatment as usual (outpatient treatment and parents without     children specific group treatment). The DBT intervention will begin with two individual     sessions with parents of patients and 10 theoretical and practical seminars in group format     (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be     added to standard treatment that a patient with IE receives in the investigative devices.      The result of these interventions will be measured after the end of treatment and after 6 and     12 months after the treatment ends. The variables considered are family communication,     cognitive skills, emotional and behavioral coping clinical in parents and as indirect     measures of change in adolescents health resources used as , suicidal gestures, self-harm or     aggressive behavior.   "
22465|NCT02991573|"     Damage to teeth from decay or previous old silver fillings can be repaired with     tooth-coloured filling materials that stick to the tooth. These materials have been around     for some years and have become more sophisticated; with greater ease of placement by the     dentist and better durability for the patient. The fillings are designed to be used in     combination with a specific glue (adhesive) that is designed to stick to the different parts     of the tooth to provide a good seal, the outer enamel and the inner dentine.      This study will examine the performance of a state-of-the-art modern tooth coloured filling     material (Ceram X) in combination with an existing adhesive (control adhesive) and a new     adhesive (Prime & Bond Universal) used in two different techniques; both of which are known     to work but one is easier to apply. This results in three treatment groups.      At the start of the study, the test material Prime&Bond Universal is CE-marked, as are all     other medical devices used. Thus, this study is not conducted to meet any regulatory     requirements. The rationale of this study is the extension of knowledge primarily concerning     the clinical performance of Prime&Bond Universal in molars.      Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75     restorations in total) to assess the performance of the materials in a comparative design.     The study restorations will be monitored for a period of 18 months (with the option to extend     the evaluation period to 48 months).      After placement of restorations under controlled clinical conditions, the primary objective     of the study is the determination of post-operative sensitivity and pulp vitality, marginal     adaptation and staining of margins of the restorations. In addition, fracture of material and     retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be     determined as well as the failure rate as defined by the ADA.   "
22467|NCT02991547|"     The purpose of this study is to find out more information about patients who have cancer     (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated     with chemotherapy and radiation but have not had surgery. The study will follow patients for     5 years to monitor for their cancer and to see how the standard medical care affects the     daily life of patients.   "
22468|NCT02991534|"     Background: Women Veterans are the fastest growing segment of Veterans Health Administration     (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist     in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety,     and mental health comorbidity are disproportionately high among women Veterans. Furthermore,     a high rate of women Veterans' attrition from VA care, along with organizational barriers to     care, substantiate that organizational changes are needed in order to engage and retain women     Veteran VHA users in evidence-based, patient-centered care.      Objectives: The Enhancing Mental and Physical health of Women through Engagement and     Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing     personalized, proactive, patient-centered care models, and Transformational Strategy 7.2.g     by implementation of innovative care models in women Veterans' health care. The EMPOWER     QUERI Program is designed to improve women Veterans' engagement and retention in     evidence-based care for three high priority health conditions, i.e., prediabetes,     cardiovascular, and mental health. To achieve this impact goal, we propose a cohesive     portfolio of projects with the following aims: (1) To use an evidence-based implementation     strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement,     and systematic evaluation of complex implementation processes in order to enrich     organizational capacity for innovations in women Veterans' VHA health care; (2) To implement     personalized, proactive, patient-centered innovations in VHA women's health that are     acceptable, feasible, satisfactory, relevant, and effective for both providers and patients,     thereby encouraging women Veterans' engagement and retention and sustainability of the     innovations; and, (3) To generate implementation playbooks for our partners that are     scalable and serve as guidance for future implementation of a broader array of evidence-based     women's health programs and policy.      Methods: Three projects will be conducted by an experienced multidisciplinary team.     Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs is a one-year QI     project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans with     prediabetes will select an in-person, peer-led or online gender-specific, evidence-based     diabetes prevention program to address their risk behaviors and health conditions.     Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans will     increase identification of CV risk among women Veterans, enhance patient/provider     communication and shared decision-making about CV risk, and provide a supportive, coordinated     health coaching intervention to facilitate women Veterans' engagement and retention in     appropriate health services. Implementation of Tailored Collaborative Care for Women     Veterans will evaluate implementation of an evidence-based collaborative care model tailored     to enhance provider- and system-level capabilities to address women Veterans' anxiety and     depression treatment needs, thereby improving organizational primary care-mental health     integration (PC-MHI) effectiveness and women Veterans' engagement and retention in PC-MHI.     Both implementation research studies will use a modified stepped wedge design and will apply     the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed     methods implementation evaluations will focus on investigating primary implementation     outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder     engagement will be prioritized. Program-wide organizational-, provider-, and patient-level     measures and tools will be utilized to enhance synergy, productivity, and impact. As a     coherent program of women's health implementation research and quality improvement, the     proposed EMPOWER QUERI will constitute a major milestone in achieving BPE strategies and     realizing women Veterans' engagement and, ultimately, empowerment in our VHA system.   "
22469|NCT02991521|"     This research study aims to improve the standard exam called Focused Assessment with     Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an     abdominal bleed. The study will see if having patients roll on their right side improves the     FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients     with bleeding.   "
22471|NCT02991495|"     In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks     occurring concurrently and the risk of further spread through the African continent and even     to Asia, was larger than the available supply. In this situation, the World Health     Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever     vaccine as a dose-sparing strategy. These recommendations were based on limited number of     clinical trials and additional studies should assess the applicability of the fractional dose     to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the     performance of the fractional dose in young children and populations in Africa including     those with HIV.      This study aims to respond to some of the research questions that would allow broadening the     recommendations on the use of fractional doses of yellow fever vaccine in emergency     situations. The study will be conducted in Uganda and Kenya and the main objective is to     assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose     compared to full dose for each WHO-prequalified manufacturer. As secondary objectives the     study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and     persistence of protective antibody levels; describe the geometric mean titre and the change     in neutralizing antibody on Day 28 days after vaccination with fractional and full doses; and     assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after     administration of fractional and full doses.      The study consists of a randomized non-inferiority trial. The study aims to start in April     2017 in the two sites and aims to recruit 960 adults. Results for the main outcome will be     reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for     the studies in children and HIV positive adults.   "
22472|NCT02991482|"     Trial comparing standard treatment (chemotherapy) with pembrolizumab treatment in patients     with advanced pretreated malignant mesothelioma.   "
22473|NCT02991469|"     Primary Objective:      To describe the pharmacokinetic (PK) profile of sarilumab in patients with sJIA in order to     identify the dose and regimen for continued development in this population.      Secondary Objective:      To describe:        -  The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients          with sJIA.        -  The long term safety of sarilumab in patients with sJIA.   "
22475|NCT02991443|"     Parents of children with chronic diseases often report increased level of stress and anxiety.     The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)     intervention on stress and anxiety of parents of children with inflammatory bowel diseases     (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.     30 parents will participate. The efficacy of the intervention will be assessed by 3 validated     questionnaires which will be filled by each participant prior to intervention, at the end of     intervention and 3 months following interventions.   "
22476|NCT02991430|"     This study will assess the efficacy of a neuromodulation device for the treatment of episodic     migraine headache.   "
22477|NCT02991417|"     This clinical study is conducted to assess the safety and immunogenicity of a Clostridium     difficile vaccine (CDVAX) in healthy adult volunteers.   "
22478|NCT02991404|"     Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either     multimodal single injection adductor canal block with sham infusion catheter or continuous     infusion of local anesthetic (control) for postoperative analgesia.      Primary end point is pain scores at 30 hours post performance of block procedure.   "
22479|NCT02991391|"     This cross-sectional survey study is intended to describe the characteristics of adults in 4     US states with regards to respiratory symptoms and tobacco exposure, utilizing an existing     state-administered, CDC overseen Behavioral Risk Factor Surveillance System telephone health     survey. The primary goal of study is to describe the sociodemographics, health behaviors, and     presence of chronic diseases in persons with or at risk of having chronic obstructive     pulmonary disease.   "
22480|NCT02991378|"     This study is about early intervention for preschool children with emotional and stress     related disorders. To develop a set of program that could be used in district hospitals for     early intervention of preschool children with emotional and stress related disorder or     problems.   "
22481|NCT02991365|"     Obesity if known to be associated with brain insulin resistance in humans. This condition has     not only implication for the brain but also for whole-body energy homeostasis. Research in     rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The     current project will test this hypothesis in humans. Therefore, brain insulin sensitivity     will be assessed by fMRI in combination with intranasal insulin administration, using an     established protocol. Furthermore, effects of daily administration of insulin nasal spray     (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.   "
22482|NCT02991352|"     Treatment of vascular malformations requires the placement of a needle within anatomically     non well defined, pathological vessels, which may be as small as 1 mm, with the current state     of the art relying exclusively on two dimensional fluoroscopy images for guidance. The     investigators hypothesize that the combination of stereotactic image guidance with existing     targeting methods will result in faster and more reproducible needle placements.   "
22483|NCT02991339|"     The investigators were aiming to evaluate whether dexamethasone administration accelerates     the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy     liver failure and its safety in the subjects who developed elevated serum total bilirubin.   "
22484|NCT02991326|"     This study aim to contribute with the investigation of the therapeutic effect of osteopathic     manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with     temporomandibular disorder who make use of occlusal splints.   "
22485|NCT02991313|"     The purpose of this trial is to assess acute safety and performance of the Multi-electrode     Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the     treatment of Persistent Atrial Fibrillation.   "
22486|NCT02991300|"     The data registry will increase the knowledge of outcomes for treatment of focal cartilage     defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring     of the clinical safety and performance of the device and surgical implantation kit   "
22494|NCT02991196|"     This trial is being performed in two parts: Dose Escalation and Dose Expansion.      The primary objective for the Dose Escalation part is to determine the safety and     tolerability at different doses of DS-8273a administered in combination with nivolumab and to     identify the dose combination for the Dose Expansion cohort in subjects with mismatch repair     (MMR)-proficient advanced colorectal cancer.      The primary objectives for the Dose Expansion part are:        -  To further evaluate the safety and tolerability of DS-8273a administered at the selected          dose in combination with nivolumab in subjects with MMR-proficient advanced colorectal          cancer        -  To evaluate preliminary anti-tumor activity of DS-8273a plus nivolumab administered at          the selected dose in subjects with MMR-proficient advanced colorectal cancer   "
22495|NCT02991183|"     Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice     and accept difficult thoughts and emotions. ACT also helps people to identify what they value     in life (e.g. a good relationship with their partner) and make changes to their behaviour to     promote these values. Carers of people with dementia may experience reduced wellbeing     associated with their role. Those whose wellbeing is greater than previously are said to be     'flourishing'.      Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group     intervention for carers of people with dementia.      Methods: Participants will include adult carers of people with dementia. Study participants     will be identified from two older people community mental health teams. Informed consent will     be sought prior to group invitations being sent out. There will be two groups in total (12 in     each group) and both groups will attend three 2.5 hour sessions of ACT. All participants will     complete questionnaires at the beginning and 21 days later (asking questions about their     thoughts and feelings, flourishing and about being a carer). Eight group participants will be     invited to a focus group to understand what they found more helpful and less helpful.      Applications: Results from this study will potentially provide useful information to enable a     further study with more participants to be conducted. The outcomes of this study will be     shared with older people community mental health teams, dementia and carer specialist groups     and potentially published in a relevant journal.   "
22496|NCT02991170|"     Patients with myocardial infarction related potential malignant ventricular arrhythmia have     high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy     of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG)     Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular     arrhythmia at the same time. The observation indexes include the morbidity of potential     malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term     after CABG surgery.   "
22497|NCT02991157|"     This prospective observational study will assess the regional cerebral oxygen saturation and     cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine     administration for the prevention/management of cerebral vasospasm.   "
22498|NCT02991144|"     A Phase 1/2, open-label dose-finding safety study of single ascending doses of DTX301 in     adults with late-onset OTC Deficiency   "
22499|NCT02991131|"     This open-label, prospective, multi-center, non-interventional, observational, parallel     cohort study intends to provide real life data on the treatment duration, effectiveness and     safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real     practice setting.   "
22500|NCT02991118|"     The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo     in patients with high cardiovascular risk and elevated LDL cholesterol not adequately     controlled by their current therapy.   "
22501|NCT02991105|"     Cancer remains a major cause of morbidity and mortality post solid organ transplantation.     While mortality from the other leading causes of death post-transplantation (e.g.     cardiovascular disease and infection) is declining, mortality from cancer     post-transplantation is increasing. This is due to both general and transplant-specific risk     factors that combine to increase risk for cancer compared to the general population. However,     there is a shortage of research exploring cancer epidemiology post solid organ     transplantation in the UK. This is essential to guide clinicians and for counselling patients     regarding expectations and outcomes after developing cancer post-transplantation. This is     especially important as the aetiology, pathophysiology and outcomes of cancer     post-transplantation may differ from the general population.      Available data registries in the UK separately contain valuable cancer and     transplant-specific data that can be combined to explore cancer epidemiology     post-transplantation more comprehensively, which can be directly translated into patient     benefit by utilizing transplant-specific data (rather than translating from general     population or non-UK patient demographics). The purpose of this project is to combine     existing data resources to link up the complete patient journey for solid organ transplant     recipients and focus on the entire spectrum of cancer from incidence to mortality.   "
22502|NCT02991092|"     To compare the influence of two different fluid administration strategies on the clinical     efficacy of patients with colorectal carcinoma during the fast-track surgery.   "
22503|NCT02991079|"     This is a randomized, clinical trial aimed at diabetics between 25-70 years (with no     cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain).     It is aimed at assessing the effects of adding an ICT (information and communication     technology) tool, developed for the Smartphone application and group activities of healthy     food and cardio-health rides in support of behavioral and educational recommendations in the     increased physical activity and adaption to the Mediterranean dietary pattern.   "
22515|NCT02989883|"     Esophageal outflow obstruction is characterized by failure to relax the lower esophageal     sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent     stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight     loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the     LES and reduce its pressure to allow esophageal emptying. Therapeutic options include     pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical     myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has     recently been introduced as a minimally invasive treatment, but there have a few studies     regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM     for esophageal outflow obstruction.   "
22504|NCT02991066|"     Although the clinical application of differentiation therapy has made great success in the     treatment of acute promyelocytic leukemia (APL), early fatal bleeding remains an unsolved     problem which accounts for the main reason of induction failure in APL patients. The clinical     manifestation of both serious bleeding and thrombosis illustrate the complexity of the     pathogenesis of coagulopathy in APL. Despite extensive research, the pathogenesis of     coagulopathy in APL is still unclear. Microparticles, 0.11μm in diameter, are small membrane     vesicles released to circulation by blood cells and vascular endothelial cells during     activation or apoptosis. Microparticles (MPs) derived from different cells types all exert     procoagulant activity mediated by phosphatidylserine (PS) and carry some basic substances     derived from their origin cells. Also, the biological activity of microparticles is often     significantly higher than that of the cells they come from. According to these problems and     background knowledge, our project aims to observe the roles of microparticles derived from     APL cells and the procoagulant or profibrinolytic activating factors resided on these     microparticles in the pathogenesis of coagulopathy in APL, and the effects of different     induction therapies, chemotherapeutic drugs or differentiation agents on these microparticles     and their procoagulant or profibrinolytic activating factors. To carry out this study,     microparticles are obtained from patients who undergo different induction therapies at     different time points or from primary bone marrow APL cells which are treated by different     drugs in vitro at different time points, the expressions and activities of five procoagulant     or profibrinolytic activating factors, which are highly expressed in APL cells, PS exposure     and the functional state of these microparticles, will be dynamically monitored. Further     study of the pathogenesis of coagulopathy in APL can provide clues and help for deep     understanding of clinical manifestations, guiding clinical treatment as well as judging     prognosis, and establishing theoretical basis for exploring new treatment.   "
22505|NCT02991053|"     the aim of this study is to compare the effects of Transversus abdominis plane block and     ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the     anesthesia and analgesia contributions during surgery without general anesthesia.   "
22506|NCT02990000|"     Research has shown that mental health care (MHC) providers differ significantly in their     ability to help patients. In addition, providers demonstrate different patterns of     effectiveness across symptom and functioning domains. For example, some providers are     reliably effective in treating numerous patients and problem domains, others are reliably     effective in some domains (e.g., depression, substance abuse) yet appear to struggle in     others (e.g., anxiety, social functioning), and some are reliably ineffective, or even     harmful, across patients and domains. Knowledge of these provider differences is based     largely on patient-reported outcomes collected in routine MHC settings.      Unfortunately, provider performance information is not systematically used to refer or assign     a particular patient to a scientifically based best-matched provider. MHC systems continue to     rely on random or purely pragmatic case assignment and referral, which significantly waters     down the odds of a patient being assigned/referred to a high performing provider in the     patient's area(s) of need, and increases the risk of being assigned/referred to a provider     who may have a track record of ineffectiveness. This research aims to solve the existing     non-patient-centered provider-matching problem.      Specifically, the investigators aim to demonstrate the comparative effectiveness of a     scientifically-based patient-provider match system compared to status quo pragmatic case     assignment. The investigators expect in the scientific match group significantly better     treatment outcomes (e.g., symptoms, quality of life) and higher patient satisfaction with     treatment. The investigators also expect to demonstrate feasibility of implementing a     scientific match process in a community MHC system and broad dissemination of the easily     replicated scientific match technology in diverse health care settings. The importance of     this work for patients cannot be understated. Far too many patients struggle to find the     right provider, which unnecessarily prolongs suffering and promotes health care system     inefficiency. A scientific match system based on routine outcome data uses patient-generated     information to direct this patient to this provider in this setting. In addition, when based     on multidimensional assessment, it allows a wide variety of patient-centered outcomes to be     represented (e.g., symptom domains, functioning domains, quality of life).   "
22507|NCT02989987|"     Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most     effective, culturally sensitive trauma interventions. In the present study the effectiveness     of NET delivered by trained health personnel in a sample of survivors of sexual and gender     based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed.     Structured baseline, 3 and 6 month follow up interviews will be administered to assess the     main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV     and its sequelae has been a major problem.   "
22508|NCT02989974|"     The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop,     administer and evaluate the impact of a comprehensive psychosocial survivorship care program     for individuals diagnosed with lung cancer and their caregivers to improve lung cancer     survivorship and delivery of high-quality lung cancer care. The investigators hypothesize     that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved     quality of life, better symptom control, increased tobacco treatment, and reduced distress     among lung cancer survivors and their caregivers.   "
22509|NCT02989961|"     The purpose of this study is to determine the safety of Resticutis for the treatment of     Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a     placebo comparator.   "
22510|NCT02989948|"     A prospective, single-arm, traditional feasibility study of a physician-modified fenestrated     Cook Zenith TX2 aortic endograft base device in adult patients meeting traditional size     criteria for open surgical treatment of thoracoabdominal aortic aneurysms. Patients meriting     surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be     eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse     events will also be recorded by the Sponsor-Investigator and will be monitored by a locally     appointed Data Monitoring Committee, the Colorado Multiple Institutional Review Board, and     the FDA.   "
22511|NCT02989935|"     This study examines the effect of the ultra long acting beta agonist/corticosteroid     bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles     and ventilation in adults with severe bronchitis or emphysema (COPD).   "
22512|NCT02989922|"     This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210     in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The     primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and     Overall Survival when compare with SOC.   "
22513|NCT02989909|"     Prospective, open-labeled, randomized, controlled, multicenter study at two clinical     investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure     measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).      Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the     low, medium and high IOP ranges shall have the same clinical testing and analysis of results,     with the analysis kept separate from that of the main group.   "
22514|NCT02989896|"     After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in     local vasodilatation, increased local blood flow, and increased skin temperature.Increased     permeability index; Can be used as a reliable tool for evaluating block activity.   "
22530|NCT02990897|"     Researchers now know that treating chronic kidney disease (CKD) in its early stages can     prevent dialysis and reduce heart problems that go along with kidney disease. Computerized     tools may help primary care doctors to diagnose the disease earlier and computer reminders     may help doctors to prescribe the best treatments. In this project the investigators will     test computer reminders in primary care clinics to see if they improve treatment of early     chronic kidney disease and to see if it can promote referral to nephrology.   "
22516|NCT02989870|"     This study involves a course of radiation to up to 5 tumors in the participant's liver     followed by systemic therapy. (Treatment using substances that travel through the     bloodstream, reaching and affecting cells all over the body.) The type of radiation is called     stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the     effects, good and/or bad, of different doses of SBRT given along with the systemic therapies,     sorafenib and bavituximab. The researchers want to see which dose of radiation will work best     in stimulating the immune response and provide local control to the participant's liver. The     usual treatment for hepatocellular carcinoma that is unresectable can be transarterial     therapy, sorafenib alone and/or clinical trial.   "
22517|NCT02989857|"     Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled     study of orally administered AG-120. Subjects, all personnel involved in the evaluation of     subjects' response to treatment (e.g., Investigators, study coordinators, study pharmacists),     and designated Sponsor team members will be blinded to study treatment. Subjects are required     to have a histologically-confirmed diagnosis of IDH1 gene-mutated cholangiocarcinoma that is     not eligible for curative resection, transplantation, or ablative therapies prior to     enrollment.IDH1 mutation testing will be performed at participating investigative sites.     Subjects must have progression of disease and have received at least 1 but not more than 2     prior treatment regimens for advanced disease (nonresectable or metastatic). All subjects     must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy     regimen.   "
22518|NCT02989844|"     This is a multi-center, phase II clinical trial to prevent relapse using interleukin-15     (IL-15) super-agonist complex (ALT-803) maintenance after allogeneic hematopoietic cell     transplantation (alloHCT) in acute myelogenous leukemia (AML) and myelodysplastic syndrome     (MDS).   "
22519|NCT02989831|"     The purpose of this study is to investigate the effects of vibrating insoles on vibration     perception threshold (VPT) and balance of people with diabetic neuropathy.   "
22520|NCT02991027|"     To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton     devices using two light sources.   "
22521|NCT02991014|"     This study aims to compare the impact of listening to frequency-modulated music vs.     non-modulated music (both researcher-selected), and to test whether there are differential     effects on pain and stress perception. Further, these two conditions will be compared to a     third condition, in which participants will be exposed to self-selected non-modulated music.     It is hypothesized that both researcher-selected frequency-modulated music and self-selected     non-modulated music result in stronger decreases in stress and pain compared to     researcher-selected non-modulated music, while it is expected that there will be no     differences in researcher-selected frequency-modulated music and self-selected non-modulated     music. The intervention consists of ten sessions of music listening in the course of three     consecutive weeks.   "
22522|NCT02991001|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Rather than other progressive     disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease     the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively     used in clinical practice, current researches contain small participant without control group     or randomized leading to foreseeable selection bias. The investigators design a randomized,     double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection     in patients with CTS.   "
22523|NCT02990988|"     The goal of this pilot study is to test whether the microbiome is affected by intravenous     iron repletion.   "
22524|NCT02990975|"     Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis     Plane Block supported by ketamine sedation only.   "
22525|NCT02990962|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Rather than other progressive     disease, CTS is characterized by remission and recurrence. Although many conservative     managements of CTS, the effectiveness of these methods is insignificant or only persist for a     short duration including steroid injection. Recently, the ultrasound-guided perineural     injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit.     The investigators design a randomized, double-blind, controlled trail to assess the effect of     ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared     with steroid injection.   "
22526|NCT02990949|"     The aim of this study is to examine the length of ovarian stimulation with the timing of     trigger in an IVF cycle and its potential to impact patient outcomes.   "
22527|NCT02990936|"     The purpose of this study is to determine the impact of tumor growth velocity on the survival     of patients with oropharyngeal squamous cell carcinoma treated by (chemo-)radiotherapy.      Patients with stages I to IV oropharyngeal primary squamous cell carcinoma (OPSCC) elected     for radiotherapy or radiochemotherapy with curative intent will be selected. Tumor volume and     number and size of pathological neck lymph nodes (small diameter > 1 cm) will be assessed on     diagnostic CT-scan (DiCT) and treatment planning CT-scan (RtCT) using the summation of areas     technique. Tumor progression and tumor doubling time will be calculated based on DiCT and     RtCT. Tumor proliferation will be assessed on biopsy specimens by Ki67 immunohistochemistry     and mitotic index. HPV status will be evaluated by PCR and p16 immunohistochemistry.     Ulcerative or exophytic aspect will be noticed. Tumoral kinetics patterns will be correlated     with disease free survival and overall survival of patients with OPSCC. These patterns will     be compared to HPV status and proliferation markers in order to study their clinical     signification [time frame: 5 years] and develop predictive markers of tumor progression for     head and neck cancers.   "
22528|NCT02990923|"     The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve     and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream     infection in hemodialysis patients.   "
22529|NCT02990910|"     A high incidence of respiratory morbidity after adenotonsillectomy is reported in children     with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind,     randomized controlled study to determine the effects of individualized opioid analgesia     compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy     in Children with OSAS.   "
22532|NCT02990871|"     All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain     injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from     emergency department started a rehabilitative treatment during their hospitalization in ICU.     Patients transferred from an external ICU started the rehabilitation in neurorehabilitation     department. Aim of the study is to evaluate if an early rehabilitation, started since the     acute stage of the damage, is able to reduce the decannulation time in this group of     patients.   "
22533|NCT02990858|"     This is an extension study, to provide continued access to PRO 140 to subjects who complete     participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO     140 to form a viable regimen, in the opinion of the treating physician. The patient     population for this trial are treatment-experienced HIV infected patients with CCR5-tropic     virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of     treatment in the PRO140_CD02 study.   "
22534|NCT02990845|"     This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and     leuprolide for subjects being resistant for front-line hormonal therapy for inoperable     locally advanced or metastatic hormonal receptor positive (HR+)/ Human epidermal growth     factor receptor 2 (HER2) negative breast cancer. All the patients will be included in the     final tolerability and preliminary efficacy analysis. The efficacy objectives including PFS,     overall response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR).     Adverse effects will be recorded according to CTCAE v4.0.   "
22535|NCT02990832|"     In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care     as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in     Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were     425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of     life of the patients and attendant negative effects on their families. The 5-year mortality     rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing     LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize     methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by     implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites.     Existing staff with expertise and knowledge in diabetic foot care will assess and treat     patients with moderate and high-risk findings.      In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an     Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be     evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been     demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an     easy-to-use format, thus creating an enhanced wound healing environment while supporting     patient quality of life.      The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of     exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing     under the current standard of care: evaluating key indicators of infection, Infectious     Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits     to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived     benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound     Dressings when combined with the DFCCP.   "
22536|NCT02990819|"     This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen     to allow successful engraftment with alpha/beta T and CD19+ depleted peripheral stem cell     grafts from unrelated or partially matched related donors. There are two conditioning     regimens depending upon patient diagnosis and age.   "
22537|NCT02990806|"     The purpose of this study is to demonstrate similarity of NI-071 (proposed biosimilar to     infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in patients     with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).   "
22538|NCT02990793|"     The purpose of this study is to evaluate the safety and efficacy of individualized,     Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Persistent Post-Concussive     Symptoms (PPCS) following Traumatic Brain Injury (TBI).   "
22539|NCT02990780|"     This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of     induction chemotherapy followed by accelerated hypofractionated vs. conventionally     fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.   "
22540|NCT02990767|"     The aims of this study are to develop algorithms based on a combination of maternal factors,     uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early     Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.   "
22541|NCT02990754|"     Fearless Physical Activity are fun, physical literacy events where people with congenital     heart disease (CHD) and sport/recreation leaders can do community-based sport/recreation     opportunities without fear (i.e., appropriate for their health). Ontarians with CHD are a     large and rapidly growing population;1% of children are born with CHD, adding 1,440 new     children/year to the 113,900 Ontarians of all ages who are living with CHD. 'Fearless' will     target CHD children, youth or adults, while encouraging family-based participation. During     each season, the investigators will offer a one-day event for each age group (children,     youth, adults) in each region of Ontario (4 seasons x 3 age groups x 4 regions = 48 events).     Event activities will be hosted by community partners, such as the MLSE Launch Pad (Toronto)     or the YMCA/YWCA of the National Capital Region (Ottawa), so that they are sustainable beyond     this project. Activities will be chosen based on opportunities available in local communities     at little to no cost (e.g., use of local trails and parks). Event leaders and participants     will be educated about physical literacy and screening tasks will be used to identify those     needing significant or specialized physical literacy support. People with CHD lead mostly     sedentary lives. They are much less active than their friends and colleagues, even when their     heart disease is mild, and inactivity can contribute to a higher risk for heart attacks,     stroke, obesity, and depression. Uncertainty about physical activity, even though it is     recommended (American Heart Association, May 2014), is an important barrier to the physical     and mental health benefits of physical activity. How much is too much? and Will it be too     much for my heart? are top-of-mind. Fearless Physical Activity will provide children,     youth and adults living with CHD with new physical activity experiences and opportunities to     enhance their physical literacy so they are better able to be active for life.   "
22556|NCT02990559|"     This pilot study is designed to investigate (1) whether getting iron treatment affects iron     in the brain and (2) how getting iron treatment affects brain functions when it is performing     specific cognitive tasks. By cognitive tasks, it means tasks that involve perceiving,     representing, or assessing things. The specific cognitive tasks used here will involve tests     of memory and processing speed.   "
22557|NCT02990546|"     The aim of this study is to investigate the role of oral midodrine in the recovery of septic     shock. The investigators hypothesize that the oral drug can reduce central line days and ICU     length of stay.   "
22558|NCT02990533|"     The goal of this study is to collect preliminary data on the efficacy of interventions to     enhance recovery from hospitalization in community dwelling older adults.   "
22559|NCT02990520|"     The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at     admission to the hospital in older adults.   "
22542|NCT02990741|"     1. Study name:A randomized clinical trial on atrial fibrillation screening by using an          automated electrocardiogram system in an elderly Chinese population        2. Rationale: Failure in the diagnosis and management of atrial fibrillation leads to high          incidence of stroke and high mortality and disability. It is therefore imperative to          diagnose and manage atrial fibrillation in a timely and effective fashion to prevent the          complications of atrial fibrillation.        3. Objective:The primary objective is to investigate whether more frequent ECG recordings          and analyses with this automated ECG system (4 times/year) would significantly improve          the detection of atrial fibrillation compared to a single annual ECG screen.The          secondary objective is to explore whether even more frequent ECG recordings and analyses          (8 times/year) would further improve the detection of atrial fibrillation.        4. Study design: The present study is designed as a randomized controlled trial of parallel          group (two).        5. Study population: Men and women aged at least 65 years (n=7000) meet the          inclusion/exclusion criteria.        6. Randomization and treatment: Eligible subjects will be randomized in a 1:1 ratio into          the usual and intensive screening groups with 3500 patients in each group, and within          the intensive screening group in a 3:1 ratio into the intensive and more intensive          subgroups with 2625 and 875 patients, respectively.        7. Follow up: 1)Usual screening group: ECG recordings at baseline plus at 1 year of          follow-up; two ECG recordings in total. 2)Intensive screening subgroup: ECG recordings          at baseline plus quarterly during follow-up, at months 3, 6, 9 and 12; 5 ECG recordings          in total. 3)More intensive screening subgroup: ECG recordings at baseline plus weekly          during the first month of follow-up and quarterly afterwards, at weeks 1, 2, 3 and 4 and          months 3, 6, 9 and 12; 9 ECG recordings in total.        8. Sample size estimation: The number of required subject for the whole trial is 7000.        9. Timeline: Start of subjects enrollment : December 2016; End of subjects enrollment :          June 2017; End of study : June 2018       10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin          Hospital, Shanghai, China.   "
22543|NCT02990728|"     Primary objective To discover the efficacies of levonorgestrel-containing intrauterine device     (LNG-IUS, Mirena®), with or without metformin, as fertility-preserving treatment for grade 1     endometrioid adenocarcinoma of endometrium, cT1aN0M0 with presumed no myometrial invasion on     image study (MRI preferred).      Secondary objectives        1. To discover the morphological and molecular change in the endometrium tumor before and          after treatment        2. To discover the effectiveness of adding oral progestin to subjects who show no good          response to assigned        3. To compare (1) the systemic effects, including body weight change, neuropsychiatric          alternation, GI disturbance, skin disorder, change in serum metabolic and hepatic          markers between the two study patient groups; (2) The rate of long-term success defined          as (a) sustained remission of >= 12 months starts from the histologic documentation of          complete remission (b) rate of pregnancy and (c) alive baby delivery, based on          time-to-event analysis.        4. Molecular markers and their expression before, during and after treatment, including          progesterone B receptor, progesterone A receptor, estrogen receptor, Ki67, PTEN and its          related markers, Bcl2 and its related markers and other developing markers. This is to          discover prediction markers to medical treatment.   "
22544|NCT02990715|"     The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in     providing structural information on colonic polypoid lesions and masses, as an adjacent tool     to FIT.   "
22545|NCT02990702|"     The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between     the needle and the ultrasound beam. Retroclavicular approach has already been proven     effective and safe in the past. The general objective is to provide a formal comparison     between the retroclavicular approach and coracoid infraclavicular approach for brachial     plexus anaesthesia. This study should represent the differences between the two techniques.   "
22546|NCT02990689|"     The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL     for far, near and intermediate vision.   "
22547|NCT02990676|"     Cognitive impairments, especially deficits of executive function, have been well documented     as a core and early feature in Huntington's disease (HD). Cognitive impairments can be     considerably burdensome and devastating for people and families affected by HD. Computerised     cognitive training interventions that focus on improving executive function present a     potentially exciting non-pharmacological treatment option. Novel work conducted in mouse     models of HD, has demonstrated that cognitive training, administered from an early stage in     the disease, can improve motor performance at an older age, even in the absence of further     training in the intervening time. This represents proof of principle in an animal model of HD     that cognitive training can improve HD disease symptoms.      Improvements associated with executive function training have also been reported in a     clinical setting in a variety of neurodegenerative diseases. For example, cognitive training,     can improve executive function as people age, and training specifically focused on tasks of     executive function has been shown to improve both cognitive and motor outcomes in     neurodegenerative diseases such as Parkinson's disease (PD) and Alzheimer's disease (AD).     Therefore, this study is a feasibility study which aims to establish proof of principle for     using computerised cognitive training in people with HD. The investigators propose to     determine the feasibility, acceptability and gather preliminary evidence of the effectiveness     of a cognitive training intervention programme, targeted for people with HD. The     investigators will also aim to investigate the most appropriate outcome measures to use in     this study and gather feedback on the cognitive training intervention. The investigators will     also establish proof of concept via the study of brain structure and function, using MRI     scanning techniques.      The computerised cognitive training software and the associated outcome measures will be     investigated, taking into account the views of people and families who are affected by HD. A     randomised feasibility study of computerised cognitive training for people with HD will then     be conducted. Participants who are randomised to the cognitive training intervention group     will be asked to complete a cognitive training intervention utilising HAPPYneuron software.     Participants in the intervention group will be asked to complete the cognitive training     programme for a minimum of 30 minutes, 3 times a week for the 12 week study duration.     Participants in the control group will not receive any cognitive training and will be asked     to continue as normal, however they will have home visits to control for the confounding     effect of social interaction. Additional monitoring and prompting for the intervention group,     will be conducted via email, text or telephone reminders (as preferred by the participant)     and home visits. The motor and cognitive function of participants will be assessed at the     beginning and end of the study, using a range of motor and cognitive assessments. Additional     cognitive measurements will be recorded as part of the HAPPYneuron programme throughout the     cognitive training intervention, such as accuracy and response time measures of particular     computer games. MRI scans (optional) will be conducted at the beginning and end of the study     to identify any structural changes in the brain that may be associated with the cognitive     training intervention. As part of the feasibility and acceptability assessment, participants,     family members and carers will be invited to complete a semi-structured interview at the end     of the study, if consent is obtained, focusing on using this type of software as a home based     therapeutic intervention.   "
22548|NCT02990663|"     High blood pressure is common and its presence increases the risk of cardiovascular mortality     and morbidity (most notably stroke, myocardial infarction, and congestive heart failure).     Given blood pressure is normally higher during the day than it is overnight, blood pressure     lowering medications are traditionally taken in the morning. However a randomized trial of     2156 Spanish hypertension patients published in 2010 (MAPEC), suggests a large (61%)     reduction in mortality and cardiovascular morbidity if such medications are instead taken at     bedtime. This degree of benefit far exceeds other established methods of cardiovascular risk     reduction - and such a surprisingly large effect requires independent confirmation for     practice to change. BedMed is a pragmatic randomized controlled trial (target N = 8750)     facilitated by over 300 Canadian family physician members of the Pragmatic Trials     Collaborative. During the conduct of this trial consenting hypertensive primary care     patients, already established on one or more antihypertensive medications, will be randomized     to either morning or bedtime antihypertensive use. Patient oriented trial outcomes evaluating     both potential benefits and harms will be drawn largely from administrative health data that     is routinely collected on all residents of Canada's publicly funded health care system. This     trial is event driven (ending upon the occurrence of 406 primary outcome events) and expected     to run over a period of roughly 3 years.   "
22549|NCT02990650|"     Using a randomized controlled research design, compare walking outcomes resulting from gait     and balance training with standard physical therapist interaction versus training with the     addition of a KineAssist® robotic system that provides for safety and freedom of movement.   "
22550|NCT02990637|"     The purpose of this study is to investigate the effects of daily supplementation of OLECOL     for a period of 8 weeks on cardiovascular risk markers.   "
22551|NCT02990624|"     Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological     diseases, including psoriasis. The systemic effects of UV phototherapy are still not well     studied. There are several factors that may affect patient's cardiovascular (CV) risk during     UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be     frequently associated with psoriasis. In this study the investigators aim at studying the     effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with     psoriasis with or without atherosclerosis.   "
22552|NCT02990611|"     Real-Life Efficacy and Safety of Nivolumab monotherapy or in combination with Ipilimumab in     Patients with Advanced (Unresectable or Metastatic) Melanoma   "
22553|NCT02990598|"     To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a     single dose to lactating women   "
22554|NCT02990585|"     This study will be a comparative design between 2 groups of subjects attending classes on     back education in an urban setting. Participants will be randomized to either an individual     one-on-one back school session or to the 8 group sessions.   "
22560|NCT02990507|"     An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates     arm and leg ergometers in conjunction with a virtual reality interface. The purpose of this     study is to examine participant perspectives regarding the virtual interface and exercise     device combination with regard to usability, comfort, safety, rating of perceived exertion,     and enjoyment.   "
22561|NCT02990494|"     Making healthy food choices requires sacrificing immediate pleasures of consuming high     calorie foods in order to achieve long-term health goals. Two strategies to encourage such     future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods,     and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel     behavioral weight loss (BWL) interventions will be developed based on these strategies     (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their     feasibility and efficacy in changing food choice decision-making, reducing food cravings, and     ultimate weight loss.   "
22562|NCT02990481|"     1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of          TRK-950 as single agent        2. To establish the dose of TRK-950 recommended for future phase 2 studies   "
22563|NCT02990468|"     This is a Phase 1a-b study of newly diagnosed patients with biopsy-proven head and neck     cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment     with cisplatin. BMX-001 added to radiation therapy and cisplatin is expected to reduce     radiation-induced mucositis and xerostomia and also has the potential to benefit the survival     of head and neck cancer patients. In Phase 1a, safety and tolerability of BMX-001 will be     assessed using a Continual Reassessment Method (CRM) and a maximum tolerated dose (MTD) will     be determined. BMX-001 will be given subcutaneously first with a loading dose zero to four     days prior to the start of chemoradiation and followed by twice a week doses at one-half of     the loading dose for the duration of radiation therapy plus two weeks. In Phase 1b both     safety and efficacy of BMX-001 will be evaluated. Impact on mucositis and xerostomia will     also be assessed. A maximum of 48 patients will be enrolled to the MTD dose determined in     Phase 1a to confirm the MTD. The investigators hypothesize that BMX-001 when added to     standard radiation therapy and cisplatin will be safe at pharmacologically relevant doses in     patients with newly diagnosed head and neck cancer. The investigators also hypothesize that     in Phase 1b of this study the addition of BMX-001 will reduce the severity of     radiation-induced mucositis and xerostomia in patients receiving head and neck radiation     therapy.   "
22564|NCT02990455|"     The proposed research will investigate whether smokers with vs. without current alcohol use     disorder (AUD) respond to reduced nicotine cigarettes by increasing their alcohol consumption     or smoke exposure, thereby diminishing the hypothesized public health benefit of these new     products.   "
22565|NCT02990442|"     Forensic patients will undergo 30 rTMS treatments, once per day each business day using a 1Hz     frequency at the right dorso-lateral pre frontal cortex, located using modified BEAM F3.     Patients will be assessed before and after the study with a battery of assessments and using     2 computer tasks: a ball passing task, and the Point Subtraction Aggression Paradigm (PSAP).     The investigators will also monitor and record aggressive incidents that take place on the     unit.   "
22566|NCT02990429|"     Perioperative hypothermia is a common problem. It has been defined as a core temperature     below 36ºC. The reasons why patient undergoing gynecologic laparoscopic surgery has     perioperative hypothermia because the reduced metabolic heat production, redistribution of     heat from the core to the periphery and impaired thermoregulation (due to anesthetics), use     of cool carbon dioxide gas insufflations and surgical irrigation solution, as well as heat     loss due to the cool environment. This perioperative problem has been linked to adverse     patient outcomes such as myocardial ischemia as hypothermia increases plasma catecholamine,     surgical site infection as hypothermia diminishes wound tissue O2 tension and coagulopathy as     hypothermia impairs platelet function.      It claims that perioperative heat loss occurs by radiation (60%), convection (25%) and     evaporation (10%). This is caused by the difference between peripheral body and ambient     temperature, air circulation around the body and vasodilatation.      In daily practice, most anesthesia personnel warm patient peri-operatively by using force air     warmer and intravenous fluid warmer.      This study aimed to compare the difference of core and room temperature in patients     undergoing gynecologic laparoscopic surgery by using forced air and intravenous fluid warmer   "
22567|NCT02990416|"     This study evaluates the effectiveness of adding a single four-day treatment of the fusion     protein A-dmDT390-bisFv(UCHT1) — plus single palliative tumor radiation — with standard of     care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results     will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.   "
22568|NCT02990403|"     In this clinical cohort study, the investigators are going to observe the efficacy of     anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a     prospective randomized controlled trial.   "
22569|NCT02990390|"     RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune     disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections.     However, the underlying causes remain undetermined in up to 50% of cases. In this clinical     cohort study, we intended to get an epidemiological evidence for patients with recurrent     spontaneous abortion associated with thrombophilla.   "
22570|NCT02990377|"     In recent years in the U.S., problems associated with opioid prescriptions, including     non-medical use and overdose, increased to historically unprecedented levels and represent a     public health crisis. Emergency departments (EDs) play an important role in opioid     prescribing, particularly to individuals at high risk for adverse opioid-related outcomes.     The purpose of this study is to determine whether a new mobile health (mhealth) intervention     can assist people in the safe use of opioid analgesic (OA) medications after leaving the     emergency department (ED).      The specific aims of this project are to: (1) adapt and enhance an existing motivational     intervention to decrease non-medical opioid use after an ED visit by optimizing intervention     intensity and duration through reinforcement learning (RL); (2) examine the impact of an     RL-supported intervention on non-medical opioid use level during the six months post-ED     visit; and (3) examine the impact of the RL intervention on the opioid-related behaviors and     adverse outcomes of driving after opioid use, overdose risk behaviors, and subsequent     opioid-related ED visits. The secondary aims of this project are to: (SA1) examine whether     baseline level of non-medical opioid use moderates the effects of the intervention; and (SA2)     understand barriers and facilitators of implementation of the intervention based on     qualitative interviews with ED patients.   "
29432|NCT02900417|"     The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive     sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the     composition of gut microbiota before and after the therapy of sitagliptin.   "
22571|NCT02990364|"     Circumcision is a commonly performed procedure on newborn males. Clear recommendations and/or     guidelines for pain control during the procedure do not exist. The purpose of this research     is to compare various forms of analgesia to evaluate which is the more effective for pain     reduction. The investigators hope that this study can provide definitive guidelines on the     best form of analgesia to use during circumcision. It is important that we perform this study     to ensure that in the future newborns' pain during circumcision is effectively managed.   "
22572|NCT02990351|"     This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver     Transplantation in patients with HCC.   "
22573|NCT02990338|"     Primary Objective:      To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose     dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to     pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and     refractory multiple myeloma (MM).      Secondary Objectives:        -  To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group          (IMWG) criteria in each arm.        -  To compare the Overall Survival (OS) between the two arms.        -  To evaluate the Time To Progression (TTP) in each arm.        -  To evaluate the Progression Free Survival (PFS) in high risk cytogenetic population in          each arm.        -  To evaluate the Duration of Response (DOR) in each arm.        -  To evaluate the safety in both treatment arms.        -  To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.        -  To evaluate the immunogenicity of isatuximab.        -  To assess disease-specific and generic health-related quality of life (HRQL), disease          and treatment-related symptoms, health state utility, and health status.   "
22574|NCT02990325|"     The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological     sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,     compartmental pharmacokinetics, and pharmacodynamics.   "
22575|NCT02990312|"     The purpose of this proof of concept, pilot study is to determine whether the unique     combination of the human immunodeficiency virus (HIV) co-receptor antagonist, Maraviroc, and     the mammalian target of rapamycin (mTOR) inhibitor, Sirolimus, in HIV-infected kidney     transplant recipients has an impact on chemokine receptor 5 (CCR5) density, the     HIV-reservoir, or rejection of the transplanted kidney. 15 HIV-infected kidney transplant     recipients will be recruited and their immunosuppressant regimen will be changed to include     an mTOR inhibitor (such as Sirolimus) unless they are already on one. In addition, Maraviroc     will be added to their HIV regimen, unless they are already on Maraviroc. Blood will be taken     to measure markers of the HIV reservoir, their CCR5 density and expression, and immune     activation.   "
22576|NCT02990299|"     The purpose of this research study is to determine the benefit and cost of including health     coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and     videoconferencing in diabetes management support services for African-Americans and Latinos     with uncontrolled Type 2 Diabetes.   "
22577|NCT02990286|"     The purpose of the study is to evaluate the efficacy on lung function 6 months after one     course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one     course of placebo and 6 months of MMF treatment in a broad range of patients with     Interstitial Lung Diseases (ILD) non-responders to a first line immunosuppressive treatment.   "
22578|NCT02990273|"     Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting     in rebalanced homeostasis. However, conventional blood tests (platelets/ INR levels) that     are performed prior to invasive procedures do not accurately reflect the coagulation changes     that occur in cirrhotics, resulting in unnecessary transfusion of blood products.     Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in     surgery (including liver transplant) to help guide blood product transfusion in the operating     room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide     blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The     investigators will evaluate to see if there is a decrease in prophylactic blood transfusions     prior to endoscopy when using TEG.   "
22579|NCT02990260|"     The aim of the study is to evaluate the effect of the consumption of a food supplement (live     saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.   "
22580|NCT02990247|"     Asthma exacerbations account for a significant morbidity and disproportionate health care     costs. However, there is no currently available biomarker or lung function parameter that can     accurately predict the risk of future exacerbations. The current work aims at evaluating the     resting ventilatory flow by applying a new technique called anharmonic morphological analysis     of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able     to detect an increased risk of asthma exacerbations.   "
22581|NCT02990234|"     The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular     Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient     outcomes in the short, mid and long term, both clinically and radiographically, compared to     those without capsular repair. The objective of this clinical trial is to evaluate the     clinical efficacy with regards to pain, range of motion and return to work and activities of     daily living. Secondary objective is to evaluate radiographic characteristics between both     groups.   "
22582|NCT02990221|"     The main objective of this study is to compare the effectiveness of ingenol mebutate gel (150     mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or     scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of     each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the     treatment of actinic keratosis and their field cancerization.      Study details:      This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II,     located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the     inclusion criteria will be enrolled in the study by the investigators in the three different     centers mentioned above.      The investigators will assess the effect of treatment by confocal microscopy and digital     dermoscopy. The investigator will acquire images of selected areas of the face and scalp     before and after treatment. Data will be collected and analyzed by the coordinating centre.      Procedure for the study:      Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150     micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited;     evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The     measurements will be carried out at time 0, after 1 month and 6 months. The investigator must     fill out a form for each subject at the beginning (day 0), after 1 month and at the end of     the study (after 6 months). The subject must complete a questionnaire at the beginning (day     0), after 1 month and at the last follow-up visit (after 6 months).      Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the     percentage reduction in actinic keratoses and the damage of the cancerous area in the two     selected areas treated with ingenol mebutate gel or cryotherapy, respectively.      Adverse / side events will be collected at each visit by the investigator and will be     contained in another form.   "
22583|NCT02990208|"     The study investigated the effect of diaphragmatic breathing as an additional coping strategy     during Virtual Reality Exposure Therapy in patients with aviophobia. The authors assumed that     diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the     VRET and to an enhanced treatment outcome   "
22584|NCT02990195|"     Multicentre prospective human experimental study to determine the effect of chyme reinfusion     in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)   "
22585|NCT02990182|"     In a previous study by the researchers' group, the researchers' investigate the duration of     yellow fever post-vaccination immunity in vaccinated children between 9 and 23 months of age.     However, in this study, samples of children in the pre-vaccine period, also known as     unvaccinated children samples (NV) have not been investigated. It is believed that to seek     evidence about the immune status in the medium and long term after vaccination against yellow     fever is necessary to investigate paired samples of children not vaccinated (NV), with     re-evaluation 30-45 days after primary vaccination. The proposed study is to consolidate     aspects of humoral (neutralizing antibodies) and cellular (phenotypic and functional     parameters of T cells and memory B) by means of complementary longitudinal investigation     children, 9-23 months old, unvaccinated (NV) and 30-45 days after primary vaccination.   "
22586|NCT02990169|"     Prospective, open-labeled, randomized, controlled, multicenter study at two clinical     investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure     measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).     Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based     on standard of care vision examination at the clinical investigation sites. All subjects will     undergo a standard ophthalmic exam and informed consent. IOP will be measured using a     Goldmann tonometer armature with both the standard flat GAT prism and the modified curved     CATS prism alternately inserted. The only additional measurement is central corneal thickness     (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT     prism and is currently standard of care.   "
22587|NCT02990156|"     The scope of this trial is the collection and analysis of effectiveness and safety endpoints,     related to the use of the MicroPort NeuroTech Coil Embolization System in the treatment of     intracranial aneurysms.   "
22588|NCT02990143|"     The purpose of this study is to investigate whether placing Ologen over the posterior plate     of the Ahmed glaucoma drainage device during initial implantation will allow the formation of     a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the     postoperative period.   "
22589|NCT02990130|"     This proposal aims to characterize biochemical and physiologic factors that contribute to     changes in patient fitness and body composition during hematopoietic stem cell     transplantation (HCT) for hematologic malignancies. The study group will consist of 60     patients with hematologic malignancies treated with HCT. Measurements of patient fitness,     body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days     (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA,     additional visits (not exceeding 6 total) may be requested periodically for up to 2 years     after HCT.   "
22590|NCT02990117|"     The introduction of inhaled medication as the primary treatment for asthma has led to     substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still     common and represents a considerable burden to patients and society [3, 4]. An important     reason for poor asthma control and consequently, increased healthcare expenditure is     suboptimal adherence to the prescribed regimen [5-7].      Real-world market research study in hospitals across China reported that physicians perceived     that only 23% of patients were fully compliant with their medication regime (77%     non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal     document]. The physician reported rate of full adherence was lower than the patient-reported     rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of     physicians) when treating an asthma.[8]      However      There is some evidence on the drivers of patient behaviour around low adherence but more     depth research is needed      There is little evidence on variation of determinants of asthma inhaled treatment across     different age of group      Our research aims to address above data gap Mean while this research can guide the     development of new module on Red Scarf patient education program.   "
22591|NCT02990104|"     The purpose of this study is to describe the incidence, clinic characteristics, biological     and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.   "
22592|NCT02990091|"     This is a Phase 2 clinical trial designed to obtain data on relationships between potentially     therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular     derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after     TBI.   "
22593|NCT02990078|"     The investigators will longitudinally measure cerebrovascular reactivity (CVR) by functional     near-infrared spectroscopy (fNIRS) in acute (≤3 days from injury), subacute, and chronic     phases after TBI as a biomarker of TCVI as compared to healthy controls. CVR will be measured     by fNIRS response to hypercapnia. The investigators hypothesize that CVR will be decreased     after TBI and that these decreases will correlate with clinical outcomes. Furthermore, the     investigators predict that administration of a vasodilatory medication (sildenafil) will     augment CVR after TBI.   "
22594|NCT02990065|"     The purposes of the study are:        -  To strictly ensure the appropriate level of protein and caloric provision in critical          illness, according to the latest literature recommendation;        -  To determine if an association exists between protein intake and nitrogen balance in the          context of a nutrition with appropriate protein provision based on the latest literature          recommendations, rather than in a standard diet with a caloric target weight-based.          Creatinine clearance will also be evaluated to determine if there is any harmful effect          to the kidney secondary to an elevated BUN.        -  To determine if there is a difference in ICU mortality rate between the current          nutrition standard and a hyperproteic nutrition protocol.   "
22595|NCT02990052|"     A prospective, randomized controlled single-center trial with 80 patients aged 50 years and     above to compare the functional and radiological results of conservative treatment and volar     fixed-angle plating in the management of distal radius fracture   "
22597|NCT02990026|"     Specialty mental health probation for offenders with severe mental illness has been widely     disseminated; however, randomized studies are needed to determine its effectiveness. The     purpose of the study is to test the feasibility and efficacy of specialty mental health     probation (SMHP) for probationers with mental illness in North Carolina. 320 adult     probationers with mental illness in will be randomly assigned to specialty mental health     probation (experimental condition) or usual probation (control condition). Probationers     assigned to the experimental condition will be supervised by specialty mental health     probation officers, who will have reduced caseloads and advanced training in mental health     and other topics. Probationers assigned to the control condition will receive standard     probation. Criminal justice and mental health outcomes will be examined.   "
22598|NCT02990013|"     Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome     on human skin      Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol     against AvenovaTM as a sterile skin agent   "
22599|NCT02989818|"     The aim of this multi-center study is to prospectively document the clinical utility of ESD.   "
22600|NCT02989805|"     This study will compare the effectiveness of professional and peer care managers in improving     linkage to and engagement in outpatient care after an emergency department (ED) discharge, as     well as the mechanisms by which engagement occurs. The study will use a multi-site randomized     trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site     will have one professional care manager (social worker or nurse) and one peer specialist care     manager. Eligible subjects at each site will be randomized to a one-year treatment engagement     intervention, the Coordination, Access, Referral and Evaluation (CARE) Program with either a     peer or professional care manager, resulting in a total of 1000 participants across sites.     The CARE program will focus on shared decision-making between care managers and patients, and     combines the traditional medical model of care management with a recovery-based approach.     Follow-up interviews at baseline, 6 months and 12 months will assess outpatient treatment     engagement after discharge from the ED, changes in mental health and clinical outcomes, and     changes in attitudinal and logistical barriers to obtaining services.   "
22601|NCT02989792|"     Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling     for genotyping purposes. In addition they will compete the personality questionnaires they     had completed in the former trial.   "
22602|NCT02989779|"     Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind     placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and Modified     Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI before the     trial begins. Patients receive either one week of the drug or one week of placebo and perform     the same tasks and assessments. Then patients receive another week of the alternate pill,     followed by another round of tasks during MRI and assessments.   "
22603|NCT02989766|"     This intervention would be a series of self-help-style educational and motivational activity     sheets for patients to complete independently. This will be a randomized clinical control     trial.      Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects     in the intervention arm will complete 3 activity sheets prenatally during their wait time at     the clinic. The first worksheet can be completed the day of recruitment after consent is     signed.      Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration     of breast feeding.   "
22604|NCT02989753|"     This study is designed as a pilot study in order to estimate the effect of VAL070-A and     VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these     data are still unknown for these products and in this specific population. Collected data     will provide more reliable information which may be used to plan a subsequent larger main     study.   "
22605|NCT02989740|"     Title:      Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic     Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes     Mellitus Patients COMBINE (OCT-FFR) Prospective Register      To study the natural evolution of patients with at least one intermediate angiographic but     non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no     TCFA as detected by OCT imaging and to compare these two groups of patients with each other     as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on     future MACE.   "
22606|NCT02989727|"     The purpose of this study is to determine if patients with melancholic bipolar II depression     are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.     To do this, the investigators will re-analyze a previous clinical trial that evaluated     lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).   "
22607|NCT02989714|"     This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High     Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days     apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in     combination with Nivolumab.      Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the     anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate     that the combination of the two therapies would result in an increase in the overall response     rate, complete response rate, and improved survival outcomes compared to either of the     individual therapies.   "
22608|NCT02989701|"     Sickle cell disease (SCD) is one of the most common genetic diseases in the world. In North     America, an estimated 2600 babies are born with SCD each year1, and approximately 70,000 to     100,000 individuals of all ages are affected in the United States2. The clinical     manifestations of SCD include acute events, such as recurrent debilitating painful crises, as     well as life-threatening pulmonary, cardiovascular, renal, and neurologic complications. The     only established curative treatment for SCD patients is allogeneic hematopoietic stem cell     transplant (HSCT). Unfortunately, access to this intervention is limited by availability of     suitable matched donors, and HSCT is associated with significant morbidity and mortality. For     patients who cannot undergo HSCT, treatment of SCD has been limited to one FDA-approved     medication, hydroxyurea, and supportive symptomatic care. After decades with very few novel     therapeutic options for SCD patients, autologous cell-based genetic therapies, including     lentiviral-based gene therapy as well as gene editing, now offer the possibility of     innovative curative approaches for patients lacking a matched donor for hematopoietic stem     cell transplantation.      Gene therapy for sickle cell disease is increasingly promising, and there are currently open     clinical trials at several centers that employ a gene addition strategy.      Options for autologous HSC collection include bone marrow harvest or peripheral blood HSC     mobilization. Bone marrow (BM) harvest is an invasive procedure requiring anesthesia, which     is associated with sickle cell-related morbidities, and may not achieve goal CD34+ cell dose,     necessitating repeated procedures scheduled over multiple months. In most gene therapy     trials, HSCs are obtained through peripheral collection after mobilization with granulocyte     colony-stimulating factor (G-CSF) followed by peripheral blood (PB) apheresis. However, this     approach is contraindicated in SCD because G-CSF has been reported to cause severe adverse     effects in sickle cell patients. Even with doses sometimes smaller than standard, G-CSF has     been shown to result in vaso-occlusive crises, severe acute chest syndrome, and in one     report, massive splenomegaly and death. Alternative options for mobilization are needed.      Plerixafor has been compared to G-CSF in a sickle cell mouse model, and results showed     effective mobilization of HSC subsets, without neutrophil or endothelial activation, and with     lower total WBC and neutrophil counts compared to G-CSF-treated mice. Plerixafor use has not     yet been documented in sickle cell patients. One other trial is currently open to test     plerixafor in SCD patients (NCT02193191) but no results have yet been reported. Based on     pre-clinical data, the mechanism of action of plerixafor, as well strategies the investigator     will employ to mitigate risk, the investigator anticipates that it will be well-tolerated in     the SCD patient population.   "
22609|NCT02989688|"     Patients with kidney, or renal, failure require life-saving treatment with regular dialysis.     Dialysis is a form of treatment that simulates some kidney functions; to remove harmful waste     products and extra water from the blood. Almost one-third of people with kidney failure also     have diabetes, as diabetes is one of the leading causes of kidney disease in the United     Kingdom, usually due to poor blood sugar control over a long period of time. Malnutrition is     common in patients needing dialysis due to kidney failure causing fatigue, taste changes and     a build up of waste products, which can reduce appetite. Treatment of malnutrition involves     increasing both the energy and protein intake from food and drinks, and milk-drink style     specialist nutrition drinks are often given to dialysis patients due to their specific     dietary needs. These nutrition drinks can increase blood sugar levels and optimal control for     diabetes may be difficult. This research study aims to measure the blood sugar response to a     slow-release sugar nutrition drink specifically designed for dialysis patients, which may     result in a lower blood sugar level, compared to standard nutrition drinks, consumed during a     dialysis session. 28 patients with diabetes and having regular dialysis treatment will enrol     in the study. Patients will be asked to drink 1 of 3 different nutrition drinks, once a week     for 3 weeks during their regular dialysis treatment. Blood sugar levels will be measured from     the blood samples taken from the patient's circulation directly before it enters the dialysis     machine over 3 hours and the maximum blood sugar reading and total blood sugar response will     be measured. Differences between the 3 drinks will be tested statistically. The results will     help to advise patients with diabetes and kidney failure on the most suitable type of     nutrition drink to consume during dialysis.   "
22610|NCT02989675|"     The purpose of this study is to evaluate the impact of dextrose administration in severely     sick children admitted to hospital with low-glycaemia.      The problem: Mortality in children remains high in sub-Saharan African hospitals. While     antimalarial drugs, antibiotics and other definitive treatments are well understood, the role     of emergency care with supportive therapies such as maintaining normal glucose and     electrolyte balances, has been given limited attention. Hypoglycaemia is common in children     admitted to hospital in low-income settings. The current definition of hypoglycaemia is a     blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a     mortality rate of up to 42%. An increased mortality has also been reported among acutely ill     children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason     for increased mortality rates is not fully understood.      Study objective: To determine the impact on mortality of a raised treatment cut-off level for     paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.      Methodology: Severely ill children admitted to Queen Elizabeth Central Hospital in Blantyre,     Malawi with low-glycaemia (2.5-5.0mmol/l) will be randomised into intervention or control     groups. The intervention group will be treated with an intravenous bolus of 10% dextrose     5ml/kg followed by a dextrose infusion in addition to standard care while the control group     will receive standard care only. Children will be followed until discharge from hospital or     death. Primary end-point is in-hospital mortality.   "
22611|NCT02989662|"     In alcohol use disorder (AUD) and matched healthy control (HC) men and women, the proposed     research examines the effects of MIFE, with demonstrated preclinical effects on     drinking-related behaviors, compared with placebo on a breadth of alcohol-related measures.     All subjects will be randomized to daily MIFE or placebo. Before and during medication, AUD     and HC subjects undergo fMRI scanning measuring resting-state functional connectivity and     alcohol cue-induced brain activation focused on brain reward and stress pathways. All     subjects are admitted to the Clinical Research Unit; AUD subjects undergo supervised alcohol     withdrawal with daily measurements of alcohol craving and symptom severity. Using validated     human laboratory procedures in AUD subjects, this study will examine the effects of stress on     motivation to drink and alcohol sensitivity/reward as a function of GR antagonism.   "
22612|NCT02989649|"     The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations     (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or     alogliptin FDCs, in standard clinical practice.   "
22613|NCT02989636|"     This phase I trial studies the side effects of nivolumab with or without stereotactic     radiosurgery in treating patients with chordoma that has come back or spread from where it     started to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere     with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a     specialized radiation therapy that delivers a single, high dose of radiation directly to the     tumor and may cause less damage to normal tissue. It is not yet known whether giving     nivolumab with or without stereotactic radiosurgery may work better in treating patients with     chordoma.   "
22614|NCT02989623|"     This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography     (PET) works in detecting prostate cancer in patients with persistently elevated prostate     specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound     made of a radioactive agent attached to a molecule that looks like a hormone that binds to     cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able     to see tumors at an earlier stage than the standard of care.   "
22615|NCT02989610|"     The purpose of this post market study is to support the chronic clinical performance of the     Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads,     extensions and related system components.   "
22616|NCT02989597|"     Methadone has several advantages over standard narcotic medications, especially when     considering use after a typically painful surgery such as lumbar fusion. Methadone is low     cost, has a long half-life, has a convenient dosing schedule, has excellent oral     bioavailability, and demonstrates slow onset to withdrawal. The literature comparing     methadone to more commonly used post-operative narcotics demonstrates that it manages pain     better, sustains consistent plasma concentrations, decreases overall narcotic requirement,     results in no additional adverse events, and is safe, even in children, across several     studies. Since the standard of care is non-methadone narcotic usage to manage the significant     pain of complex spinal surgery cases, it is understandable that methadone could be a     desirable alternative to promote sustained pain control and early ambulation in these     patients. The goal of this study is to compare the effect of a single dose of methadone     administered intraoperatively in enrolled spinal fusion patients to their historical controls     given fentanyl and morphine, and determine if more sustained pain control during the first     few days after surgery provides a better subjective experience for the patient with less     pain, which allows them to ambulate and leave the hospital sooner than patients given a     standard regimen.   "
22617|NCT02989584|"     The purpose of this study is to test the safety of the study drug, atezolizumab, when     combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study     will help researchers begin to understand whether combining GC with atezolizumab is better,     the same, or worse than the usual approach of using GC alone.   "
22618|NCT02989571|"     The objective of this study is to compare the effects of intravenous fluid rate on the course     of labor in nulliparous patients who are undergoing labor induction and have an unfavorable     cervix. The primary hypothesis is that an increased rate of intravenous fluids will shorten     the length of labor in patients undergoing induction with an unfavorable cervix.   "
22619|NCT02989558|"     Ticagrelor administered with Acetylsalicylic Acid (ASA) will provide better cerebral     protection from microembolization in the cerebral circulation during Transcatheter Aortic     Valve Implantation (TAVI) and 30 days afterwards, than Clopidogrel plus ASA. This hypothesis     will be investigated by measuring the number of High Intensity Transient Signals (HITS) as     assessed with transcranial Doppler (TCD) on middle cerebral arteries.   "
22654|NCT02989077|"     This study will delineate the risk profile of patients with isolated cerebral or coronary     ischemia and those with combined disease. The study will also evaluate current management     status of those patients and any unmet needs.This aim is proposed to be achieved by studying     3 groups of patients with coronary, cerebral or combined ischemia. Anticipated each group to     be 1000 patients.   "
22620|NCT02989545|"     Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months     and is a devastating disease. The negative impact on quality of life has been consistently     demonstrated. The prevalence of FI is probably underestimated in most studies. Currently     conservative treatment is only modestly effective and surgical treatment is complex and     expensive with less than optimal efficacy.      The investigators developed an anal tape using a commercially available elastic band with a     special adhesive that is approved for use in the skin. A special design of the tape can be     applied to the skin surrounding the anus providing support and additional pressure forces to     the anal sphincter.      This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and     safety of this device in patients with FI. The primary endpoint will be improvement in     quality of life.   "
22621|NCT02989519|"     The purpose of this study is to determine efficacy of vaginal and oral progesterone after     tocolytic therapy in threatened preterm labor   "
22622|NCT02989493|"     Double-blind, placebo controlled, randomized controlled trial (RCT) for Alcohol Use Disorder     examining the effects of doxazosin, a norepinephrine alpha1 receptor antagonist, on stress     reactivity and clinical outcomes.   "
22623|NCT02989480|"     Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart     muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and     scar tissue. Sarcoidosis is a condition that can affect many organs but when it affects the     heart patches of inflammation can result in scarring, especially of the ventricles. Both     conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis can be treated     with inflammation suppressing treatment (steroids), as well as pacemakers and implantable     defibrillators which shock the heart back to normal rhythm. ARVC is usually treated with     implantable defibrillators. The diagnosis of either condition can be difficult and indeed     distinguishing the two can be extremely challenging. Increasingly nuclear scans (PET) are     used to identify inflammation in the heart in patients suspected of having cardiac sarcoid.     It is not known whether patients with ARVC have abnormal PET scans.   "
22624|NCT02989467|"     This research study is being done to compare the effects of Aprepitant and placebo on fasting     gastric volume, accommodation volume, satiation (fullness) and gastric emptying.   "
22625|NCT02989454|"     Acute stress induced (Tako-tsubo) cardiomyopathy (TTC) or broken heart syndrome, a condition     typically occurring after acute stress has a death rate similar to heart attacks and is     frequently associated with long-term symptoms (fatigue and exercise limitation). There are no     effective therapies. The investigators have recently showed that there is a profound shortage     of energy in the hearts of Tako Tsubo Cardiomyopathy patients in the days after acute     presentation with only partial recovery by four months. The investigators would now like to     establish whether this recovers after at least one year, or persists, and also to investigate     the mechanisms responsible for exercise limitation after recovery from the acute phase.   "
22626|NCT02989441|"     In patients under general anesthesia the investigators wish to investigate association and     covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo,     Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and     SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)   "
22627|NCT02989428|"     The aim of this study is to establish whether patients with mild primary hyperparathyroidism     (PHPT) have an increased risk of cardiovascular diseases. The primary outcome is to determine     whether arterial stiffness and blood pressure will decrease in patients with mild PHPT     3-month after parathyroidectomy (PTX).   "
22628|NCT02989415|"     The aim of this study is to assess the incidence of postoperative pulmonary complications in     patients undergoing mechanical ventilation during general anesthesia for robotic surgery, to     characterize current practices of mechanical ventilation and to evaluate a possible     association between ventilatory parameters and postoperative pulmonary complications.   "
22629|NCT02989402|"     This is a multicenter, prospective, phase IV study evaluating safety, tolerability and     effectiveness of rivastigmine 27 mg -15 cm2 transdermal patch prescribed in patients with     severe dementia of the Alzheimer's type as per discretion of treating physician.   "
22631|NCT02989376|"     The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular     imaging for selecting acute stroke patients for endovascular thrombectomy.   "
22632|NCT02989363|"     Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS)     surgeries and complex back surgeries   "
22633|NCT02989350|"     Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral     rehydration therapy is the key treatment. According to the 2014 guidelines developed by the     ESPGHAN probiotics may be considered in the management of children with AGE in addition to     rehydration therapy. Considering that evidence on L reuteri remains limited, the     investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in     children. Children vaccinated and not vaccinated against rotavirus will be evaluated     separately.      Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.   "
22634|NCT02989337|"     The purpose of the study is to determine serum inflammatory adhesion molecules levels in     hyperemesis gravidarum   "
22635|NCT02989324|"     Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second     Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections   "
22655|NCT02989064|"     This study will investigate the safety and tolerability of MAGE A10ᶜ⁷⁹⁶T cell therapy in     subjects who have the appropriate HLA-A2 tissue marker and whose melanoma or bladder or head     and neck tumor has the MAGE-A10 protein expressed. This study will take a subject's T cells     and give them a T cell receptor protein that recognizes and attacks the tumors.   "
23733|NCT02975011|"     A prospective study investigating the effectiveness and safety in lumbar stenosis patients     receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean     Medicine through assessment of pain, functional disability, and quality of life   "
22710|NCT02988349|"     caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited.     Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate®     Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks.     Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before     and after the treatment for laboratory analyses.   "
22636|NCT02989311|"     Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia     (IDA), which adversely affects their growth and cognitive development. In-home iron     fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA     by ensuring that the iron needs of infants and young children are met without changing their     traditional diet. In order to optimize iron absorption timing of MNP consumption might as     well be important. This is because hepcidin, a key regulator of systemic iron balance, shows     a circadian increase that may influence morning versus afternoon iron absorption from the     MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit     iron absorption from a second dose, consumed close in time to the first dose.      To determine the difference between i) morning versus afternoon iron absorption and ii)     consecutive versus alternate day iron absorption, investigators will enrol 20 infants from     Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2     test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in     the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting     of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days     and 1 alternate day. In both studies, fourteen days after the last test meal administration,     a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and     inflammation status parameter will be determined at baseline and endpoint. Hepcidin     concentrations will be measured before the morning and afternoon meals (study 1) and after     second consecutive meal (study 2).      Knowing the effect of time on the expected iron absorption will inform decisions on the ideal     timing of MNP to cover the infant's requirement for absorbed iron.   "
22637|NCT02989298|"     Brief Summary: The investigators are registering all PD patients at recruited hospitals and     developing a PD database in China. Patients will be followed up every 3 months, and both     baseline and follow-up information will be collected and input into the registration system.     The patient survival, technical survival, peritonitis rate, longitudinal changes of residual     renal function and peritoneum function, and quality of life for PD patients, etc, will be     compared using the PD database.   "
22638|NCT02989285|"     Human Immunodeficiency Virus (HIV) remains in infected patients receiving highly active     antiretroviral therapy (HAART) for many years. Stopping HAART usually leads to re-emergence     of small reservoirs of latent (inactive) HIV that reside inside certain types of infected     cells, that can replicate and cause a full HIV infection. Chronic HIV infection also leads to     long-term immune activation which is associated with higher incidence of serious non-AIDS     events including cardiovascular disease and cancers. Thus HIV+ patients must remain on HAART     indefinitely or replication-competent latent HIV reservoirs must be eradicated.      The central nervous system (CNS) is a sanctuary site for latent HIV. For example,     HIV-associated neurocognitive disorders (HAND) develop and persist in about 40% of HIV+     persons despite long-term HAART and viral suppression in blood and cerebrospinal fluid (CSF).     Continued CSF immune activation is also frequently observed despite viral suppression. Both     of these are likely to indicate ongoing low-level HIV replication in the CNS.      Several strategies to eradicate latent HIV are being explored. One of these, known as shock     and kill involves awakening latent HIV and inducing replication to make it more     susceptible to host immune responses and HAART. However, there are several major caveats to     its application in the CNS such as the risk of triggering a serious immunoinflammatory     response (e.g., meningoencephalitis) that cannot be easily controlled by HAART. Other     eradication strategies may also be problematic given that many latency-reversing agents have     limited penetration of the blood brain barrier and limited efficacy in astrocyte cells. To     improve the effectiveness of new eradication therapies it will be crucial to develop better     methods to identify and quantify latent HIV reservoir sites with greater precision.      To identify potential HIV latency biomarkers in the CNS, the investigators will study HIV+     patients stable on HAART and virally-suppressed in blood and CSF over 24 months. Because such     a marker should be associated with HAND or its development without changing significantly     with HAND progression, half of the sample will have HAND at study entry and half will not.     Patients will undergo neuropsychological testing and give blood and CSF samples every 6     months to identify candidate biomarkers and track them prospectively against HAND development     and progression. MRI brain scan will also occur at study entry and after 24 months.   "
22639|NCT02989272|"     It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is     that pre-treatment with magnesium sulfate, due to its action at the neuromuscular     junction,potentiate the duration of deep neuromuscular block following rocuronium     curarization in patients undergoing general anesthesia. Magnesium sulphate has gained     prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of     neuromuscular blockade among other functions.      The deep neuromuscular block is defined as the one obtained by the absence of response to the     sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic     counts . There is no literature description of the role of magnesium sulphate in Duration of     the deep neuromuscular block obtained after the muscle relaxation of patients with rocuronium     This study is justified because extending the clinical duration of neuromuscular blockers may     translate into gains for surgeries that require deep and long-lasting muscle relaxation as in     laparoscopic and robotic surgeries. This block allows lower inflation pressures of the     pneumoperitoneum to be obtained, as a result, there is a lower inflammatory and     cardiorespiratory repercussion for the patient   "
22640|NCT02989259|"     In this study, the investigators try to evaluate the efficacy and safety of apatinib in     advanced non-squamous head and neck cancer and to validate the correlative biomarkers.   "
22641|NCT02989246|"     This pilot study tests the feasibility of using a computerized ventilator management protocol     seeking to encourage lung protective ventilation during the acute phase of ventilation, and     esophageal manometry based titration of ventilator settings during the weaning phase of     ventilation, for children with acute respiratory failure. The investigators hypothesize that     such an approach will reduce time on mechanical ventilation, largely by preserving diaphragm     muscle function.   "
22642|NCT02989233|"     In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13,     were divided into 12 equal experimental groups according to their ages and gender. They were     all considered to have poor hygiene. Only one out of the three different education methods     (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP     and theoretical test points from the baseline to the 6th months were evaluated.   "
22643|NCT02989220|"     Some women experience the pain of miscarriage on numerous occasions. Studies show that these     women experience feelings of anxiety and distress during the early stages of a new pregnancy     as they worry another miscarriage will occur. This study will investigate whether a coping     strategy, developed for a similar group of women, would be acceptable and useful to women     suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A     secondary aim of the study is to develop a deeper understanding of the experiences and     feelings of women in the early stages of a new pregnancy, following multiple miscarriages.   "
22668|NCT02988895|"     This is a prospective, single-arm, open-label, safety, usability and tolerability trial of     Strontium 90 (Sr90) beta radiation episcleral brachytherapy in subjects receiving aflibercept     therapy pro re nata (PRN) for the treatment of early neovascular Age-related Macular     Degeneration (nAMD) lesions. Secondary aims are to observe clinical outcomes of area of     leakage, sub-retinal fluid, lesion size, visual acuity, and anti-vascular endothelial growth     factor (anti-VEGF) treatment burden.   "
22669|NCT02988882|"     The purpose of this study is to evaluate the efficacy and safety of OTX-DP compared to     Placebo Drug Delivery Vehicle (PV) for the treatment of the signs and symptoms of chronic     allergic conjunctivitis.   "
22644|NCT02989207|"     The aim is to perform a randomised feasibility trial preceding a large prospective randomised     controlled trial (RCT) comparing three surgical methods - trabeculectomy with Mitomycin C     (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black     African/African Caribbean patients with Primary Open Angle Glaucoma (POAG) living in London.      The UK Office of National Statistics estimated that among the population of England in 2007,     approximately 4.3% were of African/African-Caribbean background, while in large cities such     as London and Birmingham about 20% of the population is of African/African-Caribbean origin.     For eye units in these cities, managing glaucoma in this population is challenging and we     need to identify a better alternative to our current standard surgical treatment.      There is now evidence from one RCT which shows better overall outcomes from tube surgery in     comparison to trabeculectomy for glaucoma. However, this study did not address black     populations specifically and did not address the potential role of MMC in tube surgery.      This feasibility study will enable us to design a fully powered RCT with the aim of     determining how best to optimise the surgical treatment of POAG in black populations, by     comparing outcomes in three types of glaucoma surgery.   "
22645|NCT02989194|"     This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the     safety and tolerability of VIS410 in subjects with uncomplicated influenza.   "
22646|NCT02989181|"     The aim of this randomized controlled study is to investigate the effect of continues     positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and     concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function     measured by magnetic resonance (improvement of at least 4%) after six months treatment with     CPAP.      The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality     of life.   "
22647|NCT02989168|"     This is an open label study in which eligible IPF subjects who are using supplemental oxygen     at rest will receive GBT440 orally daily.   "
22648|NCT02989155|"     The purpose of this study is to determine the need for a blood transfusion during surgery and     to evaluate the levels of certain proteins in the blood when given tranexamic acid.   "
22649|NCT02989142|"     The project focuses on prevention of major pregnancy and birth related complications :     pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section     (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90%     percentile of birth weights for the specific pregnancy duration.      The investigators focus on the pre-conception period, i.e. the pre-conception period of the     2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to     decrease the complications rate in their 2nd pregnancy.      Women with an excessive gestational weight gain have obtained the extra weight during a     rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy. This     characteristic distinguishes the target group from the general population with     overweight/obesity, in whom the extra weight was acquired during many years and independent     from a pregnancy, making a behaviour change more complex.      The coaching intervention combines face-to-face counselling with the use of a mobile App     connected to medical devices (scale and pedometer). The app monitors important indicators     (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through     established behavioral change techniques, and is specifically tailored for women with     excessive weight gain during the previous pregnancy.      The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next     pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained     during the next pregnancy.   "
22650|NCT02989129|"     The goal of this clinical research study is to learn about the effectiveness of quercetin in     treating and preventing CINP. Researchers also want to learn if quercetin has an effect on     participant's quality of life.   "
22651|NCT02989116|"     The purpose of this study is to determine whether a daily executive training to cognitive     inhibition, working memory or mindfulness as compared to an active control condition has a     near- and far-transfer impact on brain and behavioral measures as collected in children aged     9-10 years, either born preterm or full-term.   "
22652|NCT02989103|"     Background:      Hyperthyroidism is a common disease. It is very common for women. It is usually treated with     Radioiodine (I-131). Some people think that this might cause cancer, even many years later.     Past studies of people with hyperthyroidism have not been clear about cancer risks after     I-131. Researchers want to look at a group of people with the disease who got I-131 many     years ago. They want to look at how their health was months and years later.      Objective:      To learn more about disease risks in relation to radiation from I-131 treatment for     hyperthyroidism.      Eligibility:      People who were part of the previous study. These are people who were diagnosed with     hyperthyroidism at U.S. and U.K. hospitals from 1946 to 1964. About 95% of the participants     have already died.      Design:      Researchers will examine data already collected by the past study. This includes data on     participants later cancers and other health outcomes after they had I-131 treatment.      Researchers will compare that data to a National Death Index search.      This was already done for data up through 2003. This study will cover 2004 2014.      Researchers will not be in touch with study participants or their next of kin.   "
22653|NCT02989090|"     Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to     efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an     overall improvement in the quality of care for such patients. Despite the efficacy of remote     monitoring of ICDs and the satisfaction of patients and providers with the process, there is     a desire from patients to have access and view ability of the data their ICD is transmitting.     However, methods for making ICD device data directly available to the patients are not     currently in place. This study aims to elicit the impact of standardized remote monitoring     ICD data to patients through an electronic personal health record (ePHR) on patient     engagement, healthcare utilization, and patient-provider communication. For this study,     patients with an ICD manufactured by St. Jude Medical and that are undergoing remote     monitoring through the remote management system, Merlin.net™, will receive a standardized     format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview     Health. The standard format for the electronic remote monitoring ICD data, as it is delivered     to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider     attitudes and perceptions regarding the value of the Patient Notification Summary, its impact     on clinic workflow, and patient-provider communication will be collected.   "
22656|NCT02989051|"     Rationale: Fluid overload is a common complication in children who are admitted to the     pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause     for admission to the PICU and forms an uniform group with a single organ failure. In these     critically ill children, fluid overload is associated with adverse outcome. Restricting the     volume of fluids already in an early stage of ICU admission may prevent fluid overload during     mechanical ventilation and thus improve clinical outcome. However, at the same time fluid     restriction may interfere with appropriate energy and macronutrient intake that is needed for     recovery.      Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive     fluid management protocol and investigate its effect on the occurrence of fluid overload in     mechanically ventilated children with acute infectious lung disease.      Study design: Single-center prospective randomized feasibility and pilot study in preparation     of a multi-center randomized controlled trial (RCT).      Study population: Mechanically ventilated children with (suspicion of) acute infectious lung     disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's Hospital,     Academic Medical Center, Amsterdam.      Intervention: Patients receive either liberal (control group) or a restrictive (experimental     group) fluid treatment, while ensuring appropriate caloric intake.      Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body     weight during the first week of mechanical ventilation. Secondary outcomes (in preparation of     the larger multi-center RCT) include: mortality, duration of mechanical ventilation and     oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to     treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as     energy and protein intake are studied.      Both fluid management protocols reflect a variant of current clinical practice, hence will     not provide extra burden or risk to patients included in the study. Patients will be     randomized to either of the fluid protocol arms on admission to the PICU (at start of     mechanical ventilation). Patients included in the restrictive fluid treatment arm might have     direct benefit from the study if indeed fluid overload is less common in this group.   "
22657|NCT02989038|"     The purpose of this study is to evaluate reactions to, and choices to self-administer,     cigarette smoke with varying nicotine content among low-frequency, non-dependent     adolescent/young adult smokers between the ages of 18-25 years.   "
22658|NCT02989025|"     The purpose of this study is to learn if giving 17-hydroxyporgesterone caproate (17 OHPC) to     mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby     outcomes.   "
22659|NCT02989012|"     Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled,     multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the     symptoms of influenza.   "
22660|NCT02988999|"     Prospective, randomized, double-blind, controlled-trial 30 subjects in each groups Group - I     consume pure D-allulose 5 g 3 times a day before meal to right after meal (with any liquid)     and Group - II control group with non-calorie sweetener erythritol 5 g 3 times a day before     meal to right after meal (with any liquid) Total number: n = 60 Either males or females,     non-diabetic, aged > 18 years old with BMI ≥ 25 kg/m2      Primary objectives Efficacy      1. Compare the efficacy of pure D-allulose (psicose) plus conventional therapy on 1.1     visceral fat area (VFA), subcutaneous fat area (SFA), total fat area (TFA) change 1.2 body     weight, BMI and body fat percentage (with impedance method) change after 24 weeks of     D-allulose (psicose) consumption to erythritol consumption and between pre- and     post-intervention.      Secondary objectives 1. Efficacy of pure D-allulose (psicose) plus conventional therapy     versus erythritol plus conventional therapy on 1.1 insulin resistance, fasting plasma     glucose, HbA1c 1.2 adiponectin, leptin and tumor necrosis factor-alpha, lipid profiles (total     cholesterol, HDL-C, LDL-C, triglyceride, very low-density lipoprotein, LDL, chylomicron),     apolipoprotein AI, apolipoprotein AII,apolipoprotein B48, apolipoprotein CIII and     apolipoprotein E, free fatty acids 1.4 waist circumference, hip circumference, waist/hip     ratio      Safety      1. Safety of the study by comparing with conventional therapy, monitoring blood pressure,     pulse rate, hematological parameters and urinalysis   "
22661|NCT02988986|"     This is an open label phase II clinical trial to determine the efficacy, toxicity, and safety     of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative breast     cancer.   "
22662|NCT02988973|"     The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted     from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in     the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled     cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted     from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term     treatment of ASP1517 (52 weeks).   "
22663|NCT02988960|"     This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and     pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or     recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as     combination therapy with nivolumab in participants with advanced solid tumors.   "
22664|NCT02988947|"     The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience     Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and     prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee     Arthroplasty   "
22665|NCT02988934|"     The purpose of this study is to create a registry (collect data and keep it in a research     database) to learn more about two methods of taking small tissue samples from your esophagus     (the esophagus is the tube that carries food and liquid from your mouth to your stomach.).     The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples)     from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.      By recording the results of all of your biopsies over many years, it may be possible to find     out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn     develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and     which patients with Barrett's esophagus develop precancer and cancer. The data from your     biopsies will be used to determine the best way to diagnose esophageal disease.      You are being asked to participate in the study because you are receiving an upper endoscopy     (a procedure where a tube with a light and camera are inserted in your mouth and down your     throat) with forceps and brush biopsies of your esophagus as part of your standard clinical     care, and you are between the ages of 18 and 80.   "
22666|NCT02988921|"     Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI)     are advancing imaging technologies that have potential to overcome limitations of     conventional staging methods, radiation treatment planning and the assessment of tumor     response in esophageal or esophagogastric cancer. This study aimed to explore the value of     MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume     delineation as compared to CT simulation for patients with unresectable or potentially     resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT     texture features are also extracted before and during treatment to establish a model to     predict the prognosis of patients.   "
22667|NCT02988908|"     A comparison of memory training with and without donepezil.   "
22670|NCT02988869|"     The overall objective is to asses the bronchodilator effect of once daily     Tiotropium/Formoterol combination delivered via Discair® compared to Tiotropium (q.d.)     monotherapy delivered via Handihaler and tiotropium (q.d.) delivered via Handihaler +     formoterol (b.i.d) delivered via Aerolizer free combination treatment in patients with stable     moderate to severe COPD.      Spirometric measurements (FEV1, FVC) will be performed for a period of 24 h at 12 different     times: pre-treatment (15 min prior to the first dose) and post-treatment (30. min, 60 min [1     hr], 120 min [2 hr], 180 min [3 hr], 240 min [4 hr], 360 min [6 hr], 480 min [8 hr], 600 min     [10 hr], 720 min [12 hr], 840 min [14 hr],1440 min [24 hr].   "
22671|NCT02988856|"     Objective 1: Determine the safety and feasibility of externally mounted magnets for extended     management of chronic eyelid movement disorders by measuring visual acuity and corneal and     skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the     relative efficacy of external magnetic devices by comparing them to externally mounted lid     weights and ptosis crutches using rating scales and video analysis of blink biomechanics.   "
22672|NCT02988843|"     This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab     for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on     imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein (AFP)     or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits and     determined by treating physician to be clinically significant. Patients unable to receive 2nd     line of platinum-based chemotherapy due to toxicity or refusal would also be eligible.   "
22673|NCT02988830|"     The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in     chronic lumbago after 12 months of treatment.   "
22674|NCT02988817|"     The purpose of the trial is to establish the tolerability of HuMax-AXL-ADC in a mixed     population of patients with specified solid tumors   "
22675|NCT02988804|"     The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the     incidence of complications is low, hypertensive episodes during surgery and awakening and     cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or     vomiting during the early postoperative period must be avoid to protect the patient from CSF     leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a     better haemodynamic profile and less incidence of cough in some surgical procedures and it     could help minimizing the risks after EETS   "
22676|NCT02988791|"     Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months:     paroxysms of irritability, fussing, or crying that start and stop without obvious cause;     episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least     1 week; and no failure to thrive. The condition is very common in the first 4 months of life     (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive     and inconsolable crying without an identifiable cause. Infantile colic cause considerable     stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all     pediatric visits in the first 4 months of life) and frequent formula changes.      The pathophysiology of IC is still poorly defined, but differences in gut microbiota     composition seem to be involved. In particular, differences in the number and species of     Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects     with IC, and it has been postulated that these alterations could be responsible for an     abnormal gas production within gut lumen resulting in distension and abdominal pain. These     findings suggest the potential role of probiotics as preventive and therapeutic strategy for     the IC.   "
22677|NCT02988778|"     This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral     Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients     will receive Astrazeneca medication. There is no placebo group.   "
22678|NCT02988765|"     Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in     which the preoperative evaluation is critical to address surgery between sentinel node biopsy     or radical groin lymphadenectomy.   "
22679|NCT02988752|"     This study was a non-inferiority trial with masked data analysis. Individuals ranging from 18     to 60 years from both genders that met the pre-defined criteria were included. This study was     carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de Informatica-UFPE.     Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were performed for each     eye of the individuals, under midriatic conditions. Evaluations were done by examiners who     did not know previously results obtained from other equipment. Data was collected by the main     researcher of this research. This study was approved by the ethics committee before it     started and all research members signed the TCLE agreement. The statistical test employed in     this study was Pearson Correlation test.   "
22680|NCT02988739|"     It is the aim of the present study to compare the immunogenicity induced by a laser-assisted     epidermally administered seasonal influenza vaccine to an intradermally administered seasonal     influenza vaccine.   "
22681|NCT02988726|"     RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma     provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy     suggest that it may prove beneficial in the treatment of adults with a recurrent/residual     Neurofibroma or Schwannoma.      PURPOSE: This study is being performed to determine the effects (good and bad) that     Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.   "
22682|NCT02988713|"     This is a prospective, multi-center, non-randomized, exploratory, single-arm study     characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing     a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial   "
22683|NCT02988700|"     Caudal analgesia along with general anesthesia is a very popular regional technique for     prolonged postoperative analgesia in different pediatric surgical procedures where the     surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for     approximately 4-6 hours.      Recently, the use of spinal anesthesia in infants and children requiring surgeries of     sub-umbilical region is gaining considerable popularity worldwide.      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal     anesthesia as an alternative to general anesthesia in infants and children undergoing     surgeries of sub-umbilical regions.   "
22684|NCT02988687|"     This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period of     six months and collect valuable pilot data to evaluate feasibility of a larger study and     treatment tolerability and compliance. The effect of rhGH on cognitive function, depression,     fatigue, sleep quality, and QOL will also be collected. This exploratory study will also     provide important information about recruitment and AGHD screening procedures in military     settings.   "
22685|NCT02988674|"     The objective of this study is to access retention rate, persistence and adherence in     population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis     (PsA)) participants treated with adalimumab in routine clinical settings in the Russian     Federation.   "
22686|NCT02988661|"     The purpose of this research is to examine whether the Chronic Disease Self-management     Program (CDSMP) would improve health outcomes and reduce health care use in African American     women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based     self-management education program that has been shown to help people with chronic conditions     to take control of their health problems. This study focuses on African American women with     SLE because the CDSMP has not been widely studied in this population.   "
22687|NCT02988648|"     The purpose of this phase I/II study is to evaluate the safety and clinical activity of     Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that     overexpresses functional Na/I symporter. The study will enroll patients with metastatic     breast cancer who have had clinical and/or radiographic evidence of disease progression on     prior hormonal and/or chemotherapy.   "
22688|NCT02988635|"     This study compares two types of care - Standard Oncology Care (SOC) and SOC with early     palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see     which is better for improving the quality of life of patients with advanced lung, pancreas,     gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure     patients' quality of life.   "
22689|NCT02988622|"     The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to as     Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional laser     (referred to as CO2 Laser in this application) to determine if one is superior to the other     in improving the appearance of scars over a series of three treatments. In addition, the     investigators hope to identify a more cost-effective method to improve the appearance of     scars caused by surgery or trauma.   "
22690|NCT02988609|"     This study assess the putative persistence of neural damage using resting state fMRI after     concussion in rugby player once they have clinically recovered. The hypothesis is that     despite a clinical recovery (absence of symptoms; neurological and neuropsychological     examination returned to normal) connectivity map obtained using resting state fMRI are     significantly different from a group of control subjects.   "
22691|NCT02988596|"     Approximately 420 professional and amateur athletes will participate in rehabilitation during     recovery after sports-related concussion. Participants will be cluster randomized, by study     site, to a specific study arm. Participants will complete post-injury assessments and the     intervention of their randomized group aimed at understanding the effects of a     multidimensional rehabilitation protocol versus enhanced graded exertion on clinical     recovery, return to play, and patient outcomes after sport related concussion   "
22692|NCT02988583|"     Silicone oil has been used as a surgical tool in complicated retinal detachment surgery.     There are some complications occurring in pars plana vitrectomy with silicone oil tamponade.     Silicone oil emulsification is one of the complication that may result in severe sequels that     are difficult to treat. It is believed that low viscosity silicone oil has more risk to     develop emulsification than high viscosity silicone oil. Up to now, however, there is no     conclusive guideline that which types of silicone oil is suitable for these complicated     retinal detachment surgeries and what is the appropriate time to remove the oil. This     prospective study aims to study the silicone oil emulsification comparing between low     viscosity and high viscosity silicone oil after complicated retinal detachment surgery.   "
22693|NCT02988570|"     In recent years, several studies confirm that some of preterm children have language     developmental disabilities, in production, in comprehension, or in written language. These     language impairments lead to learning disabilities. There are, however, contradictions     concerning the origin and nature of language dysfunctions. Some studies find lexical     disorders (number of words used by the child), others preferentially phonological disorders     (sounds used in the language), others also disorders of the morphosyntaxe (organization of     the sentences) and fragilities that affect pragmatics (understanding situations).      The computer-evaluation of the language is carried out at five and a half year coupled with     the medical and neuropsychological examinations. The language assessment lasts 30 to 45     minutes per child. It is carried out using a laptop computer that allows the submission of     stimuli and recording of the child's responses. The language evaluation scale is the battery     CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language     evaluation. The assessment includes three tests: comprehension of words and phrases,     production of words and phrases, and judgment of sentences. Each time, the child sees images     and hears words or phrases. Sometimes he has to say what he sees on the computer screen.      As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years     in the context of the follow-up of children born very preterm.      The evaluation proposed to the child in this research will be carried out at a significant     period of development, before writing. This assessment will not only assess the structure of     the child's language, but also determine if there are possible difficulties in learning to     read and write.      The expected benefits for the health of the children included in the trial therefore concern     the detection or characterization of any developmental fragilities affecting the language.     These screenings or characterizations will make it possible to advocate a speech     rehabilitation if necessary.   "
22694|NCT02988557|"     The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and     dynamic electromyography recordings, will be studied in children with bilateral spastic     cerebral palsy during level walking, and before and after a training on a treadmill with a     sloped surface (7°). Data will be compared with those obtained in a sample of typically     developing (TD) children (controls)   "
22695|NCT02988544|"     The aim of the study is to determine if collapsing an embryo (or making it fold compactly by     taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in     assisted reproductive technology (ART).      Women coming to our ART center will be randomized in two groups : the collapsing group and a     control group.      Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be     determined in each group and correlated to pregnancy occurrence.   "
22696|NCT02988531|"     To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary     artery disease.   "
22709|NCT02988362|"     The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan     16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male     volunteers.   "
22697|NCT02988518|"     Bipolar disorder is a major health concern. Intercritical periods are marked with residual     symptoms, both thymic and cognitive, which affects quality of life of patients, but also the     quality of observance. The implementation of cognitive remediation programs could be     interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar     patients with memory complaints included in the program named COGMED, targeting the working     memory.      The impact of this program on compliance, quality of life, and memory complaints will be     evaluated.      The investigator will measure whether there is a correlation between working memory and     overall performances.      Finally, the investigator will try to achieve a profile of bipolar patients in whom the     Cogmed program is particularly effective on a plan of overall performance.   "
22698|NCT02988505|"     Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical     guidelines emphasize the role of compression therapy by prescription medical devices. Even in     a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist     due to the price and reimbursement setting processes. OOPP may threaten the equity of care     and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for     lymphedema patients in France.      A prospective, multicenter study will be conducted in France in 2014 on patients with     lymphedema. Household ability to pay will be specified by net income and OOPP will be     assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,     nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory     and voluntary health insurance reimbursements will be considered. We will combine     concentration curves and concentration indices to assess the distributive effects.   "
22699|NCT02988492|"     The newest generation of stent--‐retrievers results in higher recanalization rates and faster     recanalization time compared to older generation endovascular therapies for acute stroke.     Advanced neuroimaging can potentially improve the assessment of infarct core and inform     decision--‐making in patients being considered for endovascular therapy. Evaluation of     infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation of     CTP in predicting core infarct in acute stroke has been limited because recanalization status     was lacking. In addition, final infarct size may be underestimated on NECT compared with MRI.     These two limitations can now be addressed: the new generation of stent--‐retrievers allows     accurate determination recanalization time; evaluating the test characteristics of CTP using     24 hour DWI--‐MRI as the reference standard can be readily performed.      We aim to prospectively investigate the sensitivity and specificity of whole--‐brain CTP in     predicting 24 hour DWI--‐MRI infarct in patients with acute proximal anterior circulation     occlusions successfully recanalized with endovascular treatment.   "
22700|NCT02988479|"     Primary lymphedema is a chronic condition posing a high burden on patients. Clinical     guidelines emphasize the role of compression therapy by prescription medical devices. Even in     a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist     due to the price and reimbursement setting processes. OOPP may threaten the equity of care     and drive patients to forgo care. The investigators aim was to analyze the distributive     effects of OOPP for primary lymphedema patients in France.      A prospective, multicenter study will be conducted in France in 2015 on patients with primary     lymphedema. Household ability to pay will be specified by net income and OOPP will be     assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,     nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory     and voluntary health insurance reimbursements will be considered. The investigators will     combine concentration curves and concentration indices to assess the distributive effects.   "
22701|NCT02988466|"     This is a single institution phase II study of a reduced intensity conditioning (RIC)     followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with     diagnosis of hematologic malignancy. Conditioning will consists of fludarabine,     cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a     melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI)     >3. This study uses a two-stage phase II design with accrual goal of 44 patients, using 22     patients separately for arms A and B.   "
22702|NCT02988453|"     A single blind, randomized controlled trial to investigate the efficacy of a newly manualized     psychotherapy Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)     in comparison with Treatment As Usual (TAU).   "
22703|NCT02988440|"     A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of     PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in     first line. There will be a dose escalation part and a dose expansion part.   "
22704|NCT02988427|"     We will develop a new measure of patient engagement/activation specific to the context of     diabetes self-care   "
22705|NCT02988414|"     Prospective study at Duke University Hospital comparing the Karius Infectious Disease     Diagnostic Sequencing Assay to blood culture results in admitted patients with     bacteremia/septicemia.   "
22706|NCT02988401|"     This study will evaluate if giving insulin that is administered in the nostrils (intranasal)     is safe and tolerable for people with multiple sclerosis (MS). It is also being done to     evaluate if intranasal insulin improves cognitive function in people with MS and to evaluate     how it might be working.   "
22707|NCT02988388|"     The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung     tissues from donors and preparing and distributing collections of tissue specimens to     researchers within and outside the LTRC. Collections of specimens will be linked to     individual clinical data appropriate to the particular disease. The primary goal of the LTRC     is to identify participants with suspected lung cancer or metastatic disease who are willing     to provide informed consent for research use of their specimens and data. Secondarily, the     LTRC investigators intend to collect clinical data, limited exposure data, physiologic     studies, and radiographic studies from these participants.   "
22708|NCT02988375|"     The primary objective of the proposed research is to determine the efficacy of Digital     Cognitive Behavior Therapy (dCBTI) in preventing the incidence of depression among     insomniacs. In addition, we will identify salient sociological/environmental variables, such     as socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care     responsibilities (i.e., having children under the age of 3), stigma, that moderate the     effects of this intervention.   "
22712|NCT02988323|"     Sport concussions are among the most commonly occurring injuries in sport and recreation and     pose significant public health implications for Canadians. Many individuals who sustain a     concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may     suffer from persistent symptoms. Little research is currently available evaluating the     effects of treatment for individuals who are slower to recover following sport-related     concussion. An initial RCT identified a significant treatment effect in individuals with     persistent symptoms of dizziness, neck pain and/or headaches following sport-related     concussion when treated with a combination of cervical and vestibular physiotherapy compared     to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level     aerobic exercise in combination with sport specific training may also be of benefit to     facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016).     Further evaluation of these treatments is required to better understand the effects of each     treatment in isolation and in combination. This trial will have the ability to inform future     multifaceted clinical trials as well as clinical practice. Ultimately, identification of     optimal treatment paradigms will lead to a decrease in persistent symptoms and functional     alterations in children and youth from this commonly occurring injury.   "
22713|NCT02988310|"     Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15     healthy individuals will be participants of the study. Participants with lower limb loss will     evaluate with the following assessment tools: Demographic datas; age, gender, height, body     mass will be recorded. Gait parameters (step length, variation of step length, time on each     foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred     speed.   "
22714|NCT02988297|"     The purpose of this study is to determine whether nebulized RNS60 is effective in the     treatment of amyotrophic lateral sclerosis (ALS).   "
22715|NCT02988284|"     Three hundred healthy individuals will be participants of the study. Participants will     evaluate with the following assessment tools: Demographic datas; age, gender, height, body     mass, will be recorded. Gait parameters (step length, variation of step length) will evaluate     with Gait trainer Biodex 2, at participant's preferred speed.   "
22716|NCT02988271|"     Meditation is an approach that focuses on the connection between mind and body that uses     techniques with breath, sound, or movement. It has been the focus of research because of its     possible benefit for lowering distress and improving health and quality of life. The     meditation techniques in this study are already used in clinical practice. They are based on     the Tibetan tradition and focus on use of sound and breathing techniques.      The goal of this research study is to learn how self-administered meditation (meditation     participant completes on their own) can improve participant's mood-related symptoms, such as     depression and anxiety. Researchers also want to learn how to deliver pre-recorded     meditations using a computer-based application (program, or app).   "
22717|NCT02988258|"     The study will test the hypothesis that CMV TCR-transduced T cells, at a specific T-cell     dose/kg, can generate a functional CMV immune response post-transplant, where CMV-specific     donor T cells cannot be isolated by conventional means. This will be tested in the context of     adult HLA-matched sibling allogeneic HSCT.      In the proposed trial, an HLA-A*0201-restricted CMV pp65-specific T cell receptor (TCR) will     be introduced into donor T cells via ex vivo GMP retroviral transduction. Donor T cells will     be isolated from peripheral blood following a simple venesection procedure. The CMV     TCR-transduced T cells will be tested for TCR expression, CMV-specific cytokine secretion and     microbiological contamination before being frozen and stored at -80C. CMV seropositive     transplant recipients will be tested weekly for CMV reactivation by quantitative PCR on     peripheral blood. On first detection of CMV DNA > 200 copies/ml, 104 (cohort 1) or 105     (cohort 2) bulk CMV TCR-transduced T cells/kg recipient weight will be infused into the     patient.      Blood will be taken regularly to determine persistence and expansion of the CMV     TCR-transduced T cells. Weekly CMV PCR will be continued. Patients will be examined at     appropriate intervals (daily if inpatients, twice weekly in BMT clinic if outpatients) for     the development of graft versus host disease (GVHD) or other potential side effects.   "
22718|NCT02988245|"     Hypertension is one of the most important preventable contributors to disease and death in     the United States and represents the most common condition seen in the primary care setting.     Approximately 78 million adults living in the U.S. have hypertension with more than 5 million     new diagnoses made each year. Unfortunately, despite a significant impulse in the medical     community to move towards an individualized medicine approach to patient centered     treatment, the current clinical treatment strategy is based on a set algorithm which does not     take into account individual patient differences. As a result hypertension is often     sub-optimally treated based on population averages, rather than a person's genetic make-up,     with significant burden on our health care system. In fact, 40% of patients who are adherent     to their blood pressure therapy (taking their medicines as prescribed by their clinician) do     not have their blood pressure under control. Previous work has demonstrated significant     functional polymorphisms within the kidney, vessels, and heart that will likely predict a     patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a     retrospective design, has determined that the addition of genetic knowledge to prescribing     can improve therapeutic guidance and decrease the time to blood pressure control     significantly. Despite this, to date, there are no prospective trials to guide blood pressure     therapy using multiple organ systems that are important in the three most common classes of     drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to     determine the efficacy of genetically guided therapeutic options for pharmacologic treatment     of essential hypertension in newly diagnosed patients.   "
22719|NCT02988232|"     The Purpose of this trial is to investigate the efficacy and safety of     Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain   "
22720|NCT02988219|"     This study evaluates the incidence of cardiac arrhythmias during the perioperative period in     patients undergoing open kidney cancer surgery in the lateral position. All the participants     will be randomly allocated to receive general (Group G) or combined epidural/general     anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will     be applied at the evening before the surgery, tracing continuously for a period of 24 hours     (7PM-7PM)   "
22721|NCT02988206|"     In this study，researchers will use personalized objects to assess patients' level of     consciousness in chronic patients in minimally conscious state (MCS).   "
22723|NCT02988180|"     Children in extreme poverty lack adequate care and face increased health risks. The earlier     poverty strikes in the developmental process, the more deleterious and long-lasting its     effects. There is, however, growing evidence that early interventions can prevent the     negative consequences. Such interventions are effective, particularly when they are of high     quality, organized at home and parents are involved. Recently, baseline assessment of     developmental and nutritional status of SOS children and children in extreme poverty in Jimma     region of South-West Ethiopia revealed that these children have developmental problems in     language, motor, social-emotional skills and nutritional status. The impact of play-oriented     stimulation activities integrated into the existing SOS basic program, on developmental     outcomes, has never been investigated in this context. The main objective of the study is,     therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS     program on the developmental outcomes of children living with foster families. This was done     by comparing the intervention children with their age-matched children (control), not     receiving the stimulation package. It was hypothesized that this package would significantly     improve the developmental skills of these children.   "
22724|NCT02988167|"     Knowing when to liberate critically ill patients from mechanical ventilation (i.e.     extubation) is of great importance as both prolonged ventilation and failed extubation are     associated with increased morbidity, mortality & costs. The study objective is to improve the     safety of extubation by harnessing hidden information contained in the patterns of variation     of heart and respiratory rate measured over intervals-in-time.   "
22725|NCT02988154|"     This study aims to investigate the efficacy of simulation in neurosurgical training.   "
22726|NCT02988141|"     A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese     Patients with Advanced EGFRm+ NSCLC   "
22727|NCT02988128|"     Post market surveillance registry   "
22728|NCT02988115|"     The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe     versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.   "
22729|NCT02988102|"     In pediatric age groups communication difficulties very sometimes may present further     obstacles in obtaining a detailed injury history and early identification of TBI symptoms.      Most emergency management protocols are focused exclusively on the identification of the     relatively small number of patients who may require operative intervention, as early surgery     is believed to improve outcome.   "
22730|NCT02988089|"     Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been     recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac     gastric cancer. Strongly evidence supports that H. pylori eradication is an effective     approach to reduce the incidence of those pathologies.   "
22731|NCT02988063|"     This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression     therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in     adults with severe venous disease of the great saphenous vein (GSV). All participants will     receive treatment with Varithena and compression therapy.      The purpose of this study is to assess whether the use of PEM to correct superficial axial     and varicose vein reflux is effective in improving healing of VLUs, over treatment with     compression alone.   "
22732|NCT02988050|"     Sixty patients were randomly allocated into two groups, group PD and group PR, thirty     patients in each group. Patients in PD group received propofol and dexmedetomidine     intravenous infusion and patients in PR group received propofol and remifentanil intravenous     infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean     arterial blood pressure, oxygen saturation, and side effects such as respiratory depression,     nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.   "
22733|NCT02988037|"     The investigators conducted a pre-post naturalistic study regarding changes observed     associated with a 15-week course of an adapted form of dialectical behaviour therapy for     adolescents. We measured frequency of self-harm prior to treatment and after treatment using     the Self-Injurious Thoughts and Behaviors Interview. We also measured changes using the     Suicide Ideation Questionnaire, Life Problems Inventory, Resiliency Scale for Children and     Adolescents.   "
22734|NCT02988024|"     The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005     oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting     conditions in healthy subjects between 18 and 50 years of age.   "
22735|NCT02988011|"     In this explorative randomized clinical study, the investigators aim to study metabolic,     cellular, and molecular changes that occur during weight loss in obese subjects with and     without type 2 diabetes. Using novel imiomics (imaging technique using PET/MR     bioinformatics) analyses to examine possible metabolic differences between energy restricted     diet and gastric by-pass surgery on whole-body and tissue specific insulin sensitivity,     glucose tolerance, metabolite and protein profiles, fatty acid metabolism, ectopic fat     content, and gene expression in adipose tissue. This study aims to identify novel biomarkers     and drug targets for type 2 diabetes as well as validate promising and established biomarkers     in an interventional model for improved glucose metabolism.   "
22745|NCT02987881|"     This study will evaluate whether the use of the Jawbone wristband monitor, in connection with     home-based exercise and nutritional counseling can be safely completed and improve     cardiorespiratory fitness (heart and lung health) in women with early stage endometrial     cancer who have undergone surgery.   "
22736|NCT02987998|"     The purpose of this study is to determine the feasibility and evaluate the safety of     delivering chemoradiotherapy, the usual approach to non-small cell lung cancer, in     combination with pembrolizumab (MK-3745), followed by consolidation pembrolizumab after     surgical resection. Consolidation therapy is treatment given following the initial treatment.      Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by     the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of     head and neck cancer. However, it has not been approved for use in other cancers such as     non-small cell lung cancer (NSCLC). Pembrolizumab is a monoclonal antibody that binds to the     surface of some cells of the immune system and activates them against cancer cells. It is not     chemotherapy.   "
28024|NCT02919072|"     The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl     3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ     undergoing unplanned Caesarean section.   "
22737|NCT02987985|"     The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)     technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce     postoperative respiratory depression in the post-anesthesia care unit and ward in children     with sleep-disordered breathing undergoing tonsillectomy when compared with traditional     opioid-containing techniques. It is expected that this OFA regimen will have a measurable     reduction on postoperative respiratory depression in children with sleep-disordered     breathing.   "
22738|NCT02987972|"     This study is designed to evaluate the safety, tolerability, and immunogenicity of two     different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The     primary hypothesis of the study is that the proportion of participants receiving V114 who     have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,     6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for     recipients of Prevnar 13™.   "
22739|NCT02987959|"     This is an open-label phase II study of TAK-228 for patients ≥ 18 years of age with complex     genomic sarcomas exhibiting Phosphoinositide-3 Kinase (PI3K) pathway dysregulation. Patients     must have surgically unresectable or metastatic disease that is refractory to at least one     prior line of therapy (not including neoadjuvant or adjuvant therapy in a curative setting).     Patients disease must also have evidence of progression prior to enrollment. The purpose of     this study is to determine the antitumor activity in this group of patients. Patients must     meet all eligibility criteria as detailed in section 10. A total of up to 33 patients will be     included in the study. Patients will undergo screening evaluations to determine eligibility     within 28 days of the first dose. All patients will be required to submit baseline tumor     samples for analysis. Patients who have had their tumors tested commercially for PI3K/     AKT/mechanistic Target of Rapamycin (mTOR) alterations will be assessed on a case by case     basis for eligibility and for determination as to whether additional tissue is required.      TAK-228 will be administered orally at 3 mg daily for a 21 day cycle. Clinical and laboratory     assessments will be made on day 1 of each cycle. Disease will be assessed by comparing     unidimensional tumor measurements on pre and peritreatment imaging (CT or MRI) after weeks 6,     12, 18 and every 12 weeks thereafter. Response will be assessed according to RECIST 1.1.     Therapy will continue until disease progression or unacceptable toxicity or withdrawal of     consent.   "
22740|NCT02987946|"     In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the     relatively long duration of surgery, the high occurrence of prolonged immobilization of     patients due to paresis of the legs or intracranial pathology causing inability to mobilise2.     Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause     hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in     attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity,     insufficient power of performed studies and lack of careful phenotyping and description of     risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the     optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with     adequate power and detailed information on patient related factors (malignancy, subarachnoid     haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and     postoperative immobilisation will allow us to identify the optimal treatment strategy for     high risk neurosurgical patients.      In the current study all patients that fulfil the inclusion criteria will be subjected to     post-operative systematic evaluation of VTE by echo-duplex investigation.   "
22741|NCT02987933|"     Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy     normals and may be sufficiently different to allow a high level of classification accuracy of     whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief     activation state using pain rumination to assess whether investigators can reliably find     differences between chronic pain sufferers and healthy normals.   "
22742|NCT02987920|"     Total knee arthroplasty (TKA) is one of the most painful orthopedic procedures. After TKA     surgery, postoperative pain relief may be achieved using a variety of techniques. Integral to     recovery and improved outcomes is early ambulation and mobilization. Achieving adequate     postoperative pain control while ensuring the ability to ambulate early can be quite     challenging.      Currently, in our country there has been a call to address prescription opioid use and abuse     due to a nationwide opioid epidemic. In light of this, improving our multimodal analgesic     protocol will serve to decrease reliance of opioid medications for pain control. Multimodal     analgesia is effective in decreasing total opioid consumption postoperatively.     Dextromethorphan is a low-affinity noncompetitive N-methyl-D-aspartate (NMDA) receptor     antagonist. It has a long history of clinical use with an established safety record. Studies     have shown that it has a positive effect as an analgesic.      In order to see if dextromethorphan will decrease opioid use, this study will look at two     patient groups undergoing total knee arthroplasty with the same preoperative, intraoperative,     and postoperative anesthetic plan with the exception of the addition of dextromethorphan to     one groups multimodal analgesic regimen. This study is designed as a double-blinded,     randomized, prospective cohort trial.   "
22743|NCT02987907|"     The current random, double-blind, controlled, clinical trial was designed to evaluate the     impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar     carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.   "
22744|NCT02987894|"     The purpose of this post-market registry is to collect and monitor ongoing safety and     performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™     Transferral Delivery System, when used as per IFU.   "
22746|NCT02987868|"     In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH)     increased 682% above baseline 120 minutes after oral administration of an amino acid-based     dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH     stimulation by ghrelin, we hypothesize that the supplement suppresses somatostatin, a know     inhibitor of both hGH and TSH. To test this hypothesis, we measured triiodothyronine (T3)     after administration of the amino acid-base supplement.   "
22763|NCT02987647|"     To evaluate the perception of the effectiveness of Hidrafemme® gels, Vagidrat®, Lubrinat and     Antrofi cream in improving vaginal moisture in postmenopausal women who are currently     registered options most current and available in the market in order to assess the     differences between them, subsequently conduct a clinical study larger.   "
22747|NCT02987855|"     Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and     Fibromyalgia represent progressive systemic pain conditions which often worsen over time.     They appear to be dysregulation of the central nervous system (CNS) and the autonomic system     (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and     disabilities. They are often associated with injury sites (including surgical) which produce     constant, often disabling pain and motor-sensory losses.      Treatments are often ineffective and include medications (often high dose opiates), Physical     Therapy (PT), and surgical interventions (sympathectomy, ablation) or insertion stimulators     of the CNS.      Study is an interventional study to document the safety and efficacy of use of     adipose-derived cellular stromal vascular fraction (AD-cSVF) in chronic pain and dysfunction     disease groups.   "
22748|NCT02987842|"     This study protocol proposes an EEG based neurofeedback (EEG-NFB) technique to upregulate the     posterior cingulate cortex (PCC) in patients suffering from mild cognitive impairment (MCI)     and early Alzheimer's disease (AD).      EEG-NFB has been successfully used as a clinical tool for over 40 years. It is based on     electrical activity measured near the surface of the brain using EEG and fed back to the     patient within half a second.      MCI is a clinical condition considered as a precursor of AD. NFB appears to be a promising     approach to treat MCI, since it has been shown to be able to induce changes in brain     plasticity. This research focuses on the PCC, which has been reported to be implicated in     MCI, and due to its location (proximity to the surface) accessible by means of EEG- NFB.      A preliminary research in MCI patients, conducted at our lab showed the lower the memory     score was at the beginning of the training, the better a subject managed to improve later on.     The investigators therefore presume that patients with early Alzheimer's disease, whose     cognitive ability is more affected compared to MCI, may benefit from EEG-NFB as well, and     maybe to a larger extent compared to MCI.   "
22749|NCT02987829|"     This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which     eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will     receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose     escalation) and part 2 (dose expansion).   "
22750|NCT02987816|"     Recent changes in medical training environments and restrictive work-hour regulations have     greatly impacted trainees, limiting the number of opportunities to gain proficiency in     procedural skills. Reports suggest that medical residents lack confidence in their ability to     perform certain medical procedures, and program directors often do not believe their     residents can operate independently in major procedures. Simulator based task training (SBTT)     has provided a safe and ethically appropriate method of skill acquisition but training     opportunities remain limited. Methods to enhance motor learning during these training     opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an     emerging form of non-invasive brain stimulation that has been shown to improve motor     learning. tDCS has been shown to enhance increasingly complex skill acquisition. The     investigators propose to examine if tDCS can improve the acquisition and retention of     neurosurgical skill. The investigators propose a double blind, sham-controlled randomized     trial applying tDCS during evidence-based SBTT of medical students, to determine if brain     stimulation can enhance training skill acquisition and retention. Even a modest enhancement     carries the potential to transform medicosurgical skills training.   "
22751|NCT02987803|"     The investigators aim to conduct a randomized controlled trial of women who are pregnant or     considering pregnancy to understand whether women provided with specific data on     hospital-level cesarean delivery rates are more likely to select higher quality hospitals,     defined as hospitals with cesarean delivery rates below the Federal HealthyPeople 2020 target     of 23.9%.   "
22752|NCT02987790|"     The judicious use of antibiotics is one of the main measures to limit the emergence of     multidrug-resistant pathogen related to excessive antimicrobial use. A recent study     demonstrated that C-reactive protein (CRP) was as useful as procalcitonin (PCT) in reducing     the time of antibiotic therapy in adult septic patients treated in the ICU setting.     Therefore, the present study proposes to compare the time of use of antimicrobials, costs of     hospitalization and clinical outcomes of interest among a group of antibiotic therapy guided     by serum levels of CRP and a group of therapy based on the best practices of antibiotic     therapy (Best Practice).   "
22753|NCT02987777|"     The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs and     to investigate its correlation impact with progression-free survival (PFS), and     clinicopathological features including microsatellite instability and quantified stromal and     intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)   "
22754|NCT02987764|"     Premature birth is a major risk factor for perinatal brain damage and cerebral palsy (CP)     with 47% of all CP cases occurring in infants with birth weight less than 2500 g. CP has     life-long neurological consequences that affect quality of life for the patient. In the last     2 decades, improvements in neonatal intensive care have improved survival of VLBW infants     significantly. This increased survival of VLBW infants poses new challenges towards     developing novel treatments and interventions to decrease neurodevelopmental impairment and     CP. While it is common for extremely preterm infant to survive at 23 weeks of gestation, the     neurologic consequences range from learning difficulties and cognitive defects to severe     disability and cerebral palsy. Currently prenatal neuroprotective agents such as     corticosteroids are utilized whenever a preterm birth is anticipated. However, there are no     proven postnatal interventions to prevent brain damage and cerebral palsy in VLBW infants.      Many recent studies show that delaying umbilical cord clamping (DCC) may improve hemodynamic     stability and decrease intraventricular hemorrhage (IVH) in preterm infants. A decrease in     incidence of IVH has a conceivable prospective benefit of decreasing brain injury and     improving long-term outcomes. Based on these findings, the American College of Obstetricians     and Gynecologist and American Academy of Pediatrics endorse that DCC may benefit the preterm     infants. However, these recommendations have not been adopted by most obstetricians in USA.     The main concern regarding the practice of DCC is the care delay in initiating resuscitation     and providing the needed care to this vulnerable population.      Therefore, as an alternative to DCC, method of cord milking (CM) has been developed to     provide cord blood transfusion to premature infants. CM offers a more practical alternative     to delayed cord clamping that may provide the same benefits without the need to delay     resuscitation. However, there are very few studies of CM in VLBW infants and there is no     evidence demonstrating long-term neurological outcomes and CP after CM.      The investigators hypothesize that cord milking in VLBW infants will result in improving     cerebral oxygenation, function and result in improved long-term neurodevelopmental outcomes     at 2 years of post-menstrual age. Premature infants born at less than or equal to 32 weeks     gestation age will receive cord milking after cutting versus standard care of immediate cord     clamping.   "
23032|NCT02984137|"     This is a prospective cohort study to evaluate degenerative changes in the brain by     performing functional imaging analysis in patients with RBD and its correlations with     clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes     with functional imaging measures and olfactory and other premotor symptoms of Lewy body     disease. This study also collects gene extracts and sera to develop a biomarker for early     detection of neurodegeneration.   "
22755|NCT02987751|"     This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal     Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2     Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The     primary outcome measures will be to compare the change in HbA1c from baseline to week 24     between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin     naïve patients with T2DM. The secondary outcomes is to compare the following in the two arms     between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point     self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%,     Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight,     BMI and Blood pressure.   "
22756|NCT02987738|"     Dapagliflozin has a unique mechanism of action that does not directly affect either insulin     resistance or insulin secretion, but rather improves glycemia by reduction of glucose     re-absorption from proximal renal tubules. Dapagliflozin is expected to reduce mean daily     glucose, improve glycemic control and reduce overall insulin requirements. Improved glycemic     control with reduced variability may also lead to reduced frequency of hypoglycemia.      In youth with T1D, Dapagliflozin led to a significant reduction of insulin needed to achieve     target glucose irrespective of preexisting HbA1c levels.      In this pilot study data will be collected to investigate the effect on glucose of two doses     of 10mg (each) dapagliflozin within range for the ensuing 24 hours during the DreaMed     automated insulin delivery in patients with type 1 diabetes dosing with dapagliflozin in an     in-patient setting combined with an automated sensor based CE marked insulin delivery system     to data if dapagliflozin is a suitable add-on therapy. This will provide optimal monitoring     of subject safety and assessment of the effects of dapagliflozin in a structured setting.      If this inpatient study shows evidence that Dapagliflozin is a suitable add on therapy and     leads to an increase of time within the target glucose range when using a sensor based     insulin pump therapy (closed-loop) further outpatient studies are planned to be conducted.   "
22757|NCT02987725|"     The purpose of this study is to test the effects of a laboratory-based hypnosis session on     peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents     (ages 12-18) with sickle cell disease and healthy controls, and examine how perceived     disease-related stigma may affect these responses.   "
22758|NCT02987712|"     Recently it has been acknowledged that cirrhotic patients present with rebalanced     hemostasis that results from decreased levels of both pro-coagulant and anti-coagulant     factors, that is not well reflected by conventional coagulation tests (CCTs).     Thromboelastography (TEG) might be a more accurate tool in these patients.      Numerous guidelines on the management of the cirrhotic patient undergoing invasive procedures     have been published but most of them are not evidence based. Current literature, although     conflicting, is leaning towards a restrictive approach to prophylactic correction of     coagulopathy when performing invasive procedures in cirrhotic patients. The investigators     suspect that common practice is more liberal . Considering the well-known adverse effects of     blood product administration, the aim of the study is to re-evaluate the clinical management     of cirrhotic patients undergoing invasive procedures.      Study objectives: asserting whether the use of blood products prior to invasive procedures in     cirrhotic coagulopathic patients can be reduced using TEG to evaluate coagulopathy in place     of CCTs, evaluating the rate of complications due to blood product use, and checking how well     CCT results correlate with TEG results in these patients.      This will be a prospective pre/post TEG protocol implementation study which will include two     prospective surveys with a 1:1 ratio. Survey 1: prophylactic administration of FFP/PLT prior     to minor invasive procedures will be based on CCTs and physicians' clinical judgement. Survey     2: management will be based on a new TEG protocol. The investigators will include cirrhotic     patients with coagulopathy who are candidates for an invasive procedure. Subject will be     provided with sufficient time to reach a rational, informed decision regarding participation     in the study.      Data will be collected from the computer based medical record systems, the patient file and     directly from the caring physician and will include a thorough medical history and     conventional blood tests, including a TEG test. All subjects will be managed according to     standard of care.      Primary endpoint: amount of blood product (fresh frozen plasma/platelets) units transfused in     preparation for the invasive procedures.      Secondary endpoints: bleeding complications, transfusion related side effects, 90 day     survival and other complications.      This will be a prospective (pre/post) study. The calculated sample size needed is 120     subjects, 60 in each group.   "
22759|NCT02987699|"     The purpose of this phase II study is to determine the recommended dose, as well as the     safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by     hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular     carcinoma (HCC).   "
22760|NCT02987686|"     Corneal melt is a complication that could affect very ill eyes and lead to the thinning of     the cornea (the clear window covering of the eyes). This thinning can lead to severe     consequences such as the leakage of the liquid inside the eye (ocular perforation), or even     blindness. Corneal melt can be caused by certain infections or as a sterile process. This     project only includes patients with a sterile corneal melt (without an infection) caused by     diseases such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens     Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.      Infliximab is an antibody against tumour necrosis factor alpha and has been used to treat or     prevent corneal melt in certain patients with inflammatory of auto-immune disease. In this     situation, infliximab was used intravenous (using veins) in order to treat the whole body.      This study's hypothesis is that infliximab can safely be used as eye drops for the treatment     of sterile corneal melt.   "
22761|NCT02987673|"     Background While several articles have reported about the effects of laparoscopic sleeve     gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has     discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is     expected to be the first randomized trial exploring and comparing these two interventions.      Setting Federico II University Hospital, Naples - ITALY.      Methods Fifty morbid obese patients are going to be studied. All patients presenting with a     normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or     MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and     esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and     24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or     MGB/OAGB.      Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2     patients determining a possible increase in gastroesophageal acid or non acid reflux?     Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual     LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or     both the procedures, is this to be primarily related to surgery per se or to weight loss?   "
22762|NCT02987660|"     The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis     (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for     the treatment of myopia with astigmatism.   "
28025|NCT02919059|"     This superiority of central pressure versus peripheral measures to predict cardiovascular     events has also been reported in general population or in elder people   "
22764|NCT02987634|"     Izun Pharmaceuticals has shown that PeriActive, an oral rinse containing extracts of Sambucus     nigra, Echinacea purpurea, and Centella asiatica significantly reduced gingival inflammation     in an experimental gingivitis model in a phase II study, as well as in numerous other     clinical trials. The product and its individual components were shown to be safe.      Based on these favorable results, Izun is now seeking to demonstrate that a combined     anti-bacterial/anti-inflammatory rinse will potentially enhance soft tissue healing and     reduce localized inflammation following dental implant surgery equal to, or better than, a     chlorhexidine rinse, with fewer side effects.   "
22765|NCT02987621|"     In this project the investigators will be using non-invasive brain stimulation on people with     multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be     recruited. One group will perform strength testing with and without the brain stimulation.     After completing the strength testing the participants will walk for six minutes to see if     any increases in strength translate into improve mobility. The second group of participants     will perform a fatigue task, pulling against a wire at a low level of force, with and without     the brain stimulation. This type of brain stimulation has been shown to transiently improve     strength and fatigue measures in other populations, e.g. aged, Parkinson's, and improve     cognitive abilities in people with multiple sclerosis. It is the investigator's hope that the     increases in performance seen in other patient groups will also occur in people with multiple     sclerosis. Future investigations will look to apply the non-invasive brain stimulation     technique during physical rehabilitation to improve short and long term outcomes related to     physical function.   "
22766|NCT02987608|"     There is an increasing demand for digital tools to empower young people with mental health     difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are     increasingly being used to support child mental health. Evidence suggests that young people     want to be active participants in their care and involved in decisions about their treatment.     However, there is a lack of digital shared decision making tools available to support young     people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop     Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to     participate more in decisions around their care.      The project will involve two phases:        -  Development Phase -Developing Power Up according to the views and ideas expressed by          young people, their parents/ carers, and clinicians in Patient and Public Involvement          (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS,          10 parents/ carers and 10 clinicians to review the acceptability of the content and          format of Power Up.        -  Feasibility testing Phase -Conducting a feasibility trial with 120 young people with          emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will          receive treatment as usual and 60 will use Power Up alongside treatment as usual.          Participant's ratings of empowerment, activation, and symptoms will be measured soon          after their referral to the service. The same measures plus shared decision making          questionnaires will be administered three months later.      The findings will inform the planning of a prospective cluster controlled trial. More broadly     this trial will contribute an understanding of the feasibility and acceptability of     developing and implementing a shared decision making app into CAMHS.   "
22767|NCT02987595|"     Diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular     disease and certain cancers. Studies have shown that diets with high whole-grain content     could decrease the risk of these lifestyle related diseases and in Sweden the national     dietary guidelines recommends whole-grain based instead of refined cereal products. It is,     however, not clear whether whole-grain from wheat and rye share similar protective effects     since there are large differences in amount and quality of dietary fibre and associated     bioactive compounds. The aim of this study is to evaluate the impact of a wholegrain diet     with low- or high lignan content on different cardiometabolic risk factors with the primary     endpoint being blood glucose levels after 2h oral glucose tolerance test in men with     metabolic syndrome or sign thereof.   "
22768|NCT02987582|"     Living with symptoms of mental illness is associated with psychosocial impairment as it can     affect someone's ability to work, their relationships and level of functioning. This also has     high economic costs on a societal level. It has been shown that an increase in     self-compassion may result in a secondary benefit of reducing psychological distress, which     could offer substantial benefits. There is little empirical data on Emotion Focused     Mindfulness (EFM) interventions for the population we are studying. This study aims to     address this gap in the literature and practice, thus advancing the field.   "
22769|NCT02987569|"     12 month study testing mobile delivery of health information and connections to professionals     and peers to improve health of teen/young adult HPN users.   "
22770|NCT02987556|"     The study will be conducted in crossover trial, with two 12-weeks periods separated by a     Wash-out period of at least one month. According to randomization ,patients will be provided     with either Diabeloop system or the usual system.      Patients will be trained for the use of blood glucose meter, of external Insulin Pump and     Diabeloop system.      In both treatment periods, the same blood glucose meter will be used throughout the duration     of the study.      In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be     performed during four weeks to improve the efficacy of Diabeloop system with data collection,     to test the manual settings by health care providers and patients and to check the     good-working of the follow-up platform.   "
22771|NCT02987543|"     The purpose of this study is to evaluate the efficacy and safety of olaparib versus     enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate     cancer who have failed prior treatment with a new hormonal agent and have homologous     recombination repair gene mutations.   "
22772|NCT02987530|"     The purpose of this study is to compare the impact of two combination of two tablets once     daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat     associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients     with primary HIV-1 infection.   "
22795|NCT02987231|"     The objective of this study is to evaluate clinically and through the concentration of     inflammatory markers, the results of 6 months of electrical stimulation associated with     coronally advanced flap for treatment of gingival recession.   "
23030|NCT02984163|"     The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is     to evaluate the relative benefit from, and implementation of an Alberta wide     clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise     (ACE) Program. The investigators hypothesize that the strategy will improve the physical     well-being and QoL of survivors (on and off cancer treatment) while preventing the     development of secondary cancers.   "
23033|NCT02984124|"     This multicenter RCT of 180 hospitalized patients and their family members evaluates an     informed assent approach to discussing cardiopulmonary resuscitation, compared to usual     care, in older seriously ill hospitalized patients with severe life-limiting illness or     severe functional impairment.   "
22773|NCT02987517|"     This study will use a comparative effectiveness design of two interventions known to reduce     running impacts. The study will be conducted at the Spaulding National Running Center. A     total of 40 male and female participants, between ages 18-50 years, running 10- 30 miles per     week will be recruited from the local running community. All potential subjects will be     cleared for physical activity using a Physical Activity Readiness Questionnaire (PAR-Q) and     screened via high-speed video to determine their habitual footstrike pattern. Those who are     rearfoot strikers will be included and will then be randomized to either an increased cadence     (CAD) or a forefoot strike (FFS) intervention group. Standardized running shoes will be     provided to both groups for the duration of the study. All participants will attend 2     strength-training instruction sessions with a physical therapist prior to gait-retraining     intervention. They will be instructed to perform the learned exercises daily for 4 weeks to     prepare the body tissues for forces associated with new gait methods. Subjects will then     attend 8 gait-retraining sessions over 2-3 weeks. Sessions will be scheduled as two     sequential days of training followed by a day of rest. The gait retraining protocols will be     conducted on a treadmill. 3D Motion Capture analysis will be conducted at baseline and at 3     points following intervention (1 week, 1 month, and 6 months).   "
22774|NCT02987504|"     This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV)     samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability,     PK/pharmacodynamic parameters, and efficacy in patients with advanced solid tumors.   "
22775|NCT02987491|"     Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic     exercise can increase insulin sensitivity in the few hours following exercise, however the     cellular mechanisms are not completely understood. The current project is to investigate     mechanisms of exercise improvements to skeletal muscle insulin sensitivity.   "
22776|NCT02987478|"     All patients will undergo in vitro fertilization.      Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.      Whole blood specimens will be collected in serum separator tubes using acceptable medical     techniques to avoid hemolysis.      Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.      clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound     performed 4-5 weeks after embryo transfer.   "
22777|NCT02987465|"     In people diagnosed with chronic kidney disease (CKD) anaemia is a common problem and is     often treated with EPO (Erythropoietin). One form of EPO used is Darbepoetin (Aranesp®). EPO     is safe to use but it has been associated with a rise in blood pressure (BP) in some     individuals. The reasons for this are not clear. To try to explain this, this study will look     at how EPO affects certain substances in the blood that influence how blood vessels contract     and relax. This will be conducted by infusing small amounts of Acetylcholine, BQ123 and     Noradrenaline into the arm vessels of volunteers using an established method called Forearm     blood flow (plethysmography). Volunteers recruited for this study will include CKD patients     undergoing therapy with Darbepoetin as part of their normal NHS care as well as healthy     people not on treatment, who will act as controls. This is an observational pilot study of     changes in physiology before and after Darbepoetin. It will provide valuable data for a later     study comparing Darbepoetin to novel agents which work via different pathways to treat     anaemia.   "
22778|NCT02987452|"     Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure     (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic     parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive     (RHTN) patients, have not been investigated yet.   "
22779|NCT02987439|"     Purpose: In a randomized controlled trial we will assess the effect of early pulmonary     rehabilitation in patient with an acute exacerbation of chronic obstructive lung disease     (AECOPD).   "
22780|NCT02987426|"     Mindfulness-based interventions have gained increasing popularity in recent years as     effective treatment for mental illness. Mindfulness is defined as paying attention in a     particular way: on purpose, in the present moment, and non-judgmentally: Being, rather than     Doing. Such mental states can improve emotional regulation through frontal cortex     inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal mindfulness     approaches such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress     reduction, have been highly effective in a broad range of psychiatric disorders.      Mindfulness-oriented interventions, are potentially useful in acute psychiatric     hospitalizations, since they can be delivered as group therapies and are be both     cost-effective and scalable. However, such interventions have rarely been provided to     patients during psychiatric hospitalizations, where patients are treated for a variety of     psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had     been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent     meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients     with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly,     MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar     disorder, severe anxiety, substance use disorders, and major depressive disorder.      Few studies have examined mindfulness-oriented treatments in inpatient settings, including     two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n<10)     . Another study (n=23) offered inpatients with a diagnosis of major depressive disorder     mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in     inpatient settings were feasible, although these needed to be brief interventions, given the     risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental     illness.      A cross-sectional study conducted by our team (n=40) demonstrated that brief group     mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric     inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no     symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported     improvements in general well-being and mood after a single 10-minute session. Having been     recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75%     of inpatients) did not affect patients' capacity to tolerate and benefit from the     intervention. In this inpatient psychiatric population, we found that mindfulness-oriented     interventions that were brief and involved physical movement (e.g. seated Tai Chi) were     better enjoyed compared to other interventions.      Despite the growing literature in this field, data is needed on the effectiveness and health     service implications of brief group mindfulness-oriented interventions in inpatient     psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to     methodological flaws, including inadequate control groups, very small sample sizes (often     n<10), and lack of randomization. In Canada, the direct cost of treatment for mental illness     is estimated as 42.3 billion. Much of these costs are driven by psychiatric admissions. Thus,     if brief mindfulness-oriented interventions are effective at lowering psychiatric symptom     severity and shortening psychiatric hospitalizations, this could lead to significant     cost-savings.   "
22781|NCT02987413|"     Background: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that     selectively affects motor neurons in the brain and spinal cord, leading to bulbar,     respiratory, and limb weakness. There is no effective treatment, and the disease usually     progresses to death within 2 to 4 years. The therapeutic plasticity of mesenchymal stem cells     (MSCs) may be an attractive therapy to this complex disease, turning MSCs strong candidates     for cellular therapy in ALS.      Design—A phase 1 open-safety clinical trial. 4 patients will be selected according to a     restricted inclusion and exclusion criteria and after 2 escalated infusions of MSCs, there     will be a follow up period of one year Methods - Primary endpoint: safety of mesenchymal     autologous stem cells infusions escalated in two intrathecal administrations in patients with     ALS defined as severe adverse events (SAe). Secondary endpoints: clinical response,     laboratorial and magnetic resonance imaging of patients submitted to cellular escalating     doses applied in the study. Quality of life, according to El Escorial criteria, ALSFR scale     and functional scales.      Conclusion: This study is a primary step before a large randomized double-blind clinical     trial for ALS. It is expected to confirm the safety of escalated MSCs therapy in ALS     patients, initial data of efficacy in addition to improved quality of life.   "
22782|NCT02987400|"     The purpose of this study is to evaluate the clinical activity and tolerability of a     combination of obinutuzumab plus venetoclax in patients with relapsed or refractory diffuse     large B-cell lymphoma.   "
22783|NCT02987387|"     This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT     Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular     outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market     setting.   "
22784|NCT02987374|"     The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in     healthy young adults by vaccinating participants and obtaining blood samples at designated     time points before and after vaccination.   "
22785|NCT02987361|"     The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve     upper limb motor recovery in the sub-acute phase of stroke patients.      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.   "
22883|NCT02986074|"     The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant     based on anatomical landmarks with standard surgical implantation technique.   "
23034|NCT02984111|"     The aim of this trail is to assess the safety and therapeutic effects of single EPO     intervention in different times during coronary surgery in changes of inflammatory response.   "
22786|NCT02987348|"     This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD)     database analysis to compare therapy effectiveness, and cost between exenatide and basal     insulin in patients with type 2 diabetes.      Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels     (hyperglycaemia) that can result in an increased risk of a variety of conditions including     heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients     may control their blood sugar by lifestyle modification (diet and exercise), ultimately most     will require therapeutic intervention with regimens that increase in complexity as T2DM     progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to     weight loss as well as improved blood glucose control. It has also been associated with     reduced heart attacks and strokes. In this study CPRD database will be used to compare     outcomes for patients prescribed exenatide compared with those prescribed insulin; a more     established treatment for T2DM. In particular changes from baseline in blood sugar control     and weight will be considered as the primary outcomes. As the choice to treat with exenatide     or insulin will be related to patient characteristics which may in themselves be associated     with the outcomes of the study we aim to match study patients on some of these key variables     and adjust for others in our analysis.   "
22787|NCT02987335|"     India has the world's highest prevalence of diabetes, expected to rise to 80 million by 2030.     This includes many patients with lean diabetes, with low body mass index (BMI) and severe     complications of diabetes. Despite its prevalence in India and other countries and its dire     health consequences to individuals with the disease, little is known about the     aetiopathogenesis and the genotype-phenotype relationship, lean diabetes being a cluster of     low birth weight individuals, MODY, lipododystrophic disease, type 1 diabetes and     fibrocalcific disease. While rudimentary tests have suggested defects in both insulin     secretion and action, no comprehensive metabolic studies have been performed. It is therefore     unclear as to how these patients should be treated. The optimal therapeutic adjunct whether a     suitable oralantidiabetic agent or insulin is not yet determined. Defining the metabolic     defects of 'lean' diabetes should have tremendous therapeutic benefit for millions of     patients with this elusive condition.   "
22788|NCT02987322|"     Background: Honey, as a natural product produced by honey bees, has anti-oxidant,     anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that     honey might have positive effects on cardiovascular diseases.      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2     to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly     assigned into two equal groups: the honey group and the control group. In the honey group,     honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional     treatment of IDC. The patients in the control group received only their standard treatment,     without honey. The main outcome measure was the percent change in the ejection fraction (EF)     and the fraction shortening (FS) shown in echocardiography.   "
22789|NCT02987309|"     Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical     status. There is however poor correlation between these calculations and actual energy     consumption measured with indirect calorimetry (IC). Available equipment for IC has however     been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated     in modern ventilators. This functionality is easy to use, but we do not know if the results     are reliable for children. This study is a method comparison study comparing measurements     done with SensorMedics Vmax (gold standard) vs GE Carescape (modern ventilator with     Integrated IC) in children undergoing intensive care treatment.   "
22790|NCT02987296|"     The immune system plays an important role in helping to kill and prevent cancers. Cells of     the immune system, such as natural killer (NK) cells and T cells, do not work as well     following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the     body. Surgery has shown to cause a reduction of arginine in the body. In turn, this     deficiency causes NK cell suppression. In this study, we want to look at the effects of     arginine supplementation before and after surgery on NK cell function in surgery patients. In     this study, we will be using a nutritional supplement containing arginine and a placebo drink     (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer patients 5     days before surgery and 5 days after surgery. Using patient blood samples, we will measure NK     cell levels, arginine levels and also arginase activity.   "
22791|NCT02987283|"     The investigators will perform a diagnostic accuracy study comparing tracheal breath sound     recordings in awake individuals to the STOP-Bang screening questionnaire, using the     apnea-hypopnea index (AHI) score determined by polysomnography as the gold standard.   "
22792|NCT02987270|"     This study is a cluster-randomized controlled trial to evaluate the efficacy of     community-based mass screening with a malaria rapid diagnostic test, and treatment of     participants with positive tests with an appropriate antimalarial for reducing malaria     transmission indices.   "
22793|NCT02987257|"     Defining the true effect of adjunctive therapy for Stevens-Johnson Syndrome and Toxic     Epidermal Necrolysis (SJS/TEN) on time to full healing, mortality, and long-term outcomes     represents a critical need in the field of dermatology and burn surgery. Collaborating with     20 sites from across North America we will determine if cyclosporine or etanercept therapy     improves SJS/TEN short outcomes above supportive care alone The scientific premise for this     study is that case series, cohorts, and small non-randomized studies have not supported the     use of non-pulsed corticosteroids and intravenous immunoglobulin (IVIG), while showing the     promise of cyclosporine and etanercept in reducing the time to complete re-epithelialization.     By indirect comparison, etanercept appears to be superior in small studies, however none of     the studies have evaluated these therapies in a blinded and randomized trial. Additionally,     we will uncover the underlying process of SJS/TEN through the analysis of skin samples,     blood, blister fluid and immune cells to study the immune system and changes in gene     expression with and without drug therapy. This will improve the treatment of patients in the     future.   "
22794|NCT02987244|"     The purpose of this study is to determine determine the maximum tolerated dose (MTD) and     safety of the combination of Chidamide combined with CHOEP(cyclophosphamide，     epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in     newly-diagnosed T-NHL.   "
23031|NCT02984150|"     This study aim to investigate the influence of intragastrically infused fatty acid on the     generalization of responses to reward within the food domain and between financial and sexual     domains.   "
22796|NCT02987218|"     Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by the rupture of an intracranial     aneurysm and accumulation of blood in the subarachnoid space with 30 to 40% mortality rate.     Amongst the survivors 40-50% suffers disability due to cognitive decline.Trends towards early     surgery offers challenge to anesthesiologist to provide optimum brain relaxation and     simultaneously maintaining stable hemodynamics. Anesthetic agents are administered to conduct     smooth neurosurgical procedure. These agents may affect patient's cognitive function     postoperatively.Currently most common anesthetic agents used are either intravenous hypnotic     agents (propofol) or volatile inhalational agents (isoflurane/sevoflurane/desflurane).     Provision of neuroprotection with propofol and volatile inhalational agents has been studied     by various authors.Not many studies have been performed in patients undergoing aneurysmal     clipping surgeries looking into effects of various anesthetic agents on intraoperative (I/O)     brain condition, I/O hemodynamic and POCD.Thus present study is planned to compare propofol     and desflurane for long term postoperative cognitive decline in patients undergoing surgery     following aneurysmal subarachnoid hemorrhage.   "
22797|NCT02987205|"     A randomized, multicenter, double blind, split-face study in subjects seeking NLF correction.     Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Restylane     in the NLF on the other side of the face. The side of the face for each product was randomly     assigned. The investigator performing the evaluations and the subject were blinded to the     treatment; injections of the study product were performed by an unblinded injecting     investigator.   "
22798|NCT02987192|"     Spinal canal anesthesia is marked the most commonly used method of cesarean section.     Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty     of parturients are undergoing anticoagulation therapy.They may be forced to accept general     anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive     spinal anesthesia.   "
22799|NCT02987179|"     The clinical diagnosis of sleep apnea is difficult among ESRD patients since the     characteristic clinical features of sleep apnea may be absent and since sleep-related     symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the     evaluation of patients with possible sleep apnea is the same among ESRD patients as in the     general population.   "
22800|NCT02987166|"     This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT)     administered in combination with pembrolizumab in patients with solid tumors.   "
22801|NCT02987153|"     Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a     single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or     potentially unstable spinal cord metastases. The primary objective is to evaluate the     response rate of pain control when combining kyphoplasty, a minimally invasive procedure,     with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord     metastases. Secondary objectives are (i.) to determine feasibility for unstable or potential     unstable spine metastases; (ii.) to determine tolerability/side effects of the IORT within 90     days post-procedure; (iii.) to determine which clinical factors are prognostic of vertebral     compression fracture   "
22802|NCT02987140|"     The overall goals of this proposed study are to investigate the behavioral and     neurophysiological mechanisms of patients with Parkinson's disease (PD) experiencing freezing     of gait (FoG). More specifically, we aim to determine the behavioral changes in     context-dependency and changes in corticomotor excitability associated with FoG.   "
22803|NCT02987127|"     Gastric low-grade mucosa-associated lymphoid tissue lymphoma (MALToma) is associated with     Helicobacter pylori (HP) infection, and around 70% of these tumors can be cured by HP     eradication therapy (HPE). However, the role of antibiotics in the frontline treatment of     extragastric MALToma remains unclear. In addition to anecdotal case reports showing     histologic regression of extragastric MALTomas after antibiotics, our explorative study found     that frontline HPE (clarithromycin, amoxicillin, and omeprazole) resulted in complete     remission (CR) in this subgroup patients (2 salivary gland, 1 lung, 1 colon, and 4 ocular     adnexal MALToma [OAML]). Interestingly, two patients with OAML who do not respond to     Chlamydia psittaci (CP) eradication using doxycycline achieved CR after HPE. These findings     suggest that bacterial infections, including HP, may be involved in the lymphomagenesis of     these extragastric MALTomas. Our preliminary results also revealed that 5 (23.8%) of 21     HP-negative gastric MALToma patients achieved CR after HPE, indicating that antibiotics may     also have ability to eradicate non-HP bacteria. Based on our preliminary findings and the     indolent biologic behavior of MALToma, it is reasonable to use frontline HPE in the treatment     of early-stage low-grade extragastric MALToma.   "
22804|NCT02987114|"     Open-label,clinical study to evaluate the safety, tolerability and efficacy of oral     administration of PTL101 (cannabidiol) for the treatment for pediatric intractable epilepsy.      Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow     up.   "
22805|NCT02987101|"     Chronic leg ulcers are associated with decreased quality of life and an increased mortality.     In many cases these ulcers are treated conservatively and the healing time can be several     months. In this open randomized clinical trial we will examine if we can accelerate wound     healing when using autologous stromal vascular fraction as an adjunct to standard wound care.   "
22806|NCT02987088|"     The purpose of this study is to determine the optimal dose of sodium nitrate administered     during resuscitation to achieve a plasma level of 10 μM by hospital arrival.      Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV     dose of sodium nitrite will achieve the optimal (based on preclinical studies)     neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100     patients, we will determine whether 25 mg IV administered during resuscitation will achieve     plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either     decreasing or increasing, will be made if necessary permitting us to determine the optimal     nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected   "
22807|NCT02987075|"     A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo     transfer at 66±2 hours after ICSI using single step culture medium   "
22884|NCT02986061|"     The aim of this study was to investigate whether urinary catheterization could be avoided for     all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus     multi-site infiltration analgesia.   "
22808|NCT02987062|"     According to current guidelines for non-valvular atrial fibrillation treatment, the first     line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K     antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval     trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on     real-life clinical practice.      The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs)     in an academic and district hospital, with regard to inclusion/exclusion criteria used in the     clinical trials.   "
22809|NCT02987049|"     The purpose of this study is to fill in the gaps in knowledge on the tolerability and     effectiveness of an outpatient, Pritikin-based Intensive Cardiac Rehabilitation (ICR) program     on traditional cardiovascular risk factors, exercise performance, and patient well-being (as     assessed by questionnaires), as well as to monitor subsequent clinical events. The hypothesis     is that patients in the Intensive Cardiac Rehabilitation (ICR) group will have greater     improvements in several cardiovascular disease risk factors than patients in the conventional     Cardiac Rehabilitation (CR) group at the end of 24 sessions.   "
22810|NCT02987036|"     The purpose of this study is to find out weather differences in administration nebulizer     technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables     (Compliance, resistance and PEEPi) during controlled mechanical ventilation.   "
22811|NCT02987023|"     The study is a follow up of NCT01844362. Uterus transplantation will be performed from live     donors to patients with uterine factor infertility. If will be performed before     transplantation. Organ procurement from the donor will be performed by robotic assisted     laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months     after transplantation. After birth of 1-3 children the uterus will be removed by     hysterectomy,   "
22812|NCT02987010|"     Cohort A - neoadjuvant administration of IDH305 at 550 mg BID for 6 weeks followed by     surgical resection at 6 weeks. If there is no evidence of progressive disease at 6 weeks     (clinical, radiographic or histopathologic exam), the patient will continue on IDH305 at 550     mg BID post-operatively for a maximum of 11 additional 28 day cycles. Subsequent assessment     of disease will occur every 2 months starting in Cycle 2.      Cohort B - patients who have inoperable tumors but measurable 2HG pre-treatment will be     treated with IDH305 at 550 mg BID x 6 weeks. If there is adequate sustained knockdown of 2HG     on MRS and disease is stable or improved, then the patient will continue on treatment for a     maximum of 11 additional 28 day cycles.   "
22813|NCT02986997|"     Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged:     it begins in the lithotomy position for ureteral catheter placement and retrograde     pyelography and, subsequently, an optimal renal access is obtained in the prone position. In     most of the centers, the PNL is done under general anesthesia (GA) that is associated with a     risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a     prone position. In our Department the procedure is usually performed under epidural     anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL     over the last decade in the Medical University of Warsaw Urology Department   "
22814|NCT02986984|"     This is a prospective, observational, cohort study of patients with a clinical diagnosis of     diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect,     process, and study kidney tissue and to harvest blood, urine and genetic materials to     elucidate molecular pathways and link them to biomarkers that characterize those patients     have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser     degrees of kidney function change over the period of observation. High through-put genomic     analysis associated with genetic and biomarker testing will serve to identify key potential     therapeutic targets for DKD by comparing patients with rapid and slow progression patterns.     Each participating clinical site will search for, consent, harvest the biopsy sample, and     enroll the participants as required for the TRIDENT protocol.   "
22815|NCT02986971|"     There are no implant removal devices on the market by any manufacturer. New features are     described in comparison with the existing removal technique. Overall, the RemovAid™ combines     the features of fixation, incision and extraction. This combination of functions has not     previously been combined in a single device.      The investigators wish to perform this pilot clinical investigation with the aim to     demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and     effectively facilitate implant removal. Other aims are to show that the IMD have the     potential to reduce procedure length variability, reduce procedural complexity and reduce the     need for additional procedural equipment related to CI removal procedures, without causing     any harm to the subject.   "
22816|NCT02986958|"     This study evaluates an agenda-setting checklist for patients with cognitive impairment and     their family companions that is completed in the waiting room in advance of a primary care     visit. The study team will conduct a two-group randomized trial to examine feasibility of the     protocol and to compare medical communication (from visit audiotapes) during visits of     patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who     receive usual care (n=50)   "
22817|NCT02986945|"     The purpose of the study is to test an experimental method, a text-messaging app called     B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation     of a Resiliency Course, developed by community members known as Building Resiliency and     Community Hope.   "
22818|NCT02986932|"     This is a prospective, non-randomized, single-arm, feasibility study to evaluate the safety     and initial effectiveness of opening of the Blood-Brain Barrier with intravenous contrast     agents using the ExAblate Neuro System in patients with early stage Alzheimer's Disease.   "
22819|NCT02986919|"     Establish safety and toxicity profile and preliminary response rate of CPI-0610 in MPNST     patients and correlate response with pharmacodynamics markers and BET inhibition.   "
22820|NCT02986906|"     Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy.     Although many conservative managements of UNE, the effectiveness of these methods are     unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural     injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment     for entrapment neuropathy. However, current studies have not proved the effects of PIT on     peripheral neuropathy because these studies enrolled small number of patients and lacked     controlled design. We design a randomized, double-blind, controlled trail to assess the     effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.   "
22821|NCT02986893|"     The goal of this project is to establish the feasibility of dietary research in Multiple     Sclerosis (MS) patients as well as to provide preliminary data to support future clinical     trials of diet in MS. This project is a pilot randomized trial of a dietary intervention in     MS patients. The dietary intervention was designed to include dietary components that have     been suggested to be of benefit in MS through basic science research and observational-type     studies in MS patients and to exclude those that have been suggested to be detrimental. It is     therefore rich in foods that are high in polyunsaturated fatty acids (particularly omega-3     fatty acids), foods that are high in polyphenols and antioxidant vitamins such as berries and     other fruits and vegetables, as well as whole grains, and excludes meat other than fish as     well as dairy and refined sugars and limits salt. Subjects are randomly assigned to the     dietary intervention or to the non-intervention group. The non-intervention group will be     invited to attend regular meetings with a focus on wellness in MS however will not receive     specific dietary instructions. At the end of the study those who were not in the dietary     intervention group will have the opportunity to receive all of the materials used during the     study should they wish to begin the diet.   "
22822|NCT02986880|"     The main objective of the study is to estimate the efficiency and to determine the optimal     dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after     radiotherapy, as well as the optimal sites for these injections.      The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the     splenius capitis.   "
22823|NCT02986867|"     The study is an exploratory prospective, single center study with correlative endpoints. The     study will investigate the association of tumor cGAS STING signaling with SAbR. Tumor core     biopsies will be processed and analyzed as described above. Medical records electronic     medical records will be used to collect demographic and medical information and imaging     studies.   "
22824|NCT02986854|"     The purpose/aim of this study is to assess the safety and antibody response to vaccination     with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess     the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects   "
22825|NCT02986841|"     This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements     (CDEs) in primary care settings. The study will be conducted at three adult primary care     clinics, in two large health systems. Each phase will include deliverables essential to move     to the next phase, and an independent Advisory Committee will review progress and make     recommendations at each transition about how best to progress to each subsequent phase. Based     on progress during earlier phases, the Advisory Committee may recommend expansion to     additional clinics or health systems during the second part of Phase 4.      Phase 2 prepares for implementation of the screening and CDS tools as part of routine     clinical practice. A key component of this phase is tailoring the screening and CDS tools     through an iterative process of usability testing and adaptation of their design. In the KTA     framework, this phase corresponds to the 'select, tailor, and implement interventions' step.     Simultaneously, investigators will plan for implementation in one clinic of the MSHS system     by identifying clinical champions, educating clinic leadership and staff, and conducting a     workflow analysis to identify barriers and facilitators of implementation.   "
22826|NCT02986828|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Rather than other progressive     disease, CTS is characterized by remission and recurrence. Although many conservative     managements of CTS, the effectiveness of these methods is insignificant or only persist for a     short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients     with kinds of musculoskeletal disorders and recent reports showed being beneficial for     peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the     positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However,     these studies have not entirely proved the effects of PRP on peripheral neuropathy because     these studies enrolled small number of patients and lacked controlled design. The     investigators design a randomized, double-blind, controlled trail to assess the effect after     ultrasound-guided PRP injection in patients with CTS.   "
22827|NCT02986815|"     At each point that the patient will have [11C]-Acetate PET study, this will be compared with     standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide     (chemotherapy)      Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will be     analyzed qualitatively by visual assessment, quantitatively using a standard uptake value     (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by     compartmental modeling of dynamic data.   "
22828|NCT02986802|"     Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant     death and illness, affecting 500,000 births with annual medical costs of more than $26     billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is     considered a top research priority. Recent research has shown genital herpes infection (HSV)     is associated with increased risks of PTD and LBW. More importantly, treating this infection,     including infection with no symptoms, using readily available antiviral medications can be     effective in removing the risk due to HSV. Thus, early identification and treatment of HSV in     pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant     women with HSV infection, especially those with no symptoms, choose not to treat due to (a) a     lack of demonstrated benefit of treatment and (b) general hesitance to use medications during     pregnancy due to safety concerns for the fetus. Thus, emerging evidence of an increased risk     of PTD/LBW associated with HSV infection, if untreated, and treatment effectiveness by     anti-herpes medications has significantly changed current treatment paradigms among pregnant     women. This evidence also provides new hope that effectively treating HSV infection among     pregnant women, especially before the 3rd trimester, could lead to a new method to reduce PTD     and LBW and reduce racial/ethnic disparities in these risks due to high rates of the     infection in minority groups. Thus, to further examine the effectiveness of treating HSV in     pregnant women to reduce adverse pregnancy outcomes, the investigators propose to conduct a     prospective cohort study with a two-stage design combining the large pregnant women     population (N=90,000) in Stage I identified through Kaiser Permanente Northern California     (KPNC) electronic medical records (EMRs), with a Stage II sample to collect detailed     information on additional factors that might muddle our understanding of this issue. This     study will address the following: (1) Does treating HSV infection in pregnant women reduce     the risk of PTD or LBW? (2) Does timing of the treatment during pregnancy influence treatment     effectiveness? (3) Do other factors influence treatment effectiveness? and (4) Does HSV     infection in pregnancy, if untreated, increase the risk of PTD and LBW, compared to no     infection? Answers to these questions will be valuable to pregnant women and clinicians, and     directly address their concerns when making treatment decisions   "
22885|NCT02986048|"     The purpose of this study is to establish a database (or registry) of patients treated with     proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track     of the patients treated it will allow the investigators to periodically evaluate the outcomes     of patients.   "
22829|NCT02986776|"     A prior study in a tightly controlled clinical research environment found individuals with an     alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if     they presented with high alcohol involvement and/or low cognitive functioning. This study     sought to: (a) validate and extend these findings within the uncontrolled environment of a     community-based treatment center, and (b) test whether inpatients had fewer days of     involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need     for inpatient treatment, using prior cut-points for alcohol involvement and cognitive     functioning, participants were randomly assigned within inpatient need group (No Need for IP;     Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient     treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted     an 90-day intervals across 18 months.   "
22830|NCT02986763|"     An association has been suggested with several diseases including cancer and IARC has     classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a     better characterisation of environmental pesticides exposures and identification of suitable     biomarkers of exposure and effect. A better understanding of the impact of pesticide exposure     on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen     epidemiological hypotheses on the association with several cancer types.      The main objective of the project is to validate a GIS (geographic information system) based     method to assess environmental pesticide exposures, using environmental (contamination of     housedust) and biological (blood and urine samples) measures. The project aims further to     investigate a potential link between housedust contamination and biological measures in     healthy non-smoking male residents and explore the impact of environmental pesticide exposure     on metabolomics, transcriptomic and epigenetic parameters.   "
22831|NCT02986750|"     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the     elderly population. Topically administered lubricants are the basis for treatment of this     disease. However, exact information about influence on tear film thickness and corneal     residence time of topical lubricants is still sparse, therefore no ideal treatment regimen     has been found.      Recently a new method for assessment of tear film thickness based on ultra-high resolution     optical coherence tomography (OCT) has become available. The aim of the present study is to     assess the influence on tear film thickness of three different formulations of topical     lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye     Drops in patients with moderate to severe dry eye disease. In addition, standard tests for     dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal     fluorescein staining and determination of tear break up time (BUT) will be performed to     compare the product effects.   "
22832|NCT02986737|"     Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP     Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety     and performance of the study device   "
22833|NCT02986724|"     The purpose of this non-interventional study (NIS) study is to assess further knowledge on     the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in     participants with CD and UC naive to biologics.   "
22834|NCT02986711|"     This study aims to pilot a method of collecting the post-discharge follow-up data required by     the Joint Commission Tobacco Measure Set, using text messages sent to and received from     patients' cellular-telephones. It also aims to assess whether specially designed relapse     prevention text messages designed to encourage abstinence from smoking, can increase the     proportion of smokers who remain abstinent during the first month after discharge from     hospital.   "
22835|NCT02986698|"     The investigators aims to evaluate the safety of in utero hematopoietic stem cell     transplantation in fetuses with alpha-thalassemia major performed at the time of in utero     transfusion of red blood cells.   "
22836|NCT02986685|"     The research aims to investigate whether trimebutine maleate combined with rabeprazole can     improve the clinical efficacy in patients With refractory Los Angeles grade A or B reflux     esophagitis . A total of 500 patients with Grade A or B reflux esophagitis refractory to     rabeprazole will be randomly divided into two groups.One will continue to receive rabeprazole     treatment,and the other group will receive extra oral trimebutine maleate 200 mg three times     daily for 4 weeks. The end of the study for every patient is the improvement of main     symptoms. The primary and secondary analyses are the main symptoms score, endoscopy results,     Gastroesophageal reflux disease questionnaire（GerdQ) score,Hospital Anxiety and Depression     Scale(HADS) score, Athens insomnia scale and World Health Organization Quality of     Life-Bref(WHOQOL-BREF)scale scores at the baseline and final assessments.   "
22837|NCT02986672|"     This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty     acids on children aged from 6-13 years, with ADHD/ADD and related symptoms. The study is a     randomized, double-blind placebo-control study including approximately 330 children from     Norway. The primary outcome measure is ADHD core symptoms reported by caregivers, teachers     and the child at 0 months (baseline), 6 months (end of treatment) and 12 months (6 months     post treatment). The secondary outcome measures are reading and writing disabilities,     cognitive functions, and physical Health.   "
22838|NCT02986659|"     Medical scientists have found that people with diabetes who take the drug Metformin have less     age-related disease than those taking other treatments and researchers believe it may prevent     numerous diseases and conditions that effect older people. In addition, metformin extends     lifespan in some animal models of human disease. The purpose of this study is to see if     taking Metformin causes changes in blood cells consistent with improved health and longevity     in people who do not have diabetes. In this study Metformin will be compared to placebo. A     placebo is a substance, like a sugar pill, that is not thought to have any effect on a     participants disease or condition. In this study participants will either receive the active     study medication, Metformin or placebo which is not active. Placebos are used in research     studies to see if the drug being studied really does have an effect.   "
22886|NCT02986035|"     This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying     shoulder tendinitis in terms of:        1. Reduction or removal of shoulder calcifications        2. Functional improvements        3. Pain improvements 10 subjects will be assessed prior and 1 and 2 months post          intervention onset. The intervention will consist in the application of the ECA cream in          the affected shoulder twice a day during 1 month.   "
22839|NCT02986646|"     Lateral epicondylitis, commonly known as tennis elbow is a common cause of elbow pain     encountered in primary care and specialty clinics. Although lateral epicondylitis is common,     little consensus exists on the best way to treat it. Historically 80% of patients will get     better with non-operative treatments (rest, NSAIDS, bracing and injections). In regard to     efficacy of injections, recent large, prospective, randomized studies have shown minor     improvements in the short term, but no long term benefits when compared to saline injection.     Consistently, intra-articular injections have not been reported. The investigators suspect     that elbow joint inflammation may be an underappreciated source of pain in lateral     epicondylitis. The investigators' hypothesis is that patients receiving intra-articular     injections will have greater improvement compared to patients receiving either no injection     or an intra-tendinous injection.   "
22840|NCT02986633|"     The present observational prospective study aims at identifying echocardiographic parameters     (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV)     ascertained using new methods of echocardiography including speckle tracking strain) that are     linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT   "
22841|NCT02986620|"     This is a study where there are no interventions planned. Investigators will only collect     data already in the patient's history and analyze it. Particularly, we are interested in     molecular data from AML patients.      This means that patients will follow their regular diagnostic and clinical practice. The     analyses will be conducted according to the routine diagnostic and clinical practice as well     and no additional blood withdrawal will be performed.   "
22842|NCT02986607|"     The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal     activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the     renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality     of life. The main objective of the current study is to test if PTH deficiency influences the     secretion of corticosteroids and whether any abnormalities in the HPA-axis and the     RAAS-system can be reversed by PTH infusion.   "
22843|NCT02986594|"     In this clinical cohort study, the investigators observe the efficacy of low molecular weight     heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective     randomized controlled trial.   "
22844|NCT02986581|"     The purpose of this study is to collect data of rapid response team activated patients     prospectively   "
22845|NCT02986568|"     The purpose of this study is to compare standard treatment and fusion ontogenetic surgery     (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial     resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and     survival.   "
22846|NCT02986555|"     Current virtual reality device makes motion sickness and visual fatigue having limitation for     recreation and other clinical approaches. Still there is no standardized quantification of     motion sickness and visual fatigue measurement with objective approach. Current biofeedback     accompanied with virtual reality would be promising tool for stress relief.   "
22847|NCT02986542|"     The use of USI has eased practical application of interventional procedures, and reduced     complications and procedure durations. For vascular interventions with ultrasound imaging,     short- or long-section imaging of vascular structures is performed. Both techniques have     their own advantages and disadvantages.      This study aims to compare the success rates of femoral artery catheterization using both     imaging techniques.   "
22848|NCT02986529|"     To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after     administration of single oral doses of 900mg in healthy Male subjects.   "
22849|NCT02986516|"     Comparative study on surgery versus definitive radiation therapy in primary localized sacral     chordoma   "
22850|NCT02986503|"     The study is a first step of a process to establish the standard chemotherapy treatment with     the aim to improve outcome for patients with these rare tumours. For this reason the study     will be non-controlled clinical trial.      In this regard, the study aims to determine the feasibility of intensive chemotherapy in this     age group, and/or separate efficacy analyses according to the different histologic categories     and whether the number of patients recruited by the co-operating groups permits future     randomised studies.   "
22851|NCT02986490|"     Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia,     dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic     could be accompanied by a decrease in the concentration of serum magnesium. Low serum     concentrations of magnesium are potentially a risk factor of cardiac sudden death (Peacock,     2010). Hypotheses linking magnesium and pathogenesis of cardiovacuscular diseases are     multiple. Also, it seems to exist a close relationship between magnesium and carbohydrate     metabolism. Most studies on the subject have generally studied plasmatic magnesium.      Objective : Describe the relationship between changes in serum and intra-erythrocyte     magnesium and cardiometabolic risk in patients innitiating an antipsychotic treatment. A     secondary objective is to specify the frequency, magnitude and time to onset of changes in     plasma of magnesium levels under antipsychotic treatment.      Methods : This is a pilot single-center prospective cohort. After inclusion, patients status     (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status     will define the exposure criterion. Included patients will be followed for 1 year during     which cardiometabolic markers will be measured.      Population : patients who are more than 18 years old with schizophrenia schizoaffective     disorder or bipolar disorder, naive to antipsychotic treatment or off for more than 3 months     and requiring the introduction of antipsychotic drug therapy. Patients will be recruited     during consultations and stays in care units of Adult Psychiatry Unit of Montpellier     University Hospital.      Factor studied: serum and intra-erythrocytic magnesium levels at beginning and during the     antipsychotic treatment measured by a unique analyzer center. Changes in levels of     hypomagnesemia expected during the treatment will determine exposure groups.      Outcome: cardiometabolic risk markers measured at the beginning and during the treatment will     be fasting blood glucose, fasting plasma insulin, HOMA-IR [Ins (uU / mL) x Gly (mmol / L) /     22.5], lipid profile (total cholesterol, LDL, HDL), BMI, waist circumference and ECG (QTc).      Cofactors: age, sex, personal and family medical history, blood pressure, smoking, diet,     physical activity, psychiatric disease, Global Impressions, anti-psychotic treatment and     comedications.      Perspectives : to show that decreased in magnesium levels observed among patients starting     antipsychotic treatment is associated with deterioration of cardiometabolic risk markers. The     demonstration of this association could explain at least part the increased cardiovascular     risk observed in this population. In the longer term, the results of this study would argue     the implementation of an intervention research project studying magnesium supplementation to     minimize the metabolic effects of antipsychotic medications.   "
22897|NCT02985892|"     The incidence of chronic nonspecific low back pain is the highest in the world population and     can lead to disability. One of the standards treatments for this condition is the segmental     stabilization exercises, as well as trunk stretching. However, there is no study that     associates these two treatments for nonspecific low back pain. This study will be a     controlled clinical trial, randomized, prospective, single-blind with a quantitative approach     that compares the efficacy of the association between segmental stabilization + trunk     stretching with segmental stabilization + placebo stretching in patients with chronic     nonspecific low back pain.   "
22852|NCT02986477|"     In children, specifically the intravesicle administration to study vesicoureteral reflux in     children already catheterized and scheduled for voiding cystourethrogram (VCUG).     Contrast-enhanced ultrasonography is a tremendous advancement from conventional B-mode and     color Doppler ultrasonography, as it permits noninvasive, non-ionizing delineation of     physiology and pathophysiology with higher resolution and accuracy in children. The technique     is particularly useful in pediatric population whose lifetime risk of cancer significantly     increases with higher frequency of ionizing radiation. Voiding cystourethrogram is a     fluoroscopy technique that can study reflux real time but at the risk of radiation side     effects. In this regard, intravesicle administration of ultrasound contrast agent can help     avoid radiation in children and potentially replace the conventionally used voiding     cystourethrogram.   "
22853|NCT02986464|"     Procedural pain is the most intense and often undertreated pain associated with burn     injuries. The use of analgesics does not always provide optimal relief and is accompanied by     several side effects. Indeed, children with burn injuries still experience severe pain     intensity during procedures despite the fact that doses of analgesics used with this     population has almost doubled in the last twenty years. Current guidelines on pediatric     procedural pain management recommend the combination of non-pharmacological and     pharmacological interventions to enhance pain management and decrease the numerous side     effects of analgesics. Distraction has been identified among the most effective     non-pharmacological interventions for pain as it diverts the child's attention to an     attractive element, hindering the perception of the painful stimuli. Virtual reality is a     method of active distraction that offers the child a multi-sensory immersive interaction that     found many applications for pain management in adult patients. However, very few studies have     tested the efficacy of distraction by virtual reality on procedural pain and anxiety in     children with burn injuries.      This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual     reality prototype developed specifically for the hydrotherapy room of children under seven     years old for the relief of procedural pain in children with burn injuries. The aim of the     RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving     procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for     burn injuries.   "
22854|NCT02986451|"     This phase II study investigating the efficacy and safety of a combination of     biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.   "
22855|NCT02986438|"     The purpose of this study is to investigate the short and long term clinical and cognitive     effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz     frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to     examine possible changes in brain structure and functional connectivity associated with this     intervention.   "
22856|NCT02986425|"     The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic     Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA)     implemented by an appropriately qualified team will lead to an improvement in clinical and     economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.   "
22857|NCT02986412|"     We would suggest to conduct VOLUME-2 study, as an extension of the ongoing VOLUME study     with all subjects already included. After completion of VOLUME study, the study will be     directly extend with an open-label design. All participants, who agreed to pursue, with     either Placebo or CG428, will receive CG428 treatment for an additional six-month period.     VOLUME-2 study would be ideal and timely by enabling no interruption of product use.      The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months :     6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder     populations.      Secondary Objectives are :        -  Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant          progression)        -  Evaluate motivation and adherence of subjects        -  Long term safety   "
22858|NCT02986399|"     The study examines if the introduction of a fast track pathway for hip fracture patients had     an influence on mortality and quality of life by comparing these outcomes between all hip     fracture patients operated at Akershus University Hospital two years before and two years     after this change in standard care.   "
22859|NCT02986386|"     Oral health is a critical factor of systemic health, although usually forgotten. A potential     relation between cognitive deficits and oral diseases has been suggested. Adult cognitive     dysfunctions have a high impact, not only economic, but social and in the family environment.     Based on anatomical connectivity between the oral cavity and the central nervous system, the     proposed study hypothesizes that masticatory function is a relevant determinant of human     cognitive health. The restoration of canonical masticatory function and masticatory training     could help to delay the development of such conditions. This project will also test if     restoring phasic masticatory function improves the execution of cognitive tasks.   "
22860|NCT02986373|"     This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability     of risankizumab in subjects with psoriatic arthritis (PsA) who have completed all doses of     study drug and the Week 24 visit of Study 1311.5 (Phase 2 randomized control trial in PsA     subjects, sponsored by Boehringer Ingelheim).   "
22861|NCT02986360|"     1. To develop brief informational videos, Vidscrips, that can be sent to women following          their mammogram to provide personalized information that integrates breast density with          overall breast cancer risk, and provides information about additional care          recommendations and talking tips for conversations with the health care providers.        2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography.          The investigators hypothesize that individuals in the intervention arm (vs. those in the          standard care arm who receive a letter with the language required by the legislation)          will have more accurate knowledge of their overall risk of breast cancer, their          Mammographic Breast Density (MBD) result, more appropriate observed and intended use of          additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI) will be          reserved only for women at high risk of breast cancer], better satisfaction with their          episode of breast cancer screening, less decisional conflict about their personal          decision for any additional evaluation, and less worry about breast cancer.   "
22898|NCT02985879|"     The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics     of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).   "
22862|NCT02986347|"     The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In     the last decade some studies have described the performance of this surgery using local     anesthesia with adrenaline without the necessity of sedation or the use of pneumatic garrote,     having good effectiveness and substantial reduction of costs. However there is need for     studies with an appropriate design and methodology to evaluate the actual effectiveness of     this kind of anesthesia for the surgical treatment of CTS.      Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized     trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local     anesthesia with adrenaline without limb garroting (Lalondi).      Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of     Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with     co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This     study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in     78 patients. The following primary outcomes will be assessed: Pain through visual analogue     scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be recorded. The     secondary outcomes will be: Use of Analgesics, Anxiety and Depression through the HADS     (Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston Carpal     Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical intervention,     complications and failures.   "
22863|NCT02986334|"     This study is designed to examine brain properties for placebo response in chronic back pain     patients. The investigators have preliminary data indicating that, in blinded clinical trial     studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can     be subdivided into placebo responders and non-responders, and these differences are     PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical     utility and that its properties can be studied by human brain imaging techniques. In Phase I     of the study, the investigators seek to identify brain imaging parameters that predict the     propensity for the placebo response in an independent CBP cohort. In Phase II, the     investigators will evaluate the interaction between placebo response and medication treatment     in individuals stratified as placebo responders versus non-responders. This research is     designed to critically assess the neurobiology of placebo analgesia for chronic pain in a     partially-blind clinical trial.   "
22864|NCT02986321|"     The purpose of this study is to evaluate the dose-response relationship of different doses of     CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further     development in the target patient population.   "
22865|NCT02986308|"     The aim of this study is to confirm the TCM syndrome types and TCM constitution     classifications of the patients with intestinal polyps via on-site epidemiological survey, to     analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to     study the metabolomics differences of the two populations and the metabolomics variations of     the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this     study is to investigate the serum metabolomics variations of patients with intestinal polyps     of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types     and TCM constitution classifications, to determine the correlation among pathology, TCM     constitution, TCM syndrome types and the metabonomics variations of patients with intestinal     polyps.   "
22866|NCT02986295|"     Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with     Xience® stent   "
22867|NCT02986282|"     Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical     cardioversion. Ankle brachial index will be measured three times with oscillometric method     and three times with doppler method. Two study sessions will be performed: the first before     and the second after electrical cardioversion. The first session will be ended before     anesthesia. The second session will be started before a conscious patient will be transported     from intensive care unit to general ward.      All the measurements will be taken in the intensive care unit at an ambient temperature of     21° C, after patients will give their written informed consent to participate in the study.     All patients will be awake, fasting and in the supine position. ABI will be measured     according to the guidelines issued by AHA. Systolic blood pressure will be measured using a     Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid     sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method     will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau,     Switzerland). The appropriate cuff size will be used with the width of the cuff being at     least 40% of the limb circumference. The arm with higher systolic blood pressure will be used     to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or     dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI     measurements will be repeated 3 times with each method in the reverse order of the preceding     measurement e.g., in the case of the initial counterclockwise sequence: right arm, right     popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm,     the clockwise sequence will be used, starting and ending with the left arm. The same sequence     of limb pressure measurements will be used used during the study.      A sample size calculation was based on the preliminary observations made by the study team.     It was calculated that the study sample size of 79 subjects would be needed to detect a     difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a     two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size     of 115 patients incorporated an assumption of dropout due to non-effective electrical     cardioversion, patient decision to quit study or failure to obtain adequate ABI.      The measurements will be repeated three times with each method and for the each method the     mean will be used for the calculations. Investigator - study nurse, trained at the vascular     department, will perform all ABI measurements.   "
22868|NCT02986269|"     General anesthesia has been demonstrated to have a negative impact on lung function. Both     surgery and patient position influence the perioperative lung function. Laryngeal mask airway     (LMA) has been proved to be safe and efficient to maintain the airways patent during general     anesthesia. Pressure support ventilation (PSV) with LMA is routinely used in clinical     practice. The aim of the present trial is to characterize perioperative changes in lung     volume, ventilation inhomogeneity and respiratory mechanics in patients in the lithotomy     position and spontaneously breathing through LMA with and without PSV.   "
22899|NCT02985866|"     The objective of the study is to assess the efficacy and safety of home use of a     Control-to-Range (CTR) closed-loop (CL) system.   "
22900|NCT02985853|"     The goal of this project is to examine the physical mechanisms that contribute to     improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of     bariatric surgery.   "
22914|NCT02985671|"     The purpose of this study is to determine whether the fixed combination of orphenadrine,     acetaminophen, caffeine and diclofenac sodium is more effective in the treatment of an acute     episode of mechanical postural low back pain than Voltaren®. Will be randomized 110     participants of both sexes, aged 18 years or older and less than 65 years of age with an     acute episode of mechanical postural low back pain and they will be allocated to one of two     treatment groups: Group 1: Fixed combination of orphenadrine, acetaminophen, caffeine and     diclofenac sodium; or Group 2: Voltaren®   "
22869|NCT02986256|"     The TELEPIED project aims to show that it is possible to reduce the number of hospitalization     days of a patient with ulcers of the foot thanks to a new organization of care, based on the     intervention of a coordinating nurse interacting with the nurse in charge of the patient     thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular     follow-up of the evolution of the wound and adapting the support nurse to the home if     necessary.      It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of     the foot.      Patients included in the conventional group will be followed according to the usual practice     Patients included in the telepied group will benefit from a personalized accompaniment by a     nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting     by delegating tasks of the investigator.      The patient will be visited by the referring nurse every 15 days. During these visits, the     referring nurse will have the objective to evaluate the evolution of the ulcer as well as the     care performed. This visit also allows a close personalized accompaniment for the patient,     who will benefit from an education adapted to the characteristics of ulcer (discharge     modalities for example ..) and its way of life.      Every patients will be followed for one year (12 months).   "
22870|NCT02986243|"     The purpose of this study is to determine if an assigned physical fitness program will result     in weight loss to prepare patients for kidney transplant.   "
22871|NCT02986230|"     The objective of this project is to implement and evaluate the effectiveness of a     sophisticated Web-based, electronic health record (EHR)-linked clinical decision support     (CDS) system designed to improve primary and secondary cancer preventive care.      This project will engage a rural population with substantial healthcare disparities and gaps     in the receipt of primary and secondary cancer prevention. Results will advance dissemination     and implementation research methods that can reduce health disparities and improve healthcare     for millions in medically under-served areas.   "
22872|NCT02986217|"     This study seeks to establish the effect of regular structured feedback on surgical     performance using crowd sourced video assessments with validated objective performance scores     and time to complete a specific surgical procedure through a randomized controlled trial. The     working hypothesis is that regular structured assessment will lead to a greater measurable     improvement in performance, as defined by objective performance scores, than will traditional     feedback methods.   "
22873|NCT02986204|"     This study will investigate in-office ultrasound localization vs localization in radiology     for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and     aims to help establish best practices in this domain. Investigators will also create an     ultrasound image gallery of palpable and non palpable as well as instructional video for non     palpable ENG implant removal.   "
22874|NCT02986191|"     Twenty patients with gingival recession will be enrolled in this trial. Gingival recession     will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while     on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.      Patients will be followed for 3 and 6 months by measuring the clinical indexes and     statistical analyses will be performed to compare the results and to assess the success of     Mucograft®.   "
22875|NCT02986178|"     This is a randomized phase 2 study of oncolytic polio/rhinovirus recombinant (PVSRIPO) alone     or in combination with the chemotherapy drug lomustine in adult patients with recurrent World     Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor     Center (PRTBTC) at Duke.   "
22876|NCT02986165|"     This study evaluates the acute and longer term effects of a tomato pomace extract on platelet     aggregation in health subjects.   "
22877|NCT02986152|"     The Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic     stress disorder (PTSD) in cancer patients and caregivers. Based largely on PTSD Coach from     the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms     and is tailored specifically to individuals impacted by cancer.      This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a     randomized controlled trial (RCT) where subjects are placed into either the intervention     group or the wait-listed control group for a period of 8 weeks. The CDC app is available as a     free download on the App Store® and on Google Play™.   "
22878|NCT02986139|"     Assess the injection site pain associated with a New Etanercept formulation in adult subjects     with RA or PsA   "
22879|NCT02986126|"     Depressive symptoms and disorders are among the most common adult health conditions with a     lifetime prevalence of 15-20% and are a leading cause of disability /morbidity worldwide.     Although evidence-based approaches such as cognitive behavioral therapy (CBT), antidepressant     medications, and depression collaborative care and quality improvement (QI) programs     integrating depression care into primary health care can improve depression outcomes and     disparities, racial / ethnic disparities continue to persist. Concurrently, according to a     2011 Institute of Medicine (IOM) report, little information exists on how to address the high     rates of depression among sexual and gender minorities.      Our study randomizes depressed, LGBTQ (lesbian, gay, bisexual, transgendered, queer), racial     / ethnic minority adults to an evidence-based agency-level, depression quality improvement     (QI) training [Resources for Services (RS)] and technical support alone or to a resiliency     class (RC+), a 7-session resiliency, cognitive behavioral therapy class to enhance mood +     automated mobile text reminders about basic reminders and care follow-up impact on improving     adult patients' depressive symptoms. Depression QI (RS) training will be offered to three     clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA)     and one cluster in NO. Clusters are comprised of one primary care, one mental health, and two     to three community agencies (e.g., faith-based, social services/support, advocacy). All     programs will receive depression QI training. Enrolled adult depressed patients (n=320) will     be randomized individually to RC+ or RS (depression QI) alone to assess effects on primary     outcomes: depressive symptoms [8-item patient health questionnaire (PHQ-8) score and     secondary outcomes: mental health quality of life [12-item mental composite score (MCS-12) ≤     40], Resilience (Brief Resilience Scale), mental wellness, and physical health quality of     life [12-item physical composite (PCS-12)score] at 6- and 12-month follow-up.   "
22880|NCT02986113|"     This study will determine if suicidal middle-aged men who use a personalized computer program     addressing suicide risk before a primary care visit are more likely to discuss suicide and     accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important     because half of all men who die by suicide visit primary care within a month of death, yet     few broach the topic, missing chances for prevention.   "
22881|NCT02986100|"     The purpose of this study is to characterize the mass balance, absorption, metabolism, and     elimination pathways of orally administered [14C] rucaparib followed by cycle by cycle     treatment with rucaparib continuing until disease progression or other reason for     discontinuation   "
22882|NCT02986087|"     Tracheal occlusion IDE approved by FDA for severe congenital diaphragmatic hernia fetuses.   "
22887|NCT02986022|"     Background:      Resilience is important for successful adaptation. The investigators' resilience intervention     was effective in enhancing resilience, emotional functioning, and adaptation in Mainland     immigrants. In the present proposal, the investigators will work with the International     Social Service to scale up application of this intervention in immigrants, and develop the     training infrastructure to ensure that the evidence-based intervention can be sustained     despite turnover of interventionists.      Objectives:        1. We will conduct a randomized controlled trial to compare the resilience intervention          with the resilience + information intervention (a compound module) among 200 new          immigrants,        2. The resilience intervention will enhance participants' resilience by 5%, and decrease          their depressive symptoms by 20% and adaptation difficulties by 10% after the completion          of the intervention,        3. The resilience + information intervention will have higher increases in resilience and          more decreases in depressive symptoms and adaptation difficulties compared to the          resilience intervention, and        4. To establish a sustaining mechanism which ensures that these two interventions can          continue to be used in routine services.      Project design:      Well-trained social workers will deliver the intervention. Participants will complete     programme evaluation. A train-the-trainer workshop and training materials will be prepared to     transfer knowledge to social workers who are future trainers.   "
22888|NCT02986009|"     The collaborator has its vision as To have children, individuals, families and migrants     across countries live in dignity and harmony, and be contributing members to a just, humane     and caring society. Parents are very significant in the families as they need nurturing,     discipline, teaching, monitoring, and managing their children as well as their families.     Capable and competent parents bring good child outcome and happy family. The investigators     planned to serve targeted parents in two areas as 1. Emotion management and 2. Information on     community resource. In the first set, the participants are expected to improve their emotion     management leading to a more effective parenting. In the second set, the participants would     acquire more information that enables them to better use the community resources.      To work closely with the collaborator, and based on the previous results of an effective     parenting intervention, the investigators will modify the intervention to tailor the needs of     targeted parents. The objectives are:        1. After completing the parenting intervention, 150 participants will, 1.1. To increase          participants' emotion management strategies by 20%, 1.2. To enhance positive affect by          10%, 1.3. To decrease negative affect by 10%, 1.4. To enhance satisfaction with the          parent-child relationship by 10%, 1.5. To increase subjective happiness by 8%, 1.6. To          enhance family harmony by 5%, These levels of positive effects of the program were          projected from the investigators' published findings.        2. After joining the information sessions about education, health care, housing,          employment, and community facilities, another 150 participants will, 2.1 To know more          information of Hong Kong by 50%, 2.2 To know more information of Mainland China by 50%,          2.3 To use more community resources either in Hong Kong or Mainland China by 50%.      To study the effectiveness of parenting intervention, the investigators proposed to use a     randomized controlled trial (RCT) that is a type of scientific study to reduce bias.     Participants in this project will be randomly allocated to either the emotional management     group or the information group. As the information group has no focus on parenting,     participants would show no significant improvement in emotion management strategies or     satisfaction with the parent-child relationship, etc. Meanwhile, participants in the     parenting intervention would show no significant improvement in knowledge about either Hong     Kong or Mainland China.   "
22889|NCT02985996|"     The purpose of this study is to determine the ability of new anti-HIV agents to penetrate     different body compartments in HIV negative men who have sex with men and transgender women.     These new agents might be considered for pre-exposure prophylaxis regimens in the future.     This study will include 90 healthy, HIV-negative men who have sex with men and transgender     women who are not taking hormones aged 18-49 years. Participant must be willing to     participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and     willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.   "
22890|NCT02985983|"     To evaluate the efficacy of KHK4827 in axSpA (ankylosing spondylitis [AS] and     non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as     measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis     international Society (ASAS) 40 response at week 16.   "
22891|NCT02985970|"     Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However     several steps of RSI are not based on evidence based data (EBM) and are considered     controversial. In an electronic evaluation form that will be send to Czech society of     anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4     clinical scenarios in which RSI should be used. In the questionnaire the participants have to     choose RSI or no and they have to describe all the next steps on anesthesia induction process     in each single clinical scenario.   "
22893|NCT02985944|"     Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy     withdrawal time >6min has been suggested to increase the ADR since it allows for thorough     evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy     system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle     view. In the present study the authors evaluate the impact of WT on ADR for High Definition     Standard Endoscopes with just a single imager to the FUSE endoscope.   "
22894|NCT02985931|"     The investigators aim to address this issue with novel image quantification methods using     CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the     quantification of the coronary flow. The investigators will use kinetic modeling techniques     to design a study that allows the absolute flow quantification. To make this study practical,     the investigators will develop a protocol that includes the acquisition of both the rest and     stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow     will be validated against the flow measured with cardiac MRI scans. Patients with high CAD     risk will be recruited for the clinical trial. Data from these human subjects will be used     for determination of the performance of the developed algorithm. With the proposed rapid scan     with absolute quantification capabilities, the investigators expect to increase the diagnosis     accuracy while maintaining the patient throughput.   "
22895|NCT02985918|"     The main purpose of the present study is to verify whether, as compared with     conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive     positive pressure ventilation may more effective in correcting hypercapnia, hence reducing     the need for intubation and improving survival in patients with acute exacerbation of chronic     obstructive pulmonary disease.   "
22896|NCT02985905|"     Although several studies have considered the relationship between infertility and semen thiol     compounds levels, no study on the effects of asthenospermia treatments such as oral zinc     supplementation on thiol related enzymes activity which are important in fertility of the     individual has been reported.   "
23035|NCT02984098|"     The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood     glucose concentration and to reducing of pain before painful procedures on healthy term     neonate 72 hours aged.   "
22901|NCT02985840|"     Nausea is a common complaint in patients who present to the emergency department (ED).     Although the number of conditions that can present with nausea are numerous, the mainstay of     treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but     also its availability. One of the major drawbacks to using this form is that it often needs     to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV     ondansetron given with IV dexamethasone (Decadron) as another viable option when treating     patients with nausea in the emergency department.      Previous studies in patients undergoing surgical procedures have shown that when IV     dexamethasone is given with IV ondansetron to post-operative patients they have less nausea     and vomiting than ondansetron alone, and were even found to show decreased post-operative     pain associated with nausea. It has also been shown to decrease the need to re-dose     antiemetic medication. Although this combination has not been tested in the emergency     department it is believed by these investigators that the additional use of dexamethasone may     decrease the need to use repeated doses of ondansetron.      The investigators believe this may change the way physicians currently approach the nauseated     patient in regards to treatment. That rather than possibly giving multiple doses of one     medication over and over to reduce a patient's nausea, physicians can give two medications     together at one time. The investigators hope to demonstrate that by giving intravenous     dexamethasone and ondansetron together, it may be possible to reduce the number of patients     who need additional doses of nausea medication.   "
22902|NCT02985827|"     The purpose of the study is to analyze the sensation to eye drops containing menthol in     people with healthy eyes and in people with dry eyes. This study also examines the     temperature of your eye using an Infrared Camera.   "
22903|NCT02985814|"     Background: Asthma and COPD are considered different diseases but many patients share     characteristics of both entities. This has been termed COPD-asthma overlap syndrome.      Study objective: To examine: (a) the frequency of the overlap phenotype among patients     referred for pulmonary function testing and, (b) the impact of this phenotype on the     therapeutic management and the quality of life of these patients as compared with patients     with COPD only and asthma only.      Methods:      Type of study: Observational, cross-sectional. Study subjects: Patients referred for     pulmonary function test diagnosed with airway obstruction (FEV1/FVC < 0.7) willing to sign an     informed consent.      Study procedures: Spirometry will be performed before and after the administration of a     bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history     of asthma and wheezing, current medications and history of exacerbations will be administered     at inclusion. Questionnaire on medication utilization will be administered by telephone one     month after inclusion. Quality of life: Will be assessed using the Saint George Respiratory     Questionnaire (SGRQ).      Working definitions: The following definitions will be adopted: a) COPD only: smoking history     > 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of < 0.70; b) Asthma only: (1)     presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or FVC of 12%     and 200 ml; (2) prior physician diagnosis (before age 40); and c) both COPD-Asthma (the     overlap group) - the combination of the two.      Outcome measures: The clinical outcome is the prevalence rate of the phenotypes.     Patient-reported outcomes will include the utilization of medication, the number of     exacerbations, and quality of life.   "
22904|NCT02985801|"     Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in     patients with unresectable pancreatic cancer?   "
22905|NCT02985788|"     Loss of elbow range of motion can significantly affect activities of daily living. Measuring     elbow range of motion is critical for tracking post surgical outcomes. This study seeks to     validate the ability to validate self photography as a means of followup through long     distance correspondence.   "
22906|NCT02985775|"     Cytomegalovirus (CMV) infections remain an important cause of morbidity and mortality in     allogeneic hematopoietic cell transplant (HSCT) recipients, especially in patients received     haploidentical transplantation. During the past decades, prophylactic or preemptive treatment     with antiviral drugs has significantly reduce the incidence of early-onset CMV infection.     Unfortunately, prolonged antiviral treatment is associated with substantial toxicity and may     delay recovery of virus specific immune responses, resulting in an increasing of late-onset     CMV disease.      To date, adoptive immunotherapies have been developed as treatment alternatives to antiviral     agents for CMV infection after HSCT. Studies have demonstrated that prophylactic or     preemptive therapy with donor CMV-specific T cells can restore antiviral immunity and clear     CMV viremia after transplantation. In this prospective clinical phase I/II trial, we propose     to reconstitute antiviral immunity against CMV by preemptive transfer of CMVpp65-specific T     cells (CMV-CTLs) at an early time point after allogeneic stem cell transplantation. We also     propose to demonstrate whether protect against CMV is associated with recovery of CMV-CTLs.   "
22907|NCT02985762|"     The primary objective of this study is to characterize the pharmacokinetic (PK) profile of     EXPAREL when administered via local wound infiltration to subjects undergoing open spinal     fusion or reconstructive surgery.      The secondary objectives of this study are to assess the safety, tolerability, and efficacy     of EXPAREL in this surgical model.   "
22908|NCT02985749|"     This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for     social impairment in children and adults with high functioning autism spectrum disorders     (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in     improving social deficits in individuals with ASD.   "
22909|NCT02985736|"     A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily     BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis   "
22910|NCT02985723|"     The aim of the present study is to evaluate the postoperative visual acuity for distance,     intermediate and near vision as well as the cylinder correction and the patient satisfaction     after bilateral implantation of AT LISA tri toric 939MP IOLs.   "
22911|NCT02985710|"     Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel     noninvasive method to detect sudomotor dysfunction. Several small studies have recently shown     that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes mellitus) can     be performed non-invasively, quickly and effectively. The investigators aim to study the use     of Sudoscan in rare disease condition associated with small fiber polyneuropathy.   "
22915|NCT02985658|"     This is an expanded access protocol to allow continued maintenance therapy with ABT-888     (veliparib) for three patients with metastatic triple negative breast cancer who are     currently receiving the investigational product in association with clinical trial     participation. Additionally, the protocol will enroll up to 7 new patients with metastatic     BRCA associated or triple negative breast cancer to allow for additional access to veliparib     monotherapy, or at the investigator's discretion, veliparib in combination with cisplatin     and/or vinorelbine.   "
22916|NCT02985645|"     This study is intended to evaluate the efficiency of graftless maxillary sinus augmentation     with concentrated growth factor (CGF) utilizing dynamic implant valve approach (DIVA)     system.   "
22917|NCT02985632|"     An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to     evaluate pharmacokinetics in this patient population.   "
22918|NCT02985619|"     Background: Diabetic macular edema (DME) shows a sustained functional and morphologic     response to anti-vascular endothelial growth factor (VEGF) drugs, but the optimal approach     for persistent macular edema still in debate.      Purpose: To evaluate 24-week visual and anatomical effects of intravitreal bevacizumabe or     triamcinolone in patients who had residual edema after 24-weeks to pro re nata(prn)     intravitreal bevacizumabe therapy.      Methods: This study enrolled a total of 100 DME eyes. Each patient received prn     bevacizumabe therapy throughout 24 weeks. At week 24, patients who had recurrent or     persistent edema were randomized 1:1 to Group 1 (prn bevacizumane) or Group 2 (prn     triamcinolone). Patients with no recurrent or persistent edema at week 24 were comprised     Group 3 and continue received prn bevacizumabe. Prn treatment was administered when central     subfield thickness of the macula (CST) > 300 µm and/or there were intraretinal cystoid spaces     in the fovea. Study visits occurred every 4 weeks with the endpoint at week 48. At each     visit, patients had an eye exam and CST, best-corrected visual acuity (BCVA), and intraocular     pressure (IOP) were assessed. Fundus photography and fluorescein angiography were also     performed at baseline, week 16, week 40, and week 48. Rescue therapy using laser     photocoagulation could be administered at the discretion of the Investigators. All patients     resumed standard care after exiting.   "
22919|NCT02985606|"     Investigate how manipulating the time between caffeine ingestion and exercise may alter     exercise performance and cognition   "
22920|NCT02985593|"     The objectives of this study are to evaluate the safety and tolerability of a single     intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a     placebo-controlled, single-blind comparative study, and to evaluate the safety and     tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an     open-label study.   "
22921|NCT02985580|"     Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties,     which in rodent models are neuro-protective. The risk of developing dementia is reduced in     people habitually consuming high flavonoid intakes, but data from human intervention studies     is sparse. We therefore investigated whether 12 weeks of blueberry concentrate     supplementation improved cognitive function in healthy elderly via increased brain activation     and perfusion.   "
22922|NCT02985567|"     The study involves a prospective evaluation of chloral hydrate sedation for the measurement     of intraocular pressure in children ages one month to five years of age.   "
22923|NCT02985554|"     This is an open-label, dose escalation Phase I study to evaluate the tolerability and     efficacy of single agent of Nivolumab as maintenance treatment to prevent relapse in patients     with hematologic malignancies after allogeneic stem cell transplantation. Approximately 29     patients will be enrolled, where about 6-12 patients will be included on the dose escalation     phase and 20 patients will be on the expansion cohort at maximal tolerated dose.   "
22924|NCT02985541|"     The study is performed to assess if Mirena is effective and safe as a birth control method     beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted     for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.   "
22925|NCT02985528|"     Clinical risk assessment and management is mostly relevant in emergency. Thoracic ultrasound     (TUS) has been proposed as an easy-option replacement for chest X-ray (CXR) in Emergency     diagnosis of pneumonia, pleural effusion and pneumothorax. Investigators investigated CXR     unforeseen diagnosis, provided by TUS, exploring usefulness and sustainability of     telementoring aimed at the management of clinical risk. This observational report includes a     period of six months with a proactive concurrent adjunctive telementoring in TUS diagnosis     using freely available smartphone applications for the transfer of images and movies.   "
22926|NCT02985515|"     The purpose of this research study is to determine if budesonide nasal saline irrigation or     smell training intervention impact sense of smell.   "
22927|NCT02985502|"     Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the     reason why this form of surgery technique is seldom performed. However, with the progress of     medical and surgical care nowadays, patients undergone TP could receive better care in     endocrine and exocrine insufficiency. In addition, with better understanding of benign     pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused     pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the     quality of life of patients with pancreatogenic diabetes after TP is still currently     controversial.      Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care     activities and quality of life in patients with pancreatogenic diabetes after total     pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.      Method: A correlational and comparative cross-sectional approach will be used. The data will     be collected with a structured questionnaire via purposive sampling of 120 subjects in an     outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1)     age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to     participate in the study and sign informed consent. Exclusion criteria will be the patients     diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go     through propensity score matching and will be analyzed by using descriptive statistics,     paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.      Anticipated achievement: The anticipated achievement of this study is to understand the     relationships between fatigue, self-care activities, and quality of life in patients with     pancreatogenic diabetes after pancreas surgery. In addition, through this study, the     influence of diabetes to patients after pancreatic tumor resection can be explored; and the     factors that influence the population's quality of life can be examined. By the filling of     this knowledge gap, intervention can be planned accordingly to help improve the population's     quality of life.   "
22928|NCT02985489|"     Malnourished patients with IBD that receive pre-operative parenteral nutrition therapy will     have fewer post-operative complications compared to malnourished patients that receive     standard of care nutritional therapy.   "
22966|NCT02984995|"     This is a Phase 2, multi-center, open-label, single-arm study to evaluate the efficacy,     safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD     positive refractory or relapsed acute myeloid leukemia.   "
22929|NCT02985476|"     This study evaluated the extent to which a shared health record facilitated better     communication, increase individual responsibility for health care and reduce demand for     health resources.      The study made individualised reports available to patients and General Practitioners and     gave much more detail about participants chronic disease and treatments, and evaluated its     effectiveness in a randomised controlled feasibility trial.      One third of patients received care as usual, two thirds of patients received the     intervention.   "
22930|NCT02985463|"     Left Atrial Appendage Occlusion and Biomarker Evaluation (LABEL) is a single-center,     prospective and observational study evaluating changes of the expression of biomarkers in     eligible patients before and after percutaneous implantation of a left atrial appendage (LAA)     occlusion device at mid-term follow-up.   "
22931|NCT02985450|"     (1) Due to missed childhood vaccination programs, the majority of adult patients with NAFLD     in Canada do not have immunity to hepatitis B. (2) Adults with NAFLD who receive the HBV     vaccine have reduced immunogenic responses in the setting of obesity (i.e., protective     anti-HBs titres). Aims: (1) To determine the sero-prevalence of immunity against hepatitis B     in a cohort of prospectively evaluated adult NAFLD patients. (2) To prospectively determine     HBV vaccine responses (anti-HBs titres) in adult NAFLD patients.   "
22932|NCT02985437|"     Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in     preterm infants. Here the drug is administered via airways.      The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is     not yet approved for the treatment of wound healing disorders. In the planned clinical trial     Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No     substance related side effects were observed during the application via airways in neonates.      The innovative idea to use lung surfactant for skin wound healing derived from two     observations. First, when the skin is injured, the barrier protecting the moist body surface     from the dry environment is discontinued and in part lost.      Lung surfactant has several characteristics that might be beneficial for treatment of chronic     cutaneous wounds.   "
22933|NCT02985424|"     The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose     Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern     of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica     (PMR)/Giant Cell Arteritis (GCA) .   "
22934|NCT02985411|"     Gardening interventions yield a multitude of measurable benefits that are evaluable within     the context of a clinical trial. Harvest for Health forges new inroads in the delivery of     holistic interventions to high risk populations, in this case, older cancer survivors. Since     the intervention banks on an existing organization's infrastructure, it can easily be     disseminated nationwide. The next step is to prove efficacy - an essential step in     contributing to the science in this area, and one which is crucial for future dissemination.   "
22935|NCT02985398|"     An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine   "
22936|NCT02985385|"     To prove that palliative therapy can be practised for congenital lethal malformations within     the Islamic Code of Ethics.      After defining lethal malformation no respiratory support is offered and newborns are     provided with compassionate care.   "
22937|NCT02985372|"     This prospective multicenter clinical study was designed to assess the efficacy and safety of     decitabine in combination with low-dose cytarabine induction treatment for elderly patients     with newly diagnosed acute myeloid leukemia (AML).   "
22938|NCT02985359|"     The goal of this evaluation is to assess the impact of a 3.5 year, World Food Program (WFP)     supplemental child feeding and nutrition services program in reducing stunting and improving     linear growth in children from 6 through 24 months of age in a rural district of Malawi.   "
22939|NCT02985346|"     Pulmonary hemosiderosis (PH) is a pulmonary hemosiderin deposition which caused by alveolar     capillary hemorrhage. PH is easy to recurrent and can lead to pulmonary fibrosis and     insufficiency if the disease was poor controlled. Steroid is the most common drug that was     administered in acute phase of the disease. However, considered the side-effects, steroid is     not suitable for long-time maintenance. Therefore, it is necessary to explore a new therapy.     Bone marrow mesenchymal stem cells (BMSC) are a kind of adult stem cells with high     self-renewal and multi-directional differentiation potential in bone marrow. It has become a     hot topic in immunosuppressive and tissue repair therapy in recent years. To date, homing,     colonization and differentiation of BMSCs in the lung have been observed in animal models of     pulmonary hypertension, radiation pneumonitis and pulmonary fibrosis. It had been reported     that BMSC transplantation in acute lung injury in mice, inflammation of lung injury can     significantly improve. The aim of this study is to explore the effect of BMSC on PH and its     mechanism, and to explore a new way to promote the repair of IPH. It is expected to improve     the status of IPH therapy in children, especially improve the prognosis of refractory PH.   "
22940|NCT02985333|"     The purpose of this study is to evaluate the efficacy and safety of paclitaxel in combination     with cyclophosphamide and dexamethasone in chinese patients with relapsed/refractory multiple     myeloma.   "
22941|NCT02985320|"     The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults,     children and infants in a phase I open-label study, and then assess its immunogenicity and     safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and     controlled study.   "
22942|NCT02985307|"     This study evaluates the efficacy of a mobile telehealth short message service as a     facilitator for weight management. Half of the participants will receive a standard care     weight management group intervention, while the other half will receive daily text messages     via their mobile phone to help facilitate weight loss. It is hypothesized that the     intervention group receiving text messages will be as successful as the control group at     achieving weight loss over a 3-month period.   "
22943|NCT02985294|"     This study evaluates peripheral nervous system function using Multiple Excitability Measures     (MEM) to obtain electrophysiological pain phenotypes   "
22944|NCT02985281|"     Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian     Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.   "
29694|NCT02896998|"     The objective of this trial is to demonstrate that the functional outcome of 'removal on     demand' of the syndesmotic screw is non-inferior compared to routine removal of the     syndesmotic screw in patients with an ankle fracture.   "
22945|NCT02985268|"     At present, the optimal treatment strategy for heart failure patients and moderate-to-severe     (3+) or severe (4+) mitral regurgitation with a class IIa recommendation for CRT is     uncertain.Whether these patents should also be treated for functional mitral regurgitation or     with CRT also remains unclear. We therefore propose a randomized 2x2 factorial design in this     patient population to understand the the impact of both CRT and transcatheter mitral valve     repair with the MitraClip on their functional status and quality of life.   "
22946|NCT02985255|"     Patients enrolled for the study, who are eligible for NACT, will undergo a pre-treatment     workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and tissue biopsy     along with a PET-CT scan. Subsequently, they would undergo 3 cycles of NACT (weekly thrice)     with DCF. They would be reassessed with PET-CT and EUA +/- biopsy after the end of the third     cycle. Those who are achieving CR would undergo adjuvant CTRT. Subjects who have a PR in the     PET-CT scan will be re-classified based on the biopsy report. If they remain in the PR group     they will undergo surgery but if the biopsy in is negative for malignancy, they will undergo     adjuvant CTRT. Those subjects with SD or PD would undergo surgery. Subsequently, further     radiation and/ or chemotherapy will be decided based on the final histopathology (of the     surgical specimen) reports.      PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment     completion.   "
22947|NCT02985242|"     This is a prospective, randomized, active control, two-arm parallel, double-blind, monocenter     phase IV clinical trial. The trial compares empagliflozin to glimepiride in patients with     type 2 diabetes mellitus in addition to standard of care treatment.      Patients with type 2 diabetes mellitus who are between 18 and 80 years of age will be     recruited for the clinical trial and randomly allocated to either receive empagliflozin or     glimepiride.      The assumption of the study is that empagliflozin slows down diabetic retinopathy progression     rate and thus a lower microaneurysm formation rate compared to subjects treated with     glimepiride by substantially decreased cellular glucotoxicity will be achieved.   "
22949|NCT02985216|"     A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the     Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic     Pain   "
22950|NCT02985203|"     This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety     of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in     Patients with advanced Non-Small Cell Lung Cancer.      The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive     combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the     combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will     be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy     with metronomic oral Navelbine (Arm A) or other regimen (Arm B).   "
22951|NCT02985190|"     This study is a phase II of effcicacy and tolerance of azacitidine in patients with     myelodysplatic syndrome and steroid dependent or resistent systemic auto-immune and     inflammatory disorders   "
22952|NCT02985177|"     MSK-I is the most common cause for ED visits for children with pain, with a child's risk of     sustaining a fracture ranging from 27-42% by the age of 16 years. MSK-I is known to generate     moderate to severe pain in most children and the ED serves as the critical entry point for     these injured children. This study aims to provide rapid and sustained pain management for     children presenting with a MSK-I in the ED. The investigators will compare the efficacy of 2     possible medication combinations (fentanyl intranasal + oral hydromorphone or fentanyl     intranasal + oral ibuprofen) for the rapid, adequate and sustained pain management of     children with suspected fracture.      The investigators believe that the addition of HM to INF will lead to better pain treatment     by providing a consistent and adequate level of analgesia throughout the entire ED visit,     including prior to physician exam and during painful radiologic procedures.   "
22953|NCT02985164|"     Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a     result, anesthetists become an inevitable target to the radiation exposure since they have to     monitor patients closely during the operation. Unfortunately, radiation may not have an     immediate sequelae, but an accumulation of adverse effects.      These sequelae happen by means of direct exposure and reflection. The reflected rays is     inversely proportional to the distance between the origin and the target. Practically, the     radiation source can be protected by individual cover and glass shield.      Siriraj hospital is a tertiary, general university hospital with 2,200 beds. Annually, an     Endoscopy centre has over 700 patients undergoing endoscopic retrograde cholangio     pancreaticography (ERCP). Normally, fluoroscopy for pancreatic and biliary ducts     visualisation is needed under anesthesia. Though the procedure is operated in a     well-equipped, radiating-protection room; many medical personnel including 1-2 endoscopists,     2 scrub nurses, 1-2 anesthetists and 1 x-ray man, still have a chance of irradiation.      During ERCP, all medical personnel particularly anesthetists are rinsed by radiation from     here and there. Though they always wear lead aprons and collar shields to protect themselves     from the rays, they are normally in the position - less than 1 meter - close to the     fluoroscopy.      Due to the advancement in technology, anesthetists can remotely monitor patients during the     surgical procedure. This might cause a lesser effect of ray upon them. As a result, whether     or not the positioning of anesthesia personnel relating to the distance of x-ray source would     help to alleviate the effect of radiation exposure.   "
22967|NCT02984982|"     Primary Objective:      To compare the efficacy of alirocumab with standard of care on coronary atheroma progression     in patients who have experienced an acute coronary syndrome (ACS) event and are treated with     atorvastatin or rosuvastatin.      Secondary Objectives:        -  To compare the efficacy of alirocumab with standard of care on absolute change in          percent atheroma volume (PAV) and normalized total atheroma volume (TAV).        -  To evaluate the efficacy of alirocumab on low-density lipoprotein cholesterol (LDL-C),          apolipoprotein B (Apo-B), triglycerides, non-high-density lipoprotein cholesterol          (non-HDL-C) and Lipoprotein(a)(Lp[a]).        -  To evaluate the safety of alirocumab including the occurrence of cardiovascular events          (coronary heart disease [CHD] death, non-fatal myocardial infarction [MI], fatal and          non-fatal ischemic stroke, unstable angina requiring hospitalization).   "
24869|NCT02960152|"     This study evaluated the periodontal status of patients suffering from eating disorders     (anorexia nervosa and bulimia nervosa). The work hypothesis is that eating disorder patients     have a higher risk for periodontal diseases than non-eating disorder subjects.   "
22954|NCT02985151|"     This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of     the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has     not had laser therapy may be eligible to participate. The visits occur every three months for     up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a     lower energy treatment during the study. Subjects and raters will be blinded to which therapy     level the patient receives. At each visit, the scars will be photographed and the subject     will complete a questionnaire to rate the scar prior to treatment. Three physicians will     evaluate the scar at each visit. One rater will evaluate the scars in person during the     visit, while the other two raters will evaluate the scars using photographs after each visit.     During the first three study visits, subjects will receive their assigned treatment, obtain     post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other     skin changes after treatment. At the third study visit, subjects will have the option to     receive additional treatments or terminate their participation in the study. The fourth visit     for those who continue will be a treatment visit for one group and the fifth visit will be     for data collection, with no treatment offered.   "
22955|NCT02985138|"     TLIF is a popular lumbar interbody fusion technique to perform anterior interbody fusion.     Pedicle screws providing initial stability have been developed to correct deformity, improve     the rate of fusion and speed patient's postoperative recovery. Conventionally, an open     approach is required, using bilateral pedicle screw fixation to provide stability as the gold     standard. However, the increased stiffness of the fused segments will reduce the bone mineral     content in adjacent vertebrae, and biomechanical studies have indicated that increased stress     at the levels adjacent to the fusion may increase adjacent segment pathology. Therefore,     unilateral pedicle screw fixation had been considered as a means to decrease the stiffness of     the instrumented segment. Recently, researchers have shown that unilateral instrumented     spinal fusion provides comparable results and is as effective as bilateral fixation. In     addition, the cost-effectiveness of this approach is worthy of attention. To our knowledge,     few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in     lumbar degenerative diseases have been reported. The purpose of this study is to compare     clinical and radiographic outcomes in a series of patients with lumbar degenerative diseases     using instrumented TLIF with unilateral or bilateral pedicle screw fixation.   "
22956|NCT02985125|"     This study is a single-arm, open-label, multi-institutional Phase I/II trial of the     combination of LEE011 and everolimus in refractory mPAC.   "
22957|NCT02985112|"     Revascularization of borderline coronary stenoses (40-70%) is usually driven by fractional     flow reserve (FFR) which expresses the physiological significance of a lesion and tells the     operator whether PCI may reduce the rate of adverse events as compared to medical therapy.     Coronary stenoses with FFR value < 0.80 are indeed associated with a higher rate of adverse     event and requires coronary revascularization whereas lesions with FFR > 0.80 show an     excellent prognosis which cannot be improved by coronary stenting. Such a predictive value of     FFR is theoretically based only on the degree of myocardial ischemia downstream from a given     coronary stenosis: however, also plaque composition may play a crucial role in triggering     future events especially in patients affected by acute coronary syndrome. Differences in     plaque composition between FFR-positive and FFR negative lesions have never been assessed.     Intracoronary Near-InfraRed Spectroscopy (NIRS) identifies lipid rich plaques that can     potentially cause acute events. The aim of this study is to compare the lipid content     expressed by LCBI (Lipid Core Burden Index) between functionally significant (FFR < 0.80) and     non-significant (FFR > 0.80) stenoses in patients undergoing coronary angiography because of     stable CAD and non-ST elevation acute coronary syndromes. This is an observational,     prospective, multicentric study where we plan to collect 150 coronary lesions.   "
22958|NCT02985099|"     The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2%     Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis     (CP) with Type 2 diabetes mellitus patients.   "
22959|NCT02985086|"     The primary aim of this study is to determine if antibiotics combined with immediate     induction can significantly reduce the rate of maternal and neonatal infection compared with     immediate induction alone in women presenting with PROM later than the 37+0 weeks of     gestation. The secondary aim is to compare the rates of infection between immediate and     delayed induction in women submitted to antibiotic prophylaxis.   "
22960|NCT02985073|"     This study compares the outcome using a biological mesh (Veritas®) compared to a non     biological mesh (TIGR®) in immediate breast reconstruction.   "
22961|NCT02985060|"     To study safety and feasibility of mild therapeutic hypothermia after successful     recanalization by mechanical endovascular treatment in patients with acute ischemic stroke     and proximal arterial occlusion.   "
22962|NCT02985047|"     The purpose of the study is to test a standardized version of brief admission (BA) through     randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a     crisis management model for individuals with recurrent self-harm, including suicide attempts     and at least three symptoms of Borderline Personality disorder. Participants will be     allocated to BA + Treatment as Usual (TAU) or TAU.   "
22963|NCT02985034|"     Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and     characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas     immediate technical success is usually assessed by CT. Conventional visual assessment of two     modalities may be more challenging than being anticipated, because acquisition position,     respiration, and spatial resolution differ between the two. Therefore, the study purpose is     to evaluate the results of software-assisted ablative margin assessment using registration of     different pre-and post-RFA modalities compared with the conventional method of side-by-side     MRI-CT comparison in patients with HCCs.   "
22964|NCT02985021|"     In this study, patients who have metastatic prostate cancer that does not respond to hormone     treatment and who have mutations in certain cancer-related genes will be treated with     docetaxel and carboplatin chemotherapy.   "
22965|NCT02985008|"     Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic     manifolds and investigated the current state of treatment and clinical features of     cardiogenic shock in Koreans and identified the factors that could improve the prognosis and     the use of IABP and ECMO And to investigate its therapeutic effect.   "
22968|NCT02984969|"     Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms     and thus has several clinical definitions. According to the Rome III criteria for chronic     constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it     is more prevalent and symptomatic in women and elderly people. Slow transit constipation     (STC) is the major category and is characterized by a decreased rate of colonic transit.      Recently, many researchers have focused on the relationship between intestinal microbiota and     constipation and have demonstrated that intestinal microbiota contribute to the     pathophysiology of functional gastrointestinal disorders.      Thus, there is a need for an improved understanding of gut microbiota composition in     constipation patients and for the potential role played by the gut microbiota in the etiology     of STC.To achieve this goal the investigators characterized and compared the intestinal     microbiota among carefully selected patients with constipation that were clinically     categorized based on Rome III criteria, and healthy controls using high throughput     pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative     changes in the relative abundances of taxa.   "
22969|NCT02984956|"     Correct assessment of a patient's volume status is the most important goal for an     anesthetist. However, most of the variables used for fluid response evaluation are invasive     and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used     monitoring method in many countries. Our aim in this study is to investigate the usefulness     of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture     patients who underwent spinal anesthesia.   "
22970|NCT02984943|"     The purpose of this investigation is to determine the effects and ease of using hyperbaric     oxygen therapy HBO2 for the treatment of rheumatoid arthritis joint pain and prevention of     disease progression. In this study it is our intention to not only evaluate effects and ease     of treatment but time, cost, possible adverse events and effect size in an attempt to predict     an appropriate sample size and improve on the study design prior to a more extensive study.   "
22971|NCT02984930|"     The gastric acid pocket is believed to be the reservoir from which acid reflux events     originate. The risk for acidic reflux is mainly determined by the position of the gastric     acid pocket. Little is known about how changes in position and size of the acid pocket     contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in     patients with gastroesophageal reflux disease. Investigators will conduct a prospective     randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis     that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing     the acid pocket position and size.   "
22972|NCT02984917|"     To investigate the advantages and disadvantages of the anterior transversalis fascia approach     versus the preperitoneal approach for inguinal hernia repair in residents from northern China     regarding common postoperative complications (including acute and chronic pain, wound     infection, rates of wound infection, hematoma, seroma, and hernia recurrence) and severe     postoperative complications.   "
22973|NCT02984904|"     The aim of this study was to describe the clinical-epidemiological characteristics of a     series of cases of fungal keratitis associated with Fusarium spp., In Spain during the years     2012 to 2014.   "
22974|NCT02984891|"     Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly     used and have been extensively studied separately to guide percutaneous coronary intervention     and improve long-term outcomes. In this study, the investigators aim to directly compare     high-definition IVUS images to OCT in the same patients to determine the differences between     each modality as they relate to imaging coronary pathology, with the goal of determining     which modality is most appropriate in particular clinical scenarios.   "
22975|NCT02984878|"     To compare improvement with retreatment for all subjects undergoing correction of nasolabial     folds (NLFs) in the initial SYM2014-02 study, who were retreated with Revanesse Ultra at     Visit 6/Week 24 and to determine the safety of repeat injections of Revanesse Ultra. The     retreatment phase was optional.   "
22976|NCT02984865|"     Gastrointestinal surgeries are common surgeries performed in elderly patients throughout the     world. Although there is an increasing trend towards laparoscopic surgeries, open procedures     continue to remain common therapeutic modalities especially in the developing countries. Pain     is reported more commonly in patients undergoing open procedures than laparoscopic     procedures. Postoperative pain and tissue injury associated with surgery initiated a systemic     stress response which has neuroendocrine, immunological, and haematological responses.     Opioids are an important modality of postoperative pain management. They blunt the     neuroendocrine stress response to pain. However, they are associated with several adverse     effects like respiratory depression, nausea, vomiting , pruritus, constipation, urinary     retension, bradycardia and hypotension. Transversus abdominis plane block（TAPB）is a relative     novel procedure in which local anesthetic agents are injected into the anatomic plane between     the internal oblique and the transversus abdominis muscle. It allows a significantly     prolonged duration of analgesia during the early postoperative stage in abdominal surgery.     This regional anesthesia technique provides analgesia to the skin, muscles of the anterior     abdominal wall and parietal peritoneum in order to decrease the incision-related pain. Thus,     it reduces postoperative opiate requirements and opioids-related side effects (nausea,     vomiting, delayed resumption of intestinal transit, drowsiness, respiratory depression, urine     retention). Nalbuphine, being mu antagonist an kappa agonist, has a ceiling effect in its     respiratory depression. Many studies have reported that incidence of adverse effects like     pruritus and PONV is lower with nalbuphine in comparison with morphine. The purpose of this     study is to compare the analgesic efficacy and side effect profile of sulfentanyl with     nalbuphine in elderly patients undergoing open gastrointestinal surgeries.   "
22977|NCT02984852|"     The purpose of this study is to evaluate the single-dose pharmacokinetics and relative     bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg,     Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a     fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as     Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed     as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test):     a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with     240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF (800/150/200/10     mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.   "
22989|NCT02984696|"     The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant     capacity, clinical, endocrine and metabolic features in women affected by hypotalamic     amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol     daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six     months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone     metabolism parameters are evaluated before and after therapy.   "
22978|NCT02984839|"     The aim of this prospective, observational study is to determine the incidence of     post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal     procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures     that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As     intra-abdominal surgeries are independently associated with post-operative pulmonary     complications (PPCs), it is important to highlight other factors, such as PRNB, that could     contribute to these complications.Although it has been shown that the risk of adverse     respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring,     such monitoring is not in widespread use.This study will incorporate quantitative monitoring     in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to     show a disparity in the incidence of residual paralysis between these two patient populations     and to emphasize the need to implement more accurate neuromuscular monitoring, especially for     those that are already at increased risk for respiratory complications.   "
22979|NCT02984826|"     Background:      Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance.     Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with     trapezius myalgia. It is shown that specific strength training leads to prolonged pain     relief.      Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients     with TTH compared to healthy controls.      Intervention: To investigate the effect of specific strength training on patients with TTH     compared with control group, receiving training in ergonomics.      Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and     shoulder. Testing conducted by blinded research assistant.      Intervention group: 60 patients with tension headache randomly assigned to the intervention     group or control group. Intervention with specific strength training program runs for 10     weeks. The control group will be trained in ergonomics. 3 months follow up.   "
22980|NCT02984813|"     This study is a multi-armed protocol designed to evaluate the safety and efficacy of two     different combinations of nutritional supplements (study drug) (Glauco-Health and     Glauco-Select) chosen for their potential to protect retinal ganglion cells against oxidative     stress, low-grade inflammation, and mitochondrial dysfunction in patients with open-angle     glaucoma and diabetic retinopathy. Oxidative stress and retinal cellular dysfunction will be     measured using a Retinal Metabolic Analyzer (RMA) in this randomized, single center, double     masked study. Patients with glaucoma will be divided into three treatment arms randomized to     receive either Glauco-Health, Glauco-Select, or placebo.   "
22981|NCT02984800|"     Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its     unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged     postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable,     timely and effective technique generates the investigation of a single PVB injection for     children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind     this investigation. First, possible spread of single PVB injection in the lumbar area over     dermatomes corresponding to the inguinal hernia region in children likewise the spread over     multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal     region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves,     all three arising from L1-L2 level; thus, a single PVB injection at this level could provide     unilateral segmental anesthesia.   "
22982|NCT02984787|"     The investigators will perform a prospective randomized comparison between 3D and 2D     laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.   "
22983|NCT02984774|"     The goal of the study was the detection of telomerase activity in eutopic, ectopic     endometrial tissue and in peripheral blood and finding the correlation between the telomerase     activity and clinic findings. With these results, confirmation of the hypothesis regarding     the endometriosis pathogenesis and endometriosis-related infertility was aimed.   "
22984|NCT02984761|"     Patients with stage I non-small cell lung cancer have been historically treated with surgery     whenever they are fit for an operation. However, an alternative treatment known as     stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors     believe both are good treatments and are therefore conducting this study to determine if one     may be possibly better than the other.   "
22985|NCT02984748|"     The ability to predict post-operative outcomes after implantation is important for a number     of reasons, including being able to advise candidates of appropriate expectations using     evidence based guidance. The approved study involves investigation of the ability to predict     outcomes in the implanted ear alone and in the best-aided binaural listening conditions,     examining a number of measured factors both pre-, peri- and post-operatively. The study     incorporates a range of functional outcome measures through questionnaires to ascertain     social, functional and demographic factors that may be predictive of outcomes. Questionnaires     are also administered to determine the degree of benefit obtained after implantation for each     individual, since this forms a key component of providing pre-operative counselling to     candidates.   "
22986|NCT02984735|"     The purpose of this study is to determine the association between gross motor function and     chewing performance level in children with cerebral palsy (CP). A cross-sectional study was     conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross     Motor Function Classification System (GMFCS) was used to determine gross motor function     levels of children. Chewing performance level was determined by using the Karaduman Chewing     Performance Scale (KCPS).   "
22987|NCT02984722|"     The aim of our study is to compare the different effects of 6 months treatment with     extended-release metformin and immediate-release metformin on clinical, endocrine and     metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate     gastrointestinal disorders associated with the two different compouds.   "
22988|NCT02984709|"     The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have     problems with adherence. The proposed study will pilot test a positive psychology     intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment     based on feedback from the first iteration of the intervention. The potential benefits     include helping adolescents achieve better glycemic control, thereby reducing the health     risks and complications associated with diabetes.   "
22990|NCT02984683|"     Primary Objective:      To select in the first part the SAR566658 dose based on Objective Response Rate (ORR) and     safety of 2 dose levels and to demonstrate in the second part the efficacy of the selected     dose based on ORR.      Secondary Objectives:        -  To assess:        -  Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS),          and Time To Progression (TTP)        -  The impact of ocular primary prophylaxis on the incidence of keratopathies;        -  The potential immunogenicity of SAR566658        -  To evaluate the global safety profile   "
22991|NCT02984670|"     The overall purpose with this investigation is to further our knowledge about cognitive     behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and     moderators. The first aim that will be addressed is to explore the efficacy of the CBT     components with a dismantling-treatment strategy. Two active CBT interventions, intended to     define its components - cognitive therapy and behavior therapy - will be compared with one     another as well as with a waitlist condition on a broad range of outcomes at five to nine     assessment points depending on the measures. The design will thus enable us to examine what     CBT component or components are necessary, sufficient and facilitative of therapeutic change.     The second aim that will be explored is to investigate what processes occur in CBT that may     contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for     CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep     Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep     Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed,     napping, bedtime variability, and rise time variability. The hypothesis is that cognitive     processes will mediate cognitive therapy outcomes, and that behavioral factors will have a     mediating role for behavior therapy improvements. The third aim that will be addressed is to     examine what patient characteristics does CBT depend on to be effective with a     treatment-moderator strategy. To investigate moderators for CBT, the following moderators     will be assessed; age, gender, occupational status, level of education, initial insomnia     severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical     co-morbidity, behavioral and cognitive processes used as mediators will also be employed as     moderators.   "
22992|NCT02984657|"     The purpose of this study is to investigate whether intraoperative reverse Trendelenburg     positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.   "
22993|NCT02984644|"     To determine the role of plasma glucagon and insulin in the rise of endogenous glucose     production (EGP) following the SGLT2 inhibition.   "
22994|NCT02984631|"     In patients with heart failure, elevated filling pressures may contribute to symptoms while     not improving cardiac output. The current study is focused on evaluating the relationship     between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of     dyspnea in patients with heart failure during exercise.   "
22995|NCT02984618|"     Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch     for post dural puncture headache but the investigators do not know if it has significant     efficacy when compared to epidural blood patch. Method: randomized trial where patients will     randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain     or low intensity pain will be the main outcome   "
22996|NCT02984605|"     This study evaluates the nutritional meal replacement and individualized exercise     prescription intervention on overweight and obese type 2 diabetes mellitus. Half of     participants will receive nutritional meal replacement and individualized exercise     prescription on the basis of conventional glucose-lowering treatment, while the other half     will only receive conventional glucose-lowering treatment.   "
22997|NCT02984592|"     Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such     as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and     their partners. The current study was aimed to evaluate the relationship between ejaculation     and physical activity.   "
22998|NCT02984579|"     This is a multi-center, blinded study to determine the performance of the YD Diagnostic     Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical     isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB)     and at risk of drug resistance. All testing was done on stored, de-identified leftover     samples.      The study involved three World Health Organization (WHO) Supranational Reference Laboratories     with well-characterized strain collections and access to sputum samples with significant     rates of drug resistance.   "
22999|NCT02984566|"     Primary and secondary liver cancer patients will receive liver SABR with or without KIM     intervention.   "
23000|NCT02984553|"     The purpose of this study is to accurately assess weekly physical activity levels of     postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.   "
23001|NCT02984540|"     The purpose of the BEAM study is to compare the effects of a low-carbohydrate diet and a     lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data collected     will help determine changes in cognitive function, brain structure and function, and levels     of certain proteins and hormones in body fluids.   "
23002|NCT02984527|"     The Purpose of the study is to compare the effectiveness on microbiological counts from skin     swaps after wash with water and soap or wet wipes.   "
23003|NCT02984514|"     Brown adipose tissue has the capacity to consume large amounts of energy and has     insulin-independent glucose uptake. The investigators have recently observed an inverse     correlation between irisin levels and insulin needs of type 1 diabetes patients.     Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood     glucose levels.      In this study 12 patients with long-standing type 1 diabetes (>10 years) and with variable     exogenous insulin needs will be investigated for amount of brown adipose tissue with positron     emission tomography using the tracer 18F-deoxy glucose.   "
23004|NCT02984501|"     There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic     disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease     with chemotherapy, as well as for the treatment of local disease with radiotherapy. The     investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin     and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy     in patients with borderline resectable and unresectable locally advanced pancreatic cancer   "
23005|NCT02984488|"     To evaluate the incidence and severity of postoperative pain after root canal therapy of     necrotic teeth in one appointment versus two appointments using Protaper next instrument.   "
23015|NCT02984358|"     Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption,     with or without a reduced nucleotide content, on markers of metabolic health, such as uric     acid concentrations, blood glucose control and blood lipid profiles.   "
23016|NCT02984345|"     The present study will seek to quantify the muscle protein synthetic response to mycoprotein     feeding, comparing it to milk protein as a gold standard and heavily researched positive     control   "
23006|NCT02984475|"     Beta Thalassemia is a major public health problem in Mediterranean countries.In Egypt, it is     considered as the most common chronic hemolytic anemia.one of the major complications in this     inherited disorder is iron overload which lead to oxidative stress and tissue damage.      Regarding toxic effect of iron overload on liver, hepatomegaly is one of the most findings     that resulting from hemosiderosis, extra medullary hematopoiesis, transmitted hepatitis B and     C and cirrhosis.      A lot of studies have been carried out recently to study the beneficial role of metformin in     non-diabetic patients of different disorders as non-alcoholic fatty liver disease     (NAFLD).Among several studies, it's demonstrated that metformin significantly improved     insulin resistance, aminotransferase levels and liver morphology.      The role of metformin in these studies is mainly thought to be antioxidant and     anti-inflammatory effects. However, the role of Metformin on hepatic function in different     populations with the same mechanism of liver injury should be further investigated.      This clinical trial will be carried out on 60 patients with beta thalassemia major receiving     regular blood transfusion and iron chelating therapy, either HCV positive or negative     patients.      They will be randomly distributed into either control group (group 1, n=30) receiving blood     transfusion and taking iron chelating therapy or treatment group (group 2, n=30) receiving     blood transfusion and taking iron chelating therapy along with metformin tablets (500     mg/twice daily) for 6 months.   "
23007|NCT02984462|"     The study is a prospective randomized study about hallux valgus surgery. The investigator try     to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an     incidence in the first ray mobility since the two technics ( fixation and no-fixation) are     described and practiced, and since the stiffness of the first metatarso-phalangeal joint is     determinant in the result of this functional surgery.   "
23008|NCT02984449|"     Rationale:      Patients undergoing cardiac surgery are at risk of developing perioperative complications and     major adverse cardiac events, mainly related to both their preoperative status and type of     surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective     therapy to prolong survival and improve quality of life. However, little is known about the     effect on post-operative complications, quality of life and return to work of a combined pre-     and post-operative CR program encompassing physical therapy, dietary counseling,     psychological support and life style management compared to a CR program, which is provided     only after cardiac surgery.      Objective:      to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to     three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction     in postoperative surgical complications, readmissions to hospital and major adverse cardiac     events in conjunction with improvements in the physical component of health related quality     of life), when compared to postoperative CR only (POST).      Study design:      A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized     between two standard care CR programs. One group will start a the POST CR program after     surgery. The other group will be randomized to a combined PRE+POST CR program.      Study population:      Patients (age > 18 years) admitted for elective coronary bypass surgery, valve surgery and/or     aortic surgery      Main study parameters/endpoints:      The primary outcome is a composite weighted endpoint of postoperative surgical complications,     re-admissions to hospital, major adverse cardiac events and health related quality of life     (two domains: physical functioning and physical problem), at three months and one year after     surgery. Endpoints are determined by an independent endpoint committee, blinded to the group     allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness,     muscle strength and functional status), psychological health (feelings of anxiety and     depression), work participation, economics, lifestyle risk factors (physical activity and     smoking behavior), self-efficacy and illness representations.   "
23009|NCT02984436|"     This is a prospective observational cohort study of ED patients with acute chest pain or     other symptoms suggestive of ACS. Blood samples will be collected from study participants for     High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for     research purposes only.      Providers will be blinded to results and participants will be treated by their healthcare     providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to     ascertain study outcomes.   "
23010|NCT02984423|"     This study aims to answer very important questions regarding the prevalence of somatic and     germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer     patients from Latin America. These answers may be extremely helpful in the counseling for     genetic risk and treatment approach in these populations and will aid in making treatment     decisions in the future   "
23011|NCT02984410|"     Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of     tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are     usually cured. Treatment of early stage OPSCC can be successfully achieved with primary     surgery including neck dissection, as indicated, or with definitive radiotherapy. The current     standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both     associated with comparable, high tumor control rates but with different side effects profiles     and technical constraints.      In order to decrease the potential morbidity of surgery, transoral approaches have been     developed within the last decades, including transoral robotic surgery (TORS), transoral     laser microsurgery (TLM)or conventional transoral techniques. On the other hand, patients     with head and neck cancer treated with IMRT experienced significant improvements in cause     specific survival (CSS) compared with patients treated with non-IMRT techniques thus     suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile.     It is as yet unclear however, which one of the new techniques is superior to the other in     terms of function preservation. Given that the functional outcome of most importance is     swallowing function, the preservation of swallowing is thus of major importance.      The main objective of the study is to assess and compare the patient-reported swallowing     function over the first year after randomization to either IMRT or TOS among patients with     early stage OPSCC.   "
23012|NCT02984397|"     Our goal is to conduct a proof-of-concept trial to test the efficacy of KF treatment in     adolescents with severe CWP not responding to the standard of care (SOC) treatment program in     a multidisciplinary tertiary care chronic pain clinic. The changes associated to the     interventions (KF or placebo) will be quantified using the Patients' Global Impression of     Change (PGIC) scale after 16 weeks of treatment. Secondary, we aim to evaluate the effects of     KF on the pain sensitivity, physical and emotional functioning, and we will also explore the     potential biological underlying mechanisms.   "
23013|NCT02984384|"     The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin     (LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots     in patients who sustain trauma.   "
23014|NCT02984371|"     The aim of this prospective randomized study was to assess the efficacy of ablation of the     ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial     tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery     bypass grafting.   "
23017|NCT02984332|"     The effect of unilateral lower limb immobilisation over one week on muscle atrophy   "
23020|NCT02984293|"     Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe     drugs. However, up to one third of statin users can experience muscle symptoms, which are     most commonly mild without any conventional laboratory signs of muscle damage. However, these     muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy,     reducing its effectiveness. Recent data has highlighted the potential role of immune system     in development of statin-induced muscle pain. Variation in the LILRB5 gene has been     associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic     variability in tolerability and immune response to atorvastatin in healthy volunteers.      The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in     Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE     study. The participants will be healthy, and recruited according to their genotype of LILRB5     (information available from GoSHARE). The volunteers will then enter a randomised cross-over     study with two treatment periods. During treatment period one, all participants will be     commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment     period, blood and urine samples will be taken and a muscle symptoms questionnaire will be     completed to assess the tolerability and immune response to the study drug exposure. After     four weeks, the study drug is stopped for a washout period of three weeks before cross-over     commences. Thereafter, during treatment period two, the alternate study drug will be started,     and tolerability will be assessed similar to that in period one. The study will last     approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.   "
23021|NCT02984280|"     This study will investigate whether there is a population-level association between     circulating respiratory viruses and NHS hospital admissions for acute vascular events using     data from national infection surveillance and Hospital Episode Statistics.   "
23022|NCT02984267|"     Placement of labor epidurals is a very common daily practice in obstetrical anesthesia.     Currently, these epidurals are placed based upon palpation of landmarks to determine midline     and the correct spinal level for placement. Palpation of these landmarks can be difficult,     however, particularly in morbidly obese patients who have significant amounts of soft tissue     overlying them. This study seeks to use ultrasound guidance to examine the spine prior to     epidural placement, and see what effects this has compared to palpation alone with respect to     procedure time, number of attempts, success rate in the first attempt, failure rate,     complication rate, patient anxiety levels, and patient satisfaction levels.   "
23023|NCT02984254|"     BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has     received relatively little attention in the OA literature and there are few treatment options     for individuals with patellofemoral OA. Patellar misalignment is associated with radiographic     progression patellofemoral OA and symptoms and in magnetic resonance imaging (MRI), to     cartilage loss measurements and bone marrow lesions. The hypothesis is that the correction of     the patella disorder using strategies such as bracing or adhesive bandages can handle the     symptoms and progression of OA.      OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint     compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA.      METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of:     overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will     be divided into two groups according to the knee brace that will receive: Functional Bracing     patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both groups     will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome and asked     to do daily exercises in addition to reporting the daily consumption of drugs a month before     placing the orthotics up to three months after placing it. They will be evaluated with the     questionnaires WOMAC and Lequesne, and asked to perform the five-times-sit-to-stand-test,     Timed-up-and-go (TUG) and the six-minute walk test in the moments immediately prior to     placement of the brace, with one, three and after 12 months bracing.   "
23024|NCT02984241|"     This study evaluates web-based interventions to help women cope with the stress arising from     living with a problem-drinking partner   "
23025|NCT02984228|"     Glenohumeral osteoarthritis (OA) accounts for approximately 2-5% of all chronic shoulder pain     and may be classified into primary and secondary forms. Primary glenohumeral OA is caused by     degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary     to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative     changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in     synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory     properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains     growth factors that have been shown to promote tissue regeneration. The aim of this study is     to determine whether injections of hyaluronic acid or platelet-rich plasma can be used     reliably to decrease pain, restore function, and improve quality of life in patients     suffering from glenohumeral OA. Patients will be randomized to receive either an injection of     hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via     questionnaires for up to 24 weeks post-procedure.   "
23026|NCT02984215|"     Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic     PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date,     there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report     array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.   "
23027|NCT02984202|"     The objectives of the clinical study are to implant five deaf patients (those with     Neurofibromatosis Type II, NF2) with a new two-shank auditory midbrain implant array (AMI;     developed by Cochlear Limited) into the central nucleus of the inferior colliculus in order     to assess the safety, reliability, consistency of placement, and performance of the AMI     device. The clinical trial is being performed at Hannover Medical School in Germany in     collaboration with University of Minnesota (USA) and Cochlear Limited (Australia). The     clinical trial is being managed by Hannover Clinical Trial Center in Germany.   "
23028|NCT02984189|"     Introduction: The inspiratory muscle training (IMT) has showed great benefits to the     respiratory, autonomic system, and mainly to the improvement of physical performance in     healthy subjects. The latter is related to the improvement of respiratory muscle strength,     decreased of dyspnoea, peripheral fatigue and delay in activation of muscle metaboreflex     during exercise. However, there is no consensus about the best training load to IMT, because     the prescription has been done only using percentage of the maximal inspiratory pressure     (MIP), and 60% of MIP has been the most used. Therefore, the IMT prescription protocol that     takes into account the respiratory muscle strength and endurance can provide additional     benefits to protocols commonly applied, once that respiratory muscle differs from the other     muscles due to its greater muscle endurance. In the sense, the IMT using inspiratory critical     pressure (PThC) comes up with an alternative, since the PThC calculation considers these     characteristics. Objective:To evaluate the effect of the IMT, using PThC, on cardiovascular,     respiratory, metabolic and autonomic responses in recreational cyclists and compare it to a     IMT using 60% of MIP. Methods: Thirty men recreational cyclists (20-40 years), will be     randomized to placebo group (PG, n = 10), PThC group (PTHCG, n = 10) and 60% of MIP group     (60G, n = 10), taking into account the age and functional aerobic capacity. All subjects will     perform the following evaluations: cardiovascular autonomic tests [heart rate variability     (HRV) and blood pressure variability (BPV) at rest and after active postural change],     pulmonary function testing, respiratory muscle strength (RMS) test, cardiopulmonary exercise     testing (CPET), incremental respiratory muscle endurance test (iRME) [maximum respiratory     pressure sustained for 1 minute (PThMAX)] and constant respiratory loads test (95%, 100% and     105% of PThMAX), both using an linear inspiratory load resistor (PowerBreathe K5). The PThC     will be obtained from the linear regression using the time(TLIM) of and load of each constant     test (95%, 100% and 105% PThMAX). During evaluations, the ECG (BioAmp FE132), blood pressure     (BP), using Finometer Pro (Finapress Medical Systems) and respiration (Marazza) signals will     be acquired. The signals will be coupled by data acquisition and analysis device (Power Lab     8/35) and sampled at 1000 Hz. Moreover, the oxyhemoglobin, deoxyhemoglobin and total     hemoglobin responses will be measured by near-infrared spectroscopy (NIRS) (Oxymon MKIII),     sampled at 250Hz. The IMT will be performed for 11 weeks (3 times/week, 1-hour duration). The     session will consist of 5-min warm-up (50% of the training load) and 3 sets of 15 minutes     (breathing against 100% of the training load) with 1-min interval between them. Heart rate     and BP will be monitored in all training sessions. The RMS, iRME, respiratory constant load     tests and CPET will be performed before and after the training, and in the 3rd and 7th week     (for training load adjustment). The pulmonary function testing and the cardiovascular     autonomic tests will be performed only before and after training. The data will be analyzed     by specific statistical tests (parametric and nonparametric) according to the data     distribution and their respective variances. Significance will be set at p<0.05. Expected     results: It is expected that the training performed by PTHCG, when compared to training     performed by 60G and PG, promotes: greater improvementin workload (Watts) and peak oxygen     uptake (VO2peak); increasing in MIP and iRME; decreasing of dyspnoea and peripheral fatigue;     delay in activation of muscle metaboreflex in the CPET and iRME; improvement incardiac     parasympathetic autonomic modulation and reducing cardiac and peripheral sympathetic     modulation. Moreover, it is expected that the results can provide information for a better     understanding of the responses obtained by the PThC training in the different evaluated     systems. In addition, these results will allow the use of this method by health professionals     as a new assessment tool and IMT prescription.   "
23029|NCT02984176|"     Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and     abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.      The investigators objective is to evaluate the efficacy and safety of preoperative oral     simethicone for bowel preparation in gynecological laparoscopies.   "
23036|NCT02984085|"     Prospective open-label, uncontrolled clinical study to assess the safety and efficacy of     autologous cultured epidermal grafts containing epidermal stem cells genetically modified     with the aid of a gamma-retroviral vector carrying COL7A1 complementary DNA (cDNA) for     restoration of the epidermis in patients with recessive dystrophic epidermolysis bullosa. The     purpose of this study is to demonstrate the safety and efficacy after one or more treatments     with genetically corrected cultured epidermal autograft (Hologene 7) in patients suffering of     recessive dystrophic epidermolysis bullosa (RDEB) with COL7A1 mutation.   "
23037|NCT02984072|"     Topical photodynamic therapy (PDT) is widely used to treat superficial non-melanoma skin     cancer (NMSC) and dysplasia, notably actinic keratosis and may also be effective in a range     of other dermatological conditions. A major limitation of PDT is pain during irradiation. A     lack of knowledge of the mechanism of PDT-induced pain has limited the development of     effective approaches for prevention or relief of this adverse effect. The investigators have     investigated the possible efficacy of menthol for PDT pain ex vivo and will now study this in     a clinical trial. This proposal describes the prospective randomised double blind, placebo     controlled clinical trial that will be undertaken to investigate the use of topical menthol     for PDT-induced pain relief in patients with actinic keratosis of the face and scalp who will     be attending general dermatology and PDT outpatient clinics at Ninewells Hospital, Dundee.   "
23038|NCT02984059|"     To characterize persistent abdominal pain in children with inflammatory bowel disease (IBD)     by examining factors such as disease type, activity and location, psychosocial factors, and     genetics.      The investigators hypothesize that by using patient pain and psychological assessments in     addition to analysis of blood, stool and colonic biopsies, we can better characterize factors     that predispose children and adolescents with IBD to have persistent and/or disproportionate     abdominal pain.   "
23039|NCT02984046|"     Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.      Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of     epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7     months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and     secondarily for the development of asthma.      Two other markers of airway aggression seem to increase during acute bronchiolitis: serum     SP-D protein and serum soluble receptor sRAGE.   "
23040|NCT02984033|"     The prospective trial is to describe the quality of life and psychological effects in     patients with head and neck tumor receiving curative intent treatment   "
23041|NCT02984020|"     The objective of this study is to identify any problems and questions with respect to the     safety and efficacy of Xeljanz during the post-marketing period as required by the regulation     of MFDS.   "
23042|NCT02984007|"     Synopsis: In most countries, there is an increase in the number of parents who refuse some,     most or all vaccines or who adopt delayed vaccination schedule. Vaccine hesitancy (VH) is a     global phenomenon that needs to be measured and addressed. However, to this date, no     effective strategy has been identified. Dr Gagneur have developed and validated a new     approach to educate parents of newborns about vaccination, based on motivational interviewing     (MI) techniques. MI is a method to elicit and strengthen motivation for change based on the     person's own arguments for change that has been shown effective for the adoption of many     preventive health behaviors. This approach has been validated for vaccination during a pilot     study as well as in a provincial RCT in Quebec. Now that a proof of concept has been made in     Quebec, the investigators will validate the approach in other contexts (e.g. English-speaking     provinces and settings with different ways to deliver maternity care and childhood vaccines).      Hypothesis: An educational strategy, based on MI techniques, delivered in the maternity ward     increases parents' intention to vaccinate their infant, reduces VH scores and increases     infants' vaccine uptake in Quebec. This approach may be applicable across the country in     order to tackle VH and thus improve infants' vaccine coverage (VC).      Objective: To evaluate the impact of the MI intervention on parents' intention to vaccinate     their child and their VH score and on infants' VC at 3 months of age, in a pan-Canadian     context.      Methods: Multicentre RCT in maternity wards of 5 provinces (QC, BC, ON, NS/PE). Parents will     be randomized to receive the MI intervention (intervention group) or to receive an     information flyer on vaccines (control group). MI intervention will be delivered by research     assistant that will have first received a standardized training session on the content and     techniques of MI. Parents will complete a self-administered questionnaire to measure     knowledge and vaccination intention as well as VH before and after the intervention.     Immunization data will be collected through an online questionnaire sent when the child will     reach 3 months of age.      Expected benefits: The strategy will be validated across different immunization programs from     5 Canadian provinces to take account of the differences in logistics and cultural contexts.     Results from this study will provide to the provincial and national public health authorities     an effective strategy to tackle VH.   "
23043|NCT02983994|"     The aim of the study is to evaluate the errors that may occur during inhalation of two     devices in patients with asthma, as well as to study whether it relates to the degree of     control of patient symptoms and the degree of compliance of medication symptoms. Finally, we     also want to study the degree of patient satisfaction with each of the inhalers studied   "
23044|NCT02983981|"     A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of     Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who     are receiving biologic therapy for at least 24 weeks   "
23056|NCT02983825|"     Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs     open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas     of the lung that are open for gas exchange do not match up with the areas of the lung that     are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch     to changes in the amount (or level) of CPAP.   "
23057|NCT02983812|"     In this study, patients will be prospectively enrolled for data collection to design     prediction models that integrate claims data (inpatient, outpatient, and pharmacy),     electronic health record data (on clinical, social, and behavioral indicators), and     patient-generated activity data. Patients will be randomized to use either a smartphone or a     wearable activity tracking device to capture patient-generated health data.   "
23058|NCT02983799|"     This is a non-randomized, open-label study to assess olaparib tablets as a treatment for     subjects with different homologous recombination deficiency (HRD) tumor status and with     platinum-sensitive, relapsed, high-grade ovarian cancer. Subjects should have received at     least 2 prior lines of platinum-based chemotherapy.   "
23059|NCT02983786|"     The goals of the project are to evaluate a noninvasive monitor of brain metabolism and blood     flow in critically ill humans. If validated, such a reliable noninvasive brain blood flow and     metabolism monitor, by allowing physiologic and pharmacologic decisions based on real-time     brain physiology, potentially will become an important tool for clinicians in their efforts     to prevent additional brain tissue death in patients admitted with stroke, brain hemorrhage     and traumatic brain injury.   "
23045|NCT02983968|"     Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the     world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).     This cancer is closely associated with the presence of chronic liver underlying disease and     early diagnosis following a systematic surveillance of cirrhotic patients could improve     disease-free survival in patients declaring HCC. However, the risk-benefit ratio of such     monitoring is discussed. Nevertheless, it is recommended in patients with liver cirrhosis,     from which the prevalence is estimated between 0.3% and 0.6% in the French population. This     debate can lead to a failure to comply with recommendations and promote a large variability     in the management of the surveillance of HCC in patients with cirrhosis in practice. Data     acquisition regarding the current situation in France is required.      The objective of this project is to use this database to document current practices     concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective     cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The     primary analysis will focus on multivariate modelling of the deviation rate from the     recommendations (advising the realisation of at least two echodoppler ultrasonographies     yearly) with a competitive risk model, taking into account gender, social status, Charlson     index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly     number of visits to a hepatologist during follow-up. It is estimated that more than 86,000     patients with a minimum follow-up of 3 years will be included in the analysis   "
23046|NCT02983955|"     The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting     to standing and standing to sitting. The product provides indoor and outdoor mobility.      The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as     an outdoor and indoor mobility device by individuals with walking impairment.   "
23047|NCT02983942|"     Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high     glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic     diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous     system lymphoma (PCNSL).   "
23048|NCT02983929|"     The main purpose of this study is to determine the influence of obesity on the short term     follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee     arthroplasty. It is a retrospective, comparative study      The secondary purposes are to explore the links between length of stay and short-term     follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee     arthroplasty.   "
23049|NCT02983916|"     Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery,     affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases,     suggesting that adhesiolysis can play an important role in the management of such pain.     Despite initial promising results regarding the effect of adhesiolysis on post-operative     pain, implementation of the procedure has been challenging. The major problems associated     with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high     rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However,     diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI     techniques, and with application of anti-adhesion barriers following adhesiolysis.      In this study the investigators evaluate a new practice-based approach to the problem of     chronic post-operative pain caused by adhesions. This practice-based approach includes use of     a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI holds     promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk for     bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the     investigators attempt to prevent adhesion reformation and improve long-term outcomes of     adhesiolysis.   "
23050|NCT02983903|"     Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is     to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients     at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung     biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients     enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies     for their lung lesion during bronchoscopy.   "
23051|NCT02983890|"     This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence,     two-period crossover, cocktail study where a combination of cocktail-drugs is used to     illustrate whether or not, or to what degree dicloxacillin affects the level of activity of     the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious     drug-drug interactions.   "
23052|NCT02983877|"     This study will test an adherence intervention (iTAB-CV) delivered via interactive text     messaging which first targets behavioral intent and then adds cues/reminders and     reinforcement to form the habit of taking antihypertensives in non-adherent individuals with     BD. Thirty eight individuals with BD and HTN being treated with evidence-based     antihypertensive agents and mood stabilizing or antipsychotic medications who are     non-adherent with their HTN medicine will be enrolled.      This study uses a prospective cohort design with participants serving as their own control.     Investigators will test the iTAB-CV intervention quantitatively for feasibility and     acceptability as well as for efficacy in increasing adherence to antihypertensives,     decreasing systolic blood pressure, and increasing adherence to BD medication.   "
23053|NCT02983864|"     The objective of the proposed project is to conduct a randomized controlled trial (RCT)     comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape     myth acceptance) for men who receive a group alcohol intervention only to men who receive a     group integrated alcohol and sexual assault intervention.   "
23054|NCT02983851|"     VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying     the initial ventilation strategy for adult immunocompromised patients with acute respiratory     failure.   "
23055|NCT02983838|"     Target of the research Based on change of Brain-derived neurotrophic factor and other     pro-inflammatory cytokine along with symptom improvement following treatment, the     investigators are trying to find the new treatment target molecule. The investigators will     follow up the subjective and objective cognitive dysfunction with psychiatric symptom     profiles and compare the neuroimaging related to these change.   "
29695|NCT02896985|"     This is a multi-center study that explores the relationship between recapture of response     with escalation to weekly adalimumab and trough adalimumab concentration before escalation in     patients experiencing lack of response (LOR).   "
23060|NCT02983773|"     This laboratory study will employ a repeated measures experimental design to examine the     effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on     alcohol craving and on behavioral economic measure of alcohol demand after exposure to     alcohol cues, and on subsequent drinking in an alcohol choice task in which participants     choose either to drink or receive monetary reinforcement for drinks not consume. The study     will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at     least twice weekly.   "
23061|NCT02983760|"     Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes     patient to the risk of potentially fatal recurrence. False positive testing exposes patients     to potentially fatal unduly side effects of anticoagulants.      Current diagnostic strategies rely on the sequential use of pretest clinical probability,     Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE     diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan.     Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore     requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA     are its higher radiation dose and contraindications (renal failure).      In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30%     increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis     of over-diagnosing and over-treating PE when using CTPA.      V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has     been reported to improve the diagnostic performances of the test, which could reduce the     number of non-conclusive tests and allow simplified diagnostic algorithms.      The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to     the two usual approaches responding rightly to the two mains issues and combining the     advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower     radiation exposure, no contraindication).      Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT     rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which     diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q     SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic     exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated     strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.   "
23062|NCT02983747|"     The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma     (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce     the pain feeling and benefit for restore of the intervertebral disk.   "
23063|NCT02983734|"     The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for     Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic     health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf     War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of     Gulf War Illness. By using the literature of previous studies, the investigators have chosen     to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive     symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and     improve synaptic functioning in key areas of the brain.   "
23064|NCT02983721|"     The purpose of this study was to assess and compare the feasibility, success and safety of     Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic     coronary angiography and coronary interventions, in terms of procedural time, access time,     fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital,     Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of     vessel, MACE, Stroke and others.   "
23065|NCT02983708|"     The current study describes a randomized, double-blind, cross-over study of intravenous G-CSF     followed by infusion with autologous mobilized peripheral blood mononuclear cells (mPBMCs) in     children with cerebral palsy (CP) to determine the safety and feasibility of the procedure,     as well as the potential efficacy for improving neurological impairment.   "
23066|NCT02983695|"     This is a Phase 1 trial to determine the tolerability and optimal dose of CBD rich cannabis     extract as an adjunct treatment in children with severe drug resistant epilepsy due to Dravet     Syndrome. This is an open label intervention. Study duration is 20 weeks to primary analysis     with continued follow-up until 64 weeks completed.   "
23067|NCT02983682|"     This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic     pain in children. All participants will receive lidocaine infusion and severity of pain and     degree of chronic-pain related disability will be assessed before and up to 4 weeks after     infusion. Adverse events will be recorded.   "
23068|NCT02983669|"     The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria     multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease     (NAFLD).   "
23069|NCT02983656|"     The purpose of this study is to observe the occurrence of adverse events of live attenuated     varicella vaccine.   "
23070|NCT02983643|"     Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes     and disclose malnutrition risk effectively. The aims of the study are to assess prevalence of     malnutrition in patients planned for SCT, to characterize changes in body composition (SMI,     total adipose tissue and VAR) that occur in the peri transplantation phase, and to identify     Waist Circumference (WC) cut off points associated with the metabolic syndrome (MetSyn) in     patients with B and T cell Lymphoma.   "
23116|NCT02983045|"     This study is to determine first, the recommended Phase 2 dose of NKTR-214 when administered     in combination with nivolumab, and then, the clinical benefit, safety, and tolerability of     combining NKTR-214 with nivolumab in select patients with melanoma, renal cell carcinoma or     non-small cell lung cancer. Both drugs target the immune system and may act synergistically     to promote anti-cancer effects.   "
23071|NCT02983630|"     Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as     penicillin allergic is associated with increased health care costs, adverse effects and     antibiotic resistance. The investigators will recruit participants from primary care     practices labeled as penicillin allergic and offer allergy testing. The aim of this study is     to develop a community, outpatient program for evaluation of penicillin allergy.   "
23072|NCT02983617|"     The objective of this study is to determine the preliminary efficacy and safety of the     combination of tirabrutinib (formerly GS-4059) and entospletinib with and without     obinutuzumab in adults with relapsed or refractory chronic lymphocytic leukemia (CLL).      The primary objective is evaluation of efficacy with the secondary objective evaluation of     safety and evaluation of additional parameters of efficacy. The treatment period is adaptive,     with a duration of active treatment up to two years and a total follow-up on study of 5 years     for time-dependent outcome variables. The study has a 6 patient per arm safety run-in to     evaluate safety prior to the enrollment of subsequent participants.   "
23073|NCT02983604|"     The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize     the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant in women     with advanced estrogen receptor positive Her2-negative (ER+/HER2-) breast cancer and to     determine the maximum tolerated dose (MTD) (if not already determined) or the recommended     dose for the Phase 2 part of this study.      The primary objectives of the Randomized Phase 2 Dose Expansion portion of this study are to     evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant     alone in women with advanced ER+/HER2- breast cancer.   "
23074|NCT02983591|"     The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use     in the third stage of labor ineffective in reducing post partum blood loss as compared to     other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in     reducing post partum hemorrhage.   "
23075|NCT02983578|"     The goal of this clinical research study is to learn if AZD9150 given in combination with     MEDI4736 (durvalumab) can help to control advanced pancreatic, lung, or colorectal cancer.   "
23076|NCT02983565|"     Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some     patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia)     especially during sleep which may be harmful. In order to overcome this, the investigators     have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which     automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on     oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent     intermittent hypoxia during sleep in patients already on long-term oxygen.   "
23077|NCT02983552|"     The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5     days per week plus spectacle correction with spectacle correction only, for treatment of     amblyopia in children 4 to <13 years of age.   "
23078|NCT02983539|"     The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and     10% in children. Even though it is a rare cancer, it contributes to a significant loss of     years of life in comparison with other types of cancer, due the fact that it affects children     and young people. The diagnosis and treatment are difficult, considering the diversity and     rarity of this disease. In addition, on average, more than 50% of patients with high-grade     sarcoma present tumor relapse and distant recurrence is considered the main cause of death.     The presence of Circulating Tumor Cells (CTCs) in the blood of patients with sarcoma may be     an early marker of tumor invasion, because it is known that the CTCs circulate in the blood     for months or years before the development of metastases. The CTCs can be used to monitor the     response of the tumor to treatment, in order to match time, dose, and type of therapy.      Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma,     synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify CTCs.     The investigators also have an intention to identify genes of resistance to treatment in     these cells.   "
23079|NCT02983526|"     80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis     were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden.     The patients were randomized to either CFP or Corail stem, both groups received Delta cup     from Lima. Randomisation was done using envelopes. Patients could only participate with one     hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.   "
23080|NCT02983513|"     Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period     of stressful environment, which may negatively impact early brain development and subsequent     neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in     reducing stressful experiences early in life and in enhancing brain development and long term     developmental outcomes.   "
23081|NCT02983500|"     Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.   "
23082|NCT02983487|"     Due to waning of infectious as well as vaccine immunity and lack of vaccination boosters, a     large number of adolescents and adults are no longer immunized against Bordetella pertussis,     the agent of whooping cough and consequently may contract whooping cough. Furthermore, these     populations represent a reservoir of the infectious agent from which the dissemination to     non-immune infants is possible, causing severe illness, or even death, in this age group.      Few studies have been carried out on whooping cough in developing countries (incidence,     contaminator's age, etc.) and, specifically, none have assessed the duration of protection     induced by the whole cell pertussis (wP) vaccine mainly presently used in these countries.      However, data on the duration of vaccine induced protection are essential to determine i) the     usefulness of vaccine boosters and ii) the target age group for these boosters.      The aims of the present study are:        -  To evaluate the proportion of confirmed pertussis cases in infants presenting whooping          cough syndrome (WP1a)        -  To evaluate the proportion of confirmed pertussis cases or healthy carriers among          contact cases        -  To determine origin of the infant's contamination (WP1b)        -  To determine the duration of protection induced by the wP vaccines used in contact cases          and the child population aged 3 to 15 yo (WP1b and WP2)        -  To bring new scientific evidences documenting the potential need for initiating boosters          (WP1b and WP2)        -  To allow a comparison of the results with those obtained using the same methodology for          the acellular pertussis vaccine and/or in other contexts. Potential implications for the          use of pertussis vaccines in low and moderate income countries.        -  To increase local capabilities by the transfer of materials and expertise that will make          the diagnosis of pertussis possible in the centres of reference and strengthen a          pertussis monitoring network in the implicated countries.        -  To improve children's health through a better match of the vaccination schedule          according to the reality of the situation.   "
23143|NCT02982694|"     The primary objective of this study is to determine the anti-tumor activity, as measured by     overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with     chemotherapy resistant CRC and positivity for MSI-like molecular signature. This is an     international, open-label single arm (non-randomized), one-stage phase II trial.   "
23083|NCT02983474|"     The member of National Evidence-based Healthcare Collaborating Agency and the planning     committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol     of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American     College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National     Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values,     operation finding, general occurrences, postoperative occurrences, and follow-up data to     develop post cholecystectomy complication risk model.      The 50 surgeons from 20 hospitals have decided to participated in the primary prospective     study to apply KSQIP to cholecystectomy. The investigators developed web-based database     system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill     out the case report form. Finally, the investigators will provide a risk-adjusted surgical     risk calculator and feedback system for reducing complication.   "
23084|NCT02983461|"     The investigators goal is to develop medical treatments for stress/mixed urinary     incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and     strength and to decrease muscle fatigue. The investigators believe that it will improve     muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related     to pelvic floor dysfunction.   "
23085|NCT02983448|"     This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation     (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients     will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but     the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or     sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation     (TENS) device with electrodes attached to the tragus of the ear, which is innervated by     auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of     LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for     HRV analysis every 15 minutes of stimulation (total of 4 recordings).   "
23086|NCT02983435|"     The relevance of this study is to determine the efficacy of two osteopathic techniques -     Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component     of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Few     studies have investigated and compared the physiological responses of these techniques     quantitatively, and no published study has compared their effects in low back pain subjects     in terms of symptoms, postural balance and muscle activation. The main outcomes will be     computed by electromyography measurement so that to assess the trunk neuromuscular activation     pattern as well as by force platform parameters for determining of postural control. Clinical     symptoms such as pain intensity, perception of disability and fear and avoidance will also be     computed.      This is the first study to compare these two osteopathic techniques using the main biological     outcomes related to trunk neuromuscular function.   "
23087|NCT02983422|"     This study evaluates the effects of aminophylline on serum creatinine and urine volume of AKI     Patient.Half of participants will receive aminophylline and furosemide in combination,while     the other half will receive only furosemide.   "
23088|NCT02983409|"     This is an observational study based on retrospectively collected data of ureter stone     patients between 2011 and 2014. Aim of study is to determine radiologic findings of     non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect     ureter stone patients in emergency department (ED).   "
23089|NCT02983396|"     Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial     infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary     syndromes. The Mini RELF device is a hand held self applicable device intended to detect on     an individual basis an elevation of the ST segment that is indicative for an acute coronary     occlusion. The investigators aim to evaluate the accuracy of Mini RELF device when it is     self-applied on a daily basis by patients with coronary artery disease.   "
23090|NCT02983383|"     TAP block is the administration of local anesthetic agents into the anatomic neurofascial     cavity between the internal oblique and transversus abdominis muscle in the antero-lateral     region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and     first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We     aim to show the effect of TAP block administration on analgesic consumption after     varicocelectomy operations, side effects linked to analgesic use and analgesic quality.   "
23091|NCT02983370|"     The objective of this study is to evaluate the usefulness of a cortical visual prosthesis     based on intracortical microelectrodes to provide a limited but useful sense of vision to     profoundly blind. This pilot study will provide important information on safety and efficacy     for the development of an useful cortical visual neuroprosthesis for the blind.   "
23092|NCT02983357|"     The purpose of this study is to investigate if the use of autologous bone graft around the     anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography     scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.)     better functional outcomes. Investigators hypothesize that a glenoid anchor peg component     fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a     lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate     with excellent shoulder function. Glenoid component loosening remains a major concern     following total shoulder arthroplasty and is the man reason for failure. Despite positive     findings in the investigators previous study (same population at a minimum of 2 year post     operative follow up), it is reasonable that loosening rates could increase with longer     follow-up. This study will be a minimum of 7 year post operative follow up.   "
23093|NCT02983344|"     This study is performed to determine the efficacy of ultrasound-guided fascia iliaca     compartment block during positioning for spinal anaesthesia in patient undergoing repair of     proximal femur fracture surgery comparing with intravenous fentanyl.   "
23094|NCT02983331|"     In this study, the investigators aimed to overview patients with specific and non-specific     complications who admitted to intensive care unit following endoscopic retrograde     cholangiopancreatography and had fatal course in the facility   "
23186|NCT02982135|"     The investigators conducted a prospective multi-center study assessing the effect of direct     bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.   "
23096|NCT02983305|"     The goal of this study is to examine the ability of optical head‐mounted display technology     to enlarge the visual field of patients with severe visual field loss due to retinal     dystrophy and to improve mobility and patient‐reported outcomes.   "
23097|NCT02983292|"     The study is designed as a single center, post-market, non-randomized, open-label,     observational clinical study with retrospective and prospective enrollment to evaluate the     2-year post implantation survivorship of the PyroTITAN™ HRA device following the     implementation of a new proof test to identify and eliminate devices with sub-standard     mechanical integrity.   "
23098|NCT02983279|"     The purpose of this trial is to determine that sort term calorie restriction will affect     tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively     impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.   "
23099|NCT02983266|"     The purpose of this research device study is to learn more about the autonomic nervous     system. This system uses nerves to send information from the brain to the rest of the body by     electrical signaling and has two divisions, the sympathetic and the parasympathetic branches.     It has been thought that electrical stimulation devices could be used to restore balance to     the nervous system. Because most of the imbalance seems to happen due to too much sympathetic     activity, the investigator plans to focus on the parasympathetic branch. Specifically, the     investigator hopes to restore balance by targeting the vagus nerve, which is the main     communicator of the parasympathetic branch. The study will examine whether the investigator     can decrease sympathetic activity and chronic inflammation by increasing parasympathetic     activity. This is a device study that will examine the use of non-invasive vagal nerve     stimulation to attenuate inflammatory stress and sympathetic hyperactivity in persons with     Spinal Cord Injury and Non-Disabled Controls.   "
23100|NCT02983253|"     Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an     inherited multisystemic disorder. Literature suggests that HHT is often associated with     higher frequency of infectious diseases.      The purpose of this study is to evaluate a variety of immunologic parameters in the blood     serum of HHT patients in comparison to probands.   "
23101|NCT02983240|"     The purpose of this study is to explore a new method to stop preterm uterine contractions     using an electrical device. The device, an electrical pacemaker for the uterus, has been     approved by the Food and Drug Administration (FDA) for clinical research in pregnant women.     The purpose of this study is to evaluate the feasibility and safety of the device. The     investigators hypothesize that human preterm uterine contractions can be safely and     objectively inhibited with a weak electrical current provided by an electrical inhibition     (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI     exposure.   "
23102|NCT02983227|"     This is a Phase II, multicenter, open-label extension study to evaluate the long-term safety     and efficacy of GDC-0853 in participants with moderate to severe active RA who have completed     12 weeks of study treatment in Study GA29350 (NCT02833350). Eligible participants from Study     GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an     open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.   "
23103|NCT02983214|"     Investigation of the clinical efficacy and safety of dual antiplatelet therapy with     clopidogrel and cilostazol versus clopidogrel alone in preventing ischemic vascular events in     patients with type 2 diabetes and symptomatic peripheral arterial disease.   "
23104|NCT02983201|"     The objective of this trial is to further confirm and assess the efficacy of filiform needle     therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack     needle therapy could further enhance the clinical efficacy and pain healing effect of the     filiform needle therapy.   "
23105|NCT02983188|"     One double-blind, randomized, placebo-controlled trial is designed to examine whether     berberine added to current antipsychotic drugs could produce significantly greater efficacy     in reducing atypical antipsychotic-induced metabolic syndrome. To achieve this objective, 120     patients with schizophrenia spectrum disorders (SSD) who have developed metabolic syndrome     will be recruited and randomly assigned to receive additional treatment with placebo (n = 60)     or berberine (n = 60, 1.2 g/day, 0.4 g, t.i.d.) for 12 weeks. The primary outcome is weight     gain; other outcomes include body mass index (BMI), waist circumference, blood pressure,     triglycerides (TG), total cholesterol, high-density lipoprotein (HDL), and low-density     lipoprotein (LDL), fasting glucose, insulin, and insulin resistant index.   "
23114|NCT02983071|"     This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in     combination with fulvestrant in patients with hormone receptor-positive, HER2-negative     metastatic breast cancer.      The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and     expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment     Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with     study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will     be enrolled in the study.   "
23115|NCT02983058|"     The primary goal of the present study is to evaluate the utility of mGluR5 binding as     measured by PET as biomarker of the CNTNAP2 mutation and related mTOR kinase pathway     dysregulation.   "
30377|NCT02888106|"     Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in     Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with     Chronic Viral Hepatitis B with Delta-agent   "
23106|NCT02983175|"     Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of     gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during     anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol     qualified full stomach whatever the patient and the preoperative fasting period are. This     protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or     rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk     than others. Ultrasound assessment of gastric content before rapid sequence induction of     anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside     technique. Furthermore, the correlations between gastric volume and risk of a full stomach     and also between the cross-section antral area (CSA) and the risk of a full stomach have been     validated on several patient cohorts. We formulate the hypothesis that the achievement of a     gastric ultrasound before anesthetic induction for appendectomy could allow to identify full     stomach patients who actually justify rapid sequence induction of anesthesia with exposure     to fast-acting neuromuscular blocking agents that implies.      Primary endpoint is to determine te percentage of patients who have a gastric content before     appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and     anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with     gastric content with the antral grading system (Perlas method) and to evaluate the     concordance between this methode and the cross-section antral area.   "
23118|NCT02983019|"     This study evaluates the statistics of influenza and acute respiratory viral infections     (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology:     disease severity and bacterial exacerbations; patients demography; treatment duration and     timelines; safety; quality of treatment) in routine clinical practice with focus on drug     therapy and usage of interferons' inducers.   "
23107|NCT02983162|"     Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a     significant association between the weighted genetic risk score and Dupuytren disease     recurrence. However, a significant dose-response relation was not found. This might be caused     by underestimating the recurrence rate, due to the retrospective nature of determining     recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to     see whether they suffered from recurrent disease.      Objective: We aim to determine whether the wGRS is associated with recurrent DD.      Study design: An observational study, in which the participants of the GODDAF study are     followed up.      Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were     previously included in another study on the genetic basis of Dupuytren disease.      Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is     the presence of recurrent Dupuytren disease.   "
23108|NCT02983149|"     Patients undergoing thoracic surgery require selective ventilation of one lung, which allows     surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung     ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the     placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of which are     in routine clinical use at University Health Network.      Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design     and two balloons, one of which is designed to fall into each of the right and left sides, it     may require less repositioning. Initial clinical experience with the EZ Blocker suggests that     it may be less likely than other blockers to become malpositioned during surgery.      This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker     at this institution, and to double-lumen tubes, the most commonly used devices to provide     lung isolation, with respect to intra-operative malpositioning and the speed of lung     separation and efficacy of lung collapse during thoracic surgery.      Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or     left-sided DLT, immediately prior to induction of anesthesia.      The primary end points of time to lung isolation and number of required repositioning     maneuvers.   "
23109|NCT02983136|"     The aim of this integrated Knowledge Translation (iKT) study is to develop and test a     multifaceted implementation intervention for feasibility, acceptability and effectiveness.     The intervention will be tailored to fit the context of the operating room (OR), to promote     OR team members' use of aseptic techniques during the care of frail persons undergoing acute     fracture surgery of the hip.      Through the use of an iKT approach, the investigators hypothesise that building on leadership     support, partnership between researchers, managers/clinical leaders and healthcare     professionals, a solid foundation for the sustained implementation of patient safety     innovations can be created.   "
23110|NCT02983123|"     This study evaluates if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac     troponin T (hs-cTnT) is safe and effective in patients with a lower pretest probability of an     acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1- and     4/6-hours, where absolute changes in the values will decide whether the patient need     hospitalization or not. Can the time interval to the second troponin test be reduced by using     an 1-hour high-sensitivity assay?   "
23111|NCT02983110|"     The purpose of this research study is to better understand how sex hormone therapy that is     used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy     for transgender women, affects a class of medications called NRTIs (nucleoside reverse     transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used     NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also     included in the combination products Atripla, Complera, and Stribild. The medication's     ability to work effectively may be altered when someone is also taking sex hormone therapy.      In order to determine this effect, samples will be collected from some parts of the body     where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV     virus and sex hormones that are present. The samples that will be looked at in this study     include blood, cells from the vagina, semen, and tissue biopsies from the female genital     tract and rectum.   "
23112|NCT02983097|"     The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide,     an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP.     R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of     Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy,     either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.   "
23113|NCT02983084|"     The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi     archwires and a recently marketed multiforce version of the same material for the initial     alignment and leveling of dental arches, as well as the expression of EARR in adult     orthodontic patients.   "
23117|NCT02983032|"     Background: between 50-74% of dementia carers report some sleep disturbance. However,     relatively few studies have looked at psychological treatment for insomnia in this group.     Dementia carers may be particularly at risk for suffering negative consequences from the     impact of sleep loss on top of the stress of their carer role. Researchers have found that     Brief Behavioural Treatment for Insomnia (BBTI) can be effective for improving symptoms of     insomnia in older adults. BBTI focusses on sleep-related behaviour such as napping and when a     person gets up and goes to bed.      Aims: this study aims to explore whether delivering group-based, Brief Behavioural Treatment     for Insomnia (BBTI) to family carers of people with dementia is feasible, given that, to     date, this has not yet been explored.      Who is eligible?: carers with insomnia who care for a family member with dementia and live     with them at home are eligible for inclusion in this study.      What is involved for participants?: taking part will involve an initial telephone discussion     with a researcher to check suitability. Participants will then meet the researcher for     assessment. Assessment includes a sleep interview and completing some questionnaires.     Participants will then be required to attend 3 group sessions of BBTI across the space of 4     weeks. After attending the BBTI group, participants will be asked to fill in some of the same     questionnaires that they filled in during assessment and again 4 weeks later. Participants     will also be invited to take part in a focus group to give feedback about the treatment and     their overall experience of being in the study.   "
23120|NCT02982993|"     This study provides Hepatitis C virus screening to the members of the World Trade Center     Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965,     and linkage to care for those found infected. The study will also determine if exposure to     human remains, blood and/or bodily fluids during the World Trade Center Health Program     activities are associated with Hepatitis C virus infection. These findings would be relevant     to the larger United States population, especially to persons born during 1945-1965 who are     at high risk of Hepatitis C virus infection.   "
23121|NCT02982980|"     The presence of pain, reduced range of motion and decrease of muscle strength of the upper     limb in the early postoperative period are some of the major deficiencies of the breast     cancer patients.      The objectives of this study were to evaluate muscle strength, range of motion (ROM), pain,     perimetry of the upper limbs and applied questionnaires of the upper lim function and quality     of life, in patients after surgical treatment of breast cancer in different postoperative     periods and different groups following rehabilitation: traditional postoperatively exercise     to perform at home versus traditional exercises associated with weekly physiotherapy sessions     to strength training for shoulder movements.   "
23122|NCT02982967|"     The purpose of present study was to investigate the effect of 10 weeks of recreational     physical activity program on the irisin levels, progenitor endothelial cells and     cardiometabolic profile in healthy children. Also, we investigated the correlation between     this markers with anthropometric data, body composition, cardiac autonomic balance and     physical fitness parameters. We evaluated eighty children aged 6 to 14 participated in the     recreational physical activity program by 10 weeks (Duration: 60 minutes; Intensity: 65%-85%     heart rate reserve; Frequency: 4 sessions/week). All parameters were evaluated before and     after this approach.   "
23123|NCT02982954|"     To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with     previously untreated advanced or metastatic Renal Cell Cancer.   "
23124|NCT02982941|"     This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to     characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor     activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses     (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or     refractory malignant solid tumors.   "
23125|NCT02982928|"     The current study is designed to measure and evaluate the pharmacokinetic profiling of     acetaminophen in the young obese patient population.   "
23126|NCT02982915|"     This is a phase I/II, randomized, blinded and placebo-controlled study to test the safety and     efficacy of LMCSs for improving vaccine immune response.   "
23127|NCT02982902|"     The purpose of this study is to determine if a specific type of cell-based immunotherapy,     using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to     treat infections by CMV.      Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the     blood of a donor and selecting the T-cells that can respond against a specific infectious     entity. These selected T-cells are then infused to the patient, to try to give the immune     system the ability to fight the infection. Adoptive T-cell therapy is experimental because it     is not approved by the Food and Drug Administration (FDA).   "
23128|NCT02982889|"     This study is designed to assess and characterize the safety and tolerability profile of     LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride     when infiltrated into a defined area of the medial calf, and to characterize bupivacaine     plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A     or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK     parameters of each product.   "
23129|NCT02982876|"     Airway stents are used as standard of care to identify which patients with excessive dynamic     airway collapse will benefit from a definitive surgical treatment. However, the specific way     in which these stents are effective has not been tested. The purpose of this research study     is to determine the effectiveness of airway stents when used in the airways of patients with     severe symptomatic excessive dynamic airway collapse compared to patients with severe     symptomatic excessive dynamic airway collapse that do not receive airway stent.   "
23130|NCT02982863|"     1. To understand the treatment patterns of OACs and baseline patient characteristics of          Japanese Non-Valvular Atrial Fibrillation (NVAF) patients        2. To determine whether warfarin and dabigatran new user group can be balanced using          propensity score matching using pre-specified baseline covariates.        3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in          database   "
23131|NCT02982850|"     The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population     and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of     all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of     ischemic stroke per year. Patients with valvular AF are known to have a higher incidence of     stroke than patients with nonvalvular AF. However, the relevant data are insufficient as     large randomized studies comparing NOAC treatment with warfarin, a conventional treatment,     did not include many patients with moderate and severe valvular AF.      Ischemic stroke is divided into symptomatic stroke with brain lesions on brain magnetic     resonance imaging (MRI) and silent cerebral infarct with lesions on brain MRI but without     stroke symptoms. According to a brain MRI follow-up study, the incidence of silent cerebral     infarct was 17.7% (254 subjects) over a period of 5 years, with 11.4% of 254 subjects     reporting to have experienced symptoms. This means that the incidence of silent cerebral     infarct is approximately 9 times that of symptomatic stroke. In addition, patients with a     history of silent cerebral infarct are known to be approximately twice more likely to     experience stroke in the future than those without a history of silent. Brain microbleed is     easily detected by brain MRI and is a well-known independent predictor of intraparenchymal     hemorrhage and silent cerebral infarct. The prevention of stroke by the study drug can be     indirectly assessed based on the incidence of silent cerebral infarct and brain microbleed on     brain MRI. Investigators tried to compare effect of dabigatran with conventional treatment in     terms of prevention of stroke by comparing incidences of silent cerebral infarct and brain     microbleed and symptomatic stroke using brain MRI.   "
25579|NCT02950870|"     The purpose of this study is to determinate the AMH levels before and after antiviral therapy     with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched     HCV-positive women not undergoing antiviral treatment.   "
23132|NCT02982837|"     To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who have     achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) <200 for     last 3-6 month) with NA's can result in increased rate of HBV infection eradication (HbsAg is     undetectable by serological blood testing with or without seroconversion to HBs antibody).   "
23133|NCT02982824|"     Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug     resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams     University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs     AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at     base line and after 6 months of treatment.   "
23134|NCT02982811|"     The purpose of this study is to determine whether additional therapy with i-ACT system is     effective in the training of functional skills in persons with central neurological diseases     (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).   "
23135|NCT02982798|"     A randomized, open-label, single dose, crossover study to compare the pharmacokinetic     characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in     healthy male volunteers   "
23136|NCT02982785|"     The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards     can predict the future course (post hospitalisation) of recovery of patients undergoing KA.     The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor     prognosis; 10=best prognosis).      To identify candidate prognostic factors, the therapist are asked to qualify their prognosis     narratively, by listing at least 3-5 factors that they consider important for their projected     prognosis score. There will be no maximum number of factors the physiotherapist can list.   "
23137|NCT02982772|"     The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and     Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these     excessive levels will enhance the efficacy of the intervention. To test researchers proposed     model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a     double-blind randomized clinical trial intent-to-treat design, comparing a standard     well-validated brief smoking intervention, that following national guidelines + nicotine     replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized     doses of nicotine replacement therapy). The primary outcome for this study will be rates of     smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified     continuous abstinence 3-, 6-, and 12-months post scheduled quit day.   "
23138|NCT02982759|"     Obesity among Hispanic children in the Lower Yakima Valley of Washington State is alarmingly     high. This study proposes to implement a comprehensive, multi-level intervention among     children, families, the schools, and the community to combat this problem. The two year     intervention will be measured by examining changes in children's body mass index.   "
23139|NCT02982746|"     At all of the follow-ups, including the worst period (between four and ten weeks), the     intervention group reported higher scores than the control group, suggesting in this RCT that     adopting the person-centred-care concept was a promising way to improve function and     wellbeing in patients with HNC.   "
23140|NCT02982733|"     In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug.     Recently, ABS has been shown to produce local hemostasis by implementing topically after     major arterial vessel injury. Reducing the compression time during patent hemostasis by     facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a     three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in     adjunct to short-time compression, compared to either short-time compression with     conventional sterile gauzes or with a TR band after transradial diagnostic procedures.   "
23141|NCT02982720|"     This is an open-label, single-arm, multicenter Phase II safety and efficacy study of     combination therapy with pembrolizumab and Sylatron (Peginterferon alpha-2b) in patients with     advanced cholangiocarcinoma who have progressed on or cannot tolerate frontline chemotherapy.   "
23142|NCT02982707|"     A single oral dose of BMS-986177administered to subjects of mild hepatic impairment, moderate     hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and     tolerability in these subjects   "
23144|NCT02982681|"     Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be     effective in promoting reduction in probing depth, gain in clinical attachment, and defect     fill in intrabony periodontal defects. The individual role played by bioactive glass putty in     combination with PRF is yet to be elucidated.      AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and     Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony defects     in humans.      Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and     Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on     other side. The primary outcomes of the study included changes in probing depth, attachment     level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3,     6, and 9 months. Radiographic assessment was done using standardized intra oral periapical     radiographs. Comparisions were made within each group between baseline, 3 months, 6 months     and 9 months using the ANOVA test followed by Bonferroni test.   "
23145|NCT02982668|"     The purpose of this academic lead study is to explore the ideal nutritional support strategy     for patient with acute severe stroke.   "
23146|NCT02982655|"     The purpose of this academic lead study is to explore ideal blood pressure targets and     optimum individualized anti-hypertension strategies in acute severe stroke.   "
23157|NCT02982512|"     The implantation of a deep brain stimulator (DBS) is an established option to improve the     symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical     therapy. Most centers perform this surgery using a technique that involves microelectrode     recording (MER) of neuronal activity for localization of the target nucleus, microstimulation     of identified targets, and neurological intraoperative testing in a cooperative patient.      Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at     subcortical areas of the brain without involving GABA receptors. It provides excellent     sedation without respiratory depression; also, it has an analgesic component and a     predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER.     The possible effect of dexmedetomidine in the PD symptoms is still unclear.   "
23147|NCT02982642|"     This study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled, parallel     trial which will be carried out in 15 centers around China. The study population includes     amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in both     gender. Participants will be randomly allocated to 1612 capsules (1.14g per time, 3 times per     day) or placebo for a 52-weeks double-blind treatment period. The primary outcome measure is     change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale     (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from     baseline in the Mini-Mental State Examination (MMSE), Delayed Story Recall test (DSR),     Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI     patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse     reaction during the entire treatment period. Statistical analysis will be conducted according     to per-protocol population and intend-to-treat population and the safety will be analyzed in     safety set.   "
23148|NCT02982629|"     1. To design and develop a prospective, randomized pilot study utilizing information from          electronic medical records to address follow-up adherence and reduce the gap between          recommended and actual follow-up adherence in patients with glaucoma.        2. To evaluate the impact of a telephone-based intervention on follow-up adherence in          patients with glaucoma using a randomly assigned comparison with usual care.   "
23149|NCT02982616|"     The purpose of this study is to test whether intragastrically infused fatty acid will     interact with positive emotion induction and if this effect is mediated by gut hormones.   "
23150|NCT02982603|"     This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel     controlled phase VI trial being carried out in 20 centers around China. The study population     includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in     both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2     times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton)     (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo     identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a     52-weeks double-blind treatment period. The primary outcome measure is change from baseline     in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of     conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental     State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative     Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is     being assessed by observing side effects and adverse reaction during the entire treatment     period. Statistical analysis will be conducted according to per-protocol population and     intend-to-treat population and the safety will be analyzed in safety set.   "
23151|NCT02982590|"     The purpose of this study is to compare the novel oral anticoagulant apixaban with the     standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus     over 6 months.   "
23152|NCT02982577|"     The purpose of this study is to evaluate the effectiveness of a spray the basis of     pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary     Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto     (HCFMRP-USP), and its impact on quality of life.   "
23153|NCT02982564|"     The purpose of this study is to evaluate the effect of two exercise programs: 1) one program     will be at low intensity; 2) the other program will be at moderate intensity. One hundred     forty two women who are breast cancer survivors will be recruited. Participants will be     educated on a home exercise program to be performed at either low or moderate intensity,     according to group assignment. Evaluations to participants will consist of function and     quality of life.   "
23154|NCT02982551|"     This study evaluates the effects of changing insulin levels on brain activity. Participants     will complete functional magnetic resonance imaging (fMRI) scans during fasting conditions,     then during an insulin infusion.   "
23155|NCT02982538|"     This randomized study examines how prolonged exposure (PE) therapy, an evidence-based     treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and     implemented in the Army. The study compares two PE training models: Standard PE training,     comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop     plus expert case consultation. In addition, patients with posttraumatic stress symptoms     receiving psychotherapy from participating providers will be invited to participate. After     completing PE training, use of PE components with patients reporting PTS symptoms and     clinical outcomes of these participating patients will be monitored for up to 18 months.   "
23224|NCT02981628|"     This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients     with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to     treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic     substance and may help find cancer cells that express CD22 and kill them without harming     normal cells.   "
23156|NCT02982525|"     A significant proportion of the United Kingdom population have inadequate levels of vitamin D     in their blood. Vitamin D is a fat-soluble vitamin that is essential for the growth and     maintenance of healthy bones through increasing dietary calcium absorption within the body. A     low vitamin D status has also been associated with other diseases such as osteoporosis,     cancer (especially colorectal cancer), cardiovascular disease and type 1 diabetes. Our skin     is able to synthesise vitamin D upon exposure to sunlight in summer. If exposure to sunlight     is limited, then a dietary supply of vitamin D becomes essential.      However, very few foods contain vitamin D. Among the best dietary sources of vitamin D are     oily fish (including salmon, mackerel, herring and trout) and fish oils. Recently, the     investigators found that certain shellfish, especially mussels, contain significant amounts     of a metabolite of vitamin D, 25(OH)D3. Consumption of this metabolite, as a supplement, has     already been shown to improve vitamin D status in humans. Whether consumption of mussels     improves vitamin D status is unknown.      In this study the investigators will be looking at whether consumption of 1, 2 or 3 portions     of mussels per week for 12 weeks increases vitamin D status in healthy people.   "
23332|NCT02980224|"     This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the     treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be     compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will     be evaluated for their signs and symptoms of dry eye disease and for safety throughout the     study.   "
23158|NCT02982499|"     The participant is being asked to be a subject in this research study because the participant     may have a disorder that can cause optic nerve damage and impairment of his/her visual     function which is called optic neuropathies (ON). Optic neuropathy refers to damage to the     optic nerve (a cable connecting the eyes and the brain to transmit the visual signals) due     to any cause.In this study, the investigator is using magnetic resonance imaging (MRI) and     ophthalmic measures such as optic coherent tomography(OCT), which are non-invasive imaging     tests to measure the changes in eye globe shape ,the flow of blood and brain fluid. It is     hoped that this study will provide new knowledge that may allow the investigator to better     understand the cause of symptoms associated with optic neuropathy and ways to better monitor     what is happening.   "
23159|NCT02982486|"     The purpose of this study is to determine whether nivolumab plus ipilimumab are effective and     safe in the treatment of sarcoma and endometrial carcinoma patients with somatic deficient     MMR as a selection tool.   "
23160|NCT02982473|"     The Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics     and Interventions (RACE-IT) represents a mono-centric registry of patients being     hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation)     and sudden cardiac death (SCD).      Detailed findings of patients' clinical outcome regarding mortality and co-morbidities     related to the presence of invasive diagnostics or therapies including coronary angiography,     percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter     ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be     documented. Patients will be included when being hospitalized from the year 2004 until today.   "
23161|NCT02982460|"     Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder     pain with prevalence estimated to be as high as 14% in general working-age population. RCT is     a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome,     RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is characterised     by persistent pain and/or disability and/or recurrent episodes. It often leads to decrease     function, lower health-related quality of life, poor sleep quality, work absenteeism, as well     as patient's suffering. Previous studies support exercise as an adequate treatment in RCT.     Nevertheless, our knowledge, there is no studies evaluating the effects of isoinertial     training in RCT. Therefore, the aim of this study will be to pilot the methods proposed to     conduct a substantive study to evaluate the efficacy of isoinertial training plus eccentric     training versus eccentric training alone on improving pain and function in RCT. The     objectives were to evaluate: (i) The process of recruitment and retention rates; (ii)     Willingness of participants to be randomised; (iii) The extent of contamination between     groups; (iv) Participant adherence with treatment. The secondary aim will be to analyse the     effects of isoinertial training plus eccentric training versus eccentric training alone on     rotator cuff strength, scapular muscle activity, and scapular muscle endurance in people with     RCT.   "
23162|NCT02982447|"     It is a randomized controlled trial with tandem colonoscopy.Participants were randomized for     use of either blue laser imaging or conventional White Light Colonoscopy on withdrawal     method.comparison of detection and miss rates of BLI group Versus conventional White Light     Colonoscopy.   "
23163|NCT02982434|"     The aim of this prospective randomized double-blind study was to compare the efficacy of new     pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for     preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial     fibrillation undergoing coronary artery bypass grafting.   "
23164|NCT02982421|"     Art Therapy is a health profession in which art making is utilized as a means of expression     and communication within a therapeutic and supportive relationship [1]. Art therapy has been     shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms     which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide     an initial understanding of the mechanisms through which art therapy facilitates symptom     reduction [8]. Breast cancer patients have reported that art therapy provided them with     access to emotional material otherwise inaccessible [9]. The goal of this study is to examine     the effect of art making within a therapeutic framework on emotional awareness and     acceptance.   "
23256|NCT02981212|"     The purpose of this clinical study is to evaluate the efficacy and safety of that test group     was administered with Mycophenolate Mofetil in combination with corticosteroid in patients     with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without     administration of Mycophenolate Mofetil.   "
23165|NCT02982408|"     Low birth weight (LBW), a marker of impaired fetal growth is an independent and strong risk     factor for type 2 diabetes (T2D). A western lifestyle characterized by a surplus of calories,     and/or a low physical activity level, associated with increased fat storage and altered lipid     metabolism plays a central role in the pathogenesis of insulin resistance and T2D. Using     state-of-the-art large-scale integrative physiology studies combined with basic studies of     adipose and muscle tissue stem cell functions, the investigators aim to determine if LBW     individuals exhibit decreased subcutaneous adipose tissue expandability, postprandial     hyperlipidaemia and ectopic fat accumulation when exposed to 4 weeks of carbohydrate     overfeeding. The investigators will subsequently examine if exercise training can revert     and/or minimize the deleterious effects of carbohydrate overfeeding in a possibly birth     weight differential manner.   "
23166|NCT02982395|"     The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of     patients with recurrent Ta and T1 who experienced treatment failure with at least one prior     BCG intravesical treatment.   "
23167|NCT02982382|"     The burden of low back pain more than doubled in the last 20 years, probably caused by     biopsychosocial factors. Some noninvasive treatments have been applied in individuals with     chronic nonspecific low back pain as spinal manipulation and pain education. However, it is     not already clear the neurophysiological effects of these treatments.The purpose of this     research is to verify the effects of the technique of spinal manipulation and pain education     in individuals with chronic low back pain   "
23168|NCT02982369|"     This study aims to investigate the effects of vertebral manipulation and pain education on     subjects with neck pain. For this purpose, 128 subjects who present chronic neck pain will be     selected and allocated randomly into 2 groups: the vertebral manipulation group and the pain     education group.   "
23169|NCT02982356|"     The risk of abnormal chromosome and structure is much higher in twins than in singletons, and     traditional early pregnancy screening strategy for single pregnancy is not suitable for     twins. Based on our management experience of fetal medicine at twin pregnancy, and     multi-center cooperation, the study will carry out the following clinical studies:        1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for          twin pregnancy.        2. fetal chromosomal abnormalities   "
23170|NCT02982343|"     Charcot Marie Tooth (CMT) is the most common inherited neuropathy. It affects the nerves of     the hands and feet first, slowly progressing towards the centre of the body. It causes     varying degrees of weakness and reduced feeling, usually affecting the feet and ankles first.     High incidence of falls and knock on effects in quality of life are common. This is a     lifelong condition which, though not life limiting, does not have a cure. Research into the     effect of balance rehabilitation in people with CMT has been limited to traditional     exercises, which do not address the complex nature of balance impairments in this condition.     Multi-sensory rehabilitation has proved beneficial in improving balance in people with     sensory neuropathy. Research shows that strengthening trunk muscles can improve balance in     older people. Trunk and muscles close to it are largely unaffected in people with CMT,     therefore these muscles could be strengthened in these patients. This study proposes to     assess the feasibility of multi-sensory balance training, strength training with a focus on     the trunk and muscles close to the trunk, and falls management education. This comprehensive     approach is reflective of a clinical physiotherapy programme. Though a life-long condition,     many people with CMT lead full lives. A home based programme is proposed to so that patients     can fit it into their lives without having to travel for treatment. Therapists will use     self-management principles within treatment. Measurements will be taken prior to and     following treatment including physical measures, questionnaires and interviews. The     physiotherapy interventions will be taught home and data collection will be at the National     Hospital for Neurology and Neurosurgery, University College London Hospitals (UCLH).   "
23171|NCT02982330|"     Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to     sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is     known to reduce post-meal glucose excursions but it is unknown whether lowering the     carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout     the day. The aim of this study is to examine, under free living conditions and using typical     dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal     glycemia when compared to consuming a low-fat breakfast (per the current diabetes     guidelines).   "
23172|NCT02982317|"     A novel automated ultrasound software system has been developed which identifies for the     practitioner the intervertebral spaces in the lumbar area. This study aims to investigate     whether this new technology has a greater accuracy of identifying intervertebral spaces that     manual palpation.   "
23173|NCT02982304|"     Dystonia is increasingly being considered as a multi-nodal network disorder involving both     basal ganglia and cerebellar dysfunction. The aim of this study is to determine if     Multi-Target Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients     who are receiving inadequate therapy from GPi DBS.   "
23174|NCT02982291|"     Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly     population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain,     as well as by weakness precipitated by walking and prolonged standing. Self-management     options include physical therapy, which includes exercise as a core component for improving     the flexibility and mobility of the spine and hips. A Williams flexion protocol has     historically been used to treat low-back pain following degenerative changes to the posterior     elements of the lumbar spine. However, few studies have been done to validate the efficacy of     this protocol. A more focused treatment protocol may be more efficacious. Patients in this     study will be randomized to receive either the generic physical therapy protocol (15     sessions) or the focused rehabilitation program (5 sessions). The sessions will take place     over the course of 6 months. Outcomes will be assessed using validated questionnaires and     physical function tests.   "
23225|NCT02981615|"     Infections are a major and prevalent life-threatening complication among patients with     myelodysplastic syndrome (MDS). Currently, the role of prophylactic antibacterial agents     after chemotherapy in MDS patients remains controversial and there are no clinical guidelines     for infection prophylaxis in this clinical setting. We will conduct a prospective study to     evaluate the potential benefit of prophylactic antibacterial (Levofloxacin) on the rate of     febrile episodes/infections in Azacytidine treated MDS patients.   "
23175|NCT02982278|"     This research project will evaluate the relationship between cardiovascular risk factors,     degrees of physical and mental activity prior to the stroke, brain tissue integrity,     post-stroke community participation and neurological recovery after the stroke. Investigators     will recruit and study healthy and post stroke participants, gaining insight into the     possible mechanisms that explain why the adverse risk profile, which is more commonly present     in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less     favorable recovery post stroke.   "
23176|NCT02982265|"     Pre-eclampsia is a heterogeneous multisystem disorder that complicates 2-8% of pregnancies     and remains a leading cause of maternal and perinatal mortality and morbidity.      Pre-eclampsia is defined as new onset of hypertension (defined as a diastolic blood pressure     ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings     taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and     substantial proteinuria (defined as excretion of protein ≥300 mg in 24 h or a protein     concentration ≥ 300 mg/L or ≥ 1 + on dipstick in at least two random urine samples taken at     least 4-6 h apart but no more than 7 days apart) at or after 20 weeks of gestation.      Pre-eclampsia only occurs in the presence of placenta and is resolved by delivery of the     same. However, the underlying causes of the disease remain largely unknown.   "
23215|NCT02981745|"     This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B     cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's     macroglobulinemia (WM).      The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and     tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin     lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).   "
23177|NCT02982252|"     Losing the ability to walk can lead to fewer opportunities to socialize with friends and     family and participate in the community. When this happens, powered wheelchairs can provide     access to homes and communities, contributing to health and well-being. Training by a     qualified occupational therapist allows an individual to use a powered wheelchair safely and     effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time     consuming for people with cognitive and physical challenges. In this study, the investigators     will ask participants with cognitive impairments to complete training with an occupational     therapist using either a shared control wheelchair or training methods according to the     standard of care. The investigators believe shared control training, entitled Collaborative     Powered mobility Innovative Learning OpporTunity (CoPILOT) will enhance driving skill while     maximizing safety learning. CoPILOT has the potential to enable people to participate more in     their day to day lives and regain mobility independence.   "
23178|NCT02982239|"     Evidence suggests that student athletes frequently experience sleep problems and are aware of     the impact of sleep loss on mental and physical outcomes. As such, student athletes are     motivated to improve sleep quality in order to improve their outcomes for overall athletic     performance. This study will consist of two parts. The first part will be a survey. Fall     athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a     survey within the first week of their arrival on campus. The survey will assess multiple     domains of student-athlete health, namely, sleep duration and quality, mood and depression,     stress, and mental and physical well-being. The responses to the survey will be confidential,     and students will be compensated for the survey. At the end of the semester, students will be     invited to complete the survey again.      Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the     intervention, based on predetermined criteria. The intervention will include an information     session where students may ask questions. Students will be sent text message reminders about     adherence to the program and will be asked to monitor their sleep quality with sleep diaries.     The intervention will consist of the half of the 40 chosen students, (20 students), who will     be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit     bit. Please note that all of these items are commercially available and are not meant to be     used to treat or prevent human illness nor injury and do not require FDA oversight. The     blue-blocking glasses will ensure that blue light from electronic devices will not interfere     with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright     LED light will provide bright blue light in the morning to help students wake and an amber     light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as     well as adherence to the program.   "
23179|NCT02982226|"     The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™     injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared     to a Corticosteroid Injection which is considered standard of care.   "
23180|NCT02982213|"     The purpose of the study is to evaluate if maternal anxiety is improved when a parturient     gets her choice with regard to the presence of a companion during epidural catheter placement     for labor analgesia. It will be focused on parturients having their first child with the     current partner. Additionally, it will investigate the effect of ethnicity, health literacy     (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as evaluated by the     Pain Catastrophizing Scale), and the relationship of the support person to the parturient.     The investigators hypothesize that there may be specific subgroups in which maternal anxiety     is improved when a parturient gets her choice regarding the presence of a companion during     labor epidural catheter placement; however, a significant improvement in maternal anxiety,     when including all participants, will not be appreciated.   "
23181|NCT02982200|"     A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study     conducted to assess the performance of the Medina Embolization Device when used in unruptured     and ruptured intracranial aneurysms.   "
23182|NCT02982187|"     This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2     complete block design in subjects with chronic obstructive pulmonary disease (COPD) to assess     the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler (DPI)     (closed triple therapy) versus delivering triple therapy using two different types of DPI     (open triple therapy). The primary objective of the study is to evaluate the proportion of     COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using     combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all     subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with     either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the treatment     sequences. At the end Visit 1, subjects will complete the inhaler preference questionnaire     (PQ). There is no active treatment and subjects will continue to take their own prescribed     COPD medication for the duration of the study. ELLIPTA and DISKUS are registered trademarks     of the GSK group of companies; TURBUHALER is a registered trademark of AstraZeneca and     HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.   "
23183|NCT02982174|"     Compare the signal to noise ratio of each device at various retinal layers.   "
23184|NCT02982161|"     The MR308-3501 study is a multicenter, randomised, double-blind, parallel-group study in male     and female adult subjects to demonstrate the efficacy of MR308 in the treatment of acute     moderate to severe pain after the extraction of at least two third molars requiring bone     removal.   "
23185|NCT02982148|"     This study is designed to compare the effectiveness of intradermal injection and subcutaneous     injection with methylene blue for early-stage breast cancer patients who need sentinel lymph     node biopsy.   "
23188|NCT02982109|"     The investigators have recently reported a relationship between pain induced by peripheral     venous cannulation and postoperative pain. The purpose of this study is to validate this     method of postoperative pain prediction in a larger cohort subjected to different types of     surgery.   "
23189|NCT02982096|"     The purpose of this study is to determine if healing occurs within 21 days of treatment with     the use of the CellutomeTM device for fractional epidermal micro grafting compared with     standard acellular techniques (creams and membrane dressings).      Healing will be determined by time to ≥90% epithelialization within 21 days of treatment.     Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale     (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to     standard techniques without application of skin cells (epidermal grafts = acellular) and will     be measured twelve months post treatment application, ± 6 months.   "
23232|NCT02981524|"     This study will be looking at the objective response rate (ORR) as measured by RECIST in in     patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated     with CY/GVAX in combination with Pembrolizumab.   "
25580|NCT02950857|"     An open-label study in which 6 patients will receive once-weekly subcutaneous injections of     EPEG for 4 weeks. Final visit will occur 60 days after study entry   "
23190|NCT02982083|"     The investigators select 40 postmenopausal women suffering from RA with 2.5<DAS28<5.5     referring to rheumatology clinics of Mashhad university of medical sciences and randomly     divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are     administered double blind. In the beginning, total bone mineral density (BMD) assessment is     carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3     months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are     allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist     monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At     the end of month 3, disease activity and probable complications are evaluated and compared in     2 groups. Classic regimen should be started for every patient who doesn't enter remission     phase in first 3 months.      In 4th month, DMARD regimen is administered and then patients are visited every 2 months.     Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another     total BMD test is carried out and then data are analyzed including changes in BMD, DAS28,     EULAR response criteria and HAQ-DI score.   "
23191|NCT02982070|"     The aims of this study are to (1) assess the extent of psychological distress for incoming     first-year students at the University of Tulsa (Part 1), (2) assess the impact of mental     toughness training on the trajectory of psychological well-being and academic success (Part     2), (3) assess the impact of mental toughness training on neural and behavioral reactivity to     affective stimuli and decisions (Part 3), and (4) examine genetic markers of resiliency in     college populations and interactions between genetic markers and response to mental toughness     training (Part 2).   "
23192|NCT02982057|"     The aim of the present study is to compare the evolution of non culprit lesions after     treatment by BVS versus optimal medical therapy at 2-years follow- up   "
23193|NCT02982044|"     The purpose of this study is to determine if different blood flow patterns change artery     function. We hypothesize that the temporary induction of an oscillatory blood flow pattern     will result in an immediate improvement in artery function. Participants will be asked to     come to the Vascular Dynamics Lab (IWC E102) at McMaster University for a total of 3 visits.     The first visit will allow the participant to get comfortable with the lab and the upcoming     tests; and the next 2 visits will be scheduled at the same time of day to collect data. For     visits 2 and 3, participants will be asked to arrive after a 4 hour fast. At these visits,     ultrasound imaging will be used to examine the arteries and how they may change when blood     flow patterns through an artery in the arm are changed. To change blood flow in the arm,     heat, rhythmic squeezing of the forearm with a cuff, or handgrip exercise will be used. These     interventions will be applied to the left forearm, from the elbow to the fingertips. A     trained technician will also draw a blood sample during both data collection visits. A total     of 10 participants will be recruited for the entire study.   "
23194|NCT02982031|"     The primary objective of this study was to compare ultrasound visibility of the lumbar plexus     at the intertransverse space between paramedian transverse scan and shamrock technique.     Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary     objective was to assess ultrasound visibility of each relevant structure and overall     visibility between these two methods.   "
23195|NCT02982005|"     The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in     subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to     receive KHK4827 or placebo for 12 weeks   "
23196|NCT02981992|"     In this observational study, the investigators evaluated the Treg number and function in a     population of patients undergoing hemodialysis (HD).      In particular, the investigators considered the relationship of Treg cell status with the     different HD modalities and clinical parameters.   "
23197|NCT02981979|"     The purpose of this study is to investigate the efficacy and Safety of Leflunomide in     Patients With Active Phase of Takayasu's Arteritis   "
23198|NCT02981966|"     Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in     endogenous glucose production (EGP) following the induction of glucosuria (when glucose is     excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.   "
23199|NCT02981953|"     The current management of tricuspid regurgitation (TR) is either conservative (by medication)     or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen     or appear late after successful mitral valve surgery which portends a poor prognosis     .However, standard surgical approaches requiring cardiopulmonary bypass and especially second     surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable     risk-benefit balance. Therefore there is a need for novel devices enabling interventional     cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter     methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using     transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the     approved indication for mitral annuloplasty. The Cardioband System is expected to allow for     treatment of patients that would otherwise not undergo Tricuspid valve repair due to the     invasiveness of current techniques.      The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for     treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September     2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty,     however deployed on the beating heart through a transvenous approach. The CE mark study with     30 subjects has been completed and documented significant reduction of severity of MR and     improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ),     Ney York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate     to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system     for repair the Tricuspid Regurgitation.   "
23200|NCT02981940|"     This research study is studying a targeted therapy as a possible treatment for recurrent     glioblastoma (GBM).      The following intervention will be used in this study:      -Abemaciclib   "
23201|NCT02981927|"     To evaluate the early metabolic responses (whole body and within muscle tissue) to a single     day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of     inactivity per se vs alterations in diet   "
23247|NCT02981329|"     The purpose of this study is to determine whether metformin is effective in the treatment for     sickle cell anemia (SCA) and non-transfusion dependent thalassemia (NTDT).   "
23202|NCT02981914|"     This pilot study has been designed to investigate the safety of pembrolizumab treatment for     disease relapse following allogeneic stem cell transplant (alloSCT). Pembrolizumab will be     administered at a fixed dose of 200 mg IV every 3 weeks. Approximately 12-26 patients with     relapsed MDS, AML, or mature B cell (B-NHL, cHL) malignancies that have relapsed following     alloSCT will be enrolled on this trial. Pembrolizumab treatment will be administered for up     to 24 months, provided that neither disease progression, nor development of a dose-limiting     toxicity (DLT), has occurred. Adverse events will be monitored every three weeks throughout     the trial and graded in severity according to the guidelines outlined in the NCI Common     Terminology Criteria for Adverse Events (CTCAE) version 4.0. This trial will be conducted in     accordance with Good Clinical Practices.   "
23203|NCT02981901|"     No structured organization for ovarian first line management emerges in France. Management     across France seems to depend on regional contexts.      Regions display no specific organization or delineate regional network for the ovarian cancer     management or report centralized management revolving around referent centers. These     different templates present a major problem in identifying differences, costs and benefit.      To deal with this issue the Investigators propose a health economic evaluation based on     cost-effectiveness analyses, completed with a budget impact analysis. This study will     investigate the cost-effective management of patients with initial ovarian cancer using     databases representative of different parts of French territories.   "
23204|NCT02981888|"     The purpose of this study is to find out the relationship between the bile acids, fatty acids     (fatty acids are part of the diet) and bacteria that are present in the intestines.   "
23205|NCT02981875|"     Children with reading eye movement problems were recruited for this study. The treatment     group was provided with oculomotor training for 8 weeks, the control group was given placebo     exercises.   "
23206|NCT02981862|"     The current project is based on the assumption that a diagnosis of human papillomavirus     associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical     Cancer, Vulvar Cancer, Anal Cancer or Oropharynx Cancer at any stage of the disease and     including surgical treatment for the small tumors.   "
23207|NCT02981849|"     The purpose of this study is to address the needs for efficient and informative measurement     for evaluating adolescent Screening, Brief Intervention, and Referral to Treatment (SBIRT)     strategies. The investigators will undertake a longitudinal cohort study to build and     validate a substance specific measurement battery that includes patient-centered and     intermediary outcomes which can be integrated into a range of healthcare and research     settings. The results of this project will enable evaluation of SBIRT trials and clinical     efforts by validating a parsimonious set of measurement tools that can be incorporated into     electronic health records. The primary goal of the proposed project is to develop a set of     brief, valid tools that will allow both researchers and clinicians to collect information     that enables evaluating and refining brief interventions.      The main objective is to define and disseminate a set of brief and easy to administer     measures that accurately detect 1) substance use frequency, 2) substance-specific patient     centered outcomes and 3) intermediate measures of impact of adolescent SBIRT. The specific     aim addressed in this project is to develop and administer an assessment battery that     includes novel questions assessing substance use to be validated against criterion standard     measures both cross-sectionally and longitudinally.   "
23208|NCT02981836|"     The purpose of this study is to evaluate the protective effect, safety and immunogenicity of     a live attenuated varicella vaccine in healthy children.   "
23209|NCT02981823|"     To provide information on reducing the incidence of periprosthetic fractures during hip     replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic     fractures and their effects on hip functional recovery.   "
23210|NCT02981810|"     To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation     can create changing in the tonsillar medium for recurrent tonsillar infections and stop the     recurrent infections?   "
23226|NCT02981602|"     To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive     patients with chronic hepatitis B virus infection   "
23227|NCT02981589|"     The main purpose of the present study was to explore the weaning failure rate from invasive     mechanical ventilation and to identify risk factors of weaning failure.   "
23211|NCT02981797|"     This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as     standard of care.      Participants will take part in this research study because they have chosen Radium 223     treatment for their prostate cancer that has spread to the bone and causing pain.     Investigators want to find out if a blood test performed before and after the Radium 223     treatment will help to understand how prostate cancer cells react to this therapy.      In this pilot study, researchers want to find out if Radium 223 given as part of standard     treatment for prostate cancer can decrease the number of circulating prostate cancer cells.     Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the     changes in the number of circulating prostate cancer cells before and after Radium 223,     researchers would also like to look at the changes in a DNA damage marker, called gamma H2AX,     in the circulating prostate cancer cells before and after treatment with Radium 223.     Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same     tube of blood that is used for assessing the changes in the number of circulating prostate     cancer cells.   "
23212|NCT02981784|"     Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+)     acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study     compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus     allogeneic stem cell transplantation (allo-SCT).   "
23213|NCT02981771|"     Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of     this study is to explore the effect of specific exercise program based on balance and     coordination on stability parameters   "
23214|NCT02981758|"     A comparison of reported estimated blood loss with quantified blood loss in all patients     whose medical records indicate Triton was used during their vaginal delivery.   "
23248|NCT02981316|"     The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the     treatment of recurrent CDI in subjects who have had at least one recurrence after a primary     episode (i.e., at least two episodes) and have completed at least two rounds of     standard-of-care oral antibiotic therapy.   "
23216|NCT02981732|"     For nearly 112 million patients with osteoporosis in China, it is of great significance for     preventing and treating by clearly understanding the molecular mechanism of kidney     deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is     an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for     kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of     the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe     impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system     using the technology of adenovirus associated virus. ②explore impacts of over-expression and     silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③     analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon     immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism     by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism,     so as to demonstrate if the hypothesis of this study that the molecular osteoimmunological     mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely     related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone     metabolism is right or not.   "
23217|NCT02981719|"     The aim of this study was to observe the survival status, recurrence and death time of     patients with pancreatic cancer treated by chemotherapy combined with IRE. The survival and     overall survival of the patients were evaluated respectively.   "
23218|NCT02981706|"     This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication     rates and functional status decline in subjects age 70 years and older referred for vascular     access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus     arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and     undergo measurements of functional status including gait speed, grip strength, and     self-reported function over 6 months. The primary hypothesis to be tested is that AVF     placement will result in a higher proportion of primary access failure as defined by a binary     composite primary endpoint of an unsalvageable access or an immature access or a     non-functional access measured at 6 months compared to AVG placement. In addition, the study     will evaluate whether AVF placement and a greater number of access procedures will result in     a greater decline in functional status as measured by the average change over 6 months in     gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm,     Shoulder and Hand Survey.   "
23219|NCT02981693|"     The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP     as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients     needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus     arm randomly. After root canal shaping and cleaning, the teeth were obturated according to     their arms. Assessment of postoperative pain was done 1 week after root canal obturation     using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were     carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the     arms.   "
23220|NCT02981680|"     Background:      Acute kidney injury (AKI) following coronary artery bypass graft (CABG) surgery is a major     complication occurring in 1% to 53% of patients (depending on how it is defined) with the     pooled rate of 18.2% and unfortunately 2.1% of them require renal replacement therapy.     Cardiopulmonary bypass (CPB)-associated AKI increases mortality 2-4 fold regardless of AKI     definition. It is also associated with increased risk of postoperative stroke, acute     myocardial infarction, cardiac tamponade, heart failure, and lengthened intensive care unit     and hospital stays. Even minor elevations of postoperative serum creatinine (SCr) have been     associated with a significant increase in 30-day mortality, from a 3-fold increase risk for a     small elevation of up to 0.5 mg/dL from baseline to an 18-fold increase risk of death with a     SCr rise greater than 0.5 mg/dL.      The pathogenesis of CPB-associated AKI is complicated and includes hemodynamic, inflammatory     and other mechanisms that interact at a cellular level. To date, despite several clinical     trials of pharmacologic interventions, none of them have demonstrated conclusively efficacy     in the prevention of AKI after cardiac surgery.      Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ     or tissue, provokes a protective effect that can reduce the mass of infarction caused by     vessel occlusion and reperfusion. In CABG surgery, cardiomyocyte injury caused by myocardial     protection failure is predominantly responsible for adverse outcomes. RIPC was shown to     reduce troponin release 24 h postoperatively in children undergoing corrective surgery for     congenital heart disease. Other studies demonstrated that RIPC using brief ischemia and     reperfusion of the upper limb reduces myocardial injury in adult patients undergoing CABG     surgery.      Due to the similarities between the mechanisms of ischemia-reperfusion injury produced by     RIPC and those proposed for AKI after CPB, we decided to test the hypothesis that RIPC     prevents AKI in patients undergoing CABG surgery.      Methods:      170 patients who fulfill all inclusion and exclusion criteria will be divided into case and     control groups (85 patients in the case and 85 patients in the control group).      Patients in the treatment group will receive three sequential sphygmomanometer cuff     inflations on their right upper arm after induction of anesthesia in the operating room. The     cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with     five minutes deflation in between inflations. Following this pre-conditioning phase, surgery     will be started. The entire pre-conditioning phase will last 30 minutes.      Patients in the control group will have the sphygmomanometer cuff placed on their right upper     arm, but the cuff will not be inflated. Similar to patients in the treatment group, patients     in the control group will undergo the same 30 minute delay before starting surgery.      Complete blood count (CBC), SCr, liver function test (LFT), prothrombin time (PT), partial     thromboplastin time (PTT) and urine analysis (U/A) will be checked before surgery.      After surgery, complete blood count (CBC) and SCr will be checked daily. If AKI occurs, it     will be managed and dialysis will be done if the patient requires it. All patients will     undergo electrocardiogram, LFT, electrolytes, prothrombin time (PT), and partial     thromboplastin time (PTT) after CABG surgery during hospital course   "
23221|NCT02981667|"     Previous research is equivocal concerning if high intensity interval training is viewed as     more aversive versus moderate exercise. Our data in active men and women showed that interval     training is viewed as more enjoyable than higher volume moderate exercise.   "
23222|NCT02981654|"     This is a prospective, open-label, multi-center, non-comparative study that will be conducted     on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence     (SUI).      Following the screening period, including urodynamic assessment to confirm SUI, each subject     will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one     year. The main efficacy endpoint in this study is defined as significant improvement (score     of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit.     Various subjective and objective measures of incontinence severity, quality of life, sexual     function and tissue effects will be performed at follow up.   "
23223|NCT02981641|"     The purpose of this study is to find the better radiation therapy between intraoperative     radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).   "
23228|NCT02981576|"     Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and     neurological deficits in injured individuals. The limited ability of the Central Nervous     System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery     of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated     accidents, falls, and violence-related injuries.      Unfortunately, there is still no effective clinical treatment for SCI. In recent years,     tissue engineering and regenerative medicine based approaches have been proposed as     alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed     promising results in several studies. Our aim is to assess and compare the safety and     effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.   "
23229|NCT02981563|"     The aim of this project is to test and evaluate a nursing intervention, Time Together (TT),     created to enable quality interactions between patients and staff in psychiatric inpatient     care. The research questions are:      Does TT influence the quality of interactions between staff and patients? Does TT influence     patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of     perceived stress and levels of stress of conscience? Does TT influence the prevalence of     coercive measures, mean length of hospital stay and the use of PRN medication?      In parallel, a process evaluation will be conducted, answering questions such as:      How do staff and patients describe their experiences of the intervention and how do     contextual factors influence the effects of the intervention? What are the relationship     between the outcome variables and the degree of compliance with the intended intervention?     What problems are there with recruitment and dropouts?   "
23230|NCT02981550|"     The purpose of this feasibility study is to test a device which analyzes breath and may allow     doctors and health professionals to immediately determine if an ill patient has a specific     type of bacterial infection. This will allow a health professional to provide immediate     targeted antibiotics to properly start treatment without delay.   "
23231|NCT02981537|"     The purpose of this study is to find a novel method for placing endobronchial blockers     without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic     surgery.   "
23233|NCT02981511|"     Optiflow can be used to prolong the apnoea period under anaesthesia without falls in blood     oxygen saturation. This study is designed to assess whether the Optiflow system can     efficiently replace conventional anaesthetic mask and circuit preoxygenation so that it could     be used in emergency anaesthesia. If so, it would be then be in place in the case of     difficult or failed intubation to maintain oxygenation ie: it could preoxygenate and then     maintain oxygenation seamlessly.   "
23234|NCT02981498|"     To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin,     5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular     carcinoma (HCC).   "
23235|NCT02981485|"     Breast cancer related lymphedema (BRCL) is a common complication following breast cancer     treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in     the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities,     impaired physical mobility, mental discomfort, reduced quality of life and erysipelas.     Therapy of BRCL is divided into conservative and operative methods. However, all the above     method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In     this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety     of this method will be also assessed.   "
23237|NCT02981459|"     The specific purpose of this study is to provide objective data in prospective open label     design (n=40) to support the use of Mirabegron as a treatment for pain related urinary     frequency and urgency. Women with bladder pain have a poor response to traditional     anticholinergic therapy for their symptoms of frequency and urgency.   "
23238|NCT02981446|"     The purpose of this study is to investigate the intraocular pressure-lowering effect and the     safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in     subjects with open angle glaucoma or ocular hypertension.   "
23239|NCT02981433|"     Vulvodynia is a syndrome of unexplained vulvar pain that is frequently accompanied by     physical disabilities, limitation of daily activities (such as sitting and walking), sexual     dysfunction and psychologic disability. Originally suggested by McKay, the term vulvodynia     has also been suggested by the International Society for the Study of Vulvar Disease Task     Force to describe any vulvar pain. The incidence and prevalence of vulvodynia have not been     well studied. Age distribution for the condition may range from the 20s to the 60s, and it is     limited almost exclusively to white women. Obstetric and gynecologic history is usually     unremarkable. Risk-taking sexual behavior is rare, and few patients have a history of     sexually transmitted diseases. Vulvar pain usually has an acute onset, at times associated     with episodes of vaginitis or certain therapeutic procedures of the vulva (cryotherapy or     laser therapy). In most cases, vulvodynia becomes a chronic problem lasting months to years.     Vulvar pain is frequently described as burning or stinging, or a feeling of rawness or     irritation.      Most patients consult several physicians before being diagnosed. Many are treated with     multiple topical or systemic medications, with minimal relief. In some cases, inappropriate     therapy may even make the symptoms worse. Since physical findings are few and cultures and     biopsies are frequently negative, patients may be told that the problem is primarily     psychologic, thus invalidating their pain and adding to their distress.   "
23253|NCT02981251|"     The purpose of the study is to evaluate the effect of health education on blood pressure     reduction compared to usual care among uncontrolled hypertensive patients of suburban     community of Surkhet district of Nepal.   "
23254|NCT02981238|"     The aim of the study is to evaluate the effect of a one-month supplementation with     Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac     so-called adjustment subjects (occasional or short-term insomnia)   "
23255|NCT02981225|"     The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms     in patients with mild to moderate major depression in a strategy with Phytostandard®     Rhodiola-Saffron supplementation   "
23240|NCT02981420|"     A youth's contact with the juvenile justice system represents an opportune moment for suicide     screening and brief suicide intervention for indicated youth. This study will provide data on     the novel implementation of an evidence-based brief suicide intervention, safety planning,     administered by front-line juvenile court staff for suicidal court-involved non-incarcerated     youth. Data will inform the dissemination and implementation of suicide brief interventions     to be delivered by front-line staff at the time of mental health screening in the juvenile     justice system. The proposed study is consistent with the NIMH Strategic Plan by testing an     intervention for effectiveness in community settings (Strategy 3.3) and establishing a     research-practice partnership to improve D&I of evidence-based MH services (4.2). The unique     service delivery by JJ court staff also supports the NIMH goals to develop innovative service     delivery models (Strategy 4.3) as well as validate a MH intervention for an underserved     population (Strategy 4.1). This proposal also addresses the Healthy People 2020 goals of     reducing suicide attempts (MHMD-2).   "
23241|NCT02981407|"     The purpose of this study is to compare two red blood cell transfusion strategies (liberal     and restrictive) for patients who have had an acute myocardial infarction and are anemic.   "
23242|NCT02981394|"     The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including     osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse.     The purpose of this study is collect a longitudinal case series of patient reported outcomes     following BMAC injections for musculoskeletal conditions including osteoarthritis,     tendinopathy and injuries to ligaments, tendons and muscles.   "
23244|NCT02981368|"     This study evaluates the safety and diagnostic performance characteristics of 18F-DCFPyL     Injection in patients with at least high risk prostate cancer who are planned for radical     prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or     metastatic disease willing to undergo biopsy (Cohort B).   "
23245|NCT02981355|"     This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold     with microfracture versus microfracture alone on short and long term clinical benefit in     patients with cartilage lesions of the femoral condyle requiring operative management.   "
23246|NCT02981342|"     The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in     combination with other drugs versus standard of care in participants with previously treated     metastatic pancreatic ductal adenocarcinoma (PDAC).   "
23249|NCT02981303|"     Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in     subjects with advanced melanoma or metastatic TNBC      Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination      Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors     (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune     systems in those subjects who have failed 1st line therapy      The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12     subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC)     subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in     Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting     dose is 4 mg/kg for Imprime PGG. In the event there are a total of > 4 (or > 33%) of subjects     with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg,     and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects.     For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma     subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must     be observed in order to proceed to Stage 2.      Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For     the dose that meets the Stage 1 safety criterion, success will be declared if at least 4     amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42     subjects with TNBC achieve an objective response.   "
23250|NCT02981290|"     This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way     crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites     from 4 tablet formulations in healthy participants.   "
23251|NCT02981277|"     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various     bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often     reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be     significantly improved with control of cough. Use of sedation during bronchoscopy has been     reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is     routinely performed at many centres including ours.      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is     limited literature on the efficacy of transtracheal/transcricoid injection versus spray as     you go method for lignocaine delivery to the airways during bronchoscopy. This study would     help to determine the procedure comfort for the patient while using the     transtracheal/transcricoid method vs the spray as you go method.   "
23252|NCT02981264|"     Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly     performed for diagnosis of mediastinal pathologies. The procedure can either be performed     under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients     tolerate the procedure well although cough is often reported as a distressing symptom.     Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia.     There is limited literature on the efficacy of transtracheal/transcricoid injection versus     spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study     would help to determine the procedure comfort for the patient while using the     transtracheal/transcricoid method vs the spray as you go method.   "
23258|NCT02981186|"     The study is a prospective randomised controlled study. The patients get monolateral IOL     implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs     consisting of the same optical design. The difference between the IOLs is the material     (hydrophilic and hydrophobic).      To decide which eye receives POD F and which eye receives POD F GF, a randomization table     will be provided to the principle investigator.   "
23259|NCT02981173|"     The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen     in cluster headache. Subjects will be randomized to receive oral placebo, low dose     psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days.     Subjects will maintain a headache diary prior to, during, and after the pulse regimen in     order to document headache frequency and intensity before, during, and after the pulse     regimen.   "
23260|NCT02981160|"     The purpose of the research is to determine energy expenditure rates and diet and/ physical     activity metabolic features of an individual using current state technologies and a new     technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot     study which intent is to validate this device for use in the weight loss patient population.      This study will involve research of metabolic physiological parameters that are measured     through the breath of the individuals, together with other physical parameters (weight,     height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood     pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary     physical activities. The study will involve withdrawn of breath samples at resting     conditions, and under diets or physical activities regimes.      This instrument will assist our patients in terms of tailoring their diet/nutrition through     their weight loss journey prior and after surgery. As a new technology, it will be an     excellent tool for compliance assessment and engagement with the Weight Loss Program as well     as for long term follow up.   "
23261|NCT02981147|"     The purpose of this study is to investigate the efficacy of Phytus in Acute Cough   "
23262|NCT02981134|"     The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for     prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation     for coronary artery disease.   "
23263|NCT02981121|"     The investigators will study prevention effect of Life style modification on diabetes     mellitus comparing with conventional management and Metformin administration.   "
23264|NCT02981108|"     This is a Phase 1/2, open-label, multicenter study of HS-10296 with dose escalation, dose     expansion and extension cohorts in locally advanced or metastatic non-small-cell lung cancer     (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor     receptor(EGFR) tyrosine kinase inhibitor (TKI) agent. The study is designed to evaluate     safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally     (PO) administered HS-10296. The overall study design is shown in the flow chart below, which     consists of 3 phases: dose escalation, dose expansion and extension cohort.   "
25603|NCT02950558|"     This pilot study will test the hypothesis that prolonged regional peripheral nerve block will     reduce development of chronic pain in patients undergoing surgery for ankle fracture compared     to standard of care. Subjects will be followed for one year.   "
23265|NCT02981095|"     Investigators aimed to evaluate the impact of bupivacaine administration into the surgical     field after total thyroidectomy on post-operative pain and analgesic requirement with a     double-blind, prospective, clinical, randomized study.      Pain assessment was performed with the visual analog score (VAS). Participants were     pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One     group received a 10 ml of bupivacaine solution while the other group was treated with the     same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total     thyroidectomy procedure. All participants were anesthetized and operated with the same     anesthesia and surgical team.   "
23266|NCT02981082|"     A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic     Sclerosis-Pulmonary Hypertension (SSc‐PAH) patients. The study will determine safety and the     primary outcome variability for DMF in treating SSc‐PAH; the primary outcome of clinical     efficacy in this pilot trial will be improvement in 6‐minute walk distance (6MWD).   "
23267|NCT02981069|"     In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous     glucose production) and plasma glucose concentration in diabetic subjects. Researchers will     examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and     fall in plasma glucose concentration.   "
23268|NCT02981056|"     The objective of the study is to investigate the effects of different skincare regimens on     infants (0-6 months old at the start of the study), specifically focusing on moisturization     effect. Outcome measures include moisturization, skin pH, skin barrier, physiological     parameters, reactivity and skin microbiome.   "
23269|NCT02981043|"     Clinical studies so far have been limited, and larger volume and multi-center studies studies     are needed. The purpose of this pilot study is to look for a clinical correlations between     the aggressivity panel developed from biomarkers thought to affect the progression or     aggressivity of endometriosis, pain and quality of life.      Our goal with the study is find a correlation between the aggressivity of endometriosis     with clinical factors determined in our study questionnaires. The aggressivity panel was     pioneered by the EndoDiag lab in France, and was created using markers thought to affect the     activity or progression of endometriosis. This information could lead to a better     understanding of the disease, and ultimately lead to more targeted therapies.      If a patient returns for a second surgery we will ask their permission to use their slides     from their first and seconed surgery to compare. The tissue that is being removed during the     surgery as standard of care to make slides for the research study (there will not be an     endometrial biopsy performed for research purposes with the second surgery). The slides from     surgery 1 & surgery 2 will then be compared.      If a clinical correlation is found with the aggressivity panel, the goal would be to create a     local lab and tissue bank here in the United States that could provide a basis for     collaborative national (even international) research. Also, if a correlation is found, future     investigation will look at correlations of the aggressivity panel and fertility outcomes.     Results of this pilot study will help to direct studies of treatment protocols of the various     stages of aggressivity of endometriosis.   "
23270|NCT02981030|"     The study will examine how a simplified outpatient medical abortion procedure using     mifepristone and misoprostol, with the option to take mifepristone at a place of woman's     choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral     administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with     gestations through 70 days, as well as the acceptability of this method.   "
23271|NCT02981017|"     We propose a randomized, single-blinded, prospective trial in order to evaluate the efficacy     of the Cook Biodesign ENT Repair graft in improving outcomes after the Draf III or Endoscopic     Modified Lothrop procedure. The Cook Biodesign ENT Repair graft is a porcine intestinal     submucosal xenograft which has been FDA approved for use as an adjunct to natural healing     process in the sinonasal cavity. The Draf III or Endoscopic Modified Lothrop involved     creating a large unified drainage pathway for refractory frontal sinusitis. After the     procedure is completed, there is exposed bone along the frontal beak region which can become     a nidus for inflammation, crusting and eventual scarring, leading to stenosis or even     complete blockage of the frontal sinuses. The Cook Biodesign will be used to cover this     exposed bone in order to potentially reduce the inflammation, crusting and scarring and     possibly improve outcomes.   "
23272|NCT02981004|"     The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing     the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for     the prediction of hemodynamic outcome. The results may possibly guide future valve size     selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)   "
23273|NCT02980991|"     The study is a prospective, single-center, open-label, single-armed, phase II clinical trial.     The aim of the study is to evaluate the radiological response rate (RR) of 2 cycles of     neoadjuvant chemotherapy with pemetrexed and cisplatin in patients with resectable stage II     and IIIA lung adenocarcinoma.   "
23274|NCT02980978|"     This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED     randomized control trial. The study is being conducted by the Minneapolis Heart Institute     Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical     Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).      The study will examine the impact of a registered dietitian-led, primary care integrated,     telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual     care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c     <8%, not using tobacco and taking an aspirin as appropriate.   "
23275|NCT02980965|"     This was an open-label, randomized controlled trial that aims to compare the efficacy and     safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant     chemotherapy alone in ER-positive, HER2-negative breast cancer.   "
23276|NCT02980952|"     The aim is to assess the impact of physical inactivity on muscle amino acid balance. In     addition, we will evaluate how the diet and/or a pharmacological intervention designed to     manipulate lipid metabolism (acipimox) will modulate muscle amino acid balance.   "
23298|NCT02980666|"     The purpose of this study is to determine if an investigational treatment (teduglutide) is     safe and effective in Japanese children (age 1 through 15 years of age) with SBS who are     dependent on parenteral support. This study will also evaluate how teduglutide moves through     the body (pharmacokinetics) and how it affects the body (pharmacodynamics).   "
23277|NCT02980939|"     During exercise in the heat, there is a need to replenish fluids in order to avoid     dehydration and decrease the risk for heat illness. What drives this urge to drink is the     thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before     there is a replenishing of fluids. However, there is little scientific evidence of where     thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself     influence exercise performance. Further, during rehydration studies, it is very difficult to     successfully blind a subject to their drinking/hydration protocol. Previous studies that have     blinded a subject to their drinking have used various methods such as intravenous fluid     administration and/or nasogastric tubes. Therefore, the purpose of this research is to     examine the mechanistic roles thirst inhibition plays while exercising in the heat while     undergoing intravenous fluid administration. Specific attention will be directed to the     cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular,     thermoregulatory, and perceptual measures are shown in the diagram below.   "
23278|NCT02980926|"     The purpose of this study is to determine if a shorter-acting spinal anesthetic called     mepivacaine has advantages over a longer-acting medication called bupivacaine.   "
23279|NCT02980913|"     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the     elderly population.      Topically administered lubricants are the basis for treatment of this disease. Relief of     symptoms in patients with moderate to severe dry eye disease is usually reached by the use of     artificial tears during the day. Nighttime relief is often achieved by substances known to be     more adhesive to the ocular surface, such as gels.   "
23280|NCT02980900|"     The present study will assess the effect of the type and timing of protein ingestion 6 days     prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of     muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.   "
23281|NCT02980887|"     It is recognized that patients with various forms of heart and lung disease exhibit varying     degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular     dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not     well understood. Rapid advances in high throughput omic methodology, combined with powerful     bioinformatics and network biology capability, have created the opportunity to conduct     studies that broadly search for homologies and differences across the spectrum of disease     states associated with pulmonary hypertension, and determinants of the spectrum of right     ventricular compensation that accompanies these conditions   "
23282|NCT02980874|"     This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12     months duration in treatment naïve subjects with RVO.   "
23283|NCT02980861|"     Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The     application of minimally invasive surgery for advanced gastric cancer is gaining popularity.     The investigators aim to compare the safety and feasibility of LTG and OTG for advanced     proximal gastric cancer.   "
23284|NCT02980848|"     This Beast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational     pragmatic comparative effectiveness research study using high-quality, prospectively     collected data from BCSC registries to generate evidence on how breast density should be     integrated into decision making around breast cancer screening and preoperative diagnostic     work-up. We will augment existing BCSC registry infrastructure with additional prospective     data collection and collection of patient reported outcomes (PROs), CISNET modeling of     long-term screening outcomes, and qualitative data from focus groups with women represented     in two aims.   "
31820|NCT02869243|"     The purpose of the study is to evaluate the feasibility and safety of intra-tumor and     interstitial therapy with hBMP4 in increasing doses in patients with progressive and/or     multiple recurrent Glioblastoma multiforme (GBM).   "
23285|NCT02980835|"     Intercostal nerve block, performed under the guidance of videoscope, is a part of standard     anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this     double-blind, prospective, multi-center, randomized, controlled clinical trial the     investigators aim to compare preemptive versus post-closure intercostal injection of     ropivacaine in controlling post-video-assisted thoracotomy pain.   "
23286|NCT02980822|"     Purpose: The incidence of surgery for Degenerative lumbar Disc Disease (DDD). According to     the national spine registries in Sweden, Norway and Denmark, there is a difference in     surgical incidence between these countries. The cause for this difference is not known. It     may reflect a difference in incidence of lumbar disc hernia, but with a similar     socio-economic and ethnical background in these countries, it is more likely that the     differences are due to varying surgical indications. Comparing indications for surgery,     patient reported outcome and factors predictive for outcome after surgery for lumbar disc     decease in these countries could provide information about optimal indications for surgery.      Hypotheses: (i) there are no differences in patient-reported outcome after surgery between     these countries, (ii) there are no differences in indications for surgery between these     countries and (iii), factors that predict outcome are similar in these countries.      Method of research: By using data from three Nordic national spine registers, investigators     will compare baseline data, indications for surgery and patient reported outcome one year     after surgery for lumbar disc decease. Register based studies have advantages such as large     sample sizes, reflecting real life, but they also have limitations such as lower follow-up     rates than clinical trials. A non-response analysis will be performed to take this into     account.   "
23287|NCT02980809|"     The purpose of this study is to determine whether topotecan plus apatinib are superior to     topotecan alone as second-line therapy in small-cell lung cancer.   "
23288|NCT02980796|"     Participants will complete 11 sessions. These include screening, 5 sessions where exercise or     rest (according to group assignment) are paired with practice of a motor task, MRI and     Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to     assess neuroplasticity (ability for the brain to reorganize and create new connections).   "
23289|NCT02980783|"     This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic     radial cheek line skin depressions.   "
23343|NCT02980081|"     There are only few recognized indications for the realization of plain abdominal X-rays in     the emergency departement.      The objective of this study is to explore the reasons for abdominal plain X-rays prescription     in the Emergency departments (EDs) of two hospitals.   "
23290|NCT02980770|"     Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common     conditions in obesity, which may influence the prognosis in patients undergoing surgery.     There is a need for simple screening tools to identify such patients at high risk. The     current multicenter observational study aims to investigate occurrence of OSA and OHS in     obese individuals undergoing elective abdominal surgery and further address its impact on     perioperative and postoperative complications.   "
23291|NCT02980757|"     The main purpose of this study is to assess comparative bioavailability of two test     formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified     release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of     Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg     gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15     healthy adult subjects under fasting conditions. The second aim is to asses the safety of     subjects and to determine other pharmacokinetic data.   "
23292|NCT02980744|"     The traditional approach to physical activity promotion in people with stroke has always     emphasized activities of a moderate-to-vigorous intensity (i.e. moving enough to breathe fast     and break a sweat). For many people with stroke who often have difficulty with walking,     achieving that intensity of activity is difficult. The result is that people with stroke     spend over 80% of their day in sedentary behaviours (too much sitting). A growing body of     research shows that too much sitting has negative effects on health including larger waist     circumference, unhealthy levels of blood glucose and insulin, heart disease, lower levels of     functioning, and premature death.      This project tests a new approach to activity promotion that focuses on increasing     light-intensity activity throughout the whole day while reducing sitting time. The new     intervention is titled STand Up Frequently From Stroke (STUFFS) and is aimed at increasing     self-confidence among people with stroke to sit less, stand up and walk around at frequent     intervals during the day. Studies in the general population have shown that standing up and     walking around frequently are beneficially associated with health indicators (lower waist     circumference, lower blood fat and glucose levels). Encouraging people with stroke to reduce     sitting and increase light-intensity activities appears feasible and sustainable and might be     a first step to increase their daily energy expenditure.   "
23293|NCT02980731|"     The purpose of this open-label, single-arm study is to evaluate the impact of venetoclax on     the quality of life of participants with chronic lymphocytic leukemia (CLL; a type of cancer     affecting the blood and the bone marrow) including those with the 17p deletion or TP53     mutation (local lab assessed) OR in CLL participants who have received prior B-Cell Receptor     Inhibitor (BCRi) therapy. The starting dose of venetoclax is 20 mg once daily. The dose must     be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants     may continue receiving venetoclax for up to 2 years. After the treatment period, participants     may continue on into a 2-year follow-up period.   "
23306|NCT02980562|"     Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has     proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation.     However, currently available aqueous purgative formulations are poorly tolerated. The aim of     this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg)     formulation to determine the quality of bowel cleansing and patient tolerability.   "
23364|NCT02979808|"     This study is designed as an open, prospective, non-controlled, qualitative, multicentre     study of a novel transanal irrigation system performed in a population of 150 subjects     suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is     expected to last for a total of 1 year (treatment period) with a planned 12- month     recruitment period and three scheduled site visits.   "
23378|NCT02979626|"     The purpose of this study is to determine whether a moderate-severe endpoints (including high     fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary     complications are predictive of hospitalization, intensive care admission, antibiotic use and     other complications in children under 8 years of age.   "
23294|NCT02980718|"     Awareness of the sense of smell in the western population has been low. Most people do not     think about the consequences of absence of smell (anosmia). Reduction in sense of smell     (hyposmia) can influence everyday life. In situations of stress anosmia can be life     threatening for example when there is a fire. Cooks may lose their job. Not being able to     enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction     (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of     the nose and sinuses or head injuries. OD may be congenital, age related or associated with     neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the     first symptom of both Parkinson's and Alzheimer's disease several years before the mental     changes occur.      Knowledge and focus on OD has until recently been low among most physicians and treatment     options have often not been available. Different approaches to improve OD have been tried     with variable effect depending on the cause of OD. There are studies on corticosteroids, zinc     gluconate and vitamin A. In recent years, olfactory training has been launched as a promising     treatment option. Most studies with olfactory training are done with patients with OD. A     recently published review describes 10 studies with olfactory training among 639 patients and     concludes that daily stimulation with odorants (odor concentrate) over a limited period time     is a promising treatment. The suggested duration of olfactory training varies from 3 to 14     months. Different intensities of olfactory training were compared in patients with post-viral     OD. Olfaction was more improved by the high concentration of odorant than by the low     concentration.      A small number of studies have shown that the olfactory nerve to some extent can be trained     in persons with normal sense of smell, but we need more experience and structured studies to     be able to conclude with greater certainty about the effect of olfactory training in this     population.      This study examines whether intensive olfactory training improves the sense of smell more     than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines     self-evaluation of olfactory function.   "
23295|NCT02980705|"     This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the     efficacy and safety of SUNPG1622.   "
23296|NCT02980692|"     This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to     demonstrate the safety and efficacy of SUNPG1623   "
23297|NCT02980679|"     A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of     the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct     imaging and measurement of thyroid uptake.      Doctors and researchers at the University of Alberta have developed a new method of producing     99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and     Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new     production method will provide another source of 99mTc Pertechnetate. The aim of this study     is to confirm that CTC is safe and can be used interchangeably with G-PERT.   "
28112|NCT02917759|"     Patients having surgery to remove a liver or biliary tissue mass will have a tissue sample     collected and stored for future research. A blood sample may also be collected at the time of     enrollment.   "
23299|NCT02980653|"     Primary Objective:      To evaluate the population prevalence of critical body weight loss ( more than 5% from     baseline) in patients with Head and Neck cancer.      Secondary Objectives:      To evaluate the impact of appetite, and performance status; To evaluate the change of quality     of life (QoL); To evaluate the incidence of infection and hospitalization; To evaluate the     safety profiles   "
23300|NCT02980640|"     The Swiss Multiple Sclerosis Registry is a national, patient-centered registry with the aim     to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of     persons living with MS in Switzerland.   "
23301|NCT02980627|"     Individuals with type 1 diabetes who intentionally omit insulin to lose weight are at high     risk for diabetes-related medical complications and premature death. Conventional eating     disorder (ED) treatments are not as effective for these patients, suggesting that they need a     more tailored treatment approach and one that includes intervention at the time and place     when they are making decisions about their diabetes self-management. The goal of treatment     development project is to modify an existing mobile application (app) for EDs (Recovery     Record; RR) to address the unique needs of adults with type 1 diabetes (T1D) who     intentionally omit their insulin for weight control, and test whether app-supported     individual treatment decreases eating disorder (ED) symptoms and improves metabolic control.     The investigator will also gather preliminary data on the impact of the intervention on     health care utilization and costs and calculate attrition to assess feasibility.      The investigators hypothesize that (1) participants will evidence significant decreases in     mean blood glucose, (2) participation in routine medical care will increase and emergency     visits will decrease, (3) the percentage of time participants are hyperglycemic will     decrease, (4) participant scores on the DEPS-R will decrease and (5) participant scores on     the EDE will decrease.   "
23302|NCT02980614|"     MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its     branches inside the same sequence. The objective of the project is to compare the regurgitant     fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in     repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization     will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA     flow +RightPA flow ? ).   "
23303|NCT02980601|"     The purpose of this research study is to compare the forearm free flap of patients with a     traditional split thickness skin graft and those repaired with Integra (a skin substitute     that helps to provide wound closure) and a split thickness skin graft. The study team will be     looking at the subject's satisfaction with how the skin graft site looks and how well the     skin graft site is functioning.   "
23304|NCT02980588|"     Poorly glycemic control in critically ill patients can increase their mortality, while safe     and efficient glucose control is laborious and time-consuming. The Space Glucose Control     which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose     target range safely and effectively through regulating insulin dose rate, and decrease the     glucose variability. This study is a random controlled trial involving the patients with     sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of     blood glucose control between SGC directed and conventional treatment. At last, the trial     results can determine whether the Space Glucose Control can control blood glucose safely and     effectively in the patients with sepsis in intensive care units.   "
23305|NCT02980575|"     This study is aimed at determining whether listening to music during exercise will improve     health-related outcomes for individuals with chronic obstructive pulmonary disease (COPD).     Half of the participants will listen to music while they exercise and half will not listen to     music. The study will follow participants during their pulmonary rehabilitation program and     for 6 months following completion of the program.   "
23307|NCT02980549|"     Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is     defined as a dissociated state of consciousness, occurring on awakening from general     anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not     consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem     in pre-school children, with estimates of the incidence ranging from 10-70% of children in     this age group. These children are agitated, seemingly unaware of their surroundings, and     typically do not respond to parents or caregivers. They are therefore at risk for     self-inflicted traumatic injury and complications secondary to disruptions of intravenous     lines, surgical incisions, or drains. Children with ED typically require more resources in     the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED     would allow for better allocation of resources in the post-anesthetic care unit (PACU).      The peak incidence of ED in children occurs in the same age range at which the peak incidence     of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the     description of ED; the American Academy of Sleep Medicine defines parasomnias as undesirable     physical events or experiences that occur during entry into sleep, within sleep or during     arousals from sleep. Parasomnias can be diagnosed using a sleep questionnaire.      The purpose of this pilot study is to determine the incidence of ED and PS in our population,     in order to determine the number of patients necessary to enroll in a larger study to either     confirm or reject the hypothesis that ED and PS are correlated.   "
23308|NCT02980536|"     The purpose of this study is to evaluate the mutation pattern of epidermal growth factor     receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient     with liquid biopsy.   "
23319|NCT02980393|"     This study is to assess whether a lifestyle intervention with diet, exercise and counselling     in young patients will have a positive influence on their weight and overall well-being. This     study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart     disease, and have been identified being overweight or obese. A total of 40 individuals will     participate in this study. The study duration will last for 1 year.   "
23328|NCT02980276|"     The overall objective of the EMERGE trial is to determine whether metformin + usual care,     compared to placebo + usual care (introduced at the time of initial diagnosis of GDM),     reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive     maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for     women with Gestational Diabetes Mellitus.   "
23309|NCT02980523|"     A randomized, double blind, phase II multicenter trial whith the objetive of assess the     safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens,     versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.      Number of participants: 300 eyes, 60 per group.      Criteria for evaluation:      Measurements of effectiveness: Main efficacy criterion It will be determined as effective if     there is a reduction in number or species of bacterial flora by comparing the basal culture     against the final culture among the five different patient groups.      Reduction or absence of infection with the clinical evaluation through signs and symptoms.      Safety Measurements: it will be determined by visual acuity and adverse events Patients     recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken     into account at the time of baseline, however the study medication and procedures will be     applied and performed in both eyes to protect the healthy eye.      The study is divided into the following evaluation periods:      Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23)     for the evaluation of adverse events.      Subjects will be allocated to any of the following regimen dosages:        -  PRO-157 1 drop 2 times daily        -  PRO-157 1 drop 3 times daily        -  PRO-157 1 drop 4 times daily        -  Moxifloxacin 1 drop 3 times daily        -  Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An          artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes          before instillation of study drug, during study period.      Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in     which each of the variables is described, the ITT population will be constituted by all     subjects recruited who have received at least one dose of the study, the PP population will     be the subset of ITT composed of all subjects without any major deviation from the protocol     and the bivariate analysis will be performed in this group.      Continuous quantitative variables are expressed and presented by measures of central tendency     and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal     variables are presented by means of frequencies and proportions. The level of significance     was an alpha of 0.05 or less.   "
23310|NCT02980510|"     National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus     mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF     status from circulating DNA analysis.      Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.   "
23311|NCT02980497|"     The objective of this randomized, single-center, examiner-blind, controlled, parallel group,     six-month clinical study is to compare the antiplaque/antigingivitis potential of a     no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing     mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be     included.   "
23312|NCT02980484|"     This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial     magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain     injury (TBI). Half of patients will receive active treatment, while the other will receive a     sham treatment with the option of receiving open-label active treatment afterwards.   "
23313|NCT02980471|"     The purpose of this study is to demonstrate the correlation of the Compensatory Reserve Index     (CRI) numeric and graphical trend readings to intravascular volume changes as compared to     graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots) and to     stroke volume as measured by the Nexfin monitor during the same graded blood removal period.     Enrollment includes both men and women.   "
23314|NCT02980458|"     The present study will be conducted in order to compare the bioavailability of the generic     Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed     Reference product (Ferriprox® film-coated tablets, Apotex Europe B.V., Germany) both     containing 500 mg deferiprone. For this issue the pharmacokinetics will be characterised     after single dose administration of each one tablet.   "
23315|NCT02980445|"     The purpose of this study is to determine whether improved outdoor time has an effect on the     onset and progression of myopia in children.   "
23316|NCT02980432|"     The investigators previously shown that a rotating optokinetic stimulus results in shifts of     the subjective visual vertical in healthy human subjects. However, the origin of these shifts     is still poorly understood. Both torsional displacement of the eyes and a shift in the     internal estimate of direction of gravity have been proposed as potential explanations. Here     the investigators use a vision-independent setup to differentiate between these two     hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if     torsion triggers the shift.   "
23317|NCT02980419|"     The long-term goal of this research is to advance the investigators knowledge of how the     brain combines the information of multiple sensory systems coding for spatial oriention and     how adaptation to vestibular imbalance influences spatial orientation. In healthy human     subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans     show a systematic bias in perceived direction towards the previous roll-tilted position     (so-called post-tilt bias). This effect could either be related to adaptation to the     roll-tilted position (shifting the null position) or it could be related to changes in     torsional eye position due to prolonged static roll-tilt (ocular counter-roll). While in the     first case a post-tilt bias is predicted independently of the experimental paradigm used, the     second hypothesis predicts a post-tilt bias only if retinal cues are integrated. In order to     evaluate these hypotheses, the investigators will assess perceived vertical using both     vision-dependent and vision-independent paradigms.   "
23318|NCT02980406|"     In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric     motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers and 20     patients with irritable bowel syndrome (IBS) will undergo respectively four and two/three     pressure measurements of the stomach after an overnight fast as a measure for gastric     motility. During this pressure measurement, which takes approximately 4 hours, one of four     FODMAP or control solutions will be administered directly into the stomach through a     nasogastric tube. Administration will be stopped when the participant is fully satiated. The     four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a     fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients,     only the fructan and glucose solution will be tested, where after they can choose to come for     a third visit to test the fructose solution. The solutions will be tested on separate     occasions in a randomized order.      During the pressure measurement, participants will be asked to complete several     questionnaires: (1) a gastrointestinal symptom questionnaire to assess their gastrointestinal     symptoms, (2) a satiation questionnaire during infusion of one of the solutions, (3)     psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible psychological     effects of FODMAP infusion.      The investigators hypothesize that there will be differences in gastric motility between     healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal     symptoms will be increased in IBS patients, and that FODMAP infusion will have more     psychological effects in patients than in healthy volunteers.   "
23320|NCT02980380|"     Despite partial success, communication has remained impossible for persons suffering from     complete motor paralysis but intact cognitive and emotional processing, a state called     complete locked-in state (CLIS).Very recently NIRS was successfully used to investigate the     functional activations in the cortex of a CLIS patient in response to auditorily presented     stimuli containing correct or incorrect statements and open questions. The hemodynamic change     in the motor cortex of the CLIS patient was recorded across many sessions spread over more     than a year and was used to train a classifier to predict the yes and no answering     pattern of the CLIS patient who was previously trained to use an electroencephalography (EEG)     based brain computer interface (BCI) without success. The trained classifier was able to     provide online feedback (your answer was classified as (in) correct) to the patient with     performance rate of 71.76%. This is the first carefully documented case of communication in a     CLIS patient with BCI, which holds promise and raises the hope for communication in CLIS.     Hence, to further validate the preliminary findings of our lab and refine the technology of     functional near infrared spectroscopy (fNIRS)-based BCI for communication in CLIS-patients     extensive studies will be carried out on CLIS patients using fNIRS based BCIs.   "
23321|NCT02980367|"     The primary objective of this study is to determine in patients with non-acute (greater than     4 months since injury) Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of     non-surgical management [Rehabilitation] (with option for later ACL reconstruction, only if     required) is more clinically effective and cost effective than a strategy of surgical     management [Reconstruction].   "
23322|NCT02980354|"     Stroke is a life-threatening medical condition that occurs due to a sudden disruption of     blood supply to the brain. Although it may affect all age groups including children, the     elderly are at a greater risk of having strokes. Indeed, three-quarter of all strokes are     seen in people over the age of 65. Unfortunately, due to short therapeutic window (4.5 h of     stroke onset), only 2-3% of patients can receive the currently available single medical     therapy with rt-PA, a clot-busting agent. As recent studies show that bone marrow-derived     endothelial progenitor cells, a type of stem cells, may migrate to the site of injury to     repair the damaged brain vessels and tissue, it is possible that their numbers and functional     capacity may determine the clinical outcome of stroke patients i.e. severely disabled,     moderately disabled or no signs at all. This study will assess these parameters in elderly     stroke patients compared to their age-matched stroke-free counterparts and healthy young     volunteers.   "
23323|NCT02980341|"     This is an open-label, three-part, non-randomized, multiple-dose study to evaluate safety,     tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast     cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines     a certain type of cancer.      The number of patients and treatment cycles are not fixed in this study. Subjects who     continue to derive clinical benefit from the study treatment in the absence of withdrawal of     consent, progressive disease (PD), or unacceptable toxicity may continue the study treatment     until the end of the trial.   "
23324|NCT02980328|"     This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive     low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary     Incontinence (UI)   "
23325|NCT02980315|"     The purpose of this study is to evaluate the safety of the designed LMP1－CAR －T cells and     determine whether the CAR-T cells are effective in the treatment of EBV associated malignant     tumors.   "
23350|NCT02979990|"     The Learning from Online Video Education (LOVE) study seeks to determine if online     instructional videos on how to administer medication needed for in vitro fertilization (IVF)     help improve the quality of life and reduce stress during the IVF process.   "
23351|NCT02979977|"     This is a single arm Phase II study for patients with recurrent or metastatic squamous cell     carcinoma of the head and neck, who are previously treated with a platinum based regimen or     with an immune checkpoint inhibitor. The primary objective is to evaluate the efficacy of the     combination of cetuximab and afatinib.   "
23376|NCT02979652|"     This study is done to estimate prevalence of the main detectable lung and cardiovascular     complications by an ultrasound realized in room of post-interventional supervision at the     patients whose duration of general anesthesia is superior at one hour after a surgery to risk   "
23377|NCT02979639|"     The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals'     HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age.   "
23326|NCT02980302|"     According to the World Health Organization (WHO), mental retardation (MR) is defined by an     intelligence quotient (IQ) < 70 and touches between 1 to 3 % of the general population.     Profound mental retardation (QI <25), severe (IQ: 25-40) and moderate (QI : 40-50) have a     prevalence of 0,3-0,5% while the prevalence of mild MR, defined by an IQ between 50 and 70 is     evaluated to about 1,5 %.      The origin of MR can be infectious, toxic, traumatic, genetic or environmental. genetic     causes of MR gather the number and structure anomalies of the chromosomes, the genomic     microreorganization, monogenic diseases and more rarely other non Mendelian-inherited     anomalies like print or epigenetic anomalies, mutations of the mitochondrial genome etc...     Genetic causes represents 50% of moderate to severe, whereas environmental factors     (malnutrition, cultural deprivation,...) plays an important role in mild MR.      The main goal of this study is to get an innovative tool (neuronal distinction of iPSC) that     wil allow to study the functionnal impact of mutations uppon genes probably involved in MR     like MYT1L. The main criteria associated to characterisation of the tool by the trial is the     study of the pluripotency of iPSC obtained and to highlight the mutation of the gene MYT1L in     the iPSC.      Neurons from the iPSC of the patient and his father du patient wille also be morphologically     characterised, but also thanks to the expression of specifically neurals genes.      Characteristics of iPSC and neurons from d'iPSC with MYT1L mutation will be compared among     the patient and his father, in relation with the same cells coming from the two witnesses.   "
23327|NCT02980289|"     The study aims to investigate the prevalence and treatment of nausea and/or vomiting in     patients with advanced cancer not receiving chemotherapy or irradiation.   "
23329|NCT02980263|"     The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or     refractory patients diagnosed with active Kawasaki disease, administration of canakinumab     controls fever and acute phase reactants.   "
23333|NCT02980211|"     PURPOSE The purpose of this case series is to clinically, radiographically and histologically     evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive     GBR technique that involves the application of a particulate bone allograft and a     non-resorbable PTFE membrane.      METHODS Subjects with single-rooted teeth indicated for extraction and interested in future     implant therapy for tooth replacement will be recruited on the basis of an eligibility     criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon     clinical examination in order for the subject to qualify for study inclusion. A cone-beam     computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be     obtained prior to tooth extraction. Following minimally invasive tooth extraction and     debridement, the socket will be evaluated to verify the presence of a dehiscence defect     affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using     tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be     trimmed to a size and shape that would allow for complete extension over the existing defect     will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be     grafted with particulate allograft and the access to the socket will be sealed with an     extension of the membrane and an external cross mattress suture. Subjects will be recalled at     1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog     scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and     the exposed area will be left to heal by secondary intention. At 20 weeks after tooth     extraction a second CBCT will be obtained to radiographically evaluate the site for implant     placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks     will be made using the CBCT data to assess changes affecting the bone housing. If the site     has healed adequately, implant placement will be planned at 24 weeks after tooth extraction.     A bone core biopsy will be obtained at the time of implant placement in order to     histologically analyze the characteristics of the grafted substrate. Upon implant placement     with primary stability a healing abutment will be placed and sutures will be given to achieve     primary wound closure, as necessary. Subjects will return for the final study visit at 2     weeks following implant placement to evaluate the healing prior to being referred back to the     restorative dentist.   "
23334|NCT02980198|"     This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα     antibodies (immune response) in adult subjects with dermatomyositis   "
23335|NCT02980185|"     To assess the feasibility, Residual Tumor, complication rate and survival of totally     laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian     Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon     prospective series.   "
23336|NCT02980172|"     All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are     triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale.     At the end of the triage process the triage nurse has to choose an emergency level and a main     presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain     evaluation for 44 out of the SETS 98 presenting complaint.      The primary objective of the study is to determine whether pain is correctly evaluated when     required by the SETS criteria. The secondary objectives are (1) to evaluate whether an     appropriate treatment is delivered when pain is present, and (2) to identify predictors of     pain evaluation and treatment.   "
23337|NCT02980159|"     Due to an increasing number of patients admitted in emergency departments, many patients     cannot be evaluated immediately after their admission. The function of triage liaison     physician was introduced in Spring 2015. The objective of this study is to evaluate the     impact of this new function on patients' flow in the ED.   "
23361|NCT02979847|"     prospective randomized controlled trial      In repeat procedure for persistent atrial fibrillation, Hybrid group (Epicardial ablation +     Endocardial ablation) versus control group (conventional Endocardial ablation)      Freedom from AF/Atrial tachycardia and safety   "
23362|NCT02979834|"     This study aims to investigate average gestational week in which mothers feel the     babies'movements for the first time and maternal-fetal factors affecting this time.   "
23338|NCT02980146|"     Accumulating evidences suggest that colorectal cancer (CRC) progression is not solely     determined by the genetic abnormalities of the tumor cells but also by the host response.     Indeed, recent studies in CRC have associated improved survival with a high number of     tumor-infiltrating (TIL) memory and cytotoxic T lymphocytes, suggesting a link between tumor     progression and in situ T cell response. Gene expression profiling studies have clearly     isolated a well-known subgroup of CRC characterized by microsatellite instability (MSI) CRC,     associated with a strong immune response signature involving both Th1/cytotoxic and immune     evasion pathways. Moreover, the investigators have previously shown that HLA-E/β2m is     overexpressed by tumor cells in roughly 20% of CRC and is associated with a worse prognosis,     most likely due to NK and T effector cell functions upon engagement with the inhibitory NK     receptor CD94/NKG2A. However, our recent results on an enlarger cohort of patients suggest     that if this observation holds true for MSS CRC, HLA-E over-expression is inversely     associated with a good prognosis in MSI CRC. Thus, the phenotype and function of TIL,     depending on the MSI/MSS status of CRC have to be precised. The investigators hypothesized     that in MSI CRC, known to express a high number of MSI-H related frameshift peptides which     represent a pool of tumor specific antigens, HLA-E could present peptides to TCR of non     conventional CD8+ HLA-E-restricted alpha-betaT cells (also expressing CD94), then inducing a     strong antitumor cytolytic activity. Therefore, the aim of this project is to determine the     exact phenotype, function and specificity of the CD94+ TIL in CRC, depending on both the     HLA-E and the MSI/MSS status of tumor cells. These results could impact the clinical practice     as anti-NKG2A monoclonal antibodies or frameshift peptide based immunotherapy that could be     promising new therapeutic options in CRC patients.   "
23339|NCT02980133|"     This study is to evaluate the safety and efficacy of Fluticasone Propionate and Fluticasone     propionate Salmeterol in pediatric patients with a documented history of persistent asthma.   "
23340|NCT02980120|"     The proposed study will investigate whether, on the basis of personality traits and     personality disorders as well as specific cerebral activation patterns shows differences in     adolescent female with anorexia nervosa (AN), bulimia nervosa (BN) and a healthy control     group.   "
23341|NCT02980107|"     The objective of this study is to evaluate the efficacy of infographics, compared to standard     PLS format, in presenting information, in terms of understanding and remembering research     results by consumers.   "
23342|NCT02980094|"     The project aims to study the effects of inclusion of sunflower oil, vitamin E and selenium     in the diet of dairy cows on milk composition and the influence of modified milk on nutrition     and health of elderly. To achieve those goals, two experiments will be conducted, both     lasting 12 weeks. In the first one, 24 cows at the beginning of lactation will be allotted in     a completely randomized block design with a 2 x 2 factorial arrangement of treatments, as     follow: 1) control diet; 2) control diet plus selenium and vitamin E; 3) control diet plus     sunflower oil diet; 4) control diet plus sunflower oil, selenium and vitamin E. This     experiment seeks the development of modified milks through nutritional manipulation of cow's     diet. Concomitantly, in the second experiment, 100 elderly people will receive the four     different kinds of milk produced in the first experiment in a completely randomized block     (gender) design. The selection of the elderly for each group shall be composed clinical     evaluations. Will be conducted biochemical tests before and after supplementation of milk     consumption (serum α-tocopherol, selenium, analysis of fatty acid profile). Assessment of     nutritional status will be made body mass index (BMI) with each participant before and after     the experiment of 12 weeks, including body composition by multifrequency bioelectrical     impedance analysis (BIA), evaluating the strength of pressure of the hand portable     dynamometer, demographics and food consumption. The study of human nutrition and health will     be held in the form of a double-blind study. The second experiment aims to study nutrition     and health of elderly people, as it is expected that milk produced with better fatty acid     profile, vitamin and minerals can improve the inflammatory profile of markers of the elderly.     This project is important for the human population in general, particularly elderly people,     health workers, human and animal nutritionists, and especially for the milk chain, as it has     a potential to develop new dairy products and boost milk consumption.   "
23346|NCT02980042|"     This is a prospective between and within group observational study to determine differences     in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS)     patients who have been administered at least two infusions of rituximab, six months apart and     are willing to be switched to ocrelizumab compared to a 100 patients who are continuing on     rituximab as a comparison cohort from the clinic population treated as part of clinical care.   "
23347|NCT02980029|"     The purpose of this study is to determine if the study drug, TVB-2640, is able to affect     levels of certain enzymes in subject's blood and cause changes in tumor. This study is only     for people who require surgery for their colon cancer.   "
23348|NCT02980016|"     This study is a parallel, two part, open label, individually randomized, pragmatic trial     among HIV-positive individuals. Part A compares a single round of weekly high dose     rifapentine plus isoniazid for three months (3HP) to six months of daily isoniazid (6H). Part     B compares periodic 3HP (p3HP) to a single round of 3HP.   "
23349|NCT02980003|"     Intravascular administration of iodinated contrast media is an essential tool for     cardiovascular imaging and percutaneous coronary interventions. Nonetheless, the increasing     incidence of contrast-induced nephropathy (CIN) has become an important and prognostically     relevant problem along with the spreading of diagnostic and interventional procedures. CIN is     largely dependent on oxidative damage and represents a considerable cause of renal failure,     being associated with prolonged hospitalization and significant morbidity/mortality. The most     effective treatment strategy of this serious complication remains prevention, and several     preventive measures have been extensively investigated in the last few years. Pre-procedural     hydration is the best known and mostly accepted strategy. The administration of sodium     bicarbonate (HCO3) has controversial effects, and is likely to be ineffective when the     infused dose is unable to achieve adequate urine alkalinization. Since alkaline pH suppresses     the production of free radicals, increasing urine pH would be an attractive goal for CIN     prevention. In a randomized clinical trial the investigators will test the hypothesis that     urine alkalinization with either oral or i.v. bicarbonate on top of hydration alone is the     main determinant of CIN prevention in a population of patients with moderate or severe     chronic kidney disease scheduled for coronary angiography and/or angioplasty. If the     investigators, demonstrate non-significant differences in urine alkalinization (primary     endpoint) and incidence of CIN (secondary endpoint) between the bicarbonate groups, a     practical implication will be that oral administration is preferable for practical reasons     over the administration of i.v. bicarbonate.   "
23363|NCT02979821|"     In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with     stage IV lung adenocarcinoma harboring HER2 mutation.   "
23352|NCT02979964|"     Health Quality Ontario (HQO) is the provincial advisor on quality in health care. HQO     currently conducts audit and feedback as a key quality improvement strategy. For example, it     offers physicians working in long-term care homes with access to practice reports detailing     rates of high-risk prescribing in comparison with others in Ontario and suggested change     ideas. Research shows that providing this kind of feedback can lead to improvements in care.     However, the size of these improvements depends how the feedback is presented. For instance,     prior research suggests that how the results are 'framed' and what sort of benchmark the     recipient is compared to may each affect how the physician will respond. This factorial trial     tests each of these aspects of feedback design in the context of practice reports that     nursing home physicians have already signed up to receive quarterly.   "
23353|NCT02979951|"     The purpose of this European, multicentric, prospective, non-interventional study is to     document and evaluate the efficacy and safety of the treatment of severely infected patients     with intravenously administered fosfomycin, including patients with osteomyelitis,     complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial     meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue     infection, endocarditis or other infections, each as far as covered by the respective     nationally relevant SmPC.   "
23354|NCT02979938|"     In this prospective observational study the investigators will report on 20 male subjects     with proven WHO-classification Zika infection. These subjects will be followed up for a     maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV)     in semen over time.   "
23355|NCT02979925|"     The proposed study will set the foundation for future multi-center studies. To validate tMS     as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with     PTP-NP and improving their overall functions.   "
23356|NCT02979912|"     Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous     platelet lysate.   "
23357|NCT02979899|"     This is a study of TRC105 in combination with standard dose pazopanib compared to single     agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g.,     metastatic or bulky disease, and disease for which surgical resection would carry an     unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.   "
23358|NCT02979886|"     Gonadotropin-releasing hormone analogue (GnRH-a) long protocol is a protocol for pituitary     down-regulation in IVF. However, it is common in clinic that some patients are hypersensitive     to pituitary down-regulation and have pituitary oversuppression, resulting in prolonged     ovarian stimulation and increased consumption of exogenous gonadotropin(Gn). On the other     hand, some patients may have insufficient pituitary down-regulation, which can affect the     synchronization of ovarian follicles and consequently reduce the number of oocytes     retrievable and lower the pregnancy rate. The differences in responses to GnRH-a among     patients may be associated with the SNP of their GnRH receptor genes. It has been reported     that mutations in GnRH receptor genes could change their binding affinity to the ligands,     thus affecting the outcome of pituitary down-regulation. So far 20 non-synonymous mutations     on the GnRH receptor genes have been reported, which can affect the function of GnRH receptor     and are highly associated with disorders such as endometriosis and sexual precocity. However,     the correlation between the SNP of GnRH receptor genes and the outcome of pituitary     down-regulation in IVF has not been reported.      The purpose of this study is to analyze the correlation between single nucleotide     polymorphism (SNP) of GnRH receptor genes in infertile female patients and the extent of     pituitary down-regulation by short-acting GnRH-a long protocol, with the goal to achieve     individual down-regulation protocols based on the patients' SNP haplotypes of GnRH receptor     genes and to improve the success rate of assisted reproductive technology.   "
23359|NCT02979873|"     Background:      People with severe aplastic anemia (SAA) do not make enough red and white blood cells, and/or     platelets. Their body's immune system stops the bone marrow from making these cells. The     treatment cyclosporine leads to better blood counts. But when this treatment is stopped, the     disease may return in 1 in 3 people. The drug sirolimus may help by suppressing the immune     system.      Objective:      To evaluate and compare the usefulness of sirolimus in preventing aplastic anemia from     returning after cyclosporine is stopped, compared with stopping cyclosporine alone.      Eligibility:      People ages 2 and older with SAA who:      Have responded to immunosuppressive therapy that includes cyclosporine, and continue to take     cyclosporine      Are not taking drugs with hematologic effects      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Bone marrow biopsy: The area above the hipbone will be numbed. A thin needle will remove      some bone marrow.      Participants will be randomly assigned to a group. All will stop cyclosporine. Group 1 will     take sirolimus by mouth at the same time each day for 3 months with close monitoring. Group 2     will not receive the study drug but will be monitored closely.      Participants will have clinical tests for the first 3 months:      Weekly blood test      Monthly fasting blood test      For group 1, measurements of sirolimus in the blood every 1 2 weeks      Participants will have clinic visits at 3 months, 12 months, and annually for 5 years after     the study starts. They may have another visit if their SAA returns. These will include:      Blood and urine tests      Bone marrow biopsy   "
23360|NCT02979860|"     Enhancing children's sleep duration and/or timing may represent a novel approach for weight     regulation and prevention of T2DM. The proposed study will assess how experimental changes in     children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African     American children ages 8-11 years old who sleep approximately 9.5 hours or less each night     will be enrolled into a 4-arm randomized controlled pilot to compare three experimental     manipulations in children's sleep to a typical sleep (TYP) control. Experimental arms will     include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45     minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2-     and 4-week follow-up, participants be weighed and measured for height, have body fat assessed     (bod pod), and their blood drawn (following an overnight fast). The pilot will provide     important data on the potential role of sleep in combating disparities in cardiometabolic     risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose     regulation and 2) to determine the effect of changes in sleep on additional measures of     glucose regulation and adiposity.   "
23365|NCT02979795|"     Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading     cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent     chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that     localized radiation not only destroys local tumor but also inhibits the growth of tumor at     the remote site, has been observed. This effect is believed to be associated with tumor     immune response. In addition, other immune checkpoint molecules, such as Programmed cell     death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated     Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after     CCRT, more than 50% of patients were still either having persistent disease or developed     distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this     project, thus, aims at exploring the evolution of factors that may affect the abscopal effect     and immune checkpoint functions in tissues and in blood before and after CCRT.   "
23366|NCT02979782|"     Primary objectives:      Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular     accident (CVA), and delirium after minimal invasive coronary artery bypass grafting     (Endo-CABG).      Secondary objectives:        -  Quality of life, three months after endo-CABG        -  Patient satisfaction with endo-CABG and the tests performed        -  The influence of various demographic and peri-operative variables on neurological          outcome after endo-CABG        -  Incidence of fear and depression, 3 months after endo-CABG   "
23367|NCT02979769|"     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict     movement by locking joints leading to cumulative loss of function and disability. Mouse     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists     such as palovarotene (PVO) to prevent HO following injury. This 24-month study will (1)     continue to follow FOP subjects from France who completed Clementia Study PVO-1A-201; (2)     enroll up to eight additional new French subjects who have achieved at least 90% skeletal     maturity; and (3) evaluate the ability of different palovarotene dosing regimens to prevent     HO in these subjects.   "
23368|NCT02979756|"     A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco     revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in     receiving appropriate care. Based on the results of the situational analysis, the     investigators developed this proposal in close collaboration with the Moroccan research group     on gestational diabetes composed of representatives of the Ministry of Health, researchers,     members of professional organizations and specialists in the domains of endocrinology,     gynecology, neonatal health and nutrition. The investigators opted for an hybrid     implementation effectiveness trial to evaluate both clinical effectiveness of the proposed     screening and initial management strategy and its implementation at the first level of care.      The objectives of this study are thus to evaluate the feasibility of a decentralized strategy     of screening for GDM and the initialization of GDM treatment already through the primary     level of care and to assess its potential for scaling-up. Specific objectives of this study     are to augment universal access to screening and management of gestational diabetes and to     increase the competencies of health care providers at first level health care facilities to     detect, start initial treatment and to improve follow-up of affected women. By comparing     active screening and treatment initiation through first line health facilities with the     existing practices, the investigators would like to explore the effect of the new model on     maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery     complications and birth weight. The investigators will further assess the acceptability of     screening and initial management of GDM through first line health services by health care     providers and by pregnant women diagnosed with GDM and the impact of two different screening     approaches on the lifestyle of affected mothers.   "
23369|NCT02979743|"     The aim of this study is to explore the relationship between brain MRI-metrics and hand     function observed in children with cerebral palsy (CP),compared between baseline and the     third month, and thus determine the early MRI-based neuroimaging predictor of clinical     improvement following therapy in children with CP.   "
23370|NCT02979730|"     The purpose of the study is to compare Emergency Department patients who undergo influenza     testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located     in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who     agree to participate will have their samples randomly assigned to be tested on either at the     core lab, or on the POC device. The current turnaround time for samples sent to the     laboratory is approximately two hours; investigators expect that the point of care device can     reduce this time. Investigators will determine if the time to disposition and the     administration of antibiotics is different in the group undergoing POC influenza testing     compared to those undergoing laboratory-based influenza testing   "
23371|NCT02979717|"     The objective of this study is to determine the effect of a high protein, high fiber     supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high     carbohydrate Control product in healthy overweight and obese subjects. The investigators     hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a     subsequent meal compared to low protein, low fiber.   "
23372|NCT02979704|"     This study will be conducted to assess the status of oxidative stress inflammation and     thrombogenesis in patients with hyperlipidemia and to compare the antioxidative,     anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.   "
23373|NCT02979691|"     Ratiotherapy alone is the current standard treatment for elderly esophageal or     esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly     patients. This study aimed to assess the efficiency and safety of simultaneous integrated     boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by     adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric     cancer patients   "
23374|NCT02979678|"     The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the     development of BR-23 published 1996 the standard therapy of breast cancer has changed. New     therapies brought new side effects and different impact on QoL (quality of life) are not     sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both     from clinical and scientific point of view.   "
23375|NCT02979665|"     anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal     blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on     the overall retinal perfusion from these treatments remain to be answered. The purpose of the     study was to evaluate changes in the retina following anti-VEGF treatment over time, using     structural and functional diagnostic tests.   "
23380|NCT02979600|"     An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent     Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing     patients to regularly increasing doses of allergen. This protocol induces an increase of the     threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction) and     a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins. The     protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut     proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut     that can be found in standard product in France.      The investigators wish to study the evolution of the threshold reactive dose and of the sIgE     of patients that have followed the OTI protocol. All the needed data are available in the     medical records so the study will be conducted on retrospective data.   "
23381|NCT02979587|"     The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™     TPV system.   "
23383|NCT02979561|"     A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa     or warfarin for prevention of recurrent DVT in patients with angiographically confirmed acute     massive pulmonary embolism undergoIng endovascular mechanical fragmentation and thrombolytic     therapy. [RE-SPIRE study]   "
23384|NCT02979548|"     The purpose of the study is to find out the efficacy of an anti-emetic drug, Aprepitant as an     add-on therapy to prevent vomiting in children and adolescents receiving chemotherapy for     leukemia (AML).      Children and adolescents admitted with confirmed diagnosis of AML will be assessed for     eligibility criteria and enrolled in the study. Then they will be divided (randomized) into     experimental and control groups.      Experimental group will receive Aprepitant capsules 1 h prior to chemotherapy on days 1-3 in     addition to ondansetron. Patients will be required to swallow the whole capsule and opening     of capsule will not be permitted. All three doses will be administered under supervision.      Control group will receive ondansetron (0.15 mg/kg) as an intravenous bolus 30 minutes before     chemotherapy followed by every 8 hourly for 8 days. Metoclopramide will be used as a rescue     agent.      The data will be collected from each patient in a proforma from day 1 to day 13 of     chemotherapy. A Diary will be maintained for nausea and vomiting record.      Edmonton's symptom assessment criterion will be used in the diary for assessing severity of     nausea. The NCI guidelines will be used to assess the severity of vomiting based on the data     provided by the patient in the diary.      A modified intention-to-treat population (patients who receive chemotherapy, take one or more     doses of study drug, and have one or more post treatment measurements) will be used for     efficacy analysis. Proportion of patients with complete response will be compared between     patients with or without aprepitant.   "
23393|NCT02979431|"     The primary objective is to evaluate the anti-viral effect and safety of different doses of     inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory     Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity,     pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different     doses of inhaled ALX-0171.   "
23394|NCT02979418|"     This study will implement the validated household-level water insecurity scale developed by     study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a     range of outcomes linked to water insecurity, such as viral load, hydration status, maternal     depression, stress, food insecurity, and cognitive development.   "
23395|NCT02979405|"     Hypotension in patients who are taken to surgery, is a very frequent complication, when the     spinal anesthetical technique is used, associating this with significant adverse effects that     can lead to morbidity specially in the obstetric patient. The objective of the study is     determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance     of hypotension in obstetric patients led to Caesarea under spinal anesthesia.   "
23385|NCT02979535|"     The aim of this study is to investigate the immunogenicity and safety of CYD dengue vaccine     and Cervarix when administered concomitantly or sequentially in healthy female subjects aged     9-14 years of age.      Primary objectives:        -  To demonstrate that the humoral immune response (in terms of geometric mean titers) to          Cervarix after concomitant administration is non-inferior to sequential administration          with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.        -  To demonstrate that the humoral immune response to the CYD dengue vaccine after          concomitant administration is non-inferior to sequential administration with Cervarix          measured 28 days after the last dose of the CYD dengue vaccine.      Secondary Objectives:        -  To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix          after concomitant administration is non-inferior to sequential administration with the          CYD dengue vaccine measured 28 days after the last dose of Cervarix        -  To describe the humoral immune response to Cervarix at baseline and after each dose of          Cervarix in each and any group        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after          each dose of the CYD dengue vaccine, in each and any group        -  To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in          each group.   "
23386|NCT02979522|"     The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as     well as recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent     chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric     participants with advanced stage newly diagnosed Hodgkin Lymphoma (HL).   "
23387|NCT02979509|"     All patients will receive standard medical care and no experimental interventions will be     performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a     well-established procedure commonly used for the investigation of lesions within or adjacent     to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal     gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly     performed with different size and types of aspiration and core biopsy needles.   "
23388|NCT02979496|"     The purpose of this study is to evaluate the effect of daily intake of orange pomace on     gastrointestinal function as measured by stool frequency. Additional outcomes will include     aspects of digestive health, diet quality, and fasting blood glucose and lipid     concentrations. Possible explanations for the mechanism of the pomace will be explored in     microbial ecology analyses.   "
23389|NCT02979483|"     This study assessed the feasibility and effects of an early integrative supportive care     program in patient with Advanced pancreatic adenocarcinoma (aPDAC).   "
23402|NCT02979314|"     Corroboratory behavioral evidence showed interaction effects between vestibular stimulation     and egocentric transformation.      The investigators here examine in healthy participants, whether there are shared brain     mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric     transformation, as well as their interaction.      It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform     egocentric mental transformation.   "
43115|NCT02721329|"     The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP     without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and     Insomnia.   "
23390|NCT02979470|"     The main reason of cancer-related mortality is the spread of cancer cells to distant sites     (micrometastases). However, only a few small groups of tumor cells can metastasize by     acquiring mechanism to decrease the immune response. Changes in the systemic inflammatory     response to the tumor can be measured by blood-based parameters. In particular, the     proportion of neutrophyls- lymphocytes (NL) has been evaluated for predicting the survival of     patients with different types of cancer. The first strategy to treat colorectal cancer (CCR)     is complete resection of the lesion. Nevertheless, some patients experience recurrence,     probably due to residual micrometastases. We have demonstrated that analysis of some     resistance proteins (Tyms / MRP1) in circulating tumor cells (CTCs) may predict treatment     response in metastatic CCR patients (mCRC). We also note that the CTCs kinetics can show     response to therapy. Patients with stage III disease in the colon / rectum, although showing     high cure rate, generally fall locally or remotely and studies with blood markers in this     group of patients is still scarce. Primary Objective: To investigate cells found in the blood     (lymphocytes and neutrophils and CTCs) to verify if they can help in the choice of     anti-neoplastic therapy in patients with advanced colon and rectum cancers. Secondary     objectives: - to evaluate the influence of CTC kinetics in response to treatment of patients     with advanced colon/rectum cancers; - to check the expression of treatment resistance,     invasion and proliferation proteins (Tyms, TGF-βR, MMP-2, β-gal, Ki-67 and CD45) in CTCs and     their correlation with response to treatment; - to check the mRNA expression of the same     genes observed by immunocytochemistry in CTCs and their correlation with response to     treatment; - to quantify CTCs, neutrophils and lymphocytes of patients included in this study     and verify if there are correlation among their rates and progression-free survival. Methods:     there will be collected 10 ml of blood of patients with advanced colon and rectal cancer for     analysis of CTCs, lymphocytes / neutrophils. CTCs will be isolated, quantified and analyzed     after separation by ISET method (Rarecells/France). The marker analysis of these cells will     be done by immunocytochemistry and the gene expression will be assessed by RNAscope. The     quantification of lymphocytes/neutrophils will be made by common blood count in Delboni     laboratory. Expected Results: We propose to show that not only the count and the kinetics of     CTCs, but also their molecular characteristics, can provide relevant information to     clinicians. Hopefully, by quantification of neutrophils and lymphocytes, we will be able to     identify new prognostic blood biomarkers that can direct clinicians to the best therapeutic     choice.   "
23391|NCT02979457|"     The overall aim of the study is to construct a scale that systematically incorporates the     callers' perspective in a degree of worry - scale and to explore the consequences for the     actors in the system - caller, call-handler, and health care system.      This will be done through four independent studies.        1. Is it possible to validate the degree of worry scale with the software system Corti?        2. Does callers' degree of worry relieve after telephone consultation?        3. Does call handlers' awareness of degree of worry affect triage outcome?        4. Is callers' degree of worry a predictor of illness severity?   "
23392|NCT02979444|"     There is considerable evidence that most perinatal women at risk for postpartum depression do     not engage in mental health services, even when referred by home visiting (HV) programs,     primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be     delivered via alternative settings—e.g., HV programs—are essential to prevent the onset of     major depression and worsening of depressive symptoms among perinatal women. This Patient     Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the     Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is     more efficacious than usual care (i.e., home visiting without the MB enhancement). It will     also examine if MB, when led by paraprofessional home visitors, is not inferior to MB     delivered by mental health professionals. The results of this study will inform     decision-making by HV programs regarding provision of MB to perinatal women at risk for     developing major depression.   "
23397|NCT02979379|"     This study is aimed at determining the role of pain in individuals with chronic obstructive     pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is     not known whether pain interferes with an individuals performance in PR, or whether PR     aggravates or relieves pain. Individuals with COPD who report chronic pain and those without     pain will be enrolled in the study.   "
23398|NCT02979366|"     The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised,     non-comparative study. This study is designed in two parts: one part for dose escalation, one     part for dose expansion.   "
23399|NCT02979353|"     This randomized, controlled trial will evaluate the effects of an intervention to reduce     exposure to medications among hospitalized older adults discharged to skilled nursing     facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as     defined by dose reductions and stopped medications, based on a combination of clinical     criteria and patient preferences. The investigators will evaluate the effects of the     intervention on the total number of medications prescribed to patients at hospital and SNF     discharge and at home 90-days after SNF discharge along with the prevalence of eight     geriatric syndromes, medication adherence, and health status.   "
23400|NCT02979340|"     Specific Aim 1. Determine if valid results of non-sedated MRI based assessments of liver     stiffness and lipid content can be obtained in more than 90% of children and young adults     with cystic fibrosis.      Specific Aim 2. Determine hepatic lipid content using the HepaFat sequence and liver     stiffness using MRE. Investigators will compare the results obtained by MRI with PUSH study     grayscale ultrasounds in CF patients with normal, heterogeneous, homogeneous or nodular     (cirrhotic) pattern on ultrasound.      Specific Aim 3. Creation of an imaging core lab to centralize evaluation of MR imaging data,     allow for remote image upload, electronic data storage, and remote image     viewing/interpretation. This infrastructure will be utilized to standardize image post     processing.      Specific Aim 4. Using the longitudinal PUSH study, determine if MRI based imaging improves     discrimination of subjects at risk for progression to advanced CF liver disease (development     of cirrhosis) compared to using US imaging alone   "
23403|NCT02979301|"     The study will examine whether changes in background parenchymal uptake (BPU) on molecular     breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have     previously had high BPU on MBI will be recruited. Participants will take low-dose tamoxifen     for a 30-day period, with post-tamoxifen MBI in order to investigate the impact of tamoxifen     on BPU.   "
23404|NCT02979288|"     In the currently presented trial, investigators aim to evaluate the treatment of the     intermediate vaginal microbiota during the first trimester of pregnancy with vaginal     lactobacilli to restore the normal vaginal microbiota and therewith reduce the rate of PTD.     All pregnant women between 10 + 0 (10 weeks plus 0 days) and 16 + 0 (16 weeks plus 0 days)     gestational weeks in study group will be treated with vaginal Lactobacilli Capsules     containing L. Casei rhamnosus LCR 35   "
23405|NCT02979275|"     Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there     might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker     of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood     samples during the first post-op day.   "
23406|NCT02979262|"     The proposed stage 1 intervention development study is designed to address two significant     co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence     (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce     family violence because SA treatment alone does not result in an end to these behaviors.     Currently available interventions have had little success in reducing male IPV. Fathers for     Change, an integrated outpatient intervention, shows promise as an intervention model     targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers     as a motivation for change and targets factors that are known to trigger SA, IPV and CM:     hostile cognitions and poor emotion regulation. An intervention of this sort has not been     integrated and tested as part of a residential substance abuse program for men. This project     is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education     Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed     by comparing it to PE in the areas of: participant completion rates, hostile cognitions,     emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in     hostile cognitions and emotion regulation will be examined as the mechanisms through which     Fathers for Change reduces relapse, IPV and CM risk behaviors.   "
23407|NCT02979249|"     In the medical literature there are conflicting reports on whether iron improves symptoms in     patients with EPP and XLP. Giving iron to people who are iron deficient is thought to improve     EPP symptoms. However, this has never been systematically tested. Therefore, the purpose of     this study is to determine the effect of oral iron for EPP and XLP patients.   "
23408|NCT02979236|"     The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS     Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST     segment elevation myocardial infarction   "
23409|NCT02979223|"     The aim of this study is to compare the efficacy depending on the order of the sequential     combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic     acid for bowel preparation.      The investigators designed this study as a phase II prospective randomized parallel arm     clinical trial. 67 participant will be enrolled in each group (134 in total).      The primary outcome is the efficacy of bowel preparation. secondary outcomes are     tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.   "
23410|NCT02979210|"     The rationale for the study is to better understand the dynamics of skin microflora following     skin barrier disruption in an adult dermatitis model. The results from this study will     provide insights in the complex interaction between skin microbiome and epidermis under     normal and disease conditions   "
23474|NCT02978378|"     The investigators objective is to assess the utility of renal biomarkers in predicting renal     recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO).     Tissue biomarkers of renal injury may provide a real-time indication of renal function and     the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO.     In these patients, traditional markers of kidney function (urine output and serum Creatinine     level) do not accurately represent renal function.   "
23411|NCT02979197|"     The purpose of this study is to evaluate the effect of celecoxib on the efficacy and safety     of amlodipine on renal and vascular function in subjects with existing hypertension requiring     antihypertensive therapy.      Kitov Pharmaceuticals, Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug     product (FCDP) consisting of the antihypertensive drug amlodipine besylate and the     non-steroidal anti-inflammatory drug (NSAID) celecoxib.      KIT-302 is being developed as a convenience reformulation FCDP to facilitate and improve     patient compliance with the once a day (qd) administration of its individual components,     amlodipine and celecoxib, when used together for the treatment of hypertension, to lower     blood pressure, in patients who also require the use of an NSAID for relief of the signs and     symptoms of osteoarthritis. It is also intended to provide prescribers with detailed data on     how the combination affects the antihypertensive effect of the calcium channel blocker.      The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a     single immediate release tablet. However, for this study, two separate capsules will be     utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo     capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched     placebo tablet.      Kitov recently completed a phase 3 pivotal trial in subjects with newly diagnosed     hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was     statistically non-inferior to amlodipine monotherapy with regard to reduction of blood     pressure. Further, trends towards superior blood pressure lowering effects and improved renal     function were observed for the combination. This study (KIT-302-03-02) is being conducted to     quantify the beneficial renovascular effects noted in the prior study in subjects with     existing hypertension requiring antihypertensive therapy.   "
23412|NCT02979184|"     Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a     decrease in the amount of liquid of the affected limb, with movement of the intracellular     liquid towards the trunk and the neck then into the jugular-subclavian confluence, the     superior vena cava and right atrium without modification of extracellular fluid. No study     have evaluated the prevalence of sleep apnea syndrome in this population and the effect of     this treatment on sleep apnea syndrome.   "
23413|NCT02979171|"     Supraglottic airway tools, one of the tools used in the management of the difficult airway.     American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom     airway management algorithms have included the LMA. In our study investigators aimed to     determine which one will show the best performance with supraglottic airway means that LMA -     Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created     with attaching collar.   "
23414|NCT02979158|"     Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an     increased risk for bleeding.      Present study aims to compare the platelet function in two patient groups using different     types of heart-lung machine methods.      It is assumed that one of the methods is superior verified by sensitive methods of testing     platelet function.   "
23415|NCT02979145|"     The purpose of this study is to develop and validate a clinical outcome measure to evaluate     disability and disease progression of children 3 years of age and younger (infants and     toddlers) with various types of Charcot-Marie-Tooth disease (CMT).   "
23416|NCT02979132|"     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,     are confounded by inflammation from common infections and are therefore of limited use in     populations carrying a high burden of infection and inflammation, as for example women of     reproductive age in malaria endemic areas in developing countries. Even without the     confounding effect of inflammation, current markers of iron status are insensitive to small     changes in dietary iron and do not allow to establish associations between dietary, lifestyle     and genetic factors and iron balance. With a new method based on the dilution of a previously     administered and equilibrated stable isotope signal, an accurate measurement of long-term     oral iron balance and absorption is possible, allowing the estimation of iron requirements     and potentially providing fundamental guidance for supplementation and fortification programs     in both healthy and chronically inflamed/infected patients. In the current study the novel     methodology will be validated in generally healthy subjects with low iron status. The     technique will be used to assess dietary and lifestyle determinants of iron status and to     compare the effect on iron balance and iron status of three distinct, commonly used iron     interventions: food fortification with iron; oral iron supplementation, and intravenous iron     infusion.   "
23417|NCT02979119|"     Rationale:      Haemophilia is a rare disease; to improve knowledge international collaboration is needed.     Well-defined clinical data will be collected from complete cohorts in order to prevent     selection bias.      Objective:      To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous     (treatment-related) determinants of inhibitor development and long term outcome.   "
23418|NCT02979106|"     Background: High fructose intake increases blood lactate, triglyceride and uric acid     concentrations. Uric acid may contribute to insulin resistance and dyslipidemia in the     general population. In patients with hereditary fructose intolerance fructose consumption is     associated with acute hypoglycemia, renal tubular acidosis, and hyperuricemia.      Objective: We investigated whether asymptomatic carriers for hereditary fructose intolerance     (HFI) would have a higher sensitivity to adverse effects of fructose than the general     population.      Design: Eight subjects heterozygous for HFI (hHFI; 4 males, 4 females) and eight controls     received for 7 days a low fructose diet and on the eighth day ingested a test meal calculated     to provide 25% of basal energy requirement containing labeled fructose (13C fructose 0.35     g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). Total fructose oxidation, total endogenous     glucose production (by 6,6-2H2-glucose dilution), carbohydrate and lipid oxidation, lipids,     uric acid, lactate, creatinine, urea and amino acids were monitored for 6 hours.   "
23419|NCT02979093|"     A prior study by the principal investigator of this project identified dopamine- and     oxytocin-related brain pathways that showed a diminished response when addicted mothers     viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These     areas include the hypothalamus, striatum and ventromedial prefrontal cortex. Oxytocin, a     neuropeptide with decreased blood levels seen in addicted mothers, is integrally involved in     maternal brain and behavioral responses. When administered intranasally, the pilot data has     shown enhanced activation of the striatum, prefrontal cortex (PFC) and amygdala.      The purpose of this study is to continue and expand upon the previous investigation of     maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover     study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of     Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction     and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate     in four study visits over a two-month period.   "
23475|NCT02978365|"     Case control study to evaluate different factors (e.g muscle strength, psychological factors)     that are associated with full recovery and functional status 6 months after surgical repair     of shoulder instability.   "
23420|NCT02979080|"     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,     are confounded by inflammation from common infections in sub-Saharan Africa, a region with a     high prevalence of iron deficiency, making the assessment of iron balance and efficiency of     iron intervention difficult. A potential reference method to quantify iron absorption and     requirements using isotope dilution measurements in women living in areas with high burden of     infection should be developed and validated within this project. The new method will allow     accurate measurement of long term oral iron absorption and the estimation of iron     requirements, potentially providing fundamental guidance for supplementation and     fortification programs in sub-Saharan Africa. In a case series with four months' preventative     iron supplementation intervention imbedded between a four months' control period prior     intervention and a four months' control period after intervention, we will follow a group of     63 women. During the intervention period, the women will receive 50 mg Fe as ferrous sulfate     tablets every day for 120 d. In total, the women will give 9 blood samples (day 1, 60 120,     150, 180, 210, 240, 300 and 360) for the de-termination of the isotopic composition and iron     status biomarkers and 5 stool samples (day 1, 120, 180, 240 and 360) for the detection of     soil transmitted helminths and gut inflammation. This design will allow the measurement of     the isotopic iron dilution to assess the total oral iron absorption during the intervention     period in comparison with the control periods without the administration of additional iron     isotopes.   "
23421|NCT02979067|"     Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid     Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.   "
23422|NCT02979054|"     The purpose of this study is to assess the performance and safety of T4020 versus saline     solution.   "
23423|NCT02979041|"     The aim of the proposed study is to investigate the effectiveness of an interactive, virtual     reality (VR) training program for pilots compared with standard care. The study will be a     randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups:     standard physiotherapy and medical care vs standard care and VR training. Outcome measures     will include subjective scores of pain intensity and global perceived effect; objective     measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional     measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and     between groups analyses.   "
23424|NCT02979028|"     This is a single center, randomized, double-blinded, controlled clinical trial. The purpose     of this study is to to determine whether treating by transcutaneous electrical acupoint     stimulation (TEAS) during perioperative could alleviate the postoperative complications in     patients undergoing artificial joint replacement surgery.   "
23425|NCT02979015|"     Primary Objective:      To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese     healthy subjects.      Secondary Objectives:        -  To assess the pharmacokinetic profile of a single SC dose of alirocumab.        -  To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density          lipoprotein cholesterol (LDL-C) and other lipid parameters.        -  To assess the immunogenicity of a single SC dose of alirocumab.   "
23426|NCT02979002|"     The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a     composite reference standard test (Direct examination of skin smears + PCR test) in patients     with clinically suspected Cutaneous Leishmaniasis disease in Morocco.   "
23427|NCT02978989|"     To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is     defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing     consecutive non-solo procedures conducted by a surgeon in the presence or absence of human     assistant(s).   "
23428|NCT02978976|"     The aim of this study is to determine the effect of administering antenatal steroids in term     fetuses on the blood flow in the fetal pulmonary artery, and to correlate these findings with     clinical data obtained after birth documenting respiratory disorders.   "
23429|NCT02978963|"     This case series aims to test the feasibility and acceptability of streamlined cognitive     behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses     on reducing intolerance of uncertainty and the hypothesis is that this will help reduce     worry.   "
23430|NCT02978950|"     This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma     surgery service at Intermountain Medical Center who are deemed to be at high risk for venous     thromboembolism. Once identified and enrolled, subjects will be randomized to receive     bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study     will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and     major and clinically relevant bleeding episode rates, both during the index hospitalization     and at 90 days post-discharge.   "
23431|NCT02978937|"     This is an observational study involving chart review of patients seen in the bariatric     clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into two     groups according to their metabolic profile (healthy vs unhealthy). The assignment to each     group will be determined by the presence of diagnosis of hypertension, diabetes mellitus     and/or dyslipidemia. The presence of at least 2 diagnoses will be defined as metabolically     unhealthy. Then, each group will be divided based on the presence of Obstructive Sleep Apnea     diagnosis. All data will be collected through a review of the patient's electronic medical     record from the bariatric clinic database (the investigators will collect variables as age,     gender, race, BMI, smoking status, the presence of diagnosis as Obstructive sleep apnea,     hypertension, diabetes, hyperlipidemia). The investigators will analyze that data and     establish if there is any correlation between sleep apnea and the subjects' metabolic     profile.   "
23432|NCT02978924|"     To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The     investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore     both motor and sensory pathways of the spinal cord leading to functional improvements.   "
23573|NCT02977091|"     fitness and Physical activity will be evaluate in short stature children, using the Euro     Fitness testing and the Wingate anaerobic test. the fitness level will be evaluate in healthy     short children and with growth hormone deficiency at base line and after 6 month .   "
25810|NCT02948036|"     Specific Aim 1: Finalize development of the closed-loop strategy in the Moodify application.      Specific Aim 2: Evaluate the acceptability and feasibility of the Moodify application with     the target population to prepare for a large-scale efficacy trial.   "
23433|NCT02978911|"     Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves     or vessels closely surround them. Recently, diffusion tensor imaging has developed with the     tractography following white fibers and visualizing functional tracts. Cranial nerves     tractography could allow predicting their displacement by skull base tumors that may help the     surgeon to spare them along the surgery.      Methods: Preoperative cerebral MRI was performed on patients who presented with skull base     tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32     directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128,     b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was     corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically     tracked with Mrtrix3. Cranial nerves were selected according to their location around the     tumor. The radiological expected position of the cranial nerve was compared to its     operative real position.   "
23434|NCT02978898|"     Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its     signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of     lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that     modulates the signaling of several TLRs, but only limited studies have evaluated its     expression by flow cytometry (FCM) in LPD.      Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean     fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained     from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia     (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL,     n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.   "
23435|NCT02978885|"     The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission     computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury.     The investigators will study patients undergoing major surgery, specifically Whipple     procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and     after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.   "
23436|NCT02978872|"     The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole     blood coagulation analysis. This study compares Quantra measurements determined in arterial     versus venous blood samples obtained from patients undergoing cardiac surgery.   "
23437|NCT02978859|"     Primary Objective:        -  To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating          the progression free rate at 12 weeks as compared historical controls.      Secondary Objectives:        -  To further evaluate the safety profile of MGCD516 by assessing adverse event rates          (according to National Cancer Institute CTCAE version 4.0 criteria) in patients treated          with this agent.        -  To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating          the overall response rate (according to RECIST 1.1 criteria), progression free survival          and overall survival in patients treated with this agent.   "
43255|NCT02719496|"     The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day     period, for the treatment of constipation in parkinsonian patients suffering from     gastrointestinal disorders.   "
23438|NCT02978846|"     This study is asking patients who are undergoing radiation therapy with or without     chemotherapy on how well they evaluate their side effects on the last day of treatment. This     study is not to change health outcomes of the patients in this study. Asking patients to rank     side effects in order of which ones bother them the most may help researchers identify the     most troubling side effects of cancer treatment.   "
23439|NCT02978833|"     Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain     Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by     side lying, stair climbing, and walking. Treatment is currently limited to lifestyle     modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical     repair. Platelet rich plasma (PRP) injections contain important growth factors that are     essential in the healing and tissue formation processes. However, the extent to which PRP is     more efficacious than whole blood in tendinopathy remains unclear. In this double-blind     randomized trial, patients will be allocated to receive either a PRP or whole-blood     injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months,     and 1 year.   "
23440|NCT02978820|"     Scoliosis specific exercises have been shown to improve curve progression but there have been     few studies that compare the different exercise approaches in adolescent idiopathic scoliosis     (AIS). The objective of this study was to compare the effects of Core stabilization (CS)     exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to     brace wearing in patients with AIS. It is important to compare different exercise methods on     different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation,     body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.   "
23441|NCT02978807|"     The objective of this study is to determine the most appropriate and effective approach for     the diagnosis of gestational diabetes mellitus (GDM) among pregnant women receiving focused     antenatal care at Moi Teaching and Referral Hospital (MTRH). This will be done through     performing a random blood sugar, fasting blood sugar, 1 hr/2hr glucose tolerance test, and     HbA1c on all participants who meet eligibility criteria and provide written, informed     consent. The specific research question is: what is the most appropriate screening and     diagnostic strategy for patients receiving antenatal care at MTRH?   "
23453|NCT02978651|"     The first objective of this study is to demonstrate the efficacy and safety of pitolisant     given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,     to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea     (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by     nCPAP but still complaining of EDS.      The secondary objectives of the study include assessing the long-term tolerance as well as     the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of     Open Label Extension period.   "
23574|NCT02977078|"     This study will use inhaler technology to observe and feedback overall patterns of medication     use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler     overuse.      We will also assess whether inhaler technology is patient-friendly and cost effective,     whether it helps with treatment decisions in asthma and whether it can help us to predict and     prevent asthma attacks.   "
23442|NCT02978794|"     With the extension of the average life expectancy, the incidence of cardiovascular diseases     is also rising. Stroke in Taiwan has been the leading cause of morbidity and mortality, but     also in countries around the world), stroke and the impact of socio-economic and health     spending are large how to reduce the degree of disability after stroke is an important issue     in medicine. For a long time, the resident will fill the clinical pathway form before the     stroke inpatients were discharged. We also analyzed the data of clinical pathway every three     months.      According to the current data of stroke clinical pathway included demographic data, length of     hospitalization days, complications, functional independent measure, Brunnstrom motor     recovery stage, mini-mental state examination, geriatric depression scale, blood pressure     data, and post-stroke checklist for a retrospective analysis to provide more complete and     more comprehensive information on follow-up care for stroke patients and effective use of     medical resources, to improve the quality of future medical care and quality of life for     stroke patients.   "
23443|NCT02978781|"     This study is a two-part, multicenter, Phase 2a study to evaluate the efficacy, safety,     tolerability, and pharmacokinetics of SAGE-217 in approximately 60 adult subjects with     essential tremor.   "
23444|NCT02978768|"     The objective of the present project is to develop complementary and alternative medicine     (CAM) for The Chang Gung Dementia Center to alleviate the symptoms and signs of patients with     Alzheimer Disease, an approach aiming at decreasing the burden on family, society and nation.   "
23445|NCT02978755|"     First in human study, assessing the safety profile, the pharmacokinetics and preliminary     antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with     previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor     II) receptor. The primary objective of the study is to determine the GM102 recommended dose.   "
23446|NCT02978742|"     Bulimia nervosa and binge eating disorder pose a public health concern due to their high     co-occurrence with other psychiatric disorders and poor physical health outcomes. It is     therefore concerning that less than half of these patients seek treatment for their     condition. People may be reluctant to seek treatment due to not wanting to disclose symptoms     to family members. Even for those who do wish to seek help, treatment is often inaccessible     due to the geographic centralization of eating disorder specialists and a low ratio of     specialists to patients. Therefore, the aim of this study is to test a potential solution to     these problems and make eating disorder care more private and accessible.      One possible way to improve the accessibility of treatment is through smartphone applications     (or apps). We are testing an app called Recovery Record, which is primarily a tool used to     self-monitor eating habits, where patients record their meals and related thoughts, feelings,     emotions, and behaviours (e.g., binge eating/purging). The app also offers additional     features such as discrete reminders to log meals, positive reinforcement, social support,     coping strategy suggestions, and linking users with clinicians for real-time feedback and     suggestions. The application is scientifically supported and has been tested with positive     results.      Recently, app developers have created a computer-automated 8-week treatment program that uses     the patient's data to provide a tailored and individualized treatment program. This program     aims to mimic the process of therapy by checking in with users, reminding them of their     reasons for wanting to recover, and working towards goals. We will be testing this automated     app treatment program, comparing it both with and without input from a trained coach     providing individualized feedback to users.   "
23447|NCT02978729|"     The purpose of this study is to compare two methods for remote genetic counseling (telephone     and two-way videoconferencing) for patients who are receiving disclosure of their APOE     (apolipoprotein E) genotype. The target population will consist of males and females in the     age range of 60-75 years who, as potential participants in a study (Generation Study), will     need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing     to receive genetic counseling and disclosure remotely. Subjects must be willing to be     randomized to either telephone arm or videoconference arm.   "
23448|NCT02978716|"     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor     efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients     with metastatic triple negative breast cancer.      The study is open-label and approximately 90 patients will be randomly assigned (1:1:1     fashion) to 1 of the 3 following treatment groups:        -  Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30)        -  Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day          cycles (n=30)        -  Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of          21-day cycles (n=30)      The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival     Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and     completes at the Post-Treatment Visit.   "
23449|NCT02978703|"     Observational study for the evaluation of clinical effectiveness in daily clinical practice     of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg -     Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive     Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history     of repeated exacerbations and who have significant symptoms despite regular bronchodilator     therapy in Greece.   "
23450|NCT02978690|"     This is a phase I, open label, single group study that is being performed to assess the     safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single     dose of BI 655130 in adult patients with active Generalized Pustular Psoriasis (GPP).   "
23451|NCT02978677|"     The trial evaluates the effect of a moderately increased radiation dose in patients with     atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery.     Endpoint is recurrence-free survival after 5 years.   "
23452|NCT02978664|"     The investigators will review video-recordings of three randomized, controlled trials     (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water     exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi     Hospital.   "
23575|NCT02977065|"     A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess     the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor     CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.   "
23454|NCT02978638|"     This study aims to improve continence of patients with spinal cord injury using electrical     stimulation.      The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving     bladder and bowel function in patients with spinal cord injury (SCI). It has been     commercially available in Britain and other countries since 1982, and has been used in     thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA     approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing     urination on demand and to aid in bowel evacuation.      Electrical stimulation to produce bladder contraction and improve bladder voiding after     spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex     contraction of the bladder, which improves continence. However, cutting these nerves has     undesirable side effects. This study will not cut any sensory nerve. This study is testing     the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to     improve continence after spinal cord injury.   "
23455|NCT02978625|"     This phase II trial studies how well talimogene laherparepvec works and nivolumab in treating     patients with lymphomas that do not responded to treatment or non-melanoma skin cancers that     have spread to other places in the body or do not responded to treatment. Biological     therapies, such as talimogene laherparepvec, use substances made from living organisms that     may stimulate or suppress the immune system in different ways and stop tumor cells from     growing. Monoclonal antibodies, such as nivolumab, may block a protein needed by tumor cells     to grow and spread. Giving talimogene laherparepvec and nivolumab may work better in treating     patients with lymphomas or non-melanoma skin cancers.   "
23456|NCT02978612|"     This is a phase 2, randomized study where the aim of the study is to investigate the     tolerance of adjuvant chemotherapy, measured by functional decline, after surgery for colon     cancer stage III in elderly patients. Secondary aims are disease-free survival, toxicity,     late functional outcome, quality of life, to establish a geriatric assessment for selection     of patients, and to examine the prognostic value of gene signature tests / biomarkers for     stage III colon cancer.   "
23457|NCT02978599|"     Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase,     cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of     AVL-3288 each compared to placebo, in patients with schizophrenia.   "
23458|NCT02978586|"     The purpose of this study is to see if positron emission tomography/ magnetic resonance     imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an     investigational radioactive drug called [Ga-68]PSMA.   "
23459|NCT02978573|"     Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant     established by the pivotal trial.   "
23460|NCT02978560|"     The aim of this project is to demonstrate that fluorescence-mediated photoplethysmography     (FM-PPG) is capable of routinely acquiring the tissue perfusion data sufficient to detect and     monitor skin tissue perfusion anomalies.   "
23468|NCT02978456|"     The purpose of this study is to compare clinical outcomes between quantitative coronary     angiography -guided and Intravascular ultrasound -guided strategy in patients with     significant coronary artery disease undergoing sirolimus-eluting Orsiro stent implantation.   "
23483|NCT02978261|"     This phase I, open-label, dose-escalation study was conducted to determine the maximum     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),     pharmacokinetics (PK) profile, and preliminary antitumor activity of single and multiple     doses of PLB1001 in Patients with PTPRZ1-MET fusion gene positive recurrent high-grade     Gliomas.   "
23461|NCT02978547|"     This is a single arm, non-randomized phase II study of neoadjuvant metformin in resectable     PDAC. Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of     7 days, until 2 days prior to surgery. Patients will undergo laboratory investigations at     baseline, prior to surgery and 4-10 weeks after surgery. Patients eligible for and consented     to the optional MRI substudy will undergo diffusion-weighted MRI 1 to 14 days before surgery.      At surgery, resected tumour and normal tissue will be collected and banked. FFPE specimens     will be used for sectioning, histological analysis and IHC for Ki67 (cell proliferation     marker), pAMPK, ACC targets, p53 and mTOR targets, apoptotic markers (Bax, Bcl-2, caspases 3,     8 and 9). Fresh frozen tumour and matched normal tissue samples will be used for western blot     analysis of insulin and IGF receptors, total and activated ERK and Akt, and RNAseq analysis.     Pre-metformin biopsy samples will be retrieved for molecular analysis.      Fasting blood samples at baseline and before surgery will be analyzed for glucose and insulin     levels. Plasma and whole blood will also be processed and banked for circulating tumour DNA     analysis. Urine samples will be sent for metabolomic profiling.   "
23462|NCT02978534|"     The widespread and common use of quetiapine in childbearing and pregnant women demands more     data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling     Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C,     D, and X categories. Additionally, the PLLR will require information to aid prescribing     decisions in three categories 1) Pregnancy (including labor and delivery), 2) Lactation, and     3) Females and Males of Reproductive Potential. The pregnancy category will include a     subsection that will describe pharmacokinetic and pharmacodynamic characteristics of the     medication in pregnancy, fetal risk, and data quality. The data collected in this study will     update the FDA pregnancy pharmacokinetic section for quetiapine and inform physicians that     prescribe to childbearing women.   "
23463|NCT02978521|"     Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading     cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC     affecting up to 80% of patients with advanced stage disease, and it has been related with     higher risk of complications, length of hospital stay, and worst overall survival. During     cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has     been associated to higher treatment related toxicity, loss of functional status, shorter     progression free survival and overall survival in different types of cancer under various     treatments. Hence, preservation of muscle mass and function should be an important focus of     the multidisciplinary treatment of patients with LC.      Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue     and improve exercise tolerance in patients with LC undergoing curative surgery. However, few     studies have focused on the efficacy of PR on patients with advanced cancer undergoing     palliative care with chemotherapy or targeted therapies.   "
23464|NCT02978508|"     This is a multi-center, double-blind, randomized, two arm parallel design study. This study     is comprised of two phases: screening and treatment. The screening period will be up to 5     days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will     be randomized to receive either test or reference treatments in a double-blind manner in an     outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and     reference drug arms and will be stratified by site.      Screening will begin at visit 1, during which eligibility will be determined and prohibited     treatments will be discontinued. Randomization will occur following the confirmation of the     eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The     treatment phase will be 28±4 days in duration wherein subject will receive treatment with     investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and     tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and     tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day     28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the     subject will be retreated with the second application of the investigational product.   "
23465|NCT02978495|"     Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15%     of all cases diagnosed correspond to the triple negative subtype. Triple negative breast     cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of     target therapies to date, there is no consensus regarding the most effective treatment for     this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly     sensitive to chemotherapy when compared to other breast tumors, there is no evidence to     support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1     / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a     prospective, randomized, open-label, phase II study, evaluating the rate of complete     pathologic response, disease-free survival, overall survival and prognostic evaluation of     BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential     neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.   "
23466|NCT02978482|"     A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability,     Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in combination with     tremelimumab in Chinese Patients with Advanced Malignancies   "
23467|NCT02978469|"     Long hours of daily sitting and lack of Physical Activity (PA) are risk factors for morbidity     and mortality.      People with movement disabilities, including adolescents with Cerebral Palsy (CP) tend to     lead a sedentary life styl and have have poor physical fitness. Adolescents with CP where     found to be inactive most of the day thus, they are in greater risk of disease than the     general population. In addition, over the years, people with disabilities experience physical     and functional deterioration. Reducing sedentary behavior and increasing daily activity can     reduce health risk factors among the adolescents with CP, reduce secondary impairments and     preserve function.      Interventions that included exercise alone has not resulted in physical activity and     participating in a structured training did not continue after cessation intervention.      The objectives of this study are to establish effective programs aiming to promote an active     life style among adolescents and young adults with CP and to evaluate there outcomes.      Specific objectives- Stage 1- Identifying barriers and facilitators for reducing sedentary     behaviors and increasing physical activity among adolescents and young adults with CP. As     well as, identifying mediators, needs and preferences for reducing sedentary behaviors and     increasing physical activity among adolescents and young adults with CP.      Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and     increasing physical activity among adolescents.      Stage 3- translating and developing questioners for the study.        -  Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and          validating the Hebrew translation.        -  Developing a self-efficacy perception questioner for increasing physical activity and          reducing and sedentary behavior.        -  Translating to Hebrew, adjusting and validating an activity diary.      Stage 4- evaluating the effectiveness of the proposed intervention program on reducing     sedentary behaviors and increasing physical activity among adolescents and young adults with     CP.   "
44975|NCT02696967|"     The purpose of this study is to determine the safety and tolerability of CLR325 in heart     failure patients to determine if further clinical development of the drug in this indication     is warranted.   "
23469|NCT02978443|"     Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous     melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab     followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for     histopathology review and immunohistochemistry analysis at Georgetown University-Lombardi     Comprehensive Cancer Center. Pretreatment blood will be drawn and stored in the Melanoma     Research Foundation Breakthrough Consortium Virtual Repository at each participating     institution. At the end of participation, samples will be sent to Georgetown     University-Lombardi Comprehensive Cancer Center for processing and storage. An optional     pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled     patients. Patients will receive nivolumab in combination with ipilimumab according to the     standard FDA approved treatment regimen.   "
23470|NCT02978430|"     The aim of this study is to compare the implementation of computer-assisted goal directed     fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.   "
23471|NCT02978417|"     In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness     in drug courts, investigators propose a feasibility study in the Wake County, North Carolina     drug court, where an estimated 50% of clients are opioid dependent.      Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and     eligible clients of the Wake County Drug Court.   "
23472|NCT02978404|"     Stereotactic radiosurgery (SRS) is increasingly administered as the sole treatment of brain     metastases, in order to spare acute and long term side effects associated with whole brain     radiotherapy. Local control of SRS treated lesions is good, but patients tend to develop     additional brain metastases subsequently.      Nivolumab is a modulator of the immune system. Treatment with Nivolumab is associated with an     increase in local control and survival in patients with non-small cell lung cancer and clear     cell renal cell carcinoma. In the presence of Nivolumab, treatment of brain metastases with     SRS may trigger an immune reaction against cancer. Therefore, the combination of SRS with     Nivolumab may reduce the development of new brain metastases and improve patient survival.      The purpose of this study is to assess the effect of combining Nivolumab and SRS in     controlling cancer progression. SRS will be administered to patients while they are receiving     Nivolumab.   "
23473|NCT02978391|"     UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic     treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.      Several endoscopic hemostasis methods are currently in use. UI-EWD (Endoscopic Wound     Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect     and safety in endoscopic application will be verified. This study has been designed to     observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic     hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.   "
23476|NCT02978352|"     Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced     attention, impaired cognition and perception, usually resulting from general physical     conditions. Delirium contributes to longer hospital length of stay, increased mortality,     increased healthcare costs, and long-term cognitive and functional impairment. However, it is     often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a     time-efficient, flexible and convenient training method, making it suitable for a large     organization like Siriraj hospital where there is a large employee turnover rate. So the     investigators want to compare the passing rate between the e-learning group and the     traditional learning group.   "
23477|NCT02978339|"     The purpose of this study is to determine whether curcumin, a drug and naturally-occurring     plant compound, is safe and effective in the treatment of primary sclerosing cholangitis     (PSC).   "
23478|NCT02978326|"     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of     the efficacy, safety and pharmacokinetics of SAGE-217 in up to 32 adult female subjects     diagnosed with severe postpartum depression.   "
23479|NCT02978313|"     Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction     treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive     metastatic colorectal cancer after first line induction treatment for 24 weeks with     mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of     progression.   "
23480|NCT02978300|"     Acute respiratory failure is the leading cause of ICU admission of immunocompromized     patients. In this subgroup of patients, the need for intubation and invasive mechanical     ventilation occurs in about 50% of cases and is associated with very a high mortality rate,     reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to     avoid intubation.      More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and     mortality rates of immunocompromized patients as compared to standard oxygen through a mask.     However these results have not been confirmed in a recent large trial.      HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone     could decrease mortality and intubation rates in patients with ARF as compared to NIV.     Similar findings have been reported in a post-hoc analysis on immunocompromized patients     excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of     immunocompromized patients, we reported better outcomes with HFNC than with NIV.   "
23481|NCT02978287|"     The aim of this study is to measure of the parathyroid cell viability and the the amount of     calcium sensing receptor of the parathyroid cells which were placed into a new transportation     solution (BAVU solution) for parathyroid allotransplantation.   "
23482|NCT02978274|"     Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK     cells phenotype and functional reconstitution.   "
23484|NCT02978248|"     ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.      The study design includes three study arms:        1. ARENA Intervention: This project will examine the effectiveness of population education.        2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether          there are any complications.        3. ARENA Migration: ARENA migration aims to examine whether a targeted population education          can improve the care of people with a Turkish migration background.   "
23485|NCT02978235|"     The Phase 1 portion of this study will determine the safety of TAS4464 and the most     appropriate dose for patients with Multiple Myeloma or Lymphoma. The Phase 2 portion of the     study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma     or Lymphoma   "
23486|NCT02978222|"     This is a double-blind, randomized, parallel groups Phase II trial. Patients with     platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1     criteria following completion of standard-of-care chemotherapy, including a minimum of 4     cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine     regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be     administered as a consolidation therapy within one year of the last administration of     platinum, targeting the first remission.   "
23487|NCT02978209|"     A randomized double blinded clinical trial will be conducted comparing the effect of three     simple basic moisturizers only different in the concentration of carbamide (urea). Three     concentrations of carbamide will be tested, 5, 7.5, and 10 %, respectively. The study will be     conducted as a split-body-study and will contain three arms randomized to comparing 5 and 7.5     %, 5 and 10 %, and 7.5 and 10 % carbamide, respectively. 20-30 patients with at least     clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the     moisturizers will be assessed by clinical examination (score), patients assesment of effect     and measurement of transepidermal water loss (TEWL) and other skin parameters.   "
23488|NCT02978196|"     To evaluate the efficacy and safety of 99m-Tc labeled anti-PD-L1 VHH for SPECT/CT diagnostic     imaging of Non-Small Cell Lung Cancer and compare it with the existing gold standard biopsy     PD-L1 detection. It is also to establish a new method of clinical diagnosis of NSCLC using     99m-Tc labeled anti-PD-L1 VHH.   "
23489|NCT02978183|"     The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to     placebo for the treatment of the signs and symptoms of allergic conjunctivitis.   "
23490|NCT02978170|"     The goal of this clinical research study is to find out if adding a Cone-Beam CT (CBCT) scan     during a scheduled bronchoscopy can help researchers biopsy lung lesions that are harder to     reach.      CBCT is a newer type of CT scan that researchers will use to make sure the tools used to     biopsy these lesions (called a bronchoscope and a radial probe-EBUS [RP-EBUS]) are in the     right location. The safety and feasibility of adding this extra scan to a standard     bronchoscopy will also be studied.   "
23491|NCT02978157|"     From the profiles of antibiotic susceptibility data following eradication therapy,     tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the     rescue treatment.   "
23492|NCT02978144|"     This will be a prospective study examining the use of 99mTc-Annexin V-128 (AxV-128/Tc)     single-photon emission computed tomography (SPECT)/computerized tomography (CT) technology in     the imaging and functional assessment of the lung of patients with chronic obstructive     pulmonary disease (COPD), healthy volunteer smokers without COPD and healthy volunteer     subjects without smoking history. The aim of study is to determine if patients with COPD have     an increased AxV-128/Tc signal with SPECT/CT.   "
23493|NCT02978131|"     Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world     population is infected with Mycobacterium tuberculosis. There is an increase in the number of     cases of classic tuberculosis in developing countries, even if number of cases are declining     in developed countries. However, in developed countries this decrease is counterbalanced by     the emergence of multidrug resistant (MDR) strains of the bacteria.      There are also latent forms (1/3 of the world population) of the infection that can be     reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis and     9 million new cases are identified, including about 500,000 cases of MDR TB.      The spread of this disease as well as the increasing number of cases of MDR tuberculosis,     reinforce the need for research and development of strategies of diagnosis and management of     this affection.      Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at     least three weeks to be performed. The objective of this study is to evaluate the sensitivity     and specificity of histopathological and molecular techniques (PCR) on paraformaldehyde fixed     and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice,     in order to administrate an efficient treatment as soon as possible.   "
23494|NCT02978118|"     This pilot study purpose of this study is to describe peripheral circulating immune cell     profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell     carcinoma and urothelial carcinoma.   "
23495|NCT02978105|"     The investigators hypothesized that hypnosis is an alternative technique that could be     applied to help patients with obesity to lose weight.      The possibility that a self-conditioning technique (self-hypnosis) added to traditional     approach (diet, exercise and behavioral recommendations) will be effective in determining     weight loss with respect to the traditional approach in subjects with a body mass index (BMI)     between 35 and 50 kg/m2 will be studied.   "
23496|NCT02978092|"     Retrospective, analysis of three different methods to measure patients' pupil diameters   "
23497|NCT02978079|"     Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye     and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the     sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of     the etiologies for ischemic stroke in young patients.      In our current study, we will explore the diagnostic accuracy of automated binocular     pupillometry in the diagnosis or HS, and its potential in identifying dissection of the     carotid artery in patients of young age who suffer ischemic stroke.   "
23562|NCT02977234|"     The purpose of this study is to assess the effectiveness of hysteroscopic tubal application     of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx,     which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.   "
23498|NCT02978066|"     Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac     Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was     defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations     between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal     anesthesia were analysed by logistic regression analyses.   "
23499|NCT02978053|"     This project examines 1) the effects of appropriately timed bright light on adaptation (in     terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such     bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule     after the night shift period.   "
23500|NCT02978040|"     Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients     with ST-elevation myocardial infarction (STEMI). The optimal platelet inhibition at the time     of PCI is fundamental, however, the comparative speed of action of cangrelor as opposed to     tirofiban and to chewed or integer loading dose of prasugrel is unknown.      The purpose of this trial is to assess the inhibition of platelet aggregation with different     regimens on platelet inhibition (tirofiban bolus+infusion, cangrelor bolus+infusion,     prasugrel chewed loading dose, prasugrel integer loading dose) in the early phase of primary     PCI.   "
23501|NCT02978027|"     The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels.     More than 50% of alcohol health consequences occur in risky, non-dependent drinkers.     Increasing the efficacy and efficiency of brief interventions in medical setting could     significantly reduce the public health impacts of risky drinking. There is intense interest     in conducting motivational interviewing (MI) informed brief interventions for risky alcohol     use in medical settings, but little empirical information is available regarding which MI     behavioral and interpersonal style components drive effectiveness. The field would benefit     greatly from empirically-based Stage 1 treatment development and modeling studies to     delineate the degree to which adding motivational interviewing components to brief     intervention improves outcome.   "
23502|NCT02978014|"     A two-arm randomised controlled trial in patients receiving post-prostatectomy radiotherapy     in the adjuvant or salvage setting, with patients randomised to receive daily ProSpare     (obturator) guided IMRT or Centre standard (non-obturator) guided IMRT.   "
23503|NCT02978001|"     The pathophysiological mechanisms explaining the association between psoriasis and type 2     diabetes are largely unknown but it has been hypothesized that systemic inflammation found in     both psoriasis and type 2 diabetes might play a role. In a recent study hyperinsulinaemic     euglycaemic clamps were performed and it showed that normal glucose-tolerant patients with     moderate to severe psoriasis had lower whole-body insulin sensitivity during insulin     stimulation compared to healthy matched controls. Thus, the increased risk of type 2 diabetes     in patients with psoriasis appears to include defects in the glucose metabolism linked to     psoriasis itself. However, the methods applied did not allow a detailed characterization of     the metabolism in patients with psoriasis. Tracer technique combined with indirect     calorimetry has never been applied to study hepatic and whole body insulin sensitivity, and     glucose and fat oxidation, during basal conditions or during insulin stimulation in patients     with psoriasis.      Aim of study:      The aim of this study is to investigate hepatic and whole body insulin sensitivity and     glucose and fat oxidation during both basal and insulin-stimulated conditions in patients     with psoriasis.   "
24042|NCT02970968|"     This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in     the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy     the selection criteria for the study, will be randomized to one of two treatment groups,     active or placebo.   "
23504|NCT02977988|"     Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of     alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related     to crime, lost work productivity and health care. While effective treatments exist, over half     of those who enter treatment for substance use disorders drop out early in treatment and     return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis     of substance use disorder (SUD) and relapse risk. Low-income women report high levels of     stress in SUD residential treatment stemming from significant economic and family stressors     in addition to challenges of adjusting to residential treatment demands. Unmanaged stress,     especially in early stages of residential treatment, is a major concern because it can     increase dropout. Dropout from residential treatment places women at risk of substance use     relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions     with racially/ethnically diverse low-income women with SUDs, especially regarding the     efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout     and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI,     Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women     (MBRP-W), that supports the needs of women in residential treatment. This MBI integrates     relapse prevention, addresses literacy level, and is relevant to issues surrounding     treatment- and relapse-related stressors of disadvantaged women. The current project has     three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention     and substance use relapse in racially/ethnically diverse low-income women; (2) to determine     the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes     associated with program effects. A rationale for MBRP-W is the need for self-initiated stress     management skills in women with SUDs during the early stressful periods of residential     treatment that increase risk of dropout and relapse.   "
23505|NCT02977975|"     The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut     in the treatment of irritable bowel syndrome.   "
23506|NCT02977962|"     Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young     adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety     disorders affect many higher-functioning adolescents and young adults with ASD, causing     substantial distress and impairment over and above that caused by an ASD diagnosis alone.     While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders     among typically developing late adolescents, and work by the investigative team supports its     utility in children with ASD and comorbid anxiety, very few evidence-based treatment     approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the     investigators are proposing to develop a CBT protocol for clinical anxiety that is     personalized to the unique clinical characteristics of late adolescents (ages 16-21 years)     with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA).   "
23507|NCT02977949|"     There are few reports concerning to the seasonal variation of osteoporosis treatment. In this     study, we plan to compare clinical efficacy and safety by seasons.   "
23508|NCT02977936|"     The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts     of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for     patients suffering from gonarthritic pain.   "
23704|NCT02975388|"     This is a multi-center, non-randomized, open-label, two-part study to investigate the effect     of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male     and female participants with stable mild, moderate or severe renal impairment and a control     group of participants with normal renal function. Part 2 will be conducted in adult male and     female participants with stable end-stage renal disease undergoing hemodialysis.   "
23509|NCT02977923|"     Children with burn injuries experience severe pain intensity during medical procedures     despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain     management recommend the combination of non-pharmacological and pharmacological interventions     to enhance pain management and decrease the numerous side effects of analgesics. Virtual     reality (VR) has gained growing consideration as a non-pharmacological method as it engages     multiple senses and allows interactions with a virtual world. Oculus Rift ® (OR) is a new     technology in VR that provides more immersiveness, at a relatively low cost, and could     probably improve the management of pain and anxiety in burn care. It also has the potential,     with appropriate custom software designed for burn pediatric patients, to reduce the     cybersickness symptoms (nausea, dizziness) associated with VR. Overall hypothesis:     Distraction by VR via the OR, in combination with the standard pharmacological treatment, is     a feasible, acceptable and satisfactory method for the management of pain and anxiety during     burn-related treatments in children with burn injuries.      Note that this pilot study will precede a larger trial aimed at assessing the effect of     virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)   "
23510|NCT02977910|"     Ankle fracture is very common which is often combined with deltoid ligament injury. Although     the incidence of deltoid ligament injury is high, but there is no unified and effective     diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs     surgical repair is still controversial. There is no high-level, multi-center, large sample,     long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is     necessary or not. The main content of the project: 1 Achieve accurate classification of     deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications     and treatment guidelines by comparative study.   "
23511|NCT02977897|"     Prospective, observational pilot study of ten post-transplant patients presenting with     diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard     workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to     determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once     the diagnosis is confirmed, the patients will then be treated with a short course of     subcutaneous Octreotide which has been shown to cure this type of diarrhea.   "
23512|NCT02977884|"     The project proposes to provide the Complete Health Improvement Program (CHIP) initially up     to 25 adult (non-pregnant) Ohio University employees (and/ or their adult family members)     with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension,     atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve     self-management and the consequences of biometric factors that can be modified by lifestyle     changes. The CHIP program is an educationally based, lifestyle intervention program that aims     to reduce healthcare cost, absenteeism, and increase employee productivity. The investigators     expect that participants following the programs guidelines will lower their body mass index,     cholesterol, reduce blood pressure and blood glucose levels, and therefore help to prevent     chronic disease.   "
23817|NCT02973919|"     The goal of this study is to increase the efficiency of exposure in virtual reality (VR).      Based on the EMDR research the investigators would like to show that the implementation of     eye movements during the VR exposure results in a faster physiological relaxation response     among probands with spider phobia, which has a positive effect on the subjective and     behavioral efficacy of the VR exposure.   "
23513|NCT02977871|"     Cesarean section is the most common surgical procedure performed on women. Over the years     minor variations of each surgical step have been introduced, and cesarean sections are not     standardized and many different techniques are employed during surgery. Creation of a bladder     flap has been an integral surgical step of the cesarean section for many years. The role of     the bladder flap and its usefulness in cesarean section is not known well. Further, in some     cases the bladder flap is omitted during cesarean section. The aim of the current study is to     compare operating time and postoperative urinary symptoms in cesarean sections using either     bladder flap or omission of flap.   "
23514|NCT02977858|"     This study is a single site prospective controlled trial assessing two educational     interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses on     collaboratively developed treatment guidelines for pediatric constipation. The study aims to     assess the impact of an Spaced Education game to aid the implementation of the management     guideline. PCP adherence to recommended treatment will be assessed in addition to PCP     satisfaction with the educational methods, constipation knowledge and patient outcomes.   "
23515|NCT02977845|"     Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung     cancer patients: A randomized control trial   "
23516|NCT02977832|"     Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action     on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume,     improving the patient's quality of life and eventually limiting the number of patients who     require surgery or endoscopy after medical treatment.   "
23517|NCT02977819|"     As the number of older people in Europe grows, increasing healthy life years is a priority.     As people live longer, ensuring good mental as well as physical health into later years is     becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD),     sleep disturbances and depression, all related to psychological distress and anxiety, are     significant drivers of reduced quality of life in older adults. This project builds on     evidence that meditation practice have the potential to downregulate these adverse factors     and positively impact mental and neurological conditions including AD.   "
23518|NCT02977806|"     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,     are confounded by inflammation from common infections in sub-Saharan Africa, a region with a     high prevalence of iron deficiency, making the assessment of iron balance and efficiency of     iron intervention difficult. A new method allowing accurate measurement of long-term oral     iron absorption and allowing the estimation of iron requirements is highly needed. Such a     novel method to quantify iron absorption and requirements using isotope dilution measurements     in children should be validated in the present prospective observational study by     following-up a group of 49 children given a stable iron isotope in an earlier trial. We will     request seven blood samples within 2 years (sampling every four months) from the participants     which will allow us to measure isotopic dilution for estimating total oral iron absorption     over these 24 months.   "
23519|NCT02977793|"     The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.   "
23520|NCT02977780|"     This research study is studying several investigational drugs as a possible treatment for     Glioblastoma (GBM).      The drugs involved in this study are :        -  Abemaciclib        -  Temozolomide (temodar)        -  Neratinib        -  CC115   "
23522|NCT02977754|"     The principal objective of this study is to explore the role of 18F-FDG PET in identifying     sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease     outcome in advanced HCC patients candidate to systemic treatment with sorafenib.   "
23523|NCT02977741|"     Prospective, observational study evaluating the effect of olanzapine for the treatment of     refractory chronic nausea and vomiting.   "
23524|NCT02977728|"     In this project the investigators aim to evaluate olfactory and non-olfactory function in     patients within the first 24h following a mild traumatic brain injury (acute mTBI) and     compare their results to a group of age and sex matched control patients suffering from an     orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year     after the trauma   "
23525|NCT02977715|"     Monkeypox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in     the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus     infections that can prevent them from performing work duties, compromise the overall     healthcare delivery in an already fragile system, and can result in death (case fatality     estimates are approximately 10%).      This is an open-label prospective cohort study in up to 1,000 eligible healthcare workers at     risk of monkeypox infection through their daily work. The study will document monkeypox     exposure and infection in participants while concurrently evaluating the immunogenicity and     safety of the vaccine, IMVAMUNE, in healthcare personnel in the DRC. Participation in the     study is voluntary and open to male and female healthcare personnel ages 18 years and older     in Tshuapa Province in The Democratic Republic of Congo who are at risk of monkeypox virus     infection through their daily work or laboratory personnel performing diagnostic testing for     monkeypox virus.   "
23526|NCT02977702|"     The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an     independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma.     Secondary objective was to describe the evolution of the TPA during the follow-up.   "
23527|NCT02977689|"     The purpose of this study is to found out if the drug IDH305 is safe and effective in     subjects with IDH1 mutant grade II or III glioma that has progressed after observation or     radiation therapy.   "
23528|NCT02977676|"     The aim of this study is to determine the prevalence of ventilator-associated events (VAE).     To analyze the patients profile, morbidity and mortality compared to patients who did not     develope VAE. The preventability of VAE will be assessed by comparing the percentage of     adherence to the bundle of preventive measures among patients who developed and did not     develope VAE.   "
23658|NCT02975986|"     We will test the hypothesis that renal uptake of free (i.e. non-esterified) fatty acids (FFa)     is increased in iuan. To accomplish this goal we will measure renal FFa uptake FFa uptake in     vivo in patients with iuan and matched non-stone forming subjects via single-photon emission     computed tomography (SPeCT)/CT imaging.      The definitive proof of our hypothesis rests on whether increased renal FFa uptake is     demonstrable in humans with iuan.   "
23529|NCT02977663|"     1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and          molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic          Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor          Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and          follow-up informations (Response to first-line treatment (Response Evaluation Criteria          in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).        2. To propose a simple severity scoring system based on tumor features such as size,          doubling time (if available), location, amount of enhancement and necrosis. Such          approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images          (VASARI)) but is not available for the lung. The objective is to do better than the          Tumor Node Metastasis (TNM) staging.        3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer          evaluation.   "
23530|NCT02977650|"     To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin     bridge.   "
23531|NCT02977637|"     Magnetic resonance (MR) imaging is performed with contrast agents to highlight the blood     vessels and allow interpretation and diagnosis of blood vessel abnormalities. HHT (Hereditary     Hemorrhagic Telangiectasia) is a disease of blood vessels, and can suffer fatal bleeding if     abnormal blood vessels are not detected and treated early. Patients with HHT also require     many imaging studies through their lifetimes for surveillance of blood vessels. Many HHT     patients also have co-existing iron deficiency anemia from bleeding in their nose and     gastrointestinal tract, and receive daily iron therapy.      Ferumoxytol is an alternative MR contrast agent, which is FDA (Food and Drug Administration)     approved for the treatment of iron deficiency anemia. In addition, it is not associated with     the risks to the kidneys of the other agents. The use of ferumoxytol for MR imaging may     benefit the patients who do not currently receive imaging due to the contraindications of the     conventional contrast agents. It avoids the use of ionizing radiation. Also, the conventional     contrast agents are associated with risks. Iodinated contrast in CT is associated with     significant risks of kidney damage. Another imaging technique, MR, uses gadolinium based     contrast agents. Gadolinium, if used in patients with pre existing kidney dysfunction     (defined as GFR < 30ml/min) is associated with the development of another devastating disease     called nephrogenic systemic fibrosis. As HHT patients will require repeated scans throughout     their lifetimes, this study will provide them a safer alternative.      Ten patients from the HHT clinic in whom the use of ferumoxytol as an MR agent is clinically     indicated will be invited to participate in this study, which will determine if MR with     ferumoxytol is able to detect and characterize vascular malformations in HHT.   "
23532|NCT02977624|"     Objectives - To evaluate the effectiveness of an intervention program based on     tele-rehabilitation in stroke survivors. The aim of the intervention is to improve the     transition from rehabilitation units to community dwelling and facilitate involvement in life     roles in the community.      Working hypothesis - The tele-rehabilitation based program for stroke survivors will be     effective in:        1. Improving function in activities of daily living, participation in occupations and          health related quality of life.        2. Reducing the need for outpatient clinic and rehabilitation services.        3. The intervention achievements will be maintained in 6 months follow-up      Methodology - Participants: Stroke survivors will be selected from patients who are referred     to the outpatient or home-based rehabilitation unit of Maccabi health services. The     participants will be randomly assigned into two groups: The treatment group (N=30) will     receive the intervention program in addition to standard care, and control group- standard     care only.      Outcome measures:        1. Mayo-Portland Adaptability Inventory (MPAI-4)        2. Stroke impact Scale (SIS)        3. The Canadian Occupational Performance Measure (COPM)        4. A 12-Item Short-Form Health Survey (SF-12)        5. The Zarit Caregiver Burden Scale short version      Procedure: The intervention program includes 20 video chat sessions over 10 weeks between an     occupational therapist and the participant, in the presence of the primary care giver. The     virtual meetings will be conducted using The Cognitive Orientation to daily Occupational     Performance approach. The meetings will focus on problem solving for daily life situations     and on the ability to implement the discussed strategies for a variety of activities.     Participants will be evaluated at baseline, after the intervention, and after 6 months.   "
23533|NCT02977611|"     Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough     iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce     hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it     cannot produce enough hemoglobin and you become anemic.      The research study is looking at the side effects of using a higher dose and faster rate of     iron sucrose infusion than what is used in standard of care. The purpose of this study is to     see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely.     If this can be done safely, it may reduce the total number of infusions required and the time     for each infusion. This may be less costly and less burdensome to patients.   "
23534|NCT02977598|"     In this study, the investigators aimed to find out whether there is any association between     the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the     well-known diabetic risk factors, the investigators purposed to reveal new ones.   "
23535|NCT02977585|"     Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign     to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients     enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25     patients at least.        -  10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU          admission (random 1)        -  5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and          respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2          occurs in the following first hour after Helmet CPAP treatment start, patients enrolled          will receive endotracheal intubation, full face mask non invasive ventilation or higher          peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.      In investigator's experience, early worsening of severe bronchiolitis in PICU in the first     hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.   "
23536|NCT02977572|"     The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV)     performs better than a Continuous Positive Airway Pressure (CPAP) in the management of     Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting.   "
23537|NCT02977559|"     The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable     Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.      The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during     mechanical ventilation despite differences in their structural design.   "
23828|NCT02971787|"     To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative     abundance of gut lactobillus species in healthy men   "
23538|NCT02977546|"     Determination of hemodynamics plays an important role in the diagnosis of chronic heart     failure. The gold standard is intermittent thermodilution via pulmonary artery catheter     (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to     the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.     Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine     hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery     Catheterization include a lower risk and an operator-Independent easy handling. Some studies     investigated the accuracy, precision and trending abilities of noninvasive pulse contour     analysis during anesthesia and in the intensive care unit, but there is no data available for     its use in patients with chronic heart failure. The investigators therefore initiated this     Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with     chronic heart failure.   "
23539|NCT02977533|"     Primary Objective:      To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in     men and women with progressive multiple sclerosis.      Secondary Objectives:      To assess in men and women with progressive multiple sclerosis:        -  The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose.        -  The pharmacodynamic (PD) response to GZ402668 after a single SC dose.   "
23540|NCT02977520|"     Cerebral aneurysm is one of the main diseases that seriously affect human health. The most     important treatment method is surgical clipping and endovascular embolization. Not complete     occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This     study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined     with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of     aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In     addition, the model can also be used to the young doctor's training, and the patient and     their families can be convenient and intuitive understanding of the disease, so as to form a     good communication between doctors and patients.   "
23541|NCT02977507|"     The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus     4% hydroquinone in the improvement of the appearance of moderate facial melasma.   "
23563|NCT02977221|"     Applying flapless piezocision corticotomies on the alveolar bone and separating anterior     mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very     accurate incisions without any sutures following this procedure) may improve the speed of     tooth alignment during orthodontic treatment. This study consists of two groups, patients     will be randomly assigned to one of these two groups. The efficacy of this procedure on 18     patients (experimental group) will be evaluated,whereas the second group (control group) will     receive a traditional orthodontic therapy. The time required to achieve complete alignment of     crowded mandibular anterior teeth (from canine to canine) will be compared between the two     groups.   "
23542|NCT02977494|"     Myeloma patients with renal impairment need a rapid and effective reduction of tumor burden     to enable renal recovery, which is correlated with prognosis of the patients. However,     effective combination regimens are often hampered by necessary dose reductions or increased     toxicity in renally impaired patients. The well known positive effects on renal impairment by     Bortezomib combined with Daratumumab, which, as all monoclonal Antibody, is not renally     excreted or metabolized and as so far known should not add significant toxicity but efficacy,     makes the proposed combination of Daratumumab, Bortezomib and Dexamethasone highly attractive     for renally impaired MM patients.      In the current clinical trials with Daratumumab patients with renal function impairment (GFR     ≤ 20 ml/min) were so far excluded. Consequently questions about efficacy, safety and     pharmacokinetics of Daratumumab in combination with Bortezomib and Dexamethasone in patients     with relapsed and refractory MM and severe renal impairment are still unanswered. This trial     will answer these questions for a patient group, who has still an unmet need for novel and     effective treatment options   "
23543|NCT02977481|"     Ear thermometers are often requested to be used rather than rectal thermometer (gold     standard) for measuring the body temperature, as this method is faster and more user     friendly. Former ear thermometers did not meet the required standards of accuracy for     clinical use. However, a new generation of ear thermometers have been developed and widely     used in the Emergency departments in Denmark. The devices have only been evaluated in two     studies on adult populations, with conflicting results.      This cross-sectional study will examine patients by measuring both ear and rectal temperature     in the same patient at the same time on admission to an emergency department, to evaluate if     temperature measured in the ear can be used as the standard temperature measurement.   "
23544|NCT02977468|"     Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating     lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC)     patients.      Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and     intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses     of MK-3475 prior to lumpectomy.   "
23545|NCT02977455|"     Existing researches show that brain is an organ highly dependent on continuous blood supply.     Energy and oxygen required for normal physiological activities in the brain are stably     maintained by a neurovascular regulatory mechanism, also known as functional congestion.     While under pathological condition such as ischemia, this regulatory mechanism would be     impaired and brain function loss and tissue damage occur. During anesthesia in cardiac     surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and     cerebral blood flow and therefore brain tissue is in ischemia. In this situation the     neurovascular regulatory mechanism will function and the brain oxygen saturation also changes     based on how this mechanism is influenced. the investigators were devoted to observe how this     mechanism was influenced during surgery and how the neural function recovers after surgery so     to explore the relationship between them.   "
23576|NCT02977052|"     This is an open-label three-arm phase 2 trial (including a Simon stage 2 design) consisting     of 90 stage III melanoma patients randomized 1:1:1 to receive either 2 courses 3 mg/kg     ipilimumab + 1 mg/kg nivolumab every 3 weeks (Arm A), 2 courses 1 mg/kg ipilimumab + 3 mg/kg     nivolumab every 3 weeks (Arm B), or 2 courses ipilimumab 3 mg/kg, directly followed by 2     courses nivolumab 3 mg/kg every 2 weeks (Arm C). All three treatment arms are applied prior     to surgery at week 6, 30 patients per arm. Patients will be stratified according to treatment     center. An interim analysis will be performed after 13 patients have been included in each     arm, thus in total 39 patients have been included.   "
23546|NCT02977442|"     Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells     for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes     occurs when the cells of the body become resistant to the effects of insulin, and this causes     high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the     heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed     at preventing and treating type 2 diabetes.      Mitochondria are cellular structures that are responsible for turning nutrients from food,     into the energy that our cells run on. As a result, mitochondria are known as the powerhouse     of the cell. Mitochondria are dynamic organelles that can move within a cell to the areas     where they are needed, and can fuse together to form large, string-like, tubular networks or     divide into small spherical structures. The name of this process is mitochondrial dynamics     and the process keeps the cells healthy. However, when more food is consumed compared to the     amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a     leak of partially metabolized nutrients that can interfere with the ability of insulin to     communicate within the cell. This may be a way for the cells to prevent further uptake of     nutrients until the current supply has been exhausted. However, long term overload of the     mitochondria may cause blood sugar levels to rise and lead to the development of type 2     diabetes.      This study will provide information about the relationship between mitochondrial dynamics,     insulin resistance and type 2 diabetes.   "
23547|NCT02977429|"     This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy     and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal     tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect     of these patients.   "
23548|NCT02977416|"     During exercise, energy comes mainly from carbohydrates and lipids. The relative contribution     of lipids and glucose as energy substrates to exercise depends on the parameters of the     exercise (duration, intensity and level of training) and the physiological conditions of the     subject.      Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most     severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines     including TNFα. In adults with rheumatoid arthritis several studies have shown that treatment     with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of energy     substrates during exercise in children and adolescents with AJI, nor on the impact of     anti-TNFα treatments on the oxidation of energetic substrates in children.      Investigators hypothesize that, compared to healthy children, children with JIA should     exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due     to physical deconditioning and inflammation. In addition, those treated with anti-TNFα should     have an oxidation profile of energy substrates at exercise different from that of patients     not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα treatments modify     the contribution of energy chains (aerobic, anaerobic and anaerobic alactic) during the     exercise.   "
23564|NCT02977208|"     This study aims to evaluate the influence of genetic polymorphisms of OCTN1 and OCT2 and     other possible covariates on the kinetic disposition of GAB in patients undergoing GAB     chronic treatment. Thus, patients treated with GAB, for at least one week, are being     investigated.   "
23705|NCT02975375|"     The investigators will conduct a population-based study using health administrative data to     evaluate the impact of preoperative geriatric consultation on postoperative outcomes in older     patients having elective, non-cardiac surgery   "
23549|NCT02977403|"     Background:      People are constantly exposed to unhealthy foods. Some studies of adults show that training     attention away from unhealthy foods might reduce overeating. Researchers want to see what     happens in the brain when teens train their attention away from food through a program on a     smartphone.      Objective:      To study the relationship between eating patterns, body weight, and how the brain reacts to     different images.      Eligibility:      Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th     percentile for age).      Design:      Participants will have 6 visits over about 8 months.      Visit 1: participants will be screened with:      Height, weight, blood pressure, and waist size measurements      Medical history      Physical exam      Urine sample      DXA scan. Participants will lie on a table while a very small dose of x-rays passes through     the body.      Questions about their general health, social and psychological functioning, and eating habits      Parents or guardians of minor participants will answer questions about their child s     functioning and demographic data.      Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will     include some or all of these procedures:      Blood drawn      MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in     a strong magnetic field. A device will be placed over the head.      Meals provided. Participants will fill out rating forms.      Simple thinking tasks      A cone containing magnetic field detectors placed onto the head      Medical history      Physical exam      Urine sample      Participants will be assigned to a 2-week smartphone program that involves looking at     pictures. Participants will complete short tasks and answer some questions about their eating     habits and mood on the smartphone.   "
23550|NCT02977390|"     This is a pilot study to investigate whether patients at advanced age are fluid responders     via a reversible fluid challenge, the passive leg raise test. This will be measured with a     non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .   "
23551|NCT02977377|"     To investigate the effects of whole body vibration on postural control and on the level of     satisfaction regarding how to reach the goals of the patients with ataxia   "
23552|NCT02977364|"     To investigate safety, tolerability and pharmacokinetics of C-met Kinase Inhibitor HS-10241     in Subjects With Advanced Solid Tumours that are not eligible for conventional or intensive     treatment. The dose of HS-10241 will be escalated to determine the dose limiting toxicity     (DLT) and the maximum tolerated dose (MTD) of HS-10241 in advanced cancer patients. At the     same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 will be     observed in advanced cancer patients. To determine the recommended dosage regimen for phase     II.   "
23553|NCT02977351|"     Determine the relationship between the systemic indications of atherosclerosis by means of     the change in the ratio of periodontopathogenic microorganisms following periodontal     treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis     and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.   "
23577|NCT02977039|"     The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR)     diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular     risk in individuals with type 2 diabetes and overweight/obesity.   "
24043|NCT02970955|"     Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except     for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body     radiation therapy (SBRT).   "
23554|NCT02977338|"     Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic     upper airway evaluation during artificial sleep before surgical treatment for patients with     obstructed sleep apnea (OSA).      DISE is a safe procedure, easily practicable, valid and reliable. The investigators consider     it a fundamental clinical procedure that is essential before choosing the surgical treatment.     The investigator's results so far suggest that a multilevel collapse is significantly     associated with higher apnea hypopnea index values. The investigators think that the weight     did not play a significant role in RDI reduction. Results till now show that tailored surgery     based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate     based on the investigator's experience The aim of this study is to evaluate surgery results     in patients who underwent DISE prior to their surgery in comparison to their condition prior     to the treatment.   "
23555|NCT02977325|"     Questionnaires are often irreplaceable tools of collection of information in research and in     the clinical practice. Coupled with other measures, they can be simple complementary tools,     but questionnaires are sometimes the only way to collect data, such as self-service efficacy.      The objective of this study is a validation of the French translation of the ASES. To     guarantee the comparability between the original version and the translated version, the     translation of a questionnaire supposes two essential stages: a literal translation and an     adaptation to the cultural context, to the habits of life and to the idioms of the target     population. This new version will afterward be validated with patient's troop.   "
23556|NCT02977312|"     This study assessed the efficacy and safety of generic imatinib in patients with chronic     myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label,     prospective study combined with retrospective data collection from files of patients with a     diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s)     additional to the daily practice were performed   "
23558|NCT02977286|"     This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in     critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the     participants will receive naloxegol and a laxative protocol and half the participants will     receive a placebo and a laxative protocol.   "
23559|NCT02977273|"     Meal size is strongly influenced by a number of external features of the food environment     which can promote over-consumption, such as the availability of palatable energy dense foods     and large portion sizes. The current research aimed to investigate whether natural food-based     differences in texture could be used to slow down eating rate and reduce intake from large     portions.      A four-session randomised crossover study assessed the effect of faster vs. slower eating     rate, achieved through manipulating food texture, on ad-libitum consumption (weight and     calories) of a meal, alone and in combination with variations in meal portion size (regular     vs. large)   "
23560|NCT02977260|"     Meal size is strongly influenced by a number of external features of the food environment     which can promote over-consumption, such as the availability of palatable energy dense foods.     The current research aimed to investigate whether natural food-based differences in texture     could be used to slow down eating rate and reduce intake from large portions and higher     energy dense foods.      A four-session randomised crossover study assessed the effect of faster vs. slower eating     rate, achieved through manipulating food texture, on ad-libitum consumption (weight and     calories) at a meal, alone and in combination with variations in meal energy-density (higher     vs. lower)   "
23561|NCT02977247|"     The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear     ring‐array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and     K142517 for use as both a B‐mode ultrasonic breast imaging system and color imaging of     transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a     replacement for screening mammography.      SoftVue uses non‐ionizing ultrasound energy to generate tomographic image volumes of the     whole breast. While the patient lays prone on a padded table with one breast comfortably     submerged in a bath of warm water, a ring‐shaped transducer, 22 cm in diameter, encircles the     breast and pulses low‐frequency sound waves through the water and into the breast tissue.     More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive     ultrasound signals to analyze echoes from the breast anatomy in all directions, from the     chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound     waves off of tissue boundaries and structures within the breast, but because the transducer     surrounds the whole breast, SoftVue also captures signals that are transmitted through the     breast. This additional transmission data enhances the visualization of the anatomic     structure of the breast tissue and is not currently available in any other commercially     marketed breast ultrasound device.      This prospective, multicenter, multi‐arm, clinical case collection program is IRB‐approved     and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki     and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000     women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly     limited to case collection and is non-interventional; any investigational and/or statistical     plans for future analyses will be prepared and registered separately, if they are applicable     to the requirements of FDAAA 801.      Arm 2 is limited to the cohort of diagnostic female patients of any breast density     composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after     diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic     imaging and SV exams, from the same patient, demographic information, and clinical outcome     data, will be collected during diagnostic workup. Ultrasound characteristics for all types of     lesions, whether they are benign or malignant, will be collected as well as objective and     subjective breast density composition data. Ultrasound image data may be acquired with     modified SoftVue devices, which have passed safety and quality evaluations per Delphinus'     quality management system (QMS) and satisfy design change control standards, at select     clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility,     validation, and verification testing for engineering and product development purposes.      The exams and clinical data accumulated in this prospective case collection (PCC) protocol     will populate a database from which future investigations may be designed for peer reviewed     publication, development of user training curricula, building teaching case, and creating new     marketing materials for SoftVue.   "
23565|NCT02977195|"     For most advanced solid tumors, current therapy is inadequate at improving quality of life,     slowing progression of disease, prolonging survival, and providing a cure. Hence, there is a     continuous need for innovative, safer and more effective anti-cancer therapies. Our study is     based on the dependence receptor paradigm and the associated therapeutic strategy. In     preclinical models, preventing Netrin-1 interaction with its receptors is sufficient to     trigger Netrin-1-expressing tumor cell death in vitro as well as tumor growth and metastasis     inhibition in vivo. This indicates that a therapeutic approach based on Netrin-1/Netrin-1     receptors interaction inhibition is both feasible and promising. NP137 is a first-in-class     humanized monoclonal antibody targeting the Netrin-1 ligand, a secreted protein recently     described as a driver of tumor initiation and progression. NP137 demonstrated anti-tumor     activity as a single agent in several pre-clinical models of cancer, including breast and     lung cancer. Taken together, several studies strongly support the rational for preclinical     development and clinical evaluation of a highly potent and selective anti-Netrin-1 antibody     in cancer patients. The proposed study is an open label, multicenter, Phase I dose escalation     study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and     preliminary anti-tumor activity of NP137 administered every 2 weeks (Q2W) as single agent in     patients with locally advanced or metastatic solid tumors. This trial will be the First in     Human (FIH) study for NP137; there is no clinical experience with this antibody in the     clinic. Dose escalation part will define the Maximum tolerated dose and the Recommended Phase     II dose (MTD /RP2D) of NP137 and Expansion part will assess the PD and anti-tumor activity of     NP137.   "
23578|NCT02977026|"     Alcohol is one of the leading contributors to premature mortality and disability. Most people     with alcohol problems will never seek treatment. There is a need to develop alternate ways to     help problem drinkers outside of formal treatment settings.      One promising strategy is Internet-based interventions for problem drinkers. Our recently     completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help     Centre; AHC) Internet intervention for problem drinkers found that, while there was a     reduction in drinking across time for both interventions, there was no significant (p > .05)     difference in reductions in drinking between the two interventions. Based on these results,     it is not justifiable to say that either intervention 'worked' as there was no comparison     condition of participants who received no active intervention. The current trial proposes to     address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention     control condition.      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants     identified as problem drinkers based on an initial survey will be invited to complete another     survey in 6 months time. Those who are interested will be randomized to receive access to the     Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC condition) or a     feedback questionnaire (control condition). At six-months post-baseline, the MTurk portal     will be used to send invitation emails that contain a link to the follow-up survey. The     primary hypothesis to be tested is that participants receiving access to the AHC intervention     will report a greater reduction in AUDIT-C scores and in number of drinks in a typical week     than participants in the CYD intervention. Further, participants in the CYD condition will     report a greater level of reduction AUDIT-C scores and in number of drinks in a typical week     between the baseline survey and six-month follow-up as compared to participants in the no     intervention control condition.   "
23579|NCT02977013|"     The aim of the present study is to monitor anticoagulant therapy by anti-Xa assay and     correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary     embolism.   "
23566|NCT02977182|"     Injuries to the face caused by traumatic events such as motor vehicle collisions, assault,     and falls can result in facial trauma, which can result in swelling and disfiguration that     impairs the important functions of the face, sometimes to a life threatening degree. These     injures and the resultant swelling can also precipitate psychological and social     consequences.      Lymphedema is an abnormal amount of fluid that causes swelling, usually in the arms or legs.     The most common presentation of lymphedema is in the upper extremities due to breast cancer     treatment (Maclellean RA et al). As such, standards of care for management of lymphedema are     primarily derived from the cancer research literature and involve the extremities (Moffatt     CJ. 2003 QJM). The current gold standard treatment for patients with extremity lymphedema is     complete decongestive therapy (CDT) (Zuther 2013). CDT is a multimodal therapy consisting of     four components: manual lymph drainage, compression wrapping, exercise, and skin care (Zuther     2013).These same therapeutic techniques of CDT have been employed at Our Lady of the Lake     Regional Medical Center (OLOLRMC) and adapted to treat patients with facial trauma with     anecdotally good results primarily related to cosmesis. To the best of our knowledge, no     clinical studies examining the effect of lymphedema treatment in the management of blunt     facial trauma currently exist.. Beyond the consideration of cosmesis, we also seek to     determine if this intervention improves clinical outcomes such as time to swallowing and     reduced time utilizing mechanical ventilation. This study will prospectively evaluate the use     of complete decongestive therapy to test the hypothesis that this intervention results in     improved clinical outcomes in patients with blunt facial trauma.   "
23567|NCT02977169|"     Rationale: Completely resected non-small cell lung cancer (NSCLC) patients with     histologically confirmed N2 disease are a heterogeneous population, with 5-year survival     rates ranging from 10% to 30%. Systemic recurrence following surgery is one of the major     problems in stage IIIA(N2) patients, and the use of postoperative chemotherapy (POCT) in     stage IIIA disease prolongs survival. The value of postoperative radiotherapy (PORT) for     completely resected NSCLC remains controversial, as the effect on survival has been     inconclusive. Recently, several large retrospective studies and reviews of the National     Cancer Database indicated that modern PORT appears to confer an additional 5% survival     advantage beyond that achieved with adjuvant chemotherapy alone. Actually, after complete     resection and POCT, 20%-40% of cases have a risk of locoregional recurrence (LRR). Patients     with completely resected stage IIIA(N2) disease might hold different postoperative     patterns-of-failure and prognosis. It is not yet known for subsets with specific prognostic     factors that confer lower LRR risks, whether giving PORT is more effective than no radiation     therapy in treating patients with completely resected pathologic stage IIIA(N2) NSCLC.      Purpose: This randomized phase II trial is studying the clinical efficacy of PORT     administered using three-dimensional conformal radiotherapy (3D-CRT) techniques and the     proposed standard PORT clinical target volume (CTV) delineation guideline in treating low     risk of LRR patients with completely resected pathologic stage IIIA(N2) NSCLC.   "
23568|NCT02977156|"     The success of anti-CTLA4 therapy has inaugurated a paradigm shift in oncology where drugs     target the immune system rather than cancer cells in order to stimulate the anti-tumor immune     response. In situ immunization is a strategy where immunomodulatory products such as     pathogens are injected into one tumor site in order to trigger a systemic anti-tumor immune     response. Of importance, pre-clinical rationale has demonstrated that combination of     anti-CTLA4 therapy together with intra-tumoral (IT) oncolytic virus can overcome primary     resistance to systemic anti-CTLA4 therapy. Pexastimogene Devacirepvec (Pexa-Vec) is one of     the new vaccinia oncolytic viruses genetically modified to express GM-CSF. This new and     innovative oncolytic virotherapy should therefore synergize with anti-CTLA4 therapy via     virus-induced tumor cell death & tumor-antigen release, GM-CSF-induced     recruitment/maturation/activation of antigen presenting cells, and anti-CTLA4-induced Treg     blockade/depletion. Intra-tumoral delivery of immunostimulating agents should, therefore,     provide lower toxicity of mAb targeting immune checkpoints. Of note, IT injections of     GM-CSF-encoding oncolytic viruses have already been shown to induce immune-mediated tumor     responses on local (injected) and distant (not injected) tumor sites. In solid injectable     refractory/relapsing metastatic tumors, we make the hypothesis that the addition of Pexa-Vec     to IT ipilimumab (anti-CTLA4 Ab) will overcome primary/secondary resistance to standard     therapy and/or immunotherapy with a better in situ tumor antigen specific T-cell priming. Our     proposal is to conduct a 2-part Phase I clinical trial in order to define the feasibility,     the safety and the anti-tumor effects of intra-tumoral injections of ipilimumab in     combination with the oncolytic virus Pexa-Vec. Dose escalation step will define the MTD and     RP2D of that in situ immunization strategy. Expansion part will assess the anti-tumor effect     of the combination.   "
23569|NCT02977143|"     In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload     and cardiac output is important for clinical prognosis. Previous studies reported the     positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP)     could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The     authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as     stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.   "
23595|NCT02976805|"     This is a multi-centre randomized clinical trial comparing the efficacy of two different     bowel preparation regimens for patients who have already failed a bowel preparation for     colonoscopy.   "
23570|NCT02977130|"     The American Diabetes Association indicates that diabetes self-management is a skill that     diabetic patients must learn in the Diabetes Self-Management Education; thus, this     contributes to shared care for diabetes, in which teams of physicians, professional nurses,     and dietitians offer shared care to patients. However, according to the statistical analysis     of the conditions of glycemic control in diabetic patients in 28 countries across 4     continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of     the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among     diabetic patients in a shared-care program found that the percentage of patients with HbA1c     lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed     both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1%     during that period. These results suggest that despite the increase in the proportion of     patients who successfully managed their diabetes, some patients still encountered difficulty     in glycemic control.Therefore, numerous health education tools on diabetes continue to be     developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial     influence on the dietary habits of diabetic patients, and that individual health education     had the largest effect on diabetes control. In addition, using the conversation map for     diabetes control also had a substantial influence on improving health behaviors. Among     existing studies that have adopted the conversation map, no large-scale research has been     conducted, the research samples and relevant studies in Taiwan have been scant, and no     theoretical foundation has been applied in evaluating the effects of the conversation map.     Accordingly, the investigators aimed to enhance the mutual experience exchange and learning     among diabetic patients through adopting the conversation map to observe its influence on     their health behaviors by incorporating it into existing health education modalities.     Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed     for assessing the effectiveness of glycemic control in diabetic patients.   "
23571|NCT02977117|"     The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum     calcification propensity in subjects with end-stage renal disease treated with haemodialysis.   "
23572|NCT02977104|"     The purpose of this study is to demonstrate that the Maestro hand held heart monitor can     accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.   "
23580|NCT02977000|"     Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in     children in both developing and developed countries around the world. ROP is a multifactorial     disease characterized by perturbation of normal vascular development in the retina. The     pathogenesis of ROP is hypothesized to consist of two distinct phases of which the second     phase is characterized by hypoxia-induced up-regulation of vascular endothelial growth factor     (VEGF) and retinal neovascularization.      Recent studies have shown a relationship between the β-adrenergic system and angiogenesis.     This relationship has been observed in several diseases, like infantile hemangiomas, ROP, and     neoplasias. Studies in animal models have shown that norepinephrine stimulates VEGF     expression and secretion in retinal cells. In oxygen induced retinopathy, blockage of     β-adrenergic receptors (β-AR) can inhibit the angiogenic cascade and interfere with further     proliferation of retinal vasculature. Also, angiogenesis seems to be impaired in β-Argene     deficient mice, when exposed to hypoxia and other stimuli, but this function is restored     after gene therapy.      Assuming in human preterm newborns with ROP that VEGF overexpression and retinal     neovascularization in response to hypoxia might involve b-AR activation, we design     prospective randomized study to assess the effect of oral propranolol on the progression of     early stages of ROP in very low birth weight infants.   "
23610|NCT02976610|"     This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of     care test is introduced in an emergency department.   "
23731|NCT02975037|"     Evaluation and validation of metabolic markers for the prediction of drug-drug interaction of     various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in healthy     male subjects   "
23581|NCT02976987|"     The infections of high grade induced by the human papilloma viruses cause precancerous     lesions of the cervical epithelium. The progression of these lesions can lead to the onset of     cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous     intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3'     (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to     complications such as infertility or a risk of preterm birth, hence the need to move towards     a non-surgical alternative therapy.      The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy     study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix     exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).      This clinical trial is a prolongation of the colvir trial, in order to        -  assess the long term histological and virological evolution (24 months) of 3 g of 2%          (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade          intraepithelial neoplasia after complete response, partial response or response failure          at the end of the Colvir study.        -  assess the long term (24 months) rate of recurrence of histological lesions of the          Colvir patients after conisation, in both placebo and treatment groups.   "
23582|NCT02976974|"     The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive     capsulitis of the shoulder will be studied. Furthermore, different biomechanic and     psychosocial factors will be measured with a nine month follow-up   "
23583|NCT02976961|"     This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care     innovation as add-on to usual care as compared to usual care alone in patients with an     implantable cardioverter defibrillator.   "
23584|NCT02976948|"     Main objective: To compare the efficacy of a new strategy of Next Generation Sequencing (NGS)     versus a classical Sanger strategy, for the diagnosis of patients referred to the laboratory     for suspected systemic autoinflammatory diseases (SAID).      Secondary objectives:        -  Compare after 6 months the impact of these strategies on the establishment of an          effective treatment SAID following genetic result.        -  Compare the distribution of different forms of SAID found with each genetic diagnostic          strategies (NGS vs classic method).   "
23585|NCT02976935|"     The aim of this study is to investigate the potential value of a novel imaging technique     (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in     patients with COPD and IPF.   "
23586|NCT02976922|"     Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases affecting     the oral mucosa. The aetiology remains unknown, but several local, systemic, immunologic,     genetic, allergic, nutritional, and microbial factors have been proposed as causative agents.     Clinically, RAS is characterised by recurrent bouts of one or several rounded, shallow,     painful oral ulcers at intervals of a few months or days. The aim of this study is to     characterise the salivary and faecal microbiome in 20 patients with RAS and compare the     findings with those of 20 healthy controls. The study also includes a double-blind randomized     placebo-controlled intervention with probiotics (Lactobacillus reuteri-containing lozenges 2     tablets daily for 3 months) or placebo. The salivary and faecal microbiome in RAS patients is     compared before and after treatment. This study will improve our understanding of the     pathogenesis in RAS and provide us with knowledge on potential future therapeutic approaches.   "
23587|NCT02976909|"     Paclitaxel In combination with DDP and 5-FU(TPF) as neoadjuvant chemotherapy in treating     boundary resectable locally advanced esophageal squamous cell carcinoma: A phase II clinical     trial.   "
23588|NCT02976896|"     We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib     Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the     failure of conventional treatments. An exploratory molecular marker analysis will be     performed in order to find out the beneficial population of Apatinib Mesylate.   "
23589|NCT02976883|"     The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection     of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a     diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up     data will be collected from routine appointments, and analysed with the hypoxia scan results     to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy     treatment.   "
23617|NCT02976519|"     The objective of this study is to investigate the safety, tolerability, and pharmacokinetics     of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).   "
23618|NCT02976506|"     To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over     blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive     patients.   "
23590|NCT02976870|"     Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient     in order to access the spine. During this process, several internal structures are pushed     aside in order to gain access. One of these structures is the ureter, whose function is to     drain urine from the kidney to the bladder. One potential complication that can arise from     this is dilation of the kidney - known as hydronephrosis. The aim of this study is to     identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is     complication, in order to bring this to the attention of health care professionals when     considering this kind of surgery.   "
23591|NCT02976857|"     The trial is a single arm, single-center, non-randomized phase I clinical trial which is     designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL   "
23592|NCT02976844|"     Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The     volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure.     The optimal balloon volume is directly dependent on surrounding pressure. In the present     study,the investigators will observe the optimal volume of esophageal balloon during the     different PEEP in bench and clinical study.   "
23593|NCT02976831|"     Plaque psoriasis vulgaris is a chronic inflammatory skin disorder, affecting 1-3% of the     population in Europe and the United States of America (USA) and represents one of the most     prevalent immune inflammatory diseases. AZD0284 is a potent selective inverse agonist of     RORg, which is being developed for the management of psoriasis. The current Phase 1 study     investigates the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic     (PD) properties of single and repeated doses of AZD0284. The study will be conducted in     healthy subjects. The study will be divided into 2 parts: Part 1 (SAD) and Part 2 (MAD), with     Part 1 being split into 2 sub-parts: 1A (fasting) and 1B (fed). The results from this study     will form the basis for decisions on future studies. The study will help to identify     appropriate, well-tolerated doses that can be administered in subsequent studies in patients     with psoriasis.   "
23594|NCT02976818|"     Aortic valve stenosis (AVS), the most common form of valve disease in the western world,     afflicts more than 1 million individuals in North America [1] and the burden of AVS is high     and is expected to double within the next 50 years [2]. Medical therapy to prevent     development or reduce progression of AVS is currently not available and the only effective     treatment for AVS is aortic valve replacement, for which costs have been estimated up to     120,000$ [3,4]. Recently, we and others have identified rs10455872 at the LPA locus as a     susceptibility single nucleotide polymorphism (SNP) for aortic valve calcification (AVC) and     AVS [5,6] and rs10455872 is associated with elevated plasma lipoprotein (Lp)(a) levels [7].     Lp(a) is a LDL-like particle consisting of hepatically synthesized apolipoprotein B-100 that     is noncovalently bound to the plasminogen-like glycoprotein apolipoprotein(a) [8]. Lp(a)     promotes atherosclerotic stenosis, and possibly thrombosis, and has been hypothesized to     contribute to wound healing, each of which could explain an association with AVS [9,10].     Lp(a) is relatively refractory to both lifestyle and drug intervention, with only nicotinic     acid and monoclonal antibody inhibition of the proprotein convertase subtilisin/kexin type 9     that have showed reductions in Lp(a) levels [11,12]. However, the evidence that patients with     AVS could be characterized by high Lp(a) levels is scarce. Glader et al. [13] showed that     plasma levels of Lp(a) were almost 1.5-fold higher in 101 patients with AVS compared to     matched controls, although this relationship did not reach statistical significance.     Subsequent studies have also reported an association between elevated plasma Lp(a) levels and     higher prevalence of AVS. More specifically, Kamstrup and colleagues [14] reported that     elevated Lp(a) levels and corresponding genotypes were associated with increased risk of AVS     in the general population with levels >90 mg/dL predicting a threefold increased risk. We     have measured Lp(a) and oxidized phospholipids plasma levels in 220 patients with     mild-to-moderate calcific AVS enrolled in the Aortic Stenosis Progression Observation:     Measuring Effects of Rosuvastatin (ASTRONOMER) trial [15]. Results of this study suggest that     high Lp(a) and oxidized phospholipids both predict calcific AVS progression, especially in     younger patients with calcific AVS. We also found that statin therapy considerably increased     both Lp(a) and oxidized phospholipids levels. Whether the fact that statins increase these     risk factors for calcific AVS might explain at least to a certain extent why statins failed     to promote calcific AVS regression or stabilization in at least four trials, including     ASTRONOMER.      Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by     mutations in the LDL receptor gene that disrupt normal clearance of LDL. Phenotypic features     characteristic of the disease's heterozygous form are 2- to 3-fold raise in plasma     LDL-cholesterol concentrations, tendinous xanthomatosis and premature atherosclerotic     coronary artery disease. High Lp(a) levels have been shown to explain residual cardiovascular     disease risk in FH [16,17]. Recent studies have demonstrated that FH heterozygotes have     elevated AVC compared with non-FH subjects [18] and that Lp(a) levels were positively     correlated with AVC in asymptomatic FH heterozygotes [19]. Vongpromek et al. [19]     demonstrated that plasma Lp(a) concentration is a independent risk factor for AVC in a cohort     of 129 asymptomatic heterozygous FH patients aged between 40 and 69 years. In this study, AVC     was significantly associated with plasma Lp(a) level, age, body mass index, blood pressure,     duration of statin use, cholesterol-year score and coronary artery calcification (CAC) score.   "
23596|NCT02976792|"     Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic     Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI)     early enough to prevent an organic dysfunction triggering, consequently, cortical tubular     necrosis.      Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal     Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly.     These markers, sonographic and biologic, have both the advantage to be non-invasive and easy     to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly     after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential     tests to guide clinicians in determining rapidly whether a patient will develop AKI after a     TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing     TAVI.      Therefore, the aim of this prospective observational study will be first to determine the     effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure.     The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an     earlier stage than the traditional method an AKI.   "
23597|NCT02976779|"     This single center, prospective, double-blind, placebo-controlled, randomized two parts study     (part I and part II) will assess the safety of topical cream (3% CBD and 3% THC), applied     twice daily (bid), in healthy subjects, for up to 6 treatment weeks and additional 2     follow-up weeks.   "
23598|NCT02976766|"     The purpose of this study is to determine whether gypenosides are neuroprotective in patients     with acute optic neuritis.   "
23599|NCT02976753|"     The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional     factor products in the prophylactic treatment of patients with haemophilia A over a 24-month     prospective period. Data will also be collected for a 12 month retrospective period.   "
23600|NCT02976740|"     The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)     combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and     Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in     second-line chemotherapy.   "
23601|NCT02976727|"     Vitamin D(Vit D) is a pro-differentiation agent that enhances the accumulation of     protoporphyrin IX (PpIX) after MAL(methyl-aminolevulinate) incubation in actinic keratosis     and may have significant benefit for the treatment of actinic keratosis by ablative     fractional laser-primed photodynamic therapy (AFL-PDT).   "
23602|NCT02976714|"     The general aims of this project are (i) to identify predictive epigenetic biomarkers of lung     disease severity in Cystic Fibrosis, (ii) to characterize a non-invasive cellular model,     spontaneous sputum, for the analysis of these epigenetic biomarkers, (iii) to analyze the     variations in DNA methylation for a same patient over time.   "
23603|NCT02976701|"     This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study     over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary     PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the     study.   "
23619|NCT02976493|"     BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of     elotuzumab in clinical practice in Japan.   "
23620|NCT02976480|"     The purpose of this study is to determine whether the irrigation or non-irrigation of a     simple laceration treated in the emergency department has an effect on the subsequent rate of     infection.   "
23621|NCT02976467|"     The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor     BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period     in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI).     BAY1142524 or placebo will be given on top of evidence-based standard of care for     left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis     of first signs of efficacy as determined by favourable changes in functional parameters of     adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection     fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the     incidence and severity of adverse events. 30 patients have to complete treatment with verum     and 30 patients have to complete treatment with placebo.   "
24045|NCT02970929|"     An extension study of safety and tolerability of SEP-363856 in adult subjects with     schizophrenia   "
23604|NCT02976688|"     End-stage renal disease (ESRD) is associated with multiple comorbidities such as     cardiovascular disease, anemia, mineral and bone disorders, malnutrition, body wasting,     muscle loss (sarcopenia), neurological problems and infections resulting in a poor survival.      In the pathogenesis of the uremic syndrome the altered intestinal function seems to be an     important contributor. While the normal gut microbiota plays a prominent role in the     maintenance of health and disease prevention, changes of its composition is associated with     numerous diseases such as obesity, type 2 diabetes, cardiovascular disturbances and     auto-immune diseases.In ESRD metabolic alterations of uremia results in quantitative and     qualitative changes of its bacterial flora with an overgrowth of pathobionts (1). Due to     concomitant disruption of the intestinal barrier function, noxious luminal products are     translocated in the body's internal milieu (2).The accumulation of these compounds correlates     with systemic inflammation, protein wasting and accelerated cardiovascular complications in     hemodialysis patients (3).      Short-chain fatty acids (SCFA) are produced in the colon and distal small intestine by     anaerobic bacteria following fermentation of complex carbohydrates.They have been shown to     exert anti-inflammatory, anti-cancer, antibacterial and antidiabetic effects (4).     Supplementation of SCFA exerts anti-inflammatory actions both in intestinal epithelial cells     (5) and in the cardiovascular system (6). They also positively influence auto- immune     reactions /diseases (7,8).      In this study we want to investigate in MHD patients whether a treatment with SCFA in form of     sodium propionate (SP) modulates the systemic inflammation, insulin resistance and     accumulation of intestinal uremic toxins.   "
23605|NCT02976675|"     To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children     with growth hormone deficiency, as well as to study the feasibility of extending the dosing     intervals (once per two weeks) of PEG Somatropin Injection.   "
23606|NCT02976662|"     Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating     a large hole in the zona pellucida at the cellular junction of the trophectoderm cells     located far away from the inner cell mass with a laser pulse before vitrification.   "
23607|NCT02976649|"     The purpose of this study is to propose a multi-dimensional score to predict those patients     undergoing bariatric surgeries who will be in need for postoperative ICU admission.   "
23608|NCT02976636|"     The purpose of this application is to evaluate whether a pediatric weight control program     that incorporates comprehensive parenting training with behavioral therapy can increase     weight loss in children compared to traditional family-based behavioral therapy programs.     Since certain parenting styles are associated with greater weight loss during interventions     and appear to enhance the impact of key behavioral strategies, adding parenting training to     these interventions may increase the overall effectiveness of these programs and increase our     ability to help children obtain a healthy weight. This project could result in identifying an     improved method of pediatric obesity treatment that provides additional benefits to the     growth and development of children via improved self-regulatory behaviors.   "
23609|NCT02976623|"     The investigators hypothesized that feedback based on previously developed and validated     metrics will improve novices' learning of procedural skills.      The objective of this study was to determine the effect of a structured, objective and     terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided     axillary brachial plexus block.   "
23611|NCT02976597|"     Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that     involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides     adequate post-operative pain relieve following the various abdominal surgeries.     Theoretically, TAP block may replace the need for epidural analgesia after abdominal     operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by     (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior     abdomen.   "
23612|NCT02976584|"     Primarily, the investigators want to test the hypothesis that it is possible to detect     epileptiform EEG during cardiac surgery under general anesthesia.      Furthermore, the investigators will examine if those epileptic potentials coincide, follow or     are unrelated to ischemic events detected by EEG or Near-infrared spectroscopy (NIRS).     Finally, the investigators will look for independent associations between intraoperative     seizures (with or without ischemic events) and postoperative neurological outcome, as well as     between intraoperative seizures (with or without ischemic events) and the total amount of TXA     given.   "
23613|NCT02976571|"     A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy,     regarding post operative pain.   "
23614|NCT02976558|"     The allogenic stem cell transplantation (aSCT), the only curative approach for many     hematological diseases, often leads to severe diseases or chronic conditions, leaving     patients with physical disabilities and severe depression and impacting their quality of life     in many cases. These consequences are still not adequately addressed by conventional     therapies. In this study, the investigators examine the influence of the three complementary     medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM),     music therapy according to the TaKeTiNa method and the psychological disease processing by     theatrical clown performance on the quality of life and the therapy process of patients     before and after aSCT.   "
23615|NCT02976545|"     Currently, hypothetical models of understanding Psychogenic Non-epileptic Seizures (PNES)     involve emotional dysregulation.      The hypothesis of a disorder of emotional experience is mainly based on behavioral data and     disturbance of autonomic responses in response to images in emotional content (Mignot et al     2015, in submission; Bakvis et al 2013). Various imaging studies have identified brain     structures belonging to the limbic system in particular that seem functionally impaired in     this population. These functional connectivity abnormalities are correlated with dissociation     scores in PNES patients (Van der Kruijs et al 2012 and 2014).      Investigators propose to specifically study the brain activity of PNES patients during tasks     emotional content to identify the mechanisms involved in this emotional dysregulation. This     work is essential to understanding the mechanisms and the development of new therapeutic     strategies   "
23616|NCT02976532|"     The study is designed to evaluate the use of electromagnetic tracking in femoral derotation     osteotomies. The goal is to raise the precision of the surgical procedure in order to improve     the outcome in short- and long term. The electromagnetic tracking system is evaluated against     a base line CT scan serving as reference standard.   "
23622|NCT02976454|"     One-third of our nations' children are overweight or obese (OW/OB). The cornerstone of     obesity treatment involves intensive family-based behavioral therapy, yet these programs     often exist in tertiary care academic settings that have long wait lists and are too far away     for families to access. Primary care providers (PCP) have been called on by several     organizations to be the front line of obesity management, yet they are limited by a lack of     time, resources, and skills. Thus, if we are to offer effective obesity management in the     healthcare setting, other care models need to be developed and tested. The goal of this     proposal is to deliver Guided Self-Help (GSH) treatment of childhood obesity in the primary     care setting. This program relies on classic behavioral therapy strategies, self-regulation     theory, and provides the support needed for patient/family self-management of weight loss.     Implementing this program in the primary care setting will increase our ability to deliver     nutrition and weight-related counseling in the primary care office and serve patients closer     to home, thereby increasing access to effective treatment, improving adherence to recommended     changes, and meeting the goals of Healthy People 2020.   "
23623|NCT02976441|"     The investigators hypothesize that this study will show that sufficient lymphocyte stem cell     can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5     of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300     cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.   "
23685|NCT02975635|"     Partially defective dental restorations might either be treated by complete replacement or by     repair of the affected region. Repair restorations are a scientifically proven approach to     manage failed restorations, but probably unknown to most patients. Results from this study     and findings on the predictors of patients' therapy decisions might improve future patient     information documents.   "
23624|NCT02976428|"     To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and     proper implant position are very important during the surgical procedure. Soft tissues are     structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and     cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning     may result in knee stiffness, pain, instability and limited range of motion (ROM). This may     result in implant failure and the need for revision surgery. As part of standard practice     orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to     achieve optimal knee balance. New sensor-assisted technology can provide surgeons with     measurable information to help achieve soft tissue balancing, providing surgeons with     immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the     sensor, gives surgeons electronic information on soft tissue balance and implant position.The     purpose of this study is to determine if a sensor guided soft tissue balancing device     (Verasense) is more effective at balancing the knee during surgery as compared to standard     soft tissue balancing performed with a manual balancer device.   "
23625|NCT02976415|"     The purpose of this study is to determine if in-bed cycling is safe and feasible in     critically-ill patients after open heart surgery. The investigators hypothesize that in-bed     cycling can be safely used with this population and that it is feasible to use in a     fast-paced cardiac intensive care unit.   "
23626|NCT02976402|"     The present phase I trial evaluates the feasibility of a postoperative stereotactic     hypofractionated external beam radiation therapy delivered in patients who underwent radical     prostatectomy with adverse pathological features or early biochemical failure. Modern     computer-driven technology enables the implementation of ultra-high hypofractionated     Image-Guided Radiotherapy (IGRT) safely.      Eligible patients for this study are those with:        -  Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical          prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically          assisted; there is no time limit for the date of radical prostatectomy)        -  Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle          involvement        -  Undetectable post-radical prostatectomy PSA that becomes detectable and then increases          on 2 subsequent measurements (PSA of > 0.1 - ≤ 2.0 ng/mL)        -  Life expectancy: 10 years        -  ECOG performance status of 0 -1        -  No distant metastases, based on the following workup within 60 days prior to          registration        -  Magnetic resonance imaging (MRI) of the pelvis        -  PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients          with biochemical recurrence        -  Patients can be on androgen deprivation therapy        -  Ability to understand and willingness to sign a study-specific informed consent prior to          study.      Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc     radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance     procedures with emphasis on normal tissue sparing and delivery accuracy via the use of     devices that ensure stability and beam location reproducibility.   "
23627|NCT02976389|"     The specific aims of this proposal are to implement SCNIP in 6 Northgate Gonzalez Markets     across San Diego, Orange and LA counties (2 in each county), and determine which level of     financial incentive rebate (specifically, $10/month, $20/month, or $40/month) optimally     increases the purchase and consumption of SNAP eligible fruits and vegetables.   "
23628|NCT02976376|"     Study to investigate whether a smart technology intervention can improve clinical and     cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial     infarction.   "
23629|NCT02976363|"     Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP)     after exposure to breast radiation therapy in women. Methods: Prospective observational study     performed at the Hospital de cancer Alfred in Campo Grande/MS. The sample of this study     consisted of women (N = 16) divided into two groups: women exposed to breast radiotherapy     after underwent quadrantectomy surgery (n = 8); and women with no history of cancer (n = 8).     We evaluated the strength of respiratory muscles through the Maximal Inspiratory Pressure     (MIP) and Maximal Expiratory Pressure (MEP) using the handset called manovacuometer. The     examination was performed before the first session and after the twenty-fifth session related     to the last day of the radiation treatment; evaluation of anthropometric data of weight and     height to detect the body mass index (BMI); evaluation of clinical respiratory symptoms of     dyspnea using the Medical Research Council (MRC) Dyspnea Scale and characterization of cough     with Common Pulmonary Toxicity Criteria, in the classification of clinical pneumonitis.   "
23631|NCT02976337|"     Recent studies have focused on the role of endogenous opioids on central sensitization.     Central sensitization is known to be impaired or altered in chronic pain conditions, as     fibromyalgia or chronic tension headache.      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone     administration after resolution of an injury. This suggests latent sensitization. In the     present study, the investigators hypothesize that a high-dose target-controlled naloxone     infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a     unilateral primary open groin hernia repair procedure. The investigators aim to show that     latent sensitization is present in humans and is modulated by endogenous opioids.   "
23632|NCT02976324|"     This study evaluates the effect of external diaphragmatic pacemaker on the patients with     chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker,     while the other half will receive routine therapy.   "
23633|NCT02976311|"     In this study, the investigators aimed to find out whether there are any differences in     inflammatory reactions occured subsequent to two different cesarean delivery techniques;     modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.   "
23686|NCT02975622|"     Ultrasound (US)-guided central venous catheterization is now considered standard of care     according to recent clinical evidence, at least considering jugular vein approach. Recent     trials suggested that even US-guided subclavian approach could be more effective that     landmark technique. However, studies comparing both sites employing US are still lacking.      We, therefore, designed a non-inferiority randomized controlled trial to compare these sites,     both using US guidance, according to immediate complications following central venous     catheterization.   "
23634|NCT02976298|"     In human, the physiology of gait and balance is not clearly established. By using functional     imaging and electrophysiological techniques, various brain regions from the cortex to the     midbrain area, including the cerebellum, have been identified as involved in such control.     The specific role of these structures in both the capacity to go forward (locomotion) and     stand upright (balance), but also in the different phases of the gait initiation process, are     not known, however. In this study,the investigators aimed to assess the specific role of both     the supplementary motor area (SMA) and the cerebellum in postural control during the     initiation of gait. For this purpose, the investigators plan to study the gait initiation in     20 healthy subjects before and after functional inactivation (using inhibitory repetitive     transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic     and electromyographic parameters of the gait initiation will be recorded using a force     platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG     electrodes.   "
23635|NCT02976285|"     The purpose of this study was to assess the impact and potential advantage of a novel     synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and     radiological approaches. The investigators hypothesized that implanting this patch will     improve individual shoulder function, while reducing re-tear rates compared to the current     literature.   "
23636|NCT02976272|"     Chemotherapy-induced peripheral neuropathies (CIPN) remain a problem in oncology because no     gold standard treatment exists to prevent or treat the CIPN. Therefore, oncologists reduce     or stop the chemotherapy doses to limit degradation of the quality of life of patients with     CIPN. Bortezomib is relatively understudied while neurotoxicity remains a limiting factor for     treatment. Since 2012, the FDA and the EMA validated by the administration of bortezomib     subcutaneously (SC) instead of intravenous (IV) in order to limit neurotoxicity.      However, a retrospective study reported that the prevalence of neuropathy induced by     bortezomib after SC administration remains high and equivalent to IV route. No studies have     quantitatively and qualitatively evaluated the sensory disorders in peripheral neuropathies     induced by bortezomib after SC administration. On the other hand, the QLQ-CIPN20     questionnaire (EORTC) evaluating the intensity of sensory, motor and autonomic disorders     associated with CIPN has never been tested in this population. The objective of this study is     twofold: (i) psychophysical evaluation of neuropathic disorders by studying the thermal and     vibratory detection thresholds and thermal nociceptive thresholds and (ii) quantitative and     qualitative assessment of neuropathic disorders by the QLQ-CIPN20 and related comorbidities     in a population of neuropathic patients treated with bortezomib (n = 15), compared to control     patients treated with bortezomib but non-neuropathic (n = 45).   "
23637|NCT02976259|"     Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue     Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56      Coordinating investigator:      Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses      1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail :     caroline.lascoux-combe@aphp.fr      Participating country : FRANCE      Primary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal     plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF     (TDF) + emtricitabine (FTC) at the time of PHI.      Secondary objectives :        -  Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal          plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48        -  To assess the frequency of intermittent shedding in seminal plasma once virological          suppression has been achieved and until W48        -  Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48        -  Comparison of dolutegravir concentration in blood plasma and seminal plasma        -  Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma        -  Analysis by deep sequencing of the viral population (quasi-species) in both compartments          (blood plasma and seminal plasma) before virological suppression has been achieved (i.e.          at D0 and W12)      Inclusion criteria :        -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or          indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a          western blot profile compatible with ongoing seroconversion (incomplete western blot          with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative          test for HIV antibodies followed within 3 months by a positive HIV serology        -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245          mg/200 mg) initiated by the referee physician within a maximum of 15 days after          diagnosis of PHI        -  Genotypic sensitivity to TDF, FTC and DTG        -  Patient with medical care insurance      Exclusion criteria :        -  Chronic infection        -  Infection or co-infection with HIV-2      Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients     (exploratory study)   "
23659|NCT02975973|"     Cognitive impairments in schizophrenia are the most debilitating aspect of the illness and     poorly treated by current medications. This study investigates transcranial direct current     stimulation (tDCS) - a safe, noninvasive weak electrical current delivery to stimulate brain     function - as a novel therapeutic for cognition in schizophrenia. Integrating     neurostimulation, electrophysiology and neuroimaging, this project aims to study tDCS effects     on cognition by verifying therapeutic target engagement, evaluating the tolerability of tDCS     sessions, and optimizing treatment parameters.   "
24046|NCT02970916|"     The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or     without ACE polymorphisms in terms of Progression-free survival (PFS).   "
23638|NCT02976246|"     Cardiovascular disease (CVD) is the most frequent cause of death in patients (ptt.) with     chronic kidney disease (CKD). Compared to the general population death due to CVD is 10-20     times higher in CKD ptt. being treated with hemodialysis. Vascular calcification and hence     arterial stiffness is of great importance for the high incidence of CVD.      CKD ptt. in dialysis treatment also have a 3 times higher risk of bone fractures. Both     vertebral and other fractures of low energy are associated with a high mortality.      Matrix Gla Protein (MGP) is an important inhibitor of vascular calcification and Osteocalcin     (OC) is an important regulator of bone metabolism. The function of both MGP and OC depend on     vitamin K.      Vitamin K is supplied with food. The content is low in food recommended to CKD ptt. which is     reflected in very low concentrations of vitamin K in their blood samples. A correlation     between vitamin K level, incidence of vascular calcification and bone density has been     proven; yet there are no trials elucidating the clinical effect of vitamin K on vascular     calcification or bone strength.      The investigators will conduct a randomized placebo controlled trial examining the clinical     effects of vitamin K2 on vascular calcification and bone mineralization in order to prevent     and treat CVD and bone disease in CKD ptt.      Primary study endpoints:        1. Changes in arterial stiffness assessed by pulse wave examination        2. Changes in bone mineral density (BMD) in distal radius assessed by DXA-scans.      Secondary study endpoints:      Changes in coronary artery and valvular calcification assessed by heart-CT-scans, blood     pressure, body composition, total and regional BMD, lateral column/aortic calcification score     as well as a panel of correlating blood tests.   "
23687|NCT02975609|"     This protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of SBRT     compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell Lung     Cancer   "
23688|NCT02975596|"     As part of an effort to increase MenB vaccine uptake among adolescents and young adults,     study teams will conduct qualitative research to maximize the effectiveness of nationally     recommended MenB educational materials. In this study, Study Teams will assess local barriers     to MenB vaccination by conducting focus groups with parents, students, and health care     professionals.   "
23732|NCT02975024|"     Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to     enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes     during wound healing in human subjects.   "
23639|NCT02976233|"     Over the last two decades, non-invasive ventilation (NIV) has been widely reported as an     effective method to avoid the need of endotracheal intubation (ETI) and improve survival in     the acute care setting. Given the risks associated with either premature NIV discontinuation     or delays in NIV interruption, evaluating readiness to weaning from NIV is a critical     challenge in patients with Acute Respiratory Failure (ARF).      Up to date, bedside measurements used to predict NIV outcomes are extremely limited. NIV     weaning as well as decision of ETI are mainly supported by clinical and physiologic     parameters. More sophisticated techniques used to predict weaning outcome during spontaneous     breathing trials have never achieved a bedside broad-spectrum use due to their invasiveness,     the inconsistent results in demonstrating reproducible outcomes, the requirements of     additional trainee personnel and complicated equipment, and the difficult application in     awake and non-intubated patients.      Recently, ultrasound has been used for the rapid assessment of diaphragm function in acutely     ill patients. The advantages of the ultrasound in detecting diaphragm dysfunction as compared     with other techniques are the less invasiveness, the avoidance of radiation hazards and the     bedside feasibility. Direct imaging of changes in diaphragm thickening (DT) during     spontaneous breathing may provide the assessment of both the muscle and the respiratory pump     functioning. Indeed, DT has been correlated with the diaphragm strength and the muscle     shortening. The volume of diaphragm muscle mass remains constant while it contracts.     Consequently, as the muscle shortens it thickens itself and measurements of changes in such a     thickening (DT) are inversely related to changes in diaphragm length. Studies in patients     with diaphragm paralysis have confirmed the absence of DT. Moreover, since the diaphragm is     the major muscle of inspiration, the presence of diaphragm shortening and contraction may     predict successful extubation in patients who are invasively ventilated.      The aim of the present study is to assess whether DT as measured by ultrasound may predict     NIV outcome in patients with de-novo ARF admitted to the Emergency Department (ED).   "
23640|NCT02976220|"     This study is designed to evaluate the feasibility of using digital-enabled education in     clinical care in order to improve patient outcomes related to end-stage renal disease (ESRD).     If effective, educational interventions could be used to improve the long-term survival of     patients with chronic kidney disease (CKD) and to make clinical care for these patients more     cost effective.   "
23641|NCT02976207|"     Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical     treatment   "
23642|NCT02976194|"     Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be     measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of     ranibizumab.   "
23643|NCT02976181|"     Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that     lack of awareness of treatment and diagnostics pathways result in lower number of referrals     to implanters of IPG.   "
23644|NCT02976168|"     The aim of the study is to understand the relationship between intracranial pressure     regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the     study tests the hypothesis that head down tilt will increase intracranial pressure (not     measured in this study, but demonstrated in previous studies), will induce venous congestion     and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning.     The objectives of the study therefore are to assess young healthy people during head-down     tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation     (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via     event-related potentials.   "
23645|NCT02976155|"     The goal of this study is to evaluate whether a standard enteral nutrition protocol can     improve the efficiency in achieving nutritional goals and improve prognosis in critically ill     patients.   "
23646|NCT02976142|"     The purpose of this study is to determine whether intraperitoneal immunotherapy (with     interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more     effective than systemic chemotherapy alone in patients with gastric cancer and verified free     cancer cells in abdominal cavity in improving the long term outcomes and overall survival of     further surgical treatment.   "
23647|NCT02976129|"     The purpose of this study is to evaluate the efficacy and safety of V565 in participants with     active Crohn's Disease.   "
23648|NCT02976116|"     Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced     non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm,     multicenter, phase II study   "
45300|NCT02692703|"     The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of     ABT-493/ABT-530 in adults who are post primary orthotopic liver or renal transplant with     chronic Hepatitis C Virus infection.   "
23650|NCT02976090|"     Despite the fact that small intestine makes up 75% of the length of the digestive tract and     90% of its mucosal surface area, small bowel adenocarcinoma (SBA) is rare. SBA is not equally     dispatched along the small bowel, a predisposing disease is frequently associated. All these     data suggest particular carcinogenesis pathway. SBA carries poor prognosis at all stages and     no standard treatment have proved efficacy. So far, no data are available for targeted     therapy. From the literature and a previous study of our group some biologic data showed that     SBA carcinogenesis is closer to colorectal than gastric carcinogenesis. Nevertheless, some     differences arise (ie: low Adenomatous Polyposis Coli mutation rate or frequent DNA mismatch     repair deficiency). Even if some trends are founded the prognostic value of molecular     alteration and phenotype variation according to small bowel segment, or predisposing disease     could not been demonstrate due to small sample size.      BIONADEGE study is a planned biologic ancillary study of the NADEGE cohort that enrolled 366     patients with SBA from 2009 to 2012 in France. The tumour blocks and clinical data of 187     patients have been collected. The main objective is to assess the prognostic value for     recurrence free survival (RFS) in non-metastatic patients and overall survival (OS) in     metastatic patients of molecular alteration in a set of 46 genes and abnormal protein     expression potentially implicated in carcinogenesis. The mains secondary objectives are: 1)     to identify potential mutation targetable in small intestine tumours and protein expression,     2) to state the frequency of molecular alteration according to the tumour location, stage or     predisposing disease and established clinico-biologic correlation. Tissue microarrays will be     performed and several potential prognostic markers will be assessed. Sequencing on tumour DNA     will investigate the presence of 740 hot spot somatic mutations in 46 genes involved.The     abnormal protein expression or the genetic alterations with an expected frequency superior to     10% will be assessed as potential prognostic factor to RFS and OS.      These evaluations on a large cohort could allow comparison between pathways and will offer     better knowledge of tumour molecular phenotype and prognosis will give rational for targeted     therapy trials The predisposing diseases for SBA involved several different carcinogenesis     pathways. Finally, a molecular classification of SBA will be attempt.   "
23698|NCT02975466|"     A can't intubate, can't oxygenate situation is life-threatening and the physician must be     prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is     associated with complications. In both of these situation and as recommend by different     societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an     intubation conduit to ease the airway access. The objective of this randomized controlled     trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the     fastest intubation time in an adult population, with the objective of minimizing     complications related to these situations. The investigators will conduct a three-arm trial     to compare different outcomes related to the installation of the SGA and its use as an     intubation conduit. The results of this trial will inform the anesthesiologist on which     device to use on to have close in case of airway emergencies.   "
23651|NCT02976077|"     Background:      Difficulties in social interactions are a central characteristic of people with     schizophrenia, and can be partly explained by impairments of social cognitive processes.     According to renown researchers, three to five social cognitive processes are usually altered     in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional     style; and (4 and 5) social perception and knowledge. The components of social cognition     appear to be related to both symptomatology and functioning in everyday life.      New strategies of cognitive remediation have been recently developed to target these deficits     and few meta analyses have assessed the extent to which social cognitive remediation programs     have led to multiple improvements for schizophrenia patients. Overall, it seems that such     therapies showed encouraging results in both patient interest and motivation, and social     cognitive processes.      The RC2S therapy is the first individualized and partly computerized program through which     patients practice social interactions and develop social cognitive abilities with simulation     techniques in a realistic environment.   "
23652|NCT02976064|"     Background: The growing awareness on the health burden generated by insufficient levels of     physical activity has prompted the interest for deploying community-based initiatives aiming     at fostering active healthy living. It is of note, however, that, to our knowledge, none of     the interventions evaluated so far have reached large scale adoption. The current protocol     relies on the general hypothesis that properly tailored self-management programs, fully     integrated in the patient's action plan with remote off-line professional support, may induce     sustained behavioral changes resulting in exercise health behavior. Accordingly, the current     manuscript addresses those unmet requirements, namely: i) Workflow design of the PA services     engaging both patients and health professionals; ii) Enhanced information and communication     technologies (ICT)-support; iii) Evaluation strategies including structured indicators; and,     iv) Implementation of innovative business models. The main outcome of the current protocol     will be a roadmap for large scale deployment and assessment of novel collaborative     self-management PA services in the region of Catalonia (7.5 million citizens).      Methods: The protocol has been designed as part of the regional deployment of integrated care     services in Catalonia (2016-2020). It has been conceived has a two-year (2017-2018) test bed     period.      Aims: The protocol uses a population-health approach to addresses the four aims: i)     Prehabilitation for high risk candidates to major surgery; ii) Community-based rehabilitation     for clinical stable chronic patients with moderate to severe disease; and, iii) Promotion of     physical activity and healthy lifestyles for citizens at risk and patients with mild disease.   "
23653|NCT02976051|"     Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET     scanning   "
23654|NCT02976038|"     This is a Phase 2 Open-Label extension study to evaluate the long term safety and     tolerability of daily elamipretide injections in patients with genetically confirmed Primary     Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial   "
23655|NCT02976025|"     This study evaluates the impact of a longitudinal remote consultation (LRC) implementation     strategy for collaborative care depression treatment among perinatal women receiving care     from federally qualified health centers (FQHCs). All participating FQHCs will receive     training in collaborative care. Cluster randomization will be used to assign the addition of     LRC to select FQHCs. Differences in implementation success, clinical outcomes, and costs will     be compared after a 12 month implementation period and 13-21 month sustainment period.   "
23656|NCT02976012|"     This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will     receive one preoperative intravitreal aflibercept injection (IAI) <21 days but >7 days prior     to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1     ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI     for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by     mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).   "
23657|NCT02975999|"     The purpose of this study is to determine whether Vasopressin following the Fontan operation     will decrease chest tube output and duration.   "
23660|NCT02975960|"     Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and     visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the     treatment for these manifestations are often ineffective.      Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem     cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and     tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.      There are only few ways to manage SSc patients with skin lesion who already have treated with     several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist)     but some times their skin lesions are critical physically and emotionally.      Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc.     Thus, the investigators study the efficacy and potential adverse event in Korean patients     with SSc.   "
23699|NCT02975453|"     Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial     fibrillation (NVAF) patients treated with rivaroxaban in Spain   "
23700|NCT02975440|"     This study will be conducted in a single center, open-label study with a single group fixed     sequence design to evaluate the effect of repeated oral administration of 600 mg     RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of     VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.   "
23661|NCT02975947|"     The operating theatre is deliberately made to be cold and dry to prevent bacteria from     growing. The problem with this is that during open abdominal surgery, the intestine and the     overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum     from drying by applying warmed saline packs periodically to the bowel. However, this is not     always possible. Sometimes, the surgeon has to perform an important component of the     procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries.     When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum     causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel     obstruction. This vicious cycle is repeated when the patient undergoes repetitive open     abdominal operations.      This study aimed to be the first human study to:        1. Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also          to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated          during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is          increased for pro-inflammatory cytokines. This study also aim to show that          proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using          Western Blotting) are elevated during the course of the operation.        2. Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to          the bowel/peritoneum drying (dessication).      This study will attempt to prove this by using humidified, warmed carbon dioxide gas which     will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the     peritoneal injury and the inflammation. The investigators will attain peritoneal samples     during open colorectal operations. The investigators will obtain samples at the beginning and     end of the operation. This study design is a randomized controlled trial, where half the     patients will receive humidified, warmed carbon dioxide gas during surgery, and the other     half will get standard open surgery without carbon dioxide. 40 patients will be recruited in     this study. Half (20) will get CO2, and other half (20) will get standard open surgery.   "
23662|NCT02975934|"     The purpose of this study is to determine how patients with metastatic castration-resistant     prostate cancer, and evidence of a homologous recombination gene deficiency, respond to     treatment with rucaparib verses treatment with physician's choice of abiraterone acetate,     enzalutamide, or docetaxel.   "
23663|NCT02975921|"     The purpose of this study is to determine whether betadine (povidone-iodine) instillation     during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in     promoting pleurodesis and thus reducing the time to TPC removal.   "
23664|NCT02975908|"     ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The     mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion     has been put forward. Yet, its feasibility, reliability and validity need to be tested.     Meanwhile, the correlation of different severity and prognosis remains unclear. As so far,     the epidemiological information about ARDS in China is lacking.      Investigators plan to conduct a multi-center observational study（real-life study） to     investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order     to facilitate standardization of diagnosis and management of ARDS and provide basic data and     idea for further clinical intervention studies.   "
23665|NCT02975895|"     Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual     acuity. In most cases it can be managed with surgery, removing the own lens and replacing it     with an artificial lens, intraocular lens (IOL). These lenses are made in different materials     with different properties.      Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this     disease have an increased risk of developing cataract due to the inflammation itself and     treatment with steroids. They also have an increased risk of complications during surgery and     postoperatively. In this group the selection of IOL might be of greater importance.      The aim of this prospective randomized controlled study is to compare the outcome of     hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis   "
23666|NCT02975882|"     This phase I trial studies the side effects and best dose of nanoparticle albumin-bound     rapamycin when given together with temozolomide and irinotecan hydrochloride in treating     pediatric patients with solid tumors that have come back after a period of time during which     the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound     rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving nanoparticle albumin-bound     rapamycin, temozolomide, and irinotecan hydrochloride may work better in treating pediatric     patients with solid tumors.   "
23667|NCT02975869|"     This research study is evaluating the impact a collaborative palliative care and oncology     team will have on the quality of life, symptoms, mood, and end of life outcomes of patients     with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on     lessening (or palliating) symptoms and assisting in coping with serious illness.   "
23668|NCT02975856|"     The main aim of this study is to evaluate the bioavailability of table red wine and young     Port red wine anthocyanins in healthy men.   "
23669|NCT02975843|"     The purpose of this study is to investigate the lung deposition and distribution pattern of     Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a     Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF     5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.   "
24058|NCT02970747|"     The objective of this non-interventional study (NIS) is to evaluate patients' adherence and     persistence to carfilzomib therapy in combination with lenalidomide and dexamethasone or     dexamethasone alone in adult patients with multiple myeloma (MM) who have received at least     one prior therapy in a real-life setting.   "
23670|NCT02975830|"     Accurate understanding of tracheobronchial anatomy is important for application of various     airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks     state that the anatomic orientation of the right main bronchus is at less acute angle to the     vertical tracheal axis, although these angles tend to be similar in children younger than     three years of ageThe visualization of the air column in tracheobronchial tree in a     three-dimensional (3D) CT-based image is clear with the air column simulating the actual     internal shape of the airway.      We hypothesize that RBA and LBA are unequal as children like adults are prone to right     mainstem intubation We have measured the right and left bronchial angle using the three     dimensional CT based images of the air column in the tracheobronchial tree.   "
23671|NCT02975817|"     The investigators wish to undertake a randomized controlled non-inferiority trial to evaluate     the ability of a simple and low-cost method (Hibler´s method of wrapping the patient in     multiple insulating layers) to prevent intraoperative heat-loss in children undergoing     neurosurgery under anesthesia in Malawi. The control group will be heated actively with the     use of warm-air blankets. The aim of this study is to evaluate whether Hibler´s method can     provide a cheap and technically simple way of adequately preserving the patients´ core     temperature in the operating theatre in a resource-poor setting.   "
23701|NCT02975427|"     Prospective, single arm, dietary intervention study.   "
23702|NCT02975414|"     The purpose of this study is the measurement of the evolution of the operation time during     the start-up phase of robotic assisted surgery for the treatment of incisional hernia`s of 40     patients treated in Maria Middelares in laparoscopic rTARUP technique.   "
23672|NCT02975804|"     Objectives:      This proposal is to investigate the effect of a 6-week training programme using an     Interactive computer play (ICP) on the trunk control, balance and gross motor function in     children with cerebral palsy (CP).      Hypothesis to be tested:      The trunk control, balance and gross motor function of children with CP will be significantly     improved after the ICP programme.      Design and subjects:      20 children (6 to 12 years old) with CP will be recruited in this pilot randomised controlled     trial. The children will be randomly allocated into a control or treatment group (10 children     in each arm).      Study instruments:      Tymo is a wireless force plate used for assessment and training.      Intervention:      An ICP program will be set up using the Tymo. The child uses their trunk movements in the ICP     in sitting during the intervention. The children will receive the intervention 4 times/week,     20 minutes/session for 6 weeks. All children will be assessed at the beginning, 3, 6 and 12     weeks post-intervention.      Main outcome measures:        -  Segmental Assessment on Trunk control        -  Pediatric Reach Test        -  Gross Motor Function Measure 88 (GMFM 88)        -  2-minute walk test      Data analysis:      As a pilot study, 20 children will be recruited for this study. Independent t-test or Mann     Whitney U test will be used to compare the continuous and ordinal results between the     intervention and control groups.      Expected results:      The trunk control, balance and gross motor function of children with CP will be significantly     improved after the intervention.      Clinical significance and potential of the study:      This is clinical trial to examine the effectiveness of a new intervention, a kind of     interactive computer play training module, on training the trunk control for children with     cerebral palsy. If the intervention is proven effective, it may be an adjunct to the     conventional Physiotherapy to children with movement disorders in enhancing their trunk     control. Better trunk control will in turn improve the daily function for these children as     their sitting and standing balance is improved. In a long run, these children will not rely     on expensive seating equipment to maintain their balance during schooling and at home.   "
23673|NCT02975791|"     After a structured teaching program anaesthetists are educated in identifying the     cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared     with their ability to do so with palpation. In an obese volunteer   "
23674|NCT02975778|"     The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and     simple of employment, for old people able to answer to a digital scale of pain intensity.      The main objective is to develop and to validate a model of prediction of the pain in old     subject at the time of the care, using the measure of variation of the skin conductance.   "
23675|NCT02975765|"     Applying flapless piezocision corticotomies on the alveolar bone and separating anterior     mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very     accurate incisions without any sutures following this procedure) may improve the speed of     tooth alignment during orthodontic treatment. This study consists of two groups, patients     will be randomly assigned to one of these two groups. The levels of pain and discomfort of     this procedure on 18 patients (experimental group) will be evaluated,whereas the second group     (control group) will receive a traditional orthodontic therapy.   "
23676|NCT02975752|"     First-line treatment with afatinib prolongs overall survival in patients with metastatic     non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,     somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In     this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19     and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).   "
23677|NCT02975739|"     The main objective is to establish the feasibility of 166-Holmium microspheres for     intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.      Participants will receive intratumoral injections with a low radioactive 166-Holmium     microspheres followed by surgical resection   "
23678|NCT02975726|"     One complication of liver disease is the buildup of fluid within the belly. This is known as     ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of     breath. Ascites is typically treated with medications, however when that does not work,     patients need a procedure where a needle is inserted in the belly every few weeks to drain     the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney     disease from their worsening liver function or from the drainage of fluid with needles. Once     patients have both advanced liver disease and kidney disease, their chance of dying largely     increases.      The present study will be the first of its kind to study a new technique to treat ascites.     Investigators are planning to place a tube in a patient's belly to drain the excessive     amounts of fluid. This technique is similar to how one type of dialysis is done to treat     patients with kidney failure. This study is set as a pilot investigation in order to     determine the feasibility of doing a larger, randomized clinical trial investigating the use     of this novel technique. Importantly, advanced liver disease patients are at high risk to     develop kidney disease, and therefore are an important group to focus on. Investigators     believe that this technique will prevent or slow the development of kidney disease in liver     failure patients, and improve their quality of life, far more than the current available     treatments.   "
23679|NCT02975713|"     To evaluate the influence of circadian rhythm on progesterone levels during follicular phase     of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.   "
23680|NCT02975700|"     The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary     efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic     KIT-mutated melanoma.   "
23681|NCT02975687|"     In this single-center, open-label, no control, prospective clinical trial, a total of 20     resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be     enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a split dose     (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on     day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19     CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.   "
23682|NCT02975674|"     The trial is designed as a consecutive enrollment prospective one-center study. A minimum of     30 patients will be included in the study. At implant installation, the patient will be     randomized to receive one of the two types of implants (Control: internal hexagon connection     implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant     crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage     surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12     months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks     after the impressions are taken.   "
23683|NCT02975661|"     Registration of patients after gastrointestinal cancer radical surgery, including the     information of treatments, recurrence & metastasis, adverse events,etc.   "
23684|NCT02975648|"     The purpose of this study is to compare the effect of an educational model, which includes     cardiac rehabilitation with emphasis on physical activity and telephone reinforcement, with     the usual management of individuals undergoing to intervention coronary percutaneous, in     relation to physical activity six months after discharge.   "
23689|NCT02975583|"     There are no medical therapies indicated for reduction of limb ischemic events. Studies of     dual-antiplatelet therapy with aspirin and clopidogrel versus aspirin alone (CASPAR) as well     as studies of systemic anticoagulation (WAVE) have shown no benefit for either strategy in     the reduction in limb vascular events. Surgical bypass grafting involves harvesting of the     vein, warm ischemia with disruption of vaso vasorum, ischemia-reperfusion, and finally     heightened hemodynamic stress in the new arterial environment. Vein grafts rapidly remodel in     response to the increase in blood flow and pressure in an attempt to normalize them into     physiological range. The investigators have previously identified 3 distinct temporal phases     of the remodeling process: During the first 30 days following implantation is a critical     period of luminal enlargement which appears to be an endothelium-independent process. The     second phase occurs between 1 and 3 months and represents a period of stiffening of the vein     graft indicating synthesis of fibrous proteins. The third period is referred to as     biochemical remodeling wherein the vein recovers clinically measureable endothelial function.     It is likely diabetes mellitus impacts each of these phases. TRA2°P-TIMI 50 demonstrated a     reduction in acute limb ischemic (ALI) events (42% reduction) and urgent peripheral arterial     revascularizations (35% reduction), a finding unique among medical therapies. While the     temporal trend in reduction in ALI events occurred early and late after exposure suggestion     an antithrombotic mechanism, the reduction in elective revascularization occurred later     suggested beneficial effects beyond platelet inhibition. The purpose of this trial is to     study the physiological impact of vorapaxar on lower extremity bypass graft maturation and     function.   "
23690|NCT02975570|"     The proposed study will randomize adults (18 years of age or older) with pulmonary MDR-TB     with sputum that contains M. tuberculosis that is isoniazid and rifampin resistant by     MTBDRplus and fluoroquinolone susceptible by MTBDRsl HIV seropositive (with or without     antiretroviral therapy) or negative (but not unknown) and Karnofsky score of >60 at sites in     Moldova, Peru, and the Philippines.      Patients with MDR-TB will be randomized to oral regimen of delamanid (DLM), linezolid (LZD),     levofloxacin (LFX) and pyrazinamide (PZA) for 24, 32, 40, 48 or 56 weeks or World Health     Organization (WHO) standard of care MDR-TB regimen (9-month modified Bangladesh regimen or     WHO standard MDR-TB regimen).      Primary Objective      1. Determine the shortest duration of the delamanid-containing oral regimen that is     non-inferior to the blended WHO standard regimen.      Secondary Objective        1. Define the safety and tolerability of the oral delamanid, linezolid, levofloxacin and          pyrazinamide regimen.        2. Determine if baseline PZA susceptibility is associated with shorter time to non-inferior          treatment duration.        3. Identify the relationship between delamanid and linezolid serum drug levels and time to          sputum culture conversion among patients on the delamanid-containing oral regimen.        4. Identify the relationship between delamanid and linezolid serum drug levels and          occurrence of adverse events among patients on the delamanid-containing oral regimen.   "
23691|NCT02975557|"     The objective of this study is to establish whether patients with dry eye disease (DED) are     able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks     (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine     0.15% topical eye drop solution in treating MGD (primary efficacy objective).      Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's     syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome     of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.   "
23692|NCT02975544|"     The purpose of this study was to evaluate whether an intervention based on the social and     emotional competence development improves the healthy lifestyles adoption in young children.   "
23693|NCT02975531|"     Parameterize the Pompage technique with an anatomical model cervical region to simulate     specific procedures. Quantify the times, displacements, and facilitate the training of     students and professional of physical therapy.   "
23694|NCT02975518|"     We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in     the context of vascular injury sustained during elective coronary angiography.      We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.   "
23695|NCT02975505|"     The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a     vulnerable and challenging period of time for patients and providers. Suboptimal control of     blood pressure is known to be common in patients with the advanced stages of CKD, and may     contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and     mortality. This proposal is a pilot randomized controlled trial designed to test whether     intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they     transition to ESRD.   "
23696|NCT02975492|"     Recommendations for vitamin D supplementation for children between 2 and 6 years offer strong     sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months.     Data from the literature show a further increase in the incidence of oxalo-calcium stones in     children and adolescents associated with hypercalciuria with training Randall plates,     essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary     calcium excretion, these data lead to the question of increased sensitivity in some children     with vitamin D, sensitivity could explain these situations with hypercalciuria increase the     gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of     high doses of vitamin responsible then a transient hypercalciuria with development of     microcrystals.   "
23697|NCT02975479|"     The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy     in increasing doses. Patients with allergy to grass or birch will be treated with three     intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or     placebo.      ***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000     SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One     patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic     injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New     regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.   "
23703|NCT02975401|"     The purpose of this study is the measurement of the evolution of the operation time during     the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia`s of 50     patients treated in Maria Middelares in laparoscopic rTAPP technique.   "
23706|NCT02975362|"     The objective of this proposed study is to determine whether acupuncture combined with     rehabilitation treatment could improve significantly motor function in ischemic stroke     patients. In this 8-week, assessor-blind, a Multi-center randomized, controlled study of     acupuncture as additional treatment with the rehabilitation treatment, a total of 240     patients with stroke patients will be recruited. The patients will be randomly assigned to     acupuncture combined with rehabilitation treatment (n =120) or rehabilitation treatment (n     =120). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured     using Fugl-Meyer Scale and Modified Barthel Index. Change in the stroke syndromes over time     are measured using stroke syndrome of TCM Scale. Change in the quality of life over time are     measured using SS-QOL scale. The study will be conducted at Shanghai University of     Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.   "
23707|NCT02975349|"     The aim of this protocol is to find out about the safety and effectiveness of M2951 in     patients with relapsing multiple sclerosis. Patients will be placed into 1 of 3 groups to     receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the patients on placebo     will be given M2951.   "
23708|NCT02975336|"     M2951 is an investigational drug under evaluation for treatment of autoimmune and     inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of     M2951 in Subjects with Systemic Lupus Erythematosus (SLE)   "
23709|NCT02975323|"     Portal hypertension is the result of an increased hepatic vascular resistance and portal     inflow. The best established method to assess portal pressures is the determination of wedged     hepatic venous pressure gradient (HVPG). Ultrasound Doppler technique is non-invasive in the     assessment of portal hypertension as compared with invasive technique of measurement of the     hepatic venous pressure gradient (HVPG). Hemodynamic measurements (BP and pulse recording)     will be done and then patient will be given tablet Carvedilol 12.5 mg in a single dose and     wait till the time that 20% reduction in heart rate from the baseline occurs. Haemodynamic     measurements will be repeated to assess the acute response to beta-adrenoreceptor blocker     agent. The change in the HWF will be recorded post beta-adrenoreceptor blocker     administration.   "
23710|NCT02975310|"     Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease     affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and     headache, an inability to breath through the nose and complete smell loss, regularly impair     one's ability to work and to enjoy and participate in daily activities. The annual cost of     chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an     estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps,     the most common type of chronic sinusitis, is usually treated with a combination of     medications and surgery. Until now, surgical treatment has only been performed in the     operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a     new procedure, in-clinic polyp removal, can provide an improvement in patient symptoms to     levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in     clinic polyp removal has additional advantages including a shorter procedure recovery time, a     significantly lower cost to the health care system (about one-tenth the cost or $450), and a     shorter wait time for treatment. With the proposed pragmatic trial, the investigators will     determine whether the in clinic polyp removal procedure is as good as sinus surgery in the     operating room at controlling patient symptoms of chronic sinusitis. The investigators will     also determine the cost and health-benefits for a patient, the healthcare system and for     society of in clinic polyp removal in comparison to sinus surgery done in a hospital     operating room. The investigators will then know if this new treatment, in clinic polyp     removal, can replace sinus surgery as the standard of care for these patients.   "
23711|NCT02975297|"     The purpose of this study is to identify a potential new treatment for smoking cessation.   "
23712|NCT02975284|"     This study evaluates the longterm clinical outcomes, including safety and efficacy parameters     after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included     in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension     study.   "
23713|NCT02975271|"     Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn     Injury   "
23714|NCT02975258|"     The goals of this study are to 1) examine the relationships among inflammation, obesity, and     asthma in people with HIV and 2) to test if special subtypes of cells or markers are present     in the blood and lungs of people with HIV with asthma compared to those without asthma.   "
23715|NCT02975245|"     This study will determine the short-term effects of chemotherapy on sperm DNA.The study     involves the collection of semen sample through ejaculation prior to initiation of     chemotherapy and up to three time points after initiation of chemotherapy.   "
23716|NCT02975232|"     Through research, education and extension, this project will promote fruit and vegetable     (F&V) purchases and consumption by families in under-resourced communities, thus reducing     health disparities, improving human nutrition, and preventing unhealthy weight gain among     children. Specifically, this project aims to evaluate the success of promoting F&V purchases     among low- income and Supplemental Nutrition Assistance Program (SNAP)-eligible families and     children living in a rural Maine community through a double value coupon, supermarket- based     incentive program combined with Cooking Matters at the Store education. Education and     extension efforts based on the study findings will contribute to meeting USDA Childhood     Obesity Prevention Challenge Area Goals of generating new knowledge; developing, assessing     and expanding effective interventions; and increasing the number of skilled and informed     professionals and consumers to address the complex problem of childhood obesity. The research     team will partner with a large national retail grocery chain (Hannaford Brothers), Cooking     Matters, University of Maine Cooperative Extension, eXtension Communities of Practice, Maine     SNAP-Ed, and The Food Trust to accomplish the project objectives.   "
23717|NCT02975219|"     Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the     need for repeated surgery, with considerable associated morbidity. The aim of this pilot     project is to determine the feasibility of fluorescence imaging to improve the treatment of     endometriosis in the future.   "
23718|NCT02975206|"     Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic     Dermatitis   "
23719|NCT02975193|"     Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor     outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now     an evidence-based treatment for certain cases of PD, has the risk of causing deficits in     multiple areas of cognition.      As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic     basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by     measuring brain signal activity while PD patients are engaged in cognition on a computer.   "
23720|NCT02975180|"     Every year about 1 out of every 1,600-5,000 infants has a stroke around the time of birth.     Many of these children will have lifelong physical problems. For example, the arm muscles are     often paralyzed. This makes every day activities, like reaching and grasping objects, very     difficult. To date there are few effective treatments for the paralyzed arm of young children     with stroke. The main objective of this study is to test whether a new kind of treatment,     known as functional electrical stimulation (FES), is able to improve arm function in children     with stroke. FES involves applying electrical currents to weak or paralyzed muscles. This     enables movements, such as reaching and grasping, which can then be practiced. The     investigators will compare the effectiveness of FES treatment to standard arm rehabilitation     in children aged 3-6 years who had a stroke early in life. They will measure the     effectiveness using a number of clinical measures of arm function. Other objectives of this     project are to test how well children adhere to the treatment schedule, and to evaluate     parent and child satisfaction with FES treatment.   "
23721|NCT02975167|"     Labor induction is one of the most common obstetric procedures performed in the U.S. In 2012,     the last year for which data is available, 23.7% of all deliveries were the result of     inductions. Labor induction first requires cervical ripening, which can be accomplished by     several different methods. Vaginal or oral prostaglandins, extra amniotic saline infusion,     osmotic dilators and transcervical Foley catheters are all widely used instruments for     pre-induction cervical ripening. The ideal cervical ripening tool is safe for both mother and     fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal     discomfort. The Foley catheter has been found to be both safe and effective, but little is     known about patient satisfaction with the device in an in-patient and out-patient setting.     The proposed study will investigate patient satisfaction in a randomized controlled trial of     in-patient versus out-patient use of Foley catheters.   "
23722|NCT02975154|"     This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of     the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive     Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment     with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control     group without specific interventions.   "
23723|NCT02975141|"     This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination     with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.     The identified MTD will serve as recommended phase II dose (RP2D).   "
23724|NCT02975128|"     This study will assess whether it is feasible to remove small breast cancers completely using     the Breast Lesion Excision System under Ultrasound guidance.   "
23725|NCT02975115|"     This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a     complete molecular response and to prove a possibility of Operational Cure in CMR patients.   "
23726|NCT02975102|"     The primary objectives of this investigation are to show that the performance of CBL-101 Eye     Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe     keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-101 Eye Drops     during a 90-day period with treatment administered 3 to 6 times per day.   "
23762|NCT02974634|"     The purpose of this study is to test the benefits of an educational program, the Ostomy     Self-Management Training (OSMT) program, for improving patient activation (preparedness to do     self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy     self-care, quality of life, mood, use of medical services, and financial burden in patients     with ostomies. The study will compare patients in the intervention (training) group and     patients in the usual care group.      Subjects' participation in this study is expected to last about 7 months. The PI plans to     enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School     of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be     coordinated by the University of Arizona in Tucson, Arizona.   "
23763|NCT02974621|"     This randomized phase II trial studies how well cediranib maleate and olaparib work compared     to bevacizumab in treating patients with glioblastoma that has come back. Cediranib maleate     and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of     tumor cells to grow and spread.   "
23727|NCT02975089|"     The proportion of the elderly population has increased rapidly worldwide. Frailty is a common     geriatric syndrome. Comprehensive dietary management strategy may have beneficial effects on     frailty prevention and reversal. We compared the effects between micronutrients and/or     protein supplement, and balanced diet on frailty status in elderly individuals who were at     either pre-frail or frail stage. A total of 37 subjects completed a 3-month paralleled,     single-blind, randomized control trial on (1) multiple nutrients supplementations, (2)     multiple nutrients plus isolated soy protein supplementation, and (3) individualized     nutrition education with designed dishware for balanced diet as well as food supplementations     (mixed nuts and milk powder). Intervention effects on dietary intakes, biomarkers, frailty     score and geriatric depression score (GDS) were assessed. The nutrition education     intervention with designed dishware and milk powder/nuts supplement significantly increased     the intake of vegetables, dairy, and nuts, along with increased concentration of urinary urea     nitrogen of the pre-frail/frail elders. It yielded a significant reduction in frailty score     (p<0.05) and a borderline decrease (p=0.063) in GDS-SF. Our study indicated that the dietary     approach with easy-to-comprehend dishware and food supplements to optimize the distribution     of multiple dietary components showed its potential to improve not only frail status but also     psychological condition in elderly.   "
23728|NCT02975076|"     Agents of sanchi have been widely used as a complementary medicine for stroke in China.     Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger     anti-platelet activity than other agents of sanchi. The investigators's aim was to     investigate the synergistic action of aspirin combined with sanchitongshu capsule in the     treatment of patients with minor ischemic stroke and transient ischemic attack.   "
23729|NCT02975063|"     Investigators will use a cluster-randomized design with three study arms to evaluate the     impact of the Alive & Thrive infant and young child feeding communication strategies in Lagos     and Kaduna States, Nigeria. This is a mixed methods evaluation and the quantitative data will     be complemented by qualitative data obtained from different groups targeted by or involved in     the program.   "
23730|NCT02975050|"     This study has the following objective:      • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration     Rate (RR), Posture and Activity in healthy human subjects.      The μ-Cor validation will be demonstrated at two body locations:        1. Side location (below left armpit) for study arm 1, and        2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will          be used to support the validation of the study device.   "
23734|NCT02974998|"     This two-arm cluster randomized trial will test a gender-focused comprehensive HIV testing     and counselling (HTC) program, the Young Women's CoOperative (YWC) with a standard HTC     program and will target female adolescents (aged 16-19) who use substances and have dropped     out of school. To evaluate the process, the study will examine the feasibility of using peer     role models as recruiters and co-facilitators of the intervention and monitor fidelity to the     intervention. Efficacy of the intervention on behavioral and biological outcomes, and on     linkages to health services, through follow-up visits conducted 6- and 12-months     post-intervention will be also assessed.   "
23735|NCT02974985|"     Hyaluronic acid (HA) fillers are tested in-vitro to measure their lifting capacity,     viscosity, cohesivity, and rheologic properties, and their lifting capacity has been tested     in animal models. To date, there are no studies that measure the lifting capacity of fillers     in an in-vivo human model.      The intention is to study the lifting capacity of fillers in a group of patients by comparing     pre and post-procedure two and three-dimensional photographs using analytic software.     Specifically, the PI is interested in determining the amount of tissue elevation created by     injecting HAs Restylane-Lyft®, (Galderma Laboratories, L.P., Fort Worth, TX) to the midface     and to the lower face, both in the anterior-posterior direction and in the vertical direction     using analytic software.      The research group has identified a reliable and reproducible quantitative assessment of     midfacial position called WIZDOM (Width of the InterZygomatic Distance Of the Midface) to     quantitatively evaluate the midface. It can be used as an objective tool to assess midfacial     rejuvenation, whether with fat, fillers, or midface or facelift surgery. The Distance from     WIZDOM to inner canthus, the WIZDOM -IC measurement increases with aging as the face deflates     and descends, and, in the practice, is also a means of assessing the midface in youth and in     aging. The PI's findings have been submitted to the Aesthetic Surgery Journal. The practice     will attempt to utilize this metric as a measure of midface aesthetic lifting capacity.      The practice will also employ 3 D photography and analytic software to determine degree of     lift in mm in the y and z axis. (vertical and AP increase in dimension) pre and post-     injection. (Vectra, Canfield, Fairfield, NJ)      A secondary goal of this study is to measure duration of efficacy and patient satisfaction at     various endpoints. A standardized rating system will be used - the Medicis Midface Volume     Scale (MMVS) -measured by three independent physicians and the subjective Global Aesthetic     Improvement Scale (GAIS) -measured by the subject and three independent physicians -to     monitor outcomes at follow-up.   "
23736|NCT02974972|"     In this study, the investigators conducted research among HIV-infected and -uninfected     pregnant and lactating women to understand the potential role and importance of food     insecurity on participant physical and psychosocial health and nutrition.   "
23737|NCT02974959|"     The purpose of this single-center, prospective, randomized (1:1), double-blind,     sham-controlled parallel-arm pilot study is to provide initial evidence of use of the     noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and     moderate traumatic brain injury to improve clinical recovery. The study compares the safety     and effectiveness of an active gammaCore treatment against a sham treatment.   "
23738|NCT02974946|"     This is a prospective randomised control trial 1:1 in patients at risk of developing Acute     Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical     treatment. 110 patients will be recruited for each group. The aim of the study is to assess     whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as     compared to current practice.   "
23739|NCT02974933|"     The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with     pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line     of treatment of progression-free survival   "
23789|NCT02974283|"     The purpose of this study is to find out a serum marker for the evaluation of blood brain     barrier damage based on animal experiments and investigate the effect of NBO（Normobaric     hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA     thrombolytic therapy.   "
23790|NCT02974270|"     Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide     acetate   "
24357|NCT02966847|"     In the coming years, an increase in lung nodule resection is expected, particularly in     Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a     device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a     tool whose use is constantly spreading.   "
23740|NCT02974920|"     Aortic valve replacement with a biological prosthesis is the most common valve surgery     performed with about 1000 operations performed in Denmark each year. Further, the     introduction of percutaneous stent valves will increase these types of replacements in the     years to come. A biological valve is a foreign body prone to cause thrombus formation at     least until the valve is covered with recipient endothelium. There are no conclusive studies     of anticoagulation and the investigators have shown stroke to be a common complication.     Guidelines have variably recommended aspirin or rivaroxaban for anticoagulation, and     currently aspirin is the most common recommendation. In a register study, the investigators     have shown that proper anticoagulation with warfarin is likely to be superior. There is a     clear need for a large randomised study of aspirin versus anticoagulation for biological     aortic valve replacement. This protocol describes a randomised study where 1000 patients will     be randomised to receive either rivaroxaban or aspirin for 6 months following aortic valve     replacement with a biological prosthesis. The primary efficacy endpoint is a combined event     of all-cause mortality and hospitalisation for either acute myocardial infarction or stroke.     This study has the power to settle a discussion of appropriate anticoagulation for this     operation   "
23741|NCT02974907|"     The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic     Solutions to placebo for the treatment of the signs and symptoms of dry eye.   "
23742|NCT02974894|"     In the present study the main goal has been to clarify the effect of the probiotic bacteria     Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination     stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative     marker of stress. The hypothesis was that the levels of cortisol would be reduced or     stabilized in the test group in comparison to the placebo group where the cortisol levels     were expected to increase due to the examination-induced stress. By contrast, the salivary     IgA levels were expected to increase in the test group in comparison to the placebo group.   "
23743|NCT02974881|"     Multicenter feasibility study of the HighLife™ TMVR system.   "
23744|NCT02974868|"     Study B7931005 will investigate the JAK3 inhibitor PF- 06651600 and TYK2/JAK1 inhibitor     PF-06700841 in Alopecia Areata. This Phase 2a, randomized, double blind, parallel group,     multicenter study will enroll a total of approximately 132 subjects (expect to provide     approximately 90 completers). The study will be conducted at approximately 30 to 40 sites.   "
23745|NCT02974855|"     This study is designed to evaluate the safety, tolerability, pharmacokinetics,     pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of     PF-06741086 in subjects with severe hemophilia.   "
23746|NCT02974842|"     This study evaluates the ability of the MAKO 7 device to collect various cells   "
23747|NCT02974829|"     The purpose of this study is to conduct an investigator initiated observational study to     continue to follow up the China subset of study participants for another 5 years after they     complete participation in the REALM Study   "
23748|NCT02974816|"     The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2     diabetes managed via usual care alone and usual care augmented with remote monitoring using     Glooko   "
23749|NCT02974803|"     Dabrafenib and trametinib are drugs that are usually given for the treatment of melanoma.     Combinations of dabrafenib and trametinib have also been studied and when used together have     shown to increase tumour shrinkage in animals compared to either drug alone. Dabrafenib and     trametinib have also shown potential to penetrate the blood-brain-barrier when given together     and have an effect on brain metastases. Giving these drugs at the same time and then giving     brain stereotactic radiosurgery (SRS) may also be preferred in patients with brain metastases   "
23750|NCT02974790|"     After a basic training to echocardiography, emergency physicians will have to answer simple     clinical questions about circulatory failure mechanisms. The objective of the study is to     assess the agreement between these answers and those of the expert physician in patients     admitted in the emergency department with a circulatory failure due to sepsis or not.     Emergency physicians will volunteer to take part in a basic training on echocardiography. The     training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of     tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice     sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the     different views and to identify the anatomical structures. The second part of the study will     start after the training. Each eligible patient will be successively assessed by two     investigators: one emergency physician recently trained and the expert physician. The     echocardiography will be performed as soon as possible in the emergency department before or     after the initiation of treatment without delaying it. The order of hemodynamic assessments     will be random depending on the availability of the investigators; both assessments will     however be performed within 30 minutes. Each investigator will independently read the     echocardiography in real time at patients' bedside. They will then answer a limited list of     standardized questions using two-choice answers or predefined choices. Finally investigators     will choose a therapeutic proposition among a predefined list based on the answers. Only the     results of the echocardiography performed by the expert physician will be used in patient     management.   "
23751|NCT02974777|"     The purpose of this study is to determine the efficacy and safety of a routine individualized     antiplatelet therapy after coronary stent implantation by evaluating on-treatment platelet     reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).      IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on     bleeding events and net clinical benefit   "
23791|NCT02974257|"     This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate     in patients who initially survive an in-hospital cardiac arrest. Patients who are     successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical     ventilation in the intensive care unit will be enrolled, and will get either thiamine or     placebo. Their oxygen consumption and lactate will be measured at serial time points and     compared between groups. The investigators' hypothesis is that thiamine will help restore the     body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in     oxygen consumption and a decrease in lactate.   "
26027|NCT02945020|"     The purpose of this study is to evaluate the effect of steady-state concentrations of     odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the     single-dose pharmacokinetics of dabigatran etexilate in healthy participants.   "
23752|NCT02974764|"     Pancreatic adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality in the     United States. The high mortality for these tumors is primarily attributed to the late stage     in which most patients are diagnosed, leading to a dismal 5-year survival of 6% for all     stages of PDAC. Surgical resection offers the best chance for survival, but most patients     only present with symptoms after the tumor has metastasized, and as a result are not     operative candidates. This creates a need to both identify patients at an earlier stage while     their cancer is still resectable, and predict the aggressiveness of the disease in order to     better target treatment. In addition, even patients who receive curative surgery are at a     high risk of developing recurrence of disease. Thus, there is also a need to detect     recurrence early so appropriate treatment can be provided. As several adjuvant     chemotherapeutic regimens are now available, it will be important to identify as soon as     possible that the cancer has become refractory to a given therapy. This will allow one to     progress to second or third line therapy more quickly while the tumor burden is smaller. This     purpose of this study is to identify biomarkers in the blood of patients with PDAC and     determine how they can change over time in relation to treatment to assess for any     correlation with patient outcomes, response to treatment, recurrence of disease and overall     survival. This study will be limited to patients who present to the Johns Hopkins Hospital     between January 1, 2015 and December 31, 2018 with PDAC. Blood will be drawn from all     consenting patients at the time of initial diagnosis and after treatment. Patients will     undergo treatment for their cancer based on personal preference, standard guidelines and     discussion with medical, radiation, and surgical oncologists. Patients who undergo surgical     resection will also have an additional blood sample collected after resection, and patients     who undergo chemotherapy and/or radiation will have an additional blood sample draw at the     end of this treatment. A patient could have blood collected at multiple intervals, i.e. a     pre-treatment sample, sample post-neoadjuvant chemotherapy/radiation, sample post-surgery,     and sample post-adjuvant chemotherapy/radiation. In patients, who have undergone curative     resection of PDAC blood samples will be collected till they develop clinical recurrence of     disease. For the first 2 years following surgery samples will be collected every 3-4 months.     Beyond that the investigators will collect samples every 6 months for the next two years. For     all patients found to be alive and disease free beyond 4 years after surgery samples will be     collected once every year. These patients will be followed to determine disease-free and     overall survival. With this study, the investigators aim to assess the potential utility of     blood biomarkers over time for pancreatic tumors which will help both with early detection of     disease and also recurrence of disease after surgery. Biomarkers identified would have the     potential to create a new method for early diagnosis of patients with PDAC, predict overall     survival, response to treatment, or risk of metastatic spread, and predict recurrence of     disease, all of which has the potential to drastically improve outcomes for this deadly     disease.   "
23754|NCT02974738|"     The primary objective of this study is to identify the maximum tolerated dose (MTD) of PT2977     Tablets and/or the recommended Phase 2 dose (RP2D) of PT2977 Tablets in patients with     advanced solid tumors   "
23755|NCT02974725|"     To characterize safety and tolerability of LXH254 and LTT462 combination and identify a     recommended dose and regimen.   "
23756|NCT02974712|"     This study aims to investigate the effects of different methods of administration on     emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral     endoscopic operation   "
23757|NCT02974699|"     There is currently a critical gap in knowledge of how intestinal bacterial communities alter     metabolic substrates available to the host thereby influencing central and enteric nervous     system (CNS/ENS) neurotransmitter levels involved in regulating carbohydrate consumption in     humans. Understanding these relationships is essential for developing strategies to improve     blood glucose control and to reduce the risk of transitioning from prediabetes to type-2     diabetes (T2D). The investigators' long-term goal is to determine the biological     underpinnings of behaviors that impact food intake and blood glucose control that contribute     to the development of T2D. The objective of this proposal, which is an essential next step in     attaining the investigators' long-term goals, is to determine how bacterial populations in     the digestive system impact circulating tryptophan (TRP) and large neutral amino acid (LNAA)     levels that regulate production of monoamine 5-hydroxytryptamine (5-HT, serotonin) in the ENS     and in gastrointestinal system and the brain. The central hypothesis is that a reduced ratio     of TRP producing (TRPp) to TRP consuming (TRPc) bacteria (decreased TRPp:TRPc ratio) in the     gut will decrease TRP availability following a carbohydrate meal lowering the plasma TRP:LNAA     ratio and resulting in less TRP for ENS/CNS production of 5HT. Further, dietary interventions     that promote TRPp bacterial abundance within the gut will increase TRP availability to the     host. The investigators will test the central hypothesis and, thereby, accomplish the overall     objective for this project by pursuing the following specific aims: 1) Assess impact of     divergent microbiota on plasma TRP:LNAA ratio in response to acute carbohydrate consumption,     and 2) Assess the impact of dietary supplementation with resistant starch (RS) on gut     microbiota and circulating TRP:LNAA ratio. During Aim 1, stool samples will be collected from     healthy participants. Participants will be stratified based on gut TRPp:TRPc ratio and the     response to an acute meal will be assessed by determining plasma TRP:LNAA ratios. During Aim     2 the capacity for 4-weeks of pre-biotic RS (Potato Starch) supplementation to increase the     TRPp:TRPc bacterial ratio in the gut will be determined from stool samples. Additionally,     plasma TRP:LNAA ratio following acute carbohydrate consumption before and after     supplementation will be determined. The scientific contribution will be to determine the     impact of RS on TRPp and TRPc bacteria abundance in the gut, and how bacterial populations     impact circulating TRP:LNAA levels, that can impact ENS and CNS 5HT production in humans.     This contribution will be significant because it will have direct translational implications     for human diseases with altered 5HT signaling.   "
23868|NCT02973438|"     The purpose of this research is to examine changes in blood glucose control and metabolism in     individuals with SCI and non injured controls at rest and during exercise after five days of     exposure to IH. This response will be compared with breathing normal room air (a SHAM     control).   "
23758|NCT02974686|"     Patients who receive renal transplantation at BJH are placed on triple maintenance     immunosuppression, which means that patients take 3 types of immunosuppression drugs to     suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone.     However, due to the effects of MPA on the gastrointestinal tract, patients often complain of     GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to     an alternative agent, typically Azathioprine. Both of these strategies have limitations,     largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar     efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse     effects, so the investigators will convert patients to EVR in this study. Patients who are     within their first year post-transplant will be converted to EVR upon enrollment in the     study, and serial measurements ,or a series of measurements looking for an increase or     decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.   "
23759|NCT02974673|"     The objective of this research is to study the sphincter activity during ejaculation in     patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this     purpose, using a catheter the protocol plans to measure the sphincter pressures during     ejaculation. Moreover, cardiovascular parameters will be measured continuously during the     ejaculatory test.   "
23760|NCT02974660|"     Transcatheter aortic valve implantation (TAVI) is a new, rapidly emerging standard of care in     inoperable and high-risk patients with severe, symptomatic aortic stenosis. Information     regarding reversal of unfractionated heparin with protamine sulfate in order to facilitate     access site closure is scarce and based on expert consensus. Clinical practice varies between     centers. Protamine sulphate may decrease the amount of bleeding complications related to the     access-site. The impact on possible thromboembolic complications is unknown. Both bleeding     and thromboembolic complications increase mortality after TAVI. A randomized trial is     required in order to assess impact of protamine sulfate on prevalence and extent of bleeding     and thromboembolic complications.   "
23761|NCT02974647|"     The purpose of this study is to test any good and bad effects of the study drug called     ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another     protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking     JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.   "
25163|NCT02956304|"     The purpose of this study is determine the involvement of motor system in the memory of     manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial     magnetic stimulation to see whether this stimulation will affect memory of manipulable     objects.   "
23764|NCT02974608|"     Background:      Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa,     malaria continues to be the main cause of death in young children and pregnant women.     Researchers want to find out more about how malaria affects pregnant women and their babies.      Objectives:      To study the rate of miscarriage and stillbirth during the second and third trimesters among     women in a certain district in Mali. To study rates of malaria infection over time among     pregnant women and children in this area.      Eligibility:      Pregnant women of any age and pregnancy stage and their newborns. They must live in     Ouelessebougou, Mali. Children up to 10 years old who live there.      Design:      Information about the study will be shared at community meetings, during visits to the health     centers, and during census updates.      Participants will read and sign a consent form.      Pregnant women will be screened to see if they are eligible. They may have a urine test. They     may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures     of the body.      Women will be enrolled in the study after they have their babies.      Participants may have a physical exam.      Some participants will provide a finger/heel prick blood sample.      Participants will complete a questionnaire. They will be asked about:      Medical history      Antimalarial and other interventions      Socioeconomic status      Their pregnancy      Previous pregnancies      Health of their newborn...   "
23765|NCT02974595|"     Background:      Some diseases cause chronic inflammation with intermittent flares in the body. These are     called autoinflammatory diseases. They can cause fevers, rashes, ulcers, and other problems.     Researchers want to learn more about the causes and effects of these diseases. They hope this     will improve how the disease is managed in the future.      Objectives:      To understand the underlying immune dysregulation      To identify the genetic cause      To translate our findings into novel treatments that improve patients disease outcomes      Eligibility:      Patients with known NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still's Disease, and with     other yet undifferentiated autoinflammatory diseases.      Unaffected relatives of participants with a known or undifferentiated autoinflammatory     disease      Healthy adult volunteers at least 18 years of age      Design:      Participants will be screened with blood sample and medical history. They may provide copies     of their medical records.      Enrolled participants will be evaluated at the NIH for 2-5 days. All participants will have a     detailed medical history, physical exam, blood tests, and other evaluations depending on the     extent of their autoinflammatory disease.      Participants may also expect the following assessments:        1. Clinical tests that help assess organ damage and function such as hearing, vision,          memory, and learning tests.        2. Imaging studies to characterize organ involvement of the inflammatory disease including:          X-rays, CT scans, special MRIs, and bone scans.        3. Laboratory evaluations including clinical markers of disease activity, research samples          for genetic studies, blood samples for cytokine/biomarker assessment, and gene          expression profiling.        4. Questionnaires to assess disease activity and quality of life.        5. If indicated, other procedures may be administered that include: a lumbar puncture if          CNS inflammation is suspected, a skin biopsy if skin inflammation is present, and/or          gastrointestinal and pulmonary procedures if they are clinically indicated.      Participants may return for a single follow-up visit or for long-term follow-up visits     depending on their disease and willingness to return. Long-term follow-up may occur for up to     15 years on this protocol.   "
23902|NCT02972983|"     The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in     combination with a beta lactam antibiotic on treating bloodstream infection caused by     methicillin-susceptible S. aureus.   "
23903|NCT02972970|"     Feasibility study to assess the scan, fit and print process for the Aveera Patient Matched     CPAP Mask   "
23766|NCT02974582|"     Background:      Smoking is a major public health problem in the U.S. Almost a half a million Americans die     from it in a year. One thing that contributes to why people smoke is the marketing of     cigarettes. Cigarette direct mail marketing usually targets young smokers of lower     socioeconomic status. Researchers want to find out more about how this kind of marketing     influences smoking behavior in young people from different socioeconomic levels.      Objectives:      To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal.     To study how these things may differ among young adult smokers of high and low socioeconomic     status.      Eligibility:      Healthy adults ages 18 to 29 who smoke.      Design:      Participants will have 1 visit.      Participants will be asked questions about their health and recent smoking.      A nurse will check their vital signs.      Participants will have a simple eye exam.      They will give blood and urine samples.      Participants will be connected to equipment. This will collect data while they look at     pictures.      Then they will have a 10-minute break. A nurse will observe them during the break.      Participants will have their breath analyzed.      Participants will answer questions. The topics will include:      Education      Job      Income      Family history      Tobacco use      Exposure to pro-smoking and anti-smoking messages      History of drug and alcohol use   "
23767|NCT02974569|"     This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates     an image of the symptoms the participant is experiencing, for improving symptom     self-management in adolescents and young adults with cancer. In this one-group trial,     participants will complete the C-SCAT and use it during two clinic visits with their oncology     providers.   "
23768|NCT02974556|"     This study aims to determine the oncological effectiveness, compared to standard surgical     treatment, of proactive management including target organs for peritoneal spread resection     (omentectomy, bilateral adnexectomy, appendectomy, hepatic round ligament resection) and     preventive HIPEC (intraperitoneal oxaliplatin with concomitant i.v.     5-fluorouracil/leucovorin) following a curative resection of high-risk ( >/= 5 mm tumor     invasion beyond the muscularis propria) T3 and T4 colon cancer in preventing the development     of peritoneal metastases. Adjuvant systemic chemotherapy will be reserved in both groups for     patients with poor prognostic factors according to Folinic acid/Fluorouracil/Oxaliplatin     (FOLFOX) or to Capecitabine/Oxaliplatin (CAPOX) regimens.      Hypothesis:      The hypothesis is that compared to the standard treatment proactive management following     curative resection of high-risk T3 and T4 colon cancer will reduce the development of     endoperitoneal metastases   "
23769|NCT02974543|"     The purpose of this study is to develop and test a subject operated device to lessen tinnitus     (ringing in the ear), based on subject-feedback for stimulus presentation.   "
23770|NCT02974530|"     The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing,     Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered,     isolated or associated manner, causing major disorders and representing a source of handicap     for patients.      Understanding the swallowing mechanisms is therefore a major challenge to guide the     rehabilitation and improve the initial and long-term prognosis of patients with stroke.      The main objective of this study is to describe and modeling, thanks to a clinical,     physiological and radiological knowledge base, swallowing, speech and breathing, in patients     with stroke and in healthy subjects.   "
23771|NCT02974517|"     Nowadays, the rapid development of human assisted reproductive technology (ART) has provided     many help for couples with fertility issues. Even take baby home rate has been increased     dramatically in the past several decades; both clinicians and embryologists are still     struggling to improve pregnancy rates. Among all the strategies that the embryologists have     tried, much work has been done to find better embryo culture conditions and embryo quality     evaluation system. Currently, most centers in the world, including ours, are still using     conventional incubators and manual embryo scoring system. This traditional method has several     limitations, such as unstable environment during culture, and embryo scores can be different     judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse     embryo culture and analysis system. It is user-friendly, and suited for routinely daily use.     In addition, its KID Score system can help embryologist select high quality embryos quickly,     which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this     prospective cohort study is to evaluate the use of EmbryoScope® in our center.   "
23772|NCT02974504|"     A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV     clinical trial to investigate the effect on blood glucose of evogliptin after oral     administration in patients with type 2 diabetes   "
23773|NCT02974491|"     The investigators hypothesized that acute consumption of Fuji apple juice (AJ) could increase     the antioxidant status and/or decrease the oxidative stress (OS) biomarkers, without     increasing serum biochemical parameters in patients undergoing maintenance hemodialysis     (MHD). In this pre-post pilot feasibility study, patients served as their own controls,     received 300 and 150 mL AJ immediately after a dialysis section, on different days, with a 3     week-washout period. Blood was collected at the baseline period, after 30 and 60 min of AJ     consumption. OS biomarkers (total antioxidant status (TAS), total oxidant status (TOS),     ascorbic acid, catalase (CAT), glutathione peroxidase (Gpx), superoxide dismutase (SOD) and     reduced glutathione (GSH) and potassium, phosphorus, uric acid, and glucose concentrations     were analyzed.   "
23774|NCT02974478|"     Aim of the study is to investigate the impact of orange juice consumption (with meals or     between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on     glucose homeostasis and antioxidative status.   "
23775|NCT02974465|"     The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper     limb hemiparesis added to conventional physical therapy on changes in upper extremity     functionality, motor recruitment pattern and range of motion (ROM) compared to the single     application of conventional physical therapy. It aims to find a 22.22% difference between     both interventions.   "
23844|NCT02973750|"     While significant progress has been made in the treatment and prognosis of ovarian cancer,     this progress has mostly shown benefits for younger women.      This study aims to understand two things: How body composition (the amount of muscle and     water versus fat in in the body) affects the dose and side effects of chemotherapy; and the     biological reason for the worse prognosis with aging. To get a good view of these effects,     investigators are asking the help of both younger and older women for this project.   "
23776|NCT02974452|"     A cross-sectional descriptive study, in which the surface electromyographic activity of five     shoulder muscles was compared in three populations: older adults, middle-aged adults and     young adults. The evaluation of the electromyographic data offers a suitable foundation to     understand aging process.      This supports that surface electromyography provide information about the aged shoulder     muscles. Loss of functionality is suffered by a high percentage of older adults, which     greatly limits their physical activity. In this sense, this paper presents findings that     might be related with possible therapeutic approaches in subsequent studies.   "
23777|NCT02974439|"     This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5     mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a     washout period of 14 days   "
23778|NCT02974426|"     Rationale: Completely resected non-small cell lung cancer (NSCLC) patients with     histologically confirmed N2 disease are a heterogeneous population. After complete resection     and postoperative chemotherapy (POCT), 20%-40% of cases have a risk of locoregional     recurrence (LRR). Postoperative radiation therapy (PORT) should be an integral component of     the multidisciplinary treatment for patients with stage IIIA(N2) disease. Postoperative     Radiotherapy (PORT)-first strategy may have an advantage of the early administration of     locoregional therapy to the mediastinum, in which the tumor burden is presumed to be higher     than that of systematic micrometastases. It is not yet known for subsets with specific     prognostic factors that confer higher LRR risks, what is the optimal timing of PORT and how     to integrate with POCT (in a sequential fashion or concurrent fashion) when PORT is     considered for patients with completely resected stage IIIA(N2) NSCLC.      Purpose: This randomized phase III trial is studying the optimal timing of PORT to evaluate     whether the PORT-first strategy (PORT administered first with concurrent or subsequent POCT)     may be more effective than the PORT-last strategy (PORT administered sequentially following     POCT) in treating high risk of LRR patients with completely resected pathologic stage     IIIA(N2) NSCLC.   "
23779|NCT02974413|"     This research project has the main objective to analyze the benefits of self-care supported     for adult men with Diabetes Mellitus. Treat yourself will randomized-controlled clinical     study, randomized cluster to be developed with men aged between 40 and 70 years who have type     2 diabetes and are registered with the Health Strategy teams of the Municipality of Family     Maringa. The recruited subjects will be randomly allocated into two groups: intervention     group and control group. In the first, individuals will participate in a self-care     intervention supported by a nurse, based on supported self-care and behavior change protocol;     and second, individuals participate in conversation circles and will have the assistance     normally provided by health services. The follow-up will take place for six months and will     be collected information: socioeconomic, demographic, behavioral health, complications,     laboratory and anthropometric. It is intended, through this study, demonstrate the     effectiveness of this type of intervention, user-centric, on the health of men with DM,     reinforcing this option of choice for professionals and users within the Primary Health Care     (PHC).   "
23816|NCT02973932|"     Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms     and an age of 7 to 17 years. Sessions are verified with teleconferencing with an     psychotherapist, children and their parents. The psychotherapy is supported by an App and a     wristband to obtain psychophysiological data.   "
23780|NCT02974400|"     Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and     societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis     (CBTp), its dissemination into routine mental health care remains poor. National regulations     such as the National Institute for Health and Care Excellence (NICE) guideline in the United     Kingdom recommend that CBTp should be offered to every person with psychotic symptoms, but     more than 50% do not receive even a single session of CBTp. In Germany, CBTp is virtually not     represented in the psychotherapy health service. Internet-based cognitive behavioral therapy     (CBT) in a self-help format has been proven feasible and effective in anxiety and depressive     disorders. Recently, Internet-based (self-help) interventions are also deployed via     smartphone apps. The feasibility of Internet-based treatments for people with schizophrenia     is well documented for Internet-based interventions (e.g., medication management) and also     reported for smartphone interventions. However, there is a dearth of empirical studies     precluding a conclusive picture. As far as the investigators know, there is only one study     encompassing 90 participants with psychosis that investigated an Internet-based intervention     with symptom-specific, cognitive behavioral interventions, which is from the investigators'     research group. The unique features of the proposed project are 1) the first-time evaluation     of a symptom-oriented, CBTp-based self-help treatment for people with psychotic symptoms via     Internet, enhanced with smartphone assistance. The study is set up as randomized controlled     trial (RCT) with active treatment versus a wait-list control group. It evaluates a combined     Internet-based guided self-help treatment for persecutory ideation and auditory verbal     hallucinations. The active treatment condition consists of access to a self-help website     including regular written electronic contact with a guide and access to smartphone-based     interactive worksheets (apps). The trials combine the low-threshold advantages of an online     approach (e.g., anonymity) with the virtues of a clinical trial (e.g., symptom assessment and     diagnostic verification via Interview). The primary outcome measure is the Positive and     Negative Syndrome Scale (PANSS). Secondary outcome measures include self-reported symptom     measures (Paranoia Checklist; Beliefs About Voices Questionnaire revised), completion rates,     drop-out from the intervention, general symptomatology, side-effects, and client     satisfaction. The project will help to answer the empirical question whether CBTp-based     interventions in a purely Internet-based self-help format are effective. Positive findings     would pave the way for an easy-to-access treatment option for patients with psychotic     symptoms who currently are deprived of psychotherapeutic treatment.   "
23781|NCT02974387|"     STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing     and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy     (PRK) surgery.      OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral     (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the     eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months     Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for     one month, 3 x a day for one month and 2 x a day for one month Study medication will be     administered to the randomized eye through post op days according to mention protocol. Visit     Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal     re-epithelialization).   "
23782|NCT02974374|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a     single dose of PF-06835919 in healthy adult subjects.   "
23783|NCT02974361|"     This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.     Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new     version of ibuprofen is expected to produce fewer stomach/intestine related side effects when     compared to many existing marketed formulations of Ibuprofen.      This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way     crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and     allocated interventions will be confirmed after review of data from Parts A and/or B     respectively.      A total of 30 subjects will take part in the study; 10 per study part.      The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and     without a selection of different excipients. The pharmacokinetic properties will include how     quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug     that reaches the bloodstream.   "
23784|NCT02974348|"     The antimalarial drugs efficacy and safety study will be conducted in the Clinics and     hospital of the Cameroon Development Corporation (CDC) Estates, Tiko Health District, located     in a typical forest and rainfall area in the South West Region Cameroon. In this study, 350     children aged 6 months to 5 years who are found to have uncomplicated symptomatic malaria     will be enrolled between October 2012 and March 2013. Participants will be randomized to     receive one of the following medications.      (i) DHA+PQ : dihydroartemisinin, 2.5 mg per kg, plus piperaquine phosphate, 20mg per kg daily     for 3 days; (ii) ART LUM : Artemether, 2mg per kg, plus lumefantrine 10mg, twice daily for 3     days; (iii) AS+MQ: artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day     for 3 days.      All study medications will be administered orally The Primary objective of this study are to     compare the efficacy, safety and tolerability of orally administered artemether plus     lumefantrine (ART+LUM), artesunate plus mefloquine (AS+MQ) and dihydroartemisinin plus     piperaquine (DHA+PQ) combinations in the treatment of uncomplicated falciparum malaria in     Cameroon in order to provide evidence that can be used to determining the optimum antimalaria     treatment policy in Cameroon. The secondary objectives are as follows (i) To valuate the     efficacy and safety of artemether plus lumefantrine (ART + LUM) and artesunate plus     mefloquine (AS + MQ) versus dihydroartemisinin plus piperaquine (DHA + PQ) combination (ii)     To compare the clearance of asexual parasites and gametocytes in each treatment arm (iii) To     assess the clearance of fever (iv) Assess effect of each treatment arm on anemia This study     is a randomized, double blinded clinical trial. After enrollment, participant will be     randomized to one of the three treatment regimen. The treatment outcome will be assessed     through a 42-day efficacy study. Participants who will exhibit early or late treatment     failure and those with adequate clinical response and parasitological failure on day 14, 28     or 42 will be treated with quinine (25mg base per kg body weight per day in three divided     doses for five days). In addition to antimalarial drugs oral paracetamol (50mg/kg body weight     per day in three divided doses) will be administered for fever exceeding 37.5%. Polymerase     Chain Reaction (PCR) -corrected 28 day and 42 day efficacy will be evaluated for each     treatment episode.   "
23785|NCT02974335|"     This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and     utilizing the CDEs in clinical practice requires a strategy for implementing screening to     collect substance use information that populates the CDEs, and assisting primary care     providers to offer appropriate interventions by providing clinical decision support (CDS) and     a mechanism for making referrals to addiction treatment. We aim to maximize the efficient     adoption of screening, CDS, and treatment referrals by integrating all of these activities     into the electronic health record (EHR).      The study will be conducted at three sites, representing three large health systems. Each     phase will include deliverables essential to move to the next phase, and an independent     Advisory Committee will review progress and make recommendations at each transition about how     best to progress to each subsequent phase. Based on progress during earlier phases, the     Advisory Committee may recommend expansion to additional clinics or health systems during the     second part of Phase 4.   "
23787|NCT02974309|"     A three month randomized study to examine the potential benefits of sleep extension in tandem     with clinical trial on diabetes management in youth with type 1 diabetes.   "
23788|NCT02974296|"     The goal of this project is to guide rTMS using fMRI in individuals with depression who did     not respond to standard TMS treatment to evaluate whether targeted TMS using individualized     functional MRI scans produce outcome superior to that of conventional approaches. The study     team also plans to scan patients with Major Depression Disorder (MDD) patients prescribed to     receive standard TMS for the first time before and after which they will have resting-state     Functional Magnetic Resonance Imaging (rs-FMRI) scan in order to see if we can predict their     responsiveness based on the functional connectivity maps.   "
23792|NCT02974244|"     Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment     of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves     glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as     necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages,     such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid     profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes     in customary clinical care is unknown.      The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative     to basal insulin initiated as first-ever injectable therapeutic regimens used in customary     clinical care. Patients who initiated treatment with Bydureon or basal insulin between July     2011 and March 2015 will be recruited into the study cohorts from Optum's database of     electronic health records. The two treatment cohorts will be matched by propensity score     method.Clinical outcomes of HbA1c, weight, and gastrointestinal symptoms and hypoglycemia are     investigated.   "
23793|NCT02974231|"     The objective is to report outcomes,including grade ≥2 overall late rectal and urinary     toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)   "
23946|NCT02972437|"     The investigators intend to screen children who are suspected of having GAS tonsillitis. From     each child we will take a throat culture and saliva sample to screen for molecular evidence     of GAS.   "
32094|NCT02865681|"     The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins     (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor     any and all side effects of the nasal Menopur.   "
23794|NCT02974218|"     The Cliniques Universitaires Saint Luc are one of the high specialized center in valvular     heart diseases and valvular heart surgery. Aortic stenosis, mitral and aortic regurgitation     are the three valve pathology that are mainly frequent and studied.      International guidelines in the management of valvular heart diseases are based on few     limited old studies, mainly retrospective. And, a matter of concern is staying, about the     timiong of surgery for asymptomatic patients.      A prospective registry will help us to better understand the pathologies and try to better     define guidelines criteria for surgery.   "
23795|NCT02974205|"     The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are     varying. The purpose of the study is to explore if one rehabilitation option is preferable to     one other for patients with acute PCL injury, by examining whether there will be differences     in laxity in the knee joints and patient-reported knee function by three different     rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be     followed up 3 and 12 months after injury. The groups will be compared using kneelaxity     (stress - X) and subjective knee function (KOOS, IKDC-2000)   "
23796|NCT02974192|"     Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of     death and disability in industrial world. Inflammation has been reported to constitute a     major component of ischemic stroke pathology. The brain responds to ischemic injury with an     acute andprolonged inflammatory process. Few studies have investigated the relationship     between acute biomarkers of inflammation and functional outcome following stroke   "
23797|NCT02974179|"     Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the     AG-CLI-0206-LTFU study   "
23798|NCT02974166|"     The purpose of this study is to determine whether osteopathic manipulative treatment     associated to Dentistry care and speech therapy improves pain and function in individuals     with temporomandibular disorders.   "
23799|NCT02974153|"     The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of     migraine headache in chronic migraineurs.   "
23800|NCT02974140|"     The purpose of this study is to compare the refractive predictability (prediction error)     between the Cataract Refractive Suite (CRS) and standard manual technique at one month     post-operative   "
23801|NCT02974127|"     This is a prospective observational trial consisting of robotic multisession radiosurgery     (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial     meningiomas.   "
23802|NCT02974114|"     This parallel, assessor blind, placebo-controlled, stratified, randomized study will     investigate the effects of everyday pain on cognition and mobility in otherwise healthy     individuals.   "
23803|NCT02974101|"     This is a prospective, multi-center, correlation study in which the investigators aim to     explore the relationship between subjective pain questionnaires and the AdaptiveStim     accelerometer output.   "
23804|NCT02974088|"     This was a Phase IIa randomised, assessor blinded, parallel group study in which half the     participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with     a head louse detection and removal comb and the remainder were treated with Nice 'n Clear     plus combing with a normal grooming comb   "
23805|NCT02974075|"     Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer     patients will develop biochemical recurrence after radical prostatectomy (RP), potentially     because of micro metastasis at the time of the primary surgery.      With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT,     which allow the localization of the site of recurrence, there is increasing interest in     metastasis directed therapies, such as salvage lymph node dissection.      The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating     prostate cancer patients with local recurrence after radical prostatectomy with curative     intent. Several retrospective series has been published to determine the local value of sLND.     Despite the first data seem to be feasible and promising, to date no prospective evaluation     has been made. Thus sLND is still experimental according to the guidelines and is considered     as an off label therapy.      This prospective single center phase I/II study was conducted to investigate the safety and     early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic     recurrence after radical prostatectomy (RP) with curative intention.   "
23806|NCT02974062|"     The purposes of this study were to 1) determine test-retest reliability of an iPhone     application measurement and protocol, 2) establish minimal detectable change of an iPhone     application measurement and protocol, and 3) determine the immediate effect of core     stabilization exercise on trunk proprioception in healthy individuals.   "
23807|NCT02974049|"     The recommended treatment for elimination of LF in sub-Saharan Africa is annual mass drug     administration (MDA) with single dose Albendazole (ALB) plus Ivermectin (IVM) given for at     least 5-7 years. However, in areas where LF is co-endemic with a related filarial parasite,     Loa loa, co-infection with L. loa represents a serious barrier to LF elimination because IVM     used in LF MDA can result in severe reactions and even death in individuals with high     microfilaria (mf) levels of L. loa. Screening for heavy L. loa infection is problematic. To     overcome this problem, monotherapy with ALB is possible, since this drug has little or no     effect on circulating mf and thus would not cause adverse effects in people with heavy L. loa     infections. Moreover ALB has been shown to have embryostatic or embryocidal effects in female     adult worms resulting in decreased mf levels with time as natural attrition of circulating mf     occurs. Thus this open-label, randomized clinical trial will examine treatment with ALB     monotherapy administered twice per year over a period of 3 years with the primary endpoint     being the proportion of individuals with total clearance of mf at 36 months and Alere antigen     test negativity (a more sensitive circulating antigen test of filarial infection). Two of the     treatment arms will include ALB at two different doses, 400mg or 800mg (fixed dose twice     yearly) as compared to standard treatment of ALB (400 mg) plus IVM (150-200 µg/kg)     administered annually. Observations from an ongoing clinical trial in Papua New Guinea     suggest that a single dose of triple therapy with ALB + IVM + DEC may be highly effective in     sterilizing adult female worms. Therefore to confirm and expand these important preliminary     observations in a different population, a fourth arm will be included in the current clinical     trial in which subjects will receive all three drugs. The clinical trial will be performed in     a region of Cote d'Ivoire where onchocerciasis and loiasis are not endemic.   "
23830|NCT02971761|"     This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in     treating patients with androgen receptor positive triple negative breast cancer that has     spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may     interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth     of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking     the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better in     treating patients with androgen receptor positive triple negative breast cancer.   "
23808|NCT02974036|"     The overall purpose is to study quality in patient education by means of the patients'     self-rated enablement. Specific aims are:      To assess the validity of the patient enablement instrument in relation to self-efficacy and     empowerment; To investigate if patient enablement can be effective in identifying which     patients would benefit the most from patient education; To study if patient enablement has     any relation to self-efficacy, function or self-rated health; To analyze if patient     enablement has a causal effect on health care consumption; To evaluate whether patient     education is a cost-effective intervention. The project is a longitudinal study, including     patients from a patient education programme for osteoarthritis in primary health care. Data     consist of patient reported outcome measures and health care consumption. Cost-effectiveness     and cost-utility analysis will be used. Inclusion of patients will start August 2016.     Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included     are from primary health care settings and researchers in the field of OA, patient education     and health economy. Our increasingly older and more inactive population will raise huge     demands on the health care. The importance of optimizing treatments that are available in     primary health care cannot be underestimated. The project will contribute with important     knowledge about the patient's own process of getting well.   "
23809|NCT02974023|"     The current study was designed to evaluate the effectiveness and safety of the device in the     common areas of the body affected by different causes of musculoskeletal pain in Vietnamese     population in real life situation.   "
23810|NCT02974010|"     NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of     d-cycloserine (DCS) and lurasidone for the maintenance of remission from Acute Suicidal     Ideation (C-SSRS level 4 or 5) and Behavior (ASIB) in adults with Bipolar Depression     following initial stabilization. Patients with Bipolar Depression and ASIB will be recruited     in both inpatient and outpatient settings and, following informed consent, will be given an     intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory     clinical response to ketamine will be randomly allocated to NRX-101 or to a comparator group.     The primary outcome variable is time to relapse as defined by a return to baseline in either     depression or suicidality as determined by the treating physician or the need to institute a     new treatment plan.   "
23811|NCT02973997|"     This phase II trial studies how well pembrolizumab and lenvatinib work in treating patients     with differentiated thyroid cancer that has spread to other places in the body or has come     back and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab and     kinase inhibitors, such as lenvatinib, may interfere with the ability of tumor cells to grow     and spread.   "
23812|NCT02973984|"     Preliminary data suggest that:        1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices          (MPI), may influence the anticoagulant prescription in older subjects with Atrial          Fibrillation (AF);        2. the presence of multidimensional impairment, disability and multi-morbidities are          usually not included in the decision algorithm of the more appropriate treatments in          older patients with AF;        3. considering the prognostic information, as calculated by the MPI, can be useful to          physicians in identifying older patients with AF that can benefit from anticoagulant          treatment in term of increased survival.   "
23813|NCT02973971|"     The present single center clinical chronobiological study on 24 subjects (12 patients with     mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing     the ADDIA biomarkers: a) blood cell‐based biomarkers measured by flow cytometry using     proprietary probes specific of two targeted biomarkers, beta‐Amyloid (Aβ) peptide and a     kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be     analyzed on samples taken at different time points of the day, including under fasting and     non-fasting conditions and at two periods: day 1 and day 14.   "
23814|NCT02973958|"     Circumcision is the most common surgical procedure performed by Pediatric Urologists.     Ketorolac has been shown to have an efficacy similar to morphine in multi-modal analgesic     regimens without the commonly associated adverse effects. This study aims to see if giving     ketorolac during the operation will result in better pain control. We hypothesize that     ketorolac will result in pain control similar to morphine with a lower incidence of side     effects such as nausea and vomiting.   "
23815|NCT02973945|"     The aim of this study is to compare exercise capacity in Chronic Obstructive Pulmonary     Disease (COPD) patients before and after an 8 week pulmonary rehabilitation program.      Patients will be randomised in two groups, one arm will received oxygen through High Flow     Nasal Cannula (HFNC) and the other group by The Venturi Mask (VM)   "
23818|NCT02973906|"     The overarching goal of this study is to advance research on family-based prevention of     negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom     personnel by evaluating different formats of a parenting program, After Deployment, Adaptive     Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management     Training-Oregon Model/PMTO, but adapted for military deployed families. The PI will examine     which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors     associated with negative childhood outcomes by improving parenting, child, and parent     adjustment. There is a clear intent to benefit all subjects in this study (except surveyed     teachers), including children.   "
23819|NCT02973893|"     The purpose of this study is to determine if VF001-DP improves wound healing in chronic     venous leg ulcers compared to standard care only.   "
23831|NCT02971748|"     The goal of this clinical research study is to learn if pembrolizumab in combination with     standard hormone therapy can help to control and prevent IBC. The safety of this drug     combination will also be studied.   "
23820|NCT02973880|"     Cataract is an ophthalmic disease that usually affects the elderly population. Cataract     surgery with phaco-emulsification is now the most frequently performed intraocular surgical     procedure in the developed world. However, differences in surgical technique impact the     severity of surgical trauma and post-operative recovery. The amount of post-operative ocular     pain and inflammation plays a significant role in the Patient's perception of the surgical     success.      Several ophthalmic products have been studied in the management of post-surgery ocular     inflammation and pain following cataract surgery. Corticosteroids are considered the gold     standard for the treatment of ocular inflammation, and their most commonly used route of     administration is the topical instillation as eye drops formulation.      After topical administration of Dexamethasone, the concentration in the anterior chamber     increases and declines within hours, necessitating frequent daily instillations of eye drops     for several weeks. This might be associated with compliance issues, particularly in elderly     Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a     less frequent administration could therefore be an attractive alternative.      NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and     Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new     ophthalmic gel, preservative-free formulation has been developed. This new formulation has     been tested in pre-clinical animal studies and in a clinical trial. The new formulation     contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for     food products. It is used in the product as viscosity enhancer and to give to the product     pseudo-plastic characteristics and prolonged ocular retention time.      The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™     gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification     and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy     of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.   "
23821|NCT02973867|"     We showed, for the first time, that Z-score increase during obesity was dependent on sex,     severity of obesity and age but also on the bone site. Although the increase in BMD at     bearing areas seems to be logically explained by the assumption that mechanical stresses have     an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in     BMD at non-load bearing areas such as the radius. These results suggest that changes in     certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover,     the fact that the BMD or Z score is positively and only correlated with muscle mass and not     with fat mass confirm that mechanical stresses are not the only factors acting on bone     tissue.      Our objectives are to determine the relationship between plasma concentration of myokines,     adipokines, bone markers and BMD in obese subjects.   "
23822|NCT02973854|"     Patients seen at the Center for Endometriosis (including those with or without pain)     undergoing laser excision surgery for known or suspected endometriosis will be recruited for     the study.      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum     will be excised (removed).      After surgical excision has been performed, in order to provide standardized specimens for     our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3     mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue     will be sent to histology (SSM) for evaluation and classification as having endometriosis or     not. For each patient in the study, blood will also be collected to look for markers for     endometriosis.   "
23823|NCT02971852|"     Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the     suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas     of the hand that would be covered by a glove. We investigated the effects of hypnotic glove     anesthesia on skin temperature measured by thermography.   "
23824|NCT02971839|"     This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis     (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.   "
23825|NCT02971826|"     The last marketed thrombectomy devices, named stentretriever, permit a better and faster     recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the     brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is     not widely use in Europe and in France. The objective of this study is to assess the interest     of using this device in the standard care of ischemic stroke in the radiology unit of the     hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be     collected in order to determine whether or not this device is useful for the practice of the     radiology unit.   "
23826|NCT02971813|"     While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular     disease (CVD), participation is generally poor. For this reason, the current research, a     prospective, randomized controlled pilot study, will evaluate the impact of a social media     intervention on motivation for exercise and adherence to CR sessions. Participants will be     randomly assigned to a Facebook™ group or an enhanced education comparison group. The     intervention will include access to a private Facebook™ group in which participants will     receive weekly educational posts, weekly provider support and have the opportunity to     communicate with other cardiac rehabilitation patients. Patients in the comparison group will     be given the same educational materials, but these will be supplied in handout form, or email     if the patient is absent from cardiac rehabilitation. Participants will be asked to fill out     a pre-post motivational questionnaire and the total number of sessions attended at the end of     3 months will be tallied. This study is grounded in Self-Determination Theory (SDT) and     utilizes the Behavioral Regulation in Exercise Questionnaire (BREQ-2), which is based on the     SDT.   "
23827|NCT02971800|"     The primary objective is to describe the safety and efficacy of intravenous sodium     fluorescein to visualize ureteral efflux during intraoperative cystoscopy after total     laparoscopic hysterectomy. Secondary objective is to report on surgeon's satisfaction with     the overall use of sodium fluorescein.   "
23829|NCT02971774|"     The aim of the study consists in enriching knowledge of health professionals, on the     functional difficulties encountered by hemiplegic patients outside the hospital, in     particular on hobbies, going out with friends or family, work, daily life and the personal     projects. Another objective is to evaluate the diversity of the attitudes and representations     of the patients about their body damage. Lastly, the study seeks to develop a new grid of     evaluation of the quality of life of the patients, which determines more fields of the     existence significantly impacted by the hemiparesy, from the point of view of the patients.     It is a question of improving the therapeutic care of the patients and to determine if     various therapeutic approaches (occupational, pharmacological, surgical) have an impact on     these various fields. The study will be based on qualitative data (interviews) and     quantitative (questionnaires).   "
23832|NCT02971735|"     New designs of 6-year undergraduate medical education (UME) in Taiwan mainly include (1)     integral curricula of body organ system, (2) multiple methods of clinical teaching and     assessment, and (3) generalism in UME. Accompany with decreasing educational hours in the     classrooms and hospital, essential but minor components of primary healthcare such as     ophthalmology and otolaryngology-head and neck surgery (ORL-HNS) is disproportionately     under-represented in UME. Novel medical education stresses on enabling self-directory     learning and increasing learning hours outside the classrooms. Accordingly, we hypothesize     that innovations in educational technology can enhance the learning outcomes of ORL-HNS. This     study is aimed to determine whether mobile technology in e-learning (M-TEL) is an effective     tool for the instruction of ORL-HNS and to compare effects of different cognitive styles on     learning outcomes of M-TEL with various modules of medical education. This is a randomized     controlled trial. We will recruit 60 UME students without previous training in ORL-HNS to     undergo the Group Embedded Figures Test to determine their cognitive styles such as field     dependence or field-independence. After blinded randomization, students are instructed on two     modules of emergent ORL-HNS disorders, using either a standard e-learning of text-figure     Power Point show or an interactive multimedia module. Subjects are evaluated on emergent     ORL-HNS disorders using text-based assessment and multimedia assessment take place prior to     and following instruction. After 7 days later, they will be assessed using global     satisfaction score and AttrakDiff2 questionnaire. We anticipate that this study can confirm     M-TEL can enhance the efficiency of the instruction of ORL-HNS and understand differences in     learning outcomes of M-TEL with various modules of medical education between field dependence     and filed independence using this platform.   "
23833|NCT02971722|"     JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with     Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09     exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose     covering and islet cell recovering,as well as good tolerance and safety.JY09 has been     approved by China food and drug administration(CFDA) to enter the clinical research     stage(Grant number 2016L04254).This study is designed to assess the     safety,tolerability,pharmacokinetics,pharmacodynamics and potential immunogenicity of JY09 in     healthy Chinese volunteers.   "
23834|NCT02971709|"     Use of shade when outdoors is recommended by health authorities worldwide to reduce overall     exposure to ultraviolet radiation. However, expensive physical environment changes are often     required to provide shade and may be effective only when health education has created a     social environment that motivate shade use. A multi-national research team will explore the     use of built shade in passive recreation areas within public parks and compare use of built     shade between the United States and Australia. The specific aims of the project are to: a)     introduce built shade structures (i.e., shade sails) in public parks in Denver and Melbourne;     b) compare the use of passive recreation areas with and without built shade; c) compare the     change in use of the passive recreation areas in Denver and Melbourne after introduction of     built shade, and d) examine the relationship among social environment and physical features     of the environment and built shade.   "
23835|NCT02971696|"     The aim of the study is to evaluate the efficacy of sorafenib, compared to the best     supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular     carcinoma (HCC) based on etiology of hepatitis C virus.   "
23836|NCT02971683|"     Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With     Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults     With Active Idiopathic Inflammatory Myopathy   "
23837|NCT02973841|"     A novel device attached to ultrasound probe designed to increase success rate and safety of     internal jugular vein cannulation.   "
23838|NCT02973828|"     In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment     to locate the tumour and ensure the radiation is hitting the target.      These x-rays expose patients to additional radiation and the quality of these scans is often     poor which makes it difficult to distinguish tumour from normal tissue and there may be     uncertainty in the tumour position due to movement or shrinkage. To allow for these     uncertainties a large margin around the tumour is also treated, but this means that large     volumes of normal tissue also receive significant doses of radiation, which can result in     early and late toxicity.      MRI (magnetic resonance imaging) is better than CT scanning at being able to tell the     difference between tumour and normal tissues and does not expose patients to additional     radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear     accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the     Institute of Cancer Research (ICR)/The Royal Marsden Hospital (RMH) are currently     installation a prototype, which will be one of the first in the world. This revolutionary     technology has the potential to change the way radiotherapy is delivered. We hope the     improved precision and accuracy in hitting the target will mean reductions in margins around     tumours and that this will lead to higher cure rates with significantly fewer side effects.     Studies are required to simulate treatment on the MR Linac before it can be used in routine     clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and     patients who are currently undergoing treatment. This study will involve imaging with MRI in     healthy volunteers as well as in patient volunteers before and during their standard course     of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR     Linac-based research focusing on clinical application and establishment into a MR-CT and MR     only workflow, treatment adaptation and quality assurance.   "
23839|NCT02973815|"     The goal of the proposed project is to see if an innovative family-based intervention can     reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors     in the home. In addition, the project will also examine how the NU-HOME family intervention     influences children's dietary intake, availability of healthy and unhealthy foods in the home     and served at meals and snacks, physical activity as a family, and child screen time (TV,     game systems). The study will build upon a similar project conducted in an urban area and     translate the lessons learned and adapt the program for a rural community.   "
23840|NCT02973802|"     Phase 1 study to assess the safety and biological activity of ATX-GD-59 in patients with     Graves Disease not currently treated with anti-thyroid therapy. This will be an open label     dose titration involving injections on 10 occasions, each two weeks apart. After dosing is     complete there will be a 12 week follow up period. Blood samples will be drawn throughout the     study to monitor safety and the body's response to the injections. Thyroid function will be     measured throughout the trial to monitor Graves disease progression.   "
23841|NCT02973789|"     The study is a prospective, randomized controlled phase III trial aimed to test the efficacy     and safety of Tumor Treating Fields (TTFields) in combination with PD-1 inhibitors or     docetaxel, for second line treatment of Non-small Cell Lung Cancer (NSCLC) .The device is an     experimental, portable, battery operated device for chronic administration of alternating     electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of     surface, insulated electrode arrays.   "
23842|NCT02973776|"     Vasoconstriction study with LEO 90100   "
23843|NCT02973763|"     Alflutinib Mesylate Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective     Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation     tumor cell in Xenograft mouse model. This study aims at local advanced or metastatic     non-small cell lung cancer patients with T790M drug-resistant mutation.   "
23845|NCT02973737|"     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This     study is a randomized, multi-center, multinational, double blind, active-controlled, parallel     design study of the combination of pyrotinib in combination with capecitabine versus placebo     plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and     trastuzumab.      Patients will be randomized in a 2:1 ratio to one of the following treatment arms:      Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Arm B: placebo     (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm     of therapy until the occurrence of death, disease progression, unacceptable toxicity, or     other specified withdrawal criterion.      Patients in control group can be provide pyrotinib treatment when they progressed after the     placebo plus capecitabine treatment.   "
23846|NCT02973724|"     The investigator designed this study to investigate remifentanil effect-site concentration in     95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol     anesthesia.   "
23847|NCT02973711|"     This study combines two drugs (ruxolitinib and the tyrosine kinase inhibitor, nilotinib) in     an attempt to eliminate the CML (Chronic Myeloid Leukemia) stem cell population and thus     allow for the deepest and most durable response possible in patients with CML in chronic     phase who have achieved a complete hematologic remission (CHR), complete cytogenetic     remission (CCyR), and major molecular remission (MMR), but not a complete molecular remission     (CMR). The study will look at safety and tolerability of ruxolitinib when combined with     nilotinib in a phase I study and will help establish the MTD (Maximum Tolerated Dose) of     ruxolitinib when combined with nilotinib. Once the optimal dose of ruxolitinib is established     in the phase I setting, a phase II evaluation will seek to establish the efficacy of this     combination.   "
23848|NCT02973698|"     Objective: To verify the effectiveness of chin-down posture maneuver in swallowing therapy     for Parkinson's disease (PD).   "
23849|NCT02973685|"     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion     chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with     large hepatocellular carcinoma staged BCLC A/B.   "
23850|NCT02973672|"     This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen     (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the     visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days     before surgery and visualized using an optimized camera system.   "
23851|NCT02973659|"     Primary focal hyperhidrosis interferes with daily activities. Limited efficacy, costs, side     effects and complications are issues of concern for most current therapeutic modalities. In     this study the invetigators aim to evaluate the efficacy of topical oxybutynin 10% gel in     treating primary focal hyperhidrosis. 60 patients with primary focal hyperhidrosis will be     recruited. Topical oxybutynin 10% gel will be assigned to the right or left axilla, palm or     sole and a placebo compound to the contralateral side for a total of 30 days. The     Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI)     questionnaires will be administered before and after treatment, and 2 noninvolved blinded     physicians will score the results using starch-iodine tests. The participants will grade the     sweat reduction on both sides and rated their satisfaction.   "
23852|NCT02973646|"     The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic     hepatitis b patients with e antigen positive based on the detection of interferon gene     mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.   "
23853|NCT02973633|"     The development of symptomatic heart failure is frequently preceded by a pre-clinical period     of structural remodeling in the heart. The remodeling process driving this transition,     however, remains poorly understood. The investigators hypothesize that imaging the diffusion     of water in the heart with MRI will allow its microstructure to be resolved. The     investigators further hypothesize that the characterization of microstructural changes in the     heart will help elucidate the pathogenesis of heart failure and the transition from a     compensated to a decompensated state. Patients with recent myocardial infarcts and left     ventricular hypertrophy, who are at risk for the development of heart failure, will be     enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the     heart to characterize changes in myocardial microstructure over time.   "
23854|NCT02973620|"     Open label study of levosimendan; planned comparison for effectiveness and safety to historic     matched case controls from participating sites.   "
23855|NCT02973607|"     Chronic kidney disease (CKD) is present in 1 in 7 of the population and confers a high risk     of cardiovascular disease. The pathophysiology of cardiovascular disease in CKD is poorly     understood because CKD is always accompanied by confounding factors including the underlying     disease process (e.g. diabetes mellitus, systemic vasculitis) and the consequences of CKD     including hypertension, anaemia and inflammation.      Nephrectomy in kidney donors causes a 30% reduction in renal function providing an ideal     study population to measure prospectively the effects of reduced kidney function on the     cardiovascular system.      The CRIB-Donor study (ClinicalTrials.gov Identifier:NCT01028703) demonstrated adverse effects     on cardiovascular structure and function at 12 months compared to controls including an     increase in left ventricular mass. This proposal will measure the changes in cardiovascular     structure and function, cardiovascular age and biochemical changes at 5 years providing     information on the long term effects of reduced renal function.   "
23866|NCT02973464|"     This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of     450mg daily begin within 10 days after renal transplantation, and till to Day 100     posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the     investigators divide these patients into three groups in random. One third will oral VGC     450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third     will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to     oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal     function for all agents.   "
23867|NCT02973451|"     to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site     Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.   "
32123|NCT02865304|"     The purpose of the present study was to prospectively evaluate the efficacy and safety of     endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2     negative metastatic breast cancer (MBC) patients.   "
23856|NCT02973594|"     Heart failure with reduced left ventricular ejection fraction (HFrEF) is the most common form     of chronic heart failure in subjects ≤ 75 years of age. Beta-blocker therapy greatly reduces     mortality and improves ventricular function in HFrEF patients, but 30-40% of patients do not     show improvement in ventricular function with beta blockade.      An extensive gene signaling network downstream from the beta1-adrenergic receptor, the     primary target of beta-blocker therapy is likely important for development and progression     HFrEF. Pathologic changes in this gene signaling network are only reversed towards normal     levels when ventricular function improves. One potential mechanism for failure to improve     ventricular function in HFrEF patients unresponsive to beta blocker therapy is a lack of     heart rate reduction.      Ivabradine is an FDA-approved medication believed to have therapeutic benefit in HFrEF     patients through reduction in heart rate independent of beta-blockade. Ivabradine has been     shown to reduce the risk of hospitalization for worsening HF in patients with stable,     symptomatic chronic heart failure with reduced EF (≤ 35%)in sinus rhythm with resting heart     rate ≥ 70 bpm and who are on maximally tolerated doses of beta blockers or who have a     contraindication to beta blockers.      Given the high rate of mortality and hospitalization of HFrEF patients even with current     therapies, there is a large unmet need for improving HFrEF therapy. The goals of this study     are to test the hypothesis that heart rate reduction is an important antecedent for     improvement in ventricular function, and to identify components of the beta1-adrenergic     receptor gene signaling network responsible for improvement in ventricular function caused by     heart rate reduction.   "
23857|NCT02973581|"     The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for     vitreoretineal surgery, presence of PONV and oculocardiac reflex and compare Numerical Rating     Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.      Patients received general anaestesia alone or combined with either preemptive analgesia using     topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2%     lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous     infusion of acetaminophen in a doseof 10-15mg/kg of body weight.   "
23858|NCT02973568|"     Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain     care with a consultations rate in emergency center of more than 60%.For example     OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.      In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France     (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies     relative to chronic pain but not too much about acute pain in Spain.That's why we want to     focus our study on evaluation of acute pain treatment and efficacy in french and spanish     hospital   "
23859|NCT02973555|"     Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome     of patients with thin endometrium undergoing ART treatments.   "
23860|NCT02973542|"     Abdominal pain remains the most deleterious symptom for patients with irritable bowel     syndrome (IBS) and is causing a significant alteration of their quality of life. The visceral     hypersensitivity seems to be one of the key mechanisms that could explain the abdominal pain     in these patients. Current treatments, mainly symptomatic, are of limited effectiveness,     especially in terms of relief of abdominal pain. The study will aim to evaluate the     effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its     impact on patient quality of life, severity of symptoms related to IBS and the use of     analgesics / antispasmodic / regulators transit.   "
23861|NCT02973529|"     Coronary artery disease is often treated by implantation of permanent metallic     stents.Coronary stents are required in the early healing phase after balloon dilatation but     constitute a lifelong foreign body. New bioresorbable stents have been developed and are     believed to improve long-term safety. The purpose of this study is to compare the safety and     vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable     stents Absorb and Desolve.   "
23862|NCT02973516|"     This study is an exploratory study aiming to collect data about diagnosis efficacy     (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with     suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC     confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology     analysis. The standard of reference for diagnosis will be given by the site according to     their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous     contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site     and/or the more recent AFP results available).   "
23930|NCT02972645|"     The purpose of this study is to evaluate the safety of LY3305677 and any side effects that     might be associated with it.      This study will also look at how much LY3305677 gets into the blood stream, how long it takes     the body to remove it.      This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).      Participation in this study is expected to last up to 16 weeks.   "
23931|NCT02972632|"     The purpose of this study is to determine the effectiveness of treatment with vortioxetine on     participant goal achievement after a change in antidepressant medication for the treatment of     major depressive disorder (MDD).   "
26092|NCT02944162|"     The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in     treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem     cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.   "
23863|NCT02973503|"     A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of     Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected     Patients, with non-severe fibrosis      The primary objectives of this study are as follows:        -  To evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks          in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by          the proportion of subjects with sustained viral response 12 weeks after cessation of          treatment (SVR 12).        -  To evaluate the safety and tolerability of EBV/GZR treatment      The secondary objectives of this study are as follows:        -  To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation          of treatment (SVR4 and SVR24)        -  To evaluate the proportion of subjects with virologic failure        -  To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of          treatment.        -  To evaluate the emergence of viral resistance to EBV/GZR during treatment and after          cessation of treatment   "
23864|NCT02973490|"     We design the clincal trial to investigate the efficacy of transanal tube drainage in     colorectal ESD.   "
23865|NCT02973477|"     The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes     medication, on measures of nervous system function of the heart in patients with type 2     diabetes. The investigators will compare the effect of dapagliflozin with an active     comparator, glimepiride (a different FDA approved diabetes medication) on measures of heart     rate variability and assess whether dapagliflozin has modulating effects on measures of     nervous system function of the heart. This is a crossover study design where all participants     will receive both study medications equally (12-week intervention periods) in a certain     order.   "
23869|NCT02973425|"     Take a Break (TAB) is a randomized trial designed to evaluate NRT-sampling and a mHealth     suite of apps. TAB is a time-limited self-efficacy and skills building experience for     Motivation Phase smokers. TAB is designed to create a timeline within which motivation     smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation     Phase are relatively untapped in research available information. This project offers these     smokers point-of-need technology support in the many components of the intervention.   "
23870|NCT02973412|"     The aim of this study is to explore the associations between chronotype and glycaemic     control, cardiometabolic health and other lifestyle factors.   "
23871|NCT02973399|"     SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of     the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome     ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the     addition of SNX-5422 to an established dose of ibrutinib will provide clinical response in     subjects who have residual disease, but have not progressed on ibrutinib after 18 months of     monotherapy, and/or prevents or delays disease progression of subjects with CLL.   "
23872|NCT02973386|"     This is a randomized,controlled,prospective phase III clinical trial. The purpose of this     study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with     or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma     at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan     which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques     for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.   "
23873|NCT02973373|"     The purpose of the study is to evaluate the benefit on image quality of MRI of the chest     performed under high frequency non-invasive ventilation. This technique indeed allows to     generate an apnea duration of several minutes with acquisitions performed at full     inspiration. This study will be applied on healthy subjects.   "
23874|NCT02973360|"     This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-finding     study of SC411 in children with sickle cell disease (SCD). The primary objective of the study     is to evaluate the safety and tolerability of three different doses of SC411 compared to a     placebo. All patients will undergo eight weeks of oral study treatment and a four-week safety     follow-up period. Patients will be randomized to one of three dose levels of SC411 or     placebo.   "
23875|NCT02973347|"     Mechanical ventilation has become one of the most important supportive treatment methods to     save the life of critically ill children over time. Ventilator-associated pneumonia (VAP) is     a common complication of mechanical ventilation. It is one of the leading causes of     hospital-acquired infections in the Paediatric Intensive Care Unit (PICU).VAP can aggravate     patients' condition and have adverse effect on mechanical ventilation. Moreover, VAP is     associated with significant increased mortality. In those critical ill patients, the     catabolism increased, the anabolism decreased, which can induce negative nitrogen balance.     The consensus of optimal nutrition therapy in pediatric critical care in the Asia-Pacific,     released in 2014, clearly recommended that early enteral nutrition support, which begin     within 24-48 hours after admitting in PICU, can significantly reduce the prevalence and     mortality of nosocomial infection. Intermittent enteral feeding and continual enteral feeding     are the most common methods of enteral nutrition at present. There is no final conclusion     about the association between enteral nutrition methods and VAP. Thus, the relationship     between enteral feeding and VAP has long been a controversial issue. There is little clinical     research on the correlation between enteral nutrition and VAP in children with mechanical     ventilation, and mostly were observational studies which lacks strong evidence. How to choose     the appropriate enteral nutrition remains an urgent need in PICU clinical work. Therefore, it     is necessary for us to analyze the relationship between enteral feeding and VAP in critically     ill children. This study would perform a two-year research with mechanical ventilated     patients in PICU of four children hospitals in Shanghai, which aim to determine the     relationship between different enteral feeding methods and VAP, to collect the baseline     characteristic data of ventilated children, to analyze the risk factors for VAP in PICU     patients. The results from our study would contribute to improving the standard of care for     children undergoing mechanical ventilation, reducing their lung injury and improving     prognosis.   "
23876|NCT02973334|"     This exploratory study aims at investigating the acute effects of artificially sweetened and     sugar beverage consumption (as compared to water consumption) on acute hemodynamic and     metabolic stress response.   "
23961|NCT02972242|"     Coronary computed tomography angiography (CCTA) is a frequently performed test for the     diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected     patients. The performance of non-contrast computed tomography for the detection and     quantification of coronary calcification is typically performed prior to CCTA in an effort to     identify significant calcification which may influence subsequent data acquisition during the     CCTA. However, performance of calcium scoring adds significant radiation and most coronary     calcification is proximal in its location, potentially visualized using a focused     non-contrast scan.      The purpose of this study is to prospectively compare the usefulness of a modified     non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as     compared to standard coronary artery calcium scanning for the detection of coronary     calcification that may influence subsequent CCTA performance.   "
23877|NCT02973321|"     Primary Objective:      The primary objective of this study is to assess the dose-response relationship of SAR425899     versus placebo in terms of glycemic control as measured by the change in glycosylated     hemoglobin (HbA1c).      Secondary Objectives:        -  To assess the effect of SAR425899 on body weight.        -  To assess the safety and immunogenicity profile of SAR425899, including assessment of          the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.        -  To assess the proportion of patients achieving predefined HbA1c targets of <7% and <6.5%          as well as the proportion of patients achieving ≥5% and ≥10% body weight loss.        -  To assess the effect of once daily dosing of SAR425899 on additional parameters of          glycemic control and lipid metabolism.        -  To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic          (PD) biomarkers.        -  To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual          and inter-occasion variability in PK parameters using a population PK approach.   "
23878|NCT02973308|"     Exercise testing is commonly being used in patients before surgery to test their overall     fitness. One group it is being used in is patients who have an enlarged blood vessel in their     stomach. This is known as an abdominal aortic aneurysm. The exercise test used is known as a     cardiopulmonary exercise test as it looks at both heart and lung function at the same time.     Whilst this test is commonly used there have been no studies (to date) which have looked at     how reliable this test is; this means how well the investigators can obtain the same (or very     similar) results after multiple tests. The investigators would like to test this reliability     both between patients and the clinicians performing the testing.   "
23879|NCT02973295|"     This study evaluates the influence of Silymarin in reducing laboratory, ultrasonographic     (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive Silymarin     (Verum) while the other half will receive placebo   "
23880|NCT02973282|"     The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software     application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis,     asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in     infants and children. Patient's cough sounds will be recorded using a smartphone and analysed     using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis     and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or     patient.   "
23881|NCT02973269|"     The specific aim of the study is to compare the safety and efficacy of a single     administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar     fasciitis.   "
23882|NCT02973256|"     Meningiomas with malignant components include grade II meningiomas (GIIM, the most common     ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas.     Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as     being quite subjective. Standards of care and consensus do not exist for GIIM, particularly     in regards to performing, or not, radiotherapy after surgery. One other limitation in the     literature is lack of data on health-related quality of life (HRQoL). Clinical trials for     GIIM are very difficult to conduct. No results have been made available. Here, we propose to     study clinical, pathological, radiological and therapeutic factors of an exhaustive     population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to     assess the impact of postoperative radiotherapy, or the absence of postoperative     radiotherapy, on overall survival and on quality of life   "
23883|NCT02973243|"     To evaluate the effect of automated recording on frequency of recorded scores, number of     automated notifications and serious events.   "
23884|NCT02973230|"     The aim of the present study was (i) to evaluate whether a single measurement of VEGF would     allow us to distinguish between intrauterine pregnancy (normal and abnormal) and EP and (ii)     to correlate the levels of VEGF with serum levels of progesterone and β-hCG in each subgroup.      Ninety patients were selected from a population of women presenting to the Hospital das     Clínicas of the University of São Paulo Medical School from October 2006 until September 2007     and were divided in three subgroups: (i) abnormal (arrested) intrauterine pregnancy (defined     as a gestational sac greater than 16 mm of mean diameter without fetal tissue or a embryo     greater than 5 mm without embryo cardiac activity); (ii) tubal pregnancy (no evidence of     intrauterine pregnancy, presence of a adnexal mass, suboptimal rise of serum hCG levels in 48     hours); all tubal pregnancies were surgically treated and were histologically confirmed, they     did not receive any methotrexate treatment before operation; (iii) normal intrauterine     pregnancy (intrauterine gestational sac, embryo vitality confirmed).      Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of     blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations).     Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at     room temperature for 2-6 hours.   "
23885|NCT02973217|"     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a     tumor specific immunologic response. In laboratory animals the imILT method has also been     shown to induce a so called abscopal effect. This means that when one tumor is treated with     imILT other, untreated, tumors also decrease in size.      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction     of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is     also to investigate the functionality and safety as well as understanding of the subsequent     immunological effects.      This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic     cancer will be treated in this trial, which is estimated to be carried out during a time     period of 36 months.   "
23962|NCT02972229|"     To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy     for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic     spinal tumors   "
23963|NCT02972216|"     A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of     Docetaxel-Based Chemotherapy   "
24201|NCT02968888|"     The aim of this study is to investigate the acute anabolic effects of native whey, whey     protein concentrate 80 (WPC-80) and milk after a bout of strength training in young and     elderly. The investigators hypothesize that native whey will give a greater stimulation of     muscle protein synthesis and intracellular anabolic signaling than WPC-80, and that WPC-80     will give a stronger stimulus than milk.   "
23886|NCT02973204|"     Background Treatment and control of cancer is associated with high costs, to patients in the     form of side effects and discomfort during investigations, to society in the form of     expensive drugs and studies.      Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to     estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC     is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to     metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the     analysis of the CTC.      The investigators would like to with molecular biological methods predict which patients     requires special monitoring and individualized therapy and explore these tests as clinical     decision support.      Purpose and method      In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma     (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and     digital polymerase chain reaction (PCR):        1. Identify and isolate the CTC and investigate these for tumor-specific mutations.        2. Quantify ctDNA and analyze this for specific mutations, which in the past has been found          frequent in NET and HCC.        3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies.      The results are compared with the clinical data on disease course, including the effect of     treatment and survival.      Subjects 40 Patients with small intestinal/unknown primary NET before treatment with     somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30     patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib     A blood sample will be taken prior to the start of treatment, after 1 month after start of     treatment and thereafter every 3.-6. month for up to two years.      Perspectives In several cancer types molecular diagnostics have had significant influence in     treatment and control strategy. The goal is in future to be able to take advantage of a     so-called liquid biopsy as clinical decision support. The study will bring new knowledge to     this growing field of research.   "
23887|NCT02973191|"     This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and     safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential     parts, Part A and Part B; subjects will be screened and will provide informed consent before     initiating any study procedures in Part A of the study.   "
23888|NCT02973178|"     This study will test Scanadu Urine Device for clinical performance and usability.   "
23889|NCT02973152|"     The purpose of this study is to help determine the most effective treatment for participants     with Unilateral Vocal Fold Paralysis.      There are currently two types of operations used to treat this condition. One operation is     called thyroplasty. Doctors place a small piece of safe plastic into the side of the     participant's voice box to push the weak vocal cord into a position to enable better speech     and swallowing. In the other operation called laryngeal reinnervation, doctors repair the     neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better     speech and swallowing. The investigators do not know which of these methods is better and are     conducting this study to start comparing the two operations so that a larger clinical trial     can be conducted in the future to tell us which operation is best.   "
23890|NCT02973139|"     The purpose of this prospective randomized clinical trial is to compare two currently     accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to     instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant     Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion     (CPPE) in adults.   "
23891|NCT02973126|"     The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in     identifying vessel-specific, hemodynamically significant CAD in patients scheduled for     invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In     particular, the study will evaluate the ability of FFRct to correctly rule out     hemodynamically significant CAD in patients with non-significant CAD or normal coronary     arteries who had positive SPECT scans.   "
23892|NCT02973113|"     Subjects have a type of a lymph node cancer called Non-Hodgkin's Lymphoma (NHL) or     lymphoproliferative disease (LPD), which affects their immunity, blood production, and can     involve multiple other organs in the body. Their disease has come back or has not gone away     after treatment. The experimental treatment plan consists of an antibody therapy called     Nivolumab that helps the subjects' T-cells control the tumor, and special immune system     cells called LMP-specific cytotoxic T lymphocytes, also a new therapy whose side effects are     well studied.      Some patients with NHL or LPD are infected with the virus that causes infectious     mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis.     The cancer cells that are infected by EBV are able to hide from the body's immune system and     escape destruction. Investigators want to see if special white blood cells, called T cells,     that have been trained to kill cells infected by EBV can survive in the blood and affect the     tumor.      Investigators have used this sort of therapy to treat a different type of cancer that occurs     after bone marrow or solid organ transplant called post-transplant lymphoma with good     success. These cells are called LMP-specific cytotoxic T-lymphocytes (EB-VSTs), and are     effective in treating these diseases. These LMP-specific EB-VSTs are experimental and not yet     approved by the Food and Drug Administration (FDA).      Sometimes it is not possible to grow these cells; or they may not last very long in the body     after being given into the vein thereby having only limited time to fight the tumor. With     this study, investigators aim to increase the duration of time that the T cells can last in     the body and can effectively fight the cancer by using nivolumab. Nivolumab is FDA approved     for treatment of other kinds of cancer like lung cancer and a skin cancer called Melanoma.      The purpose of this study is to find out if LMP-specific EB-VST cells in combination with     nivolumab are safe, to learn what the side effects are, and to see whether this therapy may     help patients with EBV related lymphoma or LPD.   "
23893|NCT02973100|"     The purpose of this study is to evaluate the efficacy and safety of investigational doses of     dulaglutide in participants with type 2 diabetes on metformin monotherapy.   "
23894|NCT02973087|"     The purpose of this phase 3 study is to investigate the efficacy and safety, including     immunogenicity and thrombogenicity of prophylactic treatment with recombinant von Willebrand     factor (rVWF) in subjects with severe von Willebrand disease (VWD).   "
23895|NCT02973074|"     The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in     the course of Patient Blood Management in preparation for orthopedic surgery.   "
23896|NCT02973061|"     Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit     and hyperactivity charachteristics in children and adolescents. This will be examined in     children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated     questionnaires (Vanderbilt rating scales) evaluating ADHD.      Data will be compared to healthy control group.   "
23897|NCT02973048|"     Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia     using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite     effective surgical anesthesia, bupivacaine is associated with long duration motor block and     dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its     new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and     faster regression of motor block compared to other local anesthetics without noteworthy     side-effects when used intrathecally. The aim of this randomized, multicenter, powered     clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric     bupivacaine for scheduled caesarean delivery under spinal anesthesia.   "
24202|NCT02968875|"     Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common     forms of dementia in humans and memory disorder is one of the first symptoms that lead to     diagnosis.   "
23898|NCT02973035|"     Hypertensive patients are at increased risk of developing LV hypertrophy and myocardial     fibrosis, which cause diastolic dysfunction. Because the activation of     rennin-angiotensin-aldosterone system (RAAS) has been shown to induce LV hypertrophy and     myocardial fibrosis, the RAAS may play a central role in the pathogenic process from     hypertension to diastolic HF. Inhibitors of RAAS have been considered as a treatment option     for these patients, and the angiotensin receptor blockers (ARB) have been of interest because     they antagonize the effects of angiotensin II more completely. However, the Irbesartan in     Heart Failure with Preserved Systolic Function (I-PRESERVE) trial reported that treatment     with irbesartan did not reduce the risk of death or hospitalization for cardiovascular causes     among 4,128 patients who had HF with a preserved LV ejection fraction. The degree of     improvement of diastolic dysfunction was associated with the extent of systolic blood     pressure reduction, whether a RAAS inhibitor or non-RAAS blood pressure lowering was used.     Amlodipine is a potent and well-tolerated calcium channel blocker, and seems to be     appropriate for achieving more aggressive systolic blood pressure target and improving     diastolic dysfunction in hypertensive patients, because amlodipine is clinically very useful     for controlling systolic blood pressure. Assessment of diastolic function by echocardiography     will be helpful to determine whether addition of amlodipine or an ARB to standard therapy is     more beneficial to hypertensive patients with diastolic dysfunction. The investigators     hypothesize that amlodipine added to standard therapy will be superior to valsartan in     improving diastolic dysfunction by lowering systolic blood pressure more effectively in     hypertensive patients, and try to examine this hypothesis in a prospective, open-label,     randomized comparison study using blinded echocardiographic evaluation for end point.   "
23899|NCT02973022|"     The aim of this study is to evaluate the impact of participation in Cancer Clear and Simple     (CC&S) educational sessions on cancer prevention and screening. The researchers will recruit     60 community members: 30 will receive CC&S training (intervention group) and 30 will not     (control group). All 60 will be surveyed about their intent to change their behavior at the     beginning of the study and their actual behavior changes and their screening behavior 6     months after enrollment in the study.   "
23900|NCT02973009|"     The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic     booming in recent years.      This is an effective intervention on weight loss over the long term with few early     postoperative complications and low morbidity in the long term.      Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a     relative risk of 29% in connection with cholecystectomy.      Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical     evaluation.      Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric     bypass with a rupture rate increased on epigastric trocar. The assessment in the context of     this series was ultrasound.      Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an     SG of first intention was associated with a hernia rate of 17% with a scannographic     evaluation.      Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site     would not be as effective as lateralize inserting the trocar from the white line of the     abdomen. Change the positioning of this trocar induce an additional difficulty in handling     instruments for the realization of the SG with an désaxassion instruments, a conflict between     the instruments for the realization of the SG and the optical laparoscopy.   "
23901|NCT02972996|"     Lifestyle strategies that include dietary modification, such as consumption of a plant-based     diet, are well recognized in disease prevention and may improve type 2 diabetes. Various     components of a plant-based diet may contribute to its beneficial health effects, but there     has been keen interest in the possibility that plant polyphenols may have a role. Blueberries     are dietary sources of polyphenols, specifically anthocyanins. To date there are few human     clinical trials evaluating the beneficial health effects of blueberries in populations with     type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries     compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2     diabetes.   "
23904|NCT02972957|"     The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given     into the nose and in early studies was shown to be better than the standard influenza vaccine     at preventing infections in children. However, more recently, it has performed less well and     it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why     this is, but the investigators also do not fully understand why LAIV produces stronger nasal     antibody responses in some individuals but not others. Usually harmless bacteria that are     present in participants noses can influence how our immune system works and variations in     these may explain differences in how LAIV works. The project will recruit children given LAIV     in the Gambia to gain further understanding of these issues.      The investigators will measure a variety of responses to LAIV, including genes that can     change their expression early after vaccination and use advanced computational techniques to     identify new relationships between these genes and other LAIV responses. The investigators     will also see whether nasal bacterial profiles in children who respond to LAIV are different     from those who do not. In addition, the investigators will alter these bacteria in a subset     of children with antibiotics and see whether this affects both nasal gene expression and     later responses to LAIV.   "
23905|NCT02972944|"     Laparoscopic cholecystectomy is the only curative treatment for gallstone disease of acute     calculous cholecystitis.The purpose of this study is to find the most effective treatment     (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute     cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering     from acute cholecystitis is performed.   "
23906|NCT02972931|"     The main purpose of this study is to unravel the mechanisms by which the Low Viral Reservoir     Treated patients (LoViReT) maintain extremely low HIV-1 DNA levels despite having initiated     cART during chronic HIV-1 infection. This group may have specific and different clinical,     virological and immunogenetical characteristics, compared to patients with regular reservoir     size, which might be useful to design new and more effective treatment approaches.   "
23907|NCT02972918|"     The purpose of this study is to evaluate whether preoperative optimization with levosimendan     in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue     perfusion parameters.   "
23964|NCT02972203|"     Specific aims for this pilot study are:      (Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of     an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a     60-minute introduction to mindfulness plus referral to community resources on measures     related to anxiety, depression, and stress, and self-management of chronic illness.      (Medical Regimen Adherence Aim): Among primary care patients, compare the effectiveness of     MTPC vs. 60-minute introduction to mindfulness on the initiation and maintenance of an action     plan.      (Patient-Provider Relationship Aim): To examine the effects of level of primary care provider     mindfulness training on successful referral to program, patient-provider relationship     measures, and on patient action plan initiation and maintenance.   "
23908|NCT02972905|"     GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase (PI3K) delta     inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment     of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD). The     purpose of the study is to assess the safety, tolerability and pharmacokinetics (PK) of     single and repeat doses of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI)     to healthy Japanese subjects. This is the first time for Japanese subjects that GSK2269557     will be administered via the ELLIPTA DPI with the addition of magnesium stearate.      In each group of this study, subjects will receive a single dose of either GSK2269557 or     placebo in Session 1 and receive daily dose of GSK2269557 or placebo for 10 days in Session     2. Session 1 of the next dose strength may be run in parallel with the Session 2 of the     previous dose. The doses planned for the study are 200 micrograms (mcg), 500 mcg and 700 mcg.     There will be at least 10 days washout between the two dosing sessions. Follow up period will     start 10 days (+-1 day) after the last dose of Session 2. A total number of 36 subjects will     be enrolled for the study with 27 subjects receiving a dose strength of GSK2269557 and 9     subjects will receive each dose strength of GSK2269557. ELLIPTA is a trademark of the GSK     group of companies.   "
23909|NCT02971670|"     Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from     the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible     for almost all of menstruation associated and more than 50% of all other cases. There is no     specific therapy. The Phase I study BioMed0713 demonstrated the safety and tolerability of     the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy     adults.      The aim of this amendment is to demonstrate prolonged safety of the BioMed rTSST-1 Variant     Vaccine and to assess persistence of antibodies generated in participants. The second aim of     the study is to assess boosterability of the BioMed rTSST-1 Variant Vaccine.   "
23910|NCT02971657|"     This was a prospective study performed between November 2011 and September 2013. Patients     with a confirmed S. aureus infection after fracture fixation or prosthetic joint infection     were included. Exclusion criteria included infections involving external fixation pins,     infections without any implanted hardware and culture positive patients not displaying any     clinical sign of infection. The following surgical parameters were documented: affected bone     or joint; type of implant; time between implantation of the device and onset of symptoms.     Personal characteristics and patients`health status were also documented. Any revision     surgeries involving the site of interest and all isolated pathogens were recorded throughout     the course of treatment and follow-up.      A follow up examination was performed an average of 23 months after discharge. Primary     outcome at follow up was cure. Cure was defined by the authors as: missing local (at site of     interest) or systemic signs of infection, terminated surgical and systemic therapy and     restoration of joint or limb function.      At the first surgical procedure after enrolment, at least four deep bone biopsies were taken     from the interface between implant and affected bone. Identification and antibiotic     susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined     according to the definitions of the European Committee of Antimicrobial Susceptibility     Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays     according to protocol of Stepanovic et al.(see references).   "
23911|NCT02971644|"     To investigate whether implantation of cobalt alloy pedicle screws is effective in treating     severe kyphosis deformity in spinal tuberculosis, and to determine the factors that are     likely to have influenced the curative effects.   "
23912|NCT02972879|"     The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin,     ultrasound and orthotics) versus corticosteroid injection for trigger finger.   "
23913|NCT02972866|"     This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral     Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients     will receive Astrazeneca medication. There is no placebo group.   "
23914|NCT02972853|"     The purpose of this study is to 1) determine whether Mindfulness Training for Primary Care     (see study MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A     Pilot Study) improves chronic disease management and 2) changes brain activation in     neuroimaging tasks before compared to after the training. Neuroimaging fMRI tasks probe     mechanisms related to self-regulation, such as attention/inhibition, emotion regulation,     self-compassion, interoception and pain regulation.      The study will also look at whether successful chronic disease management relates to the     observed brain activation changes after compared to before the mindfulness intervention.   "
23915|NCT02972840|"     This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and     rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle     cell lymphoma.   "
23916|NCT02972827|"     Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards     FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in     sepsis and septic shock.   "
23917|NCT02972814|"     The investigators prospectively want to compare 3 clinical tests for measuring blood troponin     levels in patients presenting to the emergency room with thoracic pain probably related to a     myocardial infarction with regard to the time necessary to obtain the test results.      The tests are one laboratory based test and two point of care tests.   "
23918|NCT02972801|"     Testicular tissue cryopreservation is an experimental procedure where a young boy's     testicular tissue is retrieved and frozen. This technique is reserved for young male patients     who are not yet producing mature sperm, with the ultimate goal that their tissue may be used     in the future to restore fertility when experimental techniques emerge from the research     pipeline.   "
23919|NCT02972788|"     The purpose of the study is to determine the effect of enamel matrix protein derivative on an     inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix     derivative protein with increase the clinical attachment level is localized sites of advanced     periodontal disease.   "
23920|NCT02972775|"     The investigators examine the 15-year mortality after an admission for an exacerbation of     Chronic Obstructive Pulmonary disease (COPD).   "
28206|NCT02916485|"     Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting     Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary     artery lesions.   "
23921|NCT02972762|"     The investigators,according to the eligibility criteria,plane to choose 80 elderly     anticipates who will undergo selective hip replacement surgery.This participants will be     randomly divided into 2 groups:light anesthesia depth group(L Group) and deep anesthesia     depth group (D Group).Before anesthesia induction,each participant will be given lumbar     plexus and sciatic nerve block in order to control pain of interoperative and     postoperative.During operation period,the L Group will be kept in light anesthesia     depth(BIS:50-60),while the D group will be kept in deep anesthesia depth(BIS:35-45)--The BIS     values in the range of 30-60 have been recommended in general anesthesia.After operation,a     PCIA(patient controlled intravenous analgesia) analgesia pump will be given to each     participant to control postoperative pain. The investigator will evaluate the mental state of     participant with MMSE(mini-mental state examination) before surgery and review each     participant with a CAM-CR for 3 days after surgery to assess the situation of postoperation     delirium.intraoperative awareness,postoperative pain will also be investigated in     postoperative days 1, 2, 3.   "
23922|NCT02972749|"     There is growing awareness that environmental factors, behaviors and diet are intimately     related to patient health and may play a role in the pathogenesis and progression of     glaucoma. Evidence from recent years has shown that some behaviors and environmental factors     can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims to     investigate whether simple and common lifestyle inteventions such as sleeping with a head     elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake     could affect intraocular pressure and other outcomes.   "
23923|NCT02972736|"     Retrospective multicenter study aimed to evaluate radiation exposure associated with     different interventional procedures involving interventional cardiologists, interventional     radiologists and electrophysiologists.   "
23924|NCT02972723|"     Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease     worldwide. Current therapy for HCV with interferon based therapies results in cure rates of     around 5055% which leaves a significant number of patients without effective therapy. HCV     induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce     the response to antiHCV therapy. This finding stimulated initial studies looking at agents     that may reduce insulin resistance as additional therapy in HCV infection.      A study using metformin in addition to interferon and ribavirin showed a nonsignificant     increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection     AND demonstrable insulin resistance. The assumption was made that the potential effect of     metformin was likely to be on insulin resistance and thus by modulating this enhances     response. The investigators (Prof M Harris, University of Leeds) have data (currently     unpublished)suggesting that metformin may have an antiviral effect independent of its effect     on insulin resistance, thus raising the possibility that metformin may have a direct     antiviral effect in vivo. Given that the development of specific antiHCV agents which target     viral proteins such as its polymerase and protease are in trial development but have so far     proved either highly toxic or are likely to have a huge cost there is considerable rationale     for looking at alternative potential antiHCV agents and in this context metformin is cheap,     readily available and has an excellent safety profile. This pilot study therefore addresses     the question Does metformin therapy result in a significant drop in HCV viral load in     chronically infected patients?   "
23925|NCT02972710|"     The purpose of this study is to compare the short-term effects of two different thoracic     spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported     disability in individuals experiencing neck pain.   "
23926|NCT02972697|"     Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis     (TB) may be able to detect non-replicating persister bacilli. This may permit identification     of those patients at risk of relapse following completion of TB treatment. The main aim of     this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in     individuals with active pulmonary TB.   "
24214|NCT02968719|"     A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate     the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil     Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy     Adult Subjects   "
23927|NCT02972684|"     Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac     surgical interventions.      Treatment of such complication often necessitates various combinations therapeutic     intervention including allogenic blood products administration, drug use and/or surgical     intervention. All are expensive treatment and decision making is guided by patient clinical     status and biological tests of the haemostatic function.      A key point is the time frame of the clinical process. Therapeutic choices have to be done as     fast as possible to minimize bleeding consequences on patient haemodynamic and physiological     status. Conventional coagulation test results availability time usually exceed 45' after     blood drawing. In such situation, the results may not reflect precisely the coagulation     system current state. This downside is often counterbalanced by clinicians empirical choices     preceding lab test results knowledge that may conduct to inappropriate treatment, blood     product overuse and undue expense.      Viscoelastic point of care test may compensate for the limitations of conventional     coagulation tests. In perioperative haemorrhage, faster and more precise information about     haemostatic function may help for more accurate therapeutic choices.      The IMOTEC study aims to compare haemorrhage management following cardiac surgery using     conventional blood coagulation tests or thrombo-elastogaphic point of care test.      Primary endpoint is a cost utility analysis of the technology and secondary endpoints include     blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative     infection (any cause), organ failure, in hospital length of stay and death.   "
23928|NCT02972671|"     To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at     12 months in a non-inferiority trial in a real world patient population and to confirm that     the domestic extrapolation of the DESSOLVE III study results is valid.   "
23929|NCT02972658|"     This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The     purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in     participants with early Alzheimer's disease dementia at the time of entry into study     I8D-MC-AZES.   "
23932|NCT02972619|"     Background: Hypertension is a serious public health problem responsible for significant     mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30 years     or older suffer from hypertension. Nearly half of these patients have uncontrolled     hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims to     evaluate the effectiveness, cost effectiveness and impact on medication adherence of a     well-structured program using multicomponent intervention for hypertension control aimed at     overall cardiovascular risk reduction among individuals with hypertension attending the     polyclinics in Singapore, compared to existing services. Such a program is expected to be     cost-effective in terms of improving hypertensive individuals' outcomes, and to be     potentially scalable and sustainable.      Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized     to intervention or usual care (4 each) and followed up for 2 years post randomization      Intervention: The structured multicomponent primary care program comprises of: 1)     algorithm-driven antihypertensive treatment for all hypertensive individuals and using     fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive     individuals, 2) motivational conversation for high-risk hypertensive individuals, 3)     Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary     outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on FDC     antihypertensive medication      Usual care: The participants attending polyclinics randomized to usual care will continue to     receive treatment from the health providers according to existing practices. The hypertensive     individuals will also continue to pay for the services (physician or nurse consultation) as     per their existing model of reimbursement.      Participants: A total of 1000 participants will be recruited, 125 from each of the 8     polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by     randomization group).      Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors     independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary     outcome will be the change in systolic blood pressure from baseline to 2 years. Primary     Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction from     baseline to end of follow-up at two years post randomization; 2) incremental cost per     projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years     (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline     to final follow-up at two-year post. The impact of effect on adherence to antihypertensive     and lipid medication will be measured using data on adherence obtained from polyclinic     pharmacy records and clinic notes. An average of percent adherence to antihypertensive and     lipid lowering will be computed as a composite score. The change in percent composite     adherence to antihypertensive and lipid medications from baseline to follow up will be     compared between the intervention and control groups.   "
23933|NCT02972606|"     Presently, there are few options for medically managing HIV-related painful peripheral     sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural     Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN.     However, there is a scarcity of research on psychological treatment approaches for pain     management in people with HIV. This study will use in-depth semi-structured interviews to     examine the needs of people with painful HIV-SN for a psychologically-based pain management     treatment that may be delivered over the Internet. Interview questions will examine     participants' needs in terms of treatment content and delivery format. Men and women, ethnic     minorities, and people who use recreational drugs will be sampled to ensure that interview     responses reflect the views of people most commonly suffering from this condition.     Approximately 30 people will be recruited for the study. The interviews will be audio     recorded, transcribed verbatim, and coded to identify themes. The interview responses will be     used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that     tailoring the treatment based on the qualitative interview responses will increase the     acceptability of the treatment and will improve treatment adherence rates for a future study.   "
23934|NCT02972593|"     The purpose of this study is to determine if there is a difference in outcomes between     liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and     conservative transfusion (transfusing when hemoglobin drops below a set lower value number).   "
23935|NCT02972580|"     Longitudinal prospective observational study. This is a 24-month study with the possibility     of extending the data time points. Initially baseline, then 12 and 24 months follow up     studies will be completed.   "
23936|NCT02972567|"     The purpose of this study is the evaluation of the effects in obese patients with metabolic     syndrome on the composition of the intestinal microbiota, markers of the syndrome     (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic     steatosis) and other possible metabolites involved.   "
24215|NCT02968706|"     The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to     conventional nasal cannula, improves oxygenation and prevents desaturation events in obese     patients undergoing colonoscopy.   "
23937|NCT02972554|"     This randomized, double-blind, placebo-controlled study of propranolol will shed important     light on how sympathetic nervous system (SNS) activation influences our psychological and     inflammatory responses to acute stress. Results from this study will inform both the basic     science literature that is attempting to map the physiological mechanisms by which     psychological stress may lead to poor mental and physical health, and may also ultimately     have therapeutic relevance for individuals who are experiencing high levels of stress that is     putting their health at risk. By utilizing psychopharmacological approaches, the     investigators will circumvent many of the challenges of conducting this research in human     populations. The investigators will also be in a place to draw strong conclusions regarding     causality, given that they will have experimentally manipulated SNS activation, rather than     relying on correlational measures of SNS activity that are difficult to assess and are not     appropriate for asking if SNS activity causes changes in psychology and biology.   "
23938|NCT02972541|"     Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with     colorectal cancer present with an emergency obstruction of the large bowel at the time of     diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients with     obstruction are associated with worse oncologic outcomes compared with those having     nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction     receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and     about two-thirds of such patients end up with a permanent stoma.      Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve     obstruction prior to elective surgery) in patients with potentially resectable colorectal     cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior     to emergency surgery considering the short-term outcomes. SEMS is associated with lower     morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma     creation rate. Although about half of patients can achieve primary anastomosis after stent     placement, the primary anastomosis rate is still significantly lower compared with     nonobstructing elective surgery. The interval between stent placement and surgery may be not     long enough that bowel decompression is insufficient at the time of operation.     Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still     limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with     SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was     significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation     is that tumor cells may disseminate during the procedure of colonic stenting placement. We     hypothesis that immediate chemotherapy after stenting may improve overall survival by     eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the interval between     stent placement and surgery, and the time for bowel decompression is more sufficient, which     may increase the success rate of primary anastomosis and decrease risk of stoma formation.   "
23939|NCT02972528|"     Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed     with Diabetic Foot Ulcer (DFU).   "
23965|NCT02972190|"     Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads     to potential adverse consequences associated with extensive disruption of posterior bony and     soft-tissue structures. The investigators plan to compare the clinical and radiographic     outcomes of bilateral decompression with transforaminal lumbar interbody fusion and     laminectomy with posterior lumbar interbody fusion in the treatment of degenerative     spondylolisthesis.   "
23940|NCT02972515|"     Tobacco use among women now approaches that of men, with approximately 27 million women     smokers in the United States alone. Women report greater difficulties quitting smoking and     are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary     practices and lack of physical activity, with 92% of smokers reporting at least one other     health risk factor. Concerns surrounding weight gain, negative body image, and low     self-efficacy, may be key factors affecting smoking cessation among weight-concerned women     smokers. Guided imagery has been successfully employed in separate lines of inquiry to     address physical activity, diet and smoking cessation. However, guided imagery has not been     employed to target weight concerned women who smoke or to simultaneously target smoking,     diet, and exercise behavior in a single intervention. The proposed study would be the first     of its kind to create a theory-based, guided imagery intervention to assist weight-concerned     women smokers to quit. The use of a mobile app offers an innovative approach to addressing     the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and     has the potential to reach large numbers of women smokers. The project aims to develop and     test the feasibility of a mobile health application using guided imagery in order to increase     smoking cessation among a population of weight-concerned women smokers.   "
23941|NCT02972502|"     Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency     department (ED).In this study the investigators seek to explore another option for treatment     of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol),     a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor     in the brain.      By exploring haloperidol as an option for treatment, the investigators hope to discover a     more efficient and effective medication for the treatment of non-traumatic headaches, thereby     decreasing a patient's length of stay in the department and decreasing the rate of return     visits for continued discomfort from the same headache. This study could lead to the     increased usage of haloperidol as a first line agent in the treatment of prolonged headaches     presenting to the ED.   "
23942|NCT02972489|"     The primary purpose of this study is to determine whether bifurcation stenting guided by     on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with     angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation     segment.   "
23943|NCT02972476|"     A randomised controlled trial to test the hypothesis that inhaled therapies for chronic     obstructive pulmonary disease (COPD) have differential effects on the upper airway     microbiome.      COPD is the third leading cause of death worldwide. Exacerbations drive disease progression     and worsening quality of life and therefore prevention of exacerbations has been a major goal     of treatment.      Patients with COPD are frequently prescribed inhaled corticosteroids (ICS) which have been     shown to reduce exacerbations in combination with long acting beta2-adrenoceptor agonists     (LABA). In recent years, all ICS preparations have been associated with a significant     increased risk of pneumonia in either randomised trials or observational studies leading to     warnings from national regulatory authorities and leading experts. This has led to a     re-evaluation of the role of ICS in COPD treatments. It is likely that the risk of pneumonia     is not equal across all ICS doses and molecules.      There is a compelling rationale for ICS having a strong effect on the upper airway     microbiome, and that this may be one mechanism of increased pneumonia risk with these drugs.     The existing literature regarding ICS and pneumonia risk are lacking; 1) there are no head to     head trials comparing different ICS preparations and 2) the comparator in these studies to     date have been long acting beta2-adrenoceptor agonists alone, whereas the most appropriate     comparator in current management would be combined LABA and long-acting muscarinic antagonist     (LAMA).      The MUSIC TRIAL is a multi-centre randomised open label controlled parallel group study with     four treatment arms and a total of 120 participants. Severe COPD patients currently treated     with inhaled corticosteroid therapy will be randomised to treatment with one of three     preparations of ICS in combination with LABA or the control arm of dual bronchodilator     therapy following a four week washout period. Participants will return monthly to determine     if there are changes in the microbiome in their upper airway.      This study will establish one potential mechanism for the increased susceptibility to     pneumonia in ICS users and assess intraclass differences in ICS molecules and the effect of     ICS dose on the microbiome. Demonstrating that different COPD treatments can have different     effects on the lung microbiome is an important step in understanding clinical differences in     the safety and effectiveness of different treatments for severe COPD.   "
23944|NCT02972463|"     The purpose of this study is to determine the optimal dose of IgY as assessed by changes in     the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut     microbiome as assessed by 16s RNA sequencing of fecal samples.   "
23945|NCT02972450|"     EVHA T01 is a Phase IIb randomised therapeutic HIV vaccine trial in individuals who started     antiretrovirals during primary or chronic infection. HIV+ participants will be randomised to     receive active vaccine or placebo.   "
23947|NCT02972424|"     In the proposed trial the investigators will recruit women and men >65 years of age with     acute osteoporosis-related pelvic fractures and address 3 specific aims over 3 months of     treatment in a placebo controlled double blind study to determine if standard care and     teriparatide 20 mcg/day versus placebo for pelvic fractures:        1. Results in earlier evidence of cortical bridging on routine radiographs followed by          confirmatory Focus CT, a novel method to reduce radiation exposure from CT scans          (primary outcome).        2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a          reduction in the use of narcotics (secondary outcome).        3. Leads more rapidly to improved functional outcome using a short physical performance          battery to assess lower extremity function (secondary outcome).   "
23948|NCT02972411|"     This study evaluates the safety and efficacy of the voluntary ventilatory response as     prophylaxis for acute mountain sickness, measured by the Lake Louise Self-Report Score,     comparing to a group using acetazolamide.   "
23949|NCT02972398|"     The aim of this study is to evaluate the efficacy of N-acetylcysteine (NAC) add-on to     antidepressant medication in treating patients who do not relieve during standard     antidepressant treatment for 6 weeks at least. Meanwhile, secondary outcomes will include     changes in some biomarkers and on specifically local brain activity (functional Magnetic     Resonance Imaging, fMRI) and white matter integrity (Diffusion Tensor Imaging, DTI). The     hypothesis of this study is that NAC has positive effects on refractory major depressive     disorder patients with increased inflammatory activity.   "
23966|NCT02972177|"     The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy     guided transbronchial ablation for the treatment of early-stage inoperable peripheral lung     cancer.   "
23975|NCT02972060|"     This is an open label non-comparative controlled randomized phase II study. The experimental     arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is     included as an internal control.      The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen     (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in     the range of those achieved with 24 weeks of ADT.      In total, this 1:1 randomized study will therefore require randomization of at least 250     patients, 125 to each arm.   "
23950|NCT02972385|"     Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important     to take the right dose of warfarin because too much can increase the risk of bleeding and too     little can increase the risk of blood clots. This is why patients are closely monitored     especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have to     consider different factors such as patient's age, body size, diet, and other medications that     can interact with warfarin.      Certain genes have also been found to affect warfarin dose. Individuals have variations in     these genes, which can help explain why some patients need higher dose and others require     less. These factors have been used to better predict a patient's warfarin dose requirement.     However, these predictions were created based on Caucasian populations and they may not be     accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims to     identify new genetic variation that affects warfarin dosing in Hispanic and Latino     populations and try to better predict a Hispanic or Latino patient's warfarin dose     requirement.   "
23951|NCT02972372|"     The aim of this study is to compare outcomes in Chinese patients with locally advanced     resectable esophageal squamous cell cancer who have received either surgery or definitive     chemoradiation (CRT) by the randomized, open-label, multicenter trial.   "
23952|NCT02972359|"     The aim of this trial is to investigate the safety of intravenous neridronic acid in patients     with complex regional pain syndrome (CRPS).      The trial is divided into 3 periods: a 60-day enrollment period, a treatment period     consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks     (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).   "
23953|NCT02972346|"     Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic     syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main     relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum     cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney     cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid     resistant or steroid dependent NS is enrolling in this multicenter, prospective case series     of prescription based treatment with ACTH for NS.   "
23954|NCT02972333|"     The study aims to investigate the efficacy and safety of AZD9291 in brain metastases from     patients with EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI.   "
23955|NCT02972320|"     This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage     SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first     line treatment.   "
23956|NCT02972307|"     There has been only minimal research on wheelchair skills by the caregivers of manual or     powered wheelchair. There are no published data on the extent to which caregivers can enhance     the mobility of powered wheelchair users. The primary objective of this study is to test the     hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance     of the powered wheelchair users to whom they provide assistance. Our secondary objective is     to add to the literature on the measurement properties of the wheelchair skills test     (questionnaire and capability version) for powered wheelchair users and their caregivers.   "
23957|NCT02972294|"     Fractures of the upper end of the femur, called commonly Hip fractures are very common,     with an incidence of approximately 1.6 million cases per year worldwide. This high incidence     is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is     very frequent on admission for hip fracture, concerning up to 45% of the patients, with a     mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood     losses, secondary to the fracture itself and surgery are responsible for a high rate of blood     transfusion (approximately 40-50% of the patients). However, both anemia and blood     transfusion are associated with poor outcome, including increased mortality, length of stay,     infection rate etc. In addition, blood is a scarce and expensive resource and its use should     be limited as much as possible. There is therefore a need to treat this anemia and/or to     prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed.     Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous     iron was able to reduce blood transfusion (i.e. the number of patients transfused and the     number of units per patient). Another way to reduce blood transfusion would be to reduce     perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in     trauma patients and in elective surgery patients.The interest for perioperative blood     management has recently increased thanks to better recognition of the adverse effects of     blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a     renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose     a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of     iron and tranexamic acid to reduce blood transfusion in hip fracture patients.   "
24001|NCT02971501|"     This randomized phase II trial studies how well osimertinib with or without bevacizumab works     in treating patients with EGFR positive non-small cell lung cancer that has spread to the     brain. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability     of tumor cells to grow and spread. Giving osimertinib with or without bevacizumab may work     better in treating patients with non-small cell lung cancer.   "
23958|NCT02972281|"     Antibody deficiencies and complement deficiencies are the most frequent Primary     immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility     to recurrent and/or severe bacterial infections - especially upper and lower respiratory     tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in     adults. The current European and US guidelines advocate screening adults for PIDs if they     present recurrent benign especially upper and lower respiratory tract infections, or if they     have experienced at least two severe bacterial infections and/or have a recurrent need for     intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in     adult patients who present such recurrent infections and/or after the first severe bacterial     infection, especially when the patients do not present with known, etiologically relevant     comorbidities.   "
23959|NCT02972268|"     Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination     Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic     Hyperplasia   "
23960|NCT02972255|"     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study     that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the     combination of RO7079901 with meropenem in healthy volunteers. The study will consist of     three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy volunteers     will be randomized to receive active study drug or placebo in a 3:1 ratio.   "
29530|NCT02899130|"     This trial will study the effect of a polyherbal capsule in lowering the viral load of     patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B     surface antigen elimination in 12 months   "
23967|NCT02972164|"     Levels of overweight and obesity have reached alarming proportions in Qatar and other Gulf     nations. In Qatar, the need to establish national strategies for the prevention and treatment     of obesity has been recognized in the new Qatar National Health Strategy 2011-2016, which     stresses the need for prevention. In fact, the Qatar National Nutrition and Physical Activity     Action Plan 2011-2016 calls for nutrition and physical activity interventions for the     prevention of obesity and related chronic diseases such as diabetes. The treatment and     prevention of childhood obesity is largely through lifestyle changes- encouraging health     eating and physical activity and discouraging sedentary behavior. However, changing such     behaviors is complex and requires a combination of integrated approaches to tackle such a     multifaceted problem. Herein, the investigators set out to implement and evaluate a novel     weight management program for Qatari school children at the vulnerable age of 9-12 years. The     project incorporates a cognitive-behavioral approach that involves developing social and     emotional competences, promotion healthy dietary habits, development of physical literacy,     and use of activity monitoring devices to promote increased activity while enlisting family     involvement in an attempt to maintain weight loss in the long term. This project seeks to     also take things further by integrating a range of interventions that use cutting edge     insights from the behavioral sciences through the use of MINDSPACE approach (MINDSPACE:     Messenger, Incentive, Norms, Default, Salience, Priming, Affect, Commitment, Ego) in     conjunction with technology tools for monitoring activity and providing ongoing support     through the use of social media. The intervention involves a multi-cohort intervention     involving 500 Qatari children over 5 years to be conducted in three phases (1) intensive     weight loss camps, (2) after-school clubs as supplement/consolidation, and (3) maintenance     through web and social/family support.   "
23968|NCT02972151|"     The trial attempts to optimize, standardize and simplify the characteristic diagnosis and     treatment program of the dominant diseases in our hospital-the sequelae of pelvic     inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in     primary hospital.   "
23978|NCT02972021|"     Chronic respiratory insufficiency in patients with advanced disease to the late treatment     depends mainly on mechanical ventilation and other high intensity respiratory support     therapy. Strengthen the stability of chronic respiratory insufficiency intervention can     reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal     cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of     respiratory support therapy. There is little research on the role of HFNC in oxygen therapy     for chronic respiratory insufficiency.      Our previous studies have found the potential value of HFNC in chronic respiratory     insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of     chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals     in an effort to confirm that HFNC can improve the prognosis of patients with chronic     respiratory insufficiency compared with nasal oxygen therapy.   "
23969|NCT02972138|"     Sickle cell disease (SCD) is a worldwide distributed hereditary red cell disorder, which     affects approximately 75,000 individuals in the United States and almost 20,000- 25,000     subjects in Europe, this latter mainly related to the immigration fluxes from endemic areas     such as Sub-Saharian Africa to European countries. Studies of global burden disease have     pointed out the invalidating impact of SCD on patient quality of life. This requires the     development of new therapeutic options to treat sickle cell related acute and chronic     complications. SCD is caused by a point mutation in the β-globin gene resulting in the     synthesis of pathological hemoglobin S (HbS). HbS displays peculiar biochemical     characteristics, polymerizing when deoxygenated with associated reduction in cell ion and     water content (cell dehydration), increased red cell density and further acceleration of HbS     polymerization. Pathophysiological studies have shown that dense, dehydrated red cells play a     central role in acute and chronic clinical manifestations of SCD, in which intravascular     sickling in capillaries and small vessels leads to vaso-occlusion and impaired blood flow     with ischemic/reperfusion injury. In microcirculation, vaso-occlusive events (VOC) result     from a complex and still partially known scenario, involving the interactions between     different cell types, including dense red cells, reticulocytes, abnormally activated     endothelial cells, leukocytes, platelets and plasma factors. Target organs, such as bone or     lung, are involved in both acute and chronic clinical manifestations of SCD, related to their     peculiar anatomic organization mainly characterized by sluggish circulation and relative     local hypoxia. VOCs combined with marrow hyperplasia and inflammation has been suggested to     contribute to the development of sickle bone disease (SBD). Recently, it has been proposed a     possible role of vitamin D deficiency in SBD, which appears to be subordinated to the primary     defect in bone homeostasis. In a humanized mouse model for SCD, we recently reported that SBD     is due to imbalance between osteoblast/osteoclast activity induced by recurrent VOCs. In     addition, we show that zoledronic acid prevents bone impairment related to SCD, reducing     osteoclast activity and improving osteoblast performance.   "
23970|NCT02972125|"     This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet     and Dry Syrup in Healthy Male Japanese Subjects   "
23971|NCT02972112|"     Women in their 3rd trimester, represent a unique segment of the tokophobic population. In     these cases help is needed within a very short and limited period of time. To date, no     specific treatment targets this population in order to ameliorate the anxiety and to provide     these women and their newborns with better obstetric and psychiatric outcomes. The present     study investigates an accessible individual two session intervention conducted by midwives     skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable     stronger emotional regulation and increase of their capacity to accept unexpected changes     during labor and feelings of control. The investigators expect this psychological adjustment     to lead to a better course of delivery, less interventions including caesarian sections, and     subjective birth experience.   "
23972|NCT02972099|"     The objective of the study is to assess the short-term and long-term effects of     transcutaneous pulsed radio frequency treatment on the physiological status, subjective     well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is     a method that is widely used for control of pain. There are no known complications. In this     study a Radiofrequency generator will be used that has a separate outlet for transcutaneous     use. Patients will be recruited within the clinic population of patients.   "
23973|NCT02972086|"     The purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC)     Model. The IPFAC is intended to increase access to evidence-based behavioral parent training     (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD)     who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of     Developmental and Behavioral Pediatrics.   "
23974|NCT02972073|"     The purposes of this study include 1) determine clinical utility of clinical observation of     aberrant movement patterns during functional trunk and pelvic movements in asymptomatic     individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular     control in asymptomatic individuals and patients with non-specific low back pain, and 3)     determine the appropriate physical therapy intervention that addresses trunk neuromuscular     control deficits in patients with non-specific low back pain.   "
23976|NCT02972047|"     This study aims to understand why patients have predominantly upright gastroesophageal reflux     disease by comparing such patients to healthy persons AND whether a behavioral intervention     (diaphragmatic breathing) will impact this disease   "
23977|NCT02972034|"     This study will evaluate the safety, tolerability and preliminary efficacy of MK-8353 when     administered in combination with pembrolizumab (MK-3475). There are two parts in this study:     Part 1 will be dose escalation and confirmation, and Part 2 will be a cohort expansion. In     Part 1, the recommended phase II dose (RP2D) of MK-8353 in combination with a fixed dose of     pembrolizumab in participants with advanced malignancies will be identified and confirmed.     Participants will be initially enrolled to receive MK-8353 at 350 mg twice a day (BID) in     combination with pembrolizumab at a fixed dose of 200 mg on Day 1 of each 3-week cycle (Q3W)     for up to 24 months of treatment. In Part 2, participants with advanced colorectal cancer     (CRC) who received at least one and up to five prior lines of therapy will be enrolled at the     RP2D in the expansion cohort to further evaluate safety and efficacy.      The protocol was amended to add lower doses of MK-8353 in combination with pembrolizumab. In     addition, 2 optional arms: one in which MK-8353 will be administered 1 week on/1 week off at     a starting dose of 150 mg BID in combination with pembrolizumab and one in which MK-8353 will     be administered continuously at a starting dose of 200 mg once a day (QD) in combination with     pembrolizumab.   "
24002|NCT02971488|"     Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction     strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care     setting with services to reduce the risk of reinfection and for management of the common     social and psychiatric comorbidities in this population. More frequent diagnosis, new methods     that prevent loss of tracking, and access to antiviral treatment are all strategies that must     be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.   "
24003|NCT02971475|"     The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for     treatment of pain in chronic pancreatitis.   "
24228|NCT02968537|"     The study aims to investigate the effects of a short computerized training as a therapeutic     add-on to standard therapy in patients with alcohol-use disorder.   "
23979|NCT02972008|"     Over the past ten years, the number of endovascular procedures has increased by 5% per year     in Europe with the development of interventional cardiology, such as percutaneous coronary     angioplasty, aortic valve replacements (TAVR), and vascular endoprosthesis.      The neurological lesions detected on cerebral MRI caused by these endovascular procedures are     frequent with an incidence of about 30-70%. These events, although subclinical, have an     impact on morbidity and mortality and especially on long-term cognitive decline.      TAVR is the reference treatment for symptomatic elderly patients with stenosis of the aortic     valve, considered by a multidisciplinary Heart Team as at high surgical risk due to     comorbidities, age and high perioperative risk scores ( Euroscore 2 and STS scores). Despite     the net clinical benefit, an increase of silent neurological events was detected on     post-procedural cerebral MRI with an incidence of approximately 70%.      The epigenetic involvement in the occurrence of ischemic cerebral lesions is still largely     unknown. Epigenetic mechanisms, such as DNA methylation, can be associated with aging     processes and modulate the risk of developing cerebrovascular pathologies. They are likely to     provide new biomarkers that predict the risk of brain damage.      Hypomethylation of leukocyte DNA is directly related to atherosclerosis in humans. This     hypomethylation of DNA would represent an easily measurable marker reflecting the presence     and progression of atherosclerosis. Because atherosclerotic lesions often precede the     clinical manifestation of ischemic cardiovascular disease, such as ischemic heart disease and     stroke, DNA hypomethylation could be used to identify individuals at risk for cerebrovascular     events.      The investigator hypothesize that hypomethylation of leukocyte DNA can predict the risk of     developing new ischemic brain lesions especially after a TAVI procedure.   "
23980|NCT02971995|"     Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology,     the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other     hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and     has an affinity for prostate cells. Its concentration is directly proportional to cell     proliferation. The analogue of choline has the advantage of having a rapid and stable     accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after     injection).      The goal of this study is to assess the feasibility and the accuracy for targeting image     guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT     compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal     ultrasound (TRUS) .   "
23981|NCT02971982|"     Patients will receive RCD or PCD combination as induction treatment followed by rituximab or     velcade maintenance therapy, as the investigators try to compare the, very good partial     remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR +     partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the     research.   "
23982|NCT02971969|"     A long-term follow-up study to evaluate the safety, tolerability, and efficacy of DTX101 in     adult males with moderate/severe to severe hemophilia B.   "
23983|NCT02971956|"     This research study is studying a targeted therapy as a possible treatment for advanced     esophageal cancer.      The study intervention involved in this study is:      -Pembrolizumab   "
23984|NCT02971943|"     To verify whether X-ray combined with MRI is able to carry out correct fracture     classification and postoperative evaluation in patients with ankle fractures.   "
23985|NCT02971930|"     This study is to generate qualitative data to evaluate the impact of frequency of FVIII     infusions on patients' satisfaction with treatment and their quality of life.   "
23986|NCT02971917|"     To validate the following theory: With TRUVIEW ART™ applied a detector's quantitative     performance index, MTF(Modulation Transfer Function), is increased 20% or more. This is to     examine the effect of the increased MTF index, whether it influences or not the interpreter's     preference   "
23987|NCT02971904|"     An observational and prospective study involving about 30 healthy lactating mothers whose     preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and     who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until     15th day of hospitalization or until discharge.      Considering the lack of evidence related to breast milk nutritional composition from     Brazilian lactating mothers of preterm infants; and also the utilization of human milk     analyzer as a tool to optimize nutritional therapy and reach proper growth and development of     preterm babies, this study aim to evaluate the nutritional composition of human milk from     lactating mothers of preterm infant during the hospitalization, the infant grow and also the     applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.   "
23988|NCT02971891|"     To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide     Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital     cutaneous common warts (verruca vulgaris).   "
23989|NCT02971878|"     Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and     a-lipoic acid) on embryo development and subsequently the clinical outcome. Including clinics     using low oxygen and ambient air during embryo culture. Analysed with time-lapse system.      Study media: G-TL with antioxidants. Control media: Same media without antioxidants. Type of     study: Study comparing blastocyst development on the same cohort of oocytes using two     different media, G-TL versus G-TL supplemented with antioxidants. Statistics based on an     absolute increase in Good Quality Blastocysts on day 5 of 7%.      Design: Multicentre prospective randomized sibling trial. Single blastocyst transfer.     Superiority study Primary Endpoint: Good Quality Blastocysts on day 5 per allocated normally     fertilized oocyte.      Patients: Comparative embryo sibling study with 128 patients included.   "
23990|NCT02971865|"     Effects of manual medicine or cognitive behavioral therapy with chronic uncontrolled diabetes     within a shared primary care visit. An evaluation of the effectiveness of manual therapy vs     cognitive behavioral therapy (CBT) vs traditional primary care visit care is in need.   "
24000|NCT02971514|"     This randomized controlled crossover trial conducted on 25 dental students. in the     preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and     toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were     instructed the proper techniques of brushing and flossing.The study was performed in two     treatment sessions and a 48 hour washout period. They passed through the sessions in a     randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all     oral hygiene for 24 hour. At the first session , they flossed first followed by brushing     (floss-brush group) and at the other session they used dental floss after brushing     (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque     reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was     collected for measuring fluoride. Differences between the two groups were analyzed with mixed     model test.   "
32169|NCT02864693|"     The purpose of this research is to evaluate benefits of a microprocessor controlled     prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon     fiber prosthetic ankle-foot device.   "
23991|NCT02971631|"     Patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer     are known to have a significantly reduced quality of life. To date, there is very little     information on the physiological causes of this. The investigators suspect that     overproduction of a hormone (chemical) called glucagon like peptide-1 (GLP-1) released by the     lining of the gut may play a role in the reduced appetite, weight loss and low blood sugar     symptoms seen in this group. To investigate this, the investigators will study the response     of 16 patients who have previously had a gastrectomy to a glucose drink, and a meal, while     receiving an infusion of a specific blocker of GLP-1 or placebo. The investigators will     examine the levels of sugar and associated hormones in the blood, food consumption and food     reward behaviour using standard tools.      Participants will be invited to attend the Clinical Research Facility at Addenbrooke's     Hospital for a screening visit, and two whole day study visits. The study has been designed     to assess the role of overproduction of GLP-1 by completely blocking its actions, rather than     assess the use of the blocking compound as a medication, and is therefore regarded as a     physiological study, not a clinical trial.      The goal of this study is to demonstrate the magnitude of effect of GLP-1 on blood sugar and     appetite derangement in patients who have had a gastrectomy. This will guide future work on     the development of novel treatment paradigms for the post-gastrectomy patient group.   "
23992|NCT02971618|"     The study will retrospectively collect clinical variables and socio-demographic data from     medical records of patients with T2DM initiating treatment with dapagliflozin after the     previous failure/inefficiency of other treatment options (defined as non-achievement of     target Hb1Ac) and according to the officially approved indication as per instruction for the     use of medicinal product.      It is expected that the best available data regarding clinical variables and patient     socio-demographic profiled will be collected from the patient medical records at up to 40     major Russian outpatient clinics/centers specialized in the treatment and management of T2DM     patients.      There are 2 time points:        -  Baseline data: baseline data are defined as data available within 3 months prior to the          first dose of dapagliflozin. In case of presence of multiple data values within baseline          period the most recent pre-dose value will be selected        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary          analysis will be focused on data available at 6 plus/minus 3 months after the initiation          of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at          routine visit within 3-month time frame after the last dose   "
23993|NCT02971605|"     The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin)     leads to changes in emotion processing and neural circuitry that may predict repeated     self-administration of this drug and underlie an atypical mechanism of abuse liability, which     may vitally contribute to the understanding of the potential for abuse and the underlying     mechanisms supporting abuse of classic hallucinogens.   "
23994|NCT02971592|"     This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1     listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity     (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to     reduce muscular aches and pains particularly of the lower back.      assessing the reduction of lower back pain. Half of participants will receive the MDcure     device, while the other half will receive a mock device.   "
23995|NCT02971579|"     This is a prospective observational longitudinal study      Aim of the study is to collect information:        -  on the organization models of the Endoscopic Units performing ERCP in Italy        -  on the previous and/or ongoing training of the endoscopists performing ERCP        -  on the clinical characteristics of patients undergoing ERCP in Italy as well as on the          outcome   "
24022|NCT02971228|"     The purpose of this study is to determine whether the Bionic Pancreas with ZP4207     (dasiglucagon*) is feasible to improve glycemic control in adults with type 1 diabetes     mellitus.      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207   "
24023|NCT02971215|"     The purpose of this study is to assess the effectiveness of high intensity laser therapy in     the treatment of subacromial impingement syndrome.   "
23996|NCT02971566|"     Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical     arteries places preterm infants at significant risk for developing gastrointestinal     complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous     intestinal perforation. Due to the fear of the aforementioned conditions, the establishment     of adequate enteral feeds is frequently hampered in this population. Previous postnatal     Doppler studies have shown that AREDF preterm infants who later developed feeding intolerance     have a decreased blood flow velocity in the superior mesenteric artery in response to the     first enteral feed; to date, however, it is not known whether this hemodynamic impairment     persists over time, or if it is associated with reduced splanchnic oxygenation and perfusion,     monitored by Near-infrared spectroscopy (NIRS).      This observational prospective study aims:        -  to assess the patterns of abdominal oxygenation and perfusion in response to enteral          feeds in AREDF preterm infants at different phases of enteral feeding establishment;        -  to evaluate a possible correlation with the development of gastrointestinal          complications.   "
23997|NCT02971553|"     Each year, almost 3 million newborn babies die within their first month of life, often as a     consequence of labour complications. Approximately 5% of newborns will not start breathing at     birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has     not been determined. Animal studies suggest that assisted ventilation with positive end     expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid     recovery. However, no large human clinical studies have investigated the clinical responses     to assisted ventilation with PEEP in asphyxiated newborns.   "
23998|NCT02971540|"     The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy     and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain     perception postoperatively.      Patients received either preemptive local tissue infiltration at surgical site using either     0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous     infusion using metamizole and tramadol.   "
23999|NCT02971527|"     The purpose of this study is to examine whether ultrasound bone strength device (Model     Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of     human subjects, compared with a listed, similar device (Model Number: SONOST3000).   "
24004|NCT02971462|"     The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would     reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of     atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.   "
24006|NCT02971436|"     This study will investigate the efficacy of the FPH modified positive airway pressure (PAP)     device with or without SensAwake; and with different pressure support in OSA participants; in     both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure     delivery will also be evaluated. The FPH device will be compared to a market released     product.   "
24007|NCT02971423|"     This research project is being conducted to look at the safety, tolerability, and     pharmacokinetics (PK; how the human body processes a substance) of ETX2514 when given to     healthy volunteers intravenously as a single dose, and when given as multiple intravenous     doses for up to 8 consecutive days.      As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii (a     type of bacteria) infections, this project will also look at whether ETX2514 will interact     with the current treatments for these infections when they are administered at the same time.   "
24008|NCT02971410|"     This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy     resistance in patients with multiple myeloma that has come back or does not respond to     treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
24009|NCT02971397|"     This pilot clinical trial studies the side effects of cytarabine and daunorubicin     hydrochloride and to see how well they work in treating patients with newly diagnosed acute     myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading, and may be     safer for the heart.   "
24010|NCT02971384|"     Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg)     in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract     infections.   "
24011|NCT02971371|"     Many studies have demonstrated the usefulness of repetitive task practice by using robotic     devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has     proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized     clinical trial aimed at evaluating the correlation between the modifications of brain     oscillations during a VR neurorehabilitative training of gait and the motor function recovery     in patients with chronic stroke.      Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase     were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR)     whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical,     kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG)     were measured before and after the robotic intervention.      The robotic-based rehabilitation combined with VR could be associated with improvements in     several measurements of lower limb function, gait, and balance in patient with chronic     hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor     performance and to develop non-invasive brain-computer interfaces controlling robotic     devices.   "
24024|NCT02971202|"     The purpose of this study is to determine the key factors influencing insulin sensitivity in     type 1 diabetes (T1DM) and maturity onset diabetes of the young, type 2 (MODY2).      Our study tests the hypothesis that decreased insulin sensitivity is primarily driven by     chronically elevated insulin levels in the blood rather than chronic elevations in blood     sugar.   "
24025|NCT02971189|"     A prospective, single-arm, non-randomised study to evaluate the Librata device performance     and acute safety in performing global endometrial ablation in pre-menopausal women with heavy     menstrual bleeding.   "
24026|NCT02971176|"     The purpose of this study is to compare the diagnostic accuracy and complication rate between     low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.   "
24012|NCT02971358|"     Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading     cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men     have died from prostate cancer. Although radiation and surgery are quite effective for     localized disease, there is no effective cure for men who present with metastatic prostate     cancer as the 5-year relative survival rate is only 28%.      Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the     standard first-line therapy in men with metastatic disease but castration-recurrent prostate     cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops,     secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.      Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must     be explored to improve the clinical outcome. In this regard, recently emerging data suggest     that local tumor control may enhance the effectiveness of subsequent systemic therapies.     Therefore, in this proposal, the investigators have designed a Phase I/II study in which they     will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men     with newly diagnosed mPCa.   "
24013|NCT02971345|"     It is a prospective and multi-center clinical research in China to compare the efficacy,     safety and related impact factors between TACE alone and endovascular brachytherapy combined     with stent placement and TACE for HCC with main portal vein tumor thrombus.   "
24014|NCT02971332|"     Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study     the investigators want to evaluate the long term results of Stapled Transanal Rectal     Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A     re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was     conducted.   "
24016|NCT02971306|"     Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are     died within first 6 months after the detection of the clinical syndrome. Therefore, it is     very essential for proper diagnosis and early treatment. In response to acute or chronic     liver damage, bone marrow derived stem cells can spontaneously populate liver and     differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte     may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is     highly dependent on varieties of liver injury and therapeutic conditions6. The studies has     suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing     with hematopoietic cells, thereby enhancing the liver histology and survival rate.      G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent     studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with     alcoholic hepatitis. In two of this studies there was a survival benefit with the use of     G-CSF.      Alcoholism leads to decrease in endogenous antioxidant potential. Alcoholic liver disease     (ALD) patients show low endogenous antioxidants. Chronic ethanol consumption cause selective     deficiency in the availability of reduced glutathione (GSH) in mitochondria has been     reported. This is due to impaired functioning of GSH transporter from cytosol to     mitochondrial matrix. The effect on glutathione replenishing potential by N-acetyl cysteine     (NAC) can be used to reduce oxidative stress, which also has excellent safety profile.     Therefore, NAC can be used for severe alcoholic hepatitis treatment due to its therapeutic     potential factor. NAC also inhibit apoptosis and pro-inflammatory cytokine production. In a     study high doses of intravenous N-acetyl cysteine therapy for 14 days conferred neither     survival benefits nor early biological improvement in severe alcoholic hepatitis patients     with adequate nutritional support.However, these results must be viewed with caution, since     the study suffered from a lack of power. In a recent study, NAC and corticosteroids     combination therapy benefits among patients with severe acute alcoholic hepatitis in 1 month     survival, although the final outcome at 6 month survival was not improved. There are no     studies on the use of combination therapy of NAC plus G-CSF in patient with severe alcoholic     hepatitis.      Therefore we plan to study the safety and efficacy of combination therapy of G-CSF and NAC in     the patients with alcoholic hepatitis.   "
24017|NCT02971293|"     This is a study to evaluate the effects of AZD8871 in patients with COPD. Adult male or     female patients with moderate to severe COPD, who agree to be in this study, will receive 3     treatments, i.e. 2 different doses of AZD8871 and placebo (dummy medication containing no     drug) at once a day for 2 weeks, in a random order. To make the comparison between AZD8871     and placebo as fair as possible, this study is double blinded. This means that neither     patient nor the study doctor will know in which order the 3 treatments will be given. This     study will include patients who are between 40 and 80 years of age. In total there will be 42     patients participating in this study at two study centers in the United Kingdom and Germany.     The study will have a total of 12 visits for each patient spanning for a period of 4 to 6     months. The study is anticipated to run for approximately 8 months and should not exceed 10     months.   "
24018|NCT02971280|"     Exposure to heavy metals may interfere with basic cellular functions, including DNA     synthesis.      The aim of the study is to correlate heavy metals concentration in body fluids of     reproductive importance and IVF outcome.   "
24019|NCT02971267|"     Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated     inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized     protocols will be used for the assessment of medical history and examinations, laboratory     biomarkers, and the collection of various biomaterials for biobanking purposes.   "
24020|NCT02971254|"     Recovery of the cognitive functions and recovery features after general anaesthesia in Down     syndrome patients. A comparison of Sevoflurane and Desflurane.   "
24021|NCT02971241|"     The primary purpose of the study is to understand the potential of mobile computing     technology to improve chronic disease self-management, quality of life, and health outcomes     of older adults to prevent or alleviate future disabilities. Thus, the study will design,     develop, and test an intervention to motivate and train seniors to use the technology, and     conduct a trial to evaluate its effect. This innovative intervention will deploy young     generation (age 18 to 30) volunteers to provide mobile technology training, access, and     support to older adults (aged 55 and above) with type 2 diabetes in Taiwan. Hence, a     secondary purpose of the study is to understand the effects of the volunteering experience on     the values, characters, and health awareness in the young generation. This program, called     the Intergenerational Mobile Technology Opportunities Program (IMTOP), will help older adults     with type 2 diabetes acquire skills to use the Internet, World Wide Web (WWW), applications     (or apps), and basic computing via mobile tablet devices. These skills will give     participants access to resources and tools to improve health and mental health, reduce social     isolation, and increase social engagement, as well as meet their individual life goals. The     course will use young volunteers to deliver the tablet training. The training course will be     offered as small-group sessions over an 8-week period (for up to 16 hours of training) at a     hospital site, plus young volunteers' technical support and problem solving for up to 4 weeks     after the training sessions are completed. Using college students to serve as volunteer     trainers for teaching mobile technology, the research also aims to understand not only how     the intergenerational interactions help the older adults learn the technology and improve     health, but also how they make impacts on the young adults' skills and experiences that will     help them in their future careers and in the development of their characters. This research     study will recruit three hundred fifty (350) patients from the collaborating hospitals,     including two hundred fifty (250) patients from Taipei Tzu Chi Hospital and one hundred (100)     patients from Hualien Tzu Chi Hospital. An estimate of 140 students in colleges and     universities in Taiwan (100 volunteers in Taipei hospital and 40 volunteers in Hualien     hospital) between the age of 18 and 30 will be recruited to serve as volunteer instructors to     teach older adults to use tablets and to provide technical support services. Moreover,     another group of 140 young adults, also age 18 to 30, will be recruited from universities to     serve as the comparison group to the volunteers in intervention group. The course objectives     are to guide older patients with Type 2 diabetes to use technology to obtain diabetes-related     medical information, learn to record and control their physiological data via technology,     promote intergenerational communication, enhance the convenience in life, and improve social     life and mental health through technology tools such as the Internet, social media, online     health education resources, instructional videos and so on. It is hoped to further slow down     degradation, promote health and prolong life.   "
24027|NCT02971163|"     Syncope, or transient loss of consciousness/fainting, is a common emergency department (ED)     complaint responsible for over 1 million ED visits yearly. Potential causes include benign     conditions such as dehydration or vaso-vagal syncope. Rarely, syncope is the result of     serious cardiac conditions. In older patients without a clear cause of syncope hospital     admission is frequently initiated at very low risk thresholds, though there is little     evidence that these admissions improve patient outcomes. These decisions are often made     without significant patient input or discussion of reasonable alternatives. In this     situation, a patient's values, preferences, and particular circumstances should be taken into     account. This mutualistic approach to clinical management is referred to as Shared     Decision-Making. Shared Decision-Making (SDM) is a joint process of choice selection between     providers and patients in clinical scenarios where multiple reasonable management options     exist. To improve syncope emergency care, the researchers can leverage recent advances in     risk stratification to engage patients in SDM and deliver superior, patient-centered care.      This study will provide the groundwork for a larger, randomized controlled trial evaluating     the effects of the decision aid for management of low-risk syncope.   "
24028|NCT02971150|"     The purpose of this pilot study is to obtain information about older Veterans' preferences     for treatment of depression and insomnia and to pilot test the feasibility and clinical     effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with     Treatment Resistant Depression (TRD) and insomnia.   "
24029|NCT02971137|"     This purpose of this study is to test the telephone delivery of a cognitive behavioral     intervention (CBI), for smoking cessation among Veteran smokers with chronic pain.   "
24030|NCT02971124|"     To assess cognitive performance by means of the game of Solitaire. In this study, the     investigators want to define relevant game metrics, when playing Solitaire, that may be     indicative of cognitive performance.   "
24032|NCT02971098|"     The over-65 population is not only increasing at an alarming rate, but because six out of 10     will be managing more than one chronic condition by 2030, they will make up a much greater     proportion of hospitalizations than ever before. Hospitalizations for disease, injury, and/or     surgery in this group are likely to impair physical mobility and, therefore, the older adults     capacity to be physically active both during hospitalization and beyond. The resulting     sedentary lifestyle is likely to be accepted as the new normal, ultimately increasing the     risk of skeletal muscle and metabolic dysfunction (e.g. impaired glucose disposal, insulin     resistance). These devastating outcomes are neither inevitable nor necessary if prevented     with an appropriate mechanism-based intervention.      A novel mechanism that may contribute to physical inactivity-induced insulin resistance is     accumulation of inflammation and ceramide within skeletal muscle. Of interest, increased     skeletal muscle inflammation and ceramide has been tied to various metabolic disturbances     such as diabetes and insulin resistance. However, it is currently unknown if skeletal muscle     inflammation and ceramide are a key mechanism associated with insulin resistance due to     physical inactivity in older adults.   "
24033|NCT02971085|"     In this study, the investigators aim to establish the prostate cancer active surveillance     prospective cohort in our institution, and finally investigate the 5 year rates of     reclassification during active surveillance as the primary endpoint of the current study.   "
24034|NCT02971072|"     The purpose of this study is to examine deficits in activation and motor patterns, as well as     central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1)     determine the effect of acute pain relief on rotator cuff muscle activation in patients with     rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle     activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle     activation between patients with rotator cuff tendinopathy and healthy controls.   "
24035|NCT02971059|"     Currently there are insufficient published studies on amino acid requirements in the elderly.     Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been     observed in in the blood of older adults. It is due the increased uptake by the liver and     intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle     protein synthesis. Requirement for elderly individuals have been set based on studies     conducted in younger adults hence may be inaccurate. The goal of this study is to directly     measure the phenylalanine requirement of male and female elderly subjects over 65 years using     the direct amino acid oxidation (DAAO) technique.   "
24036|NCT02971046|"     The fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from     damage, in the erythrocytes of healthy school-aged children in response to graded intakes of     protein to determine if increasing the protein intake above the current recommended DRI     produces increases in the GSH synthesis rates in erythrocytes of healthy school-aged     children. Participants will consume specially formulated diets with varying protein levels.   "
24037|NCT02971033|"     To address the need for more affordable hepatitis C virus (HCV) antivirals with high barriers     to viral resistance and strategies to shorten the current treatment duration, the goal is to     develop affordable therapeutic regimens to prevent HCV entry/spread and test the efficacy of     those inhibitors for treating HCV infection. The investigators recently discovered that a     major cholesterol uptake receptor is required for HCV entry into hepatocytes and that there     is already an FDA-approved drug that inhibits cholesterol uptake by this receptor.     Importantly the same drug also potently blocks HCV entry in human liver cells both in cell     culture and in a small animal model. Further, looking back at people who were previously     treated for HCV infection, the investigators found treatment response to be better (i.e.     larger viral log reduction) in patients who happened to be taking ezetimibe (EZE). Hence, the     objective of this study is to assess whether the FDA-approved drug (ezetimibe) is useful for     the treatment of chronic HCV. The investigators predict that when administered as monotherapy     ezetimibe will reduce HCV viremia perhaps allowing for viral clearance and that when included     in combination treatment regimens that EZE will increase HCV decline resulting in faster     viral clearance (i.e. shorter/cheaper direct-acting antiviral [DAA] therapy). To test these     hypotheses, the investigators will execute the following aims: (1) Assess the efficacy of EZE     monotherapy in chronically HCV infected and predict time to cure; (2) Assess the efficacy of     EZE as an adjunct therapy in chronically HCV infected patients undergoing currently approved     HCV DAA treatment.   "
24047|NCT02970903|"     The VitalPAD is a unified, portable and intelligent device that integrates information from     multiple patient monitors, mechanical ventilators, infusion pumps and clinical information     systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to     continuously monitor and coordinate care of critically ill patients.      This study will use a participatory design process to guide the design of an integrated     mobile device, followed by an evaluation of the proposed device in a simulated ICU setting.   "
24048|NCT02970890|"     Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear,     causes progressive joint deformity and loss of function leading to the indication of total     hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and     induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue     repair by modulating the inflammatory process and promoting pain relief. It can therefore be     part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain     of patients who underwent total hip arthroplasty. The study consisted of eighteen patients     who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours     after surgery. We divided the patients into two groups (n=9 each) placebo and effective     phototherapy. The patients were evaluated before and after phototherapy with 9 diodes,     applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J     total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the     cytokines TNF-α, IL-6 and IL-8.   "
24050|NCT02970864|"     Participants with a traumatic sensory nerve injury in the hand will be recruited to the     study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will     undergo repair with the Polynerve. Participants will be followed up regularly, observed for     device-related complications and to assess the return of sensory innervation.   "
24051|NCT02970851|"     The purpose of this study is to assess the effect of bosentan on the myocardial metabolism     and the dependent endothelial coronary vasomotoricity in patients presenting a PAH.      Hypothesis : Bosentan may improve right ventricular function by decreasing myocardial stress     and glucose metabolism. Patients may benefit from images with 18F-FDG PET / CT and 82Rb PET /     CT for an earlier assessment and optimal management of PAH.   "
24052|NCT02970838|"     To evaluate a standardized weight-loss program as treatment option for obesity and type 2     diabetes, changes in body composition and metabolic control are investigated in obese     patients with diabetes.   "
24053|NCT02970825|"     The investigators perform a prospective, randomized, clinical study involving students in     education with mood disorders and randomized to an intensive exercise program or a control     relaxation activity.   "
24054|NCT02970812|"     This randomized, placebo-controlled, double-blind, controlled study was designed to     investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist     circumference (WC) reduction in abdominal obese adults.      60 patients with abdominal obese, man with WC > 90 cm and woman with WC > 80 cm, received EMS     as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control     group (CG) 5 times a week for 12 weeks.   "
24055|NCT02970786|"     The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2     for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a     high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can     potentially be used in early response assessment to anti-angiogenic treatment.      This is a first-in-man study to test the radio tracer in cancer patients. Safety,     biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour     and 2 hours post injection).   "
24056|NCT02970773|"     The primary objective of this study is to investigate the pharmacokinetic and -dynamic     properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI)     individuals.      The secondary objective of this study is to determine the steady-state rivaroxaban activity     in cervical SCI individuals under long-term therapy.      Primary Objective In-house patients will be informed concerning the study and informed     consent will be collected.      During the screening day, in- / exclusion criteria will be assessed and a blood samples will     be taken for assessing haematology, clinical chemistry and coagulation parameters.     Furthermore, the evaluation day will be scheduled.      On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will     be introduced into a forearm or lower leg of each participant for the collection of blood at     the specified time points. Skin inspection for subcutaneous bleeding will be performed and     vital signs will be recorded. A blood sample will be taken for assessing haematology,     clinical chemistry and coagulation parameters.      Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer     Schering Pharma, Berlin, Germany).      Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after     and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity     will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12,     24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring     prothrombin time (PT) and activated partial thromboplastin time (aPTT).      Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed     30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.      Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during     their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be     assessed, and the patients will be informed concerning the study and informed consent will be     collected.      Blood samples will be taken for assessing haematology, clinical chemistry and coagulation     parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs     will be performed.      A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and     secondary outcome parameters.   "
24122|NCT02969915|"     This clinical trial will compare the effectiveness of integrated care centers vs. integrated     care centers plus HIV patient treatment incentives for achieving HIV treatment targets among     people who inject drugs and men who have sex with men in India. The investigators will also     assess cost-effectiveness and barriers and facilitators to implementation through targeted     mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key     populations in low to middle-income countries.   "
24057|NCT02970760|"     Adenomas are polyps of the colorectum that have the potential to develop into colon cancer.     However, some adenomas never become malignant tumors, or if so, progression from adenoma into     cancer takes a long time. As a result, screening colonoscopy programs were established in     order to detect and resect adenomas at an early stage. After resection, polyps should be sent     to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps     have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or     inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.      The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy     polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps.     The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be     inserted into the colon through a small working channel of the endoscope. Information on the     actual adenoma size is crucial as surveillance recommendations depend on the size of the     resected polyps. Moreover current guidelines contain the possibilities to disregard     hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that     diminutive hyperplastic polyps (< 5mm) do not necessarily require resection due to their     benign dignity. However, there is increasing evidence that large human bias effects exist in     estimating the size of polypoid lesions. For example, it has been shown that endoscopists     exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In     consequence the human bias problem might lead to wrong adenoma surveillance decisions.      There is no doubt that technical devices are needed which can support endoscopists in finding     the right declaration of polyp sizes. The aim of the current project is to create a computer     program that is able to automatically measure polyp sizes during colonoscopy.   "
24059|NCT02970734|"     Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed     as a disorder and serious enough to require treatment affects up to 10% of all adolescents by     the age of 16. The median age of onset is 11 years, making these disorders some of the     earliest to develop. Anxiety disorders can have serious negative effects on a young person's     personal relationships, school performance, and family life. These disorders may not be     discovered by adolescents, parents and health care providers. Even if anxiety disorders are     discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if     their anxiety is not treated properly. The investigators will carry out research to test     Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can     use this treatment from home via the computer. Breathe will include information materials and     personalized homework assignments to help anxious adolescents learn ways to manage anxiety.     More information can be found and www.TheBreatheStudy.com   "
24060|NCT02970721|"     The objective of the proposed project is to evaluate adverse maternal and fetal outcomes in     women who are treated and women who are untreated with mood stabilizing medication for     bipolar disorder during pregnancy, compared to women without bipolar disorder during     pregnancy.   "
24061|NCT02970708|"     To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating     anisometropic amblyopia.   "
24062|NCT02970695|"     Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the     improvement of sleep conditions and quality of life on the elders with insomnia.      Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on     the improvement of sleep conditions and quality of life in the elderly with insomnia.      Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and     exhibit poor sleep conditions are recruited.      Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT.     Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined     approach (LAT plus MAT).      The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven     specific auricular points.      Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end     of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.      Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed     effect modeling will be conducted as appropriate.      Expected results This study would advance our knowledge the optimum treatment protocol of AT     in the improvement of the sleep conditions of the elderly population.   "
24063|NCT02970682|"     This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in     combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.      Patients will be enrolled into one of three study arms (SFX-01 in combination with AI,     tamoxifen or fulvestrant) based on their current therapy.   "
24064|NCT02970669|"     The purpose of this study is to investigate the effects of initiation of sacubitril/valsartan     vs enalapril treatment on objective measures of both waking activity and sleep in subjects     with heart failure with reduced ejection fraction.   "
24065|NCT02970656|"     This feasibility/pilot study has three purposes. First, the investigators will determine the     feasibility of collecting saliva to measure stress biomarkers over three days at home in     youth. Second, the investigators will conduct a pilot study of the Teens.Connect Internet     program for youth with type 1 diabetes to determine whether changes in stress biomarkers     associate with self-reported perceived stress and HbA1c. Third, the investigators will     examine the gene-environment interaction of the top 14 targeted candidate genes and     epi-genome wide effects of teens' stress biomarkers and its influence on blood glucose levels     over time.   "
24066|NCT02970643|"     The purpose of this study is to determine whether Palonosetron and Olanzapine without     dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.   "
24067|NCT02970630|"     Prospective, single-arm, open-label, multicentre study with the principal aim to estimate     tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD     (Extended Criteria Donor) kidney grafts treated with Envarsus® prolonged release tablets in     combination with everolimus tablets.   "
24068|NCT02970617|"     This clinical trial studies how well ringing a bell on the final day of radiation therapy     works in improving the memory of distress in cancer patients. Ringing a bell on the final day     of radiation therapy may improve the memory of how painful the treatment was.   "
24143|NCT02969642|"     This study evaluates the treatment of migraine pain using low energy laser light to quench     migraine signals issuing from the sphenopalatine ganglion (SPG).   "
24144|NCT02969629|"     The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain     intensity and evoked cold clinical and experimental pain in patients with lumbar radicular     neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized     double-blinded manner.   "
24069|NCT02970604|"     Heart attacks and strokes are common causes of death worldwide. These events occur in part,     due to increased activity of platelets, which cause clotting (thrombosis) within heart and     brain blood vessels.      Anti-platelet therapies (e.g. aspirin) reduce the likelihood of platelet thrombosis and     therefore protect against heart attacks and strokes. However serious bleeding into the gut     and brain occurs in a number of individuals prescribed aspirin. Currently, there is no     reliable method for assessing the relative risks of thrombosis versus bleeding in individual     patients prior to or during aspirin therapy.      We have recently discovered that individuals with a particular genetic make-up, those with     genetic variants in two genes called PPARGC1β and CNTN4, demonstrate more active (sticky)     platelets. We then found that these same individuals suffered a greater number of     cardiovascular events. Interestingly, low dose aspirin suppressed the excessive platelet     stickiness and protected against heart attacks and strokes in these patients.      In this project, we aim to confirm and extend the above findings. We hope that testing for     PPARGC1β and CNTN4 genetic variants will allow us to identify which patients will benefit     from low dose aspirin therapy - i.e. receive protection from heart attacks and strokes, but     not suffer any bleeding complications.   "
24384|NCT02966496|"     This trial is designed to compare the biocompatibility and long-term visual outcomes of the     Tecnis Z9001 and Acri.LISA 366D multifocal IOLs used for the treatment of senile cataract.     The aim is to provide a safer biomaterial for senile cataract treatment, achieving better     postoperative visual quality and fewer complications.   "
24070|NCT02970591|"     Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is     considered to trigger symptoms associated with the clinical picture of IBS, and dietary     treatment is thus believed to relieve the symptoms of IBS. As the disease is very     heterogeneous in its manifestation, different treatment options might be indicated depending     on the predominant symptom. To investigate the response to different dietary treatment     options, a randomized controlled intervention trial will be carried out in adult patients     (>18 y) with IBS according to Rome III criteria. The aim of this study is to compare the     response to two different dietary treatments or optimized medical treatment.   "
24071|NCT02970578|"     To explore the accuracy of 3D printed module assisted minimally invasive lumbar pedicle screw     placement using Quandrant system, and verify its feasibility of reducing error rate of screw     placement and postoperative complications.   "
24072|NCT02970565|"     The purpose of this current study is to investigate the efficacy of a group model of Family     Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The     behavioral, neurobiological and clinical insights gained from this project may eventually     lead to better treatment of emotional, behavioral and developmental disorders. The     investigator hypothesizes that the children who are treated with Family Nurture Intervention     (FNI), which incorporates interactive touch with vocal soothing, and family practice in     comforting, will show increased emotional connection and mother child co-regulation with     better results in the outcome measures in the short term and long term.   "
24073|NCT02970552|"     More than 1.5 million HIV-infected women become pregnant each year. Approximately half have     access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB).     Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that     should be studied in this high-risk population. This pilot study will provide critical     insight into the feasibility of a phase III trial by determining whether women are willing to     participate, to adhere to study drug, and to complete follow-up.   "
24074|NCT02970539|"     This is a nonrandomized, open-label, single group assignment, safety, tolerability and     pharmacokinetic (PK) study to determine the MTD and optimal dosing regimen of Oraxol in     combination with ramucirumab.   "
24075|NCT02970526|"     This project will evaluate the neurotoxic effects of oxaliplatin. Oxaliplatin is considered     the most neurotoxic chemotherapy, and at the origin of peripheral neuropathies. These     neuropathies remain a problem in oncology because currently no prevention strategy has proved     effective and only duloxetine seems to have a therapeutic benefit in improving symptoms. In     the case of oxaliplatin, neuropathy forced oncologists to reduce the dose or to stop the     chemotherapy, potentially degrading the oncological prognosis.      Objective of this study will be to assess, on a large number of patients (n> 500) who     completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5     years after the end of chemotherapy. Furthermore, this study should enable an assessment of     the relationship between the intensity of neuropathy and comorbidities, such as anxiety and     depression and health related quality of life of patients.   "
24076|NCT02970513|"     The purpose of this study is to determine whether the presence of pathogenic Escherichia coli     in colon is associated with psychiatric disorders.   "
24077|NCT02970500|"     Cancer-related cognitive Impairment, (CRCI) commonly referred to as chemo brain or brain     fog—impact severely on the Quality of Life (QoL) of cancer survivors, It still remains     underdiagnosed and challenging to treat. One of the treatment options is the use of     psychostimulants such as Methylphenidate (MP), but well-designed clinical trials to test its     efficacy are limited. We will conduct a phase II study with a mixed method design to explore     the preliminary efficacy of MP to improve cognitive function and Quality of life in breast     cancer patients after treatment with chemotherapy and/or radiotherapy and determine the     parameters needed for designing a phase III study. This study will include two phases: Phase     one: randomized placebo-controlled clinical trial, phase 2 open-label trial.   "
24078|NCT02970487|"     The purpose of this study is to determine the refractive outcomes and optimize the clinical     features of a new intraocular lens intended to treat the senile cataract.   "
24079|NCT02970474|"     Some radiation therapy treatment plans require the use of boluses. Boluses are placed     directly on the skin overlying the area to be treated. The radiation beam interacts with the     bolus before entering the body and ensures that the correct radiation dose reaches your     tumor. The purpose of this study is to determine whether the shortcomings of conventional     bolus preparation can be overcome by using a 3D printer. CT scans of the body can be used to     create 3D models for boluses. The 3D models can then be printed into plastic boluses using a     3D printer. Preliminary studies have shown that 3D printed boluses conform to body contours     better and allow for more precise control over radiation dose. In this study, both a     conventional and 3D printed bolus will be made. The Investigators will then simulate     treatment with both boluses to determine which bolus will result in more optimal treatment     for the participant. The superior bolus will be used in the participant's treatment.   "
24080|NCT02970461|"     A randomized controlled trial design is used to test the efficacy of gamification elements to     drive user behavior in a personal health record.   "
24081|NCT02970448|"     The investigators of this study want to see if shortening the total treatment time for brain     tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser     Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For     participants, the total time of treatment from surgery to the end of radiation and     chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total     treatment to 7 weeks.      To shorten the total treatment time, investigators want to see if it is safe to start     radiation with chemotherapy within 5 days after surgery. Usually patients start their     radiation with chemotherapy about 21-28 days after the surgery.      Shortening the total time of treatment may allow investigators to kill the cancer cells more     effectively.   "
24082|NCT02970435|"     The purpose of this research is to look at how educational videos provided by doctors might     affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs     surgery care. Patients will be randomized to either: 1) a group that receives educational     videos in addition to standard-of-care written and verbal instructions or 2) a group that     receives only standard-of-care written and verbal instructions.   "
24083|NCT02970422|"     The purpose of this study is to distribute a questionnaire created for individuals living     with chronic obstructive pulmonary disease (COPD) to assess their activities, participation,     and healthcare and COPD-related research priorities. The data collected will be compared     across diagnosed COPD stages and disease severity to determine the extent to which adults     with COPD participate in the listed activities and identify their primary research and     healthcare related priorities. The questionnaire was originally developed based on past     research then verified by a panel of COPD and participation experts; as well as, individuals     living with COPD in the form of focus groups. The questionnaire will now be administered to     200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where     clinical data for each participant will be available. This phase will help establish the     reliability of the questionnaire.   "
24084|NCT02970409|"     A clinical, prospective. controlled and randomized study with patients with a peripheral     venous catheter. Patients will be randomized to either receive heparin or saline. The     investigators will monitored the clinical out come to further evaluate catheter colonization     rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.   "
24085|NCT02970396|"     This is an investigation of adult individuals with epilepsy, and involves educational and     behavioral interventions intended to enhance treatment adherence and self-management.      The investigators are adapting a self-management intervention that they developed in a     previous study to individuals with epilepsy and a history of negative health events (NHEs),     such as accidents and emergency department (ED) visits, diminished quality of life and poor     mental well-being. The intervention Self-management for people with epilepsy and a history     of negative health events (SMART) is intended to reduce NHEs and improve quality of life in     people with epilepsy associated with historically disadvantaged groups.   "
24086|NCT02970383|"     This study evaluates the effect of larger or smaller opioid prescriptions following minor     surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and     leftover narcotic.   "
24087|NCT02970370|"     The primary study aim is to depict the demographics, clinical and para clinical features of     patients attending five tertiary referral multiple sclerosis (MS) centers in Egypt.      This requires effective and unified pooled registries to extract data from with a     standardized, sufficient and high quality clinical, magnetic resonance imaging (MRI) data,     neurophysiological data and body fluids.      Investigators want to shed light on the challenges that face both physicians and patients in     the area of diagnosis and treatment   "
24088|NCT02970357|"     The needs of children and teens with type 1 diabetes are very specific and different from the     adults with type 1 diabetes. Many organizations such as the World Health Organization or the     International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic     education when it comes to children with type 1 diabetes.      This study aims to evaluate the impact of a therapeutic education program on theoretical     knowledge of the disease and also on quality of life, on biological and clinical indicators.   "
24089|NCT02970344|"     The proposed randomized clinical trial evaluates a diabetes coping skills training (DCST)     intervention for improving breast cancer survivors' abilities to manage symptoms and adhere     to recommended diabetes self-management. The telephone-based DCST protocol integrates three     key strategies to reduce symptoms and improve diabetes self-management: coping skills     training for managing symptoms, adherence skills training, and healthy lifestyle skills     training. The investigator will test the effects of the DCST intervention by comparing it to     diabetes education alone. Physical symptoms, psychological distress, diabetes self-management     behaviors, and self-efficacy for managing symptoms and diabetes self-management will be     assessed at baseline and 3, 6, and 12 months. Physical activity (i.e., daily steps and     distance) will be assessed using wireless activity trackers (Fitbit) and data will be     obtained from home blood glucose monitoring devices. Fasting insulin, fasting glucose, and     glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.   "
24090|NCT02970331|"     A multi-center, open-label study that will evaluate the safety/tolerability and     pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50     evaluable adolescents 12 to < 17 years of age.   "
24091|NCT02970318|"     This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in     combination with idelalisib or bendamustine in previously treated subjects with chronic     lymphocytic leukemia (CLL).   "
24092|NCT02970305|"     To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive     placebo in the treatment of the negative symptoms of schizophrenia   "
24093|NCT02970292|"     To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive     placebo in the treatment of schizophrenia   "
24145|NCT02969616|"     This prospective, post-market, open label clinical study is designed to examine the lumbar     fusion rate at 24 months post operative in subjects who have undergone a lumbar fusion     surgery using Trinity Elite with or without local bone.   "
24433|NCT02965846|"     The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1%     AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry     eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice     daily in patients with EDE   "
24105|NCT02970136|"     The purpose of this research study is to determine the best way to increase screening for     cervical cancer, colorectal cancer, HIV, and Hepatitis C among underscreened Hispanic,     Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The     investigator will compare home testing led by a community health worker (CHW) versus clinic     testing guided by a CHW. Community Health Workers are people who have undergone several weeks     of community outreach and health education training. During the study period the participant     will continue to receive all of their regular medical care from their regular health care     providers. If the participant does not have a health care provider, the Community Health     Workers would be able to help in referring the participant for care at a local health care     clinic located in their community.   "
24403|NCT02966249|"     The present study is designed to evaluate and compare the efficacy of intrathecal     dexmedetomidine (DEX) as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's     intravenous administration, without loading dose, additionally to spinal anaesthesia, in     patients undergoing total knee arthroplasty.   "
24094|NCT02970279|"     Depression is one of the most common mental health disorders and it is estimated up to 50% of     patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis'     outcome. However, there is limited research understanding this population, meaning a     considerable number of people continue to suffer. The purpose of this study is to 1) identify     depression stasis prevalence and predictors in an existing evidenced-based group treatment     for depression, 2) run a clinical trial to test whether an embedded intervention based on     theoretical and clinical practice evidence can help reduce patient depression stasis and     drop-out rates and 3) understand what aspect of therapy produces change (or prevents change     in stasis). The study will be based on behavioural activation (BA) therapy delivered in an     eight-session group format in an Improving Access to Psychological Therapies (IAPT) service     in the United Kingdom. BA is one of the most effective psychotherapies available for     depression and focuses on helping patients to increase their engagement with valued     activities to help break out of the cycle of depression. Firstly, an archived anonymised     dataset of routine depression measures from patients who have previously received the     existing group BA treatment will be analysed. Secondly, the group BA treatment delivered to     patients in 2017 will be enhanced with two treatment augmentations. One augmentation will     target stasis outcomes through the addition of specific 'if-then' planning (known as     implementation intentions) when setting between-session homework and the other augmentation     will target patient drop-out by informing patients about group BA effectiveness and     therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in     the trial will be compared with the archived outcomes to see if the intervention has had an     effect and the role of engaging in valued living as a mechanism of change for depression     symptoms will be examined. It is hypothesised that a) 50% of patients who have received the     existing BA group treatment for depression will have a stasis outcome, b) there will be a     significant reduction in depression stasis outcomes and drop-out rate following the enhanced     BA group treatment delivered in the trial and c) engagement in valued living will have a     mediating effect on outcome for responding patients following the enhanced BA group treatment     but the effect will not be present for patients with a stasis outcome.   "
24095|NCT02970266|"     The main objectives of this study are:        1. Improve genetic counseling by establishment of prevalences of each of genetic subtypes          within a expanded population of patients with LCA taking into account ethnicity of          families.        2. Confirm, refine or modify the genotype-phenotype correlations.        3. Edit important recommendations for:             -  The clinical and paraclinical exploration of a new patient based on genotype,               especially for extraocular explorations, to book at certain genetic subtypes             -  Prenatal care of a couple.             -  Directing families to a therapeutic protocol in progress or in development.        4. Individualize a panel of families without a mutation in the known genes and identify new          genes responsible.   "
24096|NCT02970253|"     Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus     capsular flap retention.      Prospective study design comparing clinical data in randomized THA patients who either had     capsular resection or capsular flap retention.   "
24097|NCT02970240|"     Circumstantial evidence suggests that patients diagnosed with myalgic encephalopathy/chronic     fatigue syndrome (ME/CFS) perform worse on day 2 in a 2-day consecutive cardiopulmonary     exercise test (CPET). The aim of this study is to examine if CPET can distinguish between     ME/CFS patients and healthy controls.   "
24098|NCT02970227|"     cohort of cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy)     recruited at baseline by the SFB-TR19 project. Standardized protocols used for the assessment     of medical history and examinations, laboratory biomarkers, and the collection of various     biosamples for biobanking purposes.   "
24099|NCT02970214|"     Follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in     CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized     Medicine). Standardized protocols will be used for the assessment of medical history,     laboratory biomarkers, and the collection of various biosamples for bio-banking purposes.     Comparisons with the general background population will be performed.   "
24100|NCT02970201|"     Dialysis treatment non-adherence is a prevalent problem among the end-stage renal population     receiving chronic hemodialysis. The complications associated with missed or shortened     dialysis sessions are serious and frequently require emergent medical care or     hospitalization. Previous studies have shown that electronic messages have significantly     improved attendance rates in a primary care setting, but these messages have not been     validated in the chronic dialysis population.      An electronic intervention has been developed by Epharmix, a WUSTL IDEA Labs     (ideas.wustl.edu) team, which has the capacity to use automated SMS text messages and/or     phone calls to notify patients prior to each upcoming appointment, as well as alert a     designated patient advocate. Patients receiving the messages are provided with key contact     information for a dialysis rescheduling phone line, transportation resources, social work     services, etc. They may also receive instructions on what to do if they are experiencing     physical symptoms and need educational facts about dialysis. In particular, the intervention     is designed to demonstrate to patients that the center cares and is concerned for their     health and wellbeing. This intervention may potentially improve patient adherence to their     scheduled sessions, increase patient satisfaction with their treatment, and prevent medical     complications associated with missed dialysis appointments.      This study aims to determine whether an electronic intervention, which sends SMS text     messages or phone calls of key dialysis treatment information, is able to improve dialysis     treatment session attendance among dialysis patients with a history of poor attendance. We     secondarily aim to identify the factors that may be barriers to dialysis treatment session     attendance and the emergency department or hospital utilization associated with missed     dialysis treatments.      Patients will be prospectively identified, recruited, and randomized into two groups. Group A     will receive the electronic intervention prior to their appointments; Group B will not     receive any electronic intervention. After 8 weeks, crossover will occur for both groups and     the study will continue for an additional 8 weeks. Participants' clinic records will be     reviewed to determine the numbers of missed and attended appointments, as well as records of     ED visits and hospital admissions. Subjects will be asked to complete a post-study     satisfaction questionnaire.   "
24101|NCT02970188|"     The purpose of this study is to assess the safety and efficacy of time-restricted feeding     (eating within an 8-hour window) for improving physiological function (vascular, motor,     cognitive and metabolic function) in healthy middle-aged and older adults.   "
24102|NCT02970175|"     The diagnostic yield of flexible bronchoscopy for the diagnosis of lung cancer depends on the     location and the histological type of the lesion, as well as on the number of biopsy samples     performed. The increasing number of sampling is also important to provide material for     molecular assessment of lung cancer. The French National Institute for Cancer recommends a     number of 5 biopsies in order to reach a diagnostic yield of 88%. However, as increasing the     number of bronchial biopsies comes with a higher risk of bleeding, the management of     endobronchial bleeding may be determinant for the diagnostic yield.      The most recent recommendations of the British Thoracic Society for the management of     bronchial bleeding, after bronchial or transbronchial biopsy, are to inject 5 to 10 mL of     1/10000 diluted adrenalin, or cold saline serum (04°C.). The French guidelines also include     the use of endobronchial terlipressin, which has local vasoconstriction effect. After     endobronchial administration of terlipressin, plasmatic concentrations are low, and are not     clinically relevant.      The hypothesis of this clinical trial is that endobronchial instillation of terlipressin     before sampling endobronchial tumor will limit the endobronchial bleeding and allow to     increase the number of biopsies performed and, eventually, the diagnostic yield.   "
24103|NCT02970162|"     This study evaluates the effect of withdrawing amifampridine phosphate treatment from     patients with LEMS. One half of the patients will continue to receive amifampridine phosphate     and the other half will receive placebo, during this double-blind study.   "
24104|NCT02970149|"     Background: Inflammatory bowel disease (IBD) is a group of disorders characterized by chronic     inflammation of the gastrointestinal tract with remissions and relapses. The two most common     subtypes are Crohn's disease (CD) and ulcerative colitis (UC). In 2012, the burden-of-illness     report from the Crohn's and Colitis Canada estimated that the direct medical costs of IBD in     Canada were over one billion dollars, primarily funded through the Canadian public healthcare     system.      Many life style-related factors may play an important role in the pathogenesis of IBD and can     contribute to trigger disease relapse, but several of these factors are poorly understood.     These factors may include sleep disturbances. Data on sleep disturbance in children with IBD     are limited. Sleep deprivation has been shown to cause reactivation of colitis in animal     studies but similar data are lacking in humans especially in children.      Hypothesis: In children with IBD, high scores for a sleep disturbance screener will be     positively associated with IBD relapse Objective: To develop a non-invasive non-costly tool     to screen for relapses in pediatric IBD patients through examining the association between     sleep disturbances and disease relapse in children with IBD Methods: This study will     incorporate an observational prospective design. Participants: Participants will be 90     children (ages 8-17 years ) under the care of the Pediatric IBD Program at the Children's     Hospital, Winnipeg. All participants will have an established diagnosis of IBD.      Measures: Sleep disturbances will be assessed using a sleep diary. Patients will be asked     complete a daily sleep diary in the week preceding their clinic appointment. The sleep diary     will provide information about latency to fall asleep, number of awakenings, duration of     awakenings, total sleep time, sleep quality, and sleep efficiency.      Mucosal inflammation will be assessed by measuring fecal calprotectin and clinical disease     activity will be measured Pediatric Crohn's disease activity index (PCDAI) for CD and     pediatric ulcerative colitis activity index (PUCAI) for UC at clinic visits     Anxiety/Depression: As anxiety and depression are often comorbid with disturbed sleep, levels     of symptoms in both domains will be assessed at clinic visit using the Child and Parent     Report Versions of the Spence Anxiety Scale and the Child Depression Inventory (v. 2).      Procedure: Upon obtaining informed consent, each participant will complete 7 days of sleep     diary recording in the week prior to their clinic appointment. During the clinic visit, the     PCDAI or PUCAI, Spence Anxiety Scales, Child Depression Inventory will be completed. Fecal     samples will be collected for fecal calprotectin measurement as a surrogate marker for     mucosal inflammation. Other investigations will include blood samples for serum hemoglobin,     serum albumin, and inflammatory markers. Stool samples for infection screen will also be     collected to exclude any possibility for gastrointestinal infection on top of IBD.A second     clinic visit will be scheduled 3 months later and the whole process will be repeated in the     second visit.      Regression analysis will be performed to examine the association between sleep disturbances     and disease activity, characteristics and patients' demographics      Outcomes:      Primary outcome: Cut-off score of a sleep screener that is associated with disease relapse     (as diagnosed by fecal calprotectin value of >100 microgram/gram of stools) in children with     IBD Secondary outcomes: 1. Correlation between sleep disturbance scores and clinical disease     activity indices (PCDAI and PUCAI). 2. Identification of which sleep component (sleep     duration, latency, fatigue, subjective quality) is the best at detecting a disease relapse.      3.Identification of whether sleep disturbance more accurately predicts relapse for CD than     for UC.   "
24106|NCT02970123|"     Sedentary behavior is engaging in activities in the seated or lying position that barely     raise the energy expenditure level and has emerged as an important risk factor for obesity,     diabetes, cardiovascular disease and mortality.      The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in     Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by increasing     casual walking duration and thereby, increase physical activity energy expenditure.   "
24107|NCT02970110|"     The objective of this study is to acquire human specimens from subjects undergoing routine     endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.   "
24108|NCT02970097|"     The purpose of this study is to compare infraclavicular brachial plexus shot single shot     block to local infiltration done in adult patients having wrist arthroscopy surgery. Visual     analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours     post operatively will be used for comparison.   "
24109|NCT02970084|"     Clinical study single center, prospective, randomized, controlled (vs. no supplement),     open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12     months will not know the treatment given to the patient, because the diagnostic test in     question is considered operator-dependent), a parallel group, which aims is evaluate the     reduction in the level of calcium in the carotid artery and the carotid atherosclerotic     plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid     bifurcation with a range of 40-60%.   "
24110|NCT02970071|"     The objective of this study is to use of STIC technology to assist the traditional     echocardiography to dignose the fetal congenital heart disease accurately and then to provide     a basis for prenatal counseling.   "
24111|NCT02970058|"     Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following     gynecological surgery.   "
24112|NCT02970045|"     This research trial collects biological samples and clinical information to create a     repository of data from patients with cancer or a predisposition for cancer. Combining     genetic information from biological samples and clinical data may lead to more knowledge     about why certain cancers respond to treatment and help create more personalized medicine.   "
24113|NCT02970032|"     The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500     units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis     in patients undergoing microvascular surgery. Additionally, a pilot protocol has been     developed to titrate these heparin infusions to ensure patients have sufficient VTE     prophylaxis. All patients will be enrolled in the observational arm of the study and receive     anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the     interventional arm of the study and receive real time heparin infusion dose adjustments per     the pilot protocol. The primary outcome measured will be the percentage of patients with     anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 500     units/hour.   "
24114|NCT02970019|"     This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease   "
24115|NCT02970006|"     The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg     illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a     custom-designed virtual reality leg scenario) will lead to controlled analgesia induction,     boosting analgesic effects obtained with standard SCS treatments and will further be     associated with changes in the perception of the affected body part.   "
24116|NCT02969993|"     Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of     operated patients using the voice handicap index scale   "
24117|NCT02969980|"     This study is conducted to evaluate the feasibility and efficacy of post-transplantation     cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic     hematopoietic cell transplantation (HCT) in patients with myelodysplastic syndrome (MDS).   "
24118|NCT02969967|"     The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in     improving upper extremity recovery for people in the early phases of rehabilitation post     stroke. The objectives of the study are:        1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity          function, strength, movement, spasticity and self-perceived occupational performance, in          addition to conventional therapy, with continued use immediately after discharge from          inpatient stroke rehabilitation and while waiting for outpatient occupational therapy          services        2. to explore the relationship between the participants' level of self-efficacy and use of          the SaeboFlex orthosis in the home environment        3. to explore the participants' experience of use of the SaeboFlex orthosis in the home          environment.   "
24119|NCT02969954|"     Racial and ethnic minorities with type II diabetes in the US are more likely to develop     complications and die from the disease than the general population. The foreign-born subset     of this population is less likely to adhere to diabetes care recommendations than US-born     patients, thereby placing them at higher risk for complications. In our previous pilot     project, eight stories were assessed through preliminary multi-site intervention for     acceptability and efficacy in diabetes management among Latino and Somali patients with     poorly controlled type II diabetes. The goal of this project is to evaluate a new format for     delivery of a culturally tailored digital storytelling intervention by incorporating a     facilitated group discussion following the videos, for management of type II diabetes in     Latino communities.   "
24120|NCT02969941|"     To investigate the treatment effect of continuous transcranial magnetic stimulation on     patients with Parkinson disease, and the underlying neural mechanism by functional MRI   "
24133|NCT02969772|"     The aim of the study was to evaluate the tetraplegics movement strategies, assisted by     Neuromuscular Electrical Stimulation (NMES), on the reach and palmar (RP) grasp to different     weights objects.Tetraplegics had their RP grasp movement captured by four infrared cameras     and 6-reflexive markers attached on the trunk and right arm, assisted or not by NMES, in the     triceps, extensor carpi radialis longus, extensor digitorum communis, flexor digitorum     superficialis, opponens pollicis and lumbricalis muscles. The grasp was made in three     cylindrical objects (different diameters and weights) placed in trunk midline in an     equivalent distance of the arm's length. The patients were able to reach and made palmar     grasp in all cylinders using the stimulation sequences assisted by NMES.   "
24123|NCT02969902|"     Venipuncture is one of the most common iatrogenic painful and stressful procedures performed     on children. Interventions aimed at reducing the distress related to this experience are     widely and strongly recommended. Pain and anxiety management is even more essential because     it may modify children's memory for procedural pain and the subsequent acceptance of later     health care painful interventions. Distraction is the most studied psychological technique to     relieve venipuncture related pain and distress, with a strong evidence supporting its     efficacy in children and adolescents.      In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ     Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines     distraction and physical analgesia (vibration and cold) and it was positively tested during     venipuncture, intravenous cannulation and painful injections in children. Even though its     efficacy it's well established, most of the published trials did not compare Buzzy with other     interventions, so that little data are available about its usefulness compared with other     distractions techniques.      Hand-held computers are reusable tools, which offer a technological-based active distraction.     There is evidence supporting their used during painful procedures such as venipuncture and a     recent published study showed that hand-held computer distraction was as effective as     nurse-led passive distraction techniques in children.      The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in     pain relief during venipuncture.   "
24124|NCT02969889|"     bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial.     Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.   "
24125|NCT02969876|"     The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with     major depressive disorder.   "
24126|NCT02969863|"     To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal     and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years     of age) subjects with type 1 diabetes in a random-order crossover study versus usual care     with an insulin pump with and without remote monitoring of hypoglycemia.   "
24127|NCT02969850|"     Although the African-American (AA) population tends to have lower serum 25(OH)D levels     compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans     are harmful. In fact, skeletal health is superior in AA. It is clear that total serum 25(OH)D     concentrations do not reflect the same risk/benefit ratio in AA compared to white women and     is, therefore, an inappropriate biomarker in this population.      The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio     (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The     investigators propose a six month randomized double blinded study.   "
24128|NCT02969837|"     This study will be a multi-center, open-label, Phase 2 study where newly diagnosed Multiple     Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 55     subjects will be enrolled. Time to progression or death will be calculated from the date of     first treatment on protocol until the date of disease progression or death from any cause.     Patients can expect to participate between 12-24 cycles. The primary endpoint will be the     rate of response by next generation gene sequencing at the end of 8 cycles among     non-transplant candidates and transplant candidates who agreed to defer transplant.   "
24129|NCT02969824|"     This study will investigate the effect of standardized aerobic exercise (AE) compared to rest     on clinical recovery from sport-related concussion (SRC) within the post-acute phase of     injury. Participants will be randomized into one of two groups: (1) Aerobic Exercise Group:     participants will complete a total of eight exercise sessions over the course of 11 days,     starting at Day 6 post-injury; (2) Usual Care Group: individuals will undergo a period of     physical rest until symptoms spontaneously resolve. For the purposes of this study, rest     will be defined as the avoidance of any activities beyond those of daily living, including     participation in sport and physical activity.   "
24130|NCT02969811|"     Blood transfusion is an expensive and finite resource and optimum transfusion threshold in     surgical patients is yet to be defined. Patients commonly receive blood transfusions to     reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the     kidneys), but this treatment may have important adverse effects including postoperative     infection. Patients undergoing surgery for fractured neck of femur are often elderly, with     co-morbidities and a high risk of postoperative complications, including MI and AKI. We     propose to conduct a study with the following aims:        1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for          fractured neck of femur.        2. To use clinical and biochemical data to measure the incidence of perioperative cardiac          and kidney injury in this group.        3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints          in a future prospective randomised trial of perioperative transfusion.   "
24131|NCT02969798|"     HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct     pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the     specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally     prevent the progressive beta cell failure and development of overt type 2 diabetes.   "
24132|NCT02969785|"     The relevance of this study is given by the feasibility to assess the effect of an     intervention program based on the postural control and trunk neuromuscular activity,     comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes     with low back pain. The main outcomes will be computed by electromyography measurement so     that to assess the trunk neuromuscular activation pattern as well as by force platform     parameters for determining of postural control. Clinical symptoms such as pain intensity,     perception of disability and fear and avoidance will also be computed. This is the first     study to compare two intervention methods using the main biological outcomes related to trunk     neuromuscular function.   "
24146|NCT02969603|"     The present study is conceived as a pilot study aimed to determine the efficiency of the     newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid     scan technique for muscular activity evaluation, creation of anatomic images of muscle     activity and resolution of metabolic activity distribution within exercising skeletal muscle.   "
24434|NCT02965833|"     The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE®     multipurpose contact lens solutions in presbyopes currently wearing soft contact lenses and     experiencing symptoms of dryness.   "
24134|NCT02969759|"     INTRODUCTION: Amyotrophic Lateral Sclerosis (ALS) is a degenerative disease of the motor     neurones of the brain and the spinal cord. The pathophysiological mechanisms of the disease     remain unknown. The average age of onset of ALS is about 60 years old, and the mean survival     of patients is about 2 years. The disease is responsible for a progressive paralysis leading     to death from respiratory failure. The only treatment available is the Riluzole, with a very     modest efficiency on the progression of the disease. ALS is the third neurodegenerative     disease, affecting 6000 persons in France, 150 000 in the world. Among the protagonists     involved in the occurrence of the disease, mitochondrial perturbations and protein     accumulations seem to be central elements.      OBJECTIVES: To precise the implication of energy and protein metabolism in the sporadic forms     of ALS, to identify potential biomarkers of the disease and to test new therapies.      METHODS: The investigators will study cell growth, bioenergetics, mitochondrial dynamics,     free-radicals production, presence of cytoplasmic inclusions, cytoskeleton structure and     stress response in primary skin fibroblasts obtained from sporadic ALS patients. The study     will be conducted over a period of three years in 3 centres specialized respectively in motor     neuron diseases, mitochondrial metabolism and neuronal cytoskeleton.      PROSPECTS: If the investigators achieve to identify differences between ALS fibroblasts and     controls, the results will be key elements to reinforce the hypothesis of a systemic disease     with an important metabolic participation, to better define ALS pathophysiological     mechanisms, to find potential biomarkers and to test new therapies.   "
24135|NCT02969746|"     This is a prospective, multicentric, randomized, open labeled superiority trial      This study aims to evaluate the efficacy of oral activated charcoal for improving elimination     of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive     procedure delayed to this anticoagulant treatment.      The primary outcome is the anticoagulant's half life. Plasma concentration will be measured     by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).      A total of 140 patients will randomly be assigned to the charcoal or control group,     stratified according to their anticoagulant drug.   "
24136|NCT02969733|"     Recent clinical studies in abdominal surgery have shown that the use of Xylocaine®     parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g /     ml, had an analgesic effect and decreased postoperative morphine consumption.      This study aims to evaluate the activity of Xylocaine® and ketamine separately administered     parenterally, in terms of postoperative morphine consumption and decrease incidences of     postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the     placebo group.      The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface     scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature     of these criteria in the occurrence of chronic pain.   "
24137|NCT02969720|"     The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily     supplemention on diagnosis criteria of metabolic syndrome.   "
24138|NCT02969707|"     The investigators plan to use functional neuroimaging (fMRI) to understand the brain systems     affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial     magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with     fibromyalgia, a chronic pain condition. The investigators will measure the effect of rTMS-     augmentation on the brain networks underlying hypnotizability, as well as the effect of     rTMS-augmentation on hypnotic analgesia networks. The investigators hope to demonstrate that     a combination of these psychological and neuromodulatory treatments will be more effective     than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the     efficacy of hypnotic analgesia and hopefully creating a new treatment modality for     individuals suffering from pain syndromes such as fibromyalgia pain.   "
24139|NCT02969694|"     Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.      Evaluation using an hetero-assessment questionnaire about the link between hypersexual     disorder and the use of synthetic cathinone.      Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and     the medico-psycho-social consequences of those practices.   "
24140|NCT02969681|"     Preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF     mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA     impairs tumor growth in Apc/KRASG12D mutant mice. Previous phase Ⅰ studies have found that     high dose iv AA is well tolerated in cancer patients.This protocol is a phase Ⅲ, study of     ascorbic acid (AA) infusions combined with treatment with FOLOX/FORFIRI +/- bevacizumab     versus treatment with FOLFOX/FORFIRI +/- bevacizumab alone as first-line therapy in patients     with recurrent or advanced colorectal cancer with mutant RAS.   "
24141|NCT02969668|"     The primary objective of study will be to evaluate the effectiveness of interferon-free     direct acting antivirals (IFN-free DAAs) in the treatment of chronic hepatitis C virus (HCV)     among patients in opioid-substitution treatment (OST). We hypothesize that rates of sustained     virological response will be comparable to non-OST populations. Secondary objectives include     the evaluation of safety data, patients` adherence and patient reported outcome measures like     functioning (disability), satisfaction with the treatment, health status, general health     perceptions and health-related quality of life.   "
24142|NCT02969655|"     Daprodustat is a drug that is currently being developed as a treatment for renal anemia .     This study is to evaluate the efficacy and safety of daprodustat following a switch from     erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are     currently treated with ESA. The primary objective is to demonstrate non-inferiority of     daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind,     active-controlled, parallel-group, multi-center study. The total duration of the study will     be approximately 58 weeks including screening and follow-up.   "
24157|NCT02969460|"     The Neurotrack Virtual Cognitive Health Study is a 6-month long, prospective,     intent-to-treat, study that aims to evaluate the impact of the Neurotrack Virtual Cognitive     Health Coaching Program on cognitive ability, anxiety and depression, and lifestyle behaviors     for individuals who show signs of subjective cognitive decline. After the first 6 months of     the study, the study researchers may extend the study and provide participants with the     opportunity to continue participating in the study for an additional 6 months.   "
24147|NCT02969590|"     The purpose of this study is to help us determine how hormones impact the production of     cervical mucus which is a fluid secreted by the opening of the uterus, also called the     cervix. During a normal menstrual cycle, cervical mucus changes in response to two hormones     that the ovaries make: estrogen and progesterone. Many of the birth control methods women use     thicken mucus and make it less likely for sperm to enter the uterus. The goal of this study     is to better understand the effects estrogen and progesterone have on the cervical mucus in     the body. To do this, the investigators will be using a drug that suppresses natural hormone     production for 3 months. Estrogen and progesterone will be artificially replaced to better     understand their effects. The investigators will also be studying the effect of a common     birth control pill that may work by thickening cervical mucus. Last, the investigators will     study some of the cells in the cervix that produce mucus.   "
24148|NCT02969577|"     The purpose of this study is to learn if lifestyle changes and counseling along with standard     medical care, compared to standard medical care alone, can prevent heart problems and     diabetes in men who are receiving ADT for prostate cancer treatment.   "
24149|NCT02969564|"     The number of metastases in a patient with primary or recurrent prostate cancer has major     prognostic implication.      The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR     with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for     determining the presence or absence of bone lesions in prostate cancer patient, with up to     five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold     standard will be a combination of clinical follow-up, additional imaging and biopsy, as     indicated by the multidisciplinary discussion at the tumor board. The findings from     whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will     be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant     or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.   "
24150|NCT02969551|"     Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of     sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not     eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE).     The frequency and obstructions patterns in different sleep stages are assessed. In addition     obstruction patterns detected with AG are compared with DISE examination in the selected     cases.   "
24151|NCT02969538|"     The aim of this study is to evaluate the effect of shortening the etching time on the     18-month clinical performance of resin composite restorations in primary molars after partial     carious removal. This randomized clinical trial will include subjects (5-10 year-old     children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will     consist of 70 primary molars presenting active cavitated carious lesions (with radiographic     involvement of the outer half of the dentin), located on the occlusal surface. The sample     will be randomly divided into two groups according to the etching time of the dentin prior     adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds)     and half-reduced etching time (7 seconds). The restorations will be clinically followed every     6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival     estimates for restoration longevity will be evaluated using the Kaplan-Meier method.   "
24153|NCT02969512|"     Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility     impairment. Given the boom in the older demographic it is not surprising that there is an 11%     increased demand for replacement every 5 years in Canada. Health promotion interventions,     such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical     outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient     discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT)     that will assess feasibility indicators and clinical outcomes of online prehab education     modules compared to a traditional in-person education. The feasibility indicators (process,     resource, management, and treatment issues) and clinical outcomes (physical function,     anxiety, pain, satisfaction with education, and health related quality of life) will be     assessed among Vancouver-dwelling older adults aged > 50 years, with advanced hip     osteoarthritis. The findings will lead to the refinement of the design protocol in order to     evaluate a contemporary, standardized, and geographically accessible prehab education program     in a large multi-site RCT.   "
24154|NCT02969499|"     This is a prospective, open-label, observational study of the efficacy and safety of ECT for     BPSD. There is no control or comparison group. Subjects will be compared on outcome measures     pre- and post-ECT (and/or with a repeated measures design). Target sample size is 30 subjects     over three years   "
24155|NCT02969486|"     Pulmonary hypertension (PH) is a condition characterized by a sustained elevation in     pulmonary artery pressure (PAP) above 25 mmHg assessed by right heart catheterization. PH is     fatal in absence of adequate treatment or therapy, as the condition progressively increases     the workload of the right heart and ultimately leads to its failure. With a minimal     indicative prevalence of 1 case/300, PH affects at least 25'000 people in Switzerland alone.     After initiation of PH therapy, the follow-up of the patient's health status is often limited     to punctual PAP measurements at the clinic at intervals of several months. The lack of more     frequent measurements of the patient's PAP strongly hinders the identification of short-term     trends in pulmonary hemodynamics, and therefore the anticipation of worsening conditions or     treatment inefficiency. As possible solutions, wireless implantable hemodynamic monitors such     as the CardioMEMSTM HF System (CardioMEMS Inc., Atlanta, USA) have recently been introduced     for the continuous monitoring of PAP in patients with PH. The benefits of frequent     measurements over intermittent clinic visits have been demonstrated in several previous     studies, notably in terms of prediction of therapy outcomes, anticipation of worsening heart     failure, feedback rapidity during therapy, or decline in hospitalization rates. Nevertheless,     despite the undeniable advantages that implantable monitors offer to the patient, they remain     highly invasive solutions. In contrast, noninvasive alternatives for the measurement of PAP     exist, such as transthoracic echocardiography, but are impractical for frequent PAP     assessments due to their dependency on qualified personnel to perform the measurement. An     optimal PAP monitoring modality for patients with PH should be non-invasive (free of any     risks or complications associated with cardiac catheterization) and unsupervised (able to     operate without supervision of a medical doctor). Such a modality does not currently exist.     In the present study, the investigators propose and investigate the potential of a novel     non-invasive, continuous and unsupervised PAP monitoring approach based on the pulse wave     velocity (PWV) principle and the use of electrical impedance tomography (EIT).   "
24156|NCT02969473|"     In this phase II study, the investigators aim to evaluated the efficacy and toxicity of     definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen)     versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell     carcinoma (ESCC).   "
24159|NCT02969434|"     Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue     pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy,     improve both sleep quality and also pain management, and reduce interference of pain with     daily activities. As effective pain relief decreases sleep disturbances, improvement in sleep     has been proposed as marker of effective pain management. Hence it is useful to evaluate     sleep disturbances in chronic pain population both in clinical and research setting. There     are many tools to evaluate sleep quality; the routinely used simple brief pain inventory     (BPI) has a single question about sleep. We will compare three dedicated sleep measures to     the BPI in patients with chronic pain.   "
24160|NCT02969421|"     Randomized controlled trial that compares methods of tenaculum placement during intrauterine     device insertion and their effect on pain. The two methods being compared are slow tenaculum     placement versus tenaculum placement at time of cough. Subjects will be asked to rate their     pain using visual analog scale. Primary outcome measured is pain at time of tenaculum     placement. Secondary outcomes are overall pain with intrauterine device insertion and     provider satisfaction with tenaculum placement.   "
24161|NCT02969408|"     This is a 12-week, multicenter, open-label study to evaluate the relationship between ABS     eMDPI and clinical asthma exacerbation (CAE) in adult patients at least 18 years of age with     exacerbation-prone asthma. The ABS eMDPI dose will be 90 mcg, 1 to 2 inhalations every 4     hours as needed, but patient dosing will not be limited to this dosing regimen. The purpose     of this study is to evaluate the relationship between albuterol dosing and CAE.   "
24162|NCT02969395|"     The purpose of this study is to evaluate product performance of Magnetic Resonance (MR)     Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI     exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT)     measurements following 3T MRI scan exposure. This study is required by FDA as a condition of     approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted     within Medtronic's post-market surveillance platform, the Product Surveillance Registry     (PSR).   "
24163|NCT02969382|"     A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely     psychotic adults with schizophrenia   "
24164|NCT02969369|"     A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's     Disease Psychosis   "
24165|NCT02969356|"     The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®)     injections in upper and lower limbs accompanied with a personal exercise plan called Guided     Self-rehabilitation Contract (GSC) can improve voluntary movements in subjects with     hemiparesis.   "
24166|NCT02969343|"     The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on     developing health information technology (HIT) tools to engage patients, family, and     professional care team members in reliable identification, assessment, and reduction of     patient safety threats in real-time, before they manifest in actual harm.   "
24167|NCT02969330|"     The aims of this study are twofold: (1) to develop an innovative approach for studying brain     glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans;     (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on     brain and brain-stem targets, associated with control of food intake and energy expenditure,     in response to glucose stimuli, in healthy volunteers.   "
24168|NCT02969317|"     The primary objective of this study is to assess the pharmacokinetics of tiotropium +     olodaterol FDC (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after single dose and at steady     state in Chinese patients with COPD.      The secondary objective is to assess the safety of tiotropium + olodaterol FDC (5 μg/ 5 μg)     delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Chinese patients with     COPD.   "
24169|NCT02969304|"     The primary objective of this study is to estimate the proportion of DMF use that is     prescribed on-label versus off-label. The secondary objectives are: To describe the     demographic characteristics and medical history of DMF users; To describe prescription drug     history and concomitant medication use of DMF users; To describe the duration of therapy in     participants newly initiating DMF treatment; To describe the medical specialties of DMF     prescribers.   "
24170|NCT02969291|"     There is a well-documented association between physical activity & risk for breast cancer     development and recurrence. It is known that exercise interventions have been effective at     increasing physical activity levels in breast cancer survivors. Knowing that breast cancer     survivors are less active than non-cancer patients, a less active lifestyle places them at     risk of obesity and poor overall health, which in turn also increases risk of cancer and     cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known     that hormones and other inflammatory markers play a role.      This study has three goals:        1. To investigate the feasibility of a home intervention designed to reduce sedentary          behavior.        2. Describe the effects of the intervention on levels of sedentary behavior, physical          activity, and symptoms.        3. Assess cost of the intervention.   "
24171|NCT02969278|"     The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive     vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.   "
24172|NCT02969265|"     The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan     cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild     to moderate hypertension who do not reach target blood pressure following 4 weeks of     treatment with amlodipine monotherapy.   "
24195|NCT02968966|"     Genetic epileptic encephalopathies (EEs) are a group of very rare and severe,     pharmaco-resistant epilepsy forms characterized by an early onset, e.g. first years of life,     and an often severe developmental delay. Genetic defects were found in different ion channels     such as potassium or sodium channels explaining well the pathological neuronal     hyperexcitability leading to seizures. Further mutations were also found in proteins relevant     for cell structure, DNA/RNA processing or the synaptic vesicular metabolism. Specific and     individualized therapies have not been established neither in the clinical routine nor in     controlled studies. The goal of this monocentric non-blinded non-placebo controlled phase IIb     study is the evaluation of the effectivity of anticonvulsive drugs specifically working on     the ion channels defective in some subtypes of EEs in order to establish a standard and     individualized therapy for these rare diseases based on the specific genetic defect.   "
24175|NCT02969226|"     Background: The sickest patients who are admitted to an intensive care unit (ICU) often     require assistance with their breathing. When patients start to get better, they gradually do     more of the breathing and the machine does less—this is called weaning. Although ventilator     use saves lives, the longer it is used, the more complications can occur. Clinicians aim to     wean patients from ventilators in a timely and safe manner. In most ICUs, patients are     screened (looked at) once per day to see if they are ready to undergo a weaning test (using a     variety of techniques) to see if the breathing tube can be removed. Screening more than once     per day may allow more weaning tests to be conducted. Knowing the best way to do a weaning     test is important because some methods may better determine who can have the breathing tube     removed safely. At present, we don't know the best way to help our sickest patients to wean     from ventilators.      Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who     can take breaths on their own.      Interventions: Patients in our study will receive one type of screening and one type of     weaning test at random. In the 'once daily' screening groups, clinicians will screen patients     each morning. In the 'two or more times daily screening' groups, patients will be screened in     the morning, afternoon, and whenever else clinicians wish to screen. When screening criteria     are met, patients will undergo one of two weaning tests with low ventilator support or no     support.      Outcomes: The main outcome of this study will be the time for patients to be successfully     removed from the ventilator.      Relevance: For patients, this study will clarify the best way to remove them from ventilators     in a timely and safe manner. For clinicians and our health care systems, this study holds     promise to improve how critically ill patients are weaned from breathing machines.   "
24176|NCT02969213|"     The purpose of this study is to develop the electronic management platform for children with     epilepsy, establish large data of Chinese children with epilepsy and explore its biological     etiology.   "
24177|NCT02969200|"     The aim of this study was to investigate renal function decline by measured glomerular     filtration rate (mGFR) in patients with FD during enzyme replacement therapy, and to explore     the influence of age on renal function in FD.   "
24178|NCT02969187|"     Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain     management, efforts are continuing to find effective methods to relieve pain after abdominal     surgery. Although opioid is an effective analgesic it has opioid related adverse events     (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration     of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for     longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively;     results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block     is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce     opioid use and control pain in several laparoscopic surgical procedures, including colorectal     resections, cholecystectomy and bariatric surgery. The aim of this study is to study the     opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using     Exparel versus Bupivacaine as TAP block and port sites infiltration.   "
24179|NCT02969174|"     To establish a genotyping and extraction technology of non invasive prenatal diagnosis for     fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.      To achieve prenatal accurate identification of fetal blood group genotypes，and provide     credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease     of newborn (HDN).   "
24180|NCT02969161|"     This study is to understand how to improve retention in care and treatment services to HIV     positive pregnant women and their babies in Swaziland. The investigators will evaluate     outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of     mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate     lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to     understand the outcomes of patients who are LTF from care, and the reasons for disengagement     from care in the context of PMTCT in order to inform efforts to improve retention in care     among patients under Option B+.   "
24181|NCT02969148|"     To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2     lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced     gastric cancer by prospective randomized controlled clinical trial.   "
24182|NCT02969135|"     Shoulder disorders are extremely common, with a life-time prevalence in population of 30%.     About 23% of the working population with shoulder problems are sick-listed. Specifically     rotator cuff tears are considered some of the principal causes of chronic shoulder pain and     disability, especially with advancing age. The National Patient Register in Denmark has     registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.      A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most     frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of     function due to pain and tissue weakness. Little is known about the effects of the     postoperative training/rehabilitation, and this provides an unclear picture of the total     treatment procedure of this condition.      The Danish National Clinical Guidelines from 2013 recommend that these patients are offered     rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for     postoperative training is moderate- low. The past few years, there have been conducted 5     systematic reviews looking at different rehabilitation parameters after rotator cuff surgery.     They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do     not increase risk of re-rupture and that immobilization do not increase tendon healing or     clinical outcome. They also conclude that there is a further need to evaluate approaches that     foster early initiation of rehabilitation and gradual introduction of functional load in     high-quality, adequately powered trials, also considering key outcomes such as return to     work.      Therefore, the aim of this study is to compare the effect of a progressive early passive and     active movement protocol with a care as usual (limited early passive movement protocol) on     tendon healing, physical function, pain, and quality of life, in patients operated due to     traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.      Shortterm effects of physical function, pain, and quality of life will be studied as primary     patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes     in addition to the longterm effects of physical function, pain, and quality of life.   "
24183|NCT02969122|"     Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging     system. Controversy exists on the treatment of this part of patients. This trial aimed to     explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal     cytology as the only non-curable factor.   "
24184|NCT02969109|"     A study to validate, in a prospective manner, the ability of the predefined Genomic Health     bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle     invasive bladder cancer.   "
24185|NCT02969096|"     The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation     therapy for hepatic carcinoma.   "
24186|NCT02969083|"     The aim of this study is to explore feasibility of Upper Tract Urothelial Carcinoma (UTUC)     treatments based in real world data in various European countries. The study will allow to     gain insight in the true proportion of patients that fit to receive complete cisplatin-based     neo-adjuvant or adjuvant chemotherapy, and the proportion and clinical outcome of patients     with poor prognostic factors (PS and renal function) who receive only standard treatment     (Radical nephroureterectomy (RNU)). This comparison will be made using a uniform diagnostic     and treatment protocol.   "
24435|NCT02965820|"     The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to     non-HYDRAGLYDE® multipurpose contact lens solutions in presbyopes currently wearing soft     contact lenses and experiencing symptoms of dryness.   "
24187|NCT02969070|"     Hypercholesterolemia is considered one of the most important cardiovascular risk factors.     Cardiovascular prevention include a class I indication to statins in addition to     non-pharmacologic intervention and prevention strategies in patients deemed to be 'high     risk'. Along with non-pharmacologic intervention and prevention strategies, newer approaches     to reduce cholesterol blood levels currently include nutraceuticals, which are compounds     derived from foods with cholesterol lowering actions. However, it remains unclear if     nutraceuticals yield additive positive effects other than cholesterol lowering. In     particular, there is evidence that Berberine has cardiovascular protective effects and that,     in vitro, Morus Alba, mulberry fruit, modulates platelet function by inhibiting platelet     activation, thromboxane formation, serotonin secretion, aggregation and thrombus formation.     Furthermore, Morus Alba exerts an α-glucosidase inhibitory and antioxidant activity in vitro,     which may reduce postprandial glucose peak, thus improving HbA1c concentration. Accordingly,     we designated a study to evaluate the effects of two commercially available nutraceutical     combined pills [LopiGLIK™, Akademy Pharma, 1 capsule/day containing red yeast rice 220 mg (at     least 3,3 mg of Monacolin K) + Berberine 531,25 mg + Morus Alba 200 mg (at least 4 mg of     Deoxynojirimycin) vs. Armolipid Plus®, Meda Pharma, 1 capsule/day containing Berberis     aristata d.e. 588 mg (equivalent to Berberine chloride 500 mg) + Red yeast rice 200 mg     (equivalent to Monacolin K 3 mg) + Policosanol 10 mg + Folic acid 0.2 mg + Coenzyme Q10 2.0     mg + Astaxanthin 0.5 mg] on lipid and metabolic profile, platelet aggregation, endothelial     function and coronary flow reserve (CFR). For this purpose patients with hypercholesterolemia     not requiring statins or statin intolerant at moderate cardiovascular risk will be subjected     at day 0 and at day 28, after 4 weeks of therapy, to blood sampling to evaluate lipid and     metabolic profile, peripheral arterial tonometry (EndoPAT), platelet aggregation tests with     light transmission aggregometry (LTA), nitric oxide (NO) release, endothelial nitric oxide     synthase (eNOS) phosphorylation on platelets. Only for CFR, patients will be further     evaluated also after two hours from the administration of the first dose of nutraceutical     combined pill. Patients will be randomly assigned to receive therapy with LopiGLIK™ or with     Armolipid Plus®.   "
24188|NCT02969057|"     The objective of the present study is to compare the effects of liquid or solid state of food     on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years will be     recruited from the general public in Singapore. Fingerpricks and cannulation may cause minor     discomfort and there may be some slight bruising around the site. Fingerpricks and     cannulation will be done by an experienced research nurse or a trained research officer to     minimize participant discomfort. If bruising does occur, it should disappear within one day     and it should not affect participants' regular daily activity. Participants will be limited     to a maximum of one test per week. In addition, blood collection will be carried out in a     sterile designated area and thus the risk of infection will be very low. On rare occasions,     participants may feel unwell during or after the testing session. We have several metabolic     suites with beds for these individuals to rest on. The research nurse and research officers     will monitor the individuals' condition and they will be provided with a ride home if     required. All the study foods will be prepared in a hygienic manner in a purpose-built     research kitchen maintained to the highest hygiene standards. The research staff has     undergone basic training in food hygiene procedures. Hence, the risk of infective acute     gastroenteritis will be minimal. Participants will be provided with some snacks at the end of     each testing session. They will also be reimbursed to compensate for their time and costs     associated with travel and parking at the completion of the study. In addition, participants     will be provided with their blood glucose, blood pressure, and body composition results, with     a brief interpretation of these at the conclusion of the study.   "
24189|NCT02969044|"     This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in     seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate     (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF     biologic).   "
24190|NCT02969031|"     The overarching goal of this project is to improve communication between oncologists and     their patients by ensuring that the patient's voice is heard in the medical encounter. Thus,     the hope is to improve the experience for patients living with cancer. The investigators seek     to accomplish this goal by providing oncologists communication skills training that includes     feedback on their own audio-recorded conversations. The feedback will come from two sources:     1) Professional research assistant coders who will identify objective learning opportunities     based on specific coding criteria and 2) Trained patient reviewers who will listen to the     recordings and offer their own, subjective feedback at key moments in the encounters.   "
24191|NCT02969018|"     The purpose of this study is to determine whether PF-06700841 is safe and effective in the     treatment of chronic plaque psoriasis.   "
24192|NCT02969005|"     Localization of small femur lesions for resection can be challenging and may be associated     with the need for significant fluoroscopic imaging and tissue dissection.   "
24193|NCT02968992|"     The purpose of this study is to investigate how recombinant human lactoferrin (rhLF) which is     a partially iron saturated form of lactoferrin produced and purified from rice grain may     improve mobility and memory in older adults with chronic inflammation. Lactoferrin, is a     known multifunctional protein, and has been shown to have anti-inflammatory effects. A     recombinant human version of this protein was recently developed and produced from rice. This     is now available from the Ventria Bioscience Company in a controlled, pharmaceutical grade     capsule. As part of this double blinded and randomized study, participants will take daily     dosages of recombinant human lactoferrin (rhLF) or its matched placebo; to measure the     effects of rhlactoferrin on chronic inflammation and its association with improving mobility     and memory over a 6 month time period. During the study all participants will be asked to     provide blood samples and will have physical and cognitive tests administered to them. By     measuring biomarkers in the blood as well as changes in physical and cognitive measures, the     investigators will gain an understanding of how rhlactoferrin may safely improve measures of     chronic inflammation in older adults. As well as a better understanding of whether it has the     potential to meaningfully influence important measures of physical and cognitive function     known to be influenced by Chronic Inflammation (CI).   "
24194|NCT02968979|"     The purpose of this study is to assess the frequency of cachexia and the management of     cachexia and associated symptoms in a patient population with non-small cell lung cancer     (NSCLC).   "
24212|NCT02968745|"     Aim: To identify the main occupational performance problems reported by individuals with     rheumatoid arthritis and the relationship between these activities with work status of     participants . Methods: the investigators conducted a cross-sectional study with 81 patients     with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was     described in frequencies and percentages, and the Pearson's chi-square test was used to     determine the asymptotic association between the occupational performance problems with work.   "
32731|NCT02857335|"     15 patients, Ages 8-17 who were diagnosed in the recent years with Idiopathic increased     intracarnial hypertension (IIH) went through a battery of neurocognitive tests to establish     whether there was any affect of the disease on their cognitive function   "
24203|NCT02968862|"     The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery     involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post     surgical hospital stay of one to three days. These patients will be randomly assigned by the     BWH Investigational Drug Service to one of three different groups, each consisting of 33     patients:      • Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine     6.25 mg for a total volume of 10 ml.        -  Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a          total volume of 10ml.        -  Group 3 patients will receive 10 ml of preservative free saline and this will serve as          the control group.   "
24204|NCT02968849|"     This study will evaluate the preventive vaccine efficacy, safety, and tolerability of     ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults     over 24 months and potentially up to 36 months from enrollment.   "
24205|NCT02968836|"     Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality     in Intensive Care Unit (ICU) patients.   "
24206|NCT02968823|"     Our primary aim is to determine whether licorice gargling provides meaningful analgesia after     oral surgery. Specifically, we propose to test the primary hypothesis that gargling with     licorice solution reduces pain after oral surgery more than gargling with sugar water.     Because effective analgesia can reduce pain and/or opioid consumption, we will jointly     evaluate verbal response pain scores and overall morphine consumption considering licorice to     be beneficial only if it proves non-inferior on both measures and superior on at least one.   "
24207|NCT02968810|"     This randomized phase II trial studies how well simvastatin works in preventing liver cancer     in patients with liver cirrhosis. Simvastatin may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.   "
24208|NCT02968797|"     SafeSed prototype monitors respiratory parameters by tracking chest movements with optical     and accelerometer markers. The respiratory parameters are compared to respiratory parameters     measured by a spirometer and a capnograph.   "
24209|NCT02968784|"     This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can     significantly postpone or eliminate the need of patients with organ confined intermediate     risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or     Radiation therapy) for their disease.   "
24210|NCT02968771|"     The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in     order to detect differences based on the type of stress (physical or pharmacological with     adenosine agonists) and result of test (positive or negative for ischemia) and to indentify     biochemical markers with prognostic value. Clinical data of enrolled patients regarding     demographics, cardiovascular risk factors, pretest probability and previous cardiovascular     disease will be recorded. Follow up will be at one, three and five years and will be     performed by clinical recordings or phone call when necessary. Blood samples of patients     undergoing myocardial perfusion SPECT (Single Photon Emission Computed Tomography) are taken     before, immediately after stress and 2h after stress. Serum samples will be analyzed by     nuclear magnetic resonance in order to know metabolomic profile.   "
24211|NCT02968758|"     The primary purpose of this clinical investigation is to verify the performance of the     GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC     CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a     conventional method considered as gold standard for detection of toxigenic Clostridium     difficile in stool specimens.   "
24213|NCT02968732|"     A prospective, investigational study to assess the accuracy of standardized cystoscopic     evaluation with tissue sampling performed immediately prior to definitive radical cystectomy     to predict pathologic tumor stage and identify patients who may benefit from bladder     preservation therapy.   "
24216|NCT02968693|"     Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of     the lower extremities were included in the retrospective investigation. The patients were     assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate     and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological     parameters, eradication of infection, rate of infection recurrence and reoperation rate were     evaluated during the follow-up.   "
24217|NCT02968680|"     This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting     sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that     may make it easier to see if the tumor cells have spread to the sentinel lymph node using an     ultrasound.   "
24218|NCT02968667|"     A randomized controlled trial was conducted from November 2015 and May 2016 with 112     participants of people diagnosed with schizophrenia. Participants aged 18 years or older with     Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from     outpatient mental health clinics in Jordan, were randomly assigned participants either to     receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment     as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed     at baseline, immediately post-intervention (post-treatment1) and at three months follow-up.     The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS     were psychiatric symptoms, recovery rate and quality of life.   "
24219|NCT02968654|"     To compare a liberal and a restrictive strategy to administer blood transfusions in     critically ill patients with a primary brain injury.   "
24220|NCT02968641|"     A Phase 2b, Open-Label, Randomized Study of the Safety, Tolerability, and Pharmacodynamic     Activity of Lonafarnib With or Without Ritonavir in Patients Chronically Infected with     Hepatitis Delta Virus   "
24232|NCT02968485|"     This aim of study to assess the safety and tolerability of SHR7390 and to define the maximum     tolerated dose (MTD) of SHR7390 in the patients with advanced solid tumors.      To evaluate the pharmacokinetics of SHR7390 in patients with advanced solid tumors.      To study the effects of food on the pharmacokinetic parameters of SHR7390. To assess the     antitumor activity of SHR7390 in patients with advanced solid tumors preliminarily and     recommend reasonable dosage regimen for the follow-up clinical trial.   "
24404|NCT02966236|"     This study is a double blinded randomized controlled trial evaluating the impact of     tranexamic acid use on the transfusion rate in patients with complex kidney stones undergoing     percutaneous nephrolithotomy.   "
24221|NCT02968628|"     Alterations in the intrauterine environment can have profound effects on fetal development.     Diabetes during gestation results in multiple deleterious short-term outcome differences, and     is correlated with long-term developmental deficits. Multiple studies, in neonates through     school-aged children, have demonstrated differences in language, attention and psychomotor     development in offspring of diabetic pregnancies. Neonatal EEG is a promising and     non-invasive tool for assessment of abnormal brain development or dysmaturity in this     population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters     change predictably with advancing gestational development and have been used to differentiate     between at risk groups in neonatal studies.      The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of     diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is     documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of     aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain     development.      The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to     gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation     whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video     EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and     5 days of life during birth hospitalization. Additional data will be extracted from maternal     and neonatal medical records and a maternal questionnaire.      In addition to evaluating the measures of cEEG and aEEG, this project will establish a     research cohort. A subsequent study involving developmental evaluations will allow for     correlation of EEG results with long-term outcomes. The ability to identify those at risk at     birth would provide the opportunity to intervene in order to mitigate outcome differences,     particularly in language development. More significantly, we hope to establish neonatal CNS     outcome measures for future diabetic pregnancy intervention studies. .   "
24222|NCT02968615|"     The investigators examined feasibility and acceptability of a non-restrictive diet focused on     increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a     12-week assessment which included 6 bi-weekly individual dietary counseling sessions to     attain a daily goal of higher fiber (>35 g/day) and lean protein (0.8 g per kilogram/day of     individual's ideal body weight).   "
24223|NCT02968602|"     Craving for cigarettes is an important aspect that leads to challenges with smoking     cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than     persons without schizophrenia, and may experience craving differently as well. Minocycline is     an antibiotic medication that may impact craving. We will conduct a two-week randomized,     double-blind, placebo-controlled, parallel group pilot study to investigate the effects of     minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia.     Participants will take minocycline or matching placebo for two weeks. Participants will be     assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of     minocycline or placebo treatment.   "
24224|NCT02968589|"     The purpose of this study is to determine if the @ctivehip tele-rehabilitation system     improves the functional level and quality of life of hip fracture patients and reduce the     caregiver burden.   "
24225|NCT02968576|"     Poor adherence to tenofovir (TDF) and emtricitabine (FTC) for Human Immunodeficiency Virus     (HIV) pre-exposure prophylaxis (PrEP) is common and the leading cause of therapeutic failure.     The investigators need better ways to measure adherence in patients on PrEP. This application     will address the need to measure adherence by evaluating an integrated technology system,     Proteus Discover, when combined with Truvada. The Proteus Sensor System (PSS) will confirm     that Truvada was taken, monitor adherence in both recent and long term dosing, and provides     feedback to encourage adherence. The goal of this study is to determine whether the use of     the PSS with Truvada will vary the drug concentrations of FTC/TDF. Participants will have 2     study visits where they will be randomized to either start with the combined PSS with Truvada     or just Truvada alone. Study participants will come to the Clinical & Translational Research     Center (CTRC) in the morning and take the assigned dose and will then have blood drawn at     about .25, 0.5, 1, 2, 4, 6, and 10 hours after medication is taken. Participants will then     return to the CTRC for blood draws 24, 48, and 72 hours after they took the dose on the first     day. The second visit will mimic the first except that the participant will take the other     dose form.   "
24226|NCT02968563|"     The objective of this study is to determine the preliminary efficacy and safety of the     combination of tirabrutinib (GS-4059) and idelalisib with and without obinutuzumab in adults     with relapsed or refractory chronic lymphocytic leukemia (CLL).      The study has a 6 patient per arm safety run-in to evaluate safety prior to the enrollment of     subsequent participants. The primary objective is evaluation of efficacy with the secondary     objective evaluation of safety and evaluation of additional parameters of efficacy. The     treatment period is adaptive, with a duration of active treatment up to two years and a total     follow-up on study of 5 years for time-dependent outcome variables.   "
24227|NCT02968550|"     . The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress     during one lung ventilation (OLV) at different levels of positive end expiratory pressure     (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during     OLV.   "
24229|NCT02968524|"     This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based,     temperature indicator in estimating the body temperature of Nigerian babies exposed to     ambient temperature conditions. The particpants will be recruited among babies receiving     Filtered Sunlight Phototherapy (FSPT) at Bowen University Teaching Hospital, Ogbomoso and     other babies in the nursery at Bowen University Teaching Hospital.      There will also be an educational session to teach health workers and mothers about the signs     for hypothermia and hyperthermia on the indicator. Then, the investigators will collect     observational cross-sectional data on random days to see how many of the trained health     workers and mothers were able to accurately recognize and provide appropriate response to     warning signs on the indicator.   "
24230|NCT02968511|"     The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate     the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.     difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota     transplant (FMT) can improve scCDI, with improve defined as either decreasing the severity     of CDI, or by resolving the infection altogether. Third, the study seeks to further study the     mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing     on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and     fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred     to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy     donors.      The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared     to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.   "
24231|NCT02968498|"     Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in     each study part.      The objective of the study is to investigate blood glucose levels after oral intake of     defined amounts of lactulose.   "
24233|NCT02968472|"     A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19     (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells     tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change     process of the CART and residual tumor status of the patient are observe dynamically， which     summarizes the best therapeutic effect.   "
24234|NCT02968459|"     This is a single center, randomized, double blind, placebo controlled study to evaluate the     safety and efficacy of umbilical cord mesenchyme stem cell local intramuscular injection for     treatment of caesarean section uterine scars.   "
24235|NCT02968446|"     The purpose of this research study is to evaluate the effects of an oral Vitamin D on the     body's immune system.      An interest has been growing because studies have shown that Vitamin D may reduce     inflammation and harmful effects in the body, however, the best dose for Vitamin D is still     unknown.      Inflammation is the body's physical response to infection, injury, or long term disease.     Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the     body. This study will look at product use, testing skin irritation in healthy volunteers and     seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could     one day help doctors prescribe Vitamin D to patients with long term disease to relieve their     symptoms.   "
24236|NCT02968433|"     The purpose of this study is to demonstrate that young plasma infusions can be performed     safely in patients with Parkinson's Disease (PD). Secondary outcomes will include behavioral     and laboratory data that will support the next study that will inquire whether young plasma     infusions improve or slow the progression of cognitive, mood and/or motor impairment and rate     markers of the disease.   "
24237|NCT02968420|"     The overall aim of this study is to further understand the memory response to HPV vaccination     in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory     responses can be detected shortly after immunization, the best approach to measure the     long-lasting anamnestic response is to challenge with a booster dose years (> 5) after the     original exposure.   "
24238|NCT02968407|"     The study group want to investigate whether doctors, who are in the beginning of their     training to become surgeons, can rate themself and their peers using Objective Structured     Assessment of Technical Skills. Participants have participated in a 6 weeks course in basic     open surgical skills. At the end of the course the participants will be examined at at     videotaped test. The participants will be asked to rate their own video and two videos of     other trainees' performances. Ratings will be compared to expert ratings.   "
24239|NCT02968394|"     The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction     of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to     systemic reactions.   "
24240|NCT02968381|"     Tobacco use is still the leading cause of preventable disease and death in the United States.     Tobacco quit lines are effective at helping smokers to quit, but quit lines are     underutilized, especially by men and racial/ethnic minorities. Guided imagery is effective at     helping people quit smoking, and is appealing to males and diverse racial groups, but has     limited reach. The proposed study will develop and test the feasibility and acceptability of     a guided imagery tobacco cessation intervention that is delivered by a combination of quit     line coaches and an interactive website. The investigators hypothesize that guided mental     imagery delivered using the quit line coaching model combined with an interactive website     could be an effective intervention strategy.   "
24241|NCT02968368|"     To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA     in subjects with CKD   "
24242|NCT02968355|"     This study will evaluate the clinical sensitivity and specificity of the FilmArray Global     Fever (GF) Panel.   "
24243|NCT02968342|"     The objective of this study is the role of vaginal progesterone gel in the treatment of     menopausal hypoactive sexual desire disorder. Half of the study participants will receive a     standard dose of self applied vaginal progesterone gel and the other half will receive oral     vitamin tablets.   "
24244|NCT02968329|"     Stroke is an important cause of disability and the third leading cause of death.      Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be     found). There have been few previous studies regarding risk stratification for stroke     recurrence in patients with cryptogenic stroke.      Recent studies have suggested that left atrial (LA) function is an important determinant of     stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to     investigate other echocardiographic parameters. The aim of this study is to assess the     predictive value of left atrial function for the risk of stroke recurrence and/or atrial     fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven     atrial fibrillation (AF) and no indication for anticoagulants.   "
24245|NCT02968316|"     This is a prospective observational study correlating Body Impedance Analysis (BIA) with     pregnancy outcomes.   "
24246|NCT02968303|"     Rationale:      The combination of ipilimumab and nivolumab induces relatively high response rates and     promising response depth in late stage melanoma. Nevertheless, it takes time till responses     occur and still a significant number of patients do not benefit from treatment, due to rapid     progressive disease or resistance to therapy.      In contrast to immunotherapies targeted therapies (BRAF or MEK inhibitors), can induce faster     and higher response rates, but often of shorter duration, even when combined.      Initial attempts of combining vemurafenib or dabrafenib + trametinib with ipilimumab failed     due to toxicity.      Patients with elevated levels of serum LDH are less likely to respond to immunotherapy     compared to patients with normal LDH levels. This does not mean that such patients do not     benefit at all from immunotherapy.      This raises the question, whether response rates upon immunotherapy can be improved by     upfront reduction of tumor burden and normalization of LDH.      The investigators postulate that induction therapy with combined BRAF+MEK inhibition, and     subsequent LDH normalization, can improve response rates to the rates seen in LDH normal     patients.      To address this question the investigators have setup a randomized phase 2 trial in     metastatic melanoma patients with elevated serum LDH comparing the response rates upon     ipilimumab + nivolumab versus ipilimumab + nivolumab preceded by 6 weeks of vemurafenib +     cobimetinib induction.      Furthermore, less than half of the patients treated with the combination of ipilimumab and     nivolumab received maintenance nivolumab, and approximately 40% of all patients discontinued     treatment for toxicity. In 70% of patients responses were ongoing despite discontinuation of     treatment due to toxicity. This raises the question, to what extent does maintenance therapy     add clinical benefit to an ongoing immune response. Preclinical data indicate even that     continuous restimulation of T cells can result in activation induced non-responsiveness     (anergy).      Therefore, a secondary objective of this trial will be, to test a response-driven nivolumab     scheme      Objectives:      Primary Objective • To compare efficacy of induction vemurafenib + cobimetinib followed by     ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).      Secondary Objectives        -  To describe duration of response and overall survival induced by vemurafenib +          cobimetinib followed by the combination of ipilimumab + nivolumab (Arm A) as compared to          ipilimumab + nivolumab (Arm B)        -  To describe the rate and quality of toxicity observed in the two study arms        -  To describe the rate of ongoing responses upon response-driven flat dose (240mg, q2w)          nivolumab maintenance        -  To determine the immune-activating capacity of induction therapy with vemurafenib +          cobimetinib followed by the combination of ipilimumab + nivolumab.        -  To evaluate the changes in systemic immune competence      Study design:      This is a two-arm phase 2 study consisting of 200 BRAFV600E/K mutation-positive late-stage     melanoma patients with an elevated baseline LDH level (> ULN, < 3xULN) randomized 1:1     (stratified according to LDH) to receive either vemurafenib + cobimetinib directly followed     by ipilimumab + nivolumab (Arm A) or standard first line ipilimumab + nivolumab (Arm B).     Subsequently, patients in both arms will receive flat dose (240mg, q2w) nivolumab maintenance     in a response-driven manner.      Study population:      Stage IV, or unresectable stage III, BRAFV600E/K mutation positive melanoma patients, naïve     for BRAF/MEK, PD-1/PD-L1 or CTLA-4 targeting therapy, 18 years and older.      Intervention:      Patients will be randomized 1:1 to receive either 6 weeks vemurafenib 960 mg bid +     cobimetinib 60 mg QD 21-day on, 7-day off (21/7) schedule, directly followed by 4 courses of     ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm A) or first line standard 4 courses of     ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm B).      Subsequently, patients in both arms will receive nivolumab maintenance flat dose (240mg, q2w)     in a response-driven manner according to their response at week 18.      Main study parameters/endpoints:      Primary Endpoints      • Compare the best overall response rate (BORR) according to RECIST 1.1 of both arms at week     18 from start of treatment.      Secondary Endpoints        -  Progression-free survival (PFS) according to RECIST 1.1        -  Overall survival (OS)        -  Percentage of grade 3/4 toxicities according to CTCv4.03        -  Percentage of ongoing response, percentage of patients requiring re-induction, response          percentage upon re-induction        -  Changes in tumor-specific T cell responses   "
24247|NCT02968290|"     The purpose of this study is to quantify the opacity of posterior capsule in pediatric     cataract comparing two intraocular lens materials.   "
24248|NCT02968277|"     The purpose of this project is to evaluate if the LifeWalker Upright walker is improves     walking and reports of pain compared to a conventional rollator and predicate walker device.   "
24249|NCT02968264|"     The aim is to conduct a prospective multi-centre international inception cohort study with an     enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample     size and methodology will result in statistically powerful results to allow for     evidence-based change to current TOF surgical practices.   "
24250|NCT02968251|"     The aim of the study is to design and evaluate a school-based hand washing program for     children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT),     so as to improve proper hand washing, increase knowledge level and also reduce school     absenteeism.   "
24269|NCT02968004|"     This will be an open-label, randomized, multicenter, efficacy and safety study of weekly     MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone     deficiency.   "
26509|NCT02938871|"     The purpose of this study is to evaluate the use of synbiotic in patients after liver     transplantation and assess the effect of these agents on postoperative infections, antibiotic     use, length of hospital stay, mortality and nutritional status.   "
24251|NCT02968238|"     Anxiety disorders are the most prevalent psychiatric disorders. Among older adults, anxiety     is more common that depression, yet research on the nature and treatment of anxiety has     lagged far behind that of depression. The investigators' work has demonstrated that CBT is     superior to enhanced usual care as well as supportive therapy in improving worry, depressive     symptoms, and sleep, and these improvements are maintained for up to 1 year upon completing     treatment. Research demonstrates that yoga reduces anxiety symptoms and the investigators'     own work demonstrates that yoga improves sleep. However, no one has conducted a comparative     effectiveness trial of CBT and yoga for treating worry in older adults. In fact, there are     very few comparative effectiveness trials for treating late-life anxiety. Thus, clinicians     are unable to provide an informed recommendation of one treatment over the other. The     investigators propose a two-stage randomized preference trial comparing 1)     cognitive-behavioral therapy with 2) yoga for the treatment of worry in a sample of older     adults. Participants will be randomized to either the preference group (participants choose     the treatment) or to the random group (participants are randomized to 1 of the 2 treatments).     This study design allows for the calculation of traditional treatment effects (differences in     outcomes between participants randomized to either CBT or yoga), selection effects     (differences in outcomes between participants who choose CBT and those who choose yoga), and     preference effects (differences in outcomes between participants who choose their treatment     and those who are randomized to treatment).   "
24252|NCT02968225|"     The investigators hypothesize that this serious game (designed to provide a learning     environment that maximizes opportunities for adolescents with autism to discover the     functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to     identify gazed-at objects, and will also lead to increased social attention to faces in     adolescents with autism. The investigators will test this hypothesis in a small-scale     exploratory randomized control trial that will include both behavioral and eye tracking     outcome measures.   "
24253|NCT02968212|"     The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine     when used to treat Mycobacteria avium complex (MAC) lung disease.      Funding Source - FDA OOPD   "
24254|NCT02968199|"     This study describes the development of a community-based network to promote smoking     cessation among female smokers in Hong Kong.   "
24255|NCT02968186|"     The objective of this study is to investigate the efficacy of an implementation program     specifically designed to increase alcohol screening and brief intervention rates in primary     health care.   "
24256|NCT02968173|"     This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the     safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of     the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants     at high risk (infants born at less than or equal to 35 weeks gestational age and less than or     equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age     with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical     treatment within the previous 6 months or infants less than or equal to 24 months of age with     hemodynamically significant congenital heart disease [CHD]).   "
24257|NCT02968160|"     This is a Randomized, open-label, 2 groups, parallel design.   "
24258|NCT02968147|"     ﻿﻿Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an     irregular heart beat resulting in symptoms including palpitations and breathlessness. It is     known that in most cases, AF is caused by abnormal electrical activity from the top of the     left side of the heart (left atrium) which overrides the heart natural pacemaker in the right     atrium. Treatment options include tablets which suppress this abnormal electrical activity,     but in some patients these are not sufficient and a procedure is carried out where the areas     of abnormal electrical activity are disconnected or 'ablated' to prevent AF from occurring.     This treatment is well established and performed worldwide, often under general anaesthetic     (GA). The heart and lungs sit close together in the chest, and when the lungs are inflated     and deflated during the procedure, the heart also moves. This movement is then transmitted to     the special wires or 'catheters' that are placed inside the heart to deliver the ablation     treatment. Instability during the treatment can result in ineffective areas of ablation which     may later contribute to reduced success of the procedure. Previous research has shown that by     reducing the movement of the heart under anaesthesia using alternative techniques can improve     catheter stability and improve procedural results. Once such technique is called high     frequency jet ventilation (HFJV) which allows the lungs to filled with air using fast and     shallow breaths resulting in normal blood oxygen levels with little movement in the heart.     This technique has been shown to be safe and effective for this procedure but a direct     comparison with conventional ventilation has not been done. The investigators wish to test     this and determine if using HFJV improves outcomes during the procedure (i.e. can     investigators do the treatment faster and more effectively) and if this translates to better     outcomes long term.   "
24259|NCT02968134|"     The purpose of this study is to try to find out how critically ill patients receiving the     anti fungal medication, posaconazole, process it in their body. Investigators would like to     study if the recommended doses of posaconazole achieve adequate concentrations in the     patients blood to treat fungal infections.The disease process in critically ill patients can     profoundly influence the concentration of anti fungal medication in the blood. The process by     which a drug travels through the body in blood, how it is broken down and removed by the body     is called pharmacokinetics (PK).      This information is important to know because if antifungal levels are low in the blood, the     fungal infection has an opportunity to become resistant to the antifungal medication which     can lead to the medication being less effective against the fungal infection potentially     exposing future patients with infection to a limited range of effective antifungals.      Investigators can measure the PK by taking blood samples at specific times after the anti     fungal medication is given.      This study will enroll 8 patients who are admitted to the intensive care unit and are being     treated with an antifungal medication for a fungal infection. Patients will be consented and     given a single dose of posaconazole and serial blood samples will be collected just prior to     the dose and at 15, 45,75 minutes during the infusion and at 3, 5, 8, 12, 18, 24, 30 36 and     48 hours . Information about the patients stay in the ICU will also be collected including     blood pressure, temperature, blood test results.   "
24260|NCT02968121|"     To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered     subcutaneously or intramuscularly in adults with schizophrenia.   "
24415|NCT02966080|"     Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support     called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials     used in ECMO machines may help prevent clots - this could allow the use of lower doses of     heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose     heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting,     but may cause less bleeding and be safer for patients.   "
24261|NCT02968108|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects     from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old     in other countries and determine if it is similar to that observed in adults with moderately     to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and     efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part     of the study continues to Week 16, at which point all subjects who are receiving benefit from     ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the     long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at     Week 236.   "
24262|NCT02968095|"     The purpose of this research is to test a text message intervention for people who are     beginning an attempt to quit smoking. The intervention seeks to teach people to think about     their cravings to smoke in more helpful ways. The investigators expect that participants     receiving the text message craving program will be less likely to begin smoking again     compared to participants in a control condition.   "
24263|NCT02968082|"     A Single-center, randomized, prospective, experimental, double-blind comparison study for     effects of preoperative scopolamine patch application on the postoperative nausea and     vomiting in microvascular decompression surgery   "
24264|NCT02968069|"     Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic     efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community     hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous     lesions.The investigators will conduct a study to develop and validate a diagnostic model     based on NBI for early gastric cancerous lesions under endoscopic observation.   "
24265|NCT02968056|"     There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of     stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and     single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of     thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an     attractive procedure to improve the treatment of persistent AF. However, only a few centers     reported their preliminary results, and the conclusions are controversial. The investigator     previously reported a minimally invasive surgical ablation from left thoracoscope only and     achieved good results. Recently, the investigator successfully explored a hybrid procedure     combing this unique surgical technique and transvenous catheter ablation. Here, the     investigator present a study to evaluate the efficacy and safety of this novel hybrid     procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation     alone in the treatment of persistent AF.      This study is a non-randomized controlled study within a single institution. Isolated     persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua     Hospital will be screened for enrollment of this study. The study will recruit 180 patients     in total. Based on their own willingness, the patients will be divided into hybrid group and     minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery     from left thoracoscope as the investigator reported before, while the hybrid group patients     will have additional transvenous catheter ablation after the surgical ablation is done during     the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each     group contains 90 patients. The perioperative data is collected, and the patients will be     followed for 6 months. The primary outcome is the rate of sinus rhythm at 6 months post     operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative     complications, major cardiovascular events, stroke, left ventricular systolic function,     medical expense, serum brain natriuretic peptide level and quality of life. The aim is to     evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more     evidence of the hybrid strategy in the treatment of persistent AF.   "
24266|NCT02968043|"     Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents.     Exercise is the most common conservative therapy for mild AIS patients. There are increasing     evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the     curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality.     The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle,     fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for     mild AIS patients, and to promote PSSE's application in Shanghai.      Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each     subject will be asked to sign an informed consent form before the subject participate in the     study.      Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the     intervention group, in which they will perform PSSEs; or the control group, in which they     will perform generalised physiotherapy exercises. All subjects will be assessed at the     initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic     appearance, radiographic measurement, static balance test, pulmonary function test, bone     quality, and HRQoL will be used.   "
24280|NCT02967861|"     The objective of the study was to evaluate the levels of Peroxisome proliferator-activated     receptor gamma (PPAR-γ), Nuclear factor-kappa B (NF-kB) and the presence of red complex     microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and     Tannerella forsythia (T.f) in the subgingival tissues of chronic periodontitis subjects     before and after intervention with pranayama as an adjunct to scaling and root planing.   "
24281|NCT02967848|"     This is a Phase 1 pilot study to assess feasibility and utility of 99mTc-mebrofenin     hepatobiliary scintigraphy for measurement of functional liver change due to radiotherapy.   "
24282|NCT02967835|"     Will Tele-psychiatry be effective and acceptable to patients.   "
24267|NCT02968030|"     Aging is characterized by functional losses among which, the related to mobility and balance     may be highlighted. Regular physical activity, including muscle strengthening exercises, is     beneficial to a healthy elderly. Thus, this study aimed to verify the influence of 8     weeks-program of lower limbs strengthening exercises in the balance and functional mobility     of physically active elderly. The investigators evaluated 18 women, with ages between 61 and     80 years. Balance assessment was performed using the Functional Reach Test (FRT), Timed Up     and Go (TUG) test and Romberg test in stable or unstable soil. For muscular strengthening of     the lower limbs, the workload was determined by the strength reached in the eight-repetition     maximum test (8RM), applying progressive load increments between training sessions conducted     (50% , 60% , 70% of 8RM), with the muscle strength being reevaluated in the fourth week of     training, with subsequent adjustment of the load for the subsequent training. The training     took place in two weekly meetings, in 40-minute sessions, during eight weeks. Data were     analyzed using the paired-t test and ANOVA with repeated measures. Among 18 evaluated elderly     women, 7 completed the 8 week training proposed. Decrease in TUG time (p = 0,035) and     statistically significant increase in muscle strength were observed in all muscle groups     trained (quadriceps, hamstrings, adductors and abductors). FRT (p = 0.170) was not     significantly different after training. Therefore, strength training proposed was efficient     in improving muscle strength in the lower limbs of irregular physically active elderly,     impacting positively on functional gain gait. However, the gain in muscle strength was not     enough to generate significant results in static balance probably due to the type of exercise     performed as well as due being limited to muscle groups of the lower limbs.   "
24268|NCT02968017|"     Doppler measurements in the Middle Cerebral Artery (MCA) is a part of the assessment for     assessing fetal well-being in complicated pregnancy, including Intra Uterine Growth     Retardation and Fetal Anemia.      The use of this Doppler measurement in uncomplicated term pregnancies is not a common     practice due to lack of information. However, several studies use the MCA Pulsatility Index     (PI) as part of the Cerebro-Placental-Ratio (CPR) measurment at term.      The purpose of this trial is to assess MCA Doppler variability in term, uncomplicated     pregnancy.   "
24270|NCT02967991|"     Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in     the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy     remains an important method for helping to determine the etiology and stage of LD.     Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy     (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic     ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective     method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well     as the adequacy of specimens obtained in this fashion. Most studies involve a 19-gauge     needle, therefore in this study the investigators hope to compare the tissue yields of a     22-gauge fine needle biopsy (FNB) needle, in comparison to conventional 19-gauge. The     investigators predict that 19 and 22 gauge FNB needle will demonstrate similar diagnostic     accuracy, with less visible blood artifact. Similarly the investigators predict the safety to     be equal.   "
24271|NCT02967978|"     The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in urine     and serum differs between postmenopausal women aged 50 to 75 years suffering from     osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used     for the diagnosis of osteoporosis or whether further parameters have to be included.   "
24272|NCT02967965|"     CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and     undergoing reperfusion therapy. Therefore, male and female patients older than 35 years and     younger than 80 years with onset of chest pain of less than 12 hours who need a primary     percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be     recruited.   "
24273|NCT02967952|"     In this 3-year successive research plan, investigators will conduct a prehospital randomized     controlled trial to address the following question: In adult patients with non-traumatic     cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician     (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation     cause a better chance of sustained recovery of spontaneous circulation and other survival     outcomes like neurologically favorable status, comparing to those who receiving supraglottic     airway device.   "
24274|NCT02967939|"     A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic     hepatitis B patients   "
24275|NCT02967926|"     This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to     facilitate common bile duct stone removal without fluoroscopy   "
24276|NCT02967913|"     The bladder flap at the time of cesarean delivery is the term used to describe the separation     of the bladder from the lower uterine segment by sharply incising the vesico-uterine     peritoneum or serosa and using blunt and/or sharp dissection to develop this potential space     which facilitates placement of a retractor, known as the bladder blade. Creating a bladder     flap at the time of cesarean delivery is largely based on individual practice patterns and     practitioners are divided in their use of this step. While creating a bladder flap has a     theoretical advantage of protecting the bladder from injury, it is unknown whether this step     has an effect on postoperative bladder function. The purpose of this study was to evaluate     whether the omission or creation of a bladder flap results in a change in urinary symptoms as     measured by the UDI-6 component of the PFDI-20.   "
24278|NCT02967887|"     This study is to assess the efficacy and the safety of hepatic arterial infusion of cisplatin     and 5-fluorouracil (HAIC) in advanced HCC patients stratified by biomarker expression     predicting therapeutic response.   "
24279|NCT02967874|"     Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations     (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and     thus are potentially important as new therapeutic tools for the repair and regeneration of     acute and chronically damaged tissues.      The general objective of this study is to evaluate safety and clinical efficacy of a single     intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with     knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic     agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a     treatment reduces pain, increases function and reduces stiffness in the knees of     osteoarthritic subjects.   "
24283|NCT02967822|"     In order to understand the molecular mechanisms leading to Mayer-Rokitansky-Kuster-Hauser     syndrome (MRKH), the research team has to identify molecular bases of this anomaly.      Toward this goal, the research team would like to include in the study patients with MRKH     syndrome, as well as their healthy relatives, in order to perform genetic analyses,     especially whole exome sequencing.      This study has been set up in order to collect biological samples from patients with MRKH and     their relatives.   "
24284|NCT02967809|"     Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves     the performances diagnose in the bed of patient in department of conventional medicine.      The concordance between the initial medical diagnosis (previous the utilsation of portable     echograph) and the final diagnosis (after portable echograph utisation) will be evaluated.     These evaluation will be performed after retrospective review of the medical files   "
24285|NCT02967796|"     The aim of the study is to evaluate in primiparous patients the benefit of supplementation     with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture.     The patient is followed from the delivery to 6 to 8 weeks after.   "
24311|NCT02967458|"     This is a phase II single center study using contrast-enhanced ultrasound to identify     aggressive forms of prostate cancer with subharmonic imaging.      The following are the study objectives:        1. To implement subharmonic imaging technology on a transrectal probe suitable for prostate          imaging and biopsy        2. To demonstrate visualization of prostatic vascularity using subharmonic          contrast-enhanced imaging.        3. To provide a preliminary estimate of the diagnostic accuracy of contrast-enhanced          subharmonic imaging for detection of clinically significant PCa.      The study will include 50 subjects who are scheduled for prostate biopsy. Each subject will     receive an intravenous infusion of microbubble contrast material immediately prior to a     prostate biopsy procedure. The study will demonstrate whether subharmonic imaging with a     microbubble contrast agent allows for detection of clinically significant prostate cancer.   "
29685|NCT02897115|"     A study comparing a treat-to-target (T2T) intense treatment approach in participants with     axial spondyloarthritis (axSpA) with routine treatment (Standard of Care (SOC)) concerning a     reduction in disease activity.   "
24286|NCT02967783|"     The introduction of one dose of the inactivated poliovirus vaccine (IPV) into routine     immunization schedules in OPV-only using countries as part of the Global Polio Eradication     Initiative (GPEI) was planned for completion in 2016. However, due to recent developments in     the global IPV supply landscape, the GPEI polio eradication program is facing a critical     shortage of the vaccine which is forecast to continue until at least the end of 2017. The     shortage means that some countries that have already introduced the vaccine, but which are     considered to be relatively low risk (The Gambia included), will be left without adequate     supplies and in other countries IPV introduction is being unavoidably delayed.      Exacerbating the shortage is the need to reserve IPV for future outbreak responses (OBR). The     current OBR protocol recommends that, if a circulating vaccine-derived poliovirus type 2     (cVDPV2) outbreak occurs (after the recent global switch from trivalent to bivalent OPV), a     large scale IPV campaign will be implemented to increase population immunity to the type 2     poliovirus in an large area surrounding the outbreak as high risk of extending transmission.      Due to above, dose-sparing through the administration of intra-dermal (ID) fractional (one     fifth - 0.1mL) doses of IPV (fIPV) has become a very important focus and, for planning     purposes, there is an urgent need to assess the practical and logistic challenges a country     such as The Gambia would face in rapidly undertaking an ID fIPV campaign.   "
24287|NCT02967770|"     The purpose of this study is to determine whether molecularly tailored therapy can improve     the efficacy of treatment when compared to standard chemotherapy combinations for patients     with metastatic pancreatic cancer receiving their second line of therapy for metastatic     disease.   "
24288|NCT02967757|"     This study is conducted in Europe. The aim of this study is to investigate usage of     liraglutide for weight management in clinical practice.   "
24289|NCT02967744|"     The study investigates associations between pre treatment pain intensity and central pain     mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.   "
24290|NCT02967731|"     This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus     Drug Depot in adult subjects with chronic sinusitis.   "
24291|NCT02967718|"     Coronary heart disease is still the major cause of death in China. Chinese medicine plays     more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its     major pathological basis. Based on that, the investigator aims to evaluate the evolutionary     process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section     observation combining with longitudinal tracking on-site survey method so as to guide the     clinical treatment of CHD.   "
24292|NCT02967705|"     This cluster randomized waiting-list controlled pilot study will evaluate the effectiveness     of pain management group activity organized by the OH on pain intensity and associated     disability, and co-occurrence of mental or sleep problem in patients with chronic pain.   "
24293|NCT02967692|"     To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a     BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic     BRAF V600 mutant melanoma   "
24294|NCT02967679|"     The primary objective of the study is to assess the effect of MD1003 on motor and sensory     conduction, in patients suffering from demyelinating polyneuropathies.   "
24295|NCT02967666|"     PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog     tracers has the potential to provide an imaging technique targeting subclinical granulomatous     disease in those with latent tuberculosis (TB), allowing identification of individuals who     may be at risk of progression to active TB.   "
24296|NCT02967653|"     Lithium remains the gold-standard treatment for bipolar disorder, with 30-40% of patients     with responding preferentially to this medication. Additionally, lithium is commonly used in     treatment-resistant depression, and other psychiatric disorders (e.g. schizoaffective     disorder). Lithium is especially valuable considering the great difficulty in achieving and     maintaining symptomatic remission, the high rates of disability, as well as tremendous     personal, family, and societal costs associated with bipolar disorder and treatment-resistant     depression. Despite this, clinicians are increasingly avoiding lithium, largely due to fear     of irreversible chronic kidney disease (CKD), particularly in North America.      It is well known that lithium exposure, even when dosed safely (<1.0mmol/L in adults 11 and     <0.8mmol/L in geriatric patients 12,13), can increase the risk of CKD by 3 times, in large     part through Nephrogenic Diabetes Insipidus (NDI) 14-19. NDI itself has also been associated     with acute kidney injury 20, and life-threatening hypernatremia, which is an electrolyte     imbalance characterized by high levels of blood sodium. Aside from hypertension, diabetes     mellitus, aging, and other nonspecific CKD risk factors.      NDI is characterized by excessive thirst (polydipsia) due to increased production of dilute     urine (polyuria). In NDI, lithium is believed to interact with the inositol monophosphate and     protein kinase C pathways, thereby affecting calcium-related intracellular signaling, cyclic     AMP (cAMP), inhibition of Glycogen Synthase Kinase-3 Beta (GSK3Beta), activation of MAP     Kinase and many other pathways.      NDI occurs commonly in lithium users: 50% of chronic lithium users have urinary concentrating     difficulties, with 12-19% have decreased urine osmolality (UOsm) <300mOsm/Kg).      To date, amiloride (5-20mg/day) is the only medication with prior evidence of therapeutic     effectiveness in NDI from randomized clinical trials. However as a potassium-sparing diuretic     31, amiloride can lead to lithium-level elevations, and can thereby theoretically increase     the risk of lithium-associated CNS and acute renal toxicity.      There is a need for novel, well-tolerated agents for the treatment of lithium-induced NDI.      We recently demonstrated that statins, which are well-tolerated and commonly used     medications, are associated with low lithium-induced NDI risk in the first and only previous     cross-sectional study examining statins and NDI in humans (n=71) 33. In this study we     examined current lithium users aged 20-95, who had a mean lithium duration and serum lithium     level of 10.6 years and 0.62mmol/L, respectively. Patients were assessed for UOsm following     10-hour water-restriction, a reliable measure of NDI. We found that 0% (0/17) of statin users     compared to 20.4% (11/54) on non-users had UOsm <300mOsm/Kg following 10-hour     water-restriction (Fisher's Exact p=0.055). The main statin prescribed in our previous study     was atorvastatin 10-40mg/day (n=10) 33, which is the most widely used statin for     cardiovascular disease. Atorvastatin and other statins are well-tolerated and have not been     found to have adverse effects on mood, cognition, or renal function.      The mechanism by which statins may treat NDI is not yet known, but two independent mice     studies have demonstrated the effectiveness of statins in treating genetic forms of NDI. In     those mice models of genetic NDI, prostaglandin and intracellular cytoskeleton proteins     pathways were thought to explain statins' activity on NDI.      In preparation for this project, our co-investigators Drs. Trepiccione and Christensen have     initiated a pilot study in mice to investigate whether atorvastatin treatment could improve     the lithium-induced NDI. NDI was induced in 10 mice by feeding mice with a LiCl-enriched diet     for 15 days. After induction of NDI, a group of mice received intraperitoneal injection of     atorvastatin (n=5) and a control group received vehicle (n=5) for additional 5 days in     parallel with continued lithium treatment. Although our small statistical sample do not allow     us to reach significance, (n=5 per group), the mice receiving atorvastatin showed a tendency     to reduce polyuria.      In line with this research, our present research protocol aims at conducting a randomized     controlled trial investigating a statin, such as atorvastatin, in the treatment of     lithium-induced NDI.   "
24297|NCT02967640|"     The hypothesis of the present study is that in patients with rotator cuff tendinopathy a     specific pharmacological blocking of peripheral glutamate-receptor N-methyl-d-aspartate     receptor type1 (NMDAR) glutamate receptors will result in pain alleviation. Activated NMDAR1     has been demonstrated to be crucial for pain regulation in various pain disorders, and in     biopsies from patients with tendinopathy, NMDAR1 was found to be activated.      To test this hypothesis a specific NMDA receptor antagonist, ketamine, will be injected     guided by ultrasound into the subacromial space in patients with rotator cuff tendinopathy,     and subsequently the pain response will be assessed.   "
24298|NCT02967627|"     Surgical Site Infections (SSIs) and wound complications are common occurrences following     colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has     developing evidence for improving wound complication rates in certain populations. However,     there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We     propose a study in which patients are randomized into one of two treatment arms: 1)     incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30     days for diagnosis of infection or wound complication. We will compare primary outcomes in     each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction     and Number Needed to Treat   "
24299|NCT02967614|"     To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male     subjects.   "
46195|NCT02680951|"     This study will examine the appropriate dose and side effects of dasatinib, when it is given     with the standard of care chemotherapy for children and adolescents with Acute Myeloid     Leukemia (AML).   "
24300|NCT02967601|"     Background Shivering occurs in circa 50 percent of cases during caesarean section under     spinal anesthesia. The phenomenon's reasons and its mechanism are unclear, and while it does     not endanger the patients' health, the sensations proved to be unpleasant and a subject of a     number of patients' complains.      Objectives The main objective of the study is to establish the anxiety factors that influence     the risk of muscle-shivering and a detailed assessment of the probability of existence of the     link between increased anxiety levels with the shivering in case of patients undergoing the     elective caesarean section.      Moreover, the outcomes of the study could help to further understand the phenomenon, reduce     its occurence and as a result of that - improve the comfort of the patients in the     perioperative period, as well as reduce the frequency of pharmacological treatment to halt     the symptoms of muscle shivering.      Methodology Patients would be asked to fill the STAI (State - Trait Anxiety Inventory)     questionaire in the morning preceding the surgery. Results would be interpreted by one of the     investigators, who obtained a masters degree in psychology. Caesarean section under spinal     anesthesia would be performed according to standard procedures used in the Samodzielny     Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego (SPSK CMKP) hospital,     with standard non-invasive monitoring (HR, noninvasive blood pressure (NIBP), oxygen     saturation (SpO2), Temperature). Additionally, the anesthesiologist would note the incidence     of shivering and its precise timing 1. since the spinal block 2. since the child-birth.     Moreover, patients would rate anesthesiology team influence on her anxiety level during the     cesarean section in 5 grade scale - data would be collected by psychologist.      The survey is planned for a one year timespan or until 200 patients have enrolled.   "
24301|NCT02967588|"     Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal     and is associated with poor clinical outcomes. Non-adherence can be considered intentional or     unintentional. Findings ways to improve adherence is an important area of research with     widespread clinical implications, however, previous interventions have generally been     ineffective. The investigators propose an intervention that challenges both intentional and     unintentional non-adherence in patients hospitalised following ACS.      Objectives The objective of this study is to determine the feasibility of a hospital-based     intervention aimed at supporting medication adherence in patients following an ACS.      Methods Patients admitted to hospital with an ACS will be recruited for this study. The study     will target both intentional and unintentional non-adherence over two sessions through     challenging treatment beliefs and formulating specific action plans to encourage habit     formation. Patients will be asked to provide in-depth feedback around the acceptability of     the intervention. As this is a feasibility study, outcomes (i.e. medication adherence) will     not be collected.      Dissemination If this study seems to be practical to deliver and acceptable to patients then     it will inform the design of a future randomized-controlled pilot study to test the     effectiveness of the intervention delivered by hospital pharmacists on a study outcome (i.e.     medication adherence).   "
24302|NCT02967575|"     This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic     outcome information on patients suffering from intractable symptomatic cervical disc disease     requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the     Triadyme-C polycrystalline diamond compact cervical disc replacement.   "
24303|NCT02967562|"     This study compares a fifteen second sustained inflation (SI) to five repeated two - three     second 'inflation breaths' during resuscitation at delivery of infants born prematurely.   "
24304|NCT02967549|"     This study aims to assess whether neurally adjusted ventilatory assist or proportional assist     ventilation is more effective in infants born prematurely with evolving or established     bronchopulmonary dysplasia   "
24305|NCT02967536|"     Our multi-disciplinary research group works closely with people who have obstructive sleep     apnoea (OSA). This is a life-long illness that causes breathing to stop during sleep, which     leads to low-oxygen in the blood. Breathing restarts when the airway at the back of the     throat reopens, usually during arousal from sleep. In some people the repeated arousals from     sleep cause daytime sleepiness. Our research has shown that the low blood oxygen levels     affect thinking and feeling, and in some cases we think it damages the brain cells involved     with memory, attention, emotions and decision-making.      This study will investigate the relationship between the amount of oxygen in the blood and     the loss (if any) of brain cells. Also how the ability to perform complex tasks is affected     in patients that suffer from sleep apnoea. The results will show whether the brain damage in     patients with sleep apnoea can be reversed with treatment. These findings will guide doctors     in the treatment for sleep apnoea and they will cast light onto the process of memory decline     with the aim to preserve brain function.   "
24306|NCT02967523|"     This project involves the collection and analysis of retrospective and prospective data on     patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision     Infusion System was used/will used be to deliver transarterial chemoembolization with     doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in     a real-world setting as well as identify potential areas for future clinical research.   "
24307|NCT02967510|"     A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group     Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol     Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal     Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy.      Vulvovaginal atrophy is a natural consequence of the progressive estrogen deficiency that     occurs in menopause. Epidemiological data have indicated that about 50% of otherwise healthy     women over 60 years of age experience symptoms related to urogenital atrophy such as vaginal     dryness, dyspareunia, burning, itching, as well as urinary complaints or infections of the     lower urinary tract. As these alterations frequently affect the quality of life of     postmenopausal women, it is important for doctors to detect their presence and offer     treatment options. Estrogen therapy is the most effective treatment of moderate to severe     symptoms of vulvar and vaginal atrophy. One advantage of local treatment with estrogen is     avoidance of first-pass liver metabolism, making it possible to use lower doses of estrogen     compared with oral therapy; the local route also minimize systemic adverse effects. The     search for therapeutic alternatives which may present improvements in relation to the current     products has been encouraged.   "
24308|NCT02967497|"     This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with     cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK     wild type non-small cell lung cancer, stage IIIB-IV.   "
24309|NCT02967484|"     This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke     patients.Half of participants will receive Huo Xue San Feng acupuncture combining 1     antihypertensive medication on the routine ischemic stroke treatments' basis. While the other     half will receive 1 antihypertensive medication and basic treatments for ischemic stroke.   "
24310|NCT02967471|"     Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To     improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS.     This project aims to detect novel biomarkers from peripheral blood , which can improve the     early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.     Clinical data and blood sample were recorded before treatment and after treatment. Acute     Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at     enrolment. Different kinds of lymphocytes from blood samples would be detected by flow     cytometry ,which could be used for discovering high sensitivity and specificity ARDS     biomarker.   "
24324|NCT02967289|"     The trial is a phase III, multicenter, open-labeled randomized trial comparing the     association 5-fluorouracil, folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus     oxaliplatin, folinic acid, 5FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk     stage III colon cancer in the adjuvant setting.   "
24312|NCT02967445|"     Cervical insufficiency, previously referred to as cervical incompetence, has classically been     defined as painless dilation of the cervix in the absence of contractions or bleeding in the     second trimester resulting in recurrent pregnancy losses. Painless mid-trimester cervical     dilation is an uncommon finding in the general population occurring in less than 1% of     pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm     births and/or second trimester losses, as well as second trimester cervical dilatation in the     index pregnancy, was first reported in the 1950's. Cerclage placement in this setting has     been variably referred to as physical exam-indicated cerclage, rescue cerclage, and     emergency cerclage. To date, the benefits of cerclage for this indication are not entirely     clear.      A recent meta-analysis showed that physical exam-indicated cerclage is associated with a     reduction in perinatal mortality and prolongation of pregnancy when compared to no such     cerclage.      Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB     in several populations.      Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary     compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester     cervical dilation   "
24313|NCT02967432|"     The purpose of this study is to determine whether or not mupirocin treatment results in S.     aureus decolonization in affected NICU patients.   "
24314|NCT02967419|"     The purpose of this study is to find out the possible relationship among TWEAK/Fn14,     JAK/STAT3 and IDO as well as their roles in the dysfunction of immune micro-environment of     endometrium in people diagnosed as repeated implantation failure after in vitro     Fertilization-embryo transfer(IVF-ET).      We will use the technology of Western-blot and Immunohistochemistry to find out the     relationship of the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium . Also, we     will use technology of Western-blot and Immunohistochemistry to determine whether there are     differences of the the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium between RIF     group and control group.   "
24315|NCT02967406|"     This is a community-based cluster randomized control trial aimed to investigate the impact of     lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the     development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive     pulmonary disease and cardiovascular disease in an intermediate risk population in mixed     urban-rural areas of Ubon Ratchathani.   "
24316|NCT02967393|"     This study is designed to note whether a larger safety study using quadrivalent live     attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine     (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients     in this study will receive the FLUARIX® influenza vaccine, while the other half will receive     a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as     a surrogate for LAIV4.   "
24317|NCT02967380|"     This pilot clinical trial compares gadobutrol with standard of care contrast agents,     gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced     (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade     II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast agent     that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of the     central nervous system. It is not yet known whether gadobutrol is more effective than     standard of care contrast agents before DCE-MRI in diagnosing patients with multiple     sclerosis, grade II-IV glioma, or tumors that have spread to the brain.   "
24318|NCT02967367|"     During last years, numerous sleep trackers have been commercialized. They are intended to     give indications about sleep quality/duration in order to give people an internet-based     feedback about their own sleep.      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used     routinely to assess objective sleep quality/patterns. Their use is also validated to estimate     sleep in obstructive sleep apnea syndrome (OSA).      The purpose of the present study is to compare the accuracy of consumer-level sleep trackers     and validated tools to measure sleep in OSA patients.   "
24319|NCT02967354|"     Cross-sectional study to investigate subjects at different stages of type 2 diabetes     development with expected stratification of pancreatic islet mass. Non-diabetic individuals     were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and     retention in the pancreas as a surrogate marker for the endogenous islet mass.   "
24320|NCT02967341|"     To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic     studies of ciprofloxacin in patients under treatment for childhood cancer.   "
24436|NCT02965807|"     This study aims to investigate the efficacy and safety of Bronchial Thermoplasty on moderate     bronchial asthma in China, by observing the improvement of quality of life, the decrease of     acute attack and emergence, as well as the incidence of related complications.   "
24437|NCT02965794|"     EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED     FOR COLORECTAL SURGERY   "
24321|NCT02967328|"     Immature platelets—also termed reticulated platelets (RP)—are platelets newly released into     the circulation, and have been associated with a variety of pathological bleeding events     including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM)     after staining with thiazole orange (TO) at low concentration and expressed as a fraction of     the total platelet count (RP%). The diagnosis of primary ITP is based on differential     diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are     useful in daily practice. Our study aimed at distinguishing primary ITP from other     thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced     thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement     between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen     (MAIPA) were analyzed accordingly.   "
24322|NCT02967315|"     The purpose of this study is to evaluate the correlation between fluid volume status and     right ventricular volume and function, in those with free pulmonary valve insufficiency after     Tetralogy of Fallot (TOF) repair.   "
24323|NCT02967302|"     To investigate pain and inflammatory parameters (cytokines, immune cells) in knee joint     tissue of chronic arthritis patients following intraarticular (i.a.) injections of morphine,     a standard steroid or placebo.      The primary hypothesis is that i.a. morphine results in significantly lower pain scores and     supplemental analgesic consumption than placebo during the first week after injection, an     efficacy comparable to standard i.a. steroid (triamcinolone) medication.   "
24325|NCT02967276|"     This phase II trial study assessing the activity of metformin when given together with high     dose of dexamethasone in treating patients with multiple myeloma (MM) that has relapse or     refractory to previous treatment. High dose of dexamethasone (HDdexa) is used to treat     relapse/refractary patients with myeloma and metformin also demonstrated synergistic activity     with dexamethasone to eradicate MM cells in vitro and in vivo. Metformin hydrochloride, used     for diabetes, may also help kill tumor cells. Giving dexamethasone with metformin may kill     more MM cells and increase the response rate to HDdexa.   "
24327|NCT02967250|"     The objective of this study is to understand the bioenergetic impairments that underlie     Parkinson's disease (PD) and evaluating treatments that may improve abnormal mitochondrial     function that is present in PD. The hypothesis is that repeated oral dosing of UDCA will     result in increased brain ATP levels in individuals with Parkinson's disease (PD). The     specific aims are 1.) to measure plasma UDCA levels in individuals with PD at baseline and     after four weeks of repeated high doses of oral UDCA (50mg/kg/day) and 2.) to measure     cortical bioenergetic profile and ATPase activity (as ascertained through MRS) in those with     PD at baseline and at four weeks after repeated high doses of oral UDCA (50mg/kg/day)     simultaneously. Secondary aims are to characterize oral UDCA pharmacokinetics and develop a     pharmacokinetic/pharmacodynamic model to characterize the relationship between peripheral     measurements of UDCA (and associated conjugates) and peripheral measures and/or central     (brain) bioenergetic measurements.   "
24329|NCT02967224|"     Primary Objective:      To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy     measured as glycosylated hemoglobin (HbA1c) change      Secondary Objectives:        -  To demonstrate superiority of Toujeo versus standard of care basal insulin if          noninferiority is met, measured as HbA1c change.        -  To compare Toujeo to other standard of care basal insulin in terms of patient          persistence with assigned basal insulin therapy with or without intensification.        -  Risk of hypoglycemia including the incidence of documented symptomatic or severe          hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on          Hypoglycemia).        -  Change in fasting plasma glucose (FPG).        -  Change in body weight.        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction          Questionnaire Status and Change Versions (DTSQs and DTSQc).        -  Change in hypoglycemic control subscale (HCS)        -  Healthcare resource utilization including hospitalizations and emergency department or          other health care provider visits and healthcare costs.   "
24330|NCT02967211|"     Primary Objective:      To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy as     measured by glycated hemoglobin (HbA1c) change      Secondary Objectives:        -  To demonstrate superiority of Toujeo versus standard of care basal insulin if          non-inferiority criterion is met, measured by HbA1c change.        -  To compare Toujeo to other standard of care basal insulin in terms of patient          persistence with assigned basal insulin therapy with or without intensification.        -  Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or          severe (according to ADA Working Group).        -  Change in fasting plasma glucose (FPG).        -  Change in body weight.        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction          Questionnaire Status and Change versions (DTSQs and DTSQc).        -  Change in hypoglycemic control subscale (HCS).        -  Healthcare resource utilization including hospitalizations and emergency department or          other health care provider visits and healthcare costs.   "
24454|NCT02965573|"     This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to     evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of     autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.   "
24331|NCT02967198|"     The purpose of this study is to determine whether fusion technique of preradiofrequency     ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time     ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor     in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave     elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver     stiffness (LS) with another pSWE technique (ARFI).   "
24332|NCT02967185|"     The proposed study will examine changes in older insomniacs' cognitive functioning following     behavioral treatment for insomnia using a combination of two methods. A traditional repeated     measures design will be used to look at group level differences based on performance on a     neuropsychological battery administered prior to, immediately after, and 3 months after     completing a 4 week behavioral treatment program for insomnia. This data will be analyzed     using standard repeated measures analytic techniques. A time-series design will also be used     to look at within-subject differences based on a brief cognitive battery that will be     self-administered on a daily basis. Data from this daily battery will be examined using     intraindividual variability modeling.   "
24333|NCT02967172|"     The purpose of this study is to determine the efficacy and safety of a peri-articular     multimodal injection for post-operative pain control following operative management of     closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or     not receive intra-operative injections in addition to standard opioid analgesic regimens.     Patients will be treated with standard of care surgical techniques by the treating     orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into     the injection cohort will receive a 25cc intra-operative injection with 200 mg ropivacaine,     0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional     tissues while under general anesthesia. Total post-operative opioid consumption expressed in     morphine equivalent dose will be recorded, including IV and oral opioids. Time in hours from     operation conclusion to discharge and discharge disposition (to where the patient is     discharged) will also be recorded. Post-operative pain scores will be assessed and recorded     in the immediate post-operative period and every 4 hours subsequently until the patient is     discharged. Medication related side effects will be monitored. The investigators hypothesize     that the injection cohort will have reduced pain scores, lower narcotic requirements, shorter     length of stay, and be more likely to discharge to home following surgery.   "
24353|NCT02966899|"     The goal of this study is to elucidate the relationship between myocardial right ventricular     triglyceride content (steatosis) and right ventricular dysfunction in participants with     pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty     acid treatment.   "
24334|NCT02967159|"     AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor     (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary     disease (COPD) and asthma. Abediterol is a novel and selective β2 adrenergic receptor agonist     with the potential for once daily treatment of asthma and COPD in fixed dose combination     (FDC) with an ICS or a novel anti inflammatory (AI) agent. This study will be the first     clinical study for the combination exposure of AZD7594 with abediterol as 2 compounds in FDC     or in free combination via 2 separate dry powder inhalers (DPIs). This study will be     conducted in healthy male subjects to minimize the effects of concomitant disease states or     medications on study measurements.   "
24335|NCT02967146|"     Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and     chitosan(Mediclore®) after axillary dissection for breast cancer   "
24336|NCT02967133|"     The optimal prioritization of second-line chemotherapy and immune therapy based on     demographic or biomarker data is an area of ongoing investigation. The hypothesis of this     study is that there may be an additive or synergistic antitumor effect of combined     chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to     test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need     despite recent clinical research progress. Early progression for a subset of NSCLC patients     receiving nivolumab is a specific area of clinical need.   "
24337|NCT02967120|"     The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic     reagents in early diagnosis of oral cancer.   "
24338|NCT02967107|"     Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection   "
24339|NCT02967094|"     Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy     on visibility of gastric mucosa.   "
24340|NCT02967081|"     The purpose of this study is to determine whether dentinal fluid (tooth fluid) of teeth with     or without a painful inflammatory condition in their nerve (pulp) contain inflammatory     marker.   "
24341|NCT02967068|"     The purpose of this study is to collect existing tissue specimens from subjects enrolled in     Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens     and linked clinical data collected through VCRC studies may lead to the identification and     development of a series of translational research projects. Results of these studies will     provide vasculitis researchers with insight into the causes of these diseases and generate     new ideas for diagnostic tests and therapies, and will be of great interest to the larger     communities of researchers investigating vasculitis and other autoimmune, inflammatory, and     vascular diseases.   "
24350|NCT02966938|"     Food allergies are constantly increasing. Peanut and nut allergies are a major cause of     allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had     an allergic reaction have another one in the following year with the same food, despite a     real improvement in industrial products labeling.      The investigators have observed in the allergy Unit that patients (and/or their family)     following an elimination diet, sometimes since several years, use very strict elimination     strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet,     a good identification of the allergen is the key to a successful elimination and the     non-identification a known risk factor.      Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were     allergic to. However, this is a US study, and geographical specificities have an impact on     food consumption and culture. Food allergology needs to take those two elements into account.     For example, in France, a single food can have two names. It is the case of peanut, which can     be called arachide, or more frequently cacahuète.      The goal of the study is to observe patient aptitudes to recognize peanut (and the     association between the two names) and other nuts available in France and define by the     European law, using a plate with various food samples in seed or in shell.      Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and     their families were surveyed with a standardized procedure at the beginning of their     therapeutic education and their capacity to recognize various nuts, to identify peanut     (cacahuète or arachide) and to associate the two words cacahuète and arachide was     assessed. It is a standard procedure in therapeutic education, and the responses have been     systematically entered in the medical record.      The main objective of this study is to describe peanut or nut allergic patient capacity     (adult, children and/or the family) to visually identify the foods there are allergic to.      The secondary objective of this study is to describe the capacity of patient that describe     themselves as allergic to arachide to associate this word to the word cacahuète.   "
24343|NCT02967042|"     Chronic kidney disease (CKD) is an increasing public health problem and the number of patient     with chronic kidney disease is increasing worldwide. Bone abnormalities are found almost     universally in patients with CKD requiring dialysis and in the majority of patients with CKD     stages 3-5. Chronic kidney disease-mineral bone disorder (CKD-MBD) is a complex disorder of     bone and mineral metabolism, which is associated with disorder in circulating levels of     hormones and development of secondary hyperparathyroid disease. The abnormalities of mineral     homeostasis impair bone remodeling and mineralization and results in cortical and trabecular     defects and an increased fracture risk. There is also an association with increased morbidity     and mortality. CKD-MBD is also associated with development of calcification of the blood     vessels. During the last decade it has been increasingly acknowledged that mineral and bone     disorder contribute to the excessively high cardiovascular morbidity and mortality in     patients with chronic kidney disease. The pathophysiology behind the disorder varies a lot     and can be divided into three groups; high turnover renal bone disease, low-turnover disease     and mixed-uremic osteodystrophy. The treatment of CKD-MBD depends of the subtype of the     disorder.      The diagnosis of CKD-MBD is still challenging. Biomarkers such as parathyroid hormone (PTH)     and alkaline phosphatase (ALP) are used to evaluate bone turnover and formation, but both     biomarkers have several limitations and are both unspecific. Many biomarkers have been used     in research applications, but yet none of them is in clinical use. Dual X ray absorptiometry     (DXA) is used to measure fracture risk in patients with normal kidney function, but is not     useful in patients with chronic kidney disease stage 3 - 5. Different imaging techniques have     been investigated, but still bone biopsy is the golden standard for diagnosing and     classification of the subtypes of CKD-MBD. Bone biopsy is invasive and is not available in     every center.      This study`s goal is to evaluate, if 18-Fluor-Positron emission tomography-computed     tomography (18F-PET-TT) can be used in the assessment of CKD patients. The hypothesis is that     18-PET-TT correlates with the histomorphometry of bone biopsy and with the calcification     score in CKD patients and that 18F-PET-TT maybe can be used as a diagnostic imaging technique     in the future.   "
24354|NCT02966886|"     The primary objective of this study is to determine the difference in disease specific     quality of life outcome measures between patients diagnosed with osteoarthritis of the     shoulder joint whom require a total shoulder replacement between the following study arms:     1)TSA using an augmented component compared with TSA using a standard component with     eccentric reaming in patients 65 years of age or younger or 2) TSA using an augmented     component or reverse shoulder arthroplasty in patients older than 65 years of age as measured     by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score at post-operative     time intervals (ie. 3, 6, 12 and 24 months).      The secondary objective is to determine the difference in disease specific quality of life     between treatment allocations in both age groups as measured by the Constant score, the     American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the     EuroQol Group EQ-5D-5L score at post-operative time intervals (ie. 3, 6, 12 and 24 months).      A secondary objective will be to determine the survivorship of the components as measured by     the degree of radiographic lucencies and component alignment determined by a CT scan at 1 and     5 years post-surgery between study allocations in both age groups.   "
24344|NCT02967029|"     For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide     effective controlled hypotension to reduce blood loss and provide a relatively blood-free     surgical environment to facilitate surgery.      The goal of controlled hypotension is to maintain an arterial blood pressure which is     sufficiently low to allow a reduction in bleeding with offering a superior intraoperative     hemodynamic stability during stressful surgical events to maintain intact cerebral     microcirculatory auto-regulation.      Auto-regulation impairment during controlled hypotension might increase oxygen extraction     ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation     becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a     routine basis.      Various recent studies reported based on facilitating the induction of controlled     hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its     effects on postoperative cognitive function are still poorly characterized. Moreover, the     relationship between rSO2 and controlled hypotension has not been established in patients     undergoing FESS.      Within the last decade, near infrared spectroscopy (NIRS) INVOS® monitors which is clinically     most broadly spread technique, can be used for non-invasive assessment of cerebral perfusion     by detecting changes in rSO2 by online monitoring of cerebral oxygenation.      In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are     the most commonly used hypotensive agents. The aim of this prospective randomized single     blind study was to investigate the influence of remifentanyl as a hypotensive agent in     comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients     undergoing FESS.   "
24345|NCT02967016|"     To the best of the investigators knowledge the average level of physical activity (PA) of     parturients recovering from a cesarean delivery or after a normal spontaneous vaginal     delivery (NSVD) remains unknown. Taking in consideration that parturients are in a     hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most     common causes of maternal morbidity and mortality, ambulation is of utmost importance to     anesthesiologists as well as obstetricians. In order to promote mobility, first the     investigators need to learn the average parturients level of physical activity in the     immediate post-partum period and up to 48 hours after delivery. This information may help us     promote mobility in the immediate postpartum period, particularly for those that underwent a     cesarean delivery since they are at higher risk of VT.   "
24346|NCT02966990|"     The orthotics are auxiliary therapeutic resources indicated for the relief of pain, improves     functional standard or correction of deformities. There is a lack of studies that analyze the     biomechanical changes promoted by the Orthotics in functional pattern of the upper limb. The     objective of this proposal is to analyse biomechanical changes in the functional upper limb     pattern with the use of orthoses for patients with dysfunctions arising from musculoskeletal     system trauma or burns, aiming to contribute with scientific evidence to clinical practice.     The project will analyze the changes in the pattern of the upper limb functional through the     use of dynamic and static Orthotics by means of kinematic and electromyographic analysis     while conducting a functional task. These comparisons will be carried out with and without     the use of functional Orthotics, and the controls are the patients themselves. Methods: 25     patients will be included over 18 years with malfunctions resulting from orthopaedic trauma     and Burns of the upper limb with indication and Orthotics for improving functional pattern.     For characterization of the sample will be performed: esthesiometric , hand and the     (Disabilities of the Arm, Shoulder and Hand) DASH Questionnaire. Biomechanical assessment     will be used for the analysis and electromyographic kinematics. For statistical analysis will     be applied the method of analysis of variance (ANOVA) for repeated measures, and when     necessary, the post hoc Bonferroni test. Will be adopted as significance level p ≤ 0.05.   "
24347|NCT02966977|"     The aim of this study is to evaluate the effect of an extension of conventional urine     diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is     done directly from the urine sample (without an intermediate bacterial culture).The primary     outcome is the time from the entry of a urine sample in the microbiological laboratory to the     adequate/optimal/definitive treatment. Secondary outcomes are the time to diagnosis of a     therapy relevant UTI, the quantity of antibiotics prescribed per patient and ward and a     comparison of the length of hospital stay.   "
24348|NCT02966964|"     The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2     group or control group randomly.      All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day     for 48 weeks. At the same time, all randomized subjects take two pills of Ursa® Tab. or     Placebo of Ursa® Tab. twice a day for 48 weeks.   "
24349|NCT02966951|"     Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed     with Knee osteoarthrosis   "
24390|NCT02966418|"     The purpose of this study is to assess whether a large clinical trial testing the effect of     mild hypoxia preconditioning on neurologic outcome in patients undergoing interventional     treatment is warranted.   "
24470|NCT02965365|"     This study aims to find out whether diagnosis of Transient Tachypnea of the Newborn(TTN) can     be predicted via evaluating pulmonary artery Doppler indices.   "
24351|NCT02966925|"     Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms     of vaginal atrophy include dryness, itching, burning and dyspareunia.      This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to     hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from     reference treatments (hormonal therapies).To achieve this, 20 patients suffering from     vulvovaginal dryness will be treated with one session of injections in the vulva, the     posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal     dryness will be primarily appreciated through Friedmann score and pH value, and secondarily     through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6     months after the treatment.   "
24352|NCT02966912|"     The objective of this study is to investigate whether nutritional supplementation with     magnesium can improve cardiovascular structure and function in participants with obesity -     with a long-term goal of preventing clinical heart failure. Specifically, in a randomized     open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus     no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.   "
24358|NCT02966834|"     This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672     administration for the treatment of pruritus (itch) in participants with primary biliary     cholangitis (PBC). Participants will be treated with either placebo or one of the 4 dose     regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice     daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding. The     total duration of a subject's participation will be up to 45 days of screening and 24 weeks     of study including follow-up.   "
24359|NCT02966821|"     A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of     sulfatinib as a second-line treatment in patients with surgically unresectable or metastatic     biliary tract carcinoma   "
24360|NCT02966808|"     Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost     93% of patients in the first 15 years of the disease, being a clear problem for their normal     living. Nevertheless, therapeutic options for this symptom are few and optimal for only some     patients.   "
24361|NCT02966795|"     A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir     (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants with     chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated     cirrhosis, who are either HCV treatment-naïve or treatment experienced with interferon (IFN)     or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R     treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF     plus RBV treatment-experienced).   "
24362|NCT02966782|"     This is a Phase 1b, dose-ranging, open-label, multicenter study designed to evaluate the     safety, pharmacokinetics, and efficacy of venetoclax as a single-agent and in combination     with azacitidine in participants with higher-risk Myelodysplastic Syndromes (MDS) after     Hypomethylating Agent (HMA)-Failure.   "
24363|NCT02966769|"     The objective of this multicenter retrospective study is to compare overall survival in     patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus     definitive chemoradiation.      Secondary objectives are to analyze disease-free survival, median survival, locoregional and     distant relapses as well as mortality and toxicity related to treatment.   "
24364|NCT02966756|"     This is a Phase 2, open-label, single-arm, multicenter study, evaluating the efficacy of     venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in     the presence of 17p deletion.   "
24365|NCT02966743|"     Compare the changes of regional cerebral oxygen saturation during midazolam or     dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur     surgery.   "
24391|NCT02966405|"     A descriptive analysis involving 300 healthy pregnant women to the establish of     trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were     selected as the normal pregnant population to establish a self-sequential longitudinal     reference range.   "
24366|NCT02966730|"     The purpose of this study is to find out how successful ibrutinib is at putting follicular     lymphoma into full remission. In this study, remission will be determined by achieving a     normal PET scan after treatment. A PET scan is an imaging test that looks for active     lymphoma. People who don't have a complete remission on PET after their first treatment are     at high risk for having their lymphoma return. This study will investigate if ibrutinib will     help participants achieve a complete remission without giving additional chemotherapy. The     study will also investigate any possible side effects of the study drug ibrutinib.   "
24367|NCT02966717|"     Primary nephrotic syndrome(PNS) is a group of clinical symptoms caused by a variety of     factors, including immune,environmental, genetic, et al. Oral corticosteroids have been to be     the preferred drug for the treatment of PNS, but the long-term use of glucocorticoid therapy     in clinic often induces some problems such as hormone dependent and hormone resistance, as     well as severe side effects which act as a threat to the patients' health. Besides, patients     with proteinuria long-term not control often behave faster progression into chronic renal     failure, leading to poor prognosis. In renal diseases, Rituximab ( RTX) is often used in the     treatment of refractory nephropathy, such as hormone dependent nephrotic syndrome, hormone     resistance nephrotic syndrome, frequency recurrence nephrotic syndrome, which shows exciting     effects in delaying the development of the disease.At present, mesenchymal stem cells ( MSCs)     has been used as a research hotspot to repair the tissue damage of chronic kidney disease,     and it also behaves certain effects. The purpose of this study is to seek a more targeted     treatment, more precise curative effect and more feasibility treatment for PNS(CKD3-4),so as     to delay or reverse the disease and improve the quality of life of patients with CKD.   "
24368|NCT02966704|"     The evaluation of protein quality has been identified as the top priority question by the     Food and Agricultural Organization (FAO) of the United Nations. However, the current     available methods do not precisely estimate protein quality, or need invasive procedures. The     proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in     humans.      The present project characterizes the use of 15N-intrinsically-labelled milk protein as a     reference-protein for development a non-invasive method that can be used to assess protein     quality in human subjects   "
24369|NCT02966691|"     This clinical study is designed to evaluate the diagnostic performance of VisioCyt test,     which would improve the early diagnosis of bladder cancer in order to optimize the management     of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of     VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary     cytology slides prepared according to the protocol VisioCyt.   "
24370|NCT02966678|"     Incidence of dyschromatopsia   "
24383|NCT02966509|"     The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained     lay health coaches to engage patients and their families in goals of care and shared     decision-making after a diagnosis of advanced cancer. Although lay health workers have never     been tested in this role, we hypothesize that lay health workers can feasibly improve goals     of care documentation and help to reduce unwanted healthcare utilization at the end of life     for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent     disease.   "
27042|NCT02931773|"     The investigators are studying the initial autonomic alterations in participants recently     diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the     baroreceptor sensitivity and on the peripheral sympathetic innervation.   "
24371|NCT02966665|"     Many control mechanisms exist which successfully match the supply of blood with the metabolic     demand of various tissues under wide-ranging conditions. One primary regulator of vasomotion     and thus perfusion to the muscle tissue is the host of chemical factors originating from the     vascular endothelium and the muscle tissue, which collectively sets the level of vascular     tone. With advancing age and in many disease states, deleterious adaptations in the     production and sensitivity of these vasodilator and vasoconstrictor substances may be     observed, leading to a reduction in skeletal muscle blood flow and compromised perfusion to     the muscle tissue. Adequate perfusion is particularly important during exercise to meet the     increased metabolic demand of the exercising tissue, and thus any condition that reduces     tissue perfusion may limit the capacity for physical activity. As it is now well established     that regular physical activity is a key component in maintaining cardiovascular health with     advancing age, there is a clear need for further studies in populations where vascular     dysfunction is compromised, with the goal of identifying the mechanisms responsible for the     dysfunction and exploring whether these maladaptations may be remediable. Thus, to better     understand the etiology of these vascular adaptations in health and disease, the current     proposal is designed to study changes in vascular function with advancing age, and also     examine peripheral vascular changes in patients suffering from chronic obstructive pulmonary     disease (COPD), Sepsis, Pulmonary Hypertension, and cardiovascular disease. While there are     clearly a host of vasoactive substances which collectively act to govern vasoconstriction     both at rest and during exercise, four specific pathways that may be implicated have been     identified in these populations: Angiotensin-II (ANG-II), Endothelin-1 (ET-1), Nitric Oxide     (NO), and oxidative stress.   "
24372|NCT02966652|"     DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency     in men. The proposed study is a Phase 1 clinical study in hypogonadal men, defined according     to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK)     characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target     population.   "
24373|NCT02966639|"     The main objective of this study is the external validation of the appropriateness criteria     for the surgical treatment of Lumbar Degenerative Spondylolisthesis. We will assess,     prospectively, whether patients treated appropriately have better outcomes than those     treated inappropriately according to the RAND Appropriateness Method (RAM) Criteria.   "
24374|NCT02966626|"     Type 2 diabetes is creating a health pandemic globally. Management of type 2 diabetes     involves combination of lifestyle intervention and drug intervention, which includes     sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin     (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes     in 2014. This study will describe the characteristics of patients who are prescribed     dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe     their glycaemic control, weight, and renal function at baseline and during use of     dapagliflozin.   "
24375|NCT02966613|"     To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with     fully disposable patient-specific instrumentation versus conventional, versus patient     specific instrumentation.   "
24376|NCT02966600|"     The aim of this randomized controlled trial was to assess the impact of progressive     resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The     investigators hypothesized the intervention would have a beneficial effect on the study     outcomes.   "
24377|NCT02966587|"     This phase II trial studies how well durvalumab works in treating patients with prostate     cancer that is resistant to hormones and has spread to other places in the body. Monoclonal     antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and     spread.   "
24392|NCT02966392|"     The purpose of the study is to determine whether automated cuff pressure control results in a     reduction in the proportion of patients developing ventilator associated respiratory     infections during their stay in intensive care.   "
24471|NCT02965352|"     This study has developed a peripheral to quantify the functional strength of children without     motor change during the movement of grip and pinch. It was possible to know the exact values     of these strengths, the range of motion that was made, and also if the grip strength was     maintained during all the arc of motion.   "
24378|NCT02966574|"     Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated     its interest in metastatic cancers. Breast cancers, especially hormone-sensitive ones, are     very osteophilic and bones are the most frequent metastatic site.      Apart from morphological criteria (lesion size and RECIST criteria), MRI provides     quantitative functional criteria (diffusion and ADC values). According to a recent study,     whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the     diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.      Therefore, it seems appropriate to study the performance of whole body MRI in the     pre-therapeutic assessment of breast cancer with a high risk for metastasis and the     monitoring of metastatic breast cancer.   "
24379|NCT02966561|"     The STAR-study (STay Active after Rehabilitation) investigates in a randomized controlled     trial (RCT) the additional effect of a pedometer-based behavior change intervention (BCI)     during in-patient pulmonary rehabilitation (PR) on objectively measured physical activity     (PA) 6-weeks and 6-months post PR. The BCI uses the behaviour change techniques a)     instruction on how, where and when to perform the behavior, b) prompt goal setting for     physical activity, c) prompt self-monitoring of behavior and d) feedback on behavior. The     primary outcome of PA will be measured using an accelerometer (Actigraph wGT3X) for a time     period of seven days, firstly two weeks before rehabilitation begins (T0 = study phase I) as     well as six weeks and six months (T3 and T4) after PR. Additionally to predict PA progression     after PR, a complex personal diagnostic, including questionnaires as well as functional     assessments, is to be carried out at the start (T1 = start of study phase II) and end of PR     (T2). This diagnostic is based on the main ideas of the PA-related health competence model     (PARC-model) and especially incorporates physical and psychological personal determinants of     PA.   "
24380|NCT02966548|"     This study will be used to determine the safety and tolerability of BMS-986016 administered     alone and in combination with Nivolumab in subjects with advanced solid tumors.   "
24381|NCT02966535|"     Gas exchange disturbance frequently occurs in steep Trendelenburg position during     robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic     pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia     as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during     mechanical ventilation has been reported to be improve gas exchange in adult respiratory     distress syndrome. The investigators attempt to test the hypothesis that prolonged     inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic     surgery.   "
24382|NCT02966522|"     To prove the organ-reversing potential of thalidomide for amyloidosis with cardiac     involvement   "
24385|NCT02966483|"     Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior     alternative regarding resection quality, and oncological outcomes of patients as compared to     open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over     open surgery with regard to operative invasiveness, patient's recovery, and wound related     complications. Thus, laparoscopic surgery has gained great popularity over the past decades.     However, specifically for mid and low rectal cancer, laparoscopic surgery is technically     demanding, which sometimes leads to high morbidity and unsatisfactory resection quality,     especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated     pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so     called down-to-up alternative, has emerged as a promising solution to these problems in     recent years and more and more small studies have proven the feasibility and advantages of     this technique, making it become a hot topic among both literature and conferences. However,     TaTME is still at early birth, higher-level evidences, either multicentric, or comparative     study with conventional surgery is strikingly lacking. Thus the investigators conduct this     multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for     mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better     resection quality and result in non-inferior oncological outcome, as well as short term     operative morbidity and mortality.   "
24386|NCT02966470|"     This study aims to assess if grip strength can be used as a single, objective surrogate of     frailty assessment in the surgical population.   "
24387|NCT02966457|"     MDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of     bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It was     previously shown, that intestinal colonization with extended-spectrum β-lactamases     (ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A.     baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients     with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I. et     al., 2016].      To the investigators knowledge no randomized, placebo-controlled clinical trial has been     performed to study the efficacy and safety of selective intestinal decolonization strategies     in high-risk patients with haematological malignancies. Possible decolonization of MDR     gram-negative bacteria in haematological patients could be important for the patient by     reducing the risk of infection and for the community by reducing the risk of transmission.      The purpose of the proposed study is to assess the efficacy and safety of selective     intestinal decolonization of MDR gram-negative bacteria with oral administration of     Colistimethate sodium in high risk patients with haematological malignancies.   "
24388|NCT02966444|"     This study evaluates the effects of dietary fatty acid composition from high fat meals on     markers of hunger, satiety and metabolism.   "
24389|NCT02966431|"     Determine the effects of an 8-week weight loss intervention.   "
24393|NCT02966379|"     Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO     electrode lead has been specifically designed to preserve this residual hearing through     surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS)     which combines both an acoustical stimulation for the preserved low frequency hearing and an     electrical stimulation through the cochlear implant. The major aim of this study is to     evaluate hearing preservation after implantation with the EVO electrode lead.      The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra     speech processor.   "
24394|NCT02966366|"     Recent studies have reported successful reduction of tinnitus after cochlear implantation     (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not     fully understood. Especially, the relative role of peripheral and central auditory pathways     is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus     in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative     contributions of peripheral and central auditory pathways in tinnitus reduction.   "
24395|NCT02966353|"     This is a study of treatment with ruxolitinib in patients who present with transfusion     dependent or independent anemia with 10 mg BID starting dose and subsequent up titrations     depending on safety and efficacy.   "
24396|NCT02966340|"     Double-blind, placebo-controlled, cross-over design study examining the effects of a     norepinephrine alpha1 receptor antagonist (prazosin) on stress reactivity in a laboratory     stressor task.   "
24397|NCT02966327|"     Objectives: 1) To evaluate the effect of early compression therapy with individualized     exercise on the incidence of lower limb lymphedema at 12 months post-operatively in patients     treated for gynecological cancer who are at risk of developing lymphedema; 2) To evaluate the     effect of early compression therapy with individualized exercise on lower limb volume,     quality of life and incidence of cellulitis infections at 12 months post-operatively in this     population.   "
24398|NCT02966314|"     The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to     2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced     angioedema, the majority of episodes were idiopathic. Idiopathic Angioedema (IAE) can be     life- threatening especially when affecting tissues within the respiratory tract. No clear     guidelines exist for management of this important condition for clinicians. Current therapies     typically include avoidance of potential triggers and use of medications either for     prophylaxis or for acute events, such as antihistamines, corticosteroids, and epinephrine.     There remains a critical need for therapeutic options to provide more effective prophylaxis.   "
24399|NCT02966301|"     This study aims to evaluate the early chronic GvHD events (first line therapy), if the     addition of arsenic trioxide to standard therapy with corticosteroids, with or without     cyclosporine, will be effective in controlling chronic GvHD and to reduce the duration of     corticosteroid therapy   "
24400|NCT02966288|"     The study objective is to determine whether a single intra-articular dose of an     anti-inflammatory (Toradol) will reduce the need for other analgesic medications and, if so,     how long the benefits will last.   "
24401|NCT02966275|"     This study is to test our automated hypoglycemia prevention and treatment device     (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that     are experiencing symptoms of hypoglycemia.   "
24402|NCT02966262|"     All comer registry who had undergone intravascular optical coherence tomography during and/or     after coronary intervention.   "
24405|NCT02966223|"     The primary question of interest is quantifying the relationship between Y-90 liver therapy     and liver damage. Little is known on this subject. Present assumptions and calculations of     Y-90 administration are based on surgical lobar hepatectomies and external radiation beam     therapies. The investigators hope that by using a functional model of the liver, the     investigators can improve this important knowledge gap.      The investigators will be enrolling patients planning to receive Y-90 therapy for the     treatment of liver malignancies. The diagnosis of a primary liver cancer, hepatocellular     carcinoma (HCC), is usually made by a combination of specific imaging findings and clinical     criteria; only rarely is a confirmatory biopsy performed. This is due to the high accuracy of     the present diagnostic model and the significant risk of biopsy and tumor seeding.      Y-90 therapy involves administering radioactive particles to liver tumors by placing a     catheter in a hepatic artery supplying the tumor using angiographic techniques and injection     of these particles.      Y-90 PET/CT imaging has been established as a method to validate and quantitate distribution     of Yttrium after Y-90 administration. The post Y-90 therapy PET/CT images provide an imaging     distribution of the Y-90, which is essential for validation of administered versus planned     dose to the liver lesion and background liver.      If the investigators can compare the Y-90 distribution to estimate background liver radiation     distribution and dose (generated by the Y-90 PET/CT scan) combined with the global and     regional function map (generated by the HIDA scan performed before and after therapy), then     the investigators will be assuming that the difference pre and post therapy in global and     regional function can be ascribed to the Y-90 administration. The investigators will also     analyze the MRI and CT sets performed before and after therapy and correlate the imaging     results collected with clinical findings such as ascites/encephalopathy and routine     serological markers (bilirubin, albumin, INR, etc.). With this information, the investigators     will have the potential to establish whether there is a relationship between Y-90     distribution to non-tumoral (normal) hepatic parenchyma and the incidence and severity of     REILD. This would have the potential to improve selection criteria and outcomes in     populations selected for Y-90 therapy in the future.   "
24406|NCT02966197|"     Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and     even maternal death. Interventional radiological techniques have been developed to limit     massive hemorrhage during caesarean section. This study investigated the efficacy of     prophylactic internal iliac artery balloon catheterization in management for placenta previa     and accreta.   "
24407|NCT02966184|"     This study is designed to compare the length of continuous albuterol administration between     two different albuterol formulations, BAC containing albuterol versus preservative free     albuterol.   "
24408|NCT02966171|"     This is a first-time-in-human, phase I, open-label, dose-escalation study of HMPL-453 in     patients with advanced or metastatic solid malignancies who have failed or are intolerable to     standard therapies or for whom no standard therapies exist. There are preliminary two stages     in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). We     will decide whether to conduct stage 2 or not one month after the last patient included in     stage 1.   "
24409|NCT02966158|"     Heart disease is the number one killer amongst chronic diseases around the world, and it is     responsible for taking the lives of an estimated 17.5 million people each year.     Exercise-based cardiac rehabilitation (CR) programs, which help heart patients improve their     current health, prevent future heart problems, and improve their quality of life, are an     effective strategy for lowering the risk of heart-related deaths in heart patients. CR     programs currently have their patients perform moderate intensity, continuous exercise     (MICE), which traditionally takes the form of walking, jogging, or cycling at a comfortable     pace for 30-60 minutes. Recently, aerobic interval training (AIT), which involves performing     short bouts of exercise, typically ranging from 15 seconds to four minutes at near maximal     effort, followed by periods of recovery or rest, has emerged as a more effective strategy     than MICE for lowering the risk of heart-related deaths in heart patients. Although these     initial findings appear to hold much promise for improving CR programs in the future, it is     important to recognize that women have been underrepresented or not included in these studies     to date. Therefore, the goal of this study is to determine the effects of AIT versus MICE on     the risk of heart-related death, blood vessel health, and brain health in women who have     heart disease, and who have been referred to a six-month, outpatient CR program.   "
24410|NCT02966145|"     The goal of this study is to identify the most reliable methods of analysis for tracking CBD,     PSP, and o/vPSP over time. The results from this study may be used in the future to calculate     statistical power for clinical drug trials. The study will also provide information about the     relative value of novel imaging techniques for diagnosis, as well as the value of imaging     techniques versus testing of blood, urine, and cerebrospinal fluid (CSF) 'biomarkers'.   "
24411|NCT02966132|"     The primary aim of the proposed study is to conduct a randomized controlled trial (RCT) to     evaluate the efficacy of the Interactive Mobile Doctor (iMD) intervention targeting 150     Chinese-, Korean- or Vietnamese-speaking male patients who smoke daily and have a scheduled     clinic visit at Asian Health Services primary care.   "
24412|NCT02966119|"     RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral     haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet     medication) for the prevention of vaso-occlusive disease before the ICH.      RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of     aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a     beneficial net reduction of all serious vascular events over two years compared with a policy     of avoiding antiplatelet drugs.   "
24413|NCT02966106|"     rTMS has appeared a potential new non-invasive antidepressant method, which implies     non-convulsive focal stimulation of the brain through a time varying magnetic field. ).     Research on rTMS reports of minimal side effects of the method . The majority of clinically     controlled studies have used high frequency stimulation of the left frontal cortex .      Fewer studies have used right prefrontal, which has less side effects, such as local     discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation     .Both stimulus models has been shown to have statistically significant antidepressant effect     and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex     i associated with an antidepressant effect at the same level as the high frequency model.     Therefore the investigators want to examine the antidepressant effect of a specific rTMS low     frequency model in a clinical setting using a placebo controlled, randomized double blind     design.   "
24414|NCT02966093|"     The primary purpose of this study is to compare the progression-free survival (PFS) of     participants with radioiodine (131 I)-refractory differentiated thyroid cancer (DTC) and     radiographic evidence of disease progression within the prior 12 months treated with     lenvatinib 24 mg by continuous once daily (QD) oral dosing versus placebo.   "
24466|NCT02965417|"     This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic     colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor     (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR     (ECD-EGFR).   "
24416|NCT02966067|"     The study will be completed as a two part, prospective, single-centre, randomised controlled     trial.      Five volunteers (dentists) will be recruited in the first part of the study to evaluate and     examine the microneedle device and its use. Based on those qualitative findings (individual     interviews and focus group) modifications to the microneedle device will be implemented     before part two of the study commences.      Twenty volunteers will be enrolled in the second part of the study. A split mouth design will     be used to compare the efficacy of an array of 2x3 pyramidal wet-etch silicone microneedles     of 280µm height with a standard 30-gauge short hypodermic needle in the delivery of local     dental anaesthetic solution. Quantitative and qualitative measurements of the pain     experienced and the depth of anaesthesia achieved will be recorded and compared.   "
24417|NCT02966054|"     Epidemiologic data consistently indicate that colorectal cancer survivors can improve their     quality-of-life and prognosis by engaging in physical activity. This study aims to build on     this epidemiologic work and translate the findings to inform and change patient behavior. The     specific aims are to: (1) Develop a mobile technology physical activity intervention among     colorectal cancer patients who have completed therapy. (2) Conduct a 3-month pilot randomized     controlled trial utilizing mobile technology to increase physical activity among 40 men and     women who have completed standard cytotoxic chemotherapy for primary stage I-III colorectal     cancer at the UCSF Helen Diller Family Comprehensive Cancer Center. Participants in the     intervention arm will receive a Fitbit® for self-monitoring, interactive text messages, and     educational print materials; participants in the control arm will receive educational print     materials at baseline and will be given a Fitbit® after completion of the 3-mo. follow-up     assessment.   "
24418|NCT02966041|"     To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the     incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation     of post-operative sedation. In patients who have undergone open heart surgery, a single     prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol sedation     will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first     24 post-operative hours compared to placebo.   "
24421|NCT02966002|"     Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop     complications many years after their operation. Studies have shown that some of these     patients develop an ongoing inflammatory state, which may be the cause of these late     complications. Aspirin is a common over the counter anti-inflammatory medication used for     many other chronic diseases. This study may help determine if aspirin therapy can limit the     inflammation seen in Fontan patients and prevent these late complications.   "
24422|NCT02965989|"     This study evaluates if the implementation of an online platform with procedures and     protocols, improve the knowledge of professionals and can have a health impact related to     decreased contamination of blood cultures.   "
24423|NCT02965976|"     This randomized phase II trial studies how well botulinum toxin type A works in preventing     complication after surgery in patients with esophageal cancer. Botulinum toxin type A may     cause less complications of nausea and vomiting after surgery.   "
24424|NCT02965963|"     The purpose of this study is to examine the effect of dopamine infusion and dopamine-2     receptor blockade on pulmonary capillary blood volume, diffusion, and the hemodynamic     variables of pulmonary artery pressure, cardiac output, and pulmonary vascular resistance     during exercise. Secondarily, this study will examine the effect of dopamine infusion and     dopamine-2 receptor blockade on exercise tolerance.   "
24425|NCT02965950|"     This is a multicenter, open labeled, phase 2 clinical trial, where patients are stratified to     one of two treatment groups based on upfront TP53 mutation status; i.e. TP53 mutated vs. TP53     wt disease, and treated with dose-dense cyclphosphamide. Furthermore, patients included are     stratified based on tumor stage; i.e. locally advanced breast cancer (M0 disease) or     metastatic breast cancer (M1 disease). All participating cancer centers will prospectively     include patients with breast cancer fulfilling the inclusion criteria.      If patients do not respond to the experimental treatment as outlined in the protocol,     treatment with dose-dense cyclophosphamide will be terminated, and further cancer treatment     will continue at the treating oncologist's discretion. The response data for all patients who     have received at least one chemotherapy course will be included in the final efficacy     analysis.      Tumor tissue, blood samples and radiology data will be collected before therapy starts, if     therapy needs to be changed, and for patients with locally advanced breast cancer: at     surgery. Response data will be evaluated closely during treatment, with clinical assessment     of tumor size every two weeks for patients with locally advanced breast cancer and by     radiology every eight weeks for patients with metastatic breast cancer. Evaluation of side     effects/tolerance will be performed at every clinical visit, i.e. every two weeks for all     patients included in the p53 trial.   "
24426|NCT02965937|"     The study aim is to evaluate the effectiveness of Story-Centred Care Intervention Program on     reducing depressive symptoms, improving cognitive function, HRV, Blood pressure and quality     of life in older adults living in a long-term care facility.   "
24427|NCT02965924|"     Phenylephrine hydrochloride ophthalmic solution is an alpha-1 adrenergic receptor agonist     commonly used topically for dilation prior to ocular fundus examination. In the eye,     phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting     ophthalmic blood vessels and the radial dilator muscle of the iris. Episcleral venous     pressure (EVP) is a determinant of intraocular pressure (IOP) and can be measured     non-invasively by venomanometry. Since phenylephrine is a vasoconstrictor, it may affect     episcleral venous tone, but the effect on EVP is unknown. Understanding the physiology of     episcleral veins helps us in better understanding of pathophysiology of glaucoma.   "
24428|NCT02965911|"     The purpose of this protocol is to conduct a trial in a selected population of patients with     PBC based on an incomplete biochemical response after 12 months of UDCA therapy.   "
24449|NCT02965638|"     The purpose of this study is to determine if maternal hyperoxygenation is an effective     treatment for fetal left heart hypoplasia versus room air (placebo). This will be determined     by measuring how well a baby's heart valves and their surrounding tissue are growing and     functioning.      In addition the investigators will examine brain growth using fetal ultrasound and MRI, and     MRI of the child's brain after they are born to determine if there is greater neonatal brain     maturity or mothers receiving oxygen compared to fetuses of mothers receiving placebo.   "
24429|NCT02965898|"     Acute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology     is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP     patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency.      Recently, the investigators and others have found that vitamin D may protect from the     formation of fibrosis on cellular level. The investigators hypothesized that after the first     AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and     designed this RCT.      The aim is to study whether the investigators can prevent CP with vitamin D substitute.      In this randomized controlled patient study, the patients after their first AP are randomized     to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin D     substitute daily. The patients are examined by MRI/MRCP imaging and laboratory tests at the     baseline after recovery from AP and yearly then after.      Primary endpoint is the development of parenchymal changes possibly related to fibrosis.     Secondary endpoints are the development of CP with Mannheim criteria, CP related     complications and mortality.      The first analysis will be done after 3 years.      The enrollment will begin 26.9.2016   "
24430|NCT02965885|"     A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first     initiated in Japan in April 2014 and has been ongoing since then. The study consists of a     dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once     daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are     being evaluated. This phase I study is also planned to enrol with advanced solid tumors in UK     to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western     patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC     harbouring EGFR mutations (EGFRT790M+) or EGFR mutations (T790M-) will be further evaluated     for safety, tolerability and efficacy in 3 separate cohorts at recommended dose of TAS-116 on     the 5 days on/2 days off regimen.   "
24431|NCT02965872|"     Thirty healthy individuals will be participants of the study. Participants will evaluate with     the following assessment tools: Demographic datas; age, gender, height, body mass, will be     recorded. Postural sway and limits of stability parameters will evaluate with computerized     balance evaluation system (BERTEC) for seven times .   "
24432|NCT02965859|"     The study objective is to evaluate the safety and effectiveness of different doses of     Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an     appropriate clinical dosage by comparing the effect of different doses of treatment,in order     to provide references of clinical trial of the next phase.   "
24438|NCT02965781|"     This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes     labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the     other third will receive only the vehicle as a placebo control. The solutions will be     administered topically to the patient's arms. The study will compare a single-arm application     versus a two-arm application versus two placebo doses on the arm.   "
24439|NCT02965768|"     The main objective of this study is to test if naltrexone, when taken in low doses, has an     anti-inflammatory effect that may be associated with positive clinical outcomes in people     with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior     work in which we showed that chronic fatigue symptoms are associated with immune activity,     and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is     thought to share some pathophysiological and clinical characteristics with CFS.   "
24440|NCT02965755|"     The goal of this research study is to determine if we can obtain personalized genetic     information from a subject's blood sample that is similar to that obtained from a tumor     tissue sample, and if we can use that information to make treatment suggestions.   "
24441|NCT02965742|"     The main objective of this study is to assess the concordance of body composition measures     between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and     the Hologic QDR 4500 A by Hologic inc.   "
24442|NCT02965729|"     The purpose of the study was to examine the influence of step goals with pedometers to     improve children's weight loss, physical activity, and psychosocial health during behavioral     treatment. Children with overweight or obesity were assigned to receive the behavioral     treatment alone, plus pedometers, or plus pedometers with step goals.   "
24443|NCT02965716|"     This phase II trial studies how well talimogene laherparepvec and pembrolizumab work in     treating patients with stage III-IV melanoma. Biological therapies, such as talimogene     laherparepvec, use substances made from living organisms that may stimulate or suppress the     immune system in different ways and stop tumor cells from growing. Monoclonal antibodies,     such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.     Giving talimogene laherparepvec and pembrolizumab may work better in treating patients with     melanoma by shrinking the tumor.   "
24444|NCT02965703|"     This randomized phase IIa trial studies how well aspirin works in preventing colorectal     cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth   "
24445|NCT02965690|"     Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees.     Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant     survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of     the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have     been developed to solve the problem. However, most of their designs are based on experimental     data and little has been studied about their kinematics in vivo. In this study, we will     analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and     compare it with a well documented design and implant (Nexgen Cruciate Retaining (CR), Zimmer     Biomet). We assume our study will contribute the development of more satisfying knee     implants.   "
24446|NCT02965677|"     To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation     Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of     stenosis or occlusions in femoral popliteal artery.   "
24447|NCT02965664|"     A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic     Subjects.   "
24448|NCT02965651|"     The purpose of this randomized controlled trial is to evaluate the feasibility of introducing     an innovative eHealth technology, the Embodied Conversational Agent (ECA), to diverse women     from an urban outpatient setting.   "
24450|NCT02965625|"     Human epicardial fat is the true visceral fat depot of the heart, and its regional     distribution and physiology is of growing scientific and clinical interest. This study aims     to characterize the expression profile and function of the epicardial and pericardial adipose     tissue compartments of the heart (EAT and PAT). EAT and PAT adipose biopsies will be obtained     from patients undergoing coronary artery bypass graft surgery (CABG) or valve replacement     surgery.   "
24451|NCT02965612|"     The recent interest that the Specific Immunotherapy (ITS) has aroused is due to the positive     potential role that could be played, in particular in the forms of allergic asthma, because     this method constitute the only intervention (unlike that pharmacologic) able to act on the     same causes of the disease, altering the natural history. To achieve this the investigator     has tried to use the specific subcutaneous immunotherapy (SCIT), to which there are studies     that, with scientific rigor, have demonstrated the benefits.   "
24453|NCT02965586|"     compare the efficacy of intrathecal versus intravenous dexmedetomidine in attenuation and     prevention of shivering in TURP under spinal anesthesia in a randomized controlled trial.   "
24455|NCT02965560|"     Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure     (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are     characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic     inflammation and alleviate liver injury in mice model. However, there are no studies     evaluating PGE2 as a predictor of early mortality.This study is designed to investigate     whether plasma PGE2 and its receptors are associated with development of MOF and predict     short-term mortality in patients with acute-on-chronic liver failure. By the way, we will     also measure several other potential predictive factors (C-reactive protein,severe     hyponatremia, Second infections,Diabetes mellitus,High density     lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte     ratio,urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).   "
24456|NCT02965547|"     The purpose of this study is to determine the impact of remote ischemic preconditioning on     dynamic cerebral autoregulation and related hematology indexes in healthy adults.   "
24457|NCT02965534|"     Reduced quality of vision and glare in twilight or night are frequently mentioned complaints     within the optometric examination. A reason for these problems could be a myopic refractive     shift in dark light conditions, commonly known as night myopia or twilight myopia.      The aim of this study was to investigate whether quality of vision in twilight or night could     be improved by a spectacle correction optimized for mesopic light conditions. Moreover,     objective refraction in large pupils measured by aberrometry was compared to subjective     mesopic refraction.   "
24458|NCT02965521|"     Epidemiologic data suggest that a Western dietary pattern after diagnosis of colorectal     cancer increases risk of disease recurrence and death. High intake of red and processed meat,     dairy, refined grains, and sweets/desserts characterize a 'Western dietary pattern'. This     study aims to translate the epidemiologic findings into a patient-centered, web-based dietary     intervention with text messaging to inform and modify users' dietary choices. The     investigators' specific aims are to: 1) Develop a web-based dietary intervention with text     messaging for colorectal cancer survivors; and 2) Conduct a 12-week pilot randomized     controlled trial to determine the acceptability and feasibility of the dietary intervention     among 50 colorectal cancer survivors. All participants will receive standard of care print     materials regarding diet following a colorectal cancer diagnosis. Participants in the     intervention group will also receive access to a web-based dietary intervention with text     messaging for 12 weeks. This study will generate preliminary data on the effect of the     intervention on dietary choices among colorectal cancer survivors for future studies.   "
24459|NCT02965508|"     The objective of this pragmatic randomized controlled trial is to compare the impact of     physician directed home-based primary care with office-based primary care on     hospitalizations, symptom control, caregiver burden, healthcare costs and other outcomes for     older homebound adults and to conduct a dissemination and implementation evaluation to     support future home-based primary care adoption   "
24460|NCT02965495|"     This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa     clinical trial of YYD302 for treatment of osteoarthritis of the knee.   "
24461|NCT02965482|"     The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating     mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the     Wright jet nebulizer) for methacholine challenge testing. The results will then give an     indication as to whether the novel technique accurately assesses a given dose of methacholine     with the new Aerogen Solo device. In addition, the reproducibility of test results with each     method will be examined. Altogether, the findings from this investigation may provide means     for better standardization of current testing guidelines.   "
24462|NCT02965469|"     This study will begin to assess the association between perceived stress and enhanced aging     in persons living with HIV (PLWH). The investigators suspect this relationship may be     mediated by increased aging within the immune system and subsequent low-level inflammation     that commonly leads to multiple illnesses and frailty as one ages. The findings from this     study will identify potential diagnostic and therapeutic targets to improve the health of     aging PLWH which could also apply to HIV-uninfected populations.   "
24463|NCT02965456|"     Efficacy and Safety of IDP-121 Lotion and IDP-121 Vehicle Lotion in the Treatment of Acne     Vulgaris   "
24464|NCT02965443|"     To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor     dapagliflozin + the DPP-4 inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a     BOT regimen in patients with type 2 diabetes.   "
24465|NCT02965430|"     This is an open-label, comparative, and prospective pivotal study to demonstrate that     AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic     fluid leakage rather than by urinary incontinence.      Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any     wetness.      The blinded physician will perform a diagnosis according to the standard diagnostic methods     (clinical assessment). The standard diagnostic methods will include the following tests: (1)     Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive     result in both the pH test and the Ferning test is defined as a positive clinical assessment.   "
24468|NCT02965391|"     Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden.     Circulating tumor DNA levels should decrease after complete surgery and could be increase as     tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung     cancer patients that no criterion has been established of how to use it for surveillance.   "
24469|NCT02965378|"     This phase II trial studies how well FGFR inhibitor AZD4547 (AZD4547) works in treating     patients with stage IV squamous cell lung cancer that has come back after previous treatment.     This is a sub-study that includes all screened patients positive for the fibroblast growth     factor receptor (FGFR) biomarker. FGFR can cause tumor cells to grow more quickly. AZD4547     may decrease the activity of FGFR and may be able to shrink tumors.   "
24472|NCT02965339|"     Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension,     atherosclerosis, dyslipidemia, chronic renal failure ...).      It is likely that a significant number of patients suffering from a preexisting endothelial     dysfunction. This endothelial dysfunction can be assessed by a molecular approach     (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal     circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as     ischemia-reperfusion injury is. No studies have evaluated the time course of the     infringement, and its association with the immediate post-operative complications (SIRS,     coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association     between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac     surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association     between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal     failure. Thus there is some data in the literature to suggest that the occurrence of     postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory     failure vasoplegic and acute renal failure) may result from the interaction between a     pre-existing endothelial dysfunction and operative aggression (extracorporeal circulation).     The onset of complications result from an interaction that depends on the importance of     endothelial dysfunction at baseline.   "
24473|NCT02965326|"     The purpose of this study is to determine which biological marker, or association of     biological markers, best predict clinical response of cystic fibrosis patients to CFTR     modulators.   "
24474|NCT02965313|"     This is a Canadian, multi-centre, double-blind randomized controlled trial of an innovative     vaginal surgery technique for correction of pelvic organ prolapse (POP) in women. Vaginal     surgery is preferred as minimally invasive, however the investigators do not know if     materials such as synthetic polypropylene mesh improve success, durability and     cost-effectiveness long-term. The investigators principal goal is to compare the experimental     bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M) to the     current standard of sacrospinous ligament suspension with synthetic sutures (SSLS) over a     timeline of 2 years. Patients and evaluators will be blind to technique.   "
24475|NCT02965300|"     The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath     of pulmonary lesion patients and healthy controls, in order to find the difference of     composition and concentration among groups.   "
24476|NCT02965287|"     The investigators have developed a diagnostic test for the evaluation of the presence of     fetal malformations through metabolomic analysis of maternal peripheral blood serum by     chromatographic techniques and mass spectrometry, and subsequent mathematical modeling     analysis of the data by means of multivariate mathematical models specifically developed for     this purpose. The study aims at determining the performance parameters (specificity,     sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the     test and its applicability. To do this, the investigators will use the serum samples of the     patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international     study conducted between years 2004-2008.   "
24477|NCT02965274|"     Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and     Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated     by a washout period of 35 days.   "
24478|NCT02965261|"     Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and     Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated     by a washout period of 35 days.   "
24479|NCT02965248|"     This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic     intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in     locally advanced colorectal cancer   "
24480|NCT02965235|"     Postoperative cognitive dysfunction (POCD) is a subtle cognitive dysfunction, especially     postoperative memory impairment lasting for weeks or months. The underlying     pathophysiological mechanism of POCD remain unclear. The aim of this study is to explore the     epigenetic changes during perioperative period and its correlation with POCD in surgical     patients.   "
24481|NCT02965222|"     To establish embryo time-difference kinetics scoring model for embryo selection before embryo     transfer. It is especially suitable for selective single embryo transfer, advanced infertile     women, and patients with repeated transplant failure. It can effectively improve clinical     pregnancy rate, improve embryo implantation rate and Rate of return home. Reduce the risk of     multiple pregnancies.   "
24482|NCT02965209|"     The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which     offers all of the advantageous options of spiral enteroscopy with a faster and less invasive     approach. The system is similar to other currently marketed endoscopes in that it     incorporates a flexible insertion tube, light source, digital imaging, and channels for     passing accessories for sample collection or therapeutic interventions. The NMSE system is     unique in that it incorporates a user-controlled motor contained in the endoscope's handle to     rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which     has soft spiral-shaped fins, pleats the small bowel on to the endoscope's insertion tube,     thereby allowing rapid and atraumatic access deep into the small bowel. The system also     includes a display monitor, a motor control unit, device to display measured motor current     and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and     limitation of rotation to a short cuff instead of a long overtube promise to accelerate the     procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to     conventional spiral enteroscopy   "
24485|NCT02965170|"     Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels     (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this     newly developed test will be compared to Tysabri® serum levels measured in parallel using an     independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®,     receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri®     serum levels.   "
24486|NCT02965157|"     Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and     efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting     antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28.     Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior     to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell     infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of     CAR T cells and efficacy.   "
24487|NCT02965144|"     This study builds on the limited body of existing literature combined with the results from     the investigators' previous research conducted with 30 newly diagnosed patients with     high-grade glioma (HGG) and 33 of their caregivers. This research established an overview of     the daily life experiences when diagnosed with a HGG or being a caregiver. Descriptions of     needs and preferences from time of diagnosis to one year exist. However, such data are still     lacking the representation from long-term survivors (LTS) and their caregivers.      This mixed methods study aims to address perspectives on daily life experiences of long-term     survivors with HGG and their caregivers as well as the needs and preferences for support,     rehabilitation and palliation.      Separate telephone interviews with patients and their caregivers and self-reported     questionnaires for patients will be conducted. The mixed methods design is a convergent     sequential design using an identical sampling.   "
24488|NCT02965131|"     This study aims to investigate the effects of the anhepatic phase extended by temporary     portocaval shunt on the sensitivity to desflurane administered at 0.6 age-adjusted minimum     alveolar concentration and its associative postoperative cognitive function.   "
24489|NCT02965118|"     This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic     Dermatitis patients.   "
24490|NCT02965105|"     The aim of the study is to test the performance and safety of a newly developed intermittent     catheter   "
24491|NCT02965092|"     Chimeric antigen receptor (CAR) consists of single chain variable fragment (scFv) and     activation domain of T cell, and CAR-modified T cells (CAR-T cells) have the capabilities to     recognize tumor associated antigen and kill tumor cells specifically. To a large part of     patients with refractory or relapsed B cell malignancies, CAR-T cell adoptive immunotherapy     can play a revolutionary effect in the field of cancer treatment. The investigators believe     that the cells with CD137 will have a better chance of killing the leukemia cells. In the     lab, the investigators constructed a second generation CAR containing CD137. The     investigators start Phase I study aimed to relapsed or refractory B cell malignancies. The     purpose of this study is to evaluate the safety and effectiveness of CD19 CAR-T cells in     patients.   "
24492|NCT02965079|"     Investigators will aim to conduct an observational study in order to assess very thoroughly     all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care     units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).      Secondary objectives will be:        1. to assess efficacy and safety of ECCO2R,        2. to compare the data issue from the registry to others studies assessing the same          population and to other centers and        3. to compare the different ECCOR devices in terms of efficacy and adverse events.   "
24493|NCT02965066|"     The aim of the study is to test the performance and safety of a newly developed intermittent     catheter in healthy volunteers.   "
24494|NCT02965053|"     This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and     Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of     EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving     hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are     identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789     and its combination with sevelamer carbonate are tested in Period 1 and Period 2     respectively.   "
24495|NCT02965040|"     For subjects with normal renal function or severely impaired renal function, this study will     evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine.      For subjects with end stage renal disease (ESRD) on continuous ambulatory peritoneal dialysis     (CAPD) or automated peritoneal dialysis (APD), this study will evaluate the pharmacokinetics     of roxadustat and its main metabolites in plasma, urine and dialysate.      For subjects with ESRD on hemodialysis (HD) or hemodiafiltration (HDF), this study will     evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and     dialysate and also the effect of dialysis on the pharmacokinetics of roxadustat and its main     metabolites.   "
24496|NCT02965027|"     Mild traumatic brain injury (mTBI) caused by blast effects of explosive devices has been     called the signature injury of soldiers who served in the Iraq and Afghanistan conflicts.     mTBI can also occur from impact or hitting the head on an object or the ground. Although     termed mild in comparison to major brain injuries, people with mTBI can have problems with     their memory and concentration. People with mTBI can also find they are more irritable, have     more anxiety, and have trouble with their mood and sleep.      The purpose of this study is to see if a medication called prazosin can help treat chronic     headaches in people with mTBI. The Food and Drug Administration (FDA) has approved prazosin     for treating people with high blood pressure. At this time, the FDA has not approved prazosin     in the treatment of mTBI or headaches. Some people who have posttraumatic stress disorder     (PTSD) and have been taking prazosin for their medical conditions or who have taken it in     research studies have said they have fewer headaches.   "
24535|NCT02964520|"     This study evaluates if individuals with moderate to high trait anxiety can learn how to     self-regulate their brain waves and reduce their trait anxiety in ten sessions of EEG     alpha-theta neurofeedback training. Half of the randomly assigned participants will receive     alpha/theta neurofeedback training while the other half will receive a two-part control     protocol where low beta and beta waves will be uptrained in and downtrained in in successive     sessions.   "
24497|NCT02965014|"     This three-arm cluster randomized trial will develop, test, and compare the efficacy of two     delivery formats of the Women's CoOp (WC), which is designed to provide risk reduction and     empowerment skills, as well as linkages to healthcare services for substance-using women. The     current study will develop a revised version of the WC and evaluate the relative efficacy of     a face-to-face (face-to-face WC), mobile Health application (mHealth WC) delivery format, and     HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors, reduce     substance use, and increase linkages to care among young (18-25 years) substance - using     African American women who are sexually active and have not recently been tested for HIV in     three NC counties.   "
24516|NCT02964767|"     A cross sectional study would be done for prevalence of HIV-Tb. co infection among patients     of HIV enrolled at ART centre, Khagaria, India, during June' 2015 to May' 2016. A comparative     study of CD4 (cluster of differentiation 4) T cell count among HIV-Tb. co infected patient     and HIV patients would be taken in account.   "
24498|NCT02965001|"     Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there     has been made substantial improvements in diagnosis, staging and treatment of HNC. The     overall survival has improved, but for some subgroups it is unchanged and therefore new     prognostic and surveillance methods are warranted.      One of the hallmarks in cancer is the ability to invade the surrounding tissue and     metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA)     and its receptor (uPAR) are present at the very front of the invasive tumor and they are     considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer     offers a very promising target for functional PET imaging and may be a stronger prognostic     marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to     patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx     and oral cavity, who are referred to curative intended radiotherapy. In this project all     participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy     and the prognostic efficacy is determined by assessment of the recurrence rate and mortality     at routine clinical follow-up.   "
24499|NCT02964988|"     The purpose of this study is to investigate the applicability of urokinase plasminogen     activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in     patients with metastatic castration-resistant prostate cancer (mCRPC)   "
24500|NCT02964975|"     Several meta analysis comparing successful Percutaneous Coronary Intervention of Chronic     Total Occlusion (PCI-CTO) with unsuccessful PCI-CTO showed that there is significant     reduction in short-term and long-term mortality. To our knowledge till today no prospective     randomized trial compared percutaneous revascularization of CTO with optimal medical therapy.     For this reason quality of live improvement is one of the most important indications for     revascularization in elective patients with CTO. In contemporary literature Seattle Angina     Questionnaire (SAQ) is a psychometrically solid disease-specific instrument designed to     assess the functional status of patients with angina. It comprises 19 questions that quantify     five clinically relevant domains: physical limitation, angina stability, angina frequency,     treatment satisfaction and disease perception/quality of life.      In this open prospective study patients with CTO of coronary artery will be randomized in two     groups: first - patients with percutaneous coronary intervention of chronic total occlusion     with optimal medical therapy and second group - patients with only optimal medical therapy     (control group). Primary endpoint will be quality of life and secondary endpoints will be     mayor adverse cardiovascular events (MACE). All patients will complete Seattle Angina     Questionnaire before randomization and after 6 months of follow-up.   "
24501|NCT02964962|"     The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the     29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in     symptomatic subjects with calcific, severe native aortic stenosis who are considered at     extreme or high risk for surgical aortic valve replacement (SAVR).   "
24502|NCT02964949|"     Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically     and irregularly, out of coordination with the two lower chambers (called ventricles) of the     heart. This can lead to blood clots forming in the heart chamber.      Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for     up to 12 months, with a 2-4 week follow-up, after which their participation is complete.      Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30,     90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).   "
24503|NCT02964936|"     The objective of this study is to evaluate the efficacy and the safety when ASP1517 is     intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis     chronic kidney disease patients with anemia.   "
24504|NCT02964923|"     The purpose of the study is to investigate these effects of Second-Generation Antipsychotic     (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore     the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous     Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic     disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine,     risperidone or ziprasidone).   "
24505|NCT02964910|"     This phase IV clinical study was designed to evaluate the immunogenicity and safety of the     recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,     in the chronic Hepatitis B patients on the clinical stability and aged over 30 years of age     at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered     intramuscularly according to a 0-1-6 month schedule.   "
24506|NCT02964897|"     Veterans leaving incarceration and re-entering their communities (often described as     reentry Veterans) face a number of challenges, including uncertainty about housing,     vulnerability to substance use and relapse, on-going mental health concerns, and often     multiple health conditions require timely continuity of care. The purpose of the project is     to increase support for Veterans post-incarceration through the addition of trained peers     with lived experience of being a Veteran and a history of incarceration. Emphasis will be on     peers who will help link Veterans to Veterans Health Administration (VHA) services, including     housing and healthcare. Peers will provide linkage with Health Care Reentry Veterans program     specialists, transportation to appointments, and support in community reintegration. Peers     will assist reentry veterans to make a successful transition and get and stay engaged in     their care.   "
24507|NCT02964884|"     Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four     times greater risk of learning disabilities, including reading disabilities, and a deficiency     of neurofibromin - a protein important in a signaling pathway that regulates learning and     memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can     respond to standard phonologically-based reading tutoring originally developed to treat     reading disability in the general population. Combining our work with that by other     researchers suggesting that a medication (Lovastatin) may counteract the effects of the     deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the     investigator propose to examine the synergistic effects of medication plus reading tutoring.   "
24517|NCT02964754|"     To verify whether digital three-dimensional model-assisted internal fixation can obtain     better effects in the repair of complex long bone fractures compared with conventional     internal fixation.   "
24508|NCT02964871|"     RAPID-LTCF is a stratified, block-randomized controlled trial to assess the effectiveness of     a simple ARI case definition, rapid influenza diagnostic test (RIDT) with wireless     transmission of results, and provision of infection control guidance when influenza is     detected. Because of the nature of the intervention, blinding is not possible. Sites will be     initially recruited for a study of respiratory infections within LTCFs. After acceptance     into the study, sites will be matched in terms of bed capacity, location, and other features     prior to randomization.   "
24509|NCT02964858|"     The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25     fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36     Gy in 20 fractions.      The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing     improvement in overall survival and progression free survival with combined modality     treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55     Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive     lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of     higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid     abnormalities and secondary breast cancer are being increasingly identified. Hence it is     essential to optimize the dose of radiotherapy for lower toxicity without compromising on     efficacy.   "
24510|NCT02964845|"     Women recently released (RR women) from incarceration constitute a vulnerable group     characterized by high rates of untreated HIV and sexually transmitted infections (STIs),     substance use disorder (SUD), mental health (MH) disorders and trauma. This interconnected     syndemic requires helping RR women to overcome multiple internal and structural care     barriers. This R34 builds on work conducted by the PI in a NIDA-funded K23 project, in which     an intervention called Women's Initiative Supporting Health (WISH) was developed to improve     RR women's engagement in HIV, Hepatitis C (HCV), and primary medical care using Self     Determination Theory (SDT). The proposed R34 project, a natural extension of this prior work,     will conduct a pilot randomized controlled trial (RCT) of the WISH intervention to examine     feasibility, acceptability, and preliminary effectiveness.   "
24511|NCT02964832|"     To improve the quality of CPR education, we want to assess the validity and reliability of     the feedback depth measured by smartphone applications according to the smartphone attachment     sites as an educational tool. However, in the prior study, armband method showed     overestimated chest compression depth. The reason of the overestimation was analyzed that the     weight of the smartphone amplified the inertial force to produce additional linear movement.     In this study, we will make new device to fix the smartphone on the arm and on the hand and     compare the chest compression depth between CPR manikin and smartphone application.   "
24512|NCT02964819|"     This project will analyze the influence of interferential current therapy in an exercise     program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers     of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with     more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment,     positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into     the following groups: exercise group, exercise + ultrasound group, exercise group +     interferential current. Sixteen consecutive treatment sessions will be performed, and the     volunteers will be evaluated before and after, by means of the following instruments:     Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI),     Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation     of pain at the end of Each session and one month after the end of treatment.   "
24513|NCT02964806|"     Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary     surgery contribute impaired nutritional status in postoperative period. It can also affect     perioperative and oncologic outcomes negatively. Therefore it is important to improve     nutritional status in postoperative period by supply tailor-made optimal diets. The     investigators have developed customized postoperative diets for pancreaticobiliary cancer     patients. The investigators expect that customized diets for pancreaticobiliary patients will     increase the food intake rate and contribute a improvement of perioperative outcomes and even     oncologic outcomes.   "
24514|NCT02964793|"     Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and     policy makers, and a central question is how to improve the performance of screening during     pregnancy in order to provide appropriate care. The recent recommendations and reporting of     French results have raised awareness of the need to improve growth screening in France. Based     on the existing literature, the hypothesis is that a greater investment in growth monitoring     based on a more rigorous interpretation of information available from routinely implemented     clinical assessment and ultrasound will allow for significant gains in detection. The current     context provides the opportunity to evaluate the application of a training program for serial     plotting of Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) on customised     charts. This intervention is consistent with French guidelines which support the monthly     measurement of SFH, the use of Customised Fetal Weight Reference (CFWR), in particular for     referral US (Ultrasound) examinations, and the longitudinal interpretation of growth. These     guidelines were recently restated in the clinical practice recommendations issued by the     French College of Obstetricians and Gynecologists.      The intervention tested in the trial will include training of professionals for     standardization of SFH measurement, introduction of software, and recommendations for growth     interpretation and referral examinations. Expected benefits are an increase in antenatal     identification of growth restricted fetuses without an increase in the FP rate. Such a     program will allow identified Small for Gestational Age (SGA) fetuses to receive appropriate     antenatal care. This intervention could double the detection rate of SGA births from 20 to     40%, corresponding to 32 000 infants nationwide annually for whom antenatal care could be     improved.      Main objective: To test the effectiveness of the serial plotting of SFH and EFW measures on     customised percentile charts supported by provider training, versus standard antenatal care,     to improve the detection of FGR. The aim of the investigators is to double rates of antenatal     detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th     percentile for GA.   "
24515|NCT02964780|"     The main objective of the study is to gain insight in the early dynamics and mechanisms of     recovery of liver disease and sex steroid metabolism during weight loss in obese men and     women and to investigate whether surgical weight loss has differential effects as compared to     weight loss with life style measures. In addition, we want to evaluate the postprandial     hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.      Secondary objectives are investigating determinants for the changes in sex steroids, liver     disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion     patterns, body composition, resting metabolism rate, weight loss per se and changes in fat     distribution, parameters of fatty acid metabolism, … .   "
24958|NCT02958995|"     The purpose of this study was to evaluate whether treatment with pioglitazone is associated     with risk of incident cancer at the 10 most common sites in a cohort of participants with     recognized diabetes along with the assessment of association between diabetes severity and     cancer risk.   "
24518|NCT02964741|"     This study investigates whether non-invasive brain stimulation, given for 20 minutes/once per     day for ten days (M-F) can reduce migraine pain. Thirty patients will receive this treatment,     while thirty will receive a sham procedure. Up to thirty healthy volunteers will be asked     to undergo baseline assessments only (imaging, but no brain stimulation). Healthy volunteer     data may be used from a prior study (NINDS-K23062946 project [IRBMED #HUM00027383; Dr.     Alexandre DaSilva, Principal Investigator]).   "
24519|NCT02964728|"     The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4     patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds     of the tongue and the lower lip for at least 6 months, refractory to common pharmacological     treatments. Pain severity will be measured by the visual analog scale (VAS) indicating     average week pain before injection. Each patient will be injected with a total dose of 16     units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and     4 units into each antero-lateral side of the tongue. In order to determine if a placebo     effect may be involved, we will inject 2 additional patients with saline solution using the     same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at     4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated     after 4 weeks with incobotulinumA with the same dose reported above.   "
24520|NCT02964715|"     Non-Alcoholic Fatty Liver Disease( NAFLD) is common in patients with type 2 diabetes.     Empagliflozin, an FDA-approved oral medication used to treat type 2 diabetes, has been shown     to reduce production and deposition of fat in the liver in animal experiments. There is     little published evidence that this is so in Asian patients with type 2 diabetes. The     investigators designed this pilot study to determine if use of empagliflozin for 6 months in     patients with type 2 diabetes can improve scan, blood marker and biopsy features of NAFLD.   "
24521|NCT02964702|"     To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by     removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction     (within 8 hours after onset), in whom intravenous administration of tissue plasminogen     activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA     administration.   "
24522|NCT02964689|"     The aim is to determine the recommended phase 2 dose (RP2D) of binimetinib in combination     with pemetrexed and cisplatin, and to demonstrate that the combination is feasible and has     preliminary activity in previously untreated patients with advanced NSCLC and documented KRAS     mutations.   "
24523|NCT02964676|"     To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number     of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in     Chinese PACG .   "
24524|NCT02964663|"     The purpose of this study was to compare CO measured by two easy to use non-invasive     monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences,     Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery.   "
24525|NCT02964650|"     The investigators have demonstrated that they can reliably identify an optimum heart rate     range for contractility of the left ventricle in patients with chronic heart failure (CHF).     They have also demonstrated in an acute cross-over study that keeping the heart rate in this     range (versus standard rate-response programming) in patients with CHF is associated with     increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a     randomised, placebo-controlled trial whether optimal programming versus standard     rate-response programming for 6 months leads to appreciable improvements in exercise time and     quality of life, while having no adverse effects on left ventricular function and battery     longevity.      60 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic     assessment to establish the force frequency relationship and the optimal heart rate for     contractility. They will then perform a treadmill walk test and fill out a quality of life     questionnaire. They will then be randomised to optimal rate-response settings or standard     rate response settings and followed up at 6 months at which point the tests will be repeated.   "
24526|NCT02964637|"     To establish diagnostic tools to make an accurate clinical and pathological diagnosis of     patients with clinical FTLD syndromes   "
24537|NCT02964494|"     The investigators propose the creation and maintenance of a comprehensive registry for     patients with the diagnosis of Congenital Dyserythropoietic Anemia (CDA) in North America.     The goal of this registry will be to collect long-term confidential data on patients with CDA     in the US, Canada, and Mexico and create a bio-repository of de-identified patient blood and     bone marrow specimens as a tool for the investigation of epidemiology, natural history,     biology, and molecular pathogenetic mechanisms of CDA.   "
24539|NCT02964468|"     The aim of this study is to evaluate the increase of radiation dose administered in patients     diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using     IMRT (concomitant boost technique).   "
24540|NCT02964455|"     The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of     docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest     radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.   "
25353|NCT02953821|"     Subjects with active systemic lupus erythematosus (SLE) will be randomized to receive Acthar     or placebo. Active treatment will continue for 24 weeks. Efficacy will be assessed at     multiple timepoints using the SLE Responder Index (SRI), SLEDAI-2K, BILAG, PGA, CLASI and 28     Joint Count   "
24527|NCT02964624|"     Osteoarthritis (OA) is the most common type of degenerative joint disease. Furthermore,     despite its incidence being amongst the highest in chronic diseases, effective biomarkers,     diagnostic aids and imaging technology are not available to assist in the management of OA.     Mounting evidence suggests that non-pharmacological treatment such as exercise/physical     therapy may lower the risk for onset or progression of OA by mitigating inflammation.     However, the mechanical unloading and overloading, as seen in disuse and overuse, lead to     upregulation of several proinflammatory molecules and enhance tissue degradation, whereas,     dynamic moderate mechanical loading exerts anti-inflammatory and anti-catabolic effects on     articular cartilage by suppressing mediators of inflammation. However, the lack of robust     biomarkers to measure the effectiveness of physical therapies, represent a critical gap in     biotechnology, obliterating the progress in the optimal application of these therapies. Our     central hypothesis is that the circulating levels of specific molecules could serve as robust     biomarkers for quantitative measures of OA burden, prognosis, progression or treatment     efficacy. The objective of this project is to identify and evaluate mediators that serve as     biomarkers of OA progression and treatment. Recently, high mobility group box chromosomal     protein 1 (HMGB-1) has been suggested to be markedly upregulated in OA. However, presently     there are no inhibitors of HMGB1 that could be used therapeutically. Previous results showed     that that gentle exercise is the only tool that can mitigate HMGB1 production by local and     systemic macrophages, and thus inflammation. Serum concentration of HMGB1 will be evaluate as     a biomarker in OA patients and relate it to the functional capacity of knee joints in OA     patients after rehabilitation protocol (RP). The RP will consist of three rehabilitation     session/week during eight weeks. The efficacy of a RP will be evaluated by functional scale     Western Ontario & McMaster Universities Osteoarthritis (WOMAC), Scale for the measurement of     health related quality of life using EuroQol five dimensions questionnaire (EuroQOL-5D),     Visual Analog Scale (VAS), and physical function tests. Besides all clinical assessment,     serum levels of classical pro-inflammatory cytokines, hyaluronan and HMGB1 will be evaluated.     A correlation of physical improvement after RP and serum biomarkers will be performed.   "
24528|NCT02964611|"     The aim of this study is to compare personality and social cognition changes, including     emotion detection and self-awareness, and neuroanatomical correlates in patients, and how     that affects the caregiver-patient relationship.   "
24541|NCT02964442|"     Brown adipose tissue (BAT) thermogenesis can be assessed by IR thermography, the accompanying     increase metabolic rate can be measured by whole body calorimetry and BAT volume can be     precisely measured by MRI. The aim of the study is to validate IRT for BAT thermogenesis     against the present gold standard 18-FDG-PET scan, quantify BAT volume by fat fraction MRI     and measure the accompanying increase in BMR by whole body calorimetry among healthy     euthyroid subjects.   "
24542|NCT02964429|"     The main purpose of this study is the determination of the in-vivo ultrafiltration     coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in     the United States.   "
24529|NCT02964598|"     Adolescence associates with alterations in sleep-wake organization, such as later circadian     phase preference. Simultaneously external pressures, such as evening-driven social activities     increase. These may lead to delayed sleep phase, which may cause serious problems for waking     up at socially accepted times, and absenteeism from the school may follow. This project aims     at tracking risk factors for later circadian regulation problems, characterizing     interconnections of biological, psychological and behavioural mechanisms that maintain or     induce poor sleep regulation in adolescence, and building a cost-effective,     theoretically-based sleep intervention for adolescents with delayed sleep phase. This     randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.   "
24530|NCT02964585|"     The investigators hypothesize that Cana may be able to improve number and function of CD34+     endothelial progenitor cells. The investigators also propose that this expected     cardiovascular benefit is independent of HbA1C reduction.      In this proposed study the investigators plan to recruit patients with type 2 diabetes of     less than or equal to 15 years duration (in early phase of diagnosis), who are on a stable     dose of metformin for at least 3 months but still remain inadequately controlled with HbA1C     between 7% and 10% (both values inclusive), but not overtly out of control (> 10% of HbA1C).      Subjects will begin taking 100 mg of Cana or placebo after initial 4 weeks. Subjects will be     withdrawn from the study if the medication or placebo is not tolerated.   "
24531|NCT02964572|"     -  Single-center, prospective, active-controlled, open, randomized, 2 arm parallel,          interventional, exploratory pilot        -  Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic          control with metformin-based oral hypoglycemic agents will be prescribed glimepiride          (comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days) as          add-on therapy        -  Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3          inflammasome activity from baseline to final timepoint will be assessed.   "
24532|NCT02964559|"     This phase II trial studies how well pembrolizumab works in treating patients with skin     cancer that has spread from where it started to nearby tissue, lymph nodes, or other parts of     the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of     tumor cells to grow and spread.   "
24533|NCT02964546|"     Atrial fibrillation in the elderly is a complex condition due to the high number of     frequently associated comorbidities such kidney disease. Direct oral anticoagulants     (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but     renal function should be closely monitored for this age group when these drugs are used.     Dosing recommendations for prevention of stroke are based on renal clearance of creatinine     (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates     predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates.     This raises the possibility that substitution of commonly reported GFR for estimated CrCl     could result in different plasmatic concentrations of oral direct anticoagulants. The aim of     this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic     concentration of these drugs in elderly patients with non-valvular atrial fibrillation.   "
24534|NCT02964533|"     Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire     moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect     and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a     randomized controlled trial by recruiting chronic fatigue syndrome patient as subject,     applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick     moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as     evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there     are totally 15 sessions.   "
24600|NCT02963675|"     This study is conducted to obtain information about prostate cancer patients with bone     metastases before the end of 2013. The incidence of second primary malignancies and overall     survival in patients with castration resistant prostate cancer are of particular interest.     Information from this study will serve as a historical reference for the REASSURE study     (Background incidence study)   "
24543|NCT02964416|"     Several modalities have been studied to prevent coughing during emergence, including     extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no     reliable method is recommended as standard of care. The advantages of administering tramadol     includes a long duration of action, rapid recovery, limited depression of respiratory     function and no effect on platelet makes it a safe medication to use for neurosurgical     patients after craniotomy. The primary objective of the study is to observe the effect of     single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic     response (measurement of B.P and H.R) during extubation.   "
24544|NCT02964403|"     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in     high risk patients was considered a standard method to prevent PEP. The mechanism of     indomethacin is dependent on COX-2 inhibitor.      According to data, we design the project. The purpose of this study is to determine whether     COX-2 inhibitor is effective on control of Post-ERCP pancreatitis.   "
24545|NCT02964390|"     Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option for     non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).      The aim of this study was to evaluate the safety and efficacy of BPA in patients disqualified     from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.      This is a interventional study analyzing the benefits and the risk of BPA. Clinical     evaluation, including: functional capacity, 6-minutes walking test, haemodynamics,     biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL     assessment with Short Form 36 (SF36) questionnaire was performed before the initiation     therapy of BPA, and 3-6 months after last session of BPA.   "
24546|NCT02964377|"     This single center open-label pilot study will enroll 15 non-ambulatory children with     Duchenne muscular dystrophy at least 8 years of age and who demonstrate pre-clinical     cardiomyopathy (defined as a cardiac ejection fraction >55% with abnormal LV strain by     cardiac MRI). They will receive (+)-epicatechin at one of three doses during an 8-week     dose-ranging study with assessments at baseline, 2 Weeks, 4weeks, and 8 weeks. The study will     determine optimal dosing for future cardiac efficacy studies based on serum / plasma     biomarker response using follistatin: myostatin ratio, nitrite/nitrate ratio, cardiac     troponins and cardiac BNP. Secondary endpoints will include additional biomarker assessments     by SOMAscanTM, cardiac functional evaluations by cardiac MRI (LV strain), and echocardiogram     (LV strain by speckle tracking) and measures of strength, range of motion and mobility, and     clinical safety assessments. Results of secondary endpoint analysis will be used to refine     design of subsequent clinical trials powered to detect changes in clinical outcomes.   "
24547|NCT02964364|"     Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta     and its major branches. The epidemiology and pathophysiology of TA is still unclear in China,     although many studies have been done. Our previous study supporting by National Natural     Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor     necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were     associated with TA in Chinese han population. Further investigations with larger samples are     needed to fully understand the a pathophysiology of TA. The purpose of this study is to build     a Chinese national registry system for TA to obtain real-world information, such as current     status of characteristics, diagnosis, disease activity, the severity of disease, treatment     and outcomes of Chinese TA patients. To analysis and development of effective disease     monitoring and treatment strategies.   "
24548|NCT02964351|"     In our study, the investigators want to find correlation between circulating miRNAs     associated with prostate cancer metastases to bones and to lymph nodes separately with     results of 68Ga-PSMA ligand PET (positron emission computed) imaging.   "
24549|NCT02964338|"     The purpose of the current study is to evaluate the efficacy and safety of TEV-48125     (Fremanezumab), in the prevention of CCH in adult patients.   "
24551|NCT02964312|"     To obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing     placement of the Spirox Latera Implant with or without concurrent turbinate reduction     procedures in an office setting.   "
24552|NCT02964299|"     The purpose of this study is to compare the effect of mandibular advancement bite block to     standard bite block for prevention of hypoxemia, intervention events and adverse effects     during endoscopic examinations.   "
24553|NCT02964286|"     In this proposed project, the investigator will estimate the effect of massotherapy of     acupoints on alleviating chemotherapy-induced myelosuppression among patients with cancer.   "
24554|NCT02964273|"     The primary objective of the study is to assess the long term safety of treatment with     tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease     (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and     efficacy of tolvaptan in the same subject population.   "
24555|NCT02964260|"     This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE)     simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half     participants will receive TAE simultaneously combined with thermal ablation and the other     half receive TACE sequentially combined with thermal ablation, which is a conventional     treatment for HCC patients.   "
24556|NCT02964247|"     The trial is conducted in Asia, Europe, North America and South America. The aim of the study     is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2     inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes     mellitus.   "
24597|NCT02963714|"     Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a     four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates     are inadequate and persistence of immunity remains a challenge.      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune     persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three     injections at months 0, 1, and 6 in hemodialysis patients.   "
24683|NCT02962596|"     This research is targeting patients with sonographically indeterminate adnexal mass that are     being referred for clinical MR imaging. Investigators from the UW will be contributing coded     MR images and associated health information (US results, laboratory/pathology results) to the     EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the     research.   "
24557|NCT02964234|"     The participatory-based project will quantify the 'added benefit' of an empowerment     intervention relative to an education intervention for 150 Latinas on the following outcomes:     women's adherence to breast cancer screening guidelines; women's psychosocial facilitators     (self-efficacy, norms, support, and knowledge); and women's dissemination of breast health     messages throughout their social network. The empowerment intervention will train Latinas in     how to discuss breast health with their family and friends and volunteer in local breast     health promotion programs. Academic, clinician, and community partners will work together     throughout intervention development and evaluation.   "
24558|NCT02964221|"     Patients assume that cognitive performance rapidly returns to baseline after anesthesia and     surgery. Several studies have shown that one week after major non-cardiac surgery about 27%     of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months.     Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly     reduces quality of life. Identifying risk factors for POCD is important because it is     associated with prolonged hospital stay, loss of independence, and premature retirement.     There is an urgent need to measure and document the level of cognitive change associated with     surgery with an easy to use tool, both prior to admission and after discharge. This     information can be used to plan appropriate care paths and to identify or test the efficacy     of potential new treatments to alter the negative trajectory.   "
24559|NCT02964208|"     The AMPLATZER LAA Occluder is a transcatheter, self-expanding nitinol device intended for use     in preventing thrombus embolization from the LAA. The purpose of this study is to compile     real world outcome data on the use of AMPLATZER LAA Occluder in subjects with non-valvular     atrial fibrillation (NVAF)   "
24560|NCT02964195|"     The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of     cirrhotic gastroesophageal variceal bleeding.   "
24561|NCT02964182|"     The goal of this research study is to learn more about the effects of different nicotine     levels in cigarettes and electronic cigarettes (e-cigarettes). E-cigarettes use water vapor     to deliver nicotine.   "
24562|NCT02964169|"     Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's     health through family planning choices, regular health reviews, and support. A cohort study     that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women     having no desire for a (another) child during the 4 years since ART initiation, 51% had a     serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of     contraceptive use were family planning goals within the DYAD. One of the key predictors of     effective contraceptive use was male partner involvement and CD4 count. The WHO recommends     dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV     transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at     providing information on whether continuous family planning accessibility and support has a     measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV     positive mothers delivering at MRRH, SW Uganda.   "
24563|NCT02964156|"     50-90% of patients with RA reports foot problems and the metatarsophalangeal joints of the     forefoot are most frequently afflicted. Studies shows that foot problems can influence     negatively on the walking function, physical activity and quality of life. Different foot     orthoses and insoles are used as an intervention. Studies find that different insoles do have     effect on pain, but there are no or minor effect on walking ability. The literature reports a     further need for research and indicates the importance of studies on the effects of     cost-effective insoles for patients with RA.      Custom-built insoles takes time and are often expensive, and many patients, especially women,     do not wear them since they often do not fit the shoes they prefer to wear. In this study, a     4-mm thin, flat insole of a malleable plastic material (CI-Core®) with synthetic textile     material on the upper side is customized to provide support for the transverse and     longitudinal arches of the foot to reduce pressure on painful joints. The insole is easily     customized and ready for use the same day. The purpose of this study was to determine whether     this insole can reduce foot pain and increase walking distance in patients with RA and     forefoot pain.      An experimental study was performed on patients with RA and forefoot pain in either one or     both feet. The patients walked as fast as they could in 6 minutes (6MWT) with either insoles     (situation A) and without insoles (situation B). The order of situation A and B was     randomized, and the assessor was blinded for the order of the two situations. Both tests were     conducted the same day. After each test round, the patient was asked to register pain in the     foot and perceived exertion. A telephone interview was conducted one year after the effect     study to examine whether the insoles were still being used.   "
24564|NCT02964143|"     Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood,     representing a powerful source of platelet-derived growth factors, particularly useful in the     field of regenerative medicine. The active and sequential secretion of these growth factors     induces different cell signaling cascades that activate angiogenesis, cell proliferation,     cell differentiation, eventually leading to new matrix synthesis and tissue regeneration.      The potential benefits from the use of PRP for the treatment of cartilage defects rely on a     number of studies conducted in validated animal models or in vitro, demonstrating the ability     of PRP to stimulate collagen production and proteoglycans synthesis, as well as the     proliferation and differentiation of mesenchymal stem cells into chondrocytes. Additionally,     an increasing number of clinical studies shows an improvement of symptoms, most especially     pain, without any occurrence of serious adverse events.      Hyaluronic acid (HA), as one of the major components of the synovial fluid surrounding the     cartilage, assumes an important role in the viscoelastic properties of the articular     cartilage, conferring its shock absorbing and lubricating functions.      It was demonstrated that rheological properties of synovial fluid decrease with aging and in     patients suffering from osteoarthritis. Nowadays, intra-articular injections of hyaluronic     acid represent a well recommended therapeutic option to relieve osteoarthritic symptoms,     conferring a mechanical action on joints structures, thus leading to reduced pain and     improved joint function Based on these data, it seems reasonable to hypothesize that a     combination of both PRP and hyaluronic acid could provide greater benefits compared to the     administration of each product alone, as their effects on osteoarthritis improvement are     based on different mechanisms of action. In fact, on one side PRP promotes cartilage     regeneration, while on the other side the HA acts as 3-dimensional support mesh for PRP,     providing optimal release of platelets growth factors, strengthening and extending in time     the activity of PRP.      Cellular MatrixTM is a CE-marked class III medical device manufactured by the Swiss company     RegenLab SA. Cellular MatrixTM allows to prepare autologous PRP combined with a     non-crosslinked hyaluronic acid in a safe, rapid manner and in a single step. The PRP/HA     combination is intended to be injected intra-articularly, in order to relieve osteoarthritic     symptoms and to improve joint mobility and function. Therefore, the PRP/HA combination might     represent a novel therapeutic option for patient suffering from knee osteoarthritis.      This study will evaluate whether the effects of a PRP/HA combination prepared with Cellular     Matrix™, when injected intra-articularly for the treatment of mild to moderate knee     osteoarthritis, are superior to those of a well-recognized hyaluronic acid treatment     (Ostenil® Plus), on one hand, and to those of PRP alone, on the other hand.   "
46649|NCT02675023|"     This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg)     subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe     (PFS) in healthy subjects.   "
24565|NCT02964130|"     This pilot study is part of a global project that aims to better define and understand     features of FBSS/POPS post-operative persistent syndrome patients (shortened as FBSS in     the following project). FBSS is the acronym for Failed Back Surgery Syndrome, which has been     defined as a chronic condition resulting from spinal interventions. Despite anatomically     successful spine surgery, a significant proportion of patients is experiencing chronic     refractory back and leg pain. In a recent multicentre study conducted on more than 100     refractory FBSS patients, (ESTIMET Study), the mean delay between pain occurrence and FBSS     diagnosis was 5 years. Therefore, FBSS pattern and potential responder stratification might     guide us to eventually develop a decision tool for identifying FBSS patients. Easing and     helping diagnosis of FBSS should improve referral yield to specialists and accelerate patient     flow through the care pathway. Hence, FBSS patients, who usually present a long standing     history of pain, would have access to appropriate therapies earlier. This could lead to     better outcomes. The aim of this multicentre, prospective study is to collect specific data     that are not collected in routine in order to better define and understand the potential FBSS     population and to accelerate the diagnostic and optimize the choice of appropriate treatment.      A multidisciplinary approach through a pain management clinical network, as it has been     structured in Poitiers, will ensure that an exhaustive characterization of FBSS patients and     their care pathway will be collected. In addition, since the cooperation between orthopaedic     and neuro spine surgeons is not a common relationship found all over Europe (as it is     observed in Poitiers), this study also aims to better understand the development of     interactions between physicians/professionals and the substantial advantage which would     result from bridging this gap. The N3MT (NeuroMapping Tools) software developed in Poitiers     to collect data and assess objectively pain surface and intensity changes, before/after any     treatment, with quantitative measurements, will be used as the central key of this project.   "
24566|NCT02964117|"     Epidemiological investigations has suggested exposure to air pollution linked with     respiratory disease, especially chronic obstructive pulmonary disease. However, the potential     mechanisms of adverse effects remains scare. The present study will assess the association     between air pollutants and respiratory related parameters to elucidate possible mechanisms.   "
24567|NCT02964104|"     This trial is conducted in Europe. The aim of the trial is to investigate the safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects     with type 2 diabetes.   "
24568|NCT02964091|"     The main purpose of the study is to evaluate the efficacy, safety and tolerability of a     medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis     C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory     monitoring to determine the minimum laboratory tests necessary.   "
24569|NCT02964078|"     The main purpose of this study is to evaluate the effects of the interleukin-2 given in     combination with pembrolizumab.      Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™.      Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.   "
24570|NCT02964065|"     This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to     evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated     influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.   "
24571|NCT02964052|"     Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has     been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 -     70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile     recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of     comorbidity. In this regards, developing selection criteria using acute stroke imaging and     comorbidity is warranted.      Investigators will recruit the consecutive acute stroke patients who received IV thrombolysis     and/or IA recanalization treatment. This study will perform with prospective design to     develop CT-based clot, core and collateral scores and a comorbidity index for selecting     stroke patients who are at high risks by the treatment. Investigators will firstly establish     the CT-based scores and comorbidity index using a pre-existing cohort database. Using these     CT-based and comorbidity index, Investigators will validate them in a multi-center     prospectively cohort. In addition, Investigators will assess the cost-effectiveness of     selecting patients based on the comorbidity index.   "
24572|NCT02964039|"     The purpose of this study is to determine whether a novel treadmill training intervention can     improve the gait stabilization strategy used by individuals who have experienced a stroke.   "
24573|NCT02964026|"     The primary objective for this retrospective Electronic Health Record (EHR) analysis is to     evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter     (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated     coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex     nonvalvular procedures and heart transplants). The study will be conducted using     prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010     - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas     City, MO).   "
24575|NCT02964000|"     Hypothesis: Use of high level vs low level cold laser treatments will reduce chronic pain and     the need for PRN opioid-containing analgesic medications.      Secondary Hypothesis: High level (vs low level) laser treatments will increase the patients     level of physical activity and quality of sleep.   "
24576|NCT02963987|"     In this study, the investigators varied the portion size of all meals served during two 5-day     periods. During one period, baseline amounts of all foods and beverages were served, and     during the other, the portion size of all items was increased by 50%. The primary aim of the     study is to determine the effect of varying the portion size of foods and beverages served     over 5 days on energy intake in preschool children.   "
24577|NCT02963974|"     This feasibility study evaluates whether children with unilateral, moderate to profound     sensorineural hearing loss experience an improvement in speech perception, hearing in noise,     localization, and quality of life with a cochlear implant as compared to an unaided listening     condition.   "
24603|NCT02963636|"     The project objective is to evaluate the impact of the recent addition of pharmacists within     family medicine groups (FMGs) on organizational and clinical parameters. The process by which     changes occur and the level of pharmacists' activities will also be assessed. The ultimate     goal of the project is the development of an accompanying guide to facilitate the work of the     pharmacist in monitoring complex patients in primary care medical clinics.   "
24604|NCT02963623|"     Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in     total knee replacement patients.   "
25371|NCT02953574|"     The purpose of this study is to determine if the daily performance of a 7 step bedtime     nursing protocol for hospitalized people living with dementia is feasible and if it has an     effect on bedtime and daytime variables.   "
24578|NCT02963961|"     Postoperative delirium is a significant public health concern, affecting up to 70% of elderly     patients presenting for surgery. Furthermore, postoperative delirium is associated with     increased mortality, persistent cognitive decline, increased hospital length of stay, and     elevated healthcare costs. Unfortunately, there is a lack of evidence-based strategies that     consistently and effectively reduce the risk of delirium. In fact, although the American     Geriatrics Society has released guidelines for the prevention of postoperative delirium, the     evidence supporting many of the proposed preventive measures has been deemed low quality.      Cognitive training exercises have been shown to improve cognitive function and functional     status in community-dwelling elderly adults, and benefits may last for several months to     years. Specifically, training exercises have led to improved performance in attention,     short-term memory, and visuospatial processing; all of which are implicated as clinical     features of delirium. Cognitive training has also strengthened connectivity in brain networks     implicated in postoperative delirium. Thus, given these specific neurological benefits     afforded, preoperative cognitive training may provide protection against the development of     postoperative delirium. As such, the aim of this pilot study is to assess the feasibility of     implementing a preoperative cognitive training program for surgical patients at high-risk for     delirium and other associated complications.   "
24579|NCT02963948|"     This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and     utilizing the CDEs in clinical practice requires a strategy for implementing screening to     collect substance use information that populates the CDEs, and assisting primary care medical     staff to offer appropriate interventions by providing clinical decision support (CDS) and a     mechanism for making referrals to addiction treatment. Investigators aim to maximize the     efficient adoption of screening, CDS, and treatment referrals by integrating all of these     activities into the electronic health record (EHR).      The study will be conducted at three sites, representing three large health systems. Each     phase will include deliverables essential to move to the next phase, and an independent     Advisory Committee will review progress and make recommendations at each transition about how     best to progress to each subsequent phase. Based on progress during earlier phases, the     Advisory Committee may recommend expansion to additional clinics or health systems during the     second part of Phase 4.   "
24580|NCT02963935|"     This trial is conducted in the United States of America (USA). The purpose of the trial is to     investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour     therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for     obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS)     visit schedule).   "
24583|NCT02963896|"     Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including     postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom     postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular     symptoms postoperatively.   "
24584|NCT02963883|"     Postoperative erythrocytes transfusion is associated with morbidity and excess mortality,     which should lead to ask the indication for RBC transfusions only on metabolic needs.     Currently, the majority of studies used to put hemoglobin values indicating red cell     transfusions. Two observational studies have confirmed that a transfusion strategy based on a     metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than     using the hemoglobin threshold values. We propose to conduct the first randomized multicenter     study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the     ScvO2 each patient versus a threshold value usually recommended for all patients.   "
24598|NCT02963701|"     Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet     containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets     containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet     with respect to the analytes, ibuprofen and pseudoephedrine.      Secondary objective To assess the bioequivalence of a fixed dose combination tablet     containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets     containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet     with respect to R- and S-ibuprofen (enantiomers of ibuprofen).   "
24599|NCT02963688|"     PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2     mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial ovarian     cancer (EOC).      PATIENTS AND METHODS: In a nationwide case-control study on EOC conducted in Korea between     2010 and 2015, 298 Korean women with HG serous and/or endometrioid EOC were tested for gBRCA     1/2 mutation, regardless of the family history. Mutation screening was performed using the     Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) and Ion PGM platform     according to the manufacturer's instructions. Clinical characteristics including survival     outcome was assessed in gBRCAm carriers.   "
24970|NCT02958839|"     To investigate whether fibroblast growth factor 23 can be used to predict recurrence after     catheter ablation for atrial fibrillation and to provide an objective basis for the clinical     selection of the optimal patients for catheter ablation.   "
24601|NCT02963662|"     Obesity and type 2 diabetes, dyslipidemia and related metabolic disease has become a threat     to our national life and health which is showing a trend. Bariatric Surgery had been     confirmed definite therapeutic effect to obesity and type 2 diabetes. However, laparoscopic     gastric bypass and laparoscopic sleeve gastrectomy have the similar outcome to type 2     diabetes, but the two surgical methods and principles are completely different, which     mechanisms are not yet clear. Lots of literature report adipose tissue releases adipokines     and inflammatory cytokines induced chronic inflammation and obesity-related complications     (insulin resistance and Type 2 diabetes).It is not clear whether to change these     gastrointestinal hormones, adipokines and secretion of inflammatory cytokines with the     operation, which play a therapeutic effect of obesity-related complications and diabetes. In     addition, the investigators are wonder whether gut hormones, adipokines and inflammatory     cytokines have some correlation in different severity obese patients,. It is worth to explore     that could intestinal hormones, adipokines and inflammatory factors levels guide us to choice     the different surgical approach to different severity obese patients. The investigators tried     to investigate different surgical methods to alleviate diabetes and other metabolic diseases     mechanisms though hormones and inflammatory factors and adipose tissue inflammation level and     compare the impact of intestinal hormones and inflammatory adipokines of the two surgical     approaches.   "
24585|NCT02963870|"     The recommendation for the treatment of suicidal adolescents, Cognitive Behavioral Therapy     (CBT) targeted new generation offer effective approaches to suicidal crisis and relapse     prevention.      Since 2009, our team is engaged in a partnership between France and Quebec Interuniversity     agreement concluded by a University Picardie Jules Verne-University of Montreal. In this     context, two teams G4 (Amiens and Rouen) have received training in suicidal crisis, including     the security plan by a university instructor and TCC Québec, Dr. Labelle. Furthermore, we     complete a descriptive and prospective study of risk and protective factors for adolescent     suicide in which the Quebec team of Professor Labelle contributes as an expert (sponsor:     Rouen). 200 subjects were recruited on 2 years by 3 (CHU Amiens, CH Compiègne, CHU Rouen)     with an assessment of recurrence at 1 year (lost rates of view = 15%). The first results     highlight the central role of personal coping strategies (coping) in suicidal recurrence. We     want extend this study to validate the implementation of the security plan (safety level)     with suicidal adolescents. The security plan is the initial step of the TCC approach short of     suicidal crisis. It is established after working with adolescents and their families (chain     analysis of the suicidal crisis, coping self-evaluation and identification of support     resources). Developed by Stanley B from Columbia University and adapted for francophone     adolescents R Labelle and JJ Breton wrote this list those resources and coping strategies to     apply in case ideation and suicidal crisis. Signed by the young person and his family, he     then uses to frame the monitoring and management plan of the youth and his family     environment, friendly and professional in case of suicidal crisis.   "
24586|NCT02963857|"     This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF     block) for the anesthesia of the intercostal nerves anterior branches and assesses the     association of the serratus block with a PIF block for the breast surgery.   "
24587|NCT02963844|"     Introduction: Obstructive sleep apnea (OSA) is characterized as a disorder that causes     recurrent episodes of partial or complete obstruction of the upper airways during sleep.     Objectives: In this way, the study will investigate the efficacy of inspiratory muscle     training in improving the severity of obstructive sleep apnea and sleep quality of the     research participants. Methods: The investigators will invite individuals of both sexes     diagnosed with obstructive sleep apnea moderate and / or severe, arising from the Sleep     Laboratory of the Hospital PROCAPE, located in Recife. This is a randomized-controlled trial,     double-blind to be held in two groups: A) Individuals with OSA (moderate or severe) -     Experimental Group: The components of this group hold the IMT with load of 75% of Pimáx. (     assessed weekly) for eight weeks. B) Individuals with OSA (moderate or severe) -Group     control: This group will simulate training, performing no-load training for the same period     the intervention group. All guidance on training and weekly evaluations will be made by the     responsible for the research physiotherapist in Cardiopulmonary Physiotherapy Laboratory     (LACAP - UFPE). Before and after the eight weeks, the groups will be evaluated by     polysomnography, acoustic pharyngometry, tests for respiratory muscle strength     (Manovacuometry) and lung function (spirometry). Expected results: Improvement of severity of     OSA and sleep quality of research subjects after the completion of eight weeks of TMI when     compared to the control group.   "
24588|NCT02963831|"     This is a two-part Phase 1/2 dose escalation and dose expansion study of the GMCSFencoding     adenovirus, ONCOS-102, in combination with anti-programmed death ligand-1 (PDL1) antibody,     durvalumab, in adult subjects with peritoneal disease who have failed prior standard     chemotherapy and have histologically confirmed platinum-resistant or refractory epithelial     ovarian cancer or colorectal cancer.   "
24589|NCT02963818|"     Exploring technology based tools to reduce drinking is important. The purpose of this     research study is to compare different BAC monitoring apps for their effects on alcohol     drinking and ratings of usability among young adults.This study will be conducted in six     phases: a web-based and in-person screening assessment; brief counseling session on the day     before the alcohol drinking session; brief appointment on the day of the alcohol drinking     session; alcohol drinking session; two-week field period; and a follow-up appointment.     Participation in this study will last approximately two months.   "
24590|NCT02963805|"     The purpose of the A-CLASS project was to measure the effect of the 4 hour offer on     children's physical activity, health and physical competence.   "
24591|NCT02963792|"     Due to their difficult and stressful work surgeons are under continuous physical and mental     stress exposing them to increased risk for burnout and lack of professionalism. The present     intervention focuses on providing time and a safe space to debrief and explore personal and     group experiences and dilemmas, as well as acquire coping skills related to burnout,     communication and professionalism.   "
24592|NCT02963779|"     This study is conducted to determine the side effects related to LY2775240 given orally to     healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into     the bloodstream and how long the body takes to get rid of it. Each participant will enroll in     either Part A or Part B of the study, which will last about 14 weeks and 8 weeks     respectively, including screening.   "
24593|NCT02963766|"     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and     pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants     with type 2 diabetes. The study duration is approximately 60 weeks.   "
24594|NCT02963753|"     Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a     clinical syndrome including endocrine and metabolic complications. Recently, some     investigators have been begun performing researches related to the development of gestational     diabetes mellitus (GDM) in pregnant women with HEG because they think about those metabolic     and endocrine complications of HEG.In the literature there are few studies assessing how HEG     has effects on GDM or 75 gram oral glucose tolerance test (OGTT). So the investigators aim to     evaluate the effects of HEG on 75 gram OGTT.   "
24595|NCT02963740|"     The purpose of the study is to demonstrate that breast cancer survivors who need to lose     weight are able to follow a weight loss program which combines modest calorie restriction     with a graduated activity program..   "
24596|NCT02963727|"     Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed     with Knee osteoarthrosis   "
24971|NCT02958826|"     The purpose of this study is to determine the effect surgical lights, surgical smoke, and     surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure.   "
24605|NCT02963610|"     For the phase I component of the trial a classic 3 + 3 dose escalation design will be     utilized, with a fixed dose of pembrolizumab and an escalating dose of the lenalidomide. The     patient population will all have histologically confirmed advanced solid tumor malignancy.     The primary endpoint for the phase I component of this protocol will be determining the     maximum tolerated dose (MTD) of lenalidomide in combination with pembrolizumab.      The phase II component of this trial will utilize a two stage design, initially enrolling 13     patients, followed by 13 more patients if the early stopping criteria are not met. The target     population will include patients with histologically confirmed diagnoses of non-small cell     lung carcinoma, regardless of histologic subtype; who have completed one line of standard     therapy. The primary endpoint for the phase II component of this protocol will be determining     efficacy as measured by progression free survival (PFS)   "
24606|NCT02963597|"     The objective of the study is to evaluate the effect of continuous positive airway pressure     (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF)     patients with obstructive sleep apnea (OSA). The study will also assess changes in functional     parameters, biomarkers, and echocardiographic parameters.   "
24607|NCT02963584|"     The aim of this study is to assess the feasibility and validity of patient-level     randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.   "
24608|NCT02963571|"     To validate the safety and effectiveness of minimally invasive posterior percutaneous pedicle     screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column     injury.   "
24609|NCT02963558|"     This proposal will test the hypothesis that EARLY application of a novel early rehabilitation     therapy in critically ill patients will improve functional outcomes, and change the     functional trajectory of this population. A pilot study of early mobilization with a cycle     ergometer will be performed and translate into humans the pre-clinical mechanisms that may     mediate the effects of early mobility.   "
24610|NCT02963545|"     Single-center, prospective, descriptive and biomedical research with controls, without health     product.      Depression is the second risk factor for stroke as tobacco smoking following hypertension.     Peripheral abnormalities in serotonin parameters were described in depression and tobacco     smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT), which     has notably complex vasomotor effects and of kynurenine which could have cognitive     dysfunction effects.      The aim of this study is to evaluate simultaneously the involvement of serotonin and     kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after     the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2) and 3     months after the cerebral infarction.   "
24620|NCT02963415|"     The study will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined     with concurrent cycling on a recumbent stationary cycle, also known as exergame that     seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized     with cycling to promote cognition.   "
24621|NCT02963402|"     We can speculate that the best responders to tocilizumab should have multiple related     elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play     its beneficial role. The study of these elements and its pathways could help identify the     best responders to tocilizumab treatment.   "
24622|NCT02963389|"     This is an open-label, single ascending dose study to evaluate safety, tolerability, and     pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma     patients   "
24665|NCT02962830|"     The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology     (e.g., malformation) or a diagnostic or therapeutic procedure.      To date, there is very little data and no consensus on fetal analgesia. The aim of the     investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic     injection.   "
24611|NCT02963532|"     The timing of extubation following surgery and anesthesia in young children is a complex     decision frequently guided by the experience of the clinician. The clinician frequently must     make a decision based on assimilating multiple cues that may or may not demonstrate that the     patient is ready for extubation such as eye opening, conjugate gaze, spontaneous ventilation,     and end tidal agent concentration. At this time there is no published data on the predictive     ability of individual extubation criteria for young patients undergoing anesthesia for     surgery so most practice is based solely on experience and anecdotal teaching. In some cases     if the timing is misjudged and the patient is extubated too early negative airway reflexes     such as breath holding and laryngospasm may take over creating a critical situation in which     the patient forgoes gas exchange and rapidly desaturates with the potential for bradycardia     and further cardiovascular collapse.      Routine criteria used to determine fitness for extubation have been primarily described in     the intensive care unit literature and may be less relevant in the operating room in the     setting of routine general anesthetics. Most predictors including adequate tidal volume,     presence of conjugate gaze, eye opening, patient movement purposeful or otherwise, low end     tidal anesthetic agent concentration, response to physical or verbal stimulation and the     laryngeal stimulation test have not previously been evaluated to determine their individual     predictive value in deciding if the presently anesthetized patient now emerging is ready to     be extubated.      In order to perform a laryngeal stimulation test the patient must be breathing spontaneously     and practitioner will gently move the endotracheal tube up and down stimulating the larynx.     In patients in stage 2 of anesthesia, the clinician will typically observe a cough or series     of coughs followed by a respiratory pause of greater than 5 seconds. In this situation the     patient has not adequately passed through stage 2 and remains at increased risk for apnea,     breath holding, or laryngospasm. If the patient is in stage 1 of anesthesia the clinician     will observe a cough followed by a brief pause (less than 5 seconds) or almost immediate     return to spontaneous ventilation.      In conclusion, their exist no quantitative data on the predictive value of these various     criteria for extubation and the goal of our study is determine the indivdual predictive value     of different criteria in determing fitness for extubaion in young pediatric patients by     recording the presence or absence of various criteria in pediatric patients at the time of     extubation during routine anesthetic care.   "
24612|NCT02963519|"     Primary objective:      Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates     the formation of a quality granulation tissue and reduces preparation time to a cover     gesture.      Secondary objectives:        -  Evaluate the success of hedging gesture        -  Assess the quality of the bud by colorimetry        -  Assess tolerance        -  Collect medical and economic data on the care of patients included        -  Evaluate the quality of life of patients        -  Assess patient comfort        -  Evaluate the ease of use for the caregiver   "
24614|NCT02963493|"     This study will evaluate melflufen in combination with dexamethasone in the treatment of     relapsed refractory multiple myeloma in adult patients with disease refractory to     pomalidomide and/or daratumumab. All patients in the study will be treated with melflufen on     Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.   "
24627|NCT02963324|"     The present study assesses the pharmacokinetic profile of Ivermectin (IVM) in healthy human     volunteers and aims to create a physiologically-based pharmacokinetic model. Planned     indication is the prevention of malaria transmission.   "
24615|NCT02963480|"     Similar to poly-trauma, acute myocardial infarction, or stroke, the speed and appropriateness     of therapy administered in the initial hours after severe sepsis develops are likely to     influence outcome. However, the crux of matter is the early diagnosis lacking of high     sensitive and specific test, in contrary to, for instance, the acute coronary syndrome, where     the highly sensitive Troponin T is measured and increased values are fix component of the     diagnosis and definition of acute myocardial infarction. Cardiac surgery can initiate a     systemic inflammatory response syndrome (SIRS) induced by extrinsic and intrinsic factors,     which are associated in the pathogenesis of postoperative complications. SIRS is closely     related to sepsis, but in contrast sepsis is induced by infection. This strong inflammatory     response induces malfunction of the peripheral circulation with increased lactate levels,     pronounced fluid accumulation and increased need of vasopressors.      The investigators want to assess the timing dynamic of release of IL-6 apart from established     markers like CRP, leukocytes, PCT. Target of this is to estimate the time-scope and -advance     of an IL-6 axis panel toward the measurement of standard inflammation parameters in     inflammatory response to surgical trauma as a pre-figuration of non-infectious SIRS and to     search for a eligible cut-off of IL-6.   "
24616|NCT02963467|"     Smoking is one of the world's leading health hazards. Besides being a major risk factor in     the etiology of COPD and lung cancer, cigarette smoke is also a causative agent lung diseases     characterized by bronchiolar and interstitial inflammation. However, the associated lung     pathology of smoking is not only a risk in the development of lung diseases, but also widely     recognized as a major risk factor associated with perioperative respiratory and     cardiovascular complications. Apart from the long term effects of cigarette smoke, acute     effects of the inhalation of cigarettes smoke may influence the course of lung pathology. The     inhalation of smoke causes inflammation in the lung by inducing chemotaxis and activation of     neutrophils and macrophages and induces oxidative stress. As the acute inflammatory response     to smoke inhalation seems to be the underlying mechanism for chronic diseases of smokers,     exploring the field of the acute pulmonary changes after exposure to cigarette smoke is     highly relevant. One reason for acute hypoxia and injury during smoking might be a severe     mismatch of ventilation and perfusion of the lung. Using the multiple inert gas elimination     technique (MIGET), a distribution of ventilation-perfusion ratios in the lung can be     calculated by analyzing data on the retention and excretion of six infused inert gases. A     saline solution containing the gases is infused intravenously. When passing through the lung     the gases are either eliminated from the blood or retained depending on their partition     coefficient and local V/Q ratio. The concentrations of the gases are measured in the mixed     venous blood or the mixed expired gas and the arterial blood allowing for the calculation of     retention and excretion and the derivation of V/Q distribution. MIGET is the experimental     gold standard to determine the Ventilation-Perfusion ratio of the lung. The aim of this study     is to show the acute effect of smoking on ventilation/perfusion ratio distribution in the     lung in otherwise healthy smokers.   "
24617|NCT02963454|"     To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the     extracellular fluid of the skeletal muscle following levosimendan administration in patients     with septic shock.   "
24618|NCT02963441|"     Diabetes affects 29.1 million people or 9.3% of the population of the United States. Results     of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients     have some degree of diabetic retinopathy (DR) and that as many as 8% have severe,     vision-threatening forms of DR. Early laser photocoagulation in high-risk proliferative     diabetic retinopathy (PDR) has been shown to decrease the relative risk of vision loss by as     much as 52%. Injections of anti-VEGF agents preserve and improve vision in people with PDR     and/or diabetic macular edema. Despite effective treatment however, tens of thousands of     people with diabetes are going blind each year largely because they don't undergo annual     screening for retinopathy. Currently, only some 50%-60% of people with diabetes have a yearly     eye exam and there may not be enough eye specialists to see the balance.      To address the issue of patient compliance with diabetic retinopathy screening, IDx-DR was     developed as an automated screening device designed to analyze fundus images for the presence     of lesions and other disease features associated with diabetic retinopathy. This study has     been designed to validate the safety and efficacy of the device at the frontlines of     healthcare.   "
24619|NCT02963428|"     The study aims to improve obstetrical care by managing gestational weight gain (GWG) among     high risk women in an effort to reduce maternal and fetal complications.   "
25000|NCT02958449|"     Comparing standard wound closure technique with drains (control) to standard wound closure     techniques with TissuGlu® and no drains (test) in mastectomy   "
24623|NCT02963376|"     Stroke is the fifth leading cause of death in the United States and is the leading cause of     long term disability. Distinct geographic disparities in stroke mortality, with highest rates     in the southeast United States including Arkansas, are known as the stroke belt. There the     average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the     leading cause of serious long-term disability. Between 2012 and 2030, disability and medical     costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with     the majority of the projected increase in costs arising from those 65 to 79 years of age.      There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in     85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion     of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue     plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood     vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it     reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond     the effective time window for therapy is a common reason for failure.      To reduce the devastating impact of stroke on individuals and society, the investigators     continue to seek ways to improve functional recovery and limit ischemic damage in stroke     patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has     recently shown strong positive effects in pre-clinical animal models of acute ischemic     stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants     and blood substitutes yet none have been successful.   "
24624|NCT02963363|"     The purpose of this study is to assess the feasibility of a home-based adapted physical     activity during neoadjuvant chemotherapy for HER2+ breast cancer.   "
24625|NCT02963350|"     -  To provide access to BMN 190 to patients with CLN2 disease who cannot participate in a          clinical trial.        -  To collect additional information on the safety and tolerability of BMN 190          administration in patients with CLN2 disease.   "
24626|NCT02963337|"     Remifentanil may be an ideal drug for labor analgesia due to its pharmacodynamic and     pharmacokinetic profile. As compared to epidural analgesia, it demonstrated satisfactory for     pain relief at the beginning of labour with a gradual elevation of pain scores as labour     progresses. However, fast onset and limited time efficacy may render it useful in multiparous     with a faster labor progression, thus even making it an alternative to single-shot spinal     analgesia.   "
24631|NCT02963272|"     Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2     years, 30% of rehospitalization within 1 month). It is also a major cause of health burden     representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these     costs are due to hospitalization.      Besides physical examination and echocardiography, biology may help refine the diagnosis, but     also could provide powerful prognostic parameters.      This study aims to assess the value of ST2 in the management of patients admitted for HF to     reduce readmission at one month.   "
24632|NCT02963259|"     This post-marketing evaluation has been designed to consistently investigate the subject's     preference when switching from a Medtronic® constant voltage or constant current device to a     St Jude Medical Infinity™ or St Jude Medical BrioTM constant current system. As electrodes     will not be re-positioned, differences in subject's preference are to be explained by the     difference in shape of the delivered pulse or waveform between the two systems.   "
24633|NCT02963246|"     Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual     control group in patients with bowel disease. Design: randomized controlled trial. Setting:     Outpatient setting. Population: patients who attended bimonthly check up.   "
24634|NCT02963233|"     The treatment of pediatric supracondylar humerus fractures is controversial, but despite the     injury's high incidence there is a lack of high level evidence to guide operative versus     non-operative decision making for displaced fractures with an intact posterior cortex     (Gartland Type II). This study aims to prospectively compare clinical, functional, and     radiographic outcomes between operatively and non-operatively treated patients using a     prospective multi-centre cohort design.   "
24635|NCT02963220|"     The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for     avoidant/restrictive food intake disorder (ARFID) in 10 youth with ARFID (ages 10-21y).   "
24636|NCT02963207|"     OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an     established one for colorectal lesions in a randomised trial between 2013 and 2015.   "
24637|NCT02963194|"     To determine whether the neuropeptide oxytocin (OXT) influences self-processing by     investigating whether it increases the endowment effect in relation to both self and others.   "
24638|NCT02963181|"     Neurogenic Orthostatic Hypotension (NOH) is clinically defined as a consistent drop in     systolic blood pressure (SBP) ≥30mmHg upon standing from a seated or lying position. However,     50% of NOH patients also have associated supine hypertension. It has been proposed that     supine hypertension is the result of intact post-ganglionic sympathetic nerves and therefore     due to residual sympathetic tone. Furthermore, research investigating the effects of     melatonin shows blood pressure implication of this naturally secreted hormone. Specifically,     melatonin has been investigated as a non-traditional anti-hypertensive agent for patients     with essential and nocturnal hypertension. Central and peripheral mechanisms have been     proposed to help explain how melatonin reduces blood pressures. Therefore, we aim to identify     NOH patients as having either intact or denervated post-ganglionic sympathetic nerves,     monitor the correlation to supine hypertension and subsequently investigate the effects of     melatonin on blood pressure in these patients.   "
24641|NCT02963142|"     Severe community acquired pneumonia is common and associated with high mortality.     Conventional microbiological diagnostics identify pathogens in approximately half of cases,     which is inadequate for both clinical and epidemiological purposes. This study applies     next-generation sequencing based metagenomic techniques to patients with extremely severe     community acquired pneumonia, to investigate the microbiome of severe community acquired     pneumonia and evaluate metagenomic approaches as diagnostic tools.   "
24642|NCT02963129|"     Compare the frequency of epistaxis and quality of life related to nasal bleeding in patients     with HHT colonized with sataphylococo before and after being treated with mupirocin ointment.   "
24643|NCT02963116|"     This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center,     crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of     rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs     AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy     Volunteers. The study will be performed at a single study center.   "
24644|NCT02963103|"     The objective of this study is to observe and evaluate the change in renal function following     conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.   "
24645|NCT02963090|"     This is a multi-institutional, randomized, open-label phase II study of pembrolizumab     compared to topotecan, administered to patients with SCLC who have progressed or relapsed     after first-line treatment with etoposide and platinum. Patients will be randomized in a 2:1     fashion to receive pembrolizumab or topotecan. Participants in the topotecan arm that     progress will be allowed to cross-over to the pembrolizumab arm.   "
24646|NCT02963077|"     The primary objectives of the study are to evaluate the safety, tolerability and     pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In     addition, will evaluate A4250 in combination with cholestyramine.   "
24647|NCT02963064|"     This is a single-arm, open label, Phase 1 study to assess the safety and tolerability of     CD34+CD90+ hematopoietic stem cell (HSC) allografts infused into patients with SCID who are     conditioned for transplantation with AMG 191, an antibody that targets CD117 present on     endogenous HSC. The target dose of CD34+CD90+ HSC will be >1 x 10^6 cells/kg and the optimal     conditioning dose of AMG 191 will be determined during dose escalation.   "
24648|NCT02963051|"     The purpose of this study is to determine the safety and optimal dosing of intravenous copper     chloride and disulfiram in men with metastatic castrate-resistant prostate cancer (CRPC).     Eligible men will have neuroendocrine prostate cancer (NEPC), adenocarcinoma CRPC with     non-liver/peritoneal metastases (lymph nodes, bone, or lung) or adenocarcinoma CRPC with     liver and/or peritoneal metastases. Subjects will receive three doses of intravenous copper     chloride and take disulfiram and oral copper gluconate until disease progression (up to two     years). Subjects will also undergo a PET scan with radioactive copper 64 to measure the     levels of copper in their tumor. The central hypotheses of this project are that (a) copper     chloride and disulfiram are safe to give together and that (b) the combination of disulfiram     with copper will have efficacy for both mCRPC and NEPC.   "
24650|NCT02963025|"     One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or     facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a     mechanical ventilation approach that is able to maintain adequate gas exchange, while     protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the     use of lower tidal volumes is helpful to avoid over-distension, but can result in increased     atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels     of positive end-expiratory pressure (PEEP).      Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that     this may improve oxygenation and protect against PPC. Up to now, it is not known whether high     levels of PEEP combined with RM are superior to lower PEEP without RM for protection against     PPCs during OLV.      Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and     recruitment maneuvers, as compared to ventilation with lower levels of PEEP without     recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing     thoracic surgery under standardized one-lung ventilation.   "
24651|NCT02963012|"     A prospective trail. Pregnant women in the first trimester with positive BHCG and no     visualization of gestational sac will be recruited.      The correlation between endometrial pattern and ectopic pregnancy will be assessed.   "
24652|NCT02962999|"     Chronic obstructive pulmonary disease (COPD) patients often undergo thoracic surgery due to     lung cancer and emphysematous changes. One lung ventilation (OLV) used in thoracic surgery     aggravates hypoxia and hypercapnia increasing intrapulmonary shunt and dead space.Ketamine     provide bronchodilation by inhibiting the reuptake of catecholamines in the circulation. It     also serves relaxation of bronchial smooth muscle. Our aim in this study, effects of ketamine     on arterial oxygenation, the shunt fraction and the lung mechanics in patients with COPD who     administered OLV because of thoracic surgery. Thirty patients with COPD who undergo     thoracotomy for lung lobectomy will be included in this study. Patients will be randomly     divided to a control group (%0,9 saline- CG) or a keta (ketamine- KG) group. KG will be     administered 0,5 mg/kg/hour ketamine infusion after the induction, CG will be administered     saline infusion. Peak airway pressure (Ppeak), plato airway pressure (Pplato), static     compliance, shunt fraction and arteriel blood gas values (Pa02, PaC02) will be recorded     before initiation of OLV and 30 minutes intervals after initiation of OLV.To evaluate the     postoperative pulmonary complications, Pa02, PaC02 in blood gas and Pa02/Fi02 values will be     recorded 20 minute after arrival at postoperative care unit. Patients will be evaluated for     pneumonia, atelectasis and acute lung injury at postoperative 72 h and findings will be     recorded. 30 day mortality will be recorded.   "
24664|NCT02962843|"     The purpose of this study is to evaluate whether training teacher and staff in the Incredible     Years (IY) Teacher Classroom Management (TCM) program reduce behavior problems and promote     social competence in student aged 6-8 years (school) and in children aged 3-6 year     (day-care). To examine group differences from baseline to 8-9 months after, a     quasi-experimental control group design with pre- and post-measurements was used.   "
24653|NCT02962986|"     Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and can     have unwanted side effects on both mother and fetus if not treated promptly. Phenylephrine     has been the drug of choice to treat this spinal-induced hypotension. Although phenylephrine     is safe to use for this indication, it has been associated with reflex bradycardia and a     reduction in cardiac output.      Norepinephrine is a potent vasopressor used to treat hypotension in the critical care     setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and     have shown that it can be used safely and also has favourable hemodynamic properties when     compared to phenylephrine, with less bradycardia and less depression of cardiac output.      The investigators recently conducted a study to determine the ED90 of norepinephrine, and now     plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension     following spinal anesthesia for cesarean section.      The investigators hypothesize that norepinephrine, when given as a bolus to prevent post     spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia     when compared to phenylephrine in patients undergoing elective cesarean delivery under spinal     anesthesia.   "
24654|NCT02962973|"     The purpose of this clinical investigation is to evaluate the safety and performance of the     Carmat Total Artificial Heart (TAH) in patients suffering from advanced heart failure and     requiring biventricular support.      Each subject receiving the Carmat TAH is followed to the primary and secondary endpoints at 6     months, with a subsequent follow-up period extending to 2 years post implant.      The results of the study will be used to support a CE mark application.   "
24655|NCT02962960|"     This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and     tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult     Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result     and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition,     the efficacy of anifrolumab on SLE skin manifestations will be characterized.   "
24656|NCT02962947|"     The effectiveness of propranolol in infantile hemangiomas, the apparent better response to     propranolol in breast cancer and the use of propranolol in a proportion of patients who did     not develop melanoma recurrence suggested to use this unselective β---blocker to test the     study hypothesis. The investigators propose a randomized double---blind placebo---controlled     clinical trial (RTC) to evaluate whether the treatment with propranolol 80 mgR/die reduce the     risk of CMM recurrence and mortality. Patients with resected stage II/IIIA CMM will be     recruited in various Centers in Italy. Participants will be randomly assigned to propranolol     treatment or placebo (1:1 ratio), treated for at least 1 year and followed for 2 years.     Recruitment will proceed simultaneously at the different Centers, and will be completed in 2     years. The primary outcome of the entire trial will be, however, estimated by assessing a     reduction in overall mortality at five years. The investigators will also evaluate general     CMM recurrence and CMM specific mortality.   "
24684|NCT02962583|"     Limited interventional human studies suggest that probiotic supplementation may be a     beneficial strategy for promoting weight loss when added to a nutritional intervention via     their effects on lipid absorption and metabolic signaling molecules. The purpose of this     study is to evaluate the effects of addition of a probiotic supplementation to a weight loss     intervention on body weight, body composition and overall health in overweight adults.   "
24657|NCT02962934|"     The purpose of this study is to try to find out how critically ill patients receiving the     antibiotic, ceftolozane-tazobactam, process it in their body. Investigators would like to     study if the antibiotic concentrations during a dose of this antibiotic reaches the right     concentrations necessary to kill the bacteria that is causing the infection. The process by     which a drug travels through the body in blood, how it is broken down and removed by the body     is called pharmacokinetics (PK). We can measure the PK by taking blood samples at specific     times after the antibiotic is given.      Investigators would like to do the study in patients receiving dialysis and patients who are     not receiving dialysis. This information about how the antibiotic is processed in the     critically ill patient is unknown and it is important to know whether the doses doctors give     patients to fight infection are adequate. If antibiotic concentrations are low in the blood,     it gives the bacteria an opportunity to become resistant to the antibiotic which can lead to     the antibiotic being less effective against bacteria potentially exposing future patients     with infections to a limited range of effective antibiotics.      Patients will be consented, and given the antibiotic as prescribed. Blood samples will be     taken from the drip that is already in the patients arm just as the antibiotic starts, at 15     and 45 minutes, at 1,2,3,4,5,6,7 and 8 hours. Patients who are on dialysis will have the     blood samples taken from the dialysis machine before the blood reaches the dialysis filter     (same blood samples as the non dialysis patients) and also bloods samples taken after the     filter at 45 minutes, 2 and 6 hours. Dialysis patients will also have 5 separate samples of     ultrafiltrate taken (approximately 10mls) - ultrafiltrate is the waste product of the     dialysis process. The total amount of blood will be 40mls which is equal to about 2     tablespoons. The dialysis patient will have 50mls of blood taken.Information about the     patients ICU stay will also be recorded.   "
24658|NCT02962921|"     Our investigation studies the role of acute insulin administration on the diabetic heart, its     corresponding effective blood-insulin level and the time-course applicability of insulin in a     routine clinical setting.      A case series of six male (48.1 ± 4.9 y/o) patients with controlled diabetes (HbA1c of 6.6 ±     0.3%, disease duration of 14.4 ± 6.7 yr). Each subject was evaluated for glucose homeostatic,     hemodynamic and echocardiographic systolic and diastolic parameters at baseline and following     two successive insulin-load steps of a euglycemic hyperinsulinemic clamp study, each 2 h in     duration. Results are presented as a mean ± SEM and analysed using the student's t-test.   "
24659|NCT02962908|"     FLU-v is a vaccine that aims to protect against a wide range of flu viruses. The purpose of     this study is to measure the immune responses induced by FLU-v vaccine. This study will look     at how safe FLU-v is when administered and how successful it is in preventing flu or reducing     the severity of the flu symptoms.      The study requires 222 healthy volunteers 18-60 years old. Participation in the study will     take a maximum of 7 months and consists of 5 visits. During visit 1, subjects will be     examined by a doctor to make sure they are eligible to enter the study. A 15ml blood sample     (a tablespoon) will be taken to check general health followed by a general physical exam.     Medical history and some personal information will be collected. Subjects that have received     the traditional flu vaccine in the past 6 months, and those females who are pregnant or     breastfeeding will not be allowed in the study. Subjects of childbearing age must agree to     use effective contraceptive methods.      At visit 2, subjects will be randomly allocated to one of the four treatment groups     summarised below:        -  Treatment 1: FLU-v (test vaccine) at the start of the study (Day 0) and then again 21          days later        -  Treatment 2: FLU-v (test vaccine) with an additional substance added [known as Montanide          ISA 51] which improves the effect of the test vaccine. Injection will be given on Day 0          and then Placebo (no test vaccine) alone 21 days later        -  Treatment 3: Placebo (no test vaccine) injection on Day 0 and then 21 days later        -  Treatment 4: Placebo (no test vaccine) with an additional substance added [known as          Montanide ISA 51] on Day 0 and then Placebo (no test vaccine) alone 21 days later          Treatment will be injected under the skin in the upper arm on day 0 (visit 2) and 21          days later (visit 3). Blood samples will be taken before treatment (day 0), and on days          42 (visit 4) and 180 (visit 5) to the immune responses induced by the vaccine.      Subjects will be asked to complete a diary card to write down any side effects that they may     experience after vaccination. Subjects will also be asked to complete another diary card to     document any flu-like symptoms experienced between December 2016 and March 2017, this time is     officially considered as the flu season. During this period, if the subject experiences     flu-like symptoms, a collection of a nose and tonsil swab will be arranged by the study site     to confirm whether they have the flu or not.   "
24660|NCT02962895|"     This study will determine the dose-response relationship of VAY736 for key efficacy and     safety parameters   "
24661|NCT02962882|"     A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User     Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury     Prevention in the Intensive Care Unit   "
24662|NCT02962869|"     To evaluate the potential of a test material to produce a photoallergic response   "
24663|NCT02962856|"     To determine the phototoxic potential of a topically applied article in human subjects   "
24666|NCT02962817|"     Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes     of primary care physicians and nurses towards the treatment of chronic nonspecific low back     pain to subsequently develop a biopsychosocial educational tool using a web platform. The     secondary aim of this project is to evaluate the effectiveness of this educational     intervention about pain neurophysiology and fear-avoidance beliefs, using a web platform for     primary care physicians and nurses.      Methods: Exploratory sequential mixed method design. For the qualitative phase of this study,     researchers will use personal semistructured interviews. For the quantitative phase the     authors will use an experimental study design.      Subjects: medical and nursing staff working in primary care centers in the city of Lleida,     Spain.      Expected outcomes: the authors expect to change and modify wrong beliefs and attitudes about     chronic low back pain of physicians and nurses working in primary care settings, using a     web-based educational tool with the additional result of increasing knowledge on pain     neurophysiology and reducing fear-avoidance beliefs.   "
24667|NCT02962804|"     There are two primary aims in the study: 1) to determine the tolerability and feasibility of     combination hypofractionated radiation therapy and PD-1 inhibition with nivolumab, and 2) to     determine the ability of hypofractionated radiation therapy to enhance response rate from     PD-1 inhibition versus PD-1 inhibition alone by comparing the observed response rate under     the combination therapy with a previously reported response rate under inhibition alone.   "
24668|NCT02962791|"     Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with     symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a     lack of response is observed for about 25-30% of them whatever the response criteria used     either based on the clinical status (NYHA class, Packer clinical composite score) or on     ventricular remodeling parameters assessed by echography (Left ventricle end of systole     volume). This rate has remained remarkably stable since the therapy started and has motivated     many studies to better understand the underlying physiopathology and the CRT action     mechanisms.      Among the various research axes to improve CRT response and responders rate, increasing the     number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has     been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three     studies. In all cases, it demonstrated a significant improvement of cardiac performance     whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility     of this approach for long term CRT delivery was demonstrated during a previous study. First     results with triple-site ventricular stimulation are encouraging and its clinical efficacy     should now be tested on a larger population in order to conclude on its interest for CRT     candidates.   "
24669|NCT02962778|"     This study evaluates RAS peptides profiles in patients with treatment resistant arterial     hypertension.   "
24699|NCT02962388|"     Prospective national multicenter randomized open label phase IIb RUXBETA trial.   "
24670|NCT02962765|"     Prospective, multinational, non-interventional post-authorisation study to collect additional     clinical data and to ensure consistency in the long-term between the outcome from     pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients)     and routine clinical practice. Besides aspects such as general product safety and efficacy,     there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis     of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor     testing in the laboratory.   "
24671|NCT02962752|"     The current study uses a double-blind, placebo-controlled, randomised cross- over design to     assess the pharmacodynamics of the platelet MAO-B inhibition, plasma prolactin levels and     blood glucose levels after consumption of a single serve of 'Blackadder' blackcurrant juice.   "
24672|NCT02962739|"     Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide     (F/TAF) works for treatment of chronic HIV, or prevention of HIV acquisition. Methods to     measure medication adherence to Tenofovir disoproxil fumarate (tenofovir DF, TDF), a similar     but different prodrug of tenofovir, have been developed but cannot be extrapolated to F-TAF.     By measuring F-TAF (the drug) and metabolites in the blood cells and dried blood spots, the     study plans to see if these results predict adherence to taking the drug. The goal of this     study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots     (DBS) change in a predictable way. This study will mimic different levels of adherence (33%,     67%, and 100% of daily dosing) using directly observed therapy (DOT) to establish the     relationship between F-TAF in dried blood spots and adherence. Investigators will also     measure drug in hair clippings to see if hair or DBS are a better predictor of adherence.   "
24673|NCT02962726|"     The aim of this study is to evaluate the effect of starvation and recovery in adolescent     anorexia nervosa patients in regard to microbiome activity and composition and to elucidate     potential connections between weight gain, depression and other comorbidities, further to     capture hormone levels and inflammation parameters in a longitudinal design.   "
24674|NCT02962713|"     Although the Atraumatic Restorative Treatment (ART) is well settled in the literature     regarding occlusal-proximal cavities, the longevity of these restorations is still lower when     compared to occlusal ones. This factor is often associated with low mechanical properties of     glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate     the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC     Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives     materials in occlusal-proximal ART restorations of primary molars. Children aged between 4     and 6 years, will be selected in schools in the city of Barueri, São Paulo. All restorations     will be held following the precepts of the ART and the manufacturer's instructions. The     restorations will be evaluated after 1, 6, 12 and 24 months according to Roeleveld et al.     (2006) criteria. To verify the survival of the restorations will be used Kaplan-Meier     survival analysis and log rank test. To evaluate the association between the clinical     variables, Cox regression test will be applied. For the cost analysis will be used analysis     of variance. The level of significance for all tests will be considered to 5%.   "
24675|NCT02962700|"     The aim of the study was to investigate whether CVVH, in comparison to intermittent     haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied     by muscle microdialysis   "
24676|NCT02962687|"     The purpose of this study is to examine the feasibility and acceptability of a 12-week care     management program for medically complex Veterans with cognitive impairment, delivered via     telephone or videoconferencing.   "
24678|NCT02962661|"     The goal of this clinical research study is to learn if adding mesenchymal stem cells (MSCs)     to standard of care drugs can help control heart failure that may have been caused by     anthracyclines. The safety of the MSCs will also be studied.      MSCs are a type of stem cell that can be removed from bone marrow and grown into many     different cell types that can be used to treat cancer and other diseases, such as heart     failure. The MSCs used in this study were collected from healthy donors and are stored and     grown in a lab at MD Anderson.   "
24679|NCT02962648|"     Evaluation of safety and efficacy of IV iron isomaltoside re-dosing.   "
24680|NCT02962635|"     A precise volume status assessment is critical to improve outcome of patients on dialysis.     Yet, accurate assessment of fluid status remains a challenge. Currently, this is performed by     clinical evaluation and regular weight measurements before and after dialysis, which is not     always accurate. Moreover, bioimpedance technology is used in some centers for quantitative     assessment of total body water. This approach has been validated for the assessment of volume     status in dialysis patients, but requires the acquisition of specific tools and is time     consuming. So far, no biomarker has been validated to quantify volume status in dialysis     patients. Application of biomarkers might contribute to a better dialysis prescription and     therefore to outcome improvement in dialysis. The investigators aim to investigate the role     of a novel biomarkers (sCD146) to assess volume status in dialysis patients   "
24681|NCT02962622|"     The study evaluates the association between soluble insulin receptor dysfunction,     cardiorespiratory fitness, and HIV associated neurocognitive disorder (HAND). Those who     volunteer to participate in the study will have two evaluations at study entry that include a     dual x-ray absorptiometry (DEXA) densitometry, anthropometry, neurocognitive testing, blood     and urine samples for metabolic testing, and a cardiorespiratory fitness testing. DEXA will     be conducted in the Endocrinology Unit at the University Hospital, Medical Center (letter of     support included). The cardiorespiratory fitness testing will be conducted in the AIDS     Clinical Trials Unit (ACTU) project, University of Puerto Rico, Medical Sciences Campus, and     the Puerto Rico Clinical and Translational Research Consortium. Then, participants will be     invited to participate in a 6-week, 3 days/week individualized exercise program. The exercise     program will be conducted at the University of Puerto Rico Medical Sciences Campus. After     completion of the exercise program, study entry evaluations will be repeated. The duration of     the study will take approximately 10 weeks.   "
24682|NCT02962609|"     The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and     Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants     upon their physiological characteristics and feeding performances.   "
24753|NCT02961673|"     A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in     Subject with Moderate to Severe Glabellar Lines   "
24685|NCT02962570|"     The main goal of this study is to determine if supplemental oxygen given only when the     patient is inspiring (demand delivery) is more effective than constant-flow oxygen given     during all phases of the breath regardless if the patient is breathing it in. A previous     study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the     concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given     in demand (inhalation only) mode. A secondary goal is to determine in patients, whether     turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon     Dioxide) monitoring. This was found to be the case in the previous volunteer study.      The investigators want to determine if these improvements are also observable in relatively     healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand     mode will be determined by measuring the resulting difference in oxygen saturation and     end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery     (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each     mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2     measurement will be compared with those during the brief time when O2 flow is stopped.   "
24686|NCT02962557|"     This study will explore the feasibility of an idea to use standard, FDA-approved patient     monitors to detect ventilatory depression and then play a recorded nurse's voice to prompt     patients by name to breathe. The voice prompt will occur in addition to when the traditional     alarms are sounded by the monitors. The study device consists of commercially available     physiologic monitors, a speaker, and a laptop computer. The physiologic monitors include a     pulse oximeter with a motion sensor, capnometer, and nasal airway pressure sensor (built into     a nasal cannula). Nasal pressure is a commonly used clinical monitor for sleep apnea     detection during polysomnography testing in sleep labs.   "
24687|NCT02962544|"     Aim of the work is to compare the results of femtosecond assisted LASIK and small incision     lenticule extraction (SMILE) as regards safety, efficacy and predictability. As a secondary     outcomes , the investigators will compare the results of both techniques on corneal     biomechanics, dry eye measures, corneal asphericity and higher order aberration.   "
24688|NCT02962531|"     An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01     in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600     mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or     fasted state   "
24707|NCT02962271|"     Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked with     rash of psoriasis, but there's still great controversy regarding the exact relationship     between them. Our study is to investigate the characteristics and differences of the     ultrasonic imaging of enthesopathy in the lower extremity in patients with PsA and Ps, to     explore the risk factors of Ps developing into PsA in the long term course.   "
24689|NCT02962518|"     Keloids are benign cutaneous lesions, arising from proliferating fibroblasts. Keloids of the     ear may occur after helix piercings and are difficult to treat, since they tend to form     recurrences. Guidelines suggest multimodal therapy, however, recurrence rates remain high and     prospective randomized trials are still missing.      To unravel the most effective combination of therapeutic options for keloids of the ear, 20     patients will be enrolled in a prospective, randomized trial. Patients either undergo surgery     using the fillet technique and intra-lesional injections of triamcinolone 10mg /ml every 4     to 6 weeks for 6 months, or they are additionally treated with a non-customized pressure     device.   "
24690|NCT02962505|"     The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the     potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety     of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant     therapy, recruitment manoeuvres, etc.) and for early recognition of complications like     pneumothorax and endotracheal tube misplacement. The study design is purely observational.   "
24691|NCT02962492|"     The study investigations include evaluation of the acute effects of a single dose of     dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or     placebo under insulinopenic condition and the long term effect under basal conditions before     and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of     Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and     lipolysis.   "
24692|NCT02962479|"     This study aims to compare biological communities in stool samples obtained from age, diet     and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS)     never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing     spondylitis previously or currently treated with TNF inhibitors, subjects with     non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor     (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or     currently treated with TNF inhibitors and healthy participants.      The differences in fecal microbiota composition will be explored using shotgun metagenomic     sequencing through the University of Washington. The investigators predict that this study     will confirm a significant difference between the fecal microbiota composition (FMC) of both     AS and nrSpA patients and controls.   "
24693|NCT02962466|"     Performing an additional non invasive oocyte diagnostic test based on cumulus gene expression     could improve the outcome of the ART cycle.   "
24694|NCT02962453|"     The aim of this study is to determine the clinical efficacy of gait rehabilitation robot     through cortico-spinal-muscular pathway activation of the muscles remotely located from the     end-effecter in patients after total knee arthroplasty.   "
24695|NCT02962440|"     This trial is conducted in Europe. The aim of the trial is to investigate the absorption,     metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male     subjects.   "
24696|NCT02962427|"     The purpose of this research study is to compare the effectiveness of a sphenopalatine     ganglion block to an epidural blood patch for post-dural puncture headache relief in     randomized postpartum parturients over a 48 hour period.   "
24697|NCT02962414|"     The purpose of this study is to evaluate the long-term safety in patients with TSC and     refractory seizures who are currently receiving everolimus treatment in the     Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued     treatment as judged by the investigator at the completion of EXIST-3   "
24698|NCT02962401|"     Prospective national multicenter open label phase II Remodel WM3 trial   "
24700|NCT02962375|"     Primary object is to determine if 100% orange juice with enzyme-treated orange pomace fiber     compared to a 100% orange juice will reduce 2 hr glycemic response as measured by glucose     area under the curve.      Secondary object is to assess if 100% orange juice with enzyme-treated orange pomace fiber     compared to a 100% orange juice will reduce 2 hr insulin iAUC response.   "
24701|NCT02962362|"     The purpose of this study is to collect patient outcomes data for patients who are undergoing     an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized     Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient     outcomes data are important for assessing the post-market safety and effectiveness of     orthopedic medical devices.   "
24702|NCT02962336|"     Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,     Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of     Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22     days.   "
24703|NCT02962323|"     Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets     40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of     studies were separated by a washout period of 7 days.   "
24704|NCT02962310|"     Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets     40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of     studies were separated by a washout period of 7 days.   "
24705|NCT02962297|"     VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to     evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults     with NASH compared to treatment with placebo in China.   "
24706|NCT02962284|"     This is an open-label, single-arm, multi-center extension study to evaluate safety in     patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).     Patients will have successfully completed an 84-day treatment with abiraterone acetate in a     previous trial. Results from the final visit of the previous study will be used to determine     patient's eligibility for this study. Patients in this study will be eligible to receive     open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of     serum testosterone and PSA levels will be monitored. Disease progression will be assessed by     PCWG2 criteria.   "
24708|NCT02962258|"     Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,     Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of     Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22     days.   "
24709|NCT02962245|"     The research aim to find out whether berberine can reduce the annual recurrence rate of     ulcerative colitis in remission.      A total of 238 patients with ulcerative colitis in remission will be randomly divided into     two groups.One will receive regular treatment,and the other group will receive extra oral     berberine 300 mg three times daily for a year.      The end of the study for every patient is disease recurrence(Mayo Clinic score of 3 points or     more ).      The primary analysis is annual recurrence rate, and both endoscopy and Mayo Clinic disease     activity index scores at the baseline and final assessments.   "
24710|NCT02962232|"     To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation     Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or     occlusion in below the knee artery.   "
24711|NCT02962219|"     The purpose of this feasibility study is to determine whether a structured exercise programme     prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological     measures of physical fitness above standard care.   "
24712|NCT02962206|"     Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency     department before casting. Standard of care currently requires that x-rays be performed     before and after fracture reduction, and inadequate reductions may be subject to repeat     attempts and are at a higher risk to require surgery. This study will assess the use of     point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the     angulation at the fracture site after a reduction is performed. If this angulation is     decreased, it would suggest that POCUS for distal radius fracture reduction could decrease     the number of failed reduction attempts and therefore the number of repeated reduction     attempts.   "
24713|NCT02962193|"     After bariatric surgery there are big changes in the daily functions, activities and social     participation of the patients.      This is a prospective study that examine daily performance and daily participation by     questionnaires, before and after bariatric surgery.   "
24714|NCT02962180|"     Actually the methods for melanocyte delivery are invasive and often sophisticated. The     dermarolling system with needles causing tiny microinjuries in the epidermis could offer a     minimally invasive and painless method of melanocyte transplantation. The purpose of the     study is to develop a new and simple method for transepidermally delivering keratinocytes and     melanocytes into vitiligo skin.   "
24715|NCT02962167|"     This is a two arm Phase I study within the Pacific Pediatric Neuro-Oncology Consortium     (PNOC).      This study will look to determine the safety and recommended phase 2 dose of the modified     measles virus (MV-NIS) in children and young adults with recurrent medulloblastoma or     atypical teratoid rhabdoid tumor (ATRT).   "
24716|NCT02962154|"     The purpose of project is to answer fundamental questions about the mechanisms underlying     mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and     to identify potential biomarkers and psychosocial risk factors associated with this     condition.      To achieve this goal, investigators will use cutting-edge cardiovascular and functional     neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory     setting in subjects recruited from four patient populations: 1) patients who recently     sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary     angiography (with and without known coronary artery disease); 3) patients with a diagnosis of     major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2     disorder.   "
24717|NCT02962141|"     To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon     Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for     the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.   "
24718|NCT02962128|"     A randomized, clinical trial to provide the first comprehensive investigation of the role of     fatty acid desaturate (FADS) genetic determinants on PUFA biosynthesis and metabolism as well     as levels of inflammatory markers in a controlled dietary environment using two (low and high     linoleic acid) parallel diets.   "
24719|NCT02962115|"     This study evaluates the feasibility of a clinical informatics system-based approach to lung     cancer screening. Patients of a large academic medical center who may qualify for lung cancer     screening will be sent an electronic invitation to complete an online lung cancer screening     decision aid.   "
24720|NCT02962102|"     The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and     calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney     injury (AKI) in critically ill patients.   "
24721|NCT02962089|"     Oral supplementation with branched chain amino acids (BCAA) increases the levels of     circulating BCAA, stimulates BCAA uptake in muscles, and decreases amino acid release from     muscle, eventually promoting muscle anabolism. However, uptake of oral BCAA by muscle is not     complete, pointing out that non-muscular tissues, as the splanchnic bed and gut microbiota,     may play a role in BCAA metabolism.      This protocol aims at studying the impact of protein-energy wasting (PEW) and of refeeding     with branched chain amino acids (BCAA), on gut barrier including gut microbiota, in chronic     hemodialysis (HD) patients. The investigators speculate that:        1. HD patients with PEW have altered composition and function of gut microbiota, increased          permeability of epithelial gut barrier, increased systemic inflammation but decreased          fecal immunoglobulin A (IgA), and a dysbalance of plasma appetite mediators in favor of          anorexigenic mediators, compared to HD patients without PEW, non dialyzed patients with          chronic kidney disease and well-nourished non obese subjects,        2. BCAA supplementation of HD patients with PEW reverses these changes, thereby improving          nutritional state, physical function, quality of life and resistance to infections.   "
24722|NCT02962076|"     Imaging is to be performed prior to procedure using positron emission tomography/ computed     tomography (PET/CT), after a special dye is injected. The scans are going to be merged with     other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.   "
24723|NCT02962063|"     The purpose of this study is to test the safety of adding a new drug, durvalumab (also called     MEDI4736), to chemoradiation using two standard chemotherapy drugs, carboplatin and     paclitaxel. The investigators want to find out what effects, good and/or bad, this     combination has on the patient and cancer.   "
25001|NCT02958436|"     The primary objective of this study is to evaluate the safety and tolerability of single     ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and     females   "
24724|NCT02962050|"     Individuals with Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment     (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and     aspiration pneumonia. These sequelae necessitate timely identification of at risk individuals     to ensure optimal management of oral intake and pulmonary function. The purpose of this study     is to evaluate the discriminant ability of several non-invasive screening tools at detecting     swallowing impairment in individuals with ALS.   "
24725|NCT02962037|"     The purpose of this study is to determine whether the known treatment for DSPS also improve     the cognitive ability and mood of the patients.   "
24726|NCT02962024|"     the investigators aim is to investigate and explore the effect 10 mg morphine added to local     anesthetics in serratus anterior plane block for post mastectomy pain management after     modified radical mastectomy in patients with breast cancer with assessment of its serum level     if it will be absorbed systemically or not?   "
24727|NCT02962011|"     This was an unblinded randomized controlled trial. Women were randomized to uterine closure     with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of     elective cesarean. The primary outcome was closure time of the uterine incision. Also     measured were blood loss during incision closure and the use of additional hemostatic     sutures. Informed consent was obtained   "
24728|NCT02961998|"     Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the     popularity of health examination, most patients were diagnosed as HCC in advanced stages so     far. Sorafenib is currently recognized worldwide as the only effective treatment for advanced     HCC. However, sorafenib need long-term medication, and will bring a series of side effects,     including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs swelling,     rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously affect patient's     quality of life.Besides, this side effects appeared to be dose-related.When severe HFS     happened, sorafenib need to reduce dosage or discontinue administration, which could     seriously affect the patient's survival. Therefore, investigators designed this prospective     randomized controlled study to explore preventive effect of celecoxib for sorafenib related     HFS, the influence on the quality of life in patients with, and also the synergistic     anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study will explore     horizon of improving treatment for sorafenib in patients with advanced HCC,quality of life     and tumor control.   "
24729|NCT02961985|"     The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the     treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to     provide current data on the implementation of guidelines for both, the interventional and     adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.   "
24730|NCT02961972|"     The present study aims at investigating the effects of the oral supplementation with creatine     on the systemic microvascular reactivity and plasma levels of homocysteine in vegetarian     individuals of the vegan type.   "
24754|NCT02961660|"     The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose     of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in     matched participants with normal renal function.   "
24777|NCT02961361|"     Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through     intravenous infusion，in order to improved the quality of block in regional anesthesia. In     this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed     with ropivacaine in coracoid approach brachial plexus block.   "
24731|NCT02961959|"     Background: Pelvic pain is common during pregnancy and usually subsides after delivery. Some     women, however, experience severe and long-standing pelvic pain, judged to emanate from the     Sacro-iliac joints (SI-joints). Radiological correlates are absent and there are diverging     opinions regarding the value of different clinical testing procedures and the use of     anaesthetic blocks to reveal SI-joint origin of the pain. In case of slight or moderate pain     the situation may be solved by the use of analgetics and physical therapy, but in case of     severe pain the situation might end up in a discussion whether surgery with arthrodesis of     the SI joint might be of value. To our knowledge, however, the results from surgical     treatment has not been compared with non-surgical treatment in a randomized study.      Aim: The investigators´ hypothesis is that        1. there exists a specific identifiable subgroup of patients within the chronic low back          pain (CLBP) group in whom the pain emanates from the sacro-iliac (SI) joints, and that        2. patients in this subgroup may be selected based on thorough symptom analysis, and        3. that arthrodesis of the actual joint/s may reduce the pelvic pain. Methods: A RCT with          parallel group design with pre- and post-treatment data. Inclusion of women 18-55 years          old with pronounced pelvic pain for at least 2 years and having tried ordinary physical          therapy without improvement and being on sick leave at least 50 percent. Operation by          posterior approach with bone transplantation between the iliac bone and the sacrum,          using microsurgical technique. Patients in both groups, the surgical (S) and          non-surgical (NS) were all treated by formal physiotherapy at a five days stay at the          Clinic and instructed to continue their training at home according to the lines given at          the Clinic.      Outcome: The primary outcome was perceived pelvic pain according to the assessments on the     validated Balanced Inventory for Spinal Disorders questionnaire (BIS) and on a Visual     Analogue Scale (VAS) before treatment and at follow-up one year after treatment. The     perceived change in pain was also assessed on a transitional scale in the follow-up version     of the BIS.      Secondary patient reported outcome measures (PROM) were pain related functions assessed on     the Oswestry Disability Index questionnaire (ODI), the BIS and the Roland-Morris     questionnaire. Health related quality of life was assessed by using the Short-Form 36 (SF-36)     and Euro-Quol (EQ-5D) questionnaires.   "
24732|NCT02961946|"     To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal     administration of Nitroglycerin. Aim of this prospective research study is to investigate     equivalence on image quality after sublingual or transdermal Nitroglycerin administration     (H0).      Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.   "
24733|NCT02961933|"     This study will determine rates of first pass success without hypoxemia in emergency     department intubations with and without the use of apneic oxygenation by nasal cannula.   "
24734|NCT02961920|"     The area of aesthesia-induced atelectasis is much larger in the obese compared with the     non-obese, but there may also be more airway closure and impaired matching of ventilation and     lung blood flow.      When an anesthetized patient is turned to the prone position, dynamic compliance (Cdyn)     decreases and peak airway pressure increases unless the abdomen hangs freely to prevent the     abdominal viscera from compromising the diaphragm movement. Although the Wilson frame is     designed to allow the abdomen to hang, it partially compresses the anterior abdominal wall     and therefore does not allow the abdomen to hang completely, especially in obese patients.      This in turn increases peak airway pressure and decreases Cdyn, oxygenation. This study aimed     to investigate the effects of a prolonged I:E ratio (i.e., 1:1) compared with the     conventional I:E ratio of 1:2 on respiratory mechanics and hemodynamics during spine surgery     in the prone position in obese patients.      We hypothesized that, compared with an I:E ratio of 1:2, a ratio of 1:1 improve oxygenation     without hemodynamic instability .   "
24759|NCT02961595|"     Enterovirus infections may either increase or decrease the risk of type 1 diabetes depending     on the age of infection and the type of enterovirus in question. This study evaluated whether     early serial exposures to three replication-competent enterovirus strains (live poliovirus     vaccine, OPV) can influence the immunity to other enteroviruses and the possible initiation     of autoantibodies e.g. islet autoimmunity in young genetically predisposed children.   "
24735|NCT02961907|"     Infertility is defined as the inability to conceive after 12 months of unprotected     intercourse, It affects approximately one in six couples pregnancy. Many lifestyle factors of     the couple's pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee,     drugs, exercise, stress, sleep, pollution...) are risk factors for infertility. Weight gain,     in both members of the couple, is associated with an increased risk of Assisted Reproduction     Technology (ART) failure and adverse pregnancy outcome, while healthy lifestyle makes the     risk of infertility three times less likely to happen. Idiopathic infertility may greatly     benefit from lifestyle factors optimization.   "
24736|NCT02961894|"     To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in     the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.      This Atherectomy system will be used on eligible patients with stenosis of at least 70%     diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and     the presence of any major adverse events (safety) for up to 30 days after the procedure.   "
24737|NCT02961881|"     Primary Objective:      • To evaluate the safety and tolerability of every 12 hours (q12h) and every 24 hours (q24h)     administration of subcutaneous (SC) blinatumomab      Secondary Objectives:        -  To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC          administrations        -  To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered          subcutaneously        -  To determine the incidence of anti-blinatumomab antibody formation following SC          administration        -  To evaluate efficacy response following treatment with SC blinatumomab administration      Exploratory Objective:        -  To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as          cytokine profiles during SC administration        -  To evaluate efficacy response following treatment with SC blinatumomab administration          using Lugano criteria   "
24738|NCT02961868|"     PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This     study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier:     NCT02884141), which aims to document phenotypic and genetic traits in patients with renal     and/or cervical artery fibromuscular dysplasia.   "
24739|NCT02961855|"     Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of     CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac,     referred as treatment B) in benign anorectal surgery.   "
24740|NCT02961842|"     The study will compare one technique of fluid administration (combined colloid preload and     crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery     performed under spinal anesthesia.   "
24775|NCT02961387|"     Investigators aim to study the effectiveness and safety of inhaling hydrogen-oxygen which     produced by a hydrogen generator with nebulizer to decreases inspiratory effort for the     patients with tracheal stenosis.   "
24741|NCT02961829|"     It is becoming clear that a combination of interventions will be desirable to achieve HIV     cure. Therefore the investigators propose a pilot proof of concept study, using combination     of a number of different interventions for eradicating residual plasma viremia and decreasing     HIV reservoirs. The investigators hypothesize that, (i) antiretroviral intensification using     Maraviroc, and/or dolutegravir with (ii) Dendritic Cell vaccination using autologous HIV, and     (iii) purging intervention using the Class III HDACs, Sirtuin-1, and (iv) decreasing the     ratio of long-lived central memory (TCM)/transitional memory (TTM) CD4+ T-cells using     Auranofin will provide a synergistic impact leading to a sterilizing cure of HIV infection.     Results of this study may provide insightful evidence for planning the next steps using the     more efficacious combination of intervention strategies towards HIV sterilizing cure.   "
24742|NCT02961816|"     The goal of this clinical research study is to learn about the safety and effectiveness of     the combination of panobinostat, gemcitabine, busulfan, and melphalan, either with or without     rituximab, in patients who have non-Hodgkin's or Hodgkin's lymphoma and are receiving a stem     cell transplant.   "
24743|NCT02961803|"     The primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day     over placebo in the clinical improvement (walking tests) of patients with     adrenomyeloneuropathy   "
24744|NCT02961790|"     This randomized phase III trial studies how well oxybutynin chloride works in managing hot     flashes in patients who are not candidates for, or not interested in hormone replacement     therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes,     however doses used in prior studies have resulted in side effects. This trial is evaluating     lower doses of oxybutynin with the goal of determining if they are efficacious with less side     effects.   "
24745|NCT02961777|"     Cardiovascular diseases, and more precisely patients with ST - elevated myocardial infarction     are globally responsible for a large number of hospitalizations and deaths. Monitoring the     quality of care for these patients is very relevant topic. Investigators developed indicators     from the scientific literature on the quality of care for patients with STEMI at both the     patient level and hospital level. The indicators were subsequently validated by a RAND     modified Delphi - study of multidisciplinary experts in the care of patients with STEMI.      In this study, the following objectives are set:        1. ) Study of the quality of care for patients with STEMI in 16 Flemish hospitals with          cardiology department by retrospective and prospective audit of 20 patient records per          participating hospital .        2. ) Study of the interdisciplinary relationships and communication within teams involved          in the care of patients with STEMI in the participating hospitals 3) Study of perceived          organization of care for patients with STEMI in the participating hospitals      In accordance with the objectives of the research, the study consists of three phases:        1. ) A retrospective observational audit of 20 patient records of patients with STEMI each          participating hospital.        2. ) A prospective observational audit of 20 patient records of patients with STEMI each          participating hospital.        3. ) A survey using validated instruments of interdisciplinary relationships and          communication on the one hand and on the other by the teams involved in the care of          patients with STEMI perceived organization of care .      Data collection is performed by local researchers and remains their property. The data is     coded and kept confidential. Only the local researcher has access to the encryption key. The     data are protected by the Belgian law on privacy and medical confidentiality, only to be used     in the context of this study. The results are published anonymously.   "
24746|NCT02961764|"     This study will evaluate a new critical pathway (use of guideline-based patient     identification criteria and for those who meet these criteria, use of dalbavancin) for the     treatment of ABSSSI compared to usual care.   "
24747|NCT02961751|"     Data from this clinical study will be used to assess if the treatment approach meets CDC     criteria for becoming a recommended treatment (cure rate greater than 95 percent with a lower     CI:95percent greater than 95 percent) or alternative treatment (cure rate greater than 95     percent with a lower CI95 percent greater than 90 percent) for uncomplicated gonococcal     infection. An estimated cure rate of 0.98. A single-arm clinical study design, allowing for a     10 percent subject drop-out rate and 10 percent non-evaluable rate. Screening Visit will     include a NG NAAT; the Baseline Visit at Day 1 will include a NG NAAT and culture; Test of     Cure Visit at Day 6 will include a NG NAAT and culture. The primary objective of this study     is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae     infections with gyrA serine 91 genotype.   "
24748|NCT02961738|"     Narrative reformulation (NR) is an active ingredient of cognitive analytic therapy (CAT)     which is assumed to increase engagement and improve outcomes. This trial sought to test these     claims. A randomized and controlled dismantling trial method has been designed to investigate     treatments outcomes for depressed patients receiving CAT in an Improving Access to     Psychological Therapies service. Participants will be randomized to either treatment as usual     (full-CAT) or CAT minus narrative reformulation (CAT-NR). The primary outcome measure is the     Patient Health Questionnaire (PHQ-9), with secondary outcome measures of anxiety,     functioning, helpfulness and the alliance. Outcomes will be assessed at screening, every     treatment session and at 8-weeks follow-up. The trial will enable as assessment of the     utility of NR during CAT. and whether CAT appears suitable for treating depression in Primary     Care.   "
24749|NCT02961725|"     Bronchopleural fistula (BF), an abnormal passage or communication between a bronchus and     another part of the body, may develop when there are penetrating wounds of the thorax and     after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high     rate of mortality and teratogenicity.      The investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells     to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to     investigate the application of umbilical cord mesenchymal stem cells in the treatment of     bronchopleural fistula.   "
24750|NCT02961712|"     HTLV-1 Associated Myelopathy is a chronic disease of the spinal cord, caused by a virus     called human T lymphotropic virus type 1（HTLV−1）. Natural Killer cells provide rapid     responses to viral-infected cells, acting at around 3 days after infection, and respond to     tumor formation. In this trial, the investigators aim to study the therapeutic safety and the     effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the     disease and should lead to better therapy.   "
24751|NCT02961699|"     This is a prospective, randomized, single-site, safety and efficacy study of subjects with     chronic venous stasis ulcers. Patients will fall into two categories: treatment arm (24     subjects) and non-treatment or control arm (12 subjects). The treatment group will undergo a     small liposuction procedure and receive placement of autologous cell therapy (stromal     vascular fraction or SVF) injected around the rim of venous stasis wound     (subcutaneously)following standard wound debridement, with saturation of collagen dressing     material with standard over-dressing. Control (non-treatment) subjects will receive     debridement and dressing changes as per standard of care without SVF.   "
24752|NCT02961686|"     The trial is to describe quality of life in patients affected by prostate cancer treated with     exclusive radiotherapy and submitted to psychological and andrologic evaluation.   "
24755|NCT02961647|"     The preferred treatment of organic mitral regurgitation (MR) is mitral valve repair.     Optimally this should be timed so late that it commensurate with the risk of surgery and     before irreversibly damage of the heart and pulmonary vessels. The aim is to obtain an     understanding of the differences between the symptomatic and asymptomatic patient.      The study will test      A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke work     during physical strain compared with asymptomatic MR.      B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1     year after mitral valve repair.      C: Filling pressure can be estimated non-invasively by echocardiography. To test this 40     patients with asymptomatic MR and 40 symptomatic will undergo a stress echocardiography with     simultaneous echocardiography and invasive measurement of central hemodynamics. In addition a     pulmonary function test and cardiac MRI will be performed.   "
24756|NCT02961634|"     Single-center study, single blind, comparative with the objective of evaluating the efficacy     and safety of an investigational product as an adjunct in the treatment of onychomycosis     improvement of 90 days ± 2 days.   "
24757|NCT02961621|"     Emergency call centers across the country are preparing for the Next Generation 911 (NG911)     initiative, which will allow citizens to place 9-1-1 calls using digital technologies such     as text messaging, email, Skype or instant messaging, and will expand emergency information     sources to also include streaming video, photo uploads, and automatic crash notifications.     The impact of these new information and communication technologies on those tasked with using     them in time-sensitive emergency situations is unknown. Our study is designed to address the     following hypotheses: 1) We hypothesize that NG911 implementation will have a significant     effect on telecommunicator stress levels and 2) A resiliency training tailored to the needs     of telecommunicators will mitigate the impact on NG911 implementation on stress levels. We     will test these hypotheses through the following specific aims:      Aim 1: Measure levels of stress, job satisfaction and job performance among 9-1-1     telecommunicators before and after the NG911 implementation.      Aim 2: Develop and test the efficacy of an evidence-based resiliency training and worker     support intervention to improve psychological well-being and job performance of 9-1-1     telecommunicators.      Aim 3: Build an ABM tool of 9-1-1 call centers to improve 9-1-1 telecommunicator workforce     training and smooth transitions to future call center innovations.   "
24758|NCT02961608|"     LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing.     Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules and     no new safety concerns.        -  Stable kidney transplant patients can be safely converted from Adoport® twice-daily to          LCP-Tacro®.        -  The greater bioavailability of LCP-Tacro after once-daily dosing results in similar          (AUC) exposure, at a dose approximately 30% less, than the total daily dose of Adoport®.        -  LCP-Tacro provides a slow drug release and this results in flatter kinetics          characterized by significantly lower peak-trough fluctuations.        -  CN is the major cellular target of the calcineurin inhibitors (CNIs) cyclosporine A          (CsA) and tacrolimus. The ability of these drugs to inhibit CN activity is dependent on          their binding to the respective immunophilins, cyclophilins A and B for CsA and FKBP12          for tacrolimus.        -  CN inhibition is a rate limiting phenomenon. Over concentrations of tacrolimus does not          correlate with an increase in the CN activity.   "
24760|NCT02961582|"     Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral     neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit)     constipation is of suboptimal quality. Furthermore, there is no estimate of costs and     cost-effectiveness in this patient group.      Objective: The main objective of this study is to assess the effectiveness of SNM compared to     personalized conservative treatment (PCT), in patients with idiopathic slow-transit     constipation who are refractory to conservative treatment. The secondary objectives are     assessing the 1) costs, 2) cost-effectiveness and 3) budget-impact of SNM compared to PCT.      Hypothesis: Based on previous research we hypothesize that SNM will be more effective than     PCT in terms of a significantly higher proportion of patients having treatment success at 6     months.      Study design: An open-label pragmatic randomized controlled trial (RCT) combined with a     prospective cohort study.      Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic     slow-transit constipation refractory to conservative treatment.      Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of     two phases. In the screening phase an electrode is inserted near the third sacral nerve and     connected to an external stimulator. If the screening phase is successful (average defecation     frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the     buttocks of the patient. If not successful, patients receive conservative treatment. The     control intervention is PCT. This is the best and least invasive alternative to SNM. PCT     consists of medication and/or retrograde colonic irrigation.      Main study parameters/endpoints: The primary outcome is success at 6 months, defined as an     average DF of ≥3 a week according to a 3-week defecation diary. Secondary outcomes are     straining, sense of incomplete evacuation, constipation severity, fatigue, constipation     specific and generic (health-related) quality of life ((HR)QOL), and costs at 6 months.     Furthermore, cost-effectiveness and budget-impact will be estimated.   "
24761|NCT02961569|"     Tuberculosis (TB) is a major cause of death among the communicable diseases in the world.     Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier     diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission. The aim     of the study will be to compare two strategies, in patients with a chest-X-ray in favour of     contagious pulmonary TB: the classical strategy of sputa collection during three consecutive     early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2     during the first early morning.   "
24762|NCT02961556|"     This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of     AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation.     The safety and efficacy of 12 weeks of administration will also be evaluated.   "
24763|NCT02961543|"     A randomized clinical trial involving 30 individuals submitted to ACL reconstruction will be     conducted.      Participants will be randomized into: Group I, submitted to a muscular rehabilitation program     based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation     program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation     protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema     reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation     programs based on eccentric isotonic and isokinetic exercise will begin 45 days after ACL     reconstruction. The programs will last six weeks, with training frequency of two sessions per     week, separated by a minimum interval of 72 hours.   "
24776|NCT02961374|"     This phase II trial studies the side effects of erlotinib hydrochloride and how well it works     in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of     developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
24764|NCT02961530|"     A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be     conducted.      Participants will be randomized into: Group I, submitted to a muscular rehabilitation program     based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation     program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation     protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema     reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation     programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial     menisectomy. The programs will last six weeks, with training frequency of two sessions per     week, separated by a minimum interval of 72 hours.   "
24765|NCT02961517|"     Questionnaire study to investigate the effect of individual characteristics such as age, sex,     ethnicity, educational level and socioeconomic status on the preferred format of patient     education delivery, for patients with diabetes and/or cardiovascular disease   "
24766|NCT02961504|"     The primary objectives of this study is to evaluate the efficacy of HLCM051 on functional     outcome in subjects with acute ischemic stroke and to evaluate the safety of HLCM051 in     subjects with acute ischemic stroke.   "
24767|NCT02961491|"     The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane     I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid     malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).   "
24768|NCT02961478|"     IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated     by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure     episode.   "
24769|NCT02961465|"     Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral     neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit)     constipation is of suboptimal quality. Furthermore, there is no estimate of costs and     cost-effectiveness in this patient group.      Study design: A prospective cohort study with one group. This study is conducted next to a     randomized controlled clinical trial (RCT) on 'the effectiveness and cost-effectiveness of     sacral neuromodulation in patients with idiopathic slow-transit constipation refractory to     conservative treatments' (for more information ClinicalTrial.gov ID: NCT02961582). This RCT     is part of a temporary reimbursement arrangement, called conditional reimbursement of health     care (in Dutch: Voorwaardelijke Toelating) of the National Health Care Institute     (Zorginstituut Nederland). As part of this arrangement, the Ministry of Health, Welfare and     Sports requires that SNM remains available for eligible patients during the conditional     reimbursement period, also when inclusion of the RCT has ended. Furthermore, the Ministry     requires that patients who received personalized conservative treatment in the RCT (control     group), are offered SNM after completion of their follow-up of 6 months. As a result, the     National Health Care Institute requires that the patients who receive SNM outside the RCT are     included in a prospective cohort study to be able to collect data on them.      Aim: The aim of this prospective cohort study is to collect more (but uncontrolled)     information regarding the safety and effectiveness of SNM.      Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic     slow-transit constipation refractory to conservative treatment.      Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of     two phases. In the screening phase an electrode is inserted near the third sacral nerve and     connected to an external stimulator. If the screening phase is successful (average defecation     frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the     buttocks of the patient. If not successful, the pacemaker will be removed and patients     receive conservative treatment.      Main study parameters/endpoints: The primary outcome is treatment success at 6 months,     defined as an average DF of ≥3 a week according to a 3-week defecation diary and safety.     Secondary outcomes are straining, sense of incomplete evacuation, constipation severity and     generic (health-related) quality of life ((HR)QOL).   "
24783|NCT02961283|"     The study is divided into two parts. The first part of the study will test various doses of     ASN003 to find out the highest safe dose to test in three specific groups.      The second part of the study will test how well ASN003 can control cancer. Subjects will be     enrolled into one of three groups.      Group 1: metastatic or recurrent melanoma with documented BRAFV600 mutation (n=20 evaluable     patients) Group 2: metastatic colorectal cancer (CRC), or advanced non-small cell lung cancer     (NSCLC) with documented BRAFV600 mutation (n=14 evaluable patients) Group 3: advanced solid     tumors with documented PI3K pathway alterations (PIK3CA mutation or PTEN loss) (n=14     evaluable patients)   "
24770|NCT02961452|"     Peanut allergy (PA) has been well studied and its prevalence was estimated up to 1.3% in     Europe. Tree nut (TN) allergy and PA are clinically similar and often coexist, TN allergy     prevalence ranged from 0.05 to 4.9 %. TN allergy is longlasting and nearly all TN have been     associated with fatal allergic reactions . Other legumes or TN also contain seed storage     protein orthologs of the globulins (Ara h1, Ara h 3) and 2S albumins (Ara h 2) of peanut,     susceptible to provoke allergic reactions, but cross-reactivity to TN and other legumes in PA     patients could also appear through primarily sensitization. These possible IgE-binding     cross-reactions bring to recommend the avoidance of TN and other legumes which have never     been eaten in PA children. In this context, diagnosis work-up of relevant cross-allergy     versus asymptomatic cross-sensitization will impact directly children's health-related     quality of life (HRQL).      When physicians suspect food allergy, many parameters have to be considered, such as clinical     background, clinical history, type of symptoms related to the suspected food and     cross-allergy to other foods. Then, to objectively confirm a food allergy and to assess its     severity (related to the threshold reactive dose and symptoms), an oral food challenge (OFC)     is demanded, and double-blind placebo-controlled food challenge (DBPCFC) is considered as     the gold standard.      Although OFC are more and more available in the diagnosis of PA, the assessment of     cross-allergy to every single allergenic TN and legumes requires full allergy work-up and     often many years of follow-up. Few studies investigated cross-allergy to TN and other legume,     with rates of cross-allergy to TN between 28% and 50%. However, targeting patients with     severe or cross-allergic phenotypes would greatly assist the allergist in management and     follow-up of PA patients (i.e., planning OFC to cross-reactive food).      Our main objective is to identify different disease phenotypes of PA children with cluster     analysis. This statistical approach has never been performed to identify cross-allergic     phenotypes. We also will describe cross-allergy in PA and will identify possible risk factors     for cross-allergy to TN and other legumes in PA children.   "
24771|NCT02961439|"     The use of echocardiography in intensive care is a developing field. In expert hands     echocardiography has proven its utility in diagnosing cardiac pathology, differentiating     shock states and in haemodynamic monitoring. However, whether the results obtained by experts     can be generalized to trainees or specialists with limited training remains unclear. Further,     concerns around training time and cost for intensive care staff have been a factor in     limiting the uptake of echocardiography in intensive care.      The investigators aim to assess the diagnostic accuracy of Australian ICU doctors in training     after completion of the current minimum training. After completing a structured teaching     program and 30 mentored training scans trainees will be assessed on their accuracy with     echocardiography. In the research phase trainees will complete a further 40 scans with each     one matched with an expect scan. The results from the expert and trainee scans will be     compared to determine the trainee's accuracy.   "
24772|NCT02961426|"     This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety,     tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV     infection.   "
24774|NCT02961400|"     A drop off in improvement over the months and years after treatment is common. One     contributor may be poor memory for the contents of treatment. This study seeks to determine     whether text messages containing reminders of the content of sessions will improve treatment     outcomes.   "
24778|NCT02961348|"     This study will compare early with late start of treatment with Non-vitamin K oral     anticoagulation (NOAC) in adult patients with acute ischemic stroke and atrial fibrillation;     it is a registry-based randomized clinical trial (R-RCT) using The Swedish Stroke Register     (Riksstroke). Half of the patients will start NOAC early (within 4 days after stroke onset)     while the other half will start late (5-10 days after stroke onset).   "
24779|NCT02961335|"     Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that     affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of     DPLD is often challenging, because of the large number of pathological entities involved,     which share close clinical and radiological presentations. High resolution Chest CT, a key     diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations,     so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling.     This invasive procedure is not devoid of morbidity and may be impossible to perform in     fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a     multi-disciplinary expert consensus, based on careful medical history, chest CT and     bronchoalveolar lavage examinations.      Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic     technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy     performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric     clinical trial at the Rouen University Hospital in more than 200 patients and healthy     volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and     confirmed the safety of the technique.   "
24780|NCT02961322|"     This is a study of health economics longitudinal cohort on the evaluation of direct medical     cost of a surgical technique based on the use of an innovative device (the da Vinci® surgical     robot Si) and its comprehensive care.   "
24781|NCT02961309|"     The objective of the proposed research is to investigate how smoking increasing potency of     THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking     behavior, urges, subjective effects, and abuse liability. This study will be a     within-subjects, placebo-controlled study in our clinical laboratory of the effect of active     vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective     effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.   "
24782|NCT02961296|"     The purpose of this study is to make nationwide registry for antimicrobial resistance of     Helicobacter pylori using single method with agar dilution in Korea.   "
24785|NCT02961257|"     The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or     neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of     cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 70 years) with     mCRPC previously treated with a docetaxel-containing regimen.   "
24786|NCT02961244|"     Aim of this study is to investigate the efficiency of a standard normothermia protocol and     effects on postoperative Surgical Site Infection (SSI) rate.   "
24787|NCT02961231|"     The cost of pneumococcal conjugate vaccine use can be greatly reduced by making use of     existing herd immunity to protect children against vaccine type pneumococci. The     investigators will reduce the circulation of vaccine type pneumococci to low levels by PCV     catch-up campaign; vaccinating all children less than 3 years of age with PCV, after which     the investigators will evaluate the ability of a simplified two doses regimen and an     alternative one dose regimen to prevent the reintroduction of vaccine type pneumococci     compared to the WHO recommended 2 doses schedule.   "
24788|NCT02961218|"     To determine the effect of canakinumab versus placebo on daily pain experienced by sickle     cell anemia patients (Reduction of average daily pain VAS over the period of Week 8 to 12 as     compared to baseline levels).   "
24789|NCT02961205|"     This randomized controlled pilot study evaluates the use of oral nutritional supplementation     in nutritionally at-risk cardiovascular surgery patients. The oral nutrition supplement is     given for 30 days prior to surgery, continuing throughout their surgical hospitalization and     ends at hospital discharge. Half of the participants will receive the oral nutritional     supplement and the other half will not.   "
24790|NCT02961192|"     In this study, we will conduct a one-year, four-arm, randomized, controlled trial to compare     three social incentive-based gamification interventions to control for promoting physical     activity and weight loss toward improved glycemic control among type 2 diabetics.   "
24791|NCT02961179|"     This study will investigate the in-depth the benefits of dairy consumption on glucose     metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so,     33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study     including a 6-week intensive dairy product consumption period and a 6-week dietary     counselling period.   "
24792|NCT02961166|"     57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal membrane     oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received     IgM-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.      These patients were analyzed regarding length of stay in intensive care unit (LOS ICU),     length of stay (LOS) in hospital and regarding mortality.   "
24793|NCT02961153|"     With the development of national economy and medical technology, patients can extend life     rely on high-end medical facilities. At the same time, the continued treatment cannot bring     benefits to children, even resulting in poor quality of life of children and bringing high     medical costs. This makes the limited medical resources are unreasonable distributed.     Research showed that PICU mortality rate halved over ten years ago, but the data did not     include death cases who left hospital before death. However, the death number of out-hospital     were more than death in-hospital. Therefore, the data cannot actually reflect China's     mortality rate of PICU. The reason analysis was limited to the cause of the disease, and does     not take the social, economic factors into account. This study include eight PICUs of     children's Hospital PICU. Critically ill patients are prospectively studied from death risk     factors, admission status, disease diagnosis, severity of illness, analyzing of the risk     factors of death from disease diagnosis and death risk factors. In addition, we will     illuminate the relationship of death and economic factor, especially for who died     out-hospital after withdraw or stop treatment.   "
24794|NCT02961140|"     Anesthetic management and fluid therapy is crucial in esophageal resection and     reconstruction, which is associated with high incidence of postoperative morbidity and     mortality. This study aims to investigate the effect of goal directed fluid management on the     postoperative outcome of esophageal resection and reconstruction.   "
24795|NCT02961127|"     The cases were hospitalized patients from two medical centers in Beijing and Harbin     respectively. Venous blood was collected by standard vein puncture in fasting condition.   "
24796|NCT02961114|"     Benign prostate hypertrophy (BPH) and inflammation are common non-cancerous enlargement of     the prostate, which result in urinary interference and incomplete drainage of the bladder.     Compression of the urethra is common cause of such resistance of full draining, and may over     time result in progressive hypertrophy, instability, urgency, nocturia and weakness of the     bladder musculature.      Prostatic growth frequently begins in the 30s, and it is estimated that 50% of all males have     benign enlargement leading to 75% by age 80. BPH and low grade inflammation is one of the ten     most prominent and costly disorders in males over 50.      Urinary tract symptoms are divided into issues of storage, voiding, and post-void symptoms     can be associated with bladder outlet obstruction (BOO).      This study utilizes isolation of adipose-derived stem/stromal cellular stromal vascular     fraction (AD-cSVF) deployed as an IV suspension in sterile Normal Saline (500cc). Due to the     anti-inflammatory and immunomodulatory effects common to AD-cSVF are tested in relief of the     inflammatory elements and the concurrent hypertrophy in BPH. Early pilot use has suggested a     positive effect on these issues, and have relieved much of the incomplete voiding, pain,     nocturia, delay in starting/stopping urination, and increased urgency and frequency.      Lipoharvesting of Adipose-Derived tissue stromal vascular fraction (AD-tSVF) is now a common     closed access to subdermal adipose stromal/stem cell population consisting of both stem and     stromal cells, each of which are felt to contribute a wide variety of effects and potentials.     Closed, sterile isolation of the AD-cSVF is possible with advent of closed systems to     enzymatically release these cells from the actual matrix (scaffolding) within the adipose     tissue complex (ATC). This group of largely un-designated cell population is isolated and     concentrated via a standard gradient layer separation by centrifugation. This cellular     isolate is then suspended in an IV of 500 cc Normal Saline and reintroduced to the patient.      This study is examining the clinical safety and efficacy of this approach, as well as     tracking the duration of effects and establish a therapeutic interval.   "
24797|NCT02961101|"     The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1     antibody in combination with low-dose decitabine in patients with relapsed or refractory     malignancies, including Non-Hodgkin'lymphoma, anti-PD-1-resistant Hodgkin'lymphoma,     gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung     cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.   "
24872|NCT02960113|"     The purpose of this study is to compare the effectiveness of reducing intra-cesarean section     nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch     with acupressure point P6 stimulation versus subjects that receive just scopolamine patch     versus subjects that receive just acupressure point P6 stimulation.   "
24798|NCT02961088|"     Pasta is an important example of a food which can lower the glycemic index (GI) of the diet,     a property that has been exploited extensively in studies of low GI dietary patterns.     Although low-GI dietary patterns have been shown to improve body weight, glycemic control and     blood lipids, it is unclear whether pasta as part of low-GI dietary patterns will improve     measures of global adiposity including body weight. The lack of high quality knowledge     syntheses to support evidence-based dietary guidance of the cardiometabolic benefits of pasta     represents an urgent call for stronger evidence. To improve evidence-based guidance for pasta     recommendations, the investigators propose to conduct a systematic review and meta-analysis     of controlled studies in humans to assess the effect of eating pasta as part of a low GI diet     compared to other diets on measures of adiposity (body fatness) in humans. The systematic     review process allows the combining of the results from many studies in order to arrive at a     pooled estimate, similar to a weighted average, of the true effect. The investigators will be     able to explore whether eating pasta as part of a low GI diet has different effects between     men and women, in different age groups and in people with high or normal sugar. The findings     of this proposed knowledge synthesis will help improve the health of Canadians through     informing recommendations for the general public, as well as those at risk of heart disease     and diabetes.   "
24799|NCT02961075|"     Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study   "
24800|NCT02961062|"     The purpose of this study is to determine if SAF312 eye drops have an adequate safety and     efficacy profile to justify further clinical development for the treatment of ocular pain     associated with corneal epithelial defect such as after photorefractive keratectomy (PRK)     surgery   "
24801|NCT02961049|"     The aim of this study is through a randomized clinical trial, double blind, splith-mouth,     evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The     presence of gingival displacement with a retraction cord (yes or no) and the category of     adhesive system (etch-and-rise and self-etching) will be evaluated. Data will be collected,     tabulated and submitted to statistical analysis.   "
24802|NCT02961036|"     Questionnaires are frequently used in online research, however recruiting, and completion     rates of online participants from a variety of cultures and demographic backgrounds can be     challenging. The challenge is greater in an online cohort because there is no way to observe     the participant beyond what is contributed online. Poor recruiting and completion can result     in underpowered research that may not be representative of the sample population. This can     trigger an increase in costs as the recruitment period may have to be extended until sample     size is reached. When recruiting and completion rates are inadequate studies may have to be     terminated and the answer to the research question can remain unknown.      To mitigate these challenges, incentives may be offered in the form of gift certificate     draws. There is uncertainty about whether this strategy is effective in online research and     if the value of the incentive alters the outcome. A randomised trial can be used to test the     intervention to establish an evidence base.      This study (SupMatQT) proposes to link with a large 20,000 person international cohort study     (SupMat) that will test the utility and preferences of journal supplementary materials for     reviewers, authors,and readers. The research described here will examine the evidence of     effect for offering a prize draw incentive on rates of recruitment, and completion for     consented participants. All participants will be entered in the draw. Information about the     value of the incentive of a prize draw will differ according to what group a participant is     randomized to. The entry in the prize draw will not be conditional on levels of participation     or group allocation.      The other question researchers will address is what effect do survey reminders have on     outcomes? All non-responders will be sent an initial reminder to complete the survey (Group     A) and for those who have still not responded a second reminder will be sent 14 days later     (Group B). Outcomes will be compared at three time points: for initial response, following     reminder 1(Group A), and following reminder 2 (Group B).   "
24827|NCT02960711|"     Phase III randomized controlled trial on men and women with Metabolic syndrome (MetS) to test     the hypothesis that comprehensive life-style changes and/or metformin treatment prevent     age-related chronic non-communicable diseases (ArCD).      The aim of the present study is to evaluate the effect of a comprehensive life-style     intervention (including moderate physical activity and Mediterranean/macrobiotic diet with     moderate calorie and protein restriction), and of treatment with Metformin (a calorie     restriction mimetic drug) for the prevention of ArCD.   "
24803|NCT02961023|"     Exercise capacity (EC) is limited in pulmonary arterial hypertension (PAH) by impaired right     ventricular (RV) function and inability to increase stroke volume (SV). Disease targeted     therapy, increases EC by improving SV. Additional factors may contribute to exercise     limitation:        -  Peripheral and respiratory muscle dysfunction        -  Autonomic dysfunction        -  An altered profile of inflammation        -  Mitochondrial dysfunction.      The enhancement of EC achieved pharmacologically may therefore be limited. Exercise training     in PAH improves EC and quality of life (QOL). The changes in physiology responsible for this     improvement are not clear. Patients with PAH stable on optimal oral therapy, but not meeting     treatment goals, will be enrolled in a 30-week randomised exercise training program.      One arm will undertake training for 15 weeks (3 weeks residential, 12 outpatient), the other     will receive standard care for 15 weeks then 15 weeks training.      Aims:        1. Demonstrate that exercise training can enhance EC and QOL when added to optimal drug          therapy a UK PAH population.        2. Explore mechanisms of exercise limitation and factors that improve with training,          assessing:             -  Cardiac function             -  Skeletal muscle function             -  Autonomic function             -  Respiratory muscle strength             -  Serum and muscle profile of inflammation      Primary outcomes (15 weeks)        1. 6 minute walk distance        2. QOL        3. RV ejection fraction   "
24804|NCT02961010|"     This study evaluates the effectiveness of Keeping Safe, a whole school preventative education     intervention in improving children's knowledge and understanding to keep safe in situations     of abuse. The intervention        -  Comprises three themes (1) Healthy Relationships; (2) My Body; and (3) Being Safe and          includes content across the following keeping safe concepts; bullying, neglect,          emotional, physical, domestic and sexual abuse, in online and offline contexts.        -  Includes activities for the formal and informal school curricula - 63 lessons will be          taught to children by their classroom teacher; 3 per term, 9 per year across 7 years          from Primary 1 to primary 7 (age 4-11 years).        -  Each lesson is accompanied by directed homework activities to involve and engage parents          and enable them reinforce learning at home. A number of whole school, key stage and year          group assemblies have also been prepared.        -  At the beginning of each term school leaders will deliver a prepared assembly to          introduce the theme for the term. Following this assembly each teacher will deliver 3          lessons tailored to the age group of their class and parents will assist with home          works. The lessons use eBooks, character animations, stories, rhymes, and interactive          whiteboard activities to engage children in their learning.      The intervention adopts a whole-school approach and seeks to build the capacity and skills of     teachers and parents as key partners. Teachers will receive a comprehensive package of     training, ongoing support and resource materials to equip them with the skills they need to     effectively communicate sensitive keeping safe messages. Parents will also receive a package     of resources to help them feel confident about communicating sensitive messages to their     children.   "
25057|NCT02957708|"     This study examines the effect of combining modified constraint-induced movement therapy     (mCIMT) and self-regulation (SR) in promoting upper limb function of children with hemiplegic     cerebral palsy (CP) studying in a school-based setting.   "
24806|NCT02960984|"     In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been     shown to exhibit a number of life-altering problems such as fatigue, limb weakness,     alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These     problems affect performance of many daily living activities (ADL) such as dressing, bathing,     self-care, and writing, thus reducing functional independence and self-rated quality of life.      Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a     combination of aerobic training and upper limb task-oriented training.      The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on     upper limb performance and on fatigue in People with Multiple Sclerosis.   "
24807|NCT02960971|"     To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging     from molecular pathways to societal impacts.   "
24808|NCT02960958|"     The aim of this study is to investigate discriminant metabolites in urine from patients with     rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's     metabolic fingerprint could predict the development or flare-up of RA.   "
24809|NCT02960945|"     This study will assess the metabolite and pharmacokinetic (PK) profile of a single dose of     CTP-543 compared to a single dose of Jakafi® in healthy volunteers.   "
24810|NCT02960932|"     Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three     at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on     the cerebral palsy, characterised by a modification of the structure (volume decrease) and     the elasticity (increase of the passive stiffness). Every alterations of the muscular     property have impact clinic and functional important. The many treatments of orthopaedic     targeting (lengthening of cast, injections of botulinic toxin), repeated to a multiple     recovery during the growth influences the muscular characteristics. There is a real interest     to measure the muscular property development during children's growth.   "
24811|NCT02960919|"     This is a prospective observational study assessing the clinical outcomes of children 2 to 59     months of age with both pneumonia and other co-morbidities presenting to a tertiary hospital     outpatient setting in Malawi, Africa who are most at risk for mortality or have other     complications and thus, are typically excluded from childhood pneumonia studies.   "
24812|NCT02960906|"     Disease and Stage: naïve metastatic kidney cancer.      A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or     VEGFR tKi in naïve metastatic Kidney cancer   "
24813|NCT02960893|"     The purpose of this study is to compare the efficacy of BHV-4157 versus placebo on ataxia     symptoms in subjects with spinocerebellar ataxia (SCA).   "
24814|NCT02960880|"     The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban     prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.   "
24834|NCT02960620|"     This is not a research study. The purpose is to provide supervised access to TheraSphere®     therapy at this institution.   "
24835|NCT02960607|"     The purpose of this study is to investigate whether high-dose icotinib treatment beyond     disease progression is beneficial for NSCLC patients who have EGFR mutation and who have     responded to EGFR TKI.   "
24815|NCT02960867|"     Acute kidney injury (AKI) is a frequent clinical condition in hospitalized, in particular, in     critically ill children. Moreover, AKI is an independent predictor of mortality. An incidence     of AKI in pediatric intensive care units (PICU) between 10 and 62% has been reported in     recent clinical trials adopting pRIFLE or AKIN criteria, with the highest risk present in     cardiac surgery patients. Despite significant developments in the management of AKI, the     overall mortality rate of patients with AKI has not improved significantly. Currently, there     is no consensus concerning the optimum dialysis modalities to adopt in pediatric AKI. No     studies have prospectively compared the efficacy of different types of RRT for pediatric AKI.     While PD remains the most commonly used modality in children worldwide, over the last decade     CRRT has become the preferred treatment modality for critically ill children with AKI in     North America.      The investigators have recently conducted a survey among 34 European Pediatric Nephrology     Centers in the ESCAPE Network to obtain current information on dialysis management practices     in children. Approximately 900 children with AKI requiring dialysis are managed at these 34     centers per year. This number supports the creation of a prospective European AKI registry.   "
24816|NCT02960854|"     A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in     participants with severe sepsis or septic shock.   "
24817|NCT02960841|"     The aim of this study was to determine the effectiveness of Intracavitary Manual Lymphatic     Drainage (IMLD) in the reduction of the perineal trauma and the symptoms of vaginal edema,     the prevention of complications during the expulsive and the improvement in the postpartum     recovery, compared to conventional treatment during the gestation, in women with the second     partum. The weekly treatment is performed from the 25th gestational week in women with vulvar     edema.   "
24818|NCT02960828|"     This study aims to validate the efficacy and safety of subthreshold laser photocoagulation on     high-risk macular drusen in early age-related macular degeneration which has a high risk of     conversion to exudative AMD.   "
24841|NCT02960529|"     Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic     high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since     laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly     performed hernia repair in children. The conventional approach this is done with2small     trocars to 1trocar . however the wound complications of infection and pain and the recurrent     rate have not been resolved. The aim of the study was to described a new way of     extra-peritoneal high ligation of hernia sac. This method combines the single-port     laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia     repair in children. The investigators hoped that this study will prove that the     extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as     the conventional technique in the cure of inguinal hernia and may results in lower recurrence     and reduce incidence of wound complications.   "
24819|NCT02960815|"     In this open label, single centre, pilot randomized controlled clinical trial the     investigators aim to compare the immunogenicity and safety of a new influenza vaccination     strategy consisting in the topical administration of imiquimod at the injection site before     vaccination vs. a standard intramuscular vaccine injection in SOT recipients and HIV-infected     individuals. The investigators planned to enroll 70 outpatients patients (50% solid-organ     transplant recipients and 50% HIV-infected patients) regularly followed at the     Transplantation center and the Infectious disease outpatients' clinics of the Lausanne     University Hospital. Study participants will be randomized in a 1:1:1 ratio to receive the     standard intramuscular vaccine (control group) or a topical application of an imiquimod     containing cream followed by intramuscular (imiquimod-IM) or intradermal (imiquimod-ID)     vaccine injection. After vaccination participants will be followed for a period of 180 days.     Blood samples will be drawn at baseline and at day 21 and 180 for assessment of     immunogenicity. Safety outcomes will be assessed immediately after vaccine administration,     and at day 7 (phone call), 21 and 180.   "
24820|NCT02960802|"     The cardiovascular morbidity and mortality is significantly higher in chronic kidney disease     (CKD) patients, especially in dialysis patients, than in normal population. The increased     risk of cardiovascular diseases is multifactorial.Endothelial dysfunction is one of the     explanations for the poor outcome of kidney patients. The kidney transplantation seems to     halt the progression of the cardiovascular morbidity.      Coronary flow reserve (CFR), the capacity of coronary vessels to dilate in response to     vasoactive agent, is a marker of the endothelial dysfunction. It is reduced in renal     impairment as well as in many preatherosclerotic states and coronary heart disease. The     method of choice to evaluate CRF is positron emission tomography (PET). In kidney transplant     patients CFR seems to be worse than in healthy controls but better than in dialysis patients.     However, the evidence is scarce.      Renal flow reserve (RFR) is smaller than that of heart. RFR probably reflects endothelial     function in the same way as CFR does. Declining RFR could perhaps be used to anticipate     worsening kidney function especially in kidney transplant patients and be in favour for     transplant biopsy.There are no studies of RFR in renal allograft patients.      The objectives of this study are to examine the effect of kidney transplantation on coronary     flow reserve (CFR), the change of renal flow reserve (RFR) in kidney transplant patients     during the first year after transplantation and assess the correlation between the change of     renal blood flow / RFR and kidney biopsy findings in kidney transplant patients.      The first hypothesis of this study is that coronary flow reserve of transplant patients is     better than that of dialysis patients but worse than that of healthy controls. The second     hypothesis is that renal transplant perfusion reserve is better at one year than at three     months after transplantation. The third hypothesis is that pathologic kidney biopsy findings     correlate negatively with renal perfusion reserve.   "
24821|NCT02960789|"     A pediatric study in collaboration with Boston Children's Hospital to review the performance     of two novel hydration status measurement devices against standard clinical assessment     methods, through repeated measurement of hydration status of dehydrated children admitted to     the emergency department receiving rehydration therapy, followed by an at-home follow-up     measurement once symptoms have resolved.   "
24822|NCT02960776|"     The overall goal of this project is to look at the effects of long-term, sustained sleep     restriction (SR) in adults, and assess the effects on mood and cognitive and physical     performance.   "
24823|NCT02960763|"     The purpose of this research study is to assess which antidepressants work the best in older     adults who have treatment-resistant depression.   "
24824|NCT02960750|"     This study assesses the short and mid-term impacts of a workplace web-based intervention     (Walk@WorkSpain, W@WS) on self-reported occupational sitting time, step counts,     activity-related energy expenditure, physical risk factors for chronic disease and     efficiency-related outcomes in Spanish office employees. Half of participants had access to     the W@WS website program while the other half was asked to maintain habitual behaviour.   "
24825|NCT02960737|"     The purpose of this study is to investigate the effect of a specific rehabilitation program     with oral screen used in stroke patients with persistent oral-and pharyngeal dysphagia.   "
24826|NCT02960724|"     uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer   "
24828|NCT02960698|"     Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics.     Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality     and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source     of these troubles. Its anatomical substrates is based on connections between frontal and     striatal areas.      Initially, a battery of behavioral tests measuring different types of impulsivity (motor,     cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40     patients treated and 40 untreated) and 40 healthy volunteers.      Then, investigators will study the fronto-striatal connections in the TS group of 80 patients     (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging     techniques (3T MRI). The techniques used will be functional connectivity study of resting     state MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion     tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging     data to highlight the functional anatomical substrates of impulsivity in patients with TS.      Finally, investigators will look specifically using functional MRI activation, the anatomical     and functional substrates of the three types of impulsivity (motor, cognitive and     decision-making).      Through this study, investigators hope to elucidate the anatomical and functional bases of     cognitive impulsivity in patients with TS and thus lay the basis for more targeted     treatments.   "
24853|NCT02960373|"     Dried fruits show promising potential for the management of blood glucose. Previous trials     have reported beneficial effects of raisins on post-prandial glucose and insulin responses in     healthy individuals when compared with white bread. However, to date there is limited data     evaluating the potential beneficial effects of other dried fruits (i.e. sultanas, dates and     apricots). It is also unclear whether dried fruits can be used to lower the postprandial     glycemic responses to high-GI carbohydrate foods by either displacing available carbohydrate     (displacement effect) or providing 'catalytic' doses of fructose ('catalytic' fructose     effect). To address these questions, the investigators propose to assess the GI of 4 common     types of dried fruit (raisins, sultanas, dates, apricots) (GI effect) and their ability to     decrease the postprandial glycemic response to white bread by either partially displacing     available carbohydrate (displacement effect) or by providing a 'catalytic' dose of fructose     ('catalytic' fructose effect).   "
24829|NCT02960685|"     Background: Given that an experienced physician is not always available 24 hours a day,     immediately and always available echocardiography is usually impossible in the emergency     department (ED) and intensive care unit (ICU). To compensate this limitation, the     investigators have investigated that offsite expert guided, inexperienced     practitioner-performed ultrasonography could be effectively performed. In this study, the     investigators aimed to investigate whether the offsite expert can effectively evaluate the     visually estimated ejection fraction (EF) while watching and guiding the echocardiographic     procedure of onsite novice examiner using the social network video calling chat.      Methods: sixty patients presenting to the ICU and requiring echocardiography will be     included. Sixty novice practitioners without any previous experience of echocardiography will     participate. Prior to their procedure, the onsite expert complete the echocardiography in     advance and determine the EF using the modified Simpson's method (MSM, Reference value).     Then, the novice physicians perform the echocardiography again with the offsite expert's     guidance via video call. They obtain parasternal long and short axis view and EF is visually     estimated to the nearest 5% (ex. 40%, 45% and etc) by the offsite expert while watching the     ultrasound video on the smartphone display. The subjects requiring immediate management due     to severe symptoms were excluded in this study. Interobserver variability between the     calculated by onsite expert and visually estimated by offsite expert was assessed. The     agreement of the visual estimated EF obtained by onsite expert and offsite expert via     smartphone was evaluated by linear regression and Bland-Altman plots.   "
24830|NCT02960672|"     Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly     variable clinical process.thence it is significant for the patient to search a convenient and     accurate prediction method. The objective of this study was to determine whether peripheral     blood biomarkers can predict disease .   "
24831|NCT02960659|"     Background:      The pill metformin treats diabetes. But it does not work for all youth, especially     African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers     want to understand how these drugs work and if they decrease excess sugar made by the liver     in youth with type 2 diabetes.      Objective:      To test if using liraglutide and metformin are better than just metformin for decreasing     excess sugar produced by the liver in African-American youth with type 2 diabetes.      Eligibility:      African-Americans ages 12-21 with type 2 diabetes      Design:      Visit 1: Participants will be screened with medical history, physical exam, and blood and     urine tests.      Participants will stop taking diabetes medicines for 1 week. They will learn how to check     blood sugars at home twice a day.      Visit 2: Overnight at the clinic. Participants will have:      Vital signs taken.      Pregnancy test.      A thin plastic tube (IV catheter) be inserted in each forearm by needle.      Blood drawn several times after drinking a sweet drink.      X-ray of total body fat.      Urine and stool collected.      Breath tests while wearing a clear hood for up to 45 minutes.      For several hours, participants can have only water. At 4 a.m. they will get sugar and fat     with nonradioactive isotopes in one IV. Blood will be collected. Every 30 minutes from 9 a.m.     to 2 p.m., they will drink small amounts of a shake and have blood drawn.      Participants will be randomly assigned to take either both study drugs daily or just     metformin daily.      Visits 3 4: Participants will bring their blood sugar records and have blood tests.      Visit 5, after 3 months: Repeat of visit 2.   "
24832|NCT02960646|"     The goal of this clinical research study is to learn if giving a modified stem cell     transplant is less likely to cause graft-versus-host disease (GVHD) to patients with certain     types of blood disorders or blood cancers make patients less likely to develop GVHD. You will     also receive melphalan and fludarabine as part of your regular chemotherapy and total body     irradiation (TBI) regimen.      Before you receive the stem cell transplant, it will be modified to remove certain types of     T cells that cause GVHD.      GVHD occurs when transplanted immune tissue, such as T cells and stem cells, attacks the     tissues of the recipient's body.   "
24833|NCT02960633|"     Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or     without collar design. Randomized study design focusing on radiolucent lines on standard     x-ray.   "
24854|NCT02960347|"     The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing     epileptiform activity in a 30-month-old child suffering from early onset epileptic     encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks     including pre- and post-intervention video-electroencephalography (EEG) monitoring.   "
24873|NCT02960100|"     This randomized pilot trial studies how well a mobile health (mHealth) intervention works in     increasing human papillomavirus (HPV) vaccination among college students at the Ohio State     University. mHealth educational intervention may communicate information about HPV     vaccination and increase HPV vaccine uptake in college students.   "
24842|NCT02960516|"     It is estimated that up to 5% of all admissions to level one trauma centers have a peripheral     nerve injury. These peripheral nerve injuries may have devastating impacts on quality of life     and require months or years to regain function. Neurotmesis, or peripheral nerve transection,     is a common injury, with singly cut nerve lacerations accounting for over 60% of the     peripheral nerve surgical interventions in civilian studies. For recovery to occur in these     patients, axons must grow from the site of repair to the target tissues, a length of up to a     meter in humans. By that time, revisional surgery may not be a viable option due to the onset     of irreversible muscle atrophy - a transected nerve is estimated to induce a loss of     achievable function of approximately 1% for every 6 days of delay. The scenario is even worse     for more proximal nerve injuries, such as those that occur in the brachial plexus.      The investigators aim is to longitudinally assess diffusion tensor tractography (DTI) in     order to optimize, validate, and translate the ability of DTI to monitor and, more     importantly, predict nerve regrowth following trauma and surgical repair. The overall     objective of this study is to evaluate the ability of (DTI) to monitor and, more importantly,     predict nerve regrowth following crush or cut with surgical repair. The investigators     hypothesize that the additional information available via DTI will improve our ability to     monitor and predict nerve regrowth following surgical repair or severe crush injury, guiding     clinical management either toward or away from surgical intervention.   "
24843|NCT02960503|"     Sickle cell anemia (SCA) is a life-threatening, monogenic disorder associated with early     death when compared to individuals without SCA. Pulmonary complications, namely acute chest     syndrome, obstructive lung disease and pulmonary hypertension, are the most common causes of     death in patients with SCA. Recent studies suggest that lung specific inflammation is a     hallmark of SCA and underlies pulmonary pathology. To date, no therapy has been shown to     improve the pulmonary complications of SCA. Macrolides have pleomorphic effects in the lung     with improvement in pulmonary function, symptoms and inflammatory markers demonstrated in     several inflammatory pulmonary conditions such as cystic fibrosis, asthma, COPD and     post-transplant bronchiolitis obliterans. Investigators hypothesize that low dose macrolide     therapy is well tolerated and can improve pulmonary function and symptoms in patients with     SCA. The objective of this project is to assess the feasibility of macrolides to attenuate or     reverse the decrease in %predicted FEV1 in adults with SCA in a single-site, randomized,     placebo-controlled feasibility trial.   "
24844|NCT02960490|"     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group     comparison study in rheumatoid arthritis participants inadequately responding to biologics.   "
24845|NCT02960477|"     BACKGROUND Shoulder pain is the third most common musculoskeletal disorder observed in     primary care consultations after low back and neck pain. In the absence of successful outcome     following a conservative intervention, shoulder surgery is the most common procedure conduct     for a multitude of surgical indications, including rotator cuff tears, instability and     stiffness. However, 22% of patients develop chronic shoulder pain (CSP) following shoulder     surgery . The consequences of chronic or persistent postsurgical pain result in high     socio-economic burden, not only in terms of suffering and reduced quality of life for the     individual, but also, with considered the subsequent costs to healthcare and social services.      Pain neuroscience education (PNE) has been shown as an effective therapeutic strategy for     increasing knowledge and understanding about neurobiology, neurophysiology and processing     pain, changing pain beliefs, improving patient's skills and encouraging to do physical and     social activities in different chronic pain conditions.      The primary aim of this study will be to evaluate whether perioperative PNE is more effective     than classical biomedical education in reducing pain and disability in patients undergoing     shoulder surgery. The secondary aim will be to analyse whether perioperative PNE is more     effective than classical biomedical education in reducing postoperative healthcare costs and     improving surgical experience in patients undergoing shoulder surgery .   "
24846|NCT02960464|"     Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a     treatment of depression in patients with Parkinson's Disease, through a randomized     placebo-controlled clinical trial.   "
24847|NCT02960451|"     The purpose of this study is to determine whether specialty care is superior to usual care in     the treatment of patients at clinical high risk for psychosis.   "
24848|NCT02960438|"     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group     comparison study in rheumatoid arthritis participants inadequately responding to     methotrexate.   "
24849|NCT02960425|"     Creatine is a nutritional supplement that is often ingested to improve exercise performance.     The advent of a new product that is applied to the skin overlying muscle offers potential     benefit, if the creatine can be targeted to specific muscles. The investigators are testing a     novel creatine cream to determine the effects on human muscular performance. The     investigators are assessing the acute application of two different doses of the creatine     cream on muscular power (determined by knee extension).   "
24850|NCT02960412|"     This study evaluates if administration of IV furosemide leads to expedited confirmation of     ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after     urogynecologic surgery.   "
24851|NCT02960399|"     Recommendations concerning the administration of Zostavax® in patients with antibody     deficiency are unclear. The investigators plan to assess the immunogenicity and safety of     Zostavax® in patients with antibody deficiency as compared with healthy volunteers.   "
24852|NCT02960386|"     The iTrackFitness study aims to test the engagement engine that was developed from activity     tracker and survey data gathered during phase I of the study. For the current phase the     engagement engine will support successful and sustained engagement with health trackers     thereby increasing physical activity.   "
24870|NCT02960139|"     The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled,     multicenter superiority clinical study comparing standard anastomosis closure technique     (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled     colorectal and ileorectal anastomosis procedures.   "
24856|NCT02960321|"     A prospective study aiming to analyse the relation between different variables and high     sensitivity troponin I (hsTnI) elevation within a group of patients undergoing a coronary     angiography with or without subsequent percutaneous coronary intervention.   "
24857|NCT02960308|"     This pilot clinical trial studies how well whole-neck computed tomography perfusion scans     work in imaging patients with head and neck tumors. Diagnostic imaging procedures, such as     whole-neck computed tomography perfusions scans, may provide more information about the blood     supply to head and neck tumors which may help doctors plan better treatment.   "
24858|NCT02960295|"     This is a feasibility study of care for women with gestational diabetes (GDM) using     electronic equipment to participate in virtual office visits.      Participants will be trained in the use of glucose meters, scales, and sphygmomanometers     which are Bluetooth connected to an app on their cellphones. Fetal well-being will be     assessed with Dopplers and kick counts. Care will be delivered by alternate in-office and     telephone visits.   "
24859|NCT02960282|"     This research trial studies the gut microbiome in fecal samples from patients with cancer     that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy.     Studying samples of feces from patients with metastatic cancer in the laboratory may help     doctors learn if the make-up of the gut microbiome has a positive or negative influence to a     patient's response to chemotherapy or immunotherapy.   "
24860|NCT02960269|"     This pilot study will evaluate the impact and overall experience of an interprofessional     chronic low back pain patient care approach for people in rural and remote areas using     Telehealth technology compared to secure laptop based videoconferencing (Vidyo).   "
24861|NCT02960256|"     Sepsis related to the development of cardiac complications. However, the investigators     understanding regarding this condition remains incomplete. Possible explanations raised     include coronary perfusion decrease, activation of the coagulation system and release of     inflammatory mediators, including endotoxins, cytokines and others.      In this study the investigators wanted to examine the impact of any infectious disease, (not     necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious     disease.   "
24862|NCT02960243|"     Deep Brain Stimulation (DBS) is the gold standard treatment for Essential Tremor (ET). ET is     a movement disorder which causes the arms, feet, fingers, head or voice to involuntarily     shake. The DBS surgical procedure involves implanting an electrode deep within the brain     which blocks damaging signals that cause the tremor. Essential Voice Tremor (EVT) is the     vocal manifestation of ET and a number of individuals have both ET and EVT, and when these     patients are implanted for their ET, their EVT symptoms are often also mitigated. This study     aims to quantify the effects of DBS on EVT by testing on these ET+EVT patients. In addition     to this, we hope to determine which hemisphere of the brain is responsible for larynx     control: left or right.   "
24863|NCT02960230|"     This is a two cohort Phase I study within the Pacific Pediatric Neuro-Oncology Consortium     (PNOC).      This study will assess the safety of repeated administration of the H3.3K27M specific vaccine     in HLA-A2+ children and young adults with H3.3K27M DIPGs and other gliomas.   "
24864|NCT02960217|"     UX007G-CL301 is a Phase 3, randomized, double-blind, placebo-controlled, crossover study to     assess the efficacy and safety of UX007 in the treatment of movement disorders associated     with Glucose Transporter Type 1 Deficiency Syndrome. The study will enroll approximately 40     subjects who experience disabling paroxysmal movement disorders.   "
24865|NCT02960204|"     This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects     with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by     the central reader assigned to this study). Upon successful screening, subjects will be     randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo     BID.   "
24866|NCT02960191|"     The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions     associated with vulnerability to suicidal behavior.   "
24867|NCT02960178|"     Falling is common among individuals with incomplete spinal cord injury (iSCI), with most     falls occurring while walking. Falls result in injuries (e.g., broken bones), hospital     readmission, and reduced participation in work and recreation. In able-bodied people, falls     can be prevented by taking one or more rapid, reactive steps. People with iSCI, however, have     difficulty taking the reactive steps needed to prevent a fall. Research in the elderly and     people with stroke has shown that repetitive training of reactive steps in a safe environment     improves this balance reaction and prevents falls. The investigators will examine the     feasibility and effectiveness of reactive step training in people with iSCI. The main     objective is to determine if reactive balance training leads to greater improvements in     balance reactions, scores on clinical scales, and fall rates compared with conventional     walking training. A three year, pilot randomized clinical trial (RCT) will be completed. By     improving balance and reducing falls, people with iSCI will experience fewer complications     (e.g., injuries), and greater recovery of function and community participation.   "
24868|NCT02960165|"     Objective: Evaluate whether a task practiced in virtual environment could provide better     performance than the same task in real environment and if performing a task in virtual     environment could enable transfer to the same task in real environment and vice versa.     Method: the investigators evaluated 65 older adults of both genders, aged 60-82 years. The     investigators applied a timing coincident task to measure the perceptual-motor ability to     perform a motor response. The participants were divided into two groups: a) started in a real     interface and b) started in a virtual interface.   "
24874|NCT02960087|"     The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy     chosen for this study as well as a commonly used alternate form of brachytherapy called low     dose rate (or seed) brachytherapy. Investigators would like to understand how these     treatments control the prostate cancer and look at their short and long term treatment     related side effects.   "
24875|NCT02960074|"     This is a Phase I trial to evaluate the safety and efficacy of fecal microbiota     transplantation (FMT) in the treatment of peanut allergy. In this research the investigators     would like to learn more about ways to treat peanut allergies. There is currently no known     cure for peanut allergy. The primary aim is to assess safety and tolerability of oral FMT in     patients with peanut allergy aged 18-40 years.   "
24876|NCT02960061|"     The investigators intend to conduct a randomized controlled study to find if combining HIPEC     (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2     resection could improve survival for patients with advanced gastric cancer, while comparing     with the traditional approach of D2 resection after neoadjuvant chemotherapy.   "
24877|NCT02960048|"     To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning     splint in patients with temporomandibular joint anterior disc displacement with reduction.   "
24878|NCT02960035|"     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy     of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection     (Yisaipu®) in the treatment of peripheral enthesitis in active axial spondyloarthritis(SpA)     patients. Mardird sonographic enthesis index (MASEI) was one of the most wide used scoring     systems for peripheral enthesitis and the only one based on OMERACT definition of     enthesopathy by EULAR. The primary purpose is to assess the MASEI to discover the value of US     in diagnosis and prognosis. The second prupose is to assess different maintaining treatment     programme in SpA patients with improvement of MASEI. The trial will include 96 patients with     stable NSAIDs therapy, and at the first stage they will receive 24-week full-dose of     Yisaipu®. Then at the second stage the patients who achieve low disease activity (LDA,     ASDAS<2.1) at 24th week will be randomizedly divided into three group: full-dose of Yisaipu®     group, half-dose of Yisaipu® group and placebo group. And the blind stage will last for 24     weeks. Patients who complete the 48-week therapy or achieve disease-flare criteria during the     blind stage would finish the study.   "
24879|NCT02960022|"     The purpose of this study is to collect long term safety data in subjects who are continuing     to derive clinical benefit from treatment with Enzalutamide from the subjects participation     in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study)     which has completed, at a minimum, the primary analysis or the study specified evaluation     period.   "
24880|NCT02960009|"     High definition tDCS will be conducted to both stroke and healthy subjects on primary motor     cortex area to explore the motor excitability changes before and after stimulation.   "
24881|NCT02959996|"     This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the     time of cesarean delivery may decrease post-operative pain scores.   "
24882|NCT02959983|"     This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a     day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with     Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to     provide control of their IBS-D symptoms.   "
24883|NCT02959970|"     This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of     ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with     acne vulgaris.   "
24884|NCT02959957|"     This study will evaluate the ecological impact on the intestinal microbiota and compare the     safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile     UTI. Half of participants will receive temocillin and the other half will receive cefotaxime.   "
24885|NCT02959944|"     To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects     with newly diagnosed moderate to severe cGVHD.   "
24886|NCT02959931|"     The investigators aim to evaluate the acute effects of potassium supplementation achieved by     ingestion of potassium rich food, on vascular health.   "
24887|NCT02959918|"     This is an open label multicenter study to evaluate the safety and tolerability of multiple     doses(3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase( SEL-037) and     SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase     (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and     hyperuricemia. Additional subjects will be treated with multiple doses( 5 monthly IV     infusions) of pegsiticase (SEL-037) alone.      Subjects will be monitored for safety endpoints through the 5th treatment cycle plus 30 days     .Pharmacokinetic samples will drawn a pre-determined time points in addition to weekly serum     uric acid levels.   "
24888|NCT02959905|"     The primary purpose of this study is to evaluate the safety of TSA-CTL in the treatment of     the advanced melanoma.      The secondary purpose of this study is to evaluate preliminarily the effect of TSA-CTL in the     treatment of the advanced melanoma.   "
24889|NCT02959892|"     The purpose of this study is to determine brain penetration of single oral doses of TAK-041     and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).   "
24890|NCT02959879|"     In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed     by adjuvant chemotherapy is currently the standard of care. However, the long-term results     are still poor, with median disease-free and overall survival of 14 months and 23 months. The     corresponding 5-year overall survival rate is 20%.      Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients with     rapidly progressive metastatic disease at time of preoperative restaging (surgery is then     avoided in these patients), and may increase the rate of free margin resection (R0) and     reduce the risk of local recurrence.      Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic     settings, the objective response was low (at around 10%), whereas combination chemotherapy     exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative FOLFIRINOX     chemotherapy has been demonstrated to be effective (in terms of response rates and     progression-free survival) and well tolerated. Interestingly, the response rate is increased     by using more than two chemotherapeutic agents in advanced pancreatic cancer, justifying the     use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.      PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to     assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX &     FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy)     for resectable PDAC.      Patients with immediately resectable PDAC (definition based on the NCCN's (American National     Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either     pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either     FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive     postoperative chemotherapy for 4 months (8 cycles).   "
24959|NCT02958982|"     RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this     study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple     ascending dose(s) of RP3128 in healthy volunteers and to evaluate the effect on late phase     asthmatic response to allergen challenge in patients with mild asthma.   "
24891|NCT02959866|"     We will evaluate the acceptability, feasibility and impact of an online tool that helps     patients identify financial benefits that they are entitled to at six clinic sites over a     three month period. We will answer the following questions: Is an online tool that addresses     income security feasible and acceptable to clinicians? Can such a tool be integrated into     regular clinic workflow? What is the patient perspective on the tool and what is the     short-term impact?   "
24892|NCT02959853|"     After the age of 40, there is a gradual decline in the production of testosterone. Among     obese men, the decline in testosterone levels is exacerbated by the suppression of the     hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase     enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in     turn exert a negative feedback on the hypothalamus and pituitary, leading to the inhibition     of production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle     stimulating hormone (FSH), and as a consequence, of testosterone by the testis resulting in     hypogonadotropic hypogonadism (HH). Though bone loss is a well recognized side effect of AI     in certain populations, such as women with breast cancer, HH obese men present high levels of     circulating estrogens that could potentially prevent them from bone loss, estradiol being the     main regulator of the male skeleton. This study is designed to determine if aromatase     inhibitors in combination with weight loss, compared to weight loss alone, will have a     positive effect on muscle strength, symptoms of hypogonadism, and body composition without     negatively impacting bone mineral density and bone quality. Results from this study will help     determine if certain groups of obese patients would benefit from therapy with aromatase     inhibitors.   "
24893|NCT02959840|"     The purpose of this study is to compare the effectiveness of acupressure point P6 stimulation     versus intravenous ondansetron plus metoclopramide versus no antiemetic prophylaxis during     elective cesarean section under regional anesthesia.   "
24894|NCT02959827|"     This study will estimate the incidence of hypothyroidism in a pediatric population of     children under age 4, based on data from the US-based Kaiser Permanente Northern California     database, which were exposed to iodinated contrast agent through having a diagnostic     procedure.   "
24895|NCT02959814|"     Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of     coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two     angiographic projections. The purpose of the FAVOR II study is to evaluate the diagnostic     accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA) with FFR as     gold standard.   "
24896|NCT02959801|"     The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy     (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the     treatment of acute proximal lower extremity deep vein thrombosis.   "
24897|NCT02959788|"     Identification of patients who are at highest risk for heart attack is an important task for     emergency medicine physicians. Currently, physicians use a variety of different scoring     systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a     measure derived from noninvasive cardiac monitoring. This data is collected from a simple,     non-invasive chest strap during a 10-minute recording session. The purpose of this proposal     is to collect heart rate variability data on patients admitted to the emergency department     with chest pain. The intent is to measure the association between heart rate variability and     the various risk stratification scoring systems for chest pain.   "
24898|NCT02959775|"     Uptake, adherence, and completion of vaccination among drug users were low, and their immune     function and immune response to hepatitis B vaccination were also suboptimal, indicating that     the current practice of hepatitis B vaccination can't protect drug users from HBV infection.      This is a randomized, open-label, blank-controlled trial, conducted among drug users with     drug rehabilitation. This study will compare the immunogenicity and safety of three     intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug     users   "
24899|NCT02959762|"     Animal studies have found that vitamin K-dependent proteins matrix Gla protein and     osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this     concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K     supplementation presents an opportunity to test the hypothesized link between the vitamin     K-dependent proteins and markers of lipid and glucose metabolism. The investigators will     conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein     and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk.     Sixty obese children will be randomly allocated to either the control group receiving placebo     or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).   "
24900|NCT02959749|"     Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic     change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in     non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the     treatment of first generation EGFR TKI, half of patients will get disease progression.For     patients progression after treated with first line EGFR TKI and second line double bullets     chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical     important for benefit patients' survival. We conducted this study was aimed to compare the     efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy     in patients with local advanced or metastatic non-squamous cell lung cancer.   "
24901|NCT02959736|"     The purpose of this project is to further develop a standardized music-based measure used in     music therapy with adults who have emerged from coma following profound brain injury, but are     not able to demonstrate responsiveness to their environment due to complex clinical needs.     Building on previous work, the project aims to strengthen the psychometric properties (e.g.     concurrent validity, responsiveness) of the measure for its use with adults with profound     brain damage.   "
24902|NCT02959723|"     The current aims to combine analysis of different inflammatory biomarkers and BMPR2     mutations, which are currently analyzed in each patient diagnosed with idiopathic or familial     PAH, to establish an earlier diagnosis and consequently better orientate the therapeutic     strategy in PAH.   "
24903|NCT02959710|"     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of     acetoacetate) levels after single dose administration of AC-1204 mixed in water, AC-1202     mixed in water and AC-1202 mixed in Ensure®.   "
24904|NCT02959697|"     Blepharoptosis (ptosis) repair is a common and generally well tolerated surgical procedure     usually performed using local anesthetic. However, a subset of patients appears to experience     intraoperative pain/discomfort during ptosis repair using an anterior approach with     subcutaneous local anesthetic. Posterior subconjuctival local anesthetic is currently used     for eyelid procedures such as chalazion incision and drainage and full-thickness eyelid     resections. The purpose of this study is to determine whether an additional subconjunctival     injection of local anesthetic, through the posterior aspect of the eyelid, reduces     intraoperative pain during anterior ptosis repair.   "
24905|NCT02959684|"     To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV     and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen for     HIV and hepatitis) amongst a population of legal migrants during their mandatory medical     check-up. This study aims for a global improvement of screening and care for migrants.   "
24906|NCT02959671|"     A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive     EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of     brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014 or     0.016 Nickel-Titanium archwires.      A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all     mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular     incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead.     Other mandibular brackets will remain in place. Tooth movement will be performed using     0.019x0.025 Stainless Steel archwires.      In both cohorts bracket door stability, the ability of the door to hold the archwire in the     bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the     bracket, and patient comfort in comparison with other brackets will be assessed.      The evaluation for each patient will last for at least until one archwire change (cohort 1)     or one appointment interval (6-8 weeks, cohort 2).      After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place     until the orthodontic treatment is completed.   "
24907|NCT02959658|"     This study aims to evaluate safety and efficacy of dimethyl fumarate treatment in patients     with primary progressive multiple sclerosis (PPMS).      Half of the patients will receive dimethyl fumarate and the other half will receive placebo.   "
24908|NCT02959645|"     To address joint position sense in cervical dystonia patients and how it affects the brain     activity.   "
24909|NCT02959632|"     The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted     Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of     hospitalized patients.   "
24910|NCT02959619|"     This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK     inhibitor in Chinese patients with ALK-positive non-small cell lung cancer   "
24911|NCT02959606|"     After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet     therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent     occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced     as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the     efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent     EVT for femoro-popliteal occlusive disease.   "
24912|NCT02959593|"     To determine the relationship between the affects of viewing commercially available content     through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy     subjects.   "
24913|NCT02959580|"     This study evaluates the clinical response rate of topical steroids in the treatment of     idiopathic granulomatous mastitis in female adults. Half of the participants will receive     topical steroid and the other half will receive local wide surgical excision.   "
24914|NCT02959567|"     Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing     on diagnostic or operative hysteroscopies.   "
24915|NCT02959554|"     This study aims to assess the survival benefit from an early switch approach from sunitinib     or pazopanib (10-12 weeks of 1st-line therapy) to nivolumab (anti-angiogenic to immunotherapy     switch).   "
24916|NCT02959541|"     This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of     Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from     patients with colon cancer   "
24917|NCT02959528|"     Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD)     often suffer from deficits in executive function, such as attentional control, inhibition,     and working memory. One of these executive functions, working memory, plays a critical role     in academic performance and classroom behavior. Working memory is essential for performing     complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have     shown that training of working memory has positive effects for ADHD and other cognitive     disorder in children. However, transfer effects across studies appear to be variable and     inconsistent. Event-related potentials can be a useful tool to gain insights into such     mechanism. Therefore, the aim of the present study is to investigate both near and far     transfer effects of N-back training in children with ADHD. In addition, the recording and     analysis of event-related potentials will be adopted while children with ADHD perform the     complex visuo-spatial and phonological working memory tasks.   "
24918|NCT02959515|"     The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and     OLV+capnothorax and CPAP.   "
24919|NCT02959502|"     The overall goals of this project are to assess the feasibility and impact of designing and     implementing an at-home intervention aimed at preventing long-term cognitive decline and     improving cognition in individuals currently at-risk for developing AD.   "
24920|NCT02959489|"     This study is intended to examine the impact of learning amyloid brain imaging results among     asymptomatic older adults, and how to safely communicate these results and educate on the     risk of developing Alzheimer's disease.   "
24921|NCT02959476|"     This study evaluates a Ropivacaine 0.2% Pre-Filled Dispenser in the treatment of     post-surgical pain in patients undergoing Cesarean delivery. Half of the patients will     receive Ropivicaine and half will receive placebo.   "
24922|NCT02959463|"     The goal of this clinical research study is to assess the safety of pembrolizumab (also     called MK-3475) after radiation therapy (with or without surgery and/or chemotherapy) in     patients with MPM.   "
24924|NCT02959437|"     This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors.     The study will be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation assessment     to evaluate the safety and tolerability of the DNA methyltransferase inhibitor azacitidine in     combination with the programmed death receptor-1 (PD-1) inhibitor pembrolizumab and the     indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat. Once the recommended doses have     been determined, subjects with previously treated NSCLC and microsatellite-stable colorectal     cancer (CRC) will be enrolled into expansion cohorts in Part 2.   "
24925|NCT02959424|"     Chronic esophageal disorders affect approximately one third part of global population, with a     deleterious impact in the quality of life of patients. Measured of health related quality of     life in chronic esophageal conditions such as gastroesophageal reflux disease and achalasia     are widely used to measure this important patient-reported outcome. The Northwestern     Esophageal Quality of Life (NEQOL) is a hybrid measure of esophageal illness, allowing for     broad use across esophageal diseases while maintain sensitivity to nuances of a specific     condition. The NEQOL is a reliable and valid hybrid measure of disease specific health     related quality of life across several chronic esophageal conditions. The Ecuadorian     Institute of Digestive Diseases aims to translate and validate this survey into Spanish for     its use in a Hispanic population. This cross-sectional study aims to translate, apply and     validate the NEQOL in the patients attending in the esophageal division of the institute.   "
24926|NCT02959411|"     This study will clarify the clinical usefulness of Tolvaptan therapy in patients with     complicated acute decompensated heart failure and hyponatremia (low blood sodium).   "
24927|NCT02959398|"     Tomosynthesis is an innovative technique developed in digital mammography for obtaining a     sectional image of the breast. Mammography has the main disadvantage of being an imaging     projection that creates overlays, which eliminates tomosynthesis.      The objective of this study is to evaluate if the BI-RADS classification obtained by     tomosynthesis with synthetic mammography is superior to that obtained by conventional     mammography in terms of specificity while not inferior in terms of sensitivity.   "
24928|NCT02959385|"     Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care     for patients with resectable locally advanced oesophageal cancer. Many studies suggest that     definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus     surgery for esophageal cancers who respond to chemoradiation. Herein, a single center     prospective randomized phase II clinical trial will be carried out to compare efficacy and     safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical     resection in patients who achieved clinical complete response(CCR) after neoadjuvant     radiochemotherapy for stage II-III esophageal Cancer.   "
24929|NCT02959372|"     Introduction: Despite the great advances in treatment, heart failure (HF) continues to be an     important health problem because of its high prevalence, morbidity, mortality and associated     costs. Research shows at least 40% of HF in-patients are going to be readmitted in the     following year. Thus, new strategies to reduce HF decompensations are needed.      In recent studies, pulmonary congestion which is expressed in the form of B-lines detected by     lung ultrasound (LUS) has proven to be a potent prognostic predictor of hospitalization and     mortality in HF. Moreover, the use of LUS is becoming more common due to its availability     (with pocket devices with sizes approaching those of smart phones); its simplicity (rapid     learning curve and rapid examination, less than 5 minutes) and its safety (radiation free).      We hypothesize that a management guided by LUS in HF patients may improve outcomes.      Objective: The aim of our study is to evaluate if ambulatory LUS guided treatment of patients     after a hospitalization for HF, decreases the combined end-point of mortality or     re-hospitalization after a 6 months follow-up.      Study design: The design of our study is a randomized, simple blinded, clinical trial.      Eligible patients are patients older than 18 years of age who have been hospitalized for HF.     The exclusion criteria are life expectancy of less than 6 months or uninterpretable lung     ultrasound. Eligible patients are going to be randomized into either the LUS group or the     control group.      The follow-up consists of visits to the HF clinic at periods of 15 days, 1, 3 and 6 months     after the initial hospitalization. LUS is going to be performed on all patients despite their     respective group. Only in relation to the LUS group, the treating physician will have the     result of the examination and the subsequent treatment adjustment could be made in response     to those findings.      This study complies with the Declaration of Helsinki and the study protocol is being     evaluated by the Ethic Committee of our institution.   "
24930|NCT02959359|"     For early stage of HCC, surgical resection or radiofrequency ablation (RFA) is the mainstay     curative treatments. However, recurrence is still a major issue after the surgery or RFA.     Only selected patients are eligible and tolerable to IFN-based treatment after surgical     resection and the sustained virological response varied.      Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR     and being recommended by AASLD and EASL. Mixed HCV genotype infection accounts for 10% of CHC     patients in Taiwan. Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi     plus rivavirin in the treatment of genotype 2 HCV, as well as mixed genotype 1 and 2 HCV     infection. As genotype 1 and 2 are the leading HCV genotypes in Taiwan, It can simplify the     regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin, not only for     genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection. Although an     unexpected high recurrence rate in HCC patients under DAA treatment was reported once.     However, one recent study showed a low risk of HCC recurrence after DAA treatment. In this     study, the investigators plan to enroll 130 HCV-HCC patients after confirming curative     treatment for their HCC, either by surgery or RFA. For the cases fulfilling the     inclusion/exclusion criteria, a 12 weeks Harvoni plus ribavirin treatment will be provided     for all cases (single armed design). The primary objective of the study is annual     recurrence-free survival after curative resection of HCV-HCC for up to 5 years. A     hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei     Veterans General Hospital and Investigated Sites will be recruited as historical controls.   "
24952|NCT02959073|"     In the last decades the prevalence of allergies has reached epidemic proportions. 10 to 15%     of the population suffers from cat allergy. Investigators perform this study in order to     further investigate symptom records and their evaluation in cat allergic patients.      Investigators primarily aim to better standardize the symptom recording of cat allergic     persons under real-life conditions and to evaluate the effect of hypoallergenic cats on     symptom strength.   "
24953|NCT02959060|"     This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of     BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)   "
24957|NCT02959008|"     Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand     of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the     context of changes in cerebral perfusion pressure. In this study, investigators use     Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.   "
24931|NCT02959346|"     Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in     recent years. Patients who received thoracoscopic surgery recovered much quickly and returned     to their daily life sooner because of small operation wound and less invasion. However,     operative pain was still an important factor, which might contribute to several     post-operative complications.      In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory     drugs and opioid agents, or patient-controlled analgesia for post operative pain control.     However, some side effects were observed occasionally.      The role of acupuncture in post-operative pain control was frequently discussed in recent     research. The main mechanisms of acupuncture in pain control were (1) to stimulate the     release of endogenous opioid and (2) to block TRPV1 receptor.      The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the     first clinical trial investigated the role of acupuncture in post-operative pain control for     traditional thoracotomy patients. However, there was no further research about the role of     acupuncture applied to minimal invasive thoracoscopic surgery.      Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture     in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order     to deliver a safe and effective way in pain control, and to save medical cost and promote     quality of patient care.   "
24932|NCT02959333|"     Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another     part of the body, may develop when there are penetrating wounds of the thorax and after lung     surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of     mortality and teratogenicity.      The investigators will conduct endoscopic injection of human amniotic epithelial cells to     fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the     application of human amniotic epithelial cells in the treatment of bronchial fistula.   "
24933|NCT02959320|"     Displaced femoral neck fractures are one group of hip fracture patients that are commonly     treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective     hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in     helping patients to quickly obtain high postoperative function. This approach has also been     shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies.     However, the only studies that directly compare two approaches for hip arthroplasty for     femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach     (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA.     The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our     institution, so we are setting out to determine the differences between them.   "
24934|NCT02959307|"     Transcranial Light Therapy involves non-invasive and invisible beams of light that increase     energy metabolism in the brain. Transcranial light therapy has been found to promote brain     metabolism which may help people with depression. The research team proposes a novel approach     to treating depression by using transcranial light therapy.   "
24935|NCT02959294|"     Concussion is the most common type of brain injury throughout life. Study is seeking     improvement of long-term residua following adolescent and adult post-traumatic injuries often     associated with contact sports and accidental causes. Typically defined as reversible head     injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain     (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of     AD-cSVF parenteral delivery to encourage repair of damage and decreased function following     concussion, particularly in contact, repetitive sports injuries. Range of damage is measured     in Grade I-III according to graduated severity. Unfortunately, less information is available     about repetitive concussions and the long-term health issues.   "
24936|NCT02959281|"     The purpose of this study is to investigate whether hemodynamic data obtained by a     noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome type     I (CRS1) improve clinical outcomes. We hypothesize that hemodynamic data provided to the     caring physician will improve management of CRS1 patients.   "
24937|NCT02959268|"     This is a Prospective open-label, comparative pivotal study with comparison of     self-assessments with blinded investigator assessments. Pregnant women attending the labor     and delivery unit of the hospital or emergency clinic and reporting unidentified wetness     (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be     enrolled in this study. After informed consent is obtained, each subject will be given a     single AL-SENSE to use up to 12 hours or until the perception of wetness.      Product Usage      After usage, the subject will read and record any occurrence of color change of the AL-SENSE     10 minutes after the liner removal and to mark if it changes color to blue or to green or not     on the designated form. The subjects will fill out the questionnaire regarding the product     usage experience and the liner color reading with no help from the investigator, to validate     IFU reading comprehension. A blinded clinician will perform a standard clinical diagnosis     (clinical assessment). The standard clinical diagnostic methods will include the following     tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test     and/or positive results in both the pH test and the Ferning test will be defined as a     positive clinical test result.   "
24954|NCT02959047|"     Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to     atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify     atherosclerotic plaque in the superficial femoral artery (SFA) in patients with PAD. Such     techniques have demonstrated plaque regression with statin therapy over 1 year. Alirocumab is     a PCSK9 inhibitor that effectively reduces LDL cholesterol up to 70% in patients on statins     or intolerant to statins. The investigators hypothesize that effective low density     lipoprotein (LDL) lowering with Alirocumab 150m subcutaneously (SQ) every 2 weeks will     regress atherosclerotic plaque in the SFA in patients with PAD over one year compared to     placebo. 54 patients with mild-moderate PAD (ankle brachial index or ABI 0.4-0.9) will be     randomized to alirocumab 150 mg SQ every 2 weeks or matching placebo at the University of     Virginia (UVA) (n=34) and Northwestern (n=20). The primary endpoint is change in     atherosclerotic plaque volume in the superficial femoral artery over the 1 year treatment     period. Secondary endpoints include changes in peak calf muscle perfusion after thigh cuff     occlusion/hyperemia, 6-minute walk distance, and blood biomarkers (LDL cholesterol,     fibrinogen, high sensitivity c-reactive protein (hs-CRP), and lipoprotein(a).   "
24938|NCT02959255|"     Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal     disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated     lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the     International Agency for Research on Cancer. Since then, many consensus conferences and     clinical guidelines worldwide have been established for the treatment of H. pylori infection.      Despite H. pylori infecting an estimated 50% of the global population,there is no universally     effective regimen in everyday clinical practice. The current European Helicobacter Study     Group Guidelines for the first line empirical treatment of the H. pylori infection propose a     variety of treatment strategies, as optimal treatment of H. pylori infection requires careful     attention to local antibiotic resistance and eradication patterns. Most recently, the Toronto     Consensus for the Treatment of Helicobacter pylori Infection in Adults strongly recommended     that all H. pylori eradication regimens now be given for 14 days. Recommended first-line     strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] +     amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple     therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]).The aforementioned statement by     an international working group of specialists chosen by the Canadian Association of     Gastroenterology is of the outmost importance, especially in countries with increased     antibiotic resistance, like Greece, with resistance rates >20% to clarithromycin and >40% to     metronidazole.   "
24939|NCT02959242|"     To assure the quality of follow-up and treatment, data of glaucoma patients are stored and     evaluated after anonymisation.   "
24940|NCT02959229|"     The present study was designed to evaluate the effectiveness of oral lactoferrin in     prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours)     Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration     on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of     prematurity and necrotizing enterocolitis.   "
24941|NCT02959216|"     This study evaluates the efficacy of aerobic exercise in the acute phase of recovery for     pediatric patients with a concussion. Half of participants will complete sub-symptom     threshold aerobic exercise and half of participants will complete a placebo stretching     protocol.   "
24942|NCT02959203|"     Background:      Insertion of a central venous catheter (CVC) could lead to a variety of complications.      To detect those complications, Chest X-ray (CXR) is still the reference standard. However,     there are major limitations in performing CXR's in the critical care setting.      Aim/objectives:      The objective of this study is to compare the use of bedside ultrasound (US) to conventional     CXR in visualization of accuracy and safety of the CVC placement. The aim is to eventually     replace X-ray with bedside ultrasound as gold standard for the confirmation of CVC-placement     in critically ill patients, thereby reducing radiation exposure and unnecessary delay before     CVC use.      Methods:      The bedside US will be performed by the student or attending physician, who is blinded for     CXR findings. After US examination, the attending physician (or student) will fill in a     structured form, based on an established protocol. CXR will be performed before or after US     examination and assessed by a radiologist. The radiologist will be blinded for the findings     of the bedside ultrasound to prevent any biases. Final diagnosis will be determined after     examination of the complete medical chart.   "
24943|NCT02959190|"     The main purpose of this study is to evaluate the safety and effectiveness of the study drug     known as Galcanezumab in Japanese participants with migraine.   "
24944|NCT02959177|"     The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in     Japanese participants with episodic migraine.   "
24945|NCT02959164|"     The purpose of this Phase 1b study is to assess the safety and maximum tolerated dose (MTD)     of Decitabine in combination with Gemcitabine among previously treated patients diagnosed     with advanced pancreatic adenocarcinoma or sarcoma (soft tissue and bone).   "
24946|NCT02959151|"     The purpose of this study is to collect the date on the safety and potential effectiveness of     CART cells combined with interventional therapy in patients with advanced liver malignancy.   "
24947|NCT02959138|"     The primary objective of this study is to evaluate the pharmacokinetics (PK) of GS-9876 in     participants with impaired renal function relative to matched healthy controls. Participants     in this study will be enrolled using an adaptive design that includes up to 3 enrolled     cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled in     adaptive Cohorts 2 and/or 3.   "
24948|NCT02959125|"     This study evaluates the intervention of Nut Fish based food, micro nutrients supplementation     and pregnancy class to improve maternal and birth outcome. This is cluster randomized trial     with two arms. The intervention group will receive Nut Fish based supplementation, multiple     micro nutrients, and pregnancy class. The control group will receive government food     supplementation, iron folic acid supplementation, and pregnancy class.   "
24949|NCT02959112|"     Endoscopic retrograde cholangiopancreatography (ERCP) complications occur in 5 to 10% of     cases, post ERCP pancreatitis is the most common, it is a complication with significant     morbidity, occasional mortality and high costs. In the prevention of post-ERCP pancreatitis     have been used various treatments, NSAIDs and pancreatic stent are the most useful, however,     despite its use, post ERCP pancreatitis continues to affect 10 to 15% of patients with high     risk. Epinephrine sprayed on the papilla may decrease the edema and prevent the development     of this complication.   "
24950|NCT02959099|"     The ICONIC study is a retrospective, international, multicenter, nested case-control study     based on propensity scoring methods to match patients with (Cases) and without (Controls) an     acute coronary syndrome (ACS). Our objective is to identify atherosclerotic plaque     characteristics (APCs) that may be implicated in future ACS and compare gender-specific     disparities, if any, in coronary plaques among women and men who subsequently experience a     future ACS. The primary outcome is an ACS comprised of ST elevation myocardial infarction     (STEMI), non-ST elevation MI (NSTEMI), or unstable angina, and the secondary outcome of MI     includes STEMI and NSTEMI only.   "
25058|NCT02957695|"     In this randomized double-blind controlled study we would like to test the benefit of     neurofeedback for the recovery of patients with frontal brain injury during an early stage of     neurorehabilitation.   "
24960|NCT02958969|"     Patients living with multiple myeloma (MM) have an increased risk of venous thromboembolism     (VTE) due to the disease itself and the use of targeted therapies, including immunomodulatory     drugs (IMiDs). Prevention of VTE has become a major management challenge during MM treatment.     There is a paucity of data with respect to the non-vitamin K oral anticoagulants (NOACs) in     the cancer population. However, the NOACs offer comparable efficacy but improved safety     compared with warfarin. Apixaban has shown excellent safety and efficacy for treatment and     prevention of recurrent VTE (1,2). The safety and efficacy of apixaban for primary prevention     of VTE in MM patients has not been established.      Aim #1: To quantify the 6-month rate of major and clinically relevant non-major bleeding in     MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary     prevention of VTE.      Hypothesis #1: The 6-month rate of major and clinically relevant non-major bleeding in MM     patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary     prevention of VTE will be ≤3% (2). Although the MM population, in general, has a higher     medical acuity than that of the previous large randomized controlled trials of apixaban, we     will be selecting a stable population of MM patients who are appropriate for immunomodulatory     therapy.      Aim #2: To quantify 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are     prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE.      Hypothesis #2: The 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are     prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be <7% (3).     Although additional therapies for MM such as dexamethasone and erythropoietin-stimulating     agents may further increase the risk of VTE, the rate of incident VTE should be reduced to     <7% with apixaban.   "
24961|NCT02958956|"     The purpose of this study was to evaluate whether treatment with pioglitazone is associated     with risk of incident cancer at the 10 most common sites in a cohort of participants with     recognized diabetes.   "
24962|NCT02958943|"     Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely     available risk stratification tools, five options for oral anticoagulation, and     evidence-based practice guidelines, anticoagulation for stroke prevention in AF is     consistently under-prescribed. Data from our center (Brigham and Women's Hospital [BWH]) (1)     demonstrate that fewer than 50% of outpatients with AF at high-risk for stroke according to     2012 Focused Update of the European Society of Cardiology Guidelines for the Management of AF     (2) receive anticoagulation.      Aim #1: To determine the impact of electronic alert-based computerized decision support (CDS)     on prescription of anticoagulation in high-risk AF patients in the outpatient setting who are     not being prescribed anticoagulation for stroke prevention.      Hypothesis #1: Electronic alert-based CDS will increase prescription of anticoagulation by     80% in high-risk AF patients in the outpatient setting who are not being prescribed     anticoagulation for stroke prevention.      Aim #2: To determine the impact of electronic alert-based computerized decision support (CDS)     on the frequency of stroke and systemic embolic events in high-risk AF patients in the     outpatient setting who are not being prescribed anticoagulation for stroke prevention.      Hypothesis #2: Electronic alert-based CDS will reduce the frequency of stroke and systemic     embolism in high-risk AF patients in the outpatient setting who are not being prescribed     anticoagulation for stroke prevention. Data acquired through this study regarding the     frequency of stroke and systemic embolism will be used to calculate sample size requirements     for a future clinical end-point driven randomized controlled trial of electronic alerts to     prevent stroke in high-risk AF patients.   "
24963|NCT02958930|"     The purpose of this study is to determine the safety and initial efficacy of Transcranial     Electromagnetic Treatment (TEMT) in patients with mild/moderate Alzheimer's Disease.     Throughout a 2-month treatment period, patients will be evaluated for cognitive performance,     brain energy utilization, functional brain imaging, and blood/cerebrospinal fluid (CSF)     markers for Alzheimer's Disease. Since all patients will receive TEMT, each patient's     baseline measurements will serve as their own control for any treatment effects.   "
24964|NCT02958917|"     Patients are being offered participation in this pirfenidone trial because They have been     diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung     disease (ILD). This is a disease where scarring of lung tissue occurs as the result of     inhaling substances called antigens. These antigens can be substances such as molds,     chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen into     the bloodstream to reach other organs.      Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This     drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic     Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your     condition. The use of pirfenidone has not been approved for the treatment of FHP. It is     considered experimental treatment in this study.   "
24965|NCT02958904|"     Aims: assess the relationship between sexual function and depressive symptoms in individuals     with spinal cord injury.   "
24966|NCT02958891|"     An epidemiological survey for prevalence description of dental morbidity (caries, gingivitis,     dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits. Morbidity     measures were collected from 700 recruits at their first day of military service in order to     evaluate extent and burden of dental diseases among recruits. The data will enable the     military dental services commanders to plan and implement dental services according to the     dental needs.   "
24967|NCT02958878|"     Double blinded, randomized controlled prospective study looking at 2 preoperative doses of     Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention. A     previous study was conducted called Effectiveness of tamsulosin inprevention of     postoperative urinary retention: a randomized double-blind-placebo controlled study This     study involved a tertiary care center involving mostly urological surgical procedures. We     look to specifically look at inguinal hernia surgeries in males. The aim of this study is to     compare the prophylactic effect of tamsulosin with placebo on postoperative urinary     retention. The drug is FDA approved for benign prostatic hypertrophy and urinary retention.     It is on formulary at Genesys. Currently there is no standard procedure of prophylactic     tamsulosin for urinary retention. Most often post operative patients are given tamsulosin to     augment smooth muscle relaxation and spontaneous voiding if the patient is having urinary     retention post operatively. We often straight catheterize patients once and start tamsulosin     with the goal of avoiding urinary retention and future straight catheterizations or placement     of foley catheters   "
24968|NCT02958865|"     The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective     in treatment of moderate to severe ulcerative colitis.   "
24969|NCT02958852|"     A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to     Endocrine Treatment with Focus on Mechanisms of Resistance to Endocrine Treatment     (fulvestrant/aromatase inhibitors) in Patients With Advanced Breast Cancer.   "
25002|NCT02958423|"     The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current     stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the     spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients     suffering of endometriosis-related chronic pelvic pain (CPP)   "
24972|NCT02958813|"     This study has three specific aims:        1. To conduct a 2-arm randomized controlled trial comparing IMARA to a family-based health          program (FUELTM). The investigators will:           a. Randomly assign 300 14-18 year-old AA or black girls and their primary female          caregivers to IMARA (N=150) or FUELTM (N=150). Women and girls will be recruited four          ways: 1) from mental health clinics using clinic liaisons, 2) flyers will be posted in          clinic recruitment sites and other agencies instructing interested families to call our          recruiter, 3) IMARA participants will hand flyers to interested women and girls they          know, and 4) COIP field station staff will pass out flyers and recruit interested women          and girls at the field stations and in the community. Investigators will examine the          effects of IMARA on women and girls' sexual behavior at 6- and 12-months.        2. To evaluate the impact of IMARA on theoretical mediators posited by the Theory of Gender          and Power and the Social-Personal framework associated with AA women and girls' risky          sex. Investigators will:             1. Assess changes in women and girls' Individual Attributes (HIV/AIDS knowledge,               attitudes, and beliefs, mental health/emotion regulation, ethnic identity); Peer               and Partner Processes (partner characteristics, relationship power dynamics, peer               influences, partner communication); and Family Context (mother-daughter               relationship and communication, parental monitoring) at baseline and follow-ups.             2. Evaluate mediation and moderation of theoretical mechanisms on women and girls'               sexual behavior.        3. To assess the impact of IMARA compared to FUELTM on sexually transmitted infections          (STIs). Investigators will:             1. Test women and girls' urine for three common STIs at baseline and 12-month follow               up.             2. Explore linkages between biological outcomes and targeted mediators and moderators               of change.   "
24973|NCT02958800|"     Aggressive behaviours in long-term care (LTC) is a difficult health care issue to manage. One     method that has been over-used is the prescription of antipsychotics for the behaviours and     psychological symptoms of dementia (BPSD). This high prevalence of use is a recognized health     care problem in Ontario and around the world; increased antipsychotics use is associated with     increased falls and mortality. Existing strategies are educational in nature and are not     systematic; the goal of this study is to develop a systematic algorithm to help LTC     physicians deprescribe and taper antipsychotics safely and effectively.      The objectives of the study is to: 1) Develop a discontinuation algorithm for antipsychotics     based on single patient open-label (SPOT) trial methodology (e.g. a variation of N-of-1     trials) with standardized outcome measures for LTC physicians; 2) To pilot a clinical     pharmacist-led recruitment strategy; 3) To provide preliminary evidence to demonstrate that     this algorithm could lead to deprescribing of anti-psychotic medications in LTC.   "
24974|NCT02958787|"     Prostate cancer patients have a number of excellent treatment options to consider, and     quality of life following treatment is often a consideration in treatment choice. One     critical quality of life concern for patients diagnosed with prostate cancer is sexual     function. Previous studies point to a vascular mechanism of impotence post-radiation therapy,     as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular     structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging     and included in treatment planning for radiation treatments, hopefully preserving critical     artery function. This study will collect erectile function preservation rates at 5-years     post-vessel-sparing radiotherapy with or without aids using the patient reported using the     simplified three-question erectile function scale.   "
24975|NCT02958774|"     The primary objective of this study is to determine whether lymphedema rates are decreased in     patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as     compared to conventional radiation.   "
24976|NCT02958761|"     Primary aim of this trial was to assess efficacy three intraarticular injections of platelet     lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment     groups in terms of a number of functional scales and of number of adverse events.   "
24977|NCT02958748|"     To evaluate change of different immune cellsduring ARDS and its impact on prognosis.   "
24978|NCT02958735|"     The purpose of this study is to determine whether an acute bout of exercise may temporarily     enhance cognitive function (such as memory or attention span) by measuring behavioral     performance on cognitive tests, as well as expression of hormones in circulation associated     with brain plasticity and stress.   "
24979|NCT02958722|"     The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for     suspected uterine pathologies. Women will be randomized into two groups on the basis of     distension medium : group A CO2; group B physiological solution. Pain discomfort will be     evaluated after the examination.   "
24980|NCT02958709|"     In this open-labeled, randomized clinical trial, the Investigator will assess the safety and     pharmacokinetics (PK) of model-optimized doses of rifampicin (RIF) with or without     levofloxacin (LEVO) given to children as part of multidrug treatment for tuberculous     meningitis (TBM) versus standard treatment. The Investigators will also assess functional and     neurocognitive outcomes by treatment group, as measured by the Pediatric Modified Rankin     Score (MRS) and the Mullen Scales of Early Learning (MSEL), respectively.   "
24981|NCT02958696|"     HTL0018318 is a selective muscarinc M1 agonist. This study is a phase I, open label,     randomised, crossover, single dose, trial in healthy volunteers to compare the relative     bioavailability of HTL0018318 when given by oral aqueous solution and in capsule formulation.   "
24982|NCT02958683|"     Breathing movements, called chest wall motion, are very complex. The investigators are     studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how this     differs with different diseases in the chest. Breathing movements may help with diagnosis,     assessment of severity or assessing the impact of treatments for chest conditions. The     investigators are following people who have a chest disease, measuring their chest wall     motion and comparing it to their diagnosis and and how their treatment works.      Chest wall motion can be measured in different ways at rest and whilst exercising. Small     stickers on the chest can be used to reflect infra red light or visible squares of light can     be shone onto the chest without using stickers.   "
24983|NCT02958670|"     Cerebral accumulation of tau and beta-amyloid are major factors of Alzheimer's disease     pathology. A novel Positron Emission Tomography (PET) tracer (18-F-AV-1451) now offers the     ability to study tau protein deposition in vivo in subjects, in which information on cerebral     amyloid deposition has already been gathered. This enables to study effects of tau deposition     on neuronal integrity, their relation to effects of beta-amyloid deposition and how this     contributes to cognitive impairment or well-being in the elderly.   "
24984|NCT02958657|"     This project aims to evaluate, in recent post-acute myocardial infarction (AMI) patients on     dual antiplatelet therapy, the impact of regular exercise training on platelet aggregability     and the correlation between the level of platelet aggregability and muscle sympathetic nerve     activity (MSNA).   "
25059|NCT02957682|"     The main purpose of this study is to evaluate the effect on mental state (known as     neurocognitive function) with use of Praluent.   "
24985|NCT02958644|"     Obese patients have a high level of intestinal microflora imbalance, with serious     consequences such as loss of digestive function. Potential mediators of intestinal microbiota     are prebiotics, supplements considered safe because they are naturally contained in food and     human microbiota. Their use has been studied as new therapeutic approach for the regulation     of intestinal microbiota in various situations of disease, including severe obesity.      This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of     prebiotic supplementation (fructo-oligosaccharide - 12 g / day) on body mass index in     participants with obesity class III, with follow up of 90 days.   "
24986|NCT02958631|"     Comparison of blood pressure lowering effect between Fimasartan and Losartan in the     hypertensive patient during night and early morning time   "
24987|NCT02958618|"     Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in     treating common bile duct stones. It had the similar success rate of stone extraction, but     its incidence of complications remained uncertain. However, there is no clinical evidence and     guideline to define the optimal duration of balloon dilation so far. So we designed a     prospective randomized trial to compare the effect of three different duration of balloon     dilation during ESBD so that we can find the optimal duration of the balloon dilation.   "
24988|NCT02958605|"     Medication errors are common in children. Characteristics of errors during critical     situations in the Emergency Department are ill-defined and might be more frequent than     previously thought. However, optimal strategies to eliminate the risk of prescribing errors     remain unknown.      Many smartphone apps have been suggested over the last years with some of them designed to     calculate medication dosage for children. The impact of these apps to decrease dosage error     has never been evaluated in resuscitation setting.      The aim of the study is to evaluate whether the use of a smartphone application designed to     calculate medication doses decreases prescribing errors among residents during pediatric     simulated resuscitations.      This will be a crossover-randomized trial using high fidelity simulation among 40 residents     rotating in the pediatric emergency department.   "
24989|NCT02958592|"     To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for     staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors     before hepatic resection, using resected tissue pathology as a reference standard.   "
24990|NCT02958579|"     Metabolic syndrome (MetS) is recognized as clustering of a number of components including     hypertension, hypertriglyceridemia, low serum high-density lipoprotein cholesterol (HDL-C),     impaired glucose metabolism (IGM), and abdominal obesity. It has been tightly linked to     thrombotic vascular events including coronary heart disease (CHD). Worldwide prevalence of     MetS is on the rise. People living in Iran, a country located in the Middle-East region, have     distinct behavioral, environmental and social exposures which certainly affect the prevalence     and incidence of metabolic syndrome and its comorbidities.We hypothesized that these factors     may affect the course of metabolic syndrome and the burden that it imposes to the community.     The purposes of MetSCoM are as follows;        1. To find the incidence of T2D, microvascular complications of T2D (diabetic retinopathy,          diabetic neuropathy and diabetic kidney disease), CVD, and mortality rate of subjects          metabolic syndrome.        2. To find the association of baseline, mean value during follow up visits and visit to          visit variability in anthropometric variables and several metabolic laboratory variables          with metabolic syndrome and its complications.        3. To find the effect of behavioral variables and environmental exposures on the course of          metabolic syndrome.        4. To identify the best anthropometric, laboratory, life-style and environmental predictors          of CVD and mortality rate in subjects with metabolic syndrome.        5. To estimate the economic burden of metabolic syndrome and its related   "
24991|NCT02958566|"     The General Objective of this study is to investigate the cost and efficacy of treating     patients undergoing colorectal surgical resections with an opioid limited pain control     regimen as part of an Enhanced Recovery After Surgery (ERAS) Protocol. This group will be     compared to a traditional opioid based pain control regimen.   "
24992|NCT02958553|"     A study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in     active seniors.   "
24993|NCT02958540|"     The study is a double-blind (within dose level), placebo-controlled Phase I study to assess     the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low     dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs),     each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day     29. The two dose levels will be recruited sequentially.      Immunogenicity end-points will include assessment of humoral and cellular responses at     selected time-points.   "
24995|NCT02958514|"     This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused     by meibomian gland dysfunction and make a comparison between the traditional treatment.   "
24996|NCT02958501|"     The purpose of this study is to confirm anticipated substitution dose of the vitamin D for     sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)   "
24997|NCT02958488|"     The main objective of the study is to gather preliminary data on the effectiveness of High     Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in     newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS).      The secondary objective is to evaluate the safety of HFNC in this indication.   "
24998|NCT02958475|"     This study is being conducted to evaluate the breastfeeding support program utilizing     bilingual English-Spanish tailored text messages and online support to support exclusive and     continuous breastfeeding for new mothers--comparing texting alone, texting with an online     support group to those with usual care. The cost involved in moderating the online groups and     providing bidirectional consultation when needed will be evaluated and qualitative feedback     from a subset of mothers in both intervention groups will be evaluated to determine what was     effective, as well as suggestions for improvement of the messaging program.   "
24999|NCT02958462|"     The use of genomics and functional translational studies is to identify and diagnose patients     with precursor features of myeloid neoplasms and inherited bone marrow failure syndromes.   "
25003|NCT02958410|"     The overall purpose of this study is to explore the therapeutic effect of BCMA-targeted     chimeric antigen receptor T(CAR-T) cells in the treatment of lymphocyte derived malignancies.   "
25006|NCT02958371|"     Previous studies have suggested that consumers who can choose what to eat could find food     more pleasant, and consume more of that food, than when in absence of choice. However     cognitive mechanisms that could explain the effect of choice have not been investigated. The     study consists in a fMRI experiment intended to observe the effect of the presence of choice     on brain activity following consumption of a fruit-flavored drink, compared to the brain     activity when the same drink is consumed without choice. It is suggested that consumers will     appreciate drinks they chose better, and that the activity in gustatory and reward regions     will change accordingly to changes in declared food pleasure.   "
25007|NCT02958358|"     The investigators are doing this research study to find out how blood flow changes in the     lungs of people with pulmonary hypertension before and after treatment with ambrisentan (sold     under the brand name Letairis). The investigators hope that knowing about these differences     will help us to better understand pulmonary hypertension and find new ways to diagnose it     earlier.   "
25008|NCT02958345|"     Study Design:      Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis.      Subjects will receive either Zostavax or placebo and will be followed for four months.      Hypothesis:      The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic patients     like that seen in elderly patients.   "
25009|NCT02958332|"     Aims: To demonstrate the effect of a program based on video games as a means to improve     abilities and basic skills affected by lymphedema, and its impact on quality of life.      Design: longitudinal, pre-experimental, with pre / post-test and evaluation, assessor blinded     study.      Method: Data on shoulder pain and disability, health-related quality of life, strength and     articulate activated by the OSS (Oxford Shoulder Score), SPADI (Shoulder Pain and Disability     Index), FACT-B + 4 (Functional Assesment of Cancer Therapy Questionnaire for Breast Cancer),     respectively goniometry and dynamometry amplitude scales will be collected.      The intervention will be performed with the Wii ™ console and the Wii Balance BoardTM, during     5 individual weekly sessions of 30 minutes.   "
25010|NCT02958319|"     Patients with rheumatoid arthritis (RA) with positive antibodies against carbamylated     proteins (anti-CarP) have a more severe clinical course. The primary objective of this study     in adult subject with RA is as follows: To explore the clinical differences in activity     indexes (Disease Activity Score of 28 joints with Erythro Sedimentaion Rate (DAS28-ESR)) at     6, 12 and 18 months of follow up according the anti-CarP antibodies status.   "
25011|NCT02958306|"     The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of     unilateral cleft lip repair.   "
25012|NCT02958293|"     This is a retrospective cohort study using Electronic Privacy Identification Center (EPIC)     database to evaluate if there are any differences in perioperative morbidity for elective     surgery based on the time of the year surgery is performed.   "
25013|NCT02958280|"     The purpose of the study twofold: first, a smartphone-based physical activity application     (app), which will be called Fit&Sober, will be developed and tailored specifically for     patients with alcohol use disorders (AUDs); then, the feasibility, acceptability, and     short-term increases in physical activity with the use of the Fit&Sober app will be examined     over the course of a 12-week intervention.   "
25014|NCT02958267|"     The purpose of this study is to determine the clinical response to autologous bone marrow     aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis     with respect to pain, function, and quality of life at up to 1 year following the     intervention. Specifically, the clinical response will be compared to baseline and a control     group treated with a Gel-One® hyaluronate injection to the target knee.   "
25015|NCT02958254|"     No previous studies have compared the association between muscle thickness (MT) and muscle     cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to     investigate the validity of ultrasound in assessing the muscle thickness of hamstrings     muscle.      Study design:      A cross-sectional-validity study.      Setting:      University      Participants:      X football players of an amateur football team (X healthy volunteers and X patients with a     previous hamstring injury).   "
25016|NCT02958241|"     This study investigates the possible differences in images obtained in patients with lumbar     spondylolisthesis when positioned in an upright weight bearing position compared with     traditional supine positioning for lumbar MRI.   "
25017|NCT02958228|"     The purpose of this randomized controlled trial is to establish feasibility and provide     initial estimates of efficacy of two computerized cognitive training procedures (a form of     Positive Mental Imagery Training, PMIT, and a form of Cognitive Control Training, CCT)     delivered as adjuncts to treatment as usual (TAU) in inpatient mental health treatment     settings.   "
25018|NCT02958215|"     Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at     increased risk of symptomatic hypotension after spinal anesthesia   "
25019|NCT02958202|"     The aim of this study is to provide continuing access to BMN 044 treatment for subjects     previously treated with BMN 044. The information gained from this study is expected to     further characterize the efficacy and safety of BMN 044 over a longer treatment period.   "
25020|NCT02958189|"     The purpose of this study is to determine whether a Twitter-based intervention with a     private, online support group can significantly increase number of walking steps compared to     self-monitoring of physical activity alone or a control group in sedentary women at a women's     heart clinic.   "
25021|NCT02958176|"     Low resting heart rate variability (HRV) has been associated with sexual arousal problems and     overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads to     increases in HRV as well as improvements in symptoms associated with several psychological     disorders, some of which are comorbid with sexual arousal problems in women. Autogenic     training also facilitates increases in HRV and was recently associated with acute increases     in sexual arousal among sexually healthy women. The primary aim of the current study is to     examine the efficacy of HRV biofeedback, with and without autogenic training, for the     treatment of female sexual arousal disorder (FSAD).   "
25178|NCT02956109|"     Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic     kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics     of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel     orodispersible tablet formulation for the treatment of children, in comparison to the adult     tablet formulation.   "
25022|NCT02958163|"     This will be multicentre a phase II randomized controlled and open-label trial. It will     compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead     Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic     Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B.      This trial will also include one substudy. This substudy will confront the     immuno-histochemical results collected on tumoral biopsies to the biological and imaging     (MRI) results. Every patient participating to the trial can also participate to this     substudy.   "
25023|NCT02958150|"     This study compare the effectiveness of dexmedetomidine as a sedative drug during NIV and the     different strategies routinely used in patients with ARF of different aetiologies. Efficacy     will be assessed based on absence of intubation, short term prognosis, and occurrence of     medical complications.   "
25024|NCT02958137|"     Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT   "
25025|NCT02958124|"     The purpose of this study is to evaluate the feasibility and the security of early     mobilization of infants in pediatric intensive care.   "
25026|NCT02958111|"     This is an randomized, controlled, multicenter phase 3 clinical trial. The purpose of this     study is to evaluate the efficacy and safety of single-agent capecitabine as adjuvant     chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC).   "
25027|NCT02958098|"     The My Research Legacy Pilot Study will establish a participant registry that collects     self-reported health data and answers to online survey questions about individual daily     choices, diets, and exercise; data from wearable devices; and, (optional) data from genome     sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will     answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check     v4.0 three times over the course of 6 months, transmit data from a Fitbit Charge 2 device,     and (optional) provide a saliva sample for whole genome sequencing.   "
25028|NCT02958085|"     This trial is conducted in The United States of America. The aim of this trial is to     investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the     body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple     Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.   "
25029|NCT02958072|"     An International Multicenter study evaluation, off the effect of the fully autologous growth     factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers in patients     with diabetes.      To compare the impact of LeucoPatch as part of usual care in multidisciplinary Diabetes Foot     clinic settings, versus usual care in the same clinics on malleoli ulcers healing.   "
25030|NCT02958059|"     Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that     allows minimally invasive management of biliary and pancreatic disorders. However, the     incidence of infectious complication of ERCP is considerable. Transient blood stream     infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection     accounts for about 10% of the major complications associated with mortality.      Although prophylactic use of antibiotics is generally not recommend in all cases, debates     about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is     recommend in case of ERCP that incomplete biliary drainage is expected.      In this study, researchers will use prophylactic antibiotics in patients with biliary     obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based     on the data of our institution, and administered to patients before ERCP procedure.   "
25031|NCT02958046|"     The purpose of this study is to investigate the efficacy of lansoprazole combination with     domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance     kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).   "
25032|NCT02958033|"     In this study,the eligible breast cancer patients will be randomized divided into two groups.     the study group receive the accelerated hypo-fractioned whole breast irradiation with a     concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group     receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor     bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external     beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the     accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy.     The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis     and cardiac disease, cosmetic outcome ,local control and survival outcome.   "
25033|NCT02958020|"     This is a multicenter cohort study on osteoporosis in six cities of China which locate in the     east, south, north, west, middle of China respectively. At least 3000 middle-aged and elderly     permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every city were     enrolled. Residents with severe mental diseases, physical diseases or acute infectious     diseases who could not cooperate with the survey as well as lactating or pregnant women were     excluded. All the enrolled residents who signed informed consent will finish questionnaire     including demographic characteristics, history of smoking, alcohol drinking, falls and     fracture, family, chronic diseases and medicine,diary and physical practice. Osteoporosis     risk, health status (EQ-5D) and constitution of traditional Chinese medicine (TCM) will be     evaluated. Fasting blood tests, bone mineral density and physical examinations (height,     weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and     pulse) will be performed at enrollment and every two years after enrollment. DNA of blood     cells will be preserved.   "
25062|NCT02957643|"     The purpose of the study is to investigate the effectiveness of iron in the treatment of iron     deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the     hemoglobin, hematocrit and iron in serum and assess the course of treatment.   "
25049|NCT02957812|"     The purpose of this study is to explore the long-term effects that orthotics imposes on the     structure and function of the foot. The objectives of the study are to determine if the use     of custom-made foot orthotics (CFO) cause: (a) changes to the structure of the plantar     intrinsic muscles, (b) changes in the rate of muscle activity and timing in the plantar     intrinsic muscles and (c) creates any changes in balance control during gait termination. The     aim of the study is to enhance the appropriate dispensing of orthotics, and whether     additional measures, such as rehabilitation exercises are necessary to increase their overall     effectiveness in the clinical setting.   "
25034|NCT02958007|"     Older adults with psychotic disorders experience a dual set of challenges: those related to     serious mental illness, and those related to aging. They have medical, cognitive,     psychological and social difficulties; as a result they have an almost four times greater     likelihood of early institutionalization in nursing homes. These challenges make it difficult     for this group to engage in health behaviors, such as exercise. This is unfortunate, since     participation in health-promoting activities is essential for maintaining functional     independence with age. This study aims to develop and pilot test a peer coaching intervention     for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans     in recovery from mental illness, will provide intensive coaching to older Veterans with     psychotic disorders to promote their participation in exercise and physical activity. Results     from this study will inform us as to whether this intervention is acceptable to Veterans,     feasible to implement, and effective in increasing exercise, physical activity, and physical     fitness/function.   "
25035|NCT02957994|"     To evaluate various markers of renal function and bone density after the switch to Tenofovir     alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with     Tenofovir disoproxil fumarate (TDF) .   "
25036|NCT02957981|"     The primary goal of this research is to develop and test a web-based genetic     education/counseling intervention. This intervention is designed to educate men from     hereditary cancer families about the personal relevance of genetic testing in order to help     them make decisions about whether to pursue genetic testing. The investigators will test this     intervention against standard care for men from hereditary cancer families. The web-based     educational intervention includes all of the information typically covered during genetic     counseling. As a result, after completing the education intervention participants can proceed     directly to genetic testing if they choose. The investigators will conduct a survey prior to     randomization and then follow-up surveys at 1-month and 6-months post-randomization. The     primary outcome will be uptake of genetic testing. Secondary outcomes will be completion of     genetic counseling and decision satisfaction.   "
25038|NCT02957955|"     This study evaluates the addition of high-intensity interval training to the standard     pre-heart transplantation clinical care. Participants will be randomised into 2 arms: one arm     will receive high-intensity interval training, and the other arm will be encouraged to remain     physically active, although they do not participate in a regular structured exercise training     program.   "
25040|NCT02957929|"     This is a Phase l double-blind, placebo-controlled, randomized study to investigate the     safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of     APX001 administered intravenously and orally, followed by an evaluation of the safety,     tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of     APX001 administered orally.   "
25041|NCT02957916|"     In order to better understand early onset obesity and to identify patients in interested in     future research studies, including clinical trials, we aim to develop a registry for patients     with early onset obesity.   "
25042|NCT02957903|"     The purpose of this study is to investigate and describe the anatomical distribution of the     sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to     the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine     whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be     conducted in healthy volunteers in a blinded, randomized paired study.   "
25043|NCT02957890|"     This study evaluates the immunogenicity of adding inactivated influenza vaccine with southern     hemisphere (SH) formulation to standard once-annual influenza vaccination with northern     hemisphere (NH) formulation in older adults in Hong Kong over 5 years. Half of participants     will receive twice-annual influenza vaccination with NH and SH formulation, while the other     half will receive once-annual influenza vaccination with NH formulation and a placebo.   "
25044|NCT02957877|"     There is a lack of data in the literature about the use of low-molecular weight heparin     (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to evaluate     the efficacy and safety of LMWH, administered by infusion method, as compared to     unfractionated heparin as anticoagulation for NHHD treatment.   "
25060|NCT02957669|"     The purpose of the study is to determine the impact of the offer to participate in the     Practice Self-Regulation (PS-R) (treatment) relative to the offer to participate in the     Therapy Practice Group (control) on increasing knowledge of sexual health and the impact of     trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors nine     months after the end of treatment.   "
25045|NCT02957864|"     Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV.     Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug     of Tenofovir which has not been associated with renal toxicity and may therefore be a good     substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another     drug that can be used for the treatment of HIV and is not associated with renal toxicity.      In this study the investigators will compare the effect on renal function of a switch from     TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.   "
25046|NCT02957851|"     To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen     50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on     therapy to chronic analgesic treatments, on average pain intensity in patients with chronic     peripheral neuropathic pain. A total of 250 randomised patients to be included in all the     participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments   "
25047|NCT02957838|"     The purpose of this crossover study is to determine whether nutritional supplementation of     C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We     will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics.     Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a     bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells     will be scored by immunofluorescence and FACS analysis.   "
25048|NCT02957825|"     The aim of this study is to test the hypothesis that continuous wireless monitoring on the     postsurgical ward will improve patient outcome, measured as disability-free survival at three     months after surgery. Further, the investigators hypothesize that this tight control regimen     decreases length of hospital stay and treatment costs in patients with complications.   "
25050|NCT02957799|"     The purpose of this study is to address the United States Office of AIDS Research highest     priorities: improving the workforce, reducing health disparities, and addressing HIV     comorbidities. UCLA will randomize the government-funded community health workers (CHW) from     16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the     Accountable Condition (AC) in which additional monitoring and accountability systems that     Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani     training, but ongoing supervision and monitoring consistent with local government practices.   "
25051|NCT02957786|"     To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural     support compared to varenicline plus behavioural support for smoking cessation, in indigenous     Māori (or family of Māori) who smoke and are motivated to quit.   "
25052|NCT02957773|"     This project will be a randomised controlled trial to investigate the effectiveness of an     integrated programme by using social art activity (SA) and exercise, for instance, Qigong     (QG, a traditional Chinese exercise) as a therapeutic medium.      This integrated programme aims to increase the well-being and reduce the depressive symptoms     that are frequently ascertained in older people who live in nursing homes. The combination of     SA and QG might be more beneficial to older people than either individual activity on its     own, given that they are addressing different areas of functioning. The art activity focuses     on self-expression in non-verbal activity using fine motor movement, whereas physical     exercise like Qigong focuses on awareness of breathing and a calm state of mind. This is to     help the older person achieve mental and physical relaxation by using gross motor movement.     When the interventions are combined by utilising Qigong ahead of the art activities (thus,     including both fine and gross motor movements) older people will reach a state of mental and     physical relaxation, and moreover, will be able to express their feelings more simply in the     social art activities.   "
25053|NCT02957760|"     The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in     particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is     no effective systemic treatment of this condition. An increase in the adhesion of     erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with     overexpression of membrane phosphatidylserine   "
25054|NCT02957747|"     Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to     attempted or completed rape) is a significant social and public health problem among women     Veterans. For women Veterans, lifetime ST can occur prior to, during or after military     service. ST is associated with multiple difficulties and risks, including posttraumatic     stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an     effective, integrated, and low-cost intervention that targets ST-related risks for women     Veterans with lifetime ST would advance clinical care for these vulnerable women.      This research will develop and assess a computer-delivered intervention (Safety and Health     Experiences Program; SHE) that will provide a screening and brief behavior intervention for     women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address     interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD).     SHE will be designed to provide individualized assessment, feedback, and referrals for women     Veterans with any lifetime ST. SHE will take place within a primary care setting. Primary     care visits are frequent points of health care contact for women Veterans making the visit     itself the ideal, and possibly only, opportunity to provide behavioral interventions.      This study will lay the groundwork for a larger clinical trial of the SHE program in multiple     VA primary care settings. If effective, the intervention, SHE, represents an innovative and     low cost service for early identification and intervention that could be implemented     nationwide with ease and speed to address the needs of women Veterans with lifetime ST. The     long-term goal of the project is to make a significant impact on advancing health services     research by introducing and testing a novel and potentially powerful service tool that may     improve service delivery to address the co-occurring health concerns for women Veterans with     any lifetime ST.   "
25055|NCT02957734|"     LAVA Ultimate composite restorations will be used as restorative material to reconstruct     severely worn dentitions.   "
25056|NCT02957721|"     The following are hypothesized:        1. The Diabetes Engagement and Activation Platform (DEAP) can be integrated into primary          care workflow to facilitate the care of patients with type 2 diabetes.        2. The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.        3. The DEAP intervention will enhance patient activation and improve type 2 diabetes self          management and glucose control   "
25064|NCT02957617|"     The primary objective of the study is to evaluate the long-term safety and tolerability of     BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A     secondary objective is to investigate the maintenance of effect during long-term treatment     with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline     will be prior to randomization into Study 1014802-203. Another secondary objective is to     evaluate the impact of treatment with BIIB074 on quality of life (QoL).   "
25065|NCT02957604|"     This is a prospective observational registry study to evaluate fetal, infant and childhood     outcomes in women exposed to evolocumab during pregnancy   "
25066|NCT02957591|"     Recent research demonstrates that the composition of the gut microbiome is a master regulator     of key neurophysiological processes that are affected in depression. Indeed, contemporary     studies showed that faecal microbiota is altered in patients with major depressive disorder     (MDD). Furthermore, it has also been shown that supplementation of probiotics ameliorated     depressive symptoms in unmedicated patients with mild to moderate depression. However, no     study has yet explored the efficacy of a probiotic-based therapy in patients with severe MDD     in addition to a standard antidepressant treatment. As dietary and lifestyle interventions     may be a desirable, effective, pragmatical and non-stigmatizing prevention and adjuvant     therapy (in addition to antidepressant treatment) in depression, this project is aimed at     investigating for the first time if probiotic supplementation compared to a placebo treatment     improves the effect of standard antidepressant medication on depressive symptoms (i.e. better     and faster remission) in patients with severe MDD. Furthermore, this study will further test     if probiotic supplementation modulates immune signalling and inflammatory processes     (macrophage migration inhibitory factor and interleukin 1 beta),     hypothalamic-pituitaryadrenal (HPA) axis responses (saliva cortisol), neurogenesis     (brain-derived neurotrophic factor (BDNF) expression), the release of appetite-regulating     hormones (leptin and ghrelin), the composition of gut microbiota (in particular levels of     Enterobacteriaceae, Alistipes and Faecalibacterium) and brain perfusion, structure and     activation and if these changes are associated with the probiotic-induced effect on     depressive symptoms.   "
25067|NCT02957578|"     This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with     the AventaMed Solo Tympanostomy Tube Device (TTD)   "
25068|NCT02957565|"     The goal of this research study is to learn how patients feel about their doctors' attitudes     toward supportive care and treatment options for advanced cancer patients.   "
25069|NCT02957552|"     Since the introduction of calcineurin-based immunosuppression, patient and graft survival in     pediatric liver transplantation (LT) improved significantly. However, in contrast,     calcineurin inhibitor (CNI) toxicity leads to significant morbidity and impairs quality of     life for recipients. Moreover, CNI cannot prevent long-term allograft inflammation and     fibrosis.      Mesenchymal stem (stromal) cells (MSC) have potent immunomodulatory properties potentially     promoting allograft tolerance and ameliorating toxicity of exposure to high dose CNI.     Previous trials for non-solid organ transplant indications have shown an excellent safety     profile of intravenous MSC application. The MYSTEP1 trial aims to investigate safety and     benefits portal and intravenous MSC infusion in pediatric LT.   "
25070|NCT02957539|"     Three of every four Veterans are overweight or obese, and weight loss is associated with     reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately effective     but only reaches a small percentage of overweight Veterans. This proposed study will test     whether a patient incentive program that gives Veterans non-financial incentives, such as     Seattle Mariners baseball tickets, for losing one pound per week over 16 weeks is effective.     An effective patient-incentive program could help more Veterans lose weight without requiring     a substantial increase in VA staff.   "
25071|NCT02957526|"     The purpose of this study will be to test the use of a web-based mobile application (app)     initiated at the time of hospital discharge to provide real-time monitoring and better     management of treatment-related adverse symptoms among patients with hormone-receptor     positive breast cancer and a new aromatase inhibitor prescription.   "
25072|NCT02957513|"     The overall goal of this study is to compare how well motivational messages (text messages     from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes     education materials (provided at the doctor's office) work to help African-American adults     with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is difficult     when you have diabetes, especially when patients have other medical conditions, their     diabetes is uncontrolled, and when they live in an area without many primary care doctors.     Many studies have show that encouraging text messages from the doctor's office and health     coaches can help people take better care of themselves. But before primary care clinics     around the country start trying to send texts, hire health coaches, or provide additional     educational materials it is critical for them to know which approach is more likely to help.      This study will assign African-American diabetics to either text messages, health coaches, or     enhanced care to find out which one works better. The investigators especially want to find     out if one works better for people at highest risk. Lastly, the investigators want to find     out if messages or coaches help people improve their blood sugar, quality of life, and their     feelings about primary care.      The study will test messages, coaches, and enhanced care side by side in primary care     doctors' offices. The messaging and coaching programs will give patients pretty much the same     information, but in different ways. The text messages will be written carefully based on each     patient's needs and interests. The coaches will be trained in how to help people get     motivated and work to reach their health goals.      This study will include 1000 African-American adults, ages 35-75, with uncontrolled diabetes     and one or more additional chronic condition, living in medically underserved communities.     People will have to have a cell phone or smart phone with texting capability and be able to     use it to participate. 400 participants will get messages, 400 will get coaches, and 200 will     receive enhanced care.      The investigators will be able to tell if messages and coaches work by seeing if people     improve their diabetes self-care decisions, and if their blood sugar, quality of life, and     feelings about primary care get better. The long-term study goal is to get primary care     clinics all over the country to start using motivational messages or health coaches if they     work well.   "
25073|NCT02957500|"     The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an     antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.   "
25074|NCT02957487|"     The aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway are     to assess the clinical outcomes of patients with an edentate upper jaw having been treated     with a removable full prosthesis supported by 3 implants to restore function and aesthetics.     Clinical variables beyond implant dimensions and intraoral location, such as recall routines,     maintenance needs, patient satisfaction and quality of life, will also be appraised and     contrasted with an aim to elucidate their association with clinical outcomes. Specific     evaluation will be done with regard to the following outcome criteria:        -  crestal bone levels and periodontal conditions around implants        -  incidence rates of biological, technical, traumatic failures / complications related to          implants        -  incidence rates of biological, technical, mechanical, esthetic failures/complications          with prosthesis and prosthetic components A secondary objective is to identify the          different risk factors for biological failures / complications, including the influence          of medical conditions and tobacco use.   "
25075|NCT02957474|"     This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to     compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co     administration with omeprazole, a proton pump inhibitor.      The study will consist of a screening phase, a baseline phase, four treatment periods, and a     follow up phone call five days (± 1 day) after discharge.   "
25076|NCT02957461|"     This study is designed to validate the performance of the algorithms to be used in future     commercial device.   "
25077|NCT02957448|"     This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of     BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)   "
25078|NCT02957435|"     The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of     eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of     50mg) in male and female healthy subjects under fasting condition.   "
25079|NCT02957422|"     The purpose of this study is to learn if increased dairy food consumption helps brain health     in older adults by protecting nerve cells from damage.   "
25080|NCT02957409|"     The purpose of the study is to describe the heart failure with reduced ejection fraction     (HFrEF) patient population receiving sacubitril/valsartan treatment.   "
25081|NCT02957396|"     Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic     kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics     of a novel liquid formulation for the treatment of children in comparison to the adult tablet     formulation.   "
25092|NCT02957253|"     This study compare the effects of traditional follow-up by physician with a combined     follow-up alternately by physician and nurse-led clinic. The main variable is; health related     quality of Life. Participants are randomized into control group or intervention group.   "
25164|NCT02956291|"     The purpose of the research study is to test new methods that could improve diagnosis and     assessment of brain tumors. One of these methods is a new MR (magnetic resonance) imaging     technique called magnetic resonance fingerprinting (MRF), which allows for rapidly scanning     the patient and provides quantitative information on tumor tissue. The investigators will     compare the data gathered from MR Fingerprinting with other imaging tests, clinical     information, treatment details and biopsy results to evaluate the accuracy of this new     technique.   "
25082|NCT02957383|"     Light exposure is on the rise in recent years. In large part because of unintentional     illumination from screens that emit light directly into the eyes. Millions of computers,     tablets, televisions, and smart-phones are sold worldwide every month and the usage time of     these devices is increasing constantly. Today, people are exposed to ongoing light exposure     from these device screens, emitting short wave length (SWL) during day and night hours,     whether as active or passive users. In sum, artificial light at night (ALAN) seem to affect     human circadian rhythmicity (melatonin and thermoregulation) and sleep, with two major     factors. First, wavelength of light, with SWL being most detrimental to sleep and rhythms,     when compared to LWL (Brianard et al., 2001). Second, a dose-response relationship exists     between increasing light intensity and poorer sleep/circadian rhythms (Brianard et al., 1988;     West et al., 2011).      Based on existing knowledge, we hypothesize that when compared to long wavelength LWL     illumination, short wavelength SWL illumination from computer screen will have a more     damaging effect on melatonin (MLT) production and secretion, interfering body temperature     regulation and affecting sleep quality, efficiency and sleep architecture. In addition, we     hypothesized that intensity of the screen illumination will play another important factor on     these outcomes, we assume that high intensity compared to low intensity will have more     damaging effect on: melatonin, thermoregulation and sleep.   "
25083|NCT02957370|"     This project focuses on developing specific and sensitive detectors of biomarker-based     signatures associated with diagnosed and recurrent bladder cancer.   "
25084|NCT02957357|"     Through this study, the investigators seek to identify the benefits (improved survival) and     harms (more procedures, more treatment, side effects, and quality-of-life impact) from     different surveillance frequencies—every three vs. six vs. 12 months. Using the National     Cancer Database and quality-of-life data from a large group of prostate cancer survivors, the     investigators aim to compare survival, procedures/tests, treatments, and side effects in     prostate cancer survivors who are followed with alternative surveillance frequencies and     compare quality-of-life outcomes. The overall goal of the study is to provide high-quality     data that will allow development of a personalized, risk-based tailored approach to     post-treatment surveillance for prostate cancer.   "
25085|NCT02957344|"     Through an online survey, participants will be shown different visual presentations of     vaccination data related to schools and child care centers. Participants will rate how     important this information is when thinking about their child's health and school choice.     Participants will also be asked survey questions about their knowledge of Colorado state     vaccination legislation, their opinions and practices related to childhood vaccinations, and     their views of a Zika virus vaccine.   "
25086|NCT02957331|"     The purpose of this study is test the effect of beta-adrenergic blockade on mortality in     patients with traumatic brain injury with the hypothesis being that the addition of beta     blockade to the treatment regime of this patient population will lower mortality and supress     the catecholamine surge that accompanies traumatic brain injury as compared to those who do     not receive beta blockade.      Half the patients will be randomized to receive propranolol and half will be randomized to     receive no beta blocker.   "
25087|NCT02957318|"     Results have indicated that some dietary fibers increase fecal fat excretion and particularly     viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may     contribute to body weight management.      Aim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato     pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control     (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of     secondary endpoints are investigated.   "
25088|NCT02957305|"     Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg     of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been     recommended by some international guidelines . So far, there are no recent studies comparing     cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg). If     cervical ripening is similar between these two regimens, costs reductions and lower side     effects may be issued without losing quality of cervix dilatation.   "
25121|NCT02956850|"     This sponsor-open, investigator- and participant-blinded, multi-center study will assess the     safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy     participants and in participants with chronic hepatitis B. Part I will be conducted in two     portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include     only healthy volunteers. Part II will commence after completion of the MAD portion of Part I     and will include only Chronic Hepatitis B (CHB) participants.   "
33702|NCT02844660|"     A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the     safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the     treatment of chronic, non-healing diabetic foot ulcers (DFUs)   "
25089|NCT02957292|"     The intrauterine device (IUD) is a long-term birth control method that has demonstrated high     contraceptive efficacy and effectiveness due to its high compliance, adherence and     persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive     age.      Side effects are the main reason for IUD use discontinuation. The most common reasons for     copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and     dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and     amenorrhea.      In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There     are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing     the IUD 13,5mg Levonorgestrel with classic copper IUDs.      The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual     bleeding pattern with fewer days than Copper 380 mm2 IUD users.      This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative,     parallel controled trial.   "
25090|NCT02957279|"     The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced     infection. The primary objectives of this study are to compare the changes of peripheral     blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.   "
25091|NCT02957266|"     The purpose of this study is to define an effectiveness of concurrent chemoradiotherapy of     cervical cancer patients treated by VMAT (volumetric arc therapy) based external beam     radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial     brachytherapy.   "
25093|NCT02957240|"     Nearly 2 out of 10 women will sustain a distal forearm fracture throughout their     lifespan.Recent longitudinal studies illustrate that as many as 1/3 of all persons who     undergo closed reduction and casting for distal radius fractures (DRF) go on to develop type     1 complex regional pain syndrome (CRPS). Graded motor imagery (i.e., motor imagery and mirror     therapy), a movement representation technique, is strongly supported in the literature as a     treatment of CRPS and has recently been suggested as a potential strategy to prevent its     onset. Other complications include disability, wrist/forearm tightness and sensorimotor     changes.      The investigators propose that an early intervention protocol which includes graded motor     imagery (GMI) will improve the pain, functional and upper limb sensorimotor outcomes of     persons following closed reduction and casting of DRF relative to a standard of care     intervention.   "
25094|NCT02957227|"     This study evaluates the use of an EEG device using Event Related Potentials to help diagnose     Alzheimer's Disease in the outpatient clinical setting.   "
25095|NCT02957214|"     The purpose of this study is to obtain imaging biomarkers based on changes in activity     patterns and changes in brain connectivity obtained with the analysis of functional magnetic     resonance imaging (fMRI) and tractography that are related to chronic pelvic pain   "
25096|NCT02957201|"     All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen     ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be     identified and reviewed in cardiology clinics. These patients will be placed on waiting list     to undergo the procedure. Patient-participants will be consented on the date of admission for     device closure implantation.      The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and     10 patients undergoing LAA closure. EPC will be measured on the day of the device     implantation, day 0 and prior to discharge on day 1.      Patient participants are admitted overnight after the device closure implantation. Then on     subsequent out patient cardiology research clinic follow appointments on days (3-4) and     (7-8).   "
25097|NCT02957188|"     The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA) and     13C-arachidonic acid (AA) in young and older participants   "
25098|NCT02957175|"     The purpose of this study is to develop an immune-phenotype based prediction of postoperative     SIRS in patients undergoing open heart surgery.   "
25099|NCT02957162|"     Cardiovascular disease is a major cause of morbidity and mortality worldwide. There are a     number of risk factors for coronary artery disease and all to often patients admitted with an     acute coronary syndrome have these comorbidities.      The main stay of treatment of such patients is to perform coronary angiography and if     required coronary angioplasty.      Previous studies have shown a link between endothelial progenitor cell (EPC) count, coronary     artery disease and statin therapy or loading, however these studies have excluded patients     with significant comorbidities and therefore have not truly represented real life patients.     This pilot study will assess EPC response in patients that are able to undergo coronary     intervention as part of their normal clinical management under current guidelines regardless     of pre-existing comorbidities. The research team believe this will allow representation of     real world patients.   "
25122|NCT02956837|"     The purpose of this study is to rank different RSV vaccine dosages of antigen (or     formulations) based on safety/reactogenicity and immune response data. The formulations     eliciting strong immune responses while maintaining an acceptable safety profile will be     considered for further evaluation, including in studies vaccinating pregnant women.   "
25148|NCT02956499|"     First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose     (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects. The     SAD portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a     total of approximately 48 healthy subjects. The MAD portion of the study will enroll four     cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy     subjects.   "
49005|NCT02644174|"     In this prospective study we will evaluate the changes in respiratory physiology occurring in     morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center     of Israel (SCMCI).   "
25101|NCT02957136|"     This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing     for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza     medication use in emergency department (ED) patients with symptoms of influenza-like illness     (ILI) and/or upper respiratory infection (URI). The intervention is a rapid,     multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory     Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample     collection. Randomization is at the individual patient level. Intervention patients will     receive usual care plus the rapid multi-respiratory pathogen test. Control patients will     receive physician-directed usual care without the rapid, multi-respiratory pathogen test,     which may include but is not limited to no testing, point-of-care influenza testing, or     delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary     outcome is antibiotic administration or prescription during the initial ED episode of care.     The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be     associated with a ≥15% reduction in antibiotic use in intervention patients, relative to     control patients (usual care). The investigators secondary outcome is administration or     prescription of antivirals during the initial ED episode of care. The investigators secondary     hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza     medication use in intervention patients (composite rate of anti-influenza treatment in     positive patients and non-use of anti-influenza treatment in negative patients), relative to     control patients receiving usual care alone.   "
25149|NCT02956486|"     The name of this trial is MissionAD1. This 24-month treatment, multicenter, double-blind,     placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's     Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early     stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat     (proposed international nonproprietary name [INN]) (E2609).   "
25150|NCT02956473|"     This research study involves the use of a common breast imaging modality (magnetic resonance     imaging, 'MRI') and is investigating its role in evaluating treatment for breast cancer when     it is performed with the patient in a new position (lying on one's back) as opposed to in the     standard position (lying on one's stomach).   "
25102|NCT02957123|"     The investigators have designed an innovative proof-of-concept trial designed to provide data     as to whether the treatment/rehabilitation efficacy and functional outcome of patients with     organic brain syndrome are improved with intranasal inhalations of bioactive factors (BF),     produced by autologous M2 macrophages (auto-M2-BFs). The rationale for this approach is the     ability of central nervous system to repair and the important role of macrophages in the     regulation of this process. It was found that type 2 macrophages have anti-inflammatory and     reparative potential, whereas M1 cells possess pro-inflammatory and neurotoxic effects.     Action of M2 macrophages is largely realized through the production a wide variety of     bioactive factors (cytokines, chemokines, growth factors, neuropeptides, microvesicles etc)     that inhibit inflammation, protect neurons from apoptosis, stimulate neurogenesis, the growth     and remyelination of axons, the formation of new synapses and activate angiogenesis. This     study uses auto-M2-BFs, as therapeutic agents and intranasal administration focusing on nose     to brain transport, as a mode of delivery. Expected clinical effects in treated subjects:     improvement of cognitive functions (memory, language, attention); correction of focal     neurological deficit (paresis, spasticity, sensory disorders); reduction vestibular/ataxic     disorders (vertigo, unsteadiness when walking); reduction of headaches; reduction of asthenia     (weakness, fatigue); correction of emotional disorders (anxiety, depression).   "
25103|NCT02957110|"     The purpose of this study is to investigate whether daily laughter frequency is associated     with pain intensity and emotional state ratings in individuals who have fibromyalgia     syndrome.   "
25104|NCT02957097|"     The purpose of this study is to assess the effectiveness of pre-operative administration of     gabapentin 900 mg in management of acute post-operative pain in patients undergoing oral and     maxillofacial surgical procedures.   "
25105|NCT02957084|"     In this prospective, open cohort study the diagnostic value of tests based on neck anatomy in     predicting difficult laryngoscopy was assessed.      The anatomic features of the neck measured were head extension, mouth opening, upper lip     bite, Mallampati class, thyromental distance, sternomental distance, ratio of height to     thyromental, neck circumference, thyrosternal distance, hyomental distance at full head     extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental     distance and ratio of hyomental distance FHE to hyomental distance NP.   "
25106|NCT02957058|"     To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma     recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with     thermal treatment applied to the defect margin. The primary aim of the study will be to     ensure the safety of this approach and there will be constant monitoring to ensure that this     is the case.   "
25107|NCT02957045|"     Pressure generated by cough is an expression of expiratory muscle strength. Cough pressure     (Pcough) is usually measured with gastric and/or esophageal catheters, but these are often     either inconvenient or uncomfortable for the patient. The aim of this study was to evaluate     whether central venous, vesical or rectal catheters could be useful to measure cough     pressures as alternative sites to standard esophageal and gastric balloons.   "
25108|NCT02957032|"     Phase I, open label, non-randomized, multicenter, prospective dose escalation study of F16IL2     in combination with very low-dose cytarabine in subjects with acute myeloid leukemia relapse     after allogeneic hematopoietic stem cell transplantation (alloHSCT).   "
25109|NCT02957019|"     Phase I/II, open-label, multicenter, prospective study.   "
25110|NCT02957006|"     Currently loop recorders diagnose arrhythmias and send automatic alerts to physicians based     on R to R relationships only. We believe arrhythmia diagnostics could be improved if accurate     detection of P and T waves as well as QRS complexes were possible.      There is no technique available for long term outpatient monitoring of QT intervals for     patient at risk of torsade de pointes when receiving QT prolonging drugs. We believe that if     an accurate T wave detection algorithm were developed loop recorders could be used to monitor     the QT interval, and perhaps even provide alerts for patients at risk.      The objective of this study is to see if an algorithm can be developed to accurately define P     and T waves using data from an implantable loop recorder.   "
25111|NCT02956993|"     The research study is designed to assess the technical feasibility and safety of a     perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal     popliteal, tibial or peroneal arteries immediately following successful angioplasty.   "
25112|NCT02956980|"     Differences in pDCs function related to gender have been demonstrated in adults but have     never been addressed in children. Yet, differences in immune responses related to gender also     exist in children, both in responses to pathogens and susceptibility to autoimmune diseases.     The investigators suppose that these differences are partly linked to difference in pDCs     functions. This study aim is to compare pDCs functions in children based on gender and     pubertal status. This study will be performed in healthy children, boys with Klinefelter     syndrome and girls with Turner syndrome.   "
25114|NCT02956954|"     Anderson Fabry disease (AFD) is an X-linked lysosomal storage disorder caused by a deficiency     of the enzyme alpha-galactosidase. AFD can involve various organs and lead to a series of     clinical abnormalities. Left ventricular hypertrophy in middle-aged men is one of its life     threatening complications. It was shown that pending the absence of myocardial replacement     fibrosis, substitution therapy could improve myocardial morphology and function as well as     exercise capacity. Today, there is no available marker of the efficacy of the treatment on     the heart morphology and function.      The T1 time (or longitudinal relaxation time) is one of the major components of the image     formation in Magnetic Resonance Imaging (along with T2 time and proton density). Several     techniques have been described to assess the myocardial T1-time.      One of them called MOLLI (Modified Look Locker Inversion Recovery), was made available in     research centres by the Siemens company. In a study published in 2013, Sado et al. showed in     a series of various conditions (hypertension, AFD, hypertrophic cardiomyopathy, AL     amyloidosis, aortic stenosis and healthy volunteers) that a septal T1 below a threshold of     940ms could discriminate AFD patients. No overlap was shown with other conditions in this     study. Our experience with T1 mapping supports that finding (even though our threshold could     be slightly different), and we could recently detect by MRI a number of AFD patients, some of     them with hypertrophy, some others without hypertrophy. The effect of Replagal® on the T1     relaxation time remains unknown.      The purpose of that study was to follow-up the heart morphology, function and myocardial T1     relaxation time in a population of treated/untreated patients.   "
25115|NCT02956941|"     A cluster randomized controlled trial was chosen to exploit the robustness of this design to     help ascertain the efficacy of the BCC intervention compared to the routine dietary practice.     This protocol was developed according to the guidelines of the Consolidated Standards of     Reporting Trials (CONSORT) statement extension for cluster randomized trials.      The present study is aims to evaluate the effect of improving micronutrient intake through     behavior change communication intervention on nutritional status and academic performance of     school age children. Moreover, it may help to prevent or mitigate malnutrition. However to     the best knowledge of the authors, BCC intervention using posters, and lecture for school     teachers and students have not yet been empirically tested generally in Ethiopia,     specifically in the study area context. The present intervention is unique in combining the     use of conventional BCC intervention tools, that is, lecture and posters as reminder for     intervention reinforcement.   "
25116|NCT02956915|"     Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the     first-in-man TAVI performed in 2002. With increasing experience and improvements in valve     design, the minimalist approach to transfemoral TAVI (using local anesthesia and     fluoroscopic guidance) has become an attractive concept, and the technical feasibility of     this approach has been well documented.      While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the     FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry     (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time     period of 2007 to 2012. More contemporary data from other centers has been published showing     that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly     minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains     indeterminate with a lack of formal consensus.      Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential     advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly     patients in addition to cost-saving benefits. Rouen University Hospital has previously     published a retrospective study on the feasibility and safety of early discharge, in which     discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our     patients. Pre-existing pacemaker and the absence of acute kidney injury were independent     predictors of a successful early discharge. Moreover, in a prospective study, Rouen     University Hospital recently shown that early discharge afterelective TF-TAVI with     SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no     evident compromise in safety. Factors associated with failure of early discharge were     postprocedural blood transfusion and permanent pacemaker implantation. But currently, there     are no guidelines for the length of stay after a TF-TAVI.   "
25117|NCT02956902|"     This study tests whether people receiving clinician support to use a mobile application on     their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than     those who do not. Half of the participants will receive the clinician supported smartphone     application intervention and the other half will remain on the waiting list.   "
25118|NCT02956889|"     This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy     and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not     amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).      The recruitment period is expected to be approximately 24 months. The trial will consist of a     Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated     with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24     weeks).      The study will end 14 months after start of treatment of the last patient enrolled and     evaluable according to primary end point.   "
25119|NCT02956876|"     With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France     according to the latest report from the Institut national du Cancer (INCa). Second leading     cause of cancer death in men, its management is a public health problem. According to     projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in     digestive oncology. These projections can be concluded that the demand for care will continue     to be growing.      Medical advances and societal leading to increased life expectancy, have operated a mutation     of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases.     These changes are causing new challenges for the health system.      To address this problem, it is asked health professionals to adapt the organization of health     care delivery to improve efficiency, in a constrained economic environment. To this end,     action 4.1 of the cancer plan includes the creation of clinical nursing profession, a     proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will     be empowered to ensure, under certain conditions, prescription treatments protocolized of     follow-up tests, further treatment and support, as well as the extension or adaptation of     specific treatments.      This project is a first step, in France, in thinking around new organizations in the supply     of care in oncology.      For patients, strengthening their monitoring during chemotherapy, will better know their     tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects     will help reduce the use of emergency care.      The establishment of such a practitioner will free medical time to handle the most complex     patients and perform tasks related to research.      For hospital pharmacies this type of organization will optimize their productivity by     anticipating orders for chemotherapy pockets.      This project represents an opportunity to demonstrate the added value of advanced practice     nurses in France in the health system and particularly in oncology. It also adds value to     clinical expertise nurse and register the profession in the research.      The hypothesis is that the quality and safety of care provided by a nurse practitioner are     equivalent to those provided by a doctor at follow-up of patients with gastrointestinal     cancer, treated with intravenous chemotherapy.   "
25120|NCT02956863|"     The purpose of this study is to determine whether manipulative osteopathic treatment     associated exercises improves pain and function in individuals with chronic non-specific neck     pain   "
25146|NCT02956525|"     To evaluate the interaction of food on the pharmacokinetics of Dexibuprofen 200 mg (Apsen     Pharmaceuticals A / S.) after single dose oral administration to healthy subjects of both     sexes, under fasting and fed conditions.   "
25123|NCT02956824|"     Prospective multicenter study assessing the incidence of inflammatory and structural lesions     seen on MRI of the SI joints in a consecutive population of women aged 18-50 years old.      The study hypothesis is SpA may be misdiagnosed on MRI in post partum women due to increased     stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show     lesions that could mimics axial spondyloarthritis. The primary objective of this study is to     determine the incidence of SI lesions seen at MRI in women. The secondary objectives are to     compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints     and to determine the factors associated with inflammatory or structural changes of the SI     joints in a population of women. the investigators will especially compare the population of     women within a year after childbirth versus the population of women who never gave birth or     who gave birth over 24 months ago or more.   "
25151|NCT02956460|"     Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1     month dispensing study (2 weeks each lens pair)   "
25152|NCT02956447|"     The goal of this project is to explore the use of exogenous pulsatile kisspeptin as a     therapeutic alternative for patients with hyperprolactinemia who are intolerant to current     therapies.   "
25153|NCT02956434|"     This study aims to test a brief family intervention (the BFI) to enhance     individually-delivered PTSD treatment for Veterans.   "
25165|NCT02956278|"     Subjects will undergo a placebo and allopurinol phase to better understand the effects of the     reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.   "
25124|NCT02956811|"     Left ventricular hypertrophy (LVH) is common in people with type 2 diabetes (70%) and is the     strongest independent risk factor for cardiovascular events and all-cause mortality that     there is. It is worse than triple vessel coronary disease. LVH often occurs in patients with     normal blood pressures (BP). Apart from BP, the other three main factors causing LVH are     insulin resistance, obesity and cardiac preload. Dapagliflozin reduces ALL four factors known     to promote LVH i.e. Dapagliflozin reduces weight, glycaemia, preload and blood pressure and     is therefore the ideal agent to reduce LVH since it uniquely attacks all four known mediators     of LVH. This trial will investigate the ability of dapagliflozin to regress LVH in 64     participants with normotensive diabetes. This will be done by seeing if dapagliflozin reduces     left ventricular mass as measured by cardiac magnetic resonance imaging (MRI). This trial may     identify a novel way to reduce the strong independent risk factor of LVH which often persists     despite optimum medical therapy in patients with diabetes. If dapagliflozin does reduce LVH,     this would be a key sign of which subgroup of patients with diabetes (those with LVH) should     be especially targeted with dapagliflozin.      64 participants with type 2 diabetes and LVH will be recruited through the Scottish Diabetes     Research Network (SDRN), Scottish Primary Care Research Network (SPCRN) and other routes, in     this single centre study. Participants will be randomised to receive either 10mg     dapagliflozin or placebo daily for 12 months. Cardiac MRI will be performed at baseline and     at 12 months, this will be assessed for the primary outcome of change in left ventricular     mass. Secondary outcomes will examine change in 24 hour blood pressure and weight.   "
25125|NCT02956798|"     The proposed study is a phase II randomized trial testing an innovative concept of comparing     local therapy to systemic therapy, e.g. pazopanib, in patients with newly diagnosed limited     metastatic RCC. We hypothesize that local therapy can prolong progression-free survival for     patients with limited metastasis, and delaying the initiation of systemic therapy does not     adversely affect survival. Patient will be stratified by Heng's criteria. Patients that are     curable by metastatectomy as well as patients with poor prognosis and high chance of disease     dissemination according to the prognostic factors will be excluded.   "
25126|NCT02956785|"     The aim of this study is to compare three different regimens for continuation of induction of     labor after no spontaneous or artificial rupture of membranes could be achieved after first     24 hours post-insertion of Dinoprostone   "
25127|NCT02956772|"     A multicentre, randomized, open-label, parallel-group, active controlled study.   "
25128|NCT02956759|"     To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very     severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until     the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in     China.      Interview data from some patients and survey data from ophthalmologists in the study     hospitals will help determine acceptability of early treatment, and how to overcome barriers     to increased use of this option.   "
25129|NCT02956746|"     This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi)     and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin     (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023,     RVi+RIG, RVa+SYN023 and RVa+RIG. The initial dose of RVi and RVa will be co-administered with     either RIG or SYN023). Rabies virus neutralizing activity (RVNA) and blood levels of SYN023     will be measured for the remainder of the trial while the rest of the five RVi and RVa doses     are given. The study will last 112 days. SYN023 concentrations and anti-SYN023 antibodies     will also be measured.   "
25130|NCT02956733|"     The fasciotomy incisions lead to large, unsightly, chronic wounds after surgical     intervention. The classic management was split thickness skin grafting but it leads to     insensate skin with 23% of people upset by the appearance of the wound and 12% forced to     changed occupation. Since no skin loss has occurred with the fasciotomy and utilizing the     dermal properties of creep, stress relaxation and load cycling closure can be achieved in a     better way. Our hypothesis is that using dermatotraction approximation could be done using     inexpensive equipment readily available in any standard operating room.   "
25131|NCT02956720|"     Prospective, open label, self - controlled, single arm, clinical study to assess the     performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for     circumference reduction versus self-control.   "
25132|NCT02956707|"     Little is known regarding the incidence and clinical impact of AI in neonates during the     acute postoperative period following separation from CPB. In a randomized control pilot study     performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions     improved some postoperative outcomes, especially in those that acquired AI7. In an attempt to     further explore post-CPB AI, a retrospective analysis of data from this study was performed.     Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as     determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had     normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated     more hemodynamic instability, increased serum lactate and required more colloid resuscitation     in the immediate post-CPB period in the operating room. Recent evidence has begun to     highlight potential morbidity associated with perioperative steroid administration. Our     cardiac surgery program is changing clinical practice and ceasing to give preoperative     steroids to all patients (previously only neonatal CPB patients received preoperative     methylprednisolone). With the possibility that preoperative steroid administration, and not     CPB, primarily causes the high incidence of AI, it is prudent to further investigate the     benefit and/or harm of perioperative steroid administration   "
25154|NCT02956421|"     Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based     Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA     adjuvant. The primary objective of the study is to evaluate the efficacy and safety profile     of the vaccine composition in healthy adult volunteers under the accelerated regimen. The     secondary objective is to achieve higher seroconversion of the vaccine under accelerated     regimen at Day 7.   "
25177|NCT02956122|"     The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on     biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in     participants with acute GvHD with lower GI involvement.   "
25133|NCT02956694|"     The increasing prevalence of Alzheimer's disease and other forms of dementia causes new     challenges to ensure that healthcare decisions are informed by research evidence and reflect     what is important for seniors and their caregivers. Primary care providers point to a need     for more training on communication with families of seniors living with dementia, and on the     non-pharmacological health options that are often recommended before use of     medications.Therefore, the investigators will design and evaluate an intervention to train     primary healthcare providers on how to empower seniors with dementia and their caregivers in     making health-related decisions based on research evidence and on their preferences and     priorities. A distance professional training program on shared decision making will initially     be designed, comprising evidence summaries to be shared with patients living with dementia     and their caregivers who face difficult decisions. Patients with dementia, their caregivers     and healthcare providers, will then provide feedback on the training program, which will then     be improved following their suggestions. In a last step, the investigators will evaluate     whether this training program truly increases the participation of patients and their     caregivers in decision making, their comfort with the decision that they have made, and their     motivation and ability to control their life by taking care of their own health.   "
25134|NCT02956681|"     Recruitment for prevention, and early detection among health disparities populations     represents a major challenge in chronic disease control. This effect is magnified for     individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis.     Costs are typically high, particularly given the common practice of developing a single     outreach channel to address each disease or condition. In a randomized delayed intervention     control trial, the investigators tested a strategy to identify low-income women at high risk     for hereditary breast and ovarian cancer (HBOC) outside the clinical setting and refer them     to free genetic counseling.   "
25135|NCT02956668|"     Homonymous hemianopia is one of the most common symptoms following a neurologic damage and     has many negative effects on functional abilities and daily activities.      There are two main kind of restorative rehabilitation of hemianopia: border training, which     involves exercising vision at the edge of the damaged visual field, and blindsight     training, which is based on exercising the unconscious perceptual functions in the mild of     the blind hemifield.      In literature only border training effects were shown to be facilitated by transcranial     direct current stimulation (tDCS).      The investigators treat two patients with blindsight rehabilitation associated to tDCS over     parieto-occipital cortex. The two patients undergo a cycle of blindsight treatment associated     to tDCS and a cycle of blindsight training alone in inverted order.      Aim of the study is to investigate if the anodic stimulation of perilesional areas enhance     the improvement induced by blindsight rehabilitation treatment.   "
25136|NCT02956655|"     The purpose of this study is to evaluate Effect of Fasting Therapy on Blood Glucose Control     and Islet Function in Newly Diagnosed Type 2 Diabetic Patients.   "
25137|NCT02956642|"     This study is a two-arm randomized controlled trial in which participants will receive either     the Livongo Health system or iHealth glucose meter for measuring their blood glucose. The     study hypothesizes the use of the Livongo Health system results in a greater improvement in     A1c compared to standard blood glucose monitoring, as demonstrated by the iHealth     Bluetooth-enabled glucose meter.   "
25138|NCT02956629|"     This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug     combination regimen (uprifosbuvir [MK-3682] 450 mg + ruzasvir [RZR; MK-8408] 180 mg once     daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced     (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3,     GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy.     Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency     virus (HIV) co-infection will be enrolled.   "
25139|NCT02956616|"     To determine whether women randomized to an enhanced recovery program will have improved     postoperative outcomes including improved breastfeeding initiation and continuation,     reduction in hospital length of stay without compromising patient satisfaction in comparison     to standard postoperative recovery interventions.   "
25140|NCT02956603|"     The primary purpose of this study is to determine the extent to which the Regenerative     Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual     peripheral nerves) enables both the generation of high-performance motor control signals for     prosthetic limbs, and the input of sensory percepts by electrical stimulation.   "
25141|NCT02956590|"     This trial of pitavastatin will determine efficacy and safety in this high risk population     and provide evidence for clinicians to target this treatable risk factor to achieve an impact     on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular     disease.   "
25142|NCT02956577|"     The purpose of this study is to investigate the influence of micro- and macrovascular changes     on the cardiac function in relation to left ventricular function and coronary arteries during     one year in patients with type 2 diabetes.   "
25143|NCT02956564|"     Based on multi-center clinical research resources, a large-scale prospective cohort study     will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal     hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for     China's national conditions.   "
25144|NCT02956551|"     The study is aimed to the test the efficacy and safety of neoantigen-primed T cell therapy     for refractory non-small cell lung cancer.   "
25145|NCT02956538|"     With the development and application of biological agents, the treatment effect was     considerable degree improvement on refractory corn's disease. However, there are quite a part     of the CD patients lost response during treatment of using response. Moreover, due to various     reasons, there still a lot limited on the using of biological agents in China, that make     quite a part of the refractory CD patients lack of further medical treatment options. There     has been a RCT study which prove that thalidomide effect and safety on treating refractory CD     or who were lost response by using biological agents in Italy, but the object of study is     only limited in children and adolescents. There are some small sample studies also confirmed     the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT     evidence.   "
25155|NCT02956408|"     Vitamin D deficiency is common in the general population in the United States, but is more     common in overweight and obese children. Additionally, vitamin D levels are inversely     correlated with body mass index, hypertension, inflammatory markers and insulin resistance.     There are currently no clear guidelines regarding vitamin D replacement in obese but     otherwise healthy children. The Endocrine Society recommends that children with vitamin D     deficiency should take 2000 IU once a day for at least 6 weeks; however, they state that     obese children may need 2-3 times this dose in order to reach sufficient levels.      The goals of this study are:        1. To determine the prevalence of vitamin D sufficiency (>30 ng/mL), insufficiency (21-29          ng/mL); deficiency (10-19 ng/mL) and severe vitamin D deficiency (<10 ng/dL) in an obese          pediatric population (2-11 years) as measured by 25-hydroxyvitamin D.        2. To determine if vitamin D level correlates with percentage body fat by bioelectrical          impedance analysis and/or visceral fat by waist circumference in children ages 5 - 11          years.        3. To observe the effect of vitamin D replacement in obese children with vitamin D          deficiency using two different replacement dosage levels recommended by the Endocrine          Society over three months: 2000 IU once a day (general pediatric dose) vs 6000 IU once a          day (suggested obesity dose) in children between the ages of 5 - 11 years.        4. To measure vitamin D levels, bone markers, inflammatory markers and vitamin D binding          protein before and after vitamin D supplementation in children between the ages of 5 -          11 years. Analysis will be stratified by degree of obesity (Class I, Class II, Class          III) and season.   "
25156|NCT02956395|"     Background/Aims: Large scale adoption of integrated care for chronic patients constitutes a     key milestone to accelerate adaptation of current healthcare systems to the evolving needs     triggered by population ageing and high prevalence of chronic conditions. Lessons learnt from     deployment experiences are being disseminated as good practices. But, there is need for     further assessment of implementation strategies in real world scenarios. Moreover, progresses     achieved in disease-oriented integrated care cannot be automatically transferred to     management of complex chronic patients (CCP). The protocol addresses five aims: 1)     implementation of two integrated care interventions using a collaborative and adaptive case     management (ACM) approach (i) Community-based management of CCP; and, ii) Integrated care for     patients under long-term oxygen therapy (LTOT)); 2) adoption of information and communication     technologies (ICT) required to support collaborative ACM; 3) to evaluate the impact of     enhanced clinical health risk assessment and stratification; 5) to generate a roadmap for     regional adoption of the CCP program.      Methods/Design: the CCP program will be deployed in three healthcare sector of     Barcelona-Esquerra (AISBE) (520 k citizens) and in two other areas of Catalonia: Badalona     Serveis Assistencials (BSA) (420 k citizens) and Lleida (366 k citizens) following     Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for     evaluation purposes. The study also addresses the steps for scale-up of integrated care in     the entire Catalan region (7.5 M citizens). Observational studies with matched controls have     been planned for both Community-based management of CCP (n=3.000) and for Integrated care for     patients under LTOT (n=500). Moreover, clustered randomized controlled trials (RCT) are     planned on top of the observational studies to test specific questions (i.e. performance of     the ICT platform providing ACM functionalities). Main components of CCP program are: a)     patient stratification; b) comprehensive assessment strategies; c) ICT supported adaptive     Case management; d) Roadmap for regional adoption.      Hypothesis: the CCP program will generate guidelines for large scale deployment of the CCP     program, including transferability analysis, facilitating adoption of integrated care     services for management of multi-morbidity.   "
25158|NCT02956369|"     SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of     hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid     component (long-chain fatty acids). The goal of this combination is to achieve long-acting     delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release     of satiety-signals from intestinal cells, and consequently reducing appetite and lowering     food intake in humans.      Over a period of 6 weeks, volunteers will ingest SATIOSTAT as meal replacement at lunch and     as first course at dinner. Once before and after these 6 weeks the investigators will carry     out an oral glucose challenge, measure satiation hormones and examine faeces (gut     microbiota). Volunteers will fill in a food diary and a questionnaire for gastrointestinal     symptoms and quality of life. The whole study will take approximately 8-10 weeks.   "
25191|NCT02955940|"     The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib     plus background cancer therapy, or background cancer therapy alone to subjects from an     Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been     terminated.      This study will also provide another mechanism for reporting adverse events related to study     drug safety.   "
25217|NCT02955602|"     An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to     evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis     (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)   "
25159|NCT02956356|"     SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of     hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid     component (long-chain fatty acids). The goal of this combination is to achieve long-acting     delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release     of satiety-signals from intestinal cells, and consequently reducing appetite and lowering     food intake in humans.      Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and second     study day, volunteers receive a preload of either SATIOSTAT or a control and then an oral     glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured by     means of a breath test, and insulin, glucose and satiation hormones will be assessed. On the     third and fourth study day, volunteers receive a preload of either SATIOSTAT or a control and     are then presented a test meal. Total calorie intake is measured as well as subjective     feelings of satiation. In addition satiation hormones are measured.   "
25160|NCT02956343|"     In this trial the Preventives Heartbeats algorithm will be tested in two wearable devices for     its specificity and sensitivity to distinguish between AF and SR.   "
25161|NCT02956330|"     The purpose of this non interventional retrospective study is to continue to collect data     from patients following their completion of Protocol CLS 1003-201: Safety and Efficacy of     Suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Macular Edema Following     Retinal Vein Occlusion (ie, the parent study).   "
25162|NCT02956317|"     This is a randomized, double-blind, within-subject placebo controlled study to evaluate the     safety and efficacy of various doses of STP705 administered as intradermal Injection in     subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose, the     pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers common     to the scar formation pathway.   "
25402|NCT02953171|"     The aim of the present study is to assess the efficacy of two different probiotic products,     lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel     syndrome.   "
25166|NCT02956265|"     Actinic keratosis are of utmost medical and economical interest because of their high     prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their     important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin     sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining     carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids,     lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma     (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which     ones will spontaneously regress (it is supposed to be the case for 20 % of such     lesions);which ones will remain and which ones will develop into invasive carcinomas ?      A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis     orientation of such skin lesions could help improving diagnosis accuracy of the medical     practitioner's visual inspection:        -  In terms of sensitivity in order to potentially decrease the number of actinic keratosis          evolving towards invasive carcinoma,        -  In terms of specificity in order to potentially decrease useless resections and reduce          resection margins and therefore reduce scars surface.   "
25167|NCT02956252|"     The aim of this study is to compare early postoperative outcomes of unselected consecutive     patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.   "
25168|NCT02956239|"     This project will develop, test and produce a lightweight, cordless, battery driven and     rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The     study will evaluate its effectiveness compared to the current standard treatment     (cryocautery) when used as part of a screen and treat programme using Visual Inspection with     Acetic acid (VIA) in Sub Saharan Africa.   "
25169|NCT02956226|"     This study aims to assess the safety, tolerability and efficacy of cannabinoids mix     [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] for behavioral problems in     children and youth with ASD.   "
25170|NCT02956213|"     The investigators will conduct a randomized, controlled, double-blind, crossover trial to     determine whether the presence of a portable high-efficiency indoor air filter in the bedroom     reduces respiratory symptoms in former smokers compared with placebo. The primary outcomes     will be change in St. George's Respiratory Questionnaire - COPD (SGRQ-C) score associated     with using a portable high-efficiency indoor air filter during the study period. Secondary     outcomes of COPD exacerbations and hospitalizations, daily step counts, medication changes,     spirometry, and cardiovascular outcomes will also be assessed.   "
25171|NCT02956200|"     Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor     modulator fingolimod may be efficacious in attenuating brain inflammation and improving     clinical outcomes in patients with AIS as a single therapy beyond 4.5 hours of disease onset,     or in combination with alteplase within 4.5 hours of disease onset. So in this study the     investigators try to determine whether the addition of fingolimod, administered within 6     hours after the onset of symptoms in patients receiving alteplase bridging with mechanical     thrombectomy, improves radiologic and clinical outcomes.   "
25209|NCT02955706|"     clinical trial to assess the efficacy of Acetyl-L-carnitine   "
25210|NCT02955693|"     The purpose of this study is to determine how the organism affects MMF (metabolite of     dimethyl fumarate [DMF]) after single oral dose administration of LAS41008 120 mg     gastroresistant tablet and Fumaderm® 120 mg gastro-resistant tablet under fasting and fed     conditions. The study also aims to assess the safety of the study treatments.   "
25172|NCT02956187|"     Background. Functional dyspepsia is characterized by symptoms that apparently originate in     the stomach without detectable cause by conventional diagnosis test. The pathophysiology of     functional dyspepsia is not known, but a number of data indicate that dyspeptic patients have     increased sensitivity of the digestive system, so that physiological stimuli may induce their     symptoms. Some patients with functional dyspepsia have also functional constipation and the     investigators hypothesize that in them constipation triggers or facilitates dyspeptic     symptoms, and consequently, correction of constipation relieves dyspeptic symptoms.      Objective. To demonstrate the superiority of biofeedback versus a fiber supplement for the     treatment of dyspeptic symptoms in patients with constipation due to functional outlet     obstruction.      Design. Randomized, controlled parallel trial performed in a referral center. Participants.     Consecutive patients complaining of symptoms of functional dyspepsia and functional outlet     obstruction.      Interventions: Patients will be assigned to experimental (biofeedback for functional outlet     obstruction) and active comparator (fiber supplementation) arms. Biofeedback for functional     outlet obstruction: sessions of biofeedback guided by anorectal manometry (performed during     the first 3 weeks of the intervention period) combined with instructions for daily exercising     for 4 weeks. Fiber supplementation: 2.5 g plantago ovata per day for 4 weeks. Main outcome     and measures. Clinical symptoms of functional dyspepsia measured by daily questionnaires for     7 consecutive days before and during the last week of intervention.      Relevance. Functional Dyspepsia, defined by purely clinical criteria, brings together a     diverse group of conditions with different pathophysiology. As a result, the treatment is     empirical and globally inefficient. This study will identify a subset of patients with a     common pathophysiological mechanism of dyspeptic symptoms (functional outlet obstruction)     which respond to specific treatment (biofeedback).   "
25173|NCT02956174|"     Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided     Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth     in posterior regions.      Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM     Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were     needed and tooth preparations were standardized and performed by 2 expert prosthodontists.     CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were     cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1, 6,     12, 24, 36 and 48 months. The survival and success of the restorations were evaluated. The     technical and esthetic outcomes were examined using the United States Public Health Service     criteria. The biologic outcomes were analyzed at abutment and contralateral teeth and     descriptive statistics were performed.   "
25174|NCT02956161|"     This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates     the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.   "
25175|NCT02956148|"     The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in     HDGECs using the radioligand [18F]MNI-659. The study will be a follow-up, examining HDGECs     from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial     PET measurement.   "
25176|NCT02956135|"     The aim of this study is to assess the relationship between the presence of overuse injuries     and failure to control of movement in those areas. For this, participants will perform some     tests related to movement dysfunction lumbar-pelvic area to check for faults in one or more     movement planes.   "
25179|NCT02956096|"     Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood     pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that     transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in     healthy subjects, but little is known about these effects in stroke.      Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous     system modulation in patients post-stroke.   "
25180|NCT02956083|"     The primary goal of this investigation is to determine if lipid based artificial tear     supplementation has an impact on contact lens discomfort (CLD).   "
25181|NCT02956070|"     Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on     volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected     and recruited, following inclusion criteria and pre-established exclusion. All volunteers     will be guided and sign a term of clarification and consent. Volunteers will be randomly     divided into two groups: the control group to receive placebo capsules and application of     desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment)     and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone,     capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical     sessions with an interval of 7 days (one week) between them. The protocol for use of the     product is as follows: The volunteers in the experimental group will receive six capsules of     dexamethasone 8 mg each to be administered orally, initially two days before the first     bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first     clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice     session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of     whitening. After 7 days (one week), the same protocol will be held for the second and final     practice session office bleaching.   "
25182|NCT02956057|"     Study evaluates the efficacy and tolerability of low volume preparations compared with     conventional 4L polyethylene glycol prior to colonoscopy   "
25183|NCT02956044|"     The purpose of this study is to examine the drug-drug interaction in your body when given the     study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin,     glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how     well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.   "
25211|NCT02955680|"     Mother spend a large amount of time with their children. It is assumed that mother     contributes to their neurological development not only with visual stimuli, but also with     auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response     to the self-name being spoken by the mother than by a stranger. Therefore, investigators     suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten     the emergence from general anesthesia.   "
25218|NCT02955589|"     Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy     of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL)   "
25184|NCT02956031|"     Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still     undiagnosed and about 50% of diagnosed cases succumb per year. Although the current     prevalence of pre-cancer cervical disease is largely unknown, data from local studies suggest     regional differences and an increase in the prevalence of cytological abnormalities when     compared with historical data. Low frequency in cytology screening is the primary factor     attributable to development of invasive cervical cancer and almost one-third of all cervical     cancer patients had previous negative cytology. Due to the low sensitivity of cytology it can     be assumed that the true prevalence of pre-cancer disease is underestimated by all available     data. One round of optimal cervical cytology will detect around 50% of existing pre-cancer     cervical disease as identified and proven using colposcopy and directed biopsy. It is now     widely accepted that primary screening with a human papilloma virus (HPV) test can improve     the sensitivity of screening and that even a single round of HPV screening can rapidly reduce     the incidence of invasive cervical cancer and related mortality within a few years.      South Africa has a high prevalence of HIV infection and a delay in or failure to initiate     antiretroviral therapy (ART). These facts, together with the largely unscreened status of the     female population and the high incidence of cervical cancer all suggest that HPV infection     and precursors to cervical cancer are both unusually common among South African women.     Accurate current knowledge of the performance of newer generation HPV based screening tests     in HIV-infected and general female population are essential for cost-analysis and planning     for national prevention and screening programs. This study will aim to demonstrate the     feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based screening     assays in a South African setting.      The investigators hypothesize that HPV testing followed by normal and special cytology tests     will be a successful screening model for a South African population.   "
25185|NCT02956018|"     Kidney transplant thrombosis (loss of blood flow) is responsible for up to 35% transplant     failures in children. Detection of kidney transplant thrombosis currently relies on     recognition of deterioration in parameters such as urine output and blood creatinine levels,     which change relatively slowly. Confirmation is then required with an ultrasound scan. There     is inherent delay in the above process, during which time some or all of the transplant     kidney tissue can die, which can result in failure of the transplant.      Near infrared spectroscopy (NIRS) is a non-invasive technique used in continuous monitoring     of oxygen levels in several organ systems including the brain, muscles, gut, liver and native     kidneys. We hypothesise that NIRS can be applied to monitor kidney transplant blood flow in     real time.      We aim to test the use of NIRS in detecting blood flow in established kidney transplants in     children, and to compare it with ultrasound, the current gold standard measurement. Existing     NIRS equipment would be used within its CE marked purpose measuring oxygen levels; this     mechanistic study would extrapolate measured oxygen levels to determine blood flow.     Participating children attending outpatient clinic for routine transplant ultrasound scans     will have NIRs monitoring for a 10 minute period. NIRs data will be compared to a validated     perfusion score from ultrasound images.      If this study is successful, NIRS could provide continuous monitoring of kidney transplant     blood flow in the postoperative period, thus allowing immediate detection of blood flow     problems. This has potential to reduce kidney transplant failures from thrombosis.   "
25186|NCT02956005|"     The purpose of this study is to collect data prospectively on African American patients who     are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if     African American renal transplant recipients that receive Envarsus will have less tubular     injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR.      African americans have the higher rates of CYP3A5 which is associated with the need of higher     tacrolimus dose to achieve an adequate level and this many times is associated with signs and     symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies.      The retrospective cohort will be African American patients that will be matched by age,     gender, type of kidney transplant (living vs deceased) and level of sensitization   "
25187|NCT02955992|"     As ICU mortality is high, end-of-life is a subject of major concern for intensivists. With a     mortality rate of 20%, end-of-life care has become a daily responsibility. Among those     deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where     physicians, nurses and relatives must work together towards the most consensual decision. In     this context, patients' relatives feel vulnerable and, in the months that follow the death,     they are most likely to present symptoms that negatively affect their quality of life     (anxiety, depression, PTSD, prolonged grief). Many studies have shown that communication with     caregivers is one of the most highly valued aspects of care that impacts on family members'     experience during the patient's stay and after the patient's death. Improving communication     during the end-of-life process in the ICU context is a necessity that has been put forward in     palliative care and family-centered care guidelines.      This study aims to improve both communication skills and behaviour by giving precise     recommendations to physicians (3 step strategy) in their direct contact with patients'     relatives. We designed a 3-step physician-driven support strategy that consists in 3 meetings     with the relative - one before, one during and one after the patient's death. We hypothesize     that this strategy will improve communication in the end-of-life setting and thus should     reduce post-ICU burden for family members, specifically the development of prolonged grief 6     months after the death.   "
25188|NCT02955979|"     Iodinated contrast media are now frequently used in diagnostic imaging exams, including     pediatrics.      In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in     3-33% of exposed patients, especially as the patient is fragile, has comorbidities or     pre-existing renal aggression .      In children, the prevalence of this little known disease is probably underestimated.      The investigators intend to conduct a prospective epidemiological study, to estimate the     impact of the acute renale failure to iodinated contrast agents in pediatrics.   "
25189|NCT02955966|"     OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the     normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary     aspergillosis (IPA) could occur earlier than that of conventional imaging.      This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6.     The latter response will be correlated with the kinetics of selected biomarkers including     antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host     response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.   "
25190|NCT02955953|"     The study will aim to evaluate the following:        -  Whether there are any differences in the way the body handles LY2963016 U-200 and          LY2963016 U-100.        -  How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.        -  How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016          U-100.      The study will last up to 17 weeks for each participant, including initial screening and     follow up.   "
25219|NCT02955576|"     The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic     plaques.   "
25192|NCT02955927|"     This study aims to compare effects in retardation of myopia progression of combined ortho-k     and 0.01% atropine therapy with those of ortho-k alone.Myopia control methods mainly focus on     optical and pharmaceutical interventions . Currently, overnight-wear orthokeratology     (ortho-k), is used extensively in Hong Kong with approximately 50% retardation effect.     Pharmaceutical methods have focused on the use of atropine eye drops to slow myopic     progression.The use of 1% atropine was limited by the manifestation of side effects and     rebound effect.However, both side effect and rebound effect was minimal with 0.01%     atropine.It was suggested that 0.01% was the optimum concentration for controlling myopia.The     mechanisms of neither ortho-k nor atropine in myopia control are fully understood.It is     believed that ortho-k and atropine act via different mechanisms.It is possible that by     combining these two methods, additional retardation of myopia progression could be achieved.   "
25193|NCT02955914|"     Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous     research on this topic has focused on patient reported quality of life but has never examined     measurable clinical outcomes such as length of hospital stay.This pilot study hopes to     establish whether patient outlook (optimistic or pessimistic) before a heart operation can     influence recovery and length of hospital stay. If there is a difference, then a case can be     made for providing psychological support before an operation in the hope of modifying outlook     and thus improving patient care and reducing hospital stay and NHS costs. Patients will be     recruited over a 12month period. Their outlook (pessimistic or optimistic) will be     ascertained using two standardised questionnaires. Their recovery and length of stay will be     recorded. The study will answer the research question and determine whether outlook has an     impact on recovery. Depending on the results, this study could provide opportunities for     additional future research into modifying outlook with a view to improving patient care and     recovery.   "
25194|NCT02955901|"     Colonoscopy is one of the most common methods for the diagnosis and treatment of lower     gastrointestinal tract diseases and provides a unique opportunity to identify early     neoplastic lesions.      Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing     regimens, study of patient-related risk factors to fail a proper preparation and diet     adaptations have been studied recently.      A low residue diet is the standard in the day before the colonoscopy. Some endoscopists     prescribe this dietary plan for a 3-day period prior to the exam, although no study compared     the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation     results.      The aim of this project is to determine if the use of a 3-day low residue diet improves bowel     preparations results and the influence in patient tolerability and adherence.   "
25195|NCT02955888|"     This is a Phase 2, multi-center, double blind, placebo controlled study to evaluate the     safety and tolerability of PBI-4050, and its effects on the pancreatic, pulmonary functions     and on various biomarkers in Cystic Fibrosis patients with abnormal glucose tolerance.     Patients with abnormal glucose tolerance have elevated glucose level either at 1 hour or 2     hour during an Oral Glucose Tolerance Test (OGTT). The Main study will include 24 weeks of     treatment with PBI-4050 or matching placebo. At the end of the treatment period, patients     will have the option of participating in a 24-week Extension study.   "
25196|NCT02955875|"     The purpose of this study is to examine the effectiveness of pharmaceutical care service in     the management of poorly controlled type 2 diabetes mellitus.   "
25197|NCT02955862|"     CRICS financial report for the first budget year of the study   "
25198|NCT02955849|"     Aims and Objectives (Quantitative) Aim: To compare the effectiveness of selective laser     trabeculoplasty with trabeculoplasty in lowering the intraocular pressure in patients with     medically uncontrolled open angle glaucoma in rural China, taking into account the impact of     patient acceptance of each type of treatment      Hypothesis: Mean intraocular pressure after treatment with selective laser trabeculoplasty     will be lower than with surgery due to higher acceptance rates among patients randomized to     receive this treatment and therefore treatment provided at an earlier stage of disease     progression.   "
25199|NCT02955836|"     Objective: The purposes of this study are 1) to understand the nurses' need and perception     toward of the monitoring information system of nursing-related patient safety and quality     indicators; 2) to establish the monitoring information system of nursing-related patient     safety and quality indicators; 3) to evaluate the monitoring information system of     nursing-related patient safety and quality indicators.      Methods: There will be three phases and the study site in the medical center in northern     Taiwan. The first phase is information needs assessment. Researchers will hold the meeting of     focus group discussion. The subjects will be the nursing manager, head nurse, clinical nurses     who are similar to nursing-related patient safety and quality indicators. The self-conducted     semi-structure discussion form will be used to collect the data during the meeting of focus     group discussion. The questionnaire will be used to collect the perception, attitude,     behavior, satisfaction, time-consuming and the accuracy of nursing-related patient safety and     quality indicators data from nurses. The second phase will establish the monitoring     information system of nursing-related patient safety and quality indicators and clinical     implementation. The third phase will evaluate the effectiveness of the monitoring information     system of nursing-related patient safety and quality indicators. The questionnaire will be     used to collect the satisfaction, time-consuming and the accuracy of nursing-related patient     safety and quality indicators from nurses during the evaluation phase.   "
25200|NCT02955823|"     A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line     therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large     B-cells non-Hodgkin Lymphoma.   "
25212|NCT02955667|"     This study intends to carry out a prospective, randomized controlled trial to research and     development a new invivo microscopy based on the technology which is combined with     high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and     non-invasively by observing cervical tissues and cells, which makes it possible to diagnose     cervical cancer without wounds.   "
25213|NCT02955654|"     The purpose of this study is to determine whether acceptance and commitment therapy is     effective in the treatment of SSRIs-resistant obsessive- compulsive disorder.   "
25214|NCT02955641|"     The purpose of this study is to evaluate the efficacy and need for prescribing     anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.   "
25201|NCT02955810|"     This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with     newly diagnosed Multiple Myeloma (MM) will be treated with     Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) in combination with Daratumumab (DARA).      The safety profile of daratumumab to date, which does not appear to overlap with those known     for approved agents, combined with its distinct MoA, suggest that the therapeutic profile of     daratumumab combined with various backbone regimens may improve the treatment effect of these     regimens. Additionally, daratumumab as a single agent may prolong the progression free     interval for these patients. Based on the potential for cyclophosphamide to enhance ADCP,     there is a strong rationale to combine DARA with a cyclophosphamide, bortezomib containing     regimen. This will be the first clinical trial to explore the feasibility of combining     daratumumab with a cyclophosphamide containing backbone induction regimen and if successful     will provide the rationale for larger studies exploring the efficacy of this combination in     greater detail.   "
25202|NCT02955797|"     The purpose of the study is to evaluate the quadrivalent meningococcal conjugate vaccine when     used as a single-dose toddler vaccine in individuals who are either meningococcal vaccine     naïve or have received one or more doses of monovalent meningococcal C (MenC) vaccines during     infancy.      Primary Objectives:        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups          A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in toddlers          who either are meningococcal vaccine naïve or have received monovalent MenC vaccination          during infancy        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups          A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in          meningococcal vaccine naïve toddlers      Secondary Objectives:        -  To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal          serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as          measured by hSBA in toddlers who either are meningococcal vaccine naïve or have received          monovalent MenC vaccination during infancy        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W          after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in          meningococcal vaccine naïve toddlers        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W          after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers          who received monovalent MenC vaccination during infancy.      Observational Objective:        -  To evaluate the safety profile of MenACYW conjugate vaccine and Nimenrix®.   "
25224|NCT02955511|"     Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time     required to achieve successful tracheal intubation and improve the glottic view.      Study objective The purpose of this research study is to compare 3 different laryngoscope     blades (sizes: 3.5, 3.5 and 3) and see if the blades size 3.5 will reduce the time required     to achieve successful tracheal intubation and improve the physician's view of the glottis     compared to the standard direct laryngoscope using the blade size 3, in patients undergoing     lumbar surgery.      Primary end point: time to achieve successful tracheal intubation.      Secondary end points: glottic view at intubation, number of intubation attempts and     effectiveness of the integrated suction in the Inscope Direct Laryngoscope.   "
25300|NCT02954510|"     There are no current alternatives to diagnostic contrast-requiring imaging for patients with     an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to     nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury.     Ferumoxytol-enhanced imaging may offer an alternative approach.   "
25203|NCT02955784|"     The investigators are proposing a prospective one-arm cohort study testing the feasibility of     a game designed to improve symptoms in adults with mild levels of stress, depression, and     anxiety. The study will take place at Madigan Army Medical Center. Primary outcomes include     usage data including time, frequency and duration of app use, participant satisfaction with     the game, and comments and suggestions regarding participants' experiences using the     Sinasprite game over a 12-week period. Participants will download Litesprite's game,     Sinasprite, onto their personal smartphone. Elements of cognitive-behavioral therapies like     cognitive strategies, diaphragmatic breathing, and visualization are embedded in the game     enabling participants to learn to achieve the desired healthy habits. The game's goal is to     help Socks the Fox become a Zen Master. Over six weeks, players help Socks to progress by     describing and categorizing their concerns, entrusting Socks to hold these concerns, and     engaging in bonding activities with Socks, such as fishing and meditation. The investigators     currently have a prototype and have been told by insurance firms, providers, and self-funded     employers that they need to see validated results from a pilot study that shows feasibility     with subjects in the target audience before they can consider a commercial roll out.     Participants will complete questions related to mood, stress, and well-being at baseline, 6     weeks, and 12 weeks. Data will be evaluated in real-time and reports of participant progress     will be provided to the participant's provider, with the participant's consent. Data and     feedback from this pilot study will be used to update the design and inform the technical     development team to further refine the game experience in preparation for a larger randomized     controlled trial evaluating the effectiveness of Sinasprite.   "
25204|NCT02955771|"     This is a multi-center, randomized, controlled, open-label, phase IIa clinical study.The     study will observe the efficacy and safety of Deuteporfin photodynamic therapy in addition to     stenting compared to stenting alone in patients with unresectable advanced Perihilar     Cholangiocarcinoma.   "
25205|NCT02955758|"     This phase II trial studies how well pembrolizumab works in treating patients with     non-squamous non-small cell lung cancer which has spread to other places in the body.     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells     to grow and spread.   "
25206|NCT02955745|"     Current iodine requirements defined for pregnancy and lactation are rough factorial estimates     extrapolated from older studies in adults that used radioactive iodine tracers. To ensure     optimal thyroid function in these vulnerable groups, a tracer method that could be safely     used to accurately define iodine requirements would be valuable. Iodine-129 (129I), a     long-lived semi-stable isotope with no health risks, could be used as a tracer, but the     analytic challenges are formidable. However, we have developed an ICP-MS method to measure     pp-billion (10-9) to pp-trillion (10-12) quantities of 129I in biological samples. In this     project we will perform a study in which iodine-replete adult subjects will consume an oral     dose of 129I. We will quantify 129I kinetic patterns in plasma, urine and stools after the     oral dose, and use these data to derive tracer absorption, retention and excretion rates.     This trial will allow us to define optimized procedures for the routine application of this     method to assess iodine metabolism in humans. The use of 129I may prove to be a breakthrough     technique to safely assess iodine metabolism and requirements in pregnant/lactating women in     order to ensure healthy thyroid function in these age groups.   "
25207|NCT02955732|"     We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after     intranasal dosing employing pharmacometric methods in otherwise healthy 1 month to 11 years     of age children scheduled for minor surgery or other procedures requiring sedation or     anesthesia.   "
25208|NCT02955719|"     Age remains the single most significant risk factor for developing dementia, particularly     Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest to     determine modifiable risk factors, whether by prevention, earlier detection, or an ability to     slow the rate of decline, is a key priority in health care. Primary care is likely to play a     pivotal role in this initiative. Collaborative mental health care between primary care     providers and mental health clinicians has been demonstrated to be effective at the patient     and system levels. Thus, the overall goal of this project is to assess impact and feasibility     of implementing a collaborative care evidence-based Integrated Care Pathway (ICP) in     addressing three potentially reversible risk factors at high risk for developing AD: anxiety,     depression, or mild cognitive impairment (MCI).   "
25220|NCT02955563|"     The goal is to develop a pragmatic, scalable intervention to overcome problems with surrogate     decision making in ICUs.      The aim is to conduct a pilot study among 100 surrogates and clinicians of incapacitated     patients at high risk of death to assess the impact of the CSDM (communication and shared     decision making) web-based tool on key elements of decision making quality.   "
25221|NCT02955550|"     This study will find the highest acceptable treatment dose and timing of infusion of cord     blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with     multiple myeloma.      The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is     administered after treatment to help the NK cells expand in the body. The safety of this     treatment will be studied and researchers want to learn if NK cells will help in treating     multiple myeloma.   "
25222|NCT02955537|"     This study seeks to evaluate a multicomponent mobile intervention to change multiple     hypertension-related health behaviors in African Americans with uncontrolled hypertension.     Half of the participants will receive a mobile intervention designed to improve physical     activity, sodium intake, and medication adherence. The other half will receive usual care.   "
25223|NCT02955524|"     The objective of this study is to use local topical anesthesia to numb the sensory input,     captured by branches of the Trigeminal nerve found on the skin in and around the eye, to     decrease a hemodynamic reflex seen during placement of a catheter for intra-arterial     chemotherapy (IAC) for eye tumors in children. This Trigeminal-cardiac reflex brings about     hemodynamic instability during general anesthesia.      Normally, one could block this sensorial input with ophthalmic peribulbar placement of local     anesthetics, but these eyes have malignant growth and invasive procedures may cause more     harm. The investigators are aiming to numb the sensory branches of the trigeminal nerve     non-invasively and observe for any decrease in these events.   "
25225|NCT02955498|"     The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and     S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination     formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a     combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults.     Additionally the safety and tolerability of two drugs will be evaluated.   "
25319|NCT02954263|"     Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of TD-1439 in healthy adult and elderly subjects   "
25226|NCT02955485|"     Chronic ankle instability is a common problem that may follow an ankle sprain. Until a     patient has developed chronic ankle instability they are ineligible for surgical treatment     although early surgical treatment yields better results compared to surgical treatment of     subjects that have experienced recurrent ankle sprains. However, treating all patients with     an ankle sprain surgically is not an option due to the high amount of unnecessary invasive     interventions.      The objective of this study is to identify which patients will develop chronic ankle     instability and to develop a model to predict which patients should receive early surgical     treatment.      In this prospective observational cohort all patients (older than 18 years) that report at     the emergency department of the participating hospitals after a lateral ankle sprain, of whom     an x-ray is made after positive Ottawa Ankle Rules and on which there is no visible fracture     or other pathology.      The main study parameter is a significant difference in patient characteristics, foot and     ankle configuration and joint pathology between patients who develop chronic ankle     instability and patients who do not experience recurrent ankle sprains and restriction during     daily live after an initial sprain.   "
25227|NCT02955472|"     The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR     GLARS-NF3 tablet 150mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 150mg     administered regular diet and (2) determine the safety and tolerability of a single dose of     GLA5PR GLARS-NF3 tablet 150mg administered regular diet and GLA5PR GLARS-NF1 tablet 150mg     administered regular diet.   "
25228|NCT02955459|"     This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and     pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion     in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2     subjects will receive VNRX-5133 for 7 days.   "
25229|NCT02955446|"     This is a single-center, open label, non randomized, compassionate use protocol in patients     with advanced solid tumor malignancies who were previously enrolled in the phase I study     (NCT00878189) of this agent.   "
25230|NCT02955433|"     This study is a prospective clinical trial designed to primarily test the impact of     rideshare-based transportation services from a digital transportation network, Lyft, on     reducing primary care clinic missed appointments--a composite outcome of no-shows and same     day cancellations--for Medicaid patients. The study population consists of West Philadelphia     residents who are established patients at two of the Penn Medicine Primary Care Practices     within the University of Pennsylvania Health System. The study subjects are allocated into     the intervention or control arm using a pseudorandomization approach - those receiving an     appointment reminder on an even calendar day are in the intervention arm and odd calendar day     calls are in the control arm.      Secondary outcomes include the time of arrival to the clinics relative to actual appointment     time (both arms), prospective utilization of acute care settings (both arms), prospective     utilization of primary care (both arms), and description of programmatic metrics in the     intervention arm (travel time, misuse, and costs). The investigators will assess the patient     experience after each ride using a telephone-based survey and in-depth interviews. All adults     with established primary care at the Penn Medicine Clinics, who have Medicaid, and do not     require wheelchair accessible rides will be eligible for the rideshare service. The     investigators hypothesize that individuals offered a rideshare-based transportation service     will have a decreased proportion of missed appointments and same day cancellations as those     not offered the service.   "
25231|NCT02955420|"     Berlin Cures develops BC 007 to treat patients suffering from diseases (chronic heart     failure, pulmonary hypertension, chronic fatigue syndrome etc.) which are associated with     functional autoantibodies (AAB) directed against G-protein coupled receptors (GPCR).      The first part of the study (part A) is designed to evaluate the safety and tolerability of     ascending doses of BC 007. The study part is blinded and placebo controlled in order to     better discriminate possible safety signals. The assessment of safety and tolerability in an     elderly cohort is a bridge to dosing elderly GPCR AAB positive subjects in part B. The     subjects in part A are confirmed to be GPCR AAB negative.      The objective of the second part of the study (part B) is to evaluate the efficacy of BC 007     in neutralizing AAB against GPCR shortly after dosing compared to baseline and to find the     optimal dose for the neutralization of the AAB in all individuals. This dose shall be taken     to progress into a Phase II/III trial with beta1-adrenergic receptor-AAB positive patients     suffering from chronic heart failure.   "
25232|NCT02955407|"     Patients with inflammatory back pain were shown to differ from healthy controls in genotype     of the Angiotensin-converting enzyme (ACE), which regulates vasoconstriction/-dilatation. The     aim of this study is to investigate whether genetic reduction of muscle perfusion might be a     pathophysiological pathway of how genes influence chronic non-specific low back pain (LBP).   "
25233|NCT02955394|"     This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant     plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced     AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.   "
25234|NCT02955381|"     Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55     years old of all skin types will be asked to sign an informed consent form prior to any study     procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on     the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in     each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will     be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline     (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit     visit). The treatment area will be evaluated at each visit by the unblinded investigator     regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness,     smoothness, and clarity. Safety and adverse events will be captured at each visit only by the     unblinded investigator.   "
25235|NCT02955368|"     The purpose of this study is to determine superiority of DP-R212 comparing to each     monotherapy in patient with hypertension and primary hypercholesterolemia.   "
25290|NCT02954640|"     In order to accelerate the identification of genes responsibles of PID, and to improve the     diagnosis of PID, the research team would like to validate a rapid and targeted method of     high-throughput sequencing, on 301 genes, known to be involved in PID.   "
25236|NCT02955355|"     The purpose of this study is to assess the long-term safety, tolerability, and immunogenicity     of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous (IGSC) facilitated with     recombinant human hyaluronidase (rHuPH20) (HYQVIA/HyQvia) in participants with chronic     inflammatory demyelinating polyradiculoneuropathy (CIDP) who have completed Baxalta Clinical     Study Protocol 161403 Epoch 1 or Clinical Study Protocol 161601 without CIDP worsening.   "
25237|NCT02955342|"     To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and     neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.   "
25238|NCT02955329|"     This study will investigate the delivery, systemic exposure, subjective and physiologic     effects of THC vaped from e-cigarettes.   "
25239|NCT02955316|"     The primary objective of this study is to estimate the overall prevalence of IBS medically     diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.   "
25240|NCT02955303|"     This study assess the feasibility of novel cognitive intervention utilizing tablet apps (TECH     protocol: Tablet Enhancement of Cognition and Health) in terms of relevance, adherence,     suitable challenges, training time etc. for healthy older adults. Sixty two older adults with     normal cognition will be randomly allocated to the TECH protocol (experimental group) or the     control group (no treatment). Assessments will be administered pre and post the 6-week TECH     protocol by assessors blind to group allocation.   "
25241|NCT02955290|"     This partially randomized phase I/II trial studies the best dose and side effects of     recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax) and nivolumab and to see how     well they work in treating patients with stage III-IV non-small cell lung cancer. Vaccine     therapy, such as CIMAvax vaccine may help slow down and stop tumor growth. Monoclonal     antibodies, such as nivolumab, may block a protein needed by tumor cells to grow and spread.     Giving CIMAvax vaccine together with nivolumab may work better in treating patients with     stage IIIB-IV non-small cell lung cancer.   "
25242|NCT02955277|"     This study assess the effectiveness of novel cognitive intervention utilizing tablet apps     (TECH protocol: Tablet Enhancement of Cognition and Health) to improve cognitive abilities,     daily function and health-related quality of life of older adults with MCI. Forty six older     adults with MCI will be randomly allocated to the TECH protocol (experimental group) or     standard care (control group). Assessments will be administered pre and post the 6-week TECH     protocol and at 6-month follow-up by assessors blind to group allocation.   "
25243|NCT02955264|"     The goal of this study is to better characterize the metabolic alterations and sugar     structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital     Disorders of Glycosylation. The investigators aim to assess the safety and tolerability of     oral galactose treatment in a small pilot group of Congenital Disorders of Glycosylation     patients. The investigators will also determine the relationship between simple milk sugar     intake (galactose dose) in the diet and the blood and urine markers of protein glycosylation     abnormalities.   "
25244|NCT02955251|"     This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2     dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)     profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in     participants with advanced solid tumors.   "
25313|NCT02954341|"     The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF     System in patients with Class III Heart Failure in a commercial setting.   "
25417|NCT02952976|"     This study is being done to compare two different Temporary Abdominal Closure methods that     could be used in cases like yours. The methods being compared are the Barker's vacuum packing     technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera).   "
25245|NCT02955238|"     The Latino population in the United States is increasing in size; is diverse in culture,     backgrounds and countries of origin; is experiencing unique influences from social and     behavioral acculturation to the U.S.; is reported nationally to have lower rates of heart     disease; is reported to have increased prevalence of diabetes and asthma; and is generally     poorer and less educated (NHLBI working Group, 2003). They represent an important target     population for disparities research. In particular Latinos accessing care in Community Health     Centers in the United States represent an ideal population for conducting disparities     research because lack of access to care is minimized through various governmental health     insurance support mechanisms. This study will build on existing relationships to conduct the     proposed study, using expertise in epidemiologic, behavioral and genetic research in an     effort to promote a coordinated, comprehensive, interdisciplinary and focused research effort     to improve the care being delivered to indigent Latinos at-risk for and with CVD.   "
25246|NCT02955225|"     The purpose of this study is to determine whether use of a pressure-detecting shoe improve     can enhance favorable loading conditions at the knee.   "
25247|NCT02955212|"     This is a Phase 3 multicenter study that includes two periods. Period 1 is a 12-week,     randomized, double-blind, parallel-group, placebo-controlled period designed to compare the     safety and efficacy of ABT-494 versus placebo for the treatment of signs and symptoms of     participants with moderately to severely active RA who are on a stable dose of csDMARDs and     have an inadequate response to csDMARDs. Period 2 is a blinded 52 week extension period to     evaluate the long-term safety, tolerability, and efficacy of ABT-494 in participants with RA     who have completed Period 1.   "
25248|NCT02955199|"     This is a Stage III community-based randomized clinical efficacy trial testing Mothering from     the Inside Out (MIO), the first evidence-based parenting intervention designed to be     delivered by addiction counselors in addiction treatment settings where parents of young     children are enrolled in treatment.   "
25249|NCT02955186|"     The purpose of this study is to evaluate the effects of the study medication,     saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory     setting in which participants are given an initial drink of alcohol followed by the choice to     drink up to 12 more drinks over a three-hour period. The investigators hypothesize that     saracatinib will reduce craving and number of drinks consumed prior to and after exposure to     the initial drink of alcohol and during the three hour drinking period.   "
25333|NCT02954081|"     Patient treatment preference and treatment satisfaction of physicians and patients comparing     fumaric acid ester therapy with subsequent apremilast treatment   "
25250|NCT02955173|"     The primary purpose of this study is to compare both short-term and long-term treatment     effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on     circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out     principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary     purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric     and rectal cancer treatment using CTC as a biomarker.   "
25251|NCT02955160|"     This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm     parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal     vaccination will be randomized equally to receive either a single intramuscular dose of     multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular     pertussis combination vaccine (Tdap) (control group).   "
25252|NCT02955147|"     The purpose of this study is to determine whether ustekinumab is effective in the treatment     of Giant Cell Arteritis (GCA)   "
25253|NCT02955134|"     The purpose of this study is to evaluate long-term efficacy of Chinese medicine treatment for     chronic atrophic gastritis. It is a multi-center, randomized, placebo-controlled trial.   "
25254|NCT02955121|"     Randomized controlled study to examine physician use of pharmacogenetic information in     patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).   "
25255|NCT02955108|"     The objective of this study is to look at the effects of distractive auditory stimuli (DAS)     on reducing dyspnea intensity and related anxiety and increasing exercise tolerance.     Investigators hope that compared to a no-music control condition, that under a music     condition participants with COPD will (a) demonstrate increased self-paced walk distance and     enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have     less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a     tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive     and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The     long-term goal of this study is to increase physical activity in adults with COPD and RLD by     promoting dyspnea and fatigue management through use of distractive auditory stimuli in the     form of music.   "
25256|NCT02955095|"     The purpose of the usability and pilot testing for the project Developing a Bi-national     Buddy Intervention for Smoking Cessation and Cultural Education is to better understand how     users interact with the smoking cessation app, and to improve the product based on the     results. In pilot testing the smoking cessation app the investigators will examine the     feasibility of our approach. The usability testing portion of the study is intended primarily     to improve on the design of the smoking cessation app, and will: gather quantitative data on     participant's performance, identify usability problems, and determine user satisfaction with     the app. The pilot testing portion of the study will evaluate the feasibility, time, cost and     statistical variability in an attempt to predict an appropriate sample size and improve upon     the study design prior to performance of a full-scale research study.      Objective 1:To collect quantitative data on participant's performance while using the app for     smoking cessation.      Objective 2:To identify problems with usability of the smoking cessation buddy app.      Objective 3:To assess user satisfaction with the smoking cessation buddy app. Objective 4:To     improve upon the design of the smoking cessation buddy app Objective 5:To assess the     feasibility, time, cost, and statistical variability for a full-scale implementation of this     study with the intervention group.   "
25324|NCT02954198|"     With the availability of well-studied once-daily formulations of tacrolimus, the ability to     achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may     finally be achievable and have the potential to optimize immunosuppression safety and     efficacy in kidney transplantation.   "
25418|NCT02952963|"     The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants     on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.   "
25257|NCT02955082|"     Prostate cancer (PrCa) is one of the commonest cancer in men in the Western world, with over     40,000 new cases diagnosed each year in the United Kingdom (UK). Research studies have     identified several genetic changes that are thought to increase the risk of developing     prostate cancer. Some of these genetic changes occur in deoxyribonucleic acid (DNA) repair     genes. The BARCODE 2 study is formed of two parts that aim to investigate how having genetic     changes in DNA repair genes can affect response to treatment. In part 1 of the study, the     investigators will invite men with metastatic castration resistant prostate cancer (mCRPC)     who have not had genetic testing before to join the study by initially undergoing genetic     screening within the study. If a pathogenic mutation is confirmed in one of these genes,     patients will be given the option to proceed to part 2 of the study. In part 2 of the study,     men with mCRPC who are known to be carriers of a mutation in DNA repair gene(s) will be     assessed for eligibility for treatment on the study. The aim of the study will be to     determine how patients with mCRPC and a germline mutation in a DNA repair gene(s) respond to     platinum chemotherapy. This study will help researchers to investigate the platinum     sensitivity of prostate tumours that have developed due to a germline mutation in a DNA     repair gene. This study will provide data to use in a larger clinical trial of platinum     chemotherapy based on patients' germline genetic signature and/or tumour genetic profile.   "
25258|NCT02955069|"     This is a study to investigate the efficacy and safety of PDR001 in patients with advanced or     metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic,     gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic     neuroendocrine carcinoma (GEP-NEC) that have progressed on prior treatment.   "
25259|NCT02955056|"     This is a single site feasibility trial to test whether daily administration of Teriparatide,     in participants with Weber type B ankle fractures that are being conservatively managed, is     superior to the standard care treatment with regard to the rate of healing.   "
25334|NCT02954068|"     This double-blind, randomized controlled trial will evaluate the effect of the route of     administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will     be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection     IM   "
28980|NCT02906319|"     The purpose of this study is to determine the association between serum 25-hydroxyvitamin D     and HbA1c levels in diabetic patients with chronic kidney disease. The investigators     hypothesized that serum 25-hydroxyvitamin D levels were negatively correlated with HbA1c     levels.   "
25260|NCT02955043|"     The goal of this project is to conduct a pilot randomized clinical trial (RCT) to evaluate     the feasibility of a brief, behavioral intervention to improve recovery following     hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT     will learn behavioral techniques to improve sleep and increase daytime activity with the goal     of alleviating insomnia, fatigue, and depression. If the intervention demonstrates evidence     of feasibility and acceptability, a future study will test the effects in a larger trial,     with the long-term goal of improving the care and quality of life of cancer survivors     recovering from HSCT.   "
25261|NCT02955030|"     The purpose of this study is to evaluate the safety and immunogenicity of a sublingual     administration of NSV0001 in healthy male volunteers.   "
25262|NCT02955017|"     The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass     index decrease at 15 months compared to traditional management in obese adolescents.   "
25263|NCT02955004|"     The purpose of this study is to study the effects of transthoracic electrical cardioversion     for restoration of sinus rhythm in patients who present with recent onset atrial     fibrillation, with regard to new silent cerebral thrombo-embolic lesions and cognitive     function, as well as electrical and functional/structural reverse remodelling, and its     effects on inflammatory changes / specific cardiac biomarkers, vasoactive peptides,     coagulation activity, and active fibrinolysis.   "
25264|NCT02954991|"     The study will evaluate the clinical activity of nivolumab in combination with 3 separate     investigational agents, glesatinib, sitravatinib, or mocetinostat.   "
25265|NCT02954978|"     Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor     and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the     substantia nigra (SN) pars compacta and formation of inclusions known as Lewy bodies (LBs)     that primarily contain aggregated alpha-Synuclein. Nilotinib (Tasigna®, AMN107, Novartis,     Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated for     CML treatment at oral doses of 600-800mg daily. Nilotinib penetrates the brain and promotes     autophagic degradation of alpha-Synuclein and p-Tau, leading to survival of DA neurons and     improvement of motor function in PD models. For these studies, Nilotinib (1-10mg/kg daily)     was used at significantly less than the clinically approved dose (up to 1200mg daily) in CML.   "
25266|NCT02954965|"     The purpose of the current study is to test the efficacy of two brief, behavioral     interventions intended to improve burnout among doctoral-level graduate students (n = 102).     Specifically, individuals will be randomly assigned to one of three intervention conditions:     1) Reward: a brief intervention to help participants increase engagement in healthy and     rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants     identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control     condition that involves monitoring only. Multilevel modeling will be used to assess changes     in burnout, mood, and stress, following the interventions, controlling for participants'     individual baseline levels of these variables.   "
25267|NCT02954939|"     This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on     lymphocyte subsets in patients with proliferative lupus nephritis. Patients with     biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day)     plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d)     maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF     (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum     cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction     treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the     two treatment regimens, and also correlated with subsequent risk of relapse.   "
25268|NCT02954926|"     Majority of healthcare authorities believe that due to the methodological weakness and small     number of patients in conducted therapeutic trials, the evidences are insufficient to support     the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis.     The objective of this research is to determine the effect of intravenous immunoglobulin in     prevention of preterm neonatal sepsis.   "
25358|NCT02953743|"     The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic     (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular Carcinoma     (HCC).   "
25359|NCT02953730|"     The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human     Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents   "
25269|NCT02954913|"     Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary     colorectal tumour and liver metastases within 12 months, is a common problem faced by     colorectal and hepatobiliary surgeons.(Adam) The traditional approach is to perform staged     resections unless the liver resection required is limited (i.e. small wedges of peripheral     lesions). The downside of performing staged vs. simultaneous resections is that patients must     undergo two major operations instead of one, which limits a patient's ability to return to     their pre-surgical state of health in a timely fashion, increasing health care costs (Ejaz)     and delaying the start of adjuvant chemotherapy. The disadvantages of a simultaneous approach     include longer operating room times potentially increasing the major postoperative     complication rate including blood transfusions, surgical site infections, anastomotic leaks     and post-hepatectomy liver failure. Recent data from tertiary cancer centres suggest that     simultaneous resection of the colon and rectum along with liver resection of any magnitude is     feasible and safe.(Silberhumer) Although encouraging, this data comes from specific patients     from a highly selected institution, results that are perhaps not generalizable.      This proposal is a feasibility study consisting of a pilot single arm prospective study at     two different large-volume Hepatobiliary Centres of patients with synchronous colorectal     cancer with liver metastases undergoing simultaneous resection of the colon or rectum and     liver to evaluate their complication rates (including the calculation of the comprehensive     complication index), quality of life, cost evaluation, and proportion of eligible patients     recruited over a 12-month period. The results of this pilot study will provide us with the     information necessary to build a large multicentre randomized controlled trial comparing     staged vs. simultaneous resection for synchronous colorectal cancer liver metastases.   "
25270|NCT02954900|"     The purpose of this pilot study is to evaluate a decision support website (RealRisks)     designed to inform patients about breast cancer chemoprevention. It is coupled with a     physician-centered (BNAV) decision support website as part of clinical workflow in the     primary care setting. The investigator hypothesizes that improving accuracy of breast cancer     risk perception and understanding of the risks/benefits of chemoprevention will enhance     informed decision-making and uptake of breast cancer prevention strategies in the primary     care setting.   "
25271|NCT02954887|"     This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,     and an open-label extension phase. The open-label extension phase only will be described in     this record. All participants will receive GWP42003-P.   "
25273|NCT02954861|"     'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of     the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During     their recovery period, a significant number of patients experience delirium, a clinical     syndrome of acute onset and fluctuant course.Though these deficits are often known to be     transient without any permanent physical or neurological impairment, the experience can still     psycho-socially affect these patients for a longer length of time even after discharge. The     presence of delirium puts excessive, undesired strain on the patient, their families, health     care providers and hospital resources.      PTSS is an anxiety disorder caused by very stressful, frightening or distressing events. It     is known to either develop immediately after the disturbing event or weeks and months later.     The actual symptoms can be varied but are categorized in three sections: i.e.:     re-experiencing, avoidance and emotional numbing and hyperarousal (feeling 'on edge').      A problem that has such an impact on any patient is worth investigating and understood     better. Being in such a unique professional position, as a Clinical nurse practitioner, the     investigator is ideally placed to conduct this study. In this study, the researcher will be     focusing on the pre-operative risk factors in developing delirium, actual incidence of     delirium and follow the patients post operatively to evaluate the after effects of delirium     in the form of PTSS.   "
25274|NCT02954848|"     The purpose of this study is to evaluate the efficacy and safety of oral TAK-438 10 mg     once-daily in the treatment of non-erosive gastroesophageal reflux disease   "
25275|NCT02954835|"     The purpose of this study is to compare wound infection rates between negative pressure     therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular     surgery involving groin incisions.   "
25276|NCT02954822|"     A randomized, open-label, multiple dosing, three treatment, three period, two sequence     clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of     evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects   "
25277|NCT02954809|"     The purpose of this study is to determine the effects of morning bright light therapy on     fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.   "
25278|NCT02954796|"     This study tests the safety of a drug called SGN-CD352A, to find out what its side effects     are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple     myeloma.   "
25279|NCT02954783|"     Background and purpose: The purpose of this study is to investigate the effect of exercise on     intratumoral natural killer (NK)-cell variability in patients with localized prostate cancer     undergoing radical prostatectomy.      The primary hypothesis is that exercise induces epinephrine-mediated intratumoral natural     killer (NK)-cell infiltration in patients with localized prostate cancer, and that the     infiltration is greater in patients performing High Intensity Interval Training compared to     moderate intensity training.      Currently there is a lack of randomized controlled trials examining different types of     exercise in patients with localized prostate cancer. Moreover there is a need for studies     including biological measurements to allow a full assessment of the effect of exercise on     diverse biomarkers and mechanistic pathways, which may influence cancer survival.      Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical     prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.      Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer     undergoing radical prostatectomy will be included and randomized to either High Intensity     Interval Training (HIIT) exercise intervention, Moderate-Intensity Aerobic Exercise and     Resistance Training (MI-AT+RT) intervention (standard recommendations) or observational     control receiving usual care for a total period of 8 weeks.      All patients will undergo assessments at inclusion (baseline) and after 8 weeks (5-7 days     prior to surgery,) respectively.      Assessments include: anthropometrics; blood pressure; resting hearth rate; cardiorespiratory     fitness by cardiopulmonary exercise test (VO2 peak.); body composition by DXA scan; quality     of life by self-report questionnaires; oral glucose tolerance test; fasting blood sample     measuring cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose, hormones and     inflammatory markers.      Also, the investigators will collect blood samples before, during and after an acute exercise     bout in order to explore the acute systemic changes in exercise-regulated biomarkers.      Biological tissue from tumor (primary prostate biopsies) will be retrieved from the     respective local pathological departments and from the perioperative prostate specimen and     sent to protocol analyses.   "
25280|NCT02954770|"     This is a one year follow up survey study after a Fitbit® challenge study to determine if     wearing a Fitbit® motivates residents to increase their physical activity. This study seeks     to determine if residents continue to use the Fitbit® after one year.   "
25392|NCT02953301|"     The purpose of this study is to determine whether resminostat will be able to delay or     prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary     Syndrome that have recently achieved disease control with previous systemic therapy.   "
25281|NCT02954757|"     Uterine adenomyosis is a common uterine benign condition. They can cause abnormal menstrual     bleeding, and menstrual pain. Although surgical intervention is the definitive treatment,     some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU)     therapy is receiving increasing interest in the management of uterine adenomyosis by inducing     focal thermocoagulation of the fibroids. Results obtained by various research groups have     shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main     objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of     uterine adenomyosis.      In this proposed study, 10 patients who have symptomatic uterine adenomyosis who meet the     study inclusion criteria will be invited to participate in the study which involves the use     of HIFU in the management of the adenomyosis. Background information of the patients such as     age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic     medical disease will be collected. Subjects will also be asked to complete an eight-item     section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) and     menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of     women.   "
25291|NCT02954627|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In     the parent trial, patients will be subjected to an 8-week diet intervention phase including a     low-calorie diet and dietetic counseling, after which patients will be randomised to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.      This substudy aims to investigate any changes in the carotid intima media thickness (CIMT)     assessed by ultrasound in relation to an initial 8-week weight loss intervention.   "
25335|NCT02954055|"     This is a multi-center, randomized phase II trial that will randomise women with ER-positive,     HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally     relapsed breast cancer in a ratio of 1:1 to receive a metronomic regimen of vinorelbine plus     cyclophosphamide and capecitabine, or the conventional paclitaxel monotherapy.   "
25282|NCT02954744|"     Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual     bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the     definitive treatment, some women prefer to have their uterus preserved. High-intensity     focused ultrasound (HIFU) therapy is receiving increasing interest in the management of     uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by     various research groups have shown that HIFU treatment is safe, effective and is highly     acceptable to patients. The main objective of this study is to evaluate the therapeutic     efficacy of HIFU in the treatment of uterine fibroids.      In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study     inclusion criteria will be invited to participate in the study which involves the use of HIFU     in the management of the fibroid. Background information of the patients such as age, body     mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical     disease will be collected. Subjects will also be asked to complete an eight-item section of a     Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect     of the fibroid on the quality of life of women.   "
25283|NCT02954731|"     Transdiagnostic Cognitive Behavior Therapy (CBT) delivered in the individual format, have     been proven just as effective as traditional diagnosis specific CBT manuals. The     investigators have translated and modified the The Unified Protocol for Transdiagnostic     Treatment of Emotional Disorders (UP-CBT) to make it applicable as group therapy in Danish     Mental Health Service and a naturalistic trial of this manual has shown promising results. As     the use of one manual instead of several diagnosis specific manuals in regional clinics could     simplify logistics and reduce waiting time, the investigators want to compare group UP-CBT     with diagnosis specific group CBT.      Method: A partial blinded, pragmatic, non-inferiority, multicentre randomized clinical trial     (RCT). UP-CBT is compared to treatment-as-usual CT. 124 patients are included in each     intervention arm, recruited from three Danish regional Mental Health Service Clinics.   "
25284|NCT02954718|"     Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood.     The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain,     stiffness and limitations on daily living activities (DLA) in varying degrees. However, the     information about prevalence of symptoms, disorders, DLA limitations, participation     restriction and options of treatments for upper extremity involvement in JIA are limited. It     has been reported that improvements of upper extremity functions were achieved by video-based     games (VBG) in various disease groups. However, in the literature, no study has been found     about effectiveness of WBG in children with arthritis. The aim of the study was to     investigate effects of task-oriented activity training (TOAT) with VBG versus activity     training in real life on activity performance and participation in children with arthritis.     Participants with upper limb involvement in JIA were randomly assigned to the activity     training in real life group (group I) and TOAT with VBG in real life group (group II). The     actual materials and rehabilitation kits will be used for activity training in group 1, the     DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity     muscle strength and grip, range of motion, upper limb functions, activity, participation and     quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG     improves the activity performance and physical functions and increases the participation, via     being stimulative and interactive in order to provide feedback and to increase interest and     motivation.   "
25285|NCT02954705|"     Activation of neutrophils by ANCA (Anti-Neutrophil Cytoplasm Antibodies) and subsequent     microvascular endothelial cell damage is the main feature of ANCA-associated vasculitis     (AAV), a severe autoimmune disease that often targets the kidney. There is no specific     treatment for AAV to date and 25% of patients with renal damage evolve towards end-stage     renal disease, requiring dialysis and kidney transplantation. In addition, there is no     reliable biological marker of the disease activity available, which makes the diagnostic,     follow-up and treatment of patients difficult. Therefore, the identification of new     therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to     improve AAV patients care and to ameliorate their renal outcome.   "
25286|NCT02954692|"     Primary Objective:      To assess the mean change in HbA1c (glycated haemoglobin).      Secondary Objectives:      To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:        -  Targeted HbA1c;        -  Targeted fasting self- monitoring blood glucose (SMBG);        -  Hypoglycemic events;        -  Adverse events;        -  Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire          status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);        -  Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in          subgroup patients.   "
25287|NCT02954679|"     This descriptive and declarative study will help to find out consumption rates, all     psychoactive substances taken together, among 18-25 year olds. More specifically, it will     allow assessment of the extent of the cognitive enhancement phenomenon among students in     France (including study of misuse of methylphenidate (MPH) and modafinil in improvement of     cognitive performance).   "
25393|NCT02953288|"     To investigate the genetic mutations of patients with thyroid carcinoma and find molecular     targets for therapy.   "
25288|NCT02954666|"     Different approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus     node dysfunction, and functional atrioventricular block have been published. Investigators     have developed a more limited and specific approach of CNA, called cardio-neuromodulation     (CardNM). This treatment is based on a tailored vagolysis of the sinoatrial node through     partial ablation of the anterior right ganglionated plexus (ARGP); it is also based on an     innovative anatomic strategy. The feasibility of CardNM has already been tested in our center     in a limited first study in humans (CardNMH1), with a favorable outcome for the patients     involved. The results of CardNMH1 have been submitted for publication. The purpose of this     second study of CardNM in humans (CardNMH2) is to collect more procedural and clinical data     in well-defined patient groups.   "
25289|NCT02954653|"     Two part, dose escalation and dose expansion study. Open label, multi center, non randomized,     multiple dose, safety, pharmacokinetic and pharmacodynamic study of single agent PF-06747143     in sequential dose levels of adult patients with refractory or relapsed AML in order to     establish maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) or maximally     permitted dose (MPD) following by a 3 arm dose expansion with PF-06747143 in combination with     standard of care chemotherapy in adult patients with AML.   "
25292|NCT02954614|"     Background: Physical activity (PA) is a key component in health promotion and prevention of     overweight. Interventions delivered in after-school programs (ASP) have the potential to     become a means of ensuring PA among young schoolchildren. This requires a motivational     climate, allowing for self-determination and the intrinsic values of the activity, on the     activity's character of play. ASP staff could be trained in stimulating all children in     physical activities in their everyday life. Physiotherapists in primary care possess     knowledge of motor development and learning, and are important contributors to an ASP-based     physical activity intervention.      Aim: To develop a complex intervention that emphasizes physical activity play, and to examine     through a cluster-randomized trial the extent to which the intervention promotes PA and     health-related quality of life and prevents overweight in a population of young children. We     aim to increase the knowledge and autonomy supportive skills among ASP staff members,     enabling them to promote physical activity through play among all first graders in ASP.      In addition to investigate if the children benefit from receiving autonomy support, we aim to     study whether the ASP staff themselves benefit from giving autonomy support in terms of     increased need satisfaction and autonomous motivation for work.      The intervention: Includes training of ASP-staff members in the fundamental principles of     self-determination theory and practical applications for motivating young children in PA     through play. Information will be given on the benefits of a physically active lifestyle and     the staff will be encouraged to map opportunities for PA in their local ASP and to     incorporate strategies to increase PA through play among the children throughout the day.      Methods/design: A complex intervention using a mixed methods approach will be developed and     evaluated. A pilot trial will assess the potential of this approach and provide information     necessary to perform a cluster-randomized controlled trial (RCT). The cluster-randomized     controlled trial (RCT) will together with qualitative interviews and observations, evaluate     the effectiveness of the intervention. Outcomes will be measured at baseline (September     /October 2016) at the end of the intervention which lasts for 7 months (May 2017), and 1 year     after the end of the intervention (May 2018)   "
25293|NCT02954601|"     This study will enroll approximately 30 adult subjects with T2DM from age 20 to 75 inclusive.      Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind     placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will     include three treatment assignments for each of three treatment Periods according to the     randomization scheme.   "
25294|NCT02954588|"     A growing body of evidence demonstrates that increased adipose mass, especially visceral     adipose tissue, contributes directly towards an increase in systemic inflammation,     (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin     resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a     heterogeneous family of unavoidable by-products, which are formed by reactive metabolic     intermediates derived from glucose and lipid oxidation. In addition to the overwhelming     amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular     dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue     contributes to the dysregulation of adipokines and the development of insulin resistance.      The investigators want to examine, in a double-blind randomized placebo controlled parallel     study, the physiological effect of a dietary intervention with pyridoxamine in abdominally     obese persons.   "
25295|NCT02954575|"     The purpose of this study is to obtain additional data on the safety and efficacy of Wilate     in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII     concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs,     thus supplementing the existing database to obtain approval of Wilate for the indication     hemophilia A in the USA.   "
25296|NCT02954562|"     In this study, people will be undergoing brain scans with functional magnetic imaging (fMRI)     while they perform an emotional regulation task that involves observing either neutral images     or images known to induce negative emotions, with instructions either to view passively or     attempt to reduce the negative affect associated with the images. Resting state brain scans     (with no explicit task) will also be acquired. Heart rate variability will be measured during     these resting state scans. While in the scanner, subjects will also listen to prerecorded     audio scripts about life stresses for themselves and for another person with instructions to     practice compassion for themselves or for others. In yet another task, they will respond to     pictures known to produce positive and negative emotions and perform an attention related     task. The scans will take place once before and at least once after undergoing sessions of     methylenedioxymethamphetamine (MDMA) assisted psychotherapy. Brain scans will happen three     times: an initial scan before placebo or MDMA-assisted psychotherapy, a second scan after     either two placebo or two MDMA sessions (depending on whether the subject was in the placebo     or MDMA group), and one final scan after the conclusion of three active MDMA sessions.   "
25394|NCT02953275|"     The purpose of this study is to determine the synergistic effect and clinical benefits of     vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.   "
25297|NCT02954549|"     A genomics-based approach will target specific genes that may explain the response in     biomarkers and symptoms before and after supplementation. One objective is to generate     evidence-based recommendations for vitamin D supplementation in Soldiers who often experience     musculoskeletal disorders and immune dysfunction impacting physical performance and military     readiness. The investigation is designed to address these specific aims: 1) explore vitamin D     status in 105 Service Members to determine common symptoms associated with deficiency; 2)     examine the effect of vitamin D levels on gene expression from select genes known to     influence metabolism, bone density, and immune function; and 3) evaluate changes in gene     expression between groups receiving high or low supplementation, and compare to healthy     controls. Follow-up at 15 months will evaluate circulating vitamin D.   "
25298|NCT02954536|"     The purpose of this study is to find out what effects, good and/or bad, pembrolizumab in     combination with trastuzumab and chemotherapy, has on the patients' esophagogastric cancer.   "
25299|NCT02954523|"     This is a study for patients with advanced non-small cell lung cancer with changes to their     cancer cells called EGFR mutations. Mutated EGFR is important in the growth of cancer cells.     Medical studies have shown that patients with EGFR mutation-positive lung cancer gain more     benefit from targeted therapy drugs such as EGFR inhibitors than with standard chemotherapy.     However, a significant proportion of patients carrying these sensitizing mutations do not     respond well to the first-generation EGFR-TKIs (erlotinib and gefitinib), indicating the     existence of intrinsic resistance mechanisms. Moreover, despite initial response to     EGFR-TKIs, acquired resistance is inevitable in all patients.      The investigators have recently shown that Cripto-1 overexpression in EGFR mutant NSCLC     contributes to the intrinsic resistance to EGFR-TKIs through activation of the SRC oncogene.     They have also shown that a combination of an EGFR-TKI (both erlotinib and osimertinib) and a     Src inhibitor are synergistic in Cripto-1 overexpressing tumors in the laboratory.      This study will be testing a combination of two drugs, dasatinib and osimertinib, to overcome     resistance to EGFR-TKIs. Osimertinib (AZD9291) is a third-generation EGFR-TKI, which     selectively blocks the activity of EGFR mutants, but spares that of wild type. The advantage     of using osimertinib is that it inhibits not only the sensitizing EGFR mutations, but also     the T790M mutant, which is the most common mechanism of acquired resistance. Dasatinib is a     potent, orally available ABL1/SRC TKI, approved for the treatment of chronic myeloid leukemia     (CML) in first-line and in patients with imatinib-resistant disease or intolerant, and is     being actively studied in patients with advanced solid tumors.      The first part of the study will involve finding the highest dose of dasatinib that can be     given with osimertinib without causing severe side effects, finding out the side effects seen     by giving dasatinib at different dose levels with osimertinib, and measuring the levels of     dasatinib and osimertinib in blood at different dose levels. The second part will determine     the effects of the combination of dasatinib and osimertinib and determine if the amount of     Cripto-1 protein in your tumor or blood makes you more likely to have a good response to the     combination of dasatinib and osimertinib.   "
25301|NCT02954497|"     PumpKIN is a randomized, multicenter, two-arm trial evaluating the investigational Jarvik     2015 VAD versus the EXCOR® Pediatric VAD in pediatric patients with heart failure. This study     will enroll 88 subjects, 44 receiving the Jarvik 2015 and 44 receiving the EXCOR®, at up to     24 sites in the US and Canada.      The primary objectives of this investigational device exemption (IDE) clinical investigation     are to (1) assess the safety of the investigational Jarvik 2015 through the evaluation of     reported serious adverse events (SAEs) while on ventricular assist device (VAD) support up to     the first 180 days post-implant and (2) explore the probable benefit of the investigational     Jarvik 2015 by evaluating overall survival in the absence of severe neurologic impairment.   "
25302|NCT02954484|"     This study aims to provide high quality evidence from a double-blinded, randomized controlled     trial on the efficacy of perioperative pregabalin in reducing morphine requirements,     improving pain scores and reducing chronic neuropathic pain when compared with placebo for     primary total knee arthroplasty. It hence aims to improve on choice of analgesia adjuncts for     total knee arthroplasty.   "
25303|NCT02954471|"     This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian     participants diagnosed with breast cancer between 2007 and 2013 and with available human     epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through     2015.   "
25304|NCT02954458|"     This study will follow subjects who completed the TED-C14-006 study. The purpose of this     study is to evaluate the long-term safety and efficacy of teduglutide in pediatric subjects     with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible     subjects, regardless of treatment received in TED-C14-006.   "
25305|NCT02954445|"     The overall purpose of this study is to explore the therapeutic effect of BCMA-targeted     chimeric antigen receptor T(CAR-T) cells in the treatment of B-cell derived malignancies.   "
25306|NCT02954432|"     The purpose of this study is to assess the effects of tDCS in combination with TUS for the     treatment of pain and functional limitations in subjects with NSCLBP. The investigators     hypothesize that there will be a decrease in pain levels with active stimulation, when     compared to sham stimulation.   "
25307|NCT02954419|"     This prospective cohort study is designed to examine the association between blood and urine     biomarkers (including genetic variants) and long-term kidney disease progression among 2000     Chinese IgA nephropathy patients with relatively normal kidney function (eGFR≥60 ml/min/1.73     m2).   "
25308|NCT02954406|"     The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended     Phase 2 dose (RP2D) of TAK-659 when administered in combination with bendamustine,     bendamustine + rituximab, gemcitabine, lenalidomide, or ibrutinib.   "
25309|NCT02954393|"     The aim of this multicenter randomized clinical trial is to compare the clinical,     microbiological and immunological effects of the adjunctive use of systemic metronidazole     plus amoxicillin administered in different phases of the treatment of generalized chronic     periodontitis.   "
25310|NCT02954380|"     The aim of our study is to investigate if LTCM's are superior to implantable loop recorders     in detecting atrial fibrillation after pulmonary vein isolation. This study will provide     insights on a possible alternative for detection of arrhythmia.   "
25311|NCT02954367|"     The aim of this project is to investigate the potential benefits of combining a new protein     meat hydrolysates extract with a regular endurance training programme on (a) body composition     (b) performance (c) muscle structure (d) immunology and (e) microbiota (f) haematological     markers in endurance athletes   "
25312|NCT02954354|"     The primary objective of this study is to evaluate the efficacy of a single, oral dose of     S-033188 compared with placebo by measuring the time to alleviation of symptoms in patients     with uncomplicated influenza virus infection.   "
25314|NCT02954328|"     The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous     every day phenomena. For example, people frequently walk while talking on a cellphone or     drive while talking to a passenger. Often, the performance of one or more of these     simultaneously performed tasks may deteriorate when another task is carried out at the same     time, even in healthy young adults. This reduction in performance is referred to as the DT     deficit or DT cost and is typically much higher in Idiopathic Fallers (IF) than in     age-matched controls. In this population the DT cost impairs the gait pattern, as manifested,     for example, in increased gait variability, exacerbating instability and fall risk.      In the proposed study, would be evaluated the effects of tDCS on dual tasking performance     following tDCS.      The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will     increase DT performance and prefrontal activation.   "
25315|NCT02954315|"     Investigators hypothesize that regular consumption of almonds will augment the long chain     fatty acid profile and the alpha-tocopherol levels, improve the skin barrier function, and     improve the appearance of facial wrinkles in post-menopausal women.   "
25316|NCT02954302|"     This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be     reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard     gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).   "
25317|NCT02954289|"     Prostate cancer is one of the most commonly diagnosed cancers in Canada, with 24,000 new     cases estimated for 2015. Prostate cancer patients often live with uncomfortable side effects     of treatment, such as a decrease in bone health, weight gain, and challenges to their     interpersonal relationships. Nutrition can improve outcomes for PCa survivors; however,     dietary interventions for prostate cancer patients are limited. Therefore, this is a     feasibility study that tests the impact of an innovative intervention to promote healthy     nutrition and weight control for prostate cancer survivors and their partners.      The objectives are to assess the feasibility of the intervention, specifically:        -  Accrual, retention and adherence, and participant satisfaction        -  Candidate measures for primary outcomes in future studies      The intent is to evaluate how well the classes work and identify ways to make them more     successful. At the end of the study, the investigators will know if this approach shows merit     to be tested further through a randomized controlled trial.   "
25318|NCT02954276|"     the trial is a randomized, open label, crossover, single-administration bioavailability study     to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual tablet     versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers.   "
25320|NCT02954250|"     Background: According to the World Health Organization, one million people die by suicide     each year worldwide and the rate of attempted suicide is ten times greater. A less known fact     is that suicide is 3 times more frequent in elderly adults compared to younger counterpart.     Unfortunately, predicting and preventing suicidal behaviours (SB) in general, and in elderly     in particular, remain difficult. Clinical, biological and genetic data suggests that SB may     be best understood according to a stress-vulnerability model where, more vulnerable     individuals are at increased risk of committing a suicidal act when experiencing (mostly     social) stress. Vulnerability to SB has also been associated with specific (i.e. distinct     from comorbid psychiatric disorders like depression) neurocognitive alterations. However, the     neurocognitive basis of suicidal behavior in elderly has been more rarely investigated.      Aim: Mindfulness based cognitive therapy (MBCT) has been successfully used to treat many     psychiatric symptoms in many different populations, given that this therapy reduces cognitive     creativity. Thus, this pilot study aims at addressing the SB in older adults with a Modified     Mindfulness Based Cognitive Therapy (MMBCT).      Hypotheses: We hypothesise that MMBCT is not only a feasible intervention in older people     with SB, but also, effective to treat depressive symptoms and suicidal ideation.     Additionally, we will explore the changes in cognitive testing.      Methods: This is a pilot randomized controlled trial of a MMBCT tailored to older adults with     depression and suicidal behaviors at the Douglas Mental Health University Institute. Patients     with depression Hamilton Depression Rating Scale (HAM-D) >10 and suicidal ideation (Scale for     Suicide Ideation [SSI] score ≥1) will be randomized to MMBCT or usual care. The meditation     intervention will involve doing seated 90minute/week meditation exercises for 8 weeks. The     primary outcomes will examine feasibility and acceptability of the treatment. The secondary     outcome measures will scores in HAM-D and we will control for any important covariates     differing between groups, (e.g. age, sex, # medical illnesses).      Perspectives: Implementation of these interventions could potentially prevent many     consultations to psychiatry/mental health professionals. Increase quality of life, decrease     medical comorbidity, illness and mortality. [2] Taken together, in our rapidly aging     population, this could translate to substantial savings in health costs.   "
25321|NCT02954237|"     The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™     Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug     after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single     arm, post approval, observational study. The clinical study will be conducted at up to 35     sites in China. Approximately 343 subjects will be enrolled in this study.      The total study duration is expected to be approximately 7 years. Patients who have     non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral     anticoagulant; or patients who experience stroke or other thromboembolic event despite taking     warfarin.      Scheduled office visits occur at (45 days+ 2 weeks), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and     24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6     weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.   "
25322|NCT02954224|"     Delirium is a common complication in elderly patients following surgery. Patients who develop     delirium after surgery are at increased risk for serious complications, and even death.This     multi-centre randomized controlled trial will enroll elderly patients scheduled for elective     hip/knee replacement surgery.The objective of this trial is to identify obstructive sleep     apnea using ApneaLink Air and to determine whether auto-titrating CPAP treatment of     obstructive sleep apnea will decrease the incidence of post-operative delirium in elderly     patients undergoing elective hip and knee replacement surgery.   "
25323|NCT02954211|"     The purpose of this study is to determine the characteristics that distinguish responders     from nonresponders in people with stroke receiving rTMS combined with physical therapy to     improve hand function. Investigators hypothesize that those who improve the most will be     characterized by larger evoked brain signals in the stroke hemisphere and lower scores on the     Beck Depression Inventory indicating less depression. Medications, sex, age, type of stroke,     location of stroke, duration of stroke and baseline hand function will also be compared.   "
25405|NCT02953132|"     The purpose of this study is to investigate the safety and tolerability of ascending single     and multiple oral doses of MT-4129 in healthy subjects.   "
25325|NCT02954185|"     Preliminary evaluations have been completed and resulted in patients and therapist indicating     positive outcomes through increased patient engagement, asynchronous communications (i.e.     messaging) between therapists and patients, and objective assessment and monitoring of     exercises performed by the patients. The investigator's hypothesis is that patients using the     Wellclub device and application in addition to in-clinic physical therapy will be more     compliant with their home exercise programs and have the same or better functional outcomes     than patients with similar conditions who use in-clinic care only.   "
25326|NCT02954172|"     A randomized, double blind, multicenter phase3 study .   "
25327|NCT02954159|"     The aim of this study is to assess if a combination therapy of tacrolimus and vedolizumab is     superior to vedolizumab monotherapy for induction of remission in moderate to severe UC, and     its effect on long and short-term outcomes including colectomy rate. Secondary aim of this     study is to assess the safety of tacrolimus as an induction agent in patients with UC.   "
25328|NCT02954146|"     The purpose of this study is to examine feasibility, tolerability, utilization, and     effectiveness of using the SupportTeam mobile application in the context of Cognitive     Behavioral Therapy (CBT) for veterans with PTSD.   "
25329|NCT02954133|"     The aim of the study is to determine if, and to what degree photobiomodulation treatment with     OrthoPulse has an effect on the rate of tooth movement during alignment for patients     receiving Invisalign orthodontic aligner treatment.   "
25330|NCT02954120|"     Background: The aim of this study was to investigate the levels of malondialdehyde (MDA),     total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and     saliva samples in female patients with chronic periodontitis (CP) and to compared healthy     individuals.      Materials and Methods: A total of 88 women were into four groups each which were consisted of     twenty-two subjects. Groups were designed as periodontally and systemically healthy women     (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-),     systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum     and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS,     8-OHdG levels were measured as biochemically.   "
25331|NCT02954107|"     This longitudinal study will focus on the cognitive and brain development of children with     absence epilepsy. In addition, the investigators aim to identify prognostic factors for     cognitive deterioration and/or poor seizure control in these children.   "
25332|NCT02954094|"     TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual     clinical practice. TARGET-HCC will create a research registry of participants with HCC within     academic and community real-world practices in order to assess the safety and effectiveness     of the entire spectrum of current and future therapies across diverse populations.   "
25337|NCT02954029|"     Arterial access is the key step during the endovascular treatment of cardiovascular diseases.     This study was designed to confirm the safety and efficacy of the hemostasis pad using     chitosan in patients undergoing percutaneous procedures with arterial approach. Two cohorts     will be included in this study: transradial and transfemoral cohort. Among the transfemoral     cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad     (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized     regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation     pathway. The hypothesis will be tested among the transradial cohort that the combined use of     a hemostasis pad and a compression device is superior to that of a compression device only in     terms of hemostasis in patients who underwent tranradial coronary procedures.   "
25338|NCT02954016|"     To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System     for treatment of adults with severe obesity.      The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35     and ≤ 50 kg/m2 who have failed more conservative weight loss methods.   "
25339|NCT02954003|"     The purpose of this study is to collect clinical data to support the use of the ValenTx Endo     Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.   "
25340|NCT02953990|"     This study will provide information about the feasibility, acceptability, and preliminary     effects of a biobehavioral self-management approach for perinatal depressive symptoms. This     line of research will contribute to the body of knowledge about adjunctive therapies for     depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child     outcomes. Ultimately, this will contribute to the development and implementation of     theoretically driven depression prevention/ resiliency building interventions and measurement     of appropriate biobehavioral outcomes to determine the effectiveness of interventions.   "
25341|NCT02953977|"     SMSC will inform the design and implementation of culturally informed, community-based     lifestyle interventions for diabetes prevention in AI men in our partner communities and     elsewhere, as well as in men of other minority groups who experience a heavy burden of     diabetes.   "
25342|NCT02953964|"     The purposes of the study are:        -  To evaluate the effectiveness of a perceptual-based training program in enhancing          cognitive and everyday functioning of older adults with mild cognitive impairment and          mild dementia        -  To evaluate the effectiveness of a semantic-based training program in enhancing          cognitive and everyday functioning of older adults with mild cognitive impairment and          mild dementia   "
25343|NCT02953951|"     The hemolytic product free-hemoglobin (fHb) reduces nitric oxide (NO) bioavailability. The     present study aims to establish whether transfusions of stored allogenic blood or     intraoperative autologous salvaged blood result in increased circulating fHb levels and NO     consumption with effects on arterial NO-dependent blood flow measured in isolated left     mammary artery rings and by peripheral artery tonometry in patients undergoing CABG surgery.   "
25344|NCT02953938|"     This is a Phase IV, randomized, open-label, active-controlled, 2-arm, multicenter study. The     primary objective will be assessed by the difference in the mean number of ranibizumab     injections applied up to Month 11 between the 2 treatment arms. Patients will be randomized     in a 1:1 ratio to 1 of the 2 treatment arms; i.e. Arm 1 ranibizumab monotherapy, Arm 2     ranibizumab with Grid&Direct short pulse laser photocoagulation combination therapy. There     will be 3 periods in this study: Screening Period (visit 1), Treatment Period (visit 2 to     Visit 13) and Follow-up Period (visit 14). In addition to screening and Baseline (visit 2),     there will be monthly visits from Month 1 to Month 12. This study will include male and     female patients (≥20 years old) diagnosed with visual impairment due to ME secondary to BRVO.     Assuming an approximate 20% drop out rate, approximately 70 patients will need to be screened     to have at least 56 patients found eligible and commencing treatment in the trial.   "
25345|NCT02953925|"     The survey aims to support health policy making, this survey aims to comprehensively assess     the capability and quality of PHC in different regions in China. The study is based on the     China PEACE MPP network, including about 4000 rural and urban primary health care     institutions scattered over 31 provinces in Mainland China. The investigators intended to     enroll about 30,000 PHC healthcare providers. Meanwhile, the investigators drew a random     samples (>50,000) of patients from MPP high-risk of CVD population. In this survey, data on     structure, process, and outcome of PHC system in China will be collected by questionnaires,     specified by organization, healthcare providers and patients. Meanwhile, the investigators     will collect the original documents from participating PHC institutions, covering the aspects     of finance, employment, essential medical list (EMS), public health service report and     prescriptions. The investigators will analyze data in align with key indicators, to assess     the capability and quality of PHC across different regions in China.   "
25346|NCT02953912|"     To show whether One Shape rotary system differs from Reciproc reciprocating system in     postoperative pain in patients with symptomatic irreversible pulpitis.   "
25347|NCT02953899|"     The purpose of this project is to pilot contingency management as an adjunct treatment to     counselling as usual using internet delivered video-conferencing applications for remote     disordered gamblers. This project further investigates the impact of adding contingency     management to counselling to improve counselling attendance and retention and uses     internet-delivered approaches to assist rural and remote disordered gamblers gain access to     counselling treatments.   "
25348|NCT02953886|"     The study will compare bacteria levels in cavities before and after silver diamine fluoride     (SDF) treatment.   "
25349|NCT02953873|"     Compare the difference in dose-normalized trough and total daily dose necessary to reach the     steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African     American kidney transplant recipients.   "
25350|NCT02953860|"     A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to     fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive and     Her2 normal.   "
25351|NCT02953847|"     3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing     FDCs vs a single drug comparator in healthy volunteers   "
25352|NCT02953834|"     This study examines how a naturally occurring peptide called Kisspeptin might regulate blood     sugar and insulin levels.   "
25354|NCT02953808|"     This is the first study in which GSK2315698 will be administered in Japanese population. The     primary objective of the study is to investigate safety and tolerability, pharmacokinetics,     and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a     single center, double-blind, randomized, placebo-controlled, dose-ascending study.      Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3     groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose levels     of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to be     administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be     separated by a washout period of at least 8 and 10 days, respectively.      Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive     either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours.      A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort)     complete the study. The duration of participation for any subject in this study will be     approximately 59 days.   "
25355|NCT02953782|"     This trial will evaluate Hu5F9-G4 in combination with cetuximab. Hu5F9-G4 is a monoclonal     antibody which is designed to block a protein called CD47, which is widely expressed on human     cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and     destroy the cancer cells. Cetuximab is a monoclonal antibody drug that is used for treatment     of certain types of colorectal cancer as well as head and neck cancer.      The major aims of the study are: (Phase 1b) to define the safety profile and to determine a     recommended Phase 2 dose for Hu5F9-G4 in combination with cetuximab, and (Phase 2) to     evaluate the objective response rate of Hu5F9-G4 in combination with cetuximab in patients     with advanced colorectal cancer.   "
25356|NCT02953769|"     Comparison of ventral hernia repair using standard wound care versus Prevena.   "
25357|NCT02953756|"     Stereotactic radiosurgery (SRS) is increasingly applied in patients with brain metastases     (BM) and is expected to have less adverse effects on cognitive functioning than Whole Brain     Radiation Therapy (WBRT). Because cognitive functions are essential for daily functioning,     and may affect therapy compliance and quality of life in general, a full understanding of     cognitive functioning in patients with BM after SRS is essential.      CAR-Study A is a prospective study to evaluate cognitive functioning in patients with 1-10 BM     accepted for treatment with Gamma Knife radiosurgery (GKRS).   "
25360|NCT02953717|"     Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients     with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been     increasingly employed in the management of multiple BM to spare healthy tissue. Hence, GKRS     is expected to cause fewer cognitive side effects than WBRT. Treatment of multiple BM without     cognitive side effects is becoming more important, as more patients live longer due to better     systemic treatment options. There are no published randomized trials yet directly comparing     GKRS to WBRT in patients with multiple BM, including objective neuropsychological testing.      CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT     in eligible patients with 11-20 BM.   "
25361|NCT02953704|"     The purpose of this prospective, longitudinal, noninterventional study is to describe     clinical characteristics, evolution of disease burden, and treatment patterns in patients     with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).   "
25362|NCT02953691|"     The overall objective of this proposal is to explore the association between the     administration of the prebiotics GOS (trade name: Bimuno Travelaid; generic name:B     galacto-oligosaccharides) with pain, anxiety, and cognitive function in the perioperative     period. The investigators' central hypothesis is subjects who consume GOS in the     perioperative period will demonstrate lower levels of salivary cortisol before, during, and     after their operative procedures. In addition, the investigators expect subjects who consume     GOS to have lower perceived levels of anxiety during the perioperative period. Finally, the     investigators hypothesize that subjects who consume perioperative GOS will perform better on     tests of cognition in the postoperative period. Such a finding would be beneficial in that     administration of GOS in the perioperative period offers a safe and inexpensive adjunct to     current medical management of perioperative anxiety.   "
25363|NCT02953678|"     The purpose of this study is to assess the efficacy of ruxolitinib in combination with     corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host     disease (GVHD).   "
25364|NCT02953665|"     The purpose of this study is to test the efficacy and safety of liraglutide in the treatment     of patients with idiopathic Parkinson's disease (PD).   "
25365|NCT02953652|"     Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, efficacy, and     pharmacokinetics of HBI-8000 40 mg BIW in patients with relapsed or refractory PTCL (R/R     PTCL).   "
25366|NCT02953639|"     This multicenter study will assess the effects of 24 weeks of basmisanil treatment on     cognition and functioning of stable CIAS participants treated with antipsychotics.   "
25367|NCT02953626|"     Postpartum depression is common, yet only 20% of women seek treatment. Online support groups     are a potential means of providing accessible mental health care during this time. Mother     Matters is a 10-week online psychotherapy group for women with postpartum depression &     anxiety. The investigators aim to conduct a pilot RCT to demonstrate the feasibility of     proceeding to a large-scale RCT evaluation of the Mother Matters intervention.   "
25368|NCT02953613|"     The goal of this study is to correlate both plaque and % lipid core content assessed by     NIRS-IVUS (Imaging technique) to plaque burden and % lipid core content in coronary     computerized tomographic angiography (CCTA) completed at 1 week in non-culprit coronary     arteries.   "
25369|NCT02953600|"     Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per     year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat,     long-term, and severe chronic hepatitis would be more possible progressed into liver     cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would     progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC.     In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis     phase.   "
25370|NCT02953587|"     The purpose of this study is to determine if the altered nutrient exposure to the GI tract     after bariatric surgery reveals a negative incretin effect of ghrelin.   "
25372|NCT02953561|"     The goal of Part A is to find the highest tolerable dose of avelumab that can be given in     combination with 5-azacytidine to patients with relapsed or refractory AML. The goal of Part     B is to learn if the highest tolerable dose of this drug combination found in Part A can help     to control the disease.      The safety of this drug combination will also be studied in both parts of the study.   "
25373|NCT02953548|"     This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,     and an open-label extension phase. The pilot phase only will be described in this record. 2     cohorts of 5 participants will be enrolled sequentially. All participants will receive     GWP42003-P.   "
25374|NCT02953535|"     Comparative randomized, single dose, three way three sequence two treatment partial replicate     crossover open-label study to determine the bioequivalence of Sofosbuvir from Magicbuvir 400     mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences,     Canada)   "
25375|NCT02953522|"     The C677T polymorphism in the MTHFR gene is related to several significant biochemical     changes, as dyslipidemia, changes in serum levels of homocysteine, folic acid, vitamin B12     and some oxidative stress markers such as the CAT and MDA, leading to a high risk of the     emergence of cardiovascular disease (CVD). A diet containing antioxidants, especially folate,     is characterized by being beneficial for individuals with this genetic alteration to possess     anti-inflammatory function, act on and oxidative stress play an important gene function. The     aim of this study was to evaluate the influence of the C677T polymorphism of the MTHFR gene     and the effect of a diet containing folate on oxidative stress, lipid profile and     homocysteine levels in adult women are overweight or obese. This is an intervention study,     double-blind, held in a city in northeastern Brazil. The study included 48 adult women (20-59     years old) with BMI of 26.19 kg / m² and 49.64 kg / m², in which we evaluated the CAT levels,     MDA, lipid profile, folic acid, homocysteine and vitamin B12 addition genotyping for the     C677T polymorphism in the MTHFR gene and the food consumption by the food recall 24 hours,     being divided by randomization into two groups received daily for 8 weeks, 300g vegetables     rich in folate containing 191 ug and 90 ug of this nutrient.   "
25376|NCT02953509|"     This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a     monoclonal antibody which is designed to block a protein called CD47, which is widely     expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune     system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is     used for treatment of non-Hodgkin's lymphoma and other types of cancer.      The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of     sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in     combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in combination     with rituximab in patients with indolent lymphoma or diffuse large B-cell lymphoma as     measured by the overall response rate.   "
25377|NCT02953496|"     The research study is designed to assess the technical feasibility and safety of percutaneous     administration of vonapanitase to the superficial femoral or popliteal artery in patients     with PAD.   "
25378|NCT02953483|"     The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They will     be connected to a ventilator and preservative solution will be circulated through it . Blood     will be added to the fluid depending on the group to which the lungs are allocated and its     effects on lung function will be seen   "
25379|NCT02953470|"     The aim for the study is to examined the effect of an individually tailored integrated     behavioral medicine in physiotherapy intervention including functional exercise, for older     adults, having chronic musculoskeletal pain, living alone and dependent on formal care.      The study is a pragmatic randomized controlled trial with one intervention group and one     control group. The intervention is a 12-weeks home-based program. The intervention consists     of an individually tailored intervention and aims to enhance ability to perform everyday     activities by improving physical function and reduce pain-related beliefs and pain-related     disability. The comparison group achieves general advice about physical activity. All     participants will be tested at baseline, a post-assessment at 12 week and a three month     follow-up. Primary outcome is pain interference by the Brief Pain Inventory and physical     function by Short Physical Performance Battery.      Secondary outcomes measures if the goal setting is reached, self-efficacy in relation to the     goal setting, pain catastrophizing, level of physical Activity, falls efficacy and Health     related quality of life.   "
25380|NCT02953457|"     This phase I/II trial studies the side effects and best dose of olaparib when give together     with durvalumab and tremelimumab and to see how well they work in treating patients with     ovarian, fallopian tube, or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation     that has come back or has not responded to treatment. Drugs, such as olaparib, may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and kill tumors     cells with BRCA1 or BRCA2 mutation. Monoclonal antibodies, such as durvalumab and     tremelimumab, may help stimulate the immune system in different ways to attack and stop tumor     cells from growing. Giving olaparib with durvalumab and tremelimumab may work better in     treating patients with ovarian, fallopian tube, or primary peritoneal cancer.   "
25381|NCT02953444|"     This study will assess the efficacy of brief mindfulness practices on improving mental health     in adults who are currently in treatment for mental health concerns. From online     instructional videos, each participant will learn a thirty-second or three-minute mindfulness     practice that is to be performed at least three times daily over two weeks.   "
25382|NCT02953431|"     This is an early phase clinical trial to test the efficacy of elevating lung volume with     positive expiratory pressure (PEEP) as a controller therapy for asthma in patients with a BMI     ≥ 35 kg/m2.      There will be two phases to this trial.      Phase I:      In the first phase we will determine the optimal duration of PEEP that is effective as a     controller therapy in asthma. Up to 9 participants will complete this this phase.      Phase II:      The 2nd phase will be a randomized double-blinded controlled trial of PEEP 0 versus PEEP 10     (using the duration of PEEP determined in phase I) as a controller therapy for asthma. Twenty     participants will complete this phase.   "
25383|NCT02953418|"     Multicenter, prospective cohort clinical trial in greater China   "
25384|NCT02953405|"     Prescription and Persistence of Antithrombotic agents in Acute Ischemic Stroke or Transient     Ischemic Attack Patients with MCA(Middle Cerebral Artery) Disease.   "
25385|NCT02953392|"     Sixty patients with partially edentulous posterior maxilla requiring a transcrestal sinus     floor elevation technique to insert one implant will be selected. The purpose of this     multi-center, prospective, double blind, and randomized investigation is to analyze a     platform switched implant when placed at limited maxillary residual bone height with low bone     density compared to a platform matching implant with or without bone graft material.   "
25386|NCT02953379|"     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the     mometasone nasal gel in the treatment of allergic rhinitis.   "
25387|NCT02953366|"     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the     mometasone nasal gel in the treatment of allergic rhinitis.   "
25388|NCT02953353|"     The overall goal of this proposal is to evaluate the efficacy of transcranial direct current     stimulation (tDCS), a noninvasive neuromodulation technique, to facilitate weight loss and     weight loss maintenance in obesity. This is a novel clinical research study that examines the     therapeutic potential of an innovative biomedical treatment for weight loss.   "
25389|NCT02953340|"     The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in     patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to     prevent and reduce Neutropenia that is associated with cancer chemotherapy.   "
25390|NCT02953327|"     The propose is to test innate immune training in a pilot study of 40 adults >50 years of age     people in Guinea-Bissau. The hypothesis is that BCG vaccination will be associated with     increased innate immune training measured as increased cytokine release after in vitro     Peripheral Blood Mononuclear Cells (PBMC) stimulation with e.g. Mycobacterium Tuberculosis,     Staphylococcus Aureus, Candida Albicans and Streptococcus Pneumoniae.   "
25391|NCT02953314|"     This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the     PK, safety, and tolerability of multiple doses of VX-661 in combination with ivacaftor in     subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the     F508del-CFTR mutation.   "
25395|NCT02953262|"     Patient-facing eHealth technologies are those that connect patients and the healthcare     system, and include online patient portals. Although many organizations are adopting patient     portals, there is limited understanding of how the different portal features help improve     health outcomes. This study is designed to develop and test an intervention to improve     adoption and use of patient portal features for diabetes management.   "
25396|NCT02953249|"     Dental treatment to individuals with diabetes mellitus, particularly type 1 diabetes (T1DM),     has always represented a challenge to the dentist. The literature provides some scientific     evidence showing that diabetes is a risk factor for the occurrence of oral opportunistic     infections, abnormal bone metabolism and delay in tissue repair, but with varying degrees of     evidence.      Hyperglycemia, as well as diabetes, are known as risk factor for post-surgical infections, so     maintaining the glycemic control in the postoperative period has been standard to health     care. However, there are few studies on the impact of the glycemic control in the repair     process after tooth extractions. And, to our knowledge, there aren't evidences that     infections resulting from oral surgery are more frequent in individuals with diabetes or that     the antibiotics prophylaxis is needed for these individuals before invasive dental     procedures.      Some prospective studies show that people with diabetes, especially type 2 (T2DM), do not     exhibit higher frequency of complications in repair process after tooth extractions compared     to healthy individuals without diabetes. Recently, the study conduct by Fernandes et al.,     2015, found higher frequency of delay on epithelial covering of the alveolus after 21 days of     tooth extraction in individuals with T2DM, comparing to a control group. Delay was not     related to infection and on the day 60th after surgery, all alveolus were totally     epithelized. One of the author's hypothesis for the delay in the alveolar epithelialization     on the participants with T2DM was the possible reduction of Epithelial Grow Factor (EGF) in     saliva of these individuals. Some studies already demonstrated the reduction in salivary     detection of EGF in individuals with diabetes.      There aren't prospective studies in the literature at our disposal, that evaluated     intraoperative complications of tooth extractions of teeth already erupted in individuals     with T1DM, or even post tooth extraction healing and the chronology of epithelialization of     the alveolus and its relation with the degree of salivary EGF.      The aim of this study is to evaluated the intraoperative events and the post- tooth     extraction healing, regarding the chronology of the repairing events and the occurrence of     postoperative complications in individuals with T1DM compared to a control group. Besides,     this study intend to relate the time of complete epithelial covering of the alveolus with the     EGF collected by whole stimulated saliva.   "
25397|NCT02953236|"     This study aimed to verify the mechanical and clinical effects of instrumented massage on     myofascial trigger points of trapezius muscle in adult subjects.   "
25398|NCT02953223|"     To assess the frequency and nature of adverse events in infants fed a free amino acid based     infant formula.   "
25399|NCT02953210|"     The use of opioid during surgery can cause side effects and may delay hospital discharge.     Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and     and the time of discharge. In this compared controlled randomized study the aim is to     evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting,     postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia care     unit and hospital.   "
25400|NCT02953197|"     Treatment of cancers of the head and neck, including oropharyngeal tumours, usually consist     of a combination of radiotherapy and chemotherapy, although surgery may also play a part.     Radiotherapy works by using the high energy x-rays to destroy cancer cells. Head and neck     cancers often respond well to radiotherapy in the first instance and a proportion of patients     will be cured by this treatment. However, not all of the cancer cells are destroyed by the     combination of radiotherapy and chemotherapy and, in some patients, the cancer does come     back.      Studies have suggested that more efficient killing of cancer cells, and therefore, better     cure rates, can be achieved by increasing the radiotherapy dose. However, in the past, this     was not possible due to side effects. Intensity Modulated Radiotherapy (IMRT) is a new     radiotherapy delivery technique that allows better shaping of the dose to the areas that need     irradiating with the potential for fewer side effects. If the investigators use IMRT to     deliver an intentionally higher dose of radiation (called a boost) to small selected areas     whilst, at the same time giving standard treatment doses to the remaining areas, this     approach is called IMRT dose-painting. These selected areas can be identified by a scan     called 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography, also known as a     'PET' scan) which is a type of scan that can give information about the activity of a cancer.      The purpose of this study is to find out whether the investigators can use IMRT dose-painting     to boost the dose to the region inside a tumour which appears most active on 18F-FDG-PET. If     this study shows that this approach is well-tolerated, then the investigators may be able to     improve cure rates with this treatment. This would need to be tested in a subsequent study.   "
25401|NCT02953184|"     The regimen PLD plus cyclophosphamide 4 cycles followed by paclitaxel or docetaxel 4     cycles(noted in phase II CAPRICE) will be used as experimental group. The regimen will be     compared to the standard treatment of doxorubicin plus cyclophosphamide(AC) 4 cycles followed     by paclitaxel or docetaxel 4 cycles[noted in National Comprehensive Cancer Network (NCCN)     guideline].   "
25403|NCT02953158|"     This study will compare two energy reduced diets; one diet will include one Haas avocado/day     while the other diet will follow the usual American dietary pattern. All subjects will     receive a dietary plan that reduces their usual intake by 500kcal/day with the same     percentage of fat, protein and carbohydrates. The results from this study may help to explain     if eating one Haas avocado/day can achieve at least equivalent weight loss when compared to     the usual American diet.   "
25404|NCT02953145|"     Cleft Palate is a condition which affects up to 1 in 500 live births. Current treatment is     surgery to correct the underlying anomaly. Children born with cleft palate typically undergo     surgery at age 12 months. Standard ways to stop surgical bleeding include direct pressure and     the use of electrocautery (burning of the tissue). Other products are available to help     lessen blood loss. One of these includes a fibrin sealant. Fibrin is the key component of a     blood clot. When a fibrin sealant is applied there are a variety of potential benefits other     than bleeding control. One of these is decreased pain post operatively It is the     investigators belief that the use of a fibrin sealant, Tisseel, in cleft palate surgery will     decrease pain and enhance the recovery of children who undergo cleft palate repair.      The proposed study will randomly select children undergoing cleft palate repair to have     tisseel used on the incision. Through statistical tests 40 children will be recruited (20 to     have tisseel used and 20 with no tisseel). The use of tisseel will be known to the surgeon     but not to the recovery room or ward nursing staff. Post operatively, the FLACC pain scale     will be used to score the pain of the children throughout their admission to the Stollery     children's hospital. The amount of pain controlling medication required as well as time to     discharge will also be recorded. Statistical analysis of the data will be performed using     accepted methods. Overall, the investigators hope to show that fibrin sealant, tisseel, will     less the amount of post operative pain experienced by children undergoing cleft palate     repair.   "
25406|NCT02953119|"     Major abdominal surgery is a great stressor to patients and causes large physiological     changes, leads to tissue trauma, immobility, psychological distress and reduced quality of     life. Physical capacity appears to be an important predictor for postoperative recovery after     major abdominal surgery. Prehabilitation is a concept that challenges the traditional models     of recovery by initiating the recovery process preoperatively. Improvement of physical     capacity by means of prehabilitation may facilitate better recovery after surgery. More     specifically prior to major abdominal surgery, preoperative exercise therapy is associated     with improved physical fitness of patients, but whether or not this results in fewer     complications or faster convalescence remains unclear.      The aim of the present study is to evaluate the impact of preoperative physical exercise     training (prehabilitation) on postoperative recovery and clinical outcomes after major     abdominal surgery.   "
25407|NCT02953106|"     Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The     primary objective is to assess the additive effects of using combined intranasal fluticasone     propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients     with persistent asthma and allergic rhinitis, receiving inhaled steroid.   "
25408|NCT02953093|"     The investigators are studying the effects of acarbose on muscle and adipose gene     transcription in older adults.   "
25409|NCT02953080|"     PROTOCOL SUMMARY Abstract Current estimates point towards a huge increase in the number of     people that are eligible to start ART in Uganda and globally. As many of the newly eligible     patients are largely asymptomatic, there are concerns about adherence and retention of these     individuals and especially those starting ART with a higher CD4 counts. Urgent information is     required to plan for implementation of most recent WHO and National guidelines in the most     cost effective manner as well as maximizing retention of HIV positive individuals in care and     achieving virological suppression.      We plan to undertake research designed to see if we can optimize adherence, virological     outcomes and HIV knowledge, in order to give an overall increased quality of life in     vulnerable populations starting or established on ART in Kampala, Uganda. We will test     implementation of an open source software-based tool to send text messages and to give access     to an interactive voice response system to support self-monitoring and provide health     information using patients' mobile phones.      We aim to undertake an open labeled randomised trial at two sites: the IDI which is an urban     center of excellence in HIV care, and Kasangati Health Center, which is a peri-urban public     health care facility. The project aims to enroll patients starting ART, already established     on first line ART or switching to second line ART. We will include special populations     including pregnant women, discordant couples and young people. The estimated length of the     project is 30 months. The technology to be evaluated in this study is based on CONNECT FOR     LIFETM m-health technology (CFL2015.01 or higher). CFL2015.01 provides text messages or     Interactive Voice Response (IVR) functionalities, a technology that allows a computer to     interact with humans through the use of voice and tones input via keypad, including pill     reminders, clinic visit reminders, health tips and functionality to support symptom     reporting.      The Primary Objective of this study is to determine the effect of the CFL2015.01 tool on     quality of life of HIV patients receiving care at IDI and Kasangati HCIV. At the start of the     intervention, all patients will undergo quality of life assessment, which will be repeated at     months 6, 12 and 24 months. The scores will be compared to assess the effect of the tool on     quality of life. The Secondary Objectives are virological outcomes baseline, 6, 12 months and     24 months, retention in care, aversion of early treatment failure, disease knowledge, clinic     attendance and cost analysis.   "
25410|NCT02953067|"     This trial is designed to compare different treatments on Lisfranc fractures. The trial     consist of 2 different strata. Stratum 1: In mild injuries the comparison is between     conservative treatment and operative treatment with open reduction and internal fixation     (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with open     reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome measure     will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and Ankle.   "
25411|NCT02953054|"     The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch,     will provide adequate pain relief during the first 3 days following bunionectomy surgery.   "
25412|NCT02953041|"     The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either     as monotherapy or in combination, on the methacholine dose-response curve. This will allow     for further elucidation of the mechanisms of each drug in human participants.   "
25435|NCT02952742|"     This is a randomized, placebo-controlled crossover study. Participants will be actively     participating in the study for 6 months, and enrolled in the study for up to 1 year. During     the first phase of the study, the participants will be randomized into either the placebo     group or treatment group for 8 weeks following 1 week of baseline data collection (no     treatment). Following this first phase, a no-treatment washout period of at least 3 weeks     will be implemented for all participants. After the washout period, the randomized groups     will switch from treatment to placebo group, or placebo to treatment group for an additional     8 week period. Hot flash frequency and severity will be documented using a daily hot flash     diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life     will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS)     questionnaires.   "
25413|NCT02953028|"     Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during sleep     due to collapse of the oro-pharynx. The consequences are reduced quality of sleep, increased     risk for developing cardiovascular disease and increased risk of accidents caused by daytime     sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to 16%. The     golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP). This is     effective and must be used for life. However, CPAP-treatment might be uncomfortable for the     patient, with poor compliance as a result. An alternative is Mandibular Advancing Splints     (MAS), which is perceived as less troublesome and may initiate higher compliance. Through     mapping of patient characteristics, the researchers investigate which patient-type benefits     most from two different treatment-devices. The aim of the study is to assess how the MAS     treatment differ from the CPAP treatment in respect to efficacy, compliance and impact on     health related quality of life among patient diagnosed with mild/moderate OSA. All OSA     patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital,     Northern-Norway (UNN) were invited to participate in the study. The sample size at completion     of the study should be 140 patients. Participants in the trial were randomly allocated to the     two treatment groups, and assessed after 4 and 12 months of treatment. Data were collected     through anamnesis, clinical examination, clinical photos, radiographs and questionnaires     concerning general health related quality of life (SF36), oral health, cognitive aspects     (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's Sleepiness scale) and compliance.   "
25414|NCT02953015|"     Chronic migraine (CM) is a very disabling disorder with grave socioeconomic consequences.     Pharmacological approaches can affect mechanisms of pain production, while rehabilitation     such as Transcutaneous Electrical Nerve Stimulation and Manual Therapy may reduce the     neuromuscular contributing factors. The main aim of the study is to evaluate the effects of     cervical and thoracic manipulative techniques combined with OnabotulinumtoxinA prophylaxis on     headache frequency in patients with Chronic Migraine (CM). The second aim is to evaluate the     training effects on the intensity of headache attacks, analgesic consumption, cervical range     of motion, TrPs sensitivity and disability. The hypothesis is that the manipulative treatment     would alleviate CM symptoms and, in turn, decrease the analgesic consumption.   "
25415|NCT02953002|"     In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial.     After signing an informed consent a blood sample will be obtained from each participant. The     investigators will measure the thrombin generation in plasma assessed by the calibrated     automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be     calculated. The relation between SOFA score and thrombin measurements will be determined.   "
25419|NCT02952950|"     In this project 3 studies examined two possible explanations and one possible preventive     intervention to early cessation of exclusively breastfeeding in premature infants.      Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a     third higher than in the milk from the mother who delivers on time. The nutritional     composition changes over time and the content of protein decrease. Therefore the premature     infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing     content of protein can made up by adding, while it is more difficult when the infant is     exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is     associated to a fewer number of days where the premature infant is exclusively breastfed.      Study 2 The premature infant is characterized with immature muscle with a low tension and     therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of     milk from mother to child is an interaction between the mothers and her milk ejection reflex     that establish a positive pressure on the milk and the child that have to establish a vacuum.     The hypothesis is that the premature infants suction power is too weak to establish     sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can     be related to a fewer number of days where the infant is exclusively breastfed.      Study 3 The premature infants low muscle tone and its immaturity also influence on the     organization and the quality of movements, marked as neuro motor processes. These processes     form the oral motor base supporting movement which involves the infant ability to establish     vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before     the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to     create intra oral vacuum and thus the power to transfer milk from the breast, thereby     extending the number of days when the infant is exclusively breastfed.      200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1     the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant     suction is assessed by vacuum measurement. In study 3 the families are randomized to an     intervention or control group and parents off 100 infants are guided by occupational     therapists in a program of oral stimulation of their child.   "
25420|NCT02952937|"     The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR     GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg     administered regular diet and (2) determine the safety and tolerability of a single dose of     GLA5PR GLARS-NF3 tablet 300mg administered regular diet and GLA5PR GLARS-NF1 tablet 300mg     administered regular diet.   "
25421|NCT02952924|"     This study is sponsor-open, investigator-blinded, participant-blinded, randomized,     placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study that     will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of     RO7049389 following oral administration in healthy volunteers and chronic HBV infected     participants. The effect of food on the PK of RO7049389 and the effect of multiple dosing of     RO7049389 on the PK of a single oral microdose of midazolam will be evaluated. The study will     be conducted in two parts: Part 1 (1a [SAD cohort], 1b [Food-effect SAD cohort], 1c [MAD     Cohort]) in healthy volunteers and Part 2 (Proof of mechanism [POM]) in chronic HBV infected     participants.   "
25422|NCT02952911|"     This prospective pilot study will assess the feasibility of remote participant monitoring     using digital technology in participants with MS and healthy controls. At the enrollment     visit, the participants as well as the healthy controls will be provided with a remote     patient monitoring solution which includes preconfigured smartphone and smartwatch. The     configured smartphone and smartwatch pair will contain application software that prompts the     user to perform various assessments, referred to as active tests and passive monitoring.     Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test,     electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS     Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive     monitoring will be done to collect metrics on gait and mobility throughout the daily life of     participants in a continuous and unobtrusive manner.   "
25423|NCT02952898|"     This research study is being done to compare the safety and effectiveness of GDC 695 (test     drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to     establish that these two drugs work better than placebo in the treatment of actinic     keratosis.   "
25448|NCT02952573|"     This is a phase 2 study to see how effective investigational drug, JNJ-42756493, is when     given in combination with dexamethasone in two groups of patients with multiple myeloma     (cancer of the plasma cells, a type of white blood cell present in bone marrow) that has     relapsed (has come back after a period of improvement) or refractory (did not respond to     standard treatment).   "
25424|NCT02952885|"     Acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on     the pituitary gland, which leads to excessive production of growth hormone (GH). GH excess in     turn causes overproduction of another hormone called insulin-like growth factor-1 (IGF-1).     IGF-1 levels are currently the most widely accepted measure of disease activity.      In Canada, medical therapy with a type of medicine called somatostatin analogues (SSA),     such as octreotide and lanreotide, is recommended for treatment of acromegaly. However,     studies have shown that a significant number of patients who take SSA medications alone     remain with elevated levels of IGF-1 in their blood.      Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the     investigators plan to study whether strict control of IGF-1, by adding or optimizing the use     of PEGV, results in a significant health benefits to patients who still have modestly high     levels of IGF-1 in their blood.   "
25425|NCT02952872|"     The project seeks to develop an effective computer-delivered brief intervention to reduce     alcohol use using the Multiphase Optimization Strategy (MOST). Sixteen different versions of     the intervention will be tested with manipulation of common factors (empathy & positive     regard), use of a voice, and use of an animated narrator. Participants will include 352     undergraduate students randomly assigned to one intervention condition; follow-up assessments     will take place at one and 3 months. The main outcome will be means drink per day over the     past 30 day.   "
25426|NCT02952859|"     Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after colon     and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland, 1,172     new pancreatic cancer patients were diagnosed in 2012. Unfortunately, only about 20% of     pancreatic cancer patients present at a disease state that allows surgical resection while     30% have locally advanced, unresectable disease and 50% show distant metastases. While the     latter two are currently treated in a palliative setting with median survival of at most 6-12     months, patients who undergo tumor resection with curative intentions also achieve only     5-year survival rates of 20-25% in best hands. The reasons for this poor outcome are thought     to be chemoresistance, early establishment of metastatic disease, and importantly, high rates     of R1 resections. Up to 80% of pancreatic resections have positive resection margins which     are often found within the vascular groove and/or at the retroperitoneal margin, close to the     superior mesenteric artery. This high rate of positive margins is only found after meticulous     pathological work-up and is normally not detected after standard assessment of the specimen.     However, the clinical importance of the high positivity of resection margin is even more     highlighted as patients undergoing portal vein resection despite negativity of portal vein     invasion after regular pathological work-up show significantly better survival compared to     patients without portal vein resection. In sum, given the overall poor prognosis despite     tumor resection, auxiliary treatment strategies to improve long-term outcomes are desperately     needed. Over the last 5 years, irreversible electroporation (IRE) emerged as a non-thermal     ablative modality that allows local tumor destruction with sparing vital structures like     arteries, venous vessels, as well as the bile and pancreatic duct. There is increasing     evidence that IRE for locally unresectable pancreatic cancer is effective with an increase in     local progression free survival , distant progression free survival and overall survival     compared to historic controls.Data on margin accentuation IRE are sparse while in a recent     study published by Martin et al showed that margin accentuation among patients with     borderline resectable disease can be performed safe and efficacious if the treatment can be     performed with a high degree of technical ability and skill set.   "
25475|NCT02952222|"     The primary aim of this study is to compare the propofol requirements of children who receive     propofol with that of children who receive dexmedetomidine prior to propofol, for sedation     for upper and lower endoscopic procedures.   "
25427|NCT02952846|"     The study is a prospective interventional study with three main aims:        1. Describe the frequency and severity of withdrawal syndrome in a population of paediatric          intensive care patients.        2. Test whether implementation of an algorithm for tapering of analgosedation changes the          frequency and severity of withdrawal symptoms in the same population.        3. Investigate how the health care providers experience having to adhere to such an          algorithm.   "
25428|NCT02952833|"     This study is a study to evaluate the safety of ZPIV. Three dose levels may be evaluated. The     entire duration of each subject's participation is approximately 14 months including     recruitment and collection of data on the safety and reactogenicity of the study vaccine and     samples for the assessment of immunogenicity. This study is expected to take approximately 30     months to complete from initiation through availability of a final report on the primary     outcomes of safety and the secondary outcomes of humoral immunity to ZIKV. The Primary     objectives of this study are to 1. Assess the safety and reactogenicity of a homologous prime     boost regimen of ZPIV given at three different dose levels and 2. Compare the safety and     reactogenicity profile of ZPIV after each vaccination and between dosage groups.   "
25429|NCT02952820|"     The key objectives of this study are to determine, using sleep diaries, whether lemborexant     at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset,     subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia     disorder.   "
25430|NCT02952807|"     to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter     for induction of labor   "
25431|NCT02952794|"     To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic     mucosal band ligation (EMBL) for early cancer.   "
25432|NCT02952781|"     The purpose of this research is to test the clinical value of a new P-wave sensitive     recording vector compared to a standard ECG limb lead II vector from similar easy-to-use     long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring     (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the     electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM     system improves arrhythmia diagnosis.   "
25433|NCT02952768|"     Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to     have a role during resuscitation. The aims of this study were to develop a novel,     resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a     short curriculum and to assess the feasibility.      The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a     3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound;     and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and     searching the possible cause of cardiac arrest.      A half-day curriculum was designed, and comprised of one-hour didactics and 3-hour     small-group hand-on training. Assessments were performed, including a written test, the US     image acquisition and a satisfaction survey. From August 1, 2014 to March 31, 2016, the     multi-center emergency physicians who attended the US-C-A-B curricula were enrolled     prospectively.   "
25434|NCT02952755|"     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155     / DWC20156 and DWC20162 in Healthy Volunteers   "
25436|NCT02952729|"     This Phase 1b trial is an open label, multi-center study of XMT-1522 administered as an     intravenous infusion once every three weeks. The dose escalation part of the study will     establish the maximum tolerated dose or recommended Phase 2 dose for in patients with     advanced breast cancer and either a HER2 immunohistochemistry (IHC) score of at least 1+     using a validated IHC assay or with evidence of HER2 amplification. Patients with HER2     positive (by IHC or amplification) gastric cancer or nonsmall cell lung cancer may also be     eligible for participation in dose escalation. Upon completion of dose escalation, the cohort     expansion segment of the study will consist of four parallel cohorts of different patients     groups to confirm the maximum tolerated dose or the recommended Phase 2 dose and estimate the     objective response in each of the patient populations.   "
25437|NCT02952716|"     The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after     carbon monoxide poisoning   "
25438|NCT02952703|"     This study tests whether a smoking cessation intervention for pregnant women that extends     postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the     research environment that established its effectiveness (40% maintained biochemically     verified 6-month abstinence). The research aim is:      Is Striving to Quit more effective in achieving postpartum smoking cessation than First     Breath, the current standard of care for pregnant women in Wisconsin who smoke?      250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125)     will receive the existing First Breath prenatal intervention. Those in Group B (Striving to     Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home     visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls,     and up to an additional $100 in gift cards. The primary outcome will be biochemically     confirmed smoking cessation at 6-months postpartum.   "
25439|NCT02952690|"     The purpose of this study is to evaluate the feasibility of endotracheal intubation via     glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged     between 1 and 5 year old.   "
25440|NCT02952677|"     This is a multi-centered randomized controlled trial to investigate the effects of     Remind-to-Move (RTM) using wearable devices at home for promoting upper extremity recovery     in stroke patients after discharge from subacute hospitals.   "
25441|NCT02952664|"     This study will employ two monitoring device prototypes. The devices are sensors containing     accelerometers and gyroscope. The raw output data will be analyzed to determine when patients     are moved or are repositioned in their beds. The data is captured within a modem which will     correlate these movements with video recordings for interpretation by the research team. One     sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the     frame of the hospital bed. The investigators propose a non-blinded trial with n=10 where all     subjects will undergo the two devices. A video camera will be placed in each subject room for     recording the repositioning events to correlate the monitor signals with the actual subject     repositioning captured by the video. The goal of the trial is to validate the ability of each     of the sensor prototypes to accurately detect when subjects are turned, in order to reduce     stationary positioning which contributes to the incidence of pressure ulcers and to improve     compliance with patient repositioning trials.   "
25442|NCT02952651|"     The purpose of this study is to evaluate predictability of a respiratory variation in pulse     oximeter plethysmography for fluid responsiveness in children undergoing major surgery.   "
25443|NCT02952638|"     This study aims to test the hypothesis that dietary intake of phosphatidylcholine (PC) and     lysophosphatidylcholine (LPC) acutely alters plasma lysophosphatidic acid (LPA) levels and     autotaxin activity in normal weight and obese subjects.   "
25444|NCT02952625|"     This is a pilot non-intervention study that aims to introduce PET/MRI, a state of the art new     imaging technique, into the radiotherapy treatment pathway of patients with head and neck     cancer. Ultimately the investigators aim to establish appropriate scanning and image     registration protocols, to allow progression to a randomized trial of adaptive radiotherapy     dose escalation. The latter is thought to potentially improve outcomes in this group.      Ten patients with squamous cell carcinoma (SCC) of the oropharynx, hypopharynx and larynx,     planned for radical treatment with radiotherapy (+/-chemotherapy), will be recruited. Study     participants will have two PET/MRI scans, with the radiotherapy immobilization devices in     situ. The first will be done prior to the start of radiotherapy, the second half way through     treatment.      Image quality will be assessed by comparing to standard diagnostic scans and different     registration methods will be compared to establish the best way of incorporating PET/MR image     data into the radiotherapy planning system. Patient tolerability and workflow considerations     will also be qualitatively assessed. Furthermore, a planning study will be conducted to     establish relevant treatment protocols for a subsequent dose escalation trial.      PET/MRI is an exciting new technology with a lot of potential in the context of adaptive     radiotherapy dose escalation. Within this pilot study the investigators aim to address the     technical challenges of using it in this context prior to proceeding to a randomized trial.   "
25445|NCT02952612|"     Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this     tumor are not palpable and are identified either through pathologic examination or from     imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary     microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach.     The purpose of this study is to understand more about the characteristics of papillary     microcarcinoma, which has been known for the cancer slowly progression   "
25446|NCT02952599|"     According to current guidelines, duration of anticoagulant treatment after a venous     thromboembolic event varies from 3 months to indefinite treatment depending on the estimated     risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are     limited to a maximum treatment duration of 12 months.      Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic     recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality     and other drug related adverse events) of extended treatment with edoxaban up to 12 months in     an unselected patient population in routine clinical practice.   "
25447|NCT02952586|"     This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor     activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC     CRT alone in front-line treatment of patients with locally advanced head and neck cancer.   "
25449|NCT02952560|"     Difficulty in managing the airway is the single most important cause of major     anesthesia-related morbidity and mortality. The currently used clinical method of predicting     airway difficulty used by anesthetists is limited and not very highly sensitive or specific.     Any additional bedside method that increases its specificity and sensitivity would be     valuable. This project is designed to study and measure the tongue thickness and oral cavity     height by using an ultrasound scan and comparing them with the same measurements obtained by     CT scan. These will also be compared to a more complicated measurements used in previous     studies to investigate any correlation with the currently used clinical methods. This     information will help us decide if ultrasound may help Anesthesiologists assess difficulties     in airway management in a more accurate, precise and reliable simpler method.   "
25450|NCT02952547|"     The purpose of this study to Compare the safety and pharmacokinetics between     co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects   "
25451|NCT02952534|"     The purpose of this study is to determine how patients with metastatic castration-resistant     prostate cancer, and evidence of a homologous recombination gene deficiency, respond to     treatment with rucaparib.   "
25452|NCT02952521|"     This is a research study to look at differences in tumor tissue from ovarian cancer patients     that may help to determine response and resistance to treatments.   "
25454|NCT02952495|"     This proposed Phase 2 The Small Business Innovation Research study is a randomized trial of     the effectiveness of A Toast to Health in Later Life! a web-based patient educational     program designed to prevent hazardous and harmful drinking in older adults. The project's     specific objectives are to        1. provide reliable information on the extent to which A Toast to Health in Later Life!          reduces alcohol-related risks and problems among older patients who drink and        2. evaluate the extent to which these reductions are associated with increases in          health-related quality of life, patient knowledge and self-efficacy and decreases in the          use of health services and the costs of care.   "
25455|NCT02952482|"     To test if the routine newborn screening dried blood spots can be used to test if elevation     of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy     (ALD)   "
25456|NCT02952469|"     The purpose of this project is to collect initial data regarding biodistribution,     reproducibility, and dosimetry for the radiotracer Ga-68 PSMA-HBED-CC, an agent which may be     useful for the early detection of metastatic prostate cancer. Investigators will use a test     and re-test design in all patients to determine reproducibility of lesion detection and     signal intensity, and will include dynamic imaging in some patients for the purposes of     dosimetry. Patients with known metastatic prostate cancer will be recruited and imaged on two     occasions within the course of 15 days.   "
25457|NCT02952456|"     Rationale : Persons with epilepsy have a greater risk of incurring accidental injury and a     higher mortality risk than the general population.      The main objective of the study is to understand life experience of the disease or risks     associated with epilepsy in patients with epilepsy, relatives of patients and bereaved     families.      Study design: Qualitative study (study based on interviews) Population: Three groups will be     interviewed: bereaved families, patients with epilepsy and relatives of patient. Bereaved     family: relatives who contact the French sentinel network Réseau Sentinelle Mortalité     Epilepsie (RSME) notifying an epilepsy-related death (regardless the cause of the death and     the timeframe between death and interview). Patients with epilepsy: patients having a secure     diagnostic of epilepsy from 15 years old to 65 years old. Relatives of patients with     epilepsy: spouse/husband or parents invited by a patient with epilepsy to participate to the     interview who consent to participate.      Method: Semi structured in-depth interviews will be conducted by an experienced qualitative     psychologist in face to face, at home, at the hospital or at any other place (depending on     the choice of the participants). The interview topic guide will be centered on     participants'personal experience. Interviews will be digitally recorded and will be     transcribed by a secretary.      The results of this study will be integrated in educational therapeutic programs regarding     prevention of risks related to epilepsy.   "
25458|NCT02952443|"     The objective of this study is to evaluate a multi-component exercise intervention as an     effective therapy to reverse pre-frailty phenotype in females age 65 or older. Participants     will be screened for frailty phenotype using the Cardiac Health Study - Frailty Index (CHS);     the Clinical Frailty Scale (CFS); and a measure of self-paced normal walking speed.     Participants undergo baseline evaluation to determine frailty phenotype and then those     females who meet the pre-frailty criteria are randomized into one of two groups; 1)     Multi-component exercise program, or 2) A control group who receives a monthly newsletter on     tips for successful aging. The exercise group will participate in multi-component exercise     program which will emphasize resistance training but also include aerobic, balance and     flexibility components 3 times a week at 45 to 60 minutes/session for 16 consecutive weeks.     The control group will be asked to maintain normal daily-living habits for the duration of     the 16-week study.   "
25459|NCT02952430|"     Patients aged over 65 comprise more than half the emergency general surgical workload,     however, available risk-prediction tools for such patients are extrapolated from younger     cohorts. Research suggests that high pre-operative frailty scores correlate with increased     post-operative mortality and morbidity. Validated frailty assessments may help identify high     risk older emergency surgical patients, facilitating decision-making and informing patient     choice.      We propose the first prospective UK observational study assessing frailty as an independent     predictor of outcome in the older surgical patient undergoing emergency laparotomy.      Prospective data collection of patients over 65 undergoing emergency laparotomy will be     performed in 20 NHS Trusts. Pre-operative frailty scores will be evaluated using the Rockwood     Frailty Scale. Primary outcome measure is 30-day mortality. Secondary outcome measures are     post-operative complications, altered independence status and length of stay.      Results will be disseminated at national/international surgical meetings and published in a     peer-reviewed journal.   "
25552|NCT02951221|"     The primary objectives of the study are to assess the relative bioavailability of the BIIB074     direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and     to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF.     The secondary objective of the study is to assess the safety and tolerability of BIIB074     administered as the DCF following single oral dose administration in healthy participants.   "
25460|NCT02952417|"     The aim of this study was to estimate the impact of sex on relative survival and excess     mortality following acute myocardial infarction (AMI) using a population-based cohort within     a relative survival framework. Patient-level data concerning demographics, co-morbidity,     cardiovascular risk factors and treatments at discharge were extracted from the Swedish     Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated     According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for     patients hospitalized with acute coronary syndrome. Patients were followed-up for their vital     status after AMI hospitalisation, with censoring at the end of follow-up on the 31st of     December, 2013.   "
25461|NCT02952404|"     This is a retrospective cohort study. This two cohort study seeks to compare the incidence of     obstetric anal sphincter injuries (OASIS) in two time periods, before and after an     educational workshop for improved perineal support.   "
25476|NCT02952209|"     This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth     extraction compared to extraction alone in the posterior maxilla. The results of this study     will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post     extraction in the posterior maxilla region.   "
25487|NCT02952066|"     The purpose of this study is to measure the density of a temperature-sensitive protein, named     TRPV1, in the airway mucosa tissue of both non-asthmatic and moderate to severe persistent     asthmatic patients. This study may generate information for developing new therapeutic     strategy.   "
25557|NCT02951156|"     Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase     1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents     for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).   "
25462|NCT02952391|"     Although PD is considered predominantly as a motor disease caused by loss of dopaminergic     neurons, multiple studies indicate that cholinergic dysfunction already starts in early PD     and is crucial for the development of dementia in addition to motor symptoms.Because of its     crucial role in CNS functioning and neurodegenerative disorders, including PD, it is of great     importance to get a better understanding of the cholinergic functioning in the brain.     Pathways of acetylcholine synthesis, transport and release provide possible targets for in     vivo imaging of the cholinergic system. However,previous approaches are considered as     indirect biomarkers of cholinergic terminal integrity because they measure both pre- and     post-synaptic expressions. The novel vesicular acetylcholine transporter (VAChT) tracer     [18F]Fluoroethoxy-Benzovesamicol ([18F]FEOBV) provides a more direct measurement of     presynaptic cholinergic function. The use of [18F]FEOBV as a Positron Emission Tomography     (PET) imaging marker of cholinergic innervations has, however, only been studied in healthy     human volunteers and no data is available on patients.      With this study the differences in cholinergic function between PD patients and healthy     aged-matched volunteers will be quantified. In addition the test-retest variability will be     determined   "
25463|NCT02952378|"     Treatment with colloidal solutions has during long time been a cornerstone within intensive     care. Lately, doubts have been raised about synthetic colloids, and the natural albumin has     been used more and more.      One of these solutions is the hyperoncotic Albumin 20%. However there are still many     aspects of the physiological effects of hyperoncotic albumin, that are not known. In this     study physiological effects will be studied in burn patients and healthy subjects. The     colloid osmotic pressure and the increase of the plasma volume will be measured in 15 healthy     subjects and in 15 burn patients. The effect on the plasma volume will be studied using     hemoglobin as a marker of dilution. Colloids osmotic pressure and albumin concentration will     be measured directly and urin production will also be measured. Blood samples will be     collected during 4 to 5 hours to achieve a profile over the changes.   "
25464|NCT02952365|"     The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent     epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery   "
25465|NCT02952352|"     To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the     Colville reservation through a community-based, culturally informed intervention, the study     specifically aims to: 1. conduct focus groups and interviews with adult members of Colville     tribe to inform the adaptation, manualization and implementation of a culturally informed     diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness     of a community-based, culturally informed diabetes prevention intervention by assessing     between group changes in: Primary Outcomes: weight, dietary fat and caloric intake, vegetable     consumption, and physical activity; Secondary Outcomes: physical fitness, blood pressure,     lipids, self-reported quality of life; and, 3. evaluate the sustainability of the diabetes     prevention intervention by assessing participant perceptions of program component fit through     focus group discussions with participants in the intervention and telephone interviews with     those who left the program.   "
25466|NCT02952339|"     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in     RSV-seronegative infants 6 to 24 months of age.      This study is a companion study to IMPAACT 2011.   "
25467|NCT02952326|"     Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final     irrigation protocol on necrotic mandibular premolars.   "
25468|NCT02952313|"     This study is being conducted to obtain outcomes data in subjects with severe to extreme     class NOSE scores undergoing placement of the Spirox Latera Implant with or without     concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.   "
25482|NCT02952131|"     Inflammatory Bowel Disease (IBD) is a group of inflammatory conditions of the small bowel and     colon. Main types include Ulcerative Colitis and Crohn's Disease. Symptoms are often     difficult to distinguish except for location and nature of changes. IBD complex arises with     interaction of environmental, genetic factors, immunological responses, and chronic and     recurring inflammation.      Many factor appear as contributory, but no single set of issues appear to explain the     process. Microbiota, intestinal wall granulation or breach, dietary, genetic predisposition     all appear to factors. Treatment is often reactive or suppressive medications, neither of     which appears to reverse the disease processes. This study explores the value of a complex     group of adipose-derived stem/stromal cells (AD-cSVF) in the disease process.   "
25469|NCT02952300|"     the aim in this prospective in vivo randomized clinical trial to evaluate the influence of     instrumentation technique ( reciprocation single file (wave one ) versus rotation single file     (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic     treatment in single rooted lower premolars with symptomatic irreversible pulpits.      According to the inclusion criteria the patients enrolled in the study and allocated randomly     into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is     done at single visit. firstly the patient's medical and dental history is taken .the patient     assign on informed consent. and then,anaesthetized and access cavity performed and root canal     preparation is done by either two systems and then irrigation and obturation is done. the     patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator     will recall the patient to check the records and follow up the patient.   "
25470|NCT02952287|"     The purpose of our study is to validate the accuracy of 4D PC flow method in quantification     of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D     PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR     with 2D PC flow measurement.   "
25471|NCT02952274|"     The aim of this study is to compare the ball attachment to the locator attachment regarding     the OHRQoL (oral health related quality of life) for completely edentulous patients retaining     a mandibular overdenture with a midline placed implant   "
25472|NCT02952261|"     The purpose of this study is to explore the effectiveness of 3D printing in small pulmonary     nodule localization by the design of an assisted device to facilitate the localization     procedure.   "
25473|NCT02952248|"     The main objective of the dose-escalation part of the trial is to determine the safety and     tolerability, Pharmacokinetic (PK), biomarkers, and efficacy, and to determine the Maximum     Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of     patients with dose-limiting toxicities (DLTs) in patients with selected advanced solid     malignancies. Safety and tolerability will be evaluated by monitoring the occurrence of     adverse events (AEs), serious AEs (SAE), and laboratory parameter abnormalities, as well as     changes to vital signs.      Secondary objectives are the determination of the PK profile of BI 754091 after single and     multiple doses of BI 754091, and the preliminary assessment of antitumour activity.      In the dose-expansion part of the trial, the main objectives are to further assess the     safety, efficacy, PK profile, and biomarkers of BI 754091 at the RP2D.   "
25474|NCT02952235|"     Use of two high SPF sunscreens under actual use conditions.   "
25477|NCT02952196|"     Addiction to amphetamine is characterized by alternating phases of intoxication and short     abstinence, followed by recurrent drug-craving episodes which result in distress and relapse.     Addiction involves a number of neurotransmission systems, including the endocannabinoid     system (ECBS). Cannabidiol (CBD), the second most abundant component of cannabis, is known     for its broad spectrum of physiological, anxiolytic and neuroprotective properties. It has     been shown to have multiple therapeutic properties for treating anxiety, schizophrenia and     interestingly CBD has been shown to be potentially helpful in treating addiction, due to its     effects on various neuronal circuits involved in this disorder.      The investigators overall hypothesis is that CBD is an interesting pharmacological contender     to decrease amphetamine craving and treat amphetamine addiction.   "
25478|NCT02952183|"     Although nerve-sparing surgery has been introduced for female patients with the pelvic     tumors, its success rate depends on operators. To achieve consistency of surgical procedure,     It is necessary to adopt pelvic autonomic nerve monitoring technique.      The Aims of this study is        1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic          system.        2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I        3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)   "
25479|NCT02952170|"     This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver     disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic     risk.   "
25480|NCT02952157|"     Postoperative sore throat is a complication after general anesthesia requiring endotracheal     intubation. The investigators will evaluate the efficacy of lidocaine jelly application on     the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.   "
25481|NCT02952144|"     Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD).     Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M is     produced by most cells in the body and is metabolized in the kidney in healthy individuals.     However, in HD patients with renal dysfunction, β2M which is not removed entirely by HD     accumulates excessively in the blood. Then it forms amyloid fibrils that are deposited in     bones, joints, and soft tissues. The fibrils are further modified by advanced glycation end     products (AGE), inducing local macrophage infiltration and production of cytokines leading to     chronic inflammation and activation of osteoclasts. Consequently, severe complications with     various symptoms are developed, which are collectively referred to as DRA.      Lixelle® is a whole-blood β2M apheresis column developed to adsorb and eliminate β2M     selectively from the blood of DRA patients. The treatment is performed with Lixelle®     connected upstream of the dialyzer in series on a HD circuit in every session. The Lixelle®     column contains porous cellulose beads with covalently linked hexadecyl alkyl chain ligands,     which selectively adsorb β2M, via a molecular sieving effect because of its porous structure     and hydrophobic interaction with ligands. Lixelle® has been used to relieve symptoms and     prevent the progression of DRA in Japan since 1996, when health insurance coverage and     reimbursement for the treatment were approved by Japanese Ministry of Health, Labor, and     Welfare. Improvement of the activities of daily living (ADL) and remission of arthralgia by     Lixelle® treatment has been shown in several clinical studies.   "
25508|NCT02951793|"     Investigators are seeking to determine the impact of recent alcohol, smoking or psychotropic     drug use prior to intensive care unit (ICU) admission on incidence of delirium and sedation     requirements.      Study design: A prospective observational study, in a medical ICU of a tertiary university     hospital.      Methods: For all new ICU admissions, a 1-page questionnaire including Alcohol Use Disorders     Identification Test (AUDIT-C), smoking history and prior medication use was given to the     patient or closest family members.      Delirium was assessed by trained ICU nurses using Intensive Care Delirium Screening Checklist     and Richmond Agitation-Sedation Scale.   "
25483|NCT02952118|"     This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from     snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard     diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour).     Patients with no OSA over the last year will sign an informed consent after receiving     explanations from authorized physician (Professor Asher Tal). The patient will than undergo a     sleep study using a mobile device PAT (Peripheral Arterial Tomography, Itamar Medical,     Israel) ,an approved device in Israel, USA and many other European countries,, approved for     use by the USA FDA). This sleep study is needed in order to rule out OSA, namely AHI of more     than 15 events per hour of sleep.      The study duration with each patient will be 48 hours (two nights); at the first night the     sleep study will be with PAT device, with snoring recording and without the Forrest epic     device. In the second night the sleep study will be with PAT device, with snoring recording     and with the Forrest epic device. The order of the sleep studies (with and without the epic     device) will be randomly determined by computerized ahead prepared list. The research     duration for patients that did not have a sleep study over the last year, will take place for     3 nights; the sleep study will be performed in order to make sure the patient does not suffer     from obstructive respiratory disorder during sleep. The sleep studies will take place in a     sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home.      Recordings over the nights with or without the Forrest epic device will be carried out at     the patient's home, after verification that each patient sleeps alone in his/her room. The     recording and data processing of snoring will be performed through the application SNORLAB     on IPHONE 6 mobile device. Ambulatory sleep studies with PAT device will be carried out     during two nights (with and without the Forrest Device) with most patients.      During the examination, respiratory index will be tested such as: obstructive respiratory     events during sleep, oxygen saturation in blood at rest (measured non-invasively) during     sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of     oxygen saturation in blood.   "
25484|NCT02952105|"     It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation     early. At the same time Research findings have identified high-quality CPR with minimum     interruption is critical to the success of defibrillation therapy. Both the guidelines by     American Heart Association and the guidelines by European Resuscitation Council emphasize the     importance of minimizing interruptions in chest compressions, specifically, duration of the     pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of VF     during chest compression, which has high sensitivity and specificity. And the investigators     can identify VF and defibrillate earlier.      The aim of this study is to verify that if Sherlock algorithm of Philips MRx     monitor/defibrillator can identify shockable rhythms during chest compression accurately.   "
25485|NCT02952092|"     The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to     darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.   "
25486|NCT02952079|"     The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better     option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.   "
25488|NCT02952053|"     The main objective of this study is to assess effects of Dry Needling into Myofascial Trigger     Point compared Dry Needling into Taut Band point based on the outcomes of myotnometric     measurement in healthy subjects.      Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the     soleus muscle will achieve changes in myotonometric measures compared to Deep Dry Needling of     the Taut Band of the soleus muscle.   "
25489|NCT02952040|"     The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the     pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.   "
25490|NCT02952027|"     Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare     expenses. The goal of perioperative respiratory therapy is to improve airway clearance,     increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously     used to prevent atelectasis and PPCs—implementation of which requires substantial provider     time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness     of ISs is unclear due to poor patient compliance in past studies.      The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical     outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be     improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of     the more compliant IS users vs. the less-compliant IS users.   "
25491|NCT02952014|"     The purpose of this study is to examine the acute effects of a pre-workout dietary supplement     on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.   "
25492|NCT02952001|"     The purpose of this study is to characterize the continued clinical benefit(s) regarding     safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide     injectable suspension, for the treatment of macular edema associated with non-infectious     uveitis. This study will be a non-interventional extension of the Parent study, CLS1001-301.   "
25493|NCT02951988|"     This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams     (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive     treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in     participants with Major Depressive Disorder (MDD).   "
25494|NCT02951975|"     This observational study will evaluate the safety, efficacy, characteristics of patients,     characteristics of physicians and quality of life in patients who are prescribed OZURDEX® as     treatment for non-infectious uveitis of the posterior segment of the eye in France.   "
25495|NCT02951962|"     This is a phase 1, open label, two-cohort, single-sequence, crossover study   "
25496|NCT02951949|"     One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk     actors including clinical features, serum biochemical parameters, single nucleotide     polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness     (92 women) and coronary computed tomography (32 women). MANOVA analysis confirmed that both     age and estradiol level behaved as independent variables associated with IMT. Findings at the     coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen     stenosis were sporadic and did not allow for establishing association with any of the     variables assessed.   "
25497|NCT02951936|"     Chronically ventilated patients will be hemodynamically measured by bioimpedance (NiCAS by NI     medical ltd.) for cardiac output, Total peripheral resistance and other NICAS derived     parameters.      Patients fluid balance will be planned according to these parameters and the rate of     liberation from ventilator and rate of worsening renal function will be measured   "
25509|NCT02951780|"     The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and     what effects LY3185643 and rGlucagon have on the body. This study will also help to determine     if LY3185643 is safe and well-tolerated.      This study will last at least 35 days, not including screening.   "
27399|NCT02927106|"     In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity     assays will be utilized to define clinically relevant gene mutations and identify potential     therapeutics for patients with acute myeloid leukemia (AML).   "
25498|NCT02951923|"     Bovine colostrum is the milk produced by cows immediately after calving. It contains high     levels of proteins that improve immune protection and may act to prevent colds. During     intense training, athletes often have compromised immune function. This may be especially     true in club-level rugby players who abruptly start high intensity training in the spring in     preparation for their competitive season. Our study will assess the effects of supplementing     these players with bovine colostrum during this intense training. Thirty-six players will be     recruited; half will consume colostrum during the 8 weeks of early-season training and half     soy protein. The investigators predict the bovine colostrum supplement will improve health     during the training and increase fitness levels.   "
25499|NCT02951910|"     Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can     already be found in several artificial tears recommended to alleviate symptoms of dry eye. A     recent hyaluronate modification involves zinc-hyaluronate complex formation by adding     zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular     structure, which functions as both a mechanical barrier and a biocompatible film on the     ocular surface. Apart from its beneficial elastoviscous characteristics, previous results     indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor     endings underlying pain. Although hyaluronate is widely used in artificial tears to improve     tear film stability, its effect on ocular surface sensitivity was not evaluated in patients     with dry eye. The aim of this study is to investigate the characteristics of ocular surface     sensations and corneal sensitivity in dry eye patients before and after long-term tear     supplementation with zinc-hyaluronate.   "
25500|NCT02951897|"     In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases,     83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC     patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical     treatment, will have a relapse or progression.      Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or     lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far,     CTCs-detection technologies can be divided into epithelial cell adhesion molecule     (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and     EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators     used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung     Adenocarcinoma cases.      The investigator aim to explore whether CTCs detection prior to surgery can be contributive     to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy     of early stage lung Adenocarcinoma.   "
25501|NCT02951884|"     This study will evaluate pain level experienced by patients who have a break of the top of     their shinbone and have either blood removed from the joint alone or have blood removed and     medicine injected into the joint.   "
25502|NCT02951871|"     Background.Although the life expectancy of patients with FL has recently increased, notably     since the introduction of rituximab in combination with chemotherapy, little is known     regarding the precise causes of patients death. Patients and methods'. This study describes     the different causes of death in FL patients among followed since 2000 at Lyon University     Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as     related to lymphoma progression, treatment-related toxicity (including TRM and secondary     myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.   "
25503|NCT02951858|"     The purpose of this research is to improve the ability of primary medical staffs in screening     and intervention for alcohol, benzodiazepines, and other illicit drug use.   "
25504|NCT02951845|"     The purpose of the study is to assess the oral bioavailability of the two tablet formulations     of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a     high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.   "
25505|NCT02951832|"     The investigators are going to select the normal child-bearing period women as the study     subjects and draw their peripheral blood to observe and analyze the change of quantity and     percentage of lymphocyte subsets along with the change of menstrual cycle.      Recording their BMI\menstrual history\and childbearing history, the investigators would     select 300 healthy women in 6 different age groups which are aged 20-24, aged 25-29, aged     30-34, aged35-39, aged 40-44 and aged 45-49, then draw 1-2 ml blood form their peripheral     vein (adding EDTA for anti-coagulation). The investigators are going to perform routine     examination on the blood samples and detect T\B\NK lymphocyte through flow cytometry (FCM),     thus calculating the absolute number of every species of lymphocyte. The investigators make     assessment for the cellular immune function of the women during child-bearing period via     comparing distinction in percentage and absolute number of every lymphocyte subset among     reproductive-age women in different ages.   "
25506|NCT02951819|"     The purpose of this study is to evaluate complete response plus (+) very good partial     response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination     with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated     subjects, and in relapsed subjects with multiple myeloma, as defined by the International     Myeloma Working Group (IMWG) criteria.   "
25507|NCT02951806|"     Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids.     Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in     postpartum patients and 69% in non-pregnant patients including males and females (1). Some     researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and     effective way to reduce the incidence and severity of hypotension during cesarean section     under spinal anesthesia (2). In this new research I want to investigate the effect of slow     injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence     of itching In this double blind randomized study two hundred parturient will be randomly     allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution     with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All     parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will     be those with allergy to any medications, contraindications to spinal anesthesia, those who     requested sedation, presence of skin lesions that may cause itching and opioid addiction.      Parturient will be monitored regarding the incidence of itching, hypotension, nausea and     vomiting. Onset and level of sensory block will also be recorded.   "
25510|NCT02951767|"     This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment     in participants with locally advanced or metastatic urothelial bladder cancer. Participants     will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants     who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will     contain participants who have progressed during or following a prior platinum-based     chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652).     Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of     atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue     until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1     (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue     until loss of clinical benefit or unmanageable toxicity.   "
25511|NCT02951754|"     Methylphenidate (MPH) is the first-line pharmacological treatment for adults with     Attention-Deficit/Hyperactivity Disorder (ADHD). Nevertheless, there is considerable     interindividual variability regarding the dose required, tolerability and response rates to     MPH. The aim of this study is to address the clinical and genetic predictors of MPH treatment     outcomes in ADHD.   "
25512|NCT02951741|"     Revision total hip replacement arthroplasty is a surgery having intra- and postoperative     substantial blood loss. The investigators will investigate the relationship between the     various hematologic variables and postoperative bleeding volume.   "
25513|NCT02951728|"     This is a Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma   "
25514|NCT02951715|"     Twenty patients with tinnitus and a typical noise-induced hearing loss (NIHL) audiogram were     included. Each subject underwent an otoscopic examination, distortion product otoacoustic     emissions, tinnitus-match testing, Tinnitus Handicap Inventory (THI) and serum zinc level     analyses. After 2 months of treatment with zinc, all tests were repeated.   "
25516|NCT02951689|"     Purpose: To evaluate the influence of probiotic supplementation on body composition and other     markers of health in occupational shift-workers.      Participants: Healthy, overweight females (ages 22-55 yrs) who are employed on a     shift-working schedule.      Procedures (methods): In a randomized, placebo-controlled intervention, subjects will     complete 3 different testing sessions (pre-screening, 1 baseline, 1 post-testing session) as     well as a 6-week intervention period. Prescreening will include written informed consent, a     health history questionnaire, baseline anthropometric measures, assessment of resting heart     rate, and exercise protocol familiarization. Baseline testing will involve body composition,     a fasted blood draw, mood surveys, and an exercise treadmill test. Subjects will be     randomized to a treatment group (multi-strain probiotic or placebo) for 6 weeks of     supplementation that includes 2 electronic contacts, followed by post-testing that will occur     in the same fashion as baseline testing.   "
25517|NCT02951676|"     This is a prospective, longitudinal, observational, cohort study investigating young adults     undergoing surgical extraction of a wisdom tooth with and without antibiotics     post-operatively. The prescription of antibiotics will be based on clinical judgment based on     case complexity, trauma and length of procedure. No randomization will be performed. Saliva     will be collected at seven observational time points ( Baseline, one week ,two weeks, three     weeks , one month,three months and six months.) and Supragingival plaque samples will be     collected at four observational time points ( Baseline , one week , one month, and 3 months)     .A control group of 15 subjects who do not undergo dental extractions or antibiotic treatment     will be recruited after obtaining informed consent and will be followed up for the same seven     time points..Routine standard care will be observed. No new medications are triedThe samples     will be analysed for identification of bacterial genes using 16 S r RNA gene sequecing and     QPCR for change in the antibiotic resistance genes overtime. Kindly note that in the current     study the participants are patients who are already scheduled to undergo tooth extractions     with or without antibiotic treatment based on clinical judgement by the clinician performing     the extraction. ( These patients are on the waiting list for third molar extractions in the     dental hospital concerned.)      The participants will receive the intervention( Third molar extraction with /without     antibiotics) in the same manner and intensity even if they are not enrolled for the study.   "
25518|NCT02951663|"     Purpose: To evaluate adherence, tolerability, and total protein intake in bariatric surgery     patients provided with ready-to-drink protein supplements, and to evaluate the effects of     supplementation on body composition, metabolism, and health outcomes.      Participants: Patients scheduled to under go bariatric surgery aged 18-70 years old.     Participants will be included if they agree to comply with the study protocol, are free of     medical conditions that may contraindicate participation, and do not plan to become pregnant     during the study.      Procedures (methods): Participants will complete five laboratory visits for the current study     (pre-screening (visit 1), baseline testing (visit 2), and return visits at 3 weeks (visit 3),     12 weeks (visit 4), and 24 weeks (visit 5) post-surgery). The treatment group will be given a     12 week supply of a high protein, low-carbohydrate, low-fat supplement to be taken once daily     during days 3-7 post-surgery, and twice daily weeks 2-12. The treatment group will follow     standard of care recommendations put forth by the physician-nutritionist team, but using the     provided protein supplement to meet recommendations. The control group will be asked to     follow the standard of care recommendations from the physician-nutritionist team.      The primary study endpoints will be adherence, tolerability, and total protein intake in     bariatric surgery patients provided with a 12-week supply of ready-to-drink protein     supplements. Secondary outcomes will evaluate the effect of a protein supplement on body     composition (lean mass, fat mass, percent body fat, visceral fat, muscle thickness), resting     metabolic rate, clinical and endocrine blood values, functional fitness, and responses to     questionnaires evaluating mood, satiety, functional independence, and health related quality     of life.   "
25519|NCT02951650|"     This will be an open label multicenter study of the safety and efficacy of an active     implantable VNS device in patients with Crohn's Disease.   "
25520|NCT02951637|"     The purpose of this study is to compare chemotherapy and gefitinib in combination with     gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.   "
25521|NCT02951624|"     The primary aim of this study is to investigate the acute effect of the frequency and     duration of breaks in sitting time on the metabolic risk factor profile.   "
25522|NCT02951611|"     60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective     video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30     patients in each group: 1. control group and 2. treatment group. Patients in treatment group     will receive transcutaneous electrical acupoint stimulation(TEAS) during the surgery and at     6h and 24h after surgery. Patients in the control group received only TIVA general anesthesia     and sham electrical stimulation. Serum from patients of both groups will be collected at     before surgery, 1h and 25h after surgery, respectively. Serum levels of TNF-alpha, IL-1 beta,     CXCL8, IFN gamma and IL-4 at different time points will be measured and compared between the     two groups.   "
25523|NCT02951598|"     The purpose of this study is to learn about health care use, costs, and clinical outcomes     over time for amyloid positive participants with early stages of AD in the United States.     This study is for research purposes only, and is not intended to treat any medical condition.     No study therapy(ies) for AD will be administered.   "
25533|NCT02951468|"     Background Treatment of clavicular non- and malunion is still challenging. Current surgical     procedures often result in partially frustrating functional outcome along with high-grade     subjective impairment and increased rates of revision surgery. However, the combination of     vital bone graft and a biomechanically sufficient fixation system seems to be a promising     concept of treatment.      Methods In this retrospective study, 14 patients with a mean age of 44 years (26-67 years)     suffering from non-union (n=11) and/or malunion (n=4) of the clavicle were enrolled. All     patients were surgically treated using an anatomical precontoured locking compression plate     (LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age-     and sex-specific relative Constant Score.   "
25582|NCT02950831|"     The purpose of this study is to assess feasibility of using wearable sensors to capture     objective assessments of patient's activity and sleep quality during the spinal cord     stimulation (SCS) treatment continuum.   "
25524|NCT02951585|"     Intra-articular hyaluronic acid injections, also known as viscosupplementation, are a     treatment option for knee osteoarthritis that serves to restore the decreasing rheological     properties of synovial fluid. KARTILAGE® CROSS is a visco-elastic gel of highly purified     reticulated hyaluronic acid. It contains mannitol to provide an anti-oxidative action and to     avoid hyaluronic acid depolymerization. Reticulation and mannitol increase the residency time     of the product in the joint cavity then allowing a single injection in painful knee     osteoarthritis patients.      The US food and drugs administration (FDA) and European medicine agency (EMA), have recently     published guidelines recommending a higher level of integration of biomarkers in the     development and testing of new drugs to advance decision-making on dosing, time and treatment     effect, trial design, and risk/benefit analysis. Biomarkers can be used not only in the     process of drug development, but also in the future in assessment of individual patient's     response to treatment.      Several soluble biomarkers have been identified as potential candidates to predict or monitor     the efficacy of intervention. Coll2-1, a degradation product of type II collagen, and     Coll2-1NO2, a nitrated form of the Coll2-1 peptide have been studied in human osteoarthritis     and entered the qualification process. Evidences demonstrated them to be pertinent and to be     foresee as markers used for the diagnosis, the prognosis, the burden of disease and the     monitoring of a treatment efficacy.      The aim of this study was to provide with the first kinetic data regarding biomarkers in     painful knee osteoarthritis patients treated with a new reticulated hyaluronic acid. The     effects of the treatment were compared to those of saline solution. The primary endpoint was     a specific osteoarthritis biomarker, Coll2-1. The secondary endpoints were the effects of the     treatment or placebo on other biomarkers of osteoarthritis, its clinical efficacy and     tolerance   "
25525|NCT02951572|"     As fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation in     patients with neuromuscular disorders and thoracic deformations, we hope, by starting     non-invasive ventilation and improving these symptoms, to increase their physical activity.   "
25526|NCT02951559|"     Encephalopathies are a group of central nervous system (CNS) affection with heterogeneous     etiology. Several causes have been recognized including neurodegenerative, vascular,     infectious, autoimmune, toxic or allergic affections or secondary to systemic disorders.     While 30-50% of acute encephalitis remains without etiological definition, definitive     criteria for neurodegenerative diseases are usually unavailable in vivo and possible or     probable definitions are used. The Olfactory mucosa (OM) is the part of the nasal mucosa that     carries the specialized sensory organ for the modality of smell; the olfactory epithelium is     composed of five principal cell types including olfactory receptor neurons. A sample of OM     may be collected through a rhinoscopy-guided brushing: it is well-accepted by patients,     not-contraindicated in patients with raised intracranial pressure and associated with almost     no side-effects. Nasal brushing has recently been proposed for the in vivo diagnosis of     Creutzfeldt-Jakob disease (CJD).      Aims of the project are:        1. Training of ear throat and nose (ETN), Infectious disease (ID) and neurology (NEU)          specialists in the technique of nasal brushing;        2. Conducting a prospective study comparing the use of nasal brushing with gold-standard          criteria in the diagnosis of Encephalopathies;        3. Increasing the diagnostic and prognostic power in the diagnosis of encephalopathies.      A prospective, case control, multicentric study enrolling 400 patients and 100 controls     (patients with nasal stenosis undergoing rhinoscopy for clinical reasons). Patients will be     diagnosed and followed according to international guidelines and local clinical practice.     Cerebrospinal fluid and magnetic resonance imaging will be used, where indicated, for the     diagnosis according to the clinical or radiological suspect.   "
25527|NCT02951546|"     Nonalcoholic fatty liver disease (NAFLD) is frequently associated with obesity. NAFLD genetic     susceptibility involves Patatin Like Phospholipase Domain Containing 3 (PNPLA3) rs738409 and     Transmembrane 6 Superfamily Member 2 (TM6SF2) rs58542926 polymorphisms.      To date, biochemical mechanisms that affect the metabolic flexibility in obese NAFLD     subjects, in presence or absence of genetic susceptibility, need to be better clarified.      Different studies demonstrated that a dietary intervention, accompanied by a physical     personalized training, significantly reduce either the hepatic fat content either insulin     resistance in overweight and obese subjects, independently of weight loss.      On these bases, the aim of the study is to evaluate metabolic flexibility in obese NAFLD     subjects taking in account their genetics (presence or absence of PNPLA3 and TM6SF2     polymorphisms) and the histopathological diagnosis of either simple steatosis or nonalcoholic     steatohepatitis (NASH). In addition, the composition of gut microbiota will be evaluated.      Finally, in this study, two distinct healthy dietary profiles accompanied by a personalized     physical training, will be tested in order to comprehend whether and how healthy diets     could be effective not only in the prevention, but also in the clinical treatment of NAFLD     and other related conditions.   "
25528|NCT02951533|"     The purpose of the study is to compare the efficacy of Guselkumab with commercially available     active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants     with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.   "
25531|NCT02951494|"     The AlterG®-anti-gravity treadmill provides lower body weight support which enables     individuals to exercise without feeling their full body weight. How this body weight support     influences cardiovascular, respiratory, vascular and metabolic parameters is currently     unclear. Further, whether body weight support influences the trainability in response to     moderate continuous exercise is unknown. This investigation has two main goals. First, we     explore the direct influence of lower body weight support on cardiometabolic parameters     during maximal exercise testing. Second, we aim to compare changes in cardiorespiratory     fitness in response to a structured exercise protocol using moderate intensity with and     without lower body weight support.   "
25532|NCT02951481|"     The purpose of this study is to determine whether a bundle of measures specifically designed     for patients with ICD and applied by and Infectious Diseases expert during a year period     (2017) will improve the prognosis and reduce the rate of recurrence, compared with the     baseline phase (2015) in which no intervention was made.   "
25555|NCT02951182|"     This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group,     multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and     triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with     cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane     conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous for the F508del     mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA     therapy (F508del/MF).   "
25534|NCT02951455|"     The current project seeks to implement the Multiphase Optimization Strategy (MOST) and     Community Based Participatory Research (CBPR) principles to identify the most efficient,     scalable, and sustainable combination of Community Wise components. Community Wise is a     manualized multi-level intervention aimed at reducing health inequalities related to alcohol     and illicit drug use (AIDU).This 2x2x2x2 factorial design will be fully powered to detect     change in AIDU in a sample of 528 men with substance use disorders and a history of     incarceration residing in distressed communities with predominantly Black populations.     Participants will be randomly assigned to one of sixteen experimental conditions.   "
25535|NCT02951442|"     The primary objective is to show that the contribution of Klotho by the renal graft is an     independent determinant of the evolution of the recipient's central arterial stiffness during     the first year of renal transplant. The contribution of Klotho by the graft will be estimated     by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by     the circulating concentrations of FGF23. The recipient's central arterial stiffness will be     estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference     method for measuring aortic stiffness in human.   "
25536|NCT02951429|"     This Phase IIb, randomized, placebo-controlled, multicenter, international study will     evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone     (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of     Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated     tolerability. Participants will be randomized to receive 1 year of treatment with either oral     sildenafil or matching placebo while continuing to take pirfenidone.   "
25537|NCT02951416|"     Born out of the European Union 7th Framework Programme funded project European IPF Network     (eurIPFnet), the European IPF Registry (eurIPFreg) has become Europe's leading database of     longitudinal data from IPF patients, including control groups of patients with other lung     diseases. The registry was initiated with the intention of creating a permanent and     continuously growing record of well defined data on IPF in Europe, in order to increase the     chances of finding better treatment options for this devastating disease.      Clinical colleagues who would like to actively participate (both in terms of patient     recruitment and data analysis) are invited to contact us     (http://www.pulmonary-fibrosis.net/).   "
25538|NCT02951403|"     The study is a prospective case controlled clinical trial. The purpose of the study is to     investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow     when compared to conservative treatment.   "
25539|NCT02951390|"     Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which     might occur despite a regular follow-up. Despite low evidence, high-definition technology     (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch     syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority     study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our     hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under     expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection     rate in patients with Lynch syndrome.   "
25540|NCT02951377|"     Aim 1: The primary aim of this study is to test the feasibility of Mechanical Diagnosis and     Treatment (MDT) +/- transforaminal epidural steroid injections (TESI) on pain and disability     in patients awaiting physiatry consult for lumbar radiculopathy secondary to lumbar disc     herniation, compared to usual care within the current healthcare system in Calgary, Alberta,     Canada.      Hypothesis: the investigators hypothesise that centralisers treated with MDT and     non-centralisers receiving TESIs + MDT will have demonstrate reductions in self-reported pain     and disability, compared to usual care controls.      Aim 2: the investigators will also describe the potential impact on healthcare resources by     tracking surgical rates and self-reported healthcare utilisation during the study period.      Hypothesis: based on predicted reductions in pain and disability, the investigators     hypothesise that there will be a trend toward overall less healthcare utilisation (including     surgery) in the MDT guided group compared to the surgical wait list group.   "
25541|NCT02951364|"     The primary objective of this post-marketing surveillance study is to collect and assess data     related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF))     treatment regimen, per the approved Korea prescribing information for Harvoni, in routine     clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety     (MFDS). Patients will be treated as part of routine practice at Korean healthcare centers by     accredited physicians.   "
25604|NCT02950545|"     It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact     lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may     experience blur while driving. The purpose of this study is to determine if correcting small     amounts of astigmatism with contact lenses will improve driving safety.   "
25542|NCT02951351|"     The specific aims of this study are to compare patient experience with and without a     proparacaine drop after povidone iodine. To ensure the extra drop does not interfere with     antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal     injection before and after the application of the extra eye drop. Patients will be randomized     to undergo additional topical analgesia during intravitreal injection vs. the standard amount     of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the     additional topical analgesia does not interfere with antisepsis.   "
25543|NCT02951338|"     It is important for people with stroke to exercise in order to improve their overall recovery     and general health. However, these individuals are less physically active than people without     stroke, and they often do not achieve the recommended frequency, intensity or duration of     exercise. Low levels of physical activity leads to people with stroke becoming very unfit,     which can result in functional decline and increased difficulty being active. It is important     to determine how to encourage people with stroke to be more active in the long-term. The     transition time between the end of rehabilitation and return to the community might be an     ideal time to address barriers, and to develop positive habits, knowledge and abilities for     long-term participation in exercise. We developed the PROPEL program that combines exercise     with self-management strategies during rehabilitation to promote physical activity after     rehabilitation. Preliminary pilot findings indicate that people who completed PROPEL were     more physically active after discharge than those who did not. This study aims to evaluate     the effect of PROPEL on long-term participation in exercise after discharge from stroke     rehabilitation. This study will take place at 6 different hospitals. Participants will either     complete a control intervention (group exercise only) or the PROPEL intervention (group     exercise plus self-management). Participants' adherence to exercise for 6 months after the     end of the interventions will be evaluated using activity and heart rate monitors and     physical activity questionnaires. We expect this study will show that a simple intervention     delivered during rehabilitation will increase participation in exercise after rehabilitation.     Increased participation in exercise could then lead to improved stroke recovery and overall     health, and reduced risk of having another stroke.   "
25544|NCT02951325|"     Aim and objectives:      This trial aims to evaluate the role of adjuvant radiotherapy following chemotherapy in     patients with high-risk features on histo-pathology after radical surgery for transitional     cell carcinoma of urinary bladder   "
25545|NCT02951312|"     The study assessed the safety and ability of several doses of an orally inhaled medicine [ie,     Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with     an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease     (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the     once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the     GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered     by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared     between the two nebulizer systems to determine what effect the device had on GIS delivery.   "
25546|NCT02951299|"     Acute kidney injury (AKI) has a frequency of 7.0 % in hospital inpatients and is especially     common in critically ill patients, in whom the prevalence of acute kidney injury is greater     than 40% at admission to the intensive care unit if sepsis is present. Therefore, alternative     strategies are required to confer better or more complete renoprotection for those who     suffered from AKI.      There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline     (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of     attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We     thereby design this controlled, non-randomized clinical trial, aiming at investigating the     potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.   "
25547|NCT02951286|"     This prospective clinical study will evaluate the effect of high pull headgear for molar     intrusion, compared with the control group, in adolescent patients with open bite     malocclusion.      The study sample will consist of 24 patients with anterior open bite divided equally in two     groups. The sample will be collected consecutively from patients attending the Orthodontic     Department at Damascus university.      A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be     applied for all patients. High pull headgears will be used in the first group, while, in the     second (control) group, Open Bite Appliances will be used only.      The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be     assessed by using posteroanterior and lateral cephalometric radiographs; pre- and post-     treatment changes for each group will be evaluated.   "
25548|NCT02951273|"     General anaesthesia often reduces blood pressure whereby blood flow to the brain and other     vital organs may become insufficient. Thus, medicine is often administered during anaesthesia     to maintain blood pressure. However, it is unclear at what level blood pressure should be     aimed at during anaesthesia.      Several factors may affect blood flow to the brain during anaesthesia. During surgery on the     internal organs, a hormone may be released that dilates blood vessels and causes a so-called     mesenteric traction syndrome characterised by a decrease in blood pressure and flushing. This     reaction lasts for approximately thirty minutes and is observed in about half of the patients     who undergo surgery on the stomach and intestines. It is unknown whether a mesenteric     traction syndrome affects blood flow to the brain. Ventilation is also of importance for     blood flow to the brain. Thus, blood flow to the brain is reduced by hyperventilation and     increases if breathing is slower. It is unclear whether the relation between blood flow to     the brain and ventilation is affected during anaesthesia.      This study will evaluate how blood flow to the brain is affected by anaesthesia and standard     treatment of a possible reduction in blood pressure. Further, the study will assess whether     blood flow to the brain is affected by development of a mesenteric traction syndrome. Lastly,     the project will evaluate blood flow to the brain during short-term changes in the patient's     ventilation by adjustments on the ventilator.      Thirty patients planned for major abdominal surgery will be included in the project. The     study will take place from the patient's arrival at the operation room and until two hours     after the start of surgery. Placement of catheters and anaesthesia are according to standard     care. Blood flow to the brain will be evaluated using ultrasound. Oxygenation of the brain,     skin and muscle will be evaluated by probes that emit light. Depth of anaesthesia is assessed     by recording the electrical activity of the brain. Blood pressure is measured by a catheter     placed in an artery at the wrist and blood samples will be drawn from the catheter.   "
25549|NCT02951260|"     The purpose of this study is to evaluate the potential interaction between metformin and     exercise in order to optimize clinical guidelines for treatment of T2D.   "
25550|NCT02951247|"     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted     on hard of hearing participants to grant quality control prior to product launch. The aim of     the investigation series is to ensure zero-defect overall performance of the new hearing     systems as well as maximum benefit for the participant with the devices in comparison to     previously outstanding Phonak Hearing Systems.   "
25551|NCT02951234|"     Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children     under the age of 5 years old. This trial has been designed as a multi-center, prospective,     randomized controlled, evaluator-blinded trial with two parallel groups to determine whether     IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with     high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.   "
25605|NCT02950532|"     The objective of this investigation is to confirm the results obtained in a pilot study     showing that certain radiological parameters based on computed tomography (CT) scans seem to     reliably detect posterior ligament complex (PLC) injury without the need for Magnetic     Resonance Imaging (MRI)   "
25553|NCT02951208|"     Negative symptoms, which include the loss of motivation, social withdrawal and reduced     emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These     negative symptoms lead to significant functional impairment and enduring disability in these     youth. At present, there are no established treatments for negative symptoms. Recent evidence     from independent studies, however, suggests two promising novel treatment approaches for     negative symptoms, transcranial direct current stimulation (tDCS), and computerized     remediation strategies. The primary aim of this study is to evaluate if tDCS combined with a     virtual reality-based computerized remediation (VR) is effective for treating negative     symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms     cause.   "
25554|NCT02951195|"     This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group,     multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple     Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with     cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function     (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are     homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene     (F508del/F508del).   "
25556|NCT02951169|"     This study evaluates life quality of patients who were diagnosed with gallbladder benign     disease through Gastrointestinal Quality of Life Index (GIQLI) scale. Researchers will     establish a database including 20,000 patients. Through observational followup and statistic     analysis，identifing a model or scale to standardized surgical indication, help surgeons and     patients determine the best treatment decision.   "
25558|NCT02951143|"     Tobacco regulatory policies can have unanticipated consequences; therefore, methods that     would permit prospective estimates of the effects of potential tobacco regulations are     necessary for the development of tobacco regulatory science. The goal of this project is to     experimentally assess how smokers purchase and consume reduced-nicotine cigarettes. In     experiment 1, we will investigate how purchasing/consuming reduced-nicotine cigarettes is     related to nicotine content and absorption. In experiment 2, we will investigate how     purchasing/consuming changes when other nicotine products are available in an experimental     marketplace setting. The proposed projects can directly inform tobacco regulation by     providing estimates of the real-world effects of novel policies.   "
25559|NCT02951130|"     Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and     persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory     failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to     conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased     pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction.     In patients with CDH, left ventricular dysfunction, either caused by right ventricular     overload or a relative underdevelopment of the left ventricle, is associated with poor     prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic     contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and     has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during     the management of CDH although no randomized trials have been performed to test its efficacy.     Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and     22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone.     In the recently published VICI trial, 84% of patients with CDH received a vasoactive     medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of     CDH will be randomized to receive milrinone or placebo to establish safety of this medication     in CDH and test its efficacy in improving oxygenation.   "
25560|NCT02951117|"     This is an open-label, multicenter clinical trial designed to evaluate the safety and     potential efficacy of venetoclax and ABBV-838 combination therapy with dexamethasone in     participants with relapsed or refractory multiple myeloma (MM) who have received 2 or more     prior lines of therapy for multiple myeloma (MM). The study will consist of 2 arms: Arm A and     Arm B (if applicable). Each arm will have a dose escalation and dose expansion portion.   "
25561|NCT02951104|"     Comparison of noninvasive cardiac output monitoring device with Fick and thermodilution     methods during right heart catheterization in patients with pulmonary hypertension.   "
25562|NCT02951091|"     In-depth understanding of molecular characteristics of gastric cancer enabled us to realize     personalized medicine with targeted agents in gastric cancer treatment.The investigators     initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted     therapy based on tumor molecular profiling with standard paclitaxel therapy as second line     treatment.   "
25563|NCT02951078|"     This study is to verify the short-term efficacy and long-term prognosis of thulium laser     resection compared with conventional transurethral resection of non-muscular invasive bladder     cancer. Half of participants will receive thulium laser resection of bladder cancer, while     the other half will receive electrical transurethral resection of bladder cancer.   "
25564|NCT02951065|"     This study tests if a bristle-less tooth brush has any measurable effect on gum recession in     patients who are seen regularly for preventive dental care compared to a regular soft     tooth-brush.      Subjects are recruited from patients attending the Western University of Health Sciences     Dental Center and asked to continue regular preventive dental care while using either the     test or control brush for a year and using floss and toothpaste supplied by the researchers.     The exams include measurement of plaque, pockets and gum recession every 3 months, and     involve photographs and impressions of the teeth and gums to record any changes that occur.   "
25577|NCT02950896|"     Fetal heart rate [FHR] monitoring is used widely to assess the well-being of the baby in the     delivery period. If it is determined that an urgent cesarean delivery is required because of     fetal distress, FHR is discontinued once the mother is in the operating room in order to     allow for surgical site preparation. From this point, there is no real-time monitoring that     permits assessment of the well-being of the infant. The investigators are evaluating the     feasibility of intraoperative FHR monitoring using fetal ECG placed on the mother's upper     abdominal wall and the standard acoustic device routinely used. The investigators will     compare these to the traditional well-being tests: umbilical arterial blood gas and Apgar     score.      The first 15 subjects will be recruited from pregnant women who have scheduled induction of     labor. The subsequent 40 subjects will be recruited from pregnant women who have scheduled     cesarean sections.   "
25565|NCT02951052|"     The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to     establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants with     current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors     (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM)     long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3,     multi-phase, randomized, open label, active-controlled, multicenter, parallel-group,     non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult participants who are     stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to     demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg +     RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV     regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible participants will be     randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch     to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4     weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52,     participants who were randomized to continue their current ART regimen will be given an     option to switch to CAB LA + RPV LA injections. Those participants would transition to LA     dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM     CAB LA + RPV LA injections at Week 56.   "
25566|NCT02951039|"     In order to understand the risks and benefits of edoxaban use in a real-world clinical     setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed     this non-interventional study to gain insight into the safety (bleeding, liver adverse     events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban     use in non-preselected patients with NVAF.   "
25567|NCT02951026|"     This long-term extension study is designed to monitor the long-term safety, tolerability, and     efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of     subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored     SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be     administered in this study.   "
25583|NCT02950818|"     To evaluate the effectiveness of Take Heart, a behavioral/educational program for adults age     50+ with heart disease, or with at least two risk factors for heart disease, that helps them     to better manage their health condition(s). Take Heart is a new version of an evidence-based     program that has recently been adapted to be suitable for the needs of adults residing in     Detroit.   "
25568|NCT02951013|"     The hemoglobin concentrations of patients assigned to the restrictive strategy of transfusion     were maintained in the range of 6.0 to 8.0 g per deciliter, with a transfusion given when the     hemoglobin concentration fell below 6.0 g per deciliter. Patients assigned to the liberal     strategy of transfusion, the hemoglobin concentrations were maintained in the range of 8.0 to     10.0 g per deciliter, with a threshold for transfusion of 8.0 g per deciliter.      The primary outcome: Death from all causes in the Six months after randomization,     Perioperative complications: sepsis , Pulmonary complications, Portal vein thrombosis,     Hepatic artery thrombosis, Adverse event of transfusion.      Secondary outcomes included: Intraoperative blood transfusion, Postoperative blood     transfusion, Postoperative inflammatory reaction, Mechanical ventilation time in the     intensive care unit, Lengths of stay in the intensive care unit and the hospital were also     recorded.   "
25569|NCT02951000|"     Influence of the platysma suture on postoperative pain and wound healing.   "
25570|NCT02950987|"     This study is evaluating Whole Body MRI as a possible screening tool to diagnose cancer for     people with LFS and other inherited cancer predisposition syndromes.   "
25571|NCT02950974|"     Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose     of sterofundin solution given to healthy volunteer in the resuscitation manner compared with     normal saline solution.   "
25572|NCT02950961|"     Implementation of Tailored Collaborative Care for Women Veterans (CCWV) is designed to     enhance primary care-mental health integration for women Veterans, by tailoring services to     women Veterans' and providers' needs and providing an evidence-based intervention,     Coordinated Anxiety Learning and Management, to address anxiety and depression in a     patient-centered approach. CCWV will be implemented in four of the Women's Health     Practice-Based Research Network sites, with careful attention to local tailoring and     adaptation to enhance the fit of the care model in varied local contexts.   "
25573|NCT02950948|"     The main objective of this study will be to assess the efficacy of natural progesterone at a     daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the     ongoing pregnancy rate.      The secondary objectives will be the rate of endometrial biopsy showing an in phase     endometrium after 3 months of treatment.      The length of the luteal phase of the menstrual cycle after treatment will also be assessed     and compared with the initial duration (from LH peak to onset of menstruation).   "
25574|NCT02950935|"     The main objective of this study will be to assess the efficacy of natural progesterone at a     daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of     threatened abortion. The secondary objectives will be the efficacy of progesterone in     reducing both pain and uterine contractions.   "
25575|NCT02950922|"     This is a multi-center, randomized, vehicle-controlled, double-blind Phase 2 study in adults     and adolescent subjects with mild to moderate atopic dermatitis.   "
25576|NCT02950909|"     The primary aim of this study therefore is to investigate the effects on pain and disability     of an emphasized exercise program targeting the deep neck extensor semispinalis cervicis and     a general exercise program for all neck extensor muscles in patients with chronic neck pain.     As a secondary aim , the effect of both exercise programs on activation pattern of two neck     extensor muscles was investigated with electromyography (EMG). The investigators hypothesized     that both exercise programs would have similar effects on pain alleviation and pain related     disability, but that the emphasized exercise program for the deep semispinalis cervicis would     improve its activation more compared to the general exercise program. The results of this     study will be relevant for designing effective rehabilitation/training programs for patients     with chronic neck pain.   "
25578|NCT02950883|"     The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice     daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in     comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6)     with cystic fibrosis.   "
25581|NCT02950844|"     Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence     is increasing partly due to the ageing population and it has been referred to as a growing     epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of     palpitations and increasing the risk of stroke, heart failure and death. Percutaneous     catheter ablation is a safe treatment option in symptomatic patients with AF. The success     rate of these procedures have improved with time due to our better understanding of AF,     development of new techniques and technology, and greater physician experience. However, the     success rate of these procedures still only remains around 70%. This is contributed to our     limited ability to find the areas that drive the AF.      STAR mapping is a novel mapping system that has been developed with a view of better     identifying the sites that drive AF, through taking into account the mechanisms of AF that     have already been demonstrated. Data from this study will be used to refine the     identification of drivers in the fibrillation left atrium with enormous potential to simplify     ablation and improve success rates and thereby reducing the need for further procedures.      To better validate this mapping system the investigators also aim to use it in participants     with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can     be readily identified with the existing mapping systems used in clinical practice. The     investigators will demonstrate that the STAR mapping algorithm can effectively map AT.      To gain further understanding of the changes that occur in the left upper chamber of the     heart in the context of AF half of the participants with AF will undergo cardiac magnetic     resonance imaging to assess for the presence of scar. This will enhance our understanding of     how atrial remodelling promotes AF, which may point to ways of modifying this process and     preventing AF.   "
25585|NCT02950792|"     Current dose escalation regimens with and without chemotherapy have failed to achieve     improved local control and overall survival over standard of care therapy to date.     Difficulties with dose escalation have been largely due to dose limiting toxicities of     surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real     time, online adaptive planning using magnetic resonance imaging (MRI) could achieve     significant volume reduction of primary lung disease over the course of therapy, thereby     reducing dose to normal structures, and providing a mechanism in which to dose escalate     safely, and more effectively with accurate target delineation.      The investigators hypothesize that MRI based adaptive planning will provide a novel method to     dose escalate safely with acceptable organ at risk doses. In addition, further improvements     in radiotherapy targeting accuracy, normal tissue avoidance, and conformality of     target-tissue coverage will be achieved through the use of 4D real-time tracking which is     derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography     Simulator (CTsim) with advanced non-rigid image-registration tools.   "
25586|NCT02950779|"     Inflammatory bowel disease (IBD) is a chronic disease, which causes inflammation of the gut.     People with this disease are often poorly nourished. Problems caused by poor nutrition such     as poor wound healing can be reduced if it is recognised and treated early.      When people with IBD attend outpatients clinic with their IBD specialist they are weighed and     their BMI calculated to indicate if they are poorly nourished. Weight and BMI may not always     provide a good assessment of how well nourished a person is because it does not describe the     amount of muscle in the body in proportion to fat. A person with a low or decreasing amount     of muscle but a normal or high BMI is at risk of nutritional problems. Measuring the amount     of muscle someone with IBD has in routine practice poses a challenge to clinicians due to     time constraints. One-way of measuring the amount of muscle a person has is to measure their     muscle strength. This can be measured by recording the strength of a person's handgrip.     Handgrip strength can be measured using a hand-held device called a dynamometer.      This study aims to test whether it is possible to measure the handgrip strength of people     with IBD attending outpatient's clinic. It also aims to test how the measure obtained     compares with other methods of assessing whether someone is malnourished and their health.     People with a diagnosis of IBD who are aged 18 or older and who are scheduled to attend IBD     outpatients clinic in one hospital will be asked to take part in the study. Their handgrip     strength will be measured each time they attend clinic over a nine-month period in addition     to other information about their health and nutritional state. This study forms part of a     Masters in Research being undertaken with The University of Southampton.   "
25587|NCT02950766|"     This research study is evaluating a new type of Kidney Cancer vaccine called Personalized     NeoAntigen Cancer Vaccineas a possible treatment for Kidney Cancer.      The following intervention will be involved in this study:        -  Personalized Neoantigen Vaccine        -  Poly-ICLC (Hiltonol)        -  Ipilimumab   "
25588|NCT02950753|"     Lactated Ringer's (LR) solution bolus is commonly administered in the emergency department     setting to seriously ill patients. It is also common to obtain blood samples to determine     serum lactate levels to aid in the assessment of the patient's degree of illness. This study     endeavors to determine if serum lactate levels are affected by LR fluid administration in     healthy adult individuals as compared to those who receive Normal Saline (NS). Healthy adult     volunteers will be used as subjects so that the illness of hospital patients does not     confound the results.   "
25589|NCT02950740|"     Food intake pattern and lifestyle are associated with the nutritional status and intestinal     microbiota composition, and such factors are important for the proper growth and development     during early childhood, as well as for the health throughout life. This cross-sectional and     multicenter study will include a total of 200 children aged between 1-3 years, enrolled in     early childhood public schools from different regions of Brazil (Santo André, Uberaba, Porto     Alegre and Natal). Data on birth and gestational history will be collected in a form.     Nutritional status will be assessed by determining the weight and height, with subsequent     calculations and classification of nutritional indices. A single blood sample will be     collected to investigate the blood levels of vitamins A and D, iron, calcium, alkaline     phosphatase and zinc, and feces will be collected for intestinal microbiota analysis. Food     intake will be assessed by direct weighing of food in 2 non-consecutive days. Considering the     importance of a well-balanced diet and its effects on the child's growth, development and     intestinal colonization, this study purpose is to investigate potential associations among     food intake, nutritional status and intestinal microbiota of early childhood infants from     four regions of Brazil.   "
25590|NCT02950727|"     In this current study a comparison between 3 positional screws versus the adjustable plating     system in conjunction with 2 positional screws. The patients will be selected to have     retrognathic mandible requiring advancement. Hypothetically the advantage of the adjustable     plating system will be compared with the three positional screws. In theory, the     investigators will be using the inherent advantage of the intraoperative flexibility of the     adjustable plating system in verifying the position of the proximal segment (condylar     segment), hence eliminating the immediate postoperative relapse that is reported with using     three positional screws. This will be evaluated both clinically and cephalometrically.   "
25606|NCT02950519|"     There is no accepted standard for the frequency of monitoring endotracheal tube cuff     pressures (ETCP). We plan on comparing two strategies for monitoring ETCP in mechanically     ventilated patients. The two strategies will be the currently employed practice protocol as     outlined in the Respiratory Therapy Protocol at Barnes-Jewish Hospital (BJH) which requires     ETCP to be assessed immediately after the endotracheal tube is placed and after any     manipulation of the endotracheal tube to include repositioning, manipulation of the cuff     volume, or presence of an audible leak. We will compare this current practice to a more     intensive monitoring of ETCP which is employed at some hospitals and includes the same     elements as noted in the current practice plus monitoring ETCP every work shift (every 8     hours or three times per day).   "
25658|NCT02949843|"     This phase II trial studies how well targeted therapy works in treating patients with     incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other     genetic mutations or other specific proteins may work better when a patient has cancer caused     by a driver mutation and the treatment that targets that mutation stops working.   "
25591|NCT02950714|"     This study asks whether persons with lupus will use and uptake the information and services     of the web-based lupus interactive navigator (LIN) on a regular basis and whether this uptake     will be associated with better self-management, improved coping, higher sense of control over     their life, and overall improved health.      Systemic lupus erythematosus is an incurable chronic multi-organ inflammatory disease that     affects preferentially young women. Unmet needs include a 15% excess in mortality, high     morbidity and poor work outcomes. Despite prevalence of 1:2000, lupus is mostly unknown from     the public and access to specialized care remains limited. Therefore, persons with lupus and     their caregivers have difficulty finding high quality information relevant to their lupus     journey.      The LIN research team consists of a lupus clinical expert and researcher, a clinical     psychologist and behavioral researcher, and a health information specialist. This team,     funded by the Canadian Institutes of Health Research (CIHR), was responsible for the     development of the LIN, a web-based navigator designed to promote self-care. The LIN is     completed and the team will work with several stakeholders for dissemination: Lupus Canada,     the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS), the     Arthritis Alliance of Canada, and lupus patient advisers. CaNIOS centres will be to     randomized to immediate access to the LIN (LIN_NOW group) or usual care with crossover at 3     months (LIN_WAIT group). At baseline, all patients meeting entry criteria will be contacted,     and asked to complete online questionnaires. At three months, a second online assessment will     be performed before crossing over those from the centres randomized to usual care in order to     now provide them with an access to the LIN. A final assessment will be performed at six     months. Comparisons of baseline versus LIN exposure over three months will be performed in     all patients at the end of the study; comparison of LIN use versus usual care will be done at     three months; and retention of use at six months after LIN exposure will be documented in the     first group randomized to LIN. The main outcome will be the Patient Activation Measure, a     valid tool that measures the level of patient engagement. Secondary outcomes will include     variables describing access and use of the LIN captured by the LIN server, coping,     self-efficacy, and global health status.   "
25592|NCT02950701|"     The purpose of this study is to collect non-invasive opportunity sample data in suspected or     known cases of carbon monoxide poisoning.   "
25593|NCT02950688|"     The purpose of this study is to evaluate the immune response produced by a seasonal live     attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will be     followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical     response, and viral shedding after exposure to the wild-type A/California/2009-like influenza     challenge virus.   "
25594|NCT02950675|"     The relationship of body function, participation and quality of life in patients with burn: A     longitudinal study   "
25595|NCT02950662|"     The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in     terms of retention and patient satisfaction   "
25596|NCT02950649|"     This project is designed to assess the impact of pre-operative use of non-invasive     hemodynamic monitoring technologies on improving peri-operative and post-operative care of     moderate to high-risk surgical patients with poor functional status by improving the     detection of reduced cardiovascular function.   "
25597|NCT02950636|"     The purpose of this study is to learn if a structured yoga program can reduce anxiety,     improve depression, and improve quality of life in patients with medication resistant     epilepsy (MRE).   "
25598|NCT02950623|"     Cross over design the investigator divide participants to two groups group (A) will receive     rapid heat cured denture base material and group (b) will receive the acrylic denture     modified by titanium dioxide nanoparticles and after washout period alternatively group (a)     will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b)     will receive rapid heat cured denture base material the investigator will take swaps from     dentures to count the anaerobic bacteria.   "
25599|NCT02950610|"     The purpose of this is to analyse human exhaled breath by means of a device called electronic     nose(eNose) in patients with non-alcoholic fatty liver disease (NAFLD) as a way to     non-invasive assessment of liver disease.This device is medically adapted and clinically     validated in patients with lung conditions.   "
25600|NCT02950597|"     Study Details What is the study design? (eg, randomized, double-blind) Observational     Prospective Study What are the overall objectives of the study? This project is designed to     assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure     outpatient clinics. There will be no alteration to patient management for this study. Rather     this study seeks to assess the utility of the device in this patient care setting by     surveying the clinicians involved.      What is the primary endpoint? For this phase I study, the primary endpoint will be the heart     clinician's survey results.      What is/are the secondary endpoint(s)? Secondary markers will include: patient survey     results, heart failure classification, renal function, blood pressure, cardiac function     tests, and pulmonary function tests.      How your research will contribute to the advancement of scientific knowledge? ☒This study     will confirm/strengthen existing knowledge.        -  This study will test a completely novel hypothesis.        -  This study will explore novel endpoints. ☐Other [please describe]:   "
25601|NCT02950584|"     Measurement of surface roughness of tow different material of denture base to find out which     material is more hygienic by decreasing the amount of bacterial accumulation.   "
25602|NCT02950571|"     This study will be a randomized controlled trial that investigates the effectiveness of     digital picture frames (DPF) installed in inpatient rooms on long stay inpatient wards     servicing schizophrenia clients at CAMH. The effects on client experience will consider the     domains of self-concept, interactions with healthcare staff, perception of space, and     implications for the recovery process. The comparison of inpatient client experience with     DPFs versus a control group (Treatment as Usual - TAU), offers the opportunity to examine the     effectiveness of this type of environmental adaptation. This trial builds upon earlier work     that demonstrated the feasibility of DPFs in this context.   "
25607|NCT02950506|"     The purpose of this study is to investigate whether tDCS enhances the effect of cognitive     remediation therapy on cognition and functional outcome in patients with epilepsy. There has     been evidence that working memory performance is enhanced in healthy subjects. Acute tDCS     studies have found improvements in working memory performance in subjects with other     neurological diseases. To date, there have been no published studies examining whether can     enhance learning during multi-session cognitive remediation over 2 weeks in subjects with     epilepsy. This study could have potential application as a non-invasive clinical intervention     for interictal dysfunction in epilepsy.   "
25608|NCT02950493|"     Use of Reactivated DEFINITY® in Patients Undergoing Stress Echo Purpose of the study: Each     patient undergoing a stress echocardiogram uses a full vial of DEFINITY® contrast agent.     During infusion, this often condenses back to its liquid phase due to manual pressure applied     in the syringe. At this point, it is not optimal to be used at current ultrasound settings     for stress echocardiography. This research project will test whether this condensed DEFINITY®     can be reactivated by ultrasound using the same transducer used to image the patient.      Eligibility: Same criteria as required for stress echo procedure. Interventions and     Evaluations: Inject condensed DEFINITY® at end of stress test Follow Up: The patient would be     observed by echo lab staff for half an hour following completion of the stress test. There     would be no longitudinal follow up.   "
25609|NCT02950480|"     A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be     undergoing mastectomy with immediate tissue-expander reconstruction to determine whether     treatment with zafirlukast (20mg PO BID) can reduce or prevent the development of capsular     contracture.   "
25610|NCT02950467|"     The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is     a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).   "
25611|NCT02950454|"     This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high     intensity interval training in people with progressive multiple sclerosis. A control group of     people with progressive multiple sclerosis will undergo continuous moderate intensity     exercise, twice weekly for 8 weeks.   "
25612|NCT02950441|"     This study is designed to assess the physiological consequences of elevating Nicotinamide     Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in     skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.   "
25613|NCT02950428|"     The purpose of this investigation is to collect data pertaining to the safety and performance     of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA     Transapical Delivery System. This device is intended for treatment of subjects with severe     aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR)     surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive     transapical implantation in a well-defined population.   "
25614|NCT02950415|"     Children undergoing anesthesia are often very frightened by the experience. This can lead to     bed wetting, nightmares and stranger anxiety that can last for weeks. Moreover, this can     influence their future experiences with anesthesia and surgery. The investigators believe the     presence of a parent via video might work better as parental fear is not transferred to the     child. The investigators also believe that parents who are coached on how to assist their     child during anesthesia will have a better impact. As such the investigators are carrying out     this study to assess whether parents who are coached and are present in either video or     physical form will be more effective in reducing anxiety at induction of anesthesia.   "
25615|NCT02950402|"     This study evaluates whether the consumption of California dried plums can be beneficial to     your health. Previous studies using dried plums have shown beneficial effects on bone and     cardiovascular health. In addition the investigators hope to learn how dried plums might     change your bowel habits, and if the carbohydrates in the plums are fermented in your     digestive tract.   "
25616|NCT02950389|"     Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact     with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing     impairment of neutrophil function can contribute to the chronic inflammation state of uremic     patients, and the increased risk of bacterial infections or vascular calcifications. The aim     of this crossover observational study was to assess the difference in free light chain     removal by three different hemodialysis filters in patients not affected by multiple myeloma.      Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer     BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7 High     Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The patients     were randomized into two groups of treatment lasting six weeks each. The dialysis sessions     checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa     (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive protein (CRP) and     albumin were checked.   "
25617|NCT02950376|"     The purpose of this research is to develop an objective assessment based on the virtual     reality techniques which is used for evaluate addiction severity.   "
25618|NCT02950363|"     The purpose of this study is to determine whether use of a suite of smart phone enabled     mobile health devices can reduce burnout in medical trainees. Such applications can then be     used in more general populations with the same goal in mind.   "
25631|NCT02950194|"     The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI     (one-step procedure a panniculectomy by a plastic surgeon was performed together with a mesh     augmentation of the abdominal wall by a general surgeon) at least 1 year post-operatively.     Evaluation of the PPAWI approach by clinical examination with Quality of Life questionnaire     and by ultrasound examination.   "
25632|NCT02950181|"     This study involves looking at Cerebral oximetry measurements in pediatric and neonatal     patients who are experiencing a critical illness. Such as Altered mental status, seizures,     trauma, sepsis, etc.   "
25660|NCT02949817|"     This study was designed to establish the clinical evidence for effect of video-game based     rehabilitation therapy system using IMU sensors as a game interface, newly-developed in     Korea, on upper limb function of children with cerebral palsy. First, the investigators would     compare the effect of video-game based rehabilitation therapy to conventional occupational     therapy.   "
25619|NCT02950350|"     Cervical cancer is the most common reproductive malignancy in developing country. Due to     local invasion, radical hysterectomy cannot be performed in advanced cervical cancer (FIGO     IIB - IVA) , so that radiation combined with chemoradiation (RCTX) is a traditional treatment     nowadays. Lack of precise treatment strategies, recurrent ratesand metastasisis high ,and the     5-year survival rate is less than 50%. Therefore, it needs to explore a new strategy for     improving the prognosis of advanced cervical cancer.      The prognosis of cervical cancer is closely related to its stages ,while the current FIGO     clinical stage is too subjective , for example different gynecologic oncologists may give     different diagnosis to the same patient. MRI, CT, PET/CT imaging examinations are commonly     used as a referrence for clinical staging, but the sensitivity and specificity are not     satisfied. In addition, lymph node metastasis significantly impacts the prognosis of cervical     cancer . However, the lymph node invasion is not in current staging criteria.      Precision treatment after surgical staging is recommended by NCCN recently .Surgical staging     in patients with advancedcervical cancer is safe and does not delay primary RCTX in few     randomized study.Whether overall survival benefit the long-term clinical follow-up surgical     staging is unknown.Blocking bilateral uterine artery can effectively reduce the tumor size     and increase the operability , which has been conformed in locally advanced cervical cancer.     Furthermore, ovarian dysfunction caused by RCTX could be avoided by ovarian transposition via     surgical staging .      Based on this, we suggesta new surgical stagingfor patients with advanced cervical cancer ,     which includinglaparoscopic pelvic and para-aortic lymphadenectomy , uterine blood vessel     blocking and ovarian transportation, in order to perform individualized postoperative RCTX,     reduce tumor load , preserve ovarian function and improve life quality.   "
25620|NCT02950337|"     Lung cancer is the leading cause of cancer death in both men and women in the United States.     In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and     bronchus, resulting in 159,260 deaths. Per the current National Comprehensive Cancer Network     (NCCN) guidelines, the standard of care for early-stage non-small cell lung cancer (NSCLC) is     lobectomy with lymph node dissection. Historically, medically inoperable early-stage NSCLC     patients have been offered definitive external beam radiotherapy (EBRT) as primary management     but, overall, studies have consistently shown poor patient outcomes. Stereotactic body     radiation therapy (SBRT) is a technique which delivers very high doses of radiation per     fraction over one to five fractions to precisely defined volumes with steep dose gradients.     SBRT is commonly utilized for the treatment of biopsy-proven early stage NSCLC in the     medically inoperable patient.   "
25621|NCT02950324|"     The purpose of this study is to evaluate the effect of a multimodal pre-operative     prehabilitation programme during neo-adjuvant therapy on cardiopulmonary exercise performance     and insulin resistance prior to resection for oesophago-gastric cancer.   "
25622|NCT02950311|"     This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3     years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider     at a Duke- affiliated otolaryngology clinic.   "
25623|NCT02950298|"     The primary purpose of this study is to:        -  Document the developmental outcomes of individuals with Pompe disease treated with          long-term enzyme-replacement therapy (ERT) through school-age (ages 6-18) using measures          of cognitive functioning, academic skills, and speech and language abilities.        -  Investigate possible cognitive processing speed weaknesses using BrainBaseline          neurocognitive assessment software.        -  Investigate the relationship between behavior and other developmental factors including          speech and language ability and cognitive ability.        -  Explore if the use of selected iPad applications may help strengthen cognitive          processing speed in children with Pompe disease   "
25624|NCT02950285|"     The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by     preventing stroke. The investigators propose to implement an automated algorithm using     electronic medical record (EMR) data to alert physicians in a large primary care practice     network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated     stroke risk that are not taking an anticoagulant for stroke prevention. The investigators     hypothesize that interventions to notify physicians of such individuals may prompt     reassessment for the need for anticoagulation, and thereby increase guideline-indicated     anticoagulation rates. Additionally, in a survey component, physicians will characterize     reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.   "
25625|NCT02950272|"     The CARD study is a observational study which includes Chinese adolescents with diabetes aged     18-30. The study aims to explore the status of disease treatment, self-management, the     relationship between disease treatment and disease outcome in Chinese adolescents with     diabetes.   "
25626|NCT02950259|"     The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients     with early stage breast cancer (ESBC).   "
25627|NCT02950246|"     Implementation of perineural catheters may lead to infection by catheter colonization.     Catheters may be colonized by the bacteria present on the skin. This is most often commensal     organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral     nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often     silent because in the same study only 3% of patients had signs of local inflammation and one     psoas abscess was observed (0.07%). The germs are most often coagulase negative staphylococci     (61%) and gram negative bacillus (21.6%).   "
25628|NCT02950233|"     The objective of the PAIN-STOP trial is to assess the feasibility of a larger randomized     controlled trial (RCT) evaluating NMDA antagonists and IV steroids, as compared to placebo,     in decreasing the chances of clinically significant persistent post-surgical pain (PPSP)     after video assisted thoracoscopic surgeries (VATS). This is a multi-centre randomized,     controlled clinical trial with a 2 x 2 factorial design. The pilot phase of the trial will     recruit 48 patients and follow them for 3 months. Patients will be randomized to one of four     groups: 1) NMDA active + Steroid placebo; 2) Steroid active + NMDA placebo; 3) NMDA active +     Steroid active; 4) NMDA placebo + Steroid placebo.   "
25629|NCT02950220|"     This phase I/Ib trial studies the side effects and best dose of ibrutinib when given together     with pembrolizumab and to see how well they work in treating patients with non-Hodgkin     lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as     pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Given pembrolizumab and ibrutinib may work better in treating patients with non-Hodgkin     lymphoma.   "
25630|NCT02950207|"     Mono-centric, observational, prospective study, designed for pts with diagnosis of     hormone-positive breast cancer to evaluate the correlation between the response to hormonal     treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of     patients   "
25633|NCT02950168|"     Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic     procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for     short periods of NOAC interruption without heparin bridging. There is only minimal     information on the peri-procedural usage pattern of edoxaban and the related outcome data     currently available. Therefore, further real-world clinical data on the peri-procedural usage     pattern of edoxaban within any diagnostic or interventional procedure in patients with     non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in     this registry.   "
25634|NCT02950155|"     A randomized, double-blind, placebo-controlled multicenter study evaluating the safety and     efficacy of Rituximab (Mabthera®) in patients with new onset generalized myasthenia gravis     (MG).   "
25635|NCT02950142|"     Cluster randomised controlled trial to evaluate what the effect is of evidence-based order     sets aimed at five indications on the appropriateness of laboratory test ordering in primary     care.   "
25636|NCT02950129|"     The subjects will undergo a specific physical exam of tests reported to be diagnostic of     sacroiliac joint (SIJ) pain prior to receiving the routine injection in the SIJ that which is     being performed as part of their normal medical care. Routine care involves use of any number     of these tests, but doesn't routinely include assessment of all 6 tests in all patient's     treatment. The subject will fill out a Visual Analog Scale for pain and a pain drawing prior     to and after the injection.      The tests will be repeated after the injection.      The investigators propose to investigate a cluster of tests proposed by Laslett as well as     compare the results of the ASLR and the Gillet Test both before and after SIJ injection to     determine the validity of these tests in a low back patients presenting for injections     thought to be from the sacroiliac joint. The secondary purpose would be the development of a     clinical predictor rule to determine examination characteristics of patients who may benefit     from intraarticular injections of the SIJ.   "
25637|NCT02950116|"     Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and     thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma,     bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while     asthma is mostly characterized by obstruction due to bronchoconstriction of the airways,     obstruction in bronchiectasis and CF originates primarily from mucus retention due to     abnormal airway clearance mechanisms.      The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of     early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is     required for this test makes it very convenient for use in any age category.      Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric     CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung     disease in asthma children is less clearly demonstrated. No data were found on LCI calculated     from the N2-MBW-test in children with bronchiectasis.   "
25638|NCT02950103|"     Synthetic phosphoethanolamine is a primary amine which has a critical role in the     biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer activity.   "
25639|NCT02950090|"     MobilWise, a worksite physical activity intervention for employees at high risk for knee     osteoarthritis (OA), is being tested in a developmental randomized controlled trial at a     collaborating worksite to determine if remotely- coached physical activity counseling can     increase and sustain physical activity in this population. Knee osteoarthritis is a major     public health problem and a leading cause of disability and work absenteeism/presenteeism in     the US workforce. The overarching goal of this program is to develop and disseminate an     affordable, efficient, efficacious physical activity intervention to large groups of     employees at risk for knee OA. The Mobil Wise intervention is administered by health     professionals, who will use data transmitted from an affordable accelerometer-based personal     monitor (Fitbit Flex) via customized remote coach interface to 1) allow the remote coach to     view and collect physical activity data generated by the personal monitor, and 2) use that     data to formulate and provide tailored behavioral support, using motivational interviewing.     This project has the potential to have a tremendous impact on improving symptoms and quality     of life of persons with chronic knee pain and decreasing the functional limitation, work     absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.   "
25640|NCT02950077|"     The study is a 'pilot study' to assess the effect of a mindfulness-based stress reduction     (MBSR) intervention on patients with autoimmune liver disease specifically autoimmune     hepatitis type I. MBSR is a standardized intervention that has shown benefit in addiction     disorders and other psychiatric disorders. There has been no study evaluating or showing the     benefit of the use of MBSR in autoimmune liver disease. With published data showing the     evidence of an association of stress and relapse in autoimmune hepatitis, it is hypothesized     that such an intervention such as MBSR may have therapeutic effect in patients with     autoimmune liver disease.   "
25641|NCT02950064|"     This is a phase 1, Open-label, multicenter Dose Escalation study of BTP-114, a novel platinum     product, in patients with advanced solid tumors and BRCA or other DNA repair mutation. This     clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2     (Expansion). The purpose of this study is to evaluate the safety, pharmacokinetics and the     anti-cancer activity of BTP-114.   "
25642|NCT02950051|"     The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline     treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by     combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab,     Obinutuzumab), which may induce extremely long lasting remissions.   "
25643|NCT02950038|"     The goal of this clinical research study is to learn if Imbruvica (ibrutinib) alone and then     in combination with Opdivo (nivolumab) can control NSCLC in patients who have received     previous chemotherapy treatment.   "
25657|NCT02949856|"     This study evaluates difference of the endotracheal tube cuff pressure between a tapered-     versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.      Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and     cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the     supine neutral position and is measured after the change to the neck extension.   "
25644|NCT02950025|"     In light of this new technology and preliminary findings of low toxicity of online, adaptive,     magnetic resonance (M)-guided stereotactic radiation on a single arm prospective study, the     investigators propose to compare this technique to online MR-guided stereotactic body     radiation therapy (SBRT) without adaptation. Online plan adaptation increases treatment times     for patients and comprises an increased burden on technical and clinical staff. Although     preliminary trial results are encouraging, it remains unclear if the dosimetric benefits of     online-adaptive planning studies will translate to measurable improvements in clinical     outcomes that merit its routine use. In our preliminary study, plan adaptation was most often     required when tumors were adjacent to the gastrointestinal tract (the esophagus to the     sigmoid colon), as those structures were most commonly the dose-limiting structures and were     noted to change in location on a day-to-day basis. For these reasons, abdominal disease sites     have historically highlighted the limitations of SBRT. Specifically, the investigators will     enroll patients with oligometastatic or unresectable primary disease of the non-liver abdomen     to a randomized, prospective trial.      Patients will be randomized to one of two treatment arms, in which they will receive either     online-adaptive, MRI-guided SBRT or non-adaptive MRI-guided SBRT. Both patient groups will     undergo MRI simulation and MRI treatment localization with online MR monitoring and/or     gating. All patients will be treated in five fractions over one to two weeks. By adhering to     strict normal tissue constraints, the investigators expect toxicity to be within the current     standard of care for the non-adaptive arm, with reduction in toxicity in the arm of patients     who undergo adaptation based on daily anatomic changes.   "
25645|NCT02950012|"     The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis     MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in     otherwise healthy adults.   "
25646|NCT02949999|"     The study is a single-centre, double-blind, placebo controlled, randomized, ascending     multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic     profiles of voclosporin.   "
25647|NCT02949986|"     There are many exercise approaches that have demonstrated effectiveness in reducing falls and     fall risk in community-dwelling older adults. The Otago Exercise Program is one such program.     The Otago Exercise Program has been tested in four randomized controlled trials and one     controlled multi-center trial and was found to reduce falls in older men and women. The focus     of the Otago Exercise Program is on improving strength and balance with a home-based balance     exercise program. The goal of the current study is to evaluate whether a self-administered,     tablet-based version of the Otago fall prevention program is both feasible and effective for     reducing fall risk and improving balance in community-dwelling older adults.   "
25648|NCT02949973|"     An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict     clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg BID in     combination with standard of care in patients with active lupus nephritis   "
25649|NCT02949960|"     The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared     to vehicle control following 28 days of twice-daily topical application to selected target     lesions in male and female patients with mild to moderate atopic dermatitis (AD).   "
25650|NCT02949947|"     The goal of this clinical research study is to compare Injectafer® (ferric carboxymaltose)     with an iron supplement to learn which may be more effective in improving red blood cell     counts in patients who have iron-deficiency anemia (a low red blood cell count) because of a     gastrointestinal stromal tumor (GIST) and/or systemic therapy.      The safety of ferric carboxymaltose will also be studied.   "
25651|NCT02949934|"     The purpose of this study is to determine whether the catechol-O-methyltransferase (COMT)     inhibitor tolcapone, relative to placebo, reduces alcohol drinking and alcohol cue-elicited     brain activation and increases brain activation associated with cognitive control as a     function of a participant's genotype at a polymorphism in the COMT gene.   "
25652|NCT02949921|"     The objective of this study is to provide a preliminary assessment of the radiographic     appearance of Radiesse material that has been injected into the dorsum of the hands.   "
25653|NCT02949908|"     This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm     study to measure treatment satisfaction of relapsing remitting MS (RRMS) subjects on Rebif     after discontinuing initial first-line treatment.This study is a regional study with 3     participating countries: Belgium, the Netherlands and Switzerland   "
25654|NCT02949895|"     A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung     cancer   "
25655|NCT02949882|"     There is a relative high prevalence of constipation and antibiotic-associated diarrhoea (AAD)     in the elderly residents of nursing homes, mainly due to high antibiotic and medication     usage. Constipation and diarrhoea causes a substantial burden on lives of the frail elderly     and significantly reduces the quality of life (QoL). In addition, these circumstances lead to     a higher workload for healthcare workers and treatment of constipation and diarrhoea increase     costs in healthcare. There are indications that the gastrointestinal microbiome is altered in     conditions, such as constipation and AAD. Research indicates that probiotics show potential     in the treatment of constipation, AAD and infectious diarrhoea. Probiotics can restore the     aberrant gastrointestinal microbiome and thereby possibly treat/prevent constipation and     diarrhoea in the frail elderly population. To illustrate, a previous pilot study of probiotic     administration in elderly residents of a nursing home demonstrated a reduced prevalence of     constipation and diarrhoea stool types and a higher prevalence of ideal stool types during     the intervention compared to the baseline period. These promising results demand for a     confirmatory study in this population.   "
25656|NCT02949869|"     The reported rate of unsuccessful traditional LP in children (defined as the inability to     obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors     affect LP success including provider experience. CSF is obtained by puncturing the     subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many     have hypothesized that the width of this space may predict success. Anecdotally, trainees and     those with less experience, tend to perform the LP too low (caudally), where the subarachnoid     space tapers, or too laterally (off the midline) resulting in higher failure rates. The     investigators seek to determine if planned LP insertion sites vary between training and     attendings, and if so, could the decreased success be explained by smaller subarachnoid     spaces.   "
25661|NCT02949804|"     Almost everyone is aware these days is aware about the risk of smoking. Still many people     start this habit specially in early life and during college year. We aim to investigate in     this study if there is a drive to smoke in people with vasovagal tendency to improve their     symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness,     smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation     between smoking and a positive tilt table test which is indicative of vasovagal tendency. By     collecting the information regarding smoking habit and vasovagal symptoms analysis can be     done to see if there is correlation between these two factors   "
25662|NCT02949791|"     Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a     promising therapy for peritoneal carcinomatosis (PC) of various origins. Rather than the     pharmacokinetic advantage, the uptake of chemotherapy by tumor tissue has been proposed as     the best pharmacologic endpoint to assure the efficacy of HIPEC.      The primary endpoints of the present phase II randomized study are to test whether the     increased intra abdominal pressure (IAP) during HIPEC could:        -  enhance the penetration of cisplatin into the residual neoplastic and normal tissues;        -  elicit changes on pharmacokinetic advantage of cisplatin.      Secondary endpoints are to evaluate the:        -  impact of high IAP on intraoperatory hemodynamic and respiratory parameters;        -  impact on short-term surgical outcomes (in hospital stay, morbidity, mortality).      Patients affected by PC from colorectal cancer or pseudomyxoma peritonei, submitted to     complete cytoreduction (residual disease <2.5mm) would be eligible for the study. HIPEC will     be performed using closed abdomen technique and cisplatin + mitomycin-C. Patients will be     randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be     measured using bladder catheter. High IAP will be obtained increasing the volume of     perfusate.      Thirty-eight patients (19 in each study groups) will be enrolled in 30 months. The randomized     groups will be stratified according to tumor type.   "
25663|NCT02949778|"     Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive     a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and     sterile sodium chloride in the control group. The aim of study is to investigate the effect     of a QL Block on the perioperative pain during postbariatric abdominoplasty.   "
25664|NCT02949765|"     Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of     patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good     compliance and clinical response to gluten-free diet. These patients are usually     premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not     balanced.      The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not     tolerated, and a dietary approach through a iron-rich diet in this subset of patients.   "
25665|NCT02949752|"     This is an open label study to prospectively evaluate the effect of adjunct use of     Aripiprazole, as an agent to improve metabolic profile and induce weight loss in patients     established on atypical antipsychotics (Olanzapine, Clozapine and Risperidone).   "
25666|NCT02949739|"     the investigators general goal is to identify approaches to risk stratification and health     promotion through lifestyle modification that are acceptable, effective and efficient for     prevention of T2D in South Asian communities from diverse settings.   "
25667|NCT02949726|"     The goal of this study is to find out which immune molecules, cells, and genes are involved     in the development of lymphedema (LE), so that medicines that target them can be considered     for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease     that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly     chemotherapy in genetically susceptible patients.   "
25668|NCT02949713|"     The primary aim of this study is to find out whether it is feasible to conduct a larger study     looking at the effect of mobile phone text messaging added to motivational interviewing on     number of women living with HIV infection reporting exclusive or any breastfeeding six months     post-delivery.      Secondary aim: In HIV-infected women initiating breastfeeding after giving birth, does     interactive weekly mobile phone text messaging plus motivational interviewing versus usual     care, improve self-reported adherence to exclusive or any breastfeeding 6 months     post-delivery   "
25669|NCT02949700|"     The purpose of this research is to see whether metformin can improve the response rate in     patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral     cavity, oropharynx, larynx or hypopharynx. The purpose of this research is also to see the     effects, good and bad, of metformin therapy for this disease. Researchers will also analyze     tumor and blood samples from study patients to test and understand the characteristics of     tumors which respond to metformin.   "
25670|NCT02949687|"     Surgical Treatment in Diabetic Patients With Grade 1 Obesity   "
25671|NCT02949674|"     Title: Ropivacaine versus Bupivacaine as Preventive Analgesia in Surgical Incision Site In     Patients With Ankle Fracture Background: Ankle fractures are about 10% of the fractures     associate to sports and with an incidence of 0.11 of 1000 adult patients. Weber     classification system divides ankle fractures in three types according to the anatomy of     lateral malleolus. B fractures starts at tibia pilon. Stable fractures are easily treated in     conservative way. (12) Unstable fractures are treated surgically with anatomic reduction and     internal fixation. However, it's been reported that even with successful reduction surgically     great results are not always achieved. Local wound infiltration blocks the pain in its     origin, surgical site by itself, without alter motor function. Practically without presenting     adverse events with this method. it´s accurate for ambulatory surgery.      Main Objetive: To compare preventive analgesia with local anesthetic in surgical site with     ropivacaine or bupivacaine in ankle fracture patients treated surgically with open reduction     and internal fixation.      Method: Two groups with ankle fractures which will be informed and the patients will sign     informed consent, after that the patients will be assign to a group (Ropivacaine or     bupivacaine). The patient will be prepared for surgical treatment according to his doctor. It     will be applied traditional anesthesia. It will be applied before beginning surgery in     bupivacaine group 25 mg and in ropivacaine group 37.5 mg at least 10 minutes before starting     surgery. After that the patient will have the traditional dose of analgesic treatment.The     group will evaluate the pain with VAS 0-10 at 4,8,12 and 24 hours after surgery. The group     will register data and will make statistic analysis. It will be elaborated the conclusion an     elaboration of a report.      Resources: The group counts with human resources of the group of investigators. The hospital     has in emergency department almost three patients with ankle fractures each day which require     surgical treatment. The hospital has x ray service to valuate the ankle fracture and with     computer system to analyze it. The hospital has the software for statistical analysis.      Experience: The group is formed with orthopedic surgeons with more than 5 years in treatment     of ankle fractures. Investigators have the support of pain medicine group in hospital and     with anesthesia coordinators. Investigators have a group of orthopedic residents which will     be encharged of ilfiltration wound site.      Time: September 2016 to February 2017.   "
25714|NCT02949102|"     The purpose of the research is to test whether a gymnemic acids (GA) lozenge will reduce     reward region response to intake of high-sugar food and ad lib candy intake and whether the     GA lozenge reduced reward region response to anticipated intake of high-sugar food and     high-sugar food pictures relative to a placebo lozenge.   "
25672|NCT02949661|"     Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with     tracheal stenosis or tracheal tumors .The postintubation tracheal stenosis is the common     indication for (TRR).The immediate postoperative period can be anxiety provoking for some     reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which     inadequately treated.      Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia     technique for its feasibility and efficacy. The use of regional anesthesia in combination     with general anesthesia may lighten the level of general anesthesia required , provide     prolonged postoperative analgesia and reduce the requirements for opioid analgesics      Local anesthetic infiltration into the surgical incision can relieve pain at the wound site     after surgery, as part of multimodal analgesic approach.      Levobupivacaine, is S-enantiomer of bupivacaine, has strongly emerged as a safer     alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be     equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically,     levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both     after bolus administration and continuous post-operative infusion.   "
25673|NCT02949648|"     A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive     evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong     Kong.   "
25674|NCT02949635|"     Three events can be considered of major importance for patients after a hospitalization in an     AGU: death, hospital readmission, and institutionalization. Current published data do not     allow the clinician to simultaneously estimate the risk of hospital readmission,     institutionalization and death of an older patient according to his/her characteristics and     various complications that occurred during the hospitalization. However, clinicians often     need to estimate these risks at hospital discharge to adapt their therapeutic choices, their     proposals post-hospital care, and provide reliable and fair information to the patient and     his relatives.      Estimating simultaneously the hazard for each of these three events can be complex. Indeed, a     death event hinder the observation of re-hospitalization or institutionalization if death     occurs before these events. The death should be considered a competing risk in these     analyzes. Hospital readmission may modify the risk of death or institutionalization and     should be considered as an intermediate factor for these event. This complexity cannot be     accounted with classical statistical models, like logistic regression models.      The purpose of this study is to use more appropriate statistical models (multi-state models)     to better estimate simultaneously the risks of hospital readmission, institutionalization,     and death of a patient given after hospitalization in AGU, and to show that accuracy of these     estimations can be improved by taking into account complications that occurred during the     stay in AGU.   "
25675|NCT02949622|"     The aim of this study is to identify the psychological, emotional and lifestyle variables     that can have an influence on the different components of metabolic syndrome (MetS) and     develop a program for change lifestyle in this patients.   "
25676|NCT02949609|"     After stroke, patients frequently suffer from arm or hand weakness. There are numerous     rehabilitation methods to stimulate recovery, amongst which mirror therapy (MT). It is     particularly interesting in cases for which impairment is severe, as many other forms of     therapy are often impossible.      During MT, a mirror is placed in the midsagittal plane, so as to hide the impaired limb.     Thereafter, the subject is asked to move his unimpaired limb while looking at its reflection     in the mirror, thereby creating the illusion that the contralateral, impaired limb is moving.      The objective of this study is to better determine the efficacy of MT. The investigators will     therefore compare recovery of arm function in two groups of patient, that perform a regimen     of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional therapy. One     group performs MT and the other one performs a therapy in which the same movements are     performed, but without the use of a mirror, with unrestricted view of both limbs. Allocation     to each group will be randomized. Arm function will be evaluated by use of a scale before,     during and after the 4 week period. The assessor for the primary outcome measure will not     know in which group the patient is. There will be a total of 30 patients included over a one     year study period.   "
25677|NCT02949596|"     Treatment of anal cancer has been always linked to quality of life. Recently, with     development on radiotherapy technique, toxicities have been lowered with the maintenance of     adequate rates of disease control. This trial intends to follow patients prospectively with     questionnaires to evaluate sexual quality of life among patients who are who men who have sex     with other men and have been subject to concurrent chemoradiotherapy with IMRT technique.   "
25678|NCT02949583|"     The mechanical control of supragingival biofilm is accepted as one of the most important     measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental     surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have     demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients     that prevent and control both supragingival biofilm and gingivitis, specially when used     adjunctively to mechanical oral hygiene regimens.   "
25679|NCT02949570|"     To assess the efficacy of inecalcitol in combination with imatinib in CML patients with     molecular residual disease on imatinib monotherapy.   "
25680|NCT02949557|"     DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has     the potential for osteoinduction due to increased expression of bone morphogenetic protein     (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct     bone defects. Decortication is performed as a part of guided bone regeneration (GBR)     procedure as it enhances the healing process.Therefore a combination of decortication and     bone graft when applied in periodontal intrabony defect would enhance the regeneration of     periodontium.   "
25681|NCT02949544|"     This study aims to investigate the effects of water immersion and exercise on heart function     and blood flow in patients with chronic stable heart failure.   "
25715|NCT02949089|"     This study intends to provide information on the safety and tolerability of repeated oral     doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study     of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best     address the study goals.   "
33703|NCT02844647|"     A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of     treatment with radium 223. Study participants will undergo anatomical MR imaging combined     with the new hyperpolarized MRI (1 hour exam) prior to treatment.   "
25682|NCT02949531|"     Oxygen is routinely given to patients with common conditions such as COPD and heart failure.     There is no evidence behind giving oxygen to patients specifically in heart failure due to a     stiff heart.      This study aims to explore the effect oxygen has on the ability of patients with chronic     heart failure and the ability to exercise. Other common variables will be assessed such as     heart rate and blood pressure to observe the response to varying concentrations of oxygen.      The concentrations chosen are commonly offered in hospitals and indeed are being delivered     through standard equipment found in all hospitals in the country.      It is hoped that studying the effect of short term oxygen on patients with heart failure will     help to identify the effectiveness of oxygen in longer term therapy for patients who are     often breathless with a decreased exercise tolerance.   "
25683|NCT02949518|"     Enhanced recovery after surgery (ERAS) pathways have been shown to decrease length of stay     and perioperative complications in a range of surgical specialties. To date, ERAS has not     been studied in patients presenting for spine surgery. The investigators have recently     developed an interdisciplinary pathway for spine surgery patients based on the latest     available evidence and guidelines. The aim of this trial is to compare the investigators ERAS     pathway with conventional perioperative management in patients undergoing 1-2 level posterior     lumbar fusion.   "
25684|NCT02949505|"     A UK prospective, single-centre feasibility study investigating the effects of exercise     therapy on functional capacity in patients on the waiting list for liver transplantation.     Patients will receive a 12-week home prehabilitation program (daily step program; functional     resistance exercise sessions; telephone health call or virtual clinic). The following will be     assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients     perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire)     and quality of life (EQ-5D)   "
25685|NCT02949492|"     Regulatory T cells (Tregs) suppress cytopathic immune responses and inhibit transplant     rejection. Our goal is to exploit the Treg suppressive properties to induce transplantation     tolerance. In contrast to effector T cells, Tregs constitutively express the high affinity     IL-2 receptor, which makes them exquisitely sensitive to very low-doses of IL-2. We propose     here to conduct a phase IV clinical trial in which we will test the capacity of low-dose IL-2     to promote the selective expansion of endogenous Tregs in liver transplant recipients at the     time immunosuppressive drugs are being discontinued. We expect this will promote Treg     accumulation within the transplanted liver, shift the balance between effector T cells and     Tregs, and facilitate the development of operational tolerance in patients unlikely to reach     this state spontaneously. We expect the trial to start shortly after the initiation of the     project and to provide robust evidence on the efficacy of IL-2 within 47 months.   "
25686|NCT02949479|"     Background: Adverse childhood experience have been described in sexual offenders but the link     with the offence need to be further investigated. Investigators postulate that one of the     clinical moderating factors could be dissociative experience, a consequence of these early     adverse experiences reactivated during the offence. The purpose of the study is to estimate     the prevalence of clinical dissociation during the offence in a male adult population     referred to our center for a sexual offence and to explore its correlations with     epidemiological and clinical data (personal, legal history, psychiatric comorbidities),     clinical trauma and dissociation, prognosis estimates.   "
25687|NCT02949466|"     Using a double-blind, randomized controlled design to investigate the additional therapeutic     effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of     hyaluronic acid injections to patients with knee osteoarthritis.   "
25688|NCT02949453|"     Background: Previous suicide attempt is known to be a strong risk factor for repetition and     repetition is common within the first year after an episode of deliberate self-harm (DSH).     There has been growing interest in brief interventions for this population that are focused     on maintaining long-term contact and/or offering re-engagement with services when needed.     Despite telephone-delivered interventions have shown promising results in suicide reattempt     prevention, subjective impact of such brief contact interventions and effectiveness     mechanisms have never been evaluated.   "
25689|NCT02949440|"     To investigate the clinical application value of laparoscopic radical right hemicolectomy     using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective     randomized controlled clinical study.   "
25690|NCT02949427|"     The human microbiome is composed of unique groups of microorganisms occupying distinct     habitats distributed throughout the human body. The Human Microbiome Project recently     evaluated the bacterial composition of the microbiome in 18 (for women) and 15 (for men) body     sites. Much initial attention in the field of microbiome research has focused on the     bacterial contribution to a healthy microbiome. However, it is clear that other     microorganisms, including fungi and viruses, are also distributed throughout the human body     and serve as functional components of the microbiome.      The populations of microorganisms residing within the oral and nasal cavities make important     contributions to human health and disease. These contributions may be especially important in     immunosuppressed patients, including those patients receiving myelosuppressive chemotherapy     or undergoing hematopoietic stem cell transplantation. In these patients, organisms typically     considered as commensals can become pathogenic, either locally or systemically.      This observational study is primarily undertaken to evaluate the oral and nasal microbiota     and to define the population of fungal organisms residing within the oral and nasal cavities     in pediatric oncology patients before and after receiving protocol-directed chemotherapy and     associated supportive care.   "
25691|NCT02949414|"     This is a phase I study to evaluate the safety, efficacy and tolerability of a novel tracheal     replacement therapy using cadaveric de-cellularised tracheal scaffold and patients' own     mesenchymal cells isolated from a sample of their bone marrow in patients' who suffer from     severe tracheal malacia or stenosis.   "
25729|NCT02948907|"     Several benign and malignant diseases are associated with hilar and mediastinal     lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the     visualization of tissue elasticity and Tissue Harmonic Imaging (THI) might be useful for     the differentiation of benign and malignant lymph nodes.   "
25936|NCT02946203|"     In this research study, two different oral contrast materials that can be used for CT or MR     enterography will be studied. This study is designed to compare which oral contrast material     (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality     exams.   "
25693|NCT02949375|"     Primary objectives:      To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28,     following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic     liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of     liver inflammation.      To assess the safety and tolerability of GRI-0621 at these two doses.      Secondary objectives:      To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28,     following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic     liver disease and elevated serum levels of AST. Serum AST level will be used as a second     marker of liver inflammation.      To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in     serum ALT levels from baseline measured at the different trial time points.      To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following     daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver     disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or     apoptosis.      To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28     following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.      To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic liver     disease.      Exploratory objectives:      To assess the effect, if any, that the investigational product may have on serum triglyceride     levels.   "
25694|NCT02949362|"     The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of     children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term     period. It will evaluate how these children fared after the TED-C13-003 study ended. This     study will also offer teduglutide treatment to eligible subjects, regardless of treatment     received in TED-C13-003.   "
25695|NCT02949349|"     This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate     Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the     maintenance therapy of lupus nephritis.   "
25696|NCT02949336|"     The proposed study is a prospective collection of health related personal data (observational     study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance     Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial     Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance     and swing phase of level walking, downhill walking (ramp descent) and stair descent at least     12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well     as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the     video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich.     The UKA subjects are recruited based on the inclusion and exclusion criteria.      The primary objective is to quantify and describe the three-dimensional kinematics for     patients with a traditional medial SIGMA® High Performance Partial Knee System (functional     ACL and tibial posterior slope matching the native bone) during these daily activities.      The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High     Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a     50% reduced tibial posterior slope relative to the native knee.   "
25697|NCT02949323|"     The incidence of nephrolithiasis in children has been reported to increase by approximately     6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent     rate. Investigators aimed to determine the metabolic risk factors in Chinese children through     metabolic evaluation.      In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western     country wether adapt to Chinese children, investigators aim to determine normal urine levels     of oxalate and citrate in children without kidney stone.   "
25698|NCT02949310|"     Breast cancer surgery is known to cause severe acute postoperative pain, which can persist     for a long time. The investigators administered nefopam preventively to patients undergoing     total mastectomy or modified radical mastectomy with axillary lymph node dissection or     sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative     pain.   "
25699|NCT02949297|"     A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent     Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).   "
25700|NCT02949284|"     This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works     with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone     in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause     the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist     ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may     fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may     either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist     ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in     treating patients with prostate cancer.   "
25701|NCT02949271|"     The aim of this prospective, doubled-blinded randomized study is to compare two modes of     epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus     continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing,     for providing labor epidural analgesia. The primary outcome will be the volume of local     anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus,     labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of     successful to unsuccessful attempts, frequency of hypotension, duration of first and second     stages of labor and level of patient satisfaction. The investigator plans to enroll 120     nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The     subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1%     with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be     analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be     analyzed using Chi-square test or Fisher's exact test as appropriate.   "
25702|NCT02949258|"     Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive     tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant     chemotherapies have not improved the survival rate. The purpose of this study is to determine     whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous     administration are effective in the treatment of Borrmann type 4 gastric cancer.   "
25703|NCT02949245|"     272 subjects with high risk adult spinal deformity requiring surgical correction were     enrolled in the previous prospective multi-center international Scoli-RISK-1 study. High     risk patients were defined by either their diagnoses and/or the type of surgical     intervention as listed in the inclusion criteria. Neurological complications in the form of     new motor and sensory deficits were monitored prospectively in all patients at hospital     discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the     surgery. The relationship to the surgical intervention was assessed in all new deficits.      Regression analyses were used to evaluate the association between patient demographics,     co-morbidities, treatment history, spinal deformity characteristics, surgical     characteristics, non-neurologic complications and pre-surgical status to occurrence of a     neurologic deficit after surgery.      All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year     FU visit.   "
25704|NCT02949232|"     Treatment with prednisolone can be used as a proof of concept to investigate the possibility     of immune modulation as a treatment for schizophrenia. It is expected that daily treatment     with prednisolone in addition to antipsychotic treatment reduces psychotic symptoms and     improves cognition, as compared to placebo. The investigators propose to investigate the     effects of administering the corticosteroid prednisolone versus placebo in addition to     standard antipsychotic medication in patients with early stage schizophrenia or related     disorders, hypothesizing that a decrease in the overall low-grade cerebral inflammation due     to prednisolon treatment will be expressed as a decrease in overall symptom severity.,     Secondly, addition of prednisolone is hypothesised to slow down cognitive deterioration in     recent-onset psychosis patients. Finally, the investigators aim to determine whether indirect     immunological parameters of the hypothesised low grade inflammation status in schizophrenia     are shifted due to the addition of prednisolone.   "
25705|NCT02949219|"     This phase II trial studies how well pembrolizumab works in treating patients with small     bowel adenocarcinoma that has spread to other places in the body or that cannot be removed by     surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of     tumor cells to grow and spread.   "
25706|NCT02949206|"     The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1     (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of     JNJ-64179375 induced Pharmacodynamic effects on coagulation parameters and platelet function     (Part 2) in healthy male participants.   "
25707|NCT02949193|"     This is a randomized, double-blind, active-controlled, phase III clinical trial to     investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy     in patients with type 2 diabetes who have inadequate glycemic control   "
25708|NCT02949180|"     Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App     in a prospective cohort.   "
25709|NCT02949167|"     Approximately 24,000 women attend a follow-up care program after end of primary treatment for     breast cancer (BC) in Denmark. There is no well-conducted, larger randomized controlled     trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of     recurrence, good management of symptoms and cost-effectiveness. The primary aim of this     randomised, controlled trial is to test whether a nurse-led individually tailored symptom     management program (MyHealth) will significantly reduce reported symptoms among BC patients     following primary treatment compared to physician-led scheduled follow-up. Secondary, the     investigators will examine patient activation (self-management), anxiety, depression, fear of     recurrence, work ability, time to recurrence, health behavior changes, health care     utilization and financial costs in the two arms.      The MyHealth program provides patients with a nurse-led education focusing on management of     symptoms, an electronic platform to report symptoms to the nurses and support in symptom     management and navigation of patients to appropriate health care services.   "
25710|NCT02949154|"     A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.   "
25711|NCT02949141|"     This study is designed to evaluate the use of lung ultrasound compared to chest x-ray to     diagnose pneumonia in Nepal. Given the ease, portability, and relative ease of teaching     ultrasound, this would be potential technology available for many clinicians throughout Nepal     to use for adult and pediatric patients presenting with suspected pneumonia. This would be     especially useful in remote areas where clinicians have limited access to x-rays. Despite its     utility, use of ultrasound to diagnose pneumonia in resource-limited settings like Nepal has     not yet been studied. Therefore, this study is designed as a prospective, clinical diagnostic     study to evaluate patients presenting with suspected pneumonia using diagnostic imaging of     beside ultrasound compared with chest x-ray using computed tomography as the gold standard     for diagnosis of pneumonia.   "
25712|NCT02949128|"     The purpose of the study is to assess the efficacy of ALXN1210 to control disease activity in     adolescent and adult patients with aHUS who have not previously used a complement inhibitor.   "
25713|NCT02949115|"     Aside from aging, numerous factors increase the risk for developing cardiovascular disease     (CVD) including diet and nutrition. High-fat meal consumption induces postprandial vascular     endothelial dysfunction and other cardiometabolic disturbances (e.g. dyslipidemia and     hyperglycemia) in normal weight individuals and is exacerbated in overweight/obese     individuals. These postprandial responses are likely largely due to activation of     pro-inflammatory and pro-oxidant pathways. Given that much of the day is spent in the     postprandial state, this may further impair cardiovascular health in aging overweight/obese     individuals. Interventions that attenuate these responses are needed. Red beetroot (Beta     vulgaris L.) is an excellent source of bioactive compounds including nitrate, flavonoids,     phenolic acids, betalains, carotenoids, and ascorbic acid. These bioactive compounds and     their metabolites have been shown to have antioxidative, anti-inflammatory, and     cardiovascular-protective effects. These effects, particularly the cardiovascular-protective     effects, have been primarily attributed to its high content of nitrate since it is converted     to nitric oxide independent of the vascular endothelium via the enterosalivary     nitrate-nitrite-nitric oxide pathway. However, red beetroot juice contains a number of other     potentially beneficial bioactive compounds and few studies have aimed to determine whether     these compounds work independently, additively, or synergistically in exerting these effects.     Given the findings of previously conducted research in the broad area of red beetroot juice     consumption and human health, it can be suggested that: 1) acute red beetroot juice     consumption may prevent or attenuate the adverse postprandial responses to consuming a     high-fat meal in individuals with exaggerated responses; and 2) chronic consumption of red     beetroot may improve underlying factors contributing to these exaggerated responses.     Accordingly, this project aims to: 1) investigate the efficacy of acute and chronic whole red     beetroot juice consumption compared with its bioactive components in attenuating postprandial     vascular endothelial dysfunction and adverse cardiometabolic responses to a high-fat meal;     and 2) to gain insight into the underlying mechanisms responsible.   "
26074|NCT02944409|"     This post-market clinical follow-up study intends to investigate long-term functionality of     the VEGA System®. The design of the VEGA System® is meant to provide the patient with more     knee mobility compared to their pre-operative state.The endpoint is the revision of at least     one of the prosthesis components   "
25716|NCT02949076|"     Cancer and its treatment can have profound effects on skeletal muscle, the most     well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations     negatively impact quality of life, treatment decisions and survival. Despite these     consequences, the factors promoting these adaptations remain poorly defined and understudied     in human patients. To address this gap in knowledge, our goal in this study is to examine the     role of muscle disuse as a regulator of muscle size and function in human cancer patients   "
25717|NCT02949063|"     A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led     Comfortable Cafeteria program designed to build capacity of cafeteria supervisors to create a     positive mealtime environment so that all students can successfully participate in and enjoy     their meal and socialization with peers.   "
25718|NCT02949050|"     Patients demonstrated allergic to corn pollen and timothy grass pollen (by allergy testing)     who have undergone 1 to 2 years of subcutaneous allergen immunotherapy (SCIT) containing     timothy grass extract with moderate symptomology (as documented via rhinitis symptom score     surveys) will constitute the treatment group. Those who previously chose not to undergo SCIT     who have documented symptomology and are skin test positive to corn pollen will constitute     the control group. Prospective symptom score analyses and retrospective quality of life     assessments (RQLQ) will be the primary and secondary efficacy outcome measures.   "
25719|NCT02949037|"     Multi-site feasibility study designed to assist type-2 diabetes patients in self-care     activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood pressure     cuffs, glucometers, and activity monitors) for both intervention and control groups. Those in     the intervention group will have the devices linked too a mobile health care environment that     provides key benefits that include: device data trending, reinforcing tailored behavioral     messages, and enhanced communication with the clinic.   "
25720|NCT02949024|"     This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA     alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema     associated with diabetes mellitus.   "
25721|NCT02949011|"     The primary objective of this study is to evaluate the efficacy of a single, oral dose of     S-033188 compared with placebo by measuring the time to improvement of influenza symptoms in     patients with influenza presenting within 48 hours of symptom onset.   "
25722|NCT02948998|"     Hypertrophic Cardiomyopathy (HCM) is the most common hereditary heart disease with high     mortality. Heart failure is the most common complication (about 50% incidence) in these     patients. However, it is lack of efficiency medicine to treat heart failure for HCM patients.      Recent studies found fibrosis was common in HCM patients and it was progressive with aging.     Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to     measure the left ventricular(LV) fibrosis extent and been proven to be useful in HCM     patients.      Aldosterone plays an important role in the development of fibrosis. Meanwhile, a few studies     suggested that aldosterone might participate the development of fibrosis in HCM patients.     Spironolactone, a mineralocorticoid receptor antagonist, has been proven its effect on     inceasing the survival of the heart-failure patients with the eject fraction lower than 35%.      Thus, the investigators hypothesize that fibrosis is one important reason of heart failure     for HCM patients. The purpose of this study is to investigate whether small dosage and early     prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis     progress and improve patients' symptoms.      This study is a multicenter, randomized, controlled and open-label study being conducted in 4     centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy of     spironolactone on relieving the LV fibrosis in HCM patients. This study plans to recruit 260     participants with definite HCM diagnosis. Then these participants will be randomized to two     groups-- control group (not taking spironolactone) and spironolactone group (taking 20mg     spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter,     electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium, liver     enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random allocation     and after 2 years. LGE-CMR will be used to measure the extent of fibrosis in LV. The extent     of LGE+% (the area showing LGE divided by the total area) before and after 2-year experiment     and the increase of LGE+% after 2-year experiment will be compared between control and     spironolactone groups. Meanwhile, symptoms, New York Heart Association classification of     cardiac function, arrhythmia, proBNP and TnT etc. will be compared between two groups.   "
25723|NCT02948985|"     Evaluation of individual peripheral blood circulating tumor cells combined with tumor marker     detection of efficacy of chemotherapy in patients with advanced colorectal cancer: A     observational clinical trial   "
25724|NCT02948972|"     The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial.     This study includes patients presenting colorectal DIE and infertility. Patients will be     randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE     prior to ART and the other group underwent ART alone (ratio 1:1)   "
25726|NCT02948946|"     The purpose of this study is to evaluate how well an investigational blood test performs. The     study will look at the sensitivity and specificity of a blood-based multitranscriptome assay     (NETest).   "
25727|NCT02948933|"     The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the     real-world immunization setting      Primary Objective:        -  To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs)          occurring over a period of six (6) months after each Dengvaxia® dose administration;        -  To quantify the association between Dengvaxia® and each of the selected AEs and SAEs for          which a risk window after vaccination can be defined, using estimates of relative risk        -  To monitor the occurrence and frequency of hospitalized dengue disease as well as any          other SAEs leading to hospitalization or death, including new and previously          unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years          after the first Dengvaxia® dose administration.      Secondary objectives:        -  To identify risk factors for hospitalized dengue disease (severe or not) among subjects          vaccinated with Dengvaxia®;        -  To describe the frequency of hospitalized dengue disease and/or other SAEs or selected          AEs according to the number of Dengvaxia® doses and/or interval between doses.   "
25728|NCT02948920|"     A prospective double-blinded randomized controlled study to determine efficacy of ephedrine     in preserving core temperature in patients under neuraxial spinal anesthesia for knee     arthroscopic surgery.   "
25743|NCT02947698|"     Increased in-hospital mortality associated with weekend admission has been reported for many     acute conditions, but no study has investigated weekend effect for acute kidney injury     requiring dialysis (AKI-D). In this study, the investigators compared mortality in AKI-D     patients admitted on weekday versus weekend and assessed factors associated with increased     mortality.   "
25744|NCT02947685|"     The primary objective of this study is to demonstrate that the combination of palbociclib     with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus     endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive,     HER2+ metastatic breast cancer.   "
25730|NCT02948894|"     Primary aim: The MOSAIC trial aims to assess the impact of a mandibular advancement device     (MAD) on Apnea-Hypopnea Index (AHI) in Asian patients with Heart Failure with reduced     Ejection Fraction (HFrEF) and obstructive sleep apnea (OSA). The investigators hypothesize     that the AHI was 60% lower after 3-month treatment with MAD than with sham MAD.      Secondary aims: The investigators also aim to determine i. the interaction between ethnicity     (Chinese, Malay, Indians) and the effects of MAD in lowering AHI; ii. the effect of MAD on     cardiac remodeling (LVEDVI assessed by cardiac magnetic resonance imaging [CMR]); iii. the     characteristic craniofacial skeletal anatomy (using coned beam computed tomography [CT])     associated with OSA in Asian patients with HFrEF; iv. the association between self-reported     adherence to MAD and cardiac remodeling; v. the effects of MAD on biomarkers of HF     (N-terminal pro-B-type natriuretic peptide [NT-proBNP],high sensitivity cardiac troponin T     [hs cTnT], high-sensitivity C-reactive protein [hs-CRP], and ST2);      Rationale: OSA is associated with incident HF. The investigators will study Asian patients     because a body of evidence suggests mechanisms for OSA differ between Asians and Caucasians.     While obesity is the major contributing factor in Caucasians, craniofacial skeletal anatomy     (short mandible, maxilla, and cranial base and a large mandibular volume) plays an important     role in the development of OSA among Asians. Using cone beam CT, it has been shown that     Asians have shorter mandibular, maxillary, and cranial base lengths and a greater mandibular     volume compared with Caucasians. Using a MAD to adjust maxillary-mandibular juxta-positioning     to maintain a patent airway may be an ethnic-specific approach to treat OSA in Asians.   "
25731|NCT02948881|"     The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken     once monthly versus placebo on bone quality and strength at the hip at one year.   "
25732|NCT02948868|"     This study will correlate MA-abstinence outcomes from an 8-week contingency management (CM)     program of voucher- based incentives using an escalating schedule that has been successfully     implemented as an adjunct to MA treatment by the investigators collaborators in the United     States. Pre- and post- treatment neuroimaging and neurocognitive assessments will assist in     identifying structures and/or processes that may represent targets for development of novel     behavioral and/or medication therapies.   "
25733|NCT02948855|"     Initially investigators will find LncRNA which to be able to affect Notch2 signaling pathway;     then confirm the relationship between Notch2 and LncRNA, and analysis the regulation mode of     LncRNA to Notch2 signaling pathway, and to observe the correlation between LncRNA and thymoma     complicated with autoimmune diseases.   "
25734|NCT02948842|"     The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase     (XIAFLEX®) in treating urethral strictures.   "
25735|NCT02948829|"     The purpose of this study is to assess the cellular immune responses following 2 doses of     tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.   "
25736|NCT02948816|"     Participants will be exposed to 3 conditions, in random order:        1. A Facebook page where 70% of posts are related to food.        2. A Facebook page where only 20% of posts are related to food.        3. A control condition (colouring quietly).      During each of the above conditions participants will be provided with identical snacks. The     snacks will be weighed before and after each condition, to determine whether there is a     change in food intake across the 3 conditions.   "
25737|NCT02948803|"     The aim of this smartphone-based intervention study is to determine whether a newly developed     app is effective in promoting an active lifestyle in low educated working young adults.   "
25738|NCT02948790|"     The aim of this study is to assess the auditory nerve functionality with an intraoperative     approach following a surgical removal of acoustic neuroma in patients with severe to profound     sensorineural hearing disabilities.   "
25739|NCT02948777|"     Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal fasting     triglyceride values. Humans are mostly in a postprandial rather than in a fasting state and     therefore non-fasting triglyceride values reflect more accurately the continuous exposure of     arterial wall to the substantial cholesterol load. Evolocumab lowers blood LDL-cholesterol.     This study evaluates the effect of evolocumab on postprandial lipid metabolism in type 2     diabetes. All participants in this study receive evolocumab treatment.   "
25740|NCT02948764|"     The main purpose of the study is to evaluate the potential of a minimal invasive,     vacuum-assisted biopsy (VAB) to reliably diagnose a pathological complete response (pCR) in     the breast after neoadjuvant chemotherapy (NACT) in breast cancer patients.      The study is designed as a multicenter, confirmative, one-armed,     intra-individually-controlled, open, diagnostic trial, in which we aim to confirm the     applicability of preoperative VAB in patients after NACT. Furthermore, we aspire to quantify     the rate of concordant pathological findings (pCR yes / no) in biopsy and surgical specimen.   "
25741|NCT02947724|"     Two hundred women aged from 20 to 35 years undergoing conservative laparoscopic treatment of     ovarian endometriomas (either by drainage or cyst wall excision) were included. Participants     were randomized into 4 groups; group A (drainage only) in which 50 patients underwent     laparoscopic fenestration and electrocautery of the endometrioma cyst wall, group B     (cystectomy only) in which 50 patients underwent laparoscopic excision of the endometrioma     cyst wall, group C (drainage & Surgicel) in which 50 patients underwent laparoscopic     fenestration of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel     inside the cyst cavity, group D (cystectomy & Surgicel) in which 50 patients underwent     laparoscopic excision of the endometrioma cyst wall followed by insertion of 4 pieces of     Surgicel inside the remaining ovarian tissues.All patients were followed up every 3 months     for 2 years following the laparoscopic surgery. The primary outcome was the recurrence of     endometriomas in the ipsilateral ovary (recurrence was defined as the presence of ovarian     cysts with the characteristic sonographic features of endometriomas (≥1 cm). The ovarian     reserve was reassessed (AMH & day 2 AFC) as a secondary outcome 6 months following the     laparoscopy.   "
25742|NCT02947711|"     This Phase 1, open-label, single-sequence, drug-drug Interaction study is conducted to     evaluate the effect of diltiazem extended release (ER) (a moderate CYP3A inhibitor and P     glycoprotein [Pgp] inhibitor) on the pharmacokinetics (PK) of a single oral dose of E2027 in     healthy participants.   "
34327|NCT02836470|"     The purpose of this study is to establish preliminary evidence of the efficacy, safety, and     tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal     adhesions in subjects undergoing elective bowel resection.   "
25746|NCT02947659|"     [Purpose] To investigate the prevalence of musculoskeletal disorders among healthy students     of Ahlia University and to determine the relationship between the prevalence of     musculoskeletal disorders and academic stressors and body mass index. [Subjects and Methods]:     Self-administered questionnaires were distributed to 94 students aged 18-26 years who were     enrolled at various Ahlia University colleges and met other inclusion criteria. The students     responded to the standardized Nordic musculoskeletal questionnaire and the modified College     Student Stress Inventory regarding musculoskeletal symptoms and academic stressors. Height     and weight measurements were also obtained to determine body mass index.      Keywords: Body mass index, Academic stress, Musculoskeletal disorders   "
25747|NCT02947646|"     This is a pilot, randomized, safety and efficacy study of an investigational device (i.e.     BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain     subject feedback, assess device performance; and ascertain potential harm in healthy adult     volunteers.   "
25748|NCT02947633|"     The purpose of this research is to compare the effect of single-injection sciatic PNB to     continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain     scores, pain medication use, and unplanned hospital admission due to poor pain control, 2)     active knee flexion, and 3) patient satisfaction with pain control following ACL     reconstruction with a hamstring autograft. The results of this research have the potential to     positively impact pain control for the adolescent population undergoing this surgical     procedure and foster responsible utilization of limited resources.   "
25749|NCT02947620|"     A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the     safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and     dyslipidemia.   "
25750|NCT02947607|"     The purpose of this study is the investigation of new host-microbiome interactions promoting     adenoma formation and adenocarcinoma progression. For that purpose, the investigators will     collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or     surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and     medical history will be collected. Sample analysis will involve simultaneous characterization     of host and microbiota genomic and transcriptomic components.   "
25751|NCT02947594|"     Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications     resulting from administration of parenteral nutrition in neonates. Excess intravenous intake     of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major     contributing factor. To date, no information is available on plasma phytosterols half-lives     in very-low-birth-weight (VLBW) preterm infants with PNAC. In a prospective cohort study,     plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants with     PNAC will be measured by gas chromatography-mass spectrometry (GC-MS) during PN     administration and also after the stop of intravenous lipid infusion. Plasma phytosterols     half-lives will be calculated from the monoexponential decay curves. Blood samples will be     weekly collected from 1st to 12th week of life during routine metabolic tolerance analysis or     gas-analysis in order to avoid burden of additional phlebotomy. Samples will be collected in     ethylenediaminetetraacetic acid-tubes and immediately centrifugated. Plasma will be stored in     pyrogallol added-tubes at -20°C until analysis. Saponification reaction will be done using     5-alpha-cholestane as internal standard.   "
25752|NCT02947581|"     Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological     disease in most of the world. When parasites locate in the cavities around the brain     (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal     presentation. Current treatment regimens for SANCC have quite limited efficacy. The     investigators propose to compare the current standard of care (a single antiparasitic drug,     albendazole) with a combined regimen using two antiparasitic drugs simultaneously by adding     praziquantel. The trial will enrol 164 patients in four centers, two in Peru, one in Ecuador,     and one in Brasil.   "
25753|NCT02947568|"     The present study investigates relationship between non-alcoholic fatty liver disease and its     risk factors, such as genetic background and diseases, such as chronic kidney disease and     diabetes mellitus.   "
25754|NCT02947555|"     The rate of lens autofluorescence will be compared in diabetic and non diabetic patients     with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk     of cardiovascular diseases.   "
25755|NCT02947542|"     There is no evidence from prospective randomized clinical trials regarding the performance of     conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive     coronary angiography over the radial access.      The aim of the present trial is to evaluate the efficacy and safety of different one-catheter     concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins     catheters in diagnostic coronary angiography via transradial access. Patients with stable     angina pectoris will be randomly assigned to coronary angiography performed with the BLK or     Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography     duration.   "
25756|NCT02948738|"     Children with asthma are admitted for asthma attacks very frequently in the U.S. The families     and children are given basic education about asthma but studies are needed to improve this     education so that it makes a meaningful difference in health outcomes and asthma care. This     study compares two inpatient education models for children hospitalized with asthma.   "
27973|NCT02919592|"     The purpose of this study is to collect additional post-approval clinical data on the     long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary     or revisional breast augmentation and primary or revisional breast reconstruction.   "
25757|NCT02948725|"     Based on the current state of knowledge and gaps in the literature we will conduct an     intervention study to explore novel treatment and rehabilitation of patients at Royal     University Hospital (RUH) with motor deficits following stroke. This project has the     following objectives:        1. To determine if cross-education, in addition to standard rehabilitation leads to better          recovery of upper limb function for stroke patients with hemiparesis.        2. To incorporate functional brain activation as measured by functional magnetic resonance          imaging (fMRI) to examine the neural mechanisms associated with changes in motor          function of the paretic arm post-stroke.        3. To use diffusion tensor imaging (DTI) tractography to measure connectivity and examine          the extent to which white matter tract thickness correlates with preserved motor output          in patients post-stroke.   "
25758|NCT02948712|"     The purpose of this study is to help adolescents and young adult cancer survivors address     their psycho-social needs during the transitional period. The transitional period begins at     completion of cancer treatment and continues throughout that first year. Patients often     report this period can be difficult and distressing in many areas of life. This study will     use a simple tool to measure, on a regular basis, the level of distress a young adult may be     feeling. Based on this assessment additional mental health support and intervention can be     recommended to help cancer survivors cope and enhance their feelings of well-being.   "
25759|NCT02948699|"     The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce     the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition     conditions and clinical outcomes of patients. This research tries to evaluate the nutrition     status at the baseline, before and after radiotherapy, during the follow-up by the body mass     index, hematological indexes, immunological indexes, and nutrition questionnaires including     PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the     investigators aim to find an optimized assessment model and the best nutrition support     patterns.   "
25760|NCT02948686|"     Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,     that aims to evaluate the best application strategy when using a new Universal Adhesive     system, Ambar Universal (FGM, Joinville, Brazil). Volunteers will be selected and     recruited,following inclusion criteria and pre-established exclusion. All volunteers will be     informed and sign a term of clarification and consent. 38 enrolled patients will receive four     Class V dental restorations, made in four different ways, one from each experimental group,     using the same universal self-etching adhesive system, which is the tested material in this     study. Non-carious cervical lesions will receive the applied adhesive system in 4 different     protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the     adhesive system will be used in 55 teeth, according to the manufacturer's instructions, in     the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity,     will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10     seconds and activated during 10 seconds with Light Emission Diode (LED) light; Group SEE     (Selective enamel etching): 37% phosphoric acid will be applied during 15 seconds, only in     enamel in 55 teeth. This acid will be removed using water, the cavity will be air-dried, and     then, the adhesive will be applied according to the manufacturer's instructions, as described     in group SET; Group SETT (Self-Etching with extended time): Similar to Group SET, but during     the 2 applications, the adhesive systems will be brushed during 20 seconds, and not during 10     seconds as described in Group SET; Group SETL (Self-Etching with extended number of layers):     The adhesive system will be applied as describe in Group SET, but the researchers will apply     4 layers, and not 2 layers, as described in Group SET. After applying the adhesive, the     restorations will be made with composite resin, and evaluated every 6 months for pain     assessment, shape, staining or recurrent caries, using scores. To determine in which group     each tooth will be enrolled, the authors will randomize the teeth.   "
25761|NCT02948673|"     Objectives: The research focus of the study is the production of reactive oxygen species     (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation     and in response to acute exercise.      Oxidative stress is suggested as a possible causative factor in the pathophysiology of     skeletal muscle insulin resistance. GSH is the most abundant endogenous antioxidant in the     cell and thus, a crucial protector against oxidative stress and insulin resistance. It has     been found that patients with T2D have a decreased level of GSH in plasma and that 1 h GSH     infusion improves skeletal muscle glucose uptake by ~25% and the redox environment in     patients with T2D. Therefore, we want to investigate the effect of 3 months of GSH     supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in     patients with T2D and healthy controls.      Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in     patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in     the skeletal muscle.      In contrast to the link between oxidative stress and insulin resistance, ROS produced in     response to exercise is an important physiological stimulus as it is suggested to play a key     role in the beneficial mitochondrial biogenesis observed in response to training. It has been     reported that some patients with T2D have a diminished mitochondrial biogenesis in response     to training, but the reason for this defect is not known. We want to investigate the link     between exercise-stimulated ROS production and the mitochondrial biogenesis response in     patients with T2D and healthy controls in response to acute exercise at two different     intensities.      Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic     ROS level), we speculate that a lower exercise intensity, leading to a lower     exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for     mitochondrial biogenesis in patients with T2D.   "
25762|NCT02948660|"     The research contains three parts. Part 1: To explore the evaluating and prognostic values of     electroencephalography sleep cycle combined with the serum melatonin and orexin level of     patients with disorders of consciousness; Part 2: To assess the efficacy of the     wake-promoting function of zolpidem tartrate in comotase patients; Part 3: To assess the     efficacy of the wake-promoting function of melatonin in comotase patients.   "
25763|NCT02948647|"     This dietary intervention aims at developing a more personalized and targeted treatment for     NAFLD in Hispanic children and adolescents who are GG for the PNPLA3 variant. The     investigators previous publications have shown that this particular demographic has a greater     than 2-fold higher liver fat compared to GC and CC individuals. They have also demonstrated a     significant gene*dietary sugar interaction with a significant association between liver fat     and dietary sugar intake in GG subjects with no such association in GC or CC individuals.     These studies suggests that different dietary strategies may have differential effects on     reducing liver fat, depending on PNPLA3 genotype. To confirm this, the investigators will     complete a clinical trial in 120 overweight and obese Hispanic children (12 - 18 years) with     clinically verified NAFLD who will be randomized to one of two 12-week interventions:      Group 1 (standard of care control group): Dietary intervention focused on healthy eating     (n=60; 30GG + 30GC/CC)      Group 2 (standard of care + sugar reduction): Dietary intervention based on healthy eating     and sugar reduction focused on reduction of sugary beverages and added sugar towards a goal     of 10% of daily calories (n=60; 30GG + 30GC/CC)      The following outcomes will be measured before and after intervention: Total liver fat     fraction, and visceral and subcutaneous abdominal adipose tissue volume by magnetic resonance     imaging (MRI); liver fibrosis by magnetic resonance elastography (MRE); total body fat by     DEXA; liver enzymes, fasting insulin, glucose, lipids, free fatty acids and inflammatory     markers, gut microbiome, and insulin and glucose response to an oral glucose challenge. The     investigators hypothesize that liver fat fraction, liver fibrosis, and metabolic outcomes,     such as fasting and 2h-glucose and insulin, and inflammatory biomarkers, will show     significantly greater improvements with sugar reduction relative to control. In addition, the     investigators also hypothesize a treatment*genotype interaction whereby the reduction in     liver fat will be significantly greater in GG relative to CC/CG subjects.   "
25764|NCT02948634|"     The purpose of this study is to examine the use of low level therapeutic laser (LLLT) for its     effects on pain, fatigue, and physical function in individuals with fibromyalgia.   "
25765|NCT02948621|"     The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal     suture approach without any incision. It could reduce the complications associated with     current surgical techniques while obtaining the target gastric restriction, weight loss,     comorbidities and quality of life improvement.      The primary objective of this study is to assess weight loss after endoscopic sleeve     gastroplasty in patients with morbid obesity.   "
25766|NCT02948608|"     The objective of the study is to investigate extra-articular manifestations, pain mechanisms,     patient-reported outcomes, comorbidities and association between these conditions in patients     with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive     value of baseline pain profile on treatment outcome after ≥ 3 months.   "
25767|NCT02948595|"     The long term goal of our research is to develop a curriculum for Obstetrics and Gynecology     resident physicians that regularly employs use of video assessment to improve surgical     skills. Regular use of video feedback may enable improved self-assessment and allow for     formal documentation of proficiency. The overall objective is to compare the use of video     feedback to use of structured verbal feedback in the simulated task of laparoscopic vaginal     cuff closure.   "
25768|NCT02948582|"     The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate     Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow     nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient     randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2     weeks. After the dose was given, lung airflow was measured over 24 hours and blood was     collected to measure how much GIS was in the bloodstream. The study was conducted to find the     once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow     nebulizer.   "
25769|NCT02948569|"     Metabolic syndrome increases the risk for development of heart disease. Another condition     associated with metabolic syndrome is fatty liver disease which is also referred to as     nonalcoholic fatty liver disease (NAFLD). Recently, drugs that block fatty acid synthesis     have been developed to treat cancer. These drugs are now being considered for the treatment     of NAFLD. A research test designed to measure liver fatty acid synthesis involves consumption     of a sugary solution and measurement of blood fats over a six-hour period. The present study     will test the drug 3-V Bioscience-2640 in healthy subjects with characteristics of the     metabolic syndrome before and after 10 days of treatment to determine if 50 mg/d     significantly reduces liver fat synthesis and lowers liver fat storage.   "
25770|NCT02948556|"     The purpose of this study is to identify daily activity patterns, negative life events and     autonomic abnormalities that may be related to non-improvement in myalgic     encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and     behavioral intervention trials, roughly 50% of patients report worsening or unchanged     illness. The proposed four year study would be the first to look at the relation between     illness non-improvement, patient activities at home and autonomic function. Our long-range     goal is to identify physiological signals and activity patterns that predict non-improvement     and relapse and develop a self-management program that prescribes improvement-linked     behaviors and discourages non-improvement activities.   "
25771|NCT02948543|"     Open label, randomised phase 3 trial of the addition of Mitomycin C to BCG as adjuvant     intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to     compare disease-free survival between treatment arms: BCG alone versus Mitomyicn C in     addition to BCG.   "
25772|NCT02948530|"     Classically lung elastance and transpulmonary pressure are measured from the difference in     tidal variations of airway pressure subtracted by tidal variations i esophagus pressure     divided by the tidal volume. This requires the presence of a esophageal balloon catheter     which is cumbersome and costly. In this study values obtained as described above are compared     to values obtained with a new method in which a stepwise increase in positive endexpiratory     pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the     tidal volume which the patient is ventilated with. The measurements are performed in sedated     and mechanically ventilated patients in the intensive care unit.   "
25773|NCT02948517|"     Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining     the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is     effective for weight loss and cardio-protection in obese adults. It is of great interest to     see whether subjects can adhere to TRF for longer periods of time, and to see what degree of     weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To     determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To     determine if TRF can produce clinically meaningful reductions in plasma lipids, blood     pressure, insulin resistance, and inflammatory markers.   "
25774|NCT02948504|"     Intracranial aneurysms are common in the general population. The overall prevalence of     unruptured intracranial aneurysms (UIAs) is estimated of 2.3-3.2% in the population without     specific risk factors for SAH. As noninvasive imaging modalities are more commonly used than     before, UIAs are increasingly being detected. Most patients with small aneurysms (less than     5mm) are incidentally found in clinical practice. Some studies indicate that the majority of     patients with UIAs, particularly with small aneurysms (<7mm), have a low risk of rupture, and     others have found that small ruptured aneurysms have a high proportion in patients with SAH.     Therefore, there is a lot of controversy regarding which small aneurysms can be left     untreated, or which aneurysms are needed to be treated with clipping or coiling.      The prevalence varies widely among different detection methods, race/ethnicity or patients     with other inherited diseases. Although a wealth of data is available for the natural history     of UIAs, the true natural history remains unknown because case selection bias occur in almost     all studies. However, data on Chinese UIA is unknown. Using the MR angiography (MRA) to     detect aneurysms, the prevalence is 7% of selected adult population in China. Therefore,     small UIAs are very common and are increasingly being detected in clinical practice.     Conservative treatment, surgical clipping and endovascular coiling are the three treatment     options for UIAs. The optimal treatment remains controversial, particularly for small     aneurysms (less than 7mm). To date, no clinical trials have compared the safety and efficacy     between conservative treatment and surgical clipping or endovascular coiling for UIAs. It may     be impossible to conduct the randomized controlled study considering aneurysm ruptured as a     devastating event. However, surgical clipping or endovascular treatment itself carries a risk     of immediate morbidity or mortality. Therefore, a substantial variability widely exists in     treatment decision-making for UIAs, and this may lead to a great variability in clinical     recommendations.      Our study is a prospective observational study to identify the incidence of rupture of small     aneurysms in the first year after the diagnosis of the aneurysm which is left untreated.     Meanwhile, we determine the differences of outcomes, procedural complications, and rates of     retreatment between surgical clipping and endovascular coiling for small UIAs in China.   "
25775|NCT02948491|"     Pragmatic, randomized controlled clinical trial with blinding of the evaluator, performed in     order to estimate the effectiveness, six (6) months after hospital discharge, of music     therapy on the intra-hospital evolution and neurodevelopment of preterm neonates (gestational     ages 28 to 37weeks) who are treated in Neonatal Intensive Care Units (NICU) in the     Bucaramanga Metropolitan Area.   "
25996|NCT02945423|"     Catatonia is a neuropsychiatric syndrome which is frequently missed or misdiagnosed among     psychiatric patients. The current project is a systematic examination of catatonia which will     characterize the phenotype and identify biological correlates that play a central role in the     pathophysiology and effective pharmacological treatment of this condition.   "
25796|NCT02948218|"     Knee osteoarthritis (KOA) is a major public health problem among the elderly and is     associated with considerable disability. A recent analysis of data indicated that about 35%     of women and men aged 60 years and above had radiographic knee OA.Despite the high prevalence     rate of OA, the treatment of OA is far from satisfactory. Acupuncture may be a promising     treatment option for knee OA due to the effectiveness of the pain relief and the rarity of     adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness     on KOA, a long-term follow up interventional study will be started to confirm the effects of     long term for acupuncture treatment.   "
27043|NCT02931760|"     Aim: To compare patient satisfaction with intramuscular placement of a pacemaker pocket to     subcutaneous placement.      Patients will be randomized (approximately half i each group) to receive the pacemaker device     either subcutaneously (current practise) or intramuscular)   "
25776|NCT02948478|"     Precariousness is a multifactorial concept that can be broken down in the form of economic     insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an     impact on health that is difficult to assess precisely because it also impacts on other     factors that may themselves influence health. Therefore, the understanding of the impact of     precariousness on health involves studying individuals in their context.      Our study is designed to assess the impact of precariousness on the history of breast cancer,     on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis.     Indeed, the socio -economic and geographical inequalities affect the history of breast     cancer, treatment and its delay and post- treatment rehabilitation.      The main objective of this project is to compare the stage of disease at diagnosis (according     to the TNM classification) in deprived and non deprived patients. The secondary objectives     are to compare in the two groups - the socio-economic and geographical inequalities - the     direct and indirect costs related to the management, the out-of pocket costs and to describe,     based on individual inequalities identified, the pathway of care of the patient.      These objectives will be pursued in the framework of an observational cohort study,     prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each     precarious patient will be matched to a non- precarious patient in the same age group,     regardless of the center. The study will include any patient resident in Ile de France     seeking treatment for breast cancer, regardless of the stage.   "
25777|NCT02948465|"     Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for     a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and     thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular     in proximal occlusion. Experimental studies suggest that neutrophils could play an important     role in the thrombus development via the organization of a network (NET) within the thrombus.     Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of     recanalisation and thus improve the neurological prognostic after a cerebral infarct.      The aim of the research is to Study of the biochemical and histological composition of the     stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the     thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).   "
25778|NCT02948452|"     This study is designed to understand responsiveness to reward in adolescents with     restricting-type anorexia nervosa compared with non-clinical controls, and how it is affected     by potential-threat perception.   "
25779|NCT02948439|"     Maintenance of a healthy pregnancy depends on an appropriate adaptation and responsiveness of     blood vessels, to ensure appropriate blood flow to the fetus during everyday stressors.     Previous work by the investigators has demonstrated that during pregnancy, the part of the     nervous system responsible for cardiovascular function (the sympathetic nervous system) is     hyperactive. The investigators also know that in women who develop high blood pressure during     pregnancy that sympathetic nervous system activity is even higher. Yet, very little is known     about why this occurs and how this might be affected.      Pregnant women are encouraged to be active, yet, less than 15% of women perform sufficient     exercise to meet current guidelines. This is important because hyperactivity of the     sympathetic nervous system is observed in other inactive populations and has been linked to     adverse cardiovascular health outcomes including hypertension, atherosclerosis, heart attack,     and stroke. Indeed, in 2011, the American Heart Association stated that inactivity was a risk     factor as potent as cigarette smoking for the development of future cardiovascular disease in     women.      The investigators' work and others have demonstrated that exercise during pregnancy is     beneficial for both the mom and baby; however, the effect of prenatal exercise on     neurovascular function is not known. If exercise is effective in controlling the increase in     sympathetic activity that occurs during pregnancy, or its effects on the cardiovascular     system, this may help prevent the development of high blood pressure or other cardiovascular     problems during pregnancy.   "
25780|NCT02948426|"     Ovarian cancer is a leading cause of cancer death in women. Monocytes are white blood cells     that slow tumor growth. Interferons (IFNs) are molecules that help immune cells fight cancer.     Researchers want to stimulate monocytes with IFNs. They want to test if these stimulated     monocytes combined with the drugs Sylatron and Actimmune can shrink tumors and slow the     progression of cancer.      Objective:      To test how well IFN stimulated monocytes, with Sylatron and Actimmune, kill tumor cells.      Eligibility:      Women ages 18 and older with certain ovarian, fallopian tube, or peritoneal cancers      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Scan      Results or sample from previous biopsy      Participants may have a tumor sample taken.      Participants who do not have a port will have a catheter placed inside the abdominal cavity.     It will be used to give the treatment.      Participants will have visits for 4 days of each 28-day cycle. This includes overnight     observation.      Participants with ascites fluid in their abdominal cavity will have it sampled twice.      Each cycle, participants will have:      Blood tests      Leukapheresis. Some blood is removed and put through a machine that separates out the     monocytes. The rest of the blood is returned to the body.      Infusion of the monocytes and study drugs      Participants will have weekly phone calls in Cycle 1 and scans every 2 cycles.      Participants will continue treatment until they can no longer tolerate it or their cancer     gets worse.      Participants will have a visit about 1 month after stopping treatment, then monthly phone     calls....   "
25792|NCT02948270|"     The interpersonal problems of adolescents with ADHD may be the most debilitating aspect of     their psychopathologic behaviour. This being said, the investigators still do not have a     clear understanding of why it is the case that individuals with ADHD have such impaired     social and communicative competence. In particular, research has not identified whether the     communicative difficulties stems from deficits in taking the perspective of a communicative     partner, or in being able to make use of this information in a systematic way. This study     will compare adolescents with ADHD to adolescents not diagnosed with ADHD and their     performance on a number of social inference and communication tests. This study hypothesizes     that persons with ADHD will not perform as effectively as control participants on the social     inference and communication tests, and will evidence lower WM score. As well, this study     hypothesizes that a working memory/cognitive load task will impede performance on certain     social inference and communication tests to a greater extent in the ADHD population than in     the control group.   "
25781|NCT02948413|"     Background:      A cancer diagnosis is a threat to life and bodily integrity. This can cause people with     cancer to experience traumatic stress. Researchers want to better understand the types of     stress and emotional reactions people with cancer experience. They also want to know if the     stress people with cancer have had during their life affects their stress related to cancer.      Objective:      To see if lifetime traumas, along with psychosocial distress, can predict traumatic stress     symptoms in people with cancer.      Eligibility:      People ages 18 and older who have had or are currently getting care from the NIH Clinical     Center for one of these cancers:      Leukemia      Lymphoma      Mesothelioma      Prostate cancer      Design:      Participants will be screened with name, date of birth, and diagnosis.      Participants will allow access to their medical records.      Participants will complete, online or in person, a demographic sheet and 3 questionnaires:      The PTSD Checklist for DSM-5: This assesses traumatic stress symptoms and takes 5 10      minutes to complete.      The Life Events Checklist for DSM-5: This assesses potentially traumatic life events and      takes about 5 minutes to complete.      The Brief Symptoms Inventory 18: This assesses psychosocial distress and takes about 4      minutes to complete.   "
25782|NCT02948400|"     The investigators will conduct a non-inferiority clinical trial to evaluate whether children     trained in pedestrian safety amidst a Google Cardboard virtual environment achieve equivalent     levels of pedestrian safety to children trained in a full semi-immersive virtual pedestrian     environment   "
25783|NCT02948387|"     Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in     patients with Type II and II open fractures is safe and effective.   "
25784|NCT02948374|"     Critical care patients are at a high risk of developing delirium and impaired cognitive     function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate     the pathophysiology behind delirium in the ICU and subsequent development of cognitive     dysfunction in ICU survivors.      Biomarkers in cerebrospinal fluid (CSF) will be analysed in patients with and without     delirium in the ICU. Samples will also be taken 3 and 12 months after the ICU-stay. CSF will     also be obtained in healthy age- and sexmatched controls undergoing surgery.   "
25785|NCT02948361|"     Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have     breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s),     standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR     recommendations.      If available, subjects may provide copies of their breast imaging exams and related reports.      Demographics and medical history will be collected.   "
25786|NCT02948348|"     This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety,     efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody     drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and     subsequent surgical therapy in patients with locally advanced resectable rectal cancer.   "
25787|NCT02948335|"     Microorganisms that colonize hospital environments play an important role in the transmission     of hospital acquired infections (HAI) and multi-drug resistant organisms. Previous studies     examining microorganisms in the hospital environment have been limited by reliance on     targeted culture-based methods resulting in potentially missed or unrecognized organisms.     Evidence now suggests that using microbiome analysis offers an innovative strategy that may     improve our understanding of HAI and how best to prevent them.      This pilot longitudinal observational study aims to characterize the taxonomic composition of     microbial communities on environmental surfaces and people in these environments prior to and     following the introduction of patients, caregiver, and hospital staff to newly constructed     inpatient care areas at St. Jude Children's Research Hospital (SJCRH). This proposed study is     uniquely characterized by evaluating the hospital environment of a pediatric     immunocompromised oncology patient population that has not been studied in the past using     advanced molecular techniques such as microbiome analysis.      PRIMARY OBJECTIVE:        -  To describe the pattern of microbial communities of the hospital environment before,          during and after patient occupancy of a newly constructed hospital space.      SECONDARY OBJECTIVES:        -  To describe the similarity or difference of environment microbial communities to that of          the humans occupying this environment in a newly occupied hospital space.        -  To describe the pattern in environment microbial communities after each step of          disinfection (manual cleaning with chemical disinfectant and Ultraviolet light          disinfection machine) after patient discharge from the inpatient hospital environment.        -  To evaluate the correlation between environmental Adenosine Triphosphate (ATP) measures          and organism bioburden.   "
25788|NCT02948322|"     In this study, the investigators will evaluate the cardiac structure and function, focusing     on the myocardial water content and interstitial fibrosis, in patients with active acromegaly     in comparison with 1) healthy volunteers, 2) the same acromegalic patients that have received     efficient therapy.      The investigators hypothesize that the myocardial water content in acromegaly is increased as     these patients present with sodium and water retention and that this myocardial water     infiltration will improve with efficient treatment of the disease. They will thus assess     using CMRI, this parameter by measuring the myocardial transverse relaxation time (T2),     reflecting water content in the myocardium.   "
25789|NCT02948309|"     In this study a mistletoe preparation (Iscador Qu) is added to standard therapy in inoperable     pancreatic cancer in order to evaluate effect on overall survival and health-related quality     of life. Half of participants will take subcutaneous injections with mistletoe in addition to     standard therapy (palliative chemotherapy or best supportive care); the other half will     receive a placebo and standard therapy.   "
25790|NCT02948296|"     The goal of this study is to evaluate the efficacy of two promising brain stimulation     treatment protocols designed to decrease the brain response to alcohol cues among heavy     alcohol users.   "
25791|NCT02948283|"     This pilot clinical trial studies the side effects and best dose of metformin hydrochloride     and ritonavir in treating patients with multiple myeloma or chronic lymphocytic leukemia that     has returned after a period of improvement or has not responded to treatment. Metformin     hydrochloride and ritonavir may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth.   "
25997|NCT02945410|"     The purpose of this study is to determine if an increased protein intake can attenuate the     suppression of metabolic and anabolic hormones during caloric restriction   "
25998|NCT02945397|"     The study compares the effect of a group-based activity with an individual work-out activity     on work participation.   "
25795|NCT02948231|"     The Mistral is an investigational device intended for percutaneous trans-catheter repair in     high risk for surgery individuals suffering from functional Mitral Regurgitation.      The device system is to be used only in accordance with the approved Investigational Plan on     subjects who have signed an informed consent form. Device use is limited to the approved     study investigators.   "
25797|NCT02948205|"     This study intends to carry out a prospective, randomized controlled trial to compare the     trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal     laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify     the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis     for its application in infertility population.   "
25798|NCT02948192|"     Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks     of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at     enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be     obtained at entry and at the time of delivery for metabolomic analysis. Participants will     also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological     specimens will then be analyzed for their microbiomial profile. This will then be correlated     with the timing of their delivery as well as other comorbidities such as obesity,     hypertension, and diabetes.   "
25799|NCT02948179|"     Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic hereditary     kidney disease in humans. ADPKD may affect all the generations of the ADPKD family and the     probability of ADPKD is 50% in the second generation for each gender. It has been confirmed     that PKD1 and PKD2 are two pathogenic genes of ADPKD. Nowadays, the investigators have     established an effective gene detection technology platform for PKD1/2 gene with long     fragment PCR and next generation sequencing. First, the investigators performed genetic     testing in patients with clinically diagnosed ADPKD and strong fertility desire, but afraid     of hereditary risk. Using Preimplantation genetic diagnosis, including multiple annealing and     looping-based amplification cycles amplification technique, the investigators successfully     screened out healthy embryos by In Vitro Fertilization. Then the investigators transplanted     embryos returned to the parent. When the baby is born, using umbilical cord blood gene     detection, the investigators confirmed that the neonates do not inherit genetic defects form     parents. The investigators have succeeded in one couple. The investigators design a     multicenter clinical trial to confirm those procedures efficacy and safety.   "
25800|NCT02948166|"     Comparison of two methods for revascularization of the superficial femoral artery: remote     endarterectomy vs. stenting of the superficial femoral artery cin patients with     steno-occlusive lesion of the femoro-popliteal segment of TASC C, D   "
25801|NCT02948153|"     This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial     hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2)     mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of     TLRs differ from non-mucus hypersecretory asthmatics patients.   "
25802|NCT02948140|"     The aim of the study is to estimate the contribution of abdominal imaging by magnetic     resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic infarction     associated to the atrial fibrillation in the cerebral infarction.   "
25803|NCT02948127|"     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in     RSV-seronegative infants and children 6 to 24 months of age.      This study is a companion study to IMPAACT 2012.   "
25804|NCT02948114|"     The study is intended to evaluate the microorganisms found in infant stools when consuming     study formulas containing prebiotics and/or probiotics compared to infants consuming mother's     own breast milk.   "
25805|NCT02948101|"     The goal of this clinical research study is to learn about the effects of PD 0360324 on     participant's immune system in participant's with epithelial ovarian, Fallopian tube, or     primary peritoneal cancer and who have agreed to participate on Protocol PA13-0291. As part     of this study, participant will also receive a type of standard chemotherapy called     cyclophosphamide.      The safety of PD 0360324 and cyclophosphamide will also be studied.   "
25806|NCT02948088|"     TGCT is a rare disease that is difficult to manage, surgical resection is the primary     treatment currently available. To date no disease registry exists and there is little data     available detailing the management of patients with diffuse TGCT, the burden of diffuse TGCT     for patients (including pain, joint stiffness, swelling, reduced mobility and quality of     life) or the economic impact of diffuse TGCT.      This study aims to collect data by an observational disease registry involving no     intervention to the patient or changes to investigators treatment decisions.   "
25843|NCT02947412|"     Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it     is gaining popularity as a single procedure. Long term data is scarce. In this retrospective     study long term follow-up in relation to weight loss, comorbidities, re-do and revisional     surgery is getting analyzed.   "
25807|NCT02948075|"     This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination     with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced     epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to     first line platinum and Paclitaxel based chemotherapy.      The study will be carried out in 5-8 Russian and Belarusian sites. A maximum of 32 patients     with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or     fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy,     will be enrolled in the study.   "
25808|NCT02948062|"     The goal of this single institution study is to evaluate boys with adrenoleukodystrophy (ALD)     diagnosed early in life, and to prospectively monitor them to determine parameters that will     facilitate earlier detection of the childhood cerebral form of the disease. These at-risk     subjects will be assessed yearly through travel to the University of Minnesota, where plasma     and cerebral spinal fluid (CSF) biomarker studies, MRI based imaging and neuropsychological     assessments will be performed at the University of Minnesota Masonic Children's Hospital and     Clinics. The MRI and lumbar puncture to obtain CSF will be obtained under sedation. In     addition, at intervening 6 months intervals information will be obtained remotely, including     surveys and MRI's in their home location. Also at that time blood samples will be obtained     locally and shipped to the University of Minnesota for study. There is no therapeutic intent     in this study.   "
25809|NCT02948049|"     This study is a single site, prospective, observational trial utilizing a wrist-worn     accelerometer to evaluate clinical outcomes of SCS and PNS in the treatment of chronic pain.   "
27044|NCT02931747|"     The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and     cognitive processing in student.   "
25811|NCT02948023|"     This is a investigative initiated, comparative pilot clinical trial to ascertain the safety     of application of ex-vivo cultivated limbal stem cells in human eyes for treating different     superficial corneal pathologies. Pre-clinical work in murine models have already demonstrated     efficacy of this technique in curing murine corneal pathologies.   "
25812|NCT02948010|"     The purpose of this trial is to assess device performance against participants in an     overnight study to ensure the product meets user and clinical requirements   "
25813|NCT02947997|"     The purpose of this study is to test the safety and feasibility of a redesigned tethered     capsule catheter that contains an integrated micro-motor. Investigators will be testing     imaging of this new technology in healthy volunteers.   "
25814|NCT02947984|"     The purpose of this study is to determine the best radiation dose for participants with     meningioma that has grown back after previous surgery, or which the surgeon has been unable     to remove completely. This research study is designed to determine whether a higher dose of     radiation will decrease the likelihood that the tumor will grow back, compared to the     probability of re-growth that occurs after standard radiation doses.   "
25815|NCT02947971|"     The goal of this research is to test a distal scanning capsule and a compact redesigned     version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety     and feasibility in preparation for its use in a multicenter clinical trial.   "
25816|NCT02947958|"     To evaluate the effectiveness of the use of teleconsultation in qualifying counter-reference     between tertiary and primary care for patients with stable benign prostatic hyperplasia (BPH)     symptoms.   "
25817|NCT02947945|"     Reslizumab is a type of medicine called a monoclonal antibody that is made in the research     clinic; it works by blocking a specific protein in the body called interleukin-5. The study     medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is     considered an experimental drug in this study.   "
25818|NCT02947932|"     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in     high risk patients was considered a standard method to prevent PEP. However, the risk     factors of PEP is not fully clear. Additionally, the complication of NSAID use lead to some     serious physical problem bleeding. Therefore, the exclusive criteria for limiting the NSAID     use is including allergy， gastrointestinal haemorrhage ，presence of coagulopathy or received     anticoagulation therapy. Previous study showed that another natural compound, resveratrol,     owns similar biological effect with NSAID. Firstly, it could inhibit the inflammatory     response on in vivo model through inhibition of COX and IL-6 etc. Secondly, it could not     influence the level of platelet and coagulation, which means safer than NSAID. Thirdly,     numerous studies showed that resveratrol could effectively the progression of severe acute     pancreatitis. According to data, we design the project. The purpose of this study is to     determine whether oral resveratrol pre-ERCP is effective on control of Post-ERCP     pancreatitis.   "
25819|NCT02947919|"     Preoperative anxiety and stress are present in up to 60% of pediatric patients undergoing     surgery, having a great physiological and emotional impact on children in both the short and     long term. There are many reports on the use of music therapy in the perioperative period as     a complementary technique in the preoperative stress and anxiety management. However, there     are no assessments of the effect of this intervention on the physiological variables, such as     salivary cortisol.   "
25820|NCT02947906|"     Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be     participants of the study.Participants with multiple sclerosis will evaluate with the     following assessment tools: Modified Ashworth scale will use to evaluation of severity of     plantar flexor spasticity. Plantar pressure distribution parameters will assess with dynamic     pedobarography.   "
25821|NCT02947893|"     The investigators hypothesize that Nilotinib will be safe in individuals with mild to     moderate AD. Specifically, investigators hypothesize that low daily oral doses of Nilotinib     will lead to CSF penetration, CNS Abl inhibition, and stabilization of CSF total Tau and     p-Tau231/181 and Abeta42/40 levels. The investigators hypothesize that Nilotinib will     decrease brain load of amyloid using amyloid positron emission tomography (PET). The     investigators also predict that Nilotinib will reduce CSF markers of cell death, including     neuron specific enolase (NSE) and S100B.   "
49392|NCT02639130|"     To determine the extent to which the effects of treatment with LAF237 100 mg QD on glucagon     secretion are mediated by Glucagon-like-peptide 1 (GLP-1) in type 2 diabetic patients and     healthy subjects.   "
25822|NCT02947880|"     During a previous therapeutic trial, investigators showed that the bumetanide improved     significantly autism. This trial showed that a therapeutic response was obtained in 75% of     cases.      These first results were reinforced by a study led with adult patients for whom the eye     tracking measurements as well as the functional MRI showed a diminution of the response time     and a modification (amplification) of the cerebral response during an emotions recognition     test.      Finally, investigators confirmed the physiological mechanism behind the action of the     bumetanide in a study in two mouse models of autism.   "
25823|NCT02947867|"     A prospective, randomised, placebo-controlled, double-masked, three-armed multi-centre phase     II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion     to Prevent Neovascular Glaucoma - the STRONG Study   "
25824|NCT02947854|"     Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in     novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance     the effects of other drugs in a site-specific, light-directed manner and is used to     re-localise endocytosed molecules from endosomes to cytosol. This research study is     evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens     for safety and induction of immune responses.   "
25902|NCT02946645|"     Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern     dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD     patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of     TMD. To our knowledge, no specific trials have been designed for the evaluation of the     efficiency of physiotherapy vs neuromuscular bites in TMD patients.      The aim of this trial is to evaluate the efficiency in term of cranial muscles     electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs     manual physiotherapy therapy compared to placebo.   "
25825|NCT02947841|"     The purpose of this study is to investigate the hypothesis that alternating DBS parameters on     a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared     with non-alternating stimulation. The primary endpoint will be preserved tremor control with     the alternating group compared with standard treatment using the Tremor Research Group     Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved     activities of daily living measures as well as preserved tremor control as quantified by     motion sensor data.      This study has one primary aim: To determine if alternating DBS stimulation parameters on a     weekly basis will be superior at preserving tremor control compared with usual stimulation     (non-alternating stimulation) in ET patients with VIM DBS.   "
25826|NCT02947828|"     This is a population-based study of type 2 diabetes patients with and without neuropathy     recruited from the Danish National Type 2 Diabetes cohort (DD2).      Perspective: The study will identify risk factors for developing diabetic polyneuropathy and     painful diabetic polyneuropathy and provide information on the underlying mechanisms, which     will hopefully contribute to significant improvements in the treatment and prevention of     diabetic polyneuropathy in future.   "
25827|NCT02947815|"     The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of     essential blepharospasm   "
25828|NCT02947802|"     This is an online survey assessing consumer support for different labeling policies related     to sugar sweetened beverages. The investigators will present consumers with three labels that     are being considered for sugar sweetened beverages: a calorie label, a text warning label     that says Warning drinking beverages with added sugar(s) can lead to health problems like     obesity, diabetes and tooth decay and a graphic warning label that includes graphic images     to correspond with each of the health problems listed with the text warning. The     investigators will ask participants their support for each label. The investigators will also     see if support for the labels change after learning of the effectiveness of these labels. The     investigators will share the results of a recent field study that suggested calorie and     textual warning labels had no influence on the purchasing of sugar sweetened beverages while     the graphic label decreased purchasing by 11 percent.   "
25829|NCT02947789|"     Surgery has risk of morbidity and mortality. Risk factors include: patient factors; surgical     factors; and anesthetic factors. The risk is much higher in emergency cases. The study of     relevant risk factors can lead to improvement in patient management and reduction in     mortality.   "
25830|NCT02947776|"     Aims: This exploratory trial will:        1. Explore the feasibility of a definitive/phase III RCT on clinical and cost-effectiveness          of peer-befriending for people with aphasia post-stroke.        2. Investigate psychological and social wellbeing outcomes of participants, significant          others, and peer befrienders.        3. Explore the feasibility of a full economic evaluation of usual care + peer befriending          versus usual care control.      Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care +     peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver     on four work packages: development phase; RCT; qualitative study; economic evaluation.     Participants (n=60) will be assessed three times up to 10 months post-randomisation.      Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion     screened who meet criteria; proportion who consent; rate of consent); participant,     significant other, peer befriender views on acceptability of procedures (qualitative study);     number of missing/incomplete data on outcome measures; attrition rate at follow-up; potential     value of conducting main trial using value of information analysis (economic evaluation);     description of usual care; treatment fidelity of peer-befriending. Patient-reported outcomes     will include mood, wellbeing, communication and social participation.      Benefits: Peer befriending may help avert some of the serious psychological consequences of     stroke, and prevent the need for more complex and costly psychological therapies.   "
25831|NCT02947763|"     Healing rate after single visit or multiple visit endodontic treatment using triple paste     intracanal medicament will be assessed both clinically and radio-graphically for follow-up     period up to one year   "
25832|NCT02947750|"     The purpose of this study is to find out why patients with chronic kidney disease (CKD) have     poor exercise capacity and to explore what causes an increase in blood pressure during     exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).     This study will also test whether or not regular exercise on a bicycle and/or treatment with     6R-BH4 (Kuvan) pills improves these measures during exercise. 6R-BH4 is currently     FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but     it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.   "
25873|NCT02947022|"     Purpose: There are two goals we have for this prospective single arm study; to see an     increase in the amount of gadolinium in 24 hour urine collection following each infusion     treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium     deposition disease (GDD) symptoms.      Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)      Procedures: Over a series of three (3) treatment time-points patients will be treated with IV     Ca-DTPA on day one, and Zn-DTPA on day two.   "
25833|NCT02947737|"     The purpose of this study is to compare the effectiveness of applying amniotic membrane     dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. This     study will enroll ten participants who undergoing a split thickness skin graft procedure with     two or more donor sites. The amniotic membrane will be applied to one donor site and a     dressing of xeroform and gentamicin will be applied to another other donor site. Each     participant will receive both types of dressing and will serve as their own control.     Postoperative follow up will follow standard of care, regardless of the dressing type.     Dressings will be removed on postoperative day 4 and participants will return to be     re-examined one week after being discharged from the hospital.   "
25903|NCT02946632|"     In this study, the investigators will assess the efficacy and tolerability of a novel,     initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared     to conventional stepwise add-on therapy in drug-naïve patients with recently onset type 2     diabetes.   "
25904|NCT02946619|"     This study is a randomized controlled trial (RCT) with the aim of determining the cultural     sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese     breast cancer survivors.   "
25834|NCT02947529|"     BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative     blood loss for various orthopaedic procedures including but not limited to total hip     arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in     2013 showed that patients who received TXA showed a significant reduction in post-operative     transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the     intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures     are similar to the total hip or knee replacement in that they can result in significant blood     loss that requires a post operative transfusion.      STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative     transfusion for acute hip fractures repaired with the following two methods, intramedullary     nailing for intertrochanteric fracture and hemiarthroplasty.      METHODS: The model for the study is a prospective randomized control trial. Patients will be     placed in one of two arms of the study after passing our inclusion criteria. The arms will be     for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty.     These two categories will be subdivided into those receiving TXA and those not receiving TXA.     The patients in each category will have standard post-operative care and laboratory testing.     The investigators will record the patients in either arm of the study, whether it be no TXA     or TXA, who require post-operative transfusion within 1 week of the operation.   "
25835|NCT02947516|"     There are several ways to perform liver biopsies, including the percutaneous route     (historical gold standard) and via endoscopic ultrasound (EUS) guidance. The primary aim of     this study is to prospectively compare patients undergoing EUS-guided liver biopsies to     patients undergoing percutaneous biopsy. The investigators hypothesize that (1) patients who     are randomized to undergo EUS-guided liver biopsy will rate themselves as having less pain in     the 48 hours following the procedure, and (2) will have comparable histologic yield to a 2:1     matched cohort of patients undergoing percutaneous liver biopsies.   "
25836|NCT02947503|"     One approach to prevent the rising burden of diabetes is to address the issue of gestational     diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in     specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM     increases the risks of complications during pregnancy, at delivery and on the longer term,     like type 2 diabetes (T2D) and persistent obesity, in mother and child. Moreover, insulin     added to diet as the standard care for GDM has disadvantages for mother (maintenance of     hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia,     hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer     targeting the cause of GDM, may have essential benefits, as suggested by observational     studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still     lacking. The POEM study is the first Randomized controlled trial (RCT) in GDM to test the     hypothesis that metformin, early given from the start of the diagnosis GDM, on top of diet     and lifestyle improves clinically relevant pregnancy outcomes in mother and child during     pregnancy, at delivery and on the longer term - up to 20 years after birth.   "
25837|NCT02947490|"     This blinded end point RCT will recruit high risk TIA and mild stroke patients (through the     emergency TIA clinics and the acute stroke services at the Norfolk & Norwich University     Hospital) who require anti-hypertensive therapy to examine the clinical and cost     effectiveness of self-monitoring and self management of Blood Pressure compared to self     monitoring alone and treatment as usual.   "
25838|NCT02947477|"     The proposed study will develop and pilot a fourteen-day assessment tailored for the     high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses     ecological measurement assessment (EMA), which solicits real-time user feedback at various     time points across a series of days or weeks.   "
25839|NCT02947464|"     Cure rate os pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment     adenotonsillectomy is 50-80 %. Treatment alternatives are scarce, poorly effective and based     up on low scientific evidence. This means one out of five patients will remain exposed to the     well-known neurocognitive, behavioral and quality of live adverse effects of disease.      Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion,     has recently shown promising results in the treatment of pediatric OSAS based upon its effect     on craniofacial and upper airway growth, usually limited in this patients.      The investigators propose a randomized, prospective, controlled trial in patients with     Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the     treatment success rate avoiding morbimortality associated to disease persistence during     childhood and development during adult life.   "
25840|NCT02947451|"     Patients with knee Osteoarthritis have high prevalence of pain , requiring ever more precise     interventions in their management. This study aims to investigate the immediate effects of     manual therapy and TENS on pain in patients with knee Osteoarthritis. Knowledge of best     interventions favors reducing spending on health and safety for the patient.   "
25841|NCT02947438|"     This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO®     and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The     targeted population is anaemia patients with end-stage chronic renal disease who previously     received epoetin treatment and on haemodialysis.   "
25842|NCT02947425|"     This is a prospectively registered database of patients with early breast cancer who will be     treated with radiotherapy during surgery. More than 2000 women have already received this     treatment in clinical trials. This study will monitor the health status of women who receive     this treatment outside of a clinical trial, especially those who might not have been eligible     for the original clinical trials. The aim is to confirm the long-term effectiveness and     safety of the technique.   "
25905|NCT02946606|"     This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study     designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics     of weekly and every other week doses of GX-H9 in the treatment of AGHD.   "
25921|NCT02946398|"     Procedures for identification of high-risk elderly patients in the emergency department are     lacking.      We aim to identify the risk factors associated with an adverse outcome in elderly patients     who visit the emergency department (ED). Second, we aim to find practical tools to identify     those elderly patients who are at risk for an adverse outcome in an early stage (by applying     and testing triage and risk stratification scores, clinical impression and laboratory     results).   "
25844|NCT02947399|"     This research study is to compare the radiopharmacokinetics of I-124 to the     radiopharmacokinetics of I-131 in patients who have well-differentiated thyroid cancer after     thyroid hormone withdrawal. I-131 is routinely used for imaging and dosimetry for patients     with well-differentiated thyroid cancer. In this study, I-124 is administered orally in     capsular form, and the radiopharmacokinetics of I-124 is compared with I-131. I-124 is     another isotope of iodine, which is cyclotron-produced. I-124 has multiple advantages:        -  Ideal Half-Life (4.2 days) for delayed imaging.        -  High resolution tomographic imaging.        -  Feasibility of quantitating lesion uptake.        -  Potential of dosimetry for the planning of radioiodine therapy.      Voluntary patients will have I-124 dosimetry performed in addition to the I-131 dosimetry,     which is planned as part of routine clinical care. I-124 dosimetry is composed of three     parts: (1) the administration of I-124, (2) imaging, and (3) drawing blood samples.      Patients will start 3-5 weeks of thyroid hormone withdrawal. This is similar to the procedure     for I-131 dosimetry. Second, they will receive I-124. I-124 is similar to I-131 except I-124     decays in a different way to emit a positron so that the PET scanner can be used for imaging.     I-124 is given in the form of one or several capsules, which are taken by mouth. This is also     similar to I-131. Third, PET/CT imaging is done for approximately 30 minutes to one hour on     five consecutive days. Radiation from PET/CT scan is far less than what they receive from a     diagnostic CT scan. For the fourth part, a technologist will draw about 5 cc from the forearm     on each of the five consecutive days. This is also similar to I-131.      Initially, all patients will be randomized to one of two study groups. The first group will     have the I-131 dosimetry performed first followed by the I-124 dosimetry, and the second     group will have the I-124 dosimetry performed first followed by the I-131 dosimetry.      The risk of this study is considered very low, and the potential benefits to the patient are     considered very high.   "
25845|NCT02947386|"     This phase I/II trial studies the best dose and side effects of nimotuzumab when giving     together with nivolumab and to see how well they work in treating patients with non-small     cell lung cancer that has spread to other places in the body and usually cannot be cured or     controlled with treatment. Monoclonal antibodies, such as nimotuzumab and nivolumab, may     block tumor growth in different ways by targeting certain cells.   "
25846|NCT02947373|"     This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium     (PNOC).      The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13     imaging in children with brain tumors.   "
25847|NCT02947360|"     Broad Goal: To demonstrate that focused vascular ultrasound (FOVUS) can accurately risk     stratify patients with chest pain in the emergency department (ED).      Background and Rationale: Traditional risk assessment focuses on characteristics of the pain,     known Coronary Artery Disease (CAD), risk factors, electrocardiogram (ECG), and blood tests     to identify active ischemia. Identifying clinically significant CAD remains one of the most     challenging tasks in the ED. Current clinical decision rules err on the side of over     investigation and admission. To address this limitation, the Investigators have developed a     point-of-care carotid ultrasound test predictive of CAD. The Investigators have shown that     carotid plaque is strongly associated with significant angiographic CAD in a population     referred for angiogram.      Research Aims:      Primary - To determine the association between carotid plaque measured by a dedicated     sonographer and 30-day major adverse cardiac events (MACE), including MI, reperfusion, or     death in patients presenting to the ED with suspected cardiac ischemia.      Secondary - To determine the agreement sonographer and emergency physician FOVUS results.      Methodology: The Investigators propose a prospective cohort study to assess the prognostic     value of a novel point-of-care carotid ultrasound plaque quantification protocol in the ED of     Kingston General Hospital. We will enroll 500 consecutive patients presenting with a chief     complaint of chest pain prompting at least one 12-lead ECG and troponin measurement. Patients     will undergo carotid scan by a dedicated sonographer and emergency physician. Patients will     be followed for MACE for 30 days. Those performing scans will be blinded to clinician's     impression and care plans while clinicians will be blinded to FOVUS findings. The primary     analysis will involve determination of the sensitivity, sensitivity, positive predictive     value, negative predictive value and likelihood ratios associated with FOVUS for 30-day MACE.      Expected Outcomes: The study will provide evidence to determine whether FOVUS may be a useful     prognostic tool for emergency physicians assessing patients with suspected ischemic chest     pain. The secondary analysis will provide evidence to determine whether emergency physicians     can be trained to measure carotid plaque height accurately when compared to the gold standard     ultrasonographer measurement.      Significance: If FOVUS can reliably identify very low risk patients, implementation of this     novel tool could reduce ED length of stay, monitoring, and overcrowding.   "
25848|NCT02947347|"     The purpose of this study is to evaluate whether the addition of ibrutinib will result in     prolongation of progression-free survival (PFS) when compared with rituximab alone in     treatment naïve subjects with follicular lymphoma.   "
25849|NCT02947334|"     This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel     group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab     150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or     mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of     approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of     which approximately 600 subjects will be from sites in China. Subjects will be randomized     into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.   "
25850|NCT02947321|"     Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and     functional status in non-surgical patients with knee osteoarthritis as well as the high     prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed     to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic     postoperative pain as well as functional status in patients undergoing TKA. Patients will be     randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group     (RFA needles placed in proper location without effective neurotomy).   "
25851|NCT02947308|"     This study will examine longitudinal brain development in young adolescent girls with a     history of Non-Suicidal Self-Injury (NSSI). Specifically, three constructs outlined by the     the Research Domains Criteria (RDoC) will be examined through self-assessment, MRI, and a     cognitive battery.   "
25852|NCT02947295|"     To develop a rapid, sensitive, and inexpensive diagnostic method, as well as more efficacious     vaccine, for countries where typhoid fever remains a major public health burden.   "
25853|NCT02947282|"     The pelvic floor is composed of muscles and connective tissue which acts to provide support     for pelvic organs, and weakness or injury to the pelvic floor can result in pelvic floor     dysfunction. Respect for patient autonomy is a guiding principle in medicine and is of     increasing importance for patients. The PREPARED Trial hopes to demonstrate whether a single     workshop on pelvic floor health during pregnancy will lead to improved knowledge of pelvic     floor symptoms postpartum, increase the practice of pelvic floor muscle exercises, increase     satisfaction with their delivery experience, and change participants preferences and thoughts     surrounding various modes of delivery.   "
25889|NCT02946814|"     This study aims to evaluate the in situ antibacterial activity of a mouthwash containing     essential oils with and without alcohol on undisturbed de novo plaque-like biofilm     (PL-biofilm) up to 7 h after its application.      An appliance was designed to hold six glass disks on the buccal sides of the lower teeth,     allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then     performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5,     and 7 h later. After a washout period, the same procedure will be repeated with a sterile     water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital     staining, samples will be analyzed using a confocal laser scanning microscope analysing their     bacterial viability and thickness.   "
25854|NCT02947269|"     Postoperative ileus (POI) refers to the period of gut dysmotility that occurs after abdominal     surgery. Patients with POI are unable to eat, suffer ongoing nausea and vomiting, are unable     to open their bowels and have a prolonged hospital stay. Research at ADHB shows that 25% of     patients will have a prolonged POI after elective bowel resection, which makes it the most     common major complication after colorectal surgery. Clinicians currently lack a definitive     medication to prevent or treat POI, which means POI causes patients ongoing morbidity and     places a significant drain on healthcare resources. Serotonin plays an important role in gut     motility. Evidence suggests that serotonin agonists, such as prucalopride, increase gut     transit and may have anti-inflammatory properties. The hypothesis of this study is that     Prucalopride given pre-operatively and continued post-operatively in patients having an     elective bowel resection will improve gut function recovery after surgery and reduce POI.      The investigators' proposed study is a double-blinded randomised controlled trial of     prucalopride compared to an identical placebo tablet, in patients having an elective bowel     resection at Auckland City Hospital. Patients will receive a single tablet of Prucalopride or     placebo 2-3 hours preoperatively and then daily after operation for a maximum of 6 days. The     primary endpoint will be return to bowel function defined by the time to tolerate a solid     diet and pass stool. In addition, the investigators plan to assess postoperative gastric     emptying rates using the safe and non-invasive carbon breath test method. This will allow the     investigators to determine the effects of prucalopride on the stomach, and support its role     as a gastric prokinetic.   "
25855|NCT02947256|"     Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared     to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred     chole-cystohepatic (Calot's) triangle.   "
25856|NCT02947243|"     Children with burn injuries experience severe pain intensity during medical procedures     despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain     management recommend the combination of non-pharmacological and pharmacological interventions     to enhance pain management and decrease the numerous side effects of analgesics. Virtual     reality (VR) has gained growing consideration as a non-pharmacological method as it engages     multiple senses and allows interactions with a virtual world. Oculus Rift ® is a new     technology in VR that provides more immersiveness, at a relatively low cost, and could     probably improve the management of pain and anxiety in burn care. It also has the potential,     with appropriate custom software designed for burn pediatric patients, to reduce the     cybersickness symptoms (nausea, dizziness) associated with VR. To the knowledge of the     investigators, none of the pediatric hospitals across Canada have tested VR as a method of     pain and anxiety management in children with burn injuries. Overall hypotheses: VR     distraction via Oculus Rift ® could be an effective method to relieve pain, and anxiety, as     well as a less traumatizing hospital experience, while promoting a more humanistic care     environment by combining new technologies (VR via Oculus Rift ®) to standard analgesic     interventions administered to these children. The expected results will have a direct effect     on physical (pain) and psychological (anxiety, pain memories) health of the child. In     addition, clinical implications may include other indicators of quality of care and economic     benefits such as a wider range of motion of burned limbs and reduction in dosage of opioids     and anxiolytic drugs administered.   "
25857|NCT02947230|"     The McMaster Optimal Aging Portal (the Portal) was launched in 2014 to increase public access     to trustworthy health information. The Portal helps readers to access evidence-based     resources; identify trustworthy messages; and understand scientific findings. Now the     investigators want to know whether using the Portal changes what people know and do to stay     healthy and mobile.      This project will help us to:        1. Understand how middle aged and older adults (age 40+) use the Portal to obtain          information about maintaining and improving mobility        2. Evaluate whether use of the Portal results in a change in knowledge about maintaining          and improving mobility, or change in lifestyle behaviours that may help maintain or          improve mobility with age.   "
25858|NCT02947217|"     In this study the investigators propose a randomized controlled trial to evaluate the effect     of influenza vaccination on clinical pregnancy rates among women undergoing in vitro     fertilization.   "
25859|NCT02947204|"     The investigators will conduct a study around the best way to monitor infants hospitalized     with bronchiolitis, the most common lung infection and a leading reason for hospitalization     in infants. Infants with bronchiolitis have breathing difficulties and are provided     supplemental oxygen if their oxygen levels are low. However, there is uncertainty regarding     how to best monitor oxygen levels. A probe placed on the hand or foot can be used to monitor     oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours     (intermittent oxygen monitoring). Research has suggested that placing infants with     bronchiolitis on continuous monitoring results in unnecessary use of oxygen and infants     staying longer in hospital. However, due to the lack of high quality research, its unclear     which strategy is best and practice varies. The objective of this study is to conduct high     quality research across hospitals to determine whether intermittent compared to continuous     oxygen monitoring will reduce the length of hospital stay in infants hospitalized with     bronchiolitis. The investigators will also compare safety and cost. The results of this study     will inform bronchiolitis practice standards and the best use of health care resources.   "
25860|NCT02947191|"     The purpose of this study is to assess the safety and efficacy of collagen membrane combined     with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in     patients with chronic nasal septum perforation.   "
25888|NCT02946827|"     FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are     characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are     utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting     FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability     to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The     principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel     syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to     intestinal distension.      The focus of the study is to evaluate if in celiac patients with persistent abdominal     symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms.     Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk     of nutritional inadequacy.   "
25861|NCT02947178|"     Femoroacetabular impingement is a pathologic process within the hip joint that results from a     mechanical discord between the femoral head and neck and the acetabulum that results in     chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2     Historically an open surgical hip dislocation was performed to treat patients with this     condition, however with recent advances in arthroscopy, patients more commonly now undergo     arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide     peri-operative analgesia included intraarticular or portal analgesic injections. More     recently, regional anesthesia techniques are being employed to provide more reliable and     longer lasting post-operative pain control.3, 4 Currently, there are several local     anesthetics available for regional anesthesia. However, they only provide an average of 12-18     hours of post-operative pain control following a single injection.5 Bupivacaine is a local     anesthetic that has been used for many years by multiple routes to control post-operative     pain. A new formulation of the medication prolongs the release of the active ingredient after     a single injection and has been shown to result in up to 72 hours of post-operative     analgesia.6, 7 To the investigator's knowledge, there has not been any studies in the     literature comparing a historical control local anesthetic to this new formulation of     liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration blockade to     provide post operative pain control following hip arthroscopy.   "
25862|NCT02947165|"     To characterize the safety and tolerability of NIS793 as single agent and in combination with     PDR001 and to identify recommended doses for future studies.   "
25864|NCT02947139|"     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155     / DWC20156 and DWC20161 in Healthy Volunteers   "
25865|NCT02947126|"     When developing new medications for lung diseases like Cystic Fibrosis (CF), scientists     perform lab experiments using cells from the airways, physiology studies of how the lungs     change when a drug is given, and clinical studies to determine how drugs affect overall     health. The investigators of this study are seeking to develop computer models that will     predict how patients will respond to drugs by just doing lab studies on cell samples from     their noses. Such models would allow for medications to be developed more rapidly for all     patients and allow treatments to be personalized as well. In order to develop these computer     models a series of tests will be performed on patients who have CF. Tests will include     sampling cells from the nose and measuring lung physiology using a combination of different     imaging, breathing, and other studies performed both before and after participants take a     therapy. Similar tests will be performed on people who do not have CF, and on the parents of     the CF participants who carry a single CF gene because this will provide information on how     specific genes might affect CF lung disease.   "
25866|NCT02947113|"     Concurrent chemoradiotherapy is the standard treatment for locally advanced non-small cell     lung carcinoma (NSCLC). Different chemotherapy and radiation regimens have been advocated but     in general, cisplatin-doublets are deemed standard of care. Decreasing the overall treatment     time of irradiation by hypofractionation is thought to increase the efficacy. Extensive     experience is available on the combination of daily-dose cisplatin in combination with     hypofractionated radiotherapy. However, no data is available on the safety of cisplatin     doublets and hypofractionated radiotherapy   "
25867|NCT02947100|"     The purpose of this study is to determine the safety of a new formulation of the omega-3     fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) and to assess whether     it decreases inflammation and inflammatory pain in children and young adults with Sickle Cell     Disease.   "
25868|NCT02947087|"     Primary objective: To describe and compare the safety and efficacy of treatment with AAT in     chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation     (TP-IAT).   "
25869|NCT02947074|"     Rationale: Healthcare professionals face a growing burden of responsibilities and work     overload which may cause psychological suffering expressed by burnout, depression and other     negative psychological variables. Personal behavioral strategies may facilitate the coping     process. To maintain these positive characteristics, it is necessary that one decouples from     automatic thoughts, habits and patterns of unhealthy behaviors, leading to behavioral and     physiological regulation, through mindfulness techniques. More specifically, Yoga is an     ancient Indian philosophical and practical system and its ultimate goal is to calm the human     mind, and increase vital capabilities. In addition to the ethical precepts of Yoga, practices     involve asanas (postures), pranayama (breathing exercises) and dhyana (meditation). Many     studies have shown the positive effects of Yoga and meditation on psychometric variables,     however, there are few which address the effectiveness of Yoga on improving psychometric     variables of health care professionals. Thus, aiming to reduce the symptoms that health care     professionals experience when they are under burnout, this study intends to use Yoga     meditation, which may enable the professional to experience decoupling of harmful feelings,     improving, firstly, one's own inner self-relationship and therefore, with patients and their     families.      Objective: To investigate the effects of a 8-week yoga meditation program on psychometric and     physiological variables of Pediatrics health professionals.      Methods: randomized controlled clinical trial. Participants: 60 health professionals from the     Pediatrics Department of a tertiary hospital from Federal University of São Paulo (UNIFESP)     will be randomized to meditation or control (waiting list) groups. Subjects of the meditation     groups will have 2 30 min classes a week.      Evaluations: Psychometric and physiological variables will be accessed at study entry     (baseline) and after its completion (8-weeks).      Statistical Analysis: mixed general linear model (intervenient factors: groups - meditation     vs. control and moment - baseline vs. 8-weeks). Significance accepted with p<0.05.   "
25870|NCT02947061|"     To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With     Advanced Breast Cancer first-line treatment   "
25871|NCT02947048|"     This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively     randomized, placebo controlled patients and 5 open label patients at either 100 tid or 200     tid dosing for 28 days. The open label patients will be assessed for the purpose of     understanding PK/PD and to determine if there are any EKG changes associated with the     administration of L1-79. Additional safety information will be provided by the 30 patients     randomized 2:1 active:placebo.   "
25872|NCT02947035|"     The research study consists of the participant agreeing to 1) the use of preoperative     molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective     collection of medical record data related to treatment of thyroid cancer.   "
26037|NCT02944890|"     The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting     balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment     and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis     compared with a product of the same category (SeQuent® Please).   "
25920|NCT02946411|"     The study is designed to test if there is any correlation between the glucose levels in the     postoperatory period and the length of hospital stay.   "
25874|NCT02947009|"     Exercise-induced paradoxical vocal fold motion disorder (E-PVFMD) - which severely impacts     the lives of up to 1 million adolescents in the U.S. annually - is under- or mis-diagnosed in     as many as 80% of cases, leading to ineffective, protracted periods of management.     Additionally, what makes those with the condition different from those at risk for the     condition (e.g., playing sports/engaging in athletic activity within a competitive athletic     environment) is unclear. The goals of this proposed study are to address this diagnostic     challenge by (1) pursuing a previously published preliminary taxonomic algorithm for the     clinical identification and classification of EPVFMD, and by (2) elucidating potential     underlying mechanisms driving this clinical presentation. Study outcomes will improve     sensitivity and specificity of diagnosis protocols for PVFMD, thereby reducing prevalence of     misdiagnosis and improving clinical management in individuals with this disorder in the     future. Outcomes will also be used to create preventative care measures for adolescents at     risk for the condition.   "
25875|NCT02946996|"     The purpose of this study is to look at the effects that the study drugs (metformin and OPC)     have on AGE levels in patients with prostate cancer.   "
25876|NCT02946983|"     The investigators will test whether a subliminal, intragastric dose of fructose is able to     influence the emotional state at the behavioural and neural level, as has been previously     shown for fatty acids. They will also examine the potential involvement of gut peptide     release. Based on previous research using fatty acids, an attenuating effect of fructose     compared to placebo on the induced negative emotional state is hypothesized at the     self-report as well as the brain level.   "
25877|NCT02946970|"     The investigators aim to study the brain mechanisms underlying the effect of subliminal (not     consciously perceived) intragastric administration of bitter tastants on hunger and food     intake, which was previously found. The investigators will assess brain activation patterns     after an acute intragastric administration of Quinine-hydrochloride versus saline on two     different test days, and will simultaneously assess a putative role of altered gut peptide     release in these effects. The hypothesis is that intragastric infusion of a bitter agonist     will decrease the activity in homeostatic and hedonic brain regions and that this effect is     mediated by gut peptide release.   "
25878|NCT02946957|"     Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also     experience significant sleep disturbance. This randomized trial will determine whether a     telephone-based cognitive behavioral treatment targeting insomnia in older adults with     chronic severe OA-related insomnia and pain results in substantially greater reductions in     insomnia severity and in related improvements in pain, fatigue, mood, quality of life and     healthcare costs compared to telephone-delivered education (attention control) about     insomnia. The trial will test an intervention that if demonstrated to have long term efficacy     is scalable and has the potential for wide-scale deployment in healthcare systems.   "
25879|NCT02946944|"     Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in     the treatment of patients with intermediate-high risk of pulmonary embolism   "
25880|NCT02946931|"     To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under     Japanese clinical condition   "
25881|NCT02946918|"     In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than     the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and     more unpredictable TSH (thyroid stimulating hormone) levels.      The investigators therefore hypothesize that following thyroidectomy for Stage I/II     differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more     predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone     levels in the postoperative period.      The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules     to tablet form for TSH suppression following thyroidectomy for presumed stage I/II     differentiated thyroid cancer.   "
25882|NCT02946905|"     Cognitive impairment is a poorly understood, serious, and emerging complication for adult     patients with sickle cell disease. Because there is extensive microvascular damage from     oxidative damage in sickle cell disease, the investigators hypothesize that this is also     present in the cerebral microvasculature to cause cognitive impairment. The investigators     plan to test this by correlating markers of inflammation and oxidative damage with cognitive     performance and 7 Tesla brain MRI microvascular findings in these patients, with the long     term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle     cell disease.   "
25883|NCT02946892|"     This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart     operation. All participants will receive carvedilol and placebo for 12 weeks. Exercise tests     will be performed at the end of each 12 week period.   "
25884|NCT02946879|"     This study is a longer-term follow-up study for patients who have been administered     AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation     trial in adults and children with retinal dystrophy associated with defects in RPE65.   "
25885|NCT02946866|"     The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage     in adult patients with cerebral cavernous malformation with the goal of informing the     treatment plan.   "
25886|NCT02946853|"     Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for     patients with heart failure with reduced ejection fraction and specific indication. However,     many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately     30-36% of CRT patients are in atrial fibrillation (AF).   "
25887|NCT02946840|"     Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and     effective technique for obtaining samples from pancreatic masses. A new core biopsy needle     has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to     achieve a core for histology evaluation and the interchangibility of needle size using the     same needle shelter and different needle sizes.   "
25931|NCT02946268|"     The purpose of this study is to determine the ideal delivery of local anesthetics for pain     control when using continuous interscalene peripheral nerve catheters for shoulder surgery.      The study will be conducted in three stages. In the first stage the ideal bolus volume of     ropivacaine will be determined. In the second stage the optimal rate of delivery of the bolus     (infusion rate) will be determined. Finally, once both the ideal volume and infusion rate has     been determined, the optimal interval between boluses of local anesthetic will be determined.   "
25890|NCT02946801|"     The accumulation and maturation of oral biofilm in the gingival margin is widely recognised     to be the primary aetiological factor in the development of chronic gingivitis. Based on this     association, the current treatment of gingivitis is focused on biofilm disruption, which will     normally include mechanical processes, both professionally and at home. However, for     patients, it is not easy to achieve a proper level of plaque control. The efficient plaque     control techniques are very time consuming and require a special motivation and skills for     their optimum use. It was at this point where mouthwashes become important, due to the fact     that they include diverse types of antimicrobial agents to complement the results of     mechanical oral hygiene measures.      The essential oils have been presented as a realiable alternative to the gold Standard     (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain.     Some years ago, a new alternative without alcohol has been launched to the market. This     formulation has not been already deeply tested specific antiplaque studies in which the     structure of the biofilm remained intact.      The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents     (based on an essential oils formulation with and without alcohol) in the short term with a     posterior analysis on non-destructured biofilm with Confocal Laser Scanning Microscope     combined with fluorescence staining.   "
25891|NCT02946788|"     This is a single center open label study intended to provide photo documentation and time to     response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to     severe non-nodular inflammatory acne vulgarism.   "
25892|NCT02946775|"     To define the etiologic agents of community acquired bacteremic syndromes (defined as     septicemia, bacteremia, pneumonia and/or meningitis) in a malaria endemic setting.   "
25893|NCT02946762|"     At correctional facilities in Zambia and South Africa, a cross-sectional study design will be     used to characterize the full continuum of integrated HIV/TB care under Treatment as     Prevention (TasP), and will enrich this approach by: 1) using individual-level cohort data     for HIV-infected inmates to assess ART uptake under TasP/Universal Test and Treat (UTT), as     well as 6-month virological suppression and retention in care for inmates initiating ART; and     2) mixed methods to identify health-system, corrections-related socio-cultural and     individual-inmate barriers to and facilitators of TasP/UTT to refine TasP implementation; and     3) conducting a retrospective chart review using routine data from Ministry of Health     registers to reconstruct an approximate HIV and TB cascade for all inmates (HIV-infected and     HIV-uninfected) at 3 and 12 months into TasP/UTT implementation.   "
25894|NCT02946749|"     As the two-child policy implementation, caesarean women's clinical pregnancy is a huge     problem again, Especially the placenta planting abnormal disease is a serious threat to the     maternal health and life. Through this research, the investigators can obtain relevant     epidemiological data and provide objective data for the department of public health policy;     Predicting an placenta abnormal planting early diagnosis model was constructed, it will fill     the blank in this field, and high-risk groups in the early stages of pregnancy will be taken     proper disposal, the related complications will be reduced to ensure the safety of maternal.   "
25895|NCT02946736|"     This study is a randomized controlled trial that will assess the effects of (1) the     Family-Supportive Supervisor Behavior (FSSB) and Sleep Leadership training and (2)     sleep/cognitive effectiveness feedback intervention on health and well-being among full-time     employees in the Oregon National Guard, their supervisors, and their families. The     interventions involving both health protection and health promotion are expected to     contribute to improvements in employees' and their supervisors' sleep, risk behaviors, mental     and physical health, and injury, as well as employees' and their spouse/partners' family     experiences, health and well-being, and workplace outcomes.   "
25896|NCT02946723|"     Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary     urgency, usually accompanied by frequency and nocturia, with or without urgency urinary     incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The     SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The     device include IPG (implantable programme generator) and lead. In the initial test phase, 1st     stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This     allows your doctors and you to assess your initial response according to your voiding dairy     and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.      X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real     time visual guidance ,easy to operate by doctors and a radiation free option to challenge     anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and     dedicating to developing better guidance technique in surgery.      The study here compare the efficacy and safety of ultrasound versus X ray guidance technique     in SNM.   "
25897|NCT02946710|"     This research will be achieved by the assessment of p75NTR-ECD expression (total and linked     to different species of Aβ (Aβ1-40 and Aβ-1-42)) within the cerebrospinal fluid (CSF) of     patients with AD dementia, mild cognitive impairment (MCI) due to AD, frontotemporal dementia     and non-neurodegenerative dementia.   "
25898|NCT02946697|"     This study is a randomized controlled trial (RCT) to assess the impact of a culturally based     social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer     survivors.   "
25899|NCT02946684|"     This project seeks to determine whether estradiol suppression achieved with adjuvant     treatment with an aromatase inhibitor improves end-follicular and luteal phase parameters     during IVF. 128 patients will be randomized to either placebo or active treatment.   "
25900|NCT02946671|"     To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and     ONO-4538 (anti-PD-1).      To assess the behavior of immune cells in peripheral blood and tumor.   "
25901|NCT02946658|"     Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized     by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen     tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and     interference with oxygen-carbon dioxide exchange.      Air pollution and tobacco smoking are felt to be the most common cause of these issues.     Diagnostic testing is based on poor airflow measured by lung function studies and whose     symptoms do not improve much with antiasthma bronchodilators.      Study is an interventional study to document the safety and efficacy of use of AD-cSVF in     chronic broncho-pulmonary disease groups.   "
25906|NCT02946593|"     The purpose of the study is to examine the feasibility of the program and data collection     protocol to plan a multisite clinical trial. The program, Stroll Safe, an outdoor fall     prevention program, will take place in the lab space of the New York University occupational     therapy department and in the surrounding neighborhood.      Twenty-four people who meet the inclusion criteria will be enrolled after informed consent.     Recruitment will include follow up with people who expressed interest in the fall prevention     program during a survey study conducted by the PI, and interested members of community-based     programs for seniors who have agreed to be community partners for this study. Twelve     participants will be assigned to the 7-week program and 12 will receive written information     on outdoor fall prevention (control group).      The topics addressed in the once a week, 7-week outdoor falls prevention program, for which a     treatment manual has been developed, are based on the results of a survey conducted of     community dwelling older adults that identified gaps in knowledge and use of prevention     strategies, and the related literature. The program includes pre-set modules, however,     participants will be able to voice individual concerns and problem-solve solutions during     group discussions. Using an ecological perspective, the Health Belief Model, and problem     solving theory as a guide, the intervention will include a didactic component, group problem     solving, practical application of strategies, and self-advocacy regarding reporting problems     to the city.      Analysis will primarily focus on process measures.Post-intervention, semi-structures     interviews will be conducted and analyzed to assess strengths/limitations of the program and     participant's attribution of any behavioral changes to the intervention. Although statistical     significant is not anticipated in this small feasibility study, repeated measures ANOVA will     be used to examine changes in Falls Efficacy Scale-International (FES-I), Outdoor Falls     Questionnaire (OFQ) and Falls Behavioral Scale for the Older Person (FaB) scores from pre to     post-test for the treatment and control groups. Effect sizes (Cohen's d) will also be     calculated. Change in number of stumbles, trips, slips, and falls before and after the     program will also be analyzed.      Data will be collected on falls self-efficacy and strategy use at study enrollment     (Baseline), after completion of the 7 week program (1st Post-test), and at 2 months     post-program completion (2nd Post-test). Participants will be asked to keep daily diaries of     stumbles, trips, slips, and falls from the time they enroll in the study until two months     following the completion of the program.   "
25907|NCT02946580|"     Constipation is a known complication of the postoperative period after spinal surgery, where     prescription pain medicines called opioids are traditionally used in high doses for the     treatment of surgery-related pain. The goal of this study is to determine the effectiveness     of Movantik (naloxegol)—a FDA-approved drug used to treat constipation that is caused by     opioids—in preventing constipation in patients undergoing spinal fusion surgery at MGH.   "
25908|NCT02946567|"     The investigators are studying the educational potential of games, with the goal of     developing a game to improve learning and promote healthy hearing behaviors.      The project is looking for adolescents and young adults that play games to share their     experience and learning from playing games.      The investigators ask participants to fill out an enrollment form/informed consent, complete     surveys on healthy hearing habits, and play a game provided by the project.      This projects aims the development and evaluation of a game to educate teenagers and young     adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy     hearing behaviors with the potential to improve hearing health care.   "
25909|NCT02946554|"     The study will assess the safety of two dose regimens of HepaStem in Patients with ACLF up to     Day 28 of the active study period.   "
25910|NCT02946541|"     This is a randomized, double-blind, placebo-controlled, phase III clinical trial to     investigate the efficacy and safety of evogliptin after oral administration in patients with     type 2 diabetes who have inadequate glycemic control on diet and exercise.   "
25911|NCT02946528|"     Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable interest     amongst nephrologists. Several publications have provided assurances that urgent-start PD is     indeed feasible and can serve patients well; however, most of the studies have small sample     sizes, retrospective design, and the impact of the urgent-start dialysis modality on outcome,     especially on short-term complications, has not been directly evaluated. Therefore, we     started this multi-centered, prospective, interventional study compared the dialysis-related     complications and survival rate directly between urgent-start PD and HD groups with a large     sample to determine the feasibility and safety of urgent-start PD as an alternate initial     modality of dialysis for patients who require urgent initiation of dialysis therapy.   "
25912|NCT02946515|"     This study is looking at the feasibility and efficacy of using SIMmersion's PeopleSim     technology to train providers through role playing simulations to effectively conduct     discussions with parents to provide intervention for, and reduce the likelihood of     progression to childhood obesity.   "
25913|NCT02946502|"     The purpose of this study is to test the association between ICU acquired weakness as     evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning     outcome   "
25914|NCT02946489|"     Cannabis use disorders remain a significant public health problem. The pharmacological     facilitation of behavioral treatment represents a promising strategy for addressing     disordered cannabis use. Cannabis use disorders are recognized to be associated with various     vulnerabilities that complicate the course of treatment and that may be amenable to glutamate     modulators. The purpose of this randomized, double-blind, controlled trial is to test various     glutamate modulators in conjunction with motivational enhancement therapy (MET) and     mindfulness based relapse prevention (MBRP) for cannabis use disorders.   "
25961|NCT02945878|"     This is a prospective, observational study to analyze the clinical and dosimetric factors     about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal     carcinoma patients and try to find the indicators for acute radiation oral mucositis.   "
25915|NCT02946476|"     To better understand the public health prognostic impact of noncardiac chronic illnesses, we     explored the attributable risk of noncardiac comorbidities on outcomes between heart failure     patients with reduced ejection fraction (HFREF) and heart failure patients with preserved     ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted     hazard ratio (HR) and the population attributable risk were used to compare the contributions     of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high     attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary     disease, diabetes mellitus, and peripheral artery disease. These findings were similar for     HFrEF and HFpEF groups. Interaction analysis confirmed similar results.   "
25916|NCT02946463|"     The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients with     PNH who have not previously used a complement inhibitor.   "
25917|NCT02946450|"     The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT     scanning patients   "
25918|NCT02946437|"     Feasibility and safety of short term application of sevoflurane in patients with SAH treated     with aneurysm coiling or clipping in the setting of a neurointensive care unit.   "
25919|NCT02946424|"     This is a double blind, randomized, placebo -controlled clinical trial with the primary goal     of determining the osteogenic benefits of simvastatin in acute SCI.   "
25922|NCT02946385|"     The purpose of this study is to compare the effectiveness of 2 (given at 0, 2 months) or 3     (given at 0, 2, 6 months) doses of the GSK MenABCWY vaccine administered to healthy     adolescents in study V102_15 (NCT02212457), against a panel of randomly selected U.S. N.     meningitidis serogroup B invasive disease strains at 24 months after the last meningococcal     vaccination in V102_15 (NCT02212457) and response to a booster dose.   "
25923|NCT02946372|"     Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects people     aged over 60, and twice common in women than men.      The vast majority of cases are idiopathic. Without treatment, the macular hole evolves     through a series of stages until the extension of the diameter (up to 500 microns and higher     values). With a fully developed macular hole, patients complain of metamorphopsia and     decreased visual acuity.      This pathology has clearly benefited from advances in microsurgery and better understanding     of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana     vitrectomy with or without internal limiting membrane (ILM) peeling and placement of     intraocular gas tamponade.      The postoperative closure rate is close to 80%, but strongly depends on the initial     characteristics of the hole, its diameter remaining the main prognostic factor. Thus for     macular holes <400 microns, the closure rate is close to 92% dropping to 56% for macular     holes above 400 microns. In case of surgical failure, one or more reoperations can be     proposed, but with a lower closure rate.      The quest for a surgical technique presenting a greater success rate is a common goal to all     retinologists.      Here the investigators propose a new surgical technique, derived from the FLAP method, and     consisting of an inner limiting membrane transposition.      The objective of this study is to evaluate the feasibility of a new surgical technique for     the treatment of macular holes already operated but without macular hole closure, allowing     these patients a new therapeutic alternative. The success of this technique will be confirmed     by detecting postoperatively the presence of the transposed internal limiting membrane into     the foveal region.   "
25924|NCT02946359|"     This is a phase II, prospective, single arm, non comparative study with crizotinib combined     with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK     translocation or ROS1 translocation or MET amplification   "
25925|NCT02946346|"     Most genital infections by human papillomaviruses (HPV) are asymptomatic or benign and clear     within a few months or years. There infections are much less studies than chronic infections,     even though they represent the main reservoir for the virus. The goal of this project is to     decipher the kinetics of the virus and of the host immune response in acute HPV genital     infections in your women. This will be performed by following women longitudinally and     regularly in order to measure variations in virus load, immune cell count, cytokine     concentration and antibody titers. The investigators will also investigate the interaction     between these kinetics and host genetics and host vaginal microbiota   "
25926|NCT02946333|"     Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for     Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this     protocol can participate. The participating patients must sign an informed consent, which the     investigator who will collect the study variables in an electronic case report form (eCRF)     will provide to them. The investigators must recruit at least 450 patients in a 24-month     period.   "
25927|NCT02946320|"     The purpose of this study is to determine the optimal way of predilatation for BVS     implantation.   "
25928|NCT02946307|"     The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel     eluting balloon in the treatment of Chinese patients with coronary heart disease and small     vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.   "
25929|NCT02946294|"     The purpose of this study is to compare the analgesic profile of modified pectoral nerves     block and serratus plane block in patients undergoing mastectomy.   "
25930|NCT02946281|"     The primary objective of Do CHANGE is to develop a health ecosystem for integrated disease     management of citizens with high blood pressure and patients with ischemic heart disease or     heart failure. The system will give them access to a set of personalized health services in a     near real-time fashion. This disruptive system will incorporate the behaviour change methods,     such as Do Something Different, in conjunction with new innovative wearable/portable tools     that can monitor behaviour and clinical parameters in normal living situations.   "
25932|NCT02946255|"     The investigators propose to examine the effectiveness of a brief intervention that might     better facilitate the transition into the community for people with schizophrenia. The     intervention is called the Welcome Basket. It involves Peer Support Workers connecting with     and supporting hospitalized individuals in the days before discharge and again in the     community in the first month immediately following discharge. The investigators will compare     the outcomes of discharge from hospital as usual with the full version of the welcome basket     and a preliminary test of an abbreviated 2 visit version of the intervention.   "
25933|NCT02946242|"     Ultrasound devices components and accessories are under continuous development in order to     optimize, validate and improve the devices, including improving the quality of images. In     this study, GEHC proposes to collect data in order to achieve the following        1. Aim 1: Perform iterative evaluations of the device (including features, accessories and          components) to optimize device performance, assess feasibility of new features, and to          perform testing necessary to support product and technology development;        2. Aim 2: Perform activities to support design validation and/or to confirm user          requirements and specifications have been met, as per design controls and other          applicable requirements;        3. Aim 3: Evaluate device complaints and analyze potential causes. There is no animal or          phantom model that is adequate to accomplish these aims; therefore human subjects are          required.      Due to the inherently varied nature of study data, specific data points will be recorded on a     per-case basis and the study final report will summarize at minimum number and type of study     scans conducted. Electronic image data may be collected. The number and type of safety     issues, including adverse events (AEs) and serious adverse events (SAEs) will be reported.     Unexpected device issues that occur outside of expected and controlled engineering     optimization will be reported.   "
25934|NCT02946229|"     The purpose of this study is to enable longitudinal data collection of a library of     ultrasound images and associated case data in a diseased population with varied sonographic     findings. This data is required to support future engineering development of new ultrasound     technologies.   "
25937|NCT02946190|"     This is a phase II, randomized double-center, and observer-blind controlled pilot vaccine     trial in 11 to 15 years old healthy subjects to assess the immunogenicity of the genetically     detoxified pertussis toxin (rPT) included in a novel acellular pertussis vaccine (Pertagen®)     manufactured by BioNet-Asia when delivered by the intramuscular route to adolescents     previously primed and boosted with chemically-detoxified PT, along with Td-pur® and in     comparison with that of Boostrix® dTpa.      At Day 0, eligible volunteers will undergo a venous bleed for the determination of baseline     values and enter the randomization scheme, being allocated to one of two groups: A (Pertagen®     + Td-pur®), B (Boostrix® dTpa).      Randomized participants will receive one dose of Pertagen® and Td-pur® (Group A) or 1 dose of     Boostrix® dTpa (Group B) by intramuscular injection in the deltoid. All subjects will be     observed in the Plateforme de Recherché Pédiatrique for 30 minutes after immunization.      Post-immunization local and systemic reactions will be followed up for 7 days after     immunization. Adverse events will be followed for 28 days after immunization.      At Day 28, a second visit (study end visit) will take place for safety evaluation and blood     draw for immunogenicity evaluation.      Blood draws performed on Day 0 (Baseline) and Day 28 will be used to evaluate immune response     to study vaccines.      The primary statistical analysis will be performed with visit 2 (Day 28) data to compare the     immunogenicity and safety of one dose of Pertagen®, given simultaneously with Td-pur®, to     those elicited by Boostrix® dTpa.   "
25938|NCT02946177|"     In this study the investigators propose a randomized controlled trial to evaluate the effect     of influenza vaccination on clinical pregnancy rates among women undergoing in vitro     fertilization as donor egg recipients.   "
25939|NCT02946164|"     This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the     concept of gamification. The objective of the program is to encourage young men who have sex     with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs)     and to adopt safer sexual behaviors, with the ultimate goal to decrease HIV and STI     incidence. Gamification is the application of game elements, like points, badges, and     rewards, to non-game settings.   "
25940|NCT02946151|"     The study is a two-phase study, which aims to investigate the performance of a novel     electrode type in detecting epileptic seizures. The electrode is designed for subcutaneous     implantation with long-term monitoring in mind.   "
25941|NCT02946138|"     The aim of this research project is to assess the efficacy and toxicity of hypofractionated     carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for     the treatment of hepatocellular carcinoma   "
25942|NCT02946125|"     This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601     for dilation of the pupil. A single micro dose of EYN-1601 will be compared to single doses     of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.   "
25943|NCT02946112|"     The aim of this study is to assess the relationship between shoulder position and the     presence of pain in volleyball players. To do this, will be measured pain sensation and the     position of acromion process   "
25944|NCT02946099|"     Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc     reciprocating files versus that resulting after using ProTaper Next rotary files in     asymptomatic necrotic molars.   "
25945|NCT02946086|"     This study aims to investigate the changes induced by HABIT-ILE in impairments, activity and     participation of children with unilateral CP, as well as neuroplastic changes induces by the     treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation     will be measured.   "
26334|NCT02941003|"     The purpose of this study is:        1. To establish a set of diagnostic criteria of intraoperative frozen section of early          stage lung adenocarcinoma, including clinicopathologic and molecular characteristics.        2. To assess its clinical usefulness in guiding surgical procedure for early stage lung          adenocarcinoma.   "
25946|NCT02946073|"     This study will be a Phase III, placebo-controlled, multicenter study with an     enriched-enrollment withdrawal design to evaluate the efficacy and safety of CAM2038 in     opioid-experienced subjects with moderate to severe CLBP that requires continuous,     around-the-clock (ATC) opioid treatment. The study will comprise 5 phases: a Screening Phase     (up to 2 weeks), a Transition Phase (up to 2 weeks), an open label Titration Phase (up to 10     weeks), a Double-Blind Phase including a Final Study Visit (12 weeks), and a Follow-up Phase     (4 weeks). The overall duration of participation will be up to 32 weeks, from Screening Phase     to Follow up Phase, including 12 weeks of double-blinded treatment.   "
25947|NCT02946060|"     This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without     Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants     will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or     Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of     these interventions on mood, perceived exertion and dissociative attention among patients     participating in cardiac rehabilitation.   "
25948|NCT02946047|"     The goal of this study is to determine the safety and tolerability of Ixazomib in HIV     infected patients who are on a stable regimen of ART that suppresses HIV replication. A     secondary goal is to determine the effect of ixazomib on the size of the HIV reservoir.   "
25949|NCT02946034|"     Single arm, open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin     for adults with chronic kidney disease and hepatitis C.   "
25950|NCT02946021|"     Assessment of lymphatic structure and function pre- and post- treatment and during recovery     in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging:     Response to ICD therapy in HNC Patients.   "
25951|NCT02946008|"     This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of     neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate     cancer patients.      Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks     total.   "
25952|NCT02945995|"     The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients     previous treated with periacetabular osteotomy   "
27054|NCT02931617|"     Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients     undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery     (lobectomy etc, open or VATS) and cardiac surgery   "
25953|NCT02945982|"     Portal hypertension is a common pathology in chronic liver disease, particularly in liver     cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The     basic reason for portal hypertension in HBV is the largely deposition of hepatic     extracellular matrixes which causes high pressure in liver vessels. One of the most common     symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective     inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic     Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the     regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals     therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu     has been found to enhance the degradation of collagens in fibrotic liver and have a good     action against liver fibrosis in patients with chronic hepatitis B. However, there are no     high quality clinical evidences which can demonstrate if the combination of anti-viral and     anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate     and bleeding rate of gastroesophageal varices.   "
25954|NCT02945969|"     The proposed randomized controlled trial will test the effect of dietary sodium reduction on     albuminuria in patients with proteinuric chronic kidney disease. Results from this study will     clarify the role of dietary sodium reduction in management of patients with proteinuric     chronic kidney disease and its potential to halt the progression of chronic kidney disease.   "
25955|NCT02945956|"     Portal hypertension is a common pathology in chronic liver disease, particularly in liver     cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The     basic reason for portal hypertension in HBV is the largely deposition of hepatic     extracellular matrixes which causes high pressure in liver vessels. One of the most common     symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective     inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic     Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the     regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals     therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu     has been found to enhance the degradation of collagens in fibrotic liver and have a good     action against liver fibrosis in patients with chronic hepatitis B. However, there are no     high quality clinical evidences which can demonstrate if the combination of anti-viral and     anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate     and bleeding rate of gastroesophageal varices.   "
25956|NCT02945943|"     Our purpose was to examine the combined effects of thrust mobilization of the proximal and     distal ankle joints in conjunction with a six-week rehabilitation program on ankle function     in subjects reporting chronic ankle instability (CAI).   "
25957|NCT02945930|"     To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of     Esophagogastric Varices.   "
25958|NCT02945917|"     The use of esophageal balloon catheter to estimate pleural pressure has gained renewed     popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more     pathophysiological-based approach to ventilator strategy in acute respiratory distress     syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter     derived parameters can be influenced by several patient-related or technical-related factors.      During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and     derived measurements obtained using different esophageal balloon calibration volumes.   "
25959|NCT02945904|"     Purpose of this clinical trial is to improve prediction of outcomes from surgical     intervention in patients with Primary aldosteronism, and evaluate the merits of non-invasive     metomidate PET CT versus adrenal vein sampling in the diagnosis of surgically correctable     aldosteronism.   "
25960|NCT02945891|"     Study aims to support development of evidence based health care in Norway through evaluating     recently proposed technological improvements in cervical cancer control before their routine     use. SESAM II study evaluates the accuracy of vaginal self-sampling for high risk human     papillomavirus (hrHPV) testing compared with a physician-taken sample.   "
25962|NCT02945865|"     It is estimated that 45-80 % of nursing home residents have substantial pain at any given     time. Residents with impaired cognition have been found to report chronic pain more often,     more frequent and more severe, compared to residents with normal cognition. Approximately 3/4     of permanent residents in nursing homes in Norway have developed dementia. The burden of     dementia is often compounded by painful conditions. Despite over a decade of research on the     subject, inadequate pain assessment and management remain significant problems among     institutionalized older adults, with and without dementia. The poor pain management in     patients with dementia has been attributed, at least in part, to difficulties with, and lack     of, pain assessment in this population. Therefore, this study seek to determine the effect of     regular pain assessment.   "
25963|NCT02945852|"     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and     etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive     small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is     no standard treatment recommendation for this group of patients who failed to second-line     therapy and had good performance status. Apatinib has been approved as a second-line     treatment for advanced gastric cancer. Several phase III clinical studies of non small cell     lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less     toxic side effects and better patient tolerance. However, the clinical application of     apatinib in small cell lung cancer is still lack of evidence-based medicine. And this     clinical trial is designed to prospectively investigate the efficacy and safety of apatinib     in refractory or recurrent ED-SCLC patients in our center.   "
25971|NCT02945748|"     Hemodynamically unstable ventilated PICU & PCICU patients, which a decision for commencement     in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic     measurements will be carried out before and after therapy have been made, including customary     hemodynamic parameters, echocardiography and USCOM studies.      All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction.     Trend in USCOM parameters will be compared to echocardiography CO parameters.   "
25972|NCT02945735|"     The purpose of this study is to determine whether giving gaze-contingent feedback is an     effective attention modification procedure, helping in the treatment of Major Depressive     Disorder (MDD)   "
25964|NCT02945839|"     Collectively, evidence shows that a combination of medication and behavioral therapy is most     effective for migraine care. The ED is a critical point of contact with the health care     system for many migraine patients; in current practice, it is a missed opportunity to     initiate and establish a comprehensive migraine management paradigm. Behavioral headache     treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral     therapy (CBT)) are effective migraine treatment options that are essentially free of side     effects. PMR has also been successful as a technique that patients can do independently.     Studies have shown that combination pharmacological-behavioral therapy is most effective for     migraine treatment.      Several aspects of this study are innovative, including: 1. Initiation of preventive     medication in a timely manner for migraineurs who present to the ED. 2. Introduction of     PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a     smartphone application-based product (a minimal contact based behavioral therapy) in the ED     setting to reduce headache disability, frequency, and intensity.   "
25965|NCT02945826|"     The purpose of this study is to investigate the applicability of urokinase plasminogen     activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of     glioblastoma.   "
25966|NCT02945813|"     The main objective of the trial is to determine if salvage radiotherapy (SRT) plus metformin     is superior to SRT alone in the endpoint of time to progression after prostatectomy failure.   "
25967|NCT02945800|"     The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the     formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing     sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time     during and after treatment that their disease does not get worse. Researchers also want to     find out if nab-paclitaxel combined with gemcitabine is safe and tolerable.   "
25968|NCT02945787|"     Results of a recently completed National Cancer Institute (NCI) funded trial of an     intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24-     month follow-up period, further supporting the utility of extended self-help for promoting     and maintaining tobacco abstinence. Investigators have recognized that wide-scale     implementation, and therefore public health impact, would be enhanced by the availability of     a Spanish-language version to reach the largest and fastest growing ethnic minority     population of smokers.      The goal of this study is to address this gap by testing a Spanish-language version of the     validated self-help smoking cessation intervention. If demonstrated effective, the proposed     intervention would represent an easily disseminable and low-cost intervention with     significant public health impact for Hispanic/Latino smokers throughout the United States.     The aims of this project are to test the efficacy of a Spanish-language version of a     validated, extended self-help intervention for smoking cessation among Spanish-speaking     smokers against usual care control. Participants (N = 1240) recruited nationally will be     randomized to the two arms.   "
25969|NCT02945774|"     Neuroinflammation is increasingly implicated as a potential critical pathogenic mechanism in     a variety of neurologic and psychiatric disorders. This study will use hybrid PET/MRI imaging     to evaluate neuroinflammation and its relationship to cerebral perfusion in frontotemporal     dementia (FTD). Patients with FTD will be recruited from the Cognitive Neurology and Aging     Brain clinics at Parkwood Institute and will undergo neurocognitive assessment and MRI/PET     using the PET ligand FEPPA which binds to activated microglia, a marker of neuroinflammation.     Correlations will be conducted to determine whether abnormal neuroinflammation is present in     Frontotemporal dementia and whether differential patterns of neuroinflammation are present in     different FTD clinical and molecular subtypes, and to determine the relationship between     neuroinflammation, cerebral perfusion using arterial spin labeling MRI imaging techniques,     and indices of brain structure including volumetric and white matter analysis.   "
25991|NCT02945488|"     The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and     nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases     (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to     mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in     preconception women with IBD. The investigators hypothesize that the combination of     anti-inflammatory exercise and nutritional interventions will have a synergistic effect on     managing major symptomatic concerns associated with IBD, reducing inflammation, and improving     fertility status in preconception women with IBD, as compared to either intervention     independently.   "
25992|NCT02945475|"     This study is aimed at understanding neuroendocrine responses to different types of sugars     and how this influences feeding behavior among lean, obese and obesity prone individuals.   "
25993|NCT02945462|"     Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro     expansion under restricted culturing conditions.   "
25970|NCT02945761|"     Surgeons easily get wound infections. Most wound infections will be cured by applying     medicines and changing dressing in very short period of time. But some wounds are severely     contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna,     so changing dressing takes a very long time. In order to better change the dressing, it needs     to expose the wound thoroughly, which requires to completely open the healed skin, so the     healing will be slowed down. Some scholars lay stress on prevention. Wound infection control     concerns prevention--not therapy--of an infrequent but expensive kind of surgical     morbidity.(1.2)Some scholars think that the main armamentarium of the attack is the use of     topical anti-infectives, which invade the bacteria where they reside, and, consequently,     reduce their numbers and promote wound healing.(3)For example, silver is reemerging as a     viable treatment option for infections encountered in burns, open wounds, and chronic ulcers.     But it is expensive and is difficult to acquire silver-containing dressings. And Recent     findings, however, indicate that the compound delays the wound-healing process and that     silver may have serious cytotoxic activity on various host cells. (4) As High concentration     of sugar solution, honey appears to heal partial thickness burns more quickly than     conventional treatment (which included polyurethane film, paraffin gauze,     soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected     post-operative wounds more quickly than antiseptics and gauze.(5)This study involve the use     of another high-concentration of sugar solution (HCSS) to lavage infected wounds when     changing dressings.   "
25973|NCT02945722|"     S. aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis     (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently     shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of     staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal     sample the determination of carriage status (persistent, intermittent or non-carriers) among     patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus     infections however, multiples schedules of decolonization have been proposed to all S. aureus     carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We     showed that only 50% of HD centers in France propose screening and decolonization of S.     aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted     decolonization of S. aureus persistent carriers using mupirocin nasal ointment and     chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients     compared to the absence of decolonization using a randomized open study methodology.   "
25974|NCT02945709|"     The purpose of this study is to explore the efficacy of Attention Control Training for Post     Traumatic Stress Disorder (PTSD).      ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in     combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination     of ACT's efficacy in additional populations of patients with PTSD. Such extension of     treatment to other traumatic experiences raises the question of whether the threatening     content of the training material could be personalized for each patient.   "
25975|NCT02945696|"     The investigators will perform a prospective randomized study to compare the effectiveness of     laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with     ultrasounded guided abdominal wall blocks.   "
25976|NCT02945683|"     The purpose of this study is to evaluate in a randomized, double-blinded, controlled trial,     whether a new food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3     (Reuterin® D3) may improve the SCORAD in pediatric patients with mild to moderate atopic     dermatitis   "
25977|NCT02945670|"     The purpose of this study is to learn what women of childbearing age think of Long Acting     Reversible Contraception. A variety of myths regarding LARCs have been described in the     literature. This study is designed to asses women's cultural belief's regarding LARCs.     Investigators are looking to collect information from women in general, rather than solely     who are seeking contraception. Investigators will be recruiting women ages 18-45 years from     seven family health centers affiliated with UPMC. Participants will be asked to a attend a     60-90 minutes focus group session. During the session the facilitator will try to engage     participants in a discussion about contraception in general. They will also be asked to     complete a short demographic survey of 8-12 questions. Data from focus groups will be     assessed for recurring themes which will be used to create a cultural survey instrument that     will be used in the second phase of the study.   "
25979|NCT02945644|"     Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal     dosing is unknown. This study looks at what dose of trazodone has the best balance of     potential benefits to side-effects in people with obstructive sleep apnea who are either     starting on positive airway pressure therapy or not adherent to it. Participants will be     randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for     14 days. The investigators will monitor side-effects and adherence to positive airway     pressure therapy.   "
25980|NCT02945631|"     The purpose of this study is to establish the efficacy and toxicity of low dose     chemoradiotherapy after induction chemotherapy in patients with locally advanced HPV+     oropharynx cancer and establish prognostic factors that would apply to help select patients     for this treatment in the future.   "
25994|NCT02945449|"     Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of     erectile dysfunction in diabetic patients.   "
25982|NCT02945605|"     This study examines the effect of early vestibular rehabilitation on reducing physical     post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to     achieve medical clearance to return to activities such as sports and work activities. Half of     the participants will receive early vestibular rehabilitation added to standard of care,     while the other half will receive standard of care only.   "
25983|NCT02945592|"     The presented study investigates standardized visual cueing in reading and visual spatial     task as a treatment method for spatial neglect. In a randomized controlled design patients     receive either cued reading and visual spatial tasks (intervention) or treatment which is     unspecific to neglect (control).      In the intervention condition, patients with left-sided neglect receive intense training,     including reading and visual spatial task with standardized and adapted visual cueing by the     therapist. Improvements in reading and visual spatial tasks lead to a reduction of cues by     the therapist. Accordingly, the patient has to apply self-cueing over time in order to solve     the task.      For the control condition, all patients receive unspecific treatment without any standardized     adapted cueing implemented by the therapist.      To enhance the effectivity of cueing in reading and visual spatial tasks, the investigators     additionally conduct parietal transcranial direct current stimulation (tDCS) in those     patients without tDCS exclusion criteria (see exclusion criteria below).      It is hypothesised that systematic and adaptive therapeutic cueing leads to a significant     reduction of omissions of word and word parts in reading.   "
25984|NCT02945579|"     The goal of this clinical research study is to learn how often breast cancer recurs (returns     after treatment) in the breast in patients who have been treated with chemotherapy and have     had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence     of disease).   "
26026|NCT02945033|"     Four retrospective studies were recently published on efficacy of aspirin in patients with     surgically resected colon cancer. Two of these studies strongly suggested that aspirin used     in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation     could act as a targeted therapy with a major protective effect on the risk of recurrence. The     other two studies did not confirm the benefit of aspirin in this situation. These four     retrospective studies provide an insufficient level of evidence to demonstrate the benefit of     low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary as     recommended in the conclusion of these studies and meta-analyses to perform a randomised     prospective study to validate these data.   "
25985|NCT02945566|"     Colorectal cancer is the third most common tumour in the UK, Netherlands and Denmark with     41000, 14000 and 4000 new cases per year respectively. Standard primary radical Total     Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage     rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in     approximately 5-10% of cases while many more patients have a temporary stoma, some of which     are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic     tumours, may not be the optimal method of treatment for early screen-detected tumours and an     organ preserving strategy may generate significantly less morbidity without substantially     compromising oncological outcomes.      TREC was a randomised phase II trial to test the feasibility of randomisation between TME and     an organ preserving policy of short course pre-operative radiotherapy (SCPRT) delay followed     by transanal endoscopic microsurgery (TEM). STAR-TREC is a phase II feasibility study that     will evaluate whether it is possible to accelerate the patient recruitment attained in the     TREC study, to 4 per month in the first year of recruitment and 6 per month in the second.     This would demonstrate deliverability of a phase III study.   "
25986|NCT02945553|"     Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair     improves knee biomechanics and function, but neuromuscular dysfunction persist for years     despite rehabilitation, hindering resumption of normal activities, increasing risk of further     injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA).     Our goal in this research study is to evaluate the utility of neuromuscular electrical     stimulation (NMES), initiated following injury and maintained through the early post-surgical     period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active     control intervention of micro-electrical stimulation.   "
25987|NCT02945540|"     This study seeks to evaluate patient satisfaction within the patient therapeutic education     program gestational diabetes (multidisciplinary and multi-professional program) to see if     they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are     questioned on the skills acquired in everyday life, the effective support in personal     development, development of self-determination capabilities and communication with health     professionals.      This study must include all patients participating in the therapeutic education program for a     year and meeting the inclusion criteria.   "
25988|NCT02945527|"     Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no     additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis   "
25989|NCT02945514|"     Provide personally tailored dietary suggestions to participants based on the Personalized     Prediction Engine (patent pending) owned by DayTwo.   "
25990|NCT02945501|"     The purpose of this study is to determine if the enhancement of electroencephalographic (EEG)     slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO)     frequency, during a restricted period of nocturnal sleep, enhances the restorative properties     of that period of sleep and improves performance during a subsequent period of sleep     deprivation.   "
25995|NCT02945436|"     A sample of 600 young (15-25) men who have sex with men (MSM) and transgender persons living     in South-East Michigan's Detroit Metro Area (DMA) will be recruited through venue-based     sampling and online ads to examine the efficacy of adding a substance use brief intervention     (SUBI) to standard HIV prevention and care (SOC) for achieving gains in successful engagement     in HIV care. The investigators will partner with Detroit-area AIDS Service Organizations     (ASOs) to deliver the intervention.   "
25999|NCT02945384|"     This project involves the development of a scaled-up model of a successful dual-generation     intervention targeting attention, stress, and self-regulation in families attending Head     Start, and improvements of outcome assessments of the intervention. The investigators     hypothesize that families randomly assigned to receive the intervention, compared to families     not receiving the intervention, will show improved brain function for attention and     self-regulation and improved physiological function for stress regulation in both children     and their parents, improvements in child school performance and cognition, and improvements     in assessments of parent/family well being.   "
26000|NCT02945371|"     Insufficient inhibitory control is one pathway through which early adversity is related to a     range of problems including excessive alcohol use, tobacco use, and unhealthy eating. The     proposed research leverages a neurally informed model of inhibitory control and how it can be     improved to test the efficacy of a person-centered inhibitory control intervention in a     sample of mid-life individuals with early adversity. The knowledge obtained by this study     could be scaled into a flexible, low-cost, and wide-ranging intervention to remediate some of     the effects of early adversity on inhibitory control and thus a number of prevalent health     risking behaviors.   "
26001|NCT02945358|"     A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary     bypass increases not only cost of patient care but also morbidity and mortality of patients.     The ability to predict which patient has the tendency to have a prolonged ICU stay would help     in patient and resource management of the hospital. There are many predictive models aiming     at identifying patient at risk of prolonged ICU stay after cardiac surgery with     cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource     management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning     intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The     OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total     score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this     study was to re-validate the performance of OHIR score in the recent context.   "
26007|NCT02945280|"     This study will assess the safety and effectiveness of a drug called apixaban for the     treatment of upper extremity deep vein thrombosis (UEDVT) and clinically important bleeding.     Subjects will receive apixaban 10 mg by mouth twice a day for 7 days, followed by 5 mg by     mouth twice a day for a duration of 11 weeks. There will be a followup visit at 12 weeks for     all participants. A total of 375 are to be enrolled.      The study drug has been approved to treat blood clots. The study drug has not been studied     uniquely for the treatment of blood clots in the upper extremity however. Because it is     unknown whether it is effective to treat blood clots in the upper extremity, the principal     investigator cannot guarantee that there will be benefit to study subjects; however, it is     hoped that the information obtained from this research study will help treat patients in the     future.   "
26002|NCT02945345|"     The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area     and Severity Index (CDASI), established in 2008, is a one-site database study conducted at     the University of Pennsylvania. The database has yielded valuable information and clinical     insights into the pathophysiology, disease processes, including psychological responses,     treatments and quality of life associated with dermatomyositis. The CDASI database     incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated     outcome measure of disease responsiveness in patients, and other assessment tools, surveys     and patient information to help validate the clinical course and quality of life of patients     with dermatomyositis.      The CDASI database has led to publication of comparison studies of CDASI and other clinical     instruments and the effect of dermatomyositis on Quality of Life (QoL).      The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving     clinical changes, treatment modalities and patient response to a challenging disease. Data     will be analysed over a 5 years.   "
26003|NCT02945332|"     Specifically, the main objective of this pilot and feasibility study is to develop the     infrastructure that will be used in a larger study that would be proposed at a later date.     Hence, this study has two parts. Part A: To establish contacts, collaboration, and networking     to develop the infrastructure needed to conduct the study, Part B: To recruit eight subjects     (4 subjects randomly assigned to either a control group or intervention group) from a     low-income community in East Lubbock who are willing and able to participate in this pilot     study. The research team's central hypothesis is that the disease burden of obesity and     related co-morbidities could be attenuated within low-income communities by providing     incentive-based free access to a safe and convenient exercise facility and earned credit to     subsidize healthful food cost. The research team's secondary hypothesis is that the     anticipated decrease in disease burden will make the incentivized changes in lifestyle     cost-effective.   "
26004|NCT02945319|"     The study aims at developing and validating an integrated clinico-molecular model for an     accurate survival prognostication in newly diagnosed SMZL.      Already existing and coded tumor biological material and health-related personal data will be     retrospectively collected. Mutation analysis will be performed by targeted deep next     generation sequencing of tumor genomic DNA. Deletion of 7q will be assessed by FISH on nuclei     isolated from tumor tissues. Immunoglobulin gene rearrangement and mutation status will be     analyzed on tumor genomic DNA by PCR and Sanger sequencing. The methylation status of target     genes will be assessed by methylation specific PCR on tumor genomic DNA.      The adjusted association between exposure variables and OS will be estimated by Cox     regression. This approach will provide the covariates independently associated with OS that     will be utilized in the development of a hierarchical molecular model to predict OS. The     hierarchical order of relevance in predicting OS among covariates will be established by     recursive partitioning analysis. An amalgamation algorithm will be used to merge terminal     nodes showing homogenous OS. The discrimination capacity of the model will be assessed by     calculating the c-index. Relative survival analysis will be used to provide a measure of the     excess mortality experienced by patient's subgroups stratified according to the developed     hierarchical molecular models, irrespective of whether the excess mortality is directly or     indirectly attributable to the disease. The model developed in the training set will be     tested in the validation sets and the model performance (c-index) in the validation set will     be compared with that in the training set.   "
26015|NCT02945176|"     The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with     Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is intended     to be used together with the hand-held Mesograph reading device to telemetrically measure the     intraocular pressure (IOP) of patients with a BKPro.      The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in     patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the 12     month period beginning at implantation.   "
26016|NCT02945163|"     Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral     therapy in developing countries. Based on our previous data, we aim to evaluate whether     reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects     while not scarifying their virological efficacy.   "
26005|NCT02945306|"     Sleep disorder breathing (SDB) is a condition affecting 10% of children aged 2-6 years. It is     a combination of snoring most nights during sleep, patchy sleep, short periods of stopping     breathing (apnoea) and usually big tonsils. Most of these children get better with no     treatment by 8 years old. It has been suggested that having SDB mean that some children     concentrate and behave less well during the day and may learn more slowly than children who     don't snore. It has become common for many Ear, Nose and Throat (ENT) surgeons to take out     tonsils and adenoids (adenotonsillectomy) for this condition. Removing the tonsils and     adenoids (which are normally big at this age) means that most children quickly stop snoring     and seem to be cured. Unfortunately it is not clear if this operation makes any difference to     learning compared to just watching the child and letting them grow out of the condition     (watchful waiting).      There is no set treatment in the UK today. Children may be offered adenotonsillectomy or     watchful waiting; it is not know which, long term, is the right thing to do. Therefore the     investigators wish to do a study looking at these two different treatments to see if there is     a difference in children's learning over time between the two different treatments. The     investigators will look at children with SDB, measure their learning (and behaviour) and then     randomly select which children get one treatment or the other. They will then re-measure     learning (and behaviour) 7 months later to see if there is any difference between the two     groups. The investigators will also scientifically measure their sleep. This is possibly     quite a difficult study to do, the investigators are unsure whether families will agree to     take part and how easy it will be to measure learning with such young children (aged 2:6 -     5).   "
26006|NCT02945293|"     The purpose of this study is to examine the relationship between heavy alcohol use, pain, and     response to pain medication in older adults. We hypothesize that heavy alcohol use may impact     health physiology.   "
26025|NCT02945046|"     This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,     parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125     (Fremanezumab) versus placebo in adult patients for the prevention of ECH.   "
26008|NCT02945267|"     Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine     in overall survival (OS) with good tolerability for advanced pancreatic cancer in Asian     patients. It is also shown that nimotuzumab plus gemcitabine could improve OS and progression     free survival (PFS) in patients with unresectable pancreatic cancer. However, it is still     unknown whether nimotuzumab plus S1 would improve more to OS and PFS than single S-1.     Maintenance treatment, as a new treatment pattern, has also been tried in these patients     after first line treatment to improve the OS. Thus, this study is designed to compare     nimotuzumab plus S1 to placebo plus S1 as maintenance treatment in patients with locally     advanced or metastatic pancreatic cancer who has benefited from the first-line treatment of     gemcitabine combined with nimotuzumab and S1 (complete response+partial response+stable     disease).      Patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group     nimotuzumab plus S1 and group placebo plus S1. nimotuzumab/placebo: 400 mg/w, intravenous     infusion, Infusion time ≥ 60 min, d1, once every two weeks. S1: oral, 40 mg (Body surface     area<1.5 m2) or 60 mg (Body surface area>1.5 m2), d1-d14, every three weeks for a cycle.     Treatment interventions will be stopped under the conditions of disease progression or     intolerable toxic reaction or participants ask to quit. The primary endpoint is the time to     disease progression since randomization (TTP), secondary points include OS, 3 years overall     survival rate (OSR) and safety.   "
26009|NCT02945254|"     Insufficient and low-quality sleep is a major public health problem that has been linked to     motor vehicle crashes, industrial disasters, and medical and other occupational errors.     Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases     such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased     mortality, and reduced quality of life and productivity.      The number of people using sleep-inducing drugs to increase or improve sleep is steadily     increasing in the last few decades; however, the side effects of these therapies often     outweigh the benefits.      A few small trials and anecdotal findings suggest that continuous background (pink or white)     noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce     sleep onset latency.      In an attempt to find new, alternative solutions to increase sleep quality in people     suffering from insomnia, the investigators would like to test the effect of surrounding     filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.   "
26010|NCT02945241|"     Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough     achievement compared to creatinine clearance-guided vancomycin therapy in critically ill     patients.   "
26011|NCT02945228|"     The main objective of this study is to evaluate the safety and effectiveness of     paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic     hepatitis C virus (HCV) genotype 2 in daily practice in Japan.   "
26012|NCT02945215|"     Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301     and rituximab in patients with CD20+ B-cell Lymphoma   "
26013|NCT02945202|"     This study investigates the effects of trabeculectomy and combined phacoemulsification plus     trabeculectomy on corneal astigmatism.   "
26014|NCT02945189|"     This is a sample collection study, participants will be required to collect one (if last     menstrual period ≥12 months) or two (if last menstrual period <12 months) urine samples and     return them to the study site, together with collection sample information. Participants     having a menstrual cycle within the last 6 months will also be required to provide follow-up     information on pregnancy status and date of next menstrual bleed.   "
26017|NCT02945150|"     Proof of concept, open-label single center study for the donation of HCV positive kidneys to     HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission     upon transplantation.   "
26018|NCT02945137|"     The accurate diagnosis of H. pylori infection is an important step for establishing the     strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the     first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT     shows rapid result with good sensitivity and specificity. Several study reported that H.     pylori density was related to positive reaction time of RUT. However, there was no study     comparing the positive reaction times of RUT according to biopsy site, degree of gastric     atrophy, and intestinal metaplasia.   "
26019|NCT02945124|"     To investigate the effects of K Tape on walking pattern, muscle activity and motor     performance in children with and without developmental coordination disorder (DCD).   "
26020|NCT02945111|"     The purpose of this study is to assess whether the degree of anxiety experienced by women     undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced     by watching the procedure in real-time on a digital screen.   "
26021|NCT02945098|"     Sixty volunteers with a mean age of 21,8 ± 2,6 years participated in this study, randomly     distributed into one of the following groups: control, Kinesio taping group with tension in     the anterior arm region and Kinesio taping group without tension in the same region. All     subjects underwent an eccentric exercise protocol and three evaluations: before the protocol,     immediately after and 48h after protocol. The following variables were analyzed: sensation of     pain as the primary outcome; peak torque normalized by body weight; average peak torque;     total work and average power, using an isokinetic dynamometer. In addition, muscle activation     amplitude (Root Mean Square) and median frequency were recorded using surface     electromyography.   "
26022|NCT02945085|"     This study addresses how to achieve better outcomes for cognitively vulnerable     community-dwelling older adults and their families. Cognitive vulnerability means living with     dementia, depression, and/or a recent episode of delirium (the 3Ds). The investigators will     test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided     by nurse practitioners with expertise in geriatrics and geriatric psychiatry. Specific aims     are to determine Home Based Care Team effects on hospitalization or emergency department use,     and other outcomes including depression, disability, and quality of life.   "
26023|NCT02945072|"     The aim of this study is to investigate long-lasting or later behavioral changes in children     in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)   "
26024|NCT02945059|"     The aim of this study is to prospectively evaluate the tolerance and efficiency of a new     technique of preoperative selective portal vein embolization (PVE) in patients requiring     major hepatic resection.   "
26028|NCT02945007|"     The purpose of this study is to assess the relative bioavailability of 1 to 3 concept     formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess     the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678     when administered as a single oral dose of 500 milligram (mg) in healthy adult participants.   "
26029|NCT02944994|"     The purpose of this study is to examine effectiveness and implementation for the Unified     Protocol for the Transdiagnostic Treatment of Emotional Disorders in trauma exposed veterans.   "
26030|NCT02944981|"     The intrathecal administration of morphine is gaining popularity. It is easy to do and can     reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and     vomiting more than other methods providing postoperative analgesia. Patients suffering from     these side effects have to spend a longer period of time recovering in the hospital with high     cost of medical treatment.   "
26031|NCT02944968|"     The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical     study.   "
26032|NCT02944955|"     This is a clinical trial to determine the safety, recommended dose level (RDL), and infection     control of BLEX 404 Oral Liquid in combination with azacitidine in patients with     International Prognostic Scoring System (IPSS) intermediate-1 (int-1), intermediate-2 (int-2)     or high-risk myelodysplastic syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML).   "
26033|NCT02944942|"     General anesthetic technique plays a key role in most surgical procedures. This technique has     some complications especially postoperative nausea/vomiting (PONV). This complication can     lead to serious problems. Department of Anesthesiology has developed and implemented a PONV     prophylaxis guideline for high risk PONV patients but PONV still remains.   "
26034|NCT02944929|"     The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections and     usual physiotherapy should increase the proportion of patients who attain their Primary     Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum     Toxin Injections and conventional physiotherapy), in post stroke out-patients with     spasticity.   "
26035|NCT02944916|"     The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each     irrigation   "
26036|NCT02944903|"     The investigators will conduct nationally representative survey in chest physicians in Egypt     in 2016-2017. Self-administered questionnaire will be used to assess the physicians'     knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening     tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or     sputum cytology in the past 12 months.   "
26038|NCT02944877|"     This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using     online social networks to scale peer community leader models to increase HIV prevention     within African-American and Latino men who have sex with men. The peer community leader     model, which teaches community popular opinion leaders about how to disseminate behavior     changes messages throughout the community, has been proven to increase HIV prevention     behaviors. Social networks such as Facebook.com may be a cost-effective platform for scaling     these models. Primarily upper middle-class White populations used the Internet in its early     years, however, Internet use within African-American and Latino households has recently     increased dramatically, especially on online social networks such as Facebook.com. People     using the Internet may be at the highest risk for contracting HIV and are using novel     Internet approaches to find sex partners, such as through online social networks. This is the     first study to examine the effectiveness of the HOPE social media intervention to increase     HIV testing among at-risk groups in the United States.   "
26039|NCT02944864|"     To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a     reasonable regimen for subsequent research.   "
26040|NCT02944851|"     The aim of this work is determine the more successful noninvasive method by comparison of two     noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used     in the detection of patients with blood loss.      The works were completed in 6 months. The study was conducted at the blood donation center.     Vital parameters were measured and recorded before making the voluntary blood     donation.Following Masimo brand portable device fingers SpHb value was measured.Then IVC     diameter of patients in the supine position were measured using ultrasonography. Then he left     to donors return in routine blood donation programme. A unit (470ml) of blood were drawn from     each donor. After the blood donation process measured and recorded the vital signs again.     SpHb was measured noninvasively from finger again. Following these measurements were recorded     again by measuring the diameter of IVC.   "
26041|NCT02944838|"     Senior Change Makers is an intergenerational intervention that compares two, 8-week programs:     (1) an advocacy program wherein senior participants perform audits of their physical activity     environments, identify an advocacy project, and advocate for improvements; and (2) a walking     program designed to increase participant physical activity through education and guided     walks. The investigators expect that the advocacy program will produce greater improvements     in seniors' advocacy skills, confidence, and attitudes at 8 weeks.   "
26042|NCT02944825|"     This study will be a single-institutional randomized, single-blinded prospectively controlled     clinical trial of a single dose of Ciprofloxicin 500mg antibiotic tablet as prophylaxis at     the time of office flexible cystoscopy with ureteral stent removal. The control group will be     no prophylaxis oral antibiotics.   "
26043|NCT02944812|"     This trial intends: 1.To evaluate the concentration of Chidamide in the serum and     cerebral-spinal fluid of PTCL patients at certain time points after taking the medicine, to     evaluate the pharmacokinetics of Chidamide in these patients and its CNS (central nervous     system) distribution.      2. To evaluate the efficiency and safety of Chidamide in PTCL patients.   "
26044|NCT02944799|"     A randomized, double-blind, placebo-controlled trial including 160 consecutive patients who     have been diagnosed with both rheumatoid arthritis (RA) and osteoporosis and have been     treated with alendronate (ALN) for five years or more. Patients will be randomized to     discontinuation or continuation of alendronate. Outcomes are measured using dual energy     absorptiometry (DXA), High Resolution peripheral Quantitative Computer Tomography (HR-pQCT)     and biochemical markers of bone metabolism and inflammation after 6 months, 1 and 2 years.   "
27055|NCT02931604|"     The purpose of this study is to clinically evaluate sinus wash device prototypes in patients     with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient   "
26045|NCT02944786|"     The overall aim of the project is to evaluate the Help Overcoming Pain Early model (which     includes patient education, person-centered health dialogues and pain/stress management),     which is an adolescent-centered school health prevention program when adolescents have     chronic pain. This is an intervention that has the hypothesis to support students to manage     their chronic pain. The primary outcome is self-efficacy. Secondary outcomes are self-rated     health, quality of sleep, pain intensity and school attendance. The project aims to evaluate     the intervention through qualitative and quantitative data collection by students and school     nurses. The project has a hybrid design, which means that outcomes of the intervention and     the evaluation of the implementation are taking place in the same data collection. The     results of this project can be of great importance in the early detection of students with     chronic pain and promote their confidence in their own ability to manage their symptoms.   "
26046|NCT02944773|"     Randomized crossover clinical trial in which is intended to assess the effect of facilitated     tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale     stress (ALPS-neo) be observed before, during and one hour after the weight, and compared with     normal practice, without facilitated tucking device.   "
26047|NCT02944760|"     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney     function and in its most advanced stage is called chronic renal failure. Although     hemodialysis replace some kidney function, patients suffer some alterations characterized by     uremic syndrome typically expressed by: motor neuropathy and/or autonomic neuropathy,     cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thus, the     functional capacity and ability to exercise presents diminished these patients. The aim of     this study is to verify the acute effect of low level laser therapy on the functional     capacity of these individuals.      The research will be developed in the hemodialysis unit of the Santa Clara hospital of Santa     Casa de Misericordia de Porto Alegre and the patients will be evaluated before and     immediately after the application of laser therapy protocol. Before the protocol will be     evaluated pain in the lower limbs, Borg scale, level of physical activity through the     International Physical Activity Questionnaire (IPAQ) and blood collection will be held for     later analysis parameters of biochemical oxidative stress and deoxyribonucleic acid (DNA)     damage.      The laser therapy protocol will be applied in 6 points in quadriceps and 4 points in the     gastrocnemius, bilaterally. After application, will be held the 6-minute walk test, effort     subjective perception by Borg scale, assessment of pain in the lower limbs with visual analog     scale and a new blood sample for further analysis. Patients will be randomized in two groups.     The intervention group (IG), which will be held laser therapy and placebo group (PG), where     the laser therapy will be placebo mode applied. The application will take place with the     Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting     of five diodes 850 nanometers (nm) and power output of 200 milliwatts (mW). It is irradiated     6 points in quadriceps and 4 points in gastrocnemius, bilaterally.   "
26058|NCT02944617|"     This randomized clinical trial studies how well probiotic yogurt supplement works in reducing     diarrhea in patients with kidney cancer that has spread from the primary site to other places     in the body and that are being treated with sunitinib. Studying samples of blood and stool     from patients who eat probiotic yogurt and those who avoid probiotic yogurt may help doctors     plan better treatment.   "
26048|NCT02944747|"     Background (brief):        1. Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn          mortality (28 per 1000 live births). In 2010, prematurity represented ~14% of all births          and directly and indirectly contributed to 45% of all neonatal deaths. Gestational age          (GA) is a key determinant of newborn survival and long-term impairment. Accurate          estimation of GA facilitates timely provision of essential interventions to improve          maternal and newborn outcomes.        2. Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported          information, recommended by the World Health Organization for estimating gestational age          but has issues of recall mainly among poorer, less educated women and women with          irregular menstruation, undiagnosed abortion, and spotting during early pregnancy.          Several studies have noted that about 20-50% of women cannot accurately recall the date          of LMP.        3. Relevance: The goal of this study is to improve maternal and newborn outcomes by          increasing the accuracy of gestational age estimation, using menstrual based dating,          that is vital for providing timely and necessary obstetric and newborn care          interventions. The study will determine the efficacy of three community based          interventions using e-platform targeted to improve the recall and reporting of the date          of last menstrual period in a rural resource poor setting. The innovative e-platform          based interventions, if successful, can provide substantial evidence to scale-up in a          low resource setting where e-Health and m-Health initiatives are proliferating with          active support from all sectors in policy and implementation.      Hypothesis :        1. Implementation of conventional and e-platform based interventions will lead to a 30%          improvement in recall of the date of the LMP in adolescent girls and married women in          rural Bangladesh.        2. Intervention triggered improvement in LMP date recall among pregnant women in rural          Bangladesh will improve the accuracy in GA estimation.      Objectives: The main objectives of the study are to:        1. Determine whether a set of conventional and e-platform based interventions improve          recall of the date of the LMP in adolescent girls and married women in rural Bangladesh.        2. Determine whether intervention triggered improvement in LMP date recall in rural          Bangladesh improves the accuracy in GA estimation or not      Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial     comparing three conventional and e-platform based interventions is proposed to improve recall     of GA with a control arm. The trial will be conducted among adolescent girls and recently     married women (within past two years) with no children or a single child in Mirzapur     sub-district of Bangladesh.The interventions include (i) education and calendar for recording     date of LMP (ii) education and SMS based system for recording dates of LMP and reminders     using mobile phone (normal) (iii) education and smart-phone based application for recording     dates of LMP with an inbuilt reminder system.      Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the recall     of LMP date among enrolled participants in the three different intervention compared to     control arm and (ii) increased accuracy of LMP-based gestational age measurement, as compared     to USG, following the intervention.   "
26049|NCT02944734|"     The purpose of this study is to explore the optimal dose of fixed-dose combination of     candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the     combination therapy compared to each of the monotherapy in patients with essential     hypertension.   "
26050|NCT02944721|"     The aim of the study is to establish the genetic, neurophysiological and psychological     phenotype of the patients presenting a persistent neuropathic pain after surgery of the     breast cancer, by comparing the neuropathic painful patients with the not painful and with     the not neuropathic painful . This will be realized on a transverse cohort     (Seintinellecohort) and confirmed on a forward-looking longitudinal cohort.   "
26051|NCT02944708|"     The purpose of this study is to examine the efficacy of maintenance chemotherapy for the     treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms.     Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy;     arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional     chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will     receive maintenance chemotherapy until disease progression or intolerable toxicities.   "
26052|NCT02944695|"     Both patient and staff safety are of major importance during the procedure of fibreoptic     bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and     accessories used as well as careful monitoring during the procedure.   "
26079|NCT02944344|"     The purpose of this study is to see whether patients with metastatic breast cancer, their     caregivers, and their healthcare providers can improve in shared decision making (SDM) and     preparedness around end of life (EOL) planning through participation in Reimagine's online     Four Conversations™ program. The goal is to close clinical practice gaps and enhance the     quality of care for patients with metastatic breast cancer through increased competence and     performance of healthcare providers and healthcare systems.   "
26053|NCT02944682|"     This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel     distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda).     Following a common protocol, each intervention site will recruit 800 pregnant women (aged     18-34 years, <20 weeks gestation), and will randomly assign half their households to receive     LPG stoves and a 30-month supply of LPG. Controls will receive the same cookstoves and LPG     supply at the end of the study. The mother will be followed along with her child until the     child is 2 years old. The researchers estimate that 25% of households will have a second,     non-pregnant older adult woman (aged 35-64 years) who will also be enrolled at baseline and     followed during the 30-month follow-up period. To optimize intervention use, the researchers     will implement behavior change strategies informed by previous experiences and formative     research in Year 1. This study will assess cookstove use, conduct repeated personal exposure     assessments of household air pollution, and collect dried blood spots and urinary samples for     biomarker analysis and biospecimen storage. The primary outcomes are low birthweight,     pneumonia incidence, and linear growth in the child, and blood pressure in the older adult     woman. Secondary outcomes include preterm birth and gross motor development in the child,     maternal blood pressure during pregnancy, and endothelial function, respiratory impairment,     carcinogenic metabolites, and quality of life in the older adult woman.   "
26054|NCT02944669|"     This study seeks to further evaluate the Multi-Tiered Training Program and to further explore     the overall safety profile of the ReWalk Personal Device outside of the institutional setting     under conditions of routine medical practice.   "
26055|NCT02944656|"     This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2     hours preoperatively in conjunction with perioperative paracervical block for surgical     abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce     perioperative and postoperative pain associated with surgical abortion. Additionally, the     researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and     consumption of pain medication.   "
26056|NCT02944643|"     Chronic liver disease and cirrhosis pose a huge financial burden to the health care system.     This includes the cost of medical care, employment, disability-related issues and reduced     survival. Specifically, the complication of cirrhosis known as hepatic encephalopathy (HE)     especially hinders quality of life, the performance of activities of daily living and the     ability to drive a motor vehicle in affected subjects. The hidden burden to family members     and caregivers of these subjects, however, has been all but ignored to date. Evaluation of     family members and caregivers is essential. The burden of caring for someone with liver     disease can result in added cost for health care for family members and caregivers and is     typically not recognized. The importance of the burden to families and family members or     caregivers resulting from other neurological diseases such as Alzheimer's has been well     evaluated and specific strategies to educate and counsel family members and caregivers have     been elaborated. This is important because as the findings of this study have emerged, we     have found that both Veterans and non-Veterans with cirrhosis and HE have a poor quality of     life, worse socio-economic status and place a significantly higher burden on their family     members or caregivers than those without HE   "
26057|NCT02944630|"     The aim of this study is to determine the benefits of individual psychotherapy on quality of     life for people with psoriasis receiving medical treatment versus a control group (awaiting     group) treated with medical treatment, without psychotherapy.   "
26060|NCT02944591|"     The purpose of this research study is to investigate the potential benefits of participant     use of a smartphone application (App) called COPD Co-Pilot™. When used by the participant,     COPD Co-Pilot™ may provide early detection of worsening COPD symptoms. Early symptom     detection may allow the pulmonary providers and nurses to respond with timely medical advice     and treatment. The goal for use of COPD Co-Pilot™ is to reduce the frequency and duration of     hospitalizations, emergency department visits, and hospital readmissions. The study will also     examine the financial impact of the COPD Co-Pilot™ program to determine whether costs of     hospital stays, emergency department visits, and hospital readmissions differ when patients     are enrolled in COPD Co-Pilot™ than when they are not enrolled. Another purpose of this study     is to measure patient satisfaction with use of COPD Co-Pilot™.   "
26061|NCT02944578|"     The purpose of this study is to see if curcumin can reverse a cervical precancerous state by     looking at people who have the condition and intervening with a study drug or placebo (an     inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP)     which is a treatment procedure for removing cervical cancer. 40 women with high grade     squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000     mg capsule of curcumin or a placebo in their vagina daily for 12 weeks. After a 4 week long     washout period the participants will then undergo removal of the precancerous cells as     recommended standard of care. Participants will have regular monthly visits for the duration     of the study.   "
26062|NCT02944565|"     This phase II trial studies the side effects and how well daratumumab works in treating     patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such     as daratumumab, may interfere with the ability of tumor cells to grow and spread.   "
26063|NCT02944552|"     The test adopted the superiority design of multi center, randomized, double-blind, positive     control drug, dose finding, using two simulation skills. The qualified subjects, according to     the ratio of 1:1:1, were randomized into low dose group and high dose group and positive drug     control group, and received a treatment course of 4-8 weeks, all individuals were followed up     for 4 weeks after drug withdrawal.   "
26064|NCT02944539|"     Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,     including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with     the initiation and development of gastric cancer.The aim of this study was to explore     association between mtDNA content in peripheral blood cells could be used as a risk predictor     for gastric cancer.   "
26080|NCT02944331|"     The aim of this study is to evaluate the long-term effects of endovenous steam ablation     (EVSA). Postoperative data at 3-4 year follow-up will be collected from patients treated with     EVSA.   "
26193|NCT02942849|"     Prospective, non-comparative, multi-centre, multi-country, observational post-authorization     study, to correlate predictive factors with number of oocytes in relation to the gonadotropin     dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and     GnRH-antagonists for pituitary suppression   "
26065|NCT02944526|"     Patients presenting with subacute, less than 6 months of evolution, adhesive capsulitis are     randomly attributed to the control or study group. Both groups receive a series of 3     suprascapular nerve blocks under ultrasound guidance with either 5ml saline or 5ml     ropivacaine 2mg/ml ( ref) at 1 week interval. Testing consists of glenohumeral range of     motion (ROM) (anterior elevation, lateral elevation, external and internal rotation) measured     by goniometer, Constant score and visual analog scale (VAS) pain score. Evaluations are done     immediately before and one hour after every suprascapular block and at 4 weeks after the     third suprascapular block.      All suprascapular nerve blocks are performed by one physician and the evaluations are done by     a occupational therapist or MD experienced in glenohumeral function evaluations. All     practitioners are blinded to the assigned group.      All patients continue their pre-study treatment of physiotherapy and per os pain medication.     Patients keep a record of analgesics and NSAID use during the trial. Drop-out rate is     measured.   "
26066|NCT02944513|"     Research Objectives: This is a 1-year trial designed to gather information about the use of     the Quell for persons with chronic musculoskeletal low back pain. The investigators     hypothesize that those assigned to using the device will report reduced back pain compared     with those in the control condition; with those using the device also showing improvement in     sleep, mood, and level of activity. The investigators hypothesize that frequency of using the     Quell (increased tolerability and adherence) will be correlated with greater reduction in     pain. The investigators hypothesize that the device will be safe to use and will demonstrate     a reduction in healthcare utilization (reduced clinic and ED visits). Finally, based on     preliminary analyses limited by few subject numbers, the investigators will investigate     whether certain individuals report greater benefit from using the Quell than others and, in     particular, would predict that those with more intense and longer duration of pain will     demonstrate most benefit.   "
26067|NCT02944500|"     The purpose of this protocol is to investigate the effect of treatment with the study drug     Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and food     intake.   "
26068|NCT02944487|"     The objectives of this study were to evaluate the safety and tolerability of lucerastat, and     to determine its pharmacokinetic profile as single oral doses at different strengths.   "
26069|NCT02944474|"     The objectives of this study were to evaluate the safety and tolerability of lucerastat and     to determine its pharmacokinetic profile after multiple dosing. Also, the potential effect of     food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.   "
26070|NCT02944461|"     To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the     trunk   "
26071|NCT02944448|"     The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week     Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period     at the optimal dose level determined for each patient, and a 1-week Follow-up Period.      Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio. Every     patient will be started on a 1-mg dose of CR845 or matching placebo. During the     post-randomization Titration-to-Effect period, the dose of study drug may be increased to 2.5     mg or 5 mg in a double-blind fashion. Patients may know their dose is being changed but will     not know whether they were randomization to active study drug or placebo. Approximately 330     patients will be enrolled in this study.   "
26072|NCT02944435|"     This is a Phase 1, randomized, single-dose, 2-way crossover PK comparability study of CB-839     administered as capsule and tablet formulations in healthy adult subjects.   "
26073|NCT02944422|"     This study is designed to determine the prevalence of oral habits among primary Egyptian     school children in Cairo Governorate, Egypt.   "
26335|NCT02940990|"     This protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the     efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver     mutations.   "
26075|NCT02944396|"     This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination     with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or     carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to     veliparib in combination with platinum doublet chemotherapy results will improve progression     free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in     participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2     portion).   "
26076|NCT02944383|"     A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy     Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)   "
26077|NCT02944370|"     The investigator is pilot testing the feasibility and impact of a low-cost intervention that     uses existing gymnasiums, and therefore has the potential to be replicated across the United     States. The intervention, PlayFit, is designed for adults aged 21-50. PlayFit has five key     components, intended to overcome the major barriers to physical activity. First, it will     assist people in finding others to play with, using the Pick-Up model of designating times to     play and making those times known in the community. Second, it will overcome a lack of     confidence in physical activity by including games of lower intensity for relatively unfit     adults, then building up to moderate and vigorous games. Third, it will require team members     of varying ages and genders to encourage intergenerational play. Fourth, it will use modified     equipment (e.g., softer, lighter balls) and smaller game space to require less running, so     that even relatively unfit people can feel confident participating. Fifth, it will be     designed to be led by community volunteers, which will increase its disseminability.      AIM - Understand the optimum design for PlayFit. To meet this aim, the investigators will     come up with a list of games to play and pilot the games at a gymnasium. The investigators     will observe the participants playing the games and have them complete a brief survey.   "
26078|NCT02944357|"     This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and     AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and     who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from     a person's tumor cells may help the body build an effective immune response to kill tumor     cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may make     the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.   "
26081|NCT02944318|"     School is a favorable environment for the development of actions aimed at healthy behavioral     changes. This project proposes to evaluate the effectiveness of an intervention program on     aspects of lifestyle, with a focus on physical activity (PA) and reducing sedentary     behaviors, and the relationship of these factors with the academic performance of students in     the school from Florianopolis, SC, Brazil.      This is a randomized controlled intervention study enroling classes of 7th to 9th grade of     fundamental education.      The intervention program will last for one year (about ten months), with three focuses:     training of teachers, educational and environmental changes to behavior change.   "
26082|NCT02944305|"     Failure in airway management is one of the most common anesthesia-related morbidity and     mortality. Each individual airway assessment has limitation to predict difficult intubation.   "
26083|NCT02944292|"     The purpose of this study is to evaluate the effect of deepening of sedation on     intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal     hypertension.   "
26084|NCT02944279|"     The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with     protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care     unit (ICU) throughout the world. In recent years, much effort has been focused on the     biological markers for their potential values to diagnose ARDS and outcomes.      ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability,     which subsequently caused an influx of neutrophils into the interstitium and alveolar space.     It was reported that the aggregation, adhesion activation and release proteases of     neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the     most crucial protease generated in neutrophil azurophilic granules, plays an important role     in various inflammations, especially the lung injury. The destructive action of HNE on almost     all extracellular matrix influences cell signaling through cleavage of surface receptors.     Once released in circulation, HNE is rapidly inactivated by conjugation with PI3. This local     inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the investigators plan     to conduct a cohort study with repeated measures to examine the diagnostic and prognostic     value of HNE and PI3 for ARDS.   "
26085|NCT02944266|"     This is an observational study to evaluate the role of a Bed side Focus assessed     Transthoracic Echocardiography (FATE) in identifying the patients at a potential risk of     developing hypotension secondary to general anesthesia induction using the FATE parameters     like velocity time integral ( VTI ), Inferior venacava diameter , Caval index and Left     ventricular end end diastolic area.   "
26098|NCT02944084|"     The oral absorption and urinary excretion kinetics of the bioactive ingredients from rice     bran (gamma-oryzanol, tocotrienols, tocopherols and ferulic acid esters) after incorporation     into an oat porridge (oat porridge) compared to unprocessed rice bran extract oil were     investigated. The influence of the type of preparation (with water vs. milk) of porridge on     the bioavailability of the bioactive compounds was compared. The study followed a single dose     (2 g rice bran extract), randomized, three armed crossover study design with ≥1-week washout     periods. Plasma and urine samples were collected at intervals up to 24 h after intake.   "
26086|NCT02944253|"     Two dietary approaches, very low energy diets (VLEDs) and ketogenic low carbohydrate diets     (KLCDs), have the ability to suppress appetite. The suppression of appetite typically     observed during these diets is believed (but not clinically proven) to be due to ketosis, a     condition where circulating concentrations of ketone bodies are increased due to a higher     production of ketones in the liver. Little is known about the potential mechanisms through     which ketosis may lead to appetite suppression in VLEDs and KLCDs. A 'ketogenic diet'     typically contains less than 50 grams carbohydrate per day, yet ketosis has been seen in     subjects who consume diets with a carbohydrates ranging between 59-192 grams per day.     Although an association between ketosis and appetite suppression has been established, the     minimum level of ketosis and maximum carbohydrate intake that is still associated with     appetite suppression remains unknown and should be explored. The ability to increase     carbohydrate intake while maintaining a suppressed appetite will allow dieters to consume     more carbohydrate-rich food that is beneficial for health without feeling more hungry. The     aim of this study is, therefore, to identify the maximum carbohydrate intake that is still     associated with appetite suppression in a low energy diet and to determine the impact of a     higher carbohydrate intake on appetite suppression, body composition, and resting metabolic     rate.   "
26087|NCT02944227|"     The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly     dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in     neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor)     monotherapy.   "
26088|NCT02944214|"     The purpose of this study is to determine whether febuxostat and benzbromarone could protect     renal function in chinese, and which one could be better.   "
26089|NCT02944201|"     This will be a single arm, window of opportunity study in men with treatment-naïve prostate     cancer who will proceed to prostatectomy. Men will be treated with carvedilol prior to     undergoing prostatectomy.   "
26090|NCT02944188|"     In this study, the investigators have compared the clinical outcomes of the laparoscopic and     open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the     treatment of right-sided colon cancer.   "
26091|NCT02944175|"     Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse     neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and     have adverse effects associated with stimulation of muscarinic receptors. In addition,     neostigmine cannot be used to reverse profound blockade.      Anesthetics may exert their effects on various facets of cerebral function such as cerebral     metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling,     intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical     activity. The net result of all these effects of the anaesthetic agents combined with their     systemic effects may prove beneficial or detrimental to an already diseased brain.      In neurosurgical patients, clear and rapid recovery is required to early assess the     neurological status and to maintain the cerebral oxygenation and metabolism within the normal     physiological values which may be saved by sugammadex.   "
27424|NCT02926781|"     Radiographic evaluation of the amount of bone height gain and clinical evaluation of the     possibility of developing complications after transcrestal sinus floor elevation using drills     and the conventional osteotome technique.   "
26093|NCT02944149|"     The study is a non-inferiority randomized controlled trial (RCT) that aims to demonstrate     that tubal ligations by minilaparotomy (ML) conducted by trained clinical officers (COs) are     no less safe as compared to those conducted by assistant medical officers (AMOs) in Tanzania.     Participants will be randomized in a one to one ratio to ML by a CO and ML by an AMO. In     addition to the screening and enrollment/ML visit, there will be three scheduled follow-up     visits at 3, 7 and 42 days post-surgery.   "
26094|NCT02944136|"     The proposed randomized controlled trial will test the efficacy of a stepped collaborative     care intervention, versus enhanced usual care arm, to reduce depression of cancer caregivers.     Biobehavioral factors will include assessment of changes in health behaviors and biomarkers     of inflammation. The investigators will also include measures metabolic abnormalities and     clinical markers of CVD. The investigators expect few cardiac events during the study period.     The investigators will also measure other health outcomes but CVD risk factors will be the     focus of the study.   "
26095|NCT02944123|"     East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or     ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these     regimens are more adequate for clinical practice in Korea is unclear. Therefore, the     investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors     in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary     intervention (PCI).   "
26096|NCT02944110|"     Patients with diabetes are characterised not only by compromised insulin secretion and     action, but also by elevated plasma levels of the 29-amino acid peptide hormone glucagon,     which hitherto has been considered a pancreas-derived hormone (produced in and secreted from     alpha cells in the islets of Langerhans). In patients with diabetes, circulating glucagon     concentrations are elevated in the fasting state and fail to decrease appropriately or even     increase in response to an oral glucose tolerance test (OGTT) or after ingestion of a mixed     meal. Hyperglucagonaemia is known to be a potent stimulator of hepatic glucose output, and,     thus, contributes significantly to the fasting and postprandial hyperglycaemia characterising     patients with diabetes. Despite intense research over the years the mechanisms behind the     elevated glucagon levels in diabetes is still not clear. Recently, the investigators showed     that totally pancreatectomised patients also show a hyperglucagonaemic response during OGTT,     a finding that suggests that the pancreas is not the only source of glucagon production in     man.      In the present project, the investigators wish to evaluate the impact of gastrointestinally     derived glucagon secretion observed in totally pancreatectomised patients on postprandial     glucose tolerance.      The investigators hypothesise that antagonisation of glucagon signalling (from     gastrointestinally derived glucagon) in totally pancreatectomised patients will improve or     perhaps normalise the patients glucose tolerance during a 75g-OGTT. In order to test this     hypothesis, the investigators wish to apply the potent and selective oral antagonist of the     human glucagon receptor LY2409021 and placebo, respectively.      The study is a randomised, placebo-controlled, double-blinded, cross-over study.      10 healthy persons and 10 pancreatectomized patients (i.e. patients who have had their     pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected     to two experimental days with LY2409021 and placebo, respectively, on which they will undergo     an OGTT followed by a fasting period and finished off with an ad libitum meal.   "
26097|NCT02944097|"     To enhance the oral bioavailability of the antioxidants trans-resveratrol and     trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was     incorporated into micelles. A single dose, single blind, two arms crossover trial was     conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake     of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and     compared between formulations. Tolerability of the dose was also controlled by safety     parameters in plasma.   "
26099|NCT02944071|"     This clinical study is a prospective, non-randomized, multicenter study to demonstrate the     acceptable safety and performance of angioplasty with the Ranger DCB in native     femoropopliteal artery lesions. It is intended that all patients with qualifying lesions     would be considered for enrollment and treated with the Ranger DCB catheter. Approximately     123 patients with femoropopliteal artery lesions will be enrolled. All lesions will be     treated with the Ranger DCB. Up to 15 clinical sites located in China are expected to     participate.   "
26100|NCT02944058|"     The purpose of the project is to compare the management of 3 and 4 part proximal humerus     fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail     (Multiloc) in light of complications, radiological, economical, functional and clinical     outcome.   "
26101|NCT02944045|"     Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients.     Mortality remains high for those patients with comorbidities (50% for patients with the most     severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in     non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with     PcP has been associated with decreased mortality but in non-HIV patients, adjunctive steroids     remains controversy. Some retrospective studies in that field did not find any beneficial     effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the studies     were retrospective, non randomised studies including various underlying disease and severity     of PcP was variable. Moreover, dosage and delay of steroids were variable leading difficult     to interpret all the results.      The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV     immunocompromised patients with a double blinded randomised clinical trials comparing     adjunctive steroids to placebo.   "
26102|NCT02944032|"     Th main objective of the study is to assess the efficacy of a home-based, computerized     cognitive training (CT) program, called CogmedRM, targeted to improve working memory in     children with NF1 and working memory difficulties.This is a Phase II randomized parallel     group controlled clinical trial comparing two interventions on cognitive outcomes.     Participants will be stratified by stimulant medication use and randomized equally between     the two interventions within stratum. Participants will be in the study for to 11 weeks.   "
26103|NCT02944019|"     In order to understand the risks and benefits of edoxaban use in a real-world clinical     setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed     this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver     adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in     patients with NVAF who were not preselected.   "
26104|NCT02944006|"     This study aims to establish radiomics database for pancreas cancer from multiparametric MRI     including DCE-MRI obtained by using incoherent undersampling and radial acquisition for     clinical staging as well as quantitative analysis.   "
26194|NCT02942836|"     The goal of the proposed study is to test the capability of the CareTaker monitor to extract     the respiration signature from its acquired signal, and to determine a respiration rate of     breaths/minute that meets or exceeds the performance levels of its predicate device.   "
26195|NCT02942823|"     Obesity and its associated comorbidities are becoming a key and rapidly growing public health     problem. The cause of obesity is an imbalance between energy intake and energy expenditure in     favor of the former. Childhood and adolescence are seen as critical time for its development.     It is therefore crucial to provide both prevention and treatment actions already during     childhood. The prevention and treatment weight-management programs in children focus on     improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One     important basic requirement for any weight-management program is, that both children and     their families are motivated and ready for change. Video games, including exergames, serious     games or combined approaches offer additional chances in the treatment and prevention of     obesity by approaching children in their environment and motivating them to deal with     life-style topics.      As children do not decide alone what they eat - but their parents - the involvement of     parents in the intervention appears to be very important to reach a sustained effect.      The investigators developed a motion-controlled serious game for children aged between 9 and     12 years, addressing all the three core areas nutrition, physical activity, and psychosocial     factors. In addition to the motion control, a tablet is used for knowledge-based and     cognitive tasks. In comparison to other studies the nutrition part not only deals with the     food pyramid but also with the energy density of foods and liquids and offers a     self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects,     especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises and     a reflexion exercise about leisure behaviour. The game consists of two sessions, having each     a duration of about 35 minutes.      The aim of the KOP-1 study was to evaluate the game regarding its acceptance and efficacy in     a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12     years. The aim of the here presented KOP-2 study is to evaluate the game regarding its     acceptance and efficacy in a randomized controlled trial in parents of primary school     children aged 9 to 12 years receiving the KOP-1 intervention. Therefore, 4th grade pupils of     the same school will be randomly allocated to an intervention and a control group. Both     groups will play the game within two weeks, whereas the intervention group will take the game     home on a tablet computer to play it with their parents in between session 1 and 2. At     baseline, one day after session 2 and at four weeks follow-up, measurements will be performed     in pupils and the parents of the intervention group. The primary outcomes of the study are     the gain of knowledge (nutrition, psychosocial aspects) in parents and children, measured by     a self-constructed questionnaires tailored specifically for the serious game. Secondary     outcomes are the interaction of pupils and their parents for the intervention group,     acceptance of the game, changes of nutrition behaviour, physical activity and intentions of     the children to follow a healthy lifestyle, measured by mostly validated questionnaires.   "
26105|NCT02943993|"     According to current guidelines, duration of anticoagulant treatment after a venous     thromboembolic event varies from 3 months to indefinite treatment depending on the estimated     risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are     limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013;     369:1406-15).      Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic     recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality     and other drug related adverse events) of extended treatment with edoxaban up to 18 months in     an unselected patient population in routine clinical practice.   "
26106|NCT02943980|"     A randomized controlled prospective study of laryngoscopy and evaluation of the     Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the     McGrath® Mac videolaryngoscope.   "
26107|NCT02943967|"     The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and     photorefractive keratectomy for refractive correction in patients with bilateral asymmetric     topography.   "
26108|NCT02943954|"     Although current guidelines recommend fractional flow reserve (FFR) to identify     haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is     not available (Class I, Level of Evidence: A), no published study has assessed the usefulness     of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial     infarction (STEMI) patients with multi-vessel disease (MVD).      The main objective of this study is to determine whether, in STEMI patients with MVD amenable     to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes,     compared with the current practice of angiography- guided PCI, by improving the     appropriateness of revascularisations by assessing the relevance of non-culprit lesions in     the context of STEMI with multivessel coronary artery disease.      The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided     strategy compared to the angiography-guided strategy.   "
26109|NCT02943941|"     The purpose of this study is to understand how the pressure in the pulmonary artery changes     under different conditions of posture, respiration and exertion.   "
26110|NCT02943928|"     laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning   "
26111|NCT02943915|"     A randomized, controlled trial comparing exoskeleton gait training with standard gait     training or no gait training in community-dwelling participants with chronic incomplete     spinal cord injury   "
26112|NCT02943902|"     This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal     Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at     either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule),     and compare this immune response to those who receive a two dose primary series (at 6 and 14     weeks of age) and booster dose at 9-months (2+1 schedule).   "
26113|NCT02943889|"     Chronic liver disease end by liver cirrhosis and increases the risk of cancer development.     Chronic liver disease in Egypt is recognized as a serious health problem affecting greater     than (20 %) of the population, where the main cause is chronic infection.      Liver transplantation is still the standard treatment for advanced decompensated liver     cirrhosis. However, this treatment is quite limited in clinical practice. Therefore there is     a concerted effort around the world to develop regenerative and alternative therapies, so,     stem cell-based therapies are emerging as new alternatives to liver transplantation for     end-stage liver pathologies.   "
26114|NCT02943876|"     Major depressive episode (MDE) is one of the most prevalent and disabling form of mental     illness in the general population. Despite increased mental health services and     antidepressants use in the past 10 years, there has been no measurable change in the     prevalence of MDE in the Canadian general population, which motivates the search for     additional strategies for reducing the burden of MDE. One strategy that has been successful     in the fields of oncology, cardiology and diabetes is early identification and prevention -     identifying people who are at high risk and taking preventive actions to lower the risk so as     to prevent symptoms from progressing into a MDE. As multivariable risk prediction algorithms     are used to estimate an individual's risk (probability) of future disease, they can play an     important role in the process of early identification. The proposed study stems from a     project funded by an operating grant from the Canadian Institutes of Health Research (CIHR).     With the CIHR support, the team developed and validated sex-specific prediction algorithms     for MDE. As risk prediction is at very early stage in psychiatry and MDE is still highly     stigmatized, to facilitate the future implementation of the developed risk prediction     algorithms, the proposed study seeks to answer the following research questions: (1) Does     disclosure of personalized depression risk information promote high-risk individuals to take     preventive actions? (2) Will disclosure of personalized depression risk information     negatively affect high-risk people's mental health status in terms of increased psychological     distress? To answer the questions, the investigators planned to conduct a randomized     controlled trial (RCT) with an embedded qualitative component. The proposed study will     develop an evidence base for guiding the disclosure of personalized risk information and     understanding the process of risk communication and consumer empowerment, contributing to the     advancement of early prevention of MDE in Canada.   "
26115|NCT02943863|"     High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced     for bedside care. It has been shown to be associated with reduced risks of tracheal     intubation rates and mortality in adult hypoxic patients.      The mechanisms of the effects of HFNC are thought to be related to the favorable effects of     the heated and humidified gas, the high-flow rate used to minimize the entrainment of room     air, and an increase in the ventilation efficiency, including the elimination of     nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements     in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation     in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However,     how regional ventilation is affected during HFNC in comparison with conventional NC remains     unknown.      Because PEEP in mechanically ventilated patients improves the regional homogeneity of     ventilation, investigators postulated that HFNC via PEEP effects would result in more     homogeneous regional distributions in the ventilation changes. Investigators therefore     assessed global and regional ventilation in patients with hypoxia receiving care via HFNC     using electric impedance tomography and compared these results with conventional nasal     cannula.   "
26177|NCT02943057|"     25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either     uveitis or endotheliitis, will be started on 2% guttae ganciclovir, 1 drop 5 times a day for     6 weeks.      Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be     reviewed at the clinic within 3 hours following the last application of topical ganciclovir     and clinical features will be documented for activity assessment. An aqueous sample 0.2ml is     drawn. 0.1ml will be sent for RT-PCR for CMV viral load and another 0.1ml will be sent for     ganciclovir drug level by HPLC method.   "
26116|NCT02943850|"     The investigator is examining the safety of transplanting cells that have been engineered to     produce a growth factor into the spinal cord of patients with Amyotrophic Lateral Sclerosis     (ALS). The cells are called neural progenitor cells, which are a type of stem cell that can     become several different types of cells in the nervous system. These cells have been derived     to specifically become astrocytes, which is a type of neuronal cell. The growth factor is     called glial cell line-derived neurotrophic factor, or GDNF. GDNF is a protein that promotes     the survival of many types of neuronal cells. Therefore, the cells are called     CNS10-NPC-GDNF. The investigational treatment has been tested in animals, but it has not     yet been tested in people. In this study, we want to learn if CNS10-NPC-GDNF cells are safe     to transplant into the spinal cords of people.   "
26117|NCT02943837|"     Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve     clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently     considered the standard method for sampling SET, its diagnostic yield is generally     suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate     histology obtained.      Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.   "
26118|NCT02943824|"     The proposed, mono-institutional, randomized-controlled trial aims to determine whether the     dosimetric outcomes following prostate Low-Dose-Rate (LDR) brachytherapy, planned using a     novel machine learning (ML-LDR) algorithm, are equivalent to manual treatment planning     techniques. Forty-two patients with low-to-intermediate-risk prostate cancer will be planned     using ML-LDR and expert manual treatment planning over the course of the 12-month study.     Expert radiation oncology (RO) physicians will then evaluate and modify blinded, randomized     plans prior to implantation in patients. Planning time, pre-operative dosimetry, and plan     modifications will be assessed before treatment, and post-operative dosimetry will be     evaluated 1-month following the implant, respectively.   "
26119|NCT02943811|"     The investigators sought to retrospectively assess whether the use of a intrauterine device     to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by     laparoscopy for endometrial cancer   "
26120|NCT02943798|"     The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus     carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced     pulmonary large cell neuroendocrine carcinoma.   "
26121|NCT02943785|"     When the upper chambers of a person's heart receive irregular electrical signals it causes     abnormal rhythm in the heart beat. This is called atrial fibrillation.      Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients     also get new heart valves using a catheter.      Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is     considered the standard care. This study will see how edoxaban compares to VKA in patients     who got a new heart valve by using a catheter.      The study will compare the two drugs for up to three years after heart valve replacement,     looking at the drug's overall side effects (called adverse events) and major bleeding.   "
26122|NCT02943772|"     The investigators propose to examine the effect of local cooling of testis in participants     with acute epididymitis or orchiepididymitis on participants reported pain level and     analgetics consumption.   "
26123|NCT02943759|"     The trial is to test the resolution of pain, swelling and other signs of periapical infection     and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as     root canal irrigant in Pulpectomy treatment for children.   "
26139|NCT02943551|"     Unwarranted use of antibiotics for pediatric acute respiratory tract infections (ARTIs) and     use of second-line, broad spectrum antibiotics for bacterial ARTIs has contributed to the     rapid development of resistance in many strains of bacteria. Provider-parent communication     during pediatric visits for ARTIs strongly influence antibiotic prescribing rates. The     overall goal of this study is to develop and test a distance learning quality improvement     (QI) program called Dialogue Around Respiratory Illness Treatment - DART. The DART program     aims to improve provider communication practices and treatment decisions during pediatric     ARTI visits, with the ultimate goal being to decrease rates of antibiotic prescribing for     these illnesses in children.   "
26124|NCT02943746|"     While new innovations in the care of extremely premature infants have led to decreased     morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in     the postnatal period influences neurodevelopmental and growth outcomes.      This proposed study will challenge current nutritional regimens for infants < 1000 g birth     weight (BW) by providing an exclusive human milk based diet with a higher amount of protein     based on individual caloric and protein analysis of human milk utilizing targeted     fortification. The investigators will evaluate the effects of a high versus standard protein     enteral diet on growth and body composition in infants < 1000 g BW.      There are no published studies evaluating the effect of an exclusive human milk protein diet     on body composition in premature infants. Research has shown that infants who receive this     diet achieve growth at targeted standards but body composition has not been evaluated. As an     all human milk diet is well tolerated and associated with improved outcomes in the highest     risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human     milk diet and the possible positive changes in body composition, specifically lean mass, in     these infants.      Results from this proposed study will immediately influence current nutritional practices and     will provide landmark information regarding targeted fortification with provision of adequate     protein providing the most optimal body composition in the most fragile and vulnerable     infants.   "
26125|NCT02943733|"     The goal of this study is to establish maximum tolerated doses/recommended phase 2 dose     (RP2D) of temozolomide (TMZ) and TAS-102 when these agents are used in combination and to     evaluate the safety profile of this drug combination.   "
26126|NCT02943720|"     A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and     Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping     Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic     Rhinitis/Rhinoconjunctivitis   "
26127|NCT02943707|"     This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi)     therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while     control group will only receive drugs therapy.   "
26128|NCT02943694|"     Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total     mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer     patients have been considerably improved. However, anatomical limitations in pelvic space     hinder the further optimization of surgical treatment Thus, the natural orifice transluminal     endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal     total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception     and single port technique, has been prevailing both in West and East nations, with or without     the abdominal laparoscopic assistance. Up to date, there are various kinds of instruments and     patterns to complete TaTME with comparable clinical outcomes. However, flaws in each     instrument remains according to the feedbacks. This study is therefore designed to clinically     evaluate the feasibility and safety of the new instruments specifically for TaTME     (CS-Compact, GelPoint pathway).   "
26129|NCT02943681|"     This study evaluates the non-specific effects on child mortality and morbidity of a second     dose of measles in the second year of life. Half of the study participants will receive a     second dose of measles vaccine at 18 months of age while the other half will receive a second     dose of measles by 4 years of age or at the end of the study.   "
26130|NCT02943668|"     This phase II trial studies how well deferasirox works in treating patients with very low,     low, or intermediate-risk anemia or myelodysplastic syndrome that depends on red blood cell     transfusions. Deferasirox may treat too much iron in the blood caused by blood transfusions.   "
26131|NCT02943655|"     Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow,     frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual     abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml     or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic     disease.   "
26132|NCT02943642|"     This study evaluates the effectiveness — as judged by complete response — of a single     four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza     (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient     eligibility is stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid     disease or a prior bone marrow / HSCT transplant.   "
26133|NCT02943629|"     The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a     P Blade (Figure 1) as the means to provide Apneic Oxygenation (AO) and prolong Duration of     Apnea Without Desaturation (DAWD) in non-obese and morbidly obese females.   "
26134|NCT02943616|"     The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center,     single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world     setting following commercial physician training'and to observe the effectiveness of     commercial physician training on appropriate vessel sizing.   "
26135|NCT02943603|"     This research study is being down to find what, effects, good and/or bad, adding     Pembrolizumab to standard chemotherapy mFOLFOX before and after surgery have on the patient     and the patient's cancer.   "
26136|NCT02943590|"     This research study will test whether atorvastatin, a drug commonly prescribed for reducing     cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin     is from a family of medications that are commonly called statins   "
26137|NCT02943577|"     This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams     (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major     depressive disorder (MDD) who have a partial response to ADT.   "
26138|NCT02943564|"     This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel,     225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy     (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.   "
26140|NCT02943538|"     Pragmatic clinical trial, randomized, controlled parallel, 3 group (group technology     platform, call group and control group), developed in the monograph Reference Unit of     Inflammatory Bowel Disease Valencia (single-center).   "
49723|NCT02634788|"     The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine     Sublingual (under the tongue) Spray compared with placebo in participants with postoperative     pain after bunionectomy.   "
26141|NCT02943525|"     Vaginal packing is used routinely following vaginal reconstructive surgery, however, no     recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite     little data to support the practice, purported benefits better positioning and fixation of     the mesh, improving incorporation of the mesh by its fixation and reduced blood loss.     Patients often complain of discomfort associated with the packing or its removal. The aim of     this randomized controlled is to compare the subjective impressions of pain and bother in     women undergoing laparoscopic sacrocolpopexy treated with and without packing. The     investigators also aim to assess differences in postoperative bacteriuria, urine retention     and hemoglobin levels on day 5 after the surgery and surgery outcome and complications at one     year after the surgery in those with and without packing.   "
26142|NCT02943512|"     This study is to assess if subjects receiving a clinically indicated implanted cardiac     pacemaker or defibrillator can be safely discharge home the same day of the procedure.   "
26143|NCT02943499|"     The purpose of this study is to understand brain mechanisms of app-based mindfulness training     in smokers ages 21 to 65 years.   "
26144|NCT02943486|"     The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal     cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2)     in adults. A third of the participants will receive dac-MSCs and Triticum vulgare     (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and     the last third only Fitosimoline. This study will be a randomized, blind, and parallel and     controlled-group trial.   "
26189|NCT02942901|"     Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal     cancer and promising overall survival was observed in retrospective studies with selected     patients. This study investigated whether the preoperative FDG- PET/CT scan influences     survival in this patient group. Furthermore, we tried to identify other prognostic factors     associated with overall survival and progression-free survival.   "
26145|NCT02943473|"     The purpose of this research study is to test whether the drug ibrutinib (trademark name:     IMBRUVICA®) is effective at preventing the development of multiple myeloma in people who     currently have smoldering myeloma. The researchers conducting this trial) have reason to     believe that ibrutinib can delay the development of multiple myeloma, thus giving people who     currently have smoldering myeloma a longer period of time when they feel healthy and well.      Smoldering myeloma is an abnormal condition that is considered to be an early phase of the     disease multiple myeloma. In this disorder, there is an abnormal growth of plasma cells,     which is a type of blood cell found in the bone marrow. This growth is not as severe in     people with smoldering myeloma as it is in multiple myeloma, so people with smoldering     myeloma do not have any symptoms and tend to feel well. However, they have a higher risk of     developing multiple myeloma than people in the general population.      Some people with smoldering myeloma are at an especially high risk of developing myeloma -     50% of these people will develop multiple myeloma 2 years after they are diagnosed with     smoldering myeloma. The investigators identify these people by looking at the amount of     myeloma in the bone marrow (called bone marrow plasma cell percentage) and the amount of     myeloma protein (called serum protein electrophoresis and serum free light chain assay)     in the blood. To be considered high risk, individuals must have highly abnormal levels for     these tests.      Based upon current guidelines, people with smoldering myeloma do not require any treatment.     However, known is that many of these people will develop multiple myeloma in the near future.     Currently there have been no proven and effective way of preventing these people from     developing multiple myeloma, which remains an incurable disease.   "
26148|NCT02943434|"     This study will examine differences in diet-induced thermogenesis (DIT) between a meal made     of processed ingredients and an equivalent, isocaloric meal made of whole ingredients. For     the purpose of this study processed foods (PFs) will be considered those that are purchased     in a state that is modified from their whole food (WF) counterpart (e.g. shell eggs compared     to powdered eggs). Research has shown that less energy is expended to digest processed foods     than whole foods, which confers an advantage to processed foods in terms of caloric     efficiency, but a disadvantage in terms of energy balance and weight loss. A 2010 study     showed that subjects expended approximately 10% less energy to digest sandwiches made of     white bread and cheese product compared to sandwiches made of whole grain bread and cheddar     cheese. The intent of this study is to enhance those results and improve upon the study     design by constructing meals to be more similar in the makeup of individual ingredients,     making ingredient processing a more isolated variable. Subjects will be healthy CWU male     students with a body mass index of 18.5 - 24.9 kg/m2. Metabolism will be assessed by repeated     measurements of resting energy expenditure via indirect calorimetry. Measurements of baseline     metabolism will be made; subjects will then be provided one of two meals, both comprised of     rice, green beans, and eggs cooked in canola oil and equivalent but differing in processing     status (e.g. brown rice and white rice, fresh cooked green beans and canned green beans,     etc). Hourly metabolic measurements will be made post-meal for 6 hours. During this time     subjects will be asked to minimize non-DIT deviations in metabolism; e.g. those due to     physical activity, excitement level, etc. The procedure will be repeated one week later with     the other meal so that changes in DIT can be assessed on a subject-by-subject basis. The     results of this study will be assessed in the lens of weight loss, specifically dietary     choices that affect energy balance. It is possible that consuming a diet that includes more     whole foods (versus processed foods) would be beneficial to the attainment of a healthy body     weight - either through potential weight loss or weight maintenance.   "
26149|NCT02943421|"     Placenta accreta is considered a severe pregnancy complication that may be associated with     massive and potentially life-threatening intrapartum and postpartum hemorrhage.     Life-threatening bleeding is the most common complication to be associated with this     condition; the average blood loss at time of delivery is reported to be 3000-5500 mL, which     leads to significant postoperative morbidity and death.   "
26150|NCT02943408|"     Recent Veterans of the OIF/OEF/OND conflicts are presenting in VA care with high rates of:     PTSD, depression, anxiety, and alcohol abuse, reporting significant difficulties with     community reintegration, and dropping out of mental health care at high rates. Surveys of     recent Veterans show that Veterans want the VA to provide mental health care tailored to     their concerns and reintegration priorities. The VA is committed to providing personalized,     proactive, patient centered care (PCC); but little research or intervention development has     been done on PCC in mental health care settings and preliminary research indicates Veterans     may lack the skills and knowledge to be active partners in PCC. This study aims to examine     PCC behaviors in VA mental health care and, informed by this data, develop a brief patient     centered mental health intervention that will help recent Veterans take the lead in their     care personalization and support their functional recovery. Results from this study will     demonstrate the acceptability, feasibility, and preliminary efficacy of this intervention.   "
26151|NCT02943395|"     Light curing cements used for laminate veneers may be not totally cured in certain areas, so     dual cured resin cements may solve this problem yet the dual cured cements containing amines     cause yellowish discoloration of the veneers after time.      A new dual cured cement which is amine free is introduced so the investigators have to try it     clinically using parallel groups in randomized clinical trial.   "
26152|NCT02943382|"     Dry eye disease remains one of the most common complaints seen in ophthalmic clinics. Causes     of dry eye are multifactorial, with the most common cause of evaporative dry eye disease     being meibomian gland dysfunction (MGD).      Fingerprick autologous blood (FAB) is a novel method which uses a patient's own blood to     treat dry eye conditions.   "
26336|NCT02940977|"     1. To elucidate the role of CTC detection in the evaluation of risk level in PCa patients,          and establish a mathematic model for predicting the pathological status.        2. To explore the possible subtle change in CTC condition after radical prostatectomy.   "
26153|NCT02943369|"     Platelets and thrombus formation play a key role in the pathogenesis of acute coronary artery     occlusion and subsequent myocardial infarction. Apart from mechanically opening the occluded     artery with angioplasty, adjunctive antiplatelet treatment is of utmost importance. However,     orally administered antiplatelet agents exhibit a delay in their onset of action in the     setting of acute myocardial infarction and angioplasty is mostly performed without adequate     platelet inhibition. Cangrelor is an intravenous antiplatelet agent which can provide almost     immediate strong platelet inhibition. The investigators aim to compare a strategy of     cangrelor administered on top of ticagrelor-an oral antiplatelet agent- vs ticagrelor alone,     on their efficacy to inhibit platelet function in the early hours of an acute myocardial     infarction.   "
26154|NCT02943356|"     Observational study to evaluate the effect of Tadalafil 5mg once daily on Erectile     Dysfunction and QOL in Andropause patients with Erectile Dysfunction.      Patients will be observed for 8weeks.   "
26165|NCT02943213|"     Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine     Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to     the RLD.      The aim of this pilot study is to investigate intrasubject variability in the bioavailability     of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.      Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve     and a wide safety margin. This will then allow for the modification of bioequivalence     acceptance criteria in future pivotal studies which will reduce the number of participants     required whilst still maintaining assurance of safety and efficacy.      Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A     Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine;     7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%   "
26155|NCT02943343|"     The China Pulmonary Thromboembolism Registry Study (CURES) is a prospective multicenter     registry project initiated in January 2008 and consisting in obtaining an extensive data     registry of consecutive patients with pulmonary thromboembolism.        -  The main objective of this registry study is to help physicians to improve their          knowledge on the natural history of pulmonary thromboembolism, including epidemiological          characteristics, personal history, risk factors, clinical manifestations, diagnostic          methods, therapeutic regimens, clinical outcomes, prognosis, etc..        -  Secondly, this study is also aimed to find some useful information for some patients who          are usually not recruited in randomized clinical trials (pregnant women, elderly          patients, disseminated cancer, severe renal insufficiency, patients with          contraindications to anticoagulation therapy, extreme body weight, etc).        -  Thirdly, the ultimate purpose of CURES study is decreasing mortality, frequency of          thromboembolic recurrences as well as bleeding complications and arterial events.   "
26156|NCT02943330|"     Depression is one of the most common psychiatric diseases, with prevalence estimates ranging     from 5% to 20%. Depression is now recognized as a brain disease; it can be managed and     treated effectively with a wide range of options, but its biological basis is still far from     clear. Studies of monozygotic and dizygotic twin pairs suggest polygenic inheritance, with an     overall heritability estimate between 40% and 70 %. Gene-environment interaction has been     recognized for a long time in the pathophysiology of depression, and its best biological     substratum at present is represented by the serotonin transporter (5-HTT) gene. It would be     interesting to study association between the novel allelic variants or at least the     triallelic 5-HTTLPR polymorphism and depression. Depression is common in patients with     end-stage renal disease and to occur in about 20% to 30% of hemodialysis patients.     Interferon-induced depression is estimated up to 50% among patients with hepatitis C. Several     sets of observations support the supposition that cytokines, and proinflammatory cytokines in     particular, are involved in depressive disorders. Depression sufferers have been reported to     have elevated blood levels of interleukin 1 (IL-1), IL-6 and tumor necrosis factor α (TNF-α).   "
26157|NCT02943317|"     This is a Phase 1/1b, open-label, multicenter, dose-escalation and dose expansion trial to     evaluate the safety, efficacy, PK and PD of defactinib (VS-6063) in combination with avelumab     in epithelial ovarian cancer.   "
26158|NCT02943304|"     This prospective cohort study will determine the natural history of fetal exposure to Zika     virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment     outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV     (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according     to trimester of infection and as exposed and unexposed to ZIKV.   "
26159|NCT02943291|"     The primary aim of this trial is to investigate adipose tissue function in women with and     without polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder in young women.     The pathogenesis behind PCOS is complex and only partly understood, and deeper mechanistic     insight is needed. Insulin resistance is a central feature of PCOS, and recent studies have     suggested that this is linked to aberrant adipose tissue function. Exercise training has been     found to improve the symptoms in PCOS, but we need more knowledge about why. While processes     involved in skeletal muscle oxidative remodeling are well described, it is to a large extent     unknown whether the oxidative capacity of human adipose tissue is modified by endurance     training. The women included in this study will be matched (for body mass index, body weight,     and age) to participants in another study. This will enable the investigators to do a     comparison between cases (women with PCOS) and controls (women without PCOS) at baseline, and     to assess the responses to exercise training in adipose tissue.   "
26160|NCT02943278|"     In this study we are testing 2 different forms of sleep therapy to help people with insomnia     and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to     see how these sleep therapies help insomnia in people with depression.   "
26161|NCT02943265|"     Nearly 70% of people living with cancer are complex patients with multiple chronic     conditions who must deal not only with effects of their cancer but also continuing diseases     such as diabetes, depression, hypertension, or heart disease. Care coordination strategies     shown to be effective in improving outcomes for common medical conditions seen in primary     care include: systematic transitions for patients to and from specialty care; intensive case     management; and a team-based approach to comprehensive care. Despite an Institute of Medicine     report suggesting these strategies as potential ways to improve care for cancer survivors,     their implementation has not yet been evaluated for cancer survivors. Parkland Health and     Hospital Systems will be implementing care coordinator strategies as part of as quality     assurance/quality improvement activities, which Aim 2 and Aim 3 (research components) will     evaluate. This protocol has been organized to reflect this distinction between the aims. The     investigators expect no more than 1500 patients to be included in these study aims.   "
26162|NCT02943252|"     This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial     evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced     (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.   "
26163|NCT02943239|"     Assess the safety and tolerability of REGN2477 alone and combined with REGN1033 in health     postmenopausal women.   "
26164|NCT02943226|"     The purpose of this research study is to compare two types of catheters used for infusing the     contrast dye necessary for viewing internal organs during computed tomography (CT) scanning.     The standard catheter, which has one hole from which contrast dye enters veins, will be     compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three holes for     diffusing dye into veins. The purpose of this study is to determine which catheter type gives     the best image.   "
26166|NCT02943200|"     The purpose of the study is to determine the prevalence of malocclusion among a group of     Egyptian children with digit sucking aged 3 to 6 years.   "
26167|NCT02943187|"     The purpose of this investigation is to conduct a series of case studies on the impact of a     novel functional medicine approach to improving cognitive skills, brain structure, and daily     functioning for participants with Mild Cognitive Impairment (MCI).   "
26190|NCT02942888|"     The purpose of this study is to determine the effects of Niagen (nicotinamide riboside,     vitamin B3), on NAD levels, brain function including cognition and blood flow in people     diagnosed with mild cognitive impairment (MCI).   "
26168|NCT02943174|"     This investigation aims to apply and test the feasibility of an acceptance, mindfulness and     compassionate-based intervention structured for cancer patients. MIND programme for cancer     thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups     at an Oncology Service at the Coimbra's University Hospital. For each week participants have     assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase     participants' physical and psychosocial quality of life, and attenuate depressed mood and     anxiety. Additionally, this study also intends to explore whether the reduction of depression     and anxiety symptoms will promote better results in the medical treatments of the     participants, and influence the course and prognosis of the illness.   "
26169|NCT02943161|"     This study will evaluate whether treatment with L-citrulline, which is an amino acid found in     some foods, can increase levels of L-arginine and thereby restore the concentration of nitric     oxide (NO) in the airways.   "
26170|NCT02943148|"     Several methods have been used to predict adhesions after abdominal operations.     High-resolution ultrasonography, magnetic resonance imaging and scar healing properties were     the methods that were evaluated in the English literature for this study. Estimating the     likelihood of adhesions and related complications after prior surgery and assessing the     severity of adhesion formation after surgery is not easy. Anticipating adhesions is very     important to preventing complications by ensuring that the necessary preoperative     preparations are in place and/or that appropriate cases are referred to a tertiary center.   "
26171|NCT02943135|"     Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to     grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions     including measuring uterine depth, inserting the insertion tube, and removing the tube; and     placement of the device in the uterus.   "
26172|NCT02943122|"     Preeclamptic pregnancy is associated with alterations in the left ventricular structure and     function and elevation of cardiovascular biomarkers. The alterations are still persistent     several months after delivery and are more clearly observed in early-onset and severe     Pre-eclampsia   "
26173|NCT02943109|"     A large-scale randomized control trial (RCT) of the impact and use of an inpatient     tablet-based patient portal embedded in a larger mixed methods study to examine changes in     patient experiences and outcomes, and subsequent ambulatory patient portal usage.   "
26174|NCT02943096|"     The goal of this proposal is to conduct the first pilot study of whether consuming flavanol     supplements will augment the cognitive and mood benefits of antidepressant medication in     older adults with Late LifeDepression (LLD). Flavanols represent a specific group of plant     derived nutrients that are found in cocoa beans, grapes, tea, berries and various other     fruits and vegetables. The specific flavanols investigated in this study come from cocoa.     Currently available treatments for LLD (i.e., antidepressant medication) are limited in     efficacy, especially in individuals who also suffer from cognitive impairment. Recent studies     performed at Columbia and elsewhere suggest that flavanols may induce beneficial brain     changes that support cognitive functioning and elevate mood, but their precise clinical     effects in older adults with combined depression and cognitive impairment remain to be     evaluated. For this study, the investigators plan to recruit 50 adults aged ≥60 years who     have Major Depressive Disorder, meet a minimum depressive symptom threshold despite currently     receiving an adequate trial of an antidepressant, and have a significant cognitive complaints     without a diagnosis of dementia. Subjects will be randomized to receive 8 weeks of     augmentation treatment with flavanol capsules (in addition to continuing their     antidepressant) vs. capsules not containing flavanols. Pre- and post-treatment MRI scanning     of the brain will be conducted, and comprehensive pre- and post-treatment neuropsychological     assessment will be performed. Results from this project will allow the investigators to     evaluate a novel therapeutic approach to LLD, which could have large public health     ramifications given the prevalence, frequent treatment resistance, and chronicity     characteristic of LLD.   "
26200|NCT02942758|"     Diagnosis: Acute myeloid leukemia refractory to intensive induction chemotherapy; Age ≥ 60     years, no upper age limit; Study drug: low-dose azacitidine, pioglitazone, ATRA; Safety     Run-In Phase; randomized Phase II, open-label        -  Safety Run-In Phase: Based on a 3 + 3 modified design, the tolerable dose of ATRA for          the randomized phase II is defined.        -  Phase II: Experimental Arm: low-dose azacitidine, pioglitazone, ATRA; Standard Arm:          standard-dose azacitidine; in both arms patients can receive further cycles (with no          limit to the number given) as long as clinically appropriate   "
26175|NCT02943083|"     The aims of this study are to determine if:        1. during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving a          pleasing scent (i.e. a relaxation ritual) can, acutely, reduce maternal stress and          affect the fetus (in terms of movement, changes in heart rate and heart rate          variability);        2. a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent          (i.e. a relaxation ritual) during pregnancy can have an effect on mitochondria          functioning in the placenta through reducing maternal stress during pregnancy (based on          our recent findings (Monk et al, 2016));        3. the scent will come to function as a conditioned stimulus such that exposure to the          scent postpartum will induce greater maternal relaxation, which will have an effect on          the mother-infant interaction and infant physiology;        4. prenatal maternal exposure to scent combined with abdominal touch will lead to mothers'          increased likelihood of utilizing infant massage with a lotion of the same scent          postpartum;        5. the prenatal ritual and the increased likelihood of engaging in infant massage will lead          to a maternal perception of greater mother-infant bonding, attachment and parenting          efficacy, and improved maternal mood;        6. the prenatal ritual and the increased likelihood of engaging in infant massage will lead          to improved performance on the conjugate reinforcement paradigm conditioning task          administered to infants at 4 months of age   "
26176|NCT02943070|"     Evaluate the safety and efficacy of the Rezum System for the treatment of BPH   "
26191|NCT02942875|"     Our study aims at investigating the effect of intensive mirror therapy on the motor recovery     of severely impaired paretic arm at subacute stroke.   "
26192|NCT02942862|"     Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the     pathological results. Histoprognostic new factors have recently been published by several     authors, but their validity is still debated.   "
26178|NCT02943044|"     The goal of this study is to determine the optical spectroscopy characteristics of tumor in     patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of     all head and neck cancers. These spectroscopy measurements will be compared with pathological     diagnosis of tissue biopsies from the same site. These readings will be performed in the     operating room during routine endoscopy with biopsy and tumor mapping of patients who have a     suspected squamous cell carcinoma of the head and/or neck. Furthermore, a built in pressure     sensor will be used to compare biopsy sites with their benign counterparts. If successful,     the optical measurements could be used to survey for and delineate the extent of malignancies     in a noninvasive manner. This would be especially helpful for clinic visits where suspicious     lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would     include patients with unknown primaries in which numerous directed biopsies are obtained from     multiple head and neck sites.   "
26179|NCT02943031|"     This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled     in this study. The samples of biliary tract tumors will be collected. Genome sequencing,     mini-PDX and PDX will be performed according to the requirement of individualized precision     therapy programs. Suitable drugs will be chose according to drug screening results. OS and     PFS will be compared with traditional chemotherapy to evaluate the effect of individualized     precision therapy programs.   "
26180|NCT02943018|"     Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound   "
26181|NCT02943005|"     The aim of this study is to compare rehabilitation with the wearing of a sling, to     rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus     tendon. The goal is to offer to patients a simplified rehabilitation management, with a     faster recovery, less pain and a quicker return to normal life.   "
26182|NCT02942992|"     To develop an intervention specifically targeted for these clients who have the frailty     syndrome. The Investigators propose to develop an exercise intervention that can reduce     frailty in older adults to facilitate their ability to age-in-place. The long-term objective     of this work is to develop a package of interventions that can be administered within the     existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal     of this proposal is to develop a resistance exercise intervention to reduce frailty in older     adults receiving long term care services in their home through the Illinois Community Care     Program, a HCBS Waiver Program.   "
26183|NCT02942979|"     This study seeks to implement wrap around services for Veterans suffering from co-occurring     mental illness and substance use and who are homeless. It will compare Implementation as     Usual of MISSION to Facilitation Implementation of MISSION.   "
26184|NCT02942966|"     This is a prospective, multi-center, single-arm, non-blinded study designed to investigate     the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial,     and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post     percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.   "
26185|NCT02942953|"     The diaphragmatic pacemaker (DP) has proven its utility in replacing mechanical ventilation     (MV) in patients with chronic spinal cord injury (SCI) and Amyotrophic Lateral Sclerosis     (ALS), by improving the patients quality of life and reducing morbi-mortality and the     associated health care costs. The anesthetic management of these patients and the     particularities of the surgical procedure represent an anesthetic challenge. The objective of     our study is to analyze the management and the intraoperative complications in the patients     with DP in our institution.   "
26186|NCT02942940|"     Background: Telemedicine is increasingly used to overcome distance between patients and     physicians. Preliminary studies suggest that mobile app follow-up care for ACL reconstruction     patients is feasible, can avert in-person follow-up care, and is cost-effective.      Objective: To avert in-person follow-up through the use of a mobile app in the first six     weeks after surgery.      Methods: This will be a single-center, prospective randomized controlled trial      Results: Data to be analyzed from 72 patients.   "
26247|NCT02942134|"     Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients     with COPD and emphysema. This trial aims to document incidence and severity of augmented     dyspnea in patients with long term NIV therapy. These findings may help in understanding the     pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy schemes.   "
26187|NCT02942927|"     In an aging population, most seniors suffer from multiple chronic conditions. When the number     of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent     medications can do more harm than good. Seniors take an average of 7 regular medications and     studies link polypharmacy with adverse effects on morbidity, function and health service use.     However, it is not clear to what extent these are reversible if medication burden is reduced.      This trial will test the effects on medication numbers and patient health outcomes of an     intervention to polypharmacy. This study will test a program focused on medication reduction     number and dose. Prioritizing medications according to the patient's preference as reducing     the dose also reduces the risk of drug side effects.      Patients, aged over 69 years taking ≥5 medications, will randomly receive the program     immediately or at 6 months. The program involves information gathering from the patient,     including systematically seeking patients priorities and preferences medication review with     the pharmacist and then a consultation with the family doctor. The intervention is focused on     discontinuing/reducing the dose of medications where possible using a 'pause and monitor'     framework to assess the need for restart. An electronic program that detects drug adverse     effects and flags potentially inappropriate medications will be integrated into an electronic     clinical pathway incorporating monitoring and follow up systems.      This study will examine effects on patient and health relevant outcome measures as well as     qualitative research exploring patients' and clinicians' experiences of reducing medication     burden. The results will be used to determine whether this system can be implemented as part     of routine preventative care in primary care for older adults.   "
26188|NCT02942914|"     This trial is conducted to evaluate the safety of a study drug given by injection under the     skin to healthy participants and participants with type 2 diabetes. It will also investigate     how the body processes the study drug and the effect of the study drug on blood sugar levels.     Information about any side effects and tolerability will be documented. This study is     approximately 30 days for each participant, not including screening. Screening is required     within 28 days prior to the start of the study.   "
26196|NCT02942810|"     This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and     female subjects with normal and impaired renal function. The study will be composed of five     groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal     impairment, end stage renal disease patients on hemodialysis (6 patients) and their     respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).     The severity of renal impairment will be assessed based on estimated creatinine clearance     (CLCR) by the Cockcroft-Gault equation   "
26197|NCT02942797|"     This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease     (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to     March 2019. The following variables will be prospectively studied: age, sex, height, weight,     respiratory function indicators, arterial blood gas analysis results, biochemical data,     nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic     outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis     predictor in COPD patients with respiratory failure.   "
26198|NCT02942784|"     This is a retrospective study of patients diagnosed with chronic obstructive pulmonary     disease (COPD) with respiratory failure and admitted in West China Hospital during January     2014 to March 2016 by review of medical records. The following variables will be     retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2,     nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic     outcomes, and so on. The purpose of this study is to compare the predictive power of three     widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic     outcomes in a cohort of COPD patients with respiratory failure.   "
26199|NCT02942771|"     The purpose of this Study is to find out whether an investigational drug is safe and well     tolerated. MW189 is being studied as a possible short-term treatment for people with     different types of brain injury. MW189 has previously been given to healthy human volunteers     as a single dose, and there were no significant problems or bad effects in people who     received the Study drug. However, before it can be tested in people with brain injury, it is     important to test MW189 in healthy volunteers when given multiple doses.   "
26248|NCT02942121|"     The purpose of this study is to learn whether it is feasible to use the LifeScience     Technologies application (LST app) in patients undergoing radical cystectomy with the     eventual goal to reduce complications and readmissions to the hospital after surgery.   "
49886|NCT02632760|"     This randomised double-blind, controlled phase IV trial will compare the efficacy, safety and     cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before     elective cardiac surgery.   "
26201|NCT02942745|"     Areca nut, also known as betel nut, is the fourth most commonly consumed psychoactive     substance in the world, following only alcohol, nicotine, and caffeine in prevalence of     consumption. Although betel nut is chewed by approximately 600 million people globally, its     use is concentrated in South Asia, Southeast Asia, and some Pacific Islands. Betel nut has     been classified as a Group 1 carcinogen by the International Agency for Research on Cancer.     Despite the global significance and carcinogenicity of betel nut, there has been very little     behavioral or psychological research about betel nut chewing, and there has been no     systematic research on the topic of betel nut cessation interventions. The current     intervention builds directly upon the National Institutes of Health - National Cancer     Institute's U54 University of Guam/University of Hawaii Cancer Center Comprehensive     Partnership to Advance Health Equity. Previous data collected through the partnership suggest     that betel nut chewers, like smokers, generally want and intend to quit, but do not have     specific plans of how or when they will quit. In addition, most betel nut chewers in the     partnership's previous study already have tried to quit on one or more occasions. The     findings suggest that betel nut chewers could benefit from cessation programs modeled after     smoking cessation programs. During 2014, partnership investigators conducted a feasibility     study of the betel nut cessation program. The program was well received and yielded     surprisingly high rates of self-reported betel nut cessation.      Specific Aim 1. To test the efficacy of an intensive group-based betel nut cessation program.      Specific Aim 2. To quantitatively determine the efficacy of the group-based betel nut     cessation intervention trial using bio-verification.   "
26202|NCT02942732|"     The investigators examined the effect of vitamin D supplementation on glucose homeostasis and     metabolic markers in healthy normal weight and overweight young subjects and healthy     normal-weight and overweight elderly subjects living in Beirut, Lebanon.   "
26203|NCT02942719|"     1. To describe the average labor curve and establish new labor progression standards.        2. Cesarean section rates: Based on big data, the investigator will introduce the          international advanced Robson class method and identify the appropriate level of          cesarean section rate for each type population.        3. Establishment of Chinese maternal-fetal medical collaboration network and APP to          promote natural childbirth.   "
26204|NCT02942706|"     This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment,     versus continuation after 8 courses of induction therapy with cetuximab plus standard     chemotherapy regimen (FOLFIRI or mFOLFOX6）in metastatic colorectal cancer (mCRC) patients.     The maintenance treatments are continued until disease progression or untolerated toxicity.     The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to     continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or     CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.   "
26205|NCT02942693|"     It is a randomized phase II study to determine the efficacy and safety of particle therapy     with or without apatinib as induction therapy for the treatment of head and neck adenoid     cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly     followed by particle radiotherapy; arm 2: particle radiotherapy alone.   "
26206|NCT02942680|"     evaluate the safety of preoperative aspirin therapy when performing bypass surgery in     conditions of artificial blood circulation   "
26207|NCT02942667|"     The primary objective is to collect high quality MRI data (un-processed or processed) from     participating subjects for Medtronic research purposes.   "
26254|NCT02942043|"     The purpose of this study is to explore the efficacy and safety of different doses of     bevacizumab injection in the treatment of malignant pleural effusion in patients with     advanced non-squamous non-small cell lung cancer.   "
26208|NCT02942654|"     This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is     administered by injection under the skin of the abdomen. The study will be conducted in     healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of     different doses of LY900014 on blood sugar levels. Side effects and tolerability will be     documented. The study will last about 6 to 7 weeks for each participant, including screening     and follow up. Screening is required within 28 days prior to entering the study.   "
26209|NCT02942641|"     Objective: Acute urinary retention (AUR) is a common problem in hospitalized patients. Either     indwelling urethral catheterization or clean intermittent catheterization (CIC) can be the     choice of treatment. In chronic urinary retention, most physicians prefer CIC to chronic     indwelling urethral catheter on the basis of the claim that the rate of catheter-associated     urinary tract infection (CAUTI) is lower.      Method: The patients were randomized into indwelling urethral catheter and CIC groups. The     primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI.     The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.   "
26210|NCT02942628|"     Open label, 6 week randomized, cross-over study to compare the effect of a vegetarian diet to     a conventional (meat containing) diet based on the Swedish average meat consumption on a     range of parameters with prognostic importance for cardiovascular disease.The study will be     conducted in patients diagnosed with ischemic heart disease. We hypothesize that patients     will benefit from a vegetarian diet as assessed by multiple risk markers for this type of     disease with a primary focus on changes in oxidized LDL cholesterol.   "
26211|NCT02942615|"     Under the modern precise radiotherapy technology, clear the best dose volume limit index and     the limit value for the primary level prevention of heart injury; clear best follow-up     interval and measures for heart function of breast cancer patients, to achieve the secondary     prevention of cardiac injury; explore combined cardiovascular specialist optimal treatment     strategy for heart injury in the treatment of breast cancer, during the tertiary prevention     of cardiac injury; put forward rationalization proposal for prevention, treatment and     follow-up for breast cancer associated with heart injury.   "
26212|NCT02942602|"     1) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate     if this test correlates with cardiovascular risk, independent of traditional risk factors; 3)     and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function     and composition   "
26249|NCT02942108|"     The aim of this clinical trial is to investigate and compare the effect of piezoelectric     surgery on tissue, cellular and molecular level of oral surgical wound healing and     postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy     patients   "
26250|NCT02942095|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of ixazomib and erlotinib that can be given to patients with advanced solid     tumors. The safety of these drugs will also be studied.   "
26213|NCT02942589|"     The purpose of this study is to test whether food intake in response to large portion sizes     differs between women who have received portion-control training and women who have not     received such training. In a crossover design, women come to the laboratory on four occasions     to eat a lunch of seven foods varying in energy density. Across meals, all foods are varied     in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy intake is     determined for each meal. Participants are from two groups: women who completed a one-year     weight-loss trial in which they were trained in portion-control strategies, and women who had     not received such training (community controls).   "
26214|NCT02942576|"     There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with     AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to     explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based     antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central     safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies     and invasive procedures.   "
26215|NCT02942563|"     The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal     cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them     even more severer. A number of pilot studies had shown high rate of complete resection after     neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological     complete response (pCR), which was associated with overall survival (OS). Here, the     investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan,     FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation     and to improve the ratio of pCR further.   "
26216|NCT02942550|"     This study will examine the impact of the peripheral opioid antagonist methylnaltrexone on     the onset of effect of ticagrelor in morphine treated patients with ST elevation myocardial     infarction (STEMI). Half of the participants will receive methylnaltrexone, while the other     half will receive placebo.   "
26217|NCT02942537|"     Uterine fibroids are benign tumors that occur most commonly in women of reproductive age.     Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia,     pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention     has been paid to the study of minimally invasive methods for treatment. Microwave ablation of     myomas and endometrium has been shown to have good effect and acceptability has been high.     This study aims to compare the effectiveness, feasibility and acceptability of percutaneous     Cmicrowave ablation and uterine artery embolization for the treatment of uterine myomas in a     randomized single blind study.      Primary outcome      1. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured     as mean volume reduction of the 3 largest fibroids evaluated by magnetic      Power calculation      To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in     microwave ablation and 50%[11] in the embolization group with a standard deviation of 25%     with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to     randomize 32 women.      In order to compensate for loss to follow-up or drop out a total of 36 women will be     randomized.      Patients and investigators will not be blinded. The MRI will be performed and evaluated by a     blinded radiologist.      After having signed informed consent but before randomization patients will undergo MRI of     the uterine fibroids. Patients with a single fibroid measuring more than 6cm will be excluded     from further participation in the study.      All women included in the study after MRI examination will fill in a PBAC evaluation[7]     during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month     prior to treatment.      Microwave ablation will be performed percutaneously using a Covidien Emprint microwave     ablation system. Embolization will be performed in conscious women with an epidural catheter     for pain relief.      At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as     overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the     treatment to a friend.      A new MRI scan will be performed 6 months post treatment (+/-15 days).   "
26218|NCT02942524|"     This clinical trial studies how well a checklist tool works in engaging patients in the     discharge planning process. Engaging patients in the discharge process may increase     participation in the discharge process and improve discharge outcomes, understanding of care     after hospitalization, and decrease complications.   "
26219|NCT02942511|"     To idetify the factors favoring the use of enteral nutrition would be helpful to select     preferred patients suitable for enteral nutrition.   "
26220|NCT02942498|"     The purpose of this study is to determine vitamin C and vitamin E in combination are     effective in the treatment of cognitive and behavior disorder in children with fragile X     syndrome.   "
26221|NCT02942485|"     This study investigates the efficacy and safety of rectally administered metronidazole for     pediatric Giardia lamblia infection, as well as the acceptance of this treatment regimen by     patients/caregivers. The investigators hypothesize that rectal metronidazole is non-inferior     to single-dose of oral tinidazole and will cure at least 72% of patients, a well as will be     tolerated as good as tinidazole.   "
26222|NCT02942472|"     Position of the tip of the inner catheter and air bubbles detection (at time,5min     10min)during embryo transfer influence the pregnancy rate in ICSI cycles .   "
26223|NCT02942459|"     The Aim of this National study is to examine whether music therapy can reduce negative     symptoms and raise Quality of Life for patients suffering from Schizophrenia. It is an     Randomized Controlled Trial (RCT), double-blinded study with two arms. 120 Participants are     anticipated. The two Arms consist of 25 weekly hours of Music Therapy by educated Music     Therapists and time compensated Music Listening by unknown Care Staff Members.      The Study is a close Cooperation between Aalborg University (The Music Therapy Research     Clinic) and Aalborg University Hospital,Psychiatry (The Center of Psychosis Research).   "
26224|NCT02942446|"     This investigation is designed to evaluate the at-home usability, performance, user     acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.   "
26225|NCT02942433|"     Introduction: Change Starts at Home (Change) is a multi-component social behavior change     communication and community engagement strategy designed to prevent intimate partner violence     (IPV), a significant public health issue in Nepal and throughout the world.      Methods and analysis: The study uses a concurrent mixed-methods design. The quantitative     aspect of the evaluation is a pair-matched, repeated cross-sectional 2-armed, single-blinded     cluster trial (RCT: N=36 clusters, 1440 individuals), comparing a social behavior change     communication (SBCC) strategy to radio programming alone for its impact on physical and / or     sexual IPV at the end of programming (12 months' post-baseline) and 6-months post the     cessation of project activities (18-months post baseline). The qualitative aspects of the     design include several longitudinal approaches to understand the impact of the intervention     and examine mechanisms of change including in-depth interviews with participants (N=18     couples), and focus group discussions with community leaders (N=3 groups), and family members     of participants (N=12 groups). Treatment effects will be estimated with generalized logistic     mixed models specified to compare differences in primary outcome from baseline to follow-up,     and baseline to 18-months post following intention-to-treat principles.   "
26226|NCT02942420|"     Subjects on a standard regimen of tiopronin (cystine binding thiol drug; CBTD) plus     prescribed first-line therapy (i.e. on a hydration, alkali therapy and dietary restriction)     who are failing therapy will be selected for this trial.      After completing informed consent, the subject will have Screening consisting of medication     history and physical examination with vital signs. Samples of blood and urine will be taken     for clinical laboratory and urinalysis. Patients will undergo a 12-lead ECG test. A history     of side effects with current CBTD as well as laboratory recordings of abnormalities     attributable to treatment will also be recorded.      Subjects will be dosed in a sequential manner, starting with the low dose group (300 mg/day),     then proceeding to the 600 mg.day dose group.. Safety and tolerability will be monitored     closely by an Independent Medical Monitor (IMM) and based on the IMM's assessment that it is     safe to proceed to the higher dose (600 mg/day), subsequent subjects will be enrolled into     that group. Up to 15 subjects each will be enrolled into either Group A or Group B.      After 7 days on the assigned bucillamine dose, a 24-hour urine sample will be taken and after     completing the Day 8 safety visit, subjects will undergo a 7 day washout where no CBTDs will     be taken. Thereafter, subjects will be allowed to resume their originally prescribed CBTDs     under Investigator's supervision.      One week following study drug discontinuation, subjects will return to the clinic for     follow-up safety assessments.   "
26227|NCT02942407|"     This is a prospective, randomized, open-label, blinded end-point evaluation trial. The     patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and     end-stage renal disease (ESRD) .   "
26228|NCT02942394|"     Primary objective:      To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the     sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by     evaluating different gradations of patency rates, patient's rating of disease severity and     quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein     compression.      Secondary objective:      To assess long-term safety of venous stenting   "
26229|NCT02942381|"     The investigators study will recruit IgA nephropathy patients with proteinuria range from     0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were     treated with Hydroxychloroquine 200-400mg/d according to eGFR. The proteinuria will recorded     every two months and total four months. Then, the drug will be stopped for two months for     observation of change of proteinuria.   "
26255|NCT02942030|"     Attentional symptoms characterize both ADHD and other mental conditions in children.      The diagnosis is based on clinical psychiatric evaluation.      With the expanding knowledge regarding the neurobiological basis in ADHD the investigators     have learned that attention is not a general property of the whole brain, but involves     several coordinated networks. This knowledge promoted the scientific community to the stage     in which scientists can recognize different types of attention domains.      in the current study, the investigators use computerized battery to separate between the     different attention abilities and provide specific attentional profile. in this study the     investigators aim to characterize different attentional profiles in children who are     diagnosed with ADHD versus children who diagnosed with other mental condition (which are     common differential diagnoses of ADHD)   "
26230|NCT02942368|"     This pilot study aims to investigate the potential role of transcranial direct current     stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD).     tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment     of major depression in several studies, both as a primary and adjunctive treatment. The     treatment will be administered under the supervision of a physician with experience in     administering the treatment and monitoring for complications. This will be a prospective     adaptive tDCS stimulation open label research study. Participants will receive 20 minute     sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to 6     weeks. Building on the theory that greater current dose may be a significant factor in     determining efficacy, this study aims to determine whether higher tDCS current doses lead to     greater improvements in depressive symptoms in this population of patients with     treatment-resistant major depressive disorder.   "
26231|NCT02942355|"     This is an open-label, pilot study designed to evaluate the safety and feasibility of     combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line     therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal     patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal     women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an     approved LHRH agonist administered according to its respective prescribing information.     Following informed consent and eligibility check, subjects will be enrolled to either Cohort     A or Cohort B.   "
26232|NCT02942342|"     The primary goal of this study is to determine the prevalence of undiagnosed asymptomatic     coronary artery disease (CAD) in Kalamazoo and its neighboring areas using Coronary Computed     Tomography (CCTA) and Coronary Artery Calcium Score (CACS) to assess if asymptomatic CAD is     widespread enough to warrant implementation of CCTA as a routine screening tool.     Additionally, this study will use the CCTA results to evaluate several methods of assessing     CAD risk in the asymptomatic population including Framingham Risk Score (FRS) and Reynold's     Risk Score, Biomarkers (High sensitivity C-Reactive Protein, Fibrinogen, Vertical Auto     Profile, oxidized Low Density Lipoprotein (LDL), Apolipoprotein A1 (ApoA1), Apolipoprotein B1     (ApoB1), Vitamin D, Homocysteine) as well as a large panel of genetic markers of     atherosclerosis and dyslipidemia.   "
26233|NCT02942329|"     The purpose of this study is to observe and preliminary explore the efficacy and safety of     combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma or     gastric cancer.      Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine     kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of     vatalanib or sorafenib.      SHR-1210 is a humanized anti-PD-1 monoclonal antibody.   "
26234|NCT02942316|"     In this study, the pupillary dilation reflex is measured as a nociceptive indicator during     elective abdominal surgery under general anesthesia.   "
26235|NCT02942303|"     The purpose of this study is to describe three safe and reproducible techniques for brow     lifting using botulinum toxin. It will also describe the effect of 2 techniques on the     eyebrow shape using quantitative, objective measurements and satisfaction scales.   "
26236|NCT02942290|"     This is a randomized, Phase 2, dose-ranging study to evaluate the safety, pharmacokinetics     (PK), and efficacy of venetoclax administered in combination with azacitidine in participants     with treatment-naïve higher-risk (HR) MDS as compared to azacitidine monotherapy.   "
26251|NCT02942082|"     Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.   "
26252|NCT02942069|"     The purpose of this project is to investigate whether the glucose response in type 1 diabetes     patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated     standardized test sessions that include physical activity.   "
26348|NCT02940821|"     Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening:     A randomized, person-centric, comparative effectiveness clinical research study by the     Practitioners Engaged in Applied Research and Learning (PEARL) Network.   "
26237|NCT02942277|"     Background:      Researchers are looking for new ways to control and eradicate malaria. They want to test     vaccines to block malaria transmission in adults in Mali. These vaccines work by inducing     antibodies in a person. The antibody is then taken up with blood by a mosquito that bites the     person. This blocks parasite development in the mosquito. This stops malaria transmission to     another person.      Objective:      To test the safety, reactogenicity, immunogenicity, and transmission-blocking activity of the     vaccines Pfs25M-EPA and Pfs230D1M-EPA with AS01 in Malian adults.      Eligibility:      Healthy Malians ages 18-50 living in certain areas in Mali who:      Are not pregnant or breastfeeding      Are not infected with HIV, Hepatitis B and Hepatitis C      Do not have evidence of immunodeficiency      Do not have history of severe allergic reaction or anaphylaxis      Design:      Participants will be screened with:      Medical history      Physical exam      Malaria Comprehension Exam      Blood and urine tests      Electrocardiogram (for participants in certain study groups)      Participants will be randomly assigned to a study group.      Participants will be monitored for 12-16 months. For the first 7 months, they will have     between 1 and nine visits a month. The number depends on the month and on what group they are     in. For the rest of the months, they will have 1 monthly visit.      Each visit includes a physical exam. Most include blood tests.      Participants will get 3 doses of a study or comparator vaccine. They get the vaccine through     an injection in the upper arm. This occurs at their first visit, then 1 month later, and then     5 months later.      Participants will be followed for at least 6 months after the last vaccine.      If participants develop an injection site rash or reaction, photographs may be taken of the     site.   "
26256|NCT02942017|"     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of     the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in up to 100 adult female     subjects diagnosed with moderate postpartum depression   "
26257|NCT02942004|"     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of     the efficacy, safety, and pharmacokinetics of two dose levels of SAGE-547 Injection in up to     120 adult female subjects diagnosed with severe postpartum depression   "
26258|NCT02941991|"     The purpose of this study is to evaluate the long term safety and tolerability of hESC-RPE     cellular therapy in patients with advanced SMD from 1 to 5 years following the surgical     procedure to implant the hESC-RPE cells.   "
26238|NCT02942264|"     Background:      TG02 is an investigational drug that penetrates the blood-brain barrier and might treat brain     tumors. Temozolomide (TMZ) is a drug used to treat brain tumors.      Objective:      To find out if TG02 is safe, and to find out if it in combination with TMZ is as effective as     TMZ alone in people with brain tumors.      Eligibility:      People ages 18 and older with a brain tumor that has progressed after standard treatment      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      MRI of the brain if they have not had one in 14 days      Heart test      Tissue sample from prior surgeries      Participants will take TG02 plus TMZ by mouth in 28-day cycles.      Some will take TMZ for 7 days on and 7 days off. Others will take it every day.      They will all take TG02 three days before Cycle 1, and then on four days during every cycle.      They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after     each TG02 dose.      They will all keep a diary of when they take the drugs and their symptoms.      Participants will have study visits. These include:      Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests every 4     weeks      Blood tests every 2 weeks      Participants will continue treatment until their disease gets worse or they have intolerable     side effects.      Participants will also be enrolled in another protocol to test molecular markers for their     brain tumor....   "
26239|NCT02942251|"     Major depressive depression(MDD) is an severe public mental disorders. The purpose of current     study is using big data analysis based on clinical features and immunochemistry to     investigate and establish an relapse predict model for patients with first episode MDD.   "
26240|NCT02942238|"     To standardize the surgery for advanced right hemi colon cancer with laparoscopy and     investigate whether extended lymphadenectomy (CME) could improve disease-free survival in     patients with right colon cancer, compared with D3 radical operation in laparoscopic     colectomy.   "
26241|NCT02942225|"     The purpose of this study is to understand the pathophysiological mechanisms of ADHD,     especially the metabolomic pathway related to the behavioral/neuropsychological deficits of     ADHD.      To identify specific metabolites that show significant differences between ADHD and control     groups, both liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry     will be performed. In addition, the behavioral measures include ADHDRS-IV, SNAP-IV, CBCL,     CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including CPT and CANTAB,     will be performed. Conditional logistic regression and partial least squares discriminant     analysis will be applied to identify significant metabolites for ADHD. Pathway enrichment and     topology analyses will be conducted to evaluate the regulated pathways.   "
26242|NCT02942212|"     In-Depth Interviews:      The goal of this research study is to learn about ways to help people might have trouble     understanding health information quit smoking.      Pilot Study:      The goal of this research study is to test 2 different approaches, Standard Treatment (ST)     and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping     smokers who might have trouble understanding health information with quitting smoking.   "
26243|NCT02942199|"     The goal of the MyMOBILE study is to evaluate the feasibility, acceptability, and usability     of a novel platform that integrates text messaging reminders, secure electronic pill     organizers, and daily remote brief motivational recovery support visits with a standardized     protocol for supervised self-administration of buprenorphine via videoconferencing.   "
26244|NCT02942173|"     The purpose of this prospective randomized study is to determine whether infusions of     T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta     T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).   "
26245|NCT02942160|"     A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic     Panniculopathy (commonly known as Cellulite).   "
26246|NCT02942147|"     Objective: The objective of this study is to compare the efficacy of TENS (transcutaneous     electrical nerve stimulation) therapy with those of the conventional radiofrequency and pulse     radiofrequency therapies.      Design: A single-blind randomized controlled trial      Setting: An outpatient physical therapy and rehabilitation clinic      Subjects: The study included 60 patients who presented with a complaint of chronic low back     pain prevailing at least for 3 months and who were diagnosed with facet joint syndrome.      Interventions: The patients were randomized into 3 groups so that Group 1 (n: 20) patients     would receive conventional radiofrequency therapy, Group 2 (n: 20) patients conventional TENS     procedure for 15 days and Group 3 (n: 20) patients pulse radiofrequency therapy.      Main measures: The patients were assessed before treatment, and at month 1 and 6 for pain     (visual analogue scale), disability (Oswestry Disability Index), lumbar movements (hand-floor     distance), functional status (20-meter walking times, 6-min walking distances), quality of     life (Short Form 36), and depression (Beck Depression Inventory).   "
26253|NCT02942056|"     The overall goal of this proposal is to establish the efficacy of cinnamon for the treatment     of T2DM. Additional aims will assess the effect of cinnamon on cardiovascular risk factors     and explore novel potential mechanisms of action leading to improved insulin sensitivity.     Based on previously published animal and human data we have hypothesized that six months     treatment with Cinnamon cassia supplementation (2.25 grams/day) will improve glycemic control     and cardio-metabolic risk factors. We believe these benefits may be mediated in part through     improved insulin mediated capillary recruitment and skeletal muscle vasodilators leading to     reduced insulin resistance. We will achieve our goal through completion of the following     aims:      Aim 1. To demonstrate the efficacy, safety, and tolerability of oral cinnamon use (750 mg     three times daily) to improve glucose control. The primary outcome will be determined as a     reduction in hemglobin A1c (HbA1c) level of at least 0.5% compared to placebo.      Aim 2. To quantify effects of oral cinnamon (vs. placebo) on cardio-metabolic risk factors,     including: fasting levels of plasma insulin and glucose, homeostatic model assessment of     insulin resistance (HOMA-IR), lipids (total, VLDL, LDL, HDL cholesterol; triglyceride), free     fatty acids, as well whole body, abdominal, and visceral adiposity as measured with dual     energy x-ray absorptiometry (DEXA) imaging.      Aim 3. In this mechanistic exploratory aim, potential gastrointesitnal effects will be     assessed as follows: a 3-hour oral glucose tolerance test (OGTT) with blood samples collected     for insulin, glucose, C-peptide, glucagon, GLP-1, and GIP will be performed separately.     Additional biochemical markers (ghrelin, PYY, pro-insulin, apo B, adinopectin) will be     collected as well.   "
26259|NCT02941978|"     The purpose of the study is to investigate the impact of motivational interviewing in the     adherence of patients with AF to oral anticoagulation (OAC) regimens. Half of the patients     will be interviewed and guide on the importance of adherence to OAC medication. Patients     assigned to the intervention group will be contacted at 1 week, 2 months, 6 months and 1 year     after discharge. Patients in the control group will be contacted at 1 year after discharge.   "
26260|NCT02941965|"     This will be a prospective, randomized (1:1 ratio) clinical trial for patients with     male-factor infertility with or without preimplantation genetic screening (PGS). Qualified     650 patients are randomized into either of two groups: group A will undergo intracytoplasmic     sperm injection (ICSI) without PGS (325 cases), Group B will undergo ICSI with PGS (690     cases). The partners of all participants will receive the same protocol for ovarian     stimulation and standardized luteal phase support.      The target population will be patients with male-factor infertility aged between 20 and 50     years, diagnosed by the ESHER Criteria (oligospermia and asthenspermia). Women with other     reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are     excluded.      The randomization will take place before the oocyte pick-up day by a computer randomization     system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal     complications will be followed up by checking medical records and telephone calls.   "
26261|NCT02941952|"     In high-risk patients, it is now recommended to guide the intraoperative volume replacement     via the stroke volume.      Today, the most commonly used technique for estimating the stroke volume is the     transpulmonary thermodilution and the arterial waveform analysis in the radial artery by     PICCO®.      This technique has the disadvantage of being invasive and increasing the time dedicated to     anesthesia during the surgery.      The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has     developed a continuous monitoring technology and non-invasive arterial pressure, cardiac     output and stroke volume using a digital sensor (ClearSight®). This continuous monitoring of     blood pressure was validated in cardiothoracic surgery but studies about monitoring cardiac     output or stroke volume are inconclusive and contradictory.      The objective of this study is to compare the use of non-invasive monitoring of stroke volume     by ClearSight® with the transpulmonary thermodilution and the arterial waveform analysis in     radial artery by PICCO® in abdominal major surgery.   "
26262|NCT02941939|"     Hyperbaric oxygen has previously been tested as a possible means for pre-conditioning to     enhance exercise performance. This study is designed to examine the effects of exercising in     a hyperbaric chamber for improving fitness when combined with high-intensity training.   "
26263|NCT02941926|"     The purpose of this Phase IIIb study is to collect additional safety and efficacy data for     the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2-     advanced breast cancer.   "
28851|NCT02908009|"     This is a prospective, single-center case control comparison of expression of target genes     responsible for energy utilization, mitochondrial function and oxidative stress and levels of     histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients.   "
26264|NCT02941913|"     BACKGROUND: Palonosetron is a second generation serotonin antagonist usually used in a ﬁxed     dose of 75 mcg for the prophylaxis of postoperative nausea and vomiting. Although there are a     few trials evaluating bodyweight-adjusted doses of palonosetron, the ideal dose for obese     patients has not yet been investigated. The aim of this study is to evaluate if the use of     bodyweight-adjusted doses of palonosetron (1mcg / kg) is more effective than a fixed dose     (75mcg) on preventing postoperative nausea and vomiting in female patients with a body mass     index equal to or above 30 kg /m2 whom have undergone breast surgery METHODS: A prospective,     randomized double-blind trial will be conducted at the National Cancer Institute (INCA -     HCIII), in Rio de Janeiro, Brazil. Eligible patients are female aged between 18-70 years of     age with an ASA physical status of one to three, with body mass index equal to or greater     than 30 kg / m2, scheduled to undergo elective breast surgery. Forty patients will be     randomized to receive a fix dose of 75 μg of palonosetron (group I - GI) and 40 patients will     receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII). Patients will     be assessed over 3 time periods: 0-6 h, 6-26 h and 24-48 h after surgery. After discharge,     all patients will be contacted by telephone at regular intervals to record the episodes of     nausea and vomiting as well as analgesic and antiemetic requirements. The primary outcome     measure will include the number of emetic episodes, the incidence of nausea, the need for     rescue antiemetics and the analgesic requirement over 48h. The secondary outcome will be to     evaluate the frequency of polymorphism of the 5-HT3 receptors and their correlation with the     antiemetic effect and adverse effects.   "
26265|NCT02941900|"     The purpose of this study is to learn whether the patient might be interested in skin cancer     genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result from     this testing. Testing for skin cancer risk based on the MC1R gene is not currently used in     clinical practice; it will be offered in this study for research purposes only.   "
26266|NCT02941887|"     This study aimed at correlating global behavior of Down's Syndrome patients to periodontal     disease status.   "
26267|NCT02941874|"     The purpose of this study is on one hand to verify the measurement conformity of the IRAP     dosage and on the other hand to obtain normal values of the blood IRAP concentration on     healthy volunteers.   "
26268|NCT02941861|"     Objective:        1. To study the factors that influence the 3- year recurrence of liver carcinoma after          surgery        2. To study the related factors affecting recurrence of liver carcinoma after surgery   "
26269|NCT02941848|"     The purpose of this study is to evaluate Pharmacokinetic Properties and Safety after     administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in     the healthy adults.   "
26270|NCT02941835|"     The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast     irradiation in female patients with low to intermediate risk breast cancer, who undergo     breast conserving therapy, including a boost dose of irradiation.      An additional goal of this study is to assess tumor response to radiotherapy, by imaging     modalities (PET-CT and MRI) and pathology   "
26295|NCT02941510|"     A randomized, double-blinded study administering budesonide, a medication to reduce     inflammation in the lungs, to healthy volunteers to examine effects on altitude illness     prevention by spending 18 hours overnight at 14,000 ft elevation.   "
26271|NCT02941822|"     This study will evaluate the safety, tolerability and pharmacodynamics of ambroxol in     participants with Parkinson Disease. Participants will administer ambroxol at five dose     levels and will undergo clinical assessments, lumbar punctures, venepuncture, biomarker blood     analysis and cognitive assessment throughout the course of the study.   "
26272|NCT02941809|"     This study evaluates the addition of placebo to the normal treatment course of methadone in     patients who are undergoing treatment for opioid use disorder. All participants will be     enrolled in a methadone outpatient treatment program who have been prescribed a daily regimen     of methadone. Half of the participants will be given a placebo pill (to be taken with the     methadone), and the other half will be given standard treatment of care.   "
26273|NCT02941796|"     To investigate the pharmacokinetic properties and safety after administration of HCP1105 and     co-administration of HGP0918, HGP0816 in healthy male volunteers   "
26274|NCT02941783|"     The objective in this study is collecting post-marketing information on the safety and     efficacy of Kovaltry under the routine clinical practice.   "
26275|NCT02941770|"     The prevalence of pediatric obesity makes this condition a worldwide public health concern.     Physical Activity (PA) is recognized as having many health benefits, many of them related to     obesity and its comorbidities. Despite of all the efforts, the majority of the overweight     children/adolescents still present low levels of PA and high levels of sedentary behaviors.     Thus, it seems that the greatest challenge is to influence behavior change in order to     increase PA exposure in this population. PA consultation can be a cost-effective way of     enhancing PA and improve weight status among overweight children.      The main objective of this study is to analyze if the inclusion of a PA consultation in a     multidisciplinary program for the management of adolescent overweight improves body mass     index (BMI) z-score, PA levels and sedentary behavior outcomes at six and twelve months,     compared to those attending only the Pediatric and the Dietetic consultations.      This study is designed as a non-randomized, controlled clinical trial with six months     duration and follow-up at the 12th month, that will include overweight adolescents (BMI ≥     p85) aged 12 to 17, attending the Clinic for the first time, and accepted to be enrolled.     Those with (i) major pathologies (other than obesity or its related comorbidities), (ii)     inability to perform regular PA, (iii) mental disorders, (iv) smoking habits, (v) under any     kind of prescription (other than antihypertensives or metformine), or (vi) being involved in     another weight loss program will be excluded. According to the sample size calculation, we     expect to recruit 129 participants that will be allocated in three groups by consecutive     sampling: (i) control group - standard care (Pediatric and Dietitian consultations); (ii)     intervention group I - standard care plus PA consultation; (iii) intervention group II - 2     weekly exercise sessions additionally to the standard care and PA consultations..   "
26276|NCT02941757|"     The purpose of this study is to modify the food culture of the fire service by motivating     firefighters and their families to incorporate Mediterranean diet principles at work and home     through behavior change strategies that involve education, participation and incentives. The     ultimate purpose is to lower firefighters' risks for CVD and cancer by successfully getting     more firefighters and their families to adopt and incorporate the healthy eating principles     behind the Mediterranean diet.   "
26357|NCT02940704|"     -  The aim of this study is to assess the postoperative pain and the intake of analgesic          medication after using Reciproc single-file reciprocating system or One Shape          single-file continuous rotary system in patients with symptomatic irreversible pulpitis.        -  Patients will be diagnosed to determine whether they are eligible for the inclusion          criteria of this study or not. Patients who are eligible will then start their root          canal treatment on the same visit and to be completed in one visit only. Patients will          be phone called in order to record the intensity of pain, amount and frequency of          analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.   "
26277|NCT02941744|"     Nivolumab (OpdivoTM, BMS), a human IgG-4 anti-PD-1 monoclonal antibody has demonstrated     anti-tumor activity in patients with advanced melanoma.      The investigators postulate that patients with melanoma nivolumab have a comparable tumor     response rate at a dose range of 0.1 to 10 mg/kg q2wks.      Ipilimumab (YervoyTM, BMS), a human IgG-1 anti-CTLA-4 monoclonal antibody improves the     survival of patients with advanced melanoma. Adjuvant therapy with ipilimumab improves the     relapse-free survival after complete resection of high-risk stage III melanoma (EORTC 18071).      Combined treatment with ipilimumab plus nivolumab improves the tumor response rate and     overall survival of patients with advanced melanoma but is associated with a higher incidence     of immune related adverse events (CheckMate 067).Nivolumab and ipilimumab have distinct     immunological mechanisms that can be revealed by analyzing TCR usage in blood lymphocytes.   "
26278|NCT02941731|"     The purpose of this study is to investigate the bioequivalence after administration of     HIP1403 and HGP0919 suspensions in healthy male volunteers.   "
26279|NCT02941718|"     Most treatment-seeking smokers will fail in their attempts to quit smoking in the early days     and weeks of quitting. Poor sleep (e.g., short duration) is an overlooked, but important     nicotine withdrawal symptom that can affect up to 80% of treatment seeking smokers and     predicts relapse. Addressing sleep deficits could promote cessation, particularly in smokers     who may be vulnerable to poor sleep in one or more sleep metrics even before quitting. This     study will address this conceptual and empirical gap by conducting a 15-week proof-of-concept     study to determine whether standard smoking cessation treatment can be optimized with a     multi-metric sleep advancement counseling intervention.   "
26280|NCT02941705|"     Perform a randomized, double blind, placebo-controlled Phase 2a feasibility study to     determine whether treatment of HFPEF patients with intracoronary allogeneic CDCs affects     clinical functional status (QOL scores), exercise tolerance (6MHW), exercise hemodynamics     (supine exercise ergometry during right heart catheterization), myocardial interstitial     fibrosis (MRI with native T1 mapping and calculation of extracellular volume [ECV] after     gadolinium administration), macroscopic fibrosis by delayed gadolinium enhancement (DGE), and     diastolic function (catheterization, echocardiography, BNP).      Treatment of patients with symptomatic hypertensive heart disease-induced HFPEF with     allogeneic CDCs will be safe and will improve clinical functional status, exercise     tolerance/hemodynamics, myocardial interstitial structure, and diastolic function; the     mechanisms underlying these improvements will be reflected in changes in plasma biomarkers     that indicate a reduction in pro-inflammatory and pro-fibrotic signaling.   "
26281|NCT02941692|"     Oxytocin is a promising new medication found to have positive effects on prosocial behavior,     reduce negative affect such as fear and anxiety, and reduce stress-induced addictive     behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal     oxytocin improves couples' conflict resolution skills and subjective, physiological, and     neuroendocrine responses to conflict. Conflict resolution discussions will take place in the     laboratory and will be videotaped.   "
26282|NCT02941679|"     A phase 3 study to evaluate efficacy and safety of HCP1202   "
26283|NCT02941666|"     Previous studies have shown an increase in the concentration of mesenchymal stem cells     (MSC's) in the setting of osteoarthritis of the knee and its correlation to severity.     Researchers have shown that as there is an increase in the severity of the disease, the     concentration of stem cells also increases. The purpose of this study is to determine if     there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of     the femoral head.   "
26284|NCT02941653|"     Objectives: This study will determine the effectiveness of the use of desensitivity gels     prior in office bleaching on risk and intensity of tooth sensitivity caused by in-office     bleaching using 35% hydrogen peroxide. Materials and Methods: Fourty seven patients will be     selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10     minutes prior to bleaching procedure, patients will receive the the potassium nitrate 2% and     potassium oxalate 5% desensitivity gel application on vestibular surface. The whitening     treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day     interval. Tooth sensitivity will be assessed before, during and 24 hours after the procedure     using analog visual and verbal scales. Color alteration will be assessed by a bleach guide     scale and Vita Easy shade spectrophotometer 7 days after each session. Relative risk to     sensitivity will be calculated and adjusted by session; while comparison of overall risk will     performed by McNemar's test. Data on the sensitivity level for both scales and color shade     will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05).   "
26285|NCT02941640|"     During laparoscopic appendectomy, the base of the appendix is usually secured by an endoloop     ligature or the stapler. Non-absorbable plastic hem-o-lok clip was shown as an alternative     technique with which laparoscopic appendectomy was done faster and cheaper than the standard     techniques. However, biocompatibility of different materials udes in securing the base of     appendix is different. It was observed that stapler's clips made by titanium caused the     mildest inflammatory reaction and creation of adhesions. Disadvantages of stapler's are their     high price.      Titanium clips made for the use in laparoscopic appendectomy are safe and effective option in     securing the appendicular stump in laparoscopic appendectomy. They have potential advantages     over stapler, because they have the same bio compatibility, and their price is lower.   "
26286|NCT02941627|"     The aim of the study is to assess the efficacy and the safety profile of the Neuro Cochlear     Implant System (CIS) in adults with severe to profound sensorineural hearing disabilities.   "
26300|NCT02941445|"     Weight reduction is the most important treatment target in obese women with polycystic ovary     syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone.     Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an     anti-obesity drug but with some limitations, which include high cost and the lack of     long-term efficacy and safety data regarding weight reduction. In addition, weight loss     achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4     inhibitors are weight neutral, they reduced weight regain in animals previously treated with     GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to     evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight     regain more effectively than metformin alone in obese PCOS who had been previously treated     with liraglutide.   "
26287|NCT02941614|"     Many breast cancer patients experience psychological distress during their cancer care     journey. There are effective treatments for breast cancer patients experiencing distress,     such as individual or group therapy, health education, and medication. Unfortunately,     clinicians may not be aware of the symptoms of distress in their breast cancer patients, and     some breast cancer patients who could benefit from referral to behavioral health specialists     are overlooked. New guidelines recommend that all cancer patients be regularly screened for     distress. However, there are unanswered questions about the impact of distress screening     conducted on such a large scale. Few studies have evaluated the impact of distress screening     on important outcomes in breast cancer patients, such as patient experience, symptom     management, and use of health care services, as compared to the usual care offered by the     health care organization. In addition, oncology clinicians are uncertain about the benefits     of large-scale distress screening, and pilot screening programs have not been uniformly     successful, particularly in the community oncology setting.      The overarching goals of this study are to assess the effectiveness of implementing a     guideline-recommended distress screening program for newly diagnosed breast cancer patients     on improving identification and referral to treatment for highly distressed breast cancer     patients, to assess patient-reported outcomes, health services utilization, and     implementation outcomes of the program. This study will address two main research questions:     1) Is a community-oncology based, large-scale distress screening program more effective than     usual care on improved identification of distressed patients, referral to behavioral health     services, and patient-reported outcomes for breast cancer patients? 2) What are the barriers,     facilitators, and other implementation-related outcomes related to distress screening in the     community oncology setting?   "
26288|NCT02941601|"     The main purpose of this study is to evaluate the effectiveness and safety of     gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally     advanced or metastatic squamous non-small cell lung cancer.   "
26289|NCT02941588|"     Recent guidelines of the ACC/AHA suggest that elective non-cardiac surgery (NCS) should     optimally be delayed one year after percutaneous coronary intervention (PCI) with     drug-eluting stent (DES). Regarding the antiplatelet agents, dual antiplatelet therapy, or at     least aspirin is recommended to be continued considering the relative risk of bleeding and     stent thrombosis especially during the first 4 to 6 weeks after DES implantation. However,     these recommendations are based upon insufficient and conflicting evidences.   "
26290|NCT02941575|"     In patients receiving implants in the esthetic zone, would the use of new Nano hybrid ceramic     crown material (Crystal Ultra) improve esthetic patient satisfaction and peri-implant tissue     success when compared with Lithium Disilicate crown (E-max)?   "
26291|NCT02941562|"     The study is designed to analyze the pathological tumor response on locally advanced rectal     cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy     combined with short-course radiotherapy in a prospective cohort and to correlate this     response with patient's outcome   "
26292|NCT02941549|"     The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to     assess the safety and efficacy of orally administered DS102 capsules versus placebo in the     treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)   "
26293|NCT02941536|"     This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic     radiotherapy, in single or fractionated dose, and correlate with the local and distant brain     progression-free survival in patients with metastatic breast cancer.   "
26294|NCT02941523|"     The study evaluates the safety and activity of NOX66 in patients with refractory solid tumors     that are non responsive to standard therapies.      This is a two part with a potential third part, open-label, multicenter, dose escalation     study of NOX66 as monotherapy and in combination with carboplatin.   "
26323|NCT02941146|"     Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.   "
26296|NCT02941497|"     This program is a non-diet approach to obesity prevention for older adolescents which does     not promote following a special diet to manage weight; instead, it promotes healthy behavior     associated with obesity prevention. This approach is especially important with youth and     older adolescent populations so as to avoid impairment in emotional well-being associated     with body dissatisfaction. Healthy weight status will be achieved by improving dietary intake     patterns, increasing physical activity, and improving stress management.      Fall of year 01 was devoted to the recruitment of student partners (intense intervention     group) and the development of partnerships. In the spring of year 01, recruited students were     enrolled in two newly developed undergraduate courses across four intervention state     partners, became collegiate 4-H members, planned a social marketing campaign, and/or learned     to be peer mentors or student researchers. In year 02, first year college students were     recruited, peer mentors were matched with a group of first year students, and the developed     social marketing campaign was pilot tested on four college campuses (diffuse intervention) by     the collegiate 4-H teams. In year 02, a toolkit with 24 weeks of intervention activities was     also refined. In year 03, the collegiate 4-H team (intense intervention group) will use the     refined toolkit to test and implement the intervention on college campuses. In year 03, the     assessment process for high school 4-H students (intense intervention group) will be pilot     tested and college students will work with the high school students on adapting the toolkit     for use in the implementation of the social marketing campaign in high school settings in     year 04 (diffuse intervention). In year 04, the college tool kit will be disseminated to     additional college campuses. In year 05, the program will be disseminated to additional high     schools.      The nine month interactive, social marketing environmental intervention will aid older     adolescents in effectively managing weight through increasing healthfulness of diet,     increased physical activity, and improved stress management behavior as compared to a control     group. On all measures it is anticipated that participants in the intensive intervention     group will have greater improvements than those in the diffuse intervention group and both     intensive and diffuse intervention groups will have improvements over those in the control     groups.   "
26297|NCT02941484|"     Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS     guideline, which was based on studies in patients with gastrointestinal cancer, mainly     colorectal and gastric. Specific clinical study on early oral intake after PD is very     limited. inadequate nutritional intake was significantly associated with a high incidence of     postoperative complications. Therefore, the present study is aim to evaluate the tolerance,     safety, and efficacy in the patients undergoing PD in the age of ERAS.   "
26298|NCT02941471|"     Several transabdominal electrical stimulation studies have been reported for constipation in     childhood. This study aims to assess the efficacy of this technique in adults with chronic     constipation and compare two different electrical therapies.   "
26299|NCT02941458|"     The GECP, in its commitment to improve the treatment and prognosis of patients with lung     cancer and other thoracic tumors, has marked the individualization of treatment according to     the expression of markers predictive of response to chemotherapeutic agents and molecular     inhibitors of cell proliferation as one of its primary objectives. This could significantly     improve the prognosis of patients with lung cancer, and will lead to a radical change in     routine clinical practice. The aim of the register is to explore all data available of all     patients treated because of thoracic tumours.   "
26331|NCT02941042|"     Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of     NNC9204-1177 in Subjects being Overweight or with Obesity   "
26358|NCT02940691|"     This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess     whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus     (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who     inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4 infection.   "
26301|NCT02941432|"     Facial eczema and perioral dermatitis are clinical entities that develop exclusively in the     face and present a special therapeutic challenge. Topical corticosteroids that are commonly     applied to treat eczema/dermatitis at other body sites are best avoided in the face, as they     may result in rapid atrophy of facial skin and in the long term rather aggravate facial     dermatoses. Black tea compresses have been successfully used by German-speaking     dermatologists to treat facial eczema/dermatitis for decades. The precise mechanism of action     is unknown but is presumably based on astringent properties of tannins in the black tea and     on the antiinflammatory action of a wet compress as such. This therapy is cheap, universally     available and practically free of side-effects. Despite these perceived advantages the     effects and tolerance of black tea compresses have not been formally studied to date.     Therefore, the investigators plan to treat 25 patients with facial eczema/perioral dermatitis     over a period of 6 days each within the current trial. The disease activity will be assessed     before, during and after completion of treatment using several clinical scores. In addition,     side-effects, if any, will be documented.   "
26302|NCT02941419|"     Induction of autologous angiogenesis in patients with critical limb ischemia using platelet     lysate.   "
26303|NCT02941406|"     The aim of the present study is to investigate the reproducibility of the MP3 and to compare     the results with conventional perimetry using the Octopus 101 in healthy subjects and     patients with macular disease.   "
26304|NCT02941393|"     In this study, parturients will be randomized to either internal or external tocodynamometry     contractions' follow up. Investigators recruit primiparous, those who try to have vaginal     birth after cesarean section and multiparous, who need oxytocin during labor. Primary     endpoint is the number of operative labors in each group. Secondary endpoints are the     duration of labor, the use of oxytocin and the condition of the newborn.   "
26305|NCT02941380|"     Purpose:      The purpose of this study is to examine cerebral oxidative and inflammatory stress and     cerebral hemodynamics during and after coronary artery bypass grafting and correlate with     postoperative cognitive function.   "
26306|NCT02941367|"     Primary Objective:      To compare the safety, in terms of percentage of patients with symptomatic documented     hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).      Secondary Objectives:        -  To assess effect of lixisenatide versus SU on:        -  Changes in glycemic control;        -  Changes in body weight.        -  To assess overall safety of lixisenatide and SU.   "
26307|NCT02941354|"     This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics     (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to     BMI (body mass index) in subjects with haemophilia A.   "
26308|NCT02941341|"     Non-comparative, observational, ambispective post-authorisation study (EPA-SP).   "
26309|NCT02941328|"     A trial investigating the effects of pyridostigmine (mestinon) versus a placebo in a     double-blind cross over trial in patients with hereditary proximal spinal muscular atrophy     (SMA) types 2, 3 and 4.   "
26310|NCT02941315|"     The investigators aimed to use CMR technique in helping diagnose the etiology of unknown     cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the     extent of myocardial impairment.   "
26324|NCT02941133|"     The purpose of this study is to determine the effectiveness of neural mobilization techniques     compared to standard care treatment in patients with lumbar radiculitis.   "
26311|NCT02941302|"     Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment     planning. In particular, the localization of the border zone between tumor infiltrated and     normal brain tissue is one of the major problems to be solved before beginning therapy.     However, it is a well known problem that, in conventional magnetic resonance imaging (MRI),     it often is difficult to detect areas with low tumor infiltration, especially in gliomas,     because of their infiltrative and often diffuse nature.The study has two purpose:I.To     correlate the imaging border zone with pathological grade of different tumor site following     surgery in patients with newly diagnosed intracranial gliomas, work out the biological border     zone, and complete resect the tumor.II.To determine the feasibility of defining the optimal     target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and     functional imaging.   "
26312|NCT02941289|"     The aim is to understand which components of attentional deployment and selection are     impaired in AD during searching in realistic scenes on a computer screen (Experiment 1) and     in a natural setting (Experiment 2).The investigators will also examine how deficits in     visual exploration may be related to impairments in semantic, long-term memory (LTM) and     working memory (WM) representations by manipulating the semantic consistency between the     target and its visual surroundings, and the type of target cue (abstract vs. precise),     respectively. Perceptual saliency of target and distractor objects will be also manipulated     in Expt.1, In Expt.2, in order to determine how deficits in visual exploration may be     involved in the IADL deficits shown by AD patients, participants at each trial will be     required to search in a natural settings different types of targets and then to perform an     IADL using five objects, among which one of the searched targets. Measures analysed: for the     search tasks (Expt. 1 and 2): eye movements in different search phases, accuracy and response     times; for IADLs tasks (Expt. 2): eye movements during action planning and execution, motor     efficiency (number and types of action performed), time to terminate the activity. Compared     to controls, the investigators expect that AD patients will have reduced ability using scene     semantic LTM in order to locate the objects, greater attentional capture from highly salient     features and greater search performance impairment when higher WM resources are required     (abstract target cues). The investigators also expect that their performance at IADLs will be     less efficient and, in particular, less organized than control, with reduced advantage of eye     guidance.   "
26313|NCT02941276|"     This trial is looking at using an intra-oral electrostimulating device for the management of     radiotherapy-induced dry mouth.   "
26332|NCT02941029|"     This research study is being done to develop a new test to identify prostate cancer patients     at highest risk of radiotherapy-related complications. This research study would allow     monitoring of total tissue damage within 24 hours of radiation exposure in blood samples that     could give an initial result within a few days that would help clinicians make treatment     decisions. Detection of unusual tissue damage at this early time, well before symptoms occur,     could allow doctors to tailor interventions that could include patient therapies that would     reduce or prevent the problems that occur due to treatment of their cancer.   "
26333|NCT02941016|"     This study aim to detect change in vascular inflammation following intense lipid lowering     therapy   "
26314|NCT02941263|"     Background:      Age-related macular degeneration (AMD) affects the macula in the eye. This is the central     part of the retina. It is needed for sharp, clear vision and activities like reading and     driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An     advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive     cells in the macula die so much that central vision decreases.      Objective:      To learn more about geographic atrophy associated with age-related macular degeneration.      Eligibility:      Adults at least 55 years old with a certain kind of GA. They must be enrolled in study     08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies.      Design:      Participants will be screened with medical history, physical exam, and an eye exam.      Participants will have study visits every 3 months for 15 months, then every 6 months. They     will be in the study almost 4 years.      Visits will last about 8 hours. At each visit, participants may have:      Medical and eye history. Participants will answer questions about their general health and     eye health. They may answer written questions about how their eye problems affect their life.      Eye exam and photographs. Eye pressure will be measured and eye movements will be checked.     Pupils will be dilated with drops. The thickness of the retina will be measured and photos of     the eye may be taken....   "
26315|NCT02941250|"     Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in     patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.   "
26316|NCT02941237|"     This study is to test the usability of a new pulse oximeter probe designed for children 0-5     years.   "
26317|NCT02941224|"     The primary objective of the Clinical Investigation is to assess the clinical safety and the     inhibition of restenosis of the Investigational Device in the treatment of de-novo     occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or     popliteal arteries.      The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target     lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index     procedure.   "
26318|NCT02941211|"     Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device   "
26319|NCT02941198|"     To compare two intrauterine systems in order to avoid complications originating from short     pregnancy interval and undesired pregnancies in the early postpartum period.   "
26320|NCT02941185|"     Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is     recommended there is no consensus regarding the adequate dose of supplementation for preterm     infants.   "
26321|NCT02941172|"     This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and     other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in     room temperature conditions and during controlled cold exposure, and the density of CB1     receptors in BAT and other tissues will be quantified. The investigators hypothesize, that     cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.      Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is     important and beneficial in fighting against the epidemic of obesity and diabetes.   "
26322|NCT02941159|"     The purpose of this study is to assess the safety and tolerability of SF2000SD in adult male     healthy volunteers   "
26326|NCT02941107|"     Australian Indigenous children, particularly those living in remote communities, suffer a     disproportionately high burden of rotavirus gastroenteritis disease. Despite the introduction     of rotavirus vaccine into the Northern Territory (NT) Immunisation Schedule in 2006, the rate     of hospitalization for rotavirus in NT Aboriginal children < 5 years continues to be high,     and the rate ratio of rotavirus hospitalisations for Indigenous versus non-Indigenous     children has actually increased. The reasons for sub-optimal vaccine response are not     completely understood, but both reduced vaccine immune responses and low vaccine coverage are     likely to be important factors.      The purpose of this study is to determine if Aboriginal children who receive an additional     dose of RV1 between the ages of 6 and 12 months, will have an increase anti-rotavirus serum     IgA seroconversion and decreased medical presentations with gastroenteritis in the first     three years of life, compared to those who receive placebo.   "
26327|NCT02941094|"     Ultrasound guidance has been established as an effective and safe method during insertion of     internal jugular vein catheter.. Needle visualization during advancement toward the vein has     a great impact on both safety and success of the procedure. Clinicians have adopted variable     techniques to increase needle visualization including changing needle- probe relation     (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the     inserting needle and the probe lying on patient skin affects both the distance to the vein     and the length of the needle part travelling through the us beam   "
26328|NCT02941081|"     This study aims to determine whether IHAT is non-inferior to ferrous sulphate at correcting     iron deficiency and anaemia, and if IHAT does not increase diarrhoea risk in young children     living in rural and resource-poor areas of the Gambia.      The study hypothesis is that IHAT will eliminate iron deficiency and improve haemoglobin     levels in young children without increasing infectious diarrhoea or promoting inflammation in     the gut.   "
26329|NCT02941068|"     This prospective intended to observe the influence of prophylactic and empirical anti-fungal     treatment on Severe Sepsis patients with perforations. With the consent of patients' legal     guardian for prophylactic use of antifungal agents, patients were divided into two groups:     prophylactic group and Empirical group.   "
26330|NCT02941055|"     Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the     population, and where many patients in spite of modern pharmacological treatment fail to     reach remission. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory     Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will     decrease disease activity and improve quality of life in patients with established RA.   "
26337|NCT02940964|"     Abstract      Introduction      Bystander cardiopulmonary resuscitation (CPR) can more than double the patient's chance of     survival in Out-of-hospital cardiac arrest (OHCA). In Singapore, bystander CPR rate was low.     Recent studies have proposed and validated the use of popular songs as aids in performing     CPR. These songs may not be widely known when applied to a different population, and further,     may lose popularity over time. Count on me Singapore (COMS) is believed to be known to over     90% of the Singapore population. Pilot data indicated that CPR performed using COMS as a     mental metronome (COMSCPR) can achieve guideline-compliant rate of chest compression with     lower fatigue level than CPR guided by the conventional one-and-two-three-and (Standard     CPR). The investigators hypothesize that COMSCPR is non-inferior to Standard CPR in achieving     guideline-compliant rate of chest compression.      Methodology      The investigators planned a prospective, randomized, crossover non-inferiority trial     comparing COMS CPR and Standard CPR. 80 eligible volunteers will be recruited from a     convenience sample of camp personnel from a military training camp. After a 15 minutes     familiarization session, they will be randomized into two groups (A and B). Group A will     proceed to perform one cycle (two minutes) of Standard CPR, while group B will proceed to     perform one cycle of COMS CPR. participants will cross over to perform one cycle of the other     method of CPR. After completing this second cycle, a survey form will be administered. The     Laerdal SkillReporter will be used to measure the CPR performed. After a 7-14 days interval,     participants will be recalled to attend a test scenario. Statistical analysis will be used to     compare the two arms.   "
26338|NCT02940951|"     Older adults living with incurable and advancing life-limiting illness frequently desire to     spend as much time as possible comfortably at home, rather than in hospital. They often have     complex problems that not only affect their ability to function, but also their and their     family caregivers' overall quality of life (QOL). Routine assessment of their perceived     health care needs and their self-reported QOL is necessary to ensure that patients' and     family caregivers' concerns are visible to home care clinicians so that they can be     effectively monitored and addressed. These types of assessments involve asking people to     respond to questions about their symptoms, their physical, psychological, social and     existential/spiritual wellbeing, and their experiences with the care provided. Handheld     electronic information systems are increasingly used and recommended to facilitate such QOL     assessments. However, there is a need for information about how such systems are best     translated into practice improvements that ultimately may improve patient- and family-centred     outcomes.      This study is about the implementation of an electronic tablet-based innovative health care     information system, the Quality of life Assessment and Practice Support System (QPSS), into     routine care provided by home care services for older adults with life-limiting illnesses and     their family caregivers. Nine home care sites in Canada are participating. At each site the     investigators will first adapt the QPSS to the local context and develop a plan for its local     implementation. Then home care staff will be asked to use it in practice and the     investigators will evaluate the process of using the QPSS and its effect on patient and     family caregiver quality of life, health, and satisfaction with care as well as the cost     consequences of its integration into practice. The effect of its use will be studied in a     randomized trial, which is the part of the study described in this registry. Patients and     their family caregivers will be randomly assigned to 1) have their home care team use the     QPSS in their care or 2) not to use it, instead receiving care as usual. The effect of using     the QPSS will be measured using questionnaires completed by the participating patients and     family caregivers every two months. If using the QPSS improves quality of life, health, or     satisfaction with care, the last stage will explore how to scale up use of the QPSS in     practice and its integration with existing health information systems.   "
26339|NCT02940938|"     The purpose of this study is to evaluate the variations of respiratory changes in pulse     oximeter plethysmographic amplitude (delta POP) according to different contact forces between     finger and sensor of pulse oximeter. During general anesthesia without surgical stimuli,     pulse oximeter sensor is applied with serial contact force, from 0 to maximal 1.5N (increased     by 0.2N) and POP waveform is obtained for 60 seconds. Delta POP will be calculated and     compared.   "
26340|NCT02940925|"     The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND     CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with     concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in     endemic area.   "
26341|NCT02940912|"     The purpose of the study is to demonstrate that continuous apomorphine treatment during the     night compared with placebo improves sleep quality in insomniac patient with Parkinson's     disease.   "
26342|NCT02940899|"     Syracuse University Fit Families is designed to increase the activity level and frequency of     the children through modified activities using adapted equipment and, importantly, to     increase the families' comfort level in having their children participate in a variety of     physical activities, including team and individual sports.   "
26343|NCT02940886|"     Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects     suffering from IDA   "
26344|NCT02940873|"     Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood     sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel     when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH),     increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe     hypoglycaemia reduced when people are taught how to adjust their insulin around their     life-styles through structured education but problematic hypoglycaemia may persist. Many     people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts about     hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot benefit     from conventional treatments to reduce hypoglycaemia. The investigators developed the     Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic     hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that     combines revision of knowledge about hypoglycaemia avoidance with psychological therapies     that directly address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over     six weeks, by diabetes educators to groups of 6 people. In a pilot study, severe     hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and recurrent     severe hypoglycaemia.      The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an     established educational intervention (Blood Glucose Awareness Training, BGAT) which has also     been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic     hypoglycaemia persisting despite otherwise optimised insulin self-management will be     recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4     centres. The investigators will measure severe hypoglycaemia over two years following     courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.   "
26345|NCT02940860|"     Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects     with IDA and NDD-CKD.   "
26346|NCT02940847|"     The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the     distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow.     The anesthesia of the posterior and the medial side of the arm requires a selective block of     the medial brachial cutaneous nerve and the intercostobrachial nerve, for example to improve     the tolerance of the inflatable tourniquet used by the surgeons. There are two techniques to     achieve this block : the blind technique (without ultrasound) and the ultrasound-guided     technique. At the moment, there are no studies which compare these two techniques. So, the     purpose of this study is to determine the effectiveness of ultrasound-guided technique     compared to blind technique in medial brachial cutaneous nerve block and intercostobrachial     nerve block, in the axilla.   "
26347|NCT02940834|"     Observational study about prevalence, predictors of sodium imbalance and prognostic     significance.   "
26349|NCT02940808|"     Cognitive control driven by the prefrontal cortex (PFC) of the brain is thought to be     important for goal-directed control over stimulus-driven processes. EEG-measured spontaneous     theta/beta ratio (TBR) may potentially be used as an electrophysiological marker for this     PFC-mediated cognitive control. In the present study the investigators further examine TBR as     an electrophysiological marker for cognitive control, by administering caffeine to forty     healthy female participants. After a first training session, participants will visit the lab     twice in separate weeks, during which they will orally consume one capsule containing 200mg     of caffeine, and one capsule containing a placebo substance (double-blind and random order of     administration). EEG will be measured before and after capsule consumption, and cognitive     control tasks will be administered after capsule consumption. Generally, the investigators     expect that caffeine will decrease TBR and thereby increase cognitive control. Additionally,     the investigators expect that individual differences in baseline frontal (reflected by TBR)     and central dopaminergic (reflected by spontaneously-measured eye-blink rates; EBR) activity     will moderate the relationship between caffeine and cognitive control. Furthermore, the     effects of caffeine on specifically hypervigilance for threatening distractors (taking into     account a possible moderating role of trait anxiety) were examined as a separate research     question.   "
26350|NCT02940795|"     The majority of pregnant women in the United States are either overweight or obese at     conception with their offspring having greater adiposity at birth, a 2-fold greater risk of     later obesity and neonatal insulin resistance.      Conventional wisdom holds that breast-milk composition is uniform; recently our group has     questioned this. An increase in consumption of dietary sugars including fructose over the     past 30 years has risen, and this has been associated with chronic metabolic and endocrine     disorders and phenotypic alterations that promote obesity and diabetes. However, no prior     studies have examined how maternal increases of sugars/fructose during lactation affects     breast-milk composition with potential transmission to the infant. The objective of this     proposal is to comprehensively assess the presence and pharmacokinetics of sugars, including     fructose in human breast-milk in response to maternal consumption. The central hypothesis is     that a graded, dose-response relationship be-tween maternal adiposity and sugar     concentrations in breast-milk exist and that milk fructose concentrations are associated with     altered body composition in the first months of life. This proposal, guided by compelling     preliminary data will examine the evidence linking high intakes of milk fructose with altered     metabolism and early obesity by pursuing two Specific Aims: 1) Test novel relationships     between breast-milk sugars and changes in infant fat mass and 2) Characterize the     pharmacokinetics of milk sugars after consuming a 20 oz. cola. These aims are significant     given the intractability of obesity/diabetes and a potentially identifiable novel target,     making for a clear but powerful public message to reduce sugary beverage consumption during     lactation.   "
26351|NCT02940782|"     A randomized clinical trial to assess postoperative pain in patients with symptomatic     irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.   "
26352|NCT02940769|"     The primary study objective is to observe/measure the circadian pattern of sleep, Cortisol     and Melatonin in MDD subjects and Control subjects. We will also assess if controlled     exposure to light in MDD subjects (post-partum females, non- post-partum females and males)     will change these parameters using light glasses. In addition to the biological outcome     measures (sleep, cortisol and melatonin) we will also monitor sleep and depressive symptoms     in the research subjects for the duration of the protocol.   "
26398|NCT02940171|"     Prognosis of burn patients has improved over the last decades. Early excision of full     thickness burns is thought to be one of the key factors which have led to prognostic     improvement. Best timing for burn excision remain uncertain however. In this multicenter     observational study, we aim at exploring the impact of timing of surgery on outcome in     severely ill patients using a propensity analysis.   "
26353|NCT02940756|"     The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in     Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to     play a major role in the malaria control in the region. The National Malaria Control program     recommends artemisinin-based combination treatments (ACTs), in particular     artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated     malaria. Previous studies indicated that ACTs are still effective, with efficacy above the     required threshold of 90%. It is required to assess regularly the efficacy of antimalarial     drugs, in order to ascertain the relevance of treatment guidelines such that, in case of     increasing failure rates, alternative options can be decided ontime.      The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ     Winthrop®), artemether-lumefantrine (Coartem Dispersible®) and     dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated     Plasmodium falciparum malaria in six surveillance sites around DRC.   "
26354|NCT02940743|"     The purpose of this randomized clinical trial is to evaluate alternative technology-supported     behavioral approaches to engaging 42 maintenance hemodialysis (HD) patients with persistent     hyperphosphatemia in phosphorus binder adherence and dietary phosphorus restriction.     Participants will be randomized to 1 of 3 intervention groups: (1) Education (Edu); (2) Edu +     Self-Monitoring (SM); or (3) Edu + SM + Social Cognitive Theory (SCT)-based training program.   "
26355|NCT02940730|"     This study will evaluate the pharmacokinetic properties of dalbavancin when administered as     an intravenous infusion and instilled into the peritoneal space in patients who are     undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed by     intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the     patients will then receive dalbavancin instilled into their peritoneal space followed by the     same intensive plasma and peritoneal dialyses fluid sampling.   "
26356|NCT02940717|"     Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic.     Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material     with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and     laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be     used to fabricate laminate veneers but the investigators have to know clinically it is     fracture resistance, so the investigators are going to have Parallel groups in a randomized     clinical trial.   "
26372|NCT02940509|"     The goal of this research proposal is to determine if the intraoperative administrative of     Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in     patients on chronic opioid therapy for management of chronic pelvic pain.   "
26373|NCT02940496|"     The goal of this clinical research study is to learn about the safety and tolerability of     pembrolizumab when given to patients with advanced liver cancer.   "
26359|NCT02940678|"     Trauma is one of the top threats to population health globally. A substantial body of     research has been devoted to the development of clinical prediction models to aid early     decision making in trauma care. Often these models are applied outside the context in which     they were originally developed. In contrast, very little research has focused on the effects     on model performance of such transfers despite the fact that a potential loss in performance     could have devastating consequences.      Data from the Swedish trauma registry SweTrau will be used to study the effects on model     performance of transfers between different contexts within a single conceptually homogenous     setting. Using logistic regression models for predicting all-cause mortality within 30 days     of trauma in adult patients will be developed, focusing on systolic blood pressure,     respiratory rate, and Glasgow coma scale as predictors.      Four different sets of data sampled from SweTrau will be used to simulate transfer of models     between high and low volume centres, metropolitan and non-metropolitan centres, multicentre     and single centre data, and finally between individual centres. Measures of overall     performance, clinical usefulness, discrimination, calibration, and recalibration will be used     to quantify the effects on performance of model transfers.      The study will provide evidence to help clinicians and policy makers in deciding on whether     it is appropriate to apply models developed in other contexts. For example, the results of     this study may inform decisions on the development and implementation of models intended to     be applied on a national or regional level, and ultimately help designing better trauma care     and improve the outcomes of trauma patients.   "
26360|NCT02940665|"     The primary objective of this prospective cohort study is to compare protein intake and     adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with     patients receiving conventional care. The study will also compare energy intakes, gut     function, and clinical outcomes between groups. The ability of nutritional parameters,     including preoperative malnutrition risk and postoperative protein intake, to predict length     of hospital stay will be evaluated.   "
26361|NCT02940652|"     The aim of the trial is to obtain and to describe the position of the laryngeal mask during     elective magnetic resonance imaging in paediatric patient. The radiologic findings will be     compared to the clinical performance of the laryngeal mask.   "
26362|NCT02940639|"     A Real-Life Study to Evaluate Efficacy and Safety of Nivolumab in Patients with Advanced     Renal Cell Carcinoma after prior therapy.   "
26364|NCT02940613|"     This study has two aims: 1) to test the validity of an eating disorder symptom checklist     against an established clinical interview; and 2) to examine whether providing eating     disorder patients with visual graphs of their symptom frequency in the early sessions of     active treatment will lead to higher numbers of patients achieving a rapid response (65%     reduction in symptoms in the first 4 weeks of treatment). Groups where patients receive     visual graphs of symptom frequency will be compared with groups where patients do not receive     visual graphs of symptom frequency on rates of rapid response to cognitive behavior treatment     for eating disorders.   "
26365|NCT02940600|"     The purpose of this study is to evaluate the impact of normothermic machine perfusion in     liver transplantation using grafts of brain death donors older or equal than 70 years   "
26366|NCT02940587|"     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a     prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated     using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)   "
26367|NCT02940574|"     The current trial aims to explore the neural and behavioral effects of oxytocin in autism     spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and     supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of     complex social behaviors. Initial studies showed that intranasal administration of oxytocin     can have a positive effect on social functioning in ASD.      However, future studies are necessary to explore whether and how oxytocin effects neural     processes in the brain underlying these behavioral improvements. This trial will not only     measure behavioral enhancements, but will specifically focus on elucidating the associated     neurophysiological changes by guiding the administration of oxytocin with regular     neurophysiological assessments.   "
26368|NCT02940561|"     To characterize the pharmacokinetic profile of the Test product - Methotrexate Tablets USP,     2.5 mg of Amneal Pharmaceuticals, compared to that of the corresponding Reference product -     Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc. in patients with     mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of     2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their     bioequivalence.   "
26369|NCT02940548|"     This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure     rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives.     Half of participants will receive Nifedipine GITS, half of half will take medicine in the     morning or at night. While the other half participants will take amlodipine besylate, whom     will also be assigned taking medicine in the morning or at night. Ambulatory blood pressure     monitoring and arterial stiffness examination will be performed before and after     pharmaceutical intervention.   "
26370|NCT02940535|"     The management of the poor responder patients is very difficult. Currently, there is no any     standard treatment for poor responder patients. The study is designed to test a modified     GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation,     compare with GnRHa ultra-short protocol. This is a randomized controlled trial.   "
26371|NCT02940522|"     To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable     bioavailability to a single IM injection of Makena®.   "
26375|NCT02940470|"     The primary objective of this pilot study is to determine the effect of weight loss on a wide     range of biomarkers associated with risk of breast cancer recurrence in overweight and obese     breast cancer survivors. We hypothesized that weight loss would result in a statistically     significant improvement in biomarkers associated with risk of breast cancer recurrence.   "
26376|NCT02940457|"     This study investigates the beneficial effects of prefrontal brain stimulation (with     transcranial direct current stimulation [tDCS]) during working memory training in seniors     with mild cognitive impairments.The placebo-controlled double blinded study includes 50     elderly patients which will be randomized into verum or sham tDCS.   "
26377|NCT02940444|"     Thromboembolism is an important perioperative complication in major thoracic surgery, even     though current guidelines have recommended postoperative administration of heparin or LMWH     for thromboprophylaxis for those high-risk patients, there are still many cases of     thromboembolism. Therefore, as the guideline itself writes, the investigators believe the     rational of dose and timing of heparin in thoracic surgery are still not well established.     Therefore, the investigators aimed to conduct this randomized controlled study to explore the     safety and efficacy of preoperative Administration of Heparin as Thromboprophylaxis in Major     Thoracic Surgery.   "
26378|NCT02940431|"     The purpose of this study is to look at the effects of active video game play on youth     physical activity.   "
26379|NCT02940418|"     Allogenic adipose derived mesenchymal stem cells will be injected into patients newly     diagnosed with type 1 Diabetes Mellitus   "
26380|NCT02940405|"     The aim of this study to assess effect of ketorolac premedication on the effectiveness of the     inferior alveolar nerve block, pretreatment and postoperative pain in patients with     symptomatic irreversible pulpitis.   "
26381|NCT02940392|"     Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering     from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).   "
26382|NCT02940379|"     Primary Objective:      To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A     activities using a CYP probe cocktail of metoprolol and midazolam.      Secondary Objective:      To assess the clinical and laboratory safety of sotagliflozin coadministered with the     cocktail probes as compared to that of cocktail probes alone.   "
26383|NCT02940366|"     This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control     in patients with metabolic syndrome.   "
26384|NCT02940353|"     Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the     treatment of edentulous or patients with failing mandibular dentition over 5 years. 90     patients (15 per centre) will be included. The subject population is at least 18 years old,     in need of an implant restored full prosthesis providing sufficient bone in the     interforaminal where a fixed restoration on three implants is regarded as an appropriate     treatment solution. The components are TREFOIL treatment concept (implants and framework).   "
26385|NCT02940340|"     Infective endocarditis (IE) is a severe clinical condition with a high in-hospital and 5-year     mortality. It has a growing incidence, both related to healthcare and possibly to changes in     prophylaxis recommendations regarding oral procedures. Though not a new disease, several     aspects in its clinical and laboratory diagnosis remain to be better studied and innovated.     The evaluation of systemic microvascular disease has proven crucial in the investigation and     comprehension of pathophysiology of cardiovascular diseases, as well as a tool for early     diagnosis and prediction of complications. Few studies deal with microcirculation in patients     with IE, and so far none utilizing speckle contrast imaging and functional capillary density.     The present study will contribute to the investigation of microcirculatory changes in IE and     possibly to earlier diagnosis of the condition and/or of its severity and complications. The     aim of the study is to evaluate the changes in microvascular bed of patients with both acute     and subacute endocarditis by speckle contrast imaging and skin video-capillaroscopy.   "
26399|NCT02940158|"     The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup     servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of     starchy foods (corn, macaroni, white potato, white rice).   "
26386|NCT02940327|"     Respiratory failure in newborns is common and has high rates of death. Where conventional     intensive care strategies have failed, newborn children are referred to treatment with Extra-     Corporeal Membrane Oxygenation (ECMO). This involves connecting children via large bore     cannulas placed in their heart and major blood vessels to an artificial lung that adds oxygen     to their blood and removes waste gases (carbon dioxide). Although this treatment saves lives,     it still has some limitations. In particular, severe complications like bleeding, or damage     to the kidneys can occur. These complications can lead to death in some cases and long-term     disability in others. Based on ongoing research in adults and children undergoing cardiac     surgery the investigators have identified a new process that may underlie some of the     complications observed in ECMO. The investigators have noted that when transfused blood is     infused in an ECMO circuit, this results in the accelerated release of substances from the     donor cells that cause organ damage; at least in adults. There are treatments that can     reverse this process. Before the investigators explore whether these treatments should be     used in newborn children on ECMO, the investigators must first demonstrate that they can     measure the complex inflammatory processes that occur in these critically ill children. The     investigators therefore propose to conduct a feasibility study to identify the practical     issues and challenges that would need to be overcome in order to perform a successful trial     in this high-risk population.   "
26387|NCT02940314|"     The purpose of this study is to compare the safety and pharmacokinetic characteristics after     administration of HIP1503 and HGP1103 in healthy male volunteers.   "
26388|NCT02940301|"     This phase II trial studies how well ibrutinib and nivolumab work in treating patients with     classical Hodgkin lymphoma that has come back or has not responded to treatment. Ibrutinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by     targeting certain cells. Giving ibrutinib and nivolumab may work better in treating patients     with classical Hodgkin lymphoma.   "
26415|NCT02939950|"     The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb     samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared     to the Bausch + Lomb PureVision® contact lens when worn for 7-day extended wear by adapted     soft contact lens wearers.   "
26389|NCT02940288|"     Auricular (ear) acupuncture treatment involves placing filiform needles in the ears at     particular locations called acupoints. Although the mechanism for acupuncture analgesia is     still unclear, it is believed ear acupoints work like reflex points that once stimulated with     penetration by a needle have the ability to relieve pain in a different part of the body.      The purpose of this study is to explore the safety and effects of auricular acupuncture     therapy on postoperative analgesic consumption and pain scores immediately following     laparoscopic surgery.   "
26390|NCT02940275|"     This is an observational clinical study, patients with systemic diseases will be enrolled     according to the inclusion and exclusion criteria. Patients will received the examination of     sublingual microcirculation by using incident dark field video microscope (Cytocam，Braedius     Battery Powered Transilluminator). The microcirculation data includes total small vessel     density, perfused small vessel density, microvascular flow index, and heterogeneity index.     The patients will be divided into right groups according to their systemic diseases as     follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3     hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis     (60), group 5 kidney transplant recipients (60), group 6 coronary artery disease (60), and     group 7 peripheral arterial occlusive disease (60).   "
26391|NCT02940262|"     This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed     tomography (CT) works in detecting prostate cancer that has come back in patients after     initial therapy. Diagnostic procedures, such as 68Ga-PSMA-11PET/CT, may help doctors detect     tumors that have come back after initial therapy.   "
26392|NCT02940249|"     Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within     the body and eventually lead to the development of type 2 diabetes. Previous research by this     group has shown that an apple polyphenol extract reduced hyperglycaemia following a     high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of     the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory     polypeptide concentrations following a mixed carbohydrate test meal.   "
26393|NCT02940236|"     To assess possible risk of aspiration with pre-operative oral medications taken with sips     of water (100ml).   "
26394|NCT02940223|"     The goal of this clinical research study is to learn about the effects of combining physical     activity with fish oil to treat fatigue in patients with advanced cancer receiving     regorafenib.   "
26395|NCT02940210|"     A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy     and safety of adhesion barrier Mediclore versus no treatment in patients with total     thyroidectomy   "
26396|NCT02940197|"     Background: Obesity treatment should be individualized since some calorie restricted diet     doesn't work for some individuals.      Objective: we assess the effect of two different calorie restriction with MediterrAsian diet     on weight loss of FTO rs9939609 carriers with overweight.      Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly     allocated in two interventional group [group 1: Mediterrasian diet according to adjusted     ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories     restriction (NRD)+ Moderate physical activity]. Anthropometric indices will be assesses for     all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly.     Metabolic indices, physical activity and psychologic aspects will be assesses at baseline and     the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0, 30     and 60. At the end of the study, we compare carriers with different alleles (AA+TA and TT) in     two intervention groups to find out which calorie restriction is appropriate for each     genotype. Significant p-value is less than 0.05.   "
26397|NCT02940184|"     Investigation of the importance of vagal signaling for the glucohomeostatic effects of GLP-1.     The study will include physiological studies of truncally vagotomized participants and     matched controls.   "
29895|NCT02894372|"     The purpose of the study was to assess the effectiveness of Faringomoss in reducing the     throat discomfort and pain in patients with acute throat diseases and postoperative patients     after throat surgeries.   "
26400|NCT02940145|"     The main purpose of the present study was to investigate the effects of 12 weeks of     resistance training (RT) on phase angle (PhA), body composition, inflammatory and oxidative     stress biomarkers, in older women and to evaluate whether RT induced adaptations on body     composition, inflammatory and oxidative stress biomarkers are related to healthy adaptations     in PhA.   "
26401|NCT02940132|"     SC10914 is a potent selective PARP-1 and PARP-2 inhibitor. This study aims to determine the     safety , tolerability , pharmacokinetic/pharmacodynamics profile of increasing doses of     SC10914 when administered orally to patients with advanced solid tumors. Furthermore, the     safety and efficacy of SC10914 in patients with advanced solid tumors and negative expression     of ATM or BRCA1 or BRCA2 mutation will be evaluated in expanded cohorts to establish the     Recommended Phase 2 Dose(RP2D).   "
26402|NCT02940119|"     Pain in the neck and shoulders is a musculoskeletal disorder that affects a significant     number of individuals.The aim of this study is to evaluate the effects of PBMT (with a device     that combines low level laser therapy and light emitting diode therapy) in chronic pain     relief of musculoskeletal origin in the neck and shoulders area.   "
26403|NCT02940106|"     This randomized pilot study will assess if there is a difference in clinical pregnancies     using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.   "
26416|NCT02939937|"     Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it     presents as subacute monocular visual loss that develops over several days.      As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term     beneficial effect on vision.      There are a number of factors that contribute to nerve fibre damage including increased level     of sodium, so blocking sodium entry could help to protect them against damage.      The main objective of the study is determine whether phenytoin (which blocks sodium entry)     can protect nerve fibre and improve final visual function after optic neuritis.   "
26404|NCT02940093|"     The combined analysis of microbiome, immunological parameters and host genetics in patients     has potential for applying personalized approaches of prevention, diagnostics or therapy in     the future. However, the acquisition and analysis of these patient characteristics in a     scientifically sound, technically reliable, cost-effective, practicable and future-oriented     fashion are a far from trivial task. Therefore the objectives of the study are (i) to     optimize a sample and data acquisition and analysis pipeline that fulfills these criteria     (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children     undergoing stem cell transplantation, yielding information on host immuno-genetics, gut     immune function and the human gut microbiome; (iii) deduct the most critical parameters for     host-microbiome interplay from this complex dataset.   "
26405|NCT02940080|"     A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects     of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins     extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia     will be compared. Additionally, the postprandial metabolism and metabolites, and the     appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine     and feces.   "
26406|NCT02940067|"     This is a pilot study to investigate the effect of prehabilitation on patients undergoing     elective surgery for pancreatic disease.   "
26407|NCT02940054|"     Observational prospective study to validate a new index for early diagnosis of Crohn's     disease (CD)   "
26408|NCT02940041|"     Determine the concordance between gynaecological sonography and pelvic MRI for the     pre-surgical diagnosis of uterine malignant tumors.   "
26409|NCT02940028|"     The ICU is a stressful and challenging place for patients and their families. Many family     members experience anxiety, depression, and posttraumatic stress disorder during and after     their ICU experience. The investigators are studying post-traumatic growth in this study.     Post-traumatic growth (PTG) is a set of positive changes that occurs after a challenging or     difficult life experience. This study investigates the effects of expressive writing on     positive changes that occur after a difficult experience .PTG will be compared between the     intervention group receiving the expressive writing intervention and the control group     (non-expressive or fact based writing).   "
26410|NCT02940015|"     Background:      Scientists want to improve new studies on how the environment, diet, and genetic factors     affect human health. To do this, they need biological samples and clinical data. They want to     find better ways to collect, handle, store, and test these samples and data. This could make     them more useful for research.      Objective:      To collect anonymous samples and clinical data from people. To find better ways to collect,     handle, store, and test them to support health research.      Eligibility:      Healthy people ages 18 and older      Design:      Participants will complete a screening form by phone or in person. The form could include     questions about age, race, ethnicity, menopause status, or pregnancy.      Participants will donate a specific amount of a sample. This could be blood, breast milk,     cerumen, ear wax, exhaled breath, hair, mucosal or skin cells, nail clippings, saliva, semen,     stool, or urine.      Participants may provide an environmental sample such as dust, water, soil, air, or plant     life.      Participants may get kits to collect their samples. They may also donate them at a clinic     visit.      Visit will take about 30 minutes. They may include:      Sample collection      Questions about diet, smoking, alcohol use, medication, menstrual cycle, and health      Measurement of body composition, naturally occurring radioactivity, or Doppler blood flow      Moderate exercise      Flexibility, muscle strength, or sensory testing      Participants may be asked to participate several times during the study.   "
26411|NCT02940002|"     To explore the efficacy and safety of four BAY1003803 formulations by means of a within     subject comparison in an open Psoriasis Plaque Test   "
26412|NCT02939989|"     The purpose of this study is to evaluate the efficacy and safety of co-administration of     ABT-493/ABT-530 plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV)     genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic     participants) who have experienced virologic failure in an AbbVie parent clinical study.   "
26439|NCT02939638|"     This randomized, controlled trial aims to elucidate the mechanisms by which a plant-based     dietary intervention causes weight loss. Using a low-fat, plant-based diet for 16 weeks,     along with an untreated control for comparison, the study will measure changes in insulin     sensitivity, postprandial metabolism, and intracellular lipid, and assess their associations     with changes in body weight.   "
26413|NCT02939976|"     Patients with partially blocked blood vessel(s) in their heart may need a medical procedure     called Percutaneous Coronary Intervention (PCI) to open the narrowed blood vessel(s). The     purpose of this study is to simultaneously address four potential advances in ST-Elevation     Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are     looking to see if these advances can improve the outcome for these patients.        1. Opening the arteries with a Medtronic stent        2. Radial access (from wrist) success with a Medtronic stent        3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide          wires.        4. Reduced bleeding and vascular complications with radial arterial access for primary PCI          in STEMI.   "
26418|NCT02939911|"     Residual neuromuscular blockade (RNB) is frequent and it is associated with postoperative     morbidity and mortality. The incidence of the RNB in pediatric anesthesia is currently not     known. The aim of this prospective observational cohort study is to evaluate the early RNB     just before extubation and late RNB at the time of arrival to postanesthetic care unit     (PACU).   "
26419|NCT02939898|"     The goal of this project is to identify autocrine, paracrine and endocrine factors which are     associated with intercycle variation in cyclical follicle recruitment.      Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the     stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or     placebo during ovarian stimulation.   "
26420|NCT02939885|"     The purpose of the study is to better define and understand the brain mechanisms related to     emotional and cognitive dimensions using odorous stimuli, gustatory stimuli, visual stimuli     and auditory stimuli using functional Magnetic Resonance Imaging (fMRI).   "
26421|NCT02939872|"     The purpose of this study is to evaluate optimal duration of antiplatelet therapy after     Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic     events.   "
26422|NCT02939859|"     Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived     cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via     intravascular system of quality of life and alteration of documented Muscular Sclerosis (MS)     and related neurodegenerative patients. It is believed that the heterogeneous cell population     which includes multipotent stem/stromal cells are capable of immune modulation/inflammatory     modulation properties. Exam of disease progression and quality of life changes will be     evaluated.   "
26423|NCT02939846|"     Present clinical study will be conducted in China to evaluate the pharmacokinetics of single     and repeat oral doses of trametinib, the safety profile and the clinical activity in Chinese     subjects with solid tumor. Approximately 10 evaluable subjects will be enrolled in the study,     Subjects will receive trametinib 2 mg once daily (QD). Study treatment will continue until     disease progression, death or unacceptable toxicity. The study will be completed after all     subjects have discontinued from study treatment or last enrolled subject has had at least 16     weeks of follow-up, whichever occurs first.   "
26424|NCT02939833|"     Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One     group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will     receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin     insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before     surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control     medicine and NRS score at the first three days after surgery, ratio of intracranial infection     within 30d after surgery, and total hospitalization days and medical expenditure will also be     recorded and compared between the two groups.   "
26425|NCT02939820|"     The purpose of this study is to provide expanded access of patisiran to patients with     hereditary transthyretin-mediated amyloidosis (hATTR).   "
26426|NCT02939807|"     This is a Phase II efficacy study of single agent ABC294640. Patients with advanced     hepatocellular carcinoma (HCC) who have experienced tumor progression with 1st line single     agent sorafenib will receive ABC294640 500 mg po bid continuously.      Patients will continue on therapy until the development of progressive disease per modified     RECIST, intolerable toxicity, withdrawal of patient consent or other event as outlined in     patient discontinuation.   "
26427|NCT02939794|"     Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under     went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion)     and more than 80% of the patients receives at least one unit of red blood cell transfusion.      There were number of attempts to prevent the postoperative anemia by giving erythropoietin,     Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after     the cardiac surgery.   "
26428|NCT02939781|"     Fever is part of the body's immune response, often triggered by infection. Fever is commonly     treated with medicines such as paracetamol, mainly because people feel unwell with fever.     However fever does have a role in fighting infection: it enables the rest of the immune     system to function more efficiently, and may directly stop bacteria and viruses from     multiplying. In most cases however treating fever does not matter because the rest of the     immune system can cope well enough to fight the infection (with or without additional     treatment, like antibiotics).      In critically ill patients however any advantage in the fight against infection may be     crucial. In a large observational study of adult patients in the intensive care unit,     patients who developed an early fever with temperature between 38.5-39.5 degrees C fared     relatively better than patients who were colder. So it is possible that in critical illness     fever may be beneficial. However in critical illness the body does have limited energy     resources. In order to raise the body temperature energy is required. However the     investigators do not know how much energy is required to generate a fever in critically ill     children. This study will aim to try and measure the energy required to generate a fever in a     critically ill child. The investigators will measure energy expenditure directly in children     admitted to the intensive care unit by measuring the levels of oxygen and carbon dioxide they     breathe in and out (a method called indirect calorimetry). This will enable the investigators     to judge whether the benefits of a fever can be justified by the energy costs in the energy     depleted state that is critical illness.   "
26467|NCT02939274|"     The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low-     Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of     cutaneous metastases of breast cancer for which no curative or significantly palliative     therapy exists, including chest wall therapy.   "
26429|NCT02939768|"     Background: Type 1 diabetes mellitus (T1DM) is characterized by the destruction of β cells     and consequent loss of insulin secretion due an autoimmune process, being associated with     increased cardiovascular risk, oxidative stress and inflammation.      Considering that most people with T1DM do not reach recommended levels of physical activity     due to concern about the rapid drop in blood sugar and the excuse of lack of time, shorter     sessions of exercise that provide several benefits should be encouraged. Thus, this work aims     to compare the effects of high-intensity interval training (HIIT), strength training (ST) and     both interventions on several blood markers and functional parameters in T1DM patients.      Study hypothesis: (1) ST+HIIT will be more beneficial than HIIT, which in turn will be more     beneficial than ST, on modification of blood levels of pro and anti-inflammatory, pro and     antioxidant, lipid, renal and glucose metabolism parameters and (2) ST+HIIT will be more     beneficial than HIIT, which in turn will be more beneficial than ST, on modification of     functional parameters, body composition and maximal oxygen uptake.   "
26430|NCT02939755|"     To test the efficacy of a web-based stepped collaborative care intervention to reduce     symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL)     in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors     in caregivers.   "
26431|NCT02939742|"     The purpose of this study is to determine if a repeat course of betamethasone given to     pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's     length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity     associated with this condition.   "
26432|NCT02939729|"     The purpose of this study is to determine the effects of a physiotherapy prehabilitation     programme (walking and deep breathing exercises) in cardiac or thoracic patients by measuring     changes in lung volumes, functional capacity physiotherapy length of stay postoperatively.   "
26433|NCT02939716|"     When patients have bowel surgery they are sometimes left with a stoma, where the small bowel     exits onto the wall of the abdomen, not into the colon. Certain foods have been shown to     increase the amount of water lost through a stoma. This can lead to dehydration. Such     patients are encouraged to avoid such foods but knowing which ones to avoid relies partly on     trial and error.      In a survey 1 in 3 patients said that rhubarb increased stoma output. Rhubarb is known to     contain chemicals that can stimulate the bowel. 1 in 6 patients also reported the same effect     with lettuce which has not previously been shown to have such an effect. Latex found in     lettuce leaves may stimulate the bowel to produce more fluid, explaining this effect.      In Nottingham the investigators have developed techniques that use Magnetic Resonance Imaging     (MRI) to measure water in the small bowel. They want to use these techniques to explore     whether eating lettuce increase small bowel water content. They will compare lettuce to     rhubarb and to bread, which they know reduces small bowel water. They will see if they can     detect any relationship between water in the bowel and feelings of bloating.   "
26434|NCT02939703|"     The purpose of this study is to collect data to examine how diet impacts the composition and     function of the bacteria in your large intestine.   "
26435|NCT02939690|"     In this randomized clinical study, neonates who require umbilical venous catheter (UVC)     insertion as part of their routine care at anytime during their NICU admission will be     randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth (umbilicus     to the nipple in cm minus 1 (UN - 1) or birth weight based formula ([(3× birth weight (Kg) +     9)/2+1)]. UVC will be inserted under sterile condition as per unit protocol. To verify the     UVC tip position, a thoracoabdominal radiograph will be taken. In addition, the investigators     will do a ultrasound of the heart to assess the exact location of the catheter tips as soon     as possible but within 6 hours of insertion.   "
26436|NCT02939677|"     Anterior cruciate ligament reconstruction (ACLR) is high volume surgery, carried out in about     2800 patients annually in Denmark per year. ACLR patients (using hamstring auto-graft) have     persistent hamstring strength deficiency when evaluated more than 1-2 years after     ACL-reconstruction. The investigators have designed this randomized controlled trial (RCT)     with the main purpose to investigate the effect of a targeted muscle strength exercise     intervention on the neuromuscular rehabilitation of ACLR-patients compared with 'care-as-     usual'.      The study is designed as a prospective, superiority, parallel-group with balanced     randomization (1:1) RCT (Level of evidence: II) with blinded allocation, and outcome     assessment according to the CONSORT statement (Consolidated Standards of Reporting Trials).     50 patients with ACL reconstruction and persistent hamstring muscle deficiency, will be     recruited at the outpatient clinic 1-year follow-up, and allocated to one of two 12 weeks'     interventions, either a) the supervised progressive strength and neuromuscular exercise group     (SNG) with supervised training twice weekly. Or b) the control group (CON) receiving patient     education based on a home-based exercise regime of low intensity, defined as 'care as usual'.     Outcome measures include, maximal isometric knee flexor muscle strength (primary outcome),     knee extensor strength, and the Knee injury and Osteoarthritis Outcome Score (KOOS)     (secondary outcomes). In addition, the following explorative outcomes will be investigated;     hamstring to quadriceps strength ratios, the International Knee Documentation Committee     Subjective Knee Form (IKDC), magnetic resonance imaging (MRI) to evaluate tendon regeneration     of the hamstrings and finally kinetic/kinematic biomechanical outcomes of knee related     functional tasks.      To the investigators knowledge, this is the first RCT to investigate the efficacy of combined     progressive resistance training and neuromuscular exercise in the late rehabilitation phase     in patients demonstrating persistent limb-to-limb knee muscle asymmetry following ACLR.     Reduced hamstring strength represents a potential risk factor for secondary ligament rupture     and accelerated progression of osteoarthritis (OA). If deemed effective, the intervention     paradigm introduced in this study may help to improve current treatment strategies.   "
26437|NCT02939664|"     This study try to identify differences in length of operation, weight loss and complications,     between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric     bypass and the laparoscopic Roux-en-Y banded gastric bypass. The study will be conducted in a     Spanish public health system hospital. The patients of the trial will have the preoperative     studies, hospital treatment during the admission, postoperative treatment and follow up as     any other patient included in the hospital bariatric surgery program. The study cases will     have placed around the gastric pouch a band of polypropylene mesh, and will be randomly     choose between the participants.      Patients will be randomized in a 5/3 (study/control) ratio.   "
26438|NCT02939651|"     The purpose of this research study is to test if pembrolizumab is safe and effective for     treating patients with metastatic high-grade neuroendocrine tumors who have failed platinum     based chemotherapy.The study drug, pembrolizumab has been FDA approved for treating a type of     skin cancer called melanoma and for metastatic non-small cell lung cancer. However, it is not     approved for treatment of metastatic high-grade neuroendocrine tumors.   "
26479|NCT02938364|"     The aim of this study is to evaluate the efficacy of two proposed non-invasive techniques:     the ear plug technique and acupressure on the P6 point in reducing gag reflex during     impression making and to assess patient's experience in terms of comfort and satisfaction.   "
26440|NCT02939625|"     Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness     and chronic airway inflammation and pharmacological treatment for this condition is done with     bronchodilators and anti-inflammatory. Pharmacologic therapy has clinical efficacy in the     control, but the patient often does not adhere adequately.      There is need for further research into non-pharmacological therapies for clinical asthma     control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial     effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that     these therapies also have effects on the BIE.      The aim of this study is to evaluate the effect of these non-pharmacological therapies in     several variables and especially the BIE.   "
26441|NCT02939612|"     The purpose with this study is to test the effect of an app for stress management among     patients with different cancer diagnosis.   "
26442|NCT02939599|"     This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in     adult patients with PAH. This study provides the patients who completed the QCC374X2201 study     with the option to continue receiving QCC374. The study will monitor the long-term safety,     tolerability and efficacy of QCC374 in patients with PAH.   "
26443|NCT02939586|"     Sleep disturbance is a significant issue in people undergoing dialysis. More than 80% of     haemodialysis patients complain of difficulty sleeping. Inadequate sleep can cause poor     daytime function and increased risk of motor vehicle incidents.      One of the common reasons for sleep disturbance in dialysis patients is sleep apnoea. Sleep     apnoea involves pauses in breathing that occur during sleep. Each pause can last only a few     seconds or minutes. Severe sleep apnoea reduces oxygen supply and increases risk of heart     attack and stroke, which are the leading causes of death in dialysis patients.      In this project, the investigators will examine how a change of dialysis treatment might     improve sleep. This project will first identify patients at risk of sleep disturbance using     surveys and a subsequent sleep study. The investigators will then test different dialysis     models to see the effect of dialysis treatment on sleep apnoea. The aim is to find a dialysis     model that works better for patients with sleep apnoea.   "
26444|NCT02939573|"     Multi-center sequential multiple assignment randomized trial comparing the effectiveness of     three different standard of care treatment options for patients with isolated skin     vasculitis.   "
26445|NCT02939560|"     The goal of this proposal is to investigate whether a standard rTMS protocol for depression,     including multiple sessions applied to left dorsolateral prefrontal cortex (DLPFC) results in     reduction of depressive symptoms for adult patients with ASD and MDD (Aim 1). The secondary     goal is to investigate and whether there is any beneficial reduction in the core symptoms of     autism (Aim 2).   "
26446|NCT02939547|"     This research study is being conducted to find out whether Trappsol® Cyclo™, an experimental     treatment for people with Niemann Pick disease Type C (NPC-1) is safe at 2 different dose     levels and what effects it has on people who have this condition. NPC-1 is caused by a defect     in the protein which is important for the transport of fatty substances like cholesterol out     of cells. Without this protein, fats build up in the cells ultimately leading to organ     damage. The way in which this experimental treatment works is not fully understood but     laboratory experiments have shown that it can potentially remove cholesterol build up from     the cells in people who have NPC-1. Approximately 12 patients will be asked to take part in     this research study for up to 20 weeks (w) in total (including screening. treatment and     follow-up). Recruitment is expected to take 6- 9 months.Patients who take part will receive     treatment by an intravenous infusion every two weeks. The study will look at what the body     does to the drug as well as what the drug does to the body by taking and examining blood and     urine samples. Samples of cerebrospinal fluid (CSF) will be taken by lumbar puncture during     and following the first and subsequent treatment doses. Liver and skin biopsy specimens will     be taken to assess filipin staining. Cholesterol metabolism will be investigated in liver     samples and splenic and hepatic elasticity will be assessed by ultrasound..Patients will also     have their hearing tested, be asked questions by their doctor as well completing     questionnaires to help assess any changes in their condition during treatment.This study is     being sponsored and funded by CTD holdings Inc. It is planned to be run in the USA,.   "
26447|NCT02939534|"     The way the immune system responds to certain PD-related proteins in PD donors compared to     the way it responds in persons without or fewer PD related proteins is not well studied and     this study aims to analyze the autoimmune response in each group. The study involves a one     time visit involving brief questionnaires and a blood draw of 30 mL (approximately 2     tablespoons) to be collected.   "
26448|NCT02939521|"     A prospective design that studies the effects of a new technique for the treatment of pincer     nails. The technique consists of a flattening of the bone of the distal phalanx with a     frontal skin lifting that is performed in patients with a pincer nail deformity. Visual     Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.   "
26449|NCT02939508|"     This prospective study was designed to compare the difference of effects of conventional     treatment, medicine intervention, endoscopic therapy, and surgery between colon originated     and non-colon originated ALGID in critical patients, in order to alert doctors to differ the     treatment of the two ALGID and provide basis for treatment.   "
26450|NCT02939495|"     The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil     30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile     dysfunction.   "
26451|NCT02939482|"     The purpose of this study is to determine the effects of different rates of Caudal Epidural     Steroid Injection (CESI) on clinical outcomes of the patients.   "
26452|NCT02939469|"     Since the invention of electrocardiogram (ECG), ECG has been an important part of clinical     practice. A primary reason for the popularity of the ECG is that it is non-invasive and can     be performed in any patient by placing electrodes on the skin. The present methods of ECG     recording focus on detecting electrical signals from the heart. the investigators propose     that with high frequency sampling and high pass filtering, the investigators can also record     SNA from the skin. The somata of the subcutaneous sympathetic nerves on the skin are located     at the ipsilateral cervical and stellate ganglia. Because the left stellate ganglion nerve     activity (SGNA) is known to trigger cardiac arrhythmias, including AF, VF and VF, It is     possible that skin SNA can also be used for arrhythmia prediction. the investigators tested     that hypothesis in our preclinical studies (supported by R01 HL71140) using canine models.     The results showed that subcutaneous nerve activity (SCNA) recorded with implanted electrodes     can be used to estimate stellate ganglion nerve activity(SGNA) in normal dogs and in a canine     model of ventricular arrhythmia and sudden death. the investigators also showed that SCNA is     more accurate than heart rate variability in estimating cardiac sympathetic tone in     ambulatory dogs with myocardial infarction.Therefore, SKNA and SCNA may be useful in     estimating cardiac sympathetic tone. In addition to studying the autonomic mechanisms of     cardiac arrhythmia, these new methods may have broad application in studying both cardiac and     non-cardiac diseases. For example, sympathetic tone is important in the pathogenesis of heart     failure, atherosclerosis, peripheral neuropathies, epilepsy, vasovagal syncope, renal     failure, hypertension and many others diseases. Direct SKNA and SCNA recording may provide     new approaches to study the mechanisms of these common diseases. SKNA recording may also have     immediate clinical applications by assisting in the diagnosis and treatment of hyperhidrosis     (sweaty palms), paralysis, stroke, diabetes, and neuromuscular diseases. It may be used to     assist biofeedback monitoring performed by neurologists to control neuropsychiatric     disorders. Because of these potential clinical and commercial applications, the investigators     propose that this research project is significant.      b. Innovation        -  Using conventional electrodes on the skin to record SNA. The neuECG utilizes the          conventional skin electrodes that are widely used in health care facilities. Skin SNA          had been recorded using microneurography techniques, and had been estimated using          cutaneous blood flow (vasodilator responses) skin temperature, skin conductance and          sweat release. However, microneurography cannot be used in ambulatory patients. The          other methods are not direct measurements of SNA. neuECG is the first method that can          directly and non-invasively measure the SNA from the skin.        -  Automated real-time signal processing. the investigators will develop signal processing          software to automatically eliminate noise, such as that generated by muscle contraction,          electrical appliances, body motion, respiration, and radiofrequency signals. The          remaining signals are then processed to separately display in real time to provide          health care providers a new method to instantly estimate sympathetic tone. The ECG          signals are used for automated arrhythmia detection while the SNA signals are available          for risk stratification. This approach allows us to improve and broaden the clinical          application of Einthoven's original invention by simultaneous detecting ECG and SNA from          the skin.        -  SKNA patterns as new biomarkers. the investigators have identified unique SKNA patterns          that precede the onset of human AF. If proven correct by Specific Aim 3, this new          biomarker can help physicians to estimate the arrhythmia risk and to predict the          efficacy of catheter ablation for AF.   "
26453|NCT02939456|"     This is a pilot study taking place at University Hospitals of North Midlands NHS Trust.     Patients referred for MRI for possible prostate cancer will be invited to take part in the     study. Following consent, participants will have an additional MRI sequence performed during     their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).      Participants scan images and prostate biopsy histology report (if applicable) will be     reviewed by the research team.   "
26480|NCT02938351|"     The aims of the present study will be to pilot test the efficacy of a collaborative care     intervention in patients treated with dialysis to reduce symptoms of depression, pain, sleep,     fatigue and improve quality of life.   "
26454|NCT02939443|"     Background: The aim of this study was to investigate the efficacy of prone-position computed     tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT     before laparoscopic inguinal hernia repair.      Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal     preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients     diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine     and prone positions for preoperative assessment. The anatomy of the right and left inguinal     regions was confirmed during the surgery and compared with the preoperative CT findings.   "
26455|NCT02939430|"     Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation.     benefits of reversal of neuromuscular blockade appears to be of great value in living donor     liver transplant recipients. However, Few Clinical reports have investigated the     anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile     of living donor liver transplantation will be investigated.   "
26456|NCT02939417|"     The aim of this study is to evaluate the clinical performance of E-max veneers cemented with     and without using grape seed extract before bonding.   "
26457|NCT02939404|"     One reason people gain weight is eating more calories from food than what they need for     energy over 24 hours. Metabolism is the amount of energy a person uses over 24 hours.     Researchers want to study the relationship between changes in metabolism and how much a     person eats.      Objectives:      To see how much food a person eats when the body's temperature is cooled. To study how     changes in metabolism may alter the amount of food a person eats.      Eligibility:      Healthy people ages 18-55.      Design:      Participants will stay at NIH for 20 days.      During the first 4 days, participants will have:        -  Medical exam        -  Electrocardiogram        -  Blood and urine tests. One blood test includes drinking a sugar solution.        -  DXA body composition scan        -  Questions about foods they like, physical activity, and personal behavior        -  Exercise test on a stationary bicycle      Participants will spend 24-hour periods in a metabolic chamber. The chamber will be at normal     room temperature or cooler.      Some times, participants will eat a diet that matches their daily needs. Other times, they     can eat as much as they wish from a vending machine.      Participants will have blood and urine collected.      Participants will swallow an ingestible wireless sensor and wear a small data recorder     device.      On the second to last day, participants will stay in the metabolic chamber but only consume     water and non-caffeinated sugar-free beverages.      Participants will come back for 1-day visits at six months and one year from the first     admission. They will have blood and urine tests, and a DXA scan. They will answer questions     on physical activity and food habits.   "
26458|NCT02939391|"     The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's     disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score     between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.   "
26459|NCT02939378|"     Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in     vitro.      Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic     adjuvant to salvage chemotherapy for recurrent glioblastoma.   "
26460|NCT02939365|"     The purpose of this study is to determine the safety and feasibility of converting patients     to Belatacept monotherapy (receiving just one immunosuppression drug), and to see what     percentage of those patients can be safely converted to once every 8 week administration of     Belatacept. Belatacept has been approved by the Food and Drug Administration (FDA) for kidney     transplant recipients.   "
26461|NCT02939352|"     High relapse rates among substance dependent individuals are likely due to a combination of     factors that involve limbic circuits in the brain involved in craving, including     vulnerability to salient cues. Emerging data suggests that non-invasive, targeted brain     stimulation may be able to modulate activity in these circuits and decrease craving. The     primary goal of this pilot study is to determine the extent to which a single session of     continuous theta burst stimulation (TBS) to the medial prefrontal cortex can attenuate limbic     circuitry involved in craving among cocaine users and alcohol users. This will be tested     through a double-blind,sham-controlled brain stimulation and brain imaging study in a cohort     of polysubstance abusers and alcohol users.   "
26462|NCT02939339|"     The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an     effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The     study consists of six total visits to MUSC; one for the consent process, two that will     include MRI scans, and five that will include TMS administration. Compensation will be     provided for each visit.   "
26463|NCT02939326|"     To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar     frown lines (GL).   "
26464|NCT02939313|"     The goal of this investigation is to determine if, in heavy alcohol users, a single session     of transcranial magnetic brain stimulation (TMS) over a brain region involved in craving     (medial prefrontal cortex) and a brain region involved in cogntive control (dorsolateral     prefrontal cortex) can lower an individual's craving and brain response to alcohol cues. This     study involves a screening visit, followed by three visits which involve brain imaging (using     functional MRI) and brain stimulation (using TMS). There is also an additional Magnetic     resonance spectroscopy (MRS) exploratory Aim in which we will measure the concentration of     glutamate in the prefrontal cortex before and after a session of TMS.   "
26465|NCT02939300|"     This research study is studying a combination of two drugs as a possible treatment for     Leptomeningeal Metastases from Melanoma.      The names of the study interventions involved in this study are:        -  Ipilimumab        -  Nivolumab   "
26466|NCT02939287|"     The purpose of this study is to help answer the following research question:        -  Whether administration of an aprepitant containing regimen or an olanzapine containing          regimen will prevent nausea and vomiting better for patients undergoing an autologous          stem cell transplant with melphalan chemotherapy. Both of these medications are approved          by the United States Food and Drug Administration (FDA) for nausea and vomiting.        -  Participants will be randomly assigned to one of the 2 treatment groups:             -  Arm A: aprepitant plus standard anti-emetic regimen             -  Arm B: olanzapine plus standard anti-emetic regimen   "
26468|NCT02939261|"     The overall objective of this research is to test, among families with children age 2-5     years, the immediate and longer-term impacts of a home-based intervention to improve     household routines associated with reduced obesity risk. The investigators primary hypothesis     is that, compared to control, children in the intervention group will have lower BMI     following the 6-month intervention period and 18-month follow-up period. The secondary     outcomes are change in children's % body fat, waist circumference and obesity-related     behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although     child outcomes are the focus of this evaluation, changing household routines may also improve     parent behaviour; thus, the investigators will assess change in parent behaviours and weight     outcomes. This study will also assess the cost-effectiveness of the intervention from a     societal perspective.   "
49887|NCT02632747|"     This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial     with empagliflozin compared to placebo that is added to open-label ramipril in patients with     type 1 diabetes.   "
26469|NCT02939248|"     The purpose of this study is to evaluate differences in the pharmacokinetics and     pharmacodynamics of ticagrelor and its active metabolite between patients who received     ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and     morphine alone for unstable angina pectoris.   "
26470|NCT02939235|"     The purpose of this study is to evaluate differences in the pharmacokinetics and     pharmacodynamics of ticagrelor and its active metabolite between patients who received     ticagrelor and morphine followed by metoclopramide versus patients treated with ticagrelor     and morphine alone for unstable angina pectoris.   "
26471|NCT02939222|"     Implant placement may trigger bone trauma, which might result in 3-dimensional bone changes.     While the process of peri-implant disease is not well understood, implant position within the     bony structure might play a role. However, there is no data available on this regard.   "
26472|NCT02939209|"     Arthroscopic shoulder rotator cuff repair is associated with severe postoperative pain. The     interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by     anesthetizing the nerves that supply the shoulder. Although the nerve block provides     extremely effective analgesia for the first 6-8 hours, patients experience severe pain once     its effect has regressed. This study will assess whether a single dose of oral hydromorphone     controlled release, given to overlap the waning of the ISB, will improve postoperative pain     control and reduce the incidence of rebound pain.      Seventy patients undergoing rotator cuff repair will receive standardized ISB and general     anesthesia for the surgery. Six hours after ISB, the patients will randomly receive either a     single oral dose of 2 mg Hydromorphone (immediate release formulation) or placebo. The     patient will be then discharged home with a prescription for multimodal analgesia, which is     the standard of care. Patients will be given a diary to record their pain scores and track     use of analgesic medications for 24 hours. Twenty-four hours after the ISB, the patients will     receive a phone call from a nurse as per the standard of care. During this phone call,     questions will be asked about their pain control.      If a single dose of pre-emptive hydromorphone is demonstrated to be safe and effective, it     will lead to change in practice of how we manage pain after rotator cuff repair. Furthermore,     the finding of this study may apply to similar surgical procedures (such as elbow, knee and     ankle repairs) that are associated with rebound pain when the nerve block wears off.   "
26473|NCT02939196|"     The purpose of the investigators'study was To compare 2 different diameter rigid hysteroscopy     in vaginoscopic approach regarding pain during and after the procedure.      And to evaluate patient acceptability and tolerability in order to determine the best way to     perform hysteroscopy in an outpatient setting.   "
26474|NCT02939183|"     A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in     patients with relapsed refractory multiple myeloma.   "
26475|NCT02939170|"     The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied     to delefilcon A contact lenses as measured by the incidence of ocular discomfort device     related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1     MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).   "
26476|NCT02939157|"     Assessment of pocket sized ultrasound (Vscan GE Healthcare) for diagnosing heart failure in     primary care patients, with a comprehensive cardiac ultrasound examination (Siemens Acusan     P10) performed at a specialized the eco.lab, as reference.   "
26477|NCT02939144|"     Aldosterone, the major mineralocorticoid hormone and cortisol, the major glucocorticoid     hormone are produced in the adrenal gland. Aldosterone binds intracellular mineralocorticoid     receptors (MR) in the kidney promoting urinary reabsorption of sodium and water and excretion     of potassium and hydrogen ions. Unregulated mineralocorticoid excess may, therefore, lead to     high blood pressure due to sodium and water retention and hypokalaemic alkalosis.      Blood concentrations of cortisol which has equal affinity for MR are 1000fold greater than     those of aldosterone. Therefore in order not to overwhelm MR, cortisol needs to be     inactivated before it binds MR. This is achieved by the enzyme 11-betahydroxysteroid     dehydrogenase type 2 (11ßHSD-2) in the kidney which rapidly inactivates cortisol to cortisone     (this process allows only aldosterone to bind MR). Reduced activity of 11ßHSD-2 leads to an     accumulation of cortisol which binds MR and hence has the effect of aldosterone. Reduced     activity of 11ßHSD-2 may be seen in the inherited condition of 'Apparent mineralocorticoid     excess (AME)' or in excessive liquorice ingestion. The diagnosis of AME and liquorice     toxicity is difficult due to unavailability of diagnostic urine analysis in most general     laboratories. Cortisol in the salivary glands, similarly to that in kidneys, is metabolised     by 11β-HSD2 to cortisone. It is proposed that increased salivary cortisol/cortisone ratio     could offer a simple and convenient diagnostic test for AME and liquorice toxicity and can be     used as a surrogate marker of urinary cortisol/cortisone ratio. The advantages of salivary     cortisol/cortisone include non-invasiveness making it stress free for the patient, no risk of     needle stick injury and ease of collection allowing potential home testing and posting of     samples.   "
26478|NCT02939131|"     IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate     whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R)     intervention for depression demonstrates improved depression and medical outcomes for     HIV-infected youth in the US compared to enhanced standard care (ESC).   "
26481|NCT02938338|"     The aim is      to examine the energy consumption before and after bariatric surgery. The study will     contribute to the knowledge if operations should be complemented by interventions to increase     energy expenditure, mainly by reducing sedentary.      as input for the design of an intervention to reduce sedentary. Such intervention should be     based on knowledge of the mediators of physical activity among the subjects that need to be     strengthened.   "
49898|NCT02632604|"     The purpose of this study is to investigate the effect of a neuroplasticity-based     computerized cognitive training for the elderly   "
26482|NCT02938325|"     General anesthesia (GA) is the process of induction of unconsciousness in order to undergo     surgery. Unlike sleep, a process of anesthesia is not related at all, 'Sleep' and does not     include dreams - but is done by using drugs that cause a kind of unconsciousness control.      The induction of GA includes combination of drugs - for sleep (inhalation anesthesia or     hypnotic drugs intravenously), analgesia (opiates) and muscle relaxants. Since most of our     patients paralyzed during surgery, the anesthesiologists have no way of knowing whether our     paralyzed patient is asleep or awake. If the patient is awake and paralyzed, a situation     named awareness under anesthesia it can cause him a traumatic experience that would leave     him a cripple for his whole life.      There are many stories about patients who lay paralyzed, awake, while been operated, who     remembered every word of what happened during the operation and of course could not mark the     anesthetist that they are awake. The anesthesiologist might suspect that his patient is awake     and paralyzed through signals from the sympathetic nervous system - for example the     increase in heart rate and blood pressure. But many of our patients receive different     medications (eg, beta-receptor blockers that does not allow the rise of a pulse) obscuring     the clinical signs, so that the patient is awake and paralyzed without being noticed by the     anesthesiologist.      Some patients are at a higher risk to suffer from awareness under anesthesia, because the     anesthesiologist cannot provide enough anesthesia, due to their medical condition, for     example: women in caesarean section under GA, patients in cardiac surgery or injured trauma     patients.      Twenty years ago, an EEG based tool, naming BIS was developed. Nowadays, BIS monitor's     credibility is questionable 1. The effect of different hypnotic drugs is not uniform. 2.     Recently it was shown that a paralyzed patient BIS index could fall mimicking a situation of     a sleep - enabling a paralyzed patient being awake. Thus, it is not clear whether the     calculation of the BIS monitor is based on physiological models that define what is     consciousness, loss of consciousness and how consciousness arises. It seems that the BIS is     only suitable for certain drugs - not as a general monitor for the level of anesthesia.      The purpose of the present study is to develop a universal system for determining awareness     under GA using an innovative algorithm for analyzing EEG waves, based on the physiological     processes of attention and perception underlying the basis for sedation and GA.   "
26483|NCT02938312|"     This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state).     Approximately 400 overweight or obese African American women living in the selected counties     will participate in a 2-year weight loss study.   "
26484|NCT02938299|"     Phase III, open-label, randomized, controlled multi-center study. In the study, 214 patients     will be enrolled and parallel assigned (via randomization system) in a 1:1 fashion to one of     two different arms.   "
26485|NCT02938286|"     The purpose of this study is to compare the effect of pretreatment with two different     ablative laser modalities, a CO2 laser and an Er:YAG laser, and to assess the role of laser     density in fractional laser assisted topical anesthesia.   "
26486|NCT02938273|"     This is an open-label phase IB trial with Bioimmunoradiotherapy, i.e. concurrent radiotherapy     with intravenous administration of cetuximab and avelumab followed by avelumab maintenance     therapy in patients with locally advanced head and neck cancer, unfit for cisplatin.   "
26487|NCT02938260|"     Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all     hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of     those presenting to the ED with AF are admitted. There are also numerous reasons for patients     to get AF with rapid ventricular rate (AF RVR) during hospitalization. In the acute setting     these patients are often treated with diltiazem, a non-dihydropyridine calcium channel     blocker (ND CCB), or metoprolol, a beta blocker (BB). Non-dihydropyridine calcium channel     blocker (diltiazem and verapamil) use is considered harmful and national guidelines recommend     against use in patients with decompensated heart failure (HF). This recommendation is based     on studies with long-term treatment. The purpose of this study is to assess the difference     between metoprolol and diltiazem for the acute treatment of AF RVR in patients with HF with     reduced ejection fraction (HFrEF).   "
26488|NCT02938247|"     The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and     use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people   "
26489|NCT02938234|"     The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and     use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people   "
26490|NCT02939118|"     The purpose of this trial is to evaluate the long-term safety in subjects previously     implanted with VC-01™ combination product.   "
26491|NCT02939105|"     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum     applicators for non-invasive subcutaneous fat reduction of the upper arms.   "
26492|NCT02939092|"     To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and     chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a     group of Egyptian children with permanent dentition.   "
26493|NCT02939079|"     This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in     patients with Relapsing-Remitting Multiple Sclerosis.   "
26494|NCT02939066|"     Current modalities for lymph node staging in cancer can be limited. Needle-based confocal     laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the     19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time     in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to     evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of     endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign     and malignant lymph nodes.   "
26495|NCT02939053|"     This study aims to establish the degree to which change in the ratio of ECF to TBW measured     using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured     using the CardioMEMS HF System (St. Jude Medical).   "
26507|NCT02938897|"     This study is a 12-week pilot randomized controlled trial to test the feasibility and     effectiveness of a home telenutrition weight loss program in men in West Virginia.   "
26508|NCT02938884|"     The primary objective of this study would be to determine whether utilization of this     technology improves adherence to recommended increases in hydration for stone forming     patients with low urine volume relative to standard techniques such as education and reading     materials. We hypothesize that the addition and utilization of the smart water bottle to     standard recommendations will lead to measurable increases 24 hour urine output for affected     patients.   "
26496|NCT02939040|"     This study is to assess the feasibility of using a positive activities intervention, Positive     Piggy Bank, in newly diagnosed women with breast cancer who will soon undergo surgery. A     randomized controlled pilot trial of a brief self-guided positive activities intervention,     The Positive Piggy Bank (PPB), compared to Treatment as Usual. The PPB intervention involves     noting at least one positive event each day, writing it down on a slip of paper and then     depositing this piece of paper in a piggy bank. This practice is to take place at the end of     the day, every day over a circumscribed period of time. At the end of the deposit period,     in the case of this study after approximately 21 days, the participant closes the account     and makes a full withdrawal by taking all of the slips out of the piggy bank and reading each     one on the night before surgery.   "
26510|NCT02938858|"     The registry aims to compare the two first-line available treatment approaches in     non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in     terms of practitioner's choice between the two options, clinical effectiveness and     cost-effectiveness, long-term outcome, and short- and long-term toxic effects.   "
26497|NCT02939027|"     Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the     treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the     treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for     the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be     the best treatment option. Location of the tumour in cosmetically sensitive areas, patient     comorbidities, old age, use of anti-coagulation etc. might all be reasons to select     radiotherapy as first choice of treatment. The objective of ths study will be to determine     histologically confirmed clinical efficacy, safety, and usability of Electronic     Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).   "
26498|NCT02939014|"     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of     brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+     Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).   "
26499|NCT02939001|"     This study included patients who visit for refractive surgery (photorefractive keratectomy,     photorefractive keratectomy with with corneal collagen cross linking, laser in situ     keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation     (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined     whether iris recognition scanner of smartphone works before and after surgery. In addition,     before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris     recognition scanner of smartphone works well.   "
26500|NCT02938988|"     The aim of this study was to evaluate the effectiveness of antimicrobial photodynamic therapy     as an adjuvant of scaling and root planning for treatment of periodontal disease in patients     with Down's Syndrome. After scaling and root planning, half of patients received     antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were     repeated after 3, 7 and 14 days. The other half received only scaling and root planning.   "
26501|NCT02938975|"     Purpose      While there is strong evidence that permethrin treated clothing prevents insect bites there     is insufficient evidence from trials to demonstrate a reduction in infections. The evidence     that topical insect repellants prevent malaria is more robust, but studies in civilian suffer     from poor compliance. It is not known if there is an added benefit from combining the two.     The effectiveness of permethrin-treated uniforms with and without DEET lotion are compared in     a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga region.      The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU)     and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group receiving     PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat uniform     (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and placebo     lotion. Both participants and investigators will be blinded to treatment allocation.      The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by     Polymerase Chain Reaction every month by active case detection.   "
26502|NCT02938962|"     The objective of this study is to evaluate and compare the effects of intravenous and topical     administration of tranexamic acid during revision hip arthroplasty on blood loss, allogenic     blood transfusion rates, length of hospital stay and perioperative complications.   "
26503|NCT02938949|"     Phase IV investigator initiated clinical trial to study the effectiveness of alirocumab, an     inhibitor of proprotein convertase subtilisin/kexin (PCSK9), versus placebo added to     high-intensity statin (atorvastatin 80 mg) in lowering low density lipoprotein (LDL)     cholesterol during non-ST segment elevation myocardial infarction (NSTEMI).   "
26504|NCT02938936|"     Our study's principle purpose is to determine whether decreasing waiting time before being     seen for antenatal care increases demand for and use of antenatal care services in     Mozambique.   "
26505|NCT02938923|"     This study is a randomized, controlled multi-center clinical trial comparing the effects of     six months of testosterone replacement therapy, with and without supervised exercise     training, in frail elderly female hip fracture patients. One third of the participants will     receive topical testosterone therapy and a supervised exercise training program; one third     will receive topical placebo gel and a supervised exercise training program; one third will     receive topical placebo gel and a home exercise program.   "
26506|NCT02938910|"     Animal models have demonstrated the role of aldosterone in left ventricular remodeling     involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for     serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease. It     is accepted that patients with primary aldosteronism have a higher prevalence of LV     hypertrophy , arterial involvement and increased cardiovascular risk. In humans, a link has     been demonstrated between aldosterone and heart failure as well as the benefit of the     administration of an anti -aldosterone drug to lower mortality in this population ,     regardless of blood pressure level . The administration of spironolactone ( aldosterone ) in     hypertensive rats has prevented the occurrence of aortic fibrosis . Plasma aldosteronism in     humans has been associated with inflammation, fibrosis and aortic stiffness . However,     primary aldosteronism is generally associated with so-called secondary hypertension . Chronic     hypertension alone is a recognized etiological factor of myocardial hypertrophy ( myocardial     fibrosis very advanced ) . The purpose of this study is to investigate the effects of MRI     hyperaldosteronism on the heart.   "
26511|NCT02938845|"     The purpose of this study was to identify factors that may contribute to anxiety of patients     undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before     and after the operation. Thus, we aimed to learn whether anxiety levels change according to     the type of hysterectomy.   "
26512|NCT02938832|"     This is a multi-centre, open, randomised study in patients treated for ischemic heart disease     in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are     treated at the cardiac rehabilitation units will be consecutively recruited during three     years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with     an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet     with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to     participate and provided with written information about the study when they are discharged     from the hospital after treatment for ischemic heart disease. The decision to participate or     not will be given at the following outpatient treatment at the cardiac rehabilitation unit.     When the signed informed consent to participate in the study has been provided, the patient     will be randomised to advice of either of the two dietary regimes.   "
26513|NCT02938819|"     Upper-limb disorders in patients with Parkinson's disease include decreased speed and     amplitude of movements, difficulty in sequential tasks, and disrupted execution of fine     manipulative hand activities.The aim of the study was to evaluate the effects of home-based     goal-oriented upper limb intervention in patients with Parkinson's disease.   "
26514|NCT02938806|"     This study employs a cross-sectional design to profile the gut microbiome and urine     metabolome in overweight/obese children with type 1 diabetes (T1D).   "
26515|NCT02938793|"     This is an investigator initiated single institution, open-label study to evaluate the     antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab     in subjects with select advanced rare solid tumors.   "
26516|NCT02938780|"     Preventing or reducing obesity is one factor that has been hailed as a way to improve quality     of life, reduce recurrence, and increase survival rates among breast cancer survivors. An     experienced team of multi-disciplinary researchers has developed an innovative and unique     approach to encourage enhanced nutrition and exercise behaviors in this population using     principles of behavioral economics. In particular, the use of social norms or exemplars has     been shown in other applications to be effective, and if successful in this population could     be inexpensively scaled up for widespread adoption. The proposed pilot study develops a     system of text messages for social/mobile media that will provide ongoing reinforcement of     desired behavior in breast cancer survivors. These messages would focus on achieving     compliance with the expert-developed nutrition and exercise recommendations of the American     Cancer Society. In the main study, 310 breast cancer survivors will be randomly placed in     intervention and control groups for the 12 week study. Behavior change will be measured using     established measures of self-reported behavior. In a sub-study, 60 of the breast cancer     survivor participants will also provide blood and urine samples so changes in biomarkers can     be assessed. The impact of the study will be measured by biomarkers and self-reported survey     responses.   "
26517|NCT02938767|"     Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of     this study is the long-term prognostic values of carotid intima-media thickness and coronary     flow reserve in cardiovascular mortality of peritoneal dialysis patients.   "
26518|NCT02938754|"     In this study the investigators evaluate the effectivity of Virtual Reality-based     rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.   "
26519|NCT02938741|"     ATG based conditioning regimen in HLA related allogeneic hematopoietic stem cell     transplantation for aggressive T-cell tumors: multi-center, open, randomized controlled     clinical study   "
26520|NCT02938728|"     Melanoma is the most aggressive skin cancer. Major advances in metastatic melanoma treatment     emerge from new immunotherapies that target specific immune inhibitory checkpoint receptors,     mainly PD1 and CTLA-4, and overcome the exhaustion state of T cells. In this context,     checkpoint inhibitors, such as Ipilimumab (anti-CTLA-4 monoclonal antibodies, mAb) and     Nivolumab or Pembrolizumab (anti-PD1 mAb), have demonstrated survival benefit in advanced     melanoma patients. Anti-PD1 agents and combination of anti-PD1 and anti CTLA-4 have now been     approved as first line therapy in melanoma. However, the predictive factors of response to     these immunotherapies remain so far elusive. Recent studies provided consistent evidence that     the immune infiltration could be tested as a biomarker for such immunotherapies. Moreover,     the very recent concept of tumor neoantigens as biomarkers of response to anti-CTLA-4 mAb,     and potentially also to anti-PD1 or combination therapies, is promising but needs to be     further explored.      In this context, the aim of our program is to identify and validate an immune signature     predictive of anti-PD-1 benefit in the treatment of advanced melanoma patients. To this aim,     tumor samples from 120 melanoma patients enrolled prospectively, treated with anti-PD1 mAb     alone or combined with anti CTLA4, will be collected as well as the corresponding peripheral     blood mononuclear cells (PBMC). Tumor infiltration with immune cells will be characterized on     paraffin embedded melanoma samples. The investigators will also perform whole-exome     sequencing on tumors and matched PBMC samples. Our primary objective is to develop a combined     immuno-signature based on an immuno-score (CD3, CD8, CD45RO…) to quantify the in situ immune     populations with a dedicated image analysis system combined with the simultaneous detection     of CD8-PD-1 and PD-L1 by immunofluorescence in baseline tumor samples. This will permit to     predict 1-year survival of patients with advanced melanoma treated with anti-PD1 and transfer     in patient's care.      Our secondary objectives are: 1/ To assess the interest of the detection of tissue-resident     memory (TRM) T cells (CD8-CD103) as a predictive biomarker of response and survival at     1-year; 2/ To extend the panel of neoantigens published by Snyder et al to other neoantigens     using a next-generation sequencing (NGS) approach on tumor samples obtained before therapy;     3/ To establish the prognostic value of this panel of neoantigens to predict tumor response     to anti-PD1 and 1-year survival; 4/ To functionally validate the identified tumor neoantigens     by stimulating patient PBMC with neoantigen peptides and measuring tumor-specific T-cell     reactivity; 5/ To define the best marker and/or the best combination of markers predicting     the overall response rate and the survival at 12 and 18 months; 6/ To attempt to establish a     correlation between immuno-signature and neoepitopes and 7/ To transfer this immune signature     in routine basis if validated.      Thus, our project will integrate two complementary strategies to define a robust and reliable     score system for predicting anti-PD1 targeting immunotherapy response. This study will     provide a unique opportunity to validate various putative biomarkers in an integrated way     that could help in determining the respective value of each isolated parameter and     potentially lead to the definition of a composite biomarker. The identified immune signature     would be of major interest in the field of cancer immunotherapy in order to select and manage     patient treatment, and to consider the benefice or toxicities expected. It will also help to     identify new target antigens of effective antitumoral immune responses and to understand the     resistance mechanisms established by the tumor and its influence on the response to current     immunotherapies.   "
26521|NCT02938715|"     In this study, subjects who are attending the dermatology clinic and who have already been     prescribed topical 5-fluorouracial for the treatment of actinic keratoses as part of their     standard of care will be recruited. The purpose of the study is to assess patient     satisfaction when engaging in follow up treatment of actinic keratosis via the     HIPAA-compliant teledermatology platform called Klara. Additionally, the goal is to assess     the difference in total duration of treatment between treatment and control group. A total of     50 subjects will be enrolled and will be randomly assigned into the treatment group     (teledermatology group; n=25) or control group (telephone only group; n=25).   "
26522|NCT02938702|"     The study is a multi-center prospective cohort study of active surveillance in papillary     thyroid cancer with low risk. The purpose of the study is to observe natural course of low     risk papillary thyroid cancer in Korean population, and comparison of prognosis between     active surveillance group and conventional surgery group. Patient will be well informed about     their choice of active surveillance or surgery.   "
26523|NCT02938689|"     This study is to compare the efficacy of exercises based on the lumbar extension and flexion     on the pain relief and the prevention of pain recurrence in chronic low back pain patients.   "
26524|NCT02938676|"     Any member of the research team conducted screening for the selection of eligible patients.     Nurses will be responsible for delivering the Guide tips for the person with a transplanted     heart, thus initiating an individualized education program. Education will be held at the     time of admission in which the patient has passed the most critical post-operative.      Educational tips guide contains all the information necessary for the patient to have a first     contact on the habits that must change. Education lasts 10-30 minutes and is taught in     daytime, in a calm environment and at the right time, favoring the presence of the caregiver.     Later, education is reinforced on the doubts that arise both the patient and the primary     caregiver.      During the first days of admission to the unit of cardiology, socio-demographic data of the     patient and primary caregiver by the research team will be collected.      A few days before discharge, having left time between 7-8 days after delivery of educational     advice guide, any member of the research team, who does not work in the cardiology unit, will     provide the patient and the primary caregiver the satisfaction questionnaire where the     perception of information and education received during the postoperative period in the     inpatient cardiology unit and the appropriateness of the topics covered in the guide     educational advice.   "
26525|NCT02938663|"     The overall goal of this study is to examine the relationships between cultural identity and     identity-based motivation, physical activity, diet and obesity risk in African-American     adolescents. It was hypothesized that African-American youth who self-report a bicultural     identity maintain health promotion beliefs and behaviors that reduce obesity risk compared to     minority youth who only identify with one culture or neither culture. It was also     hypothesized that African-American youth who self report a bicultural identity are more     likely to hold beliefs about health promotion behaviors that are congruent with their     cultural identity than compared to youth who only identify with one culture or neither     culture.   "
26526|NCT02938650|"     We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and     inflammatory cytokines on the skin.   "
26527|NCT02938624|"     A single arm, phase I, dose escalation trial and expansion cohort, examining the safety and     feasibility of neoadjuvant pembrolizumab treatment for early resectable NSCLC patients.      Hypothesis: The investigators hypothesize that response rate to neo-adjuvant pembrolizumab     will be higher than the response rate of advanced NSCLC patients.   "
26528|NCT02938611|"     The main objective of this study is to evaluate the feasibility of estimating the prevalence     of stage 4 and 5 chronic kidney disease in the Gard department of France from data obtained     via laboratory databases. To verifiy if the demand for care thus authenticated by laboratory     tests is adapted to nephrology care delivery, as recommended by the French High Authority of     Health (HAS), laboratory data will be compared with those of patients seen by nephrologists     in the department.   "
26529|NCT02938598|"     Mothers with symptoms suggesting clinical depression can be identified and potentially     motivated to seek further care during pediatric visits for their young children. The best     ways for pediatric providers to encourage mothers to seek further evaluation and treatment     for their depressive symptoms are not known. The investigators plan to provisionally optimize     a pediatric office-based intervention that we developed to motivate mothers who may be     depressed to seek further care and, thereby to improve the well-being of women from diverse     backgrounds and their children.   "
26531|NCT02938572|"     Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of     NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus   "
26532|NCT02938559|"     The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether     the Memory Support Intervention improves illness course and functional outcomes in major     depressive disorder (MDD) and cognitive therapy (CT).   "
26533|NCT02938546|"     The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after     cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of     18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial     platform of molecular classification and molecular imaging for cancer chemotherapy     assessment.   "
26534|NCT02938533|"     Interventions incorporating constructs from behavioral economics and psychology have the     potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this     hypothesis, the investigators evaluated a combination intervention to improve antiretroviral     therapy (ART) adherence based on the concepts of social norms and priming.   "
26535|NCT02938520|"     The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if     human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is     virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will     remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen     of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized,     open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1,     anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate     the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg     regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4     weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at     Screening may enroll into the study and receive DTG plus a non-abacavir containing dual     nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible particpants will enroll     into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day     1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL)     at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue     ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg     once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from     visit Week 4b until study completion or withdrawal. At the end of the Maintenance phase,     eligible participants who were randomized to continue ABC/DTG/3TC will be given an option to     switch to LA therapy at Week 100. Those participants (HIV 1 RNA <50 c/mL at Week 96) will     transition to LA dosing, beginning with approximately 4 weeks oral CAB + RPV therapy at Week     100, and receive the first IM CAB LA + RPV LA injections at Week 104b. Participants will     continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV     LA are either locally approved and commercially available, the participant no longer derives     clinical benefit, the participant meets a protocol-defined reason for discontinuation, or     until development of either CAB LA or RPV LA is terminated.   "
26536|NCT02938507|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     different formulations of orally administered solabegron in healthy male subjects.   "
26537|NCT02938494|"     Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment     of Acne Vulgaris   "
26538|NCT02938481|"     The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution     in colon cancer and provide reliable evidence regarding the optimal length of bowel resection     and the extent of central lymph node dissection in colon cancer surgery.   "
26555|NCT02938117|"     Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle wich permits     eccentric (ECC) lower limbs contractions at a defined power output. With this type of     ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the     same power output. Consequently, ECC program could be used in chronic disorders with limited     capacities, such as obesity.      The investigators hypothesis that an eccentric training program, as it will induce higher     mechanical constraints, would improve body composition, especially by reducing fat mass. This     effect could be explained by an increased rest energy expenditure and a better improvement in     biological parameters (particularly lipid profile and insulin-resistance) after ECC training     (versus CON training).      This study aims to compare the modification of fat mass after an ECC program versus a CON     program at the same VO2. The secondary goal is to assess the physiological mechanisms     involved in the modification of body composition   "
26561|NCT02938039|"     This study will guide the anesthetists regarding the appropriate selection of the LMA in     neonatal age group based on scientific basis.      This study will add up to existing literature about the safety of LMA usage in neonates and     infants. Furthermore it may shed some light on which LMA type will be more feasible and     effective for neonatal/ infants usage.   "
26539|NCT02938468|"     Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the     subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH     is believed to arise from tearing of bridging veins as a result of trauma, which may be minor     and unapparent to the patient. Management of cSDH is widely varied. A wait-and-see or     wait-and-rescan approach may be acceptable in asymptomatic patients with a relatively small     hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness     may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or     craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and     recurrence rates of 4%-33% requiring further treatment in some instances.The safety and     efficacy of different neurosurgical procedures have been evaluated but there is a paucity of     well-designed randomized controlled trials in the literature. Consequently, there is no     consensus on the best treatment with respect to surgical technique, pre-operative and     post-operative management and nonsurgical alternatives including the use of Corticosteroids,     Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE)     inhibitors.      Corticosteroids may be a therapeutic option in the management of cSDH. There is very little     data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized     trials. The purpose of the study is to prove dexamethasone can be just as efficacious as     surgery in treating chronic subdural hematoma. The investigators also hope to show that those     patients treated with dexamethasone suffer less complication compared to those who undergo     surgery.   "
26540|NCT02938455|"     In the last few years much attention has been paid to hyperalgesia induced by opioids, which     represents a clinically significant condition following acute and chronic exposure to     opioids. It has been suggested that the increase in gene expression of μ-opioid receptors and     the development of hyperalgesia could be linked to epigenetic mechanisms. In particular the     use of opioids seems to be related to an increase of the degree of DNA methylation. In the     literature are not currently available data about the degree of DNA methylation in surgical     patients, opioid-naive prior to surgery, receiving acute opioids treatment in the     perioperative period.      The primary objective of this study is to assess the degree of perioperative DNA methylation     (extracted from whole blood) in patients undergoing major surgery exposed to opioids     according to current clinical practice compared to preoperative baseline levels. The timing     (preoperative vs intraoperative vs postoperative) in which the possible increase of the     degree of DNA methylation will happen wil be assessed.      20 consecutive patients undergoing major surgery performed under general anesthesia that have     expressed their consent to participate to the study will be enrolled. This sample is adequate     to allow the observation of a possible increase of DNA methylation in opioid-naive patients     exposed to anesthesia/analgesia based on opiates according to current clinical practice.   "
26541|NCT02938442|"     The purpose of this research is to compare the effect on breast cancer of using a new     experimental breast cancer vaccine (used to stimulate immune cell production) with     chemotherapy and surgery versus the usual treatment of chemotherapy and surgery.   "
26542|NCT02938429|"     This study will be a cross sectional assessment of physical activity as measured through     accelerometers and its association with endothelial function of children with Fontan     circulation and healthy age and gender matched controls who are followed at the University of     Alberta - Stollery Children's hospital.   "
26543|NCT02938416|"     Our participants will include 40 patients within one month of stroke, 40 patients who     received total hip replacement or total knee replacement two to four weeks before. The     participants will be randomly assigned to the isokinetic training group or the isotonic     training group. Outcome measures including isometric peak torque of hip/knee at 90 degree of     flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short     Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma     concentration of hsCRP, and the level of substance P in saliva will be collected at the     beginning and 4 weeks after the training program. Statistical significant differences will be     determined between the improvement of outcome measures of the isokinetic and the isotonic     training groups.   "
26544|NCT02938403|"     This is a study to determine the efficacy of a smoking cessation intervention (nicotine     replacement therapy (NRT) and counseling) done in a systematized manner with participants     recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use     of the NRT medication during the session using specialized counseling focused around their     experience of using NRT, including how the use of NRT may help them quit smoking, side     effects, and smoking cessation expectancies. In this study those in the In Vivo group will     put the patch on during Session 1 and given nicotine gum in Session 2 and will discuss the     experience of wearing the patch or chewing the gum while they are in session. The control     group will not put on the patch or chew gum during the sessions but will be given standard     counseling regarding quitting smoking.   "
26545|NCT02938390|"     Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in     the study. US will be performed after induction of general anesthesia, prior to surgery using     Sonosite™ portable US, 5-12mHz transducer using doppler mode.   "
26546|NCT02938377|"     Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and     alcohol use Disorders (AUD) symptoms.      Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and     HIV-related outcomes.      Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions   "
26556|NCT02938104|"     The investigators propose a randomized controlled study in patients undergoing lung resection     for cancer to compare the impact of multimodal intervention composed of exercise, nutritional     supplement and psychological well-being on functional exercise capacity. One group     (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks;     the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation     group). In this case, both groups will be exposed to the program, which will be available to     both groups postoperatively. One of the two groups will start this program 4 weeks before     surgery and continue for 8 weeks postoperatively, and the other will start once they leave     the hospital and continue for 8 weeks postoperatively.   "
26557|NCT02938091|"     The investigators evaluated dietary modulation of LIPC rs1800588 (-514 C/T) for lipids and     glucose using a randomized cross-over design comparing a high-fat Western diet and a low-fat     traditional Hispanic diet in Caribbean Hispanics (n=42; 4 weeks/phase).   "
26547|NCT02938221|"     The study investigates the feasibility and safety of the telemedical implementation of three     diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing     system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and     test of skew (vertical misalignment) known as the HINTS protocol. Previously published data     have shown high sensitivity and specificity of the protocol for the discrimination of central     and peripheral causes of acute vestibular syndrome. In this study the three tests will be     executed on 30 healthy subjects using video goggles (EyeSeeCam, Interacoustics GmbH, Germany)     connected to a mobile wireless-workstation for bidirectional audiovisual communication in a     clinical environment (MEYTEC GmbH, Germany). A newly developed remote control and video     conferencing solution allows the execution and evaluation of the HINTS protocol in a     telemedical setup.      The examination is guided by a remote physician using the help of a trained assistant     attending to the subject. Corresponding clinical bedside tests will be executed for     comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical     setting. Safety as well as accuracy of the telemedical versus bedside examination will be     analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy     for patients with acute vestibular syndrome in remote areas where specialists are rare.   "
26548|NCT02938208|"     This investigation is a prospective non-blinded and non-randomized clinical investigation.     This investigation is designed to evaluate the performance (leak and comfort) as well as     participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number     of up to 15 OSA participants who currently use full face masks will be recruited for the     trial.   "
26549|NCT02938195|"     The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most     important radiation area and hope to reduce the radiation volume and try to reduce the     postoperative mortality and treatment-related mortality.   "
26550|NCT02938182|"     The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine     may concern with platelet aggregation and paradoxical embolization. The aim of the study is     to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.   "
26551|NCT02938169|"     The purpose of this study is to determine the effective exercise protocol in chronic low back     pain patients.   "
26552|NCT02938156|"     Severe haemophilia A and B (SHA, SHB) are inherited bleeding disorders affecting male     patients and are characterised by low levels of circulating clotting factors VIII and IX     respectively. Clinically low levels present with multiple recurrent bleeds into joints and     muscle from the first couple of years of life. In addition patients may present with     spontaneous and potentially fatal bleeding into any organ. The mainstay of treatment is     replacement with the missing factor in the form of intravenous injections of factor VIII and     IX. Clotting factors can be given to treat a bleed or can be given to prevent a bleed, and     the latter is termed prophylaxis. Regular prophylaxis is the current standard of care and     aims to decrease spontaneous bleeding events and resulting joint damage, and this requires     patients to self-infuse factor into their veins two to four times week. Patient's compliance     with prescribed regimen and recommendations has a significant influence on outcomes.      Advances in biomolecular and protein engineering have extended the duration of the effect of     clotting factor VIII and IX through multiple mechanisms. This extension of the duration of     the effect presents the clinician and patients with opportunities to tailor the treatment to     their particular needs, circumstances and body other characteristics. It has been suggested     that decreasing the frequency of infusions will improve adherence and thus contribute to     improved outcomes.      In rare disorders, it is an accepted fact that post-marketing studies are crucial to     understand the generalisability of the efficacy and safety outcomes and identify any new     safety and efficacy concerns in relation to specific population group. The investigators     propose the development of a registry for systematic collection of information with the dual     aim of analysing the relationship between patient and treatment characteristics, and     outcomes, and simultaneously identify areas for practice development that can improve the     overall quality of life experienced by the haemophilia patient community.   "
26553|NCT02938143|"     Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance     in jumping athletes. Exercise therapy is considered the best initial treatment option for     tendinopathies as clinical improvements in pain and function have been demonstrated. Although     painful eccentric exercise protocols have been promoted as standard care based on positive     results in early studies, a recent systematic review demonstrated that these are not     associated with improved tendon structure and are ineffective when applied in-season.     Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel     concept in sports medicine. A recent study advocates a progressive 4-stage criteria-based     exercise protocol as it results in a less reactive tendon and ability to restore collagen     alignment. This protocol consists of progressive isometric, isotonic, plyometric, and     sport-specific exercises. Isometric exercises have been shown to reduce pain and decrease     motor cortex inhibition of the quadriceps. This approach would enable jumping athletes to     resume sports within the limits of pain, with improved muscle function, and sufficient tendon     structure re-organization. The diagnostic imaging work-up of patellar tendinopathy typically     consists of ultrasound, magnetic resonance imaging (MRI), or a combination of both.     Ultrashort echo time (UTE) MRI is an advanced MRI technique, which enables assessment of     tissues with short T2-time, such as tendon, the structure of which is invisible on regular     MRI. UTE has been shown to quantitatively depict changes in tendon microstructure and     therefore allows in-vivo evaluation of tendon regeneration. It is currently unknown whether     quantitative UTE MRI parameters change after exercise treatment, are related to clinical     symptoms of patellar tendinopathy, have prognostic value for exercise treatment response, and     offer additional value over ultrasound   "
26554|NCT02938130|"     People with disabilities experience a staggering incidence of secondary conditions that can     result in death or negatively impact their health, participation in the community, and     quality of life. Many of these chronic secondary conditions are preventable. The Institute     for Healthcare Improvement has advocated for optimizing care through programs that     simultaneously improve health and the patient experience of care, while reducing cost, called     the Triple Aim. Studies have shown that the Triple Aim can be achieved through programs     that facilitate community integration; however the U.S. healthcare system lacks a paradigm of     care for individuals with disabilities that promotes community integration. In order to     identify potential models of healthcare delivery for individuals with disabilities that are     effective in achieving the Triple Aim, we will conduct a rigorous research project to     evaluate the impact of two different models of care on the Triple Aim: 1) a community-based     care management program delivered by a non-profit organization through waiver funds, and 2)     the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with     disabilities between ages 55-64.   "
26558|NCT02938078|"     The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days     and (2) the change in signs and symptoms of ocular surface disease in demodex-positive     subjects beginning the use of Avenova.   "
26559|NCT02938065|"     The proposed study will use this technology to observe emptying of the stomach of a protein     and carbohydrate rich clear liquid sports/nutrition drink.   "
26560|NCT02938052|"     The focus of this study is to examine the feasibility, acceptability, and preliminary impact     of our customized positive psychology (PP)-based health behavior intervention in a group of     patients with mild to moderate heart failure (HF).   "
26562|NCT02938026|"     Nutrition therapy is recognized as one of the crucial components for the standard treatment     of diabetes along with physical activity and drug therapy. Of note, dietary habits are     culture specific and hence understanding the dietary intake, eating behavior and physical     activity level of the local population is important to formulate effective nutrition and     lifestyle strategies. Weight control is a major therapeutic challenge because many     conventionally used anti-diabetic agents, such as sulphonylurea and insulin, can cause weight     gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing     levels of free fatty acids from adipose tissues . Although intensive face-to-face lifestyle     intervention program has showed that even modest weight loss in people with Type 2 diabetes     (T2DM) who were overweight or obese was associated with improvements in glycemic control and     associated conditions, it may not be feasible in public hospital setting in Hong Kong due to     factors such as limited resources, scheduling, patient's employment and willingness for     frequent travel to the clinic. Hence, alternative strategies such as a combination of face-     to-face individual dietary and lifestyle consultation together with telephone intensive     lifestyle reinforcement program will likely to be an useful strategy to engage those obese     T2DM patients through frequent individual contacts. On the other hand, bariatric surgery has     emerged as an impressive therapeutic option for poorly control obese T2DM patients.      Realizing there is a knowledge gap in understanding the lifestyle factors in the Hong Kong     Chinese obese T2DM patients, we therefore propose to conduct a 1-year prospective clinical     trial with two main objectives:        1. To study and compare the glycemic and weight improvement after bariatric surgery versus          a telephone intensive lifestyle intervention program for 1 year in Hong Kong Chinese          obese patients with type 2 diabetes.        2. To investigate the effect of lifestyle factors including dietary intake, eating          behaviors and physical activity level on the glycemic and weight control of Hong Kong          Chinese obese patients with type 2 diabetes.   "
26563|NCT02938013|"     Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus     (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three     (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)   "
26564|NCT02938000|"     This pilot study intends to evaluate an online exercise video rehabilitation program for     stroke survivors with moderate disability compared to usual care. The intervention videos     combine aerobic and resistance training using a latex resistance band, Thera band® elastic     band, specifically designed for rehabilitation. This study will aim to show that for patients     suffering acute ischemic stroke resulting in disability, at-home physical therapy with     aerobic exercise videos will improve depression level and aerobic capacity more than usual     care.   "
26565|NCT02937987|"     The objective of this study is to describe and examine the dietary intake, eating behavior     and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association     with weight and glycemic control at baseline and 1 year follow-up. The investigators     hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern     and low physical activity level are associated with poorer glycemic and weight control, and     there will be no improvement with weight and glycemic control under usual care after 1 year.   "
26566|NCT02937974|"     Objective: A prospective multicenter randomized controlled trial to assess the efficacy and     safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary     disease(AECOPD).      Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They     will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing     injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the     agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12     hours. administration of the agent for consecutive 5 days. Compare the following index     between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg     cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.   "
26567|NCT02937961|"     Consecutive patients with cirrhosis and septic shock with AKI who give written informed     consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will     be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be     stored. Septic shock will be defined by the presence of two or more diagnostic criteria for     the systemic inflammatory response syndrome, proven or suspected infection with hypotension     non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume     variation on flow track and need of a vasopressor to achieve a target mean arterial pressure     (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also     be done. Patients with age less than 18 years, severe known cardiopulmonary disease     (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic     kidney disease on hemodialysis, patients already meeting emergency criteria for immediate     hemodialysis at the time of randomization as specified in the late group, patients     transferred from other hospitals who have already been on hemodialysis before their arrival     in the intensive care unit, extremely moribund patients with an expected life expectancy of     less than 24 hours, failure to give informed consent from family members.   "
26568|NCT02937948|"     This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in     the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and     gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative     IMRT strategy.   "
26579|NCT02937805|"     Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen.     Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of     intimate area. The objective of this study is to investigate the effects of a non-hormonal     moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.   "
26580|NCT02937792|"     To test the safety of high dose spinal in elective CS after prolonged sitting position.   "
26593|NCT02937610|"     PEG tubes are commonly used to provide nutritional support to patients with head and neck     cancer. PEG insertions are typically carried out by gastroenterologists, but also     otorhinolaryngologist - head and neck surgeons perform the procedure in some countries.     Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The     investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG     tube insertions, and analyze the time gains and cost effectiveness achieved of the     independency from other specialities.   "
26630|NCT02937129|"     The primary aim of this study was to determine the accuracy of an infrared thermometer     compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare     tympanic and axillary temperature measurements by evaluating agreement and correlation to     determine whether an infrared tympanic thermometer can replace an axillary mercury     thermometer in the emergency department.   "
26657|NCT02936778|"     This study will prospectively assess the impact and relevance of several risk factors for     children with severe acute asthma (SAA) or acute wheeze that have been identified in     retrospective studies. Secondary we will assess short-term medical and psychosocial     functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control     group admitted to a MC for SAA/acute wheeze.   "
26569|NCT02937935|"     Intervention: All patients at presentation would be assessed for the underlying cause of and     will be managed by removal of all precipitants(careful review of medications, diuretics,     nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step     would be to consider plasma volume expansion in patients with hypovolemia (the choice of     fluid could either be a crystalloid or albumin or even blood as indicated) along with     identification and early treatment of bacterial infections. Along with this patients with a     differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide     midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis of     ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further,     patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid     resuscitation and vasoconstrictors would also be subjected to randomization.        1. In the on-demand group patients would get dialysis only when patient fulfills absolute          criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia,          refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of          less than 0.5ml/kg for more than 24-48 hours from the time of randomization        2. In the protocol guided group patients all patients would be considered for dialysis          within 6 hours of randomization After randomization patients would receive dialysis as          three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate          flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration          and/or diffusion in continuous form until recovery of renal functions   "
26570|NCT02937922|"     Introduction: Endothelial dysfunction precedes atherosclerosis being evidenced in patients     with hypertension. Increasing physical activity levels and/or physical exercise are part of     the recommendations of antihypertensive therapy. However, the effects of oscillations and/or     increase the systemic blood pressure induced by exercise session on endothelial function has     not been studied.      Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined     exercise on endothelial injury levels in patients with hypertension.      Methodology: Hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will     perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40 minutes     of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of one     repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20 minutes     of resistance exercise and 20 minutes of aerobic exercise, in that order). Blood will be     collected 10 minutes before, 10 and 60 minutes after intervention for the quantification of     endothelial microparticles (MPE) circulating (induced endothelial lesion) and endothelial     progenitor cells (EPC) circulating (endothelial recovery capacity) by flow cytometry.     Ambulatory blood pressure monitoring (ABPM) will be held before and after the intervention.     Ultrasonography is used to measure the flow-mediated dilation of the brachial artery 10     minutes before, 10, 30 and 60 minutes after the intervention.      Statistics: generalized estimating equation (GEE) for repeated measurements and Person     correlation, being significant p < 0.05.      It is expected to show results to ensure cardiovascular protection in patients with     hypertension caused by different types of exercise and consequent endothelial injury and     release induced regenerative factors. Knowledge of the magnitude of injury and endothelial     recovery provided by different types of exercise can contribute scientifically to health     professionals aimed at prescribing exercise with a vascular protective vision in patients     with hypertension.   "
26571|NCT02937909|"     This study is designed to investigate whether the adoption of the use of a range of wound     care products from a single manufacturer makes training in appropriate product selection more     effective and results in more accurate selection of the appropriate product for the wound and     for the patient's lifestyle, thereby incurring less waste and reducing the number of     referrals by the community nursing team to the Tissue Viability Team.      One community nursing team will switch to using a full range of dressings and compression     products from BSN medical UK for three months. Nurse training on the products will be given     and nurse competencies and confidence in woundcare and appropriate product selection will be     tested at the start and end of the study.      The number and type of referrals to the Tissue Viability Team will be measured.      Total anonymised data on numbers of referrals, wound closure, numbers of wounds and quantity     and cost of products used will be collected and compared with the historical record for three     months prior to the study. Patients will complete a Quality of Life questionnaire at     enrolment and exit from the study.      Patients for whom BSN medical UK products are not appropriate or not desired by the patient     will not be enrolled and will receive the usual range of products available to the community     nursing team.   "
26572|NCT02937896|"     The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal     desmopressin in renal colic patients pain control.   "
26573|NCT02937883|"     The purpose of this study is to evaluate the effects of an empowerment intervention for     community-dwelling persons with young onset dementia and their informal caregivers.   "
26574|NCT02937870|"     The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite     force study will be to compare bite force measurements over a 12 hour period across two     (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive     control), and a negative/no treatment control.   "
26575|NCT02937857|"     This is a multicenter, randomized, open Label,add-on study.   "
26576|NCT02937844|"     CAR T cell immunotherapy has achieved great success in CD19+ B-cell malignancies. Whether     this new generation of cell-based immunotherapy can be applied to solid tumors remain to be     investigated, partly due to hostile immune-suppressive tumor microenvironment which favors     tumor growth but not immune system. Signaling pathway of programmed death 1 (PD-1) and its     ligand PD-L1 plays an important role in suppressing immune response against tumors. PD-L1 is     over-expressed in 88% of glioblastoma.      We constructed a chimeric switch receptor (CSR) containing the extracellular domain of PD1     fused to the transmembrane and cytoplasmic domain of the costimulatory molecule CD28. CSR     modified T cells are able to recognize PD-L1-expressing tumor cells and transduce signals to     activate T cells, which results in tumor killing. A truncated EGFR (tEGFR) which lacks of the     ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the     CSR vector and is used for in vivo tracking and ablation of CSR T cells when necessary. This     pilot study is to determine the safety and efficacy of autologous CSR T cells in patients     with recurrent glioblastoma.   "
26577|NCT02937831|"     The purpose of this survey is to understand the following items observed in the actual     clinical use of RIXUBIS.        1. Unexpected adverse drug reactions        2. Occurrence of adverse drug reactions in the actual clinical use        3. Factors that may affect safety and effectiveness        4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX          deficiency        5. Safety and effectiveness for hemophilia B patients who received routine prophylactic          therapy, on-demand therapy and perioperative therapy   "
26578|NCT02937818|"     Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm,     signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who     have refractory or resistant disease from prior platinum-based chemotherapy.   "
26581|NCT02937779|"     The World Health Organization recommends that all high endemic countries for HBV infection     based their mother to child transmission prevention strategies on vaccination of all children     and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first     24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results     in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15%     of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high     levels of HBV replication occurring in the third quarter of pregnancy act as a major risk     factor.      The objective of this study is to assess the effectiveness of an operational strategy to     prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests     HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive     HBeAg test with a test and treat strategy for those seen for Antenatal Care (ANC) from 24     weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according     to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of     age.      A phase IV multicenter observational and interventional non randomized prospective study will     be conducted in 4 maternity in Cambodia.      The primary outcome will be the proportion of active HBV infection in new-born at 6 months of     life estimated by HBs Ag positivity.      The study will aim to document the acceptability and the operational implementation of the     study using rapid tests usable in all health centers and a drug available in all the country     thanks to HIV national program. The results will be helpful for Cambodian government in order     to implement guidelines and algorithm follow-up for HBV-infected pregnant women.   "
26582|NCT02937766|"     To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered     subcutaneously via auto-injector is associated with less pain as compared to intramuscular     injections of Makena®   "
26583|NCT02937740|"     Multicenter study consisting of two study periods as follows: a 90-day Treatment Period, with     potential extension by 30 days for those patients requiring a dose increase, as determined by     the treating physician. Participants receiving 122.5mg of NATESTO (5.5 mg of testosterone)     per nostril twice daily may have an increased daily dose adjustment on Day 90, based on their     hypogonadism symptoms.   "
26584|NCT02937727|"     Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's     disease (PD), but it is not optimally effective for controlling every motor sign and adverse     events are not so infrequent. Therefore,other approaches should be considered. New Approaches     in MRI at 3T and long-term local field potential (LFP) recording are very important to target     subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study     aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep     brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals:     1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term     clinical and electrophysiology effects of deep brain stimulation on STN.   "
26585|NCT02937714|"     Significantly higher prevalence of emotional and behavioural problems have been reported from     Pakistan.This higher prevalence along with stigma of psychiatric problems and limited child &     adolescent mental health services in Pakistan means that it is important to consider     alternate methods for promoting psychological and emotional well-being of our youth. Schools     can thus act as a natural platform for mental health promotion as schools context has almost     as much impact on students' emotional health as the family context.      Teachers' role in the school mental health initiatives cannot be overemphasized. Teachers own     knowledge and beliefs regarding mental health influence the way they respond to students     mental health crisis. Recognizing the need for wider implementation of evidence based school     mental health interventions in the region and to help in addressing the mental health     literacy of educators in resource constrained settings, World Health Organization, Eastern     Mediterranean Region (WHO-EMRO) has developed a concise and practical manual of school mental     health in December 2014. In the absence of any whole school approach study from Pakistan     focusing on teachers training and addressing all the various evidence based components of     promotion of positive mental health, Investigators aim to conduct a pilot randomized     controlled trial to assess effectiveness of training based on WHO-EMRO manual, in addition to     its feasibility & acceptability in improving teachers' mental health literacy and     self-efficacy in dealing with students mental health issues.      HYPOTHESIS:      For teachers:        -  School mental health training intervention will significantly improve teacher's mental          health literacy & self-efficacy compared to wait list control group.        -  At 3 months follow-up, control group teachers' mental health literacy will also improve          compared to baseline due to contamination of information provided, across groups within          the same school.      All hypothesis pertains to individual level.      For students:      Mental health training of teachers would lead to an overall improvement in student's outcome     measure (student's emotional and behavioural difficulties) at 3 months follow-up.   "
26586|NCT02937701|"     This trial is designed to determine what effects the human body has on the investigational     medicine, ABP 710, and what effects the body has on the investigational medicine after you     have been given it, and if this is comparable to what is seen for the licensed medicine,     infliximab, in patients with moderate or severe rheumatoid arthritis (RA).      This study will assess if the investigational medicine is safe and effective in      treating moderate or severe RA compared to the licensed medicine.   "
26588|NCT02937675|"     This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and     cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and     antitumor activity of eFT508. The study will evaluate oral daily administration of eFT508.     Treatment and study subject evaluation will be performed in 21-day cycles.   "
26589|NCT02937662|"     In this multi-center, randomized, open-label, prospective clinical trial, a total of 60     relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm,     patients receive IAC regimen. In the control arm, patients receive other physician-directed     regimen. The primary end point is complete remission rate.   "
26590|NCT02937649|"     Staple-line leak is the most frequent and incapacitating complication after laparoscopic     sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the     staple-line leak rate after LSG according to the use of a bougie calibre of 36 or 48-Fr,     assuming that a higher diameter is correlated with a lower risk of leak, without lowering     long-term weight loss.   "
26591|NCT02937636|"     This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group     clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice     compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs     of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12     weeks use in a Chinese population.   "
26592|NCT02937623|"     A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment     group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in     relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after     application compared to no treatment.   "
26594|NCT02937597|"     Objective:      To determine the effectiveness of proficiency based inter-professional communication training     in an online environment on medical student's use of the ISBAR (Identify, Situation,     Background, Assessment, Recommendation) communication escalation protocol in the     deteriorating patient      Setting: The study will be conducted in University College Cork, Ireland. Participants: Fifth     year medical students, who are scheduled to undertake ISBAR training as part of the National     Early Warning Score (NEWS) programme.      Intervention: Participants will be prospectively randomized to one of three groups for     training before undertaking a performance assessment of an ISBAR communication relevant to a     deteriorating patient in a low fidelity simulation environment: HSE group (the national     e-learning programme only); S group (national e- learning plus access to online scenarios and     facilitator when requested) and PBP group (national e-learning plus access to online     scenarios training course with in-built proficiency-based progression, and facilitator when     requested).      Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication     in the context of an acutely deteriorating patient.   "
26595|NCT02937584|"     To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID)     and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and     resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD)     following chronic dosing after approximately two weeks treatment.   "
26596|NCT02937571|"     The purpose of this study is to test whether giving high doses of carfilzomib along with the     other drugs (lenalidomide and dexamethasone) is safe and which dose is best tolerated by     patients. In addition, the study is designed to test the amount of remaining myeloma cells in     the body after treatment with higher carfilzomib doses which is known as minimal residual     disease (MRD).   "
26597|NCT02937558|"     This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with     open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a     continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose     infusion rates in children < 1 year of age with congenital hyperinsulinism.   "
26598|NCT02937545|"     This study aims to compare patient use of and satisfaction with community     pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a medication     therapy management (MTM) service. Pharmacist and patient outcome measures will be collected     by surveys, interviews, and review of pharmacy records.   "
26599|NCT02937532|"     The aim of the study is to evaluate whether combining cognitive-behavioral therapy (CBT) with     task-oriented balance training (TOBT) is more effective than general health education (GHE)     together with TOBT in promoting fear of falling and reducing activity avoidance behavior.   "
26600|NCT02937519|"     1. Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and          intensity modulated radiotherapy term efficacy of the treatment of locally advanced          nasopharyngeal carcinoma.        2. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity          modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and          tolerability.      3）observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group     can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal     carcinoma provides a more reasonable way.   "
26601|NCT02937506|"     The primary purpose of this study is to determine if patient satisfaction with propofol is     better than with non-propofol anesthesia for outpatient colonoscopies.   "
26602|NCT02937493|"     A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical     University Vienna, from 01/2008 to 12/2015 have been considered eligible for inclusion. Out     of this patient population a total of 1.406 cases associated with IPV have been consecutively     and prospectively included in our in-house screening service for IPV cases. Data collection     was performed prospectively and statistical evaluation was performed retrospectively,     approved by local IRB (1453/2016).   "
26603|NCT02937480|"     The majority of people after stroke demonstrate mobility limitations, which may reduce their     physical activity levels. Task-specific training has shown to be an effective intervention to     improve mobility in individuals with stroke, however, little is known about the impact of     this intervention on levels of physical activity. The main objective will be to investigate     the efficacy of a task-specific training, focused on both upper and lower limbs, in improving     physical activity levels and mobility in individuals with stroke. The secondary objective     will be to investigate the effect of the training, in improving muscle strength, exercise     capacity, and quality of life. A randomized controlled trial with blinded assessment will     assign eligible participants to either: 1) experimental group or 2) control group.     Participants will receive interventions three times per week over 12 weeks. The experimental     group will undertake task-specific training, while the control group will undertake global     stretching and memory exercises, and health education sessions. Primary outcomes will include     measures of physical activity levels and mobility, whereas secondary outcomes will be muscle     strength, exercise capacity, and quality of life. The outcomes will be measured at baseline,     12 weeks post-intervention, and four and 12 weeks follow-up. The findings of this trial have     the potential to provide important insights regarding the effects of task-specific training,     focused on both upper and lower limbs, in preventing secondary post-stroke complications and     improving the participants' general health through changes in physical activity levels.   "
26618|NCT02937285|"     The relative effectiveness of current treatments and their different mechanisms of action     yield to consider more and more that the multiple sclerosis (MS) therapeutic approach must     use multiple molecules, both combined and sequential.      In this sense, one can assume that the combination of two molecules with different but     complementary mechanisms of action, can delay progression of the disease. Mitoxantrone has a     powerful action, immediate and total, whereas interferon a selective action, immunomodulatory     and delayed.   "
26619|NCT02937272|"     The main purpose of this study is to evaluate the safety of the study drug known as LY3200882     in participants with solid tumors.   "
26631|NCT02937116|"     The purpose of this study is to determine the safety, tolerability and efficacy of IBI308     monotherapy or in combination with chemotherapy in patients with certain types of advanced     solid tumors. Another purpose is to determine the pharmacokinetics, pharmacodynamics and     immunogenicity of IBI308   "
26604|NCT02937467|"     The incidence rates of thyroid cancers have increased in the past decade. Additionally, up to     68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules is     very important and can avoid unnecessary biopsy of benign nodules. Shear wave     elastography(SWE), a novel ultrasound-based elastographic method, is a new real-time,     quantitative, operator-independent, and reproducible technique. Briefly, shear wave     elastography uses a radiation force produced by an ultrasonic beam to stress tissues and     ultrafast sonographic tracking techniques to measure the speed of shear waves. Based on the     Young modulus formula, tissue elasticity can be derived from the shear wave propagation     speed, and a real-time color-coded elastogram can be displayed, showing softer tissue in blue     and stiffer tissue in red.      There are lots of research confirmed that SWE has a certain value in the diagnosis of thyroid     carcinoma. These studies include prospective studies and retrospective studies, but both     belong to a single center study. It has not been applied to the study of the multicenter of     thyroid disease.      The main purpose of the study is to assess the performance of SWE for identification of     benign and malignant thyroid nodules and calculate the optimal cutoff value for each     parameter in multicenter study; the secondary purpose is to evaluate the application value of     SWE for uncertain nodules by FNA.   "
26605|NCT02937454|"     Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and     Iron Deficiency (Affirm-AHF)   "
26606|NCT02937441|"     The purpose of this study is to determine cerebral edema with evaluation of measurement of     diameter of optic nerve sheath.   "
26607|NCT02937428|"     It is common for people to advise individuals undergoing vaccination to look away from the     needle to make them hurt less and be less scary. However, this advice is not backed up by     research evidence. the purpose of this study is to learn about how looking away vs. looking     at the needle during vaccination makes people feel. People will be randomized to 1 of 2     groups: look at the needle, look away. Then they will undergo vaccination and report on pain     and fear experienced.   "
26608|NCT02937415|"     Waterpipe is a tool for smoking tobacco, which is thought to be less harmful than cigarette.     Unfortunately, there aren't adequate studies about its harms to health that are threatening     the young generation all over the world today. The objective of this study was to show the     carbon monoxide (CO) levels in waterpipe smokers' breaths, whether can be used or not to     reflect the changes of oxidative stress for this reason to predict harmful effects on the     pulmonary functions.   "
26609|NCT02937402|"     This pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in     identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small     cell or small cell lung cancer. Bronchoscopy uses a thin, tube-like instrument inserted     through the nose or mouth to view the inside of the trachea, air passages, and lungs.     Bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid.     Bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers that     are more present in some cancers than others that will help determine which individuals have     a greater or lesser chance of benefiting from immunotherapy.   "
26610|NCT02937389|"     Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical     esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and     strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic     evaluation about reconstructive organs after esophagectomy. The investigators evaluate     endoscopic predictions using classifications in acute phase after esophagogastrostomy.   "
26611|NCT02937376|"     The purpose of this study is to investigate the effects of N-acetyl Cystein (NAC)     supplementation on redox status, physiological and biochemical parameters in G6PD deficient     individuals after acute exercise.   "
26612|NCT02937363|"     The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation     on redox status, physiological and biochemical parameters in G6PD deficient individuals after     acute exercise.   "
26613|NCT02937350|"     The goal of this study is to better understand vitamin D catabolism and how it is affected by     CKD and race. Specifically, the study team will evaluate the metabolic clearance of     25-hydroxyvitamin D3 in individuals with varying degrees of CKD and among participants who     self-report race as Caucasian, African American or African. The long-term goal of this work     is to enhance the clinical evaluation and treatment of impaired vitamin D metabolism.   "
26614|NCT02937337|"     In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided     laryngeal mask airway real time insertion technique with the standard recommended index     finger-guided insertion technique in pediatric patients.   "
26615|NCT02937324|"     This study compares the comparing the validity and usability of smartphone software for home     monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical     gold standard - the Unified Parkinsons Disease Rating Scale.   "
26616|NCT02937311|"     This study aimed to compare the effects of kinesiotaping, neuromuscular electric stimulation     (NMES), and neuromuscular training on pain, and motor activity and function in patients with     upper extremity hemiplegia.   "
26617|NCT02937298|"     Weight gain occurs because of imbalances in energy balance favouring energy intake. Whilst     over 50% of a person's energy requirement goes towards the maintenance of physiological     functions, around 40% is used for physical activity. In addition to this, around 10-15% of     energy is spent on what is termed as Diet Induced Thermogenesis (DIT). Diet Induced     Thermogenesis is the increase in energy expenditure following a meal, and represents the     energy utilised for the digestion and metabolism of food. Some nutrients such as proteins     require more energy to digest and therefore produce a greater DIT than others. In addition to     this, some food components are able to independently stimulate calorie burning. For example     caffeine, chilli, ginger and green tea have been shown to induce calorie burning through DIT.     Therefore the inclusion of such foods in the diet could increase energy expenditure and     thereby help in weight control.      The objective of this study is to determine the DIT effects of some plant foods that are     native to Scotland (blackberries, blueberries, red raspberries, wild garlic and sea     buckthorn). These foods have been shown to contain compounds that stimulate DIT. If found to     be effective, these foods could then be used to develop dietary strategies for weight control     in Scotland.   "
26620|NCT02937259|"     Self-admission is a novel treatment tool whereby patients who are well-known to a service who     have high previous utilization of health care are offered the possibility of self-admission     to the inpatient ward for up to seven days without having their motive for admission     questioned. Patients are free to admit themselves because of deteriorating mental health,     acute stress, lack of structure in their everyday life, loneliness, boredom, or any other     reason. The patients decide when they want to admit themselves and can discharge themselves     at any time. The purpose behind the self-admission model is to increase the availability of     inpatient care for severely ill patients, to avoid stressful and possibly destructive visits     to the emergency service, and to decrease total inpatient care utilization. Patients offered     a contract for self-admission usually have a history of repeated and prolonged     hospitalizations. By encouraging them to monitor their own mental health status and allowing     them to seek help swiftly when they are feeling poorly, the delay from first signs of     deterioration to admission can be minimized and full-blown relapse can be avoided, ultimately     reducing the total time spent in hospital. Until now, projects of self-admission have mainly     targeted patients with long-standing psychotic disorders, such as schizophrenia, or bipolar     disorder. Starting in August 2014, a four-year clinical project at the Stockholm Centre for     Eating Disorders began offering self-admission to patients with severe and enduring eating     disorders. The purpose of this study is to determine whether this model is viable in a     specialized eating disorders treatment setting, if it does lead to increased patient     participation and agency and a reduction of the total time spent hospitalized for this     particular patient group, and if it is cost-effective.   "
26621|NCT02937246|"     Previous studies indicated that covered stents are less likely to become occluded in     comparison to bare stents. While the probability of occlusions caused by tumor in-growth is     less in covered stents, they are more likely to spontaneously migrate to a position that is     distal to the original deployment site. However, newer covered stents with improved designs,     such as the partially covered double bare metallic stent used for this study, include     features to mitigate the migration issue. The purpose of this study is to confirm whether the     difference in patency rate between regular covered stents and bare stents, which has already     been well established by existing studies, is also reproducible when double covered stents     are compared against double bare stents.   "
26622|NCT02937233|"     This is a phase 1 trial of one or more administrations of Zika Virus Purified Inactivated     Vaccine (ZPIV). The trial will be conducted under a placebo controlled, double-blind,     randomized allocation of study product. There are four groups in the study. Each group is     testing a different vaccine schedule.   "
26623|NCT02937220|"     The aim of this study is to evaluate the influence of superstructure material on crestal bone     resorption and esthetic outcome of dental implants in patients with single missing tooth in     the aesthetic zone.   "
26624|NCT02937207|"     The purpose of this study is to evaluate the clinical efficacy of traditional Chinese     medicine in the treatment of asthma, and to promote the application in community hospitals.   "
26625|NCT02937194|"     Early childhood caries (ECC) is a global health problem that causes pain and infection to the     children affected. It is a common disease among preschool children in Hong Kong. There is a     great need to improve at-home ECC preventive measures through oral health promotional     activities as early as possible to parents.      The investigators will propose a 4-year randomized controlled trial of family-centered oral     health promotion for new parents which aims to increase the proportion of parents brushing     their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the     transfer of MS from the parents to their infants and then reducing the risk of ECC of the     children at 3 years. The investigators also aim to improve the oral hygiene status of the new     parents and prevention of oral diseases among themselves.      First-time expectant mothers and their husbands will be recruited. The recruited families     will be randomly allocated to the test and control groups. In the test group, personal     hygiene instruction (OHI) for the expectant mothers and their husbands together with oral     health education materials on infant's tooth development and eruption, establishment of     proper feeding, dietary and toothbrushing habits will be given before the delivery of the new     born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral     cavities and perform toothbrushing will be delivered after the babies are born. Comprehensive     data will be collected from the mothers, fathers and the infants in both the test and control     groups at different time points through dental examination, biological testing and     questionnaire survey. The CONSORT statement will be strictly followed when conducting the     clinical trial, analyzing the data and reporting the results.      It is anticipated that the effectiveness of oral health promotion starting at the pregnancy     period and for both expecting mothers and their husbands will be greater in preventing the     infants from developing ECC. Furthermore, establishing good oral health care habits will have     long term benefits, helping safeguard the oral health of the children as they grow and the     family as a whole. This study will also provide much needed evidence for the further     development of oral health policies and oral health promotion programmes in Hong Kong;     specifically how these can be integrated into family health education so as to achieve a     higher effectiveness. This will contribute significantly to the improvement of oral health in     the population of Hong Kong.   "
26626|NCT02937181|"     Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III     open fractures   "
26627|NCT02937168|"     This is an exploratory study with the primary objectives to 1) establish that PET/CT of the     lung can reliably distinguish healthy, non-asthmatic volunteers from patients with asthma and     an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that     reslizumab produces a reduction in lung inflammation in patients with severe asthma and an     eosinophilic phenotype .   "
26628|NCT02937155|"     This study will look at cervical tissue samples in women with abnormal cervical cells to see     if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the     introduction of the HPV vaccine. It will compare women who have been exposed to the HPV     vaccine with those who have not.   "
26629|NCT02937142|"     Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder which starts     in childhood and is characterized by symptoms of attention deficit, hyperactivity and     impulsivity. Persistence into adolescence is frequently associated with among other low     educational achievement, interpersonal difficulties, anxious and depressive symptoms and     sleep problems. Treatment guidelines recommend psychological treatment as part of the     treatment plan, however compared to children and adults, there is still a substantial lack of     knowledge about appropriate psychological treatment in adolescents. The present study     examines a psychological intervention for adolescents with ADHD, cognitive behavior group     therapy. The intervention consists of 12 weekly cognitive behavioral therapy sessions     addressing core difficulties and concerns of the adolescent population with ADHD. The     investigators wish to determine the efficacy of group therapy in adolescents with ADHD who     receive medical treatment but still have impairing ADHD symptoms.   "
26632|NCT02937103|"     The overall purpose of this study is to explore the therapeutic effect of CD123-targeted     chimeric antigen receptor T(CAR-T) cells in the treatment of Myeloid Malignancies.   "
26633|NCT02937090|"     Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on     intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota     maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the     investigators will compare the intestinal microbiota composition and diversity in PCOS with     age, BMI-matched control and then assess whether intestinal microbiota modification is     associated with clinical and biological parameters.   "
26634|NCT02937077|"     Background:      Different studies with real-life data and randomized controlled trials have shown a detection     rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic stroke     using insertable continuous cardiac monitoring for 6 months. More studies are needed,     however, to identify factors which can be used to select the patients where the possibility     of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration of     rhythm monitoring, to determine the optimal deﬁnition of short-term AF that warrants     intervention and to evaluate whether intervention results in improved clinical outcomes.      Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to     evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients     admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80     years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for     12 months for the purpose of AF detection. Biomarkers that may identify patients, who could     derive the most clinical benefit from the detection of AF by prolonged monitoring, are being     studied.      Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in     patients with cryptogenic stroke and TIA that potentially can improve secondary prevention.     The study will provide information on biomarkers that may be used to select cryptogenic TIA     and stroke patients for long-term monitoring as well as information on the significance of     short-term AF and optimal duration of cardiac rhythm monitoring.   "
26635|NCT02937064|"     The purpose of this study is to assess both osteoarthritis and other pathological knee     conditions from the combination of signals that are known to provide information on the knee     joint.   "
26636|NCT02937051|"     This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who     will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by     the tobacco product smoked:        1. own-brand CTC (positive control),        2. original-flavored Black & Mild (B&M) cigar,        3. apple-flavored B&M cigar,        4. cream-flavored B&M cigar, and        5. wine-flavored B&M cigar.   "
26637|NCT02937038|"     Purpose:        1. Develop reference values for hydration biomarkers for children of 3 to 13 years old        2. Explore the association between children's and parents' hydration markers and fluid          intake habits in children aged 3-13 y        3. Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children          aged 3-13 y        4. Evaluate the differences in hydration markers between school and non-school days in          children aged 3-13 y        5. Examine the role of different foods and fluids on hydration in children (3-13 y) and          parents   "
26638|NCT02937025|"     This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage     Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF)   "
26639|NCT02937012|"     The primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, treatment     is based in the use of ursodeoxycholic acid (UDCA) at a daily dose of 13 to 15 mg/kg, without     other treatment options. Patients with good or complete response to UDCA have more liver     transplant-free survival and delay histologic progression compared to patients with partial     or no response. Nowadays there is an estimated partial response to UDCA in approximately 30     to 50% of patients with PBC. There is a need for new second line management strategies for     patients without a biochemical response to UDCA.      The addition of bezafibrate to the treatment of PBC patients with partial biochemical     response to UDCA, will increase the biochemical response and improve the long term prognosis?     And if so, which are the efficacy and security of bezafibrate in PBC patients without     biochemical response?   "
26640|NCT02936999|"     The purpose of this study is to determine the safety and usefulness of oral Vitamin D     supplementation in subjects with in situ carcinoma. More specifically, this study is being     done to (1) understand the effect of Vitamin D supplementation on behavior of breast cancer     cells and (2) the development of invasive breast cancer disease.   "
26641|NCT02936986|"     The differential diagnosis of gastric submucosal tumors by endoscopic ultrasound is currently     suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic     technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography     (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and     subcellular levels. This study aimed to describe nCLE interpretation criteria for the     characterization of gastric submucosal tumors, with histopathological correlation, and to     perform the validation of these criteria.   "
26642|NCT02936973|"     The primary objective of this multicenter randomized controlled trial is to evaluate     treatment effectiveness of intervening simple obesity people with catgut implantation at     preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate     safety and superiority of treating simple obesity with catgut implantation at acupoints to     provide high-level evidence for it clinically.   "
26643|NCT02936960|"     The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided     fine-needle aspiration (EUS-FNA) is currently suboptimal. Needle-based confocal laser     endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge     FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo     imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe     nCLE interpretation criteria for the characterization of pancreatic masses, with     histopathological correlation, and to perform the validation of these criteria.   "
26644|NCT02936947|"     That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment     in patients with tumors that are moving with respiration like breast or lung cancers. The use     of a High Frequency Percussive Ventilation system leads to the cessation of respiratory     motions while administering radiotherapy (RT) to tumors which allows a reduction of the     amount of irradiated normal tissues and which potentially decrease radiation-induced     collateral damages.   "
26646|NCT02936921|"     Several decades ago, France has made the choice to implement a national prevention program     for congenital toxoplasmosis. The identification in their first trimester of pregnancy of all     pregnant women who are susceptible to Toxoplasma infection has been mandatory since 1985. In     1992, the decision was made to extent the program to the monthly retesting of all women     identified as not immune, in an attempt to reduce the number of severely infected children.      The systematic detection of all maternal and congenital infections has generated many     questions from clinicians, biologists, parents and older patients, on the short and long-term     prognosis of congenital toxoplasmosis, on the best tests to use to diagnose infections in     mothers and children, on the efficacy of existing treatments, and on how to manage patients     in the long-term.      The need to answer these many questions has prompted the medical team working within the     laboratory and the outpatient department of the Parasitology Department at the Croix-Rousse     Hospital in Lyon to implement a clinical research program. It is based on the systematic     inclusion in our cohort of all pregnant women whose infection is confirmed, on their follow     up, in order to monitor the outcome of pregnancy 2) and on the follow up of their children in     order to confirm their infection or to rule it out. All congenitally infected subjects     undergo clinical examinations, serological tests and ocular examination at least once a year     without age limit.      The following data are prospectively collected in a dedicated database: gestational age at     maternal infection and corresponding serological profile; type and dates of maternal     treatment; findings of ultrasound tests and amniotic fluid analysis; serological and clinical     findings at birth; types and dates of postnatal treatment; postnatal serological profiles;     infection status at one year of age; long term clinical (ophthalmologic) et serological     findings.      These data have allowed producing original findings on the risk of maternal-foetal     transmission according to gestational age at maternal infection, on the long term     ophthalmological outcome of congenital toxoplasmosis and to offer guidelines for the     diagnosis, treatment and follow-up of maternal and congenital infections.      These efforts are still to be maintained in the future in order        -  to further analyse the impact of puberty, pregnancy, or adult co-morbidities on the risk          of ophthalmological events        -  to increase precision around our risk estimates for materno-foetal transmission,        -  to continue innovating in terms of diagnostic strategy to improve tests performances and          reduce costs        -  to explore new potential clinical outcomes such as neuropsychiatric disorders associated          with congenital and postnatal infection        -  to determine if infections due to oocysts could have different clinical outcomes than          those due to the ingestion of cysts        -  to assess the efficacy of treatments for maternal and congenital infections   "
26647|NCT02936908|"     Retrospective multicentric observational study exploring the population of adult     neuromuscular patients presenting a respiratory distress requiring their admission in an     Intensive Care Unit (ICU) for ventilatory support.      Research of markers associated with long term mortality and ventilatory status.   "
26648|NCT02936895|"     Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in     developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children     under 5 years. This rate was 2% in 2007.      Some studies have shown that supplementing with vitamin D reduces disease of the respiratory     tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell     lines. Studies about the role of vitamin D supplementation in pneumonia in children are     inadequate to conclude about its role.      The aim of this study is to determine the efficacy of vitamin D supplementation in     Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of     hospitalized patients with community-acquired pneumonia.   "
26649|NCT02936882|"     This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical     emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is     compared to peroperative gastric aspirate with nasogastric tube.   "
26650|NCT02936869|"     The purpose of this study is to identify the causal impact of performance-based monetary     incentives in increasing postnatal care (PNC) referrals by traditional birth attendants     (TBAs), via a randomized controlled trial (RCT).   "
26651|NCT02936856|"     Primary liver cancer is one of the most common malignant tumor and leading cause of     cancer-related death worldwide. Basically therapeutic strategies were considered and given     based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and     distribution of malignant lesions were extreme important. Enhanced CT or MRI is routinely     imaging scans to detect and identify lesions. Unfortunately, some malignant lesions usually     presented untypical imaging characteristics, especially among lesions no larger than 1 cm,     which misleading to the exact staging of liver cancer and the optimal therapeutic strategies.      Basically most of blood supply for malignant liver tumors is from the hepatic artery. Based     on this fact, hepatic arterial digital subtraction angiography could potentially elevate the     accuracy and sensitivity of detection malignant lesions numbers and distribution.      In this study the investigators will compare the numbers and distribution of malignant     lesions before and after hepatic arteriography, then to revise the staging of liver cancer     and to provide better therapeutic strategies.   "
26652|NCT02936843|"     Diabetic neuropathy (DN) is the most common chronic complication of diabetes, affecting up     to50% of individuals with type 1 diabetes (T1DM).      Multiple pre-clinical and clinical studies demonstrate a pathogenic role for inflammation,     especially cytokine production, in the disease course of DN and CAN. This suggests that     agents with known anti-inflammatory properties, such as salicylates, may prevent the     development of DN and the pain associated with DN. This study builds upon and expands on     prior work done by the investigators with salsalate, a pro-drug form of salicylate, as an     agent to address inflammatory pathways in people with T1DM.   "
26653|NCT02936830|"     The aim of this study is to compare the efficacy of dentine hypersensitivity reduction using     in office paste formula containing nanoHydroxyapatite with the commercially available     fluoride (duraphat) and a placebo in treating hypersensitivity in a single visit.   "
26654|NCT02936817|"     Primary:      The primary objective of this study is to evaluate the effect of the Aerobika® device on the     aerosol deposition pattern of concomitant inhalation medication using FRI.      Secondary:      The secondary objective of this study is to evaluate the effect of the Aerobika® device on     the airway volume (iVaw), lung and lobe volume (iVlobes), airway resistance (iRaw),     hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping     using FRI.   "
26655|NCT02936804|"     The present study is a single arm clinical trial aiming to improve the key technology in the     diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70) are     planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm     (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening     test will be carried out by a pre-specified protocol.   "
26656|NCT02936791|"     This observational study will collect blood and urine and clinical information from     individuals with early-stages of polycystic kidney disease (PKD), their unaffected siblings     and normal volunteers to create a biobank, also called a biorepository. The long-term goal is     to develop new knowledge on biological markers or biomarkers that indicate changes in the     disease progression. An understanding of biomarkers for early renal cyst growth will benefit     PKD patients as new therapies are being developed and tested.   "
28981|NCT02906306|"     The objective of this study is to determine whether individual and/or group occupational     therapy leads to changes in generalized self-efficacy and psychological well-being, and to     identify the type of therapy that has the best effects on older adults.   "
26658|NCT02936765|"     This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two     different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative     change in neck disability index. The evaluation will include clinical and radiological     parameters.   "
26659|NCT02936752|"     This phase Ib trial studies the side effects and best dose of entinostat when given together     with pembrolizumab in treating patients with myelodysplastic syndrome after deoxyribonucleic     acid (DNA) methyltransferase inhibitor (DNMTi) therapy failure. Entinostat may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and     spread. Giving entinostat together with pembrolizumab may work better in treating patients     with myelodysplastic syndrome after DNMTi therapy failure.   "
26660|NCT02936739|"     This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two     different cervical disc prosthetic devices with respect to postoperative change in neck     disability index. The evaluation will include clinical and radiological parameters.   "
26661|NCT02936726|"     There is evidently great potential in implementing workplace health promotion programs, but     more randomized trials are needed to determine which interventions are worksite-effective in     helping to decrease inactive behaviors and increase engagement in healthy lifestyle     activities. For employers, it could mean improving the health and productivity of employees.     For workers, especially those in physically and/or psychologically demanding positions, it     could mean developing strength, muscular endurance and agility to reduce musculoskeletal pain     while developing the stress reduction skills that reduce long-term sickness and absenteeism     risks. While changing behavior in a complex workplace is, as seen in multiple studies,     difficult due to the need to change workplace and organizational culture between employers     and employees, this study aims to identify the effectiveness of workplace interventions in     relation to counseling for university employees to increase overall work fitness without     affecting any hierarchal interactions at the work site. Simply put, the investigators will     examine the benefits of a workplace exercise and mindfulness (two-prong) intervention (in     combination) vs. a group who just receive a workplace exercise intervention. Both     interventions will be guided by health coaches. Given the limited research with health     coaching and workplace interventions for university workers, the aim is to contribute to a     developing research literature. This study is geared to engage university employees at their     workplace over a 3 month period. Participants will be assessed through pre and post physical     and psychological measures and will also undergo semi-structured interviews (SSI).   "
26662|NCT02936713|"     To select among different dietary and clinical conditions the most appropriate to assess the     impact of a fermented milk product on gas-related symptoms   "
26663|NCT02936700|"     Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000     suicide attempts every year. SB management is therefore a major public health issue.     Recently, investigators have demonstrated the interest of acceptance and commitment therapy     (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in     depressed patients having a history of suicide attempt within previous year (i.e actual SB     disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth     edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal     and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly,     previous functional MRI (fMRI) studies have also reported the modulation of these regions by     ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to     identify biomarkers of SB and its improvement by ACT.      The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB     disorder. Patients having a history of SB within previous year were randomized in an ACT     program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after     the completion of the group, they performed 3 tasks during fMRI: implicit emotional     visualization, Cyberball game, motivational task Investigators will compare cerebral     activations between groups, between pre and post intervention as well as measure baseline     cerebral activations associated with improvement of suicidal ideation during follow up.   "
26664|NCT02936687|"     The objective of this study is to identify insulin-specific cerebral blood flow (CBF) control     mechanisms, and establish cerebrovascular responsive baseline in younger (18-45 yrs)     metabolic syndrome adults (MetSyn) who are at substantial risk of stroke and other types of     cardiovascular mortality even if they never develop diabetes. The central hypothesis is that     vasodilator actions of insulin are impaired in MetSyn due to loss of dilator and gain of     constrictor signals. This study will focus on 2 mechanisms that likely limit CBF in MetSyn:     1) Disruption of nitric oxide (NO) vasodilation, and 2) Exaggerated endothelin (ET-1)     constriction. Three specific aims will be addressed: Aim 1: To test the hypothesis that     physiologic surges of insulin acutely increase CBF in young adults, but adults with MetSyn     exhibit paradoxical insulin-mediated vasoconstriction. Aim 2: To test the hypotheses that key     mechanisms responsible for poor CBF in MetSyn are shifts in NO and ET-1 signaling.     Specifically, in healthy controls, NO mediates robust dilation, with little to no ET-1     constriction. In contrast, adults with MetSyn exhibit uncoupled NO synthase (NOS) and     exaggerated ET-1 constriction. Aim 3: To test the hypothesis that insulin regulation of CBF     is regionally distinct (e.g. Middle Cerebral Artery (MCA) reactive than Anterior Cerebral     Artery (ACA) or basilar), and the negative effects of insulin resistance (IR) are similarly     regionally specific.   "
26665|NCT02936674|"     The purpose of this study is to examine the effects of complex, broad-band spectra light on     the production of melatonin in humans.   "
26666|NCT02936661|"     It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women     to delivery by cesarean section will be recruited in this study. In addition to routinely     oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered     their babies, and those in control group will receive placebo. The incidence of postpartum     hemorrhage, the amount of bleeding, as well as the side effects will be observed.   "
26695|NCT02936284|"     This study evaluates the effect of a music enhancement program to strengthen the motivation     to engage in music related behaviors rather than eating in infants who are high in motivation     to eat. Half the participants will participate in a Music Together Program, while the other     half will participate in a Play Date control. For both groups, participants will attend 34     weekly sessions for one year, and 12 monthly sessions the next year, in 4 cohorts.   "
26667|NCT02936648|"     The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to: (1)     increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in     vulnerable, high-risk groups, (2) Increase linkage to specialized HCV care among VISN 1 VA     Veterans diagnosed with HCV infection, and (3) Evaluate whether race, ethnicity, gender, or     other markers of social disparity influence completion of HCV testing and linkage to     specialty care, and whether disparities are reduced by the planned VISN 1 VA HCV Quality     Improvement (QI) program. The central focus is to reduce delays in diagnosis and linkage to     treatment evaluation, management of comorbidities and contraindications, and subsequent     initiation.   "
26668|NCT02936635|"     The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in     patients with ALS.   "
26669|NCT02936622|"     This randomized multi-center study is intended to compare different coatings on stents for     treatment of lesions of the above-the-knee femoropopliteal artery.   "
26670|NCT02936609|"     This innovative and timely study will measure the impact of Affordable Care Act (ACA)     Medicaid expansions on cancer screenings and preventive services. To assess this natural     policy experiment, the investigators will use electronic health record data from the     Accelerating Data Value Across a National Community Health Center Network (ADVANCE) clinical     data research network (CDRN) of the National Patient-Centered Clinical Research Network     (PCORnet).   "
26671|NCT02936596|"     Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome     induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents   "
26672|NCT02936583|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
26673|NCT02936570|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
26674|NCT02936557|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
26675|NCT02936544|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
26676|NCT02936531|"     In this study the investigators aim to identify and characterize a potential     neurophysiological biomarker by mapping functional networks of brain activity (Brain Network     Activation, BNA) based on analysis of evoked response potential (ERP) signals in both     asymptomatic FMR1 premutation carriers and in patients with various stages of FXTAS.     Additionally correlations will be studied between these BNA scores and demographics (gender,     age and disease duration) as well as genetic mutation and clinical scores.   "
26677|NCT02936518|"     A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified     breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In     the previous cohort, babies were excluded from the study if they had previously undergone an     attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look     at those babies who did undergo a previous frenotomy to determine:        1. the presence of continued problematic breastfeeding symptoms        2. if further tongue tie or lip tie release improves those outcomes   "
26678|NCT02936505|"     A controlled randomized, open-label, multi-centre study evaluating if an immunosuppressive     protocol, based on ATG-induction, once daily tacrolimus-dose (Advagraf®), mycophenolate     mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD)     after lung transplantation, in comparison with a standard cyclosporin-based protocol.   "
26679|NCT02936492|"     Systemic safety following single and multiple dermal administration of BAY1003803   "
26680|NCT02936479|"     This is an open-label, single arm trial in which patient who have ongoing antibody mediated     rejection of a kidney transplant deemed refractory to maximal medical therapy are given the     complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing     antibody mediated injury. A maximum of 5 patients will be enrolled.   "
26681|NCT02936466|"     Bipolar disorder is a condition characterized by succession of episodes- manic, hypomanic,     and depressive episodes. Major risks factors of relapses are poor compliance, sleep disorder,     and toxics consumption. The aims of psychoeducation programs are to increase compliance and     knowledge about bipolar disorder. Serious game are supposed, in bipolar disorder, to     strengthen the efficacy of psychoeducation programs. Bipolife® is a serious game which     purpose is to help bipolar patients to deal with their conditions, through 3 mains messages :     to pursue the treatment, to have daily routine and to request the psychiatrist in case of     relapse.      This is a multicentric randomized controlled study with two harms parallels. After a classic     psychoeducation group program, patients are randomized in two groups : interventional group     and control group with treatment as usual.      The main objective is to evaluate the observance in the two groups. The other objectives are     to evaluate daily routine, global functioning, and access to health care. Evaluations are     realized at one and four months after inclusion visit. Acceptability and satisfaction about     the serious game Bipolife® will be assessed in the interventional group.   "
26682|NCT02936453|"     STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop     Epidural Electrical Stimulation (EES) in combination with overground robot assisted     rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).      Patients will participate during 9-11 months, during which there will be        -  Pre-implant evaluations (6-8 weeks)        -  Device implantation and stimulation optimization (6-8 weeks)        -  Overground rehabilitation training with EES (5-6 months) In the period after          implantation, participants need to be present for testing and training, 4 days per week          at the CHUV University Hospital in Lausanne (lodging can be provided).      At the end of the protocol, the study aims to make the patients walk better and faster,     however, as this is the first study of its kind, success is not guaranteed.   "
26683|NCT02936440|"     The state of hyperhydration in critically ill patients with acute kidney injury (AKI) is     associated with increased mortality. Bioelectrical impedance vector analysis (BIVA) appears     to be a viable method to access the fluid status of critical patients but has never been     evaluated in critical patients with AKI. The objective of this study is to evaluate the     hydration status using BIVA in critical patients under intensive care at the time of AKI     diagnosis and to correlate this measurement with mortality. A sample of 224 patients with AKI     will be evaluated by BIVA and followed until they are discharged or death in intensive care     unit and the BIVA vectors will be analysed to define differences in hydration characteristics     from each group.   "
26684|NCT02936427|"     Post-op analgesia is the most important part of early and safe patient recovery in thoracic     surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly     improved with optimal pain control and complications and length of stay are minimized. Most     post-op thoracic complications are from decreased respiratory effort, failure to clear     secretions and pulmonary infections from retained sputum with subsequent sequelae. Good     post-operative analgesia not only prevents these complications but also considerably enhances     early mobilization and thus, decreased hospital stay and efficient resource allocation. Early     post-operative pain is also associated with late and chronic post thoracotomy pain syndromes     which can be debilitating.      Pain following thoracic surgery is different to the standard surgical incision pain and is     due to intercostal nerve damage, compression or traction injury to the nerve. This occurs     with the incision, rib retraction, and is compounded by the on-going need for respiratory     effort. The approach to managing this pain is multi-modal analgesia. The standard regimen     stretches from preemptive analgesia and preoperative placement of thoracic epidurals to     post-op opioid infusions. However, non-invasive pharmacology includes paracetamol, non     steroidal anti inflammatory drugs (NSAIDs), mild and moderate opioids as well as     anti-convulsants like pregabalin. However, opioid use has well-known side effects including     central nervous system (CNS) and respiratory depression which unfortunately delay mobility     and recovery. This has motivated opioid-sparing strategies.      The investigators study aims to assess whether the addition of perineural dexamethasone (a     steroid) to the current practice of local anaesthetic wound catheters increases the efficacy     and duration of analgesia provided.   "
26685|NCT02936414|"     The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis     for schizophrenia has attracted increasing attention of the researchers, substantial     evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α     markedly elevated in patients with schizophrenia which may be particularly relevant for the     cognitive impairment and metabolic disturbance of schizophrenia. In recent years, it has been     demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism,     reducing the proinflammatory status and improving cognition. As the investigators known, the     report of berberine being used in schizophrenia is rare. This protocol is aim to evaluate     berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism,     cognition in patients with schizophrenia.   "
26686|NCT02936401|"     The purpose of this study is to determine the efficacy of Mindfulness Based Stress Reduction     (MBSR) to alleviate stress, anxiety, and depressive symptoms, and improve attention among     patients aged 60 or older who suffer from HIV-associated neurocognitive disorders (HAND) and     have maximized treatment options.   "
26687|NCT02936388|"     Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver     metastases in patients with advanced uveal melanoma with respect to progression-free survival     and exploratory comparison of secondary endpoints regarding application, activity, adverse     effects and impact on quality of life in a randomized study design.   "
26688|NCT02936375|"     This study is a 52-week, randomized, open, active-controlled trial of patients with active     diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic     agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed     with azathioprine, both combined with steroids.   "
26689|NCT02936362|"     Bread is the most common grain product in the world, with consumption surpassing 3 billion     individuals per year. Sourdough whole-grain bread is considered a healthy alternative to     white, refined-wheat bread.      This cross-over study will test the effect of consumption of sourdough bread compared to     white bread following a short dietary intervention period (one week) on multiple clinical     parameters and gut microbiota.   "
26690|NCT02936349|"     Current HHT guidelines recommend CT scan to detect new or recurrent PAVMs after     embolotherapy. Recent studies using transthoracic contrast echocardiography (TTCE) shunt     grade for PAVM screening suggest that graded TTCE can accurately predict the size of PAVMs on     chest CT and their amenability to embolization. This study's purpose is to evaluate whether     TTCE shunt grade can also accurately predict PAVM size and amenability to treatment in     patients who are post-embolization.   "
26691|NCT02936336|"     Osteoporosis is a serious global health problem, second only to cardiovascular disease.     Osteoporosis is the most common metabolic bone disease in the elderly population,     characterized by loss of bone mineral density (BMD) and continuous destruction of bone     microstructure, especially in postmenopausal women. It gives rise to bone fragility and     fracture risk. Moreover, as people grow older, falls frequently occur with high severity, and     nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic     fractures increase mortality, morbidity, chronic pain, and the cost of social care and it     decreases the quality of life. Here, investigators plan to perform different exercise     interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older     adults to evaluate whether exercise intervention could improve the bone mineral density,     physical fitness, muscle strength or quality of life.   "
26692|NCT02936323|"     Protocol PEN-221-001 is an open-label, multicenter Phase 1/2a study evaluating PEN-221 in     patients with SSTR2 expressing advanced gastroenteropancreatic (GEP) or lung or thymus or     other neuroendocrine tumors or small cell lung cancer or large cell neuroendocrine carcinoma     of the lung.   "
26693|NCT02936310|"     The primary objective of this proposed one-year (January 01, 2017 to December 31,2017)     project is to assess whether a mindfulness based intervention('Mindful Living With Stress')     will be effective at helping nurses caring for HIV/AIDS patients in China to reduce stress.     Based on the efficacy of previous studies in stress reduction, it is hypothesized that     'Mindful Living With Stress' will be an effective, feasible and affordable stress reduction     program in China.   "
26694|NCT02936297|"     Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence     of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved     by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The     pathologic mechanism of the disorder is unknown, and there are no known biomarkers or     associated histopathologic findings. In this prospective, randomized controlled trail, we are     investigating the utility of patient reported symptom questionnaires, as well as stool gluten     and urine quantification tools in patients with NCGS and healthy controls.   "
26696|NCT02936271|"     The purpose of this study is to evaluate the effectiveness of Vasculera in reducing post     procedural pain, bruising and edema in the post procedure period for patients diagnosed with     C2-C5 disease requiring an intervention(s).      The hypothesis is that Vasculera will reduce post procedural pain, bruising and edema for     patients requiring an intervention.      This will be a randomized, double-blind, placebo-controlled study. Vasculera is a specially     formulated prescription medical food product for the clinical dietary management of the     metabolic processes of chronic venous insufficiency. Vasculera has limited side effects,     please see the product insert.      A total of 110 patients will be enrolled into this study. Patients will be randomized to     receive Vasculera (Study Product) or placebo. Study Product or placebo will be prescribed as     one (1) tablet twice a day.   "
26697|NCT02936258|"     The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard     of care systematic TRUS guided biopsy in the detection of clinically significant and     clinically insignificant prostate cancer in men without prior biopsy. The implication of this     trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard     of care in the diagnosis of prostate cancer.   "
26698|NCT02936245|"     Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over     the age of 50. They claim that surgical treatment of myelopathy, especially of the mild and     moderate forms, has not shown better results than conservative treatment in the long term,     and criteria for the indication and the timing of the operation have not been established. In     order to get some more reliable data, a long-term follow up observational study will be     started to confirm the effects of long term for conservative treatment.   "
26699|NCT02936232|"     The aim of this study is to construct multi-center sepsis registry that can be used for data     warehousing and clinical research.   "
26700|NCT02936219|"     In this Austrian observational study preterm infants born with a birth weight <1500 g and a     gestational age <32 weeks will be investigated at the neonatal outpatient clinic. Infants     will be stratified according their feeding regimen (breast, formula and combined feeding) and     their introduction of solid foods (early complementary feeding group: <17th week of life     corrected for prematurity, late complementary feeding group: ≥17th week of life corrected for     prematurity). Nutrient intakes and anthropometric parameters will be assessed at term, 6     weeks, 12 weeks, 6 months, 9 months and 12 months - all corrected for prematurity.   "
26701|NCT02936206|"     The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal     women before and after exposure to one of the two commonly used breast cancer drugs,     tamoxifen or fulvestrant.   "
26702|NCT02936193|"     The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for     the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted     a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2     lymph node dissections for EGC.   "
26703|NCT02936180|"     Influenza, a vaccine-preventable respiratory disease, is ranked 8th among the causes of death     in the Canadian population. Among rheumatoid arthritis (RA) patients, the incidence of both     seasonal influenza and serious influenza-related illness (IRI) are increased. Despite being a     high priority group targeted for vaccination, the diagnosis of RA and other patient-specific     factors (i.e. older age, treatment, current smoking) are linked to impaired vaccination     responses.      Thus the burden of influenza among people with RA is disproportionally high, and     interventions to improve responses to influenza vaccination are urgently needed. Strategies     to optimize protection in another vulnerable group, the elderly, include the use of     quadrivalent vaccines, higher antigen doses, and adjuvants. A high-dose, trivalent,     inactivated influenza vaccine (HD-TIV) has recently been shown to have a similar safety     profile to standard dose vaccine (SD-TIV) with improved immunogenicity and protection in     adults ≥65 years of age. Whether or not analogous strategies to improve responses to     influenza vaccine will enhance protection in people with RA is unknown. The investigators     hypothesize that the use of the HD-influenza vaccine will improve vaccine-induced protection     (i.e. seroconversion and seroprotection) in people with RA compared to SD-influenza vaccine.     The investigators propose to conduct a stratified, randomized, modified double blind,     active-controlled trial to assess immune responses to two commercial influenza vaccines     containing different antigen doses in individuals with RA.   "
26704|NCT02936167|"     In children fluids are supplemented during surgery to provide volume, to maintain blood     glucose levels, electrolyte balance and to meet the ongoing fluid losses during surgery.     Fluid replacement during surgery since decades has been based on the Holliday and Segar     method.These authors proposed that water maintenance in children includes: 100 millilitre     (ml)/100 kilocalorie (kcal) for the first 10 kg of body weight, 50mL/100 kcal for 11-20 kg     and 20mL/100 kcal for every kilogram of body weight above 20 kg. The maintenance electrolyte     requirements of 3 mEq/100 kcal for sodium and 2 mEq/100 kcal for potassium per day, were     based upon the electrolyte composition of breast and cow's milk. Based on these     recommendations hypotonic fluid (0.45% saline) was considered as the ideal fluid for     maintenance in children undergoing surgery.      Since the past many years there have been many documented cases of hyponatremia after     administration of hypotonic fluids with potential for serious neurological injury in this     group of patients.The use of Holliday and Segar's formula to calculate the maintenance fluid     regimen in postoperative children leads to an overestimation of the volume of fluid needed,     as there is a low urine output in this period. The postoperative period is at risk for     non-osmotic secretion of anti-diuretic hormone (ADH), which reduces the ability of kidney to     excrete free water and carries risk for development of hyponatraemia.Authors in favour of     hypotonic solutions feel that hyponatremia results from excessive volume of fluid and     isotonic solutions have risk of hypernatremia, interstitial fluid overload, excessive sodium     excretion, and hyperchloremic metabolic acidosis.      Based on the increased incidence of hyponatremia in children undergoing surgery, the     paediatric anaesthesia societies [Society of Paediatric Anesthesia (SPA), Paediatric     Anaesthesia Society of Great Britain and European society of Paediatric Anesthesia (ESPA)]     put forward guidelines for the type and amount of fluid to be administered during     surgery.Since then normal saline is the commonly used fluid during the perioperative     period.However recent studies have shown that the use of normal saline is associated with     development of hyperchloremic metabolic acidosis and poor outcome.      Ringer lactate (RL) is a commonly used intravenous fluid during surgery and has been found to     have decreased possibility of producing hyponatremia although it is a slightly hypotonic     solution.Plasmalyte is an isotonic fluid which has been shown to maintain electrolyte balance     and prevent hyponatremia as well as hyperchloremic acidosis in adult population.However     plasmalyte has been less frequently used in paediatric population.Therefore this study is     planned with the aim of comparing intravenous fluids, ringer lactate and plasmalyte in the     perioperative period regarding the incidence of hyponatremia produced by these solutions,     their effect on electrolytes and blood gases in children undergoing elective surgery.   "
26705|NCT02936154|"     The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of     PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.   "
26740|NCT02935699|"     This will be a multicenter, parallel group, randomized, double-blind, active controlled,     Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine     injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 256 patients (1:1     ratio) with acute urticaria requiring treatment in Emergency Departments, hospitals, Urgent     Care Centers, Allergy Clinics, and etc.   "
26706|NCT02936141|"     The aim of this project is to describe the mental health status of the homeless people in     Maputo and Matola utilising standardised clinical and socio-demographic assessments.     Simultaneously; the study aims to determine the influence of a psychosocial intervention in     patients with apparent signs of mental illness, aiming at his/her family reintegration; This     study is conducted hypothesizing that the familial reintegration after intervention would be     the same across patients with different mental disorders.   "
26707|NCT02936128|"     The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active     Comparator in patients with chronic venous leg ulcers.   "
26708|NCT02936115|"     The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active     Comparator in patients with chronic diabetic foot ulcers.   "
26709|NCT02936102|"     The purpose of this first-in-human study of FAZ053 is to characterize the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053     administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult     patients with advanced solid tumors.      By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors,     Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in     activation of an antitumor immune response by activating effector T-cells and inhibiting     regulatory T-cells.      This study has been designed as a Phase I, open-label, multi-center study with a dose     escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose     expansion part of FAZ053 as single agent and in combination with PDR001.      FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as     every 6 weeks may be evaluated in parallel.      A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until     the patient experiences unacceptable toxicity, confirmed disease progression per immune     related Response Criteria and/or treatment is discontinued at the discretion of the     investigator or the patient.   "
26710|NCT02936089|"     Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease     entailing different prognoses. There were significant differences in the therapeutic effect     between different subgroups of AE AML. Therefore, risk stratification-directed therapy is     very necessary for AE AML.   "
26711|NCT02936076|"     The purpose of this study is to examine the psychological benefits of chronic exercise as     well as the effects of exercise training on eating behaviors and stress-induced overeating in     overweight and obese women. Participants will be randomized to an 12-week exercise condition     or a delayed exercise condition. Assessments will occur at baseline, 6 weeks, and 12 weeks     and will include answering surveys in real-time using smartphones, several assessments of     eating behaviors and dietary intake, and questionnaire measures of factors which could     mediate the relationship between exercise and eating. Participants will be compensated for     completing assessments and for adherence to the exercise protocol.   "
26712|NCT02936063|"     When patients undergo neck dissection surgeries, the current standard of care is to close the     skin layer with either metal staples, which are removed a few days post-operatively, or with     sutures, which can be absorbable or removed. To date, there is no conclusive data in the     literature that definitively suggests one method is better than the other, with regard to     wound complications or mature scar cosmesis. Currently, skin closure method is chosen by each     individual surgeon, and is based on personal preference, factoring in evaluation of the     wound. The goal of the study is to compare the two methods of skin closure, and the measured     outcomes the investigators will be looking at are patient satisfaction, wound complications,     and mature scar cosmesis. The investigators will be randomizing patients undergoing head and     neck surgery to receive either staples or subcuticular sutures, and giving them surveys at     their post-operative clinic visits to evaluate the outcomes, to determine if patients     perceive one method to be superior to the other.   "
26713|NCT02936050|"     The cost related to management of heart failure is significant, both with respect to the     financial costs and the suffer of patients. Still as much as 50% of heart failure patients     are readmitted within 6 months after hospitalization for decompensated heart failure.      Specialized nurses have a growing role in diagnostics and follow-up of outpatient HF     patients, and adding ultrasound diagnostics to the nurses consultations may improve care. In     heart failure patients the use of ultrasound as a tool for assessing volume status and     guidance of diuretic therapy are promising. Aim of the study is to evaluate the feasibility     and reliability of echocardiographic acquisitions by heart failure nurses to assess cardiac     function indices and assess volume status in outpatient heart failure clinics combined with a     telemedicine approach for near real-time interpretation of the recordings by a cardiologist     specialized in echocardiography and heart failure at a remote location.   "
26715|NCT02936024|"     Undescended Testis (UDT) is the most common congenital anomaly of the genitalia in boys and     it is commonly managed by surgical intervention. Patients with intra-abdominal or non     palpable testis, specifically, are often managed using a laparoscopic assisted orchidopexy, a     common surgical technique to bring undescended testes down into the scrotum. Evidence in the     medical literature to support the superiority of either one stage or two stage gubernaculum     sparing laparoscopic orchidopexy (GSLO) is lacking. Due to this reason, this study focuses on     the effects of one stage versus two stage GSLO on a patient important outcome: testicular     atrophy.   "
26716|NCT02936011|"     Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total     Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and     re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular     Scaffold (BVS).   "
26739|NCT02935712|"     This study will be a phase I, first time in human (FiH), randomized, single-blind,     placebo-controlled, SAD study in male patients with T2DM, performed at a single study center.     The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65     years will be included.   "
27268|NCT02928822|"     The purpose of this study is to determine whether VR based language rehabilitation scenario     based on the core premises of ILAT has a beneficial effect on the linguistic performance     (faster retrieval of the target lexicon and general fluency) of Broca's aphasia patients.     Furthermore, it aims at testing the effects of cueing (visual and auditory) on word     retrieval.   "
26717|NCT02935998|"     1. The title of this study is a multi-center,non randomized,open-labeled,intervention          study:the efficacy and safety of intramuscular ziprasidone for three days in patients          with acute psychotic agitation.        2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in          patients with acute psychotic agitation in daily clinical practice.        3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in          patients with acute psychotic agitation in daily clinical practice.2.To compare the          efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the          different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular          ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the          measured based administration according to severity of symptoms.5.To compare the          efficacy and tolerance of ziprasidone im between the monotherapy and combination with          other antipsychotic drug in clinical practice.        4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on          schizophrenia. But in the foreign country, ziprasidone im also is approved to treat          psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical          practice of China, ziprasidone im is also used to treat other patients, although the          evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation          is effective and safe.        5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and          the hypothesis：The researches of ziprasidone mesylate injection in our country are more          concentrated in schizophrenia at present, while in foreign countries ziprasidone is          approved for psychotic agitation, including mania etc. It's also used for substance          abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone          mesylate injection is effective in the treatment of acute agitation, and it's well          tolerated.   "
26718|NCT02935985|"     The bio-markers substudy of EsICH is designed to recruit patients with acute (first 8h)     spontaneous intracerebral hemorrhage and assess a series of biological parameters (CBC,     glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI,     hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine     their input for early risk stratification and prognosis.   "
26719|NCT02935972|"     Prostate biopsy under transrectal ultrasound (TRUS) guidance is considered the procedure of     choice for diagnosing prostate cancer. And as in any other diagnostic biopsy procedures;     patients perceive anxiety before, during and after biopsy and ultrasound guided prostate     biopsy is not an exclusion.      TRUS guided prostatic biopsies are mainly performed in an outpatient clinic, men undergoing     transrectal prostate biopsy experience considerable psychological stress. It may be     attributable to the fear of the potential diagnosis of cancer, the anal route of penetration,     the fact that the subject organ examined is part of the sexual system and the anticipated     pain and as a matter of fact the issues of discomfort and pain perceived throughout the     procedure referred to the negative impact of the whole procedure, that is probe insertion and     biopsy punctures.      Thus it is essential to employ a simple method that can liberate the patient from pain during     prostate biopsy. Some studies recommend sedation , others recommend intra-rectal lidocaine     gel and others periprostatic nerve block while others recommend Nitrous oxide inhalation as     an effective method of analgesia for the procedural related pain or discomfort of prostate     biopsy. The employment of analgesics, sedation and/or narcotic medication may alleviate much     of the discomfort associated with transrectal prostate biopsy, such treatment may be     associated with additional risks. Furthermore, when systemic medication is administered,     patients require conscious sedation monitoring during and after the procedure, which may be     inconvenient and relatively expensive in addition to their unsuitability to be performed on     outpatient clinic basis. Therefore, a simple form of anesthesia is desirable.      Although a wide variety of anesthetic techniques are available for transrectal     ultrasound-guided prostate biopsy, including rectal administration of lidocaine gel,     periprostatic nerve blocks, intravenous propofol, and narcotic intramuscular premedication,     these methods may not optimally prevent or relieve pain.   "
26720|NCT02935959|"     Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized     midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children     undergo bone marrow aspirate and biopsy.   "
26721|NCT02935946|"     A previous study revealed that dysphagia preterm infants show statistically significant     improvements in their swallowing mechanism when fed cold liquid barium when compared to room     temperature liquid barium. The previous study was the first to identify these positive     effects, although, only assessed 5 cold liquid swallows, immediately after the room     temperature condition. This limited data set restricts the efficacy and safety of using cold     liquids in clinical practice, emphasizing the need for further information. The present study     aims to objectively assess the influence of cold liquid on the pharyngeal swallow mechanism     in preterm infants with dysphagia after 10 minutes of a cold liquid feeding. The     investigators will utilize videofluoroscopic swallow studies (VFSS) to analyze the frequency     and severity of pharyngeal swallowing deficits during room temperature swallows and compare     it to cold liquid swallows at various time points within a 10 minute feeding. Safety measures     will also be obtained, such as participant axillary body temperature and gastric content     temperature, to identify indicators for the development of cold stress.   "
26722|NCT02935933|"     Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could     improve the analgesic effect and thus reduce postoperative morphine consumption and     development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients     undergoing major breast cancer surgery, i.e., modified radical mastectomy (MRM) and breast     conservation surgery with axillary lymph node dissection.   "
26723|NCT02935920|"     Background:      In February 2015 the Danish Health and Medicines Authority published new clinical guidelines     describing how cancer patients should be followed. It is recommended that patients receiving     specific oncological treatment such as endocrine therapy be followed at the department of     oncology responsible for the treatment and providing the medication. There is no evidence     that routine examinations improve overall survival after breast cancer. Mammography is the     only specific examination to be offered to asymptomatic women after treatment for breast     cancer      Aims of the study:      The hypothesis is that individualized follow-up with the introduction of Patient Reported     Outcome (PRO) data will help postmenopausal women regain control of health related self-care     and encourage them to a larger extent to take part in their follow-up after cancer treatment.     This is believed to improve the health related quality of life and increase the positive     experience of the follow-up program.      Design:      Patients are randomly assigned to the department's standard control program or an     individualized solution in the context of shared decision making. PRO data will be used to     evaluate the patient's need for consultations.      Primary outcome:      Evaluation of the experience and feasibility of PRO data in connection with individualized     follow-up of postmenopausal women with breast cancer. Systematically applying PRO data we     will uncover patient needs, empower the patients to take part in shared decision making, and     improve the current follow-up in the sense of a more patient-centered care and tailored     follow-up.   "
26724|NCT02935907|"     APG-115 is a novel, orally active small-molecule mouse double minute 2 homolog (MDM2)     inhibitor. Mechanistically, APG-115 increases p53 and p21 overexpression, activates p53 -     mediated apoptosis in tumor cells retaining wild-type p53. APG-115 has shown strong dose- and     schedule-dependent antitumor activities in multiple human cancer xenograft and a patient     derived xenograft (PDX) models. The preclinical data generated from APG-115 suggest that it     may have a broad therapeutic potential for the treatment of human cancer as a single agent     and in combination with other classes of anticancer drugs. APG-115 is intended for the     treatment of patients with advanced solid tumors and lymphomas. Upon completion of the Phase     1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting     toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will     be implemented accordingly.   "
26725|NCT02935894|"     The purpose of this study is to see what the differences are in sweat (amount and small     molecule content) collected from different sites of the body and by different methods of     sweat stimulation. Additionally, the investigators want to know whether the amount and small     molecule content of the sweat is the same in an individual over time, and the same across     individuals at a given time. Finally, the investigators want to know how consumption of     over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory     mediator content of sweat and how that compares to blood. This information will help to     better understand the composition and behavior of sweat and assess its potential utility as a     routine clinical tool in skin research.   "
26726|NCT02935881|"     Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the     quality of life of patients. It may also lead to several complications like peptic     strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus.     Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients     with reflux disease becoming asymptomatic while taking PPIs. Several studies have     demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta     procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators     propose to perform a sham-controlled randomized study to evaluate the influence of the     Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.   "
26727|NCT02935868|"     Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence,     extension and severity. Periodontal disease is considered the sixth complication of diabetes.     There is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes     in younger patients. Thus, the aim of this observational study was to evaluate the     periodontal and salivary condition of a sample of patients with type 1 diabetes of a     brazillian city.   "
26728|NCT02935855|"     Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of     non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and     with vitamin K oral anticoagulants.   "
26729|NCT02935842|"     Due to Parkinson's Disease (PD) speech and language (SL) deficits may occur. Further, the     literature reports that PD patients, who have not undergone deep brain stimulation (DBS),     have deficits regarding voice quality (e.g. loudness and intelligibility of their voice),     while PD patients who have undergone DBS suffer from deficits in word retrieval and speech     apraxia symptoms. To-date, therapeutic approaches focusing specifically on SL deficits     observed in PD-DBS patients are yet to be developed and evaluated.      Therefore, this study investigates the short-and longterm effectiveness of specific and     intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared     to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training     (rBMT)) as well as to a 'no-therapy' condition.   "
26730|NCT02935829|"     This study investigated any potential associations between two preloads offered as snacks and     postprandial glycemic response, subjective and objective appetite and energy intake in     healthy, normal-weight adults.   "
26731|NCT02935816|"     The investigator prospectively compare diagnostic concordance of whole body     multi--‐parametric Magnetic Resonance Imaging (MRI) with current conventional     multi--‐modality reference standard imaging (CT scan, isotope bone scan +/--‐ PET--‐CT scan)     for staging of prostate cancer patients with biochemical relapse following external beam     radiotherapy or brachytherapy of locally advanced prostate cancer.   "
26732|NCT02935803|"     An increasing number of specific procedures have been described for the surgical repair of     pelvic organ prolapse (POP) and concomitant stress urinary incontinence (SUI). The     investigators introduced an alternative operative method for POP-Q II-III repair and     anti-incontinence with the trans vaginal mesh (TVM) anterior edge fixed to the periurethral     tissues at the level of mid-urethra. The efficacy and short- and long-term complication     profile, of this new surgical technique as compared with those of non-modified TVM.   "
26733|NCT02935790|"     Determine the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose     (MTD), and recommended Phase 2 dose (RP2D) of ACY-241 in combination with ipilimumab and     nivolumab in patients with unresectable Stage III/Stage IV melanoma.   "
26734|NCT02935777|"     The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a     two week intervention after a pre-intervention registration and preparation period.      This study explores whether acute supplementation with pomegranate extract can modulate     indicators of cognitive function and mood in healthy adults. Changes in physiological and     biochemical markers are also investigated.   "
26735|NCT02935764|"     This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan     monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.   "
26736|NCT02935751|"     The ADIOS study is a prospective, observational study will evaluate one hundred and thirty     (130) patients with non-valvular atrial fibrillation who are currently receiving treatment     with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who require     an elective major surgical or invasive procedure will be included in the study. The purpose     of the study is to evaluate the efficacy of the recommended pre-procedure washout period of     48 hours.   "
26737|NCT02935738|"     Corticosteroids have been indicated to treat men with ASAs. Although many studies have     confirmed the clinical therapeutic significance of corticosteroids in the treatment of men     with ASAs, other studies have not found a therapeutic significance for corticosteroids in the     treatment of men with ASAs. Moreover, although some reports have shown high fertilization and     conception rates in couples when husbands did not have ASAs, other reports have shown that     ASAs do not have a negative effect on fertilization and conception rates. These contradictory     results have left the therapeutic effect of corticosteroids in men with ASA in continuing     controversy. This controversy is also extended to include the usefulness of assisted     reproductive technology (ART) in the treatment of patients with ASAs. In this regard,     although some studies have shown that the pregnancy rate following in vitro fertilization     (IVF) or intracellular sperm injection (ICSI) were similar in men with or without ASA or did     not associate with ASA, others reported the superiority of ICSI over IVF and intrauterine     insemination over natural intercourse in men with ASAs. It is possible that some patients     with ASAs also have an additional problem(s) related to sperm binding to the oolemma and     fusion into the ovum as well as sperm head decondensation. The latter condition may     negatively influence or mask the clinical significance of corticosteroids on pregnancy rates     in patients with ASAs. Some patients might not have benefited from corticosteroids and     conventional IVF treatments due to the impaired sperm fusogenic capacity in addition to ASAs.     Human sperm penetration assay (SPA), of the hamster oocyte free from zona pellucida, is a     sensitive tool that can address such potential impairment of sperm binding with the oolemma     and fusion into the oocyte as well as sperm head decondensation. Males with poor SPA results     benefit from ICSI whereas those with good SPA results can still benefit from conventional     IVF.      The present study was therefore conducted to address the therapeutic usefulness of a     corticosteroid named prednisolone in the treatment of immunologically infertile men     undergoing IVF or ICSI determined by SPA.   "
26742|NCT02935673|"     The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK     model derived from healthy volunteers in hospitalized adults who are infected with     respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with     respiratory syncytial virus (RSV) infection the dose response relationship of multiple     regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative     real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.   "
26743|NCT02935660|"     Mult-center study to evaluate the safety and efficacy of an investigational version of the     Cutera enlighten laser that offers multiple wavelengths for tattoo removal   "
26744|NCT02935647|"     This study is designed to determine if the antidepressant effects of deep anesthesia via     propofol are related to EEG burst suppression.   "
26746|NCT02935621|"     The central aim of this proposed study is to test a multimodal, mindfulness-oriented     intervention designed to disrupt the risk chain leading to prescription opioid dose     escalation, opioid misuse and opioid addiction, which are mounting threats to active duty     service members and Veterans with chronic pain conditions, who may develop disordered opioid     use as a consequence of long-term opioid pharmacotherapy.   "
26747|NCT02935608|"     The primary objective of the study is to evaluate the efficacy of two dose regimens of     BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR).     Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional     neuropathic pain measures and assessments of low back pain, disability, and quality of life;     To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize     the pharmacokinetics (PK) of BIIB074 in this population.   "
26748|NCT02935595|"     The present proposal aims to combine state-of-the-art integrated transcranial brain     stimulation, electroencephalographic recording techniques with genetics and computational     modeling to unveil the mechanisms underlying a fundamental cortical network process -     synchronization of neuronal activity in the gamma band (30-80 Hz) - and the sources of its     intersubject variability. By measuring the entrainment of prefrontal cortex produced by weak     oscillatory currents, the study team will provide a new non-invasive strategy to derive     robust estimates of the cortical ability to support gamma oscillations, critically overcoming     limitations associated with current approaches and allowing measures solely dependent on     intrinsic regional cortico-thalamic properties. Consistent with molecular evidence and the     investigators biophysical models of gamma oscillations, the study team expects that such     unambiguous measurement of cortical capabilities will straightforwardly map onto key genetic     underpinnings related to the dopamine and neuregulin signaling pathways. These computational     models will be used to offer critical mechanistic insights linking genetic variations to     variability in emergent circuit-level activity in the form of cortical gamma oscillations.   "
26749|NCT02935582|"     Multinational real-life study of current psoriasis treatment strategies, topical treatment     patterns and treatment outcomes of these treatments, including the newly introduced     calcipotriol/betamethasone dipropionate aerosol foam fixed combination product Enstilar®     (calcipotriol/betamethasone dipropionate).   "
26750|NCT02935569|"     This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression     headband will decrease the percentage of patients with significant hair loss following     radiation.   "
26751|NCT02935556|"     This study will recruit women with post partum pre-eclampsia and match them to controls     without postpartum pre-eclampsia to identify an epigenetic signature that is specific to     women with post partum pre-eclampsia to help characterize the underlying pathophysiology of     post partum pre-eclampsia.   "
26752|NCT02935543|"     This is a single center, single arm, open-label phase 2 study to determine the efficacy of     autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and     4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART19 cells) in adults with     minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic     leukemia.   "
26753|NCT02935530|"     Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality     in women undergoing surgery for gynecologic malignancies. Although the benefit of     thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic     cancers has been well documented around the world, the evidence for Chinese women is rare.     The investigators designed this prospective and randomized study to assess the benefit of     pharmacologic prophylaxis for patients received surgical treatment for gynecologic     malignancies in China.   "
26754|NCT02935517|"     This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of     AGTC-402, administered to one eye by subretinal injection in individuals with achromatopsia     caused by mutations in the CNGA3 gene. The primary study endpoint will be safety and the     secondary study endpoint will be efficacy.   "
26755|NCT02935504|"     The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that     aims to improve women's access to and participation in perinatal depression treatment and     thereby improve depression outcomes   "
26807|NCT02934828|"     The investigators research aim to explores the optimal comprehensive treatment for TNBC and     her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant     treatment in improvement of RFS.   "
26808|NCT02934815|"     To test the feasibility of supportive-expressive group intervention (SEGT) for women with     primary breast cancer and to provide a preliminary test of its efficacy.   "
26809|NCT02934802|"     This post-market clinical follow-up study intends to investigate the survival rate at 5 years     of the e.motion® PS Pro System.   "
26756|NCT02935491|"     Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an     alternative to conventional surgery for aortic stenosis cure. Despite a high rate of     procedural success, some patients do not benefit from the procedure. The investigators     hypothesis is that aortic stiffness may be of major prognostic significance after stenosis     relief.      The aim of this study is to test the prognostic impact of aortic stiffness estimated by the     volume of calcifications of the thoracic aorta on the CT-scan performed systematically before     the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4     french cities (Lyon, Rouen, Paris, Clermont-Ferrand).   "
26757|NCT02935478|"     Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a     grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not     candidates for liver transplantation, depriving them of the best option for cure from HCC.      Recent studies have shown that blocking blood vessels to a particular portion of the stomach     (bariatric or left gastric artery embolization) can temporarily decrease levels of the     appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to     determine if Left gastric artery embolization (LGAE) in patients with cirrhosis and HCC who     are not transplant candidates due to morbid obesity, leads to clinically significant weight     loss with eligibility for liver transplantation.   "
26758|NCT02935465|"     The overarching aim of this project is to conduct a randomized controlled study to determine     whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve     pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be     governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back     pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.   "
26759|NCT02935452|"     The Generating Engagement in Network Involvement (GENIE) Tool is designed to support people     to find and join social activities in their own neighbourhoods.      Evidence has shown that people with more social support have increased ability to manage long     term conditions and ill health.      Patients with Chronic Obstructive Lung Disease (COPD) have difficulty breathing every day;     this is both tiring and makes its difficult to socialise as they did prior to having their     condition. COPD can be managed with medicines, and exercise, but will never be cured, so it     is considered a 'long term condition.'      This study plans to use a social mapping tool (GENIE) with COPD patients that are already     part of the community service. The aim of the study is to increase opportunities to socialise     and get day to day support outside of the health service.      Patients will be offered either the tool, or usual care.      If the study is successful then use of health care may reduce in the COPD patients already     using the COPD service.   "
26760|NCT02935439|"     The purpose of this research study is to learn about the use of a cell phone for monitoring     patients with heart failure. Participants will be asked questions about their heart failure     daily and participants will need to answer them. The investigator will try to assess if the     questions are easily understood by the participants. The investigator will also assess if the     phone-based system for monitoring is easy to use by the participants. The investigator will     also assess if the daily questions and interactions increase the self-efficacy, knowledge,     and quality of life of participants related to their heart failure.   "
26761|NCT02935426|"     Cyanoacrylate tissue adhesives have been successfully used for wound closure. The purpose of     this clinical trial is to compare cyanoacrylate tissue adhesives to polytetrafluoroethylene     (PTFE) sutures in the donor site of connective tissue grafts. Two groups of volunteers will     randomly assigned to one of the two study groups. The wound closure at the palatal donor area     will be achieved with polytetrafluoroethylene (PTFE) sutures in one group and with high     viscosity cyanoacrylate tissue adhesives on the other group. The surgical procedure will be     performed by one of three calibrated periodontics residents. Data will be collected at     baseline-day of the surgery and in one week post-operatively. The primary outcome is     patient's discomfort from the donor site during the first week after the surgery. Secondary     outcomes is the time required for suture placement or cyanoacrylate application, patient's     pain from donor and recipient site one week post-operatively, painkillers intake, presence or     absence of inflammation and modified EHI early-wound healing index.   "
26762|NCT02935413|"     The purpose of this Study is to determine whether non-invasive transcranial direct current     stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual     Cortex.   "
26763|NCT02935400|"     The long term objective of the research is to identify new biomarkers of disease activity in     the human acute porphyrias. This pilot study is intended to provide pilot and feasibility     data needed to plan larger and more definitive future studies.   "
26764|NCT02935387|"     Rheumatoid arthritis (RA) patients in remission with a combination of TNFinhibitors (TNFi)     and methotrexate (MTX) often express their wish to stop MTX treatment because of side     effects. Given the efficacy of TNFi it is conceivable that in early RA patients in remission     with methotrexate (MTX)/TNFi stepwise discontinuation of MTX prior to TNFi is superior in     maintaining sustained remission and reaching drug free remission as compared to     discontinuation of TNFi prior to MTX.      Objective: To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more     efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free     remission.      Study design: multicenter, open label clinical trial in very early RA patients. Remission     will be induced by an open label treat-to-target (T2T) remission induction protocol in     clinical care: (MTX, hydroxychloroquine (HCQ), i.m. glucocorticoids (GC), and, if not in     remission, the TNFi golimumab (GOL)) (phase I, 3/4th or 1 year). Patients in sustained     remission on MTX/GOL (DAS28<2.6 with max 4 swollen joints of the 44 swollen joint count (SJC)     at 2 consecutive visits 3 months apart) will be randomized to taper either MTX first, then     GOL or GOL first, then MTX with as primary endpoint sustained (drug free) remission (phase     II, 1 year). During 1 year additional follow-up maintenance of drug-free sustained remission     will be investigated (phase III).      Study population: RA patients fulfilling 2010 American College of Rheumatology (ACR)/EUropean     League Against Rheumatism (EULAR) criteria for RA, with symptom duration <12 months; naïve     for anti-rheumatic drugs and glucocorticoids for RA; DAS28 ≥3.2.      Intervention: Patients in sustained remission (defined as DAS28<2.6 with max 4 swollen joints     of the 44SJC at ≥ 2 consecutive visits 3 months apart) on MTX/GOL at the end of phase I     (after 24 weeks of treatment with MTX/GOL) will be randomized in a ratio of 1:1 to taper     medication as follows:        -  Taper and stop GOL first during 24 weeks, then, if still in sustained remission, taper          and stop MTX during 24 weeks        -  Taper and stop MTX first during 24 weeks, then, if still in sustained remission, taper          and stop GOL during 24 weeks The primary end point is the proportion of patients in          sustained remission at week 24 after start of tapering of either MTX or GOL first. The          main secondary end point is the proportion of patients in drug-free sustained remission,          at week 48 after start of tapering.   "
26765|NCT02935374|"     This is a randomized, controlled trial studying the effects of various antimicrobial     treatments on the intestinal microbiome of small children. The participating children with     acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without     antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they     will be monitored as a separate group. The main outcomes of this trial are the changes in the     intestinal microbiome after the treatment.   "
26766|NCT02935361|"     This phase I/II trial studies the side effects and best dose of guadecitabine when given     together with atezolizumab and to see how well they work in treating patients with     myelodysplastic syndrome or chronic myelomonocytic leukemia that has spread to other places     in the body and has come back or does not respond to treatment. Guadecitabine may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as atezolizumab, may interfere with the ability of cancer cells to grow and     spread. Giving guadecitabine and atezolizumab may work better in treating patients with     myelodysplastic syndrome or chronic myelomonocytic leukemia.   "
26767|NCT02935348|"     Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations     including a separate PET and MRI scans during their treatment.      Investigators want to investigate if a combined PET-MRI scan could give the same information.      Children who join our study will have an extra scan twice during their treatment   "
26768|NCT02935335|"     AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims     to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a     fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for     infertile women undergoing their first IVF/ICSI cycle in the current practice.   "
26769|NCT02935322|"     The aim of the present study was to study if there are interactions and reduced clinical     effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.   "
26770|NCT02935309|"     This research study is designed to see if Capecitabine and Lenvatinib in combination with     external radiation therapy are effective in treating locally advanced rectal adenocarcinoma     in patients who have not yet had surgery, and what the best dosage is.   "
26771|NCT02935296|"     The purpose of this study is to determine the feasibility of a future trial that will assess     whether an integrated intervention combining psychosocial counseling and supported referrals     for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for     HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected     injection partners, as compared to routine care dictated by national guidelines for     HIV-infected PWID.   "
26772|NCT02935283|"     In proximal urea cycle disorders (UCD), particularly ornithine transcarbamylase deficiency     (OTCD), hyperammonemia (HA) causes increased brain glutamine (Gln) which perturbation is     thought to be at the core of the neurological injury. In contrast, in distal UCD such as     citrullinemia (argininosuccinate synthetase deficiency; (ASSD) and argininosuccinic aciduria     (argininosuccinate lyase deficiency); (ASLD) cognitive impairment and neuropsychiatric     disease are common even in the absence of acute HA. As a consequence, both citrulline and     argininosuccinate (ASA) or their metabolic products have been implicated as neurotoxic. In     this project the investigators will use state-of- the-art neuroimaging and neuropsychological     methods to investigate whether patients with OTCD have chronically elevated brain Gln and     reduced myo-inositol (mI) levels that correlate with regional brain structural abnormalities     and neurocognitive dysfunction. The researchers will further investigate whether during an     acute episode of HA elevated brain Gln and decreased mI levels correlate with the magnitude     of cytotoxic edema and whether a Gln/mI ratio threshold can be identified at which the     cytotoxic edema is followed by cell loss. Finally, the researchers will investigate whether     regions of brain damage in ASSD and/or ASLD are distinct from those in OTCD and compare brain     Gln levels in ASSD and ASLD in the absence of HA to those in OTCD. The investigators will     also seek to determine if brain citrulline and ASA can be identified in the brains of     patients with distal UCD and whether they correlate with brain abnormalities seen in MRI and     neuropsychological testing. This project will elucidate the chronology of brain pathology     both in acute hyperammonemia and chronic UCD and whether, proximal and distal UCD differ in     their pathophysiology of brain damage.   "
26773|NCT02935270|"     The purpose of this study is to examine measurement of unilateral neglect post stroke.     Although a number of clinical assessments are used to measure neglect, it is unclear whether     items from some of the most commonly used assessments are able to effectively and     comprehensively measure neglect. This study will determine whether these assessments measure     different aspects of neglect and whether items from various neglect assessments can be     combined to more effectively measure neglect.   "
26774|NCT02935257|"     This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced     Therapy Investigational Medicinal Product (ATIMP) in adults (age 16 to 65 years) with high     risk, relapsed/refractory CD19+ B-ALL. The ATIMP for this study is cryopreserved autologous     patient-derived T-cells transduced with a lentiviral vector to generate the CD19CAT-41BBZ CAR     T-cells (referred to subsequently as CD19CAR T-cells). Patients will undergo an unstimulated     leucapheresis for the generation of the ATIMP which will take approximately 15 days to     generate. During this period, patients may receive holding chemotherapy as per     institutional practice to maintain disease control. Patients will receive pre-conditioning     lymphodepleting chemotherapy with cyclophosphamide 60mg/kg on Day -6 and fludarabine 30mg/m2     administered over 3 days (Day -5 to Day -3).      The study is designed as an intra-patient dose escalation employing a total dose range (over     2 doses, Dose 1 and Dose 2) of between 5 x 106 CD19CAR T-cells and 1.1 x 109 CD19CAR T-cells.     The study will evaluate ATIMP safety and efficacy and the duration of disease response in     adults with high risk / relapsed CD19+ B-ALL.      After completing the interventional phase of the study all patients, irrespective of whether     they progressed or responded to treatment, will enter long term follow up until 5 years     post-CD19CAR T-cell infusion.   "
26775|NCT02935244|"     ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical     patients, which aims to determine the incidence of healthcare-associated S. aureus     infections, particularly S. aureus surgical site infections (SSIs), across Europe and to     assess the most important risk factors for this type of infection.   "
26810|NCT02934789|"     This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas     using the Truclear hysteroscopic morcellator compared to women managed medically. Study     population includes women age 18 and older with symptomatic submucosal myomas. Patients will     be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life     Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.   "
26811|NCT02934776|"     The purpose of this study is to examine if investigators can improve diagnosis of prostate     cancer by using MRI/DTI?   "
26901|NCT02933606|"     This is a randomized, double-blind, placebo-controlled study, evaluating the effects of     BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the     Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).      The secondary objectives of the study are to evaluate the effects of BNC210 on anxiety,     depression, global functioning and patient reported outcomes in patients with PTSD. Safety     and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks of     blinded treatment followed by a 3 week follow-up period.   "
26776|NCT02935231|"     Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the     first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not     seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor     place where smokers stop/linger and smoke. We aim to include a reasonably representative or     unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will     randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous     community trial.      Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced     research assistant) will be deployed for each session of intervention at a SH. Potential     subjects will be approached using the a-foot-into-the-door method in which SC ambassador     will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices.     Smokers will be assessed for eligibility and informed written consent will be sought.     Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To     reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact     number of the trial into subjects' mobile phones.      Discussion: The findings will provide much needed and original evidence to support a main RCT     on these new, proactive, simple and low-cost interventions for improving current SC services     and policy for smokers who do not actively seek help from SC services in Hong Kong and     elsewhere.   "
26777|NCT02935218|"     N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years)     participated in a 12-week training program. To estimate the participants' impairment,     parental stress and psychological distress were assessed before the training. After the     training, participants and trainers were asked to provide feedback regarding the valuation of     and the changes due to the training.   "
26778|NCT02935205|"     This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see     how well they work in treating patients with prostate cancer that does not respond to     treatment with hormones, has come back, or has spread from where it started to other places     in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using     enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen     the body makes and/or blocking the use of androgen by the tumor cells.   "
26779|NCT02935192|"     A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent,     split, inactivated influenza vaccine produced by Torlak.   "
26780|NCT02935179|"     The purpose of this project is to use white-skinned sweet potato as the main material for     weight control for overweight and obesity, the non-communicable diseases (cardiovascular     diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high     quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and     health food that to do functional study in Shih Chien University and Taipei Medical     University. In this study, the investigators will recruit overweight and obesity subjects     that divide into white sweet potato group (experimental group) and no intervention group     (control group) by using randomized, parallel and open clinical study in sixty days.   "
26781|NCT02935166|"     Respiratory muscle weakness and fatigue are related to clinical deterioration in patients     with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key     therapeutic strategy in these patients. It is necessary therefore to increase its     dissemination on a large scale, improve patient´s adherence and optimize the control of the     implementation of training. The aim of this project was to design a RMT device including     light and sound incentives, digital registration application and analysis of the training     sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that     could provide added value to enhance the implementation of training in patients with COPD.     From an operational point of view, researches were organized into three packages of     complementary work focused on the design of a new portable dual valve with electronic     lighting and auditory incentives components. The conceptualization and design of a software     to analyze the performance and individual continuous use of the valve, and the evaluation of     the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training     in adult patients with COPD were realized.   "
26782|NCT02935153|"     The overall purpose of this study is to explore the therapeutic effect of CD22-targeted     chimeric antigen receptor T(CAR-T) cells in the treatment of Malignant B-cell Derived     Leukemia and Lymphoma.   "
26783|NCT02935140|"     Many children who are born medically fragile due to prematurity, multiple congenital     abnormalities or an acquired insult (i.e. cardiac, neurologic, etc.) may require tracheostomy     tube placement due to need of chronic respiratory support. Patients on tracheostomy tubes are     often unable to vocalize, causing a delay in speech development and poor speech. To help     restore normal phonation and promote language development in young pediatric patients with     tracheostomies, speaking valves are used. Previously it was shown that the Passy-Muir     speaking valve was safe to use during sleep in children by showing there were no adverse     cardiopulmonary events seen. One objective measurement that was not evaluated was     trans-tracheal pressure manometry. The purpose of this study is to continue to validate the     safety of the Passy-Muir speaking valve while asleep, with the use of trans-tracheal     manometry by comparing expiratory pressure manometry while the patient is awake and asleep.   "
26784|NCT02935127|"     Absorbable sutures are not generally accepted by the majority of vascular surgeons for the     possible complications such as the breakage of the suture at the anastomoses level. Some     experimental and clinical studies in the current literature demonstrated that the use of     absorbable sutures may even reduce some important complications such as restenosis.      The aim of this study is to compare absorbable and non-absorbable sutures in patients     undergoing peripheral vascular surgery with vein bypass grafting.   "
26826|NCT02934581|"     A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were newly     admitted to the medical intensive care units and turned out to be diagnosed as Obesity     hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence,     predictive factors, and outcomes of OHS in these critically ill patients.   "
26827|NCT02934568|"     This study is to allow continued use of ribociclib (LEE011) as single agent or in combination     with other investigational treatments in patients benefitting from treatment in an eligible     Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has     been halted for other reasons.   "
26828|NCT02934555|"     To study the effects of ubiquinol as a metabolic resuscitator in post-cardiac arrest.   "
26785|NCT02935114|"     Objectives: This study will determine the clinical efficacy of bleaching agent 37% carbamide     peroxide compared to 35% hydrogen peroxide on the change of color scores in anterior superior     teeth, in-office bleaching technique after 7, 14 and 37 days; and the Risk to the tooth     sensitivity before, during and 24 hours after the procedure.      Materials and Methods: Fifty patients will be selected for this single-blind, parallel,     randomized-controlled clinical trial. The whitening treatment with 37% carbamide peroxide or     35% hydrogen peroxide (control) will be carried out in a single application of 45 minutes for     two sessions with a 7-day interval. The sensitivity level will be assessed before, during and     24 hours after the procedure using verbal and analogic visual analogue (VAS) scales. Color     alteration will be assessed by a bleach guide scale 7 days after each session and 30 days     after the last session. Relative risk to sensitivity will be calculated and adjusted by     session; while comparison of overall risk will performed by McNemar's test. Data on the     sensitivity level for both scales will be subjected to the Mann-Whitney tests (α = 0.05). The     color change will be measured with a spectrophotometer using the CIE L * a * b * and the L*,     a * and b * parameter delta data, and ΔE and Δ00, will be individually subjected to two-way     repeated measures ANOVA test to compare the two bleaching techniques at each evaluation time     (α = 0.05).   "
26786|NCT02935101|"     The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency     of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or heroin.   "
26787|NCT02935088|"     The purpose of this study is to understand routine use of FFR and alternate indices in     clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI     in patients presenting with either stable coronary artery disease, or in patients presenting     with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index     and secondary procedures.   "
26788|NCT02935075|"     The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However,     synergy among these drugs has not been well considered. The dose of drugs used as monotherapy     is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the     first line regimen of cART in developing countries. The side effects of these drugs are     related to the concentration of drugs. Based on our previous data, we aim to evaluate whether     reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects     while not scarifying their virological efficacy.   "
26789|NCT02935062|"     The aim of this study is to compare phonological and auditory aspects of children submitted     to traditional phonological therapy, phonological therapy using a software and placebo     therapy in children with phonological disorders.   "
26790|NCT02935049|"     For tough colic resection, evaluation of our practice for these lesions unresectable in     monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy     dissection) /ESD (submucosal dissection)   "
26791|NCT02935036|"     Safety and efficacy study in patients with acne vulgaris   "
26792|NCT02935023|"     The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT)     treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The     primary objective: to determine disease biochemical progression-free survival in man with     oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive     radiotherapy of the primary tumor. The secondary objective: to determine local control,     overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing     carbon ion radiotherapy   "
26793|NCT02935010|"     With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric     eradication regimens in the mainland of China, tailored therapy may be the best choice to     achieve good efficacy. This study compared the eradication rates, safety, and compliance of     antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy     in the naive patients with Helicobacter pylori infection.   "
26794|NCT02934997|"     To determine the role of dysfunctional high density lipoprotein (Dys-HDL) in predicting or     mediating progression to chronic critical illness or morbid long-term outcomes in patients     being treated for community-acquired or hospital-acquired sepsis.   "
26795|NCT02934984|"     The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA)     can help early screening of pancreatic cancer recurrence or not. And we are also planning to     evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.   "
26796|NCT02934971|"     The present project will develop an automated machine learning approach using multi-modality     data (imaging, laboratory, electrocardiography and questionnaire) to increase the     understanding and prediction of arising heart failure in patients scheduled for cardio-toxic     chemotherapy. This algorithmus will be developed by the technical cooperation partner at     Technion, the institut for biomedical engineering in Haifa, Israel.   "
26797|NCT02934958|"     We plan to study whether the impact of offering the choice of a pre-colonoscopy physician     visit or direct referral to colonoscopy will increase adherence to colonoscopy relative to     usual care in a large fecal immunochemical test (FIT) mailing campaign.      We will evaluate two study options, usual care during which patients will be required to have     an office visit with wither a PCP or a Gastroenterologist prior to being scheduled for a     colonoscopy, or a choice where patients will be given the option of a pre-colonoscopy visit     with a gastroenterologist or PCP vs. direct referral for a colonoscopy.      In these two options we will examine colonoscopy adherence, adequacy of triage, patient     satisfaction, colonoscopy outcomes (no show rate, prep quality, and pain during colonoscopy)     and how insurance coverage, gender, race, education or patient understanding of colon cancer     screening message during the navigation process might impact outcomes.   "
26829|NCT02934542|"     The objective of this study is to evaluate the ability to reduce the number of OR personnel     required while performing the following procedures: colon resections, anti-reflux/hiatal     hernia surgery with the AutoLap system compared with the standard operation.   "
26839|NCT02934412|"     This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5     sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose     levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of     6 subjects receiving active drug and 2 subjects receiving placebo, for a total of     approximately 40 subjects dosed at one study site.   "
26798|NCT02934945|"     Bronchial asthma is a common respiratory disease characterized by chronic airway     inflammation, which have been affecting about 1-18% of the population in the world, causing     tremendous economic burden for the patients and countries. Generally, asthma is a     heterogeneous disease, and it could be classified into many types on the basis of symptoms,     that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc.     Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such     as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow     limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is     characterized by the single manifestation, recurrent cough, which could be improved after the     use of bronchodilators. However, according to different guidelines, it is still controversial     on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014     put forward the treatment of TA patients, but did not list the treatment specific to CVA. The     guideline of ACCP（American College of Chest Physicians） and cough guidelines of China are     proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids     (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently,     more and more studies supported that application of ICS combined with bronchial dilation     agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and     long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but     also be used as a relief medication, namely, budesonide/formoterol treatment regimen for     SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART     treatment can be used in the treatment of TA patients. But the study on whether     budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical     medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA     or CVA , who will be required to adopt the SMART regimen in the following 6 months.The     symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be     measured every mouth. After the study finished, the investigators will compare the difference     between the two groups.   "
26799|NCT02934932|"     Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in     resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron     target engagement in a group of subjects with PTSD. All subjects will be evaluated by     physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing,     and urinalysis. Results of these studies must demonstrate a lack of clinically significant     abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and     receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil     diameter during pupillometric evaluation after two weeks on each treatment will serve as the     primary outcome measure. This will be compared in the treatment groups using mixed effects     repeated measures models to evaluate if there is a significant difference in pupil size among     the treatments studied. As a secondary analysis this approach will be used to evaluate     whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will     compute correlations between pupil size and CAPS-5 scores.   "
26800|NCT02934919|"     Impulse control disorders (ICDs) (such as pathological gambling, hypersexuality, compulsive     shopping …) are an increasingly recognized psychiatric complications in Parkinson's disease     (PD). Therapeutic management of these disorders is important since they have an impact on     patient quality of life. Dopamine agonists play a key role in the emergence of ICD.      Animal models and imaging underline the implication of opioid system in the genesis of ICD.      An opioid antagonist, the naltrexone, has been studied to treat ICDs in PD. Papay and al 2014     have found that patients treated by naltrexone showed an interesting decrease of their ICDs     measured by the QUIP RScale. Nevertheless, naltrexone has shown adverse effects such as     increasing hepatic liver enzymes. Nalmefene has no known hepatic adverse effects. Nalmefene     is an opioid antagonist that has an antagonist action on μ and δ receptors, but also an     agonist action on κ receptor. Grant and al 2006 has shown significant reduction of the     severity of pathological gambling in patients treated with nalmefene.      The primary purpose is to evaluate the efficacy and the safety of nalmefene in the treatment     of ICDs in PD.   "
26801|NCT02934906|"     This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune     thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an     appropriate clinical screening procedure   "
26802|NCT02934893|"     The benefit of drug therapy to persons with diabetes has been well established in clinical     trials in terms of reducing cardiovascular risk, microvascular complications and mortality.     However, treatment adherence and treatment effectiveness continue to be challenges in     diabetes management.      Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic     medications on an individual's glucose profile, allowing the clinician and their patient to     visualize the anticipated outcome of a medical intervention. Use of this technology should     allow for more targeted decision-making by the clinician and should facilitate a shared     decision-making process with the PwD who is now privy to the thought process behind their     medical management.      The proposed study is designed to test whether adding a decision support capability     (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments     leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.   "
26803|NCT02934880|"     Breast cancer is the most frequent cancer in women in western countries. The improvement of     therapeutic management associated to the developement of supportive care allows patient to     live longer in better conditions. But several studies have showed the deleterious impact of     treatment such as chemotherapy on cognition. To limit these damages, non therapeutic     approaches such as Adapted Physical Activity (APA) have been developped.      The goal of this study is to evaluate the benefit of APA program on cognitive functions in     patients with locally advanced breast cancer.   "
26804|NCT02934867|"     Medical call center have no phone advice protocol within out of hospital cardiac arrest in     France. The purpose of the present study is to compare a group of patients with protocol     phone advice delivered by the dispatchers (CONTARM group) versus usual phone advice (     CONTHAB group). Comparison will be performed on survival to seven days. The hypothesis is     that CONTARM group has an higher survival at seven days. A second goal is to measure the     survival to 15 and 30 days. The trial is randomized, controlled and will include 2600     patients. The patients will be enrolled in 19 hospitals in France.   "
26805|NCT02934854|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of creatine     deficiency syndromes from plasma   "
26806|NCT02934841|"     The investigators hypothesize that it is safe and effective to treat patients with choroidal     neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis     with Conbercept.      This will be a randomized, placebo-controlled trial. 20 patients will receive three     injections of Conbercept into the affected eye (and repeated injections if required), and 20     patients will receive three sham injections requiring no needle stick, but making the patient     unaware of whether or not he received active treatment.      Outcome of the two treatment groups will be compared after one year.   "
26812|NCT02934763|"     Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy     volunteers and in animal models. Is defined as an increase in the perception to painful     stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli.      The apparition of OIH is also related to the exposure to opioids during surgery, depending of     the dose, the time of exposition and the type of opioid.      This condition can be modulated, specially in the perioperative context. It has been seen in     healthy volunteers and in animal models, than the use of propranolol can modulate this     phenomena, diminishing the postoperative requirements of analgesia. It is also unknown, the     dose of propranolol required to modulate adequately OIH.      The objective of this work is to evaluate the efficacy of propranolol in the modulation of     opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.   "
26813|NCT02934750|"     This randomized, cross-over study aims at describing the effect of pursed lip breathing on     exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.   "
26814|NCT02934737|"     Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will     be observed (if any). Anthropometric and biochemical parameters will be evaluated.   "
26815|NCT02934724|"     The overall aim of the study is to assess the effect of school-based Human Papillomavirus     (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and     non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year     of vaccine initiation of the 1997-cohort) are invited to participate in the study.   "
26816|NCT02934711|"     Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination     arrangements between professionals on the transformation of modes of exercise of professional     care, and on the experience of patients / users and that of caregivers, particularly on     dimensions constituted that the quality of care in order to build a coordinated exercise     structures rating scale primary care on the basis of criteria suggested by patients   "
26817|NCT02934698|"     This postmarketing N of 2 study is designed to evaluate the efficacy and safety of open-label     ivacaftor treatment in two sisters with cystic fibrosis and pancreatic sufficiency.   "
26818|NCT02934685|"     To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result     in disease-free survival (DFS) that is no worse than DFS following conventionally     fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized     prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom     from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the     incidence of GI and GU toxicity.   "
26819|NCT02934672|"     The primary objectives of the survey are to obtain patient preference information that can be     useful during the benefit-risk assessment of the KineSpring System.   "
26820|NCT02934659|"     The primary objective of this pilot study is to collect data on the safety and effectiveness     of the Atlas Knee System in subjects with medial knee osteoarthritis through 24 months     postoperative follow-up.   "
26821|NCT02934646|"     This is a phase-II clinical study to assess whether intense passive mobilization of the elbow     during the early stage is effective in preventing spasticity from occurring at a later stage.     A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module     (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was     assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.      Investigators expected that intense therapy performed in the sub-acute phase following the     stroke would be effective in preventing elbow spasticity from occurring at a later stage     (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified     Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke     rehabilitation, the present study will include only one group of patients. As a secondary     objective, similarly to other studies with robot-assisted therapy, investigators wiil test     the ability of this system to be used for assessing rehabilitation outcome. Investigators     will introduce novel evaluation metrics based on the kinematics and kinetics variables     recorded by the NEEM and compared them with MAS values.   "
26822|NCT02934633|"     This project completed an intervention designed to teach parents of children aged 0-2 years     of age how to prevent injuries to their child. The intervention consisted of a two DVD     package with information on creating a safe home environment and correctly choosing and     installing an appropriate car safety seat. The study hypothesis was that parents who used the     intervention would score significantly higher on measures of knowledge, motivation, intention     and self-efficacy in implementing injury prevention strategies.   "
26823|NCT02934620|"     Globally, women in established relationships remain at risk for unintended pregnancy and     sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the     proposed research, unmet need for contraception is substantial as reflected in the nation's     high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and     among this group, most were exposed to the virus through sexual activity with their husband.     Condoms will remain crucial for prevention for some time to come. Sustained condom use,     however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms     is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for     engaging in sex and is an integral part of overall sexual health, most programs to improve     sexual health operate within a pregnancy and disease-prevention paradigm. A new condom,     CSD500, containing an erectogenic drug was developed for use among healthy couples to improve     sexual pleasure by increasing penile firmness, size and erection duration. The overall     objective of the proposed two-arm randomized trial is to test whether promoting the novel     condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal     sex. Investigators will measure the occurrence of unprotected vaginal sex by testing women's     vaginal fluid for the presence of prostate-specific antigen (PSA), an objective, biological     marker of recent semen exposure. Investigators will randomize 500 adult, heterosexual,     monogamous couples in Thanh Hoa province, Vietnam to receive either CSD500 for sexual     pleasure or the standard condom currently provided only for pregnancy and disease prevention     to patients during routine care. Study staff will interview female participants at enrollment     and after 2, 4, and 6 months and their male partners at the 6-month visit. Study clinicians     will sample vaginal fluid from female participants at all visits to test for the presence of     PSA.   "
26824|NCT02934607|"     This study will be conducted to establish the relative bioavailability of budesonide and     formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and without a     spacer device.      Administration under each condition will occur with the concomitant administration of     activated charcoal to estimate exposure through the lung and without activated charcoal to     estimate total systemic exposure.   "
26825|NCT02934594|"     Patients with metastatic spinal cord compression (MSCC) are treated with different options     according to the life expectancy. Survival and surgical outcome can be influenced by surgical     timing in MSCC patients treated with palliative decompression.   "
26830|NCT02934529|"     The FIRE-4 study aims to define a treatment concept for patients with RAS wild-type tumours,     optimised with regard to overall survival. The first-line treatment will be conducted with     FOLFIRI plus cetuximab, which resulted in a significantly prolonged overall survival versus     bevacizumab in the FIRE-3 study. Following initial progression (PD1) it is recommended that     the treatment be continued with FOLFOX plus bevacizumab, as this concept led to significantly     prolonged survival in the E3200 study. Owing to the encouraging results of the Santini study     , a cetuximab rechallenge in combination with irinotecan-based chemotherapy is to be     performed as part of the third-line treatment in patients who showed a response defined     according to RECIST 1.1 during the first-line treatment (tumour diameter < -30%) or presented     with stable tumour disease for at least 6 months (tumour diameter +20 to -30%). The concept     of the ideal sequence has not yet been studied to date in a clinical trial.   "
26831|NCT02934516|"     The study aims to compare maternal and early neonatal outcomes of abdominal disimpaction with     lower uterine segment support in comparison to the classic push method for delivery of     impacted fetal head during Cesarean section for obstructed labor.   "
26832|NCT02934503|"     This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with     or without radiation therapy in patients with small cell lung cancer (SCLC).   "
26833|NCT02934490|"     The study is to explore the effectiveness of a new-style anterior vaginal wall mesh in the     treatment of female stress urinary incontinence(SUI). Meshes were made by Gynemech TM PS,     (Johnson & Johnson Shanghai Medical Equipment Co. China Food and Drug Administration (CFDA)     registration No. 3460365, size 10 × 15cm). Meshes were cut to appropriate size. The     incontinence questionnaire summary table (ICIQ-SF), pad test, urodynamic and other diagnostic     tests were used for preoperative assessment and the evaluation of postoperative surgical     outcome and complication. The results were compared with the one-year cure rates of Burch and     trans vaginal taping (TVT) surgeries. The analysis indicated that the surgery using the     new-style anterior vaginal mesh, as a minimally invasive procedure, not only achieved its     expectation with similar cure rate to Burch, TVT/ trans vaginal taping obturator (TVT-O)     surgeries, but also has lower economic cost and complication rate than the TVT /TVT-O     approach. The evaluation of long-term treatment effect needs further follow-up of the     patients.   "
26834|NCT02934477|"     This observational study will compare outcomes of a prospectively-enrolled cohort of     Hematopoietic Stem Cell Transplant (HCT) recipients with outcomes of a cohort of age-matched     historical non-HCT controls. Patients undergoing alloHCT will receive HCT in a US transplant     center and be reported to the Center for International Blood and Marrow Transplant Research     (CIBMTR) using well-established CIBMTR report forms and data collection procedures as well as     a study-specific supplemental form. Data on the historical non-HCT controls will be collected     at 14 US academic centers. These centers will provide data on all consecutive patients with     PMF, post-ET MF, or post-PV MF referred to their institutions between 2000 and 2012.   "
26835|NCT02934464|"     This is a randomized, open-label, multicenter phase III trial of ramucirumab plus paclitaxel,     given as switch maintenance, versus continuation of first-line chemotherapy, given as per     standard clinical practice, in subjects with unresectable locally advanced or metastatic     HER-2 negative gastric or GEJ cancer, without disease progression following 3 months of     first-line doublet chemotherapy.      The acceptable first-line or lead-in chemotherapy will be:        -  FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2. Cycle          length is 2 weeks +/- 3 days.        -  ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400          mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days.        -  XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is          3 weeks +/- 3 days.   "
26836|NCT02934451|"     Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily.     Individuals with osteogenesis imperfecta break bones often and may have other problems,     including hearing loss and pain and difficulty getting around. People with moderate to severe     OI may also be diagnosed with dentinogenesis imperfecta (DI). DI is characterized by grey or     brown teeth that may chip and wear down and break easily. People with DI may also have skull     and neck defects. These patients may have severe teeth misalignment resulting in clinically     significant chewing problems. Teeth misalignment in OI is very hard to treat because of the     quality and quantity of bone. The overall goal of this study is to improve dental health to     improve the quality of life of people with OI.   "
26837|NCT02934438|"     Reduced nitric oxide (NO) availability is a hallmark of a number of cardiovascular diseases     (CVD) including peripheral artery disease (PAD). The investigators will test the hypothesis     that sub-chronic NEO40™ supplementation will improve vascular NO function and improve     intermittent claudication in patients with PAD. Using a prospective, double blind, placebo     controlled experimental design in 30 patients, graded treadmill tests will be performed at     baseline and after 3 months after randomization, according to the Skinner-Gardner protocol.     Initial claudication distance (ICD) and absolute claudication distance (ACD) will be     recorded. Two consecutive treadmill tests will be performed within 1 week at baseline (before     administration of study drug); and 2 test will be performed at 3 months. Functional status     will also be assessed by the Walking Impairment Questionnaire and the Health Status Survey     SF-36 questionnaire (SF-36). Vascular function will be assessed with the use of a Vendys®     vascular reactivity (endothelial function) test (Endothelix Inc). Digital pulse amplitude     will be assessed using sensor probes on the index finger during reactive hyperemia. Blood     will be collected for measurement (by Neogenis) of plasma levels of nitrite and nitrate at     baseline and at the completion of the study. Based on previously published trials using this     NO technology, the investigators predict that the group receiving the active supplement will     exhibit an improvement in claudication distance and all measures of vascular function after 3     months.   "
26838|NCT02934425|"     The goal of this study is to assess the effects of consumption of a lean pork-containing,     high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and     cardiometabolic parameters in overweight or obese adults with pre-diabetes.   "
27151|NCT02930551|"     Neuromas are frequent after trauma and surgery, including amputation and can be identified by     high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is     uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be     relieved by injection of local anesthetics near painful neuromas in subjects with peripheral     nerve injury.   "
26840|NCT02934399|"     The study will investigate 27 hour profiles of hormones in the subcutaneous tissue of healthy     subjects and patients with Addison's, Congenital Adrenal Hyperplasia, Growth Hormone     Deficiency, acromegaly, Cushings and Primary Hyperaldosteronism during conventional     diagnostic and therapeutic follow-up.      The 27 hour monitoring by ULTRADIAN takes into account the rhythm of hormones throughout the     day. It is hoped that this information may in the future improve and simplify diagnostic     procedures. Follow-up of patients in endocrinology still remains difficult including clinical     signs of over and under-treatment, questionnaires of quality of life and blood testing     necessitating often retesting. Simplification of the diagnostic procedure by obtaining     detailed knowledge about the rhythm of hormones may contribute to the improvement and     individualization of treatment and may decrease morbidity and mortality of endocrine     patients.   "
26841|NCT02934386|"     The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to     the existing CE-marked WinPack device, compared to two reference devices (one oscillometric     and one volume-clamp device), in healthy subjects and patients undergoing a standardized     physical-activity hypertensive protocol.   "
26842|NCT02934373|"     Clinical study designed to collect user feedback from Cochlear Implant recipients on a new     Sound Processor System   "
26843|NCT02934360|"     The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument     intended for the measurement of high molecular weight human DNA from plasma as an aid to     monitoring disease progression or response to therapy or recurrent or residual disease.   "
26844|NCT02934347|"     Our hypothesis is that the view of the glottis may be improved by putting all patients     requiring intubation in the ramped or back up position while maintaining the classic sniffing     position.   "
26845|NCT02934334|"     The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective,     longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results     may help refine clinical approach to relapse management, and may ultimately help MDD patients     sustain wellness while on antidepressant medication.   "
26846|NCT02934321|"     Erythritol is a low calorie sugar substitute that is being increasingly used to sweeten     beverages and other food items. Greater amounts of erythritol are required to reach the     sweetness level of a common soft drink as compared to aspartame, resulting in higher     osmolarity for the erythritol sweetened beverage. Since associations have been noted between     osmolarity and satiety, investigators propose that an erythritol sweetened beverage may     enhance satiety more than a beverage sweetened with aspartame.   "
26847|NCT02934308|"     Pain in hospitalized patients has received increasing attention, however due to its     subjective nature, it has defied objective, quantitative measurements. If a patient is able     to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS)     or plain numeric scales.When a patient is unable to communicate, a method that would allow     the caregiver to continuously monitor patients' pain and alert the provider that the patient     may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of     analyzing changes in skin conductance that can be used in patients who are unable to provide     a subjective pain score. This study will compare the relationship between the measurements     taken by the PainMonitor and pain scores given by communicative patients to evaluate the     safety and efficacy of this monitor during planned, routine procedures.   "
26848|NCT02934295|"     The aim of the research is to study humoral and cellular immunity in pregnant women for who     the level of rubella virus antibodies is weakly positive, equivocal or negative with the     usual laboratory technique.   "
26849|NCT02934282|"     The purpose of this protocol is to provide treatment with HBOC-201 to patients with     life-threatening anemia for whom blood is not an option. Such patients may also be referred     to in this document as patients who refuse blood transfusion (PWRBT). Other patients who     potentially may require HBOC-201 treatment include those with red blood cell alloantibodies     for whom immunologically compatible red blood cell units cannot be found, although these     patients are less common than PWRBT.   "
26850|NCT02934269|"     This is a randomized, double-blind, placebo-controlled study to evaluate the safety,     tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following     administration of single subcutaneous doses in healthy subjects.   "
26851|NCT02934256|"     1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2;     2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib;     3)Provide an objective basis for an enlarged randomized double-blind trial.   "
26852|NCT02934243|"     Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of     complications there may be situations where it is difficult to insert.      Therefore it seems appropriate to carry out a prospective observational study that will     identify the risk factors relating to the positioning of LM for the purpose of identification     and prediction of them.      From reading the literature and from the opinion of the experts with extensive practice in     airway management (part of the Working Group Management of Airway of the Italian Society of     Anaesthesia, Analgesia, Resuscitation and Intensive Care) some possible causes of difficulty     in the insertion of laryngeal mask have been identified; these possible causes were listed in     a report that will be distributed to the centers enrolled in the conduction of the study.      1,864 patients will be enrolled in 8 Italian research centers to calculate the relative risk     of each of the factors analyzed in order to identify those that, in view of the LM     positioning, must be modified to reduce the risk of failure and, secondly, to identify the     risk factors whose presence may contraindicate the use of the device and indicate the use of     alternative methods for airway management.   "
26873|NCT02933970|"     To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated     telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment     to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in     most cases will be referral to an offsite location for HCV management. The effectiveness will     be expressed through the primary patient centered and clinical outcome, achievement of viral     eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.   "
27152|NCT02930538|"     The proposed research will determine whether a 6-item screening questionnaire previously     shown to correlate with moderate or severe OSA is useful for predicting postoperative     outcomes in children undergoing surgery under general anesthesia.   "
26853|NCT02934230|"     The rapid aging of the population means that anesthesiologists care for elderly patients with     increasing regularity. Although age is an independent predictor or adverse postoperative     outcomes, significant outcome variation exists among older surgical patients. Frailty, a     syndrome that describes an aggregate susceptibility to adverse health outcomes due to age-,     and disease-related deficits that accumulate across multiple domains is a key predictor of     adverse postoperative outcomes in elderly patients. Frail surgical patients are at increased     risk of complications, institutionalization, death, and are high healthcare resource users.      Multiple stakeholders, including anesthesiologists and patients, have identified improving     the outcomes of older patients and preoperative exercise training (prehabilitation) as 2 of     the 10 most important areas for future perioperative research. Physical vulnerability is an     important aspect of the frailty syndrome, and may be amenable to structured exercise therapy.     However, the evidence for preoperative exercise training (prehabilitation) improving     postoperative outcomes is obscured by methodological limitations and a focus on non-elderly     patients. Recently, evidence has emerged that older and sicker patients may benefit most from     prehab, however, this hypothesis has not been formally tested.      Because the complex needs of frail perioperative patients require a longitudinal and     multidisciplinary approach, the investigators are developing a perioperative surgical home     for the frail elderly (PSH-Frail). Development of the PSH-Frail is supported by a robust data     collection system, including linkage of prospectively collected data to health administrative     data infrastructure to improve efficiency and long-term follow up.      The investigators hypothesize that prehabilitation will be a vital intervention supported by     the PSH frail, however, high quality evidence from randomized trials is needed to support its     efficacy. Therefore, the investigators propose a single center randomized controlled trial of     prehabilitation of frail elderly patients having elective abdominal and thoracic cancer     surgery to improve postoperative function (primary outcome), and to decrease postoperative     resource utilization (secondary outcomes).   "
26854|NCT02934217|"     Infarct size is a major determinant of vital prognosis after AMI. We recently reported that     cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly     reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of     cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV     remodelling) at one year after AMI. However, many patients may display increased adverse LV     remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial     aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.   "
26855|NCT02934204|"     Consolidation treatment for Primary Central Nervous System Diffuse Large B cell     Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX     plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.   "
26856|NCT02934191|"     Tonsillectomy is one of the most common pediatric surgical procedures in the United States.     Postoperative pain is substantial, with typical regimens employing narcotic derivatives and     acetaminophen for 1-2 weeks after surgery. Recent enthusiasm for use of ibuprofen as an     alternative has been tempered by equivocal data on its relative safety in regard to risk of     postoperative hemorrhage. The primary objective is to evaluate efficacy of celecoxib for pain     control after tonsillectomy in children. The secondary objective is to assess safety in     regard to postoperative hemorrhage and adverse events.   "
26857|NCT02934178|"     This is a research study about an experimental (investigational) live attenuated Shigella     sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an     immune response. Shigella causes bloody and watery diarrhea, and infants and children living     in developing countries experience the greatest consequences of this disease. The WRSS1     vaccine in will be given to healthy toddlers (12-24 months old). The first vaccination will     be given to toddlers in the inpatient unit and the second and third doses will be     administered on an outpatient basis. A safety evaluation will be preformed after the first     dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose.   "
26858|NCT02934165|"     As the leading cause of death and disability in children in America, unintentional injuries     are a critical public health issue. Most injuries can be prevented by parents implementing     effective child safety practices. This project produced an interactive multimedia (IMM)     program delivered via Internet/Intranet that taught injury prevention skills to parents of     children aged 2 through 5 years, with the ultimate goal of reducing mortality and disability     from unintentional injury in this population.   "
26859|NCT02934152|"     Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of     proton-pump inhibitor has been reported in previous studies. In patients with concurrent     gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of H.     pylori will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor     (PPI) remains elusive Objective: This study aims to investigate the incidence and severity of     acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients     receiving H. pylori eradication Expected result: The investigators will find out the     incidence and severity of acid-related symptoms after discontinuation of proton-pump     inhibitor in reflux patients receiving H. pylori eradication   "
26860|NCT02934139|"     The present study is designed to assess the safety and tolerability of escalating, multiple     ascending doses of Cavosonstat (N91115) in healthy subjects.   "
26861|NCT02934126|"     Background: The Dutch guideline on breast cancer treatment shows several grey areas, where no     clear recommendation is given on the radiotherapy options, but where the advice is to discuss     the treatment of choice with the patient. Currently, patients are exposed to different     information given by the professionals' personal styles of informing patients. The challenge     for all oncological professionals is to give clear, structured, and neutral information on     the pros and cons of the treatment option(s) in the context of the natural course of the     disease to the patient; to elicit patients' needs and preferences. How and which information     should be shared in a decision aid is up for investigation, as well as how this should best     be implemented.      Research goals: Qualitative assessment of patients' and health care professionals'     informational needs and perspectives on breast cancer radiotherapy and shard decision making.      Methods: Semi-structured interviews will be held with both breast cancer patients and health     care professionals. To reach as heterogeneous groups as possible patients of different ages,     with different education levels and who underwent different treatments or chose not to get     radiotherapy at all will be selected . Data will be collected til saturation is reached.     Interviews will be transcribed verbatim and analysed using thematic analysis.      Results: Results of the qualitative study are expected at the beginning of 2017.      Hypothesis: Investigating the patients' and health care professionals' perspectives on shared     decision making and informational needs on radiotherapeutic options will help the development     of a personalized decision aid eligible for broad implementation.   "
27207|NCT02929615|"     The purpose of the study is to research the standard and individualized treatment model for     relapse and refractory lymphatic system malignant tumors.   "
26862|NCT02934113|"     The purpose of this study is to test a workplace intervention program targeted at low SES     workers. Working in partnership with BJC HealthCare, we will test an innovative multi-level     intervention that includes an interactive obesity treatment program (iOTA) using SMS text     messaging. The iOTA intervention will be embedded in a newly described Healthy Workplace     Participatory Program, which incorporates employee participation in decision making to     produce changes in the workplace environment that are acceptable, effective, and sustainable.     These nested interventions will be tested a large delayed-start group-randomized trial. This     study will rigorously test readily scalable interventions that can be translated to other     work settings to reduce obesity and diabetes risk among low SES workers, a group at high risk     for these disorders. This pragmatic clinical trial will advance the long-term goal of     enabling employers and employees to reduce obesity and obesity-associated illnesses including     diabetes.   "
26863|NCT02934100|"     This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with     calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment     provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy     associated with kinesiotherapy and sham laser in combination with kinesiotherapy. In each     group kinesiotherapy treatment is the same and consists of an eight-minute massage of     posterior lower leg muscles and plantar aponeurosis stretching.   "
26864|NCT02934087|"     This study will evaluate a randomized comparison of direct versus snare techniques for     cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure.      This information will be used to determine if primary snaring is superior to retrograde     cannulation in decreasing procedural time and radiation exposure.   "
26865|NCT02934074|"     Twenty individuals who were referred to receive physiotherapy will be participants of the     study. Participants with lower limb loss will evaluate with the following assessment tools:     Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be     recorded. Gait parameters (step length, variation of step length) will evaluate with Gait     Trainer Biodex 2, at participant's preferred speed.Phantom sensation and phantom pain will be     asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments   "
26866|NCT02934061|"     Open label, randomized, controlled, multicenter study with two parallel groups of patients   "
26867|NCT02934048|"     Strongly evidence supports that H. pylori eradication is an effective approach to reduce the     incidence of those pathologies. However, due to the increasing resistance rates to     antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy     for persistent H. pylori infection is becoming a grand challenge the investigators have to     face.   "
26868|NCT02934035|"     Major depressive disorder (MDD) affects around 7% of the population yearly. Although     effective treatments are available, only around half of all patients participating in     clinical trials respond to 6 to 12 weeks of antidepressant treatment. Given these high     failure rates, the ability to predict as early as possible whether a patient is (un)likely to     respond would be of great value, as it would enable physicians to change treatment strategies     faster.      Early improvement has consistently been found to be a strong predictor of later response.     However, misclassification is still quite common, with perhaps a third of those who do not     show early improvement going on to respond. Conversely, a substantial proportion of those who     do show early improvement do not go on to respond. One possibility for improving the     predictive power of early improvement is to examine individual symptoms, rather than the     total score on a depression rating scale. Some items, for example, could reflect     antidepressant side effects (e.g. gastrointestinal symptoms) and may not be very predictive.      The proposed project aims to examine the relationship between early improvement in individual     symptoms and response to antidepressants in a very large patient sample. This large sample     size makes it possible to use more rigorous methods than previous studies, such as the use of     cross-validation to confirm the findings. It also makes it possible to examine a large set of     predictors, including possible interactions among early-improving symptoms and between     symptoms and demographic factors like age and gender. The added value of individual symptoms     over and above using the total symptom score alone will also be examined, as well as possible     differences between different antidepressant classes.      The project will use penalized (lasso) regression, which is well-suited to analyzing data     with a large number of (potentially highly correlated) predictors. In the primary analysis,     response after 6 weeks of treatment will be predicted. In secondary analyses, remission at     week 6 and response and remission at week 12 will also be predicted.   "
26869|NCT02934022|"     Many patients on Highly Active Antiretroviral Therapy (HAART) are able to achieve a sustained     response with viral loads becoming undetectable and staying undetectable, but do not have an     increase in their CD4 counts to levels greater than 500. Adding maraviroc to the treatment     regimen of these patients may result in an increase in their CD4 counts. As the patient would     be continuing their prior regimen, they will likely continue with full control of viral     replication.   "
26870|NCT02934009|"     The determination of fluid status in dialysis patients is a major clinical problem. In this     study the NMR-MOUSE is used to determine if it can be used to non-invasively determine     hydration status of the skin. This evaluation will be performed in dialysis patients and     healthy volunteers.   "
26871|NCT02933996|"     Cardiac surgery usually leads to postoperative immunosuppression, which is characterized by     predisposition to develop secondary nosocomial infections and high risk of tumorigenesis and     development. Current studies showed that acupuncture treatment was effective on     immunoregulation. Our previous study proved that electroacupuncture (EA) can regulate the     innate immune system overreaction to endotoxin and reduce excessive inflammatory response     induced by myocardial ischemia and reperfusion. However, whether transcutaneous electrical     acupoint stimulation(TEAS) can improve immune function in patients post cardiac surgery is     not clear. The investigators perform a randomized controlled study to evaluate whether TEAS     treatment can improve the immunosuppression post cardiac surgery, which may provide rational     for the development of TEAS to treat cardiac patients perioperatively.   "
26872|NCT02933983|"     The aim of this study is to investigate whether the microbiota in the upper respiratory tract     (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is disturbed     compared to healthy individuals. Therefore, bacterial DNA from swabs, aspirates and tissue     will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq     sequencing in order to identify the bacterial species present in these samples. Special     attention will go to microbial species that are overrepresented in the healthy populations as     potential health promoting microbes (i.e. probiotics). A better understanding of the URT     microbiome might help us to better understand the pathology of CRS and might help to develop     new microbiota-based strategies for CRS.   "
27269|NCT02928809|"     The objective of this study is to perform an evaluation of the effect of LLLT on the     prevention of fatigue in the masseter and anterior temporal muscles in young individuals with     and without TMD.   "
26874|NCT02933957|"     Traditionally, people have always been focusing on vascular injuries by angiography. Recent     years, the investigators have further known that the pathological foundation of various     cardiovascular complications not only lies in the vascular lumen, but also vessel wall.     Therefore, now it is possible to detect and prevent vascular disease early. There are many     influencing factors on functional and structural damages of vessels, including genetic and     environmental factors. The investigators have done many researches on populations of the Han     nationality, which has the largest population in China. Thus, the investigators further     wonder whether the function and structure of vessel differ in the She Minority of a remote     southern region in China. The investigators will enroll 150 subjects of two ethnic groups     respectively in the local population， namely She Minority and Han nationality. All subjects     enrolled into the study will complete a questionnaire survey of the general situation and     conduct vascular related examinations, including evaluation of arterial stiffness, arterial     elasticity indexes, subclinical carotid atherosclerosis and biomarkers. The investigators     will analysis vascular differences between the two populations and provide a theoretical     basis for the specific strategies of prevention and treatment.   "
26875|NCT02933944|"     The purpose of this study is to determine safety and anti-tumor immune activation generated     by TG02 and Granulocyte macrophage colony stimulating factor (GM-CSF), first as monotherapy     (Part I), thereafter in combination with the checkpoint inhibitor pembrolizumab (Part II), in     patients with locally recurrent rectal cancer scheduled to have surgery.      Part I and Part II will include approximately 10 patients each. Part I and Part II are     separate and independent sequential components of the study. Patients will only be able to     participate in either the Part I cohort or Part II cohort.      Main objective of the study is to investigate safety and immune response after     TG02-treatment.   "
26876|NCT02933931|"     This prospective observational cohort study will follow the roughly 100 adults who received     the VSV-ZEBOV vaccine in the Geneva phase 1 randomized controlled trial in 2014-2015 in order     to determine their long-term (5-year) immune response to vaccination.   "
26877|NCT02933918|"     Chronic rhinosinusitis (CRS) is one of the most common chronic diseases, affecting the     quality of life of patients who suffer. Despite medical and surgical treatments available,     there are a significant number of people suffering from CRS refractory to these standard     treatments.      A preliminary clinical trial conducted at CHUM Hôtel-Dieu, has allowed us to evaluate the     therapeutic potential of intranasal irrigation of probiotics in patients with CRS. This     treatment administered twice daily for 14 days was well tolerated and resulted in improved     chronic rhinosinusitis symptoms.      Prior to deployment on a larger scale, the safety of this therapy must be confirmed in a     healthy population, free of sinus disease. Therefore, this study aims to assess the safety of     the use of probiotic intranasal irrigation in healthy volunteers.   "
26878|NCT02933905|"     Influence of the vitreomacular interface on the progression of diabetic macular edema after     treatment with intravitreal injection of vascular endothelial growth factor inhibitors   "
26879|NCT02933892|"     The investigators will conduct a randomized controlled trial that aims to compare the     incidence of contrast-induced nephropathy between transradial- and transfemoral-access     cardiac catheterization.   "
26880|NCT02933879|"     A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical     Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical     product in Patients with Mild to Moderate Onychomycosis   "
26881|NCT02933866|"     A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III     Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with     Mild to Severe Scalp Psoriasis   "
26882|NCT02933853|"     A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting     Insulin Aspart in Subjects with Type 2 Diabetes Mellitus   "
26883|NCT02933840|"     The purpose of this study is to determine the efficacy of a remote patient monitoring     platform and alert system in reducing adverse events for hospitalized geriatric orthopedic     trauma patients.   "
26884|NCT02933827|"     1. To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate          to Severe Chronic Kidney Disease        2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with          Moderate to Severe Chronic Kidney Disease   "
26885|NCT02933814|"     This study is being done to evaluate pain management regimens following ambulatory hand     surgery. Improved pain control may be associated with decreased complications, decreased pain     scores, decreased opioid dependence, improved patient comfort and satisfaction, and reduced     healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There will be     two groups. One group will receive liposomal bupivacaine. One group will not. The results     will be compared.      Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will     participate in this study at LLU.   "
26886|NCT02933801|"     The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on     radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel     hormonal agents who have non-progressive disease after chemotherapy with a taxane.   "
26887|NCT02933788|"     This study evaluates the more suitable treatment for the prevention of vascular complications     in diabetes patents who were at high cardiovascular risk group by comparing the platelet     aggregation inhibitory effect of aspirin and cilostazol.   "
26888|NCT02933775|"     This study is designed for determining the safety and relative engraftment levels of the     redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients     with CD19-positive B cell leukemia and malignant lymphoma.   "
26889|NCT02933762|"     The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose     response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and     cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro)     inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by     single and multiple dose administration.   "
27270|NCT02928796|"     Uncovering the distinct measurements and features that potentially exist in different levels     of expertise when performing cardiology-based procedures. There is a belief that tracking the     visual attention and other psychophysiological measures during performance of these     procedures may assist in uncovering the attentional capacity of participants and how it links     with overall performance.   "
26890|NCT02933749|"     The sitting or prone positions are used for posterior fossa surgery. Although the sitting     position may cause hemodynamic instability, venous air embolism, it also provides optimum     access to midline lesions, decreases intracranial pressure. The sitting position has not been     only used in neurosurgery, it has been also used in the shoulder surgery. The sitting     position related hypotension may reduce the cerebral perfusion pressure, therefore may cause     cerebral ischemia. The sitting position related cerebral ischemia has been shown in the     shoulder surgery. The non invasive cerebral oxymetry (INVOS-Covidien) has been used to     measure cerebral oxygen saturation. Some studies has been done to investigate whether the     sitting position cause cerebral desaturation or not in the shoulder surgery by non invasive     cerebral oxymetry. The study results are controversial.      It has been investigated that the effect of the prone position on the cerebral oxygenation in     the spine surgery and the investigators found that the prone position may increase cerebral     oxygenation.      However, all studies have been done in patients without intracranial pathology. We speculate     that due to the sitting position reduces the intracranial pressure, it may improve the     cerebral oxygenation in the patients have intracranial pathology. Therefore we will compare     the sitting and the prone positions effects on the cerebral oxygenation in patients     undergoing posterior fossa tumour surgery by non invasive cerebral oxymetry.      Method: 62 patients have posterior fossa tumour will include the study. Patients will divide     to 2 groups according to the surgical position, the prone (n=31) or the sitting (n=31).     Patients heart rate, mean blood pressure (MAP), cerebral oxygen saturation (SctO2),     peripheral oxygen saturation (SpO2), BIS values will record before the induction of     anesthesia. Five minutes after the standard anesthesia induction all values will record and     it will accept as a baseline. After that all these parameters will record in each 3 minutes     until the beginning of surgery. Mean while, more than 5 % reduction in SctO2 and more than 20     % reduction in SctO2 and/or MAP will record. As well as, if the SctO2 reduces than 55 and 60     %, it will record.   "
26891|NCT02933736|"     In the proposed trial, patients will be administered ribociclib prior to surgical resection     of their tumor. Patients will be enrolled in time-intervals sequentially (non-randomized).     All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose     occurring at one of 3 intervals before brain tumor resection.   "
26892|NCT02933723|"     The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell     responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.   "
26893|NCT02933710|"     The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical     settings in accordance with the Ministry of Food and Drug Safety regulation.      Primary objective:        -  To describe the safety profile of the first dose of IMOJEV® administered under routine          health care visit as primary vaccination or as booster.   "
26894|NCT02933697|"     The Study is an open-labeled, randomized controlled trial, phase IIIb. Its objective is to     assess the safety of the factor Xa inhibitor apixaban versus the vitamin-K antagonist (VKA)     phenprocoumon in patients with NVAF and ESKD on hemodialysis. The safety will be assessed by     means of the incidence of major and clinically relevant, non-major bleeding on     anticoagulation.   "
26895|NCT02933684|"     The proposed project aims to increase accessibility of exposure therapy, an evidence based     treatment for social anxiety disorder, by adapting a therapist-assisted computer-based     program to be delivered in a self-guided manner on an iPad. A significant problem with     self-guided treatment delivered via computer is compliance. The vast majority of users do not     complete treatment, so achieving therapeutic benefit as quickly as possible is essential.     D-cycloserine is a drug found to augment response to therapist-guided exposure therapy for     anxiety disorders, but has never been tested with self-guided exposure. This study uses a     randomized, double-blind methodology to compare D-cycloserine (50 mg; DCS) to placebo in     combination with self-guided virtual reality exposure therapy (VRE) delivered via iPad to     treat social anxiety disorder. The proposed study tests the hypothesis that patients who     receive DCS in combination with the self-guided VRE will show more improvement than those who     receive placebo in combination with VRE. Outcome measures include self-reported symptoms of     social anxiety, behavioral avoidance, and diagnostic remission. Participants (N=34) are     adults with a primary diagnosis of social anxiety disorder. Participants will complete a     structured diagnostic interview, standardized self-report measures of social anxiety, and a     behavioral avoidance task (i.e., giving a speech) and will be assessed at pre-treatment, at     post-treatment and at 3 month follow-up. Hierarchical linear regression and chi-square     analyses will be used to test differences between those randomized to DCS versus placebo on     the following outcomes: post-treatment scores of self-reported social phobia symptoms,     willingness to and anxiety while giving a speech at post-treatment, and diagnostic remission     at 3 month follow-up. The proposed project combines technological advances with translational     research to develop an innovative and accessible treatment for those with social anxiety     disorder. The pilot data generated from this study will be appealing to a variety of funding     agencies, including the National Institute of Mental Health's call for exploratory clinical     trials of novel interventions for mental illnesses, the Patient-Centered Outcomes Research     Institute's call for effectiveness studies aimed to overcome barriers to treatment, and the     National Science Foundation's call for innovation-technology translation research.   "
26896|NCT02933671|"     The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection     technique (also called a nerve block) that numbs the nerves going to the side and front of     the upper leg will improve pain control after surgery. The SIFI technique uses a numbing     solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This     block may affect movement in the leg and make the legs weak. The amount of leg weakness is     not known and assessment of this will be included in the study. Many institutions use the     SIFI block for patients having total hip replacements, with the hope of providing good pain     relief combined with improved mobility after surgery.   "
26897|NCT02933658|"     A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing     clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of     Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers   "
26898|NCT02933645|"     Recent research has suggested that intranasally administered insulin can reach the brain     quickly without passing through circulation and evoke increased insulin sensitivity and     tissue glucose consumption during insulin stimulation (low-dose hyperinsulinemic, euglycemic     clamp). It is still not known what mechanism causes these changes or what tissues are     involved in this.      In this study, the changes in tissue-specific insulin sensitivity and glucose uptake will be     investigated by using glucose-analogue radiotracer ([18F]-fluorodeoxyglucose) with positron     emission tomography (PET) imaging during insulin stimulation. Ten healthy males are studied,     each receiving nasal sprays containing insulin or placebo in a randomized order on two     separate days. After spray administration, glucose uptake in skeletal muscle, liver,     subcutaneous and visceral adipose tissue, myocardium, intestines, brown adipose tissue and     brain assessed by PET imaging and glucose uptake in these tissues is analyzed. Endogenous     glucose production is calculated facilitating the measurements glucose and radiotracer uptake     in tissues and tracer loss into urine.      As skeletal muscle consumes most of the glucose available, it is likely that administration     of insulin sprays will result in an increased uptake in this tissue. Some increase in glucose     uptake might also be seen in other tissue types after insulin spray versus placebo spray     administration.   "
26899|NCT02933632|"     Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).   "
26900|NCT02933619|"     Following product approval, confirmation of appropriate VF episode detection after MRI     exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold     changes post-MRI.   "
26975|NCT02932644|"     The aim of the study is to evaluate cardiovascular events during long-term follow-up in     Rheumatoid Arthritis. The primary outcome any cardiovascular event will be evaluated using     systematic audits of patient records, and will be associated to low levels of vitamin D at     baseline, to investigate the hypothesis that low levels of vitamin D can be part of a     prediction model for cardiovascular disease in Rheumatoid Arthritis.   "
26902|NCT02933593|"     The investigators plan to monitor the central blood pressure in women with severely elevated     blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3     different options for blood pressure control, however no one has studied how these     medications affect the central pressures, only peripheral blood pressure.   "
26903|NCT02933580|"     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics     (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of     single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.   "
26904|NCT02933567|"     In response to the growing need for training on interventions to address first episode     psychosis, the Center for Social Innovation (C4) has partnered with experts in Coordinated     Specialty Care (CSC) to develop and test CSC OnDemand: An Innovative Online Learning Platform     for Implementing Coordinated Specialty Care. The product builds on the findings of the     Recovery After an Initial Schizophrenia Episode (RAISE) studies, funded by the National     Institute of Mental Health (NIMH). RAISE examined team-based models of care for people early     in the course of schizophrenia. Through a Fast Track Small Business Innovation Research     (SBIR) grant, investigators will prototype, test, refine, and evaluate the impact of CSC     OnDemand.   "
26905|NCT02933554|"     Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis     (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention     of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and     may need liver transplant.      Recent studies have shown that blocking blood vessels to a particular portion of the stomach     (bariatric or left gastric artery embolization) can temporarily decrease levels of the     appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to     determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads     to clinically significant weight loss with improvement of NASH.   "
26907|NCT02933528|"     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal     Use Treatment with DSXS .   "
26908|NCT02933515|"     The long-term goal of this project is to advance best practices in occupational therapy (OT)     to manage fall risk factors and reduce fall rates in older adults with stroke. To address     this long-term goal, this team previously developed and pilot-tested a therapeutic yoga     intervention to improve balance, balance self-efficacy, and fear of falling and a group OT     intervention to improve the management of fall risk factors and fear of falling. The success     of both prior studies supports Merging Yoga and group OT to improve balance, balance     self-efficacy, and fall risk factor management. The objectives of this feasibility study are     to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change     in balance, balance self-efficacy, and fall risk factor management.   "
26909|NCT02933502|"     An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal     Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to     SevereScalp Psoriasis   "
26910|NCT02933489|"     This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging     (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense     breast. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful     magnet linked to a computer and used to create detailed pictures of the breast in less than     10 minutes. These pictures can show the difference between normal and diseased tissue.     Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each     breast to produce a 3-dimensional rendering of the entire breast. Combined screening with     abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen     women with dense breasts.   "
26911|NCT02933476|"     The purpose of this study is to examine the possibility of a new, non-invasive, non-drug     treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation     delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment,     participants will also undergo kinematic testing.   "
26912|NCT02933463|"     This study is designed to clinically evaluate the retention and development of caries when     using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and     fissure sealant in young first permanent molars.   "
26913|NCT02933450|"     The Investigator hypothesize that a single dose of patiromer will lower serum potassium     levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied     in at least two multicenter randomized controlled trials, the Investigator further     hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic     patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate     for this study because the research staff will enroll patients with moderate (K greater than     6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this     population for more effective control.   "
26914|NCT02933437|"     Standard, high lead and sodium channel provoked electrocardiograms of a healthy volunteers     will be performed to observe the various ECG changes. Participants will the undergo detailed     imaging with cardiac magnetic resonance imaging and deep genotyping to identify structural or     genetic variants which might dictate the electrocardiographic patterns at rest and with     sodium channel provocation.   "
26915|NCT02933424|"     The objective of this study is to compare the effects of adding three plant-based proteins     (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and     subsequent food intake of healthy adults.   "
29011|NCT02905916|"     The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary     prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.   "
26916|NCT02933411|"     This is a research study for patients diagnosed with heavy menstrual bleeding (HMB) and low     Von Willebrand Factor (VWF). Menstruation, also known as a period, is the regular discharge     of blood and tissues from the uterus. HMB is having a heavier amount of discharge during     menstrual period. Low Von Willebrand Factor means that the participant has lower level of a     blood protein that is important for clotting of blood and so, the participant is at a higher     risk for bleeding.      The purpose of this project is to study the genetic differences of adolescent females with     HMB and low VWF activity and compare the genetic differences with their bleeding     manifestations, response to medications and outcome.   "
26918|NCT02933385|"     Currently there are very few efficacy studies that integrate classical interventions     (screening clinics) and online tools in order to obtain sustainable lifestyle changes in     workers. The current project aimed to evaluate l'efficiency of a combined approach versus     more traditional approaches. Health Data collected by CAPSANA in the workplace between 2012     and 2014 showed that, out of 4231 workers, 69% should aimed at a more active lifestyle and     74% at a better nutrition profile. In addition, 53% of the sampled population was overweight.     In this context, the current project aimed to motivate and follow individuals towards a     healthier lifestyle. To do so, the Défi Santé Plus+ will be implemented and tested using     various versions (light to more complete) in several compagnies.   "
26919|NCT02933372|"     Varying oral doses of Varenicline (VCN), starting with very low doses, will be administered     to participants with Parkinson's Disease (PD) for several days. Positron emission tomography     (PET) scans after administration of VCN will be used to determine the lowest oral dose of VCN     producing an adequate brain level of VCN. With an appropriate oral dose of VCN identified,     the investigators will administer VCN to PD participants to determine if VCN improves walking     speed and measures of balance. VCN will receive VCN or a placebo (fake drug) for 3 weeks to     assess the effects of VCN administration on gait speed and balance. Participants will undergo     examinations to assess the intensity of their Parkinsonism and asked questions to assess     their mood and thinking.   "
26920|NCT02933359|"     The primary objectives of this study are:      i) to procure human calvarial bone, ii) to grow cells from these tissues in vitro, iii) and     to evaluate the osteogenic potential of these cells.   "
26921|NCT02933346|"     Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated     under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their     long-term clinical characteristics, notably the treatments they received after nivolumab     discontinuation. The profile of these patients shows greater conformity to that of a     non-selected population, yet the clinical data collection does not reflect real life     conditions and stops when treatment ends, which does not enable us to get an overview of     post-immunotherapy treatments.   "
26922|NCT02933333|"     The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on     prevention and treatment of infection in children with malignant tumor.   "
26923|NCT02933320|"     The purpose of this study is to identify the tolerable dose of BI-1206 for patients with     B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an     anti-CD20 antibody   "
26924|NCT02933307|"     Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For     this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is     used. Although the MEWS provides relevant data on patients' health status, the interval     measurements may not capture early deterioration of vital signs, especially during the night.     As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac     arrhythmias, which are known to complicate postoperative course. Besides, this way of     measuring vital signs may be stressful for patients and disturbs patients' sleep. New     technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of     vital signs using wearable devices transmitting relevant data to nurses and clinicians. With     this, the investigators think that clinical deterioration may be detected in an early phase     and reduce nurse work load and patient distress.      Objective: to investigate the feasibility of wearable devices on the general ward.      Study design: feasibility study.      Study population: adult patients hospitalized on the internal medicine ward and adult     postoperative patients on the surgical ward.      Intervention: patients in the intervention groups will be randomized in one of the two     groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the     HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements     take place at usual time points.      Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome     measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS     measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side     effects of devices, STAI scores, and PCS scores will be documented.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Patients will wear one device for at least three days. Devices can be     uncomfortable by being heavy or the patches can start itching. More measurements by nurses     can take place when indicated, for example after alarms. The participating patients will fill     out the STAI on daily basis and the PCS on the last day of hospitalization. Both     questionnaires will take a few minutes to complete. Patients could benefit from early     detection of clinical deterioration and early corrective interventions or ICU admissions.   "
26925|NCT02933294|"     Lung cancer is one of the most common cancers in the world. At present, surgical resection is     still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung     resection is a routine surgically procedure for early stage lung cancer while uniportal     thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS     pulmonary resection has been proven to be effective in preventing postoperative morbidities,     there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is     equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of     this multicenter randomized controlled trial study is to compare the uniportal VATS with     traditional triportal VATS pulmonary resection in postoperative complications, long-term     survival, lymph node dissection and local recurrence.   "
26926|NCT02933281|"     MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The     active control is BCG (5 x 10^5 CFU). Participants will receive a single dose of MTBVAC or     BCG revaccination administered intradermally on Study Day 0.   "
26927|NCT02933268|"     DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum     water intake in ADPKD.   "
26949|NCT02932982|"     Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign     of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm     and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical     situation, in the absence of objective argument. The sense of reinsurance reflects a sense of     confidence about the patient's situation, in the absence of objective argument. Gut Feelings     plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring     the Gut Feelings was validated in French after a linguistic validation procedure.   "
27030|NCT02931929|"     Tyrosine-kinase Inhibitors (TKI) resistance in gastrointestinal stromal tumours (GIST) is a     common problem after prolonged treatment periods. The main objectives of this monocentric     diagnostic Phase I/IIa study are safety and tolerability, pharmacokinetics and dosimetry of     68Ga-NeoBomb1 in GIST patients. The rationale behind this study is to improve diagnostic     accuracy in GIST via positron-emission tomography/computer tomography (PET-CT) with a focus     on TKI-resistant subtypes. Better detection, classification and definition of lesion extent     are expected from the use of 68Ga-NeoBOMB1.   "
27031|NCT02931916|"     The purpose of this study is to evaluate the reliability and validity of smart-phone based     system in postural control ability assessment on subjects with chronic ankle instability.   "
26928|NCT02933255|"     Background:      The immune system is the cells and organs in the body that recognize and fight infection and     cancer. The PROSTVAC vaccine might teach the immune system to find and kill certain prostate     cancer cells. Nivolumab and ipilimumab are drugs that allow the immune system to fight     tumors. They might help PROSTVAC work better.      Objective:      To test the safety and effectiveness of the combination of PROSTVAC, nivolumab, and     ipilimumab. To test this for people with castrate resistant prostate cancer and then for     other people with prostate cancer.      Eligibility:      Men ages 18 and older with prostate cancer      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Electrocardiogram        -  Bone scan        -  CT scan or MRI        -  Tumor sample. This may be from a previous procedure.      All participants will get a combination of the study drugs over 8 weeks. They will have 1     visit for the initial injection then 3 booster injection visits. Blood will be tested at     these visits.      Over the next 4 weeks, some participants will have:        -  An exam of the large intestine through the rectum.        -  CT and bone scans        -  Standard hormonal treatment        -  Option to continue treatment every 3 weeks if their disease does not get worse. They          will be have scans every 12 weeks.      Other participants will have surgery to remove the prostate in week 9.      Participants will have a safety visit about a month after their last treatment. This will     include a physical exam, blood tests, and possibly scans.      If their cancer progresses, participants will leave the study and may enroll in a long-term     follow-up study. They will be contacted once a year to ask about their cancer and treatment.   "
26929|NCT02933242|"     This is a study measuring toxicity while making observations about the survival benefits of     treating participants with oligometastatic disease using stereotactic ablative radiotherapy     (SABR).   "
26930|NCT02933229|"     Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global     population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By     causing progressive damage to the stomach and may eventually result in gastric atrophy, H.     pylori infection has been demonstrated to be responsible for more than 95% of gastric     malignancies   "
26931|NCT02933216|"     Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine     bleeding in women. No clinical guidelines have been issued for the management of CSD.     Currently, several limited surgical management procedures for CSD have been reported, such as     hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope + laparoscope)     and vaginal repair of CSD (abbreviated as VR). However, which management can achieve better     clinical effects remains unknown. Therefore, this prospective study is designed to compare     the therapeutic effects between VR and hysteroscope + laparoscope in the treatment of CSD.   "
26932|NCT02933203|"     The purpose of this study is to examine whether stress predicts telomere length in     individuals who hold executive-level positions. Telomeres are the caps at the end of each     strand of DNA that may affect how cells age. Subjects will complete an online     survey/interview and provide one blood sample or saliva samples. The goal is to understand     whether stress predicts genetic markers of longevity.   "
26933|NCT02933190|"     To investigate the fertility in patients after treatment by transvaginal surgery or uterine     artery embolization combined with uterine curettage   "
26934|NCT02933177|"     In order to offer a non-drug intervention for caregivers in nursing home to respond promptly     to a behavioral crisis with an appropriate response to each patient, a chariot has been     developed by the Institute of Ageing Well Korian (Institut du Bien Vieillir Korian) to bring     together eleven mediation activities. These activities lasting about 15 minutes are based on     emotion (reminiscent, games) and sensory interventions (music, massage, touch) to     decentralize patient stimulus that disturbs and focus on a subject not disruptive. This     emergency intervention should provide a reduction in Behavioral and Psychological Symptom of     Dementia (BPSD) of nursing home patients. The main objective is to measure its immediate     effect on productive symptoms (agitation, aberrant motor behavior and disinhibition). The     secondary objectives are to measure its immediate impact on the well-being and psychotropic     treatments, and measure its effect after two months and after four months on all BPSD with a     focus on agitation, the administration of psychotropic drugs, the hospitalizations and the     number of falls.   "
26935|NCT02933164|"     The purpose of this clinical investigation is to evaluate the effectiveness of modified     Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose     Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM     System usage, while in the clinic and during home use.   "
26936|NCT02933151|"     To conduct a pragmatic randomized clinical trial in which the researchers will determine the     mortality impact of a protocol whereby all hemodialysis patients receive an oral,     protein-based nutritional supplement during the dialysis procedure as compared to the     existing nutritional protocol whereby only hemodialysis patients with serum albumin below 3.5     g/dL and incident hemodialysis patients during the first months of care receive an oral,     intradialytic protein-based nutritional supplement during the dialysis procedure.   "
26937|NCT02933138|"     Purpose: The mechanism of most of the multifactorial chylomicronemia (MCM) remains elusive.     In order to decipher the mechanisms involved in the occurrence of this disease, plasma TG     lipolysis characteristics will be monitored for 60 minutes after heparin injection instead of     the 10 minutes gold standard, in a large group of genotyped MCM patients.   "
26950|NCT02932969|"     The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and     pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is     no formal hypothesis to be statistically tested.   "
26974|NCT02932657|"     Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care     teams perceive the boundaries of a support mainly focused on drug treatments. The patient had     no other choice but to learn to live with their disease, the goal is to make every effort so     that tames the disease while maintaining high self-esteem that gives meaning to his life,     allowing, among other things, a good grip of treatment.      Through this research we hope to encourage the integration of art therapy in the course of     care of cystic fibrosis patients, from children to adults before and after transplantation,     in connection with the patient education and counseling   "
26938|NCT02933125|"     Background: Substance abuse among children and adolescents is an important public health     issue in Taiwan. Kaoshiung Chang Gung Memorial Hospital and Taiwan Kaoshiung Juvenile and     Family Court will cooperate in a counseling program for adolescents with illicit drug abusers     in 2013, to perform a mandatory 10-week family-based group psychotherapy.      Aims: This study aims (1) to investigate the effectiveness of the family-based group     psychotherapy for adolescents with illicit drug abusers and their parents; (2) to identify     whether the counseling program is effective for preventing the adolescents from relapse of     substance abuse.      Expected Results: The investigators expect that (1) group psychotherapy may involve     comprehensive benefits for adolescents with illicit drug abusers, by improving the changes in     adolescents' substance-craving symptoms and behavioral problems, and reducing stress of their     parents; (2) this counseling program is effective for preventing the adolescents from relapse     of substance abuse; (3) the findings in this study will not only demonstrate empirical     evidence of treatment effectiveness for adolescents with illicit drug abuse, but will also     provide useful clues for future implementation of policy making.   "
26939|NCT02933112|"     The purpose of the study is to test the workflow of an auto-titrating mandibular positioner     in its intended setting. Participants with obstructive sleep apnea will use the device to     determine their eligibility for oral appliance therapy and provide feedback on usability of     the device.   "
26940|NCT02933099|"     To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA)     with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal     carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.   "
26941|NCT02933086|"     The relevance of this study is given by the feasibility to assess the effect of an     intervention program based on the functionality and trunk neuromuscular activity and postural     control in pregnant women with low back pain. The main outcomes will be computed by     electromyography measurement so that to assess the trunk neuromuscular activation pattern as     well as by force platform parameters for determining of postural control. Clinical symptoms     such as pain intensity, perception of disability and fear and avoidance will also be     computed. This is the first study to compare two intervention methods using the main     biological outcomes related to trunk segment function.   "
26942|NCT02933073|"     This is a Phase I trial to test the safety and feasibility of OncoImmunome vaccine in stage     III/IV ovarian cancer patients. OncoImmunome is a tumor specific vaccine formulation which is     predicted to elicit tumor-protective immune responses. A total of 15 patients will be     enrolled from the Principal Investigator (PI) clinical practice. These patients will have     just successfully completed standard of care surgical debulking with preservation of fresh     tumor, chemotherapy treatment and be in documented clinical remission prior to receiving the     vaccine. The patients receive 6-monthly doses of the vaccine and are monitored for up to 5     years post vaccination. This is a personalized vaccine, unique to each patient and is the     first in human use.   "
26943|NCT02933060|"     The purpose of this study is to determine whether patients in the emergency department with     migraine headache who are administered an intravenous fluid bolus will report greater     improvement in pain scores than control patients.   "
26944|NCT02933047|"     Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to     hysterectomy. It is a safe procedure with low rates of complications and readmissions.     Increasing evidence indicates that LH may be suitable for an outpatient setting but this may     impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient     care to day case surgery might influence readmission rates and postoperative physical     activity. No data are available on the current length of sick leave in Danish patients after     hysterectomy, and the effects of outpatient surgery on this parameter are difficult to     predict. A randomized controlled trial of LH performed as an outpatient procedure compared     with today's inpatient standard will provide a firm platform for future planning of routine     treatment of patients with need of hysterectomy for benign indications.   "
26945|NCT02933034|"     The purpose of this study is to evaluate the safety and tolerance of a new intravenous     diagnostic agent , SeeMore or EVP 1001-1, in patients with Cardiovascular Disease. The     initial phase of this study, NCT01989195 enrolling a total of 6 patients, has been closed.     This second phase adds 10 patients in a safety cohort and 60 additional patients for a total     of 70 patients.   "
26946|NCT02933021|"     This is a study to investigate the functional consequences of paraprotein production in MGUS     (Monoclonal gammopathy of unknown significance).   "
26947|NCT02933008|"     Traumatic, debilitating anterior cruciate ligament (ACL) injuries occur at a 2 to 10-fold     greater rate in female than male athletes. Consequently, there is a larger population of     females that endure significant pain, functional limitations, and radiographic signs of knee     osteoarthritis (OA) within 12 to 20 years FOLLOWING injury. To reduce the burden of OA, The     National Public Health Agenda for Osteoarthritis recommends expanding and refining     evidence-based prevention of ACL injury. Specialized training that targets modifiable risk     factors shows statistical efficacy in high-risk athletes; however, clinically meaningful     reduction of risk has not been achieved. A critical barrier that limits successful training     outcomes is the requirement of qualified instructors to deliver personalized, intuitive, and     accessible feedback to young athletes. Thus, a key gap in knowledge is how to efficiently     deliver objective, effective feedback during training for injury prevention. The     investigators long-term goal is to reduce ACL injuries and the subsequent sequela in young     female athletes. The overall objective of this proposal is to implement and test innovative     augmented neuromuscular training (aNMT) techniques to enhance sensorimotor learning and     reduce biomechanical risk factors for ACL injury. The rationale that underlies this proposal     is that, after completion, the investigators will be equipped to more effectively deliver     biofeedback and decelerate the trend of increasing ACL injury rates in female athletes. This     contribution will be significant for the reduction of the long-term sequel following ACL     injury in young females.   "
26948|NCT02932995|"     The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR     stent), which slowly releases both cilostazol and paclitaxel, for strut coverage,     malapposition, and thrombus formation, assessed by an optical coherence tomography.   "
34419|NCT02835274|"     The primary objective is to characterize the programming effects of Boston Scientific     Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of     Parkinson's disease in acute and chronic settings.   "
26951|NCT02932956|"     This study enrolls patients who have a type of cancer with GPC3-positive solid tumors. The     cancer has come back, has not gone away after standard treatment or the patient cannot     receive standard treatment. This research study uses special immune system cells called GAP T     cells, a new experimental treatment.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting cancer:     antibodies and T cells. Antibodies are types of proteins that protect the body from     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special     infection-fighting blood cells that can kill other cells, including cells infected with     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with     cancers. They have shown promise, but have not been strong enough to cure most patients.      Investigators have found from previous research that they can put a new gene into T cells     that will make them recognize cancer cells and kill them. In preclinical studies, the     investigators made several genes called a chimeric antigen receptor (CAR), from an antibody     called GC33 that recognizes glypican-3, a proteoglycan found on solid tumors (GPC3-CAR). This     study will test T cells genetically engineered with a GPC3-CAR (GAP T cells) in patients with     GPC3-positive solid tumors.      The GAP T cells are an investigational product not approved by the Food and Drug     Administration.      The purpose of this study is to find the biggest dose of GAP T cells that is safe, to see how     long they last in the body, to learn what the side effects are and to see if the GAP T cells     will help people with GPC3-positive solid tumors.   "
26952|NCT02932943|"     This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared     to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive     disorder (MDD) who have a partial response to ADT.   "
26953|NCT02932930|"     The original concept of a quadratus lumborum block (QLB) indicated for analgesia after     abdominal surgery was first described by Blanco in 2007. Also referred to as a posterior     transversus abdominis plane (TAP) block, the QLB consists in deposition of local anesthetic     on either the posterior or the anterolateral border of the quadratus lumborum muscle. TAP     blocks have already been proved effective in urologic, abdominal, and gynecologic procedures     by blocking the sensory nerve supply to the anterior abdominal wall thus reducing the amount     of postoperative analgesic medication. The main advantages of QLB compared to the TAP block     is a wider sensory block area and a longer duration of analgesia. This is due to the     extension of local anesthetic agents beyond the TAP plane to the thoracic paravertebral     space(4).      Previous reports have shown that QLB is effective in providing pain relief after various     abdominal operations. However, there are no published reports on QLB for postoperative pain     after abdominoplasty. This prospective, randomized, double-blinded, controlled study aims to     evaluate the analgesic efficacy, opioids consumption and quality of recovery of QLB in     patients undergoing abdominoplasty. Patients scheduled to have abdominoplasty will be     randomized to receive bilateral QLB with either ropivacaine 0.2% or normal saline.     Post-operative cumulative analgesic medication consumption, pain severity at rest and on     movement, as well as quality of recovery will be evaluated and compared in both groups.   "
26954|NCT02932917|"     Place-based cues can be an important trigger of smoking behavior, therefore the investigators     wish to learn more about the influence of the built environment on individual smoking     behavior. This is to facilitate dynamic support during the post-quit phase. MapMySmoke is a     mobile phone application that enables the capture of spatial data during smoking and craving     events. These data will be used to create individualized support plans via the app.   "
26955|NCT02932904|"     The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once     daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants     after 5 weeks of double-blind treatment.   "
26956|NCT02932891|"     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following     Treatment with DSXS in Patients with Atopic Dermatitis   "
26957|NCT02932878|"     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following     Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis   "
26958|NCT02932865|"     Men are recruited to collect seminal plasma samples and serum samples from men with     azoospermia, men receiving medical treatment of infertility and men attending semen analysis.     MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the groups to find     potential differences. Steroid hormones are analyzed by liquid chromatography-tandem mass     spectrometry.   "
26959|NCT02932852|"     Transplantation of cellularized human cornea impregnated and populated by mesenchymal stem     cells derived from the patient's adipose tissue. The purpose of the study is to assess the     safety, tolerability, and preliminary efficacy of transplantation of a single dose of     autologous mesenchymal adipose tissue derived adult stem cells (ADAS) cellularized into     laminas for subjects with corneal defects. 3 groups will be included in the study: (1)     transplantation of ADAS alone without scaffold, (2) transplantation of scaffold (human     corneal decellularized lamina) without ADAS, and (3) transplantation of ADAS cellularized on     scaffold (the human corneal decellularized lamina)   "
26960|NCT02932839|"     This study aims to uncover the neuronal bases of epilepsy by recording the activity of single     neurons in the brain of patients with epilepsy who are candidates for assessment with     intracranial electroencephalography (EEG). A micro-electrode array will be inserted into the     brain in addition to the standard intracranial EEG electrodes for up to 4 weeks.   "
26961|NCT02932826|"     The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo     expanded umbilical cord blood regulatory T cells on autoimmune diabetes.   "
26962|NCT02932813|"     The aim of this study is to examine the effects of a translational health in nutrition and     kinesiology (THINK) after school program on physical variables, nutrition and exercise     knowledge base/behaviors, and exercise enjoyment and confidence.      Partnering with the YMCA investigators in the Kinesiology and Sport Sciences department at     the University of Miami will set up the after-school THINK program offered three afternoons     per week for nine months in two experimental and two control schools. The schools will     consist of minority elementary school students (predominantly Hispanic and Black) in the     South Florida area. The control schools will receive baseline, mid-year and follow-up testing     nine months later, but will not go through the THINK program. They will instead go through     their standard YMCA after school Sports, Play, and Active Recreation for Kids (SPARK)     program.   "
26963|NCT02932800|"     Context: The central venous catheter is used in intensive care units for several indications,     including the administration of drugs with sclerosis potential, infusion solutions and     hemodynamic monitoring. It can be accessed by per cutaneous puncture using the Seldinger     technique, which is an extremely common procedure in intensive care units. The displacement     or accidental removal of central venous catheter caused by poor fixation have received little     attention, but imply potentially life threatening caused by the complications which can     result from the removal of the catheter and the need for reinsertion. Among these     complications, can mention the interruption of vital therapies (inotropic and vasopressor     drugs) and hemorrhagic shock. In fixing the catheter, the literature is not sufficient to     assess whether sutures, staples or tapes are associated with a higher risk of infections.     Objective: To compare the efficiency in fixing the short stay central venous catheter using     the Ballerina technique associated with flap fixation to the usual fixation technique and     to observe differences in colonization of microorganisms on the device insertion site.     Methods: The investigators propose an individual study, analytical, intervention,     longitudinal, prospective, controlled clinical trial and randomized to be developed in the     Intensive Care Unit Adult Clinical and Surgical of The Samuel Libânio Clinical Hospital in     The University of Sapucaí Valley and Intensive Care Unit Adult Clinical and Surgical of The     Hospital e Maternity Santa Paula. After admission of the patient in the Intensive Care Unit     and obtaining informed consent and informed, with indication of the short stay central venous     catheter, the patient will be allocated through a table of random numbers for the groups:     Habitual Fixation (n = 31) and Fixation with ballerina technique and flip (n = 31). The     participants will evaluate fixation efficiency and colonization of the device's insertion     site.   "
26964|NCT02932787|"     The purpose of this study was to look at the effects that height-adjustable workstations on     occupational sitting time and workplace productivity in office workers. Participants     workplace activity (sitting, standing and walking) and productivity was measured before the     installation of the height-adjustable workstations. Workplace activity and productivity were     then measured four weeks after the installation of height-adjustable workstations and four     weeks after the removal of height-adjustable workstations, where possible. The results were     compared to a control group who received no intervention whilst the intervention had the     height-adjustable workstations.   "
26965|NCT02932774|"     The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl     syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11     years old.   "
26966|NCT02932761|"     Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine     bleeding in women. No clinical guidelines have been issued for the management of CSD. The     investigators have previously demonstrated that vaginal repair of CSD was an relative     effective treatment of CSD. However, only 28.2% of the CSD patients normalized to less than 7     days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months     post vaginal repair. Postoperative menstruation may contribute to surgical site infections,     which may subsequently affect the healing of uterine scars. Treatment CSD patients with     gonadotropin-releasing hormone agonist (GnRHa) may has the potential to improve therapeutic     effects of vaginal repair. Therefore, the current multiple-center randomized controlled trial     was designed to evaluate whether the application of GnRHa in combination with vaginal repair     could achieve better clinical effects than those achieved by vaginal CSD repair alone.   "
26967|NCT02932748|"     The goal of this study is to evaluate the effect of three weight management interventions     (group phone conference calls, individual phone calls, and enhanced usual care) on weight     across 18 months in overweight and obese adults recruited through and treated by rural     primary care clinics.   "
26968|NCT02932735|"     Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer.     Precisely surveillance of patients with GIM may result in early detection and improved     prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all     patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8%     in those patients.   "
26969|NCT02932722|"     This study involves research using human subjects (cardiac surgical patients) to evaluate the     effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied     to upper or lower extremities has been shown cardioprotective role by lowering release of     cardiac troponin in patients with cardiac diseases. However, it is not clear whether     anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC     in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects     of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.   "
26970|NCT02932709|"     Attempted suicide is a major public health problem, and the efficacies of current postvention     protocols vary. The investigators evaluated the effectiveness of telephone follow-up of     patients referred to an emergency psychiatric unit for attempted suicide on any further     attempt/s over the following year.      In a single-center, controlled study with intent to treat, they evaluated the efficacy of a     protocol of telephone follow-up of patients at 8, 30, and 60 days after they had been treated     for attempted suicide. For comparison, they evaluated as controls patients with similar     social and demographic characteristics referred to their emergency psychiatric unit in the     year prior to the study who did not receive telephone follow-up after their initial     hospitalization. Data were analyzed using logistic regression.   "
26971|NCT02932696|"     The main goal of our project is to study and describe the effect of exercise training on     systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial     infarction.      Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed     by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise     training will be improved compared to baseline values as well as compared to values in a     no-training group. Should this hypothesis prove true, it would help explain the improvements     in functional capacity observed during the post-infarction period and after exercise     training.   "
26972|NCT02932683|"     This study was designed to evaluate if MedNav impacts the ability of novice resuscitators to     perform Neonatal Life Support (NLS) in the simulated environment, and if this ability is     maintained after a 7 week period. Testing the nul hypothesis that there is no difference in     technical skill completion when performing neonatal resuscitation on a mannequin with or     without MedNav, immediately after training or after a period of 7 weeks since the training     episode.   "
26973|NCT02932670|"     The aim of this study is to determine the minimum effective volume of lidocaine in 90% of     patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.   "
27271|NCT02928783|"     Home-based rehabilitation programs have not been widely few been studied and the training     effects are not unclear. This study evaluates the beneﬁcial effects of home-based cardiac     rehabilitation on quality of medical care in patients with chronic heart failure.   "
26976|NCT02932631|"     It is estimated that worldwide, about 15 million people are affected by vascular accident     (CVA) per year, and in Brazil, the stroke is a major cause of death and disability,     generating too much economic and social impact by generating motor sequelae , sensory and     cognitive arising from blockage or rupture of blood vessels. Among the motor sequelae is the     hemiparesis, which affects about 80% of cases with consequent impairment of the quality of     life of individuals. However, physical therapy has shown to facilitate return of the function     of these individuals, while minimizing the sensorimotor deficits for promoting neuronal     plasticity through the motor relearning. Among the features of physical therapy are the     conventional physical therapy techniques, Therapy and Restriction of Movement Induction     (TRIM) and the Mental Practice. In view of this, the objective of the study is to compare the     application of conventional physiotherapy protocols and TRIM and / or mental practice on the     morphometric features, functionality and quality of life of post-stroke hemiparetic subjects     in the chronic phase. 60 volunteers will be selected, of both sexes, aged between 45 and 80     years with a clinical diagnosis of stroke, with hemiparesis in the chronic phase were divided     into four groups (N = 15): control group (CG), TRIM Group (GT), Mental Practice group (GPM)     and group TRIM + Mental Practice (GTPM) to perform specific exercises for each group for     three times a week, totaling 24 sessions. Volunteers will be evaluated in four times through     the Fugl-Meyer Assessment scale (FMA) adapted and Motor Ability Test of the Upper Limb     (THMMS) and to assess the Quality of Life will be used Quality Scale Specific Life Vascular     Accident brainstem (EQVE-AVE) and oxidative stress analysis by collecting blood and     electromyography for muscular activity. After the research data will be tabulated on an Excel     spreadsheet to perform intergroup and intragroup comparisons between the four evaluation     times, which will be used for data analysis the BioEstat® 5.2 program, the choice of tests     for analysis dependent on the statistical distribution types found and the homogeneity of     their variances.   "
26977|NCT02932618|"     The purpose of this study in pediatric participants (<18 years of age) with severe hereditary     von Willebrand disease (VWD) is:        1. To assess the efficacy, safety, and tolerability of recombinant von Willebrand Factor          (rVWF), with or without ADVATE, in the treatment and control of nonsurgical bleeding          events        2. To assess the efficacy and safety of rVWF with ADVATE during elective or emergency          surgery        3. To determine the pharmacokinetic (PK) profile of rVWF   "
26978|NCT02932605|"     The main objective of this study is to compare microglia activation as measured with PET in     combination with the tracer [11C]-R-PK11195 between recent-onset schizophrenia patients who     are randomised to CBD and those randomised to placebo.   "
26979|NCT02932592|"     To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients     (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)   "
26980|NCT02932579|"     Opioid analgesics are the most common postoperative pain medications used among dentists in     the United States.Although these medications are highly effective in the postoperative dental     pain management, not all patients optimally benefit from this therapy. Many suffer adverse     consequences such as nausea, emesis, and psychomotor impairment, and there is a high     prevalence of opioid prescription misuse among substance abusers within the dental patient     population.      The use of non-opioid analgesics including ibuprofen and acetaminophen in the management of     postoperative dental pain has demonstrated equivalent or superior analgesic effects compared     to opioid analgesic therapies, typically with significantly less adverse effects.However,     despite these results, dentists have encountered a high variability in the success of     non-opioid analgesic responses among the postoperative dental pain population.Thus, new     strategies for earlier recognition of analgesic responses for pain medications is fundamental     in the field of dentistry. Therefore, this study will evaluate the clinical utility of     pharmacogenomic testing in acute postoperative dental pain management among healthy adults     who undergo extraction of impacted mandibular third molar.   "
26981|NCT02932566|"     This randomised, double-blind, placebo-controlled, phase 2 study aims to evaluate the     efficacy and safety of the anti-fibrotic drug pirfenidone in the treatment of patients with     heart failure and preserved left ventricular ejection fraction (HFpEF). Participants will be     randomised to receive either pirfenidone or placebo, for a period of 12 months.   "
26982|NCT02932553|"     The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold)     implantation with optimal medical therapy can improve the outcome of patients with variant     angina and moderate coronary artery disease.   "
26983|NCT02932540|"     Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally     maintained at a constant level, over a relatively wide blood pressure range. It can be     assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound     probes over both sides of the head to measure changes in blood flow in one of the main brain     arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure     dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following     moderate to severe stroke, acting as a key role in the development of secondary brain damage     related to brain swelling and further damage related to the low blood flow. The     administration of clot busting therapy (thrombolysis), one of the main approved treatments of     acute ischaemic stroke (AIS), results in recanalisation of the blocked artery in only     approximately 50% of patients. Therefore, as well as attempts to treat major vessel blockage,     improving brain blood flow, particularly to the penumbral area, through arteries that bypass     the blockage is another potential therapeutic approach in AIS.One simple way of achieving     this might be to lower the head of AIS patient into a lying flat (0⁰) position. However, to     date, there have been very few studies exploring this. This research will use the noninvasive     technique of Trans Cranial Doppler (TCD) to see how blood flow changes in different head     positions, both in healthy volunteers and AIS patient. This study will provide important data     regarding blood pressure management in acute stroke, an important and common clinical     dilemma.   "
26996|NCT02932371|"     The objective of the study is to estimate the reliability of the determination of the cardiac     output measured by the ECOM™ device. This study will be performed with the latest version of     the software which should give better results than those published previously. Two techniques     of measure of the cardiac output will be compared: the reference measure by trans-esophageal     echography and the bioimpedance used by the ECOM™. monitor.   "
27009|NCT02932202|"     Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal     complications including gestational diabetes, large for gestational age infants, birth     trauma, and stillbirth. The standard of care places the responsibility on the providers     during prenatal visits to remind patients of their weight gain goals and provide appropriate     counseling. The objective of this study is to evaluate a sustainable medical student-assisted     longitudinal program of nutritional counseling and web based nutrition tracking for pregnant     women on excessive weight gain during pregnancy and the effects on diet choices and fetal and     maternal complications.   "
26984|NCT02932527|"     Lifestyle and environmental factors can disrupt development and testicular function. In     France, cannabis is the most widely used illicit substance and about 8% of adults between 18     and 64 years smoke cannabis at least once a year, and mostly men under 45 years.     Endocannabinoids are lipid mediators that share some effects with the active ingredients of     cannabis. Cannabis and endocannabinoids act via two types of endogenous receptors which were     detected at different levels of the reproductive system and are involved in the central and     local regulation of the gonad. Cannabis use may alter the normal regulation of the     endocannabinoid system. In males, the regulation of the endocannabinoid system is critical     for Sertoli and Leydig cells functions, germ cell differentiation, maturation of sperm     nucleus and sperm quality. The cannabis can have a negative impact on sperm parameters,     capacitation and acrosome reaction. Cannabinoids may decrease testosterone synthesis and     induce apoptosis of Sertoli cells. Studies on the effect of cannabinoids on male fertility     are scarce or nonexistent in infertile men because of ethical considerations and bias due to     consumption often underreported. Investigators hypothesized that cannabis use may alter sperm     nuclear quality. Investigators want to explore this hypothesis conducting a multicentric     prospective study exposed/non-exposed in infertile men who are consulting for Medically     Assisted Reproductive Technologies (ART). To reach this study, it is planned to include a     total of 200 subjects taking into account any exclusions.   "
26985|NCT02932514|"     The purpose of this clinical investigation is to evaluate the accuracy of the Eversense     Continuous Glucose Monitoring System (Eversense System) measurements when compared with a     Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance     in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System     usage, and assess the usability of the Eversense system in the hands of user at home setting.     Changes in HbA1c from baseline will also be evaluated.   "
26986|NCT02932501|"     Approximately 500 patients will be included in this patient registry. Data collection     includes demographics, clinical data of underlying disease and use of bisphosphonates,     denosumab and antiangiogenic drugs , degree and extension of osteonecrosis,     osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.   "
26987|NCT02932488|"     The purpose of this study is to show that PET-MR imaging can be used for obtaining a     pharmacodynamic profile of drugs. By using the 5-HT1B receptor as target we also aim to find     effect areas and sizes of the 5-HT1B receptor agonist sumatriptan.   "
26988|NCT02932475|"     Purpose: The objective of this proposal is to study the safety and efficacy of metformin     added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.      Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.     clinical centers      Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a     singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary     outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth     trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical     visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.   "
26989|NCT02932462|"     A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III     Clinical Study   "
26990|NCT02932449|"     This is a 5-year, longitudinal, observational study of patients with PBC designed to     specifically address important clinical questions that remain incompletely answered from     registration trials. In addition to the study database, a bio specimen repository will also     be included so that translational studies of genomics and biomarkers of response may be     performed.   "
26991|NCT02932436|"     The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in     addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function     in patients with type 2 Diabetes mellitus.   "
26992|NCT02932423|"     The purpose of this clinical study is to investigate the effect of drinking a sugar-sweetened     beverage along with a meal on insulin concentrations and, glucose and lipid metabolism, in     overweight and obese subjects, during a 10-hour visit.   "
26994|NCT02932397|"     Emergence of general anesthesia is a critical period, in the same way as the induction of     anesthesia, during which several adverse events may occur. Extubation may even be more     difficult than the intubation, with a higher respiratory complications rate. Among these,     cough is common and expected. It can be associated with significant complications including     hypertension, tachycardia, increased intracranial pressure, bleeding at the surgical site or     even wound dehiscence.      The incidence of coughing during emergence of general anesthesia varies depending on the type     of airway instrumentation, the population under study, agents used for the maintenance of the     anesthesia and techniques used to prevent coughing. In the literature, the incidence of     coughing during emergence of general anesthesia under endotracheal intubation varies from 38     to 96%. In our center, the incidence of coughing during emergence of general anesthesia under     desflurane and endotracheal intubation is 30 % according to a local preliminary study.      Propofol is well-known to inhibit airway reflexes. Total intravenous anesthesia (TIVA) is     associated with a lower incidence of coughing compared to inhalated anesthesia. The efficacy     of propofol at a subhypnotic dose to reduce coughing during emergence has recently been     demonstrated in patients undergoing nasal surgery under sevoflurane. However, the most     effective antitussive dose remains unknown and its efficacy during anesthesia under     desflurane has not yet been demonstrated.      Propofol is rapidly available, simple to administer and has an interesting pharmacological     profile, among others due to its short half-life.      The aim of this study is to evaluate if an intravenous bolus of 0.5 mg/kg of propofol is more     effective than placebo administration to decrease the incidence of coughing during emergence     of general anesthesia under desflurane (PROPOREV). Propofol could also reduce the incidence     of postoperative nausea and vomiting (PONV).   "
26995|NCT02932384|"     The proposed research study will focus on Black men who have sex with men (BMSM) who        -  are HIV- or unknown status AND        -  have not received HIV testing in over a year or        -  who test irregularly (on 9/21/2016, the protocol was changed to modify the last to          criteria and focus on those who have not used PrEP in the prior six months).      and implement an innovative, culturally-informed, peer-based, and client-centered approach     that is designed to increase their awareness of their HIV status and their timely entry into     prevention (including PrEP), testing, care, and treatment services. The research design     compares the effect of an incentives-only approach to one that uses incentives, along with     the involvement of peer mentors to support timely entry into prevention, testing, care and     treatment. This phase of the study is designed to assess peer-supported intervention group     versus a passport/incentive-only control group over an 18-month period using a randomized     trial approach.   "
27032|NCT02931903|"     The aim of this study is to assess the effect of the newly introduced (hybrid dental ceramic)     superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient     satisfaction and crestal bone loss.   "
26997|NCT02932358|"     A cluster-randomized crossover trial involving adult ICU patients, family members and ICU     workers is being conducted. Near 35 intensive care units (ICUs) will be evaluated. In the     first study period (T1) Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned     to either an restrictive family visitation model (RFVM) (intermittent visits according to     local ICU regulation) or to a flexible family visitation model (FFVM) (12 consecutive hours     per day) in a 1:1 ratio. After enrollment of 25 patients and 25 family members, there will be     a 30-day period without subject recruitment (T2) to avoid contamination bias. After this     period, each ICU will be assigned to an intervention contrary to that which initially receive     (T3) until the enrollment of more 25 patients and 25 family members. The primary outcome is     the cumulative incidence of delirium among ICU patients. Secondary outcome measures include     delirium-free days, mechanical ventilation-free days, any ICU-acquired infections, ICU length     of stay and all-cause hospital mortality among patients; satisfaction and symptoms of anxiety     and depression among family members; and prevalence of symptoms of burnout syndrome among ICU     workers. Tertiary outcomes include need of antipsychotic use, need of mechanical restraints,     unplanned loss of invasive devices, and ICU acquired pneumonia, urinary tract infection and     bloodstream infection among ICU patients; perception of involvement in patient care among     family members of ICU patients; and satisfaction among ICU workers.   "
26998|NCT02932345|"     The primary objective is to describe the genomic profile of long-term survivors, especially     to find out potential genomic prognosis and/or predictive factors for gefitinib long-term     efficacy as compared to rapid PD patients   "
26999|NCT02932332|"     The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen,     high-flow air, and low-flow air in helping to decrease shortness of breath in cancer     patients. Researchers also want to learn if these therapies can help to improve lung function     and quality of life.   "
27000|NCT02932319|"     15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter     induction at home versus expectative in this population   "
27001|NCT02932306|"     Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris   "
27002|NCT02932293|"     There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg)     in this study but the treatment duration may be different depending on patients' response to     the antiviral therapy and whether patients have liver cirrhosis. If patients have no     cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir,     daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If     patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive     sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be     8 weeks.   "
27003|NCT02932280|"     The purpose of this study is to test the safety of neratinib at different dose levels and to     find out what effects, good and bad, it has on the patients and the cancer.   "
27004|NCT02932267|"     This is a multicenter open-label, prospective study in subjects with dark skin from one of     the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with     moderate to severe acne vulgaris on the face.      All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump     Forte) once daily on whole face.      The purpose of this trial is to evaluate subject reported outcomes with the combination of     Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of     moderate to severe acne in dark skin phototypes (IV to VI).   "
27005|NCT02932254|"     The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1     ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by     rocuronium.   "
27006|NCT02932241|"     Alcohol use is considered to be a significant risk factor among those who die by suicide,     especially among those who drink to regulate their emotions. Unfortunately, there is a dearth     of treatment outcome research for suicidal heavy drinkers. Further, treatments that target     this population must be maximally effective, with promise for wide dissemination. The     application of technology has been increasingly utilized as an efficacious and acceptable way     to rapidly disseminate evidence-base treatment. However, these methods are used infrequently     for individuals deemed too high risk for computerized treatment. Along these lines, the goal     of this project is to begin a line of research focused on developing interventions to reduce     heavy drinking and risk for suicide through the use of technology. Dialectical Behavior     Therapy (DBT) skills training is an effective intervention for behaviors associated with     emotion dysregulation including addictive and suicidal behaviors. Further, DBT skills use has     been identified as the active ingredient for treatment effectiveness; thus, a skills training     intervention delivered via the Internet has the capacity to be a potent and efficient method     of treatment delivery. The goal of this research is to establish a proof of concept for     developing and evaluating a potentially efficacious and acceptable intervention for heavy     episodic drinkers who are suicidal. Specifically, this project proposes to conduct a     randomized controlled pilot trial of a computerized DBT skills training intervention for     suicidal individuals who engage in heavy episodic drinking (HED) to regulate emotions. The     project's aims are to conduct a randomized controlled pilot trial of cDBT vs. a Wait-list     control (WL). This pilot trial is not intended to demonstrate that cDBT works better than     other interventions in improving clinical indices, but rather to determine whether further     revisions of the cDBT intervention are needed and will inform the design of a subsequent     full-scale randomized controlled trial.   "
27007|NCT02932228|"     This evaluation will examine the feasibility, implementation, and effectiveness of a quality     improvement intervention—Intensive Management Patient Aligned Care Team (ImPACT)—for     high-risk patients.   "
27008|NCT02932215|"     This is a 10 week, open-label, prospective study, involving 10 volunteer participants with     cannabis use disorder to test the feasibility and safety of using lorcaserin in addition to     the feasibility, likability, and utility of a mobile sensor device in cannabis users. The     study will be entirely outpatient. Upon study entry, participants will begin clinic visits at     the Substance Treatment and Research Service (STARS) clinic. All consented participants will     receive a Fitbit Charge HR device in week 1 to wear for the entire study and receive     lorcaserin beginning in week 2 for a total of 8 weeks (weeks 2-9). At the beginning of week     10 following discontinuation of lorcaserin, the participants will continue to wear the Fitbit     Charge HR device for this final week following completion of the medication trial. All     participants will visit the clinic twice weekly to provide urine toxicology on THC, report on     adverse events, complete additional assessments (outlined below), and upload de-identified     data from the Fitbit Charge HR device to the secure encrypted Fitabase database. Study     assessments will be collected at baseline, throughout the study, and 1 week following     medication discontinuation. All participants will also receive medical management, a     medication adherence focused psychosocial intervention that facilitates compliance with study     medication and other study procedures, including adherence to wearing the Fitbit Charge HR     device, and promotes abstinence from cannabis and other substances. Progressive voucher     incentives will be provided for compliance with visit attendance and study procedures.   "
27010|NCT02932189|"     Introduction:      It is well established that physical fitness improves muscle performance either in sedentary     people or in athletes. In this regard, specific exercises for respiratory muscles can result     in better functional performance in hospitalized individuals, especially in critically ill     patients in prolonged weaning.      Objectives:      To compare the following variables between intervention and control patients: success in     weaning, free time off ventilator on ICU after weaning, and gain of muscle strength with the     use of the inspiratory muscle training (IMT).      Patients and methods:      Prospective randomized controlled clinical trial. Only individuals on prolonged weaning will     be enrolled. They will undergo IMT or will be managed in a conventional manner. The primary     endpoint will be successful weaning. In addition, other variables such as free time off     ventilator on ICU after weaning and muscle strength will be measured. In addition, mortality     in the ICU, inside the hospital and after discharge will be followed for one year after study     entrance.      Expected results:      According to the working hypothesis, it is expected that the performance of patients     undergoing IMT will be superior to the conventional treatment. Also, their time to mortality     is expected to be longer.   "
27011|NCT02932176|"     The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous     in clinical practice. However, most users have received no formal training in their use or     the interpretation of the returned data. This leads to delays in diagnosis and errors in     diagnosis.      The investigators intend to create a novel machine-learning algorithm to assist clinicians in     the use of this data. This study will allow the investigators to collect sound files from the     use of the devices and compare the algorithms output to established, existing vascular     testing. There will be no invasive procedures, and use of these stethoscopes is part of     routine clinical care.      If successful, this data and algorithm will be later deployed via smartphone app for point of     case testing in a separate study   "
27012|NCT02932163|"     Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the     lower back for at least three months with no known causes. The CNSLBP prevalence is estimated     of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the     patients and the society. Whereas a specific pathology has not been identified for CNSLBP,     mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to     the pain and disability.   "
27013|NCT02932150|"     The primary objectives of this study are as follows:      Part A: To evaluate the steady state pharmacokinetics (PK) of tenofovir alafenamide (TAF) and     confirm the dose of TAF 25 mg tablet given once daily in treatment-naive and     treatment-experienced adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB)      Part B: To evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of     TAF 25 mg once daily versus placebo through Week 24 in treatment-naive and     treatment-experienced adolescents with CHB.   "
27014|NCT02932137|"     The objective of this clinical study is to evaluate the potential effect of anti-infection of     low-does IL-2 in patients with SLE.   "
27015|NCT02932124|"     The aim of this study was to analyse a large CPR database, the German Resuscitation Registry,     to evaluate potential benefits of mechanical CPR devices over manual CPR in adult cardiac     arrest victims. The primary endpoint considered is ROSC.   "
27016|NCT02932111|"     The Irritable Bowel Syndrome (IBS) is defined by a combination of abdominal pain, bowel     dysfunction during recurrent periods of shorter or longer duration. The absence of     well-defined pathophysiological marker requires a clinical definition. The most used are the     Rome criteria III whose version was published in 2006 and version IV under development.      An epidemiological study conducted in 2003 in Europe in 8 countries with over 42 000 people,     found on the basis of questionnaires a prevalence of 11.5% with a diagnosis of IBS of 4.8%.in     the total population; the results of this study were comparable to data obtained in the USA.     A French work of our team at 35 447 healthy adults found a 6.2% frequency. In all these     studies, there is a very large predominance of women (sex ratio near 2), with a preponderance     of subjects of the age group 40-50 years.      IBS economic weight is high, partly due to costs directly incurred by the IBS and the costs     generated by associated diseases: number of visits to the general practitioner, to the     specialist, the prescription and realization of complementary examinations, hospitalization,     purchase drugs and work stoppage.      From a pathophysiologic perspective, IBS is now considered as a multifactorial disease     involving varying degrees, depending on the individual variables, visceral hypersensitivity,     disturbances of digestive motility, impaired sensorimotor way communications between the     gastrointestinal tract and the central nervous system, intestinal micro-inflammation.      Hypothesis of this search is that the osteopathic manipulative treatment (OMT) will improve     the symptomatology of IBS in patients with functional gastrointestinal disorders.   "
27017|NCT02932098|"     Purpose: The purpose of this study will be to test the use of a web-based mobile application     (app) initiated at the time of hospital discharge to engage and monitor patients in order to     efficiently deliver better outcomes. The mobile app will be used to remind patients of     discharge instructions, assess adherence treatment regimens, and evaluate symptoms.      Rationale: Approximately 60% of patients with ovarian cancer have advanced stage disease at     diagnosis, and thus aggressive surgical procedures are often medically necessary. Recent     evidence suggests that nearly one in five patients hospitalized for ovarian cancer surgery     will be readmitted within 30 days of discharge. Patients readmitted within 30 days have a 50%     increase in one-year mortality rates and significantly increased costs of care. In addition,     many of the conditions and complications that led to readmission could potentially have been     avoided with more intensive post-surgical follow-up care. Mobile health technologies can     effectively and efficiently connect patients with their healthcare team and have been shown     to improve treatment adherence and reduce avoidable ER visits and hospitalizations.   "
27018|NCT02932085|"     This study is a randomized, double-blind, and sham-controlled trial to examine the effects of     transcranial magnetic stimulation on the brain of health individuals.   "
27019|NCT02932072|"     Microscopy remains a key indicator in drug efficacy testing performed in the context of     clinical trials for monitoring existing antimalarials or in the context of regulatory     clinical trials for registration of new drugs. It is one of the main diagnostic methods for     malaria diagnosis in general, as in an ideal setting it can provide low-cost accurate     diagnosis, determine the density of parasites in the blood, and accurately differentiate     between different malaria parasite species, characteristics vital to the implementation of     global plans for drug efficacy monitoring. Malaria rapid tests (RDTs), while useful for case     management, do not provide information on the parasite density nor the species     differentiation necessary for research and drug efficacy assessment. Microscopy therefore     retains key advantages over a number of newer technologies, but its reliability is severely     impeded by dependence on high technical competence of the human operators as well as     availability of high quality equipment and reagents. Recent studies have demonstrated the     frequent poor specificity and sensitivity associated with manual microscopy diagnostics in     operational conditions , , . Advances in digital microscopy performance and affordability     have now opened the door to potentially significant improvements in the performance of     malaria diagnostic microscopy, overcoming serious deficiencies in current drug efficacy     assessment, and more broadly in malaria diagnosis and management.      Intellectual Ventures Laboratory (IVL), in collaboration with Global Good Fund (GG), has     developed an initial microscope prototype to support its research into dark field imaging of     unstained malaria slides. The system consists of low cost electromechanical components for     scanning a standard slide, an optical train with a high numerical aperture objective, and an     image capture system. Captured images are analyzed with custom image analysis software     developed at GG/IVL, using algorithms that are designed for automatic malaria diagnosis,     without user input. Additionally, image processing algorithms have been built around     detection of Giemsa-stained malaria slides which is the current standard for malaria     microscopy. Initial results show excellent potential for sensitivity and specificity which     exceeds that of typical manual microscopists in the field. Based on the positive market and     needs assessment in January, 2013, given by stakeholders in the malaria diagnostics     community, GG/IVL are pursuing improvement and integration of this algorithm into a portable     microscope platform with characteristics similar to the prototype microscope already     developed at GG/IVL for dark field imaging. The prototype Autoscope was first tested in field     settings in Thailand in Nov 2014 - Jan 2015 at clinics operated by the Shoklo Malaria     Research Unit (SMRU). The goal of the first field evaluation was to assess the Autoscope in     with respect to its diagnostic performance and also its suitability for harsh conditions     typically encountered in field clinics. Further, user feedback on the design and     functionality was sought. The Autoscope and the accompanying image analysis algorithms have     since been further developed and a new version is now available for testing.   "
27020|NCT02932059|"     The purpose of this study is to determine the respective roles of aging and schizophrenia in     the regulation of metamemory using a sentence construction strategy. 4 groups will be     necessary to comparison:      Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged     controls (≥ 55 years)      The effects of age and the disease could lead to interaction in regulating metamemory. The     effect of age would be aggravated by the disease.   "
27021|NCT02932046|"     Anorexia means loss of appetite. But there is disagreement about whether the appetite is     changed by the disease anorexia nervosa (AN). Appetite is a subjective essential sense, which     is regulated in a complex ensemble between brain, stomach - intestinal system and hormones.     As a direct result of malnutrition, there are many somatic complications caused by the     disease AN. Several of these complications may in itself affect hunger- and satiety     perception. An example of this is delayed gastric emptying. Furthermore, changes in the     hormone systems affects the biological reward system in the brain, which plays an important     role in appetite regulation. There is clearly need for research that could lead to better     treatments for AN. Hunger- and satiety perception has only been studied in a few small     cross-sectional studies with no clear conclusion.      The purpose of the study is to determine whether a visual analog scale measurement can detect     changes in hunger- and satiety perception in a least 30 patients admitted to nutrition for     life-threatening severe anorexia nervosa. It may lead to the first step in the development of     a simple and inexpensive instrument which may prove to be useful in measuring the impact of     new and ongoing treatments of the disease.   "
27022|NCT02932033|"     This prospective randomized trial is performed to analyze the post-operative pain (acute and     chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.   "
27023|NCT02932020|"     In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived     from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an     anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal     stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of     this treatment will be examined by patient reported changes in pain and disability utilizing     validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2     signal related to that reflect inflammation and degeneration.   "
27024|NCT02932007|"     The goal of this pilot study is to explore the efficacy of chloroquine in terminating     persistent and longstanding persistent AF and assess its potential role as a pharmacological     cardioversion agent for the management of AF.   "
27025|NCT02931994|"     Removal and prevention of formation of dental plaque biofilms is one of the current hygiene     regimen to prevent, reduce or even reverse the gingival and periodontal disease condition. In     such endeavors of mechanical plaque removal, tooth-brushing and use of dental floss play an     important role. Gomes et al have presented a modification in the use of knotted floss in     wider embrasure areas. The modification in the dental floss has been done so as to increase     the effective width of the floss. The purpose of this study is to compare the reduction of     the clinical signs of plaque accumulation, gingival inflammation and gingival trauma in the     area the knotted floss technique has been utilized versus the area where conventional     flossing has been utilized in Type I gingival embrasures. Patients' acceptability of the     knotted flossing technique will also be evaluated. This study is part of a larger study     protocol involving different sample groups comparing the knotted floss technique with     conventional dental flossing, use of interdental brushes and unitufted brushes in type II and     type III embrasures as well.   "
27026|NCT02931981|"     Our study aims to evaluate the role of Dickkopf-4 as biomarkers in the treatment of     gastrointestinal stromal tumor.   "
27027|NCT02931968|"     This study is designed to recall all patients who have received a full-arch monolithic     zirconia implant supported fixed dental prosthesis in the University of North Carolina (UNC)     School of Dentistry Graduate Prosthodontic and/or Dental Faculty Practice clinics between     January 1, 2008 to September 1, 2015. The main purpose is to evaluate the biological and     technical complications associated with this form of prosthetic treatment. Additionally     patient centered outcomes will be evaluated.   "
27028|NCT02931955|"     Study Objective Allergies affect up to 20% of the population of developed countries and can     cause substantial individual disease burden. For some allergies, immunotherapeutic regimens     (hyposensitization) have been established, e.g. for insect venom allergies and pollen     allergies. This project aims at identifying the T cell activation potential in vivo from     resting T cells of patients undergoing immunotherapy (IT) via a systems biology approach. For     the participants, it involves blood draws and stool collection as well as gathering some     basic medical information. The participation takes one week for patients undergoing insect     venom IT and three months for patients undergoing pollen IT.      This study is a cooperation project between the Centre Hospitalier de Luxembourg (CHL), the     Luxemburg Institute of Health (LIH), the University of Luxembourg and the Integrated Biobank     of Luxemburg (IBBL).   "
27029|NCT02931942|"     Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and     maturation of T lymphocytes and NK cells. Chemotherapy results in depletion of those cells     and thereby an increased infection rate. A pilot study showed low levels of AA in the plasma     of several patients after chemotherapy for hematological malignancies. AA suppletion could be     beneficial to the recovery of the immune system in these patients. But before an intervention     study can be undertaken, further understanding of changing over time of AA levels and the     relationship with the immune status after chemotherapy is necessary.      Objective: The aim of this pilot study is to evaluate the changing over time of AA levels in     plasma and in leukocytes before and during chemotherapy treatment for several different     groups of patients and compare that to healthy controls. In this way we want to identify the     patients were further interventions could be useful and use the data in the development of an     intervention study for power calculations and to identify the primary endpoint.      Study design: observational study      Study population: There will be 6 different groups of participants in the study: two groups     of patients that receive clinical intensive chemotherapy (acute leukemia and high dose     chemotherapy with autologous stem cell rescue), two groups of patients that receive     relatively mild chemotherapy in outpatient setting (colon cancer and lung cancer) and two     control groups. All participants will be adults and recruited at the MUMC+. In total there     will be 150 participants.      Main study parameters/endpoints: Influence of chemotherapy on AA levels in plasma and in     leukocytes.   "
27272|NCT02928770|"     The purpose of this research study is to test a new approach for treating patients with     obstructive sleep apnea and/or snoring. The new nasal device, nastent (NAS: nasal airway     stent), appears to be a useful alternative or additive treatment.   "
27033|NCT02931890|"     The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric     cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and     subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is     based on the following concepts:        -  Preoperative treatment is associated with better patient compliance than postoperative          regimens        -  Preoperative treatment increases the likelihood of disease downsizing/downstaging and          radical R0 resections        -  Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC          chemotherapy are effective, feasible and safe regimens   "
27034|NCT02931877|"     As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly     well-documented clinical phenomenon, which affect patients' short-term and long-term outcome.     Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac     valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most     commonly used strategy for general anesthesia. At present, it was unknown that which one is     better in providing cerebral protection effect for patients undergoing cardiac valvular     surgery with CPB. The current study aimed to explore the possible difference.   "
27035|NCT02931864|"     Breast cancer is the most common cancer in women in Singapore. Breast cancer survivors     usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or     radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and     anxiety/depression. Currently, there is no study to include both symptom management and     mindfulness training components for breast cancer survivors. And given breast cancer     survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom     management and mindfulness training programme for breast cancer survivors and to determine     its effects on quality of life, symptom distress, psychosocial adjustment, psychological     morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors.     We employ a randomised clinical trial with four study arms (with 47 subjects in each arm)     together with a process evaluation; group 1 (usual care), group 2 (experimental group: five     weekly sessions of online symptom management + mindfulness training programme and usual     care), group 3 (comparison group 1: five weekly sessions of online symptom management     programme and usual care), and group 4 (comparison group 2: five weekly sessions of online     mindfulness training programme and usual care). Subjects will complete questionnaires     measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self-Efficacy Scale,     the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial     Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and     anxiety Depression Scale and Five Facet Mindfulness Questionnaire at baseline (printed     questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and at 24 weeks from     baseline by an online system or printed questionnaires. Individualised semi-structured     interview (15-25 mins) for experimental and comparison groups will be conducted at 24 weeks     from baseline to understand the subjects' experiences of the study programme. Data will be     analysed using SPSS version 24. Baseline demographic and clinical information of subjects in     the experimental, comparison and control groups will be summarised using descriptive     statistics, and will be compared using chi square tests and ANOVA/ANCOVA tests.     Intention-to-treat approach will be used. Repeated measures analysis of variance will be used     to examine the differences on outcome measures among the experimental, comparison and control     groups across study time points. In addition, differences in changes in outcome measures     among experimental, comparison groups and usual care groups will be tested using multilevel     modelling techniques. A p-value smaller than 5% will be considered as statistically     significant. Content analysis will be conducted to analyse the interviews data.   "
27036|NCT02931851|"     Relatives in intensive care units (ICU) are important partners in decision-making in the     treatment of critically ill patients and provide a significant resource in the care and     recovery of patients. Therefore, a professional, educational intervention targeting these     caregivers may have fundamental benefits with little risk. As in other fields, information is     searched in the internet, but this unselected information is often overwhelming and of little     use in this context.      Symptoms of anxiety, stress and depression are common in affected relatives. The majority of     family members report some level of anxiety, depression and stress, sometimes even resulting     in post-traumatic stress disorder (PTSD). Importantly, an association between lack of     information and post-traumatic stress disorder PTSD has been reported. The large number of     potentially affected families poses a particular challenge to healthcare and may cause     substantial secondary costs to national economy.   "
27037|NCT02931838|"     A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated     with BMS-986165   "
27038|NCT02931825|"     Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank     third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening     for people with a high risk for colorectal cancer. But this compliance with colonoscopy is     low (20-40%), it is therefore necessary to develop new strategies to improve compliance.      The purpose of this project is to to offer and evaluate the feasibility and the effectiveness     of a specific surveillance system for high risk people for colorectal cancer      The project will be divided into 2 phases:      Objectives of the first phase:        -  Identify high risk people for colorectal cancer in the department of Indre-et-Loire,        -  Fill in as completely as possible their colonoscopic history in the past 5 years,        -  Estimate the proportion of high risk people for colorectal cancer in the target          population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50          to 74 years).      Objective of the second phase:      Compare the performed colonoscopy rate of high risk people for colorectal cancer without     notion of colonoscopy in the past 58 months following or not (control group) the sending of a     letter reminding the importance of compliance with colonoscopy.   "
27039|NCT02931812|"     This study evaluates the influence of the taste sensitivity, of food preferences and of the     reward system on the energetic balance before and after liver transplantation in cirrhotic     patients and after kidney transplantation in renal failure patients   "
27291|NCT02928510|"     This research trial studies the mechanisms of idelalisib-associated diarrhea in patients with     chronic lymphocytic leukemia, indolent non-hodgkin lymphoma, or small lymphocytic lymphoma     that has come back after a period of improvement. The cancer treatment drug idelalisib     triggers diarrhea in some patients. Studying stool, blood, and tissue samples in the lab from     patients who are given idelalisib may help doctors learn more about the side effects and may     help to treat them in future patients.   "
27040|NCT02931799|"     Patients with Inflammatory Bowel Disease (IBD) are frequently hospitalized, with an increased     risk of repeat hospitalizations within the same calendar year. Given that hospital     readmissions represent a significant burden to patients and the health care system, a     standardised pathway for IBD patients discharged from the hospital can have a significant     impact on reducing readmission rates, healthcare utilization and patient satisfaction. The     primary aim of this study is to evaluate the effectiveness of an IBD post-discharge pathway,     involving post-discharge nurse follow-up and electronic monitoring, in reducing IBD     readmission rates.   "
27041|NCT02931786|"     Investigators researched the effect of two different types of drugs on core body temperature     during magnetic resonance imaging. The hypothesis is in ketamine group, thermo disregulation     is not as distinct as in propofol group, due to its positive effect on thermo regulation   "
27045|NCT02931734|"     The aim of this study is through a randomized clinical trial, double blind, splith-mouth,     evaluate the various types of protocols and clinical efficacy in the reduction or even     elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental     Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil,     Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the     association of all products. Data will be collected, tabulated and submitted to statistical     analysis.   "
27046|NCT02931721|"     Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential     differences depending on the outcome, ie. sperm recovery in consequent microdissection     testicular sperm extraction (MD-TESE).   "
27047|NCT02931708|"     Heart failure is an incapacity to provide adequate blood flow to the others organs, such as     brain, liver and kidney. The patients presents weakness and fatigue of inspiratory muscles,     mainly diaphragm muscle, that contributes to dyspnoea and limited physical capacity in this     patients.      Some methods are being studied to decrease the diaphragm weakness. The diaphragm functional     eletrical stimulation is a new technique, which has been studied to improve the respiratory     muscle strength. Then, the aim of this study is to assess the effects of diaphragm functional     electrical stimulation (FES) on respiratory muscle strength and muscle architecture of     patients with heart failure.      For this the following assessments will be performed before and after stimulation:     manovacuometry to verify the maximum inspiratory pressure and maximum expiratory pressure;     and ultrasonography to assess muscle architecture.      The subjects will be selected by the decompensation in heart failure, with the adequate     elegibility criteria. This study have no control group, because this technique has been     little researched and could be unethical with the patient who won't receive this treatment.      The subjetcs of this research will receive the diaphragm functional electrical stimulation     twice of day for consecutive five days or until the hospital discharge.      Expected results at the end of the protocol with Diaphragm Functional Electrical Stimulation     are: to improve respiratory muscle strength; to correlate with diaphragm muscle arquiteture.   "
27048|NCT02931695|"     QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced,     is associated with an increased risk of torsades de pointes and sudden death. Women are at     higher risk of torsades de pointes, particularly during post-partum and the follicular phase.      The aim of this study is to explore if QTc duration is prolonged during post-partum as     compared to the 3rd trimester of pregnancy   "
27049|NCT02931682|"     With only limited prospective longitudinal data currently available on Creatine Transporter     Deficiency (CTD), its natural history is at present incompletely understood. This     international study is designed to provide additional insights into disease progression, to     characterize how patients perform on clinical neurodevelopmental assessments, and to evaluate     magnetic resonance spectroscopy (MRS) and event-related potentials (ERPs) in patients with     CTD.   "
27050|NCT02931669|"     The perception of disability has changed throughout history, and today, people who previously     did not have a way to communicate are able to express themselves through Augmentative and     Alternative Communication (AAC). However, the potential of AAC is not being fully realised     and devices are often abandoned. It is therefore essential to hear the voice of those who use     it and those who interact with them on a daily basis, in order to find out what the meaning,     value and purpose of AAC is for them. This will support SLTs in directing intervention and     establishing priorities, as well as in advocating for funding and acknowledging the voice of     AAC users. The study uses a qualitative descriptive approach, using thematic analysis to     establish emerging themes from surveys completed by AAC users, family members, health     professionals, teachers, and face to face interviews with children who use AAC.   "
27051|NCT02931656|"     Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with     adverse perinatal outcomes and high risk for chronic disease both for the mother and for the     child. Physical exercise is feasible to diabetic pregnant women and contributes to a better     glycemic control and to decrease adverse perinatal outcomes. However there are no studies     assessing the effects of aquatic physical exercise on GDM control.   "
27052|NCT02931643|"     This study aims to investigate the effect of mixed of herbs and spices on gene expression of     pathways associated with glucose homeostasis, oxidative stress, inflammation and its     interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.   "
27292|NCT02928497|"     The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left     Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for     subjects with non-valvular atrial fibrillation who are deemed not to be eligible for     anti-coagulation therapy to reduce the risk of stroke.   "
27293|NCT02928484|"     The purpose of this pilot study is to evaluate whether a probiotic supplement improves     gastrointestinal (GI) function.   "
27053|NCT02931630|"     The prevalence of overweight and lifestyle related diseases such as cardiovascular disease     (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a     condition characterized by abdominal obesity, high blood lipids, high blood pressure and     elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D.     Dietary fibers and whey protein have independently shown beneficial effects on several of     these risk factors in previous studies. Whey protein is furthermore seen to show positive     effects on bone turnover.      The purpose of this trial is to investigate whether an increased intake of dietary fibers and     whey protein (separately or combined) over a period of 12 weeks will affect the risk markers     of MeS and bone turnover in abdominally obese subjects.      A total of 80 people with abdominal obesity will be included. The design is a randomized,     double blinded, controlled dietary intervention trial. Subjects are assigned to one of four     experimental groups. Each group are provided with test products containing either high or low     whey protein and high or low dietary fibers to replace part of their regular diet. The     subjects are instructed in how to incorporate the test products in their habitual diets in     order to maintain weight stability.      The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing     CVD. PPL is estimated by performing a standardized high fat meal test during which     postprandial level of triglycerides is measured. The authors hypothesize that a diet of high     content of whey protein and high dietary fiber during 12 weeks will induce a reduction in     PPL.   "
27056|NCT02931591|"     This study is aimed to determine if Metformin treatment in children born small for     gestational age (SGA) who are being treated with Growth Hormone (GH) for short stature     improves the response to GH by producing greater concentrations of Insulin-like growth factor     -1 (IGF-1) in the blood.   "
27057|NCT02931578|"     The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.   "
27058|NCT02931565|"     The objectives of this study are as follows:      In patients with primary Type II Achalasia, following a single 5-mg dose of IW-1701,        -  To assess the safety and tolerability        -  To determine the effects on measures of esophageal function by high-resolution impedance          manometry (HRIM)        -  To determine the pharmacokinetic (PK) parameters, Cmax, Tmax, and AUClast   "
27059|NCT02931552|"     The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II)     cognitive-behavioral stress management program through a 6-month RCT with 150     Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving     quality of lie (QoL) and reducing distress, compared to a usual care control group (that is     offered the program at the end of the 6 months). We will test also the effects of the program     on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva).     Trained Latinas, called Compañeras (Companions), who have had breast cancer deliver the     stress management program in-person to Spanish-speaking Latinas with breast cancer.   "
27060|NCT02931539|"     The purpose of this study is to determine if an investigational treatment (Maribavir) is safe     and effective in treating transplant recipient patients with cytomegalovirus (CMV) infections     that are refractory or resistant to treatment.   "
27061|NCT02931526|"     The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of     tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and     examine whether the dosage needs adjustment.      The study will observe two groups of patients respectively and compare the difference between     them. Patients who need to receive CRRT when treat with high-dose tigecycline will be     collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected     in Group non-CRRT.   "
27062|NCT02931513|"     Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by     destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first     line treatment for patients with PBC. However, up to 40% of patients respond inadequate to     this treatment.      sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR     is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR     can predict response to treatment with UDCA in newly diagnosed patients with PBC.   "
27063|NCT02931500|"     To develop machine learning algorithms for the identification of future development of     cardiovascular and metabolic disease   "
27064|NCT02931487|"     Selective biases in attention can be modified by a simple computerized technique: The     Attention Bias Modification Task (ABM) pioneered by MacLeod et al. Cognitive biases may be     one reason depression recurs, and altering these biases should reduce risk of recurrence.     Recently, evidence has supported this hypothesis . The mechanisms by which ABM works are not     well understood. More research is needed to explore how altering an implicit attentional bias     can lead to changes in subjective mood. One possible explanation is that positive attentional     biases are an important component of explicit methods of emotion regulation. The ability to     effectively regulate one's emotions is a fundamental component of mental health and this     ability is impaired in depression. It has also been shown that recovered depressed people     spontaneously show a more dysfunctional pattern of emotion regulation as compared to never     depressed controls. Supporting this, growing evidence implicates dysregulation of a     medial/orbitofrontal circuit in mood disorders. This circuit includes the orbitofrontal     cortex and anterior cingulate cortex, the ventral striatum, the ventral pallidum and medial     thalamus. Components of this circuit are reciprocally connected with the amygdala, which is     implicated in emotional processing in the healthy brain and dysregulated in depression.     Negative emotion processing biases depend on both enhanced bottom-up responses to     emotionally salient stimuli and reduces top-down cognitive control mechanisms, required to     suppress responses to emotionally salient but task irrelevant information. Cognitive     reappraisal and distancing are common strategies to down- or upregulate emotional responses.     Reappraisal is an emotion regulation strategy that involves reinterpretation and changing the     way one thinks about an event or stimulus with the goal of changing its affective impact.     Distancing is a type of reappraisal that involves creating mental space between oneself and     the emotional event in order to see things from a different, less self-focused perspective.     It has been shown that distancing is a strategy that people can improve at over time compared     to reinterpretation. The neural systems which support the explicit regulation of emotion have     previously been characterized and include both lateral- and prefrontal cortex. This frontal     activity is predicted to downregulate limbic circuitry involving the amygdala during passive     viewing of emotional salient stimuli.   "
27329|NCT02928016|"     In a randomized, cross-over designed study, the investigators examined the effectiveness of     the carbohydrate counting method after consumption of mixed meals typical of the Greek     cuisine with various protein and fat contents in a sample of people with type 1 diabetes     (DM1). The investigators also tried to further explore the effects of additional extra virgin     olive oil (11 ml) on the glycemic response.   "
27065|NCT02931474|"     Background:      People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also     alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone     releasing hormone (GHRH) might improve sleep in service members and veterans who have had a     TBI.      Objective:      To see if GHRH can improve sleep in people who have had a TBI.      Eligibility:      Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who     have had a TBI in the past 6 months to 10 years.      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube)      Interview about their mood and alcohol and drug use      Questionnaires about their TBI, mood, and sleep      Participants will have 2 overnight study visits a couple weeks apart. These will include:      Physical exam      Urine sample      Two intravenous catheters placed. Blood samples will be taken throughout the night.      Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the     other.      Spending the night in the sleep lab. Their brain waves will be recorded with electrodes     placed on the scalp.      A questionnaire in the morning about their sleep      Participants will be called a few days after each overnight visit. They will be asked about     how they are feeling and to rate their sleep.   "
27066|NCT02931461|"     The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core     biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle     aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of     the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus     standard 22 gauge needle for diagnosis of lung cancer.   "
27067|NCT02931448|"     In France, the carbon monoxide is one of the first causes of the accidental poisonings with     approximately 8000 cases a year, among which 500 deaths.      The severe forms are translated by neurological disorders even a coma or the death straight     away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate     clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire     corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its     appearance and its gravity are not correlated in the gravity of the initial poisoning,     however the precocity of the treatment tends to decrease its frequency.      Carbon monoxide elimination is made under unchanged form in the expired air. In a spontaneous     way, the half-life in ambient air is of the order of 4 hours. In ventilation in isobaric pure     oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes.      This imposes a fast diagnosis for two reasons:        -  For poisonings with low level, the more the investigators wait to measure the          carboxyhémoglobine (HBCO), the more they risk not to detect it.        -  The oxygen therapy decreases the duration of the poisoning and thus the tissular          suffering.      Actually the risk is important to pass next to the diagnosis and to let leave a patient     without adapted care and without technical intervention to eliminate the source of the     poisoning.      Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO by     realization of gas of the venous blood, which are taken in emergencies, but very often a few     hours after the end of the exposure at the source of poisoning, what is translated by a     disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005,     MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate     the carboxyhémoglobinémie in a not invasive way.      Lot of studies showed the interest of its use in the early screening of carbon monoxide     poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted care.   "
27068|NCT02931435|"     Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing     prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and     disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of     knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in     the United States alone. Many studies report rewarding outcomes for patients, but other     research shows there are many patients that remain dissatisfied post-arthroplasty.      The purpose of this study is to evaluate whether genicular radiofrequency ablation can     relieve chronic post-arthroplasty knee pain.   "
27069|NCT02931422|"     The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a     financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The     study will evaluate 3 cash incentive values and determine percent uptake of testing. A     post-test questionnaire will explore parental satisfaction, mechanisms of incentive     effectiveness and the impact of testing on emotional health and pediatric healthcare     utilization.   "
27070|NCT02931409|"     The purpose of this prospective randomized controlled trial is to determine the effects of     intraoperative lung protective mechanical ventilation using an individual optimal PEEP value     on postoperative pulmonary complications and inflammatory response. A total number of 40     patients undergoing open radical cystectomy and urinary diversion will be enrolled and     randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O will     be performed in control group and an optimal PEEP value determined during a static pulmonary     compliance (Cstat) directed PEEP titration procedure will be applyed in study group. Low     tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will be applyed in     both groups. Procalcitonin kinetics will be monitored during and after surgery until the     third postoperative day as well as postoperative pulmonary complications. Clinical condition     and extrapulmonary complications will be evaluated by the Sequential Organ Failure Assessment     (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be followed.   "
27071|NCT02931396|"     The purpose of this study is to demonstrate the efficacy of FES for trans-tibial amputees.     The investigators aim to demonstrate that providing three months of FES intervention will     increase knee extension strength, increase volume of the residual limb and decrease chronic     and phantom pain.   "
27072|NCT02931383|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (OA) (NCT02905864).     In the parent trial, patients will be subjected to an 8-week diet intervention phase     including a low-calorie diet and dietetic counseling, after which patients will be randomised     to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic     guidance on re-introducing regular foods and a focus on continued motivation to engage in a     healthy lifestyle.      This substudy aims to investigate the impact of, and subsequent change of, joint inflammation     and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation     to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.   "
27330|NCT02928003|"     Chronic post-thoracotomy pain is the most common long-term complication that occurs after a     thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other     factors (genetic, psychological) could have a major and independent role in the development     of the post operative pain.The main objective of this study is to identify genetic and     psychological profile (cognitive and emotional) of patients who develop chronic pain after     lung surgery.   "
27073|NCT02931370|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In     the parent trial, patients will be subjected to an 8-week diet intervention phase including a     low-calorie diet and dietetic counseling, after which patients will be randomised to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.      This substudy aims to investigate any changes in Ultrasound (US) measures associated with the     initial 8-week weight loss intervention.   "
27074|NCT02931357|"     This is a randomized, open label, parallel-groups, multicenter study. The study will be     conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey     flavour gel medical device class IIa.   "
27075|NCT02931344|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).      This substudy aims to investigate any changes in biomarkers associated with the initial     8-week weight loss intervention   "
27076|NCT02931331|"     Regional absolute myocardial blood flow during stress (sMBF) as measured by Positron Emission     Tomography (PET) improves post mechanical revascularization provided there is a baseline     stress induced perfusion defect. Coronary revascularization performed on regions without a     stress induced perfusion defect does not increase the sMBF.   "
28125|NCT02917590|"     Is dual-task obstacle crossing training more efficiently than single-task obstacle crossing     training on the improvement of walking ability, balance ability, and lower extremity muscle     strength in ambulatory subjects with spinal cord injury   "
27077|NCT02931318|"     In this descriptive study, the purpose was to determine the knowledge levels and attitudes of     the people in Nevsehir, Turkey on organ donation.      It has been determined that the people living in Nevsehir do not have sufficient knowledge on     organ donation, they had various concerns on the issue, and they wanted to receive     information from Organ Donation Units. It can be used the exemplification and internalization     in educational curricula about increasing the organ donation.   "
27078|NCT02931305|"     The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a     pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular     disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each     cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched     controls.   "
27079|NCT02931292|"     Obesity is a chronic disease and its treatment requires close follow-up to accurately assess     the efficacy and durability of any treatment strategy. It is widely accepted that bariatric     surgery patients require lifetime follow-up to assess for weight loss, co-morbidity changes,     and nutritional deficiencies.      The study objective was to ascertain efficacy of weight loss and complication rates in 562     consecutive cases of laparoscopic sleeve gastrectomy (LSG) in a single surgeon practice.   "
27080|NCT02931279|"     Prospective, multicenter non comparative and observational study (post-market clinical     follow-up).      Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016     and July 2017.      The inclusion period will be 12 months and the follow-up 24 months   "
27081|NCT02931266|"     Prospective, multicenter non comparative and observational study (post-market clinical     follow-up).   "
27082|NCT02931253|"     The purpose of this study is to see if the study drug metformin will help patients who are     overweight and have atrial fibrillation. This study aims to see if metformin helps patients     stay in normal sinus rhythm after a catheter ablation.      Metformin is investigational for use in patients with atrial fibrillation. Metformin is     approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes     Mellitus. Metformin is used with a proper diet and exercise program to control high blood     sugar, and has been shown to help people lose weight. This study aims to look at the effects     of metformin on weight loss and heart rhythm in patients with atrial fibrillation.   "
27083|NCT02931240|"     A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System,     with 2:1 study vs. active concurrent control group allocation ratio. This study will include     126 patients of which 84 patients will be treated with the investigational device and 42     patients will be included in an active control group.   "
27084|NCT02931227|"     Temperature is one of the vital signs usually monitored in patients of ICUs. Indeed, fever     occurs frequently in ICU especially in brain injured patients and may require targeted     temperature management (TTM) in special case as intracranial hypertension or post cardiac     arrest. In ICU, non invasive device to monitor temperature are not recommended and only     invasive ones are accurate enough for TTM. Arterial pulmonary temperature is still the gold     standard, but esophageal device is currently used in ICU patients.      The goal of this study is to compare accuracy of a continuous noninvasive cutaneous     temperature using zero-heat-flux (ZHF) method to esophageal temperature, arterial temperature     and intracerebral temperature if present for clinical monitoring.      All adults patients admitted in the neurosurgical or surgical ICU are eligible for inclusion     into this study.      Assessment of temperature will be continuously monitored by esophageal probe (MON-A-THERM,     12Fr, COVIDIEN, Dublin, Ireland) (Teso), ZHF sensor (SpotOn, 3M, St Paul, MN, USA) (TZHF)     and, in patients requiring cardiac output monitoring, by femoral arterial catheter     (Pulsiocath PICCO, PULSION, Munich, Germany) (Tart). The correct positioning of the     esophageal probe will be controlled by chest X-ray. The ZHF temperature sensor (TZHF) will be     placed on the forehead as recommend by the manufacturer and connected to the SpotOn monitor.     Intra cerebral temperature (Tbrain) will be obtained with an intracranial probe used as     calibrator for partial pressure of O2 in brain (PbO2, Licox®Combined Oxygen and Temperature     Probe 462 mm device necessary for monitoring severe brain injured patients. The ZHF sensor     will be changed every 24 hours according to the manufacturer's directions for use.     Temperatures will be recorded automatically at a 5-minutes interval via the patient's monitor     with an electronic data acquisition system (Data Collect, Phillips) for a maximum of 5 days.      For each patient included, data recorded will be: demographic and clinical particulars for     each patient; information on hemodynamics, sedative, analgesic and inotropic agents, use of     neuromuscular blockades and their indication, reason of hypo or hyperthermia (spontaneous or     therapeutic), indication and the means used (neuromuscular blockades, external or internal     cooling) in case of Targeted Temperature Management; complications related to the ZHF sensor     application.   "
27085|NCT02931214|"     The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV     doses of GMI-1359 in healthy adult subjects.   "
27086|NCT02931201|"     The purpose of this study is to evaluate whether a semi-quantitative interpretation using the     liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression     during chemotherapy or survival in DLBCL.   "
27331|NCT02927990|"     The new software package is intended to assist the physician in imaging the coronaries during     percutaneous coronary interventions.      This study investigates the amount of contrast used during percutaneous coronary     interventions with the aid of the new software package.      The results of the study will be compared with control group data (before the new software     package was installed or after it was removed) to define a possible contrast reduction.   "
27087|NCT02931188|"     There are currently no studies evaluating the effect of anacetrapib on blood vessel function     and stiffness of the arteries. The REVEAL-Vasc trial will assess whether anacetrapib, in     addition to atorvastatin (LDL-C lowering drug) treatment, results in greater     endothelial-dependent vascular function and aortic stiffness in patients with established     cardiovascular disease, compared to adding placebo.      Participants will be asked to provide a blood sample and pulse Wave Velocity/Pulse Wave     Analysis and Flow Mediated Dilation will be carried out to assess blood vessel function and     stiffness of the arteries. REVEAL-Vasc is an investigator led sub-study of HPS3/TIMI 55:     REVEAL (Randomized Evaluation of the Effects of Anacetrapib through Lipid modification): A     large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among     people with established vascular disease (NCT01252953) which is coordinated by OXFORD CTSU.      No treatment will be received on this sub-study, therefore only participants who have been     enrolled in HPS3/TIMI55 REVEAL in which participants received anacetrapib with atorvastatin     or placebo will be considered for this trial.   "
27088|NCT02931175|"     The study aims to evaluate the potential role of ACTH gel in the management of non-infectious     uveitis.   "
27089|NCT02931162|"     To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.   "
27140|NCT02930694|"     The primary purpose of the study is to investigate the plasma pharmacokinetics and     bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths     of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of     JNJ-54175446 under fasting conditions.   "
27090|NCT02931149|"     To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic     Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to     avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has     demonstrated efficacy in preclinical endoscopic resection models.   "
27091|NCT02931136|"     The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to     investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research     completely independent intellectual property rights neuropsychological test tool for the MCI     due to AD. At the same time, the investigators will study the efficacy and safety of early     treatment of MCI due to AD by Huperzine A in 52 weeks.   "
27092|NCT02931123|"     This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy     with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS     hepatic encephalopathy.   "
27093|NCT02931110|"     This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and     cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics,     and antitumor activity of CBL0137. The study will evaluate CBL0137 administered IV weekly on     Days 1 and 8 of repeated 21 day treatment cycles in subjects with previously treated     hematological malignancies.   "
27094|NCT02931097|"     Gait and balance disorders represent the main motor disability in advanced Parkinson's     disease. These symptoms are less or unresponsive to levodopa treatment and are considered to     be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and     freezing of gait are responsible for high morbidity (fractures, residential health care) and     increased significantly mortality. The pathophysiology of gait and balance disorders is still     poorly understood, but recent data obtained in animals and humans suggest that a degeneration     of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic     locomotor region, could play a crucial role. In line with this hypothesis, low-frequency     stimulation of the pedunculopontine area, thought to increase the activity of the remaining     cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in     advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic     locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over,     controlled study.   "
27095|NCT02931084|"     The natural course after ACL injury is not well described in the literature. Every year about     7000 people, a majority aged 15-30 years old, injure their anterior cruciate ligament (ACL)     in Sweden. About 3500 go through surgical treatment and rehabilitation. Despite the large     amount of research on ACL-injuries, there are still many patients who have unsatisfactory     outcomes regarding instability, decreased activity level, and quality of life, not being able     to return to sport as well as an increased risk for osteoarthritis. The general aim of the     study is to evaluate the natural course and recovery after ACL injury. Specific aims:        -  To evaluate physical, psychological and contextual factors affecting recovery after          anterior cruciate ligament (ACL) injury. Recovery is related both to natural course and          to treatment chosen        -  To evaluate factors affecting the decision for which treatment to choose (ACL          reconstruction and rehabilitation or rehabilitation alone)        -  To evaluate factors affecting the decision for return to sports        -  To study development of knee osteoarthritis after ACL-injury        -  To study epidemiology of acute knee trauma        -  To study risk factors for new injuries after ACL-injury These aims will be pursued by          consequently and prospectively following patients who sustain a new ACL injury in a          multicenter study including approximately 800 patients. Assessment methods will be          questionnaires to patients, orthopedic doctors and physical therapists. A sub-cohort of          130 patients will undergo multiple clinical and functional examination as well as MRIs          and blood, urine and joint fluid samples.   "
27096|NCT02931071|"     Fanconi anemia (FA) is a congenital disease characterized by bone marrow failure and     increased incidence of malignant tumors. The Project pursue the optimization of the     collection of hematopoietic progenitor cells for later use in another clinical trial entitled     Clinical Trial Phase I/II to evaluate the safety and efficacy of the infusion of autologous     CD34+ cells mobilized with mozobil and filgrastim, and transduced with a lentiviral vector     carrying the FANCA gene (Orphan Drug) for patients with Fanconi Anemia Subtype A . The     objectives of this study are, therefore, to assess the safety and efficacy of CD34+ cells     mobilization with mozobil and filgrastim, which is postulated the most efficient for the     collection of CD34+ cells from FA patients.   "
27097|NCT02931058|"     The trial investigates the efficacy of knee-extension exercise prior to total knee     replacement. The participants are randomly allocated to one of three exercise dosages. There     is no control group.   "
27332|NCT02927977|"     The purpose of this randomized clinical trial is to verify the effectiveness of the addition     of the dry needling in individuals with non-specific neck pain who receive a multimodal     physical therapy rehabilitation program.   "
27098|NCT02931045|"     Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors     are essential for platelet activation. Antagonists against the P2Y12 receptor, which are     established in secondary prevention of myocardial infarction, have unexplained     anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced     infection-related mortality compared to clopidogrel, previous standard treatment for patients     with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant     platelet extracellular vesicles. The investigators assume that decrease in infection-related     mortality in patients treated with ticagrelor may be explained by greater inhibition of the     release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected     to identify an additional mechanism of action of ticagrelor, which might contribute to the     observed clinical benefits in patients treated with ticagrelor.   "
27139|NCT02930707|"     Major abdominal surgeries are associated with severe abdominal pain, which can affect     respiratory and cardiac functions, if insufficiently managed. This increases the incidence of     post-operative morbidity.      The objective of this study was to detect the efficacy and safety of magnesium sulphate as an     adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in     patients undergoing total abdominal hysterectomy.   "
28147|NCT02917304|"     The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among     healthy adults over 65 years of age.   "
27099|NCT02931032|"     Oral diseases tend to be exacerbated due to delayed diagnosis. Patients avoid visiting their     dentist even for regular checkups, and develop late stage disease, jeopardizing the treatment     outcome. There is an urgent need for an inexpensive and minimally invasive technology that     would serve as a diagnostic aid, allowing 1) efficient early detection and 2) treatment     customization. Diagnostic modalities based on the detection of volatile organic compounds in     the exhaled air may answer this need.      The proposed research aims at investigating signature molecular patterns of common oral     diseases, as a first step toward the development of a computerized non-invasive diagnostic     breath test, based on the Na-Nose device.      The proposed research will be divided to three distinct stages. Stages 1-2 will serve for the     detection and analysis of Volatile Organic Compounds connected with common oral diseases, and     for the characterization of a specified diagnostic nano-receptor array. Stage 3 will serve     for the clinical testing of the array and as a proof of concept.      In a pilot experiment, headspaces above colonies of S.mutans, S.sanguis, P.gingivalis and     F.nucleatum were trapped and analyzed using Gas Chromatography Mass Spectrometry (GC-MS). A     unique VOC signature, consisting of 20-35 molecules, was detected for each of the bacterial     strains.      These promising results allow the development of an algorithm for statistical detection of     oral diseases by their VOC profile alone. Bacteria and distressed tissues emit unique VOCs,     and additional research is required with other types and strains of bacteria - including     cultivation of samples from active periodontal and carious lesions.      The results of the proposed research may be revolutionary. A simple and non-invasive air     sampling at home or in a drugstore will significantly increase patient compliance and     curability rates, and decrease healthcare expenditure.   "
27100|NCT02931019|"     For better view of fiberoptic intubation, the posture of neck is compared between neck     flexion and extension.   "
27101|NCT02931006|"     50 men will be recruited to this study. Participants will be asked to ingest commercially     available bovine milk. Hormonal profile will be analyzed before and after consumption.   "
27102|NCT02930993|"     This is a single-arm, open-label, one center, dose escalation clinical study, to determine     the safety and efficacy of infusion of autologous T cells engineered to express chimeric     antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent     or metastatic malignant tumors.   "
27103|NCT02930980|"     The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device     during different postures and activities and to understand the source of the sensed motion,     in order to test feasibility for future enhancements in device functionalities.   "
27104|NCT02930967|"     A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand     binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1     positive tumors . In this single-arm, open-label, one center, dose escalation clinical study,     the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric     Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or     metastatic malignant tumors.   "
27105|NCT02930954|"     This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of     combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small     cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or low     activating EGFR mutation abundance.   "
27106|NCT02930941|"     It is estimated that epistaxis results in 4.5 million emergency department visits per year     throughout the United States. Due to the adverse effects of standard treatment options for     epistaxis, tranexamic acid (TXA) may be considered an attractive option. In previous studies,     when used with nasal packing, TXA showed faster time to control of bleeding. The goal of this     study is to determine the efficacy and safety of topical intranasal TXA applied via atomizer     for patients with epistaxis who present to the emergency department.   "
27107|NCT02930928|"     The purpose of this prospective single center study is to investigate if the accuracy of     length based body weight estimation by the already investigated algorithm (CLAWAR) can be     improved by adding another parameter. For this study 500 patients are required to collect     anonymized data (length, weight, age, mid upperarm circumference and patient habitus by     visual estimation) for achieving a power of 80% during statistical analysis. The main     hypothesis ist that CLAWAR's accuracy can be improved.   "
27108|NCT02930915|"     This study investigates the feasibility of using 3D-Printing to manufacture masks used to     immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck.   "
27109|NCT02930902|"     The goal of this clinical research is to learn about the safety and tolerability of Keytruda®     (pembrolizumab) in combination with paricalcitol, with or without standard chemotherapy in     patients who have resectable (can be removed with surgery) pancreatic cancer. In this study,     standard chemotherapy is the combination of Gemzar® (gemcitabine) and Abraxane®     (nab-paclitaxel).      Researchers also want to learn if giving the study drugs before surgery may help to control     the disease. The safety of this drug combination will also be studied.   "
27110|NCT02930889|"     This is a investigator-initiated evaluation of the safety and efficacy of treating benign     prostatic hyperplasia (BPH) by prostatic artery embolization.   "
27123|NCT02929693|"     The investigators performed a multi-centered, randomized, double blinded, placebo-controlled,     prospective clinical trial on the effect of Yiqi-yangyin-jiedu decoction (YYJD), a chinese     herbal medicine (CHM) formula combined with gefitinib to prolong the progression free     survival (PFS) of advanced pulmonary adenocarcinoma patients with activating EGFR mutation     (exon19del or exon21L858R). The investigators plan to enroll 198 cases in 3 years (99 cases     for gefitinib, 99 cases for gefitinib plus YYJD), expecting that combination therapy has a     better efficacy on prolonging PFS, overall survival, improving quality of life(QOL).   "
27346|NCT02927795|"     This is a self-controlled study design enrolling consented COPD patients who will be treated     with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled     consecutively and will be followed over an observational period of approx. 6 weeks.   "
27138|NCT02930720|"     Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to     urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about     25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and     obstetric history. SUI is the complaint of involuntary leakage on activities which involves     inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic     floor movement is coordinated with the diaphragm, it moves caudally while inhaling and     cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor     is correlated to pelvic floor normal and efficient function. in order to maintain continence     while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory,     timing and force. observing the Urinary bladder by trans abdominal ultra sound (TAUS) was     found as a valid and reliable way to estimate pelvic floor sagittal displacement and     function.   "
27111|NCT02930876|"     Cancer causes 8.2 million deaths each year, with an estimated worldwide cost of $895 billion.     Pharmacological treatments provide improvements in expected survival and symptoms, but at     cost of a high rate of toxicities and increased time spent by patients away from their homes     and families during treatment. This is particularly important for patients with advanced     disease as the timeframe at stake relates to their last months of life.      Sarcopenia (i.e. loss of muscle mass together with decreased functional capacity) has been     widely reported as an important prognostic factor in advanced cancer, with impact on     survival, toxicities, response to treatment and other patient-centered outcomes (such as     functional capacity, quality of life and fatigue).      Sarcopenia is a term first used in 1988 by Rosenberg, meaning an age-related loss in skeletal     muscle mass and function. It was derived from the greek: sarx = flesh and penia = loss. In     2010, a European Consensus defined sarcopenia as a triad of muscle mass loss, decreased     functional performance and muscle strength. It has been reported as a hallmark of cancer,     with impact on prognosis, response to treatments, side effects of chemotherapy and recovery     after surgery. The prevalence of sarcopenia in advanced cancer seems to vary according to     gender, stage, primary tumor location and treatments, being present in about 28 to 67% of     patients.      Exercise, in particular resistance training, is one of the most powerful ways of increasing     muscle mass and evidence from elderly patients suggests that it is among the most promising     interventions for sarcopenia. There is evidence that resistance training can be effective but     evidence is still scarce for patients with advanced disease. Historically there have been     some concerns regarding safety and efficacy for oncologic patients, and though evidence     suggests that resistance training is one of the most preferred forms of exercise by patients,     the effectiveness of resistance training alone on sarcopenia in patients with advanced cancer     remains unknown. Another question is whether home (which seems to be the patients' preferred     location for exercise) produces better results than hospital (the traditional location).   "
27112|NCT02930863|"     This study will evaluate the effectiveness of an automated voice prompting system on post     operative hypoxia within the Postoperative Anesthesia Care Unit (PACU). This will be done to     detect an improvement of the patient experience and provider care through a decrease in the     number of peripheral capillary oxygen saturation (SpO2) monitor alarms via the patients own     ability to follow the instruction and improve their SpO2 levels.   "
27113|NCT02929823|"     The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective     in promoting corneal epithelial wound healing in conditions associated with corneal     epithelial disorders.   "
27114|NCT02929810|"     Emerging evidence suggests that approximately 30% of the US adult population sleeps less than     7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular     diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep     deficiency can be corrected and its detrimental health consequences potentially reversed. The     purpose of the present proposal is to investigate the cardiovascular and metabolic effects of     sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual     short sleep.   "
27115|NCT02929797|"     A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the     pancreatic cancer patients treated with adjuvant chemotherapy.   "
27116|NCT02929784|"     The purpose of the study is to investigate the possibility of treating Hemiplegic Shoulder     Pain (HSP) using transcranial direct current stimulation (tDCS) in patients following stroke.      The secondary aims are to see if this treatment affects motor function of the upper limb, to     asses the different types of HSP and whether there is any correlation to the location and     extent of the stroke.   "
27117|NCT02929771|"     This study will assess the impact of virtual reality (VR) in decreasing procedural pain     related to subcutaneous port (SCP) access in children with cancer. The study is a     pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with     detailed information on the feasibility of implementing our trial protocol in a future     multi-center RCT as well as preliminary estimate of VR treatment effect on children with     cancer undergoing SCP access, including child and parent factors potentially associated with     VR distraction treatment efficacy.   "
27118|NCT02929758|"     The purpose of this prospective, within-subject randomized cross-over design study is to     determine if a computer training program (Speed of Processing Training - SOPT) improves safe     pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a     virtual reality pedestrian environment. Pedestrian injury poses significant risk to healthy     older adults and patients with Parkinson's disease. Several age-related changes, including     slowing of visual processing speed, increase risky pedestrian behavior. This study will     determine if SOPT improves pedestrian behavior in patients with Parkinson's disease and     healthy older adults and evaluate the persistence of the SOPT training effects.   "
27119|NCT02929745|"     The purpose of this study is to understand how genetics play a role in psoriasis.     Specifically, a genetic allele HLA-Cw6 is known to be associated with psoriasis, and this     study aims to find out how it affects genetic and protein expression in patients with     psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry     and RNA-sequencing protocol.   "
27120|NCT02929732|"     Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common     neurological sensorimotor disorder that typically impairs sleep and quality of life, likely     consequent to a central dopaminergic dysfunction associated to brain iron deficiency.     Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are     often associated with micro-arousals that contribute to sleep fragmentation and repeated     increases of blood pressure and heart rate throughout the night, thus representing an     increased risk for hypertension and cardiovascular diseases (CVD).      Willis-Ekbom disease affects people with higher cardiovascular risk factors, such as advanced     age, obesity, diabetes mellitus and hypercholesterolemia. However, previous observational,     cross-sectional or longitudinal population-based studies on the association between RLS and     CVD and hypertension showed controversial results.      While the pathophysiology of RLS is yet to be elucidated and is likely multifactorial, one     theory involves a reduction in dopaminergic outflow to the preganglionic sympathetic neurons     in the dorsal horn of the spinal cord. Dopamine inhibits preganglionic sympathetic neurons,     therefore a reduction in dopamine may in turn increase sympathetic outflow.      Based on this notion, the investigators hypothesize an increase of sympathetic autonomic     activity in Willis-Ekbom disease responsible for the recurrent increase in blood pressure and     heart rate during sleep, which may play a role in increasing the risk of cardiovascular     diseases.      The aim of this study is to analyze the autonomic nervous activity in patients with WED     compared to healthy volunteers controls. The investigators will measure primarily the cardiac     sympathetic activity by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy and     secondarily the sympathetic nerve activity by the microneurography, the plasmatic pro     inflammatory biomarkers and urinary catecholamine levels and the circadian variation of blood     pressure and heart rate as assessed by the 24-hour ambulatory blood pressure monitoring.   "
27121|NCT02929719|"     Therapeutic equivalence and safety study   "
27122|NCT02929706|"     NUDT15 R139C was comfirmed to be associated with thiopurine-induced leukopenia inflammatory     bowel disease (IBD) cohort.The present study aim to explor the following questions:can     optimizing thiopurine dose by NUDT15 genotype reduce thiopurine-induced leucopenia?What is     the influence of this optimizing strategy on clinical outcome?Thus,we conduct a randomised     controlled study.Subject in the conventional group detect NUDT15 genotype before thiopurine     use and optimise dosage according to the genotype.While the subjects in the control group     follow the conventional monitor strategy.The primary endpoint was the rate of leukopenia.The     secondary endopoint was the efficacy of thiopurine.The follow up duration was 1 year.   "
27124|NCT02929680|"     The purpose of the Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract     Infection (LRTI) Panel BioFire Study #DX-SDY-024947 is to collect data in support of the     proposal to the FDA to support the classification of the LRTI panel as an in vitro diagnostic     device for the diagnosis of lower respiratory tract infections. The study will enroll up to     1500 specimens across at least 3 study sites of sputum and bronchoalveolar lavage (BAL)     specimens that are left over as excess from routine clinical care. Additionally, the study     will collect residual whole blood or blood fractionation to evaluate the utility of     procalcitonin (PCT) as an additional test to diagnose lower respiratory infection when it is     available. Enrolled sputum and BAL specimens will be run on the FilmArray LRTI panel. If     residual whole blood or blood fractionation is available it will be sent to BioFire     Diagnostics, LLC where they will perform PCT testing. All specimens will be excess from     routine standard of care testing.   "
27125|NCT02929667|"     Sudden unexpected death in epilepsy patients (SUDEP) is devastating outcome for some patients     with epilepsy. It ranks second only to stroke among neurological diseases in years of     potential life lost. Patho-mechanisms of SUDEP remain not well understood, however peri-ictal     respiratory dysfunction likely plays an important role in many cases.      Literature supports a critical role for the serotonergic system in central control of     ventilation. Serotonin neurons in the raphe nuclei of the brainstem sense rising carbon     dioxide and low pH, thereby stimulating breathing and arousal. These responses may serve as     mechanisms that protect against asphyxia, particularly during sleep or the post-ictal state.     In mouse models of seizure-induced sudden death, pre-treatment with selective serotonin     reuptake inhibitor (SSRI) agents prevents death following seizures. Hence, the investigators     hypothesize that a subset of drug resistant epilepsy patients who have impaired central     chemo-responsiveness have a greater degree of peri-ictal respiratory depression, therefore a     higher risk of SUDEP. The investigators further hypothesize that fluoxetine will improve     central chemo-responsiveness and therefore will reduce peri-ictal respiratory depression.   "
27126|NCT02929654|"     To investigate whether novel insight features in new BGMs can improve glycemic control.   "
27127|NCT02929641|"     When a polyp is found, it woulf be recorded by a white-light and OE1 model with magnification     for assessing and predicting its histology. After that, its really histology will be reported     by an pathologist.   "
27128|NCT02929628|"     Patients with an implantable electrical nerve stimulation system Patient criteria included:     over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition＞2.0;an ability to     walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore ＞1 for     UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases     such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials.     Subjects participating in other clinical trials related or not related to these trials were     not chosen.   "
27129|NCT02930837|"     To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours     after onset of stroke symptoms in Chinese patients with acute ischemic stroke   "
27130|NCT02930824|"     Investigators will conduct a comparative effectiveness study of genotype-supported vs.     conventional PPI dosing. Patients presenting with Gastroesophageal Reflux Disease (GERD) or     dyspepsia symptoms and either 1) being initiated on proton pump inhibitor (PPI) therapy or 2)     with continued symptoms on current PPI therapy will be recruited from gastroenterology     clinics and randomized to a genotype-supported versus conventional PPI therapy management     strategy.   "
27131|NCT02930811|"     Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million     people around the world and about 7 million people in France. Morbi-mortality from     cardiovascular events is increased in this population. Intermittent claudication is the most     common clinical feature of PAD.      Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type     5, is well tolerated, largely used in impotence and has interesting clinical delay and     duration of action in the concept of a potential use in claudication.      For patients agreeing and signing informed consent, randomisation of treatment     (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment.     The experimental drug will be delivered for a 1 month treatment. First follow up visit at     month one will focus on tolerance, compliance and eventual side effects. If no major side     effect is found the study drug will then be delivered for an additional 2 months. Patients     will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent     indication for revascularisation and addressed for revascularization if needed. In parallel     focus on tolerance, compliance and eventual side effects will be done. If no major side     effect is found, the study drug will be delivered for an additional 3 months treatment. Third     and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months     after the end of experimental drugs).   "
27132|NCT02930798|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
27133|NCT02930785|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
27134|NCT02930772|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
27135|NCT02930759|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
27136|NCT02930746|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
27137|NCT02930733|"     Serratus plane block was first described in 2013 by Blanco and designed to primarily block     the thoracic intercostal nerves. And this block provides sufficient analgesia lateral     anterior and posterior part of thoracic wall.Increased use of ultrasound guidance for     regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by     Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application     and less adverse effects than neuroaxial blocks, has been defined after these blocks and has     taken its place in the literature.In spite of the insufficient randomized clinical trials in     the literature, SPB has been reported for many cases such as thoracoscopy, shoulder     arthroscopy, breast surgery and axillary lymph node dissections, and the results are     promising. The aim of this study is to determine effectiveness of ultrasound guided bilateral     serratus plane block in patients undergoing breast reduction surgery.      Main outcome measures: The primary endpoint is postoperative opioid consumption.      Secondary endpoints are visual analogue pain scores, opioid related side effects.   "
27141|NCT02930681|"     Glucosanol had previously been proven to be effective in aiding weight loss and weight loss     maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was     effective in aiding weight loss and also has evidence on reducing post-prandial glucose     levels. This study is to enrich the existing evidence on dose-dependent post-prandial glucose     effects of Glucosanol   "
27142|NCT02930668|"     It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing     weight in the overweight and obese. The present study aims at expanding the data concerning     the weight management effect of Glucosanol™ in overweight and moderately obese population.   "
27143|NCT02930655|"     The primary purpose of this study was to assess the safety and tolerability of lucerastat in     adults with Fabry Disease receiving Enzyme Replacement Therapy (ERT).      The secondary objectives were to investigate the effects of lucerastat on plasma and urine     levels of biomarkers, to assess its effects on renal and cardiac functions and to determine     the pharmacokinetic profile of lucerastat at steady-state.   "
27144|NCT02930642|"     The objective of this study is to determine the relations among food insecurity status,     obesity, and impulsive food choice patterns and to test the extent to which a mindful eating     strategy reduces impulsive choice for food. The central hypothesis is that food-insecure     individuals will demonstrate more impulsive food choice patterns and demonstrate a greater     likelihood of obesity than individuals who are food secure. Two specific aims are proposed:      Specific aim #1: Determine the relation between food insecurity, obesity, and impulsive food     choice patterns in women. The working hypothesis is that food-insecure individuals,     especially those that are obese, will exhibit more impulsive food choice patterns than     food-secure individuals.      Specific aim #2: Determine the efficacy of an extended mindfulness-based eating strategy on     impulsive choice patterns among food insecure women. The working hypothesis is that mindful     eating will reduce impulsive food choice patterns relative to baseline and control     conditions, and will persist to follow-up. The investigators expect mindful eating to reduce     impulsive choice compared to control conditions, despite food security status.   "
27145|NCT02930629|"     The purpose of this study is to assess the incidence of residual block in patients arriving     in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received     neuromuscular blocking drugs (muscle relaxants). Residual block (decreased motor function)     due to residual levels of muscle relaxants is associated with increased morbidity.   "
27146|NCT02930616|"     Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer.     Precisely surveillance of patients with GIM may result in early detection and improved     prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all     patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8%     in those patients.   "
27147|NCT02930603|"     A Longitudinal Study of Function and Participation in Life Activities of Patients with     Developmental Disabilities   "
27148|NCT02930590|"     Pressure ulcers are severe injuries and wounds causing a substantial burden on patients,     caregivers, and on healthcare systems worldwide. There is common agreement, that effective     pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in     individuals at risk. Besides risk assessment and repositioning the use of special pressure     ulcer preventive support surfaces are the key interventions in pressure ulcer prevention.     Pressure ulcer preventive support surface modify the degree of skin and tissue deformation     and/or skin temperature and moisture. Therefore, an association between the type and working     mechanism of a pressure ulcer support surface and skin function after loading is highly     likely. Furthermore, such a relationship may be used to characterize and/or to quantify the     performance pressure ulcer support surfaces in terms of skin protection. The overall aim of     this explorative study is to measure skin responses of the two most common pressure ulcer     predilection sites (heel, sacral skin) after two hours loading on three different support     surfaces and the sternal skin (control area).   "
27149|NCT02930577|"     This study evaluates the factors associated with treatment adherence in substance users.     Differences in the level of adherence to treatment according to patient-related factors,     addiction and treatment are analyzed. The individual effect of each factor on treatment     adherence is assessed.   "
27150|NCT02930564|"     The Challenge study is a prospective, open label, pilot trial in patients in deep remission     on dietary maintenance therapy.      The purpose of this study is to determine whether they can consume some of the products that     were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to     evaluate if low dose exposure is harmful.   "
34826|NCT02829905|"     Study will develop, validate and pilot measures to assess quality of experiences of     mammography. Pilot data collection and analysis will investigate modifiable factors most     important in determining quality of patient experiences of mammography.   "
27153|NCT02930525|"     Procedural sedation is an established and safe intervention and is widely used in diagnostic     and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory     system such as upper airway obstruction, hypoventilation and apnea are frequent adverse     events. We postulate that respiratory instability is less frequent in patients high flow     nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in     pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of     HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper     gastrointestinal endoscopy under pediatric procedural sedation (PPS).   "
27167|NCT02930343|"     RA (Rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in     destructive arthritis if not treated rapidly. Inspite of various advances in field of early     diagnosis and treatment of RA, there is still a need for better understanding of the efficacy     and safety of various combinations of conventional DMARDS, and to rank them in order     accordingly, so as to give a clearer vision for further management of RA once MTX monotherapy     fails, so as to achieve remission as soon as possible. The study will be conducted at the     Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical     Education & Research). patients who fail methotrexate monotherapy will be randomised to 2     treatment arms - either a combination of Sulfasalazine (SSZ), Hydroxychloroquine (HCQ) and     Methotrexate (MTX) or Leflunomide (LEF), Hydroxychloroquine (HCQ) and Methotrexate (MTX)   "
27154|NCT02930512|"     Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk     of fracture, particularly hip fracture whose complications and postoperative mortality appear     to be higher than in the general population.      This increased risk of fracture is due partly to an increased risk of falling, and secondly     to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis     concluded that patients with IPD have lower BMD than healthy controls. Prospective studies     also showed rapid bone loss in these patients compared with controls. The association between     low BMD and IPD seems dependent on the severity and duration of the disease even if some data     are contradictory. Various mechanisms may explain this bone loss including weight loss,     malnutrition and a low level of physical activity. However, enrollments in these studies are     often weak and it is difficult to conclude on the real impact of these factors on bone loss     in the IPD. The main objective of our study is to assess and prioritize from these various     bone loss mechanisms. Bone assessment by peripheral quantitative computed tomography (pQCT)     will also assess the impact of various risk factors on bone strength parameters. The     prevalence of vertebral compression fractures in the IPD, at this day unknown can be     evaluated. This study will also estimate the prevalence of vertebral compression fractures in     the IPD.   "
27155|NCT02930499|"     The purpose of this pilot study is to compare the incidence and rate of wound healing in     subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid     plus compression therapy as compared to standard care. The study also intends to follow the     subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.   "
27156|NCT02930486|"     Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight     suture endobutton and one tricortical 3,5 mm syndesmotic screw.   "
27157|NCT02930473|"     This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing     on the nursing diagnosis Anxiety. A randomised controlled trial will be carried out to do     so.   "
27158|NCT02930460|"     Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel     Positive Airway Pressure: AirCurve 10 VAutoTM   "
27159|NCT02930447|"     Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in     plastic surgery. However, only pilot studies and retrospective uncontrolled trials have     reported the potential benefits of autologous glue treatment up to now. Therefore, a larger,     blinded, randomized and placebo-controlled clinical trial would be useful to determine     whether platelet-rich plasma is safe and effective in abdominoplasty procedures.      Currently, there are pharmacological options such as artificial fibrin glues composed of     homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a risk     of transmissible diseases and may induce allergic reactions. Therefore, autologous glues,     which are fully made of blood components from the patient itself (autologous fibrinogen     contained in PRP and autologous thrombin) represents a safe alternative to artificial     biological glues.      Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an     autologous activated thrombin serum, on the other hand, in a safe and rapid manner.     RegenKit®-Surgery is a CE-marked class IIb medical device.      This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared     with RegenKit®-Surgery when used in reconstructive abdominoplasty.   "
27160|NCT02930434|"     The purpose of this study is to evaluate vitamin D (VD) deficiency in the population of     Chilean Antarctica and evaluate the efficacy and safety of VD supplementation to decrease VD     deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health     risk in the inhabitants of Chilean Antarctica.   "
27161|NCT02930421|"     The primary aim of this clinical study is to investigate if exercise training can improve     exercise capacity and quality of life in dyspneic mild chronic obstructive pulmonary disease     patients.   "
27162|NCT02930408|"     Steinert's disease is an orphan disease. The prognosis of patients with this disease is     conditioned by cardiac involvement. Search an early stage alterations in contractile function     in subjects suffering from dystrophy would detect patients at risk of sudden death. The first     stage of work is to validate the tools to detect early stage of infringement systolic     function in a population of patients with myotonic dystrophy.   "
27163|NCT02930395|"     In the past 20 years, the incidence of concussion in direct contact sports has significantly     increased. The incidence of concussion in rugby players ranges between 8 to 17 episodes /     1000 playing hours. A recent study published by the French Rugby Federation (FFR) and the     National Rugby League (LNR) showed similar results. The latter study was performed analyzing     the French TOP14, which includes 14 teams participating in professional rugby     championships. At least two concussions were diagnosed each week. Despite the recent     evidence, cognitive assessment remains the only means to determine whether or not players     experiencing concussions can return to the game or not.   "
27164|NCT02930382|"     We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years     after myocardial infarction (MI) in primary prevention.      Only the ejection fraction of the left ventricle (LVEF) is used as a tool for risk     stratification of sudden death after myocardial infarction.      Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after     MI was predictor of sudden death.   "
27165|NCT02930369|"     The purpose of this study is to determine the effects of two different internal limiting     membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery     measured by optical coherence tomography (OCT).   "
27166|NCT02930356|"     This study is intended to measure hepatocyte growth factor levels in smokers and non smokers     with periodontitis before and after non surgical periodontal therapy.   "
27169|NCT02930317|"     Efficacy, Safety and Pharmacokinetics Study of a rFVIII in Chinese subjects with Hemophilia     A.To assess efficacy and safety of rFVIII administered as treatment and as on-demand therapy     in adult and adolescent (12-65 years) patients with severe or moderately severe Hemophilia A.     To determine the pharmacokinetic (PK) parameters of rFVIII.   "
27170|NCT02930304|"     Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is     considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the     forearm, especially extensor carpi radialis brevi.      The aim of this study is to The compare the short-term effects of different physiotherapy     approaches on pain, function and grip strength in the rehabilitation of patients with lateral     epicondylitis.   "
27173|NCT02930265|"     It has been known that liraglutide reduces infarct size, improved left ventricular function,     reduce myocardial stunning, and play a protective role in myocardial ischemia-reperfusion     injury for patients with acute myocardial infarction. But it is not sure whether liraglutide     can benefit patients with ischemic cardiomyopathy. This study aim to explore the effect of     Liraglutide in improving cardiac function for patients with ischemic cardiomyopathy.   "
27174|NCT02930252|"     The purpose of this study is to compare the duration of stent patency of a covered vs. an     uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction     in patients with inoperable extrahepatic malignant biliary obstruction.   "
27175|NCT02930239|"     A randomized control trial where subjects following an anterior cruciate ligament     reconstruction will be randomized to either a control group who will receive the normal     rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using     the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be     added to the existing care received at Linkoping University Hospital 2 weeks post-surgery,     while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait     analysis (with the Qualisys software), self-reported function questionnaires and a clinical     examination.   "
27176|NCT02930226|"     Assess the safety of single infusions with RePlas FDP product at increasing fixed doses   "
27177|NCT02930213|"     In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients     were measured every 2 hour for 168 h .   "
27178|NCT02930200|"     The primary long-term objective of this research is to reduce smoking relapse through the use     of automated mobile smoking cessation interventions that tailor content (e.g., treatment     messages/materials) in real-time based upon currently present symptoms. The primary     short-term objective of this pilot study is to determine the initial utility of a novel     smartphone based smoking cessation intervention compared with standard in-person smoking     cessation clinic care and the free National Cancer Institute (NCI) QuitGuide smoking     cessation application. The current pilot study is a 3 armed randomized clinical trial that     aims to determine the initial utility of a novel smartphone based smoking cessation     intervention compared with standard in-person smoking cessation clinic care and the free NCI     QuitGuide smoking cessation application.   "
27179|NCT02930187|"     Evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3),     PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI     and ACR-EULAR criteria for remission in routine care.   "
27180|NCT02930174|"     This study is being done to further the investigators' knowledge of the EIT system and to see     if measures between two non-invasive ventilation systems routinely used clinically are     equivalent.   "
27181|NCT02930161|"     The study is designed to assess the safety and efficacy of different doses and dosing     regimens of Runihol, tablets, enteric coated, produced by NTFF POLYSAN (Russia), in     prevention of liver disease progression in patients with non-alcoholic fatty liver disease     and metabolic syndrome.   "
27182|NCT02930148|"     the aims of the present study is to test the PEGASO system in real life conditions in     Lombardy (Italy), England and Scotland (UK) and Catalonia (Spain), as well as to assess     changes in teen-agers' awareness and lifestyles after the use of PEGASO system. Specifically,     the investigators aim to:        1. To test the usability of PEGASO platform        2. To pilot approaches to testing the effectiveness of the system to:             1. Evaluate the increase of knowledge/awareness about healthy habits             2. Assess behavioural change in lifestyle, and specifically on target behaviours In               particular, the pilot study will help to assess likely recruitment and retention in               a controlled trial, to test the acceptability and utility of assessment procedures,               to obtain estimates of effect size and variability to power a future substantive               study   "
27183|NCT02930135|"     The aim of this study is to compare the clinical and radiographic success of indirect pulp     capping of vital young permanent teeth with deep caries using two-step antibacterial bonding     system versus conventional one.   "
27184|NCT02930122|"     Injury to the knee during sports participation often involves partial or full detachment of     the anterior cruciate ligament (abbreviated as ACL). ACL tears cause pain, swelling and     inflammation. While the swelling and inflammation usually goes away in time, individuals with     ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often     surgery can repair or replace the ACL within the joint, allowing individuals the ability to     walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the     knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for     reasons which are not well understood.      In this research study, the investigator hopes to reduce the initial pre-operative pain. The     reduction of pain will allow for earlier movement of the knee joint and preparation for     surgery. The investigator is interested to see if the use of Kineret does decrease the risk     of developing arthritis in individuals with ACL injuries by treating them within 1-7 days     after their injury.   "
27185|NCT02930109|"     A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of     relapsed or refractory acute leukemia.   "
27186|NCT02930096|"     To evaluate the pulsatility index changes after setting supine position in non brain- injured     patient under general anesthesia.   "
27187|NCT02930083|"     To improve activities of daily living (ADL) and social functions is the important treatment     plans and goals in participants with schizophrenia. Precise and effective measures of ADL and     social functions are critical for clinicians to set up appropriate treatments plans, follow     up participants' changes, and understand participants' progress. Three common measures of ADL     and social functions used in participants with schizophrenia were the Comprehensive     Occupational Therapy Evaluation Scale (COTES), the Activities of Daily Living Rating Scale     third ed. (ADLRS-3), and the Social Functioning Scale. To investigators' knowledge,     psychometric properties of these assessments have not been examined in participants with     schizophrenia. Therefore, the purpose of the study is to (1) examine internal consistency and     construct validity of these 3 assessments (the COTES, the ADLRS-3, and the Social Functioning     Scale); and (2) calculate missing rate of self-report assessment (the ADLRS-3 and the Social     Functioning Scale). Investigators expect that these results of internal consistency,     construct validity and/or missing rate will provide empirical evidence for using these three     measures in both clinical and research setting.   "
27188|NCT02930070|"     The new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general     wards. Despite an alternative process by using a simplified qSOFA score, many patients may     still be left out. Whether these patients matter or not is unknown. This prospective cohort     includes patients from ten general wards with high incidence of infection during a     consecutive half year, obtains qSOFA and SOFA score, follows up prognostic data, therefore to     compare patients under different groups, eventually to evaluate the diagnostic accuracy of     qSOFA score in diagnosis of sepsis.   "
27189|NCT02930057|"     The purpose of this study is to examine the potential changes in levels of pain, quality of     life (QoL) and activities of daily living (ADL) observed when transforaminal epidural steroid     injection is administered in conjunction with pulsed radiofrequency treatment of the lumbar     dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring side     effects) of the treatment is determined.      The study hypothesis is that the application of transforaminal epidural steroid injection     (TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar     dorsal root ganglion would increase the treatment response of PRF and thereby provide a     measurable difference in the pain scores, quality of life and activities of daily living for     the patients suffering from chronic lumbosacral radicular pain.   "
27190|NCT02930044|"     The purpose of this study is to determine whether adult DKA patients who present to the     emergency department treated with early subcutaneous long acting insulin versus standard care     receive a shorter total duration of intravenous (IV) insulin infusion.   "
27191|NCT02930031|"     In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to     enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous     eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in     skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may     alter immune cell responses following exercise-induced muscle microtrauma.   "
27192|NCT02930018|"     The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the     neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic     stroke (AIS) with a small established infarct core and with good collateral circulation who     are selected for endovascular revascularization.   "
27193|NCT02930005|"     This study evaluates the feasibility of administering meclofenamic acid or pentosan     polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic     disorder. Half of participants will receive meclofenamic acid, while the other half will     receive polysulfate sodium.   "
27194|NCT02929992|"     The investigators propose the Delivery Optimization for Antiretroviral Therapy Study - The DO     ART Study - a prospective randomized study of strategies to optimize community-based ART     initiation, monitoring and resupply among HIV-positive persons in South Africa and Uganda.     The investigators will work closely with community members, stakeholders, local providers,     and the local Department of Health (DoH) to integrate the community-based ART delivery with     HIV clinics, pharmacies and labs. Following community sensitization, participants will be     recruited through community-based HTC and HIV clinics. HIV-positive persons not engaged in     care will receive point-of-care CD4 testing to determine ART eligibility. HIV-positive     persons who are eligible for ART by national guidelines will be randomized to one of three     ART delivery arms: (i) Home ART initiation and mobile van ART monitoring and resupply, (ii)     Hybrid model with clinic ART initiation and mobile van ART monitoring and resupply, and (iii)     Clinic ART initiation, monitoring and resupply - the current standard of care (SOC)   "
27208|NCT02929602|"     Opioid analgesics prescribed by dentists may contribute to the larger national issue of the     use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the     use of opioids. This study used both dentist and patient input to evaluate the use of opioid     and over-the-counter analgesics following one of seven coded common dental procedures. The     study includes a five day patient follow up assessment of the effectiveness of the analgesic.     Baseline questionnaires were completed by eligible participants, and they responded to the     day 5 follow up questionnaires.   "
27195|NCT02929979|"     The project will examine whether a computerized neuroscience-based cognitive training program     can improve cognitive functioning and recovery outcomes among Veterans with Alcohol Use     Disorder and co-occurring PTSD. Information from this study will help determine the     malleability of cognitive dysfunction, an established risk factor for poor recovery outcomes     in this population. Improved functional outcomes can decrease risk of chronic impairment and     ultimately help affected individuals live richer, more productive lives. Web-based treatment     technologies may increase the reach and impact of treatment, and foster patient recovery in     cases where staffing, space, acceptability of counseling, and transportation are barriers.     Findings may also support expanding use of existing, highly-accessible cognitive remediation     technologies to other vulnerable clinical populations.   "
27196|NCT02929966|"     The investigators will examine the effect of introducing palliative in patients with     end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not     deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators     will randomly assign patients who receive either early palliative care integrated with     standard respiratory care or standard respiratory care alone.      Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome     will be the change in the quality of life and symptoms at 12 months.   "
27197|NCT02929953|"     The aims of this study are:        1. To assess the prevalence of prematurity, especially early prematurity, among T1D          patients, and compare it to the prematurity prevalence among the non-diabetic general          population in Israel.        2. To characterize epidemiological and clinical factors that differ between premature-born          patients that developed T1D and those that have not, including the nutritional and          therapeutic properties in NICU.   "
27210|NCT02929576|"     The purpose of this study is to evaluate and compare the clinical benefit and safety of     treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy     versus placebo with paclitaxel in patients with locally advanced or metastatic,     diagnostic-positive, triple-negative breast cancer (TNBC).   "
27958|NCT02919787|"     This study evaluate the additional effect of adding chemotherapy prior to resection of a     pancreatic head malignancy. The patients will be randomized into two groups; surgery first     (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall     survival after resection   "
27198|NCT02929940|"     Alpha1-antitrypsin deficiency (AATD) is the third most common genetic disorder leading to     death worldwide. Apart from lung disease, AATD also leads to liver involvement in up to 50%     of patients. Hence, liver involvement is the second most common cause of morbidity and     mortality in AATD patients. But the natural history of disease in adults is not well     understood and specific therapies are still in the phase of preclinical studies. Despite     these facts and the therapeutic and preventative potential, the AATD-related liver disease is     still largely being neglected by both the patients and the healthcare professionals.      To improve the hepatologic care of patients with AATD, the investigators initiated a     prospective multi-center study in Europe that systematically evaluates the liver function in     these patients and their relatives. The investigators cooperate with both patient     organizations as well as with lung centers specialized on AATD-related lung disease.   "
27199|NCT02929927|"     This study tries to collect clinical cases to compare the clinical effect of traditional root     canal disinfection, to photodynamic in root canal disinfection .And provide the reference for     clinical application and experience.   "
27200|NCT02929914|"     The aim of the proposed study is to assess the clinical effect of photodynamic therapy     (PDT)using LED on dentin with carious lesions in permanent teeth. Patients with molars     exhibiting deep carious lesions on the occlusal surface indicated for restorative treatment     will be randomly allocated to two groups: Group 1 -Control after incomplete caries     removal,indirect pulp treatment with calcium hydroxide(CH); Group 2 - PDT + CH after     incomplete caries removal,disinfect the residual dentin with PDT(LED + methylene),then     indirect pulp treatment with CH. Dentin samples will be removed before and after PDT for     microbiological analysis. The microbiological samples will be cultured in Brucella blood     agar, Mitis Salivarius-bacitracin agar and Rogosa Selective Lactobacillus agar. The teeth     will then be restored using resin with clinical and radiographic follow up at six, 12 and 24     months. The data will be submitted to descriptive statistics.   "
27201|NCT02929901|"     The purpose of this study is to investigate the effects of coffee main constituents (caffeine     and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and     fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients     with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group     1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus     placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo.     Supplementation will be daily and will supervise for 6 months.   "
27202|NCT02929888|"     Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater     pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute     coronary syndrome. However, evidence is lacked about the effects of achieving faster and     stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to     oral aspirin on prasugrel inhibited platelets. Recently, we demonstrated in healthy     volunteers that the administration of intravenous LA resulted in a significantly reduction of     platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. Loading dose     of LA achieves platelet inhibition faster, greater and with less variability than aspirin.     However, there are no data of this issue in patients with an ST-segment elevation myocardial     infarction (STEMI). The ECCLIPSE-STEMI trial will study the effect of LA versus aspirin in     platelet reactivity in patients with STEMI   "
27203|NCT02929875|"     In an experimental research, 100 nulliparous pregnant women who had referred to health care     centers in Kermanshah were randomly selected and after taking Written Informed Consent     letter, assigned into case and control groups. instruction based on TPB was provided just for     the case group. Afterwards, post-test was taken by both groups and the results were analyzed.   "
27204|NCT02929862|"     This is a Phase 1/2a study designed to evaluate the safety and tolerability of increased     repeated doses of LYC-55716 in subjects with locally advanced or metastatic solid tumors.   "
27205|NCT02929849|"     The purpose of this study is to determine whether an herb with known alpha-glucosidase     inhibitor properties (Salacia Chinensis, SC), affects postprandial appetite ratings and     glucose indices in overweight/obese individuals.   "
27206|NCT02929836|"     This randomized prospective study compared three ablation strategies in patients with     longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural     endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial     (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram     (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation,     and PVI+CFAE ablation.   "
27209|NCT02929589|"     This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing     oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open     unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid     (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal     fentanyl), which can be continued. The patients will not be allowed to continue any     over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing     medications, that were not prescribed by the investigators during this study. Patients not     receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill     will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the     investigators nor the research subjects will know if the subject is receiving a placebo     versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be     followed for 2 months after their surgery. The research aims to discover the appropriate     amount of opioid medication to prescribe to patients undergoing an elective open inguinal     hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination.     The investigators expect that the subjects who take ibuprofen will use less     oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute     to reducing the surplus opioids prescribed by physicians after surgery, which can lead to     opioid use disorders. This particular procedure is common in men, and the findings have the     potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who     undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.   "
27959|NCT02919774|"     The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad     Methionil, POMA) at selected doses on ketamine-stimulated glutamate release in prefrontal     cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).   "
27211|NCT02929563|"     This study tests the feasibility of a large study of stress ulcer prophylaxis in critically     ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to     require mechanical ventilation for more than 48 hours will be randomized to intravenous     pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical     ventilation.   "
27212|NCT02929550|"     Methods: All patients <75 years registered in the Swedish Secondary Prevention after Heart     Intensive care Admission registry (SEPHIA), will be followed-up within one year     post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for     recurrent cardiovascular disease (CVD) events and death will be used to estimate base case,     and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of     the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´     Collaboration findings.   "
27213|NCT02929537|"     With the comparative effectiveness research methods and hospital registration study approach,     the purpose of this study is to objectively record the methods, efficacy and its influencing     factors of COPD commonly used treatment methods/programs (Western medicine, Traditional     Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of     application characteristics for the different programs, and provide the basis for its     revision and promotion. It is a first registration study for COPD in China.   "
27214|NCT02929524|"     Randomized clinical trial, controlled, double-blind, parallel two-arm.   "
27215|NCT02929511|"     In this study, the researchers will investigate the effect of single-file reciprocating     versus single-file rotational file systems on the postoperative pain in adult patients who     have necrotic pulp and apical periodontitis. The participants will be assigned by chance to     separate groups that compare 2 different treatments, reciprocating single-file system     (Reciproc Blue) and rotational single-file system (OneShape).   "
27216|NCT02929498|"     This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of     GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study     consisted of 2 parts. The objective of Part 1 is to determine the recommended phase 2 dose     (RP2D) of GSK2879552 administered alone and in combination with azacitidine in adult subjects     with high risk MDS previously treated with HMA. The objective of Part 2 is to evaluate     clinical activity after treatment with GSK2879552, alone or in combination with azacitidine,     in adult subjects with high risk MDS previously treated with HMA.   "
27217|NCT02929485|"     In this study, the investigators are looking at how people make decisions about     reward-related items, both monetary and food related after taking either the dopamine agonist     bromocriptine or the COMT inhibitor tolcapone, in healthy control subjects. Subjects will     fill self-report questionnaires and undergo an MRI scan.   "
27218|NCT02929472|"     The aim of this study was: to evaluate the effectiveness of a multicomponent pilot     intervention in improving physical fitness (PF) and metabolic risk markers in children and     adolescents; and examine if possible changes in PF are associated with metabolic risk markers     in children and adolescents exposed to intervention. For such, a multicomponent pilot     intervention was performed, consisting of sessions of physical exercise and nutrition     education.The study included 35 children and adolescents (ages 7-13) divided into two groups:     a intervention group (INT, n = 17) and a control one (CONT, n = 18). The sample underwent two     moments of data collection (T0 and T1). The 1-hour exercise sessions were held based on an     intensity above 65% of maximum HR. To assess the metabolic risk markers, analyzes of total     cholesterol, HDL-C fraction, LDL-c fraction, triglycerides, blood glucose, insulin, aspartate     aminotransferase (AST) and alanine aminotransferase (ALT) were conducted in T0 and T1.     Physical activity (PA) was assessed by accelerometry (Actigraph, GT3-X model, Florida) for 10     consecutive days. The health related PF components were evaluated throw different tests 20m     Shuttle-run Test; handgrip dynamometry (TKK 5101 tightening D; Tokyo Japan); standing feet     jump Test; Abdominal Test; trunk extension test; and body mass index (BMI) was calculated.     Motor fitness was assessed by coordinations Test für Kinder - KTK. To assess food     consumption, a 24-hour recall was held. For statistical analysis, the t-Student test and     General Linear Model (GLM) - ANCOVA for repeated measures test with post-hoc Bonferroni (p     <0.05) were performed. Multilinear regressions were done to analyse associations between     measured outcomes.   "
27232|NCT02929290|"     The main objective of this study is to evaluate the safety, tolerability, efficacy and     pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC.Biomarkers     related to the efficacy of BPI-9016M will be investigated.   "
27219|NCT02929459|"     The purpose of this trial is to investigate comprehensively the effect of riboflavin     supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota     in faeces of healthy volunteers. Additionally it will be assessed whether riboflavin     supplementation affects the abundance of potentially pathogenic bacteria such as adherent     invasive E. coli (AIEC). Finally, the effect of riboflavin supplementation on the production     of Short Chain Fatty Acids, the release of gut hormones and potential changes in glucose     homeostasis and appetite perception will be assessed.   "
27220|NCT02929446|"     Advances in surgical technique have led to a more complex surgery on patients with more     serious comorbidities and the risk of postoperative pulmonary complications (PPC) such as     pneumonia, and respiratory insufficiency, is considerable . The isolated effect of     mobilization immediately after surgery has previously not been studied. The aim of the study     is to evaluate the effects of immediate mobilization (within 2 hours) after abdominal     surgery.      Methods      A randomized controlled trial will be conducted . A total of 200 Swedish-speaking, adult     patients (≥18 years) planned for elective open abdominal surgery with surgery time exceeding     2 hours are eligible for consecutive enrollment in the study. Patients who cannot walk     independently will be excluded. Procedure: Patients will be randomized to either:        1. Mobilization within 2 hours after surgery - sitting 1-3 hours in a chair interspaced by          1 hour bedrest during the day of surgery or to        2. Mobilization within 2 hours after surgery - sitting 1-3 hours in a chair interspaced by          1 hour bedrest during the day of surgery + breathing exercises with PEP or to        3. No mobilization - that is laying or sitting in bed with a maximum of 30° elevation of          the head rest. No mobilization out of the bed until after 4 hours.      Outcome assessment The primary outcome is occurrence of respiratory insufficiency defined as     arterial oxygen pressure (PaO2) <8 kilo pascal (kPa) measured via arterial blood gas sample,     or peripheral oxygen saturation (SpO2) <90%, measured peripherally with a pulse oximeter.     Secondary outcomes are changes in arterial carbon dioxide pressure (PaO2), arterial oxygen     pressure/fraction inspired oxygen (PaO2/FiO2) (arterial blood gas sample) over time and     between groups; lung function assessed as inspiratory vital capacity (IVC), forced vital     capacity (FVC), forced expiratory flow in the one second (FEV1) and peak expiratory flow     (PEF) by a micro spirometer; number of patients with respiratory insufficiency, defined as     SpO2 <90%, or PaO2 <8kPa and/or PaCO2 ≥6.5 kPa measured without oxygen supply ; postoperative     pneumonia and total length of stay at the wards and at the hospital.      Clinical significance If a fairly simple and cheap intervention, such as mobilization     immediately after open abdominal surgery, can lead to less postoperative complications,     shortened stay at hospital in total, it should be included as a routine in postoperative     care.   "
27221|NCT02929433|"     The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support     base, designed to measure the amount of muscle work performed during exercise and the     resistance to pedaling. The cycloergometer has been already employed in many fields of     medicine.      However, up to date, a little use of cycloergometer in the management of chronic joint     diseases has been documented and scientific studies have not clarified if cycloergometer is     effective in these diseases and, particularly, in Rotator Cuff Tear patients.   "
27222|NCT02929420|"     The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in     the treatment of cyclomastopathy.   "
27223|NCT02929407|"     The purpose of this trial is to investigate safety, tolerability, pharmacodynamics, and     pharmacokinetics after intravenous administration of FE 204205 in patients with cirrhotic     portal hypertension.   "
27224|NCT02929394|"     Maintenance therapy with trabectedin versus observation after first line treatment with     doxorubicin of patients with advanced or metastatic soft tissue sarcoma.      This is a prospective, multicenter, randomized, open label Phase III trial investigating     whether a maintenance treatment with trabectedin, as compared to the observational approach,     can prolong progression-free survival in patients with advanced, inoperable and/or metastatic     STS after response or stabilisation during first line treatment with doxorubicin.   "
27225|NCT02929381|"     The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical     practice.      The important elements of this evaluation are:        -  Evaluation of the character of neoplastic lesions in the colon based on different          imaging techniques        -  Verification of the endoscopic image with histopathologic descriptions        -  Establishing the type of the lesion on the basis of Kudo and NICE classifications        -  Comparison of the result of histopathological examination with the macroscopic type of          the lesion        -  Determination of the most advanced lesions (MAL)        -  Comparison of the cecal intubation time        -  Evaluation of the type of anesthesia used during colonoscopy        -  Subjective assessment of the severity of pain according to VAS (visual analogue scale)        -  Comparison of the accuracy of the location of lesions on the basis of endoscopic          navigation        -  Comparison of the total examination time        -  Comparison of adenoma detection rate   "
27226|NCT02929368|"     Peripherally inserted central catheters, or PICC lines, has now been successfully in use for     many years, especially in the chemotherapeutic treatment of oncologic patients or in     parenertal nutrition. The implantation of PICC lines is mostly performed under x-ray     (fluoroscopy). The aim of the clinical study is to assess the safety and the efficacy of the     SHERLOCK-Systems eliminating the confirmatory chest x-ray exposure. Additionally, the     SHERLOCK-System immediately confirms the PICC tip position even at the bedside of the     patient, thus, saving costs and time.   "
27227|NCT02929355|"     Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an     increased risk of vascular events. Investigators assessed prospectively by arterial duplex     ultrasonography the progression of carotid atherosclerosis in a cohort of people with     diabetes to assess the importance of progression and to analyze the impact of this     progression on vascular events. The main hypothesis is that people with carotid     atherosclerosis progression are at higher risk of vascular events than those without any     progression.   "
27228|NCT02929342|"     The purpose of this study is to better define the absorption and elimination pathways, and     circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in     healthy CYP2D6 genotyped male subject.   "
27229|NCT02929329|"     The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when     added to standard of care is well tolerated and superior to placebo in reducing the risk of     cardiovascular death or heart failure events in subjects with chronic HFrEF.   "
27230|NCT02929316|"     Celiac disease (CD) is characterized as an autoimmune disorder whereby gluten (a protein     found in wheat, barley, rye, malt) induces an immunological response in genetically     susceptible individuals. The prevalence of CD has been estimated to affect 0.5-1% of the     population worldwide. Long term sequelae are numerous and include risk of lymphoma,     malabsorption leading to weight loss, anemia, multiple vitamin deficiencies,     osteoporosis/osteopenia, secondary autoimmunity, etc. (1)   "
27231|NCT02929303|"     This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in     infants and children with parenteral nutrition associated liver disease (PNALD) to decrease     elevated liver enzymes and direct bilirubin.      This study aims to describe the response of PNALD after use of Omegaven by normalization of     serum levels of liver enzymes and bilirubin.   "
27233|NCT02929277|"     PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across     Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133     children (farmers in about half of the children) to study the origins of asthma and atopy and     to develop potential preventive strategies.      Previous results show a protective effect of farm exposure on allergic risk by livestock     contacts and microbial exposures and by raw cow milk consumption in early age.      PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to     characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis)     and to explain how early age exposures and particularly milk products consumption contribute     in the process of allergic illness in childhood. A focus on the characterization of the     protective biologically active components in raw milk and identification of immunological     mechanisms are involved.   "
27234|NCT02929264|"     An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental     hyperalgesia and its neural correlates.   "
27254|NCT02929004|"     These last years, it has been proven that the solicitation of a muscle using vibration may     lead to positive effects on the neuromuscular function. Thus, the aim of the current study is     to assess if the addition of local vibration training sessions on the quadriceps muscle to     the classic readaptation program (i.e. physiotherapist sessions) may allow a better     recuperation 2 months after the surgery and the reconstruction of the anterior cruciate     ligament.      The aim of the vibration training proposed in the current study is to allow a better     recuperation 2 months after the anterior cruciate ligament reconstruction when compared with     conventional physiotherapy alone.   "
28161|NCT02917135|"     This is a post-market, observational, retrospective multi-center Registry designed to gather     information on the performance of the Angel® Catheter in general clinical practice.   "
27235|NCT02929251|"     RUBI, is the first prospective randomized, head to head study, comparing Adalimumab to either     anakinra, or tocilizumab in refractory Non Infectious Uveitis (NIU). There is no firm     evidence or randomized controlled trials directly addressing the best biologic agent in     severe and refractory NIU. NIU can cause devastating visual loss and up to 20% of legal     blindness. Corticosteroids and immunosuppressants failed to demonstrate sustainable remission     over 70 % of refractory/relapsing severe uveitis. The incidence of blindness in NIU has been     dramatically reduced in the recent years with the use of biologics, raising the question of     whether these compounds should be used earlier in the treatment of severe non infectious     uveitis. Contrasting with immunosuppressors, biotherapies act rapidly and are highly     effective in steroid's sparing thus preventing occurrence of cataract and/or glaucoma.      Despite a strong rationale, these compounds are not yet approved in uveitis, which guarantees     the innovative nature of this study that aims selecting or dropping any arm when evidence of     efficacy already exists.   "
27236|NCT02929238|"     You are being asked to participate in this study because you have a complex wound that     requires treatment with negative pressure wound therapy (NPWT). NPWT is a therapeutic     technique which involves the placement of a wound vacuum at the site of the wound. The wound     vacuum delivers a negative pressure at the wound site through a dressing. Any fluid collected     during this process is collected through a foam (sponge) underneath the dressing. This     therapy helps to draw the edges of the wound together, while removing infectious material, to     help promote healthy tissue growth and speed up wound healing. The purpose of this study is     to determine if placing polypropylene suture (a material normally used to close wounds)     between the wound and the NPWT foam would decrease pain upon removal of the sponge while     allowing adequate healing of the wound.   "
27237|NCT02929225|"     Intestinal microbiota has recently emerged as an important player in the progression and     complications of chronic kidney disease(CKD). And drug therapy which selects the gut as a     target has raised lots of concern. It has been reported that the composition of intestinal     flora has changed in uremic patients. Specifically, imbalanced ecosystem has higher number of     pathogens such as Clostridia, Enterobacteria,and lower number of beneficial microbes such as     Lactobacilli and Bifidobacteria. This modification of intestinal flora can strongly increase     transformation of amino acids into Uremic Retention solutes, e.g., indoxyl-sulfate (IS),     p-cresyl sulfate (PCS), which are so called gut-derived uremic toxins. The dysbiosis also     contributes to an increase in intestinal permeability by disrupting the colonic epithelial     tight junction,which may subsequently lead to translocation of endotoxin and bacteria into     the host's internal environment,resulting in systemic micro-inflammation.Also all of these     can promote the progression of renal failure and the incidence of cardiovascular     complications,renal osteodystrophy and anemia.Probiotics is defined by the World Health     Organization as 'live microorganisms that, when administered in adequate amounts, confer a     health benefit on the host'. Probiotics are being increasingly used for various pathologic     conditions.It is said that probiotics have a therapeutic role in maintaining a metabolically     balanced gastrointestinal tract (GIT).And in our previous study,the investigators found that     in uremic rats,lactobacillus acidophilus can relieve bacterial translocation and decrease the     level of inflammatory markers.So our study is mainly designed to investigate whether     probiotics can modulate the balance of intestinal ecosystem, prevent the bacterial     translocation from gut and alleviate the systemic inflammation in hemodialysis(HD) patients.   "
27238|NCT02929212|"     The purpose of this study is to determine the effect of meal size and texture on the levels     of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake     change after bariatric surgery and patients often eat multiple small low-calorie meals, a     pattern that may affect blood glucose as well as incretin levels. Whether the release of     GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in     'real life' setting of multiple small meals diet is unclear.   "
27239|NCT02929199|"     The aim of this study compare soft tissue reaction (bleeding, gingival color and texture),     bacteria type and count in the gingival sulcus around the restoration margin and sulcus depth     of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless its     popularity in the dental field.   "
27240|NCT02929186|"     This is a randomized controlled pilot study aimed at testing different outreach strategies     (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed     home fecal immunohistochemical testing (FIT).   "
27241|NCT02929173|"     The aim of this study is to compare the patient satisfaction and clinical assessment (shade     matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP)     restoration versus E-max restoration compared to contralateral tooth in anterior zone.      Regardless E-max popularity in the dental field.   "
27242|NCT02929160|"     Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with     retrograde ureteric stenting for emergency renal decompression in cases of obstruction and     sepsis associated with ureteric calculi.   "
27251|NCT02929043|"     Up to date, devices capable of delivering controlled, calibrated, non-contact cold air     stimuli in a MR environment are unavailable for quantitative sensory testing. This project     therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold     air stimulation device that produces air puffs in a broad flow and cold temperature range. By     means of this device, detailed psychophysically testing and subsequent brain scanning of     dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH     mechanisms.   "
27252|NCT02929030|"     The study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary     stent system (NANO plus) in patients with coronary artery disease . The primary endpoint is     target lesion failure, a composite endpoint of cardiac death, target vessel related     myocardial infarction and clinically-driven target lesion revascularization at 1 year     follow-up.   "
27243|NCT02929147|"     An optimal analgesic therapy is very important for postoperative recovery. In recent years,     several studies showed that the prevalence of the moderate to severe pain after craniotomy     ranged from 69 to 87% of patients. In a previous study, the investigators showed that the use     of morphine based patient controlled analgesia prevented moderate to severe postoperative     pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as     sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance     for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid     related side effects in the intensive care unit for 24 hours following surgery in the     previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates     respiratory and hemodynamic parameters noninvasively. In the present study the investigators     will use different doses of morphine based PCA and the IPI system to determine more effective     and safer morphine dose for postoperative analgesia following supratentorial craniotomy.   "
27244|NCT02929134|"     Current lymphedema management protocols are based on the use of simple measures of hygiene     (regular washing with soap and water, skin and nail care), use of topical antibiotics or     antifungal agents, exercise and footwear. This is considered the standard of care in most     endemic countries in the absence of any structured treatment programs. Previous controlled     clinical trials and extensive field experience have shown the benefit of these measures in     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the     progression of lymphedema.      In the present study, the progression of lymphedema in a group of patients who receive a     six-week course of doxycycline will be compared with that of a group who receives doxycycline     look-alike placebo tablets. However, both groups will be enrolled into a standardized     regimen of hygiene described above. Thus, patients enrolled in the placebo group also     will receive the current standard of care, and the placebo used in the study will help to     identify the benefits of doxycycline on a background of simple hygiene measures. The regimens     will be explained to all participants who will be trained to use established standardized     methods of hygiene and be effectively applying it prior to the initiation of the drug     treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common,     generic SOP with handouts that describes methods and the training schedule will be used so     that similar methods are employed across all sites.   "
27245|NCT02929121|"     Current lymphedema management protocols are based on the use of simple measures of hygiene     (regular washing with soap and water, skin and nail care), use of topical antibiotics or     antifungal agents, exercise and footwear. This is considered the standard of care in most     endemic countries in the absence of any structured treatment programs. Previous controlled     clinical trials and extensive field experience have shown the benefit of these measures in     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the     progression of lymphedema.      In the present study, the progression of lymphedema in a group of patients who receive a     six-week course of doxycycline will be compared with that of a group who receives doxycycline     look-alike placebo tablets. However, both groups will be enrolled into a standardized     regimen of hygiene described above. Thus, patients enrolled in the placebo group also     will receive the current standard of care, and the placebo used in the study will help to     identify the benefits of doxycycline on a background of simple hygiene measures. The regimens     will be explained to all participants who will be trained to use established standardized     methods of hygiene and be effectively applying it prior to the initiation of the drug     treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common,     generic SOP with handouts that describes methods and the training schedule will be used so     that similar methods are employed across all sites.   "
27246|NCT02929108|"     The project will test the effect of educating and supporting caregivers of hospice cancer     patients on their active participation in shared decision making in the plan of care for     their patients.   "
27247|NCT02929095|"     Percutaneous trans-arterial angioplasty(PTA) is one of the peripheral arterial occlusive     disease(PAOD) treatment. During and after PTA, ischemia-reperfusion pain is induced so proper     analgesia is important. ischemia-reperfusion injury is due to reactive oxygen species.     Dexmedetomidine has analgesic, sedative and anti oxidant effect. So the investigators     research the patient's satisfaction that are given the dexmedetomidine during PTA procedure.   "
27248|NCT02929082|"     FORCE project aims to measure actives forces of malignant tumor by magnetic resonance force     (FRM). Two main forces are considered as key indicators of therapeutic response and     metastatic potential: interstitial force and traction force at the interface cell/tumor.     Biomarkers of these forces will be developped using direct images of magnetic resonance force     (FRM). Efficiency of these non-invasive biomarkers will be evaluated through their capacity     to predict tumoral environment invasion, notably micro-vascular invasion, and therapeutical     results in Hepatocellular Cancer (HCC).      Principal criteria will be        1. micro-vascular invasion assessed by pathological examination of surgical pieces (gold          standard).        2. interstitial force and traction force at the cell/tumor interface assessed by FRM.      Population of patients will be divided in three groups. A first group will be constituted of     20 volunteer patients coming for abdominal MRI with no known hepatic disease, in order to     determine the feasibility of FRM. A second group will be constituted of 60 patients with     resectable HCC eligible for surgery. This group will enable to evaluate the tumoral     environment invasion. Third group will be constituted of 50 patients with HCC eligible for     transplant with transcatheter arterial chemoembolization (TACE) treatment as pending     treatment before transplant. This groups will enable to evaluate the efficiency of TACE     through the necrosis percentage in treated HCC.      Inclusion of patients will occur during 24 months for a total study duration of 36 months.      All patients will have MRI as usual care. FRM is performed during MRI with the use of a     specific medical device and therefore corresponds to an additional procedure of the research.      Moreover, patients in group 2 and 3 will be asked to participate to an ancillary study     consisting in circulating tumoral cells (CTC) measurement. If they accept, a blood sample     will be collected just before the MRI in order to evaluate the correlation between CTC and     micro-vascular invasion.   "
27249|NCT02929069|"     The intent of the proposed randomized controlled trial is to test the efficacy of a     principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that     addresses the pathways through which minority stress compromises young gay and bisexual men's     (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual     (e.g., condomless anal sex) health problems.   "
27250|NCT02929056|"     The purpose of this study is to evaluate and compare healing characteristics, reduction in     the size of the wound and to measure complete healing of the wound following the application     of a biologic product dressing instead of the alginate dressing along with standard     debridement and compression therapy versus the standard of care treatment for VLUs. The     biologic product that will be used in this study is called AmnioExCel™.   "
27267|NCT02928835|"     To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a     total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were     randomly assigned in two groups: control group and Dynasplint group.   "
27253|NCT02929017|"     Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to     receive this intervention or usual care. The intervention will include information about the     disease, self-management strategies, and introduction to advanced care planning in a format     with enhanced content available across multiple domains (face-to-face, printed material,     digital (tablet) delivered by an interventionist. The usual care group will be provided with     routine printed patient education.      At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor     quality of life, and inadequate preparedness for end-of-life care planning. The proposed     study will measure feasibility, acceptability, and impact of a Supportive Care intervention.   "
27275|NCT02928731|"     The aim of this study is to explore the impact of cancer and therapy-related symptoms on     Mainland Chinese children's physical and psychological well-being.   "
27255|NCT02928991|"     This is a pilot study to determine whether fludarabine-based reduced intensity conditioning     (RIC) regimens facilitate successful donor engraftment of patients with acquired aplastic     anemia (AA) and Inherited bone marrow failure (iBMF) syndromes undergoing Matched related     donor bone marrow transplant (MRD-BMT).   "
27256|NCT02928978|"     This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the     study participants will receive ruxolitinib for approximately 15 days, and the other half     will receive a placebo (sugar pill) for approximately 15 days. Once study participants have     completed their ruxolitinib or placebo, participants will undergo surgery to remove the     premalignant breast tissue.   "
27257|NCT02928965|"     The purpose of this study is to investigate if minocycline limits the development of negative     symptoms in early psychosis and to test via what mechanism of action this change occurs.   "
27258|NCT02928952|"     The purpose of this study is to see if adding Mindfulness training to diabetes education     reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve     diabetes outcomes (such as hemoglobin A1c).   "
27259|NCT02928939|"     Clinical practice guidelines do not take into account multimorbidity and various potential     therapeutic conflicts. Identifying and quantifying therapeutic conflicts is crucial in     multimorbid patients having more than two acute or chronic diseases. Guidance should be     available for frequent encountered situations, e.g. gastrointestinal bleeding or exacerbation     of diabetes mellitus.   "
27260|NCT02928926|"     Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally     maintained at a constant level, over a relatively wide blood pressure range. It can be     assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound     probes over both sides of the head to measure changes in blood flow in one of the main brain     arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure     dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following     moderate to severe stroke, acting as a key role in the development of secondary brain damage     related to brain swelling and further damage related to low blood flow. The administration of     clotbusting therapy (thrombolysis), one of the main approved treatments of acute ischaemic     stroke (AIS), results in recanalization of the blocked artery in over approximately 50%     patients. However, due to its clot dissolving property, it may increase the risk of bleeding     in the body, especially in the brain, leading to greater disability or even death. To date,     there has been very little information regarding the natural history and prognostic     significance of impaired Cerebral Autoregulation during and following reperfusion, especially     those who receive thrombolysis. This research will use the noninvasive technique of Trans     Cranial Doppler (TCD) to see how blood flow changes in AIS patient at the initiation and     completion of thrombolysis, and during acute, subacute and chronic phase post stroke onset,     compared with those AIS patient who did not receive thrombolysis. This study will provide     important data regarding perithrombolysis blood pressure management, an important and common     clinical dilemma   "
27261|NCT02928913|"     To investigate associations between sedentary and active behaviour with bone health and     functional ability, and to associate mechanical loading at the lumbar spine and hip in     sedentary and active individuals with bone mineral density.   "
27262|NCT02928900|"     The goal of this study is to develop and evaluate a clinical training intervention utilizing     standardized patient actors to improve communication and interpersonal skills of health care     workers who serve HIV-infected adolescents and youth in Kenya, resulting in increased     engagement in HIV care. The effect of the intervention on retention in care will be evaluated     in a stepped-wedge randomized controlled trial at 24 HIV care and treatment facilities.   "
27263|NCT02928887|"     The goal of this study is to determine whether or not exposure to blue spectrum light reduces     acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass.     Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright     (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour     photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate     postoperative period.   "
27264|NCT02928874|"     Using an integrated approach, this study examines multiple eating traits concurrently under     states of hunger and satiety. It examines the impact of short-term appetite and intake     regulation on longer-term energy intake control and weight development in a cohort of     ethnically diverse normal-weight and obese boys and girls with different familial     predispositions to obesity.   "
27265|NCT02928861|"     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of     diffuse large B-cell lymphoma can predict disease progression   "
27266|NCT02928848|"     In the present sham-controlled study, the investigators examine whether tDCS could be used to     enhance language abilities (e.g., picture naming) in individuals with PPA variants primarily     characterized by difficulties with speech production (non-fluent and logopenic).   "
27273|NCT02928757|"     There are ~6,200 children in Ontario with special and complex healthcare needs requiring     multiple services from many different doctors and other healthcare providers. These children     are at a high risk of missed, duplicated or inappropriate care, and extraordinary financial     burden and stress on families. While small in number (<1% of Ontario kids), these children     use 1/3 of all child healthcare resources, and are known to desperately need coordinated care     to optimize their health. Complex Care Kids Ontario (CCKO) brings together researchers,     children and families, and healthcare providers from across Ontario to develop, implement and     evaluate an evidence-based and coordinated model of care for every child with medical     complexity in Ontario.   "
27274|NCT02928744|"     Limitation of expiratory flows is considered as the main determiner of dynamic distension and     dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal     resistances should allow to better appreciate the functional impact.      This study should also allow to specify the best parameters in respiratory functional     explorations useful for the follow-up in COPD and to specify the relevance of functional     indications other than the forced expiration volume at 1 second (FEV1) or the functional     residual capacity (FRC) to estimate in a more relevant way the clinical improve with the     increase of the therapeutic load (increase of posology, association of two bronchodilatators,     addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from     a persistent dyspnoea insufficiently relieved.   "
27276|NCT02928718|"     Pancreatitis remains the most common complication of ERCP, with the reported incidence     ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may     develop severe pancreatitis, that means additional morbidity and risk for death. ERCP,     despite the development of new diagnostic tools, remains a widely used procedure, so     post-ERCP pancreatitis is a problem with significant impact. Several studies and     meta-analyses helped us to recognize special factors that put an individual in high risk for     the development of post-ERCP pancreatitis. Among these factors special interest presents the     history of post-ERCP pancreatitis as an independent risk factor for a new episode of     post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed     susceptibility in this particular complication. The aim of the present study is to     investigate the possible genetic variation associated with post-ERCP pancreatitis using whole     genome sequencing.   "
27277|NCT02928705|"     The purpose of this retrospective study is to analyze quality and adverse events of analgesia     by telemedically supported paramedics in comparison to conventional treatment by on-scene     emergency medical service (EMS) physicians in the EMS of the city of Aachen, Germany.   "
27278|NCT02928692|"     Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged     patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of     POCD is not clear yet and no effective therapy method was proved. According to previous     study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a     tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood     brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven     in many experimental animal models such as Alzheimer's disease, Huntington's disease and     Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would     attenuate the incidence of POCD and POD in the aged patients.   "
27279|NCT02928679|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In     the parent trial, patients will be subjected to an 8-week diet intervention phase including a     low-calorie diet and dietetic counseling, after which patients will be randomised to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.      This substudy aims to investigate the impact of, and subsequent change of, joint     inflammation, articular cartilage composition, overall knee morphology, and clinical     symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide     3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.   "
27280|NCT02928666|"     Introduction: in the course of the research, the investigators will develop a     decision-support system (comorbidity-DSS) consisting (1) a knowledge base (KB) consisting of     (a) computer-interpretable clinical guidelines for type 2 diabetes and 2 other diseases from:     obstructive pulmonary disease, osteoporosis, hypertension, and osteoarthritis; and (b) an     ontology of relevant general medical knowledge that could complement (a) in order to propose     non conflicting treatment options not mentioned in the clinical practice guidelines; and (2)     an algorithm that matches the KB with a patient's data set to identify the guidelines-based     recommendations applicable for the patient and their interactions and which proposes ways to     mitigate conflicting interactions (e.g., suggesting to select intervention A.2 (instead of     A.1) from guideline A and intervention B.3 (instead of B.1) from guideline B together with an     action B' mentioned in the general medical knowledge, because these interventions are not     conflicting yet A.3 fulfills the same goals as intervention A.1 and intervention B.3 + B'     together fulfill the same goal as B.1).      Research purpose: Assessing the correctness and completeness of detection of     recommendation-interaction and generation of conflict-free recommendations by a     comorbidity-DSS      Research question: How will the usage of the comorbidity-DSS affect the completeness and     correctness of clinicians regarding (a) detection of interactions between recommendations     originating from different clinical guidelines applicable for patients with comorbidities and     (b) identification of interventions that fulfill the guidelines' goals and are not     conflicting.   "
27281|NCT02928653|"     The aim of this study will be to compare the effects of daily consumption of aspartame,     rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a     standardized protocol. The investigators hypothesize that individual low calorie sweeteners     (consumed in a beverage) differ from each other in promoting weight loss and decreased fat     mass (without energy restriction or dietary guidance) based on their chemical structure.   "
27282|NCT02928640|"     The purpose of the study is to collect information on prostrate biopsy tissue for use in     developing a method determining the difference in normal and cancerous prostrate tissue using     the ClariCore System.   "
27283|NCT02928627|"     Hepatocellular carcinoma (HCC) is the most frequent primary tumour of the liver and is the     third cause of cancer-related mortality worldwide. Depending on the stage of the disease, the     treatment options are surgery, liver transplantation, chemotherapy or radiotherapy.      Recently, scientific research has focused on small molecules called microRNAs which are     produced by human cells and can be released in the blood. They have a role in cell     proliferation and are found to be dysregulated in different types of cancer.      It has been shown that microRNAs have a role in the development of HCC but it is unknown if     these molecules can be used as markers for diagnosis and survival in HCC.      In particular, microRNAs miR-221 and miR-222 are dysregulated in the tumoral tissues in about     80% of patients with HCC. This can be assessed on tissues from liver biopsies or surgical     specimens, both invasive approaches. Only few studies showed the presence of microRNAs in the     blood of patients with HCC but it is unknown if there is a correlation between tumoral tissue     expression and circulating levels.      The aim of this study is to evaluate if these two microRNAs are expressed not only in the     tumoral tissues but also in the blood from cancer patients, and in different amounts compared     to circulating levels in healthy individuals. A correlation between tumoral tissue and blood     levels will also be evaluated.      Should this evaluation show a strong correlation and reliability of circulating microRNAs in     the diagnosis and follow up of HCC, future clinical trials targeting these microRNAs and     their related pathways might benefit from this being adopted as conventional practice instead     of the need of assessing tissue levels from liver biopsies.      The results of this pilot study will bring preliminary results as a first step for future     analysis on a larger cohort of patients.   "
27296|NCT02928445|"     This 6-month extension study will provide further information regarding the long-term safety     and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB)     who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.   "
27800|NCT02921867|"     The investigators hypothesise that simulation-based training will have initial educational     benefits and in coherence with the traditional apprenticeship model will heighten the     educational end-level: That training on the simulator before clinical education will prepare     the trainee for practice and thereby support more effective learning.   "
27284|NCT02928614|"     This is a substudy to a randomized trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In     the parent trial, patients will be subjected to an 8-week diet intervention phase including a     low-calorie diet and dietetic counseling, after which they will be randomized to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.      This substudy aims to investigate the impact of, and subsequent change of biomarkers in obese     patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or     Liraglutide 3 mg placebo treatment between weeks 0-52.   "
27285|NCT02928601|"     This study evaluates the effect of prophylactic ondansetron on the incidence of spinal     hypotension and vasopressor consumption in caesarean section patients using norepinephrine     treatment. Half of participants receive ondansetron before spinal anesthesia while the other     half receive saline.   "
27286|NCT02928575|"     The purpose of this study is to determine whether a combination of Sunitinib, Temozolomide     and Radiation Therapy would be effective in the treatment of newly diagnosed Glioblastoma     patients harboring tumors with unmethylated MGMT promoter.   "
27287|NCT02928562|"     Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative     pain and swelling, protection of the healing graft, restoration of full range of motion     symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee,     hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional     activities that are required for return to the normal daily life. The effects of concomitant     injuries and surgical procedures must also be considered in planning an individualized     rehabilitation program. However, it is still unclear regarding the optimal exercise     prescription after TKA. In the current study, the investigators plan to develop an exercise     protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density     assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and     resistant training exercise for first, second and third year, respectively. Cyclic exercise     is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the     exercise can be quantitatively determined. Aerobic exercise is privileged by the     cardiopulmonary endurance improvement, along with muscle strengthening in the associated     muscle groups. Resistance exercise is specified for the indicated muscle groups, especially     knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients.     The investigators hypothesis that using this cyclic exercise process can improve the body     composition, muscle strength, bone mass density, level of oxidative damage indicators, gait     performance, quality of life, knee joint range of motion, function of cardiopulmonary and     fitness. This project will establish the scientific basis for rehabilitation protocol     involving knee surgery.   "
27288|NCT02928549|"     The purpose of this study is to explore the experiences of Black women who receive care for     ovarian cancer at Memorial Sloan Kettering Cancer Center, or MSK for short. The study     consists of interviews with Black women who recently obtained some part of their ovarian     cancer care at MSK.   "
27289|NCT02928536|"     Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a     European cross-sectional study, aiming at i) estimating prevalence and investigating     determinants of smoking, e-cigarette use and exposure to SHS and to e-cigarette aerosol; ii)     analyzing the attitudes, perceptions and behaviours of the adult European population towards     policies to limit SHS exposure; iii) comparing selected smoking-related data between TackSHS     and a previously conducted pan-European survey; iv) assessing mortality and morbidity from     selected respiratory and cardiovascular diseases attributable to SHS exposure among adults     and children in Europe; v) quantifying the economic burden associated to the exposure to SHS     and e-cigarette aerosol in Europe. Overall, approximately 12,000 individuals aged 15 years or     over will be enrolled in 12 different European countries (BG, DE, ES, FR, GR, IE, IT, LV, PL,     PT, RO, UK). Surveys will be representative of the country-specific population in terms of     sex, age, and socio-economic characteristics.   "
27290|NCT02928523|"     The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute     myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order     to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced     multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to     the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm     multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients     receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum     antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at     the time of admission and AML diagnosis, patients will be requested to donate stools that     will be comprehensively screened, and if deemed appropriate according to protocol criteria,     conditioned and stored frozen until future processing and transplantation after aplasia     completion.   "
27362|NCT02927587|"     Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious     sedation in flexible bronchoscopy (FB) .However, the target setting of effect-site     concentration (Cet) of propofol is still unclear in the elderly population .The aim of this     study was to compare two induction Cet of propofol in elderly patients undergoing flexible     bronchoscopy.   "
27294|NCT02928471|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In     the parent trial, patients will be subjected to an 8-week diet intervention phase including a     low-calorie diet and dietetic counseling, after which. Patients will be randomised to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.      This substudy aims to investigate any changes in MRI associated with the initial 8-week     weight loss intervention, and the value of CT scans in predicting the effect of weight loss.   "
27295|NCT02928458|"     This research study is for patients with adhesive small bowel obstruction (ASBO). ASBO is a     condition in which the small intestine gets blocked due to scars called adhesions. To see the     blockage, a contrast agent is given and an x-ray is taken of the belly (abdomen). MD     Gastroview and omnipaque are two contrast agents that may be given as part of your normal     care for ASBO. This study hopes to see if one is better than the other.   "
27297|NCT02928432|"     Abiraterone acetate (AA) has shown a favourable impact in overall survival, administered with     prednisone to decrease the adverse event related to CYP171A suppression.      Our hypothesis is that the change of prednisone to dexamethasone in CRPC patients that     progress biochemically to AA + prednisone can improve the number and the length of the     responses, and also improve tolerance to treatment, decreasing the adverse events associated     to a moderate dosage of steroids used chronically.   "
27298|NCT02928419|"     Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by     inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the     main therapeutic option in most patients. Quality of life is deteriorated mostly by anemia     and by limitations due to dependence on transfusions, thrombocytopenia, and neutropenia. The     only treatment available for severe thrombocytopenia consists of PLT transfusions, mainly in     the presence of bleeding.      In patients with low and intermediate-1 risk MDS with an isolated deletion 5q cytogenetic     abnormality, red blood cell (RBC) transfusion-dependence is a prevalent condition. For these     latter patients reaching transfusion-dependence, lenalidomide, an immunomodulatory drug, has     been approved by FDA and EMA. It has been shown that the drug induces significant erythroid     (about 65%) and cytogenetic responses which have been associated with a survival benefit. In     patients with MDS with del5q and serum erythropoietin levels > 500 miU/L, lenalidomide dosing     of 10 mg/day for 21 days every 28, rather than 5 mg dosing, induces higher rates of     transfusion-independence and cytogenetic responses with a trend to survival advantage. As a     consequence, the recommended starting dose of lenalidomide is 10 mg orally once daily on days     1-21 of repeated 28-day cycles. Lenalidomide treatment must not be started if the Absolute     Neutrophil Counts (ANC) < 0.5 Gi/L and/or PLT counts < 25 Gi/L.      For patients who are dosed initially at 10 mg and who experience thrombocytopenia < 25 Gi/L     (45-75%), it is recommended to interrupt lenalidomide treatment until PLT count returns to ≥     25 Gi/L on at least 2 occasions for ≥ 7 days or when the PLT count recovers to ≥ 50 Gi/L at     any time, to resume lenalidomide at 50% dose reduction.      Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. It has been     shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither     increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts.     Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the     formation of normal megakaryocytic colonies. These results provide the rationale for pursuing     further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.      Preliminary results of an ongoing randomized trial, EQoL-MDS, for the evaluation of efficacy,     safety of eltrombopag for thrombocytopenia of low and intermediate-1 IPSS risk MDS has shown     that eltrombopag is able to significantly raise PLT counts in about 65% of patients without     additional toxicity Furthermore, the combination of lenalidomide and eltrombopag resulted in     significant inhibitory effects on the growth of leukemic colonies in the majority of primary     MDS and AML samples. Most importantly, eltrombopag was able to reverse the     anti-megakaryopoietic effects of lenalidomide in primary MDS patient samples. These results     provide a preclinical rationale for the use of this combination in MDS and AML   "
27299|NCT02928406|"     This multicenter study will assess the safety of atezolizumab as second-line treatment for     participants with locally advanced or metastatic urothelial or non-urothelial cancer of the     urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor     biomarkers associated with atezolizumab.   "
27300|NCT02928393|"     This Phase 2a, randomized, double-blind, placebo-controlled, parallel group study will     evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with     severe motor impairment following an ischemic stroke.   "
27301|NCT02928380|"     In this clinical study, an experimental denture adhesive with a precision tip nozzle was     tested to evaluate the relative efficacy to reduce the ingress of food under the denture     compared to use of no adhesive or a standard marketed adhesive.   "
27302|NCT02928367|"     Community-acquired pneumonia (CAP) represents a major health care problem and mortality and     morbidity associated with severe pneumonia remain considerable, despite state of the art     care.      While the role of altered DNA methylation in cancer has been widely studied, knowledge of its     impact on antibacterial defense is highly limited. In addition, recent preclinical studies     showed that the gut and respiratory microbiota contributes to host defense against bacterial     pneumonia.      This study aims to explore a completely novel research area linking the extent of DNA     methylation in blood leukocyte (monocytes and neutrophils) and function of gut and     respiratory microbiota on the influence of innate immune responses to and host defense     against CAP   "
27303|NCT02928354|"     This study is an open label, randomized, three-way crossover study to assess the effect of     particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects     (males aged 18 to 55 years [inclusive]). The study will be performed at a single study     center.   "
27304|NCT02928341|"     The aim of the study is to evaluate the impact of a large-scale urban water supply     improvement intervention on cholera and other diarrhoeal diseases. The study uses a step     wedge cluster randomised controlled trial (SWcRCT) to measure the effect of the intervention     on cholera centre admission rates and confirmed cholera cases. A nested cohort study will     examine changes in water-related practices following the intervention.   "
27305|NCT02928328|"     The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human     subjects has never been investigated. However, as earlier studies suggest that activation of     peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these     findings can be translated into human subjects to determine if peripheral GABAA receptors are     a viable target for future analgesic drug development.   "
27306|NCT02928315|"     It is well known that magnesium sulfate has a membrane stabilizing effect , and broad     spectrum anti arrhythmic properties. In this trial, the investigators study its prophylactic     effect against atrial fibrillation in postoperative period of cardiac surgery.   "
27307|NCT02928302|"     Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about     15 million babies are born too soon every year, causing 1.1 million deaths, as well as short-     and long-term disability in countless survivors. Few prognostic tests are available to     predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a     good predictor of PTB.Different strategies have been adopted for prevention of PTB. The     evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix,     while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations     with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB,     nor in multiple gestations.      However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low     risk nor in high risk pregnancy Thus, we aim to assess the efficacy of a policy of TVU CL     screening in singleton pregnancy without prior spontaneous PTB   "
27308|NCT02928289|"     The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences     VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic     subjects with open-angle glaucoma.   "
27309|NCT02928276|"     RA is the most common inflammatory, persistent and progressive disease of the joints with     serious co-morbidities and huge health and socio-economic impact worldwide.   "
27310|NCT02928263|"     A retrospective study to evaluate healthcare cost and resource utilization for patients with     metastatic renal cell carcinoma who have been treated with IV or oral agents   "
27311|NCT02928250|"     Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by     Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and     innervated muscle) of vertebrates . Carnosine is claimed to decrease oxygen free-radical     mediated damage to cellular macromolecules either by chelating divalent cations or scavenging     hydroxy radicals with its imidazole moiety. Free-radical damage is not the only process to     affect the structure of proteins and nucleic acids.      To the best of our knowledge, no previous study assessed the role of carnosine in diabetes     associated complications in particular diabetic nephropathy and there is insufficient     evidence to recommend its supplementation in those patients. Therefore, this study was     undertaken to investigate the role of carnosine as an adjuvant therapy for diabetic     nephropathy in children and adolescents with type 1 diabetes and assess its relation to     microalbuminuria, tubulointerstitial damage marker, glycemic control and oxidative stress.   "
27312|NCT02928237|"     To evaluate the effect of transcranial direct current stimulation (tDCS) applied to the motor     cortex to reduce chronic abdominal visceral pain in a group of participants with     hepatocellular carcinoma   "
27313|NCT02928224|"     This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib +     cetuximab plus or minus binimetinib versus Investigator's choice of either     irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose     disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study     contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib +     binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.   "
27314|NCT02928211|"     This is an open-label study to evaluate Aftobetin-HCl and florescence detection as measured     by the Sapphire II device.      Performance of Part I of the study has been completed (15 subjects received a single     administration of Aftobetin HCL followed by Sapphire II measurements) and indicated that 3     administrations of Aftobetin-HCl are necessary. For Part II, a second group of up to 30     subjects (CN =10 and mild AD or MCI =20) will receive three Aftobetin HCL administrations. If     three administrations of Aftobetin HCL are optimal, up to an additional 30 MCI and 30 mild AD     subjects will be entered.      The purpose of the study as Part II is performed is to determine the ability of the Sapphire     II device to detect B-amyloid in the lens of the eye in subjects with Mild Cognitive     Impairment (MCI), and mild Alzheimer's Disease (AD) after three Aftobetin-HCl     administrations. Subjects with Normal Cognition (CN) will also be tested to further establish     that subjects who are highly unlikely to have B-amyloid deposits in the lens of the eye will     have close to baseline post ligand fluorescent uptake value (FUV) using the Sapphire II     technology.   "
27315|NCT02928198|"     The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the     efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold     provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive     subjects with and without fenestration towards the side branch.      Patients included in this study will be divided into three different cohorts:        -  Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.        -  Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.        -  Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.      All patients will also have telephone FU at 30 days, 12, 24 and 36 months.   "
27316|NCT02928185|"     The purpose of this study is to see what the patients perceptions are of the Coping Together     manuals during the first 100 days after their Hematopoietic Stem Cell Transplantation (HSCT),     and if they would make any changes to Coping Together manuals for future patients, caregivers     and couples that use these manuals after their HSCT. The investigators would also like to see     what is the caregiver's perception of this intervention, and to see if they have any     suggestions for changes. If the caregiver is interested in providing feedback, they will sign     a separate consent form.   "
27317|NCT02928172|"     Hypothesis:      There is a statistically measurable correlation between qNOX and rough clinical signs of     insufficient anti-nociception such as movements during Laryngeal Mask Airway (LMA) insertion,     skin Incision, LMA removal. It will reduce the problem of anticipating the nociception in     patients undergoing general anesthesia.      Objectives:        1. to compare two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the          Bispectral index (BIS™) (Covidien, Boulder CO. USA), in patients undergoing surgery          under sedation and general anesthesia.        2. to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and          the qCON index of hypnosis.        3. to assess qNOX reliability as a specific indicator of response to nociceptive          stimulation.   "
27318|NCT02928159|"     This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy     (LAP-ST) (primary outcome).   "
27319|NCT02928146|"     The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia     repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open     hernia repair.   "
27320|NCT02928133|"     Rationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias     need to be anticoagulated. It is not known whether non-vitamin K antagonist oral     anticoagulants (NOAC) in this patient group are efficient and safe.      Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for     thromboembolic prevention in atrial tachyarrhythmias in adult patients with congenital heart     disease (CHD).      Methods: In this multicenter prospective registry adult CHD patients with atrial     tachyarrhythmias on NOACs (switch from VKA or new on anticoagulants) will be followed for a     minimum of two years.      Primary efficacy endpoints are defined as thromboembolism, i.e. the composite of ischemic     stroke, systemic and pulmonary embolism and intracardiac thrombosis, and as the composite of     stroke and systemic embolism. Primary safety endpoint is defined as major bleeding according     to the ISTH criteria. Secondary endpoints include each thromboembolic or bleeding event     analysed separately, all-cause mortality, therapy adherence, quality of life, risk assessment     of stroke and evaluation of natural history of atrial tachyarrhythmia in adult CHD patients.      Primary endpoint assessment will be performed with a per protocol analysis, and demonstrated     as Kaplan Meyer estimates of event free survival and event rates per year.   "
27380|NCT02927353|"     To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the     safety of the study drug in healthy Japanese adult male subjects   "
27321|NCT02928120|"     Colorectal cancer (CRC) is one of the most common forms of cancer and the second leading     cause of cancer-related deaths in the western world.      CRC mortality is related to stage of disease with a five year survival for early-stage     disease of 77.0% and 50.8% for late stage disease. Methods for early detection of primary as     well as recurrent CRC are therefore important to increase patient survival. Tumour biomarkers     from blood, stool, or urine could aid the early diagnostics of CRC, but despite extensive     research such markers have only provided limited clinical value.      Sporadic CRC develops as a result of the accumulation of genetic and epigenetic alterations.     Epigenetic alterations include DNA hypermethylation, which through transcriptional silencing     of tumour suppressor genes is associated with cancer development and cancer progression. The     search for gene promoter regions hypermethylated in cancer has been ongoing for nearly two     decades, and a number of genes have been shown to be preferentially hypermethylated in CRC.     Therefore, hypermethylated DNA in plasma has been suggested as a marker for tumour-stage and     survival in CRC patients. The only approved biomarker for the detection of CRC recurrence is     the protein carcinoembryonic antigen (CEA). CEA is limited by its low sensitivity and     therefore not recommended as a diagnostic biomarker. Hypermethylation of CRC specific genes     as part of a molecular biomarker panel measured in blood could prove to be a recurrence     marker in CRC patients, with elevated sensitivity and specificity.      The aims of this project are to examine if hypermethylation of specific genes measured from     cell-free DNA in plasma of CRC patients can be used to detect primary CRC, to detect CRC     recurrence and to be a biomarker for CRC prognosis.      Development of a reliable sensitive and specific biomarker for CRC will immensely improve the     diagnostics and handling of CRC patients.   "
27322|NCT02928107|"     The aim of this project is to develop evidence that can inform hearing health care best     practices for adults between the ages of 65-75, and to determine what level of involvement by     the primary care practitioner (PCP) is required to inform and encourage adults age 65-75 to     follow through with routine hearing screening. The ultimate goal is to provide information to     implement changes in health care policy to facilitate accessible and affordable hearing     health care.      This project will compare implementation of three PCP-based hearing screening strategies that     include progressive levels of PCP time and guidance to complete telephone-based hearing     screening.Those who fail screening go on to a medical referral study and receive (1)     diagnostic audiological testing and (2) determination of the reliability and validity of     identification of conditions that should require medical referral prior to hearing aid     provision (called FDA 'Red Flag' conditions, including conditions such as sudden hearing     loss, cerumen impaction, conductive hearing loss, dizziness, external deformity, ear     drainage). Adults between the ages of 65-75 years old who are being seen for a routine     appointment at a participating Duke primary care site may be eligible to participate.      The primary outcome measure will be the proportion of subjects in Groups 1 and 2 who dial the     phone number and complete the test at or within two months of their PCP visit, relative to     Group 3.      Secondary outcome measures will be the proportion of subjects in all groups who: a) schedule     and b) complete the visit for diagnostic audiological testing, and subsequently, c) complete     a plan for appropriate hearing loss intervention, if indicated, within four months of initial     hearing screening. Physical exams and procedures associated with this study present no     significant risk to the participant.These are conducted routinely in the clinical     setting.There is the potential for loss of confidentiality.   "
27323|NCT02928094|"     The purpose of this study is to determine whether a single intracoronary infusion of an     adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4     (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional     class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life.     Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The     primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT)     duration. Long-term safety of Ad5FGF-4 will also be assessed.   "
27324|NCT02928081|"     The aim of this study is to determine whether the performance of extended lymphadenectomy in     association with pancreatoduodenectomy improves the long-term survival in patients with     pancreatic head ductal adenocarcinoma.Half of participants will receive pancreatoduodenectomy     with extended lymphadenectomy,while the other half will receive pancreatoduodenectomy with     standard lymphadenectomy.   "
27325|NCT02928068|"     The purpose of this study is to investigate the efficacy of a 12 week telehealth intervention     for families of children with autism spectrum disorders under the age of 6 years on child     participation and parent efficacy.   "
27326|NCT02928055|"     The primary objective of this RCT is explore the mechanism for Hemiplegic Shoulder Pain (HSP)     reduction due to treatment with peripheral nerve stimulation. We will explore the association     of subject-specific clinical and demographic information and pain relief from PNS. We will     explore the possible role of central sensitization mechanisms in perpetuating pain via     measures of sensory and pain perception. Lastly, we will explore the dose-response     association of muscle-contraction from PNS and pain reduction, completion of activities of     daily living (ADLs), and improvement in quality of life.   "
27327|NCT02928042|"     This study evaluates that P. aeruginosa, A. baumannii, and K. pneumonia which are obtained     from patients' tracheal aspiration culture who treated with mechanical ventilation will be     compared with Lactobacillus (LAB) members in the laboratory. The aim is to investigate the     probiotics' antimicrobial properties and effects on these bacteria's growth rate.   "
27328|NCT02928029|"     This study will be conducted in 2 parts. The phase 1b part will be an international, phase     1b, open-label, dose-escalation assessment of radium-223 dichloride administered with     bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint     is to determine the optimal dose of radium-223 dichloride in combination with     bortezomib/dexamethasone for the Phase 2 portion of the study.      The phase 2 part will be an international, phase 2, double-blind, randomized,     placebo-controlled assessment of radium-223 dichloride versus placebo administered with     bortezomib and dexamethasone, in subjects with relapsed multiple myeloma.      Up to approximately 30 total subjects in all dose cohorts combined will be treated in the     phase 1b part of the study and approximately 196 subjects will be enrolled in the phase 2     part of the study.   "
27458|NCT02926339|"     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on     tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to     either receive 3 anti-tobacco presentations or 3 presentations on a different topic,     unrelated to tobacco.   "
27333|NCT02927964|"     This phase Ib/II trial studies the side effects and best dose of toll-like receptor 9 (TLR9)     agonist SD-101 when given together with ibrutinib and radiation therapy and to see how well     they work in treating patients with grade 1-3a follicular lymphoma that has come back after a     period of improvement or no longer responds to treatment. Immunostimulants such as TLR9     agonist SD-101 may increase the ability of the immune system to fight infection and disease.     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Giving TLR9 agonist SD-101 with ibrutinib and radiation therapy may induce an immune response     and prolong anti-tumor response.   "
27334|NCT02927951|"     The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain     in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the     level of pain associated with walking. Consequently, it is hypothesized that the reduction in     pain will result in an increase in the amount of walking they do during the day, improvements     in their gait, balance, risk of falls and sleep patterns.   "
27335|NCT02927938|"     Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following     induction chemotherapy. However, a large majority subsequently relapse and succumb to the     disease. Currently, cytogenetics and molecular aberrations are the best prognostic     indicators; however, these factors cannot prognosticate accurately for individual patients.     Overall, the majority of patients with favorable or intermediate-risk AML will experience     relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less     than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably     translate into cure. This study is undertaken to determine whether the presence of LSCs has     prognostic value as well as to determine whether the presence of LSCs has predictive value.     This study has an observational component, whereby we intent evaluate whether the presence or     absence of LSCs is prognostic. This study also has an interventional component in which it     uses LSC status to determine whether favorable and intermediate risk AML patients in CR     receive consolidation with chemotherapy or allogeneic HCT.   "
27336|NCT02927925|"     The purpose of this study is to assess the clinical efficacy and safety of daratumumab in     relapsed or refractory natural killer/T-cell lymphomas (NKTCL).   "
27337|NCT02927912|"     This phase II trial studies the side effects of intraoperative electron beam radiotherapy     boost and to see how well it works in treating patients with stage I-II breast cancer     undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to     the tumor cavity during the breast surgery before reconstruction may be a better way to kill     tumor cells and shrink tumors.   "
27338|NCT02927899|"     This study is a sensory analysis of several different formulations of a novel     tomato-soy-arugula seed beverage in men with prostate cancer. Eating a diet rich in a variety     of fruits and vegetables has been associated with decreased risk of a variety of diseases,     including prostate cancer. Mixed vegetable beverages may be useful in prostate cancer     survivorship.   "
27339|NCT02927886|"     The objective of the study is to document the clinical efficacy and complications of     endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative     and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are     close to the placebo.   "
27341|NCT02927860|"     Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with     better sleep and increased activity.   "
27342|NCT02927847|"     The goal of this study is to evaluate the effects of a smoking cessation intervention     combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of     reward function and smoking cessation outcomes. The results of this study will provide     information about mechanisms contributing to smoking and smoking cessation and will help to     guide future treatment studies.   "
27343|NCT02927834|"     Chronic rhinosinusitis is a common disease that effects millions of people world wide.     Despite its frequency it is unclear what treatment options are the best for these patients.     Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long     term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally     oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps     (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study     to see if oral steroids benefit the treatment outcomes in those patients with chronic     rhinosinusitis without nasal polyps. In addition this study will look to see if a short     course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference     in outcomes.   "
27344|NCT02927821|"     Over 15 million family caregivers provide more than 85% of long-term care to older adults     with Alzheimer's Disease and Related Disorders. Caregivers typically assume care     responsibilities without training or support and may in turn experience multiple health risks     including depression. Providing evidence-based caregiver supportive programs on a wide scale     basis is identified by the National Alzheimer's Plan Act as a national priority. One approach     is to augment existing community-based services for older adults with a caregiver     evidence-based program. Adult day service (ADS) is one such growing and critical     community-based option for older adults with Alzheimer's Disease and related disorders but     which does not systematically address common caregiver challenges or burdens using     evidence-based programs. The purpose of the study is to: 1) evaluate the effectiveness of     Adult Day Services (ADS) Plus to improve caregiver well-being and reduce depressive symptoms     compared to routine ADS use at 6 months; and 2) evaluate long-term maintenance effects of ADS     Plus at 12 months on caregiver well-being and depressive symptoms. ADS Plus consists of 5 key     components: care management, referral/linkage, education about dementia, situational     counseling/emotional support/stress reduction techniques, and skills to manage behavioral     symptoms (e.g., rejection of care, agitation, aggression). Based on care challenges     identified by family caregivers, an ADS Plus Prescription is provided, a written document     detailing easy-to-use strategies to address specified care challenges and caregivers are     trained in their use. The proposed study will employ a practical trial design to assess the     effectiveness and uptake of ADS Plus on a large scale. Thirty ADS programs throughout the     U.S. varying in geographic location and staffing levels will be involved. A total of 300     diverse caregivers (150 in 15 ADS Plus sites; 150 in 15 ADS usual care sites) will be     enrolled.   "
27345|NCT02927808|"     This study will investigate the impact of motivational interviewing in achieving low-density     lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.   "
27459|NCT02926326|"     An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197     exposure in healthy male subjects.   "
27347|NCT02927782|"     Patients with persistent symptoms of cerebrospinal-fluid leakage (positional headache,     photophobia, nausea and vomiting, clear drainage from the wound, fluctuant subcutaneous     wound) after a primary repair should be considered for revision surgery to avoid potentially     serious complications including CSF (cerebro spinal fluid) fistula formation. Prolonged bed     rest immediatel after reapir of an ID () incidental durotomy) is widely accepted and     frequently applied. current literature provides supporting retrospective evidence that     prolonged bed rest may not be required after watertight closure of dural tears.      The purpose of this study is to further investigate the impact of prolonged bed rest on the     need for early reoperation following primary repair of an ID after lumbar spinal surgery. The     primary endpoint of this study is the difference in reoperation rate between the two study     groups to further investigate if either one or the other postoperative mobilisation regimen     provides a significant benefit in terms of persistent dural leakage.   "
27349|NCT02927756|"     Study purpose is to evaluate treatment outcome and survival in patient with aggressive     lymphomas transformed from Follicular Lymphoma.   "
27381|NCT02927340|"     This research study is studying a drug as a possible treatment for ALK-positive or     ROS1-positive non-small cell lung cancer (NSCLC).      The following drug will be involved in this study :        -  Lorlatinib   "
27350|NCT02927743|"     Inappropriate use of antibiotics in primary care is associated with Development of antibiotic     resistant strains. As part of a quality improvement program carried out in primary care in     Uruguay, Argentina, Paraguay and Bolivia, a cluster randomized control trial was performed.     The aim of the study was to assess whether the use of continuous evidence-based feedback     about management of respiratory tract infections could decrease use of antibiotics in Acute     bronchitis, common cold and acute otitis media.   "
27351|NCT02927730|"     The main purpose is to evaluate the correlation in qualitative and quantitative manner     between clinical diagnosis of retained placenta and histology. Secondly, to assess different     clinical parameters that are likely related to accuracy of the diagnosis of RPOC   "
27352|NCT02927717|"     Study purpose is to evaluate baseline clinical data, outcome after front-line Rituximab     containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma.      Also an histological central review is planned in order to re-assess baseline diagnosis     according to new 2016 World Health Organization (WHO) criteria.   "
27353|NCT02927704|"     The aim of this study is to estimate GCF MCP-1 levels of healthy and Aggressive periodontitis     (AgP) subjects and to compare MCP-1 levels between Localized AgP (LAgP) and Generalized AgP     (GAgP) to establish its predictive value/role for distinguishing LAgP and GAgP development.   "
27354|NCT02927691|"     Currently, there are no efficacious behavioral treatment approaches to address uncompensated     aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD).     This is of particular public health concern given that aspiration pneumonia is the leading     cause of death in persons with PD. The overarching aim of the proposed study is to determine     the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength     training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway     protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate     the results will lead to reductions in the risks associated with airway protective deficits.   "
27355|NCT02927678|"     Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic     therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic     therapy remains controversy due to the absence of validated marker of osteomyelitis     remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single     Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment     allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was     associated with recurrence in 70% of cases. The aim of our study was to evaluate     prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic     therapy.   "
27356|NCT02927665|"     The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM)     Integrated Dual Balloon System in Obese Subjects.   "
27357|NCT02927652|"     The goals of this project are aimed at the following:        1. Identifying psychiatric comorbidity in patients presenting to the HNSCS clinic 1F and          Duke Otolaryngology of Raleigh clinic using the validated assessment tool Brief Symptom          Inventory (BSI-18) and the patient control scale. The BSI-18 is an 18 question and          patient control an 8 item tool that takes about four minutes to complete.        2. Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via          the CG-CAHPS visit survey.        3. Examining relationships between psychiatric comorbidity and patient satisfaction.        4. Examining relationships between psychiatric comorbidity and healthcare system use.   "
27358|NCT02927639|"     To develop a text messaging intervention using MyDiaText and to determine whether such an     intervention will decrease HbA1c in children 12 to 18 years old. The intervention will     consist of daily text messages sent to the subject's personal mobile device. Previously     developed text messages based on the American Diabetes Association (ADA) behavior goals will     be used for this intervention. These will be adapted with input from the focus groups that     will be carried out with adolescents with Type 1 diabetes mellitus (T1DM). The details of the     intervention, such as frequency and timing of text messages, will be determined from input     obtained from the focus groups.   "
27359|NCT02927626|"     Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma     basing on immune microenviroment.The purpose of this study is to observe the efficacy of     routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.   "
27360|NCT02927613|"     This study aims to describe the patient characteristics, feasibility, and outcomes of an home     mechanical ventilation (HMV) program at a university hospital in Thailand.   "
27361|NCT02927600|"     The primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic     Responses (GR) interventions at breakfast or at dinner is the most effective for lowering     glycemic response of the subsequent standard meal.   "
27460|NCT02926313|"     A randomized control study aimed to investigate if suitable individualized seating provision     is effective for adult nursing home residents in reducing the incidence of pressure ulcers,     and increasing their quality of life and functioning.   "
27363|NCT02927574|"     Restenosis is still an issue after endovascular revascularization for femoropopliteal     occlusive disease. One approach to reduce the rates of restenosis and reintervention is local     application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a     systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated     Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal     disease.   "
27364|NCT02927561|"     In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk     for developing complications such as diabetic retinopathy (DR). Due to the increasing     prevalence of diabetes and high percentage of patients with uncontrolled disease,     cost-effective tools are needed with focused attention on diabetes prevention and management     in the current health system. The automatic retinopathy detection can enlarge the screening,     reducing the workload and costs compared to manual image graders.   "
27365|NCT02927548|"     This is a single-center retrospective study that evaluates the effectiveness and long-term     safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary     incontinence in women on a population of 500 patients with a mean follow-up of 6 years.   "
31531|NCT02873052|"     The MyoVista system is a novel electrocardiogram technology that provides non‐invasive     assessment of myocardial abnormalities by analyzing energy changes at the cellular level of     the myocardium.   "
27366|NCT02927535|"     Aim: To describe 1) The use of TNF blockers monotherapy in early arthritis in daily clinical     practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5     years of TNF blockers monotherapy 3) To evaluate predictive factors for TNF blocker response     monotherapy Type of study: Observational cohort study using cross-section and longitudinal     data.      Description of the project methodology        -  Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early          RA).A sub-analysis will be conducted among patients satisfying the ACR-EULAR 2010          criteria.        -  Data collected: Patient characteristics, Clinical data regarding RA and related          pathologies, Characteristics of treatments received The analysis will be conducted using          data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.        -  Analyses:             1. Frequency of use of TNF blockers monotherapy: we will calculate the % of patients               initiating TNF blockers monotherapy (Kaplan-Meier method), and we will describe the               type of TNF blocker, the route of administration, the dosage, and the place of the               TNF blockers monotherapy in the treatment strategy during the first 5 years.             2. Identification of potential predictive factors for initiation of TNF blockers               monotherapy: a survival curve (Kaplan-Meier) will be performed. The baseline               characteristics of the patients with regard to the initiation of TNF blocker               monotherapy during the first 5 years of the disease will be compared by univariate               analysis and Log-rank test will be performed in all variables. A stepwise               multivariate analysis (Cox analysis) will be performed.             3. Therapeutical effect: we will calculate the retention rate over time, and will               compare the changes in different variables in the group of patients who have               received TNF blockers monotherapy matched (using a propensity score) to 1,2 or 3               patients who have received TNF blockers in combination with synthetic DMARDs. We               will assess and compare DAS28 and HAQ at short term (after at least 8 weeks of               treatment) and long term (last available visit) in groups. The structural efficacy               was evaluated by the radiographic progression at last available visit. We will               identically estimate the drug effect depending on the TNF blocker used, by               calculating the retention rate and comparing DAS28 at short term and long term.             4. Identification of predictive factors for TNF blocker monotherapy response: To               evaluate the impact of baseline demographics and disease conditions on the DAS28               and HAQ response during the first 5 years will be compared by univariate and               multivariate analysis.      Expected results:      Increase knowledge on the use of TNF blocker monotherapy, its efficacy and retention rate,     and on predictive factors for TNF blocker monotherapy response in early RA patients.   "
27367|NCT02927522|"     Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase     the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective     therapy method was proved. According to our previous study, the central cholinergic system     impaired by the anesthesia and surgery play a very important role in the POCD and donepezil     an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged     mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable     and has minimal adverse events. In present study a multi-center randomized case control study     was conducted and we hypothesized that donepezil attenuate the POCD.   "
27368|NCT02927509|"     Aim: To describe 1) The use of TNF blockers in early arthritis in daily clinical practice in     France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years 3) To     evaluate predictive factors for TNF blocker response Type of study: Observational cohort     study using cross-section and longitudinal data.      Description of the project methodology        -  Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early          RA).A sub-analysis will be conducted among patients satisfying the ACREULAR 2010          criteria.        -  Data collected: Patient characteristics, Clinical data regarding RA and related          pathologies, Characteristics of treatments received The analysis will be conducted using          data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.        -  Analyses:             1. Frequency of use of TNF blockers: the % of patients initiating TNF blockers will be               calculated (Kaplan-Meier method), and the type of TNF blocker will be described,               the route of administration, the dosage, the association with other DMARDs and the               place of the TNF blockers in the treatment strategy during the first 5 years.             2. Implementation of EULAR recommendations: the percentage of patients that initiate               TNF blockers meeting the EULAR criteria for initiation will be estimated, and the               concordance coefficient Kappa with regard to such fulfilment and the initiation of               TNF blockers will be calculated, and disease severity outcome measures will be               compared depending on the fulfilment or not.             3. Identification of potential predictive factors for initiation of TNF blockers: a               survival curve (Kaplan-Meier) will be performed. The baseline characteristics of               the patients with regard to the initiation of TNF blocker during the first 5 years               of the disease will be compared by univariate analysis and Log-rank test will be               performed in all variables. A stepwise multivariate analysis (Cox analysis) will be               performed.             4. Therapeutical effect:the retention rate over time will be calculated, the changes               in different variables will be compared in the group of patients who have received               TNF blockers matched (using a propensity score) to 1,2 or 3 patients who have not.               The DAS28 and HAQ will be assessed and compared at the short term (after at least 8               weeks of treatment) and long term (last available visit) in groups. The structural               efficacy was evaluated by the radiographic progression at last available visit.The               drug effect will be identically estimated depending on the TNF blocker used, by               calculating the retention rate and comparing DAS28 at short term and long term.           6) Identification of predictive factors for TNF blocker response: To evaluate the impact          of baseline demographics and disease conditions on the DAS28 and HAQ response during the          first 5 years will be compared by univariate and multivariate analysis.      Expected results:      Increase knowledge on the optimal use of TNF blocker and on predictive factors for TNF     blocker response in early RA patients.   "
27369|NCT02927496|"     Current lymphedema management protocols are based on the use of simple measures of hygiene     (regular washing with soap and water, skin and nail care), use of topical antibiotics or     antifungal agents, exercise and footwear. This is considered the standard of care in most     endemic countries in the absence of any structured treatment programs. Previous controlled     clinical trials and extensive field experience have shown the benefit of these measures in     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the     progression of lymphedema.      In the present study, the progression of lymphedema in a group of patients who receive a     six-week course of doxycycline will be compared with that of a group who receives doxycycline     look-alike placebo tablets. However, both groups will be enrolled into a standardized     regimen of hygiene described above. Thus, patients enrolled in the placebo group also     will receive the current standard of care, and the placebo used in the study will help to     identify the benefits of doxycycline on a background of simple hygiene measures. The regimens     will be explained to all participants who will be trained to use established standardized     methods of hygiene and be effectively applying it prior to the initiation of the drug     treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common,     generic SOP with handouts that describes methods and the training schedule will be used so     that similar methods are employed across all sites.   "
27370|NCT02927483|"     The trial is designed as a randomized, multicenter, open label, comparative, 6 months,     clinical study.   "
27444|NCT02926521|"     The investigators' objective is to evaluate whether any of the various peripheral nerve block     catheter dressing strategies currently employed by the Boston Children's Hospital Regional     Anesthesia Service has any differential impact on specific outcome endpoints such as regional     block catheter dislodgement, catheter occlusion, catheter leakage, skin irritation, and skin     infection.   "
27371|NCT02927470|"     The purpose of this study is to understand how the brain allows individuals to keep     information in mind over brief intervals. During the experiment, participants will be asked     to maintain fixation while they attend to and remember different visual stimuli (e.g., the     location of a dot on the screen, the color of a circle, the orientation of a line, the speed     of a group of moving dots) on a computer monitor. Participants will make decisions about     these visual stimuli and indicate their decisions by pressing buttons or making eye     movements. Through the use of Transcranial Magnetic Stimulation (TMS) investigators hope to     understand the contributions of different anatomical areas while subjects perform this task.   "
27382|NCT02927327|"     The purpose of the study is to collect representative clinical images (head and whole-body     scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device     equipped with investigational software components in adult population. The images and summary     data from this study are intended for use in regulatory submission.   "
27383|NCT02927314|"     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in     subjects with NAFLD and NASH.   "
27372|NCT02927457|"     This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics     and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic     cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by     photoprovocation (PV).      Current study is two group study. In Group A, Patients with fewer than two active lesions     will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that     develop PV lesions at any time during this period, as determined by the local investigative     team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and     either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin     pharmacokinetic (PK) of study drug, for 28 days.      In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by     the investigators will be enrolled into group B and have one lesion treated with 1%     GSK2646264 and 1 lesion with placebo.      A completed patient will be defined as a subject who receives at least 25 days of study drug     and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients     will be followed for 28 days in Group A only or until complete resolution of induced PV     lesions, as determined by the investigator.   "
27373|NCT02927444|"     This study will assess the immunogenicity and safety of booster vaccination with NBP606     compared to the existing commercial vaccine, when given concomitantly with routine pediatric     vaccinations.   "
27374|NCT02927431|"     Danirixin (DNX) is a novel, selective, and reversible antagonist of the C-X-C chemokine     receptor (CXCR) 2 and has been shown to decrease neutrophil transmigration and activation to     areas of inflammation. An intravenous (IV) formulation of DNX hydrobromide (HBr) is being     developed as an anti-inflammatory agent for treatment of adults hospitalized with influenza     (IFV). While early therapy with antivirals decreases severity and duration of symptoms of     influenza, there are no drugs that have demonstrated clinical efficacy in randomized clinical     trials in this population. Current treatment guidelines for hospitalized IFV recommend     neuraminidase inhibitors as standard of care therapy. IFV studies in animals have     demonstrated that therapeutic treatment with the combination of a CXCR2 antagonist and a     neuraminidase inhibitor reduced lung neutrophils and showed trends for improvements in     clinical scores, lung function and pathology with no evidence of worsening outcomes,     including viral load. This Phase 2, randomized, double-blind (for IV DNX), placebo-controlled     (for IV DNX) 3-arm study will be the first study to determine the efficacy and safety of IV     DNX when co-administered (in all groups) with standard of care antiviral treatment     (open-label oral oseltamivir [OSV]) in subjects hospitalized with IFV. The primary objective     of the study is to assess the efficacy of treatment with IV DNX twice daily given with oral     OSV compared to oral OSV twice daily on time to clinical response (TTCR). In this study,     subjects will be randomized in a 2:2:1 ratio to 15 milligram (mg) free base equivalent (FBE)     IV DNX, 50 mg FBE IV DNX, or matching placebo twice daily. All subjects will also receive     open-label 75 mg oral OSV, twice daily (given as standard of care). The study treatment     duration will be for up to 5 days. The investigator may elect to continue treatment with OSV     after 5 days of study treatment. Follow up will continue until Day 45 for all subjects. The     study will begin with enhanced safety monitoring in sentinel cohorts, leading to stepwise     enrollment of subjects. Subjects will be enrolled based on increasing levels of renal     impairment, and less severe hospitalized subjects will be enrolled prior to enrollment of     critically ill subjects, as this is the first study conducted in the hospitalized population     with severe IFV. Approximately 300 subjects are targeted to be enrolled in the study.   "
27375|NCT02927418|"     The purpose of this study is to explore the effects of a strength & conditioning (S & C)     program on risk factors for injury (Y-balance and Functional Movement Screen scores), as well     as parent reported injury occurrence in 12-16 year old male and female athletes. Forty girls     and 40 boys aged 12-16 will be recruited; half will participate in supervised S & C sessions     2-3x/week while the other half will continue with their regular sports and activities. Risk     factors for injury and performance indices (20 m sprint and multiple jump test) will be     assessed before and after the 4 month study. Injury occurrence will be recorded via bi-weekly     phone calls to the parent and athlete.   "
27376|NCT02927405|"     There is an increasing trend on decreasing narcotic use and maximizing efficiency in the     perioperative care. There are no studies that have compared a TAP block versus a TAP block     plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin     and receiving a TAP block decrease post-operative morphine consumption. It will be a     randomized controlled, double blind study, with 130 patients between 18-60 years; that will     undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea,     vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because     gabapentin will be used to decrease visceral and central pain, and TAP block will decrease     somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse     effects and improve pain management.   "
27377|NCT02927392|"     The physiological relevance of brown adipose tissue (BAT) in humans is largely unknown. The     investigators have shown that suppressing ovarian function in premenopausal women reduces     resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). The     investigators preliminary data suggest that this may be due, in part, to reduced brown     adipose tissue (BAT) activity. The overarching hypothesis is that BAT activity in humans is     modulated by E2. To determine if natural declines in endogenous E2 contribute to changes in     BAT activity, we will compare BAT activity in pre-and post-menopausal women. The     investigators will also explore whether suppression of ovarian hormones in pre-menopausal     women impairs BAT activity. BAT activity will be quantified using dynamic positron emission     topography/computed tomography (PET/CT) imaging combined with 11C-acetate tracers. We will     assess the thermogenic response of BAT by measuring cold-induced changes in REE, shivering,     and skin and core temperature.   "
27378|NCT02927379|"     This study aims to compare the effects of local wound infiltration with ketamine versus     dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower     abdominal cancer surgery.   "
27396|NCT02927145|"     This is an open-label, multi-centre Phase I/IIa dose escalation blood-stage malaria CHMI     trial to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine     RH5.1/AS01. All volunteers recruited will be healthy, malaria naïve adults aged between 18     and 45 years.      Volunteers will be recruited and vaccinated at the CCVTM, Oxford; Guys and St Thomas' NIHR     CRF, London; and the NIHR WTCRF, Southampton for the Phase Ia part of the trial, and at the     CCVTM, Oxford and Guys and St Thomas' NIHR CRF, London for the Phase IIa stage.   "
27379|NCT02927366|"     This is a non-confirmatory, randomized, subject and investigator blinded, placebo controlled     study of QCC374 in PAH patients. The study will have 2 parts. In Part 1, an initial safety     cohort, 8 subjects will be randomized in a 6:2 ratio and the starting dose will be 0.03 mg     b.i.d.. In Part 2, ~ 30 subjects will be randomized in a 2:1 ratio, with a planned starting     dose of 0.06 mg b.i.d.. In both Parts, subjects will be up-titrated during the first two     weeks of the study to 0.12 mg b.i.d, or to their maximum tolerated dose (MTD) if their     individual MTD is below 0.12 mg b.i.d. during the first two weeks of the study. The treatment     duration is 16 weeks.   "
27384|NCT02927301|"     This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant     atezolizumab in participants with Stage IB, II, or IIIA NSCLC who are eligible for surgical     resection with curative intent. Neoadjuvant therapy will consist of two 21-day cycles with     atezolizumab. Following surgery, adjuvant therapy will consist of up to 12 months of     atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy.   "
27385|NCT02927288|"     The purpose of this study is to develop a new test to help diagnose mild traumatic brain     injury (mTBI) and post-traumatic stress disorder (PTSD) in soldiers. Chemicals in the brain     will be measured using a Magnetic Resonance Spectroscopy (MRS) scan. In the study, the     investigators will compare the information they obtain from scans of participants with mTBI,     PTSD or both, to scans from healthy volunteers to understand the differences between these     groups. If the results can tell the difference between participants with mTBI and PTSD, the     investigators should be able to help safely diagnose patients in the future.   "
27386|NCT02927275|"     The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive     functioning during activity. Evaluation was accomplished by having participants perform     standardized cognitive tests while in three forms of low-intensity exercise and then     comparing results to performance when sitting.   "
27387|NCT02927262|"     The purpose of this study is to compare relapse-free survival (RFS) between subjects with     FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia     (AML) in first complete remission (CR1) and who are randomized to receive gilteritinib or     placebo beginning after completion of induction/consolidation chemotherapy for a two-year     period.   "
27388|NCT02927249|"     This randomized phase III trial studies how well aspirin works in preventing the cancer from     coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2)     breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that     reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer     prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast     cancer.   "
27389|NCT02927236|"     Background:      More effective treatments for people with cocaine use disorder are needed. Researchers want     to understand the parts of the brain involved in the disorder. Transcranial magnetic     stimulation (TMS) stimulates parts of the brain. A form of TMS called intermittent     theta-burst stimulation (iTBS) may help reduce cocaine use. Researchers want to learn how the     brain might change with treatment.      Objectives:      To test if iTBS can reduce cocaine use. Also, to learn how cocaine changes the heart and the     brain.      Eligibility:      Healthy, right-handed adults ages 18-60 who do or do not have cocaine use disorder.      Design:      Participants will be screened with:        -  Questionnaires        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Alcohol breath tests      In the pilot study, 10 participants with cocaine use disorder will have 10 treatment days     over 2 weeks. Half will be inpatient and half will be outpatient. They will have 2 follow-up     visits. Treatment includes:        -  iTBS: A coil is placed on the head. A brief electrical current passes through the coil.          They view cocaine-related images during each session. Sessions are videotaped.        -  Repeat of screening tests             -  In the main study, participants will be randomly assigned to have either real or               fake iTBS.             -  Participants with cocaine use disorder will join an incentive program to quit.             -  Participants will have 39 visits over 6 months. These include:        -  Repeat of screening tests        -  MRIs at 5 visits: Participants lie on a table that slides into a cylinder that takes          pictures of the brain. They respond to images while in the scanner.        -  iTBS at 10 visits (5 days a week for 2 weeks)      Participants will be contacted throughout the study to discuss iTBS treatment and drug use.   "
27390|NCT02927223|"     To test the hypothesis that increasing the sinus node rate with atropine treatment prior to     exercise will reduce exercise-triggered ventricular ectopy compared to baseline in patients     with CPVT.   "
27391|NCT02927210|"     This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men     to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of     Dimethandrolone Undecanoate (DMAU) administered as an intramuscular or subcutaneous     injection.   "
27392|NCT02927197|"     The purpose of this study is to examine changes in multiple cognitive skills after completing     60 hours of cognitive training with ThinkRx, a LearningRx program.   "
27393|NCT02927184|"     This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering     LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver     disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of     the treatment period (Week 12). Secondary endpoints include effects on liver fat content and     other liver and lipid markers, as well as effects on safety and tolerability, and     pharmacokinetic (PK) measurements.   "
27395|NCT02927158|"     This study is designed to utilize whole exome and whole genome sequencing techniques to     identify underlying genetic causes for undiagnosed disorders in the Plain Communities, and to     do population genetic studies looking at genetic drift and founder mutations in this unique     population.   "
27397|NCT02927132|"     This research seeks to evaluate expressive writing as a novel intervention for problem     drinking among college students. The vast majority of individually focused brief     interventions targeting college drinking have focused on personalized feedback approaches and     recent innovations have largely been limited to finer distinctions of these, which require     assessment and programming for implementation. The present research proposes expressive     writing as a novel alternative, which has been used extensively in other domains but not as     an alcohol intervention strategy.      H1a: Participants writing about negative drinking events will show reduced drinking and     drinking-related negative consequences relative to students in the neutral control group.      H1b: Participants writing about distressing non-alcohol events will show increased     psychological wellbeing relative to students in the neutral control group.      H1c: Participants writing about negative drinking events will show reduced drinking and     consequences compared with an empirically-supported brief intervention (i.e., PNF). This is     an exploratory hypothesis.      H2a: Alcohol narratives will have stronger effects on alcohol outcomes relative to distress     narratives.      H2b: Alcohol guilt narratives will have the strongest effect on alcohol outcomes relative to     all other conditions.      H3a: Expression of guilt, assessed by self-report and by content coding with LIWC, will     mediate intervention effects on drinking outcomes.      H3b: Change thought, assessed by LIWC coding, will mediate intervention effects on drinking.   "
27398|NCT02927119|"     The purpose of the investigation is to assess iodine status of pregnant women at week 16 of     gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The     investigators aim to assess whether pre-gestational initiation of iodine supplementation is     more advantageous in comparison to supplementation start at the time of pregnancy detection.   "
27400|NCT02927093|"     The Shoklo Malaria Research Unit (SMRU) provides care to refugees and migrant populations     along the Thai-Burma border since 1986. Services include antenatal and birthing care, with     2,500 births per year and Special Care Baby Units (SCBU) set up in 2008; all medical records     including clinical and laboratory data are archived. The treatment of neonatal jaundice is     based on treatment thresholds adapted from the neonatal jaundice guidelines, published by the     Royal College of Obstetricians and Gynaecologists, UK. Total serum bilirubin (SBR) is done at     regular intervals to monitor neonatal hyperbilirubinemia (NH) evolution, following SMRU     guidelines. The SCBU have been set up to provide intensive care for neonates in a resource     constrained setting and don't have equipment for assisted ventilation other than oxygen     therapy. Neonates presenting with high serum bilirubin levels and/or clinical signs of acute     bilirubin encephalopathy (ABE) cannot receive exchange transfusion on site and have to be     referred to the Thai general hospital one hour drive from the clinics; and, for those     neonates surviving, there has not been a systematic follow-up of their growth and     neurodevelopment.      The study will consist of a matched case-control series and a retrospective review of SCBU     charts of neonates with NH reaching exchange transfusion threshold. The SCBU database will be     searched for neonates born at ≥ 28 weeks of gestation hospitalized for phototherapy between     January 2009 and December 2014; charts will be manually researched to identify study     participants which will be classified as NH reaching exchange transfusion threshold (cases)     or as NH within moderate threshold (controls). Additionally neurological signs compatible     with ABE will be searched in the clinical notes and coded as present/absent. Cases discharged     alive from the SCBU will be traced back to evaluate their clinical and neurocognitive long     term outcome. Each case will be matched with a moderate NH control from the same clinic, sex,     gestational age and season of birth and hospitalized within the same month.      The results of this study will help to improving the clinical care during the neonatal period     and to developing a guideline for a better follow-up of children with NH reaching exchange     transfusion threshold.   "
27401|NCT02927080|"     Study A083-02 is a multicenter, Phase 2 study to evaluate the safety, tolerability,     pharmacodynamics (PD), efficacy, and pharmacokinetics (PK) of ACE 083 in patients with FSHD     to be conducted in two parts. Part 1 is open-label, dose-escalation and Part 2 is randomized,     double-blind, and placebo-controlled.   "
27402|NCT02927067|"     The purpose of this study is to compare the efficacy and safety of maribavir to     valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic     hematopoietic stem cell transplant recipients.   "
27403|NCT02927054|"     A questionnaire was provided, including clinical vignettes and free text answers, to assess     and evaluate the ability of resident physicians to identify systemic inflammatory response     syndrome (SIRS), sepsis, and severe sepsis. Questionnaire scores were compared between     specialties. A whole-hospital educational campaign was provided with the aim to improve     sepsis recognition, and the questionnaire survey was repeated after one year to assess the     effect of the education on the recognition of sepsis.   "
27404|NCT02927041|"     The gold standard in hemodynamic evaluation has been the combined use of echocardiography and     right heart catheterization. Fall backs to echocardiography are its time consumption and     requirement for specialist interpretation while the Swan-Ganz® catheter shows a poor     correlation of central venous pressure to volume status and provides indirect and difficult     to interpret measurements in patients with unique pathophysiological states.      Next generation continuous hemodynamic transesophageal echocardiography (hTEE®) is being     increasingly utilized to assist with complex resuscitations and to monitor the hemodynamic     profiles of critically ill patients. hTEE is proving to be an essential diagnostic,     therapeutic and monitoring tool for the rapid evaluation of the hemodynamic state in the     critically ill patient and or hemodynamically compromised patient.      The purpose of this observational study is to evaluate the role of hTEE in clinical     decision-making in 30 patients recruited from OR-Trauma and in 30 patients from the     Cardiovascular-OR. Hemodynamic trans-esophageal echocardiography (hTEE) incorporates an     FDA-approved miniaturized, disposable probe for continuous use in patients for up to 72     hours. This device has been used for postoperative assessment in the ICU for several years     with successful placement of probes and without any adverse incidents.      The probe allows for the rapid, intermittent or continuous evaluation of bi-ventricular     function, volume status and valve function at bedside or intraoperatively. It also allows for     the evaluation of pericardial effusions and or the exclusion of pericardial tamponade.   "
27405|NCT02927028|"     With an emphasis on oral processing, this study seeks to characterize the mechanisms that     account for the high satiation properties of walnuts and low energy yield during digestion.   "
27406|NCT02927015|"     Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release     from products in a pilot human study.   "
27407|NCT02927002|"     The goal of this project is to study the effect of noninvasive brain stimulation on     decision-making and on brain activity in impulse control disorders.   "
27461|NCT02926300|"     The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients     who has history of FURESTEM-CD injection at least once.   "
27410|NCT02926963|"     Chronic granulomatous disease (CGD) is a rare genetic disease of innate immune due to the     malfunction of phagocytic cells unable to destroy pathogens during infection. The four genes     implicated are CYBB, CYBA, NCFA and NCF2 respectively encoding Nox2, p22phox, p47phox and     p67phox. Nox2 analogs have recently been discovered in cells other than phagocytes. So the     question arises on physiopathological impact of the absence of theses proteins not only in     phagocytes but also in other cells types such as fibroblasts or neurons.      The principal objective is thus to study the impact of protein deficits Nox2 and p22phox, in     the pathophysiology of neurons from inducible pluripotent bone marrow cells (iPSC).      For this purpose, a collection was built of fibroblasts and keratinocytes from patients with     different forms of CGD to get iPSC similar to embryonic marrow cells and differentiable into     several cell types (neurons, phagocytes).   "
27411|NCT02926950|"     Primary Objective:      To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c)     reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control with     metformin.      Secondary Objectives:        -  To compare sotagliflozin versus placebo for:        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.        -  Change from baseline in fasting plasma glucose (FPG);        -  Change from Baseline in systolic blood pressure (SBP) for patients with baseline SBP          ≥130 mmHg;        -  Change from baseline in SBP for all patients;        -  Change from baseline in body weight;        -  Proportion of patients with HbA1c <6.5% and <7.0%.        -  To evaluate the safety of sotagliflozin versus placebo.   "
27578|NCT02924766|"     The purpose of this study is to assess the safety and pharmacokinetics of niraparib when     administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or     abiraterone acetate plus prednisone) in adult men with metastatic castration resistant     prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.   "
27412|NCT02926937|"     Primary Objective:      To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c     (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control     on diet and exercise.      Secondary Objectives:        -  To compare sotagliflozin dose 1 versus placebo based on:        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal;        -  Change from baseline in fasting plasma glucose (FPG);        -  Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP          ≥130 mmHg;        -  Change from baseline in SBP for all patients;        -  Change from baseline in body weight;        -  Proportion of patients with HbA1c <6.5%, <7.0%.        -  To compare sotagliflozin dose 2 versus placebo based on:        -  Change from baseline in HbA1c        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal;        -  Change from baseline in body weight;        -  Change from baseline in SBP for all patients.        -  To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo.   "
27413|NCT02926924|"     This is a prospective randomized study evaluating the use of a prophylactic incision wound     vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a     BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs.     vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim,     the patients' postoperative care can proceed as usual. Our primary outcomes will be     antibiotics or return trip needed to the operating room for wound related complications.      The patients only intervention would be the application of an incisional wound vac. The will     be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.   "
27414|NCT02926911|"     This study looks at the risks and benefits of active surveillance (AS) compared to guideline     concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk     DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ     (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes     compared to GCC.   "
27416|NCT02926885|"     Evaluation of a new technique of liver retraction for the exposure of the His angle in     gastric bypass Roux-en-Y surgery.   "
27417|NCT02926872|"     The primary outcome of this study is the development of a clinical profile of pediatric     patients with LAL-D, which will enable the Sponsor to provide more focused guidance to the     medical community as to which pediatric patients should be tested for LAL-D.   "
27418|NCT02926859|"     Current antipsychotic treatments of schizophrenia are only partially effective, and their use     is often associated with serious side effects. Cannabidiol is a natural counterpart of the     psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic     or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in     acute paranoid schizophrenia we showed a statistically significant clinical improvement in     all symptoms clusters of schizophrenia compared to baseline with either treatment.     Cannabidiol displayed a significantly superior side-effect profile in particular regarding     prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect     profile and potentially novel mechanism of action identify this molecule as a potential     antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to     evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance     treatment of schizophrenia in comparison to placebo as an add-on to an established treatment     with either quetiapine or amisulpride, in a 12-months, double-blind, parallel-group,     randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's     antipsychotic potential will be gained.   "
27419|NCT02926846|"     This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics     with adjunctive lavage can improve the outcome of severe peritoneal dialysis related     peritonitis.   "
27420|NCT02926833|"     This is a phase 1-2, open-label study in subjects with refractory DLBCL, evaluating the     safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR) T     cell therapy, in combination with atezolizumab, a humanized, monoclonal antibody that binds     to PD-L1 and blocks interaction with the PD-1 and B7.1 receptors. The trial will be separated     into two distinct phases designated as phase 1 and phase 2.   "
27457|NCT02926352|"     There are two specific aims for this study. Aim 1 is to test whether low-level laser therapy     (LLLT) can enhance the efficacy of fear extinction training in the modification of     pathological fear. Aim 2 is to investigate the efficacy of low-level laser therapy (LLLT) as     a stand-alone intervention for anxiety/phobias.   "
27421|NCT02926820|"     There is a paucity of investigation into effective interventions to enhance cognitive     function and/or mitigate cognitive decline in individuals with Huntington disease (HD). This     study targeted working memory (WM), which is the ability to actively hold information in the     mind in order to perform complex mental tasks, given reports of WM dysfunction in patients     with HD. The investigators examined the feasibility of conducting a 5-week WM training     program (Cogmed). Patient adherence and treatment tolerance were assessed. In addition,     preliminary evidence for the efficacy of this training program on targeted cognitive     abilities was examined. Nine patients with pre-manifest or early stage HD underwent training.     Patients were assessed before the intervention and one week after completion.   "
27422|NCT02926807|"     A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD     matched for sex, age and coronary artery disease risk factor with the AD subjects will also     be included. All subjects will undergo the following imaging procedures: a 18FDG-PET to     quantify vascular inflammation in the ascending aorta and carotids and a MDCT to calculate     the Agatston score. Skin and blood biomarkers will also be assessed.   "
27423|NCT02926794|"     Two hundred and ninety-three college students who reported drinking in the past month were     randomly assigned to condition in a 2 (self-affirmation: values vs. control writing task) x 2     (implementation intentions: formed vs. not formed) between-subjects factorial design.     Participants first completed a self-affirmation or control writing task, then read an article     describing the risks of drinking. Next, all participants reported their common drinking     behaviors and contexts, and then selected two harm-reduction strategies making either general     intentions to use the strategies or making implementation intentions to use the strategies.     Alcohol consumption was measured 1 and 2 weeks after the experimental session.   "
27425|NCT02926768|"     CK-101 is a novel, potent, small molecule tyrosine kinase inhibitor (TKI) that selectively     targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type     (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety     profile of oral CK-101; to determine the maximum tolerated dose (MTD) and/or recommended     Phase 2 dose (RP2D) of oral CK-101; to assess the safety and efficacy of CK-101 in previously     treated NSCLC patients known to have the T790M EGFR mutation.   "
27426|NCT02926755|"     The goal of this study is to use three (3) different imaging techniques:Fractional Flow     Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is     more reliable than pictures alone to determine the significance of blockages in the heart;     Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about     the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence     Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque     thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have     suffered a recent heart attack, underwent successful opening of the artery with a stent, and     have blockages greater than or equal to 50% in one or more of the other arteries to the     heart; and to correlate this findings with cardiovascular outcomes at 1 year.   "
27427|NCT02926742|"     This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using     EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE   "
27428|NCT02926729|"     This research is studying a new investigative imaging instrument called a nonlinear     microscope (NLM). A nonlinear microscope can produce images similar to an ordinary     pathologist's microscope, but without first processing tissue to make slides. This study will     determine if a NLM can be used to evaluate tissue during lumpectomy surgery for breast cancer     in order to reduce the probability that standard pathologic examination of the specimen after     the end of the operation will find close or positive margins, thus possibly requiring the     patient to have additional breast surgery.   "
27429|NCT02926716|"     As the proportion of early gastric cancer has been steadily increased in Korea, so has     function-preserving surgery. The function preserving surgery is characterized by the     minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter     than those of standard gastrectomies.      Currently, there is only one way to identify resection margin status in gastric cancer,     'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition,     the results rely on the pathologist's expertise, thereby it showed limitation of its     accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous     study.      Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated     that this emerging technique is useful to identify the gastric tumor margin more clearly in     vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that     NBI may allow reliable delineation of tumor and identification of resection margin status in     the specimen after gastrectomy for gastric cancer.   "
27430|NCT02926703|"     The investigators compared the feasibility of serum creatine kinase and serum lactate     concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures     (GTCS) and syncopes in clinical settings that require fast-action treatment, such as in the     emergency departments.   "
27431|NCT02926690|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167     administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or     metastatic breast cancer.   "
27455|NCT02926378|"     Based on the evidence, a pre-post test pilot study design will be implemented to clarify the     benefits of an acupuncture intervention before and after treatment. The initial assessment     will contain a brief demographic interview and a review of medical records, and both pre and     post-intervention evaluations will comprise an imaging protocol that includes RS-fMRI, pCASL,     diffusion kurtosis imaging (DKI), and a brief cognitive assessment, as described in greater     detail below. Several quantitative measures within DMN regions will be generated and compared     between pre- and post-acupuncture therapy. These include 1) RS-fMRI measures such as     connectivity strength and fractional amplitude of low frequency fluctuations (fALFF); 2)     regional CBF measured with pCASL; 3) water diffusion measures for microstructural changes     with DKI.   "
27432|NCT02926677|"     This study is designed to examine three treatment conditions for traumatized youth:     Cue-Centered Treatment (CCT), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT), and     Treatment as Usual (TAU) to determine which treatment works most effectively for which youth.     The investigators would like to determine feasibility of training on the treatment     interventions. In addition, this study aims to inform development of systems of care for     chronically traumatized youth.      The investigators hope to determine whether 1) TF-CBT and CCT will have better outcomes than     TAU, 2) Child characteristics predict better outcome in either TF-CBT or CCT and to identify     which phases of treatment are most effective, and 3) Imaging findings will be predictors of     improved outcome. This research is important because while there are many existing trauma     interventions for youth, little is known about what is most essential in those interventions.     This study will shed light on what components of treatment are most effective. Furthermore,     there are minimal guidelines on how to select the most appropriate intervention for a     particular child. This study will contribute to that knowledge by informing which     interventions are suited best for which youth.   "
27433|NCT02926664|"     The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure     Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of     Sepsis, i.e. an initial qSOFA of at least of 2.   "
27434|NCT02926651|"     As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose     regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to     determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in     hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following     primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for     transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly     minimize post-operative blood loss and transfusion requirements compared to the use of a     single dose regime.   "
27579|NCT02924753|"     This is a study for patients who have been previously treated for B-ALL. The purpose of this     study is to determine the safety and feasibility of CART-19 cells to the patients with     relapsed and refractory CD19+ B-ALL.   "
27435|NCT02926638|"     This randomized phase II/III compares rilotumumab when given together with erlotinib     hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV     squamous cell lung cancer that has come back after previous treatment. This is a sub-study     that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte     growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells to grow     more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink tumors.     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib     hydrochloride works better than erlotinib hydrochloride alone (standard treatment) in     treating squamous cell lung cancer.   "
27436|NCT02926625|"     Fevers in childhood are common and usually self-resolve. In sub-Saharan Africa, when a     febrile child presents to a community health worker (CHW), the child is assessed for malaria,     pneumonia, and diarrhea, and other danger signs, according to WHO guidelines for integrated     Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no     danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the World     Health Organization (WHO) recommends that all children be reassessed in 3 days. It is     hypothesized that health outcomes for these cases will be equivalent if the CHW advises to     come back in 3 days only if symptoms have not resolved. In order to assess this hypothesis, a     two-arm cluster-randomized, community-based non-inferiority trial in Southern Nations,     Nationalities and People's Regional State (SNNPR) in Southwest Ethiopia will be conducted to     assess the non-inferiority of CHW-advised systematic follow-up on day 3 compared to     conditional follow-up for non-severe febrile illness in children age 2 to 59 months, in which     no cause of fever can be identified and where danger signs are absent.   "
27437|NCT02926612|"     This is a multicenter prospective collection of leftover respiratory tract secretions, paired     blood and NP swabs, and clinical circumstances from pediatric HCT patients, followed by next     generation genomic sequencing, transcriptome analysis, protein biomarker measurement, and     statistical modeling.   "
27438|NCT02926599|"     Simulated environment allowed safe learning of critical events and knowledge of appropriate     response and treatment. Anesthesiology resident education curriculum in Lyon plans several     high fidelity simulation session with a large panel of critical events. Anticipation of     critical events before they may occur and planification of team resources and priority in the     treatment strategy may help to improve team performance during the scenario. The     investigators' goal is to compare individual and team performances with or without an     optimization personal potential training.   "
27439|NCT02926586|"     The purpose of the study is to determine whether Fludarabine in combination with cytarabine     is more effective than high-dose cytarabine in post-remission therapy for patients with     core-binding factor acute myeloid leukemia   "
27440|NCT02926573|"     The study will involve adult otolaryngology patients over the age of 18 years undergoing open     or endoscopic/robotic tumor resection involving the mucosal surfaces of the oral cavity,     oropharynx, hypopharynx and larynx at Washington University Medical Center. Eligible patients     will be recruited from the otolaryngology head and neck cancer clinic during preoperative     visits. Participants will be randomized to active or placebo drug and will receive study drug     twice a day from Post-Op Day 0 and conclude Post-Op Day 2. Questionnaires will be collected     pre-and post-operatively.   "
27441|NCT02926560|"     The aim of this study is      1) To describe the level and determinants of methotrexate adherence in patients with chronic     inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in     the department of rheumatology in the Nîmes University Hospital   "
27442|NCT02926547|"     1. Identify the tissue proteins associated with early breast cancer invasion phases without          lymph node involvement .        2. Consider their role in the invasion and the risk of tumor spread .   "
27443|NCT02926534|"     The purpose of this study is to assess the prevalence of COPD among individuals aged 35 - 59     years based results of spirometry before and after bronchodilator, presence of structural     changes in lungs (emphysema, inflammatory changes and thickening of the walls of the large     and small airways)detected by computer tomography as well as the symptoms of COPD. The study     has three study groups: smokers of conventional cigarettes; those who had quit smoking 1 - 5     years ago, and those who haven't smoked cigarettes.   "
27445|NCT02926508|"     Recently, there has been an emerging interest in how manipulating gut microbiota (which is     composed by microorganisms living in our digestive system) can influence learning, memory and     cognition. This influence is thought to primarily occur via the gut endocrine and immune     systems, and the vagus nerve, all of which influence brain function and are modulated by     intestinal microorganisms. One way to manipulate the microbiota is to ingest dietary     compounds, such as prebiotics.      Prebiotics are non-digestible dietary fibres that enhance the growth of healthy bacteria in     the intestines when given in adequate amounts. Prebiotics are relatively stable, can be     stored at room temperature and can be easily added to foods or drinks. They are not degraded     by enzymes and acids in the digestive tract; therefore they reach the colon relatively     unchanged, where they are metabolised by specific bacteria, thus promoting their beneficial     effects. Prebiotics can be found in very small proportions in vegetables and fruits such as     leeks, onions, tomatoes, garlic, etc., but this naturally occurring quantity is generally     insufficient to promote a significant growth of beneficial bacteria. Therefore, large     quantities of purified prebiotics are available as powder supplements and sold in packages of     the appropriate dose.      Pre-clinical studies in animals have shown that prebiotics modulates brain expression of key     molecules involved in cognition and brain health in rats. These findings therefore highlight     the potential of influencing cognition through the manipulation of gut microbiota (in this     case, via the ingestion of a prebiotic).      Building on this evidence, the aim of this study is to investigate how manipulating gut     microbiota can influence reading, learning and behaviour in a group of children whose reading     scores suggest there is room for improvement.   "
27476|NCT02926105|"     This study compares the effects of three home-based exercise programmes in at-risk to     falling older adults living in their own home on the incidence of falls (number and     severity), risk factors, and quality of life as well as on the adherence to exercise. The     subjects will be randomized and allocated in three groups. The group A will receive the     Test-and-Exercise home-based programme (T&E), the group B will receive the Otago     home-based exercise programme and the group C (activ-control group) will receive the     Helsana booklet   "
27477|NCT02926092|"     The purpose of this study is to gain an understanding of how adRP progresses over time in     patients with misfolded rod opsin mutations.   "
27590|NCT02924597|"     To evaluate the feasibility and efﬁciency of zero ischemia robot-assisted laparoscopic radio     frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with     robot-assisted laparoscopic partial nephrectomy without hilar clamping.   "
27446|NCT02926495|"     Hypertension is a serious public health issue, affecting approximately 30% of adults.     Hypertension greatly contributes to the risk for heart disease and stroke, both among the top     three leading causes of death in the Americas, Europe, and Asia. While most treated     individuals with hypertension are controlled on medication, diet and exercise, an estimated     12% are resistant to conventional medical intervention. Alternative effective treatments are     still needed for this hypertensive patient population to mitigate the risk and incidence of     mortality and morbidity.      This original Investigational Device Application is for a study intended to confirm the     safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin system     to treat resistant hypertension. The eCoin device delivers electrical stimulation pulses to     the median nerve from a small coin sized device placed under the skin of the distal anterior     forearm. The implant delivers a weekly 30 minute treatment based on previous studies showing     a long lasting and cumulative effect. The safety and efficacy of eCoin therapy has previously     been demonstrated in a multinational, randomized, double-blind, sham-controlled study in New     Zealand, Taiwan and Canada.      This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled study     of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with     drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted     subcutaneously in the right and left forearms of patients with uncontrolled hypertension     despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing     period, subjects will be 1:1 randomized into either a treatment or control group. One half of     the subjects have their devices activated (treatment) and the other half undergo a sham     activation (control) to maintain participant blinding to their treatment allocation. During     the six months post-randomization, the eCoin is ON in the treatment group and OFF in the     control group.   "
27447|NCT02926482|"     This is a cluster-randomized controlled trial designed to increase the availability of     buprenorphine treatment slots in specialty addiction treatment organizations to treat opioid     use. The intervention being tested is a bundle of buprenorphine prescriber capacity building     practices called the Physician Recruitment Bundle (PRB). For the study, 70 organizations will     be identified and recruited, and those organizations will then be randomized into one of two     arms: 1) control, and 2) PRB: organizations implementing the PRB using the Network for     Improvement of Addiction Treatment (NIATx) Organizational Change Model. The primary research     question is to test the impact of the PRB, relative to the control, on increasing the number     of assigned physician buprenorphine slots in specialty addiction treatment organizations.   "
27448|NCT02926469|"     The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual     Reality (VR) during labor. We will also explore whether VR distraction is helpful for     reducing subjective pain during labor, even if this pain is severe or excruciating. We     predict that VR is feasible in this setting and that VR distraction will reduce acute pain     and anxiety during labor.   "
27449|NCT02926456|"     The purpose of this study is to describe the effectiveness of darunavir/cobicistat     (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after     baseline, defined as the day when the treatment with DRV/c-based regimen is started, through     collection of daily practice data in the Italian setting.   "
27450|NCT02926443|"     The shoulder is the most mobile joint in the body but still has the responsibility of     ensuring a strong stability of our upper limbs during daily activities. The shoulder joint     therefore requires a significant level of neuromuscular control at all times. The shoulder     heavily relies on 4 key stabilizing muscles, known as the rotator cuff complex (RC). A     tendinopathy of the RC may cause pain, significant muscle weakness, and a decrease in motor     control of the shoulder during functional activities as well as work tasks. Individuals who     have an RC tendinopathy often have neuromuscular and proprioceptive deficits. The objectives     of this study are to evaluate the effectiveness of a brand new strength and motor control     exercise program for the upper extremities and to compare the effectiveness of this program     to usual physiotherapy care (such as manual therapy, motion exercises, strengthening, manual     techniques) in reducing shoulder pain and improving overall function. A total of 44     participants suffering from an RC tendinopathy will be recruited; 22 will be assigned to the     exercise group (EXP) and 22 participants will be receiving usual physiotherapy care (CTL).     Participants in the EXP group will partake in the new exercise program 3 times / week for 6     weeks whereas participants in the CTL group will receive usual physiotherapy treatments twice     / week with home exercises for 6 weeks. The results of this study will provide clinicians     with a cost-effective and innovative treatment approach to treating shoulder pain. This study     will provide active rehabilitation guidelines for reducing shoulder pain and the incidence of     recurrence.   "
27451|NCT02926430|"     The purpose of this study is to assess the safety and tolerability of 2 single doses of     either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered     intramuscularly to elderly adults given at least 12 months apart.   "
27452|NCT02926417|"     The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients     undergoing major surgery. The investigators will identify then correlate soluble biomarkers     in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.   "
27453|NCT02926404|"     Retro-prospective study allowing inclusion of patients with spinal deformities treated by     patient-specific rods (UNiD).      This study aims to assess performance, clinical outcomes and safety   "
27454|NCT02926391|"     Multicenter study allowing to include the first sixty patients implanted with a custom-made     corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients     implanted in thoracolumbar region.      The main objective is to confirm feasibilty and safety of patient-specific implants for one     or multi-level corpectomy and fusion.      This study was approved in March 2016 allowing to include retrospectivley all patients since     the first implantation in January 2015 and prospectively all patients after the approval.   "
27462|NCT02926287|"     Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ     prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.      Secondary objectives are AS rate in the overall population and reasons for ineligibility or     failure of ambulatory surgery.      This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.      A randomized control study will follow PCAP study.   "
27478|NCT02926079|"     This proposed study; Investigation of mechanisms for transmission of impaired glucose     metabolism in infants exposed to diabetes in utero, will test the overarching hypothesis that     impaired maternal substrate oxidation (metabolic inflexibility) and placental lipotoxicity     are characteristics of diabetic pregnancies and in utero development within these conditions     programs a metabolically inflexible phenotype in the offspring.   "
27479|NCT02926066|"     This clinical trial expansion is to offer patients, who are not enrolled into the Phase I/II     trial, a chance of treatment, to extend the experience in this gene therapy, and to increase     the dosage slightly to waive the drug dilution procedure.   "
27463|NCT02926274|"     Massive hemorrhage is a major cause of potentially preventable death following trauma. A     common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading     to death from exsanguination. Even when bleeding is controlled, patients are at increased     risk of complications and mortality. Reconstituted whole blood, or component therapy with     packed red blood cells (PRBCs), plasma, and platelets was introduced by the military in     recent conflicts in Iraq and Afghanistan with remarkable results and has been adopted by most     civilian trauma centers. Despite improving coagulopathy, it is apparent that transfusion of     blood components is not equivalent to whole blood transfusion. Transfusion of high plasma     volumes may be associated with increased risk of allergic reaction, transfusion associated     acute lung injury (TRALI), hypervolemic cardiac failure, and acute respiratory distress     syndrome (ARDS). Military services have recently reintroduced fresh whole blood (FWB) for     standard resuscitation of massive hemorrhage, have found that FWB offers a survival advantage     over component therapy, and that risks of transfusion reactions are similar for FWB and     PRBCs. On the civilian side, whole blood is an FDA-licensed product that has been in use in     pediatric open heart surgery and autologous blood donation but is no longer commonly     available for other indications. However, the military results are renewing interest in whole     blood for trauma resuscitation. The use of low-antibody titer whole blood leukoreduced with a     platelet-sparing filter was recently approved by the University of California Los Angeles     Blood and Blood Derivatives Committee and two other trauma centers for male trauma patients.     This study will test the feasibility of providing FWB for resuscitation of patients in     hemorrhagic shock and determine the effects of FWB on clinical outcomes as well as the     effects on coagulation, fibrinolysis, and inflammation, compared to standard blood component     therapy.   "
27464|NCT02926261|"     Nutritional status in patients with cirrhosis has been shown to have a direct influence on     the prognosis of these patients, it is related to higher mortality and it has been linked to     the developement and perpetuation of certain complications such as hepatic encephalopathy,     ascites and spontaneous bacterial peritonitis.      Despite the importance of nutritional status in this patients, most of the methods for its     assessment are still not completely reliable or not easily accessible; therefore, evaluating     nutritional status in the daily clinical practice is still a complex task.   "
27465|NCT02926248|"     The specific aim of this study is to evaluate the effect of oral colchicine in primary TKA     patients at 3 months following a manipulation under anesthesia.   "
27466|NCT02926235|"     The goal of this trial is to assess the efficacy of essential amino acids (EAA) on muscle     atrophy and malnutrition compared to a placebo in patients following a total knee     arthroplasty. The investigators specific objectives included analysis of (1) muscle strength,     (2) change in malnutrition, (3) perioperative complications (4) physical activity.   "
27467|NCT02926222|"     This study aims to evaluate the role of Regorafenib in prolonging the overall survival of     glioblastoma multiforme patients who progressed after surgery and Stupp regimen with or     without bevacizumab.   "
27468|NCT02926209|"     This will be a prospective multi-center, multi-national comparative non-blinded clinical     investigation. Each subject will undergo back-to-back tandem colonoscopies with the     Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem     colonoscopy study, each subject will serve as their own control. The 1st procedure will be     randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The     same investigator will perform both procedures on each subject. All pathologies found will be     either removed or tattooed. Unmarked pathologies found on second pass will represent those     missed during the 1st pass, thus making the subject and the control one and the same.     Tattooed pathologies that can be removed endoscopically will be removed in an additional     colonoscopy. This may occur if a large polyp cannot be removed for any reason with the     Aer-O-Scope, but can be removed with conventional colonoscopy.   "
27469|NCT02926196|"     Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or     post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall     protocol-defined patient population will include the following two strata of patients:        -  Stratum A - Patients who have completed treatment with curative intent including surgery          of the primary tumor followed by adjuvant chemotherapy and (if indicated) radiotherapy.        -  Stratum B - Patients who have completed treatment with curative intent including          neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated)          radiotherapy.   "
27470|NCT02926183|"     Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international     oncology meeting and represents a new standard regimen in the treatment of metastatic     pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy     on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen     includes only two cycles (three times weekly and one week rest) of GA regimen.   "
27471|NCT02926170|"     Long-term anticoagulation is widely used for secondary thromboprophylaxis in the     antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently     anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have     unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment.     Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and     safe compared with warfarin for the treatment of venous thromboembolism and non valvular     atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study     is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis     in patients with APS compared with acenocumarol   "
27472|NCT02926157|"     The purpose of this study is to investigate whether a comprehensive group education combined     with a lifestyle activation program that includes (a) sleep hygiene course, (b) physical     activity promotion, and (c) bright light therapy, can improve both sleep quality and     cognitive function among 96 community-dwelling older adults.   "
27473|NCT02926144|"     The main objective of this study is to compare the proportion of tracheal intubations for     which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.   "
27474|NCT02926131|"     This is an observational prospective study. The main purpose is to evaluate the stability of     the Bilistick system in a humid and hot climate compared to the quantitative test for serum     bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a     controlled environment.      The secondary aim is to assess the operational feasibility of the Bilistick system in a     tropical limited-resource setting, when used by locally trained nurses.   "
27490|NCT02925923|"     The purpose of this study is to compare the inhibition of platelet aggregation (i) ticagrelor     and bivalirudin/heparin versus (ii) clopidogrel, eptifibatide and heparin in patients with     unstable angina undergoing coronary intervention.   "
27491|NCT02925910|"     Two groups of randomised rehabilitation patients will try a softwheels wheelchair and a     regular one. One group will start with the softwheelsl and then change to the regular, and     the other will start with the regular and then change to the softwheel.   "
27480|NCT02926053|"     Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved     impressive clinical results with durable complete responses in patients with metastatic     melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion     and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion     Interleukin-2 is administered to support T cell activation and proliferation in vivo.      Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,     including Renal Cell Carcinoma. In this study TIL therapy is administered to patients with     metastatic Renal Cell Carcinoma.   "
27481|NCT02926040|"     A. Pancreatic cancer background In 2012, 1,172 new pancreatic cancer patients were diagnosed     in Switzerland. Only 20% of the patients with newly diagnosed pancreatic cancer are     candidates for surgical resection, the only potential treatment for cure. Over 30% of the     patients initially present with locally advanced disease. Patients with locally advanced     disease have no evidence of metastatic spread to the liver, lung, and peritoneum but present     with local involvement of vital structures that prohibits reasonable tumor resection.     Currently, those patients are evaluated for palliative chemotherapy +/- radiation therapy.     However, even with best conventional medical therapy, median survival of patients with     locally advanced disease is mostly below 1 year. Over the last years, loco-regional therapies     gained increased attention including radiofrequency-, cryo-, and microwave ablation as well     as electrochemotherapy. However, all those entities are criticized by their complication     rates leading to morbidity and mortality, limited area of application given the complex     anatomical structures around the pancreas, and ill-defined improvements in overall survival.      B. Irreversible electroporation (IRE):      Irreversible electroporation is an emerging ablative modality that gained enormous interest     over the last five years. For locally advanced pancreatic cancer, it was introduced in 2009.     IRE is mainly non-thermal and primarily works through apoptosis. Its well studied safety     profile allows ablation also within the context of locally advanced pancreatic cancer given     it mainly spares vessels from destruction.      Increasing evidence shows that IRE for locally advanced, unresectable pancreatic cancer is     effective compared to historic controls with a significant prolongation of local progression     free survival, distant progression free survival and overall survival. The improvement in     overall survival is about double the amount of what is seen with best new chemotherapy and     chemoradiation regimens used at the present time. Those results are even more impressive     given the discouraging improvements among palliative systemic options.      The NanoKnife IRE device (Angiodynamics, Queensbury, NY) is commonly used to perform IRE     procedures in pancreatic cancer patients and is commercially available since 2009 and got     Food and Drug Administration (FDA) 510K clearance for soft tissue ablation in October 2011 in     the United States.      C. Quality of life and nutritional status/long term outcomes Given the overall poor long-term     outcomes of patients with pancreatic cancer, health-related quality of life (HRQoL) measures     are of utmost importance when treatment recommendations are discussed with patients. This is     especially true for patients with more advanced staged disease where definitive surgical     resection with curative intent is not possible. However, HRQoL reports for patients with     locally advanced pancreatic cancer undergoing IRE are very limited. To the best of the     investigators' knowledge, no other specific investigations exist that assessed HRQoL measures     for patients undergoing IRE for locally advanced pancreatic cancer, no specific assessment     exists that focuses on nutritional status for this patient group. In addition, impact on     local and distant recurrence as well as cancer-specific and overall survival are still     ill-defined and further information is needed.   "
27482|NCT02926027|"     Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated     Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of low     attenuation plaque under influence of Vascepa as compared to placebo.   "
27483|NCT02926014|"     The aim of this research was to evaluate the lingual tonsil hypertrophy (LTH) grading of     patients with dysphagia using videolaryngoscopy and determine the relation of LTH grades to     sociodemographic factors and clinical symptoms.   "
27484|NCT02926001|"     The purpose of this study is to evaluate formally the short term impacts of the tax policy     applied to Sugar-Sweetened Beverages (SSBs) in Chile. The Impuesto Adicional a las Bebidas     Analcohólicas (IABA, or additional tax on soft drinks) in Chile was enacted in October     2014, affecting any non-alcoholic beverages to which colorants, flavourings or sweeteners     have been added. For beverages above an added sugar concentration of at least 6.25 grams per     100ml (or equivalent proportion), the tax was increased from 13% to 18%, while for those     below this threshold the tax was decreased to 10%, producing an 8% tax difference between     these beverage groups. This impact evaluation analysis of the Chilean sugar-sweetened     beverage (SSB) tax will estimate the impact of increasing the tax as well as decreasing the     tax on soft drinks. The study will use household level grocery purchasing data for Chile. The     purchasing records are available from October 2011 to September 2015 (three years before; and     one year after the implementation of the tax in October 2014). The investigators will use a     series of quasi-experimental approaches to evaluate the causal impact of the SSB tax policy     on consumers' behaviour as well as on industry responses in the form of pricing and price     promotion decisions.   "
27485|NCT02925988|"     Over the past decade, technical advances have improved the efficiency of continuous EEG     recording and remote review, leading to a steep increase in the number of continuous EEGs     performed, and to an emerging change in what is considered the standard of care with regards     to brain monitoring. Critically ill patients are at high risk for CNS insults, which can     result in permanent neurologic disability if untreated. Non-convulsive status epilepticus and     other secondary brain injuries are often unrecognized without continuous EEG monitoring.     There is increasing evidence that continuous EEG monitoring facilitates early identification     and management of changes in brain function, and a recent consensus statement concludes that     each center should provide critical care continuous EEG at the highest level that local     resources allow. Neonatal neuro-intensive care is a rapidly developing field with a focus on     monitoring of the developing brain. Without continuous EEG monitoring, neonates with     paroxysmal events that are suspicious for seizures are treated with phenobarbital, often for     many months, with inherent risks of side effects. Because paroxysmal events in neonates may     or may not represent seizures, and electrographic seizures may have no discernable clinical     correlate, this approach fails to adequately diagnose seizures and exposes neonates to     possible harm, either by medication overuse for paroxysmal events that have no electrographic     correlate, or by under-treatment of seizures without clinical manifestations.     Amplitude-integrated EEG technology is now increasingly used as a simplified monitoring     method, using fewer numbers of electrodes and usually being interpreted by a neonatologist or     trainee. This model has been implemented at the investigators NICU. However, a recent     systematic review came to the conclusion that amplitude-integrated EEG has relatively low and     variable sensitivity and specificity, and therefore should not be the mainstay for diagnosis     and management of neonatal seizures. Continuous video EEG monitoring is recommended as the     gold standard for critically ill neonates, but is a very expensive and resource-intense     method. An approach combining both techniques in a standardized algorithm may provide     improved patient care in a resource-restricted environment. The investigators are planning to     test this hypothesis in a pilot project.   "
27486|NCT02925975|"     The aim of this study is to investigate the possibilities of early and precise management to     decrease portal vein pressure in cirrhotic patients, guided by a non-invasive     3D-virtual-model of hepatic portal system (3D-vHPS). Healthy volunteers are enrolled to     determine the normal range of pressure density in different sites of HPS. Cirrhotic patients     without visible gastro-esophageal varies by endoscopy are randomly enrolled to virtual portal     vein pressure gradient (vPVPG) monitored or non-vPVPG monitored groups. Non-vPVPG groups are     followed-up and treated according to Baveno V consensus in portal hypertension. Patients in     vPVPG-monitored groups are followed-up by anatomic computed tomographic angiography (CTA) and     Doppler ultrasound every six months. Once vPVPG is above 12mmHg, participants will receive     carvedilol treatment. All cirrhotic patients are followed-up with the incidence of portal     hypertension-related complications, mortality rate and life quality assessment.   "
27521|NCT02925507|"     It is the purpose of this study to determine if a commercially available electronic     stethoscope synchronized with an smart phone or iPad application can be used as an accurate     and objective screening tool for measuring dysphagia. The investigators plan to do so in two     phases; in Phase I the investigators will recruit normal subjects to establish normal     swallowing patterns, as well as optimal sensor placement; and in Phase II the investigators     will compare the recordings obtained by the electronic stethoscope with those obtained using     videofluoroscopy.   "
27487|NCT02925962|"     The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in     primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or     one of two intervention arms. The first intervention will evaluate the efficacy of an     automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker     test ordering, guideline implementation and BP management, compared with usual care, among     patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention     goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a     pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge     among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP     level, with secondary outcomes related to processes of care and patient knowledge.   "
27488|NCT02925949|"     This is a randomized controlled trial of a new behavioral intervention designed to improve     engagement in HIV care for same-sex male couples. Investigators will compare the HIV viral     load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to     an individual adherence intervention (LifeSteps).   "
27489|NCT02925936|"     Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the     position of the anode and cathode.   "
27492|NCT02925897|"     The prevalence of people living with problems due to a long-term condition (LTC) such as     heart disease, diabetes or arthritis in England exceeds 15 million, and the number of those     with more than one LTC continues to grow (LTCs). This population consumes a large proportion     of health service resources. Advancing age and LTCs increase the likelihood of becoming     housebound, this has a detrimental effect on health and quality of life. Health policy     advocates a health service model of empowerment and self-care. People who live with LTCs are     often very knowledgeable about how to look after their health but find it difficult to adjust     their.      Motivational techniques have been demonstrated to facilitate behaviour change through     changing the style of communication from directive to collaborative. The use of     patient-centred conversational style of communication has been shown to elicit more     willingness to change than professional-led directive consultations. Community nurses are in     a unique position to influence housebound patients to play a greater part in caring for     themselves, preventing complications in their long-term conditions and further ill health.      This study intends to test the feasibility and acceptability of training community nurses in     Understanding Behaviour Change, a communication technique which uses motivational     interviewing to guide patients to change their behaviour. The opportunistic use of     motivational techniques to create participatory relationships between patients, community     nurses potentially represents an effective intervention to enable patients with LTCs to     optimise the way they care for themselves.      Motivational interviewing techniques have been widely demonstrated to bring about behaviour     change but have not been studied in the context of changing the style of communication     between housebound patients and the professionals caring for them.   "
27493|NCT02925884|"     The proposed study aims to test if Gunnar computer glasses provide any advantages, in     comparison to no glasses, on the following aspects in computer-related office work:        -  Any enhancement on visual performance of basic visual function, including visual acuity,          contrast sensitivity, color discrimination, etc.        -  Any enhancement on visual performance of typical office work, including reading,          word-spelling check, number searching, or target identification.        -  Any benefit in objective viewing comfort measured with viewing distance, blink          frequency, post-viewing pupil size.        -  Any benefit in subjective viewing comfort reflected on the questionnaire of viewing          symptom survey.        -  Any benefit in viewing comfort and visual performance with increased environmental          ventilation or under strong glare.        -  Any benefit in life quality from daily wearing (e.g., better comfort or sleep quality).   "
27494|NCT02925871|"     There is strong evidence that early supported discharge and continued rehabilitation at home     (ESD) delivered by an interdisciplinary team reduces deaths or dependency in activities in     daily living after stroke. Despite recommendations in national guidelines ESD is only     implemented in few places in Sweden. There are interdisciplinary teams that supply     rehabilitation in the home but the coordinated transition is lacking. Such rehabilitation is     not evidence based. The key components of a coordinated transition to achieve the benefits of     ESD are not known. The aim is to design, implement and evaluate new person-centred     transitions between stroke units and the home to achieve full ESD. The development of     person-centred transition will be performed together by people with stroke, significant     others, stroke unit staff and interdisciplinary teams.      Phase 1, a prospective observational study of current transitions from stroke units to     rehabilitation in the home without coordination. The aim is to identify factors that are     facilitators or barriers to transitions, patient and caregiver outcomes, use of health care     during the first year after stroke. In phase 2, a co-design process of new person-centred     transitions will be carried out by people with stroke, significant others, stroke unit staff     and interdisciplinary home rehabilitation teams. In phase 3 new person-centred transitions     will be implemented to form a full ESD service and evaluated in a cluster randomised     controlled trial.   "
27495|NCT02925858|"     Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative     infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in     coronary artery bypass surgery patients receiving a median sternotomy.   "
27496|NCT02925845|"     -  Objective: To analyze the effect of neuromuscular electrostimulation in the maturation          of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease          (CKD) stage 5-5D        -  Design: Clinical Trial with medical devices, 18-month, single-center, within the          hospital setting.        -  Disease or disorder study: vascular Access maturation.        -  Population: Patients with CKD stage 5-5D at the research center.        -  Project duration: 78 weeks        -  Methodology:        -  Patients with CKD stages 5-5D that has undergone a native AV in service stations to give          their informed consent and meeting the inclusion criteria will be included.        -  At baseline two study groups were established:             -  Group 1: neuromuscular electrostimulation             -  Group 2: isometric exercises   "
27497|NCT02925832|"     Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract     surgeries by phacoemulsification. In this study the investigators intend to compare     ropivacaine and bupivacaine in various parameters during phacoemulsification.   "
27498|NCT02925819|"     The objective of this study is to collect in a prospective registry all cases of French     patients undergoing an assessment for percutaneous treatment of mitral valve disease on a     native valve or due to deterioration after surgical valve repair or replacement. In these     patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This     registry will evaluate the morbidity and mortality up to 24 months for those patients with     severe mitral valve disease who are not included in a clinical trial. The association of     demographic, clinical, laboratory, echocardiographic variables and treatment options with     morbidity and mortality will be evaluated by univariate and multivariate analyses.   "
27499|NCT02925806|"     A drug utilization study will be performed to describe trends in the number of prescriptions     and patients for class REMS ER/LA opioids and comparator products.   "
27500|NCT02925793|"     The purpose of this randomized, double blind, placebo controlled, parallel group study is to     compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle     cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis.   "
27501|NCT02925780|"     Clinical trial to investigate the clinical efficiency of resin infiltration technique for the     improvement of dental fluorosis.   "
27502|NCT02925767|"     A randomized controlled non-inferiority trial based on split-body was planned to compare the     efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.   "
27514|NCT02925598|"     The standard procedure used for airway control in general anesthesia for LC (laparoscopic     cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway     devices (SADs) used for airway control for certain types of surgeries. The aim of this study     was to evaluate and compare the performances of new types of SADs with EI regarding their     insertion times, durations, perioperative complications and effects on hemodynamic parameters     and peak airway pressures (Paw) in LC as well.   "
27503|NCT02925754|"     Pain catastrophizing is conceptualized as a negative cognitive-affective response to     anticipated or actual pain and has been associated with a number of important pain-related     outcomes.      The aims of this study are        1. To describe the characteristics of the patients and determinants of catastrophizing in          chronic painful patients hospitalized in rheumatology in the Nîmes University Hospital        2. To describe the impact of the catastrophizing on the level of insomnia and the drugs          consumption in chronic painful patients hospitalized in rheumatology in the Nîmes          University Hospital   "
27504|NCT02925741|"     This study will use a traditional cluster randomized crossover design with patients in five     medical intensive care units at the Cleveland Clinic to evaluate the efficacy of silk-like     bed sheets and underpads for prevention of Unit-Acquired Pressure Ulcers (UAPU). Adult     hospitalized patients in beds with standard bed linens versus those with silk-like linens     will be compared for 1) rate of development of UAPU, 2) time to develop the first UAPU, and     the maximum severity of any UAPU that develop. Bed linens will be changed per unit protocol.     Patient characteristics will be summarized using frequencies and percentages for categorical     factors and means, standard deviations, percentiles and median and range for continuous     measures. For the primary outcome of unit-acquired pressure ulcer rate, generalized linear     mixed models, assuming a Poisson distribution for the outcome, and unit length of stay as an     offset will be used. For the time to event analysis, frailty models will be used to assess     whether time to first pressure ulcer differs between treatment types. Generalized linear     mixed models will be used for other secondary endpoints, including maximum severity of     observed pressure ulcers   "
27505|NCT02925728|"     The undernourishment and the prevention of its risk at the elderly person in seniors's     resident represent a major issue in public health. The diagnosis of undernourishment and its     risk are systematically recommended in these structures where the nutrition of these people     is a problem because often inappropriate for their capacities of prehension and consequently     for their nutritional needs. One of the solutions to remedy can be found in the  finger-food     .      The study FIFO (Finger-Food) suggests verifying the hypothesis which the finger-food would     allow to increase the nutritional intake of the resident who have disorders of the prehension     and\or requiring a nutritional stimulation and\or require an help to the preparation of the     meal.   "
27506|NCT02925715|"     Comparison of two techniques of central venous cannulation of subclavian vein using     ultrasound was performed. ultrasound guided central venous cannulation is the standard     practice today but its use in subclavian vein is technically challenging and not much     literature is available. In this study 96 Patients were randomized into one of the groups and     compared for various outcomes. The primary outcome studied was the time taken for procedure.     Secondary objectives included comparison of total access time using both the     techniques,comparison of first attempt success rate, comparison of the quality of needle     visualization and the comparison of immediate (mechanical) and delayed complication rates.   "
27507|NCT02925702|"     Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer     Treated With Radium 223   "
27508|NCT02925676|"     To evaluate the technical performance of the hyposafe H02 during everyday activities and     during insulin-induced hypoglycaemia, in addition to safety issues associated with the     implantation and use of the hyposafe H02 in subjects with type 1 diabetes.   "
27509|NCT02925663|"     The purpose of this study is to establish the feasibility, accessibility, acceptability, and     preliminary efficacy of an individually-tailored intervention to improve EF in adolescents     with epilepsy (EFI-E).   "
27510|NCT02925650|"     This study evaluates the safety and pharmacological effects of 3 different doses of Posiphen®     when compared to a placebo, in adult male and female patients with early Alzheimer's disease     (AD).   "
27511|NCT02925637|"     To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT)     in occupational therapy for people after mild to moderate stroke.   "
27522|NCT02925494|"     This is an extension study for women who have already received six months of treatment in the     phase III clinical trial M12-815 or M12-817, and will evaluate the long-term efficacy and     safety of elagolix administered alone and in combination with estradiol/norethindrone acetate     for an additional six months in the treatment of heavy menstrual bleeding associated with     uterine fibroids.   "
27564|NCT02924948|"     Endoscopic ultrasonography (EUS) is an essential technique required in diagnosis of     pancreatobiliary diseases. In previous studies, 6% of patients who undergone EUS had     significant throat pain. (NRS scale 5 or greater) Although some endoscopists think balloon     inflation while EUS insertion could result in decreased throat damage and pain, there is no     data to back up. We designed a single center randomized pilot study to compare throat pain     caused by EUS insertion with conventional vs balloon inflation method.   "
27512|NCT02925624|"     Title: CLOSE-guided pulmonary vein isolation (PVI) as Cure for Paroxysmal Atrial Fibrillation     ('CLOSE to CURE' study)      Design: This is a prospective, observational, single-center, unblinded, clinical 3-year     study.      Background: In a population of paroxysmal atrial fibrillation (AF) 'CLOSE'-guided PVI, a new     approach to obtain single-procedure durable PVI, has been shown to virtually eliminate     recurrence of AF at 1 year follow-up with repetitive but discontinuous Holter monitoring.      Objectives: (1) To objectively compare atrial tachyarrhythmia (ATA) burden before and after     'CLOSE'-guided based PVI using continuous monitoring. (2) To assess ATA burden using     continuous monitoring up to 3 years after ablation. (3) To identify baseline structural and     electrical properties of the atria or procedural characteristics that predict 1-year and     3-year outcome.      Enrollment: Up to 100 subjects will be enrolled in this observational, prospective study.      Clinical Sites: 1 site.      Subject Population: Eligible patients are patients with paroxysmal high-burden AF who are     planned for a 'CLOSE'-guided PV isolation. At the time of procedural planning we will ask the     patient his/her consent for (1) implantation of a subcutaneous continuous loop recorder     (sCLR), (2) a concise electrophysiological study at the time of PVI, (3) a transthoracic     echocardiogram at the time of PVI and (4) collection of data during 3 years. Anti-arrhythmic     drug treatment (ADT) and oral anticoagulation (OAC) will be given according the updated 2012     European society of Cardiology (ESC) guidelines on AF (Camm et al, European Heart Journal     2012) and the 2012 Heart rhythm society (HRS)/European Heart Rhythm association/European     cardiac arrhythmic society Expert Consensus Statement on catheter and surgical ablation of     atrial fibrillation (Calkins et al, Heart Rhythm 2012).   "
27513|NCT02925611|"     Postoperative delirium (POD) is a known complication of inhalational agents used to     anaesthetise patients for surgery with potential long term implications.The incidence of     postoperative delirium in spine surgery is 3.3% to 3.8%.The purpose of this study is to     compare the occurrence of postoperative delirium with inhalational anaesthetics namely     isoflurane and desflurane in spine surgery patients.   "
27516|NCT02925572|"     Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle which permits     eccentric (ECC) lower limbs contractions at a defined power output. With this type of     ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the     same power output. Consequently, ECC program could be used in chronic disorders with limited     capacities, such as obesity.      The investigators hypothesis that an eccentric training program, as it will induce higher     mechanical constraints, would improve body composition, especially by reducing fat mass. This     effect could be explained by an increased rest energy expenditure and a better improvement in     biological parameters (particularly lipid profile and insulin-resistance) after ECC training     (versus CON training).      This study aims to compare the modification of fat mass after an ECC program versus a CON     program at the same VO2.. The secondary goal is to assess the physiological mechanisms     involved in the modification of body composition.   "
27517|NCT02925559|"     Objectives      Primary objective:      To access the change from baseline to week 12 in MAGE index of glycemic variability measured     by CGMS for dapagliflozin versus. gliclazide MR.      Secondary objectives:        1. Change from baseline to week 12 in glycated hemoglobin A1c (HbA1c), fasting plasma          glucose, postprandial glucose and achievement of HbA1c ≤6.5% and <7% at the end of the          study) for dapagliflozin versus gliclazide MR.        2. Change from baseline to week 12 in glycemic variability defined by the interquartile          range (IQR - interval between 25th and 75th percentiles) measured by CGMS for          dapagliflozin versus gliclazide MR.        3. Change from baseline to week 12 in glycemic variability measured by the Standard          Deviation of the mean glycemia (SD) measured by CGMS for dapagliflozin versus gliclazide          MR.        4. Change from baseline to week 12 in glycemic variability measured by the Coefficient of          Variation (CV) measured by CGMS for dapagliflozin versus gliclazide MR.        5. Change from baseline to week 12 in the time spent on hypoglycemic range (glycemia          <70mg/dL) measured by CGMS for dapagliflozin versus gliclazide MR.      Study design This is a single-center, prospective, randomized, open-label, comparative, phase     IV study to compare the effects of gliclazide MR and dapagliflozin on Glycemic Variability in     patients with Type 2 Diabetes Mellitus (T2DM). All patients should be treatment naïve or     receive standard of care therapy for T2DM as well as for co-morbidities based on accepted     guidelines and local best practices.      Target patient population Approximately 120 patients with T2DM will be randomized from study     site. Patients who were treated with metformin only and had inadequate glycemic control at     the time of enrollment as well as treatment naïve or non-medically treated (e.g., diet)     patients, will be enrolled and receive either dapagliflozin 10mg qd or comparator gliclazide     MR 120mg qd in addition to standard of care treatment for T2DM and co-morbidities.      Investigational product, dosage and mode of administration Dapagliflozin 10mg tablets     administered orally once daily for 12 weeks.      Comparator, dosage and mode of administration Gliclazide MR 60mg tablets administered orally,     2 tablets once daily for 12 weeks.      Duration of treatment The treatment with study medication or comparator will have a total     duration of 15 weeks.   "
27518|NCT02925546|"     GSK2798745 is being developed as a novel therapeutic intervention for the treatment of     pulmonary edema associated with heart failure (HF) and is currently under investigation in     the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover     study with the purpose to determine the pharmacokinetics (PK) of three 2.4 milligrams (mg)     tablet formulations of GSK2798745 in 12 healthy subjects. The three formulations developed     for this study will be micronized GSK2798745 active pharmaceutical ingredient (API) (Tablet     A), micronized GSK2798745 API with sodium lauryl sulfate (SLS) and hypromellose (Tablet B),     milled GSK2798745 API with SLS and hypermellose (Tablet C), and Tablet D, which will be     either A/B/C based on interim PK analysis of data from the first three treatment periods.      Following a 30-day screening period, subjects will be randomized to one of the 6 treatment     sequences: Treatment sequence 1: ABCD, 2=CABD, 3=ACBD, 4=BACD, 5=BCAD, 6=CBAD over three     4-day treatment periods. For treatment period 4, the best formulation based on the interim     analysis data from the three treatment periods will be evaluated under fed conditions. Each     treatment period will be separated by a minimum of 7 (+14)-day washout period. The total     duration of participation in the study will be approximately 11 weeks including the follow-up     visit.   "
27519|NCT02925533|"     This research study is studying a combination of two experimental drugs as a possible     treatment for Bladder Cancer that recurred after treatment with standard therapy, or Bladder     Cancer that got worse while on treatment with standard therapy.      The following interventions will be involved in this study:        -  B-701        -  Pembrolizumab   "
27520|NCT02925520|"     This is an expanded access study to assess the safety profile and changes in serum direct     bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive     therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven     will be infused intravenously through either a central or peripheral catheter in conjunction     with parenteral nutrition. The same standards of care provided to all patients receiving     parenteral nutrition solution will be followed.   "
29127|NCT02904395|"     Given the 100 fold increase of the incidence of Pompe's disease in Western French Guiana, the     objective of the present study is to implement systematic screening in newborns in French     Guiana in order to start treatment before the muscular and cardiac symptoms appear.   "
27523|NCT02925481|"     Each year more than 26,000 pregnancies in the United States end in stillbirth (late fetal     death at >20 weeks of gestation). A 2011 issue of the Lancet, dedicated entirely to     stillbirth, recognized it as a too-often-ignored public health problem despite occurring     once in every 160 pregnancies. The death of a baby is highly traumatic and can incite     negative mental, emotional, and physical health consequences lasting years after the loss.     Bereaved mothers with stillbirth have a 4-fold higher risk of depression and 6-fold higher     risk for post-traumatic stress disorder (PTSD). These mental health consequences are likely     to negatively affect subsequent pregnancies, many of which occur within the first year after     loss (50-98%).      Inter-conception care is provided to women of reproductive age between pregnancies; however,     few interventions focus on PTSD symptomatology and its related comorbidities in bereaved     mothers. Treatment for bereaved mothers may include psychiatric medication and/or referral to     support groups. Because bereaved mothers with stillbirth may have additional mental and     physical health risks, pharmacological interventions are typically a first and sole line of     treatment and may not sufficiently allay bereaved mothers' emotional distress. Moreover,     women may be trying to conceive or may have already conceived and report reticence to taking     medication. Additionally, support groups with little emphasis on coping may not be helpful     for some grieving mothers.      Non-pharmacological approaches, such as yoga, may be an alternative option for bereaved women     with stillbirth. Yoga has been established as an effective, safe, acceptable, and cost     effective approach to improving mental health in a variety of populations, including pregnant     and post-partum women. Yoga has also been used as a means to cope with PTSD associated with     surviving a traumatic event (i.e., interpersonal violence, military veterans). We are unaware     of any studies that have explored yoga to reduce PTSD in bereaved mothers with stillbirth.     Furthermore, online streaming yoga (on-demand videos played in the home) has recently grown     in popularity and may address the unique barriers that women experiencing stillbirth may     have. To reduce PTSD symptoms and its co-morbid conditions (i.e., anxiety and depression) we     propose to develop and test the feasibility and acceptability of a home-based, online     streamed yoga intervention (www.udaya.com) for bereaved mothers with stillbirth.   "
27524|NCT02925468|"     The correction of a deep overbite is assumed to involve incisor intrusion and the extrusion     or eruption of premolars and molars. The latter is also assumed to be the major contributor     for growing patients where the vertical facial growth increase accommodates for the     additional eruption of posterior teeth with anterior bite plane appliances.      In this study the nature and rate of adaptation of the occlusal changes following insertion     of a fixed anterior bite plane for the reduction of a deep overbite in growing patients will     be investigated.   "
27602|NCT02924441|"     To determine in a randomized trial whether it is possible to decrease the discomfort and     anxiety of mammography by using the local analgesic lidocaine, or by using calming music in     patients receiving a mammogram.   "
27525|NCT02925455|"     This is a pilot randomized controlled trial of an intervention to improve arm function in     children ages 6 to 17 with cerebral palsy and upper limb hemiparesis. Twenty participants     will be randomized to either a group treated with neuromuscular electrical stimulation and     video games or video games alone. Both groups will receive 6 wks of treatment consisting of     home and lab sessions. Both the experiment group and control group interventions consist of     therapist-guided sessions in the rehabilitation clinic and self-administered or     caregiver-assisted sessions at home. While both groups will receive the same task practice     and video game training, only the experiment group will receive an electrical stimulation     device to assist with hand opening during practice. Changes in upper extremity motor     impairment and function will be assessed for each participant at baseline, mid treatment, end     of treatment and at 3 mo follow-up.   "
27526|NCT02925442|"     Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is     the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard     genicular radiofrequency ablation (t-RFA) has been effective pain management for     non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency     ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer     minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study     will perform a double-blinded, parallel grouped, placebo-controlled randomized study to     compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and     control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered     preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative     pain relief.   "
27527|NCT02925429|"     PostNAPs was a continuation of the PreNAPs study. 246 women were enrolled in the postnatal     period with the primary scientific objective of determining whether food insecurity was an     independent risk factor for poor maternal nutritional or psychosocial outcomes or for     sub-optimal infant feeding practices.   "
27528|NCT02925416|"     The purpose of this study is to evaluate the safety and tolerability of two 1200-mg IV     infusions of oritavancin when administered one week apart.   "
27529|NCT02925403|"     This is a study in which healthy adult volunteers will be given either an experimental     Malaria vaccine or a saline control vaccine.      Each volunteer will receive three vaccinations in total. Volunteers will be randomly     allocated to one of three groups:      Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will     receive a high dose of the Malaria vaccine on days 0, 28, and 56. Group 3 will receive a     saline solution on days 0, 28, and 56.   "
27530|NCT02925390|"     This study involves research, and the purpose of this study is to evaluate live birth rates     among couples who are treated by Natural procreative technology, (NPT) for infertility and     miscarriage.      Comparisons will be made to those declining NPT treatment, waiting for NPT treatment,     receiving other treatment, or stopping treatment. The investigator seeks to document specific     pregnancy rates for different factors such as age and type of infertility diagnosis.     Investigators will also assess characteristics of environmental exposures that may be     associated with infertility. Couples will be followed for up to three years, regardless of     when they begin NPT treatment, or whether they continue treatment. Data from all couples will     be useful for this study, regardless of their individual circumstances or actual treatment.   "
27531|NCT02925377|"     Female handball athletes are at a particular risk of sustaining lower extremity injuries. The     study examines time-dependent adaptations of static and dynamic balance as potential injury     risk factors to a specific warm-up program focusing on neuromuscular control.   "
27541|NCT02925247|"     Direct oral anticoagulants (DOAC), an inhibitor of factor IIa (dabigatran) or factor Xa     inhibitors (rivaroxaban, apixaban) are an alternative to treatment with warfarin in patients     with atrial fibrillation (AF) non-valvular .      These molecules have demonstrated non-inferiority compared to warfarin standard treatment for     the prevention of thromboembolic events in patients with non-valvular AF at high risk     thomboembolique (Score CHA2DS2-VASc ≥1). These molecules have a constant biological     effectiveness does not require laboratory monitoring in clinical practice, unlike AVK whose     use requires, because of their variability action intra- and inter-individual, a constant     dose adjustment based on 'Nationalized Index Ratio (INR).      The objective of this study is to evaluate the interest of specific dosage of anti-activated     factor X activity (Xa) in the identification of non-observing treating patients with Factor     Xa inhibitor in patients with non-FA valvular   "
27532|NCT02925364|"     The current study is an amendment to a previously approved blinded randomized controlled     trial (NCT02697812) which examines the rate at which the sternal retraction maneuver is     performed during cardiac surgery (standard over 30 seconds versus. gradual over 15 minutes)     and examines the incidence of chronic post-sternotomy pain 6 months following surgery.      Patients enrolled in the parent study will be identified at the 6 month follow-up and     recruited in terms of whether they report chest pain. A total of 30 participants will be     recruited (15 with and 15 with no pain) to undergo a single MRI session in which functional     MRI will be done on the brain stem and spinal cord and anatomical MRI images will be     collected for specific chest and neck structures. This will indicate whether there are     long-term differences in pain processing and/or physical damage to neck and chest structures     in those with and without chronic pain 6 months following coronary artery bypass graft     surgery. All functional and anatomical MRI images will be reviewed and interpreted with study     personnel blinded to whether the patient is reporting pain or no pain at their 6 month     follow-up interview.   "
27533|NCT02925351|"     This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography     (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory     diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by     inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to     measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan     may help to determine how fluorine F 18 clofarabine is distributed throughout the body.   "
27534|NCT02925338|"     National, prospective, multicentre observational study designed for eligible patients treated     with Inflectra.      Its objectives are to describe under real conditions of use, the profile of patients treated     with Inflectra and the response to treatment.   "
27535|NCT02925325|"     Residual Symptoms of Depression (SRD) are those symptoms that persist despite remission of     MDD. They are characterized by a high incidence (approx. 90% of patients in remission) at the     psychiatric clinic, have become a growing problem. Its presence is associated with a high     probability of relapse / recurrence and disability, as determined by decreased performance     and low quality of life. Their neglect has generated an increase in clinical and     socioeconomic costs, alerting the need for research to provide treatment strategies. The     application of different types of psychotherapy has been successful in abating SRD. The     present study aims to evaluate the clinical changes related to the application of music     therapy as a treatment of SRD, through a randomized controlled trial with two treatment arms     trial. Music Therapy (MT) is a psychotherapy provided by specialized health professionals,     and is defined as the clinical use of musical evidence-based interventions within a     therapeutic relationship. MT treatment group will design an application schema of 8 sessions     (2 hrs. Each) over a period of two months (one session per week). The control group will     receive the Usual Treatment (TU) which corresponds to the usual clinical psychiatric     treatment by the physician in the INPRF, with the same duration. The evaluation will be     conducted with clinimetric testing at baseline, at the end of the track and after three     months of treatment. This study seeks to identify the presence of SRD in a Mexican sample and     explore a treatment designed for that purpose, also, show that the MT is a cost-effective     implementation can become a new clinical option to extend the possibilities of assistance and     deepen the investigation of this problem.   "
27536|NCT02925312|"     The MedStar Diabetes Institute (MDI), in partnership with key MedStar Health system diabetes     stakeholders, seeks to implement an evidence-based innovative integrated care pathway for     MedStar patients with uncontrolled diabetes which will demonstrate improvement in diabetes     care outcomes.   "
27537|NCT02925299|"     The main study objective is to determine whether 24/7 automated closed-loop glucose control     combined with low glucose feature will improve glucose control as measured by HbA1c.      This is an open-label, multi-centre, multi-national, single-period, randomised, parallel     group design study, involving a 12 month period of home study during which day and night     glucose levels will be controlled either by a closed-loop system combined with low glucose     feature (intervention group) or by insulin pump therapy alone (control group).      It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with     type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the     investigation centres. Participants will all be on subcutaneous insulin pump therapy.      Subjects in the intervention group will have proven competencies both in the use of the study     insulin pump and the study continuous glucose monitoring (CGM) device, and will receive     appropriate training in the safe use of closed-loop insulin delivery system and low glucose     feature. All subjects will have regular contact with the study team during the home study     phase including 24/7 telephone support. The primary outcome is between group differences in     HbA1c levels at 12 months post study arm initiation. Secondary outcomes are the time spent in     the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above     and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation     comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic     ketoacidosis (DKA).   "
27538|NCT02925286|"     The purpose of this study is to determine the effects of a workplace prevention program     targeting problematic gambling.   "
27539|NCT02925273|"     The goal of this project is to determine the optimal technique to elicit the grasping     response in patients with dementia or suspected frontal lobe dysfunction. The proposed study     is to perform two techniques to elicit grasp response in patients with dementia or suspected     frontal lobe dysfunction and observe the presence or absence of the response and prominence     of the response on a proposed rating scale. Future goals will be aimed at aiding clinicians     in refining their clinical techniques to be more sensitive for diagnosing frontal lobe     dysfunctions.   "
27540|NCT02925260|"     A study to investigate the prevalence of pelvic collections in a representative sample of     participants with normally functioning ileal pouches. It also aims to establish the     feasibility and reporting variables for dynamic MRI enemas in ileal pouches and defaecating     enema pouchography.   "
27551|NCT02925117|"     This is an 88-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled     multicenter study to evaluate the safety and efficacy of ABT-494 (upadacitinib) in adult     subjects with moderate to severe atopic dermatitis. In Period 1, subjects will be randomized     in a 1:1:1:1 ratio to one of four treatment groups.   "
27542|NCT02925234|"     This is a prospective, non-randomized clinical trial that aims to describe the efficacy and     toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of     patients with advanced cancer with a potentially actionable variant as revealed by a genomic     or protein expression test. The study also aims to simplify patient access to approved     targeted therapies that are contributed to the program by collaborating pharmaceutical     companies and to perform next generation sequencing on tumor biopsies for biomarker analyses.     Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin     lymphoma for which standard treatment options are no longer available and acceptable     performance status and organ function. A genomic or protein expression test must have been     performed on the tumor and the results must identify at least one potentially actionable     molecular variant as defined in the protocol. Results from the molecular profiling test will     be used to determine an appropriate drug(s) from among those available in the protocol. The     choice of drug will be supported by a list of potential profiles, a molecular tumor board, a     knowledge library and by study coordinators for review and approval of the match. The     protocol-specified treatment will be administered to the patient once any drug-specific     eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future     genetic studies. All patients who receive treatment with a drug available in the protocol     will be followed for standard efficacy outcomes including tumor response, progression-free     and overall survival as well as duration of treatment. In addition, treatment related     toxicity will be evaluated.   "
27603|NCT02924428|"     The purpose of the study is to evaluate the efficacy of facial acne vulgaris treatment using     the Venus Versa Diamondpolar applicator in combination with the Venus Versa AC dual     applicator using two intense pulsed light wavelength bands.   "
27543|NCT02925221|"     This study is part of the Health Canada approval requirement for tolvaptan and is an     observational, non-interventional study (NIS) describing the impact of tolvaptan on     ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO)     Questionnaires. The study is also describing the time to renal replacement therapy (RRT),     such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal     and hepatic), in ADPKD patients treated with tolvatan (JINARC™)   "
27544|NCT02925208|"     Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant.     Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is     important to safely perform the posterior tympanotomy. Anatomical variation of facial nerve     such as lateral or anterior position of vertical segment of facial nerve, will render this     approach challenging. In this research, investigators proposed a Radiological Classification     system of the position of vertical segment of facial nerve in relation to the lateral     semicircular canal to predict difficult cases with narrow facial recess.   "
27545|NCT02925195|"     The goal of this clinical trial is to determine individual-level genetic and metabolic     characteristics that modify the response to cholecalciferol treatment.      This study is double blind, parallel design, randomized clinical trial that will assess     genetic and metabolic characteristics that modify the response to cholecalciferol treatment.     . Eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000     international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total     duration of 16-weeks. The planned sample size is 1,600. The primary aim of this study is to     identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the     biologic response to vitamin D3 treatment, assessed by changes in serum concentrations of     parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.   "
27546|NCT02925182|"     The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in     reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were     included to the study. For each patient, ulceration were randomly assigned to the test or the     control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact mode. In     the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain was     evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a clinician.   "
27547|NCT02925169|"     Cricoid is considered the narrowest part with the shape of airway defined as elliptical with     the subglottis as the narrowest region.      This study using imaging modality (2D CT images) is done to determine any differences in     airway shape between infants and children, and to evaluate the dimensional transition between     the subglottic area and the cricoid ring.   "
27548|NCT02925156|"     This project examines whether individuals' amount of activity energy expenditure (AEE) is     related to adiposity and adiposity/diabetes-related hormones in a diverse sample of 2500, and     to test the ecological hypothesis that a decline in levels of AEE is an important cause of     the increases in obesity that are currently taking place in many societies.      One goal is to use doubly labeled water and/or accelerometers to objectively measure activity     energy expenditure in community samples from five adult populations across the spectrum of     obesity risk. From each site, (i.e., Ghana, South Africa, Seychelles, Jamaica, and the US),     500 black adults will be recruited. Among all participants, AEE will be measured using     accelerometers and in a subset of 75 per site, AEE will also be measured by doubly labeled     water.      The doubly labeled water sample will be used to confirm site-specific concordance with the     accelerometer measurements and to estimate population mean levels of AEE. Additionally, body     composition, dietary intake, fasting glucose, insulin, adiponectin, leptin and ghrelin will     be measured. The relationships between calories expended in activity and body composition,     dietary intake, glucose, hormones and adipocytokines, both within and between each population     using doubly labeled water and accelerometers will be examined. In this longitudinal study,     weight will be measured at 12 and 24-months, and AEE by accelerometer will be assessed at     enrollment and again at 2-years of follow-up; associations between change in AEE and change     in weight will be estimated.      The central purpose of this project is to test whether AEE or change in AEE can be identified     as a contributory mechanism to population-wide weight gain and, if so, to quantify its     importance. In addition, we seek to understand the interrelationships between the     adipocytokines and the hormones ghrelin and insulin as well as AEE in the regulation of body     weight across the continuum of body mass indices (BMI) represented by these five populations.   "
27549|NCT02925143|"     To assess the impact of an e-learning course in neuromuscular monitoring on the frequency of     application of objective neuromuscular monitoring for assessment of depth of neuromuscular     blockade in general anaesthesia and secondarily on the incidence of residual neuromuscular     blockade after anesthesia.      We will collect data prospectively from 6 Danish anaesthesia departments from the time of     intervention, using data from the Anaesthesia Information Management System (AIMS). Baseline     data is obtained from another study based on the same data extraction procedure     (NCT02914119).   "
27550|NCT02925130|"     Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and     chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise     and muscle performances. The underlying mechanisms are however unclear. Some data suggest     that Salbutamol may have some effects on the central nervous system which may explain the     improved exercise and neuromuscular performances. The present study aims to assess the     effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using     neurostimulation techniques and magnetic resonance imaging.   "
27553|NCT02925091|"     Helicobacter pylori infects ~ 50% of the world's population and a quarter of the European     population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers     and gastritis. Chronic infection with H. pylori is a risk factor for the development of     stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of     success for an antimicrobial eradication therapy is drastically reduced by the significant     increase in antibiotic resistance in Austrian H. pylori isolates. The currently available     data were obtained however from narrowly defined geographical regions and the clinical     routine without information on patient selection. We suspect a considerable geographical     variability of resistance patterns and a clinical bias for a preferential investigation of     patients with unsuccessful, empirical eradication therapy. The objective of the proposed     study is therefore an Austria-wide collection of data on H. pylori resistance in a     prospective clinical study. The data thus collected will enable a significant improvement in     current treatment recommendations.   "
27554|NCT02925078|"     The primary objective of this study is to compare the amount of implant marginal bone loss     radiographically and probing depth in between thin and thick mucosa group that will receive a     machined collar implant.      Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant     with smooth collar.   "
27618|NCT02924233|"     This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of     Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every     second week.   "
27555|NCT02925065|"     This controlled prospective cohort study is designed to assess the feasibility and effect of     bi-weekly non-traditional guitar classes on PD patient's self-reported and measurable     outcomes including upper extremity function, motor findings, quality of life, mood, and     cognitive findings. Prior to conducting a larger study, this study seeks to assess the     possibility that participation in an instrumental performance activity in a group setting may     improve outcomes in PD patients. Twelve patients with PD will be recruited to participate in     the guitar class group (intervention) in addition to usual treatment, while another group of     12 patients with PD will be recruited to the control group to receive only their usual     treatment.   "
27556|NCT02925052|"     A randomized controlled prospective study of orogastric tube placement with the Gastric Tube     Guide vs conventional placement.   "
27557|NCT02925039|"     The sit-to-stand (STS) movement is a key functional movement critical to independent living.     This movement is physically demanding to conduct, especially in older adults, and in the     presence of physical impairments associated with a range of conditions, such as stroke,     osteoarthritis, Parkinson disease and hip arthroplasty. A limited capacity to perform this     movement increases the risk of falls, dependency and increased support for personal care and     rehabilitation. Restoring independence in this movement is, therefore, considered a priority     for physical rehabilitation.      Sit-to-stand capacity can be regained through participating in rehabilitation exercises.     Providing feedback on performance of this movement could enhance the training. Thus, it is an     essential aspect of physical therapy. Healthcare providers are required to meet the needs of     an increasingly frail population as well as meeting national, evidence-based, guidelines for     improving outcomes in conditions such as stroke which includes an increase in the practice     repetition of functional movements. Reliance on rehabilitation staff to provide practice,     however, places a limit on practice volume, potentially restricting outcomes. Using     technology to enhance safe, repetitive practice of this movement with minimal supervision     from skilled professionals would be beneficial to patients and rehabilitation services.      The primary aim of this study is to test the acceptability and feasibility of a STS training     system that enhances movement feedback to patients undergoing rehabilitation. A secondary aim     is to gather data on the effectiveness of the system compared to conventional rehabilitation.     This information will inform a statistically powered phase 2 trial.   "
27558|NCT02925026|"     Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme     supplementation in improving environmental enteric dysfunction in Malawian children   "
27559|NCT02925013|"     This study aims to investigate the omega 3 lipid profile in pregnant women at term and their     fetuses compared to non pregnant women , in normal western diet adding no supplementation   "
27560|NCT02925000|"     This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety,     Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in     Patients with Advanced Malignancy.   "
27561|NCT02924987|"     Multicenter randomized trials have demonstrated the safety and efficacy of intravitreal     anti-vascular endothelial growth factor (anti-VEGF) agents for the treatment of diabetic     macular edema. The results are generally good in the short term, with approximately 75% of     patients maintaining or improving vision after initiation of treatment. Despite this     favorable outcome, the observation of persistent fluid is not infrequent during treatment,     even in patients undergoing monthly treatment sessions. Persistent fluid was observed on     optical coherence tomography (OCT) in 70.9% of patients receiving bevacizumab monthly and in     79% of those receiving bevacizumab as needed at the end of the first year in the Comparison     of diabetic macular edema. Treatment Trials. It is possible that resolution of this fluid,     especially when it is centrally located (i.e., foveal), might result in better visual     outcomes.      A drug with higher VEGF-binding affinity may help patients with persistent fluid despite     treatment with bevacizumab. Aflibercept is a new intravitreal VEGF antagonist approved on 28     November 2014 by the Health Canada for the treatment of diabetic macular edema.      In contrast to the antibody-based VEGF binding strategy used by bevacizumab, aflibercept     incorporates the second binding domain of the VEGFR-1 receptor and the third domain of the     VEGFR-2 receptor. By fusing these extracellular protein sequences to the Fc segment of a     human IgG backbone, developers have created a chimeric protein with a very high VEGF binding     affinity. Aflibercept binds all isomers of the VEGF-A family like bevacizumab, but it also     binds VEGF-B and placental growth factors 1 and 2,1,2 which have been both implicated in the     pathogenesis of diabetic retinopathy and of age-related macular degeneration. In addition,     because of the increased trough binding activity and the stronger binding affinity,     aflibercept should be efficacious in neutralizing VEGF more effectively and for longer     duration.   "
27562|NCT02924974|"     This study will investigate if a single shot of spinal morphine will increase patient     satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy   "
27563|NCT02924961|"     The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and     the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design     on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy     (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric     Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the     MB and FB Triathlon knee.   "
27565|NCT02924935|"     This study evaluates the role of histidine in patients with HARS Syndrome. Children with HARS     Syndrome will receive oral nutritional supplementation with histidine at a dose which will be     increased in the event of acute febrile illness. Vision, hearing and plasma biomarkers will     be monitored throughout the study period.   "
27566|NCT02924922|"     Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality for     small renal masses. In this setting, robot-assisted and conventional laparoscopic approaches     are gaining more consensus every day. However, until now, no superiority of one technique     over the other has yet been demonstrated, especially on postoperative function recovery.      This study compares oncological and functional outcomes after laparoscopic partial     nephrectomy versus robot assisted partial nephrectomy.   "
27567|NCT02924909|"     Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in     a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus     carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive     surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14     days after de first cycle to determine the relation between metabolic response and survival.   "
27640|NCT02923947|"     The purpose of this study is to assess the effect of severe renal impairment on the levels of     AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal     renal function.   "
28229|NCT02916186|"     The goal of the present study is to compare the amount of root coverage resulting from     subepithelial connective tissue graft and acellular dermal matrix associated with tunnel     technique among patients suffering from multiple gingival recession.   "
27568|NCT02924896|"     Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite     regulation      Design: A randomized, single blind, cross over design including 4 single study visits     separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where     different types of fat will be given.      Population: 12 healthy males and females aged between 18 and 60 years with body mass index     (BMI) between 18.5- 29.9kg/m2 and normal fasting plasma glucose and no evidence of insulin     resistance will be recruited. No-pre existing morbidity including cardiac, hepatic or renal     disease, history of diabetes, hypertension or hyperlipidaemia.      Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake like     drink containing fat, protein and carbohydrate. A cannula will be inserted for the duration     of the study day but no blood will be taken. Studies show than during the first visit stress     response can affect the metabolic response to the study drink resulting in inaccurate     results.      Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more study     visits separated by a week to test the metabolic response to the following fats: palm olein,     interesterified palm olein and soybean oil in random order. Participants will be asked to     complete a visual analogue scale questionnaire about their appetite at each time point.     Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will be     measured.   "
27569|NCT02924883|"     This Phase II, double-blind, randomized, placebo-controlled multicenter study will     investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab     or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC     who have received prior trastuzumab and taxane based therapy, either alone or in combination,     and/or who have progressed within 6 months after completing adjuvant therapy.   "
27570|NCT02924870|"     Main objective: To compare the level of physical activity (PAL) at 12 months in patients with     moderate to very severe chronic obstructive pulmonary disease (COPD) between those who     completed a health education program and those who did not.      Study patients. Subjects older than 35 years; diagnosis of moderate to very severe COPD (FEV1     <80% predicted), established at least 3 months; current or former smoker with an accumulated     consumption >10 packs x year; and hospital admission for COPD exacerbation.      Design. Randomized, parallel and open-label clinical trial, controlled with conventional     treatment.      Intervention: During hospitalization, selected patients will receive conventional treatment.     At discharge, they will be randomized (1:1) to control group [treatment and follow-up     according to conventional clinical practice] or intervention group [in addition to     conventional treatment and follow-up, the patients will be referred to a nursing consultation     for perform two health education sessions, at 15 and 30 days after hospital discharge].      Measurements. At 15 days and 12 months after discharge, the following determinations will be     made: anthropometric characteristics; clinical evaluation (smoking history, date of COPD     diagnosis, comorbidities, current medication; health care utilization; moderate or severe     COPD exacerbations); questionnaires (mMRC, Charlson, COPD-specific co-morbidity test (COTE),     COPD Assessment Test (CAT) and LCADL), spirometry and six-minutes walking test; and     evaluation of daily physical activity using an accelerometer.   "
27571|NCT02924857|"     The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study,     designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in     superficial femoral or popliteal arteries with the intention of obtaining regulatory approval     to market this device in the United States   "
27572|NCT02924844|"     The aim of this before-after study was to assess the impact of a clinical pharmacy bundle of     care activities on patient outcomes (length of hospital stay as a primary endpoint) and cost     expenditure in two French ICUs.   "
27573|NCT02924831|"     1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and          its variability (HRV).        2. To compare the curative effects and the HR/HRV indices between applicationa of different          acupoints as well as different treatments (acupuncture and moxibustion).   "
27574|NCT02924818|"     Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease     (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are     characterized by lung inflammation and remodelling. Clinical, functional, microbiological,     biological, pathological and prognosis features are highly variable and heterogeneous. A     precise phenotyping is a key-element to better understanding the pathophysiology of these     chronic inflammatory diseases and to develop innovative treatment strategies.      The objectives of this prospective study is to analyze the clinical, demographic, biological,     morphological, pathological, and microbiological characteristics in a cohort of patients     diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between clinical,     demographic, biological, morphological, pathological, and microbiological features will be     assessed.      The Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the     RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a     monocentric study conducted at the University Hospital of Reims, France. Adult patients (>18     year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD,     bronchiectasis, or CF will be considered for inclusion. Patients will sign an informed     consent for inclusion. Exclusion criteria include subjects protected by the law as required     by the French authorities. Control patients with no respiratory diseases after clinical and     pulmonary function tests assessment will be also included. The expected number of patients     included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25; controls, n=50).     Inclusion will be conducted for 36 months from September 2016 (9/30/2016) to September 2019     (9/30/2019).      For all COPD, ILD, bronchiectasis, and CF patients included, data will be registered at     inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care     with no specific therapeutic intervention. For control patients, data will be registered at     inclusion with no follow-up.      Data will be registered in a centralized anonymized database. The characteristics of the     patients will be described as mean and standard deviation for quantitative data and as number     and percentages for qualitative data. Comparisons and associations between groups and     variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as     applicable. A p<0.05 will be considered as significant.      This study should help to better characterize clinical, demographic, biological,     morphological, pathological, and microbiological characteristics and phenotypes in chronic     inflammatory respiratory diseases.   "
27575|NCT02924805|"     Comparison of telemedical prehospital emergency care and conventional on-scene physician     based care of hypertensive emergencies and urgencies. The adherence to current Guidelines     should be researched.   "
27576|NCT02924792|"     In this study we investigate the impact of two CE marked and FDA approved sternal needles in     comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and     the possible hemolysis of red cells post-transfusion in a population of healthy military     officers.   "
27577|NCT02924779|"     This is a small observational study investigating the physical changes that occur to epidural     catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a     correlate for the position of the catheter in the patient we will investigate a connection     between the position and e function during labour. This information may be useful in guiding     the physicians responses to epidurals that do not provide adequate analgesia to aid in     deciding on the most appropriate action   "
32937|NCT02854631|"     The primary objective of this study is to evaluate the safety and tolerability of selonsertib     (GS-4997) in combination with prednisolone versus prednisolone alone in participants with     severe alcoholic hepatitis (AH).   "
27580|NCT02924740|"     Pelvic Floor Muscle Training (PFMT) is the basis of conservative treatment in women with SUI.     In systematic reviews, PFMT was recommended as a first option for treatment of SUI. The aim     of PFMT is to improve sphincter activity and increase the support of bladder and urethra.     Recommendations regarding the prevention and treatment of SUI with PFMT include Knack     maneuver (the conscious contraction of the pelvic floor before and during the abdominal     pressure increases); pelvic floor exercises to enhance the structural support and endurance     of pelvic floor muscles; adding transversus abdominis contraction; and functional     rehabilitation.It was reported that the progressive overload principle should be considered     to improve the muscle strength and endurance. According to this principal, resistance against     to movement, duration and/or frequency should be increased to obtain the optimal response.     There are a lot of methods to run a muscle or muscle group based on the progressive overload     principal. These are adding resistance or weight, increasing the duration and number of     contraction, changing the type of exercise and the range of movement. In the literature, it     was reported that special vaginal or rectal tools, vaginal cones or tampons might be used to     establish resistance during the pelvic floor muscle exercises.the use of cones in a different     way may provide extra benefit for patients: patients can be instructed to perform pelvic     floor muscle contraction and try to pull the cone or the other tools out of the vagina. In     this study, investigators preferred to use vaginal tampons since pulling the cone out of the     vagina cause the elimination of the weight of the cone. Vaginal tampons are also sterile,     hygienic, and single use. There is no study investigates the effects of vaginal tampon     exercises in the literature. Therefore, the aim of this study is to investigate the effect of     the vaginal tampon training adding to PFMT on symptoms of the urinary incontinence, the     strength and the endurance of pelvic floor muscles and the quality of life.   "
27581|NCT02924727|"     The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a     target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg     twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of     composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event     analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary     congestion, with no known prior history of chronic HF..   "
27582|NCT02924714|"     The trial The stop-GIST trial is an Oslo University Hospital sponsored, prospective,     open-label, 1-group, multicenter phase II trial evaluating discontinuation of imatinib in     highly selected patients treated with imatinib longer than 5 years for oligo-metastatic GIST     (≤ 3 metastases) and who have no detectable overt GIST lesions on CT/MRI imaging following     complete surgical resection (R0/R1-resection) or radiofrequency ablation (RFA) of the     metastases.   "
27583|NCT02924701|"     Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by     destruction of the small intrahepatic bile ducts. sCD163 is a macrophage activation marker     shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The     investigators want to investigate whether sCD163 and sMR correlate with disease severity in     patients with PBC, and whether sCD163 and sMR can predict short term disease progression,     changes in quality of life and death in these patients.   "
27585|NCT02924675|"     Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be     primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of     referred otalgia involves several non adjacent nerve territories as those of head, neck or     ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized     far from the ear but sharing the same innervation. In this contest, the otoscopy is normal.      Four cranial nerves participate in the sensory innervation of the external ear: the     trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the     Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the     external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the     Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However, there     are important interindividual anatomical variations.      The relationship between referred otalgia and probable nerve damage has been described. In he     oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then     explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic     component.      In the literature, the curative treatment of referred otalgia is the cancer treatment.     However, the high intensity of referred otalgia leads the patients to a large consumption of     analgesics in particular of opioids. These latter are particularly adapted for pain resulting     from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of gamma     aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent voltage     channels in the central nervous system. its effectiveness has been demonstrated for the     treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions in the     bone marrow but also the postoperative pain when the molecule is administered after the     surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two or     three daily doses.      The purpose of this study was to evaluate the activity of pregabalin administered orally for     three weeks after the anesthesia consultation on the intensity of the pain of referred     otalgia and on its neuropathic component.   "
27586|NCT02924662|"     Studies have reported that the patient's psychological state such as anxiety, depression and     other emotion affect the therapeutic effect of osteoarthritis, also may be the important     reason for the poor knee joint osteoarthritis efficacy.      The aim of this study are firstly to investigate the depression status of patients with     osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression     will affect depression status, ultimately, provide reference for clinical.   "
27587|NCT02924649|"     Increasing focus on the negative effects of bed rest have become more apparent in the     intensive care unit within the last decade. A few studies have found an association between     early rehabilitation starting at the intensive care unit and outcome after discharge from     rehabilitation. The early mobilization presents with challenges regarding haemodynamic     stability. The purpose of this randomized controlled trial is to investigate the effect of     early and intensive mobilization on functional parameters as well as haemodynamic stability.   "
27588|NCT02924636|"     The purpose of this study is to assess the efficacy of an electronic-based intervention to     help pregnant overweight and obese women gain an appropriate amount of weight and improve     their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a     composite outcome including instrumental delivery and Caesarean section, as clinically     relevant outcomes because the mode of delivery is one of the major goals of the obstetrical     management and is is strongly associated with body mass index and gestational weight gain.   "
27589|NCT02924623|"     Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA)     disease activity, as quantified by the patient's global assessment (PGA) and by the     evaluator's global assessment (EGA).      The objectives of this study were:        1. to explore the extent and reasons for the discordance between patients and physicians in          their perception of RA disease activity        2. to determine if this discordance at baseline is associated with RA outcomes at 1 year          (remission, function and structure) in early arthritis (EA) in daily clinical practice.             -  Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2               swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR               criteria for RA at baseline      Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed.     Multivariate linear regression was used to determine the patient and EA features     independently associated with discordance (calculated as PGA - EGA). Logistic regression was     used to analyze discordance as│PGA - EGA│≥20.      Multivariate logistic models were used to determine if discordance at baseline is associated     with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25)     and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.   "
27591|NCT02924584|"     Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in     relatively early stages. Only 700 metastatic breast cancer were registered in Official Cancer     Registration 2012, while more than11,305 were registered as early breast cancer. With broadly     application of aromatase inhibitors, hormonal-receptor-positive breast cancer patients can     survive longer and longer. However, there is no prevalence of metastatic breast cancer can be     available yet. NHIA database coverage is more than 90% population in Taiwan, thus it can be     an appropriate surrogate of prevalence. In this retrospective database analysis, we will     explore the real world experience on aromatase inhibitor use for breast cancer in Taiwan.   "
27592|NCT02924571|"     The aim of this investigation is to compare the use of bone marrow aspirate concentrate     (BMAC) and allograft versus to recombinant human bone morphogenetic protein-2 (BMP) in     subjects undergoing elective thoracolumbar spinal fusion with interbody support. The     investigators will look at the safety and efficacy of these two different surgical methods by     assessing surgery outcomes and participants' quality of life.   "
27593|NCT02924558|"     The goal of this study is to evaluate the effects of replacing some refined starches and     added sugars with a combination of egg protein and unsaturated fatty acids on markers of     cardiometabolic health in men and women with hypertriglyceridemia.   "
27594|NCT02924545|"     Evaluate the support of osteoporosis in women over 50 years with severe osteoporotic     fractures (hip, vertebral, rib, Humeral, pelvic fractures) in the Nîmes University Hospital     taking prediction of treatment of osteoporosis as criterion.   "
27595|NCT02924532|"     The main objective of this study is to establish an optimal threshold Early parathormon (PTH)     assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive     value of hypoparathyroidism highest possible.   "
27596|NCT02924519|"     Shoulder disorders are frequent, often associated with pain and occur in 7-34% of the general     population and in 21% of the elderly population.      Of particular interest is prediction of postoperative pain after outpatient arthroscopic     shoulder surgery since the clinical experience is that surgery does not always provides pain     relief and the interindividual variation in acute postoperative pain intensity is     significant. In addition, a Swedish study has shown that shoulder operations are associated     with longer convalescence than other orthopaedic outpatient surgeries.   "
27597|NCT02924506|"     Nowadays, there is no clinical and radiological study comparing two different types of mobile     implants in patients requiring surgical treatment for symptomatic cervical disc disease.     Thus, the choice of the ideal implant remains uncertain.      The goal of this work is to compare the impact of two types of mobile implants in height     drives, solicitation facets, positioning and collection of prostheses within the     intervertebral spaces.   "
27611|NCT02924324|"     The purpose of this study is to identify whether or not the addition of a numbing medicine     that is injected directly into the site of the bone marrow procedure can reduce pain and the     use of opioid pain medication after bone marrow procedures. The addition of this medicine,     called ropivacaine, is the experimental part of this study. This is the first time     ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.   "
27861|NCT02921048|"     This observational study recruits healthy individuals who have been routinely taking high     amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid     (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating     the cardiopulmonary effects of exposure to ambient air pollution.   "
27598|NCT02924493|"     Many patients with endometriosis experience extra genital and abdominal symptoms as a major     part of their problem. This includes gastrointestinal dysfunction with pain, urinary symptoms     compatible with interstitial cystitis and gastrointestinal symptoms resembling the irritable     bowel syndrome (IBS). Such problems may be secondary to changes in autonomous neuronal     structure and function elicited by the endometriotic elements, which may cause a visceral     syndrome with the above mentioned symptoms.      The investigators hypothesize that dietary treatment will improve the experience of     gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related     irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study     investigating patients with both endometriosis and IBS, is to test the application of a low     FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to     stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot     study is to investigate the applicability of a placebo diet in patients with endometriosis     and to investigate the compliance in both intervention group and control group. In addition,     the aim is to investigate whether the participants find the diet manageable and whether they     are able to identify the placebo diet.   "
27599|NCT02924480|"     Patients scheduled for a cystectomy at Charleston Area Medical Center (CAMC) will be enrolled     into a randomized, double blinded clinical trial to assess if postoperative pain and ileus     are reduced by perioperative intravenous lidocaine infusion versus placebo. The hypothesis is     that patients receiving the lidocaine infusion will experience better pain control and ileus     resolution. It is believed that lidocaine patients will also have less opioid requirement,     less mortality, a shorter length of stay, less nausea /vomiting, and fewer adverse events.   "
27600|NCT02924467|"     Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,     only about half of children are vaccinated annually, leading to substantial influenza disease     in children and spread of disease to adults. A major barrier is that families are not     reminded about the need for their children to receive influenza vaccination. The     investigators will evaluate the impact of patient reminder/recall performed by state     immunization information systems to improve influenza vaccination rates by using three     clinical trials in two states. The investigators will assess effectiveness and     cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The     investigators will disseminate the state immunization information system-based     reminder/recall system to all states for use for seasonal and pandemic influenza vaccinations     with the goal of lowering influenza morbidity.   "
27601|NCT02924454|"     The aim of this study is to investigate whether intravenous lipid emulsion is effective in     attenuating the clinical effects of a cardioactive drug, exemplified by the beta-blocking     agent metoprolol. In addition, the investigators will clarify how intravenous lipid emulsion     affects the pharmacokinetic parameters of metoprolol.   "
27604|NCT02924415|"     Bipolar disorder patients frequently presents recurring episodes and often experience     subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low     quality of life, relapses of disease and recurring hospitalization. Early diagnosis and     appropriate intervention may play a role in preventing the neuroprogressive course of bipolar     illness. The new technologies represent an opportunity to develop psychological standardized     treatments using internet devices that minimizing the limitations of face to face treatments     because of its accessibility that allow adjusting to the availability of each user. However,     although exist many online psychological programs through web and mobile devices for bipolar     disorder, there is not evidence about their efficacy and effectiveness due to the variability     in measures and methodology used.   "
27605|NCT02924402|"     The purpose of this study is to determine the safety and tolerability of weekly intravenous     (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after     the first dose, and then to determine the MTD after second and subsequent infusions.   "
27606|NCT02924389|"     The purpose of this study is to find out how well the HIV medication dolutegravir gets into     different parts of the body: including blood plasma, special blood cells, and rectal tissue.     Specifically, investigators want to compare how fast dolutegravir lowers the HIV viral load     in these three different sites. In addition, investigators seek to learn if there are any     differences in how dolutegravir acts in males and females. Results of this study will provide     more information about HIV medications and their limitations. In the future, this could help     create better HIV medications that can get into these hard-to-reach places and eventually     cure HIV infection.   "
27607|NCT02924376|"     The purpose of this study is evaluate the efficacy of INCB054828 in subjects with     advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation     who have failed at least 1 previous treatment.   "
27608|NCT02924363|"     The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to     define the anatomic and functional remodeling that results from MitraClip implantation. A     total of sixty (60) patients undergoing MitraClip implantation will be enrolled across     multiple sites. The severity of mitral regurgitation, cardiac morphology and function will be     assessed in these patients at BASELINE (within 30 days prior to MitraClip implantation),     during the ACUTE REMODELING PHASE (pre-discharge following implantation), and during the     CHRONIC REMODELING PHASE (6 months post-implantation).   "
27609|NCT02924350|"     This single center study will investigate the efficacy of an experimental stannous fluoride     containing dentifrice in relieving DH compared with a standard fluoride dentifrice after     short term use.   "
27610|NCT02924337|"     The purpose of this study is to assess the effect of a single therapeutic dose and a single     supra-therapeutic dose of imeglimin on the QT/QTc interval   "
27862|NCT02921035|"     This is an open label, non randomized, uncontrolled, multicenter, single arm observational     study. In this study, the enrolled subjects will be treated with Rebif human serum albumin     (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc),     thrice in a week (tiw) for 24 months.   "
27612|NCT02924311|"     The main objectives of this observational study are to describe outcomes, monitoring and     treatment patterns of patients with diabetic macular edema in routine clinical practice who     are either treatment naïve patients or previously treated patients. The total study     population will be evaluated as well as the two subgroups (previously treated patients and     treatment naïve patients).      This study is designated to answer French Health Authority (HAS Haute Autorité de Santé)     requirements.   "
27613|NCT02924298|"     In the past two decades, the prevalence of obesity in the US has increased from 23.2% to     32.9%. This epidemic is fueling the Chronic Kidney Disease (CKD) epidemic. This likely is the     major challenge facing the nephrology community in the next decade and beyond. This pilot     study is designed to test the feasibility of the Sit Less, Interact, Move More (SLIMM)     intervention and to determine its preliminary impact on light physical activity (PA) levels.     Increasing light PA may have significant impact on both obesity and slowing the progression     of CDK.   "
27614|NCT02924285|"     For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural     heart disease the current European Guidelines for the management of patients with ventricular     arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as     amiodarone with a class IIa indication. Due to the lack of randomized data this study     investigates the comparison of catheter ablation and antiarrhythmic drug therapy for PVC     treatment in patients with structural heart disease. Therefore, patients will be randomized     to one of two treatment strategies: 1) catheter ablation, or 2) antiarrhythmic drug therapy     (amiodarone, flecainide/propafenone if compatible with underlying heart disease).   "
27615|NCT02924272|"     The purpose of this study is to provide continued access to ixazomib and evaluation of the     long-term safety profile of ixazomib.   "
27616|NCT02924259|"     The purpose of this study was to examine the effects of a foam rolling intervention on     pressure pain thresholds (PPT) of the ipsilateral antagonist and contralateral muscle groups.     Through this research we sought to gather data to further develop the methodology for future     studies of this intervention.   "
27617|NCT02924246|"     Rationale: Oral vaccination is known to induce a systemic immune response as well as an     immune response in mucosal tissues, and can therefore serve as a model to study systemic and     mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model     vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have     been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this     pilot, in this study oral cholera vaccination will be applied to study the support of     immunity by raw milk, compared to heat-treated milk. The study design has been optimised     based on previous results: study duration is extended and sample size is based on relevant     change and known variation in the primary outcome parameters.      Infections are an important worldwide cause of death, both in elderly and young children.     Therefore, support of immunity could help to reduce the incidence of infections. To screen     the potential of specific foods or food ingredients to support immunity, oral vaccination can     serve as a model. In a previous study, this model was developed using oral cholera     vaccination in human adult volunteers. In that study, raw milk was shown to support the     immune response to vaccination. In this follow-up study, the effect of raw milk will be     compared with pasteurized and ultra-heat treated (UHT) milk.      Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the     immune response as induced by oral cholera vaccination, in comparison to raw milk and to     regular vaccination.      Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.      Study population: Healthy subjects of 18-50 years of age.      Interventions: 1) Raw milk, obtained from farms that comply to the high quality requirements     for production of raw milk, and that has been screened according to the safety criteria for     raw milk; 2) commercially available full-fat UHT milk; 3) commercially available full-fat     pasteurized milk.   "
27619|NCT02924220|"     Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria     monocytogenes (Lm). It manifests as septicemia, central nervous system (CNS) infection and     maternal-fetal (MF) infection. Its associated overall mortality is very high, above of 30%. A     better knowledge on the factors involved in its occurrence and in clinical manifestations is     therefore needed to improve outcome.      A number of frequent acquired risk factors for listeriosis have been identified, such as     pregnancy, diabetes, cancer, HIV infection, and immunosuppressive therapies. However, no     genetic study on host susceptibility to listeriosis in humans has been performed so far, in     the absence of prospective collection of patients' samples. Also, listeriosis diagnosis is     based on Lm culture from clinical samples. This method lacks sensitivity, and the     contribution of biomarkers to listeriosis diagnosis and prognosis has not been evaluated.      The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA), is     the first national case-control prospective study on listeriosis. It is implemented since     2009 and enrolls all culture-proven cases declared to the NRCL: and collects for each patient     clinical and biological data and biological samples. Controls with comparable background and     presentation are also included. 818 cases have been included (427 S, 252 CNS and 107 MN) over     3.5 years, along with 456 controls.      The aim of the study is to identify human genetic susceptibility factors to listeriosis,     biomarkers to improve its diagnosis and prognosis (survival or death), and thereby help     improve management of patients with listeriosis.      Samples from the completed cohort will be analyzed : SNPs genotyping and exam sequencing;     biomarkers a identification in serum and plasma of patients and controls by simultaneous     multi-analyte and metabolomic profiling.   "
27620|NCT02924207|"     To determine the impact of an electronic decision support tool on physician decision making     and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary     endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of     therapy and patient satisfaction with therapy. Study hypothesis is that use of the PATH     decision tool will produce greater reduction overall in measurements of hemoglobin A1c in     patients who participate and follow the PATH decision tool than patients who elect not to     follow the PATH decision tool. PATH decision tool will provide more cost effective solutions     for management of diabetic medication than current methods.   "
27621|NCT02924194|"     The purpose of this study is to evaluate the safety and effectiveness of deep brain     stimulation of the nucleus basalis of Meynert (also called the nbM) at improving memory in     Parkinson's disease patients with mild cognitive impairments and memory difficulties.     Patients with Parkinson's disease (PD) that are eligible for Deep Brain Stimulation (DBS)     therapy for improvement of their motor symptoms and with evidence of mild cognitive     impairments and memory difficulties will be enrolled.   "
27653|NCT02923778|"     This phase II trial studies the side effects of talimogene laherparepvec and radiation     therapy and to see how well they work in treating patients with newly diagnosed soft tissue     sarcoma that can be removed by surgery. Biological therapies, such as talimogene     laherparepvec, use substances made from living organisms that may stimulate or suppress the     immune system in different ways and stop cancer cells from growing. Radiation therapy uses     high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors.     Giving talimogene laherparepvec and radiation therapy may work better in treating patients     with soft tissue sarcoma.   "
27622|NCT02924181|"     Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter     ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing     catheter is a new catheter which has valuable tools to monitor and increase the efficacy of     PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on     immediate PV isolation and outcome. However, there might be confounding factor as     inter-individual variation. Therefore, we would like to compare the efficacy of contact     force-sensing catheter within same patient but different veins.      In this study, we would like to confirm the efficacy of contact force-sensing catheter on     immediate PV isolation outcome within same patient. This study randomized the right or left     PVs whether to use the contact force-sensing function or not. The study design will minimize     the inter-individual variation on evaluating the efficacy of contact force-sensing catheter     on immediate PV isolation.      Also, in patients who had recurred AF or AT, we would like to evaluate the long-term efficacy     of contact force-sensing catheter on PV isolation.   "
27623|NCT02924168|"     This is a double blind randomized clinical trial to evaluate the effect of radial shock waves     on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the     territory of the middle cerebral artery. A total of 20 patients will be enrolled and will     undergo motor, functional and cortical excitability evaluations before and after four weekly     sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air     pressure will be applied to the active group, resulting in an energy flux density (EFD) of     approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the     fact that no energy flux will be applied.   "
27624|NCT02924155|"     This study is a randomized, double-blind, placebo-controlled, single day/multiple day dosing,     Phase I clinical trial to investigate the systemic exposure, safety and local tolerability of     SJP002 ophthalmic solution in healthy Korean male volunteers.   "
27625|NCT02924142|"     PICOTS:      P: Kennedy class І patients      I : Mandibular removable partial denture with OT Cap attachment      C: Mandibular removable partial denture with gingival approaching clasp assembly      O: 1ry outcome: Oral Health Related Quality of Life      2ry outcome: Biting force      T: 1 Year      S : Randomized control trial      Research question:      In Kennedy class І patients will the removable partial denture with OT Cap attachment     compared to conventional removable partial denture with clasp assembly results in difference     in Oral Health Related Quality of Life of Patients?   "
27626|NCT02924129|"     The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke     SCS System with feedback control to treat chronic pain of the trunk and/or limbs.   "
27627|NCT02924116|"     The purpose of this study is to determine the effects of the Bioboosti device on sleep for     patients who have been diagnosed with insomnia.   "
27628|NCT02924103|"     A test of a newly designed device (Contamination free bacterial swab). This device can be     used to introduce a standard bacterial swab into the nose without direct or indirect contact     with the nasal vestibule.   "
27629|NCT02924090|"     This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on     ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients     with Major Depressive Disorder. Comparison of etomidate and ketamine on remission of     depressive symptoms with and without pre-emptive hyperventilation will also be studied.   "
28328|NCT02914899|"     The purpose of this study is to improve the efforts of Community health workers (CHWs) by     developing materials to help increase lung cancer screening in NYC Chinese taxi drivers who     smoke or who have quit smoking within the past 15 years.   "
27630|NCT02924077|"     Study was a non-interventional, prospective study of pregnant women who agreed to provide     information about their medication use and certain lifestyle factors on a periodic basis     throughout their pregnancy. Volunteers were recruited by measures such as placement of     pamphlets near pregnancy test kits in pharmacies and by links from carefully selected     websites and social networking sites. Subjects were invited to learn about the study either     through visiting the study web site or phoning a telephone number where a recorded message     described the study and invite eligible women to register for participation.      Participants were asked whether they prefer to provide data via the internet or by     interactive voice response system (IVRS).      Data were collected in the predominant natural languages of the four study countries:     Denmark, the Netherlands, Poland, and the United Kingdom (UK).      Data were collected on use of prescription and non-prescription medication, as well as on use     of herbals and homeopathic medications. More information was be collected from women who     provided their response over the internet than by phone, in order to best utilize the full     capacity of internet- based data collection.   "
27631|NCT02924064|"     This study is designed as a prospective, multi-centre, parallel group, double-blind     randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of     MP-513 (Teneligliptin) in combination with metformin.   "
27632|NCT02924051|"     Healthy eating can be difficult for people who live in poor, geographically isolated regions     of the United States. In particular, people who live in Appalachia often experience food     insecurity (i.e., their access to adequate food is limited by a lack of money and other     resources at times during the year) and lack of access to healthy foods. This pilot study     evaluates the effectiveness of motivational interviewing in helping individuals who live in     these austere regions improve their diets in the context of limited resources and healthy     food availability   "
27633|NCT02924038|"     This is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2     positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which     surgical resection of the tumor is clinically indicated. Co-primary objectives are to     determine: 1) the safety of the novel combination of subcutaneously administered IMA950     peptides and poly-ICLC (Hiltonol) and i.v. administered CDX-1127 (Varlilumab) in the     neoadjuvant approach; and 2) whether addition of i.v. CDX-1127 (Varlilumab) increases the     response rate and magnitude of CD4+ and CD8+ T-cell responses against the IMA950 peptides in     post-vaccine peripheral blood mononuclear cell (PBMC) samples obtained from participating     patients.   "
27665|NCT02923609|"     The primary objective of the study is to investigate safety and efficacy of transendocardial     CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and     function, myocardial perfusion and electrical activity, biomarkers of neurohormonal     activation, patient exercise capacity and clinical outcome.      The secondary objective of the study is to better define the patophysiological background of     HFpEF by the use of multimodality imaging platform, which will include data from     electro-anatomical mapping, cardiac MRI, 2D and 3D echocardiography, high resolution     electrocardiography, and cardiac catheterization   "
27634|NCT02924025|"     The aim of the study is to examine if motivational interviewing can have a positive effect on     weight loss over a 6 month period. By losing weight, the investigators assume the patients     will have a positive effect on quality of life, and also that weight loss will help to     regulate the factors that are present with polycystic ovary syndrom (PCOS); such as menstrual     disorders and infertility.      Participants will be randomly assigned to a treatment group and a control group.      Both groups will be followed as normal with blood samples and other tests such as scans of     the ovaries and measurement of height and weight at the beginning of the study and after six     months.      In addition, there will be a small hair sample taken from the neck at the first consultation     and after 6 months. This is done to measure the stress hormone cortisol in the body over the     duration of the experiment.      The treatment group receive individual motivational interviews by a nurse every 14 days for a     period of six months. After half a year, tests are repeated to see if there are significant     differences between the groups.   "
27635|NCT02924012|"     The aim of this study was to determine the energy demand and the potential to promote reduce     blood pressure of an active video game (AVG). Fourteen hypertensive (56.4 ± 7.5 years) held a     session AVG and traditional sedentary video game sessions (SVG) and walk (WAL), as negative     and positive controls, in order determined randomly. During the sessions, they were observed     oxygen consumption and energy expenditure (EE). Blood pressure (BP) and cardiac autonomic     modulation (CAM) were measured at rest and every 15 minutes of a 60 minute period of recovery     activities. It was also applied a rating scale of pleasure (enjoyment scale).   "
27636|NCT02923999|"     A randomised placebo controlled phase I trial of a monoclonal antibody which neutralises     HIV-1 (P2G12) to be given as a single intravenous infusion to healthy human volunteers to     assess the safety and reactogenicity   "
27637|NCT02923986|"     The primary objective of the Phase 1b study is to determine the dose-limiting toxicity (DLT)     and maximal tolerated dose (MTD) of BP1001 and Dasatinib (Das) in patients with Philadelphia     chromosome positive (Ph+) Chronic Myelogenous Leukemia (CML) in accelerated or blast phase.     The primary objective of the Phase IIa study is to assess the efficacy of the combination of     BP1001 and Das in patients with Ph+ CML.   "
27638|NCT02923973|"     Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about     15 million babies are born too soon every year, causing 1.1 million deaths, as well as short-     and long-term disability in countless survivors. Few prognostic tests are available to     predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a     good predictor of PTB.Different strategies have been adopted for prevention of PTB. The     evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix,     while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations     with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB,     nor in multiple gestations.      However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low     risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a     policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB   "
27639|NCT02923960|"     This is a randomized, double blinded, multi treatment, crossover study intended to compare     the glycemic and insulinemic response after consuming liquid nutritional products in people     with type 2 diabetes.   "
27641|NCT02923934|"     The three tumour streams that will be studied in this protocol are: (i) upper GI malignancies     (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal     cancers).); (ii) neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid     tumours) and (iii) rare gynaecological tumours (including but will not be limited to: vaginal     or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer,     mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa     cell tumours).      The role of immunotherapy is being defined in more common cancer types, however because of     their rarity, the efficacy of immunotherapy for these cancers is poorly defined.      This protocol provides an important opportunity to establish whether the combination of     nivolumab & ipilimumab has efficacy in these cancers.   "
27643|NCT02923908|"     The study is designed to see if, after tasting specific things, whether a child's facial     pattern and voice pattern can determine the difference in something that has a sweet taste,     no taste, and a bitter taste. The investigators will do this by comparing video recordings of     a child's facial expression and voice to the child's response to follow-up questions after     tasting three (3) different substances.   "
27644|NCT02923895|"     This single centre study will be used to investigate the efficacy of an experimental stannous     fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term     use compared with a standard fluoride dentifrice.   "
27666|NCT02923596|"     Purpose of this retrospective study is to review and analyze the information and data that     has been already been generated during the course of routine practice of medicine by the     investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical     care or medical advice for their keloid disorder.   "
27667|NCT02923583|"     The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ®     following administration of a single-dose in healthy volunteers.   "
27669|NCT02923557|"     This clinical trial is designed to evaluate the efficacy of single immediate intravesical     chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy     for primary upper tract urothelial carcinoma (UTUC) patients.   "
27645|NCT02923882|"     Low-birth-weight (LBW) is a major adverse pregnancy outcome in resource-poor countries. About     28% of all neonatal deaths worldwide are directly attributed to LBW. Exposure to biomass fuel     during cooking is associated with LBW. There is unlikely to be any significant change in the     use of biomass fuels in the near future, therefore, interventions targeted to reduce the     harmful effects on poor pregnancy outcomes is warranted. To address this need, the     investigators proposed a locally-made inexpensive prefabricated model of the     100-dollar-kitchen($100Kitchen) with an improved cookstove for resource-poor settings. The     improved cookstove of the $100Kitchen ensure complete incineration of the biomass fuels and     thus, provided safeguard to the pregnant women using these fuels. This study has been     measured the impact of our '$100Kitchen and improved cookstove' intervention as to whether a     pregnant woman residing in a household with a '$100Kitchen and improved cookstove' is less     likely to give birth to a LBW newborn. A cluster-randomized controlled trial has been adopted     in Shahjadpur sub-district in Bangladesh and 628 and 639 pregnant women at 8-12 weeks     gestational age enrolled for each intervention and control area respectively and followed-up     through 42-days post-delivery. Birth outcomes have been noted and the newborns have been     weighted within 72-hrs of the delivery. Non-invasive maternal blood Carbon Monoxide     Hemoglobin saturation (SpCO) level between the intervention and control groups have also been     measured.   "
27646|NCT02923869|"     A cleft deformity of the lip and/or palate is one of the commonest major birth defects.      Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its     peculiarity lies in the numerous care management protocols proposed according to the surgical     techniques used, operating time (between M3 and M18 of life), anesthetic technique and     postoperative management.      This surgery must be associated to a specific care management because of potential associated     complications, especially the risk of obstruction of the upper respiratory tract and     respiratory distress majored by the use of morphine anesthetics during and after surgery.      Adequate postoperative analgesia in children is a vital part of perioperative care. Regional     block given preoperatively in combination with general anesthesia (GA) provides good     preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and     complete recovery and reduced analgesic requirement in the postoperative period.      CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the     risk of postoperative respiratory depression and airway obstruction is important, and     continuous monitoring is required during the initial 24-h postoperative period. Cleft palate     surgery is not only painful, but may also compromise the airway, particularly in children     with craniofacial syndromes. Opiate analgesia has the potential to further compromise the     airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of     respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is     performed using a suprazygomatic approach and is based on a computer tomography study.      The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves     passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory     innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus,     and the posterior nasal cavity. Maxillary nerve block (MNB) through the infrazygomatic route,     used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire     palatine territory. However, this nerve block has led to complications such as orbital     puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall     injury.   "
27647|NCT02923856|"     As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the     eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed     70% in China，and had to drop out of the first-line treatment recommendations. However, with     the increase of treatment time, patients burden, adverse reactions of antibiotics or proton     pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of     the failure to eradicate Helicobacter pylori. But, in terms of population, there are still     more than 70% of the patients with clarithromycin sensitive. Under the guidance with     susceptibility test，7-day standard triple therapy could be used. In this study, investigators     will select the patients with infection of H. pylori and with clarithromycin sensitive.     Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility     testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10     days and 14 days groups. Then, investigators will perform a sequencing for failed treatment     patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally,     investigators will compare the differences between the patients with triple therapy and     traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment     will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per     person.   "
27679|NCT02923427|"     To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on     ventilation parameters and surgical view during Trendelemburg Position laparoscopic     gynecological surgery in cases administered positive pressure ventilation without the use of     neuromuscular agents.   "
27648|NCT02923843|"     Frailty and multimorbidity is one of the biggest challenges of todays health care due to the     demographic development with more and more elderly surviving many diseases that was mortal     just a few decades ago. Health care in Sweden is one of the best in the world, yet many frail     older people do not receive appropriate health care. Several reports have described a     fragmented care with lack of good quality due to lack of a holistic view on the patient and     her situation. At the same time the care given is costly and ineffective with a lack of     continuity. Additionally, there are a lack of hospital beds in Sweden due to the ageing     population and a cut down of beds in the last decades.      There is though a method, Comprehensive Geriatric Assessment (CGA), where studies have shown     many benefits for older patients including less need of hospital beds, better functional     outcomes and a better chance of living at home after an Acute Hospital Discharge, but this     method is not much used in Sweden.      The aim of this study is to show that CGA in an Out-patient Care Setting save hospital beds     without decreasing the quality of care measured by sustained functional capacity. Other     parameters to be evaluated are mortality, degree of frailty, health economy, quality of life,     and cognition.   "
27649|NCT02923830|"     The purpose of this study is to determine the safest and most effective flushing solution for     maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication     rate in patients whose ports are flushed with saline only will be compared to the     complication rate in patients whose ports are flushed with a combination of saline and     heparinized saline.   "
27650|NCT02923817|"     The purpose of study is to determine whether autologous mononuclear cells deriving from the     bone marrow are effective in the treatment of spinal cord injury.   "
27651|NCT02923804|"     This study is a prospective, randomized, placebo-controlled, double-blind trial to determine     the effect of high concentrate omega-3 capsules on the omega-3 status of patients with     non-alcoholic fatty liver.   "
27652|NCT02923791|"     This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar     Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive     doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects     will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of     Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each     of the two study periods. In addition, safety assessments will be conducted throughout the     study.   "
27654|NCT02923765|"     Stroke rehabilitation of hemiplegics primarily lies in motor control and training of     activities of daily life. Whole body aerobics is much less emphasized. Nonetheless,     cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy     people, which is prone to deconditioning. The present study aims to understand the efficacy     of aerobic training in addition to the usual neuro-rehabilitation, including aerobic fitness,     daily activities dependency, anti-inflammation and anti-thrombosis. This is a prospective and     randomized design. The subjects will be recruited from the hospitalized patients in the     rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120 hemiplegic patients due to     stroke will be enrolled and randomized into two groups: combined training (CT) and usual     rehabilitation. Participants in CT will receive aerobics at moderate intensity in addition to     the usual rehabilitation. The program has 35 minutes/session, 5 sessions/week and 4-5 weeks     in total. A constant-power semi-recumbent stepper will be employed as the training modality.     It uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows     for a push and pull motion. Additional 20 healthy participants will also be recruited as the     healthy control. Assessment before and after training includes: (I) graded cardiopulmonary     exercise test using constant-load stepper. (II) Functional Independence Measure. (III)     coagulation system assessment, using Thrombin generation assay and Ceveron alpha (Technoclone     GmbH, Vienna, Austria) : Von Willebrand factor, tissue plasminogen activator, plasminogen     activator inhibitor-1, D-dimer, factor VIII, etc. [the 1st year]; (IV) monocyte-platelet     aggregation and its subtypes, using flow cytometry [the 2nd year]. ( V) systemic     inflammation, platelet activation and prognostic biomarker：C-reactive protein, soluble     P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc [the     3rd year]. Statistical analysis will use ANOVA with post-hoc, two-way repeated measure ANOVA,     etc. The investigation will start after approval and end in 2019, July. We hope this     investigation will establish a more comprehensive rehabilitation program for clinical     application.   "
27655|NCT02923752|"     This is a new vessel wall imaging-based stroke registry which will investigate the clinical     utility of the whole-brain intracranial vessel wall Magnetic Resonance Imaging (MRI)     technique in assessing the etiologies in patients with ischemic stroke.   "
27656|NCT02923739|"     The goal of this clinical research study is to learn if adding emactuzumab to the combination     of paclitaxel and bevacizumab can help to control relapsed or refractory ovarian, fallopian     tube, or primary peritoneal cancer. The safety and side effects of this drug combination will     also be studied.   "
27658|NCT02923700|"     Platelet-rich Plasma (PRP) is the most exploited biologic agents currently used for the     treatment of osteoarthritis (OA) of different joints, in particular knee OA.      In previous studies, it has been showed its potential to reduce pain and improve functional     status in patients treated by simple intra-articular injections. However, there are several     PRP formulation currently available in clinical use, and therefore it is very difficult to     compare data coming from trials using different products. The most debated aspect concerning     PRP formulation is the role of leukocytes, which might stimulate an early inflammatory     response in the joint due to the release of metalloproteases and other pro-inflammatory     cytokines.      The investigators hypothesized that the presence of leukocytes in PRP could be clinically     relevant in terms of outcome, so the present double blind randomized controlled trial was     designed to compare leukocyte-rich and leukocyte-poor PRP injections for the treatment of     knee OA.      A power analysis has been performed for the primary endpoint of IKDC (International Knee     Documentation Committee) subjective score improvement at the 12-month follow-up for PRP. From     a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a     beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding     at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group.     Considering a possible drop out of 15%, 96 patients per group are required for total 192     patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria'     section). Patients are then assigned to two different treatment groups, according to a     randomization list. The first group of treatment consists of three weekly intra-articular     injections of autologous leukocyte-rich PRP, whereas the second group of patients will be     treated by three intra-articular injections of leukocyte-poor PRP.      PRP will be obtained with the following procedure: a 300-ml autologous venous blood sample     will undergo 2 centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes,     and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of     leukocyte-rich PRP. In case of patients allocated to receive leukocyte-poor PRP, a special     filter will be then used to separate leukocytes and obtain leukocyte-poor PRP.      The total amount of PRP will be divided into 4 small units of 5 ml each. One unit is sent to     the laboratory for analysis of platelet concentration and for a quality test, 3 units are     stored at -30° C.      One week after the PRP production, the injective treatment starts, with 3 weekly injections.     At the moment of the injection the syringe is properly covered to prevent the patient from     discovering the substance he was receiving. After the injection, patients are sent home with     instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on the     affected area to relieve pain. During this period, the use of non-steroidal medication is     forbidden.      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using     clinical subjective scores and objective parameters to determine clinical outcome (see     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.     All the clinical evaluations are performed by a medical staff not involved in the injective     procedure, in order to keep the study double blinded. At the end of the study, the nature of     the injected substance is revealed to the patients.   "
27659|NCT02923687|"     Objective: The aim of this study is to evaluate premedication with ketorolac infiltration on     post endodontic pain in patients with symptomatic irreversible pulpitis.      Design: Randomized double blind clinical trial      Setting and conduct: Sixty adult volunteers with including criteria will be divided into two     groups (n=30) based on random table. All patients will receive standard inferior alveolar     nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of     0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes one group will receive     supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and the control group     will receive buccal infiltration of normal saline. Endodontic access preparation will     initiate after 15 minutes of initial IANB with two negative responses to the electric pulp     test. The pain level will be recorded immediately and at the 2,4,6 and 24 hours following the     treatment using Heft- Parker Visual Analog Scale (HP- VAS). Data will be evaluated using     Repeated measured test (if possible) and otherwise non-parametric tests such as rival     Friedman and X2 test. Participants including major eligibility criteria: all patients age     ranged 18-65 with symptomatic irreversible pulpitis (HP VAS ≥54) and without pain on     percussion on a mandibular molar tooth who need root canal treatment and are without systemic     diseases; nonsmoking; non pregnant, non breast feeding without any medicine consumption or     analgesic and sedation      Intervention: Ketorolac infiltration      Main outcome measures: Pain level at immediately after the treatment, 2, 4, 6 and 24 hours     following the root canal treatment using HP VAS.   "
27660|NCT02923674|"     This study will help determine the appropriate type, amount and intensity of physical     activity most beneficial for preventing weight regain after weight loss in older adults.   "
27773|NCT02922218|"     Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer     Treated With Enzalutamide (PROSENZA).   "
32938|NCT02854618|"     This study evaluates the immune response for patients affected by metastatic breast cancer     treated by everolimus   "
27661|NCT02923661|"     this study was conducted to clarify the effect of two different attachments on patient     satisfaction and marginal bone loss. The primary and secondary objectives are to determine     patient satisfaction and the marginal bone loss around implant when using CM LOC compared to     conventional ball attachment. all the patients will receive a single median implant to which     the denture will be loaded upon using the two different attachment systems   "
27662|NCT02923648|"     Obstructive lung disease is an increasing global health problem of pandemic proportions, with     COPD alone affecting >10% of the population. Smoking is the main and most well studies risk     factor for developing COPD. However, chronic airway obstruction also in never-smoking     populations has recently been recognized as an increasing health problem. Prematurely born     children, particularly survivors of bronchopulmonary dysplasia (BPD), defined as the need for     oxygen therapy up to the 28th day of life for children born prior to gestational week 32,     have an increased incidence of both airway obstruction and hyper-reactivity, both     representing major risk factors for developing COPD, or asthma, later in life. The purpose of     this study is to perform in-depth clinical and molecular characterizations of of the lungs of     survivors of BPD as they enter adulthood, and compare these profiles to relevant control     groups (individuals with mild asthma, healthy prematurely born, and healthy individuals born     at full term). Specifically, alterations at the epigenetic, mRNA, microRNA, protein and     metabolite level as well as associated molecular pathways critical in the pathological     mechanisms of obstructive lung disease related to premature birth and BPD will be identified.   "
27663|NCT02923635|"     The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and     its impact on patient satisfaction.   "
27664|NCT02923622|"     Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy     extensively in China, no strong evidence exists to demonstrate the safety and survival     outcomes of TCM herbal therapy combined with conventional western medicine for treatment of     this disease. The purpose of this multi-center perspective cohort study is to evaluate the     relationship between TCM herbal therapy and survival outcomes in patients with advanced     colorectal cancer.   "
27685|NCT02923349|"     The purpose of this study is to determine the safety and tolerability and assess preliminary     efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.   "
27670|NCT02923544|"     The purpose of this study is to test the feasibility and safety of using a new device called     Yukio's Uterine Manipulating Instrument (YUMI). The YUMI is a type of uterine manipulator. It     is a reusable metal device designed to be simple and study. It is also adjustable in size     which makes it easy for surgeons to use. It will be placed at the beginning of the surgery     and removed at the end. This study will allow the researchers to find out if the surgeons     find the YUMI effective and easy to use. It will also allow the researchers to see if the     device is safe. This is the first time that the YUMI is being used in humans.   "
27671|NCT02923531|"     The purpose of this study is to determine if the combination of X4P-001 plus nivolumab is     safe and tolerable. Secondly, the study will investigate if adding X4P-001 to nivolumab     treatment has an effect on the body and the cancer tumor, in patients receiving nivolumab but     not exhibiting a radiological response.   "
27672|NCT02923518|"     In 2010 there was published new European recommendations for assessment of adult and elderly     men and women, who want to start with physical activity and/or participate in endurance     contests. In this study we want to test if a group of people with positive score on a     self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have     more undetected heart diseases than a control group with no reported or detected risk     factors.   "
27673|NCT02923505|"     The aim of the study is to test the hypothesis that treatment of sleep disordered breathing     (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart     failure (HF) with positive airway pressure (PAP) is associated with reduced risk for     hospitalizations and death, lower health care utilization, and greater cost-effectiveness.   "
27675|NCT02923479|"     The purpose of this trial is to determine the effectiveness, safety and tolerability of     robot-assisted rehabilitation using ARBOT in patients with ankle dysfunction resulting from     work related ankle fractures, compared with conventional rehabilitation programs.   "
27676|NCT02923466|"     This is a Phase 1 multi-center study designed to determine the maximum tolerated dose (MTD)     and toxicity of intratumoral administration of VSV-IFNβ-NIS in patients with refractory     advanced/metastatic solid tumors.   "
27677|NCT02923453|"     Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in     patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A     total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover     design, the participants are randomized to receive either placebo or American ginseng extract     (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment.     Following ≥4-week washout period the participants are crossed over to another 8-week     treatment arm. Throughout the study period, all individuals maintain their original diabetes     treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting     blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety     parameters include liver, kidney and hemostatic functions.   "
27678|NCT02923440|"     Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000     newborns per year. The south-east region of France is particularly affected as a result of a     higher birth rate and consanguinity, when compared to other regions. The majority of     congenital heart diseases remain unexplained. Genetic causes are indisputable but remain     poorly understood. Genetic research needs the availability of a large-scale DNA collection,     guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris     (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a     bank is currently unavailable in south-east France. To transport biological specimens from     Marseille to Paris would be very expensive. In addition, the whole infrastructure required     for correct diagnosis and classification of the congenital heart diseases, for sampling, for     storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU     research unit. For those reasons it is highly preferable to elaborate such a database and     DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this     DNA-bank   "
27680|NCT02923414|"     Atrial fibrillation is the most common heart rhythm disorder. For patients suffering atrial     fibrillation direct current cardioversion is performed to reduce patients symptoms and     prevent disease progression. The optimal energy selection for biphasic cardioversion is     unknown.      We aim to investigate the efficiency and safety of a high energy shock protocol (360 J)     versus a standard escalating shock protocol (125-150-200 J) in cardioversion of atrial     fibrillation.   "
27681|NCT02923401|"     The goal of this research study is to learn if there is a level of exercise training that is     more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers     are found in the blood/tissue and may be related to your reaction to exercise.   "
27682|NCT02923388|"     This study will be conducted to evaluate the effect of vitamin B12 and vitamin B6 in delaying     the onset and reducing the incidence and severity of Vincristine Induced Peripheral     Neuropathy (VIPN) in Acute Lymphoblastic Leukemia (ALL) patient.   "
27683|NCT02923375|"     The purpose of this study is to assess the safety, tolerability and efficacy of two infusions     of CYP-001 in adults with steroid-resistant GvHD.   "
27684|NCT02923362|"     Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal     reflux disease and hiatal hernia.   "
27687|NCT02923323|"     Study population : 90 Participants. 60 with T1DM , and 30 healthy controls. T1DM patients     will be recruited by research publication in diabetes mellitus forums.      Baseline visit: informed consent signing. Medical history data, vital signs, physical exam     and neurocognitive testing. Capillary glucose prior to testing > 70 mg/dl.      Session 2 - combined simultaneous EEG , continuous glucose monitor system (CGMS) assessment,     neurocognitive testing, and sleep quality assessment.      Participants will be hospitalized for 30 hours in the continuous-EEG unit at the Pediatric     Neurology Department, Assaf-Harofeh Medical Center. Continuous simultaneous EEG and CGMS     monitoring, and two separate sessions of neurocognitive assessments at glucose > 240 mg/dl     and at glucose < 180 mg/dl, respectively.      Neurocognitive assessment will be performed after lunch on day 1, and after lunch on day 2.     Day 1, regular insulin dose before lunch, and a cognitive assessment which will be performed     with glucose level > 70 mg/dl and below 180 mg/dl.      On day 2, with no regular insulin dose before lunch and the same cognitive test will be     performed with glucose level > 240 mg/dl During the 30 hours the participants will be     connected to continuous EEG recording, sleep monitoring and CGMS. The study participants and     research team will be blinded to the EEG and CGMS readings while recorded.      Participants will be able to convey their daily activities in their room. They will have     their regular diet and regular daily activities.      Participants will measure at least 4 blood glucose measurements by prick tests, insulin     management by multiple daily injections or pump therapy and meals.      Healthy participants will measure twice daily as required for CGMS calibration. The     participants will stay connected to the CGMS for additional 4 days at their home setting for     complete sleep quality assessment by sleep diary and actigraph.      The first night in hospital is to assess the association between actigraph and EEG and CGMS     variability. The 4 nights at home are for assessment of CGMS, quality of life and actigraph     readings.      Control group (healthy) will perform only one session of neurocognitive studies on day 1,     after lunch with no insulin injection and will be discharged after 24 hours, with the CGMS     and actigraph   "
27688|NCT02923310|"     OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of     cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte     formation and synovial inflammation. Although the causes of OA are still poorly understood,     biomechanical stresses able to reach the articular cartilage and subchondral bone,     biochemical changes in cartilage and synovial membrane, as well as genetic factors are     important items in its pathogenesis. Although there is no cure for OA, treatment is directed     to each individual patient, seeking to minimize pain, maintain or improve joint range of     motion and limit disability. New therapies able to accelerate regeneration and tissue repair     process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been     shown to be an effective and safe treatment alternative in the fight against knee OA, in     addition to HA, worth highlighting the therapeutic effects of growth factors derived from     autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy,     non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to     evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and     PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild,     moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the     procedures and randomly assigned randomly. In PRP be determined concentrations of the growth     factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\. Functional evaluations will be     conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of     self-reported life. The walking and strength test will be performed before and during periods     of 90.180 and 360 days after the first application. The main motivation for the development     of this study is the lack of randomized, double-blind clinical studies in the literature, and     also based on the favorable results researchers have obtained, both with the use of HA, as     the use of PRP in accelerating the process scar, preventing the development of arthrosis     above. Therefore, we believe that the PRP, with its growth factors associated with synthetic     HA play a synergistic action that should be studied in detail, in order to establish an     effective therapeutic approach in the treatment of patients with knee OA.   "
27689|NCT02923297|"     Parkinson's disease (PD) is the most frequent neurodegenerative disorder after Alzheimer's     disease. It is characterized by motor symptoms (rigidity, tremor, slowness of movements), and     non-motor symptoms (neuropsychological, psychiatric, pain ...). Neuronal death initiates in     the brainstem and extends progressively through the entire cortex. The processes leading to     cell death are poorly understood. Pathological cells exhibit abnormal deposits, called Lewy     bodies, which contain numerous proteins. A major constituent of these protein deposits is     alpha-synuclein. It has recently been demonstrated, in the Laboratory of Molecular Biophysics     of the CNRS (Scientific Research National Center) in Orleans, that α-synuclein interacts with     Cytogaligin, a protein produced by the proapoptotic GALIG gene. Cytogaligin could thus be a     factor regulating α-synuclein activity or aggregation. It is postulated that the level of     expression of the GALIG gene is different in Parkinson's disease patients compared with     control subjects.   "
27690|NCT02923284|"     The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of     pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia,     ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on     identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable     low-cost screening method at the point of service. If successful, our method would provide a     diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need     to surgically remove a kidney with a benign tumor.   "
27691|NCT02923271|"     Research participants and their parents will be recruited to take part in a randomized     control trial. Participants' and their parents' cellphone use will be observed during an     initial baseline period. Participants and their parents will then be randomly assigned to one     of two conditions: opt-out blocking with parental notification, opt-out blocking with     bidirectional notification.   "
27692|NCT02923258|"     This is a randomized,controled, phase III, open label study of postoperative concurrent     chemoradiotherapy with Docetaxel versus Cisplatinum for high-risk squamous cell carcinoma of     the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and     safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.   "
27774|NCT02922205|"     The purpose of this observational study is to evaluate the safety and performance of the     Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic     Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be     achieved by assessing the device performance and reporting of peri- and postoperative     complications in a prospectively maintained database.   "
27693|NCT02923245|"     The purpose of this study is to assess the accuracy and utility of point-of-care ultrasound     (POCUS) of the bladder compared to patient's sensation of bladder fullness in predicting the     ability to successfully perform a comprehensive transabdominal pelvic ultrasound in the     pediatric Emergency Department (ED). We hypothesize that POCUS can more accurately and more     quickly determine adequate bladder fullness to successfully perform transabdominal pelvic     ultrasound than patient's perception of bladder fullness.   "
27694|NCT02923232|"     Presbyopes (people who might have a significant loss of their ability to accommodate their     crystalline lens in the eye) will be recruited to wear a test lens and perform typical     clinical tests of visual acuity with different luminance levels and viewing distances/angles.   "
27695|NCT02923219|"     The purpose of this study is to determine whether the adipose-derived stem cells therapy is     effective in the treatment of facial rejuvenation.   "
27696|NCT02923206|"     This clinical investigation is a medical device trial to examine the safety and efficacy of     TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.   "
27697|NCT02923193|"     Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind,     randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard     balloon angioplasty used in combination with DCB to treat moderate and severely calcified     femoropopliteal arteries. Assuming that roughly 15% of the subjects will be     lost-to-follow-up, a total of 334 subjects (167 per treatment arm) will be enrolled in the     study.   "
27700|NCT02923154|"     The purpose of this study is to investigate the efficacy, safety, tolerability and     pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.   "
27701|NCT02923141|"     The Purpose of this study is to see if it is possible to deliver an intervention that targets     trauma, substance use, and engagement in HIV care with HIV-positive women.   "
27702|NCT02923128|"     The purpose of this study is to determine whether postoperative analgesia pump continuous     infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and     Postoperative cognitive dysfunction.   "
27703|NCT02923115|"     This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic     Research Organization ARO and Clinical Research Organization CRO blinded),     placebo-controlled, randomized, single-ascending dose, multi-center study to assess the     safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in     subjects with acute submassive pulmonary embolism.   "
27704|NCT02923102|"     The aim of the study is to investigate a pre and post workout supplementation (15 days) with     Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects     will be investigated with 400mg Recoverben® and compared to placebo.   "
27705|NCT02923089|"     This study will recruit 20 healthy adults (male and female) to complete 9 study visits where     they will consume different food products (chili, soup and muffin) with or without lentils     incorporated into the them. Blood samples will be obtained by finger prick before and for 2     hours after the meal and analyzed for glucose and insulin.   "
27706|NCT02923076|"     Allogeneic hematopoietic cell transplantation from a CCR5 Δ32/Δ32 unrelated donor, performed     for the first time in the Berlin patient, provides the only evidence to date of long-term     control of HIV infection. Stringent criteria to select human leukocyte antigen (HLA)-matched     conventional donors and low prevalence of the CCR5 Δ32/Δ32 homozygous genotype (<1%) made the     pursuit of patient number 2 unsuccessful for many years. Cord blood (CB) transplantation     allows more permissive HLA-matching criteria, making the search for HLA-compatible Δ32/Δ32 CB     units potentially feasible for transplantation of HIV-infected individuals.      The investigator team involved in this trial has recently reported the first such case of     CCR5 delta32/delta32 CB transplantation in a patient with HIV infection, showing a reduction     of the patient's latent viral reservoir and, upon achievement of full CB chimerism,     resistance of his CD4 T-lymphocytes to infection by HIV. This proof of concept led the     Spanish National Transplant Organization (ONT) to generate an inventory of over 150 CCR5     Δ32/Δ32 CB units readily available for transplant.      From this initial evidence and repository of CB units, financial support from the Fundación     Mutua Madrileña (FMM) has allowed the investigators to launch this first pilot clinical trial     in this indication. The study was launched in January 2016 at Hospital Universitario Puerta     de Hierro Majadahonda. All HIV virology and reservoir analyses are carried out by the AIDS     Immunopathology Unit at the Spanish Instituto de Salud Carlos III. Three additional     transplant centres in Spain will also shortly open the trial.   "
27707|NCT02923063|"     Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of     CKD with substantial adverse clinical consequences of disability, hospitalization, and death.     Sarcopenia in this proposal is defined by impaired metabolism and physical function     associated with decreased skeletal muscle mass or function. Skeletal muscle tissue relies on     mitochondria to efficiently utilize oxygen to generate ATP. Impaired mitochondrial energetics     is a central mechanism of sarcopenia in CKD. The investigators propose a series of studies     designed to shed light on the pathophysiology of sarcopenia in persons with CKD not treated     with dialysis. Investigators will conduct a randomized-controlled intervention trial of     combined resistance training and aerobic exercise vs. health education to assess changes in     skeletal muscle mitochondrial function, metabolism and physical function. Investigators     hypothesize that exercise improves mitochondrial function and physical function in persons     with CKD. If successful, these experiments will identify novel pathophysiologic mechanisms     for CKD-associated sarcopenia. The proposed study will provide useful insight into benefits     associated with exercise among patients with CKD and investigate mechanisms associated with     improved metabolism, muscle function and physical function in population.   "
27708|NCT02923050|"     The purpose of this study is to determine effectiveness of a family meals intervention,     Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight     status.   "
27709|NCT02923037|"     This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in     breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast     cancer survivors with lymphedema as they directly support lymph transport (postures,     breathing, relaxation) and emotional well-being (relaxation, meditation).   "
32939|NCT02854605|"     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in     participants with nonalcoholic steatohepatitis (NASH).   "
27710|NCT02923024|"     Oscar spends a significant amount of money every year on high cost high need individuals.     With this increase in health care spending, Oscar Health is looking to expand care post     emergency room and inpatient utilization for their members. In order to reduce hospital     readmissions, reduce emergency room utilization, and increase the overall health of their     members, Oscar is investing in a program to bring members better care through increased     engagement with their primary care physician.   "
27711|NCT02923011|"     Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males     between ages 10 and 20 years. The goal of the proposed study is based on the premise that     MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain     reduction following treatment of osteoid osteomas, and offers possible improvements with     regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience,     and/or 4) adverse events. The data from the current study would provide clinicians important     information in deciding between treatment options for ablation of osteoid osteomas.   "
27713|NCT02922985|"     Opioid use and abuse has become a major medical problem in the United States. Over     prescription of opioid medications is a major contributor to this growing problem. Cesarean     delivery (CD) is the most commonly performed surgery in the US and women are generally given     opioid medications for postoperative pain management. This is not a common practice in other     developed countries. The investigators believe that a multimodal pain management strategy is     superior to current practices for control of postoperative pain after CD and will lead to a     decrease in the use of opioid medications. This will have beneficial effects on patients'     recovery and bonding with their newborns, as well as societal effects in reducing the burden     of opioid abuse in the US. The objective is to investigate the use of a multimodal pain     regimen in pregnant patients undergoing CD. This is a randomized double-blinded, placebo     controlled trial. The multimodal intervention consists of a pre-operative dose of intravenous     (IV) acetaminophen (Ofirmev), infiltration of subcutaneous bupivacaine prior to skin     incision, and a dose of intramuscular (IM) ketorolac at time of fascia closure. These study     medications are currently used in the patient population but not in a standardized fashion,     not in every patient, and not always in combination with each other. The control group will     receive placebo IV infusion preoperatively and an IM injection at fascia closure, and     subcutaneous infiltration with normal saline before skin incision. Both groups will receive     spinal regional anesthesia as per anesthesia team. Post-operatively, both groups will receive     the current standard of care, which consists postoperative hydrocodone/acetaminophen and     ibuprofen as needed depending on pain score. The primary outcome of interest will be the     total opioid intake in the first 48 hours after surgery. Secondary outcomes include time to     first opioid requested, pain scores at 6-12, 24 and 48 hours post op, and total number of     opioid tablets left after discharge on post op day number 7. Additional outcomes include     patient satisfaction scores and total length of hospital stay. The hypothesis is that our     multimodal pain regimen will decrease the total opioid requirement in the first 48 hours     after surgery.   "
27714|NCT02922972|"     The aim of this prospective study is to assess the efficacy of autologous Platelet Rich     Plasma prepared with RegenKit-BCT in the prevention and the treatment of keloid scars     refractory to conventional treatments. Fifteen patients were included and received three PRP     injection sessions with a one-month interval. The outcomes were assessed at baseline (before     treatment), 3, 6, 12 and 24 months after the last injection session. Safety was assessed by     reported adverse event analysis.   "
27715|NCT02922959|"     This project will further develop and test the Tailored Telephone Intervention delivered by     Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention     to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a     non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO     (NCT02282306) found that the participating patients and the Peer Interventionists were     satisfied with their participation, the intervention was acceptable, and the system for     generating patient-tailored intervention information performed well. The overall goal of the     present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control     group. It is hypothesized that patients in the TTIP-PRO group will have more favorable     drug-abuse-related outcomes than patients in the control group.   "
27716|NCT02922946|"     The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal     on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability     of entinostat under fed and fasting conditions in healthy adult subjects.   "
27717|NCT02922933|"     The purpose of this study is therefore to evaluate the effect of concomitant drugs known to     affect solubility of drugs through increase of intra-gastric pH levels on the bioavailability     of entinostat.      The primary objectives of this study are to evaluate the effect of multiple doses of     omeprazole, famotidine, and the effect of an acidic beverage on the single-dose PK profile of     entinostat.      The secondary objectives are to evaluate the safety and tolerability of a single dose of     entinostat when administered with multiple doses of omeprazole, famotidine, and when     administered with an acidic beverage.   "
27718|NCT02922920|"     Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert     anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about     the effects of drinking tart cherry juice on cardiovascular and cognitive health.   "
27719|NCT02922907|"     Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation     for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.   "
27720|NCT02922894|"     This study will investigate potential therapeutic approaches for sleep-disordered breathing     (SDB) in patients with chronic cervical spine injury (>6 months post-injury).   "
27721|NCT02922881|"     Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has     long been considered to be due to a dysregulated immune response targeting the colon, and     involves unknown environmental factors. Currently, no effective therapy targets the     microbiota or its interaction with the colonic epithelium. Diet has a significant impact on     the composition of the microbiota; however, no dietary intervention to date has proven     effective for induction of remission. The primary objective of this study is to determine     whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC     patients with active mild to moderate UC on a stable medication.   "
27722|NCT02922868|"     The purpose of this research study is to compare the effectiveness and efficiency of using a     sterile sheath (EndoSheath®) during cystoscopy versus a standard scope.   "
27723|NCT02922855|"     A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6     months of enrollment in a health care coverage program. Study subjects are drawn from a     low-income adult population that gains coverage and access to community-based primary care     services under a program administered by an academic safety-net hospital. The investigators     will offer financial incentives to encourage an initial primary care visit within 6 months of     enrollment and evaluate whether the primary care visit altered subsequent health seeking     behavior and influenced patient satisfaction and other outcomes such as self-reported health     status.   "
27724|NCT02922842|"     The purpose of the study is to compare patient centered- outcomes between Transcutaneous     Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence.     One of these locations will be along the tibial nerve, which is traditionally accessed near     the medial malleolus. The second site will be on the sacral nerve which is accessed over the     sacrum. The third site will be a sham site on the shoulder. This study will evaluate the     feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.   "
27725|NCT02922829|"     The Prenatal Nutrition and Psychosocial Health Outcomes (PreNAPS) study was a two year     collaboration between Gulu, Makarere, Cornell, and Tufts Universities. The PreNAPs study's     primary goals were: a) to determine the differential impacts of food insecurity on     gestational weight gain and prenatal depression, and b) to elucidate the mechanisms     underlying the relationship between food insecurity and weight gain and/depression among HIV     infected and HIV uninfected pregnant women in Gulu, Northern Uganda.   "
27726|NCT02922816|"     Transplant patients are at increased risk of colonization and infection with Multidrug     Resistant Organisms (MDROs) due to medications that modify their immune systems, increased     healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study,     kidney transplant patients who have infections with resistant bacteria will be given a Fecal     Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic     treatment. This study will see if FMT will eliminate the resistant bacteria so that the     kidney transplant patients do not have to use last resort antibiotics.      This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant     patients to support the rationale for a subsequent clinical trial, not to establish efficacy     or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes,     assess feasibility, and refine the target population in participants with MDRO colonization     and intestinal dysbiosis. Data from this study should provide directions for the design of     future clinical trials.   "
27727|NCT02922803|"     Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th     parallel were observed to be weak and to have a waddling gate.      Study 1 was carried out in the setting of an antenatal clinic administered from a primary     care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in     Sweden. The investigators chose an initial study period in late spring to reflect the effects     of the dark season with little ultraviolet B radiation that affects vitamin D production.     Study 1 was carried out in a short period of time. The recruitment was performed in a     retrospective design in order to neglect the seasonal effects of ultraviolet B radiation.     Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels     of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123     pregnant and new mothers from Somalia (n=52) and Sweden (n=71).      Study 2: Examines the results on muscular performance, i.e. grip strength and squatting     ability, from intervention with advice and prescription of vitamin D3 and calcium for 10     months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD.      Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery     outcome in birth protocols starting 2016.      Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and     strength in the group of Somali women by focus interviews among the Somali women from above.      A possible fifth study will explore correlations between 25-OHD and pain distribution and     pain parameters.   "
27728|NCT02922790|"     The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid)     damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes cessation.   "
27729|NCT02922777|"     This study is being done to evaluate the safety of the investigational study drug, BGB324     when administered in combination with docetaxel, and to establish the maximum tolerated dose.   "
27730|NCT02922764|"     Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of     RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR,     resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor     blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from     attacking tumors.      During the dose escalation stage, multiple doses and schedules of orally administered RGX-104     will be evaluated in patients with advanced solid tumors and lymphoma (i.e., locally advanced     and unresectable, or metastatic) who have had progressive disease (PD) on available standard     systemic therapies or for which there are no standard systemic therapies of relevant impact.     In the expansion stage of the study, additional patients with melanoma, non-small cell lung     cancer, epithelial ovarian carcinoma, or breast cancer will be treated at the MTD (or maximum     tested dose if no MTD is identified, or dose below the MTD if there is evidence suggesting a     more favorable risk/benefit profile) to provide further characterization of RGX-104 safety,     efficacy, PK, and pharmacodynamics, including biomarkers of immunologic activity and LXR     target activation.   "
27731|NCT02922751|"     Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of     pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic     evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and     risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and     quantify liver fibrosis.   "
27732|NCT02922738|"     Health care providers use a variety of computerized medical information sources to reduce     knowledge gaps and support patient care decisions. Few studies have evaluated the impact of     medical information sources on patient outcomes. Skin problems are the reason for many visits     to primary care providers and result in a high percentage of referrals to dermatologists and     return visits to primary care for the same skin problem.      The objective is to evaluate the impact of primary care providers' use of a dermatology     information source, VisualDx, on skin problems outcomes.      The study design is a cluster-randomized controlled trial. Participants include primary care     providers as clusters and their patients with skin problems. Providers are randomized to     intervention group that refers to VisualDx when seeing a patient with a skin problem, or to     the control group who does not. Patients have the randomized group status of the doctor they     saw for the problem.      Patients are interviewed to determine the problem status and how many follow-up visits they     had for the problem at intervals after the index visit.   "
27733|NCT02922725|"     The investigators propose to determine if 8 weeks of dietary augmentation with oral 5g     creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (5-HTP) twice daily reduces     hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale     (HAM-D) in women with SSRI- or SNRI-resistant depression, combined with the examination of     changes in functional connectivity based on resting-state fMRI and changes in brain     metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.   "
27734|NCT02922712|"     Study is conducted to evaluate safety and efficacy in patients with osteoarthritis   "
27735|NCT02922699|"     Comparison of efficacy of H.pylori eradication during first line therapy using standard or     high doses of omeprazole administered twice daily in combination with amoxicillin and     clarithromycin for 10 days.   "
27887|NCT02920710|"     There is a need for a more reliable, expeditious therapy that can be used as an alternative     to glucocorticoids in severe Central Nervous System (CNS) sarcoidosis. This study aims to     provide evidence for effectiveness of ACTHAR gel in CNS sarcoidosis, and provide information     about its safety and tolerability   "
27736|NCT02922686|"     The main objective of this study is to investigate the non-inferiority of oral flucloxacillin     alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the     emergency department directed outpatient treatment of cellulitis, wound infections and     abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin     and skin structure infections (ABSSSIs). Half of the trial participants will receive     flucloxacillin and placebo in combination, and the remaining half will be treated will     flucloxacillin and phenoxymethylpenicillin.      In a secondary objective the trial aims to measure adherence and persistence of trial     patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the     cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin     compared with combination therapy from the perspective of the health-care payer (direct     costs) the patient and government. Finally the study will externally validate the Extremity     Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed     to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in     clinical trials.   "
27737|NCT02922673|"     Rationale:      The last years, research focus has moved to immunostimulatory agents in order to restore or     increase the functionality of the immune system during sepsis-induced immunoparalysis.     Epidemiologic data show that prehospital use of low dose acetylsalicylic acid (ASA) is     associated with improved outcome of sepsis. Experimental data indicate that ASA exerts     pro-inflammatory effects during systemic inflammation. However, it remains to be determined     whether treatment with ASA improves immune function once immunoparalysis has developed and     whether prehospital use of low dose ASA prevents the development of immunoparalysis. In the     former case, ASA is a potential immunostimulatory therapy that can treat sepsis-induced     immunoparalysis. In the latter case, ASA may have a broader indication as an immunomodulating     agent. Taken together, ASA might be a promising, cheap, well-known, and globally available     agent to reduce the incidence of secondary infections and improve patient outcome in sepsis.      Objective:        -  To determine whether acetylsalicylic acid treatment can reverse endotoxin tolerance,          which is expressed as a decrease in pro-inflammatory cytokine levels between the first          and second endotoxin challenge.        -  To determine whether acetylsalicylic acid prophylaxis can prevent endotoxin tolerance,          which is expressed as a decrease in pro-inflammatory cytokine levels between the first          and second endotoxin challenge.      Study design:      Double-blind randomized placebo-controlled pilot study in 30 healthy male volunteers during     repeated experimental endotoxemia. All subjects will receive a 14 day course of study     medication (low-dose ASA or placebo) and undergo experimental endotoxemia (lipopolysacharide     (LPS), E.Coli type O113) on day 7 and on day 14. LPS is administrated using an initial bolus     of 1ng/kg followed by continuous infusion at 1ng/kg/hr during 3 hours.      Subjects are randomized in three study arms:        1. Treatment group: 7 days placebo / first endotoxemia / 7 days ASA 80 mg (loading dose on          first day of 160mg) / second endotoxemia        2. Prophylaxis group: 7 days ASA 80 mg (loading dose on first day of 160mg) / first          endotoxemia / 7 days ASA 80 mg / second endotoxemia        3. Placebo group: 7 days placebo / first endotoxemia / 7 days placebo / second endotoxemia   "
27738|NCT02922660|"     This is a single-center, randomized, prospective research which aims to investigate the     advantages and disadvantages between desflurane balanced anesthesia and TIVA-TCI with     propofol in ophthalmic ambulatory surgery, so that to evaluate a better anesthesia method in     ophthalmic surgery through a large sample clinical study.   "
27739|NCT02922647|"     The urpose of this study is to compare the urinary tract infection rate on the four     postoperative day between the 2 groups of patients who have undergone total mesorectal     excision for cancer and low anastomosis, with either suprapubic or transurethral     catheterization.   "
27740|NCT02922634|"     The objectives of this study are to determine whether identifying patients with baseline     cognitive deficits through preoperative cognitive screening may aid patient, family, and     surgeon decision-making; inform and potentially improve anesthetic management and improve     patient safety by identifying risk for postoperative morbidity.      Aim 1. Assess the marginal benefit of structured preoperative cognitive screening relative to     standard or systematic preoperative evaluation for identifying seniors with likely cognitive     impairment.      Aim 2. Determine whether preoperative cognitive impairment predicts postoperative outcome.   "
27741|NCT02921581|"     Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in     intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also     apply for recurrent and second primary head and neck cancers in previously irradiated     volumes. This trial (RIDPAINT) investigates the feasibility of FDG-PET guided radiotherapy     using IMRT dose-painting by contours for patients with recurrent and second primary head and     neck cancer.   "
27742|NCT02921568|"     This study is designed to evaluate and compare in-tissue performance of OCT scans on the new     Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.   "
27743|NCT02922608|"     High fidelity simulation provide educational skills but the simulation of critical events     could eventually provide anxiety among participants.      The anxiety could raise before the simulation session and affect the perceived quality of     sleep the night prior to the simulation session. The lack of sleep would eventually affect     both participation and memorization during the simulation session. The investigators would     like to investigate with a survey how much participants had their sleep affected before the     simulation session.   "
27744|NCT02922595|"     The primary purpose of this study is to compare with a non-inferiority randomised study the     new laryngeal tube (Intubating Laryngeal Tube Single-Disposable - iLTS-D) to the     well-established Intubating Larygeal Mask Airway (ILMA/ Fastrach) for the success rate and     time for intubation under fiberoptic control. Secondary purposes are success rates and times     for ventilation for both devices and finally success rate of gastric tube placement.   "
27745|NCT02922582|"     This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects     scheduled to undergo total knee arthroplasty (TKA).   "
27746|NCT02922569|"     This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess     the safety and efficacy of an experimental software program designed to improve cognitive     functions versus a computer-based software control. Both the study and the software being     investigated meet the criteria of Non-Significant Risk. The primary objective of this study     is to evaluate the effects of combination of mindfulness training (MT) and adaptive cognitive     training (CT) on the cognitive abilities, functional status and quality of life of soldiers     and veterans diagnosed with traumatic brain injury (TBI, also referred to as a concussion, or     blast exposure), as compared to a computer-based control.   "
27747|NCT02922556|"     To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for     depression (Moodify) versus an active control treatment (commercially available computer     games).   "
27888|NCT02920697|"     The purpose of this study is to determine the safety profile and tolerability of S 55746 in     patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum     Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile     (DLT, MTD), PK profile, PD profile and preliminary efficacy.   "
27748|NCT02922543|"     To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as     Revlimid) in patients with relapsed or refractory multiple myeloma (hereinafter referred to     as relapsed or refractory MM) who have received long-term treatment with it under the     actual condition of use.        1. Planned registration period This period started on the date of initial marketing of          Revlimid and will end at the time when the planned number of patients to be enrolled,          300, is reached (estimated to be approximately 1 year and 3 moths).        2. Planned surveillance period This period started on the date of initial marketing of          Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid          (estimated to be approximately 4 years and 3 months).   "
27749|NCT02922530|"     The overall goal of this research proposal is to develop an adjunct to standard treatments     that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly     treating these core deficits via targeted behavioral training should slow the progression of     PD, assure greater resilience against future decline, and improve the quality of life of many     living with PD. The purpose of this exploratory research study is to determine the benefits,     if any, of the mobile device-based treatment described above in individuals with PD.   "
27750|NCT02922517|"     Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)   "
27751|NCT02922504|"     A surgical abortion under local anesthesia is potentially painful. A protocol using analgetic     is systematically used. Also the protocol is relevant , the question of taking care of the     pain in a safe manner remains.      The use of Music during surgery can have a real effect on pain and anxiety. This study has     for goal to evalued the use of music on pain as adjuvant treatement instead of a standard     care for an abortion.   "
27752|NCT02922491|"     It is a study of clinical and interventional character, in which individuals who participate     in the intervention will be selected for convenience of the project database entitled Second     Cycle Diagnosis and Intervention Food Situation, Nutrition and Noncommunicable Disease More     Prevalent Population of the city of João Pessoa / PB . They will be invited to participate     in the intervention female subjects, overweight or obese, aged 20 and 59 years. The selected     individuals will be distributed randomly into three groups: receive daily supplementation of     01 capsules containing 400 mg of vitamin E synthetic source (Group 1); receive daily     supplementation of 01 capsules containing 400 mg of natural source vitamin E (Group 2); and     receive daily supplementation of 01 placebo capsule (control group). Individuals of all     groups will receive dietary plan respecting individual needs, in order to control weight     during the 08 weeks period. This project aims to evaluate whether vitamin E supplementation     may modify the methylation and microRNAs profile.   "
27753|NCT02922478|"     This study aims to create a database of patients with stable and chronic heart failure with     comprehensive assessment of bone, skeletal and vascular status. RoC-HF will facilitate     cross-sectional and, eventually, longitudinal mechanistic epidemiological analyses to     disentangle the role of the bone- vascular axis in chronic heart failure. Blood and urine     samples will be stored to facilitate future biomarker analyses.   "
27754|NCT02922465|"     The primary objective of this study is to assess the effects of clopidogrel on the PK of     K-877 in healthy adult subjects.   "
27755|NCT02922452|"     This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with     parameters like Cmax, AUC(INF), and AUC(0-T).   "
27756|NCT02922439|"     The purpose of this study will to be to evaluate the effects of a mobile intervention focused     on improving the chronic disease self management skills of individuals with low health     literacy. The intervention will provide information that culturally and linguistically     tailored to participants' level of health literacy.   "
27757|NCT02922426|"     This study will characterize insulin sensitivity in response to treatment with ALKS 3831,     olanzapine, and placebo.   "
27758|NCT02922413|"     The purpose of this study is to determine if Panhematin is safe and effective for prevention     of acute attacks of porphyria.      The study aims to provide high quality evidence for the use on hemin for prevention of acute     attacks of porphyria. A separate study is in progress to evaluate the use of Panhematin for     treatment of acute attacks of porphyria. Such studies have not been done previously for     treating or preventing acute attacks with hemin. The lack of strong evidence for efficacy of     hemin for treatment and prevention of attacks limits its availability for patients with acute     porphyrias.   "
27759|NCT02922400|"     The primary objective of this study is to determine the efficacy and feasibility of a battery     of neuropsychological measures evaluating social cognition and behavior in young adults     diagnosed with schizophrenia, autism spectrum disorders, or traumatic brain injury (TBI). It     also investigates functional differences in regions of the brain associated with social     cognition and differences in cognitive processing. Additionally, this study implements a     virtual reality intervention to strengthen social cognition skills.   "
27787|NCT02922036|"     This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal     trial to study the safety and efficacy of the WiSE-LV System for Cardiac Re-synchronization     Therapy.   "
27760|NCT02922387|"     Prospective, open-label, parallel-group, 52-week trial comparing varenicline in combination     with behavioral support with one session of behavioral support alone.      Eligible patients were smokers hospitalized due to a) acute exacerbation of chronic     obstructive pulmonary disease (COPD), or b) bronchial asthma attack, or c) community-acquired     pneumonia (CAP).      The primary outcome was the success rate (%) at week 52. Secondary outcomes were quality of     life (QoL) alterations on the domains of the 36-Item Short Form Health Survey (SF36) and     investigation of possible predictors for smoking abstinence.   "
27761|NCT02922374|"     For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the     first-line treatment in the guideline, but patients have a great risk of requiring colectomy     or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative     colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids,     and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an     alternative to UCEIS.   "
27762|NCT02922361|"     This project will use data from a large network-model health maintenance organization that     operates Medicare Advantage (MA) plans (CareMore) and fee-for-service Medicare data to (1)     better understand the characteristics of high-need, high-cost MA enrollees patients and (2)     evaluate the impact of a care management program focused on high-need high-cost MA enrollees     with end-stage renal disease.   "
27763|NCT02922348|"     The investigators intend to establish feasibility/acceptability of a pilot randomized trial     comparing hormone replacement therapy (HRT) and combined oral contraceptives (COCs) in women     with premature ovarian insufficiency to estimate differences in quality of life (QOL) and     serum hormone assays and markers of bone turnover/cardiovascular risk. At baseline, QOL     survey will be administered and serum testing performed. Patients then randomized to HRT or     COCs. Repeat testing will be performed after 3 and 6 months.   "
27764|NCT02922335|"     This study's purpose is to test the effectiveness of a promising intervention for emerging     adults (EAs) with mental illness (MI) and serious antisocial behavior in achieving the     ultimate outcome of reduced antisocial behavior, and proximal intermediate outcomes.     Multisystemic Therapy-Emerging Adults (MST-EA) is an adaptation of MST, a well-established,     effective intervention for antisocial behavior in adolescents.   "
27765|NCT02922322|"     To analyze the effectiveness of mat Pilates compared to no intervention in individuals with     chronic nonspecific low back pain.   "
27766|NCT02922309|"     People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal     training in order to improve communication efficiency and quality of life. However,     participation in vocal training of elderly is often restricted by motivation, time of     practice, and availability to hospital, which thus reduces treatment effects. The purpose of     the study is to design a telecommunication vocal training system and a vocal training program     for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study,     including a single-blind, randomized controlled trial, to test the hypothesis that vocal     training via telepractice for voice disordered elderly are not inferior to the standard face     to face training.   "
27767|NCT02922296|"     The purpose of the study is to better understand how the body handles sugars glucose and     fats, such as cholesterol and triglycerides in sickle cell disease, and what puts certain     persons at risk to develop diabetes. This understanding may help us to find new treatments to     control blood sugar and prevent diabetes in people with and without sickle cell disease     (SCD).      In this research, DNA and RNA will be isolated from blood cells. DNA will be used to find     genes that cause or protect from diabetes, high cholesterol and high triglyceride, and RNA     will be used for studies designed to find out how genes are doing their job of eventually     producing proteins.   "
27768|NCT02922283|"     T cell infiltration of tumor lesions is a known prognostic factor in several tumor types and     is used as treatment mechanism in some of these tumor types. In metastatic melanoma,     treatment with immune checkpoint inhibitors induces clinical benefit in about 30-50% of the     patients. These immune-based therapies are however accompanied by serious immune-related     adverse events and high costs.      Tumor infiltrating T cells express the high affinity interleukin-2 (IL2) receptor on their     surface. These T cells could therefore be visualized by molecular imaging with a     radio-labelled ligand for this receptor. For this purpose, the investigators have developed     the PET tracer [18F]FB-IL2.      The study commences with a biodistribution study (phase 1) in 5 subjects. Thereafter the main     study (phase 2) starts, in which 25 subjects will receive two [18F]FB-IL2 PET scans at     baseline and week 6 of treatment with either ipilimumab, nivolumab, pembrolizumab or the     combination of ipilimumab and nivolumab. If [18F]FB-IL2 PET is able to detect a response to     treatment, it could serve as a non-invasive early indicator of T cell response to the     treatment. Besides, accumulation of the PET tracer in non-target tissue could indicate     infiltration of activated T cells in normal organs and thus may predict the development of an     immune-related adverse event.   "
27769|NCT02922270|"     INTRODUCTION AND AIMS: The aims of this study were to evaluate patient and technique survival     rates, investigate peritonitis rates and evaluate factors affecting mortality in peritoneal     dialysis (PD) patients over a period of 20 years at Istanbul Faculty of Medicine Peritoneal     Dialysis Unit.      METHODS: Two hundred seventy seven patients have received PD as renal replacement therapy     (RRT) over a period of 20 years. After exclusion of patients with follow-up shorter than 3     months and patients whose data were not available, 250 patients were examined     retrospectively. Data for sex, age, primary disease, comorbidities, follow up duration, cause     of death, and cause of technique failure were collected from medical records.   "
27770|NCT02922257|"     This study will investigate the potential for FK506 binding protein 5 (FKBP5) (and other gene     expression markers, for example pentraxin 3 [PTX-3], serum/glucocorticoid regulated kinase 1     [SGK1], and glycogen synthase kinase 3 beta [GSK3b]) to be developed as a biomarker for use     in diagnosis of Cushing's syndrome, assessment of effectiveness of medical or surgical     treatment, and detection of relapse of endogenous Cushing's syndrome after surgery.   "
27771|NCT02922244|"     The herbal products on reduction of radiation-induced dermatitis in patients with breast     cancer   "
27772|NCT02922231|"     Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South     Korea.      Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal     clinical care in South Korea.   "
27775|NCT02922192|"     Purpose:      With the existing biologic anti-inflammatory product patents expiring and the FDA approval of     new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic     (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options.     This observational study will describe the patient characteristics of new users of Tumor     Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic     agents. It will describe in the treatment cohorts outcomes of serious infections that require     hospitalization. The BBCIC will use the findings from this descriptive analysis to design a     comparative study evaluating the real-world effectiveness and safety of biosimilar and     innovator anti-inflammatory biologics.   "
27776|NCT02922179|"     Over the past 40 years, new types of insulins have been marketed to mirror the effect of     endogenous insulin. With the existing long-acting insulin product patents expiring and the     FDA approval of new biosimilar and innovator insulins, adults with diabetes and their     physicians will have additional therapeutic options. This observational study will describe     the patient characteristics of new and existing users of long-acting or intermediate acting     insulins with and without oral anti-diabetic agents (OAD) as well as acute hypoglycemic     episodes, acute cardiac events, and A1C measures. The Biologic and Biosimilars Collective     Intelligence Consortium (BBCIC) will use the findings from this descriptive analysis to     design a comparative study evaluating the real-world effectiveness and safety of biosimilar     and innovator insulins.   "
27777|NCT02922166|"     To determine the effects of SRX246 on fear and anxiety based on fear-potentiated startle in     humans. Additionally, the effects of the compound on emotion recognition will be explored.   "
27778|NCT02922153|"     The investigators propose to assess whether intra-operative intercostal cryoanalgesia using     the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior     post-operative analgesic efficacy as compared to current pain management in patients     undergoing unilateral thoracotomy cardiac procedures.   "
27779|NCT02922140|"     This study aims to investigate the role of clinical pharmacist in the development of a     pharmaceutical care program for patients with Acute coronary syndrome tailored to their     specific learning needs and their cultural context, and to verify the program's effects on     physiological factors and recurrent symptoms or cardiac events.   "
27780|NCT02922127|"     Breast cancer accounts for almost a quarter of all cancers in women. In the United States     (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer.     There is an urgent need to develop acceptable means of preventing breast cancer both for high     risk and average risk women.      The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the     capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation     (increase in number of cells in the breast) and to measure its effect compared to that found     with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use     as daily medication up to 12 months for the treatment of abnormally heavy bleeding at     menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its     use as a daily contraceptive.      The investigators will use breast biopsies to compare breast cell proliferation, comparing     biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA     and COC). The investigators will also compare the changes in the 2 groups to each other. The     comparison of the effect of UPA to that of a conventional COC is because of UPA's potential     use as a daily contraceptive.      Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of     hormones on the breast are rapid and an anti-progestin such as UPA, which will block the     action of progesterone in the breast, would be predicted to quickly lower breast cell     proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and     are reassuring. COC use has not been found to lower breast cell proliferation and is not     associated with any decrease in risk of breast cancer.      The changes in breast cell proliferation will also be compared to changes seen on breast MRI.     If the changes are highly correlated future studies will be able to be done without the need     for breast biopsies.   "
27781|NCT02922114|"     Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates     to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and     sensitive tool for joint assessment. Published studies showed US joint abnormalities in     systemic lupus erythematosus patients with or without joint pain. Nevertheless,     ultrasonography evaluations were not standardized and no study compared clinical and     ultrasonography assessments. The objectives were 1) to describe ultrasonography joint     abnormalities in systemic lupus erythematosus population, 2) to compare clinical and     ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical     swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and     ultrasonography-SLEDAI.   "
27782|NCT02922101|"     This study evaluates the addition of a quality improvement toolbox to an online audit and     feedback intervention in Dutch intensive care units. The toolbox comprises for each quality     indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential     bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for     measuring pain every shift), associated recommendations for actions to solve mentioned     bottlenecks (e.g., organize an educational training session), and supporting materials to     facilitate implementation of the actions (e.g., a slide show presentation discussing the     importance and relevance of measuring pain every shift). Half of the participating intensive     care units will only receive online feedback, while the other half will additionally gain     access to the integrated toolbox to facilitate planning and executing actions.   "
27783|NCT02922088|"     The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose     vascular grafts have been treated with DuraGraft. All participating sites will be from     countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and     post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes     and patient reported quality of life over a period of 5 years.   "
27784|NCT02922075|"     This study evaluates the impact of soft tissue grafts on soft tissue recession following     immediate implant, provisional and bone graft placement in compromised sockets. One third of     the patients received a collagen matrix (CM group), another third received a connective     tissue graft removed from the palate (CTG group) and the final third did not receive any soft     tissue graft (CTL group).   "
27785|NCT02922062|"     The purpose of this study is to determine the effects of palm oil when consumed as either     part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular     health and inflammation. The study will help us better understand how the quality of     saturated fat and the quantity of carbohydrate interact to impact blood lipids and     cardiovascular health.   "
27786|NCT02922049|"     To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness     analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting     persistent/recurrent IM, recurrent neoplasia and buried glands.   "
27788|NCT02922023|"     In this study, investigators will compare chronotherapy to ABPM. Data collected will include     hypertension drug therapy regimen prior to and during the study, timing of medication     administration, and dose, along with the patient's office blood pressure values prior to     study and one month after modification in therapy. This will enable us to explore whether it     is a practical endeavor to implement ABPM as a routine process for all uncontrolled     hypertension patients or whether ABPM does not seem to provide considerable value over     shifting the timing of drug administration.   "
27789|NCT02922010|"     The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral     hygiene practices of women who participated in a randomized controlled trial (2011001) at     University of Alabama Birmingham during the period 2012-2014. Additional objectives of the     research include evaluation of possible cultural, biological or other mechanisms for outcomes     observed in the OHMOM clinical trial, and oral health screening of children born to mothers     during the study for the purposes of understanding possible multigenerational effects of oral     hygiene education.   "
27790|NCT02921997|"     This is a single center, randomized, partially-blinded, Phase II, small, targeted,     prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18     to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an     intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without     AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v     virus vaccine. The primary objectives include assessing the serum anti-HA     hemagglutination-inhibition (HAI) response to influenza A, identifying differentially     expressed genes in human immune cells, and identifying differentially abundant cellular     proteins in human immune cells.   "
27791|NCT02921984|"     The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary     gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and     safety of customized CCT regimens based on the gene targets of SGTs.   "
27792|NCT02921971|"     Primary Objective:      To evaluate, in comparison with placebo, the efficacy of SAR156597 administered     subcutaneously for 24 weeks on skin fibrosis in patients with dcSSc.      Secondary Objectives:        -  To evaluate the efficacy of SAR156597 compared to placebo on physical/functional          disability in patients with dcSSc.        -  To evaluate the efficacy of SAR156597 compared to placebo on respiratory function in          patients with dcSSc.        -  To evaluate the safety profile of SAR156597 compared to placebo in patients with dcSSc.        -  To evaluate the potential for immunogenicity (anti-drug antibodies [ADA] response) of          SAR156597 in patients with dcSSc.        -  To evaluate the pharmacokinetics (PK) (trough plasma concentrations) of SAR156597          administered subcutaneously for 24 weeks.   "
27793|NCT02921958|"     Data was collected from Parents of children who were receiving occupational therapy services.     Three assessment tools were used: 1. Life Participation for Parents, 2. Infant Toddler     Sensory Profile, and 3) Child Behavior Checklist. Data was used to pursue 2 investigations.        1. Is the Life Participation for Parents responsive to change after intervention?        2. Are there correlations between child behavior, child sensory processing, and parental          participation in their own lives while raising a child with special needs.   "
27794|NCT02921945|"     In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is     being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A.     These subjects will receive open label treatment with SCT800 for approximately 6 months for     on-demand treatment.   "
27795|NCT02921932|"     This study aims to study the efficacy of a preoperative bundle of interventions, which     consists of preoperative physiotherapy, nutritional support and cognitive exercises on     elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes.     There will be two arms, intervention and control.   "
27796|NCT02921919|"     This is a single-arm, open-label, extended treatment, safety study in patients treated with     talazoparib in qualifying studies.   "
27797|NCT02921906|"     Neonatal diabetes is diagnosed before 6 months of age and causes high blood glucose levels     due to the pancreas not secreting insulin. Neonatal diabetes can be caused by a change in a     DNA region called the KCNJ11 gene. KCNJ11 encodes a channel in the pancreas that acts as a     switch to turn 'on' and 'off' insulin secretion. A change in KCNJ11 results in a faulty     channel, which keeps insulin secretion 'switched off'. The diabetes can be treated with     tablets called sulphonylureas that switch the pancreatic channel 'on', allowing it to secrete     insulin in response to gut hormones called incretins. Previous research has shown that     patients who switch from insulin to sulphonylureas have better blood glucose control,     including fewer episodes of hypoglycaemia (glucose dropping too low), and also avoid the need     for injections. It is thought that serious side effects from sulphonylureas are uncommon in     KCNJ11 neonatal diabetes. Some patients report low glucose after meals and we think this may     be because they make too much insulin if they eat a meal with protein but low amounts of     carbohydrate. The investigators will test this by giving study participants different meals     and measuring the amount of insulin, glucose and incretin hormone in the blood afterwards.   "
27798|NCT02921893|"     This pilot clinical trial studies how well ixazomib citrate, lenalidomide, and dexamethasone     work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal     gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in     treating patients with POEMS syndrome.   "
27799|NCT02921880|"     The aim of this pilot study is to assess function, independence, frailty and emotional status     in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at     4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac     rehabilitation programme and the remaining 15 patients will receive standard of care. All     patients will return to clinic at 3 months and 6 months post implant and undertake the     functional, independence, frailty and emotional testing again.   "
28329|NCT02914886|"     The purpose of this study is to investigate whether a zinc-free insulin is an effective     treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump     (CSII, continuous subcutaneous insulin infusion) therapy.   "
27801|NCT02921854|"     In this exploratory study, the investigators will investigate if markers (molecular and     immunological) of ICD or anti-tumor immunity (exosomal or molecular) can be detected in the     serum of patients after high-dose radiotherapy alone or concurrent cisplatin-doublet therapy     and radiotherapy. For each patient: withdraw blood at three times during treatment for     analysis.   "
27802|NCT02921841|"     Teenagers in mental health treatment are at greater risk for HIV and other sexually     transmitted infections. This greater risk comes from many factors, some of which are related     to poor emotion regulation and low self-confidence. There is a need for an HIV prevention     program specifically for these at-risk teens. The goal of this study is to develop a     computerized HIV prevention study tailored to adolescents in mental health treatment. The     first part of the study will develop core sessions of D*STAR. It will do this by using focus     group feedback from approximately 15 adolescents in mental health treatment, and     approximately 10 parents of youth in mental health treatment and mental health treatment     center staff. Feedback on D*STAR prototype sessions will also be collected from two     individual interviews with approximately 15 youth in mental health treatment. Core sessions     will then be reviewed in an open trial with approximately 30 adolescents.      The second part of the study will develop and refine digital versions of the remaining     sessions of STAR and a digital general health promotion intervention. It will do this by     using focus group feedback from approximately 20 adolescents in mental health treatment, and     approximately 10 community advisory board members which include variety of staff from mental     health treatment settings such as administrators, supervisors, therapists, health teachers at     therapeutic schools, clinicians at day hospitals and day treatment programs, parents of youth     in mental health treatment and from relevant community organizations, such as those serving     lesbian, gay, bisexual, transgender, and questioning youth. Feedback on D*STAR prototype     sessions will also be collected from two individual interviews with approximately 20 youth in     mental health treatment. All developed sessions (from both Phase I and Phase II) will then be     reviewed in an open trial with approximately 20 adolescents. A randomized control trial (RCT)     will then be conducted to compare D*STAR to a time matched digital general health promotion     intervention among approximately 120 adolescents. For the pilot and RCT phases, assessments     will be administered prior to randomization, immediately following the last intervention     session, and at one month post-intervention (pilot study) or at three month post-intervention     (RCT).   "
27803|NCT02921828|"     1. Planned enrollment period One year (The planned number of patients to be enrolled is set          to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in          RevMate®, enrollment using the Registration Form of the surveillance will be completed          at the time when the planned number of patients to be enrolled is reached. During a          period until conditions for approval are removed, a system enabling to retrospectively          collect appropriate information based on patient data from RevMate® will be, as          necessary, maintained.        2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the          start date of release of Pomalyst   "
27804|NCT02921815|"     To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute     myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with     myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to     as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and     who are continuing or no longer continuing Revlimid treatment.        1. Planned registration period This period started on the date of initial marketing of          Revlimid and will end on the day when the appropriateness of enrollment is assessed for          all del(5qMDS) patients in the all-case surveillance.        2. Planned surveillance period This period started on the date of initial marketing of          Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.   "
27805|NCT02921802|"     To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as     Revlimid) in all patients who are treated with it under the actual condition of use pursuant     to the conditions of approval.        1. Planned registration period This period started on the date of initial marketing of          Revlimid and will end at the time when the planned number of patients to be enrolled is          reached.        2. Planned surveillance period This period started on the date of initial marketing of          Revlimid and will end on the day when the approval condition related to all-case          surveillance is terminated.   "
27806|NCT02921789|"     The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab     induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC)     regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the     prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) defined as nephrotic range     proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant.     Death, graft loss or lost to follow-up will be imputed as rFSGS.   "
27807|NCT02921776|"     This Phase II Small Business Technology Transfer Research (STTR) will deliver a comprehensive     patient communication solution for communication-impaired patients in the intensive care unit     that may help decrease days in delirium, decrease anxiety levels, and reduce sedation     exposure which are proximal outcomes known to be associated with decreased mechanical     ventilation days, shorter lengths of ICU and hospital stay, and lower healthcare cost. The     primary goal of this Phase II STTR proposal is to further define user requirements and     product specifications and develop a prototype of VidaTalk, a patient-centric, touch pad     communication software, to provide mechanically ventilated (MV) patients an evidence-based     solution for effectively communicating their needs to care providers and family. A secondary     goal is to test the impact of the VidaTalk on clinical outcomes. This study will use mixed     methods including observations and interaction with hospitalized patients as they use the     VidaTalk tool, surveys and medical record data extraction, product evaluation and brief     interview, satisfaction surveys with family members of ICU patients, and focus groups with     Registered Nurses.      Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual and     customizable messages, compatibility with tablet devices, picture symbols, and integration     with mobile communication devices.      Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical     setting.      Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV     patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3     hypothesis: MV patients using VidaTalk will demonstrate significant reductions in     patient-reported communication difficulty and frustration, anxiety, sedation exposure,     delirium/coma-free days, and improved patient and family satisfaction with ICU care compared     to MV patients receiving attention-control (i.e., tablets with health education application).   "
27808|NCT02921763|"     This survey is intended to collect efficacy and safety data of Duphaston® Tablets in patients     with endometriosis under actual condition of its use and to obtain data for effectively and     safely utilizing this drug.   "
27810|NCT02921737|"     This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to     evaluate the activity of TAS-102 in previously treated metastatic and locally advanced     unresectable pancreatic cancer after progression through or intolerance to first line     chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally     twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint is     to determine the progression free survival (PFS) in subjects with unresectable pancreatic     adenocarcinoma.   "
27863|NCT02921022|"     The purpose of this study is to test any good and bad effects of the study drug called     PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA)     has not approved the marketing or sale of PEGPH20, but have authorized its use in research     studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects.     PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced     by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of     hyaluronan from tumors may decrease tumor growth.   "
27811|NCT02921724|"     This is a prospective testing-validation, interventional, non-pharmacological study on a new     app for oral anticancer therapy management.      A total of 80 patients will be considered: 20 evaluable patients in the training step; 60     patients in the validation step. In the training step will be considered evaluable the     patients with: at least 6 weeks of treatment; visit at 6 weeks after the start of treatment     performed and questionnaires self-administered.      Patients will be visited every 6 weeks. In the training step, patients will remain under     observation for a minimum of 6 weeks, until change of therapy (due to progression of disease,     unacceptable toxicity, death, discontinuation) or for a maximum of 12 weeks. Patients     enrolled in the validation step will remain under observation until change of therapy (due to     progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 24     weeks.      The objective of this study is to assess the capability of a newly developed interactive     health care application to support patients and health professionals in the shared management     of oral anticancer therapies, improving adherence, preventing complications at home,     toxicities, improper treatment reductions or interruptions, emergency accesses and to assess     the system usability and acceptability by patients and health professionals, integration in     the hospital workflow, monitoring over time patient perceived levels of quality of care,     quality of life, social support, anxiety, and self-care capability.   "
27812|NCT02921711|"     A prospective, multicenter, observational assessment of the safety and effectiveness of the     LVIS® device in the treatment of wide necked intracranial aneurysms.   "
27814|NCT02921685|"     This study will determine the Maximal Tolerated Dose if any and the recommended dose for     phase 2 of monalizumab, a monoclonal antibody directed against the CD94/NKG2A receptor, after     allogenic stem cell transplantation. All patients will receive one single intravenous     administration of one of the four doses of monalizumab.   "
27815|NCT02921672|"     By doing this study, researchers hope to learn if older adults with and without cognitive     impairment can adhere to a Mediterranean diet.   "
27816|NCT02921659|"     The purpose of this study is to assess the efficacy of supplementation with the Nicotinamide     Adenine Dinucleotide (NAD+) precursor compound, Nicotinamide Riboside (NR), for improving     physiological function (vascular, motor, and cognitive) in healthy middle-aged and older     adults.   "
27817|NCT02921646|"     The purpose of this study is to determine whether evolution of resting energetic expenditure     is a predictive marker of tumoral response for patients suffering from metastatic pancreatic     cancer and treated with 1st line of chemotherapy.   "
27818|NCT02921633|"     This study will investigate whether behaviourally informed changes to the invitation process     can improve uptake of childhood influenza vaccine by two and three year olds at primary care.   "
27819|NCT02921620|"     The study will be a randomized, double blind, placebo-controlled study of the safety and     efficacy of PRX-102 in ERT naïve male patients randomized 1:1. Patient age will be 14 to 45     years. Patients must have diarrhea defined as ≥ 3 stools a day with an average consistency of     ≥ 5.5 on the Bristol Stool Form Scale (BSFS) by patient electronic diary and moderate to     severe gastrointestinal symptoms as defined by the Irritable Bowel Symptom Severity Score     (IBSSS) Part 1 average > 175 derived from at least two IBSSS assessments during screening     period. Patients will receive intravenous infusions of PRX-102 1 mg/kg or placebo every two     weeks for 6 months.   "
27820|NCT02921607|"     The goal is to define a set of clinical pathways for heart failure patients, reflecting the     period from prior to admission to the post-discharge period following hospitalisation, under     the current system that exists at the two clinical sites [as mentioned previously, the main     site is at St Vincent's University Hospital in Dublin, but to ensure generalizability the     project team will also carry out similar work Portsmouth Hospital, United Kingdom]. These     pathways have been drawn up using the experience of the clinical investigators, using an     interactive workshop approach and a pilot study.        1. Pre-Admission Pathway        2. Emergency Department Pathway        3. In-Hospital management Pathway        4. Pre-discharge Pathway        5. Post-Discharge Pathway      During identification of these pathways, the research team identified the settings/personnel     that require study to more fully comprehend the methods, strengths and weaknesses of the     present processes. Study activities are focused on two aspects of the patient journey,     immediately before discharge and three months post discharge during the outpatient phase.   "
27821|NCT02921594|"     Primary: The primary objective of this pilot study is to compare the intraarticular     kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.      Secondary: The secondary objective of this pilot study is to compare the standing balance by     force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR     prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both     groups.   "
27822|NCT02921555|"     The purpose of this study is to determine the efficacy of high-dose corticosteroid pulses     added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.   "
27823|NCT02921542|"     To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a     predetermined laser treatment protocol in patients presenting with varying lesion types or     morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous     (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of     calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment)     associated with peripheral arterial disease (PAD).   "
27824|NCT02921529|"     The purpose of this study is to observe the effects of transcutaneous electrical acupoint     stimulation(TEAS) on postoperative recovery after colon surgery.   "
27825|NCT02921516|"     Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle     income countries, both have risen among youth. In addition, HIV-infected youth achieve     inferior treatment outcomes compared to their adult counterparts in both high- and low-income     countries, and these poorer outcomes are generally attributed to suboptimal adherence. Thus,     there is a critical need for the development of adherence and risk reduction interventions     for the growing cohort of these youth, and the proposed cognitive behavioral N'ap Grandi is     one such intervention.   "
28186|NCT02916784|"     1. Were there differences in functional ability between ambulatory individuals with SCI who          passed and failed the independent sit-to-stand (iSTS) task?        2. Did the ability of iSTS relate to ability of walking as determined using a type of AAD          used?        3. What were factors associated with the ability of iSTS?   "
27827|NCT02921490|"     Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost     wages, etc) annually. The most common source is low back pain (LBP), often from facet joints.     The clinical evaluation of facet joints is challenging and anatomic imaging findings of facet     joint; degenerative change; correlate poorly with pain. Therefore, it is difficult to select     appropriate candidate patients/facet joints to treat. Misguided percutaneous treatment can     cost thousands of dollars per session and delay diagnoses. Very limited retrospective     information suggests that high grade peri-facet MRI signal change correlates to the side of     LBP. However, this has not fully characterized the imaging findings and has not correlated to     expert clinical exam/percutaneous response, precluding robust and meaningful clinical impact.     Minimal retrospective data concludes inflammatory changes can be identified on FDG-PET exams,     but the evidence of correlation to patient pain is lacking. Limited DWI exists for     inflammatory spondyloarthropathies and myopathies, but is also lacking.      This is an exploratory study investigating the utility of FDG PET activity and MRI signal     change around facet joints in the clinical management of low back pain. This study will help     determine if such imaging biomarkers could change clinical management. Additionally, this     will provide data that will be vital to planning a larger prospective study evaluating the     ability of imaging biomarkers to predict response to comparison medial branch blocks and RF     ablation for treatment of facet joint pain.   "
27828|NCT02921477|"     The present study is designed as an open label study of patients with mild cognitive     impairment or dementia to evaluate longer term tolerability and potential efficacy of     tyrosine kinase inhibitors. Baseline and outcome measures in this study utilize validated     tests that are appropriate for repeated measures which are not affected by practice effects.     Advantages of this study include the fact that the neuropsychological testing instruments and     advanced MRI imaging protocols that have been in routine clinical deployment provide for a     high degree of availability and reliability for diagnosis and for monitoring change of     status. Quality assurance is tightly controlled. The study population is sufficiently broad     and the conditions of interest are sufficiently prevalent so that recruitment of the     projected numbers of subjects is not a limiting factor.      For a Phase I trial there is a proposed 20 patient sample to determine the frequency of     common side effects in the population that is being studied. Subjects will be administered     the initial dose of bosutinib, with dosage progressively increased over the course of the     study. The initial dose of bosutinib is 100 mg tablet, once per day. The dose will be     increased as tolerated up to 300 mg per day.      All subjects will be started at 100 mg/day and the dose will be increased by 100 mg each     month if the lower dose is tolerated without significant side effects. That is to say, the     subject will take 100 mg/day every day for the first month, 200 mg/day every day for the     second month, and 300 mg/day every day for the third month and for the remainder of the     study, provided that adverse reactions do not prohibit continuation at this dosage. The     investigators will be using the Common Terminology Criteria for Adverse Events (CTCAE)     Version 4.0 to monitor, evaluate, and report adverse reactions on an ongoing basis. Stopping     and dose reduction rules for reported adverse reactions have been taken from the package     insert of bosutinib.   "
27829|NCT02921464|"     Florida Cardiovascular Quality Network Application of Clinical Decision Support Software     Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality     Outcomes Registry   "
27830|NCT02921451|"     The purpose of this study is to determine the long term performance of Restorelle system for     the treatment of uterine prolapse.   "
27831|NCT02921438|"     The study is a prospective multi-centre observational study to evaluate a portable     magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who     present to the emergency department with chest pain and other symptoms consistent with ACS.   "
27832|NCT02921425|"     This study was a pilot 3-month clinical trial that investigated the feasibility,     effectiveness, and acceptability of using the Track Health function of the Veterans Health     Administration's patient health record for effecting a more positive physical activity (PA)     and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with     prediabetes. Baseline and three-month post-intervention outcomes were measured in two main     domains: objective (e.g., weight) and subjective (e.g., self-efficacy).   "
27833|NCT02921412|"     This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month     dispensing study   "
27834|NCT02921399|"     After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H.     pylori) infection is advised to reduce metachronous recurrence. However, few studies have     addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none     have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the     investigators will conduct to evaluate whether differences in timing of eradication therapy     after ER of gastric tumors.   "
27835|NCT02921386|"     A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine     the effect of meals of various amounts of fat given immediately prior to dosing on the     pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will     be dosed for a 14 day run-in period. This will be followed by a randomized sequence of five     periods over a 6 day confinement period. Subjects will receive a randomly ordered sequence of     breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and a high fat     breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed     Bioequivalence Studies.   "
27864|NCT02921009|"     This study will investigate the effectiveness of fluence rates and treatment times of Corneal     Cross Linking other than the original FDA approved protocol of 3mw/cm2.   "
27865|NCT02920996|"     This research study is examining merestinib (a targeted therapy) as a possible treatment for     non-small cell lung cancer (NSCLC) that was found to have a specific change in the MET gene     (a MET exon 14 mutation); or as a treatment for solid tumors that have an alteration in the     NTRK gene (an NTRK1, 2, or 3 rearrangement).   "
27866|NCT02920983|"     This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and     omafilcon A II 2 daily disposable contact lenses.   "
27846|NCT02921243|"     In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or     schizoaffective disorder, investigators propose to conduct a prospective, 2 week     observational trial to collect gastrointestinal stool samples in order to characterize the     microbiota in people with schizophrenia and examine its variability over time. Participants     may elect to participate for an additional two weeks, during which they will receive the     prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the     relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators     will use an inpatient sample in order to standardize meals, exercise and environmental     mediators. This is considered a feasibility, pilot study in order to apply for future grant     funding. Investigators will recruit patients from the Treatment Research Program inpatient     unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.   "
27836|NCT02921373|"     Cell-based therapies in the form of stem cell-based or immune cell-based therapies are     becoming important treatment options that are either approved for clinical use or are showing     promise in clinical trials. One of the issues regarding cell-based therapies is that, once     the cells are injected into a subject, there is no easy way to track where they go, assess     whether adequate numbers of cells arrive at the intended therapeutic target and for how long     they persist at a given location. To address this issue non-invasive imaging methods have     been developed using magnetic resonance imaging (MRI). When used with an appropriate cell     labelling contrast agent, Cellular MRI can track cells non-invasively in vivo. Detection of     cells is accomplished with an inert imaging agent containing the MRI sensitive fluorine-19     (19F) nuclei. The objective of this study is to demonstrate that 19F-MRI is safe to use in     humans so that it can subsequently be used to track cell-based immunotherapies in future     clinical trials. The long term goal is to be able to quantify immune cell migration to     secondary lymphoid tissues and potentially to tumors and correlate to therapeutic outcomes.   "
27837|NCT02921360|"     The aim of this study is to determine whether early administration of aspirin in acute     ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes     due to decreasing the number of early rethromboses.   "
27838|NCT02921347|"     The aim of this study is to facilitate weaning by switching between invasive and noninvasive     ventilation in difficult-weaning patients.   "
27839|NCT02921334|"     The aim of this study is early tracheotomy to facilitate weaning by switching between     invasive and noninvasive ventilation.   "
27840|NCT02921321|"     Muscular Dystrophy can affect the skeletal muscles and also the heart and breathing muscles,     causing significant morbidity and mortality. As patients are now living longer, treatment of     muscular dystrophies involves drugs that help improve heart function. However, better types     of heart imaging studies are needed to understand how these treatments work. Researchers want     to improve heart imaging to identify earlier indicators of heart dysfunction in muscular     dystrophy patients and how these are changed by medical treatment. The new imaging indicators     will also help identify candidates for entry into future clinical trials.   "
27841|NCT02921308|"     Health Issue: Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common     complication of being born premature. Damage to the still developing lung stops the normal     formation of the alveoli. Young adults with a history of BPD have lower lung function, early     heart disease, and increased risk of death, compared to those without BPD. Recently, it has     been reported that they may also develop a type of lung disease typically seen in older     adults with a longstanding history of smoking. The severity of lung disease is usually     measured using pulmonary function tests (PFT), but these tests may be normal, even in the     presence of important changes in the fine structure of the lung. Such structural changes may     be early markers of future lung disease and can be detected using lung magnetic resonance     imaging (MRI). Unlike other ways of imaging the lungs, MRI does not expose people to harmful     X-rays. To date, no studies have been done to examine the fine structure of the lung of     school-aged children who had a history of BPD, to determine whether there are signs of lung     disease that might not otherwise be obvious. This is important because once armed with this     information, preventive measures can be taken to avoid worsening of lung disease.      Objective: 1) In 7-9 year-old children born extremely premature, lung MRI will be compared     between those with and without BPD. The Investigators expect to observe more severe     structural lung abnormalities in children with BPD, compared to those without BPD; 2) The     Investigators will test to see if children with more severe MRI abnormalities also have worse     lung function, and/or more symptoms of breathing problems. The Investigators expect to     observe more PFT abnormalities in children with BPD than in those without and that these will     match up with lung fine structure abnormalities identified on MRI.      How will work be undertaken? Children 7-9 years old who were born extremely prematurely will     be recruited to participate in this study. Participants will be identified from Neonatal     Follow-up clinics they attended. The Investigators will enroll 20 children with BPD and 20     without BPD. Participants will have lung MR images taken, during which they need to lie still     for a few minutes. PFT will also be performed, during which they will blow into a machine.     Parents will be asked to complete questionnaires about breathing problems, their living     conditions (environment) and any doctor visits or hospital stays. Medical charts will be     reviewed for information about their birth.      Unique/Innovative Aspects: This will be the first study using MRI as an innovative way to     visualize and measure fine structure of the lung in children born prematurely with and     without BPD. These findings may be early markers of lung disease, which would identify     children who have, or are at risk of developing lung disease later in life, for whom the     Investigators may be able to offer treatments now and/or prevent worsening of lung disease.   "
27842|NCT02921295|"     The purpose of this study is to compare the College Park Sidekicks to conventional stubby     prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity,     exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be     observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete     the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional     stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.   "
27843|NCT02921282|"     In this study, potential associations between several genetic polymorphisms and nicotine     dependence will be examined. The relative reinforcing efficacy of cigarettes using the     forced-choice procedure will be assessed. In addition, reactivity to smoking cues using a     reliable procedure will be conducted.   "
27844|NCT02921269|"     This phase II trial studies how well atezolizumab and bevacizumab work in treating patients     with cervical cancer that has come back, remains despite treatment, or has spread to other     places in the body. Monoclonal antibodies, such as atezolizumab and bevacizumab, may shrink     tumor cell and interfere with the ability of tumor cells to grow and spread.   "
27860|NCT02921061|"     This randomized phase I trial studies the side effects and best dose of decitabine when given     together with filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride in treating     patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed, has     come back, or has not responded to treatment. Drugs used in chemotherapy, such as decitabine,     cladribine, cytarabine, and mitoxantrone hydrochloride work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Colony-stimulating factors, such as filgrastim, may increase     the production of blood cells and may help the immune system recover from the side effects of     chemotherapy. Decitabine, filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride     may work better in treating patients with acute myeloid leukemia and myelodysplastic     syndrome.   "
27847|NCT02921230|"     The EMINENT study is a prospective, multi-center study confirming the superior effectiveness     of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in     the femoropopliteal arteries.   "
27848|NCT02921217|"     The study's main objective is to investigate if an extract containing the probiotic     Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the     accumulation of abdominal visceral fat in people with abdominal obesity.   "
28187|NCT02916771|"     This research study is evaluating a new drug called ixazomib as a possible treatment for     Smoldering Multiple Myeloma.   "
27849|NCT02921204|"     Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia.     Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are     thought to be at greater risk for vitamin D deficiency because of their darker skin type and     the likelihood of reduced ultraviolet exposure . The present study entitled, Dietary Intake     and Vitamin D Level in adult Women, was formulated as there is paucity of data on the     etiologic importance of dietary intake in Vitamin D level on blood on women. The major     objective of the proposed study is to assess the effect of dietary intake of nutrients and     level of vitamin D in women .   "
27850|NCT02921191|"     Purpose:      With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents     expiring and the FDA approval of new biosimilar and innovator biologics, patients being     treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional     therapeutic options. This observational study will describe the patient characteristics of     new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of     hospitalizations for febrile neutropenia. The BBCIC will use the findings from this     descriptive analysis to design a comparative study evaluating the real-world effectiveness     and safety of biosimilar and innovator G-CSFs.   "
27851|NCT02921178|"     The purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in     the propensity-matched group on asthma exacerbation in asthma patients in Korea: a     retrospective cohort in real world.      Omalizumab was approved 2007 in Korea and has been used in this center. We would like to     collect and analyze the data and exacerbation outcomes of these patients on Omalizumab; no     Korean real world data available.   "
27852|NCT02921165|"     The aim of this study is to determine the beneficial effect of mouth rinses, both topical     analgesic and saline regimens as an adjuvant therapy in the presence of standard prescription     of post-operative pain killers on the progress of socket healing following routine dental     extraction.   "
27853|NCT02921152|"     Operable early stage breast cancer patients staged according to NCCN guidelines are subjected     to bone marrow aspiration/trephine biopsy at the time of the definitive operation under     general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the     sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor     cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be     studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively.     Results of the pilot study will be evaluated as observational study.   "
27854|NCT02921139|"     Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in     treating hepatocellular carcinoma patients with unresectable intermediate stage. However,     residual viable HCC after TACE is not uncommon, leading to a poor overall survival after TACE     alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be     potentially useful for curatively managing early-stage HCC in retrospective studies. Thus,     conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE     residual tumors is therefore encouraged. The present phase-III trial intended to compare     clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with     post-prior-TACE residual tumors.   "
27855|NCT02921126|"     To quantify rates of bleeding events and investigate the characteristics of prescribed     patients, rates of bleeding events, persistence and healthcare resource utilization of Oral     Anticoagulants (OACs) prescribed in routine clinical practice.   "
27856|NCT02921113|"     Acute Kidney Injury(AKI) is of the serious complications in patients with undergoing on-pump     cardiac surgery. End stage kidney failure requiring dialysis therapy after cardiac surgery is     associated with more than 60% mortality rate. Involvement of AKI after on-pump cardiac     surgery increases the mortality rate 19 times. suPAR is one of the novel biomarker which has     potential prognostic value for renal dysfunction in patients with undergoing on-pump cardiac     surgery. Early diagnosis and prompt intervention to prevent AKI has great importance for     management of postoperative cardiac patients.   "
27857|NCT02921100|"     150 patients who had suspected pancreatic malignancy were planed to be enrolled in this     study. Equal cytological samples of each patient undergoing EUS-FNA were examined by digital     image analysis and conventional cytology respectively. The investigators aim to compare the     efficacy of DIA and conventional cytology in diagnosing pancreatic cancer. Further more, the     investigators also collected the blood sample of each enrolled patient for advanced study.   "
27858|NCT02921087|"     This study seeks to address whether or not different types of daily disposable soft contact     lenses may be a beneficial option for patients complaining of eye strain and visual     discomfort while using digital devices.   "
27859|NCT02921074|"     This study is a validation study to document the acceptability of the Tonic and Phasic     Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia.     The goal of this study is to employ a computerized attention-training program, TAPAT,     designed for chronic late-life insomnia in a randomized, controlled trial to assess     feasibility and initial efficacy in this population.   "
27871|NCT02920918|"     Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs     Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption [VO2])     and ventilator efficiency (minute ventilation [VE]/carbon dioxide production [VCO2] slope) at     cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints).     Blood pressure (BP), body water content, body composition, cardiac function, and diet will be     also measured (secondary endpoints).   "
27872|NCT02920905|"     The present clinical study will be undertaken to compare study between the effect of     atracurium with lidocaine versus addition of magnesium sulphate to the same doses with     lidocaine administrated alone in IntraVenous Regional Anaesthesia to access motor block,     sensory block, tourniquet pain and post operative analgesia .Also assessment of patient and     surgeon satisfaction .   "
27900|NCT02920541|"     The purpose of this study is to determine the safety profile and tolerability of S 055746 in     patients with AML, and high or very high risk MDS, in terms of Dose-Limiting Toxicities     (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D)     through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.   "
28188|NCT02916758|"     This study evaluates the program outcomes of the Let's Go program. The standardized community     mobility program employs multi-modal group and individual sessions to facilitate wellness in     older adults.   "
27873|NCT02920892|"     The overall goals are to change the paradigm for development of mechanism targeted     pharmacotherapy in neurodevelopmental disorders and provide a definitive test of the mGluR     theory in humans by determining whether AFQ056, an mGluR5 negative modulator, can enhance     neural plasticity in the form of language learning during an intensive language intervention     in very young children with fragile X syndrome. This trial therefore will use an innovative     but exploratory new trial design to develop a different way to examine efficacy of an agent     with substantial support as a drug targeting CNS plasticity in preclinical models of a     developmental disorder. If the design is successful, this trial can serve as a model for     future trials of mechanistically-targeted treatments operating on neural plasticity in other     neurodevelopmental disorders.   "
27874|NCT02920879|"     This study investigates airway effects of PEEP during maskventilation at anesthesia     induction. Four patient groups will be ventilated with different PEEP and driving pressures     to evaluate time to open airway after start of positive pressure maskventilation during     anesthesia induction.   "
27875|NCT02920866|"     This study plans to learn more about the effects of physical therapy (PT) following a total     hip arthroplasty (THA). The purpose of this study is to compare standard of care PT after THA     with a physical therapy program specifically designed to integrate targeted core and hip     muscle strength and functional training.   "
27876|NCT02920853|"     The purpose of this study is to assess whether a novel, enhanced form of biofeedback can help     individuals regulate their chronic musculoskeletal pain more effectively.   "
27877|NCT02920840|"     Combining TMS and EEG, this study investigates a personalized therapeutic non-invasive brain     stimulation protocol in patients with major depression, whereby the timing of the TMS pulses     is synchronized with the instantaneous phase of ongoing brain oscillations in order to     modulate the inter-hemispheric left and right dorso-lateral prefrontal cortical brain     network.   "
27878|NCT02920827|"     The proposed study is a single center, double-blind placebo-controlled trial to assess the     safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted     for 28 days in 16 healthy, HIV-negative women.   "
27879|NCT02920814|"     The aims of this project are to determine the effectiveness of a time intensive form of     Cognitive Behavioural Therapy (CBT) for Specific Phobia of Vomiting (SPOV). Current research     shows that this brief format can be effective in other specific phobias e.g. insects and     animals. However, to date limited research has been conducted on the effectiveness of time     intensive forms of CBT for SPOV. A single case experimental design will be used to analyse     specific and idiosyncratic outcome measures in 6-8 cases of SPOV, referred to the Centre for     Anxiety Disorders and Trauma (CADAT) for treatment. Specifically, the project will explore     the effectiveness of CBT delivered in a time-intensive format and imagery rescripting     elements of the treatment. This initial study will provide important information about which     elements of CBT are most effective at reducing targeted symptoms and whether symptom     reduction can be achieved in a shorter number of sessions. It represents a crucial step     before this format of CBT can be more rigorously evaluated and compared to other treatment     approaches by Randomised Controlled Trial.   "
27880|NCT02920801|"     In this study, the investigators aim to investigate whether saxagliptin modulate endothelial     progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2     diabetic patients.   "
27881|NCT02920788|"     One of the most pressing concerns within the VA currently is the provision of interventions     that address the cognitive as well as emotional problems faced by Veterans with mild TBI and     comorbid conditions. When completed, these studies will inform us whether training core     attentional self-regulatory control functions via personally-relevant activities will be     effective in improving daily life for Veterans with mild TBI and comorbid conditions. The     study design will provide a test not only of potential benefits for real life functioning,     but also determine to what extent these benefits are related to actual changes in     cognitive/behavioral performance and brain networks corresponding to these functions. This     project will provide a foundation for future studies to investigate the neural mechanisms     that support improvements of cognition and behavior in mTBI.   "
27882|NCT02920775|"     Changes in prescribing will be compared in prescribers from specialties whose prescribing is     hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice     providers) versus those for whom the REMS could have greater impact on prescribing (e.g.,     dentists). Trends and changes in monthly prescription volume and average monthly prescription     volume will be evaluated by prescriber specialty.   "
27883|NCT02920762|"     A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA     opioids   "
27884|NCT02920749|"     The purpose of this study is to compare the perioperative hemodynamic parameters, recovery     profiles and cost containment of sevoflurane and propofol based general anesthesia for     otorhinolaryngeal surgery.   "
27885|NCT02920736|"     The purpose of this study is to determine the value of urine sTREM-1 on early predicting     secondary acute kidney injury in sepsis   "
27886|NCT02920723|"     Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It     does multiply tenfold the occurrence of vascular events, particularly stroke. While     Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to     prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term     adherence to CPAP is a significant problem and search for alternative treatment is essential.   "
27889|NCT02920684|"     Despite several positive studies, benefits of early rehabilitation on recovery and motor     performance improvement need to be demonstrate. A recent study finds that despite early     rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises     applied in intensive care is common and most patients stay in bed.      Under these conditions, the optimal choice of the rehabilitation technique for bedridden     patient and its intensity should be studied.      The objective of the study is to evaluate the cardiovascular and metabolic response of     patients during four interventions: Passive legs mobilization, Passive cycloergometter,     Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.   "
28241|NCT02916030|"     Stroke remains one of the most devastating neurological diseases, often causing death, or     gross physical impairment. It is the second most common cause of death worldwide and a major     cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute     to the risk of cardiovascular disease especially stroke.   "
27890|NCT02920671|"     Investigators are recruiting adults (men and women, ages 18 to 65 years, inclusive) with a     confirmed genetic diagnosis of mitochondrial disease. Investigators are also recruiting both     obese and normal-weight healthy volunteers (men and women, ages 18 to 65 years, inclusive)     without a family history of mitochondrial disease to compare to affected individuals.      The study involves non-invasive MRI methods and glucose tests to focus on the relationship     between mitochondrial disease, obesity, and the risk of diabetes. All study visit procedures     will be completed within 2 days, which includes an overnight stay at the Hospital of the     University of Pennsylvania. There are no study medications or sedations, and participants     will be continually monitored during minimally-invasive procedures (e.g., blood draws).      All participants will be able to receive compensation. Furthermore, it may be possible to     provide reimbursement for travel, lodging, and meals for individuals with mitochondrial     disease.      Investigators hope that this research will contribute to the current knowledge of     mitochondrial disease and that it will improve diagnostic and treatment approaches.   "
27891|NCT02920658|"     This study evaluates the effectiveness of topical NAVS naphthalan in the treatment of oral     lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Half of participants with OLP     and RAS will receive topical NAVS naphthalan in adhesive paste, while the other half will     receive 0.05%-betamethasone dipropionate in adhesive paste. Our hypothesis is that NAVS could     be efficient in the treatment of OLP and RAS, with effects comparable to that of topical     steroids.   "
27892|NCT02920645|"     The primary objective of this multicenter study is to validate the AVICH score in terms of     patient outcome prediction in AVM patients with associated ICH.      Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is     measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2)     and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters,     which are part of the AVICH score, will be compared between the 2 groups: ICH score including     age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular     hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size,     eloquent location, and venous drainage, as well as the Lawton-Young grade, including age,     presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment     modalities, including embolization, radiotherapy, surgery or no treatment will be analysed.     Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.      Multicentre validation study      Key inclusion criteria:        -  All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before          hemorrhage        -  Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion          criteria.      Key exclusion criteria:        -  incomplete data set        -  AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH   "
27893|NCT02920632|"     This study evaluates the efficacy of an eight-week online cognitive training program on     objective and subjective cognitive functions in Parkinson's disease. Moreover, we intend to     map the effect on brain network function, and if cognitive training can prevent the     development of PD-MCI/PD-D after one-year follow-up. In this study, two training groups will     be compared (N: 60 vs 60). In half of the participants MRI and magnetoencephalography (MEG)     will be assessed (N: 30 vs. 30). We expect cognitive training to improve cognitive functions,     and to improve the efficiency of brain network function. Moreover, we expect that cognitive     training can decrease the risk of PD-MCI/PD-D at one-year follow-up.   "
27894|NCT02920619|"     The purpose of this study is to develop computational methods for cross-comparison of muscle     composition measurements in three laboratory ultrasound systems.   "
27895|NCT02920606|"     The procedure currently recommended for the treatment of irreversible pulpitis is the     endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation     of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at     an ulterior appointment by the root canal treatment. The purpose of the present pilot study     is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature     molars. If hemostasis can be achieved after removing the coronal part of the pulp, a     tricalcium silicate cement will be directly applied on the remaining pulp at the root canal     entrances. A short-term follow-up will be performed at one week by evaluating the pain relief     of the patient. Long-term success will then be evaluated every year by verifying the absence     of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and     signs. A standard root canal procedure will serve as control.   "
27896|NCT02920593|"     The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the     incidence of hypertensive disorders of pregnancy.   "
27897|NCT02920580|"     This randomized controlled trial will enrol patients with acute severe brain injury who pass     a spontaneous breathing trial but have decreased level of consciousness. It will directly     compare (1) prompt extubation vs. (2) prompt tracheostomy vs. (3) usual care, with extubation     or tracheostomy timed according to physicians' discretion. The primary outcome will be ICU     free days (days spent alive and outside an ICU).   "
27898|NCT02920567|"     This study aims to examine whether octreotide has an effect on inhibition of the exocrine     secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula     after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for     periampullary tumors were enrolled. The patients were randomly assigned to intervention (use     of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7     days. Every patients will undergo pancreaticojejunostomy with external stent for remnant     pancreas management. The pancreatic juice is drained through the external stent by negative     pressure and amounted.      Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary     endpoint was the rate of pancreatic fistula.   "
27899|NCT02920554|"     The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to     4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates     between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder     cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3     gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are     randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each     group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.   "
27901|NCT02920528|"     This is a prospective, randomized controlled trial which will be conducted to determine     whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with     chronic pain syndrome presenting to the emergency department with exacerbation of their     chronic pain. The investigators also aim to determine whether use of SDDK can reduce the     amount of subsequent opioid pain medications required for adequate pain relief in this     population.   "
27902|NCT02920515|"     This is a prospective, multicentric, comparative, non-randomized interventional study in     which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were     treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.   "
27903|NCT02920502|"     Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D     (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency     over the last few years is to give higher, less frequent doses. Disease-specific dosing is of     interest, and there may be optimal serum concentration targets based on disease process. The     best evidence so far is for optimal bone health, where most experts agree that 25OHD serum     concentration should be above 30 ng/ml.      There is mounting evidence that Vitamin D therapy will reduce inflammatory response and     macrophage activation. The optimal dosing needed to decrease the inflammatory response is     unclear, although our recent mouse model has demonstrated that a onetime high dose is     effective. The investigators therefore hypothesize that a one-time high dose of     cholecalciferol will be effective in suppression of macrophage production of tumor necrosis     factor-alpha (TNFa) and inducible nitric oxide synthase (iNOS). The purpose of this pilot     study is to assess the optimum dosage for the most macrophage suppression.   "
27904|NCT02920489|"     Neuraxial analgesia is the gold standard to relieve labor pain. A recent Practice guidelines     for obstetric anesthesia suggests that neuraxial analgesia should be provided in the early     stage of labor (cervical dilation < 5 cm) or on a individualized basis. The purpose of this     randomized controlled trial is to investigate whether neuraxial labor analgesia administered     on an individualized basis can improve analgesia quality and maternal satisfaction.   "
27905|NCT02920476|"     This is a non-randomized, open label, sequentially enrolling phase II study with a Simon     two-step enrollment design to evaluate the activity of TAS-102 in previously treated     unresectable or metastatic squamous non-small cell cancer after progression through or     intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered     orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine     the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of     unresectable or metastatic recurrent squamous non-small cell lung cancers.   "
27906|NCT02920463|"     DetermInants of Antimicrobial use aNd de-escalAtion in critical care (DIANA study), is a     multicenter, international, prospective, observational cohort study, aiming to describe the     rate of de-escalation as well as the associated outcome and the empirical antibiotic therapy     for infections at the intensive care unit.   "
27907|NCT02920450|"     The purpose of this research study is to determine if the study drug, Gedatolisib     (PF-05212384), given in combination with paclitaxel and carboplatin will work against     unresectable non-small cell lung cancer.   "
27908|NCT02920437|"     A pilot randomized controlled trial will be conducted to investigate the feasibility and     effectiveness of a salt intake reduction intervention to young hypertension patients in Hong     Kong who had high salt intake.   "
27909|NCT02920424|"     The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following     multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus     Erythematosus (SLE) and to determine whether premedication with corticosteroids is required     to improve the tolerability of SC JNJ-56022473.   "
27910|NCT02920411|"     The purpose of this study is to determine the effectiveness of a combined dermatological     treatment in children up to 5 years old with mild or moderated atopic dermatitis.   "
27911|NCT02920398|"     Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the     pivotal process and turoctocog alfa pegol from the commercial process in patients with severe     haemophilia A   "
27912|NCT02920385|"     This trial is conducted in Europe. The aim of this trial is to investigate the influence of     oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of     levothyroxine and the influence of co-administered tablets on the pharmacokinetics of     semaglutide administered orally in healthy subjects.   "
27913|NCT02920372|"     The study consists of generation of biological samples (in blood and urine) positive to     Epoetin alfa for laboratories that wish to perform the analysis of doping controls and     maintain accreditation from World Anti-Doping Agency.   "
27914|NCT02920359|"     The study consists of the generation of biological samples (in urine) positive to leuprorelin     acetate for doping control by new developed methods, and establish the analytical parameters     that reveal the administration of Leuprorelin acetate in healthy volunteers with these     methods.   "
27915|NCT02920346|"     The purpose of the research study Heart Sounds at Home is for pregnant SSA or SSA/SSB     (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to     detect abnormal heart rates and rhythms in their babies before they are born.   "
27939|NCT02920034|"     Prospective, randomized trial to assess the effectiveness of different renal sympathetic     denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a     cohort of patients with therapy refractory arterial hypertension and large renal arteries   "
27941|NCT02920008|"     Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment     choice (TC). Subjects will be randomly assigned in a 1:1 ratio to either guadecitabine or TC.     TC options include the 8 high or low intensity, locally available regimens below; or Best     supportive Care (BSC) alone:        -  High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide,          and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor          [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).        -  Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).        -  BSC.   "
27942|NCT02919995|"     This study evaluates two doses of RPL554 and placebo in adult patients with cystic fibrosis.     All patients receive all three treatments in a randomised sequence.   "
27916|NCT02920333|"     This study is to compare the efficacy of two types of non-invasive brain stimulation (NIBS)     in lower limb motor function recovery in stroke patients. The intervention will be tDCS     (transcraniel direct current stimulation) or rTMS (repetitive transcraniel magnetic     stimulation) plus conventional gait training for 10 days over 2 weeks.      The study hypothesizes that:        1. When combined with conventional gait training, NIBS could improve the walking ability of          stroke survivors.        2. NIBS will modulate cortex activity of the brain area representing the lower limbs.        3. The effects of NIBS might be related to some genetic factors. 45 subjects will be          randomly divided into 3 groups, receiving tDCS plus conventional gait training, or rTMS          plus conventional gait training, or sham tDCS plus conventional gait training.      The outcome measures include clinical functional assessment, brain activity assessed by TMS     measurement and MRI, genetic factor measurement. All these will be done at pre, immediate     after intervention and 4 weeks after intervention.   "
27917|NCT02920320|"     In this study, people who suffer from strong self-critical tendencies will be randomized to     two study conditions. The first group receives an account to an internet-based self-help     intervention. The second group is a waiting control group. In both conditions additional care     or treatment is allowed. The aim of the study is to investigate the effectiveness of an     internet-based self-help intervention on depressive, anxiety and stress symptoms compared to     a waiting list. Assessments are at baseline, 8-week and 6-months post-randomization. After 8     weeks, participants in the waiting control group get also access to the intervention and fill     out questionnaires after 8 weeks again.   "
27918|NCT02920307|"     Although mesh fixation has been associated to an increased incidence of nerve injury and     involves increased operative costs, many surgeons feel that fixation is necessary to reduce     the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of     laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.   "
27919|NCT02920294|"     To determine the small intestinal microbiota response in humans to dietary interventions for     two consecutive weeks, and to relate this to parameters of intestinal barrier function and     immune and metabolic responses in blood, as functional outcome parameters of host physiology   "
27920|NCT02920281|"     The aim of the study is to evaluate the impact of sleep quality on the length of mechanical     ventilation weaning, in intensive care unit patients   "
27921|NCT02920268|"     Recurrent abdominal pain affects up to 37% of school-age children, mostly girls. These     problems results in decreased quality-of-life, absence from school, lower sleep quality and     increased health-care consumption. Long-term effects are lasting pain-symptoms and increased     risk for psychiatric illness.      The scientific evidence for interventions towards long-term pain in children is limited and     pharmacological treatment is not effective. Cognitive behavioral therapy has shown some     effect but is time- and resource consuming. Dance and yoga can enhance positive protective     factors through better body awareness and increased self-regulation. Relaxation in yoga also     has positive effect on abdominal pain.      The aim of this study is to evaluate the effects of an intervention with dance and yoga for     girls, 9 to 12 years old, with recurrent abdominal pain. The participants will be identified     through pediatric clinics in Örebro County, primary health care and school health care. They     will be randomized to intervention with weekly dance- and yoga class for 8 months or control     group with standard treatment. Primary outcome is the fraction of girls in each group who,     direct after intervention, has decreased their maximum pain measured by Faces Pain Scale.     Secondary outcomes are stress, psychical health, well-being, school and sleep functions,     physical activity and health-economy. The study group will be followed up for two years.      Just-in-TIME is an interdisciplinary research group with expertise in interventions for     psychosomatic problems in children and adolescents. TIME, which stands for Try, Identify,     Move and Enjoy, also characterizes this project, aiming at decreasing recurrent abdominal     pain through an intervention with dance and yoga for 9-12 year old girls.   "
27922|NCT02920255|"     The objective is to compare the accuracy and reproducibility of measurements taken with     electronic calipers and conventional calipers. Using both calipers, reproducibility will be     determined by comparing results from a number of practitioners and accuracy will be     determined by comparing results with those obtained from X-rays.   "
27923|NCT02920242|"     This study will compare safety and efficacy of a generic rifaximin tablet to the reference     listed drug in the treatment of travelers' diarrhea. Additionally both the generic and     reference formulations will be tested for superiority against a placebo tablet.   "
27924|NCT02920229|"     Single-center, prospective, diagnostic trial in radically treated patients with biochemical     recurrence of prostate cancer. Patients with radically treated prostate cancer with     biochemical relapse and negativity of all traditional morphological and functional imaging     (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of     2-deoxy-2-[fluorine-18] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68     (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed     Tomography (CT) scan.   "
27925|NCT02920216|"     Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when     organ has to be preserved or when surgery is not indicated. The loco-regional failure is     about 30%. Then salvage surgery is the only chance for patients to survive but the overall     survival rate is only 29% at 24 months. This prognostic is bad because of poor local control     which is non-optimized by a complementary radiotherapy and negative exeresis margins.      Currently, there is no intraoperative technique to better visualize the tumor limits in real     time. With fluorescence techniques, an accurate mapping of tumor extension can be considered.     Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck     surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found     a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage     surgery for patient with head and neck cancer.      The ability of ICG to detect a surgical margin positive intraoperatively has never be     evaluated in irradiated area.      The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery     for recurrence of head and neck cancer in irradiated area.   "
27926|NCT02920203|"     The purpose of the study is to better identify hereditary cardiac causes of sudden unexpected     death in young subjects through Next-Generation Sequencing of autopsy tissue   "
27940|NCT02920021|"     The purpose of this study is to determine ANB020 safety, tolerability and activity in adult     patients with peanut allergy.   "
27927|NCT02920190|"     Background      Antigen-driven selection has been implicated in the pathogenesis of monoclonal gammopathies.     Patients with Gaucher's disease have an increased risk of monoclonal gammopathies and     symptomatic myeloma. Clonal immunoglobulin in patients with Gaucher's disease and in mouse     models of Gaucher's disease-associated gammopathy are reactive against lyso-glucosylceramide     (LGL1), which is markedly elevated in these patients and mice. A recent report indicates that     clonal immunoglobulins in 33% of sporadic human monoclonal gammopathies may also be specific     for the lysolipids LGL1 and lysophosphatidylcholine. Substrate reduction ameliorates     Gaucher's disease-associated gammopathy in mice. This principle (that antigen removal can     induce tumor regression) has been proven in other hematologic malignancies, where H. Pylori     eradication causes lymphoma regression is a significant group of patients. Thus, as longterm     immune activation by lysolipids may underlie both Gaucher's disease-associated gammopathies     and some sporadic monoclonal gammopathies, this may represent a focus for treatment.      Epicardial fat (EAT), the visceral fat of the heart, is highly enriched in genes involved in     inflammation and lipid metabolism; it activates local and systemic inflammation and innate     inflammatory response. EAT is rich in saturated fatty acids and has high protein content, and     the greatest capacity for free fatty acids release and uptake among any other visceral fat     depots. Of interest, EAT is highly enriched in sphingolipids, including ceramide. EAT     clinical measurability with an ultrasound technique, first developed and validated by     Iacobellis, and its rapid responsiveness and reduction to medications targeting the visceral     fat, such as the glucagon-like peptide 1 analogues (GLP1A), as ongoing clinical trials are     demonstrating, is of growing and remarkable interest.      Study Hypothesis      To target EAT, as marker of visceral fat, with GLP1A treatment to modulate/reduce/remove the     antigen(s) (lipid/inflammatory/immune) stimulation for patients with monoclonal gammopathies     that are lipid targeted.      Study Design      Interventional, single-group, open label pilot study. The investigators will identify     monoclonal gammopathy patients whose antibodies are lipid/visceral fat targeted (goal is 10     initially as a pilot) and who are overweight/obese (BMI > 27). Eligible patients will be     started on Liraglutide up to 1.8 mg sc once daily, as adjunct weight loss treatment for 12     months.      Study Endpoints        -  Ultrasound measured EAT reduction by at least 20%        -  Improvement in the monoclonal immunoglobulin profile Reduction in plasma ceramide and          lipidomics levels      Parameters will be monitored at 3 months, 6 months and 12 months.   "
27929|NCT02920164|"     Title of the study: Auricular acupuncture (AA) for pre-exam anxiety: A blinded randomized     crossover study on healthy volunteers      Study period: 04/2012 - 07/2012      Institution: Department of Anesthesiology and Intensive Care Medicine University Medicine of     Greifswald      Aim of the study: To investigate the anxiolytic effect of auricular acupuncture (AA) in     comparison to placebo acupuncture and no intervention during oral exams in anatomy at the     University of Greifswald      Design: Prospective blinded randomized crossover trial      Intervention:        1. AA using indwelling fixed needles, retained 24 h in situ        2. AA using placebo needles      Number of volunteers: N = 40      Outcome measures: Anxiety level, Heart rate, blood pressure.   "
27930|NCT02920151|"     This study evaluates the effect of balance circuit in patients with more than one year of     postoperative total hip or knee arthroplasty. Patients were randomized between intervention     group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The     evaluations were conducted by blind examiners.   "
27931|NCT02920138|"     Background: Study was designed to determine the effect of zero (ZEEP) and 5 mmHg positive end     expiratory pressure (5PEEP) on serebral oxymeter levels in morbid obese patients whose     undergoing laporoscopic sleewe gastrectomy. Second outcome is to investigate the effect of     IAP changes on cerebral oxygen values in LSG.      Method:18-65 yo, ASA2-3 status, 60 MO patients which planned SLG under general anesthesia     were included.Two patient in Group 5 PEEP were excluded because of the haemodynamic     instability during procedure. Patients were divided into 2 groups which was ventilated with     no PEEP (Group ZEEP)(n=30) and 5 cmH2O PEEP levels (Group5 PEEP)(n=28). All patients were use     right hand dominant. Near infrared spectroscopy probes were applied to both frontal cerebral     area of all patiens and measured rSO2 values. IAP were measured transvesically in all groups.     Datas were recorded as basal, after induction of anesthesia, 5 minute before     insuflation(5BI), 5 minute after insuflation(5BA), 15, 30, 45, 60 minute after induction, 5     minute before desuflation(5BD) and 5 minute after desuflation(5AD) time periods. Invasive     arterial pressures, serebral oxymeter values, 5 lead electrocardiography, peripheral oxygen     saturation, end tidal carbondioxide, peak inspiratory pressures, IAP, were recorded time     periods in all groups. Arterial blood sample analysed on 5BI,5AI, 5AD periods.   "
27932|NCT02920125|"     To evaluate the benefits of Ayurvedic SUVED & REIMMUGEN Colostrum for reduction/reversal of     symptoms and study clinical progress in Vascular disease; CAD, CAV, Stroke, DVT patients.   "
27933|NCT02920112|"     This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility     of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to the     usual standard of care in bariatric surgery patients. Participants one year post-surgery will     receive six sessions of Tele-CBT and complete measures before, during, immediately after, and     one year after participation in the study.   "
27934|NCT02920099|"     The purpose of this study is to develop a tool to help researchers better understand what     diet information people know and what skills they use to make diet choices.   "
27935|NCT02920086|"     The purpose of this study is to improve the outcomes of critically ill older patients and the     health outcomes of their families by capacitating and partnering with families in optimizing     patient/family centered care.   "
27936|NCT02920073|"     The objective of this trial is to evaluate gut microbiota changes in undernourished patients     with anorexia nervosa under enteral nutrition.   "
27937|NCT02920060|"     This study is a randomized, open label, parallel group,comparing the safety and efficacy of     valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus     not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU.     The primary outcome measures will be Proportion of children in either group who have     Cessation of all clinical seizure within 30 min of drug administration and secondary outcome     will be time taken to control seizure (minutes) from the initiation of infusion. Proportion     of children in either group who required additional drugs to abort ongoing clinical seizures,     rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in     hospital mortality) in the two groups were measured. Refractory status epilepticus condition     is major pediatric neurological emergency with high mortality and morbidity. Till now, the     treatment guidelines for it are based primarily on retrospective studies with very few     randomized studies. There is lack of sufficient data to recommend one drug over another for     treatment of refractory status epilepticus.   "
27938|NCT02920047|"     The purpose of this study is to evaluate the pharmacokinetics and safety when administrated     Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.   "
27957|NCT02919800|"     A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study     to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous     administration of a long-acting recombinant factor VIIa (MOD-5014) in healthy adult males.   "
27943|NCT02919982|"     The purpose of this study is to establish a benchmark for rate of prescription of oral     anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an     ambulatory care setting, based on independent medical assessment of clinical data and     physician and patient surveys. The study will also assess reasons for not prescribing OA to     prevent thromboembolic complications in patients with NVAF seen in ambulatory care, and     patients' perspectives of non-use of OA for treatment of NVAF.   "
27944|NCT02919969|"     This research study is studying a targeted therapy as a possible treatment for advanced anal     cancer.      The following intervention will be involved in this study:      -Pembrolizumab   "
27945|NCT02919956|"     Single ventricle lesions are the leading cause of illness and death from congenital heart     disease. The modified Fontan Operation is the corrective surgery for these lesions. The     operation is done in stages over a few years and children who complete the operation are     known to have greater neurodevelopmental (ND) deficits than the general population. The     purpose of this study is to understand how blood flow to the brain (CBF) and brain lesions     relate to ND outcome, as well as how CMRO2 relates to anatomic brain lesions. These     relationships will be studied through Magnetic Resonance Imaging (MRI) and ND Testing.   "
27946|NCT02919943|"     To define and evaluate the impact of angiographic coregistered OCT on physicians     decision-making through prospective data collection in PCI procedures.   "
27947|NCT02919930|"     The purpose of this study is to compare the effects of nasal and oronasal interfaces during     ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting     treatment with ASV, will be randomized between two groups. In the first group, patients will     use a nasal interface during the first night and an oronasal interface during the second     night. In the second group, patients will use an oronasal mask first and a nasal mask during     the second night. The results of this trial will have major impact on future clinical     practice as it would deliver prediction rules to choose the correct interface immediately.   "
27948|NCT02919917|"     While treatment strategies for OH have been identified for use in persons with acute SCI, the     field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome     parameters. Comprehensively documenting the impact of orthostatic hypotension (OH),     regardless of symptoms, during acute rehabilitation and identifying the effects of two     different treatment approaches on therapy participation and adherence to an intended     rehabilitation plan could have a significant impact on clinical practice in the acute     rehabilitation setting following SCI.   "
27949|NCT02919904|"     The feasibility of using the Apnea Risk Evaluating System (ARESTM) device to take     longitudinal measures of sleep parameters in asymptomatic men with prostate cancer who are     about to initiate androgen deprivation therapy (ADT) will be evaluated. Study participants     will complete serial questionnaires relating to sleep quality, hot flashes, and quality of     life.   "
27950|NCT02919891|"     This is a retrospective, observational study which will utilise the Edinburgh Cancer Research     Centre's Tissue Bank to provide samples for IENFD testing in those who have undergone     mastectomy surgery for breast cancer.      The investigators shall identify all those patients in the Tissue Bank database who have     undergone mastectomy surgery for breast cancer. The investigators shall consult the patient's     electronic health record, and general practitioner if required, to ascertain whether the     patient has died, been diagnosed with cognitive impairment or a psychotic disorder, or     receiving ongoing oncological treatment which would exclude them from the study. The     investigators shall also exclude all those patients who received surgery within the last year     as we intend to elucidate the presence of pain in the immediate post-operartive period up to     12 months post-operatively.      Having identified these patients the investigators shall contact them via post with a pack     containing an information document, a consent form and questionnaires. As this is an     observational study we shall contact all of the identified patients who meet the inclusion     criteria with the aim of recruiting as many as possible. The investigators would anticipate a     high response rate as has been the experience with previous questionnaire studies of breast     cancer patients.      Once a signed consent form has been returned the patient's tissue sample would undergo IENFD     testing. Their questionnaire responses will allow participants to be split into two groups     based upon whether they experience CPSP or not. Blinding of this grouping will take place so     that those undertaking the IENFD testing are unaware of the patient's questionnaire     responses.      Statistical analysis of the two group's IEFD results and questionnaire responses will then be     undertaken with the null hypothesis that the pre-operative IENFD at the site of surgery does     not predict or correlate with CPSP.   "
27951|NCT02919878|"     Phase II Study of Neo-adjuvant Chemoradiotherapy using infusional Gemcitabine followed by     Surgery for Locally Advanced (T3 and T4 or Node positive) Rectal Adenocarcinoma.   "
27952|NCT02919865|"     Radiation therapy is an important adjunct in the treatment of patients with glioma, although     a common side effect is radiation-induced injury of brain parenchyma. Unfortunately,     conventional MRI is not accurate in differentiating radiation-induced brain injury from     recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent     studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI     can be performed with an injection of exogenous contrast using dynamic contrast enhancement     (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be     performed without contrast injection using arterial spin labeling (ASL) or intravoxel     incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to     convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted     contrast enhancement (DSC) perfusion is the most common technique used in clinical practice     but measurement of tumor relative cerebral blood volume (rCBV) can be biased by extravascular     contrast leakage and susceptibility-weighted artifacts. The purpose of this study is to     evaluate the accuracy of perfusion MR imaging using non-contrast and contrast-based     techniques in differentiating recurrent tumour from radiation-induced brain injury in     patients with known high grade glioma. The investigators will compare the accuracy of IVIM,     ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new different T1     mapping methods used for DCE-MRI.   "
27953|NCT02919852|"     The purpose of this study is to identify whether a new operative technic would be acceptable     in female with pelvic organ prolapse.   "
27956|NCT02919813|"     The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior     Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a     counseling technique that has been shown to reduce pain and anxiety with other medical     conditions, including chronic pain conditions. The investigators wish to see if participation     in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV greater than     education alone. Both techniques use a group setting including other women with PLV.     Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized Vulvodynia is a     study designed to learn more about the use of mindfulness based group cognitive behavior     therapy for PLV pain and anxiety over education alone. Participants will be randomized to one     of two groups: mindfulness based cognitive behavior therapy or group education seminars.   "
27960|NCT02919761|"     2 part multicenter study to examine the effect of Acthar in adult subjects with rheumatoid     arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in which all     eligible subjects receive Acthar for 12 weeks. After 12 weeks of treatment with Acthar,     subjects will be evaluated for treatment response using the DAS28-ESR. Subjects who have     achieved low disease activity will enter a double-blind randomized maintenance period (Part     2) and be randomized in a 1:1 ratio to receive either Acthar or matching placebo for an     additional 12 weeks.   "
27961|NCT02919748|"     To evaluate the efficacy of choral singing in the prevention of dementia and examine the     underlying mechanisms using Magnetic Resonance Imaging (MRI) technique and a panel of     peripheral biomarkers in venous blood and urine. The investigators hypothesize that Choral     singing could prevent cognitive decline among community-dwelling elderly who are at high risk     of dementia. The underlying neural mechanisms involve the changes in brain structure and     function that can be quantified using MRI technique. The changes in cognitive outcomes will     be accompanied by observable changes from a panel of carefully selected peripheral     biomarkers.   "
27963|NCT02919722|"     Investigators hypothesize, based on anecdotal evidence to date, that active music making     interventions conducted on a patient's neglected side will result in improved attention to     that side and that this will be measurable within session.   "
27964|NCT02919709|"     The study aims to investigate the existence of a reliable correlation between the progression     of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in     patients with not surgical aortic aneurysms.   "
27965|NCT02919696|"     The purpose of this study is to determine the safety of the study drug known as abemaciclib     in native Chinese participants with advanced and/or metastatic cancers.   "
27966|NCT02919683|"     This research study is studying nivolumab, an investigational drug, in combination with     ipilimumab, also an investigational drug, as a possible treatment for Squamous Cell Carcinoma     of the oral cavity.      The following drugs are involved in this study:        -  Nivolumab (Opdivo™)        -  Ipilimumab (Yervoy™)   "
27967|NCT02919670|"     This research study is evaluating Enterade, a supplement, as a possible treatment for the     side effects caused by Stem Cell Transplant.      The following interventions will be involved in this study:        -  Enterade plus standard supportive care        -  Placebo plus standard supportive care. The placebo will be a mixture of water,          electrolytes, and sweetener.   "
27968|NCT02919657|"     Genepro Gen2 Absorption and Protein Value Clinical Trial.   "
27969|NCT02919644|"     Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant     vaccination with autologous dendritic cells loaded with autologous tumour homogenate after     curative resection for stage IV colorectal cancer   "
27970|NCT02919631|"     Background: Patients with the sugar metabolism disorder, Glycogen Storage Disease Type V,     have insufficient breakdown of sugar stored as, glycogen, within the cells. The investigators     know from previous studies with McArdle patients, that they not only have a reduced sugar     metabolism, both also have problems in increasing their fat metabolism during exercise to     fully compensate for the energy deficiency.      Studies on Triheptanoin diet used in patients with other metabolic diseases have shown that     Triheptanoin can increase metabolism of both fat and sugar. In these patients, Triheptanoin     has had a positive effect on the physical performance and has reduces the level of symptoms     experienced by patients.      Aim: To investigate the effect of treatment with the dietary oil, Triheptanoin, in patients     with McArdle disease on exercise capacity.      Methods: 20-30 adult patients will be recruited through Rigshospitalet in Copenhagen, Denmark     and Hopital Pitié-Sapêtrière in Paris, France.        1. Pre-experimental testing (1 day): Baseline blood samples are collected to obtain          baseline values of safety parameters: Plasma-acylcarnitines, free fatty acids and          creatine kinase. Subjects perform a max-test to determine their VO2max        2. Treatment period #1 (2 weeks): Subjects follow a diet consuming a dietary treatment oil.          Neither patients nor members of the study group know who receive which type of oil.        3. Washout period (1 week +7 days): Subjects receive no treatment        4. Treatment period #2 (2 weeks +7days): Subjects who received Triheptanoin oil in the          first treatment period, now receive placebo oil and vice versa.      Assessments: Before and after each treatment periods, subjects perform a 30-minutes exercise     test on a cycle ergometer, comprising of 20-22 minutes of constant load exercise and 6-8     minutes increasing load to peak. Subjects will complete a Fatigue Severity Scale     questionnaire and metabolic products will be measured in blood and urine.   "
27971|NCT02919618|"     Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of     Ventricular Tachycardia   "
27972|NCT02919605|"     Introduction: Up to the present, have been few studies with pentamidine in the Americas; and     there is no consensus regarding the dose used.      Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the     treatment of cutaneous leishmaniasis.      Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used     at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be     also assessed the safety and adverse effects. The sic will be reviewed one, two and six     months after the end of the treatments.   "
27974|NCT02919579|"     The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg)     dose of intranasal esketamine compared to placebo, on next day driving performance and     repeated administration of 84 mg intranasal esketamine on same-day driving performance as     assessed by the mean difference of standard deviation of lateral position (SDLP) from an     on-road driving test.   "
27975|NCT02919553|"     The purpose of the study is to compare two particular techniques of tissue (capillary vs     wet-suction techniques) sampling during endoscopic ultrasound guided fine needle     aspiration/biopsy (EUS-FNA/FNB) of a solid lesion to determine the diagnostic yield and     procedure logistics (e.g. procedure time).   "
27976|NCT02919540|"     This project aims at testing the effect of applying the KMC on the premature infants'     physiological outcomes. The findings of this project are expected to contribute to the     discipline of preterm infants' care by providing evidence of the benefits, barriers, and     facilities of providing the KMC in our Jordanian NICUs.   "
28006|NCT02919306|"     The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26     (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on     suppressive antiretroviral therapy (ART) that was initiated during acute Human     Immunodeficiency Virus (HIV) infection; 2) Measure the frequency and duration of sustained     viremic control after receiving Ad26 prime/MVA boost or placebo, defined as greater than 24     weeks with plasma HIV ribonucleic acid (RNA) lesser than (<)50 copies/ml after antiretroviral     (ARV) analytical treatment interruption (ATI).   "
28242|NCT02916017|"     This study evaluates the long- term safety and effectiveness of adalimumab in participants     with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.   "
27977|NCT02919527|"     Treatment or training of fascial tissues has moved into the focus of medical research in the     last decade. In this context, the use of foam rollers or roller massagers for     self-myofascial-release (SMR) techniques has become increasingly popular in health and     fitness professionals. The primary objective of these techniques is to mimic manual massage     or myofascial-release therapy with a self-usable tool. Recent studies suggest that SMR     improves, inter alia, range of motion (ROM) without a decrease in neuromuscular performance     (Cheatham et al. 2015).      Concurrent effects on the muscle and especially the surrounding connective tissue network     have been proposed as underlying mechanisms for these observed changes in ROM after SMR.     Several authors assume a positive effect of SMR on sliding properties of different     independent fascial layers. Also, changes in passive tissue stiffness is suggested. Passive     stiffness is thereby characterized by passive resistance in the tissues' (muscles')     functional direction, the passive resistive torque (PRT).      In conclusion, for many of the proclaimed effects of SMR, such as improvements of sliding of     fascial layers or decreases of passive stiffness, there is a lack of evidence in the     literature. Therefore, the aim of the study is to evaluate acute effects of SMR on the     viscoelastic properties of the muscles on the anterior thigh and the corresponding fascia.      In a cross over design, 16 subjects receive all of the following interventions after a     familiarization session: a) 2x60 seconds of SMR at the anterior thigh, b) 2x60 seconds of     static stretching at the anterior thigh, c) no intervention in a balanced permutated     randomization sequence. Before and directly after each intervention, outcome parameters are     collected.      Passive Resistive Torque is evaluated using a computerized isokinetic dynamometer. In passive     mode, the lower leg is moved from full knee extension (0°) to the point of maximal knee     flexion with a velocity of 5°/s. Torque and angle are recorded at 100 Hertz (Hz). Sliding of     fascial layers is quantified with a frame-by-frame cross correlation algorithm of     high-resolution ultrasound images (Dilley et al. 2001).      First stretch sensation is quantified using the passive mode in the isokinetic dynamometer.      Maximal ROM is detected using a an ultrasonographic movement analysis system in a prone     position.   "
27978|NCT02919514|"     To investigate effects of soft, sand and hard surfaces on functional ability and falls in     elderly with or without history of multiple falls.   "
27979|NCT02919501|"     To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and     vortioxetine 10 mg/day oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on     depressive symptoms   "
27980|NCT02919488|"     The purpose of this study is to determine if postprandial (after a meal) endothelial (inner     lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of     exercise   "
27981|NCT02919475|"     This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of     JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are     receiving background non-biologic disease-modifying anti-rheumatic drug therapy.   "
27982|NCT02919462|"     This is an open-label, multicentre, randomized phase II trial.      Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS)     expression , will be randomly assigned with 1:1 ratio to the following treatment Arms:      A. 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral     Vinorelbine until disease progression      B. 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease     progression      Treatment will be repeated every 21 days .   "
27983|NCT02919449|"     This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of     attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and     metastatic NSCLC.   "
27984|NCT02919436|"     Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to     tamsulosin versus a placebo.   "
27985|NCT02919423|"     The purpose of this study is to investigate the modulatory effects of repetitive transcranial     magnetic stimulation (rTMS) on functional connectivity with the insula. Functional     connectivity (FC) measures the interaction between brain regions, and recent neuroimaging     studies have used FC to investigate how addiction affects FC among pertinent brain regions.     rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain     connectivity and could be used therapeutically to treat addiction. However, investigators     first need more information on brain FC and how it relates to behavior, in order to guide     rTMS target selection.   "
27986|NCT02918656|"     The objective of the investigators study is to evaluate the efficacy of infographics in     presenting information, in terms of understanding and remembering research results, compared     to standard PLS formats and scientific summary formats (SciSum).   "
27987|NCT02918643|"     Objective: To develop and evaluate the effectiveness of a mobile application to support     decision making for prescription drugs to elderly patients. Method: Firstly, there will be a     two-tier content validation of potentially inappropriate medicines (PIM) for the elderly     based on Beers Criteria and STOPP. For the validation, a modified Delphi consensus technique     will be applied. Twelve national experts will be invited. For each statement contained in the     Beers criteria and STOPP a proposition will be prepared in order to allow each participant to     issue an opinion on each of the propositions by assigning a value according to their     agreement to the statement. Therefore, the Likert scale with established score of 1 to 5     (completely disagree - strongly agree) will be used. Statements with average scores above 4.0     will be considered consensus. All information regarding PIMs will be made available through     an application for tablets. The information on risks and recommendations about the drugs will     be available whenever the users enter the medicines name. The application will be developed     for the Android platform, which is based on the Java programming language. To evaluate the     use of this application 30 doctors working in basic health units and health units of the     family in a municipality from Bahia will be asked to join the study. Upon acceptance, the     proportion of PIMs' prescription by these professionals for a minimum period of two months     will be analyzed. Later, 15 doctors will be randomized into the intervention group and will     receive a tablet with the application installed. They will be trained to use it as well as to     access to the Evidence Based Health Portal of the Ministry of Health. The control group of 15     other physicians will receive the tablet and will be trained to access the Evidence Based     Health Portal. The study will be blind to the participants and to the main investigator. To     continue, the information will be analyzed by sampling the PIMs' prescription in both groups.     To access this information the prescriptions' duplicate original, filed in pharmacies,     patient files or home visit will be required. The PIMs prescription ratios before and after     the intervention will be compared.   "
27988|NCT02918630|"     The purpose of this study is to assess if access to an electronic nicotine delivery device,     or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among     individuals diagnosed with schizophrenia compared to nicotine patch alone.   "
27989|NCT02918617|"     This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing     toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a     commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin®     technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium     monofluorophosphate (MFP).   "
27990|NCT02918604|"     multicenter, prospective and cohort study to evaluate infrared technology for identifying and     and indwelling peripheral veins in 0 up to 4 years old children.   "
28086|NCT02918097|"     To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD)     using medications available in the Brazilian Public Healthcare System (SUS). Quality of life     assessment of these patients was also employed.      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of     episodes of bipolar disorder depression episodes.   "
27991|NCT02918591|"     It has been shown that in patients with type 2 diabetes (T2D) at high risk for cardiovascular     disease (CVD) who received Empagliflozine as compared with placebo had a lower rate of death     from cardiovascular causes, non-fatal MI, or non-fatal strokes as well as death from any     cause and hospitalization for heart failure.      This lower incidence of cardiovascular disease in individuals treated with selective     inhibitor of renal sodium-glucose co-transporters (SGLTs) has been associated with reduction     of blood levels of fibroblast growth factor 23 (FGF23) and with increase of blood levels of     Klotho.      Therefore we will investigate the blood levels of fibroblast growth factor 23 (FGF23) and of     Klotho in type 2 diabetic patients treated with Empagliflozine The investigators anticipate     that patients treated with Empagliflozine will have decreased levels of FGF23 and increased     levels of Klotho which would provide a good explanation for the beneficial cardiovascular     effects of selective inhibitors of renal sodium-glucose co-transporters (SGLTs)   "
27992|NCT02918578|"     The purpose of this study is to compare different modalities to communicate a remote and     individually tailored physical activity promotion program.   "
27993|NCT02918565|"     A 5-arm randomized trial to determine what components of a text message intervention are     necessary to reduce hazardous drinking among young adults and mechanisms through which these     changes occur.   "
27994|NCT02918552|"     This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in     subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and     invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle bioenergetics,     serology including inflammatory markers and platelet bioenergetics, quality of life measures.   "
27995|NCT02918539|"     This registry will be used to identify patients who have etiology diagnosed or suspected to     be Alzheimer's disease and positive amyloid scans, and have indicated their interest in being     contacted for an Eli Lilly and Company (Lilly) Alzheimer's Disease drug research trial.   "
27996|NCT02918526|"     The purpose of the study will be to record the hemodynamic response measured by traditional     methods (non-invasive blood pressure and ECG) and Pressure Recording Analytical Method in     patients undergoing laryngeal mask placement compared with the hemodynamic response measured     in patients undergoing laryngoscopy and tracheal intubation for performing surgery in     gynecological area and assess the differences with the two methods.   "
27997|NCT02918513|"     The purpose of this study is to explore the efficacy and feasibility of an integrated,     prescriptive, and trackable wellness intervention combining five wellness elements including     exercise, mindfulness, sleep, social connectedness, and nutrition.   "
27998|NCT02919410|"     This is a prospective, randomized control trial evaluating the efficacy of     iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.   "
27999|NCT02919397|"     The overall aim of this feasibility trial is to assess the effectiveness of a wearable     technology and an e-diabetes prevention programme delivered via a smartphone application,     including motivational messaging, in reducing weight and increasing physical activity in     people at risk of developing type 2 diabetes.   "
28000|NCT02919384|"     During this study, patients will undergo a routine in vitro fertilization cycle as they would     otherwise if not participating in the study. After eggs have been fertilized they will be     cultured as usual until day 3 of embryo development. On day 3 of development, the     embryologist will randomize half of the embryos to be cultured in 2% oxygen concentration and     the other half at 5%, which is currently the standard of care. All other embryological care     procedures will remain the same. On day 5 or 6 of embryo development, the embryos will be     evaluated and each blastocyst stage embryo will be recorded. The primary outcome will be the     blastulation rate (or percentage of embryos that reach the blastocyst stage).   "
28001|NCT02919371|"     Combined sunitinib and bevacizumab in advanced renal cell carcinoma.   "
28002|NCT02919358|"     The purpose of this study is to investigate the effect of classical music exposure on     improved time to regain birth weight and improved feeding readiness in healthy premature     infants in the NICU.   "
28003|NCT02919345|"     Background Endothelial dysfunction is one of the early events in atherosclerotic plaque     development. It is characterized by an increased ratio of substances with vasoconstrictive,     pro-thrombotic, and proliferative properties over substances with vasolidatory,     antithrombogenic and antimitogenic properties. Endothelial dysfunction is also associated     with high-risk patients with coronary artery disease. Hyperglycemia, obesity, hypertension     and fat mass also impair the endothelium by increasing the expression of cytokines,     inflammatory markers and vascular markers.      Hypothesis Administration of dapagliflozin in addition to metformin background with clinical     or subclinical cardiovascular atherosclerotic disease improves endothelial function when     compared to those using glibenclamide in addition to metformin.      Objectives Evaluate the effect of dapagliflozin vs glibenclamide on a metformin background on     endothelial function in patients with clinical or subclinical cardiovascular atherosclerotic     disease and poorly controlled diabetes.      Enpoints Prymary Change in flow mediated dilation (FMD) and its related endpoint (FMD post     reperfusion lesion) between the randomization visit and over 12 weeks of treatment.      Secondary Change in plasma nitric oxide, isoprostane, ICAM-1, VCAM-1, ET-1, leptin,     adiponectin, C-reactive protein, TNF- α, interleukin-6, interleukin-2, weight and body     composition (% of fat mass and % free fat mass) at the randomization visit and over 12 weeks     of treatment.      3      Design Randomized, parallel-group, comparative, prospective clinical study. The study is     divided in two phases: Run-in and Randomization. In the former phase, which must have the     maximum period of 16 weeks, patients will visit the outpatient to adjust metformin and blood     pressure medications. After run-in phase, patients that fulfill inclusion criteria will     perform an ambulatory blood pressure monitoring (ABPM) in order to asses BP; body composition     will be assessed by dual x-ray absorptiometry (DXA); endothelial function as assessed by flow     mediated dilation and vascular cytokines. Patients will by randomized to dapagliflozin or     glibenclamide on a metformin background. After 12 weeks, the ABPM, DXA and endothelial     function will be assessed.   "
28004|NCT02919332|"     This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission     tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in     patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the     brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG     administration and PET/CT scan may improve the visualization of brain tumors in patients with     glioblastoma.   "
28005|NCT02919319|"     The main objectives of this first-into-man study were to investigate the safety, tolerability     and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults.     Pharmacodynamic effects (through a battery of Central Nervous System tests) were also     assessed.   "
28087|NCT02918084|"     Breast cancer is the most common form of cancer among women. For patients candidated for     adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly     defined yet.   "
28007|NCT02919293|"     To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A     and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.      Primary objective:        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups          A, C and Haemophilus influenzae type b following the administration of adjuvant-free          MenAC-Hib conjugate vaccine compared to those observed following the administration of          adjuvant MenAC-Hib conjugate vaccine.        -  To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to          that of adjuvant MenAC-Hib conjugate vaccine.      Secondary objective:      •To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae     type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those     observed following the administration of adjuvant MenAC-Hib conjugate vaccine.   "
28008|NCT02919280|"     The Dallas 2K is a 5-year natural history, longitudinal, prospective study of a cohort of     2,000 participants that will help uncover the socio-demographic, lifestyle, clinical,     psychological and neurobiological factors that contribute to anti-depressant treatment     response: remission, recurrence, relapse and individual outcomes in depressive disorders.     Hence, the expected duration of this study is 10 years in length. Since this is an     observational study, investigators will explore a comprehensive panel of carefully selected     participant specific parameters: socio-demographic (age, ethnicity, economic); lifestyle     (physical activity, substance use); clinical (medical history, anxious depression, early life     trauma), biological (biomarkers in blood, saliva, urine), behavioral (cognitive, emotional),     neurophysiological (EEG), and neuroimaging (structural, functional brain circuitry) with the     goal to develop the most robust predictive models of treatment response and of depression     outcomes. There is no medication or non-medication treatment or intervention provided by this     study.      Subjects will have elevated symptomatology of nonpsychotic chronic or recurrent depressive     disorder and will be currently receiving or will be prescribed standard of care medication or     non-medication based treatments by their providers/clinicians. The study cohort will reflect     the wide range of patients seen in typical primary or psychiatric care settings, and may     include unipolar or bipolar disorders and dysthymia (a more chronic form of depression). The     cohort will be broadly representative of and generalizable to the US general population as a     whole.      Participants will be recruited from the UT Southwestern Depression Cohort, a registry of     volunteers who have consented to learn more about participation in depression-related     research studies -(IRB STU: 092015-049). Participants external to the Depression Cohort will     first be consented and enrolled in the Depression Cohort before being consented and enrolled     in the Dallas 2K study.   "
28009|NCT02919267|"     Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic     anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double     lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during OLV     is not well described in the literature. Few publications characterized scant aspects of lung     collapse, only with the use of DLT and sometime in experimental animals. Two phases of lung     collapse have been described. The first phase is a quick and partial secondary to the     intrinsic recoil of the lung. The second phase is the reabsorption of gas contained in the     alveoli by the capillary bed. The investigators plan to describe the physiology of the second     phase of lung deflation using of DLT or BB, in a human clinical context.   "
28010|NCT02919254|"     The purpose of this study is to examine the effect of varying nitrate doses of beetroot juice     supplementation on dynamic, multijoint resistance exercise performance in active, trained     individuals. Performance will be assessed based on parameters including neuromuscular     efficiency, anaerobic performance capability, oxygen consumption, plasma nitrate/nitrite     levels, specific muscle tissue biomarkers including lactate, and anthropometric measurements     of select muscle groups.   "
28011|NCT02919241|"     Clinical trial of an application of cognitive behavioural one-session therapy method with     patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety     Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and     one-session treatment of dental care. The method is based on One-Session Therapy manual (Öst     & Skaret, 2013). 30 minimum 18 years old adults takes part to the study. They comes from     three different places,primary care clinic, community dental care and dentist´s teaching     clinic.   "
28012|NCT02919228|"     NOTE: This is the fourth of in total 7 sub-studies related to the Ethics Committee of the     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8     arms, in total 350 participants will be assessed in all 7 sub-studies.      General study information: This is a randomized, cross-over, quantitative study, which     investigates physiological variables, mood, and affect of healthy participants in response to     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored     light only, or are additionally asked to solve cognitive tasks during the colored light     exposure. Primary aim is to measure the change in several physiological variables, mood, and     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is     negligible and comparable to the risk during daily life.   "
28022|NCT02919098|"     The investigators have developed a game-based sexual violence prevention program that uses a     bystander intervention approach. This program is called Bystander and was designed for use     with high school students in grades 9-12. The goal of this research is to evaluate the     efficacy and feasibility of Bystander when implemented in a school setting. The research will     capture data on knowledge about sexual violence and harassment, as well as attitudes,     self-efficacy, perceived social norms and behavioral intentions around bystander behaviors.     This research will consist of a baseline survey, program participation, a immediate     post-program survey, and a 3-month follow up survey with youth participants. It will also     involve qualitative in-depth interviews with school staff and administration about the     program.   "
28209|NCT02916446|"     This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy     in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or     a placebo for a period of 6 months, after which all subjects will be receiving the active     treatment up to a period of 3 years under active treatment.   "
28023|NCT02919085|"     To analyze changes on respiratory muscle strength, peripheral and functional capacity of     critically ill patients with clinical and surgical etiology, breathing spontaneously and     bedridden, within 48 hours of admission to the intensive care unit (ICU) and if there are     correlations among these variables. This is an observational study. Respiratory muscle     strength will be assessed through the maximum inspiratory pressure (MIP) and maximal     expiratory pressure (MEP) and peripheral muscle strength, by the Medical Research Council     score (MRC) and hand grip test and functional capacity through the Functional Independence     Measure (FIM) and Physical Function ICU Test Score (PFIT-s) in the period between 24h and 48h     of hospitalization in the adult ICU. For descriptive purposes, the sample will be stratified     according to clinical and surgical characteristics. Correlations will be determined using the     Pearson test, with significance level of p <0.05.   "
28013|NCT02919215|"     Teachers are increasingly faced with classrooms of students whose needs require support far     beyond what traditional teacher-training programs prepare educators to provide. The presence     of students with greater challenges in classrooms is due in part to the move to a full     inclusion model of education and also to the rising epidemic of mental health disorders in     youth. Mental health problems affect up to one million Canadian youth and their families.     However, few of these individuals (~20%) receive the support they need (Kirby, 2013; Kutcher     & McLuckie, 2013). The Teacher Help research team along with industry partner, Velsoft, and     key knowledge user, Nova Scotia Department of Education and Early Childhood Development, will     address this barrier by developing, evaluating, and commercializing a sustainable eHealth     resource for teachers. Teacher Help is an online program that assists teachers in providing     evidence-based interventions to students in grades 1-12 with mental health disorders in the     classroom. The program allows teachers in a typical classroom setting to access information     and expert-coach and peer support when they need it, so they can intervene early in order to     reduce the negative consequences of mental health disorders in youth. Currently three modules     (Attention-Deficit/Hyperactivity Disorder [ADHD], Autism Spectrum Disorder [ASD], and     Learning Disabilities [LD]) are at different stages in the innovation pipeline. The     investigators will test whether teachers make good use of this program and whether it is     effective in improving mental health outcomes among children and youth both at school and at     home. The investigators will also study whether the program changes teacher's attitudes     toward children and youth with these disorders. The investigators will provide information to     the Department of Education on how to use this program. This approach will help ensure that     the program will continue after the research study ends. To the Teacher Help team's knowledge     Teacher Help is the first and only research-validated eHealth program directly targeting     teachers to help them intervene with children and youth who have mental health disorders,     thus allowing Canada to take a lead in eHealth as applied to a school context.   "
28014|NCT02919202|"     This study compares the efficacy of two dental interventions in the treatment of cervical     dentine sensitivity. The participants will be selected from adult dental patients registered     at a general dental practice in West Sussex, UK. The participants will be split into 2     groups. One group will receive the intervention of topical fluoride varnish application while     the other group will receive a topical application of self-etching dentine bonding agent.   "
28015|NCT02919189|"     NOTE: This is the fifth of in total 7 sub-studies related to the Ethics Committee of the     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8     arms, in total 350 participants will be assessed in all 7 sub-studies.      General study information: This is a randomized, cross-over, quantitative study, which     investigates physiological variables, mood, and affect of healthy participants in response to     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored     light only, or are additionally asked to solve cognitive tasks during the colored light     exposure. Primary aim is to measure the change in several physiological variables, mood, and     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is     negligible and comparable to the risk during daily life.   "
28016|NCT02919176|"     This is an open lable, pilot study in which the investigator will research the effect of two     FDA approved drugs, Mirabegron and Pioglitazone on fat tissue.      Pioglitazone is drug approved by the FDA for the treatment of diabetes and Mirabegron is a     drug that is approved by the FDA for the treatment of overactive bladder. These drugs are not     approved by the FDA for the purposes being studied in this research. Therefore, the way in     which the investigator intends to use them in this study are considered investigational.   "
28017|NCT02919163|"     NOTE: This is the sixth of in total 7 sub-studies related to the Ethics Committee of the     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8     arms, in total 350 participants will be assessed in all 7 sub-studies.      General study information: This is a randomized, cross-over, quantitative study, which     investigates physiological variables, mood, and affect of healthy participants in response to     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored     light only, or are additionally asked to solve cognitive tasks during the colored light     exposure. Primary aim is to measure the change in several physiological variables, mood, and     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is     negligible and comparable to the risk during daily life.   "
28018|NCT02919150|"     The aims of this study are:        -  To examine the inter-rater reliability to assess myofascial trigger points using a          myotonometer        -  To determinate the strength of the correlation between myotonometric parameters and          isokinetic parameters        -  To evaluate the sensitivity of myotonometric measurements to detect the location of          myofascial trigger points   "
28019|NCT02919137|"     NOTE: This is the seventh of in total 7 sub-studies related to the Ethics Committee of the     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8     arms, in total 350 participants will be assessed in all 7 sub-studies.      General study information: This is a randomized, cross-over, quantitative study, which     investigates physiological variables, mood, and affect of healthy participants in response to     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored     light only, or are additionally asked to solve cognitive tasks during the colored light     exposure. Primary aim is to measure the change in several physiological variables, mood, and     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is     negligible and comparable to the risk during daily life.   "
28020|NCT02919124|"     The aim of this study is to evaluate whether use of the echoclip device (an ultrasound     transducer positioning device which can stabilize the involved part of the myocardium on the     beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass     surgery. A total of 100 low risk patients undergoing elective on-pump coronary bypass surgery     will be included in the study in order to evaluate if the surgeons can visualize the coronary     anastomoses before closure of the sternum. Ultrasonograpic pictures will be analyzed directly     peroperatively and electronically post-operatively in order to evaluate if selected areas of     the anastomoses can be visualized. Use of the echoclip devise will be considered a success if     at least 80% of the anastomoses can be visualized.   "
28021|NCT02919111|"     The investigators are imaging patients with prostate cancer using a new PET imaging agent     (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients     with high risk disease prior to prostatectomy.   "
28036|NCT02918903|"     The objective of this study is to assess and compare the possible post-operative pulpal     symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of     pulp exposure, child acceptance, chair time and radiographic success between two techniques     for managing dental caries: minimal caries removal and complete caries removal in primary     molars.   "
29325|NCT02901808|"     The registry includes patients undergoing cardiovascular and thoracic surgery at the Saarland     University Medical Center, Homburg/Saar, Germany. This study is a monocentric, retrospective     study investigating the development of NOMI and outcome of patients.   "
28026|NCT02919046|"     This single-arm, multicenter clinical study will treat the patient who have relapsed or     refractory neuroblastoma with an infusion of the patient's own T cells that have been     genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour     cells modified to express the GD2 protein on the cell surface. The study will determine if     these modified T cells help the body's immune system eliminate tumour cells .The trial will     also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body     and the impact on this treatment for survival.   "
28027|NCT02919033|"     This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine     Model (PCTM) with usual care and self-care in community hypertension management in China.   "
28028|NCT02919020|"     To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF)     as physical therapy approach to the reduction of pain and improvement in functional     performance and quality of life in women with knee osteoarthritis.   "
28029|NCT02919007|"     This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.   "
28030|NCT02918994|"     The purpose of this investigation is to conduct a series of case studies on the impact of     LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for     participants with Traumatic Brain Injury (TBI).   "
28031|NCT02918981|"     Using stable isotope methodology, investigators will determine the postabsorptive and     postprandial muscle protein synthetic response in 60 female adults (Age 50-79, BMI: <30     kg/m2) immediately after an acute bout of resistance exercise. Participants will be divided     in to 5 groups of twelve women (n=12). Each group will receive a different protein beverage     or placebo to consume following the resistance exercise training. Group 1 will consume a     beverage consisting of whey protein; group 2 will consume whey protein supplemented with     additional leucine; group 3 will consume whey protein supplemented with additional leucine     and hydrolyzed whey peptides; group 4 will consume whey protein supplemented with additional     leucine and citrulline; group 5 will just consume water. During the testing, blood and muscle     samples will be collected.   "
28032|NCT02918968|"     The objective of this study is to compare the efficacy and safety of the combination therapy     with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with     flutamide + ADT in patients with castration resistant prostate cancer who have relapsed     during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study will     also investigate the order of alternative antiandrogen therapy (AAT) by changing the 1st line     medication after relapse of prostate-specific antigen (PSA).   "
28033|NCT02918955|"     Treatment of regionally-advanced head and neck squamous cell carcinoma (HNSCC) requires a     multidisciplinary approach with a combination of surgery, radiotherapy (RT) and chemotherapy.     Due to these aggressive combined modalities, patients undergoing treatment and many survivors     develop toxicities which impact quality of life (QoL) and sometimes lead to mortality.      Lymph node metastases of HNSCC are frequent and considered one of the most important     prognostic factors, resulting in decreased survival by 50%. More than three decades, the     optimal management strategy of node positive HNSCC was a key subject of debate. In summary,     the current literature provides us two important findings: First, with the contemporary     imaging and treatment modalities, there is no role of a planned neck dissection (ND) added to     (chemo)radiotherapy ((C)RT) in terms of oncological outcome and survival. Second, with modern     RT techniques, a tailored treatment followed after an up-front neck dissection (UFND) allows     a significant reduction of treatment volumes and de-escalation of the dose to the neck,     leading to reduction of treatment related toxicities.      In this study strategies with and without up-front neck dissection prior to     chemo-radiotherapy will be compared.   "
28034|NCT02918929|"     This randomized, double-blind, placebo-controlled study will assess the safety, tolerability,     and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy     adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or     without prediabetes or T2DM).   "
28035|NCT02918916|"     Introduction: Recent studies have shown positive results from the application of phototherapy     for the improvement of performance and acceleration of the recovery process both in the     application before and after exercise. However, the effects of phototherapy during combined     training and after a primary adaptation process remain unclear.      Research objectives: The primary objective of the study is to analyze and compare the effects     of phototherapy using different light sources (laser and light emmiting diode - LED)     interacting with combined training on clinical, functional, and psychological outcomes and     vascular endothelial growth factor. The secondary objective is to compare the benefits     provided by phototherapy in participants with different levels of training adaptation.      Design: A controlled trial, double-blind, placebo-controlled will be conducted with     stratified randomization and concealed allocation.      Participants and Setting: After fulfilling the eligibility criteria, forty-five male     participants will participate in the study.      Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints     and squats). In phase 2, participants will be allocated, through stratified randomization     (based on adaptation capacity to training), into three groups: active phototherapy group     (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period     will then start. In this phase the participants will carry out training normally with the     adjusted loads and between sprints and squats will receive the recovery strategy related to     the group to which they belong.      Intervention: Active and placebo phototherapy will be applied by a trained therapist, between     sprints and squats. During the period of recovery strategies for the AG and PG, the CG     participants will remain seated for passive recovery, supervised by an independent therapist.      Measurements: The measurements include clinical, functional, and psychological outcomes and     vascular endothelial growth factor.   "
28037|NCT02918890|"     A randomized control trial examining the relationship between changes in hand function and     brain plasticity following intensive therapy. Two treatment approaches are used:     constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT).     The protocols have been developed at TC Columbia University to be child friendly and draw     upon our extensive experience with constraint-induced movement therapy in children with     cerebral palsy. Our center has been providing interventions camps for children with cerebral     palsy since 1998. The interventions are performed in a 15 day day-camp setting with several     children and at least one interventionist per child. The aim of the intervention is to     improve the use of the affected hand and quality of overall movement in a fun, social     setting. PARTICIPATION IS FREE. Please check out our website for more information:     http://www.tc.edu/centers/cit/   "
28038|NCT02918877|"     The purpose of this study is to investigate whether the use of inhaled anesthetics, compared     to intravenous anesthetics, can affect the amount of lung inflammation and postoperative     respiratory complications seen after cardiac surgery.   "
28039|NCT02918864|"     The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy of     integrating targeted dosing of intranasal oxytocin with a social cognitive skills group     therapy for school-aged children with autism spectrum disorder (ASD).   "
28040|NCT02918851|"     This is a single-center, randomized, partially blinded study to determine whether 42-day old     red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine     whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to     oxygen delivery.      In this study, subjects will be randomized to be transfused with 2 units of autologous (one's     own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in exercise     duration and VO2 max (test of oxygen consumption/delivery) between groups.   "
28041|NCT02918838|"     This study is an extension of Reminding Adolescents to Adhere (RATA) (Unique protocol ID:     1R01HD074925-01). Participants for SATA will be recruited during the RATA month 24 exit     survey.      Participants will be randomized 1:1:1 into either one of two intervention group (receiving     the weekly messages and a chance to draw a prize at each clinic visit based on either a fixed     adherence level of 90% or a self-chosen one of at least 80% as further detailed below) or the     control group that receives the existing RATA intervention consisting of weekly motivational     messages and the chance to get mobile airtime rewards conditional on responding. Doing so     will allow the investigators to cleanly evaluate the impact of these additional     adherence-based lotteries, and guarantees that those who have been in the control group     receiving standard of care in the first 24 months of the RATA intervention will also receive     an intervention for reasons of fairness.   "
28042|NCT02918825|"     A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the     treatment of 100 treatment- naive first-episode patients with schizophrenia.   "
28043|NCT02918812|"     This study compares the effect of intracervical block with 1% lidocaine and intramuscular     diclofenac 75mg in decreasing pain perception during hysterosalpingography. Half of     participants will receive intracervical block with 1% lidocaine, while the other half will     receive intramuscular diclofenac 75mg.   "
28044|NCT02918799|"     This project will adapt and pilot a multi-level, community-based intervention to promote HIV     prevention and sexual health among young men who have sex with men in Beirut.   "
28045|NCT02918786|"     The purpose of this study is to compare the effect of continuous positive airway pressure     (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula     oxygen therapy in mechanically ventilated patient who are at risk for postextubation failure.   "
28046|NCT02918773|"     Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause     of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM     is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear     canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the     tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic     membrane including capturing still images and recording video of the ear exam would be     beneficial in the diagnosis and management of otic complaints, including acute and chronic     otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to     manage otic complaints, visualize the tympanic membrane, and support antimicrobial     stewardship. This study will be conducted as a randomized control study in two affiliated     children's hospital emergency departments. Twenty volunteer clinicians will be randomly     assigned to use either a smartphone otoscope or a conventional otoscope for all otic     examinations for a 6-month period.   "
28047|NCT02918760|"     Aim :The aim of this study is to evaluate the efficacy of oral Gabapentin in the treatment of     chronic pelvic pain in females.      The study is designed as a randomised, placebo-controlled, clinical trial.32 patients will be     enrolled each arm.      Group A (cases):      This group will include (32) women according to inclusion and exclusion criteria and will     receive a card of Gabapentin which will be taken orally by the patient at home three times     daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain     relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia.     Group B (controls):This group will include (32) women .      Assessment of the patient's pain during the physical examination will be done using the     Visual Analogue Scale (VAS). The patient will be asked to place a mark on a drawn 10 cm line     at a point which is corresponding to the intensity of her pain. One end of the line denotes     no pain and the other end of the line indicates that pain is as bad as it can be (the worst     pain).the distance in cm from the low end of VAS to the patient's mark will be used (it gives     a number.Questionnaire: will be given to all participants at randomization (0 months) , at 3     months and at 6 months to assess the degree of pain improvement via VAS.      Patients' overall satisfaction with their pain treatment &Side effect recording (e.g.,     dizziness, somnolence, mood changes, appetite and poor concentration).   "
28048|NCT02918747|"     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's     lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm     prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen     achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study     to compare the efficacy of these two regimens. This prospective pilot study to compare the     efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen for     stage IE to IIE ENKTL.   "
28049|NCT02918734|"     In this randomized controlled trial the investigators will compare the results after primary     anterior cruciate ligament (ACL) reconstruction using two different methods for femoral     fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the     standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have     been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become     available and the clinical results have been described as promising; however, no randomized     controlled trials comparing these two femoral fixation methods have been conducted, and there     is no published data that confirms that the bone block heals in the tunnel with the newer     method.      The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB     autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.   "
28050|NCT02918721|"     The purpose of this study is to evaluate the pain and safety associated with injections of     Restylane Lidocaine compared to Restylane using a visual analogue scale.   "
28303|NCT02915224|"     This multicenter, single arm, non-interventional, observational study will evaluate the     efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic     lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total     length of the study is 42 months.   "
28051|NCT02918708|"     The National Vaccine Evaluation Consortium conducts Department of Health funded trials trials     to provide information to underpin changes to the national immunisation and vaccination     schedule.      This study will assess how different schedules of pneumococcal conjugate vaccines work in     providing protection to young infants. It is well established that vaccines can behave     differently depending on which order they are given and alongside which other immunisations.     This has been shown for Hib and MenC vaccines, which are similar in structure to the     pneumococcal vaccines that will be studied here. The investigators will measure responses to     the pneumococcal vaccines as well as to other routine immunisations, all of which will be     provided by our study team. Infants will be recruited by dedicated study staff through     primary care and will participate from their first vaccinations at 2 months of age, until the     blood sample taken a month after their boosters at a year old, i.e. until 13 months of age.      Any child found to have antibody levels below that which indicates protection for Hib, MenC,     MenB or pneumococcal in the blood sample taken at 13 months of age will be offered an extra     dose of the relevant vaccine(s).   "
28052|NCT02918695|"     The purpose of this study is to compare clinical judgment and comprehensive geriatric     assessment as screening tools for optimization of treatment for newly diagnosed elderly     multiple myeloma patients.   "
28053|NCT02918682|"     This study evaluates if a multi-component intervention, respecting the characteristics of     frail older person and increasing intensity and challenge of exercises according to frail     older person capacity/evolution will induce better functional results than a multi-component     intervention specific to lower body. the volunteers will be randomized into experimental     group and control group.   "
28054|NCT02918669|"     Examine the long-term survivorship via CT Scan of the coflex in patients who presented with     spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.   "
28055|NCT02918500|"     This study will determine whether or not patients who use a Nicotine Replacement Therapy     (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after     their surgery and have fewer post-operative complications   "
28056|NCT02918487|"     The aim of this trial is to study the effect of a polyherbal capsule containing four herbs:     Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of     bronchial asthma.   "
28057|NCT02918474|"     An online decision support tool will be field tested that provides patients facing a decision     about contralateral prophylactic breast cancer (CPM) with evidence-based information about     the expected incidence of contralateral breast cancer and the life expectancy benefit of CPM.     The tool will be designed for use in clinical settings and viewed jointly by the patient and     physician as part of a shared decision making process around CPM.   "
28058|NCT02918461|"     At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a     6-week psycho-educationally-based, cognitive behavioral program to help patients with     subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™     (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.      The objective of this study is to quantify the impact of a trainee-taught Emerging from the     Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the     change of FACT-Cog score.   "
28059|NCT02918448|"     Metabolic syndrome (MetS) is a multicomponent disorder closely linked to low grade     inflammation, and cardiovascular disease (CVD). The aim of this study was to investigate the     effects of a 12-week resistance training (RT) program on body composition, risk factors for     metabolic syndrome (MetS), and inflammatory biomarkers in older adult women   "
28060|NCT02918435|"     This research project is aimed to assess the implementation, effectiveness, and     sustainability of a pediatric-based intervention aimed at reducing families' unmet material     needs (food, housing, employment, childcare, household heat, education) in pediatric     practices throughout the United States.   "
28061|NCT02918422|"     To determine the effects of high cheese diets varying in carbohydrate content on markers of     disease risk.   "
28062|NCT02918409|"     The purpose of this study is to find the safest and most effective way to administer IV     antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis     (CF) that are caused by pathogens, like Pseudomonas aeruginosa. This study will test the     safety and effectiveness of two commonly prescribed IV antibiotics: tobramycin and colistin.     Though regularly used, not much is known about how these drugs compare with each other in     terms of their toxicities, both during short term treatment of an APE and after many     treatment courses with these drugs over many years. There are currently no guidelines on the     safest and most effective antibiotics to use when treating APEs. We will study kidney     function, sputum cultures, and treatment outcomes in patients receiving routine     administration of one of these two IV antibiotics. We will also test these outcomes in     patients receiving a less frequent dosing schedule for IV colistin. The hope is that this new     schedule for IV colistin, which is twice a day and adjusted based on blood and urine tests,     will reduce harmful side effects, such as kidney damage, while still being a powerful     treatment against CF microbial pathogens.   "
28314|NCT02915081|"     The investigators hypothesize that subjects undergoing liver resection and who are exposed     preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury,     specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent     light.   "
28088|NCT02918071|"     The purpose of the study is to assess functionality, performance, and reliability of an     single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an     at-home setting reported by the patient or caregiver, and to confirm the safety and clinical     benefit of benralizumab administration in asthma patients with severe asthma   "
28109|NCT02917798|"     This study will evaluate patients' experiences with having gynecologic or prostate medical     oncologists and surgeons offer them genetic testing, and having genetic counselors return the     test results to patients over the telephone. This is different from the usual approach to     genetic testing, where gynecologic or prostate medical oncologists and surgeons refer their     patients to a genetic counselor in order to have these tests done, and the genetic counselors     return the test results to the patient in person or over the telephone. The investigators     will only be evaluating this alternative way of providing genetic testing to ovarian or     prostate cancer patients.   "
28063|NCT02918396|"     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with increasing     morbidity and mortality. A catheter-based AF ablation technique that isolates pulmonary veins     (PV) from the left atrium has been established to disrupt AF. Despite significant     development, AF ablation with pulmonary vein isolation (PVI) is reported to have a success     rate of 40-80% in various AF populations.      Persistent AF appears to be more reliant upon fibroblast proliferation and myocyte-fibroblast     coupling than paroxysmal AF with obvious implications on its management. Despite the     knowledge that fibrotic substrate is responsible for the perpetuation of persistent AF,     several ablation techniques targeting these extra-pulmonary veins sites have failed to prove     an additional benefit to PVI alone. Nevertheless, two recently developed technologies, aimed     at detecting AF substrate with high precision, seem to constitute a potential breakthrough in     the management of persistent AF. On one hand, late gadolinium-enhanced MRI (LGE-MRI) is a     well-established method to identify fibrosis in the myocardium. Recent reports from a single     center have shown that MRI-based left atrial fibrosis detection is able to predict the     outcome of the procedure. Hence, targeting lesions seen on LGE-MRI in the setting of     persistent AF is an option yet to be explored and compared to the widely adopted, yet     suboptimal, PVI. On another hand, a novel ablation method with promising results is focal     impulse and rotor modulation (FIRM). Undergoing wide sampling of the atria with     spatiotemporal and computational mapping while in AF has identified areas with stable     organized rotational electrical activity (rotors). Several studies are under way to prove the     reproducibility of rotor mapping, with more groups reporting improved rates of acute and     long-term suppression of AF with ablation of FIRM-identified rotors.      The SIMPle AF study will be a randomized clinical trial designed to test the hypothesis that     ablation tailored to the underlying substrate using either LGE-detected dense scar or rotor     anchor sites predicted by computational modeling is superior to anatomic non-tailored PVI     ablation in patients with persistent AF. For the present study, the investigators plan to     enroll a total of 30 patients.   "
28064|NCT02918383|"     Laser Angiography using indocyanin green (ICG) is a relatively new technique and has been     utilized to assess the viability of soft tissue, most prominently in the general surgery and     plastic surgery literature. This technique has been used for prediction of soft tissue     viability by assessing the perfusion status. There is currently no Orthopaedic literature     regarding the use of this device for assessment of subchondral perfusion of articular     surfaces such as the distal femur or other chondral surfaces.      In this pilot study, the use of ICG to detect the perfusion status of a distal femur and     proximal tibia during a surgical approach to the knee and correlating this to visible signs     of arthritis. For example, due to the difference visible with ICG angiography correlate to     gross changes in the cartilage health visible to the naked eye with radiographic imaging.   "
28065|NCT02918370|"     The investigators will conduct a 12-week, randomized, double-blind, parallel-group,     placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and     bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess     change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include     change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in psychiatric     symptoms (mania/hypomania and depression) and predictors of response will be assessed.     Participants with ≥ 1 drinking day at week 12 will be enrolled in a 4-week extension phase     with an upward titration to 30 mg/day for those in the active treatment group. The placebo     group will remain on placebo.      Subjects will be discontinued from the study if any of the following conditions occurs:     change in diagnosis to other than bipolar I or II disorder and AUD, development of active     suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the     opinion of the investigators requires discontinuation, pregnancy, development of severe or     life-threatening medical condition, involuntary psychiatric hospitalization or incarceration,     significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases     in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores will initiate a     careful clinical assessment of possible worsening of withdrawal symptoms), or cocaine or     amphetamine-positive urine drug screen during the study.   "
28066|NCT02918357|"     The investigators are imaging patients with prostate cancer using a new PET imaging agent     (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients     with biochemical recurrence after prostatectomy and radiation therapy.   "
28067|NCT02918344|"     The goal of this study is to determine if the use of calcium phosphate paste in mandibular     lengthening surgery causes more complications as surgical site infections and hardware     removal.      An evaluation will be made to determine if the benefits of the use of the paste     (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the     disadvantages.   "
28068|NCT02918331|"     The purpose of this study is to evaluate the safety of daratumumab when combined with     lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma     who are not candidates for high-dose chemotherapy and autologous stem cell transplantation     (ASCT).   "
28069|NCT02918318|"     The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine     compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese     participants with treatment-resistant depression (TRD), in improving depressive symptoms.   "
28070|NCT02918305|"     The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which     aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise® in Europe)     for renal denervation therapy in patients with treatment resistance hypertension, in     comparison with the sham procedure.   "
28072|NCT02918279|"     This trial is conducted globally. The aim of this trial is to investigate the effect of     liraglutide for weight management in pubertal adolescent subjects with obesity.   "
28073|NCT02918266|"     The purpose of this study is to assess the effect of a single oral dose of TAK-071 on the     attenuation of cognitive deficit induced by scopolamine as measured by Groton Maze Learning     Test (GMLT) (total number of errors).   "
28083|NCT02918136|"     This is a prospective, randomized, multi-site, safety and efficacy study in subjects with     rotator cuff injuries.      Patients will fall into two categories: treatment group (12 subjects) and non-treatment or     control group (six subjects). The treatment group will undergo a small liposuction procedure     and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc     adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a     5cc cortisone injection into the point of injury   "
28084|NCT02918123|"     Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to     severe in plaque-type psoriasis injection for 4weeks.   "
28107|NCT02917824|"     Inspiratory muscle training (IMT) can reverse or delay the complications from the     deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a     treatment option for people with asthma. The aim of this study is to investigate the training     principles of intensity, specificity and reversibility of IMT in asthmatics.   "
28074|NCT02918253|"     Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer,     traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR)     brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment     schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence     adverse effects including urinary, rectal, and sexual toxicities that affect the patient's     quality of life.      This study will incorporate HDR monotherapy treatment option for early stages and favourable     risk prostate cancer.      Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease     based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the     treatment toxicities while maintaining oncologic outcomes when compared with whole-gland     therapy. Advantages in quality of life could be exhibited in the form of reduced urinary     discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland     function. This study would be particularly relevant in the current era of earlier localized     prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine     component of patient care.   "
28075|NCT02918240|"     Fixed orthodontic braces are routinely used to straighten teeth and correct the bite of     individuals. Once the braces are fit, the patient is recalled every few weeks to adjust or     tighten the brace. Although convention states that the patient returns every 6-8 weeks to     have the brace adjusted, there is no consensus or evidence to support a specific timeframe.     Indeed some orthodontist see their patients as frequently as every 4 weeks and others as long     as every 10 weeks. The aim of this investigation is to determine whether the amount of time     between brace adjustment appointments has an effect on the overall treatment time. Knowing     which appointment interval will lead to the shortest overall treatment time will be of     benefit to patients as prolonged orthodontic treatment may be associated with an increased     incidence of adverse effects associated with orthodontic treatment.      Patients who are to be treated with fixed orthodontic braces at will be invited to take part     in the study. Consenting subjects will be randomly allocated into one of four groups. The     first will be seen to adjust their brace every 4 weeks, the second group every 6 weeks, the     third group every 8 weeks and the fourth group every 10 weeks.      The primary outcome measure is the total treatment time. The mean treatment time of each of     the four groups will be compared to establish whether or not treatment appointment intervals     affects treatment time.      Secondary outcome measures will include difference in number of appointments required     throughout the course of treatment between groups, differences in treatment outcomes,     differences in patient compliance.   "
28076|NCT02918227|"     Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia     (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized     what constitutes the main constraint for patients. Empirically, the investigators talk to the     patient retrograde ejaculation to explain a possible loss of ejaculation. Yet the     underlying mechanism of this modification or loss of ejaculation remains completely unknown.     Yet the underlying mechanism of this modification or loss of ejaculation remains completely     unknown. No study could not determine whether the predominant mechanism was a real retrograde     ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve     antegrade ejaculation but no scientific rationale can not validate.   "
28077|NCT02918214|"     Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a     left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume     overload. Recently, a meta-analysis suggested a negative prognostic role of LV diastolic     dysfunction in septic patients (Od Ratio: 1.82; 95%CI: 1.12 - 2.97; p = 0.02) but its     external validity is hampered by the numerous limits and the heterogeneity of the studies. To     date, a pathophysiological link between LV diastolic dysfunction associated with septic shock     and the water balance (reflecting volume overload) remains to establish. In addition, small     size studies reported an excess of mortality in patients with septic shock who were diagnosed     with a high cardiac output. However, no large cohort has yet confirmed the negative     prognostic role of a hyperkinetic hemodynamic profile at the initial phase of septic shock.   "
28078|NCT02918201|"     After surgical procedures, interventions to reduce postoperative bleeding are of great     importance. In this study, the effect will be investigated of administering tranexamic acid,     which is designed for injection, directly onto the raw wound surface (topical application)     created during surgery. In this way only a small amount of drug is to reach a large wound     area. There will be a higher drug concentration of it in the exposed wound surface than after     injection, but only a very low concentration in the body, and no risk of injury from needles.     The researchers have recently shown that topically applicated tranexamic acid reduces     bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether     topically applicated tranexamic acid reduces bleeding and wound effusions from superficial     wounds, using as a study model the homogenous wounds created by tangential skin excision when     harvesting split skin grafts for skin transplants. Two identical wound surfaces in the same     patient will serve as case and control.   "
28079|NCT02918188|"     This study suggested that hydrogen has a potential as an effective and safe therapeutic agent     on cGVHD.   "
28080|NCT02918175|"     The overall objective of this study is to test a personalized mHealth intervention designed     to increase physical activity and improve medication adherence in subjects with heart failure     and diabetes mellitus. The study will leverage consumer technology as both an intervention     and as a tool for data collection.   "
28081|NCT02918162|"     To determine and evaluate the efficacy of combination therapy with immune checkpoint blockade     and chemotherapy used in the perioperative period in eradicating micrometastatic disease.      To compare paired tissue and serum samples (pre-treatment and post-treatment) from     individually treated patients to explore the immune effects of combination therapy and     predictors of response.   "
28082|NCT02918149|"     Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as     a method to improve success but it is not known if it helps. This study is designed to see if     ultrasound improves the success rate.   "
28085|NCT02918110|"     The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal     slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.   "
28110|NCT02917785|"     the purpose of this study is to examine the success rates of Karman curettage in completing     the abortion after failed recurred treatment with Misoprostol for women with missed abortion.   "
28089|NCT02918058|"     Potentially inappropriate medications (PIMs) can lead to adverse drug events (ADEs) among     older adults and especially those classified as frail. ADEs are responsible for nearly 27,000     hospital admissions in Canada annually. Within 30 days of discharge, medications contribute     to two-thirds of adverse events, with nearly 60% being preventable or ameliorable. MedStopper     is a Canadian Institutes of Health Research-funded software product that guides patients and     physicians in the community through the process of deprescribing. MedStopper has been     upgraded to a research application for the purposes of this study and now electronically     cross-references patient comorbidities with the most recent evidence-based PIMs as of 2016,     in order to generate a patient-tailored deprescribing care plan. This study will evaluate     whether this application, when applied at hospitalization, leads to a reduction in the     proportion of PIMs prescribed at 30 days post discharge, by highlighting harmful medications     for deprescription to treating physicians. This study will take place on the clinical     teaching units (CTUs) at four hospitals. Based on historical records, the investigators     estimate enrolling 480 patients aged 65 or older over three months. A trained research     assistant will identify eligible patients, and will enter their medications, comorbidities,     and an estimate of frailty into MedStopper. A deprescribing plan will be generated for the     CTU team containing rationale for suggested medication changes and strategies for safe and     successful deprescription. The CTU team will then decide in conjunction with the patient or     proxy, and with relevant consultants, which medications can rationally be stopped or tapered     at discharge.   "
28090|NCT02918045|"     The purpose of this study is to compare two hemostatic agents in patients under dual     antiplatelet therapy using the intraoral bleeding time after dental extractions.   "
28091|NCT02918032|"     This study aims to understand the state of onset of NLSD(neutral lipid storage disease) /     TGCV(triglyceride deposit cardiovasculopathy) worldwide, background information of affected     patients, and natural history of the disease, as well as exploring the prognostic factors and     assessing the efficacy of disease-specific treatment.   "
28092|NCT02918019|"     This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm     study will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo     as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium-     or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following     additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier     (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The     total duration of this study for each participant is approximately 70 weeks including     screening, run-in, treatment, and follow-up.   "
28093|NCT02918006|"     A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009     (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based     Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.   "
28094|NCT02917993|"     The purpose of this study is to evaluate the safety and tolerability of INCB039110 in     combination with osimertinib in subjects with locally advanced or metastatic non-small cell     lung cancer (NSCLC).   "
28095|NCT02917980|"     This project aimed to optimize the therapeutic strategy for structural heart disease by     choosing optimal treatment, such as,surgical treatment,interventional and surgery combined     with interventional hybrid treatment. Thereby improve successful rate of clinical treatment,     and establish the guideline for treatment of structural heart disease.At the same time,online     registration database for structural heart disease will be established to further data     analysis and objective assessment of clinical curative effect for structural heart disease in     China.   "
28096|NCT02917967|"     This is a longitudinal, prospective, and open-label interventional study in a single center.     We will investigate the effect of single injection in each patient. This study was designed     to establish the clinical evidence for effect of botulinum toxin type a (Dysport,     abobotulinum toxin A) injection on changes in musculotendinous length and dynamics of     hamstring muscles during gait in children with spastic cerebral palsy walking with excessive     knee flexion.      Baseline data such as Modified Ashworth scale (MAS), Modified Tardieu scale (MTS), Gross     Motor Function Measures (GMFM), and Gross Motor Function Classification System (GMFCS) level     will be assessed. Gait analysis will be performed using a computerized gait analysis system     (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the     kinematic data (angle of each joint) during the gait cycle. A trained investigator will place     14 reflective markers on the anterior and posterior superior iliac spine, the mid points of     the lateral femur, the lateral knee joint axis, the midpoints of the lateral tibia, the     lateral malleolus, and the dorsal foot between metatarsal heads 2 and 3. All subjects should     walk barefoot at a self-selected speed along an 8-meter path with the markers in place and     the motion will be captured with a 100-Hz sampling frequency. Force-plates (AMTI OR 6-5,     Advanced Mechanical Technology, Newton, MA, USA) under the path will record ground reaction     forces during the walking trials with a 1000-Hz sampling frequency, and joint moments will be     expressed as internal moments to counter the ground reaction forces. Data collection will     continue until the subject achieved at least 3 'clean' force-plate strikes. Kinematic and     kinetic data from successful trials will be used for statistical analysis. Video recording     will be done simultaneously from the front, rear, and side, with the 3D gait analysis.   "
28119|NCT02917668|"     This study aims to evaluate the risk of hyperoxia-induced hypercapnia in post-op obese     cardiac surgery patients. It will compare two oxygenation modes in terms of their effect on     the arterial partial pressure of carbon dioxide (PaCO2) : manual titration of oxygen delivery     for a peripheral oxygen saturation (SpO2) target of > 95 % versus automatic titration by a     closed-loop system for a SpO2 target of 90%. 15 post-op obese cardiac surgery patients will     be recruited and each will receive both interventions (cross-over design). The main outcome     will be the PaCO2, which will be compared after each study period. The research hypothesis is     that the usual SpO2 target of > 95 % is associated with a greater PaCO2 compared with a     lesser SpO2 target of 90%.   "
28098|NCT02917941|"     The purpose of this study is to evaluate the efficacy and safety of ixazomib plus     lenalidomide and dexamethasone in Japanese patients with relapsed and/or refractory multiple     myeloma.   "
28108|NCT02917811|"     The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU     mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in     specific subgroup population with some clinical characteristic wich may modify RDW baseline     values, i.e. transfused patients or patients with high markers of hemolysis   "
28111|NCT02917772|"     TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional     nivolumab/ipilimumab boost cycles in previously untreated and pretreated (2nd line),     advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk     disease according to IMDC.   "
28099|NCT02917928|"     The investigators hypothesise that carnosine supplementation will improve:        1. glycaemic control        2. cardiovascular risk factors        3. cognitive outcomes      in patients with prediabetes and type 2 diabetes, and this will be modulated by reduction in     chronic low grade inflammation, oxidative stress and circulating advanced glycation end     products levels.      3. Aims      To determine the potential of carnosine supplementation for 14 weeks to improve glycaemic     control in type 2 diabetes, reduce risk factors for cardiovascular disease and improve     cognitive function as well as identify metabolic pathways involved, specifically by:        1. Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under          the curve after oral glucose tolerance test)        2. Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central blood          pressure (cBP); endothelial function).        3. Improve cognitive function (global cognitive score formed by a composite of 4 cognitive          tests)        4. Decrease the chronic low grade inflammation, oxidative stress, advanced glycation end          products, and advanced lipoxidation end products, and increase detoxification of          reactive carbonyl species (RCSs).   "
28100|NCT02917915|"     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by     smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and     comprehensive intervention for COPD patients that includes patient assessment, exercise     training, and self-management education to promote behavior changes. PR has been shown to be     the most effective strategy to improve clinical health outcomes, and is now considered to be     a standard of care intervention for individuals with COPD who remain symptomatic despite     optimal drug therapies. Despite considerable evidence supporting the effectiveness of PR at     enhancing clinical outcomes, it is unclear if PR influences the behaviors that promote COPD     management (i.e., physical activity, medication adherence, self-managing exacerbations).      In collaboration with the local clinical staff as well as national colleagues and the     Canadian Thoracic Society, a new national pulmonary rehabilitation program has been     co-developed that is designed to increase physical activity, medication adherence, and skills     to help manage chronic lung diseases. The new program aims to increase people's confidence     and autonomy for performing disease-management behaviors, and has been designed to be more     effective at increasing physical activity, medication adherence, and disease management     skills than previous pulmonary rehabilitation programs. The program is designed to be     delivered within different settings of practice, including traditional PR centers, satellite     sites (i.e., sites that are remote from the major institutions),with the use of Tele-health     and web-based resources, and primary care medical centers. The effectiveness of the new     Standardized Canadian PR program will be assessed relative to the traditional PR program.     This trial is an important step towards establishing the necessary evidence that will then     enable us to work on dissemination and implementation of this new standardized PR program     across the country.   "
28101|NCT02917902|"     To compare the effectiveness of providing monthly boxes of nutritious foods to low-income     patients with diabetes on site at Free Clinics with referrals to off-site food pantries on     diabetes related health outcomes   "
28102|NCT02917889|"     Check the acute influence of caffeine on the autonomic modulation and cardiorespiratory     parameters after aerobic exercise. Hypothesized that caffeine can promote a slower recovery     of the cardiorespiratory parameters and the SNA recovery after aerobic exercise.   "
28103|NCT02917876|"     This study seeks to understand the physical, physiologic and biologic features that     predispose a woman to the development of obstructive sleep apnea once they are exposed to the     cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific     predictive factors can help identify a population at risk and guide clinicians to develop     suitable targeting screening strategies.   "
28104|NCT02917863|"     Thyroid disorders, in particular hypothyroidism, are associated with gastrointestinal     impairment, such as celiac disease. A study reported an increased prevalence of celiac     disease in a large cohort of children affected by congenital hypothyroidism, underlying the     relationship between these two conditions. The hypothesis of our study is that the onset of     celiac disorder may be related to the gut concentration of thyroid hormone (TH) in     hypothyroidism patients treated with replacement therapy. In fact, TH replacement therapy     showed a low bioavailability with a consequent high gut concentration. Two different     pharmaceutical formulations (liquid and solid, per os) are available. The liquid one has a     better absorption profile and bioavailability than the solid; therefore, it is associated     with a low TH intestinal concentration. According to our hypothesis, the solid TH formulation     could increase the microbial diversity in the gut instead of the liquid form, due to the high     local TH concentration. Based on these findings, the purpose of this study is to evaluate the     effect of two different pharmaceutical formulations of TH on the gut in terms of modification     of gut microbiota, inflammatory parameters and gut absorption.   "
28105|NCT02917850|"     Post-stroke patients often present with gait disorders due to several physical impairments.     Hip flexor deficit is one of the more prevalent trouble and is associated with gait     capacities. This study aims at evaluating the impact of an isokinetic hip flexors     strengthening rehabilitation program in the subacute phase after stroke. Patients will be     randomized to an intervention group (isokinetic rehabilitation) or a control group     (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3 and     at 6 months.   "
28140|NCT02917395|"     Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with     disopyramide.      Tow echo examination, few hours apart, that includes strain rate will be done to each     patient. The first, after taking the regular medical treatment excluding disopyramide and the     last one after taking the disopyramide.   "
28106|NCT02917837|"     Diagnostic imaging (DI) tests (for example, x-ray tests, ultrasounds, CT scans, or MRIs) are     used by health care providers to help diagnose patient illness, but decisions regarding when     these tests should be ordered are subjective. As a result, some physicians order these tests     more than others. Ordering rates between clinicians seeing similar kinds of patients have     been shown to be considerably different, suggesting that many of the tests are unnecessary.     DI currently accounts for about 6.6% of Canadian hospital budgets, but this percentage may be     much higher in Newfoundland where test ordering rates are almost twice the national average.     However, cost is not the only concern. Over-testing can lead to further unnecessary testing     to follow-up on harmless findings, and in the case of CT, large doses of potentially harmful     radiation. The purpose of this study is to assess DI test-ordering by family physicians     across the Eastern Health region, and compare these test ordering rates with those from other     jurisdictions. We suspect that many clinicians are not aware that they order more DI tests     than their peers. We will therefore develop a report card for family physicians in the     province that shows them how many tests they are ordering compared to other physicians in the     region. We expect that physicians who are over-ordering DI tests will reduce the number of     tests they order after receiving their report cards. This is a low-cost way to potentially     prevent expensive over-ordering of DI tests that can easily be implemented in the province's     other health regions and elsewhere.   "
28113|NCT02917746|"     This multi-center, open-label, non-randomized controlled intervention study aims to     investigate the treatment efficacy, side-effects and quality of life associated with     imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by     Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent     side-effects associated with surgical treatment, such as premature birth in subsequent     pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN     will be adequately treated with imiquimod.      120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one     of two treatment arms according to their preference:        1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal          imiquimod 5% cream during 16 weeks.        2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ          treatment.   "
28114|NCT02917733|"     This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has     been specially prepared to contain radiolabeled carbon [¹⁴C]. [¹⁴C] is a naturally occurring     radioactive form of the element carbon. This study will help determine how the drug appears     in the blood, urine, and stool after it is administered by mouth to healthy people.     Information about any side effects that may occur will also be collected. This study will     last about 10 weeks for each participant.   "
28115|NCT02917720|"     The main goal of the study is the assessment of duration of major molecular response (MMR) or     better at 12 and 36 months after stopping tyrosine kinase inhibitors (TKI) therapy a second     time in patients with at least three years prior TKI treatment comprising at least two years     of nilotinib treatment within this trial and maintained stable MR4 (BCR-ABL ratio <0,01% on     international Scale (IS) for at least one year and MR4.5 (BCR-ABL ratio <0,0032% on IS) for     at least 6 months:        -  who failed a first stop in the EURO-SKI study (standardized criteria)        -  who failed a first stop outside the EURO-SKI study but would have had fulfilled same          eligible criteria and were stopped according to EURO-SKI rules        -  who failed a first stop outside the EURO-SKI study without fulfilling EURO-SKI rules   "
28116|NCT02917707|"     The investigators will perform integrative analysis of CRC liver metastasis   "
28117|NCT02917694|"     This study aims to assess the feasibility of obtaining details about a patients previous     level of function from the patient of friend/relative, after they have been admitted an     intensive care unit (ICU). It will also assess the feasibility of re-assessing level of     function at 6 months after the patient has been discharged from ICU.   "
28118|NCT02917681|"     The study aims to evaluate primarily safety of two injections of autologous mesenchymal stem     cells in Amyotrophic Lateral Sclerosis patients. Secondary outcomes of efficacy will also be     evaluated   "
28373|NCT02914314|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of an oral suspension of     perampanel given as an adjunctive therapy and to generate preliminary safety and efficacy     data in pediatric participants, ranging from 1 month to less than 24 months of age, with     epilepsy.   "
28120|NCT02917655|"     BACKGROUND: Osteoarthritis (OA), and particularly knee osteoarthritis (KOA) is a disorder     that greatly impairs the quality of life of patients and its incidence increases with     longevity, obesity and lower socioeconomic and educational level. It is expected that 40% of     people over 60 have symptomatic OA of the knees and hips. The core treatment of OA is     education, weight loss and increased physical activity. We create an educational program that     improved function of the patients given by the five-times-sit-to- stand test (FTSST).     However, weight loss, an important foundation of clinical treatment, was only effective (more     than 2 points in BMI) in 10% of the program participants. For greater effectiveness in weight     loss and adherence to physical activity, we prepared an intensive program with more intensive     nutritional care, psychological, physical therapy and physical trainers and compare the     existing program educators. OBJECTIVE: To compare an educational program isolated to an     educational program associated with nutritional consultations, group therapy sessions and     progressed physiotherapy sessions to sessions with physical educators in patients with KOA     and comorbidities (metabolic syndrome).      METHODS: Ninety patients with OAJ and co-morbidities (Two or more of: overweight or obesity,     hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will be divided into two     groups: study (S) and control (C). Both groups will attend the two-day multi-professional     classes on OA with two months interval. But the study group will also make three group     consultations about nutrition, 1 extra session of group therapy with psychology team and 7     exercise sessions in groups with physical therapy and subsequently 7 sessions with physical     educators. The groups will be evaluated for weight, height (to calculate BMI), waist-hip     ratio, percentage of body fat, consumption of daily medications, WOMAC, Lequesne, IPAQ, Tampa     Scale for Kinesiophobia (TSK), test sits and rises, timed-up- and-go (TUG) and six minute     test. At inclusion, six, twelve and 24 months after the classes.   "
28121|NCT02917642|"     The purpose of this clinical study was to compare the effectiveness of passive ultrasonic     irrigation with that of traditional syringe irrigation on the removal of bacteria and     endotoxin (lipopolysaccharide [LPS]) from root canals.   "
28122|NCT02917629|"     This randomized phase IIb trial studies how well ACTOplus met XR works in treating in     patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive     treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from     forming or coming back. The use of ACTOplus met XR may slow disease progression in patients     with oral cavity or oropharynx cancer.   "
28123|NCT02917616|"     This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on     the gut microbiota of healthy male volunteers.   "
28124|NCT02917603|"     Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has     found the quality of care of end-of-life care in nursing homes to have many challenges. It     has also been documented that family members, especially those living at a distance, want to     be involved in the care of their resident and family support can be beneficial to residents.     Family members' involvement in decision-making in the nursing home setting improves outcomes     for residents with life-limiting illnesses. Shared decision-making is a process wherein a     healthcare choice is jointly made by a healthcare provider and a resident or resident's     proxy, often a family member. This proposal seeks to facilitate SDM among family members,     residents with life-limiting illnesses (who are not enrolled in hospice), and the nursing     home care team. The overall research question (RQ) asks: To what extent are outcomes for     family member and residents with life limiting illnesses associated with SDM via     web-conferencing in the nursing home? The overall hypothesis (H) is that SDM among family     members, residents (when possible), and skilled nursing home staff via web-conferencing will     improve outcomes for family members and residents with life-limiting illnesses. This is an     exploratory mixed methods randomized clinical trial pilot to test the effect of shared     decision making using web-based conferencing on the depression and burden of family members     and the pain of nursing home residents.   "
28126|NCT02917577|"     The study is a prospective, single centre, double-blinded randomized controlled trial whose     goal is to compare the immune response of a population of immunosuppressed pediatric     rheumatology patients on immunosuppressive medications to two different doses of Hepatitis A     vaccine. The objectives are (a) to confirm that adolescents, like their adult counterparts,     have a reduced immune response to hepatitis A vaccine, and (b) to compare the immunogenicity     of two different dosing options of vaccine for this age group after one and two doses. A     total of 60 adolescents aged 12 - 15 years with confirmed chronic rheumatologic conditions     for which they are being treated with an immunosuppressive therapy will be recruited from the     Rheumatology Clinic at Alberta Children's Hospital (ACH). Those found to have no immunity to     hepatitis A will be enrolled. Informed, written consent will be obtained from the parent or     guardian of subject, with assent obtained from the study subjects. Subjects will be randomly     assigned to two doses of either Avaxim Pediatric® or Avaxim ® (adult) vaccine (Sanofi Pasteur     Canada), six months apart, with hepatitis A titres done at baseline and one month after each     dose. Both formulations are licensed for this age group.   "
28127|NCT02917564|"     During glaucoma surgery, a new opening is created that allows fluid to drain out of the eye,     bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. In     some patients who have had glaucoma surgery too much fluid flows out and this results in a     pressure that is too low. This may cause swelling of one layer at the back of the eye called     the choroid. The formation of this swelling, called a choroidal effusion or choroidal,     often makes the eye pressure stay too low, and one of the results is a decrease in vision.     The treatment for a choroidal effusion is to try to raise the eye pressure somewhat to allow     the swelling to subside. In our clinical work, we have found that an injection with an     anti-inflammatory drug called triamcinolone appears to be helpful in speeding up healing. We     plan to compare two groups of patients with choroidal effusions, one group that gets an     injection of triamcinolone and one that gets a sham treatment with nothing injected and     compare the length of time it takes the choroidal effusions to disappear. Both groups receive     the standard treatment with eye drops. We will also assess the outcome of the glaucoma     surgery and any other complications that may occur. This research is aimed at studying a new     method of improving the outcomes of surgery for glaucoma patients, and further the treatment     of glaucoma.   "
28153|NCT02917239|"     Overall survival of multiple myeloma (MM) patients has increased significantly due to the     availability of the new drugs. Moreover, since MM is an incurable disease, patients are     exposed to repeated lines of therapy with different agents. It is therefore increasingly     important to monitor the long-term side-effects of treatments. In the present study we     focused on ocular disorders. This is an observational study aiming to assess the prevalence     of ocular disorders in 100 patients on treatment or follow-up for MM.   "
28128|NCT02917551|"     The burden of bloodstream infections is large and increasing over time. Antibiotic overuse     continues to drive increased rates of antimicrobial-resistant pathogens across Canada.     However, prospective audits have revealed that 30-50% of antibiotic utilization is     unnecessary or inappropriate. If shorter duration therapy is as effective as longer duration     therapy for these infections, antimicrobial consumption would be decreased. A pilot trial     (approved by the Sunnybrook Research Ethics Board), is underway in critically ill patients at     17 Canadian ICUs. Investigators have successfully demonstrated feasibility with respect to     protocol adherence and recruitment rates in the ICU. Investigators now aim to conduct a     similar pilot RCT among non-ICU patients admitted to hospital wards with bloodstream     infections to determine feasibility and protocol adherence of the same trial protocol.   "
28129|NCT02917538|"     A clinical randomized trial to evaluate if CF guided Radio Frequency Ablation (RFA) to a     specific of LSI in atrial flutter i superior to standard RFA.   "
28130|NCT02917525|"     Early development of calcified aortic valve disease (CAVD) is a commonly occurring     complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two     leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the     aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may     lead to necessity of valve replacement, since to date, no other therapies have been shown     effective in the treatment of CAVD.      The primary objective of our study is to test the hypothesis that supplementation of vitamin     K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation     of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of     calcification.      In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2     or placebo group. To assess the calcification process in a detailed manner in these patients,     a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has     been shown to bind to regions of newly developing microcalcification in aortic valve tissue     is used.      We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic     valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium     score on CT and echocardiography after 18 months (secondary endpoints), when compared to     placebo.   "
28131|NCT02917512|"     A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II     Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with     Dry Eye Syndrome   "
28132|NCT02917499|"     The goal of this study is to examine the efficacy and safety of transcranial magnetic     stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological     disorders. Subjects will be randomized into two groups: experimental (treated with     pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and     their clinicians will complete a battery of instruments that measure relevant symptoms,     global functioning and quality of life. The first measurement will be done after the     inclusion and before treatment. The second measurement will be made immediately after the end     of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6     months.   "
28133|NCT02917486|"     The objective of the study is to investigate the exposure difference between antibiotic     studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients     without Extracorporeal Membrane Oxygenation.      The exhibition is evaluated by population pharmacokinetic modeling.   "
28304|NCT02915211|"     To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years     and over, with intractable epilepsy or Glut-1 DS on a KD.   "
28134|NCT02917473|"     First-degree relatives of patients with melanoma have a greater risk of developing melanoma.     Patients are advised orally to inform their first-degree relatives that they should protect     their skin from UV radiation and ask for a skin examination from a general practitioner or     dermatologist. The study will evaluate the effectiveness of a written sheet in addition to     the usual oral counselling to increase acceptance of skin examination by the first-degree     relatives. If effective, written counselling provided to the patient for relatives should be     recommended and generalized.   "
28135|NCT02917460|"     Rady Children's Institute for Genomic Medicine (RCI) will collect biological samples (such as     blood), derived genomic sequences (from DNA and RNA), and clinical features in a     Biorepository as a standardized resource for future research studies. The purpose of the     Genomic Institute Biorepository is to provide consented samples and data for basic and     clinical research related to the genomic cause and treatment of childhood disease, and, in     the future, as reference (Quality Control) data to improve the ability to make clinical     diagnoses or clinical decisions.      In addition, the Biorepository will provide a mechanism for making a diagnosis of a genetic     disease. That is, once genomic sequences have been derived from biological samples, they will     be immediately analyzed. If a genetic disease is identified that appears to explain an     affected child's clinical features, then those results will be confirmed by the medically     accepted standard, and placed in the electronic health record.   "
28136|NCT02917447|"     The purpose of this study is to evaluate an online PTSD intervention that was adapted for     women Veterans, called DElivery of Self TRaining and Education for Stressful Situations-Women     Veterans version (DESTRESS-WV). The intervention consists of structured online sessions as     well as weekly brief phone calls for additional support with a study coach. Women Veterans     with PTSD who are eligible will be randomized to receive either DESTRESS-WV or phone     monitoring only for 8 weeks. Participants will be assessed immediately post-treatment as well     as at 12 and 24 weeks post-treatment. Investigators hypothesize that participants randomly     assigned to DESTRESS-WV will have a greater decrease in severity of PTSD symptoms compared to     those randomly assigned to phone monitoring only.   "
28137|NCT02917434|"     The study is an open intervention study with the aim to determine the effects of weight-loss     treatment with Low-Energy liquid Diet (LED) on disease activity, quality of life and markers     of the metabolic syndrome in patients with psoriatic arthritis and obesity.   "
28138|NCT02917421|"     This protocol is for patients with newly diagnosed breast cancer with an indication for     post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.   "
28139|NCT02917408|"     Retrospective study of all patients diagnosed with primary biliary cholangitis during January     2001 to July 2016 at West China Hospital by review of medical records. The following     variables will be retrospectively studied: age, sex, first symptoms, clinical     characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune     diseases and long-term outcome.   "
28141|NCT02917382|"     Liver transplantation (LTx) is the standard treatment used in the final stage of chronic or     acute liver failure. The success for the LT depends on many factors. One of the factors     related to morbidity and mortality of these patients is malnutrition. Patients on the waiting     list for LTx are increased risk of malnutrition and metabolic disorders that may be     associated with decreased functional capacity, change in resting energy expenditure cardiac     autonomic dysfunction. These conditions may influence the results both before and after     transplantation, as the clinical outcome and complications present in the postoperative     period. Therefore, this study aims to characterize and relate nutritional status, metabolic,     functional and clinical outcomes in the recent postoperative patients undergoing liver     transplantation. It is an observational, prospective study based on four evaluations: the     first will be conducted while the patient is awaiting transplantation; and after insertion of     the graft, patients will be evaluated between the 1nd and 3th postoperative day, between 5     and 7 days and at discharge from hospital.      In the late post-transplant, there is the action of immunosuppressive drugs, largely     responsible for increased survival, but also on the other hand, are responsible for important     nutritional and metabolic disorders. Metabolic complications such as hyperkalemia,     hypertension, diabetes mellitus and overweight have been described. Thus, due to the high     incidence of these complications, alternative options, such as lowering the dose of     immunosuppressive drugs, have been fully explored, particularly as regards association with     the viability of the graft. However, few studies have evaluated whether there is change in     the incidence of metabolic disorders, cited above, in relation to the different doses of     immunosuppressive drugs. Furthermore these metabolic complications will be evaluated in the     late post-transplant period.   "
28142|NCT02917369|"     Integrative analysis of LCLC   "
28143|NCT02917356|"     Osteoarthritis (OA) is the most common form of chronic degenerative joint disease, as well as     the main cause of pain and disability in older persons worldwide. The limited results of     physical therapy in OA makes OA patients potential candidates for complementary therapies,     such as laying on of hands. The present study aims to investigate the effect of Laying on of     Hands on the Pain, Joint Stiffness and Functional Capacity of Elderly Women With Knee     Osteoarthritis. This is a randomized controlled trial with three allocation groups: spiritual     laying on of hands (passe espiríta - Spiritist passe/spiritual healing) (SP), non-spiritual     laying on of hands (LH) and Control Group without laying on of hands (CG). All subjects will     participate in a 45-minute kinesiotherapy program. After that, groups will be directed to the     5-minute session of laying on of hands according to their groups. During the application of     SP, LH and CG, the subjects will remain in a sitting position, blindfolded with dark goggles,     and receive the following verbal command: Relax and calm your mind. The intervention will     happen twice a week for eight weeks and a blinded physical therapist will assess the pre and     post scores of pain, functionality, joint stiffness (through WOMAC and visual analogic     scale), anxiety and depression (HADS), religiosity (DUREL) and spirituality (FACIT Sp12) and     quality of life (WHOQOL-Bref), among other secondary outcomes.   "
28144|NCT02917343|"     The purpose of the study is to determine the effect of a combined mirror therapy and task     oriented/repetitive task training on upper extremity function of persons with hemiplegia due     to cerebrovascular accident or stroke.   "
28145|NCT02917330|"     The purpose of this randomized and controlled intervention study is to explore the effect of     a physiotherapy intervention targeting contract and spastic hamstring muscles in children     having bilateral spastic cerebral palsy (CP), GMFCS I-III: A stretching routine targeting     hamstrings (and psoas if short), and a progressive strengthening program on the muscles     extending then lower extremities (quadriceps, gluteus maximus and triceps surae)      Study hypothesis: Stretching of hamstrings and strength training of the extending muscles in     the lower extremities in children with bilateral spastic cerebral palsy will increase     popliteal angle, active knee extension, and gait function.   "
28146|NCT02917317|"     To investigate biomarkers in prediction of cardiometabolic and other diseases of adults aged     20-60 years.   "
28148|NCT02917291|"     The main objective of the study is the evaluation of the safety and tolerability of FAB117-HC     (a medicinal product containing human allogeneic adipose derived adult mesenchymal stem cells     expanded and pulsed with H2O2, HC016 cells) administered at a single-time point to patients     with acute thoracic traumatic spinal cord injury (SCI). The study will also include initial     exploration of potential clinical efficacy. Dose levels of 20 million and 40 million cells     will be administered.   "
28149|NCT02917278|"     This pilot study aims to produce preliminary data on the safety of providing high-protein     meals to patients during dialysis, and effects of this intervention on nutritional status and     quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will     follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of     daily recommended protein intake. Patients will be allocated to either the treatment or     control group by HD shift schedule. 2 months of baseline data will be collected, followed by     9 weeks of meal intervention/control and data collection. The primary outcome will be     frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes     will include highest and lowest systolic blood pressure during dialysis, blood biochemistries     including measures of renal function, nutritional status, and electrolyte balance; dialysis     compliance; fluid retention; sleep and other quality of life measures; and dietary intake     data.   "
28150|NCT02916667|"     Working hypothesis and aims:      To asses Chrono Biological factors during the third trimester of gestational diabetes     melittus (GDM) with birth weight and related complications. The investigators hypothesize     that participants with GDM pregnancies with higher Chrono Biologocal status will be ended     with higher birth weight compared to participants with GDM pregnancies with lower status. In     addition, the investigators hypothesize that the Chrono Nutritional intervention program will     contribute to the reduction of the rate of birth weight above percentile 90 compared with the     participants with GDM in the control group.   "
28151|NCT02916654|"     Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a     phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which     shows a high gastrointestinal absorption and high bioavailability with a low incidence of     side effects due to lack of any direct contact with intestinal mucosa. In comparison with the     other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy     of iron replacement in CD patients.   "
28152|NCT02917252|"     This study evaluate the metabolic effects of orally ingested ketone bodies. The study is     conducted as a randomized, cross over study.   "
28192|NCT02916706|"     This study is designed as a prospective, multi-centre, parallel group, double-blind     randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of     MP-513 (Teneligliptin).   "
28154|NCT02917226|"     The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web     and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases     screening, diagnosis, treatment and monitoring for the use of physicians and patients in     primary care and to determine the effectiveness of the system. For validating the CDSMS for     diabetes patients, randomized controlled trial will be conducted.A parallel single blind     randomized controlled trial will be implemented. 10 physicians and their 439 patients are     involved in the study. According to the results of screening which is done using developed     CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the     physicians. The recruited patients will register to the CDSMS with their accounts given by     their physicians. Eligible participants will be assigned to intervention and control groups     with simple randomization. The significance level will be accepted as p<0,05. In the     intervention group, the system recommendations on diagnosis, treatment and monitoring will be     carried out as the final decision given by the physician. In the control group, physicians     will treat DM patients as the general routine. Patients in both groups will be monitored for     6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory     outcomes will be face-to-face assessed, others will be online self-assessed.   "
28155|NCT02917213|"     This project aims to assess the ability of cardiac imaging (cardiac MRI and     Doppler-echocardiography) post-processing tools to predict a combined end-point of     intraventricular thrombosis, silent brain infarcts, clinical stroke and peripheral arterial     embolism in patients with first acute myocardial infarction and ventricular dysfunction.   "
28156|NCT02917200|"     The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and     effective for capturing fecal residues of moxifloxacin in healthy volunteers.   "
28157|NCT02917187|"     The primary objective of the study is to investigate the efficacy of repeat oral dosing of     BIIB074 on paroxysmal pain in participants with Primary Inherited Erythromelalgia (EM). The     secondary objective of the study is to investigate the efficacy of repeat oral dosing of     BIIB074 on varying additional aspects of pain in participants with EM; and to investigate the     safety and tolerability of repeat oral dosing of BIIB074 in participants with EM.   "
28158|NCT02917174|"     Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation,     which is a common and frequently occurring disease in the world, and has resulted in a     sustained increase of social and economic burden. However, several studies suggest, lots of     asthma patients did not get their asthma controlled. The investigators study showed that in     China only 28.7% of asthma patients achieve asthma controlled during 2007-2008. In recent     years, application softwares of mobile-phones for asthma have gradually increased, studies     suggested that application of these application softwares can make treatment more standard,     reduce asthma attacks, help patients to control their asthma, improve adherence and these     application softwares also show many other advantages. This study is a prospective, multi     center, randomized, controlled study, aims to evaluate the efficacy of application softwares     in asthma patients, provide a new tool to asthma management.   "
28159|NCT02917161|"     MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis     of the prostate after this intervention. Thus, PAE might also play a role in the treatment of     prostate cancer.      This proof of concept study assess the impact of PAE in patients with proven prostate cancer.   "
28160|NCT02917148|"     The goal of this research proposal is to identify a miRNA expression profile as a biomarker     to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo     allogeneic transplantation. This biomarker, once identified, will need validation in larger     cohorts.   "
28162|NCT02917122|"     Parkinson's disease (PD) is one of the most common neurological diseases manifested by     movement disturbance. The concomitant psychiatric symptoms, especially depression, are often     observed and have also great impact on patients' quality of life. The treatment of depressive     symptoms in PD with antidepressants as the majority remains variable and inefficient, which     complicates the disease prognosis. Transcranial direct current stimulation (tDCS) is a     non-invasive brain modulation technique and has been demonstrated to improve psychiatric     diseases such as major depression. In this study the investigators will assess the combined     effects of tDCS on sertraline for the treatment of depression in PD. Ten sessions of tDCS in     two weeks will be applied and the follow-up evaluation will continue bi-weekly for one month     after completing all sessions. The efficacy of tDCS vs sertraline will be compared and     evaluated with behavioral and cognitive outcome. In addition, the investigators will evaluate     if the baseline dopaminergic activity in brain could predict the treatment outcome by using     SPECT imaging. The investigators aim to establish the therapeutic parameters and safety     criteria of tDCS as an add-on or alternative therapy, and further enhance the overall     clinical efficacy in the treatment of depression in PD.   "
28163|NCT02917109|"     The purpose of this investigation is to conduct a series of case studies on the impact of     LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for     participants with ADHD.   "
28164|NCT02917096|"     This pilot clinical trial studies the side effects and best dose of ruxolitinib phosphate     when given together with chemotherapy before and after a donor stem cell transplant in     treating patients with myelofibrosis. Ruxolitinib phosphate may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as fludarabine phosphate and melphalan, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving ruxolitinib phosphate together with chemotherapy before and after     a donor stem cell transplant may help stop the growth of cells in the bone marrow, including     normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. The donated stem cells may also replace the     patient's immune cells and help destroy any remaining cancer cells.   "
28165|NCT02917083|"     The subject has a type of lymph gland cancer called Lymphoma.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancer. This research study combines two different ways of fighting disease:     antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting     blood cells that can kill other cells, including tumor cells or cells that are infected with     germs. Both antibodies and T cells have been used to treat patients with cancers; they both     have shown promise, but have not been strong enough to cure most patients. Investigators hope     that both will work better together.      Investigators have found from previous research that they can put a new gene into T cells     that will make them recognize cancer cells and kill them. They now want to test whether these     genetically modified T cells given after chemotherapy will be more effective at killing     cancer cells.      The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody     sticks to lymphoma cells because of a substance on the outside of the cells called CD30.     Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong     enough to cure most patients.      For this study, the anti-CD30 antibody has been changed so that instead of floating free in     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way     it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells (CD30.CAR T     cells) seem to kill some of the tumor, but they don't last very long and so their chances of     fighting the cancer are unknown.      Several studies suggest that the infused T cells need room to be able to multiply and grow to     accomplish their functions, and that this may not happen if there are too many other T cells     in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of     circulating T cells prior to the CD30.CAR T cells infusion. This is called lymphodepletion.      CD30.CAR T cells have previously been studied in lymphoma patients. What is new for this     study is that lymphodepletion chemotherapy will be administered in patients who are not post     autologous transplant in the hope that it will result in more durable anti-tumor effects.   "
28166|NCT02917070|"     Inbreeding and consanguineous marriages are known to increase the risk of autosomal recessive     disorders. The aim of this study was to examine the association between consanguinity and     kidney diseases in the adult Turkish population.   "
28167|NCT02917057|"     Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment     of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves     glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as     necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages,     such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid     profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes     in customary clinical care in patients with mild and moderate renal impairment and in elderly     patients are unknown.      The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative     to basal insulin initiated as first-ever injectable therapeutic regimens among elderly     patients and patients with renal impairment. Patients who initiated treatment with Bydureon     or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts     from Optum's database of electronic health records. The two treatment cohorts will be matched     by propensity score method. Changes in HbA1c, weight, markers for renal function (estimated     glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and     incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with     different eGFR categories and with different ages.   "
28168|NCT02917044|"     This is a prospective, multicentre, randomized single blind, parallel group study to be     conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40     eligible for randomization. The study is designed to compare the operator's best attempt at     WACA completion with and without Rhythmia guidance   "
28169|NCT02917031|"     This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled     study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and     function in patients with type 2 diabetes (T2DM) mellitus and heart failure (HF).   "
28189|NCT02916745|"     This research study is being conducted to assess the safety and feasibility of using a new     developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects     with solid tumor in peripheral lung, who are inoperable or refused surgery, and are not     candidates or refused radiation therapy. It will involve 10 sites in USA and Canada.     Participation will last 6 months.   "
28228|NCT02916199|"     The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an     initial procedure for biliary access in patients with common bile duct stones who are at     increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography     (PEP) and to assess the incidence rate of complications including PEP between NKF and     conventional cannulation methods.   "
28170|NCT02917018|"     Emergence agitation is a post-anesthetic phenomenon that develops in the early phase of     general anesthesia recovery, and is characterized by agitation, confusion, disorientation,     and possible violent behavior. The incidence of emergence agitation is less common in adults     as compared to pediatric patients. It may lead to serious consequences for the patient such     as bleeding, falling, removal of catheters and self extubation, which lead to further     complications like hypoxia and aspiration.      Despite its common occurrence, unclear etiology, and serious sequelae, emergence agitation     has rarely been studied in adults.      The stress response to surgery is an unconscious response to tissue injury. Activation of the     sympathetic nervous system, increase of catabolic hormone release and pituitary gland     suppression are considered a response to surgical stress, in clinical practice these     activities cause changes in heart rate, blood pressure and biochemical fluctuations of     noradrenaline, adrenaline, dopamine, and cortisol. Above all, these fluctuations prolong     hospitalization and delay patients discharge.      Dexmedetomidine is a highly selective alpha-2 receptor agonist having sedative, analgesic and     sympatholytic properties. Decreased stress response to surgery ensuring a stable hemodynamic     state is a beneficial property of the agent. Peri-operative use of dexmedetomidine also     decreases postoperative opioid consumption, pain intensity, and antiemetic therapy. However,     the data related to the effects of dexmedetomidine on reducing agitation from general     anesthesia in adults are limited.   "
28171|NCT02917005|"     This is an open label, randomized, multicenter, international phase II study for     premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally     advanced breast cancer. Patients will be randomized to receive either palbociclib +     exemestane + OFS (Arm 1) or exemestane +OFS (Arm 2).      Treatment will be continued until disease progression, unacceptable toxicities, or withdrawal     of consent.   "
28172|NCT02916992|"     To assess the prevalence of BHD (Birt-Hogg-Dubé syndrome) among patients with spontaneous     pneumothorax. Patients who were treated for primary spontaneous pneumothorax in Rijnstate     hospital are to be included. Patients will receive a questionnaire. When given consent, the     investigators will invite them for a one-time visit to the out-patient clinic. Patients will     be asked for a blood sample to determine pathogenic FLCN (folliculin) mutations and a     pulmonary CT scan for evaluation of presence of lung cysts.   "
28193|NCT02916693|"     The only class of oral erectile dysfunction (ED) medication on the market are the     phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the     effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder     (OAB) symptoms and mild to moderate ED.   "
28194|NCT02916680|"     The overall objective is to establish that transplantation of allogeneic pancreatic islet     cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and     does not cause ophthalmic or systemic complications. Furthermore, the change in insulin     production, glucose control and hypoglycaemia awareness will be assessed.   "
28173|NCT02916979|"     This study is examining a chemotherapy regimen and immune suppressive medications in the     setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the     incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune     checkpoint regulators (V-domain Ig Suppressor of T-cell Activation [VISTA], cytotoxic     T-lymphocyte- associated protein 4 [CTLA-4], programmed death-ligand 1 [PD-L1]) during early     immune recovery following an allogeneic stem cell transplant. The site will use a     myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define     clinical endpoints, including engraftment, 100 day survival and one year survival (Objective     #1). The site will characterize the incidence, prevalence and function of MDSCs and immune     checkpoint regulators in patients' blood and bone marrow following transplantation (Objective     #2). The site will correlate these laboratory results with clinical outcomes and the     incidence of graft-versus-host disease (GVHD). As an exploratory aim, in those patients     experiencing GVHD and requiring treatment, the site will define the MDSCs frequency and     checkpoint regulator expression and correlate these results with the patient's response to     GVHD therapy.   "
28174|NCT02916966|"     The proposed research is particularly relevant to the National ALS Registry and public     environmental health issues because it addresses the potential environmental causes of     sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be     compared with the national and State-Metro Surveillance Programs of the National ALS     Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA,     and other environmental toxicants as risk factors for ALS. This work will advance the mission     of the CDC ATSDR National ALS Registry by offering data on ALS cases in Ohio that address     public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake     Erie.   "
28175|NCT02916940|"     There is currently no real consensus on the optimal management of acute sprains of the     proximal interphalangeal joint of the long fingers.      The aim of this study is to assess the beneficial effect of an injection of corticosteroids     for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute     phase). This treatment, if effective, might become the treatment of choice for these types of     injuries, instead of a prolonged immobilization or a careful early mobilization.   "
28176|NCT02916927|"     Objective: The purpose of this study is to determine if administering ketamine as an     intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse     drug reactions without attenuating its analgesic effects.      Study design: prospective, randomized, controlled, double-blind trial.   "
28177|NCT02916914|"     Preterms are usually fed with intervals of either two or three hours during their stay in     neonatal intensive care unit. Recommendations of World Health Organization about feeding     regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are     not proposed with regards to results of randomized controlled trials. Investigators aimed to     investigate the impact of 2-hourly feeding on time of transition from orogastric to oral     feeding.   "
28178|NCT02916901|"     The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood     pressure after oral administration in healthy adult volunteers.   "
28179|NCT02916888|"     The purpose of this study is to investigate the differences in the quality of life of     patients and caregivers who are treated by general pediatricians versus pediatric     dermatologists for eczema (atopic dermatitis or AD).   "
28180|NCT02916875|"     In 2015 the Danish healthcare authorities initiated major changes in the follow-up (FU)     program for patients with ovarian cancer. The new FU program argues that there is no effect     of routine monitoring, and every patient's FU is now individualized. These changes have     caused major concern, especially regarding the omission of routine examinations aimed at     detection of recurrence, since clinical symptoms of relapse can be diffuse. Clearly, tools     and FU plans to support the patients in feeling safe during FU are of vital importance.      Patient-reported outcome measures (PROM) is a tool to improve the focus on patients' needs,     symptoms and preferences. It is also a tool to monitor quality of life (QoL), and side     effects.      300 patients with ovarian cancer are planned to be enrolled after primary treatment when they     enter follow-up program. This is a multi-center study.      All participants fill in a questionnaire at baseline and then every 3 months for two years,     and every 6 months the third year. The questionnaire consists of EORTC-QLQ-C30, EORTC-OV28,     and questions on symptoms of relapse. At baseline the questionnaire is extended with     demographic issues.      The patients will also fill in a brief questionnaire (CollaboRATE) dealing with patient     satisfaction and the level of shared decision making experienced.      All participants are followed for 3 years.   "
28181|NCT02916862|"     The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF)     supplementation for 1 year on bone metabolism in growing adolescents compared to controls.     For the proposed study, a randomized double-blinded placebo controlled clinical trial will be     conducted in 168 healthy adolescents aged 11-14 years, equally randomly assigned to one of     three intervention groups: SCF (12 g/d, administered twice a day), SCF + calcium (12 g/d of     SCF + 600 mg/d of elemental calcium carbonate, twice a day), or placebo (0 g/d of SCF or     calcium, administered twice a day). Bone metabolism and bone related biomarkers will be     assessed at baseline and at 12 months.   "
28195|NCT02916641|"     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European     drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in patients with PBC improves     serum liver biochemistries and survival free of liver transplantation However, about 40% of     patients do not respond to UDCA optimally as assessed by known criteria for biochemical     response. Those patients represent the group in need for additional therapies, having     increased risk of disease progression and decreased survival free of liver transplantation.     And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might     jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis     and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could     significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here we     start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu     combined with UDCA in the PBC treatment.   "
28431|NCT02913521|"     A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study     to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech     Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in     Patients With Osteoarthritis of the Knee   "
28182|NCT02916849|"     This five arm feasibility study aims to promote self-management in strength and balance     exercises among community-living older people. The research process, implementation     strategies and procedures, acceptability of the exercise programs, perceived benefits of the     programs, and the ecological validity, acceptability and ability to detect change of possible     outcome measurements will be evaluated before a future randomized controlled trial. A     comparison of two exercise programs will be performed; a) Safe Step, a mobile technology     based exercise program with motivational strategies, developed by researchers in     collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises     presented in a booklet. The older participants will be free to select either of the     intervention programs and the selection process and outcome will be studied as part of the     process evaluation.      The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be     recruited through advertisements in local papers and through posters and meetings at senior     citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants     will be recruited from health care centres and their registered professionals with experience     of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at least 10     participants in each, will be exercising for four months and will undergo testing at     baseline, after two and four months and they will be asked to keep an exercise diary (digital     or paper format) during the intervention.   "
28183|NCT02916836|"     The drug iatrogenesis represents an important public health problem. In the Iatromed project,     we want to to assess a specific therapeutic drug conciliation sheet (TDC). This multicenter     observational study is focus on 750 patients aged over 75 year old with polymedication. The     main objective will be to determine if the use of the TDC, at the discharge of hospital,     allows to reduce the number of use in emergency care within the two month after their     hospital discharge   "
28184|NCT02916810|"     Major psychotic symptoms such as auditory hallucination (AH) are main features of     schizophrenia and other psychotic disorders, resulting in severe social and clinical     dysfunction. However, these symptoms are sufficiently unresponsive to antipsychotic     medications in a substantial portion of patients. Neuroimaging studies suggest that aberrant     activities at specific brain regions such as frontal areas, sensory areas and     language-related areas are related to these symptoms. Transcranial magnetic stimulation (TMS)     provides a non-invasive means for altering brain electrical neural activity. TMS has been     used in a wide range of clinical research especially in neurology and psychiatry. There are     preliminary treatments of psychosis and AH using TMS but results are inconsistent. The high     inter-subject variability limits the efficacy of TMS treatment for schizophrenia patients.     The investigators aim to develop a TMS treatment method with a functional MRI-defined     treatment target area, where the TMS target is individually identified to maximize the TMS     effects. If the current target-identification successfully identified effective TMS target     individually, the treatment efficacy could be significant improved and more patients will     benefit from TMS treatment.   "
28185|NCT02916797|"     -  Are there differences in immediate effects of stepping training with and without the use          of visually weight-taking machine (VWTM) on variables relating to well-controlled          walking and walking symmetry in ambulatory patients with stroke?        -  Are there differences of 4-week stepping training with and without the use of VWTM on          variables relating to well-controlled walking and walking symmetry in ambulatory          patients with stroke?   "
28190|NCT02916732|"     The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the     Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical     data for the evaluation of potential complications due to having ZIKV infection during     pregnancy. This study is meant to collect, within usual care practices, clinical and     paraclinical information which will allow the precise description of the consequences of ZIKV     infection occurring during pregnancy.   "
28191|NCT02916719|"     Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the     loco-regional staging and direct the treatment.      European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement     of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care     consists of realizing a MRI before the start of the NAC and another one after it's ended, six     months later.      There is currently no consensus on the realization of an interval MRI for early assessment of     the chemosensitivity of the tumor. It would allow though alterations in the therapeutic     regimen in the event of a non response. Similarly, there is no consensus on when this     interval MRI should be performed.      Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting     for the evaluation of the early response. However, these are preliminary studies with     quantitative measures realized by the region of interest (ROI) method. A response to     neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC).      There is'nt any published data on the potential interest of breast MRI after a radiotherapy     treatment and before the surgical treatment.      Therefore, the expected benefits of this study are:        -  to monitor the early modifications of the perfusion and diffusion parameters at the          level of the tumor after radiotherapy, and correlate them to the histology of the          surgical monster.        -  to assess if MRI is able to objectivate the early signs of response after a radiotherapy          neo-adjuvant treatment of breast cancer.      This record is linked to the NCT02858934 record and will share the same cohort of patients   "
28196|NCT02916628|"     Objective The purpose of this study is to examine the effects of auricular acupressure and     group counseling with positive psychology and motivational interviewing on smoking cessation     and tobacco withdrawal symptoms.      Methods This study is a single blind randomized controlled trial. This study has been     performed at a University in South Korea. 180 smokers and 60 non-smokers will be recruited.     Smokers will be randomly assigned to three groups: group 1 (auricular acupressure + group     counseling); group 2 (placebo acupressure + group counseling); and the control group     (self-help smoking cessation). Group counseling is undertaken once per week for 6 weeks.     Auricular acupressure using acupellets is performed for 6 weeks continuously.   "
28197|NCT02916615|"     The purpose of this study is to examine the effect of different vegetables on cardiovascular     function in subjects with moderately increased blood pressure. Specifically we are comparing     the effects of vegetables with a high natural content of inorganic nitrate with those of     vegetables with a low nitrate content.   "
28198|NCT02916602|"     A phase 3 study to evaluate efficacy and safety of HCP1401   "
28199|NCT02916589|"     Obesity continues to pose major public health challenges worldwide with cardiovascular     damage, hypertension and diabetes as possible subsequent conditions. The obese are at risk     for mortality and morbidity as they suffer from a high level of immune sensitivity with     consequences related to damage to the circulation and microvasculature. The immune process     itself is modulated by cytokines, which are small proteins which can modulate the spectrum of     the inflammatory process. These proteins may act as biomarkers in the mouth.      Diabetes is also a consequence of sustained obesity and this condition can strongly influence     immune status. Diabetes is characterized by the failure to produce the hormone insulin or a     loss of sensitivity to insulin. Without insulin high blood glucose results in the release of     a series of pro-inflammatory factors, which lead to pathological processes in several organs     leading to high mortality and morbidity. Periodontitis, a common complication of diabetes, is     an inflammatory condition of the soft tissue of the periodontium, causing alveolar bone loss.     The accessibility of the oral cavity facilitates the study of early inflammatory processes.      Changes in diet may reduce inflammation, controlling gingival inflammation as well as     clinical treatment. Since 2004 Igelösa Life Science AB has developed a modified Nordic diet     based on evidence, primarily from the Japanese island of Okinawa, where the world's oldest     and most healthy people live. In this study we will investigate the association between     Igelösa dietary intake and measurements of inflammation in 30 overweight individuals with or     without other systemic diseases.   "
28200|NCT02916576|"     The user performance evaluation shows whether people with diabetes are able to obtain     accurate measurement results with a blood glucose monitoring system. In this study, user     performance evaluation will be performed for Contour Plus One (Ascensia Diabetes Care GmbH),     Accu-Chek Performa Connect (Roche Diabetes Care GmbH), FreeStyle Optium Neo (Abbott Diabetes     Care Inc.), OneTouch Select Plus (LifeScan Europe) based on ISO 15197:2013; EN ISO     15197:2015, clause 8.      For each BGMS, measurement procedures for user performance evaluation will be performed with     1 test meter and 1 reagent system lot by the study subjects.      The same meter and an additional test meter will be used for double measurements performed by     study personnel (with the same reagent system lot used by subjects).   "
28201|NCT02916550|"     This study examines the impact of a breathing training intervention on cardiorespiratory     sensations and anxiety in adults with cardiac arrhythmias.   "
28202|NCT02916537|"     The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET)     imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane     Antigen (PSMA) and is designed to detect prostate tumors.   "
28203|NCT02916524|"     The purpose of this investigation is to implement a computational model that can predict and     optimize training and cross-language generalization patterns for bilingual persons with     aphasia (BPA). The proposed work will determine the best possible treatment program for each     individual patient even before they are rehabilitated. In addition, the computational model     allows specification of variables such as age of acquisition, language exposure/proficiency,     impairment and their systematic influence on a range of language rehabilitation outcomes.   "
28204|NCT02916511|"     The purpose of this study is to evaluate safety and 2-year local control rate for extensive     clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for     esophageal squamous cell carcinoma.   "
28207|NCT02916472|"     Only a few clinical trials evaluating the potential benefits of exercise have been conducted     in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the     potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer     survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility     (adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise     program on fitness, body composition, quality of life, sleep and cognition.   "
28208|NCT02916459|"     This is a prospective randomised diagnostic clinical study to determine whether the use of a     new flexible sampling needle can improve the yield of endobronchial ultrasound guided     transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical     reasons as deemed necessary by the managing physician or multidisciplinary team will be     randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed     under local anaesthesia using conscious sedation or general anaesthesia according to usual     practice at the trial centre. Specimens will be placed in saline and formalin and forwarded     to the pathology laboratory. The specimens will be spun down to create a cell pellet which     will undergo cytological and histological examination as per usual protocol at the trial     centre.The pathologist, who will be blinded as to which technique was used to obtain the     sample, will grade the quality, quantity, and cellularity of the specimens.   "
28432|NCT02913508|"     The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of     multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).   "
28210|NCT02916433|"     This study is an open-label, randomized controlled trial. Patients will be randomized into     two groups of 15, Routine Care group, which will serve as the control group, and     Octreotide group. The amount of bronchial secretions is routinely measured in all     mechanically ventilated patients. Once the Primary Team identifies a patient as a candidate     for the study (based on the inclusion and exclusion criteria) and an informed consent has     been obtained, the baseline volume of bronchial secretions per 12-hour period will be     recorded and a security envelope containing group assignment will be opened by the ICU     attending. Both groups will continue to receive treatments that have already been initiated     to manage bronchial secretions. In addition, Octreotide group will receive parenteral     octreotide, while Routine Care group will receive care as deemed necessary by the Primary     Team. The rate of bronchial secretions will be measured and recorded daily; the changes,     relative to the baseline measurements, will be compared between the groups. These     interventions will be continued for 72 hours or until extubation or withdrawal from the     study, whichever occurs earlier. Subsequently, the standard of care management, as determined     by the Primary Team, will be resumed.   "
28211|NCT02916420|"     This study aims to assess the efficacy and safety of pomalidomide in combination with     low-dose dexamethasone in Chinese patients with relapsed and refractory multiple myeloma.   "
28212|NCT02916407|"     The investigators evaluate extubation time and recovery profiles in children undergoing     entropion surgery.   "
28213|NCT02916394|"     The investigators developed [68Ga]-labelling Anti-IGF-1R Affibody Molecule as a targeted     molecular imaging agent for noninvasive and repeatable detecting IGF-1R expression status.   "
28214|NCT02916381|"     Unilateral mastectomy is associated with moderate to severe postoperative pain. A new     regional anaesthetic technique has been recently described, call the PEC block. This     technique consists of injecting local anaesthetic between different muscles of the chest in     order to relieve postoperative pain. The investigators aim to verify that this technique has     a clinical relevant postoperative analgesic effect. For that purpose, the investigators will     randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group     will receive a PEC block after the induction of the general anaesthesia under ultrasound     guidance, while the other group will not have this regional procedure.   "
28215|NCT02916368|"     Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck     malignant tumors .Investigators found that several patients with early TNM stage and poor     differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well     differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis     factors and survival rates probably related to the differentiation of HNSCC, and prognosis     factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the     prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.   "
28216|NCT02916355|"     Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single     dose, placebo-controlled, double blind, cross-over, proof-of-concept study.      16 healthy young men will be included in this study. The objective of this study is to     evaluate if severity of postprandial fatigue is driven by IL-1.      Since fatigue is associated with increased cytokine levels, and since fatigue in chronic     inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β,     postprandial fatigue might also respond to anti-inflammatory intervention with IL-1     inhibition.      The aim of the study is to investigate whether postprandial fatigue is, at least in part,     driven by the IL-1 system.   "
28225|NCT02916238|"     Depression is often the most prevalent mental health problem among people living with HIV     (PLWH) worldwide, and if not adequately treated, it may impair response to antiretroviral     treatment (ART) and the ability of individuals to adhere to medications and healthy behavior.     Most patients with depression receiving ART in the poorest countries of the world are left     untreated because no systematic approach or expertise is available. This study adapts an     evidence-based model of depression care (Measurement-Based Care - MBC) using auxiliary HIV     clinic staff, and tests feasibility and assesses costs among HIV positive patients beginning     ART in Port-au-Prince, Haiti.   "
28226|NCT02916225|"     The purpose of this study is to determine whether high intensity interval training (HIIT) is     superior to moderate continuous training in increasing cardiopulmonary capacity in heart     failure with preserved ejection fraction patients.   "
28227|NCT02916212|"     This project aims to reduce the frequency of duplicate, false and clinically insignificant     alarms in hospital units, and subsequent alarm fatigue resulting from excessive alarm     frequency. The investigators will implement evidence-based guidelines for alarm optimization     according to patient-population specific parameters, and evaluate alarm frequency and staff     perception of alarm fatigue at baseline and 60 days after implementation of this quality     improvement initiative.   "
28217|NCT02916342|"     The interscalene block provides effective analgesia after shoulder surgery. It consists of     injecting local anaesthetic within the brachial plexus, in the interscalene groove, between     the anterior and middle scalene muscles. Unfortunately, this technique is associated with     respiratory complications such as hemidiaphragmatic paresis due to the spread of the local     anaesthetic towards the phrenic nerve that lies close to the brachial plexus, with an     incidence up to 100%. The diaphragmatic paresis may be a serious side-effect, especially in     patients suffering from a reduced respiratory function such as chronic obstructive pulmonary     disease; this entity may even represent a contraindication to the performance of the block.      The shoulder is mainly innervated by the suprascapular and axillary nerves, both of them     coming from C5 and C6 branches of the brachial plexus block. Recently, several authors have     successfully identified and block these two nerves under ultrasound guidance. Only one     randomised controlled trial compared interscalene block with a combination of suprascapular     and axillary nerve blocks, and showed inconclusive results probably due to the absence of     ultrasound guidance; indeed, analgesia was equivalent at the sixth postoperative hour, while     patients with an interscalene block had reduced pain scores in the recovery room. Besides,     the authors did not investigate the impact on the respiratory function.      In that randomised controlled trial, the investigators would like to compare the analgesic     efficacy and the respiratory outcomes between the interscalene block and the combined     suprascapular-axillary nerve blocks.   "
28218|NCT02916329|"     The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted     molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.   "
28219|NCT02916316|"     All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme     R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline     (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients     (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of     R-CHOP.   "
28244|NCT02915991|"     This is a prospective, single-arm, unblinded, case observation study evaluating a     commercially released 'Conformité Européenne' (CE)-mark co-registration software system     along-side of a commercially- released CE-mark coronary physiology and X-ray system during     routine clinical workflow. The purpose of this study is to collect Professional user feedback     regarding clinical utility of the SyncVision 4.X system.   "
28245|NCT02915978|"     The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual     Spray compared with placebo in participants with postoperative pain after a bunionectomy.   "
28246|NCT02915965|"     The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine     (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with     loco-regional esophageal squamous cell carcinoma (ESCC).   "
28220|NCT02916303|"     Schizophrenia has very significant economic consequences. Costs fall on many different parts     of society, especially on individuals with schizophrenia and their families. The first five     years after onset appears to be a critical period in which the symptoms are more responsive     to treatment. In addition, if left untreated for a long time, psychosis can impact many areas     of a person's life. The evidence base regarding the effectiveness of specialist early     intervention services for psychosis has grown steadily and evidence from randomized     controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority     of specialized early intervention programs over standard care on a broad range of outcomes     including symptomatic and vocational, social functioning, and reduced inpatient care and     treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the     cost-effectiveness of early intervention programs for first-episode psychosis is limited. The     provision of such services requires investment by health departments and services, and the     question of whether such services represent value for money has to date received little     research attention. Only a few international studies, and none conducted in Spain, have     investigated the cost effectiveness of early intervention in psychotic disorders at medium (3     years) and long-term (up to 10 years). In this study, the investigators aimed to analyse the     cost-effectiveness of an intensive early-intervention programme, using data from First     Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode     non-affective psychosis in Spain to date.   "
28221|NCT02916290|"     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European     drug administrations. Long-term use of UDCA (13—15 mg/kg/day) in patients with PBC improves     serum liver biochemistries and survival free of liver transplantation.      However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria     for biochemical response. Those patients represent the group in need for additional     therapies, having increased risk of disease progression and decreased survival free of liver     transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver     fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for     liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that     Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind     of etiology. Here the investigators start a random, open and parallel clinical research to     explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.   "
28222|NCT02916277|"     In this study; in patients undergoing mechanical ventilation, making the day series Endocan     measurements during the first 5 day to look at whether there is a relationship between the     levels of VAP with Endocan. This relationship, if any, aimed to investigate whether     correlated with clinical and laboratory findings [presence of fever, pathological lung X-ray,     the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)] .   "
28223|NCT02916264|"     It is a randomized control trial to compare the surgical plethysmographic index (SPI)     response during a Mayfield head-holder insertion in neurosurgical patients who receive a     scalp block versus those who do not receive the scalp block after induction of anesthesia     with propofol with fentanyl and intubation with cis-atracurium.   "
28224|NCT02916251|"     The trial is a single-centre, randomised, sequential, cross-over trial assessing     pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 (dasiglucagon*)     administered subcutaneously to patients with type 1 diabetes mellitus under euglycaemic and     hypoglycaemic conditions and compared to marketed glucagon.      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207   "
28230|NCT02916173|"     The follicular phase of the menstrual cycle involves the hourly release of     gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in     the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that     regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant follicle     and a small rise in progesterone lead to a gonadotrophic surge. An increase in the amplitude     of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte maturity and     triggers ovulation approximately   "
28247|NCT02915952|"     The study will evaluate the ZipLine Medical Surgical Skin Closure device (Zip)versus sutures     when utilized for skin layer closure during wound closure of Cesarean Section Procedure.   "
35096|NCT02826395|"     The investigators propose to conduct Carbon-11 Sodium Acetate PET/CT studies. The purpose of     our study is to evaluate the impact of Carbon-11 Sodium Acetate PET/CT studies on patient     management in patients with prostate cancer.   "
28231|NCT02916160|"     Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant     morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of     cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity     and mortality. To date, the CHF medical treatments have been reported to be inconsistently     efficient in the treatment of SAS.      SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level     B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF     trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In     comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation     for CHF by 20% with a 16% reduction in all-cause mortality.      The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF     patients presenting sleep apnea syndrome. A three months real life observational trial is     performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of     SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life     parameters is realized.   "
28232|NCT02916147|"     This study aim to observe and compare the change of alarmins such as high mobility group     nucleosome-binding protein-1 (HMGN1), high mobility group proteins b1 (HMGb1), Interleukin     (IL)-33 and their soluble receptors including soluble toll like receptor 4 (sTLR4) and     soluble ST2 (sST2) during pulmonary lobectomy for cancer patients receiving volatile     anesthesia or intravenous anesthesia under one-lung ventilation (OLV). By which, this study     will preliminarily evaluate the correlation of alarmins and prognosis as well as the effect     of inhalational and intravenous anesthesia on the prognosis of surgical patients.   "
28233|NCT02916134|"     This study aims to compare antibiotic treatment versus surgery for patients with     uncomplicated appendicitis.   "
28234|NCT02916121|"     The investigators study aims are:        1. To investigate folate, vitamin B12, and homocysteine levels in patients with          schizophrenia.        2. To evaluate the relationships among folate, vitamin B12, and homocysteine levels,          genetic variants of one-carbon cycle pathway, psychopathology, including positive          symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients with          schizophrenia.        3. For patients with low folate levels, the investigators would like to conduct a 24-week          double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d)          supplementation study to know whether combination of folic acid and vitamin B12 can          improve patients' psychopathology or metabolic profiles, and the effects of genetic          variants in one-carbon cycle pathway on treatment response.   "
28235|NCT02916108|"     Approximately 150,000 children present each year to emergency departments (EDs) in the US     with concussion and many more are treated by primary care physician, or outpatient     specialists.      Concussion is defined as a traumatically induced transient disturbance of brain function and     involves a complex pathophysiological process. There is a variety of symptoms related to     concussion, and the diagnosis of concussion requires the use of symptom-checklist. Since     there is a various degree of the severity of those symptoms, the diagnosis is a subjective     one and lacks sensitivity.      One major problem is that approximately one-third of the children with concussion experience     ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as     persistent post-concussion symptoms. A recent study that investigated the validity a 12-point     PPCS risk score revealed that it had modest validity (0.71). Moreover, one of the greatest     concerns is the child's schedule return to activity.      Since the basic mechanism for concussion is acceleration/ deceleration movement of axons, it     is likely to be expressed in desynchronization of delta wave activity between anterior     hemispheres as seen in pathological problems related to attention and/ or working memory).      The aim of this proof-of-concept study is to find-out whether interhemispheric     desynchronization of delta waves (IHDD) in the anterior hemispheres can identify acute     concussion in children. If the investigators find that IHDD can accurately diagnose acute     concussion, a second objective will be to examine whether this index can be a useful tool in     the follow up of patients with persistent post-concussion symptoms.   "
28236|NCT02916095|"     The purpose of this study is to evaluate the safety , tolerability, pharmacokinetics of     Kanitinib and determine the optimal dose in patients with recurrent or metastatic solid     tumors.   "
28237|NCT02916082|"     To evaluate the value of measuring cervical length as a predictor of vaginal birth after     induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.   "
28238|NCT02916069|"     Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies     during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce     costs after cardiac surgery with CPB.   "
28239|NCT02916056|"     This is an open-label extension study in patients with mild Alzheimer's disease who have     completed participation in the azeliragon Phase 3 (STEADFAST) trial. Patients will receive     azeliragon 5 mg/day for up to 2 years.   "
28240|NCT02916043|"     Cell-count related risk factors for acute kidney injury after cardiovascular surgery have     been reported. The authors attempted to investigate whether the perioperative cell counts of     neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury     and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.   "
28305|NCT02915198|"     This research will help us to learn if the medicine called metformin reduces the risk of     death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood     vessel problems.   "
28243|NCT02916004|"     The aim of the study was to describe the feasibility of the nociception flexion reflex and     the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit     (ICU). Furthermore to describe the relationship between the responses and the standard of     care pain evaluation in the critically ill sedated patients.      Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during     measurements in a stair-case increasing intensity model of standardized stimulations.     (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents     monitoring.)   "
28248|NCT02915939|"     Emerging research on family caregiving and institutionalization has emphasized that families     do not disengage from care responsibilities following a relative's admission to residential     long-term care settings. The Residential Care Transition Module (RCTM) provides 6 formal     sessions of consultation (one-to-one and family sessions) over a 4-month period to those     family caregivers who have admitted a cognitively impaired relative to a residential     long-term care setting (nursing home, assisted living memory care unit). The proposed mixed     method, randomized controlled trial will determine whether and how the RCTM decreases family     caregivers' emotional and psychological distress, placement-related strain, and increases     relative's transitions back to the community. The RCTM will fill an important clinical and     research gap by evaluating a psychosocial intervention designed for families following RLTC     placement to determine whether and how this approach can help families better navigate the     residential care transitions of relatives with Alzheimer's disease or a related dementia.   "
28249|NCT02915926|"     A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on     self-efficacy and occupational performance with mothers of children with cerebral palsy.     Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be     employed to data collection. The sample size was determined for each group of 15 people. The     participants conveniently and according to inclusion and exclusion criteria will be     randomized into the groups. Participants in the intervention group will be participated in 10     sessions of OPC. At the end the questionnaires will be completed by both groups.   "
28250|NCT02915913|"     The BrainFit Study aims to examine acute effects of High Intensity Interval- vs Resistance or     Combined program has benefits on Cognitive Function as well as on secretion and regulation of     neurotrophic factors or neurotrophins in a cohort of sedentary, overweight adults (aged 18-30     years) from Bogota, Colombia.   "
28251|NCT02915900|"     During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with     gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of     gonadotropin is important to avoid maturation of too few or too many follicles, which may     impair the chances of treatment success, lead to treatment cancellation, or serious side     effects.      Motivated by the lack of standardised procedures to estimate the optimal dosage of     gonadotropins, a patient-specific test has been developed to predict the optimal hormone     dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form     the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient     needs increased or reduced hormon doses.      In this clinical study the investigators compare deviation from optimal outcome at oocyte     pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes     collected in the group of patients matching the inclusion criteria of the study.      The control group receives starting hormone dosage assigned by the clinician according to     standard clinical procedures. The intervention group receives starting hormone dosage     adjusted according to the results of the Gonadotropin Removal Test.   "
28252|NCT02915887|"     Objective: This study examined the effects of elastic tape applied to the neck on patients     experiencing chronic neck pain.      Background: Neck pain is often persistent or recurrent. Various treatments have been     described, including exercises and manual therapy. Taping is commonly used clinically in the     management of neck pain, however research in this field is sparse.      Methods: Elastic tape was applied over the posterior cervical extensor muscles from insertion     to origin on patients experiencing chronic neck pain. Patients were assessed pre-taping,     immediately post-taping, and one week post-taping and did not receive additional     physiotherapy during the study.      Subjective measures included the Visual Analogue Scale (VAS) for pain intensity, the Neck     Disability Index (NDI) to determine the level of disability in daily living, and the Tampa     Scale of Kinesiophobia (TSK) to assess fear of movement or re-injury. Objective outcome     measures included cervical range of motion, velocity, smoothness, and accuracy of cervical     motion. These kinematic measures were collected using a customised virtual reality system     designed to evaluate neck motion disorders.   "
28254|NCT02915861|"     This is an observational study of patients with scrub typhus (rapid diagnostic     test/quantitative polymerase chain reaction (RDT/qPCR) positive) and an inoculation eschar     present on examination, recruited from Chiangrai Prachanukroh Hospital, North of Thailand.      In this study, we aim to:        -  Investigate relevant pathogen dissemination dynamics, early innate immune response, and          pathogen-host interactions in scrub typhus using a minimal set of easily accessible          samples; the inoculation eschar (crust or biopsy), whole blood and - where possible - a          lymph node fine-needle aspiration (FNA).        -  Determine the potential use of the inoculation eschar for improving early diagnostics          and assessing the diversity of human pathogenic strains; by evaluating non-invasive          swabs and scrapings, as well as biopsies for molecular diagnostics templates.        -  Dissect the underlying patho-biology associated with the inoculation eschar and in a          subgroup, including the draining lymph node; by defining the spectrum of infected cells          via microscopy and double-immune labeling; by determining cytokine and RNA gene          expression profiles in blood peripheral blood mononuclear cell (PBMCs) and eschar          samples.   "
35097|NCT02826382|"     A phase 0 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer     and determination of human dosimetry.   "
28282|NCT02915497|"     The objective of this study is to assess the feasibility and effectiveness of AEPET plus     Resilience Based Therapy (RBT) versus RBT alone for the prevention of PTSD and depression in     trauma patients. The intervention group who have AEPET plus RBT will have reduced level of     post traumatic stress symptoms and depression post sessions as well as reduced symptoms of     PTSD and depression at 4- 6 weeks as compared to the control group who have -Resilience     Based less specific supportive therapy.   "
28255|NCT02915848|"     Movement disorders such as Parkinson Disease, dystonia, and tremor are related to     abnormalities of part of the brain known as the basal ganglia. Recently, it has been     suggested that the basal ganglia works by oscillations (group of neurons cycle between     activation/deactivation when stimulated) of electrical signals. A treatment that involves     insertion of electrodes in the subthalamic nucleus (STN) for electrical stimulation, known as     deep brain stimulation (DBS), is an established treatment for advanced Parkinson's disease.     However its mechanism of action is still not completely understood. Currently, DBS utilizes     an open loop system whereby the stimulation settings are manually adjusted depending on the     patients' clinical response.        1. Determine whether the local field potential (LFP) recorded from the STN is stable over a          1.5 year period.        2. Address whether STN LFP is a suitable control signal, and how it should be used to          change DBS parameters   "
28256|NCT02915835|"     The primary objective of this study is to provide preliminary data on the efficacy (digital     ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to     placebo in patients with scleroderma-associated digital ulcers   "
28257|NCT02915822|"     The aim of this study is to assess the feasibility of conducting a study to compare the     patient recorded and clinical outcomes for the surgical management of Hallux Valgus     correction. A prospective trial will randomise the patients into two groups - Open Scarf/Akin     osteotomy and Minimally Invasive Chevron/Akin osteotomy.   "
28258|NCT02915809|"     The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus     GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.   "
28259|NCT02915796|"     The main aim of the present study was to evaluate the therapeutic potential and safety of     transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of     differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty     (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic     patients.   "
28260|NCT02915783|"     This is a single-arm, multicenter, Phase 2 study of lenvatinib in combination with everolimus     in participants with unresectable advanced or metastatic non clear cell renal cell carcinoma     (nccRCC) who have not received any chemotherapy for advanced disease. The primary objective     of the study is to evaluate the objective response rate (ORR). This study consists of three     phases: a Pretreatment Phase (Screening and Baseline Periods), a Treatment Phase (starting     Cycle 1, Day 1), and a Posttreatment Phase (End of Treatment Visit and survival Follow-up).   "
28261|NCT02915770|"     This study evaluates the clinical application of cholangiojejunostomy in the surgical     treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of     participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the     other half will receive hepatectomy and T-tube Drainage.   "
28262|NCT02915757|"     Suicide, suicide attempts and depression are major social problems. The present research     program focuses on the relationship between electrodermal hyporeactivity, as measured by the     ElectroDermal Orienting Reactivity (EDOR) Test, and suicide and suicide attempts with death     intent in patients with a primary diagnosis of depression. Electrodermal hyporeactivity has     in several publications from different laboratories repeatedly been shown to have a high     sensitivity (up to 97%) and high raw specificity (up to 98%) for suicide. Such levels are     unique in psychiatry. The relationship between suicidal propensity and hyporeactivity can be     considered as strongly significant. Almost all evidence in the topic up today has been     established in research settings with specific exclusion criteria for some secondary     psychiatric and some somatic illnesses. However, it is important to study the relationship     between electrodermal hyporeactivity and suicide in relatively unselected patients regarding     secondary psychiatric diagnoses and somatic diagnoses in a natural clinical ward situation     and milieu. A previous naturalistic study proved that a test of electrodermal hyporeactivity     fits very well into the daily clinical work.   "
28263|NCT02915744|"     This is an open-label, randomized, active comparator, multicenter, international Phase 3     study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain     metastases and have been previously treated with an anthracycline, a taxane, and capecitabine     in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically     appropriate or contraindicated for the patient).   "
28264|NCT02915731|"     This study will assess total body vitamin A pool size, as well as liver vitamin A stores, by     means of stable isotope dilution in preschool children from a South African community where     liver, an exceptionally rich source of vitamin A, is frequently eaten, and the children     exposed to vitamin A fortified staple foods, as well as a vitamin A supplementation     programme.   "
28265|NCT02915718|"     Dilated cardiomyopathy (DCM) causes significant morbidity and mortality and is the third most     common cause of heart failure and the most frequent reason for heart transplantation. The     etiology of dilated cardiomyopathy(DCM) is complex. There is a growing body of literature     suggesting that the humoral immune system activation and autoantibodies against myocardial     generation play an important role in the progression of DCM. At present immunoadsorption     technology has been successfully applied in autoimmune antibody removal treatment of a     variety of diseases. And some applications of immunoadsorption(IA) in patients with DCM     showed that immunoadsorption(IA) can indeed reduce the autoantibodies, improve symptoms and     prognosis, but additional research is needed to identify indications and instruments for the     IA treatment of DCM.   "
28266|NCT02915705|"     UX023-CL301 is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy     and safety of KRN23 with active control (oral phosphate/active vitamin D therapy) in children     with XLH (aged 1 to ≤12 years) who have radiographic evidence of rickets, open epiphyses, and     have received oral phosphate/active vitamin D therapy for ≥ 6-12 consecutive months prior to     screening. Approximately 60 subjects will be randomized 1:1 to receive open-label KRN23     administered by subcutaneous injection or oral phosphate and active vitamin D therapy for a     total of 64 weeks.   "
28267|NCT02915692|"     The Foley catheter is one component in a catheter insertion procedure that could contribute     to a catheter associated urinary tract infection (CAUTI). Improvements in the catheter     insertion procedure using the ERASE CAUTI Tray system may help to lower these infection     rates.   "
28283|NCT02915484|"     The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct     Current Stimulation) on apathy in stroke patients.   "
28268|NCT02915679|"     In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain     where mental trouble has a major influence. It is classified as preventable mortality.     According to interpersonal psychological theory of suicide, the repeated exposition to     stressful and painful events (as physical abuse) would facilitate suicide attempt through the     increased pain tolerance. The social pain (or psychical pain on the broader sense) and     physical pain are closely linked.      The investigators hypothesize that the measure of painful perception will be significantly     superior on suicidals attempters compared to non-attempters. It will be the case for recent     suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait.     Moreover, the investigators expect that social distress induced by a social exclusion     paradigm will be significantly superior on suicide attempters compared to non-attempters.      The aim of the study is to investigate the physical and psychic pain on depressed subjects     with or without history of suicide attempts.      After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal     dimension), subjects will be submitted to a painful thermic stimulation and will participate     at a computer test of social exclusion (named Cyberball).   "
28269|NCT02915666|"     This study is being done to find out if the combination of dabrafenib, trametinib and digoxin     will lessen the side effects that you may experience and to measure your response and     duration of response to the combination of drugs.   "
28270|NCT02915653|"     The study is a pre-post two round, randomized controlled study design of PCPs randomly     assigned to a control or 1 of 2 intervention arms.   "
28271|NCT02915640|"     This study compares the utilization of remote technology versus not using remote technology     when triaging and managing pediatric patients in remote settings prior to pediatric     specialized inter-facility transportation.   "
28272|NCT02915627|"     Study comparing different groups of people and how they respond to application of the     non-pneumatic anti-shock garments. Investigators will divide all recruited participants into     three groups based on health status (group 1: hemodialysis patients; group 2: patients with     severe chronic kidney disease but not on dialysis; group 3: healthy participants with no     clinically known kidney disease). Each group, which will comprise of 10 people, will receive     the same treatment using the non-pneumatic anti-shock garments.   "
28273|NCT02915614|"     In a former study, the investigator observed significant differences in the response to     pulmonary rehabilitation between COPD patients with the normal genetic variant of alpha-1     antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al.,     2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise     capacity compared to PiMM patients. This latter finding was mirrored by an increase of     oxidative myofiber type I proportion - that is important for aerobic exercises in daily life     - in PiMM but not PiZZ patients.      Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to     compare the effects of pulmonary rehabilitation including exercise training on a) specific     enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b)     the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD     patients.   "
28274|NCT02915601|"     Low serum bicarbonate levels, even within the normal laboratory range, are strongly     associated with increased risks of hypertension, endothelial dysfunction, cardiovascular     disease and death. The current proposal will investigate whether bicarbonate administration     in patients with chronic kidney disease (CKD) will improve the health and function of     arteries and reduce the size of the left ventricle of the heart. Overall, the proposed     research will provide important new scientific evidence upon which physicians can base     recommendations to patients with CKD to decrease the risk of developing cardiovascular     diseases.   "
28275|NCT02915588|"     The purpose of the study is to compare two different rehabilitation protocols after     arthroscopic rotator cuff surgery.   "
28276|NCT02915575|"     The purpose of this trial is to test the clinical benefit and feasibility of structured risk     based post discharge care for hospital acquired Acute kidney injury survivors.This is a     Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166     participants will be enrolled in this Randomized controlled trial..   "
28277|NCT02915562|"     The purpose of this study is to determine the effects of depressive mood on outcomes of an     in-house rehabilitation program.   "
28278|NCT02915549|"     To test the hypothesis that progressive feeding without minimal enteral feeding (MEF)     compared to progressive feeding preceded by a 4-day course of MEF will result in an increased     number of days alive on full enteral feeding in the first 28 days after birth in extremely     preterm infants receiving human milk.   "
28279|NCT02915536|"     With the implementation of Universal Salt Iodization (USI) in 1995, China has successfully     combated Iodine Deficiency Diseases (IDD). However, China is a country with a complicated     iodine geographical environment with wide natural variation in the iodine content of drinking     water. It has been reported that the water iodine of at least 11 provinces and cities in     China is high, with nearly 31 million people exposed to the risks of excessive iodine intake.     This has raised a new public health concern that a safe upper level of iodine intake should     be established to ensure that people avoid ingesting excessive iodine intake while continuing     to implement USI to control IDD. The investigators have successfully explored the tolerable     upper intake level (UL) of iodine for Chinese adults by conducting a randomized     double-blinded trial in 256 euthyroid volunteers. However, due to limited data on the safe     upper intake level of iodine for children worldwide, current ULs of iodine for children are     extrapolated from those for adults based on body weight or body surface area. As it is     impossible to ethically conduct a randomized clinical trial regarding excessive iodine intake     in children, the investigators plan an observational study to investigate children who have     been living with different drinking water iodine levels for over 5 years, observing the     changes of thyroid function in response to each iodine exposure level. Subtle changes in     thyroid function and thyroid volume of children corresponding to different iodine intake     levels will be determined, which will contribute to the establishment of UL of iodine for     children.      The aim was:        1. To establish the tolerable upper intake level (UL) of iodine for children of China.        2. To define the adverse effects of excess iodine on children.        3. To monitor the iodine status of children living in high water iodine areas in China.   "
28280|NCT02915523|"     The purpose of this study is to determine the biologically active dose of entinostat, when     given in combination with avelumab, that is safe and warrants further investigation.     Additionally, this study will evaluate the effectiveness of entinostat in combination with     avelumab at the determined dose in terms of progression free survival compared to avelumab     plus placebo in patients with refractory or recurrent epithelial ovarian cancer.   "
28281|NCT02915510|"     This study will evaluate the safety, gastrointestinal (GI) tolerance, acceptability and     compliance of a Glycomacropeptide-based protein substitute for patients with Phenylketonuria     (PKU).   "
28284|NCT02915471|"     The overall aim of this research program is to develop and examine the impact of a Cancer     virtual peer-to-peer (VP2P) Support Program on health-related quality of life (HRQL) in     adolescents with cancer (AWC). In the current proposal, the feasibility of trialing the     Skype-based VP2P program providing peer-support from mentors and the magnitude of program     effect estimates will be evaluated in a pilot randomized control trial (RCT). This pilot RCT     will enable us to refine the program and determine the appropriate sample size for a future     large-scale RCT, which will compare the effectiveness of VP2P to a waitlist control group at     a major Children's Oncology Group- affiliated centers in Canada and the United States.   "
28285|NCT02915458|"     Making a weaning decision for a patient on a mechanical ventilator is an important clinical     issue. The most common index to predict successful weaning is the rapid shallow breathing     index (RSBI), however, the accuracy of RSBI to predict successful weaning have been     questioned.      The investigators proposed a new mathematical model and algorithm, called WIN, which capture     the essential feature of the variability ruling the physiological dynamics to provides better     perdition to wean than RSBI.   "
28286|NCT02915445|"     This study is for patients that have nasopharyngeal carcinoma or breast cancer. As epithelial     cell adhesion molecule (EpCAM) is a well characterized molecule that is closely with poor     prognosis and tumor metastasis and invasion. Many therapies targeting EpCAM have shown     benefits for cancer patients. This study is to determine the safety of the engineered T cells     armed with chimeric antigen receptor (CAR-T) recognizing EpCAM. At the same time, efficacy is     to be evaluated by the criteria of RECIST. The EpCAM CAR-T were produced by lentiviral     transduction of the 3rd generation of CAR genes. Different cohorts of patients receive EpCAM     CAR-T with a dose-escalating manner. This study is to find the largest dose of EpCAM CAR-T,     to learn what the adverse effects are and to find out whether this experimental intervention     might help patients with nasopharyngeal carcinoma or breast cancer.   "
28287|NCT02915432|"     The purpose of this study is to preliminarily evaluate anti-tumor activity of a Recombinant     Humanized Anti-PD-1 Monoclonal Antibody for Infusion (JS001) in treating advanced gastric     adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and     neck squamous cell carcinoma and to determine the recommended phase II dose (RP2D)   "
28288|NCT02915419|"     This study aims to compare the ability of different regenerative protocols in the treatment     of mature necrotic   "
28289|NCT02915406|"     This protocol is designed to enable access to related or unrelated CD34 cells manufactured     using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted     allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include patients     with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow     failure, and other rare diseases amenable to HSCT. Finally, patients with poor graft function     and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell     depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected     using the CliniMACS device ENROLLMENT BY INVITATION ONLY   "
28290|NCT02915393|"     Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of     the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS     would be researched in this project deeply and systematically with modern life-scientific     methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency     syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be     included, and the corresponding research would be conducted at the molecular-cell-gastric     tissue level, and at the same time, systematical biological database of SDS would be built by     systematical biological methods, such as pioneered SPARS sequencing technology created in our     research group, proteomics and metabonomics. Under the above work, the investigators would     conduct data mining and molecular network analysis, and then verify the key functions. By     analyzing the systematical biological features of syndrome and its relationships with     constitution and disease, this study would provide a new basis for objective reality of     syndrome, and also offer a crucial premise of revealing biological basis for syndrome     correctly, which is of important theoretical and practical significance.   "
28291|NCT02915380|"     Recently, the occurrence and potential impact of pituitary dysfunction after aSAH has gained     increasing interest. Several studies have demonstrated pituitary dysfunction after SAH     suggesting that pituitary dysfunction may be a contributing factor for residual symptoms     after SAH. This is an observational multicentric study aimed to test the prevalence of     thyroid abnormalities, other neuroendocrinological dysfunction and their influence on outcome     of patients affected by aSAH.   "
28292|NCT02915367|"     Next generation real-time monitoring for PrEP adherence in young Kenyan women   "
28300|NCT02915263|"     The goal of this pilot study is to obtain preliminary data on the magnitude of the treatment     effect of IVIG on the neuropathic pain and neuropathy severity associated with treatment     induced neuropathy (TIND).      The investigators hypothesize that immune globulin, administered intravenously (IVIG), will     reduce the pain associated with treatment induced neuropathy and reduce the neuropathy     severity.      Treatment induced neuropathy in diabetes, is an iatrogenic complications of diabetes. The     preliminary data will be used to power a larger treatment trial, and to aid the understanding     of the mitigating factors in the treatment response.   "
28301|NCT02915250|"     This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period     cross-over study using a standardised solid meal test in subjects with type 2 diabetes to     investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25     and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate     dosing visits.   "
28302|NCT02915237|"     Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits     such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for     GWI currently available, there is an urgent need to develop novel interventions to alleviate     major GWI clinical complications. Recent evidence highlights the potential value of     flavonoids, a subclass of organic chemical called polyphenols abundantly found in some plants     and common dietary preparations, in helping relieve clinical complications in Veterans with     GWI. The overall goal is to test whether daily consumption of commercially available Concord     grape juice, which is very Flavonoid-rich, is effective for treating cognitive deficits and     chronic fatigue in Veterans with GWI.   "
28293|NCT02915354|"     The inclusion criteria was patients who aged 18 or older with ankylosing spondylitis,     fulfilled the 1984 modified New York criteria for AS. Inclusion criteria enriched the AS     patients with clinical remission, including the following definition: 1. Administration of     etanercept 50 mg for 6-week period at least; 2. Acquisition of Assessment of     SpondyloArthritis International Society criteria 20(ASAS20) response at the end of the     treatment. We excluded patients who have developed to complete spinal fusion. We also     excluded patients with kidney disease induced by other conditions; pregnancy; suckle;     accompany other chronic diseases; various infections in acute stage; and other infectious     diseases. At the end of the trial, patients who fulfilled the inclusions would stop     etanercept treatment. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal     anti-inflammatory drugs could be continued if maintained at a stable dose;Patients were     followed up from the time of etanercept withdrawal per 6 weeks for 3 years by telephone. If     symptoms suggestive of relapse or other problems occurred, patients were invited to come back     to the center. Relapse after etanercept withdrawal was defined as an increase Bath     Spondylitis Disease Activity Index(BASDAI)15 score goes back to 80 percentages of it at the     beginning of the trial16. The following data were collected: demographic and disease     characteristics, therapeutic modification, clinical values (BASFI, Bath Ankylosing     Spondylitis Global Score (BAS-G)), Ankylosing Spondylitis Disease Activity Score (ASDAS)1718)     and biologic values at baseline of the trial and the time of relapse. Adverse events and     other safety measures were also collected.   "
28294|NCT02915341|"     The overall objective of this study is to extend previous work in the development of methods     to automatically detect the timing of cocaine use from cardiac interbeat interval and     physical activity data derived from wearable, unobtrusive mobile sensor technologies. The     specific objectives of this protocol are to characterize under which conditions high quality     continuous interbeat interval data and physical activity data can be obtained from a     specially developed smartwatch device in the natural field setting among a population of     cocaine users. In addition to identifying common failure scenarios and understanding     wearability/usage patterns when collecting interbeat interval from smartwatches, this study     will extend previous work in the detection of cocaine use via interbeat interval and physical     activity data that were previously obtained from wearable chestband sensors. Information from     this study will contribute toward the adaptation of the investigators' existing computational     model for detecting cocaine use via the chest sensors, so it can be applied to the interbeat     and physical activity data obtained from less obtrusive smartwatches.   "
28295|NCT02915328|"     Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The     intra and/or postprocedural cerebral embolization remains the most frequent complication.      The type of carotid stent and of cerebral protection are the two most important variables     potentially affecting the rate of cerebral microembolization. So far there no consensus on     the the best stent and cerebral protection.   "
28296|NCT02915315|"     Essential hypertension is a complex trait which results from interaction between     environmental factors and genetic factors. Our study aimed to detect the differential     expression of LncRNAs and epigenetic changes such as DNA methylation associated with salt     sensitive hypertension in human based on a chronic salt loading study conducted in Lantian     county, China. Firstly, a chronic salt loading study will be conducted in a Chinese     population to differentiate salt-sensitive and salt-resistant individuals. Second, LncRNAs     and DNA methylation Chip analysis will be performed using samples collected from     salt-sensitive and salt resistant individual, and the results will be analyzed by modern     bioinformatics methods to seek for differential genetic markers. In addition, the     investigators also try to examine the effects of chronic salt loading on BP, ambulatory BP,     microalbuminuria and baPWV and other biochemical indexes. This project had great significance     to reveal molecular genetics mechanism in the development of salt, salt-sensitive and     hypertension.   "
28297|NCT02915302|"     The aim of the study is to describe the safety and immunogenicity of the 0.5-mL dose (15 μg     HA per strain) of Fluzone Quadrivalent vaccine in children 6 through 35 months of age.      Primary objective:        -  To compare the rate of any fever (temperature ≥ 100.4°F [38.0°C]) following the 0.5-mL          dose of Fluzone Quadrivalent vaccine to that following the 0.25 mL dose of Fluzone          Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2          combined) in subjects 6 to < 36 months of age.      Secondary objective:        -  To compare antibody responses induced by the 0.5-mL dose of Fluzone Quadrivalent vaccine          to those induced by the 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by          geometric mean titer (GMT) ratios and seroconversion rate differences after the final          vaccination in subjects 6 to < 36 months of age.      Other objectives:        -  To describe the safety of 2 different dose levels of the 2016-2017 formulation of          Fluzone Quadrivalent vaccine in subjects 6 to < 36 months of age.        -  To describe the immunogenicity of 2 different dosages of the 2016-2017 formulation of          Fluzone Quadrivalent vaccine in subjects 6 months to < 36 months of age.        -  To submit available sera from approximately 30 subjects to the Center for Biologics          Evaluation and Research for further analysis by the World Health Organization, the          Centers for Disease Control and Prevention, and the FDA to support formulation          recommendations for subsequent influenza vaccines.   "
28298|NCT02915289|"     Endometritis, an infection of the uterus in the postpartum period, has been shown to     complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal     cleansing prior to cesarean delivery has been shown to minimize the presence of     micro-organisms and risk of infection. Although povidone-iodine is the most commonly used     anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's     diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine     gluconate, on the other hand, has demonstrated superior disinfectant properties in several     clinical trials, as compared to povidone iodine. In this randomized, comparator controlled,     study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for     intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.   "
28299|NCT02915276|"     For the purpose of this study, the investigators will perform the removal of trophectoderm     (TE) the cells as required for the purpose of pre-implantation genetic screening, in order to     perform the genetic analysis. Additionally, the investigators will remove the blastocoelic     fluid (BF) and perform additional genetic analysis on the embryo in order to determine the     agreement of the genetics results between TE cells and BF.   "
28306|NCT02915185|"     A substantial proportion of individuals are left with poor residual functioning of the     affected arm after a stroke. This has a tremendous impact on the quality of life and the     ability for stroke survivors to live independently. While exercise is considered essential to     any rehabilitation program, its benefits are generally far from optimal because of the lack     of proper dosing in terms of intensity. One way to tackle this problem is to develop better     tools that could predict an individual's potential and then adjust the intensity of exercise     accordingly. One such predicting tool exists and consists of using non-invasive brain     stimulation such as transcranial magnetic stimulation (TMS), to assess the integrity of     descending motor pathways originating from the brain. TMS consists of applying a magnetic     wand near the scalp to stimulate brain cells without inducing pain or discomfort. One goal of     the current proposal is to use TMS to test the integrity of the motor pathway in chronic     stroke survivors. The level of responses to TMS will be used to classify participants in     terms of potential for recovery and then, to determine the optimal level of exercise. The     study will also examine the effect of another non-invasive brain stimulation technique called     transcranial Direct-Current Stimulation—tDCS to determine whether it can enhance the response     to strength training exercise in the affected arm. Half of the participants will be trained     with the tDCS on, while the other half will be trained with the stimulator off. The training     program will last 4 weeks; 3X/week. Both clinical and neurophysiological measures will be     performed to determine the impact of the strength training intervention on participants.     Overall, the proposed project is expected to have a positive and significant impact on stroke     survivors' quality of life.   "
28307|NCT02915172|"     There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).      The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of     lenvatinib and Xeloda (capecitabine) that can be given to patients with advanced cancer. The     goal of Phase 2 of this study is to learn if the dose of lenvatinib and capecitabine found in     Phase 1 can help to control advanced cancer.      The safety of this drug combination will be studied in both phases of the study.   "
28309|NCT02915146|"     Narrowband ultraviolet B phototherapy is the standard phototherapy for atopic eczema;     ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the     most important chromophores in treating atopic eczema; in which phototherapy is thought to     work by improving epidermal barrier function, having beneficial effects on skin microbiome     and local immunosuppression. It seems plausible that there are several chromophores and that     'targetting' several at once with different wavebands should help and for severe eczema that     has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is     sometimes used. This study is to test if the combination is moderately to greatly more     effective than narrowband ultraviolet B monotherapy amongst patients referred for any form of     first-line phototherapy for atopic eczema.   "
28310|NCT02915133|"     Macular foveoschisis (MF) is a common complication of pathological myopia, which is     characterized by choroid-retinal degeneration and vision impairment. Although pars plana     vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of     recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular     buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma,     and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT)     is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an     objective examination for visual evaluation. To our knowledge, there is a lack of data on the     comprehensive visual function evaluations of MF patients associated with OCT findings. Our     clinical trial aims to provide the structural and functional relationship in MF patients     undergoing MB surgery, and find out potential factors to determine the visual prognosis.   "
28311|NCT02915120|"     The purpose of this study is to determine if patients with chronic painful knee     osteoarthritis experience meaningful and long-term improvement in pain, function, and     analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following     a double diagnostic genicular nerve blocks.   "
28312|NCT02915107|"     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX     STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting     BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with     ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary     intervention (PCI).   "
28313|NCT02915094|"     Objective of the study is to gain knowledge about the administration of Kineret in patients     with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the     current survey, the investigation of the response rate of Kineret regarding the date of onset     of action, the efficacy, as well as the tolerability and safety are of particular interest.   "
28315|NCT02915068|"     The investigators propose to modify and expand the internationally-recognized evidence-based     Physician Asthma Care Education (PACE) program to make it a suitable tool for training     primary care clinicians on the effective use of EHRs at the point of care. The investigators     will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of     best practices for clinicians interacting with patients in the presence of computer systems     in the exam room. They will then establish the feasibility and potential impact of EHR-PACE     via a randomized design on 125 patients of 20 physicians who receive the intervention on the     following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the     physician's performance, asthma control, and asthma-related quality of life. Outcomes will be     assessed on patients, but physicians will receive the intervention. Patients will not know     which arm their doctor was randomized to. The pilot trial will compare two groups of primary     care physicians who see patients with asthma in clinics equipped with certified EHRs. It is     hypothesized that patients of physicians who receive EHR-PACE training will achieve better     outcomes compared to physicians who do not receive EHR-PACE.   "
28316|NCT02915055|"     This will be a single-center, prospective observational study. The study will compare     post-operative pain scores and narcotic consumption between two groups of patients - one     cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other     cohort will receive only Percocet. Both pain management options are considered to be standard     of care.      The primary objective of the study is to compare patients' reported pain and narcotic use     following meniscectomy, and determine if NSAIDs can provide adequate pain relief.   "
28317|NCT02915042|"     The primary objective of this study is to evaluate the efficacy of administering intravenous     dexmedetomidine as a single preemptive dose to placebo in reducing the total 24 hour dose of     opioids as measured on a weight adjusted morphine equivalent basis.   "
28318|NCT02915029|"     People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD).     CKD is associated with increased risks for heart disease and death. The burden of chronic     kidney disease is increased among minority populations compare to Caucasians. The Zuni     Indians are experiencing an epidemic of chronic kidney disease is due primarily to the high     rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed     to delay / reduce rate of ESRD by early interventions in CKD. Investigators propose to assess     the safety and efficacy of conducting a full-scale study to determine if home based care     delivered by a collaborative team composed of community health workers and University of New     Mexico faculty will decrease the risk for the development and the progression of CKD.   "
28319|NCT02915016|"     This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in     combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent     Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.   "
28320|NCT02915003|"     With the help of local focus groups, the investigators are designing and testing a website to     help urban people have better access to health care through understanding their insurance     options better. They hypothesize that once individuals engage with the website and go through     all of its modules, they will: 1) become more informed consumers of the ACA and its health     insurance options; 2) enroll in an insurance plan; and 3) better leverage the benefits of     their existing plans.   "
28321|NCT02914990|"     The main objective of this study is to evaluate the safety and tolerability of BPI-15086.   "
28322|NCT02914977|"     In this pilot study, eligible patients will be treated with 5 days of low dose daunorubicin     for one cycle only. Any patient who receives treatment on this protocol will be evaluable for     toxicity. Each patient will be assessed for the development of toxicity at all scheduled     visits (Days 1-5). Following participation on this brief pharmacodynamic trial, patients can     then proceed to other conventional or investigational therapies, as clinically indicated.   "
28323|NCT02914964|"     The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and     the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with     relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow     their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets     for 24 weeks.   "
28324|NCT02914951|"     In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder     (ASD) often exhibit disruptive behavior problems including irritability, tantrums,     noncompliance, and aggression. The purpose of this study is to investigate     cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum     disorders and intellectual disability. This pilot study will include children with ASD and IQ     between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity     of activities during therapy sessions but retains all key elements and principles of CBT.     Assessments of irritability and disruptive behavior will include clinical interviews, parent     ratings and child self-report measures. Study participants will be asked to complete     functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and     emotion regulation before and after CBT.   "
28325|NCT02914938|"     The purpose of this study is to determine the minimum biologically effective dose of ME-401;     determine the maximally tolerated dose of ME-401 and determine the dose limiting toxicities     of ME-401. Secondary objectives to evaluate the safety profile and efficacy of ME-401.   "
28335|NCT02914808|"     The chroedem study is aiming to assess tissue and biomolecular components of chronic lower     limb oedema (CO). The investigators working hypothesis is that according to the aetiology of     CO, the proportion of oedema & composition of peri-oedema tissues (fat, muscle,     fibrosis/inflammation) might differ and could at least in part explain differences in     failure/success of compressive therapies from one patient to another. For that purpose, 24     patients with a post-thrombotic syndrome (PTS)-related oedema and 24 patients with a primary     lymphedema will undergo a magnetic resonance imaging (MRI)) of the legs and biological     (genetic) testing.   "
28388|NCT02914119|"     Aim: To explore        -  the frequency of use of objective neuromuscular monitoring for assessment of depth of          neuromuscular blockade in general anaesthesia        -  the incidence of residual neuromuscular blockade, and        -  the timing of reversal of the neuromuscular blockade at the end of anaesthesia.      We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia     Information Management System (AIMS).   "
28326|NCT02914925|"     The purpose of this study is to assess the use of a commercially available arm weight     supporting training system (Armeo®Spring) in conjunction with Constraint Induced Therapy     (CIT) for improving upper extremity function for children with unilateral cerebral palsy. In     addition, the study aims to assess the potential cortical changes with Armeo®Spring therapy     and CIT with the use of the Transcranial Magnetic Stimulation (TMS) motor mapping.      This within-subjects repeated-measures study will be conducted at St. Mary's Hospital for     Children. Subjects will be recruited from the general population. A sample size of 10     participants is required for the study. Minority and gender distributions of this study are     expected to reflect the distributions in the general population of this region.      Therapy: Participating children will have their unaffected arm placed in a sling. The sling     is placed at the start of the day and the child is encouraged to have this on during all     therapy sessions.The affected arm will be used for repetitive therapeutic activities.Therapy     sessions will include activities aimed at building motor learning skills.      TMS will be used to map the brain. Participants will have MRI of the brain that is T1     weighted with 0.9 -1.1 voxel. size to allow for on-screen navigation of the cerebral cortex     while performing TMS.The stimulating coil will be held to the scalp over each M1 hemisphere     and an induced electrical current passed through the coil will create a magnetic pulse that     stimulates the brain      Children will be assessed using functional hand tests and TMS.   "
28327|NCT02914912|"     Patients suspected for chronic mesenteric ischemia shall be investigated With gastroscopy     assisted laser Doppler flowmeter and spectrometer (GALS).   "
28330|NCT02914873|"     A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due     to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative     treatment only when and if signs of tumor progression occur. There are however a number of     uncertainties in AS, the most important being when to initiate treatment. The investigators     are therefore starting a large randomized multicenter trial testing a standardized active     surveillance protocol with specified triggers for repeat biopsies and initiation of curative     treatment. The standardized protocol is compared with current practice for active     surveillance. The primary aim of the study is to reduce overtreatment and subsequent side     effects, without increasing the risk of disease progression or prostate cancer mortality.   "
28331|NCT02914860|"     The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity     in patients with different forms of atrial fibrillation and within a sub-group of healthy     subjects.   "
28332|NCT02914847|"     Self-harm has substantial personal impacts as well as costs on the National Health Service     (NHS). Around 13-17% of young people report experiences of self-harm. In Cambridgeshire, this     is a significant issue with the number of admissions to hospital for self-harm in young     people being higher than the United Kingdom (UK) average. Treating underlying mental illness     can lead to a reduction in self-harm, but these are long interventions for complex disorders     and many people who self-harm are not under treatment for mental illness. Moreover, young     people struggle to access traditional mental health services where these therapies are     delivered. No short interventions specifically tailored for young people have been developed     so far.      The Imaginator project aims to address the urgent need for an effective and innovative     short-term therapy for self-harm in young people. The investigators will pilot a new     imagery-based psychological intervention for young people aged 16-25 who experience     repetitive self-harm. Mental imagery (the experience of seeing through the mind's eye) can     carry intense emotions (positive and negative), and imagining something can facilitate     behaviour. Imagery-based therapies have proven useful (i) for problems that feature intense,     hard to manage emotions such as those associated with self-harm, and (ii) for promoting     healthy behaviour. Our new intervention called Functional Imagery Training will support young     people to imagine more adaptive behaviours to cope with the emotional distress that triggers     self-harm, and motivate them to reduce self-harm. Imaginator will comprise of just two     sessions followed by phone support over three months.      Moreover, the investigators will address the challenge of young people accessing and staying     in therapy by using a smartphone app to support the therapy, as apps are widely used and     favoured by this age group. The app will enable participants to continue with the strategies     they have learnt in therapy by themselves, thus ensuring a potential longer-term benefit and     self-empowerment.   "
28333|NCT02914834|"     This pilot study aims to determine if it is possible to perform acupuncture on women     diagnosed with stable angina who have symptoms. The investigators want to determine if     acupuncture reduces the pain and other symptoms of angina. The investigators also want to     examine whether this study is acceptable to the participants, and by carrying out this study     the investigators will be able to tell how many participants they will need in a future     larger study to further test acupuncture to reduce the symptoms of angina in women.   "
28334|NCT02914821|"     The study will take place at a cafe managed by university dining services and is located in a     university building adjacent to the psychology building. The cafe sells sugar-sweetened     beverages and a variety of diet drinks. The campus dining services and the manager of the     cafe have given investigators permission to tax their sugar sweetened beverages and will     provide their sales data for a 12 week period.      The investigators will introduce four arms to the experiment. One arm will be baseline data     where business 'as usual' will be conducted and no price increases will be implemented on     SSBs. In the general tax condition the investigators will introduce a 3 cent/ounce tax on the     five SSB flavors the café offers. In the Pre-K tax condition the investigators will institute     a 3 cent/ounce tax but will label the tax as proceeds going to Pre-K education. This is     designed after the Philadelphia tax that was recently passed where funds were earmarked to     benefit childhood education. In the childhood healthy eating program condition the     investigators will institute a 3 cent/ounce tax but will label the tax as proceeds going     toward childhood healthy eating programs. In all tax conditions the firm will keep the     proceeds, but the research team will make a donation to a Pre-K education non-profit and a     childhood healthy eating non-profit of the amount generated by the tax during the study     period.      Each experimental arm will run for 3 weeks total (for a total study period of 12 weeks). The     conditions will alternate by week (i.e., week 1: business as usual; week 2: general tax; week     3: pre-K tax; week 4: childhood healthy eating tax; week 5: business as usual, etc). A     research assistant will visit the café each week to make any necessary changes to signs that     will label the drinks.      The investigators will change the signage of the drinks in the cooler during the study     period. For the baseline period there will be no changes to the signs made. Currently all     beverages are labeled with their name and cost (e.g., Pepsi, $1.89). In the tax conditions     the investigators will change the price of the drink (3 cents/ounce) and add a line notifying     consumers of the soda 'surcharge' (note surcharge will be used in the study because no tax     was actually passed by the local government). An example of this sign would be 'Pepsi, $2.29,     includes 40 cent sugary drink surcharge.' In the Pre-K tax condition an added line will say,     Pepsi, $2.29, includes a 40 cent sugar sweetened beverage surcharge. Proceeds benefit Pre-K     education. In the childhood healthy eating programs condition the text will say, Pepsi,     $2.29, includes a 40 cent sugary drink surcharge. Proceeds benefit Childhood Healthy Eating     programs.   "
28372|NCT02914327|"     SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of     the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome     ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the     addition of SNX-5422 to an established dose of ibrutinib will result in the removal of     mutated BTK from blood mononuclear cells and/or prevents or delays disease progression of     subjects with CLL   "
28336|NCT02914795|"     Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due     to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath     lab. Therapy usually consists of one or more stent implantations. After implantation of a     coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet     inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of     the individual platelet function is valuable.      Several factors potentially promote a delayed or reduced mode of action of platelet function     inhibitors in resuscitated patients:        1. oral administration is impossible and medication needs to be administered via a gastric          line.        2. gastric absorption is delayed after resuscitation        3. according to current guidelines patients are treated with therapeutic hypothermia.          Including the time of rewarming cooling period is ~48h   "
28337|NCT02914782|"     Critically ill patients need intravenous fluid therapy in order to correct or prevent     problems with their fluid and/or electrolyte status and for renal protection. The decision     for the optimal composition and amount of IV-fluids can be difficult and complex. It is well     known that errors in fluid- and electrolyte management contribute to overall morbidity and     mortality. For decades, urinary sodium was used to diagnose renal disease. Nevertheless,     renal excretion of sodium is largely impaired in critically ill patients, particularly in     patients with acute kidney injury. Due to the high frequent measurement of renal output, it     would be possible to measure the urinary electrolytes and its relative changes. Urinary     electrolyte measurement may alert for the presence of the development of an akute kidney     injury before occurring increases in creatinine or oliguria. The rationale of this     investigation is therefore to collect data related to fluid- and electrolyte management from     critically ill patients in order to find patterns of fluid- and electrolyte imbalances which     may lead to disturbances and further, may allow an early detection of acute kidney injury.   "
28689|NCT02910128|"     This study evaluates the effect of the education innovation programchiquichefs on     anthropometric variables, quality of life and nutritional habits in an elementary school     children. Compared with a control group of the same age but in another school.   "
28338|NCT02914769|"     The purpose of the present trial is to test the efficacy of Ayahuasca in treatment-resistant     depression. Ayahuasca is a decoction of two plants, long used by Amazonian Amerindians.     Traditionally, it is prepared by decoction of a bush (Psychotria viridis) with a liana     (Banisteriopsis caapi). P. viridis is a rich source of N,N-dimethyltryptamine (DMT), a     serotonergic agonist, and B. caapi contains potent monoamine oxidase-A inhibitors (MAOi-A),     such as harmine, harmaline. The study is designed as a randomized placebo controlled trial     with two parallel arms, and it will also evaluate changes of different biomarkers of     depression including anatomical and functional Magnetic Resonance Imaging (MRI), serum levels     of BDNF, TNF-a, cortisol, IL-6, and IL-10, polysomnography, neuropsychological, psychiatric     scales and questionnaires.   "
28339|NCT02914756|"     Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery     from severe sepsis/septic shock, similar to what has been observed in mice? Do patients     recovering from severe sepsis/septic shock suffer from cognitive impairment and is such     impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from     patients recovering from critical illness without prior sepsis?   "
28340|NCT02914743|"     The purpose of this research intervention is to assess the oral health status and periodontal     health of patients with diabetes hospitalized on a general medicine service, and to assess     the effect of providing dental prophylaxis and motivational interviewing to patient     health-seeking behaviors and provider attitudes towards oral health, as well as on patient     health outcomes.   "
28341|NCT02914730|"     In this cross-sectional study the investigators will examine two populations: young adults     with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on > 2 insulin     injections per day. The sample size for this observational study will be up to 125 patients.     The investigators will issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on     the end of Solostar Lantus and Apidra insulin pens; this pen cap registers the position of     the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone     app.   "
28342|NCT02914717|"     Ulcerative colitis (UC) is a chronic inflammatory condition causing continuous mucosal     inflammation of the colon, which is accompanied by episodes of bloody diarrhoea and abdominal     pain. Both infliximab and adalimumab have been used with success for moderate-to-severe UC     refractory to conventional therapy. More recently, golimumab, another anti-TNF antibody, has     been added to the treatment armamentarium.      In the multi-centre, double-blind, placebo-controlled PURSUIT trial, patients with     moderate-to-severe UC randomized to induction therapy with golimumab (200-100 mg, or 100-50     mg at week 0 and 2) achieved clinical response, clinical remission and mucosal healing more     frequent than patients randomized to placebo. In the PURSUIT maintenance trial, patients     randomized to golimumab every four weeks (100 or 50 mg) maintained clinical response through     week 54 significantly more often than patients randomized to placebo. Data on the use of     golimumab in daily clinical practice are unavailable.      The aim of the retrospective Belgian multi-centre BE-SMART trial is to evaluate the mid-term     outcome of golimumab in patients with moderate-to-severe colitis. The primary endpoint will     be steroid-free golimumab continuation at week 26. Secondary endpoints will include     (steroid-free) clinical remission, (steroid-free) clinical response, (steroid-free) mucosal     healing, (steroid-free) complete mucosal healing hospitalization-free survival, and     colectomy-free survival.   "
28343|NCT02914704|"     MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and     effective method in treating uterine fibroids and also adenomyosis. However, systematic     studies on the effect of this treatment on factors affecting fertility are still lacking.     Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this     study is to obtain more information on the systemic response of the body to the     HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU     on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis and     with no wish for further pregnancies will be selected for this study and treated using     MRI-HIFU. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire     will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and     endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and     12 months after the treatment. From these samples detailed analysis of the immunological,     inflammatory and hormonal response will be performed. As this is the first study in Finland     of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy     of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in     assessing the treatment outcome would be the UFS-QoL questionnaire.   "
28344|NCT02914691|"     Background: SGLT2 inhibitors are the first antiglycaemic drugs with a direct renal action. A     part from reducing blood glucose, systemic blood pressure and albuminuria are decreased,     while natriuresis is increased.      Previous research into urinary peptide patterns (proteomics) has revealed that patients in     risk of progressive renal disease display a risk peptide pattern in their urine, ahead of     decline in renal function. Furthermore a urinary proteome pattern is related to CVD risk.      The long-term impact of dapagliflozin (dapa) treatment on renal parameters is unknown, but     long term randomized trials are ongoing. By investigating the impact of dapa treatment on     this peptide pattern, it will be determined whether this intervention can improve the urinary     proteomic peptide pattern. In addition new knowledge regarding renal processes that the     treatment influences is sought.      The impact of treatment of urinary and tubular markers of oxidative stress and function     (metabolomics) will be assessed. These markers are thought to represent one of several     deleterious pathways involved in the pathology of diabetic renal disease, and here the impact     dapa treatment will be investigated. Improvement of these markers of oxidative stress may     indicate long-term benefit.      Objective: The primary objective is to assess the impact of three months of treatment with     dapa 10 mg once daily or placebo on renal proteomics pattern and other risk markers of     diabetic comorbidity.      Design: Double blinded, randomized, placebo-controlled crossover, single center study.     Treatment period: 2 x 12 weeks.      Patient population: 40 patients with type 2 diabetes recruited from Steno Diabetes Center in     accordance with the study in- and exclusion criteria.      Intervention: Dapa 10 mg daily vs. placebo. Endpoints: Primary outcome: To evaluate the     effect of dapa treatment on urinary proteomic patterns in patients with type 2 diabetes,     microalbuminuria and eGFR equal to or above 45 ml/min/1.73m2.      Secondary endpoints are the effect of the intervention on other markers for tubular function,     inflammation, endothelial dysfunction, microcirculation, kidney function, albuminuria,     vasoactive hormones in plasma, and effect on global longitudinal strain as measured by     echocardiography.      Timeframe: Randomisation planned from June 2015, inclusion over the following 9 months. Last     patient is expected to be completed October 2016. Data analysis completed December 2016,     presentation autumn 2017 and publication early 2018.   "
28364|NCT02914431|"     The purpose of this study is to determine whether personalized titanium plates can achieve     better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic     surgery, and evaluate the feasibility of this technique in clinical application.   "
32997|NCT02853851|"     This study aims to construct and validate an international professional perceived stress     scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive     Care Units).   "
28345|NCT02914678|"     In a previous study the investigators evaluated the apparent efficacy and safety of     intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4)     out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe     pain [numeric rating scale (NRS, 0-10) > 3] at hospital arrival. The number of patients with     possible fentanyl-related side effects was low.      Therefore, the aim of the present study is to explore the efficacy and safety of a     liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per     transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport).     The investigators hypothesize that:        -  A higher proportion of patients will experience sufficient pain relief at hospital          admission (NRS < 4) using the liberalized protocol and        -  There will be no differences in the proportion of potential fentanyl related          side-effects are observed.   "
28346|NCT02914665|"     This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac     and renal effects of short term treatment with elamipretide in patients hospitalized with     congestion due to heart failure   "
28347|NCT02914652|"     The overall objective for this study is to test whether β2-agonists will affect the     cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and     healthy age- and gender-matched controls.   "
28348|NCT02914639|"     The primary purpose of this study is to evaluate the safety and exploratory efficacy of     SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular     Degeneration (AMD).   "
28349|NCT02914626|"     Neovascular glaucoma is a potentially blinding condition characterized by the growth of     newvessels at the anterior part of the eye. This growth is driven by the overexpression of a     protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as     diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular     pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order     to decrease VEGF formation. The investigators postulate that the use of anti-VEGF     intravitreal injections may accelerate recovery and decrease the need of surgery in cases of     neovascular glaucoma.   "
28350|NCT02914613|"     The primary purpose of this study is to evaluate the safety and exploratory efficacy of     SF0166 Topical Ophthalmic Solution in patients with Diabetic Macular Edema (DME).   "
28351|NCT02914600|"     The primary objective of this study is to observe the long-term safety of filgotinib in     adults who have completed or met protocol specified efficacy discontinuation criteria in a     prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).   "
28352|NCT02914587|"     To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair     follicle implantation method following a nine month period of post-procedure evaluation.   "
28353|NCT02914574|"     This study primarily aims to investigate arthrogenic muscle inhibition (AMI), an underlying     mechanism in patellofemoral pain (PFP), which remain to date understudied. Although, studies     have revealed that AMI needs to be eliminated before improvements in muscle strength can be     achieved, to date quadriceps muscle inhibition in patients with PFP remains understudied. To     date the influence of AMI on functional performance and the direct link to pain in patients     with PFP remain unclear. This study aims to investigate the link between AMI to pain,     functional performance and how an acute treatment can affect functional performance and pain.   "
28355|NCT02914548|"     The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in     patients with atopic dermatitis.   "
28356|NCT02914535|"     The primary objective of this study is to observe the long-term safety of filgotinib in     adults who have completed or met protocol specified efficacy discontinuation criteria in a     prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).   "
28358|NCT02914509|"     To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost     drug product, placed in the canaliculus of the eyelid in the treatment of subjects with     open-angle glaucoma or ocular hypertension.   "
28359|NCT02914496|"     For many people living with type 1 diabetes it is a challenge to achieve good glucose     control. Barely 20% reaches the goal level and many people experience self-care as complex,     demanding and stressful. The purpose of this study is to evaluate the effect of a     stress-management program on glucose control, self-care and psychosocial factors. The program     is based on Acceptance and Commitment Therapy (ACT), a specific form of Cognitive behavior     therapy (CBT). A total of 70 adult patients with type 1 diabetes from Ersta hospital will be     recruited. Half of them will receive the intervention and the other half will continue with     their regular diabetes care. A licensed psychologist specialised in CBT and a diabetes     specialist nurse will be leading the intervention that is given in a group format. The     program consists of seven 2-hour sessions given over 14 weeks. Glucose control, self care and     stress will be measured at inclusion, after session four and seven, at six , 12 and 24 months     and finally after 5 years   "
28360|NCT02914483|"     The Women's HARP study is a multi-center study focusing on women with clinical presentation     of myocardial infarction (MI). Women will complete stress questionnaires following     presentation to the medical center with elevated cardiac enzymes and abnormal     electrocardiograms (ECGs). 2 months following MI, participants will be screened for the     Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported.     After completing baseline assessments, participants will be randomized to Enhanced Usual Care     (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.   "
28361|NCT02914470|"     This is a single centre, 3+3, dose finding, open label, phase 1b clinical study of     carboplatin and cyclophosphamide, in combination with atezolizumab.   "
28362|NCT02914457|"     The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by     multipoint LV pacing (either simultaneously or sequentially) in comparison to the response     achieved by the current (standard) BiV pacing configuration in patients indicated/recommended     for cardiac resynchronization therapy.   "
28363|NCT02914444|"     Monitoring data during anesthesia of surgical patient in the operation room will be collected     and stored into the registry automatically. Patients' information and preoperative assessment     from medical records will be included. Furthermore, intraoperative events will integrated and     entered in the registry.      The purpose of the registry is to establish an automatic and accessible database of surgical     patients for further retrospective studies.   "
28365|NCT02914418|"     This study will investigate how repetitive transcranial magnetic stimulation (TMS) using     intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as     pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive     stimulation of the cortex, and can modulate activity of neurons. The purpose of this study     will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor     dysfunction in people with incomplete spinal cord injury affecting the upper limbs.   "
28366|NCT02914405|"     Neuroblastoma, the most common extra-cranial solid tumour in children, remains one of the     major challenges in paediatric oncology. A promising way to further improve outcome in this     disease appears to be the development of adjuvant therapeutic strategies. In this research     the anti-GD2 antibody, which is a standard treatment, is to be combined with 131-l     Metaiodobenzylguanidine (mlBG) and anti-Programmed Cell Death Protein 1 (anti-PD1) antibody     Nivolumab - the investigated drugs - with the aim of generating sustained anti-neuroblastoma     immunity. In particular it will be determined the safety and tolerability of the novel     combination as well as documented any evidence of efficacy in paediatric patients with     relapsed and refractory high risk neuroblastoma.      This study is sponsored by the University Hospital Southampton and will take place in 4     hospitals in the United Kingdom, Germany and USA. The estimated duration of the study is 2     years, starting in December 2016.      This is an adaptive study. Such design uses accumulating of data from the ongoing trial to     modify aspects of the study (e.g. duration, number of treatments) without undermining its     validity or integrity. There will be 3 cohorts of patients. As safety of Nivolumab is well     established, Cohort 1 will assess its safety and tolerability in combination with 131-l mlBG.     Cohort 2 will then add anti-GD2 to the drug combination, assessing safety and tolerability.     Cohort 3 will escalate all 3 agents to the full 100% dose level to assure safety for expanded     analyses of clinical and laboratory data at that dose level.      Patients will initially be recruited into Cohort 1. Patients must have completed at least 12     weeks of trial treatment without reaching a Dose Limiting Toxicity before a patient can be     recruited to the next cohort.      A minimum of 3 evaluable patients will be treated in cohorts 1-3. Assuming the full dose     combination therapy (cohort) is tolerable, 15 evaluable patients will be treated.   "
28367|NCT02914392|"     The objective of this study is to research the relationship between maternal exposure to     environmental factors and fetal congenital heart disease in a community-based case-control     study.   "
28368|NCT02914379|"     The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how     long it takes the body to get rid of it. In addition, the safety and tolerability of the     study drug will be evaluated.      Participants will be admitted to a clinical research unit (CRU) the day before dosing.     Participants remain confined to the CRU for at least 7 days. Participants may be discharged     from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days     post-dose (Day 22).      This study will last approximately 30 days for each participant, not including screening.     Screening is required within 28 days prior to the start of the study.   "
28369|NCT02914366|"     The present study will test the hypothesis that the medication Ambroxol is safe and well     tolerated and will improve cognitive and motor symptoms of Parkinson's Disease Dementia     (PDD). Ambroxol has been shown to raise the levels of the enzyme beta-glucocerebrosidase     resulting in lower the levels of the protein alpha-synuclein, both of which have been shown     to improve cognition in mouse models. This will be a 52 week trial of Ambroxol in 75 patients     with PDD. Patients will undergo clinical, neuropsychological and neuroimaging assessment     throughout the study to assess changes.   "
28370|NCT02914353|"     This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile,     and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV     administration of single ascending doses in healthy normal volunteers, and following     continuous IV infusions of multiple ascending doses in healthy normal volunteers.   "
28371|NCT02914340|"     This is a multicenter, prospective study designed to evaluate performance of the SVS in the     REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12     sites with up to 6 patients per site.   "
28374|NCT02914301|"     Prenatal care is defined as preventive healthcare characterized by regular check-ups by     doctors or midwives to treat and prevent potential health problems throughout the course of     the pregnancy. The investigators propose that a mobile app for prenatal care has the     potential to provide patient-tailored, risk-appropriate prenatal educational content and may     facilitate vital sign and weight checks between visits. The investigators describe the     methods used to develop and test the effectiveness of a mobile app for prenatal care to     safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of     care.   "
28375|NCT02914288|"     Intracranial artery disease has been more detected with development of HR-MR. HR-MR can     depict vascular wall directly and give us more information beyond the pre-existing imaging     modalities such as digital subtraction angiography, magnetic resonance angiography, computed     tomography angiography. Hence, HR-MR is considered to become promising imaging modality for     intracranial artery disease and many studies have been published recently. However, there was     not enough to differentiate various intracranial artery disease such as atherosclerosis,     dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real     clinical arena, intracranial artery disease is too difficult to diagnose and distinguish     among the disease. Of the disease, usefulness of HR-MR has been consistently published in the     detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be the     most important and reliable imaging method in intracranial artery dissection as of now.     Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial     artery dissection is dynamic vascular pathology. The geometric change is the most common     among intracranial artery disease. However, there was no report about the geometric change in     HR-MR. The investigators acquired retrospective data about the natural course of intracranial     artery dissection in HR-MR and are preparing for publishing an article. However, the data is     not prospective and not intraindividual comparison. Therefore, reliability is not enough to     convince the natural course. If the investigators got prospective and intraindividual data,     definite natural course of intracranial artery dissection could be acquired and would be     helpful to diagnose the dissection and differentiate from other vascular pathologies. The     prospective longitudinal information from this study could guide us as the important map on     the confusing HR-MR findings. The protocols for imaging are as follows: initial (optional), 1     month, 3 month, 6 month (optional), 12 month.   "
28376|NCT02914275|"     This is a study to assess the immune (antibody) response and safety of a Seqirus split     virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US     licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric     population 6 months through 59 months of age.   "
28377|NCT02914262|"     This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I     study in healthy male subjects.   "
28378|NCT02914249|"     This study aimed to verify if combination of a low calorie diet and orange juice consumption     results in weight loss and ameliorates metabolic obesity-related biomarkers.   "
28379|NCT02914236|"     Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.   "
28380|NCT02914223|"     The main objective of the study is to investigate the rate and routes of elimination of     cenerimod and the mass balance in urine, feces, and expired air   "
28571|NCT02911883|"     The purpose of this study is to assess the repeatability and reproducibility of measurements     of the vascular structures and the anatomical structures of the posterior pole of the eye     based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.   "
28381|NCT02914210|"     The goals of this research study are the following:        1. To compare the effects of tele-rehabilitation-supported physical therapy versus          traditional home and/or clinic-based physical therapy for total knee replacement (TKR)          on 90-day health service use costs.        2. To compare tele-rehabilitation-supported physical therapy and traditional physical          therapy on patient-centered outcomes        3. To explore whether individual patient characteristics are associated with differential          improvement from 6 to 12 weeks assessed by patient-reported outcomes.   "
28382|NCT02914197|"     To trial the provision of full information on the benefits and risks of mammography in women     that are eligible for breast screening. The knowledge many women have of mammography is not     reflective of the recent change in evidence; it is often missing information on     over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and     the benefits of breast screening. In addition, universal breast screening programs are biased     towards emphasizing screening. However, a mammogram is not a perfect test and there is no     right or wrong decision about whether to have a screening mammogram. It is an individual     woman's decision to make. To understand the effect of changing information to reflect the     potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled     trial of implementation of balanced information on mammography in family practice.   "
28383|NCT02914184|"     The purpose of this study is to evaluate the clinical consistency of three production lots of     the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus     (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to     the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity,     reactogenicity and safety when administered as a two-dose vaccination in healthy infants     starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the     study   "
28384|NCT02914171|"     The objective of this study is to determine the safety and feasibility of autologous     mononuclear cells (MNS) collected from bone marrow (BM) and using an add-on intramyocardial     delivery for individuals with Ebstein anomaly undergoing surgical intervention compared to     the control group undergoing the same surgical procedure without cell delivery. This add-on     procedure has the potential to foster a new strategy for individuals with congenital heart     disease.This is an open-label study of autologous MNC derived from bone marrow with a 2-year     follow-up to document 1) incidence and severity of adverse event and 2) monitor changes in     cardiac structure and function.   "
28385|NCT02914158|"     The objective of this study is to compare the curative effects in patients under the age of     35 with hormone receptor positive breast cancer and high recurrent risk factors including     large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus     aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the     differences of curative effects between different subtypes to provide direct evidence for     treatments of young breast cancer patients.   "
28386|NCT02914145|"     In line with the global and regional efforts towards malaria elimination, a five year program     was established to assist the NMCP in adopting targeted evidence-based elimination plans     through a 'learn by doing' strategy. The project aims to generate knowledge as data is     generated to inform the programmatic aspects of the elimination plan, most importantly how to     clear malaria parasites from the asymptomatic reservoir.   "
28387|NCT02914132|"     The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood     Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.   "
28433|NCT02913495|"     The purpose of this study is to evaluate the two suggested therapies for prevention of     recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and     intramuscular progesterone to determine whether vaginal progesterone is superior to     intramuscular progesterone in the prevention of recurrent preterm birth.   "
28389|NCT02914106|"     Despite several scientific and technological advances, there is no single neuroprotective     treatment that can reverse the brain damage after acute ischemic stroke (AIS). Neuroactive     steroids are cholesterol-derived hormones that have the ability to modulate the normal and     pathologic nervous system employing genomic and non genomic mechanisms.      In this work, we first investigated if AIS affects the plasma concentration of five     neuroactive steroids (cortisol, estradiol, progesterone, testosterone and 3-alpha     androstenediol glucuronide). Second, we studied if levels of circulating steroids associate     with neurological, cognitive and functional outcome in a cohort of 60 to 90 year-old male and     female patients with AIS.      For this purpose, we recruited patients who were hospitalized at the Emergency Room of the     Central Military Hospital within the first 24 hours after stroke onset. We designed two     experimental groups, each one composed of 30 control subjects and 30 AIS patients, both males     and females. The assessment of neurological deficit was performed with the NIHSS and the     tests used for the functional and cognitive status were: (1) modified Rankin Scale; (2) Photo     test and (3) abbreviated Pfeiffer's mental status questionnaire.   "
28390|NCT02914093|"     The overall objective of the study is to investigate the feasibility of home based     inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to     examine the relationship between inspiratory muscle strength and carbon dioxide level.   "
28391|NCT02914080|"     Social isolation and loneliness of the elderly have become major public health problems,     because of the deleterious consequences if not lethal they can generate.      Because of frequent resignation to these phenomena, support must be given to all means of     prevention to prevent or at least mitigate their impacts. It appears from the literature that     are isolated or living as they have adjustment difficulties which are linked to fragility. If     geriatric frailty have been defined to date in somatic and cognitive criteria, psychological     fragility criteria have been little discussed outside of psychiatric disorders (depression,     anxiety disorders in particular).      This study aims to test in the elderly in isolation psychological fragility questionnaire and     to study the statistical qualities and relations with socio-demographic variables,     environmental and other known vulnerabilities.   "
28439|NCT02913417|"     Reports to date show limited efficacy of immunotherapy for uveal melanoma. Recent     experimental and clinical evidence suggests synergy between radiation therapy and     immunotherapy. The investigators will explore this synergy with a feasibility study of 18     patients with uveal melanoma and hepatic metastases who will receive SirSpheres Yttrium-90     selective internal hepatic radiation followed by immunotherapy with the combination of     ipilimumab and nivolumab.   "
28392|NCT02914067|"     The investigators will focus on two cohorts of brain tumor patients aged, 4-18 years, to     answer two critical questions: 1) Can the investigators acquire high quality data relevant to     cognitive function during the peri-diagnostic period and, 2) can the investigators develop     predictive models for cognitive outcomes using serial examination of functional imaging and     cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible     for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior     fossa will be eligible for cohort 2. The rationale for of the focus on these patients is that     first, the posterior fossa is the most common location for pediatric brain tumors and     therefore this focus will impact the largest segment of this patient population. Second,     three tumors commonly occur here, medulloblastoma, ependymoma and pilocytic astrocytoma.     These are treated with surgery, radiation and chemotherapy (medulloblastoma), surgery and     radiation therapy (ependymoma) or surgery only (pilocytic astrocytoma). Thus, this focus will     provide a platform to analyze the impact that different tumor types and different standard     treatments have on cognitive dysfunction. Finally, the fact that all subjects will have     tumors of the same brain region will control for the effect that tumor location will have on     cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the     necessary data points to establish trajectories of cognitive development and recovery in this     population.   "
28393|NCT02914054|"     In this prospective, randomized, controlled clinical trial investigators' aim was to compare     the efficacy and the adverse effect of 3 therapy cycles of HD-DXM versus conventional     treatment with PDN for untreated adult patients with ITP. In this study standardized criteria     and definitions were used according to consensus international working group guideline for     ITPto compare clinical outcomes of the two corticosteroid treatment regimens and determine     the superior regimen as a first line strategy for new primary ITP in adults   "
28394|NCT02914041|"     Are the KypDisT and conventional C7WD are practical, valid, reliable, and effectiveness of     the tools to discriminate the functional ability impairments relating to kyphosis when     compare with gold standard (Cobb's method), and compare among physical therapy, VHS and     caregiver?   "
28395|NCT02914028|"     Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain.     Transversus abdominis plane block is a current intervention to support postoperative     analgesia, however it is recently in research area how to be applied in different surgical     areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane     block is not advised but has not been studied to be effective for postoperative analgesia in     inguinal herniography patients.      This study aims to research the effect of subcostal transversus abdominis plane block in     subacute postoperative pain after inguinal hernia repair   "
28396|NCT02914015|"     This prospective, randomized study, control study aims to compare the analgesic effect,     opioids consumption, quality of recovery, length of hospital stay and et al. between     unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled     analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal     incision.   "
28397|NCT02914002|"     Comer en Familia is a psychoeducational intervention in nutrition aimed to improve     nutritional status in families, particularly mothers and caregivers of children between the     ages of 5 and 13 years and their children through providing healthy cooking lessons in their     communities where the optimal preparation and use of local foods based on vegetables is     promoted at the same time the importance of cooking at home and eating as a family is     highlighted.   "
28434|NCT02913482|"     Open-label, multi-center clinical study is to assess the safety, tolerability,     pharmacokinetic, pharmacodynamics, and efficacy of RO7034067 in infants with Type 1 spinal     muscular atrophy (SMA). The study consists of two parts, an exploratory dose finding part     (Part 1) and a confirmatory part (Part 2) which will investigate RO7034067 for 24-months at     the dose selected in Part 1.   "
28462|NCT02913118|"     Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A Multicenter,     Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is that     combination therapy with Andrographolid Sulfonatein injection and antibacterial is     significantly better than antibacterial alone in achieving clinical stability among     hospitalized CAP patients.   "
28398|NCT02913989|"     Abstract: Tobacco dependence remains one of the primary health care concerns worldwide.     Attitude of healthcare professionals towards smoking is crucial for any long-term prevention     and smoking cessation program.      Objectives: Analyze smoking habits of medical doctors from a central hospital in Lisbon     (2014), comparing results between medical versus surgical specialities. Results were compared     with those obtained in 1999.      Design and setting: A voluntary and anonymous questionnaire was distributed to all physicians     for a period of 4 months. The questions included sociodemographic data, smoking habits     characterization, attitudes towards smoking, importance attribute to smoking cessation     programme in the hospital and knowledge of the 2008 country law.      Participants: All medical doctors working in the central hospital studied between 1/1/2014     and 30/6/2014 Outcome measures: The primary outcome measure was to characterize the smoking     habits of medical doctors. Secondary outcomes included comparison of results between surgical     and medical groups and with those obtain in a similar study in 1999.   "
28399|NCT02913976|"     The aim of this study is to demonstrate that the application of Kinesio Taping on a     myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an     increase of the cervical range of motion in patients diagnosed with cervical pain.   "
28400|NCT02913963|"     The aim of this study is to demonstrate that the application of Kinesio Taping on a     myofascial trigger point in the trapezius muscle able to cause a decrease of the trigger     point pain and an increase of the cervical range of motion in asymptomatic subjects   "
28401|NCT02913950|"     There is a need to develop a stool scale for baby's and toddlers who are not potty-trained     yet. The investigators try to get a uniform and approved Bristol stool scale for children who     ware diapers.   "
28402|NCT02913937|"     The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle     irrigation on post-operative pain and healing in patients with permanent posterior teeth with     apical periodontitis treated in a single visit.   "
28572|NCT02911870|"     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on     cardiac repolarisation in healthy male subjects   "
28403|NCT02913924|"     The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient     study,looking at the clinical treatment of cannabis use disorder.      The treatment study is a total of 12 weeks. There will be two options offered to participants     for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after     discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2)     patients who cannot complete the inpatient phase due to work or other obligations will     complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis     use disorder will be enrolled into either the inpatient/outpatient or only outpatient study.     This combined design will provide a comprehensive understanding of clonazepam's effects on     individuals with cannabis use disorder across a range of outcome measures while also testing     the medication's ability to prevent relapse in cannabis-abstinent patients.   "
28404|NCT02913911|"     -  Does the utility of external feedback in terms of goal-directed LLL approach during STS          training immediately improve functional ability relating to walking in ambulatory          patients with SCI?        -  Does the utility of LLL feedback improve functional ability relating to walking in          ambulatory patients with SCI after 2-week training?   "
28405|NCT02913898|"     This study will assess learning bias (the tendency to learn more from negative relative to     positive outcomes) at baseline in 3 groups of participants (currently depressed, previously     depressed and never depressed). It will then try to modify this bias using a simple     computerised training task completed at home daily for 2 weeks. Outcome measures include     symptoms of depression, cognitive measures (i.e. accuracy and reaction time during completion     of tasks), pupillometry measures and salivary cortisol.   "
28406|NCT02913885|"     The aim of this study is to compare the effect of color change between remineralizing agent     and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments   "
28407|NCT02913872|"     What are the capacity and training needs in general practice to implement routine spirometry     and eNO testing in children aged 5-16 years?      Asthma is the commonest long-term disease of childhood in the United Kingdom (UK).     Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been     reported from several European countries including the UK. This can result in poor symptom     control and increased risk of asthma related deaths.      It has been suggested that both under- and over- diagnosis of childhood asthma in general     practice could be improved by routinely using objective lung function testing for diagnosis     and monitoring.      The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements     - eNO) are already used routinely in UK hospitals, but are not usually available in general     practice where most children are cared for.      Why is it important? - Availability of these tests will help health professionals in general     practice to look after children with asthma better, and hopefully improve asthma control.      What will this study achieve? - Though it is believed that providing spirometry and eNO in     general practice would be beneficial, there is little data on how this can be achieved. This     study will employ both qualitative and quantitative measures in order to evaluate the     resources required to implement routine spirometry and eNO testing for children in primary     care; and to investigate the impact this would have on diagnosis in children with suspected     asthma.      How? - The investigators will work with general practices in and around Leicestershire, UK.     Firstly, to identify what the barriers are to implementing these tests, and secondly to train     the practices to perform and interpret spirometry and eNO independently in children.      Children with suspected or previously diagnosed asthma will be invited for review and lung     function testing. The investigators will record the time it takes to train general practices     to perform and interpret spirometry and eNO independently, and the additional clinic capacity     required to provide these tests.   "
28408|NCT02913859|"     PART I      Hormone therapy with or without definitive radiotherapy in metastatic prostate cancer      The goal of this clinical study PART I is to determine impact of radiotherapy treatment in     combination with standard androgen deprivation therapy comparing with androgen deprivation     therapy alone at controlling metastatic prostate cancer. The primary objective: to determine     disease progression free survival in man with metastatic (M1) prostate cancer (PC) undergoing     androgen deprivation therapy with or without definitive radiotherapy of the primary tumor.The     secondary objective: to determine disease progression (local, bone marrow, visceral) in men     with metastatic prostate cancer (M1PC) undergoing systemic therapy with/without definitive     radiotherapy of the primary tumor, to determine expression in number of genes analysed 8: 2     housekeeping genes; integrin subunits αv, β3, β5, α4β1 ; 3 EMT markers N-cadherin,     E-cadherin, vimentin before radiotherapy, after radiotherapy and at the time of the disease     progression , to determine plasma serotonin (5HT, 5 hydroxytryptamine). Subgroup analysis in     locally advanced prostate cancer (serves as a control group for integrins analysis): to     determine expression in number of genes analysed 8: 2 housekeeping genes; integrin subunits     αv, β3, β5, α4β1 ; 3 epithelial-mesenchymal transition (EMT) markers N-cadherin, E-cadherin,     vimentin before radiotherapy, after radiotherapy and at the time of the disease progression.      PART II      Identification of genetic determinants of disease progression and castrate resistance in     metastatic prostate cancer.      The goal of this clinical study PART II is to assess feasibility of genomic testing in the     multidisciplinary clinical management of metastatic prostate cancer, to gain insight in     specific genomic signature(s) of progressive metastatic prostate cancer in the natural course     of disease spanning from primary tumor to metastases, to test if 'treatment selection' and/or     'treatment adaptation' as means of evolutionary pressures represent the mechanistic models of     castrate resistance and ultimate treatment failure following course of androgen deprivation     therapy (ADT).   "
28409|NCT02913846|"     Denutrition is defined as a measurable decrease in functions and/or as change in the body     composition, associated with a worsening of the prognosis of the underlying medico-surgical     pathology. It is induced by a deficiency in energy, proteins or any other micro or     macronutrient and is the result of malnutrition, itself caused by a poor diet or a metabolic     disorder.      According to the National Nutrition and Health Plan for Belgium, denutrition is an     independent risk factor for the increase of complications, morbidity and mortality rates,     average length of hospitalisation and global medical care cost. It is necessary to invest in     the prevention of denutrition as the costs of preventive measures are lower than the cost of     treating a denutrished patient.      The Belgian financing system of hospitalisation days is based on the structure of the treated     pathologies, the age of the patient and the geriatric features of the patient. It encourages     all hospitals to lower the length of hospitalisation to the national average for all these     criteria. As a consequence, there is a mounting tendency to shorten the average length of     stay within the hospital.      The so-called 'Sp' hospital departments occupy a specific place within the organisation of     Health Services in Belgium. They are specialized in the treatment and rehabilitation of     patients with cardiopulmonary, neurological, locomotor, psycho-geriatric and chronic     diseases. These services act as an extension of acute services (continuity of acute     hospitalisation) but also as a first entry point for the medical care of patients with     various specific diseases (multiple sclerosis, psycho-geriatric disorders, chronic pulmonary     disorders...).      The financing of the Sp departments is, as opposed to the financing of other departments, not     linked to the patient length of stay. However, an increase in hospitalization duration     decreases the rate of admissions and the possibility to accept patients coming from acute     hospital units.      The aim of the study is to evaluate the influence of denutrition of patients hospitalized in     an Sp department on the length of revalidation stay, the associated costs and the patient's     functional autonomy.   "
28435|NCT02913469|"     Percutaneous coronary intervention(PCI) has become the first choice for STEMI     patients.According to the current guidelines,dual antiplatelet therapy with a P2Y12 receptor     inhibitor and aspirin ,and intravenous injection of morphine therapy for chest pain relief in     necessity play a pivotal role in the treatment of patients with ST elevation myocardial     infarction before primary percutaneous coronary intervention.And ticagrelor is recommended in     patients with ST segment elevation myocardial infarction undergoing PCI, with class IB     indication.Therefore coadministration of morphine and ticagrelor are commonplace.Currently,     some studies have found that morphine delayed and attenuated exposure to ticagrelor,but it is     not clear of the pathogenesis of it.Some researchers say that morphine results in a weaker     and retarded antiplatelet effect of ticagrelor in STEMI patients before PCI by inhibition of     gastrointestinal peristalsis and causing vomiting.The study is aimed at exploring whether     morphine delay and attenuate exposure to ticagrelor and its antiplatelet effect.In addition,     the trial will explore the possible mechanism which morphne delay and attenuate exposure to     ticagrelor in patients with ST-segment elevation myocardial infarction before PCI.   "
28410|NCT02913833|"     The financing of the Belgian hospitals is based on a system taking into account the length of     hospitalization of a given patient according to his/her pathology, his/her age and his/her     geriatric characteristics. This system encourages all hospital to lower the hospitalization     duration to the national average for these criteria. This results in better efficiency in the     management of hospitalizations but also means a swifter transfer to structures exempted from     this system such as revalidation units, nursing homes and psychiatric units. An assessment of     the differences in the medical practice, in terms of quality and outcomes of care, is     essential for any reform willing to reduce medical costs.      Pain management is part of the quality indicators within hospitals. Pain is defined by the     International Association for the Study of Pain as an unpleasant sensory and emotional     experience, associated to present or potential tissue damage, or described in terms of such a     damage. Several studies have showed that pain affects the quality of life and impacts the     daily activities. Acute or chronic pain can cause adverse symptoms such as sleep disturbance,     appetite loss, decreased concentration, mood changes and the disruption of familial, work and     social activities. Pain might also slow down revalidation processes. A study performed by     Aprile et al showed that pain negatively influenced the rehabilitation program of a quarter     of the patients having had a stroke. The functional recovery was slower and the costs were     higher.      The aim of this study is to determine if the systematic evaluation of the pain of a patient     hospitalized in a revalidation unit has an impact on his/her length of stay.   "
28411|NCT02913820|"     Changes in the ambient temperature (esp. warm to cold) as well as exercise are triggers for     vasospasms and plaque rupture. Weather data (temperature, precipitation in general as well as     snowfall and changes in atmospheric pressure) will be correlated with the incidence of     myocardial infarctions.   "
28412|NCT02913807|"     This study will test the accuracy of computerized custom mandibular reconstruction to     traditional methods of mandibular reconstruction using a vascularized osteocutaneous fibula     flap.   "
28413|NCT02913794|"     Fimasartan and Rosuvastatin for hypertension and dyslipidemia control   "
28414|NCT02913781|"     Cases which undergone ICSI before with failure of fertilization will do another ICSI cycle     with removal of the polar body just before the ICSI procedure and sperm injection at the site     of polar body removal. This study group will be evaluated with another group with the classic     ICSI procedure   "
28415|NCT02913768|"     Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is     associated with hypotension and bradycardia, which may be deleterious to both parturient and     baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an     important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in     intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of     ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following     subarachnoid block in parturients undergoing elective caesarean section.   "
28416|NCT02913755|"     Acquired Brain Injury (ABI) is damage to the brain caused by a head injury or illness/disease     such as stroke or aneurysm. ABI is often associated with poor awareness into ongoing symptoms     of damage to the brain, which can be cognitive, physical, and psychological. A     multi-disciplinary rehabilitation programme is recommended to help with such symptoms.     However, without self-awareness of difficulties, people with ABI can have poor motivation to     take part. The study aims to discover whether showing people a short 'preparatory' video     about ABI rehabilitation has an effect on self-awareness, and their motivation to take part     in rehabilitation offered to them.      The study also aims to investigate the feasibility of using the preparatory video on a larger     scale across inpatient ABI rehabilitation, by exploring whether staff find delivering the     video easy to incorporate into routine practice.      People invited to take part in the study will be recruited from a specialist inpatient brain     injury rehabilitation unit (BIRT).      People who are approached will be given information about what the study will involve, and     can choose not to take part.      Each participant will be asked to fill out a series of questionnaires. They will then be     supported by staff to watch a short video every two/three days, over four weeks. Half of the     participants will be shown the video right away, while the other half will wait two weeks, to     allow for comparisons between the groups. The video will aim to improve understanding of the     kinds of emotional and/or practical difficulties they may be experiencing, and will inform     participants about what rehabilitation might be like. After they have regularly watched the     video for four weeks both sets of participants will be asked to complete another set of     questionnaires, and the staff will be asked to complete an evaluation of how they found     delivering the video.   "
28426|NCT02913625|"     Locoregional anesthesia provides several advantages over general anesthesia in terms of     postoperative pain, decreased postoperative opioid needs and reduced recovery time for     patients undergoing orthopaedic surgery.      For upper limb surgery, the coracoid infraclavicular brachial plexus block is generally     preferred because of its simplicity and effectiveness but, needle visibility remains a     challenge because of the angle between the ultrasound beam and the needle.      The retroclavicular approach for brachial plexus anesthesia requires an angle between the     needle and the ultrasound beam that is less steep than the angle required to perform an     infraclavicular coracoid block. This approach has already been proven effective and safe in     the past.      The general objective is to provide a formal comparison between the retroclavicular approach     and coracoid infraclavicular approach for brachial plexus anaesthesia. This study will     delineate the differences between the two techniques.   "
28427|NCT02913612|"     Multi-center, double-masked randomized, efficacy, safety and pharmacokinetic (PK) study.   "
28463|NCT02913105|"     The purpose of the present study is to assess the effects of LMB763 with respect to safety,     tolerability, and on markers of liver inflammation in patients with NASH   "
28436|NCT02913456|"     This disease registry is a prospective, multicenter non-interventional study designed to     observe anti-cancer treatment regimens and clinical outcomes in participants with     HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months     old prior to registry enrollment.   "
28437|NCT02913443|"     This is a Phase I, open-label, multicenter study designed to assess the safety and     tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and     expansion study plans to determine the maximum tolerated dose and/or optimal biological dose     as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability,     pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.   "
28438|NCT02913430|"     To study progression free survival for treatment with Fulvestrant compared to treatment with     tamoxifen in Metastatic Breast Cancer.   "
28440|NCT02913404|"     The purpose of this study is to asses functional biomechanical outcomes and patient reported     outcome measures following single bundle ACL reconstruction (ACL-R) compared to single bundle     ACL reconstruction and extra articular tenodesis (ACL-R+EAT).   "
28417|NCT02913742|"     Mesial temporal lobe epilepsy (MTLE) is the most common cause of medication-resistant     epilepsy in adults, and MRI-guided laser interstitial thermal therapy is a new approach to     its surgical management; however, while LITT demonstrates fewer complications than     traditional surgical techniques, it generates lower rates of seizure freedom. During     traditional temporal lobectomy for MTLE, neurophysiologic intraoperative monitoring (NIOM)     can be used to better identify epileptogenic tissue and guide resection. Our study proposes     to investigate the utility of NIOM during LITT for MTLE. Subjects will be drawn from     refractory mesial temporal lobe epilepsy patients determined to be candidates for LITT.     During their LITT surgery, in addition to the placement of the stereotactic LITT probe,     subjects will receive a second smaller stereotactic electrode for intraoperative monitoring     of epileptic discharges before and after surgery. After surgery, at regularly scheduled     follow-ups, patients will receive the Quality of Life in Epilepsy questionnaire (QOLIE-31-P),     in addition to standard post-operative care. Endpoints will be surgical complications,     fractional decrement in epileptiform discharges from pre- to post-ablation recordings, and     surgical outcome at 6 months and one year. Analysis of severe complications will be expressed     as a simple complication rate, for overall complications, severe complications, and     hemorrhagic complications in specific. The relationship between fractional discharge     decrement and outcome will be assessed by regression analysis. Risks of the study will stem     from the placement of the stereotactic electrode for intraoperative monitoring, which     represents a small incremental risk beyond typical LITT for MTLE.   "
28418|NCT02913729|"     Most of the local recurrences (LR) found after breast-conserving therapy are within or close     to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving     surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC     boost trial, however, 29% of all LR were found outside the area of the original tumor. Still,     a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local     recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the     breast. This led to the concept of partial breast irradiation. With accelerated partial     breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a     higher dose per fraction compared to whole breast irradiation (WBI), which is favorable     considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.   "
28419|NCT02913716|"     This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and     metabolite identification of defactinib.   "
28420|NCT02913703|"     Background and Significance: The peptide hormone ghrelin drives hunger and feeding behavior,     making it a focus of obesity research. Released mainly by the stomach and proximal small     intestine, ghrelin peaks prior to meals, potentially priming the gut for anticipated     nutrients. After eating, ghrelin abruptly declines, with levels varying 2- to 3-fold between     the fasted and fed states. Interestingly, in obesity and type 2 diabetes (T2D), this pattern     is disrupted. Individuals with these disorders have chronically suppressed ghrelin levels and     little variation before and after meals.      Although ghrelin's preprandial rise and postprandial fall is a well-established phenomenon,     its role in regulating glucose metabolism is unclear. In mice, increasing preprandial ghrelin     levels improves glucose tolerance through enhanced glucagon-like peptide-1 (GLP-1) secretion.     Ghrelin also stimulates GLP-1 secretion from mouse and human intestinal L-cells in vitro.     These findings suggest enhanced postprandial GLP-1 as a novel role for the preprandial     ghrelin surge. A ghrelin-incretin enteroendocrine axis could also explain the poor     postprandial GLP-1 secretion and glucose tolerance in subjects with T2D, given their     preprandial hypoghrelinemia.      The investigators' preliminary data demonstrate that in humans, increasing circulating     ghrelin to a supraphysiologic range worsened glucose tolerance, despite increased GLP-1     secretion. The discrepancy between these findings and the ones from rodents could be due to     difference in study design and/or species. For example, the investigators' study used a     continuous ghrelin infusion, which resulted in elevated levels of ghrelin pre- and     postprandially. Elevated postprandial ghrelin likely mitigated the positive effects of     increased GLP-1 secretion by raising levels of glucagon and other counter-regulatory     hormones.      This study seeks to delineate the interactions between ghrelin and GLP-1 in the regulation of     glucose tolerance, beta-cell function, and insulin sensitivity. The investigators hypothesize     that increased preprandial ghrelin will enhance GLP-1 secretion and consequently improve     glucose tolerance in healthy subjects and those with T2D. Confirmation of these hypotheses     would advance the investigators understanding of the control of glucose homeostasis and have     important clinical and therapeutic implications. Modulating ghrelin levels may provide a     novel therapeutic strategy to improve glucose tolerance in individuals with T2D, which     affects an estimated 350 million people worldwide.   "
28421|NCT02913690|"     This study aims to determine if tocotrienol rich fraction (TRF) supplementation can improve     markers of inflammation, oxidative stress and blood lipids in Malaysian hemodialysis (HD)     patients.   "
28422|NCT02913677|"     Recent studies showed the benefits of early initiation and advancement enteral feeds with     daily increments in preterm infants on decreasing invasive infections and early achievement     of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants     are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of     developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and     the rate of increments of enteral feeds are usually uncertain issues for neonatologists.   "
28423|NCT02913664|"     Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's     disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with     lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects     of aerobic exercise training and intensive vascular risk reduction on cognitive performance     in older adults who have high risk for AD.   "
28424|NCT02913651|"     Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy     affecting the sympathetic function. In this study the investigators analyzed whether altered     diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free     patients diagnosed with idiopathic hypersomnia and age-matched controls were included.     Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to     spontaneous arousal are analyzed.   "
28425|NCT02913638|"     The purpose of this clinical study which is to evaluate the benefits of lactation support     intervention, in conjunction with maternal nutritional supplementation during the last     trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast     feeding practices (primary objective), and 2) cognitive development in children within 28     months 16 days - 32 months 30 days (secondary objective).   "
28428|NCT02913573|"     Patients undergoing total mastectomy with immediate breast reconstruction with a tissue     expander or implant under general anesthesia will be randomly assigned to the addition of a     pectoral nerve block or no regional block. Post-operative pain, nausea/vomiting scores will     be assessed.   "
28429|NCT02913547|"     The objective of the study is to evaluate the safety, efficacy and usage compliance of the     home-use device Silk'n HST for self-treatment of periorbital wrinkles and skin laxity and     improvement of skin appearance.   "
28441|NCT02913391|"     Heart surgery can evolve with complications in the postoperative phase, mainly of a     respiratory nature, atelectasis and hypoxemia being the main pulmonary dysfunctions. They can     lead to increased length of hospitalization, being the major cause of morbidity and mortality     in the postoperative phase of heart surgery. In order to prevent or reduce such complications     noninvasive ventilation (NIV) has been used in the postoperative period in a prophylactic and     therapeutic manner. The use of positive end expiratory pressure (PEEP) is already widely     spread in intensive Care Unit (ICU), being used in patients under mechanical ventilation     (MV), NIV and exercises with intermittent positive pressure and has huge scientific     publication reporting its benefits for the pulmonary function. The alveolar recruitment     maneuver (ARM) consists of sustained increase of pressure in the airway using PEEP in     individuals with hypoxemia, in order to minimize the deleterious effects arising from     alveolar collapse, providing a more homogeneous ventilation of the pulmonary parenchyma     increasing the pulmonary area available for gas exchange and, consequently, arterial     oxygenation. In recent years the increase in the application of PEEP in cardiopathic patients     under MV has shown great benefits and the use of NIV to improve oxygenation by the reversal     of atelectasis is already widely used and recommended in hospital routine. Despite NIV being     used in great proportion, the relevant literature is poor in showing studies with NIV and ARM     associated in heart surgery. Therefore, the objectives of this study are to evaluate if the     use of NIV associated with ARM improves oxygenation in patients in postoperative     revascularization of the myocardium related to usual use without ARM, and if it can be     applied in a safe manner.   "
28442|NCT02913378|"     This is a randomized trial comparing conservative with surgical treatment (with open     reduction and locking plate fixation) for proximal humeral fractures in patients aged more     than 60 years.   "
28443|NCT02913365|"     The study consist of a retrospective analysis of the etiologies, investigations and outcomes     of patients presenting between 2005 to 2010 with hemoptysis in a North-American Tertiary     center.   "
28444|NCT02913352|"     Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette (iliac     bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.   "
28445|NCT02913339|"     Cardiovascular disease (CVD) accounts for approximately one-third of Argentina's deaths.     Despite the availability of management and treatment for CVD which is offered to the     uninsured population at government primary care clinics (PCCs), the rates at which those at     risk are screened, identified and referred to the clinics are very low. This study will     determine if providing CHWs with an mHealth application using an integrated, inexpensive and     validated screening tool on cell phones for screening in the community which is linked with     the PCC scheduling system wirelessly allowing the CHWs to make appointments at the time they     identify high-risk individuals, will increase the number of referral and follow-up visits     that patients attend at the PCCs.   "
28446|NCT02913326|"     This is a multi-center, prospective, international, randomized (1:1), open-label study with     two parallel groups. This phase III study is planned to investigate the efficacy and safety     of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of     major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with     blinded endpoint adjudication.   "
28447|NCT02913313|"     The purpose of this study is to evaluate the safety and effectiveness of experimental     medication BMS-986207 by itself and in combination with Nivolumab in solid cancers that are     advanced or have spread.   "
28464|NCT02913092|"     This study will evaluate the role of using electronic sensors for asthma inhaler devices in     monitoring medication adherence and asthma control   "
28448|NCT02913300|"     Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly     performed for diagnosis of mediastinal pathologies. The procedure can either be performed     under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients     tolerate the procedure well although cough is often reported as a distressing symptom.     Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no     literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS     TBNA. This study would help to determine whether 1% lignocaine is as effective as 2%     lignocaine for airway anaesthesia during EBUS-TBNA.   "
28449|NCT02913287|"     The aim of the overall project is to investigate the potential of a combination of     commercially available nutraceuticals produced by Marigot Ltd (natural seawater derived     mineral-rich AquaminMG and seaweed-derived mineral-rich food supplement AquaminTM (FDA GRAS     000028) isolated from Lithothamnion species), as safe and effective supplements to promote     cognition in the aged brain.   "
28450|NCT02913274|"     Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the     leading cause of hospitalisation (20%) and morbidity in chronic haemodialysis patients     incurring significant related costs estimated at over one billion dollars in the USA.      Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as     this is the least invasive procedure, the alternative being revision surgery. Angioplasty     uses an inflatable balloon of various diameters. Different types of angioplasty balloons may     be needed to break fibrous venous stenosis, in particular high-pressure balloons (20 atm) or     cutting balloons. These angioplasty procedures which are often painful during dilation have a     high technical success rate (90-97%) but a poor 1-year patency rate, varying between 26 and     64% depending on the team and a mean rate estimated at 40% for the studies including the     larger number of patients, some of whom requiring several procedures.      These invasive repeated procedures impair the quality of life of these patients with     end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for     whom vascular access patency is vital.      Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation     processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis     access is the key factor in development of a new stenosis and hence a vicious circle of     stenosis-angioplasty.      For the past few years, angioplasty balloons delivering anticancer drugs (Paclitaxel,     Sirolimus, Everolimus) have been developed. These drugs, generally used in high doses for     cancer chemotherapy, are released in small doses on the medical angioplasty devices. During     inflation, the local release of the anticancer (antimitotic) molecule through the different     layers of the vessel wall (Paclitaxel is lipophilic and hydrophobic) confers local     antiproliferative action without the systemic toxic effects associated with high-dose     chemotherapy.      These medical devices have demonstrated their efficacy in terms of increase in primary and     secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal     or sub-popliteal artery angioplasty (treatment of angina or lower limb arteriopathy).      These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being     indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has     proven their medical effectiveness, and in particular their contribution in terms of patency     rate improvement. However, studies on animal models show significant results regarding     efficacy against neointimal hyperplasia and the first single-centre clinical trials on a     small sample size appear promising.      The key assessment criterion is primary patency of the dilated stenosis at one year defined     by patients efficaciously dialysed at one year without re-intervention on the dilated lesion     after initial angioplasty. The delay of occurrence of dilation will be considered (censored     criteria). Patients that will be non-evaluable for the primary endpoint (death, lost to     follow-up…) will be censored at the date of the latest news.   "
28451|NCT02913261|"     To evaluate the safety and efficacy of ruxolitinib compared to Best Available Therapy in     patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem     cell transplantation   "
28452|NCT02913248|"     The purpose of the present investigation is to record and compare bacterial compositions in     subgingival plaque samples and saliva samples in subjects receiving periodontal treatment.     The hypothesis is that the composition of the salivary microbiota might reflect local     bacterial alterations in relation to periodontal treatment.   "
28453|NCT02913235|"     The purpose of the present investigation is to record and compare bacterial compositions in     supragingival plaque samples and saliva samples in subjects discontinuing regular oral     hygiene for 10 days. The hypothesis is that the composition of the salivary microbiota might     reflect local bacterial alterations in relation to discontinuation of oral hygiene.   "
28454|NCT02913222|"     Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young     adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of PAHD is     needed to improve function in the young adult and prevent or delay the onset of hip OA,     however evidence related to treatment of PAHD is limited. This research will provide the     foundation for a future clinical trial to assess the efficacy of movement pattern training,     an innovative rehabilitation approach for the treatment of PAHD.   "
28469|NCT02913027|"     The purpose of this study is to investigate patients self-reported comfort levels during each     section of the pelvic exam.   "
33049|NCT02853175|"     In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic     Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic     fibrosis.   "
28455|NCT02913209|"     Fatigue is consistently rated as the top symptomatic complaint for individuals with multiple     sclerosis (MS). Currently, the MS Fatigue Impact Scale (MFIS), a subsection of the Multiple     Sclerosis Quality of Life (MSQoL), is the clinical standard used by neurologists for     monitoring and tracking fatigue in individuals with MS. However, fatigue is multidimensional     phenomenon and subjective measures have had poor or limited relationships with functional     status. While previous study has focused on contributing factors to fatigue such as sleep     disorders and diminished cortical excitability, this line of inquiry has neglected the role     of muscle structure and function on fatigue in every day functional tasks. An alternative     approach is to assess quantitative fatigue using anaerobic testing methods. However, more     knowledge is needed to understand the role that quantitative fatigue plays in self-reported     fatigue measures and function of daily activities. Our purpose is to determine the     association between quantitative fatigue tests with performance-based measures of mobility     and self-reported health-related quality of life. Our secondary goal is to understand how the     intrinsic properties of muscle tissue influence muscle performance in Veterans with MS.   "
28456|NCT02913196|"     This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate,     docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer     (mCRPC).      This study is designed to determine the dose that apalutamide can be administered safely in     combination with abiraterone acetate, docetaxel and prednisone.   "
28457|NCT02913183|"     Stroke is one of the main severe disease of public health importance. Recent studies showed     that old age is one of the most important factors in influencing the outcome of patients with     acute stroke, and the young plasma can reverse age-related brain impairments in mice.     Therefore, this pilot study aims to investigate whether young plasma is effective in     alleviating brain injury and neurologic deficits induced by acute stroke in patients.   "
28458|NCT02913170|"     The aim of this study is to examine the effects of nattokinase supplementation on hemostatic     factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time,     prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid     profiles were measured at baseline and at 8-week follow-up.   "
28459|NCT02913157|"     The purpose of this clinical trial is to determine if HCQ in a dose of 400mg daily can     prevent worsening of walking ability in people PPMS. The number of participants in this study     will be 35. A maximum of 42 people with PPMS will be included. The trial is funded through a     private donation to the Hotchkiss Brain Institute MS Translational Clinical Trials Research     Program and the University of Calgary. There is no sponsorship from the pharmaceutical     industry.   "
28460|NCT02913144|"     OBJECTIVES: To investigate the incidence of cardiovascular events as well as progression of     coronary artery calcium (CAC) in healthy middle-aged subjects over a period of 7 years, and     the relation to traditional as well as new cardiovascular risk factors.      METHODS: The Danrisk cohort was established in 2009-2010 based on random retrieval from the     Danish national civil registry (N=1825). Initially, distribution of gender, area of residence     and year of birth (1949 or 1959) were equal among the 4 involved centres (OUH, Svendborg,     Vejle and Esbjerg). A total of 1257 subjects (69%) accepted the invitation to undergo     cardiovascular risk evaluation including non-contrast enhanced cardiac CT-scan for CAC     estimation, and a total of 1227 subjects were found free of cardiovascular disease (CVD) and     diabetes (DM), and was included in the study back then.      In 2014-2015 the DanRisk cohort was invited to a 5 year follow-up examination. The     investigators examined a total of 1031 subjects (82%) in the investigators 4 regional     centres. The follow-up examination included general health evaluation and estimation of CAC     by non-contrast enhanced cardiac CT-scan. Information of death, cardiovascular events and     medication usage was obtained from the Danish national patient register, the Danish register     of causes of death and the Danish national database of reimbursed prescriptions in 2016.   "
28465|NCT02913079|"     Context and Rationale: Uninterrupted sitting is associated with increased risk of diabetes,     heart disease, and death, even among people who are physically active. These relationships     are likely due to increases in post-meal blood sugar observed when people sit for long     periods (e.g. > 1 hour) without interruption. In contrast to sitting, standing results in     large reductions in post-meal blood sugar levels. Our group has recently shown that sit-stand     desks result in large (e.g. 2.5 hour/day) reductions in occupational sitting time. Taken     together, these findings suggest that sit-stand desks may help to reduce post-meal blood     sugar levels. However, this has yet to be examined in the field. Theoretical Approach and     Objectives: The objective of this randomized crossover study is to determine whether people     have lower blood sugar when using a sit-stand desk, in comparison to a desk that can only be     used while sitting. Methods and Procedures: Sixteen participants will be asked to wear a     continuous glucose monitor to measure their blood sugar levels during 2 separate conditions.     During one condition, they will be asked to use a sit-stand desk to sit and/or stand as much     as they like during 1 workday. During the other condition, they will be asked to work at a     seated desk for 1 workday. Participants will be provided with identical meals to eat during     each of the two conditions. We hypothesize that participants will have lower blood sugar     levels on the day when they use the sit-stand desk, in comparison to the day using a     traditional seated desk. Significance and Future Use: If our results support this hypothesis,     this would suggest that sit-stand desks may be a useful way to reduce blood sugar levels in     people at risk for diabetes. This could also lead to larger population-based interventions     studying the health impact of sit-stand desks.   "
28466|NCT02913066|"     Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided     into 2 groups randomly:      Experimental group: radiotherapy combined with S-1 chemotherapy.      Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.   "
28467|NCT02913053|"     Exercise interventions to prevent dementia and delay cognitive decline have gained     considerable attention in recent years. Human and animal studies have demonstrated that     regular physical activity targets brain function by increasing cognitive reserve. Although     initial studies indicate enhanced cognitive performance in patients with mild cognitive     impairment (MCI) following an exercise intervention, little is known about the effect of an     extensive, controlled and regular exercise regimen on the neuropathology of patients with     MCI.      The aim of this study is to compare a 12- month aerobic exercise programme versus a     stretching and toning (non-aerobic) programme versus a control group on the progression of     cognitive decline in MCI.      It is hypothesized that MCI-related decreases in cognitive and psychomotor functioning will     show less progression or even be improved after a one-year aerobic exercise intervention     compared to a group of patients undergoing stretching and toning exercise as well as to a     control group provided with no intervention.   "
28468|NCT02913040|"     In this multi-centre randomized controlled trial the investigators compare the effect on     dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal     Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe     dyspnoea.   "
28470|NCT02913014|"     This study is being done to find out if patients taking Anti Arrhythmia Drugs (AAD's) after     cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti-     Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study     will also look at the side effects of the AAD's.   "
28471|NCT02913001|"     This randomized controlled trial will examine changes in some hormonal markers associated     with acne among adults with moderate/severe acne randomized to a low glycemic index and     glycemic load diet or usual eating plan for two weeks.   "
28472|NCT02912988|"     In-vitro fertilization (IVF) is the treatment of choice for couples with prolonged     infertility. The treatment usually involves hormonal stimulation of the ovaries by follicle     stimulating hormone (FSH), followed by surgical removal of eggs which are then mixed with     sperm in the laboratory to create embryos. The success rates of IVF treatment remain     unsatisfactory and are no longer increasing. One of the reasons is an adverse effect of high     serum estradiol levels following FSH stimulation on the lining of the uterus.      Letrozole is a drug used in the prevention of recurrence of breast cancer because of its     action to reduce the intra-ovarian aromatization of androgens to estrogens. It is now     increasingly used for ovulation induction and is as safe as clomiphene citrate. Use of     letrozole during standard ovarian stimulation for IVF producing adequate numbers of oocytes     with physiological levels of estradiol may increase the present success rate of standard IVF     treatment.      The aim of this randomized study is to compare the live birth rate of FSH alone versus     combined FSH and letrozole used for ovarian stimulation in IVF treatment.   "
28473|NCT02912975|"     A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and     residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study     will be conducted with a semi-crossover design using self-rated pain and function as the main     result variables.   "
28474|NCT02912962|"     Fetal alcohol spectrum disorder (FASD) describes a collection of physical, mental, and     behavioral disabilities that result from prenatal alcohol exposure (PAE). Individuals with     FASD often struggle with self-regulation, or the ability to control thoughts, emotions and     actions, which can lead to many long-term problematic life circumstances.      This study aims to improve self-regulation abilities in adolescents, aged 11-17, with FASD     using a targeted intervention. Researchers adapted the Alert Program®, a developed     intervention targeting self-regulation in children, to be appropriate for an adolescent FASD     population. Participants are split into two groups: an FASD intervention group, and an FASD     waitlist group. These groups are compared on a variety of measures. These measures include     cognitive measures (executive functioning, response conflict, inhibitory control, etc),     behavioural measures (self-regulation, adaptive behaviour, etc), and physiological measures     (cortisol and sleep). The FASD intervention group will be tested at baseline and once after     the intervention, and lastly after an approximately 12-week wait following the intervention.     The FASD waitlist group will be tested at baseline, after a three month wait period, and     again after receiving the intervention.      The investigators expect that the Alert program® will lead to significant improvements in     participant's self-regulation abilities as evidenced by cognitive, behavioural, and     physiological changes. Improving self-regulation in adolescents with FASD will reduce the     high level of adverse outcomes experienced by adolescents with FASD, and help them have a     successful transition into adulthood.   "
28475|NCT02912949|"     This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent     study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of     MCLA-128   "
28476|NCT02912936|"     The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics     of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients     with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this     intervention will also be explored.   "
28477|NCT02912923|"     The project targets stroke survivors to investigate the effect of augmented feedback (using     robotic force cues and visual feedback) and rewards (game scores), on their upper limb     reaching patterns and trunk compensatory movements   "
28478|NCT02912910|"     To study central blood pressure changes caused by commonly used high blood pressure     medications in pregnancy.   "
28479|NCT02912897|"     The etiologic mechanisms involved in multiple sclerosis (MS) are not yet fully understood.     Indeed MS is a multifactorial disease involving genetic and environmental factors and     Epstein-Barr-Virus (EBV) could be one of these factors. However the link between EBV     infection and the immunological mechanisms underlying MS is not clear. Robust     sero-epidemiological evidences support an association between EBV infection and MS, and     immunological data suggest an altered/deficient immune response against this virus. In     healthy individuals EBV produces a persistent infection that is tightly controlled by the     immune system. In patients with MS, cellular and humoral immune studies demonstrate an     altered response against the virus with a T-cell abnormal reactivity against the EBV-infected     autologous B-cells, elevated humoral immune response to Epstein Barr Nuclear Antigen-1, and     in the case of children, an increased EBV shedding, demonstrating frequent EBV reactivations.     Thus, it has been proposed, that patients with MS present a partially inefficient control of     the EBV infection. Some experimental data support the hypothesis suggesting that the presence     of autoreactive EBV-B cells in the meninges of patients, probably due to an insufficient     clearance of these cells by the immune system, lead to the infiltration of autoreactive T     cells. Another hypothesis also suggests a deficient control of the virus, in that case during     the inactive phase of the disease. Together, the above data and hypotheses lead to the notion     that an immune intervention capable of restoring the host-EBV balance could be beneficial to     MS patients In this project, we will assess the feasibility and safety of autologous transfer     of several amounts of CD8 T cells directed against autologous EBV transformed B cell lines,     in order to finally restore an efficient control of EBV in MS patients. The main objective of     the project is to test the feasibility and safety of the process, while efficacy parameters     will be also assessed in secondary objectives.   "
28499|NCT02912637|"     Chronic lung diseases show a gradual onset of irreversible lung damage which can lead to     severe breathing problems and/or respiratory failure. Imaging is central to guiding     treatment; however, current techniques are either inaccurate or involve exposure to     radiation. Recent developments in lung magnetic resonance imaging (MRI) provide promise as a     radiation-free alternative. However, conventional MRI cannot directly show changes in     distribution of inhaled air or absorption of gas which are important signs of early lung     disease. Recently MRI imaging of the inhaled gas contrast agent Xenon has been developed     which can provide this important information. This study aims to determine how Xenon MRI can     help determine air flow distribution and gas uptake in the lungs. The investigators will also     be able to compare the information from patients with that from healthy volunteers. This     should give insight into the processes involved in chronic lung diseases and help evaluate     disease extent in patients.   "
28500|NCT02912624|"     Circulatory shock is a condition of generalized inadequate blood flow through the body,     leading to insufficient tissue perfusion and inadequate delivery of oxygen and other     nutrients, to the extent that tissues are damaged. Four basic mechanisms of circulatory     failure are distinguished, caused by a scale of underlying illnesses: distributive,     hypovolemic, obstructive and cardiogenic shock. The last three types are characterized by a     low cardiac output and hypovolemia. Distributive shock is characterized by peripheral     circulation failure, with a low systemic vascular resistance, a disturbed microcirculation     and a high cardiac output. Frequently, these forms overlap.      Shock is a common problem in the intensive care unit (ICU) as it affects about one third of     the patients. Septic shock appears to be the most common type, followed by cardiogenic and     hypovolemic shock. The diagnosis of shock is based on clinical examination with use of     well-known circulatory parameters such as blood pressure and heart rate; biochemical     parameters such as lactate and direct (semi-)invasive measurement of cardiac output and other     variables.      Since cardiac output is an important determinant of oxygen delivery, many different methods     of measuring cardiac output have been suggested. These methods range from non-invasive to     invasive measurements with central lining. The most invasive method, the pulmonary artery     catheter (PAC) has long been considered the optimal form of monitoring cardiac output by     using thermodilution. However, this technique is associated with adverse events, such as     bleeding, and there is no clear evidence of improved outcome. Therefore, numerous other     techniques have been proposed, ranging from systems that use the dilution technique but only     require central venous and peripheral artery lines; to less invasive tools that estimate     cardiac output based on the arterial pressure waveform; and to non-invasive echocardiography.      Despite technical advances, much remains unknown about the value of conventionally used     hemodynamic parameters for estimating cardiac output. A distinction between macro- and     microcirculatory parameters can be made. Commonly used macro-circulatory parameters are heart     rate, systolic and diastolic blood pressure, mean arterial pressure and central venous     pressure. Lactate is used as a proxy for microcirculatory status. Over the years several     other measurements have been suggested to improve insight in the hemodynamics of a certain     patient or a group of patients. Skin temperature, capillary refill, mottling score and     urinary output are used for hemodynamic assessment of the peripheral circulation and tissue     perfusion. Most of these parameters have not been evaluated in a large prospective study and     especially a combination of all these parameters has not directly been correlated to cardiac     output.      More knowledge on the predictive value of all hemodynamic parameters in estimating cardiac     output could assist physicians in earlier detection of impaired hemodynamics without the need     for invasive or advanced methods. In this study the investigators aim to evaluate all     hemodynamic parameters in a large unselected population of critically ill patients and to     correlate them to cardiac output.      Purpose:      The purpose of this study is to create an infrastructure for a registry flexible to     incorporate temporarily added specific research questions on the outcome of critically ill     patients.   "
28480|NCT02912884|"     Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential     Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of     both venous and arterial thrombosis. Thrombotic complications are the main determinant of     morbidity and in a less extend mortality.      Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a     hypercoagulable state. However, previous evidence suggests that global coagulation tests such     as thrombin generation or thromboelastometry are able to detect signs of procoagulant     imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties     (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an     hypercoagulable state.      Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic     events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for     PV and are under investigations on clinical trial for ET. It is currently unknown if     treatments that were used for ET and PV, and especially JAKi are able to modify the     hypercoagulable state that is observed in those diseases, and if there is difference between     drugs.      To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to     evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.   "
28481|NCT02912871|"     Based on published animal and human studies, ExAblate Transcranial subthalamotomy can be as     safe and as effective as any of the surgical treatments within the currently accepted     standard of care including radiofrequency lesioning and Deep Brain Stimulation (DBS). A     unilateral lesion of the subthalamic nucleus has shown reduction of contralateral motor     symptoms in Parkinson's disease (PD). Using ExAblate Transcranial Magnetic Resonance guided     High Intensity Focused Ultrasound (MRgHIFU) to create the subthalamotomy has several     potential advantages over current therapies including the fact that transcranial lesioning     can be performed in a precise manner with simultaneous as well as continuous clinical and     radiographic monitoring. If the potential of ExAblate Transcranial subthalamotomy can be     realized, it could supplant radiofrequency and radiosurgery techniques and provide a viable     alternative procedure for subjects considering DBS.   "
28482|NCT02912858|"     Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant     burden on the patient, their family, and healthcare resources. Treating VLU can present a     significant challenge to clinicians, who currently have a limited range of treatments at     their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation     at rest. In addition to the aforementioned, intermittent pneumatic compression has also been     utilised1. When applied to the leg or foot intermittent pneumatic compression (IPC) devices     intermittently inflate and deflate to increase venous return. These devices can be     uncomfortable to wear, and compliance can be inhibited because of size, weight and external     power source that limit the patient's mobility. In patients who cannot walk, or in those who     are unable to tolerate compression bandaging, ulcers may deteriorate and never heal.     Accordingly, there is a need for novel, alternative devices or strategies that can be used to     complement or replace compression bandage therapy.   "
28483|NCT02912845|"     The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies     Immunoglobulin) in children ages 0 months to <17 years, when administered as part of     post-Rabies Exposure Prophylaxis (PEP).   "
28484|NCT02912832|"     The purpose of this study will be to determine the performance characteristics of TBDx with     culture as a gold standard. In addition, the investigators will assess the laboratory     technicians' appraisal and technical suitability of the TBDx system.   "
28485|NCT02912819|"     General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The     open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry     hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse     during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening     and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized     patients.      Investigators hypothesized that the SpO2 breathing air can personalize the open-lung     approach.   "
28486|NCT02912806|"     Evolving reimbursement policies are driving health systems to improve quality and efficiency.     Transitioning to an electronic health record (EHR) provided Dartmouth-Hitchcock Medical     Center (DHMC) an opportunity to redesign staff roles and care path for Total Knee Replacement     (TKR). The organization implemented a coordinated team-based care delivery model that     integrated real-time measurement of: (1) compliance with trusted guidelines, (2) process of     Shared Decision-Making (SdM), and (3) use of Patient-Reported Outcomes (PROs). The     investigators present the implementation protocol and data.   "
28487|NCT02912793|"     This research study is being conducted to find out whether Trappsol® Cyclo™, an experimental     treatment for people with Niemann-Pick disease Type C1 (NPC-1) is safe at 3 different dose     levels and what effects it has on people who have this condition. NPC-1 is caused by a defect     in a protein which is important for the transport of fatty substances like cholesterol out of     cells. Without this protein, fats build up in the cells ultimately leading to organ damage.     The way in which this experimental treatment works is not fully understood but laboratory     experiments have shown that it can potentially remove cholesterol build up from the cells in     people who have NPC-1. Approximately 12 patients will be asked to take part in this research     study for up to 56 weeks in total. recruitment is expected to take 9 months.Patients who take     part will receive treatment by an intravenous infusion every two weeks. The study will look     at what the body does to the drug as well as what the drug does to the body by taking and     examining blood and urine samples. Samples of Cerebrospinal fluid (CSF) are also taken by     lumbar puncture during and following the first treatment dose. Patients will also have their     hearing tested, be asked questions by their doctor as well completing questionnaires to help     assess any changes in their condition during treatment. Optional assessments patients can     choose to take part in include liver biopsies, additional lumbar punctures for     CSF.examinations to see if the drug is affecting these. This study is being sponsored and     funded by CTD holdings INC. It is planned to be run in the UK, Italy, and Sweden.   "
28533|NCT02912377|"     Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to     assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim     (B12019) and the reference product Neulasta® in healthy subjects   "
28534|NCT02912364|"     Double-blind, randomized, two period crossover comparison of the cognitive and behavioral     effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.   "
28488|NCT02912780|"     The advancement in life-saving technologies and clinical expertise in the care of extremely     premature infants, have resulted in the development of large neonatal intensive care units     (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to     smaller care units with specific patient population and clinical team providers will be     essential to maintain optimal teamwork, quality of care and patient outcome.      Despite the growing knowledge around the need for reconstruction of large NICUs to smaller     units of care, there is no evidence regarding the safety and efficacy of microsystem model of     care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we planned     a change from standard model of care to the microsystem model of care and therefore we aimed     to prospectively assess the effect of this organizational change on the variable aspects of     health care.      A working group met weekly to formulate the implementation planning, to review the adaptation     and adjustment process and to ascertain the quality of implementation following the     initiation of the microsystem model.      The study was retrospectively registered.   "
28489|NCT02912767|"     The investigators are interested in understanding how the patient has been doing since their     surgery for endometrial cancer and if they are experiencing any symptoms related to     lymphedema (swelling) in the your lower body. The investigators hope that information from     the patient and others will help them improve care for women treated for endometrial cancer.   "
28490|NCT02912754|"     This study involves adding the kinase inhibitor Ruxolitinib to Ibrutinib to treat Chronic     Lymphocytic Leukemia (CLL).   "
28491|NCT02912741|"     The aim of this study is to evaluate the addition of new technology of resin modified     glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot     lesions; both applies into the same patient's mouth; to reveal which material will have more     clinical satisfactory performance inside the oral cavity and to overcome the high expensive     cost in treating such clinical cases   "
28492|NCT02912728|"     The primary objective of this study is to compare the efficacy and safety of CGM alone and     CGM combined with a family behavioral intervention with a control group using home blood     glucose monitoring (BGM) alone.   "
28493|NCT02912715|"     Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1,     6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented     re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery     (PPA) in a Chinese patient population.   "
28494|NCT02912702|"     This study aimed to investigate the efficacy and safety of Pegaspargase together with     liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial     treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.   "
28495|NCT02912689|"     Number of Patients:      Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) =     20      Inclusion criteria      a) Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory     failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no     indication for invasive mechanical ventilation.      Exclusion criteria        1. Patient with any contra-indication for insertion of nasogastric tube (like recent          gastrointestinal bleeding in previous 30 days, esophageal varices)        2. Patient with any contraindication of noninvasive ventilation (such as hemodynamic          instability, active gastrointestinal bleed etc)        3. Patients with a known neuromuscular, central or peripheral nervous system disorder.        4. Patient not willing to give consent.      Control(s): Patients receiving pressure support ventilation (NIV-PSV) will act as control      Study design: Randomized interventional study      Dosages of drug: None      Duration of treatment: Till patient improves or requires invasive ventilation.      Brief Methodology Patients of COPD with acute exacerbation will be randomized into two groups     (group A and group B) to receive NIV-PSV or NIV-NAVA respectively. A special naso-gastric     catheter (EAdi-catheter) will be placed in all patients. In each mode, NIV will be applied     using a non-vented oro-nasal mask that will be fitted enough to avoid air leaks. Patients in     Group A will receive NIV-PS and Group B will receive ventilation via NIV-NAVA. Pressure     support and PEEP levels will be set by the treating physician to achieve a tidal volume (Vt)     of 6 to 8 mL/kg of ideal body weight. NAVA level will be adjusted to match peak pressures of     NIV-PSV using manufacturer-supplied software. After stabilization, a 30-min period of each     NIV trial will be recorded and manually analyzed offline. Subsequent readings will be taken     at 2, 6 and at 24 hours and then at 6 hourly interval from day 2 onwards. In each trial,     patient-ventilator asynchronies (ineffective efforts, auto triggering, premature cycling,     delayed cycling, and double triggering) will be determined on EAdi, airway pressure, and flow     signal. The number of each type of asynchrony, defined as the number of events per minute,     will be determined for each recording period. The asynchrony index (AI), in percentage, will     be calculated as described previously, and an AI >10% will be considered severe asynchrony.     Patient comfort level after each mode of ventilation will be assessed by using visual     analogue scale. Various clinical, ventilatory and arterial blood gas parameters will be     recorded.      Statistical analysis Data will be expressed as mean ± standard deviation (SD), or percentage.     Differences in continuous variables between the two groups will be compared using student's t     test (or Mann-Whitney U test); while differences in categorical data will be compared using     the chi- square test (or Fisher's exact test). A p value of less than 0.05 will be considered     statistically significant.   "
28496|NCT02912676|"     Acute Lymphoblastic Leukaemia (ALL) is the most frequent cancer in children. The survival     rate has improved significantly during the last decades, but the treatment still fails to     cure 15 % of the patients. Within the Nordic/Baltic countries, children are treated according     to the same protocol, i.e. NOPHO ALL-2008 protocol. Children and adolescents with     Lymphoblastic Non-Hodgkin's Lymphoma (LBL) are treated in accordance with the EURO-LB 02     protocol, whereas adults with Lymphoblastic Non-Hodgkin's Lymphoma in Denmark are commonly     treated in accordance with the NOPHO ALL-2008 protocol.      The longest treatment phase in both protocols is maintenance therapy, which is composed of     6-Mercaptopurine (6MP) and Methotrexate (MTX).      The cytotoxic property of 6MP relies upon conversion of 6MP into thioguanine nucleotides     (TGN), which can be incorporated into DNA instead of guanine or adenine. This incorporation     can cause nuclotide mismatching and cause cell death second to repetitive activation of the     mismatch repair system. At Rigshospitalet investigators have developed pharmacological     methods able to measure the incorporation of TGN into DNA (DNA-TGN). In a Nordic/Baltic study     the investigators have demonstrated higher levels of DNA-TGN during maintenance therapy in     children with ALL that do not develop relapse.      Preliminary studies indicate that the best approach to obtain DNA-TGN within a target range     could be a combination of 6MP, MTX and 6-thioguanine (6TG), as 6TG more readily can be     converted into TGN.      This study aims to explore if individual dose titration of 6TG added to 6MP/MTX therapy can     achieve DNA-TGN levels above a set target above 500 fmol/µg DNA, and thus can be integrated     into future ALL and LBL treatment strategies to reduce relapse rates in ALL and LBL.      The investigators plan to include 30 patients, and A) give incremental doses of 6TG until a     mean DNA-TGN level above 500 fmol/µg DNA is obtained; and B) analyze the changes in DNA-TGN     as well as cytosol levels of TGN, methylated 6MP metabolites, and MTX polyglutamates (the     latter two metabolites inhibit purine de novo synthesis and thus enhance DNA-TGN     incorporation), and C) occurrence of bone-marrow and liver toxicities during 6TG/6MP/MTX     therapy.   "
28497|NCT02912663|"     This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the     safety and feasibility of super-selective intra-arterial administration of verapamil and     magnesium sulfate immediately following successful endovascular thrombectomy as a potential     neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke.     This trial represents the first time that magnesium sulfate will be evaluated in human     subjects as a superselectively administered neuroprotective agent administered in an acute     time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the     first trial to evaluate combinational therapy for acute stroke neuroprotection.   "
29326|NCT02901795|"     All included patients will have their fetal heart rate recording performed with an EDAN F3     fetal monitor that allowed the back up recording of the fetal heart rate beat to beat     detection. Fetal heart rate variability analysis will be performed using Matalb® software.   "
28498|NCT02912650|"     This is a randomized, double blind, placebo-controlled, parallel group, single-center study     in approximately 560 subjects to determine the overall analgesic efficacy and safety of a     fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg     alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females     aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical     extraction of 3 or more third molar teeth. Following extraction, subjects must experience,     within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical     scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm     on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose     of study medication under double-blind conditions and then evaluated on site for 12 hours     following administration of study medication. Subjects will provide self-ratings of pain     severity and pain relief at various time points using categorical and numerical scales.     Additionally, subjects will also evaluate the time to first perceptible relief and time to     meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will     complete a categorical Global Evaluation of the study medication. A review of any reported     adverse events will also be completed.   "
33050|NCT02853162|"     Phase II study (n=30) to evaluate the safety and feasibility of stereotactic body radiation     therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).   "
28501|NCT02912611|"     This feasibility study will be conducted at 4 international sites located in Asia (Dhahran,     Nepal); Africa (Blantyre, Malawi and Kilimanjaro, Tanzania) and Latin America (Cochabamba,     Bolivia).      Each site comprises a cluster (including 3-4 health centers - 1 district hospital - 1     regional referral hospital) that service the population around the site area. Patients     presenting at a health care clinic or hospital emergency department with signs and symptoms     associated with high and moderate risk of developing AKI will undergo a point of care (POC)     test to measure serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and     a urine dipstick test for color, protein, glucose, blood and specific gravity. Patients who     meet the study inclusion criteria will be approached for consent. Patients enrolled in the     study will be followed throughout the health care evaluation and tracked through their course     by location i.e. health care center, hospital, and home. Outcomes will be recorded through 6     months following the health care evaluation.      The protocol will have an initial observation phase, during which relevant healthcare staff     and the research team will be trained to identify patients at moderate or high risk of AKI     and use of the point of care (POC) test for serum creatinine, saliva urea nitrogen dipstick     (exclusively in Malawi), and urine dipstick test. During this phase patients will be tracked     throughout the health care evaluation, however the teleconsultation will not be implemented     and no specific guidance for managing the patient will be provided.      During the subsequent intervention phase, the research team will interact with the local     healthcare providers to and the teleconsultation physician, providing guidance on the     management of the patient based on a standardized protocol. Protocols for patient care will     be pre-specified, with minor adjustments to meet local requirements.   "
28502|NCT02912598|"     Surgery involving the chest cavity, particularly VATS procedures, often require one-lung     ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation     with different models of bronchial blockers (BB) used in special populations and     circumstances. Their routine use is impeded by prolonged placement times, frequent     malpositionings and higher costs when compared to the DLT, as recently reported in a     meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen     tube with an integrated camera and a bronchial blocker allows for endobronchial placement     without the use of a fiberoptic bronchoscope. An external monitor provides continuous     visualization of the tracheal carina and the position of the bronchial cuff. The purpose of     this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to     a left-sided double-lumen tube and established bronchial blockers. The investigators     hypothesized a reduction in time to initial lung isolation due to the simplified placement     procedure compared to other bronchial blockers. Continuous intraprocedural airway     visualization may allow for early detection of dislocations. Necessary repositionings may be     possible without additional bronchoscopies, reducing both disruptions of ventilation and     maintenance costs.   "
28503|NCT02912585|"     Infections are the main causes of morbidity and mortality in very low birth weight infants.     Use of mother's own breast milk in feeding these babies is associated with a decreased risk     of acquiring nosocomial infection. This protective effect is assigned to a plurality of     immune components in human milk. However, clinical instability of the preterm newborn in the     first days of life results in delayed initiation of enteral nutrition. Thus, alternative     methods for colostrum administration have been investigated, such as oropharyngeal     administration with evidence that would be safe and feasible to perform in children admitted     to the NICU in the first hours of life. Objective: To evaluate the immune stimulatory effect     of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth     weight preterm infants.   "
28504|NCT02912572|"     This research study is evaluating a drug called Avelumab as a possible treatment for     recurrent or Metastatic Endometrial Cancer.   "
28505|NCT02912559|"     This randomized phase III trial studies combination chemotherapy and atezolizumab to see how     well it works compared with combination chemotherapy alone in treating patients with stage     III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in     combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as     atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving     combination chemotherapy with atezolizumab may work better than combination chemotherapy     alone in treating patients with colon cancer.   "
28643|NCT02910752|"     For acute leukemia patients with early relapse after allogeneic stem cell transplantation,     the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of     chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell     support from the original donor.   "
28506|NCT02912546|"     Postural changes are commonly used as therapeutic maneuver to enhance or reduce cerebral     perfusion. For instance, in acute stroke, the patient can be positioned in head down tilt     position so as to increase perfusion of cerebral tissues perfusion. In During stroke and in     hypertensive patients and during stroke, varying degrees a various loss of cerebral     autoregulation is loss are usually observed. The aim of this study is to assess cerebral     perfusion with ASL perfusion in human subjects in different conditions: healthy, hypertensive     and stroke.   "
28507|NCT02912533|"     The purpose of this study is to investigate the safety and efficacy for 52-week dosing of     JR-131 in renal anemia patients with chronic kidney disease (CKD).   "
28508|NCT02912520|"     Investigators hypothesize that Immunoglobine (Ig) production is influenced by the microbiota     of the gut. Investigators will compare microbiota-dependent Ig production in the     bronchoalveolar lavage fluid of patients with and without antibiotic therapy in order to     detect significant differences.   "
28509|NCT02912507|"     Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten     laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser   "
28510|NCT02911844|"     The main purpose of this clinical trial is to examine the feasibility and effects of     fulvestrant in post-menopausal women with pulmonary arterial hypertension (PAH). The study     will evaluate how well the drug is tolerated. The study will evaluate changes in circulating     hematopoietic progenitor cells, plasma hormone levels, NT-proBNP, and other plasma biomarkers     after the administration of fulvestrant. Changes in tricuspid annular plane systolic     excursion, stroke volume index, right ventricular fractional area change, and other echo     parameters after fulvestrant administration will be evaluated as well as changes in distance     walked in six minutes.   "
28511|NCT02911831|"     The objective of this study is to determine the effect of 1g of IV tranexamic acid given     within 1 hour pre-operatively on intraoperative blood loss at time of hysterectomy.   "
28535|NCT02912351|"     This is a retrospective, single-site observational study, designed to assess the clinical     outcomes and collect safety data of GMK Revision knee system used for primary or revision     total knee arthroplasty at minimum two years post-treatment.   "
28512|NCT02911818|"     This is a 52 week, single center, open-labeled, randomized controlled trial.      A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as     contraindications to weight loss, will be randomly assigned to one of three treatment groups:     1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid     Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e.,     CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component     Intervention).      Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the     first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration     of counseling visits recommended by CMS. Counseling sessions will be delivered by a     physician, nurse practitioner or registered dietitian (RD) working in consultation with the     former providers.      Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24,     36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide     groups to monitor their response to the medication. These visits are included for subjects in     CMS-Alone to match the intensity of medical care provided the two other groups.      The primary outcome is % reduction in initial body weight, as measured from randomization to     week 52. Secondary outcomes include the proportion of participants who at week 52 lose >5%,     >10%, and >15% of initial weight, as well as % reduction in weight at week 24 and the     proportion of participants who meet the three categorical weight losses at this time. The     secondary efficacy measures include changes (from randomization to week 52) in cardiovascular     disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior,     appetite, sleep, and satisfaction with weight loss.      Safety endpoints will include physical examination, adverse events (AEs), standard laboratory     tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS)     and Patient Health Questionnaire (PHQ-9).      Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a     randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the     Multi-Component Intervention provides >80% power to detect the two primary contrasts to be     statistically significant. This estimate allows for 20% attrition during the 52-week trial,     resulting in approximately 40 treatment completers per group. The ITT longitudinal     statistical design will further improve power by allowing the inclusion of available data for     non-completers and the adjustment of possible variance reducing baseline covariates.   "
28513|NCT02911805|"     This study will determine whether blood biomarker changes predict sight-saving benefits of     exercise.   "
28514|NCT02911792|"     The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or     without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated     group will serve as controls for improved glycemic control, since the investigators have     shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM     patients.   "
28515|NCT02911779|"     In order to determine the optimal angle to perform an episiotomy, the investigators assessed     the angle of marked episiotomy lines at the first stage of labor and at the time of crowning     of the head.      Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°,     and 60° angles from the midline, at the first stage of labor, in women with singleton     pregnancies. The angles of the marked lines were measured again at crowning of the head.     Mediolateral episiotomy was performed only for obstetric indications.   "
28516|NCT02911766|"     Chlorhexidine is the gold standard of dental plaque prevention, but which concentration is     the most effective is not known. The aim of the present study was to compare the plaque and     gingivitis inhibiting effect of commercial products containing 0.2%, 0.12% and 0.06%     chlorhexidine in a modified experimental gingivitis model.      In three groups of healthy volunteers, experimental gingivitis was induced and monitored over     21days, simultaneously treated with the commercial solutions containing 0.2%, 0.12% and 0.06%     chlorhexidine. The maxillary right quadrant of each individual received mouthwash only,     whereas the maxillary left quadrant was subject to both rinsing and mechanical oral hygiene.     Compliance and side effects were monitored at days 7, 14, and 21. Plaque and gingivitis     scores were obtained at baseline and day 21.      The commercial mouthwash containing 0.2% chlorhexidine resulted in statistically     significantly lower plaque scores than the 0.12 and 0.06% mouthwashes after 21 days use,     whereas no statistically significant difference was found between the effect of the two     latter mouthrinses.      A commercial available mouthwash containing 0.2% chlorhexidine proved statistically     significant better effect in preventing dental plaque than 0.12% and 0.06% solutions.   "
28517|NCT02911753|"     This study aims to 1) assess the feasibility and acceptability of a prescribed beverage     intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess     preliminary effects of the beverage intervention on cholesterol and triglyceride levels as     well as other markers of health such as blood pressure, glucose and markers of inflammation.     This project, if successful, will provide early evidence that targeting dietary behavior     around beverage intake could be a novel and easily adopted approach to reduce the burden or     delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of     the proposed project is the identification of feasible and appropriate beverage intervention     strategies to improve engagement and adherence to dietary modification approaches for control     of metabolic health indicators in this vulnerable ethnic group.   "
28518|NCT02911740|"     Tuberculosis (TB) is one opportunistic infection often seen in HIV individuals. In 2013,     there were an estimated 31,800 HIV-TB co-infection cases and 6,100 HIV-related deaths due to     TB in the Americas. Due to the non-specific nature of its clinical symptoms, TB can be     confused with various diseases such as histoplasmosis, sarcoidosis, lymphoma, and pneumonia.     In Panama, where Histoplasma capsulatum is endemic, diagnosing TB versus histoplasmosis based     on clinical symptoms can be difficult. In Panama, approximately 7.65% of HIV patients are     co-infected with histoplasmosis, and there is a 30% mortality rate in HIV-histoplasmosis     patients in Latin America. Due to similar clinical features, misdiagnosis of active TB and     disseminated histoplasmosis in endemic regions may lead to incorrect antibiotic management,     which in turn results in unnecessary toxicity, antibiotic resistance, and monetary     expenditures. The investigators interests lie in increasing TB diagnostic accuracy using a     simple urine dipstick test and evaluating physician response to new diagnostic testing, in     order to reduce misdiagnosis and improve health outcomes in the HIV population.   "
28519|NCT02911727|"     Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for     normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain     but improvements in management of pain may change this situation and make early discharge     possible. However, several aspects need to be considered.      The aim of this project is to evaluate fast-track discharge for multiparas after elective CS     concerning neonatal and maternal complications as well as the parents' sense of security and     well-being.      The study is a randomized controlled trial including 142 women allocated to either discharge     after 24-28 hours or standard discharge after at least 48 hours after elective CS.      This study will be among the first evaluating fast-track discharge after CS in a European     context. If a positive outcome is achieved, we expect that fast-track discharge can be     implemented with improved quality and reduced costs in postnatal care following elective CS.   "
28520|NCT02911714|"     Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in     the early detection of kidney transplant complications, such as delayed graft function (DGF)     and acute allograft rejection. The technique uses an intravenous contrast agent to improve     organ visualization with standard duplex ultrasound equipment. A number of FDA-approved     agents, including Optison, Definity and Lumason are widely used to improve visualization in     technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced     ultrasound of the liver. The specific aims of this study are to: develop, implement and     refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney     allograft visualization; determine associations between contrast-enhanced ultrasound and     patterns of allograft injury consistent with delayed graft function; and to compare     contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from     other causes of dysfunction.   "
28521|NCT02911701|"     NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure     over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the     setting of preeclampsia have not been well studied. This study aims to assess the effect of     avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with     preeclampsia with severe features. Eligible women will be randomized to receive either     acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies     for pain control although ibuprofen has better pain control than acetaminophen. The primary     outcome will be duration of postpartum severe-range hypertension.   "
28522|NCT02911688|"     To study the effects of 1200mg gamma tocopherol (yT), a form of vitamin E, given daily on the     response of the airway in mild asthmatics after exposure to ozone (O3)   "
28523|NCT02911675|"     Traumatic brain injury (TBI) is a leading cause of death following injury in civilian     populations and is a major cause of death and disability in combat casualties. While primary     brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of     secondary injury mechanisms which occur as part of the downstream effects of the primary     damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated     intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration of     elevated ICP is strongly associated with poor long term patient outcome.      Currently, there are two invasive techniques that are used at our facility for monitoring ICP     and CPP. The first method requires the placement of an intra-parenchymal fiberoptic pressure     monitor (IPM), also known as a camino, into the brain tissue that measures and displays ICP     continuously. The second method requires placement of an extracranial ventricular drain (EVD)     which both measures ICP when it is closed or clamped and also allows for therapeutic drainage     of cerebral spinal fluid (CFS) to reduce pressure within the skull when it is open.      While clinical practices vary greatly across institutions, current clinical practice at our     institution when using the EVD for ICP management is to allow continuous therapeutic CSF     drainage and to manually close the drain for ICP assessment on an hourly basis. However, in a     retrospective of study of TBI patients at our institution with simultaneous IPM and EVD     placement, a spike in ICP was noted to correspond with the clamping of the EVD which often     remained elevated for 15-30 minutes before returning to baseline. Due to the strong     association between poor patient outcome and elevated ICP, this finding is alarming. These     findings have important implications for procedures to not only treat elevated ICP, but also     prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to     prospectively investigate the association between EVD clamping and elevated ICP.      Specifically, this study has 2 main objectives:        1. Evaluate the need for an optimized device that can simultaneously measure intracranial          pressure and drain CSF without requiring potentially harmful clamping.        2. Provide data in support of retaining or modifying current clinical practices regarding          intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.   "
28524|NCT02912494|"     The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and     evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).   "
28525|NCT02912481|"     Arterial catheterization in small children is challenging, even for experienced     anesthesiologists. For successful arterial catheterization, the arterial diameter,     cross-sectional area, and depth from the skin surface are important considerations,     especially in pediatric patients. THe investigators examined the posterior tibial artery     (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative     arterial cannulation site to the radial artery (RA) in pediatric patients.   "
28591|NCT02911441|"     This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of     anxiety and depression living in insecure environments using a randomized controlled     methodology. Key outcomes of interest include maternal mental health and infant cognitive     development. The intervention will be delivered by community mental health workers who will     be trained to administer 8 to 12 cognitive behavioral therapy sessions.   "
28658|NCT02910531|"     This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone     recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily for     three years, while the other half will receive a placebo.   "
28527|NCT02912455|"     This is a prospective, randomized clinical trial for patients with recurrent type 2 diabetes     post-gastric bypass surgery that will compare a 6 month course of canagliflozin monotherapy     vs. placebo on clinical outcomes of type 2 diabetes.   "
28528|NCT02912442|"     The present Ph.D.-study investigates the mechanisms behind the association between thyroid     autoimmunity and reproductive failure.   "
28529|NCT02912429|"     There is currently no sufficient evidence if there is superiority of one of the two available     types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of     this study to compare the two types in a prospective comparative setting. Patients on the     waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type     patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter.     Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala     Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and     parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year     follow up data-sets.   "
28530|NCT02912416|"     Determine the effect of probiotics on improving iron status in a population of healthy,     pregnant women.   "
28531|NCT02912403|"     Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period.     Investigators will use a home blood pressure monitor that stays on the arm, and takes blood     pressures hourly. Participants will record any symptoms that they feel are attributed to high     blood pressure and pain medication use.   "
28532|NCT02912390|"     Through cervical length measurement in uncomplicated twin gestations, women with cervical     length ≤ 25 mm will be approached for randomization to cerclage placement or expectant     management with activity restriction and treatment of preterm labor   "
28536|NCT02912338|"     Purpose: To understand the change in body composition, physical functions and quality of life     of elderly residents with sarcopenic obesity in LTC facilities after the implementation of     exercise intervention.   "
28537|NCT02912325|"     The primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in     lowering serum lipids and glucose in subjects with Metabolic Syndrome;      The secondary objectives of the trial are:        -  to evaluate the potential benefit after 3 months of therapy (by an interim analysis)        -  to evaluate the safety of FaseMETS   "
28538|NCT02912312|"     The goal of this clinical research study is to compare how often arm swelling develops after     4 weeks of radiation treatment to how often arm swelling develops after 6 weeks of radiation     treatment in patients who receive radiation therapy delivered to the lymph nodes near the     breast. Researchers also want to know about other side effects that can develop during or     after radiation treatment.   "
28539|NCT02912299|"     This study investigates the differens in sodium storage in skin between normal subjects,     patients after cardiac surgery and septic patients.   "
28540|NCT02912286|"     The aim of this study is to compare the postoperative pain after root canal treatment     following irrigation by endodontic needle, sonic and passive ultrasonic irrigation     techniques.   "
28541|NCT02912273|"     To establish the optimal strategy of fall-risk assessment to predict falls in older adults     receiving cancer therapy.   "
28542|NCT02912260|"     The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on     the percent change in hepatic fat fraction from baseline in patients with biopsy-proven     Non-alcoholic Steatohepatitis (NASH).   "
28543|NCT02912247|"     This clinical study is a phase 1 study which carried out to establish the pharmacokinetic     equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal     antibody injection and Adalimumab when used as a single subcutaneous injection in healthy     volunteers.   "
28544|NCT02912234|"     This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose     pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).   "
28545|NCT02912221|"     This study will examine the benefits of a monitored physical activity program for     participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable     activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an     incentive is better than no incentive in maintaining an increased level of physical activity     and 2) the benefits of physical activity on patient reported disease activity in inflammatory     arthritis.   "
28546|NCT02912208|"     Myelodysplastic syndromes (MDS) prevail in older age and are characterized by ineffective     erythropoiesis and peripheral cytopenias. Supportive therapy is the main therapeutic option     for most patients. Quality of Life (QoL) is mainly deteriorated by anemia and by the     limitations associated with thrombocytopenia, neutropenia and transfusion dependence. The     only available treatment for severe thrombocytopenia, in the presence of bleeding, is     platelet transfusion.      Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. In adult     patients with chronic immune thrombocytopenia (ITP), Eltrombopag rapidly increases platelet     counts and significantly reduces bleeding episodes during treatment. Eltrombopag is well     tolerated. In 2007, Eltrombopag has received the Orphan Drug Designation for the treatment of     ITP (EMEA/OD/031/07), and in 2008 the Food and Drug Association approved Eltrombopag for the     treatment of ITP refractory or resistant. It has been shown that in patients affected by MDS     and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the     clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an     increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic     colonies. These results provide the rationale for pursuing further research on Eltrombopag     for the treatment of thrombocytopenia in case of MDS.      The study is open to adult patients with myelodysplastic syndrome (MDS) with thrombocytopenia     and low- or intermediate-1 IPSS risk (Index Prognostic Score System).      Severe thrombocytopenia associated with MDS may lead to death from hemorrhage, even in low     prognostic risk patients. The benefit of platelet transfusion is short-termed. Patients     become refractory in the long term. The availability of a treatment that induces the increase     of platelet count is extremely important, either in terms of quality of life, and in overall     survival.   "
28547|NCT02912195|"     Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider     chosen dose of IV morphine for the treatment of severe pain in the emergency department.      Study design: Open-label, randomized controlled pilot study.   "
28548|NCT02912182|"     Randomized placebo controlled trial on patients suffering from acute unilateral     vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short     corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).      Vestibular function as well as subjective symptoms will be estimated in the acute stage and     regularly up to one year after the debut.   "
28549|NCT02912169|"     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the disease pathology of patients with     Alzheimer's Disease and clinical outcomes?   "
28550|NCT02912156|"     A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different     Formulation of Voriconazole 200 mg Tablets in Healthy Adult Subjects.   "
28551|NCT02912143|"     The German Pediatric Hemophilia Research Database will collect data on the prophylactic and     therapeutic use of factor concentrates, complications, outcome measures (joint scores, QoL)     and living circumstances in newly diagnosed children with hemophilia.   "
28552|NCT02912130|"     This project will investigate the synergistic effects of Aerobic and Resistance type     Exercise, in combination with Protein Supplementation, on; Body Composition, Musculoskeletal     Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia.   "
28553|NCT02912117|"     Prospective, observational study at Stanford University Hospital comparing the Karius     Infectious Disease Diagnostic Sequencing Assay to the final microbiologic diagnosis in     patients with fever and neutropenia.   "
28554|NCT02912104|"     This project will clarify the safety and effectiveness of human amniotic epithelial cells     transplantation for the treatment of primary ovarian insufficiency(POI) patients and provide     a new therapeutic method for patients with infertility.   "
28555|NCT02912091|"     This study will look at blood sugar levels in pregnant women who have been given a     glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help     determine the likelihood, predictive value, adverse effects, response of patients diagnosed     with gestational diabetes and time course of blood sugar elevation following steroids.   "
28556|NCT02912078|"     This study will examine recent claims regarding the beneficial effect of warming epidural     medications in order to hasten the onset of labor analgesia.   "
28557|NCT02912065|"     A retrospective chart review to assess feeding tolerance in children who had been switched     from an intact protein formula to a Peptide based formula due to feeding intolerance in a     pediatric facility for the developmentally delayed.   "
28558|NCT02912052|"     A prospective Randomized Clinical Trial to investigate the Effect ofPeri-operative     Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable     Liver Metastasis   "
28559|NCT02912039|"     There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in     the clinical setting. The aim of this clinical investigation is to examine a prototype of a     quantitative monitoring instrument that will meet most, if not all, of the clinical     requirements.   "
28560|NCT02912026|"     Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318.     Five healthy male subjects will receive IV and five will receive an oral solution. Blood,     urine and faeces will be collected over a period adequate to obtain 90% recovery of parent     compound and to determine the metabolic profile of both IV and oral forms.   "
28561|NCT02912013|"     The Mē Mini is a compact version of the Mē device that was cleared by the FDA for removal of     unwanted hair and for permanent hair reduction for all skin colors (Fitzpatrick skin     photo-types I-VI) based on a series of multi-site clinical studies.      The purpose of this post-marketing study is to support the claims for removal of unwanted     hair and for permanent hair reduction in the compact version of the device.   "
28562|NCT02912000|"     The proposed study is a pre- /post-implementation study in a pediatric practice with a     control practice designed to test the feasibility and effectiveness of an electronic     screening and service delivery tool for three modifiable health risk factors in pediatrics:     parental tobacco use, sugar-sweetened beverages consumption, and poor dental care   "
28592|NCT02911428|"     The purpose of this study is to evaluate the post-vaccination immune status at different time     points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of     product administration; and, to assess safety of medicinal product GamEvacVector-Based     Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a     half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses.   "
28593|NCT02911415|"     The purpose of this study is to evaluate the post-vaccination immune status at different time     points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of     product administration; and, to assess safety of medicinal product GamEvac-Combi - Combined     Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the     immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic     doses.   "
28563|NCT02911987|"     Low back pain is a common disorder, occurring worldwide in both males and females in all age     groups. The prevalence is higher in females and the incidence peaks between 30 and 65 years.     It is currently the most frequent musculoskeletal cause of functional disability and it has a     major socio-economic impact on today's society. Although a small percentage of persons with     low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with     low back pain present with symptoms of nonspecific origin. A part of these symptoms are only     of short duration, but 23% of all people will develop nonspecific chronic low back pain     (NSCLBP).      Exercise therapy (ET) is currently an important component in the treatment of NSCLBP.     Previous studies analysed the effects of various modes of exercise therapy, such as motor     control therapy, core stability training and aerobic conditioning training. However, therapy     outcomes can be low, and guidelines in favour of using a specific program are contradictory.     It thus still remains unclear which therapy modality is best suited. Furthermore, no     recommendations are available about optimal training intensities during rehabilitation of     persons with NSCLBP.      Since as well aerobic as muscular deconditioning are apparent in persons with chronic low     back pain and improvements in overall physical fitness can affect therapy outcomes in this     population, ET specifically focussing on physical fitness can be advocated for NSCLBP     rehabilitation. High Intensity Training (HIT), has been promoted as an effective and     efficient training method for improving physical fitness and health related parameters in     healthy persons. Also, HIT resulted in successful reconditioning and improvement of     functional and disease related outcomes in persons with other chronic diseases such as     multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies     showed promising results for the effect of HIT on low back pain such as high intensity     isolated, evidence is still scarce and study results are unclear because of methodological     shortcomings.      The aim of this randomized clinical trial study is to evaluate the effects of a HIT program     on disease related outcomes, physical fitness and muscle contractile characteristics compared     to a conventional rehabilitation program in persons with NSCLBP.   "
28564|NCT02911974|"     This is a randomized prospective clinical study comparing a fine needle biopsy device and an     aspiration needle.   "
28565|NCT02911961|"     The objective of this study is to provide preliminary data to describe serum     acetaminophen-cysteine protein adduct (APAP-CYS) concentrations following therapeutic doses     of acetaminophen in the setting of non-acetaminophen induced liver injury. This study will     utilize hepatic embolization as a model of hepatic injury.   "
28567|NCT02911935|"     The main objective of the APW-RSV II clinical trial is to evaluate if the addition of     azithromycin to routine bronchiolitis care, among infants hospitalized with RSV     bronchiolitis, reduces the occurrence of recurrent wheeze during the preschool years.   "
28568|NCT02911922|"     Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016     NCCN criteria will be eligible to participate on this study.   "
28569|NCT02911909|"     The aim of this study is to determine if there is a difference in post operative     rehabilitation after anterior cruciate ligament (ACL) reconstruction surgery while using     moderated blood flow therapy vs. standard physical therapy. All patients undergoing ACL     reconstruction, between the ages of 18-30, that consent to taking part in the study, and meet     eligibility criteria, will be included in the study. Patients will be followed for two years     to determine any differences in muscle strength, thigh circumference, knee range of motion,     pain, functional and activity levels, patient satisfaction, levels of Human growth hormone     HGH), Insulin-like Growth Factor (IGF), and Creatine Kinase (CK), KT2000, and Lachman     physical examination.   "
28570|NCT02911896|"     Impairment in physical function is a significant problem for survivors of critical illness.     There is a growing urgency to develop a core set of outcome measures, which can be adopted in     clinical and research practice to evaluate efficacy in response to interventions such as     rehabilitation.      Phase 1: Development of a new outcome measure. This study aims to examine the development of     a single outcome measure which may be able to be utilised across the continuum of recovery of     critical illness in the evaluation of physical function. The study will involve examination     of two common physical function measures - the Physical Function in intensive care test     scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure     based on rasch principles which may be able to capture physical functioning changes in     individuals with critical illness. Aims: (1) To determine the clinical utility of two     physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital     admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure     to evaluate function in intensive care survivors using Rasch analytical principles.      Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an     independent validation sample.   "
33429|NCT02848209|"     The purpose of this study is to examine the histological skin changes induced by different     peeling agents (Trichloroacetic acid 25% and 40% and phenol/croton oil) in subcutaneous     undermined facial skin flaps.   "
28573|NCT02911857|"     The primary objective of this study is to evaluate safety and tolerability of ACZ885 in this     extension study. This extension study offers the opportunity for patients who completed Epoch     4 of the preceding CACZ885N2301 study to continue to be treated with ACZ885 until approval in     Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic     Fever Syndromes is suspended.   "
28574|NCT02911662|"     This is a prospective randomized controlled day comparing the efficacy of three-day     antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard     seven-day treatment. Half the patients will receive 3-day treatment and the other half will     receive 7 days of antibiotics.   "
28594|NCT02911402|"     Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions     Astrolabe, sometimes there is a risk of very significant dehydration. A special unit     specialized in the fundamental study of the vestibular system (inner ear), sensory organ at     the base of visual-vestibular conflict inducing this syndrome, also provides medical support     for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly     present. The goal of the study is to assess the frequency of occurrence of this sea sickness     syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality     traits, anxiety / stress) without changing habits on board for those on board taking a     antinaupathique treatment given by the ship's doctor. This study will be done in     collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER     specialized in extreme environments (Belgium). The ultimate goal will be to provide the best     recommendations and the best treatment regimen to alleviate as best as possible the symptoms     of people on board of the Astrolabe so scientists on board can perform their work.   "
28575|NCT02911649|"     Cancer-related fatigue (CRF) can be experienced by individuals with Prostate Cancer (PC),     which can have profound effects on their well-being. Although physical activity has been     shown to improve CRF, the recommended levels are generally not met. Step count and distance     traveled information can help individuals to increase their physical activity. Wearable     technology (WEAR) provides the user with feedback of their physical activity which can     motivate behaviour change. Similarly, education workshops (EDU) on the effects of sedentary     behaviour and physical activity may also reduce sedentary behaviour.      The objectives of this study are to evaluate the effects of WEAR and EDU on sedentary     behaviour and CRF, and to explore the feasibility of WEAR in this population. Participants in     this study will be randomly assigned into WEAR, EDU, WEAR+EDU, or control over a three-month     intervention. Assessments at baseline, post-intervention and a 3-month follow up will     evaluate CRF, quality of life and level of sedentary behaviour, and use of WEAR devices.      The results from this study will provide evidence-based knowledge on the impact of WEAR and     EDU on sedentary behaviour and CRF, and an understanding on the use of technology within the     PC population. These results can shape the development of programming for CRF and the use of     scale-able technology-based interventions/approaches in this population.   "
28576|NCT02911636|"     Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with     simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5     fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes +     6-18 months of ADT   "
28577|NCT02911623|"     To observe early safety and performance of the Shockwave Medical Lithoplasty® System     (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and     3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively     deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic,     infrapopliteal arteries.   "
28578|NCT02911610|"     The use of arthroscopy with the surgery of wrist fractures has a great health and economic     impact (prolongs the time of surgery, requires adequately trained personnel, increases the     time and surgical expenses and the risk of complications, however, in return ameliorate the     prognosis and improves the functional recovery). There are few clinical trials showing a     sufficient level of evidence in comparing the results of the surgical treatment of these     fractures with volar plate and added arthroscopy so it is necessary to perform a clinical     trial with an appropriate design and a sufficient sample size to elucidate the usefulness of     arthroscopy in wrist fractures. Therefore, the investigators want to perform an open and     controlled clinical trial to adequately analyze the role of arthroscopy in the surgical     treatment of wrist fractures in the investigators hospitals.      The main objective of the study is to probe the arthroscopy effectiveness in the     functionality of the injured wrist by PRWE (a questionnaire assessing pain and wrist     function) between the treatment groups of the trial at 12 months after surgery and for this     the investigators plan a phase IV multicenter clinical trial.   "
28579|NCT02911597|"     The primary objective is to determine if the opioid properties of ketamine are responsible     for its antidepressant effects. Since naltrexone can block opiate actions, the investigators     will determine if naltrexone can effectively block ketamine's effects.   "
28580|NCT02911584|"     This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse     Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial     is designed to test the clinical and functional effects of the two different laparoscopic     procedures in terms of anatomical correction of the prolapse, post-operative and long term     morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a     quality of life questionnaire.   "
28581|NCT02911571|"     This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment     intention decisions in active Multiple Myeloma patients.   "
28582|NCT02911558|"     The aim of the study is to estimate the impact of the implication of a Mobile Team of     Palliative Care (EMSP) on the palliative strategy in the units with concerned patients. The     Mobile Team of Palliative of Foch hospital Care was created in March, 2011.   "
28583|NCT02911545|"     Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective     alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There     are yet limited real life data on outcomes following elective cardioversion in AF patients     treated with NOACs. The aim of this study is to investigate the complications and the use of     NOACs in AF patients undergoing cardioversion.   "
28584|NCT02911532|"     The purpose of this study is to determine whether tissue engineering conjunctiva is effective     in the treatment of pterygium and atretoblepharia.   "
28585|NCT02911519|"     This study evaluates the addition of psychoeducation to treament as usual in the treatment of     adults with schizophrenia for relapse prevention. Half of partipants will receive a brief (5     sessions) psychoeducation intervention and treatment as usual in combination, while the other     half will receive treatment as usual only.   "
28586|NCT02911506|"     The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in     intensive care unit patients at high risk.   "
28587|NCT02911493|"     To determine the change in sedentary time and number of steps/day for older patients with     heart failure at risk for mobility disability who receive a program to decrease sedentary     behavior versus a standard program to increase exercise.   "
28588|NCT02911480|"     The current study is designed as a phase I multiple dose study to evaluate the     pharmacokinetics and bioavailability of [14C]-labelled oxytocin in healthy women.   "
28589|NCT02911467|"     This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging     with Hyperpolarized Pyruvate (HP) (13C) as a predictive response biomarker to androgen     signaling inhibition in patients with castration-resistant prostate cancer.   "
28590|NCT02911454|"     A prospective, multi-country, open label study to describe the stool characteristics and     behaviour as well as the parents' experience in infants receiving a recently launched infant     formula in a real life situation.   "
28595|NCT02911389|"     The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a     web-based platform or paper manual is a safe and effective alternative to outpatient physical     therapy after total knee replacement.   "
28596|NCT02911363|"     The main purpose of this study will be to two-fold; firstly to determine whether the use of a     Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing     artifactual curling) , and secondly to determine whether the use of a intraprocedural     cassette is practical. The investigators believe that this will greatly aid in elucidating     the best technique for optimizing performance of EMR for esophageal lesions.   "
28597|NCT02911350|"     The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel     and Radiation therapy are effective in treatment of locally advanced prostate cancer   "
28598|NCT02911337|"     The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle     modification program on symptoms and signs of heart failure as well as laboratory and     echocardiographic measures of cardiac structure and function. This will be a 6 month trial in     50 patients with a clinical diagnosis of heart failure with preserved ejection fraction     (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight     management 15 week lifestyle change program which will involve weekly visits that rotate     among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with     the research Registered Nurse. Each patients baseline data will be used as the control and     compared with the same measurements at the 6 month end point.   "
28599|NCT02911324|"     The purpose of this pilot research study is to test the effects of a medication called     nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will     receive either nabilone on its own, or nabilone in combination with a form of     cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone     is a synthetic cannabinoid and acts on the brain's endocannabinoid system, which has been     hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of     chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.   "
28600|NCT02911311|"     Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic     retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40     years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection     of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal     neovascularization(NV). The purpose is to assess and compare the efficacy and safety between     intravitreal injection of conbercept and PRP.   "
28601|NCT02911298|"     This is a Phase I, open label, single-site trial to evaluate the in vivo release     characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to     disintegrate in the large intestine. This will be examined by means of metronidazole plasma     levels and scintigraphic images in healthy subjects. Overall, nine subjects will be evaluated     for each formulation prototype. Two formulation prototypes will be investigated. Each subject     will receive one radio-labelled capsule only.   "
28602|NCT02911285|"     As a result of sustained operations in Afghanistan and Iraq, there are an increasing number     of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress     disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at     increased risk for developing other mental health problems (e.g., depression, anxiety),     suicidal ideation and attempts, medical problems, reduced resiliency and military readiness,     vocational problems, and family/social impairment. This study will determine the benefits of     N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress     disorder (PTSD) among military Veterans.   "
28603|NCT02911272|"     Objective: To compare active labour outcomes in nulliparous women at term supervised with a     partograph with the action line placed at either 2 hours or 4 hours and to determine whether     the 2-hour action line placement is better for the prevention of prolonged labour.      Design: Randomised controlled trial.      Setting: A university teaching hospital in Nigeria.      Population: Nulliparous women in labour at term.      Method: Nulliparous women in labour were randomly supervised with a partograph with the     action line placed at 2 hours (n=320) or 4 hours (n=320). Oxytocin augmentation, when     required, was used only at the 2-hour (n=87) or 4-hour (n=61) action lines. Progress     monitoring was the same in both groups.      Main outcome measure: The primary outcome measure was the prolonged labour rate. The     secondary outcome measures were the mode of delivery and neonatal outcome.   "
28604|NCT02911259|"     The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery     (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These     results, however, are based on traditional drainage systems with water seal and need to be     confirmed using digital drainage systems.      Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10     cmH2O when looking at chest tube duration and complications.   "
28605|NCT02911246|"     Malnutrition is defined by an energy supply deficit, protein, macro-molecules or     micro-nutrients, resulting from an imbalance between nutrient intakes and metabolic needs of     the body. It concerns 40 to 60% of patients upon entry into resuscitation and influences     their prognosis. Studies over the past decade have shown that nutritional deficiency     increases the morbidity and mortality in intensive care.      Several clinical and biological parameters were evaluated as markers of malnutrition,     including the ratio of urea / urine creatinine.      The report would identify patients in a state of malnutrition, to optimize their nutritional     care.      This setting is easy to obtain in all patients by simple urine collection unlike other     clinical and biological criteria of resuscitation malnutrition assessment.      This ratio of urea / urien creatinine would optimize energy intake of critically ill     patients, for which nutritional management methods are widely debated.   "
28630|NCT02910921|"     This trial is collaboration between Mayo Clinic, Second Opinion Health (Simon Bloch,     simon@somobilehealth.com 408-981-3814) and Allergan. Mayo Clinic investigators are conducting     the clinical trial, Second Opinion Health is providing the software for use in the trial     (Migraine Alert app for data collection, analysis and machine learning algorithms), and     Allergan is providing funding.      The investigators hypothesize that the use of a mobile phone app and Fitbit wearable to     collect daily headache diary data, exposure/trigger data and physiologic data will predict     the occurrence of migraine attacks with high accuracy. The objective of the trial is to     assess the ability to use daily exposure/trigger and symptom data, as well as physiologic     data (collected by Fitbit) to create individual predictive migraine models to accurately     predict migraine attacks in individual patients via a mobile phone app.   "
28606|NCT02911233|"     Hemophilia A is a rare X chromosome-linked recessive bleeding disorder that concerns one     individual in 5000. In its severe form, hemophilia A is a life-threatening, crippling     hemorrhagic disease. The treatment of bleeding episodes in hemophilia A patients involves the     administration of exogenous human FVIII to restore normal hemostasis. The main complication     of the substitutive treatment of hemophilia A is the development, in 15 to 30% of the cases,     of anti-FVIII antibodies (FVIII inhibitors) that neutralize the pro-coagulant activity of     therapeutically administered FVIII. In 2003, the average annual cost of care for a patient     with hemophilia A was evaluated to be equal to 63,000 euros (2), which, in France (6000     patients), represents an annual budget of 378 million euros.      In order to reduce the cost of treatment and to bypass this complication, different     therapeutic strategies (new products or adjunctive therapeutic options) have been explored,     including platelet infusion, tranexamic acid, amino caproic acid, molecules that block tissue     factor pathway inhibitor, combination of phospholipid -Factor Xa- Factor XIII and antibodies     directed to the Tissue Factor Inhibitor Pathway (TFPI). Recently, Soluble thrombomodulin     (Solulin) have been developed. This molecule may be used to partially correct the premature     lysis defect in Factor VIII deficient plasma through an activated TAFI - dependent mechanism.      With a long half-life (15- to 30-hour) and effective dose range estimated to range from the     sub-nanomolar to approximately 40nM, Solulin could potentially be administered on a weekly     basis and provide the basis for a factor-sparing regime that would cut costs and make therapy     more widely available. However, before proceeding to advanced trials, safety concerns     stemming from the anticoagulant properties of Solulin must be addressed. The development of     Solulin mutants lacking protein C activation capacity would make this concern redundant. At     the same time, such mutant molecules are likely to possess an effective dose range.      Our project is to compare the behavior of recombinant Solulin and mutants of Solulin lacking     protein C activation capacity with respect to their ability to stabilize fibrin clots in     whole blood of humans with different coagulation factor deficiencies (hemophilia A,     hemophilia B and rare blood coagulation deficiencies (factor X, VII, V).   "
28607|NCT02911220|"     The intrinsic asthma (atopic or not) is a particular phenotype marked by an early later     symptoms, increased severity, sensitivity associated with nonsteroidal anti-inflammatory     drugs (NSAIDs), a sinonasal polyposis and eosinophilia.      Unlike allergic asthma, this form does not today demonstrated its genetic character. However,     the existence of familial forms of asthma in this region Pays de La Loire led us to     hypothesize the existence of genetic variations can explain some familial forms of non-atopic     asthma. Corresponding genes may be relevant to understanding the pathophysiological pathways     involved in the more common sporadic forms.      The investigators propose a study combining genetic linkage analysis and complete sequencing     exomes to identify one or more genetic abnormalities associated with non-atopic asthma. The     clinical stage essential for mutation identification is to identify and recruit large     families with members affected by non-atopic asthma and ensure accurate phenotyping of all     individuals recruited over several generations.      The aim of this study is to create a cohort of families who have more members within them     non-atopic asthma. A high genetic combined exome sequencing throughput analysis in a family     linkage study will then reveal the presence or absence of genetic variations associated with     intrinsic asthma.   "
28608|NCT02911207|"     There are very few studies on emotion management in chronically ill patients. They usually     include small sample size (less than 30 persons) and are not randomized controlled trials.     However, emotion management is an essential coping skill in mental well-being and quality of     life and is the subject of numerous studies in psychology.The investigators hypothesized that     a creative and physical activities combination in chronically ill will promote the     strengthening of emotion management skill. The investigators will conduct an innovating study     combining quantitative and qualitative variables in a randomized controlled trial to confirm     our hypothesis.   "
28609|NCT02911194|"     Under double-blind, placebo-controlled, cross-over conditions, the short-term effects of use     of A1 beta casein free milk (a2 milk) and milk containing A1 beta casein will be compared in     a sample of pre-pubescent boys diagnosed with an autism spectrum disorder (ASD) with     concurrent features of attention-deficit hyperactivity disorder (ADHD).   "
28610|NCT02911181|"     Observational study to investigate nutrition state in all admitted patients in ICU.     Measurement by BIVA and SNAQ score.   "
28611|NCT02911168|"     The purpose of this study is to compare the proximal intercostal block to the more medial     (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the     proximal intercostal block will allow for improved needle visualization, shorter block time,     and improved safety profile compared to the classic paravertebral bock.   "
28623|NCT02911012|"     The aim of this study is to overcome the current limits of the scoring systems used to     predict both the thrombotic (VTE) and hemorrhagic (BLD) risk for the patient. The main     problem of these scoring systems is due to the high rigidity related to the score assigned at     each risk item. The presence of an item assigns the full score for that item, without the     possibility to moderate that item's score. The final class of risk, for the patient, is the     sum of the scores of the selected items. The approach used for the assessment is based on the     presence or absence of certain items that will be summed.      Starting from scoring system currently used for VTE (PADUA, CAPRINI, KHORANA) and also for     BLD (IMPROVE), we will integrate all common items in a single scoring system managed by risk     management algorithms that can identify the different classes of risk.   "
28612|NCT02911155|"     Background:      The field of nuclear medicine has changed a lot in the past decades. Technology has gotten     better, so patients are exposed to less radiation. But now workers are doing procedures more     often and using lead aprons less. So they may be exposed to more radiation. This may put them     at higher risk for cancers and other health problems that are related to radiation.     Researchers want to collect data from technologists to learn more about the risks and     appropriate doses of radiation.      Objective:      To learn more about the risks and appropriate doses of radiation for nuclear medicine     technologists.      Eligibility:      Adults who were first certified in nuclear medicine technology in the United States after     1980. They must be living in the United States. They must not be participants in the USRT     study.      Design:      Participants will be recruited online.      Participants will complete an online survey. It will take about a half hour. This will have     questions about their work with nuclear medicine procedures. There will be questions about     the kinds of procedures and how often they do them.      Participants will give a short work history. This will include the names of current and past     employers.      Participants will allow researchers to get records of their film badge dose readings. These     will come from dosimetry providers.      Dosimetry data will not be shared with participants. Researchers can t ensure the how     accurate or complete the data are.   "
28640|NCT02910791|"     Atopic dermatitis and psoriasis are two skin diseases often associated with bacterial     infections and inflammation. Studies indicate that skin cells from these patients may have     some changes that make these patients more susceptible to bacterial infections. Inflammatory     environment may have an effect on the function of skin cells.      The purpose of this study is to learn more about skin cells (keratinocytes and fibroblasts)     and how they regulate skin barrier function. To study this we need to establish skin cells     that can be grown in the laboratory. We will use small skin biopsies from patients with     atopic dermatitis, psoriasis and healthy people as a source of these cells. Since these skin     cells have a limited lifetime when grown in laboratory as part of the project we would like     to modify them, which allows them to grow for long time in the research laboratory. Some of     the collected skin biopsies and isolated skin cells will be used to examine what gene     products they make.   "
29396|NCT02900885|"     Retrospective medical chart and medical imaging file review of patients suffering from palsy     of the superior rectus extraocular muscle   "
28613|NCT02911142|"     Background:      Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers     want to see if a drug called lenalidomide along with common chemotherapy drugs may be     effective in treating PEL.      Objective:      To test a new treatment for PEL.      Eligibility:      People ages 18 and older with PEL.      Design:      Participants will be screened with blood tests, imaging studies, a physical exam, and other     tests.      Participants will have tests to evaluate their disease. These may include:      Blood tests      Scans      Lumbar puncture. Fluid around the spinal cord will be removed with a needle.      Bone marrow removed with a needle and studied      Samples of skin or lymph nodes removed      Fluid removed from around organs      Lung and eye tests      Tubes with cameras taking pictures of airways or digestive tract      Participants will take lenalidomide pills for 10 days. They will keep a pill diary.      Participants will have a catheter (small tube) placed in the large vein in the arm or chest.      Participants will get DA-EPOCH-R as intravenous infusions by catheter over several days. This     will be repeated in 21-day cycles. Most participants will have 6 cycles.      Participants will get the drug filgrastim by injection under the skin. They will get the drug     methotrexate injected into the spinal fluid.      During the study, participants will have the following tests done at least once:      Medical history      Physical exam      Blood, urine, and stool tests      Lesions photographed and measured      Lumbar puncture      Participants will have follow-up visits for 5 years. They will repeat the screening tests     plus have urine and stool tested.      Participants may be contacted later by phone to see how they are doing....   "
28614|NCT02911129|"     Background:      After a stroke, the balance between the two halves of the brain can be lost. This may cause     people to lose the ability to perceive a side of space. This is called neglect. Having people     wear prism glasses (called PA) can reduce neglect symptoms. Researchers want to find out more     about how PA, and whether it restores the balance in the brain.      Objective:      To learn how prism adaption temporarily changes vision and connections in the brain.      Eligibility:      People ages 18 75 with brain damage of the right side of the brain from a stroke or other     cause, leading to neglect.      Healthy volunteers ages 18 75.      Design:      Participants will have 1 3 visits.      Participants will be screened with a neurological exam. They may also have:      Tests of thinking and vision      Tests to see which eye and hand they prefer      A pregnancy test      All participants will:      Answer questions about their personality, style of thinking, and beliefs.      Do simple tasks on paper or computer      Have magnetic resonance imaging. They will lie on a table that can slide in and out of a     cylinder in a strong magnetic field. Participants will lie still or do computer tasks in the     scanner.      Participants may also have:      Transcranial magnetic stimulation. A brief electrical current passes through a wire coil on     the scalp. This creates a magnetic pulse that affects brain activity. Participants may be     asked to tense certain muscles or perform simple actions or tasks.      PA. They will sit in front of a board and point to a dot on it while they wear prism glasses     that shift vision to the left or right.   "
28624|NCT02910999|"     This study intends to describe the real-life effectiveness and safety of nivolumab in     advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the     quality of life.   "
28625|NCT02910986|"     This study will examine behavioral and psychological outcomes of breast density notification     using a 3-group randomized design comparing usual written notification to two educationally     enhanced approaches.   "
28626|NCT02910973|"     Persistent chronic inflammation is an important underlying event in multiple diseases     including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These     disorders are characterized as inflammatory in part because of the important mediating role     of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether     transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease     the inflammatory cytokine response in healthy individuals.   "
28627|NCT02910960|"     This is a randomized prospective clinical study comparing the Acquire Biopsy Device to     SharkCore Biopsy Device.   "
28615|NCT02911116|"     Background:      Uveitis is an inflammation of the eye that can cause vision loss. It is treated with     medications and sometimes surgery. However, in many people, treatment does not always prevent     loss of vision. A new medication, ustekinumab, reduces inflammation in patients with other     inflammatory diseases. Therefore, it might be helpful in treatment of uveitis.      Objective:      To see if ustekinumab is safe and can help people with uveitis.      Eligibility:      People ages 18 and older with uveitis      Design:      Participants will be screened with:      Medical and eye disease history      Physical exam      Eye exam: The pupil is dilated with eye drops. A machine scans the back of the eye. Pictures      are taken of the inside of the eye.      Blood and urine tests      Tuberculosis test      Participants will have 6 clinic visits over 28 weeks. Visits lasts 2-3 hours and include:      Medical and eye disease history      Physical and eye exams      Blood and urine tests      Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is      injected into the tube. The dye travels through the veins up to the blood vessels in the     eyes. A      camera takes pictures of the dye as it flows through the blood vessels in the eyes.      Ustekinumab injections at Weeks 0, 4, and 8: The injection is under the skin of the upper      arm, leg, or abdomen.      Participants will have their uveitis monitored and receive standard uveitis care during the     study.   "
28616|NCT02911103|"     Researchers want to test a procedure called deep brain simulation (DBS) to treat focal hand     dystonia (FHD). A device called a neurostimulator is placed in the chest. It is attached to     wires placed in brain areas that affect movement. Stimulating these areas can help block     nerve signals that cause abnormal movements.      Objectives:      To test DBS as treatment for FHD. To learn about brain and nerve cell function in people with     dystonia.      Eligibility:      People ages 18 and older with severe FHD who have tried botulinum toxin treatment at least     twice      Design:      Participation lasts 5 years.      Participants will be screened with:      Medical history      Physical exam      Videotape of their dystonia      Blood, urine, and heart tests      Brain MRI scan      Chest X-ray      Neuropsychological tests: answering questions, doing simple actions, and taking memory and     thinking tests.      Hand movement tests      Participants will have surgery: A frame fixes their head to the operating table. A small hole     is made in the skull. Wires are inserted to record brain activity and stimulate the brain     while they do simple tasks. The wires are removed and the DBS electrode is inserted into the     hole. The neurostimulator is placed under the skin of the chest, with wires running to the     electrode in the brain. They will have CT and MRI scans during surgery.      Participants will recover in the hospital for about 1 week.      The neurostimulator will be turned on 1 4 weeks after discharge. Participants will have     regular visits until the study ends. Visits include:      Checking symptoms and side effects      MRI      Movement, thinking, and memory tests      If the neurostimulator s battery runs out, participants will have surgery to replace it.   "
28617|NCT02911090|"     The purpose of this data registry is to prospectively collect data from patients referred to     an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term     patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and     endometriosis.   "
28852|NCT02907996|"     The objectives of this study are to collect and assess data related to safety and     effectiveness of Sovaldi treatment regimens, per the approved prescribing information for     Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug     Safety (MFDS).   "
28618|NCT02911077|"     Background:      Many bacteria live in the gut. The gut is the tube that moves food from the mouth through the     stomach to the intestines. Heavy alcohol use disturbs these bacteria. There is evidence that     the bacteria in the gut may affect anxiety and depression. Researchers want to learn more     about these bacteria in order to better treat diseases such as alcohol dependence.      Objective:      To identify the different bacteria that live in the mouth and gut. Also, to learn if these     bacteria change as a person goes through alcohol detoxification.      Eligibility:      People ages 18 and older who:        -  Enrolled in screening protocol 14-AA-0181        -  Are going through detoxification treatment at the Clinical Center      Design:      Participants will have physical exams.      Participants will answer questions about:        -  Anxiety and depression        -  Alcohol use        -  Sleep        -  Abdominal and oral health        -  Diet      Participants will keep a regular record of their diet.      Participants will have breath alcohol analysis 4 times per day.      Participants will provide stool and oral specimens at most once a day for the first week.     Then, they will provide them once a week while they are at the Clinical Center.        -  For the oral specimen: A small brush rubs the tongue. They may not eat, drink, or          perform oral care within 2 hours of collection.        -  For the stool specimen: They will receive a container that fits in the toilet. They will          let the nurse know right away when the sample is ready.      Participants will have a dental visit. This consists of an oral exam and oral health     assessment. The dentist may recommend a cleaning or dental X-rays.   "
28619|NCT02911064|"     The goal of this research study is to learn if there is a difference between your     expectations of how well you will perform daily living activities after short-term inpatient     rehabilitation and the doctor's expectations of how well you will perform daily living     activities.   "
28620|NCT02911051|"     The clinical study evaluates the safety of a new catheter for Urinary Intermittent     Catheterisation in self catheterized patients   "
28621|NCT02911038|"     The aim of this observational study is: producing complete dental prosthesis with the aid of     CAD-CAM (Computer aided design & manufacturing) - 3D printing (Stereolithography) technology     - using as printable material Poli(methylmetacrylate) - PMMA - with Nano TiO2 nanoparticles     composite completely characterized.   "
28622|NCT02911025|"     The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness     in people with Epilepsy.   "
28628|NCT02910947|"     Two ultrasound guided techniques to give postoperative pain relief to the patients following     abdominal surgeries would be compared using scoring systems for pain relief and scientific     methods. while one technique is routinely used, other i.e quadratus lumborum has been     recently described and relies on posterior deposition of the drug. Both the techniques are     safe and ultrasound imaging is to be used for guidance.   "
29686|NCT02897102|"     The aim of this study was to investigate the effects of a structured program, which was based     on abacus training associated with other activities, administered as weekly group classes     over a 7 month period in older adults.   "
28629|NCT02910934|"     This study aims to provide National Malaria Control Programs (NMCP), international donors and     other key stakeholders with clear evidence on the impact and cost-effectiveness of using     indoor residual spraying (IRS) with a non-pyrethroid insecticide in a high malaria     transmission area that has universal long-lasting insecticidal net (LLIN) coverage. This is     an interventional study with IRS serving as the research intervention.      The district of Mopeia, in the province of Zambezia, Mozambique will be the study site. This     is a high transmission area with a malaria parasite prevalence of 54% in children. The     Ministry of Health distributed LLINs in Mopeia in 2014-2015.      The NMCP through funding from President's Malaria Initiative Africa Indoor Residual Spraying     Project (PMI-AIRS) was able to cover half a district with indoor residual spraying. A     simplified census took place in mid-2016 to determine the number of children five years of     age and under in the district and enumerate and map the households to assist in     implementation.      From the 115 villages/bairros existent in Mopeia, 86 clusters were randomized in a government     randomization ceremony to either receive IRS with Actellic or maintain no IRS. The IRS was     implemented through a partnership between the NMCP and PMI-AIRS according to standard     operational and consent procedures. From each cluster, a cohort of 18 children five years of     age and under will be followed monthly to assess malaria incidence at the community level in     both IRS and non-IRS villages. There will be 774 children in the IRS villages and 774     children in the no-IRS villages (total cohort will be 1548). Additionally, the routine health     centre reporting system will be strengthened to assess malaria incidence in children five     years of age and under by passive case detection. Two cross sectional studies in April 2017     and April 2018, will assess changes in net use, health seeking behaviour and malaria     prevalence at the community level.      Entomological data will be collected from both IRS and non-IRS areas to assess the vector     dynamics and insecticide resistance pattern of the local vector populations from sprayed and     unsprayed areas. Data on the costs of the implementation as well as health-related     expenditures at health system and household levels will be collected prospectively throughout     the study. These costs will be determined using both health system and societal perspectives.      The incidence rate in IRS and no-IRS areas will be combined with the micro-costing data to     calculate the cost per case averted at community and health facility level.      These findings will be disseminated to the NMCP and international donors and stakeholders to     complement the WHO guidance on combining indoor residual spraying and long-lasting     insecticidal nets.   "
28680|NCT02910245|"     This project is a double-blind, randomized, placebo-controlled, multicenter trial in the     Netherlands. The aim of this study is to investigate the therapeutic efficacy of optimized     6-mercaptopurine (6-MP) in ulcerative colitis patients. Therapeutic drug monitoring (TDM)     will be performed in order to optimize treatment outcomes and objective endoscopic endpoints     will be used.   "
28631|NCT02910908|"     Elderly (i.e.>75 yrs) represent about 40% of incident dialysis patients in the French REIN     Registry and are growing population in high income countries. Those elderly patients with CKD     have a high risk of dying within the first months of dialysis start or could have a good     long-term prognosis suggesting kidney transplantation access. Elderly patients with CKD also     have a higher risk of dying than reaching ESRD. Therefore, outcomes of elderly patients with     advanced CKD need to be better described and understood to be able to give accurate     information to the patients and their relatives and help decision making concerning the     treatment strategy including several options (i.e preemptive kidney transplantation, in     center or home dialysis and conservative care). In France we have information about patients     who started dialysis with French dialysis registry (REIN) but not about elderly patient     treated with conservative care. Then we don't have information about description of the     therapeutic project in this population and their evolution in a prospective cohort design.     Finally we need to identify patients with high risk of early mortality to help shared     decision making for better care organisation.      The project of the study is the development of a French multicenter prospective cohort     including elderly patients more than 75 years old reaching ESRD. Objectives are as follow:      Description of the characteristics of the population such as, clinical and social conditions,     medicine treatment, therapeutic project declared by nephrologist and laboratory value at     inclusion.      Description of the evolution of therapeuic project, kidney function and the outcomes defined     as death or dialysis or kidney transplantation.      Development of a mortality prognosis tools to help decision making in this population.   "
28632|NCT02910895|"     Outside the setting of well-designed prospective clinical studies, the current standard     preoperative RT should be a conventionally 1,8-2 Gy fractionated regimen to a total dose of     50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also     unlikely to assume a uniform radiotherapeutic management to be optimal for all sarcomas     alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated     in the past and should be further exploited in the future, but the practical implementation     in humans is hampered by the rarity of the disease. This platform may form the basis for     preclinical radiotherapy investigations.   "
28633|NCT02910882|"     This is a single arm phase II trial assessing the potential activity of combination PEGPH20     plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic     adenocarcinoma.   "
28634|NCT02910869|"     This observational study will investigate the potential clinical utility of the Pathway Fit®     test by investigating whether patients who successfully lose weight (defined as losing at     least 5% of body weight 8 weeks after initiation) in the MOVE! or TeleMOVE! Weight Management     programs have a distinct nutrigenetic profile over those that were unable to lose a     significant amount of weight. We will use electronic records to identify all individuals who     have successfully completed the MOVE! program (i.e. attended the full 8 week course) or     TeleMOVE! program. In addition we will find age- and gender- matched individuals who attended     and completed the MOVE! or TeleMOVE! programs but did not lose weight. After completion of     the MOVE! or TeleMOVE! programs Veterans will submit a saliva sample for the Pathway Fit®     test. Also, blood will be collected for storage for further studies on metabolomics. The     start and end weight of all participants will be recorded. The nutrigenic profiles of those     with successful weight loss will be compared to those less successful to determine if this     cohort has a particular genetic profile.   "
28635|NCT02910856|"     ELDERL-IE is a multicenter national prospective observational study.      The main objective is to describe geriatric characteristics (comorbidities, cognitive status,     autonomy, nutritional status, balance and walking) in patients aged 75 years or older with     infective endocarditis (IE).      The secondary objectives are to assess the impact of geriatric features on the medico -     surgical care and on morbidity and mortality at 3 months after the end of the     hospitalization, and to describe the initial clinical presentation and diagnostic modalities     in the IE elderly.   "
28636|NCT02910843|"     Despite treatment of locally advanced rectal cancer relapses are frequent. Several attempts     to improve these results with therapy intensification have shown modest effect on disease     free survival (DFS) and overall survival (OS). Recent studies with addition of sorafenib and     cediranib revealed promising effect on tumor response with acceptable toxicity. Regorafenib     is a multi tyrosine kinase inhibitor (TKI) with a broad mechanism of action. Therefore this     trial investigates if similar results can be achieved as with sorafenib or cediranib.   "
33430|NCT02848196|"     The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT     technique in oligometastatic patients affected by adrenal gland metastases.   "
28637|NCT02910830|"     The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first     multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It     guarantees its methodology great representativeness and therefore an interesting material for     the study of risk factors in the population. In addition, it should have little here     Radiographs of hands for all its patients. It therefore has the opportunity to study a     possible relationship between tobacco and hip osteoarthritis , knee and hand but also to     study the relationship between tobacco and structural evolution of hip osteoarthritis and /     or symptomatic knee.   "
28638|NCT02910817|"     a quasi-experimental study to investigate whether metformin co-treatment would improve IVF     outcomes in overweight and obese women with PCOS.   "
28639|NCT02910804|"     This is an open-label positron emission tomography/near infrared (PET/NIRF) study to     investigate the imaging navigation performance and evaluation efficacy of dual modality     imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of     40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected     intravenously before the operation and intraoperative respectively. Visual and     semiquantitative method will be used to assess the PET images and real-time margins     localization for surgical navigation.   "
28641|NCT02910778|"     To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced     vasodilatation of the forearm resistance vasculature as assessed by forearm blood flow (FBF)     measurement before and 10 min after a 20 min forearm ischemia. The area under the dose-effect     curve (AUC) of different ACh doses will be calculated and compared between treatment groups     (atorvastatin + ticagrelor vs. placebo + ticagrelor) and different time points (pre-ischemia     vs. post-ischemia).   "
28642|NCT02910765|"     effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their     implications upon outcome   "
28644|NCT02910739|"     This study consists of Part I and Part II. The purpose of Part I is to compare the plasma     pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of     40 mg MK-8931 to participants with moderate hepatic insufficiency (HI) to that of healthy     matched controls. A safety and pharmacokinetic analysis will be performed in order to support     the decision to continue with part II. If a decision to continue with part II is made,     participants with mild HI will be enrolled to receive a single oral dose of MK-8931 40mg. If     any healthy participants from Part I do not meet the matching criteria for Part II additional     healthy participants will be enrolled.   "
28645|NCT02910726|"     This study is being done in patients that have tumors to find out how well sentinel lymph     nodes (SLNs) can be found with a special dye called indocyanine green (ICG).   "
28646|NCT02910700|"     The goal of this clinical research study is to learn if nivolumab and trametinib (with or     without dabrafenib) can help to control metastatic melanoma in patients who have a BRAF,     NRAS, or BRAF-wild-type mutation.   "
28647|NCT02910687|"     In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75 years     old or older, were included between September 2009 and June 2010. The purpose of this     observational study (FINE75+5) is to describe these patients, especially regarding the     following variables: cardiovascular risk, co-morbidity and frailty, and to assess the     prognostic value of frailty on 5-year outcomes. We hypothesize that frailty is independently     associated with 5-year mortality.   "
28648|NCT02910661|"     The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize     Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at     improving medication adherence in adolescent kidney transplant, for use in 'real world'     clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs     and preferences of stakeholders (kidney transplant recipients, parents, and healthcare     professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.   "
28649|NCT02910648|"     This research is being done to study the impacts of a computerized learning task on health     behaviors. The investigators are interested in studying whether this computerized learning     task can help with weight loss.   "
28650|NCT02910635|"     The primary objective of this study is to assess the corrected QT interval (QTc) effect of     volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300     mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy     adult male and female subjects.   "
28651|NCT02910622|"     The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and     targeted therapies - is currently defined by criteria for population groups and not to an     individual. These expensive treatments - in financial terms and quality of life - will be     effective for some and administered unnecessarily for other because there is no predictive     test of response for a given individual.      For breast cancer, the usual treatment includes the first surgery and adjuvant therapies     (chemotherapy, hormonal therapy ...) whose effectiveness will be assessed after many years as     the occurrence or not of a recurrence or metastases.      These systemic treatments can also be administered before surgery to reduce the tumor volume     and secondarily allow less mutilating surgery: it is the principle of treatment neo adjuvant.     In this case, the efficiency will be evaluated more quickly.      In practice, a patient with breast cancer suspicion has a biopsy which confirms the diagnosis     and defined the parameters (hormone receptors, cytological grade, receptor monoclonal     antibodies ...) that guide to the most appropriate type of treatment.      Tumor size is evaluated in neo adjuvant pre-treatment by imaging: mammography, ultrasound and     MRI.      At the end of this medication, the evaluation of the response is achieved by radiology and     surgery.      Pathological examination evaluates and precise response by the criteria of Chevallier and /     or Sataloff. An ex vivo test for predicting the response of cells to different chemotherapy     regimens, the oncogramme, was developed by Oncomedics, a young company whose technology is     derived from the University of Limoges.      Clinical response and / or histopathological could be compared in a reasonable time (2-6     months), the results of the oncogramme proposed by Oncomedics whether the efficiency obtained     in vivo is that predicted by the ex vivo test.      It is the same in the metastatic setting when there is an available target for biopsy and     assessment of response.      The management of ovarian cancer in advanced stages can also benefit from a radiological and     histopathological evaluation strategy before and after systemic treatment to compare the in     vivo results with those predicted by ex vivo by Oncomedics.   "
28652|NCT02910609|"     The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are     conservative approach, pharmacological intervention and surgical ligation. There is not any     randomized-controlled trial that demonstrates the superiority of these approaches in preterm     infants.   "
28653|NCT02910596|"     Compare the effectiveness of bethanechol chloride and early bladder training for prevention     of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.   "
28654|NCT02910583|"     This study is to determine the clinical minimum residual disease (MRD) response with the     combination of ibrutinib plus venetoclax in subjects with treatment-naive chronic lymphocytic     leukemia (CLL)/small lymphocytic lymphoma   "
28655|NCT02910570|"     This is sub-study to a randomised, double blind, placebo-controlled, parallel group, and     single-centre trial investigating the effect of liraglutide on body weight and pain in     overweight or obese patients with knee osteoarthritis (NCT02905864).      In the parent trial patients will be subjected to a run-in diet intervention phase (week -8     to 0) including a low-calorie diet and dietetic counselling. At week 0 patients will be     randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to     dietetic guidance on re-introducing regular foods and a focus on continued motivation to     engage in a healthy lifestyle.      This sub-study of the parent trial only involves an additional assessment of skin auto     fluorescence (AGE concentration) in the preallocation phase and in the main trial phase, i.e.     from enrollment (defined as signature of informed consent) to treatment allocation (visits     -Tx and T0 in the parent trial visit schedule) and from allocation to end of trial (visits T0     and T15 in the parent trial visit schedule).   "
28656|NCT02910557|"     A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC®     (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic     Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in     Treated Patients   "
28657|NCT02910544|"     This is a substudy to a randomised trial investigating the effect of liraglutide on body     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In     the parent trial, patients will be subjected to an 8-week diet intervention phase including a     low-calorie diet and dietetic counselling, after which.they will be randomised to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.      This substudy aims to investigate any changes in physical activity associated with the     initial 8-week weight loss intervention.   "
28659|NCT02910518|"     Primary Objective:      To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test     formulation and insulin glulisine 100 Units/mL reference formulation after a single     subcutaneous (SC) dose.      Secondary Objectives:        -  To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK)          characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after          a single SC dose.        -  To assess safety and tolerability of the test and the reference formulation of insulin          glulisine.   "
28660|NCT02910505|"     Single center study to evaluate the safety and efficacy of an investigational version of the     Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.   "
28661|NCT02910492|"     Single-center study to evaluate the safety and efficacy of an investigational version of the     enlighten™ 670nm laser for photo-rejuvenation.   "
28662|NCT02910479|"     E-Celsius device used for measuring the gastrointestinal temperature is composed of an     ingestible capsule measuring the temperature as well as a transportable module receiving data     from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during     transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The     main risks related to such devices are related to biocompatibility (in materials used for the     capsule shell, or level of contamination of the gastrointestinal environment due to a defect     in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials;     see section 10.2).      It will compare conventional methods of estimating the central temperature continuously with     gastrointestinal data obtained from the e-Celsius device. The main objective of the research     is to validate the extent of gastrointestinal temperature obtained from the device under test     consists of an ingestible electronic capsule and a data reception monitor.      Secondary objectives will be pursued:        -  Assess the effects of ingestion of cold drinks on temperature readings taken via          e-device Celsius, esophageal probe and a rectal probe.        -  Explore the thermal homogeneity of the digestive tract.        -  Evaluate the internal memory of the capsule and its data forwarding capacity. This          protocol will also measure the reliability of the measurement system while comparing it          to the standards used by health staff today.   "
28663|NCT02910466|"     Chronic hypoparathyroidism is a life-long disease for which the chronic administration of     rhPTH(1-84) is a potential treatment option. The group of subjects in the AAAE0544 core study     has been taking rhPTH(1-84) for the treatment of hypoparathyroidism for up to 11 years. This     study is designed to extend this experience and gain knowledge about how safe and effective     rhPTH(1-84) is in patients with hypoparathyroidism over a long-term duration.   "
28664|NCT02910453|"     The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy     and direct vision. This technique has some advantages but its morbidity is significant. Some     surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact     on chest wall and the impairment on respiratory mechanic. However, an evidence for     superiority of the approach minimally invasive is lacking, particularly for the difficult     assessment of the change in pulmonary function. The aim of this study is to compare VATS-     over open lobectomy regarding the differences of chest wall kinematic, analyzed by     optoelectronic plethysmography (OEP).   "
28665|NCT02910440|"     The primary objective of this study is to compare the efficacy of DCL-101 to GoLYTELY in     preparing the large bowel for colonoscopy. Additional secondary objectives will compare the     safety of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy and compare the     tolerability of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy.   "
28675|NCT02910310|"     This study is a prospective, systematic evaluation to assess the effectiveness and safety of     introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource     countries. The first component of the evaluation is a prospective stepped wedge cluster     randomized design to assess the potential reduction in PPH-related mortality and invasive     procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial     embolization) for PPH performed at participating facilities following introduction of UBT.     The second component is a nested cohort analysis to assess the safety and acceptability of     UBT among women diagnosed with PPH.   "
28676|NCT02910297|"     The purpose of this study is to determine if cannabidiol (CBD) obtained via the state of     Minnesota reduces seizures in patients with severe intractable epilepsy (Dravet Syndrome or     Lennox Gastaut Syndrome), and to measure blood levels of CBD to help determine CBD     concentration-response characteristics.   "
28666|NCT02910427|"     Cerebrovascular disease is the second leading cause of death in Taiwan. Although stroke     incidence and mortality decline steadily in Taiwan, its impact on medical cost, quality of     life and neurological deficits remains extraordinary. Stroke incidence and mortality are also     rising in the developed countries presumably due to a world-wide increase in prevalence of     obesity and metabolic syndrome. Negative associations have been observed between high blood     pressure, hyperglycemia and two major dietary cations in vegetables and dairy products:     potassium and magnesium. Mean levels of dietary potassium and magnesium intake in Taiwan are     much lower than those of dietary reference intake. Short term supplementation studies have     demonstrated their effects in reducing blood pressure and degree of insulin resistance.     However, long-term studies on cardiovascular events are lacking. Our previous long-term     intervention trial in elderly veteran home showed a 41% reduction in cardiovascular mortality     by simply switching regular cooking salt to potassium-enriched salt in kitchens. The     investigators have previously observed an annual reduction of medical cost around $ 15,000 NT     in the aforementioned veteran home trial. A multi-centered randomized controlled trial was     carried out with three arms: (1) regular salt (Na salt), (2) potassium-enriched salt (K     salt), and (3) potassium and magnesium-enriched salt (K/Mg salt). The objectives of this     study was to investigate whether potassium and magnesium-enriched salt would improve the     neurological performance of the stroke patients.The investigators anticipate to observe     beneficial effect from consuming potassium and magnesium enriched salt for neurological     improvement in stroke patients.   "
28667|NCT02910414|"     The TARGET BP I Trial is a randomized, double-blinded, multi-center, international,     sham-procedure controlled trial, comparing renal denervation performed with the Peregrine     System Kit in the treatment group to the sham control group (without renal denervation - no     alcohol infusion). Subjects will be randomized in a 2:1 fashion to treatment versus sham     control via central randomization.   "
28668|NCT02910401|"     Rhinovirus (RV) infections represent the most common cause of asthma exacerbations in     children and adolescents. The investigators hypothesize that the immune responses generated     in the nose of allergic rhinitics and asthmatics underlie subsequent systemic modulation of     the immune system, and that - in susceptible individuals (i.e., those with pre-existing     asthma) - this modified nasal milieu is responsible for the asthma exacerbation.      Open label single center study in asthmatics as well as allergic rhinitis (AR) and healthy     controls. All subjects will undergo good manufacturing practice (GMP) RV16 inoculation and     responses will be compared between the 3 cohorts.   "
28669|NCT02910388|"     To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct     colposcopic Vision.   "
29397|NCT02900872|"     Systematic retrospective study of medical charts and medical imaging files, of patients     consulting for acute neck pain and presenting unclassified abnormalities on dedicated vessel     imaging.   "
28670|NCT02910375|"     This retrospective multi-centric Belgian prospective trial will involve 10 patients     initiating or under maintenance subcutaneous golimumab therapy for moderate-to-severe colitis     at the University Hospitals Leuven (Leuven, Belgium) or AZ Groeninge (Kortrijk, Belgium)      Patients will (have) receive(d) standard induction therapy with golimumab 200mg at week 0,     and golimumab 100mg at week 2. Maintenance therapy will (have) start(ed) at week 6, with 50     or 100mg of golimumab every 4 weeks, depending on body weight (50mg every 4 weeks for     patients with a body weight of less than 80kg, and 100mg for the others)      Patients will come to the hospital for clinical evaluation, blood sampling and golimumab     administration following daily clinical practice. The patients will be requested to perform     several dry blood spot analyses at home.   "
28671|NCT02910362|"     This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior     chamber during standard phacoemulsification surgery.      What is known:        -  Fluidics control is determined to be one of the primary drivers of physician decision          making in choosing phacoemulsification equipment.        -  Active pressure system fluidic control has a perceived and possibly real (based upon          recent literature) improvement in intra-cameral IOP stability and reduced pressure          fluctuations.        -  Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned          phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health          post-operatively.   "
28672|NCT02910349|"     Severe aortic regurgitation is a common valvular heart disease with prevalence of     approximately 1%, affecting rather younger patients. The surgical treatment is the only     causal treatment; it is recommended in patients with severe symptomatic aortic regurgitation.     The optimal timing of the surgery is crucial because there is a certain risk of perioperative     mortality and most patients require lifelong anticoagulation therapy. It is widely accepted,     that asymptomatic patients with severely dilated left ventricle with systolic impairment have     worse postoperative prognosis. We aim to evaluate native myocardial T1 relaxation time     derived from cardiac magnetic resonance and global longitudinal left ventricular strain     measured by echocardiography. These parameters are related to diffuse myocardial fibrosis and     we expect to identify the cut off values, which correlate with further clinical course. This     might enable better timing of the surgical treatment with the optimal postoperative left     ventricular reverse remodelling and improved patient prognosis.   "
28673|NCT02910336|"     Orofacial pain, specially neuropathic orofacial pain, is a challenge of diagnosis and     treatment in orofacial pain. It is associated with sensory abnormalities.With increasing life     expectancy of the population is more and more common to find individuals with chronic     diseases however, there is little evidence about the influence of comorbidities and     medications in use on sensory thresholds of neuropathic orofacial pain. Objective: to     investigate the influence of comorbidities and medication in somatosensory function of     patients with orofacial neuropathic pain compared to controls.In this case-control study, 336     orofacial pain patients and controls were recruited from the Hospital das Clinicas da     Faculdade de Medicina da USP were investigated about comorbidities, use of chronic     medication, pain characteristics and a detailed standardized protocol of somatosensory     evaluation at the trigeminal territories for cold, warm, tactile, vibration, deep,     superficial and electric pain thresholds.   "
28674|NCT02910323|"     The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is     a prospective, multicenter, observational research network for subjects with Cluster Headache     and/or Trigeminal Neuralgia.   "
28678|NCT02910271|"     AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in     asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the     current recommendations regarding for PAD screening in T1DM.      METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of     patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for     detecting classic symptoms of intermittent claudication, and after verifying the absence of     symptoms and exclusion criteria, they will be included in the study. All patients will     undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk     factors, as well as, an analytical assessment of the lipid profile, HbA1c level,     proinflammatory profile and oxidative stress status. They will also undergo a comprehensive     anthropometric assessment including office blood pressure (BP) monitoring and ambulatory     24-hours BP monitoring in patients with an indication as routine clinical practice,     assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler     ultrasound, in the context of routine clinical practice in patients with clinical indication,     or as an extraordinary procedure for participating in the study in patients who do not meet     criteria for screening according to current recommendations.   "
28679|NCT02910258|"     Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs     (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly     α2a) are eligible to this prospective study. Biological and clinical parameters will be     collected from the beginning of the drug use until last news.      A non-opposition consent form need to be signed before entering this study.   "
28681|NCT02910232|"     Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone     regeneration. In this project we will used our new invention, porous starch- hydroxyapatite     composite, for in vivo clinical trial.   "
28682|NCT02910219|"     Chemotherapy induced diarrhea is seen in up to 40-80% of patients receiving this treatment     for HER2 positive locally advanced or metastatic breast cancer. This diarrhea can     significantly impact a patient's quality of life and ability to tolerate chemo/anti-HER2     therapy. This study will look at the efficacy of the drug crofelemer in preventing diarrhea     in breast cancer patients.   "
28683|NCT02910206|"     Elderly patients have high mortality and postoperative complications rate after surgery,     especially postoperative cardiac complications. A meta-analysis revealed haemodynamic     intraoperative events significantly increased the risk of postoperative cardiac     complications.To limit the risk, optimize the intraoperative management of circulation is     essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of     postoperative complications should aimed at choosing the optimal anesthetic drug with minimal     effect on haemodynamic.So this study is to explore the comparative efficacy and safety of     anesthetic drug (etomidate or propofol) in elderly patients   "
28684|NCT02910193|"     The goal of the multicenter subproject (SP) 10 of the eMED Alcohol Addiction Consortium - A     Systems-Oriented Approach is to study neuroimaging x genetics predictions in an existing     sample (NGFNplus) of tightly endophenotyped and genome-wide genotyped alcohol dependent     subjects (N=240) and controls (N=240); (ii) to translate the results of neuroimaging and     genetic analyses from an adolescent risk sample (IMAGEN) to adult disease (NGFNplus sample)     by examining related MRI-paradigms tagging the same functional brain systems in both samples     (e.g. reward system, inhibitory control system, emotion processing, working memory); (iii) to     conduct a follow-up neuroimaging study on the NGFNplus sample validating the neurobehavioral     risk profiles predictive for juvenile harmful alcohol use in adult patients with alcohol     addiction, (iv) to expand the NGFNplus sample by including a new set of healthy subjects with     high genetic risk (1st degree relatives of patients with alcohol addiction). The     investigators will do so by using elaborate imaging genetic methods that are already     available and successfully used in other multicenter studies by the investigator's research     group (e.g. univariate analyses, functional and effective connectivity analyses, polygenetic     scores, network topology) as well as by using complex computational algorithms and     mathematical models, in particular advanced machine learning methods, developed in SP 6. The     investigator's approach aims in the long to predict and characterize longitudinal outcomes in     patients with alcohol addiction (5 years following our index session) and to complement the     NGFN-sample with an add-on study with 1st degree relatives that will allow the investigators     to test the generalizability of the identified predictive risk profiles for early risk     identification.   "
28685|NCT02910180|"     This study encompasses the maintenance and utilization of a repository of samples from     patients with cerebrovascular disease and stroke. The types of tissue taken are blood,     cerebrospinal fluid (CSF), tissue, and microdialysis samples. Future analysis of these     samples can potentially help investigators to better categorize groups of patients,     understand the underlying etiology of these pathologies, identify markers that are associated     with favorable or poor outcomes, and track changes that occur during the natural course of     the disease or with treatment. This is a prospective observational study which will use     samples from such patients to create this library which can be used to explore these     questions in the future.   "
28686|NCT02910167|"     What AE occur in routine clinical practice, what is the incidence of AE and ADR, how many     patients present with AE symptoms related to a potential liver injury. What are the drug     utilization patterns in patients, what are the predisposing factors for the occurrence of     adverse events and adverse drug reactions.   "
28687|NCT02910154|"     Angina is the most common symptom of coronary heart disease among women but unlike men most     women do not have stenosis of the coronary arteries. In a large proportion of these women,     coronary microvascular dysfunction (CMD) is thought to be the cause of angina. However, CMD     is also demonstrable in the asymptomatic population, and may merely be an innocent bystander     related to the presence of cardiovascular risk factors rather than a cause of angina     symptoms.      The aim of this study is to determine whether comprehensive intervention is feasible and     results in improvement in both angina and microvascular function in these patients.   "
28688|NCT02910141|"     This study aims to compare glycaemic control during continuous subcutaneous insulin fusion     (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to     identify patient-level characteristics that predict the best improvement in control and any     change in insulin dose or other outcome.   "
28690|NCT02910115|"     The objective of the study is to demonstrate whether cooling the uterine smooth muscle during     cesarean section (following delivery of the fetus) will promote better uterine contraction     and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer     hysterectomies following cesarean section for dysfunctional labor.   "
28691|NCT02910102|"     This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in     patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.   "
28692|NCT02910089|"     The purpose of this study is to evaluate whether a combination of pharmacist-delivered     patient engagement techniques improves disease control and medication adherence among     patients with poorly-controlled diabetes compared with usual care. These engagement     techniques include shared decision-making and brief negotiated interviewing and are delivered     telephonically.   "
28705|NCT02909907|"     To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor     muscles versus flexors alone for the treatment of essential hand tremor (ET).   "
28706|NCT02909894|"     Research shows that sitting for long periods of time on a regular basis is bad for health and     can leave individuals more susceptible to Obesity, Cardiovascular Disease, Type 2 Diabetes     and premature death regardless of exercise engagement outside of these seated hours.      As sitting is so common in modern society it is vital that research explores ways to protect     individuals from this worsening issue. Investigators want to see if breaking up long periods     of sitting time with short, frequent bouts of light physical activity, while remaining     seated, is enough to alleviate these risk factors.   "
28693|NCT02910076|"     Antimalarials such as hydroxychloroquine (HCQ), are among the oldest prescribed drugs still     used in clinical practice. Relatively inexpensive and well tolerated, these drugs have been     recognized to be effective in autoimmune diseases such as rheumatoid arthritis (RA) and     systemic lupus erythematosus (SLE). Interestingly, there is growing evidence of their     beneficial impact on cardiovascular risk, particularly diabetes. HCQ therapy can improve     balance in patients with unbalanced diabetes. This drug therapy may be a new therapeutic     approach for diabetes. There is need for a better understanding of the mechanisms responsible     for the improvement of the metabolic response to drug treatment. The investigators     hypothesize that treatment with a drug improves the function of the beta cell and its ability     to secrete insulin in response to glucose. The investigators will examine the impact of     short-term therapy for HCQ in beta cell function in healthy volunteers and in patients with     type 2 diabetes.   "
28694|NCT02910063|"     This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the     treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after     2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study     incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size     re-estimation. In the phase 3 part of the study, blinatumomab will be compared to     Investigator's Choice chemotherapy.   "
28695|NCT02910050|"     This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor     in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after     treatment of an aromatase inhibitor.   "
28696|NCT02910024|"     The present prospective, randomized, controlled, double-blinded trial investigates the     effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after     stroke. Patients with hemipresis will receive either sham or real iTBS over their affected     hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after     the intervention phase and three months after enrollment.   "
28697|NCT02910011|"     This study will investigate the safety and clinical efficacy of a novel doxycycline topical     formulation in subjects with Atopic Dermatitis (AD). The investigators hypothesize that daily     application of the study drug in AD subjects will reduce severity of the disease, by reducing     skin driven inflammation and restoring skin barrier function. The investigators will also     monitor the anti-microbial activity of this product on AD skin, as colonization with Staph     aureus is typically associated with disease severity.   "
28698|NCT02909998|"     Use of genotyping for the optimization of treatment with biologics in chronic arthritis by     looking for an association between certain alleles and response to treatment.   "
28699|NCT02909985|"     This pilot study will evaluate the visual response to infrared (IR) in humans after dark     adaptation. The investigators plan to determine which wavelength and intensity the human eye     is most sensitive too, using a broad spectrum light source and wavelength-specific bandpass     filters. The investigators will then evaluate the electrophysiologic response in healthy     humans to IR, followed by studies in those with specific retinal diseases.      The long-term goal of this research is to better understand the role that IR plays in visual     function, and whether this can be manipulated to allow for vision in certain retinal     pathologies that result from loss of photoreceptor cells. The investigators central objective     is to test the electrophysiologic response to IR in the dark-adapted retinal and visual     pathways. The investigators central hypothesis is that IR evokes a visual response in humans     after dark adaptation, and the characteristics of this response suggest transient receptor     potential (TRP) channel involvement. The investigators rationale is that a better     understanding of how IR impacts vision may allow for an alternative mechanism for vision in a     number of diseases that cause blindness from the degradation or loss of function of     photoreceptor cells. The investigators will test the investigators hypothesis with the     following Aims:      Aim 1: To determine the optimal IR wavelength for visual perception in dark-adapted human     participants. The investigators hypothesize that the healthy human eye will detect IR     irradiation, with a maximum sensitivity at a specific wavelength. Using a broad-spectrum     light source with wavelength-specific bandpass filters, the spectral range of visual     perception to IR will be evaluated. The same will be done on colorblind participants.      Aim 2: To test the electrophysiologic response to IR in healthy humans after dark adaptation.     The investigators hypothesize that IR will elicit an amplitude change on electroretinography     (ERG) and visual evoked potential (VEP) responses after dark adaptation in healthy human     participants. Participants will be tested with both test modalities to evaluate their     response to IR.      Aim 3: To test the electrophysiologic response to IR after dark adaptation in humans with     certain retinal diseases. Participants with retinitis pigmentosa, age related macular     degeneration and congenital stationary night blindness, will be tested. Results will be     compared to baselines and to those of healthy participants. The investigators hypothesize     that there will be a response to IR on ERG and VEP, which will provide clues to the retinal     cell layer location of the response to IR and the nature of potential TRP channel     involvement.   "
28700|NCT02909972|"     Phase I, open label, multi-center dose escalation (DEP) and dose expansion (EXP) study     designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and     anti-tumor effects of ALRN-6924 in patients with acute myeloid leukemia or advanced     myelodysplastic syndrome with wild-type (WT) TP53.   "
28701|NCT02909959|"     The aim of this randomized controlled trial is to determine if a nutritional supplement     containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in     reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the     safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its     effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such     as hyperactivity, irritability, and repetitive movements.   "
33431|NCT02848183|"     The purpose of this study is to optimize therapy according to the known risk factors and     treatment response in pediatric acute myeloid leukemia (AML)   "
28702|NCT02909946|"     Multidrug-resistant organisms (MDROs) are endemic in nursing homes (NHs) with prevalence     rates surpassing those in hospitals. The aim of the study is to design and evaluate the     effectiveness of a multi-component intervention to reduce new acquisition of MDROs in NH     residents. The intervention will incorporate resident-level, environmental, and caregiver     based strategies. Using a cluster-randomized study design, three NHs will be randomized to     the intervention group and three to the control group. Control NHs will be allowed to     continue standard infection prevention practices. Nursing homes will serve as the unit of     allocation. Analyses will be performed both at the resident and the cluster level. The     primary outcomes of the study are reduction in MDRO prevalence, and reduction in new MDRO     acquisition .   "
28703|NCT02909933|"     Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS)     is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an     anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.      We investigates short term interventions with low dose liraglutide in combination with     metformin and high dose liraglutide alone influence on significant weight reduction in obese     women with PCOS.   "
28704|NCT02909920|"     Shoulder pain is a common and high prevalence in the general population. Subacromial Syndrome     (Shoulder Impingement Syndrome (SIS)) is the most frequent cause. SIS patients suffering     pain, muscle weakness and loss of movement in the affected joint. Initial treatment of the     SIS is predominantly conservative. Surgical option has high success rates and is often used     when conservative strategy fails. Traditional Physiotherapy and Postoperative exercises is     needed to the recovery of joint range, muscle strength, stability and functionality. This     Research evaluates the feasibility and effectiveness of a telerehabilitatión Program in SIS     after surgery compared with traditional therapy.   "
28707|NCT02909881|"     PhytoSpherix (Phx) is an all-natural, edible polysaccharide extracted from sweet corn. This     carbohydrate is the major muscle fuel for intense exercise and its stores are quite small     such that one can run out of it during a single exercise bout. Therefore, Phx should provide     significant exercise fuel if consumed during exercise. As a result its intake could enhance     intense exercise performance by providing additional fuel. This experiment Will investigate     the effects of 4 different dosages of Phx consumed throughout a prolonged exercise bout on     carbohydrate and fat utilization as well as its oxidation rate and perception of effort     during prolonged intense exercise in trained cyclists. Muscle and liver carbohydrate stores     will be examined using a non-invasive ultrasound technique.   "
28708|NCT02909868|"     The position of the RV lead may have an important role in the effectiveness of the     Programmable Hypertension Control (PHC) therapy by the Moderato pacemaker eliciting a lag     from which RV signals (QRS) are identified.      The study attempts to measure RV Pressure and RV Volume with PHC in two RV lead locations.   "
28709|NCT02909855|"     This study investigates whether there are psychological predictors of parental perception of     side-effects following vaccination with the child flu vaccine. We will also investigate     whether the perception of side-effects affects parents' intention to vaccinate their child     again in the following flu season, as well as whether there are underlying differences in     parents' cognitive biases between those who do and do not re-vaccinate their child.   "
28710|NCT02909842|"     This blinded randomized controlled trial aims to investigate the effect of drinking fermented     milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.   "
28711|NCT02909829|"     Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a     good range is a difficult task. A primary source for poor glucose control in adolescents is     skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the     research towards closed-loop delivery systems to automatically regulate glucose levels.     Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous     glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on     sensor readings. The performance of a closed-loop delivery after a missed bolus may be     improved if the computer program that calculates the insulin is enhanced with a meal     detection module. The meal detection module will automatically detect the meal (which had no     bolus delivered), and signal the delivery of more insulin.      The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and     without meal detection module compared to conventional pump therapy in regulating     post-prandial glycemic levels after omission of a meal bolus.      The primary hypothesis is that closed-loop delivery with no meal detection module will reduce     the mean increase in postprandial glucose levels after a missed bolus compared to     conventional pump therapy.   "
28712|NCT02909816|"     The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric     Dental Patients. The investigators performed a multicenter observational study. The     investigators included patients aged 1 to 18 years and who have already failed dental care     because of non-cooperation; they could be with mental or cognitive disabilities and could     have sedative premedication. The investigators performed any type of dental care With the Use     of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after     dental care.   "
28713|NCT02909803|"     It is not known whether different lentil varieties have the same efficacy in lowering blood     glucose. Similarly, the carbohydrate component of lentils responsible for lowering blood     glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol     bioactive.   "
28714|NCT02909790|"     The purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level     Laser Therapy for circumference reduction of the waistline.   "
28715|NCT02909777|"     This research study is evaluating a novel drug called CUDC-907 as a possible treatment for     resistant (refractory) pediatric solid tumors (including neuroblastoma), lymphoma, or brain     tumors.   "
28716|NCT02909764|"     The goals of the proposed research are to determine whether repeated exposure to a low sodium     food will result in reduced preference for salt in that food among children; and to determine     whether such reductions in preference are related to dietary intake of salt, taste receptor     genotype, and anthropometric and physiological measures.   "
28717|NCT02909751|"     The purpose of this study is to investigate whether tocotrienol can improve the effect and     reduce the side effects of standard chemotherapy before operation for breast cancer.   "
28718|NCT02909738|"     The investigators would like to test how well healthy human volunteers power a modified     oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a     bicycle instead of wall power so that it can be used in low resource countries where the     power supply is unreliable.   "
28719|NCT02909725|"     Multiple studies have demonstrated a very low prevalence of women meeting physical activity     and weight gain recommendations during pregnancy. Additionally, previous Blossom Project     studies have shown that when pregnant women engage in a 20 minute walk each day, they spend     significantly more time sitting in addition to longer bouts of sitting resulting in increased     total sedentary time. We are going to test which method works best to decrease sitting time,     and how those methods effect metabolic parameters such as insulin resistance and blood     glucose. This study will consist of three groups, each utilizing a commercially available     fitness tracker, Fitbit. Group 1 (SR): will reduce sedentary time by interrupting prolonged     sitting. Group 2 (WALK): will reduce sedentary time via walking. Group 3 (UC): will continue     on with their normal daily routine; usual care.   "
28720|NCT02909712|"     Sulfadoxine-pyrimethamine (SP) is currently recommended by the World Health Organization for     use as intermittent preventive treatment against malaria in pregnancy (IPTp) in areas of     moderate to high malaria transmission. However, in some locales malaria parasites have lost     sensitivity to SP, compromising its protective effect. Dihydroartemisinin-piperaquine (DP) is     a candidate replacement for SP. This trial is designed to confirm the cardio-safety of DP     compared to SP amongst pregnant women in Tanzania.   "
28721|NCT02909699|"     This study will investigate how resveratrol (phenol present in red grapes, wine and peanuts)     can improve heart muscle function and ability of arteries to dilate in response to an     increase in blood flow in adults 65 years of age and older. Additionally, investigators will     look at how resveratrol can improve functioning of cells (cellular house-keeping) which can     be related to cardiovascular function.   "
28722|NCT02909686|"     The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic     inflammation that cannot be measured with typical techniques. The investigators will be     observing the effects of nine different botanical compounds (supplements) that are known to     suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give     the investigators information about what is wrong in people with GWI.   "
28723|NCT02909673|"     This study is a school-based cluster randomized trial of the 7th grade version of Fourth R, a     promising teen dating violence prevention program, with 30 ethnically diverse middle schools     (15 intervention schools, 15 control schools) in one of the nation's largest school     districts. Students (N = 3,375) will be the unit of analysis and studied prospectively     (baseline, [post-intervention], and annually for 3 years) to determine the impact of the     program by comparing students in intervention schools with those in control schools.   "
28724|NCT02909660|"     This study evaluates the efficacy and acceptability of two cognitive-behavioural     interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a     family accommodation reduction protocol vs. a novel support-seeking protocol. Half of     participants will be randomly assigned to participate in the support-seeking intervention,     whereas the other half will participate in the family accommodation reduction intervention.   "
28725|NCT02909647|"     Background: Three dimensional (3D) digital pre-operative planning software for osteosynthesis     of fractures was developed. To assess the usefulness of the 3D planning, we evaluated the     accuracy of the reduction shapes and selected implants in the patients with distal radius     fractures.      Methods: Thirty wrists of 30 distal radius fracture patients who underwent osteosynthesis     using volar locking plates were evaluated. Fifteen wrists were treated with 3D preoperative     planning as the plan group. The other fifteen wrists were treated with conventional     preoperative planning as the control group. Volar tilt and radial inclination were measured     after operation and compared with the healthy side wrist. In addition, preoperative planning     and postoperative reductions were compared by measuring the volar tilt and radial inclination     of the 3D images in the plan group. The intra-class correlation coefficient (ICC) values of     the radiological parameters between healthy side wrists and injured side wrists, between     preoperative planning and postoperative reductions were evaluated. For the accuracy of the     implant choices, the ICCs for the screw lengths between the preoperative plan and the actual     choices were evaluated in the plan group.   "
28726|NCT02909634|"     Currently, the number of patients having either permanent or temporary stomas placed is     increasing each year. Yet, patients with ostomy pouches often struggle with predicting when     stool output will occur and how to plan around dynamic changes in intestinal activity.     Ostom-I provides a real-time assessment of the volume in the ostomy bag, it does not predict     when and how fast such output will occur. In this pilot study the investigators aim to gather     normative AbStats and Ostom-I data in participants with an ostomy to improve prediction of     stool output.      Aim 1: To gather normative AbStats and Ostom-I data in subjects with an ostomy to improve     prediction of stool output.      Aim 2: Correlate the data from both wearable biosensors and test the predictive validity of     AbStats in determining ostomy bag filling as measured by Ostom-I.   "
28727|NCT02909621|"     This study is a prospective, randomized, double-blind, placebo-controlled with 3     parallel-groups and multicenter trial in patients suffering from knee OA (osteoarthrosis).      A first exploratory non comparative study (TILFLEXY002, NCT01909037, Henrotin et al., 2014     BMC Complementary and Alternative Medicine) evaluated the efficacy of FLEXOFYTOL® at the dose     of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee OA, on the serum     levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain and on     the global patient assessment of disease activity.      This study demonstrated a statistically significant decrease of sColl2-1 cartilage specific     biomarker, an early decrease of the ultrasensitive C-reactive protein (CRP), an improvement     of the global assessment of the disease by the patient as well as a good tolerance and     compliance for the treatment. Results of this exploratory study are encouraging and justify     the setup of a randomized, placebo-controlled double blind and dose-ranging trial.   "
28992|NCT02906163|"     Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha     1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy.      Phase II: evaluate the efficacy in terms of PFS of Thymosin alpha 1 in patients with advanced     EGFR mutant NSCLC taking SoC as compared to SoC alone.   "
28728|NCT02909608|"     Physical activity is an important factor in understanding how diseases can affect a child.     Decreases in physical activity are sometimes the first thing that happens before a child is     diagnosed with a disease. When a child sees their doctor, that visit reflects a single point     in time. It does not capture how a child feels during the days in between visits to their     doctor. This study plans to use special monitors called actigraphs to collect information     about physical activity in children with a type of disease called pulmonary hypertension.     This study will measure how active these children are and compare their activity to clinical     information and to actigraphy measurements in children without pulmonary hypertension.   "
28729|NCT02909595|"     Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the     preference for basket or balloon catheters for extraction is operator-dependent It is     reported that complete endoscopic treatment with a single catheter is more likely when     choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a     study comparing the two catheter types in patients with periampullary diverticulum has not     been performed, and there is no strong basis on which to recommend the balloon catheter as a     first-line stone removal device. The investigators therefore conducted a multicenter     prospective randomized trial to compare catheter performance in patients with periampullary     diverticulum.   "
28730|NCT02909582|"     Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus     exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin     incision placed above the pannus (should a pannus exist).   "
28731|NCT02909569|"     This study evaluates the effect of twice daily dose of INCB39110 in the treatment of itch in     adults.   "
28732|NCT02909556|"     Cinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic     Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval     purposes.   "
28743|NCT02909413|"     This study compares desflurane with sevoflurane for school-age children in postoperative     cognitive function.   "
29276|NCT02902445|"     The GASTROVIM research explores the links between individual genetic susceptibility, genetic     variability of rotavirus strains and effectiveness of immunization with the rotavirus     vaccination: a clinical investigation to assess glycan attachment specificity, toward     rotavirus vaccine improvement.   "
28733|NCT02909543|"     This research will focus on young women between the ages of 18-38 who underwent a heart     operation and their life experiences. This research will focus on these life events and the     paradigm of these women being raised as heart sick, and consequently lacking self-esteem     (Frigiola, Bull, & Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on the     quality of life compare men and women, completely ignoring women's body image and the     experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al.,     2013). This study aims to focus on women's stories about their life experiences and the     influence of surgery(ies) on their daily life using an the qualitative phenomenological     approach.   "
28734|NCT02909530|"     Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended     technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a     sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic     masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle     is usually responsible for the low yield of tissue samples for histopathological examination.     The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a     larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can     maximize tissue acquisition and sample adequacy, which is important for appropriate     diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with     pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge     needle. This is attributable to the technical difficulty to push the needle out of the     endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head     region, it is therefore particularly important to improve technical success in these cases.     The new 19-gauge biopsy needle Olympus EZ Shot3 Plus is more flexible than common biopsy     needles such as EZ Shot2 and should therefore provide improved access to regions like     pancreatic head. The aim of this multicenter prospective randomized crossover study is to     compare those two needles during EUS-FNB of solid pancreatic masses.      Therefore this study will enroll 40 patients in five German centers with solid pancreatic     masses and consecutive indication for EUS-FNB. Both needles will be used in each patient     following a predetermined random order.      Primary endpoint is the correct histological diagnosis of the mass assessed by each needle.     Technical failure is regarded as a negative histological diagnosis.      Secondary endpoints include a comparison of technical failure using each needle, histological     quality, duration of procedure and rate of adverse events.   "
28735|NCT02909517|"     This prospective, non-therapeutic study will determine whether a novel imaging technique can     identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.      In this study, we will modify the standard angiography protocol by having patients return     twice in the week following angiography for additional photographs. Photographs will be     obtained 2-7 days after angiography, but without further injection of dye. This technique     contrasts with normal angiography in which photographs are taken during the transit phase of     dye circulation and in the minutes thereafter. Of note, both the dye and the cameras used for     its detection have been approved for clinical use for several decades and are routinely used     in the evaluation of patients with ocular tumours.      We will evaluate 5 groups:        1. Choroidal nevus (low-risk features): requires distinction from melanoma through          diagnostic testing        2. Choroidal indeterminate melanocytic lesion (high-risk features): requires diagnostic          testing for identification and distinction from nevus and melanoma        3. Choroidal melanoma: requires confirmation of diagnosis and evaluation for potential          metatstases        4. Suspected metastatic tumour (ie, primary tumour elsewhere): requires identification of          primary tumour        5. Locally treated ocular tumours: requires followup to evaluate response to treatment and          potential change or repeat therapy   "
28736|NCT02909504|"     This study is a 4-month open-label study of lithium in the acute treatment of patients with     bipolar I or II disorder. Eligible patients will receive lithium 300 mg twice daily and     titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L. Blood samples     are collected at baseline and at the end of study. Analyses of 45 molecule expressions in     mononuclear blood cells at baseline and endpoint will be carried out after the completion of     study. Fifty patients meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)     criteria for bipolar I or II will be enrolled.   "
28737|NCT02909491|"     The primary objective of this study is to determine whether geriatric inpatients with severe     behavioral disorders exhibit higher serum ionized calcium concentration than geriatric     inpatients without behavioral disorders, but no difference in serum calcium or corrected     calcium concentrations. The secondary objective of this study is to determine whether the     serum ionized calcium concentration is associated with behavioral and cognitive performance     among geriatric inpatients.   "
28738|NCT02909478|"     Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and     dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea     and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the     efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to     prevent both acute and delayed nausea and vomiting induced by chemotherapy. However,     multi-period use of dexamethasone could be associated with side effect, such as     hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic     therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone     plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with     colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.   "
28739|NCT02909465|"     Ketamine is the cornerstone of procedural sedation in emergency department but ketamine     induced agitation has limited its usage by many physicians. As a solution, some propose using     midazolam or haloperidol before ketamine injection. In this randomized double blind clinical     trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first     group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol     and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1     mg/kg). The patients are assessed for agitation during and after the procedure the     clinician's satisfaction with sedation instrument is evaluated after the procedure.   "
28740|NCT02909452|"     The objectives of this study are to explore different dosing levels and schedules of     entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms     of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and efficacy   "
28741|NCT02909439|"     This study will compare patient recovery measures after reversal of neuromuscular blockade     with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle     strength, time to extubation and quality of recovery in the post anesthesia care unit.   "
28742|NCT02909426|"     Mammography screening has limited performance in young women or women with dense breasts     although it is the only proven method for breast cancer screening that reduces the mortality.     The investigators propose a multicenter trial of breast cancer screening to assess the     effectiveness of supplemental ultrasonography for Korean women aged 40-59 years.   "
28744|NCT02909400|"     Mitochondrial Diseases are rare, progressive, multi-system, often-early fatal disorders     affecting both children and adults. KH176 is a novel chemical entity currently under     development for the treatment of inherited mitochondrial diseases, including MELAS     (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), MIDD     (Maternally Inherited Diabetes and Deafness), Leigh's Disease and LHON (Leber's Hereditary     Optic Neuropathy). The current Proof of Concept study aims to explore the effects of     treatment with KH176 for 4 weeks on clinical signs and symptoms and biomarkers of     mitochondrial disease and to evaluate the safety and pharmacokinetics of KH176 in patients     with m.3242A>G related mitochondrial disease.   "
28745|NCT02909387|"     Specific Aim 8. Evaluate the efficacy of Project UPLIFT for reducing symptoms of anxiety,     depression, and PTSD among African Americans at immediate posttest, after 3 months, and after     5 months.   "
28746|NCT02909374|"     Fall is one of the most common causes of ill health and morbidity in the older population. In     Sweden about 300 000 people/year seek emergency treatment due to falls and out of these 1600     dies. Poor balance control leads to a sedentary life with muscle weakness, fear of falling     and an increased risk for falls. Balance training and physical activity have positive effects     on fall prevention and balance, but long-term follow-ups are limited. There is also a gap     between what has been proven to be efficient in research and what is performed in communities     and clinical settings.      Many studies reports on the efficacy of certain treatment, method or training program, which     often may have taken years to develop, but few of these results are taken further into     clinical practice and it may take years for them to come into daily use. This delay means     that there is a gap between what is known and what is consistently done. It if of importance     implement methods that have been proven to have beneficial impact on health and physical     function in a clinical trial. Furthermore to evaluate which strategies for implementation     that are of significance. The aim of this study is to implement evidence based balance     training into clinical practice to prevent future falls and fall-related injuries in older     adults.      The program has been proven to be efficient, but not yet been implemented in the community     and clinical settings. Implementation outcomes will include effectiveness, acceptability,     feasibility, fidelity, cost and sustainability. Outcome variables on individual level will be     fall-related concerns, balance performance, physical function and activity, health related     quality of life and number of falls.      The investigators foresee that this balance training for older adults will prevent future     falls and fall related injuries, increase physical activity level, health related quality of     life and provide the participants with a strategy to be able to have a physically active and     healthy life style.   "
28747|NCT02909361|"     Fulvestrant 500mg in Patients With Advanced Breast Cancer   "
28748|NCT02909348|"     There is a new form of cancer treatment called immunotherapy which does not attack cancer     directly but works on the immune system to make it more effective. This type of treatment may     have side effects which are called autoimmune side effects and are caused by the immune     system attacking the normal parts of the body. At the moment doctors cannot predict which     patients may be at more risk of developing such autoimmune side effects and doctors also     cannot predict which patients are more likely to benefit. This study will analyse blood     samples from patients receiving immunotherapy to see if markers can be identified to help     make such predictions.   "
28749|NCT02909335|"     Tacrolimus is a calcineurin inhibitor. This is the immunosuppression of reference for     patients undergoing a first liver transplant. This treatment can prevent graft rejection, but     can cause side effects including kidney failure (in 25% after the first year).      Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and     kidney transplant recipients. It preserves renal function when it is started soon after the     transplant, i.e. before a severe dysfunction is installed.   "
28788|NCT02908828|"     Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton     species in the marine food web in the Norwegian Sea. Copepods constitute the largest     renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now     developed knowledge and technology for sustainable harvesting of this new resource. The     purpose of this study is to investigate whether Calanus copepod oil supplementation has an     equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in     mice.   "
28790|NCT02908802|"     Subjects will answer the following questionnaire and tests:        -  Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)        -  Demographic Questionnaire - composed by the researchers        -  Family Eating Habits Questionnaire (FEAHQ-33)        -  Food Frequency Questionnaire (FFQ)        -  Test MOXO      The subjects will take the study product for six months.      After six months the subject will fill once again all the questionnaires.   "
28750|NCT02909322|"     The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions     routinely use continuous epidural analgesia (CEA) for pain control in this patient     population. A functioning CEA provides adequate analgesia, but is associated with high     failure rates (20-30%) and sometimes significant hemodynamic disturbances (hypotension)     requiring an increased amount of intravenous fluid and blood products to maintain     homeostasis. Furthermore, its safety has been the subject of debate in liver resection     patients due to the elevated risk of epidural hematoma and its serious neurological     consequences. These limitations highlight the need to explore other options for analgesic     control after hepatectomy, such as paravertebral block (PVB). PVB has been shown to provide     similar analgesia with a lower incidence of pulmonary complications, side effects (pruritis,     urinary retention, nausea and vomiting, hypotension), and failure rates (6.1%) when compared     to CEA in thoracic surgery, and therefore has been suggested as a safer alternative in     hepatectomy patients. Despite this, there are no studies comparing the efficacy of CEA and     PVB as analgesic techniques after hepatectomy. The investigators propose a randomized     controlled trial to compare the analgesic efficacy, side effects, and complications     associated with CEA and PVB in patients undergoing elective hepatectomy through a right     subcostal incision.   "
28751|NCT02909309|"     Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea     During Sedation With Propofol in TCI Mode   "
28752|NCT02909296|"     The pancreatic surgery causing some pancreatic collections. And in a number of case, this     surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage.      The endoscopic care of the treatment of pancreatic collections post-surgery is not yet     standardized.      After failure of the medical treatment, the drainage of collections by echo-endoscopy was     described.      There are not much series on this specific subject. Only 2 series contain more than 20     patients with 31 patients for the most important.      The timing and the technical choice of the endoscopic treatment as well as the long-term     follow-up are not clear.      The purpose of this study is to estimate the success and the complications of the endoscopic     drainage by echo-endoscopy according to the techniques of drainage and the timing of the     endoscopic treatment.      The not estimated long-term follow-up will be also considered.   "
28753|NCT02909283|"     The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at     the microcirculatory level in children with sickle cell anemia (SCA) using combined novel     investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance)     imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological     properties.   "
28754|NCT02909270|"     A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy     and safety of adhesion barrier Mediclore versus no treatment in patients with total     thyroidectomy   "
28755|NCT02909257|"     Femoral nerve blocks are commonly used to provide pain control for total knee replacement,     anterior cruciate ligament (ACL) reconstruction. Commonly employed local anesthetic     concentrations result in motor block of the quadriceps and constitute an inherent risk factor     for patient fall.      The aim of this study is to determine the minimum effective concentration of bupivacaine in     90 % of patients (MEC90) required for a motor-sparing, successful sensory block of the     femoral nerve.   "
28756|NCT02909244|"     Some Primary Immune Deficiencies can be associated with an inflammatory bowel disease,     mimicking Crohn disease : the Chronic Granulomatous Disease (CGD), the XIAP deficiency, and     the TTC7A deficiency.      This inflammatory bowel disease is frequent but inconstant, raising questions about other     factors contributing to the disease. The aim of our study is to analyze, describe and compare     the gut microbiota of patients with those primary immune deficiency, with or without     intestinal disease.      The investigators can expect, in the long term, to compare on a same patient, the gut     microbiota evolution, and to assess the role of gut microbiota modifications on the onset of     an inflammatory bowel disease.   "
28757|NCT02909231|"     This study evaluates the three, six, and twelve month patient reported outcomes of people     admitted two trauma centres in western Canada over a four month period. Participants are     evaluated using the Trauma Outcome Profile and a custom survey instrument.   "
28758|NCT02909218|"     The purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes,     affordability, and scalability of offering early antiretroviral treatment to all HIV-positive     individuals in Swaziland's government-managed health system.   "
28759|NCT02909205|"     The aim of the study is to improve care practice related to gastrostomy management. This a     before-after study, aimed at evaluating knowledge of care givers, families and patients about     gastrostomy management. The intervention includes 1) A training in a care protocol for     hospital care givers, and 2) A booklet for patients, families, and outpatient care givers.     The evaluation criterion is a questionnaire to assess knowledge of hospital care givers,     patients, families, and outpatient care givers.   "
28760|NCT02909192|"     Disruption of sleep and alertness is one of the most disabling non-motor symptoms of     Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not     well understood, and treatment options remain limited. The proposed research will examine     markers of the circadian system, sleepiness and sleep quality in PD patients. Further, the     project will examine effects of bright light exposure on circadin function, sleep and     alertness in PD.   "
28761|NCT02909179|"     The purpose of this community-based randomized controlled trial is to test whether the     mCARE-II intervention package, delivered by the existing Government of Bangladesh community     health workforce, will improve neonatal and perinatal survival in a rural setting in     northwestern Bangladesh. mCARE-II is a digital health intervention, which incorporates     automated workload scheduling, client prioritization and risk stratification, overdue service     reminders and demand generation through client side reminder messaging. The intervention     package focuses on the pregnancy and early postpartum period.   "
28762|NCT02909166|"     The aim of the study is to find out whether aliskiren reduces atrial fibrillation burden     measured with a pacemaker device   "
28763|NCT02909153|"     The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration     (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered     intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).     It is an open label, dose escalation study.   "
28764|NCT02909140|"     Obtaining appropriate mydriasis prior to cataract surgery is an important variable in     successful surgery. The current practice includes using topical anticholinergic and     sympathomimetic agents in the preoperative area prior to cataract surgery, but the pupils are     sometimes insufficiently dilated and can often need additional mydriasis with intracameral     agents during cataract surgery. Pre-operative topical mydriatic drops take time to take     effect, are mildly uncomfortable for the patient, and have a cost to the healthcare system.     If intracameral mydriasis alone can achieve adequate pupil dilation, perhaps topical     mydriatics would not be needed. The purpose of this study is to evaluate whether topical     versus intracameral versus topical + intracameral mydriasis is the optimal way to dilate     pupils during routine cataract surgery. The results of this study have implications for     improving the efficiency and reducing time prior to cataract surgery. In addition, it has     significant potential to reduce the cost associated with cataract surgery if preoperative     drops can be eliminated.   "
28765|NCT02909127|"     There is no dysphagia spesific and patient/parent centered outcome instrument in the     pediatric population. The purpose of this investigation is to develop the Pediatric version     of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.   "
28766|NCT02909114|"     Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer   "
28767|NCT02909101|"     The purpose of this study is to examine the effects of a cognitive training program in     persons with Human Immunodeficiency Virus (HIV) infection who have used cocaine. This study     tests the feasibility and preliminary efficacy of a computerized cognitive training program     to improve working memory and decrease impulsivity (delay discounting) among HIV-infected     individuals.   "
28768|NCT02909088|"     The primary objective of this study is to evaluate the efficacy and tolerability of ecopipam     in reducing stuttering symptoms.      It is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the     SSI-IV total score, the CGI, SSS and OASES.   "
28769|NCT02909075|"     The purpose of this study is to see if a positron emission tomography/computed tomography     (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the     thymus size and function. The researchers would like to monitor the thymus with a PET/CT scan     and a MRI before and after the participants transplantation.   "
28770|NCT02909062|"     Electronic activity monitoring (EAM) devices are wearable electronic devices that monitor     functional activity and provide personal feedback on activity progression. This study aims to     determine if EAM can provide an objective, assessment of patient functional activity. The     study will also examine the change in functional activity experienced by patients during the     first cycle of chemotherapy. Another objective of the study will be to see if baseline     functional activity and the change in functional activity that occurs during the first cycle     of chemotherapy can be used to predict patient tolerability of subsequent cycles of     chemotherapy.   "
28771|NCT02909049|"     To assess the effectiveness of two anesthetic techniques by measuring the pain through visual     analog scale (VAS), to obtain saturation prostate biopsies.   "
28818|NCT02908438|"     The study was designed to investigate the effect of luteal-phase administration of     gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro     fertilization-embryo transfer.   "
28772|NCT02909036|"     Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan     chemotherapy that in packaged in an inactive substance that is believed to help the     chemotherapy be more stable (meaning that it doesn't lose its effect or need to be     administered quickly after being mixed). It may also have fewer side effects such as problems     with important levels of body electrolytes such as potassium, phosphorous and magnesium; and     cause less kidney and heart damage] than standard formulation melphalan.      The purpose of this study is to determine if the investigators can achieve a certain level of     Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL     Amyloidosis.   "
28773|NCT02909023|"     Activation of the immune system against a pathogen can be considered one of the most     effective interventions in the field of infectious diseases.      Transgene is developing a therapeutic vaccine TG1050 for the treatment of patients with     chronic and treated Hepatitis B. This biotherapy compound is for the development of T     cellular immune response in these patients in order to achieve the total elimination of     infected cells.      Therefore it is necessary to have measures of ways to assess accurately and reliably the     presence of such a response in the study subjects.   "
28774|NCT02909010|"     A randomized, control trial to compare the total dose of sedatives use in patients over 65     years admitted to the intensive care unit, guiding sedation by monitoring with BIS® versus     monitoring with the exclusive use of sedation scales.      The study will include all patients over 65 years who enter the intensive care unit of the     University Hospital of Bellvitge affected with medical or surgical pathology of non     neurological etiology who require sedation for more than 24 hours to maintain adaptation to     mechanical ventilation.   "
28775|NCT02908997|"     A study to investigate the effectiveness of a reminder tool application at increasing     performance on memory tasks in people with mild dementia   "
28776|NCT02908984|"     In part 1 of the project clinical efficacy of specific neck rehabilitation will be compared     with standard primary health care among patients with cervicogenic headache and study whether     fear avoidance beliefs and self-efficacy predict long term neck function and headache     frequency superior to active range of neck movement. Part 2 will investigate whether patients     with cervicogenic headache have changes in cerebral grey and white matter and in connectivity     of the resting state state network, whether these are reversed after effective neck     rehabilitation, and correlate to symptom severity and degree of disability.   "
28800|NCT02908672|"     This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study     designed to evaluate the efficacy, safety, and pharmacokinetics of combination of     atezolizumab (ATZ), cobimetinib and vemurafenib compared with combination of ATZ placebo,     cobimetinib and vemurafenib in participants with previously untreated BRAFv600     mutation-positive metastatic or unresectable locally advanced melanoma.   "
28993|NCT02906150|"     Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus     cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC),     EGFR wild type   "
28777|NCT02908971|"     Background: Children in industrialized and developing countries have a higher tendency to     present earlier signs of puberty. One hypothesis includes the hormonal effects of     phytoestrogens found in soy products.      Objective: to examine the association between consumption of soy-based food in early infancy     and childhood and the incidence of early or precocious puberty and overweight in school-aged     children.      Methods: the study population for this case control study is randomized from a prospectively     followed cohort of all babies born at Assaf Haroffeh medical center and followed for milk     allergy signs and food intake until the age of 3 years (A nested cohort). It is divided to     those who were allergic to milk, and thus consumed only soy based formula and food during     infancy and childhood (soy group) and a randomized control group who consumed non-soy based     intake. For both groups data are available of food habits during infancy and collected from 3     days food diaries during the current study. Physical examination, including weight , height,     blood pressure and Tanner Pubertal Staging will performed annually.   "
28778|NCT02908958|"     To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the     treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of     population of children.   "
28779|NCT02908945|"     Monitoring the brain using electroencephalography (EEG) during general anesthesia provides     the anesthesiologist with valuable feedback of how deeply anesthetized their patient is,     reducing the chances of under- or overdosing and potentially improving patient outcomes.     However, commercial EEG monitors that output processed EEG (pEEG) were developed under     carefully controlled, simple anesthetic regimes - in contrast to the multimodal cocktail of     drugs often used in clinical practice. Ketamine is one potential adjunct to a standard     anesthetic, which has a growing body of evidence suggesting that it may improve     post-operative outcomes. The effects of ketamine on pEEG parameters are poorly understood.     This randomized, open-label, feasibility study will be undertaken in a sample of 30 adult     outpatient surgery patients. The primary objective is to observe the intra-operative raw and     pEEG trends using the NeuroSENSE monitoring system in patients receiving one of two different     analgesic doses of ketamine, compared to patients not receiving ketamine, during an otherwise     comparable general anesthetic. Secondarily, we will consider other clinical data of interest     from both intra- and post-operative contexts in order to establish a broader understanding of     the potential influence of two analgesic ketamine doses on anesthetic depth and     post-operative outcomes. Feasibility outcomes will be assessed with the ultimate goal of     developing a larger-scale clinical trial.   "
28780|NCT02908932|"     The goal of this study is to determine if supplementation with krill oil concentrate     containing the phospholipid-bound omega-3 fatty acids improves performance on specific     cognitive tests that underlie key elements in U.S. Army Infantry Basic Officer Leaders Course     (IBOLC) and in Ranger School (Training) at Fort Benning, GA.   "
28781|NCT02908919|"     The purpose of this study is to determine optimal time intervals for preparation before     colonoscopy using different formulas.   "
28782|NCT02908906|"     The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for     JNJ-63723283 in Part 1 and to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s)     in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC),     melanoma, renal, bladder, small-cell lung cancer (SCLC), and gastric/esophageal cancer in     Part 2.   "
28783|NCT02908893|"     The investigators design a 6-week messaging campaign aimed at promoting flu vaccination among     fully insured members of a national payer that participate in a wellness program offered by     the insurer through a mobile app. Outcomes measured will include uptake in flu vaccination     rate as measured by the insurer and engagement with the campaign through the app.      The goal of the research is to assess the effectiveness of pervasive computing messaging in     promoting preventative care treatments such as flu shots. An additional goal is that of     quantifying the importance of emphasizing incentives to increase efficacy of the messages.   "
28784|NCT02908880|"     Research study which tests the safety and effectiveness of a new vascular closure device to     close the femoral access puncture that is created in patients who require this form of access     in order to perform the planned procedure. The MANTA device is expected to seal the femoral     access puncture in less than 1 minute. This may result in less blood loss and a shorter time     to walking compared to alternative closure means. Use of the MANTA device in this study is     experimental. All other parts of the procedure involve standard medical care.   "
28785|NCT02908867|"     Objectives: To know the main therapeutic strategies used by men with spinal cord injury in     sexual dysfunctions.   "
28786|NCT02908854|"     A two-phase, school-based intervention will be conducted at a high school in Baltimore to     evaluate whether the addition of spices and herbs to vegetable dishes in the National School     Lunch Program (NSLP) can increase vegetable intake among students in an urban and     predominantly African-American high school.   "
28787|NCT02908841|"     Surgicel Snow is an FDA approved topical hemostatic agent for use during surgical procedures.     Like the other mechanical agents, Surgicel Snow forms a physical barrier that blocks blood     flow while providing a large surface area for the rapid formation of a fibrin clot. As a     mechanical agent derived from oxidized regenerated cellulose, Surgicel Snow shares with other     mechanical hemostatic agents, the benefits of a favorable risk profile. This study would     examine the efficacy of Surgicel Snow vs. direct compression in the control of capillary,     venous, and small arterial hemorrhage when ligation or other conventional methods of control     are impractical or ineffective in patients undergoing laparoscopic or robotic assisted     laparoscopic hysterectomy. The intraoperative inclusion bleeding characteristics are minimal     and mild retroperitoneal bleeding and moderate retroperitoneal bleeding that has been     adequately reduced by standard surgical methods. 60 patients will be recruited for this     study, all of which will be scheduled for hysterectomy at Western Connecticut Health Network     (Norwalk Hospital and Danbury Hospital) under the direction of Dr. Thomas Rutherford, Dr.     John Garofalo, and Dr. Robert Samuelson. The investigators will randomize 30 patients to the     treatment group and 30 patients to the control group. Participants may continue all regular     medications before and during the study. The consent process will be incorporated into the     last pre-operative office visit. The health risks associated with use of Surgicel Snow may be     less, the same or more than direct pressure alone. Surgicel Snow is generally used for     minimal to mild bleeding from specific or widespread area; however, its effectiveness     compared to direct pressure is unknown for a hysterectomy surgery.   "
28791|NCT02908789|"     This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in deep     carious lesions. This is an in vivo study approved at the Research Ethics Committee, which     will be conducted in 30 patients between 3 and 12 years. Patients included in the study     should have at least one primary molar or permanent with deep active caries limited occlusal     / proximal surfaces involving beyond the inner half of dentin. The investigators will     considered from exclusion criteria children whose parents refuse to sign the informed consent     document; children who do not cooperate with the clinical examination/treatment; children     with syndromes or chronic systemic diseases; teeth with painful symptoms consistent with     irreversible pulpitis or mobility; periodontal changes; roots with pathological resorption;     cases of primary teeth roots in advanced stage of physiological resorption and patients that     have made the use of any antibiotics during the study period or within three months prior to     its beginning. The treatments will be carried out after local anesthesia and isolation of the     operative field with a rubber dam. The removal of carious dentin surface demineralized     necrotic and not subject to remineralization will be held with drill at low rpm under cooling     with sterile saline. The removal of decayed tissue will start by the side walls and later on     the pulp wall. After this time the intervention with aPDT using 0.01% methylene blue as     photosensitizer will be held. Finally, the cavity is restored with adhesive and composite     resin system. The dentin samples will be collected with the help of spoon sterile dentine in     two stages: C1 after digging and C2 after aPDT. The microbiological analyzes will be     conducted with counting of colony forming units (CFU / mg of carious dentin), blindly from     coded samples. The viability of microorganisms will be evaluated in the following culture     media: Brain Heart Infusion agar for feasibility total microorganisms; CHROMagar candida to     Candida genus; Mitis Salaviarius agar with addition of bacitracin 0.2 U/mL, sucrose and     glucose to Streptococcus mutans; Mitis Salivarius agar to total Streptococcus; Rogosa Agar to     Lactobacillus spp. and enterococcosel for Enterococcus genus. The reproducibility of the     counting method will be verified between triplicates. Microbiological data will be evaluated     with appropriate statistical tests with a level of 5%. Based on this project is expected to     prove the clinical efficacy of aPDT using 0.01% methylene blue as an adjunct in reducing of     microorganisms from interior of deep carious lesions contributing to the clinical and     radiographic success.   "
28792|NCT02908776|"     MYDA-MI study is a randomized, placebo controlled, double blind study performed in San     Filippo Neri Hospital, Roma, Italy. The planned study duration is 18 months. The objectives     are to assess the effects of pre-treatment with probiotic Ecoviesel on the incidence and     magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable     patients. 250 patients with chronic stable angina scheduled for a coronary angiography and     possible ad hoc angioplasty will be randomized to receive pre-treatment with Ecoviesel     sachets (each sachet contains 200 billions bacteria) or Placebo. The pre-treatment dosage     will be 4 sachets of probiotic Ecoviesel or placebo for at least 2 weeks before the planned     procedure. In patients undergoing angioplasty the same treatment will be continued for 4     weeks after PCI with secondary outcome measures performed at the end of this second stage.   "
28793|NCT02908763|"     HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The     purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg     loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level     HBsAg.   "
28794|NCT02908750|"     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase     inhibitor (TKI) agent.      Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of     fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state.      Continuous Access will allow patients further access to osimertinib after the PK phase (Part     A). All patients from Part A who completed treatment may continue to receive osimertinib 80     mg once daily until: they are no longer deriving clinical benefit; or any other reason.   "
28795|NCT02908737|"     The clinical study is designed to evaluate the safety and effectiveness of recipient     controlled Bass and Treble.   "
28796|NCT02908724|"     The purpose of this study was to assess the progression of cardiac involvement in adult     patients with Fabry Disease (FD), in the unique Danish Fabry cohort and comparing those FD     patients receiving primary therapy vs. those that did not.      The hypothesis is, that we will not be able to see a significant positive difference in     cardiac involvement in those FD patient who received FD specific therapy vs. those that did     not.   "
28797|NCT02908711|"     Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal     analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1.     Perineural analgesia offers the advantage of extended pain relief up to 24 hours after     surgery2.      This is a prospective, randomized control trial designed to compare the analgesic efficacy of     the adductor canal block (ACB) performed immediately before or immediately after primary     total knee arthroplasty (TKA). The primary objective of this study is to measure pain score     associated with knee motion following TKA among patients receiving ACB as part of their     analgesic regimen for TKA. Secondary end points include assessment of postoperative     ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction     between the two analgesic approaches. The investigators hypothesize that ACB before the     surgery will reduce a patient's postoperative pain and improve patient satisfaction.      All consecutive patients undergoing primary TKA will be recruited for enrollment in the     study. Patients will be for randomized preoperatively to receive either preemptive ABC     (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will receive     the block prior to incision. Patients randomized to the PostACB group will receive the block     at the end of the surgery. Both techniques are in accordance to the standard of care at our     institute. All patients will have the ACB done by a regional anesthesiologist in the regional     anesthesia unit, or in the operating room. Patient medical history will be obtained and     blocks will be placed per usual protocol. Operative and anesthetic details, including     medications given, will be recorded.      Pain scores and pain medications given in the PACU will be recorded. Supplementary analgesics     will be provided per institutional PACU protocol. Study data will be recorded for up to 72     hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the orthopedic     follow-up appointment to evaluate the patient's late pain scores and overall satisfaction.     Data will be analyzed both at the conclusion of the study and at several intervals prior to     completion of the study.   "
28798|NCT02908698|"     Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy     lesions. The prevalence of AD has increased over the past few decades, with 15-30% of     children and 2-10% of adults being affected. The lesions of atopic dermatitis patients are     very inflamed, with an increased number of inflammatory cells in the skin. The first line     treatment for AD is steroids, which reduce inflammation in the skin. There are several ways     to measure if the treatment is effective, including clinical and cellular. We are proposing     that a controlled skin allergen challenge will be an effective way to measure the effect of     steroid at a cellular level through the measurement of inflammatory cells in the late     cutaneous response. This will be examined using a placebo-controlled trial.   "
28799|NCT02908685|"     Multi-center, randomized, double-blind, placebo-controlled, Phase II study to assess the     safety, tolerability, pharmacokinetic, pharmacodynamics, and efficacy of RO7034067 in adult     and pediatric patients with Type 2 and Type 3 spinal muscular atrophy (SMA). The study     consists of two parts, an exploratory dose finding part (Part 1) of RO7034067 for 12-weeks     and a confirmatory part (Part 2) of RO7034067 for 24-months.   "
29687|NCT02897089|"     The purpose of this study is to evaluate and compare the clinical retention of a resin-based     fissure sealant placed with prior application of etch-and-rinse and self-etch modes of     universal adhesives.   "
28801|NCT02908659|"     In ICU setting, a large number of medical devices are attached to patients, generating     numerous alarm signals. Several studies have demonstrated that most of these alarms are not     clinically relevant and tend to lower the attentiveness of healthcare professional and, in     turn, lower patient safety.The aim of the study is to assess the relevance of respiratory     rate alarm on a monitoring device in non-ventilated ICU patients.      The investigator primary hypothesis is that this alarm is potentially useless. If this     hypothesis is confirmed, a second interventional trial will be conducted on the impact of     this alarm removal.   "
28802|NCT02908646|"     Both of microcoil localization and hookwire localization have been proved as good     preoperative CT(computed tomography)-guided techniques to guide VATS resection for the     diagnosis of small peripheral pulmonary nodules technique to guide VATS resection for the     diagnosis of small peripheral pulmonary nodules. The objective of this study is to determine     if microcoil localization for pulmonary nodules can be safer than hookwire localization   "
28803|NCT02908633|"     It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty:     ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat     Glaucoma and Cataract. It is a Randomised, Prospective Study.   "
28804|NCT02908620|"     The purpose of this study is to determine if the topical application to cheek tissue of the     combination of benzocaine and tetracaine has a longer duration of local anesthetic activity     than benzocaine alone.   "
28805|NCT02908607|"     When screening results for cervical premalignant lesions are positive, colposcopy is     recommended. This is highly sensitive screening method. However, specificity of the test is     of low.      Thus, a technology that improves the accuracy of the colposcopic exam is needed.      This is a feasibility study with the goal of examining the performance of a thermal imaging     camera in the detection of cervical malignant and premalignant lesions.   "
28826|NCT02908334|"     In this study patients will be randomized 1:2 to receive either standard of care treatment or     standard of care + Sertraline 200mg/day for 2 weeks, then 400 mg/day for 50 weeks for     treatment of disseminated and meningeal coccidioidomycosis.   "
28940|NCT02906839|"     The main aim of this project is to assess the effect of Sleep apnea syndrome (SAS) screening     (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index >15 / h) on     recurrence of atrial fibrillation (AF) over a twenty-four month follow-up period, in patients     on optimal medical treatment after AF ablation.   "
28806|NCT02908594|"     Aim. To investigate the effect of an intradialytic aerobic and resistance cycling exercise     program (IARCEP) on depression, fatigue, and quality of life (QOL) in end-stage renal disease     (ESRD) patients receiving haemodialysis, and further determine the effect of mediation     through self-efficacy and resilience in patients receiving the IARCEP.      Background. Depression and fatigue are common in ESRD patients undergoing haemodialysis,     which negatively affects their QOL. Exercise can mitigate this effect. Patient's     self-efficacy and resilience may be crucial mediators in exercise.      Design. This study was a randomised controlled trial. Method. Seventy-six participants were     randomly assigned to either a control or exercise group. Both groups received routine care;     whereas the exercise group participated the 3- months IARCEP. Data were collected at     baseline, the first, second, and third months, over a 14 months in 2013-2014.   "
28807|NCT02908581|"     This study will be conducted to observe any change in fungal pattern on skin of arsenicosis     patients before and after administration of iron (150 mg) and folic acid (0.5 mg) tablets.   "
28808|NCT02908568|"     Study over muscular stretching to reduce pain the oral cavity.   "
28809|NCT02908555|"     The purpose of this exploratory study is to evaluate the characteristics of sleep,     perceptions of barriers and facilitators to adequate sleep, and the associations among sleep     characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and     adjustment in adolescents with type 1 diabetes. A mixed methods approach that includes a     quantitative component, consisting of actigraphy and sleep diaries, questionnaires, tests of     executive function and continuous glucose monitoring (CGM) as well as a narrative qualitative     component will be used. Results from this pilot study will be used to provide the effect     sizes needed for a larger-scale descriptive study and to establish the need for a possible     sleep-promoting intervention for adolescents with type 1 diabetes. This project is consistent     with ongoing research focused on developing preventive, behavioral interventions for youth     with type 1 diabetes and their families to improve physiological (i.e., glycemic control) and     psychological (i.e., quality of life) outcomes. Sleep promotion may become an important     component of these interventions. Thus, the following specific aims will be addressed:        1. Describe the objective and subjective characteristics of sleep (duration, continuity,          bed time/rise times); sleep quality and sleep habits among adolescents with type 1          diabetes.        2. Explore the relationship between characteristics of self-reported sleep (i.e., habits,          duration, daytime sleepiness) and executive function, coping, adherence, and adjustment          (i.e., depressive symptoms, quality of life) in adolescents with type 1 diabetes.        3. Explore the relationship of glucose excursions on sleep characteristics and executive          functioning.      3. Conduct a qualitative study using narrative analysis with adolescents to identify     perceived barriers, facilitators, and consequences associated with insufficient sleep in     adolescents with type 1 diabetes.   "
28810|NCT02908542|"     Hypercalcemia, whether chronic or acute, exposes the patient to potentially serious     complications (arrhythmias, nephrolithiasis, nephrocalcinosis, ...). Prevention relies     primarily on effective etiological necessary for taking matched load. Under the French     reference center for rare disorders of calcium and phosphorus, the investigators looked for     mutations in the coding sequence of the CYP24A1 gene (encoding the enzyme responsible for the     breakdown of vitamin D), among patients with hypercalcemia without hyperparathyroidism with     hypersensitivity to vitamin D. However, only 25% of these patients have a genetic anomaly     suggesting the involvement of other genes (Molin et al. 2015). Recently our team, combined     with Kaufmann et al. (2014 JCEM) validated the interest of the determination of metabolites     of vitamin D by liquid chromatography-tandem mass spectrometry (LC-MS / MS), as biological     pre-screening stage for patients with hypercalcemia.      The objective of this project is to complement the molecular and biochemical studies of     patients without mutation of the coding sequence of CYP24A1, in a gene candidate approach     using massively parallel sequencing (MPS) which allows to study a panel of gene potentially     involved in disorder of metabolism of calcium and phosphorus. Highlighted variations will be     tested in silico, and if possible in vitro. The investigators will also use LC-MS / MS to     evaluate in vivo the effects of these variations on the metabolism of vitamin D, to develop a     genotype / phenotype correlation.      The work carried out within the Genetics Department Caen University Hospital in collaboration     with physicians of the rare disease reference center of the metabolism of calcium and     phosphorus should identify new genetic mechanisms underlying hypercalcemia. At the time of     development of personalized medicine, it will adapt the therapy in patients at risk for     metabolic complications and / or kidney following administration of vitamin D and finally to     offer genetic counseling.   "
28875|NCT02907697|"     Many people living with HIV use illicit drugs, which leads to worsened health outcomes and     increased transmission of HIV due to poor adherence to medication regimens. This research     will develop an intervention targeting medication adherence that is tailored to the unique     needs of HIV-infected drug users. This research will promote adherence and improve treatment     outcomes among HIV-infected drug users thereby minimizing the development of drug resistant     strains of HIV and reducing transmission.   "
28811|NCT02908529|"     Obstructive sleep apnea (OSA) is common and has major health implications but treatment     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared     to normal subjects. Until recently, the search for medicines to activate pharyngeal muscles     in sleeping humans has been discouraging. However, exciting new animal research has shown     that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle     activity to waking levels. In this protocol the investigators will test the effect of     atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug)     administered together on OSA phenotype traits and OSA severity during sleep.   "
28812|NCT02908516|"     The primary objective of this study is to assess the safety and efficacy of Tranexamic acid     (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip     fractures. In addition to assessing blood loss in these patients, complications associated     with TXA use would be characterized including systemic (pulmonary embolism, deep venous     thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events,     need for re-hospitalization or re-operation and 30 day mortality.   "
28813|NCT02908503|"     The purpose of this study is to evaluate use of four different vaginal films - two sizes and     two textures. The vaginal films have no active ingredients or medications. Information will     be gathered about each film (i.e. ease of insertion, proper placement, opinions about each).     The results of this study will help investigators determine which type of vaginal film to use     (and how to write product instructions) for future studies.   "
28814|NCT02908490|"     The purpose of this study is to determine whether sildenafil improves parameters of vascular     function and blood markers involved in development of heart disease in patients with     rheumatoid arthritis.   "
28815|NCT02908477|"     This study is designed for patients with a cancer of the oropharynx (tonsils or base of     tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks     of daily radiation therapy. This study investigates a less intense radiation treatment     following surgery that uses half the dose of radiation given over two weeks rather than six     weeks. Patients will be randomly assigned to receive the less intense treatment versus the     traditional treatment by coin flip. Patients are twice as likely to receive the less intense     treatment during randomization.   "
28816|NCT02908464|"     The purpose of this trial is to determine whether using a brain training program in the time     leading up to as well as after heart surgery will reduce confusion and cognitive loss that     can occur after surgery.   "
28819|NCT02908425|"     Statins are a class of drugs that are the most commonly prescribed medications in developing     countries. Statins act on the enzyme HMG-CoA reductase to inhibit its conversion to     mevalonate, a precursor for cholesterol synthesis. Subsequently statins are prescribed to     patients with relatively high blood cholesterol levels. However, taking statins does not come     without side effects. Most notably, the effects of statins on muscle wasting have been     studied extensively. This includes up-regulation of the ubiquitin proteasome system, muscle     cell damage and rhabdomyolysis, elevated creatine kinase, and mitochondrial dysfunction. Due     to the negative side effects of statin therapy, additional therapies are warranted to help     offset the effects on muscle wasting.      Loss of muscle mass is a significant concern as it is associated with a reduction in muscle     strength and power (Ferrando et al., 1996; Creditor, 1993). This condition is observed in     aging, disease states, and long periods of unloading such as hospital admission and can lead     to disability, increased falls, loss of independence, and mortality. Subsequently, there is a     critical need to develop interventions to counteract this loss of muscle mass and strength.     Exercise is one such intervention, however, in some cases may not be a feasible option. For     instance, exercise has been demonstrated to exacerbate the muscle side of effects of statins.     Subjects complain of increased muscle soreness and have elevated creatine kinase levels and     they also do not want to take statins anymore (Kearns et al., 2008; Parker et al., 2012;     Sinzinger et al., 2004). Because of this limitation, there is a critical need to develop     other interventions that can prevent the loss of muscle mass during statin use.   "
28820|NCT02908412|"     The decision to transfuse or not to transfuse blood products is one of the main issues in     patients undergoing surgery.      The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent     data, and requires venipuncture which is invasive and painful. In the past decade, the use of     non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the     patient's bedside, have become widespread. One of the tools that make this possible is     Spectrophotometric Hemoglobin.      However, one of the main concerns regarding this method is its accuracy. Since the accuracy     of this assessment depends on the extent of perfusion of the organ on which the probe is     placed, use of digital nerve blocks proposed to increase its accuracy.      This study aims to evaluate the effects of digital nerve block (with bupivacaine) on the     accuracy of non-invasive hemoglobin monitoring by spectrophotometry in patients undergoing     spinal surgery.   "
28821|NCT02908399|"     This is a prospective study of up to 250 participants, from birth to 18 months, who have     already had a chest x-ray while a patient at the National Institute of Health (NICH) in     Karachi, Pakistan. Participants will include both males and females as well as all races and     ethnicities. Participants will have thermal pictures of their chest taken by trained study     staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained     radiologists to determine if bacterial pneumonia is present. Results of the thermal image     will then be compared to the results of the chest x-ray. If additional images of the chest or     other areas of suspected related infection are available, additional thermal images will be     taken of the same location within 24 hours of the other image.   "
28822|NCT02908386|"     Given the lack of evidence for the benefit of particle therapy in relevant cases, he     investigators proposed an in silico trial to investigate the dosimetric effect of contour     changes for OAR as well as tumor during chemoradiation in H&N patients. Photon and     proton-therapy will be compared based on dosimetric data on 7 time points during treatment     combined with plan robustness. In that way the investigators will be able to assess and     compare the optimal timing for replanning for photon and proton therapy.      A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and     neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and     during RT (T1-T7)   "
28823|NCT02908373|"     The Réseau QualiSanté (risk management network) hardly works on risk management in nursing     homes. A model to help nursing homes managers to structure and analyze adverse events has     been constructed by a working group of health professionals in the Réseau QualiSanté. Several     questions appeared: is the model able to increase patient safety culture of professionals     working in nursing homes? How to characterize adverse events in nursing homes? How frequent     are they? The main objective of this research project EHPAGE is to measure the impact of the     model to structure and analyze adverse events in nursing homes on the patient safety culture     of professionals. The project combines quantitative data (questionnaire) and qualitative data     (interviews).   "
28824|NCT02908360|"     The prevalence of allergic diseases (atopic dermatitis, asthma, rhinitis, conjunctivitis and     food allergy) has increased dramatically in industrialized countries over the last 20-30     years.      Allergic diseases are present especially in children and young adults, but all age groups are     affected, with variations across countries and age. To propose new therapies, the     investigators must first understand the physiopathology.      Since their discovery the regulatory T cells have continued to be the subject of work to     understand their role in maintaining immune homeostasis in the human body but also their     involvement in autoimmune diseases, inflammatory diseases, transplants of solid organs or     fluids and allergic diseases.      It was identified two broad classes of regulatory T cells:        -  T cells = natural regulators acquisition of a phenotype and a regulatory function right          out of the thymus ( CD25 + / CD127 + low / FoxP3 +).        -  T cells induced regulators = acquisition of a phenotype and a regulatory function on the          periphery depending on the cytokine micro-environment.      Phenotypic characterization of these is less obvious and even more so than during the last     ten years several induced regulatory T cell populations have been described ( eg, Tr1 ).      A new subpopulation of T cells induced in patients with inflammatory bowel disease recently     identified have a particular phenotype as bearing the CD4 and CD8 double marking with a     regulatory phenotype.      These regulatory T cells are also induced a specific of a commensal intestinal bacterium     (Faecalibacterium prausnitzii).      Regarding allergies, it has been widely demonstrated a relationship between changes of the     intestinal microbiota and the occurrence of allergic diseases.      The investigators would therefore propose a cross-sectional study, single-center, controlled,     single blinded to study the role of T cells called double positive induced regulators DP8 to     compare the frequency and the regulatory function of specific DP8 of Faecalibacterium     prausnitzii in atopic dermatitis, asthma and allergic rhinitis compared to control samples.   "
28825|NCT02908347|"     This Phase IIa study is designed to assess the safety and tolerability of oral MP1032 in     patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to     evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week     follow up will provide an opportunity to perform a first assessment of oral MP1032's clinical     efficacy in the treatment of moderate to severe psoriasis.      The study population will consist of 44 enrolled (40 completed) patients with moderate to     severe chronic plaque psoriasis. Patients must be able to provide written consent and meet     all the inclusion criteria and none of the exclusion criteria.   "
28827|NCT02908321|"     Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the     disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way     that interferes with their wellbeing and every day functioning. In this project the     investigators will study the effect of the group program The Cool Kids Anxiety Program:     Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific     developed for children with ASD. The investigators expect a decrease in the overall anxiety     level together with an increase in the ability of handling anxiety.   "
28828|NCT02908308|"     ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after     out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at     33°C did not confer a survival benefit or improved neurological function, compared to TTM at     36°C. A lower target temperature might be beneficial compared with normothermia and early     treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any     differences in mortality, neurological function and quality of life between a target     temperature of 33°C and standard care avoiding fever.   "
28829|NCT02908295|"     Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women     undergoing myomectomy, both open and laparoscopic approach   "
28830|NCT02908282|"     The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing     Dry Eye Syndrome (DES) symptoms.   "
28831|NCT02908269|"     The aim of the study is to describe the safety and immunogenicity of the 2016-2017     formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults     18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in     adults ≥ 65 years of age.      Primary Observational Objectives        -  To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in          children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the          2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.      Observational Objectives:        -  To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent          vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the          immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65          years of age.        -  To submit available sera from approximately 90 subjects (30 subjects 3 to < 9 years of          age and 30 subjects 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine,          and 30 subjects ≥ 65 years of age who receive Fluzone High-Dose vaccine) to CBER for          further analysis by the WHO, the CDC, and the FDA to support formulation recommendations          for subsequent influenza vaccines.   "
28832|NCT02908256|"     An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the     intensive care unit and the mortality rate after a major surgery.      Different criteria are used to guide the optimal vascular filling of a patient. Among the     various monitoring for the last twenty years are parameters originating from the respiratory     variations of the arterial pressure curves and the pulse oximetry.      On arterial curves, the Systolic Pressure Variation (SPV) is the difference between the     maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen saturometry     curves obtained with the Masimo Radical7, the plethysmographic variability index (PVI)     corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the quotient     expressed in % between the pulsed infrared absorption signal and the continuous absorption     signal.      It has been demonstrated that the dynamic indexes were better than the static indexes to     determine the response to the vascular filling. A meta-analysis showed that the dynamic     changes of the variables derived from the arterial pressure curve of patients under mechanic     ventilation could predict the vascular filling responsiveness with a high specificity and     sensibility. The same thing applies to the variables derived from the pulsed oxymetry curves.      Furthermore, monitoring and minimizing, through the vascular filling, the variations of the     pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk     surgery allows to reduce the postoperative complications and the hospital length of stay.     This has not yet been proved for the non invasive parameters (IP and PVI).      The goal of this study is thus to compare a non invasive strategy (based on PVI) to an     invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic     interventions (digestive, gynecologic, urologic), in order to test their equivalence and     measure their impact in terms of hospital stay.      This record is linked to the NCT02709252 record and share the same cohort of patients.   "
28833|NCT02908243|"     Primary prophylaxis in severe hemophiliacs is defined that prophylaxis therapy starts before     2 years of age and prior to any clinically evident joint bleeding or after first joint     bleeding and prior to the onset of joint damage irrespective of age, joints can be kept     normal or very mildly damaged till teenage or adulthood. Primary prophylaxis has been proved     to be more beneficial and cause less damage to joint than on-demand therapy. Primary     prophylaxis is also known to be able to decrease the occurrence of factor VIII inhibitor and     is the most advanced and useful, cost-effective therapy for hemophilia care. However, it     requires 2 to 3 injections of factor VIII or IX of 20-50 IU/Kg doses every week, it costs a     lot of expenses. In the year 2013, we tried hard to discuss with Bureau of National Health     Insurance (BNHI) and have meeting a couple of time, eventually a guideline of an     intermediate-dose prophylaxis for severe hemophilia was established and a consensus was     reached that this prophylactic treatment will be cost effective without increased burden of     total budget. This guideline was finally approved by BNHI and will be implemented from July     1st, 2014. In oder to evaluate the efficacy of prophylaxis treatment, patients will be     arranged to come back to each hemophilia center at least once a year to have investigation of     doses and annual consumption of clotting factors, frequencies and causes of bleedings,     especially joint bleedings, joint outcome by studies of hemophilia joint health score (HJHS),     hemophilia actives list and health-related quality of life. These results will be collected     and compared between intermediate-dose prophylaxis group of patients and on demand treatment     group of patients.      The life span of hemophiliacs has been improved remarkably in recent years due to sufficient     and adequate treatments, especially prophylaxis treatment, therefore comorbidities in the     hemophilic population, e.g. hypertension, diabetes, hyperlipidemia and cancer, etc, have been     found with prevalences close to those in non-hemophilic population. It is worth that the     prevalence of these comorbidity will also be investigated. In addition, basic data of the     patients including age, sex, severity, the development of inhibitor and viral infection etc     will also be collected for analysis.   "
28834|NCT02908230|"     The primary aims of this research project are to:        1. Evaluate the efficacy of Camp NERF to improve child nutrition, physical activity, mental          health, and anthropometric outcomes.        2. Evaluate the efficacy of Camp NERF to improve caregiver self-efficacy for establishing          healthy family nutrition and physical activity practices, amount of physical activity,          and BMI.        3. Evaluate the efficacy of Camp NERF to improve youth mentor nutrition, physical activity,          and anthropometric outcomes.   "
28835|NCT02908217|"     Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical     evaluation is performed using PMR-AS.      The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting     purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale     (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST)     [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).      All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit     until the end of the study, depending on response to treatment and PMR-AS.   "
28850|NCT02908022|"     The overall aim of the present proposal is to investigate how patients' and clinicians'     (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction     correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients     will be recruited for the study.   "
28836|NCT02908204|"     Tumor is the primary public health problem and the incidence of esophageal cancer showed the     increasing trend in the past thirty years. According to the statistics in 2015, the new onset     of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer     in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients     in China. With the development of endoscopic technics, more and more patients choose to     receive the endoscopic procedure rather than traditional surgery. However, the long-term     efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma     received different interventions remained unclear. Thus, investigators aim to conduct a     multi-center retrospective study to investigate the long term outcomes of superficial     esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.   "
28837|NCT02908191|"     This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be     a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the     dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers     are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging     assessment of ABI-H0731 in non-cirrhotic, CHB patients.   "
28838|NCT02908178|"     Patients with ductal carcinoma in situ (DCIS) treated with available therapies have     experienced excellent outcomes and very low mortality rates due to the disease's non-invasive     nature. However, considerable debate exists as to how the DCIS lesion should be treated. As a     result, determining strategies to manage DCIS has been identified as a research priority. The     role of sentinel lymph node biopsy (SLNB) for DCIS management is controversial in general and     needs further scrutiny. Our study addresses this evidence gap as the investigators propose a     retrospective cohort study to investigate the outcome of SLNB among DCIS patients.     Specifically, the investigators will compare the outcomes, including survival outcomes and     treatment side effects, among women older than 67 years of age with DCIS receiving SLNB vs.     not receiving SLNB within 6 months of DCIS diagnosis. The investigators have two primary aims     in this study: Aim 1: the investigators select our study sample using SEER-Medicare database.     The investigators will determine associations between SLNB and acute/subacute side effects,     including lymphedema, pain, and limitation of movement of upper extremity from the first     breast conserving surgery to 9 months post-diagnosis. Aim 2: the investigators will determine     associations between SLNB and long-term outcomes, including breast cancer specific mortality,     ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence,     and lasting side effects, from >9 months post-diagnosis to death or the end of this study     period.      Given the nature of our observational study design, the investigators will apply standard     multivariate analyses and propensity score methodology to reduce the influence from     confounders. The investigators will control for patient demographics, comorbidities,     functional status, tumor characteristics, and prior healthcare utilization. Using distance to     the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage     I/II breast cancer, the investigators also plan to conduct instrument variable analyses if     necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis,     and tumor size) and their predicted life expectancy (given their age and comorbidities), the     investigators also hope to identify patient subgroups who may safely forgo SLNB. The study     would provide evidence on the efficacy and safety outcome of SLNB for DCIS management.   "
28839|NCT02908165|"     The study will be a single-center, randomized Phase II study of conventional TACE in     combination with sorafenib, given either continuously or sequentially, in patients with     unresectable HCC. The primary variables will be tumor response (by MR Imaging) and plasma     VEGF levels, prior to and after cTACE.   "
28840|NCT02908152|"     The purpose of this study is to investigate the effects of curcumin supplement on metabolic     factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes.     Subjects will participate in 3 month, two group, randomized intervention, where one group     (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare     differences in outcomes between the two groups.   "
28841|NCT02908139|"     Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device     in perioperative time after kidney transplantation   "
28842|NCT02908126|"     This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females     undergoing a caesarean section. Two administrations of oxytocin will be tested, after which     uterine contractility will be assessed.   "
28843|NCT02908113|"     We aim to increase our knowledge of the impact of preterm birth on the maturation of the     visual and auditory systems and on the development of multisensory perception      Specifically, we aim to evaluate the preterm infants' capabilities of detection and     discrimination of different visual and auditory stimuli according to gestational age, post     menstrual age and the duration of the postnatal life.      A secondary aim is to compare this competencies in preterm and full term control art term     equivalent age.      The final aim is to optimize the hospital environment in order to make it correspond to the     expectations and sensory abilities of very preterm infants.      Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which     could accelerate the processes of sensory maturation   "
28844|NCT02908100|"     This is a multicenter, Phase II, randomized, double-blind, placebo-controlled,     parallel-group, dose-ranging study to evaluate the safety and efficacy of GDC-0853 in     combination with standard of care therapy in participants with moderate to severe active     systemic lupus erythematosus (SLE).   "
28845|NCT02908087|"     The main objective of the trial is to study whether daily treatment with liraglutide improves     insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide     treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of     type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.   "
28846|NCT02908074|"     This is a 6 months, active treatment, extension study, open to subjects who have completed     full 24 weeks in Study MBGS205 (A Phase IIb multicentre, double-blind, dose-ranging,     randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese     subjects with hypogonadotropic hypogonadism [HH]).The main purpose of Study MBGS206 is to     evaluate bone mineral density and other long term safety and efficacy parameters in subjects     after 12 months exposure with BGS649.   "
28847|NCT02908061|"     The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along     with the usual bladder removal surgery, versus having the usual bladder removal surgery     without the use of the mesh.   "
28848|NCT02908048|"     The study will examine and evaluate the use of extracellular RNA in blood as markers for the     diagnosis of liver disease or cancer, and as markers for prediction of response to treatment     or recurrence of cancer after surgery   "
28849|NCT02908035|"     This is a prospective, multi-center, randomized, dose escalation study to document the     effects of adventitial delivery of temsirolimus (Torisel) after revascularization of lesions     below the knee in symptomatic patients with critical limb ischemia (CLI).   "
28853|NCT02907983|"     Hot flashes and night sweats (i.e., vasomotor symptoms, VMS) affect 80% of women during the     menopausal transition (MT). VMS are associated with decreased quality of life, increased     depressive and anxiety symptoms, memory complaints, sleep disturbance, and reduced work     productivity. Hormone therapy (HT) is highly effective in reducing VMS, but the use of HT     declined 75% to 80% in the U.S. after the Women's Health Initiative (WHI) raised safety     concerns about HT. In 2013, the Food and Drug Administration (FDA) approved paroxetine, a     selective serotonin reuptake inhibitor (SSRI; 7.5 mg), as the first non-hormonal treatment     for VMS. SSRIs are an important treatment option for many women, but their use in treating     VMS is limited by lower effectiveness when compared to HT, side effects, and relapse of     symptoms following treatment discontinuation. Identifying safe and effective non-hormonal     treatments for VMS remains a priority in women's health research.      Stellate ganglion blockade (SGB), used for decades in pain management, is a potential new     approach to VMS treatment. Located in the cervical spine region, the stellate ganglia are     part of the sympathetic nervous system. Although SGB is commonly performed to treat     neuropathic pain, hyperhidrosis or vascular insufficiency, anatomic studies reveal     connections between this ganglion and thermoregulatory regions of the brain, specifically the     insular cortex.      In this clinical trial, we aim to assess whether stellate ganglion block (SGB) with     bupivacaine, a local anesthetic, is an effective and safe non-hormonal intervention for women     seeking relief from vasomotor symptoms (VMS), and identify the physiologic mechanisms     underlying SGB effects. Outcomes will include frequency and intensity of hot flashes,     objectively-measured VMS, mood, quality of life, sleep, and memory performance in 220     postmenopausal women with 28 or more moderate to very severe hot flashes per week as measured     by self-report for six months. They will be reassessed at 3 and 6 months following the SGB or     a sham intervention for objective hot flashes and quality of life measures. Mechanistic     outcomes (neuroimaging) will be obtained at baseline and 3 months following the intervention.     Ambulatory monitoring of sympathetic nervous system function (SKNA) will be performed at     baseline before the procedure, during the procedure and 1 hour following the procedure. This     will be repeated at 2 and four weeks following the SGB or sham procedure for 1 hour     recordings.   "
28854|NCT02907970|"     FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island     and key levers for improvment.   "
28855|NCT02907957|"     Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients     following urological and lower extremity procedures. The injection of local anesthetic into     the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a     vasodilation, or increased blood flow, to the lower extremities.      The purpose of this study is to determine whether the FLIR ONE thermographic camera, a     smartphone attachment which utilizes an application (app) to measure the temperature at a     site on an image of the lower extremity, will be able to differentiate between caudal,     non-caudal, and failed caudal images.   "
28856|NCT02907944|"     Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What     if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use     disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics?     Implementation Facilitation is an established strategy to increase the uptake of     evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation     on the use of addiction treatments in four large HIV clinics.      The purpose of the WHAT-IF study is:      Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to     identify the site-specific evidence, context and facilitation-related barriers and     facilitators to the integration of addiction treatments to help tailor an Implementation     Facilitation for each clinic.      Aim 2. To evaluate the impact of Implementation Facilitation on:      2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to     deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in     organizational models of care used to deliver addiction treatments      Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy     receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible     for addiction treatment.   "
28876|NCT02907684|"     The purpose of this study is to investigate the cardio-metabolic health effects of consuming     almond nuts in place of habitual (usual) snack products in adults at moderate risk of     developing cardiovascular disease   "
28877|NCT02907671|"     Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome     treatment comparing two different injection sites. Single-blind randomized trial.   "
28857|NCT02907931|"     Ultrasound represents an attractive non-invasive method to assess hemodynamic status.     Understanding dynamic changes in hemodynamics in situations such as hypovolemia, sepsis, and     cardiogenic shock can potentially help improve patient care. However, the inter-rater     reliability and accuracy of how various ultrasound measurements reflect dynamic changes in     physiology remains incompletely understood. Overall our aims are to investigate the use of     ultrasound in a controlled setting, specifically using lower body negative pressure (LBNP),     which can simulate hypovolemia at varied levels in human volunteers.      Aim 1: To determine the change in carotid blood flow (measured by velocity time integral,     VTI) in subjects undergoing simulated hypovolemia at LBNP levels that precede vital sign     changes.      Hypothesis: Carotid VTI will demonstrate significant changes that precede vital sign changes     in simulated hypovolemia.      Aim 2: To compare transcranial color Doppler indices of cerebral blood flow with carotid     blood flow, as assessed by VTI of the common carotid artery.      Hypothesis: Changes in transcranial color Doppler indices of cerebral blood flow will be     mirrored by changes in carotid blood flow, indicating carotid VTI is an adequate surrogate     for measuring cerebral blood flow in variable states of central hypovolemia. However, if     cerebral blood flow remains more constant than carotid blood flow throughout varying levels     of hypovolemia, our assumption is that cerebral autoregulation alters the relationship     between carotid and cerebral blood flow. The more complex procedure of Transcranial Doppler     ultrasound (TCD) must be performed to obtain valid assessments of cerebral blood flow.   "
28858|NCT02907918|"     The investigators propose to influence estrogen receptor (ER) signaling by combining     endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal     growth factor receptor 2 (HER2)+ early stage breast cancer.   "
28859|NCT02907905|"     Social insecurity is a significant cost in human terms (health and societal), it defines evil     and can be identified as difficulties accessing health and especially water.      We chose to take stock of these populations defined by difficulties accessing water as     precarious setting. Subjects homeless population fall into this by accident of life, a life     homeless or migrant subjects often illegally having only transitory access (associative or     charitable structures host) the conditions precarious sanitation including drinking water or     toilet. Populations of slums in the same conditions or the presence rationed water (one tap     for 150 people) restricts hygiene.   "
28860|NCT02907892|"     A randomized controlled trial to determine whether changing of gloves by the surgical team     during cesarean section may decrease post-operative infectious morbidity and wound     complications   "
28861|NCT02907879|"     The objective of the study is to assess brain tissue perfusion by ultrasound perfusion     imaging. Specifically        -  to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to          assess specificity and sensitivity, and predictive values for detection of brain tissue          hypoperfusion leading to infarction        -  to test whether treatment-effects by induced hypertension, balloon-dilatation, or          intra-arterial nimodipine infusion can be detected and quantified by UPI   "
28862|NCT02907866|"     Endobronchial ultrasound (EBUS) is a technique that uses ultrasound along with bronchoscope     to visualize airway wall and structures adjacent to it. Pneumothorax is a known complication     from EBUS procedure. To rule out a Pneumothorax after the procedure, a Chest -X-ray is     usually done. Point-of-care sonography has emerged as an invaluable tool in the assessment of     patients with both traumatic and non-traumatic dyspnea. Multiple studies involving bedside     ultrasound has shown that a pneumothorax can easily be ruled out if pleural sliding sign or B     lines are visualized on lung ultrasonography; the accuracy of lung ultrasound in ruling out     pneumothorax approach computed tomography and exceed plain radiography. Preforming a lung     ultrasound using the EBUS bronchoscope tip as a way to rule out pneumothorax has never been     described previously. If this is possible it will obviate the need of getting a Chest -X-ray     and decrease the dose of radiation that the patient is exposed to. In this study we will     demonstrate that the feasibility of using the transducer of the EBUS Bronchoscope to perform     bedside lung ultrasound to rule out pneumothorax.   "
28863|NCT02907853|"     This study will link findings from neuroscience with clinical outcomes using contingency     management (CM) to identify changes in brain structure and function that emerge during purely     behavioral therapy for methamphetamine (MA) use.   "
28864|NCT02907840|"     The study will explore the possibility to predict potential for recruitment in acute     hypoxemic respiratory failure patients by electrical impedance tomography (EIT) Swisstom BB2     (Swisstom, Landquart, Switzerland) during stepwise increase in positive end-expiratory     pressure (PEEP) followed by recruitment maneuver (RM). It will compare data obtained by EIT     to those obtained by pressure-volume (P-V) curves on respiratory system mechanics and data on     pulmonary gas exchange.   "
28865|NCT02907827|"     Patients with locally advanced melanoma are at high risk for recurrence following surgical     treatment. More patients with stage IV melanoma remain in complete remission following     systemic therapy. No standards have been established for the surveillance of patients at high     risk for recurrence. Whole-body diffusion-weighted magnetic resonance imaging and cfDNA     analysis of blood are innovative imaging and laboratory investigations that may be of benefit     for early detection of recurrence in this patient population.   "
28866|NCT02907814|"     Optical Coherence Tomography (OCT) is routinely used in ophthalmic clinical practice. It uses     infrared light to image patient's eyes. Some patients, such as those with an inflammatory     disease called uveitis or those who have just undergone cataract surgery, have intraocular     inflammation. This intraocular inflammation commonly manifests as cells that can be seen on     routine microscopic clinical examination. However, the only currently available method to     quantify this intraocular inflammation is by manually counting on the microscopic clinical     examination. The investigators plan to use the OCT machine to image patient's eyes. The     investigators will then use the images obtained from the OCT to objectively quantify the     degree of intraocular inflammation.   "
28887|NCT02907541|"     This study evaluates the use of eLearning of quality improvement methods. Participants who     use eLearning only, facilitated learning only and a combination of eLearning and facilitated     learning will complete questionnaires and be interviewed to establish the effect of eLearning     of quality improvement methods to improve knowledge, change in behaviour and impact on     healthcare services for better patient care.   "
28867|NCT02907801|"     Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry     that interferes with their development. The use of the Perception-Action Approach (P-AA)     intervention in infants with CMT is supported by a single case report and needs to be     researched further to determine its efficacy. This study will investigate the immediate     effects of the P-AA intervention on habitual head deviation from midline, active head     rotation range of motion, and functional use of both sides of the body in infants with CMT.      The participants will be 3 infants with CMT, aged birth to 9 months. A randomized,     nonconcurrent A-B multiple baseline design across subjects will be used. The intervention     phase will include 5 daily PT sessions, with outcome data collected at the end of each     session.      It is hypothesized that improvements on all outcome measures will be documented upon the     initiation of the P-A Approach intervention, with the most substantial change expected in     habitual head deviation from midline measured by still photography.   "
28868|NCT02907788|"     Airway disease, featuring intense inflammation, is the main cause of morbidity and mortality     in cystic fibrosis (CF). Mechanisms of CF airway inflammation remain unclear, hampering     development of better treatments.This time-sensitive ancillary study leverages a unique     longitudinal cohort of CF infants, assessing the early phase of airway disease. Through the     use of innovative cell and fluid based tools for in vivo profiling and in vitro testing of     BALF samples, this translational effort will yield unprecedented insights into mechanisms of     PMN dysfunction in CF, and assess new paths for early intervention.   "
28869|NCT02907775|"     Over 87,000 people have a first stroke in the UK each year; about 70% of victims have altered     arm function and about 40% are left with a non-functional arm. Spasticity is a significant     deterrent for recovery of arm function following stroke. One in four patients develop     spasticity within the first 2 weeks of the stroke and by 12 months 39 % have spasticity. The     use of oral antispasticity medications like baclofen and tizanidine are often restricted due     to side effects like sedation, weakness and floppiness. Compliance of adults to treatment     with oral anti spasticity drugs is only around 50%.      There are a few exploratory studies on sensory stimulation using Transcutaneous Electrical     Nerve Stimulation (TENS) in reducing spasticity. Amatya et al reviewed the evidence and     concluded that there was not sufficient evidence to recommend its routine use. One possible     explanation for the ineffectiveness of TENS is that it uses a single channel, single strength     and fixed duration stimulation to which the nervous system may get habituated. We have     developed Shefstim; a unique miniaturised 64 channel electrical stimulator. Using Shefstim we     pioneered a technique called Sensory Barrage Stimulation ;rapid simultaneous stimulation at     multiple sites, in a constantly changing pattern. We hypothesise that this approach will     significantly reduce habituation compared to single site stimulation, thus providing a better     treatment for spasticity.      Objective of the proposed study is to to explore the feasibility of conducting a community     based randomised cross over trial comparing SBS with TENS for post stroke upper limb the     spasticity of elbow flexors to optimise the stimulation parameters through quantifying     objectively the muscular response to two different stimulation protocols.   "
28870|NCT02907762|"     The First In Human (FIH) study is a long-term, single center, non-randomized study     established by Lombard Medical, Inc. to collect on-label data in the clinical setting on     patients undergoing endovascular repair with IntelliFlex™, the latest generation of the     Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and     aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an     angle between 0° and 90°.   "
28871|NCT02907749|"     The aim of this study is to investigate the effects of spironolactone on liver fibrosis     progression and portal hypertension in patients with compensated cirrhosis. The patients were     nonrandomized according to the medical conditions determined by the physicians, in 3 arms     (spironolactone start from 40mg once daily and increase every week with a maximum dose as     100mg once daily, carvedilol start from 6.25mg once daily and increase to 12.5mg once daily     in next week if being tolerated, spironolactone in combination with carvedilol:     spironolactone is added when carvedilol has reached the most tolerated dose). Portal pressure     gradient by virtual hepatic venous pressure gradients based on enhanced CT, and liver     elasticity by Fibroscan Medical Device are documented at baseline level and every six months     after the treatment. Changes in serum fibrosis markers and liver function are monitored     before and every 3 months after the treatment.   "
28872|NCT02907736|"     Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment     and mortality worldwide despite the development of revascularization therapies (intravenous     Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV     t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years,     neutrophil extracellular traps (NETs) have been identified as major triggers and structural     factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA     from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively     correlated with the infarct size and negatively correlated with electrocardiogram     (ST-segment) resolution. This later study revealed that in vitro addition of DNase I     accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be     promising targets for improved thrombolysis in AIS.      The aim of this study is to assess the impact of NETs composition of thrombi retrieved during     endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and     AIS etiologies.   "
28874|NCT02907710|"     A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal     carcinoma were enrolled. Patients were randomly divided into two groups, with 150 patients in     each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar     and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy     and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year     overall survival and progression-free survival of patients were analyzed. The investigators     data may provide an alternative option for the treatment of Locoregionally advanced     nasopharyngeal carcinoma with high efficacy and low toxicity.   "
29005|NCT02905994|"     The study intervention involved in this study is the addition of a dose of volasertib as a     part of the initial chemotherapy regimen for AML.      The trial will involve a combination of the following drugs:        -  Volasertib (the study drug)        -  Idarubicin        -  Cytarabine   "
28878|NCT02907658|"     Background. The reduction of prevalence rates of Internet Use Disorder (IUD) and its     effective treatment are at high priority in both public health and educational policies.     School-based preventive interventions facilitate a low-threshold approach for individuals     with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated     approaches which target adolescents at high-risk show larger effects than universal     prevention approaches. Simultaneously, they reduce unnecessary burden for the majority of     high-school students that is not at-risk. The PROTECT intervention for indicated prevention     of IUD in school settings was developed based on these preventive strategies.      Methods. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in     Germany, screened for high-risk of IUD onset, will be randomly assigned to a) PROTECT     intervention group or b) assessment only control group. The tested intervention consists of a     cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12     months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary     outcomes are the reduction of IUD and comorbid symptoms and the promotion of problem solving,     cognitive restructuring and emotion regulation skills.      Discussion. The indicated preventive intervention PROTECT follows the APA-guidelines for     psychological prevention. It is theory- and evidence-based (guideline 1) and addresses both     risk-reduction and strength-promotion (guideline 3), it considers current research and     epidemiology (guideline 4) and ethical standards (guideline 5) such as professional secrecy     and is designed as a systemic intervention (guideline 8) at the school-level. It is expected     that the intervention decreases risk of IUD onset (incidence rate).   "
28879|NCT02907645|"     Influenza vaccine is recommended as routine care for all individuals who are at least 6     months of age and older. Recently, questions about vaccine safety and concerns for side     effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an     effort to educate patients, public health entities and physicians give informational handouts     in various forms.      However, recent publications have found that pro-vaccine messages can have paradoxical     effects on vaccine intentions, therefore further studies on vaccine related public health     communication is needed. The purpose of this study is to compare the effectiveness of     pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational     message on patient's receipt of the influenza vaccine. These results will help to understand     the relationship between patient education and the intent to vaccinate and receipt of the     influenza vaccine as well as to optimize educational information given to patients regarding     the influenza vaccine.   "
28975|NCT02906384|"     This is a prospective, randomized phase-II study observing the memory preservation and     functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell     compartment during prophylactic cranial irradiation for small cell lung cancer patients.   "
28880|NCT02907632|"     Gastroesophageal Reflux (GER) is a condition that affects the majority of premature infants     that are followed at the Kangaroo Mother Care Program (ambulatory program for preterm infants     discharged with their mothers in continuous skin to skin contact and strict outpatient follow     up). For over 20 years, the use of Metoclopramide has been systematic among all preterm     infants according to the protocols of the Kangaroo Mother Care (KMC) Program . The aim of     this clinical trial is to evaluate the effectiveness and security of metoclopramide to lessen     the symptoms of GRE in premature infants that are followed and treated in the Ambulatory KMC     Program before 40 weeks of gestational age. Design: Randomized, double blind trial,     controlled with placebo. Eligible Population: Premature infants that are followed and treated     in the Ambulatory Kangaroo Mother Care Program at Hospital Universitario San Ignacio before     40 weeks of gestational age, which systematically receive: metoclopramide 0.2 mg per kg,     every 8 hours, 15 minutes before every feeding up to 40 weeks of gestational age, between     January 01 2017 and December 31 2017.Outcomes: Incidence of regurgitation episodes reported     by the parents of the infants, episodes of apnea, bronchoaspiration, postprandial     irritability, the infant rejects feeding, alteration in the postprandial posture and the     frequency and severity of adverse effects associated with the use of Metoclopramide such as     extrapyramidal symptoms and sedation. In the case of continuous variables, the mean and     median will be compared according to the distribution and for nominal variables, a chi     squared test or fisher test will be carried out.      Duration: 12 months. Ethical Aspects: Experiment with minimum mayor risk. Informed consent     will be requested to parents. An independent committee from the work group will be in charge     of carrying out the follow-up of the safety and progression of the study. A methodological     expert, a thematic expert, a statistician and an expert in bioethics will constitute the     committee.      Financial Disclosure: The study will be funded through the Kangaroo Foundation with the     collaboration of the  Hospital Universitario San Ignacio, Bogotá, Colombia.   "
28882|NCT02907606|"     This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and     dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and     detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.   "
28883|NCT02907593|"     This is a phase I/II open-label study to determine the lowest, safe, effective dose of     budesonide given with calfactant as the vehicle.   "
28884|NCT02907580|"     Influenza vaccine is recommended as routine care for all individuals who are at least 6     months of age and older. Recently, questions about vaccine safety and concerns for side     effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an     effort to educate parents and patients, public health entities and physicians give     informational handouts in various forms. However, recent publications have found that     pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further     studies on vaccine related public health communication is needed. Few, if any, studies have     analyzed the relationship between influenza vaccine attitudes and intention with actual     vaccine receipt in the pediatric population. These results will help to understand the     relationship between parent's vaccine perception and the intent to vaccinate versus the     child's receipt of the influenza vaccine, as well as to optimize educational information     given to families regarding the influenza vaccine.   "
28885|NCT02907567|"     This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study of     two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the     safety and tolerability of oral CT1812, administered for 28 days. This trial may include up     to 8 qualified investigator sites in Australia.   "
28886|NCT02907554|"     Organ donors included in the study are randomized to a control group or an intervention group     receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these     patients are transplanted to chronic kidney insufficiency patients. According to the     pretreatment of the transplant, delayed graft function during the first week was evaluated as     well as kidney function at different timepoints and mortality during the first year after     transplantation.   "
29006|NCT02905981|"     The main purpose is to determine whether Triferic, administered orally with Shohl's solution,     is safe and effective for the treatment of iron-refractory iron-deficiency anemia (IRIDA).   "
28888|NCT02907528|"     Objective: To clinically evaluate mandibular furcation treated with Beta tricalcium     phosphate/hydroxyapatite (βTCP/HA) isolated or combined with enamel matrix derivative (EMD +     βTCP/HA) and EMD alone.      Material and Methods: 39 patients, presenting at least one mandibular class II furcation     defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, were included. The defects     were assigned to the βTCP/HA group 1 (n = 13); open-flap debridement (OFD) + βTCP/HA filling;     βTCP/HA + EMD group 2 (n = 13); OFD + βTCP/HA + EMD filling; and EMD group 3 (n = 13) OFD +     EMD filling. Plaque (PI) and gingival index (GI), PPD, relative gingival margin position     (RGMP), vertical and horizontal attachment level (RVCAL and RHCAL), and furcation diagnosis     were evaluated at baseline, 6 and 12 months.   "
28889|NCT02907515|"     The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2     IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant     overdentures are proven to be a successful treatment option for older edentulous adults but     we need to know if the CM-LOC attachment will retain its superiority over the ball     attachments intraorally regarding the prosthetic complications in single implant retained     overdenture like in 2 IOD   "
28890|NCT02907502|"     To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two     iso-energetic, young-child formulas with different protein content during the second year of     life   "
28891|NCT02907489|"     The purpose of this study is to determine whether the use of triple antibiotic paste as     intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will     reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic     necrotic teeth.   "
29696|NCT02896972|"     To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap     technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to     demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using     swept-source optical coherence tomography (OCT)   "
28892|NCT02907476|"     This randomized controlled trial is designed to test the Vagal-gamma amino-butyric acid     (GABA) Hypothesis that one of the mechanisms by which yoga-based practices improve mood and     decrease anxiety is by correcting an autonomic system (ANS) imbalance with too much activity     in the sympathetic nervous system (SNS) and too little activity in the parasympathetic     nervous system (PNS). This imbalance is associated with under activity in the GABA system. It     is hypothesized that yoga-based practices increase activity in the PNS by increasing     respiratory sinus arrhythmia (RSA), which is associated with increased activity in the GABA     system and decreased depressive and anxiety symptoms.   "
28893|NCT02907463|"     The purpose of this active, observational, open-label, non-randomized, post-market     surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in     MIS setting when compared to published data with a conventional valve within the MIS setting.     The published dataset will used as a control group. Then to describe short term (30 days) and     long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS     INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess     Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at     baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital     discharge.   "
28894|NCT02907450|"     The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate     mandibular growth or in interception / contention.      The proposed research project will focus initially on assessing the comfort and safety of     TwiCare® device. The orthopedic efficiency therefore not part of this study.      The comfort and safety of the brace will be evaluated firstly by the practitioner during the     visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and     with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after     the start of the port of the device, and during the control visit at 11 weeks.   "
28895|NCT02907437|"     Current medications have only a limited effect on two core symptoms of schizophrenia,     negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline     which has a beneficial effect in various neurological disorders. In the past years, various     findings from clinical studies showed its potential role for the treatment of these symptoms     of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on     treatment for alleviating positive, negative and cognitive symptoms in schizophrenia     patients.The current study is a single center, double-blind, randomized study that assess the     adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic medications, in     adult patients suffering from schizophrenia. Patients will be recruited and randomly     allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of treatment. In     addition, all patients will receive probiotics (450mg/day) in order to prevent any     gastrointestinal influences of antibiotics administration. Positive and negative symptoms ,     as well as cognitive functions will be assessed before and after treatment.   "
28896|NCT02907424|"     In order to make Cambodia independent from importing a product for the treatment and     prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a     collaboration for the development of a range of products for the treatment and prevention of     malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances,     the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The     main objective of this sub-study is to test the efficacy of the newly developed RUTF on the     recovery of children suffering from severe acute malnutrition. As comparison, the current     treatment of SAM with BP-100 will be used.   "
28897|NCT02907411|"     Quad Rivas Therapy has been developed by Alyna Eekma from the Netherlands for over thirteen     years; anecdotally she has been able to significantly reduce lipedema SAT in women with Stage     1 and 2 lipedema, and can reduce lipedema SAT by 80% in women with Stage 3 lipedema. The     study will last for one month, for a total of 12 treatments per subject, seven subjects     total, to see if there is a change in percent body fat percentage over the course of these     treatments.   "
28898|NCT02907398|"     Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in     the clinical practice setting; 2) collect additional information on the effectiveness, use     and safety in the commercial setting; and 3) engage physician customers to report the     collective outcome within a group of properly trained programs that utilize Inspire therapy     on a regular basis.   "
28899|NCT02907385|"     LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over     the anastomotic line to prevent bowel content leakage until full physiological function is     restored.      RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared     complications in colorectal surgery. The risk of postoperative anastomotic leakage varies     widely depending on the level of anastomosis while the risk is higher in low anastomosis.      In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement     and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal     and coloanal anastomoses performed within 10 cm from the anal verge.      STUDY DESIGN: This study is designed as a prospective, multi-center, multinational     randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this     study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in     overall anastomotic leak rates in subjects undergoing low anterior resection with an     anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.      SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of     post-operative leaks and additional benefits that could be related to the use of LifeSeal™     Kit such as reducing the severity and improving the outcome of a leak once it has occurred.     In addition, the study will allow for collection and analysis of additional safety data and     usability assessment of the device, medical resource utilization, and health related quality     of life measures.   "
28900|NCT02907372|"     This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or     enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the     influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate     the quality of life and the adherence of patients who had or develop cognitive disorders.   "
29821|NCT02895334|"     This study will conduct an initial clinical evaluation of this support program to examine its     impact on reducing caregiver stress, increasing confidence in daily feeding, and improving     weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).   "
28901|NCT02907359|"     A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the     efficacy and safety of guadecitabine in subjects with MDS or CMML who failed or relapsed     after adequate prior treatment with azacitidine, decitabine, or both. This global study will     be conducted in approximately 15 countries. Approximately 408 subjects from approximately 100     study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately     272 subjects) or Treatment Choice (approximately 136 subjects). The study consists of a     14-day screening period, a treatment period, a safety follow-up visit, and a long-term     follow-up period. The study is expected to last more than 2 years, and the duration of     individual subject participation will vary. Subjects may continue to receive treatment for as     long as they continue to benefit.   "
28902|NCT02907346|"     The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic     intervention to increase use of continuous glucose monitors (CGM) in adolescents and young     adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her     research team at University of Connecticut School of Medicine (UConn Health). The     intervention will reinforce patients for wearing CGM and for uploading it and reviewing its     data. A 6-month pilot trial will be conducted with up to 20 patients receiving the     intervention. The specific aims are:   "
28903|NCT02907333|"     Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 3-6 months     after the diagnosis with new examinations. The regression rate is based solely on the woman's     own ability to clear the cervical lesions. The use of condoms has shown a relatively good     protective effect against Human Papillomavirus (HPV) infection. It has furthermore been     indicated that condoms increase the regression rate of cervical lesions.      The hypothesis of this study is that the regression rate of cervical intraepithelial     neoplasia grade 2 (CIN2) increases when condoms are used consistently in the follow-up period     of 3-6 months.   "
28904|NCT02907320|"     Chronic Venous Disorder is the most prevalent vascular disease. It is multifactorial     pathology that has an important impact on quality of life and represents a significant public     health concern, due to its very high frequency in all European and American (north and south)     countries.      Venous pathology develops when venous pressure is increased and return of blood is impaired     through several mechanisms. Wish induce leg symptoms (tingling, aching, burning, pain, muscle     cramps, sensation of swelling, sensations of throbbing or heaviness, itching skin, restless     legs, leg tiredness and/or fatigue.      The aims of this research is to study the effects on microcirculatory activity (activity on     very small vessels) of CYCLO 3 ® FORT, MPFF (Micronised Purified Flavonoid Fraction) and     Placebo after 8 week of treatment by Microscan, and Duplex, two imaging non-invasive     technologies will be performed to obtain measurements of microcirculatory parameters in     standardized and reproducible conditions for all the participants. In addition, will assess,     in blood samples, the inflammatory biomarkers .   "
28905|NCT02907307|"     The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and     LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal     tablet in woman with vulvovaginal candidiasis (VVC)   "
28906|NCT02907294|"     To assess the safety and tolerability of five doses of PBF-999 (160 mg and 320mg) after     repeated (8 days) single daily oral dose administration in young male and female healthy     subjects.   "
28907|NCT02907281|"     This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome     measure in patients with relapsing remitting multiple sclerosis (RRMS).      Approximately 350 RRMS patients, either untreated or treated with an approved MS     disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or     neurologic disease are enrolled. No study medications are provided. Patients on     disease-modifying therapy are treated according to the local prescribing information. For     each MS patient and each reference subject, the study consists of Screening (up to 1 month),     Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed     during Screening.   "
29007|NCT02905968|"     The purpose of this study is to evaluate the effectiveness of transanual tube placement in     low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.   "
30248|NCT02889783|"     This is a routine evaluation of urethral sensation during urodynamic studies. The record has     been realized retrospectively. The investigators propose a new way to represent urethral     sensation, in a simple and non-invasive way.   "
28908|NCT02907268|"     A 16-week single-blind, split-face, randomized study. Each patient served as their own     control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or     right side of the face. Patients received intradermal BTXA injections at week 0 and     intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of     intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface     lift while reducing pore size and sebum production, as well as investigate the differences in     effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and     intramuscular injection methods.   "
28909|NCT02907255|"     Patients are at risk of respiratory depression after having surgery. The medications that     patients are treated with to control their pain can impair their breathing and this can     progress to respiratory and cardiac arrest and even death. Vital signs assessment on surgical     wards is usually done every 4 hours and this may be insufficient to identify and manage many     cases of respiratory depression. The aim of this study is to determine the impact on safety     and nursing workflow of a respiratory monitoring on two surgical wards by measuring safety     outcomes. Respiratory depression is a serious complication of pain treatment that can lead to     patient complications and death. The level of monitoring available in hospitals by nursing     staff is insufficient to manage this problem. If this new monitoring technology works as     designed then patient safety can be improved while maintaining effective pain therapy.   "
28910|NCT02907242|"     The purpose of this study is to evaluate the role of an integrated strategy at selecting     fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental     ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.   "
28911|NCT02907229|"     This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1,     a newly developed honeycomb microporous covered stent, for the treatment of intracranial     aneurysms which are difficult to be cured by conventional surgical or endovascular     procedures.   "
28976|NCT02906371|"     This is a two cohort, open-label, pilot study to describe the efficacy of administration     timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events     in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic     leukemia with high versus low pre-infusion tumor burden following redirected autologous T     cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).   "
28912|NCT02907216|"     The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria,     tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with     or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants     aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since     2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been     evaluated during the clinical development of the HRV vaccine, the vaccine differed in     composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in     Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study     will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when     co-administered with the liquid HRV vaccine   "
28913|NCT02907190|"     The objective of this study is to compare the glycemic and insulinemic response elicited by ½     cup servings of 6 beans to those elicited by ½ cup servings of mashed potato, macaroni, rice     and corn.   "
28914|NCT02907177|"     This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod     vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).   "
28915|NCT02907164|"     The investigators are interested in using social norms to motivate people to sign up for a     100-day exercise challenge and exploring how to make social norms messages more effective.   "
28916|NCT02907151|"     To assess the value of a dedicated knowledge questionnaire, filled by the patient prior     consultation. Indeed, it could allow to target specific shortcomings of patients first, and     help the cardiologist to prioritize the other therapeutic education, targeting specifically     the information provided.   "
28917|NCT02907138|"     The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to     conventional treatment provided by a physical therapist, for people with perceived     stress-related symptoms.      Forty people are to be randomized to either:        1. Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week,          with the guidance of a physical therapist.           or        2. Control - treatment as usual (TAU) in physical therapy.   "
28918|NCT02907125|"     SEHER Plus- Strengthening Evidence base on scHool-based intErventions for pRomoting     adolescent health, seeks to evaluate a school based adolescent health promotion intervention     delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school     counsellor called as SEHER Mitra (SM) in government- run secondary schools in Bihar, India.     SEHER Plus will be implemented in the same randomly assigned 74 schools wherein, the SEHER     trial (ClinicalTrials.gov ID: NCT02484014)-a three armed clustered randomised trial (CRT) was     implemented to evaluate the effectiveness and cost-effectiveness of these two models compared     with the Tarang-Adolescence Education Programme (usual care) implemented by the State     Government of Bihar.      The SEHER trial hypothesised that both interventions, compared to the control arm, would lead     to a greater impact on school climate (school connectedness and relationship with teachers     and fellow students). In addition, the interventions would increase the knowledge, attitude     and awareness, and promoting healthy behaviours in youth on reproductive and sexual health     outcomes, mental health and substance use, and gender related attitudes and violence. The     SEHER trial also hypothesized that the addition of more resource intensive component (the SM     arm) would be associated with the best outcomes. The hypothesis for the SEHER Plus is that     students who will have exposure to the SEHER intervention activities in two academic years     (Class IX and X) will show greater benefits on the primary, secondary and exploratory     outcomes than students who have exposure to the SEHER intervention activities in one academic     year (Class IX).   "
28945|NCT02906774|"     This is a proof-of-principle research study designed to determine whether fecal microbiota     transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract     of renal transplant patients. The primary goal of this study is to test whether oral gut     decontamination followed by FMT by enema delivery will result in decolonization of the     intestinal tract of renal transplant patients shortly after solid organ transplantation,     thereby preventing difficult to treat post-transplant infections.   "
28919|NCT02907112|"     Excessive meat consumption, particularly of red and processed meat, is associated with     increased risk of developing a range of chronic diseases. Meat production also significantly     contributes to the production of global greenhouse gasses (GHG). Given the predicted global     increase in the human population, coupled with the rise in demand for meat within emerging     economies, it has been suggested that strategies to alter dietary patterns and reduce meat     intake should be devised. With the provision of appropriate non- or reduced-meat     alternatives, this study aims to investigate whether free living subjects can significantly     reduce their meat intake, and whether such dietary changes positively impact on a range of     health measures   "
28920|NCT02907099|"     The goal of this clinical research study is to learn about the effectiveness, safety, and     tolerability of pembrolizumab in combination with BL-8040 when given to patients with     advanced pancreatic cancer.   "
28921|NCT02907086|"     Observational study to allow the collection of blood and medical information to evaluate the     role of circulating tumor material in patients with colorectal cancer and melanoma   "
28922|NCT02907073|"     The goal of this proposal is to perform first-in-man evaluation of and experimental imaging     agent F-18 tetrafluoroborate (BF4) or (TFB).   "
28923|NCT02907060|"     A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies     (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th     degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of     oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all     pregnancies are prolonged.      A Cochrane review on induction of labour showed that a policy of labour induction at or     beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French     College of Obstetricians and Gynaecologists stated, induction of labour can be proposed to     patients between 41+0 and 41+6 weeks of gestation. In cases where labour is induced and     cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include     pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double     balloon) methods. Those two methods were compared in the PROBAAT trial among women with term     pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were     identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical     ripening was mechanical.      Considering pharmacological cervical ripening is associated with more uterine hyper     stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile     foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are     associated with a risk of FHR anomalies and that cervical ripening with a pharmacological     method is another factor which increases this risk: women with prolonged pregnancies could     benefit from a more gentle cervical ripening.      At present, no particular method is recommended in cases of cervical ripening and prolonged     pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical     ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more     appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.   "
28924|NCT02907047|"     The purpose of this study is to correlate functional outcomes and perioperative complications     with tourniquet use during total knee arthroplasty.   "
28925|NCT02907034|"     Financials constraints of health systems require suitable indices and criteria to better     allocate resources in order to enhance and maximize social welfare. Among multiple methods,     the quality-adjusted life year (QALY) is used as a validated and preference-base measure for     health care procedures in health economics studies such as cost-utility analyses.      In France, the methodological guide of the public agency of the High Authority for Health     (HAS) recommends the valuation of health states with the use of a generic and descriptive     instrument (EQ5D), validated by the Time Trade Off method (TTO) in samples from general     French population.      Although it appears to be legitimate to distribute collective resources based on general     population preferences, a major concern is that individuals do not face a real choice that     can have a direct implication on their welfare and their life.      The existence of a discrepancy between revealed hypothetical preferences and real     preferences would raise the problem concerning production of the currently available     standards and norms. Hence, a methodological deepening of these preferences revelation     process is necessary.      Virtual reality (VR) could play a key role in resolving this methodological problem. Widely     used in the field of health (such as therapy, medical training...), VR is a simulation that     seeks to approach the reality, without trying to be quite like it. It aims one or more     individuals to explore a sensorimotor and cognitive activity in an artificial world in 3D,     which can be imaginary, symbolic or a simulation of some aspects of the real world (Fuchs,     2006). VR could be well applied to the field of health economics by offering hypothetical     scenarios of the different health states from the EQ5D that individuals might experience in     the first person.      To date, existence of this discrepancy between revealed hypothetical preferences and actual     preferences of individuals from the general population is extremely difficult to explore.     However, this is an important methodological challenge in the revelation of preferences to     guide health-related decisions.      Indeed, comparing the revealed preferences about health states established from a first     person experience in VR to the revealed preferences established from the classic narrative     approach without VR, may provide an accurate approach of actual and real preferences of     individuals from the general population.      Moreover, another advantage of VR is to permit the assessment of a greater number of health     states, this method being faster processed than the narrative approach: individuals are     experimenting immediate experience of a situation when under VR. Thus, VR method may overcome     technical constraints of the classic narrative approach concerning limited sample sizes in     norms production.      To the investigators knowledge, VR has never been proposed for valuating health conditions.      This study would report the relevance and interest in using VR (immersive and immediate life     situation experience) for the production of utility EQ5D health states values in the general     population by the revelation of preferences method called the Time Trade Off (TTO), the     currently approach recommended by the HAS.      Using VR could circumvent some limitations of the current narrative approach: it would     provide a better feasibility and acceptability among subjects, fewer inconsistencies, an     easier and wider access to disadvantaged individuals. Eventually revisions of available     standards could be proposed to allow the HAS and policy makers to base their choices on more     reliable, standardized and accurate classifications of health states conditions, that     associate each health state to a predefined value.   "
28977|NCT02906358|"     The purpose of this study is to conduct a parallel group, randomized trial of primary care     clinic-based and community-based programs to educate and support low-income, Hispanic     patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.   "
28926|NCT02907021|"     Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can     cause injury to the heart, and this is one of the main reasons it cannot be administered as     planned. Heart injury can often be successfully treated using cardiac medications. The aim of     SCHOLAR is to evaluate whether it is safe to continue trastuzumab in individuals with mild or     moderate cardiac injury, while treating them with appropriate cardiac medications. In this     way the investigators hope to be able to optimise the delivery of a treatment to patients     with breast cancer that has proven survival benefits, especially when administered for a full     12-month course.   "
28927|NCT02907008|"     The aim of the study is to evaluate the impact of sleep quality on intubation rate in     intensive care units patients with acute respiratory failure   "
28928|NCT02906995|"     The purpose of the study is to compare two different dosage forms from which nicotine is     released and absorbed into the bloodstream.   "
28929|NCT02906982|"     The purpose of this study is to evaluate the efficacy of a novel gum health formulation, when     used in an intra-oral device or on a toothbrush, for teeth whitening and clinical     improvements in periodontal diseases.   "
28930|NCT02906969|"     Background:      The investigators assessed the use of a colonoscopy instructional video to improve both bowel     preparation and education prior to procedure. Preceding studies have been vague, pinning     patient education via diagrams and text as both pivotal and useless for compliance in bowel     preparations. These studies however lacked assessment of comprehension prior to procedure.      Methodology:      This is a prospective study of diverse, inner city outpatient university center, first time     colonoscopy patients given 1 of 2 on-site videos and written/verbal instruction.     Experimentals saw a 5 min video on the purpose of colonoscopy, bowel preparation,     pre-colonoscopy diet, and proper laxative use. Controls saw a 5 min video from the same     spokesperson on upper endoscopy; which was trivial. Both groups were given a quiz within 30     days of the colonoscopy on demographics, and 14 test questions about colonoscopy and     preparation. Subsequently, endoscopists used the additive Ottawa scale to rate quality of     preparation (range 0-14) via: fluid (0=sm,1=mod, 2=lg) and cleanliness in each the right, mid     and rectosigmoid colon, (0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate).   "
28931|NCT02906956|"     The purpose of this study is to explore whether adherence to upper extremity home programs     changes when persons post stroke practice with preferred music.   "
28958|NCT02906605|"     The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with     apalutamide is improved compared with apalutamide alone for subjects with metastatic     castration-resistant prostate cancer (mCRPC).   "
28969|NCT02906462|"     In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in     hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey.     Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French     hospitals and showed that their conditions of death were not optimal. The 22th April 2005     French Law precised patient's end of life rights with necessity to refrain from any     unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial     process decision when the patient is not conscious. Since then, studies haven't demonstrate     any improvement and found that palliative strategy in France is much less used than in other     developed countries.   "
29019|NCT02905799|"     The purpose of this study is to determine whether resveratrol is effective in the treatment     of painful knee osteoarthritis.   "
30249|NCT02889770|"     This studies´ objective is to describe how different PEEP levels affect dead space measured     by Bohr´s formula.   "
28932|NCT02906943|"     Substantial progress has been made in the treatment of cancer through the use of targeted     therapies, but what works for one patient might not work for another patient. Certain drugs     are now being developed that target specific molecules in the body that are believed to be     part of the disease.      Biomarkers are specific characteristics of the cancer that may help provide prognostic     information (e.g. how well patients will be regardless of the treatments given) or help     predict sensitivity or resistance to a specific treatment.      The study will collect archival tumor samples (previously collected biopsy or surgical tumor     samples) to provide biomarker data about a patient's cancer, which may help their physicians     to identify which clinical trials of new drug treatments may be most appropriate for the     patient in the future and may also guide the use of approved treatments that may potentially     benefit the patient.      Another goal of this study is to develop a province-wide registry of targeted gene sequencing     testing results that will be made available to cancer researchers. Additional tumour tissue     and blood samples collected from all study participants will also be stored in a biobank at     the Ontario Institute for Cancer Research for future research.      The study will also look at linking data from this study to other health care databases to     further collect information about the health care the patients received, including medical     tests, clinic visits, or procedures both before and after participating in this study. Having     more information about patient health to relate to the DNA sequences may provide new insights     into cancer and its treatment.   "
28934|NCT02906917|"     Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine     plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or     without oral antidiabetic treatment in need of treatment intensification.   "
28935|NCT02906904|"     Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent     and disabling sleep disorders characterized by arousal specifically from slow wave sleep     (SWS) with dissociated brain activity that may be related to lower nociceptive state. The     investigators recently reported frequent subjective complaints of chronic pain, migraine and     headache during wakefulness in adult sleepwalkers. They also described frequent analgesia     during severe and injuring episodes, suggesting a relationship between dissociated brain     activity and nociceptive dysregulation. However, this study did not included objective     nociceptive measures and the retrospective assessment of perceived pain during parasomnia     episodes over a lifetime span might also introduce a recall bias.      The aims of the present study are to measure objective pain sensitivity in patients with NREM     parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS,     and 3) wakefulness.      Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be     recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory     stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic     stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the     nociceptive threshold. During the recovery sleep following the sleep deprivation, the     investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS     and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive     responses.      The investigators hypothesized a lower nociceptive threshold during wakefulness in     sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This     study may help to better understand the etiology and mechanisms underlying the clinical     enigma of the nociceptive dysregulation in NREM sleep parasomnias.   "
28936|NCT02906891|"     A single center pilot study assessing the Vigilant Diabetes Management Companion for the     prevention of recurrent nocturnal hypoglycemia in type I diabetes patients.   "
28937|NCT02906878|"     PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion   "
28938|NCT02906865|"     Proximal hamstring rupture is a rare injury, which may be immediately diagnosed.      In 1996, Sallay showed that functional results of surgical repair were better than those of     conservative treatment. Surgery is now the rule. The main aim of this study is to obtain a     more detailed and quantified description of the postoperative outcomes.   "
28939|NCT02906852|"     The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis     compared with standard tissue biopsy analysis for detection of genomic alterations in     patients with advanced lung cancer.   "
28978|NCT02906345|"     Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled,     prospective study focusing on the organ functions of the patients.   "
28941|NCT02906826|"     An airway clearance technique (ACT) is one of the core treatments for children with chronic     lung diseases who are unable to clear their secretions effectively. Unfortunately adherence     to performing an ACT is low with a reported rate between 40 - 70%. Up to the present, there     has been no way to objectively measure adherence to an ACT. With new technology, it is now     feasible to connect an electronic manometer to an airway clearance device to objectively     measure how often the child is actually performing their ACT. The first part of this proposed     study is to objectively measure adherence against reported adherence over a 4 month period.     During the second 4 months a video game will be added to the digital manometer which only     operates if participants are performing their ACT properly. Adherence will again be measured.   "
28942|NCT02906813|"     The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram     (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of     food on the BA of TAK-935 300 mg tablets in healthy adult participants.   "
28943|NCT02906800|"     Introduction: Patients with primary unresectable advanced head and neck squamous cell     carcinomas (HNSCC) have a poor prognosis with a median survival of 22 months (Hauswald H     Radiat Oncol 2011). They are usually treated with induction chemotherapy followed by     radiochemotherapy or platinum-based concomitant radiochemotherapy. Most patients achieve an     objective clinical response contrasting with a high rate of local recurrence and distant     metastases in the year following radiochemotherapy (Argiris A Ann Oncol 2011). Improvement of     the efficacy of chemotherapy remains therefore a major clinical goal for this group of     patients. During the past years, the investigators demonstrated that some conventional     chemotherapeutics (anthracycline, oxaliplatin…) induce a type of immunogenic cell death     (ICD) characterized by the exposure of calreticulin on the tumor cell surface, the secretion     of ATP and the release of high-mobility group box 1 (HMGB1) resulting in activation of tumor     immunity (Galluzzi L Nat Rev Drug Discov 2012). The investigators recently showed that the     Na/K-ATPase inhibitor, digoxin, favors ICD, when combined with cisplatin, a drug known not to     induce ICD. In preclinical models, a synergy between cisplatin and digoxin which led to a     significant therapeutic improvement (Menger L Sci Transl Med 2012) has been observed. This     effect seems to be mediated by the immune system as the combined therapy induced intratumor T     cell infiltration producing cytokines (Menger L Sci Transl Med 2012).      Hypothesis: Based on our preclinical data, the hypothesis is that adding digoxin to the     conventional cisplatin based induction chemotherapy regimen in unresectable advanced HNSCC     will increase the efficacy of this therapy via the induction of anti-tumor immunity.      Objectives:      Main: the primary objective is to assess the clinical and biological safety of the     combination of digoxin to cisplatin-based chemotherapy.      Secondary: The secondary objectives are to investigate biological markers of efficacy by     analyzing the recruitment of functional T cells in tumour biopsies after treatment with the     combination of digoxin and chemotherapy.   "
28944|NCT02906787|"     The purpose of this research study is to better understand (1) why people gain weight when     they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking)     counseling combined with the nicotine patch help people quit smoking and gain less weight.   "
28946|NCT02906761|"     Asthma is characterized by changes in eicosanoids metabolism, especially high production of     bronchoconstrictive cysteinyl leukotrienes (CystLTBs) and leukotriene B4 (LTB4). Recent     studies have also demonstrated a relative low production of lipoxin A4, an endogenous lipid     mediator resulting from lipo-oxygenase action, distinct from CystLTBs, with anti-inflammatory     properties, in bronchial epithelial cells and lung macrophages of severe asthma patients,     leading to imbalance between pro-resolving and pro-inflammatory eicosanoids production in     airways. Such data suggest that aspirin, that induces lipoxins production, could restore     lipoxins deficit in severe asthma. Interest for aspirin is also supported by data obtained in     asthma patients with aspirin intolerance (Aspirin induced asthma, AIA) : in this particular     group of patients, aspirin treatment significantly improves nasal symptoms, quality of life,     asthma and rhinitis scores, and reduces need for hospitalizations, nasal surgery and oral     steroids use. Potential effect of aspirin in patients with uncontrolled asthma without     aspirin intolerance, who presented changes in arachidonic acid pathway close to those     observed in AIA, is not established.      The aim of the study is to assess whether long term aspirin treatment could improve asthma     control, compared to placebo, in patients with uncontrolled disease and nasal polyposis,     whatever their aspirin tolerance level.   "
28947|NCT02906748|"     The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH)     into the circulatory system of the body through the capillaries. But when parathyroid glands     were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH     to examine whether the graft functions. So the investigators took the forearm as the aim     place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively     fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the     PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and     not-grafted forearm.   "
28948|NCT02906735|"     Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of     alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a     lack of understanding what changes of alignment of the lower limb causes to the ankle. The     investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure     investigated by means of static and dynamic pedography.   "
28949|NCT02906722|"     Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by     Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active     antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin     over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.   "
28950|NCT02906709|"     This study will examine the efficacy of omarigliptin 25 mg once weekly compared to placebo in     Japanese patients with T2DM who have inadequate glycemic control on insulin monotherapy in     addition to diet and exercise therapy. The primary hypothesis of the study is that     omarigliptin 25 mg once weekly provides greater reduction in hemoglobin A1C (HbA1c) compared     with placebo as assessed by change from baseline to Week 16 [Phase A (double-blind period)].   "
29053|NCT02905357|"     The Women's HARP study is a multi-center, diagnostic observational study employing     standardized imaging protocols in women with MINOCA (MI with Non Obstructive Coronary     Arteries) to determine the underlying diagnosis in each participant. Participants will be     followed for recurrent clinical events, every 6 months, for a maximum of 3 years.   "
28951|NCT02906696|"     Bosutinib is a type of tyrosine kinase inhibitor (TKI) which is commonly used for the     treatment of chronic phase chronic myelogenous leukemia (CP CML). The standard dose of     bosutinib often causes temporary, but severe, diarrhea which goes away after bosutinib is     stopped or the dose is lowered.      The goal of this clinical research study it to learn if a lower dose of bosutinib is as     effective as the standard dose. Researchers think that by starting with a lower dose of     bosutinib and slowly increasing the dose (if needed), the likelihood and severity of diarrhea     and other side effects may be lowered in patients with CP CML.      To help researchers learn if the lower dose of bosutinib is as effective as the regular dose,     researchers will test your cytogenetic response to the drug. Cytogenetic testing looks at how     genetic changes to cells (in this study, the BRC-ABL protein and Philadelphia chromosome) may     affect how the disease may react to the study drug.   "
28952|NCT02906683|"     The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female     patients with stress urinary incontinence.   "
28954|NCT02906657|"     Context Adverse drug events (ADEs) may occur in hospitalized patients and may result from     discrepancies between patient's current medications and the drugs prescribed at admission     (omission, commission, dosing errors….). Consequences of these discrepancies may be mild     (e.g. isolated biological abnormalities), but may also lead to severe clinical outcomes.     Medication reconciliation is a process of creating the most accurate list of patient's     current medication in order to decrease discrepancies and eventually ADEs. Information     technology and electronic health records are of great interest in this process. In France,     medications dispensed in community pharmacies during the past 4 months are registered in     patient's electronic pharmaceutical record. The impact of this record together with a     pharmacist medication reconciliation will be tested in the CONCIPAGE study.      Design The CONCIPAGE study is a national, multicenter, cluster-randomized, two-period     cross-over study. It will estimate the impact of a medication reconciliation, made by a     pharmacist, using patient pharmaceutical record, on the occurrence of ADEs during the     hospitalization of patients aged 65 years and over.      Fifteen hospitals gathering 20 centers (8 geriatric departments, 8 internal medicine     departments, and 4 orthopedic surgery departments) will participate in the study. An     equilibrated randomization will be applied to the 20 centers. The recruiting period will last     for 24 months and will be divided into four 6-month consecutive periods (A, B, C, D). During     the first 6-month period (period A), 5 centers (1 to 5) will apply one strategy (intervention     or usual care) while 5 others (6 to 10) will apply the alternative strategy. Centers 11 to 20     will not recruit patients during period A. During the next period (period B), centers 11 to     15 and 16 to 20 will apply the intervention or the control strategy, while centers 1 to 10     will apply a 6-month wash-out period. During period C, centers 1 to 10 will apply the     alternative strategy as compared to that applied during period A (cross-over design), while     centers 11 to 20 will apply the 6-month wash-out period. During period D, centers 11 to 20     will apply the alternative strategy as compared to that applied during period B, while     centers 1 to 10 will not recruit patients during period D.      Description of the intervention During the control period, no intervention will be held. The     prior to admission medication list will be made as usual by the hospital physician: interview     of the patient and relatives, prescriptions brought by the patient, call to community     physicians and pharmacists, hospital medical records, etc. This process will result in a     medication prescription list at admission.      During the intervention period, a local hospital pharmacist will independently perform an     additional (i.e. to that made by the hospital physician) prior to admission medication list,     using the above-mentioned sources and in addition, with the help of the electronic     pharmaceutical record. The medical reconciliation in the intervention period consists in the     comparison of the pharmacist's and physician's prior to admission medication lists. Such a     reconciliation might lead to a modification of the medication prescription that was made by     the physician at admission.      Patient follow-up Patients will be included the day of admission and will be followed-up up     to 30 days. A study pharmacist will be enrolled and will be in charge of collecting follow-up     data for all patients. The study pharmacist will visit centers 2, 4, and 7 months after the     beginning of each period. He/she will study the record of each patient included in the study,     and will collect all potential biological or clinical abnormalities, prescriptions of     antidotes and diagnostic imaging, transfer to ICU, death.      Objectives The primary objective of the study is to assess the impact of medication     reconciliation by a pharmacist using usual sources plus the electronic pharmaceutical record     on ADEs occurring in hospital settings.      The secondary objectives are the following:        -  To assess severity and preventability of ADEs in both groups.        -  To assess the distribution of ADEs in both groups.        -  To compare the 30-day mortality rates observed in the two groups.        -  In the intervention group only, to assess the rate of intentional (treatment          modification intended by the physician) and unintentional discrepancies between the          prior to admission medication list made by the pharmacist and the hospital physician's          prescription at admission.        -  In the intervention group only, to assess the rate of discrepancies between the hospital          prescription at admission and the prescription after medical reconciliation.        -  To estimate the cost-effectiveness of the intervention.   "
28955|NCT02906644|"     This study plans to compare the efficacy of the nicotine patch / lorcaserin combination     treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior     and withdrawal symptoms.   "
28956|NCT02906631|"     Introduction: Acute encephalitis (AE) is a severe neurological disorder associated with     significant morbidity and mortality. Approximately 50% of patients with AE require ICU     admission because of coma, seizures or acute respiratory failure. Determinants of     neurological prognosis in these patients are not known.      Objectives:      Main objective: To identify determinants of outcome in adult patients admitted to the ICU;     Secondary objectives: a) To study the impact of diagnostic studies (Brain MRI, CSF analysis,     EEG) on neurologic outcome; b) to describe the epidemiology of patients admitted to the ICU     with AE; c) to study the impact of early appropriate therapy on neurologic outcomes; d) to     describe morbidity and mortality associated with AE at 90 days and 1 year following     diagnosis.      Methods: prospective observational multicenter study in French ICUs. All patients admitted to     the ICU for probable or confirmed AE (2013 IDSA criteria)with a Glasgow coma scale score < or     =to 13 will be eligible for inclusion. Factors associated with a poor prognosis at 90 days     will be identified by multivariable logistic regression analysis.      Duration of study: 30 months (recruitment 18 months, follow-up 12 months).      Patients: 300 patients      Endpoints:        -  Primary endpoint: The primary endpoint is the modified Rankin scale score 90 days          following onset of abnormal status (GCS < or =13). This score will be determined by          contacting the patient. A poor outcome will be defined as a mRS >2 at 90 days.        -  Secondary endpoints: a) neurological findings within 7 days following onset of altered          mental status; b) abnormal findings on diagnostic studies (MRI, EEG, CSF analysis)          within7 days following onset of altered mental status; c) Time between onset of altered          mental status and completion of diagnostic studies; d)Time between onset of altered          mental status and start of appropriate specific therapy; e) neurologic outcomes at 1          year mRS score and extended Glasgow outcome scale (GOS); f) causes of death in          non-survivors at 1 year; g) quality of life and posttraumatic stress at 1 year: IADL and          SF36 scales;   "
28957|NCT02906618|"     The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion     (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this     study will help to answer the following research questions:        -  How much LY3039478 gets into the blood stream when given by mouth as a capsule compared          to when given by an IV        -  How long it takes the body to remove the study drug        -  The safety of LY3039478 and any side effects that might be associated with it      Participation in the study is expected to last up to 7 weeks. There will be screening, a     single study period, and a follow-up.   "
28959|NCT02906592|"     The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a     community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the     Duke Cancer Network, located in the rural, low resource Scotland County community of North     Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by     comparing historical and post-GOA service referral patterns and adherence to planned cancer     therapy. For this study, the investigators will prospectively enroll up to 60 patients who     have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to these     60 patients, the investigators will also conduct retrospective chart reviews on 120 patients     that would be eligible for this study to evaluate past referral patterns. Eligible and     consented patients will complete the brief GOA at the Scotland Cancer Treatment Center     alongside their normal clinic appointment. The investigators will assess impact on the     healthcare system by evaluating referral patterns (i.e., how many, what type of services)     using the brief GOA data and EHR data. The study value includes the possibility for     recognition and access to additional health care referrals if needed.   "
28960|NCT02906579|"     To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT     to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.   "
28961|NCT02906566|"     There has been increasing evidence for different rates of natural aging in humans and one of     the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of     topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or     vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally,     studies of retinol in humans have largely occurred in white populations and so this study     aims to focus on skin aging in individuals of East Asian descent as they represent a majority     of the world population. This study aims to better characterize the molecular basis of     rejuvenation effects and to potentially discover new topical agents with similar and/or more     effective preservation of skin youthfulness.   "
28962|NCT02906553|"     This study evaluates the role of the Nitric Oxide system in cognition in patients with     schizophrenia. Participants will be randomised to 2 equal groups and receive either the     Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several     cognitive tasks will be assessed.   "
28963|NCT02906540|"     To verify the efficacy of transpubic symphysis reset therapy for low back pain, and provide     support for the clinical application of this treatment.   "
28979|NCT02906332|"     This is an open-label, Phase II, single center trial of pembrolizumab (MK-3475), lenalidomide     and dexamethasone in subjects with high risk Multiple Myeloma (hrMM) post high-dose     chemotherapy with autologous stem cell transplantation (ASCT).      Patients with high-risk MM defined as those with one of the following abnormalities who have     undergone induction therapy followed by single or tandem melphalan -based ASCT will be     considered eligible.   "
28964|NCT02906527|"     The aim of the study is to compare, in real life, the risk benefit (including both major     bleeding and thrombotic events (TE) and death from any cause) associated with direct oral     anticoagulants (DOAC) and with anti vitamin K (VKA) in older adults (≥ 75 years) suffering     from nvAF.      The study will be conducted in the French Health insurance database (SNIIRAM). Data of octo+     patients newly treated with an oral anticoagulant (VKA or DOAC) for non valvular atrial     fibrillation (nv AF) will be collected from the first exposure of the patient to the drug of     interest during the inclusion period to the end of the follow-up period (at least one year of     follow-up for each patient).   "
28965|NCT02906514|"     Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity     of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.      The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective     than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic     effect.   "
28966|NCT02906501|"     Introduction: The use of low dose risperidone and other antipsychotic drugs off-label as     augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD)     and Disruptive Behavioral Disorder (DBD) has become widely common worldwide, usually to help     control behavioral difficulties. While some argue that agents that block dopaminergic     receptors may have a deleterious cognitive effect, others stress their moderating effects,     which possibly improve function in all domains, including cognitive functions. Only a few     studies have examined this topic, with inconclusive results.      Aim of study: To measure the effect of risperidone treatment on various cognitive functions     in a population of ADHD diagnosed children and adolescents with normal IQ.      Design: The study is an observational prospective open label clinical controlled trial. The     investigators will compare the performance in a battery of cognitive tasks using the Penn     Web-Based Computerized Neurocognitive Battery (WebCNP) and the IGT, in children and     adolescents diagnosed with ADHD, with and without risperidone.      Study population: Children and adolescents diagnosed with ADHD, 8-17 years old, may be     eligible for this study. We will recruit subjects who their psychiatrist is considering     rispieridone treatment, those who are already treated with risperidone and subjects with only     stimulants treatment. All pharmacological treatment is supervised and prescribed to subjects     by their personal psychiatrist unrelated to the study.      Significance: Better knowledge of the specific cognitive effects of this form of therapy will     help us guide both clinical decisions, and recommended monitoring in daily clinical work.   "
28967|NCT02906488|"     The purpose of this study is to assess the safety and efficacy of long-term use of Duodopa in     patients with Parkinson's disease in actual usage   "
28968|NCT02906475|"     The primary objective of this study is to investigate the effectiveness of a standardized     skin care regimen using a milk lotion once daily and a bathing addendum as needed during the     first 52 weeks of life on the development of atopic Dermatitis (AD) compared to no structured     skin care regimen in infants with atopic predisposition. Secondary objectives are to     investigate the influence of a structured skin care regimen on the development of AD in the     second year of life and the skin barrier function up to the infants' age of 2 years.   "
28990|NCT02906189|"     The primary objective of the study is to determine the safety of MRI in patients with non-MRI     conditional pacemakers. The secondary objective is to determine if there are clinically     relevant parameter changes in the devices.   "
28991|NCT02906176|"     A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic     characteristics of voriconazole in CYP2C19 poor metabolizers   "
28970|NCT02906449|"     The primary purpose of this study is to investigate the effectiveness of a brief     mindfulness-based intervention for targeting chronic physiological underarousal and     post-concussive symptoms following a mild head injury (MHI), as self-reported by     undergraduate university students. For the purposes of this study, MHI is defined (and     identified) through our demographic questionnaire as a traumatic-based injury to the head -     Have you ever hit your head with a force sufficient to alter your state of consciousness     (consistent with the Kay et al., 1993 criteria/definition; American Congress of     Rehabilitation Medicine - ACRM). The investigators exclude congenital or genetic injuries.   "
28971|NCT02906436|"     Only about 15% of the potential candidates for lung donation are considered suitable for     transplantation. Thus, a strategy that could improve the quality and precision of assessment     of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality     while on the list.      A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and     colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also     be used to recondition marginal and nonacceptable donor lungs.      After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular     matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit     received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous     blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and     ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular     resistance (PVR), lung compliance (LC), and biopsy.   "
28972|NCT02906423|"     The purpose of this retrospective chart review pilot study is to research the results and     scores of the QOL questionnaire implemented across Allina Health clinics. This study will     investigate average QOL scores by clinical population and demographic group, the change in     scores over time, and the effect of clinical interventions on QOL scores. The results will     provide insight into QOL trends within different patient populations and provide guidance     regarding optimal treatment plans so that Allina caregivers can positively impact patients'     QOL.   "
28973|NCT02906410|"     Participants will be asked to select a hypothetical lunch from a menu that features entrees,     sides, and drinks. Participants will be able to select a maximum of 1 item from each     category. Following this meal selection, participants will complete a short survey about     their demographics, their estimates of information about the meal and about recommended     eating habits.   "
28974|NCT02906397|"     To determine the safety and tolerability of galunisertib when combined with Stereotactic Body     Radiotherapy (SBRT) (hypofractionated radiation).   "
28982|NCT02906293|"     This study seeks to: Assess normal intestinal event rates for healthy subjects, to     determine the effect of meal size on an individual's intestinal rate, and to determine     whether there are differences between individuals in the fasting and post-prandial setting.      The investigators hypothesize the following:        1. Fasting intestinal rate will be consistently less than 14 events per minute, similar to          previously documented bowel sound frequency.        2. There will a uniform increase in intestinal rate in the immediate post-prandial setting.          There will be direct correlation between maximal and average post-prandial intestinal          rates and meal size. Likewise, meal size will correlate with time to baseline fasting          intestinal rate.        3. Males and those with lower body mass index (BMI) will experience higher maximal and          average post-prandial intestinal rates and shorter time to baseline fasting levels          compared to females and those with higher BMI, respectively.   "
28983|NCT02906280|"     EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A     limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure     adequate histological samples. Although a larger 19 Ga needle can procure histological     samples as demonstrated by the conventional 19 Ga needle, published data are not existing     with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed     for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the     recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the     performance of both needle types.   "
28984|NCT02906267|"     This study is designed to evaluate the occurrence of gastric insufflation and the critical     volume of the stomach after three different modes of positive pressure ventilation during     induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)   "
28985|NCT02906254|"     Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be     responsible for side-effects and selection of resistance. This study demonstrates the safety     of an early discontinuation of empirical treatments, in carefully selected patients     presenting with fever of unknown origin.   "
28986|NCT02906241|"     This research has the overall goal of increasing rates at which African American and White     men with prostate cancer make an informed decision to participate in a cancer clinical trial.   "
28987|NCT02906228|"     The purpose of this study is to investigate possible effects of radio frequency     electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in     the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive     performance measures in test of selective attention, divided attention and working memory in     healthy elderly females (60 - 80 years).   "
28988|NCT02906215|"     Many people living with HIV use illicit drugs and require treatment for both HIV and drug     use, however, many barriers exist which prevent integration of dual care services. This study     will develop a novel intervention aimed at the provider-level which will combine an     evidence-based training model with use of mobile technology to improve care coordination     between providers at HIV clinics and substance use treatment facilities. If proven effective,     this intervention may be widely disseminated and easily implemented into existing clinic     structures, thereby improving care coordination among providers and linkage to dual treatment     for HIV-infected people who use drugs.   "
28989|NCT02906202|"     This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 15 subjects ≥12     and ≤50 years of age with transfusion-dependent β-thalassemia (TDT), also known as     β-thalassemia major, who do not have a β0 mutation at both alleles of the hemoglobin β (HBB)     gene. The study will evaluate the efficacy and safety of autologous hematopoietic stem cell     transplantation (HSCT) using LentiGlobin BB305 Drug Product.   "
28994|NCT02906137|"     The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were     receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the     gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis     axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to     reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected subjects.This     study aims at better understanding the mechanisms involved in this lack of mucosal immune     restoration.   "
28995|NCT02906124|"     To evaluate outcomes of pregnancy in females diagnosed with familial hypercholesterolaemia     (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the     age of 12 months   "
28996|NCT02906111|"     The purpose of this study is to determine whether the vaginal estriol before vaginal surgery     for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and     quality of life.   "
28997|NCT02906098|"     This study evaluates behavioral interventions to increase adolescent's motivation for self     performed periodontal infection control, by means of adequate oral hygiene. Study subjects     will be allocated to test and control group where the test will be subjected to an     individually tailored oral health education program, based on cognitive- behavioral theory     and principles, and the control to standard educational intervention.   "
29082|NCT02904980|"     The aim of this study was to integrate a gaze training intervention (i.e., quiet eye     training; QET) that has been shown to improve the throwing and catching skill of children     with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that     might alleviate the psychosocial influence of these motor skill deficits.   "
28998|NCT02906085|"     One third of migraine patients experience aura, i.e. dramatic, transient neurological     symptoms, most often in the form of visual disturbances, that usually appear before the onset     of migraine headache. The likely underlying mechanism of aura is known as cortical spreading     depression, a wave of changes in electrical activity that slowly spreads in the outermost     layer of the brain. It is currently not known what causes the aura to initiate in patients or     what the relationship is between aura and migraine headache, e.g. if treatment targeted at     aura mechanisms will prevent subsequent headache. Due to the short-lasting and unpredictable     nature of aura, the only possible approach for systematic investigations is to experimentally     trigger aura, but currently no method for aura-triggering is available.      The overall goal of the proposed project is to reveal the earliest mechanisms of the migraine     attack by investigating the initiating factors of aura in the migraine brain.      Current animal evidence indicates that infusion of endothelin-1 (ET-1), a naturally occurring     signaling molecule released from blood vessels, is safe and very likely to trigger migraine     aura in patients.      In this project the investigators aim to study the effects of ET-1 on the human brain, to     investigate aura-inducing effects of ET-1 in patients and to develop a safe and reliable     method for the experimental induction of migraine aura using ET-1.   "
28999|NCT02906072|"     The effect of a diet free from animal-sourced nutrients on body composition in weight     reduction programs is not well established. In this non-randomised free living interventional     case-control study, the investigators will document the effects of a 10-week, low-fat,     plant-based diet supplemented with two daily plant-based meal replacements on body     composition indices measured with bioimpedance analysis. Control subjects will be exposed to     weekly lectures on the rationale and expected benefits of plant-based nutrition. The     investigators hypothesise that low-fat plant based diet supplemented with meal replacements     eaten ad libitum allows a significant reduction of body fat without the loss of lean tissue.   "
29000|NCT02906059|"     The purpose of this study is to determine whether combination therapy of irinotecan with     AZD1775 is safe and effective in treating mutated metastatic colorectal cancer patients.   "
29001|NCT02906046|"     Few studies evaluated the efficacy of adding weights on the lower limbs in patients with     ataxic disorders. There is no current evidence on which would be the most appropriate weight     for use in this context. To assess progress and benefits of using this load, gait of     symptomatic carriers of spinocerebellar ataxia type 3/Machado Joseph disease the objective of     the study is to evaluate the gait with and without different load weights on lower limbs.     Outcomes were the Scale for the Assessment and Ataxia Rating of (SARA), kinematic gait     assessment by the accelerometer and gyroscope and the Patient Global Impression (PGI) about     which weight they prefer for walking.   "
29002|NCT02906033|"     The aim of the study is to improve the surgical patients' care process. The objective is to     explore the effect of a new perioperative practice model on 1) patient outcomes     (satisfaction, surgery-related anxiety and quality of life), 2) nursing outcomes     (organizational engagement), and 3) organization outcomes (timeline of surgical care     process).   "
29003|NCT02906020|"     Primary Objectives:        -  Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally, as          compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a GBA          mutation or other pre-specified variants.        -  Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared          to placebo in patients with early-stage Parkinson's disease carrying a GBA mutation or          other pre-specified variants.      Secondary Objectives:      Part 1:        -  To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR4027671 in plasma          when administered in early-stage Parkinson's disease patients carrying a GBA mutation.        -  To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in          early-stage Parkinson's disease patients carrying a GBA mutation.      Part 2:        -  To demonstrate overall safety and tolerability of GZ/SAR4027671 administered orally in          early-stage Parkinson's disease patients carrying a GBA mutation as compared to placebo.        -  To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma          and CSF as measured by glucosylceramide (GL-1) when administered in early-stage          Parkinson's disease patients carrying a GBA mutation.   "
29004|NCT02906007|"     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability     of an antituberculosis drug, bedaquiline (BDQ), when used to treat multidrug-resistant     tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected infants, children, and adolescents.   "
36713|NCT02805127|"     This is an observational study which aims to evaluate the possibility of using data from a     capnography device to assess obstructive airway severity in both Chronic Obstructive     Pulmonary Disease (COPD) and Asthma patients.   "
29008|NCT02905955|"     All patients with deep venous obstruction below the sapheno-femoral junction elective for     hybrid procedure with creation of an arterio venous-fistula (AVF) in the MUMC or patients     with primary percutaneous procedure (and thus venous obstruction above the sapheno-femoral     junction) who present with occluded stents which need an additional AVF after thrombolysis     will receive a Prevena NPWT. Incidence of wound infections and wound scoring will be     performed afterwards.   "
29009|NCT02905942|"     The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the     recovery of hematopoietic function after autologous stem cell transplantation in patients     with lymphoma.   "
29010|NCT02905929|"     Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA)     Women's Health Program will assess 3-month changes in sitting time, standing time, physical     activity and blood pressure in a randomized control trial. This 2-arm randomized controlled     trial (RCT) will occur in the community with post menopausal Latina women (N=250) who spend     at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high     BMI and borderline hypertension. Women will be identified through the San Ysidro Health     Clinic and assessed at the South Bay Latino Research Center.   "
29012|NCT02905903|"     Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after     cutaneous inflammation or injury that frequently affects darker skinned populations.     Previously, a model of 35% TCA-induced PIH was validated against acne induced PIH, which has     value in product testing for the treatment of PIH. In this second phase of the study, the     investigators would like to determine if a lower concentration of TCA-induced PIH is     comparable to acne-induced PIH.   "
29013|NCT02905890|"     The proposed study, Hormonal Contraception & BV (HCBV), will investigate the effect of NET-EN     and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high     risk for HIV in Kampala, Uganda. The hypothesis is that NET-EN will show a similar beneficial     effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of mucosal     inflammation.   "
29014|NCT02905877|"     Functional disorders, also called psychogenic or psychosomatic are very common, disabling and     their costs to society are immense.      Functional movement disorders are abnormal, involuntary movements, that are illogical in     terms of classic neurology. Intriguingly, they typically manifest when patients pay attention     to them and disappear with distraction.      The investigators aim to further the understanding of the pathophysiological mechanisms     underlying functional neurological disorders in order to improve treatment. In particular     they aim to understand the effect of attention on movement in general, on functional     neurological mechanisms and on the sense of agency (of subjective control) over a movement.      Patients with a functional neurological disorder, patients with an organic neurological     disorder and healthy participants will perform simple tasks, such as reaching to a target,     while additional tasks will manipulate their attention. The effects of these attentional     manipulations will be analysed on several levels: movement performance, analysed by the     kinematics and electromyography (EMG), psychophysical measures, such as the sense of agency,     and the neural correlates with functional magnetic resonance imaging (fMRI).      If the hypothesis turns out to be true, then changing the attentional focus could be used as     a treatment in functional neurological disorders.   "
29015|NCT02905864|"     A randomised, double blind, placebo-controlled, parallel group, and single-centre trial     investigating the effect of liraglutide on body weight and pain in overweight or obese     patients with knee osteoarthritis.      Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a     low-calorie diet and dietetic counselling. At week 0 patients will be randomised to receive     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on     re-introducing regular foods and a focus on continued motivation to engage in a healthy     lifestyle.   "
29016|NCT02905851|"     To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline     or minocycline for acne vulgaris   "
29017|NCT02905838|"     To assess and compare the esthetic outcome and clinical performance of anterior maxillary all     ceramic implant single crowns based either on prefabricated zirconia abutment veneered with     pressed ceramics or on a CAD/CAM (computer-aided design and computer-aided manufacturing)     CARES® abutment veneered with hand build-up technique.      Participants will be recruited from the patient population who has previously received dental     implant treatment, received a provisional restoration and met the inclusion and exclusion     criteria according to the study protocol. After final impression, patients will be randomised     into Group A (prefabricated anatomic abutments ): one-piece screw retained single crown using     a press technique (fluorapatite glass-ceramic, e.max ZirPress) with cut-back technique or     Group B (CAD/CAM CARES® abutments): one- piece screw retained single crown with a hand     build-up technique (fluorapatite veneering ceramic, e.max Ceram). One week after final     restoration (base line visit) the primary and secondary outcome parameters will be assessed.     The patients will be followed up to 5 years after final restoration.   "
29018|NCT02905812|"     Methodology: Pilot randomized controlled trial with 1 intervention and 1 parallel standard     care group to assess the feasibility and treatment effect of a multimodal integrative     intervention for delirium prevention and associated detrimental effects.      Duration: 2 years, two months. Study Center(s): Multi-center (2 sites) Aim: To assess     feasibility and measures of effect of a multimodal intervention consisting of relaxation with     guided imagery (RGI), and moderate pressure massage on physiological and psychological     outcomes of critically ill patients.      Objectives: a) assess clinical trial feasibility with pre-defined goals (enrollment,     randomization, adherence, timing of intervention, workload), b) calculate estimates and     variance of treatment effect across outcome measures, c) calculate confidence intervals (CI)     of incidence proportions, means and standard deviation (SD) of outcome measures in study     groups., d) explore underlying physiological mechanisms of efficacy Number of Subjects: 60     participants per arm. Total: 120 participants Diagnosis and Main Inclusion Criteria: Critical     illness Inclusion criteria: a) Age over 18 years, b) ICDSC:0-3. Exclusion Criteria: Patients:     a) with expected ICU LOS< 72 hours, b) with acute neurological illness/ trauma, persistent     sedation or coma, c) with current history of severe mental health problems and dementia, as     per history and psychiatrist assessment, c) with hearing impairment or conditions not     permitting use of headphones, e) on neuro-muscular blockers, f) with substance/ alcohol     withdrawal, g) enrolled in trials of sedatives, antipsychotics.      Intervention: REPOSE intervention (a multimodal relaxation intervention) It includes: a)     relaxation and guided imagery (RGI) (40 min, headphones), b) a brief moderate pressure     massage session (massage: 15 min). RGI involves: a) guided relaxation, b) a structured guided     imagery script and c) music for 15 min (Mozart piano sonata KV283, G major (2 3) II Andante).     Duration of administration: Up to 5 days while participants still in the ICU.      Reference therapy: Standard care plus placebo to maintain blinding. Statistical Methodology:     Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on     generalized estimating equations (GEE) with AR(1) correlation structure. Confidence intervals     will be presented with estimated effects. Primary analysis will be based on all available     data utilizing data from all assessments.   "
29020|NCT02905786|"     Heart failure (HF) imposes a burden for patients and health economics. Although guidelines     exist, they are not implemented as such in the Belgian health care system. General     practitioners (GPs) are confronted with the broadest range of HF management. Therefore, a     multifaceted intervention will be implemented in Belgian general practice to support GPs in     the implementation of evidence-based HF guidelines. This multifaceted intervention will     consist of audit and feedback as a method to detect unrecognized HF patients and increase     awareness for proactive HF management. Additionally, a NT-proBNP point-of-care test will be     offered to every practice to improve detection and adequate diagnosis of HF patients.     Furthermore, a specialist HF nurse will assist GPs in education of patients, optimization of     treatment and transition of care. The investigators' aim is evaluating the feasibility of the     implementation of this multifaceted intervention in general practice and the evolution in     predefined quality indicators.   "
29846|NCT02895009|"     The purpose of the study is to investigate the protective effects of short term TR Band     compression on transradial coronary occlusion after transradial coronary intervention.   "
29021|NCT02905773|"     The aim of this study was to evaluate the intensity and duration of postoperative pain after     the removal of root canal filling material in retreatment procedures of upper incisor teeth     with chronic apical periodontitis, using different techniques.      The patients were assigned to three groups of 45 patients, according to the method used to     remove old canal filling material. The presence of postoperative pain was assessed after 6,     12, 24, 48, and 72 hours, 7 days, and finally after 10 days.      The hypothesis of this study: there would be no difference in postoperative pain intensity     among the groups.   "
29022|NCT02905760|"     Right ventricular necrosis increases patient in hospital mortality and can be observed in     20-50% of patients admitted for during acute myocardial infarction. Current guidelines     recommend managing cardiogenic shock related to right ventricular necrosis by optimizing RV     load using fluid expansion and if insufficient adding inotropic support. However, several     experimental studies reported a potential deleterious effect of right ventricular dilation     related to fluid expansion because right and left ventricular interaction decreases stroke     volume and cardiac output. Consistently with these finding, a study on a small patient sample     conducted at Henri Mondor Hospital demonstrates the safety and efficiency of furosemide in     patients with right ventricular necrosis.      The present study is a phase 3, interventional, prospective, randomized, multicenter,     double-blind analysis by intention to treat.      The main objective is to demonstrate improved hemodynamic parameters in the short term in     patients admitted for acute myocardial infarction with extension RV treated with furosemide.      The primary endpoint is compare the change in cardiac output in patients admitted and treated     by either fluid expansion or furosemide.      The study population will consist in 88 patients and the duration of subjects' participation     will be one month.   "
29023|NCT02905747|"     The aim of the project is to investigate effects of medical exercise therapy (MET) on     patients with knee osteoarthritis. MET is a common physical therapy intervention, and the     project aim to strengthen the evidence of this intervention. An experimental cohort design is     chosen, and 20 participants will be followed for 6 months. Assessments will be clinical     tests, questionnaires and accelerometer measurements before, during, and after a 3 month     period of exercise (3 days per week) with a physical therapist. The project will answer if a     3 month physical therapy intervention using MET causes changes in pain level, function and     activity level for patients with knee osteoarthritis. In addition, it will investigate     whether a single global endurance workout for 30 minutes will have an effect on pain level     for these patients   "
29024|NCT02905734|"     Tobacco use affects more than 50% of adult arrestees, of which 70% are dependent on nicotine.     However, they have no access to tobacco during detention in police cells. Nicotine withdrawal     symptoms, that include irritability, anxiety and lack of concentration, may worsen the     arrestee's health status during detention. Nicotine withdrawal is a treatable condition.     Validated treatments in other situations than police custody include nicotine replacement     therapy.      This study is based on the following hypotheses: Manifestations related to nicotine     withdrawal could increase the discomfort due to detention in police cells, A nicotine     replacement therapy initiated during detention could improve the course of detention in     police cells and could be useful in a perspective of long-lasting smoking cessation.      The primary objective is to evaluate the efficacy of nicotine replacement therapy among     nicotine-dependent arrestees on the course of detention as perceived by the arrestees. Our     secondary objectives are to evaluate the efficacy of nicotine replacement therapy on desire     to smoke during detention in police cells and to improve long-term smoking cessation among     dependent smokers.      Interventions consist in the single administration of an active treatment (nicotine patch) or     of a control treatment (placebo patch). Evaluations will include the results of a medical     examination during detention, a self evaluation by the arrestees of their desire to smoke,     and medical consultations and evaluations of tobacco use 7-10 days, one month and six months     later.   "
29025|NCT02905721|"     Spectral cardiac CT scan performed in an emergency setting in patients with suspected acute     myocarditis and presenting one selves with an acute chest pain, allows the non-invasive     assessment of both the coronary arteries and the myocardium. Delayed iodine contrast-enhanced     CT imaging should show the inflamed area with an increased uptake of iodine contrast agent in     the interstitial space, such as the well-known hypersignal seen on the myocardial delayed     enhancement sequence with MRI (corresponding of an uptake of gadolinium contrast agent in the     abnormal myocardium).      This technique has the potential to replace MRI, thus allowing the diagnosis of acute     myocarditis with a rapid and easily accessible technique. Moreover, it has the additional     benefit of avoiding invasive coronary angiography in the specific population of patients     without any significant risk factors of atheromatous disease.   "
29026|NCT02905708|"     Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative,     Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack     Construction, With a View to Maintaining Normothermia During the Peri-operative Period   "
29075|NCT02905071|"     The main objective of this work is to explore the psychometric properties of scale of     well-being at work called Serenat in order to validate it. Secondary objectives are to     study the influence of socio-demographic characteristics of the subjects on the results of     Serenat and to describe the results on subjects monitored among an adult psychiatric     population.   "
29027|NCT02905695|"     The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local     infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree     tear. The pain intensity is measured in immediate postpartum period by using a numerical     rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest,     defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are     also evaluated at each time.   "
29028|NCT02905682|"     The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for     the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of     treatment.   "
29029|NCT02905669|"     Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a     promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus     function. It allows the measurement of esophageal and pylorus distensibility as well as     contractile activity in response to distension. Examination is useful performed under     sedation. General anesthesia might affect distensibility values. The aim of this study is to     normal values for esophageal, esophago-gastric junction and pylorus distensibility in     controls during an upper gastro-intestinal endoscopy performed under general anesthesia.   "
36022|NCT02814279|"     The aim of this study was to compare clinical, esthetic and patient-centered outcomes of     coronally advanced tunnel (TUN) and coronally advanced flap (CAF) both associated with     connective tissue graft (CTG) in the treatment of gingival recession.   "
29030|NCT02905656|"     To our knowledge, no study has evaluated the independent effects of motivational interviewing     and rate reduction, individually versus in combination, for motivating smokers who are not     ready to quit (SNRTQ) to increase both quit attempts and tobacco abstinence. Given the     disseminability and the fact that findings can be readily translated into the network of     tobacco quitlines, we propose: (1) To test a tobacco quitline for SNRTQ, following methods     that we have previously implemented and evaluated (HL-123978, CA-127964); (2) To randomize     828 SNRTQs to: (a) Brief Advice + typical smoking cessation resources (control group); (b)     motivational interviewing format recommended by the Clinical Practice Guidelines; (c)     behavioral and pharmacologic rate reduction, and (d) both motivational interviewing and     behavioral and pharmacologic rate reduction. This design allows us to evaluate the     independent and additive effects of motivational interviewing and rate reduction on quit     attempts and smoking cessation.      We plan to evaluate the efficacy of the intervention utilizing point prevalence at the     12-month follow-up. The Society for Research in Nicotine and Tobacco consensus paper     concluded that point prevalence (7 days without a cigarette, not even a puff) is an     appropriate measure in measuring long term outcome in cessation induction trials. Prolonged     abstinence at the 12-month follow-up and quit attempts at the 2-, 4- and 6-month and the     12-month follow-up are secondary endpoints. Self-efficacy, level of smoking reduction,     tobacco dependence, intentions, motivation, and confidence to quit, and intervention     adherence (# sessions attended, amount of nicotine replacement therapy used) will be tested     as important treatment mediators.   "
29031|NCT02905643|"     One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade     4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all     gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates     and median patient survival of just 12-15 months post-diagnosis. Treatment response is     assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance     images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes     which, like actual tumor progression itself, demonstrate contrast enhancement on the first     post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of     treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard     noninvasive tool for distinguishing between pseudoprogression and progressive disease.     Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits     measurement of hemodynamic imaging variables. Previous literature reports attempted to use     some or all of these metrics to assess their utility in distinguishing PsP from true cancer     progression. These studies showed mixed results, likely due to a number of factors, including     poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and     varied analysis methodologies. The investigators aim to address these issues in this study.   "
29032|NCT02905630|"     This pilot study evaluates the effect of exercise training on CFR, functional capacity, heart     rate variability, endothelial function and quality of life in patients with no obstructive     coronary artery disease and angina.   "
29033|NCT02905617|"     A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast     Implants   "
29034|NCT02905604|"     The primary objective is to evaluate if repetitive transcranial magnetic stimulation (rTMS)     with theta burst frequency over dorsomedial prefrontal cortex (DMPFC) is an effective     treatment for negative symptoms (anhedonia and avolition) in schizophrenia or depression.     Other objectives are to increase the understanding of the underlying neurobiology of negative     symptoms and the mechanisms for the treatment effect of rTMS.   "
29035|NCT02905591|"     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy     for non-small cell lung cancer. The standard therapy is radiation therapy combined with     carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose     ascorbate in addition to the standard therapy.   "
29036|NCT02905578|"     This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for     metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). All subjects receive     high-dose ascorbate in addition to the standard treatment.   "
29037|NCT02905565|"     This will be a randomized, double-blind, placebo-controlled, add-on to standard-of-care study     with a primary objective to assess the safety of NBP treatment in patients with mild to     moderate acute ischemic stroke. The secondary objectives include determination of PK profile     and exploratory evaluation for the efficacy of NBP treatment in stroke patients.   "
29076|NCT02905058|"     IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix     and straighten the uterus for proper insertion; trans-cervical actions including measuring     uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the     device in the uterus.   "
29038|NCT02905552|"     Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow     failure and by a disorder of the medullary production which is a pre-leukemic state which can     evolve into acute myeloid leukemia.      The risk of leukemic transformation is estimated by the score IPSS (International Prognostic     Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic     transformation (IPSS=1,5).      Besides the risk of leukemic transformation, MDS much be complicated of infections which     could be life-threatening.      The risk of developing first infection after the diagnosis of MDS of high risk is probably     influenced by anamnestic (disease duration, comorbidities), clinical (veinous central     catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin)     and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions,     anti-infectious preventive treatment) factors. Their identification will allow for improved     targeting of the population which is is likely to benefit from anti-infective prophylaxis     Primary objective is to identify risk factors associated with first acute episode of     infection in patients with MDS, by comparing index cases and matched control cases who did     not develop infection episode since diagnosis.      Secondary objectives are to explore nature and severity of infectious episodes, number of     recurrences during 1 year of follow up and survival at 6 and 12 months   "
29039|NCT02905539|"     The purpose of this study is to determine to what extend a treatment with the iron compounds     Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study     the potential clinical impact of hypophosphatemia.   "
29116|NCT02904538|"     Both perineural and systemic dexamethasone administration allows an increase in analgesic     duration of regional anesthesia.      There is a lack of data to determine wich route allows a longer analgesic effect.      This study aims to determine wether perineural dexamethasone allows a longer analgesic     duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for     front foot surgery.   "
29040|NCT02905526|"     This randomised controlled trial will establish the effect a contraceptive intervention     delivered by mobile phone app instant messaging on use of effective contraception in Bolivia.     Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y     Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages     a day for 4 months (intervention). Participants will complete a questionnaire at baseline and     4 month follow-up.   "
29041|NCT02905513|"     This randomised controlled trial will establish the effect a contraceptive intervention     delivered by mobile phone app instant messaging on the acceptability of effective     contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to     the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app     plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a     questionnaire at baseline and 4 months.   "
29042|NCT02905500|"     AVIRON study aims at estimating the burden of various causes of death and morbidity in the     Reunion Island population.   "
29043|NCT02905487|"     ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and     C-reactive protein in obese women and their newborn at delivery whether exposed or not to     Gestational Diabetes Mellitus (GDM)   "
29044|NCT02905474|"     Patients with complex, long-lasting conditions such as chronic kidney disease (CKD) often     take multiple medications and frequently have serious medication problems, arising from poor     communication between doctors and patients. Prescription errors or misunderstandings can     cause harm and lead to emergency room visits or even hospitalizations. To address these     issues, medication reconciliation is now used by hospitals as a way to confirm the medication     list of patients on admission to and discharge from hospital. However, a similar process does     not exist outside the hospital setting. In recent years patients have become more proactive     in undertaking activities with a direct bearing on their health. Such activities may include     maintaining an accurate list of their medications. The rapid growth of the digital health     arena has led to the development of a large number of commercially available mobile     medication management apps for patients. These digital tools are 'stand-alone' products that     are not integrated with the patients' pharmacy or health record system. They rely on patients     to enter the list of their medications and update it as necessary. Moreover, few have a     function to communicate medication changes or problems with their healthcare providers.     Recently, an integrated smartphone, eKidneyCare, app system was developed with a medication     management feature to help patients maintain an accurate mobile medication list. Patients'     current medication information in the pharmacy database is uploaded onto their by a     pharmacist and changes are tracked regularly through a bi-directional communication system.     Updates to the medication list occur seamlessly by the pharmacist, and patients and their     physicians are notified about any medication errors or serious adverse events. This study     will determine whether our eKidneyCare app with its medication management feature will     decrease medication errors and improve patient safety compared to the more traditional way of     managing medications.   "
29045|NCT02905461|"     This randomised controlled trial will establish the effect a contraceptive intervention     delivered by mobile phone text message on the acceptability of effective contraception in     Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4     months (intervention) or a monthly text message not about contraception (control).     Participants will complete a questionnaire at baseline and 4 month follow-up.   "
29046|NCT02905448|"     The effect of a diet free from animal-sourced nutrients on a variety of risk factors for     chronic non-communicable diseases in weight reduction programs is not well established. In     this non-randomised interventional study, the investigators will document the effects of a     low-fat, plant-based diet supplemented with two daily plant-based meal replacements on serum     LDL cholesterol as a primary end-point and total cholesterol, triglycerides, serum fasting     glucose, serum urate, serum insulin-like growth factor 1 (IGF-1) and body fat mass as     secondary end-points. These end-points will be measured at baseline, after 10 weeks and after     30 weeks of intervention. Participants will be enrolled in the interventional arm with     prescribed low fat plant-based diet from the group of all applicants to a free living     population-based diet optimising program. The choice to participate in the study will be made     by participants themselves.      The investigators hypothesise that low-fat plant based diet supplemented with plant-based     meal replacements eaten ad libitum allows a significant reduction of serum LDL cholesterol     concentration.   "
29048|NCT02905422|"     The proposed study aims to combine evidenced based tools and guidance (H.E.A.L.T.H.: Healthy     Eating Activity Lifestyle Training Headquarters) previously tested that has been developed     specifically for use by Army Soldiers and a remote clinical intervention model that includes     mobile tracking technology/devices for physical activity, weight and nutrition. This program     is called the H.E.A.L.T.H. Intensive.   "
29049|NCT02905409|"     The purpose of this study is to determine the effects of two different internal limiting     membrane peeling with distinct diameters on anatomical closure grades after macular surgery     measured by OCT (optical coherence tomography.).   "
29050|NCT02905396|"     Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and     unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as     burning pain in the extremities in combination with autonomic symptoms. So far, the results     of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents     have been developed.      This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined     with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in     patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on     a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or     at least much improved or very much improved, on the Patient Global Impression of Change     (PGIC) for pain and sleep.   "
29051|NCT02905383|"     The aim of this study is to investigate the effect of a multi-component exercise program on     physical function, physical activity and health-related quality of life (HRQOL) in older     people recently discharged from hospital. The intervention consists of 32 group-based     exercise sessions, performed twice a week. In addition the participants in the intervention     group will be encouraged to perform an exercise program on their own, at least once weekly.     The participants in the control group will be encouraged to exercise on their own, according     to the World Health Organization (WHO) recommendations on physical activity for adults aged     65 and above.   "
29052|NCT02905370|"     This research study explores the effects of a progressive, multi-component intervention     following a stay in the hospital or rehabilitation facility. The purpose of this research     study is to compare a multi-component intervention (higher intensity exercise, nutritional     supplementation, and greater emphasis on functionally enhanced care transitions) with usual     care physical therapy.   "
29054|NCT02905344|"     Within the Ear, Nose, and Throat (ENT) medical space, a relatively small number of patients     follow through with elective surgeries to fix ailments like a deviated septum or occluded     sinus passage. Patient understanding of their diagnosis and treatment plan is integral to     compliance, which ultimately yields improved medical outcomes and better quality of life.     Here the investigators report the usage of advanced inkjet 3D printing methods to develop a     multimaterial replica of the patient's nasal sinus anatomy, derived from clinical X-ray     Computed Tomography (CT) data. The final patient education model was developed over several     iterations to optimize material properties, anatomical accuracy and overall display. A two     arm, single center, randomized, prospective study was then performed in which 50 ENT surgical     candidates (and an associated control group, n = 50) were given an explanation of their     anatomy, disease state, and treatment options using the education model as an aid. Each     patient was then surveyed for their self-rated understanding of their anatomy, disease, and     treatment options.   "
29055|NCT02905331|"     The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics,     immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in     participants with moderate to severe plaque-type psoriasis.   "
29056|NCT02905318|"     The purpose of this study is to find out what effects a new drug, palbociclib, has on     prostate cancer and will look at the side effects of treatment with palbociclib. The     researchers doing this study are also interested in looking for markers that may help predict     which patients are most likely to be helped by palbociclib and to see how the cancer cells     respond to palbociclib.   "
29057|NCT02905305|"     In an effort to further preserve residual acoustic hearing after cochlear implantation, it     may be beneficial to incorporate anti-inflammatory agents into the electrode array for     passive elution over a time course after implantation. This study aims to assess the ease and     effectiveness of such an electrode design, and to assess the preliminary safety of use of     such a device in the post-operative period. This study is a first-time-in-human study of the     investigational device.      In the first instance, the aim of the current investigation is to obtain first experience in     use of a Combined Device in the adult clinical population, and to assess tools and techniques     that may be considered in future clinical studies of similar devices.   "
29058|NCT02905292|"     The overall objective of the research is to identify the prevalence and incidence of BPPV and     the impact on balance problems, fall risk and inactivity in frail elderly. The investigators     will demonstrate the importance of early diagnosis and treatment in this patient group.   "
29059|NCT02905279|"     This study tests the effectiveness of exposure therapy for fear of spiders as enhanced by the     use of antagonistic or opposite actions during treatment. The goal of the study is to compare     the efficacy threat-relevant opposite actions and threat-irrelevant opposite actions in     extinguishing fear.   "
29060|NCT02905266|"     This is a safety and efficacy study of different administration regimens of nivolumab plus     Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.   "
29061|NCT02905253|"     The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and     well-tolerated when orally administered at single- and multiple-ascending dose to healthy     adults   "
29062|NCT02905240|"     A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the     efficacy of a single dose of Autologous Protein Solution (APS) in patients with     Osteoarthritis (OA) of the knee.   "
29063|NCT02905227|"     This study is an open-label, parallel group study to evaluate acute pulmonary safety and     Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation     powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.   "
29064|NCT02905214|"     Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex     ISAR Stent for the treatment of real world patients with de-novo and restenotic lesions     after stand-alone angioplasty in coronary arteries.   "
29065|NCT02905201|"     The primary purpose of this study is to determine the rate of compliance to abiraterone     acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic     prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a     real-world clinical setting.   "
29077|NCT02905045|"     hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to     grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions     including measuring uterine depth, inserting the cannula; and injection of the dye   "
29078|NCT02905032|"     The objective of this project is to evaluate a treatment decision aid for patients with     atrial fibrillation.   "
29066|NCT02905188|"     This study enrolls patients who have a type of cancer that arises from the liver called     hepatocellular carcinoma. The cancer has come back, has not gone away after standard     treatment or the patient cannot receive standard treatment. This research study uses special     immune system cells called GLYCAR T cells, a new experimental treatment.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting cancer:     antibodies and T cells. Antibodies are types of proteins that protect the body from     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special     infection-fighting blood cells that can kill other cells, including cells infected with     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with     cancers. They have shown promise, but have not been strong enough to cure most patients.      Investigators have found from previous research that they can put a new gene into T cells     that will make them recognize cancer cells and kill them. In preclinical studies, the     investigators made several genes called a chimeric antigen receptor (CAR), from an antibody     called GC33 that recognizes glypican-3, a protein found on almost all hepatocellular     carcinoma cells (GPC3-CAR). This study will test T cells genetically engineered with a     GPC3-CAR (GLYCAR T cells) in patients with hepatocellular carcinoma.      The GLYCAR T cells are an investigational product not approved by the Food and Drug     Administration.      The purpose of this study is to find the biggest dose of GLYCAR T cells that is safe, to see     how long they last in the body, to learn what the side effects are and to see if the GLYCAR T     cells will help people with GPC3-positive hepatocellular carcinoma.   "
29128|NCT02904369|"     This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral     tablets to assess systemic and genital tract bioavailability in healthy women. The oral     tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300     mg, Truvada). Samples will be obtained before, during and after dosing in two study phases.   "
29129|NCT02904356|"     The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on     brain imaging and neurophysiological measures of cognitive control in patients with     Obsessive-Compulsive Disorder (OCD).   "
29067|NCT02905175|"     Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint     destruction strongly correlated with anti-citrullinated protein antibodies citrullinated     anti-peptide (ACPA). Precise RA etiology remained unclear with a described association     between RA and periodontal disease. The missing link could be a gram-negative anaerobic     bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in     periodontal disease and able to induce gingival citrullinated protein via an enzyme called     peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and     in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in     RA, the investigators will compare its effect on various cell type with comparison with     another oral bacteria Provatella intermedia.   "
29068|NCT02905162|"     To inform the design of a future transitional HIV care intervention for releasees, the study     proposes to prospectively assess clinical outcomes for HIV-infected prisoners after release;     explore factors from health behavior theory that are associated with post-release retention     in care, with a special focus on Alcohol Use Disorders (AUDs); and conduct formative research     to determine releasee and stakeholder knowledge, attitudes, and preferences surrounding     transitional care interventions.   "
29069|NCT02905149|"     The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia     technique ( interfascial block at the serratus muscle) performed in patient undergoing breast     surgery and the effect of this technique on postoperative analgesia.   "
29070|NCT02905136|"     Neurological and psychiatric diseases are one of the major health problems worldwide. Decades     of fundamental and clinical research have led to the model that these disorders results from     synaptic imbalance between excitatory, inhibitory and modulatory systems in key brain     structures. Although the network and neurotransmitter systems involved have been delineated,     the mechanisms leading to improper neurotransmissions remain poorly understood. One major     limitation lays in the difficulty to transpose the identified dysregulation in humans to     relevant animal models in which molecular and cellular targets can be manipulated.      The amino-acid glutamate mediates the vast majority of excitatory neurotransmission in the     mammalian brain. We know that the glutamatergic synapses can change their strength by     regulating surface expression and dynamics of their postsynaptic receptors, through changes     in receptor recycling and/or lateral diffusion. This synaptic plasticity underlies higher     cognitive functions such as learning and memory and is likely compromised in several disease     states. Regulating glutamate receptor number and function is thus of primary importance. New     subcellular imaging technique rendered possible the study of receptor trafficking and     receptor regulation in various conditions including pathological models opening new     fundamental questions. Moreover, recent breakthroughs on glutamate receptor structure offer     unprecedented clues on the molecular and structural mechanisms underpinning receptor     dysfunction at the atomic level.      Recently, description of encephalitis associated with specific autoantibodies (Abs) directed     against neuronal synaptic receptors or proteins (NSA-Abs) opens new lights in the     pathophysiological mechanisms of some human brain disorders. The best example and the most     frequent syndrome is the synaptic autoimmune encephalitis associated with autoantibodies     against extracellular domains of the glutamatergic NMDA receptor (NMDAR-Abs). Classically,     patients first present psychiatric symptoms with hallucinations and bizarre behavior before     development of neurological symptoms such as seizures, dyskinesia, and autonomic instability.     Despite the severity of neuropsychiatric symptoms, more than 80% of patients fully recover     after immunomodulatory treatments and many arguments suggest a direct role of NMDAR-Abs in     the symptoms. The investigators recently demonstrated that NMDAR-Abs directly modify, at the     synaptic level, NMDAR lateral diffusion by disruption of the interaction between NMDAR and     EphrinB2 receptor, a synaptic protein anchoring NMDAR at the synapse (Mikasova et al, Brain     2012; Dupuis et al, EMBOJ 2014). These data suggest that NMDAR-Abs could directly participate     in the neuropsychiatric disorders observed in patients and that NMDAR dysfunctions could be     directly responsible for the observed symptoms. Furthermore, these data suggest that other     NSA-Abs directed against other synaptic proteins could explain specific neurological symptoms     in patients with encephalitis that are not associated with NMDAR-Abs.      The aim of MECANO is to combine multidisciplinary approaches (clinical, immunological, and     neurobiological ones) to identify new NSA-Abs, to characterize their specific pathological     roles and to decipher acute and chronic NMDAR-Abs effects on biophysical and structural     properties of the NMDA receptor, synaptic plasticity, neuronal morphology, and cognitive     performance. This project should provide key insights onto the effects of patients' NSA-Abs     on the cellular dynamic and regulation of synaptic proteins or receptors and on the molecular     cascades activated during synapse dysfunction. The investigators will investigate how NSA-Abs     binding alter receptor activity, modify surface receptor mobility and dynamically regulate     the maturation of synapses and circuitries. For that purpose, The investigators will use a     unique combination of high-resolution imaging (single nanoparticle tracking), receptor     engineering, cellular electrophysiology, computational (structural modeling) and cellular and     molecular biology approaches and finally behaviour assays. Based on both cutting-edge     neurobiology and clinical expertise of autoimmune disorders, and strengthened by promising     preliminary experiments, the MECANO project will likely open new avenues of fundamental     research in the understanding of synaptic dysfunction and clinical research for the treatment     of neuropsychiatric disorders.   "
29071|NCT02905123|"     Amazon's Mechanical Turk (MTurk) is an online platform that has become a popular means of     recruiting participants with problem drinking, gambling, or even illicit drug use for the     purposes of survey-based research. There is also the possibility that potential participants     could be identified through MTurk for online longitudinal studies, including for brief     intervention research. The potential to quickly and easily identify large numbers of     participants through MTurk is important for research evaluating online interventions during     the period that these interventions are being developed and refined. However, before     proposing MTurk workers as a viable source for participants in online intervention trials, it     is important to evaluate the feasibility of using MTurk for such a purpose. This pilot study     proposes to test this feasibility by systematically replicating a trial of an extensively     evaluated brief online intervention for hazardous alcohol use (CheckYourDrinking; CYD) and     will attempt to recruit and follow-up participants for this replication using people     recruited through MTurk.      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants     identified as problem drinkers based on an initial survey will be invited to complete another     survey in 3 months time. Those who are interested will be randomized to receive access to the     Check Your Drinking screener (CYD condition) or to a no additional information condition     (control condition). At three-months post-baseline, the MTurk portal will be used to send     invitation emails that contain a link to the follow-up survey. The primary hypothesis to be     tested is that participants receiving access to the CYD intervention will report a greater     level of reduction in number of drinks in a typical week between the baseline survey and     three-month follow-up as compared to participants in the no information control condition.   "
29072|NCT02905110|"     The goal of this clinical research study is to establish the safety of simultaneous infusions     of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in     patients with recurrent malignant posterior fossa brain tumors. These tumors include     medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant brain tumor     with recurrence or progression involving anywhere in the brain and/or spine. Patients'     disease must have originated in the posterior fossa of the brain.   "
29073|NCT02905097|"     The aim of the study is to assess the performance of the cementless Triathlon Tritanium     tibial baseplate for total knee replacement, with a minimum follow up of 5 years.   "
29074|NCT02905084|"     The environment of the ICU and operating room allows the multi continuous monitoring of     patients in critical situations. The physician anesthesiologist is working more and more in     an environment where he receives a multitude of information from both the patient's medical     history but also measured data in real time to its physiological situation. It is sometimes     difficult for practitioners to consider all of the information by identifying a course of     action. A decision support and a degree of automation can increase security along the lines     of what has been observed in many processes and industries like aviation.      The goal of this project is to establish initially a database of physiological parameters. We     want to use patient data to model physiological processes in order to advance towards the     creation of physios program,   "
30406|NCT02887729|"     Genkyst is a regional cohort involving up to nephrologists working in private and public     nephrology centers in the West of France. It registers clinical and molecular genetic data of     all consenting patients with ADPKD from this area.   "
29079|NCT02905019|"     The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and in     combination with a viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and     MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive     volunteers.      Healthy adult volunteers will be recruited in London, Oxford and Southampton.      All vaccinations will be administered intramuscularly. The study involves having either two,     three or five vaccinations and then undergoing challenge infection with malaria, or receiving     no vaccinations then undergoing challenge infection with malaria.   "
29081|NCT02904993|"     To compare two methods of post-operative pain management in patients undergoing total hip     arthroplasty. There is a perception that the periarticular injections may not be as effective     in controlling post-operative pain.      Both methods are current standard of care. The investigators want to compare the outcomes of     each when patients are randomized to one of the methods compared to the other method of     post-operative pain control.   "
29083|NCT02904967|"     Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a     chronic disease with a recurrence rate of 30% at 10 years.      Reduce the risk of recurrence is a serious public health issue. For this it is necessary to     identify patients at high risk of recurrence. However, until now, only 50% of recurrences are     in the presence of known risk factors, suggesting that there are still yet unidentified risk     factors.      The assumption behind this project is that there are specifically associated genetic     polymorphisms to the risk of VTE recurrence.      The aim of our project is to identify these polymorphisms from genome-wide data MARTHA     cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one     episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for     approximately 500,000 polymorphisms.      The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects     with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the     controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be     compared between cases and controls. The identification of these new genetic variants     associated with VTE recurrence should allow us to improve the pathophysiological knowledge of     the disease, reduce the frequency of episodes and focus research on new therapeutic     approaches.   "
29084|NCT02904954|"     The purpose of this study is to find out the effectiveness of the drug durvalumab (MEDI4736)     with or without stereotactic body radiation therapy (SBRT) as treatment for stage IB and II     non-small cell lung cancer (NSCLC) prior to surgery and one year following surgery.   "
29085|NCT02904941|"     This is a randomised trial that aims to evaluate whether a transient skin cover made out of     human amniotic membranes is effective in managing burns among pediatric patients. The primary     outcome of this trial is the proportion of skin grafted amongst participants. Secondary     outcomes include hospital stay and the number of surgical debridements required by included     patients.   "
29086|NCT02904928|"     With the increasing number of advanced surgical operations being done annually, including the     elderly, the risk of developing postoperative delirium is potentially high. Postoperative     delirium is associated with longer hospital stay, poorer functional outcome, cognitive     decline and an elevated morbidity and mortality, in addition to an increased cost of health     care. However, most of the studies on postoperative delirium have been done in high income     countries, leaving a paucity of literature on the incidence and associated factors of     postoperative delirium in Africa and hence a need to do this study.   "
29087|NCT02904915|"     The purpose of this study is to compare the pain level and level of discomfort with     paracervical block versus no analgesia in women who present to the University of Texas (UT)     Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and     the UT Physicians Women's Center- Bellaire for IUD insertion.   "
29088|NCT02904902|"     This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese     subjects with moderate to severe Hidradenitis Suppurativa (HS).   "
29089|NCT02904889|"     Most older adults want to stay at home for as long as possible. To reach this aim it is     important to maintain their mobility and self-care abilities. However, many older adults are     at risk to lose their abilities, as they have an inactive lifestyle. In this study, homecare     professionals learn to motivate their clients to be more active in daily and physical     activities. Examples of these activities are washing and dressing, household chores or going     for a walk.      The primary aim of this exploratory study is to evaluate the implementation of the 'Stay     Active at Home' program (process evaluation). The secondary aim is to get insight into the     potential effectiveness of the program with regard to several primary and secondary outcomes     measures (effect evaluation). The tertiary aim is to test the feasibility of the proposed     study design.   "
29090|NCT02904876|"     Through this phase IV study, multicenter prospective exploratory, uncontrolled, the     investigators propose to identify MRI predictive factors of treatment response, using     diffusion MRI sequences, in addition to conventional sequences.      The primary objective is to study the links between changes on MRI diffusion and response to     treatment with Tysabri to 2 years.      The secondary objective is to compare the evolution of diffusion MRI data with the volumetric     MRI data.   "
29091|NCT02904863|"     The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting     both children and adults. HUS is characterized by the abnormal occurrence of diffuse     thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting     especially the kidneys and is associated with hemolytic anemia. One of the major problems     encountered in the management of HUS is the absence of reliable marker of treatment response     or relapse; conventional hematological markers being too insensitive to judge therapeutic     efficacy or identify early relapse. Data from the literature suggest that the endothelial     cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial     activation plays a critical role in the initiation and / or relapse of the disease.The main     objective of this study is to define a vascular competence profile in a population of     patients with typical or atypical HUS; both in the acute phase and in remission of the     disease.   "
29092|NCT02904850|"     Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a     pharmacokinetic (PK) has been prepared using data from the literature. This model must be     validated at concentrations achieved in practice. This is a preliminary study before the     implementation of a randomized trial confirming the therapeutic monitoring of erlotinib     through this model.   "
29093|NCT02904837|"     Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of     the most injurious to the independence in daily living activities and the quality of life of     people living with Parkinson's disease (PPD). Despite a considerable amount of research,     there is no consensus about the most efficient physiotherapeutic approach to improve gait     disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor     performance of healthy individuals and people with stroke. However, there is little evidence     about its therapeutic results as a tool to improve gait performance in PPD. Thus, the aim of     this study is to investigate the effects of mental gait practice associated with physical     practice (PP) to improve the gait performance of PPD.   "
29163|NCT02903914|"     This study is an open-label Phase 1 evaluation of CB-1158 as a single agent and in     combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.   "
29094|NCT02904824|"     This is the first Development Safety Update Report prepared for Phase I-IIA Clinical Trial-     FIBHGM-ECNC007-2010 (PHASE I / IIA CLINICAL TRIAL, UNICENTRIC, RANDOMIZED, CONTROLLED, TWO     PARALLEL-GROUPS, TO EVALUATE THE SAFETY OF A NEW THERAPY WITH STEM CELLS DERIVED FROM ADIPOSE     TISSUE FOR GLOTTAL GAP(GG) IN THE UNILATERAL PARALYSIS OF THE VOCAL CORD(VC) ) in the     International Conference on Harmonization (ICH). Patients are randomized to receive one of     the following therapeutic strategies:      Group A: Autologous Fat processed by centrifugation to fill a paralyzed vocal cord. Group B:     Autologous Fat enriched with stem cells from adipose tissue to treat vocal cord paralysis.      Active control: Autologous fat tissue processed by centrifugation. Route of administration:     Injection into a paralyzed vocal cord.      Experimental drug: Stem cells from autologous adipose tissue in which autologous tissue is     enriched or in suspension to fill the paralyzed vocal cord. The aim is to induce the     overexpression and production of microvessels at local level. Route of administration:     injection into the thickness of a paralyzed vocal cord.   "
29095|NCT02904811|"     The main objective of the study is to determine whether early screening and treating young     women (<25 years of age) for genital Chlamydia Trachomatis (Ct) infection reduces the     cumulative incidence of pelvic inflammatory disease (PID) over 24 months.      As secondary objectives, the study aims        -  To determine the baseline prevalence and the incidence of Ct infection;        -  To improve knowledge on natural history of Ct infection in young women such as the rate          and timing of progression to PID (at the beginning of the infection, at the end,          throughout the course of infection), as well as the incidence of reinfections with Ct;        -  To investigate the relation between host immuno-genetic factors and the clearance,          persistence and development of late complications (PID) as an explanation for the          inter-individual heterogeneity in the susceptibility to and course of Ct infection.   "
29096|NCT02904798|"     Polypodium Leucotomos Extract (PLE) is a tropical fern that has antioxidative,     photoprotective, chemoprotective, anti-inflammatory, and immunomodulatory properties. The     antioxidative effects of PL include inhibition and scavenging of free radicals, lipid     peroxidation and reactive oxygen species (ROS) such hydrogen peroxide, superoxide anion,     hydroxyl radical and singlet oxygen. Visible light (400-700 nm) causes pigmentation in     melanocompetent individuals and induces DNA damage in the human skin through ROS production.     The goal of this study is to determine whether the administration of oral PLE has an effect     on the development of visible light induced pigmentation.   "
29097|NCT02904785|"     The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy     reduces knee pain and enhance function in patients with primary knee osteoarthritis.   "
29098|NCT02904772|"     The aim of the study is to provide further confirmatory evidence of clinical benefit in LPLD     patients treated with alipogene tiparvovec by assessing both the clinical response (as     defined by a range of parameters), and the metabolic response (postprandial CM metabolism)     in LPLD patients with and without an immunosuppressant regimen.   "
29099|NCT02904759|"     The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for     the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of     treatment.   "
29100|NCT02904746|"     This study will evaluate the preliminary effectiveness of Make It!, a single 15-minute     intervention aimed at increasing attendance to a follow-up appointment for psychological     services (i.e., an information class) among clients accessing walk-in services at a mental     health crisis response centre. As a secondary aim, we will examine the demographic     correlates, presenting problems, and symptom correlates of clients who do and do not attend     follow-up services.   "
29101|NCT02904733|"     A large (3900 patients) cohort study, undertaken in five European sites to validate in a     mHealth platform to enable self-management of HIV in patients with stable disease using a     tailored HTA process, Model for Assessment of Telemedicine Applications (MAST), specifically     developed for the assessment of mHealth solutions.      As site recruitment will be sequential and the recruitment period will last 18 months, a     maximum follow-up of 35 Months will be undertaken. Study visits will take place at baseline     defined as the time of mHealth introduction, months 6, 12, 18, 24 and 30.   "
29102|NCT02904720|"     The purpose of this study is to determine the prevalence of vitamin D deficiency among the     population of pregnant women receiving prenatal care and giving birth at the investigators'     clinic. The further purposes are to identify the population at risk for vitamin D deficiency     and to analyse whether vitamin D deficiency is associated with pregnancy complications.   "
29110|NCT02904616|"     The Institut has developed a spectrofluorimeter for the registration and monitoring of skin     autofluorescence.      This Spectrofluorometer must be initially validated in healthy volunteers. In the long term,     it will be used clinically to measure residual photosensitivity of patients who received a     photosensitizer in photodynamic therapy.   "
29111|NCT02904603|"     Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis     C infection. In this study cytokine markers will be measured during therapy up to time point     SVR 12 an correlated to clinical Parameters and regular laboratory findings.   "
29112|NCT02904590|"     The purpose of this study is to determine the incidence and risk factors related to Infection     in patients with Inflammatory Bowel Disease (IBD)   "
29113|NCT02904577|"     Prospective collection of data of possible prognostic relevance in patients with indolent non     - follicular B-CELL Lymphomas.   "
30407|NCT02887716|"     The objective of this study is to describe the change in the percentage of fat in the lumbar     spine.   "
29103|NCT02904707|"     Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks,     between the knee and foot, and with no tendency to spontaneous healing.      In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general     population and 3% in subjects over 65 years.      The sex ratio is generally 3 females to 1 male. It is in most cases a complication of     vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and     microcirculatory.      In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions     (sleep disorders, eating, work stoppages) and major economic (individual and collective costs     of absorptions).      The treatment of a chronic wound uses validated techniques for several years as the skin     graft in tablets, associated with the etiological treatment.      The latest recommendations HAS implemented to date from 2006 and concerns the management of     leg ulcers predominantly venous.      Few articles in the literature address the possibility of an analgesic effect of the     transplant pellets in the treatment of chronic ulcers algic.      In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg     ulcer patients and feet and showed that there was a reduction in pain post transplant.      We propose to evaluate the analgesic effect of the skin graft in pellet on a patient     population having one or more Algic ulcers.   "
29125|NCT02904421|"     The study aimed to:        1. To investigate and compare the changes in bone mineral density (BMD), trabecular bone          micro-architecture, bone strength, and curve severity at a mean of 6 years longitudinal          follow up in AIS girls with low bone mass between Group A and B:             1. Group A: subjects followed at a mean of 4 years after completion of 2-year calcium               and Vit-D supplementation and             2. Group B: subjects without calcium and Vit-D supplementation        2. To evaluate the correlation between changes in BMD, trabecular bone micro-architecture,          and bone strength documented in Objective 1 with changes in serum bone turnover markers   "
29104|NCT02904694|"     A national database is being set-up to collate clinical outcome information before and after     children undergo Selective Dorsal Rhizotomy (SDR). SDR is a surgical procedure that has been     used for many years but has not been routinely available within the United Kingdom National     Health Service (NHS). The SDR procedure is used to improve spasticity in children with     cerebral palsy and involves dividing some of the nerve fibres running from the muscles back     to the spinal cord. While it is believed that SDR is effective, there are no definitive data.     In July 2014 NHS England commissioned five NHS Trusts to undertake SDR surgery in eligible     children for a two-year period, and to collect detailed information on their outcomes. The     proposed database will aggregate these data from the five centres and analyse them to provide     overall evidence on the clinical effectiveness of SDR. This information will be used to     inform future commissioning decisions. The database has been developed by the King's     Technology Evaluation Centre (KiTEC) in conjunction with NHS England and the national     clinical SDR steering committee and its data subcommittee. KiTEC undertakes research     evaluations for the National Institute for Health and Care Excellence (NICE), and has been     commissioned by NICE to undertake this work. Clinicians in the SDR data subgroup have liaised     closely with KiTEC to agree which data to collect so that it the least amount needed and will     be in a standardised format across all centres. When all two-year outcome data are recorded,     KiTEC will analyse the data and present a report to NHS England, NICE and the SDR steering     committee and data sub-group. While there are no firm plans to follow the children beyond two     years post-surgery, all parties involved are hoping that further funding can be obtained to     continue following these children up as these data will be unique.   "
29105|NCT02904681|"     Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired     vertebral structure occurring in children and adolescents with involvement of the growth     cartilage causing impaired growth and kyphosis.      There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical     expressions; the most important being kyphosis with spinal stiffness associated with painful     elements.      The radiographic definition according Sorenson is uniformisation 5 ° affecting at least three     adjacent vertebrae.      Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain     which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover     disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally,     scalability because the curvature may increase the likelihood of degenerative lesions disc     degeneration or lumbar spinal stenosis for example.      When the disease is diagnosed early, treatment is most often associated with orthopedic     physiotherapy. However, for patients with active deformation, despite an orthopedic brace     treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical decision     can be taken.      The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes     through a spinal fusion must be released from his column stiffness in a bad position,     changing the equilibrium profile and ensure that it remains in a good position.      This surgery usually requires a prior operative time (thoracic surgery to remove the     intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with     a bone graft and osteosynthesis). Currently different surgical strategies are practiced there     is no real consensus between the teams.   "
29106|NCT02904668|"     Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck     movements or sustained neck postures. The onset and course of this pain is influenced by     environmental and personal factors.Many studies report that participants preferred self-care     measures for the management of neck pain and they sought professional help only when those     measures fail   "
29107|NCT02904655|"     The study is a randomized, crossover meal-replacement pilot intervention to determine     feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for the     impact of a healthy diet on asthma outcomes. Participants with doctor-diagnosed asthma were     randomized to crossover trial of a 4-week dietary intervention or usual diet with a 4-week     washout period. During the dietary intervention, all meals and snacks were provided by the     study.   "
29108|NCT02904642|"     The overall objective is to test the impact of short message service (SMS) reminders, with or     without unconditionally provided mobile-money incentives, can improve measles vaccination     coverage in rural western Kenyan infants.   "
29109|NCT02904629|"     The objective of this research study is to evaluate a culturally tailored sexual and     reproductive health intervention among American Indian (AI) youth. Specifically, the     investigators aim to evaluate the impact of Respecting the Circle of Life: Mind, Body and     Spirit on knowledge, attitude and behavioral outcomes associated with risk for unprotected     sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized     controlled trial on the White Mountain Apache (WMA) reservation. The investigators will     examine whether the RCL intervention effectively reduces risky sexual behavior among AI     adolescents (11-19 years old), with long term goals of reducing teen pregnancy and     incidence/prevalence of STIs. The evaluation will focus on well-established intermediate     outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI     incidence.   "
29114|NCT02904564|"     The purpose of this study is to determine whether 5-FU infusion (Microinfusion of Medicine     Percutaneously - MMP) is effective for Idiopathic Guttate Hypomelanosis (IGH) repigmentation     compared to conventional Microneedling. MMP is a procedure done with tattoo devices using     medication in place of ink.   "
29115|NCT02904551|"     This prospective controlled randomized blind clinical study investigated 44 implants     displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral     prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG,     gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were     assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline,     were assessed at 18 months.   "
29185|NCT02903628|"     The purpose of this study is to determine whether Eye Health Intervention can obviously     reduce and delay myopia onset and development and improved the awareness rate of knowledge     apparently .   "
29117|NCT02904525|"     Despite maximal safe surgery followed by combined chemo-radiation therapy, the outcome of     patients suffering from glioblastoma (GBM) remains extremely poor with a median survival of     15 months. Hence, new avenues have to be taken to improve outcome in this devastating     disease. Given their intracerebral localization and their highly invasive features, GBM pose     some specific challenges for the development of adequate tumor models. Orthotopic xenograft     models directly derived from the tumor of a patient might represent an attractive perspective     to develop patient-specific targeted therapies. This approach remains however to be validated     for GBM as it offers specific challenges, including the demonstration that the properties of     xenograft models validly represent treatment relevant features of the respective human     tumors.      In this innovative project the investigators aim to compare and validate an approach of     paired human GBM and respective derived orthotopic xenografts in the mouse brain on the     levels of radiological behavior and metabolism of the tumors, as determined by high     resolution MRI of the patients (7T MRI) and the respective orthotopic mouse xenografts (14.1T     MRI), as well as on the level of the transcriptome, genome, and methylome of the original GBM     tissue and respective derived xenografts/glioma sphere lines. The data will be integrated in     multidimensional analyses and interrogated for similarities and associations with molecular     GBM subtype.      This pilot project will provide the basis for the crucial next steps, which will include drug     intervention studies. New promising drugs, tested pre-clinically in the mouse orthotopic     xenograft models established here using the radiologic/metabolic/molecular procedures     described for this project, will be taken into patients in phase 0 studies. GBM patients will     receive radiologic/metabolic follow-up using high resolution MRI under drug treatment,     followed by resection of the tumor and subsequent acquisition of molecular data.   "
29118|NCT02904512|"     Several observational studies have shown that uncontrolled hyperglycemia in hospitalized     patients in the non-critical care, non-Intensive Care Unit (non-ICU) setting is associated     with prolonged length of stay, increased mortality and an increased incidence of infections.     Randomized clinical trials in both the critical and the non-ICU settings have shown that by     improving glucose control there is a decrease in the incidence of infections, length of stay     and inpatient health care costs.      Continuous glucose monitoring (CGM) systems have evolved as useful devices providing     excellent clinical care in patients with Diabetes Mellitus (DM). These systems detect glucose     in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements     to a receiving device that reads out average glucose levels every couple of minutes.      In this clinical trial the investigators propose to examine the clinical use of CGM in     hospitalized patients with Diabetes Mellitus type 2 (DM2). CGM use may improve glucometric     values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 (DM2).      We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring     devices that are in the nursing station. Half of the participants are placed on Real Time CGM     (alarms turned on) and half of them are placed on blinded CGM values (alarms turned off).     Nursing staff will be notified when glucose is <85 mg/dl , in order to treat and potentially     prevent a potential hypoglycemic episode.   "
29119|NCT02904499|"     Public health surveillance models, previously used for the ongoing detection of occurrence of     rare events, could be used to reinforce existing pharmacovigilance systems. These models have     not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative     databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran,     launched recently on the French market for atrial fibrillation (AF). This drug is at high     risk for severe ADR and requires thus careful pharmacovigilance monitoring.      Primary objective is to compare the results of ongoing surveillance models to detect     hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results     obtained from the analysis of a cohort of patients with AF under the same treatment.   "
29120|NCT02904486|"     The purpose of this study is to Effectiveness of Modified Health Belief Model Based     Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students.   "
29121|NCT02904473|"     This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of     the GROWell diet intervention. The objective of this study is to determine whether the     GROWell intervention can help transition women from consuming a Western diet to consuming a     prudent diet (characterized by consumption of primarily fruits, vegetables, healthy fats,     lean proteins, and whole grains) during pregnancy. Efficacy will be measured as change in     dietary components, using a Food Frequency Questionnaire (FFQ) at baseline and at a follow up     visit at 37 weeks gestation.      The GROWell intervention is a mobile health technology that uses interactive text messaging     and dietician coaching calls, and may be effective in transitioning pregnant women from a     Western to a prudent diet during an approximately 6 month intervention period. GROWell     results will be measured against an Attention Support Control (ASC) arm, where participants     will receive messaging that is pregnancy rather than diet focused, and a Usual Care (USC)     arm, where participants will not receive text messages or study coaching.      Results from this study will be used to support a grant submission for a larger study, aiming     to investigate the GROWell intervention and prudent diet consumption as preventatives against     postpartum depression.   "
29122|NCT02904460|"     The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a     light and cooperative sedation as soon as possible in order to decrease the period of     mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the     referential hypnotic in this case with a reduction of the morphine-type use.      DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study     is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for     adults, to describe the receivers of DEX and to report the procedure of this new molecule.   "
29140|NCT02904213|"     An open label, non-comparative bridging study to evaluate the safety of pentavalent vaccine     ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a     3-dose series, interval for each dose is 4 weeks   "
29123|NCT02904447|"     The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th     toes and the metatarsal distal caput in patients who have had surgery with a partial proximal     hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.      Also, to examine these variables and compare them to the totalt range of motion and pain, to     find out if the measured pedobar pressure can be used identify the well treated patient and     the poorly treated patient.      The pedobar pressure gradients will be compared with a control group with healthy feet.   "
29124|NCT02904434|"     Voriconazole has better response rates, improved survival and less adverse side effects     compared to other drugs for the treatment of invasive fungal infections making it a desirable     therapeutic option for children. However, dosing is unpredictable in children and this leads     to therapeutic failure. This study aims to understand the physiological differences between     children and adults that leads to therapeutic failure of voriconazole in children.   "
29126|NCT02904408|"     The aim of this study is to determine the benefits of group psychotherapy on quality of life     for people with hidradenitis suppurativa receiving medical and surgical treatment versus a     control group (awaiting group) treated with medical and surgical treatment, without     psychotherapy.   "
29130|NCT02904343|"     An important reason for the costs of hemodialysis treatment in China are expensive is the     hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the     basis equipment of the hemodialysis treatment. After years of research and development, China     has had the domestic hemodialysis machine. However, due to the lack of control studies of     domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine     promotion has been hindered. The aim of this study is to verify the quality and safety of     domestic hemodialysis machine.   "
29131|NCT02904330|"     This study is the first time that K1-70 will be administered to humans. The principal aim of     this study is to obtain safety and tolerability data when K1-70 is administered as an IM     injection to subjects with Graves' disease.      Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction     of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium     antagonists may be used to control some of the symptoms of hyperthyroidism.      K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo     diagnostic and therapeutic tools for the management of patients with Graves' disease,     patients with thyroid cancer and patients who would benefit from controlling receptor     activity.   "
29132|NCT02904317|"     Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an     off-label use of oral misoprostol (OM).      Design: Pair-matched case-control study.      Setting: Tertiary-care academic centre in Germany.      Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction.      Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a     consecutive series of 69 women was compared with induction using oral misoprostol in a     pair-matched cohort.      Main outcome measures: The primary outcomes were the time from induction to delivery and the     caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal     scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.   "
29133|NCT02904304|"     National clinical trial, phase III, multicenter, randomized, prospective, double-blind,     parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged     equal or more than 18 years will be randomly allocated to one the drug group or placebo     group.   "
29134|NCT02904291|"     Bariatric surgery changes the anatomy of the gastro-intestinal tract. Little is yet known     about how the patients' new physiology may alter the pharmacokinetics of medication. Changes     in biological availability of medication may have implications for the patients' health in     the years following surgery.   "
29135|NCT02904278|"     The purpose of this study is to collect and compare information on how and when adolescent     heart transplant recipients take their prescribed medication. The investigators want to find     out if regular use of 'an app' on cell phones, called the Teen Pocket PATH (TPP), can help     adolescents take their medication according to their prescribed dosing schedule. This may     then help reduce complications of transplant, such as rejection. The investigators also want     to find out if how adolescent heart transplant recipients take their medications affects the     development of antibodies in their blood. Antibodies are small proteins in the blood that may     develop after heart transplantation, and which can sometimes damage a new heart.   "
29136|NCT02904265|"     The purpose of this study is to compare the effectiveness of the medications acetazolamide     and diazepam in the treatment of continuous spike wave in sleep (CSWS) and Landau-Kleffner     syndrome (LKS).   "
29137|NCT02904252|"     The primary objective is to assess the prevalence and genotypes of HCV infection in     thalassemia major and thalassemia intermediate patients who have received blood transfusion     in the Department of Medicine, Faculty of Medicine Siriraj Hospital.      The secondary objective is to identify the effect of HCV infection as well as the risk     factors of advanced liver disease and liver cirrhosis in these patients      The third objective is to identify the role of serum HA level and fibrotest in the prediction     of cirrhosis in these patients.   "
29138|NCT02904239|"     New technical developments make ultra-fast non-electrocardiogram (ECG) triggered scan     acquisition with a high temporal resolution possible, which can be used for the evaluation of     cardiac pathologies on a standard thoracic Computed Tomography (CT) scans.      Current studies have shown that it is possible to assess the heart and it's coronary arteries     on standard ultra-high pitch thoracic CT, which could result in incidental or new cardiac     findings. However, to be able to perform a complete cardiopulmonary assessment on a thoracic     CT scan, the injection protocol and bolus tracking settings could be optimised for both     aortic and pulmonary vasculature (e.g. sufficient attenuation in pulmonary arteries,     pulmonary trunk and ascending aorta).      Therefore, the aim of the study is to evaluate the presence and extent of coronary artery     disease, valvular morphology and calcification, pericardial abnormalities, and cardiac size     on a standard ultra-high pitch thoracic CT-scan with individualised injection protocols.   "
29139|NCT02904226|"     JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of     JTX-2011 alone or in combination with a fixed dose of nivolumab in subjects with advanced     solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose     (RP2D), as well as to evaluate preliminary efficacy.   "
29141|NCT02904200|"     The primary objective of this investigation is to evaluate changes on Peri-Wound skin from     baseline to termination when using two different wound dressings      The secondary objectives are to evaluate:      •pain before and during and after dressing removal from baseline to termination   "
29142|NCT02904187|"     The primary objective to this study is to describe bilateral auditory information processing     in profoundly deaf patients with bilateral cochlear implants compared with normal hearing     patients. Assumption used is that due to the central consequences of bilateral deafness on     binaural auditory information central processing, time between activation of the two cochlear     implants is a decisive factor in bilateral implantation compared to unilateral implantation   "
29143|NCT02904174|"     Malnutrition, risk of falls and medication incidents are commonly faced by the older adults.     This study aimed to provide health education to community-dwelling older adults and to assess     the effectiveness of a Healthy Living Program (HLP) to older adults in terms of fall     prevention, drug management and healthy eating habits.   "
29144|NCT02904161|"     To address the challenges of isolating and analyzing rare cells, this study aims to validate     technical diagnostic instrumentation, tests, protocols and analysis to correlate the number     of circulating tumor cells present in whole blood for predicting cancer prognosis and     treatment efficacy. Investigators propose to enroll and follow cohorts of cancer patients.     Blood samples will be collected from these patients at regular intervals as determined by     their doctors. The patient's disease progression will be monitored over the lifetime of this     study. The specific aims are to isolate, enumerate and analyze the number of circulating     tumor cells (CTCs) in patient blood using chip-based sorting, filtration and imaging     techniques. Investigators will also use this study to optimize diagnostic instrumentation,     test protocols and downstream CTC analysis. Investigators may also correlate the results of     these tests with the prognosis of the patients as well as any clinical evidence (e.g. from     radiological imaging scans). While investigators focus on prognosis in this study, these     correlated tests potentially may also be valuable in future studies for early diagnosis and     monitoring of cancer.   "
29145|NCT02904148|"     Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these     complications is shoulder pain which affects about 35 to 70% of cases. The medical care of     this complication is critical because it affects the patient's quality of life and also     hinders participation in rehabilitation sessions slowing the recovery of independence in     activities of daily living.      Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his     attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce     shoulder pain.      Because no data available to permit us to determine the sample size we set-up this     preliminary study to check if efficiency found in these preliminary data are consistent with     an estimable real efficacy in a randomized trial feasible.   "
29146|NCT02904135|"     To address the challenges of isolating and analyzing rare cells, this study aims to validate     the instrumentation, the test protocols, and the analysis of patient's outcome to show the     instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In     order to facilitate the validation process, investigators will only focus on metastatic     patients for whom CTCs supposedly present at higher abundance. Investigators propose to     enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from     these patients before they start any new line of therapy as determined by their doctors. The     specific aims are to isolate, enumerate and analyze the number and/or molecular information     of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging,     and molecular profiling techniques. Investigators will use this study to optimize diagnostic     instrumentation, test blood processing protocols and CTC analysis algorithm. During this     study investigators will collect patients' clinical information related to cancer, as well as     the patients' survival status to validate the system's prognosis ability.   "
29147|NCT02904122|"     In this study we want to compare a dental diagnose during face to face consultation vs remote     consultation with telemedicine device.   "
29148|NCT02904109|"     The purpose of this study is to investigate the effects of the eNOS activating agent     triflusal on episodic memory and cognitive functions in participants under chronic stress.   "
29149|NCT02904096|"     The primary objective of this study is to evaluate the safety of Radiesse implantation for     very severe volume loss in the dorsum of the hand at 6 months after treatment.   "
29150|NCT02904083|"     Bipolar disorders are common psychiatric disorders characterized by severe and recurrent     symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods     characterized by persistent residual symptoms, impaired functioning and quality of life. In     addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and     a high frequency of somatic comorbidities. Poor adherence is one of the major factors     influencing the course of the disorder and one of the causes of ineffective treatments.     Considering that between 20 and 60% of patients with bipolar disorder have problems with     adherence. Adherence is modulated by a number of socio-demographic, clinical and     neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition,     studies have shown that the reasons attributed to poor adherence are different depending on     whether questioning patients or healthcare professionals. This fault diagnosis, assessment of     the causes and fit into the reasons associated with poor adherence is an aggravating factor     of the problem. However, this factor seems modifiable by better training of professionals. A     team from Newcastle University in England has developed a training program for all health     professionals to improve the diagnosis and understanding of compliance issues in bipolar     patients and provide simple tools to fight against patients with this problem. The     investigators assume that this training will improve medication adherence among outpatients     by trained professionals.   "
29203|NCT02903394|"     The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI)     endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will     obtain optical measurements from the cervix. These measurements can be used to create a map     of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and     the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most     likely to occur.   "
30414|NCT02887625|"     To compare efficacy, safety and durability of combination therapy with pioglitazone plus     GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus     sulfonylurea   "
29151|NCT02904070|"     Prematurity is the leading cause of mortality and perinatal morbidity. Despite the many     preventive measures and use of tocolytic therapy, the incidence of premature births has not     decreased in recent decades. In 2010 the preterm birth rate (single child, born alive) was     still 5.5% in France and 11% in the population of Reunion. In 50% of cases, premature birth     is related to spontaneous premature labor layout without rupture of amniotic membranes,     called threat of premature birth.The threat of premature birth, defined by the combination of     cervical modifications and regular and painful uterine contractions from 22 weeks of     amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in     pathological pregnancies services. But all threat of premature delivery situations do not     cause premature delivery. In our service, only 30% of patients hospitalized for threat of     premature delivery give birth prematurely in accordance with published international data.     The diagnosis of threat of premature delivery is difficult and it is still not possible to     differentiate a false labour of a real labour.      Currently the diagnosis of threat of premature delivery in routine is based on the     combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks     specificity.      In absence of prognostic tool for predicting more reliably the risk of premature delivery in     situation of threat of premature delivery, the medical cares are maximalist.:     hospitalization, conducting paraclinical investigations, prescription of tocolytics     treatments and conducting antenatal corticotherapy. it seems particularly necessary to     identify more efficient prognostic criteria that the clinic and ultrasound for judging the     severity of threat of premature delivery in other words to predict the risk of premature     delivery to adapt and adjust the care of patients after diagnosis of threat of premature     delivery.   "
29152|NCT02904057|"     This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS)     to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and     contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated     with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and     FACE-Q instrument   "
29153|NCT02904044|"     TsColEPS aims at identifying individual determinants of sport injuries during physical     activity lessons in secondary school at reunion Island.   "
29154|NCT02904031|"     -  Few data are available about the treatment of metastatic colorectal cancer (mCRC)          elderly patients with anti-EGFR agents in combination with chemotherapy. Up today, most          of the available data are from retrospective/post-hoc analyses, making them difficult to          translate to everyday clinical practice.        -  FOLFOX plus panitumumab is a standard first-line therapy option for RAS wild-type          untreated mCRC patients. Slight adjustments in chemo-dosage are commonly applied in          routinary practice to elderly patients, but those modified schedules have never been          prospectively tested.        -  In elderly patients, a reasonable upfront treatment is a fluoropyrimidine-based          monotherapy plus bevacizumab, irrespectively of the molecular status of RAS.        -  BRAF mutation is a strong negative prognostic factor associated to advanced age, poor          performance status (PS), extended and aggressive disease and is associated to a lack of          benefit from anti-EGFR moAb.        -  Clinical definition of elderly (over 70 years old) CRC patients that may deserve a more          or less intensive combination therapy is still debated. The cut-off of 75 years old          combined with ECOG PS assessment is a reasonable approach for clearly defining          candidates to different approaches31.        -  Several geriatric screening tools have been used to identify patients with a geriatric          profile potentially predicting for overall survival and risk of toxicity. The G8          screening tool has been validated in cancer patients showing the strongest prognostic          value for overall survival; the CRASH score is able to stratify patients according an          estimated risk of treatment-related toxicities.      On the basis of these considerations, the investigators designed the present randomized phase     II trial of first-line therapy panitumumab in combination with simplified FOLFOX or with     5-fluorouracil, in previously untreated elderly patients with RAS and BRAF wild-type     unresectable mCRC.   "
29155|NCT02904018|"     In this study we want to evaluate the oral care pathway after an oral teleconsultation.   "
29156|NCT02904005|"     This study aims at identifying predictors of suicidal behaviors in depressed subjects.     Investigators will first compare demographic, clinical, and biological features of depressed     recent suicide attempters (within one week) and depressed subjects without lifetime history     of suicide attempt. Baseline risk factors for suicide will be used to predict the risk of     attempting suicide during a one year follow-up. A thorough evaluation of these patients will     allow to identify the factors associated with suicidal risk and develop a simplified risk     score that could be used in clinical settings to improve our practice.   "
29157|NCT02903992|"     The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to     various negative health outcomes such as impairment of physical performance and disability.     Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the     frailty syndrome. However, for clinical use and for treatment and prevention strategies,     reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are     indispensable.      This topic has recently been addressed by the Foundation for the National Institutes of     Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below     which older adults had a higher likelihood of clinically relevant weakness reflected by low     grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (<0.789 men and <0.512     women) was found to be associated with increased likelihood for mobility impairment.      In this context, the aim of this study is to study the prevalence of sarcopenia in a sample     of community-dwelling frail and pre-frail older adults.   "
29158|NCT02903979|"     In front of a lack of evidence to determine the best treatment for deep cavitated carious     lesions, the search for an effective restorative technique, which results in a least possible     discomfort to patients, and reduce the time needed for the restorative treatment, if becomes     relevant. The objective of this randomized clinical trial to evaluate the efficacy of high     viscosity glass ionomer cement restorations (HVGIC) compared to indirect pulp capping with     calcium hydroxide cement associated with high viscosity glass ionomer cement (HVGIC) for     treatment of deep lesions in primary molars, as well as the impact of treatment on quality of     life, cost of procedures, the perception of parents / carers, patients and operators, and     satisfaction with the techniques evaluated. Children with 4 to 8 years will be selected     randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 166 teeth will     be randomized into two groups: (1) indirect pulp capping performed with calcium hydroxide     cement, followed by restoration with HVGIC and (2) HVGIC restoration. The restorations will     be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments.     The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria     related to the effectiveness of the restorative treatment with HVGIC compared to indirect     pulp capping with calcium hydroxide cement, (2) criteria focused on the patient, (3)     cost-effectiveness, (4) perception of parents and operators about the treatments. For     comparison between the two groups will be used the Kaplan-Meier survival and the long-rank     test. Cox regression is performed the assessment of the influence of some other variable     results. For all analyzes, the significance level is set at 5%.   "
29204|NCT02903381|"     This research study is evaluating a new drug called nivolumab as a possible treatment for     smoldering multiple myeloma in order to prevent or postpone development of active multiple     myeloma.      - Patients with smoldering multiple myeloma do not have symptoms but are at risk for     progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell,     which is an important part of the immune system. Patients with active multiple myeloma     generally require treatment.   "
29159|NCT02903966|"     This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1)     kinase inhibitor, in subjects with active ulcerative colitis (UC).      The primary objective will be to investigate the safety and tolerability of repeat oral doses     of GSK2982772 60 mg or placebo twice daily for 42 days (Part A) followed by open label with     GSK298772 60 mg twice daily for 42 days (Part B). In addition to pharmacokinetics (PK), a     number of experimental and clinical endpoints will be employed to obtain information on the     pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no     formal hypothesis will be tested, these endpoints will enable a broader understanding of the     mechanism of action and potential for clinical efficacy of GSK2982772 in UC.      Within 30 Days of screening visit, subjects will be randomized to receive either GSK2982772     60 mg or placebo orally twice daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study.     Subjects who complete the Part A study will move to open label Part B study to receive     GSK2982772 60 mg twice daily for an additional 42 Days (6 weeks). After the open label (Part     B) treatment period, subject will enter the Follow-up period which lasts for 28 Days (+/- 3     Days) post the last administration of study medication. The total duration of participation     in the study will be approximately 20 Weeks from screening to the last study visit.   "
29160|NCT02903953|"     The very most part of clinical research in France takes place in teaching hospitals.     Advantages to develop it in others hospitals are numerous: access to innovative treatments,     improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and     reduced selection bias. The objectives of the study are to report the current situation of     clinical research outside of teaching hospitals in France.   "
29161|NCT02903940|"     The purpose of this study is to evaluate the application of Negative Atrioventricular     Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT)     patients.   "
29162|NCT02903927|"     The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601     PY for the monocular uncorrected distance visual acuity and compare it to the reference     monofocal IOL Acrysof IQ SN60WF.   "
29164|NCT02903901|"     To test the efficacy of melatonin compared to placebo in preventing post-operative delirium     and reduction in intensity or duration of delirium in individuals 65 years of age and older     who undergo orthopedic surgery after low energy lower extremity fractures (LELEF).      Biomarkers may play important roles in the detection, prediction and management of delirium     especially in frail elderly individuals. Predictive biomarkers may help characterize an     individual's susceptibility to delirium and thereby help specialized treatment, care and     management of such individuals during their hospitalization. They may also help predict     treatment response to a specific modality and help in selection of such modality. Recent     studies performed in the UK and published in 2011 have measured plasma cholinesterase     activity and determined that these levels were lower in patients who developed delirium     compared with remaining subjects. Other studies have indicated that CRP may also have a role     in delirium prediction as they have found that CRP measured on admission to an ICU had     predictable changes that occurred within 24 hours that in turn were predictors of delirium.     One the aims of the study is to compare the predictive and treatment response values of     groups of biomarkers that have been hypothesized to be of predictive value.   "
29165|NCT02903888|"     A cross-sectional, observational multicenter study to assess the reasons for choosing the     3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study     will be conducted in standard clinical practice conditions at public and private gynecology     clinics and during a single study visit.      Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD     as their contraceptive method will be included in the study.   "
29166|NCT02903875|"     The therapeutic education of patients and their close relations is, as yet, poorly developed     in France in the field of oncology, in particular for cancers of the upper aerodigestive     tract. In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with     radiotherapy remains a reference treatment for advanced stage cancers. This mutilating     surgical procedure has a major impact on the patient's life, due to its physical and     functional sequelae. Its psychosocial consequences are also important, owing to the     biographical disruption and the identity-related metamorphoses associated with illness and     its treatment, which alter the quality of life not only of patients, but also of their close     relations. Currently, care for laryngectomised patients consists essentially in informing and     educating them on certain technical procedures during hospital admission. New voice education     can be a long process and often involves the intervention of a speech therapist, who serves     as the link between the patient and the hospital care team. These healthcare modalities often     insufficiently account for the social, environmental and personal factors that interact in     health-related problems.      The aim is to design, implement and evaluate a patient therapeutic education (PTE) programme,     for laryngectomised patients and their close relations, aimed at improving their quality of     life.      The research will be conducted over three phases:      The first phase, referred to as the pilot phase, will include exploratory, observational     and retrospective analysis aimed at developing knowledge on the consequences of laryngectomy     on the quality of life of patients and their close relations, the strengths and weaknesses of     current practice in patient support and the needs expressed by the players involved     (patients, relations, professional carers). This analysis will be conducted via interviews     with patients and their close relations and focus groups with the healthcare professionals     involved in patient care and support (hospital and independent). This first phase will enable     the pluridisciplinary design of a therapeutic education programme for laryngectomised     patients and their close relations which will be tested in the study's principle coordinating     centre. The method defined thus is in keeping with quality criteria set by the HAS specifying     that the PTE should focus on the patient, be scientifically justified, and be developed by a     pluridisciplinary group reuniting representatives of patients or patient associations.      The second phase, referred to as the prospective intervention replication phase, aims at     evaluating the programme's transferability and quality in three centres. The centres     participating in this second phase already have experience in the development of PTE     programmes and will be involved in the workgroup entrusted with the design of the PETAL     programme during phase 1.      The third phase, referred to as the randomised multicentric comparative intervention phase,     should enable us to assess the benefits of the developed PTE programme on the quality of life     of patients and their close relations.      This is a pluridisciplinary study via which we hope to improve the quality of life of     laryngectomised patients and their close relations through the design and the sustainable     deployment of an innovative PTE programme in France and Belgium. This project also aims at     reinforcing town-hospital links to improve help, follow-up and support for patients and their     close relations, as well as dialogue between healthcare professionals.   "
29167|NCT02903862|"     The purposes of this study are to (1) track dementia caregiver health indicators over 12     weeks, both with and without the Mindoula plus DANA intervention (case manager and mobile     messaging and assessment applications) to determine if the intervention improves caregiver     health and (2) obtain feedback from caregivers to inform on the design of future     interventions.   "
29168|NCT02903849|"     The investigators are interested in using personalized, self-motivating messages to motivate     people to exercise more.   "
29169|NCT02903836|"     Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral     Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial     Pneumonia (CABP) in Adults   "
29170|NCT02903823|"     The goal of this pilot study to determine whether there is a significant therapeutic     advantage to place the ITB catheter within the cervical, thoracic or lumbar region of the     spine. It is also a goal of this pilot study to determine whether the origin of spasticity     influences the effect of Lioresal Intrathecal (baclofen injection) on ITB catheters located     in the cervical, thoracic or lumbar regions of the spine. The investigators propose to study     the impact of catheter location on the reduction in spasticity within a group of patients who     are scheduled for ITB trial.   "
29171|NCT02903810|"     Clinical study of CD19 CAR-T in the treatment of blood and lymphatic system tumor has been     achieved a breakthrough. The main solution in clinical research is to use CD19 CAR-T infusion     alone. Because of the heterogeneity of the tumor, the patient often carries tumor cells with     CD19 deficient but other positive target antigens (such as CD22). Specifically removal of     CD19 positive tumor cells in CAR-T treatment, CD19 negative tumor cells or tumor cells which     carry other target antigens would amplify with extra free space released at the same time,     resulting in the relapse of tumors of heterogeneities. In order to effectively control the     recurrence, CAR-T treatment scheme specific for several target antigens was presented and     verified. However treatment with the sequential infusion of different target specific CAR-T     cells, the window period between two times infusions may be the opportunity for the tumor     recurrence of heterogeneity; and bispecific CAR-T has also been reported only one CAR can be     fully functioned. In order to avoid these problems, this topic puts forward for the first     time in the international with a treatment scheme of an equal amount of infusion of CD19-41BB     and CD22-41BB two Car-T in the treatment of refractory hematologic malignancies. We expect     the treatment is more effective in eliminating tumor burden, and also can inhibit the     recurrence of tumor heterogeneity at the same time.   "
29172|NCT02903797|"     The purpose of the study is to determine serum irisin hormone levels an its relation between     endometrial hyperplasia   "
29173|NCT02903784|"     According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly     progressive, infiltrating the central nervous system, mainly affecting young adults.      This surgery should nevertheless be conducted in awake condition to achieve two conflicting     goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of     functional structures. So awake after opening the skull, the patient undergoes a series of     preoperative tests, administered by a speech therapist present in the operating room. This     procedure allows the neurosurgeon to establish an individual functional brain mapping in real     time, through the observation by the SLP of the patient's answers to direct electrical     stimulation applied to the cortical and sub-cortical. This support is based on the     extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive     lesion. To ensure the patient the highest achievable load should increase our understanding     of brain function, including the neural bases of language, glioma grade 2 is predominantly     localized functional area of language.   "
29174|NCT02903771|"     The main purpose of this study is to determine the safety and feasibility of weekly     intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian     cancer, Fallopian tube cancer or primary peritoneal cancer. The study also aims to determine     the maximum tolerated dose of Cantrixil in these patients when administered as a monotherapy     or a combination therapy.   "
29175|NCT02903758|"     Malaria is still endemic in the interior of French Guiana. mixed infections by 2 or more     different malaria parasites lead to complex and potentially harmfull therapeutic problems.     The aim of the study was to look at malaria smears between 2000 and 2008 and determine using     PCR the frequency of mixed infections, and their distribution in the terrtory of French     Guiana. Overall 10.75% of 400 smears showed mixed infection with P. falciparum and P. vivax.     The Maroni river where Duffy negative populations live was largely devoid of vivax     infections. These results suggest that mixed infections are frequent in french guiana except     on the Maroni river which leads to practical implications for clinicians facing a patient     with clinical malaria.   "
29176|NCT02903745|"     French Guiana is the French territory where the prevalence of HIV is highest. in order to     determine the knowledge attitudes, beliefs, and practices among the target group of teenagers     attending the public school system a survey was conducted in 2011. schools and classrooms     were randomly selected, and a structured questionnaire was administered. Descriptive     statistics were obtained and multivariate logistic regression was used to determine     predictors of main outcomes such as age at first sex.      the results will be used to guide prevention of HIV and sexually transmitted infections     though the school system.   "
29177|NCT02903732|"     The objective of the autism registry is to estimate the prevalence of autism in French Guiana     in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence     of comorbidities, and to determine the theoretical and actual orientation of these children     regarding care and education in a territory with significant structural deficits relative to     mainland France. The outcomes of this registry will be to guide decision makers in their     funding priorities to improve, screening, diagnosis, care and education for children on the     autistic spectrum   "
29178|NCT02903719|"     The aim of this study is to explore whether the use of ultrasound guided phrenic nerve block     can reduce the postoperative pain in the shoulder after liver resection. The intervention is     directed postoperative to the patients experiencing novel right sided shoulder pain.   "
29179|NCT02903706|"     Malaria is the most widespread parasitic illness in the world, and it is endemic to Guiana.     Although the number of cases has decreased since 2005, sources of infection still remain,     particularly within illegal gold mines. These malaria carriers/sufferers often use     self-medication to deal with malaria symptoms, resulting in a risk of resistance to     anti-malarial treatments, and particularly to artemisinine. The mobility of this population     across the Guiana Shield increases both the risk of malaria spreading and the resistance of     this illness to treatment in the region, and puts the population at risk of new outbreaks of     this disease despite the great efforts put into anti-malarial policy in this region.      Fighting malaria within this population is therefore a dual public health challenge: on the     one hand, make it possible for the WHO to eliminate malaria from the Guiana Shield by 2017,     on the other to limit resistance to artemisinine in this region. However, Guiana's particular     context - namely the illegal status of gold mines and the difficult geographical access, the     Harpie military operations, the illegality of carrying out malarial diagnosis tests and     treating cases without the presence of a health professional - prevents us from achieving     this goal using the same tools as our neighbours in Suriname, whose  Looking for Gold,     Finding Malaria  programme was a success.      A better understanding of the malarial epidemiology in this population will enable us to     propose innovative, more adapted measures to combat malaria within these guyanese     populations. This is an transversal, multicentric observational study.   "
29180|NCT02903693|"     Given that cervical cancer is the second most frequent cancer among women in french guiana     the aim of the study was to determine the screening rate among women living in French Guiana.     Cervical smears are read in 2 laboratories which allowed us to compute screening rates per     100 women-years. overall the screening activity was 23.5-25.8 smears per 100 women-years.     between 2006 and 2011 54% of women were screened. These baseline figures will allow to     evaluate present efforts to increase the screening rate for this frequent cancer in French     Guiana.   "
29200|NCT02903433|"     Avocados are an excellent source of fiber, potassium, magnesium, and poly- and     mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns     and have the potential to improve the cardiovascular disease (CVD) risk profiles of families     in the United States (US). The proposed research plan will focus on the contribution of     avocado intake to the reduction in CVD risk of US families, by examining the effects of     avocado intake on the overall nutritional status of families. Of particular interest is     establishing these effects in ethnic populations such as Hispanics/Latinos. On average,     Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This     6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine     the impact of avocados on the overall dietary pattern of their families. Future research will     extend the results of the current trial to a larger sample of ethnically diverse families in     order to evaluate whether sustained changes occur in nutritional, cardiovascular and     metabolic health status.   "
29181|NCT02903680|"     Background: Headaches is one of the most common complaints of children in the ED and the     treatment of pediatric migraine is largely based on extrapolation data from adult studies,     limited pediatric trials, clinical experience and expert consensus. Despite the fact that     dexamethasone has already been proven effective to reduce recurrence and is currently used in     treating adults with migraine, no studies have looked at its use in the treatment of     childhood migraine where relapse rate of about 50% are described in the 48h following     successful treatment in the ED.      Objective: To examine the effectiveness of parenteral dexamethasone at preventing migraine     recurrence in children and to study the risk factors for migraine relapse after discharge     from the ED.      Methods: This a randomised, double-blind, placebo-controlled clinical trial among all     children 8 to 17 years of age with a presumptive diagnosis of acute migraine and treated with     a standardized protocol in the ED of the CHU Ste-Justine, a tertiary care pediatric hospital.     After the parenteral administration of prochlorperazine or metoclopramide and     diphenhydramine, the patients were randomised to receive either dexamethasone or a placebo.     They were excluded from the intervention if they had a known allergy or absolute     contraindications to receiving parenteral corticosteroids, if they were already on a     corticosteroid regimen or if they did not respond to the initial abortive migraine therapy.     All included patients were discharged on a 48-hour course of naproxen and with a headache     diary to fill out and return. The primary outcome was the incidence of relapse in the 24-48h     following discharge from ED. The secondary outcomes evaluated were the mean level of pain,     the use of rescue medication after ED discharge, the return rate to the ED or the visit to a     health care professional within 7 days including hospitalisation. The associated symptoms,     the adverse events after parenteral corticosteroids and the risk factors for migraine relapse     were also evaluated. A telephone follow-up was made to ensure the headache diary was     completed and returned.   "
29182|NCT02903667|"     An open, prospective, randomized, multicenter study focused on the ridge diminution in case     of grafting of fresh extraction sockets with Bio-Oss Collagen, Bio-Gide (Geistlich Pharma,     Wolhusen, Switzerland), placing Dentsply implants (Astra Tech System).   "
29183|NCT02903654|"     Given the high incidence of Pompe's Disease in French Guiana (100 times higher than in     mainland France) the aim is to determine the prevalence of heterozygotes among women having     just delivered in French Guiana who accepted that their newborn child enters the depipomp1     study. In these women the specific mutations p.Gly648Ser and p.Arg854X will be sought using     PCR in order to calculate the prevalence of these mutations and estimate the risk factors     associated with them in order to improve genetic counselling.   "
29184|NCT02903641|"     Malnutrition accounts for nearly half of child deaths worldwide. Children who are     well-nourished are better able to learn in school, grow into more physically capable adults,     and require less health care during childhood and adulthood. Moreover, it is difficult to     make up for poor childhood nutrition later in life. I present here the proposal for an     intervention that builds on a larger study in Ethiopia and will generate insights into the     importance of behavioral factors related to persistent malnutrition in low-income settings,     allowing for more targeted, cost-effective interventions in the future.      Existing data from the study region, Oromia, Ethiopia, suggest that many mothers know how to     correctly respond to a hypothetical situation where a young child exhibits poor growth. On     the other hand, however, mothers frequently appear unaware about their own children's growth     deficiencies. Together, these facts suggest that false beliefs about the appropriateness of a     child's physical size are a more likely contributor to malnutrition, rather than a weak     understanding of how to help a malnourished child.      The proposed intervention will provide evidence on the relationship between caregiver beliefs     about child nutritional status and the caregiver's behavior, ultimately analyzing how this     relationship influences important nutritional choices for young children in a setting with     limited resources. The study uses a two-by-two randomized trial; the first treatment is a     cash transfer labeled for child food consumption, and the second is the provision of     personalized information about the quality of the child's height compared to other children     like those of the same age and gender in East Africa. Together the two treatment arms will     provide evidence about the relative importance of behavioral versus resource barriers to     improved nutrition. Better understanding of the interaction between these key factors is     essential in addressing one of the foremost health issues facing developing countries today.   "
29186|NCT02903615|"     Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the     beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency,     whereby blood glucose levels rise and diabetes develops. When there is severe insulin     deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin     replacement therapy; dietary intervention is a also cornerstone of glucose management.      The Optimise Diet is a multi-pronged diet based on best health principles: to minimise     blood glucose rises after eating, reduce the immune cells involved in destruction of the     insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In     this study, its effects will be compared to the Standard Diabetes Diet that is currently     recommended in Australia and internationally.   "
29187|NCT02903602|"     The purpose of this study is to determine the effectiveness of an innovative methodology for     training Community Health Workers that will improve their effectiveness in educating mothers     to adopt best practice health behaviors in the home.   "
29188|NCT02903589|"     The HIV epidemic flared from 0 to over 1% prevalence in a decade on the Maroni river which     lies between French Guiana and Surinameaim of the study is to determine the knowledge,     attitudes, behaviours, and practices on HIV in the population living along the French bank of     the Maroni border. Descriptive statistics are computed from the tabulation of answers to a     structured questionnaire. Multivariate logistic models were computed to determine predictors     of key outcomes. These data will help taylor prevention intervention in this very particular     area.   "
29189|NCT02903576|"     This study is a Phase I/II , open label,non randomized, prospective study to determine the     safety of human embryonic stem cell derived Retinal pigmented epithelium (hESC RPE) sub     retinal injections versus hESC RPE seeded on a polymeric substrate implanted in the sub     retinal space,   "
29190|NCT02903563|"     The aim was to determine the knowledge attitudes, beliefs, and practices regarding HIV in a     population of sex workers in French Guiana and in the Brazilian border town of Oiapoque. A     standardized questionnaire was administered face to face to sex workers. Analysis of the     questionnaires led to descriptive statistics. Multiple logistic regression models were     computed to determine the predictors of condom use.   "
29201|NCT02903420|"     A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the     safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model:     9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis,     who are determined by the heart team to be unable to undergo safe open surgical therapy and     have the benefits of the study valve implantation.   "
29202|NCT02903407|"     This study aims to examine the use of protocol directed sedation using the Duke PAD protocol     with the current sedation medications of propofol or dexmedetomidine compared to the PAD     protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial     step toward understanding the best management of sedation in these patients.   "
29205|NCT02903368|"     This research study is studying a combination of drugs called abiraterone acetate and     Apalutamide as a possible treatment for new diagnosed Prostate Cancer.      The following interventions will be use in this study :        -  Abiraterone Acetate        -  Prednisone        -  Apalutamide        -  Leuprolide Acetate   "
29191|NCT02903550|"     Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl     arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution     consists in a destruction of the ossicles as well as their possible spread through the base     of the skull into the brain. Surgical treatment is required to prevent infectious or     functional complications. A recurrence after surgery occurs in approximately 10% of patients     and rarely affects initial site. Surgical treatment is the only care option for recurrent     cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are     seen. Temporal bone CT is performed prior to surgery for added information on bone erosions     especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high     anatomical resolution and complex anatomy, temporal bone CT is usually displayed with     Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance .      Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients. Since     2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic resonance     imaging (MRI) (sequences has shown high accuracy to depict recurrent cholesteatoma. If EPI     sequences had a high rate of diffeomorphic atefacts whereas non EPI sequences using either     HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or Fast-spin-echo demonstrates     less magnetic susceptibility artifacts. Multimodality fusion between NonEPI-DWI-MRI and     computerized tomography (CT) is a rational promising tool to rise the performance for     cholesteatomas delineation. The performances of NonEPI-DWI-MRI in assessing lesion spread and     volume are still unknown and needs further investigations. The aim of the study is to assess     the DWI-MRI/CT fusion feasibility, reproducibility and the accuracy prior to surgery     propectively compared to surgical findings.   "
29192|NCT02903537|"     The purpose of this study is to determine the safety and tolerability of the intranodal     administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and     pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the most     appropriate regime for the development of future therapeutic trials.      To evaluate the preliminary proof of concept by clinical and/or radiological activity and     immunological markers.   "
29193|NCT02903524|"     Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus     Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in     Locally Advanced Breast Cancer Patients   "
29194|NCT02903511|"     This study is being done to determine if treatment with metformin, a drug widely used for the     treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal     Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly     decreased kidney function. The study will also evaluate the effects of metformin on kidney     growth and kidney function.   "
29195|NCT02903498|"     The purpose of this study is to evaluate the efficacy and tolerability of the maintenance     treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced     gastric cancer.   "
29196|NCT02903485|"     This study aims to demonstrate that presurgical assessement of patients' risk factors and     surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's     care, concerning the rate of complications in cataract surgery with topical anesthesia.      The nurse performs the triage of patients based on a chart of risk factors assessment. The     triage, according to the presence or not of risk factors, leads to patients' care by an     anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for     surveillance during surgery) or to patients' pre-surgical assessement and surveillance during     surgery both performed only by nurses.      In the control group, all patients are taken care of by an aesthetic team, with medical pre     surgical assessement and surveillance during surgery both performed by anesthetic nurses.   "
29219|NCT02903186|"     The goals of this multi-site clinical trial are to pilot test weekly SMS sent to     parents/caregivers of infants to improve feeding practices and decrease excessive weight gain     in infants who are participants of the Women, Infants and Children (WIC) program in Puerto     Rico and Hawaii. The intervention consists of weekly SMS for 4 months to reinforce the     feeding messages provided by WIC.   "
29220|NCT02903173|"     The purpose of this study is to evaluate the breathing patterns of women who undergo cesarean     delivery with spinal or epidural morphine for post-operative pain control in the first day     after surgery. Some women who undergo cesarean delivery may be at risk for respiratory     complications related to opiate administration for post-operative pain. The primary aim of     this study is to evaluate post-operative minute ventilation in women who undergo cesarean     delivery using a novel method of non-invasive minute ventilation monitoring, and to see if     there are predictive risk factors that may predispose women to post-operative     hypoventilation.   "
29197|NCT02903472|"     Changes in the GI microbiota and/or metabolomics have been linked to evolving transformations     in immune system function and infection rates in experimental SCI in animal models. A recent     study involving chronic survivors of SCI show distinct GI microbiome changes in comparison to     healthy controls. GI microbial metabolism of dietary components has been causally linked to     various health conditions, such as cardiovascular disease, infections, which is an ongoing     concern for chronic SCI survivors. It is probable that alterations of GI microbiota are     established acutely after SCI and could subsequently alter medical care and impact health     outcomes for people living with SCI.      This project is a pilot study to describe any changes in the GI and urinary tract microbiota     as they appear over the first year after SCI. When available, data on factors, other than     SCI, that may impact change in the gut microbiome after SCI will also be noted, including:        -  the level and severity of SCI,        -  the time since SCI,        -  the person's immune profile,        -  the antibiotic regimen of the individual and time since antibiotic administration,        -  the incidence and type of infections after SCI and        -  the person's diet or activities after SCI   "
29198|NCT02903459|"     The aim of this study is analyze the relationship between the density of visceral and     subcutaneous fat and cellulite with the lumbar lordosis degree.   "
29199|NCT02903446|"     Bone erosions are a common manifestation and feature of structural damage in severe/chronic     tophaceous gout. Management of this destructive and often debilitating gout complication has     focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but     little attention has been given to prevention or reversal of gout related bone erosions and     other structural damage to bone caused by gout. Since there is no known effective treatment     to attenuate or improve structural damage caused by gout, we propose a pilot, controlled,     proof-of-concept study in which denosumab, an FDA approved medication for the treatment of     bone loss, will be added to standard ULT in 20 patients with erosive gout.   "
29214|NCT02903251|"     This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence     in adults admitted for detoxification of alcohol, and during the following 4 weeks in an     outpatient setting. Half of the participants will receive oxytocin nasal spray, the other     half placebo nasal spray.   "
29206|NCT02903355|"     This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical     trial of oral D-methionine (D-met) to reduce noise-induced hearing loss (NIHL) and tinnitus.     The goal of the study is to develop a safe, oral pharmacological agent to augment physical     hearing protectors for noise exposures that exceed the protective capabilities of ear plugs     and/or muffs. The study population is a cohort of Drill Sergeant (DS) instructor trainees     during and 22 days after their 11 day weapons training. The primary objective of this study     is to determine the efficacy of D-met in preventing NIHL or reducing tinnitus secondary to a     minimum of 500 rounds of M-16 weapons training occurring over an 11 day period.   "
29207|NCT02903342|"     To assess the suitability and user-friendliness of an information leaflet for parents on     management of fever and febrile illness in children. The purpose of the leaflet is to provide     evidence-based information for parents regarding fever and febrile illness in children.   "
29221|NCT02903160|"     The purpose of this study is to determine the clinical benefits of using a rapidly cycling,     non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the     management of castration resistant prostate cancer. The hypothesis is that the identification     of optimal combinations and sequencing of therapies can help prevent or delay the development     of therapeutic drug resistance, and can be safely tolerated.   "
29222|NCT02903147|"     The objective of the study is to examine the effectiveness of a functional-meta-cognitive     intervention program to reduce driving risk factors amongst professional bus drivers.   "
29208|NCT02903329|"     Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting     approximately 63 million people worldwide. MOH is a potentially treatable condition, and     there are different opinions among headache specialists concerning the correct treatment     strategy.      The study is a prospective longitudinal open-label randomized controlled study comparing two     detoxification programs conducted in a tertiary headache care center. Patients with MOH are     either randomized to treatment in program A or program B. In program A, patients undergo     detoxification without any acute medication during a two months period (complete stop of     acute medication intake). In program B, patients was allowed to take up to 2 days a week with     analgesics or migraine medication during the two months detoxification period (restricted     acute medication intake). Both A and B are out-patient programs, and patients in both groups     receive patient education, consisting of six lessons, managed by specialized headache nurses     in collaboration with specialized psychologists and physiotherapists (Figure 1). All patients     are also offered rescue medication (levomepromazine or promethazine) and antiemetics, if     necessary.      The need for prophylactic treatment is evaluated individually after 2-month detoxification.     Patients are followed-up at 2, 6 and 12 months after detoxification. All patients are asked     to continuously register headache calendar and to fulfill questionnaires at all the follow-up     visits. In addition they are asked to fill out questionnaires (Headache Under-Response to     Treatment (HURT), Hospital Anxiety and Depression Score (HADS), Severity of Dependence Score     (SDS), World Health Organization Quality of Life Score(WHO QoL) and Dolo-score) at baseline,     2, 6 and 12 months   "
29209|NCT02903316|"     The purpose of this study is to determine if extra systoles can be used to predict fluid     responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft     (CABG) surgery. As an additional study we will investigate the ability of a mini fluid     challenge to predict response of a larger volume of fluid.   "
29210|NCT02903303|"     This pilot study consists in testing the efficacy of hypnosis as an adjuvant treatment for     patients suffering from chronic lumbar pain and for whom a facet block is indicated by a     doctor in the Centre d'antalgie of CHUV (Centre Hospitalier Universitaire Vaudois), where     this study will take place. 5 to 8 patients will be included in this study. The goals of this     study are :        -  Assess the feasibility of such a protocol with more patients        -  Measure the number of patients necessary to obtain a significant result        -  Search for possible side effects of the combination of both treatments      Every patient in this pilot study will undergo 4 hypnosis sessions within 2 weeks before the     facet block. These sessions will be done with an hypnotherapist formed for this kind of     treatment.      Three times during this study, each patient will have a discussion with the co-investigator     :¨        -  1st discussion : just before the first hypnosis session        -  2nd discussion : after the 4 hypnosis sessions and just before the facet block,          approximately 3 to 4 weeks after the 1st discussion        -  3rd discussion : 2 to 4 weeks after the facet block      They will allow to obtain several data :        -  Pain assessment : intensity, localization, variability, characteristics, effects on          daily life activities        -  Anxiety and depression assessment        -  Expectations assessment : about both treatments and their combination        -  Efficacy assessment : about both treatments for the patient        -  Questions about the perceptions of the treatments (prejudice, ...) et possible side          effects.      These data will then be analysed (quantitative and qualitative analysis, depending on the     question type) to fulfill the objectives of the study.      will include 5 to 8 people suffering from chronic lumbar pain. The procedure consists in two     steps :        1. 4 hypnosis sessions as an adjuvant treatment for number 2        2. a facet block, which is the standard procedure in the Centre d'antalgie in CHUV.      There will be no control group, so every patient will participate to the hypnosis sessions     and undergo the facet block. All the procedure of the facet block (including     contraindications and side effects) are not considered to be part of this study because all     patients in this study would have had a facet block if they would not participate in it.      The only data that will be collected are questionnaires about several items (pain, anxiety,     depression, ...). These questionnaires are filled with the patient at the beginning of the     study (day 0), before the facet block (between day 14 and day 21) and 2-4 weeks after it     (between day 28 and day 49). There are quantitative and qualitative questions.   "
29211|NCT02903290|"     Genetic cerebellar ataxias involves progressive degeneration of the cerebellum. Their overall     prevalence is estimated at 2-4 cases per 100 000 people. These diseases are manifested by a     static and kinetic cerebellar syndrome characterized by impaired balance, coordination, and     an ataxic gait. To date, no therapy is available for patients and physical therapy is     essential and recommended. The evolution of the pathology causes a degradation of walking,     increased instability and risk of falling. In one year, between 74% and 93% of patients     reported having fallen at least once. Falls prevention by understanding the mechanisms     affecting stability is a major issue in the management of these patients physiotherapy. The     analysis of the literature, we assume that there exists a trio fatigue - instability -     energy expenditure in which the three parameters would influence each other. To date, we do     not have data to characterize these interrelationships and their evolution over time.      STUDY OBJECTIVES: The main objective is to study the relationship between changes in energy     expenditure and changes in instability when walking at one year in patients with cerebellar     ataxia gene. The secondary objectives are to study, after one year of development, the     relationship between fatigue, instability, energy consumption, the number of falls, the     severity of ataxia and quality of life.      CONDUCT OF THE STUDY: This is a pilot, multicenter, interventional. The projected duration of     patient recruitment will be 12 months and the total number of patients will be included in     15. The duration of participation in this study is 12 months for each patient. The     anticipated duration of the study is 30 months. Development of the study: Patients included     will perform two sets (S1 and S2) tests a year apart including the evaluation of ataxia     according Scale for the assessment and rating of ataxia (SARA); measuring the quality of life     through SF36 (The Short Form (36)) Questionnaire; quantifying the severity of fatigue     perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before     and after physical activity; quantified analysis of walking on walking track GAITRite® (with     score calculation FAP and GVI) before and after physical activity; physical activity like     walking on a treadmill (with measurement of maximal voluntary quadriceps by manual     dynamometer before and after physical activity to ensure the induction of fatigue). Patients     will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED, Rome,     Italy) during walking analyzes GAITRite®.   "
29212|NCT02903277|"     The median age of onset of chronic myeloid leukemia (CML) in chronic phase PC is about 60     years. However CML affects all age groups including 18-25 year olds, called adult-young     adolescents (AJA). In France, there is no record of CML and especially not for this     particular population, only a European Register of CML in children up to 18 years has been     set up under the coordination of Professor Frederic Millot, pediatrics, CHU Poitiers.     Malignancies diagnosed in this population usually have characteristics, evolution,     therapeutic strategies with tyrosine kinase inhibitors (TKIs) are a real therapeutic     revolution with an overall survival very significantly augmented but at present only a     minority of patients may one day consider a final judgment of treatment. AJA are the most     exposed patients to the complications, the socio-economic repercussions, professional and     personal of a very long-term treatment. But there is little data in the literature concerning     this population. Two studies show that diagnosis of CML presents with poor prognostic factors     (high skoal), the observed responses are poorer compared to older patients but it is     accompanied difference in survival in all cases with a decline of about 70 mois. However,     these studies have focused solely on the patients included in the study receiving optimized     treatment is not the standard treatment at the time. It is clearly demonstrated that the     inclusion in a study brings a benefit to the patient. However, the majority of AJA are not     included in a study. The investigators therefore want to describe the AYA population of CML     in France and compare the evolution of patients included or not in a protocol. The     investigators also want to investigate specific issues of the age of these patients as the     reproductive desire. Indeed, while it does not seem to be any risk of teratogenicity for men     treated with ITK, this risk is clearly established for women and requires specific supported.     Another important point is that of the quality of life. The state of physical and mental     health and his feelings, physical activity and its limitations and well-being was assessed by     the SF-3612 questionnaire. The results of this analysis were compared with those already     obtained for the general population (not representative of Italian adults with cancer sample)     and adjusted for sex, age, geographic region, marital status and education level . There     seems to be young people and women who express a feeling more pejorative. This does not only     covers the frequency of side effects but also on physical activity and well-being. the     affected population will be noted that that is particularly involved in the social,     professional and in the development of his personal life. The impact of treatment on quality     of life must be considered under penalty of seeing the difficulties of compliance. But     several studies have demonstrated the negative impact of poor adherence in response to     treatments .   "
29213|NCT02903264|"     This study evaluated the periodontal condition of gestational diabetes mellitus (GDM)     patients and a healthy non-pregnant control group. For the GDM group all medical data were     recorded, including obesity/insulin resistance indicators.   "
29216|NCT02903225|"     Controlled exercise training is a valuable therapeutic addition to pharmacological treatment     in most patients with chronic heart failure, reducing long-term mortality, preventing cardiac     remodeling and improving functional capacity. Despite the mechanism underlying its benefits     might be multifactorial, a sustained improvement in autonomic balance is usually attributed     as a major effect. Nevertheless, not all eligible subjects show the same response to     exercise, probably due to several differences in the subpopulations enrolled. The     investigators hypothesize that some Heart Rate Variability indexes could be valid tools to     optimize the selection and follow-up of chronic heart failure patients to training   "
29217|NCT02903212|"     The aim of the study is to determine the tolerance of apoptotic autologous cells injection in     subjects with active rheumatoid arthritis.   "
29218|NCT02903199|"     The current study will investigate the effect if whey protein on postprandial glycaemia and     appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control     (leptin, PYY3-36) hormone responses.   "
29223|NCT02903134|"     This study seeks a better understanding of the pathogenesis of asthma in early life. The aim     of this project is to determine whether the offspring of obese mothers at 3 years of life     have increased the risk of asthma compared to children whose mothers were not obese and     whether this increased risk is associated with a programming altered immune reactivity at     birth.   "
29224|NCT02903121|"     The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective     method of preventing pregnancy, but it has bleeding side effects that make it unappealing for     many women. The only study to demonstrate a sustained reduction in bleeding lasting for two     months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the     levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary     data of tamoxifen and ENG implant users, the investigators plan to perform additional studies     on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.   "
29225|NCT02903108|"     The purpose of the present study was to evaluate the effects of subgingival delivery of boric     acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP) patients.   "
29226|NCT02903095|"     Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of TD-1439 in healthy subjects   "
29227|NCT02903082|"     Sepsis remains a major cause of death in developed countries. A better understanding of the     mechanisms involved in the regulation of inflammatory and immune response of patients with     severe sepsis is an important step that could open the way for new therapeutic approaches.   "
29228|NCT02903069|"     This study is for newly diagnosed WHO Grade IV malignant glioma patients to determine whether     an investigational drug known as marizomib (MRZ) will improve the treatment of newly     diagnosed glioblastoma patients by delaying the growth of the cancer, reducing the size of     the tumor, and/or improving survival.   "
29229|NCT02903056|"     Introduction: Rett Syndrome is a neurodevelopmental disease that primarily affects girls.     Clinically, patients are normal before six months to one and half years old, and then develop     progressive severe problems with communication, learning, co-ordination and neurodevelopment,     with loss of motor skills around the age of two. At the same time, stereotyped hand movement     typically appears. However, some of them will improve the abilities in speech and eye gaze,     and the repetitive hand movements may decrease after few years.      Background / hypothesis：Preliminary evidence suggests that there are many differences in     brain structure between Rett syndrome and normal people including cerebral volume reduction     in both white matter and gray matter, cerebral blood flow in the frontal area, and density of     receptors in basal ganglia. In MR imaging studies, decreases in parietal lobe gray matter     were found, and several reductions in cortical white matter were observed by DTI. However,     the visual related pathway- posterior corona radiata in Rett syndrome girls was normal to be     increased in FA values. The similar result was also discovered in the superior longitudinal     fasciculus, associated with speech, which equal to control subjects and patients with     preserved speech (phrases and sentences).Despite this, few studies mentioned comparison with     brain microstructure in the different stage, especially in adult patients. Therefore, our     prospective study will be planned to figure out the specific changing pattern of brain     structure in different stages of Rett syndrome. And the trajectory of microstructure in brain     is going to be in accordance with the functional improvement.      The investigators suppose that (1)there are different microstructural changes for patients     with/without preserved mobility, verbal ability and communication skill; (2)there are a few     specific brain microstructures changes in visual pathway; (3) there is a specific changing     pattern of brain microstructure in different aging of Rett syndrome. To acquire more specific     results, the investigators aim to apply conventional MRI, diffusion-spectrum imaging, and     some clinical assessment tools like Rett syndrome -related questionnaire, SSI, PDMS-2 and     six-minute walk test to investigate their correlation.   "
29230|NCT02903043|"     Limb muscle dysfunction, characterized by loss of capillaries, is amongst the most     troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to     poor functional status and premature mortality.      One prevailing hypothesis stipulates that modification in the expression of miR-204 leads to     change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared     to controls.   "
29231|NCT02903030|"     The physical and mental/emotional health of people with autism spectrum disorder (ASD) are     closely connected. The emerging data on immune abnormalities and gut microbiome differences,     and interactions of the genome with these suggest a possible etiological link between     physical and mental dysfunction, especially the gastrointestinal (GI) dysfunction and severe     anxiety that many individuals with ASD manifest. The investigators have preliminary clinical     evidence that children with ASD & GI symptoms differ in microbiome composition and function     from neurotypical children with GI symptoms. The investigators hypothesize that altered     host-microbial signals, which include altered fecal neurotransmitter gamma-aminobutyric acid     (GABA) levels contribute towards anxiety and sensory over-responsivity in ASD. Our     preliminary findings also show that probiotic Visbiome Extra Strength, improves GI and pain     symptoms, correlating with altered gut microbiome composition and related metabolites (the     macrobiome). The proposed crossover trial will explore the possibilities of this new     appreciation of the microbiome-mental/physical function connection for ASD, GI dysfunction,     and anxiety. If altering the gut microbiome results in better GI and emotional function, it     could improve the quality of life for children with ASD and their parents. A pilot trial with     12 children with ASD will test feasibility for a proposed three-site crossover randomized     clinical trial (RCT) of probiotics (beneficial bacteria including Lactobacilli &     Bifidobacteria) in 60 children 3-12 years old with ASD, GI dysfunction, & anxiety. In a     balanced crossover children will be randomized 1;1 to Visbiome or placebo first, 8 weeks per     condition with 3 weeks washout between. The investigators have access to significant fecal     microbiome and metabolome data from NIH-funded Human Microbiome Projects (HMP) on similar-age     healthy and irritable-bowel children, with and without ASD. These will help leverage our     understanding of macrobiome changes that correlate with functional improvement of GI and     abdominal pain symptoms. Pilot study efficiency will also benefit from those HMPs having     already collected and analyzed baseline stools for some children with ASD, thus saving     significant costs for baseline stool analyses for the pilot.   "
29232|NCT02903017|"     Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments.     Although new drugs and endoscopic techniques were easily applied in various settings in this     condition, the role of local administered therapies such as antifibrinolytic agents remain     unclear. The investigators aimed to compare standard therapy (proton pump inhibitors,     endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in     upper gastrointestinal hemorrhage in a double-blind, randomized trial.   "
29233|NCT02903004|"     This is an open-label, prospective, multicenter, randomized Phase III, clinical trial     evaluating the efficacy and safety of trabectedin in BRCA1 and BRCA2 mutation carrier and     BRCAness phenotype advanced ovarian cancer patients in comparison to physician' choice     chemotherapy.      Arm A: Trabectedin 1.3 mg/mq d1 q 21 in 3 hours (central line) Arm B: Pegylated Liposomal     Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/mq dd 1,8,15 q 28 or Gemcitabine 1000 mg/mq dd 1,     8, 15 q 28 Weekly Paclitaxel 80 mg/mq gg 1, 8, 15 q 28 Carboplatin AUC 5-6 q 21 or 28      Patients will be randomly assigned in a 1:1 ratio to treatment arms. During the randomization     process, patients will be stratified by        -  Platinum sensitivity        -  Measurable disease        -  Number of previous chemotherapy lines > vs < 3        -  BRCA mutational status   "
29271|NCT02902510|"     This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.   "
29234|NCT02902991|"     Through this prospective clinical trial,the investigators will focus on the relationship     between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA and     other biomarkers) and the status of primary tumor to discuss its application for assessing     prognosis and individualized therapeutic direction. Moreover, the relationship between the     circulating tumor cell subpopulations based on epithelial-mesenchymal transition and     molecular pathological classification of breast cancer will be determined, which may enable     the determination of the value of its application in therapeutic decision making.   "
29235|NCT02902978|"     The primary purpose of this study is to evaluate the safety, tolerability, and     pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.   "
29236|NCT02902965|"     This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in     combination with bortezomib and dexamethasone for patients with relapsed or relapsed and     refractory multiple myeloma.   "
29237|NCT02902952|"     Anxiety is one of the most frequent comorbidities in children with ASD leading to poor     clinical outcomes. Physical exercise has been shown to be a promising and easy to implement     intervention for reducing anxiety. However, little is known about the feasibility and     efficacy of physical exercise to reduce anxiety in children with ASD from underserved,     low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino     families will be recruited for the study and assigned to an exercise intervention group and a     sedentary control group. The physical exercise program is an eight-week program, administered     three times per week in small groups. Compliance, parent-rated anxiety, and salivary cortisol     will be measured before and after completion of the exercise and control group interventions.   "
29238|NCT02902939|"     Pro- and anti-inflammatory response during the formation of the critical state develops at     the same time. Because of its balanced or unbalanced systemic inflammation can be either     aborted or able to lead to multiple organ failure. With regard to sepsis, systemic     inflammatory response characteristics are well understood, is not achieved in respect of the     sterile inflammation.      Extracorporeal circulation is a clinical model of systemic inflammatory response due to     non-physiological activation of tissue factor in the extracorporeal perfusion, the use of     non-pulsatile circulation mode, intentional / unintentional hypothermia, bacterial     translocation from the gastrointestinal tract and perfusion deficit.      We have proved that the monocytes demonstrate suppressor function, which can be a predictor     of complications from cardiac surgery patients.      The most important component of the formation of multiple organ failure (MOF) in critically     ill patients is immunosuppression.      During the study of experimental and clinical tumor growth process scientists has provided a     new population of immature myeloid cells (myeloid suppressor cells or suppressor cells of     myeloid origin, MDSC). Most of the works have been devoted to the role of MDSC in the     development of tumors, where it has been clearly shown that this cell population has an     undoubted effect of immune suppression. However, recent studies show that the role of MDSC is     not limited to cancer process, but extends to chronic or acute inflammation.      The aim of this study is to determine the role of MDSC in the development of immune     suppression and complications after heart surgery carried out under cardiopulmonary bypass.   "
29239|NCT02902926|"     IBS is a global disease, patients often because of long-term symptoms of recurrent, not     timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect     the quality of life, and cause the corresponding economic and social burden.At present，a     number of studies suggest that fermentable oligosaccharides, disaccharides and     monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized     controlled trials are limited, leaving clinicians with the challenge of providing patients     with reliable guidance based on minimal evidence.   "
29240|NCT02902913|"     Data from limited dietary intervention trials suggest that the cardiovascular health benefit     of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs     contain an array of bioactive compounds, little information exists regarding the     physiological effects of specific chemical species. Among the EVOO-derived phenolics with     demonstrated anti-inflammatory effects in animal and in vitro models is oleocanthal, an     inhibitor of cyclooxygenase (COX). The current study compared the impact of acute intake (40     mL) of EVOO on platelet reactivity in healthy adult males (n=9). The volunteers were randomly     assigned to consume three EVOOs in a double-blind controlled trial. The EVOO were     characterized and chosen for equivalency in their total phenolic content and fatty acid     profiles, but differing in their oleocanthal to oleacein ratio.   "
29241|NCT02902900|"     This study, a national, multicenter, observational, ambispective, non-interventional study,     will be conducted in French hospitals prescribing pomalidomide and already participating in     the ongoing Imnovid registry.      This study will add to the registry. Indeed, pomalidomide-prescribing physicians and     pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who     have been prescribed this drug since the date on which it was marketed regardless of the     initiation date of pomalidomide or the indication for which it was prescribed.   "
29242|NCT02902887|"     This study presents an opportunity to understand a novel, previously unreported controlled     intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of     Intermittent exotropia (IXT).   "
29243|NCT02902874|"     To study the correlation between the polymorphism of the main immunity genes and     progression-free survival in ALCL of the child.   "
29244|NCT02902861|"     This is a multicenter, multinational (12 centers planned, in Germany 9 centers and in France,     the Netherlands and the United Kingdom (UK) 1 center in each country respectively),     randomized, double-blinded, placebo-controlled study. The primary objective is to evaluate     the efficacy of methotrexate (MTX) in patients with moderate to severe Psoriasis compared to     Placebo as assessed by the primary endpoint 75% reduction of Psoriasis Area Severity Index     (PASI 75 ) during a 16 week treatment phase. As secondary objectives the safety and efficacy     of the optimized treatment schedule will be assessed using multiple methods (e.g. (Serious)     Adverse Events ((S)AE) occurrence and questionnaires)   "
29245|NCT02902848|"     The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation     state (prothrombin time) measured inside the therapeutical zone and thanks to a portable     monitor. The values obtained at the point of care will be compared to the standard biological     assessment.   "
29246|NCT02902835|"     The goal of this study is to test whether peer mentors (i.e., individuals with past opioid     addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone)     treatment for individuals with opioid use disorder who were recently released from jail or     prison. In order to test whether it is helpful to have peer mentors paired with recently     released individuals, the investigators will conduct an 18 month study, recruiting 72     formerly incarcerated individuals and assigning them by chance selection (like flipping a     coin) to either a group that will receive peer mentorship or a group that will receive a     referral to a community clinic.   "
29247|NCT02902822|"     The purpose of this study is to demonstrate the validity and utility of a tele-dermatology     system in the midterm periodic screening of non-widespread skin lesions of recent onset or     for which a specialized early classification is deemed to change the prognosis - including     precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to     control visits at fixed follow-up.   "
29248|NCT02902809|"     A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese     Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus     Long-Acting β2-Agonist   "
29249|NCT02902796|"     A randomized controlled with cross over study compares efficacy of burst stimulation, 1000     hertz stimulation, and standard stimulation in an non-superiority trial. The study duration     is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks with     approximately 4 days of wash off in between.   "
29250|NCT02902783|"     The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that     observes the ICU management of consented deceased organ donors at 4 high volume centres over     a period of 12 months each. The pilot study will be followed by a 1-year prospective national     observational study a 15-20 ICUs across Canada.   "
29251|NCT02902770|"     The literature regarding analgesic modalities, their combinations and routes of     administrations for patients with pain related to renal colic is expanding. NSAID's (IV     ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic either     alone or in combinations. Despite their synergism and analgesic superiority when administered     together, both classes of these medications possess a set of unfavorable side effects that     limit their use. Emerging data of the use of IV lidocaine for patients with renal colic     demonstrated good analgesic efficacy and safety profile. However, none of the trials directly     compared lidocaine to ketorolac or the combination of both as viable options in patients     unable to tolerate or to have serious contraindications to opioids. We designed a     double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and     feasibility of non-opioid analgesics and their combinations in patients with renal colic. The     hypothesis and proposed study will try to determine if a combination of IV lidocaine and     reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid     analgesic modality is effective for controlling pain of renal colic origin.   "
29252|NCT02902757|"     This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron     emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response     in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a     patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the     tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the     start of therapy may help identify very early therapy response in patients with glioblastoma.   "
29253|NCT02902744|"     Primary Objective:      • To collect post-approval safety data related to intraocular pressure (IOP) after one or     more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).      Secondary Objectives:      • To collect visual and anatomic outcome data after one or more injections of Iluvien as     standard of care in subjects with diabetic macular edema (DME).   "
29254|NCT02902731|"     SYNOPSIS The giant cell arteritis (GCA) is the most frequent vasculitis in people over 50     years. Despite recent progress and physiopathogenic, corticosteroids remains the standard     treatment for decades with a very good initial clinical efficacy but a high relapse rate     (nearly 40% to 6,5 months) during its decay. This sensible population is particularly exposed     to the side effects of corticosteroids, leading to think about savings strategies. But the     association of immunosuppressive therapy and/or anti- TNFα has not demonstrated benefits in     terms of efficiency or long-term tolerance to cumulative doses of prednisone. The     responsibility of proinflammatory cytokines such as TNFα, IL- 6 and IL-1 has been studied in     the pathogenesis of GCA in temporal artery walls and in mouse models. The primary pathogenic     role of IL- 1 is based on the increase in serum or nuclear protein itself or that of its     mRNA. The study of temporal artery biopsies has shown increased local production of IL- 1β     mRNA, IL- 6 and TGFβ (indicative of macrophage activation ) and those of INFɣ and IL 2     (indicative of T lymphocyte activation). Recently, Ly et al (Ly KH JBS 2014) reported the     efficacy of anakinra, a recombinant molecule of IL- 1RA specifically blocking the IL- 1 α/β,     in three cases GCA refractory to conventional treatments.      Here investigators propose a randomized, multicenter, controlled, double-blind study of     anakinra against placebo in addition to corticosteroids in the treatment of GCA.      This study will include 70 patients randomized equally in both arms: reference treatment     (prednisone plus placebo) or the experimental treatment (prednisone + anakinra). Treatment     with prednisone will be identical in the two arms, namely a dose of 0.7 mg/kg/day orally on     day 1, followed by a progressive decrease in the dose pattern depending on the weight. In the     experimental arm, dose of anakinra is the one usually used, ie 100 mg/day by subcutaneous     injection from day 1 until the end of week 16 (S16). In the reference arm of the treatment, a     placebo anakinra is associated with corticosteroid in the same packaging, duration and     respecting the double-blind.      Investigators thus hypothesized that the addition of anakinra to corticosteroid compared to     placebo added to the latter, will show a significant decrease in GAC relapse rate. Indeed,     the challenge of corticosteroid therapy in this disease is not so much a problem of initial     effectiveness, than the adverse events related to relapses and steroid dependence.   "
29255|NCT02902718|"     The purpose of this pilot study is to evaluate the feasibility of the Mē device for at home     facial skin rejuvenation.   "
29272|NCT02902497|"     The goal of this study was to evaluate, in the hands of an inexperienced surgeon, the     cochleostomy location of an endaural approach (MINV) compared to the conventional posterior     tympanotomy (MPT) approach. Since 2010, the investigators use in the ENT department of Nice a     new surgical endaural approach to perform cochlear implantation. In the hands of an     inexperienced surgeon, the position of the cochleostomy has not yet been studied in detail     for this technique. This is a prospective study of 24 human heads. Straight electrode arrays     were implanted by an inexperienced surgeon: on one side using MPT and on the other side using     MINV.   "
29273|NCT02902484|"     The study will perform a clinical study evaluating the safety and tolerability of nintedanib     when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic     pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast     enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and     microvessel density.   "
29256|NCT02902705|"     Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and     dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the     underlying mechanisms of these disturbances remain elusive. Many in vitro studies have     demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic     environment. In good agreement, several animal experiments have reported that chronic kidney     disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid     redistribution. The goal of this protocol is to collect and study structural and metabolic     properties of white adipose tissue in CKD stage V patients to evidence adipose tissue     dysfunction associated with CKD. The primary outcome measure will be the cellularity of the     adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene     expression profile using microarray and metabolic properties of adipose tissue (i.e.     lipogenesis). To this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed CKD     stage V patients, matched for age, gender and body mass index (BMI) will be recruited at the     Departments of Nephrology or Urology of Lyon University Hospital (Lyon, France). The biopsies     of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective     urologic surgery (i.e. peritoneal dialysis catheter for CKD patients and radical     prostatectomy for non CKD patients).   "
29257|NCT02902692|"     The current study will examine the effects of a brief mindfulness based intervention (BMBI)     on mood, memory and attention in comparison to a wait-list control (WLC) group. Participants     for the study will be 90 adults aged 50 years and above who have presented at a memory clinic     within SLaM NHS Trust with subjective cognitive concerns and/or those who have received a     diagnosis of mild cognitive impairment (MCI) from their memory clinic.   "
29258|NCT02902679|"     An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants     before and after a hemodialysis session to evaluate safety, tolerability, and     pharmacokinetics in this patient population.   "
29259|NCT02902666|"     The purpose of this study is to evaluate the bioequivalence of a new paracetamol 1000     mg/codeine 30 mg formulation vs. the marketed reference Co-efferalgan® 500 mg/30 mg in terms     of rate and extent of absorption, when administered as single oral dose (one tablet of the     new A.C.R.A.F. formulation vs. two tablets of the reference formulation Co-efferalgan®) to     healthy male and female volunteers, under fasting conditions, in two consecutive study     periods.   "
29260|NCT02902653|"     This study evaluates the efficacy and safety of the administration of oral misoprostol versus     vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction.   "
29261|NCT02902640|"     This is a pilot, observational and multicentric study of safety of sulfamethoxazole plus (+)     trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis.     Overall, 50 adult participants with acute bronchitis eligible for treatment with     sulfamethoxazole + trimethoprim + guaifenesin will be enrolled. Administration of Balsamic     Bactrim will be according to physician's recommendation under local labeling.   "
29262|NCT02902627|"     l'ANI (Analgesia Nociception Index      The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a     parameter giving the possibility of measuring the pain in painful metastatic cancer. The     parameter ANI is compared with visual analogical scale (VAS) score.   "
29263|NCT02902614|"     Selection of side of embryo biopsy that will not interfering with implantation power of     developed blastocyst embryo during biopsy procedure arranged for PGT.   "
29264|NCT02902601|"     The primary purpose of this study is to investigate the safety and tolerability of JNJ     54175446 in participants with Major Depressive Disorder (MDD).   "
29265|NCT02902588|"     The purpose of the study is to confirm the applicability and usefulness of the novel method     of assessment of the permeability of the blood-brain barrier and in monitoring of the     treatment of patients with meningitis. The proposed technique is based on evaluation of the     kinetics of the indocyanine green (ICG) outflow from the brain with the use of near-infrared     spectroscopy (NIRS). Usefulness of the NIRS-based method will be analyzed in relation to the     reference method, which is contrast-enhanced magnetic resonance imaging (MRI).   "
29266|NCT02902575|"     The purpose of this study is to explore the safety, feasibility, long-term and     oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after     neoadjuvant chemotherapy.   "
29267|NCT02902562|"     This study is about using contrast-enhanced ultrasound (CEUS) to assess the degree of     synovitis (joint inflammation) in patients with inflammatory arthritis, such as rheumatoid     arthritis, and whether it can be used for assessing a treatment response. The investigators     hope to learn whether contrast enhanced ultrasounds are better than regular imaging     techniques, such as MRI, when used to evaluate the response to disease modifying     anti-rheumatic drug (DMARD) therapy in inflammatory arthritis.   "
29309|NCT02902016|"     This study is designed to assess the effect of a new PPARgamma modulator on the expression     and activity of the lactase enzyme in human intestinal epithelial cells. Based on their     previous experimental results, the investigators hypothesized that modulating intestinal     PPARgamma activity is a new pharmacological mechanism allowing the control of lactase     expression and activity in the gut   "
30236|NCT02889939|"     The aim of this project is to investigate whether it is possible to improve the functioning     and activity level for individuals more than 6 months after stroke by partaking in a     rehabilitation program consisting of high-intensity task-specific, goal-directed training in     an enriched environment.   "
29268|NCT02902549|"     Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in     real-time during surgery. Complications due to vascular compromise are a major problem,     especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue     necrosis. If, however, perfusion and ischemia could be monitored during surgery, then     surgeons could change their reconstructive design and the anaesthesiologists could improve     perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a     tool that is able to image in high resolution (microvascularisation), direct,     intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying     vessels) and that produces quantitative data to objectify image interpretation.      Optical techniques, based on the interaction of light with tissue, are able to image tissue     at high resolution and in real-time. These techniques are FDA-approved and have emerged as     powerful diagnostic tools in different departments of medicine, such as ophthalmology for     visualizing retina vascularisation and dermatology for skin diagnostics.      In this study, investigators hypothesize that four novel optical technologies: Fluorescence     Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream     Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.   "
29269|NCT02902536|"     This is a study during which the investigators collect plasma and cells from patients with     myasthenia gravis for the purpose of finding new antibodies.   "
29270|NCT02902523|"     A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and     pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir     Disoproxil Fumarate) in healthy male volunteers   "
29277|NCT02902432|"     The purpose of this study is to evaluate the efficacy and safety of recombinant human     endostatin（continuously-pumped）combined with chemoradiotherapy in patients with advanced     squamous cell carcinoma of the head and neck. The patients will be randomized to concurrent     radiotherapy (CRT) arm and CRT + Endostar arm. All patients will receive one cycles of     induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin     and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for     a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous     pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1,     d3-d7, d10-d14, d17-d21) during IMRT.   "
29278|NCT02902419|"     A randomized controlled trial measuring surgical site infection rate as a function of timing     of wound dressing removal.   "
29279|NCT02902406|"     This is a follow up study which aims to evaluate the correlation between several methylated     genes (potential biomarkers) and oral cancers. A prospective case control trial is designed     with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion     or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the     National Taiwan University Hospital Research Ethics Committee. After signing the informed     consent, all subjects will receive an intraoral examination and followed by epithelial cells     collection with oral swab. The gDNA will be extracted from the oral swab collected cells and     followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be     subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical     sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis     confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.   "
29280|NCT02902393|"     Revascularisation using recombinant tPA is the reference treatment of stroke. However, the     efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have     been associated with revascularisation efficacy.      The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with     stroke with thromboelastography and to correlate results with the clinical outcome of     patients. Results may predict revascularisation in patients with stroke.   "
29281|NCT02902380|"     Surgical stress induces stress hormone release and sympathetic hyperactivation.     Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study     investigate the effect of dexmedetomidine on stress responses and autonomic nervous system     balance in patients undergoing major spine surgery.   "
29282|NCT02902367|"     Eighty community-living individuals in Uppsala municipality will be included. Intervention:     Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments,     questionnaires and medical records. Assessment of motor function, cognition, level of     physical activity, food intake and perceived stress are performed at screening as baseline     measurements. Walking capacity, mobility, handgrip strength, body composition and     cardiovascular risk markers will be assessed at baseline and after 12 week of training. At     one year after training health-related quality of life, another cardiovascular incidence and     mortality will be documented.   "
29283|NCT02902354|"     To determine the central blood pressure changes in normotensive women who are receiving     nifedipine for uterine contraction suppression   "
29284|NCT02902341|"     Background: Malnutrition is widespread among cardiac surgery patients and is independently     related to an adverse postoperative evolution or outcome. The investigators aimed to assess     whether nutrition therapy (NT) could alter caloric deficit, morbidity, and mortality in     patients scheduled for non-emergency coronary artery bypass graft (CABG) or aortic valve     surgery.      Methods: 351 patients undergoing either elective CABG or aortic valve surgery were studied.     Patients receiving NT were enrolled from January 2013 until December 2014. A historical     control group consisted of 142 matched patients. Preoperative nutritional status was     evaluated. Resting energy expenditure was measured using indirect calorimetry or calculated.     Caloric intake and caloric deficits were assessed. The primary endpoint was to evaluate     whether NT could limit caloric deficit (Intake to Need Deviation). A secondary endpoint     addressed the potential effect of NT on morbidity and mortality. Patients were followed for     one year after surgery.   "
29285|NCT02902328|"     SIS has developed a software technology, based on machine learning and image processing,     designed to enhance standard clinical images for the visualization of anatomical structures.   "
29310|NCT02902003|"     The Parenting Center (TPC) offers the Empowering Families program, which integrates a     relationship education curriculum (Family Wellness) into a comprehensive set of services that     includes case management, employment services, and financial coaching. The evaluation will     test the effectiveness of offering relationship skills education services with a robust     economic security component to low-income couples raising children.   "
29286|NCT02902315|"     Acutely resistance exercise induces inflammatory responses and leukocytosis arising of     oxidative stress, that clinically manifested by pain and/or delayed onset muscle soreness     (DOMS). Beginners in resistance exercise programs are more vulnerable to the effects of     oxidative stress as they exhibit lower antioxidant capacity, greater lipid peroxidation and     present increased perception of pain after exercises that may lead to abandonment the     exercises practice. Vitamins C and E are exogenous antioxidants which are able to prevent     damages caused by oxidative stress. Cryotherapy decreases temperature and reduced generation     of reactive oxygen species. The aim of the present research are to investigate the effects of     the concomitant of vitamins and of cryotherapy on leukocytosis, inflammatory markers,     oxidative stress parameters and pain in untrained individuals submitted to a resistance     exercise session.   "
29287|NCT02902302|"     The main objective of the study is to evaluate the bioequivalence of a new formulation of     ibuprofen 400 mg/10 mL oral suspension vs. the marketed reference product MOMENTACT 400 mg     film-coated tablet, when administered under fasting conditions as single oral dose to healthy     male and female volunteers, in two consecutive study periods.   "
29288|NCT02902289|"     The main objective of the study is to evaluate the bioequivalence of a new formulation of     ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg coated     tablet, when administered under fasting conditions as single oral dose to healthy male and     female volunteers, in two consecutive study periods.   "
29301|NCT02902120|"     The purpose of this study is to determine whether patients treated for chronic hepatitis C     (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger     immune response compared to patients treated after kidney transplant. 25 patients with     chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant     recipients with chronic kidney disease will be treated with zepatier. Blood markers of immune     function will be monitored in both groups to determine their response to therapy.   "
29289|NCT02902276|"     In critically ill patients, the small bowel permeability is increased, leading to bacterial     translocation, and systemic inflammatory response syndrome.      Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide     (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of     bacterial translocation. The link between plasma citrulline and LPS in the critically ill is     unknown. Investigators hypothesize that patients presenting with low plasma citrulline     concentration, with presumed altered small bowel function, would have an increased phenomenon     of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to     evaluate the link between plasma citrulline and LPS concentrations in critically ill patients     at the time of ICU admission.   "
29290|NCT02902263|"     Early thrombolysis is essential in treating ischemic strokes. The time window for     thrombolysis is limited to 4,5 hours after symptoms onset.      In the French region of Franche Comté, in order to reduce the thrombolytic delay, a     telemedicine network was developed between the neurovascular reference unit (NVU) localised     in the University Hospital of Besançon and the peripheral hospital centres. Patients may then     be transported to the NVU immediately after the thrombolysis initiation.      The aim of our study was to assess the relevance of a systematic medicalization of transfer     to the NVU of patients with stroke who were telethrombolyzed before.      It was a retrospective, monocentric and observational study conducted over 24 months, in     Franche-Comte (France).   "
29291|NCT02902250|"     The purpose of this study is to compare the treatment efficacy between vertebral body     decompression procedure and vertebroplasty with non-inferiority design   "
29292|NCT02902237|"     In this phase I clinical trial cancer patients suffering from solid tumors or lymphomas,     recurring after and/or refractory against standard treatment are treated intravenously (iv)     with increasing doses of tTF-NGR(tTF= truncated tissue factor; NGR=Asn-Gly-Arg). The     objectives of this trial are to evaluate the maximum tolerated dose (MTD) and the     dose-limiting toxicity (DLT) of intravenously (iv) infused daily applications of tTF-NGR for     5 days every 3 weeks in patients with cancer, who had obtained all standard treatment known     for their disease entity prior to entry on study. Further objectives are to determine the     perfusion and vascular volume fraction of measurable tumor lesions versus normal reference     tissue before and after tTF-NGR application by MRI as a biological surrogate parameter for     biological activity of the investigational medicinal product (IMP), tTF-NGR, and to obtain     pharmacokinetic data.   "
29293|NCT02902224|"     The objective is to investigate neuro-anatomical correlates of the regulation of energy     intake by means of functional MRI before and after bariatric surgery. Administration of     glucose as well as fructose is followed by functional brain MRI, and findings are correlated     with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese     humans.   "
29294|NCT02902211|"     This study will determine whether an ankle foot orthosis (AFO) improves walking performance     in patients with PAD from its first use. Additionally, the study will test walking     performance after a three month AFO intervention and will examine the feasibility of this AFO     intervention.      Data for evaluations will be collected from 50 patients with PAD. Fifty healthy age-matched     controls will be participate in one baseline gait assessment for comparison purposes. Both     groups between 40-85 years old.      Interventions and Evaluations Biomechanics evaluations: Patients with PAD will complete a     biomechanics evaluation at baseline, following three months of control (standard of care),     and following three months of AFO intervention. The evaluation will include measurement of     walking distances, gait function, physical activity, quality of life, energy cost, muscle     morphometrics, muscle activity, muscle oxygenation, and muscle strength and endurance while     walking with and without the AFO. Healthy controls will be assessed during one baseline     collection only and their participation in the study will then be finished.      Feasibility interview: All patients with PAD will participate in feasibility interviews that     will assess acceptability, demand, implementation, and practicality. Interviews will occur     1.5 months and following completion of the AFO intervention (not the control arm).      AFO and Control (standard of care) Intervention: Patients will wear an off-the-shelf, carbon     composite AFO that is adjusted for them for three months. The patients will be asked to wear     the AFO at all times except when they are in bed or showering/bathing. The instructions given     to the patients about walking will be to follow the instructions from their doctor regarding     risk factor management and exercise. The intervention order will be randomized and all     subjects will participate in both arms.   "
29311|NCT02901990|"     This study was aimed to conduct a 3-year perspective study to observe the immunological     effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated     population aged 3-7 years，and provide basis for adjusting MMR immunization strategy in     Jiangsu province, China.   "
29312|NCT02901977|"     Randomized double-blind parallel group study in patients with mild-to-moderate hypertension     to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks     with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.   "
29296|NCT02902185|"     HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS)     can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected     people must remain on treatment continuously to avoid viral rebound and progression to AIDS.     HIV persistence is thought to stem primarily from the presence of integrated copies of the     proviral genome within long-lived cells. Because active viral gene expression causes cell     death due to viral cytopathic effects and the immune response, long-lived cells likely harbor     transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular     reservoirs remains a major barrier to a cure. HDACi have the potential to activate (Kick)     these latently infected cells. This will make the HIV infected cells visible to the immune     system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate     (Kill) the infected cells. This study is subsequent to our NCT02513901. The purpose of this     study is to verify the efficacy of multi-dose Chidamide in combination with antiretroviral     therapy in HIV-infected adults with suppressed viral load in a randomized controlled clinical     trial.   "
29298|NCT02902159|"     A randomised controlled trial to compare the effect on wellbeing of an online peer review     website (Big White Wall) compared to freely available online information (NHS Moodzone) for     people with depression and anxiety.   "
29299|NCT02902146|"     This prospective, open-label trial randomizes adult patients intubated in the ED with a     Macintosh blade to use or not use a bougie for the first intubation attempt. The primary     outcome is first pass success.   "
29300|NCT02902133|"     This is a non-randomized pilot study of Acetazolamide administration in patients at high risk     for CSF leak after endoscopic skull base surgery.   "
29314|NCT02901951|"     The purpose of this study is to assess the long-term protection against HBV infection in     adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30     years ago   "
29302|NCT02902107|"     This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy     (IORT) device that offers several advantages over existing techniques of performing IORT. The     CivaSheet device in this study is already approved by the FDA and is not an experimental     device. This study will allow us to determine how feasible it is to implant the CivaSheet     into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible     side effects of the device. This study, if successful, may allow us to offer the CivaSheet     more widely as treatment option to future patients.   "
29303|NCT02902094|"     DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and     effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty     balloon in patients with symptomatic native AV fistula stenosis.   "
29304|NCT02902081|"     The purpose of this research is to examine the effect of cannabidiol (CBD), a cannabinoid     compound found in marijuana, on responses to emotional stimuli. Both preclinical and clinical     studies indicate that CBD may act to reduce anxiety without excessive sedative side-effects.     Thus the investigators hypothesize that CBD may reduce responses specifically to negative     emotional and social stimuli, including pictures and emotional faces, without altering     responses to positive stimuli. To examine this, the investigators will administer placebo,     300mg, 600mg, and 900mg CBD to healthy normal adults in a double-blind within-subjects study.     The investigators will measure subjective and subtle physical responses to positive and     negative stimuli using measures that have been characterized with classic anxiety-reducing     drugs and drugs of abuse. Further, the investigators will examine whether CBD-induced changes     in these measures of emotional response relate to changes in actual behavior in a controlled     social interaction. These results will allow the investigators to examine the potential     usefulness of CBD as an anxiety-reducing drug, and suggest mechanisms by which CBD may reduce     anxiety.   "
29305|NCT02902068|"     In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in     women undergoing cesarean section delivery.      This study is a purely observational study, it will not have any clinical intervention nor     will it interfere with standard cesarean delivery protocols in any way. This study's primary     objective is to evaluate how spinal and general anesthesia influences cardiac output during     cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as     measured in cardiac output correlate with women's pain, measured by a visual analogue     scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)   "
29306|NCT02902055|"     Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe,     life-threatening lung injury. Care for paediatric patient is mainly supportive and based on     what works in adults and personal experiences, including the use of mechanical ventilation.     However, differences in lung physiology and immunology between (young) children and adults     suggests that adaptation of adult practices into paediatrics may not be justified. A study in     adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA)     improved 90-day survival and increased time off the ventilator without increasing muscle     weakness. It is unknown if this is also true for paediatric ARDS   "
29307|NCT02902042|"     This study will investigate the influence of maintenance therapy on progression-free survival     (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase)     inhibitors and PD-1 antibody pembrolizumab.      In the safety phase I part the optimal dose of pembrilizumab in combination with BRAF     inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be     determined.      In the randomized part 2 different maintenance therapies will be tested for toxicity and     efficacy. Patients with disease control after 6 months of triple therapy will be randomized     to receive 2 different maintenance therapies further on, either continuation of triple     therapy or administration of pembrolizumab alone.   "
29308|NCT02902029|"     Most patients with locally advanced or metastatic tumors succumb to their disease. Thus,     there is a substantial need for novel therapeutic strategies to improve the outcome for     patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway     by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an     antiPD-L1 antibody have emerged as treatment option.      In this study the best timing for sequential use of both treatment options (BRAF/MEK     inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600     mutant melanoma will be assessed.   "
33432|NCT02848170|"     Phase 3 study to examine the relation between antihypertensive effect and baseline factors     exploratively, compared to olmesartan medoxomil in patients with essential hypertension.   "
29313|NCT02901964|"     Osteoarthritis (OA) is a prevalent disease associated with significant morbidity and is one     of the most common causes of joint pain. Characterized by their chronicity, slow and     progressive evolution. The overall prevalence of symptomatic knee osteoarthritis is estimated     at 3.8%, with peak prevalence in the population with an average age of 50 years. The main     objectives of interventions in patients with knee OA are reduced pain and improved functional     capacity and exercises are widely recommended. The literature shows a lack of clinical trials     verifying the effect of strengthening the hip muscles in patients with knee osteoarthritis.     Thus, the aim of this study is to assess the effect of strengthening the hip abductor muscles     versus hip adductor muscles in patients with symptomatic OA of the knee.   "
29315|NCT02901938|"     This study will investigate the effects of implantation of cemented femoral stem versus     percutanous internal fixation with cannulated compression screws on hip joint function     recovery, pains, femoral head collapse and sterile prosthesis loosening, peri-prosthesis     infection, and the histocompatibility of prosthesis material with host tissue in the elderly     patients with osteoporotic fracture of proximal femoral neck complicated by avascular     necrosis of the femoral head, which will provide scientific evidence for selecting surgical     methods and internal fixation/artificial prosthesis material for osteoporotic fracture of     proximal femoral neck in the elderly patients.   "
29316|NCT02901925|"     The primary study objective is to determine if microdoses of ABY-029 lead to detectable     signals in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining.      The secondary study objective is to assess diagnostic accuracy of ABY-029 detection by iFI     and intraoperative probe relative to histopathology diagnosis, and other indicators (e.g.     proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake     and concentration of ABY-029 in resected specimens.   "
29317|NCT02901912|"     Gut microbiota comparison of active and sedentary women   "
29318|NCT02901899|"     The purpose of this study is to look at how patients respond to treatment with guadecitabine     and pembrolizumab. The researchers will also be looking at the amount of time it takes for     cancer to get worse when participants take the study drugs. All participants will be treated     with guadecitabine and pembrolizumab. Guadecitabine interferes with the cancer cells' DNA and     can increase the production of certain proteins, making cancer cells more recognizable by the     immune system. Pembrolizumab helps your immune system to kill cancer cells. Thus the     combination of guadecitabine and pembrolizumab may increase the ability of the immune system     to eliminate cancer cells. Researchers want to find out whether the combination of     guadecitabine and pembrolizumab is effective in treating ovarian cancer that has not     responded to traditional chemotherapy. Participants will keep receiving treatment until their     cancer gets worse, they have side effects, or they decide they don't want to receive the     treatment anymore. After stopping treatment, the study doctor will watch participants for     side effects and follow their condition every 6-12 weeks. The study aims to keep track of     participants' medical conditions for the rest of their lives. This helps us look at the     long-term effects of the study drugs.   "
29320|NCT02901873|"     Parathyroid glands are involved in calcium metabolism and their damage during neck surgery     results in 'hypoparathyroidism', a condition characterized by 'low blood calcium' levels;     this is associated with significant short and long term morbidity. There are four parathyroid     glands in the neck which can vary in size and location. They can be mistaken for lymph nodes,     fat or thyroid nodules. A normal parathyroid gland is the size of a small pea and is often     difficult to recognize during surgery; making it susceptible to inadvertent injury or     removal.      Thyroid and parathyroid surgery are commonly performed in the UK. Prompt and accurate     identification of parathyroid tissue during surgery reduces the likelihood of     hypoparathyroidism. However, this complication is still common. Research exploring the use of     intraoperative technologies to enable early identification and preservation of normal     parathyroid glands during surgery is ongoing. Electrical impedance spectroscopy (EIS) is one     such technology. ZedScanTM is a handheld device that measures electrical impedance of     tissues. It is currently used as a adjunct during colposcopy in cervical cancer screening.     The device has a CE mark for this purpose and is safe to use in humans. We have already     demonstrated that electrical impedance spectroscopy can detect differences in cellular     structure and differentiate between tissues in the rabbit neck. We now aim to demonstrate the     feasibility of using this technology (ZedScanTM) in humans. This has potential to be used in     thyroid and parathyroid surgery to differentiate parathyroid glands from other structures;     thereby decreasing their damage and the risk of post surgical hypothyroidism.   "
29321|NCT02901860|"     The purpose of this research is to test the hypothesis that those with non-traditional work     schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with     traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the     degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of     this research are expected to increase our understanding of physiologic tolerance to     non-traditional work schedules and provide the basis for the development of methods for the     early detection of adverse health effects and determine coping strategies for the millions of     workers with non-traditional work schedules.   "
29322|NCT02901847|"     The aim of the project is to investigate the clinical and patient centred outcomes of people     with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway,     utilising advice on diet, activity and smoking cessation. The podiatry clinic will be     delivered from the Move More centre (NCSEM) and participants will be encouraged to access     these facilities as part of their activity programme which will be agreed with the physical     activity team. Primary and secondary outcomes will be clinical - claudication pain, distance     walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced     BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with     the programme will also be assessed.   "
29338|NCT02901639|"     Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are     also a great social and financial burden on societies and countries. According to     World-health-organization statistics, there are an estimated 200 million pregnancies around     the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy     also is a major health problem in the United States of America. In the 2002 National Survey     of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When     abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all     pregnancies   "
29323|NCT02901834|"     Adolescents with cancer (AWC) are in a unique developmental stage that may mean pain     characteristics, the impact of pain, and pain treatment outcomes are different in adolescents     compared to children and adults. In response, we will develop and test the PainSquad+ pain     management smartphone app. First, we will conduct usability testing to refine PainSquad+ so     that it is useable, acceptable and understandable for AWC. Secondly we will: (a) test the     feasibility of conducting a large-scale PainSquad+ experiment and (b) begin to examine how     effective PainSquad+ is at helping adolescents manage pain. We hope that once developed and     tested for effectiveness, PainSquad+ will improve pain treatment and ultimately quality of     life in AWC.   "
29324|NCT02901821|"     The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid     (miRNA) expression that are predictive of symptom duration and severity following mild     traumatic brain injury (mTBI) in children.   "
29327|NCT02901782|"     Microwave ablation of bone tumors is time-consuming and usually results in postoperative     fractures. Hence the investigators designed and fabricated a titanium plate customized to the     patient's bone structures for fixation after the removal of tumorous tissue, to improve the     clinical outcomes of microwave ablation.   "
29328|NCT02901769|"     Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But     as it can occur in patients with no psychiatric illness and doesn't occur in every patients     with psychiatric illness, it has to be considered henceforth as a specific vulnerability.      This trial will study two fMRI paradigms, emotional prosody recognition and decision making,     in order to characterize emotional and cognitive trait factors in a population of patients     vulnerable to suicide. Four different groups will be constituted : depressed suicide     attempters, depressed patients with past history of suicidal acts, depressed patients with no     history of suicidal acts and healthy controls.      The main goal will be to correlate fMRI activation during the two paradigms in subjects     vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive     trait factors in these subjects, to demonstrate that those characteristics are independent     from depression and to correlate these trait factors with socio-demographic and clinical     features with fMRI activations.   "
29329|NCT02901756|"     Adult patients suffering from migraine according to the criteria of the International     Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous     month; exclusion of chronic migraine and medication overuse) and after a one-month baseline     phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg     magnesium per day for 3 months.   "
29330|NCT02901743|"     The main aim and objective of this study was to evaluate the effects of Non- surgical     periodontal therapy on the subgingival microbiota and biochemical parameters in patients with     chronic kidney disease and chronic periodontitis.   "
29331|NCT02901730|"     Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a     simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an     existing angle close or angle adhesion in order to reduce the risk of attack of the angle     closure glaucoma. However, there are very little research on the laser site, laser     wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine     the optimum laser wavelengths of LPI.   "
29332|NCT02901717|"     This is a Phase 3, multi-center, randomized, double-blind study to determine the efficacy and     safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate     disodium in 25% ethanol solution.      Approximately 700 subjects who have been diagnosed with CRBSI/CLABSI and who meet all     necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:        -  MLT Arm: MLT + SOC intravenous (IV) antibiotic therapy; or        -  Control Arm (subjects randomized to the Control Arm will receive treatment based on the          type and virulence of the infecting organism as documented by the Investigator prior to          randomization)   "
29333|NCT02901704|"     The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal     denervation in subjects with primary hypertension by using Iberis multielectrode renal     denervation system   "
29334|NCT02901691|"     The deaf children showed deficits in speech processing and temporality. They badly apprehend     temporal concepts and perceptions of deficit so the acoustic phenomena marking the time     course linguistically. Their prediction capabilities and anticipation multisensory events are     thereby affected, thus impacting their ability to adapt to multiple and complex interaction     possibilities that arise during a conversation.The project aim it is to measure the impact of     a musical rhythmic stimulation of neuronal activity and the temporal prediction capabilities     of older deaf children 5 to 8 years and its impact on their language skills in a     conversational task. A matched control group of age will be examined for each of the proposed     tasks.      We first measure the capacity to anticipate a situation of language interaction. For this     purpose, we will use an alternate naming paradigm with a virtual partner, already developed     and tested in children with normal hearing. This paradigm approaches the conversational     situation while allowing control of the time parameter of speech (speed of trade) and by     controlling the bias (temporal) inherent linguistic programming difficulties of children in a     spontaneous conversation situations .      Then we will couple behavioral measurements with measurements of eye movements and the     electroencephalogram (EEG) in deaf children. For this, we use a dialog observation task     already developed for normal hearing children. This task will allow us firstly to analyze the     anticipation level of speaking turns by analyzing eye movements (which precedes the     speaker). Secondly, it will allow us to study the effects of manipulation of the acoustic     parameters of auditory evoked potentials (AEP) and the oscillatory activity of the motor     system (EEG, mu rhythm and beta). The audiomoteur coupling would seem to be the key point of     anticipatory processes and convergence in conversational interaction will also be studied     using cortico-cortical coherence techniques to assess the dynamics of connectivity between     remote networks (system here auditory and motor system).   "
29335|NCT02901678|"     A Randomized clinical trial comparing two different force magnitudes in maxillary posterior     segment intrusion in adult patients with skeletal open bite malocclusion   "
29336|NCT02901665|"     The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes     pre and post a planned unit-wide intervention aimed at increasing parent presence in the     Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an     expectation that all NICU parents be present at minimum 4 hours/day versus the current     practice of telling families to come as much as they can that has resulted in inconsistent     parent presence.   "
29337|NCT02901652|"     Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure     Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) in terms of mechanical     ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within     the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at     26-30 weeks of gestation.   "
29339|NCT02901626|"     The purpose of the study is to determine whether the Arabin pessary is a useful intervention     of preterm birth at less than 37 weeks in women with a singleton gestation and a short     cervix.   "
29340|NCT02901613|"     To evaluate the effectiveness of negative-pressure wound therapy in decreasing wound     complications in morbidly obese patients (BMI greater than of equal to 40) at Albany Medical     Center Hospital. Retrospective data will be collected regarding morbidly obese patients who     have undergone cesarean section and patients will be recruited to have the intervention     (negative-pressure wound therapy) applied and outcomes will be evaluated.   "
29341|NCT02901600|"     Although colorectal cancer is a preventable and curable disease if early stage tumors are     removed, it is still the fourth cause of cancer worldwide and the second leading cause of     death in many industrialized countries. The 5-year survival is about 55% often due to a late     detection. Then, the identification of sensitive and specific molecular markers is therefore     a major challenge for early diagnosis and prognosis of this disease.      Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant     brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during     several stages of colon carcinogenesis. The goal of this study is to study by mass     spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal     tumors of various stages, grades, and recurrence status.   "
29342|NCT02901587|"     The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity     in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or     schizoaffective disorder after 6 weeks of treatment   "
29343|NCT02901574|"     People with post-stroke aphasia are left with some degree of chronic deficit for which     current rehabilitative treatments are variably effective. This study investigates the     behavioral and neural effects of multiple consecutive cerebellar tDCS sessions coupled with     computerized naming therapy in stroke survivors with aphasia.   "
29344|NCT02901561|"     The purpose of the investigators' study was to evaluate whether misoprostol will improve pain     scores .   "
29345|NCT02901548|"     The purpose of this study is to test if an experimental drug called Durvalumab (Medi4736)     given by intravenous (IV) infusion is effective in treating carcinoma in situ (CIS) of the     bladder that no longer responds to Bacillus Calmette-Guérin (BCG) and to collect information     on the safety of these drugs and whether they cause any side effects.   "
29346|NCT02901535|"     The purpose of this study is to determine the effectiveness of telemedicine multifaceted     intervention in symptoms patients with chronic obstructive pulmonary disease.   "
29347|NCT02901522|"     The purpose of this study is to determine the effectiveness of telemedicine multifaceted     intervention in symptoms patients with asthma.   "
29348|NCT02901509|"     QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of     infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK     cohort by comparing scores of SF-36 health survey.   "
29349|NCT02901496|"     Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying     mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute     elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed     gastric emptying. Physical inactivity causes accumulation of visceral fat (VAT). Visceral and     epicardial adipose tissue (EAT) is more inflamed than subcutaneous adipose tissue. Thus, the     investigators hypothesize that exercise-induced IL-6 mediates the exercise-induced reduction     in EAT and VAT. Secondly, the investigators hypothesize that exercise-induced adaptations in     glucose metabolism and gastric motility are dependent on IL-6. Finally the investigators     hypothesise that both endurance and resistance exercise training reduce VAT and EAT.      Primary aim: To investigate the effects of exercise training on VAT and to determine to what     extend IL-6 mediates this effect.      Secondary aims: 1) To determine whether 12 weeks of endurance and strength training can     reduce the amount of EAT. 2) To study whether the effects of exercise on glucose metabolism     and gastric emptying are dependent on IL-6.      Methods: Inclusion: 70 inactive men and women, >18 years, waist to height ratio > 0.5 and/or     waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) Design: A 12-week,     double-blinded randomised, placebo-controlled exercise intervention study.      Intervention: Subjects will be randomised to one of five groups: i) Tocilizumab (IL-6     receptor antibody) and endurance training, ii) Placebo to Tocilizumab and endurance training,     iii) Tocilizumab, no exercise iv) Placebo to Tocilizumab and no training, and v) Placebo to     Tocilizumab, and resistance training. Tocilizumab/placebo dose will be administered     (according to standard recommendations) before the first training session, and maintained     during the 12-week training program. Training will be supervised to ensure intensity and     compliance. Subjects will be instructed not to change eating habits and informed that this     study does not aim for a weight loss.      Statistical considerations: Study investigators are blinded to treatment allocation. Dropouts     will be replaced. A sample size of 70 subjects is needed to detect a 10% change in visceral     adipose, with a power of 80% and a significance level of 0.05.   "
29350|NCT02901483|"     It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck     squamous cell carcinoma (HNSCC) patients.        -  Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in          this phase to identify the recommended intratumor injection volumes of PEP503.        -  Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18          additional patients will be enrolled at the recommended volume level to evaluate for          safety and efficacy.   "
29351|NCT02901470|"     The support of help to the prevention of sores include a big diversity of devices. The     clinical experiment of these support comes up against the problem of the large number of     factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to     estimate the incidence of bedsores in these supports, with control of other factors   "
29352|NCT02901457|"     Too many Norwegian adolescents experience severe body dissatisfaction (40-70 %), and strive     to accomplish the perfect body. At the same time, only 50 % meet the government`s     recommendations on physical activity and intake of fruits and vegetables. Also, 14-24 % has     unhealthy sleeping habits. Optimizing these lifestyle factors is associated with physical and     psychological health. These factors, along with the pressure to obtain the perfect body,     are threatening the adolescent`s physical and psychological health, jfr. Meld St nr 19. It is     now a need for knowledge on how the investigators can contribute to promote positive body     experience among the adolescents.      It has recently, through a controlled study on elite youth athletes at Norwegian sports high     schools, been shown that it is possible to change eating habits, improve body image and     reduce new cases of eating disorder. It is now desirable to test an adapted program through a     school-based program at regular Norwegian high school students (12th grade). Today, no     controlled, school-based intervention studies with long-term follow-up have been conducted.      The main aim of this project is to investigate if it is possible, through a school-based     intervention program (Healthy Body Intervention), to promote positive body image, increase     physical activity level, and healthy eating and sleeping habits in both boys and girls at     Norwegian high schools.      The intervention program will contribute with new evidence-based knowledge on the effect of     an adapted health-promoting program.   "
29353|NCT02901444|"     Stemming from the common practice of attribution of the technical helps in the posture in     Canada, the multidisciplinary approach of positioning develops in France for more than 10     years old.      To date, no observatory study was led to estimate the impact of such consultation in daily     activities, an essential objective conditioning the observance and the acceptance of     assistive devices. This study wants to estimate the impact through modification of WHOM     scale.   "
29354|NCT02901431|"     This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group,     placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of     RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning     (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment will be staggered,     starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12     years). Initially, a first cohort of approximately 24 adolescents will be enrolled together.     Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort     and determined final doses, enrollment of adolescents will resume and the enrollment of a     first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on     acceptable safety and tolerability in the first children cohort and determined final doses,     enrollment of children will resume.   "
29355|NCT02901418|"     Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important     reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is     the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine immediately     after birth is the most important method of blocking mother-to-child transmission of HBV.     However, regular doses of HBIG combined with hepatitis b vaccine blocking measures still have     a failure rate as high as 5% ~ 15%.There are numerous studies to explore pregnancy women with     HBV positive, especially high viral load of those women during pregnancy being treated with     nucleoside analogs to increase the blocking rate of HBV MTCT, but there is still a failure     rate of 2.2% to 18%. In this study, we will explore the efficiency of personalized blocking     method of HBV maternal-neonatal transmission in high-risk newborns,according to the venous     blood HBsAg state of neonatus at birth.   "
29356|NCT02901405|"     This randomised controlled trial aims to evaluate the difference in surgical site infection     following excision of soft tissue sarcomas. The intervention is a negative wound pressure     therapy dressing for 120 hours, the control is standard absorbent dressings   "
29357|NCT02901392|"     Stress urinary incontinence is a significant potential source of morbidity after radical     prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary     sphincter remains the preferred therapeutic option. However, this technique is not free from     complications. In an attempt to avoid such complications, male sling has been suggested for     use in patients with mild degrees of stress incontinence.   "
29358|NCT02901379|"     The purpose of this study is to determine whether atorvastatin 80mg can reduce the     development of myocardial edema following coronary artery bypass surgery.      This study also want to determine:        1. whether atorvastatin 80mg can influence Follistatin-like 1 (FSTL1) plasma level          following bypass surgery?        2. whether there is correlation between myocardial edema and FSTL1 plasma level?        3. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in reducing hs-CRP (high          sensitive-C reactive protein) and MDA (malondialdehyde) plasma level following bypass          surgery?        4. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in raising PKA and PKB          plasma level following bypass surgery?   "
29359|NCT02901366|"     To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites     of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.   "
29360|NCT02901353|"     A prospective, single-arm, multi-centre, observational, real world registry to evaluate     safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very     long coronary lesions.   "
29361|NCT02901340|"     The purpose of the study is to investigate third trimester fetal renal artery doppler indices     in borderline idiopathic isolated oligohydramnios and relationship between neonatal outcomes.   "
29362|NCT02901327|"     Chronic Mechanical Low Back Pain (CMLBP) is a common disabling health problem among the     general population. Multifidus muscle inhibition accompanying CMLBP plays a major role in     perpetuating the pain and functional disability. Lumbar stabilisation and treadmill exercises     are established treatments for CMLBP. However, it is not known which of the two techniques is     more effective. This study was conducted to compare the effects of lumbar stabilisation and     treadmill walk on multifidus activation, pain and functional disability in individuals with     CMLBP.   "
29363|NCT02901314|"     Non-adherence to the heart failure (HF) plan of care after hospital discharge has been     associated with clinical outcomes, including the combined endpoint of all-cause mortality and     rehospitalization for decompensated HF. Patients and informal caregivers receive education     materials but may not act due to multiple factors. A recorded message that could be     repeatedly played by patients and caregivers might increase adherence to post-discharge     self-care behaviors and early follow-up appointments, and have clinical benefits related to a     reduction in all-cause mortality and rehospitalization. The purposes of this randomized,     controlled study are to examine the effects of use of a novel MyROAD (Recordable On-Demand     Audio Discharge) card, given to patients at discharge. The aims of this single-blind,     placebo-controlled study are to examine the effects of recorded messages that can be replayed     post discharge (delivered via the MyROAD card) on multiple subjective and objective clinical     outcomes.   "
29398|NCT02900859|"     Systematic medical chart and imaging files review of patients presenting with non-lymphoma,     non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI     infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic     disease (IgG4-ROD) and other patients.   "
29399|NCT02900846|"     Retrospective medical charts and medical imaging files review of patients suffering from     lacrimal fossa lesions who underwent ocular ultrasonography with color flow doppler imaging.   "
29433|NCT02900404|"     This study shall determine whether XAPPORT - a mobile device app based on different     guidelines, the summary of product characteristics of rivaroxaban, and clinical facts and     practice - provides adequate guidance to physicians attending patients undergoing elective     surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to     approach the pre- and postoperative management of anticoagulation.   "
29364|NCT02901301|"     Gastric cancer is one of the major health problems worldwide, and one of the leading cause of     death especially in Asia. Though the cytotoxic chemotherapy is the main treatment option,     newer and molecularly targeted agents are recently incorporated to improve the survival     outcome. Human epidermal growth factor receptor 2 (HER2, ErbB2) is a transmembrane tyrosine     kinase receptor and is overexpressed or amplified in 10-20% of gastric cancer. Recently,     Trastuzumab for Gastric Cancer (ToGA) study reported the clinical benefit of trastuzumab for     HER2 positive gastric cancer patients. However, because the majority of patients develop     intrinsic or acquired resistance within 1 year, elucidating the molecular mechanisms for     trastuzumab resistance is warranted to improve the survival outcome of HER2 positive gastric     cancer patients.      A growing body of preclinical and clinical evidence shows that the immune system contributes     substantially to the therapeutic effects of monoclonal antibody, trastuzumab in solid     tumors. Pembrolizumab is a potent and highly selective humanized monoclonal antibody designed     to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.      Based on strong rationale in exploring the impact of combining trastuzumab with anti-PD-1     inhibitor in HER2 positive cancer, we suggest multicenter phase IB/II study to determine     antitumor activity and safety of pembrolizumab in combination with standard treatment     (trastuzumab, capecitabine, and cisplatin) in patients with HER2 positive gastric cancer.   "
29365|NCT02901288|"     The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for     newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World     Health Organization recommended standard 6-month regimen.   "
29366|NCT02901275|"     This research is being done to evaluate whether combining medications that are FDA approved     but have not yet been approved for combination treatment, can be an effective way to reduce     pain.   "
29367|NCT02901262|"     To evaluate the ability of NICU staff to interpret, before and after a training period,     symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG tracings.   "
29368|NCT02901249|"     To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using     medications available in the Brazilian Public Healthcare System (SUS), and assessment of the     quality of life of these patients.      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of     episodes of unipolar depression episodes.   "
29369|NCT02901236|"     Refractory glaucoma often requires vision-sparing trabeculectomy. To increase surgical     success, adjunctive pharmacotherapy is utilized albeit the risk of adverse events. This     prospective trial randomizes adults with uncontrolled glaucoma to assess an emerging healing     modulatory strategy. Over a 1-year follow-up, trabeculectomy complemented with intracameral     delivery of anti-angiogenic bevacizumab (1.25 mg) is compared to standard trabeculectomy with     anti-fibrotic mitomycin-C (0.02%; applied for 2 minutes).   "
29370|NCT02901223|"     The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its     impact on patient satisfaction and is it worthy for general breast surgeon to learn different     oncoplastic techniques.   "
29371|NCT02901210|"     The aim of this study is to evaluate the investigator new modification for delorme procedure     in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .   "
29372|NCT02901197|"     The purpose of this dual-site quasi-experimental pilot study is to evaluate if the     implementation of an educational intervention paired with an environmental assessment to     address accessibility barriers is associated with improvement in staff knowledge and skills,     and adherence to national guidelines for use (evaluation in the knowledge transfer framework)     in an emergency department (ED) setting.   "
29373|NCT02901184|"     Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without     therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart     Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFPEF, but     it is generic and will not be studied by industry.      SPIRRIT is a unique Registry-Randomized Clinical Trial (RRCT) that will test the hypothesis     that spironolactone reduces all-cause mortality in HFPEF and is summarized by PICO (Patient     Intervention Comparison Outcome) as follows: Population: HFPEF patients in the Swedish Heart     Failure Registry. HFPEF defined as symptoms/signs of HF, elevated NTproBNP (B-type     Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF>=40%. Intervention and     control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual care     alone.      Outcome: Primary outcome all-cause mortality. Secondary outcomes include hospitalization for     various causes, adverse events and treatment adherence. Outcomes are obtained automatically     by linking with the Population, Patient and Drug Dispensed Registries. The trial is     event-driven with enrollment 3 years and study duration 5 years. Based on actual patients     meeting eligibility 2008-2010, the control death rate is 0.141 / year. Based on TOPCAT and     accounting for dropouts, the investigators conservatively assume hazard ratio 0.85, or a     clinically meaningful 15% reduction in death, yielding a required number of events of 1208     and a sample size of 3335, conservatively rounded to 3500. A detailed feasibility assessment     shows that there will be > 8197 eligible patients to meet the required enrollment of 3500.   "
29374|NCT02901171|"     The purpose of this study is to evaluate the efficacy of a smartphone application in     enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study     also aims to elucidate the processes through which the treatment promotes smoking cessation     and for whom it is most effective.   "
29375|NCT02901158|"     Esophageal pressure measurements are used in to determine chest wall elastance and calculate     lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated     esophageal balloon catheter is then placed in the esophagus to measure tidal variations in     esophageal pressure.      In this study high resolution solid-state manometry technique was used to provide detailed     and continuous measurements of esophageal pressures in the different parts of the esophagus.     Measurements were performed during ongoing mechanical ventilation at different levels of     endexpiratory pressure.   "
29376|NCT02901145|"     patients with progressive/relapsed solid tumors who failed first line therapy , will be     treated biweekly with the anti PD1- Nivolumab. at least one month after treatment initiation     low dose cyclophosphamide will be started .      patients on trial will submit tissue and blood tests for whole exome an immune genomic     signature. patients will also undergo repeated immunophenotype as part of follow up.   "
29377|NCT02901132|"     Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival     and quality of life. The etiology of malnutrition in cancer patients is multifactorial,     therefore, the nutritional assessment should be carried out by different parameters. The     objective of this study is to investigate the association and prognostic value of five     distinct methods of nutritional assessment (molecular, body composition, functional,     anthropometric and subjective) in relation to postoperative complications and short-term     survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon     will be assessed in rectus muscle samples, harvested in the moment of the operation. Body     composition was assessed by computed tomography (CT) and bioelectrical impedance test was     conducted to evaluate the phase angle. Handgrip strength was used to determine functionality.     The percentage of weight loss in relation to usual weight was the anthropometric parameter     used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis.     Postoperative complications were classified according to the Dindo and Clavien     classification. Overall time survival was the period between the first assessment of the     patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and     the Log Rank test and regression analysis will be used (p <0.05).   "
29378|NCT02901119|"     Malnutrition is prevalent among chronic liver disease patients. Inadequate ingestion and/or     metabolic alterations modify the body composition and biological functions. The purpose of     this study is to determine whether whey protein comsumption, due to amino acid profile,     digestibility and bioactive compounds may be beneficial for patients waiting for liver     transplantation   "
29379|NCT02901106|"     The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting     multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two     randomised, placebo phase-controlled III international studies, organized by the     pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received     European approval on January 30, 2014, for the treatment of adult patients with relapsing     remitting MS.      Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of     a physician experienced in the treatment of the disease.      It has proved effective to reduce the number of relapses in patients with recurring-remitting     MS and reduce the number of patients who have relapses during treatment.      The objective of the study is to observe, in real conditions, on the one hand the tolerance     and the other evolution, clinical and radiologic disease in patients already treated by     dimethyl-fumarate and collect long-term safety data.   "
29380|NCT02901093|"     Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is     usually performed to identify an underlying cause, such as excessive intravestibular     penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.      Unfortunately, there is very little data in an unselected series of uneventful patients.      The aim of this study is to analyze the depth of prosthesis penetration within the vestibule     and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone     Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate     imaging findings to clinical outcome. This prospective monocentric study is conducted in a     tertiary referral medical center. A CBCT is performed in 80 consecutive patients having     undergone stapes surgery for otosclerosis, the day or the day after the procedure.     Penetration length and location of the prosthesis within the vestibule, as well as presence     or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo,     nystagmus, hearing measurement).   "
29381|NCT02901080|"     This is a single-centre research study in patients seen within an NHS Improving Access to     Psychological Interventions (IAPT) service with suspected generalised anxiety disorder (GAD).     The study will involve 120 patients from the Leicestershire and Rutland area in England,     United Kingdom.      Participants will use the Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) medical     device, which is approved for use and proven to be safe and work for the treatment for     anxiety, depression and insomnia.      Participants will use the Alpha-Stim AID for 60 minutes every day for 6 or 12 weeks, either     whilst on the waiting list for standard care treatment from IAPT, or in conjunction with     standard care treatment from IAPT.      The study will involve 6 study visits - one face-to-face at visit 1, followed by 5 visits via     telephone at week 4, 6, 8, 12 and 24. At each visit, participants will be asked to complete     questionnaires to assess anxiety, depression, sleep difficulty, quality of life and work and     social functioning.      The purpose of the study is to gather evidence for the clinical benefits and cost     effectiveness of the Alpha-Stim AID when used in an NHS setting - how well does it work, and     does it's use result in cost savings for the NHS.      The study may show that the Alpha-Stim AID should be available on the NHS for patients with     suspected GAD.   "
29382|NCT02901067|"     This is a phase II, pragmatic, prospective, randomized, double-blind, adaptive clinical trial     examining the efficacy of statins and aspirin in the reduction of acute lung injury and     venous thromboembolism in patients with fibrinolysis shutdown.   "
29383|NCT02901054|"     Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing     after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron     might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by     investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability     that may affect that distribution.      Study procedures will include iv ondansetron administration, serial blood draws,     cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.   "
29400|NCT02900833|"     Clinical and experimental data suggest that neutrophil activation and extravasation are     deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome     and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil     recruitment in AIS patients were negative. Recently, an experimental study has shown that     neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of     neutrophil recruitment several hours after the start of ischemia appears therefore too late     to have a clinical relevance.      The objective is to study the time dependent impact of neutrophils in AIS and the predominant     mediators in each time point to identify the appropriate therapeutic target and time window.   "
31067|NCT02879097|"     The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms     of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that     of Avastin® (pharmacokinetics is nested in this study for Indian patients).   "
29384|NCT02901041|"     Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000     deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however,     approved medications for the treatment of AUD has shown limited effectiveness.      Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a     placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism of     action seems to be quite distinct from currently approved anti-alcoholism medications, which     holds promise for treatment of individuals who are not responsive to conventional     medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's     efficacy in treating patients with a diagnosis of AUD.      To fill in these gaps, the investigators will conduct a double-blind randomized controlled     study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol     consumption in patients with AUD. Participants will be randomized to one of two conditions:     1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2)     treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential     therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC     versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as     well as an alcohol related cues task.   "
29385|NCT02901028|"     Significant morbidity, mortality, and related costs are caused by traumatic brain injury     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save     lives, and the huge costs currently being experienced for life-treatment of surviving     victims. An externally-worn medical device that applies mild jugular compression according to     the principle of the Queckenstedt Maneuver. PURPOSE: To monitor changes in vital signs, blood     physiologies, oxygen consumption, biomechanics, strength, neurological capabilities, and     balance in a population of athletes wearing the Device. Secondly, to determine the tolerance     and acceptance of the Device while undergoing exertion.   "
29386|NCT02901015|"     Interventional, multicenter, and longitudinal study, of a cohort of patients with     schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12     months interval.   "
29387|NCT02901002|"     In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are     frequently found. Pain and sensory perturbation seems to modify the way patients perceived     their body part affected.      Does a local body image perturbation can affect the balanced of the global self-awareness?   "
29388|NCT02900989|"     The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions     composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use     of this brief valid screening instrument could assess the risk for suicide in pediatric     patients and then improve the prevention of suicidal tendencies in this population.   "
29389|NCT02900976|"     This pilot clinical trial studies how rituximab and latent membrane protein (LMP)-specific     T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive,     cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder.     Monoclonal antibodies, such as rituximab may block tumor growth in different ways by     targeting certain cells. LMP-specific T-cells are special immune system cells trained to     recognize proteins found on post-transplant lymphoproliferative disorder tumor cells if they     are infected with Epstein-Barr virus. Giving rituximab and LMP-specific T-cells may be better     in treating pediatric organ recipients with post-transplant lymphoproliferative disorder than     rituximab alone.   "
29390|NCT02900963|"     Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or     associated to surgical treatment. Early (during treatment or the following weeks) and late     side effects contribute to malnutrition in this population at risk. In this context,     nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or     gastrostomy) are often necessary. The early identification of the patients with high     malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and     efficacy of treatment. This prospective study research the factors of malnutrition during     head and neck radiotherapy.   "
29391|NCT02900950|"     A single-centre, randomised clinical trial of patients affected by periampullary cancer who     underwent pancreaticoduodenectomies which included two different types of specimen     margination: arm A (multicolour inking) and arm B (monocolour inking). The randomisation of     the specimen was made after the resection, blinded for the surgeons involved in the     operation. The primary endpoint was the overall R1 resection rate and its difference between     the two arms. The secondary endpoints were the R1 resection rate in each margin and its     difference between the two arms, and the impact of margin status on survival. A sample size     of 18 patients was required.   "
29392|NCT02900937|"     The purpose of this study is to evaluate the safety and performance of a new version of a     coronary artery stent for treating blockages in the arteries supplying blood to the heart     muscle. The Amaranth Medical MAGNITUDE scaffold releases a drug (sirolimus) to reduce the     likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold     dissolves away over time, leaving no permanent implant after the blood vessel has healed.   "
29393|NCT02900924|"     The MIMICS-3D study will evaluate safety, effectiveness and device performance within a     real-world clinical population of patients undergoing femoropopliteal intervention.   "
29394|NCT02900911|"     Head and neck cancer has a negative impact in swallowing function and quality of life.     Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies     suggest that interventions should be initiated prior to RT sessions. This study aims to     evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The     study pretends to establish a preventive rehabilitative program with the target of reducing     RT side effects and improve patients' quality of life.   "
29395|NCT02900898|"     Rheumatoid arthritis (RA) is a chronic autoimmune disease with metabolic alterations due     mainly by the liberation of catabolic cytokines leading to changes in body composition as     rheumatoid cachexia. Dynamic exercise (DE) has demonstrated to improve muscular, strength and     joint function as well as inflammatory process. Also, a diet focused on the consumption of     certain fatty acids like the Mediterranean is recommended to reduce inflammation. The aim of     this study is to assess the effect of a dynamic exercise program in combination with a     Mediterranean diet in strength, joint mobility and disease activity in women with RA.   "
29401|NCT02900820|"     There is no evidence that discontinuing antibiotic therapy for non-bacterial infections is     safe. The main objective of this study is to determine whether discontinuation of antibiotic     therapy when a clinician no longer considers it necessary makes any difference in terms of     the number of days with severe symptoms. This is a multicentre, open-label, randomised     controlled clinical trial. The study will be conducted in ten primary care centres in Spain.     We will include patients from 18 to 75 years of age with uncomplicated acute respiratory     tract infections (RTIs) in whom: antibiotics are not necessary; or those diagnosed with     clinical conditions for which antibiotics might be necessary but according to the history and     clinical examination the physician considers that antibiotics are not needed or the patient     feels that the antibiotic regimen has not worked as expected; or several doses of an     antibiotic have been taken from leftovers found in the household or obtained at the pharmacy     without any medical prescription for a clinical condition for which antibiotics are not     necessary. The patients will be randomly assigned to the usual strategy of continuing     antibiotic treatment (usual intervention group) or discontinuing antibiotic therapy (novel     intervention group). A sample size of 215 patients per group was calculated on the basis of a     reduction of one day in the duration of severe symptoms as a clinically relevant outcome. The     primary outcome will be duration of severe symptoms, i.e. symptoms scored 5 or 6 by means of     a symptom diary. Secondary outcomes will include: antibiotics taken, adverse events, patient     satisfaction, and complications within the first 3 months.   "
29402|NCT02900807|"     Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is     intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the     tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the     vocal cords by the balloon. If the tube is inserted too far there is a risk of selective     intubation into the right or left mainstem bronchus, which can lead to contralateral lung     atelectasis and hypoxemia.      The purpose of this study is to determine whether there is a correlation between the     measurement of the airway of an adult population and criteria that would be easily accessible     in daily clinical practice: the height of the patient and the size of their feet.   "
29403|NCT02900794|"     Sinusitis is a common medical problem, which significantly decreases patients' quality of     life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion     and drainage, decreased sense of smell, and malaise. Surgical therapy for sinusitis attempts     to restore the sinus health by directly relieving sinus obstruction. Small telescopes, called     endoscopes, are placed through the nostrils into the nasal cavity to enhance visualization,     illumination, and magnification of the sinuses and adjacent structures. There are a variety     of surgical instruments available to a surgeon for ESS such as stainless steel tools     (shavers, microdebriders, or grasping tools) to address sinusitis. Surgical therapy has been     shown to improve QOL, decrease medication use and days missed at work for subjects. The use     of lasers in treatment of chronic sinus infections is well documented. The LF-40 Gold Laser     (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use in various     procedures including tonsillectomy, adenoidectomy, tracheal stenosis (narrowing),     post-intubation granuloma, recurrent respiratory papilloma, and microtia (an underdeveloped     ear), and sinus surgery. In this study, the investigators plan to utilize the Gold laser for     1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization     of the turbinates and compare postoperative outcomes with the use of a microdebrider. These     uses are under the approved indication for the LF 40 Gold Laser1, 2, 3. The follow-up times     are as follows: 2 weeks postoperatively, 2 months postoperatively, 6 months postoperatively.   "
29404|NCT02900781|"     Partial or Total Knee Arthroplasty are procedures commonly used in severe degeneration of the     knee joint due to osteoarthritis. With an increasing number of Partial or Total Knee     Arthroplasty performed in a population that is aging during a time where the amount of     healthcare dollars allotted to rehabilitation is declining, there is a need to develop remote     monitoring of rehabilitation and to engage and optimize self-management of recovery.      Current management of Partial or Total Knee Arthroplasty recovery is typically performed in     the out-patient setting and is highly protocol driven. A typical case might be seen by the     physical therapist 2-3x/week for 8-10 weeks to perform specific exercises and to monitor     progress (i.e. compliance with ROM and strengthening exercises). One recent study suggested     that variation in patients' independent exercise and activity after arthroplasty surgery may     contribute to variable functional gains.      The investigators are proposing that the StepRite device developed by MedHab, (a shoe insert     that collects functional data) will reduce cost and improve the efficacy of rehabilitation in     total knee arthroplasty patients   "
29405|NCT02900768|"     Although allogeneic haematopoietic stem cell transplant (AlloHSCT) is a curative treatment     option for malignant hematological diseases, it is also associated with significant morbidity     such as graft versus host disease, infections, and immune complications. Moreover, long-term     survivors are likely to have reduced physical performance and functioning due to     deconditioning, sarcopenia, and bone loss, and particularly high levels of fatigue and     psycho-social stress, all of which negatively impact patients' quality of life.      Purpose: To conduct a randomized controlled, single site trial investigating whether a     partially supervised exercise intervention in the first 100 days post alloHSCT patients will     result in improved quality of life at Day 100 post-transplant compared to standard of care     treatment. Secondary objectives will investigate the effect of an exercise intervention on     muscle strength, cardiorespiratory fitness, mobility, bone mineral density, body composition,     exercise, and immunological/inflammatory biomarkers compared to standard of care.      Procedure: 120 patients receiving alloHSCT will be baseline tested, and then randomized into     an Exercise Intervention Group or Standard of Care Control Group.   "
29406|NCT02900755|"     Perampanel, a novel AED, has been recently authorized in Korea and worldwide as a treatment     of refractory partial-onset seizures with a new anti-epileptic mechanism of a selective     non-competitive antagonist of AMPA receptors.      Evaluating adverse effects during the introduction of new AED is often difficult since the     complaints are subjective and objective assessment is complicated due to the polytherapy.     Majority of previous studies are focused on quantitative analysis of EEG for taking new AEDs     because of the correlation of EEG analysis results and side effects of AED such as cognitive     slowing. Therefore, this study aims to investigate the effects of perampanel on EEG in terms     of EEG background spectra and to evaluate perampanel effects by using subjective     questionnaires assessing depression, anxiety, sleep quality and fatigue.   "
29407|NCT02900742|"     The investigators performed a randomized, prospective study method on observation of     Traditional Chinese Medicine(TCM) combined with chemotherapy maintenance to prolong the     efficacy of long-term survival of advanced non small cell lung cancer(NSCLC) patients.The     investigators plan to involve 100 cases for observation in 3 years (50 cases for chemotherapy     maintenance, 50 cases for chemotherapy maintenance plus TCM), expecting that integrated TCM     combined with chemotherapy maintenance has a better efficacy on prolonging progression-free     survival time, overall survival, improving quality of life(QOL) of patients than that of     chemotherapy maintenance.   "
29408|NCT02900729|"     Hypertension represents a significant global public health problem, contributing to vascular     and renal morbidity, cardiovascular mortality, and economic burden. For a mostly asymptomatic     disease, there is a huge challenge to maintain a good adherence and longtime persistence of     drug use so as to adequately control it. Even so, a significant proportion of patients will     develop resistant hypertension. In recent years, renal denervation has been argued as an     effective means to address blood pressure problem in several non-Chinese clinical trials. The     technique is to deliver low level radiofrequency energy through the renal artery wall to     target the sympathetic nervous system and then modulate blood pressure.      Shanghai WiseGain Medical Devices Co., LTD has developed the WiseGo Catheter System, which is     an irrigated radiofrequency ablation Catheter. With this Catheter, it is expected to improve     blood pressure status among patients with resistant hypertension failing polypharmacy. The     purpose of this randomized control trial is to obtain an assessment of the efficacy and     safety of WiseGo renal denervation technique in the presence of three standard     antihypertensive medications in Chinese patients.   "
29409|NCT02900716|"     This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of     an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia     or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in     combination.      This study will be conducted in two parts: phase Ia and Ib. Both parts will explore     escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy.     The phase Ib study will evaluate DTRMWXHS-12 combinations.   "
29410|NCT02900703|"     -  Epidemiological studies have shown the diversity of resistance genotypes and the          evolution of their prevalence in the paediatric population. This large study conducted          in a context of very low vaccination coverage will generate more precise data on the          natural epidemiological evolution of rotavirus, notably the G9 genotype, which has          appeared relatively recently.        -  This study will allow us to identify and document rare or unusual strains of human or          animal origin. The complete genetic characterization of these strains will also make it          possible to study their ability to recombine and to assess the risk of emergence. Among          these still rare strains, the investigators are particularly monitoring G12 rotavirus,          whose ability to recombine raises the risk of emergence.        -  For at least one of the centres taking part in the study, the paediatric population          studied will be given strong vaccination coverage. It will be extremely interesting to          compare the results obtained in the vaccinated population with non-vaccinated children          to assess the impact of this vaccination on the distribution of rotavirus genotypes   "
29411|NCT02900690|"     The main objective of this project is to assess the average cost of the treatment of bleeding     postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference     strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in     some cases very costly invasive procedures. It will be interesting to compare the average     cost of the complete strategies supported.   "
29412|NCT02900677|"     The aims of this three-year study are to:        1. explore the change of fatigue, nutritional status, quality of life and care needs in          patients with operable pancreatic cancer perioperatively and following surgery within 3          months.        2. develop and evaluate the effect of patient-centered cancer prehabilitation care program          on improving fatigue, nutritional status and quality of life (QOL) in this population.   "
29413|NCT02900664|"     The purpose of this study is to combine the PDR001 checkpoint inhibitor with each of four     agents with immunomodulatory activity to identify the doses and schedule for combination     therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical     activity of these combinations.   "
29414|NCT02900651|"     The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or     recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and     pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse     Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors     for whom no further effective standard treatment is available.   "
29415|NCT02900638|"     The purpose of this study is to determine whether mentoring is associated with beneficial     cardiovascular health effects in both mentors and mentees.   "
29416|NCT02900625|"     Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have     to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The     main part of the ovary is preserved, as primordial and primary follicles are resistant to     freezing / thawing protocols. In the absence of other techniques (in vivo maturation,     injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is     currently the only technique allowing fertility to be restored. Autograft is possible only if     the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant     pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies,     particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of     any codified technique for evaluating residual disease (MRD). The team has for two years been     developing and validating a technique to look for residual disease in fragments of ovarian     cortex in cases of acute leukemia. This technique is based on an original protocol for     dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be     analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have     been demonstrated in an experimental model. This model consists in using 8 color flow     cytometry to look for characterizable leukemia cells added in different dilutions to a     population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of     10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR with     the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with     polycystic ovary syndrome. The main objective of this project is to validate techniques that     have been previously codified with different populations of leukemia cells that may be     characterized. The investigators then aim to adapt and validate this technique to look for     MRD using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia     patients that are at risk of metastasis. Secondary objectives will be to implement procedures     for oncological qualification of grafts in cases of malignant pathology and to consider the     recommendations for using this cryopreserved ovarian tissue through the autograft technique     for these indications.   "
29417|NCT02900612|"     This study aims to compare the effects of two water-based training models in physiological     parameters of dyslipidemic elderly women. Thus, a randomized controlled clinical trial will     be conducted in parallel with the participation of 45 dyslipidemic elderly women.   "
29418|NCT02900599|"     Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to     antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use     various psychometric tools to determine if these scores have a predictive value on late     testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The     expected outcomes would be to be able to stratify patients using a behavioural risk score and     allocate targeted ressources to improve the quality of care for the most at risk patients.   "
29419|NCT02900586|"     The purpose of this study is to contribute to the evaluation of SIOUX study by adding data     about the choices of the observant patients, the mis-observant ones or the protocol     deviations.   "
29420|NCT02900573|"     Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical     dilemmas among health care providers, despite clinical guidelines.   "
29421|NCT02900560|"     The purpose of the study is to determine the optimal dose of CC-486 (oral azacitidine) in     combination with pembrolizumab for the treatment of platinum-resistant/refractory Epithelial     Ovarian Cancer (EOC).   "
29422|NCT02900547|"     The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart     Failure will be enrolled and health data will be collected at hospital admission and during     hospital stay. No data will be collected before detailed information is given to the patient     and a non-opposition is obtained.      The aim of this observational and prospective study is to evaluate the concordance actual     patient management during the in hospital treatment of heart failure and the therapeutic     proposals from a medical algorithmic decision support software.   "
29423|NCT02900534|"     The purpose of this study is to evaluate the efficacy of an internet-based self-help     intervention for older adults with prolonged grief symptoms after spousal bereavement or     separation/divorce. The study design is a randomized trial with a waiting control condition     of 12 weeks and a follow-up after 6 months. The investigators will test the following main     hypotheses:        1. The intervention group shows a significant decrease in grief symptoms, psychological          distress, depression symptoms and embitterment, and a significant increase in life          satisfaction, as well as session related outcomes from baseline to 12 weeks post          intervention assessment.        2. The effects in the intervention group are larger than the effects in the waiting control          group.        3. These effects are stable from the post measure at 12 weeks to the 6-month follow-up.   "
29424|NCT02900521|"     The registry is the main objective exhaustive list of cases validated stroke brain on a     geographical area defined to calculate an incidence.   "
29425|NCT02900508|"     The purpose of this study was to investigate the effects of virtual reality-base training for     cerebellar ataxia.   "
29426|NCT02900495|"     Children referred to the pediatric urology clinic for primary nocturnal enuresis will be     screened for enrollment. Patients who fail behavioral therapy and who meet inclusion criteria     will be offered therapy with a TENS unit.      Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation     arm with electrodes placed onto the abdomen in the suprapubic region directly over the     bladder. Group 2 will be the distal neural loop arm with electrodes placed over the posterior     tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3     cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the     control arm with electrodes placed on the scapula. We will aim to recruit 32 patients per     group for a total of 128 patients. The patients will be provided with a TENS unit (TENS 3000     Analog) and electrode pads and caretakers instructed on how to use the apparatus.      The TENS sessions will be performed nightly before bed for 20 minutes. TENS units will be set     at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the     patient. Diaries including nighttime incontinence episodes and a wet sheet scale (dry,     damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit.     Patients will be followed up after one month of TENS with evaluation including the Pediatric     Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in     children with bladder dysfunction; this questionnaire will be filled out prior to starting     TENS treatment in order to compare the effect of treatment on QOL. . They will then follow up     on these parameters again after another month (one month off of TENS therapy) to assess the     durability of treatment effect. The data will be collected at different time points     (baseline, 1 month, 2 months) for each group by itself and the groups compared against each     other using statistical analysis.   "
29427|NCT02900482|"     The main objective is to identify the genes involved in congenital dislocation of the hip.      The secondary objectives are to measure the association between mechanical risk factors and     congenital dislocation of hip and study the interactions between these factors and genetic     factors.   "
29428|NCT02900469|"     The purpose of this study is to determine whether one dose of denosumab can lead to changes     in the tumor, which may decrease the ability of tumor to spread.   "
29429|NCT02900456|"     Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units,     Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in     patients in cardiogenic shock (CS) or at high risk situation as mechanical complications     stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc.     Several papers recently questioned the relevance of this assistance device - namely the     IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in     the downgrading of the recommendation standards of the IABP by medical societies.   "
29430|NCT02900443|"     Rationale: Current standard therapy of autoimmune hepatitis consists of a combination of     prednisolone and azathioprine. However, a significant proportion of patients does not respond     to, or is intolerant for, azathioprine. Mycophenolate mofetil (MMF) has surpassed     azathioprine as therapy to prevent organ transplant rejection and is sometimes used as an     alternative option for autoimmune hepatitis. Several case series and one prospective study     have documented the efficacy and safety of mycophenolate mofetil as induction therapy for     autoimmune hepatitis. Robust evidence from a formal randomized clinical trial is lacking.      Objective: To assess the efficacy and safety of mycophenolate mofetil as induction therapy in     patients with treatment naive autoimmune hepatitis.      Study design: Multicenter, randomised, open-label intervention study Study population:     Patients with newly diagnosed autoimmune hepatitis who are in need of induction therapy     according to current guidelines.      Intervention: The intervention group will receive oral mycophenolate mofetil for 24 weeks.     The control group will be treated with azathioprine for 24 weeks. Both groups will be treated     with steroid induction which will closely follow the schedule from the recent Clinical     Practice Guidelines by the European Association for Study of the Liver (EASL).      Main study parameters/endpoints: The primary outcome is the proportion of patients in     remission, defined as normalization of serum alanine transaminase (ALT) and immunoglobulin G     (IgG) levels after 24 weeks of treatment, per treatment group. Secondary endpoints include     safety and tolerability of mycophenolate mofetil, time to remission, changes in Model For     End-Stage Liver Disease (MELD) -score (and its components bilirubin, INR, creatinine),     albumin, pseudocholinesterase and N-terminal procollagen-III-peptide, ELF (Enhanced Liver     Fibrosis) -score and aspects of quality of life. In a sub-study, drug levels will be     measured.   "
29431|NCT02900430|"     Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose     invasive aspergillosis (IA). These infections are leading to an important morbidity and     mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during     neutropenia induced by induction chemotherapy. Their application is not uniform.   "
29434|NCT02900391|"     Elderly population is increasing quickly and their need for health care ressources through     emergency care is also growing. While these patients are ageing physical impairment often     happens along the way. Apart from senior homes, different types and levels of home care     services have been developped in order to overcome or to adapt to these situations.      Our goals are:        -  to assess mortality rate depending on home care services level for the elderly          population consulting in the ED or being taken in charge by the Emergency Medical System          in France.        -  to describe this population in terms of autonomy, impairment and home care services   "
29435|NCT02900378|"     The purpose of this randomized, actively controlled, double-blind study is to demonstrate the     superiority of sacubitril/valsartan over enalapril in increasing non-sedentary physical     activity chronic heart failure patients with reduced ejection fraction. Physical activity     will be continuously measured by means of a wrist-worn accelerometry device from 2 weeks     before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).   "
29436|NCT02900365|"     In a randomized clinical trial, 30 eyes with traumatic cataract after open globe injury with     IOL implantation underwent early and 30 eyes underwent late cataract surgery. We excluded     patients who were under 12-year-old. All patients were visited at 1week, 4 weeks , 12 weeks     and six months after surgery. In each visit, patients were examined regarding visual acuity,     intraocular pressure (IOP), anterior chamber inflammation, IOL position and posterior     synechiae. In addition, posterior segment evaluation and funduscopy were performed.     Intraoperative complication including posterior capsular rupture, anterior vitrectomy and     zonulysis as well as the site of IOL implantation were documented and postoperative     complications including raised IOP, anterior chamber inflammation, visual axis opacity,     posterior synechiae, subluxation of IOL, IOL pigment deposition were listed.   "
29437|NCT02900352|"     This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication     zonisamide for the treatment of heavy drinking alcoholic civilians.   "
29438|NCT02900339|"     Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging     modality. Today it is considered an anatomical and functional exploration reference     technique. Since its inception around 1985, this technology is constantly evolving.      Many advances in MRI require constant adaptations of radiological practices. The     morphological image is now associated with functional and parametric information (infusion,     diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing     of data also open new applications (tractography, functional MRI, etc ....). Thus, more and     more procedures are necessary to integrate these techniques for the diagnosis and adapt to     new demands of clinicians.      The type of sequence and its associated parameters allow to directly influence the contrast     of images, to characterize tissue compared to another and, ultimately, to highlight     morphological or functional abnormality. Image quality can be optimized on each MRI,     depending on the time available for the acquisition on the one hand, and on the desired     resolution and contrast, on the other hand. For each sequence, it is therefore necessary to     find a compromise that will optimize the diagnostic quality of the examination.      This optimization requires a phase focusing on healthy volunteers. It is therefore important     that researchers and physicists could design on healthy volunteers, the best settings of all     parameters for an image or spectrum. Indeed, it is always necessary to properly optimize     every parameter choices before beginning a study of a cohort of patients.      In this context, the main objective of this study is to optimize sequences and imaging     protocols to evaluate and validate the choice of parameters in healthy volunteers.   "
29439|NCT02900326|"     Integrative approaches to promote wellness and reduce the distress associated with cancer are     considered as essential components of cancer care. In case, exercise training has been shown     to produce many positive physiological and psychological benefits. Mindfulness-based stress     reduction program shows similar beneficial effects, and especially in emotional distress     management. The aim of the study is to examine the cumulative effect of an 8     week-exercise-training program combined with an MBSR program on cardio-respiratory fitness     and quality of life in women with breast cancer. These effects are thought to be mediated in     part through changes in underlying brain processes, that investigators will be put in light.     Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine     level measurements, investigators could expect to better understand the effect of these     combined training in breast cancer.   "
29440|NCT02900313|"     Cardiac surgery associated acute kidney injury is an independant factor of morbidity and     mortality . Despite its delayed elavation, serum creatinine (Cr) remains the goal standard to     diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion     decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its     variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of     renal function in this context. Consequently, the purpose of this study is to evaluate the     predictibilty of Ph to detect both AKI induction and in a second time, renal recovery.   "
29441|NCT02900300|"     The first aim of the study is to obtain from chirurgical micro biopsy myoblast in culture     which will differentiate in Diaphragm fiber. Then these fibers will be submitted under     mechanical stress condition similar to those imposed in vivo by mechanical ventilation to     validate in human a model in vitro of diaphragm dysfunction induced by mechanical     ventilation. Then the second part of the study will be to evaluate with this model, the     efficiency of an antioxidant therapy.   "
29442|NCT02900287|"     Cancer survival is important to determine prognostic of patients and evaluate care and     prevention health strategies. Sucre is the first study to describe cancer survival in Reunion     Island. Sucre aims at evaluating five year cancer prognostic in Reunion Island by cancer site     and gender. Sucre is a retrospective cohort study of cancer diagnosed between 01/01/1998 and     31/12/2008.   "
29443|NCT02900274|"     The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent     system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis     post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA)     and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2     & P3)   "
29444|NCT02900261|"     This study will compare different methods (24 hour urine collection, evening and morning     spots, and questionnaires) to measure the consumption of sodium and cafeine in children and     adolescents.   "
29445|NCT02900248|"     Registry participants with advanced malignancy or myelodysplasia will have a sample of their     tumor or tissue analysed for genetic alterations using next generation sequencing (NGS)     performed in a lab that has been certified to meet a high quality standard. Treatments and     outcomes will be reported to the registry to allow further understanding of how genetic     differences can lead to better diagnosis and treatments.   "
29446|NCT02900235|"     The purpose of this study is to investigate the absorption, metabolism and excretion of     MT-3995 in healthy subjects.   "
29447|NCT02900222|"     The purpose of this study is to determine whether endoscopic choroid plexus coagulation is     safe in adult patients with communicating hydrocephalus and risk factors for complications     from the standard surgical treatment. It may also help determine whether the endoscopic     choroid plexus coagulation is effective in treating your communicating hydrocephalus. The     Investigators hope that this research will allow us to place fewer shunts in patients with     conditions similar to yours, avoiding complications.   "
29448|NCT02900209|"     The aim of this study is to determine responses of the immune system to the annual flu     vaccination in people with COPD who experience frequent or infrequent exacerbations and     healthy participants. We will collect blood and saliva immediately before and one month after     flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly     antibodies (that provide protection against infection) develop in the blood after vaccination     we can provide important new information to help confirm whether those prone to COPD flare     ups have weaker immune systems.   "
29449|NCT02900196|"     The purpose of this clinical study is to evaluate the effect of a four-week consumption of a     fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea     and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori     eradication.   "
29450|NCT02900183|"     Patients with Alpha-1 Antitrypsin Deficiency (AATD) will be enrolled to receive multiple     doses of ARC-AAT Injection. All subjects will require a pre-dose biopsy and a biopsy post     last dose.   "
29451|NCT02900170|"     Anticoagulation-Related Nephropathy (ARN) is a side effect of treatment with blood thinners     which leads to kidney dysfunction. A recent review suggests that kidney function should be     assessed (by measuring serum creatinine) serially in the first few months of starting a blood     thinner. ARN is diagnosed when there is a decline in kidney function after starting the blood     thinner and other possible causes of this decline have been excluded. ARN has mainly been     studied in relation to the common blood thinner - warfarin, where the prevalence is variable     but can be as high as 37% (approximately 1 in 3) in the patients at highest risk. The risk     factors that make this side effect more likely include the presence of pre-existing kidney     disease, high blood pressure, older age and diabetes mellitus. Studies have shown that the     occurence of ARN can lead to an accelerated progression of pre-existing kidney disease and a     65% increase in the risk of death (mortality).      The non-vitamin K oral anticoagulants (NOACs) are a new group of drugs which have been     recently approved for use as blood thinners. They have a faster onset of action compared to     warfarin and unlike warfarin, they do not need frequent monitoring. Rivaroxaban is the most     commonly prescribed NOAC at Einstein Medical Center Philadelphia. There are some case reports     that other NOACs (such as dabigatran and apixaban) can lead to ARN, however there is no study     that has determined the true incidence of ARN in NOACs. Our study is designed to find out the     incidence of ARN in patients who are started on rivaroxaban.      The investigators intend to serially monitor the kidney function of 40 high risk patients who     are recently started on rivaroxaban over a six month period. This will enable us to discover     how many patients actually develop ARN after starting a NOAC. The information the     investigators will obtain from this study will enable patients and health care providers make     better decisions about using blood thinners. If the investigators find that the incidence of     ARN with rivaroxaban is less common than that previously reported with warfarin, it can     potentially make more patients use the NOACs and hence save them from the morbidity and     mortality associated with ARN. Our study is unique because this will be the first study     focused on ARN in one of the new blood thinners. The information the investigators get from     this study will be a very important foundation for future studies.   "
29452|NCT02900157|"     This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK,     immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid     tumors.   "
29453|NCT02900144|"     The main purpose of this trial is to develop and investigate the effects of a modified     comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents     with chronic tic disorders and ADHD.      CBIT is a first-line behavioral treatment for individuals with tic disorders. However, the     benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively     associated with effect size in behavioral treatments for tics. Additionally, while tic     disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.'     Despite improving tics, measures do not show associated improved quality of life. Currently,     there are no standardized behavioral treatments for tics that account for ADHD symptoms     and/or addresses the impact that tics and ADHD symptoms have on quality of life.      The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive     Behavioral Therapy (CBT) for ADHD and factors targeting psychosocial impairment.      The second aim is to determine the treatment feasibility and acceptability (e.g. retention,     reasons for treatment refusal and dropout, and motivation) of this modified CBIT treatment.     The investigators will evaluate and assess the randomization process, the treatment modules,     and the expectations and satisfaction of the participants and their parents.      The final aim is to use a pilot randomized control trial (RCT) design to evaluate improvement     using measures including tic, ADHD and quality of life scales as rated by a blinded     clinician. Though the investigators will evaluate efficacy of the modified protocol, the     primary purpose will remain feasibility. The hope is to use this study to develop larger     trials in the future.   "
29454|NCT02900131|"     Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence.     Complementary and alternative medical approaches have been employed to relieve symptoms of     Atopic Dermatitis. We aim to establish basic clinical efficacy and safety data for Jaungo in     patients with Atopic Dermatitis.   "
29455|NCT02900118|"     Breast cancers are among the cancers that metastasize the most to the skeleton. The     appearance of bone metastasis, whether they are initials or during a relapse, is a turning     point of the disease, due to the additional morbidity they imply (pain, pathologic fractures,     hypercalcaemia, neurological compression, etc.). A specific treatment of these metastasis is     often undertaken, usually a chemotherapy or hormone therapy. It is important to evaluate the     efficacy of this treatment in order to know whether to continue or change it depending on the     response observed. But there is no consensus at this time on paraclinical examinations     enabling this monitoring. Also, if some criteria for assessing bone metastasis in imaging and     nuclear medicine (MDA, PERCIST, EORTC) have been published in the literature, none is     formally validated and evaluation in routine practice remains subjective.      The main objective of our study is to determine if the PET-CT and the whole-body MRI are in     agreement on the status of bone metastasis (stability, progression, partial response,     complete response).   "
29456|NCT02900105|"     The investigators hope to learn if Letrozole is effective and safe in improving severe male     infertility by increasing testosterone, decreasing oestradiol and stimulating sperm     production thereby improving sperm motility (movement) and concentration. The study is being     conducted because Letrozole is not yet proven to be a standard treatment in subjects with     absent or very low sperm counts. The investigators are hoping to determine whether Letrozole     is equal or superior to no treatment.   "
29457|NCT02900092|"     Major depressive disorder (MDD) is highly prevalent and nearly 70% of individuals with MDD do     not respond to standard antidepressant therapies despite adequate dosing. An effective and     well-tolerated antidepressant augmentation therapy would have important clinical and public     health implications. Neuroactive steroid hormones are known to directly activate     neurotransmitter receptors in the brain, and thus are potential candidates for augmentation     therapies to enhance the effect of traditional antidepressants. The investigators hypothesize     that administration of an allopregnanolone analog in women with treatment-resistant     depression will improve depressive symptoms.   "
29458|NCT02900079|"     This study is part of a larger prospective cohort study (JOKA), designed to study the     incidence and etiological spectrum of febrile illness occurring during a travel to the     tropics, as well as clinical course, care, treatment and outcome of these febrile illness     episodes. Its objective is to evaluate the clinical use of malaria rapid diagnostic tests     (RDT) by travelers or their peers during travel, as a decision aid for the management of     febrile illness in the tropics.      If the study demonstrates that malaria can be ruled out safely by travelers themselves using     a RDT, a combination of self/peer testing with SBET may become an alternative to antimalarial     chemoprophylaxis in travel medicine.   "
29459|NCT02900066|"     This study is part of a larger prospective cohort study (JOKA), designed to study febrile     illness occurring during a travel to the tropics, as well as the evaluation of the clinical     use of malaria rapid diagnostic tests (RDT) by travelers or their peers during travel, as a     decision aid for the management of febrile illness in the tropics.      Filter paper blood spots and paired serology are used in addition to routine post-travel     evaluation, to study the incidence and etiological spectrum of febrile illness occurring     during travel to the tropics.      The study will yield valuable and prospective data of incidence rate, the clinical and     etiological spectrum, clinical course and outcome of febrile illness during (and post-)travel     in a prospective cohorts of travelers. This knowledge may lead to better pre-travel advice.   "
29460|NCT02900053|"     Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure     to a terrifying event or ordeal in which there was the potential for or actual occurrence of     grave physical harm. Traumatic events that may trigger PTSD include violent personal     assaults, natural or human-caused disasters, accidents, and military combat. People with PTSD     have persistent frightening thoughts and memories of their ordeal, may experience sleep     problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite     high, with 7-8% in various studies and 4% in french studies.      The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake     inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to     trauma-linked elements (memories, feelings and thoughts) so the fear associated to the     traumatic event can decrease. But the therapeutic response stays partial, even combining     these treatments.      To improve the PTSD treatment efficiency, innovative approaches are being explored like new     drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but     promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation     (tDCS) to enhance the trauma-focused therapy results.   "
29461|NCT02900040|"     The French DIVAT (standing for Données Informatisées et VAlidées en Transplantation in     french, and in English Computerized and VAlidated Data in Transplantation ) cohort was     Kicked off in 1994 by the Transplantation Urology Nephrology Institute of the Nantes     University Hospital in France. The primary objective of this multicenter computerized     database was to enable prospective clinical and epidemiological research studies concerning     kidney transplant recipients, particularly focusing on mid- and long-term clinical outcomes,     therapeutic strategies and public health issues. The patient-case system of the DIVAT cohort     allows the monitoring of medical records of all patient-specific and allograft-specific data,     including bio-banking since 2005. Data are collected from the date of transplantation until     the graft failure, at each scheduled outpatient visit or hospital admission motivating by a     new clinical, therapeutical or biological expression. The DIVAT cohort contains information     on more than 11000 transplant recipients between 1994 and today, issued from 8 French     university hospitals centers (the DIVAT Network is organized by a consortium agreement). 18%     of all patients underwent retransplantation and 11% of all kidney transplants originated from     living donors. The DIVAT network heavily works to ensure a high-quality data collection with     the aim of exploring adequately the complex post-transplantation process. The Divat network     encourage collaborations and enables interested researchers to submit a research project by     completing a request form available on the DIVAT website (http://www.divat.fr/en) describing     the context, objectives and design of the study   "
29462|NCT02900027|"     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     IONIS APOC-III-LRx given to healthy volunteer subjects.   "
29472|NCT02899897|"     IV fluid therapy remains an essential haemodynamic objective in the treatment strategy of     septic shock. Left ventricular systolic dysfunction secondary to sepsis is observed in 40%     and up to 65% of the population concerned. However, the capacity of the various indices to     predict the response to IV fluid therapy in septic shock with left ventricular systolic     dysfunction have not been clearly defined. Measurement of parameters reflecting filling     pressures during transthoracic echocardiography (TTE) is one of the methods used to evaluate     cardiac function and estimate the filling reserve, but with no strong evidence. Right heart     catheterization with determination of cardiac output by pulmonary thermodilution can also be     used to measure the various parameters commonly used to predict the response to IV fluid     therapy. Very few data are available with no reliable and clinically relevant data in this     population with septic shock and left ventricular systolic dysfunction (LVEF ≤ 40%) and the     response to IV fluid therapy monitored by dynamic indices obtained by transpulmonary     thermodilution and right heart catheterization. Consequently, the capacity of the various     indices of preload dependence to predict the response to IV fluid therapy in septic shock     with left ventricular systolic dysfunction remains difficult to define.   "
29463|NCT02900014|"     Cell therapy appears to be an alternative to treat bone defects. Scientific advances have     shown in animal models and in humans that mesenchymal stem cells were good candidates to     support cellular bone regeneration after transplantation. However, their collection requires     invasive sampling usually bone marrow. A new candidate stem cells able to stimulate bone     regeneration has recently been identified in the nasal cavity, these cells are called     ecto-mesenchymal cells. These stem cells have very similar biological characteristics of     mesenchymal stem cells of bone marrow. They exhibit a high mitogenic activity and hold great     potential for differentiation into osteoblast lineage. Given their properties and their ease     of access within the nasal cavity, ecto-mesenchymal stem cells offer new prospects for cell     therapy targeting bone involvement. In this context, the ecto-mesenchymal stem cells     represent a nasal bone reconstruction interesting alternative in particular in indication of     the cleft. They are directly and easily accessible in these children when conventional     surgical reconstruction. The investigators propose in this study to validate a production     method of stem cell called ecto-mesenchymal isolated from a biopsy of the nasal cavity of     children with cleft lip and palate to be able to soon propose cell therapy innovative in this     indication.   "
29464|NCT02900001|"     This study is to evaluate the efficacy and safety of early invasive strategy and routine     delayed invasive strategy in Chinese elderly patients of 75 years or older with non-ST     elevation myocardial infarction, and to verify the hypothesis that routine delayed invasive     strategy is inferior to early invasive strategy in such a group of patients.   "
29465|NCT02899988|"     The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in     participants with moderate to severe plaque psoriasis.   "
29466|NCT02899975|"     The objective of this study is to validate the prototype of the WeTakeCare- system in the     real environment (=end users homes) and is embedded in Work-Package 4 (validation and     evaluation) with the following main tasks:      T4.1. Definition of methodologies and protocols T4.2. First validation: concept assessment     T4.3. Second validation: functional assessment T4.4. Third validation: real environment T4.5.     Final check      Within the validation phase III of our project the investigators want to validate the     contents of our fitness and information software WeTakeCare with the target group: elderly     and their unprofessional caregivers. It runs on the Microsoft Kinect-System, which is     authorised in Switzerland, and is in accordance with the prescribing information. The     fitness- and information software contains information about strategies and devices which are     available in case an older person is not able to perform the everyday movements in a safe and     easy way.      Aim of the training and information software is to support elderly to stay independent from     others help as long as possible. The mentioned software is not a medical or therapeutical     treatment or a medical or therapeutical product. Performed exercises or presented information     are highly regarded in the interest of safety and protection of the participants, and serves     to prevent physical restrictions or damage .      There is only minimal risk or burden for the participants; the contents of the intervention     itself (training of basic motor skills, instruction of strategies and the use of assistive     devices to (partly) compensate restrictions in ADL performance, enablement of caregivers) are     a standard in rehabilitation of elderly.      The investigators expect the start of the third validation in October 2015.   "
29467|NCT02899962|"     A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol     foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis     vulgaris.      A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm,     parallel group trial.   "
29468|NCT02899949|"     Real-world data can supplement the knowledge gained from traditional randomized controlled     trials. To date, only a couple of studies (Andrew et al. 2014 and Wilding et al. 2015) have     been conducted assessing the use of dapagliflozin in the real-world clinical settings in the     United Kingdom and no research has been done on the use of dapagliflozin in Canadian clinical     practice settings.      To the investigators' knowledge, no real-world study exits assessing the impact of using     dapagliflozin in conjunction with insulin in people with type 2 diabetes mellitus on dosage     and frequency of insulin, oral antiglycemic agents and hypertension drugs. This study will     use an electronic medical record-based data that contains demographic, drug coverage, vitals,     lab results, medical problems and diabetes-related complications, and medication prescription     information of patients with diabetes received care from all outpatient diabetes clinics in     London Ontario, Canada to assess the impact of using dapagliflozin in conjunction with     insulin in patients with type 2 diabetes mellitus on health outcomes, and medications dosing     and frequency.   "
29469|NCT02899936|"     The DOLF Triple Drug Therapy for Lymphatic Filariasis study will determine the frequency,     type and severity of adverse events following triple-drug therapy (IVM+DEC+ALB, IDA) compared     to the standard two-drug treatment (DEC+ALB, DA) in infected and uninfected individuals in a     community in 5 different countries. The objective is to acquire safety, efficacy, and     acceptability data to assess the safety and acceptability of the IDA drug combination.   "
29470|NCT02899923|"     Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked     by the production of autoantibodies against the dermal-epidermal junction or against the     inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal     blisters.      The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological     findings, including skin direct immunofluorescence.      Systemic corticosteroid therapy is generally considered as the mainstay of treatment for many     years both for bullous pemphigoid and pemphigus which are the most frequent diseases.   "
29471|NCT02899910|"     The purpose of this study is to measure the metabolic and behavioral effects of a 12-week     yoga program coupled to health education (HED) compared to HED alone.   "
29473|NCT02899884|"     The purpose of this study is to determine the prevalence of breakthrough cancer pain and     characterize breakthrough cancer pain in an unselected, representative cohort of cancer     outpatients with or without pain who attend consultations.   "
29474|NCT02899871|"     IBD (inflammatory bowel disease) are associated with various types of joint manifestations,     especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint     symptoms, with variable expressions and aetiologies, possibly responsible for impaired     quality of life, and possibly leading to discontinuation of an effective and validated     treatment.   "
29475|NCT02899858|"     Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand     and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years,     clinicians have tried to reengage such these circuits for standing and walking in the lower     spinal cord of paralyzed humans through novel paradigms of physical therapy, pharmacological     stimulation of the spinal cord, or recently - epidural stimulation of the spinal cord.     Although standing and stepping with these maneuvers are rudimentary at best, these human     studies offer promise to restore controlled, lower extremity movement to the spinal cord     injured (SCI) individual. Evidence from animal data suggests that more focal activation of     intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce more fatigue     resistant, natural standing and stepping activity in humans. To date, there has been no     direct confirmation of such circuitry in the spinal cord of bipedal humans who have been     paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel     intraspinal neuroprosthetic that should be able to restore control of standing or walking in     a manner that is much more physiologically normal and tolerable than by stimulating each     individual muscle group. Proof of the existence of these spinal circuits in man, and the     ability to activate and control these circuits by first mapping the spinal cord is the basis     of this proposal.   "
29476|NCT02899845|"     This project aims to study the effect of haptic sensory information delivered at the hand     using a cane in light touch or light support condition on postural stability and spatial     and temporal gait parameters of elderly subjects with and without walking difficulties   "
29477|NCT02899832|"     This study will included 20 children presenting with epilepsy with spasms. It aims to offer     these children, non invasively and without supplementary examinations, a recording of local     and cerebral hemodynamic changes concomitant with an electroencephalographic recording during     epileptic episodes. This will be carried out by combining optical imaging using near     infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous     high-resolution (HR) recording.      This study is among those based on multimodal analyses of epilepsy, combining methods of     analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).      Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal     dysfunction from a functional point view. It is used in the routine follow-up of children     with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the     spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non     invasive, and inoffensive which could easily be used at the child's bedside or in a clinical     setting and can provide metabolic information about cerebral function.      This study is multidisciplinary, which calls upon the skills of neurophysiologists,     biophysicists, and clinicians   "
29478|NCT02899819|"     The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie     region to commonly used pesticides. These pesticides were selected in a pilot study (the     Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine     perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators     of pesticide use and the presence of pesticide in the environment in Picardie.      These substances (or their metabolites) will be measured in the each newborn's meconium (the     first faeces after birth) and each newborn's mother's hair in the Picardie region during the     study period. The mother's exposure will also be assessed using a retrospective questionnaire     (filled out within a few days of the delivery).      Thus, the MecoExpo project will enable the investigators to:        1. evaluate the relationships between foetal exposure (via the meconium), maternal exposure          (via the hair and the questionnaire) and clinical parameters measured at birth (term,          length, weight, etc.).        2. map pesticide exposure across the Picardie region.        3. create a meconium bank in Picardie (the first ever meconium bank in France).   "
29479|NCT02899806|"     The aim of this study was to investigate the impact of multimedia information on epidural     anesthesia. Pregnant women were randomly assessed to get a video information in addition to     an oral and written information on epidural anesthesia. Maternal satisfaction concerning the     quality of the information as well their anxiety and understanding of the procedure were     assessed and compared in both groups.   "
29480|NCT02899793|"     Primary Objectives: To assess the antitumor activity (proportion of objective response by     RECIST 1.1 criteria) of pembrolizumab with objective tumor response in patients with     persistent, recurrent or metastatic endometrial cancer harboring an ultra-mutated or     hyper-mutated (MMR gene-defective) phenotype identified by next generation sequencing (NGS)     and comprehensive genomic profiling (CGP). To determine the nature and degree of toxicity of     pembrolizumab as assessed by CTCAE in patients with persistent, recurrent or metastatic     endometrial carcinoma. Secondary Objective(s): To estimate the duration of progression-free     survival (PFS) and overall survival (OS).   "
29481|NCT02899780|"     This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light     for reducing viable bacteria within indwelling tunneled dialysis catheters.   "
29494|NCT02899598|"     Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization     against fetal platelet antigens with paternal origin not present in the mother. It is     considered the equivalent of hemolytic disease of the newborn. The incidence of this disease     is about 1 in 800-1000 births. The most severe forms associated petechiae, purpura or     cephalhematoma at birth with a major risk of cerebral hemorrhages (20% to 25% of cases) can     cause the death of the child (15%) or severe neurological troubles (15-30%) Biologic     diagnosis requires the detection of anti-platelet antibodies with maternal determination of     platelet phenotypes and genotypes of the two parents.      The objective of this work is to develop specific molecular tools to fetal platelet     genotyping from maternal blood. We are particularly interested to antigens HPA-1, HPA-5 ,     HPA-3 and HPA-4. We evaluate the sensitivity and specificity of this test by comparing these     results with those obtained from an invasive sampling of amniotic fluid.      This is a prospective study to assess the technical and diagnostic performance of a new     molecular method noninvasive prenatal diagnosis of platelet genotyping.   "
29495|NCT02899585|"     The aim of the research is to detect prematurely vulnerable patients needing a global     coverage in integrated care with a created and metrological validated score.   "
31155|NCT02877953|"     The investigators conducted a randomized controlled trial to describe if multidisciplinary     and patient-centered transitional care interventions for patients with cirrhosis post-TIPS     can improve compliance behavior and reduce complications post-TIPS after discharge.   "
29482|NCT02899767|"     Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an     uncontrolled proliferation of immature hematopoietic cells. Over the last two decades,     clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive     induction plus more potent intensification programs with chemotherapy alone or chemotherapy     plus stem cell transplantation (SCT) has improved treatment results. Advances in     understanding disease biology, improvements in induction and consolidation program, and     better supportive care have also all contributed. A number of clinical and laboratory     characteristics influence the response to treatment and, thus, the survival of patients with     AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable.     However, other factors may have a prognostic value and may influence patient's outcome.      Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it     has become apparent that the frequency of allogeneic blood transfusions can modify host     immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic     factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood     cell (RBC) transfusion need was identified as a strong and independent risk factor for     survival in MDS, for which the presence and severity of anaemia were attributed to a clonally     advanced and biologically more aggressive disease.      Based on these data, we retrospectively assessed the prognostic value of RBC and platelet     transfusions at the time of diagnosis and the frequency of transfusions during the first     induction course of chemotherapy in a large unselected group of patients with previously     untreated AML.   "
29483|NCT02899754|"     Veterans have a high risk of developing lung in comparison to general populations due to     their older age and smoking history. Recent evidence indicates that lung cancer screening     with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the     rates of false positive findings are high, requiring further testing and evaluation.     Preliminary studies report that while some Veterans are enthusiastic about screening, others     are highly reluctant. Patient preferences should be considered as part of an informed     decision making process for this emerging paradigm of lung cancer control. Effective methods     for preference assessment among Veterans have not yet been developed, evaluated, and     integrated into clinical practice. The specific aims of this study are to 1) elicit patient     and provider stakeholder input to inform the development of a lung cancer screening decision     tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that     incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool     compared to usual care on the decision process, clinical outcomes, and quality of life.   "
29484|NCT02899741|"     The purpose of this study is to determine whether omega-3 is effective in the treatment of     medically intractable epilepsy as adjunctive therapy.   "
29485|NCT02899728|"     This randomized phase II trial studies how well olaparib, cediranib maleate, and standard     chemotherapy work in treating patients with small cell lung cancer. Drugs used in     chemotherapy, such as carboplatin, cisplatin, and etoposide, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Olaparib and cediranib maleate may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate,     and standard chemotherapy may work better in treating patients with small cell lung cancer.   "
29486|NCT02899702|"     IGHN2 is an international, multicenter, double blind, randomized controlled trial aimed at     assessing the efficacy on organ dysfunctions of Intravenous Immunoglobulins (IVIG) treatment     in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.   "
29487|NCT02899689|"     Women undergoing mechanical cervical ripening for labor induction will be randomized to     Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators     (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.   "
29488|NCT02899676|"     The aim of this study was to identify neural correlates involved in arthmetics processing in     adults and children aged 8 to 14 with normal cognitive function. Brain area will be     identified by functional magnetic resonance imaging (IRMf).   "
29489|NCT02899663|"     Systematic retrospective medical chart and medical imaging file review of all patients     receiving brain MRI for the follow-up of glioblastoma.   "
29490|NCT02899650|"     The purpose of this study to determine if older adults who are healthy and physically active     (i.e., Masters athletes) demonstrate slower rates of recovery from unaccustomed strenuous     exercise of downhill running than younger peers.   "
29491|NCT02899637|"     The main objective is to conduct a study protocol to investigate the effects of repetitive     Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals with     incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial of     patients with iSCI will be conducted.   "
29492|NCT02899624|"     Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined     by the presence of two sigmoid valves instead of three. It is conventionally associated with     histological abnormalities of the wall of the ascending aorta, risk factors of aortic     dystrophy observed in 50% of cases, and dissection. Long considered an accident of     development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and     aortic dystrophy suggests the existence of a genetic predisposition and a common genetic     origin for these two pathologies.      Data on the genetic basis of the BAV are still limited, but the existence of a large     phenotypic diversity suggests the involvement of other genes. The establishment of large     collections of DNA will allow great advances in this field.      The purpose of this project is to confirm the existence of a genetic determinism at the     origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying     genetic defects associated with the presence of a BAV in a series of candidate genes.   "
29493|NCT02899611|"     Patients with medically refractory epilepsy will be treated by intracerebroventricular (ICV)     delivery of valproate using an implantable drug pump system. The dose of valproate will be     escalated weekly during a blinded-evaluation period through Day 64 to determine the maximum     tolerated dose (MTD). After Day 64, patients can continue for 52 weeks in the open-label     evaluation period (non-blinded).   "
29540|NCT02899000|"     Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral     Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules     or cysts (non-nodulocystic) during a 12-week treatment period.   "
29496|NCT02899572|"     Erection disorders constitute the first sign of vascular injury in type 2 diabetes patients.     The important frequency of these disorders and their consequences in term of quality of life     have a strong contrast with the actual interest showed for them by the medical community.      Natural evolution of the disease and its management make that these disorders often occur     little time after a therapeutic change. As a consequence, patients often accuse their     medication to be responsible for the appearance of these disorders. This confusion,     associated to false believes that may have the patients on their disease or their treatment,     often leads to treatment discontinuation which has a deleterious effect on the disease     evolution.      Educational therapy programs showed a positive impact on therapeutic adherence. Increasing     patients' knowledge on their disease and treatments increases their therapeutic adherence and     makes it easier to balance diabetes and therefore limits complications appearance.      Educational therapy programs concern today the disease, its process, its evolution, its     treatments, their efficacy, their adverse effects but erection disorders are not specifically     addressed.      This study aims to evaluate the impact of a sexology consultation on diabetes balance     measured via HbA1c rate. This consultation aims at precising this particular symptom of     erection disorders, without any medicine prescription. The aim is to explain to patients the     different links between their symptoms, diabetes, medicines and themselves.   "
29497|NCT02899559|"     This primary object of this study is to test to the hypothesis that the both the nudge and     boost messages will increase short term gym utilization relative to the control condition but     that only the boost message will increase long-term gym utilization.      Non-technical summary: College students will receive one of three messages about exercise.     Their card swipe data as a measure of gym utilization will be tracked as an assessment of the     effect of those messages.   "
29498|NCT02899546|"     Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter     (PICC)-related infections among patients managed in the University Hospital of La Reunion for     PICC setting.   "
29499|NCT02899533|"     In this study positron emission tomography (PET/CT) imaging will be used to evaluate     evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial     Hypertension (PAH) using the investigational radiotracer [18F]fluoroestradiol (FES).   "
29500|NCT02899520|"     The objective of this study is to compare two methods of pelvic floor muscle training:     reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and     Control of Perineum)   "
29501|NCT02899507|"     The purpose of this study is to determine whether there is potential benefits of prophylactic     antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest (OHCA) treated     in intensive care unit with therapeutic hypothermia.   "
29502|NCT02899494|"     To emit voluntarily sounds mastered during the childbirth is a practice found in certain     cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical     coverage and because of the childbirth in a hospital environment, this tradition is not     anymore transmitted.      The emission of a sound vibration conjugated to a positive intention managed during the     childbirth was experimented with around thirty mothers. In the term of this pilot study, most     of the women expressed one felt very positive towards the new method, in particular when they     compared it with a previous childbirth where this method was not used.      During these childbirths, the midwives also indicated a shortening of the working time.      The present study aim essentially is to confirm the positive effect of the method on the felt     of the childbirth.   "
29503|NCT02899481|"     Investigators will perform a randomized controlled trial comparing the effect of     transabdominal and transperineal ultrasound in pregnant women in the second stage of labor,     in whom it was decided an operative delivery. Our objective is to evaluate the impact of     intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy     of an instrumental delivery.   "
29504|NCT02899468|"     The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual     reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with     traumatic brain injury (TBI). These patients, service members with TBI, can be both with and     without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to     improve cognitive and motor function, as well as mood.   "
29505|NCT02899455|"     A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and     HGP0816 in Patients with Hypertension and Dyslipidemia   "
29506|NCT02899442|"     With around 15 to 20% of workforce engaging in nightshift work in modern society for obvious     economic and social reasons, the consequences of night work on cardiovascular risks are     substantial. Compared to day workers, it was reported higher risks of cardiovascular diseases     (estimated at 40%) and of metabolic syndrome (1.5 times) in shift workers. The occurrence of     metabolic syndrome increases the risk to develop high blood pressure, diabetes and     cardiovascular events. Because some characteristics of night work are potentially modifiable,     some preventive strategies could be applied to reduce its adverse effects. For shift workers,     some recent guidelines (High Health Authority, 2012 & 2016) and fruitful literature propose     to develop regular assessments of cardiovascular risk factors and occupational activities,     and stress the need to expand preventive strategies. Moreover, some recent French laws     provide an opportunity to implement preventive interventions and specific monitoring through     the occupational physicians network. However, whether the concept is defined, the exact     content, method and the potential benefits are unknown. The investigator assume that     individual advice related to collective countermeasures referenced on guidelines (applied on     worksite within plant) could lead a better improvement on incidence of metabolic syndrome     compared to those that benefit only individual advice.      Main objective:      To measure the benefit from implementation of individual and collective prevention (dispensed     in worksites within plants) on metabolic syndrome compared to strategy relying only on     individual prevention among night workers, over 2 years' follow-up. The secondary objectives     of the study are to evaluate in both groups:        1. Observance of different types of preventive strategies        2. Impact of observance of preventive advice on metabolic syndrome in shift workers and on          each component of metabolic syndrome        3. Determinants which promote the up-take of preventive strategies among night workers        4. The countermeasures which could be applied and effective within company 5)          Medico-economic assessment is planned from an ancillary study.   "
29507|NCT02899429|"     Systematic study of the ultrasound infringements of tendons chest expanders of entheses the     most involved in spondylarthropathies and small joints of hands and feet in expanding     patients of psoriasis to estimate if there is an infra-clinical infringement of the psoriasic     rheumatism .   "
29508|NCT02899416|"     BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a     cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from     12.5 to 17.5 years old through 10 Europeans towns from 9 countries.      BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of     Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk     factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and     risk population cluster.   "
29509|NCT02899403|"     In the perspective to better evaluate the efficacy of new treatment strategies for Alzheimer     disease (AD), it appears important to develop experimental paradigms to precisely measure     cognitive endpoints/biomarkers that may be used in healthy volunteers as tools to validate     drug efficacy profile.      The use of Electroencephalography (EEG) may be, therefore, a good candidate. The purpose of     the present study is to use EEG to more precisely explore cognitive processes in healthy     subjects, with a particular interest in episodic and working memory functions that are     usually altered in both AD and Mild Cognitive Impairment (MCI) as well as to better     understand underlying neural mechanisms involved in these processes.   "
29510|NCT02899390|"     Diabetes is a major non communicable chronic diseases in the world. It occupies the fourth or     fifth leading cause of death in most high-income countries and there is strong evidence that     has epidemic proportions in many developing countries, including Mexico. Like diabetes,     prediabetes is associated with obesity and insulin resistance, thus promoting a lifestyle     with healthy eating and physical activity can reduce weight and in turn the risk of diabetes.      Several studies have shown that it is possible to prevent or delay the development of type 2     diabetes through a lifestyle intervention based on diet and physical activity. The National     Diabetes Prevention Program is a study based on the Diabetes Prevention Program conducted in     real-world conditions.      It is known that the acculturation of some ethnic groups has led to the increase in certain     chronic degenerative diseases due to increased associated risk factors. The rural Yaqui tribe     has a high prevalence of overweight, obesity, high triglycerides and type 2 diabetes. In     addition to the rural Yaqui tribe there is another settlement of this tribe in the city of     Hermosillo Sonora. Information on the health of this ethnic group is limited, however, it is     known that being seated in an urban setting with an obesogenic lifestyle, which has been     shown to have serious health effects in other populations, suggesting a high prevalence     chronic non-communicable diseases such as obesity, type 2 diabetes and hypertension at this     ethnic group.      The present study is a translational research clinical trial to evaluate the effectiveness of     the National Diabetes Prevention Program to improve obesity parameters (weight, BMI, waist     circumference) and increase physical activity in adults who are at risk of diabetes in the     Yaqui tribe established in Hermosillo, Sonora.   "
29511|NCT02899377|"     This is a pilot imaging study to determine whether molecular imaging with 18^F     fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT),     11^C-Methionine (MET) PET/CT, and salivary gland magnetic resonance imaging (MRI) with     Dotarem (gadoterate meglumine) have the potential to characterize and quantify disease     manifestations in primary Sjögren's syndrome (pSS) subjects. This will be achieved by     assessing the associations and consistency between the imaging techniques studied, clinical     assessments (salivary and tear flow and clinical scores), laboratory biomarkers, and     histological findings on minor salivary gland biopsy.      In this study, healthy volunteers will be enrolled in Group A and pSS subjects in Group B.     The subjects will be required to undergo screening and baseline assessments including     unstimulated and stimulated salivary flow and Schirmer's test; an imaging visit (Visit 1); a     sample collection visit (Visit 2) for repeat of selected baseline assessments and a minor     salivary gland biopsy for pSS subjects only; and a follow-up visit. The total duration of     participation in the study will be up to 11 weeks.   "
29512|NCT02899364|"     Rationale: the cornerstone treatment of a heart attack is a procedure called primary     percutaneous coronary intervention (PPCI): the cardiologist uses a catheter and guides it     through an artery, mostly the wrist artery, to the site of the narrowing in the coronary     artery in the heart and opens it with a balloon. Thereafter a small metal tube is placed at     the site of the narrowing to keep the artery open). However, a heart attack still leads to     irreversible injury to the heart with a risk of heart failure. The investigators have     evidence from (cell/animal) that administration of hydrogen sulfide (H2S), which is also made     in the human body, has been shown to protect the heart muscle and organs from damage caused     by the lack of oxygen resulting from a heart attack. Data in humans suggests that sodium     thiosulfate (STS) (a medicine that releases H2S in the body, and is already used to treat     other diseases, i.e. cyanide poisoning and renal failure associated diseases) can be     administered safely.      Objective: to evaluate if sodium thiosulfate protects the heart from damage caused by a heart     attack.      Study design: a single centre, double blind (both doctor and patient do not know which     treatment patient gets), randomized controlled clinical trial.      A total of 380 patients, aged 18 years and above, undergoing treatment for a first heart     attack are divided in two groups (decided by chance): 1 group receives sodium thiosulfate,     the other receives a fake medicine (salt water that looks exactly like sodium thiosulfate).      After 4 months patients receive a magnetic scan of the heart to evaluate the permanent damage     of the heart muscle. When comparing the patients from both groups to each other the     investigators can say something about the effectivity sodium thiosulfate.   "
29513|NCT02899351|"     In this research study, the investigators want to learn more about whether the Respiratory     Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of     age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to     measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the     number of times per minute a breath is taken (Respiratory Rate), and the amount of air going     in and out of the lungs per minute (Minute Ventilation).      It is important for medical staff to be able to collect information about breathing     non-invasively because it may help determine if certain children are experiencing breathing     problems sooner than the way it is currently detected.      The goal of this study is to determine if the Respiratory Volume Monitor works accurately in     infants less than 12 months of age.   "
29514|NCT02899338|"     To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after     single injection using either auto injector or prefilled syringe.   "
29515|NCT02899325|"     Liver cancer is one of the leading causes of cancer death among Asian men. If diagnosed early     the disease is treatable with surgery. Current conventional imaging modalities have     limitations to early detection. This study proposes to use 18F-FGal and 18F-FDG PET/CT scans     to compare the clinical efficacy of diagnosing hepatocellular carcinoma (a type of liver     cancer) using these PET/CT scans.   "
31156|NCT02877940|"     The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in     terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation     undergoing elective surgical procedure.   "
29516|NCT02899312|"     Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients     with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients     will have their PC return. Whether it has returned locally or distantly determines which type     of treatment they will receive. Current conventional imaging modalities have limitations     particularly at low prostate-specific antigen (PSA) levels. This study proposes to use     Fluorine-18-2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pen     tanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans     which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC     has recurred.   "
29518|NCT02899286|"     To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute myeloid     leukemia (AML) in terms of remission rate.   "
29519|NCT02899273|"     In Germany about 5 to 20% of children suffer from early childhood caries (ECC). Preceding     results of eye-tracking-studies on the perception of patients with unilateral cleft and     patients with severe orthognathic malocclusion let us assume that caries and missing teeth     might influence the observer's focus. The aim of this study is to test the hypothesis that     the faces of patients with ECC and patients with signs of dental treatment (crown, gap etc.)     are contemplated differently from and assessed more negatively than healthy patients.     Particular attention should be paid to potential differences between the findings of the two     observer-groups (medical laypersons/ dental students).   "
29520|NCT02899260|"     This study is designed as a prospective, randomized controlled trial that will compare the     use of the peanut exercise ball in laboring patients compared with no use of the exercise     ball. We hypothesize that use of the peanut ball decreases the incidence of cesarean section.   "
29521|NCT02899247|"     This trial, based on a split mouth and double-blind design, will evaluate the effects of a     surface sealant on the clinical performance of composite resin class I restorations.     According to eligibility criteria, 10 pairs of upper and lower molars or premolars will be     restored with Esthet X composite resin. For each pair, one surface will be sealed with     Lasting Touch surface sealant. A clinical evaluation will be performed by two experienced     operators using modified USPHS (United States Public Health service) after 5 years after     treatment. Data will be analyzed using the McNemar test (p < 0.05).   "
29522|NCT02899234|"     According to the World Health Organization cigarette smoking is today one of the leading     single causes of preventable death and morbidity. The electronic cigarette (e-cigarette) has     been marketed as a safer alternative to conventional cigarettes, and its global sales     continue to grow exponentially each year. Despite growing e-cigarette use, scientific data on     health effects are insufficient in some respects and completely lacking in others. Therefore     the current study is designed to investigate the effects of active e-cigarette inhalation on     the cardiovascular and respiratory systems.   "
29523|NCT02899221|"     This phase I trial studies the side effects and best way to give hyperthermia and high dose     rate radiation therapy in treating patients with prostate cancer that has come back after     prior radiation treatment. Radiation therapy, such as high dose rate brachytherapy, uses     radioactive material placed directly into or near a tumor to kill tumor cells. Hyperthermia     therapy may make tumor cells more sensitive to the effects of radiation therapy by heating     them to several degrees above normal body temperature. Giving hyperthermia and high dose rate     radiation therapy may work better in treating patients with recurrent prostate cancer after     radiation.   "
29524|NCT02899208|"     This study aims to investigate whether an actigraph, measuring in-hospital activity, used for     a week after discharge from the ICU at Zealand University Hospital Køge, can predict physical     function at three-month follow up.      The hospital activity will be measured with actigraphy, a measurement tool that quantifies     activity level. The activity will be measured for 7 days after ICU discharge. The actigraph     is to be worn as a bracelet.      The physical function will be measured with Chelsea Critical Care Physical Assessment Tool     (CPAx). CPAx is assessed at ICU discharge and after three months.   "
29526|NCT02899182|"     Introduction: Transrectal ultrasound-guided prostate biopsy (TUPB) is the gold standard     diagnostic tool for prostate cancer and, though may be well tolerated for some patients,     about 65 to 90% of then still complain of discomfort, weather associated or not to pain.     Therefore, as a manner of improvement in visual analogic pain score (VAS) and satisfaction     between those patients, the aim of this study is to propose the gas mixture N2O-O2 50-50%, as     a non-invasive, safe and cost-effective method to deliver analgesia and/or sedation, without     the need for an anesthesiologist.      Materials and methods: A randomized clinical trial, simple blind, which took place in     Hospital Universitário Antônio Pedro, Niteroi, RJ, within two groups containing 42 patients     each, divided in conventional (C), which received 100% oxygen and nitrous oxide (NO), which     received inhalation of the mixture N2O-O2 50-50% from a self-demand valve during exam. They     were accessed for pain with VAS, answered a satisfaction task and were recorded about     collateral side effects.   "
29527|NCT02899169|"     The investigators design a multicenter randomized controlled trial to prove that RIF plus     ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the     patients with non-high-risk APL.   "
29678|NCT02897206|"     This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical     trial that aims to investigate the beneficial and harmful effects of prophylactic use of     imipenem in patients with predicted severe acute pancreatitis. All patients with first attack     of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II     score ≥ 8 calculated within the first 24h from admission will be enrolled.   "
29528|NCT02899156|"     Delirium within the intensive care unit (ICU) is associated with poor outcomes such as     increased mortality, ICU and hospital length of stay (LOS), and time on mechanical     ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of     delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing     duration of delirium and subsequent complications.      This is a single-center randomized, double-blind, placebo-controlled study of critically ill     adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that     flumazenil continuous infusion reverses hypoactive delirium associated with BZD toxicity and     thereby reduces duration of delirium and ICU LOS.   "
29529|NCT02899143|"     The purpose of this study is to compare the effect of a short course antimicrobial therapy     (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.   "
29531|NCT02899117|"     The proposed project will examine feasibility and preliminary efficacy of a yoga intervention     in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes     two parts: (1) a survey of children and parents regarding preferences (e.g., convenient     days/times), experiences and expectations regarding yoga (including barriers and positive     expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of     children and parents.   "
29532|NCT02899104|"     Categorize the clinical parameters and patient determinants that drive physician decision     making for treatment selection including Radium-223 for patients with mCRPC.   "
29533|NCT02899091|"     The objective of the study is to evaluate the safety and the potential therapeutic effects of     CB-AC-02 Intravenous Transplantation in patients with Alzheimer' disease comprised of 2     treatment cohorts:   "
29534|NCT02899078|"     This phase Ib/II trial studies how well ibrutinib and nivolumab work in treating patients     with previously-treated kidney cancer that has spread to other parts of the body. Ibrutinib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to     grow and spread. Giving Ibrutinib and nivolumab may work better in treating patients with     metastatic kidney cancer.   "
29535|NCT02899065|"     This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate (in     aggregate) both the use of the Cepheid GeneXpert Flu/RSV Assay and the use of pharmacist-led     education for providers in the interpretation of these test results.   "
29536|NCT02899052|"     A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of     venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed     or refractory MM and have received 1 to 3 prior lines of therapy.   "
29537|NCT02899039|"     IgG4-related disease is a rare and very recently identified pathology, whose frequency is     certainly underestimated.      The clinical presentation varies among affected organs, and most often, patients have at     least three organ damage.      These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe     fibrosis progression resulting in a loss of function.      The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological     marker, currently held by several teams, is the presence within the inflammatory infiltrate,     of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG     +> 50% on tissue immunostaining.      The investigators project provides a global assessment of T lymphocyte abnormalities and     specifically the TFH (Follicular Helper) during this IgG4-related disease compared to     so-called groups control subjects suffering from Sjogren syndrome or healthy subjects.   "
29538|NCT02899026|"     Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine     with high affinity that may have therapeutic benefit in the treatment of polymyalgia     rheumatica (PMR) by interrupting multiple pathogenic pathways. Sirukumab inhibits     IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation,     resulting in the inhibition of the biological effect of IL-6. This study will evaluate the     efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in     the treatment of active PMR. The study will be conducted in 2 parts (Part A and Part B) and     consists of the following phases: Screening phase, Part A: 52-week double-blind treatment     phase, Part B: 52-week extension phase with no study drug administration and a 16-week     follow-up phase if applicable.      Approximately 150 subjects with a diagnosis of PMR and active disease within 6 weeks of     baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive     one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone     taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week     52. Subjects completing Part A of the study who are in clinical remission will be eligible to     enter Part B, the 52-week extension phase, designed to investigate the long-term maintenance     of remission and safety following cessation of sirukumab treatment and to assess long-term     corticosteroid use. Subjects will need to have follow-up safety evaluations for at least 16     weeks after receiving the last dose of study drug, applicable for those who have withdrawn     prematurely from the study or who have completed Part A but are not eligible for Part B.   "
29539|NCT02899013|"     The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years     after the first cases of luminal disease. If phenotypic data of the latter are well     documented today, those of perianal disease remain inadequately described. The reasons are     numerous: understated symptoms by patients, elementary semiotics proctology ignored by     practitioners, lack of validated classifications to track these violations and challenges to     undertake clinical trials to high standard of proof in view of these variables, etc. ...     Moreover, the impact of these LAP varies across studies (10-80%). in addition to the     above-mentioned reasons, these results are also due to the different definitions of LAP used     in the studies, their collection in reference centers versus tertiary centers, their     potential occurrence at any time of disease progression, their greater frequency in case of     distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of     colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be     better documented because they are a factor of poor prognosis of Crohn's disease.   "
29541|NCT02898987|"     The objective of the Dataids cohort is to continue a long-term, prospective collection of     clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking     care in 15 HIV centers in France in order :        1. to provide and develop a surveillance system to describe clinical practice and temporal          changes in the clinical course of HIV and HIV-related co-infections and co-morbidities          in France.        2. to assess the factors associated with the clinical, immunological and virological course          of HIV infection and HIV-related co-infections and co-morbidities      The specific objectives are as follows        -  To continue surveillance of HIV infection in France to describe temporal changes        -  To evaluate the efficacy of ART and factors associated with ART efficacy        -  To monitor the uptake and outcome of HCV therapy   "
29747|NCT02896309|"     This study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal     renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney     disease. This treatment is compared to sodium chloride treatment, which serves as control for     increased sodium-intake and no treatment, which serves as time-control.   "
29542|NCT02898974|"     Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom,     e.g. spasticity and pain, management. Unfortunately not much is known about its effects     outside the treatment for these 2 symptoms. Several previous studies have suggested people     with MS using medical marijuana have lower levels of physical disability and improved walking     abilities. A major limitation of these previous studies is that the investigators used     subjective measures of motor function. In this proposed observational case-control study the     investigators plan to objectively measure multiple domains of motor function, such as:     fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to     participants.   "
29543|NCT02898961|"     Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in     ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg     gentamicin achieved target concentrations in ICU patients with severe sepsis.   "
29544|NCT02898948|"     Levels of PCT (a marker of bacterial infection) are highest during sepsis: in fact, PCT is     normally produced by the C cells in the thyroid gland. PCT was initially studied by Assicot1     for distinguishing between bacterial meningitis and viral meningitis. The CALC-I gene codes     for PCT. In the absence of infection, the extrathyroid mRNA expression of the CALC-I gene is     repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells.     Infection induces the ubiquitous expression of the CALC-I gene. PCT is not transformed into     calcitonin in parenchymatous tissues. In a context of sepsis, the whole body acts as a     neuroendocrine gland. Sepsis upregulates PCT mRNA expression much more than that of other     cytokines.      PCT is used in critical care departments as a diagnostic marker, a guide to treatment     (antibiotics are withdrawn if the level falls) and a prognostic marker.      There are few data on the diagnostic use of PCT in an internal medicine department. The     available studies yielded contradictory results and only one prospective study has been     performed . The objective was to study PCT in non-infectious, inflammatory pathologies and to     establish whether PCT could distinguish infections from other inflammatory pathologies in     patients in an internal medicine department. In a ROC curve analysis, a PCT threshold of 0.35     µmol/l gave the greatest specificity (88%) and sensitivity (72%). Other studies have been     performed but featured small sample sizes and a retrospective design.      Of the various studies performed in internal medicine departments, none included patients     presenting with a suspected bacterial infection (according to the clinician's interpretation)     and lacking information on their bacterial status. In fact, these diagnoses are a core     component of hospitalisation in internal medicine departments for fever or inflammatory     syndrome. The investigators intend to include all patients, including those lacking     information on their microbiological status).   "
29545|NCT02898935|"     Reconstruction software allows visualization of cortical structure in 3 dimensions, showing     on a single picture the position of all the electrodes. The EEG signal of each recording plot     of the electrode is analyzed and compared with the underlying brain structure reconstructed     by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas     using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional     cortical areas with functional imaging and SEEG. Software makes it possible to determine the     links between these areas. This study aims to show that using these software is an asset in     surgical decision and in the choice of surgical strategy.      Each patient has presurgical evaluation (usual care), including morphologic and (if     necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the     processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist.     The surgical decision will be taken according to the usual staff procedures, based on the     usual examination results. After the decision making process, the staff will be asked to     reconsider the surgical decision, according to the analysis provided by the software. The     discrepancies between the decisions will be recorded.   "
29546|NCT02898922|"     Background Hepatitis B virus (HBV) co-infection in individuals with hepatitis C virus (HCV)     can enhance the severity of hepatitis and the risks of liver cirrhosis and hepatocellular     carcinoma (HCC). Hepatitis B vaccine is an effective measure to prevent HBV infection.     Whether patients with HCV infection have non-protective antibody responses to hepatitis B     vaccination more frequently than healthy subjects is still controversial and studies about     cytokine response have been seldom reported.      Methods Not-in-treatment patients with chronic HCV infection and 1:2 community/gender matched     healthy control were obtained from a community-based screening. All participants received     three doses of hepatitis B vaccine (20 μg HBsAg/ml/dose) on 0, 1 and 6 months schedule.     Anti-HBs was tested 1 month after the third dose of vaccination and was compared between two     groups. Spot-forming cells (SFCs) of interferon-γ (IFN-γ), interleukin-2 (IL-2),     interleukin-4 (IL-4), interleukin-5 (IL-5) and interleukin-6 (IL-6) produced by lymphocyte     were tested by enzyme-linked immunospot (ELISPOT) and were compared between two groups.   "
29547|NCT02898909|"     Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed     by ultrasound phacoemulsification of nuclear lens, which is then removed.      It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the     post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of     ultrasonic energy.      The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the     patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal     transparency.   "
29548|NCT02898896|"     HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a     substantial proportion of obstructive CAD. Degree of stenosis is associated with     immunoactivation (lymphocyte and monocyte) and microbial translocation   "
29562|NCT02898714|"     On the first of July 2016, the Freestyle Libre Flash Glucose Monitor (FGM) will be reimbursed     in Belgium by means of a new diabetes reimbursement program for adults. For children, the     Freestyle Libre FGM is also reimbursed by means of a new reimbursement program from the first     of August 2016 onwards. Making this the only way to receive the device in Belgium. To     understand the impact of this new FGM on diabetes patients in UZ Leuven and OLVZ Aalst, we     want to study the use of the device by our patients by means of an observational study where     patients complete questionnaires at regular time points in the first year of usage and after     24 months Clinical data will be gathered during the routine clinical visits as part of the     reimbursement program.   "
29549|NCT02898883|"     The investigators study seeks to evaluate the feasibility and efficacy of a parent-focused,     early intervention to prevent the development of chronic PTSD for children admitted to the     emergency department for an acute traumatic injury and their parents. Furthermore, the     investigators will identify potential risk factors for the development of PTSD and factors     that influence treatment response. Finally, the investigators will prospectively measure     trajectories of parental and child responses to trauma and their interaction over time. This     study will bring together a multidisciplinary team across two major research universities     (Case Western Reserve University and Kent State University) and a large pediatric trauma     center (Akron Children's Hospital) in an effort to reduce rates of PTSD in children following     traumatic injury.   "
29550|NCT02898870|"     The link between the products of synthetic chemistry and cancer is at the heart of much     research. Recent work has identified the use of plant protection agents by farmers as a risk     factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL)     is the most common histology. Different biological models were used to understand the role of     pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and     molecular level, on different signaling pathways. After metabolized by cytochrome P450, these     compounds generally become pro-oxidants. The increase in reactive oxygen species rate (SAR)     causes the activation of signaling pathways involved in cell proliferation and survival. But     deregulation of oxidative status does not in itself justify the specificity of the impact of     pesticides on specific pathologies. Several agents have a genotoxic effect, others induce the     activation of signaling pathways by binding to transcription factors and others have     immunomodulating properties.   "
29551|NCT02898857|"     Every year in France, 30.000 deaths are due to lung cancer and 39.500 new cases of this     disease are diagnosed (INCa 2014). Patients suffering from locally advanced non-small-cell     lung cancer (NSCLC), stage IIIa, usually undergo a multimodality treatment including     chemotherapy with platinum compounds before surgery (called neoadjuvant chemotherapy or     induction chemotherapy). The reason of this combined modality treatment is the really poor     prognosis of patients presenting a disease already spread to lymph nodes (classified N2 when     the lymph node under the carina is affected). Up till now, the five-year survival of patients     who underwent surgical resection of N2 NSCLC does not exceed 15%   "
29552|NCT02898844|"     This study examined how dieting with a partner affects weight loss, diet adherence,     psychological well-being, and cortisol.   "
29553|NCT02898831|"     This study will be a prospective randomized controlled trial comparing cold compression to no     intervention immediately prior to and during intrauterine device insertion. Subjects will be     randomized to cold compress or no intervention (standard practice in our clinics). Following     IUD insertion they will complete a validated pain scale survey regarding their pre-procedure     and intra-procedure pain.   "
29554|NCT02898818|"     To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear     will be studied.   "
29555|NCT02898805|"     The study is designed to compare the effects of two combination of nutraceuticals: Armolipid     Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red     Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment     with one of the combinations, according to a randomized scheme, on metabolic parameters in     dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it     will assess the ability of the two combinations to reduce the levels of total and LDL     cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.   "
29556|NCT02898792|"     Obstructive Sleep Apnea (OSA) is the most common problem that affects sleep. People with this     problem have their airway blocked or minimized, causing snoring or gasping while sleeping. It     can also reduce the amount of oxygen that circulates in the blood of people affected by it.     Millions of Americans have OSA; 10% of adults have diagnosed OSA, an estimated 25% have     undiagnosed OSA. There is concern in the medical community about how to manage pain in     patients with OSA because of the risk of decreased or slower breathing associated with     certain pain medications called opioids. Giving OSA patients opioids could cause them to have     even lower oxygen amounts in their blood stream. It is conceivable that patients with OSA may     require lower doses of opioids to cause decreased breathing as compared to patients without     OSA, however this has not been proven. In this study, we are using a very short acting and     easily reversible opioid pain medication called remifentanil in patients with OSA in order to     find out if treated and untreated OSA patients respond to opioid differently than patients     without OSA.   "
29557|NCT02898779|"     To investigate the comparative tolerability, metabolism and pharmacokinetics of individual     enantiomers of PQ in healthy human volunteers. The specific aim is the comparative evaluation     of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of PQ (RPQ and     SPQ and the racemic mixture RSPQ) in normal healthy human volunteers.   "
29558|NCT02898766|"     This will be a randomized, cross-over design. Subjects will be randomized to one of two     interventions on two separate study days, 1 week apart.   "
29559|NCT02898753|"     Phase I/II study enrolling up to 12 patients in a three-month, Open-label, Randomized,     Parallel Active Control, Single and Repeat Dose, Dose-escalation Study of the Safety,     Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of     VAL-1221 Delivered Intravenously (IV) in Ambulatory and Ventilator-free Patients with     Late-Onset GSD-II (Pompe Disease) Study   "
29560|NCT02898740|"     This project is investigating whether a home-based exercise program will reduce depression in     patients with Parkinson's disease.   "
29561|NCT02898727|"     This study aims to show that brain metastases from Human Epidermal Growth Factor Receptor     Type 2 (HER2) positive breast cancers are able to be controlled by local therapies,     Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain     Radiotherapy (WBRT).   "
29583|NCT02898441|"     The present study is a randomized controlled trial of LDCT screening for lung cancer versus     usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active     arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in     usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung     cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples     were stored from the Active arm in a Biobank. Management of positive screening test was     carried out by a pre-specified protocol.   "
29563|NCT02898701|"     This study contains two pilot studies: 1) one study will investigate practice dosage of a     postural stepping task in healthy young individuals in order to determine an operational     definition of performance plateau, and 2) the other study will investigate whether practicing     beyond reaching a performance plateau improves learning of a postural stepping task in     healthy older adults, compared to discontinuing practice immediately after reaching a     performance plateau. The investigators hypothesize that the group that continues to practice     beyond reaching their performance plateau will learn and retain the motor task better than     the other group.   "
29748|NCT02896296|"     Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who     complete the RB-US-13-0003 study and for whom a new treatment venue has not been identified.   "
29564|NCT02898688|"     This study will address vaccine uptake both for pregnant women and for their children,     through 20 months of age, to test the hypothesis that exposure to the P3+ intervention     package will increase the likelihood a pregnant woman gets herself vaccinated against     influenza and pertussis before delivery and get her child vaccinated on time. This study     builds off of a prior intervention, developed by Emory, at the practice, provider, and     patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to     improve vaccination uptake among pregnant women, and later, their children.   "
29565|NCT02898675|"     Platelet rich fibrin is a second generation platelet concentration which contains various     growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of     PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.   "
29566|NCT02898662|"     Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark,     Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized     patients with eosinophilic, moderate to severe asthma. The patients will receive 13 once     weekly inhaled doses of the study drug. Treatment is initiated on top of their ICS/LABA     controller medication, which is then tapered down and withdrawn during a period of 3 weeks     and during the last 3 weeks of treatment the study drug is given as monotherapy. SABA is used     as reliever medication during the whole study period. Primary endpoint is Loss of asthma     control. When the endpoint is met, patients will resume their ICS/LABA, will be followed for     an additional 4 weeks and will thereafter discontinue the study.   "
29567|NCT02898649|"     Pancreatic cancer is 5th leading cause of cancer-related death in Korea. It has a dismal     prognosis with very low 5-year survival rate, about 5%. Only 10% of pancreatic cancer     patients is diagnosed in operable status. So, most of patients could not be treated with     curative resection.      Locally advanced pancreatic cancer (LAPC) is defined by defined as surgically unresectable     due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but     have no evidence of distant metastases. In LAPC patients, systemic chemotherapy with/without     radiotherapy was used as a standard therapy, but therapeutic response was very poor. Only     less than 30% of patients showed treatment response, and median survival of LAPC patient was     only 9 months. Thus, more effective treatment modality is needed for LAPC patients.      Irreversible electroporation (IRE) is a soft tissue ablation technique using ultra short but     strong electrical fields to create permanent and hence lethal nanopores in the cell membrane,     to disrupt the cellular homeostasis. IRE does not cause thermally induced necrosis and has     tissue selectivity, so adjacent tissue or vascular structures can be preserved.      Several clinical trials using IRE were performed to liver, kidney or lung cancer patients. We     will operate IRE procedure to LAPC patients who were previously received standard therapy but     showed no response, using NanoKnife IRE device. We will investigate treatment response and     safety of IRE.   "
29568|NCT02898636|"     Identify the cytokine or combination of cytokines, with the best diagnostic performance to     characterize the vital nature of a skin wound in the body.   "
29569|NCT02898623|"     TB remains a health problem in France with about 5,000 new cases per year. Development of new     screening tests is a priority for TB. The main objective of the study is to evaluate     performances of innovative blood tests to identify active tuberculosis in adults patients     living in low-prevalence country. Adult patients with possible TB from will be tested for the     presence of antibodies directed against M. tuberculosis selected antigens. Positive and     negative predictive values will be established based on TB culture results.   "
29570|NCT02898610|"     This study evaluates the use of Colchicine in adults over 40 years of age who have suffered     an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other     defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or     to usual care alone.      To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as     antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice)     compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial     infarction, cardiac arrest, hospitalization for unstable angina and vascular death after     ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other     defined causes unrelated to atherosclerosis   "
29571|NCT02898597|"     As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as     cardiovascular diseases and cancers on these people have consistently increased. Smoking is     one of the major contributing factors to these health problems and rates of cigarette smoking     in this group are substantially higher than those of the general population: 40-70% vs.     17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative     consequence of smoking than their male counterparts. They are also less likely to see tobacco     dependence treatment for dual stigma associated with both conditions: HIV infection and     nicotine addiction. This is a pilot study to develop smoking cessation intervention for these     women.   "
29572|NCT02898584|"     The purpose of this research study is to test the feasibility, acceptability, and preliminary     effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP     monitoring and medication reminders with patients recruited from a primary care setting, as     well as identify challenges and potential solutions to broader implementation of a mobile     pharmacist-led home-based BP monitoring intervention in primary care clinics through key     stakeholder interviews.   "
29573|NCT02898571|"     The aim of this project is to measure the differences in antioxidant capacity at different     time points after consuming a single dose of antioxidant-containing drink (vitamin C or     epicatechin) compared with a control drink in 10 volunteers, and then match the data with the     proposed modelling corresponding to either homeostasis or accumulation. Additionally it will     also determine whether the effect on changes of antioxidant capacity in response to     epicatechin and vitamin c is equal.   "
29665|NCT02897375|"     This phase I trial studies the side effects and best dose of palbociclib with cisplatin or     carboplatin in treating patients with solid tumors that have spread to other places and     usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth     in patients with advanced solid tumors.   "
29574|NCT02898558|"     This study explores the possible implications of the increase in perceived body size for     rehabilitation of motor functions. In a recent study we have tested if motor abilities of     patients with stroke improve wearing magnifying lenses, showing that a beneficial effect of     magnifying lenses can be observed in some patients. In the present study, we will identify 12     patients from this cohort who demonstrated an improvement greater than 10% in one or two     motor task when wearing magnifying glasses. These participants will be invited to take part     in a clinical study in which they will undergo a training phase: subjects will wear     magnifying lenses at home for 30 minutes daily for 14 days while completing a jigsaw puzzle;     a log will be kept to document participation. Participants' performance on different motor     tasks will be assessed before, immediately after and 1 month after the training session.     Standardized measures of motor performance will include the the Action Research Arm test and     the Rivermead Assessment of Somatosensory Performance (RASP). In addition, participants will     undergo grip strength, finger tapping tasks and a reaching and grasping task. We expect the     repeated use of magnifying lenses to generate an improvement of patients' performance across     tasks and this effect to be persistent in time.   "
29575|NCT02898545|"     This study will evaluate the recurrence rates of atrial fibrillation that develops in the     hospital following non cardiac procedures or surgeries or acute medical illnesses.   "
29576|NCT02898532|"     Practising target shooting sport requires focused attention and motoric steadiness. Parental     reports suggest that children with attention-deficit/hyperactivity disorder (ADHD) benefit     from participating in target shooting sport in Danish Shooting Associations.      Aim: This study aims at examining if and to which extent target shooting sport in children     with attention difficulties reduces parent- and teacher-reported severity of inattentiveness,     hyperactivity, and impulsivity, and improves the children's well-being and quality of life.   "
29577|NCT02898519|"     Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira)     growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas     aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major     public health issue.      An important inter-individual variability in humoral immune response suggests that     vaccination should be recommended in exposed subjects.      This cohort study aimed to determine if subjects that have been infected by leptospirosis for     1 to 7 years still remain immunized, and then do not need vaccination.   "
29578|NCT02898506|"     The objective of the trial is to study whether daily treatment with liraglutide improves     endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is     tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet     autoantibodies and have dysglycemia.   "
29579|NCT02898493|"     The evaluation of quality of life in health is particularly important for measuring the     impact of the chronic diseases. The scales of measure constitute the main measurement tool in     clinical trials because of their psychometrics properties and of their ease of use.      Among these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions     questionnaire ( EQ-5D) were widely validated in various populations, of which the population     of the diabetics patients. Both scales have validated versions in French.      In the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject of     many clinical and epidemiological trials. One of the difficulties encountered during the     implementation of these studies is the absence of measurement tools validated for these     populations.      Investigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and     Reunion Island, adapting and validating these scales according to an identical procedure in     Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French     versions of these scales in their populations of type II diabetics patients.   "
29580|NCT02898480|"     Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue     against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown     whether this can be used in retinal vascular occlusive diseases. The purpose of the present     study is to examine whether the autoregulation of retinal vessel diameters in normal persons     change after remote ischemic conditioning.   "
29581|NCT02898467|"     Intraplaque hemorrhage is the driving force of atherothrombotic plaque vulnerability to     rupture and associated clinical complications. Polymorphonuclear neutrophils (PMNs) represent     about 70% of leukocytes and may constitute a source of proteases and oxidants that favour     plaque rupture. Our objective is to evaluate PMN activation in atherosclerotic plaque of     non-diabetic versus type 2 diabetic patients. For this purpose, investigators will quantify     the presence of cell-free DNA, that reflect the formation of neutrophil extracellular traps     (NETs) in carotid endarterectomy samples.   "
29584|NCT02898428|"     With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels     and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and     formula feeding new mothers with type 1 diabetes at the second after delivery diabetes     control compared with the first after delivery diabetes control at Steno Diabetes Center.   "
29585|NCT02898415|"     Liver transplantation (LT) is one of the curative treatment options for patients with HCC     associated to chronic liver disease (cirrhosis). All current international guidelines     recommend LT for HCC only within pre-defined criteria The use of restrictive criteria to     select patients affected by HCC for LT was originally proposed with the Milan criteria. These     criteria were based on pathologic assessment of number and size of the HCC nodules on the     explanted liver. Subsequently, many authors proposed the expansion of such restrictive     criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on different     combinations of morphologic parameters, have been defined on the pathologic staging of the     tumor made on the removed liver, namely after LT, once decision on treatment and treatment     itself could not be changed Although post-LT pathology / pre-LT radiology correlation have     improved over time, significant biases still affect clinical assessment of HCC stage and no     reliable protocols has entered clinical practice yet. In addition, robust evidence indicates     that other biological markers of aggressiveness (such as α-FP levels and clinical response to     bridge therapies) have to be added when evaluating pre-operative variable Although many     studies have been conducted, prognostic calculators of cancer-specific survival for HCC     patients undergoing an evaluation for LT are not yet available. Such models should be able to     provide survival estimates based on pre-treatment oncologic variables.      The main goal of the study is the definition of a cancer-specific prognostic model based on     pre-operative features (radiologic staging and α-FP levels) of a wide population of patients     who underwent LT for HCC.      Considering the competitive risk of cancer-specific mortality and death due to other causes,     the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the     base of pathologic staging   "
29666|NCT02897362|"     This study seeks to characterize sleep physiology in adolescents with and without Attention     deficit hyperactivity disorder (ADHD) and its relationship to differential neurocognitive and     clinical outcomes within these groups.   "
29586|NCT02898402|"     Emergent and infectious diseases are a public health priority on Reunion Island. Amongst     public health threats, the infection due to Coxiella burnetii (Q fever) seems to have     appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one     probable case with a goat farmer.      According to the investigator, the diffusion of C. burnetti is more ancient and such     diagnosis have been made in the last 30 years with 80 positive serologies identified between     2005 and 2011.      Considering the high epidemic power of this disease, its often silent clinical expression and     its life-threatening condition, the principal investigator wishes to perform a     sero-epidemiological study in order to establish or to reject the risk of emergence of Q     fever in Reunion island.      The study will be performed on pregnant women because Q fever is responsible for particular     complications during pregnancy and because the number of pregnancy followed on Reunion island     is stable from one year to the other. The pregnant women population presenting the same     exposure criteria as the general population, this population will be used to extrapolate to     the general population of the island.   "
29587|NCT02898389|"     The primary objective of this study is to show that cardiovascular risk factors associated     with the chronic elevation of arterial resistance may be associated with false profiles of     intracranial hypertension during transcranial doppler ultrasound of the middle cerebral     arteries in intensive care unit patients. A false profile of intracranial hypertension is     defined by a high pulsatility index without any intracranial pathology.   "
29588|NCT02898376|"     This study evaluates the dermatological life quality six months after spa cares in patients     with severe late toxicity involving the skin and / or soft tissues after postoperative     radiotherapy for breast cancer. Half of the patients will be treated with a combination of     pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive     skin-oriented spa cares in addition.   "
29589|NCT02898363|"     Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in     France, develop as many cancers as persons in the general population. However, their tumors     are different by their particular organ distribution, the age of onset, the biological     background (2,000 genetic conditions are associated with an intellectual disability) and     above all the unusual clinical presentation. These cancers are not well known from     physicians, carers and families, and often discovered late. A recent review of the literature     shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of     cancer in these patients. Currently, no population study on clinical features and stage at     diagnosis of cancer in PWIDs is available. No interventional research study has been     conducted on this subject.      Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result     from a direct link between intellectual disability and cancer, but are related to diagnosis     difficulties of these tumors which are not well known, and to difficulties of communication     with these patients who do not express easily their symptoms, particularly pain.   "
29590|NCT02898350|"     Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and     efficacy of combined treatment for minimizing of surgical scars, including post Moh's     surgery.   "
29591|NCT02898337|"     Torsades de pointes (TdP) is a polymorphic ventricular tachycardia associated with     prolongation of the heart rate-corrected QT (QTc) interval on the electrocardiogram (ECG).     TdP can result in catastrophic outcomes, including sudden cardiac death. QTc interval     prolongation is a well-known adverse event associated with methadone use. While some risk     factors for methadone-associated QTc interval prolongation and TdP have been identified, the     contribution of interacting drugs and concomitant administration of other QTc     interval-prolonging agents to overall risk has not been determined. The effect of ECG     screening and monitoring on clinical outcomes in patients taking methadone has not been     evaluated, and clinical opinion regarding routine ECG and risk factor monitoring varies.     Twelve lead ECGs are costly and time-intensive for clinic staff. ECG screening in selected     patients based on presence of QTc interval risk factors, rather than broadly in all patients     taking methadone, would facilitate more targeted, strategic QTc interval monitoring. The     FDA-approved AliveCor® handheld smart phone/tablet device records a single lead ECG (iECG)     within 30 seconds. Use of this device may facilitate simpler, more rapid and less costly ECG     monitoring in patients receiving care in narcotic treatment centers.      Our long-term goals are to determine mechanisms by which drugs cause arrhythmias, to identify     patients at greatest risk of drug-induced arrhythmias, and to determine safe and effective     methods for prevention and management of drug-induced arrhythmias.      Specific Aim 1: Identify independent risk factors for methadone-induced QTc interval     prolongation in patients undergoing care in a narcotic treatment center.      Research Design: This will be a retrospective/prospective analysis of ECGs and health     information from patients receiving methadone therapy in the Eskenazi Health Midtown Narcotic     Treatment Center in Indianapolis, IN. Currently, at the Midtown Narcotic Treatment Center,     baseline 12-lead ECGs are recorded for all patients prior to initiation of methadone therapy;     follow-up ECGs are obtained approximately 2 weeks after methadone initiation only in patients     with a baseline prolonged QTc interval. At the start of the study, methadone-treated patients     who have not had follow-up ECGs on methadone therapy will be identified and contacted     prospectively. Those consenting to participation will undergo a follow-up 12-lead ECG to     determine QTc interval during methadone maintenance therapy. For all patients, retrospective     analysis of the electronic medical record will be performed to document sex, pregnancy     status, age, family history, current and past medical history, and concomitant use of     prescribed, over the counter, and illicit drug use with the aim to identify all potential     risks. QTc interval prolongation will be defined as QTc interval ≥ 500 ms or an increase in     QTc interval of ≥ 60 ms compared with the baseline QTc interval. Electronic health     information variables will be compared in patients who develop methadone-associated QTc     interval prolongation versus those who do not using univariate analysis. Patients with     prolonged QTc interval at baseline will be excluded from the study.      Specific Aim 2: Validate the handheld AliveCor® smart phone/tablet iECG device as a simple,     rapid method of monitoring QTc intervals in methadone-treated patients in a narcotic     treatment center.      Research Design: A separate cohort of patients will be utilized to validate the AliveCor®     device for use in measuring QTc intervals in patients initiated and maintained on methadone     in a narcotic treatment center. Twelve lead ECGs and simultaneous single lead ECGs using the     AliveCor® device will be recorded for all newly enrolled patients at baseline and again after     six weeks of methadone therapy. The QTc identified by the 12-lead ECG will be compared to the     single lead ECG for all baseline and follow-up recordings to validate the use of the     AliveCor® device for potential use in narcotic treatment centers to reduce cost and save     time. Comparison of QTc intervals between the 12-lead and single lead measurements will be     performed using the Bland-Altman method for analysis of measurement agreement. The mean and     95% confidence interval of the difference in QTc interval between the two methods will be     calculated.      This will be a pilot study to justify a larger extramural study to develop and validate a     risk score for methadone-induced QTc interval prolongation and to use the handheld ECG device     for QTc interval monitoring in patients identified as high-risk using this risk score. Our     rationale is that identification of risk factors for methadone-induced QTc interval     prolongation and quantification of degree of risk conferred by each risk factor will     ultimately reduce the incidence and risk of QTc interval prolongation through targeted ECG     monitoring of patients at highest risk and modulation of modifiable risk factors.   "
29592|NCT02898324|"     Bullying is a major problem worldwide and, with no exception, in Chile. Bullying is defined     as a systematic aggressive behavior against a victim who cannot defend himself or herself.     Victims suffer many consequences such as social isolation, psychological maladjustment, and     self-injury behavior. Additionally, bullies have a higher risk for conduct problems and     substance use disorders. These problems appear to last in time, affecting mental health even     years later since the experience of bullying.      There are few studies in Chile aiming to determine the prevalence of bullying. In one of such     studies, 47% of the students reported having been bullied during the last month before the     application of the questionnaire. Even though there are many initiatives and guidelines in     Chile supported by the government to help schools in order to deal with bullying, there is no     any cluster randomized controlled trial (RCT) aiming to assess the effectiveness of an     anti-bullying program.      KiVa anti-bullying prevention program contains universal and indicated actions. Main     universal actions for 5 to 6 graders consist of 10 two-hours lessons given during a year and     an online game, which have the aim to raise awareness of the role of the group in bullying,     increase empathy and promote strategies to support victims. Indicated actions consist of a     set of discussion groups with the victims and with the bullies with proper follow-up.      The aims of this study are: 1) To develop a culturally appropriate version of the Kiva     material, and 2) to test its effectiveness of KiVa program with and without the online game,     to reduce bullying behavior among low-income primary schools in Santiago using a cluster RCT     design with three arms: i) KiVa full program group, ii) KiVa without online game program     group, and iii) Control group.   "
29593|NCT02898311|"     This study evaluates the success rate, as the biological and prosthesis complications, of     posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and     Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5     years.      Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The     time and cost benefit of the presented digital workflow, as patient centered outcomes will     also be evaluated.   "
29594|NCT02898298|"     The purpose of this study is to evaluate the efficacy of a novel positive emotion regulation     intervention that aims to increase positive emotions and improve emotion regulation skills in     children, adolescents and young adults. The study focuses on individuals with a developmental     disorder such as Autism Spectrum Disorder and other Learning or Developmental Disabilities in     comparison to typically developing (TD) controls. Participants will complete a     psycho-educative training to learn about positive emotions and how to increase them in their     daily lives. Participants are expected to benefit from the training, which will be evident in     a change in emotion experience, emotion regulation strategy use, and well-being. Emotion     regulation efficacy will be related to symptom severity (autistic symptoms), alexithymia and     problematic behaviors.   "
29667|NCT02897349|"     To evaluate the efficacy and safety of linagliptin compared to placebo when added on to     insulin therapy alone or in combination with metformin in Chinese patients with type 2     diabetes mellitus with insufficient glycaemic control   "
29668|NCT02897336|"     An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and     interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related     sciatica.   "
29595|NCT02898285|"     The primary objective of this investigation is to test the efficacy of two sport     participation formats (individual sport, team sport) on key psychosocial outcomes compared to     a non-sport condition among parents of young children who were not participating in sport at     baseline of the study.      Research of this type is important because parents represent a group dealing with numerous     challenges and this is a period of time shown to have the greatest decline in physical     activity. Furthermore, parents could reap great benefits in psychological health through the     increase in physical activity and sport participation.      It is hypothesized that participation will be predicted by sports commitment as per the     tenets of the Sport Commitment Model, and commitment will be predicted primarily by enjoyment     (+), social constraints from family obligations/involvement alternatives (-), followed by     social involvement opportunities/personal investments (+).   "
29596|NCT02898272|"     The SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in     whom the University of Pittsburgh has already obtained baseline and five year data, in order     to enhance bone mineral density and vascular function data collection from minority smokers.     Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density.     Non-invasive vascular studies will be performed to measure endothelial function.     Questionnaires regarding symptoms and activity levels will be administered and a blood sample     will be obtained in participants in which blood samples are not already available from the     COPDGene study visits.   "
29597|NCT02898259|"     A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line     Therapy for High Risk Indolent B cell Lymphoma   "
29598|NCT02898246|"     The aim of the study is to evaluate the psychometric properties of the newly developed Fear     of Activity in Situations - Heart Failure (FActS-HF 15) scale. The FActS-HF 15 is a     questionnaire assessing fear of physical activity (fear of movement) in patients with chronic     heart failure. FActS-HF 15 assesses cognitions and emotions that can occur during physical     activity, independent of avoidance behavior. Firstly, the study aims at evaluating the     instrument's reliability and validity and to investigate associations of fear of physical     activity with demographic, medical, and psychosocial patient characteristics. Secondly, the     study aims at assessing everyday physical activity using accelerometric measures to test the     hypothesis that fear of physical activity in patients with heart failure is related with     lower actual physical activity.   "
29599|NCT02898233|"     The purpose of this study is to better understand how low-level light therapy (LLLT) can be     used to augment the antidepressant effects of Deprexis, an internet-based treatment program     for depression, for participants with current major depressive disorder. The researchers will     administer active and placebo LLLT to the right forehead of participants who show an     improvement of at least 10% in depressive symptoms from baseline after two weeks of Deprexis     treatment.      Hypothesis: Participants who receive active LLLT will show a greater reduction of depressive     symptoms than participants who receive placebo LLLT.   "
29600|NCT02898220|"     The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network     has been established by the National Institute of Diabetes and Digestive and Kidney Diseases     (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the     study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and     Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously     undertaken. Patients with IC or CP are being recruited for a new study called the Trans-MAPP     Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This research study will     recruit Control Participants to better understand the symptoms of individuals with some form     of IC or CP. As with many chronic pain disorders, IC and CP are poorly understood, and     treatment is often not helpful. The goal of this study is to better understand how pain is     felt in people with IC or CP and the investigators hope that this study will lead to     improvement in the treatment of IC and CP.   "
29601|NCT02898207|"     This phase I trial studies the side effects and best dose of olaparib and onalespib when     given together in treating patients with solid tumors that have spread to other places in the     body or cannot be removed by surgery or ovarian, fallopian tube, primary peritoneal, or     triple-negative breast cancer that has come back. Olaparib and onalespib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
29620|NCT02897960|"     Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute     bronchiolitis. One third of these infants will develop recurrent episodes, leading to the     diagnosis of infant asthma. Nowadays, no available treatment shortens the course of     bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our     hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will help     to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of     wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value.     The investigators developed a wheezing recognition algorithm from recorded respiratory sounds     with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of     the present cross sectional, observational study are 1/ to further validate our approach in a     larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint     during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing     by respiratory sound recording (Littmann) and subsequent analysis by two experienced     pediatricians.   "
29679|NCT02897193|"     Horizontal bone augmentation procedures are commonly used to increase bone width to allow the     placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter     implants could be used instead in order to avoid bone augmentation procedures.      The comparison between these two solutions will be evaluated in the trial.   "
29683|NCT02897141|"     The goal of this study is to facilitate the dissemination and implementation of patient     centered outcomes research using mHealth technology to improve self-management of adverse     symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially     important because the US HIV epidemic continues to exact a huge toll, especially among Agency     for Healthcare Research and Quality (AHRQ) priority populations including racial, ethnic, and     sexual minorities and low-income persons. The incorporation of HIV symptom management     strategies into patients' lives through the use of mHealth technologies has the potential to     advance the effective dissemination and implementation of patient centered outcomes research     findings.   "
29602|NCT02898194|"     Background:      Some people cannot make medical treatment decisions on their own. The people who make     decisions on their behalf are called medical surrogates. Sometimes surrogates cannot predict     which treatment course the person or their loved ones would have chosen. The surrogates often     become distressed because of making these decisions. Researchers think a tool called a     Patient Preference Predictor (PPP) may be able to make the process easier. The PPP would     predict what treatment the person would want. This is based on treatment preferences of     similar people in a similar circumstance. Researchers want to interview surrogates to explore     their views on the PPP.      Objective:      To explore surrogates views on incorporating a PPP into shared medical decision-making.      Eligibility:      People 18 years or older who:      Have acted as a surrogate medical decision-maker within the past 3 years. This includes     decisions about      treatment, medication, hospice care, hospital admission, or discharge.      Are not pregnant      Design:      Participants will be screened by meeting with clinicians in person or by phone to discuss the     study.      Participants will take part in a focus group. This is a small group of people discussing     their thoughts and opinions. This will last for about 2 hours.      Participants will be served a light meal.      Participants will provide information about themselves and their views. They will talk about     their past experiences making medical decisions for someone. They will discuss how they felt     about these decisions.      The PPP will be explained to participants. They will give their views on it.      The research team will audio record the focus group and take notes.      Participants will fill out questionnaires.   "
29603|NCT02898181|"     Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is     associated with increased systemic inflammation. Previous studies have demonstrated increased     levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-6     (IL-6), interleukin-10 (IL-10) and Tumor Necrosis Factor alpha (TNFα) in patients with heart     failure (HF). Increased activity of sympathetic nervous system in ADHF is linked to     inflammation. Previous anti-inflammatory drug therapies in HF have demonstrated no     significant impact on cardiovascular outcomes. Low-level vagus nerve stimulation (LLVNS) is a     non-invasive way to modulate autonomic tone and thereby inflammation. Vagal nerve stimulation     is thought to increase the parasympathetic activity and suppress the sympathetic activity.     Clinical studies of vagal stimulation in chronic HF have been negative. Recent experimental     and clinical data suggest that low level tragus nerve stimulation (LLTNS) may produce the     same desired neuromodulator effect compared to LLVNS. It is however unknown if LLTNS in ADHF     will directly lead to a reduction in the levels of pro-inflammatory cytokines (CRP, IL-1,     IL-6 and TNF-α) and an increase in the level of anti-inflammatory marker IL-10.The objective     of this proposal is to determine the impact of LLTS on inflammatory cytokines in patients     with ADHF.      Patients will be randomized to either active or no stimulation(~8 hours daily). Serum     collected will (post admission and on days 2, 3 and 4 post admission) will be used for     cytokine measurement. This investigation will likely establish the first evidence of effects     of LLTS on suppression of inflammation in patients presenting with ADHF.   "
29604|NCT02898168|"     Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in     the daily life of patients. It is considered significant effects on their Quality of     Life(QOL).      Further methods of rehabilitation are required for convalescent patients to recover their     function soon and better, due to a multitudes of recovery patient with troubles such as gait     problem.      This trial is studying to investigate the effects of gait training with a functional     electrical stimulation (FES) `WalkAide[R](WA)' to improve the lower-limb function and     ambulation in convalescent stroke patients.   "
29605|NCT02898155|"     Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To     Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work Unveils     Considerable Geographic Variation In The Rate Of Pah In France And Suggest That Primary Care     Organization Might Play A Role In This Variation. However, A Limitation Of This Work Lies In     The Lack Of Data On Actual Primary Care Utilization.      The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially     Avoidable Hospitalizations At the Zip Code Level, In The French Region     Languedoc-Roussillon-Midi-Pyrénées.      The investigator will implement An Ecological Approach In Which The Geographic Variation In     The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate     Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.   "
29606|NCT02898142|"     Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of     intestinal triglyceride rich lipoproteins in patients with isolated fasting     hypertriglyceridemia.      The objective of this study is to compare the serum apoB48 rate after a standardized load     test, among patients with isolated hypertriglyceridemia and patients with metabolic syndrome.   "
29607|NCT02898129|"     The research question is Are the different types of house in Ho Chi Minh city equally     contributing to chronic respiratory diseases?.      According to this question, a cross-sectional and explorative study was set up to explore the     differences in the environmental characteristics and prevalence of chronic respiratory     diseases among common housing types in Ho Chi Minh city. Preliminary work was performed in     100 houses (20 houses per type, included tube houses, rental houses, rural houses, slum and     apartment) from November 2013 to June 2015. It included measures by environmental devices,     questionnaires and indoor activities diaries.      This study will aim to collect information about the prevalence of chronic respiratory     diseases (CRDs) inside those house types to understand more about role of house types in     developing CRDs.      The objective is:        1. to evaluate the relationships between the type of house and lung function of inhabitants          in each housing type.        2. to evaluate the effects of environmental risk factors in each house type on prevalence          of CRDs   "
29608|NCT02898116|"     This is an open-label, multicenter, single-arm study to evaluate the safety and preliminary     efficacy of a targeted therapy for NSCLC in combination with a checkpoint inhibitor:        -  Ensartinib (X-396), an anaplastic lymphoma kinase (ALK) Inhibitor and        -  Durvalumab (MEDI4736), an anti-programmed cell death ligand 1 (PD-L1) antibody.   "
29877|NCT02894606|"     The investigators expect to better characterise B cell subpopulation and functional     properties early after graft, to analyse effect of induction therapy (thymoglobulin versus     basiliximab) on B cells, and to compare this B cell profiles with those obtained in our     previous study in patients with chronic Antibody Mediated Rejection (cAMR)   "
29609|NCT02898103|"     The moderate-to-severe pain many patients experience following orthopedic surgery is often     treated with opioids, which are associated with side effects such as nausea/vomiting,     sedation, and respiratory depression (and a risk of abuse). Potent site-specific analgesia     with fewer side effects may be provided with a continuous peripheral nerve block, which     involves the percutaneous insertion of a catheter adjacent to the peripheral nerve(s)     supplying a surgical site. Local anesthetic is introduced via the catheter. However, there     are major problems with continuous nerve blocks that have dramatically limited their use     outside academic centers. Percutaneous peripheral nerve stimulation (PNS) or nerve     modulation is an alternative method of pain control involving the insertion of an electrical     lead through an introducing needle—obviating an open surgical incision for placement—followed     by the introduction of electric current to produce analgesia. This modality has been used to     treat chronic pain, but it has not been evaluated with a randomized, controlled study when     applied to acute pain management (post-surgical analgesia). This temporary therapy has     multiple theoretical benefits over existing analgesics, such as a lack of systemic side     effects (e.g., nausea, respiratory depression), an absence of induced muscle weakness, and a     reduced risk of adverse events (e.g. infection). The purpose of the proposed randomized,     double-masked, placebo-controlled, crossover, feasibility study is to explore the possibility     of treating postoperative pain with ultrasound-guided percutaneous PNS and, if so, to help     power a subsequent definitive randomized, controlled trial.   "
29610|NCT02898090|"     This research focuses on the development and validation of indicators on the appropriateness     of oral anticoagulant prescriptions. The investigators want to propose transferable tools to     other healthcare institutions to allow automated construction of indicators as part of a     structured approach to improve future practices. The main objective of the study is to     develop indicators on the appropriateness of oral anticoagulant prescriptions in adult     medicine automated from the hospital information system and to assess their criterion     validity.   "
29611|NCT02898077|"     The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab     in participants with gastric and gastroesophageal cancer.   "
29612|NCT02898064|"     Consenting patients with multiple myeloma (MM) will be randomly allocated to receive either     standard medical treatment (chemotherapy, radiotherapy, pain-killing medication) alone or     standard medical treatment plus a brace. Patients will be regularly evaluated in research     clinics; the results data will inform the design of a full trial. Information will be     collected to inform a list of requirements a centre needs to have in place to run an RCT of     these interventions.   "
29613|NCT02898051|"     Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment     of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a     high risk of recurrent thromboembolism. The high rate of recurrence may result from     alterations in the pharmacokinetics of LMWH. The primary purpose of the study is to compare     the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer     treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism     (VTE). The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and     concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa     activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH     for VTE.   "
29614|NCT02898038|"     Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS   "
29615|NCT02898025|"     This study aims to evaluate the effectiveness of the low level laser therapy and     interferential current in 168 patients with knee osteoarthritis   "
29616|NCT02898012|"     The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a     Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the     efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70     years and a KPS <70.   "
29617|NCT02897999|"     The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of     single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult     volunteers   "
29618|NCT02897986|"     Cancer remains the first cause of death due to disease in children and adolescents despite     important progress and 70% of the survivors present sequelae. It is therefore mandatory to     generate new and preferably less toxic treatment strategies relying on new anticancer agents,     and/or new combinations or schedules of administered compounds.      Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a     daily/weekly basis. MC has been showed to be a safe and effective way to administer     chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects.      Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have     been unveiled. Propranolol is a non selective beta-blocker initially used to treat     hypertension but recently its anticancer properties have been discovered. The place of     Betablockers as anticancer agents is supported by both preclinical and epidemiologic data.     The investigators have showed that the use of betablockers could sensitize breast cancer,     angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an     anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively     their potential in adults with cancer but none in children so far.      The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral     metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a     rolling six design and a dose escalation with thrice weekly oral vinorelbine only plus     addition of daily oral propranolol after completion of the first cycle. PK analysis of     vinorelbine and propranolol will be performed. Once the recommended dose of the combination     established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as     beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be     evaluated.      This will provide a well tolerated, all oral combination for patients with     refractory/relapsing tumours. This combination could also be then proposed as a maintenance     for instance in patients with rhabdomyosarcoma or neuroblastoma.   "
29619|NCT02897973|"     The prevalence of low back pain among persons with unilateral lower limb amputation is     significantly higher than the rate experienced by the general public. Chronic pain, including     low back pain, limits functional independence and negatively impacts quality of life. As     such, this project will investigate the role of a biomechanical casual pathway in the     development of low back pain; to do this, the investigators will explore the relationship     between the adopted neuromuscular patterns post-amputation to perform activities of daily     living and the risk of developing spinal tissue damage.   "
29663|NCT02897401|"     Multicenter, national study, non-randomized , controlled, comparative with 4 independent     groups (20 participants in each group). There are 3 experimental groups (smocker, nicotine     replacement therapy an electronic cigarette) and 1 control group (without nicotine).      The main objective of the study is to compare the level of urinary NNN in the electronic     cigarette users versus the nicotine replacement therapy (patch) users.   "
29621|NCT02897947|"     There is no international consensus on evaluation and surgical treatment of Lumbar Spinal     Stenosis (LSS). The indication for operative treatment is relative, and the variation in     surgical rates and procedures is significant, both within and between countries.     Understanding practice-based variety is critical since these differences may reflect a     disparity in quality of the health care in different institutions, regions, or countries.     Norway, Sweden, and Denmark do all have National spine registers for research and quality     assessment. Comparing indications for surgery, selected procedure, patient reported outcomes,     and factors predicting outcome after surgery for LSS between these countries could provide     information about optimal indications and strategy for surgery. Register-based studies have     advantages such as large sample sizes and high external validity, but also limitations such     as lower follow-up rates, and inferior data quality compared to clinical trials.      Hypotheses: Between these three countries, there are no differences in (i) indications for     surgery, (ii) patient-reported outcome after surgery or (iii) risk factors associated to     outcome are similar.   "
29622|NCT02897934|"     The objectives of this work are threefold:        1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major          breast cancer surgery        2. To evaluate objective indices of patient recovery following anaesthesia and surgery in a          23 hour model of care        3. To evaluate patient satisfaction with their care pathway   "
29623|NCT02897921|"     Many myopathies are inherited in a recessive manner, but in some of these recessively     inherited disorders, clinical manifestations may potentially manifest in carriers of just a     single mutation.      The aim of the study is to describe the clinical characteristics of single mutation carriers     of recessive myopathy, through measuring serum creatine kinase, muscle strength, muscle     degeneration (by MRI) and heart affection. The investigators will do this by blood sampling,     Biodex 4 Isokinetic Dynamometer, MRI analysis, ECG, Holter monitoring, and echocardiography.      The aim is further to describe whether these characteristics are found primarily with     specific mutations.   "
29624|NCT02897908|"     The primary goal of this study is to establish a database of people with varying levels of     hepatic fibrosis and various etiologies of liver disease for use in future research     protocols.   "
29625|NCT02897895|"     The study is an interventional, multicentre, prospective, randomized, controlled,     single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin     (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant     center and according to the underlying lung disease (affected with cystic fibrosis or not)     and will be randomized to either evaluation of calcineurin activity (CN-a) in combination     with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to     compare the proportion of acute rejection that has required a specific curative treatment at     6 months after transplantation between patients in the two groups.   "
29626|NCT02897882|"     The objective of this project is to estimate the frequency and the characters of the chronic     pains by a follow-up which begins during the registration on the waiting list of transplant     and which ends at the end of the third year following the lung transplantation. It is a     forward-looking study of prevalence entering within the framework of the common care. After     lung transplant, pain will be evaluate with questionnaires every day during the     hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.   "
29627|NCT02897869|"     Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study.     Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or     combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects.     The study consists of an eligibility screening period, up to 3 treatments periods and a     follow-up visit.   "
29628|NCT02897856|"     The goal of this study is to prove that intramuscular midazolam is more effective than buccal     midazolam in cessation of seizure activity with comparable side effects.   "
29629|NCT02897843|"     Electroconvulsive therapy (ECT) is an effective treatment for a variety of psychiatric     disorders. However, despite continued advances in ECT technique, neurocognitive dysfunction     continues to be a frequent adverse effect. Declarative memory and less so selective memory     are often impaired after an ECT course. Immediate memory, however, is broadly preserved. It     is hypothesized that memory impairments are due to ECT induced disruptions on long term     potentiation as well as in cerebral flux and glutamatergic and cholinergic systems. Different     pharmacological agents for the treatment of ECT induced cognitive dysfunction have been     tried. Agents such as opioids, vasopressin, neuropeptides, cholinergic agents, thyroid     hormone, and stimulants have been used with equivocal results, and no controlled studies     showed clear efficacy.      Transcranial direct current stimulation (tDCS) is a non-invasive, painless brain stimulation     treatment that uses direct electrical currents to stimulate specific parts of the brain.     Electrical currents are applied constantly at low intensities (1-2 mA) over a long period,     usually in minutes (5-30 minutes), to achieve changes in cortical excitability by influencing     spontaneous neural activity. There are two types of stimulation with tDCS: anodal and     cathodal stimulation. Anodal stimulation acts to excite neuronal activity while cathodal     stimulation inhibits or reduces neuronal activity. Several studies demonstrated moderate to     strong effect sizes of tDCS in various neurocognitive and neuropsychiatric settings. Majority     of studies show positive effects of tDCS on cognitive functioning among healthy volunteers     and subjects with neurological or psychiatric conditions. Beneficial effects of online     stimulation applied over the left dorsolateral prefrontal cortex have been reported for     working memory, attention and information processing in depressed patients. To the     investigators' knowledge no studies have evaluated the potential efficacy of tDCS for the     prevention of ECT induced cognitive adverse effects.      In the current study, the investigators propose a double blind, randomized controlled trial     to test the use of tDCS as a strategy to prevent or mitigate the memory impairments     frequently associated with an ECT course.   "
29630|NCT02897830|"     Open-label study to evaluate the safety and efficacy of Ixazomib in combination with     Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The     patient population will consist of adult men and women up to 65 years, who have a confirmed     diagnosis of MM who meet eligibility criteria.   "
29631|NCT02897817|"     The aim of this study is to evaluate, at 6 months, the rate of patients whose adherence to     injectable MTX remained strong or improved according to patient-reported outcome.   "
29664|NCT02897388|"     To assess the prevalence of breast milk feeding in a NICU in China, to implement a quality     improvement program to increase breast milk feeding, and to evaluate its impact.   "
29680|NCT02897180|"     The use of a supplement food like Nyaditum resae is a reliable opportunity to stop the     progression towards active TB through the most updated knowledge of this disease:the     induction of tolerance.      In order to demonstrate the percentage of efficacy of this approach, different studies must     be run to elucidate the percentage of protection in different setting all over the world. The     strategy is to establish its efficacy through a simple clinical trial, aimed just to know the     incidence of TB in Placebo and NR treated contacts of active TB cases.   "
29632|NCT02897804|"     The overall objective of the proposed research is to reduce the incidence of sexually     transmitted infections (STIs) among college students. The investigators propose to accomplish     this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to     develop a highly effective, appealing, economical, and readily scalable internet-delivered     behavioral intervention targeting the intersection of alcohol use and sexual risk behavior.     The rate of STIs on college campuses is alarming: one in four college students is diagnosed     with an STI at least once during their college experience. Sexual activity when drinking     alcohol is highly prevalent among college students. Alcohol use is known to contribute to the     sexual risk behaviors that are most responsible for the transmission of STIs, namely     unprotected sex, contact with numerous partners, and hook-ups (casual sexual encounters).     Few interventions have been developed that explicitly target the intersection of alcohol use     and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of     STI transmission among this and other high-risk groups, a new approach is needed. MOST is a     comprehensive methodological framework that brings the power of engineering principles to     bear on optimization of behavioral interventions. MOST enables researchers to experimentally     test the individual components in an intervention to determine their effectiveness,     indicating which components need to be revised and re-tested. Given the high rates of alcohol     use and sex among college students, the college setting provides an ideal opportunity for     intervening on alcohol use and sexual risk behaviors. The proposed study will include a     diverse population of college students on 4 campuses which will increase the generalizability     of the findings. The specific aims are to (1) develop and pilot test an initial set of online     intervention components targeting the link between alcohol use and sexual risk behaviors, (2)     use the MOST approach to build an optimized preventive intervention, and (3) evaluate the     effectiveness of the newly optimized preventive intervention using a fully powered randomized     controlled trial (RCT). This work will result in a new, more potent behavioral intervention     that will reduce the incidence of STIs among college students in the US, and will lay the     groundwork for a new generation of highly effective STI prevention interventions aimed at     other subpopulations at risk.   "
29633|NCT02897791|"     Main idea perception of written stories and in pictures among impaired right hemisphere     patients Abstract The right hemisphere is considered to complement the language processing     abilities of the opposite hemisphere; it is responsible for the processing of secondary and     unusual characteristics of linguistic stimulates. This processing enables, among other     functions, the comprehension of metaphors and humor. Additionally, it enables the execution     of inferring from spoken and written discourse. Studies which deal with common impairments     among right-hemisphere-damaged (RHD) individuals, found that inference processing of written     stories and narrative sequences presented in pictures was impaired. This impairment could     damage the ability to create global coherence, which is an important component of central     theme comprehension of different types of narrative. Another important component is     superstructures, schemas which aid creating, remembering and producing the main ideas of     spoken and written discourse. Other studies consider impairment in creating global coherence,     or Theory of Mind impairment, as the source of central theme comprehension impairment among     RHD individuals.      Discourse is an integral part of interpersonal communication, and of proper social conduct.     The themes chosen for conversation reflect the functional role of discourse from semantic and     pragmatic points of view.      The aim of the current study is to deepen the current knowledge concerning central theme     comprehension among RHD individuals following cerebrovascular accident (CVA), in two genres     of written discourse (classic stories and stories with a twist), and in situations     represented by single pictures. Unlike written stories, the extraction of the central theme     out of a single picture requires focusing on a single situation and relying on non-linguistic     visual information. Differences concerning central theme comprehension in the different     discourse genres and in the pictures might be able to assist in selecting diagnostic and     therapeutic tools designed to work on high cognitive-linguistic abilities, which are usually     impaired among RHD individuals. In later stage, these tools are meant to help improving RHD     individuals' spontaneous narrative skills.      The study will include 20 RHD adults following CVA, and 20 healthy adults without any known     damage to the right hemisphere. The two groups will be matched concerning sex, age,     educational level and socio-economic status. The subjects will perform the study tests during     three sessions, 60 minutes each. The screening tests will include language diagnosis -     Western Aphasia Battery (WAB), and reading test no. 37 included in the Psycholinguistic     Assessments of Language Processing in Aphasia's battery (PALPA). Patients diagnosed with     aphasia will be excluded from research. The research tests will include: central theme     comprehension test in stories and pictures, including classic stories, stories with a twist,     and pictures of different situations (each will be accompanied by a multiple-choice question     concerning the central theme), sub- exanimations taken from Frigbi battery designed to     evaluate memory and phonological memory capacity, Raven's Progressive Colored Matrices test     designed to evaluate pre-morbid abilities (non-linguistic), Theory of Mind (T.O.M) evaluation     test, and tests designed to evaluate central coherence impairment: Navon Figures test for     evaluation of global visual perception impairment, and Rey-Osterrieth Complex Figure Test     (RCFT) - Recall Form test for evaluation of visual-perceptive organizational ability, and     non-verbal memory. The performances of the two groups will be compared in each test using     statistical tests. In addition, the interaction between all variables will be measured.   "
29634|NCT02897778|"     The purpose of this study is to evaluate the effect of entinostat on heart rate and other     electrocardiogram parameters. This study will also evaluate the safety and tolerability of     entinostat, as well as pharmacokinetic and pharmacodynamic parameters.   "
29635|NCT02897765|"     The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in     combination with nivolumab is safe and useful for patients with certain types of cancer. The     study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a     substantial improvement over other available therapies such as nivolumab alone. All eligible     patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.   "
29636|NCT02897752|"     RATIONALE:      The previous study resulted that the gait training using Functional Electrical Stimulation     (FES) improved the ankle joint function and the walking ability for the chronic stroke     patients with foot drop.      In addition, the further exploratory study in multicenter obtained the result that the     training with WA were especially good adaptation to the patients who have slight paralysis     and can walk independently.      PURPOSE:      This multicenter prospective trial is studying to reveal whether the gait training with the     WalkAide[R](WA) for chronic stroke patients who can walk independently is superior to gait     training with a physical therapist.   "
29637|NCT02897739|"     Tako Tsubo Cardiomyopathy (TTC), also known as Broken Heart Syndrome, is a disorder of the     heart that occurs most commonly in women (although it occasionally occurs in men) and is     usually related to a stressful event. Symptoms are often similar to a heart attack, and     include chest pain and shortness of breath. Although Tako Tsubo Cardiomyopathy is not a new     medical condition, it has not been widely recognised until the last decade. Currently the     investigators don't have an exact understanding of how or why the heart is affected in this     way, and so the investigators are conducting a study to help understand what causes Tako     Tsubo Cardiomyopathy.   "
29638|NCT02897726|"     The purpose of this study is to evaluate and compare the safety and pharmacokinetics of     NVP-1402 and NVP-1402R in healthy male subjects.   "
29639|NCT02897713|"     Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse     outcome. According to guidelines released from authority organizations, enteral nutrition     (EN) should be prior approach for critically ill patients. However, initiation and delivery     of EN during the early period of ICU admission are frequently hampered, which results in     underfeeding. The investigators speculate whether an intensive enteral nutrition strategy     could reinforce the delivery of EN thereby improving outcomes. In this multi-center,     prospective, randomized parallel clinical trial, the investigators aim to assess the     feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated     patients.   "
29640|NCT02897700|"     The overarching purpose of this study is to determine if the mainstay chemotherapeutic     regimens represented by several genotoxic agents including but not limited to     Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the     format of either a single agent or combinations are safe, tolerable, and effective in the     treatment of patients with infiltrating ductal carcinoma of breast.   "
29641|NCT02897687|"     Twelve participants were randomized to either a Facebook group or a book club group for six     weeks. Data was collected on the participants social and behavioral function at both the     start and the conclusion of the intervention.   "
29642|NCT02897674|"     Aims: To investigate whether diet with realistic doses on palm oil will have an effect on     lipid profile and fat deposition in healthy volunteers.      Design: Randomized, parallel design over 14 weeks including a 2 week standardization period     and 12 week supplementation. In the standardization period all participants will incorporate     palm oil into their diet which will make up 20% of their calories providing a baseline     measure. In the supplementation period of 12 weeks, each volunteer will be randomized into     one of the three fats: palm olein, interesterified palm olein or soybean oil, consuming 20%     of their calories from these fast and remaining 10% fat calories from fats naturally     occurring in foods like meat and nuts. Otherwise participants will keep the rest of their     diet habitual.      Population: 60 healthy males and females aged between 18 and 60 years, of which 30     participants with a BMI between 18.5-24.9kg/m2 and 30 participants with a BMI between     25-29.9kg/m2 and fasting plasma glucose and no evidence of insulin resistance will be     recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of     diabetes, hypertension or hyperlipidemia.      Treatment: Pre-intervention: Participants will be asked to record habitual dietary intake by     completion of a 4-day food diary and be asked to wear an accelerometer armband to assess     physical activity at the beginning and at the end of supplementation period.      2 weeks standardization period: All participants will be asked to replace added fat in their     diet with palm olein providing two thirds of 30% fat calories.      At the end of the standardization period, which will be the first day of a 12 week dietary     intervention, as well as at the end of 12 week supplementation, participants will attend the     clinical research facility for a study visit. Weight, height and waist circumference will be     taken; total and regional body composition will be measured by MRI. Fasting and post prandial     plasma glucose, insulin, appetite hormones and lipids will be measured. Participants will be     asked to come in for follow-up visits at week 6 and 10 for a single blood samples and weight     check.      12 week supplementation period: participants will be randomized into one of the three     supplementation groups: palm olein, interesterified palm olein or soybean oil. Participants     will be asked to consume two thirds of their 30%fat calories from one of the oils while     incorporating it into their normal diet in cooking and baking.   "
29643|NCT02897661|"     Patients with Crohns' disease are always complicated with malnutrition. This trial aimed to     assess whether FMT accompanied by enteral nutrition (EN) can make contributions to patients     with Crohns' disease.   "
29677|NCT02897219|"     The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c     and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once     daily in combination with insulin for 24 weeks. This study will also assess the     safety/efficacy of long-term treatment (52 weeks).   "
29644|NCT02897648|"     The route of subcutaneous administration of drugs has become a common practice in some     specialties (palliative care, geriatrics).      This is an alternative to oral, sublingual, rectal or intravenous Many drugs are used by     subcutaneous route but few clinical studies evaluating the level of scientific relevance     justifies their use.      The purpose of this study is to assess:        1. / Determine that there is no difference between the subcutaneously compared to          intravenous administration in terms of dosage and serum PK / PD of Beta lactam          objectives in a geriatric population.        2. / The safety and lack of toxicity of administrations subcutaneously.      Advantages disadvantages        -  easy Of establishment        -  Simplicity Monitoring and manipulation        -  Reduced Risk of infection        -  No Risk of venous thrombosis        -  Lower cost Simple -Technique for support at home taking        -  Limitation Aggressive gestures        -  multiplicity Of all possible injection sites        -  Technique Of choice for agitated patients or confused -Risk of localized edema (<1000mL          / 24 / site)        -  Use Impossible for some drugs        -  Risk Discomfort and intolerance at the injection site      A practical study was conducted among 382 physicians (289 geriatricians and 93 infectious     disease specialists). Among them 97.5% reported regular use of the subcutaneous route for the     administration of antibiotics.      Declarative criteria pretend curb the use of this route was the lack of data Pk / Pd (61.2%);     the absence of marketing authorization for the subcutaneous route (34.5%); the absence of     serum assay available (2.1%).   "
29645|NCT02897635|"     The purpose of this study is to develop and test a 12-month Integrative Medicine intervention     based on Ayurvedic medicine in recent breast cancer survivors.   "
29646|NCT02897622|"     Patients with severe and enduring eating disorders (SEED) are seriously ill and have a low     quality of life. In 2014, a special unit based on case management (CM), for patients with     SEED (the Eira unit) was started at Stockholm Centre for Eating Disorders, Sweden. Eating     disorder is a serious illness that creates a great deal of suffering. Most patients who     undergo specialized eating disorder treatment will be healthy, but a small percentage of the     patients develop a SEED. SEED patient have gone through numerous of treatments and has been     to several specialists units for years as well as they has completed many different therapies     without getting fee from the eating disorder (ED). Due to the long term sick in ED the SEED     patient is often alone and has difficulties to cope with everyday life situations. SEED     patients are a vulnerable patient population with a great suffering and poverty to release     the identity of the ED. However, no previous study is done in which patients with SEED     themselves describe their own theory about why they are still ill and how specialized eating     disorder care has affected them. In the ED field, there is a growing consensus that treatment     of patients with SEED needs to be multi-professional, with a focus on improving the patients'     social situation, minimizing medical complications, and enhancing quality of life and     independence, rather than focusing one-sided on symptom reduction. Is case management a way     to help the SEED patients witness a better quality of life? Besides the personal suffering of     patients and their families, SEED is also associated with high costs for health care and for     society in general.   "
29647|NCT02897609|"     3rd generation cephalosporins (C3G) are the antibiotics recommended in probabilistic in most     enteric infections in France including pyelonephritis and bacteraemia.      However, the prevalence of resistance of Enterobacteriaceae including E. coli to C3G is     continuously increasing for several years. In 2012, in France, the proportion of E. resistant     or intermediate coli categorized to C3G is 10 to 25% (EARSS data).      Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for     patients in terms of morbidity and mortality and unnecessary prolongation of the DMS.      At St. Joseph's Hospital on enterobacteria levels of resistance to C3G is 15.4%.      To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe     antibiotics adapted to the resistance of the bacteria, it is interesting to use a rapid test     for detection of resistance to C3G.      The Lacta ™ test could be used in this indication. This is a rapid test diagnostic     orientation detecting hydrolysis of a substrate (chromogenic cephalosporin) by the enzymatic     action of ESBL, cAMP-type cephalosporinases and carbapenemases. This test was initially     marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial     colonies in culture.   "
29648|NCT02897596|"     Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic     Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of     Grazoprevir + Elbasvir in HIV-HCV co-infected patients.   "
29649|NCT02897583|"     This is a single-center, prospective randomized controlled trial evaluating the safety and     efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous     detachment.   "
29650|NCT02897570|"     This study aims at assessing the effects of glucose and different types of breakfast on     metabolic and neurofunctional responses in healthy individuals.      Twelve healthy subjects, on a stable diet, in a randomized-crossover fashion, received either     a 50 g glucose load (control) or one of these breakfast:      B1: milk (125ml) and cereals (30g); B2: milk (220ml), apple (200g) and cream chocolate filled     sponge cake (30g); B3: milk (125ml), bread (50g), apple (150g) and hazelnut cream chocolate     (15g). Prior and upon completion of each tolerance test, an EEG was performed to measure     frontal P300-evoked potentials.   "
29651|NCT02897557|"     The purpose is to perform an early investigation on the safety and performance of an     Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and     gather clinical data that will be used to make improvements or modifications to the algorithm     for subsequent studies in adults, adolescents and children with type 1 diabetes.   "
29652|NCT02897544|"     The purpose of this study is to develop and test a 6 month manualized Health Education     intervention in recent breast cancer survivors.   "
29653|NCT02897531|"     The purpose of this study is to evaluate the efficacy of end-to-side anastomosis after     laparoscopic right hemicolectomy compared with that of side-to-side anastomosis. The     investigators hypothesize that the end-to-side anastomosis may be associated with superior     recovery compared with side-to-side anastomosis after laparoscopic right hemicolectomy under     enhanced recovery program. The primary endpoint is the cumulative recovery rate, consisting     of the recovery time of diet, pain, ambulation, and afebrile status.   "
31157|NCT02877927|"     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared     to linezolid in the treatment of adults with acute bacterial skin and skin structure     infections.   "
29654|NCT02897518|"     The primary end point of this study is the feasibility of intubation. The secondary     end-points are the success to intubate in the first attempt, the intubation time, the Cormack     and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the     need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and     Glidescope®.      Patients admit to the operation rooms of University of Naples Federico II and requiring     endotracheal intubation for general anesthesia will be consecutively screened for the     presence of predicted difficult airway according Italian guideline. According to this     guideline, the presence of one or more of the following parameters may be considered highly     predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm,     mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior     incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced     mental-jugular distance. Patients matching more then 1 of the previous criteria stated by     Italian guideline will be included in this case controlled study. Patients 1) without     criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18     years; or 4) declined consent to participate, will be excluded from this study.The primary     end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary     end-points were the learning curve, the intubation time, the Cormack and Lehane score view,     and the need for maneuvers to aid the endotracheal intubation comparing different     videolaryngoscopes available in our department. Two anesthesiologists with 10 years of     experience in conventional endotracheal intubation and trained for video assisted intubation     will perform the maneuvers.   "
29655|NCT02897505|"     Women will be recruited from the EMPOWER clinic when they present for care; they may be given     a flyer as part of their clinic entry paperwork, or approached by a study staff member in the     waiting area of the clinic. Women who are clients of Sanctuary for Families may find out     about the music workshops and the study through Sanctuary for Families staff, who will post     flyers in their noticeboards or offices.      This study will use a repeated measures survey design to evaluate the effect of a musical     workshop intervention to aid in the management of mood, anxiety, and stress among women     enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence.     Assessment of the feasibility and acceptability of this music intervention will be carried     out on participants as they are taught to manage stress and emotions.   "
29656|NCT02897492|"     Patients with chest pain may have postponed or missed diagnosis of acute coronary events due     to relatively late detection of troponin elevation. The study will investigate a new     diagnostic method for early detection of even minimal troponin elevation in patients admitted     with chest pain.   "
29657|NCT02897479|"     This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per     day(QD) to locally advanced/metastatic PSC patients with MET Exon 14 mutation. The targeted     population is the patients with MET Exon 14 mutation who have failed prior systemic therapy     (ies), or are unwilling or unable to receive chemotherapy. Pathological diagnosis will be     confirmed retrospectively by the central pathological laboratory.   "
29658|NCT02897466|"     Inappropriate antibiotic therapy in ventilator-associated pneumonia (VAP) is associated with     increased mortality. The international guidelines recommend using broad spectrum     antimicrobials especially in patients who received previous antimicrobials, with risk factors     of muti-drug resistant (MDR) VAP or after 5 days of mechanical ventilation. Using     broad-spectrum antibiotics for 48h until the results of conventional cultures and     antimicrobial susceptibility testing (AST) are available, may promote the emergence of     drug-resistant bacteria. Exposure to imipenem, as short as 1 to 3 days, is associated with a     5-fold increase in the risk of imipenem resistance in the gut microbiota of ICU patients     (Armand-Lefevre AAC 2013). Performing AST directly on clinical respiratory samples would     hasten the process by at least 24h.      The diagnostic performance of a rapid method combining mass spectrometry and direct AST     [DAST] are previously analyzed, and compared it with the conventional method (mass     spectrometry with conventional AST [CAST]) and its potential impact was assessed on     antimicrobial use in 85 patients (Le DORZE M et al - Clin. Microbiol. Infect. 2015).      The results produced by the dast were useable in 85,9% of the cases and the sensitivity and     negative predictive values of DAST were 100% for all antibiotics tested, except gentamicin     (97.1% [95%CI = 93.3-101] and 97.4% [93.7-101], respectively) and amikacin (88.9% [81.7-96.1]     and 96.4% [92.1-100.7], respectively), compared with CAST. Specificity and positive     predictive values ranged from 82.9 (74.2-91.5) to 100%, and from 86.4 (78.5−94.2) to 100%,     respectively. If results had been reported to the clinicians, that DAST would have saved     carbapenem prescription in 17 cases (22%) and would have allowed immediate narrow spectrum     antimicrobials in 35/85 (41.2%) cases. But, the benefit of DAST was based on a simulation and     should be now tested in a randomized fashion. This project is a prospective multicenter     study. The hypothesis is that, DAST compared to CAST, would increase the number of adequate     antimicrobial therapy within 24 hours in case of late VAP (> 5 days under mechanical     ventilation) with Gram negative bacilli (GNB) in IC patients while sparing carbapenems     (imipenem and meropenem). The primary objective is to determine the impact of a strategy     using DAST on the rate of day1 adequate therapy without carbapenems in case of late VAP due     to GNB.   "
29659|NCT02897453|"     This study is an opportunity to gather long term safety and efficacy information from     patients who have had their scoliosis treated via anterior vertebral body tethering (VBT).   "
29660|NCT02897440|"     A prospective cohort study to compare full repairing and partial repairing of soft tissue     surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip     function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty     through an anteriorolateral approach were screened for inclusion. Patients with altered     mental status SPMSQ <7, pathological fractures, non-walkers were excluded.   "
29661|NCT02897427|"     There are 2 parts in this study: pre-screening and the main clinical research study.      The goal of the pre-screening part of this study is to learn if participant has antibodies     against human papillomavirus (HPV). Antibodies are created by the immune system and may     attack foreign cells or diseased cells, such as HPV.      The goal of the main study is to learn about the relationship between HPV and cancer risk in     men who test positive for HPV antibodies. Researchers want to look for early methods of     screening for certain types of cancer.      HPV infections can lead to oropharyngeal (throat area), anal, and/or penile cancer. The goal     of the entire study is to learn if screening for HPV can help doctors learn which patients     may be at a higher risk for developing these types of cancer.   "
29662|NCT02897414|"     In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk     evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA)     opioid medications was necessary to support national efforts to reduce serious adverse     outcomes resulting from opioid abuse. This study will evaluate trends before and after the     ER/LA REMS implementation for changes in mortality rates associated with prescription opioids     utilizing state medical examiner databases from multiple states. Databases from 2005 through     the most recent year available will be obtained.   "
29669|NCT02897323|"     The incidence of congenital heart disease is about 8 per thousand live births. Thanks to     advances in cardiac surgery, 90% of children born with heart defects reach adolescence and     adulthood. Congenital heart defects are the leading cause of heart disease in young adults     and expectant mothers in Western countries. The number of patients increases continuously as     life expectancy increases. An increasing number of patients with complex heart defects     survive to adulthood. The medico-surgical management of this highly specialized growing     number of patients is difficult and requires a multidisciplinary collaboration. In France, an     estimated 200,000 patients the number of carrier patients with congenital heart disease. Half     of them will require monitoring, medical procedures, catheterizations and/or surgical     re-intervention. No objective demographic data are currently available on the French     patients. So, the investigators decided to set up an epidemiological project to better     understand this cohort of patients. The main objective of this project is to obtain accurate     epidemiological data needed to adapt the supply of care.   "
29670|NCT02897310|"     This study assess the vital status, renal function and renal recovery of patients admitted to     intensive care unit and requiring renal replacement therapy for acute kidney failure. Patient     follow up is up to 3 years after ICU admission when possible.   "
29671|NCT02897297|"     All patients diagnosed or followed in Brest University Hospital for Philadelphia negative     MPNs will be included in this observational study.      MPNs recorded included: polycythemia vera (PV), essential Thrombocythemia (ET) and Primary     Myelofibrosis (PMF).      This is a not interventional study. Alive patients need to sign a non-opposition consent     form.      Patients will be followed until last news (death, change of reference centre...).   "
29672|NCT02897284|"     Burnout Syndrome is one of the major challenges for health systems worldwide. This study     strives to evaluate the feasibility and effectiveness of an 8- versus 2-week     mindfulness-based self-care program on burnout symptoms and psychological and biological     variables.   "
29673|NCT02897271|"     The purpose of this study is to investigate features of patients with Eosinophilic     Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including     Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis     (EC).   "
29674|NCT02897258|"     The study T2HD Thrombosis and Haemorrhage in chronic hemodialysis patients is a study of     pharmacoepidemiology observational, retrospective cohort, multicenter including 12 dialysis     centers for adults Lorraine.      The main objective is to :      Describe the prescribing practices of drugs anticoagulants and antiplatelet agents in chronic     hemodialysis patients in the Lorraine region.      The second objective is to :      Study the impact of these practices on the survival and the occurrence of major clinical     events, thrombotic and hemorrhagic.   "
29675|NCT02897245|"     Treatment of Chronic Myeloid Leukemia (CML) has been revolutionized by the use of tyrosine     kinase inhibitors including imatinib mesylate (Gleevec, Novartis Laboratories). Two other     inhibitors of the BCR-ABL kinase are currently on the market in France, nilotinib (Tasigna®,     Novartis Laboratories) in the first and second-line treatment and dasatinib (SPRYCEL®,     Bristol-Myers Squibb Laboratories) in second line. Achieving a complete molecular response     (CMR) in patients with Chronic Myeloid Leukemia (CML) treated with tyrosine kinase inhibitors     may be currently regarded as the ultimate level of reduction of residual disease. The pilot     Stop Imatinib study has opened the way for a french prospective study of stopping imatinib,     the STIM study. The results of the STIM study showed that almost 60% of patients exhibited     molecular relapse, most frequently within the first 6 months after discontinuation. The     parameters that are statistically associated with the loss of complete molecular response are     the Sokal score at diagnosis and the total duration of treatment with imatinib. Criteria to     define molecular relapse in treatment free remission patients are not well defined and     validated. The aim of the study is to validate the loss of major molecular response as a     robust criteria for TKI resumption. The patient's population will be CML patients who are     offered to discontinue therapy outside the STIM strial.   "
29676|NCT02897232|"     This is a minimal risk, anonymous, convenience sample, social behavioral study using     qualitative descriptive survey methods. It is to ascertain community member, physician,     resident and medical student perspectives regarding Human Papillomavirus (HPV) infection,     associated diseases and to identify barriers which prevent these groups from ensuring that     males 9-26 receive the three-shot vaccine series to prevent HPV infection.      The research is focused on these questions:      Do community members understand the ease of transmission of the HPV virus in males 9-26? Do     community members, physicians, residents and medical students have knowledge of the     associated diseases that may occur with the HPV virus infection in males age 9-26? Do     community members, physicians, residents and medical students know the ages in which males     should receive the HPV vaccine three-shot series? What barriers prevent community members and     physicians, residents and medical students from ensuring that males 9-26 receive the     three-shot vaccine series to prevent HPV infection?   "
29681|NCT02897167|"     The study of immune pathways involved in the etiopathogeny of schizophrenia would be an     important advance to understand the mechanisms involved in the development of this disease     and it would be a turning point in drug therapy. Until now, the mechanism of action of     antipsychotics focused on the blockade or modulation of brain dopaminergic pathways. If     immunological pathways responsible for neuroinflammation and neurodegeneration which involve     alterations in different areas and brain pathways (including dopaminergic pathways) are     discovered, investigators could develop new treatments that act on these new targets,     allowing to delay the onset of the first psychotic episode and improve the evolution and     impact of this disease.   "
29682|NCT02897154|"     The objective of this study is to compare the performance of two i-STAT Analyzers in a     Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test     glucose, hematocrit and sodium on capillary specimens.   "
29684|NCT02897128|"     Wound complications after sarcoma resection are frequent and potentially devastating problem.     The burden of surgical wound complications in the lower extremity after preoperative external     beam radiation therapy (EBRT) for soft tissue sarcoma is estimated at 43%. A noninvasive     method of predicting complications would be extremely beneficial. The aim of this study is to     evaluate the relationship between preoperative skin oxygenation and wound outcomes in a     multi-center prospective analysis. This information could lead to a change in practice     regarding surgical timing and adjunctive interventions to improve wound healing outcomes.   "
29688|NCT02897076|"     Extensive animal studies have indicated that antenatal betamethasone exposure results in     altered developmental trajectories of several fetal systems. Follow up of a randomized     controlled trial has shown that antenatal betamethasone exposure might result in insulin     resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have     clearly demonstrated that betamethasone-induced growth alterations were dose-related.      In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung     function, similar to those obtained after a full dose.      Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the     potential long term effects of this drug, is not inferior to a full dose to promote fetal     lung maturation in Humans.   "
29689|NCT02897063|"     The purpose of this study is to learn more about the effects of midodrine and droxidopa, two     medications used for the treatment of orthostatic hypotension (low blood pressure on     standing), on the veins of the abdomen of patients with autonomic failure. The study will be     conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2     testing days. The total length of the study will be about 5 days. About 34 participants will     be screened for the study.   "
29690|NCT02897050|"     This multi-center, open-label, phase II randomized controlled trial is to evaluate the     efficacy of docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX)     followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC as     neoadjuvant chemotherapy in treating women with triple negative breast cancer (TNBC), and to     study the anti-tumor immune effect of metronomic neoadjuvant chemotherapy. 186 stage M0 TNBC     patients who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging     are randomly enrolled to receive neoadjuvant T combined with mCX (3 cycles) followed by FEC     (3 cycles) or T (3cycles) followed by FEC (3 cycles) before surgery. The primary end point is     pathological complete response (pCR) rate, and the secondary end points include: clinical     response rate, toxicities, breast-conserving rate, Ki67 and CD31 reduction rate, changes in     the percentages of peripheral blood or tumor microenvironmental regulatory T cells (Treg), T     helper cells (Th), CD8+ T cell, and tumor-specific CTL, and changes in tumor     microenvironmental immune cytokines. Once there is a significant statistical difference in     terms of pCR rate between two groups, 3-year disease-free survival (DFS) and 3-year overall     survival (OS) will be included in the secondary end points. The aims of this study are to     determine whether the neoadjuvant T combined with metronomic CX followed by FEC can     significantly increase the pCR rate in TNBC with acceptable toxicity, and to explore the     anti-tumor immune effect of metronomic neoadjuvant chemotherapy.   "
29691|NCT02897037|"     The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI     patients with DES.      This is a prospective, randomized, single-blind, active drug controlled multicenter clinical     research and the study would enrolled a total of 380 AMI patients undergoing percutaneous     coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or     unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.   "
29692|NCT02897024|"     The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy     treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High     intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks.     In comparison, usual weekly is considered standard of care; although both dosing models are     used clinically for children with CP.   "
29693|NCT02897011|"     To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves     the vaccination response to a seasonal influenza.   "
29697|NCT02896959|"     Postoperative surgical pain has been extensively study with regard to anaesthesia pain     modalities, however little is published with regards to various arthroscopic shoulder     surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various     arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive     water retention from the arthroscopic pump could causes excessive tissue pressure and     swelling resulting in post operative pain. Unfortunately we could not find any literature in     the English language regarding varying pressure pump settings on post operative pain control.     For that reason we would like to assess how variable pump pressure effect tissue pressure     over pre set time points, and how this may relate to post operative pain control.   "
29698|NCT02896946|"     The detection of small liver metastases represents a major challenge during the staging     process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT     represents the established imaging modality for selecting patients with pancreatic     adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients     undergoing a surgical procedure are finally found to have an unresectable disease because of     arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had     not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a     better contrast resolution for soft tissue and liver imaging, and thus leads to a better     detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in     patients with potentially resectable PA may improve the selection process of candidates for     curative pancreatic resection by increasing the detection of LM undiagnosed by traditional     preoperative work-up   "
29699|NCT02896933|"     35 patients with multiple sclerosis have been enrolled in a previous study to record and     analyze gait parameters.      This study aims to enroll gender and and matched healthy subjects for a control group, to     compare patients' gait parameters with healthy subjects'.   "
29700|NCT02896920|"     This study assesses Humira's® real-life effectiveness in the management of dermatological     manifestations of moderate to severe Hidradenitis Suppurativa (HS).   "
29701|NCT02896907|"     This pilot clinical trial studies the side effects of ascorbic acid and combination     chemotherapy in treating patients with pancreatic cancer that has spread to other places in     the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary     supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens.     Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and     combination chemotherapy may work better in treating patients with pancreatic cancer.   "
29702|NCT02896894|"     This is a mixed methods study that evaluates the effectiveness of the Big White Wall (BWW)     online community and its implementation in 3 hospital/health system sites across Ontario. The     6 month study includes 1000 participants that are randomized to an immediate treatment group     or a delayed treatment group. The primary outcome includes a change in total and subscale     scores on the Recovery Assessment Scale. Qualitative interviews with various stakeholders     will explore issues relating to successful implementation.   "
29703|NCT02896881|"     In previous studies exploring specific sequences of MRI (susceptibility weighted imaging     (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility     of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging     (static or dynamic).      This prospective study aims to compare multisequence MRI to brain arteriography imaging in     patients undergoing brain arteriovenous malformations embolization.   "
29704|NCT02896868|"     The main purpose of this study is to investigate the safety and tolerability of the study     drug known as LY3041658 in participants with certain types of skin diseases. The study will     measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127     days for each participant, not including screening. This study is for research purposes only,     and is not intended to treat any medical condition.   "
29705|NCT02896855|"     This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in     China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared     with placebo + trastuzumab + docetaxel in participants with previously untreated     HER2-positive MBC.   "
29706|NCT02896842|"     Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line     therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic     responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose     is not yet determined and randomized studies addressing this question are on-going. First     results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for     patients treated with imatinib high dose. Recent studies revealed that initial Imatinib     plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a     dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses     (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).      Results from the study of Larson et al. indicate that around 40% of the patients had a trough     plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular     response rate at 12 months for the patients with the lower plasmatic through level is 25.4%     compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.      Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic     level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will     be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1)     versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000 ng/ml)     will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic     level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and     every three months in cohort 3. The first endpoint of the study will be the rate of major     molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR     rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12     months.   "
29707|NCT02896829|"     It's an observational study based on 98 patients included in the STIM trial to extend the     monitoring of patients and to have molecular and clinical data, with long follow up. Are     there late relapses? What has become patients who relapsed during STIM trial and restarted     TKI (inhibitor tyrosine kinase) treatment?   "
29708|NCT02896816|"     Study Purpose:      Parkinson's disease leads to severally impaired motor control. The purpose of this study is     to better understand and analyze the characteristics of arm muscle activity while doing some     reaching tasks and of leg muscles while walking. This will allow the investigators to improve     understanding of the mechanisms underlying the motor impairments in Parkinson's disease.   "
29878|NCT02894593|"     The purpose of this study is to evaluate the antiplaque effects of an alcohol-free     essential-oil containing mouthrinse - Listerine Zero (LZ) and an alcohol-based essential oils     (EO+) mouthwash compared to a positive control of 0.20% chlorhexidine (CHX) mouthwash, and a     negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3     days.   "
29709|NCT02896803|"     Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for     infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or     hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil     bolus and oxaliplatin). The primary endpoint is to assess the objective response rate     according to RECIST criteria (version 1.1) and the secondary endpoints are time until     clinical or radiological progression, overall survival, toxicity profile.   "
29710|NCT02896790|"     The use of oral targeted therapies draws new medical management but also new practices for     the patients (compliance), their family and the healthcare professionals [1,2]. These     therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the     patient to learn to manage. This situation underlines the importance of a therapeutic     education to accompany this learning [3]. Nevertheless, in France, the therapeutic     educational programs, built according to the standards of the therapeutic education (TE),     are still very rare in cancer research [4]. In May 2012, a therapeutic educational program     for these patients has been developed in the oncology department of the Teaching Hospital of     Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer     patients treated by oral targeted therapies, becomes here an object of research: MODAP     (action-research).   "
29711|NCT02896777|"     The culturing human embryo in vitro is a process of myriad contributing elements. From these     factors is the pH of embryo culture media, which is crucial for embryo development. The     investigators plan to examine three different pH values of the culture media on the live     birth rate of in vitro cultured human embryos.   "
29712|NCT02896764|"     Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays     are divergent, forming a cone.      As a result, this technique is less irradiating that the scanner. The purpose of this     exploratory study is to compare the performance of the scanner and the cone beam in the     detection of anatomical structures of the ear.   "
29713|NCT02896751|"     This is a small pilot study to look at the feasibility of creating a customized sleep mask     for use with Continuous Positive Airway Pressure (CPAP) or other similar treatments for sleep     apnea. The participant will have three dimensional (3D) pictures of the face taken by special     cameras. The pictures will be sent to a 3D printer and a mask will be created based on the     participant's face contours. The participant will use the mask for about 6 months. The study     will measure the amount it is used during sleep and if there is an increase in reported     comfort.   "
29714|NCT02896738|"     This pilot study aims to assess the interest to add an auditory pathway morphological     analysis during the MRI exploration of visual pathway in visually impaired children.   "
29715|NCT02896725|"     Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,     lifestyles and activity, especially in older patients. Compression bandaging is the main     treatment but there are few added treatments for patients with slow healing VLU. About 50% of     patients with VLU may be slow healing. Research suggests using keratin dressings as well as     using compression may help healing in patients with show healing VLU, but the current     evidence is not enough to change clinical practice. The investigators will conduct a     randomised controlled trial to test whether using keratin dressings is better than usual care     for slow healing VLU.   "
29716|NCT02896712|"     First, the investigators will determine whether Acceptance and Commitment Therapy in     combination with Contingency Management increases initial treatment response rates.      Second, for patients who do not respond to initial treatment, the investigators will examine     whether dopamine-targeted pharmacotherapy is an effective augmentation strategy.      Third, for patients who respond to initial treatment, the investigators will assess the     relative benefit of continued treatment with Acceptance and Commitment Therapy in combination     with Contingency Management, as compared to Drug Counseling in combination with Contingency     Management, to prevent relapse.   "
29717|NCT02896699|"     This study will evaluate the feasibility of a network intervention to train individuals to     disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in     their social networks.   "
29718|NCT02896686|"     The aim of the present study is to determine the efficacy of the placement of an onlay mesh     to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal     resection for cancer   "
29719|NCT02896673|"     Acute respiratory distress syndrome remains a serious condition, with a mortality rate of     between 30 and 50%. The use of mechanical ventilation with small tidal volumes, and by     limiting the plateau pressure in the respiratory tract below 30 cm H2O has been shown to     reduce mortality by approximately 10%, probably by reducing pulmonary hyperinflation and     pulmonary lesions induced by mechanical ventilation. It is therefore now established that the     respirator settings influence patient prognosis. However, around 30% of patients with ARDS     ventilated with these settings supposedly protective continue to present signs of pulmonary     hyperinflation on tomodensitometry, suggesting an additional reduction in the tidal volume     could be required in certain patients. Electrical impedance tomography (EIT) is a new imaging     technique that gathers functional pulmonary information at bedside.      This technique also allows a regional analysis, allowing the complexity of the spatial     distribution of ARDS pulmonary lesions to be understood. The hypothesis is that EIT is a     reliable method to detect at-risk situations of lesions induced by mechanical ventilation     among patients with ARDS.   "
29720|NCT02896660|"     HITLAB will conduct a crossover study wherein participants will be asked to wear an     actigraphy device continuously for 12 weeks. The first four weeks of the study participants     will continue their previously scheduled treatment regimen, prior to receiving the Probuphine     implant. Following four weeks of activity and sleep baseline monitoring using the actigraphy     device, the participant will receive the Probuphine implant as part of their regularly     scheduled treatment plan. Observation of the participant's activity levels will continue for     eight weeks following implantation of Probuphine. Actigraphy measurements will include total     time asleep, total time awake, sleep efficiency, and time mobile.   "
29721|NCT02896647|"     This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation     (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of     this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of     neuraxis inflammatory diseases.   "
29722|NCT02896634|"     Dried Blood Spot or DBS is a collection of blood capillary drops spotted and dried on to a     filter paper used for different bioanalysis. In comparison to conventional blood testing, DBS     offers practical, analytical, clinical and financial advantages. This less invasive sampling     is already used in infectious diseases screening and is useful for persons with poor venous     (babies, drug users or elderly). Mass-spectrometry-based analyses allow protein     quantification on very low amount of blood sample. In the project we combine the two     approaches to measure on DBS blood proteins with clinical relevance -including many FDA     approves biomarkers). The detection of the relevant clinical analytes will be validated on     available patient samples in accordance with the clinical norm ISO15189 and the requirement     for CE IVD marking. This will allow commercial developments (kits, protocols...) realized     with the industrial partner Spot-to-lab   "
29723|NCT02896621|"     The investigators investigated diastolic function among patients with obstructive sleep apnea     (OSA) and hypertension stage I. In this randomized controlled trial, participants were     randomly allocated to one of two groups: chlorthalidone associated with amiloride or     amlodipine. Randomization was carried out prior to the start of the trial by an     epidemiologist out of clinic and the randomization list was stratified by gender and severity     of OSA. The research team and participants were blinded to the randomization list and     allocation concealment was implemented. This trial aimed to detect changes in the     echocardiography parameters with the drug treatment (higher in the intervention than in the     placebo group). The investigators also assess change in daytime sleepiness among participants     who already have been diagnosed with OSA.   "
29724|NCT02896608|"     This study addresses the changes in the axonal excitability parameters. It will compare these     changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation     and in control patients, with and without epilepsy.   "
29741|NCT02896387|"     Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic     abnormalities, primarily affects the skin and cornea. The most common forms are called     Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and     Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic     treatment, no cure is available. To understand the molecular defects associated with this     disease and to identify therapeutic tools, a research team modelized the disease by     reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced     iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and     demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in     patients.      P63 gene belongs to the family of p53 gene. The functions of the two proteins are very     similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in     patients and thus alleviate skin defect healing and limbic regeneration.   "
29725|NCT02896595|"     In recent years it has been shown that catheter ablation of symptomatic atrial fibrillation     (PAF) is superior to antiarrhythmic drug therapy with regards to effectiveness and clinical     outcomes. Atrial fibrillation is the most common cardiac arrhythmia, with high rates of     concomitant heart failure, stroke and mortality. During an ablation procedure, a patient can     be managed with intravenous sedation or General Anesthesia (GA). Within this setting, General     anesthesia is associated with improved procedure time and cure rate compared to sedation.      Airway management during GA can be achieved through a laryngeal mask airway (LMA) or an     endotracheal tube (ETT). The use of LMA compared to ETT has been shown in different surgical     populations to decrease procedure and recovery time, improve hemodynamic stability and reduce     anesthetic requirements. It has also shown to decrease airway complications, and     postoperative nausea/vomiting which are important factors that affect overall patient     satisfaction.      Although general anesthesia in electrophysiology procedures is associated with a higher cure     rate, there have been reports of increased airway trauma.Additionally, it is believed that     volatile anesthetics may be associated with increased ventricular action potential duration     as well as prolonged QT interval. The increased usage of opioids during general anesthesia is     also thought to interfere with electrophysiology studies by affecting vagal tone.      At Virginia Commonwelath University (VCU) Health system, Anesthesiologists have been     successfully using LMA (General Anesthesia) for ablation in PAF in eligible patients for over     five years. The investigators plan to perform a retrospective review of all patients who     underwent catheter ablation of PAF at Virginia Commonwealth University Health System from     January 2014 - December 2015. The primary endpoint evaluated will be procedure time. Other     data collected will include demographics, cardiac history, type of anesthesia, amount of     intra-procedure opioids, time to discharge from post anesthesia care unit (PACU), total     length of hospital stay, intra-procedure hemodynamics, intra-procedure     ionotrope/chronotrope/pressor requirements. and atrial fibrillation recurrence at a 3 month     follow-up.   "
29726|NCT02896582|"     This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront     obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone     (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular     Residual Disease (MRD) driven maintenance   "
29727|NCT02896569|"     The purpose of this study is to compare the tolerability of the application of a combination     of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and     cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional     radiofrequency treatment using the Venus Viva versus standard of care.   "
29728|NCT02896556|"     The purpose of this study is to evaluate the esthetic performance of resin infiltration     technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth   "
29729|NCT02896543|"     This study evaluates the relationship of change of dendritic cells fractalkine and P-selectin     in patients with acute myocardial infarction.   "
29730|NCT02896530|"     Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly     Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal     complications. In over 60% of cases, these vascular complications of deep venous thrombosis     (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a     risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely     related to disease activity.   "
29731|NCT02896517|"     Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most     cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened for     the most affected by this disease and aggravating factors population, associated     comorbidities.      The rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities.        -  Acute renal failure and hyperkalemia are the major complications that worsen the          prognosis.        -  In most cases, acute renal failure is reversible. Acute renal failure caused by renal          vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct          cytotoxic action of myoglobin.      If the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the     tissue damage is greatly aggravated during muscle reperfusion, creating ischemia-reperfusion.     Reperfusion will not only cause the release into the bloodstream of the cell contents     myocytes but also an increase in necrotic areas. Indeed, the massive arrival of oxygen at the     myocyte will cause significant production of free radicals, increasing their toxic effects.      Predictive factors of acute renal failure is creatinine and urea. The urine alkalinisation by     bicarbonates is questionable oral alkalizing seems to be an alternative when possible (oral     alkaline solution) but not used to this day.      The track N-acetyl cysteine as an antioxidant that can possibly have an effect on release of     the free radicals during reperfusion by decreasing their toxicity is still not considered     clinically.   "
29780|NCT02895880|"     The purpose of this study is to collect initial data on what survivors of childhood,     adolescent, and young adult cancer think of how information about statins is communicated.     Statins are medications that lower cholesterol. The results of this study will be used to     improve the communication about statins. This is to aid patients and their providers in     making health care decisions together, also known as shared decision making.   "
29732|NCT02896504|"     Some cancer patients report experiencing mild problems with thinking during or following     chemotherapy. Symptoms include problems concentrating, slow thinking, some gaps in memory and     difficulty performing complex or multi-tasks. These symptoms often soon disappear after     treatment. However for some patients, they may persist for years and this can have a     significant effect on their quality of life. The reasons for these symptoms are not well     understood.      This study proposes to examine the effects of chemotherapy on the brain and how the changes     in the brain affect one's ability to move one's arms and fingers. By better understanding the     negative consequences of chemotherapy on the brain and nervous system, the hope is to help     pharmaceutical companies develop safer cancer treatment drugs.   "
29733|NCT02896491|"     To investigate possible effects of radio frequency electromagnetic fields on EEG activity     during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG     potentials, auditory evoked potentials) and cognitive performance measures in test of     selective attention, divided attention and working memory in healthy elderly males (60 - 80     years).   "
29742|NCT02896374|"     Case-control comparison of clinical population, interventional and single-center research.   "
29743|NCT02896361|"     This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing     stimulation paradigms in patients with chronic pain.   "
29744|NCT02896348|"     The goal of this study is to explore if the SynPhNe system can be used without difficulties     in the home setting for upper extremity rehabilitation therapy for people who suffered a     stroke.   "
29745|NCT02896335|"     This research study is studying palbociclib as a possible treatment for recurrent brain     metastases.      - Pfizer, a pharmaceutical company, is supporting this research study by providing the study     drug as well as funding for research activities   "
29734|NCT02896478|"     The path of a patient depends largely on his health care network, that is to say of the     interrelationships between health professionals who will be involved throughout his career.     At the hospital, the transition points in the care process is a vulnerable time for the     patient regarding the continuity of his medication. These transition points are the intake,     the transfer and the outlet. In town, our health system must be able to build on the     inter-city hospital, warranty essential guarantee of the continuity of care. However, there     is often a breakdown in this relationship with more or less serious consequences ranging from     simple dissatisfaction of the patient, to the realization of duplicate examinations or the     use unjustified emergency and re-hospitalization. Medication errors can occur, resulting from     incomplete information or poorly communicated in this city hospital interface.      The city hospital dysfunctions are mainly organizational, hospital being rather specialized     therapeutic approach centered on pathology and medicine city instead focuses on a patient's     overall approach.      The involvement of the pharmacist in the hospital, as the city is an interesting axis to     develop. In town, the pharmaceutical nomadism, including in major cities remains low,     patients generally have a dedicated pharmacies for the treatment of their serious or chronic     pathologies. The development of the pharmaceutical dossier today allows the pharmacies to     access the history and the entire therapy of patients prescribed to town by different     specialists and general practitioners, on the last 4 months. Its recent availability within     our hospital Group allows us to consider its use to fully optimize the patient's drug     monitoring.   "
29735|NCT02896465|"     Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute     diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients     hospitalized with acute diarrhoea.   "
29736|NCT02896452|"     The investigators have documented a genetic predisposition for some astronauts to develop     ophthalmologic issues (e.g., choroidal folds, cotton wool spots, optic disc edema). Women     with polycystic ovary syndrome (PCOS) have several characteristics similar to those described     in astronauts, including: higher homocysteine concentrations, increased incidence of     intracranial hypertension, increased retinal nerve fiber layer thickness, increased incidence     of white matter hyperintensities on MRI, increased androgen concentrations (or androgen     responses to space flight), and indices of altered carbohydrate metabolism. Women with PCOS     have not been evaluated in detail regarding the occurrence of other anomalies observed in     astronauts including choroidal folds, optic disc edema and cotton wool spots as well as     changes in cycloplegic refraction, and optic nerve sheath diameter. While researchers have     evaluated one-carbon metabolism pathway polymorphisms re: PCOS, and initial studies show an     association with certain one-carbon polymorphisms, none have looked at the complete set of     SNPs proposed here. This study will evaluate women with PCOS and/or idiopathic intracranial     hypertension (IIH) to assess one-carbon biochemistry and genetics and their possible     correlation with ophthalmologic findings. The investigators aim to clarify the relationship     of one carbon metabolism and ophthalmic findings in astronauts and patients with PCOS and/or     IIH.   "
29737|NCT02896439|"     Pelvic fractures in which integrate the acetabulum fractures represent a risk of traumatic     injury to the sciatic nerve trunk by stretching or section (1): Judet and Letournel reported     a complication rate of around 6% (1). Fractures of the acetabulum strictly speaking are also     providers of neurological complications with rates, significant, have recently been precisely     detailed by a cohort study published by Lehmann et al. (2): In a series of 2073 patients, the     authors reported an overall complication rate of neurological related to the initial trauma     of the order of 4%. In this series, 1395 patients were operated with a rate of iatrogenic     neurological complications of 2 to 3%. Regarding the first routes (and therefore the types of     fractures), the Kocher-Langenbeck path is the path that leads to the greatest number of     neurological complications: 3 to 4% in this series (2). However, this cohort study does not     specify what truncal achievement it is. Obviously violations posterior acetabular are     preferentially providers of sciatic injury while violations prior acetabular are more     providers of obturator or femoral lesions. But this is not always the case. Moreover, this     study does not specify the type or severity of neurological involvement.   "
29738|NCT02896426|"     The main objectives of this study are to evaluate the feasibility, acceptability, and effects     of a CPS parent group on outcomes for a sample of parents of children ages 3 to 5 compared to     outcomes after attending a parenting group that promotes behavioral (operant) parenting. We     hypothesize that guardians in the CPS group will report a better understanding of how     neurocognitive skills relate to children's behaviors, greater improvements in child     functioning and behavior, and greater reductions in parents' stress than those in the     comparison group.   "
29739|NCT02896413|"     Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer     patients. The natural killer (NK) cell is a critical part of anti-tumor immunity.     Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study     investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes in     patients undergoing uterine cancer resection.   "
29781|NCT02895867|"     This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate     the effect of dairy products with full or low fat on glycemic control and cardio-metabolic     risk factors in comparison to a regular diet.   "
29740|NCT02896400|"     The investigators propose an innovative full-factorial design in a cohort of 1056 adult     smokers in an urban emergency department (ED), to test the efficacy of four key intervention     components: motivational interviewing, medication, quitline referral, and texting. At the     trial's completion, a mixed-methods approach will be used to identify the components that     were efficacious within the proposed cost constraint, along with feasibility and     acceptability to providers and subjects. The investigators will then assemble an intervention     that maximizes efficacy, given a cost-effectiveness constraint and findings from a     qualitative analysis.   "
29746|NCT02896322|"     Accelerated partial breast irradiation with CyberKnife (CK-APBI) is a promising innovative     approach for early breast cancer after conservative surgery, for addressing the need of a     radiotherapy target only to the surgical cavity in selected patients, exceeding the limits of     other PBI/APBI.   "
29749|NCT02896283|"     The aim of this randomized split-mouth design clinical trial is to clinically evaluate the     effectiveness of diode laser in the healing of donor site of palate in free gingival graft.   "
29750|NCT02896270|"     The trial investigates the use of VPA (Valproic Acid) for the treatment of adult patients     with biopsy proven idiopathic focal segmentel glomerulosclerosis (FSGS) or minimal change     disease (MCD).      VPA used as an add-on to steroids might induce clinical remission in a first category of     patients and potentially reduce the dose of maintenance immunosuppression required to     maintain remission thereafter.      In a second category of patients VPA might allow the reduction or even cessation of     immunosuppression while clinical remission is maintained.   "
29751|NCT02896257|"     This Quality Enhancement Research Initiative (QuERI) is designed to determine efficacy and     acceptance of an intervention method to provide primary care providers with patient-tailored     electronic consults and corresponding unsigned orders for de-implementation of inhaled     corticosteroids (ICS) for patients with COPD when ICS are not indicated by guidelines.   "
29752|NCT02896244|"     During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota     (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the     occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile     infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and     severity of CDI are considered as worldwide public health threats.      Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device     in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to     carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of     antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and     treated with predefined antibiotic classes known to increase the risk of CDI. The incidence     of CDI in this population is unknown, yet, incidence is an important determinant for the     required sample size.      Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50     years of age treated with predefined antibiotic classes.      In addition, to optimise the target population of the DAV132 RCT, the effect of the     predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore,     biomarkers predictive of CDI occurrence might help identify patients at high risk for the     disease, which could further optimise the RCT. No validated biomarkers have been described in     the literature yet. Assessment of potential biomarkers is another aim of the present study.   "
29753|NCT02896231|"     This phase I, first-in-human dose-escalation study was conducted to determine the maximum     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),     pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.   "
29782|NCT02895854|"     The aim of this trial is to find out if there are any differences in the profiles of acute     and late adverse effects among men with low and intermediate risk prostate cancer treated     either with low dose-rate brachytherapy or hypofractionated external radiotherapy     (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each     treatment will be analysed.   "
29879|NCT02894580|"     The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden     cardiac death (SCD) is well demonstrated but pivotal studies have been published more than 10     years ago and implantation's conditions tend to change.   "
29754|NCT02896218|"     Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment     of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus     (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin     concentration in clinical practice, especially in the critically ill patients. So far, few     studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage     is administered and adjusted individually using PPK and Bayesian methods based on observed     concentrations. The objective of this study is to investigate the effectiveness, safety and     economics of the vancomycin individualized dosing service provided by pharmacists.   "
29755|NCT02896205|"     Systemic sclerosis is a multisystem disease and can involve the lungs in the form of ILD.     Lung involvement is the most common cause of death in these patients. The present study is     performed to study the efficacy of oral mycophenolate mofetil in treating early and mild ILD     in patients of SSc. The efficacy and side effects of mycophenolate mofetil will be compared     with that of oral placebo.   "
29756|NCT02896192|"     The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight and     other factors in patients with pro-opiomelanocortin (POMC) deficiency obesity due to rare     bi-allelic loss-of function POMC or PCSK1 genetic mutations.   "
29757|NCT02896179|"     Multiple Sclerosis (MS), the most common non-traumatic cause of neurologic disability in     young adults, affects mobility and ambulation in the majority of patients. Nearly 50% of     persons with MS will require an assistive device to ambulate within 10 years of diagnosis. A     subgroup of MS is Primary Progressive MS, which manifests with gait disturbances over 80% of     patients in the long term. In addition to altered gait, nearly 70% of patients will     experience cognitive deficits during the course of the disease. Therefore, actions that     facilitate patient involvement in finding solutions for personalized management of disease     and disability are needed.      Although immunomodulatory drugs offer some benefit in other types of Multiple Sclerosis,     there is currently no effective treatment for Primary Progressive MS. A fundamental goal in     the management of persons with MS is to maximize their ability to ambulate and perform safe     and effective transfers in everyday life.      In the last decade, research has increasingly centered on the effects of robot devices in the     rehabilitation of patients with neurological diseases. This has led to the development of new     robot-assisted gait devices engendered by virtual-reality systems, and several studies have     demonstrated the positive effects that these devices have on gait endurance and quality of     life in patients with neurological diseases and disability.      The aim of this project is to develop and study the effects of a novel, cognitively intensive     virtual-reality -based rehabilitation software application that simulates a real-world     environment where a person can walk. The virtual-reality application is an upgrade version     synchronized to a robotic device, the GEO System. The second aim is to compare the cognitive     and motor effects of robot-assisted gait training with this application against training with     robot-assisted gait training without virtual reality.      The experimental group will receive robot-assisted gait training with the virtual-reality     application and the control group will receive robot-assisted gait training All subjects will     undergo training for 6 weeks (2 sessions/week) for a total of 12 sessions. Assessments before     training, after training, and at follow-up will be performed using clinical and instrumental     tests to compare the effects of training.      Successful completion of the study may help patients to alleviate the impact of disability,     increase their independence in activities of daily life, and improve their quality of life.     Through new rehabilitative strategies that combine cognitive and motor training involving     higher brain functions and motivation, patients will be stimulated to walk in a reality-based     environment.   "
29758|NCT02896166|"     Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung     cancer accounts for 85%. Only part of patients could be treated with radical surgery, and     some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse     surgery. For those patients, microwave ablation (MWA) could be an alternative treatment.     Several small sample retrospective studies verified that MWA could be an efficacy and safe     treatment.   "
33452|NCT02847910|"     The purpose of this study is to explore the clinical effect of disposable tissue suction tube     set for induced abortion and make comparison with traditional metal instruments．   "
29759|NCT02896153|"     In France, consumption of hypnotic drugs is high. In this context, and given the planned     regulatory modifications, it seems essential to make an inventory of the consumption of drugs     taken for a hypnotic purpose. This study aims to identify the substances (medical or not)     used for a hypnotic purpose in the adult population going to a pharmacy.   "
29760|NCT02896140|"     The aim of this study is to determine the relationship between the percentage of calories     from dairy intake and long-term glycemic control and weight maintenance in patients with type     2 diabetes who participate in an intensive lifestyle intervention program.      The investigators hypothesize that overweight and obese patients with type 2 diabetes who     consume higher percentage of calories from dairy products during intensive lifestyle     intervention programs have better glycemic control and maintenance of weight loss as compared     to those who consume lower percentage of calories from dairy products.   "
29761|NCT02896127|"     To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to     placebo in patients with ankylosing spondylitis at Week 16 and long term efficacy and safety     up to Week 52.   "
29762|NCT02896114|"     The study aims to evaluate the current methods of surgical treatment for Congenital     Pseudarthrosis of tibia(CPT) in children and their results respectively.   "
29763|NCT02896101|"     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study     to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark     Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant     Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis     (AD).   "
29764|NCT02896088|"     Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and     its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary     dentition could slow the specific development of carious lesions in early childhood. In     addition, this non-invasive approach could delay the conventional food and thus save     financial costs for more complex treatments. Finally, the installation of AS could afford, as     demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the     caries process.   "
29765|NCT02896075|"     The purpose of this study is first to investigate the effect of a controlled intervention     with a comedy video on pain tolerance in a social setting while quantitatively measuring     laughter in a young healthy population experiencing delayed onset muscle soreness. The comedy     intervention will be compared to a control of watching a documentary. The second aim is to     examine to what extent various methods of eliciting pain would cause physiological responses     that confound the interpretation of a pain stimulus.   "
29766|NCT02896062|"     In the present study, a 4-week sleep coaching program is developed and evaluated in members     of the German armed Forces. The aim of the program is to provide an efficient tool to prevent     sleep disorders, and to improve mild sleep disorders, with a special focus on insomnia.   "
29767|NCT02896049|"     Based on the basic data of all patients foreseen for a local hyperthermia in the     participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the     complication rate (injury to the patients) will be recorded.   "
29805|NCT02895542|"     This study to find out more about how patients take their anticancer medications and     challenges related to taking cancer medications.   "
29768|NCT02896036|"     Purpose: The primary objective is to compare the time required for adequate intraperitoneal     insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the     number of attempts needed before successful entry is achieved. The secondary objectives will     evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal     insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental     injury between the two techniques.      Study design: prospective randomized control trial      Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery     for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress     needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of     intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation,     and will require less number of attempts to achieve successful entry.   "
29769|NCT02896023|"     Patients will be subjected to:      A. Clinical evaluation including history and examination      B. Ultrasonographic evaluation of Ovarian Morphometry:        -  Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days          1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only          one examiner to avoid inter-observer variations.        -  Ovarian images will be procured in the sagittal and coronal planes and the frozen image          reflecting the largest ovarian dimensions will be utilized for the measurement of          ovarian length, width, and height (cm) as per standard clinical practice. Mean values of          both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume          formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3)          × 0 .523}        -  Antral follicle count will be determined for each patient      C. Laboratory Evaluation:      Blood samples will be collected in the early follicular phase. Samples will be immediately     centrifuged and serum saved at -20 degrees for measurement of:        -  Anti Mullerian Hormone (AMH)        -  Follicle Stimulating Hormone (FSH)        -  Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)   "
29770|NCT02896010|"     Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed     to promote adherence to physical activity guidelines for people with prediabetes.   "
29771|NCT02895997|"     The purpose of the study is to determine if temporarily relocating clinicians who deliver     remote care using the eICU telehealth system to Sydney, Australia will lead to greater job     satisfaction, reduced physiologic stress, and improve performance. Four nurses and six     physicians will be sent to a site in Sydney Australia on a rotating basis to determine     whether providing care during the Australian daytime is more efficient and precise than     providing care during the night in the United States.   "
29827|NCT02895256|"     Cluster headache is a syndrome characterized by disabling headache and accompanying autonomic     symptoms. Despite cluster headache is called suicide headache, its natural history has not     been well investigated. We aimed to investigate its disease course, overall prognosis, and     treatment pattern in our retrospective cohort.   "
29772|NCT02895984|"     Alcohol use is almost ubiquitous on college campuses and first-year students are at     particularly high risk of alcohol-related harm when they first make the transition to     college. Peers are important agents in socializing both healthy and unhealthy behaviors, but     despite the clear role of peer behavior in the maintenance of college problem drinking, there     have been no efforts to measure the effect of individual change on the reduction of     alcohol-related risks in the broader student body. That is, despite the importance of social     connections for inducing and maintaining alcohol use in youth, intervention approaches have     not measured nor capitalized on the potential of social influences for changing this problem     behavior. It is essential that we understand the indirect effects of individual interventions     and the impact such interventions have on the social structure and social connections. The     best way to evaluate such effects is to use a research design that experimentally manipulates     drinking using the best available intervention and measures its effects on the social network     and its members.      The purpose of this research is to investigate whether using an established individual Brief     Motivational Intervention (BMI) administered to a small number of influential network members     embedded in a social network significantly reduces heavy drinking and alcohol consequences     among close peers who do not receive any intervention (the investigators call this the     indirect intervention effect). In addition, the investigators will investigate putative     social influence mechanisms of this transmitted effect, investigate how specific types of     network connections and relationships moderate the indirect intervention effect, and     investigate the effects of the intervention on network position and structure. First-year     students at Brown (N = 1,280) will be enrolled and assessed early in their fall 2016 academic     semester. Using baseline data, dormitories (N = 10) will be matched on size and randomly     assigned to one of two conditions: BMI or natural history control (NHC). Heavy drinkers in     each dormitory who are in the top quartile of betweenness centrality, a social network     construct that reflects high connectivity and potential influence, will either receive BMI or     serve as controls, according to their dormitory's intervention assignment. All participants     will be assessed again 5 and 12 months after baseline to measure changes in behavior and in     peer ties in the entire network of first-year students. The long-term objective of this     research is to understand how peer influences function in social networks in order to     leverage those mechanisms to reduce problematic alcohol use in heavy drinking populations.   "
29773|NCT02895971|"     The aim of this study estimate VTE incidence. Investigators prospectively record all cases of     symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs     diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.   "
29775|NCT02895945|"     The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with     congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective     surgical, dental, or other invasive procedures.   "
29776|NCT02895932|"     The purpose of this study is to determine if changes in brain serotonin affects the     accumulation of amyloid in the brain. The investigators will use brain imaging methods to     measure the amount of serotonin and amyloid in the brain of individuals with Parkinson's     Disease (PD) and otherwise healthy older people. PD participants will undergo repeat brain     imaging to assess amyloid accumulation two years after their first brain imaging session. All     participants will undergo examinations to assess their motor function, and asked questions to     assess their mood and thinking.   "
29777|NCT02895919|"     This study seeks to determine non inferiority of direct inoculation of ascitic fluid in lab     as compared to current culture media standard, bedside inoculation with blood culture     bottles.   "
29778|NCT02895906|"     This is a 5-week, multi-center, open-label, dose optimization trial in subjects aged 12-17     years with 22q11DS who have a diagnosis of anxiety disorder, and/or ADHD, and/or ASD.     Approximately 12 subjects will be initiated, dose optimized, and maintained on NFC-1 over a     period of 5 weeks.   "
29779|NCT02895893|"     The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency     management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis     (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, the     app).   "
29806|NCT02895529|"     The purpose of this study is to investigate the hypothesis that the efficacy of intravenous     (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous     caspofungin as empiric therapy for suspected fungal infection participants with fever and     neutropenia.   "
29783|NCT02895841|"     The purpose of this study is to learn more about the ways in which mobile technology can be     integrated into inpatient care to help better track pain levels using mobile technology of     patients with sickle cell disease, oncology patients, and bone marrow transplant patients.     The study will assess whether or not daily mobile monitoring with wearable accelerometers     (devices that detect movement as well as heart-rate) to monitor and manage medical treatments     can have a lasting positive impact on outcomes in patients with chronic diseases. The     investigator hopes to learn more about the ways in which mobile technology can be integrated     into inpatient care. Specifically, the investigator is looking to help patients better track     their pain, use wearable technology to track physiological measures (for example, heart rate,     sleep quantity and quality), and integrate these data points into the medical care of     patients by providing the information to providers. This study will first gather information     regarding the feasibility and acceptability of the use of technology on the inpatient unit.     This will help the study team to refine the technology of the mobile app and logistics of     integration. Following this, the investigator will complete a second phase of the study,     during which select patients will pilot the intervention. This will be followed by the third     and final phase, during which patients will be randomly assigned to the active intervention     or standard of care. This phase approach will enable the study team to refine the     intervention, relying on the feedback from patients and providers, and subsequently test its     utility compared to standard of care through random assignment.   "
29784|NCT02895828|"     This study will compare the effects of 2 exercise programs including core stabilization     exercise and general trunk strengthening exercise programs on trunk muscle activity, physical     dysfunction, quality of life and lumbar motion in low back pain patient with clinical lumbar     instability.   "
29785|NCT02895802|"     Purpose: To assess the feasibility of using videos depicting people with DS to teach other     adults with DS to perform healthy behaviors.      Hypothesis: Videos of adults with DS performing healthy behaviors is a more effective way to     promote healthy behaviors by adults with DS than other methods tested.      This project will study whether videos showing a person with DS washing his hands correctly     can improve hand washing by other adults with DS.   "
29786|NCT02895789|"     This proposal will focus on (1) estimating oxidative capacity of specific muscle groups     during exercise using near infrared spectroscopy and (2) describing body composition to     better understand exercise capacity and mitochondrial function in ambulatory spinal muscular     atrophy (SMA) patients and disease controls. It is a 6-month observational study including 14     ambulatory SMA patients, 14 ambulatory patients with mitochondrial myopathy, and 14 healthy     controls.   "
29828|NCT02895243|"     This pilot study will be a clinical trial to test the feasibility and effectiveness of a     kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease     (ESRD) who are within 3-6 months of transplantation.   "
29787|NCT02895776|"     Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data     tend to show that final neurologic outcome is superior if the thrombectomy procedure was     performed under conscious sedation.      The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures     every year.      We report a rate of 5% of these procedures requiring general anesthesia despite conscious     sedation being the standard of care. This study aims to identify clinical factors associated     with a risk of conversion of a conscious sedation to a general anesthesia.   "
29788|NCT02895763|"     A Quality work was conducted to enable the future construction of a Quality of Life     Questionnaire Related to Health (HRQoL) in patients with slowly progressive neuromuscular     disease (NMD) as myopathies and muscular dystrophies. The discussion group training is an     effective method to perform a thorough investigation of aspects of HRQoL potentially altered     by NMD. Patients were recruited in France by 4 reference centers MNMs. All verbal     interactions between participants focus groups were recorded. A qualitative analysis of the     transcript was performed. The transcript provided 2424 CIF categories. The results helped to     identify and quantify aspects of life that are altered by NMDs between patients. A pool of 64     items and a validated questionnaire (the WHOQOLBREF) were thern passed by 159 patients     enrolled in eight reference centers MNMs. The investigators constructed a questionnaire     called QoLNMD which is composed of two general items and 24 items classified into three     areas: (1) \ Impact bodily symptoms, (2) \ Self-perception and (3) \ Activity     participation. Each area has good psychometric properties (Cronbach's alpha> 0.77,     test-retest ICC> 0.81, H Loevinger> 0.41) and met the assumptions of IRT. the comparison with     the WHOQOL-BREF was used to assess similarities and differences with a generic questionnaire.     The next step was to validate the QoLNMD reassessing its psychometric properties in a new     patient sample and calibrate the IRT measurement system. The purpose of these new part of     study was to validate the French version of the QoL-NMD on a confirmatory sample of patients     and to calibrate its measurement system. A prospective study in 8 NMD referral centers     (France) was conducted. Both the QoL-NMD and a validated generic questionnaire (the     WHOQOLBREF) were administered to patients. 156 patients were included for the confirmatory     psychometric analysis. All three domains showed adequate psychometric properties and met IRT     assumptions. The IRT model calibration was then performed successfully on 315 patients. The     French version of the QoL-NMD showed adequate psychometric properties and can be used in     rehabilitation services. A conversion table enables easy transformation of sum scores into     IRT-calibrated measures. Minimum detectable change tables help interpreting score change.   "
29789|NCT02895750|"     There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and     there is no available data in chronic kidney disease (CKD). The planned study aims to provide     data on glucose plasma level in relation to metformin plasma level in Diabetes Type II     patients.   "
29790|NCT02895737|"     This prospective, randomized study was designed to analyse the difference of cerebral     embolization in patients undergoing transcatheter aortic valve implantation with     balloon-expandable vs. self-expandable valves by using a cerebral protection system (Claret     Sentinel™ Device).   "
29791|NCT02895724|"     The purpose of this study is to examine if pressurechamber treatment (HBOT) can reduce early     stages of breast cancer related lymphedema, and to explore the mechanisms involved in the     disease progress.   "
29792|NCT02895711|"     The purpose of this study is to quantify the radiation exposure from diagnostic testing and     surgical treatment during routine endourologic procedures for symptomatic urolithiasis.   "
29793|NCT02895698|"     The main aim of this study is to investigate the effects of dry cupping on calf muscle     trigger points in patients with plantar heel pain. A secondary aim is to examine the     correlation between several outcome measures in those patients.   "
29794|NCT02895685|"     The investigators have planned a randomized study, examining the effect of self-directed     training in groups vs. individual training on trainees' acquisitions of open surgical skills.      Eighty participants who signed up for a pre-existing simulation-based course in basic open     surgical skills will be randomized to practice either in pairs or individually during the     course. Participants open surgical skills will be tested on a simulated skin model before and     after the course. The investigators hypothesis is that dyad training will enhance     self-directed learning in open surgical skills.   "
29820|NCT02895347|"     The goal of the project is to define the optimal learning environment and protocol for dvSS®     simulation activities using medical students as robotic-naïve research participants.   "
29795|NCT02895672|"     This is a real-world, pre-post observational study from an ambulatory endocrinology practice     which will determine the effectiveness and safety of the addition of glucagon-like     peptide-1(GLP-1) agonist therapy (weekly exenatide {Bydureon} or daily liraglutide     {Victoza}), added to the regimens of T2DM patients who have already received a minimum of one     year of basal insulin therapy. Specifically, the investigators hypothesize that GLP-1 agonist     therapy added to basal insulin therapy will result in statistically significant improved     glycemic control and weight loss, with no higher risk of hypoglycemia compared to baseline.   "
29796|NCT02895659|"     Background: Currently used crystalloid solutes have a variable composition and may therefore     influence acid-base status, intra- and extracellular water content and plasma electrolyte     compositions and have a major impact on organ function and outcome. Despite continuing     evaluation no superiority of one particular type of fluid has been reached so far. To the     best of the investigators' knowledge no study in humans has ever assessed whether the type of     crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an     impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model     it was shown that the choice of crystalloid fluid may greatly influence cardiac performance      Primary Aim: In this study the investigators want to clarify whether a balanced type     acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with     better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.   "
29797|NCT02895646|"     Beta-lactam antibiotics include penicillin and cephalosporins and are among the most     prescribed antibiotics. This category of drugs is the most involved in immediate allergic     manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000     treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin,     revealed by studies in groups of different ethnical origins in the same geographical region.     There are also some families with a high frequency of allergic reactions without identified     Mendelian inheritance.      The purpose of this study is to identify predictive risk factors associated to immediate     allergic reactions against beta-lactam antibiotics with a pangenomic approach.      A secondary purpose is to identify rare predictive factors with homozygosity mapping and     exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.   "
29857|NCT02894866|"     The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in     term gestation newborn infants with hypoxic-ischemic encephalopathy..   "
29798|NCT02895633|"     The purpose is to compare and evaluate multiple functional imaging methods (perfusion,     diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular     tumors and to determine which method or which association of methods could improve non     invasive tissue characterization.      Secondary purposes are:        -  to determine a possible correlation between some parameters and the histological grade          (FNCLCC)        -  to suggest a coherent diagnostic imaging approach for osteoarticular tumors.      The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is     to identify tools for evaluation of tumor activity and therapeutic response before     modification of morpho-volumetric data.   "
29799|NCT02895620|"     Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention     of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given     once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells     (acute and chronic induced inflammations) and as a consequence causes side effects. The     investigators postulate that Xpert® test might be used to demonstrate the presence of     residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of     intravesical treatment, which could be of very significant impact in the management of this     complex situation.Urines of BCG treated patients are rich in immune system elements     (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with     urinary biomarkers. This study will allow assessing the effect of the complex inflammatory     milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer     assay.   "
29800|NCT02895607|"     Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries     in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for     CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties     anterior cruciate are still carried out predominantly in conventional hospitalization (HC)     with a median of 3 to 5.5 days of stay.      Two recent prospective studies French single-operator shows the feasibility of reconstruction     of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the     risks are comparable to those of a HC.      However, this support requires a structure and a coordinated network between different     medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor,     physiotherapist).      The objective of the study is to evaluate (i.e. EPP or feasibility) ACL reconstruction in     CA in hospitals, multi-operator.   "
29801|NCT02895594|"     Retrospective medical chart review of patients undergoing surgical repair of idiopathic     macular hole   "
29802|NCT02895581|"     Retrospective medical chart review of HIV-infected patients diagnosed with progressive     multifocal leukoencephalopathy   "
29803|NCT02895568|"     This study is to measure prevalence of established and candidate molecular markers of drug     resistant malaria at Komé, Doba, Republic of Chad.   "
29804|NCT02895555|"     The average life expectancy in Denmark is increasing resulting in an increasing part of the     population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes     constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,     especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa et     al.). LSS occurs in a combination of degenerative changes in the lower back, including     hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc.      Current treatment of LSS is varied ranging from non-operativ conservative treatment to     operation.      Operative intervention shows very good results according to physical ability and     pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),     but the most optimal treatment is still debated. Nevertheless, a decompression and, if     needed, a spinal fusion is recommented.(Ausman).      The investigators want to se whether i-FACTOR improves clinical outcomes compared to using     allograft in spinal fusion in the elderly, and thereby find an improved methods operating     this diffycult patient population.      The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR     or allograft i non-instrumentated spinal fusion surgery in patients with spinal stenosis due     to degenerative listhesis.   "
29807|NCT02895516|"     The study is a prospective, open-label, single-arm study, to evaluate the ease of use,     tolerability, efficacy and safety of the Vibrant Capsule administered in the home     environment.      One arm will be assessed: Vibrant Capsule administered twice a week.      Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a     treatment period of 6 weeks.      During the 2 weeks of baseline, patients will be asked to refrain from taking any medication     or supplement to relieve their constipation.      After 14 days the patients will return and eligibility will be re-assessed. Patients will be     instructed to complete a simple patient eDiary each day throughout the duration of the study.     After 3 weeks of treatment, the patient will attend for evaluation and to receive new     capsules. A final visit will take place at the end of the 6 week treatment period.   "
29808|NCT02895503|"     The purpose of this research study is to evaluate the effects of yoga (including breathing     exercises) on the quality of life in patients, diagnosed and undergoing standard treatments     for non-small cell lung cancer.   "
29809|NCT02895490|"     This randomized clinical trial studies communication training in promoting employment     retention among cancer patients. Communication training may improve patient-employer     communication and increase the likelihood that cancer patients will remain employed, reduce     patients' time away from work, and increase workplace accommodations that enable patients to     balance treatment and work.   "
29810|NCT02895477|"     Goal of this study is to determine the benefit of an improved feature on a new hearing aid     platform.      To investigate the improvements of this feature is compared on a new and older hearing aid     platform. The obtained results will be used for future improvement for this feature. This     feature should improve the speech understanding and speech recognition of the hearing aid     user.   "
29811|NCT02895464|"     The purpose of the study is to evaluate the feasibility of recruitment procedure,     intervention including compliance and the collaboration between in- and out patient clinics     of preoperative home-based exercise in older people before colorectal surgery.   "
29812|NCT02895451|"     The purpose of this study is to investigate the effects of an extended behavioral     intervention in exercise-based CR for improvement of physical capacity, adherence,     psychological and physiological parameters, compared with usual care.   "
29813|NCT02895438|"     Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is     difficult, often resulting in a persistence of chronical abdominal pain.      In adults, many patients affected by IBS improve under a gluten-free diet, even in the     absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten     Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the     pathophysiological mechanisms also remain elusive.      The aim of this study is to determine if NCGS exists in children with IBS and to identify the     clinical, serological, and histological characteristics, which could distinguish patients     with NCGS from conventional IBS and CD patients.      This is a prospective cohort study in a population of children affected by a moderate to     severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks.     Then, children who improved under GFD were randomized in two groups for a double-blind     placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out     period, then a placebo reintroduction, whereas the other group had the placebo first, then     the wash-out and the gluten reintroduction.   "
29814|NCT02895425|"     The rein registry collects case record data from patients with end stage renal disease     followed in French Guiana. This allows to generate incidence and rates for terminal renal     disease, mortality rates for each territory. The regional data are pooled in order to get     national statistics for end stage renal disease and transplantation activity in order to     adapt prevention to the main causes of renal failure and treatment and care infrastructure.   "
29815|NCT02895412|"     This study is to test a new therapy for patients with acute myeloid leukaemia who are     undergoing blood stem cell transplant. In this study, the investigators will take a small     number of your immune cells whose normal function is to give immunity to infections and help     to fight leukaemia. These cells will be stimulated to multiply in the laboratory and will     then be given to the transplant recipient after the transplant. This is a sort of immunity     transplant. The exact purpose of this study is to investigate if these cells are safe and     effective in patients having a transplant for AML.   "
29816|NCT02895399|"     Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have     shown that populations living in remote villages in the interior of the territory have early     sexual relations and that multiple sexual partnerships are frequent. Hence, the main     objective of the study was to determine the prevalence of HPV in these areas, and the     predictive factors and epidemiology of this viral infection.      Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65     years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to     participate will be included after being informed of the study team schedule through radio     address and key opinion leaders. The search for HPV and cytologic examinations will be     performed for each woman. 2 samples will be taken from each woman: one sample will be sent to     Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed     using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in     Cayenne for sequencing and detection of E6 and E7 RNA which are associated with     carcinogenesis. HPV infection will be defined by the detection of viral DNA using the     GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping     will use Mapinfo.   "
29817|NCT02895386|"     To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous     anastomosis in the iliac region (between the iliac artery and vein) in subjects with     hypertension.   "
29818|NCT02895373|"     Bleeding complications and thromboembolic complications are frequent during extracorporeal     membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using     prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing     the bleeding risk. This randomized, double-blind trial aims to investigate the effects of     PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.   "
29819|NCT02895360|"     Single-agent, open-label, multi-center sequential dose escalation and expansion study of     BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced     or recurrent solid tumors.   "
29822|NCT02895321|"     The chief aim of this study is to evaluate the difference in tooth sensitivity after having     used a gel containing nano - hydroxyapatite and potassium nitrate      This randomized double-blind clinical study is designed to compare the efficacy in reducing     dentin hypersensitivity of a toothpaste gel containing Nano-hydroxyapatite and potassium     nitrate (Cavex Bite & White ExSense, Cavex Holland BV) with a fluoride-based gel toothpaste (     Colgate, Protection Caries, Palmolive SPA ).      Specific objectives :      To evaluate through standardized tests the dental sensitivity before and after the     application of toothpastes; To compare the variations of dental sensitivity test and control     groups.      Safety:      determination of adverse reactions, such as increased tooth pain and changes in the oral     mucosa after application of the materials.   "
29823|NCT02895308|"     The aims of this study are to experimentally investigate and compare whether motivation     variables can predict adherence to a prescribed assignment in face-to-face and online     interventions using a psychotherapy analogue model.      A total of 100 participants are included in this study and randomized to either a     face-to-face or online intervention. Participants in both groups receive a psychoeducation     session and are given an assignment for the subsequent week.   "
29824|NCT02895295|"     The objective of this study is to determine whether providing Medicare beneficiaries with a     web-based patient-centered decision tool to help them choose among prescription medication     coverage plans improves outcomes for patients including a greater likelihood of changing a     plan, better coverage for prescribed drugs, less decisional conflict when choosing plans, and     greater satisfaction with the choice process relative to current practice.   "
29825|NCT02895282|"     The main objective is to investigate chronobiological aspects of childhood obesity studying     the potential relationship between meal patterns and circadian rhythmicity in a     cross-sectional sample of obese, overweight and normal weight children/adolescent.   "
29826|NCT02895269|"     COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis     implemented by complementary alternative providers (traditional and faith healers) and     conventional primary health care providers (PHCP) is compared with care as usual in which no     formal collaboration takes place between the two groups of health providers. COSIMPO is     therefore a test of a complex task sharing approach for the care of patients with severe     mental disorders.   "
29829|NCT02895230|"     The research focuses on the safety profile of androgen-deprivation therapy (ADT). The     hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across     the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT     modalities including intermittent ADT.      ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh     improvements in cancer-specific outcomes against potential increased risks for cardiovascular     diseases. The potential for harm from ADT should be more precisely defined according to the     type of ADT. Those potential risks underscore the importance of better understanding benefits     of ADT, especially in contexts where data are still lacking.ADT is also indicated in sexually     deviant behavior.   "
29830|NCT02895217|"     Exercise training on an immersible ergocycle is becoming more popular as it appears to be     more suitable for men and women even with poor physical activity level. Commercial tagline     highlight beneficial effect of this activity on weight management. However there are poor     information concerning the energy response induced by this activity. The aim of this project     is to investigate energetic response (energy expenditure and food intake) of a single bout of     cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.   "
29831|NCT02895204|"     To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on     natural killer (NK) cell activity, circulating cytokines and serum protein levels.   "
29832|NCT02895191|"     Compared with placebo, evaluate the effects and safety of Ulinastatin added to conventional     treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.   "
29833|NCT02895178|"     The purpose of this study is to examine the effects of exercise program on health-related     physical fitness and biomarkers among breast cancer survivors.   "
29834|NCT02895165|"     The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care     and improve knowledge around the topics of fertility preservation and pregnancy issues in     young breast cancer patients. The program was initiated at the National Institute for Cancer     Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been     spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM)     study group. It is composed of two distinctive studies, one assessing fertility (i.e.     PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different     study protocols were developed under the umbrella of the PREFER registry.      PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of     young cancer patients on the fertility preservation strategies available in Italy.     Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for     fertility preservation in terms of success of the techniques (i.e. recovery of ovarian     function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e.     long-term survival outcomes).      PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management     of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children     born after prior in utero exposure to anticancer treatments, and the long-term survival     outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of     breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of     breast cancer.   "
30301|NCT02889146|"     The purpose of this study is to verify if a protocol of early and progressive mobility which     includes the use of technology is able to increase the level of physical activity and improve     functionality and respiratory and muscular function of Intensive Care Unit patients compared     with conventional Physical Therapy.   "
29835|NCT02895152|"     In patients with Chronic Obstructive Pulmonary Disease (COPD) lifestyles with lower physical     activity levels have been shown to increase the risk of hospital admissions and shorten     survival rates. An established process in increasing activity levels is to undergo pulmonary     rehabilitation classes.      The investigators wish to identify whether the use of activity monitors,which will provide     feedback on activity levels, will increase the physical activity levels of patients with COPD     outside of the supervised pulmonary rehabilitation sessions.   "
29836|NCT02895139|"     This study will assess the ability of different orthotic insole treatments to reduce pressure     under the ball of the foot. This is important for people who have diabetes because their feet     are at higher risk of foot problems in this area. This study will involve the participants     wearing a a range of insoles produced by milling, handmade processes and additive manufacture     along with normal orthotic footwear. A researcher will measure the pressures under the feet     while the participants walk wearing the orthotic insoles.   "
29837|NCT02895126|"     In so-called at risk families, the child-parent attachment relationship is more difficult to     set up and this can be a barrier to social and emotional development of young children. To     help parents build and sustain this relationship, and to prevent child development disorders,     many parenting programs have been created, usually with frequent home visits by early     childhood professionals. In France, therapeutic interventions at home are little used and     they are not evaluated.      In Montpellier, an action of this type has been conducted since 2001 by the Conseil     Départemental de l'Hérault in collaboration with the University Hospital of Montpellier     including, in addition to home visits, supervision of professionals: the Appui Parental     Program.      Before extending this action to other areas of Herault, the Conseil Départemental de     l'Hérault, the Abri Languedocien and the University Hospital of Montpellier are conducting     an assessment to know the effectiveness of the program for families under care.      This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from     families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental     program (experimental group) and 44 benefiting a regular support (control group).      A paediatric examination on the basis of the Denver scale, parental questionnaires,     questionnaires to professionals and an a video of infant-parent interactions are used. The     data, collected at baseline and 18 months later, will be compared.   "
29858|NCT02894853|"     We hypothesize that an early molecular profiling, that includes both tissue and blood-bases     analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency.     When molecular profiles are available at an earlier stage of disease, more patients will     benefit from personalized therapy once needed. This will result in both a better quality of     life and outcome.   "
29838|NCT02895113|"     The pathophysiology of diabetes is multifactorial. Beyond genetic susceptibility loci, a lot     of acquired risk factors are involved in the development and progression of the disease.     Chronic complications of diabetes can be divided into vascular and nonvascular. The risk of     developing complications increases with the duration of hyperglycemia, and usually become     apparent in the second decade of hyperglycemia. Vascular complications are further subdivided     into microvascular (retinopathy, nephropathy and neuropathy) and macrovascular (coronary     artery disease, peripheral arterial disease, cerebrovascular disease). It is estimated that     the annual decline of estimated glomerular filtration rate (eGFR) in diabetic adults is about     2.1-2.7 ml/min.      While there is consolidated evidence about the use of aspirin (ASA) for secondary prevention     in diabetic patients, there is no consensus on the use in primary prevention; the use of ASA     in these patients is at physician discretion.      ASA is an effective antithrombotic agent that inhibits the production of thromboxane (Tx) A2     and other prostaglandins by blocking cyclooxygenase (COX). In patients treated with aspirin,     serum TxB₂ level is the most reliable in vivo indicator of COX-1 inhibition than TxA2, due to     its short half-life and artifacts associated with platelet activation ex vivo.      COX are present in the kidney in the macula densa, in the medulla and in the interstitium.     Experimental animals models have demonstrated that COX are involved in regulation of renal     blood flow. In particular, in a murine animal model, after the administration of COX     inhibitors such as aspirin and celecoxib, it was observed an improvement in renal plasma flow     and eGFR, suggesting a role for Tx in the progression of renal damage However, data on the     relationship between aspirin and renal function in humans are scarce. In a recent work lead     on a large cohort of 800 patients with non-valvular atrial fibrillation, ASA use was     associated with a reduced progression of eGFR <45 ml/min during 2 years of follow-up.     Furthermore, basal levels of urinary excretion of TxB2, correlated inversely with the use of     aspirin and with the decrease of eGFR at follow-up.      The aim of the study is to evaluate the decline in renal function in diabetic patients     treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients.   "
29839|NCT02895100|"     The main objectives of this study are to evaluate the efficacy, safety, and tolerability of     daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).   "
29840|NCT02895087|"     Despite advances in AntiRetroviral Therapy (ART) leading to a rapid control of the HIV virus     in individuals affected, HIV can persist indefinitely and there is no cure. The HIV virus has     been shown to have a unique ability to hide within the human gene inside human cells and in     tissues, remaining 'silent' and rapidly reactivate 'waking up if ART is stopped.      There are a number of ways to measure the silent HIV reservoir, including a common     research-based laboratory test called Cell-Associated UnSpliced (CA-US) HIV RNA. This is an     early marker of the HIV virus waking up. It is often used to test how well new drugs     developed to eliminate the silent virus might work.      This study is examining whether the diurnal variation (daily rhythm) and/or stress can affect     CA-US HIV RNA levels in individuals diagnosed with HIV and receiving ART.   "
29841|NCT02895074|"     To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and     conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in     age-related cataracts.   "
29842|NCT02895061|"     Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol     treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective     was to observe the adverse effects between these two treatment regimens.   "
29843|NCT02895048|"     The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with     heart failure.   "
29844|NCT02895035|"     The objective of this study is to compare the maintenance of intraoperative mydriasis during     cataract surgery between two drugs: epinephrine, which has routinely been used for decades,     and Omidria, a newly FDA approved combination drug of phenylephrine and ketorolac. Patients     undergoing cataract surgery that are enrolled in the trial will randomly receive one of the     drugs in one eye, and the other eye will receive the drug during the subsequent cataract     surgery.   "
29845|NCT02895022|"     The need to resort to a midwifery course work in cesarean is a common practice. Epidural     analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the     cesarean decision is taken course work in practice and the recommendations are to use the     epidural catheter in place to convert the epidural analgesia in epidural anesthesia by     re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of     extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal     morbidity and mortality.      The initial assumption is that the 2% lidocaine with epinephrine is the optimal and     recommended local anesthetic solution.   "
29847|NCT02894996|"     To predict fluid responsiveness in anesthetized pediatric patient is not an easy task     although anesthesia provider has to deal with this question on their daily practices. Today,     very few parameters can help anesthesia provider to predict fluid responsiveness in the     pediatric anesthetized patient. Therefore anesthesia provider are let with fluid challenge     with high volume of fluid boluses to see if patient were fluid responsive or not. This could     lead to fluid overload and it's associated morbidity. We would like to investigate if the     cardiac output response to a mini fluid challenge of 3 ml/kg in 2 minutes would be predictive     of the response to an usual fluid challenge of 15 ml/kg in 10 minutes in elective pediatric     anesthetized patients.   "
29848|NCT02894983|"     There is no consensus about the best conservative treatment for patients with dorsally     displaced distal radius fractures. The previous studies that have examined the most valid     method for cast immobilization have lacked uniform and patient-rated outcome measures, proper     randomization and sufficient study population. The aim of this study is to compare functional     position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in     patients aged 65 years or older. The conservative treatment is performed in clinical practice     by various health care professionals with different techniques of reduction which are not     limited to any specific technique in this pragmatic, randomized controlled trial.   "
29849|NCT02894970|"     To evaluate feasibility of photoplethysmography (PPG) of pulmonary arteries in adults     children and neonates and to compare normal controls to premature newborns suffering from     patent ductus arteriosus and neonates suffering from pulmonary hypertension.   "
29859|NCT02894840|"     The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain     per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri     Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.   "
29867|NCT02894736|"     Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation     treatment that is effective with no significant side effects. It can potentially be     self-administered by patients in their own homes with remote monitoring, substantially     reducing treatment costs and increasing accessibility, including to remote areas. This study     will evaluate the feasibility and efficacy of home-administered tDCS treatment for     depression.   "
29850|NCT02894957|"     Rationale: No studies have examined the effect of varenicline for gradual smoking cessation     in COPD smokers currently not interested in quitting.      Objective: To compare the efficiency of varenicline-assisted gradual vs. abrupt smoking     cessation in low-motivated COPD smokers      Setting: Pulmonary outpatient clinic      Design: Open, randomized pilot smoking cessation trial      Participants: COPD smokers with low motivation to quit. Such low motivation will be defined     as a score of ≤ 3 points observed in a 10 cm visual analog scale (0=non motivated; 10=highly     motivated).      Interventions/procedures: Patients will be randomized either to receive varenicline     (uptitrated to 1 mg twice daily) for smoking reduction or smoke as usual for 4-6 weeks before     quitting. After quit-day, the two groups will receive standard 12-week varenicline treatment.     Non-treatment follow-up will continue to 6 months.      Measurements: The main outcome measure is carbon monoxide-verified complete abstinence rate     (CAR) 6 months after quit-day. Other measures are: CAR at 3 months; point prevalence at 3 and     6 months; change in motivation; cigarettes/day; differential dropout rate; decline in     pulmonary function; COPD symptoms, episodes of exacerbation and medication; and adverse     events.      Sample size: One hundred twenty-one subjects per group will be necessary to detect CAR     differences between the two groups of 15% at 6 months.      Potential study limitations: The main potential limitation is the lack of 1-yr follow-up.      Relevance: This study may provide useful preliminary information on the safety and efficiency     of varenicline for gradual smoking cessation in low-motivated COPD smokers and it may     assist in the preparation of a larger, more comprehensive trial.   "
29851|NCT02894944|"     Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival     probability of less than 5% when all stages are combined. At present, only approximately     10%-20% of patients are considered candidates for curative resection. The majority of     patients (50%-60%) are present with metastatic disease, and substantial number of patients     (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.      Replication-competent Adenovirus-mediated Double Suicide Gene Therapy     (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic     cancer in phase I study. From the experience of prostatic cancer, the safety of combination     with standard chemotherapy with Theragene treatment is assessed in this study.   "
29852|NCT02894931|"     While previous atherosclerosis-related studies have focused mainly on the atherogenicity of     lipids, the proposed study aims to investigate the effects of other dietary factors, i.e.     monosaccharides, disaccharides, amino acids, or artificial sweeteners, on the atherogenicity     of serum or macrophages. Findings from the current proposed study may shed light on yet     unknown mechanisms by which the above dietary factors could affect atherosclerosis     development and CVD risk and hence could possibly assist in the future development of     anti-atherogenic strategies.   "
29853|NCT02894918|"     This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with     nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This     study is a Randomized, open-label, multi-center study.      The CHB patients with NAs treatment and have achieved HBV DNA <15 IU/ml、HBeAg <100     PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml will be randomized into 2 groups:      Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by     Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49     weeks. Note: NAs including: LAM, ADV, ETV, or TDF.   "
29854|NCT02894905|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of     AL-335 in participants with various degrees of impaired renal function (mild, moderate, and     severe) compared to participants with normal renal function.   "
29863|NCT02894788|"     Several score systems were created to stratify perioperative risk and predict mortality. The     study rises from the needing of a rapid and simple system to identify the patient worthy of     Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated     on patients underwent to elective surgery searching for determining factors (DFs) for     postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict     the admission in ICU of consecutive patients scheduled for elective surgery during a     three-months period and created an index, named PoIS (Post-operative Intensive Surveillance),     based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes     Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI),     age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of     the original model. Authors classified SI from G1 (lowest) to G5 (highest).      The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM     resulted coincident and better than the American Society of Anesthesiology scoring system.   "
29855|NCT02894892|"     Gastric cancer is one of the leading causes of cancer-related deaths worldwide. In Taiwan,     there are around 3800 fresh cases annually, with about 5% of total cancers cases. Gastric     cancer development is known to follow a multistate process from non-atrophic gastritis,     atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; H. pylori infection     plays the key role of this carcinogenic process. Although H. pylori eradication would result     in a marked gastric cancer reduction, treatment success using standard regimens has become     more difficult in recent years, and increased antibiotic resistance is considered the most     important reason for decreased treatment efficacy. As no specific new medications have been     introduced in recent years, novel treatment regimens have been created using different     combinations, durations and sequences of available medications. The addition of bismuth     improved the cure rates despite a high prevalence of resistance, and resistance of H. pylori     to bismuth has not been reported. Bismuth absorption is not required for efficacy in H.     pylori treatment regimens, suggesting a local mechanism of action. The mechanisms of bismuth     with responsible for rapid destruction of H. pylori within the stomach remain unclear.     Knowledge of the mechanism of action of bismuth compounds against H. pylori would be     beneficial in the development of improved treatment regimens in this era of declining     eradication success rates. We conduct the pilot study to evaluate the bacteria fragments of     H. pylori in specimen through electron microscopy after bismuth therapy and provide insight     into the mechanism of action of pH on bismuth therapy. We also help to develop optimal H.     pylori therapeutic strategies.   "
29856|NCT02894879|"     The purpose of this study is to explore effectiveness of modified chest physical therapy     techniques using new device in pre and post-operative program in patients undergoing open     heart surgery   "
29860|NCT02894827|"     Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a     medication and digestive tolerance are ensured, the medication can be taken a long time from     meals to reduce its side-effects. Despite numerous studies that have investigated links     between medication and malnutrition, none have assessed the influence of the time the drug is     taken on the evolution of the nutritional status of elderly hospitalized persons. So as to     identify the best nutritional criterion in hospitalized persons, a retrospective pilot study     will be conducted in about thirty patients. Their medication will be recorded and their     nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI),     albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short form.      This preliminary study will allow us to choose the best nutritional criterion to compare the     impact of two strategies for taking medication (post prandial versus pre-prandial) on     improving the nutritional status of malnourished elderly hospitalized patients taking     multiple drugs.   "
29861|NCT02894814|"     The primary purpose of this study is to investigate if patient involvement in the medication     procedures through elements of the medication system One-Stop Dispensing (use of own     medication, placed in bedside locker, partly or self-administration of medication) and     focused dialogue about medication can maintain or improve the patients' health literacy to     perform the prescribed medical treatment during and after hospitalization.      The hypothesis is, that involving the patient in the medication procedure and focused     dialogue about the medicine during hospitalization will improve the patients' health literacy     measured by patient adherence, patient knowledge and perceptions of safety about the     medication. It is further expected that more time will be spent together with the patient,     and that the new medication procedures will be cost-neutral.   "
29862|NCT02894801|"     Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In     France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57% in     men to 60% in women. About one third of patients diagnosed with CRC will develop a     metachronous recurrence during the following years. It is of paramount importance to     accurately identify factors associated with the increased risk of progression and death, in     order to develop effective follow-up and treatment strategies. However, to accurately assess     the role of patients' specific characteristics in the progression of cancer several     methodological challenges need to be overcome.      One difficulty, common to prognostic studies of cancer, concerns the need to separate the     effects of prognostic factors on different clinical endpoints, such as disease recurrence vs     recurrence-free death. Another difficulty, encountered in prognostic studies, is that the     cause of death is not available or not accurately coded. Yet, some patients are likely to die     of causes not related to the disease of primary interest, especially in cancers with longer     survival and in those that affect older subjects. Until recently, the existing statistical     methodology was not able to simultaneously, deal with both difficulties, i.e. to account for     (i) possibly different effects of prognostic factors on death vs recurrence, and (ii) unknown     causes of death. However, this challenge has been addressed by the recent development of the     Markov relative survival model (MRS) , which extends the Markov multi-state model to     incorporate relative survival modelling. Simulations demonstrate that MRS is able to     accurately estimate different effects of prognostic factors on the risk of each of several     events, including separate effects on disease-specific vs other causes of death. To date, the     MRS had not been applied in clinical or epidemiological studies.      The aim of this study was to assess the potential advantages of the new multi-state relative     survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To this     end, we compared the MRS results with those obtained with two more conventional analyses,     based on Cox's proportional hazards model, and the multi-state Markov model proposed by     Alioum and Commenges (2001). The three models were applied to explore the impact of     prognostic factors on cancer-specific mortality and recurrence, in a large population-based     French registry of colorectal cancer, with up to 25 years of follow-up.   "
29876|NCT02894619|"     This observational study evaluates prevalence of functional perinea disorders (stress urinary     incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients     of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal     symptoms ; assess their impact on patients' quality of life, sexuality, care and social life     and relationships ; identify the medical and demographic factors associated with the severity     of urinary and anorectal disorders and their impact and determine the relationship between     the severity of these disorders, various repercussions, and risk factors.   "
36044|NCT02813993|"     Recent evidence has shown that young people that want to have children have low fertility     knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge,     on changes in lifestyle and on the decision to start to get pregnant.   "
29864|NCT02894775|"     Since the early 1990s, evidence-based medicine has played an increasingly important role in     decision-making for the treatment of patients with cancer. The highest level of evidence is     attributed to the results of randomized comparative studies, and the public health     authorities require proof from randomized therapeutic trials before authorizing the use of     new treatments. Patients included in therapeutic trials benefit either from the best current     treatment (control group) or from a treatment supposed to present a better or similar     efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a     randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize     the fight against cancer, French public health policies have led to the progressive     implementation of successive nationwide Cancer Plans since 2003. One of the objectives is     to increase the proportion of patients included in clinical research trials. Thus, the     fraction enrolled in France has progressively increased but remained low at around 8% in     2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a     context of socio-economic inequalities that concern resources, residence and access to     services, identifying factors that determine inclusion in trials will in turn highlight the     reasons for non-inclusion.      The aim of this study was to determine, at a population level, the influence of demographic     characteristics and socio-economic status of patients with digestive cancer on inclusion in a     clinical trial.      Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry.     According to a balancing score, the 136 patients included in a clinical trial were matched     with 272 patients who met the eligibility criteria for trials. Deprivation was measured by     the ecological European deprivation index. A conditional multivariate logistic regression was     performed.   "
29865|NCT02894762|"     This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla     Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical     Chemistry Analyzer.      Analyte Principle:      Albumin (ALB) - Dye-Binding BCG      Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)      Glucose (GLU) - Hexokinase, Colorimetry      Total Protein (TP) - Biuret   "
29866|NCT02894749|"     This is a randomized prospective monocentric study to evaluate the benefits of a 3D     rotational acquisition (3DRA) to assess technical success after treatment of infra-renal     aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy     (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new     strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation     exposure and contrast medium used during the hospital stay, with a similar resolution between     angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking,     endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an     additional procedure during the same operating time, and therefore avoid a second     intervention for the patient.   "
29868|NCT02894723|"     Essential Hypertension is characterized by endothelial dysfunction due to reduced nitric     oxide (NO) bioavailability. Impairment in nitric oxide-mediated vasodilatation in human     brachial, coronary, and renal arteries has been demonstrated in patients with essential     hypertension. Administration of L-arginine, a NO substrate yeld controversial results.      The purpose of the present study, double blind and matched for age, sex and body mass index     (BMI), is to assess the efficacy of L-arginine treatment on blood pressure (BP) control and     arterial stiffness in patients with stage1 hypertension.   "
29869|NCT02894710|"     Lidocaine, local anesthetic used for more than five decades, is being intravenously     administered aiming at managing pain in different types of surgeries with promising results.     Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to     the difficulty of locoregional anesthesia and high level of opioid consumption.      This randomized study aims to compare quality of perioperative analgesia after infusion of     intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to     evaluate morphine consumption during the 48 postoperative hours.      Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption     during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months     after carcinologic ENT surgery, and incidence of side effects that can be attributed to     lidocaine infusion.   "
29870|NCT02894697|"     Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would     increase the risk of adverse events including late stent thrombosis. OCT-guidance may improve     more optimized scaffold placement and also better outcomes. However, there is still no     sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it     should be more evaluated in real practice. In the study, the investigators will evaluate an     incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.   "
29871|NCT02894684|"     This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of     CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV     anti-pseudomonals.   "
29872|NCT02894671|"     The study has as general objective to analyze in the adult population, (male and female) the     presence of a very common protein, in its normal form and modified, isolated from the blood     of patients and called albumin. The opportunity to observe the distribution of this protein     in the population, provides the basis to be able to perform this type of assay also in the     population of patients with pathologies, in the near future, with the aim of increasing     knowledge on the subjective tolerability to orthopedic implants.   "
29873|NCT02894658|"     The LipiFlow System (TearScience, Morrisville, NC) is an in-office FDA approved treatment for     meibomian gland dysfunction. It relieves meibomian gland obstruction through the use of heat     and pulsatile pressure. A recent study has observed that a single treatment with the LipiFlow     system can decrease dry eye symptoms and objective findings of meibomian gland dysfunction     for 1 year. We aim to see if the Lipiflow System will be beneficial in patients with     Parkinsons disease who may have difficulty performing normal meibomian gland dysfunction     treatment.   "
29874|NCT02894645|"     The overall objective of this study is to continue to improve the cure rate of childhood     acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre     cooperative trial using a risk-stratified therapy based primarily on early response to     therapy utilizing a simplified minimal residual disease (MRD-lite) platform.   "
29875|NCT02894632|"     A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing     (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to     model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to     simplify patient installation.   "
29880|NCT02894567|"     The purpose of this study is to provide proof-of-concept that directional stimulation and     directional recording, in an intraoperative setting, is perceivable in a subject. The tests     will be performed using a dedicated intraoperative lead connected to an external     neuro-recorder/stimulator, during a deep brain stimulation implantation surgery.   "
29881|NCT02894554|"     The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported     from 3% to 20.9%. And patient survival and graft survival rates following renal     transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients.     Due to viral replication in asymptomatic HBV carriers induced by post-transplant     immunosuppression, liver-related complications, such as liver failure and bleeding, account     for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.      Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated     antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal     allograft recipients has significantly improved patient survival rates during short-term     follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with     chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related     decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR     increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine     treatment.      However, limited results were known about the renal function affected by oral anti-HBV drugs     when patients received kidney transplantation. Therefore, we would like to conduct this study     to evaluate the renal function of Lamivudine long term used HBsAg positive patients received     kidney transplantation after switch to Telbivudine treatment. The clinical and virological     outcomes will provide valuable insights of clinical practice.   "
29882|NCT02894541|"     The purpose of this study is to investigate the effects of food on the     pharmacokinetics/pharmacodynamics of CKD-519.   "
29883|NCT02894528|"     Fifteen patients were selected, each presenting at least two jaw front teeth indicated for     extraction: in the Test Group (TG), post-extraction sockets was filled by synthetic bone     substitute ReproBone, and in the Control Group (CG) the socket was filled only by clot. In     both groups, the sockets were covered by a resorbable collagen membrane BioMend, which in     turn was covered by a flap. Computed tomography scans were acquired in the immediate     postoperative period and 6 months after surgery, and the horizontal and vertical dimensional     changes in bone crests were quantified.   "
29884|NCT02894515|"     The purpose of this study is to investigate whether 2 different tablet compositions are     similar regarding absorption (uptake) in the body. One composition was used in the clinical     development program and the other is intended for the market   "
29885|NCT02894502|"     The aims of this study will be to evaluate the effect of motivational interviewing (MI) to     improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care.     Also this study will evaluate the effect of MI on the following secondary outcomes: In HF     patients: HF somatic symptom perception, generic and specific quality of life, anxiety and     depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency     services, and mortality; In caregivers: generic quality of life, anxiety and depression,     mutuality with patient, preparedness, social support and sleep quality.   "
29886|NCT02894489|"     Our study is aimed to observe the long termed effect of contact lens wear on ocular surface,     especially focused on visual function and ocular inflammation mediators.   "
29887|NCT02894476|"     The SUBUSQOL cohort aimed to improve knowledge of the quality of ambulatory care, in     particular the prognostic role of the early satisfaction with care on the change from     baseline quality of self-reported health status in outpatients with alcohol or opioid     dependence. It is a multicenter prospective cohort. Satisfaction was assessed using a     multidimensional self-administered and validated questionnaire during the early care process.     In addition to measuring satisfaction and obtaining sociodemographic and clinical data, this     study collected data on the self-reported health status at inclusion and 3, 6 and 12 months     after inclusion.   "
29888|NCT02894463|"     The aim of this study is to evaluate the potential risk of abusive behavior for children in     care using nitrous oxide for dental care.   "
29889|NCT02894450|"     The objective of this study was to investigate whether there is a link between clinical and     biological variables and bioassay high xaban in elderly patients as part of an unscheduled     hospitalization.   "
29890|NCT02894437|"     The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network     of SCI patients whose general organization refers to the medical literature and the     recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work     (CFW) will be set up and semi-structured interviews will be conducted with patients and     professionals. They will confirm or dismiss the CFW gradually with a refined coding As of     domains and sub-domains of the skin preventing spinal cord injury related to the perceptions     and behaviors of those involved in the sector. Quality control will be provided by experts in     qualitative research and interviews will be stopped when the analyzes will further refine the     domains and subdomains. A final framework will be validated to modulate our organization.   "
29899|NCT02894320|"     The ability to predict sensory effects of people's own motor actions is a key component of     Human action realization. Recent studies revealed this anticipation process to be involved in     early and late stages of voluntary actions. Nevertheless, the question whether the     action-effect anticipation is impacted or not by motor pathologies, such as the Parkinson's     disease, remains unclear. The current study is aimed to clarify this issue by using a     subliminal priming paradigm in patients with Parkinson's disease and in matched control     participants. Indeed, subliminal primes corresponding to visual action-effects are displayed     at different time points before the actions' execution. Results should allow to determine     whether or not the action-effect prediction is impaired at different stages of voluntary     action in patients with Parkinson's disease.   "
29925|NCT02893982|"     The objectives of this study are to demonstrate feasibility of an optimized, image-guided     pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while     maintaining established dose constraints to normal tissues, and to determine the maximum     tolerated dose (MTD) while evaluating treatment delivery, safety, and efficacy utilizing a     pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver     lesions.   "
29891|NCT02894424|"     The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects     at least two persons in 1000 after 40 years.      This hole causes an acute decline linked to a central scotoma. The only treatment is     surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the     tensile forces. To be sure the removed is complete and to facilitate the closure of the hole,     a peeling of the internal limiting, the outermost layer of the retina, is often suggested.     The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with     vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma     disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described.     This sensitivity decrease could be induced by the dyes used during surgery.      This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant     Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher     concentrations, at least on the isolated retina models.      It would be interesting to search for a decrease in retinal peri-foveal postoperative     sensitivity after surgery of macular holes, performed with the usual dyes. Only     microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive     technique that explores the macular visual field. It is performed without iris dilatation and     allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.   "
29892|NCT02894411|"     The paralysis of the fourth cranial nerve (paralysis IV), commonly known as the superior     oblique muscle (SO) paralysis, represents half of vertical strabismus. The diagnosis of SO     paralysis and of its congenital or acquired etiology, are based on a range of clinical     findings. The three main clinical diagnostic elements are the hypertropia in paralyzed side     which increases in adducted position, the positivity of Bielschowsky head tilt test and the     twisting of the eye fundus. These criteria are always considered together and are     interdependent. The diagnostic value and the sensitivity of each of these signs is not     defined. Brain and orbital Magnetic Resonance Imaging (MRI) allowed a better understanding of     the physiopathology of a number of oculomotor disorders.      For this reason, MRI constitute a reference for the SO palsy. The atrophy of the SO muscle is     qualitatively determined by the asymmetry of muscle volume on two contiguous coronal MRI.      The diagnostic value of various clinical signs observed in SO paralysis (sensitivity,     specificity) remains unknown.   "
29893|NCT02894398|"     The purpose of this study is to evaluate the efficacy and quality of life in women with     advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the     breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline     therapy in combination with palbociclib (Ibrance)   "
29894|NCT02894385|"     Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety     and tolerability of BAY 1841788 (ODM-201).   "
29896|NCT02894359|"     Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary     neck muscle activity causing abnormal head postures and movements. It is the most frequent     form of adult focal dystonia. The distribution of dystonic muscles is unique for each     patient, explaining the variety of patterns encountered.      The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin     injections and/or specific retraining therapy programmes. Therefore, analyzing the     characteristics of abnormal head movements and identifying the dystonic muscles are the key     points of these treatments.      To a better understanding of the posture and movement disorders of head and neck, we wish to     establish a three-dimensional (3-D) computer model of cervical spine movements of ten healthy     subjects built from images obtained with the Cone Beam  system. Then we will compare the     cervical posture and movements for each of ten CD patients matched in age and genre to the     computer model. Comparison with patients' images in the axial plane reconstructed by computer     with the 3-D computer model will lead to the description of various patterns of CD. Analysis     of the musculoskeletal disturbances in CD should be a help to improve the localization of     Botulinum Neurotoxin injection sites as well as retraining programmes.   "
29897|NCT02894346|"     Since 2014 45 minutes of physical activity (PA) has been a mandatory part of all public     schools in Denmark. PA has to be part of subject teaching, including Physical Education (PE),     and of so-called support teaching. Research has shown that teachers not always find it     meaningful to implement PA during lessons. In addition, even though PA seemingly has positive     impacts on children's concentration and learning, teachers find it hard to integrate good     quality PA with the learning objectives of any school subject. The purpose of this study is     therefore to: 1) Analyse teachers' underlying factors of motivation for using PA as a     learning tool using The Self Determination Theory (SDT), and 2) analyse how to support     teachers' motivation by using the theory of scaffolding.      The study uses mixed methods. Through quantitative and qualitative methods the study analyses     behavioural patterns focusing on teachers' motivation for implementing PA and need for     support. The process is iterative moving from a quantitative (survey) to a qualitative     approach (interviews).      The study provides new and important knowledge of teachers' motivation for implementing PA as     a learning tool. Results from SDT analysis will point out teachers' levels of controlled     versus autonomous motivation, and analysing teacher's need for scaffolding will give insight     into how teachers' motivation can be framed in the process of implementing PA.      There can be both potentials and barriers for implementing PA in a learning context, and in     the process of implementing PA during school days the role of the teacher becomes crucial. It     is therefore important to understand teachers underlying factors of motivation for using PA     as a learning tool, and in order to help them carry out qualified and suitable PA, it is     important that the investigators know how to support them and maintain their motivation in     this process.   "
29898|NCT02894333|"     The ideomotor theory of action control is considered to be central to the understanding of     human voluntary action. According to the ideomotor theory, an action is represented in terms     of its desired sensory effects and actions are selected by internally activating these effect     representations. Recent imagery and behavioral studies showed that this anticipated     representation of action-effects triggered a sensory attenuation, meaning a decrease of     perceptive performances or a decrease of sensory event-related potentials (ERP) for an     expected event. Thus, the sensory attenuation constitutes a relevant behavioral tool to     investigate sensory anticipation impairment in patients with Parkinson's disease. In a     behavioral paradigm, patients and matched control participants have to perform a perceptive     task on predicted visual action-effects mixed with mispredicted visual action effects.     Performances should be better in mispredicted visual action effects for control participants     only.   "
29988|NCT02893163|"     The primary purpose of this trial will be to test the effectiveness of CHANGE intervention to     increase physical activity, improve diets, reduce obesity and reverse Metabolic Syndrome     among adult patients identified as at risk for cancer due to diet and physical activity     behaviours when implemented in typical primary care settings within the Alberta context.   "
29900|NCT02894307|"     Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients     with atrial ﬁbrillation or prosthetic heart valve and the incidence of death and recurrences     in patients with VTE. Warfarin and similar vitamin K antagonists (VKA) have been the standard     therapy for patients with a metallic valve, or bioprosthesis with atrial fibrillation (AF).     The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial     comparing dabigatran etexilate to warfarin was the only randomized controlled study in     patient with mechanical valve prosthesis, but it was terminated prematurely because of an     excess of thromboembolic and bleeding events among patients in the dabigatran group. To date,     novel oral anticoagulants (NOACs) have shown to be not both safe and or effective for     patients with mechanical valves.   "
29901|NCT02894294|"     Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health     Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although     randomized controlled trials have shown SMC to be highly effective, evidence and experience     from routine implementation of SMC has been lacking. For these reasons, we conducted a     comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection     and disease and anemia when delivered through routine programs using existing community     health workers in the Kayes region in Mali. Our evaluation used a pre-post design with     cross-sectional surveys and abstraction of routine health information system data in an     intervention district (Kita) where SMC was implemented through the health system, and a     comparison district (Bafoulabe) where SMC was not implemented.   "
29902|NCT02894281|"     Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It     causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis     confirmation is important to start proper treatment, because a NORB is often the first     symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to     define by a non-expert ophthalmologist.      The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to     a large inter-individual variability, the dynamics of the pupillary light reflex and its     latency are more reproducible. An easy way to study the dynamics of the pupillary light     reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the     conduction in the visual afferent pathways related to demyelination plate increases the     latency of the pupillary light reflex and decreases the frequency of the PCT.      Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to     evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease     in the frequency of the PCT in NORB, compared to the frequency observed in subjects     ophthalmological or neurological disease, could help developing methods to study the     conduction of the visual pathways with portable devices used during the standard     ophthalmologic consultation and quickly orientate patients to specialized centers.   "
29903|NCT02894268|"     Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue     treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is     superior of tailored therapy as rescue treatment for helicobacter pylori Infection after     failure of several therapy.   "
29904|NCT02894255|"     This prospective multicenter registry evaluates the efficacy of hybrid coronary     revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous     coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is     to be performed in the left anterior descending artery and the left circumflex artery using     only arterial grafts, whereas PCI is to be conducted for the treatment of significant     stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This     research plans to involve patients scheduled for coronary revascularization for multivessel     coronary artery disease who consent to participate in the registry.   "
29905|NCT02894242|"     This investigation is designed to evaluate the performance as well as the patients overall     acceptance of the mask.   "
29906|NCT02894229|"     The primary purpose of the present study is to investigate the relationship between     mindfulness and stress habituation. The investigators propose to measure the effect of     mindfulness on stress habituation by randomly assigning participants to a 6-week     mindfulness-based stress reduction group intervention, a cognitive-behavioral skills group     comparison intervention, or a waitlist control condition followed by repeated acute     psychosocial stress testing (2 laboratory sessions on 2 separate days). Saliva will be     collected from participants throughout both laboratory testing sessions to measure HPA axis     activation (an essential stress-responsive system), along with other measures of     physiological and psychological stress (e.g., heart rate, blood pressure, emotions).     Mediators and moderators of treatment outcome will be examined. The cognitive-behavioral     skills group condition is an appropriate comparison group due to the well-documented efficacy     of cognitive-behavioral interventions on stress.   "
29907|NCT02894216|"     The investigators retrospectively reviewed all radionuclide shuntographic tests using     (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in     nuclear medicine department of Far Eastern Memorial Hospital. The results of shuntography     were evaluated visually and qualitatively, and correlated with clinical follow-up. The tests     were interpreted as normal and abnormal, including complete distal obstruction, partial     distal obstruction or miscellaneous. Clinical outcomes within 30 days were defined based on     subsequent need for revision, re-implantation or adjustment of shunt pressure. Then the     investigators calculated the sensitivity (Se), specificity (Sp), positive predictive value     (PPV), negative predictive value (NPV) and overall accuracy.   "
29923|NCT02894008|"     This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in     patients with persistent post kala azar dermal leishmaniasis (PKDL).      This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral     and cellular immune responses generated by the candidate vaccine in patients, and observe any     clinical changes in the disease over a 42 day period following vaccination.      Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight     volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp     or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB & CTSC     review.   "
30838|NCT02882087|"     This is a phase Ⅱ, placebo-controlled, multicenter, dynamic randomized, double blind study of     the efficacy and safety of RC18, a recombinant human B lymphocyte stimulating factor     receptor-antibody fusion protein in subjects with inadequate response of TNF-α antagonists     due to treat moderate and severe rheumatoid arthritis.   "
29908|NCT02894203|"     The investigators aim to explore the psychobiological effects of a 5-day meditation     intervention on offenders within dangerous and severe personality disorders (DSPD) unit at     HMP Whitemoor. DSPD unit accommodates offenders with psychopathy or with two or more     personality disorders. DPSD unit provides them with a 5-year rehabilitation programme that     consists of group and individual therapy and aims to improve their self-regulation.      This project includes a total of 60 participants and has two major methodological     innovations. First, it will include yoga as an active control group that will be matched to     the meditation intervention (which means it will have the same length and the same social     components) and a passive control group that will be following their usual regimen. Thus, the     effects of meditation will be contrasted with another type of intervention and with not     receiving any intervention.      The second methodological innovation is the combination of psychological and biological     measures. Psychological measures include questionnaires (emotion regulation, mindfulness,     stress) and cognitive measures (attention,empathy,behavioural control). Biological measures     include EEG to measure brain activity related to empathy; gene expression and protein     interlukin-6 to measure changes in immune system; and stress related hormone cortisol. The     investigators also aim to determine to whom does meditation benefit the most by exploring how     initial expectations of meditation, personality, mood and previous life adversity predict     outcomes of meditation or yoga. The data will be collected at three time points: at baseline,     immediately after and 10 weeks after the 5-day intervention.      The investigators expect that meditation and yoga will similarly improve mental and physical     health. If this hypothesis are confirmed, these results will extend previous findings on the     benefits of meditation and yoga to vulnerable populations, and would provide a cost-effective     addition to prisoner rehabilitation.   "
29909|NCT02894190|"     The main aim of this study is the development of the Beliefs about Ventilation Questionnaire     (BVQ).   "
29910|NCT02894177|"     Difficult weaning from ventilation and extubation failure are major issues in intensive care,     concerning 30% and 12% of patients respectively. These can be partly explained by the lack of     accuracy of spontaneous breathing trial (SBT) failure criteria to predict extubation failure.     The investigators performed a pilot study to evaluate transcutaneous carbon dioxide pressure     (tcPCO2) monitoring during SBTs. The results showed that the difference between maximum and     initial tcPCO2 (or ΔtcPCO2) was significantly higher in the group of patients who failed SBTs     according to the usual criteria. Moreover, the results suggested that ΔtcPCO2 could be an     accurate and early criterion for SBT failure. The size of the study could not examine ΔtcPCO2     regarding extubation failure. Therefore, the main objective of this study is to determine if     Δ tcPCO2 during SBTs is associated with extubation failure.   "
29911|NCT02894164|"     This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during     intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are     performed.      The purpose of the study is describe renal function in AKI survivors at follow-up.      Additional aims are to determine how well admission values of renal function markers perform     as predictors of renal function at follow-up and whether estimates of renal function at     follow-up differ depending on which renal function marker is used.   "
30490|NCT02886624|"     The purpose of this study is to assess the rate of sustained virological response (SVR) 12     weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in     patients with acute hepatitis C genotype1 or 4 and co-infected with HIV.   "
29912|NCT02894151|"     The primary objective : To compare effectiveness of pain control in endometriosis associated     pelvic pain between LNG-IUS and DMPA The secondary objective : To compare vaginal bleeding     pattern, side effect, continuation rate, satisfaction and quality of life between LNG-IUS and     DMPA in treatment of endometriosis associated pelvic pain   "
29913|NCT02894138|"     In this study the investigators test the hypothesis that alteplase given intra coronary after     PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and     impaired microvascular function defined as a value of index of microvascular resistance (IMR)     >30.   "
29914|NCT02894125|"     Low back pain is considered to be chronic if it has been present for longer than three     months.      This pathology is extremely frequent with an annual incidence between 5 in 10 % of the     general population. Thus she is frequently met in general medicine, in particular to the     ageing subject. It is the 2nd motive for consultation.      The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great     majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption     of care, in private individuals.      The primary objective of this study is to determine the impact of a 3 months SPA Therapy on     the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy     of 3 weeks to Neyrac-les-Bains.   "
29915|NCT02894112|"     Epidemiological studies indicate that risk of type 2 diabetes is lower when milk is consumed     in the regular diet. Milk products are unique in that they produce high insulin response     despite their low glycemic index. The general aim of the proposed study is to determine the     effect of fluid milk on attenuating the postprandial surge in plasma glucose and triglyceride     after meals and its associated physiological mechanisms. The investigators hypothesize that     the consumption of one or two servings of non-fat milk added to a standard oral glucose     tolerance test (OGTT) solution or the high fat tolerance test meal will attenuate     postprandial hyperglycemia and triglyceridemia. The investigators hypothesize that the     postulated improvement in postprandial metabolic response due to the consumption of fluid     milk will be associated with increased postprandial insulin secretion as well as     insulin-mediated endothelial vasodilation and whole-limb perfusion.   "
29916|NCT02894099|"     In adults, the sedentary behavior was related to cardiovascular risk markers, regardless of     the level of physical activity (PA). However, the interruption of prolonged sedentary time     has shown positive results even when performed in breaks of low intensity and short duration     of activity. The aim of this study is to analyze the influence of a sedentary uninterrupted     period, as well as different forms of breaks in sedentary time for the glycemic, insulin and     inflammatory markers responses in older adults. This is a controlled clinical trial to be     conducted in older (≥ 65 years) and sedentary (<150 min / week of moderate to vigorous     physical activity) people. Those with BMI ≥ to 35.00 kg /m2; diabetic, on medication for     glycemic control, or with absolute or relative contraindications to PA practice will not be     included . Participants will undergo four phases of intervention separated by an interval of     7 days: (1) Prolonged Sitting Time(PST), in which older people will stay for 5 hours seated;     (2) Prolonged sitting with PA of light intensity and short duration (LiSd), time sitting is     interrupted for PA bouts of 50-60% of the Heart Rate (HR)max; (3) Prolonged sitting with PA     of moderate intensity and short duration (MiSd), time sitting will be interrupted for PA     bouts of 65-75% predicted HR max; (4) Prolonged sitting with PA of moderate intensity and     long duration (MiLd,) time sitting will be interrupted with PA bouts of 65-75% of HRmax. PA     bouts will be performed by walking into a hallway every 20 minutes of sitting time and will     last 2 minutes, except in MiLd phase (10 minute breaks every 75 minutes). To evaluate the     effects of different PA interruptions in plasma glucose, serum insulin and inflammatory     markers, blood samples will be collected serially (-30min, Baseline and 30min, 1h, 2h, 3h, 4h     and 5h after a standardized meal. It is expect that interruption of sedentary time, even with     breaks of short duration and light intensity can bring benefits to cardiovascular risk     markers even in the elderly.   "
29924|NCT02893995|"     This is an open-label, multicenter, parallel, randomized (1:1 Slow Dose Titration Group;     Rapid Dose Titration Group), two-group study to evaluate the safety, tolerability,     pharmacokinetics and efficacy of slow and rapid dose titration regimens of subcutaneous     Remodulin infusion in subjects with pulmonary arterial hypertension (PAH). The study will     include about 50 subjects at up to 10 clinical trial centers in China. The treatment phase of     the study will last approximately 16 weeks. Subjects who complete all required assessments     will also be eligible to enter a long-term open-label, extension study (CVT-CV-004).   "
29917|NCT02894086|"     Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about     80,000 cases a year (in France). It mainly affects young adults but is associated with a low     complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of     care in which the patient is hospitalized for less than 12 hours and does not stay overnight     in hospital.      Ambulatory care is based on the guidelines issued by three French learned societies (the     SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national     priority.      The literature data show that 20% of patients undergoing appendicectomy for acute     appendicitis can be treated on an ambulatory basis. However, the success factors for     short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours)     have yet to be identified.      The investigators thus intend to perform a retrospective study of data from the PMSI French     national hospital information system, in order to identify factors that are predictive of a     length of hospital stay below 24 hours in patients having undergone appendicectomy for acute     appendicitis during 2013 in France. The objective is to define the population of patients     that could potentially benefit from ambulatory care.   "
29918|NCT02894073|"     Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in     anaesthesia and perhaps even in the field of medicine as a whole. This procedure may be     challenging in the obese patient - even for the most experienced healthcare professionals.      In a study, PVC placement was considered to be difficult in 46% of obese patients but only     13% of non-obese patients.      Placement of a central venous catheter is an option when PVC placement is impossible,     although central access is associated with a non-negligible risk of complications     (pneumothorax, infection, arterial puncture, etc.).      Facilitating peripheral venous access in obese patients should shorten the time required for     PVC placement, decrease the number of perfusion attempts (a source of dissatisfaction and     discomfort for the patients) and limit the use of a central venous catheter.      Although a number of novel vein visualisation devices (such as the VeinViewer®Vision from     Christie Medical) have been developed to guide PVC placement, there are no literature data on     the value of these devices in the management of difficult venous access in obese patients.   "
29929|NCT02893930|"     This phase II trial studies how well sapanisertib works in treating patients with pancreatic     neuroendocrine tumor that has spread to other places in the body, does not respond to     treatment, or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or     shrink tumor cells by blocking some of the enzymes needed for cell growth   "
29919|NCT02894060|"     Cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents)     are one of the main causes of mortality in the general population. The recruitment of     macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated     LDL (LDLox) leads to the accumulation of cholesterol esters and the formation of foamy cells     characteristic of fatty streaks, the first phase of atherogenesis. These fatty streaks are     rarely followed by clinical events, but can progress to complicated atheromatoses     (calcification, rupture) resulting in the occurrence of various clinical events such as     myocardial infarction and cerebro-vascular accidents (CVA). Once oxidated, LDL becomes     immunogenic and induces anti-LDLox antibody production that could be markers of progression     of atherosclerosis. During LDL oxidation, a multitude of specific oxidative epitopes (SOE)     such as oxidated phospholipids (PLox) and malondialdehyde-lysine epitopes (MDA) are     generated. In order to measure the level of markers in the blood, researchers developed a     series of immunologic levels in vitro, using specific antibodies directed against     well-defined epitopes. Recently, it was shown that Lp(a ) would be the preferred transporter     of these PLox. In fact, several clinical studies show a strong correlation between PLox/apoB     concentrations and Lp(a). This marker (PLox/apoB) predicts future morbidity and mortality due     to cardiovascular diseases, including CVA, up to 15 years in advance, independent of all     other known risk factors. CD36 is a scavenger receptor that recognizes LDLox, but more     specifically PLox present in these lipoproteins .One soluble form of inflammatory CD36     (sCD36) was recently identified. In this study, only healthy volunteers were recruited in     order to be able to establish normal serum ranges of different immunologic biomarkers.   "
29920|NCT02894047|"     Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in     adults. The erosive damage influences the functional prognosis in patients with RA. At     present, there are no sufficiently sensitive and specific predictive markers of erosive     damage.   "
29921|NCT02894034|"     Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence     (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).      Prognostic tools are indispensable in guiding and optimizing the care of these patients.      Some diagnostic factors have been identified (e.g. age, comorbidities, ACSOS , GCS, ICP,     occurrence of complications) as well as some classification schemes used for grading     seriousness of the disease (Hunt and Hess, World Federation of NeuroSurgery).      A tool that is simple, reliable, reproducible, non costly, non invasive, and simple to     perform (including remote methods and without changing planned patient care) would be ideal.      The measurement of the Optic Nerve Sheath Diameter (ONSD,) correlated by MRI and ultrasound     in previous studies, with intra-cranial pressure (ICP: a fundamental prognostic factor for     SAH) could be one of these tools.      This measurement, previously demonstrated using ultrasound, could be carried out at the time     of the patient's initial cerebral scan.      In practice, at admission each patient undergoes a cerebral CT scan much more often than an     ultrasound (faster, less costly, less technical training required).      Two preliminary studies seem to suggest that this measurement of ONSD on CTc is a predictive     factor for morbi-morbidity in patients having serious traumatic skull fractures.The     measurement is reliable, reproducible, non invasive, and non costly, with good sensitivity     and specificity.      Proving that it is also applicable to SAH could be particularly useful.   "
29922|NCT02894021|"     Lymphoceles, or seromas, are the most frequent complication following mastectomy and are     associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as     the presence of a palpable post operative serous accumulation that is bothersome for the     patient and requires a puncture and drainage or even several repeated punctures. The presence     of seromas is therefore associated with discomfort and pain. Seromas could also be     responsible for increased morbidity due to complications such as infection, suture     separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct     treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as     obesity, increased post operative drainage of J1 to J3, and arterial hypertension.      Different measures have demonstrated the benefits of limiting axillary lymphoceles after     dissection : placement of a drain, padding and delay in shoulder mobility.      Studies have shown that axillary padding decreases lymphocele development and shortens the     length of hospital stay. Some studies based on padding of the mastectomy site also have shown     a decrease in post operative seromas; however no study has been done on the usefulness of     padding in the mastectomy site alone because they include both padding and a drain or padding     of the axillary area.      The padding technique the investigators employ is performed at the donor site in breast     reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of     seromas.      In this study, the classic technique will be compared to padding in the mastectomy site with     short drainage (48h).   "
29926|NCT02893969|"     The goal of this study is to investigate when is the best time to resume physical activity     following a head injury. Two treatment plans will be studied; the first treatment plan     consists of gradually reintroducing physical activity in the child's routine, starting 72     hours following the head injury. The second treatment plan involves physical and mental rest     until the child as no more symptoms. Once symptom free, physical activity is gradually     reintroduced in the child's routine.   "
29927|NCT02893956|"     Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery     vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus     screening may generate this hemodynamic response and whether postural support would be able     to modulate it.      Study design      Prospective, single center, randomized study in less than 29 weeks of gestation neonates,     with a post natal age < 48 hours, and requiring invasive mechanical ventilation.      Crossover design with order of echocardiographies determined by computer randomization: in     one group ultrasounds are performed with postural support, than standard conditions, in the     other, ultrasounds are performed in standard conditions than with postural support.      The objective of the study is to assess the ratio of the acceleration time/ejection time of     pulmonary arterial flow.      The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus     shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right     and left ventricular functions using tissue Doppler imaging and speckle-tracking     echocardiography), pain assessment with a clinical scale and heart rate variability analysis.   "
29928|NCT02893943|"     The aim of the study is to evaluate the potential of probiotics on weight management. It is     hypothesized that the consumption of 1 capsule of probiotics daily will modulate the     intestinal gut microbiota thereby reducing body weight and fat compared to those who do not     consume probiotics. In addition, a diet supplemented with probiotics can be expected to be     more beneficial than a diet without probiotic supplementation in impacting biomarkers of     obesity-associated disorders including diabetes, hypertension and CVD.   "
29930|NCT02893917|"     This randomized phase II trial studies how well olaparib with or without cediranib works in     treating patients with castration-resistant prostate cancer that has spread to other places     in the body. Olaparib and cediranib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
29931|NCT02893904|"     A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics     administration. The BIS, which provides a single number resulting from an algorithm     calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and     propofol may have different EEG effects, which might interfere on measured BIS values.      The aim of this prospective randomized study was to compare, in steady state conditions, the     EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both     anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels     of general anesthesia.   "
29932|NCT02893891|"     Literature data clearly demonstrate that treatment of obese patients is very expensive, long     and achieve weight loss may not be permanent, and regardless of whether the treatment     dominated diet therapy, physical activity, or pharmacotherapy. Experience of the last decade     has shown that after surgical interventional treatment of obesity occurs not only long-term     (10 years and over) weight loss of 35-40%, but also an important endocrine changes.      In recent years, it was discovered a number of signaling molecules produced by adipose     tissue, whose physiological significance beyond the general metabolic aspects organism. The     fat is therefore currently understood as an endocrine organ whose hormones modulate the     function of many systems, including the skeleton. These hormones include the adipokines that     modulate metabolism skeleton as at tissue level (Leptin, Adiponectin) and indirectly - by     activation of neurohumoral hypothalamic centers - Leptin.      Studying endocrine interactions between adipose tissue and bone is a highly topical issue.     This mutual communication is a homeostatic feedback system in which adipokines and molecules     secreted by osteoblasts and osteoclasts are the connecting link active axes fat - bone     tissue. However, the mechanisms of this axis remain largely unknown.   "
29933|NCT02893878|"     The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse     drug reaction (ADR) system and the use of routine data to collect adverse events following     vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance     and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify     additional data which may need to be collected in order to appropriately address the     requirement.   "
29934|NCT02893865|"     Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of     coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.      Investigators hypothesise that oxidative stress decrease after 3 months of continuous     positive airway pressure (CPAP) in this specific population.      The results may have major implication in the comprehension of physiopathologic processes     linking OSAS and CAD and in the treatment of OSAS in this specific population.   "
29935|NCT02893852|"     The purpose of this study is to investigate the effects of the Cognitive Orientation to daily     daily Occupational Performance Approach (CO-OP Approach) on activity and participation in     school-aged children with developmental coordination disorder (DCD).   "
29936|NCT02893839|"     Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever     suspicion of allergy were asked to participate in the study. Besides a standard battery of     respiratory allergens, native raw and cooked potato were tested by means of the prick to     prick method, using a metal lancet.   "
29937|NCT02893826|"     Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in     the treatment of aneurysmal subarachnoid hemorrhage.   "
29938|NCT02893813|"     Ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic     watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of     lacrimal point. The objective of the study is to compare two surgical strategies for eyelid     ectropion combined with ectropion of the lacrimal point   "
29940|NCT02893787|"     The main goal of this study is to compare the values of echocardiographic parameters obtained     by Speckle Traking analysis on myocardial function among patients under 18 years treated with     anthracyclines in childhood, with healthy age and sex mached volunteers.   "
29941|NCT02893774|"     Generally, French studies concerned with the quality of life of cancer patients focus on the     period of treatment (up to 2 years post diagnosis). However, studies about quality of life     after cancer are relatively rare (= long-term quality of life, or from 5 years post     diagnosis). These studies mainly concern the most common cancers (breast and prostate).      Or changes in quality of life after treatment could be different depending on the type of     cancer. In addition, there is a significant influence of sociodemographic variables on the     quality of life in remission.      Similarly using remote diagnostics, quality of life questionnaires related to health, must be     reassessed because too often developed for situations in process.      Based on these findings, ELCCA II study proposes to study for five years, the evolution of     the impacts of two types of cancer (breast and melanoma) on quality of life (overall and     related to the subjective health), socioeconomic status, and behavioral and emotional     dimensions (post-traumatic development, coping, anxiety-depression) of those treated.   "
29942|NCT02893761|"     A database of breast cancer patients was established at Institute Bergonié since the 90s , to     assess patients' survival, assess practice, search for prognostic factors.   "
29943|NCT02893748|"     The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep vs     the standard of care Split-dose PEG prep used prior to colonoscopy.   "
29944|NCT02893735|"     The aim of this study was to evaluate the clinical performances of nano-hybrid resin     composite systems used for anterior diastema closure and tooth reshaping at 4 years in     service using FDI Criteria.      Twenty-three patients with diastema problem were enrolled. Nano-hybrid resin composites to be     used on each patient were randomly selected. Thirty-seven teeth (10 patients) were restored     with Filtek-Z550 (3M/ESPE) in combination with Adper™ Single Bond 2 (3M/ESPE) in Group 1;     whereas 39 teeth (13 patients) were restored with Charisma-Diamond (Heraeus Kulzer) in     combination with Gluma2 Bond (Heraeus Kulzer) in Group 2, by two operators. Esthetic,     functional and biological properties of the restorations were evaluated at baseline, 1-4     years using FDI Criteria establishing a score-range of 1-5. The data were evaluated using the     Fisher's Chi-Square (p=0.05).   "
29945|NCT02893722|"     This study intends to carry out a prospective, randomized, double blind and controlled study     to compare the influence of Atosiban and placebo on uterine contraction frequency,     endometrial blood flow perfusion, oxytocin and serum concentration of PGF2α, embryo     implantation rate and clinical pregnancy rate on the RIF population after fresh embryo     transfer, so as to further clarify the curative effect of Atosiban in the treatment of RIF     and provide evidence-based basis for Atosiban for application in RIF population.   "
29946|NCT02893709|"     The objectives of this study are to examine the effects of ethnicity, gender, and proton pump     inhibitor (PPI, omeprazole), on the human gut microbiome. The investigators hypothesize that     PPI therapy might perturb microbial communities and alter the gut microbiome. Young, healthy     subjects of Chinese, Malay and Indian ancestry, were enrolled. They were required to provide     a baseline stool sample (Day 1) and were then given a course of omeprazole at therapeutic     dose (20 mg daily) for a duration of 7 days. Stool samples were collected again on Day 7 and     Day 14 (one week after stopping omeprazole). The DNA samples were subjected to 16S ribosomal     ribonucleic acid (rRNA) sequencing.   "
29947|NCT02893696|"     After injection of the spinal anesthetic drug, women will be allowed to lie down immediately     (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension     and fetal umbilical cord blood pH will be recorded.   "
29949|NCT02893670|"     Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel     diseases (IBD) to adult care is necessary in order to secure continues clinical management     and to prevent possible deleterious clinical and psychosocial implications. In recent years     there is an emphasis on successful transition, however, there are no standardized models or     consensus guidelines incorporating both clinical and psychosocial aspects of transition.     Objectives: To examine the effect a comprehensive clinical and psychosocial transition     package on clinical management and patients outcomes in adolescents with IBD. Design: A     prospective, trans-sectional study. Setting: The Schneider Children's Medical Center and the     Rabin Medical Center. Participants: Children 17 year to 18 years who are diagnosed with IBD     and are planned to initiate transition process to adult care. Main outcome measures: Change     in clinical management as a result of tailored re-evaluation as a part of tailored transition     package. Secondary outcome measures: a. The effect of a tailored transition package on     patients' self-efficacy perception and readiness for transition. b. The effect of a tailored     transition package on patient's outcomes (disease activity, flares, hospitalizations) during     the first year following transition.   "
29950|NCT02893657|"     The aim of the present study is the evaluation of the occurrence and effect of hepatic     dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in     liver haemodynamics in the early postoperative period.   "
29951|NCT02893644|"     Prospective study aiming to measure central ablation depth during excimer laser surgery in     myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP,     before and after laser ablation. This measurement will be compared with pre and 1 month     postoperative topography differential pachymetric measurements.   "
29952|NCT02893631|"     Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery     occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis     induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of     these effects are unknown. Thus management of antithrombotics and hemostasis during     thrombectomy and surgery is an issue.      Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis,     coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to     evaluate the time required for the normalization of these disorders.      Methods : Observational monocentric study including rtPA-treated patients requiring     endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA     administration to assess of fibrinolysis, coagulation and platelet functions with point of     care devices and specific laboratory tests. Record of clinical and biological data.   "
29953|NCT02893618|"     Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR,     1 of which is administered both with and without food.   "
29954|NCT02893605|"     This is a case-control study performed on a biological collection. The polymorphisms present     on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis     (sporadic type) DNA samples and 400 control DNA samples.   "
29955|NCT02893592|"     The photorefractive keratectomy was the first correction mode refractive laser. It's a     photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of     epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a     lot of interests: facility and speed of procedure as well as suppression of human variable.     Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non     inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive efficiency   "
29956|NCT02893579|"     This is a single center, randomized controlled trial which will include women with ischemic     heart disease to receive either a self-directed stress reduction program delivered through a     smart-phone application or activity tracking only for the first month (early SR     intervention and delayed SR intervention, respectively). Patients will be monitored for 1     month for application use and step counts via telephone or email interview and/or collection     of screen-captured data. Baseline questionnaires will be repeated at the end of one month to     assess for all primary and secondary measures, at which time the control group (activity     tracking only) will be introduced to the intervention program. The early SR intervention     group will not receive a new intervention but will be encouraged to continue using the app.     Data will be collected for an additional 2 months with all participants in both groups. After     the three-month study period, the study will close with the collection of final questionnaire     data.   "
29969|NCT02893410|"     Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential     thrombocythemia completed an unique paper questionnaire in order to describe their     observance, the side effects and their own appreciation of the taken drug.   "
29970|NCT02893397|"     The goal of this clinical research study is to learn if regular exercise is possible for     children and young adults with bone cancer who are having chemotherapy.   "
30491|NCT02886611|"     The study aims at searching for a genotype-phenotype correlation in patients with a genetic     pathology of the ocular surface, in order to identify genetic abnormalities associated with     the most severe clinical situations.   "
29957|NCT02893566|"     This is an eight-month research project using one group pretest-midst-posttest design. This     study is based on self-efficacy and self-regulation of Social Cognitive Theory. The     investigators will recruit 50 university students with a body mass index of 24 kg/m2 or above     at one university campus. Participation is completely voluntary. After pretesting, a 12-week     Mi Band Step Challenge will be launched immediately. Participants will be assessed with the     validated instruments of International Physical Activity Questionnaire (IPAQ)-Taiwan     short-form, Sedentary Behavior Questionnaire (SBQ), self-efficacy and self-regulation     questionnaires. Mi Band activity trackers will be used to monitor step counts. An ioi 353     body composition analyzer will be used to assess body composition. Data will be analyzed     using generalized estimating equation (GEE).      The expected outcomes of this study include: (1) Mi Band Step Challenge will be developed     based on the theory, which is expected to be effective. If this is true, the intervention can     be packaged and applied at different types of colleges and universities with overweight     students. (2) Mi Band Step Challenge has the potential to be used for the reference of the     healthy weight - physical activity, which is embedded in the School Health Promotion Program     executed by the Ministry of Education. (3) The result of this study can serve as an example     for the promotion of evidence-based health care.   "
29958|NCT02893553|"     Dysregulation of blood pressure (BP), secondary to decentralized autonomic nervous system     (ANS) control of the cardiovascular system, often results in chronic hypotension and     orthostatic hypotension (OH) in persons with spinal cord injury (SCI), particularly in those     with high cord lesions (i.e., above T6). While most hypotensive individuals with chronic SCI     remain asymptomatic and do not complain of symptoms associated with cerebral hypoperfusion,     evidence of reduced resting cerebral blood flow (CBF) has been reported in association with     low systemic BP in the SCI and non-SCI populations. Reduced CBF in hypotensive individuals     may lead to cognitive dysfunction, and we reported significantly impaired memory and     marginally impaired attention processing in hypotensive individuals with SCI compared to a     normotensive SCI cohort. Furthermore, we found that CBF was not increased during cognitive     testing in individuals with SCI, which may contribute to impaired cognitive function compared     to non-SCI controls. Although asymptomatic hypotension may have an adverse impact on     cognitive function and quality of quality of life (QOL) clinical management of this condition     is extremely low. In fact, we reported that while nearly 40% of Veterans with SCI were     hypotensive, less than 1% carried the diagnosis of hypotension or were prescribed an     anti-hypotensive medication. The discrepancy between incidence and treatment of asymptomatic     hypotension in the SCI population may relate to a paucity of treatment options which are     supported by rigorous clinical trials documenting safe and effective use of anti-hypotensive     therapy on BP, CBF and cognitive function. We hypothesize these study medications may     increase systolic blood pressure to the normal range and improve cerebral blood flow     velocity. Results and conclusions will not be removed from the record.   "
29959|NCT02893540|"     The optimum regimen of maintenance treatment after first-line chemotherapy in patients with     metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the     efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy versus     conventional chemotherapy.   "
29960|NCT02893527|"     Evaluate and compare the return to work rate at 12 months   "
29961|NCT02893514|"     This study will develop a clinical decision support tool that assists primary care providers     in carrying out substance use interventions, and then compare (in Phase 2) two clinical     scenarios, screening only (SO) vs. SUSIT, (on dose of substance use brief intervention     received) and changes in drug use at 3 and 6 months, among primary care patients.     Investigators will develop the Clinical Decision Support (CDS) component and then test the     full SUSIT approach, using mixed methods to assess its acceptability and adoption, and     gathering preliminary data on its efficacy for reducing unhealthy drug use. CDS development     is concurrent with the SO phase to avoid losing valuable time, but will be conducted at a     secondary study site to avoid contaminating the SO condition.   "
29962|NCT02893501|"     The objective of this study is to evaluate the microbiome composition of infant's (9-12     month) skin experiencing diaper rash in order to determine if the onset and severity of     erythema associated with diaper rash is influenced by the type of bacteria colonizing the     skin.   "
29963|NCT02893488|"     This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment     groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and     relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of TRIUMEQ™     ([abacavir, ABC]/[dolutegravir, DTG]/[lamivudine, 3TC]) when dispersed and consumed under     four different dosing conditions in comparison to an oral dose of TIVICAY™ (DTG) + EPZICOM™     (ABC/3TC) non-dispersible tablets administered in the fasted state. Approximately 20 subjects     will be randomized, each to one of 5 treatment groups. The total duration of participation of     a subject in this study will be approximately 10-11 weeks. It will include a screening visit     within 30 days prior to the first dose of study drug, five treatment periods each with a     single dose of study drug per treatment period and a follow up visit within 7 10 days after     the last dose. There will also be a washout of at least 7 days between doses in each     treatment period. TRIUMEQ, EPZICOM, and TIVICAY are trademarks of the GlaxoSmithKline group     of companies.   "
29964|NCT02893475|"     Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal     disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive     transplantation, before beginning dialysis.      The main objective of this study will be to investigate quality of life and societal     participation in a population of LD kidney transplant recipients comparing preemptive LD     transplantation versus non-preemptive transplantation (performed after a period of dialysis).   "
29965|NCT02893462|"     The aim of this study is the establishment of a warehouse physiological data and biomedical     signal in intensive care adult patients in acute situations from particular records from the     Philips Intellivue MP70 monitor.   "
29966|NCT02893449|"     Main objective:      To assess the impact of a structured program of preoperative cognitive remediation on     postoperative social adaptation in patients suffering from Parkinson's disease profiting from     bilateral subthalamic nucleus stimulation.      Secondary objectives:      To assess in the same patients the impact of structured program of preoperative cognitive     remediation on quality of life, mood, anxiety, apathy and psychologic, social and     professional functioning depending on psychiatric symptomatology after intervention.   "
29967|NCT02893436|"     The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment     when 2 responses to double burst stimulation are visually identical and this for 95% of     patients.   "
29968|NCT02893423|"     With this research the investigators hope to determine the lowest dose of ropivacaine used in     transversus abdominis plane (TAP) blocks that can effectively treat pain in women after     cesarean section (c-section).   "
29971|NCT02893384|"     Pain following mastectomy surgery for breast cancer can be significant. Poorly managed pain     in the immediate time-period following surgery can potentially lead to long-term (chronic)     pain conditions. There is still a need to find the safest, least invasive, and most effective     method to manage this pain. The investigators believe that a new technique of injecting local     anesthesia (freezing) in to specific areas at the end of mastectomy surgery may be a very     important step to managing pain after breast surgery. The investigators would like to begin     by performing a pilot study, meaning the investigators will perform the technique in patients     and compare what their pain outcomes are to patients who have not had the technique.   "
29972|NCT02893371|"     The objective of this retrospective observational study is to compare commonly prescribed     bipolar disorder medications for their impact on: (1) all-cause mortality; (2)     hospitalization; (3) mood episodes; (4) suicide attempts and self-harm; and (5) risk of     drug-induced adverse effects such as kidney disease/failure and metabolic syndrome. In     addition, the investigators will examine heterogeneity of treatment effect by co-morbidity     within pediatric, adult, and elderly sub-populations.   "
29973|NCT02893358|"     The primary purpose of the study is to estimate the target organ protection after 12 months     of antihypertensive treatment in masked hypertension patients with at least one kind of     target organ damage (left ventricular hypertrophy, large arterial stiffness and     microalbuminuria). Improvement was defined as the relevant parameter back to normal or     declined at least 20%.      The secondary objectives include: blood pressure lowering effect, target organ damage     parameters improvement, and the incidence rate of all cause death and cardiovascular events     (stroke and myocardia infraction).   "
29974|NCT02893345|"     People who sustain moderate to severe traumatic brain injury (TBI) have an increased risk for     unintentional injury and harm when resuming day to day activities in the home and community.     People who sustain brain injuries primarily want to independently do the activities they     enjoy while families primarily focus on avoiding injury or other harm events. Safe@Home is an     injury prevention education and activity training program. Participants who have sustained a     moderate or severe TBI receive a personalized strengths and safety risk assessment, tailored     injury prevention education, and in-home training with a transition coach on self-selected     activities. This study will evaluate whether the Safe@Home program reduces injuries and harm     and increases clients' independence in their everyday activities in the home and community     compared to a usual care control group.   "
29975|NCT02893332|"     To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than     or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS)     compared to TKI alone.   "
30000|NCT02893007|"     Family interventions have been emphasized in the treatment of BPD and have benefits for     patients' symptoms and health; however, the effects of family interventions on family     function and caregivers' health-related outcomes have not been well investigated. This     randomized controlled trial with 47 hospitalized patient-with-BPD/family-caregiver dyads at a     medical center in northern Taiwan compared the effects of a brief family-centered care (BFCC)     program with treatment-as-usual (TAU). The findings support both the feasibility of using the     BFCC program for inpatients and its specific benefits for family function. An intensive     family intervention during hospitalization has been suggested in psychiatric practice to     support patients with BPD and family caregivers.   "
29976|NCT02893319|"     Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later     in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with     early rapid growth, and include high maternal BMI prior to pregnancy and excessive     gestational weight gain. This research focuses on aspects of early feeding as potentially     modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized     to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks     postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads     are also included. The hypothesis is that differences in feeding practices will be associated     with differences in growth and that infants randomized to be fed from smaller bottles will     grow more slowly that those randomized to larger bottles. Growth patterns of formula fed     infants will also be compared to those of exclusively breastfed infants.   "
29977|NCT02893306|"     The purpose of this study is to evaluate whether the administration of multipotent stromal     cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.   "
29978|NCT02893293|"     The goal of the project is to evaluate osteonecrosis before and after decompression surgery     with ferumoxytol-enhanced MRI.   "
29979|NCT02893280|"     ACSSLAP is the first island wide audit project in Sri Lanka on ACS.   "
29980|NCT02893267|"     Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke     survivors. HSP is associated with poor rehabilitation outcomes, including interference with     activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for     HSP have been proposed, most do not result in long-term relief of pain.      The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for     the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular     electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic     review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only     treatment to provide long-term relief of pain for those with HSP. However, physical therapy     (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for     HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical     community, the superiority of PNS to a course of PT must be demonstrated. The investigators     completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants experienced     successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively. Thus,     the primary objective of this 2-site RCT is to confirm the findings of this preliminary pilot     RCT. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice,     may have a synergistic therapeutic effect. Thus, the second objective of this RCT is to     determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief     than PNS alone or PT alone. Mechanisms also will be explored.   "
29981|NCT02893254|"     Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with     ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to     one or more nonsteroidal anti-inflammatory drugs (NSAIDs)   "
29982|NCT02893241|"     This is a national, multicentre, prospective, open, two-arm, non-interventional study with     hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine     after occurrence of perioperative hypotension, wherein the patients are assigned to a     treatment arm based on the department.   "
29983|NCT02893228|"     Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an     incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local     anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline     in this anatomical location prior to performing an interscalene block the incidence of     phrenic palsy will be reduced.   "
29984|NCT02893215|"     The primary aim of the present study is to screen high-risk type 2 diabetes patients and     heart failure patients without any history of atrial fibrillation (AF), ongoing oral     anticoagulation (OAC) treatment, implanted device or recent stroke/Transient Ischemic Attack     (TIA), for silent AF.      Moreover, we aim to establish the prevalence of two or more risk factors for stroke in     patients with heart failure and diabetes mellitus type 2 (DM2) with the aim of assessing the     feasibility for this group to undergo AF screening.      Overall, the aim of the study is to prevent stroke in high-risk patients groups through     identification of silent (asymptomatic) atrial fibrillation.   "
29985|NCT02893202|"     The purpose of the research project was to assess changes in Posttraumatic stress disorder     [PTSD] symptoms, quality of life and participation of combat veteran who participate in     equine assisted activities [EAA]. The study used a mixed-methods, waitlist-controlled,     repeated measures trial of a standardized 8-week therapeutic riding intervention for combat     veterans with PTSD. Behavioral changes were assessed four times during the study. Veterans     meeting inclusion criteria were selected to participate in either the intervention group or     the control/waitlist group.   "
29986|NCT02893189|"     Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical     standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels     planned.      Patients will be followed up regularly during the interventional phase of the study until 12     months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually     for years 2 and 3.   "
29987|NCT02893176|"     Potential therapy with MACITENTAN in the treatment of Chronic Lung Allograft Dysfunction     (CLAD) after Lung Transplantation. Pilot Study, Double-blind, ADD-ON Therapy with     MACITENTAN to usual standard of care immunosuppressive therapies after lung transplantation     for established BOS Stages I or II versus a matched control group who receive usual     standard of care immunosuppressive therapies alone, results in a decrease in the Primary     Endpoint: rate of decline in Forced Expiratory Volume-1 sec (FEV1) versus time while     Secondary Endpoints including: differences in Six minute walk distance (6MWD), BORG Score,     corrected single-breath diffusing capacity (DCO corrected) at time intervals of 1, 3, 6     months on therapy. Specific biomarkers for BOS, including inflammatory chemokines, which are     routinely collected in the context of post-transplant surveillance will be analyzed.     Chemokines which our group has previously described in the pathogenesis of the continuum of     acute-to-chronic lung allograft rejection, have included both C-C (CCL2, CCL5) and CXC     (CXCL9, CXCL10, CXCL11) chemokines as determined in bronchial-alveolar lavage (BAL).   "
29989|NCT02893150|"     Mindfulness has been applied in the United States and Europe to improve both physical and     psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its     lack, may also have particular relevance to obesity and eating disorders, reducing the     episodes of binge eating, which are partly responsible for weight regain for many people,     and improving the eating behavior in order to promote awareness of emotional states which     distort the physiological signals generated by the process. The hypothesis is that     Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious     eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a     sustainable fashion, improve biochemical, psychometric and anthropometric parameters in     primary care patients with overweight.   "
29990|NCT02893137|"     The present study proposes a new and potentially superior clinical approach to Optune™     therapy of selected glioblastoma patients. The approach is based on combining TTFields with     targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr     holes, designed for the individual patient. Pre-clinical modeling results suggest that such     procedures may enhance the induced electrical field strength by up to ~100% and thereby     potentially improve the clinical outcome of treated patients to a significant extent.      The study is an open label phase 1 clinical pilot experiment designed to investigate     feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of     glioblastoma will be included in the trial. All patients will receive TTFields therapy with     targeted craniotomy and best physician's choice chemotherapy.   "
29991|NCT02893124|"     HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of     drug resistance or suboptimal/partial virological response were enrolled. After giving     informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly     subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80     micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with     weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80     micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).   "
29992|NCT02893111|"     Neuromyelitis Optica Spectrum Disorders (NMOSD) is characterized by the pathogenic anti-AQP4     antibody, which can be produced by specific plasma cells. The patients who are not responsive     to rituximab treatment may be due to the presence of short-lived and long-lived plasma cells.     Previous studies confirmed that the proteasome inhibitor bortezomib (Velcade®, approved for     therapy of multiple myeloma) eliminated both plasmablasts and plasma cells by activation of     the terminal unfolded protein response. Treatment with bortezomib may help deplete plasma     cells producing auto-antibodies. Therefore, the rationale for using bortezomib in NMOSD is in     that bortezomib may help eliminate autoreactive plasma cells and reduce anti-AQP4 antibodies     titers. It is noted that bortezomib may protect astrocytes from NFκB-dependent inflammatory     damage in early events in NMOSD pathogenesis.      The purpose of this study is to determine if the drug bortezomib contributes to reduce the     average relapsing rates (ARRs) and alleviate neurological disability in NMOSD patients.   "
29993|NCT02893098|"     A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical     Trial   "
29994|NCT02893085|"     The differential diagnosis between benign and malignant bile duct strictures is a difficult     and demanding task for clinicians. Clinical, biochemical, and radiological characteristics of     malignant biliary strictures are non-specific and tissue diagnosis is difficult to obtain     preoperatively. For this reason, there is a need for the development of new diagnostic     modalities. Of particular interest is the quest of tumor markers secreted or shed in bile by     tumor cells developing in the biliary tract.      In addition, patient's tumor molecular profile is the basis for selecting personalized     therapy. Cholangiocarcinomas are characterized by a large genetic heterogeneity. The most     frequent mutations are TP53, KRAS, BRAF, EGFR, MET, NRAS, PIK3CA, ERBB2, SMAD4, FBXW7,     ARID1A, PBRM1, BAP1 et IDH1/2. In the case of pancreatic cancers, the most frequent are KRAS     mutation detected in 90 % of the patients and CDKN2A, SMAD4, TGFBR1, TGFBR2, ATM, BRCA2,     MLL2, MLL3, KDM6A, ARID1A, ARID1B, SMARC1, GNAS and RNF43 mutations.      It is well established that KRAS and P53 mutations can be detected in bile samples from     patients with biliary strictures related to cholangiocarcinoma and cancer of the head of the     pancreas. The main objective is to determine if bile sample analysis from patients with     malignant biliary stricture may allow to identify tumor mutation profile and determine tumor     genotype. A secondary objective is to evaluate the diagnostic value of Vascular Endothelial     Growth Factor (VEGF) and metallo-proteinases (MMPs) levels in bile samples.      Tumor genotyping will be performed in bile samples (supernatant and cell pellet) and tumor     tissues in a series of 10 patients surgically treated for malignant biliary stricture related     to cholangiocarcinoma or cancer of the head of the pancreas. The biochemical markers, VEGF     and MMPs, will be assessed in bile samples obtained during endoscopic retrograde     cholangiopancreatography in 50 patients with malignant biliary stricture and 50 patients     treated for benign biliary diseases.   "
29995|NCT02893072|"     Gestational diabetes mellitus (GDM) is one of the most frequent complications of pregnancy,     that affect between 1 to 14% of population around the world. The overall purpose of this     study is to determine the efficacy of individualized medical nutrition therapy (MNT)     intervention to reduce and control the development of GDM.   "
29996|NCT02893059|"     The main objective of this study is to estimate the reporting bias of patients in terms of     prescripted drug and care consumption by comparing data collected in a patient diary and     database of health insurance .   "
29997|NCT02893046|"     The main objective of this research is to evaluate a care pathway adapted to different     category populations at risk of being infected with the hepatitis C virus in order to improve     both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick     and effective access to diagnosis and treatment of HCV by strengthening the city hospital     networks, access to early consultations and coordination of medical social actors.   "
29998|NCT02893033|"     The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to     2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS     conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional     outcome swallowing scale (3 scales). 3. MEP measurements   "
29999|NCT02893020|"     Recent studies have highlighted a high incidence of burnout among surgeons. The aim of this     study is in particular to investigate if this is the consequence of performing surgery (i.e.     invasive procedures) or whether it is related to the cultural background of surgeons.   "
30091|NCT02891824|"     This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess     the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab     administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial     ovarian cancer (including patients with primary peritoneal and / or fallopian tube     adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).   "
30001|NCT02892994|"     This study will compare ultrasound 0.4 W/cm^2 and 100% duty cycle versus no ultrasound     (placebo) for bilateral masseter myalgia in up to 38 adult women. The dose will be applied     for 5 minutes on each side. Both the dose and the starting side will be randomized. Both the     subject and ultrasound operator will be blind to the dose. The outcome measures will be     pressure pain threshold on both masseter muscles and both temporalis muscles, self reported     pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles, and     intraoral temperature. These outcome measures will be taken before and after each dose, so     three times per subject.   "
30002|NCT02892981|"     Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion     mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension     patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic     and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two     components, alveolar and dead space ventilation.   "
30003|NCT02892968|"     Hip fractures are common, costly and affect older people - Canadians spend 1 billion dollars     to treat hip fractures each year. Unfortunately, as many as two-thirds of hip fracture cases     suffer a complication known as delirium, or acute confusion. Patients with delirium may     become frightened and agitated. This in turn leads to other serious problems. Having delirium     doubles the chances of dying or can increase the need for admission into a nursing home.     People with delirium spend an extra week in hospital on average.      Using ultrasound to locate and 'freeze' or block specific nerves can stop hip fracture pain     almost immediately, and use of this technique is known to reduce delirium when administered     by Anaesthetists to patients at the time of their hip operation. Unfortunately, patients with     hip fractures commonly wait hours or even days in the Emergency Department (ED) prior to     their operation. Currently, these patients are given narcotic pain killers like morphine to     dull their pain, as most ED physicians have not been trained in using this 'freezing'     technique and Anaesthetists are rarely able to leave the operating room to administer     freezing to patient in the ED.      The EDU-RAPID study will test whether training ED physicians on how to use the nerve freezing     technique will reduce the number of patients who develop delirium after a hip fracture. To     study this, ED physicians will be trained at 6 hospitals in small groups every 6 weeks over     18 months. The study will look at how patients who are treated by ED physician who has been     trained compare to patients treated by a ED physician who has not yet been trained. Also, the     study will see if the training motivates ED physicians to use the block regularly.      If correct, this study could significantly improve the comfort, quality of life, and     independence of patients who suffer a hip fracture. In addition, if the study shows a     reduction in delirium rates, this could represent a significant cost reduction to the health     care system.   "
30004|NCT02892955|"     The objective of the study is to continue to evaluate safety and clinical performance of the     HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following     completion of enrollment in the the MOMENTUM 3 IDE Study.   "
30005|NCT02892942|"     To overcome unsuitable effects of controlled ovarian hyperstimulation (COH )while maintaining     large oocyte availability, investigators elaborated an innovative protocol (NATural Ovarian     Stimulation) that dissociates E2 production from multiple follicle development.      The purpose of this prospective, randomized trial is to demonstrate that, in a good prognosis     IVF-ET population, the physiological E2 environment resulting from NATOS significantly     improves IVF-ET outcome when compared to the conventional GnRH antagonist protocol.   "
30006|NCT02892929|"     This randomized clinical trial was designed to test the effectiveness of Motivational     Interviewing in lowering blood pressure during six months follow-up.   "
30024|NCT02892695|"     The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients     who are going to receive stem cell transplantation but without available treatment to achieve     complete remission prior to the transplant.   "
30007|NCT02892916|"     Postoperative delirium is a frequent complication of major surgery and affects 10% to 70% of     surgical patients > 60 years. Delirium is associated with increased morbidity and mortality,     prolonged recovery, functional and cognitive dysfunction with nursing home or long-term care     facility placement. The acute deterioration in cognition and psychomotor agitation frequently     seen with delirium is often distressing for both patients and their relatives. The     pathophysiology and causal relationship between delirium and persistent postoperative     cognitive dysfunction remain incompletely understood. Identified clinical risk factors for     both include advanced age, type of surgery, preexisting cognitive impairment, and drug     addiction. The inflammatory response triggered by surgical trauma and pain may contribute to     the development of delirium and cognitive impairment after surgery.      Ketamine, a N-methyl-D-aspartic acid receptor antagonist, is commonly used in anaesthesia and     postoperative analgesia. By reducing both pain and glutamate excitotoxic effects on neuronal     and microglial brain cells, it contributes to tone down the neuroinflammatory process     associated with surgery. A recent body of evidence has shown that ketamine reduces the     depressive-like behavior induced by inflammatory or stress-induced stimuli in mice. Ketamine     was also found to reduce by 28% the absolute risk of postoperative delirium and levels of     inflammatory biomarkers in cardiac surgical patients.      Orthopaedic surgery is a high-risk situation for developing postoperative delirium. In     patients undergoing total hip or knee replacement, the prevalence (incidence, respectively)     of delirium is 17% (12-51%, respectively) and it is associated with a 6-fold increase     increased risk of developing dementia and cognitive dysfunction after surgery. Hundred     thousands of patients > 60 years undergo elective orthopaedic procedures per year around the     world. The purpose of the study is to assess the superiority of ketamine at subanaesthetic     dose versus placebo to reduce the incidence of postoperative delirium in patients aged ≥ 60     years undergoing elective orthopaedic surgery under general anaesthesia.   "
30009|NCT02892890|"     Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired neuropathy     characterized by an inflammatory multifocal segmental demyelination. Due to the clinical     heterogeneity of this condition and the lack of specific marker that can reliably identify     all patients, the diagnosis of CIDP remains difficult. Similarly, there are no clear factors     predicting the evolution or the prognosis of the disease. Current treatments are the     intravenous immunoglobulin (IVIg), corticoids and plasma exchange; IVIg therapy being the     most commonly used. Responses of the patients to the treatments are variable. Thus, it is     necessary to identify predictive markers of the therapeutic response of CIDP patients treated     by IVIg.      Several potential biomarkers have been proposed recently, but none of them has yet been     validated as a predictive criterion for therapeutic response. It is therefore necessary to     continue to investigate several biological parameters to identify a reliable biological     marker.      In electromyography, the Motor Unit Number Index (MUNIX) technique allows measuring the     axonal loss by a precise count of functional motor units. This method, more sensitive than     the measure of the Compound Muscle Action Potential (CMAP), is rarely used in CIDP. MUNIX     might be a good tool to better characterize the patients and to follow the course of CIDP. It     also might be a new sensitive and reliable marker predictive of the therapeutic response.      Magnetic resonance Imaging (MRI) is increasingly used for the assessment of neuromuscular     diseases. A recent study on CIDP patients reported a significant decrease of the muscle     Magnetisation Transfer Ratio (MTR) compared to healthy subjects, correlated to clinical     parameters. The use of advances MRI techniques could allow characterizing the structure and     composition of muscle and nerve tissues of CIDP patients. It could also be a mean for     identifying potential new markers, largely unexplored until now, that might be sensitive to     disease course and/or IVIg response.      The objective of this study is to identify predictive markers of the treatment response of     CIDP patients receiving IVIg.      This is a prospective observational exploratory study of a cohort of 30 CIDP patients treated     with IVIg and followed-up during one year.   "
30010|NCT02892877|"     The French Gestational Trophoblastic Disease (GTD) centre has been set up and active by     registering, monitoring and treating women with GTD since november 1999. The aim is to     improve the management of trophoblastic disease in France.      About 850 new cases are registered each year and 140 women treated, mostly with chemotherapy     and surgery.      The center works as follow, based on a multidisciplinary approach. The policy is that patient     remains followed by her local physician, but can be seen and treated in the Center at demand     and that the registry is done on a voluntary basis.      Each administrative french area has a local expert team (oncologist and gynaecologist) who is     able to look after the patients with the help of the national reference center physicians     based in Lyon.        -  Once a doctor discovers a molar pregnancy, he contacts the center, with the agreement of          his patient, for an opinion, an advice or simply to report the case.        -  The center sends to the doctor the informed consent form to be signed by the patient, a          registering form and information about pathology for patient and physician, and first          guidelines based on initial pathology report.      The patient remains followed by her gynecologist, who stays her first interlocutor throughout     the whole process and she goes to her local laboratory for hCG monitoring;        -  A letter is sent to the initial pathology laboratory that originally carried the          diagnosis of molar pregnancy to require slide sending to the pathologist referral center          (9 experts with a specific pathologist national network) that centrally review initial          diagnosis.        -  In the mean time, the data manager collects weekly hCG values to establish a follow-up          chart. The physician is regularly informed by mail of the hCG evolution.        -  The local physician is contacted in case of modification of the diagnosis by the          pathologist expert. The center informs him about length and monitoring methodology.        -  Emails or letters are sent at each step of the management (at inclusion, at hCG          negativation, and at the end of hCG follow-up).        -  In case of abnormal hCG evolution (raise, plateauing or positivity at 6 months,) or if a          neoplasia is anatomopathologically diagnosed (choriocarcinoma, PSTT or ETT), physician          is immediately contacted by phone or email by referent gynaecologist. A complete work up          including pelvic US with Doppler, pelvic MRI, thoraco-abdominal CT-scan with chest          radiography if pulmonary nodules are present and brain MRI, is planned to determine the          adequate treatment.      Very briefly, based on imaging results, FIGO stade and score are calculated to determine the     risk. In case of low-risk, a monochemotherapy is settled, while a polychemotherapy is started     in case of high-risk disease.      The investigators have developped specific expertise at key levels of diagnosis, management,     follow-up, fertility preservation and treatment.      Assignments :        -  Registration and monitoring post diagnosis of complete or partial molar pregnancy,          choriocarcinoma,PSTT, ETT, atypical placental site nodules        -  Histopathological analysis and genetics services        -  Measurement of human chorionic gonadotrophin (hCG) isoforms        -  Complex gynaecological surgery   "
30011|NCT02892864|"     Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear     lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is     a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial     functions and the ability to convey emotional facial information are seriously affected by     facial palsy, thereby reducing patient's quality of life. The PFP can have several     repercussions on the functional, aesthetic, social, occupational and psychological levels.     Evolution and prognosis depend not only on its etiology and gravity, but also on the     precocity and the quality of the medical and paramedical care. It is essential to assess     functional and psychological issues before beginning an adapted global therapeutic care. If     these depressive symptoms can be explained by multiple factors, the inability to smile would     be one of the triggering factors of depression. The facial feedback hypothesis could be one     of many explications because smiling induces a positive emotional state and a feeling of     well-being. In PFP, patients must cope with their difficulties to smile. Their facial     behaviour affected their own emotional experiences.      The main purpose of the present study is to determine if virtual rehabilitation program is     relevant compared to standard therapy. The second aim is to characterize the efficiency by     analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A secondary     objective will be to decrease the functional and social repercussions of the facial paralysis     with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation     program will be implemented in an interactive platform.      To this end, a parallel randomized controlled trial (RCT) of the two groups will be     conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment     in which active participation of the patient is necessary so only the assessment will be     blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic     devices, objective and subjective evaluation with pragmatic fields such as communication,     emotion and quality of life. The severity of patient's facial paralysis is appraised by the     House and Brackmann scale. This global assessment will be conducted before the beginning of     the therapy and every 3 months during 18 months.      The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a     baseline assessment. Simple randomization will be used in order to establish both therapeutic     groups with 45 patients in each group.      Group A: Patients taken care in consultation within the ENT service which provides     oro-myo-functional classical rehabilitation.      Group B: Patients taken care in external consultation who receive oro-myo-functional     rehabilitation through a virtual rehabilitation program targeted at the smile, in their place     of living in virtual conditions.      The patients must have been diagnosed with unilateral peripheral facial palsy, according to     House and Brackmann international classification.      Inclusion time : 18 months      Between-two-groups analysis will be conducted in order to compare a targeted and intensive     implementation-intention rehabilitation such as virtual rehabilitation program to standard     therapy. This virtual therapy will consist in repeating mentally movement desired, so that it     will be more spontaneously executed in the every-day-life situation.   "
30092|NCT02891811|"     This is a randomized, 2-arm phase II, multi-center study to evaluate the overall response     rate in newly diagnosed, transplant ineligible patients receiving 9 cycles induction therapy     with either KTd or KRd followed by randomization to either carfilzomib maintenance treatment     for 12 months or to observation only. Maintenance is given for 12 cycles or progression of     disease, whatever occurs first.   "
30012|NCT02892851|"     Cocaine addiction is a chronic condition with severe cardiac, neurologic, psychiatric and     social complications. Cocaine is the second most consumed illicit drug in France. Its     prevalence has been multiplied by 3 between 2000 and 2008, and is still on the rise. Craving,     the compulsive need to consume, is a key feature of cocaine addiction. It is also predictive     of treatment efficacy. However, there is no validated treatment for severe cocaine dependence     yet. Response to current psychological and medical treatment is poor, with 73% relapse after     3 months. Patients with severe cocaine addiction are thus in a therapeutic deadlock.      To address these unmet medical needs, the investigators designed a pilot study (n=2) to     evaluate the safety and the efficacy of the deep brain stimulation of the subthalamic nuclei     (STN-DBS) in severe cocaine addiction with at least one cardiac, neurologic or psychiatric     complication. Indeed, compulsivity is a critical component of craving, and severe     treatment-resistant obsessive compulsive disorder (OCD) are already successfully treated     using STN-DBS. Moreover, animal studies recently demonstrated a therapeutic effect of STN-DBS     in rats addicted to cocaine. Together, these two lines of research suggest a therapeutic     effect of STN-DBS in cocaine addiction mediated by an anti-obsessive mechanism on craving.   "
30013|NCT02892838|"     Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to     relieve pain, restore function and correct deformity. It is a very common surgical procedure     with figures showing more than 500'000 arthroplasties performed annually worldwide. Total     knee arthroplasty is considered one of the most successful types of joint reconstruction in     that surgical results usually meet and even exceed expectations. Much of the current     literature focuses on the issues relating to implant wear as a potential failure mode for     artificial knee implants. It has been suggested that knee with mobile or rotating bearing     options, such as the comparative device proposed for this clinical investigation, may survive     longer than fixed bearing knee designs because of the greater contact surface area possible     with more congruent components with unconstrained, mobile component design.   "
30014|NCT02892825|"     The purpose of the study is to assess the effect of music therapy on anxiety and hypertension     during cataract surgery procedures performed under topical anaesthesia.   "
30015|NCT02892812|"     The purpose of this study is to evaluate the safety and immunogenicity of LBVE013     (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014     (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.   "
30025|NCT02892682|"     Previous studies reported infraclinical modifications of the homeostasis in chronic     urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to     compare groups with isolated wheals, isolated angioedema, combination of both and hereditary     angioedema in terms of coagulation pathways.   "
30026|NCT02892669|"     This study is designed to evaluate the predictive value of heart rate variability on medial     outcome in patients admitted to the intensive care department   "
30027|NCT02892656|"     The purpose of this study is to determine the reliability of the Oswestry disability index     (ODI) Numerical Rating Scale (NRS), Pain Self-Efficacy Questionnaire (PSEQ) and the Major     Depression Inventory (MDI) in a chronic low back pain (CLBP) population referred to The     Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.   "
30492|NCT02886598|"     The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for     injection under the conditions of general clinical practice in Korea.   "
30016|NCT02892799|"     This is a research study about monitoring diuresis in acute respiratory failure. Often,     patients with respiratory failure have fluid building up in the lungs, which means less     oxygen can reach the blood stream, which deprives the organs of oxygen. Managing the amount     of intravenous fluids is crucial to the treatment of respiratory failure. Diuresis, the     increased formation of urine by the kidney, is one way that fluid balance is maintained.     Previous studies of respiratory failure suggest that diuretic therapy may be beneficial in a     group of patients with Acute Respiratory Distress Syndrome, (ARDS), which is a severe type of     respiratory failure. Although protocols exist for managing fluid status in ARDS, all of them     require invasive monitoring using a central venous catheter. This study will compare central     venous catheter-guided diuresis to ultrasound-guided diuresis. Participants in this study     will be randomized into one of three treatment arms:        -  Fluid and Catheter Treatment Trial-lite (FACTT-Lite) diuresis arm        -  Echocardiography diuresis arm        -  Central venous pressure CVP diuresis arm This research study will assess differences          in clinical outcomes, number of ventilator free days, ICU free days, 60 day mortality,          and incidence of acute kidney injury or new shock between the three treatment arms.   "
30017|NCT02892786|"     The dissemination of individual tumor cells is a common phenomenon in solid cancers.     Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic     situation is of high prognostic significance.      The objective of our study was to detect circulating tumor cells in two different method in     patient with head and neck squamous cell carcinoma .   "
30018|NCT02892773|"     The purpose of this study is to better understand how air is spread throughout study     participants' lungs after abdominal surgery by comparing two lung inflation treatments:        1. Incentive Spirometry (I.S.) lung expansion therapy        2. EzPAP® lung expansion therapy.      Lung expansion therapy is routinely used after upper abdominal surgery. Taking deep breaths     after surgery helps lungs to stay inflated. At the University of Virginia, it is at the     physician's discretion as to which treatment will be used to help with deep breathing lung     inflation therapy after surgery. The investigators would like to know which of the lung     inflation therapies is better at helping inflate participants' lungs.      The investigators will be using a device called Electrical Impedance Tomography (EIT) to     measure how effectively air spreads in participants' lungs. This device is not currently     approved by the Food and Drug Administration (FDA) for the purpose used in this study, and     therefore, it is considered investigational.      Investigators are inviting eligible participants to consider participating in this study     because doctors order Incentive Spirometry as a standard of care following upper abdominal     surgery. Information gained from monitoring how air is spread throughout participants' lungs     will help investigators to determine if there is a clinical difference and benefit when     comparing Incentive Spirometry and EzPAP lung expansion therapies.   "
30019|NCT02892760|"     The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment     approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.   "
30020|NCT02892747|"     The intervention tested in this research project aims to reduce the unplanned     hospitalizations in CHF patients by preventing the malnutrition using a personalized dietetic     education program. This new program provides concrete solutions to patients by offering     balanced menu ideas, adapted to their tastes and social-cultural habits, and a panel of     recipes easy to make, inexpensive and tasty (despite the lack of salt). This new educational     program should improve the dietary behavior of patients and reinforce the importance of     dietary guidance in support of the CHF.   "
30115|NCT02891512|"     The purpose of the study is to determine the effectiveness of the treatment with very low     frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated     signs such as sensitivity disorders that affect the first three fingers and half of the     fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (=     Xinepa).   "
30021|NCT02892734|"     The purpose of this research study is to look at the efficacy (the effect on tumor) and the     safety (the effect on body) of the study drugs when given as a combination in patients with     metastatic recurrent epidermal growth factor receptor 2 (HER2) negative inflammatory breast     cancer. This is a phase II study of 2 drugs used in combination: nivolumab and ipilimumab.     The combination of these drugs is already approved by the Food and Drug Administration (FDA)     to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are not approved     by the FDA for patients with metastatic recurrent HER2 negative inflammatory breast cancer,     hence the treatment is considered experimental or investigational.   "
30022|NCT02892721|"     Colorectal cancer (CRC) is an important United Kingdom healthcare issue affecting 1 in 20     individuals, half of whom will die from the disease. Late presentation of CRC has a poor     prognosis, whereas excellent cure rates (>95%) are seen in those who present early. Accurate     and early diagnosis of CRC is therefore crucial. In most patients this is achieved via     colonoscopy, a camera test which is widely available and allows tissue samples to be taken of     any abnormalities seen during the procedure. However, a non-invasive alternative is Computed     Tomography Colonography (CTC) which uses X-rays to produce images of the large bowel which     are then interpreted by Radiologists. CTC has high sensitivity for the diagnosis of CRC     (comparable to colonoscopy) and the cancer precursor - adenomatous polyps.      Unlike colonoscopy, however, there is no accreditation process for CTC and there is no     infrastructure to ensure that all reporting Radiologists are able to do so adequately and, as     a result, there is a wide range of diagnostic accuracy. There are no universally-accepted     standards to monitor quality or assess diagnostic performance, partly because we do not know     what the quality markers are and there is currently no system to quantify them. Overall, this     contributes to low cancer detection rates, missed cancers and inequity for patients across     the National Health Service (NHS).      This study aims to assess the impact of a structured training programme with assessment and     feedback on NHS radiologist performance. If the impact is positive and results in     significantly improved performance, then such a scheme could be adopted into an accreditation     programme for CTC in the English Bowel Cancer Screening Programme (BCSP).   "
30023|NCT02892708|"     The objective of this study is to evaluate the efficacy and safety of surgical resection in     elderly patients 70 years or older with a supratentorial glioblastoma de novo. The     sensitivity of Magnetic Resonance Spectroscopy with perfusion sequences in the diagnosis of     malignant glioma in the elderly will also be studied.   "
30028|NCT02892643|"     Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with     esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract     reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should     be negative for malignancy with intraoperative frozen biopsy.      Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with     esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc     lymph node dissection is mandatory. Resection margin should be negative for malignancy with     intraoperative frozen biopsy.   "
30029|NCT02892630|"     The pregnancy may activate flares of certain autoimmune diseases such as lupus. The influence     of pregnancy on the evolution of ITP was never studied while this pathology affects firstly     women old enough to procreate. Also, the influence of ITP on pregnancy (risk of obstetric     complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and     never studied in a prospective study. The realization of a prospective study to answer these     questions is necessary to allow us to inform better the patients affected by ITP and to     define better in this context the strategy of supervision of the mother, the foetus and the     newborn. The highlighting of risk factors of ITP flare or obstetric or neonatal complications     will indeed allow the implementation of prevention measures.      The conclusions of this study will allow us to adapt national guidelines for ITP during     pregnancy.   "
30030|NCT02892617|"     Low back pain is one of the most frequent reasons for consultation in rheumatology. There is     a strong correlation between low back pain, and the presence of a type of Modic 1 signal on     MRI.      The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on     T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the     endplates after gadolinium injection; it corresponds to a replacement of normal cancellous     bone of fibrovascular tissue.      The origin of this inflammatory process Modic 1 into the vertebra is still unknown.      infectious hypothesis was raised, including contamination by germs called slow-growth such     as Propionibacterium acnes (PA).      Many studies interesting Bacteriological analysis of disc material found the presence of     bacteria (prevalence between 0 and 54%).      A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo     in low back pain with Modic 1; a show effectiveness of this treatment on the different     clinical parameters evaluated.      However skin contamination is not formally excluded, particularly in patients previously     infiltrated (including epidural).      Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc     disease, and the possible presence of PA or other slow-growing bacteria in samples obtained     discal posterior approach would be related to intraoperative contamination or during     preoperative spinal infiltrations The main objective is to assess the prevalence of germs     slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type     1 Modic.   "
30031|NCT02892604|"     A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide     scale outpatient trials. Denominated as inControl , it includes improved user interface and     communication modules while closed-loop algorithms remain similar. During this pilot study,     the investigators will evaluate this new version of AP for a two-week period during which the     patients will use it for closed-loop insulin delivery 24/7 The main goal is train the     clinical team with the new system and collect patient opinions on system acceptance from     questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including     240 patients will be initiated. A total of 5 patients will be included in this training study     over a 4-week period.   "
30032|NCT02892591|"     This study investigates the ability of cannabis to reduce chronic back and neck pain and to     reduce sensitivity to an acute painful stimulus. Cannabis will be compared to both oxycodone     and a placebo.   "
30033|NCT02892578|"     Atrial fibrillation is the most common arrhythmia. Some studies shown that systematic     screening with electrocardiogram could improve atrial fibrillation detection. No studies are     available in nursing home. The goal of this study is to screen atrial fibrillation in     patients who live in nursing home.   "
30034|NCT02892565|"     The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an     increased risk of symptomatic and objectively confirmed first venous thrombotic event. This     is a case-control study in a population with patients having systemic lupus erythematosus     (SLE) and/or antiphospholipid antibodies (APL).      Secondary purposes are:        1. To determine the frequency of hypercoagulable phenotype in study population;        2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype          threshold on the importance of risk;        3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency          in different groups.   "
30035|NCT02892552|"     Objective: To evaluate the diagnostic concordance between multislice computed tomography     (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of     patients after cochlear implantation.      Study Design: Prospective, randomized, single-center, interventional, pilot study on the     diagnostic performance of a medical device.      Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan     after cochlear implant surgery.      Interventions: Nine patients were implanted with electrode arrays from three different     manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed,     and 2 experienced radiologists blinded to the imaging modality evaluated the randomized     images, twice.   "
30036|NCT02892539|"     The purpose of this study is to evaluate the radiation exposure in patients undergoing     coronary angiography, and to identify reference values for the main radiation doses     parameters.   "
30037|NCT02892526|"     The purpose is to determine intrinsic properties of various immunohistochemical markers     (FVIIIra, CD15, CD30, tryptase, TNFα, IL-1β, TGFα et TGFβ1) for diagnosis of vital wound,     alone and in association (evaluation of sensibility with surgery wounds and evaluation of     specificity with post-mortem wounds).      Secondary purposes are to measure the minimum time to obtain a positive labeling in vital     wounds, and to evaluate inter-observer reproducibility of vitality diagnosis with different     markers. Expression of microRNA miR 9, miR 21 et miR 198 will be also studied.   "
30080|NCT02891967|"     restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of     performance and durability of both restorations during one year follow up   "
30493|NCT02886585|"     This research study is studying Pembrolizumab as a possible treatment for this diagnosis for     metastases in the central nervous system (brain and spinal cord).   "
30038|NCT02892513|"     Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain     management regimens. However, they come at a cost with profound impacts on gastrointestinal     motility, respiratory depression, and even long-term dependence. Stimulating the external ear     with cutaneous electrical current is similar to acupuncture and could help improve     postoperative pain. The Bridge device (manufactured by Key Electronics [Jeffersonville, IN,     USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]), has been used     with success in treating opioid withdrawal and in animal studies has shown increases in pain     thresholds. The investigators propose a prospective, randomized, placebo-controlled,     double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain     and reduces opioid requirements for patients undergoing elective colon surgery.      pain perception in post-operative patients may be modulated via the auricular branch of the     vagus nerve. This has the potential to reduce the use of opioid medications, which will in     turn reduce the incidence of postoperative ileus and reduce patient need for and dependence     on narcotic pain medications. This would have an enormous economic impact due to decreased     length of hospital stays for patients who undergo abdominal surgery. In addition, opioid     reduction could potentially lessen the national crisis of opioid addiction.   "
30039|NCT02892500|"     This study evaluates the use of corticosteroids acutely as an adjuvant treatment of the high     ankle sprain. Subjects will receive either a corticosteroid or a local anesthetic injection.   "
30040|NCT02892487|"     Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation     indications have risen over the last decade, leading to a significant loss of quality of life     for patients. Recently, many retrospective studies and two evidence-based and systematic     reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward     benefit for a preventive swallowing exercise program.      The main hypothesis of this study is that an early active swallowing therapy can improve the     Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.      The study will be a randomized controlled, open-label, multicentric phase III clinical trial     comparing early active swallowing therapy versus non specific swallowing management (usual     care).   "
30041|NCT02892474|"     The purpose of the study is to find out if hybrid coronary revascularization (HCR) and     coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination     of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical     procedure to open up clogged heart arteries.   "
30042|NCT02892461|"     This study aims to determine whether umbilical cord milking can improve iron related health     outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord     milking, while the other half will receive routine clinical treatment and care.   "
30116|NCT02891499|"     The purpose of this study is to evaluate the effect of Low level laser therapy on stability     and displacement of orthodontic miniscrew implants using two different force application     protocols.   "
30950|NCT02880631|"     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM     NEO System in the commercial setting in subjects recently implanted under the CE-Marked     indication for resistant hypertension.   "
30043|NCT02892448|"     There may be a relationship between heart function and the metal ION levels in patients     having undergone total hip replacement. The idea is to use results from a clinical cardiac     MRI to assess heart function in a sample of 20 patients whom have also undergone     metal-on-metal hip replacement to determine whether having undergone this procedure may be     impacting heart function. In addition to the clinically used parameters, the images will also     be retrospectively assessed using special software to assess amount of fibrosis and early     changes affecting cardiac muscle contraction which may be indicative of impaired heart     function. With these values we will compare to known, and previously collected, hip     replacement and function data to determine whether there is any differences in how the heart     works in those having had a hip replacement relative to a normal population.   "
30044|NCT02892435|"     Comparison in abdominal wound healing after contaminated or dirty surgery with incisional     negative pressure wound therapy versus standard dressing.   "
30045|NCT02892422|"     To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.   "
30046|NCT02892409|"     To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with     bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth,     clarithromycin, amoxicillin, and lansoprazole.   "
30047|NCT02892396|"     This study evaluates the local and systemic inflammatory response in the airway in COPD     patients who consume electronic cigarettes compared with conventional cigarette smokers.   "
30048|NCT02892383|"     The aim of the project is to improve quality of life for multiple myeloma patients in the     future.   "
30049|NCT02892370|"     The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg     SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the     pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.   "
30050|NCT02892357|"     Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to     investigate the safety, tolerability and efficacy of Jianpi Qinghua granule combine and Low     dose omeprazole in patients with non-erosive reflux disease (NERD)   "
30051|NCT02892344|"     The purpose of the trial is to evaluate efficacy and safety of QMF149 150/80 microgram o.d.      delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms     of lung function and symptom control in poorly (ie inadequately) controlled asthma patients.     This study will assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.   "
30052|NCT02892331|"     African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians;     however, very little data are available on the effects of exercise training on type 2     diabetes risk factors in at risk African Americans. The present proposal will evaluate the     effects of 6 months of moderate versus vigorous intensity aerobic exercise training on     fitness, insulin sensitivity, mitochondrial capacity, skeletal muscle oxidative/insulin     sensitivity markers, adiposity, and quality of life in African Americans.   "
30494|NCT02886572|"     The purpose of this study is to determine the effectiveness and efficiency of Single     Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more     brain metastases   "
30053|NCT02892318|"     This is a non-randomized, open-label, Phase Ib study of atezolizumab in combination with     immunomodulatory agents for the treatment of participants with AML (relapsed-refractory and     treatment-naive, elderly participants unfit for induction chemotherapy). The study has been     designed with the intent, over time, to study multiple combinations of atezolizumab with     different immunomodulatory agents in AML participants (e.g., umbrella study design). The     study will begin with the evaluation of the combination of atezolizumab and guadecitabine     (Arm A). In the future, additional arms may be added.   "
30054|NCT02892305|"     The goal of this study is to evaluate and describe the surgical and overall outcomes of     subjects who undergo pancreatectomy and hepatic resection/ablation for pancreatic cancer with     low-volume hepatic metastases, as part of routine care. Subjects will be followed to     determine operative risks and 90-day morbidity and mortality. In addition, survival outcomes     will be compared to historical controls who did not undergo surgery. Secondary outcomes will     include mortality and morbidity; operative time; blood loss and transfusion requirements; and     oncologic outcomes such as: margin status, lymph node harvest, disease-free survival, and     overall survival. Analysis of subject and tumor characteristics will help the investigator     identify subjects who would benefit from this aggressive multimodal approach.   "
30055|NCT02892292|"     The objective of this study is to realize the typing of all HLA loci and validate this     technique with continued optimization of next-generation sequencing technology (NGS).   "
30056|NCT02892279|"     The adverse effects of air pollution on cardiovascular and respiratory health have been     demonstrated in an extensive series of epidemiological, observational and experimental     studies. In the current project the investigators aim to determine whether an acute exposure     to diesel exhaust causes impacts on sympathetic nervous system activation in healthy     volunteers.   "
30057|NCT02892266|"     This study is conducted to better understand Post-Traumatic Stress Symptoms (PTSS) in     adolescent transplant recipients and their parent/guardian and to see if PTSS play a role in     the way adolescent transplant recipients take their prescribed medicine.      Target population: medically stable adolescent solid organ (e.g., heart, kidney, liver, lung,     small bowel) transplant recipients and their parent(s)/guardian.   "
30058|NCT02892253|"     This Randomized Controlled Trial evaluates the clinical impact of parathyroid     autofluorescence visualization using near infrared light (NIR) during total thyroidectomy     (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND)     with NIR vs without NIR use during surgery.   "
30071|NCT02892084|"     This project will evaluate two different methods of normalizing the center of mass     acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern of     recovery to analyze walking-specific adaptations as precursors to motor learning. In     addition, the proposed project seeks to establish the optimal configuration of electrodes to     activate neural circuits involved in post-stroke locomotion. Once the better method of     training COMa and optimal parameters of electrode placement for tDCS are identified, the     investigators will evaluate the effects of tDCS on locomotor adaptations during single     sessions and over a five-day training period.   "
30072|NCT02892071|"     Tri-split face study of skin resurfacing modalities for the treatment of melasma, comparing     the medium depth trichloroacetic acid peel, CO2 laser and Qs-NdYag laser.   "
30059|NCT02892240|"     In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures     at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is still     relevant and in use today.      Many studies have sought to determine if the treatment had to be surgical or orthopedic.     Although the standard treatment of displaced fractures of the acetabulum is the reduction and     osteosynthesis, some advocate the THA in elderly patients with comminuted fracture of the     acetabulum, impaction of the femoral head or acetabular impaction affecting more than 40% of     the articular surface and including bearing zone. All these treatments and those supported     have been studied in the literature.      However the study of the laying of total hip remote trauma after acetabular fracture     osteosynthesis or treated conservatively, is not rich in literature. Only a few articles have     been published in recent years.      Indeed, a recent review of the literature are nearly 11 series focusing on the results     remotely hip prostheses for treatment of acetabular fracture. These two prospective series     with between 21 and 63 patients. All authors report rates well above those reported     complications for primary arthroplasty, with a revision of rates ranging between 0 and 26.5%.      Fractures of the acetabulum are covered in our service by one operator using the same release     technique based on the stiffening. The objective of this study is to determine whether the     systematic surgical treatment of these patients by an experienced operator reduces the high     complication rate.   "
30060|NCT02892227|"     Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and     reproducible estimation of filling pressures with an evaluation of mitral inflow and the     inferior vena cava, allow a more reliable estimate of the true blood volume of the patient     and thus lead to a therapeutic adjustment more suitable.      This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30     days and mortality, less alteration of biological parameters myocardial, kidney and liver.   "
30061|NCT02892214|"     The proposed study will evaluate how personality characteristics, cognitive factors and the     emotional and behavioral responses of patients with provoked vestibulodynia (localized     provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to     therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional     health and sexual functioning.   "
30062|NCT02892201|"     This is a phase II study for patients with squamous cell carcinoma of the head and neck who     have residual disease following definitive therapy with radiation (with or without systemic     therapy). Patients must be diagnosed with residual disease within 24 weeks of completion of     radiation therapy. Residual disease must be biopsy proven before the patient can consent to     the trial, and can be either from lymph nodes in the neck, or from the primary tumor site.     Prior to beginning study therapy patients are evaluated by an ENT to determine if they have     disease amenable to surgical resection. Both resectable and unresectable patients will be     eligible for participation in the study.   "
30063|NCT02892188|"     The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a     physician-pharmacist collaboration.   "
30064|NCT02892175|"     The Leonetti law of 22 April 2005 on the rights of patients at end of life provides the     opportunity for all adults to write advance directives in case she would one day be unable     to express their will. If this right is enshrined in the hospitalized patient's charter,     brought to the attention of any patient entering a hospital, the fact remains that only 2.5%     of the deceased have written advance directives (study National Institute of demographic     studies published in 2012).      Moreover, according Régis Aubry, a researcher at the observatory on the end of life, the     conditions of the end of life are insufficiently discussed with patients and their families     and can lead to difficult situations conflicting view. Now, thinking about advance directives     should allow an exchange on the conditions of the end of life desired by patients.      Sicard report of December 2012 concluded that such legislation is known neither patients nor     doctors. This is the first obstacle to its use, even if major psychological barriers exist     both in patients that their doctors.      It is in this context that Valls government asked MM. Claeys and Leonetti to propose a new     bill on the subject. The bill provides that advance directives will no longer be valid for 3     years, but until changed or until the patient's death, and they can be invoked against     doctors except emergency or illegality. In addition, to complete the bill, the Ministry of     Health commissioned the National Health Authority (HAS) writing a form of advance directives,     as well as a doctor's information guide and patient on the subject. The working group is     chaired by Professor Sicard. Among the recommendations made to physicians (and by extension     health professionals), the investigators accept that talk of advance directives as often as     possible and as early as possible, even in the absence of commitment in the short or medium     term prognosis .   "
30065|NCT02892162|"     Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due     to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study     indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with     the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF     to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized     that AF should not be initiated or sustained if the latter crucial regions for AF maintenance     are abolished. This study aimed to describe the efficacy and safety of additional linear     ablation on the left atrial anterior wall for PerAF.   "
30066|NCT02892149|"     A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance     treatment of anemia in subjects with DD-CKD   "
30067|NCT02892136|"     This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate     pediatric patients with cardiovascular disease,congenital heart disease in patients of all     ages, fetuses undergoing clinically indicated MR imaging.   "
30068|NCT02892123|"     To evaluate the maximal tolerated dose (MTD), optimal biological dose (OBD) or other     recommended dose (RD), and overall safety and tolerability of ZW25 in patients with locally     advanced (unresectable) and/or metastatic HER2-expressing cancers.   "
30069|NCT02892110|"     Marijuana is the most commonly used illicit drug. There is high demand for effective     interventions for cannabis use disorder, yet few specific treatments for have been developed.     This study will evaluate the efficacy of varenicline for reducing marijuana use in people who     use marijuana frequently.   "
30070|NCT02892097|"     The purpose of this study is to test the effects of three different rehabilitation training     sessions that combine non-invasive brain stimulation (transcranial direct current     stimulation, tDCS) with arm rehabilitation training (repetitive task-specific practice, RTP)     for individuals with unilateral spatial neglect following stroke. This study is designed to     determine the effects of tDCS + RTP on the excitability in the brain, attention to the     affected side, and arm movement ability.   "
30073|NCT02892058|"     The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is     justified by the opportunities for development of clinical trials targeting hip and knee OA     long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of     symptoms. Such treatments are currently under development and will likely bring important     changes in the treatment of patients. The development of a Flare-OA tool would be essential     to capture the occurrence of flare, and to implement and adapt treatment strategies.      This project was elaborated with the aims to:        1. define the construct through development of a conceptual framework        2. use the conceptual framework to inform the development of a patient-reported outcome          measure, Flare-OA tool, for people with OA        3. evaluate the psychometric properties of the new measure using the OMERACT (Outcome          Measures in Rheumatology) filter 2.0 and Rasch measurement methods.   "
30074|NCT02892045|"     A new NMT module from Mindray (Mindray Co. Shenzhen, People's Republic of China.) claims to     measure 3 directional accelerography. The aim of the study is to compare the neuromuscular     block of rocuronium 0.6 mg/kg (twice the 95% effective dose, ED95) monitored by the NMT to     that monitored by the Relaxometer mechanomyograph, and to clinically evaluate the new system     for its diagnostic accuracy.   "
30075|NCT02892032|"     This study aims to examine the effects of smartphone-based Attention-Bias Modification     Training (ABMT) in chronic pain participants.   "
30076|NCT02892019|"     This study is designed to explore lung function effects of two doses of indacaterol acetate,     75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic     exposure to indacaterol in plasma with historical data in adults, to identify an appropriate     dose to Phase III evaluation.   "
30077|NCT02892006|"     Managing distress and improving well-being is critically important for optimal survivorship     care. Treatment of distress leads to better adherence to treatment, better communication,     fewer calls and visits to the oncologist's office, and avoidance of development of severe     anxiety or depression. Based on national guidelines, distress is typically managed with     pharmacologic options (i.e. benzodiazepines), support groups, individual counseling, or     chaplaincy services. To our knowledge, the role of a structured improvisational comedy     (improv) program in reducing distress and improving well-being has never been evaluated in     the oncology setting.   "
30078|NCT02891993|"     The purpose of this research study is to address the challenge of symptom management for     hospitalized patients with cancer.   "
30079|NCT02891980|"     This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity     of two heterologous and two homologous prime-boost regimens using MVA-BN®-Filo and Ad26.ZEBOV     administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45     years.The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics,     metabolomics), antibodies for immunogenicity, CMI, ADCC, lymphoproliferative and plasmablast     responses to MVA-BN®-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are:     1) To Assess the safety and reactogenicity of each study group. 2) To assess responses to the     study vaccination by study group after the first, second and third dose by transcriptomics.     3) To assess the peak antibody response to the study vaccination by study group to filovirus     antigens.   "
30081|NCT02891954|"     Five daily doses of canagliflozin (300 mg) will be administered to healthy volunteers.     Pharmacodynamic responses to canagliflozin will be assessed both at 2 days and 6 days after     administration of the first dose of canagliflozin. A genome-wide association study (GWAS)     will be conducted to search for genetic variants that are associated with each of the     pharmacodynamic responses to canagliflozin.   "
30082|NCT02891941|"     This exploratory study aims to identify the most promising biomarkers that alone or in     combination might predict development of mood disorders [i.e., major depression (MD],     cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment     following repetitive/mild traumatic brain injury (MTBI).   "
30083|NCT02891928|"     The purpose of this study is to determine if the wearing of shoes rocker sole type     prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of     equilibrium.   "
30084|NCT02891915|"     This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical     trial will test the effectiveness of short (5-day) vs.standard (10-day) course therapy in     children who are diagnosed with CAP and initially treated in outpatient clinics, urgent care     facilities, and emergency departments. Primary objective is to compare the composite overall     outcome (Desirability of Outcome Ranking, DOOR) among children 6-71 months of age with CAP     assigned to a strategy of short course (5 days) vs standard course (10 days) outpatient     beta-lactam therapy at Outcome Assessment Visit #1 (Study Day 8 +/- 2 days)   "
30085|NCT02891902|"     The purpose of this study is to evaluate in a multicentric cluster randomized study the     effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial     infections. The rate of bloodstream infections per 100 admitted patients is used as the main     endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the     objective to show a reduction of one third of the rate of ICU-acquired bloodstream     infections. The study is currently at the end of the recrutimeent phase.   "
30086|NCT02891889|"     The aim of this study is to investigate aspects of brown fat in scanner with injection via     the PET-CT study.   "
30087|NCT02891876|"     Biodentine® is a most recent material for direct pulp capping. The aim of this study is to     determine the 3 months success rate (defined as clinical and radiographic successes together)     of direct pulp capping realized with Biodentine®.   "
30088|NCT02891863|"     The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study     that will assess and characterize early safety and effectiveness of low energy therapies in     converting monomorphic ventricular tachycardias (MVTs).   "
30089|NCT02891850|"     To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5     inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients   "
30090|NCT02891837|"     The purpose of this study is to determine whether L-citrulline is effective and safe in the     prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery     for congenital heart defects.   "
30093|NCT02891798|"     After total joint replacement, early hospital discharge to home (with patients capable of     continuing a home-based rehabilitation program) is a cost- effective management strategy.     This project will use improved local anesthetic nerve block techniques to enhance technical     capability and clinical practice by (i) reducing pain and other morbidities during recovery,     (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for     earlier return home, and (iii) continued rehabilitation as an outpatient at home when     feasible (versus in an extended care facility).   "
30094|NCT02891785|"     Background: Significant barriers to cancer pain management are patient-related. So far,     cancer pain self-management support interventions have only been tested in strictly     controlled settings of randomized controlled trials (RCT) and thus evidence for comparative     effectiveness is lacking.      Methods: This study includes a multicenter cluster RCT with a stepped wedge design and a     qualitative substudy. The aim of the study is to evaluate the implementation of ANtiPain in     clinical practice. The primary patient-related aim is to improve pain interference with daily     activities. Secondary patient-related aims are pain intensity, barriers to pain management,     self-efficacy, and quality of life. Secondary organization-related aims are nurse proficiency     and satisfaction with cancer pain self-management support, participation rates, and     implementation fidelity.      Inclusion and exclusion criteria: On 17 wards in 3 hospitals in Vienna adult oncology     patients will be included (n=150 pre-, n=150 post-implementation) if they are admitted to one     of the participating wards, have pain ≥3 (0=no pain to 10=worst imaginable pain) or regular     pain medication, able to understand German, discharged with pain self-management, and give     informed consent. Patients with signs of disorientation that may severely limit pain     self-management will be excluded.      Interventions: Pre-implementation, patients receive standard care. Post-implementation,     patients receive ANtiPain which is based on 3 key strategies: information, skills building     and nurse coaching and consists of in-hospital sessions by staff nurses and follow-up phone     calls after discharge. The implementation process will include training of the designated     staff nurses, case discussions, as well as measures to ensure sustainability of the     implementation (e.g., training of clinical nurse specialists).      Procedures: Wards are randomized according to the stepped wedge plan. Patients will complete     questionnaires at admission, and 2, 4 and 8 weeks after discharge. Nurse-level data will be     collected before implementation and 1 and 3 months after implementation. Data on ward and     hospital level will be collected at the beginning of the study.      Statistical analysis: The statistical analysis will be conducted based on mixed models, with     a random intercept for the respective ward and time as a covariate.      Qualitative substudy: The qualitative substudy will comprise interviews with head and     intervention nurses about their views of the implementation.   "
30095|NCT02891772|"     Hypotension often happens immediately after anesthetic induction. Particularly in 5-10     minutes after anesthetic induction it is reported to happen more frequently. Patients may     have preexisting hypovolemia resulting from dehydration and impaired compensatory responses,     which increase the risk. However, it is still challenging to assess intravascular volume     status in spontaneously breathing patients before anesthetic induction. Recently, the     measurement of corrected flow time in carotid artery was introduced as quite useful, simple     and noninvasive for the evaluation of circulating blood volume. The aim of this study is to     evaluate whether corrected carotid artery flow time as determined by ultrasonography in     spontaneously breathing patients before general anesthesia can predict hypotension after     induction.   "
30121|NCT02891434|"     The task consists in reach as much bubbles as they can, the bubbles appear on the screen of     the computer and should be reached in 10 seconds. To accomplish that, three different devices     will be used: (1) Kinect for Windows Microsoft - which consists of a sensor that captures     body movements (including upper limbs). And (2) the Leap Motion (LMCH, Leap Motion, Inc., San     Francisco, CA, USA), and (3) Touch Screen. To describe motor impairments was used the Motor     Function Measure Scale; Scale Vignos and Scale Egen Klassifikation;   "
30495|NCT02886559|"     Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the     treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The     investigators designed a new regimen, including chidamide, decitabine, aclarubincin,     cytarabine and G-CSF, to treat rrAML.   "
30096|NCT02891759|"     This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm     Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal     matrices (ADM) offered by both vendors and can be used for post-mastectomy breast     reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm     Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction,     these ADMs are used in the same manner. They may be inserted with a tissue expander     immediately after skin- or nipple-sparing mastectomy. The investigators will examine     breast-reconstruction associated complication rates, pre- and post-operative patient reported     outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs.     The endpoint will be either exchange of the tissue expander for a permanent breast implant or     autologous flap, explantation due to patient preference, development of a complication, or     less common reasons. The investigators propose that Cortiva 1mm Allograft Dermis and Alloderm     RTU will have equivalent complication and patient reported outcome rates as well as physician     reimbursement, but that direct hospital cost will be less with Cortiva 1mm Allograft Dermis.   "
30097|NCT02891746|"     The aim of the study is to characterize and monitor the microbiome of premature infants born     in the investigators facility until discharge from the NICU. The investigators will also     examine the relationship between mode of delivery and the microbiome of the infant, while     exploring various possible factors that may affect it. In addition, the investigators will     compare the microbiome of premature infants to the microbiome of term babies born at the same     time in the same facility.   "
30098|NCT02891733|"     Lung cancer is the leading cause of cancer mortality in France and worldwide. 60% of patients     present themselves with a disease diagnosis immediately metastatic non curable.     Adenocarcinomas account for 50% of incident tumors. Treatment is based on the platinum-based     chemotherapy with or without maintenance therapy. When there is to exhaust this first line, a     second line treatment is offered to the patient. Three drugs are allowed in this situation:     docetaxel, erlotinib (inhibitor of the tyrosine kinase activity of the receptor for epidermal     growth factor - TKI-EGFR) and pemetrexed (which in fact has become virtually standard in     first online and in combination with platinum in all patients with non-squamous cancer, so     that his place is in second line reduced facto). There is no recommendation for treatment in     third line situation where only erlotinib is allowed.      Most recently, the nivolumab, anti-PD1 monoclonal antibody (which aims to enable immunutaire     system) saw its demonstrated effectiveness in the second line and beyond in the two Phase 3     trials where it was compared with docetaxel for the treatment of squamous cell carcinoma and     non-squamous. The very recent availability in France of the drug under an ATU fact that it     will most likely become a standard second line, which will tend to place the third line     docetaxel.      Therefore, erlotinib will be in 4th line situation. However, in the absence of an EGFR     mutation (which is only seen in more than 10% of Caucasian patients) use of the drug does not     seem appropriate or even harmful. A selection of patients likely to benefit from the     prescription of EGFR TKI-is essential.      Neurotensin (NTS) is a polypeptide of 13 amino acids present and active in the central     nervous system and the periphery. At the peripheral level, neurotensin is secreted     postprandial by endocrine cells in the intestinal mucosa and is involved in the motor     functions of the gastrointestinal tract. The effects of neurotensin pass through the     activation of three subtypes of receptors which, mainly, NTSR1 and NTSR2 which are receptors     coupled to G proteins in the extra-digestive normal tissues, including lung, torque NTS /     NTSR1 n is not expressed physiologically. Rather, this complex is likely to recur in tumor     tissues.      The mechanism of this effect is derogatory activation torque NTS / NTSR1 of matrix     metalloproteinases which causes the release by the cell membrane ligands EGF-like and thus,     activation of HER receptor (EGFR or HER1, HER2 and HER3). Indeed, in experimental tumors     created by subcutaneous injection in athymic mouse cell lines adenocarcinomas NTS + / NTSR1 +     (non-mutated EGFR), treatment with erlotinib - which blocks EGFR pathway - causes a     significant decrease of tumor growth.      Expression of the neurotensin receptor in cancer cells metastatic primary bronchial     adenocarcinoma is not known. Therefore, its pejorative prognostic value is not confirmed in     the metastatic setting.   "
30099|NCT02891720|"     The goal of this study is to evaluate an integrated technology system that confirms ingestion     of oral PrEP, monitors adherence both in real-time and longitudinally, and provides visual     feedback mechanisms to promote enhanced adherence behaviors.   "
30100|NCT02891707|"     This joint research project between the Department of Veterans Affairs (VA) and Department of     Defense (DoD) will demonstrate that the implementation of the Mobile Device Outcomes-based     Rehabilitation Program (MDORP) will improve the quality of rehabilitative care at a decreased     cost to the healthcare system and a reduced burden for service members (SMs) and veterans     with lower limb loss. The development of the MDORP will be executed by a multisite     translational clinical care team that will use web-based mobile computing devices designed to     assess mobility, enable remote prescription of targeted exercise program, and provide     continual measureable outcomes to document the continuum of care with the intent of     maximizing prosthetic performance while minimizing adverse medical events. The information     obtained from this web-based mobile device application will be used by clinicians to promote     continuity of care from the DoD and VA facilities nationwide to the community and at home.   "
30101|NCT02891694|"     Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a dystrophy     of the basement membrane or following corneal trauma. This syndrome is characterized by     recurrent episodes of ocular pain more or less associated with localized separations between     the outer epithelium and the epithelial basal lamina (basement membrane) because of anchorage     abnormalities between these two corneal layers. This could be the result of an increased     expression of metalloproteinases cleaving the hemidesmosomes which anchor epithelium to the     basement membrane.      The investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of     matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of     such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3     in the RCE syndrome.   "
30102|NCT02891681|"     To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in     predicting and monitoring early neoadjuvant treatment response compared to pathological     response.   "
30103|NCT02891668|"     This project has the following primary aims:      The main objective is to delineate the association between changes in Resting energy     expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4     treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid     patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after     1 year of treatment.      Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes     in cognitive function and changes in body composition before and after one year of treatment     and furthermore changes in insulin resistance following changes in body composition and free     fatty acids (FFA).   "
30104|NCT02891655|"     Corneal stromal thinning observed in keratoconic eyes could result from an increased     synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an     overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3     by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases     (MMP) may be observed between the apex of the keratoconus and the peripheral cornea.     Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of     specific inhibitors to slow or to stop keratoconus evolution.   "
30105|NCT02891642|"     The purpose of the current study is to establish a Liquid biopsy method (positive enrichment     by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous     effusions and to evaluate its sensitivity and specificity for clinical application.   "
30106|NCT02891629|"     The EyeControl device is an eye movement-based communication device in the form of wearable     glasses with connected infrared cam-era that tracks the pupil and translates blinks and     movements into commands.This study is aimed to demonstrate the safety and feasibility of the     EyeControl device in healthy volunteers, and ALS patients in early stages.   "
30122|NCT02891421|"     The project partnered with U.S. military veterans with a premier accredited therapeutic     riding center for six weeks. The veterans interacted with horses by grooming and learning     about them, as well as riding them for one hour per week during which they gained a variety     of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress     Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and     emotional health and self-efficacy.   "
30123|NCT02891408|"     The primary objective of this study is to evaluate the single-dose pharmacokinetics (PK) of     GS-0976 in adults with normal hepatic function, and mild, moderate, or severe hepatic     impairment.   "
30124|NCT02891395|"     Open label non-randomized multicenter phase 2 trial with direct individual benefice   "
30107|NCT02891616|"     In the current study, advanced positron emission tomography/computed tomography (PET/CT) and     positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to     validate our hypothesis that melanoma patients receiving Dual-Immune Checkpoint Blockade     (DICB) therapy, who ultimately achieve clinical benefit, will have an increase, or FLARE,     in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that     after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in     comparison to the patients classified as non-responders. In addition, alterations in tumor     apparent diffusion coefficient (ADC) on diffusion-weighted magnetic resonance imaging     (DW/MRI) will be evaluated, expecting after cycle#1: transient reductions in ADC due to     lymphocyte proliferation, increased cellularity and restriction of water movement in     responding patients, with these patients tumors having increased ADC at 2 cycles into therapy     associated with tumor necrosis. This study will evaluate rather early PET imaging with FLT     and FDG is a useful imaging biomarker of response to DICB.   "
30108|NCT02891603|"     The purpose of this study is to examine a new approach to preventing a serious problem after     transplant called graft vs. host disease (abbreviated as GVHD).      This is a single-arm, phase I/II, study of Pacritinib with Sirolimus and Tacrolimus     (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated allogeneic     hematopoietic cell transplantation (alloHCT).   "
30109|NCT02891590|"     The Primary Objective is to evaluate the safety and tolerability of multiple dose oral     administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.      The Secondary Objective is to evaluate the pharmacokinetics of multiple dose oral     administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.   "
30110|NCT02891577|"     This study aims to describe the ratio of the diameter of inferior vena cava to the common     femoral vein measured by ultrasonography in critically ill patients with shock, and to     evaluate the potential link between this ratio and the existence of intra-abdominal disease.   "
30111|NCT02891564|"     Project:EVO is a video-game based intervention that targets neural networks associated with     cognitive control. The same networks have been implicated in poor treatment response in     middle and older aged adults suffering from major depression. Related work has demonstrated     that healthy older adults show significant improvement in cognitive control. In a very small     sample of older adults suffering from depression (n=12), we found similar improvements in     selective attention and working memory after 4 weeks of intervention, along with improvements     in mood comparable to participants receiving an evidence-based psychotherapy. The intent of     this proposal is to first determine if at least 2/3 of participants who use Project:EVO for     four weeks demonstrate significant improvements in the function of these neural networks, and     if improvements are observed, to conduct a second study to see if changes in neural network     functions are associated with changes in mood. If we show that Project:EVO improves neural     function and mood to a greater degree than a placebo cognitive training game, we will be in a     position to move onto the next phase of study, which is to demonstrate the intervention's     efficacy in a much larger sample of adults with depression.   "
30112|NCT02891551|"     The study design is a prospective, non-interventional, observational single arm study.      A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites     in the Netherlands. In all cases, the decision to treat the patient with azacitidine was     already made prior to the decision to enter the subject into the study.      Recruitment will continue until end of June 2015, provided a minimum of 150 patients have     been included in the study. When this date is reached, all patients on azacitidine will     continue to be followed until the last patient enrolled has been followed for 12 months.   "
30113|NCT02891538|"     This will be a randomized, controlled pilot trial of patients with histological documentation     of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any     treatments for cancer. If patient is a candidate for surgical resection, with no planned     neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be     consented prior to surgery.   "
30114|NCT02891525|"     In this study, the investigators aimed at evaluating the role of sweet taste receptors in the     gastrointestinal tract (GIT). Intragastric administration of glucose, fructose or     acesulfame-K were compared with placebo administration for their effects on gastrointestinal     motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and insulin)     and hunger feelings.   "
30951|NCT02880618|"     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM     NEO System in the commercial setting in subjects recently implanted under the CE-Marked     indication for heart failure with reduced ejection fraction (HFrEF).   "
30117|NCT02891486|"     Post-operative wound infections can prolong hospital stays, increase rates of readmission to     the intensive care unit, and increase the costs of treatment significantly. This study will     conduct a prospective chart review of all patients undergoing elective spinal surgery on both     the neurosurgery and orthopedic spine services at two facilities on an academic campus. The     investigators will collect the data of those patients who develop post-surgical infections.     This data will then be analyzed and compared to published data from other studies. The aim of     this investigation is to passively collect this infection data, which may ultimately provide     needed baseline incidence rates using current and standard protocols.   "
30118|NCT02891473|"     The purpose of the study is to evaluate the effectiveness of a rehabilitative approach using     breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi     muscle according to the Mézières Method to improve balance and posture and relief pain in     patients with Parkinson's disease.   "
30119|NCT02891460|"     The purpose of this study is to evaluate the clinical response of the tumors within the     bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at that     time as TheraCoat Ltd.) TC-3 Sterile Hydrogel (TC-3) and to evaluate the patency of ureters 6     hr post instillation.   "
30120|NCT02891447|"     The goal of this clinical research study is to learn whether cytoreduction surgery (surgery     to reduce or remove lesions), gastrectomy (where all or part of the stomach is removed), and     hyperthermic intraperitoneal chemoperfusion (HIPEC, a heated chemotherapy treatment delivered     directly inside the abdomen during surgery) can help control the disease in patients with     gastric and/or gastroesophageal cancer. The safety of these procedures will also be studied.   "
30126|NCT02891369|"     The refractory malignant ascites is a complication of advanced stages of many cancer types.     It is characterized clinically by abdominal pressure sensation, shortness of breath and     pelvic pain. Thus, it contributes to decreased quality of life for these patients in     palliative care.      Conventional treatment is based on paracentesis of ascites. The progression of the disease     leads to increased production of ascites requiring more frequent paracentesis. Main     therapeutic alternatives are constituted by the controversial use of diuretics and the use of     an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF):     bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the     treatment of refractory malignant ascites showed no sufficient clinical benefit.      VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and     capillary filtration surface generating increased protein extravasation. These phenomena are     responsible for an increase of the volume of ascites product. Thus the use of inhibitors of     VEGF, such as bevacizumab, could reduce the production of ascites.      The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on     small animals in intraperitoneal administration.      Studies in humans are few and the doses used are not consistent from one study to another.   "
30127|NCT02891356|"     The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to     play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines     that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the     relationship in anorexia nervosa patients with change in bone mineral density and adipokines     like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia     nervosa patients at inclusion and every two years during 6 years.It is assessed blood and     urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin,     adiponectin and Préf-1)   "
30128|NCT02891343|"     The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because     of the lack of predictive end-point. The use of a battery including different parameters     could improve this early development. In healthy volunteers, to test the reverse effect of     symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment     and cerebral activity changes by a challenge test. In this context, a transient hypoxia could     be relevant.   "
30129|NCT02891330|"     The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due     to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related     symptoms occur very early after eating (within 30 minutes), are not associated with     concurrent hypoglycemia, and are most prominent in the early postoperative period. This     syndrome very debilitating for the patient can be improved by dietary and nutritional     recommendations. We hypothesize that a personalized approach based on dietary and nutritional     recommendations conducted by a nurse would likely to decrease the frequency of dumping     syndrome and improve the postoperative quality of life of patients in the early postoperative     period.   "
30130|NCT02891317|"     The purpose of this study is to assess how surgical interventions in glaucoma affect 24-hour     intraocular pressure, 24-hour ocular perfusion pressure, optic nerve blood flow, and retinal     oxygen saturation.   "
30131|NCT02891304|"     Hypothesis: ACE tool for colonoscopy and EGD allows for reliable standardized learning     curves, competency benchmarks, and creation of a centralized database that compares trainee     performance amongst peers. Trainees receiving quarterly learning curves achieve competence in     endoscopic procedures at a faster rate (ie less procedures) compared to trainees receiving     usual feedback on endoscopic performance as established by their respective GI fellowship     program.      Aims: To compare the number of procedures necessary to achieve competence in EGD and     colonoscopy between trainees receiving learning curve performance feedback every three months     in addition to standard feedback versus trainees receiving annual learning curve performance     feedback in addition to standard feedback for these endoscopic procedures. To demonstrate the     feasibility of development and adoption of a centralized database that would allow program     directors and general GI trainees to generate performance reports in relation to national     peers to provide real-time targeted performance feedback during training and evaluate trainee     and GI fellowship program directors predictors of competence.   "
30132|NCT02891291|"     Optical coherence tomography is technology widely used in medicine. In this study, the     investigators will use an optical tomographic scanner to scan skin tissue image.   "
30133|NCT02891278|"     This is a Phase I study with the goals of determining the feasibility, safety, and toxicity     of administering sertraline in combination with timed-sequential cytosine arabinoside (ara-C)     in adults with relapsed and refractory acute myeloid leukemia.      Primary objective:        -  To define the maximum tolerated dose (MTD) and Recommended Phase II Dose (RP2D) of          sertraline administered in combination with timed-sequential cytosine arabinoside in          adult patients with relapsed and refractory acute myeloid leukemia.        -  To evaluate the safety and tolerability of sertraline given in combination with          timed-sequential cytosine arabinoside in adult patients with relapsed and refractory          acute myeloid leukemia.   "
30134|NCT02891265|"     Tobacco use is the leading preventable cause of death contributing to more than 5 million     estimated deaths per year globally. The longterm negative effects of smoking are well     established. Complications due to smoking, from an orthopaedic perspective include impair     bone and wound healing, and increased risk of infection and osteomyelitis.      The primary outcome of this research is smoking cessation in patients attending the     orthopaedic fracture clinic. This is a unique environment whereby previously healthy patients     are faced with the impact of disability. This impetus to abstain from the benefit of fracture     outcomes provides an opportunity for previously unattained early intervention and thus a     greater potential for decreased patient morbidity and mortality. Furthermore it is a high     volume clinic that, given the unique nature of traumatic injuries consists of a high     proportion of males, ages 24-34 years old, obliged to follow up. This population is     traditionally regarded as unattainable from primary prevention smoking cessation strategies.     The investigators hypothesize that The Ottawa Hospital Fracture Clinic will serve as an     effective environment to employ established primary prevention smoking cessation     interventions, reducing the incidence of complications associated with fracture and surgical     healing, and result in greater long-term cessation rates.   "
30135|NCT02891252|"     hemithyroidectomy as a outpatient procedure is performed in some countries, it has never been     done a RCT whether it is feasible   "
30136|NCT02891239|"     This is an open-label, multi-center study. Subjects in this study will receive up to eight     (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm     wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one     follow‐up (FU) visit at the clinic at 8 weeks following the last treatment.   "
30137|NCT02891226|"     The purpose of this study is to evaluate the safety and effectiveness of the study drug     Mirikizumab in participants with active Crohn's Disease.   "
30138|NCT02891213|"     Systemic Lupus Erythematosus (SLE) is the most common systemic autoimmune disease. The     clinical manifestations are severe and affect multiple target organs such as the kidney,     central nervous system, skin, heart and joints. Despite the progress made in the therapeutic     approach with new immunosuppressive regimens, morbi-mortality is still high. Therefore, it's     important to identify new biomarkers to help clinicians to predict severity and evolution of     the disease for better adaptation of treatments and try to improve the prognosis.      RAGE (Receptor for Advanced Glycation Endproducts) :      RAGE (Receptor for Advanced Glycation Endproducts) is an ubiquitous membrane receptor,     involved in development of many diseases such as diabetes, chronic renal failure but also in     vascular remodelling, inflammatory, infectious deseases and cancer. RAGE regulates a number     of crucial cell processes like inflammation, and tissue and cellular homeostasis.      RAGE is able to bind not only the advanced glycation end products (AGEs) such as pentosidine,     carboxymethyllysine (CML), methyl-glyoxal-hydroimidazolone-1 (MG- H1), but also other ligands     such as HMGB1 (high mobility group box1), and S100A8/A9 proteins which have been correlated     in recent studies to the activity index of SLE. The activation of RAGE leads to a cascade of     intracellular signaling and activation of the transcription factor NF-ΚB . NF-ΚB enable the     traduction of proinflammatory cytokines such as IL-6, IL-1α ,IFN-γ. In SLE, these cytokines     involved in perpetuation of inflammation and tissue damages including lupus nephritis.     Moreover, the activation of RAGE induces the expression of adhesion molecule such as sICAM -1     and sVCAM -1 wich were recently involved in SLE vasculitis.      Soluble forms of RAGE, sRAGE and esRAGE :      RAGE is a proinflammatory membrane receptor. But RAGE also exists in soluble plasma forms,     esRAGE (secreted form) and sRAGE (a truncated form as cleaved by MMP9 and ADAM10 enzymes).     esRAGE and sRAGE have the same ligand-binding specificity as RAGE and may function as a     'decoy receptor' by binding pro-inflammatory ligands and preventing them from accessing cell     surface RAGE (Kierdorf and Fritz, 2013). Therefore, both soluble forms have an     anti-inflammatory action. Several studies have shown a decrease in circulating levels of     sRAGE in patients with Rheumatoid Arthritis, or Sjögren Syndrome compared with healthy     controls. However, the role of RAGE in SLE remains unknown.      RAGE and Systemic Lupus Erythematosus, recent advances :      Our team (Laboratory of Nephrology, CNRS UMR 7369, URCA) showed in a study in lupus RAGE     knockout mice (B6/ MRL-FAS lpr/J RAGE-/-) a strong involvement of RAGE in systemic     manifestations SLE. Recently, another report showed that sRAGE has an anti-inflammatory     effect on the lupus nephritis and could be a potent therapy in mice.      In humans, two studies show a correlation between the plasma level of sRAGE and lupus     phenotype ( Nienhuis et al. , 2008).      Working hypothesis :      Based on the results and those of the current studies, the investigators think that RAGE axis     and its soluble forms play a crucial role in the complex pathogenesis of SLE.      The investigators hypothesize that plasma levels sRAGE and esRAGE are a reflection of the     activity and the development of SLE in humans. Soluble forms of RAGE and ligands may be novel     biomarkers of SLE and sRAGE a potent therapeutic target.   "
30139|NCT02891200|"     The study is to compare the effectiveness of two health communication and dissemination     strategies that are designed to engage patients and family caregivers in successfully     managing COPD in 'real-world' settings. Both strategies aim to advance patient understanding     of COPD, its treatment options, and self-care tasks; support them in coping with the disease;     and enable them to adopt a variety of positive behaviors, including adherence to treatment     plans, smoking cessation, joining pulmonary rehabilitation programs, and assuming an active,     healthy lifestyle. One strategy relies on the healthcare professional (HCP) as the primary     communicator about COPD self-management (HCP arm), whereas the other uses a dual approach     that involves both healthcare professionals and peer mentors delivering such communication     (HCP plus Peer arm). Peer mentors are COPD patients and caregivers who have successfully     managed COPD and have received foundational training on peer mentoring. Specifically, the     study aims are to : 1) Conduct a randomized controlled trial in which the 'HCP' and 'HCP plus     Peer' strategies are tested in 'real-world' healthcare settings; 2) compare the impact of     these strategies on patient satisfaction, experience, activation, self- efficacy, self-care     behavior, health status, quality of life, use of Emergency Department (ED) and hospital     services, and survival; and, 3) compare the impact of these strategies on caregiver     satisfaction, experience, self-efficacy, stress, and coping skills.   "
30140|NCT02891187|"     The OPTIONs study is a randomized controlled, non-inferiority study to evaluate postoperative     care using outpatient clinic visits versus telephone calls for women undergoing surgery for     pelvic floor disorders. The primary outcome is patient satisfaction using the     Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire     provided by the Agency for Healthcare Research and Quality (AHRQ). Secondary outcomes include     safety and cost analysis for patients' direct and indirect medical costs. Women who speak and     understand either English or Spanish and planning to undergo an elective surgery for a pelvic     disorder will be recruited. Baseline demographics, satisfaction, and cost analysis     questionnaires will be acquired pre-operatively. Randomization will be assigned at the time     of discharge from the hospital. Patients will either have scheduled clinic visits at 1-2     weeks, 6 weeks, and 3 months or telephone calls by a registered nurse at these same     intervals. Questionnaires will be completed at 3 months for satisfaction and cost analysis.   "
30141|NCT02891174|"     To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in     women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).   "
30142|NCT02891161|"     This is an open label, multi-institutional, single arm study of a phase Ib study, followed by     a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial cancer     (UC). No randomization or blinding is involved.   "
30143|NCT02891148|"     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single     rising doses of BI 690517   "
30144|NCT02891135|"     In its 2015 revision of the global guidelines for HIV care and treatment, the World Health     Organization called for initiating lifelong antiretroviral treatment (ART) for all patients     testing positive for HIV, regardless of CD4 cell count. As countries adopt the new     recommendation, known as treat all, millions of additional patients are becoming eligible     for ART worldwide. In sub-Saharan Africa, where most of these patients are located, studies     continue to document high losses of treatment-eligible patients from care before they receive     their first dose of antiretroviral medications. Among facility-level reasons for these losses     are treatment initiation protocols that require multiple clinic visits and long waiting times     before a patient who tests positive for HIV is dispensed an initial supply of medications.     Simpler, more efficient, accelerated algorithms for ART initiation will be needed if treat     all is to realize the benefits expected.      Experts have proposed a simplified clinical algorithm to screen patients for eligibility for     immediate ART initiation at a patient's first clinic visit, without the use of point-of-care     laboratory test technologies. The Simplified Algorithm for Treatment Eligibility (SLATE) uses     four screens to assess whether a patient is eligible for same-day treatment initiation: i)     symptom report, ii) medical history, iii) brief physical examination; and iv) readiness     assessment. SLATE is a pragmatic, individually randomized evaluation to determine the     effectiveness of the algorithm in increasing ART initiation among non-pregnant adult     patients. Approximately 960 HIV-infected adult patients not yet on ART will be enrolled     during a routine clinic visit and randomized to receive the intervention or standard care.     Patients in the intervention arm will be administered the SLATE screens; those found eligible     under the algorithm will be offered immediate treatment initiation, while those who are not     eligible will be referred for standard clinic care. Patients in the standard arm will be     referred for ART initiation under standard clinic procedures. All care after the initial     visit will be by the clinic under standard of care. If successful, SLATE will offer a     standardized approach to collecting and interpreting a minimum set of patient data that will     avoid delaying treatment initiation for the majority of patients who are eligible for     immediate ART, while deferring initiation in the minority who should not start immediately.   "
30145|NCT02891122|"     This study aims to determine if prolonged fasting represents an independent risk factor for     hypotension during induction of general anesthesia in the elderly.   "
30146|NCT02891109|"     The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells     produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells,     are known to control other cells. Their action in chronic immune thrombopenia is actually     unknown.   "
30147|NCT02891096|"     The investigators conducting this study to investigate the relation between the respiratory     muscle strength and respiratory complications. To understand more about respiratory     complications the influence of different factors (such as in- and expiratory muscle strength,     lung function parameters, physical activity, smoking, medications,…) on respiratory     complications (such as pneumonia) will be investigated.   "
30192|NCT02890511|"     A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose     and recommended dose for phase II trial in patients with advanced solid cancer and explore     efficacy of DHP107 in patients with gastric cancer   "
30193|NCT02890498|"     Retrospective analysis of vaginal microbiota in the post-operative course of patient operated     for genital prolapse with vaginal mesh with or without mesh related complication   "
30391|NCT02887924|"     Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group,     application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards     in preterm infants at high risk for RDS would reduce the need for intubation and mechanical     ventilation in early period and ultimately will improve respiratory outcomes.   "
30148|NCT02891083|"     Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after     radical resection still carries the risk of recurrence after complete surgical resection,     especially in some high-risk patients. There are still lack of knowledge on postoperative     treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of     recurrence is associated with the location and cell differentiation of primary tumor, as well     as the presence of lymphovascular invasion. This project is designed to study the efficacy of     adjuvant therapies for at patients with pN0 ESCC and above mentioned risk factors of     recurrence after radical surgery. We aim to compare the differences among adjuvant     chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective randomized     controlled trial. There has been no similar studies in esophageal cancer previously reported     with similar design. The results of this study is expected to have a high clinical relevance.   "
30149|NCT02891070|"     The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for     use as an adjunct to sutured dural repair in cranial surgery.   "
30150|NCT02891057|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
30151|NCT02891044|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
30152|NCT02891031|"     The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as     Somagh on serum uric acid levels.   "
30153|NCT02891018|"     Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter     Vasoguard TM in treatment of in-stent restenosis.      Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM     Control group: paclitaxel release coronary balloon catheter SeQuent Please   "
30154|NCT02891005|"     Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter     VasoguardTM in treatment of small vessel lesion.      Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM)     Control group: common balloon catheter (Maverick2)   "
30156|NCT02890979|"     This pilot clinical trial studies how well a swallowable sponge cell sampling device and next     generation sequencing work in detecting esophageal cancer in patients with low or high grade     dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in     abnormal esophageal cells using a swallowable sponge cell sampling device and next generation     sequencing may improve diagnosis and treatment of esophageal cancer.   "
30157|NCT02890966|"     The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic     properties of multiple dose adminstration of SHR4640 in healthy volunteers.   "
30158|NCT02890953|"     The objective of this study is to evaluate the efficacy and safety of a single     intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage     (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control     group.   "
30159|NCT02890940|"     The goal of this study is to explore whether facial expression changes in visual portraits     correlate with Quality of Life (QOL) questionnaire responses before and after pet therapy     sessions and to compare scores of QOL questionnaires before and after pet therapy.   "
30160|NCT02890927|"     The primary objective of the evaluation study is to determine if geriatric co-management is     superior to standard of care in preventing functional decline in older patients admitted for     acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology     units of the University Hospitals Leuven.   "
30161|NCT02890914|"     Obstetrics and gynecology residents are deemed to be proficient in transvaginal ultrasound     (TVUS) upon graduation from an accredited program, although TVUS education in residency is     not standardized. The objective of this study is to assess for improvement in transvaginal     ultrasound knowledge among residents after viewing an educational DVD.   "
30162|NCT02890901|"     The determinants associated with severe outcome and death from Escherichia coli bloodstream     infections (BSI) remain poorly understood. The epidemiology of E. coli BSI has recently     changed dramatically with the global emergence of multiresistant strains producing     extended-spectrum ß-lactamases (ESBL). Outcome is worse in case of ESBL-E. coli, which may be     due to the intrinsic virulence of ESBL-E. coli or to a delayed adequate empirical antibiotic     therapy because of multiresistance. Predicting the severity of an infection as soon as the     initial clinical assessment is of major importance to provide the best care, while limiting     unnecessary hospitalizations and costs. Yet, no simple clinical score exists to predict the     severity of E. coli infections.      In a translational approach, the investigators will include during a maximum of one year 500     adults with E. coli BSI hospitalized in 7 hospitals in the Paris area, France. Precise     clinical data will be collected at inclusion and 28 days after inclusion or upon patient's     discharge (if before day 28). The primary endpoint of the study is death from E. coli BSI at     day 28.      The first aim is to determine risk-factors for death at day 28, including clinical and     bacteriological factors (determined by WGS) in the era of the global emergence of ESBL     producing E. coli. The second aim is to determine virulence characteristics of ESBL strains     both at the genome and phenotypic level thanks to a mouse model of septicaemia, and compare     them to the clinical data. The third aim, will establish and evaluate a simple clinical     severity score (named COLISCORE), in order to help clinician evaluate patients' severity upon     initial clinical evaluation and particularly to detect patients at risk of severe outcome.     The ultimate goal of this work is to have a clinical impact on patients' management, by     understanding the determinants of patient severity due to E. coli BSI in the context of     current major epidemiological changes.   "
30163|NCT02890888|"     Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.   "
30164|NCT02890875|"     Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated     bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock     therapy for CLABSI prophylaxis in adult patients on PN.   "
30165|NCT02890862|"     Development of reliable and objective evaluation methods is required for natural     upper-extremity tasks. Three-dimensional imaging measurement techniques are a powerful tool     for quantitative assessment of multijoint movements.   "
30166|NCT02890849|"     The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has     an important role in guiding for the treatment of immune detection point. At the same     time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the     information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple,     rapid, non-invasive means of detection. The project is planned to explore the consistency     analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to     detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the     expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures     design information. Thus exploring the consistency analysis of PD-L1 expression level     detected in tissues and pExo,guiding clinical practice of radiotherapy combining with     immunotherapy.   "
30167|NCT02890836|"     Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat     hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes.     Second, to explore the prevalence of preeclampsia and preterm delivery in women with     pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c)     normal blood pressure before entering the third trimester of pregnancy. Third, to explore the     influence of lifestyle, gestational weight gain and mental well-being on confirmed     hypertension and preeclampsia in pregnant women with diabetes.      Design: A prospective multicentre observational study where approximately 400 pregnant women     with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP     for three days three times during pregnancy as well as when the routinely measured office BP     exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and     home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80     mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive     treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat     hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the     prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of     antihypertensive treatment including impaired fetal haemodynamics and lower infant birth     weight will be recorded. The women will complete food diaries and questionnaires on lifestyle     and mental health three times in pregnancy in order to evaluate the influence of these     parameters on hypertension and preeclampsia.   "
30168|NCT02890823|"     To characterize the effect of three different doses of vitamin D3 supplementation on serum     25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing     antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic     drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D     among Thai patients with epilepsy.   "
30169|NCT02890810|"     In this placebo controlled, patient and assessor blinded clinical trial, the investigators     will administer electroacupuncture vs sham electroacupuncture to patients suffering from     chronic low back pain, and monitor their symptoms as well as collecting objective outcome     measures. The investigators objective is to identify predictors of pain reduction and     functional improvement with electroacupuncture vs placebo.   "
30170|NCT02890797|"     Assessment of thoracic echography for pleuroparenchymatous anomaly diagnosis complicating     bronchiolitis. Assessment has performed by radiographic exam.   "
30171|NCT02890784|"     Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve     disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase     Inhibitors (≥2nd line) (DasaHIT Trial (Dasatinib Holiday for Improved Tolerability))   "
30172|NCT02890771|"     Periodontal disease is considered as inflammatory, multifactorial, and threshold disease     accompanied by destruction of periodontium and eventually the loss of natural teeth.     Periodontal disease is highly prevalent dental disease especially, in developing and     underdeveloped countries affecting more or less 80% of the population. For the prevention of     this highly prevalent dental affliction, still no effective and practical preventive measures     are available which can reduce its high prevalence rate though, lot of research work is going     on.   "
30173|NCT02890758|"     The purpose of this study is to find the number of natural killer (NK) cells from non-HLA     matched donors that can be safely infused into patients with cancer. NK cells are a form of     lymphocytes that defend against cancer cells. NK cells in cancer patients do not work well to     fight cancer. In this study, the NK cells are being donated by healthy individuals without     cancer who are not matched by human leukocyte antigen (HLA) genes to patients. After     receiving these NK cells, patients may also be given a drug called ALT803. ALT803 is a     protein that keeps NK cells alive, helps them grow in number and supports their     cancer-fighting characteristics. HLA-unmatched NK cell infusion is investigational     (experimental) because the process has not approved by the Food and Drug Administration     (FDA).   "
30174|NCT02890745|"     The purpose of this study is to investigate the effect of empagliflozin on oxidative stress     in patients with type 2 diabetes. The association is examined by comparing the difference in     oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared     to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each     treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are     measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and     8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment     with placebo. The results will be published in a peer-review journal.   "
30175|NCT02890732|"     This project will benefit from the results of the concept study conducted from July to     October 2014 from groups of coronary patients. This first study will help to develop the     precise contours of Appet HEART application for the production of the prototype version used     in the clinical feasibility study.      The objectives of the feasibility study are:        1. assess the rate of use of the application        2. to determine the ideal target population of the application        3. to evaluate the effectiveness of the application        4. to measure the risks and potential limitations of its use        5. to determine the medical and economic impact of this application   "
30176|NCT02890719|"     Pilot, single center, open-label study to evaluate the efficacy and tolerability of     Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant     recipients with hepatitis C recurrence.   "
30177|NCT02890706|"     Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for     patients with suspected with pulmonary embolism.   "
30194|NCT02890485|"     This study is testing the effectiveness of dry needling for pain management and on muscle     strength and leg function for those with knee pain. Dry needling consists of small,     monofilament needles that are administered directly into the tissue and manipulated to make     the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal     muscle and connective tissue to help diminish pain, reduce impairments of body structure and     restore function.   "
30195|NCT02890472|"     22q11.2 microdeletion seems the prenatally under-diagnosed . Indeed , there is a mismatch     between the series on the heart rate of 22q11.2 antenatal 84% against 30% in the adult series     despite a perinatal mortality of 16% suggesting opportunities for improvement in the prenatal     diagnosis of fetus with a microdeletion 22q11.2 , especially without heart disease   "
30178|NCT02890693|"     MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional     interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and     mental health of women with GDM and their offspring.      Primary objective of MySweetHeart Trial:      To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial     intervention in women with GDM to improve 1) their metabolic health (decrease in maternal     weight between study inclusion after GDM diagnosis and at 1 yr postpartum) and 2) their     mental health (decrease in maternal symptoms of depression during the same time period).      Secondary objective of MySweetHeart Trial:      To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial     intervention to improve other cardio-metabolic and mental health markers in women with GDM     and their offspring.      MySweetHeart trial is linked to MySweetHeart Cohort, an observational cohort study that     assesses the effect of GDM on offspring cardiovascular health early in life. The principal     investigators of the cohort are Nicole Sekarski and Arnaud Chiolero (University Hospital     Lausanne, Switzerland). Their primary objective is to assess the effect of GDM on the     surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and     subclinical atherosclerosis) and the secondary objective is to assess the effect of GDM on     the cardiovascular structure and function during the fetal period and neonatal adverse     cardiovascular risk factors.   "
30179|NCT02890680|"     The purpose of this study is to evaluate the bone regeneration after impacted third molar     surgery on split mouth design using platelet-rich fibrin.   "
30180|NCT02890667|"     This study is a population based observational study conducted on the French administrative     databases to estimate cancer incidence in 2012 by using the ECHANTILLON GENERALISTE DES     BENEFICIAIRES (EGB, a 1/97th dynamic random sample of the SNIIRAM).      The EGB database contains anonymous and prospectively recorded data about all beneficiaries'     medical reimbursements. Many algorithm definitions are defined to estimate the incident rate     of cancer in 2012 from the EGB database. The incidence rates obtained by each algorithm     definition are compared to national incidence rates by indirect age and sex standardization.     National incidence rates are obtained from FRANCE CANCER INCIDENCE ET MORTALITE (FRANCIM):     the French network of cancer registries.   "
30250|NCT02889757|"     Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by     supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However,     there are few published data and large sample sizes regarding the protective effect of NAC     against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge.      Therefore, the investigators designed a clinical trial with the aim to see whether NAC could     protect against anti-TB drug-induced hepatotoxicity (DIH)   "
30181|NCT02890654|"     Around the scoliosis surgery, the pain (pre or post operative, physical, psychological,     fantasy or real) is a major concern for adolescents and their families. She is also a key     concern of caregivers, both its assessment and management is complex. this pain involved     predominantly in the quality of life of these teenagers today who will become the adults of     tomorrow.      To date in France, no study aims to describe and evaluate the effect of a multidisciplinary     approach and its impact on the quality of life of these young people made.      The present study wish to prevent, anticipate and limit the short, medium and long-term     morbidity. Focus will be on pain and its management, on preparing for surgery,     hospitalization, follow-up after surgery, rehabilitation until recovery.      Help teens reclaim their bodies after the changes caused by the intervention is a major     issue.      This study believe that support good quality, adapted to patient needs will limit operating     and postoperative pain in the medium and long term.      Medical team developed special attention around the teenagers that are operated for scoliosis     (teen groups and parent groups, interview before the operation and counseling, physiotherapy     support ...).      The present study would systematize data collections in order to have a comprehensive and     accurate assessment of the care.      The qualitative research will focus on the multidisciplinary care in an effort to evaluate     the whole course of these teenagers, their experience and to identify efforts to put in place     to optimize the current care.   "
30182|NCT02890641|"     Genetic abnormalities in focal epilepsies are well known. A novel gene (DEPDC5) was     identified, associated with various genotypes of epilepsies. Recently, DEPDC5 mutations were     identified also inside focal cortical dysplasias. This could suggest that a somatic mutation     in DEPDC5 could be responsible for the cortical dysplasia. The study aims to identify various     genetic mutations responsible for drug-resistant focal epilepsies due to Focal cortical     dysplasia in children undergoing surgery for epilepsies due to focal cortical dysplasias in     Rothschild Foundation, Paris. Patients and their parents will be recruited to identify     genetic abnormalities both in lymphocytic and cortical DNA.   "
30183|NCT02890628|"     This study is to explore perceptions, experiences, beliefs and knowledge around teenage     pregnancy, motherhood, sexual and reproductive health, family planning and support structures     adolescent refugees and migrants and to identify demographic, social and medical     characteristics of study participants.   "
30196|NCT02890459|"     The success of combination HIV prevention efforts, including HIV treatment as prevention,     hinges on universal, routine HIV testing with effective treatment after HIV diagnosis. The     proposed study will evaluate the comparative effectiveness and sustainability of innovative     incentive strategies, informed directly by behavioral economics and decision psychology, to     promote HIV testing among men and HIV treatment among HIV-infected adults in rural Uganda.   "
30197|NCT02890446|"     This study compares the effects of an internal versus an external focus of attention on motor     training of the affected arm for individuals with stroke. Participants were randomly assigned     to either the internal or external focus treatment groups and received 12 sessions of arm     training.   "
30198|NCT02890433|"     The national recommendations promote the applying of the Contact Additional Precautions (CAP)     with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR)     bacteria. However, that could entail more costs and a reduction of quality of the patient     care.   "
30199|NCT02890420|"     This study permit to evaluate the characteristics of children in third year of preschool,     during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual     medical visit.The aim of the study is to describe the nutritional status of children     under-six years of age: underweight, overweight, and obesity considering the sex. .   "
30184|NCT02890615|"     Depressive symptoms are common in cancer survivors; 15% or more of cancer patients, even 1     year after diagnosis, experience depressive symptoms that can have a negative impact on their     quality of life. Canadian care guidelines for cancer survivors recommend supporting the     active engagement of survivors in their self-care.      This study is an evaluation of the effect of a depression self-care program which includes a     self-care toolkit and support in the form of regular telephone calls from a self-care coach.      The toolkit contains tools that help cancer survivors:        1. Learn new information to better understand depression. This can help people feel that          they are not alone, and that their experience is not abnormal. Better understanding a          condition also helps people feel more confident in their communications with health care          professionals and can make it easier to share their experience with family and friends.        2. Learn and practice new coping skills. This can help people feel confident that they can          engage in the behaviours that have been shown to be beneficial for mood, e.g.          restructuring thoughts, problem solving, and planning pleasant activities.      People eligible for the study are aged 18 and over, 1-10 years post-diagnosis, have completed     primary cancer treatment (chemotherapy, radiation therapy or surgery) for any type of cancer,     and have moderate depressive symptoms (as measured by a Patient Health Questionnaire (PHQ-9)     score of 8-19). Recruitment will be conducted at cancer care centres in Montreal and at the     Princess Margaret Cancer Centre in Toronto, and via community cancer support groups in Quebec     and Ontario. Each participant enrolled in the study will receive the self-care toolkit (half     will receive the toolkit and support calls at the start of the study, and half will receive     the toolkit at the end), and will be followed for 6 months.      This proposed self-care program is innovative in its approach to the treatment of depression     and has the potential to significantly improve the quality of life for Canadian cancer     survivors with persistent depressive symptoms. The results of the study will determine     whether the supported depression self-care program for cancer survivors is effective. The     program is designed to be sustainable and widely applicable as it involves minimal costs, and     the coaching can be delivered by telephone by volunteers in hospital and community settings.     Investigators will work with clinical stakeholders and patient representatives to ensure that     deliverables are relevant to the target population. Specific deliverables (in both French and     English) include: a toolkit with a manual describing its use; a manual detailing coaching     procedures; reports for decision makers and community cancer care groups; and short summaries     for stakeholder groups.   "
30186|NCT02890589|"     To assess strut coverage in patients presenting an acute myocardial infarction and treated     either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel     group design.   "
30187|NCT02890576|"     The number of patients with cochlear implants increases every year, constituting an active     queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380     adult patients). The number of approved cochlear implant centers is limited by guardianships,     and corresponds to the Hospitals University. It is not possible to create networks of     correspondents. Teams of implantation centers must meet the needs of new patients and ensure     continuity of care for patients already implanted: speech therapy monitoring, adjustment and     rehabilitation.      In case of malfunction of the implant, patients use in first-line reference center. The     increasing number of patients leads to a lack of specialized teams that can not meet the     demands of patients in a timely manner, while continuing to provide support for new patients.     It is therefore necessary to find solutions to improve the service provided to patients who     received a cochlear implant system to respond quickly and effectively to the request of     troubled patients, while optimizing the workload of the teams . The introduction of a     telemedicine platform is expected to achieve these goals, distinguishing minor malfunctions,     not requiring a consultation in a center, and the most complex situations requiring     consultation in a center.   "
30188|NCT02890563|"     Study purpose is to research whether compression therapy is beneficial after truncal vein     RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be     randomised to either no compression group (Group I) or compression group (Group II)   "
30221|NCT02890134|"     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known     today are a group of chronic inflammatory conditions with autoimmune aetiology with few     treatment options and difficult diagnosis.Brest team contribute to performe a new     classification of the following systemic autoimmune diseases in a European Union's Seventh     Framework Programme. The aim of this research consiteis to reclassify the individuals     affected by SADs into molecular clusters instead of clinical entities through the     determination of molecular profiles using several Omics techniques.   "
30189|NCT02890550|"     The aim of the study is to characterize the clinical manifestations of ALMS within the     ciliopathies to prevent complications and determine preventive and therapeutic targets.      The investigators believe that the clinical consequences of mutations in the gene result     ALMS1 unprecedented protests and the ALMS study should help to be informed, not only about     the understanding and decision support other ciliopathies, but also about some common     diseases, as some physiopathogenic roads could be common; the rare disease being exacerbated     a model of the channel concerned. Secondarily, the clinical data generated by this project     will also be used as part of basic research (eg comparison with results in animal models, use     of human cells for in vitro studies or transcriptomic ....) (which will be a secondary     upgrading to this work).   "
30190|NCT02890537|"     Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of     the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.     Core decompression is currently the treatment of choice for early stage osteonecrosis of the     femoral head. This method consists in decompressing the rigid intra-osseous chamber to     promote revascularization, thus halting progression of the disease and stimulating repair.     Still this treatment remains highly controversial, since the success rates of the first     studies have not been repeated.      The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated.     Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures,     microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells     recruitment.      Three studies have indicated the potential clinical benefits of cell-based approaches for the     treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004).     This is on the basis of these observations that a proprietary population of autologous     osteoblastic cells (PREOB®) has been developed.      This Phase 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment     of early stage osteonecrosis of the femoral head. The primary goal of this study was to     investigate the safety and efficacy of the implantation of the investigational product PREOB®     (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow     concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a     follow-up period of up to 5 years.   "
30191|NCT02890524|"     The investigators will investigate whether the night guard can suppress the development of     recurrent aphthous stomatitis (RAS). The investigators will record the patients' oral     condition for 60 days before and after intervention with the night guard made of     Ethylene-Vinyl Acetate copolymer (EVA). The patients' saliva will be analyzed for measurement     of inflammatory cytokines or oxidative stress.   "
30200|NCT02890407|"     The association study will compare the allele frequencies of polymorphisms of a single     nucleotide (SNP) in the population of individuals with aortic stenosis compared to a control     population.      Patients will be included only if they are suffering from a typical form of tight and     surgical tricuspid aortic stenosis. Patients will therefore only included if they are     suffering from aortic stenosis, the surface is less than 1 cm² and if histological analysis     or failing intraoperative findings of the surgeon showed a tricuspid aortic stenosis.   "
30222|NCT02890121|"     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known     today are a group of chronic inflammatory conditions with autoimmune aetiology with few     treatment options and difficult diagnosis.Brest team contribute to perform a new     classification of the following systemic autoimmune diseases in a European Union's Seventh     Framework Programme. The aim of this research is to reclassify the individuals affected by     SADs into molecular clusters instead of clinical entities through the determination of     molecular profiles using several Omics techniques.   "
30201|NCT02890394|"     The project is based on checking the effectiveness of the technique of suboccipital     inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves     the placement of the hands of the physiotherapist under the patient's head so that fingers     can feel the spinous processes of the cervical vertebrae. Then the fingers slowly leads     upward to contact the occipital condyles. At this point the investigator should gently move     your fingers down, finding the space between the condyles and the spinous process of the     axis. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull. In     this technique the investigator would be carrying out the relaxation of the suboccipital     muscles: lower rectus capitis posterior, superior oblique head straight back and head higher.     It is a technique used very often but without knowledge about the time needed for     implementation. In several studies that have used the technique it has been maintained for     2.4 or 10 minutes without agreeing how long is necessary. The study will consist of three     groups formed by patients with mechanical neck pain that they applied the technique two, four     or ten minutes and a control group of patients with mechanical neck pain. The four groups     were measured before and after treatment the pain threshold to pressure by algometer and     conduct the test repositioning of the head to show any changes after application of the     technique.   "
30202|NCT02890381|"     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in     RSV-seronegative infants 6 to 24 months of age.      This study is a companion study to CIR 312.   "
30203|NCT02890368|"     This is a multicenter, open-label, phase 1 study that is being done to test intratumoral     injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible     solid tumors or mycosis fungoides.      The study will be performed in two different parts. Part 1 is the Dose Escalation phase and     Part 2 is the Dose Expansion phase.      The purpose of this study is to characterize the safety profile of TTI-621 and to determine     the optimal dose and delivery schedule of TTI-621.   "
30205|NCT02890342|"     Background:      People s bodies need to break down food into the chemicals. These chemicals are used for     energy and growth. Some people cannot process all chemicals very well. Too much of some     chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People     with PA can have problems with growth, learning heart, abdomen, and other organs. Researchers     want to better understand how these problems happen.      Objective:      To learn more about propionic acidemia and the genes that might contribute to it.      Eligibility:      People at least 2 years old with PA who can travel to the clinic      Some unaffected family members      Design:      Participants will have a 3 to 5-day hospital visit every year or every few years. Family     members may have just 1 visit.      During the family member visit, they may have:      Medical history      Physical exam      Samples of blood and urine      Questions about diet and a food diary      Doctors and nurses may do additional studies:      Samples of saliva, skin and stool      Fluid from a gastronomy tube, if participants have one      Dental and eye evaluations      A kidney test - a small amount of dye will be injected and blood will be collected.      Consultations with specialists      A test of calories needed at rest. A clear plastic tent is placed over the participant to     measure breathing.      Stable isotope study. Participants will take a nonradioactive substance then blow into a bag.      Photos taken of the face and body with underwear on      Ultrasound of the abdomen      Heart tests      Hand x-ray      Brain scan      Participants may have other tests if study doctors recommend them. They will get the results     of standard medical tests and genetic tests.   "
30206|NCT02890329|"     This phase I trial studies the side effects and best dose of ipilimumab when given together     with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia     that has returned after a period of improvement or does not respond to treatment. Monoclonal     antibodies, such as ipilimumab, may block cancer growth in different ways by targeting     certain cells. Drugs used in chemotherapy, such as decitabine, work in different ways to stop     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or     by stopping them from spreading. Giving ipilimumab and decitabine may work better in treating     patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.   "
30207|NCT02890316|"     To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive     and emotional functions.   "
30208|NCT02890303|"     This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies     during cataract surgery with phacoemulsification.   "
30209|NCT02890290|"     The purpose of this study is to determine whether a marine protein hydrolysate given as a     supplement to meals with low protein content can prevent age related loss of muscle mass and     improve physical function in frail elderly. The study will recruit elderly living at home     with help from municipal health care services, and a secondary goal of the study is to     describe food habits, seafood intake and nutritional status in this group of patients.   "
30223|NCT02890108|"     This study will compare the effect of acute consumption of two carbonated drinks, sweetened     with sugar or with non-caloric sweeteners, over the insulin response of healthy adults who     normally consumed foods or drinks that contain non-caloric sweeteners   "
30251|NCT02889744|"     The investigators hypothesize that        1. if decrease in SctO2 level is caused by the degree of hypothermia, SctO2 level in the          33-TH may be lower than that in the 36-TH group.        2. if decrease in SctO2 level is not caused by the degree of hypothermia but caused by          brain injury, SctO2 level may be associated with only the prognosis of cardiac arrest          victims regardless of core temperatures.      The primary objective of this study is to compare the 72-hour changes in SctO2 level between     the 36-TH and 33-TH groups in cardiac arrest victims.   "
30210|NCT02890277|"     Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic     diseases shown as female genital skin and mucosal tissue degeneration and pigmentation     change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal     skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug     or surgical treatments. However, the effect is not good enough, but the diseases often recur     and severely affect patients' quality of life. In this study, the investigators combined the     technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang     Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to     treat. The data from colposcopy and biopsy pathology were collected before and after     treatment to create the objective identifying degree of the disease by with grading methods     and evaluate the treatment effect. At the meantime, the standardized treatment procedure,     methods and efficacy criterion were all stipulated to achieve satisfactory results, which     could be used to clinical treatments. So far, the investigators have not seen similar study     reported internationally.   "
30211|NCT02890264|"     The main purpose for holding this survey is epidemiological surveillance, it must provide the     indicators that contribute to the evaluation of the plan improvement of the quality of life     in chronic diseases and monitoring the goal of 81 health law public in August 2004. This     survey is intended to be renewed during the implementation period of the public health law to     provide plan monitoring indicators.      The main objective is : To describe the quality of life of patients with major end-stage     renal disease treated with dialysis method for at least one year.      The seconds objectives are :        -  To contribute to the knowledge of the key determinants of the quality of life among          chronic renal failure patients.        -  To study the influence on way of giving a questionnaire about assessment of level of          quality of life   "
30212|NCT02890251|"     The purpose is to describe the level of visual maturation of premature newborns at term     equivalent age.      The secondary purpose is to determine factors associated to an altered level of visual     maturation, through an exploratory approach.   "
30213|NCT02890238|"     100 women with infertility classified into 2 groups.      Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2     times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day     of the same cycle orally 3 times/day.      Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2     times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same     cycle orally 3 times/day.   "
30214|NCT02890225|"     The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to     eliminate stone completely,previous studies have proved that the application of External     Physical Vibration Lithecbole(EPVL) treatment can effectively promote the discharge of renal     residual stones after RIRS, improve the stone free rate(SFR) .However, when is the the best     time of performing EPVL , and with the least complication, there is still no     conclusion.Therefore, researchers purpose to evaluate the effectiveness of EPVL in treatment     of residual fragments in different time (3 days ,7 days and 14 days) after RIRS by     prospective study of clinical trial, which will determine the best time for performing EPVL     treatment.   "
30215|NCT02890212|"     The main goals of antidepressant treatments are to achieve remission of depressive episodes     and prevent recurrences. However, clinical trials designed to approve antidepressants targets     a response rate of at least 50%, which is considered partially effective. Therefore, there is     a need for new treatment strategies, including augmentation with other substances such as     lithium. This research aims to verify through a pilot study, the effect of selenium as an     augmentation treatment for sertraline-resistant major depression. This clinical trial was     designed to be a randomized, placebo-controlled, double-blind trial evaluating the effect of     selenium or placebo in subjects diagnosed with major depression who have not responded to     treatment with sertraline   "
30216|NCT02890199|"     During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into     the vaginal tissues to help with tissue dissection. It is common that anesthetic medication     is mixed into this fluid to help with pain control after surgery. Usually the pain medication     injected is short-acting. In this study the investigators plan to compare the usual     short-acting injected pain medication with a long-acting injected pain medication to evaluate     whether this improves pain control after surgery.      One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous     ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study     participants will be randomized to one of two study groups:        1. Lidocaine group (short-acting medication).        2. Liposomal bupivacaine group (long-acting medication)      Information will be collected on study participants, including: demographics, procedure data,     and post-operative information. The primary outcome of this study is determine if use of     long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to     less post-operative pain compared to short-acting local anesthesia.      Secondary outcomes include:        1. post-operative opioid medication use        2. return to baseline pain status        3. post-operative time to first bowel movement        4. post-operative antiemetic use (nausea medication)        5. results of voiding trial after surgery        6. patient satisfaction with pain control   "
30217|NCT02890186|"     To investigate the application of closed target-controlled infusion(TCI) of propofol and     remifentanil guided by Narcotrend index in the anterior cervical decompression and fusion     with internal fixation surgery.   "
30218|NCT02890173|"     To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients     with essential hypertension.   "
30219|NCT02890160|"     The FUTURE-II study is a confirmative clinical trial for Sirolimus Target Eluting     Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has     been preliminary confirmed in a small-scale First-in-Man clinical trial.   "
30220|NCT02890147|"     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known     today are a group of chronic inflammatory conditions with autoimmune aetiology with few     treatment options and difficult diagnosis.Brest team contribute to perform a new     classification of the following systemic autoimmune diseases in a European Union's Seventh     Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort to     compare with systemic autoimmune diseases cohort into molecular clusters instead of clinical     entities through the determination of molecular profiles using several Omics techniques.   "
30224|NCT02890095|"     Exposure to certain classes of chemical contaminants, including certain persistent organic     pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that     lead to increase incidence of breast cancer in the Western world .      However, the causal role of POPs in the onset of breast cancer remains nowadays unproven.     Preliminary epidemiological studies on the impact of these environmental factors in breast     cancer etiology have ignored the critical periods of exposure. Similarly, they have     considered a limited number of pollutants (not including possible joint or synergistic     effects between individual compounds) and did not distinguish the different breast cancer     subtypes may have different etiologies or even of genetic susceptibility factors (POP     polymorphism of detoxification enzymes).      Thus, POPCASE study examines the association between the presence of breast cancer and the     levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in     particular using spectrometric methods developed by the team LABERCA (Nantes, France). These     internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame     retardants) will be measured both quantitatively (tissue concentrations) and qualitative     (relative proportions of different pollutants sought).   "
30225|NCT02890082|"     The rates of patients with spontaneous pregnancies reported after breast cancer is between 3     and 7%, particularly because of these treatments.      Therefore, it is essential to anticipate this problem by proposing the use of fertility     preservation techniques for these young patients prior to any gonadotoxic treatment.      PRESAGE study offers to patients fewer than 40, to preserve their fertility before     neoadjuvant or adjuvant chemotherapy for invasive breast cancer.      The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order     not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen     followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or     embryonic.      This procedure is already done in many countries, and by some French teams, by combining     tamoxifen or letrozole to the classic gonadotropin stimulation.   "
30226|NCT02890069|"     The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents     with immunomodulatory activity to identify the doses and schedule for combination therapy and     to preliminarily assess the safety, tolerability, pharmacological and clinical activity of     these combinations.   "
30227|NCT02890056|"     The purpose of this study is to determine the efficacy of a community-based behavioral     intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water     consumption among school-aged youth and parents/caregivers. We hypothesize that participants     in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and     increased water intake compared to participants in the comparison site at 2 and 6 months     follow-up.   "
30228|NCT02890043|"     The object of this study was to evaluate the accuracy and safety of the Tirobot system.   "
30229|NCT02890030|"     The patients enrolled on this new study will serve as an appropriate comparison group     consisting of patients with the diagnosis of germ cell testicular cancer who were cured with     surgical resection and did not receive cisplatin-based chemotherapy with a group of patients     from another study who did receive cisplatin-based chemotherapy.   "
30230|NCT02890017|"     This is a medico-economic study of outpatient surgery paired with a night stay in a     patient-hotel, compared with a conventional hospitalization for three types of urological     surgeries.      The aim is to show that those two strategies are not different in term of adverse effects or     rehospitalization, and that the patient-hotel provide a better quality of life at a reduced     cost, in order to generate savings for the paying agent: the Healthcare insurance.   "
30231|NCT02890004|"     This prospective, observational study aim to identify :        -  Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit        -  The impact of standard therapeutic used (surgery, embolization ; medical treatment of          vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)   "
30232|NCT02889991|"     This study evaluates the deep dry needling technique as a percutaneous technique included in     the professional field of physiotherapy.      The project quantifies a significant limit on the number of local twitch responses necessary     for the favorable treatment of myofascial pain and analyzes the injury degree and/or the     repair of myofascial tissue, with Elastography.   "
30233|NCT02889978|"     GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop     assays to detect cancer early in blood. The purpose of this study is to collect biological     samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors     who do not have a diagnosis of cancer (blood) in order to characterize the population     heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing     cancer from non-cancer.   "
30246|NCT02889809|"     There is a regulatory requirement to evaluate the extent of reduction (if any) of growth     velocity associated with inhaled corticosteroid (ICS) containing products that are to be     administered to children, and to this end there is Food and Drug Administration (FDA)     regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind     (treatment period), parallel group, placebo controlled, multicentre study to assess the     effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth     velocity in prepubertal asthmatic children on a background therapy of open-label montelukast.     This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in     period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50     mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The     purpose of the study is to evaluate the magnitude of effect (with a level of precision) on     growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following     administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU)     and United States (US) regulatory requirements for the evaluation of potential growth     suppression in children.   "
30234|NCT02889965|"     OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in     France. It aims to provide a major epidemiological tool on MS for the scientific community in     France and abroad. This tool must help to answer a large number of questions concerning the     causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness     and safety of therapeutic drugs, the impact of the disease on patients and society, etc.      In December 2015, it has already included more than 54.000 patients. To achieve this goal,     OFSEP's objectives are        -  To maintain and develop the French cohort of patients suffering from MS or related          diseases and syndromes. This means collecting standardized socio-demographic and          clinical data as part of the routine medical follow-up of patients already in the cohort          and recruitment of new patients.        -  To supplement the existing clinical data with standardized and quality biological          samples and MRI scans.        -  To improve the previous data with medical/administrative data from the health insurance          fund databases in particular, in order to get more information on comorbidity, treatment          protocols and the medico-economic aspects of this disease.        -  To use OFSEP infrastructures to facilitate the implementation of specific studies          requiring the collection of additional data or specific patient monitoring processes.        -  To ensure the availability of these data and samples to researchers, health care          authorities and industrial players to enable analysis and thus provide answers to          research questions or public health issues. This availability is only possible after          scientific and regulatory evaluation of the request.        -  To provide regular descriptions of the patient population in the cohort to offer          statistics, targets and up-to-date information on this disease and thus enable a better          approach to the personal, professional and social impacts of the illness, the effects of          basic treatments and the requirements related to the follow-up of this disease in          France.        -  To conduct specific studies on the entire population of patients in the cohort (parent          cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four          nested cohorts have been defined: patients with radiologically isolated syndromes,          patients with clinically isolated syndromes, patients with primary progressive courses          of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum          disorders.   "
30235|NCT02889952|"     This Before-and-after Controlled Study study evaluates the clinical impact of parathyroid     autofluorescence visualization using near infrared light (NIR) during total thyroidectomy     (TT).      It compares two groups of consecutive patients who underwent TT associated or not to lymph     node dissection (LND) with and without intraoperative use of NIR, by the same surgeon.   "
30237|NCT02889926|"     Leg ulcers are defined as wounds lasting for more than a month. They would receive 0.2% of     the population of Western countries. In Europe, the cost per episode of leg ulcers is     estimated at 6650 euros (10 000 euros for a foot ulcer). The cost of treatment of wounds     would be 2 to 4% of the health budget. Infection is the most common complication of chronic     wounds: in most cases, it results in delayed healing, at most, it can result in amputation or     serious general complications Bacterial contamination of ulcers is constant. Over time for     over 25 years, various studies have shown about relatively identical results. The bacteria     are present in over 90% of the etiology of venous leg ulcers. These bacteria are divided into     four most common classes: Staphylococcus aureus, Enterococcus, Streptococcus, Pseudomonas.     The bacterial ecology changes over time. Indeed Staphylococcus aureus appears first, while     the Pseudomonas is associated with ulcers lasting for several months. Anaerobic more     difficult to find, are found in 30% of cases Cohabitation between leg ulcers and bacteria     often without clinical consequence: These are the stages of infection and colonization.      The infection is related to the proliferation of bacteria and their invasion into the skin,     by increasing their virulence (virulence genes acquisition). The increase in the number of     bacteria and the multiplicity of bacterial genera are one reason for the increased virulence     of bacteria. When bacteria proliferate, because the host defenses are inadequate, or because     there is a vascular disease which promotes the proliferation, clinical signs appear   "
30238|NCT02889913|"     Leg ulcers are frequent. There are no epidemiological studies available in France, but     international studies estimate the prevalence between 0.045 and 0.63% of the total     population, prevalence increases with age, reaching 5% of patients over 80 years.     Extrapolating these prevalences in the French population between 28 000 and 395 000 people     are affected in France a leg ulcer.      It is a costly disease. In 2001, a French study conducted among 800 physicians, including     85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was     estimated that the total cost of treatment per patient average was 888 32 euros. This is     truly a public health problem.      Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed).     However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis.     These ulcers rare causes require specific treatments that can often heal. To diagnose, to     perform a skin biopsy. Thus, the general practitioner must know when to put the indication     for biopsy of a leg ulcer.   "
30239|NCT02889900|"     This is an open label, single arm, multi-center study to assess the efficacy and safety of     the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade     serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal     carcinoma patients who have received at least 3 prior lines of chemotherapy and who do not     carry deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)     mutations.   "
30240|NCT02889887|"     The aim of this study is to analyse correlation between the sensory processing and motor     development in preterm infants.   "
30241|NCT02889874|"     This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus     observation following breast conserving surgery and planned endocrine therapy in patients     with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.   "
30242|NCT02889861|"     IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for     eligible patients with advanced melanoma who have previously participated in an IMCgp100     study (parent study).   "
30243|NCT02889848|"     This pilot study evaluates the safety and tolerability of a single injection of collagenase     enzyme directly into a uterine fibroid in subjects already selected for hysterectomy or     myomectomy.      Fibroids contain excessive amounts of collagen and it is possible that digestion of collagen     may be beneficial in reducing pain and bleeding associated with fibroids.      Three subjects will be injected with saline only to evaluate the safety and effectiveness of     the injection method. Additional subjects will then be injected with increasing doses of     study drug.   "
30244|NCT02889835|"     This study will examine the clinical performance of Class II restorations over a three year     period with 3 composite resins - a conventional composite resin, a flowable composite resin     and a bulk placed and cured composite resin.   "
30245|NCT02889822|"     Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and     tolerability of single/multiple-dose administration of different doses of Alprostadil     Liposome for Injection as well as to confirm the safety dose range.   "
30247|NCT02889796|"     The primary objective of this study is to evaluate the effects of filgotinib versus placebo     in adults with active rheumatoid arthritis (RA) who have an inadequate response to     methotrexate (MTX).   "
30252|NCT02889731|"     Background: Suicides by jumping from the high buildings of acute hospitals are dramatic     events which are highly traumatizing to families, staff and fellow pts. In the 10 years     from1995 to 2010 the investigators have counted 10 suicide cases despite extensive measures     taken to predict and avoid them.      The investigators hypothesized that constructive measures at the windows that would render     access more difficult could discourage spontaneous suicidal behaviour and would reduce the     suicide rates.      Intervention: Starting in 6/2004, a 20 mm diameter metal guard-rail (which resists 250kg) was     installed at each window of a 360 bed acute hospital at a height of 113cm, 18cm above the     window parapet with the aim to visually, psychologically and physically discourage potential     suicidal impulses.   "
30253|NCT02889718|"     This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the     effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram,     to maintain the hypnosis level within the recommended limits for general anesthesia. The     analgesic agent is administered in Target-Controlled Infusion = TCI and analgesia evaluated     by pupillometry.      This is a prospective, open, non-controlled, non-randomized, monocentric study. The main     objective is to study the potential contribution of the system in the conduct of anaesthesia,     as decision support, for the administration of the hypnotic agent.      Secondary objectives will include hemodynamic stability, and the average concentrations of     opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.      The study will involve surgical patients scheduled for surgery under general anesthesia for     more than 1 (one) hour.   "
30254|NCT02889705|"     Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular     torticollis (CMT) infants with quantified echotexture and measured thickness during the     treatment course.      Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital.     Participants: Infants with clinical diagnosis of CMT, without any neurological presentation,     cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the     study.      Intervention: All subjects had physiotherapy for at least 3 months. They underwent at least     two times of clinical assessment and ultrasonographic examination (1) for bilateral SCM     muscles during the follow-up period.      End of follow-up: Subjects who still had prominent clinical presentations after physiotherapy     for 6 months or were older than 1 year would receive surgery. Subsided presenting clinical     features determined by the clinician was the other end-point of this investigation.      Main Outcome Measures: The K value, derived from the difference of echo intensities (2)     between the involved and uninvolved SCM muscles on longitudinal sonograms, was used to     represent the severity of muscle fibrosis in CMT infants. Bilateral SCM muscle thickness and     involved-to-uninvolved thickness ratio (Ratio I/U) were also obtained from longitudinal     sonograms. Clinical outcome was also recorded.   "
30255|NCT02889692|"     The investigators performed a randomized, double blind controlled, prospective study method     on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy     maintenance to prolong the efficacy of long-term survival of advanced pulmonary     adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3     years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance     plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a     better efficacy on prolonging progression-free survival time, overall survival, improving     quality of life(QOL) of patients than that of targeted maintenance therapy.   "
30256|NCT02889679|"     The aim of this study is to compare the efficacy of underwater resection (polypectomy) versus     conventional polypectomy techniques for small and large colorectal lesions identified during     colonoscopy.   "
30257|NCT02889666|"     The purpose of this study is to determine if the commonly administered chemotherapeutic     agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid     tumors in clinical oncology, either a single format or given as combinations followed by     surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer     patients.   "
30258|NCT02889653|"     The purpose of this study is to determine the incidence and severity of bleeding     complications in patients with cerebrovascular and cardiovascular diseases treated with oral     antithrombotic therapy.   "
30259|NCT02889640|"     This research aims to examine the extent to which a promising academic     intervention—high-intensity tutoring by SAGA Innovations—that has previously been shown to     significantly improve academic outcomes for disadvantaged Chicago youth can be implemented at     an even greater scale. By taking advantage of the power of random sampling, this study will     allow for observation of the program's effectiveness as if it were running at five times the     proposed scale. In addition, this study will explicitly explore the extent to which there is     a trade-off between effectiveness and scale.   "
30260|NCT02889627|"     Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This     clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation     for epilepsy.   "
30261|NCT02889614|"     Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic     of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic     (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims     to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related     psychiatric disorders.   "
30262|NCT02889601|"     Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients     with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a     quantification and follow-up scale specifically dedicated to patients with FTD in current     clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyper     orality, Negligence and loss of Empathy.   "
30288|NCT02888301|"     This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed     tomography (CT) in imaging patients with cancer before and after treatment with a therapy     that activates the patient's immune system (immunotherapy). PET/CT scans give detailed     pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive     substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly     expressed in activated immune cells, making them light up during PET/CT scans. Doctors also     want to know how 18F-clofarabine is distributed throughout the body before and after     treatment with immunotherapies.   "
30263|NCT02889588|"     Refractive surgery includes interventions to correct refractive errors, using a medical     device such as a laser or an implant (intraocular lenses) or surgical instruments. The study     distinguishes corneal interventions, carried on the surface of the eye, and intraocular     interventions, performed on the lens or in the anterior or posterior chamber of the eye. The     number of procedures in refractive surgery is growing significantly. They seem to offer     satisfactory visual results but a number of issues remains unresolved. In order to get     emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower     orders (ie spherical refractive error and astigmatism). This increases high-order aberrations     (the most common is a bright halo on the edge of the image). The cutting of the flap to the     surface of the cornea in the case of LASIK increases high-order aberrations, which have the     effect of reducing post-surgical visual performance (ie visual acuity and contrast     sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a     post-operative cornea is more complex. It is therefore necessary to limit these post-surgical     aberrations and to identify their possible sources. Indeed, some authors have provided     insight into the effects of some high-order aberrations, but the influence of several factors     characterizing the preoperative eye on refractive surgery are still unknown, such as     pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.   "
30264|NCT02889575|"     Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular     filtration rate decreasing. Acute Tubular Necrosis (ATN) remain the major cause of ARF     involving distress and destruction of tubular cells. This specific typology of ARF may evolve     toward Chronic Renal Failure (CRF) concretizing a major public health issue.      Predict the progression of ARF towards CRF appears essential. The investigators believe that     the PIIINP and urinary NGAL biomarkers may constitute robust biomarkers of progression risk     towards CRF.   "
30265|NCT02889562|"     In this open-label, prospective, randomized pilot study, patients who develop atrial     fibrillation after isolated coronary artery bypass grafting surgery will be identified.     Patients with persistent atrial fibrillation (>12 hours) or recurrent sustained atrial     fibrillation (>2 episodes of atrial fibrillation lasting longer than 30 minutes) will be     candidates for inclusion. Upon meeting study inclusion and exclusion criteria, and after     informed consent, patients will be randomized to either the standard of care (warfarin per     protocol) or apixaban arms of the trial. Routine postoperative care after CABG will occur in     both groups. Upon discharge, anticoagulation in both groups will be managed by the     anticoagulation clinic. Patients will be followed for 30 days after surgery.   "
30266|NCT02889549|"     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used     clinically for the prevention of atherothrombotic events in patients with acute coronary     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been     formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg     daily plus aspirin for ACS patients. However, few East Asian patients have been included in     these trials to assess the use of these drugs. In addition, a growing body of data supported     that East Asian might have different adverse event profiles (thrombophilia and bleeding) and     therapeutic window compared with white subjects. But it is still not clear whether a low     dose of ticagrelor is superior to clopidogrel in diabetic patients with stable coronary     disease.      Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect     endothelial function. ACS patients treated by ticagrelor had a significantly higher increase     in levels of circulating progenitor cells compared to those treated by clopidogrel,     suggesting a benefit on endothelial regeneration that may participate in the pleiotropic     property of the drug. This may prompt the regression of blood vessels and the endothelium     stability. But it is not very clear that the effect of low-dose ticagrelor on vascular     endothelial function in diabetic patients with stable coronary artery disease.      Therefore, the investigators performed this randomized, single-blind clinical trial to     observe the effects of different doses of ticagrelor and standard-dose clopidogrel on     platelet aggregation and endothelial function in diabetic patients with stable coronary     artery disease.   "
30267|NCT02889536|"     A parastomal bulge (PB) is a frequent long-term complication after stoma formation. Most     parastomal bulging occurs within two years of stoma formation but is seen up to 20 years     post-surgery. A bulge may be relatively obvious or extremely difficult to diagnose, and     descriptions of symptoms vary from 'asymptomatic', 'symptomatic' to 'high symptom load'.     Previous studies report that quality of life as well as physical, psychological and social     function are affected in patients with parastomal bulging. However, there is a lack of     knowledge of patients' lived experiences with parastomal bulging. Insight into patients'     experiences of symptoms in relation to parastomal bulging and the impact on everyday life may     help identify issues of importance from the patient perspective. This, in turn, may help     professionals to better understand and support patients with PB, and be of help when     identifying patients' symptoms and determining relevant treatment strategies.   "
30268|NCT02889523|"     Phase I of the study is designed to determine the recommended phase II dose (RP2D) for     tazemetostat in patients treated with R-CHOP 21.      Phase II of the study is designed to determine the safety of tazemetostat in patients treated     with 8 cycles of R-CHOP 21 and to determine the complete response rate according to Cheson     International Working Group (IWG) 2014: Lugano Classification (i.e. Deauville scale 1-3)     after 8 cycles of Epi-RCHOP 21.   "
30269|NCT02889510|"     Type 2 diabetes (T2DM) is related to reduced pulmonary function. As experimental studies with     glucagon-like peptide 1 (GLP-1) have shown an increase in pulmonary surfactant secretion, and     the GLP-1 receptor has been found in significant amounts in the lung, it could be     hypothesized that the treatment with liraglutide (a GL-1 agonist) will improve this reduced     pulmonary function   "
30270|NCT02889497|"     This study evaluates the safety,three batches consistency and immunity duration of the     post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71     months.This study has two groups:safety observation group and immunogenicity observation     group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2     epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be     randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.   "
30289|NCT02889302|"     The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and     evaluate the safety of KPS-0373 in SCD patients.   "
30271|NCT02889484|"     Purpose: The incidence of surgery for lumbar disc hernia varies. According to the national     spine registries in Sweden, Norway and Denmark, there is a 30-60% difference in surgical     incidence between these countries. The cause for this difference is not known. It may reflect     a difference in incidence of lumbar disc hernia, but with a similar socio-economic and     ethnical background in these countries, it is more likely that the differences are due to     varying surgical indications. Comparing indications for surgery, patient reported outcome and     factors predictive for outcome after surgery for lumbar disc hernia in these countries could     provide information about optimal indications for surgery.      Hypotheses: (i) there are no differences in patient-reported outcome after surgery between     these countries, (ii) there are no differences in indications for surgery between these     countries and (iii), factors that predict outcome are similar in these countries.      Method of research: By using data from three Nordic national spine registers, we will compare     baseline data, indications for surgery and patient reported outcome one year after surgery     for lumbar disc herniation. Register based studies have advantages such as large sample     sizes, reflecting real life, but they also have limitations such as lower follow-up rates     than clinical trials. A non-response analysis will be performed to take this into account.   "
30272|NCT02889471|"     110 patients with common bile duct (CBD) stones and had one or more anther preoperative     predictors for high risk for difficult cholecystectomy admitted to departement of surgery of     Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient     divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP     after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done     within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and     methylene blue injected at the end of the procedure to detected any leak in NB group   "
30273|NCT02889458|"     Introduction: With population ageing and increasing Westernization breast cancer continues to     be important health conditions among women in Hong Kong. Greater collaborative research     efforts are needed to examine the questions about population screening for breast cancer, the     aetiology of such lesions and outcomes of breast cancer during survivorship period. There is     a lack of locally-relevant models for assessing breast cancer risk. Contribution of novel     genetic factors to breast cancer, identification of the key and functional alleles in gene     regions associated with risk of breast cancer as well as gene-environment interaction,     requires further investigation in Chinese population. Prognostic research studies in the West     may not be readily applicable to the Chinese population.      Objectives: We aim to investigate the aetiology and outcomes of breast cancer in local     Chinese by using case-control and cohort study design in the health care setting in Hong     Kong. We aim to examine potential risk factors/biomarkers (both traditional and novel), and     to build infrastructure and biobank for breast cancer surveillance. We will follow up cases     prospectively as a survivor cohort.      Methods: A hospital-based case-control study and a prospective survivor cohort study will be     conducted. Consecutive incident breast cancer and DCIS cases (n=3,500) within a 24-month     period in Hong Kong will be recruited from public hospitals, private hospitals and private     practices; and controls will be selected by frequency-matching on factors such as age and     hospital/clinic setting. Cases will be prospectively followed up over a 2-year period, and     data collection will occur at baseline (within 24 weeks of diagnosis), 6 months, 1 and 2     years following baseline assessment. Biologic samples (including both blood, and tumour and     normal breast tissue samples from the cases, and blood samples from the controls) will be     collected for later genetic and molecular study including WGS, GWAS, gene-environment     interaction and molecular functional studies. Depending on availability of pathology samples     and resources, additional studies such as tissue microarray block production will be     considered and performed in future. Data will be analysed by traditional regression, EWAS and     genetic association methods, whenever relevant.      Public Health Implications: The repository of clinical, radiological and biological materials     assembled through this case-control study will serve as a common, publicly accessible     platform for subsequent functional analysis and scientific interrogation. The case-control     findings would offer an improved understanding to the state of the science on aetiology of     breast cancer in Chinese women. In the genomics analysis, potential refined classification of     breast tumours may enhance our understanding, detection and follow-up of such lesions, as     well as enable us to have more informed targeted and personalized treatment selection for our     women population. The cohort study findings are important for developing an effective     strategy for the improvement of overall survival and quality of life for the cancer survivors     in Chinese population.   "
30274|NCT02889445|"     4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl     cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain     barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not     transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase     I/II trials in humans with primary and secondary tumors involving the brain with success.     Complete remissions in both primary (astrocytomas, GBM) and metastatic lung cancers.      This trial is open for adolescent and young adults (AYA) subjects with advanced cancer -     brain involvement is not required.   "
30275|NCT02889432|"     Orthognathic surgery is commonly performed for the treatment of dentofacial deformities. Yet,     one of the most prevalent and long-term complication encountered is neurosensory disturbance     thus impairing sensation to parts of the face. In Hong Kong, it has been reported that in     patients receiving orthognathic surgery, 5.9% experience long-term neurosensory disturbance     post-surgery.      Melatonin is a neurohormone that is produced and secreted by the pineal gland in the brain.     Its main physiological role in humans is to regulate sleep. Oral Melatonin supplements is     also used in the management of jetlag and other sleep disorders. Recently, animal and human     studies have shown Melatonin to improve tolerance to pain and to have a neuroprotective and     neuroregenerative effect after nerve injuries.      Hence, it is hypothesized that peri-surgical oral Melatonin supplement can improve     neurosensory recovery after orthognathic surgery   "
30276|NCT02889419|"     KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to     estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the     realization of self-catheterisation (SC) for patients affected by multiple sclerosis with     severe to moderate disability.      Secondly, the study aims to :        -  Estimate the effect of underwear on quality of life, tiredness linked to the act,          comfort in the realization of SC, complications with SC, third party intervention ;        -  Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd          week of evaluation ;        -  Measure if the patient reused underwear and if he bought it at 6 months and at 1 year   "
30290|NCT02889289|"     This study will evaluate the potential for improving balance for a single individual with a     history of traumatic brain injury (TBI). The participant will engage in supervised therapy     using commercial games on the Xbox Kinect. This study will also evaluate the viability of     improving cardiovascular fitness using this intervention as well. The investigators     hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable     way of improving cardiovascular fitness.   "
30302|NCT02889133|"     Primary Hypothesis        -  The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting          iron-deficient erythropoiesis will not meet FDA standards for clinical use.        -  The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron          repletion will improve significantly and will meet FDA standards for clinical use.   "
30277|NCT02889406|"     In a recent study, we have demonstrated that the motivational therapy approach to treat     childhood obesity is highly effective at clinical and metabolic levels. This efficacy has     been proved in a clinical outpatient setting. However, a standardized collaborative approach     between the clinic and the primary care services would allow a faster and easier approach to     childhood obesity treatment. Furthermore, this motivational and educational intervention     would benefit from the current technologic facilities, the long term effect of the education     at group level, in terms of food shopping plan, healthy, fast and cheap cooking methods that     would be useful specially in low income families (with a higher prevalence of childhood     obesity).      The aim of this study is assessing the clinical and metabolic efficacy of a family     intervention, coordinated between the clinical and primary care services from the Tarragona     health-care region, using a motivational therapy at individual and group levels, which     involves e-Health tools (wearable), focusing on families with an 8 to 13 years old obese     child.      The design will be a clustered randomized control trial, with an intervention group that will     receive a multicomponent motivational and educational plan which will be compared to a     control group receiving the usual recommendations performed in primary care centres (n=167     per group). The treatment of both study groups will last 12 months and will be performed at     the primary care centres. In parallel, the study team will validate the methodology used to     assess body composition in obese children as well as the changes produced by the     intervention.   "
30278|NCT02889393|"     The purpose of this study is to determine whether teduglutide is safe and feasible to be     given for the treatment of enterocutaneous fistula (ECF). We hypothesize that the drug will     be well-tolerated and will improve the volume of daily ECF output as well as improve the     functional quality of life.   "
30279|NCT02889380|"     This is a multicenter retrospective study in good prognosis Chinese patients. Data will be     collected from infertile women who underwent first in vitro fertilization (IVF)/intra     cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist     (Cetrotide) protocol at about 4 IVF centers to investigate the factors associated with     clinical pregnancy rate. The definition of the good prognosis subjects is, age not more than     35 years old, Baseline serum Follicle-stimulating hormone (FSH) level no more than 10     milliinternational units (mIU)/milliliter (ml), Body mass index (BMI) not more than 30     kilogram per meter square (kg/m^2), previously underwent no more than 3 IVF/ICSI cycles, and     the total dose of Gonadotropin used no more than 2500 IU in current cycle. No intervention(s)     will be administered on the subjects. Data required to investigate the factors associated     with the pregnancy outcome of GnRH antagonist IVF cycle will be collected from the subjects'     medical records into database through electronic data capture system and analyzed.   "
30280|NCT02889367|"     The purpose of this study is to determine the relationship between the plasma concentrations     of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate)     using exposure-response (ER) analysis.   "
30281|NCT02889354|"     The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for feasibility     and acceptability in a pilot study with a single group design. The study also evaluates     measurements and recruiting possibilities, and effects of the intervention. Research     hypotheses include: 1. There is a basis for recruiting ADHD-I patients for participation in     an RCT at psychiatric outpatient units, 2. The measurements in the study are feasible and     reasonable in regards to patient characteristics; that is, the patients are responding to the     questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible in terms of     treatment completion, compliance to home assignments, and credibility and relevance, and is     lacking of or involves a tolerable degree of adverse effects, and 4. The CBT for ADHD-I     protocol reduces core symptoms of ADHD-I as well as symptoms of stress, depression, and     anxiety, and improves quality of life.   "
30282|NCT02889341|"     Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one     months and after 2 months taken Docosahexanoic Acid or placebo.   "
30283|NCT02889328|"     Randomized, placebo-controlled, phase III study of regorafenib 160 mg once daily on     intermittent dosing schedule of 3 weeks on treatment followed by 1 weeks off demonstrated the     significant benefit of regorafenib in terms of PFS in patients with GISTs who had failed to     both imatinib and sunitinib. However, there are concerns that tumors and tumor-related     symptoms may be progressed during off treatment period. Investigators hypothesize that     continuous dosing schedule of regorafenib might be feasible and effective to prevent disease     flare on off-treatment period. Based on the results of previous dose escalation study for     continuous regorafenib dosing, we investigate the 100 mg daily dose of regorafenib in     patients with TKI-refractory GISTs.   "
30284|NCT02889315|"     Subcutaneous treprostinil is used to treat pulmonary arterial hypertension (PAH). Due to     local pain it causes a deterioration of quality of life or even abandonment of treatment. The     aim of this study was to evaluate the safety and quality of life (QoL) in patients treated     with treprostinil administration using an implantable Lenus Pro® pump. This is a     observational study involving patients with PAH treated with a subcutaneous infusion of     treprostinil with intolerable pain at the infusion site, who were therefore referred for pump     implantation. Clinical evaluation, including QoL assessment with SF-36 questionnaire was     performed at the time of initiating therapy with treprostinil, before and 2-9 months after     implantation.   "
30285|NCT02888340|"     The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in the     emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern Hospital     (ANW). The investigators suggest that the proposed intervention - provision of acupuncture in     the ED as an alternative to usual ED care - will reduce pain and interrupt the trajectory     (and potential cycle) of medication misuse by providing an alternative at a critical point of     contact within the healthcare system, potentially disrupting the pathway from ED visit to     opioid usage after discharge.   "
30286|NCT02888327|"     This open-label, four group, fixed-sequence study will evaluate the safety and     pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and     probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.   "
30287|NCT02888314|"     The goal of this study to evaluate the association between Pokemon Go and physical activity     through a survey among Pokemon Go players.   "
30291|NCT02889276|"     This study will be the first to examine the effects of a functional resistance exercise     programme that closely replicates daily activities and their effects on quality of life, body     composition and functional fitness in cancer survivors. This study will also use a supervised     and group based exercise setting to help with socialisation and confidence with an aim to     improve the exercise experience. Eligible participants should be 18-90 years old, been     treated for colorectal cancer (stages I-IV) in the previous 3 months to five years and with     no limitations to exercise. The study will include a 12-week exercise period where     participants will be randomly allocated to the control group or to take part in 32 supervised     one-hour group exercise sessions involving exercises to target the whole body at a moderate     intensity which will take place in the Mountbatten Centre, Pyramids Centre, Fareham Leisure     Centre or Horizons Leisure Centres. Depending on participants' membership status those in the     control group could use the centre's exercise referral programme, which has a cost attached,     or they will be encouraged to meet national physical activity recommendations by walking 30     minutes per day on most days of the week. The only difference between the two groups will be     the supervised group functional resistance training. At the beginning and end of the 12-week     study period a number of health-related fitness tests will be performed to assess health     outcomes, such as resting blood pressure & heart rate, respiratory function, body fat     measures (body mass index, waist circumference and body fat %), functional performance     measurements, handgrip strength, a 6 minute walk test and self-efficacy to regulate exercise     and measures of quality of life questionnaires. Participants will be provided with their own     results and an overview of the whole study data.   "
30292|NCT02889263|"     The problem of rehospitalizations in the US is well documented but poorly understood.     Although Medicare compares the rates of rehospitalization across the country, we have found     no comparison of different countries. This is a first attempt to compare rehospitalization in     the US with France where national health insurance (NHI) provides easy access to primary care     but, like the US, policymakers struggle to improve coordination between hospitals and     community-based health care providers.Although France's NHI system with central state     intervention differs from the United States' tradition of federalism, private health     insurance and pluralism, policymakers seek to achieve cost savings and to reform the health     care system. A recent literature review on avoidable rehospitalization of older persons in     France cited studies on the topic and relied largely on ones from the US. Starting in 2013,     the Center for Medicare and Medicaid Services' (CMS) 'Hospitals Readmissions Reductions     Program' withheld up to 1% of regular reimbursements for hospitals with higher than expected     (by CMS) rates of rehospitalization, within 30 days of discharge, due to heart attacks, heart     failure and pneumonia. CMS increased this to 2% in 2014, will raise it to 3% in 2015 and may     subsequently expand the list of conditions for which it will penalize early     rehospitalizations. Policymakers in France have been reluctant to implement a hospital pay     for performance system based on a rehospitalization indicator whose validity is a subject of     considerable controversy. Despite the controversy and differences in approach, a comparison     of rehospitalizations between the US and France provides a cross-national perspective on a     timely policy issue facing both countries.   "
30293|NCT02889250|"     This is an open label study with a sample size of 6 to develop deep brain stimulation of the     subcallosal cingulate white matter(SCCWM) for late life depression using an experimental     medicine approach in which the investigators will program the device based both on 1) a     neurophysiologic measure of target engagement and 2) safety (defined as lack of     neuropsychiatric worsening and stable neurocognition).   "
30294|NCT02889237|"     This study is designed as a single-blind RCT in 80 postmenopausal women to compare the effect     of immediate administration of daily calcium supplementation (1000 mg calcium) or two daily     dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium + 1760     IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture) in     terms of calculated bone strength based on analysis of cortical and trabecular bone     parameters using HR-pQCT, fracture healing and functional outcome.   "
30295|NCT02889224|"     Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and     cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in     the pathophysiology of Cushing's syndrome.      The investigators speculate that:        -  acute or chronic variations in plasma cortisol may induce changes in the activity of the          ECS        -  that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol   "
30296|NCT02889211|"     The purpose of this study is to help researchers learn about how the brain responds to     rewards. This study is interested in seeing how these responses differ between people who are     more and less responsive to insulin in their body, and people with and without depression.   "
30297|NCT02889198|"     The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with     Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools     designed to help child care programs improve their nutrition environment (specifically     classrooms serving 3-5 year olds) over the course of 4 months.   "
30298|NCT02889185|"     This study aims to assess the contribution of the multimodal imaging, combining a routine     examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive     optics retinal camera.      This is a feasibility study with a limited number of patients.   "
30299|NCT02889172|"     The purpose of this study is apply a Brief Intervention (PST) in Diabetic and Obesity patient     in primary care of Mexico City to improve their depressive and anxious symptoms and     stabilization of metabolic variables.   "
30300|NCT02889159|"     Chronically photodamaged skin is visually characterized by dryness, wrinkles, brown spots,     leathery appearance, etc. This happens as a result of excessive exposure to UV light from the     sun. While the sun's exposure leaves the skin's surface visibly changed, the skin's unseen     immune system may also be permanently altered as a result of the exposure, making it more     likely to develop a variety of skin cancers and infections. This study will examine the     lasting changes in the immune system of the skin caused by UV exposure. Investigators will     stimulate different aspects of the skin's immune system by giving an injection of Candida     Albicans (CANDIN®) and histamine phosphate (HISTATROL®), topical applications of imiquimod 5%     cream (ALDARA®) and performing a tape stripping procedure with adhesive tape. The use of     Candida Albicans (CANDIN®), histamine phosphate (HISTATROL®), and tape stripping are common     procedures in clinical settings to stimulate skin desired skin responses. Imiquimod 5% cream     (ALDARA®) is an FDA-approved drug for the treatment of basal cell carcinomas, actinic     keratoses and genital warts. Investigators will compare the reaction of the skin's immune     system on a cellular level from skin normally exposed to the sun exposure to an area normally     hidden from sun exposure.   "
36714|NCT02805114|"     This is an observational study which aims to evaluate the possibility of using data from a     capnography device to assess obstructive airway severity in both Chronic Obstructive     Pulmonary Disease (COPD) and Asthma patients.   "
30303|NCT02889120|"     Prescription of medicines by telephone in French medical call Centres is a part of the     general practitioners activity.      This study aimed to described drug prescription by phone (MTP) performed in four medical call     centers. The primary objective is to evaluate adherence to french practice guidelines for the     drug prescription by phone (Haute Autorité de Santé, 2009) The secondary objective is to     evaluate the risk/benefit ratio for drug prescription by phone.   "
30304|NCT02889107|"     This study aimed to evaluate long term benefits in speech reception in noise, after daily 10     week use of an assisting listening device (personal frequency-modulates systems) , in     non-aphasic stroke patients with auditory processing deficits.   "
30305|NCT02889094|"     The overarching purpose of this study is to further understand the reasons for and clinical     implications of persistent HBV infection in patients co-infected with HIV and HBV in the era     of highly effective antiviral treatment against both viruses.   "
30306|NCT02889081|"     The study is a prospective birth cohort study and the purpose is to describe the status of     maternal key nutrients(eg. folate and vitamin D) supplementation among pregnancies at early     gestation in Shanghai, to find out the association between the level of serum key nutrients     and atopic dermatitis (AD) in offsprings during 6 months.   "
30307|NCT02889068|"     The purpose is to determine the benefit of next generation sequencing (NGS) targeted on genes     involved in intellectual disability for etiologic diagnosis of intellectual disabilities. In     other words, it concerns the number of patients whose etiologic diagnosis will be established     with NGS and could not with common techniques. Actually, the molecular etiology of     intellectual disability is crucial to calculate the risk of recurrence and allows the     perinatal diagnosis to these families.      Secondary purposes are:        1. To determine the place of NGS in the strategy of etiologic diagnosis of intellectual          disability, to determine the order of analyses performed for a patient with intellectual          disability without clinical signs.        2. To evaluate the number of variants with unknown significance and thus non-usable for          genetic counselling without supplementary analysis.        3. To determine the number of samples that can be at most pooled keeping a good efficacy of          capture and results with suitable read depth        4. To determine the possibility of detecting copy number variations (CNVs) in genes of          interest with NGS        5. To establish genotype/phenotype correlations for each gene for which a mutation has been          identified        6. To optimize the software pipelining for a rapid analysis for diagnosis.   "
30308|NCT02889055|"     Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the     lightest possible sedation strategies, avoiding the administration of benzodiazepines source     of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion.     Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane)     in resuscitation is interesting because their favorable pharmacokinetic even after prolonged     administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.      There are two suitable delivery devices sevoflurane in intensive care, both with CE marking.     The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use     and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma     resuscitation and cardiovascular resuscitation.      Specifically, it will use this modality in case of failure with conventional sedation     products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to     severe agitation.   "
30309|NCT02889042|"     France is one of the European countries with the highest rate of death by suicide, more than     10 400 deaths each year, about 16 people out of 100 000. Although suicide mortality rate     tends to fall between 1987 and 2008 the number of suicide attempts (TS) against observed by     an upward trend between 2005 and 2010. However, the most important predictor of death by     suicide remains the TS. Now these are primarily TS Poisoning Drug-Volunteer (IMV), especially     benzodiazepines. These IMV, there have been 16% recurrence in the past year and 21% at 4     years among hospitalized patients. Or a Health Barometer 2005 survey showed that 58% of     respondents with a TS over the last 12 months had not been hospitalized. This type of acting     out, especially the repeated IMV (IMVr) is underestimated epidemiologically because it is an     unknown phenomenon and too little screened by health professionals.   "
30310|NCT02889029|"     Management of complex airway stenoses with dedicated tailored stents wrought by 3D     computer-assisted conception      Dedicated Airway Stents for Central Airway Stenoses      DASCAS      Toulouse University Hospital is the sponsor of this research.      This research will be conducted with the support of AnatomikModeling and ADERSPOT        -  Background: Tracheobronchial stent are devices designed to manage central airway          stenoses of various origins. Their shape and sizes are however not suitable for stenosis          of complex anatomy.        -  Purpose: The investigators propose to test the feasibility and safety of treating          complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted          conception      Abstract: Central airway obstruction is currently managed with non-personalized stents, which     are usually efficient but lead to severe and potentially lethal complications in 10% of cases     (stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem     particularly unsuited for anatomically complex stenosis.      Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D     chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically     improve the tolerance and safety of such prostheses.      This first feasibility study, dedicated to patients suffering from anatomically complex     stenosis will test the safety of treating patients with these new approach. It should lead to     larger studies evaluating these new types of stents in larger indications.      After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are     designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The     stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the     same terms as pre-existing models.      Close follow up is then conducted, including clinical evaluation after one week, three and     six months; spirometry at one week and 6 months and chest CT-scan at one week.   "
30311|NCT02889016|"     This study is an investigation of the neurologic, immunologic, and rheumatologic markers of     Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a condition characterized by     the abrupt, dramatic onset of obsessive compulsive disorder (OCD) and/or eating restriction     accompanied by equally abrupt and severe co-morbid neuropsychiatric symptoms, which include     anxiety, emotional lability, depression, irritability, aggression, oppositionality,     deterioration in school performance, behavioral (developmental) regression, sensory     amplification, movement abnormalities, sleep disturbance, and urinary frequency. PANS is     thought to be caused by infection, inflammation, or alternate triggers that is associated     with a brain response that leads to these symptoms. The purpose of this study is to examine     specific neurologic, immunologic, rheumatologic, and genomic, components in children with the     acute-onset of psychiatric symptoms. This research may begin to uncover a much larger story     of autoimmune processes that are involved in psychiatric disorders of childhood. By better     understanding the etiologic components of psychiatric phenomenon, future treatments may be     better targeted to underlying causes.   "
30312|NCT02889003|"     Single-center study, prospective, phase II trial.      The study objectives are :        -  To assess safety of the combination of Pioglitazone and TKI in CML subjects who          experience a loss of MMR following a first TKI discontinuation.        -  To assess survival without loss of MMR over a 12 months period following a second TKI          discontinuation in subjects who achieve or maintain < MR4.5 with the combination          Pioglitazone and TKI administered for at least 6 months.   "
30313|NCT02888990|"     1. The use of imatinib in combination or in association with chemotherapy is now considered          as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is          90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine          and dexamethasone is a well tolerated regimen in aged patients and is also associated          with a high CR rate of 80% to 90% in patient aged 55 years and over.        2. However, despite high CR rates, the progression free survival rate at 12 months of          patients treated with the combination of imatinib and chemotherapy is 30% to 50%.          Relapses remain frequent and only patients intensified with allogenic haematopoietic          stem cell transplantation are in long term remission. This strategy is not fully          applicable to most patients aged 55 years and over.        3. Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with          BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop.          The exact incidence of the T315I mutation is controversial and can be estimated to be          near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a very          strong predictor of relapse.        4. Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro          activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317          mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain          mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to          imatinib is 33% and the median progression-free survival is 3.7 months. Progression free          survival (PFS) rate at 12 months is 22%.      The goal of this trial is to evaluate the efficacy and the tolerance of the combination of     dasatinib with chemotherapy in the front-line setting as induction and consolidation therapy     in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a     common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be     used in this trial with the addition of dasatinib as concomitant therapy during induction and     alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and a     progression free survival of 60% at 12 months are expected. The patients will be     prospectively monitored for minimal residual disease and mutation.   "
30314|NCT02888977|"     The use of imatinib in combination with chemotherapy is now considered as the gold standard     for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with     chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well     tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90%     in patient aged 55 years and over. 2. Dasatinib is indicated as first line therapy in Ph+     ALL. Results from the EWALLPH-01 are supporting the use of dasatinib in combination with     low-intensity chemotherapy. A new EWALL-PH-02 study combining nilotinib in combination with     low-intensity chemotherapy is currently initiated within the EWALL centers.      3. The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The activation     of the EWALL-PH-02 trial is expected for Q1 2012. Based on the recruitment of the EWALL-PH-01     study it could be anticipated that 50 to 100 patients aged more than 55 years will be     diagnosed during this 6 months period of time. In addition, all the EWALL centers are not     participating to the EWALL-PH-02 study and thus these centers could be offered to treat     patient following the EWALL backbone in addition to imatinib. 4. A minimum data set will be     defined in order to collect the data of the patients treated following the EWALL-PH imatinib     study. The main recommendation is to follow as close as possible the procedures of the     EWALL-PH-01 trial (mutation analysis, MRD follow-up) in order to have a comparable data set.     This imatinib treated cohort of patients would be of particular importance in order to better     define the potential benefit of using one TKI compared to one other. From the end of the     EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02 study, patients were     treated following the common backbone schedule in combination with imatinib or others TKI.     Patients not included in clinical trials for other reasons were also offered a treatment with     the combination of TKIs and backbone low-intensity chemotherapy. The goal of this observatory     retrospective and prospective is to describe the efficacy and the tolerance of the     combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy     (EWALL backbone) in patients with Ph+ ALL aged 55 years and over.   "
30315|NCT02888964|"     This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of     the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®)     in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e.     a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European     Leukemia Net recommendations) after at least 2 years of therapy with imatinib.      Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase     (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not     eradicated by imatinib alone in almost any of the patients.      Treatment discontinuation in patients treated by imatinib and in complete molecular remission     for more than 2 years yield molecular relapses within 6 months in half of the     patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for     CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the     dysregulated activity of BCR-ABL in CML.      Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A     and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential     therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical     studies, we went ahead and administered pioglitazone to one patient who suffered from both     diabetes type II and CML with residual disease after continuous treatment with Gleevec. The     amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3     months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months     post-treatment, the latest time point assessed. This striking anecdotal result now forms the     rationale for filing this formal Phase II clinical trial application.   "
30316|NCT02888951|"     This study evaluates the amount of fluid remaining in the stomach of diabetic patients after     a standard fasting period, and compare it with non-diabetic patients coming for elective     surgical procedures.   "
30317|NCT02888938|"     The aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac     joint (SIJ) MRI compared to CT scan of SIJ for the diagnosis of structural sacro-iliitis and     2° to quantify structural elementary lesions on MRI and for the first time on CT-scan     according to a SPARCC approach in a cohort of patients with a suspicion of spondyloarthritis     (ECHOSpA).   "
30318|NCT02888925|"     The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face     perception by comparison of performances of epileptic patients and control individuals, sex-,     age- and socio-educational level-matched.      Secondary purposes are to prospectively evaluate neuropsychological impact of anterior     temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face     perception (exploratory study).   "
30319|NCT02888912|"     The aim of this clinical trial was to compare the clinical performances of a glass ionomer     restorative system with a micro hybrid resin based composite in class I and class II     cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored     with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct).     Restorations were evaluated at baseline and yearly during 6 years according to the     modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).   "
30339|NCT02888652|"     Study on the registration of coronary heart disease patients undergoing PCI in Chinese's     population. Get the incidence of adverse events in these patients after PCI, a clear type of     adverse reaction, forms, influencing factors, to establish risk management processes,     clinical safety and reasonable treatment, and provide the basis for further research and     reference.   "
30340|NCT02888639|"     The pharmacoepidemiological EPHEYL (Étude PHarmacoÉpidémiologique de l'hYperparathyroïdie     secondaire en Lorraine) study is a 2-year, open-cohort, prospective, observational study on     incident SHPT, i.e. newly diagnosed, with a 2 year follow-up, set in the 12 dialysis units     located in the French region of Lorraine (public or private).   "
30341|NCT02888626|"     A single-center prospective, open-label uncontrolled pilot study. Subjects will receive up to     7 laser treatments, spaced 1 to 8 weeks apart, and will be followed at 2 weeks (±1 week)     post-first treatment and 12 weeks (±2 weeks) post-final treatment.   "
30320|NCT02888899|"     Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The     prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women     have been reported. Quality of life in patients with FI is decreased considerably, in a     similar extent as in patients with ulcerative colitis in relapse.      Management of FI usually involves a stepwise approach; beginning with more conservative     strategies and moving on to more appropriately tailored medications, bowel-retraining,     biofeedback and psychosocial support. Although a combination of these treatment alternatives     often improves symptoms they are not always successfully. Neuromodulation is a relatively new     treatment modality for FI that is based on recruitment of residual anorectal neuromuscular     function pertinent to continence by electrical stimulation of the peripheral nerve supply.     Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs direct     electrical stimulation of the sacral nerves. Recently an alternative neuromodulation     technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial     nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar     nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve     may lead to changes in anorectal neuromuscular function similar to those observed with SNS     but without the need of a permanent surgically implanted device. Tibial nerve stimulation is     therefore an attractive treatment alternative for FI patients since the treatment is     well-tolerated and treatment results have been very promising.      Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation (PTNS)     in combination with biofeedback on symptoms in consecutive FI patients compared with     biofeedback alone. The investigators also aim to study which FI patients have most profit of     the addition of PTNS.      Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology,     University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will     be mailed to the FI patients and they are instructed to record their FI symptoms, bowel     habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before     consideration of enrolment into the study, gastroenterologists assess all the patients'     medical history and perform a physical examination. Subjects will also have an endoanal     ultrasonography and the investigators will measure rectal volumes, sensational thresholds and     anal sphincter function.      FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in     combination with biofeedback or biofeedback alone. The treatment will be performed by     physiotherapists.   "
30321|NCT02888886|"     The purpose is to study the correlation between systemic inflammation (serum levels of CRP,     IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a     representative cohort of patients with chronic obstructive pulmonary disease (COPD).      Secondary purposes are:        1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular          morbidity in patients with COPD,        2. To establish the role of various genetic polymorphisms in the correlation between          systemic inflammation and cardiovascular disorders observed in COPD,        3. To search for acceleration of aging of cardiovascular system evaluated with carotid          intima-media thickness when systemic inflammation markers are increased,        4. To study the correlation between COPD risk factors (tobacco and other food factors),          change of respiratory functional data and cardiovascular morbi-mortality. In this study          cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy,          left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is          confirmed with standard techniques and independently of this study. Results of clinical          examination, ECG, echocardiography and /or brain scanner will be collected.   "
30322|NCT02888873|"     The aim of this randomized, prospective clinical study was to compare the clinical     performance of a universal light-curing, ultra-fine particle hybrid composite with a new     version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.   "
30323|NCT02888860|"     It is proposed to carry out the study in three medical or surgical intensive care units (ICU)     in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see Figure     2), a corrected index of colonisation (CIC) will be determined and blood samples will be     taken for genotyping of the lectins MBL, Dectin-1 and Galectin-3 and for serology. Over the     duration of hospitalisation (on average 28 days) and weekly, fungal colonisation will be     assessed in all patients (according to the CIC), and antibodies to yeast glycans will be     determined by a simultaneous multiparametric analysis involving several families of natural     or synthetic antigens, and the detection of circulating antigens (mannan and β-1,3 glucan).   "
30324|NCT02888847|"     Compare teeth sensitivity using bleaching protocol with different light intensities (Philips     Zoom!™ White Speed whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.) versus     bleaching protocol with the same light intensity (Philips Zoom!™ Advanced Power whitening gel     and lamp, Discus Dental, Inc., Culver City, CA, USA.).   "
30325|NCT02888834|"     Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general     population. Adverse drug reactions (ADR) are common in this population. In elderly subject,     prevalence of ADRs ranged from 4.3% to 63.0%.      Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their     preventability.      Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of     Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65     years who presented a serious ADR notified to the Regional Pharmacovigilance Center were     included in the study.   "
30326|NCT02888821|"     A school-based behavioral intervention for Mexican youth with attention/behavior concerns     (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas     para el Éxito [CLS-FUERTE]:) will be pilot-tested in a mixed-method investigation with four     Mexican elementary schools.   "
30327|NCT02888808|"     Obesity is a strong risk factor for GERD. This study assessed the role of obesity among     patients having erosive GERD and controls.   "
30328|NCT02888795|"     Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a     long time. However the study about the mechanism is scant. The question of biomarkers of knee     OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved. On     this basis, the aim of this study was to characterize the secreted protein factors behind the     inflammatory potential involving the hypertonic dextrose prolotherapy of knee OA.      10~12 older than 65 years old knee OA patients will be recruited for clinical Western Ontario     McMaster University Osteoarthritis (WOMAC) index, knee X ray evaluation and knee joint     synovial fluid analysis before and after hypertonic dextrose prolotherapy. The expressions of     inflammatory factors will be measured by a novel cytokine antibody array methodology. The     study will evaluate inflammation-related cytokines in patients of knee joint synovial fluid.     Human Cytokine Antibody Array that allows profiling synovial fluid production of anti and     pro-inflammatory cytokines simultaneously. Altered levels of cytokine from the array     membranes incubated with tissue lysates will quantitatively depict as a histogram for     relative cytokine induction or reduction in the synovial fluid. The cytokines messenger     ribonucleic acid levels will be quantified by quantitative reverse-transcription polymerase     chain reaction and proteins expression was analyzed by Enzyme-Linked ImmunoSorbent Assay. The     WOMAC Index, minimum joint space width, and Human Cytokine Antibody Array between before and     after interventions will be compared. Differences between groups will be determined by the     Mann-Whitney U test. For the synovial angiogenesis is accompanied with inflammatory feature     in knee OA, associations between endothelial growth factor (VEGF) expression and VEGF     isoforms pattern will be determined with the Spearman correlation.   "
31158|NCT02877914|"     This study will use a two-stage random sampling design to create a nationally representative     sample of patients with heart failure (HF) in China. The investigators sought to describe the     clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to     identify targets for care quality improvement.   "
30329|NCT02888782|"     Patients who are discharged from hospital can be overwhelmed when they suddenly have to     manage new conditions or medications. These changes can be particularly difficult for people     on many medications or with multiple health conditions. There is a real risk that this will     lead to emergency room visits, hospital readmission, and even death. In addition to     endangering patients, these adverse events are very costly to the healthcare system. The good     news is that these events can be preventable if patients receive care that is better     coordinated.      Patient-oriented research will be conducted to determine if a pharmacist-led medication     therapy management service can improve health outcomes of 'medically complex' patients     transitioning from acute to primary care in Newfoundland and Labrador (NL). This a more     comprehensive service than their community pharmacist would normally provide. The program     will use a new Pharmacist Clinic service to provide care and support which does not currently     exist for patients in NL after they leave hospital. After discharge, patients will be     randomly divided into two groups: one group will receive care as usual from their doctor; the     other group will have their medications assessed by a clinic pharmacist within one week of     hospital discharge along with their usual care from their doctor. The two groups will be     compared to determine whether specialized pharmacist services after hospital discharge is     satisfactory to patients/providers, improves patient health, and reduces emergency room     visits, hospital readmissions, and repeat trips to the doctor. If successful, this project     will help ensure that patients are taking the right medications in the right way, improving     individual health and making better use of healthcare system resources.   "
30330|NCT02888769|"     The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to     evaluate the effectiveness of automated mobile phone text message-based intervention for     secondary prevention, including lifestyles modification, medication adherence improvement and     risk factors control among coronary heart disease (CHD) patients without diabetes. The     participants will be randomized into intervention and control groups in a 1:1 ratio. The     intervention group will receive 6 pre-designed text messages per week in addition to usual     care for 6 months, while the control group will receive usual care.   "
30331|NCT02888756|"     iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients based     on in vivo modification of DCs. It consists of HIVACAT-TriMix: mRNA encoding a mixture of APC     activation molecules (CD40L, a constitutively active variant of TLR4 and CD70) and the HIV     target antigens contained in HIVACAT to be administered through the intranodal route.     iHIVARNA-01 aims to achieve the 'functional cure' of HIV infection, i.e. controlling viral     replication in the absence of anti-retroviral therapy.   "
30333|NCT02888730|"     Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial     colonization is facilitated by a reduced mucociliary function and some previous studies     suggest that the microbiology of the upper airways might influence the microbiology of the     lower airway. The aim of this randomized control study is to demonstrate efficacy of     antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in     sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores,     quality of life and lung function   "
30334|NCT02888717|"     The para-aortic lymph node involvement in the advanced stage of cervical cancer is a poor     prognostic factor for overall survival. Concomitant chemo-radiotherapy has become the     standard treatment for advanced cervical cancer. In case of para-aortic lymph node     involvement, an extension of radiotherapy fields is recommended.      A prospective multicentre study shown that the survival rate of patients with node ≤ 5 mm and     which benefited from the expansion of radiotherapy fields was identical to the survival of     pN0 patients.      However, due to a specific disease, this technique should not be performed in all patients.     It is necessary to reliably select patients with retroperitoneal lymph node involvement. For     this, it is recommended that prior to the concurrent chemo-radiotherapy, nodal staging     surgery with a definitive histological analysis.      So we propose to use molecular diagnostic test OSNA (One Step Nucleic Acid Amplification) to     improve lymph node metastasis detection sensitivity to achieve ultra-staging compared to     conventional histology.   "
30335|NCT02888704|"     This study aims to evaluate safety, tolerance, and efficacy in subjects with over moderately     subacute and chronic atopic dermatitis after an intravenous injection of autologous     mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine clinically     proper dose capacity of the ADSTEM Inj. and step 2 is to evaluate exploratory efficacy of the     ADSTEM Inj. at the proper dose.   "
30336|NCT02888691|"     The aim of the study is to investigate glycemic control during a low carbohydrate diet     compared with during a high carbohydrate diet in adults with insulin pump treated type 1     diabetes.   "
30337|NCT02888678|"     This study evaluates whether the integration of an Economic Strengthening program with an     HIV-prevention education program produce synergistic effects on economic and health outcomes     for South African youth ages 14-17 years old.   "
30338|NCT02888665|"     This phase I/II trial studies the side effects and best dose of doxorubicin hydrochloride     when given together with pembrolizumab and to see how well they work in treating patients     with sarcoma that have spread to other parts of the body or that cannot be removed by     surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab,     may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin     hydrochloride together with pembrolizumab may work better in treating patients with sarcoma.   "
31166|NCT02877810|"     The purpose of this study is to determine the impact of an existing tele-emergency care     network on quality of care, appropriateness of care utilization, patient safety (medication     errors), and cost effectiveness compared to telephone consultations from a healthcare system     prospective.   "
30342|NCT02888613|"     This study aims to compare the results of two mini invasive surgical approaches in abdominal     aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with     transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit     will be assessed after 30 days.      The secondary purpose of this study is to assess the life quality and morbi-mortality at 30     days, as well as at 6 and 12 months.   "
30343|NCT02888600|"     This study is a two-arm randomized controlled trial comparing two 8-week stress management     programs for reducing inflammation and improving well-being among older adults.   "
30344|NCT02888587|"     The study has two objectives:        1. To obtain endoscopic and colonoscopic biopsies to harvest and culture intestinal crypts          from human tissue to produce organoids. These organoids will be used to study the          biology of innervated sensory epithelial cells.        2. to collect subject data relating to clinical management and demographic characteristics          of patients undergoing upper endoscopy or colonoscopy to learn the mechanisms behind          visceral hypersensitivity, and neurodegenerative diseases that may arise in the gut.   "
30345|NCT02888574|"     This study is a placebo-controlled, double-blind, within-participants crossover investigation     of the effect of intranasal oxytocin on pain and function among women with chronic pelvic     pain.   "
30346|NCT02888561|"     Patients with poor heart function can, in certain situations, have a further weakening of the     heart muscle such that it becomes difficult to provide enough blood to the brain and other     organs. In these cases, heart function can be supported by the use of medicines or heart     pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip).     Although Dobutamine has been in use for decades and does improve blood flow to the organs,     previous studies have not shown any impact on recovery of heart muscle function and survival.     Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the     oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether     simultaneous infusion of another drug called Nitrite (naturally occurring substance that is     found in beetroot for example, much like GTN) can enhance the beneficial effects of     Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances     in technology mean that it is now possible to obtain this information in patients undergoing     coronary angiography procedures by making detailed measurements of heart muscle function and     blood flow in the heart arteries using a conductance catheter (measures volume and pressure     within the main pumping chamber of the heart) and the Combowire (dual pressure and flow     sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a     brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen     usage through this use of this technology, directly following the patients routine coronary     angiogram. Patients will have these measurements taken using the technology described above     during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach     the heart.   "
30347|NCT02888548|"     Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies     suggested combining botulinum toxin injections with splinting to optimise rehabilitation in     spastic patients. However, one study focused exclusively on lower limb spasticity, the second     on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.      A study was performed in adult patients with upper limb spasticity treated with botulinum     toxin injections used as primary objective the tolerance for dynamic splinting. The authors     noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been     conducted to date on the splinting + toxin combination in adults.      Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum     toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this     reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days     after botulinum treatment.      Based on this principle, we hypothesise that dynamic night splinting applied just after     botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint     providing continuous stretching of the wrist and fingers in extension whilst allowing active     flexion. Night splinting is thought to promote optimal functional use of the paretic upper     limb during the day and thus prevent learned non-use, which could worsen the spasticity.      Each patient will receive treatment cycles, whose results will be compared, so that each     patient will act as his/her own control. The evaluation will be based on the Tardieu scale     chosen for its greater inter-individual reproducibility and greater reliability to measure     spasticity.      The degree of extension of wrist and fingers provided by the splint will be adjusted to the     patient's clinical condition with the elastic tensioners. The purpose of the splint is to     maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching     maximum extension, which could be harmful.      This protocol is designed to determine whether dynamic night hand splinting combined with     botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain     damage.   "
30348|NCT02888535|"     Primary immune deficiencies (PID) are characterized by a failure of the immune system that is     not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300     different inherited rare disorders were described. The occurrence of PID in adult is rare and     diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are     based only on expert recommendations and do not include comprehensive symptoms of PIDs.     Recurrent infections, more aggressive, are the most common mode of revelation of the PID.     Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic     granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID.     The objective of this study was to evaluate the occurrence of unknown PID in adult admitted     in critical care unit and to determinate if the investigation of PID in patients with severe     infections or HLS should be routinely performed in MCIU.   "
30349|NCT02888522|"     Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment     of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality     and occur in about 30% of cases. The occurrence of relapses is important during the first     three months post-allogeneic transplant, then gradually decreases during the first year     post-allograft and then becomes weaker. After relapse, therapeutic options include the     reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy     or a new transplant. The performance is influenced by the early introduction of treatment     whose effectiveness is related to the importance of tumor burden. Immunomodulation of     preemptive strategies have recently been established by decreasing immunosuppression and     achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.      The aim of this study is to evaluate the incidence of relapse following the recommendations     of post-allogeneic transplant immunomodulation of the French society of bone marrow     transplantation.   "
30350|NCT02888509|"     To explore the neural and cognitive mechanisms of depression (including unipolar depression     and Bipolar disorder) and anxiety using multimodal MRI techniques.   "
30351|NCT02888496|"     Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at     characterizing immunological abnormalities in PMR patients, and to assess the effects of     tocilizumab therapy on this abnormalities.   "
30352|NCT02888483|"     The overall objective of this project is to evaluate and validate the accuracy and usability     of a deployed beta sensor-based system. This is a cross-sectional validation study of 100     apparently health community dwelling adults aged 60+ years. Participants will perform     standardized lifestyle, exercise and sedentary type physical activities in a clinic     laboratory and home setting.   "
30353|NCT02888470|"     The aim of the study is to estimate the proportion of intensive care unit patients receiving     current aminoglycosides dosing regimens as part of their antibiotic therapy and achieving the     recommended maximal plasma concentration (Cmax) after the first and subsequent aminoglycoside     doses.   "
30354|NCT02888457|"     Rationale      In Belgium, a unique situation exists for two reasons: on the one hand, the pneumococcal     conjugate vaccine (PCV) program, which started in 2007, has quickly reached high coverage in     infants: 3-dose coverage rose from 89 % in 2008 to 96.5 % in 2012 in Flanders and from 80.7 %     in 2009 to 89.2 % in 2012 in Wallonia; and on the other hand, serotype coverage has moved     from PCV7 (since 2007) to PCV13 (since 2011) and very recently to PCV10 (since July 2015 in     Flanders and expected in May 2016 in the French Community). Invasive pneumococcal disease     (IPD) surveillance has demonstrated a major impact on PCV13 serotypes in infants < 2 years of     age. The impact of the current change in PCV-program is hard to predict, but could eventually     result in a re-emergence of serotypes not covered by PCV10 (i.e. 3, 6A and 19A).      With this unique situation the foundation was laid for a carriage study during which the     nasopharyngeal carriage of Streptococcus pneumonia (Sp) and other common colonizers of the     nasopharynx will be studied in infants with acute otitis media (AOM) and in healthy infants     attending day-care centers (DCC), two populations with high reported pneumococcal carriage.     Young children are an important reservoir and major source of transmission of bacteria to the     whole community and thus the preferred population to study nasopharyngeal (NP) carriage.      Aim of the study      The main aim of this study is to evaluate if changes in the conjugate anti-pneumococcal     vaccination program in Belgium have an impact on the nasopharyngeal carriage of Pneumococcus     in infants aged 6-30 months suffering from AOM or attending day-care, in order to guide     future pneumococcal vaccine program decisions and vaccine development, and to feed AOM     treatment guidelines in a PCV-program environment. The study will monitor overall     pneumococcal carriage, the serotypes involved and the sensitivity of the isolated strains to     antibiotics. In addition, the rhinopharyngeal carriage of other common nasopharyngeal     colonizers associated with disease, in particular Haemophilus influenzae, will be studied in     order to evaluate if changes in pneumococcal carriage impact on the carriage of those     pathogens. In infants with AOM, the study will also monitor the clinical course of the AOM     and a second nasopharyngeal sample will be taken in case of antibiotic treatment failure or     AOM recurrence to identify any association with the carried pathogen.   "
30355|NCT02888444|"     A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully     stop smoking after taking varenicline are less likely to relapse back to smoking if they     continue using varenicline for a further 12 weeks   "
30356|NCT02888431|"     The purpose of this study is to determine the correlation between pH, base deficit, and     lactate values when comparing venous and arterial blood samples in the pediatric population.   "
30357|NCT02888418|"     This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine     (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17     years old and preliminarily explore the immunogenicity.      135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of 9     to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15     women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30     women and 30 men in vaccine group and 15 women and 15 men in placebo group.   "
30358|NCT02888405|"     The present study sought to investigate the effects of acute dietary changes on estimates of     body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body     weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of     carbohydrate) were examined.   "
30359|NCT02888392|"     The proposed study will primarily demonstrate the efficacy of kiwifruit as a food     intervention for the relief of constipation and associated symptoms in functionally     constipated adults, and those with IBS-C. Secondary measures will show the consumption of     kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with     IBS-C.   "
30360|NCT02888379|"     A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the     Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in     Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity   "
30361|NCT02888366|"     This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for     breast -related symptoms or signs. Breath tests will be performed in order to demonstrate     that the outcome of mammography results combined with breast test results improves clinical     sensitivity and specificity in a group that has an increased prior probability of cancer.     Breath will be collected and analyzed with a rapid point-of-care instrument (BreathLink™) and     also with a laboratory-based assay of samples collected into an inflatable bag (BreathBag™).   "
30362|NCT02888353|"     Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter     Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic     Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has     been established in patients with pacemakers or ICD's but only in patients in whom strict     vetting procedures were implemented. These vetting procedures were initially developed to     eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over     recent years however, objective scientific evidence has failed to support this concern     raising the question as to whether or not these vetting procedures are necessary.      Investigators hypothesize that in view of the existing objective scientific data, evolution     of device technology and the fact that the investigators have scanned more than 2,000 devices     safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously     excluded from MRI protocols can be safely scanned without prior vetting.      This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an     implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike     previous studies where strict vetting procedures were implemented pre-procedure, All patients     with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the     study provided participants meet standard MRI inclusion/exclusion safety criteria.   "
30376|NCT02888119|"     This study aims to develop, evaluate and translate highly accelerated imaging sequences (each     protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical     3T scanner using novel compression sensing and parallel imaging strategies.The overarching     objective of the study is to establish a non-invasive imaging biomarker based on the     development of rapid relaxation mapping with compressed sensing (CS) that will be clinically     useful for assessment of early Osteoarthritis. A total of 90 subjects including 30 patients     with high risk of developing knee OA, 30 patients with mild OA and 30 healthy controls will     be accrued.   "
30363|NCT02888288|"     The purpose of this study is to evaluate if implementing an adapted Human Immunodeficiency     Virus (HIV) curriculum plus mental health intervention versus HIV curriculum alone is     acceptable and feasible and if it improves mental health, antiretroviral therapy (ART)     adherence, and virologic outcomes among HIV-positive adolescents. HIV curriculum will     continue to take place prior to the start of the monthly Saturday youth clinic. Mental health     intervention sessions will take place three times a month for four months in groups of eight     based on age and gender. Caregivers will attend two sessions to support the youth and provide     the guardian perspective on caring for HIV-positive adolescents. The investigator     hypothesizes the mental health intervention will be acceptable, feasible, and will improve     mental health and ART adherence among participating youth and this improvement will be     sustained over time.   "
30364|NCT02888275|"     Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary     profile that makes it an attractive anesthetic for pediatric patients with congenital heart     disease (CHD). The aim of this study was to investigate the renal protective effect of     dexmedetomidine in the perioperative setting in children with heart disease.      Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug     (NoDEX) group.      The primary objective of this study was to assess the relationship between the use of     intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients     undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was     an association between dexmedetomidine use and duration of mechanical ventilation or     cardiovascular ICU stay.   "
30365|NCT02888262|"     This longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a composite     electronic Smartphone-based biomarker and 3) a neurocognitive signature for bipolar disorder   "
30366|NCT02888249|"     The purpose of this study is to determine whether the abuse liability of cigarettes with     altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar,     casings) is reduced relative to standard composition cigarettes.   "
30367|NCT02888236|"     A study of LEO 32731 in the treatment of psoriasis vulgaris   "
30368|NCT02888223|"     Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively     randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or     the alternate sequence (group B). All participants who completed the SCT800HA1 study will     enter the efficacy and safety study (Protocol No.: SCT800HA3).   "
30369|NCT02888210|"     To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes   "
30370|NCT02888197|"     Non-interventional extension study to investigate VVC recurrence and candida colonization     following the P2 acute VVC study   "
30371|NCT02888184|"     The aim of the study is to identify prognostication predictors of 6-months neurological     outcome in survivors at day 3 after cardiac arrest (CA) treated with therapeutic hypothermia     (TH).   "
30372|NCT02888171|"     The main objective of the study is to compare the impact of oral ferric citrate compared to     standard of care oral ferrous sulfate on serum iron, percent transferrin saturation,     ferritin, hepcidin and hemoglobin levels in individuals with moderate to severe chronic     kidney disease (CKD) and absolute iron deficiency.   "
30373|NCT02888158|"     The primary objective of this study is to compare two groups of gynecologic/urologic/visceral     internes in terms of the time required to perform a laparoscopic surgical intervention     (nephrectomy) on an animal model (pig).      The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer     training with robotic assistance versus (2) Pelvic-Trainer training without robotic     assistance.   "
30374|NCT02888145|"     Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have     to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The     main part of the ovary is preserved, as primordial and primary follicles are resistant to     freezing / thawing protocols. In the absence of other techniques (in vivo maturation,     injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is     currently the only technique allowing fertility to be restored. Autograft is possible only if     the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant     pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies,     particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of     any codified technique for evaluating residual disease (MRD). The team has for two years been     developing and validating a technique to look for residual disease in fragments of ovarian     cortex in cases of acute leukemia. This technique is based on an original protocol for     dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be     analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have     been demonstrated in an experimental model. This model consists in using 8 color flow     cytometry to look for characterizable leukemia cells added in different dilutions to a     population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of     10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR with     the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with     polycystic ovary syndrome. The main objective of this project is to validate techniques that     have been previously codified with different populations of leukemia cells that may be     characterized. We then aim to adapt and validate this technique to look for MRD using 8 color     flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are     at risk of metastasis. Secondary objectives will be to implement procedures for oncological     qualification of grafts in cases of malignant pathology and to consider the recommendations     for using this cryopreserved ovarian tissue through the autograft technique for these     indications.   "
30375|NCT02888132|"     Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms,     including progressively increasing fatigue, angina, exertional dyspnea, and syncope.     Conservative medications are used to treat the vast majority of patients. Invasive therapy,     which includes surgical myectomy, septal ethanol ablation and dual-chamber pacing is     introduced to patients with refractory symptoms or drug resistance. Considering the     sternotomy and relatively high patients' tolerance required in myectomy, the potentially     risky misplacement of ethanol and the anatomic variability of the vascularised hypertrophic     septum, and the potential risk of conduction block after these two treatments, the     development of new minimally invasive approach is warranted.      Previous researches have illustrated the effectiveness and feasibility of transcatheter radio     frequency ablation for HOCM patients. By far, there has been no report on transthoracic     laser-induced interstitial thermotherapy (LITT) for human treatment. Since 2004, our     department has adopted High Intensity Focused Ultrasound, radio frequency and laser in solid     tumors treatment, including liver tumors and fibroid. Also our center has conducted several     animal experiments to verify the feasibility of radio frequency/laser in septal myocardium     ablation.      The purpose of this study is to lead echocardiography-guided transthoracic radio     frequency/laser ablation for HOCM ventricular septum, make minimally invasive treatment plans     for HOCM patients, and verify the safety and validity of intervention treatment in long term.   "
30392|NCT02887911|"     The purpose of this study is to characterize adult subjects regarding their history of     allergy and asthma, clinical manifestations of asthma, and exposures and conditions that may     influence asthma severity and control. Assessments include baseline medical history, lung     function tests, questionnaires and collection of specimens for phenotypic characterization.   "
30393|NCT02887898|"     The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type     2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use     of an automated bolus calculator. Additionally, the investigators propose that this     intervention will lead to improvement in patient related outcomes.   "
30394|NCT02887885|"     Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women   "
33595|NCT02846051|"     Compare the frequency of varicose veins in the lower limbs in a population exposed to     intensive sport compared to individuals matched by sex, age and body mass index (BMI) did not     have an intensive sport.   "
30378|NCT02888093|"     Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the     correction of female pelvic organ prolapse. The original description of this procedure     included the use of permanent sutures. However, permanent suture use in this vaginal     application can result in some minor complication such as persistent vaginal spotting,     vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized     delayed-absorbable sutures in order to avoid these complications. Retrospective studies are     conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as     permanent suture. There are currently no high-quality, prospective studies that have     evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.      This study will recruit women scheduled to undergo USLS with or without other prolapse or     anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable     suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome     will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month     follow up visit. Subjects and assessors will be blinded.   "
30379|NCT02888080|"     The purpose of this study is to assess if ACZ885 will improve lung function in association     with reduction of tissue inflammation in patients with chronic sarcoidosis.   "
30381|NCT02888054|"     This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose     Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy     Adult Subjects   "
30382|NCT02888041|"     According perinatal surveys, induction of labor is performed at more than 20% of pregnant     women.      According to a survey on the trigger practices in France, prostaglandins are widely used to     initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®).      The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal     deliveries.      Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin     (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone     limits the use of oxytocin (Syntocinon®) or in lower doses.      Using a second Propess® is carried out in several maternity hospitals, as reported by the     survey on the cervical ripening practices in France. This second administration could be the     solution to reduce the rate of caesarean in France which amounted to 20.8%.   "
30383|NCT02888028|"     This study investigates whether an additional remote follow-up of patients with implantable     cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of     anxiety and depression and device acceptance. Patients are randomized to either conventional     in-office FU only or additional remote surveillance, follow-up duration is 12 months. The     influence of other variables (age, sex,..) is evaluated regarding their influence on study     endpoints.   "
30384|NCT02888015|"     Pt will be provided with a upper extremity exercise program that will be completed daily     during their session with occupational therapy. During the session the Activity Measure-Post     Acute Care and an activity tolerance chart will be completed. The data from the outcome     measures will be used to determine if there is a benefit to completing a daily exercise     program.   "
30385|NCT02888002|"     A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association     with an outpatient addictions clinic.   "
30386|NCT02887989|"     The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control     sham intervention for a broad and representative group of medical and surgical patients     with pain. Hospitalized patients will receive specialized VR interventions, administered via     portable VR headsets, to manage breakthrough pain. Control patients will view content on the     in-room Health and Wellness television channel. Investigators will follow patients throughout     the course of their hospitalization and monitor outcomes during and after their stays,     including pain levels, medication requests, and quality of life.   "
30387|NCT02887976|"     An Open-label extension (OLE), expanded access study, to assess long-term safety of     SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in     patients who completed study number CHL-AA-201.   "
30388|NCT02887963|"     The purpose of this study is to know the prevalence of iron deficiency (ID) and iron     deficiency anemia (IDA) among pregnant women in Chinese urban district at present, and to     analyze the epidemiological characteristics of ID/IDA and influencing factors.   "
30389|NCT02887950|"     For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an     important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus,     hypertension and cardiovascular disease), and several studies have shown that the transition     to menopause is associated with adverse changes in body composition. In particular, it is     common to observe the accumulation of adipose tissue in the abdominal region which is     believed to be an important determinant of the increase in cardiovascular risk.      The first-line strategy for weight management in overweight / obese subjects is the     modification of dietary habits and lifestyle in terms of physical activity. However,     nowadays, there is also a growing interest in complementary therapies (i.e. herbal     supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more     consistent results. In this context, preliminary evidence supports the potential role of some     compounds of vegetal origin such as resistant starch, epigallocatechin gallate and     chlorogenic acid as adjuvants of dietary therapy for overweight.      These nutrients may be an important therapeutic aid for overweight subjects. However, in     support of their use, the evidence from good quality trials is limited.   "
30390|NCT02887937|"     The overarching goal of the proposed research is to evaluate whether qualitative and     quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing     suspicious indeterminate cystic appearing breast masses and ultimately determine whether or     not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses     (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by     ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic     lesions can be followed and do not need biopsy intervention.   "
31167|NCT02877797|"     Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper     GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and     evaluation of the papilla duodeni major.   "
33728|NCT02844322|"     The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone     combined with rituximab or bortezomib regimens in newly diagnosed Waldenström     macroglobulinemia patients.   "
30395|NCT02887872|"     Objective: To explore the effectiveness of a combined neuromuscular electrical stimulation     (ES) and dynamic hand orthosis (DHO) regimen used with a small group of persons with chronic     stroke in improving ability to perform daily tasks. Method: Four participants with chronic     stroke participated in the combined ES-DHO regimen using the affected upper extremity (UE)     five times (5X) per week for 6 weeks. Outcome measures included grip strength, range of     motion (ROM), and analysis of muscle activation/deactivation during release of grasp through     electromyography (EMG). Ability to perform daily functional tasks was assessed using the     Assessment of Motor and Process Skills (AMPS). Results: Preliminary results suggest that     improvements in strength, ROM and grasp deactivation are possible with the combined ES-DHO     regimen. Ability to perform daily functional tasks improved in all participants. Conclusion:     Results should be interpreted cautiously due to the pilot nature of the study and small     participant number. Further research in this area is warranted.   "
30396|NCT02887859|"     This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when     surgically implanted into a leg to improve blood flow in patients with peripheral arterial     disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.   "
30397|NCT02887846|"     Purpose is to show that HHHFNC method is as effective and safe as nCPAPand even more     comfortable than it as non-invasive respiratory support for the prevention of extubation     failure in preterm with gestational age of 26-32 weeks.      Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days     will be included in the study.When patients were Fi O2 < 0,40, Pa CO2 < 65 mmHg, pH> 7.20,     MAP (mean airway pressure) <7 cm H2O, they will be extubated if statistically     stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure     will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is<0.30 at 24 hours     and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2     < 0.30 at 24 hours and above, free oxygen will be introduced.   "
30398|NCT02887833|"     If cancer spreads to bones it can be very painful, especially when trying to move around. One     of the best treatments is radiotherapy, which has to be given in a cancer centre. Even with     this treatment, only about half of people will get good pain relief, and that can take up to     6 weeks to work fully. If we know who is unlikely to benefit , then we can explore other     forms of pain relief sooner, without having to go through radiotherapy unnecessarily.      We have found that there may be a very simple way to identify patients likely to get good     pain relief, using a test of changes in temperature sensation over the painful bone. This     study will explore whether this simple bedside test can be used in a community setting to     identify which patients suffering from cancer induced bone pain will get good pain relief     from radiotherapy.   "
30399|NCT02887820|"     This is a pilot study that seeks to evaluate the feasibility and safety of using a TEG     algorithm in addition to traditional laboratory tests to guide transfusion and coagulation     management of ECMO patients.   "
30400|NCT02887807|"     Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of     these patients remains poor with significant mortality and severe neurological sequelae in     survivors.      The objective of the present study is to determine whether cyclosporine can improve patient     clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre,     randomized, placebo-controlled study. They will receive one single injection of cyclosporine     (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality,     irreversible brain damage informations such as bilateral abolition of N20 wave or absent     motor response or extension to the nociceptive stimulation…) will be assessed 7 days after     CA.   "
30401|NCT02887794|"     Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the     population worldwide. Although pathophysiology of this disease remains unclear, a growing     interest is emerging for low-level sensory function, acknowledging that deficits in early     stages of sensory processing are related to higher-order cognitive disturbances in     schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were     found correlated with disabilities to discriminate psychoacoustic parameters of sounds.   "
30402|NCT02887781|"     This study aims to investigate the factors (clinical, care-related and genetic) affecting     renal outcome in patients with TSC (Tuberous sclerosis complex)   "
30403|NCT02887768|"     Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label,     non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart     adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and     subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair     with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial     performance. This study will interrogate epicardial infarct repair in patients undergoing     coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial     infarction as an adjunct to surgical revascularization. Patients will be evaluated for     markers of cardiac function and left ventricular remodelling using cardiac magnetic resonance     imaging (MRI). Adverse events will be monitored to ensure safety.   "
31207|NCT02877277|"     This study evaluates whether vitamin C improves responses to epigenetic therapy with DNMTis.     Half of the patients will receive vitamin C and DNMTi while the other half will receive     placebo and DNMTi.   "
30404|NCT02887755|"     The purpose of this study is to test a low cost, non-invasive, wearable near-infrared     spectroscopy (NIRS) sensor, previously validated for able-bodied athletes as a rehabilitation     aid for war-fighters with lower extremity limb loss. This sensor can record real-time     physiologic data that relates to total fitness capacity and exertion levels and may help     develop individualized programs on a per-patient basis. The uniqueness of this NIRS     measurement system is that it provides real-time muscular oxygenation, dehydration, and iron     status during whole-body exercise, as well as training-induced adaptations. Currently, no     technology like this has been tested in an amputee population. Successfully validating this     technology in a wounded warrior population would provide vital information regarding tissue     perfusion after injury and new opportunities for improving rehabilitation outcomes.   "
30405|NCT02887742|"     Epidemiologic Study and Impact Study of a Dialysis Solution Change on the     Electrocardiographic Profile of Patient   "
34015|NCT02840539|"     The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone     are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3     lines of previous treatment.   "
30408|NCT02887703|"     This study evaluates the effectiveness of a 12-week in home balance training program with and     without sensory augmentation for individuals with ataxia. Subjects wear a belt while     performing balance exercises three times per week for 12 weeks. The belt measures body motion     and has small vibrating elements called tactors mounted inside that when turned on, feel like     a cell phone set to vibrate. The tactors provide information about body motion and indicate     when and how to make a postural correction. Subjects will receive six weeks of balance     training with the tactors turned on and six weeks of balance training with the tactors turned     off.   "
30409|NCT02887690|"     The purpose of this study is to optimize the Defense Advanced Research Projects Agency's     (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the     performance, usability, and patient acceptance of the MPL in a clinical setting. This study     will be a non-randomized limited clinical optimization study. The study will consist of two     phases. Up to twenty-four upper extremity amputees will be recruited in order to ensure     twelve subjects for participation in the study: 6 trans-humeral amputees and 6 trans-radial     amputees. During Phase 1, subjects will be evaluated for their potential to operate the MPL     using a virtual limb controlled by signals from surface electromyograms (sEMG). The first six     trans-humeral amputee subjects and the first six trans-radial amputee subjects with a     demonstrated proficiency controlling the MPL based on analytical performance metrics will     enter Phase 2. During Phase 2, each subject will be fitted for the prosthesis with a custom     socket. The user will then evaluate the prosthesis during twelve 1- hour or 1 and one     half-hour sessions, working with an occupational therapist and research associates and     completing both quantitative and qualitative assessments.   "
30410|NCT02887677|"     This study is designed to test the hypothesis that the treatment-induced reductions in the     ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the     group of placebo.      It is a 12 week, double-blind, randomized, placebo-controlled clinical trial of dapagliflozin     versus placebo in 160 adult patients with type 2 diabetes mellitus (DM). It will be conducted     in three centers.      Potentially eligible patients will be asked to provide written informed consent (Screening     Visit). Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit     the sites one week (Visit 1 - V1) after the screening visit. On Visit 2 (V2) all eligible     patients will be randomized to one of the two treatment arms and will continue with the next     visits as appropriate (Visit 3, Telephone Visit 1, Visit 4-end of study).      Aortic blood pressure (BP) and arterial stiffness parameters will be measured as indicated by     the protocol in V1 and V3 with the Mobil-O-Graph monitor.      Blood samples will be collected as indicated by the protocol in Screening Visit for the     measurement of glycated hemoglobin (HbA1c), creatinine and liver function parameters. In     addition, blood samples will be collected in V1 and V3 for routine hematological and     biochemical tests including creatinine, fasting glucose, HbA1c, lipid profile and liver     function parameters.      Urine samples will be collected as indicated by the protocol in V1 and V3 for the measurement     of albumin to creatinine ratio.   "
30411|NCT02887664|"     Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy     and lactation for the prevention of preterm birth, beneficial effects on fetal development,     visual and cognitive development and other functional outcomes of the infants.      The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty acid     and inflammation markers in SGA infants compared with appropriate for gestational age (AGA)     infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid     concentrations in cord blood will differ from those observed in AGA and might correlate with     the level of circulating mediators.   "
30412|NCT02887651|"     The purpose of this study is to determine whether a local fractionated radiation therapy     achieves a better local tumor control after complete surgical metastases resection at 6 month     as compared to observation alone. Further it should be evaluated if cognitive functioning and     quality of life is similar in both groups.   "
30424|NCT02887495|"     The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers     use clinical data and human biospecimens to investigate why scleroderma patients develop     certain complications from their disease. Patients with confirmed scleroderma, raynauds or     positive autoantibodies are invited to participate. This research may help us understand how     to prevent and treat scleroderma and other diseases.   "
30425|NCT02887482|"     The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.     GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. This is a Phase 1     clinical trial of this vaccine which encodes for the premembrane-membrane and envelope     regions of Zika virus.      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South     America, Central America, and the Caribbean islands commencing in late 2014 or early 2015.     Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in     adults and microcephaly and other birth defects among children born to mothers who are     infected during pregnancy. At present no vaccines or treatments have been approved for Zika     virus infection.   "
30413|NCT02887638|"     Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic     headache, is seriously hampered because of common features and complex interaction of the     neurological and musculoskeletal system. Current therapies are therefore not as effective and     the population of patients with PRH keeps on increasing. The diagnostic as well as the     therapeutic process need more structure in order to select the most effective treatment;     thereby contributing to preventive measures. This goal can be achieved through fundamental     research with a clinically oriented background. Our study starts from a clinical problem,     with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to     play an important role in PRH, the first step in the diagnostic process is to analyse     postural differences between a PRH- and a control-group. In addition, the role of the dura     mater in the headache-process will be examined. Patients with PRH will be classified in     homogeneous groups based on these results. In a second phase individual-specific treatment     programs will be composed. The general treatment-approach of postural abnormalities in the     past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal     problems has been proven to be successful in the past (O'Sullivan & Dankaerts, non-specific     low back pain).      Our study is divided in 2 phases:        -  phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic          controls)        -  phase 2: interventional phase (clustered headache-groups, based on the results of phase          1   "
30415|NCT02887612|"     Gastric cancer is one of the common malignant tumors in China, with relatively high incident     rate and mortality among the population. Surgery is the conventional treatment option for     early and intermediate-stage stage gastric cancer, but postoperative relapse is the major     issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of     166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is     reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new     biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring.     The present clinical trial aims to elucidate the correlation between the serum ctDNA status     and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical     treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index     to predict postoperative relapse.   "
30416|NCT02887599|"     Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in     the world. This is due to high recurrent rate after surgical resection and poor response to     chemotherapy and radiotherapy.      Recent studies revealed that peri-tumoral structure and patients' immune status including     cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While     past studies focused on oncogenes and tumor suppressor genes, recent studies focused on     patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated     to cancer progression and metastasis.      Natural killer cells, playing an important role in cytotoxic immune system, are revealed to     be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal     cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer     progression and metastasis were accelerated.      This study sought to find the correlation of patients' cytotoxic immune status to cancer     progression and status by measurement of NK cell activity in pancreatic cancer patients. This     would be basic support to construct a prognostic model of pancreatic cancer for early     metastasis and post operational recurrence.   "
30417|NCT02887586|"     Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It     plays an important role in improving the quality of life among advanced cancer patients.     Through a randomized controlled single blinded clinical research, we will observe the     differences of appetite, food intake amount, weight and KPS between the auricular needling     treating group and control group before and after the treatment. Based on the results of the     research, we can prove the clinical effectiveness of auricular needling in treating cancer     induced anorexia and possible mechanism of the method.   "
30418|NCT02887573|"     Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages     of no requirement for sedation and air insufflation.The bowel preparation has a closely     relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean     the colon but also to promote capsule propulsion.Now there is not an optimal method for CCE.   "
30419|NCT02887560|"     The aim of the study is to describe the early adaptation of the right ventricle assessed by     echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.      Secondary objectives include change of haemodynamics measured by transpulmonary     thermodilution and evolution of right heart function in terms of primary graft dysfunction     grading.   "
30421|NCT02887534|"     A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three     dose levels in patients with acute low back pain   "
30422|NCT02887521|"     This is a study funded by the National Institute of Health. The rationale for the need of     this research is the lack of any well proven risk-reducing intervention that may decrease the     morbidity of lung cancer resection in patients with COPD or that may improve their quality of     life trajectory, a meaningful outcome in the overall disease progression. The proposed     intervention is unique as it combines exercise and behavioral interventions that were pilot     tested in a randomized single-blinded controlled design in the proposed population and proved     feasible and potentially effective. The aim is to test the effect of the proposed     rehabilitation on length of stay, pulmonary complications and quality of life trajectory.   "
30423|NCT02887508|"     The goal of this study was to empirically test a newly developed online HIV sexual risk     reduction intervention (HINTS) among a representative sample of gay and bisexual men living     with HIV who meet sex partners online.   "
30426|NCT02887469|"     This study will investigate efficacy and safety of rapid intermittent correction compared     with slow continuous correction with hypertonic saline in patient with moderately severe or     severe symptomatic severe hyponatremia   "
30427|NCT02887456|"     The maintenance of primary teeth until their exfoliation has been one of the main purposes of     Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the     permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous     teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to     conduct a randomized clinical trial is to evaluate the performance of endodontic treatment in     primary teeth using MTA paste, comparing to Vitapex.   "
30428|NCT02887443|"     This phase I open label study is conducted to assess the potential pharmacokinetic     interaction of Raxone® with midazolam in healthy male volunteers   "
30429|NCT02887430|"     The aim of this study was to investigate whether the eight therapy session with foot     reflexology can reduce pain intensity when applied as an addition to the standards care of     low back pain according to the Malaysian low back pain management guidelines.   "
30430|NCT02887417|"     Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the     most frequent immune cells in glioblastoma are tumor associated macrophages, which find     theirself in an anti-inflammatory (M2) phenotype.      Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory     status.   "
30431|NCT02887404|"     Investigators plan to study the role of spine surgery analgesic pathways - for procedures     with high risk of postoperative pain - in improving the quality of recovery   "
30520|NCT02886234|"     This study will investigate whether phone-delivered mindfulness training is feasible and     acceptable for persons living with HIV and whether it may help them improve adherence to     medications and reduce risky sexual behaviors.   "
30738|NCT02883387|"     This study will Investigate whether or not preoperative computed tomography (CT) angiography     will lower operative times and post operative complications for breast reconstruction     performed with a deep inferior epigastric artery perforator flap (DIEP).   "
30432|NCT02887391|"     Although hemodialysis is life-saving, unfortunately, people on dialysis often have declining     health, quality of life as well as poor nutritional status. Hemodialysis patients must follow     a very restrictive diet, and many patients do not eat well and usually report poor appetites.     A new approach to dialysis is being used in some hospitals in Alberta and elsewhere, called     in-centre nocturnal hemodialysis. This in-centre nocturnal dialysis allows people to receive     their dialysis at a hospital or clinic while they sleep. Since this in-centre nocturnal     dialysis gives people 8-hour hemodialysis treatment 3 times per week (24 hours of dialysis     per week) the patients have better removal of the waste products from their bodies than     conventional hemodialysis (an average of 12 hours per week). Also of importance, when using     in-centre nocturnal dialysis, people will have more time during the day to work, spend with     family, as well as have time to shop for food, to cook and even to eat, which in turn will     likely result in improvement in the quality of their lives. This study will follow 10     patients on conventional dialysis and 10 patients on in-centre nocturnal dialysis for 6     months and compare their food intake, muscle mass, weight, body mass index (BMI) and     nutrition-related lab tests. The purpose of this study is to determine whether there is an     improvement in the nutritional status of the in-centre nocturnal hemodialysis patients     compared to the nutritional status of conventional hemodialysis patients.   "
30433|NCT02887378|"     A cross-over study of the impact of histologic results of bronchial biopsies performed using     hot clamps compared to bronchial biopsies using standard clamps   "
30434|NCT02887365|"     Investigators would like to assess the efficacy and safety of tegafur-uracil in patients with     stage II MSI-L or MSS colon cancer under metronomic setting for one year.   "
30435|NCT02887352|"     Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially     executive functions. The California Card Sorting Task (CCST) assesses specific components of     problem-solving ability. There is currently no French version of this test. Reims     neurological department in collaboration with Rothschild Foundation has developed a French     adaptation of CCST. This version includes three cards packages with two alternate forms to     control practice effects (test-retest). In order to assess test-retest reliability we have     to verify the comparability of the three cards packages within one session in MS patients.   "
30436|NCT02887339|"     The Ethical, Legal and Social Issues Substudy in relation to the Genotype Tissue Expression     Project (GTEx) aims to describe tissue requesters' approach to discussions about donation to     GTEx and to assess the determinants of families' and patients' willingness to donate to GTEx.     It also explores ethical issues such as privacy, risks, and release of incidental findings     and recommend best practices for conducting authorizations and training requesters.   "
30437|NCT02887326|"     The biomarker study adds to our previous study on biomarkers in tear fluid. In this study the     investigators examine wether the biomarker levels are in correlation with the disease level     and duration of disease.      The questionnaire study focuses on the patients perspective. With a validated questionnaire     fore keratoconus patient it examine the patients self.-evaluated visual challenges and     quality of life   "
30438|NCT02887313|"     Preoperative 5FU based chemoradiotherapy is still the standard of treatment for locally     advanced rectal cancer. About 15-20% of patients would achieve pathologic complete response     (pCR) after neoadjuvant CRT, and the survival outcome was much better than that of non-pCR.     We aimed to enhance the neoadjuvant treatment, adding mFOLFOX6 during CRT and after     radiotherapy, to improve the pathologic outcome and the survival outcome.   "
30439|NCT02887300|"     Work in a healthcare setting, such as in an emergency department (ED), while rewarding, can     be harmful to psychological well being, as demonstrated by the high numbers of Irish hospital     doctors experiencing burnout. Burnout has been linked to poor healthcare quality, medical     errors and low patient satisfaction. To prevent further escalation of this problem, there is     a need for effective stress-reducing intervention, such as meditation. Meditation practice     has a confirmed positive effect on well being; through greater insight and awareness,     meditation could help ED staff to become more attentive to and understanding of their     patients' complaints, enhancing patient satisfaction and safety. However, based on current     research it is difficult to distinguish between the effects of meditation on well being and     those associated with bringing people together. There is therefore a need for a larger     randomised study (RCT) including a participants that receive no meditation intervention.      This pilot study aims to examine the suitability of RCT to assess the effect of mantra     meditation on burnout among ED staff. The investigators will also examine participant     recruitment and retention, data management and outcomes assessment methods for well being,     patient satisfaction and biological markers. There will be two groups: intervention group     (meditation) and control group (non-meditation). 30 ED staff placed in the intervention group     will discuss prescribed texts and learn mantra meditation over a 7-week period, accompanied     by 20 minutes of daily meditation practice. 30 ED staff placed in the control group will work     in the ED as usual and not receive any texts. Biological samples and questionnaires will be     obtained at three time points. Participant feedback will also be sought through interviews.     This study will highlight issues related to participant recruitment, retention, and     adherence, questionnaires, logistics, and data management and pave the way for an efficient,     effective, and larger study that will investigate mantra meditation as a means of reducing     burnout in ED staff.   "
30440|NCT02887287|"     The study aimed to prove EEN is effective for inducing early clinical remission, mucosal     healing, promoting fistula closure and reducing the size of abscess to adult CD patients.     They plan to include about 50 patients and observe the effect of EEN.   "
30441|NCT02887274|"     Persistence of a marked compensatory anti-inflammatory innate immune response after an insult     is termed immunoparalysis. There is no biomarker available to determine the immune status of     patient. Thus, the need for early and definite diagnosis of immune status of patient with     sepsis, as well as the identification of patients at risk of evolving with severe organ     dysfunctions, is crucial.      Most important of all, speed is the key to survival. Therefore, it of crucial importance to     identify which patient characteristic determines the poor prognosis. Early intervention can     improve the prognosis. Investigators foresee an urgent need to identify predictors for     mortality in severe sepsis, including clinical factors or immune status. Recently, the PIRO     model has been proposed as a way of stratifying septic patients according to their     Predisposing condition, the severity of Infection, the Response to therapy and the degree of     Organ dysfunction. The immune status may be associated with above model. However, there is     paucity data addressing this issue. In this study, investigators will also analyze the     progression of patient condition during treatment and the associated immune status change. In     the future, Investigators hope the determination of immune status may contribute to this     model of classification rather than just being used as prognostic markers. Despite the     advances in the knowledge of the basic processes that trigger and sustain the systemic     inflammatory response in sepsis, the search for a magic bullet to treat this syndrome has     been frustrating. The incidence of severe sepsis and septic shock still remains quite high,     as does its mortality, which has decreased very little over the past decades.   "
30442|NCT02887261|"     For esophageal cancer patients,chest CT could provide more accurate staging information and     eliminated operation that could not achieve R0 resection such as T4 disease. However, the     variation image quality was usual encountered because of contrast medium was injected via     peripheral vein. Power injectable port could provide a secure vascular access as     administration route for contrast medium via central vein. This could provide higher     intravascular contrast medium concentration and could lead better image quality. This study     divided into two arms, one group planned to receive power injectable port and another     received conventional port. The aim of study was tried to identified the image differences     between different contrast medium administration route and the its survival impact of     esophageal cancer.   "
30443|NCT02887248|"     The purpose of this trial is to determine the benefit of the combination of nab-paclitaxel     plus gemcitabine given for 6 cycles, followed by maintenance nab-paclitaxel alone, in     patients with cisplatin-ineligible or cisplatin-incurable advanced urothelial carcinoma (UC).   "
30444|NCT02887235|"     The purpose of this study is to determine whether medically tailored meals (HDTM) can improve     quality of life for patients with metastatic cancer.   "
30445|NCT02887222|"     Until recently, at Mount Sinai Hospital (MSH), epidural analgesia for labor pain was     delivered with a pump that could only provide continuous infusion of the freezing medication     in combination of pushes of medication activated by the patient, a technique called patient     controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested     that this continuous infusion of medication is not as effective as previously thought, and     suggested that instead of continuous infusion we should use intermittent programmed pushes.     The investigators now have devices that are able to do that. Programmed intermittent epidural     bolus (PIEB) is a new technological advance based on the concept that boluses of freezing     medication in the epidural space are superior to continuous epidural infusion (CEI). Recently     the epidural pumps at MSH were reprogrammed to deliver bolus of medication at regular     intervals (PIEB), in addition to what the patient can deliver herself (PCEA). Studies have     shown that delivering analgesia in this manner prolong the duration of analgesia, reduce     motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and     decrease local anesthetic consumption. The investigators have recently concluded a study at     MSH using PIEB where excellent results were observed. However, in that study, some patients     exhibited higher than necessary sensory blocks. The investigators believe that the technique     can be optimized by using the same interval of the previous study with smaller volumes of the     intermittent boluses. Optimizing the technique, may allow the investigators to be able to     reduce even further the amount of medication used by each patient.      The hypothesis of this study is that there is an optimal volume of the PIEB bolus at a fixed     interval of 40 minutes of 0.0625% bupivacaine plus fentanyl 2mcg/ml that will provide 90% of     women the necessary drug requirements during first stage of labor (EV90), thus avoiding     breakthrough pain and need for PCEA or physician intervention. We hypothesize that this     effective volume will be between 7 and 12 mL (6.6 mg/hr to 11.3 mg/hr of bupivacaine).   "
30446|NCT02887209|"     Insomnia is a problem for approximately 75% of people living with HIV, which is much higher     than the 6% to 10% of people with insomnia in the general population. It is currently unknown     why the rate of insomnia is so high among people living with HIV, and because of this, they     are often excluded from clinical trials examining the usefulness of cognitive behavioural     therapy for insomnia (CBT-I), which is recommended as the first-line treatment for insomnia.     Insomnia is also associated with poorer immune functioning and lower medication adherence.     The purpose of this study is to examine whether CBT-I is useful at reducing insomnia among     people living with HIV, and to examine whether this counselling is safe to provide to this     population. Other purposes are to explore whether reducing insomnia will lead to improved     immune functioning and medication adherence, to collect feedback about people's experiences     receiving CBT-I, to examine which psychological and behavioural factors are associated with     insomnia severity among people living with HIV.   "
30447|NCT02887196|"     Twenty-five women will be followed through their breast cancer treatment. The women will be     asked to provide their opinions and desires for lifestyle intervention at different times     throughout treatment. In addition, basic clinical data will be collected . The primary goal     of this pilot study is to investigate the physical and behavioral changes that occur in     patients receiving treatment for breast cancer.   "
30448|NCT02887183|"     This study is to determine early and more chronic changes in concentrations of biomarkers     related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapyover a     period of 12 months, and correlate these biomarker changes with cardiac remodeling     parameters, patient-reported outcomes and cardiovascular outcomes.   "
30449|NCT02887170|"     Losing contact with adult suicide attempters in the year after the suicide attempt (SA)     increases the risk of recurrence. The situation with adolescents is unknown. Investigators     aimed to determine whether being lost to contact early (LCE) by clinicians is a risk factor     of longterm SA recurrence among adolescents and the associated factors.   "
30476|NCT02886806|"     Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management     based on a combination of several physiological variables (bispectral index [BIS], stroke     volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop     systems (PCLS) in patients undergoing high risk vascular surgery   "
30450|NCT02887157|"     Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its     vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study     utilizes new technology to determine visual and neurological development of very preterm     infants in the intensive care nursery, during a period of rapid growth of the retina, optic     nerve and brain. The long-term goal of this study is to help improve preterm infant health     care via objective bedside imaging and analysis that characterizes early critical indicators     of poor vision, neurological development and ROP, which will rapidly translate to better     early intervention and improved future vision care.   "
30451|NCT02887144|"     The aim of the current Investigation is to evaluate the safety and performance of SenSura     test product 1pc flat and convex light compared with commercial SenSura.   "
30452|NCT02887131|"     The purpose of this study is to describe normal dynamic computed tomography anatomy of hind     foot in inversion/eversion movement, and to define diagnostic criteria for subtalar     instability.   "
30453|NCT02887118|"     Quantitative and prognostic evaluation of dense red blood cells in sickle cell children:     preliminary single center study from the Creteil pediatric cohort.   "
30518|NCT02886260|"     This study aims to:        1. describe the monitoring of patients treated for spinal disorders.        2. create a comprehensive database of reliable and readily exploitable quickly to produce a          library of cross publications between orthopedic surgery and neurosurgical services.          This database will include clinical, functional , radiographic , educational, social and          professional data.        3. obtain a cohort of patients in the comprehensive range of spinal pathologies.        4. standardize data collection in this cohort with similar national projects.   "
30454|NCT02887105|"     The purpose is to determine the relationship between anxiety and cognitive performances in     patients with acute and chronic phases of cerebrovascular accident (CVA). Data from     neuropsychological assessment concerning cognitive processes (working and episodic memory)     sensitive to different dimensions of anxiety will be analyzed.      The secondary purpose is to evaluate how some neurological (hemispherical lateralization of     lesions), psychological (depression) and demographic (quality of life) variables can increase     the effects of different dimensions of anxiety on cognitive processes, during the acute     and/or chronic phase of CVA.   "
30455|NCT02887092|"     Hip and knee osteoarthritis (OA) is an important health problem with a high prevalence and     significant consequences on functional ability, perceived health, restriction of autonomy and     handicap. The weight of multimorbidities and their interaction on functional ability and     perceived health are left unexplored. This project will rely on the cohort KHOALA,     representative, multiregional, of 881 prevalent cases (symptomatic hip and knee OA).      Main objective:        -  to describe the evolution over time of pain, functional ability, social participation          and quality of life in subjects with hip and knee OA        -  to identify prognosis factors of disease evolution (socio-demographic, clinical, and          other health parameters)        -  to determine interactions with comorbidities, other personal and environmental factors          (ICF model).      Concurrent objective: to improve measurement of perceived health specific to hip and knee OA     by the OAKHQOL by improving its metrologic performances based on item response theory.      Task 1: To prepare an improved measurement scale, available as a judgment criteria for the     3rd year of cohort follow up, over the april 2010-march 2012 period, the mini-OAKHQOL Task 2:     Evaluation of the cohort in 2010-2012 (year 3 of follow up) in a repeated measure design to     best assess the evolution of perceived health and functional ability over time, and to     identify stability of deterioration of autonomy. Perspectives: This project targets to     provide public health deciders with information of good quality to help them manage     determinants of perceived health in OA subjects, as essential factors to health care resource     utilization in their various modalities.   "
30456|NCT02887079|"     EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in     infective endocarditis) is a prospective cohort study with a biological collection.      The main objective is: to re-evaluate the potential value of antiphospholipid (aPL)     antibodies as predictors of embolic events in IE in the light of the improved current     knowledge on these aPL.      The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation     markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von     Willebrand factor) will be taken into account in the analysis, and interest in predicting     embolic risk, alone or in combination with aPL will be investigated.   "
30457|NCT02887066|"     The purpose is to build up a data observatory of individuals with thoracic pain evoking acute     coronary syndrome (ACS). The aim is the characterization of this population of patients     consulting at emergency department, the evaluation of therapeutic strategies with regard to     guidelines and the becoming of patients including severe complications and mortality.   "
30458|NCT02887053|"     The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition     parameters.   "
30459|NCT02887040|"     Patients ≥ 3 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma will be     enrolled in this study. However, the primary objectives of this study are to 1) compare     overall survival, the time from randomization to death from any cause, for study subjects     3-21 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma who receive     Antineoplaston therapy (Atengenal + Astugenal) + radiation therapy vs. radiation therapy     alone and 2) describe the toxicity profile (all subjects) for Antineoplaston therapy +     radiation therapy vs. radiation therapy alone.      A secondary objective is to compare progression-free survival for study subjects 3-21 years     of age with newly-diagnosed, diffuse, intrinsic pontine glioma treated with Antineoplaston     therapy + radiation therapy vs. radiation therapy alone.   "
30460|NCT02887027|"     Multiple studies indicate that exercise is effective in treating depressed mood and reducing     anxiety sensitivity. As depressive symptoms and anxiety sensitivity are elevated in     individuals with anxiety and depressive disorders, exercise could help reduce these symptoms     and aid in the overall treatment of these disorders. This project aims to test an ecological     momentary exercise intervention (Exercise4Mood) delivered via a mobile phone application in     individuals with anxiety or depressive disorders. Previous protocols have tested the     acceptability and usability of Exercise4Mood in healthy participants. In Phase 1 of the     study, focus groups were conducted to explore the acceptability and usability of the     Exercise4Mood app. Qualitative feedback was collected and modifications were made to the app     based on this feedback. In Phase 2 of the study, the Exercise4Mood app was tested in 6     healthy participants. Preliminary unpublished findings indicate that the app was acceptable     and promoted increased physical activity. The aim of this protocol is to test the     acceptability, usability, and efficacy (to improve mood and reduce anxiety) of Exercise4Mood     in patients with anxiety or depressive disorders.   "
30461|NCT02887014|"     To study the impact of providing specific verbal instructions in inpatients (and/or their     relatives) undergoing colonoscopy on the quality of bowel preparation.   "
30462|NCT02887001|"     Incomplete information or poorly communicated to the transitional stages of the patient's     drug therapy hospitalized cause medication errors. These steps are the admission, transfer     within the institution and hospital discharge to home or another institution.      The adequacy of the prescription recommendations of good practice is not always optimal.      The cost of taking drug therapy and iatrogenic risks preventable drug-related weighs more and     more heavily in health spending and in the prolongation of hospitalization or re     hospitalization.      Clinical pharmacy widely practiced in the Anglo-Saxon countries has demonstrated its     effectiveness on these three themes; it seems appropriate to assess this practice in the     environment of the French health system.   "
30521|NCT02886221|"     Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments of     Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion within     the orthopaedic community. The purpose of this longitudinal prospective study was to evaluate     radiographic and functional outcomes in patients with mild-to-severe HV who underwent     Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and lateral release.   "
30463|NCT02886988|"     Linear hypertrophic scar is a common surgical problem that can be difficult to manage,     especially for the median sternotomy scar. Despite high demand for the early intervention to     prevent and treat surgical scars, there is yet no universal consensus on satisfactory     treatment. Botulinum toxin type A is a neurotoxin that has been widely and safely used in     medicine for more than 30 years. It induces chemodenervation through acting on the     presynaptic neuron to prevent release of acetylcholine, which leads to functional denervation     of striated muscle for about 6 months after injection. The aim of this randomized controlled     trial is to evaluate the efficacy of Botulinum toxin type A as a prophylactic treatment in     the early postoperative of median sternotomy for the purpose of preventing excess scar     formation.   "
30464|NCT02886975|"     The purpose of this study is to determine whether low protein diet and very low protein diet     supplemented keto-/amino acid is effective in preventing the progression of chronic kidney     disease (CKD , stage 2 to 5).   "
30465|NCT02886962|"     Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation     whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines     for the hemodialysis patients with atrial fibrillation, the general guidelines apply.     However, several retrospective studies suggest that these patients do not benefit from the     oral anticoagulation regarding the risk of stroke and may even experience more bleedings and     deaths.      The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic     risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients     with atrial fibrillation.   "
30466|NCT02886949|"     This study aims to evaluate the effects of thyroid functions on energy homeostasis and     inflammation.   "
30467|NCT02886936|"     The goal of iFIT Prosthetics, LLC® was to create and commercialize a modular, immediate fit,     fully adjustable, transtibial prosthesis system suitable for mass production using high     strength injection molded polymer materials. This goal was achieved and the aim of this     project is now to conduct a feasibility and effectiveness study and to assess the design of     the device. The investigators will be fitting up to 30 transtibial amputees that are current     prosthesis users with the iFIT device. Patients will wear the device for 2 weeks and evaluate     for comfort, stability and ease of use as compared to their conventional device. The     investigators will also be obtaining socket pressures and gait biomechanics of participants     wearing both devices.   "
30468|NCT02886910|"     This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood     count, blood culture) and clinical observation by standardized physical examination versus     the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical     observation and antibiotic therapy) in the management of asymptomatic infants born at term to     mothers with suspected chorioamnionitis. The primary outcome of the study is the difference     in the prevalence of sepsis-related symptoms between the two groups.   "
30469|NCT02886897|"     Background: Combinations of dendritic and cytokine-induced killer cell (D-CIK) based adoptive     immunotherapy and anti-PD-1 antibody may enhance the immune response and stop cancer cells     from growing.      Objective: Phase II clinical trial to investigate the safety, clinical activity and toxicity     of combinations of D-CIK and anti-PD-1 antibody in patients with treatment-refractory solid     tumors.      Methodology: Phase II clinical trial in patients with advanced metastatic hepatocellular     carcinoma, renal cell carcinoma,bladder cancer,colorectal cancer,non-small-cell lung     cancer,breast cancer and other solid cancers. The D-CIK was isolated from peripheral blood of     participants,then activated,expanded and incubated with anti-PD-1 antibody before infusion.     The enough number (1.0-1.5 *10^10 cells) of D-CIK were infused back into participants.   "
30470|NCT02886884|"     This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via     infusion therapy for diabetic subjects with endothelial dysfunction.   "
30471|NCT02886871|"     The overall goal of this study is to test personalized mobile phone-based physical activity     interventions among staff members at the University of California, Berkeley. Most physical     fitness applications for smartphones and activity trackers use a constant goal for the number     of steps each day. However, if the step goals are dynamically adjusted according to past     behavior, then the corresponding goals may encourage individuals to increase their physical     activity level. This study consists of a randomized controlled trial in which we are     assessing the efficacy of two different algorithms for calculating personalized goals for the     number of steps each day.   "
30472|NCT02886858|"     While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates     and cognitive side effects limit its long-term use. There is no consensus about optimal     continuation pharmacological treatments after a ECT course.      Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse     rates.   "
30473|NCT02886845|"     The purpose of this study is to determine the frequency of two Single Nucleotide     Polymorphisms (SNPs) by sanger-sequencing in Breast Cancers and healthy controls .   "
30474|NCT02886832|"     The purpose of this study is to assess the efficacy of a Prostate Health formulation on     scores attained from the I-PSS questionnaire. Safety and tolerability of the formulation will     also be assessed.   "
30475|NCT02886819|"     Aim: Hypothesis of this study was that WBV activates different receptors or reflex pathways     depend on vibration intensity. Aim of this study was to test this hypothesis.      Methods: This study was conducted on 11 healthy adults. WBV was applied at various     frequencies and amplitudes. The right soleus T-reflex latency was determined before and     during WBV. WBV-IMR latency of the right soleus was determined using two different vibration     intensity: weak vibration and powerful vibration. T-reflex latency and WBV-IMR latency were     determined by using cumulated average method.   "
30488|NCT02886650|"     When focal epilepsies become drug-resistant, it could be eligible for cortical surgical     resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during     presurgical evaluation. Some of these children can have access to thermocoagulation inside     the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These     thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical     lesions around the electrodes. The aim is to stop or at least, to reduce the seizure     frequency for few weeks or months. This could be a benefit for the child, and also a     confirmation of the ictal onset zone and guide the surgeon. This technique is currently used     in adult population for years, but remains very rare in children.   "
30477|NCT02886793|"     Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension     (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently,     pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been     adequately characterized due to the lack of markers. A better understanding of the mechanisms     that regulate this proliferative disorder will allow the identification of new therapeutic     targets for HP.      The objective of the project is to identify cell proliferative processes in severe forms of     PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo     characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs)     analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs     and the right ventricle between patients and controls.   "
30478|NCT02886780|"     Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and     response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland     University hospital has developed a concentrated 4-day treatment format which has been     evaluated as part of standard care. Next step in the methodological development is to conduct     a randomized controlled trial where the 4-day format is compared to self-help and waiting     list. The study will be conducted at Solvang DPS, Sørlandet Hospital. Participants (16 in     each group) are ordinary patients (>18 yrs) entitled to care in the specialist health care.   "
30479|NCT02886767|"     This study examines the effect of skin-to-skin contact between father and newborn on the     father-neonate attachment relationship. By block randomization, participants were allocated     to an experimental (n=41) or a control group (n=42).   "
30480|NCT02886754|"     Importance: Clinical communication is an important source of medical error and preventable     adverse events.      Objective: To determine the effectiveness of proficiency-based progression (PBP) simulation     training for ISBAR (Identify, Situation, Background, Assessment, Recommendation)     communication in the deteriorating patient.      Setting: The study will be conducted in University College Cork, Ireland. Participants: Third     year undergraduate nursing and fifth year medical students, who are scheduled to undertake     ISBAR training as part of the National Early Warning Score (NEWS) programme.      Intervention: Participants will be prospectively randomized to one of three groups before     undertaking a performance assessment of an ISBAR communication relevant to a deteriorating     patient in a high fidelity simulation laboratory: HSE group (the national e-learning     programme only); S group (national e- learning plus simulation training) and PBP group     (national e-learning plus proficiency-based progression simulation).      Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication     in the context of an acutely deteriorating patient.   "
30481|NCT02886741|"     In 2011, IHI designed a new campaign to accelerate uptake of evidence-based practices that     had been shown to prevent surgical site infections (SSI) associated with hip and knee     arthroplasty. Project JOINTS (Joining Organizations IN Tackling SSIs was a multi-faceted,     disciplined initiative that used the Rapid Spread Network (defined above), methods and tools     developed during previous IHI campaigns to influence orthopedic practices and hospitals     performing hip and knee arthroplasty. Rather than launch nationally as other campaigns have     done, Project JOINTS was introduced in a cluster-randomized fashion to enable a rigorous,     independent evaluation of its effectiveness in promoting uptake of new evidence-based     practices.   "
30482|NCT02886728|"     The primary objective of this study is to evaluate the effects of filgotinib in combination     with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).   "
30483|NCT02886715|"     A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing     Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a     Vehicle Control in the Treatment of Acne Vulgaris   "
30484|NCT02886702|"     A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing     Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a     Vehicle Control in the Treatment of Stable Plaque Psoriasis   "
30485|NCT02886689|"     C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory     rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic     juvenile arthritis, established under the auspices of national health authorities.      Its goal is to document safety, effectiveness in routine practice of various therapy,     including biotherapy, of prescription or non-prescription over 5 years.      A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI >     4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will     be possible to have patients non exposed to biotherapy (non indication, refusal,     contraindication) compared to patients exposed to biotherapy, and to monitor adverse events     occurrence as well as effectiveness in routine practice over time, according to prescription,     maintenance or switch of various therapies.   "
30486|NCT02886676|"     Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.      It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC)     exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and     leukotriene biosynthesis.      Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary     antioxidants level in CP subjects.      Materials And Methods- The study was a randomized double-blind clinical and biochemical trial     in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of     Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group     (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1     month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG.     Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at     baseline, 1 month & 3 months.   "
30487|NCT02886663|"     This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic     patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke     (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the     cerebral localization and in 60% of stroke interesting the territory of the posterior     cerebral artery.   "
30503|NCT02886455|"     The study investigates the impact real output has on peristomal skin covered by a newly     developed adhesive and a standard adhesive.   "
30504|NCT02886442|"     This study investigates the impact of real output on the adhesion of two adhesives.   "
30496|NCT02886546|"     Robot-assisted laparoscopic prostatectomy (RALP) is widely performed due to its many     advantages, including a reduced need for blood transfusion and fewer surgical complications     compared with conventional open prostatectomy. As this approach is also recommended in     elderly patients with serious comorbidities, optimal fluid therapy guidance during this     procedure is important.      Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV)     are used to predict and guide fluid therapy during controlled ventilation. These variables     arise from heart-lung interactions during positive pressure ventilation, which influence left     ventricular stroke volume (SV). RALP requires carbon dioxide insufflation and the steep     Trendelenburg position to optimise surgical conditions, and can reduce cardiac output and     respiratory compliance. Accordingly, the usefulness of PPV and SVV, which are affected by     changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic     surgery under these conditions may be questioned. A recent study established that PPV and SVV     derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict     fluid responsiveness during laparoscopy on dynamic preload indices. In contrast, another     study SVV measured by oesophageal Doppler monitor (ODM) could predict fluid responsiveness     during laparoscopic surgery.      The CardioQ-ODM+ combines the proven ODM Doppler measurement of blood flow with pulse contour     analysis, which is quickly and easily calibrated from the Doppler signal. We hypothesized     that PPV and SVV measured by calibrated pulse contour analysis would be a good indicator of     fluid responsiveness during laparoscopy with pneumoperitoneum.      The primary objective of this study was to demonstrate that PPV and SVV measured by     calibrated pulse contour analysis of CardioQ-ODM+ can accurately predict fluid responsiveness     during RALP, which involves both pneumoperitoneum and the Trendelenburg position.     Investigators also assessed the capacity of other dynamic variables (SPV [systolic pressure     variation], and SVV determined by ODM Doppler flow, dynamic elastance [PPV/SVV] and corrected     flow time [FTc]) to predict fluid responsiveness during RALP.   "
30497|NCT02886533|"     Prospective, multicenter, observational study with a three-year inclusion period (from     January 1, 2012 to December 31, 2015) and a 6-month follow-up   "
30498|NCT02886520|"     This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF)     and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female     stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the     other half will be operated with PP ones.   "
30499|NCT02886507|"     This is a randomized double-blinded placebo-controlled study to evaluate the effects of     NSK-SD consumption in subjects with Stage I hypertension.      The study population will be randomized into two groups, where both groups will receive     dietary and lifestyle recommendations to help reduce hypertension. One group will receive     placebo and the other group NSK-SD for 8 weeks.      The endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of     treatment in the two subject groups.   "
30500|NCT02886494|"     A Randomized, Double-Blind, Vehicle-Controlled, Parallel, Phase II Study to Evaluate Efficacy     and Safety of BAC in Patient with Alzheimer's Disease or Vascular Dementia   "
30501|NCT02886481|"     Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most     common and most serious complications of thyroid surgery. Neuromonitoring of the inferior     laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to     locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle     which is stimulated electrically at the location of ILN, producing an acoustic and visual     signal. This is a basic electromyographic technique whose diagnostic and prognostic potential     for the entire neuromuscular system has not yet been fully explored. The study of action     potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the     beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis     during the course of surgery making it possible to diagnose lesions of the nerve and guide     the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent     paralysis. It could also enable the surgeon to give a prognosis for functional recovery.   "
30502|NCT02886468|"     Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.     Although there are several causes of fatal anaphylaxis, food allergy is one of the most     common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A     delay in epinephrine administration may contribute to an increased risk of death. Therefore,     the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine     solution be administered intramuscularly in the mid-anterolateral thigh.      In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight> 30 kg,     the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the     weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and     Jext®.      Several studies suggest that the needle length needle is sometim   "
30505|NCT02886429|"     Postoperative pain is the most undesired consequence of surgery, and if not managed     adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to     reveal that postoperative pain is insufficiently managed throughout the first world, let     alone in the Third World. An American survey over 20 years showed that only one in four     patients had adequate relief of postoperative pain. This has led recovery room protocols to     include pain as a fifth vital sign that needs to be addressed before patients are discharged     to the ward   "
30506|NCT02886416|"     The objective is to characterize the viral evolution and viral factors determining HIV     virulence, the evolution of the HIV reservoir in PBMC and the co-evolution of anti-HIV CD8 T     cell repertoires. The coordinated study of virus evolution, host responses and identification     of genetic determinants of virulence should allow to better understand mechanisms of HIV     pathogenicity and persistence of mutations in viral reservoirs.   "
30507|NCT02886403|"     The study investigates the impact real output has on the adhesion of adhesives.   "
30508|NCT02886390|"     The purpose of this study is to determine whether remote limb ischemic conditioning(RIC)     increase the risk of intracranial hemorrhage for the acute ischemic stroke patients who     received r-tPA thrombolytic therapy.   "
30509|NCT02886377|"     To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked     po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis     (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort.   "
30519|NCT02886247|"     The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the     investigators are interested in both the genetic and non-genetic causes of pancreatic cancer.     The investigators are particularly interested in finding the genes that cause pancreatic     cancer to cluster in some families. Up to 10% of pancreatic cancer patients have another     close relative who has also developed pancreatic cancer. This clustering of pancreatic     cancers in families has yet to be explained; however, the investigators continue to identify     new familial pancreatic cancer genes that explain this clustering in subsets of families. For     example, in 2009 and 2012 the investigators discovered that mutations in the PALB2 and ATM     genes jointly account up to 5% of the clustering of pancreatic cancer in families.   "
30510|NCT02886364|"     The purpose of this mixed methods study is to evaluate the implementation of an adapted Safe     Childbirth Checklist in a rural hospital in Chiapas, Mexico. The study aims are:        1. To evaluate the implementation of the adapted Safe Childbirth Checklist using quality of          care indicators and the perspectives of providers and patients;        2. To examine changes in the perceptions of disrespectful and respectful practices around          childbirth among providers before and after a quality improvement program.        3. To understand how postpartum women and their male partners perceive the care they          received at the hospitals in Ángel Albino Corzo and Revolución with regard to          disrespectful and respectful practices, and how, if at all, these experiences compare          with prior birth experiences in other settings.        4. To examine trends in proportion of facility-based births in the catchment area of the          hospital after the implementation of the adapted Safe Childbirth Checklist   "
30511|NCT02886351|"     The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In     concentrations up to 50% it is considered as mild sedation and it is very safe. Despite its     safety and widespread of its use nitrous oxide is not a potent drug and many times dentists     fail to gain cooperation in moderate or high anxious children, and the alternatives are to     use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Higher     concentration was not conducted in Pediatry densitery. The aim of this study is to compare     the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70%     with 50% parameters, sedation depth, adverse events and cooperation of the child during the     dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to     70% is a safe and effective sedation method in dental treatment of children.   "
30512|NCT02886338|"     External control of capsule endoscopy (CE) by means of an applied magnetic field is a     possible way to maneuver the movement of CE in gastrointestinal (GI) tract. The aim of this     study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule     endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum     in healthy subjects.   "
30513|NCT02886325|"     The overall goal is to develop a culturally appropriate and easy to disseminate educational     intervention documented to improve cancer prevention and increase cancer screening behaviors     in the rural Midwest.   "
30514|NCT02886312|"     This study will evaluate patient comfort and oxygen delivery efficiency when providing     supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen     delivery system. The goals of the study are to evaluate different oxygen flow rates and     oxygen delivery modes. In addition, the investigators will investigate if the system can     detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators     will also investigate how well high flow oxygen delivered only during inspiration is     tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow     delivered only during the inhalation phase of the breath.   "
30515|NCT02886299|"     Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg     (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their     dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density     lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were     compared before and after 16-week treatment.   "
30516|NCT02886286|"     The purpose of this study is to determine whether the local anesthetic bupivacaine delivered     intrathecally in small doses via PTM self-administered boluses significantly improves the     breakthrough pain and functional status of patients with chronic intractable pain who are     managed with an intrathecal drug delivery system.   "
30526|NCT02886156|"     Multiple clinical studies have indicated that obstructive sleep apnea (OSA), the most common     chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous     positive airway pressure (CPAP) has some neurocognitive protective effects against the     adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture     and function remain unclear. Therefore, this multicenter trial was designed to investigate     whether and when neurocognitive architecture and function in patients with OSA can be     improved by CPAP treatment, and to explore the role of gut microbiota in improving     neurocognitive function during treatment.This study will be a multicenter, randomized,     controlled trial with allocation concealment and assessor blinding. A total of 148 eligible     patients with severe OSA will be enrolled from five sleep centers, and randomized to receive     CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive     function, structure and function of brain regions, gut microbiota, metabolites, biochemical     variables, electrocardiography, echocardiography, pulmonary function, and arterial stiffness     will be assessed at baseline before randomization and at 3, 6, and 12 months. In addition,     the investigators will enroll 74 healthy controls and assess all of the aforementioned     variables at baseline.   "
30517|NCT02886273|"     Sudden cardiac death (SCD) accounts for approximately 15 percent of the total mortality in     industrialized countries, and most commonly results from cardiac arrest due to ventricular     fibrillation (VF). VF can appear both with identifiable heart disease and as an idiopathic     arrhythmia. The most commonly underlying heart disease associated with out-of-hospital     cardiac arrest (OHCA) is coronary artery disease (CAD).      In this study the investigators intend to give a thorough description of the study population     based on demographic data, clinical information, medical history and biochemical parameters.     The investigators plan to assess the total number of OHCA cases among patients reported to     the ambulance service in the local region during the study period, and determine the     proportion with documented VF. Next the investigators need to evaluate the clinical baseline     profile of those included in the study as compared to that of the total VF population. High     sensitivity cardiac Troponin T cTnT) and brain natriuretic peptide (BNP) will be added to the     baseline data for further classification of the included SCA patients.      The main aim of the study will be to evaluate the diagnostic value of copeptin in the setting     of sudden cardiac arrest (SCA).      As a second aim the investigators intend to evaluate the association between VF and the     content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in red blood cells.      Furthermore, as vitamin D is associated with n-3 fatty polyunsaturated acids (n-3 PUFAs) in     the diet, the third aim will be to assess the association between 25-hydroxy (OH)-vitamin D     and VF. Matched MI patients will be selected for comparison.   "
30522|NCT02886208|"     This study is a collaboration between investigators and two community partners: a youth     employment program and an urban farm. The community partners hire 300+ adolescents for summer     jobs at various organizations. Approximately 120 adolescents will be employed with the urban     farm site. As one component of their program evaluation plan, investigators will evaluate     change in BMI of participants. The investigators hypothesize that there will be a reduction     in BMI of those participants working at the urban farm site.   "
30523|NCT02886195|"     The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor     Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential     treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor     Receptor)-mutant non-small-cell lung cancer (NSCLC).   "
30524|NCT02886182|"     To date, several studies have manifested that high levels of adrenal corticosteroids and     oestrogen hormones during pregnancy can lead to increased HBV viraemia. These hormonal and     immune function status changes can result in minimal fluctuations in liver function tests.     Serum alanine aminotransferase (ALT) tends to increase in late pregnancy and the postpartum     period. Peripartum hepatitis flares leading to hepatic decompensation have been     reported.Therefore, the investigators aim to detect and observe the immune function status     and incidence of hepatitis in pregnant women with chronic hepatitis B virus infection in late     pregnancy and the postpartum period.To provide a clinical evidence for the administration of     chronic hepatitis B virus infection pregnant women.   "
30525|NCT02886169|"     The postprandial state increases triglyceride-rich lipoproteins and lipopolysaccharide (LPS)     levels, promoting cellular lipids accumulation, insulin resistance, increased inflammatory     markers and the formation of foam cells, a situation that can have different effects     depending the type of dietary fat and presence of metabolic conditions such as abdominal     obesity and insulin resistance.      Given that the diet of the Colombian population is rich in saturated fats, and taking into     consideration the general resistance to complex dietary changes, the purpose of this study is     to evaluate whether Sacha Inchi oil supplementation of a high-fat meal is effective in     reducing levels of biochemical markers of cardiovascular risk in adults with and without     abdominal obesity.   "
30527|NCT02886143|"     Urinary retention is a common problem, particularly in hospitalized patients. When a Foley     catheter is removed, a patient must be monitored for urinary retention. The usual method is a     passive voiding trial where the catheter is removed, the bladder fills with urine and the     patient is monitored for voiding over approximately 6 hours. Another option is an active     voiding trial where the bladder is filled with saline before the catheter is removed and the     patient is immediately assisted to void. This study seeks to determine the effect of active     vs passive voiding trials on time to hospital discharge, rate of urinary tract infections,     and rate or urinary retention in the general hospitalized population.   "
30528|NCT02886130|"     In order to attain the elite level on the national scene, volleyball players need several     attributes. In addition to mastering technical and tactical skills, great jumping ability is     another important asset. Maximal power output needed to achieve height during a jump     necessitates coordinated neuromuscular recruitment and muscle mass among others.     Interestingly, there are claims that alpha-glycerylphosphorylcholine (A-GPC) increases     acetylcholine synthesis and enhances exercise-induced increases in plasma growth hormone     concentrations, two factors that could theoretically be associated neuromuscular transmission     and muscle mass.      However, until now only a few studies have investigated the role of A-GPC in human exercise     performance. Published results were mixed. One recent study showed that isometric peak force     was slightly but significantly increased when subjects had ingested a daily dose of 600 mg of     A-GPC over a period of 6 days (Bellar et al., JISSN, 2015).      The objective of our study is to evaluate the longer-term effects (4 weeks) using a higher     dose (1000 mg/day) of A-GPC on jumping capabilities in elite male and female volleyball     players.   "
30529|NCT02886117|"     The main objective of this study is to determine the capacity of a questionnaire to predict a     normal balance sheet of haemostasis.   "
30530|NCT02886104|"     The surgical and local ablation strategy for the treatment of resectable synchronous and     metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of     this study is to compare two treatment strategies in which simultaneous resection of both     primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous     CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in     SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and survival.   "
30531|NCT02886091|"     Treatment of keloids scars is difficult and controversial. These keloids have a functional     and aesthetic impact. A lot of treatment are described with a lot of relapses and     aggravation. Authors report outcomes of the treatment with shaving and cryosurgery   "
30532|NCT02886078|"     The primary objective is to investigate the active extension six months after implantation of     the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.      This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex     arthroplasty.   "
30533|NCT02886065|"     This research study is studying a targeted therapy as a possible treatment for Smoldering     Multiple Myeloma.      The following intervention will be involved in this study:        -  Lenalidomide        -  Durvalumab        -  PVX-410   "
30534|NCT02886052|"     The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy     (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist     guided ICBT or to an active control who receives written information on sleep, insomnia, and     sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment     compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to     evaluate changes in symptoms of complicated grief and depression.   "
30535|NCT02886039|"     Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to     50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity :     50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount. The     American Academy of Neurology identifies accurate predictors of poor neurologic outcome (2):     clinical examination findings such as no pupil response, no corneal reflexes, no motor     response to stimulation and early myoclonus status epilepticus; biologic parameters like high     neuron specific enolase (NSE) greater than 33 μg/L (3-4) and electrophysiologic results like     flat electroencephalogram (EEG) or with burst suppression and Somatosensory evoked potentials     (SEP) with no response to N20. Brain imaging may provide additional informations but not     recommended yet. However, these pronotic markers were developed before the introduction     therapeutic hypothermia (TH) (5-6). TH is now recommended after cardiac arrest by     international guidelines, based on demonstration of improved survival and neurological     recovery in comatose survivors of CA (7). TH and its associated use of sedative and paralytic     agent may delay neurologic recovery and affect the optimal timing of prognostic variables     (8).      Many classifications of electroencephalogram (EEG) (9-12) exist but no one is generally     accept and recommended and they were created before TH.      In a preliminary study based on a retrospective cohort of 64 patients in CA with initial TH,     we developped an electroencephalographic score to predict precocity the neurologic outcome     according to the Cerebral performance category (CPC) (13-14).      The purpose of this study is to evaluate a simple and objective electroencephalographic score     helpful to predict neurologic outcome after CA. Then, we would like to create a composite     score to have a multimodal prognostication.      Patients and methods After CA resuscitation, all patients underwent coronary angioplasty if     indicated and then were immediately admitted in emergency room of ICU. All patients were     intubated and mechanically ventilated. Sedation was performed with continuous infusion of     midazolam 0,15-0,2 mg/kg/h and sufentanil 0,15-0,2 μg/kg/h. All our patients were curarized     with cisatracurium 0,2-0,3 mg/kg/h to prevent shivering during TH and took anti-epileptic     medication phenobarbital 10-15 mg/ kg two times a day to prevent infra-clinic convulsive     seizure.      Mild TH between 33 -34 °C was performed by active cooling with intravascular device     (CoolGard® - Zoll, Chelmsford, UK) for 24 hours. Mean arterial pressure was maintained     between [75-80] mmHg by titrated norepinephrine with or without inotropics (dobutamine,     epinephrine) according cardiac output monitored by echocardiography.      After 24 hours of hypothermia, warming was started at a rate of 0.2 ° C/hr; neuromuscular     blocking agents were arrested at 35.5°C and sedation at 36.5°C.      Neurological evaluation performed at 48 hours off sedation included a clinical evaluation     (Glasgow score, myoclonus status, response to orders, motor response to stimulation,     brain-stem reflexes). NSE was sampled between 48 and 72 H. EEGs were performed at Day-2,     Day-3 and Day-5 off sedation and SEP at Day-5 off sedation. All EEGs were interpreted by two     certified electroencephalographers blind from clinical neurologic outcome.      Survival and neurologic outcome according to CPC were assessed at ICU discharge and three     months later.   "
30536|NCT02886026|"     This study compare the efficacy of conventional photodynamic (PDD) guided transurethral     bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction     of bladder tumors through flexible cystoscopes.   "
30740|NCT02883361|"     The proposed research is a randomized controlled investigation of the efficacy of     motivational interviewing (MI) to improve adherence to aromatase inhibitors (AI) in a     community sample of patients with poor adherence to AIs.   "
30537|NCT02886013|"     Background and Aims: The presence of the FTO rs9939609 and PPARy rs1801282 polymorphisms     suggests changes in energy metabolism; this variation may be responsible for the development     of various diseases including obesity. The aim of this study was to identify the presence of     these polymorphisms in Mexican adolescents with overweight and obesity at high risk for     developing diabetes. Methods and Results: This was a descriptive cross-sectional study, where     71 healthy adolescents (average age of 16) were included. Anthropometric measurements, Body     mass index, as well as the determination of glucose, insulin and HOMA index were calculated     from all the patients. The FTO rs9939609 and PPARy rs1801282 polymorphisms were determined by     real-time PCR.   "
30538|NCT02885987|"     The purpose of this investigator-initiated study is to determine whether the use of an     accessory device called AmplifEYE can improve colonoscopy quality in patients who are     undergoing average risk colorectal cancer screening. Primary end point is adenoma detection     rates.   "
30539|NCT02885974|"     The purpose of this study is to compare patient tumor tissue before and after treatment with     chemotherapy plus celecoxib. Investigators will look at gene expression, to see what effect     celecoxib may have on tumor cells.   "
30540|NCT02885961|"     The pathogenesis of idiopathic pulmonary fibrosis (IPF) is incompletely understood but     recurrent epithelial injury occurs which evokes the coagulation cascade. Thrombin is produced     as a result and is over expressed in IPF patients, so may be important in propagating disease     activity. We aim to recruit patients with IPF and then complete FDG     (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET (positron emission tomography) scans     pre and post manipulation of the coagulation cascade to assess the role of this biological     pathway in disease activity. Previous studies from our institution have demonstrated     increased FDG avidity in the lungs of patients with IPF (assessed using FDG PET scans) but to     date the cells and pathways responsible for this signal have not been identified and thus     need further exploration.   "
30541|NCT02885948|"     This is an investigator led, randomised, double blind, placebo controlled, double arm     comparator study.   "
30542|NCT02885935|"     The investigators examined the effects of 4-week dietary protein intake in mixed meals at two     levels of protein amount on whole body glucose metabolisms in older adults with metabolic     syndrome.   "
30543|NCT02885922|"     Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. In this     study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic     outpatient, who receiving a new anti-diabetic drugs.   "
30544|NCT02885909|"     This study will be conducted in the ward of Taichung Veterans General Hospital. The patient     with hyperglycemia in hospitalization will be enrolled by glucose management team.   "
30577|NCT02885480|"     Describe and analyze routes and modes of care for patients in emergency consultant in various     emergency care and public psychiatric outpatient devices to provide useful information to     optimize trajectories taken into psychiatric load on the Eurométropole territory upstream and     downstream of where they viewed urgently.   "
30545|NCT02885896|"     In order to show that tailored pediatric counselling by telephone can reduce the number of     unscheduled and medically unjustified physicians visits in emergency structures, a randomized     controlled study is conducted. It compares the proportion of cases which used the emergency     services or unscheduled consultation according to whether they received (or not) nurses'     telephone advices from the platform. Indeed, our hypothesis is that the presence of nurses     responding at the Reception and Control Calls Center inside the Emergency Medical Services     (in french : Service d'Aide Médicale d'Urgence SAMU) - whose role is to deliver appropriate     advice to people calling for benign pathologies they see as urgent and to answer questions     following specific recommendations - will reduce the number of unplanned and medically     unjustified consultations in medical emergency structures.      This platform was set-up in order to show it may be a solution in response to the growing     demand for pediatric care from the population, helping to reduce overcrowding in emergency     care facilities. Indeed, promoting home care or only if necessary scheduled consultation     reinforces the conduct to have when facing a pathology from their child. It will also help by     reducing unjustified use of emergency structures, improving not only the users' reception     conditions who actually require support in these structures with less waiting time, but also     the working conditions for employees who perform there.   "
30546|NCT02885883|"     Three groups of patients will be considered: a control group (n = 10); a group of patients     with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will     replace CT-scan usually performed in routine before the procedure (n = 15); a group of     patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with     gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D     gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with     the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution     2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA     relaxation times. Argus software will be used for post-treatment imaging. Quantitative data     will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed     between the three groups. Statistics will be performed with SPSS software in bilateral     analysis and a value of p < 0.05 will be considered as significant.   "
30547|NCT02885870|"     The spinal cord is a common site for the development of several neurodegenerative     neurological disorders (spinal muscular atrophy or SMA, amyotrophic lateral sclerosis or ALS,     X-linked spinal bulbar muscular atrophy or SBMA). In different proportions, these diseases     involve axonal loss in large funiculi of the spinal white matter, their demyelination, and     loss of ventral horn motor neurons or motoneurones of the spinal gray matter. The lack of     specific biomarkers of these macro and microscopic spinal damages, makes it difficult the     differential diagnosis and monitoring of these diseases.      Techniques to explore non-invasively the human central nervous system, such as magnetic     resonance imaging (MRI) and electrophysiology, are potential tools to extract specific     biomarkers of spinal damages. However, imaging techniques are still poorly developed at     spinal level for technical (specific antennas), anatomical (size of the spinal cord,     vertebrae) and physiological reasons (cardio-respiratory movements). However, recent advances     in the field of spinal cord imaging allowed to extract quantitative data on neuron loss,     axonal degeneration and demyelination in different spinal pathologies whether degenerative     (ALS or SMA) or traumatic (SCI). Correlations were found with clinical data, and in ALS     patients, the changes in MRI metrics over time paralleled the functional deterioration. The     electrophysiological techniques are used since a long time, leading to a good knowledge of     the neurophysiology of human spinal cord. In addition, electrophysiology indirectly provides     data at a microscopic scale, providing information on the excitability of spinal neural     networks and giving an estimate of the amount of functional neurons.      By combining these techniques for the investigation of human spinal cord in vivo, the goal is     to extract new biomarkers using as study models, diseases of the spinal cord affecting     differentially the white and the gray matter (SMA, SBMA and ALS).      At first, new methods of diffusion MRI and modelling will be performed in healthy subjects to     assess the axonal density and diameter of the fibers in the white matter. The anatomical     imaging T2 will measure the geometrical parameters of the spinal cord such as its surface     and/or volume at a given vertebral level. Thanks to imaging, we will construct via methods of     segmentation and image processing, an atlas of the spinal cord that will allow to locate     spatially spinal atrophy in patients. After this phase of validation, A study of patients     will be conducted using these new MRI techniques, in addition to those already developed in     the laboratory. The contribution of electrophysiology will be to assess more accurately the     microscopic damage. Quantitative data from imaging and electrophysiology will be correlated     with clinical data in order to extract the most relevant biomarkers.      This project has thus a methodological interest by proposing the development of new methods     to assess the human spinal cord, at both macro and microscopic levels. These methods are     based on the development of the techniques developed at spinal level and which are already     applicable to human pathologies. The original combination of imaging and electrophysiology     will also enable us to further analyze the human spinal cord, both anatomically and     functionally. This project has an important clinical value for the extraction of biomarkers     in diseases where there is an unmet need for diagnosis, monitoring, prognosis and evaluation     of new therapies.   "
30548|NCT02885857|"     Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of     patients with chronic kidney disease.   "
30558|NCT02885727|"     Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is     well tolerated and stimulates a clinically significant pancreas-cancer specific immune     response.      The primary objective will be to evaluate whether the combination of RT and durvalumab can     improve median PFS compared to chemotherapy historical control data in metastatic pancreas     cancer patients who have progressed through first-line chemotherapy.      The primary intent of RT in this study is to augment a pancreatic cancer-specific immune     response when given with durvalumab.   "
30741|NCT02883348|"     Investigating the predictive value of patient satisfaction with care on 6 months and 1-year     quality of life.   "
30742|NCT02883335|"     The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring     in Lorraine a French region, and follow up on them for an indefinite duration, registering     disease evolution and intercurrent events.   "
30549|NCT02885844|"     Parabolic flight is the only ground-based condition in which weightlessness (0G) can be     created long enough for safely testing changes in human perception and behavior. In addition     to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present     another unique opportunity to test the same responses to hypergravity and back to 1G.      Spatial orientation perception is a critical subsystem that is used by the central nervous     system in the control of vehicles and other complex systems in a high-level integrative     function. Evidence from space flight research demonstrates that spatial orientation is     altered by the transitions in gravito-inertial force levels (Clément 2011; Clément & Reschke     2008), transitions corresponding to mission phases particularly critical for crew safety and     mission success. Accurate perception of self-in-space motion and self-motion relative to     other objects is critical for successful operations that involve motor control e.g. doing an     extra-vehicule activity or piloting the spacecraft. To date, there is only limited     operational evidence that these alterations cause functional impacts on mission-critical     operations and control capabilities. Immediately after space flight, most crewmembers have     reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or     other symptoms of motion sickness), and frequently manifested by lack of coordination,     particularly during locomotion The hypothesis is that alteration in sensorimotor performance     induced by inverted vision is gravity depend: maximum alteration during hypergravity,     intermediary alteration during normal gravity, minimal alteration during weightlessness.   "
30550|NCT02885831|"     The aim of this study is to prove the improvement of pubo-femoral distance by early abduction     splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical     stable hip but an abnormal hip ultrasonography).   "
30551|NCT02885818|"     Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential     effects on B cells are not well described. This study will assess the effects of abatacept     therapy on the phenotype and function of peripheral blood B cells in patients with RA.   "
30552|NCT02885805|"     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection     Factor (SPF) on the skin of human subjects.   "
30553|NCT02885792|"     Schizophrenia is a severe mental illness associated with excess mortality and affecting     nearly 1% of the population. The average life expectancy for patients diagnosed with     schizophrenia has been 55-60 years through the last generations in Denmark, while the general     population has over the same period of time experienced an increase in life expectancy. As a     result, the standardized mortality rate for patients with schizophrenia has increased     markedly over the last three decades and is currently a major public health concern. Causes     of death are mainly cardiovascular disease and patients diagnosed with schizophrenia has a     relative risk of cardiovascular disease that is about 2-fold higher than the general     population.   "
30554|NCT02885779|"     The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.      There is however no forward-looking or retrospective study comparing the     microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access     celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section)     in gynecological surgery.      The objective of this preliminary study is to compare both surgical care in terms of     morbidity died operating, in adnexa surgeries.   "
30555|NCT02885766|"     A multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability, safety,     pharmacokinetics and preliminary efficacy of PF-114 for oral administration in adult patients     with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), which is     resistant to the 2-nd generation Bcr-Abl inhibitors or has T315I mutation in the BCR-ABL     gene.   "
30578|NCT02885467|"     This is a randomized study investigating whether identification, ligation, and burial of     superficial branches of the saphenous nerve crossing the surgical field during total knee     arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to     standard total knee arthroplasty.   "
30556|NCT02885753|"     Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from     cancer. Between 30 to 60% of patients develop limited or predominant liver metastases.     Surgical resection of these metastases, only curative treatment is not immediately possible     in 10-15% of cases. In unresectable patients, current palliative treatments are based on     systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab),     anti-VEGF (bevacizumab)). In this patient population, special attention was paid to     intensified treatment regimens in order to improve their efficiency and improving the tumoral     response rate, the intensity of the response and its earliness correlate with improved     overall and progression-free survival.      The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of     64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who     have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits     systemic and especially neurological toxicities, thanks to a greater hepatic clearance.      In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with     oxaliplatin has showed promising efficacy results associated with good tolerance from the     first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close     to 100%, with high response rates associated with early maturity and depth responses as well     as prolonged survival. However, to date, in the absence of randomized trial testing this     combination, this strategy does not have sufficient evidence to be integrated in our routine     practices, and HIAC remains limited to a few expert centers in treatment catch-up.   "
30557|NCT02885740|"     The purpose of this study is to analyze the association of atrial fibrillation onset in     normal heart and:        -  Genetic determinants (genes of receptors, enzymes involved in synthesis and degradation,          genes of bioavailability of coenzymes and nutritional precursors)        -  Metabolic determinants of adenosine and methionine cycles        -  Nutritional determinants.      Secondary purposes are:        -  Analysis of physiopathologic mechanisms of AF in normal hearts and adenosine metabolisms          and its interaction with methionine metabolism, according to identified genetic          determinants        -  Analysis of blood markers of adenosine and methionine metabolites as phenotypic markers          of detected polymorphisms        -  Evaluate the role of adenosine receptors in AF onset   "
30587|NCT02885350|"     In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be     compared when given either intrathecally or epidurally in primiparous parturients during     early phase of the labour.   "
30559|NCT02885714|"     Rotator cuff tear is a very common and disabling condition that can be related to acute     trauma such as falling on the shoulder. A tear is associated with symptoms such as pain in     abduction, abduction weakness and night pain. Rotator cuff tear surgery is a well-established     form of treatment in acute rotator cuff tears, although beneficial results have been reported     for both conservative and surgical treatment of rotator cuff tears. Rotator cuff tear repair     surgery involves a considerable amount of re-ruptures, and it is possible that the repaired     tendon do not heal despite surgical repair. On the other hand rotator cuff tears are also     found in completely asymptomatic persons and the clinical significance of a rupture may be     generally lower than estimated. The above-mentioned factors, as well as recent research and     meta-analysis on the treatment of mainly degenerative rotator cuff tears indicate that there     is a limited evidence that surgery is not more effective in treating symptomatic rotator cuff     tear than conservative treatment alone. However, these previous research findings cannot be     applied directly to traumatic tears, although degeneration can be considered always to     contribute to the creation of a rotator cuff tear.      During few last decades, despite the lack of evidence on the superiority of one treatment     over another, the use of surgery to treat this disorder has been substantially increased.     Treatment expectations are found to be important in predicting patient related outcome     measures. In addition, surgery itself may produce a profound placebo effect. There are no     previous placebo-controlled trials on the topic of interest. In order to find out the true     efficacy of surgical treatment of acute, trauma related rotator cuff tears involving mainly     the supraspinatus tendon, the investigators have designed this multi-centre, randomized,     placebo-controlled efficacy trial.   "
30560|NCT02885701|"     The purpose of this study is to determine if any difference exists among 3 different     postoperative splinting regimens- no splint, removable splint, and plaster non-removable     splint- following mini-open carpal tunnel release (CTR) surgery.   "
30561|NCT02885688|"     The goal of this clinical research study is to learn if adding liquid nutrition therapy that     is given by vein to standard-of-care treatment for sepsis can help to control sepsis symptoms     better than giving standard-of-care treatment alone.      Researchers also want to compare the length of ICU and hospital stay and any side effects     between these 2 treatments.   "
30562|NCT02885675|"     To evaluate the correlation between the value of miRNA related to ARDS and vascular     endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in     patients with ARDS.   "
30563|NCT02885662|"     To examine antihypertensive effect and safety of CS-3150 in patients with primary     aldosteronism.   "
30564|NCT02885649|"     This pilot phase 0 trial studies how well enzalutamide works before surgery in treating     patients with kidney cancer. Androgens are a type of hormone produced by the body that may     cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the     amount of androgens produced by the body and keep kidney tumors from growing.   "
30579|NCT02885454|"     The purpose of this study is to evaluate the effect of steady-state concentrations of     odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA)     ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and     ethinylestradiol in healthy female participants.   "
30580|NCT02885441|"     Patients with acute pancreatitis will be randomly assigned in either study group to receive     oral Ketorolac or control group (double blind study).   "
30581|NCT02885428|"     The pathophysiological features of myocardial diabetic subject combined with cardiac     autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent     myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the     sudden onset of a myocardial infarction, or even sudden death.      That is why the investigators want to evaluate the contribution of non-invasive tools to     stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map:     Technical myocardial speckle tracking in studying strains overall average left ventricular     (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress     echocardiography with dobutamine (ESD)   "
30582|NCT02885415|"     the troponin level and ECGs pre and post operative will be used to determined prevalence of     myocardial injury among patients undergoing gastrointestinal surgery   "
30565|NCT02885636|"     The enormous and rapidly growing burden of Heart Failure with Preserved Ejection Fraction     (HFpEF) has led to a need to understand the pathogenesis and treatment options for this     morbid disease. Recent research from the investigator's group and others have shown that     pulmonary hypertension (PH) is highly prevalent in HFpEF, and right ventricular (RV)     dysfunction is present in both early and advanced stages of HFpEF.      These abnormalities in the RV and pulmonary vasculature are coupled with limitations in     pulmonary vasodilation during exercise. There are no therapies directly targeted at the     pulmonary vasculature that have been clearly shown to be effective in HFpEF. A recent study     by Mayo Clinic Investigators has demonstrated pulmonary vasodilation with dobutamine (a beta     2 agonist) in HFpEF. As an intravenous therapy, this is not feasible for outpatient use.      In the proposed randomized, placebo-controlled double blinded trial, the investigators seek     to evaluate whether the commonly used inhaled bronchodilator albuterol (a beta 2 agonist),     administered through a high-efficiency nebulizer device that achieves true alveolar drug     delivery, improves pulmonary vascular resistance (PVR) at rest and during exercise in     patients with HFpEF as compared to placebo. This has the potential to lead to a simple cost     effective intervention to improve symptoms in HFpEF, and potentially be tested in other World     Health Organization (WHO) Pulmonary Hypertension groups. PVR is an excellent surrogate marker     for pulmonary vasodilation and has been used in previous early trials of PH therapy.   "
30566|NCT02885623|"     This study evaluates the clinical significance of CX3CR1-expressing myeloid and lymphoid     cells in patients of hematologic malignancy.      Tumor cells either express membrane molecules or release tumor-derived soluble factors able     to alter myelopoiesis and lymphopoiesis. Myeloid cells expressing CD11b play a critical role     in sustaining cancer progression. Also, the fractalkine (CX3CL1; Fkn)/CX3CR1 axis plays an     important function in the pathophysiology of various forms of cancers. Fkn is the only known     ligand for CX3CR1, and it triggers recruitment of CX3CR1-positive cells through its unique     receptor, CX3CR1. Therefore, the investigators focused the prognostic significance of CD11b+     myelo-monocytic cells expressing CX3CR1 and CD3+ lymphoid cells expressing CX3CR1 in the     clinical outcomes of newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) and Multiple     myeloma (MM).   "
30567|NCT02885610|"     The purpose of this study is to initially access the safety and effectivity of RC18 combined     with standard treatment and Placebo combined with standard therapy in subjects with Moderate     to severe SLE, Besides ,to provide dose basis for follow-up clinical trials.   "
30568|NCT02885597|"     The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are     effective in the treatment of active Rheumatoid Arthritis (RA).   "
30569|NCT02885584|"     High frequency percussive ventilation (HFPV) is a high frequency ventilation mode in which     high frequency pulses accumulate to generate a low frequency tidal volume at a controlled     airway pressure. Previous studies have suggested a protective effect of HFPV on lung injury.     The goal of our study is to compare, in early ARDS patients, the effects of conventional     mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment     and distension evaluated by CT-scan   "
30570|NCT02885571|"     This study evaluates whether objective compliance monitoring can increase mandibular     advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of     participants will be assigned to objective compliance monitoring group (experimental group),     while the other will be assigned to subjective compliance monitoring group (control group). A     physician will prescribe and explain to patients based on data from objective or subjective     compliance monitoring.   "
30571|NCT02885558|"     The purpose of this study is to examine the role of T-type calcium channels in endothelial     dysfunction observed with ageing.   "
30572|NCT02885545|"     Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at high     risk for stroke. The use of blood thinking medication in dialysis patients is controversial     and warfarin carries a serious risk for major bleeding.      The Watchman device may be an ideal therapy for this population as after implantation it     allows for the discontinuation of blood thinners, thereby reducing the risk of bleeding.   "
30573|NCT02885532|"     The ability to meaningfully consent intoxicated and chemically dependent patients for     research has inhibited medical advances in this vulnerable population. A recent pilot     supported use of the University of California, San Diego Brief Assessment of Capacity to     Consent tool to assess the capacity of intoxicated emergency department patients to     participate in research. The objective is to determine the number of intoxicated emergency     department patients who could correctly complete the questionnaire, and evaluate alcohol     concentration, sedation and ability to recall participation upon sobriety.   "
30574|NCT02885519|"     The purpose of this study is to investigate the efficacy of 1) a stepped mental health care     (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR)     intervention for people on sick leave because of burnout, adjustment disorder and     psychological stress in Denmark   "
30575|NCT02885506|"     The First in Human (FIH) study is separated into two parts:        -  The first part is a Single Ascending Dose (SAD), double-blinded, randomized and          placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).        -  The second part is a food effect cohort with an open-labelled, randomized fed/fasted          cross-over design.      The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics     (PK) of P218 in healthy volunteers.   "
30576|NCT02885493|"     The strong relationship between falling and severity of cognitive impairment in the elderly     is well established. The association premorbid gait and executive disorders suggests that     they are under tension by the same mechanisms. The gait fortiori neurological are fall risk     factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are     subcortical origin involving so the basal ganglia. This study is indeed based on the     assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes     resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the     contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with     cognitive impairment and greater susceptibility to confusional states. The executive     disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye     movements, impaired vision contrasts are well established in the degenerative parkinsonian     syndromes. This study proposes a new approach to assessing gait disorders to define a high     risk of falling in the presence of parkinsonian walking in the elderly over 75 years.   "
30583|NCT02885402|"     Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an     infection or an inflammatory process that affects millions of people. The first symptoms     usually appear from 40-50 years and at this point, conventional radiological tests provide     diagnostic elements relatively late, poorly correlated with pain relief and providing no     functional information. In this context, there is a real need for imaging techniques for     early detection of osteoarthritic changes in a still reversible stage for faster support and     MRI appears to be the tool of choice.      Conventional proton MRI sequences already allow improved detection possibilities compared to     conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient     to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to     recent technological advances, exploration MRI other nuclei such as sodium is now possible.     Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and     ultimately a gradation osteoarthritic reached.      This project's main objective is to quantify the biochemical changes (sodium content)     occurring at different stages of osteoarthritis defined by clinical algofunctional scores     (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).   "
30584|NCT02885389|"     Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters     with an onset in the first year of life. West syndrome represents a subset of ISs that     associates spasms in clusters, a hypsarrhythmia EEG pattern and a developmental arrest or     regression. Aetiology of ISs is widely heterogeneous including many genetic causes. Many     patients, however, remain without etiological diagnosis, which is critical for prognostic     purpose and genetic counselling. In the present study, the investigators performed genetic     screening of 73 patients with different types of ISs by array-CGH and molecular analysis of 5     genes: CDKL5, STXBP1, KCNQ2, and GRIN2A, whose mutations cause different types of epileptic     encephalopathies, including ISs, as well as MAGI2, which was suggested to be related to a     subset of ISs.   "
30585|NCT02885376|"     The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in     reducing the severity of oral mucositis secondary to radiation therapy for head and neck     cancer.   "
30586|NCT02885363|"     The main objective of this study is to clarify prospectively prognosis of patients newly     diagnosed as carriers of a LVNC (incident cases) (i.e. without the occurrence of a survival     of the following events: death, heart transplantation or hospitalization for cardiovascular     complications). In a second time, prognosis factors will be identify in these patients with     LVNC.   "
30588|NCT02885337|"     Osteoarthritis leads to reduced independence and quality of life. Total hip replacement is a     successful and cost-effective surgical intervention to relieve pain and improve functioning     in patients with osteoarthritis. Research has shown that pre-operative health status strongly     predicts outcomes including physical function and hospitalization length after hip     replacement surgery. Frail patients, in particular, are at greater risk of poor     post-operative outcomes and could potentially benefit from interventions targeting an     improvement in their health status prior to undergoing a hip replacement surgery. Partnering     with Young Men's Christian Association (YMCA) and a multi-disciplinary team of healthcare     providers, this pilot trial will examine the feasibility of a multi-modal intervention for     frail patients that includes a supervised exercise program, vitamin D and protein     supplementation, and a medication review. The results of this feasibility study will guide     the design of a future multi-center study, which if successful, could be developed into a     routine model of care that is implemented in joint replacement programs across Ontario and     ultimately improving the lives of frail seniors undergoing hip replacement.   "
30589|NCT02885324|"     This pilot will study the feasibility and exploratory efficacy of using Cabozantinib for     recurrent or refractory high grade glioma for which there are no curative options. Patients     will also be followed for safety, time to progression, event free survival and overall     survival   "
30590|NCT02885311|"     The purpose of this research study is to develop and test a care model to treat excessive     drinking and alcohol use disorders in the primary care setting. The goal of this research     study is to increase the identification and treatment of problem drinking in the primary care     setting. Individuals will be asked to participate in this study because routine screening and     assessment conducted at your primary care clinic indicates that you have recently exceeded     healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.   "
30591|NCT02885298|"     Endotracheal intubation is most commonly taught and performed with the patient supine. Recent     literature suggests that elevating the patient's head to a more upright position may decrease     peri-intubation complications. However, there is little data on success rates of upright     intubation in the emergency department. The goal of this study was to measure the association     of head positioning with intubation success rates among emergency medicine residents.   "
30592|NCT02885285|"     The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and     depression in Parkinson's disease. It is well established that exercise improves the motor     symptoms of Parkinson's disease. However, it is not clear which types of exercise are most     beneficial for specific non-motor symptoms.   "
30593|NCT02885272|"     The goal of this clinical research study is to compare the results during different scanning     time points after a contrast drug is given for a FDG PET/CT. The contrast drug helps the     researchers see the images more clearly.   "
30594|NCT02885259|"     Subcutaneous immunoglobulin (SCIG) and recombinant human hyaluronidase (rHuPH20) will be     tested in patient witch MMN and currently under maintenance treatment with IVIG for safety,     tolerability and efficacy.   "
30595|NCT02885246|"     The purpose of this study is to assess the prevalence, strain circulation and disease burden     of seasonal Influenza A and B in Panama, selected countries of Central America and the     Caribbean from the Year 2010 to 2015.   "
30596|NCT02885233|"     This study evaluates the effectiveness of a web-based fall prevention program called Free     From Falls Online (FFFO) on people with multiple sclerosis.   "
30597|NCT02885220|"     The aim of our study is to determine if the goal directed weight loss program improves weight     loss versus the conventional weight loss program after laparoscopic sleeve gastrectomy.   "
30598|NCT02885207|"     The knowledge of encephalitis associated with antibodies targeting intracellular antigens,     and neuronal surface antibody syndromes has expanded considerably in recent times.      The primary purpose of the investigators protocole is to determine the incidence of     anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal     epilepsy of unknown cause to guide the management of these patients.      The investigators hypothesis is that dysimmune encephalitis is more common than is suggested     by the current literature, and that sometimes forms of encephalitis dysimmune at minimum     can be observed only in the form of focal epilepsy without further manifestation associated.   "
30599|NCT02885194|"     Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly     understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS)     could make a profit on the pain in PD.      The investigator would drive a study with a follow up of PD patients before and after     STN-DBS. The pain will be clinically explored by targeted questionnaires and     electrophysiological through laser evoked potentials.      The questionnaires are designed to quantify and characterize the pain in these patients.     Laser evoked potentials will, through repetitive stimulation, study both the functional     status of the afferent nociceptive pathways, their habituation to repetitive nociceptive     stimuli, and so better understand any abnormalities of the central processing of nociceptive     information.   "
30600|NCT02885181|"     The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for     the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active     RA despite methotrexate (MTX) therapy who had an inadequate response to MTX (either alone or     in combination with biological disease modifying anti-rheumatic drugs [bDMARDs]).   "
30601|NCT02885168|"     The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated     with dose-response curve is diminished in septic shock and ameliorated by activated protein C     (APC).      This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen     species (ROS) markers and increase of circulating catecholamines.   "
30611|NCT02885038|"     Platelet concentrates (PCs) characteristics, such as storage duration, ABO compatibility,     dose and source, may have an impact on transfusion responses and outcomes. Because of the     relative scarcity of PCs the selection of a specific PC for issue to the patient remains a     challenging process. Regulatory agencies do not fully address these characteristics in their     recommendations for prophylactic transfusions.      The aim of the study was to analyse the effect of product-related factors in a real life     setting, in order to determine which ones are the most relevant when selecting PCs for     patients in prophylactic conditions. Two different endpoints are studied: the corrected count     increment and the platelet transfusion time intervals.   "
30602|NCT02885155|"     The purpose of this study is to determine the prognostic value of echocardiographic     parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial     hypertension (PAH).      A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months. In     pulmonary fibrosis it has been demonstrated that the variation of clinical and paraclinical     parameters between 2 examinations has a prognostic interest. In this study the prognostic     value of variation of some echocardiographic parameters between initial examination and     echocardiography after 3 or 6 months will be evaluated.      Another secondary purpose is to create a common database for Pneumology, Cardiology and     Epidemiology departments with prospective registration of new cases of PAH and follow of     patients under treatment.   "
30603|NCT02885142|"     Local excision for early rectal cancer has proven its feasibility and oncological safety.     Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal carcinomas     respectively. Two procedures are currently performed in these early cancers as well as in     preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven its     superiority over traditional transanal excision, is a surgical approach associated with a 92%     R0 excision rate, a survival comparable to radical anterior resection and a low morbidity. It     consists of a full-thickness excision. The second procedure is a recently introduced     technique: the endoscopic submucosal dissection (ESD), which encompasses only the mucosa and     submucosa. ESD enables endoscopists to achieve higher en bloc resection rates than standard     mucosectomy and is associated with a 88% R0 resection rate, which decreases to 65% in the     subgroup of European series. Though very promising, the role of ESD remains controversial in     malignant lesions with few published reports. There are therefore 2 different techniques with     2 different dissections (full-thickness vs. submucosal) to achieve the same oncological     treatment. So far, only one retrospective single-center study including 63 patients has     compared TEM and ESD in early rectal cancer without finding any difference between the 2     procedures, and there are no other available studies comparing TEM and ESD for any type of     colorectal tumor. The aim of the present research is to compare ESD with TEM for early rectal     cancer and rectal adenomas for short- and long-term outcomes.   "
30604|NCT02885129|"     The main objective is to assess the measurement characteristics (validity, reproducibility)     and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology     and rheumatology hospital and liberal and hospital oncology and Infectious disease, by     following the evolution of patient compliance at D0 and D15.      The second objective is to assess the sensitivity to change of scale EGOMAC following     developments compliance 3 months.   "
30605|NCT02885116|"     In this study effect of NHF on pulmonary thermodynamic parameters will studied.   "
30606|NCT02885103|"     This study will prove to concept of effectiveness of NHF in combination with a nebulizer on     reversibility of lung function in COPD patients.   "
30607|NCT02885090|"     Rett syndrome (RTT) is a genetic encephalopathy and the typical form is caused by mutations     in the gene MECP2. It is a genetically heterogeneous pathology. CDKL5 and FOXG1 have been     recently discovered being involved in other forms of RTT. However, at least 5% of typical     forms and more other atypical forms are not linked to any of 3 genes known to be involved in     the disease.      The purpose of this study is to identify new genes involved in molecular etiology of typical     and atypical forms of RTT.   "
30619|NCT02884934|"     Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked     venous thromboembolism have a high risk of recurrence after stopping anticoagulations.     Extending anticoagulant therapy for an additional 18 months is associated with a major     reduction of recurrent VTE; however this benefit tended to be lost after stopping     anticoagulation during a follow-up period of two years. This risk of recurrentce is likely to     continuously increase over the years as well as the risk of chronic thromboembolic pulmonary     hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep     vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these risks over 6     years of follow-up in patients who have been initially treated during 6 months or 24 months     (patients included in the PADIS PE and PADIS DVT trial).   "
31239|NCT02876861|"     The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin     (GC) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the     overall survival for high-grade upper tract urothelial carcinoma.   "
30608|NCT02885077|"     Even with the advances in clinical therapy and percutaneous interventions, coronary artery     bypass grafting (CABG) is still widely used in the treatment of patients with coronary artery     disease (CAD). However, it is a complex procedure that triggers important organic     implications especially on pulmonary function. In relation to the treatment of patients     undergoing CABG, the recovery is linked to the cardiac rehabilitation programs. These     programs can also be associated with other muscle training measures, among these there is     inspiratory muscle training (IMT). Most studies has been implemented moderate-intensity IMT     daily, but there are few studies about the effects of high intensity training loads performed     on alternate days. In this context, is justified the use of a device such as the recent     Powerbreathe, which uses higher training loads that would provide greatest benefits, whereas     the magnitude of the response to training tends to increase with load.      OBJECTIVE: To investigate the efficiency of high intensity IMT associated with combined     aerobic and resistance training on maximal exercise capacity, submaximal exercise capacity,     respiratory muscle strenght, pulmonary function, oxidative stress, quality of life and     endothelial function in patients who underwent CABG in phase II cardiac rehabilitation     program.      METHODOLOGY: This is a clinical trials, controlled, randomized,double-blind being developed     in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria (HUSM), Santa     Maria, RS, Brazil. Patients will undergo the evaluation of pulmonary function and respiratory     muscle strength (spirometry and digital manovacuometry), as well on the maximal exercise     capacity (Ergospirometry), submaximal functional capacity (6MWT and 6MST), of quality of live     (MLHFQ) of Oxidative stress and endothelial function (blood biomarkers). After the evaluation     will be randomly allocated into two groups: the control group will perform cardiac     rehabilitation associated with the Sham of IMT, and the experimental group cardiac     rehabilitation associated with the IMT High-intensity. The intervention will last twelve     weeks for both groups and after this phase patients will be submitted again to the assessment     tools.      EXPECTED RESULTS: The high intensity IMT potentiates the effects of cardiac rehabilitation     (phase II) after coronary artery bypass surgery patients.   "
30609|NCT02885064|"     This study is observational only and is intended to evaluate changes in the makeup and     function of bacteria naturally present in the mouth during treatment with braces to     straighten teeth.   "
30610|NCT02885051|"     The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain     Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).   "
30900|NCT02881281|"     Adolescence is the most important period of growth for humans. The conflict and disagreement     which exists within family relationships will affect the children behaviors. Family     relationships are the cause of many problems in adolescents, to develop a training program on     problem-solving skills for adolescent girls to change their relationship with their parents.   "
30612|NCT02885025|"     Allergic rhinitis is a common illness suffered among US Veterans. There are medications that     help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some     patients have increase symptoms with exposure to their trigger, such as a grasses when     combined with pollution due to oxidative stress from pollution. In this study, patients with     allergic rhinitis to grass will be given broccoli sprout extract that contains an antioxidant     sulforaphane do see if there is beneficial effect in these patients.   "
30613|NCT02885012|"     The purpose of this study is to learn more about the safety and effects of switching     treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24     weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension     (CTD-PAH).   "
30614|NCT02884999|"     This cohort study describes the epidemiology of trauma patients and their management in a     French academic trauma center. It also aims to determine what recommendations from the     European trauma guidelines is applied in routine.   "
30615|NCT02884986|"     Acute pain is the result of activating nociceptive pathways in both the peripheral and     central nervous system. The origin of most acute pain from surgical stimulation is the     mechanical trauma of the local tissue and the subsequent acute inflammatory response.      No studies have investigated the combined use of anti-inflammatory analgesics with spinal     anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients     undergoing day-case IHR. The aim of the investigators study is therefore to assess the     efficacy of preoperative combined administration of etoricoxib and standard spinal     anaesthesia in the reduction of postoperative pain following IHR.   "
30616|NCT02884973|"     It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of     live births, 5,000 new cases per year currently in France These are serious diseases that can     be life-threatening to more or less short term.      The advances in surgical techniques in recent years has improved the prognosis of these     patients in the first months of life.      The success of surgery is, among other things, conditioned by a support per complex     operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic     support techniques.      These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of     non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.      The fundamental principle of NIRS based on an estimate of the percentage proportion of     cerebral oxy-hemoglobin.      A light source is emitted by NIRS and through body tissues to the brain where the light will     be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.      Refracted light will be analyzed by NIRS which in turn using software will help to determine     a percentage of oxyhemoglobin.      Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this     principle to estimate cerebral tissue oxygenation but also for other tissues such as the     kidney.      More than the figure, those are changes NIRS compared to a baseline that will alert us to the     conditions of tissue oxygenation and allow us to identify hypoxia times.      Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage     of oxyhemoglobin and deoxyhemoglobin percentage.   "
30617|NCT02884960|"     The purpose of this study is to evaluate the safety and effectiveness of Embozene     Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine     fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6     sites. Symptom severity, health-related quality of life, and the appearance of the fibroids     will be assessed prior to treatment. Patients will then undergo the uterine fibroid     embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which     will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and     12 months after the procedure, and imaging outcomes will be obtained 3 months after the     procedure.   "
30618|NCT02884947|"     This aim of this study is to improve the outcomes for patient with gliomas undergoing     neurosurgery by maximising the extent of resection whilst minimising neurological morbidity.     This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages     of the patients' clinical management.   "
30620|NCT02884921|"     Dental treatment for children should be done in a calm atmosphere and without pain. Oral     Propacetamol has been shown to be effective in a variety of postsurgical pain models.      There are no studies on paracetamol preemptive analgesia effect on the pediatric population     in the dental setting which compare analgesic effect when administered before Vs after the     dental treatment.      The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the     prevention of postoperative pain in children undergoing dental treatment.   "
30621|NCT02884908|"     The primary study objective is to determine the efficacy of pregabalin administered orally     for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress     disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor     genes. The secondary objective is to assess the safety and tolerability of pregabalin in     participants with alcohol use disorder and co-occurring posttraumatic stress disorder who     have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The     investigators will utilize a large and diverse sample of African-Americans that includes both     genders and individuals with different types of trauma. All participants will receive     standardized bi-weekly Brief Behavioral Compliance Enhancement Treatment (BBCET).   "
30622|NCT02884895|"     Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal     intubation is usually achieved by a direct laryngoscope.It is an effective method but     requires experience and skill demanding a long learning time.The use of the Laryngeal Tube     Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube     Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the     effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by     unskilled practitioners in anesthetized patients with the head in neutral position (trauma     model).   "
30623|NCT02884882|"     Compare the emotional experience of patients with focal lesions of the basal ganglia by     ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted     by neuropsychological and electrophysiological assessments.   "
30901|NCT02881268|"     Open-label, non-randomized, prospective, single center, observational, translational study   "
34036|NCT02840266|"     The purpose of study is to determine the diagnostic value of Hearing test program on smart     phone for detected patients who has hearing loss.   "
30624|NCT02884869|"     Control the airways by endotracheal intubation is an important part of treatment for a trauma     casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for     many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal     Mask Airway to achieve a definitive airway by unskilled practitioners.      The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will     be more success and faster compared to the standard way of direct laryngoscope.   "
30625|NCT02884856|"     Visual shade matching (VSM) is the most common procedure to select an adequate shade in     dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical     (VC) the most popular among the available guides. VSM is a subjective and inconsistent     process with many observer related variables (e.g. color deficiency, experience, gender and     eye fatigue) that can influence on the final color appearance. The gender influence on the     accuracy of VSM is controversial.      The purpose of this study is to evaluate the VSM performed by female (F) and male (M)     students, using VC shade guide, testing the null hypothesis that VSM is not influenced by     gender.   "
30626|NCT02884843|"     The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in     blind and fibreoptic endotracheal intubation.      The current randomized study is designed to assess the success rate of blind and fibreoptic     endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and     Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the     Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite     differences in their structural design.   "
30627|NCT02884830|"     Static hyperinflation is frequent in Chronic obstructive pulmonary disease (COPD) , resulting     in increased end expiratory lung volume and positive end expiratory pressure (PEEPi) at the     end of a normal expiration.      Static hyperinflation worsens the work of breathing is increases patient's dyspnea.      The application of a continuous positive airway pressure (CPAP) has been shown to improve     static hyperinflation and to decrease the work of breathing.      Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation.     The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and     functional respiratory parameters.   "
30628|NCT02884817|"     A commercially available mouth rinse with ethyl lauroyl arginate and essential oils claims to     have enhanced antimicrobial properties as compared to the traditional essential oil products.     The aim of the present study was to compare the plaque and gingivitis inhibiting effect of     the commercial product containing essential oils with ethyl lauroyl arginate with one placebo     and one negative control in a modified experimental gingivitis model. In three groups of     healthy volunteers, experimental gingivitis was induced and monitored over 21 days,     simultaneously treated with the commercial test solution, 21.6% hydro-alcohol solution and     sterile water respectively. The maxillary right quadrant of each individual received     mouthwash only, whereas the maxillary left quadrant was subject to both rinsing and     mechanical oral hygiene. Compliance and side effects were monitored at day 7, 14, and 21.     Plaque and gingivitis scores were obtained at baseline and at day 21.   "
30629|NCT02884804|"     At the entry of the delivery room, a standard blood analysis will be performed (Blood count,     PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the     center's practices.      The percentage of the immature platelets is a an additional parameter on the hemogram.      The clinical assessments (recorded in medical records) and biological values will be used to     determine if there is a correlation between these data and the occurrence of postpartum     hemorrhage.   "
30630|NCT02884791|"     The primary aim of this study is to examine the effect of acute ingestion of fructose on     serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with     metabolic syndrome.   "
30666|NCT02884323|"     This is a single centre open label study measuring lower limb physiology in patients with     venous leg ulcers at the University Hospital of South Manchester.      Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in     microcirculation will be measured at baseline after the gekoTM device is activated.     Ambulatory venous pressure and venous transit times will be performed whilst the participant     is standing, sitting and supine   "
30631|NCT02884778|"     Title: Evaluation of the last version of the PMD200TM and its NoL index in patients     undergoing laparotomies with intraoperative epidural analgesia Objectives: Measure NoL Index     variability after a nociceptive stimulus at various intravenous remifentanil infusion rates.     To compare the results obtained with the PMD200TM with those gathered in our previous study     with the PMD100TM under the same clinical conditions.      Study Design: Prospective observational study Subject Population: Adults scheduled to undergo     elective abdominal surgery with laparotomy under general anesthesia and epidural analgesia     Sample Size: 30 patients Study Duration: Starts April 2016 - Ends September 2016 Study     Center: Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None expected   "
30632|NCT02884765|"     Prospective data will be collected in approximately 250 patients sustaining BCFx with or     without any additional fracture(s) of the symphysis. Patients will be followed according to     the standard (routine) at approximately 6 weeks and 3 months after the treatment. Data     collection will include fracture details (i.e. classification, mechanism of injury),     treatment details, functional and patient-reported outcomes, and anticipated or     procedure-related adverse events (i.e. complications).   "
30633|NCT02884752|"     Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide     between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University     hospitals in France. This increasing number of cases raises several issues. Are they the     consequences of better detections and reporting, or are they reflecting any epidemiologic     changes? For answering these questions, we performed a 10 year (2002-2012) retrospective     multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter     species.   "
30667|NCT02884310|"     Individually-tailored administration of the opioid analgesic component during general     anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to     look if the gradient response of a nociception index to a calibrated tetanic stimulus during     standard anesthetic conditions, could help to titrate remifentanil analgesia before tracheal     intubation and before skin incision. The studied parameters are the SPI index developed by     General Electric, the Analgesia Nociception Index and the pupil dilation using the pupil     scan algometer.   "
30634|NCT02884739|"     As in the general population, there is a gradual and steady increase in life expectancy of     patients with schizophrenia. But this increase is at a smaller scale, with a rate of     premature death that is still 2 to 3 times higher than that found in the general population.     This excessive early mortality is explained by an overrepresentation of suicide deaths, but     also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are only     very few epidemiological data on the mortality of patients with schizophrenia, including     those aged over 60 years. What are the sociodemographic and clinical characteristics     (psychiatric and somatic) of these schizophrenic elderly patients? Do they benefit from a     somatic follow-up adequate and systematic? What are their levels of social independence and     of quality of life? the answers these questions and the description of the offer of geriatric     care and of psychiatric care currently provided by different sectors of psychiatry in France     is an indispensable prerequisite for any project to improve the quality of life, state of     health and mortality of older patients with schizophrenia.   "
30635|NCT02884726|"     The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in     subjects with advanced and/or metastatic solid tumors.   "
30636|NCT02884713|"     Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy.     Different second-line therapeutic options are available. However, the success of second-line     therapy has not been addressed or reported from Saudi Arabia.      Objectives The primary objective was to evaluate the efficacy of the 10-day course of     levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H.     pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to     treatment, factors associated with eradication of H. pylori and adverse events associated     with the treatment.   "
30637|NCT02884700|"     The study aimed at further describing the epidemiological, clinical, diagnostic and     prognostic features in legionellosis cases admitted to Grenoble University Hospital during     the 2006-2011period. The investigators also tested lower respiratory samples collected from     these patients during their routine medical care, using a number of molecular tools allowing     determination of the involved Legionella species, the bacterial load, and the presence of     antibiotic resistant mutants. Our primary goal was to define biological markers that could     predict severity and outcome of infection in legionellosis cases requiring hospitalization.   "
30638|NCT02884687|"     The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville     (CHRMT) between 2007 and 2014. To analyze the strategies and decisions related to the     appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are     realized on the study period with all concerned actors of the Good Use of antibiotics. An     interviewing plan and tree interview guidelines were created. All SDI are processed by the     same person.   "
30639|NCT02884674|"     Evaluate the therapeutic effect of a functional Magnetic Resonance Imaging (fMRI)-guided and     robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right     inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind,     randomized, placebo-controlled, monocentric study.   "
30640|NCT02884661|"     In order to evaluate the implementation for the recommendations about the patient care for     atrial fibrillation in aged patients, a non-interventional study is performed retrospectively     by comparing two approach of the focus in Cardiology Department and in Geriatric unit.   "
30641|NCT02884648|"     The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to     control ovarian, fallopian, or primary peritoneal cancer that has been found during     second-look surgery.   "
30642|NCT02884635|"     The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics     and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.   "
30643|NCT02884622|"     Lung disease progression is variable among cystic fibrosis (CF) patients and depends on DNA     mutations in the CFTR gene, polymorphic variations in disease-modifier genes and     environmental exposure. The contribution of genetic factors has been extensively     investigated, whereas the mechanism whereby environmental factors modulate the lung disease     is unknown. Because these factors can affect the epigenome, investigators hypothesized that     DNA methylation variations at disease-modifier genes modulate the lung function in CF     patients.   "
30644|NCT02884609|"     The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous     administration of Paracetamol for patients in palliative care.   "
30645|NCT02884596|"     To evaluate the success of inferior alveolar nerve block (IANB) for mandibular molars with     irreversible pulpitis in women under treatment with selective serotonin reuptake inhibitors     (SSRIs).   "
30646|NCT02884583|"     Prevalences of food allergies and asthma increased in the population during the last decades.     These two pathologies, responsible for a real burden, are often associated and are to be     considered as comorbidities; this aspect is more and more studied in the literature and many     authors tried to find a link between diets and asthma. The narrow link between these two     atopic pathologies and the fact that food allergy can come along with respiratory symptoms     also in patients without history of asthma must be better understood, considered into the     management of food allergy. The main objective of this study is to study the prevalence of     signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge     (OFC) in patients older than 5 years. The secondary objective is to study the risk factors to     develop asthma during a food allergy reaction.      This historical-prospective single center study , was realized in the Allergy Unit of the     University Hospital of Montpellier. All the patients having been hospitalized for a positive     OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was     established according to the recommended international clinical and physiological criteria.     Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was     calculated. The search for risk factors was made by a logistic regression univariate then     multivariate, completed by a decision tree.   "
30647|NCT02884570|"     To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and     fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.   "
30668|NCT02884297|"     The purpose of this study is to evaluate the feasibility of the measurement of the placental     perfusion during the first trimester of pregnancy by 3D Doppler ultrasound angiography with a     contrast agent: SonoVue®.   "
30648|NCT02884557|"     Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC).     These diseases are a public health problem because they concern many patients (1 case in     1000). IBDs are characterized by dysregulated immune response against luminal antigens     causing chronic inflammation of the gut in genetically predisposed individuals. Their exact     cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is     a liver inflammatory disease of unknown origin that is known to be strongly associated with     IBD. An important clinical observation highlights the mild symptoms of IBD when associated to     the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is     associated with a progression of intestinal inflammation.      Based, on these clinical findings that suggest a protective effect regulator of liver     inflammation on intestinal inflammation, and on the results obtained by our group in mouse     models that identified the natural killer T cell (NKT) as essential in control of     experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell     markers are increased in the colon of patients with PSC+IBD compared to patients with IBD     alone or PSC alone.   "
30649|NCT02884544|"     The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady     state (following up to 5 weeks of treatment) in children using an outpatient, single-center,     open-label, flexible dose-escalation study design.   "
30650|NCT02884531|"     The incidence of hip osteoarthritis (OA) is rising in western countries due to an ageing     population and the epidemic of obesity. Patients with hip OA tend to complain of hip pain and     stiffness which affect alignment and mobility of the whole body and typically result in     general musculoskeletal pain and disability. Clinical guidelines recommend a combination of     exercise therapy, weight loss and education, adjusted to the individuals needs, to be tried     out before arthroplasty eventually is offered. However, to obtain a satisfactory long-term     outcome is a challenge as patients may not be motivated to comply with a training program     including functional strength and mobility training, if not guided by a therapist. Basic Body     Awareness Therapy (BBAT) may be an alternative training modality with a better potential for     lasting effects. It is a low-impact movement therapy focusing on alignment of the body and     quality of movements, implemented in daily life activities. In the BBAT learning process by     doing, reflecting on and transferring body awareness into daily life movements, the     investigators hypothesize that the patients will obtain self-efficacy and mastering, of     importance for continued training on their own. This hypothesis will be examined in the     present randomized controlled trial, comparing Patient Education combined with BBAT and     Patient Education alone. The investigators will, accordingly, examine the supplementary     effects of BBAT for patients with hip OA. They will also explore the importance of movement     quality as observed by physiotherapist using Body Awareness Rating Scale, and how it relates     to how patients perceive their movement performance. In the study the investigators will     particularly address long-term effects of the intervention by comparing survival of the     native hip in the two groups included in the study. Data from the study will be included in a     national database of patients with non-surgical treatment of hip and knee OA (NOAR), giving     rise to comparison of different movement therapies.   "
30651|NCT02884518|"     The purpose of this study is to determine whether dopamine synthesis capacity by using [18     fluorine(F)]-DOPA PET for patients with schizophrenia in the maintenance phase can predict     treatment discontinuation.   "
30652|NCT02884505|"     The overall purpose of this study is to employ a pragmatic, multidimensional assessment of     hypersomnolence that piggybacks on routine clinical care in patients with suspected     disorders of central nervous system (CNS) hypersomnia, to determine whether these additional     objective and subjective assessments are useful in the diagnosis and management of these     patients.   "
30653|NCT02884492|"     This study is being done to learn about tau tangles in Alzheimer's disease. A type of PET     scan is used to measure the abnormal accumulation of protein called tau in the brain. These     are thought to be involved in Alzheimer's disease. The investigators will also perform brain     MRI and to tests to measure the participant's memory and thinking.   "
30654|NCT02884479|"     The purpose of this study is to test PT-112 in Combination with Docetaxel in Subjects with     Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects with Non-Small Cell     Lung Cancer.   "
30655|NCT02884466|"     Introduction Chronic low back pain (CLBP) is a highly prevalent health condition, and the     leading cause of years lived with disability. The high prevalence causes a substantial impact     on patients, communities and health-care systems. There is a continuing challenge to offer     evidence-based rehabilitation for patients with CLBP. There is a lack of studies on adequate     follow-up approaches to maintain successful treatment. No earlier study has assessed if the     positive treatment effects of a multidisciplinary rehabilitation intervention can be     maintained with an intervention alternating between inpatient interventions and home-based     activities.      Aim To assess if a novel multidisciplinary rehabilitation intervention is more effective in     maintaining successful treatment after 6 months, than a usual multidisciplinary     rehabilitation intervention in patients with CLBP.      The novel intervention is a 14-week program alternating between in total three weeks of     inpatient intervention and home-based activities. This alternation allows the participants     time and opportunity to adapt and transfer inpatient learning to activities and participation     in their own environment in interaction with everyday life situations and surroundings. Usual     care is a four-week inpatient intervention. It is hypothesized that the intervention will be     superior to usual care.      Method The study will be conducted at The Danish Rheumatism Associations' rehabilitation     centre Sano Aarhus. 160 participants with CLBP will be randomly allocated to one of two     groups. The novel intervention consists of: 1) a pre-admission day, 2) two weeks of     home-based activities, 3) two-week inpatient period, 4) four weeks of home-based activities,     5) 1st two-days inpatient follow-up, 6) six weeks of home-based activities and 7) 2nd     two-days inpatient follow-up. Usual care consists of a four-week inpatient intervention.      The two groups will be compared according to disability, pain, pain self-efficacy, quality of     life, depression and exercise capacity.      Relevance The present study has emerged out of the fields where patients, clinicians and     researchers intersect and is consequently highly clinically relevant. If positive treatment     effects can be maintained or even improved in the long term, the results may serve as     inspiration for the design of multidisciplinary rehabilitation interventions in clinical     practice; this will be valuable for future patients with CLBP.   "
30669|NCT02884284|"     In order to accelerate border crossing between basic research and clinical research in breast     cancer, it is necessary to easily use clinical and biological data. That is the reason why it     is very important to create a clinical, biological and pathologic beast cancer database,     mainly prospective but also retrospective. All data are from patients treated in Toulouse     Centre.      The scientific community will easily have access to clinical and biological informations     through a centralized, structured database , leading to optimize patients with breast cancer     treatment.   "
30670|NCT02884271|"     In the last ten years patient safety during routine surgical interventions has increased;     however as there is an increase in the number of specialized surgical interventions and high     risk patients like elderly and emergency patients, the incidence of perioperative cardiac     arrest has not reduced but remains fixed. The incidence of perioperative cardiac arrest     varies from 4.3-34.6 for each 10,000 procedures. However as in a lot of other countries exact     data are lacking also for Turkey. With this study the investigators want to start collecting     data about intraoperative cardiac arrest in Turkey, starting at their institution The aim is     to evaluate the incidence and outcome in the study. Secondary aim is to assess the causes of     cardiac arrest in the operating room.   "
30671|NCT02884258|"     This case-control study compares IVF results and live birth rates in women undergoing IVF     with a history of bariatric surgery as compared to women without bariatric surgery history     and matched for weight, age and parity.   "
30656|NCT02884453|"     Some cancers of the oesophagus and stomach express excessive copies of either the cMYC     (Myelocytomatosis oncogene) gene, the HER2 (Human epidermal growth factor receptor 2) gene or     both. These genes may potentially contribute to the growth and spread of cancer.Ibrutinib is     a drug that is already used in the treatment of certain cancers of the immune system.      There is preclinical evidence that it shows activity against gastric and stomach cancer cells     over-expressing cMYC and HER2 genes.      The iMYC study will assess the activity of ibrutinib in cancers of the oesophagus and stomach     which over-express these genes and which have previously been treated with standard     chemotherapies.      Any anti-cancer activity seen will be measured and correlated with metabolic changes on FDG     (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) - PET (positron emission tomography)     scan, changes in DNA and circulating tumour cells in the blood, and molecular changes in the     cancer itself through the use of optional repeat tumour biopsies. If an effect is seen it     could provide justification for further research in this group of patients.      Patients will be eligible if they have advanced cancer of the oesophagus or stomach and have     been treated with at least one line of prior therapy. The study will be conducted at the     Royal Marsden Hospital at its Sutton and Chelsea sites.      It will involve an initial group of up to 17 patients. Screening, recruitment and follow up     will last for 3 years in total.      Patients wishing to take part must consent to having their cancer biopsied to test for cMYC     and HER2 amplification, as well as a number of imaging and blood tests. There are optional     further tumour biopsies whilst on study.      Patients will be treated with ibrutinib until progression of their disease or unacceptable     toxicity.   "
30657|NCT02884440|"     Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to     treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after     spine surgery with 24 hours morphine consumption   "
30658|NCT02884427|"     The design aims to investigate the value of direct current, specifically the polar effects     this has, and its influence on neuromuscular changes described in the literature. This     research proposal seeks to assess the influence of application anode and cathode pole in     muscle strength when testing handgrip dynamometry by healthy subjects. The study will     evaluate changes in muscle strength when performing a manual dynamometer test in a group     exposed to the application of cathode, another exposed to the application of anode, compared     with a control that will not receive the intervention will be evaluated. Subsequently the     investigators proceed to compare the maximum force obtained from the dynamometry test in each     of groups and between the groups .   "
30659|NCT02884414|"     The purpose of this study is to quantify differences in joint mechanics between different     types of walking in healthy individuals and individuals with knee pathology. The     investigators will determine how modifying gait through feedback and/or cutaneous stimulation     changes joint loading.   "
30660|NCT02884401|"     This is a prospective case series study aiming to evaluate the effect of post-menopausal     osteoporosis on the jaw bone around dental implants with a modified titanium surface. The     study consists of 8 visits that will be performed within a minimum period of 15 months.     Participants will be recruited from the Rheumatology Department and Radiology Department at     Barts Health National Health Service (NHS) Trust.      Participants will include 20 post-menopausal osteoporotic women with a requirement of a tooth     to be replaced. The main objective of this study is to radiographically compare alveolar     (jaw) bone changes in width and height after the placement of a dental implant with a     hydrophilic (SLActive) surface and 12 months after loading (placement of the crown) it in     post-menopausal osteoporotic women.   "
30661|NCT02884388|"     The purpose of this study is to validate the hypothesis that a combined nerve block produces     better outcomes including intraoperative stress, hemorrheological indexes, postoperative     immune function, and incidence of postoperative complications than general anesthesia.   "
30662|NCT02884375|"     The management of older patients with cancer has become a major public health concern in     Western countries because of the aging of the population and steady increase in cancer     incidence with advancing age. Cancer treatment of aged patients is complex due to     comorbidities, polypharmacy and functional status. The heterogeneity of the older population     in terms of comorbidities and functional status may explain the difficulty in establishing     management recommendations.      Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can     evaluate patient's resource and strengths, in order to help oncologist to define the most     effective treatment. The GA developed by geriatricians and recommended by the International     Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health     status; comorbidities; functional status; nutritional, cognitive, psychological, and social     parameters; and medications. The GA uses validated geriatric scales to produce an inventory     of problems, which can then serve to develop an individualized geriatric intervention plan;     it may be an important step in selecting elderly patients for cancer screening and treatment.      The objectives are:        -  To assess the role of GA for decision making process for older patients with cancer        -  To identify geriatric and oncologic factors associated with overall survival, treatment          feasibility, toxicities, morbidities        -  To develop and/or validate screening tests for frailty in geriatric oncology        -  To develop and validate frailty classifications      Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study     that includes all patients age 70 years or older who has a diagnosis of solid cancer or     hematologic malignancies in French hospitals   "
30663|NCT02884362|"     In research on melanoma, translational research is the essential link between basic research     and clinical research by facilitating the passage between discovery and improvement in the     quality of patients care.That is the reason why it is very important to collect, and     centralize clinical and biological data of patients with melanoma.      The aim of the project is to provide to scientific community a structured, mixed clinical and     biological database, unique in France, in order to insure accessibility to clinical data.   "
30664|NCT02884349|"     The aim of the study is to determine the influence of the combined anteversion of acetabular     cup and the femoral stem used in total hip arthroplasty on the theoretical and actual range     of motion of the hip in three dimensional space.   "
30665|NCT02884336|"     Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused     by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being     the orange zest and the bacteria is considered harmless.   "
30672|NCT02884245|"     E2 given in late luteal phase can be extended beyond the onset of menses for a period of at     least eight days before the start of the stimulation, allowing scheduling of stimulation in     order to limit oocytes retrievals during weekends .      Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended     release kinetics, seems particularly interesting for a synchronous recruitment of follicles     after homogenization of the cohort.      The objective of this study is to evaluate the impact on the response to ovarian stimulation     with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age     at which declining of ovarian reserve usually begins. The management of these patients in     terms of organization of the center is also evaluated.      The scheduling of IVF cycles represents a double benefit. On one hand, to enable a     synchronization of the follicular cohort for a best response and a higher number of mature     oocytes. On the other hand, a more efficient organization for both the center (avoiding     retrievals on weekends and public holidays, organize and distribute equally the activity,     reduce cost operations) and couples (personal and professional organization).   "
30673|NCT02884232|"     The purpose is to evaluate feasibility of medical supervision of professionally active     asymptomatic wood workers with questionnaires and nasofibroscopy.      Secondary purposes are:        -  Feasibility evaluation of identification of former and actual professional expositions          to wood dust and to various naso-sinusal carcinogenics in case of co-expositions          (formaldehyde, chrome, nickel, leather)        -  Description of abnormal symptoms identified by occupational doctor and needing an          otorhinolaryngology test        -  Description of results and examinations induced by nasofibroscopy in symptomatic or          asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases        -  Evaluation of participation of workers retiring in 2 years after inclusion to medical          supervision program        -  Evaluation of information flow among different players        -  Assessment of costs induced by this targeted screening: direct medical costs (screened          pathologies, induced additional examinations…) and indirect costs for company (duration          of worker absence for transfer, medical and additional examinations).   "
30674|NCT02884219|"     Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in     preterm infants, especially in those born at a gestational age <28 weeks and/or a birth     weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has     been associated with serious complications. However, a common finding is that medical and/or     surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity.     This might be related to the fact that a substantial portion of preterm infants are treated     unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any     specific intervention. An expectative approach is gaining interest, although convincing     evidence is still missing.      The objective of this study is to investigate whether in preterm infants <28 weeks' gestation     with a PDA an expectative management is not inferior to early treatment with regard to the     composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary     dysplasia (BPD) at a postmenstrual age of 36 weeks.   "
30675|NCT02884206|"     The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on     cognitive function in patients with heart failure with preserved ejection fraction. Cognitive     function will be assessed using a comprehensive battery of tests with an evaluation of     longitudinal change of cognitive domains including memory, executive function, and attention.   "
30705|NCT02883816|"     The main objective of this study is to show that there is a concordance between lung disease     at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis     asymptomatically.      This will identify at the first examination at 8 weeks, newborns who have the most impaired     lung function at 13 months. To meet this objective an assessment of their lung function at 9     weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.   "
31022|NCT02879682|"     To compare presurgical motor mapping by navigated transcranial magnetic stimulation for     surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data     into neuronavigation as control.      Primary objective: Permanently new postoperative deficit is lower when the preoperative motor     mapping is available to the surgeon   "
30676|NCT02884193|"     Cryotherapy has a wide range of clinical applications in rehabilitation, used for activities     such as controlling inflammation, pain control or management of edema after an injury or     surgery. In the field of cryotherapy they studied cold neuromuscular responses, where it has     shown a decrease in nerve conduction velocity, which leads to a decrease in muscle strength.     However it has been described in some work applications brief cold (Quick Icing) may be     opposite to those described effects, increasing the strength, the time of intervention the     most important and decisive in these possible improvements or decreases factor. This effect     is observed in response to a few seconds of application of cold, and would be given by an     increased activity of motor neurons. Assess the influence of rapid cooling application     (Technique Quick Icing) and prolonged cooling in handgrip strength when performing a manual     dynamometer test in college students.   "
30677|NCT02884180|"     Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group     clinical trial      Trial acronym: DEXRAR      Background: Effective postoperative pain management is essential for the well-being and     rehabilitation of the surgical patient. No gold standard exists for pain treatment after     revision total knee arthroplasty (TKA) and combinations of different medications are used     with virtually no evidence for combined analgesic efficacy.      Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone     as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local     infiltration analgesia      Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B)     isotonic saline i.v.      Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised     computer-generated allocation sequence and allocation concealment with block size of 12.     Blinding of assessor, investigator, caregivers and patients.      Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for     the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of     0,05 and a type 2 error rate of 0,20.   "
30902|NCT02881255|"     The purpose of the study is to compare standard, single chamber transvenous ICD to     sub-cutaneous ICD in occurrence of perioperative and long term device related complications     and failed appropriate clinical shocks and arrhythmic death.   "
30678|NCT02884167|"     Constipation is a symptom based disorder with a prevalence of 15% in the adult population and     its management remains challenging. Although not life threatening, constipation is associated     with impaired quality of life, increased healthcare costs and excess work absenteeism.     Constipation represents a heterogeneous disorder with a multifactorial pathogenesis. Several     risk factors have been suggested to lead to the condition and are divided in 3 main     categories: a) physiological, b) environmental and c) demographic. To date, there is lack of     large epidemiological studies on proposed aetiological factors of constipation, especially     studies assessing all proposed risk factors of constipation together.      The overall aim of this study is to investigate the multidimensional (physiological,     environmental and demographic) predictors of constipation with the use of a multivariate     analysis statistical model.      This is a large single centre case control study comparing constipated adults with healthy     individuals matched for age, gender and ethnicity.      The duration of the study is 2 weeks in total and includes a screening visit, a 2 week run-in     period and a baseline visit at the end of the run-in period. Transit time between constipated     and healthy individuals is assessed at baseline visit. Differences in gastrointestinal     symptoms, dietary intake as well as differences in stool output (e.g. stool frequency and     consistency) between constipated and healthy individuals are assessed over the baseline     period (the week before the baseline visit). Differences in female sex hormone levels as well     as stool markers and markers of fermentation (e.g. fecal water, stool pH, short chain fatty     acids) between constipated and healthy individuals are assessed at baseline visit.     Furthermore, differences in environmental measures (physical activity, anxiety, smoking) and     differences in demographic measures (age, gender, body mass index) between patients suffering     from constipation and healthy individuals are also assessed at baseline visit.   "
30679|NCT02884154|"     The exact incidence of subepithelial tumors (SETs) in the gastrointestinal (GI) tract is     unknown, but the prevalence of gastric SETs detected during routine     esophagogastroduodenoscopy is 0.36%. GI SETs may include leiomyoma, GI stromal tumor (GIST),     schwannoma, lipoma, cyst, or ectopic pancreas. Surgical resection is the principal diagnostic     and therapeutic method for SETs, especially for large and symptomatic ones. Preoperative     pathological diagnosis of SETs may facilitate clinical decision making, but conventional     endoscopic forceps biopsy does not yield adequate amounts of subepithelial tissue for     definitive diagnosis.      Although endoscopic ultrasonography (EUS) is the best imaging modality for the evaluation of     SETs, it cannot substitute histopathological diagnosis. EUS-guided fine-needle aspiration     (EUS-FNA) may provide adequate amounts of tissue for the diagnosis of SETs, but it does not     always afford adequate samples for immunohistochemical analysis because of the often small     number of cells obtained by aspiration. Since some SETs, especially GI mesenchymal tumors     such as GIST or schwannoma, have varied morphologic appearances, and diagnosis using a small     biopsy is not straightforward, immunohistochemical analysis is strongly advisable, if not     essential. EUS-guided Trucut biopsy (EUS-TNB) may overcome the limitations of EUS-FNA in     procuring sufficient core tissue specimens. Although EUS-TNB is more accurate than EUS-FNA     for diagnosing GI mesenchymal tumors, the rigidity of its 19-gauge (G) caliber and the     mechanical friction of the firing mechanism produced by the torqued echoendoscope limit its     use for SETs located in the gastric antrum and duodenum. Therefore, a needle facilitating     adequate histological core sampling with easy maneuverability needs to be established. A 19G     EUS-guided fine-needle biopsy (EUS-FNB) device with ProCore reverse-bevel technology was     recently introduced. A multicenter study revealed that histological samples could be     successfully obtained using this needle in most patients having GI SETs, with a diagnostic     accuracy of >80%.10 However, because of technical difficulties with this needle in the     gastric antrum and duodenum, the same FNB device was recently developed in a 20 G platform     with coiled sheath. This prospective, multicenter study aimed to evaluate feasibility, yield,     and diagnostic accuracy of a newly developed 20 G ProCore needle with coiled sheath in     patients with GI SETs.   "
30680|NCT02884141|"     ARCADIA is a national registry designed to document phenotypic and genetic traits in patients     with renal and/or cervical artery fibromuscular dysplasia (FMD).      FMD is a group of arterial diseases that most commonly involve renal and carotid arteries.     Patients with FMD may present with renovascular hypertension and/or with cerebrovascular     symptoms. Angiographic classification includes the multifocal type and the focal type. FMD     may affect one or more vascular beds and progress to more severe stenosis and to renal or     cerebrovascular complications. FMD may be familial (OMIM #135580).      Our main objective is to create a FMD registry that will collect standardized information     from all consenting patients diagnosed with the condition in 16 participating centers. This     registry, along with a collection of leukocyte DNA, will constitute a resource for further     clinical research on FMD. The first application will be the assessment of the frequency of     multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal     artery FMD and vice-versa. The second application will be a case-control study to identify     susceptibility genes for FMD.      Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with     either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial     angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection     of bioclinical and morphologic information. Phenotypic assessment will be performed in     accordance with current recommendations and best clinical practice.      Given the multicenter nature of the study and the recruitment capacity of each centre,     enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate     estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95%     confidence interval will extend 0.035 from the observed proportion for an expected proportion     of 0.20 based on a previous report and from our unpublished data. 2) In addition to a     collection of 400 renal FMD already collected at HEGP, give sufficient power for a     genome-wide association study seeking for susceptibility genes   "
30681|NCT02884128|"     This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal     encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid     tumors.   "
30706|NCT02883803|"     The purpose is to determine the effect of mesenchymal stem cells administered at the early     phase of septic shock on the evolution of organ failure assessed by SOFA score (Sepsis Organ     Failure Assessment score) on day 7 (or death day or day of recovery unit exit if before day     7) compared to that observed in a group of control patients.      The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the     occurrence and duration of failure of each organ and on the mortality at day 28 and day 90.     The safety of administration will be also assessed.   "
30682|NCT02884115|"     A continuing challenge to determining the response to treatment of early syphilis (primary,     secondary, early latent syphilis) is exemplified by the substantial proportion of patients     who fail to achieve serological cure and remain serofast. Although retreatment is often done     in clinical practice, optimal management remains uncertain due to the paucity of data     regarding serological response to retreatment and long-term outcomes. Furthermore, the     investigators cannot rule out that the gradually increasing seroreversion/serological cure     rates may have been due to the natural decline in rapid plasma regain (RPR) titers after     initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the     investigators would like to conduct a clinical trial to compare the serological response     rates of serofast early syphilis cases retreated with three doses benzathine penicillin and     absence of any retreatment (control group).   "
30683|NCT02884102|"     Here we propose an integrative sequencing approach utilizing a 1500 gene exome comparative     analysis between multiple myeloma or related plasma cell malignancies and normal cells     coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of     the genetic alterations for the purpose of identifying informative and/or actionable     mutations in patients with multiple myeloma and plasma cell malignancies. The approach will     enable the detection of point mutations, insertions/deletions, gene fusions and     rearrangements, amplifications/deletions, and outlier expressed genes among other classes of     alterations.   "
30720|NCT02883621|"     Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip     of the colonoscope, was proven to increase the adenoma detection rate during screening     colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization     and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is     still under investigations. The aim of this study is to compare the diagnostic yield of the     CAE to the standard endoscopy in esophagus.   "
30684|NCT02884089|"     This study will look at how a single dose of abemaciclib will impact the body's ability to     get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the     effect of a single dose of abemaciclib on kidney function by measuring blood and urine     markers. Side effects will also be documented.      Each participant will complete four study periods. During each study period, participants     will stay in the clinical research unit for nine days and eight nights.      The study will last approximately 10 weeks, not including screening. Screening is required     within 28 days prior to the start of the study.      This study is for research purposes only and is not intended to treat any medical condition.   "
30685|NCT02884076|"     To validate the ability of the Sodergren score in guiding the management of symptomatic     haemorrhoids in a Malaysian population.   "
30686|NCT02884063|"     In the way for developing and optimizing protocol to be used as non- invasive methodology     used as routine testing for PGS.      This protocol is to be adapted to replace the using of life embryo cells for genetic testing     and aneuploidy study as well as for any type of genetic testing including single gene     disorder or HLA typing or study.   "
30687|NCT02884050|"     Data generated from this pilot project will be used to support a larger, NIH funded study to     investigate the physiologic mechanisms associated with the cognitive side effects of a     commonly prescribed antiepileptic drug (AED), topiramate (TPM). This study will provide pilot     data to 1) demonstrate the viability of using quantitative electroencephalogram (EEG) to     examining physiological effects of AEDs as they relate to language function, and 2) perform     formal power estimate calculations in support of a longer-term connectivity study using     stochastic modeling techniques including power, coherence, and Granger causality metrics to     analyze AED effects on quantitative EEG. Traditionally, the cognitive side effects of AEDs     have been considered a byproduct of decreased neuronal excitation associated with medical     therapy, although recent data suggests that this may not be true for some newer medications,     such as TPM. The proposed experiments will employ quantitative EEG to investigate the effects     of topiramate on neuronal network connectivity and pharmacokinetic/pharmacogenetic     relationships in order to explore individual physiological responses. Topiramate is selected     because of its relatively unique effects on generative verbal fluency, but unlike older AEDs,     TPM is associated with little EEG change. The investigators will compare the effects of TPM     to baseline and an inactive placebo in a randomized double blind crossover design.   "
30688|NCT02884037|"     In this multicentric, double-blind, randomized,placebo-controlled study, the investigators     hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial     overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine     production. This work evaluates the efficacy of 6 months administration of rifaximin in NAFLD     patients.   "
30689|NCT02884024|"     An observational study designed to compare colonic cytokine concentrations in lean versus     obese individuals   "
30690|NCT02884011|"     Retrospective study to examine the effects of chronic antihypertensive medications on     vasopressor dosing in septic shock   "
30691|NCT02883998|"     To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal     outpatient physical therapy (OPT) after hospital discharge of patients undergoing a     unicompartmental knee arthroplasty (UKA).   "
30692|NCT02883985|"     The purpose of this study is to determine whether high dose of radiation therapy (RT) are     effective over standard 6-week radiation treatment in patients with breast cancer   "
30693|NCT02883972|"     This study will investigate whether influenza vaccine uptake by school-age children (in     school-based clinics) can be increased by making behavioural-insight informed changes to the     invitation process which encourage parents to return consent forms.   "
30694|NCT02883959|"     Pain is a common problem encountered in about 60 % of critically ill patients who can     communicate. Its occurrence can be related to several causes, mainly dominated by invasive     procedures.      Pain management is typically based on a combination of prevention, evaluation, and     therapeutic agents. However, it appears important to develop adjuvant approaches. Music     therapy is one of them and that has been evaluated in various medical conditions.      The aim of our study is to evaluate the analgesic effect of music therapy in critically ill     patients during potentially painful nursing procedures.   "
30707|NCT02883790|"     The aim of this placebo-controlled randomized study is to evaluate the effects of Melatonin     1mg/Zn 30% VNR/Mg 100% VNR (food supplement) in the management on sleep quality and mood     alteration in cancer patients   "
30817|NCT02882360|"     Pregnant women with BMI>40 will be approached for participation in a study to reduce the rate     of post-operative wound infection from C-section. Women will be randomized to a commonly used     wound product (Kerlix-AMD) which consists of a PHMB-impregnated gauze versus normal gauze,     and rates of post-operative surgical site infection will be assessed. Women with a planned     procedure will also be randomized to applying Kerlix versus gauze for 3 days pre-operatively     to determine if this improves outcomes as well.   "
30695|NCT02883946|"     Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of     lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs,     cladribine and pentostatin, which have shown similar efficacy and constitute the gold     standard of care either as front-line therapy or for relapsed patients.      However, despite the remarkable response rates obtained with purine analogs therapy, some     patients will eventually relapse and the efficacy of these agents seems to decrease at each     line of treatment. The addition of new molecules to purine analogs may improve the response     rates and prevent relapse.      Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20     molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years     ago and several series of patients treated with rituximab as monotherapy were published in     the following decade, reporting response rates ranging from 25% to 80%.   "
30696|NCT02883933|"     The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in     western populations. Among all melanomas, those located on the head and neck are more     frequent than expected regarding the surface of this anatomical area, occur in older subjects     than melanomas at other sites and have a worse prognosis than melanomas at other sites. The     question whether head and neck melanomas could be a distinct entity has been debated.   "
30697|NCT02883920|"     Work related asthma and rhinitis are frequent diseases with a significant morbidity and a     social and economic impact. Farmers are highly exposed to various inhaled agents such as     organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders     and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis     and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop     farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to     pollen allergy, especially gramineae pollen. They can also be related to the use of     pesticides or exposure to mites .   "
30698|NCT02883907|"     The utility of conventional imaging in the development of new treatments for osteoarthritis     (OA) is hindered by:        1. Difficulty in non-invasively evaluating the initial response to potential new treatment          options. OA typically develops over a long time period, so evaluating the efficacy of          new treatment options over a timeframe relevant to experimental medicine studies is          difficult.        2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous          condition and identifying which subgroups of patients are most likely to benefit from          new treatments is crucial.      Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential     to solve these problems. However, their reliability needs to be fully established and     knowledge of likely effect sizes is required to inform sample size considerations for further     longitudinal/interventional studies.      This study aims to help address these issues by:        1. Calculating effect sizes for MR measurements to inform sample size calculations for          future studies.        2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee          joint.      The investigators will examine a single knee of an initial 15 participants with MR.     Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with     clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex     and body mass index in a 1:2 ratio) who do not have clinical features of OA.      Participants will undergo an initial (baseline) MR examination, followed by repeat MR     examinations at approximately 1 month and 1 year following the baseline examination.      This will allow us to assess both the reliability of our MR measurements and the expected     progression in our MR measurements in OA subjects in the absence of any disease-modifying     intervention.   "
30699|NCT02883894|"     Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin     in European countries, including France.      Immunologically, BP is characterized by the production of autoantibodies directed against two     major components of the hemidesmosome, BP180 and BP230.      The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its     serum level at diagnosis have been correlated with disease activity. The anti-BP230     autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis     did not correlate with disease activity.      Up to now, no clinical or immunologic factors have been identified to predict outcome of     patients with good or poor prognosis bullous pemphigoid as defined by long complete remission     off therapy and recurrent disease requiring maintenance therapy for years. The usefulness of     BP180 or BP230 ELISA scores for monitoring BP patients during treatment also remains unclear.   "
30700|NCT02883881|"     determination if, within a keratoconic population, strong eye rubbing was correlated with     visual acuity, spherical equivalent value, biomicroscopic signs, corneal pachymetry,     keratometry, and tomography classification determinating keratoconus stage.   "
30701|NCT02883868|"     To assess the association between stromal demarcation line after collagen crosslinking (CXL)     for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical     outcomes of CXL   "
30702|NCT02883855|"     The aim of this study to determinate if there is a correlation between visual acuity gain in     patients who underwent a Descemet's stripping automated endothelial keratoplasty (DSAEK)     corneal keratoplasty and the central thickness of the graft.   "
30703|NCT02883842|"     The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to     evaluate the effectiveness of automated mobile phone text message-based intervention for     secondary prevention, including lifestyles modification, medication adherence improvement and     risk factors control among coronary heart disease (CHD) patients with diabetes. The     participants will be randomized into intervention and control groups in a 1:1 ratio. The     intervention group will receive 6 pre-designed text messages per week in addition to usual     care for 6 months, while the control group will receive usual care.   "
30704|NCT02883829|"     Adolescence and emerging adulthood are critical periods during which health outcomes may be     imperiled for youth with Type 1 Diabetes (T1D). Due to the strong presence of alcohol use in     the college environment, college students with T1D may be especially vulnerable to these     risks.      Our goal is to develop preliminary evidence in support of a scalable intervention targeting     diabetes health management and alcohol use avoidance for college youth with T1D. For this     project the investigators will engage at least 120 youth with T1D in college. The study     sample will be drawn from two national, non-profit, peer support based groups: the College     Diabetes Network (CDN) and the TuDiabetes Network.      The study aims to 1) develop and pilot and educational video intervention; 2) determine the     acceptability and efficiency of various web platforms for engaging college students in     completing a survey about their health and alcohol use and to; 3) compare effectiveness of     delivery of a brief intervention delivered by a peer versus a provider. The investigators     plan to engage 120 college youth with T1D in completing a survey about their health knowledge     and alcohol use behaviors.      Baseline survey items will ask participants about knowledge, attitudes, and practices/plans     for diabetes self-management and alcohol use in college. In response to survey items,     participants will provide information on topics including general and disease-specific health     information, as well as attitudes, behavior, beliefs, and knowledge related to alcohol use.     Participants will also respond to questions relating to social support, mental health, and     perseverance and commitment to long term goals.      Following the baseline survey, participants will be presented with a brief educational video     about diabetes self-management and alcohol use risks. Participants will be randomized to     receive one of two educational video interventions. One version will be framed and delivered     from a peer-based source and the other from a provider, content will otherwise be identical.     Participants will receive 2 follow-up surveys; one immediately following viewing the video     and the second two weeks later. Both the immediate follow-up and the 2-week follow-up survey     will test salience, recall, and effects on health knowledge, beliefs and behavioral     intentions.      While the main purpose of the pilot is to ascertain preferences in the absence of preliminary     data, our a priori hypothesis is that peer delivery will have greater impact for this     population.   "
30708|NCT02883777|"     This study is a randomized clinical trial, which will follow and evaluate 120 kidney     transplant recipients over one year. There will be two groups: a control group and the     intervention group. The dietitian visits will happen monthly during the first six months and     twice in the last six months.The intervention group will receive a high-protein and low     glycemic index diet (1,3g/kg/day of protein) and the control group will keep following the     hospital standard protocol. The study assessments (weight, anthropometry and biochemistry)     will be performed during these visits over one year after the randomization period.   "
30717|NCT02883660|"     The purpose of this study is to determine whether patients who have been prescribed     antidepressant medications and have experienced significant adverse effects are more likely     to be poor metabolizers on the CYP450 (CYP2B6, CYP2D6, CYP2C19, CYP3A4/5+) drug metabolizing     enzymes and/or homozygous for the short allele of the serotonin transporter (SLC6A4) compared     to patients who took an antidepressant medication and did not experience significant adverse     effects but also had minimal or no response to the medication. The target medications being     studied include escitalopram, citalopram, paroxetine, fluvoxamine, venlafaxine, duloxetine,     bupropion, vortioxetine, vilazodone, and levomilnacipran only.   "
30709|NCT02883764|"     Employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics     screening program are being offered an opportunity to have their blood fatty acids levels,     especially omega-3 fatty acids [omega-3 index] measured at no charge. At some locations,     participants were offered a single coupon on a 90 day supply of omega-3 capsules. Three     months later, all employees at these locations are given a second opportunity to have their     blood omega-3 levels [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] measured.     The goals are to: 1) survey dietary EPA+DHA intake and omega-3 blood levels of study     population, 2) determine if dietary EPA+DHA intake and omega-3 blood levels change after     people have learned their omega-3 index, and 3) determine if differences in omega-3 index     concentrations can be detected 3 months later between locations receiving information alone     vs information+coupon.   "
30710|NCT02883751|"     Diabetes mellitus is a major public health problem and it is estimated that 300 million     individuals will be affected by the year 2030. Non-diabetic ulcers are one of the most     frequent complications of this disease and, if untreated, can lead to the amputation of lower     limbs. Thus, there has been growing interest in the use of light emitting diode (LED) devices     to accelerate the tissue repair process and lower the cost of ulcer treatment in this     population. The Mandaqui hospital complex is a general, tertiary, teaching hospital that is a     reference center for revascularization surgery and endovascular treatment in Brazil. The aim     of the proposed study is to evaluate the action of LED therapy on the complete healing of     ulcers following minor amputations in patients with Diabetes mellitus. Methods: A     single-center, randomized, controlled, double-blind, clinical trial with two parallel groups     will be conducted following the criteria of the CONSORT Statement. The project will be     registered with www.clinicaltrials.gov. The sample will be composed of 40 patients with a     diagnosis of Diabetes mellitus in follow up at the vascular clinic of Mandaqui hospital     complex who meet the inclusion criteria. The control group (n = 20) will receive traditional     rayon bandages with essential fatty acids and secondary coverage with gauze, which will be     changed on a weekly basis. The treatment group (n = 20) will be submitted to LED therapy (635     nm; 4 J/cm2; 10 minutes) with weekly applications and the ulcers will also receive the     traditional bandage treatment described above. The patients will be followed up until the     complete closure of the ulcer, which will be the primary outcome. The ulcers will be examined     on a weekly basis by a researcher with no awareness regarding the allocation of the     individuals to the different groups and will assess, signs of infection, edema, redness, heat     and the presence of gangrene. Photographs of the ulcers will also be taken for the subsequent     determination of the area. Another researcher with no knowledge regarding the allocation of     the participants will measure the surface of the ulcers with the aid of the ImageJ software     program. The data will be submitted to appropriate statistical analyses. After closure of the     ulcers, the patients will be followed up for a period of six months.   "
30711|NCT02883738|"     The main objective of this study is to identify the superficial muscle groups involved in     gene-related tremor and assess the reduction in the intensity of the tremor after transient     electrical stimulation.   "
30712|NCT02883725|"     The esophageal atresia is a group of birth defects including a break in continuity of the     esophagus with or without persistent communication with the trachea (tracheoesophageal     fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive     ...).      The current prognosis for this ailment is good. However he persists a mortality (<10%) and     significant morbidity, firstly related malformations (heart, kidney, for example), and     secondly with particularly difficult anatomical forms (Forms long defect) .      The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an     estimated ± 2,500 new cases over to 10 years in France.      The current project aims to set up a national registry (Metropolitan France and Dom Tom) to     measure the prevalence of esophageal atresia among live births, phenotypic characteristics,     the circumstances of their diagnosis, and their initial future at short-term during the first     year of life, at which time occurs the vast majority of deaths and complications in this     disease.   "
30713|NCT02883712|"     Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic     drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as     exemplified by some genetic diseases. However, the lack of specific guidelines for the choice     of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large     number of drugs with different and sometimes complex metabolism are challenges for     neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to     pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage     and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more     unrelated with the cytochrome P450 and less generalised adverse events. However, their     metabolism could be more complexe (i.e. the less known Uridine     5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological     adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which     could largely impede the observance and the quality of life even if the number of seizure is     reduced or not. The goal is to determine the predictive and the modulating factors of     pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a     specific analysis (drug by drug) from a cohort of 1000 patients.   "
30714|NCT02883699|"     The TOP Study is a two-stage study on individually tailored endurance and resistance training     prescriptions for breast and prostate cancer patients after the end of primary therapy in     order to optimize training effects.   "
30715|NCT02883686|"     Depression during pregnancy and postpartum is a major public health problem with adverse     correlates and consequences for women and their children; although efficacious treatments for     depression during pregnancy exist, few women receive such care. A widely recognized barrier     to treatment engagement is the lack of effective, available care that is well aligned with     women's treatment preferences. To close the gap between treatment need and receipt among     depressed pregnant women, this study aims to develop and test the effectiveness of     disseminating behavioral activation, an efficacious and acceptable treatment for depression,     using peer delivery for pregnant women with depression.   "
30716|NCT02883673|"     The purpose of this study is to assess the safety and effectiveness of the InPress Device in     treating primary postpartum hemorrhage.   "
30750|NCT02883231|"     To observe the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and     to explore its clinical significance.   "
30751|NCT02883218|"     The purpose of this study is to understand the impact community-acquired sepsis     patients'immunosuppression in early stage to prognosis,including mortality and chance of     secondary infection.   "
30718|NCT02883647|"     The study is to observe the therapeutic effects and long-term follow-up after ending anti-HBV     therapy with nucleos(t)ide analogs in patients with chronic hepatitis b.   "
30719|NCT02883634|"     We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy     applied in a vertebral region-specific or region nonspecific level immediately after     treatment and 3 and 6 months after randomization.   "
30721|NCT02883608|"     Examination of major duodenal papilla (MDP) using a standard forward-viewing     esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the     modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses     a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve     visualization and examination of MDP. The aim of this study is to compare CA-EGD to     side*viewing duodenoscope for complete examination of MDP.   "
30722|NCT02883595|"     The purpose of this study is to determine whether thymosin alpha 1 is effective on improving     monocyte function and has the desired pharmacologic activity for sepsis   "
30723|NCT02883582|"     The purpose for the trial is intended to evaluate safety and effectiveness of an oxyhydrogen     generator with nebulizer in an adjuvant therapy for patients with severe asthma.   "
30724|NCT02883569|"     Purpose: Comparative effectiveness research (CER) between surgical and non-surgical treatment     for patients with low back pain Hypothesis: There will be significant differences in surgical     and non-surgical treatment effect in patients who need operation for herniated intervertebral     disc and spinal stenosis.   "
30725|NCT02883556|"     The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient     with locally advanced or metastatic squamous cell carcinoma of the skin   "
30726|NCT02883543|"     Eligible patients are administered with oral icotinib 125mg three times daily for two months,     in which responsive patients (partial response and stable disease) are randomized (1: 1: 1)     and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent     radiotherapy, or icotinib monotherapy.   "
30727|NCT02883530|"     The Investigators hypothesise that asthma is not a single disease, but a syndrome resulting     from several distinct underlying disease processes known as endotypes. There are     approximately 30,000 genes in humans, and each gene is responsible for the production of a     particular protein. Using a technique called whole genome expression profiling The     Investigators have undertaken a small study looking at the activity of all 30,000 genes in     the airway tissue of people with asthma. This work has identified 3 mutually exclusive     distinct molecular patterns (endotypes) of severe asthma and has identified other potentially     important molecular targets (manuscripts in preparation). In particular,the Investigators     have found that 25-50% of patients have asthma associated with the activity of proteins     called Th2 cytokines (Th2-high asthma). New treatments are in development that target this     pathway. However, the Investigators do not know what is driving severe asthma in patients who     do not express these Th2 cytokines. The aim of this study is to investigate in more detail     the molecular mechanisms driving severe asthma in patients who do not express Th2 cytokines     (Th2-low asthma), so that the Investigators can identify new targets for treatment in this     group. To do this the Investigators will collect airway tissue via a telescope     (bronchoscope), and analyse gene and protein expression in the tissue. The Investigators will     then compare the molecular activity between patients with Th2-high and Th2-low asthma, and     healthy control subjects (data obtained from a parallel study).   "
30728|NCT02883517|"     To evaluate the possibility of detecting cell-free circulating tumoral DNA in potentially     aggressive primary cutaneous lymphomas, the investigator opted to search a representative     tumor sample mutation in the blood of these patients, by digital PCR. Patients with mycosis     fungoides, primary cutaneous T-cell lymphoma helper follicular phenotype and primary     cutaneous diffuse large B-cell lymphoma, leg-type will be included and 4 blood samples will     be collected during 12 months.   "
30729|NCT02883504|"     The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal     for performing an echocardiography in the routine clinical practice. Conflicting evidence     exists about mitral E/e' ratio reliability for predicting high LVeDP   "
30730|NCT02883491|"     The overall goal of this clinical research study is to prospectively assess primary outcomes     related to pulmonary embolism (PE) that occur immediately (within 5 days) and within 30 days.     The secondary goal is to compare validated prediction models and a modified European Society     of Cardiology (ESC) approach that is primarily right ventricle dysfunction (RVD) driven with     clinical risk assessment being secondary, and with primary outcomes of clinical deterioration     within 5 days.   "
30731|NCT02883478|"     Compare different corneal parameters and visual outcome of corneal collagen cross-linking     (CXL) with conventional versus accelerated ultraviolet-A irradiation using riboflavin with     hydroxypropyl methylcellulose.   "
30761|NCT02883088|"     The multicenter observational CLIMA registry has been conceived to explore correlation     between OCT morphology of atherosclerotic plaques located in the left anterior descending     artery with mid and long term clinical outcome.   "
31489|NCT02873598|"     This is a dose escalation trial to evaluate the safety of stereotactic body radiotherapy     (SBRT) delivered in 3 fractions for patients with locally advanced pancreatic cancer (LAPC)     who have received induction chemotherapy (FOLFIRINOX or gemcitabine and nab-paclitaxel).   "
30732|NCT02883465|"     Extubation is a crucial step when patients are being weaned from mechanical ventilator     support. Indeed, the patient has to face an increasing burden imposed to the ventilation     system. The ability to overcome this event will determine the patient survival. A warning     signal could be very useful is this situation. 2 recent studies have shown that measuring     diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population     with a high risk of diaphragmatic weakness, characterized by a high failure extubation     rate. This study aims to verify that this kind of group of patients does exist.   "
30733|NCT02883452|"     Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate     efficacy, PK and safety between CT-P13 SC and CT-P13 IV in patients with active CD or active     UC.   "
30734|NCT02883439|"     The aim of this study is to investigate and to compare the bioavailability of MP29-02 and     fluticasone propionate in nasal tissue after nasal application. This may provide a rational     basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has     demonstrated the efficacy of the twice-daily treatment; however, so far, no data are     available on the local tissue concentrations of MP29-02 after topical application.   "
30735|NCT02883426|"     This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live     attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.   "
30737|NCT02883400|"     To study spironolactone to prevent CNI kidney injury.   "
30743|NCT02883322|"     Objectives: To identify the respective contributions of back-translations and of the expert     committee in the process of cultural adaptation of patient reported outcome with an     experimental design in the adaptation process :      Four translations of a questionnaire will be produced:        -  A simple translation by two translators, who serves as the basis for the three other          translations        -  A translation made with the use of a back-translation.        -  A translation with review by an expert committee.        -  A translation the use of a back-translation and review by an expert committee.      Properties of each translation will be analyzed and compared   "
30744|NCT02883309|"     The patient subjected to hemodialysis has a low physical capacity due to being advanced in     years and the complexity of the process, which is encouraged by family members and caregivers     who lead them to a total dependence. The Intradialytic physical exercise is presented as an     alternative to counteract this functional deterioration of patients with terminal chronic     kidney failure.   "
30745|NCT02883296|"     Main purposes of this study are :        -  Analysis of relapse risk of anal fistulae with prospective follow-up of patients          undergoing pelvic MRI every 6 months for one year. This monitoring also determines if          the presence of path of fistulae visible on MRI during inclusion visit is associated to          increased risk of perianal abscess under infliximab or adalimumab treatment.        -  Evaluation of interest of new magnetic resonance imaging sequences for detection of          persistent anal fistulae under infliximab or adalimumab treatment.      Secondary purposes are:        -  Description of patients with one or more paths of fistulae visible with MRI after at          least one year of treatment with infliximab or adalimumab administered for anal fistulae          and showing a complete healing of fistulae at clinical examination of inclusion visit.        -  Identification of predictive factors (included the presence of paths of fistulae visible          with MRI during inclusion visit) of relapse of anal fistulae during the 1-year-follow-up          after inclusion visit.   "
30746|NCT02883283|"     This study explores the potential for a more rapid onset of pain relief when drug     administration is performed through the epidural needle, a technique of epidural loading that     provides a rapid and reliable level of labor analgesia without the disadvantages of a     combined spinal-epidural, and could add a valuable new tool to anesthesiologists.   "
30747|NCT02883270|"     This study investigates the effects of Robotic-assisted gait training in non-ambulatory     patients after Guillain-Barré syndrome.The participants are randomly divided into two     groups.Patients of the treatment group receive robotic-assisted gait training,while the     contorls receive conventional rehabilitation.   "
30748|NCT02883257|"     The purpose of this study is to locate clinical markers (for example, interviews,     questionnaires, and computer tasks) and biological markers (for example, physiological,     blood-based, or electroencephalography measurements) that predict response to cognitive     behavioral therapy for depression.   "
30749|NCT02883244|"     The aim of this study is to evaluate the efficacy of a new interdental cleaning device     (Soft-Picks Advanced), as compared to a leading brand floss; and, how ease of use can promote     the establishment of a hygienic routine of cleaning interproximal spaces.   "
30752|NCT02883205|"     The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left     ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing     life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still     diagnosed late. This delay in diagnosis is due to the non-specificity of clinical,     electrocardiographic and echocardiographic disease, but also by a certain ignorance of this     pathology in the medical community. The importance of early diagnosis of Fabry disease and     heart disease is well established: enzyme replacement therapy is most effective when     instituted early, before the onset of irreversible damage such as fibrosis. With the blotter,     we now have a simple and robust screening tool for Fabry disease, achievable consultation.     Targeted educational interventions to physicians have shown their effectiveness in improving     the screening and diagnosis of rare diseases. We offer a prospective observational type     before / after study, which aims to assess the value of an educational brochure for     cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.   "
30753|NCT02883192|"     Cesarean section is a frequent procedure in the obstetric surgery. The most widely used     anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal     anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population.     The aim of the study is to investigate the effect of the preventive use of Ondansetron on the     prevention of hypotension   "
30754|NCT02883179|"     The aim of our study is to compare the analgesic effect of topical application of     lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal     tears.   "
30755|NCT02883166|"     Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly     blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of     abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor     bio-availability and is fully converted to the active moiety abiraterone. Abiraterone acetate     tablets are administered at a fixed oral dose of 1000mg QD in a fasted state in combination     with 10mg prednisolon daily.      Abiraterone acetate has a low solubility in aqueous media and a low permeability. The     bioavailability of abiraterone acetate is significantly influenced when ingested with food.     Ingesting abiraterone acetate with a low fat or a high fat meal resulted respectively in a 5-     or 10-fold increase in AUC0-∞. The high and low fat FDA meals used in these food effect     studies differ largely from breakfasts taken in everyday life (ca. 800-1000 cal). A     continental breakfast contains 160 to 320 calories of which 25-50% is fat, is more compatible     with a normal lifestyle and therefore easily sustainable in daily practice. However, the     effect of a continental breakfast on the absorption of abiraterone is unknown yet.     Furthermore, increasing healthcare costs are a growing concern in all developed countries.     Therefore effort should be invested to keep anticancer treatment affordable. A food     intervention resulting in a better absorption and enhanced exposure to abiraterone, can lead     to a reduced dose, which could significantly impact health care costs for a tumor which is as     prevalent as metastatic prostate cancer.      Therefore the investigators want to perform a bioequivalent study to investigate what dose of     abiraterone with a continental breakfast equals the dose of 1000mg taken in fasted     conditions.   "
30756|NCT02883153|"     Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is     expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT     (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of     patients with RCC. The aim of the present study is to show the impact of the     Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.   "
30757|NCT02883140|"     Non tumor salivary gland diseases are common and include sialadenitis, sialadenosis, stones,     stricture and ductal dilatation, anatomical abnormalities. A radiological examination is     required in order to sign the diagnosis, locate precisely the lesions and define the     therapeutic strategy. Cone beam computerized tomography (CBCT), because of its accessibility     and the possibilities it offers in terms of image processing, is a potential alternative to     the conventional sialography and to the MRI sialography, considered as a gold standard     procedure. Our comparative study, aims to evaluate the diagnostic performance of the 3D-CBCT     sialography compared to MRI sialography, in patients with non tumor ductal salivary diseases.   "
30758|NCT02883127|"     The primary goal of this case control study is to investigate the effect of implementation of     motivational interviewing with focus on diet and weight gain in addition to the routine     treatment on prevention of excessive gestational weight gain and fetal growth in pregnant     women with type 2 diabetes.      Design: Prospective cohort study where an unselected cohort of all pregnant women with type 2     diabetes are offered intervention with motivational interviewing in addition to routine     treatment in the period 2015-2017. For comparison a historical cohort (2013-2015) treated     with routine treatment only will be studied. With an inclusion period of 2 years, each cohort     is expected to include 150 participants. The women in the study group will receive one-to-one     coaching based on the principles of motivational interviewing, every second week throughout     the pregnancy. Both cohorts receive the same routine care for pregnant women with type 2     diabetes. An appropriate GWG is targeted. Primary outcome measures are maternal gestational     weight gain and the infants Large for Gestational Age.   "
30759|NCT02883114|"     This study is to evaluate the effect of multiple doses of itraconazole, the potent cytochrome     P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following a single     dose administration in healthy subject.   "
30760|NCT02883101|"     Number of Patients:      Study group - Bronchiectasis that is not attributable to Cystic fibrosis        -  Group 1 - Pulmonary Rehabilitation        -  Group 2 - Standard care      Sample size - 20 in each arm      Study Design:        -  Randomised controlled trial (RCT)      All patients who qualify for the study will undergo a detailed evaluation. Baseline     assessment will include the following parameters:        -  Anthropometry        -  Pulmonary Function Tests and Respiratory muscle strength        -  Cardiopulmonary Exercise Testing (CPET)        -  Six Minute Walk Test (6MWT)        -  Severity of dyspnoea (Dyspnoea scale)        -  Limb muscle strength        -  Inflammatory markers in the serum - C-reactive protein        -  Quality of Life      Patients will then be randomized (using table of random numbers) to either the pulmonary     rehabilitation group or the standard arm group. After 8 weeks of pulmonary rehabilitation,     patients will again be reassessed by the aforementioned tools.   "
30762|NCT02883075|"     Multiple studies have compared spinal anesthetic performed supine versus lateral, with     varying results, in parturients having elective cesarean section. Needle positioning during     spinal placement has also been examined. No positioning techniques have demonstrated     definitive superiority for hemodynamic stability.      Investigators propose that following spinal placement in the sitting position if the patient     is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic     changes caused by sympathectomy related to the subarachnoid block can be avoided.      This is the first study to examining the influence of position changes after spinal     anesthetic placement in the sitting position, which includes hemodynamic variables not     previously studied including cardiac output, (total peripheral resistance) TPR, TSF, and     pulse pressure variation (PPV).   "
30763|NCT02883062|"     This randomized phase II trial studies how well carboplatin and paclitaxel with or without     atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III     triple negative breast cancer. Monoclonal antibodies, such as atezolizumab, may block tumor     growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as     carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the     tumor smaller and reduce the amount of normal tissue that needs to be removed.   "
30765|NCT02883036|"     Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm companies with the BCR-ABL     fusion gene encoded by the Philadelphia (Ph) chromosome. The BCR-ABL fusion protein(the     formation of the chimeric gene BCR/ABL on chromosome 22 and a reciprocal ABL/BCR on     chromosome 9,it has no expanded name) plays key role on CML leukemogenesis by activating its     downstream signaling pathway of survival and proliferation. Imatinib, a targeted competitive     inhibitor of a BCR-ABL tyrosine kinase, changed the clinical treatment and prognosis of CML.     As its optimized generation, other tyrosine kinase inhibitors (TKIs), dasatinib and nilotinib     have more potent anti-leukemic activity and less side-effect. However, acquired resistance to     TKIs is one of the main obstacles to effective CML treatment and is involved in gene     amplication of ABL tyrosine kinase point mutations. The outcomes of patients with these ABL     tyrosine kinase point mutations have linked to worse prognosis and higher mortality     generally. Metabolic adaptations are common in cancer cells, and cancer cells become more     dependent on mitochondrial biogenesis. Tigecycline, as a broad-spectrum antibiotics, inhibits     mitochondrial biogenesis as its an interesting side-effect.In recent study,researchers     indicated that tigecycline can eradicate cancer stem cells by targeting mitochondrial.Here,     the investigators test tigecycline's anti-leukemic activity to chronic myeloid leukemia in     vitro.   "
30779|NCT02882854|"     Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post     Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of     post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea     scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and     the other group will receive a similar appearing placebo (containing no drug) to take orally.   "
30766|NCT02883023|"     Capillary malformations (port-wine stains) consist of abnormally developed capillary blood     vessels in the skin. To date, laser therapy is the only widely accepted treatment modality     for capillary malformations, but this therapy has a suboptimal effect in approximately 50-60%     of patients.      Intralesional bleomycin injections (sclerotherapy) are a common effective treatment option     for vascular malformations with blood vessels with larger diameters. However, bleomycin     cannot be injected adequately in the small sized vessels of capillary malformations. The use     of an electric field over the tissue (electroporation) may solve this problem: it increases     cell membrane permeability and therefore promotes localized delivery of drugs, within     (endothelial) cells.      Electroporation in combination with bleomycin sclerotherapy ('electrosclerotherapy') may     therefore offer new therapeutic options for capillary malformations. This proof of principle     study aims to explore the effectiveness, safety and feasibility of this potential treatment     option in a within-patient-controlled pilot study.   "
30767|NCT02883010|"     Surgical Site Complications (SSC's) are responsible for increased morbidity in patients     undergoing surgery resulting in prolonged length of stay in the hospital while increasing     treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on     closed incisions has been reported in the literature to reduce SSC's including Surgical Site     Infections (SSI's), with many promising studies in general surgery, including some studies     using single use NPWT. However, to date, there are very few randomised controlled trials     (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may     be discharged from hospital earlier, with the negative pressure incision management in place.     This has implications in terms of cost savings for the health care system and enables the     patient to be able to return to their normal daily routine more quickly. The hypothesis of     this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as     compared to standard care in patients undergoing colorectal procedures.   "
30768|NCT02882997|"     This study will determine the feasibility of using an interactive computer game to elicit     repetitive practice of paretic arm movements in the homes of community dwelling stroke     survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.   "
30769|NCT02882984|"     A multi-center phase III randomized controlled study to evaluate the efficacy of     Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from     non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI     concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS     (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive     function, quality of life (QoL) and adverse events.   "
30802|NCT02882555|"     The hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise.     The purpose of this study is to determine if a short muscular exercise inhibits the cough     reflex induced by capsaicin inhalation.   "
31490|NCT02873585|"     A comparison of caries detection rates between conventional intraoral bitewing radiography     and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source     array. The secondary objective is to assess participants experience with the s-IOT device.   "
30770|NCT02882971|"     Currently, there is no observational pain scale for use in the outpatient setting for adult     patients. An observational pain scale can allow for objective measurement of pain in patients     over time and after treatment without the bias associated with self-report. Currently chronic     pain patients are asked to rate their pain many times throughout their care, often over     years. This introduces a bias in reporting as a pain a person is currently experiencing will     seem more severe then a remembered pain event. A behavioral pain scale would allow for an     objective measurement of pain that is reliable across multiple raters and comparable over     time, which can help in judging the success of pain treatments.   "
30772|NCT02882945|"     To explore the possible implications of HLA-DRB1*04 alleles in patients with type 2 DM and     macroangiopathy   "
30773|NCT02882932|"     Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using     normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load     after giving lavage with SOS solution and in other group normal saline. SOS is a high level     disinfectant, non-flammable and no special training is required to handle it.   "
30774|NCT02882919|"     Health risk screening in adolescent primary care is infrequently performed and results are     rarely followed by targeted intervention. In response to the need for screening-linked     interventions, the study team has developed and optimized a web-based, electronic     Personalized Motivational Feedback tool referred to as Check Yourself v2.0 Based on     motivational interviewing, a technique to mobilize personal change, Check Yourself is     designed to promote healthy choices for the multiple behaviors relevant to adolescents.   "
30775|NCT02882906|"     One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized,     hyperirritable points in the skeletal muscles that are associated with palpable nodules in     muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the     same clinical characteristics as active MTrPs but they do not provoke spontaneous pain.     Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic     neck and shoulder pain.   "
30776|NCT02882893|"     The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows     Feet Lines(CFL).   "
30777|NCT02882880|"     To determine the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep     bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.   "
30778|NCT02882867|"     It is well known that participation in sports activities as a youth has several health     benefits, but at the same time, studies report that the risk is high to obtain injuries     related to participation. There is, however, increasing evidence that many of these injuries     can be prevented if necessary measures are taken. Prospective studies are therefore needed to     be able to plan and carry out measures to prevent the occurrence of injuries. The overall aim     of the project KLUB is to study the prevalence and incidence of injuries among athletics     youths aged 12-15 years. A particular focus will be placed on identifying factors associated     with injury occurrence.   "
31336|NCT02875587|"     The aim of this study is to compare the efficacy of calcium gluconate infusion versus     cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients     pretreated with GnRH agonist long protocol who are at high risk for OHSS.   "
30780|NCT02882841|"     The study is a multicenter, international descriptive study with a bio-collection in 300     evaluable Crohn's disease patients to be processed after usual biological tests via     bioinformatics tools.      At this time, this study has no impact neither on treatment nor on disease diagnostic, these     will be based on usual medical practices and is no investigational product associated with     the conduct of this study.   "
30781|NCT02882828|"     Tools have been developed in our unit to calculate the inter-dose AUC (Area Under Curve) of     immunosuppressive drugs (ISD) based on a limited number of blood concentrations (i.e., blood     samples) using Bayesian methods. Since 2005, we have implemented these tools in an expert     system and made them available to the transplant community through our very successful ISBA     (Immunosuppressive drugs Bayesian dose Adjustment) website.      Briefly, we first need to develop a population pharmacokinetic model using rich     pharmacokinetic (PK) profiles (about 10 samples per patient over the dosing interval). The     model developed can then be used for inference of ISD PK parameters in new patients using     Bayesian estimation. Bayes' theorem is based on conditional probability: individual PK     parameters are estimated based on the known PK parameters in the population (mean and     distribution), given the dose and concentrations observed in a patient. Our previous studies     have shown that a limited sampling strategy (LSS) based on 3 samples collected within the     first 3 hours after drug intake can estimate adequately the interdose AUC of ISD. In the     present study, the AUC0-24h and the recommended dose will be calculated using Bayesian     estimators previously developed using PK data from the clinical trials run by Veloxis, and     proposed to the clinicians via a dedicated website comparable with ISBA.   "
30782|NCT02882815|"     The purpose of the study is to collect more data about performance and safety of the device     called IrisFITTM PFO occluder. This data will be used to help more patients who will accept     treatment with this device in the future.      Patients will undergo routine examination, procedure and follow-up. Related data will be     collected and kept in a way that patient info is well protected.   "
30803|NCT02882542|"     NOTE: This is the third of in total 7 sub-studies related to the Ethics Committee of the     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6     arms, in total 350 participants will be assessed in all 7 sub-studies.      General study information: This is a randomized, cross-over, quantitative study, which     investigates physiological variables, mood, and affect of healthy participants in response to     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored     light only, or are additionally asked to solve cognitive tasks during the colored light     exposure. Primary aim is to measure the change in several physiological variables, mood, and     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is     negligible and comparable to the risk during daily life.   "
30783|NCT02882802|"     Research has consistently shown that Veterans with PTSD are more likely to experience higher     levels of anger and commit aggressive acts compared to Veterans without PTSD. Given the     significant negative impact that anger and aggression can have on the lives of Veterans,     their families, and society at large, there is a great need to examine novel interventions     that could decrease anger and aggression risk with this population. Mindfulness may be one     such technique, given its effectiveness in assisting individuals in regulating difficult     emotions and in decreasing physiological reactivity, which have both been implicated in PTSD     and aggression perpetration. Findings showing that a mindfulness intervention is effective in     reducing anger and aggressive behavior would be relevant for Veterans with PTSD experiencing     such difficulties and would help prevent the detrimental consequences that can come from     anger and aggression among these individuals.   "
30784|NCT02882789|"     Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage     form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary      • To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose   "
30785|NCT02882776|"     This study aims to examine the effect of ginger beverage consumption on platelets activity in     apparently healthy Saudi adult volunteers.      As for the Saudi population, consumption of powdered ginger dissolved in hot water is a     common practice. Accordingly, in this study, it is tempting to speculate the effect of this     form of ginger consumption, given in separate time points per day, on platelet aggregation     profile by using platelet aggregation analogues. If positive results were obtained, the herb     could provide natural protection against the development of platelet aggregation     complications and could be a potential alternative to aspirin, used for improving blood     circulation and hematological pathophysiologies in diseased individuals.   "
30786|NCT02882763|"     ZEPPELIN (Zurich Equity Prevention Project with Parents Participation and Integration) is a     longitudinal, randomized controlled intervention study. The main objective is to examine the     effectiveness of the early intervention program Parents As Teachers (PAT) in psychosocially     disadvantaged families. This includes four aims:        1. Identification of children at risk at an early age, using an interdisciplinary network;        2. Investigation of the acceptability of the program by the parents;        3. Evaluation of the intervention process and efficacy during and immediately after program          implementation;        4. Evaluation of the efficacy in terms of child academic performance.   "
30787|NCT02882750|"     This study will monitor the effect on patients reported outcomes (PROMs) of VATS resection     and SABR for NSCLC delivered at the Leeds Cancer Centre The investigator will support with     this information the Shared Decision Making (SDM) process.      300 consecutive patients will be followed up from prior the treatment to 12 months     afterwards, administering multiple questionnaires (EORTC QLQ C-30 and LC-13, PSQ-18, Decision     Self-Efficacy Scale) by a remote web-based system.      Deliverable:        1. Differences after VATS resections or SABR in terms of physical and psychological          symptoms, quality of life and satisfaction        2. Patient perspectives of the Shared Decision Making Process.   "
30821|NCT02882308|"     OPHELIA (OlaParib in patients with HEad and neck squamous-celL carcInomA) trial is a Greek,     investigator-initiated, randomized open-label window-of-opportunity phase II study. Patients     with operable histologically documented squamous-cell carcinoma of the oral cavity,     oropharynx, hypopharynx or larynx will be randomized between combination with cisplatin and     olaparib, monotherapy with olaparib or no treatment, before standard treatment.   "
35556|NCT02820376|"     The purpose of this study is to assess the degree of agreement of the measurement of     differential renal function in living donors by CT (computed tomography) and SPECT (single     photon emission computed tomography).   "
30788|NCT02882737|"     This project is part of several studies exploring situations, where glucagon potential has     lesser glucose elevating effect. Exercise can be one of these situations as exercise may     reduce liver glycogen depots.      The investigators aims are:        1. To compare the increase in plasma glucose after 200µg glucagon given either after          exercise or after resting for 45 minutes.        2. To determine whether a subcutaneous glucagon injection just before exercise has a          greater impact on hepatic glucose production and thereby is superior to an injection          after exercise in preventing hypoglycemia during and two hours after exercise.        3. To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at          either the abdominal wall or on the upper arm.   "
30789|NCT02882724|"     Background: It has been shown that adults with Multiple sclerosis (MS) have less leg strength     than their peers, as well as impaired balance, which has led to an increased prevalence of     falls in this population.The purpose of this study was to assess the effects of 8-weeks     aquatic exercise training in balance, endurance and speed in women with MS.      Methods: In this semi-experimental study, 32 women with clinically-definite     relapsing-remittent MS who were registered through the Isfahan MS association volunteered for     this study. They randomly selected an aquatic exercise (n = 17) and control (n = 15) groups.     Aquatic exercise group completed a 8-week aquatic exercise training program consisted of     three sessions per week, each session lasting 45 to 60 minutes 50 to 75 percent of their     maximum heart rate reserve on 20-25 degree centigrade's, whereas the control group was     instructed to maintain their current lifestyle. The balance of angry was surveyed with using     of Berg analyze, speed and endurance 6 minutes walking test before starting of exercise     program and after 4 weeks and at the end of 8 weeks was analyzed. The obtained data's were     analyzed using analysis of variance with repeated measures.   "
30790|NCT02882711|"     The primary objective of this study is to determine the effectiveness of serial infusions of     intravenous (IV) ketamine in adults with treatment resistant depression (TRD).   "
30791|NCT02882698|"     The game Marble Maze Classic® will be used, in which the participants have to move the mobile     phone to conduct a virtual marble through a maze design. The investigators will evaluate 100     individuals (50 with Down Syndrome-DS and 50 with typical development-TD) and divide both     with DS and TD into group 1 and 2, where each group consists of 25 participants, with group 2     using a maze design totally opposite to group 1.   "
30792|NCT02882685|"     This study compares Roux-en-Y gastric bypass with single anastomosis gastric bypass in a     randomized prospective setting. This study also adresses the issue of bile reflux after MGB.   "
30804|NCT02882529|"     NOTE: This is the second of in total 7 sub-studies related to the Ethics Committee of the     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6     arms, in total 350 participants will be assessed in all 7 sub-studies.      General study information: This is a randomized, cross-over, quantitative study, which     investigates physiological variables, mood, and affect of healthy participants in response to     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored     light only, or are additionally asked to solve cognitive tasks during the colored light     exposure. Primary aim is to measure the change in several physiological variables, mood, and     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is     negligible and comparable to the risk during daily life.   "
30793|NCT02882672|"     This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could     improve adiponectin and cardiovascular disease risk factors in overweight coronary heart     disease patients. Patients were included in the study if: they were approved to do so     following a physical, physiological and psychological test; did not take part in regular     physical activity; had stable heart failure for at least 3 months. Exclusion criteria     included: a history of surgery within the preceding 4 months; had an unstable angina, acute     phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy,     exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure     more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease;     exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health     problems that prevented maximum effort on the treadmill test. Target population included of     all patients with a history of myocardial infarction and diagnosis of congestive heart     failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary     heart disease patients were randomly assigned to either an eight-week, three times weekly     exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place     at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40     minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging,     flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.   "
30794|NCT02882659|"     The primary objective of this study is to evaluate the safety of autologous dendritic killer     cell (DKC) in patients with metastatic solid tumor and to evaluate the maximum tolerated dose     (MTD) of DKC. The primary endpoint of safety evaluation includes physical examination,     assessment of vital sign, laboratory test, concomitant medication, and adverse event (AE).     The secondary endpoints regarding efficacy includes the generation of tumor specific immune     response by detecting CD3+ CD8+ CD69+ IFN-gamma+ T cells, and the improvement of quality of     life   "
30808|NCT02882477|"     Patients who are genetically diagnosed with the recently reported and rare Wolfram syndrome     type 2 ( WFS2) and have the degenerative and symptomatic disease including signs such as     diabetes, platelet aggregation defect or visual problems will be asked to participate in this     study. Knowing the pathomechanism of WFS2 with rapid cell death, after doing baseline     investigations to asses the severity of their disease, the participants will be offered a     chelator therapy with in addition to the antioxidant Acetylcystein, in diabetic patients an     Incertin (GLP-1 ) therapy will be offered as well. The baseline investigations will be     repeated after 2 months and after 5 months of therapy in order to asses the progression of     the disease and to show if the chelator and anti oxidant therapy and in diabetic patients the     GLP-1 therapy could stop the progression of the disease.   "
30809|NCT02882464|"     Miller Class I Gingival Recessions (GR) have been treated by using Coronally Advanced Flap     (CAF) with Platelet Rich Fibrin membrane (PRF membrane) or Connective Tissue Graft (CTG). The     aim of this study was to evaluate the effect of different multiple layers of PRF membranes     for the treatment of GR and compare the results with CTG procedure.   "
30795|NCT02882646|"     In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the     frequent strategy used over bilateral ones. However, the clinical need for bilateral training     is supported by evidence that shows that unilateral training of the impaired limb does not     automatically restore bimanual coordination and function. Increased focused is needed on     developing more robot-assisted therapy that can train the impaired arm bilaterally and     unilaterally. Controlling these robots is often difficult and requires a better understanding     of the coupling effects of the left and right hand before and after a stroke. There is a need     to develop robot-assisted therapy devices that can address coupled and uncoupled bimanual     movements as well as symmetry as well as asymmetry in context of human bimanual actions along     with the intermanual division of labor in various ADL tasks. This study focuses on bilateral     training and the use of bio-inspired control algorithms to understand impairment and recovery     on Bimanual Activities of Daily Living (ADLs) by stroke subjects in terms of the arm     kinematics. Healthy subjects and those with hemiplegia due to a stroke or cerebral palsy will     be evaluated by a member of the research team and asked to perform a battery of tasks to test     the viability and usability of a bilateral robot system called BiADLER, which allows patients     to complete daily tasks with varying levels of assistance to adapt task performance to each     individual subject's performance. Subjects will to provide feedback to the researchers on     their observations and thoughts about the therapy devices.   "
30796|NCT02882633|"     The purpose of this study is to compare lumbar plexus block to fascia iliac block done in     adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid     consumption, and quality of recovery 48 hours post operatively will be used for comparison.   "
30797|NCT02882620|"     Recent improvements in colorectal cancer (CRC) incidence, mortality, stage at diagnosis, and     survival in the general U.S. population have been attributed to routine screening with prompt     removal of polyps, early detection, and timely and appropriate treatment. American     Indians/Alaska Natives (AI/ANs) have not experienced improvements in CRC related outcomes and     are significantly less likely than non-Hispanic Whites to receive recommended CRC screening.     The purpose of this three-arm randomized controlled trial is to determine the efficacy of     interventions designed to enhance CRC screening. The study also uses mixed methods to     finalize the intervention and to determine promoters and barriers of screening. The study     also conducts process evaluation to determine cost-effectiveness of the interventions,     fidelity of study implementation, and to develop plans to sustain and scale-up the     intervention model. The study will determine the efficacy of serially implemented     interventions of graded intensity for increasing CRC screening using the fecal immunochemical     test (FIT) in accordance to recommended guidelines among average risk American Indians (AIs)     aged 50-75 residing on reservations in rural Southwestern U.S. Serial implementation refers     to offering routine screening, irrespective of response to an earlier invitation, in     concordance with guidelines which recommend annual FIT testing between ages 50-75. The FIT is     most appropriate because it is an approved, high sensitivity fecal occult blood test and is     available at Indian Health Service (IHS) and tribal health facilities where resources to     provide screening colonoscopy are limited. The study is a collaborative effort between the     Albuquerque Area Indian Health Board (100% Indian-owned and operated), six Pueblo Tribes in     rural Southwestern U.S., and the University of New Mexico. Findings from this research could     lead to an immediate increase in CRC screening and ultimately reduce CRC burden among AIs,     thus addressing national and tribal priorities of reducing CRC disparities among AIs.   "
30798|NCT02882607|"     The purpose of this study is to test the efficacy of an innovative, culturally relevant,     community-based peer group intervention to increase young rural Malawian women's     preconception behaviors to optimize their reproductive health. The study uses a longitudinal,     two group (two-arm) design with a delayed control group.   "
30799|NCT02882594|"     The overall objective of the study is to improve the experience for pediatric patients     undergoing anesthesia inductions. The specific objective for this proposal is to establish     whether the CIBA tool demonstrates inter-rater reliability and concurrent validity with the     Induction Compliance Checklist.   "
30800|NCT02882581|"     The general purpose of the trial is to investigate whether metformin is taken up into the     breast tumor. Studies in the last few years have shown an effect of metformin on cell     proliferation on breast cancer. It is though unclear whether the effect on tumor is direct,     indirect or a combination of the two. The investigators plan to:        -  investigate if metformin is taken up in breast cancer using our novel 11C-metformin          tracer and positron emission tomography (PET)        -  investigate whether the uptake is correlated to the amounts of organic cation          transporters (OCT1-3, MATE 1 &2 and PMAT) using quantitive polymerase chain reaction          (qPCR).   "
30801|NCT02882568|"     Improve knowledge of the immune response to sepsis in obese patients. Define immunological     and genetic prognostic factors of severe infections which can motivate a change in the     therapeutic attitude   "
30805|NCT02882516|"     NOTE: This is the first of in total 7 sub-studies related to the Ethics Committee of the     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 5     arms, in total 350 participants will be assessed in all 7 sub-studies.      General study information: This is a randomized, cross-over, quantitative study, which     investigates physiological variables, mood, and affect of healthy participants in response to     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored     light only, or are additionally asked to solve cognitive tasks during the colored light     exposure. Primary aim is to measure the change in several physiological variables, mood, and     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is     negligible and comparable to the risk during daily life.   "
30806|NCT02882503|"     Incidental pancreatic solid or cystic lesions are diagnosed with increased frequency due to     the widespread use of abdominal cross-sectional imaging to investigate unrelated symptoms.     Lesions such as neuroendocrine tumors (NET), mucinous cystadenomas and intraductal papillary     mucinous neoplasms (IPMNs) have the potential of malignant transformation. The standard     treatment of solid or cystic pancreatic lesions with malignant potential has been surgical     resection, with lesions in the pancreatic head requiring a Whipple resection whereas     pancreatic tail lesions are treated with distal pancreatectomy. Both types of resection carry     significant morbidity and mortality. The study would like to outline the feasibility, safety,     adverse events and early results of endoscopic ultrasound (EUS) - radiofrequency ablation     (RFA) in pancreatic neoplasms.   "
30807|NCT02882490|"     This is a randomized controlled trial to assess the efficacy of a parent training program to     control disruptive behaviors in children with Tourette Syndrome.   "
30845|NCT02881996|"     The objective of this study is to evaluate two standard post-operative pain regimens     routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators     hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with     narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia     (PCA) to oral pain medications.   "
30810|NCT02882451|"     Pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (IBS)     and functional disorders of the biliary tract. In this study, pinaverium bromide was compared     with Vitamin C for the facilitation of bile duct and pancreatic duct cannulation in patients.     The primary outcome was successful deep bile duct cannulation and pancreatic duct canulation.     The second outcome was the major papillary orifice,bile juice flow from the papilla, time to     achieve deep bile duct cannulation, fluoroscopy time for deep bile duct cannulation,the     appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla,     time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic     duct cannulation in the pinaverium bromide group versus Vitamin C group.   "
30811|NCT02882438|"     Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a     fungal infection of the feet and it is easily spread. Oral therapy is usually used for     chronic conditions or when topical treatment has failed. The aim of this study is to prove     the antifungal and antibacterial activity of Ginko Biloba (GKB) & Glucosamine (GL) as     separate material or both in combination.   "
30812|NCT02882425|"     The primary purpose of this phase 1 study is to investigate the absolute bio-availability of     a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the     blood when administered as an oral tablet (ACT-293987) compared to an intravenous     administration in healthy subjects.   "
30813|NCT02882412|"     Long-term use of opioids for chronic pain is a growing health and social problem, mainly     because of the risk of dependence. Buprenorphine/naloxone is used as substitution therapy for     opioid dependence. This substitution therapy in patients with opioid dependence lessens     withdrawal symptoms and craving. There is limited research on the effectiveness of     buprenorphine/naloxone in patients with chronic pain and iatrogenic opioid dependence. The     primary aim of this study is to investigate the effectiveness of buprenorphine/naloxone in     patients suffering from chronic pain and an iatrogenic induced dependence on opioids. This     study will investigate the effects of opioid substitution by buprenorphine/naloxone in     patients suffering from chronic pain using long-term opioids, with pain and withdrawal     symptoms as primary outcome measures. Secondary outcome measures will be craving, substance     use, psychiatric comorbidity and quality of life.   "
30814|NCT02882399|"     The pubic and abdominal pathology is common among athletes. It leads to a shutdown of     physical activity for several months, and requires rehabilitative care, or surgery for a     permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of     sports.   "
30815|NCT02882386|"     The aim of this study is to investigate the amino acid kinetics in blood after a bout of     strength training and ingestion of different milk protein supplements (native whey, whey     protein concentrate 80, hydrolysed whey, microparticulated whey and milk) The investigators     hypothesize that native whey will give a faster and higher rise in blood concentrations of     leucine compared to the other milk protein supplements.   "
30816|NCT02882373|"     The goal of this clinical research study is to learn if L-arginine can help control side     effects of anti-cancer drugs such as high blood pressure, protein in the urine, and kidney     problems. L-arginine is a nutritional supplement and will be compared to a placebo in this     study.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
30818|NCT02882347|"     Post hepatectomy liver failure (PHLF) is a serious medical problem could lead to patient     death, however, definite treatment strategy has not been established. The liver is a     regenerating organ and the possibility of PHLF could be reduced when the appropriate liver     regeneration is guaranteed.      Portal flow has known to be important during liver regeneration. Low portal flow cannot     induce proper regeneration, contrary, excessive flow increase shear stress in the hepatic     sinusoid resulting liver failure.      Various medications has been used in malignant liver cirrhosis to reduce portal pressure.     Among them, somatostatin has been used modulating portal flow reducing portal and sinusoidal     pressure.      In this study, the investigators administrate somatostatin at a rate of 3.5ug/kg/hour to PHLF     patients (prothrombin time < 50% and serum total bilirubin > 2.9mg/dl after liver resection)     until recovery from liver failure. For assessment of the recovery of liver failure, the     investigators evaluate aspartate transaminase (AST), alanine transaminase (ALT), serum total     bilirubin and prothrombin time periodically after administration of medication.   "
30819|NCT02882334|"     Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures     during writing. Limited finger independence during writing manifests as difficulty     suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also     have difficulty in fine control of grip force. However, some previous studies indicate     positive effects of individual finger movement training in WC although these studies lacked     enhanced visual feedback of activations in 'stationary' fingers. The investigators have     recently developed the Finger Force Manipulandum which quantifies the forces applied by the     fingers in different tasks. This method is sensitive for detection and quantification of     small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary'     fingers can be displayed on-line providing enhanced feedback on independence of finger     movements. The aim of this study is to test the effectiveness of finger individuation     training using the FFM to improve symptoms in WC patients.   "
30820|NCT02882321|"     This clinical research study has 2 parts: dose escalation and dose expansion.      The goal of dose escalation in this clinical research study is to find the best dose of     IACS-010759 that can be given to patients with relapsed or refractory AML.      The goal of dose expansion in this clinical research study is to learn if the dose of     IACS-010759 found in the dose escalation part of the study is the best dose to use in future     studies using IACS-010759 in patients with AML.      The safety and tolerability of this drug will also be studied.      This is the first study using IACS-010759 in humans.      This is an investigational study. IACS-010759 is not FDA approved or commercially available.     It is currently being used for research purposes only. The study doctor can explain how the     study drug is designed to work.      Up to 48 participants will take part in this study. All will be enrolled at MD Anderson.   "
30903|NCT02881242|"     This phase II trial studies how well trametinib works in treating patients with     hormone-resistant prostate cancer that is growing or getting worse and has spread to other     parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
30822|NCT02882295|"     Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts     writing. It leads to partial or complete inability to use the hand only during the     handwriting gesture. It is characterized by the appearance of cramps or spasms of certain     muscles of the hand and/or forearm.      Clinical scales currently use for the assessment of WC fail to accurately reflect changes in     the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections     and / or retraining therapy).      The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information     in terms of speed and precision of handwriting gesture. This timed handwriting test is to     follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the     time in seconds required to carry out the zigzag path and count the number of errors (output     path and contacts with obstacles). The investigators propose to validate the ZZTT for the     assessment of the handwriting gesture of WC.   "
30823|NCT02882282|"     The goal of this clinical research study is to compare pembrolizumab to standard of care     observation (no treatment) in controlling oral pre-malignant lesions and IENs. The safety and     tolerability of pembrolizumab will also be studied.   "
30824|NCT02882269|"     A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant     chemotherapy with postoperative chemotherapy in patients with resectable locally advanced     colon cancer   "
30825|NCT02882256|"     Patients seen in the ED with either a laceration, minor head injury, or urinary tract     infection will be randomized to one of two groups. Both groups will receive the standard     written discharge instructions; in addition, one group will watch video discharge     instructions. Each patient will be asked to complete a short survey with questions related to     the discharge instructions received in the ED, and will be called 5-7 days after the ED visit     to ask questions about discharge instructions and the ED visit.   "
30826|NCT02882243|"     This investigation will provide safety and effectiveness information on the use of the     FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by     evaluating:        -  Safety as measured by the rate of serious operative and post-operative complications.        -  Patients' quality of life, measured by health-related quality of life questionnaires up          to 24 months following the procedure, as compared to patient's baseline.   "
30827|NCT02882230|"     The frequency of neurological and psychiatric complaints for participants taking rilpivirine,     elvitegravir, or dolutegravir reaches on average 20—30% during clinical trials. The inclusion     and exclusion criteria for enrolling people living with HIV are at times so selective and the     subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and     ambiguous that one cannot extrapolate these particular research results to practicing     medicine. These adverse events negatively affect the patient's quality of life and ultimately     his or her good adherence to treatments.      This study aims at assessing the prevalence and at describing the neurological and     psychiatric adverse events related to these drugs.   "
30828|NCT02882217|"     The study focusses on the evaluation of safety and tolerability of the XC8. The design of the     study involves sequential dosing of cohorts (group of volunteers), taking increasing doses of     the product after receiving conclusion and recommendation for further continuation of the     study from the Dose Escalation Committee.   "
30830|NCT02882191|"     To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to     support commencing a Phase III Clinical Study   "
30831|NCT02882178|"     Cabazitaxel is a second line chemotherapy drug recently approved for the treatment of     metastatic castration-resistant prostate cancer. To investigate whether the precautions for     the use of cabazitaxel (contraindications, hepatic function, premedication for     hypersensitivity, prophylactic treatments, dose and dose adjustment, as well as conditions of     administration) are respected in routine practice, an observational cohort study will be     implemented in 32 oncology centres of South-West region of France (CABOBS study). The primary     objective of this cohort is to evaluate the conformity of cabazitaxel prescriptions with the     Summary of Product haracteristics (SPC) in clinical practice (indications and monitoring     methods) and according to the conditions of use. Panel of experts were convened to assess the     conformity of prescription of cabazitaxel with a Delphi consensus method. The Delphi method     is most suited to areas where a limited number of evidences are available to enable a     recommendation or guidelines to be drawn. Moreover, all the evaluated items came from an     official document provided by the EMA, the SPC of cabazitaxel. Thus, it is expected from the     experts to select the most relevant items. In the frame of the CABOBS study, this method will     allow to select items of the SPC list according to their importance, and to define the     primary objective of conformity to cabazitaxel conditions of use.   "
30832|NCT02882165|"     Chronic Obstructive Pulmonary Disease (COPD) is a condition resulting from environmentally     induced lung damage e.g. cigarette smoking and air pollution which, over time, causes     individuals to suffer from symptoms including chronic cough and progressive breathlessness.     In the UK COPD is predominantly caused by cigarette smoking which may have occurred decades     before the symptoms appear and the disease is diagnosed.      The aim of this study is to identify those COPD patients who currently have milder disease     and to investigate whether a detailed, medical assessment which has time to assess all     aspects of their care will improve their lung health and general wellbeing.      COPD is a major cause of disability and death in the UK, with around 835,000 people currently     diagnosed with the disease and an estimated further two million people who suffer from     symptoms but do not yet have a diagnosis(1). Approximately 25,000 people each year die from     COPD in England and Wales (2), with the disease accounting for 5.4% of all deaths in England     and Wales in 2013 (3). Predominantly in its later, more severe stages, COPD causes an     enormous symptom burden to patients, and accounts for up to half of emergency admissions to     already overstretched hospital services in England (4).      People with COPD, with a past history of smoking, are at higher risk of other medical     problems such as heart disease and stroke(5). Being breathless and having multiple physical     health problems can also lead to mental health problems such as anxiety and depression(5).     This means it can be challenging to provide this group of people enough time to fully assess     and treat all their problems, particularly due to current pressure on the length of GP     appointment times.      Whilst COPD is treatable, it is not curable, and emphasis on early diagnosis and intervention     provided a key part of the strategy for COPD published by NHS England in 2012(6). With early     diagnosis, the opportunity is provided to intervene with the aim of improving symptoms and     exercise tolerance, reducing the risk of exacerbations, slowing deterioration and prolonging     quality of life.   "
30833|NCT02882152|"     Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia     and postoperative bleeding from intrathecal morphine with the continuous femoral and a     single-shot sciatic nerve blockades.   "
30904|NCT02881229|"     This study aims to develop a clinical database of patients presenting with vulvar complaints     in order to comprehensively assess the presentation and current trends in management of     vulvar disease.   "
30834|NCT02882139|"     Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP)     and ventricular fibrillation (VF)) represent a major event in the clinical history of a     patient and they can lead to hemodynamic instability and sudden cardiac death (SCD).     Recurrences of ventricular arrhythmias and electrical instability have exponentially     increased in the last decades and a new clinical entity called electrical storm (ES) has     emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more     sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia     lasting 12 hours or more and that does not respond to treatments.      Most of the patients presenting ES are already implanted with an ICD. This is due to 3     factors: first, patients with ICD implant are at higher risk to develop ventricular     arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records     and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not     be detected. Third, and more important, the device gives the possibility to survive to an     arrhythmic episode, making it possible for the patient to experience an ES. The incidence of     ES is debated in different studies and ranges from 10 to 60% in patients with ICD for     secondary prevention and from 4 to 7% in patients with ICD for primary prevention.      The aim of the ELECTRA registry is twofold:        1. To create an international registry on clinical features, optimal therapy, ablation          strategy, prognosis and the effect of ICD programming on patients with ES.        2. To use the data derived from the registry for a prospective, observational study on          mortality and rehospitalization rate in patients with ES.   "
30835|NCT02882126|"     This is a multicenter, open-label trial to evaluate the safety of continued therapy with     subcutaneous Remodulin® in subjects with pulmonary arterial hypertension (PAH) who complete     the CVT-CV-003 study. The study will include about 50 subjects at up to 10 clinical trial     centers in China who completed all required assessments in the CVT-CV-003 study. Study visits     for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until     the study is discontinued by the sponsor.   "
30836|NCT02882113|"     This study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated     clinical trial to assess the influence of CYP3A5 polymorphism on liver function abnormality     and the trough level change after conversion to Advagraf® in liver transplant recipients.   "
30837|NCT02882100|"     This study is powered to prospectively evaluate the relative effectiveness of adjuvanted     trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization,     and functional decline in a nursing home population in the U.S., compared to the commercially     available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).   "
30839|NCT02882074|"     The purpose of this study is to evaluate whether patients receiving human albumin for plasma     volume replacement during cardiac surgery have improved postoperative endothelial function     compared to patients receiving 6% hydroxyethyl starch solutions. The postoperative     endothelial function, measured with peripheral arterial tonometry as reactive hyperemia index     (RHI) within 2 hours following surgery, will be compared in cardiac surgical patients     randomized to receive human albumin or 6% HES solutions for intraoperative volume     replacement. Within two hours of arrival to the ICU peripheral arterial tonometry using     EndoPAT will be performed. In a subset of 40 consecutive patients the investigators will     perform additional EndoPAT measurements to describe the expected changes that occur in     endothelial function during the perioperative period (baseline, early postoperative and 24     hours postoperative) using RHI.      This study will also determine whether human albumin 5% reduces plasma biomarkers of     endothelial and glycocalyceal damage by measuring plasma concentrations of syndecan 1 and     endocan at baseline (before surgery), and 1 and 24 hours following surgery. Blood samples     will be taken on the morning of the surgery, within one hour of arrival to the intensive care     unit (ICU), and 24 hours after surgery or within 2 hours before discharge from the ICU (three     times altogether). These samples will be used to measure the plasma concentrations of two     biomarkers that measure endothelial injury.   "
30840|NCT02882061|"     Neck pain is a very common diagnosis and physical therapy, specifically thoracic     manipulation, has been shown to be an effective treatment. Thoracic manipulation, which     involves a quick thrust type push to a segment of the midback region of the spine, has been     shown to decrease pain and improve function in individuals with neck pain. However, it is not     known if there is a test that will accurately identify individuals with neck pain who would     respond more favorably to thoracic techniques. The Cervical-Thoracic Differentiation Test     (CTDT) is a test used clinically to differentiate pain originating from either the cervical     (neck) or thoracic (midback) regions of the spine in individuals with neck pain. It has also     been speculated that specific unloading tests, where a tester selectively unloads a portion     of the weight of the cervical or thoracic spine through manual distraction may help determine     who will respond more favorably to thoracic treatment. To the best of our knowledge, despite     widespread clinical use, these tests have not been tested for validity or reliability at this     time. Therefore, the purposes of this research are to assess the reliability and criterion     referenced validity of the CTDT and unloading tests, as well as examine the relationship     between tests and baseline subject characteristics.   "
30841|NCT02882048|"     This study is to compare two groups undergoing opioid weaning as ordered by their referring     physicians. One group will undergo the standard opioid weaning process and the other group     will have the addition of the NADA Protocol to the weaning process.   "
30842|NCT02882035|"     66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet     Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other     group an opioid free one. The hypothesis of this study was that opioid free anesthesia     improves the postoperative quality of recovery of anesthesia.   "
30843|NCT02882022|"     This study is an investigation into the effect that CPAP has on the pressure in the middle     ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of     CPAP pressure delivered via a full face mask. These measurements will be used to determine     optimal levels of CPAP to affect individual's middle ear pressure, particularly those with     negative middle ear pressure due to Eustachian tube dysfunction.   "
30844|NCT02882009|"     The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to     assess pain following subcutaneous (SC) administration of gantenerumab as a     high-concentration liquid formulation (HCLF) at different injection speeds. The total     duration of the study for each healthy participant will be up to approximately 21 weeks.   "
30846|NCT02881983|"     Background:      Difficulties in assigning and identifying emotional states, or to regulate the emotional     costs are recognized as one of the major factors of relapse. This study aimed to evaluate the     emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term     alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy     control participants (C) in a positive and negative emotion induction protocol.      Main aim:      Evaluating the emotional regulation deficits assessed with physiological indicators (heart     rate variability, electrodermal response, pupil diameter) and clinically in presentations of     visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's     (AUD) patients with short and long term abstinent compared to a control group of healthy     subjects. The investigators are particularly interested in the evolution of heart rate     variability considered as a good marker of vulnerability to AUD.      Secondary objectives:      Studying the relationships between physiological measures and clinical variables such as     behavioral indicators and self-reported assessment of cognitive and emotional skills among     the three groups (STA, LTA and C).   "
30847|NCT02881970|"     Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain     asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal     damage and loss.      Currently, only total or partial body hypothermia can partially prevent cell loss. However,     no treatment exists to restore neuronal functions.      Cord blood stem cells are a promising treatment for the near future.      The primary objective of this study is to test the safety and feasibility of a curative     treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.      The secondary objectives are to test the efficacy of this curative treatment with cell with     neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum     timing of cell preparation administration   "
31065|NCT02879123|"     This trial aims at collecting standardized data concerning the early neurological clinical     recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.      Although this outcome is a major issue of patients' prognosis, it is rarely collected at this     stage of their follow-up.   "
30848|NCT02881957|"     Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized     clinical trials within an intensive care unit (ICU) environment. Despite these findings,     there have been no studies examining the impact of hypovitaminosis D in specialized     neurocritical care units (NCCU). Given the often significant differences in the management of     patients in NCCU and more generalized intensive care units there is a need for further     inquiries into the impact of low vitamin D levels in this specific environment. This study     proposes a randomized, double-blinded, placebo-controlled, single center evaluation of     vitamin D supplementation in the emergent NCCU patient population. The primary outcome will     involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes,     including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge,     complications and quality-of-life metrics. Patients will be followed for 6 months     post-discharge.   "
30849|NCT02881944|"     Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are     poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut     bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the     colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by     production of chemicals that influence Veteran's intestines which then result in reduced     disease symptoms.      The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP     (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.   "
30850|NCT02881931|"     The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information     coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion     through self-report. The purpose of this study is to identify real or potential comprehension     or usage problems with questionnaire items or response options. Through a process of     structured cognitive de-briefing with HDGEC participants and companions, independently,     followed by qualitative analysis, the final phrasing of the individual items and response     options for the scale will be generated. Depending on the results of the first round of     cognitive pre-testing, additional rounds of cognitive pre-testing may be required.   "
30851|NCT02881918|"     The purpose is the description of anti-tumor immune responses in general and according to     clinical stage and disease free survival (DFS: survival without recurrence (local or     distant)) in patients with Head & Neck Squamous Cell Carcinoma      Secondary purposes are:        -  Study of relationship between anti-tumor immune response and qualitative (yes/no) and          quantitative (number) presence of circulating tumor cells (CTCs);        -  Study of relationship between qualitative (yes/no) and quantitative (number) presence of          CTCs and clinical stage as well as DFS        -  Study of relationship between anti-tumor immune response and clinical stage as well as          DFS.   "
30852|NCT02881905|"     There is a significant difference between CM LOC and ball attachment, when considering the     peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives     are to determine if CM LOC attachment improves the peri-implant soft tissue response and     decreases the marginal bone loss around implant when compared to conventional ball attachment   "
30853|NCT02881892|"     The aim of study was to evaluated the correlation between plasma levels, dialysate appearance     rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in     CAPD patients.   "
30854|NCT02881879|"     The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy     (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or     without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy     parameters will be evaluated: immunoglobulin level changes and skin reactivity.      It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5     participating spanish sites.      Primary endpoint of the study is to assess the safety and tolerability of subcutaneous     immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis     with or without mild asthma sensitized to house dust mites      Secondary objective is to evaluate the indirect immunotherapy efficacy through the     measurement of immunoglobulin level changes and cutaneous reactivity   "
30905|NCT02881216|"     This study sought to compare procedural performance of a new coronary stent generation, that     is already available in Germany, with hitherto established current drug-eluting stents.   "
30855|NCT02881866|"     This study evaluates the effect of inhaled furosemide on different types of breathlessness     relief in healthy volunteers. Each volunteer inhaled mists of either furosemide or a control     substance on 3 occasions per day on 2 separate days. On one day they performed one     breathlessness test which creates an 'urge to breathe' known as air hunger (AH) and the other     day they performed a breathlessness test which increases the sense of work/effort (WE) of     breathing. The study is double blinded so neither the volunteer or the research knows which     mist is being inhaled.   "
30856|NCT02881853|"     This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and     multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in     healthy subjects and in subjects with atopic disease.   "
30857|NCT02881840|"     Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass     balance recovery, metabolite profile, metabolite identification and pharmacokinetics of     14C-labelled APD421   "
30858|NCT02881827|"     The purpose of this study is to obtain experimental data on the possible changes that saliva     may suffer when brought to low-level laser therapy protocols for analgesia in the masseter     muscle, because this be on the Parotid salivary gland.   "
30859|NCT02881814|"     Introduction: Physiotherapist usually uses a clinical examination, including auscultation, an     analysis of blood gasses and chest imaging to determine the indication for chest     physiotherapy, to choose the treatment protocol and evaluate the efficacy of the management.     Lung ultrasound (LUS) presents greater accuracy than chest X-ray in the diagnosis of lung     deficiencies interesting the physiotherapist. So, it could allow the physiotherapist to     determine the indication for chest physiotherapy and thus avoid unnecessary or inappropriate     treatments. No study has evaluated the impact of LUS on clinical decisions in chest     physiotherapy in ICU patients.      Objective: To evaluate the impact of using the results of lung and diaphragm US on clinical     decisions in chest physiotherapy in hypoxemic patients hospitalized in ICU.      Method: The physiotherapist carries out a clinical examination and analyses the complementary     tests (chest X-ray, chest CT-scan and blood gasses if available). Following the examination,     he will put forward one or several hypotheses concerning the respiratory deficiency and will     confirm or not the indication for chest physiotherapy. If respiratory physiotherapy is     indicated, the physiotherapist will specify the protocol.      A lung and diaphragm US will be done following the evaluation of the clinical     physiotherapist, and will make it possible to answer the question: are the results of the     lung and diaphragm US compatible with the hypotheses put forward? The LUS report will be     given to the clinical physiotherapist. He will specify the respiratory physiotherapy protocol     according to the results of the US-scan.      The modification of the clinical decision will be assessed with the Net Reclassification     Index (NRI).      Expected results: We expect that decisions for chest physiotherapy will be modified by LUS.     The expected benefit for patients is therefore that they will be given a chest physiotherapy     protocol that is better suited to the type of respiratory deficiency they are suffering from.   "
30860|NCT02881801|"     This study aims to describe the pattern of active and sedentary time in survivors of a     critical illness, at three time points during their hospital admission (awakening in the ICU     after ≥ 5 days of mechanical ventilation, discharge to ward and discharge from hospital).      The specific research objectives are to        1. Determine the duration of active and sedentary parameters including time and bouts in 24          hour periods        2. Examine changes in the active and sedentary parameters including time and bouts between          time points of awakening and both ICU and hospital discharge.        3. Conduct a preliminary examination of relationships between activity and sedentary          behaviour metrics with measures of muscle strength, physical function and hospital          length of stay.   "
30861|NCT02881788|"     Minnesota Healthy Brain Initiative will be an ongoing project that aims to increase awareness     regarding brain health and its maintenance as well as increasing awareness of the impact of     alcohol on brain function. In the immediate future, we hope to obtain data from a non-injured     normative, diverse population represented by the state fair patrons.   "
30862|NCT02881775|"     The purpose of the study is to identify things that influence the ability to turn on the     thigh muscle (quadriceps). The thigh muscle tends to be under active with knee     osteoarthritis, which may make it difficult to strengthen the muscle. The investigators are     also testing a new technology called repetitive transcranial magnetic stimulation (rTMS) to     determine whether it may help turn up activity in the under active thigh muscle immediately     after its application. rTMS uses a targeted pulsed magnetic field, similar to what is used in     an MRI (magnetic resonance imaging) machine to send an electrical signal from the brain to     the thigh muscle.   "
30863|NCT02881762|"     This is a single-site, longitudinal, open-label, interventional study for evaluating the     effect of maraviroc on hepatitis C viral levels in patients infected with both hepatitis C     and human immunodeficiency virus (HIV) and taking antiretroviral therapy for HIV.   "
30864|NCT02881749|"     The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low     dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous     T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT     (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation     that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a     maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance     drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and     percent body surface area measurements (%BSA). Furthermore, subjects will be followed     histopathologically through skin biopsies performed at the screening visit, immediately after     observation period, one month after the start of the maintenance period, and twelve months     after the start of the maintenance period (4 biopsies total).   "
30876|NCT02881593|"     For twenty years, as for other surgical disciplines, new minimally invasive techniques have     been developed with the main goal the reduction of muscle trauma associated with the     surrounding roads classic and reduce morbidity linked to this one.      More recently, minimally invasive methods dedicated to spinal surgery were established, for     the treatment of herniated discs initially, then for narrow lumbar canals.      The canal release on minimally invasive fusion, using a tubular system for muscle retraction     is a new technique that has proven effective: post operative pain reduction of hospital stay     and blood loss.      The objective of the study is to investigate the quality of ductal release in these minimally     invasive fusions.      Main objective of the study: Evaluation of the quality of the release of post scanners     operative minimally invasive arthrodesis      Secondary Objectives: Assessment rates/types of early complications of technical Minimally     invasive - early postoperative results (postoperative pain, analgesic consumption, length of     hospital stay, blood loss) - in clinical outcomes in the short and medium term decompression     after minimally invasive fusion.   "
30906|NCT02881203|"     This study investigates the Breathe Well device to test whether it is superior to the     existing treatment standard of the Varian Realtime Position Management (RPM) system in     assisting patients with deep inspiration breath hold.   "
30865|NCT02881736|"     Clinical assessment of motor and sensory deficits is still today largely based on tests that     do not permit any precise quantification. However, robotic technologies, coupled with     neuroimaging techniques constitute new tools to assess sensorimotor functions that could     allow to conceive neurorehabilitation protocols better adapted to the neurological impairment     of each patient and to her/his specific recovery profile.      The goal of this project is to contribute identifying the factors that determine functional     recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our     research on two factors that contribute in a complementary way to motor control: 1) the     processing of proprioceptive informations, and 2) the processing of movement-execution     errors. In this purpose, we will combine psychophysical methods that allow to precisely     quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More     specifically, we will exploit experimental protocols that have been developed in basic     research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely     quantify motor and proprioceptive deficits in stroke patients. Then, we will link these     behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation     task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI)     completed by diffusion tensor images (DTI) in order to achieve a finer description of the     cerebral lesions.      The present study will include two experimental parts, respectively centered on the     proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution     errors (Part 2).      Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present,     deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially     to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in      proprioception for action  are more determinant than deficits in the conscious sense of     position (classically tested in clinics). In this purpose, we will collect three sets of     behavioral data, in chronic stroke patients and healthy control participants, respectively     intended to assess a) motor deficits, b) troubles in conscious sense of position, and c)     deficits in proprioception for action. To better document the neuronatomical substrates of     these different types of deficits. In this purpose, we will link the obtained behavioral data     with the results of detailed analyses of the lesions of the tested stroke patients.      Anomalies in the processing of movement-execution errors in stroke patients : We will assess     movement-execution error processing in stroke patients, in order to test the idea that     anomalies in error processing might contribute to motor deficits in stroke patients. In this     purpose, we will record an electrophysiological correlate (ERP) of movement-error processing     during a motor adaptation task. We will analyse the relation between the modulation of this     ERP and motor performance. We will also examine the relation between these two sets of data     (behavioral and electrophysiological) and the behavioral data collected during the first part     of the study (Proprioceptive deficits). This will provide us with insight into the     relationship between proprioceptive deficits and cinematic error processing. As in the first     part of the study, we will link the observed electrophysiological and behavioral anomalies     with the results of a detailed analysis of the anatomical lesions of the tested patients.   "
30866|NCT02881723|"     The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep     quality remains poor. Because of a high level of risk of developing an Obstructive Sleep     Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of     the impact on quality of life is important in order to propose preventive and therapeutic     solutions to these patients.   "
30867|NCT02881710|"     Multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations     of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care patient.   "
30868|NCT02881697|"     The target of rapamycin complex 2 (TORC2) is an evolutionarily conserved serine/threonine     protein kinase that controls growth and metabolism. In mammals (including humans), mammalian     TOR complex 2(mTORC2) contains mammalian TOR (mTOR), RICTOR, mSIN1 protein, and mLST8 gene.     In an animal model, the adipose-specific rictor knockout (AdRiKO) mouse, systemic insulin     resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet     (HFD)-induced obesity or aging. To find a molecular link between adipose mTORC2 and systemic     insulin resistance, investigators have already performed transcriptomics and proteomics     analysis on visceral white adipose tissue in a mouse model. The aim of the study is to     confirm a molecular link between adipose mTORC2 and systemic insulin resistance in humans.   "
30869|NCT02881684|"     This research project will provide insight into the efficacy and safety of aspiration therapy     in the management of obesity and its comorbidities in the Asian population, and will     determine if there is a role for this novel endoscopic device in the treatment algorithm of     obesity in the investigators' local regions.   "
30870|NCT02881671|"     Identification of genes involved in congenital atrioventricular block and progressive Cardiac     Conduction Disease.   "
31281|NCT02876315|"     Many older adults do not get enough zinc, vitamin C and vitamin D, and this can be related to     decreased ability to fight infection. The purpose of this research study is to determine if     taking a multivitamin/mineral supplement every day for 12 weeks will increase the ability of     immune cells in blood to kill bacteria.   "
30871|NCT02881658|"     This is a local, single-center, two-arm, randomized, double-blind, placebo-controlled     clinical trial that examines the LDL-C-lowering effect of the consumption of a soya beverage     enriched with plant sterol for 3 weeks. This study also examines if there is other     health-benefits by consuming the plant sterols fortified soya beverage in terms of serum     total triglyceride, total and HDL cholesterol, other cardiometabolic risk factors and     musculoskeletal-related traits including handgrip strength, gait speed, peak expiratory flow     rate, bio-impedance and body balance.   "
30872|NCT02881645|"     The purpose of this study is to assess the effectiveness of a best practices nursing protocol     in intensive care units on the occurrence of critical incidents compared to the common     practices.   "
30873|NCT02881632|"     A cohort observational study to characterise baseline Structured Light Plethysmography (SLP)     outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM   "
30874|NCT02881619|"     Objectives: This study will determine the effectiveness of preemptive administration of     etodolac on risk and intensity of tooth sensitivity caused by in-office bleaching using 35%     hydrogen peroxide.      Materials and Methods: Fifty patients will be selected for this triple-blind, randomized,     cross-over, placebo-controlled clinical trial. Etodolac (400 mg) or placebo will be     administrated in a single-dose 1 hour prior to bleaching procedure. The whitening treatment     with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval. Tooth     sensitivity will be assessed before, during and 24 hours after the procedure using analog     visual and verbal scales. Color alteration will be assessed by a bleach guide scale 7 days     after each session. Relative risk to sensitivity will be calculated and adjusted by session;     while comparison of overall risk will performed by McNemar's test. Data on the sensitivity     level for both scales and color shade will be subjected to the Friedman, Wilcoxon and     Mann-Whitney tests, respectively (α = 0.05).   "
30875|NCT02881606|"     Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1     presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM     (CAD/NAM). The aim of the study is to compare between short term clinical effects of both     interventions as regards alveolar alignment, nasal esthetics and interlabial gap.   "
30887|NCT02881450|"     Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this     study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January     2012 with capture-recapture design using several independent sources of case     identification.   "
30907|NCT02881190|"     A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered     intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.   "
30877|NCT02881580|"     The surgical management of spinal deformities especially in adults is complex. The     conventional surgical treatment of these deformations is a scope arthrodesis of the spine.     The quality of the result depends on many variables such as the choice of the vertebrae to     fuse, location and the number of implants, the type of material used or the type of     correction maneuver used.      All these variables affect the surgical outcome and may be involved as a modifiable risk     factor for possible postoperative complications. The study proposes to focus on the     junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK) 1.     Their prevalence in adults ranges from 20% to 43% depending on the series (Yang and Cheng,     2003; Yagi, King and al.2012).      The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower     plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra     proximal not instrumented (Glattes and al.2005) 4; this measure is being compared to the pre     operative data.      Either the CJP are asymptomatic and do not require revision surgery (Yagi King and al.2011) 5     either they are and thereby generate a revision surgery (Kim Bridwell and al.2008; Watanabe     Lenke and al.2010) .      Several factors may potentially influence the development of the CJP. Among them, age,     preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid     instrumentation, correction forces applied during surgery, sagittal balance pre and post     operative degeneration joint capsules, etc. There are few studies on the identification and     analysis of these risk factors; literature gives only single-center studies on small samples     10 with a single surgical procedure. Review articles describe the incidence and risk factors     of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to     this day.      The aim of this study is to determine the incidence of occurrence of postoperative kyphosis     proximal junctional and identify risk factors for developing this major complication of a     multicenter population of scoliosis operated an extensive fusion.   "
30878|NCT02881567|"     The primary objective of the study is to evaluate the effects of treatment with daclizumab on     the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple     Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due     to safety concerns. The secondary objectives of this study in this study population are to     evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse     activity including the annualized relapse rate (ARR) and the proportion of participants     experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related     outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in     participants previously treated with natalizumab.   "
30879|NCT02881554|"     This pilot trial studies how well single photon emission computed tomography (SPECT)/computed     tomography (CT) with technetium Tc-99m sulfur colloid works in measuring liver function in     patients with liver cancer that has or has not spread to other place in the body who are     undergoing radiation therapy or surgery. Diagnostic procedures, such as sulfur colloid     SPECT/CT scans, may measure normal liver tissue before, during and after treatment and help     doctors plan better treatment for liver cancer patients.   "
30880|NCT02881541|"     Evaluate the complement of patient care course in the development of proctology outpatient     surgery (CAP) by providing:        -  An additional preoperative nurse consultation day hospital        -  And a phone call from a nurse at D + 1 of the operation      This corresponds to a reinforced support.   "
31068|NCT02879084|"     This study investigates the variations in the retinal nerve fiber layer (RNFL) thickness     during uncomplicated anterior and intermediate uveitis, respectively. The objectives are to 1     ) confirm the RNFL thickening during an uncomplicated anterior uveitis as described in the     literature, 2) measure the RNFL thickness during an uncomplicated intermediate uveitis     specifically and 3) describe the variation in time of RNFL thickness during the two types of     uveitis.   "
30881|NCT02881528|"     The autoimmune diabetes ACCELERATOR PREVENTION TRIAL (adAPT) is based on the accelerator     hypothesis. The trial is designed to establish whether metformin, an oral hypoglycaemic agent     that is known to reduce insulin demand in type 2 diabetes (T2D), can do the same in children     at risk of type 1 diabetes (T1D) and thereby prevent disease.      The first phase of adAPT will screen participants aged 5-16 years (inclusive) for     islet-related autoantibodies who are the siblings or offspring of individuals diagnosed with     T1D before the age of 25years in Scotland and England.      There are four principle islet-related antibodies associated with T1D. The presence of two or     more confers a 40% risk of developing T1D in five years. While the presence of none or one     antibody carries a similar risk for developing T1D to the general population (1 in 500 in     5years).      It is anticipated that 5% of those screened will be identified as double-antibody positive,     these participants will be invited to join the intervention phase of the study - randomised     controlled trial (RCT). Up to 200 eligible subjects could be identified by screening with a     minimum of 90 being enrolled into the RCT phase.      adAPT is a proposed three stage project. The current protocol defines the screening phase,     Stage 1 and seamless entry into Stage 2. Screening will identify children and young people at     high risk of developing T1D and invite them to participate in Stage 1 which will involve a     minimum of 4 months treatment with either metformin/placebo, however Stage1 treatment will     run seamlessly into Stage 2. Stage 1/2 treatment will last up to 21 months (to accommodate     15months screening, 4 months treatment and 2 months analysis). Post Stage1 analysis/ late     Stage 2 participation will last up to 36 months (participants enrolled early into Stage 1     will have the longest intervention).      During the Stage1 participants will be tested on three occasions (baseline, month 1 and month     4) for metabolic response using a 5-point mixed meal tolerance test (MMTT). Testing will     continue in Stage 1/2 with 3 visits further visits at months 8, 12, 18. Late Stage 2 visits     will occur on months 24, 30 & 36.      Participants will be invited to continue into Stage 3, taking treatment up to 60 months post     analysis of Stage 1 and associated protocol amendment and additional consent.   "
30883|NCT02881502|"     Program： Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe     Asthma Aim：The early prediction of severe asthma, early intervention on the disease, reduce     the family and the national finance.      design:This study is a single center randomized controlled trial designed by the Department     of respiratory medicine, Xijing Hospital, as the main research unit.Compare the case     group(severe asthma group and mild-and-moderate asthma group) and control group(healthy     control group) by detecting the activity of MPO、NE、MMP-9 and ECP in the peripheral blood and     the activity of HDAC2 in PBMCs of patients.      case:60      Case selection:      Inclusion criteria: age 18-75 years old; diagnosis of asthma was clear; informed consent was     signed.      Exclusion criteria: poor compliance; cognitive ability is low; psychiatric disorders need to     be combined with psychotropic medication.   "
30884|NCT02881489|"     The goal of this study is to investigate the safety and tolerability of autologous bone     marrow-derived mesenchymal stem cells administration in the individuals with diagnosed     amyotrophic lateral sclerosis.   "
30885|NCT02881476|"     The goal of this study is to investigate the safety and tolerability of allogeneic Wharton's     jelly-derived mesenchymal stem cells administration in the individuals with diagnosed     amyotrophic lateral sclerosis.   "
30886|NCT02881463|"     Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks     such as rising from a chair. Therefore interventions aimed at improving muscle strength and     sit-to-stand task performance are very important for these patients. The effect of exercise     programs, including home exercise programs (HEP), on muscle strength, joint pain and function     is well known and widely researched, yet not many studies have investigated the effect of an     HEP on electromyographic activity (EMG) of muscles when performing everyday tasks, such as     rising from and sitting on a chair. The aim of this study was to investigate effect of     prehabilitation in women with severe knee joint OA scheduled for knee joint arthroplasty     (TKA).   "
30888|NCT02881437|"     Most immunodeficiencies are related to severe immunoglobulin deficiencies which require     lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity     of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or     subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV     infusions or have difficulties with venous access. No head-to-head data are available to     directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration     frequencies from daily up to every other week dosing while HyQvia is indicated for infusion     frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after     switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks   "
30889|NCT02881424|"     Background:      Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic     outcome relies on relapse prevention which seeks to identify high risk situations and     individual's response to these situations especially the emotional response to social     environment. Alcohol-dependence also induces cognitive impairments leading to social     cognition impairments increasing the risk of relapse.      Familiarity is a key process in social interactions: it induces the feeling of prior     knowledge of a stimulus without remembering consciously its identity. Followed by a second     process based on the contribution of contextual information (recollection) familiarity allows     face recognition.      Main aim:      Study of familiarity for faces in alcohol-dependence      Secondary objectives:      Highlighting correlations between familiarity impairments and clinical outcomes   "
30890|NCT02881411|"     The main aims of this preliminary research are to determine if combined self-soft tissue     therapy (SSTT) alongside an established 6 week FMS Coping Skills Programme (FCSP) is a     feasible and acceptable treatment approach for FMS. All participants on the six week FCSP     will be randomly allocated to a control (FMS Coping Skills Programme) or intervention group     (FMS Coping Skills Programme plus SSTT). All participants will be assessed for outcome     measurements at the start of the feasibility study, at six weeks and three months after     completion.      This feasibility study hypothesis is that the SST approach will be acceptable to FMS patients     and that the combined 6 week FCSP (hands off) and SSTT (hands on) will be beneficial. This     feasibility study will inform a larger randomized controlled trial (RCT) on this combined     treatment approach to FMS.   "
30891|NCT02881398|"     The primary objective of this investigation was to assess the impact of new mobile health     devices on health outcomes among patients with rheumatic and structural heart disease in a     resource limited area. To achieve this aim the investigators utilized smartphone-connected     devices such as the smartphone-ECG, activity monitors, connected blood pressure devices and     pocket-sized and handheld ultrasound. The main question asked in this investigation is if     mobile health assessments accelerates medical-decision-making and if it shortens the time to     definitive therapy.   "
30892|NCT02881385|"     Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer     inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between     humans and ventilators,making people uncomfortable and prolonging weaning time.Some     ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it     will make the transforming more synchrony with humans.Our prospective observational study     will prove the superiority of the auto cycle function.   "
30893|NCT02881372|"     This is a single-center, prospective, pilot clinical trial in which children ages 3-17 years     with eosinophilic esophagitis (EoE) who have a known food that triggers EoE flares receive     oral desensitization with that specific food antigen, followed by reintroduction of that food     into the diet. The purpose of this study is to investigate the safety and feasibility of oral     desensitization in children with EoE so that, if determined to be safe, can be repeated on a     larger scale to determine efficacy.   "
30894|NCT02881359|"     This study will assess the effectiveness of commercially available LifeSeal® Kit as measured     by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low     and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will     be offered to participate   "
30895|NCT02881346|"     This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice     with regards to effectiveness and convenience of application to psoriasis plaques on body and     extremities. In addition the profiles of patients prescribed Enstilar® will be described, and     preceeding, concomitant and follow-up management will be mapped. The study will be conducted     in about 100 dermatology clinics all over Germany,   "
30896|NCT02881333|"     Currently, for a patient with intellectual disability without a recognizable syndrome (most     cases), the way to diagnosis is often long, tedious and expensive because different     approaches are used one after the other to identify structural variants (duplications,     deletions and other) and point mutations (sequencing of one or more candidate genes). The     development of high-throughput sequencing techniques (next generation sequencing: NGS) has     drastically increased the detection of point mutations offering the possibility to test a     large number of genes simultaneously. NGS also shows a huge potential in detecting structural     variants. The objective of this research is to assess the sensitivity of a simultaneous     detection of point mutations and structural variants by NGS approaches. This would bring     together in a single step the equivalent of performing an array-Comparative genomic     hybridization (CGH) analysis plus performing a targeted sequencing of candidate genes.     Investigators will compare two approaches for this simultaneous detection: a targeted     enrichment of candidate genes coding regions using probes covering these regions associated     with a backbone of genomic probes, an approach that could be implemented immediately in     diagnostic at the hospital, and a whole genome sequencing (WGS), that is currently a too     expensive tool for routine diagnosis but that should be the approach used in the future.     Investigators will compare these two approaches to the traditional one: CGH array + WGS. The     implementation of a one step strategy to detect both types of mutations (punctual and     structural) would accelerate and improve the access of patients to a molecular diagnosis.   "
30897|NCT02881320|"     The primary objectives of this study are to evaluate the steady state pharmacokinetics (PK)     for bictegravir (GS-9883) and confirm the dose of bictegravir/emtricitabine/tenofovir     alafenamide (B/F/TAF) fixed-dose combination (FDC) in HIV-1 infected, virologically     suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years of age). This     study will also evaluate the safety and tolerability of B/F/TAF FDC through Week 24 in HIV-1     infected, virologically suppressed adolescents and children.   "
30908|NCT02881177|"     The purpose of this pilot study is to determine the tolerability, feasibility, and     preliminary effectiveness of intranasal oxytocin administration prior to motivational     enhancement group therapy sessions on laboratory-based measures of addiction, social     connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with     men (MSM). The investigators propose a randomized, double-blind, study of intranasal oxytocin     versus placebo 40 IU prior to each of six Motivational Interviewing Group Therapy (MIGT)     sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use disorder.   "
30909|NCT02881164|"     To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic     response and satiety in subjects with type 2 diabetes mellitus under intensive insulin     therapy.   "
30910|NCT02881151|"     This study involves the treatment of cognitive impairment secondary to moderate to severe     brain injury using central thalamic deep brain stimulation. Although all patients will     receive stimulation continuously through an implanted pacemaker-like device, half of the     patients will have the device deactivated during a blinded assessment phase. The device will     be reactivated following this assessment and patients will have the option to continue     stimulation in an open-label continuation.   "
30911|NCT02881138|"     A tolerance, safety and pharmacokinetic ascending dose Phase I Study of RC48-ADC Administered     Intravenously to Subjects With HER2-Positive malignant in Advanced Malignant solid Tumors.   "
30912|NCT02881125|"     This phase I trial studies the side effects and best dose of nortriptyline hydrochloride when     given together with paclitaxel in treating patients with small cell carcinoma that has come     back. Nortriptyline hydrochloride, may help disrupt survival signals and cause cancer cell     death. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving nortriptyline hydrochloride and paclitaxel may work     better in treating patients with small cell carcinoma.   "
30913|NCT02881112|"     The study is an open-label, non-controlled study of the safety and effectiveness of     investigator determined Provant therapy in subjects with pain and/or edema from various pain     etiologies. Information collected in the study will be entered into a registry database.   "
30914|NCT02881099|"     Prospective observational study of Parkinson's disease with repeat clinical assessment and     biobanking of blood samples.   "
30915|NCT02881086|"     A phase IV study with the primary goal to optimize therapy of adult patients with acute     lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric     based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual disease     (MRD) based individualised and intensified therapy. Study will further evaluate the role of     asparaginase intensification, the extended use of rituximab and the use of nelarabine as     consolidation therapy in T-ALL in a phase III-part of the study. Furthermore two     randomisations will focus on the role of central nervous system (CNS) irradiation in     combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL     and the role of SCT in high-risk patients with molecular complete remission. Finally a new,     dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL     positive ALL.   "
30916|NCT02881073|"     The primary aim is to establish the effectiveness of plasma PlGF measurement in reducing     maternal morbidity (with assessment of perinatal safety in parallel) in women presenting with     suspected pre-eclampsia prior to 37 weeks' gestation.      The long term aim is to demonstrate that knowledge of PlGF measurement enables appropriate     stratification of the antenatal management of women presenting with suspected pre-eclampsia,     such that those at highest risk receive greater surveillance with a decrease in maternal     adverse outcomes, and those at lower risk can be managed without unnecessary admission and     other interventions, such that the results would influence international clinical practice in     antenatal patient healthcare   "
30917|NCT02881060|"     Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is     used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair     the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the     dual hormone treatment in preventing hypoglycaemia.      The purpose of this study is to determine, whether ethanol influences the glucose response to     subcutaneous glucagon during mild hypoglycaemia.      The investigators hypothesize that prior evening ethanol consumption does not reduce the     effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol     consumption.      The study aims:        1. To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to          restore plasma glucose after an episode of mild hypoglycemia.        2. To determine the late effects of ethanol on the counter-regulatory hormones and          hypoglycaemia awareness during mild hypoglycaemia      A double-blinded placebo-controlled study will be conducted. Participants will serve as their     own controls. Eligible participants will after an informed consent complete two study visits,     one with and one without ethanol consumption, in a random order. On each study visit,     participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with     or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100     mcg glucagon is administered. Two hours later a second bolus is administered.   "
30918|NCT02881047|"     Graft versus host disease (GVHD) is a common complication of allogeneic stem cell     transplant.Chronic GVHD is characterized by skin thickening and tightening. Advanced     sclerosis can lead to reduced range of motion and incapacitating joint contractures. Once     present, there are few therapeutic options. We will treat sclerosis and limb contractures     with an ablative fractional laser, a device FDA-approved for scar treatment. This approach     has successfully treated contracturesdue to burn scars.   "
30919|NCT02881034|"     Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin     than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure     the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal     function.   "
31069|NCT02879071|"     The time-frame and the follow-up elements after embolization of brain arteriovenous     malformations are not standardized. Therefore, few reliable follow-up data are available for     these patients. This study aims at collecting standardized long term data for these patients.   "
30920|NCT02881021|"     Introduction: Rotator cuff tendinopathy (RCTe) is the most frequent cause of shoulder pain,     resulting in considerable losses to society and public resources. Muscle imbalance and     inadequate sensorimotor control are deficits often associated with RCTe. Kinesiotaping (KT)     is widely used by clinicians for rehabilitation of RCTe. While previous studies have examined     the immediate effects of KT on shoulder injuries or the effects of KT as an isolated method     of treatment, no published study has addressed its mid- and long-term effects when combined     to a rehabilitation program for patients with RCTe. The primary objective of this randomised     controlled trial (RCT) will be to assess the efficacy of therapeutic KT, added to a     rehabilitation program, in reducing pain and disabilities in individuals with RCTe. Secondary     objectives will look at the effects of KT on the underlying factors involved in shoulder     control, such as muscular activity, acromiohumeral distance (AHD), and range of motion (ROM).      Methods and analysis: A single-blind RCT will be conducted. Fifty-two participants, randomly     allocated to one of two groups (KT or no-KT), will take part in a 6-week rehabilitation     program. The KT-group will receive KT added to the rehabilitation program, whereas the no-KT     group will receive only the rehabilitation program. Measurements will be taken at baseline,     week-3, week-6, week-12 and 6-month. Primary outcomes will be symptoms and functional     limitations assessed by the DASH questionnaire. Secondary outcomes will include shoulder ROM,     AHD at rest and at 60º of abduction, and muscle activation during arm elevation. The added     effects of KT will be assessed through a 2-way ANOVA for repeated measures.      Discussion: Investigations with a high level of evidence are needed to determine scientific     evidence-based concerning the efficacy of KT for the rehabilitation of individuals with RCTe.     This RCT will be the first to assess the effectiveness of KT added into a conventional RP for     patients with RCTe, addressing underlying factors that could explain the possible benefits of     this method, in a mid- and long-term. Results may contribute to build solid evidence on the     addition of KT in a physiotherapy intervention for this population.      Ethics and Dissemination: Ethics approval was obtained from the Ethics Committee of Quebec     Rehabilitation Institute (IRDPQ) of the CIUSS-CN. Results of this protocol will be     disseminated through international publications in peer-reviewed journals, in addition to     international conference presentations.   "
30921|NCT02881008|"     Randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in     patients with HBeAg negative chronic hepatitis B.   "
30922|NCT02880995|"     The first purpose of this study is to determine if dopamine synthesis capacity is     significantly lower in treatment non-responders from illness onset relative to treatment     responders. And the second purpose of this study is to determine the potential of [18     fluorine(F)]-DOPA to be used to predict treatment response to antipsychotic treatment in     first episode psychosis.   "
30923|NCT02880982|"     The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised     placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape     Town Metropolitan Municipality, Western Cape Province, Republic of South Africa.      The primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg     (10,000 IU) vitamin D3, administered for three years, reduces risk of acquisition of latent     tuberculosis infection (LTBI) in Cape Town primary schoolchildren.      Statistical analysis will be performed on an intention-to-treat basis to compare acquisition     of LTBI in intervention vs. control arms during three-year follow-up. The primary analysis     will be logistic regression with presence/absence of LTBI at follow-up as the outcome,     adjusted for a random effect of school of attendance.   "
30924|NCT02880969|"     End stage renal disease (ESRD) is a severe pathology, treated by dialysis on standby of graft     availability. Being under dialysis requires a recourse to pluri-weekly magazine of health     care system, impacting negatively patient's quality of life (QoL) and their entourage, at a     psychological, physical and social level.      Although further studies have assessed QoL in ESRD grafted children, a lack of information     exists concerning patients' QoL during dialysis before graft. In addition, some limits could     be listed, these studies have small samples, 50 patients at all, and only clinical     determinants are studied. A larger clinical research assessing children's QoL studying     individual and populational factors is necessary.      The aim of the study is to assess the influence of individual and populational determinants     on children's QoL with ESRD, treated by dialysis.      Material & Method An exhaustive inclusion of patient with ESRD treated by dialysis will be     realized at 20 French Pediatrics Dialysis Centers. Inclusion criteria are i) two genders, ii)     younger than 18 years old, iii) having an ESRD treated by dialysis, iv) attending at one of     the French Pediatrics Dialysis Centers for treatment between the 1st September 2012 and the     31th August 2014, v) being at their fourth to sixth week of dialysis. Patients will be     re-evaluated at 4th month and 7th month after first dialysis. Informed consent will be signed     by patient and their mainly caregiver.      Patient's QoL will be assessed using self-administered questionnaires Kidscreen 10 and VSP-A.     In addition coping (KidCope), anxiety (STAI-C, STAI-Y), personality / attachment (IPPA),     optimism (Y-LOT) measures and socio-demographic data will be collected. Self-administered     questionnaires will be used for assessing caregivers' Qol (SF36), anxiety (STAI-Y), coping     (BriefCope situational format), health care system satisfaction (Care quality scale) and     burden (Zarit Caregiver Burden Inventory). Child's QoL evaluated by caregivers will be     assessed using QUALIN, Kidscreen 10 parent and VSP-Ap. In addition, socio-demographic data,     urban environment and economic environment will be collected. Clinical data will be collected     by health professionals.      Results expected A sample of 136 children with ESRD is expected for identifying individual     and populational factors which could influence chronic dialysed children QoL, in order to     propose adjustments to optimize these patients quality of life.   "
30925|NCT02880956|"     This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early     Alzheimer's Disease.   "
30926|NCT02880943|"     This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum     tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients     with metastases to bone, without (Group A) or with (Group B) visceral metastases.   "
30927|NCT02880930|"     Vitamin D deficiency is highly prevalent in the UK. Research shows that vitamin D enhances     the immune system and may help protect against chest infections that can cause wheezing     illness or worsen asthma symptoms. The Department of Health recommends a dose of 10     micrograms of vitamin D/day to prevent severe vitamin D deficiency in children. However, many     studies have reported that this dose is not enough to raise plasma 25(OH)D concentration to     the levels most likely to prevent against worsening of asthma symptoms. Such studies suggest     that 25 micrograms of vitamin D/day. This dose is safe but its effects on vitamin D blood     levels have not yet been specifically tested in children with asthma/wheeze. This study is     designed to determine the optimal oral daily vitamin D supplementation dose to treat vitamin     D deficiency in children with asthma or preschool wheeze. Over the 6-month course of the     study, participants will meet with the study team four times in clinic or in their own home     and will be contacted by telephone five times. Children will be asked to give a drop of blood     via a fingerprick to test their vitamin D level and a sample of nasal epithelial lining fluid     for measurement of inflammatory markers on three separate occasions.   "
30964|NCT02880449|"     The aim of the project is pilot an intervention to promote physical activity (PA) among older     women.      Participants will be women aged ≥50 years attending an identified community centre situated     in a socioeconomically deprived area of Belfast. The intervention consists of education,     social support and information on local opportunities for physical activity (PA), based on     Social Practice Theory. A stepped wedge design shall be used. The intervention was developed     using findings from a literature review, systematic review and interviews with stakeholders.     Outcome measures are accelerometer data, self-reported PA, a mental health questionnaire and     qualitative interviews.   "
38253|NCT02784951|"     The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of     exsanguinating patients by physician-staffed emergency medical services in Norway, with focus     on prehospital transfusion complications and safety.   "
30928|NCT02880917|"     Chronic pain represents an important health problem responsible for decreases in quality of     life, and is associated with great negative impact in society and economy. In many cases, its     treatment does not reach therapeutic success causing health professionals and patients     dissatisfaction. Chronic pain is also associated with somatization, hopelessness and     catastrophizing thinking. These information processing includes sensorial, emotional and     cognitive-appraisal thinking, which manifests the working of neural networks at cortical and     sub-cortical levels. Attention and memory are a central aspect in the processing of pain     modulation. Like in addictions (e.g. smoking, alcohol), chronic pain may debut with     displacement in the focus of attention and alterations in the sensorial processing in the     incentive-motivation tests. Considering that other studies have indicated that experimental     and clinical pain is capable of modulating cognitive activities such as attention,memory and     expectation, in this study the investigators will test whether cognitive training, tDCS, or     the combination of both interventions decrease cognitive deficits associated with     Fibromyalgia   "
30929|NCT02880904|"     The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).   "
30930|NCT02880891|"     The microthreaded and platform switched implants could control the stress in the suitable     range. The splint would disturb the function. So it is necessary to know whether the splinted     single-unit crowns is fit for the adjacent multi-implants.      Outcome variables: Splinted single-unit crowns on one side implants and non-splinted     single-unit crowns on the other side Materials and method: 80-100 consecutive implants in at     least 20 patients would be included for implant- supported restorations in the posterior     maxilla or mandibular. All patients would be in general good health. For every patient, the     same posterior teeth had lost on both sides for more than 6 months. All patients were treated     by the same qualified surgeon.      Prosthetics procedure would be performed by an experienced prosthodontist. The two sides were     allocated to the test or the control group according to the predefined computer-generated     randomization table. Clinical evaluations and radiographic analysis were performed by an oral     and maxillofacial radiologist who was not aware of the type of Prosthetics technique that was     used.   "
30931|NCT02880878|"     This is a multicenter, randomized, adaptive clinical trial comparing standard medical     management to early (<24 hours) surgical hematoma evacuation using minimally invasive     parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial     intracerebral hemorrhage.   "
30932|NCT02880865|"     This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine     (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not     adversely affect immunogenicity or safety.   "
30933|NCT02880852|"     In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly     intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will     evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of     belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to     receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the     treatment of SLE. Subjects will be followed for 84 days after the administration of drug.   "
30934|NCT02880839|"     To compare the internal fixation results of three pedicle screw implantation methods and     investigated the accuracy and safety of digital navigation-assisted pedicle screw placement.   "
30935|NCT02880826|"     The tools to measure safety culture (CS) have recently become available. No study has focused     on the measure in France, apart from pilot studies. intensive services are particularly at     risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact     fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or     therapeutic strategies have report risk-benefit narrow. They may well be complicated by     EIG.Safety of care is a priority in the field of health in general, and especially in     intensive care. CS measure in this context seems particularly relevant.      The main objective is to describe the CS intensive care units in France. The study will     explore the development of the CS level for the units investigated.      This study will also describe the main features of RMM practiced in intensive care units in     France.   "
30936|NCT02880813|"     This pilot study will look at whether infusion of nutrients into the duodenum or into the     stomach will result in:        1. decrease in hunger and food intake        2. greater weight loss due to loss of body fat with reductions in waist and hip          circumferences        3. improvements in other weight-related health conditions such as diabetes, high blood          pressure, and high blood triglycerides. Inclusion criteria: 25-60 years old with a BMI          of ≥ 30≤55 kg/m2.      Subjects (16 individuals) will be in the study for 12 days and have a dobhoff tube placed at     the start of the study. Subjects will visit MCRU daily for 12 days where meals will be     provided, and where anthropometric measures, blood work during an oral mixed meal tolerance     test (study start and study end), and surveys will be completed. The dobhoff tube will remain     in place until the end of the study.   "
30937|NCT02880800|"     The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus     the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia)     on an as needed basis within a well defined fast track protocol that includes multimodal     analgesia for patients who are undergoing elective primary knee replacement surgery. The     investigators assumed that with the multimodal analgesia regimen without the use of IVPCA     will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids     related side effects and decreased length of stay in the hospital.   "
30938|NCT02880787|"     The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery     from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric     population.      Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:        -  the onset of clinical action of curare: suppression of the first response of train of          four monitoring (T1) of 95% initial value        -  the duration of clinical action of curare: recovery of the first response of train of          four monitoring (T1) to 25% initial value        -  recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of          four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)        -  complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.   "
30939|NCT02880774|"     Introduction: Temporomandibular joint dysfunction (TMD) is characterized for being a complex     and multifactorial pathology, where functional and pathological changes commit     temporomandibuar articulation, masticatory muscles, and other associated structures. In the     light of the whole complexity of the DTM noted the necessity of interdisciplinary treatment,     including physical therapy with the use of manual features, has been excelling. Objective:     The aim of this study is to evaluate the influence of mandibular nonspecific mobilization on     the mandibular movement and lateralidades, through the three-dimensional kinematics in     subjects with diagnosis of TMD, as well as analyze the behavior of pain, quality of life and     functionality of individuals with DTM pre, immediately after and 30 days of 12 treatment     sessions. Method: This is a clinical trial randomised, placebo-controlled and blind, designed     to study the effects of Mandibular Nonspecific Mobilization x Placebo (detuned ultrasound).     Individuals will be randomised controlled trials and allocated into two groups: Group A     (intervention) and Group B (placebo) and evaluated by the Research Diagnostic Criteria for     Temporomandibular joint Disorders (RDC/TMD) for diagnosis of TMD, numeric scale of Pain     (END), quality of life questionnaire (WHOQOL-BREF), Patient specific Functional Scale and     Kinematic Analysis Tridiemsnional. Statistical Analysis: Mandibular movement will be the     primary outcome and will be quantified by three-dimensional kinematic analysis. The pain,     Functionality and quality of life will be the secondary outcomes. Initially the distribution     of data will be checked by the Shapiro-Wilk test. In comparisons between the groups, if the     data present normal distribution will be used a repeated measures ANOVA to two factors, being     these: Group (intervention and placebo) and treatment (pre and post-intervention), with     Bonferrone correction. If the data do not show normal distribution, a logarithmic function is     used to correct striping. As level of significance will be used p < 0.05.   "
30940|NCT02880761|"     A cohort including more than 100 maintenance hemodialysis patients will be followed up     according to a certain Following-up System of Native Arteriovenous Fistulae (AVF)     prospectively. The assessment results of the Following-up System of AVF help the physicians     make decisions of AVF surgery and puncture methods. The results of this study would identify     the effect of the system on survival of AVF. Other 100 hemodialysis patients from other     centers will be treated by routine protocol and compared to the experiment goup.   "
30941|NCT02880748|"     Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number     of adenomas may be missed in patients with polyps found by previous colonoscopy. And water     exchange (WE) method may increase the detection of missed adenoma compared with traditional     air insufflation (AI) colonoscopy. The investigators aim to investigate whether water     exchange colonoscopy method, compared with air insufflation method, can improve the detection     of missed adenomas in patients undergoing selective polypectomy.   "
30942|NCT02880735|"     It has been suggested that patients with Myotonic Dystrophy type 1 have primary altered     ventilatory response to chemical stimuli and chronic hypoventilation is related not always to     muscle weakness. Also, it is known that Non Invasive Mechanical Ventilation can improve     ventilatory response to chemical stimuli, especially to hypercapnia.      This study evaluates the effect of Non Invasive Mechanical Ventilation on ventilatory     response in patients with Type 1 Myotonic Dystrophy, the ventilatory response to chemical     stimuli will be measured before and after mechanical ventilation in patients with myotonic     dystrophy type 1.   "
30943|NCT02880722|"     Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel     syndrome are essential in order to investigate natural disease course and potential treatment     options aimed at symptom improvement, since biological markers are currently unavailable.     Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires,     have considerable limitations. The Experience Sampling Method (ESM), an electronic     questioning method characterized by random and repeated, momentary assessments in the     subject's current state and environment, might overcome these limitations. Aim of this study     is to validate an IBS-specific electronic patient-reported outcome measure, based on the     Experience Sampling Method-principle, for symptom assessment in IBS.   "
30944|NCT02880709|"     Major weight loss and taste changes are well documented in patients with hematological cancer     during chemotherapy. It has previously been documented, that such patients have preferences     for much umami, a little sweet, sour and salt, and no bitter. The purpose of the study was to     convert these results into real diets. Patients participated in two sensory pilot studies     (n=10), where dishes were tested for preferences before and after chemotherapy. From these     results four dishes were selected and tested on 32 patients in 30 days in a cross-over     design. The diets resulted in a beneficial and statistical significant difference in weight     development (p= 0.0008), with 1.2 ± 1.9 kg (+2%) in the intervention period and -2.8 ± 5.2 kg     (-4%) in the control period. This difference persisted after sensitivity analysis (± 10%) p=     0.005. However, the nutritional intake was still low in both periods, and the treatment with     cytarabin turned out to be a major confounder as dosage was significantly higher in the     control period.   "
30945|NCT02880696|"     A key function of our brain is to identify temporal structures in the environment and use     them to form expectations. These expectations allow us to plan and organize our behavior     towards changes in the environment, and optimize the use of our attentional and motor     resources. They also allow us to establish harmonious social interactions, coordinating us     with our interlocutor during an exchange. Our ability to form temporal expectations seems to     emerge very early but the development of this process is unknown. We only know that a set of     basic skills, probably related to that ability, are present from birth. This suggests that     temporal processing capabilities emerge during the prenatal period, but this has not been     studied. The objective of this project is to study preterm infants brain's ability to process     the intervals between stimuli and to form expectations on that basis.   "
30946|NCT02880683|"     A single-center feasibility study in patients undergoing cardiac catheterization, to     investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.   "
30947|NCT02880670|"     This is an open-label, single-dose, study in healthy males. The primary objective is to     assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose     of radiolabeled BMS-986142 in healthy male subjects.   "
30948|NCT02880657|"     The objective of this study is to evaluate the influence of a 10 weeks SODB® supplementation     in physical condition improvements of healthy subjects, in comparison to a placebo.   "
30949|NCT02880644|"     In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and     safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in     United States and GALILEO study performed in Europe and Asia/Pacific.      With the project of Hermes Study, the first observational study conducted in France in     patients with CRVO and treated with aflibercept, we would like to evaluate in real life the     monitoring and the use of Aflibercept. The primary objective of this study will also be based     on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal     perfusion will be particularly evaluated by using ultra wide field angiography technology.   "
30952|NCT02880605|"     Coronary revascularization (CR) is increasing rapidly in China and varies significantly in     proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China. Recently,     National Center for Cardiovascular Disease organized experts to release Chinese version     appropriate use criteria(C-AUC) for coronary revascularization by RAND method aimed at     regulating indications of CR. The criteria is considered to contribute to clinical practices,     quality assessment and health insurance policy, however, the validation of C-AUC is unknown.      Thus the investigators study aims at assessing the validation of Chinese AUC by multi-center     prospective registry. The investigators will recruit 4000 patients undergoing elective     coronary angiography with positive outcome consecutively and collect baseline information.     Sequently, one-year follow up will be done to collect the prognose, including death,     rehospitalization, medicine, medical compliance and life quality etc. One hand, the     investigators will compare the outcomes between different therapies in the same indications     according to C-AUC to evaluate the validation of C-AUC. On the other hand, the investigators     will evaluate the rationality of CAD therapy in Beijing by C-AUC.   "
30953|NCT02880592|"     This is a multi-center, randomized controlled trial designed to evaluate the use of fresh     hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of     fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs     compared to SOC alone.   "
30954|NCT02880579|"     The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and     appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency     and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral     infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It     therefore remains a significant therapeutic challenge, especially for patients with     against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty     years of mechanical devices have been developed to remove, as quickly as possible, the cause     of intracranial arterial occlusion and allow restoration of blood flow before brain damage is     irreversible.      NTF The protocol is part of the evaluation process of our clinical practices recommended by     the National Health Authority (HAS), in the specific context of mechanical thrombectomy     performed in French centers of interventional neuroradiology working with neurovascular units     (A V).   "
30955|NCT02880566|"     Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp     blocks on hemodynamic stability and opioid consumption during and after craniotomy.   "
30956|NCT02880553|"     The World Health Organization International Classification of Functioning, Disability and     Health has shown that the environment can play a major role in patients' disability, and     hence in their quality of life. This study considers social dimensions of quality of life,     particularly family as well as social and professional networks.   "
30957|NCT02880540|"     Obesity represents one of the most important public health issues according to the World     Health Organization and it has reached epidemic proportions globally. The prevalence of     childhood obesity has rapidly increased over the past decade and is associated with multiple     co-morbid disease states . It is estimated that approximately 15.5% of children and     adolescents are obese with a body mass index of ≥95th percentile for age . This not only     poses health concerns for the patient, but also places increased demands on our healthcare     system that is already overwhelmed by burgeoning costs. Moreover, obese children and     adolescents who maintain excessive weight as adults are predisposed to cardiovascular disease     and premature death.      In carefully selected patients who have failed to lose weight by diet and exercise, bariatric     surgery provides an option to obtaining a healthy weight.      It is increasingly becoming an attractive option, with the number of adolescents undergoing     bariatric surgery in the United States tripling between 2000 and 2003.      Obese patients are often afflicted with multi-organ dysfunction and obstructive sleep apnea,     which presents unique challenges to the anesthesiologist managing their perioperative care .     Bariatric surgery in obese adolescents may be associated with significant postoperative pain.     Potent intravenous opioids such as fentanyl and morphine are at the mainstay of perioperative     pain management. Unfortunately, respiratory depression and airway obstruction can often occur     following administration of opioids in obese patients . This makes providing a safe analgesic     regimen difficult during the perioperative setting. As opioids can be associated with     respiratory depression and upper airway obstruction, surgeons and anesthesiologists alike     must reconcile the adequacy of pain control with the risk of respiratory complications after     surgery in obese adolescents.   "
30958|NCT02880527|"     Polymyositis and dermatomyositis are characterized by the association to a myopathic     syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an     important factor of morbidity and mortality in these patients. At present, studies that     evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly     recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has     been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria     of Bohan and Peter). However, previous works are old and retrospective; above all, they have     almost always been performed (90% of cases) from cases reported to the hospital, leading to     selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis     in the general population.      Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based     on the population of Normandy.   "
30959|NCT02880514|"     A prospective, randomized, single-blind, intra-patient controlled, multicenter study   "
30960|NCT02880501|"     Minimally invasive PFNA fixation for the treatment of intertrochanteric femoral fracture will     be used in 20 patients within 2 years to objectively validate the safety and effectiveness of     PFNA in the treatment of fracture of long tube-like bone.   "
30961|NCT02880488|"     The validation of a French questionnaire is very important to assess rigorously and     objectively the impact of the treatments of strabismus and amblyopia on children quality of     life.   "
30962|NCT02880475|"     This is an open-label, randomized, single-dose, parallel group study. The objectives of this     study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN)     prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese     patients with moderate to severe chronic non-malignant pain.   "
30963|NCT02880462|"     The goal of the study is to investigate whether adding different doses of sulforaphane will     benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.      This study will compare the sulforaphane with placebo. There is a thirty percent change (less     than half) of receiving the placebo. The purpose of including placebo is to judge if the     outcome is related to the study medication rather than other reasons.   "
32095|NCT02865668|"     The purpose of this study is to evaluate bioequivalence of the metformin component of the     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet     coadministered with canagliflozin in healthy fed and fasted participants.   "
30965|NCT02880436|"     Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol     levels and diabetes there are also acute factors potentially triggering acute coronary     events. The impact of various substances and air pollution are described.      Particulate matter, especially with small particle size (<2.5µm) has been shown to have a     positive correlation with myocardial infarctions. However, other studies failed to show this     correlation.      With respect to nitric oxydes the majority of published studies detected a significant     correlation with myocardial infarction, too, although a highly ranked publication failed to     show the same result. In addition data on the impact of sulfur dioxide and carbon monoxide     concentration on cardiac events is very heterogeneous.      Published data indicates additive effects of age and other epidemiological variables     suggesting the need of a multivariate analysis.      The rationale of the study is to test if the above mentioned air pollution factors have a     significant and independent impact on the incidence of myocardial infarctions   "
30966|NCT02880423|"     Based on the accumulated literature, salpingectomy may significantly reduce the risk for     ovarian cancer. If investigators can prove that there is no increase in surgical     complications and morbidity during salpingectomy in CS, compared to tubal ligation,     investigators can recommend for women who are interested in sterilization- salpingectomy     during cesarean section .   "
30967|NCT02880410|"     Multicenter, open-label, prospective designed study to characterize the performance of brain     laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in     combination with standard of care radiation therapy and temozolomide for the treatment of     newly diagnosed glioblastomas (GBM).   "
30969|NCT02880384|"     Study to compare the number of community-acquired pneumonia (CAP) pathogens detected using     current diagnostic tests to the number detected using the BioFire Diagnostics investigational     polymerase chain reaction (PCR) platform.   "
30970|NCT02880371|"     This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose     (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in     adult patients with selected advanced solid tumors (Part A), to assess the pharmacodynamic     effects of the combination and to describe the preliminary antitumor activity of the     combination in patients with advanced unresectable/metastatic melanoma (Part B), and to     estimate the efficacy of the combination in patients with PD-L1-positive NSCLC (Part C).   "
30971|NCT02880358|"     EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological,     observational, prospective and multicenter study. This study includes at first an exhaustive     recording of the cases on a geographic area at East of France, then the recorded patients are     followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL     study led by our team.      Main objective: To describe the characteristics of the patients affected by acute heart     failure and to identify prognostic factors, in particular related to care. More exactly :        -  To describe the sociodemographic, clinical, biological and therapeutic characteristics          of the patients presenting an acute heart failure during hospitalisation and living at          East of France ;        -  To study the short and medium-term morbi-mortality of these patients, and identify the          main factors determining the prognosis for survival ;        -  To evaluate the prognostic impact of the intra and extra-hospital care ;        -  To identify the evolution of the care's practices of the decompensated heart failure          since the EPICAL study (15 years) and their influence on the prognosis of the disease.      Secondary objective: to constitute a biological collection of serum, plasma and urine of     patients' sample presenting an acute heart failure.   "
30972|NCT02880345|"     This is a pilot study of a fixed dose of Pembrolizumab in combination with two different     regimens of hypofractionated radiation. It is designed to demonstrate the activity and safety     of the combination treatment in advanced urothelial cancer patients with prior exposure to     PD-1 inhibitors.   "
30973|NCT02880332|"     The primary scientific objective of the study entails examining whether altered endogenous     pain inhibition is present in children with functional abdominal pain (FAP) and irritable     bowel syndrome (IBS) compared with healthy controls (Part 1). A secondary objective implies     examining whether pediatric pain neuroscience education (PNE) is able to improve pain     catastrophizing, pain-related fear, pain intensity (including symptoms and indices of central     sensitization) and pain-related functional disability in children with FAP or IBS (Part 2).   "
30974|NCT02880319|"     This research study is studying a form of radiation therapy called stereotactic body     radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or     other bone   "
30975|NCT02880306|"     Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk     of developing malignancies, while studies examining the association between hepatocellular     carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of HCC     between participants with and without RA.   "
30976|NCT02880293|"     This study will test whether half matched donors with favorable KIR genes will reduce the     risk of cancer recurring after transplant.   "
30977|NCT02880280|"     Observe the therapeutic efficacy of human menopausal gonadotropin combining with human     chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.   "
30989|NCT02880111|"     Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different     according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study     is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a     Pseudomonas Aeruginosa chronic colonization.   "
30990|NCT02880098|"     Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is     increasing, yet normal values are still to be determined for the latest generation of tests,     such as High sensitivity cardiac troponin T test. This study is an observational study     designed to determine biological normal values of High sensitivity cardiac troponin T test     (troponin T -us) in newborns.   "
31169|NCT02877771|"     The goal of this study is to assess the functionality of an integrated predictive low glucose     suspend system designed to minimize the incidence and duration of hypoglycemia by suspending     insulin delivery if hypoglycemia is projected.   "
31170|NCT02877758|"     Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging     skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can reduce     the visible signs of cutaneous aging.   "
30978|NCT02880254|"     Kurbo is a health and fitness app that is targeted toward the pediatric population. It     utilizes games and activities to educate children about healthy eating, portion control/size     and exercise. It allows for food tracking by using servings of macronutrients and food groups     and sets goals for achieving a healthy BMI through modification of diet intake. In addition     to being created solely for children and adolescents, a unique feature of this app is an     option to speak with a personal health coach on a regular basis to obtain feedback, advice     and encouragement. Studies suggest that weight loss outcomes are best with more frequent     contact hours but most weight loss clinics, including ours, are not equipped to meet with     patients on a weekly basis or even monthly basis. The personal coaching aspect of Kurbo is     expected to improve outcomes by increasing user access to feedback and advice.      The purpose of this pilot study is to assess the feasibility, compliance with and effects of     a pediatric centered weight loss app on BMI z-scores in a group of children and adolescents     in a pediatric weight management program. The investigators will assess the impact of the app     as an adjunct to current weight management therapy, both with and without the personal health     coach (PHC) option.   "
30979|NCT02880241|"     The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed     activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced     Blood-Stage Malaria (IBSM) challenge model, and to determine the activity against P. vivax     malaria in patients, both over 14 and 28 days. Additional aims are to characterise the safety     of MMV390048 in patients. Patient safety will be monitored for up to 35 days post-dose     including pharmacokinetic assessments. The study will investigate descending single doses of     MMV390048 in response to results obtained in the first cohort/dose in each malaria sub-type.     The results of this trial will identify active, well-tolerated doses for investigation in     combination with a partner drug within a Phase IIb clinical trial.   "
30980|NCT02880228|"     This phase II trial studies how well pembrolizumab, lenalidomide, and dexamethasone work in     treating patients with newly diagnosed multiple myeloma that are eligible for stem cell     transplant. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of     cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving     pembrolizumab, lenalidomide, and dexamethasone may work better in treating patients with     multiple myeloma.   "
30981|NCT02880215|"     Although negatively biased attention has a central theoretical and empirical role in the     maintenance of depression, there are few behavioral treatments that successfully target and     improve this deficit. The current proposal builds upon prior work and aims to further develop     an attention bias modification intervention. The investigators propose to develop a highly     specific intervention that directly targets negative attention bias and the neurobiology that     supports it, using cutting-edge cognitive neuroscience to inform treatment development and     improve quality of life of patients whose psychopathology is maintained by negative attention     bias.   "
30982|NCT02880202|"     This is a pilot study to evaluate the impact of massage therapy in hospice patients.   "
30983|NCT02880189|"     This study is designed to investigate the impact of weight loss achieved with the IGB on NASH     with early fibrosis in a select cohort of patients with obesity preselected to have a high     pre-test probability of having NASH with early fibrosis based on MRE-Hepatogram. In addition,     this study will explore potential non-invasive imaging criteria for NASH and early fibrosis     using EUS-Elastography.   "
30984|NCT02880176|"     Radical cystectomy with urinary diversion is associated with substantial perioperative     morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional     decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the     risk of readmission, and adds substantially to health care costs. Protocols that emphasize     early and frequent ambulation after surgery decreases post-operative morbidity, but poor     patient adherence diminishes the effectiveness of these protocols, which are currently     implemented only during the hospital stay. Financial incentives overcome present bias and     offer a novel and practical approach to increasing ambulation during the post-operative     period in the hospital and also after discharge. This application proposes a pilot     randomized, controlled trial to estimate the effect size of financial incentives on achieving     a patient-specific daily step goal in the hospital and post-discharge for 1 month following     radical cystectomy. Secondary outcomes include step count, composite morbidity, and     functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the     Hospital of the University of Pennsylvania will be randomized to either control (education of     step goal with monitoring and daily feedback) or a gain financial incentive combined with a     lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips     will be used to measure step counts for all participants. This proposal will provide the     preliminary data needed to design future, larger trials that will test the effect of     financial incentives to increase ambulation on post operative complications, readmissions,     and functional decline.   "
30985|NCT02880163|"     The purpose of this study is to demonstrate safety, effectiveness and benefit‐risk profile of     ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to     trauma in patients where emergent laparotomy is required.   "
30986|NCT02880150|"     Climbing at high altitude and tolerating hypoxic environment require specific physiological     adaptations. Large intersubjects differences exist regarding the ability to adapt to high     altitude and hypoxia. The present study aims to characterise the physiological responses to     hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised     that elite climbers would show better physiological responses to hypoxia and more preserved     performances compared to sea level.   "
30987|NCT02880137|"     Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective     non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and     adult cardiac transplant recipients? Will perfusion deficits correlate with significant     coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary     Angiography (ICA), and identify diffuse small vessel disease more effectively than current     non-invasive techniques?   "
30988|NCT02880124|"     The purpose of this study is to compare the acute metabolic responses and time-trial     performance following the ingestion of carbohydrate solutions containing either maple syrup,     maple sap, corn syrup, a commercial sport drink or water.   "
30991|NCT02880085|"     The diagnostic gold standard to differentiate FAI (femural acetabular impingement) from other     muscular-tendinous pathologies is, actually, the injection of intra-articular anesthetic     (lidocaine), with a pre- and post- evaluation of pain scale.      If, after injection, the pain disappears, the pain is probably due to an articular problem     (FAI). This kind of differential diagnosis test has a sensibility of 100% and a specificity     of 81%.      C-terminal telopeptide of type II collagen (CTXII) as cartilage degradation index, could be a     marker, simply detectable, to assess the healthy of the cartilage status and could be     measured in serum and urine.   "
30992|NCT02880072|"     A phosphate supplement is part of the treatment of patients with the refeeding syndrome     (RFS). It is not known, if the generalized edema also affects the intestine to decrease     absorption. The aim was to investigate, if oral treatment is possible in mild to moderate     RFS. In a randomized crossover design 12 hospitalized head-neck cancer patients ingested four     oral solutions of phosphate in two-day periods. In a low-dose period the investigators     compared five mmol phosphate from either skimmed milk or Di-sodiumphosphate-di-hydrate and     potassium di-hydrogens-phosphate with black currant flavor (PBC), and in a high-dose period     20 mmol from either Addiphos® or the PBC-solution. P-phosphate was measured two and four     hours after the ingestion, the urinary excretion after four hours.      P-phosphate significantly increased after PBC in both the low- and high-dose and Addiphos®,     but not after skimmed milk. The increase was larger after Addiphos® than the PBC-solution.     There was no difference in the increase between the patients with low p-phosphate and those     with normal values, and no correlation between baseline p-phosphate and percent increase.     There was no group difference in the urinary excretion of phosphate. The investigators     conclude that phosphate can be readily absorbed after oral administration, but skimmed milk     can´t be recommend for this purpose.   "
30993|NCT02880059|"     Patients with intracerebral aneurysm will be screened for sleep apnea using out of center     polysomnography/polygraphy. Baseline blood pressure and medication will be assessed. Patients     will be followed for up to 5 years to examine the increase in aneurysm size, rupture rate and     changes in medication.   "
30994|NCT02880046|"     Purposes of this study are :        -  Characterization of polyfunctionality of anti-tumor T lymphocytes using in vitro          inhibition of PD-1/PDL-1 pathway        -  Study and comparison of polyfunctionality of anti-tumor T lymphocytes in cohorts of          patients with melanoma, lung cancer and renal carcinoma. This cancers are chosen because          of use of anti-PD-1 or anti-PDL-1 antibodies        -  Comparison of this technique with IFN-γ Elispot assay for detection and quantification          of anti-tumor T lymphocytes after in vitro blockade of PD-1/PDL-1 pathway.   "
30995|NCT02880033|"     Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models     to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC     can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative     stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron     metabolism and programmed cell death ...). The platelets are pivotal in the healing system     with large range of growth factors. A new therapeutic concept of conservative iron chelation     with deferiprone for neuroprotection is under development.      The action of deferiprone on the different mechanisms and notably the oxidative stress are to     obtain from a collection of PBMC and platelets from patient having Parkinson's disease and     Amyotrophic lateral sclerosis and healthy controls to study ex vivo.      PBMC and platelets will be stored for future analyses.   "
30996|NCT02880020|"     This randomized phase II trial studies how well nivolumab with or without ipilimumab works in     treating patients with gastrointestinal stromal tumor that has spread to other places in the     body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and     ipilimumab, interfere with the ability of tumor cells to grow and spread.   "
30997|NCT02880007|"     This prospective phase II trial study aims to optimize the increase in dose to the target     volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume     (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with     locally advanced cervical cancer.   "
30998|NCT02879994|"     This phase II trial studies how well pembrolizumab works in treating patients with epidermal     growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior     tyrosine kinase inhibitor therapy and has spread to other places in the body. Monoclonal     antibodies, such as pembrolizumab, may block growth in different ways by targeting certain     cells.   "
30999|NCT02879981|"     This pilot, multicentric and observational study will assess the of safety of     sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants     with acute bronchitis. Administration of treatment will be according to physician's     recommendation under local labeling.   "
31000|NCT02879968|"     Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and     Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma     antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.   "
31001|NCT02879955|"     To investigate the secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1),     after ingestion of glucose and fructose as separate monosaccharides or combined in the     disaccharides sucrose and isomaltulose and the effect of acarbose in gastric bypass operated     subjects and BMI-matched controls.   "
31002|NCT02879942|"     Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of     placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible     for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased     risk for cardiovascular events, both at short and long term. This justifies the need to     improve diagnostic tools to identify patients at risk for these complications. PE and IUGR     are multifactorial entities. Screening algorithms should thus include several parameters to     achieve high detection rates. Research has mainly focused in the analysis of biophysical and     biochemical parameters, and the study of the placenta itself has not been included in current     diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and     intrauterine growth restriction could be improved by the study of placental characteristics     in the first trimester of pregnancy.   "
32096|NCT02865655|"     To apply an existing diagnostic imaging test (saline infusion sonohysterography by     Hysteroscopic) to characterize the filling defect of a previous cervical cesarean delivery     scar in the nonpregnant uterus   "
31003|NCT02879929|"     Nasal symptoms are the main elements that lead to a therapeutic decision and allow for     evaluating treatment effects or natural evolution. Despite availability of several     questionnaires with good measurement qualities, no systematic assessment takes into account     the specific physical and psychosocial consequences of each of the six main nasal symptoms,     independently of the disease. The study proposed to measure these symptoms with the use of a     selfreport questionnaire and to test the validity of the questionnaire in a large     representative sample of patients attending outpatient rhinologic clinics.   "
31004|NCT02879916|"     This study describes the difference of analgesic effect of levobupivacaine 0.5% administered     through an interscalene nerve block with or without a stellate ganglion block. The length of     the analgesic effect is our primary outcome parameter. Half of the recruited patients will     receive a stellate ganglion block and half of the patients won't.   "
31005|NCT02879903|"     The aims of the present study will be identify 5 types of fimbrial subunit genotype strains     in smokers and nonsmokers with periodontitis, before and after periodontal therapy. Third two     periodontitis patients will be selected to these study, 16 nonsmokers and 16 smokers.     Clinical and microbiological parameters were evaluated at baseline and 3 months after     periodontal treatment: Plaque Index, Bleeding On Probe, Probing Depth, Gingival Recession and     Clinical Attachment Level. The prevalence of P. gingivalis and fimbrial subunit gene strains     will be determined by Polymerase Chain Reaction.   "
31006|NCT02879890|"     National cohort study aimed to investigate the impact of comorbidities (number and type of     comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).   "
31007|NCT02879877|"     This study is designed to evaluate the safety and tolerability of UCB7858 when given as     single ascending doses administered by intravenous or subcutaneous infusion in healthy     subjects.   "
31008|NCT02879864|"     Fatigue is a symptom most commonly associated with the diagnosis of cancer. Fatigue often     appears before the diagnosis of cancer, is increasing during treatment with chemotherapy and     persists for years after treatment in more than 35% of patients. Fatigue is the earliest and     most important symptom described by cancer patients. Its prevalence in cancer chemotherapy     patients is between 70 and 100%. Fatigue is more common to cancer patients and to the general     population or other types of patients. Typically described as a lack of energy associated     with mental disorders, fatigue related to cancer can be extremely debilitating. The causes     are many, mainly including the cancer itself, side effects due to treatment, sleeplessness     due to pain, anxiety or depression. The cancer-related fatigue has a negative and significant     direct impact on all aspects of the patient's quality of life, especially the physical,     social and behavioral. Despite the availability of certain treatments and the advanced     biomedical research, fatigue remains an inevitable consequence of cancer and its treatment.      The therapeutic use of natural light in medicine dates back to the late nineteenth century.     Its remarkable effect on the stimulation of the immune system and fight against infections     caused the development of the first therapy techniques (also called luxthérapie) awarded in     1903 by the Nobel Prize in medicine and physiology. Light plays a fundamental role in the     regulation of circadian rhythms and homeostatic. The mechanism of action passes through a     path non-visual involving melanopsin ganglion cells located in the retina. Activation of     the pineal gland (epiphysis) by melanopsin cells allows transduce information shadow and     light in melatonin synthesis from serotonin. Today, the effectiveness of the therapy is well     established for treating fatigue-related disorders such as chronic fatigue, seasonal     depression or seasonal or non-certain sleep disorders and in which the melatonin metabolism     is disturbed. Light therapy, by its mechanism of action, allows reprogramming of the     biological clock and improved synchronization of circadian rhythms.   "
31009|NCT02879851|"     The study aims at quantifying the registration error obtained in routine patients in     different parts of the prostate and for operators with different experience in order to     assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.      Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate     cancer will be prospectively offered to enter the study.      The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex,     midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the     prostate will be obtained at the end of the placement. As per our routine procedure, patients     will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic     fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed     by operators of varying experience using the Koelis system. The fiducials (visible on MR and     ultrasound images) will be used to quantify the registration error.   "
31010|NCT02879838|"     The purpose is to compare clinical, functional, professional and socio-economical     characteristics of patients with occupational asthma and work aggravated asthma.      Secondary purposes are:        -  to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide          and cytology of induced expectoration;        -  to estimate medical-social becoming of diagnosed work-related asthma after one year;        -  to establish a biobank of blood samples of individuals with work related asthma for          measurement of cytokines and search for genetic polymorphisms associated with asthma.   "
31011|NCT02879825|"     Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular     apparatus with a prevalence of 2-3% in the general population. This valvular disease is     generally considered as benign, but may at term evolve toward mitral valve regurgitation of     various severity and/or arrhythmia.      Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only     patients with significant mitral regurgitation will undergo subsequent examination (24-hour     external loop recording, exercise ECG, cardiac MRI) and a close follow-up.      External loop recording and exercise ECG have an interest in the identification of patients     presenting with arrhythmic complications, such as premature ventricular contractions, and in     the global evaluation of hemodynamic consequences of the mitral regurgitation.      More recently, detection of myocardial fibrosis among patients with MVP and severe     ventricular arrhythmia has been identified. Fibrosis could evolve independently of the     valvular regurgitation's severity and could be a substrate (myocardial scar) leading to     ventricular arrhythmia. However, no study has specifically characterized myocardial lesions     among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac     magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and     characterization, and echocardiography, particularly speckle-tracking imaging, identification     of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using     speckle-tracking strain) myocardial lesions.      Identification of patients with impaired deformation patterns, fibrosis or with premature     ventricular contractions may isolate a sub-group of patients with a higher risk of severe     ventricular arrhythmia for whom a closer follow-up could be justified.   "
32345|NCT02862483|"     The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower     urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a     randomized, double blinded, parallel design, active controlled, multi-center, phase 3     clinical trial   "
31012|NCT02879812|"     The purpose of the current study is to test a systems-level approach to disseminate a     multicomponent, multilevel intervention consisting of educational materials about     transplantation and the new kidney allocation system targeting dialysis facility Medical     Directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 end stage renal     disease Network regions across the United States will be randomized to receive intervention     materials. The overall goal of the study is to extend the influence of the national     allocation policy in reducing disparities in early steps in kidney transplant access.   "
31013|NCT02879799|"     In Alberta, nearly one in every twelve babies is born too soon (preterm). Preterm babies are     at greater risk for breathing and feeding problems, as well as infections, than babies born     on their due date (full term). As a result, parents must leave their preterm babies in the     hospital to fully develop and become healthy enough to take home. When it is time for     discharge, parents are often not ready to look after their baby because they may have limited     involvement in the care of their baby in hospital. In addition to the distress and costs to     parents of having a baby in hospital, health system costs are also increased the longer a     baby is in hospital. The purpose of this project is to test a new way to integrate parents     into the care of their baby through a program called Family Integrated Care (FICare). In     FICare, parents are educated and supported by nurses to provide care for their baby; nurses     and doctors still provide intravenous medications and medical procedures. FICare has been     tested in Ontario and shows promise as a better model of care for the small percentage of     babies born more than 8 weeks early, who have to spend a long time in hospital.      Now the investigators want to test FICare with the greater percentage of preterm babies who     are born 4 to 8 weeks early to see if parents are able to take their baby home sooner, and if     their babies are healthier. The investigators also want to know if FICare can reduce distress     for parents. The investigators propose to test FICare in Level II Neonatal Intensive Care     Units (NICUs) in Alberta by implementing FICare in half the Level II NICUs and comparing the     outcomes with the other Level II NICUs who do not use FICare. If FICare improves outcomes for     preterm babies and their parents, the investigators will implement it in all Level II NICUs.     In Alberta, the investigators want the best quality care for our most vulnerable babies and     their parents. This project is aligned with Alberta's Health Research and Innovation Strategy     priority of wellness at every age (child and maternal health), and with Alberta Health     Services' quality of care goals to increase efficiency, effectiveness, appropriateness, and     acceptability of health care services delivery.   "
31014|NCT02879786|"     The purpose is to determine the hierarchy of sensory afferents according to different forms     of dyslexia in children.      The secondary purpose is to determine sensitive and sufficiently specific posturographic     indexes for standard diagnosis of different types of dyslexia.   "
31015|NCT02879773|"     This study uses CT scans to assess airflow in the lung, the scan is quick, cheap and     painless. The information from the scan may help doctors tell which patients are suitable to     have surgery to cure early stage lung cancer. It may also help doctors tell which patients     would benefit from surgery for emphysema and diagnose types of lung disease. The     investigators will follow up patients who go through surgery to test how well the scan     predicts the function of the lung after surgery. The investigators will follow patients being     investigated for lung disease to test how accurate the scan is at the getting the diagnosis     right.   "
31016|NCT02879760|"     This is a Phase 1/2, multi-center, open-label, dose-escalation trial of Ad-MAGEA3 and     MG1-MAGEA3 in combination with pembrolizumab in patients with Non-Small Cell Lung Cancer who     have completed a first standard therapy with an platinum based chemotherapy.   "
31017|NCT02879747|"     The objective was to study whether normal growth velocity can be maintained with adapted GH     dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled     catch up growth (=difference to target height reached, less than - 0.6 SDS).   "
31018|NCT02879734|"     The purpose of this study is to compare function of the peritoneal dialysis catheter in two     groups of patients with and without prophylactic omentopexy that was performed during     laparoscopic insertion of peritoneal catheters.   "
31019|NCT02879721|"     Barrett`s esophagus (BE) is the major esophageal pre-neoplastic lesion in which dysplastic     transformations eventually can lead to cancer development. Today, the only way for early     detection of pre-neoplastic lesions is an endoscopic surveillance programme with tissue     sampling for histopathology, the latter being the only validated biomarker for esophageal     adenocarcinoma (EAC)-risk available. New biomarkers are warranted for better patient     selection before inclusion into BE surveillance programmes.      Epidemiologic studies have demonstrated suppressed numbers of cancer prevalence in cohorts     being under different medical treatment. In a British epidemiological study 2007 Sjöberg et     al noted a lower prevalence of EAC among patients treated with antihypertensive drugs     interfering with the renin-angiotensin system (RAS) such as AT1R-blockers and ACE-inhibitors.     The last decade this endocrine signalling system has been proven to be involved in     pathological conditions such as inflammation, wound-healing and even cancer, in several organ     systems.      Earlier reports from the investigators laboratory indicate the existence of a local RAS in     the esophageal wall musculature and in the squamous mucosa. In the investigators latest     explorative study, the investigators discovered the altered expression of classical RAS     components in BE with and without dysplasia (unpublished results).      By a possible alteration in RAS-related protein-expression in BE with increasing grade of     dysplasia towards EAC, the investigator may have a possible pathway leading to biomarkers     for cancer-development. Furthermore, the already well-known anti-hypertensive drugs     ACE-inhibitors and AT1R-blockers may interfere with the risk of malignancy in BE. The     investigators therefore wish to test, in an exploratory prospective randomized     placebo-controlled setting, whether RAS-related protein-expressions in BE are altered by the     addition of RAS-suppressant pharmaceuticals. In the same manner the investigators wish to see     if the expressions of well-known biomarkers for cancer and inflammation are altered.   "
31020|NCT02879708|"     In several low and middle-income countries, Social Accountability (SA) interventions have     been introduced as an innovative approach to governance, aiming to improve delivery of public     services. These interventions typically include information provision to citizens regarding     their rights/entitlements and local provider performance, and additionally, facilitation of     community engagement with providers and officials.      The state government of Uttar Pradesh (UP) and the Uttar Pradesh Health Systems Strengthening     Project (UPHSSP) have identified 12 districts where the social accountability initiative will     be introduced on a priority basis. This study focuses on interventions in 2 of these     districts (Sultanpur and Fatehpur), to study mechanisms through which information and     collective action lead to improved accountability and outcomes. Within the 2 districts, the     study is implemented as a cluster randomized evaluation with 120 villages randomized into 2     treatment arms and one control arm.      This study aims to: (a) measure the causal effect of SA interventions on key outcomes (health     status, quality of service); (b) test the effectiveness of social networks based strategies     to disseminate information for community engagement; and (c) study individuals' decisions to     participate in collective action efforts in the context of social networks and information     interventions. In addition to evaluating the impact of the SA interventions, the study aims     to generate new knowledge on relative strengths of information seeding strategies,     identifying those that maximize the spread of information through the village network, and     subsequently estimate peer effects on participation decisions.   "
31021|NCT02879695|"     This phase I trial studies the side effects and best dose of blinatumomab when given with     nivolumab alone or nivolumab and ipilimumab in treating patients with poor-risk CD19+     precursor B-lymphoblastic leukemia that has come back after a period of improvement or has     not responded to treatment. Monoclonal antibodies, such as blinatumomab, nivolumab and     ipilimumab, may interfere with the ability of tumor cells to grow and spread.   "
31023|NCT02879669|"     The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30     patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a     non-randomised safety phase and a randomised phase. The safety phase will consist of a     lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised     phase will not commence until the DSMB has deemed the safety lead-in data appropriate for     continuation. A total of 24 patients will be included in the randomised phase; 14 patients     will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will     receive pemetrexed/cisplatin alone. The trial's main objectives are determination of safety,     immune activation, clinical response and the correlation between clinical outcome and the     immunological data.   "
31024|NCT02879656|"     The present collaboration study on the treatment of distal radius fractures is aimed to:      (i) to compare the functional outcome in patient rated wrist evaluation (PRWE) score after     closed reduction and cast immobilization and operative treatment with volar locking plate in     the initial treatment of primarily unstable, non-reducible distal radius fractures in     patients over 65 years.      (ii) to compare the functional outcome in PRWE score after closed reduction and cast     immobilization and operative treatment with volar locking plate in the treatment distal     radius fractures with early instability during follow-up, ie. loss of reduction at one week     (5 to 10 days) in patients over 65 years.      (iii) to compare pain, disability, quality of life, grip strength and the number of     complications after conservative treatment and initial and postponed operative treatment of     distal radius fracture (iv) to assess the effect of pain catastrophizing score (PCS) on the     functional outcome of conservatively and operatively treated distal radius fracture   "
31025|NCT02879643|"     This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined     with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute     lymphoblastic leukemia (ALL).   "
31026|NCT02879630|"     Patients receiving acyclovir as standard of care will be enrolled into this study. The     currently recommended dosing strategy at our institution for obese patients is to receive     intravenous acyclovir dosed per an adjusted body weight [IBW + 0.4(TBW-IBW)]. They will have     blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total     time period of 12 hours. These patients will already be hospitalized for other reasons, and     will not be required to make additional trips to the hospital. A total of approximately 4-5     tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control     (non-obese) patients will be enrolled.   "
31027|NCT02879617|"     This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1     inhibitor durvalumab as first-line therapy in 50 patients with advanced NSCLC and ECOG     Performance Status 2 (PS2).   "
31028|NCT02879604|"     Significant cognitive impairment (executive functions, memory, attention) is common in     schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and     atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years,     alternative non-pharmacological therapeutics have been developed in schizophrenia. These     techniques called cognitive remediation specifically target cognitive deficits. The first     cognitive remediation available for patients was designed to stimulate new learning, or     relearning, of cognitive tasks, and thus to improve certain deficient domains. These     procedures were efficient in improving cognition as measured by neurocognitive tests but     their impact on functioning and daily life was weak. In a second time, compensatory     remediation has been developed. Compensatory approaches seek to make improvements in the     patient's functioning by avoiding areas of impairment and recruiting other intact cognitive     domains or by creating a supportive external environment. In recent meta-analysis     compensatory remediation has larger effect-size than classical cognitive remediation, with an     impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of     California) developed and tested a group-based, manualized, compensatory cognitive training     intervention.      Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily     transposable in community care. Our team translated this method into French. The     investigators planned a cost -utility study between CCT and treatment as usual in     schizophrenia patients with less than 10 years of evolution.   "
31029|NCT02879591|"     The objective of AlterEgo is the creation of an interactive cognitive architecture,     implementable in various artificial agents, allowing a continuous interaction with patients     suffering from social disorders, by virtue of changes in behavioural (robot-based) as well as     morphological (avatar-based) properties of that agent. The project includes research in     fundamental and clinical neurosciences, interaction modeling, development of new     computer-vision techniques and human-robot interfaces, as well as evaluation of the scenarios     with patients before, during, and after training sessions. At the end of the project, the     investigators will produce a new avatar-based clinical method able to enhance social     interaction of patients.      The first challenge of this project is to create an avatar alter ego of a patient. Based on     recent work in social robotics and neurosciences, the investigators hypothesize that if     patients face artificial agents morphologically and behaviourally similar to them, they will     increase their social interaction. The second challenge is to transform the morphology and     the behaviour of the similar artificial agent into that of a healthy and different agent. The     investigators assume that the smooth and continuous behavioural shift from similar/unhealthy     to complementary/healthy social behaviour will lead to a better social rehabilitation.     AlterEgo opens the door to a new generation of social artificial agents in service robotics.     AlterEgo is an interdisciplinary project at the interaction of Social Motor Neurosciences     (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision (DFKI), and     Psychiatry (CHU).      This project includes a set of experiments that started in april 2014 and will terminate in     september 2016 before undergoing a randomised clinical research.   "
31030|NCT02879578|"     Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of     NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and     adults with Tourette Syndrome (TS).   "
31070|NCT02879058|"     This study evaluates whether use of intraoperative ultrasound during laparoscopic or robotic     myomectomy impacts quality of life. Half of participants will undergo laparoscopic or robotic     myomectomy with use of the intraoperative ultrasound and half will undergo traditional     laparoscopic or robotic myomectomy.   "
31031|NCT02879565|"     Progress in resuscitation has increased the chances of survival after anoxic or traumatic     brain injury. More and more patients with severe cerebral damages are resuscitated but upon     awakening from coma, some patients remain in a state which cannot be qualified as conscious     and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative     state). This condition can be transitory and evolve towards recovery, or remain chronic and     lasting for years.      To improve the diagnosis of patients with disorders of consciousness, recent advances in     brain imaging have led to the development of new methods of detecting awareness. In the     absence of overt behavioral responses from these patients, imaging-based diagnostic methods     have been first used to assess whether some cerebral areas were preserved in UWS patients and     showed an activation of the primary sensory cortices in some UWS patients, whether it occurs     at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are     raised for clinicians before responding to such requests:        1. Is it technically possible to generalize neuroimaging protocols to all healthcare          institutions?        2. Is it ethically acceptable to propose neuroimaging protocols without an accurate          estimation of their psychological impact on families and caregivers?      The present study aims to understand and anticipate the technical and ethical issues related     to an evaluation of consciousness with functional neuroimaging. How the evaluation of     awareness in a patient affects the caregivers and family members will be investigated. By     using qualitative research hopes and expectations will be clarified through the experiences     of families, clinicians and nurses faced to this situation.      Will be included in this research professional caregivers and persons closely related to UWS     patients:        -  Family members or close circle visiting the patients on a regular basis        -  Referring clinicians        -  Nurses in charge of the patients' care      This prospective study uses qualitative, interview-based, research. Two key-moments are     explored in succession to examine the impact of a neuroimaging evaluation of consciousness in     institutionalized UWS patients:        -  interviews of professional caregivers and families about their hopes concerning the          evaluation of consciousness of UWS patients,        -  interviews of professional caregivers and families about the impact of evaluating          consciousness on their beliefs   "
31032|NCT02879552|"     Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with     favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the     efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.   "
31033|NCT02879539|"     Reducing power consumption in the cochlear implant is crucial to the development of future     smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be     more efficient in power consumption to the standard ACE strategy. However in order to develop     smaller sound processors, further battery life power savings are required. The aim of this     study is to evaluate three experimental sets of MP3000 parameter sets, compared against the     default ACE program. In the background for each of the four strategies, experimental noise     reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the     study, low stimulation rate ACE programs will also be evaluated against the default     stimulation rate.   "
31034|NCT02879526|"     The purpose of this study is to investigate efficacy and safety of Chidamide Combined With     Cyclophosphamide、Prednisone、Thalidomide in Treatment of Fragile Patients With     Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center     Study   "
31035|NCT02879513|"     This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP)     versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast     cancer and who were pathological partial response to DP as neoadjuvant chemotherapy.   "
31036|NCT02879500|"     Sugars have been singled out as one of the prime culprits in the dual epidemics of obesity     and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means     for displacing excess calories from free sugars in the diet. There is, however, a concern     that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes.     This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that     sugars in the diet not be replaced with ASBs but rather with healthy options such as water.     Whether ASBs more than water will contribute to obesity and diabetes remains unclear. To     address this important question, the investigators propose to conduct a series of systematic     review and meta-analyses of the totality of the evidence from randomized controlled trials     and prospective cohort studies to evaluate the effects of water and ASBs in the development     of overweight and obesity. The findings generated by this proposed knowledge synthesis will     help improve the health of consumers through informing evidence/base guidelines and improving     health outcomes by educating healthcare providers and patients, stimulating industry     innovations, and guiding future research design.   "
31037|NCT02879487|"     The aim of this study is to assess a major complication of total laparoscopic hysterectomy,     vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be     operated for laparoscopic hysterectomy will be randomized to two different techniques. The     colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the     second group. All of the operations will be preformed by the same surgical at a university     hospital. Vaginal dehiscence after surgery is the primary outcome measure.   "
31038|NCT02879474|"     State of the question Over the past decade, the incidence of melanoma (MM) has steadily     increased in France and in most developed countries. This increased incidence was concerned     mainly MM thin while the incidence of MM thick that represent the true killers, and     mortality from MM remained stable or increased slightly over the same period. These     epidemiological data and observations from everyday medical practice dermatologists suggest     the existence of different growth patterns within MM. Indeed, some MM progressing slowly     sometimes for decades before diagnosis but are thin at the time of resection. Conversely,     others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection     sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the     relative mortality in MM, as improved screening failed to influence to this day.      Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor     of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to     calculate the growth rate, an Australian team recently studied the growth rate in a     population of patients suffering from MM. In this population 1/3 of MM had a growth of more     than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals     (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The     European and Australian people are very different in particular regarding the prevention     policy, these results can not be extrapolated to the French population.The main objective is     to identify risk factors for FGMM in French propulation   "
31066|NCT02879110|"     In this proposed study, the investigators will evaluate the the efficacy, safety and related     mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will     recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or     placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety     assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are     to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral     problems and adaptive behaviors. Biological samples also will be collected, and stored to     research related mechanisms.   "
31039|NCT02879461|"     Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes     affecting the various vertebral segment structures, including: a joint zigoapofisária, yellow     ligament, the articular capsule and the intervertebral disk. These changes decrease the area     of the spinal canal and press the neural structures and may present clinically as the narrow     tunnel syndrome.      This presentation was first described by Verbiest associated with these anatomical changes     the clinical manifestations; corresponding to low back pain, pain in the legs that worsen     with the fact ambulate and improve with rest, this presentation called neurogenic     claudication .      The lumbar canal stenosis was divided into two main types; congenital and acquired . The     first is associated with a reduced size of the pedicles, which leads to a reduction of the     diameter of the spinal canal, common in patients achondroplasics . The acquired is considered     the most common type and is associated with aging, including all anatomical structures of the     lumbar segment .      With an aging population the number of symptomatic patients is increasing, although there is     no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical     approaches to the spine in patients over 60 years of age (7).      As described by Daffner et al a reduction in blood flow leads to production of inflammatory     mediators, which associated with anatomical changes previously described lead to the clinical     picture with lameness and pain in the lower limbs Treatment of these patients is beginning     with guidance on the disease, adequate pain control, physical therapy and exercise for     maintaining the activities of daily living. If these measures fail a surgical approach may be     necessary, especially in patients with exercise intolerance, difficulty walking and urinary     incontinence .      The surgical approach despite being widely studied in the literature prospective controlled     studies are rare, found series of case studies or retrospective studies, we try to evaluate     the effectiveness of surgery compared to rehabilitation in symptomatic patients in an attempt     to assess the impact of surgery associated with comparing therapy with isolated therapy in     these patients.   "
31040|NCT02879448|"     The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance     is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device     in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial     will be randomized to receive either the Amulet device or the WATCHMAN device and will be     followed for 5 years after device implant.   "
31041|NCT02879435|"     This research will explore the question of whether preincisional skin infiltration with     bupivacaine 0.25% decreases postoperative pain after Cesarean delivery.   "
31042|NCT02879422|"     Type 2 Diabetes (TD2) is the leading cause of new cases of preventable blindness in these     countries (and the gold-standard treatment, laser photocoagulation has proven to be effective     in preventing vision loss at the end stage of eye disease due to proliferative diabetic     retinopathy (PDR) that occurs in 3 to 6 % of the cases.Therefore, the ongoing search for     predictive factors of sight threatening stages of diabetic retinopathy has become more     important.      Previous studies that have examined candidate predictive factors for diabetic eye disease     have mostly focused on systemic risk factors leading to PDR. Among various clinical     parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration,     neuropathy and elevated triglycerides have been associated with PDR.      Some genetic factors may also account for the development of PDR and are prospectively     considered in this study .   "
31043|NCT02879409|"     There are numerous possible reasons why it could be speculated that HbA1c variability may     affect complication risk. Of interest are the concepts that both laboratory and clinic     evidence suggests that periods of sustained hyperglycemia are 'remembered' (metabolic     memory), this in turn is recognized to place patients at greater long-term risk of     complications. As such it can be speculated that the detrimental effect of variability in     HbA1c may be mediated via the same mechanism as 'metabolic memory' phenomenon.      Aims: To determine whether treatment to one of 2 threshold levels will result in one group of     type 2 diabetes patients having the same mean HbA1c but with differing HbA1c variability to     that of another and related to markers of oxidative stress, inflammation and microvascular     complications. To determine whether a difference in HbA1c variability between the 2 groups     will reflect in changes in small nerve fibers assessed with the sensitive method of corneal     confocal microscopy and cardiac autonomic function testing. To assess the reproducibility of     HbA1c measurement from a whole blood samples initially analyzed and then stored at -80C until     the end of the study (2-3 years), as well as storing an aliquot of haemolysate, for     reanalysis at the end of the study.      In one arm the investigators will intensify treatment in those with FPG>140mg/dl until their     FPG is <90mg/dl, using whatever treatment is clinically appropriate for them, and only     intensify it further if their FPG rises to >140mg/dl again. In the other group the     investigators will intensify if their FPG is >115 mg/dl until it is <=115 mg/dl and intensify     further if >115 mg/dl again. A total of 20 visits within a time frame of 2 and half years     will be performed. Visits procedures will include routine biochemistry, eGFR, lipids, fasting     glucose, insulin and full blood count, HbA1c, SHBG, hsCRP. EPIC and G-PAQ questionnaires will     be collected. Autonomic function testing using deep breathing heart rate variability, and a     sensitive measure of small fiber neuropathy using corneal confocal microscopy and a 24 hour     urine collection for urinary isoprostanes to measure oxidative stress will be performed, at     baseline, 12 and 24 months.   "
31044|NCT02879396|"     Saint Luke Home (SLH) is a home for low-income seniors who are ≥ 55 years and in need of     basic living help in Tucson, Arizona. Reports shows that emergency calls are made from SLH     (64 residents) around 60 times each year with emergency department (ED) visits and hospital     admissions that follow. In 2014, a total of 70 calls were made, and in 2015, 49 calls. The     Director, who is a nurse by training, and staff report that many of these calls are related     to medications and may be avoidable. Therefore, we believe we can make a difference and     decrease emergency calls, ED visits and hospitalizations that can be avoided with a program     to teach the elders and staff at SLH. The program is called Preventing Avoidable Admissions     Among Assisted Living Elders (PA4LE) and will consist of a 2-hour session every two weeks     including home or clinic visits (elder preference), educational sessions, and staff training.   "
31045|NCT02879383|"     The Revita System is intended to improve glycemic control in patients with Type 2 diabetes     who have preserved pancreatic beta cell function and whose diabetes is poorly controlled with     oral anti-diabetic medications. The purpose of this study is to demonstrate the efficacy and     safety of the Fractyl DMR Procedure using the Revita System compared to a sham procedure for     the treatment of uncontrolled type 2 diabetes.      Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham     treatment arm will cross over to receive the DMR treatment at 24 weeks with background     medications held constant from 24-48 weeks of follow up.   "
31046|NCT02879370|"     The technique the investigators propose to perform colorectal and colo-anal anastomosis in     patients underwent low and ultra-low anterior resection for rectal cancer could potentially     reduce the anastomotic leakage rate by better trans-anal introduction of the circular     stapler, elimination of the previous suture lines and dog ears, combined with direct     inspection of the anastomosis, easy performance of trans-anal air leak tests and eventually     direct repair of any small anastomotic defects. Another important point in cancer surgery is     the easily identification of the distal margin. In fact, this technique is simple to perform,     reproducible and safe in terms of complications.   "
31047|NCT02879357|"     The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious     Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and     allow control over their own decisions, relieve burdens of decision-making on family members,     and help patients achieve a state of peace as they approach the end of life.   "
31048|NCT02879344|"     ECMO (extra-corporeal membrane oxygenation) is a blood oxygenation technical and purification     of carbon dioxide by means of an extracorporeal circulation using a pump (identical to those     used in cardiac surgery) and a membrane permitting gas exchange. This technique is used for     almost 40 years in the acute respiratory distress syndrome (ARDS) but benefited from many     technology improvements over the past 10 years.      The circuit is now fully pre-heparin, not imposing obtaining activated partial thromboplastin     time (aPTT) high. Centrifugal pumps limit the risk of intravascular hemolysis. The     multi-perforated drainage cannula in place in femoral vein or jugular no longer need to     maintain hypervolaemia to ensure sufficient flow.      The membrane ensuring gas exchange is now polymethylpentene. This hollow fiber system ensures     the gas exchange.      In light of recent technical improvements, manufacturers indicate that the membranes can be     used for 3 weeks. However, after a few days of use, fibrinoplaquettaires microthrombi form at     the ECMO circuit, up from cannulas up to the oxygenator, decreasing membrane efficiency and     imposing more early changes of the circuit. This hypercoagulable state was revealed through     the study of classical plasma markers of coagulation. There is not so far from reliable     predictive marker of thrombus formation, indicating a need to change the circuit.      The production of microparticles (MPs) is a characteristic of cells subjected to an     activation or apoptosis. MPs are membrane Smaller fragments released into the extracellular     milieu after rupture of the asymmetry of the distribution of membrane phospholipids and     characterized by the presence of phosphatidylserine (PhtdSer) on their surface, as well as     various antigens expressed by their cells of origin. The PhtdSer is a pro-coagulating surface     on which are going to assemble the enzymes responsible for the formation of thrombin and     increases proportionally the TF activity ultimately leading to fibrin polymerization in the     vessels.      The vesiculation phenomenon exists in healthy subjects. In human pathology, many examples     emphasize the fundamental role of MP in clotting or thrombosis. The PM generating fault is     associated with bleeding disorders (Scott syndrome, dysvésiculation syndrome). Conversely,     high circulating levels of MP are found in many thrombotic diseases (myocardial infarction,     diabetes, antiphospholipid antibody syndrome, preeclampsia ...). Platelet and intense     monocyte endothelial activation, observed in sepsis and severe trauma, is accompanied by the     generation of procoagulant MP carriers of tissue factor (TF). These MP diffuse into the     vascular compartment pathogenic potential may exacerbate inflammatory and thrombotic     responses and play a leading role in triggering the DIC.      More recently, various studies have shown that the microparticles are not only activation     markers or injury, but also cellular elements having a true pathogenic role. Because they     contain or express on their surface various biological effector (adhesion molecules, tissue     factor, inflammatory mediators or apoptogenic, growth factor ...) the microparticles are able     to interact with their environment and modulate cellular very different way the properties of     target cells. And platelet or leukocyte microparticles could actively participate in the     thrombotic process by increasing adhesion of monocytes and endothelial cells, or by inducing     endothelial procoagulant response.   "
31049|NCT02879331|"     The study hypothesis is that patients with homogeneous emphysema behave differently compared     to heterogeneous emphysema with respect to exercise capacity. A better understanding of this     difference will allow the investigators to choose the best treatment for each type of     patient.      The main purpose of this study is to evaluate the change in exercise capacity measured by     cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with     coils (eLVR).      As a secondary purpose, the investigators want to perform an exploratory, randomized study to     compare the results of two different therapeutic approaches in a small sample of patients     with homogeneous emphysema.   "
31050|NCT02879318|"     The standard or usual treatment for this disease consists of two chemotherapy drugs     gemcitabine and nab-paclitaxel given together.   "
31051|NCT02879305|"     The purpose of this multi-center event-driven study in participants with anemia associated     with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.   "
31052|NCT02879292|"     Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal     medical emergencies.This retrospective study will review the files of all infants with HPS,     who were treated by open pyloromyotomy under spinal anesthesia in the Bnai Zion Medical     Center between the years 2006 to 2015.   "
31053|NCT02879279|"     Stroke is frequently associated with significant disability and impaired quality of life.     Persistent motor impairment is common with often incomplete recovery of motor function in     response to rehabilitation, mainly in the upper limbs. Robot-mediated therapy has been     proposed as a viable approach for the rehabilitation of the upper limb, but as the evidence     quality is low, more rigorous studies are needed. Previous studies have focused on the     effects of devices acting on a limited number of joints, often limiting the workspace on a     plane. This study aims to evaluate the efficacy of a multi-set of robotic and technological     devices for the rehabilitation of the upper limb in sub-acute stroke patients.   "
31054|NCT02879266|"     This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine     TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus     infection.   "
31055|NCT02879253|"     This study is part of the french research program ANR NEMRO MICROROBOTIC NASAL ENDOSCOPY BY     OPTICAL COHERENCE TOMOGRAPHY: IMPACT OF SMELL DEFICIENCY ON NEURODEGENERATIVE DISEASES.     Recent studies have shown a strong correlation between the decrease in olfactory faculties of     patients and the presence of neurodegenerative diseases.      This possible relationship has created a need to inspect in detail the area of the nasal     cavity that houses the olfactory function.      Thus, the purpose of NEMRO project is developing a robot to explore olfactory slots of     patients, with a view to extract images through non invasive imaging probe, and hoping to     identify early signs of degeneration the olfactory tissue. The robot developed will thus be     able to navigate in the nasal cavity of patients, and to break into the olfactory slots,     which will host the imaging phase.      The purpose of this study is therefore to collect data on the usual path of instruments     (endoscope, for example) in this area, and future potential pathway of the robot. This     collection made from Computed Tomography (CT) scans will define the clinical geometry of the     target area and provide precisely the dimensional constraints needed to build the NEMRO robot     .   "
31056|NCT02879240|"     Up to 50% of infants and young children cry during the administration of their inhaled     treatment for their asthma. This results in decreased lung deposition, and thus decreased     effectiveness of their inhaled treatment.      The objective of this study is to evaluate whether animated cartoons can increase the     cooperation of young children with asthma who are not cooperative during the delivery of     their ICS therapy through a pMDI/spacer.   "
31057|NCT02879227|"     Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.   "
31058|NCT02879214|"     The purpose of this study is to determine the feasibility of minimal invasive surgical     resection through simultaneously integrated dose escalation given concurrently with     chemotherapy for locally advanced squamous cell cervical cancer.   "
31059|NCT02879201|"     The investigators conducted a comparison trial between SLED and CRRT in critically ill     patients to evaluate the outcome for all cause mortality at 30 day . The secondary outcome     were recovery of renal function, complications during therapy and duration of     hospitalization.   "
31060|NCT02879188|"     The purpose of this study is to determine the impact of the timing of physical therapy (PT)     initiation on postoperative length of stay and the time to physical therapy clearance     following total knee replacement.   "
31061|NCT02879175|"     After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a     risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of     aneurysms.      Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by     ruptured intracranial aneurysms.   "
31062|NCT02879162|"     The standard or usual treatment for this disease may be chemotherapy or other types of     treatment to slow the spread of the disease and relieve some symptoms of this cancer.   "
31063|NCT02879149|"     The objective of this long-term study is to evaluate the long term effectiveness and safety     of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects     originally treated under Protocol BMTI-2006-01.      Subjects will be asked to consent and return to provide long-term follow-up data at or after     60 months (5 years) have elapsed since their original surgery as a subject in protocol     BMTI-2006-01.      STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained     and remains comparable to that of autologous bone graft over long-term subject follow-up.      REGULATORY PHASE: Post-approval study   "
31064|NCT02879136|"     Gait and balance problems are a significant source of disability in patients with Parkinson     disease. Physical therapy remains one of the main treatments. On the other hand some     medications, such as methyphenidate and atomoxetine, have been tried with promising results.     The outcomes in gait and balance in Parkinson disease after a combination of physical therapy     and the medications mentioned above have not been explored yet. The investigators want to     evaluate whether the addition of medication, either low dose of methylphenidate or     atomoxetine, to physical therapy will achieve improvement in gait and balance in Parkinson     disease more than physical therapy alone. The investigators propose a pilot, single center,     rater blind, prospective randomized trial. 2-arm-parallel group, intention-to-treat analysis.   "
31072|NCT02879032|"     Exercise treadmill test (ETT) is frequently done, inexpensive, relatively safe investigation     for diagnosis of ischemic heart disease and prediction of exercise capacity. Ischemic heart     disease is increasing by leaps and bounds all over the world even in the developing countries     like Bangladesh. The incidence rate of coronary artery disease (CAD) is not limited to male     gender as previously seen. As a cause of industrialization and increased life expectancy,     incidence of ischemic heart disease in females is escalating now in Bangladesh also. Though     ETT is a well accepted investigation to diagnose CAD, it has a high false positive and false     negative result if ST segment response alone is calculated for interpretation of the test.     Duke Treadmill Test and Simple Treadmill Test are valid and well known scores which can     predict coronary artery disease burden more efficiently than ST segment response alone.     Computer generated Cleveland clinic score is another valid treadmill score which has a     complex algorithm but effective way to predict 3 year and 5 year survivability. These three     scores are well tested on western population but to our best knowledge there is little or no     information regarding their predictability of CAD in Bangladesh. It's well known that ETT has     a high false positive result in female population, so applying the scores may render ETT more     efficient and abrogate unwanted risk of undergoing coronary angiography to diagnose CAD in     females. In this study the investigator will try to find out the accuracy of commonly applied     treadmill scores and ST segment response to diagnose CAD as well as accuracy of computer     generated Cleveland Clinic Score will be tested. Total 110 people including male and female     will be included according to inclusion and exclusion criteria and informed written consent     will be taken. The patients who have undergone ETT and coronary angiogram with in six months     for confirmation and identification of coronary artery disease in accordance with the     recommendation of ACC guideline for CAG will be selected . All available data will be     analyzed using SPSS. The accuracy of different scores will be calculated and compared with     each other. According to currently available data from studies in western population the     treadmill scores will have good predictability and will be efficient to abolish high false     positive result in female population in Bangladesh.   "
31073|NCT02879019|"     Whereas the efficacy of exercise interventions has been abundantly proven in male with     peripheral artery disease (PAD), it remains to be determined whether these interventions are     effective in women. The aim of this randomized controlled trial which will be performed with     34 PAD women will be to investigating the effects of 12 weeks of supervised walking on     functional capacity and cardiovascular function and regulation at rest and during exercise.   "
31074|NCT02879006|"     The purpose of this study is testing the use E-B-FAHF-2 Chinese herbal therapy in combination     with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults     who are allergic to foods be able to safely tolerate food allergens. Specifically in this     protocol, the food allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame,     and/or wheat. Omalizumab is considered an investigational drug for the treatment of food     allergies in children and adults. Investigational means it has not been approved by the Food     and Drug Administration (FDA) for use in the U.S. The researchers hope to learn whether the     addition of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained     unresponsiveness (which is the ability to consume a food allergen and pass an oral food     challenge after being off treatment for 3 months) as compared to placebo (i.e. subjects with     OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help adults and children be     able to safely ingest the foods they are allergic to.   "
31075|NCT02878993|"     This study aims to assess whether the electrical signal of the diaphragm (diaphragm     electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of     the lungs) can predict which infants will be successfully extubated (have the breathing tube     removed without needing it replaced.)   "
31076|NCT02878980|"     This clinical trial studies how well an exercise intervention works in reducing symptoms and     improving clinical outcomes in patients with ovarian cancer undergoing platinum-based     chemotherapy. Exercise may train the body to repair deoxyribonucleic acid (DNA) damage more     efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve     quality of life, increase survival, and decrease recurrence rates in patients with ovarian     cancer.   "
31077|NCT02878967|"     The time-frame and the follow-up elements after embolization of brain aneurysm are not     standardized. Therefore, few reliable follow-up data are available for these patients.      This study aims at collecting standardized long term data for these patients, in order to     assess the occurence of aneurysm recanalization and particularly those requiring another     intervention on the aneurysm.   "
31078|NCT02878954|"     This research project aims to investigate the gender-based difference in patients with     peripheral artery disease. To attend this, this study has two specific objectives:      Objective 1: To identify gender-specific barriers towards exercise and physical activity in     patients with peripheral artery disease (PAD).      Objective 2: To evaluate gender-specific differences in functional capacity and     cardiovascular function and regulation in patients with PAD at rest, during and following a     single session of maximal exercise.   "
31079|NCT02878941|"     The objective of this study is to obtain and compare bilateral elbow joint synovial fluid     from patients with unilateral intraarticular elbow fracture and a contralateral healthy     appearing elbow joint. The synovial fluid samples will undergo several forms of analysis for     metabolites and proteins. Matched-pair statistical analysis will be performed to determine     the metabolites and proteins that may play the greatest role in development of joint     contracture.   "
31080|NCT02878928|"     A prospective, multi-center, randomized, subject and outcome evaluator blind , parallel-group     study evaluating the effect of pharmacogenetic-guided versus standard of care treatment for     subjects diagnosed with depression and/or anxiety disorders.   "
31081|NCT02878915|"     Using ultrasound to guide vascular catheterism in children is highly recommended for central     venous access. It has been proven that central venous line is inserted faster, with fewer     attempts and complications. Its interest in central arterial line insertion is less obvious.     It seems to have benefits in adults, both for radial and femoral arterial insertion. But     there is no study assessing the interest of ultrasound guided arterial puncture in children,.   "
31094|NCT02878746|"     The investigators developed a real-time 2-axis mirror robot system as a simple add-on module     for conventional mirror therapy using a closed feedback mechanism, which allows for real-time     movement of the hemiplegic arm. The investigators conduct a case study for stroke patients     with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the     conventional mirror therapy group, the investigators prepared the tasks for fine motor     training.   "
31110|NCT02878538|"     The investigators propose to conduct a series of N of One (No1) single blinded clinical     trials to pilot the feasibility of using the iron-chelator deferiprone on Mild Cognitive     Impairment (MCI). Chelation therapy has previously been reported to slow the rate of     cognitive decline in Alzheimer's Disease (AD) by 50% in a single human randomized clinical     trial.   "
31111|NCT02878525|"     The purpose of this study is to study the effectiveness of laparoscopic internal gastric     banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy   "
31082|NCT02878902|"     Kidney failure is a major public health problem. REIN registry shows that 33% of patients     treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care     is associated with an increased risk of morbidity and mortality, with less access to off     dialysis center and kidney transplant. In addition, the emergency management has an impact on     the organization of health structures. The High Authority of Health in 2012 issued a care     pathway Guide aimed to report in this process of the multidisciplinary nature of the     management and coordination of principles and procedures for the Chronic Renal failure and     cooperation between professionals involved.  A function of coordinator of the Chronic Renal     Disease was set up in service since May 2013. Investigators propose to carry out a study to     value its impact on the start of the dialysis in emergency and hypothesize that this feature     innovative in France improves the patient pathway and thus reduce support emergency frequency     of ESRD.      The objective of this study is to show the improvement of the quality of care for terminally     chronic renal failure patients.      This is to evaluate an experiment aimed to facilitate a complex care path. If this experiment     is successful, it could form part of advanced practice.   "
31083|NCT02878889|"     A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen     Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.   "
31084|NCT02878876|"     This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects     of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein     proteins on the gastrointestinal symptoms for the health people who self-reported to be     lactose intolerant.   "
31085|NCT02878863|"     An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and     tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild     necroinflammatory activity on liver biopsy.   "
31086|NCT02878850|"     The purpose of this study is to learn more about how participants heal from acute spinal cord     injury.   "
31087|NCT02878837|"     This randomized, open clinical trial sought to compare the use of Midazolam and     Dexmedetomidine during surgery in patients under regional anesthesia.      The primary objective was to determine the superiority of either drug during the     intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.      Secondary objectives included the determination of superiority regarding the postoperative     period.      For that, patients were randomized into two groups and sedated with either Midazolam or     Dexmedetomidine.   "
31088|NCT02878824|"     Difference in autonomic nervous system processes across cultural and ethnic groups was     suggested and autonomic regulation differentiation may occur even at an early age. However,     the role of ethnicity and environment on regulation of response towards sensory stimulation     in children is not well understood yet. This research aims to compare the autonomic activity     at resting condition and toward a block of auditory stimulation between typically developing     children from different countries and living environments. There will be two phases in this     study. In Phase I, two groups of participants will be recruited: (a) 32 typically-developing     Chinese children living in Hong Kong, (HK group) and (b) 32 typically developing Filipino     children living in Hong Kong (Fil-HK group). In phase II, two groups of participants will be     recruited: (a) 32 typically-developing Filipino children who are living at Urban area (PH-U     group), and (b) 32 typically developing Filipino children who are living at Philippines-Rural     area (PH-R group). Participants will be composed of males and females ages 7-12 years old,     and without known history of developmental disabilities, medical history of cardiac or     pulmonary problem, medical history of diabetes, or having any sensory deficits. Recruited     participants will watch a silent movie, and listen to a block of sound. Autonomic activity     (heart rate variability and electrodermal activity) will be measured and recorded using Polar     H2 heart rate monitor and eSense skin response. Recordings will be screened for ectopic beats     of HRV or bursts of EDA. The HRV and EDA signals will be processed by using aHRV and the     eSense propriety software, respectively, and according to the standards of editing HRV and     EDA artefacts. Autonomic activity (LF, HF and EDA) at resting condition, and hypothesis     interaction between conditions (resting condition vs. auditory stimulation) and groups (HK     group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group) will be tested     with repeated measures of MANOVA. All significant levels will be set at p≤ 0.05. This study     will increase the understanding on the role of culture and environment in the regulation of     behaviour in auditory processing. The findings of this research may further shed light on the     evaluation and treatment planning for children across and within cultures.   "
31089|NCT02878811|"     The investigators will consecutively recruit 5000 patients hospitalized for heart failure     (HF) from 50 hospitals across China and follow them up for one year, describe treatment     patterns during hospitalization and the follow-ups, examine patients recovery trajectory     after HF, and identify targets for care quality improvement.   "
31090|NCT02878798|"     The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate     as a potential disease altering therapy for cryptogenic sensory peripheral neuropathy (CSPN).     Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do     not have an alternative cause for neuropathy will be potentially eligible. The co primary     outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN)     Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase     will last 24 months.   "
31091|NCT02878785|"     The purpose of this study is to find the best way to combine a new chemotherapy drug with one     that is already in use to treat AML. The new experimental drug is called talazoparib (also     known as BMN-673), and it is not approved by the Federal Drug Administration (FDA). The FDA     is allowing the use of talazoparib for the purposes of this study.      Decitabine is used to treat bone marrow diseases called myelodysplastic syndromes (MDS), as     well as off label for AML.      Lab work suggests that talazoparib will increase the effects of decitabine in leukemia cells.      Investigators hope that treating patients with decitabine and talazoparib together will be     more successful that treating patients with decitabine alone.      This study has two parts. The purpose of part one the study is to find out the best doses of     decitabine and talazoparib to use when they are given together to treat AML. The purpose of     part two is to see how well the drugs work together to treat AML.      All participants in the study will be treated with decitabine and talazoparib.      Part one of the study will include as few as two people and as many as 36 people to find the     best dose levels of the study drugs. Part one will begin enrolling first. Part two of the     study will not start until the Part one of the study is complete. Participants will be told     which part of the study they may be enrolled in. Part two of the study may include as few as     79 people and as many as 135 people. Part two includes three separate arms. Participants     enrolled in Part two of the study, will be assigned to one of the three arms below in order     to test the success rate of the study drug dose determined by Part one:        -  Arm A will enroll adult patients with AML who are thought not to be likely to tolerate          or respond to standard chemotherapy;        -  Arm B will enroll adult patients with AML that has not responded to previous treatment          or has come back after responding to previous treatment;        -  Arm C will enroll adult patients previously treated with a DNA methyltransferase          inhibitor (decitabine, azacitidine or guadecitabine).      This is a multi-center study. Up to 171 people may take part in this study globally.   "
31092|NCT02878772|"     Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke.     Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration.     Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the     outcomes of stroke. For this multi-center study, investigators recruited 60 patients with     anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but     lasted less than 48 hours. These patients, after randomly division into two groups, received     either standard management alone (controls) or standard management plus vinpocetine (30 mg     per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).   "
31129|NCT02878291|"     The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide     conjugate vaccine in healthy volunteers aged above 3 Months   "
31095|NCT02878733|"     The invesitgators utilized the Cerner HealthFacts database (a large HIPAA-compliant     clinical-administrative database maintained by Cerner Inc., USA) to identify a cohort of     6,249 adults that underwent on-pump cardiac surgery for valve and/or coronary artery     procedures between January 2001 and March 2013. Of these, the investigators selected 1136     patients who received 5% albumin on the day of or the day following cardiac surgery and     matched them (1:1) with 1136 patients who did not receive albumin. Characteristics on which     patients were matched included patient demographic, hospital and procedural characteristics,     baseline patient comorbidities including preoperative CKD and 26 other grouped conditions, as     well as acute severity of illness at admission to ICU.   "
31096|NCT02878720|"     Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus     nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present     study is to explore whether the combination of these two approaches might enhance their     positive effects on motor recovery. Safety and efficacy of this combination will be assessed     within a proof-of-principle, double-blinded, randomized, sham-controlled trial.     Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to     improve the response to the following robot-assisted therapy. Patients with both ischemic and     hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real     or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary     outcome, while changes in several quantitative indicators of motor performance extracted by     the robot as secondary outcomes.   "
31097|NCT02878707|"     Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In     brain tumor resection craniotomy, it is proven to be effective in improving postoperative     hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives     postoperative pain. In addition, many animal experiments show that DEX inhibits the     proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also     reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral     focal ischemic region (penumbra). However, the neuroprotective effects were never     investigated clinically in patients undergoing brain tumor resection surgery.   "
31098|NCT02878694|"     Interventional , multicenter , comparative study. One eye receiving the cells and the     contralateral eye as a negative control . If effectiveness following review of the primary     endpoint and the advice of an independent expert committee , the experimental treatment will     be offered to the patient to the contralateral eyelid.      Objective is to restore muscle function levator muscle of the upper eyelid by providing a     registry of autologous myoblasts from a non- clinically affected muscle .   "
31099|NCT02878681|"     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab     and aflibercept on systemic VEGF levels in DME patients in a detailed time course.   "
31100|NCT02878668|"     Post operative complication after hepatopancreatobiliary surgery is high as 30-50%，which is     the main reason for patient admitted to ICU. Several biomarkers have been shown to be useful     in the early diagnosis of sepsis and systemic bacterial infection. The purpose of this study     is to assess the predictive value of biomarkers for early complication after     hepatopancreatobiliary surgery and assess the effectiveness of anti-infectious therapy.   "
31101|NCT02878655|"     The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is     one of the main factors of poor prognosis, justifying the surgical management of neck     dissection as a reference treatment.      Under the influence of the American Hayes Martin, it was considered until the 1960s that     over the intervention was, the greater the chance of recovery was. But has since been     developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of     resection of lymph node tissue while retaining the main structures (muscles, nerves,     vessels), as opposed to the recess radical which is reserved for the invasive metastasis.      In addition to these notions, our job is to evaluate the quality of life of patients with     SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb     sector to support the approach which would be to stop the systematic inclusion of this     territory.   "
31102|NCT02878642|"     The main assumption is that the dolutegravir can get virologic suppression to suboptimal     adherence levels (between 80 and 95%, and after treatment interruptions) where other     molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).      While the investigators goal is not to compare molecules (study with one arm) in terms of     forgiveness, the results of this cohort in terms of forgiveness could be compared to other     cohorts available.   "
31103|NCT02878629|"     The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular     Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.   "
31104|NCT02878616|"     Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter     the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose     adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney     transplantation   "
31105|NCT02878603|"     The objective of this study is to evaluate long-term safety and efficacy of caplacizumab, to     evaluate safety and efficacy of repeated use of caplacizumab and to characterize long term     impact of TTP.   "
31106|NCT02878590|"     Prospective, non-randomized, open label study   "
31107|NCT02878577|"     This project, will combine the data collected from existing and innovative technologies: fMRI     scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the     BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic     resonance (the CoLI technology developed by Tel-Aviv University), and DTI imaging (imaging of     brain tracks). To do so, Sheba's Medical Center, Tel Hashomer, joined the project and is     responsible for recruiting patients from the Department of Neurosurgery and Department of     Rehabilitation and also is responsible for performing the needed tests.   "
31108|NCT02878564|"     The aim of this study is to assess the impact of Schistosoma mansoni infection and its     treatment on genital immunology and HIV susceptibility in Ugandan women.   "
31109|NCT02878551|"     The process of enhancing functional capacity of the individual in anticipation of an upcoming     stressor has been termed prehabilitation. In the present pilot trial, the impact of a     multimodal prehabilitation intervention composed of exercise, nutritional supplement and     psychological well-being begun in the preoperative period will be evaluated.   "
31112|NCT02878512|"     Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy     (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic     technique and is used for the fragmentation and removal of stones of size more than 20 to 30     mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge     because of the disease, surgical procedure, positioning, hypothermia,and the possibility of     fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard     for this surgery.The advent of new drugs has refined the technique of general anaesthesia.     However there are several issues related to prone position still to be addressed like     accidental extubation and difficult reintubation, nerve injuries and post operative     respiratory complications.      Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established     technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been     reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the     surgical site. This not only allows to limit the dose of the local anaesthetics, but also     limit motor and sympathetic blockade. Selective sympathetic block is associated with     respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our     current study. In the present study the investigators aimed to evaluate the efficacy of     segmental epidural for PCNL and compared it with standard technique i.e. GA.   "
31113|NCT02878499|"     The primary objective of this study is to undertake a longitudinal investigation of the     impact of sleep and circadian rhythm disturbances on cognitive and behavioural trajectories     in children with autism spectrum disorder (ASD) age 3-10 years old.      This innovative study will use objective quantifiable measures of sleep and circadian rhythms     in addition to subjective measures.      The investigators aim to assess the hypotheses that, in pre-pubertal children with ASD,        1. sleep disturbances are correlated with circadian rhythm disturbances;        2. both sleep and circadian rhythm disturbances are negatively correlated with cognitive          performance and positively correlated with behavioural disturbances;        3. sleep and circadian rhythm disturbances, most notably abnormal melatonin secretion,          impact the cognitive and behavioural development of children with ASD, depending on age          (prospective longitudinal analyses).   "
31114|NCT02878486|"     The purpose of this study is to determine whether the researchers can help people change the     amount of time they spend in sitting activities and whether this change might improve health     outcomes.   "
31115|NCT02878473|"     Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with     liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres due     to historically poor results. Two retrospective evaluations have shown a 5 year survival ~65%     in selected patients with an iCCA diagnosis at the pathology of the explanted liver. This     suggests that LT can be a curative treatment if applied selectively. This study will evaluate     the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients     who meet the strict selection criteria. Patients with advanced cirrhosis (not candidates for     resection) currently have no other curative treatment options. Participants will be allowed     bridging therapies prior to receiving transplant. Participants will be followed for 5 years     from the time of transplant with patient survival and disease recurrence as outcome measures.   "
31116|NCT02878460|"     The ORI (Reserve Oxygen Index) is an index measured through sensors SpO2 (oxygen saturation     by pulse oximetry - Radical-7 MASIMO) that evaluates noninvasively PaO2 (partial pressure of     oxygen). It represents the high PaO2 with values to 0 for a PaO2 <100 and up to 1 when the     PaO2 rises above 200 mmHg. Monitoring by the ORI, with setting an alarm for low values     (≥0,01) could help alert nurses when to decrease the FiO2 (inspired oxygen fraction). This     could reduce the FiO2 and avoid hyperoxia (i.e. daily PaO 2> 80 mmHg or 100). In the     literature, hyperoxia can be associated with prolonged mechanical ventilation, with increased     risk of atelectasis, or with excess mortality. And the use of high FiO2 led to a     over-consumption of oxygen and therefore to additional costs.      The purpose of this feasibility study is to evaluate the use of ORI can help to decrease     length of moderate hypoxemia (PaO2>100mmHg) during mechanical ventilation and oxygenotherapy,     in comparison with monitoring the SpO2 only.   "
31117|NCT02878447|"     The sequelae of tuberculosis are still the commonest causes of haemoptysis in the developing     world, where life-threatening haemoptysis remains a common and not infrequently fatal medical     emergency. Haemoptysis can be life-threatening either as a result of compromised gas exchange     or because of circulatory collapse secondary to acute blood loss. Haemodynamic and     ventilatory support, followed by bronchial artery embolisation (BAE) as a bridge to     potentially curative treatment such as lung resection, remains the standard of care. Often     patients do not qualify for surgical intervention and BAE is, at best, a temporary solution.     External beam radiotherapy (EBRT) may be an alternative, curative intervention in the     management of haemoptysis in patients with no alternative options. There is a paucity of     studies reporting the use of EBRT in patients without malignancy and with regards to specific     doses of EBRT. This pilot study aims to explore the potential of varying doses of EBRT in the     management of massive haemoptysis.   "
31118|NCT02878434|"     The researchers aim to record the incidence, treatment and long term follow up of fertility     preserving cancer treatment. Both the oncological and fertility outcome are recorded.      Study population: All patients with a cancer for whom a fertility preserving cancer treatment     is applied. The results of the study population are compared to young women undergoing     standard cancer treatment.   "
31119|NCT02878421|"     The purpose of this study is to assess the effects of electronic cigarettes-nicotine and     electronic cigarette-nicotine free on endothelial function as compared to traditional     cigarettes.      Participants will be randomized to one of three groups in a 1:1:1 fashion. The groups will     be:        1. Continue with tobacco cigarettes        2. Switch to electronic cigarettes containing nicotine plus flavor        3. Switch to electronic cigarettes containing flavor alone Treatment period will be 28 days   "
31130|NCT02878278|"     1. To compare the therapeutic effects, safety and the corresponding pharmacokinetics and          pharmacodynamics between two different method of drug administration: 10mg, daily and          30mg/d, twice every week, and find out the more effect way of Chidamide administration.        2. To examine whether Chidamide could activate EB virus, and whether the above two          different ways of administration are different in EB virus activation.   "
31120|NCT02878408|"     Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far     missing in psychiatry, and to design innovative treatment approaches based on the discovery     of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to     be significantly associated with neuro-inflammation, the project I-GIVE will combine     multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global     hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between     susceptibility to environmental factors (such as winter-spring births, infections,     urbanicity…) and genetic factors controlling immune responses.      Thus I-GIVE will allow identification of new biomarkers and their correlation with clinical     profiles and immuno-inflammatory/immuno-genetic markers, and description of     patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to     design innovative treatments and foster personalized psychiatry tailored to the needs of each     patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical     model for their ability to slow, stop, or even reverse the progression of the psychosis in     patients. I-GIVE project should thus lead to major results that will have strong impacts on     the scientific community, pharmaceutical industries and, in a longer term, on improvement of     patients suffering Bipolar Disorder or Schizophrenia and their family.   "
31121|NCT02878395|"     The purpose is to search for enterocyte-specific or non-specific molecular signature of     post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression     through number of mRNA copies transcribed for each gene) and in methylome.      Secondary objectives are to compare expression and methylation profiles according to:        -  treatment response        -  morphological (endoscopic and/or radiological) and clinical post-operating recurrence.   "
31122|NCT02878382|"     In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing     prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL),     is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).      Reduced response rates are observed in thicker skin lesions, which may be due to insufficient     PpIX accumulation within the target tissue.      To enhance PpIX production,several physical and chemical pretreatments have been suggested.     One of the chemical substances proposed to stimulate PpIX production is vitamin D because of     its ability of being a keratinocyte pro-differentiating hormone.      Based on in vitro and in animal model studies, we propose to study the potential impact of     patient vitamin D pre-treatment in AK response to MAL-PDT.   "
31123|NCT02878369|"     In order to identify the responding patients with vascular filling test, this research aims     to compare the performance of the increased flow in the femoral artery to the performance of     the blood pressure increase.      The reference measurement will increase cardiac output measured by ultrasound.   "
31124|NCT02878356|"     In the Swedish county councils and municipalities, Motivational Interviewing (MI) training     with different forms and content is taking place as part of the implementation of the method.     The study aims to evaluate to what extent the practitioners acquire and retain MI skills     trough the different training methods used by comparing them with a format that in previous     studies has shown to be required for the long-term acquisition of proficiency in MI; training     including supervision consisting of feedback based on monitoring of practice.   "
31125|NCT02878343|"     This study will evaluate the comparative effectiveness of behavioral economic financial     incentives and environmental strategies, separately and together, in achieving initial weight     loss and maintenance of weight loss, in obese employee populations. Our study contributes to     the Centers for Disease Control and Prevention's efforts to combat obesity but in particular     to the Centers for Disease Control's winnable battles (physical activity and obesity); the     National Center for Chronic Disease Prevention and Health Promotion's strategic priorities     around well-being, health equity, and evaluation and dissemination of environmental and     systems-wide solutions to address public health problems; and the National Center for Chronic     Disease Prevention and Health Promotion's domain around healthier work-site initiatives, the     Centers for Disease Control and Prevention's efforts to improve nutrition and physical     activity to prevent obesity, and reduction of cardiovascular disease risk. This study is a     4-arm randomized controlled trial in which 344 employees of the City of Philadelphia,     Independence Blue Cross, and South Eastern Pennsylvania Transportation Authority with initial     Body Mass Index of 30 will be randomized to receive one of the following: 1) Daily lottery     type incentives tied to achievement of weight loss goals (incentive arm); 2) individually     tailored environmental strategies around food intake and physical activity (environmental     arm); 3) a combination of incentives and environmental strategies (combined arm); or 4)     standard employee wellness benefits and weigh-ins every 6 months (control arm). Phase I of     the study (first 6 months) will focus on weight loss; Phase II (months 7-18) will focus on     continued weight loss or maintenance for those who choose to maintain weight loss as opposed     to continuing to try to lose weight; Phase III (months 19-24) will provide a period of     post-intervention follow-up to measure sustainability of effects.   "
31126|NCT02878330|"     The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and     antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29     and 35 weeks gestational age and entering their first RSV season.   "
31127|NCT02878317|"     The purpose of the present study is to investigate the association between the accumulation     of advanced glycation end-products (AGE) and adverse outcomes (e.g. death) in people     receiving haemodialysis and peritoneal dialysis based in Royal Derby Hospital, as well as the     impact of a dietetic intervention on AGE accumulation. AGE will be measured non-invasively in     the skin using a technique called skin autofluorescence (SAF).      The present study will be conducted in two parts:      Study 1: this will be a prospective study where participants will be followed-up for up to     five years. The research team will measure the accumulation of AGE in the skin using a quick     (less than five minutes) and painless technique called SAF. This involves placing the forearm     on a piece of equipment that shines a light on the skin and measures the amount of light that     is reflected back. Participants will be asked to complete nutritional and quality of life     questionnaires, measurements of weight, height, arm circumference and skinfold thickness     (i.e. anthropometry), simple eyesight tests and blood tests.      Study 2: participants will be randomly assigned either to a low AGE diet (intervention group)     or to a standard diet for people on dialysis (control group). Participants will be     followed-up for 2 years and will receive precise oral and written instructions on how to     comply with the diets. Blood and eyesight tests, SAF measurements, anthropometry and     nutritional and quality of life assessments will be conducted.      In Studies 1 and 2, approximately two teaspoons of blood will be collected to measure AGE     levels and do some additional blood tests to help us investigate the effects of AGEs on the     body. If the participants agree, the investigators will also store some of the blood for     future research.   "
31128|NCT02878304|"     The overall aim is to identify key determinants for recovery of hand function after stroke by     applying newly developed hand function measures together with MRI measurements of the     lesioned cerebral structures.   "
31133|NCT02878239|"     Static imaging has been commonly and clinically accepted to assess the severity of medial     knee osteoarthritis (KOA), especially the radiography. Gait analysis has been adopted to     evaluate the kinematic characteristics of the knees in patients with KOA. Most of the current     studies focus on the sagittal plane of the knee, but very few of them focus on the frontal or     horizontal plane. With the different severity of medial KOA, anatomical structures of the     knees will change and influence kinematics of the knees, such as osteophytes and deformity.     At present, there has been no study focusing on the relations between the imaging assessment     of the severity and quantitative kinematics of medial KOA. The aim of the study is to explore     the relationship between the imaging assessment based on the Kellgren-Lawrence Scores and in     vivo 3D knee kinematic characteristics in Chinese patients with medial KOA during walking     using a new portal gait system.   "
31134|NCT02878226|"     Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated     with an increased risk of maternal and perinatal morbidity and mortality, particularly in     developing countries compared to developed countries. UR occurs mainly as a consequence of     poorly managed labour   "
31135|NCT02878213|"     The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric     sensing compared with customary electrical isolation tests and Adenosine infusion at the end     of the procedure. Furthermore, safety, usability and clinical applicability of the system for     guided AF ablation will be confirmed.   "
31136|NCT02878200|"     Reactive treatment of household contacts of a confirmed malaria case has been shown to reduce     infection prevalence since the former as they are at an increased risk of infection. However,     implementing this on a programmatic scale poses significant pressure on the health system and     may not be sustainable without the active involvement of the recipient community. This study     investigates a novel approach to reducing residual malaria transmission that combines the     elements of active community involvement in reactive treatment of household contacts of a     clinical case reporting at a health facility. The investigators hypothesize that in areas of     low transmission (prevalence of infection ≤10%), most asymptomatic carriers are clustered     around clinical malaria cases in the same households. Also, targeting individuals sharing a     sleeping area with diagnosed malaria case will reduce parasite carriage in the community.     This is a cluster-randomized trial where villages in Central and Upper Baddibu, North Bank     East Region of The Gambia, are randomized to receive either reactive treatment of household     contacts following a confirmed case of malaria or standard care, i.e. treatment of index case     only. Formative research into community perception and reaction to self-administered     treatment will be used to generate, adapt and evaluate messages that encourage adherence and     compliance to treatment. This will be tested in the first year of the implementation, and     findings used to develop a final model of messages to be implemented in the second year of     the study. The primary outcome is the prevalence of malaria infection, determined by     molecular methods, in all age groups at the end of the second intervention year and the     incidence of clinical malaria during the transmission season.   "
31137|NCT02878187|"     Bleeding is the most significant cause of maternal death worldwide with more than half of     those occurring within the first day of delivery. About 10.5% (some estimate as high at     12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum     hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and     placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of     Cesarean hysterectomies done for abnormally adherent placentation   "
31138|NCT02878174|"     Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when     the internal jugular vein cannulation is attempted with US. This study is a clinical trial     that compares the success rates of both techniques and shows the non-inferiority of the     prelocation technique. However, during prelocation technique, rotated screen of the US is     used instead of original screen. The angle of rotation is determined by the degree of     rotation of US probe where an accelerometer is attached.   "
31139|NCT02878161|"     Rheumatoid arthritis (RA) is a chronic and disabling disease. tumor necrosis factor-a(TNF-a)     inhibitors have demonstrated an outstanding performance in relieving joint inflammation and     retarding bone erosion involved in RA. However, there is still about one-thirds of RA     patients had a poor response to TNF α inhibitors. The Investigators hope to discover     prediction protein with a domestic genetic background and finally establish prediction system     with Chinese characteristics.   "
31140|NCT02878148|"     Prospective single centre study aiming at validating a conditional imaging strategy for     diagnosis of suspected kidney stone.      Consecutive Emergency department patients referred to the medical imaging department for     exploration of a suspected acute uncomplicated renal colic will undergo the following     interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic     unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment     of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical     prediction score for symptomatic stone.      Patients will be followed up at 1 month to record the need for urologic intervention and its     type.      The performances of different conditional imaging strategy for the diagnosis of suspected     renal colic will be assessed retrospectively. The conditional strategies tested will be based     on the patient's stone score and BMI and targeted use of combined plain X-ray and     ultrasonography and/or unenhanced CT.      The reference diagnosis for renal colic will be made according to the finding of a ureteral     stone or indirect signs of urolithiasis at unenhanced CT.   "
31141|NCT02878135|"     intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's     often complain that its placement is one of the most uncomfortable parts of this procedure   "
31142|NCT02878122|"     Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking     surgery and chemotherapy based on taxol and carboplatine. Initial response is often good, but     most often a recurrence occurred in the first 18 months. Early recurrence signs     chemoresistance and palliative treatment. The study of predictive clinical or biological     factors is required to adapt therapeutic and develop new treatments.   "
31143|NCT02878109|"     This study is conducted to evaluate dynamic contrast-enhanced MRI to quantify the efficacy of     trans-arterial chemoembolization by comparing imaging results before and after treatment for     at least one hepatic tumor.   "
31144|NCT02878096|"     The primary objectives of the study are:        -  To determine the absolute bioavailability of SK-1404        -  To assess the mass balance recovery after a single oral (PO) dose of carbon-14          (14C)-SK-1404        -  To provide plasma, urine and faecal samples for metabolite profiling and structural          identification      The secondary objectives of the study are:        -  To determine the routes and rates of elimination of [14C]-SK-1404        -  To identify the chemical structure of each metabolite with an exposure (AUC) of more          than 10% of circulating total radioactivity        -  To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404        -  To further explore the PO PK of SK-1404        -  To provide additional safety and tolerability information for SK-1404   "
31145|NCT02878083|"     The main objective of this project is to demonstrate the feasability of an endomicroscopic     biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling     vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to     rhodamine.      This project should allow the development of a biomarker of therapeutic efficacy for     vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while     respecting manufacturing standards and Good manufacturing procedures.   "
31146|NCT02878070|"     My Care My Call (MCMC) is an innovative, peer-led telephone intervention designed to empower     adults with chronic spinal cord injury (SCI) in the self-management of their primary health     care needs to prevent secondary conditions. In a randomized controlled trial, participants     assigned to the MCMC intervention receive tapered calls from a Peer Health Coach (PHC) for     six months. PHCs are experienced, empathetic peer mentors living with SCI who act as     supporters, role models, and advisors, providing goal-setting support, motivation, education,     and resource referral to participants. Participants complete surveys at baseline, 2, 4, and     6-months, as well as qualitative exit phone interviews.      It is hypothesized that MCMC will: 1) Increase participants' self-advocacy in health care     interactions as reflected in increases in three domains of self-advocacy: assertiveness,     illness education, and potential for mindful non-adherence, 2) Increase participants'     self-efficacy for health care navigation, preference for involvement in, and satisfaction     with their primary care physician (PCP), and 3) Increase health related quality of life and     medical social support compared with those receiving usual care. Additional secondary     hypotheses state that the MCMC intervention will increase access to primary care and use of     preventive screening services compared with those receiving usual care.   "
31147|NCT02878057|"     The treatment of the patients with recurrent and metastatic breast cancer remains a major     problem. There is still a lack of effective targeted therapy for Her-2 negative breast     cancer.Based on the present researches on the anti-angiogenesis drugs in advanced breast     cancer, the investigators believe that it is necessary to further explore the efficacy and     safety of apatinib in advanced breast cancer.   "
31148|NCT02878044|"     The objective of this project is to evaluate a treatment decision aid for patients with low     risk thyroid cancer.   "
31149|NCT02878031|"     This one-arm safety intervention study is aimed at increasing access to treatment of     pneumonia by training CHWs, locally referred to as Community Oriented Resource Persons     (CORPs), to manage chest indrawing pneumonia using oral amoxicillin, conducting follow-ups     and recording their findings in case report forms. CORPs will also be involved in improving     care seeking for pneumonia in children by training them to conduct health education sessions     for men and women in their respective communities.      The primary objective is to assess if CORPs can safely and appropriately manage chest     indrawing pneumonia in 2-59 month old children, and refer children with danger signs. The     primary outcomes will be the proportion of children under five with chest indrawing pneumonia     who were managed appropriately by CORPs and the clinical treatment failure of chest indrawing     pneumonia. Secondary outcomes will include proportion of children with chest indrawing     followed up by CORPs on day 3 and caregiver adherence to treatment for CI, and clinical     relapse of pneumonia between day 7 to 14 among children whose signs of pneumonia disappeared     by day 6. Approximately 308 children 2-59 months of age with chest indrawing pneumonia would     be needed for this safety intervention study.   "
31150|NCT02878018|"     Henoch-Schonlein purpura nephritis(HSPN) is one of the most common secondary     glomerulonephritis in children.This is an important chronic disease endangering children's     health.The main drugs in clinic are glucocorticoid,immunosuppressants and     anticoagulation.Subject group concluded a series of prescriptions to treat children with     purpura nephritis:Qijishenkang lotion,Zhubai lotion,More Kidney lotion.Prospective cohort     study of clinical research methods are adopted.To develop clinical diagnosis and treatment     scheme which can be widely used to treat children with purpura nephritis (Heat Toxin Injuring     Collaterals Type,Damp Heat Injuring Collaterals Type,Qi Deficiency and Blood Stasis     Syndrome).   "
31151|NCT02878005|"     The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal     Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the     passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was     designed to assess the success rate of blind and fiberoptic endotracheal intubation using     iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.   "
31152|NCT02877992|"     The purpose of this project is to study the presence of expression differences - at RNA and     protein level - of different members of the tachykinin family and kisspeptin and their     receptors, between fertile women and infertile patients with different etiologies.   "
31153|NCT02877979|"     A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety     and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to     healthy HIV-negative women.   "
31154|NCT02877966|"     The primary objectives of this study are to evaluate the effects of an amino acid mixture     (Amixea) on the body composition as assessed by DXA, and on QMVC as assessed by strain gauge,     in advanced NSCLC patients, compared to placebo, after 10 weeks of treatment.      Secondary objectives are to evaluate the activity of Amixea on the degree of protein     synthesis, on the nutritional risk and status and quality of life in advanced NSCLC patients,     compared to placebo, after 10 weeks of treatment. In a small subsample, body composition will     be evaluated opportunistically from clinically available CT scans.      Adherence to, and patient satisfaction of treatment will be evaluated as exploratory     objectives of this study. Finally, the overall safety and product tolerability will be     evaluated.   "
31159|NCT02877901|"     It is a prospective randomized- placebo control crossover study to evaluate the effect of     long acting tolterodine (anticholinergic) in improving and treating nocturnal incontinence in     patient after radical cystectomy and orthotopic urinary diversion. patients will be randomly     allocated into two groups. one will receive the drug and the other will receive placebo.     continence status will be evaluated before and 4 weeks after treatment by the number of pads     used and the ICIQ-UI short form questionnaire. This is followed by two weeks of drug washout     then reevaluation of the continence status and each group will be crossed over and lastly     will be evaluated again.   "
31160|NCT02877888|"     Despite the availability of free health dental service in Sri Lanka, the prevalence and     severity of dental caries among 6year old school children stand at a very high level     according to the results of national oral health survey in 1983/84, 94/95 and 2002/2003.     Professional fluoride varnish application has become popular as variety of studies has found     that it is an efficient method in reducing dental caries. The simplicity of its application     makes it very suitable and practical for use in dental clinics and outreach dental services,     especially in young children.      Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium     fluoride varnish in prevention of dental caries in permanent incisors and molars in children     between 6 and 7 years in a suburban setting in Sri Lanka. This will be a double-blind,     randomized controlled trial. A sample of school children (6-7 years) will be randomized into     varnish and control groups. All the children will receive routine caries preventive measures     of oral hygiene instructions, dietary advice and professional cleaning. Children in varnish     group will receive fluoride varnish professionally applied after prophylaxis every 6 months.     Clinical examinations of all children will be performed at the beginning of the study and 1     year and 2 years later. All the caries at the dentinal level of both groups will be     stabilized with temporary restorations at the beginning. During this period, each school will     be visited four times at 6-month interval for recruitment, dental examinations, and fluoride     varnish applications. Recruited children will be randomly assigned to either a treatment (5%     NaF varnish) or a control group. Caries examinations will be conducted using the     International Caries Detection and Assessment System (ICDAS). The cost for the dental team's     school visits; cost involved in the treatment of dental caries throughout the course of the     study in both groups will be evaluated and compared at the end of the study. The sample size     is calculated as 160 each arm to detect 5% caries change with 80% power. Analysis The effect     of intervention will be measured by number of caries prevented. New caries in the usual care     and intervention group will be calculated after the completion of the study. The costs for     intervention will be estimated. The costs will be estimated for the dental material, time for     human resources and indirect costs.   "
31161|NCT02877875|"     The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual     school-based therapy on students' mental health and school-related outcomes, and test whether     changes in school outcomes are mediated by changes in student mental health.   "
31162|NCT02877862|"     This innovative project seeks to harness mobile phone technology as a means to take     preventive health care to a new level among ovarian cancer survivors. Using the Fogg     Behavioral Model, developed from the concept of persuasive technology, this study proposes to     develop the Mobile Application for Genetic Information on Cancer (mAGIC) intervention to     motivate ovarian cancer survivors to undergo genetic counseling. The overall study objective     is to develop and assess the feasibility and effectiveness of a theory-based intervention     aimed to encourage ovarian cancer survivors to receive genetic counseling   "
31163|NCT02877849|"     Due to the relapsing nature of alcoholism, excessive alcohol consumption represents a     significant cost to US society ($249 billion in 20101). About 64% of those entering treatment     will relapse within one year. New interventions targeting the underlying brain biomarkers of     relapse vulnerability hold significant promise in reducing this critical public health     problem. Using resting functional magnetic resonance imaging (fMRI) we have identified brain     biomarkers that support long-term abstinence and brain biomarkers that predict relapse. Our     data point to specific brain biomarkers that index higher relapse vulnerability at 11 weeks     of abstinence. Many individuals, however, have already relapsed by this time. It is unknown     whether these biomarkers can be identified earlier during the recovery period. We need to     investigate whether this biomarker of relapse vulnerability can be identified during earlier     stages of abstinence. Earlier identification of this biomarker will give valuable information     for timely targeted interventions (e.g. closer monitoring, longer stay in treatment program,     neuromodulation), increasing the chances of maintaining abstinence. The overall objective of     this study is to identify biomarkers of relapse during early abstinence (2-3 weeks of     abstinence). A secondary objective is to evaluate whether non-imaging measures such as     craving6 and executive function7 add value to prediction models. Findings from this proposal     will provide insight into the neurobiology of relapse vulnerability that will inform new     treatment strategies needed to improve treatment outcome.   "
31164|NCT02877836|"     The aim of this study is to evaluate the organization of the motor circuit in a group of     patients suffering from dystonia compared with a group of healthy controls. Deep Brain     stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor     circuit that has been applied to dystonia. The efficiency of this technique depends on the     relative preservation of the function and the structure of the motor network .      The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this     study might contribute to expand our understanding of the abnormalities in motor circuit     activation and the integrity of CNS structure underlying dystonia. This study might     contribute therefore to the refinement of Deep brain stimulation indications and techniques     in complex dystonia syndromes   "
31165|NCT02877823|"     Pediatric antipsychotic treatment is associated with significant obesity-related side     effects, including weight gain, increased blood sugar, abnormal cholesterol, and risk of new     onset diabetes. Antipsychotic-induced weight gain is most prominent over the first 6 months     of treatment. In this study, youths who are started on antipsychotic medication are     identified for a health intervention to minimize antipsychotic-induced weight gain and also     have collateral health benefits for the child's parent. Children are identified through a     Medicaid medication authorization program which provides a complete list of eligible youth.     Youth-parent pairs will be enrolled. All youth and their parents enrolled in this study are     offered healthy lifestyle education with simple targets to reduce risk of     antipsychotic-induced weight gain (e.g. reduce sugar sweetened beverage intake, engage in 1     hour of daily physical activity). Half of families will also receive 1) home delivery of     bottled water, 2) provision of a child pedometer, and 3) health coaching/support from a     telephone-delivered, parent peer program (Family Navigator). Home water delivery has been     demonstrated to dramatically reduce sugar sweetened beverage intake in general pediatric     studies. Child pedometers will be used to encourage parent monitoring of child physical     activity. Parent peer support will be provided through a Family Navigator, who is a parent     with lived experience raising a child with special mental health needs. Family Navigators     address practical barriers to lifestyle changes for low income families (e.g. identify safe     environment for physical activity, support access to food pantries) and provide emotional     support for parents dealing with competing child health priorities (emotional stability,     obesity health concerns). Family Navigator contact is exclusively by phone, and all study     visits will occur in the home. The Family Navigators are supervised by a child mental health     expert team, with an on-call licensed clinician available to address any after hours/weekend     urgent concerns. The impact of this intervention will be studied on both child and parent     health outcomes (weight, blood pressure, sugar sweetened beverage consumption), child     physical activity, as well as parent behaviors associated with child healthy lifestyle     changes (e.g. modeling healthy behaviors, monitoring child activity). Assessment of the     impact of this healthy lifestyle intervention on other obesity related outcomes that are     monitored through blood work (e.g. blood sugar, cholesterol). These labs are obtained by     community prescribers as part of standard of care and submitted to Medicaid as required for     ongoing approval. No blood work will be done in this study protocol. Child lab results will     be requested from the Medicaid pre-authorization program.   "
31171|NCT02877745|"     In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary     artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative     atrial fibrillation and complications will be assessed. The primary objective is to     determine, whether SDB patients have a higher rate of Major Adverse Cardiac and     Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.   "
31172|NCT02877732|"     This is a prospective multi-center cohort feasibility and exploratory study.   "
31173|NCT02877719|"     The aim of this study is to explore the impacts of poverty and income disparity on the     psychological well-being of Hong Kong Chinese children.   "
31174|NCT02877706|"     CARMEN is a clinical registry of all incident adult Immune thrombocytopenia (ITP) patients in     the Midi-Pyrenees region (South of France). It is aimed at describing ITP clinical features,     assessing several second-line treatments (SLTs) benefit-to-risk balance and adherence to     guidelines for ITP management.   "
31175|NCT02877693|"     to assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in     patients undergoing an elective thoracic MRI scan.   "
31176|NCT02877680|"     Type 1 diabetes (T1D) management is particularly challenging during adolescence as     responsibility for management begins to shift from parents to youth, and positive family     teamwork is critical to achieving optimal diabetes outcomes. Existing behavioral family     interventions for T1D are beneficial but have limited potential for translation to clinical     practice, and universal preventive approaches designed to explicitly promote existing T1D     management strengths are needed. Ultimately, the goal of this line of research is to validate     brief, convenient, and helpful tools that families of all adolescents with T1D can use to     strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.   "
31177|NCT02877667|"     Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.   "
31178|NCT02877654|"     Increased intestinal permeability is one of the main pathophysiological mechanisms involved     in irritable bowel syndrome. The expression of some intestinal tight junction proteins is     decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased     intestinal permeability. Currently, no test used in clinical practice could assess intestinal     permeability.      We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.   "
31179|NCT02877641|"     This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation     works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic     obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the     risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient     patients with COPD.   "
31180|NCT02877628|"     Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric     study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to     clinicians or patients during the study.   "
31181|NCT02877615|"     The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing     functional recovery after an ischemic stroke.   "
31182|NCT02877602|"     This is a qualitative study to determine which factors affect the patient experience of     having a liver MRI, what information patients would like to receive after their MRI, and how     patients would like this information communicated to them.   "
31183|NCT02877589|"     Immunosuppression induced by cancer treatment increases the risk of hepatitis B virus (HBV)     and hepatitis C virus (HCV) reactivations. These viral reactivations may be asymptomatic but     can cause fulminant hepatitis and death. More, they impact the treatment of cancer by     chemotherapy delays or stops. They can occur during cancer treatment but also after stopping,     at the immunological rebound. This risk persists for at least 6 months after cessation.      The key to the prevention, and the first step, is serological testing. It is also the main     problem because international recommendations diverge. Hepatologists and infectious disease     specialists recommend routine screening HBV of all candidates for immunosuppressive therapy.     These recommendations are more implemented by hematologists, given the frequency of HBV     reactivation associated to haematological malignancies. Clinical oncology societies     guidelines suggest a selective screening in case of risk factors of hepatitis B or in     patients with a strong immunosuppression (such as anti-CD20 based treatment, stem cell     transplantation or lymphoma treatment).      The consequence of these differences is a sub-screening by oncologists and the persistence of     fatal cases. Screening before cytotoxic chemotherapy for solid tumors in countries with low     prevalence of HBV and HCV virus is questionable. Selective screening of patients at risk HBV     and HCV can be assessed.   "
31184|NCT02877576|"     The purpose is to evaluate specific capacities of face detection of individual neurons by     comparison with their capacity of object detection in medial temporal lobe and ventral     temporal cortex in epileptic patients.      Secondary purpose is to evaluate specific capacities of detection of known faces of     individual neurons by comparison with their capacity of detection of unknown faces in medial     temporal lobe and ventral temporal cortex in epileptic patients.   "
31282|NCT02876302|"     This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast     Cancer (IBC).      The Following drugs will be use in combination with Ruxolinitinib.        -  Paclitaxel (also called Taxol)        -  Doxorubicin also called Adriamycin        -  Cyclophosphamide, also called Cytoxan   "
31185|NCT02877563|"     This study represents an important step to validate the use of contrast-enhanced ultrasound     (CEU) as a clinical research tool that can be used as a biologic readout of new therapies for     Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing impact     of revascularization. The primary aim is to establish that CEU limb perfusion imaging can be     used to accurately assess therapeutic improvements in tissue perfusion that are linked to     symptom improvement.   "
31211|NCT02877225|"     The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of     ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.   "
31272|NCT02876432|"     Activation of the sympathetic nervous system attenuates inflammation via catecholamines,     recent advances in electroacupuncture allow activating critical neuronal networks with the     release of catecholamines the aim of this research was to evaluate de effect of     electroacupuncture in the activation of sympathetic nervous system and the control of low     back pain in athletes   "
31186|NCT02877550|"     Follicular lymphoma (FL) is an indolent yet incurable lymphoma characterized by initial     responses to standard therapies, invariably followed by shorter disease free intervals.     Obinutuzumab, a novel type II, anti-CD20 monoclonal antibody has been approved in combination     with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia     (CLL) and in combination with bendamustine followed by obinutuzumab alone for FL who did not     respond to, or who progressed during or after treatment with rituximab or a     rituximab-containing regimen, or in relapse after such treatment. Additionally, venetoclax, a     small molecule Bcl-2 inhibitor, showed single agent activity in relapsed/refractory (R/R) CLL     and other B-cell lymphomas, including R/R FL. Preclinical evidence suggests a synergism of     the two drugs in vitro as well as in different lymphoma in vivo models. Based on single agent     clinical activity and on the preclinical data of the combination of both drugs and aiming to     develop a new chemotherapy-free combination regimen, this trial plans to evaluate the     combination of obinutuzumab and venetoclax in previously untreated FL patients in need of     systemic therapy. This phase I study will provide information on the safety and tolerability     together with evidence of preliminary antitumor activity. Combination treatment consists of a     6 cycles of 28 days each. The combination therapy is followed by a 2 years maintenance with     obinutuzumab. Dosing of obinutuzumab is as per Swissmedic approval in FL.Venetoclax will be     administered in different dose levels according to the trial design.   "
31187|NCT02877537|"     The purpose is to characterize the change of respiratory admittance induced by salbutamol     inhalation in children and young adults. A variation threshold will be fixed to distinguish     asthmatic and healthy subjects.      This project could allow a better identification of asthmatic individuals needing a     treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments     administered in individuals with respiratory but not asthmatic symptoms, a better     comprehension of bronchial hyperreactivity and its role in asthmatic disease.   "
31188|NCT02877524|"     The clinical course of chronic obstructive pulmonary disease (COPD) is associated with     recurrent episodes of exacerbation that results in respiratory failure. The treatment of     respiratory failure is supportive and involves inhalation bronchodilators along with systemic     steroids. In few cases the management of acute respiratory failure requires positive pressure     ventilation (non-invasive or invasive). The use of NIV in acute exacerbation of COPD has     resulted in significant reduction in morbidity and mortality. Although pressure support     ventilation (PSV) allows the patient to influence the breathing pattern, ventilator-cycling     criteria may worsen the patient-ventilator interaction, and severe asynchronies occur in up     to 43% of patients undergoing NIV for ARF. Adaptive support ventilation (ASV) is a newer mode     of ventilation that incorporates feedback mechanisms and thus provides a stable minute     ventilation. We hypothesize that the use of ASV as a mode during ventilation using NIV in     patients with acute exacerbation of COPD may result in reducing the duration of ventilatory     support, need for intubation, and duration of intensive care unit (ICU) and hospital length     of stay, when compared with PSV mode of NIV ventilation.   "
31189|NCT02877511|"     To assess the safety of a sunscreen product under supervised outdoor-use conditions   "
31191|NCT02877485|"     The purpose of this project is to determine if intranasal corticosteroids have an effect on     nasal obstruction in patients with nasal septal deviation.   "
31192|NCT02877472|"     To confirm 1) whether, compared with core decompression alone, core decompression with porous     tantalum rod implantation improves the hip joint function of patients with avascular necrosis     of the femoral head after femoral neck fracture surgery, 2) whether porous tantalum rod shows     favorable biocompatibility with the human body, and 3) whether this treatment method is     feasible for treating avascular necrosis of the femoral head after femoral neck fracture     surgery.   "
31193|NCT02877459|"     A multicenter, prospective, single-arm clinical investigation to evaluate the short term and     long term safety of a modified staged treatment algorithm using the AeriSeal System.   "
31194|NCT02877446|"     Chronic heart failure is a common disease. It is also a serious disease with a mortality of     50% at 5 years, representing a significant cost in terms of public health expenditure.      Heart transplantation represents the gold standard of care for terminal heart failure     patients reached the end of the disease despite optimal medical and surgical management of     their disease, with a survival rate of transplant patients by 90% at 1 year and 82% at 3     years.      Long term LVAD are an innovative technology available for more than a decade, developed in     part because of the shortage of cardiac grafts and high mortality among patients waiting for     transplants due to an important pending.      This technique is used substantially only for ten to fifteen years in the world. Survival     after implantation of latest devices reaches 80% at 1 year.      In France, this technique is intended for patients with terminal heart failure who ended     different pharmacological and invasive therapeutic resources available.      Currently, academic centers that offer the possibility of long-term LVAD support are     organized unicentric in order to centralize specialized care for these patients.      Indeed, patients candidates for the establishment of a long-term LVAD are rigorously selected     to ensure an acceptable survival.      However, practices vary considerably from one center to another in particular regarding:        -  Implantation indications,        -  Pre-implantation patient assessment,        -  Monitoring,        -  Implementation of pharmacological treatments, particularly anticoagulants or          betablockers.   "
31195|NCT02877433|"     This study aims to compare the clinical performance of 4 mm short implants supporting     cross-arch fixed reconstructions in the edentulous mandible either with a combination of two     short implants as distal support and two implants of conventional length placed in the     interforaminal region, or with a combination of four short implants as distal support and two     interforaminal implants of conventional length.   "
31196|NCT02877420|"     The investigators aim to test a curriculum of non-technical skills (NTS) training for     simulation-based training of colonoscopy. There is no known literature to date on the optimal     approach on how to teach NTS in endoscopy. The objectives are to evaluate a simulation-based     curriculum to teach NTS, to explore the relationship between NTS and other domains of     competency, and understand how NTS are acquired in endoscopic training.   "
31244|NCT02876796|"     The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976     (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose     administration in overweight and/or obese, but otherwise healthy, male adults.   "
31197|NCT02877407|"     -  objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal          hysterectomy for uterine prolapse        -  prospective randomized clinical trial        -  patient             1. 60yrs or more women and             2. POP-Q stage II with symptom or POP-Q III, IV regardless of symptom        -  number of patient: 146        -  randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy        -  follow up: postoperative 1 year        -  primary endpoint: recurrence rate             1. recurrence of uterovaginal prolapse POP-Q stage II-IV             2. recurrence of associated symptom        -  secondary endpoint             1. postoperative 1 year QOL, degree of satisfaction evaluation             2. operative time, estimated blood loss             3. hospitalization period, postoperative pain, return to normal activity   "
31198|NCT02877394|"     Constipation is a very common problem. Western style toilets that are nearly universal in the     United States require the person to sit on the toilet. However, results from uncontrolled     studies suggests that a squatting posture (as prevalent in many foreign countries) may be     better at facilitating evacuation compared to a Western style commode. One uncontrolled,     unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153     constipated participants. Hence, the investigators propose to evaluate the benefits of a     footstool on symptoms and anorectal functions in constipated patients. Hypothesis: the     regular squatting assist device (7 inches) but not a sham device (2 inches tall) will improve     symptoms of constipation.   "
31199|NCT02877381|"     To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA)     [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral     repeated dosing] to minimize post-operative blood loss and transfusion requirements following     revision total knee arthroplasty (RTKA).   "
31200|NCT02877368|"     The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the     arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly     targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor.     Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is     generally well-tolerated and known to improve performance status but up to 16% grades 3-4     toxicities, leading to at least 40% withdrawals, have been reported.      Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients     included in phase 1 trials, suggesting that it should be considered an inclusion criterion     for such studies. Sarcopenic patients had low performance status, shorter survival, more     chemotherapy toxicities and post-operative infections, and longer post-operative     hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib or     sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal cell     or hepatocellular carcinomas.      Computed tomography (CT) scans acquired during routine care have been validated as an     accurate and robust imaging technique to evaluate sarcopenia in cancer patients.   "
31202|NCT02877342|"     A prospective observational study using an interrupted time-series design to evaluate the     effect of pre-hospital notification on trauma patients arriving at a trauma centre by     ambulance, in India   "
31203|NCT02877329|"     Randomized trial comparing internet-delivered ACT with therapist support against waiting list     for persons with hearing loss and comorbid psychological distress   "
31204|NCT02877316|"     Background: Persons with a past episode of self-harm or severe suicidal ideation are at     elevated risk of self-harm as well as dying by suicide. It is well established that suicidal     ideation fluctuates over time. Safety plans in paper format are mandatory part of the     treatment regime in the suicide preventive clinics in Denmark. The aim of the trial is to     compare the paper version of the safety plan with a new-developed app in reducing suicide     ideation and other symptoms, as an add-on to the supportive psychotherapy delivered in the     clinics.      Hypothesis: It is hypothesized that participants randomized to MYPLAN will have lower suicide     ideation as well as improvements on the secondary outcomes than users who have the paper     version.      Methods: The trial is designed as a 2-arm observer-blinded parallel group randomized clinical     superiority trial, where participants will either receive: 1) Experimental intervention: the     safety plan provided as the app MYPLAN, or 2) Treatment as Usual: the safety plan in the     original paper format. Both intervention groups will also receive standard psychosocial     therapeutic care, up to 8-10 sessions of supportive psychotherapy.Based on a power     calculation a total of 546 participants, 273 in each arm will be included. They will be     recruited from national suicide preventive clinics. Follow-ups will be conducted at 3, 6, 9,     and 12 months after date of inclusion.      Participants, inclusion and exclusion criteria: There is no age restriction on participation     in the study and all participants will be recruited from the suicide prevention clinics in     Denmark. These clinics are highly specialized outpatient care centers, offering short-term     supportive psychotherapy and social counselling for suicidal patients. In order to     participate in the study, participants must have a smartphone (IPhone or android phone) and     understand sufficient Danish to use MYPLAN. Persons having a particularly severe alcohol or     substance abuse disorder, which might inflict with skills of orientation and memorywill not     be offered participation in the RCT.      Outcomes Patient reported outcomes (PROM) are collected at baseline and follow-up through     self-administered tablet/internet-based questionnaires. Primary outcome is suicide ideation.     Secondary outcomes are:, hopelessness, depressive symptoms, quality of life, and modified     CSQ-8.      Statistical analysis: Data analysis will be based on intention-to-treat principle. We will     examine this using repeated measurement in mixed models. Missing data will be handled with     multiple imputations.      The trial will start in November 2016 and patient recruitment is expected to finish November     2017. Analysis and results are expected in 2018.   "
31205|NCT02877303|"     The goal of this clinical research study is to learn if Blinacyto (blinatumomab), when given     after Hyper-CVAD, can help to control newly diagnosed B-Cell Lineage ALL. The safety of this     drug will also be studied.   "
31206|NCT02877290|"     In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance     cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without     in a randomized cross-over design. The aim is to measure, whether NIV is able to change     peripheral and respiratory muscle oxygenation.   "
31208|NCT02877264|"     This is a randomized, single-center, open-label, three-period, six-sequence, crossover,     comparative study to evaluate the oral bioavailability of single doses of three vapendavir     drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral     suspension [test drug], and two 132 mg phosphate salt capsules [reference drug]) in healthy     volunteers. The study design consists of six dosing sequences. Each sequence comprises 3     periods and each subject is administered one of the three dosing formulations in the first     period. A subject receives a different formulation in each of the subsequent periods, so that     all subjects receive each formulation. The periods are separated by an approximate 7-day     washout.   "
31209|NCT02877251|"     REMMITE, a retrospective and prospective registry with one-year follow-up, will provide     valuable insights into the clinical diagnosis, management, treatment trends as well as     related outcomes of three cohorts: DVT, DVT-PE, PE patients throughout many regions of Mexico     and through different health care systems.   "
31210|NCT02877238|"     Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may     mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.   "
31212|NCT02877212|"     Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease characterized by     antibody-mediated platelet destruction. The complex pathogenesis of ITP with multiple     challenges to immune system in terms of genetic predisposition, infection, responsiveness to     immunosuppressive therapy (IST) and inhibition of platelet production has proven the     diversity of constraints in diagnosing and treating ITP. Thrombopoietin receptor agonist     (Eltrombopag) is specifically indicated for the treatment of thrombocytopenia in patients     with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient     response to corticosteroids, immunoglobulins, or splenectomy. This clinical trial aims to     investigate the association of Fc gammaRIIIA gene (V158F) genetic predisposition with     treatment outcome of Immune Thrombocytopenia (ITP) in refractory ITP patients and especially     with Eltrombopag.   "
31213|NCT02877199|"     The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the     on-treatment viral kinetics and could predict virological outcome in treatment-experienced     HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.   "
31214|NCT02877186|"     This pilot study is being conducted to evaluate whether consumption of diet soda sweetened     with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a     one week run-in period, healthy, young adults are randomized to consume either diet soda or     carbonated water (control) three times per day for one week. Stool and urine samples are     collected at baseline, following the run-in, and after the one-week intervention.   "
31215|NCT02877173|"     A phase II,randomized,double-blind,multi-doses,positive drug parallel controlled,multi-center     clinical trial to evaluate initially the efficacy and safety of alprostadil liposomes for     injection in the treatment of atherosclerotic occlusive disease of the lower extremities.   "
31216|NCT02877160|"     This study is a single-center, randomized, open-label crossover study to assess the     pharmacokinetics and food effect of AL-794 formulations in healthy subjects.   "
31217|NCT02877147|"     The Summer Electronic Benefit for Children (SEBTC) demonstration provided food assistance to     households with school-aged children during the summer through electronic benefit transfer     (EBT) procedures used by the Supplemental Nutrition Assistance Program (SNAP) and Special     Supplemental Nutrition Program for Women, Infants and Children (WIC) programs. The evaluation     design included two components: an impact study and an implementation study. The evaluation     assessed the impact of SEBTC on children's food security and nutritional status, household     food expenditures and purchasing behaviors, parental perceptions, and participation in     nutrition assistance programs. The implementation study analyzed SEBTC use patterns using     administrative data, and described demonstration implementation and costs.   "
31218|NCT02877134|"     The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants     with moderately to severely active Crohn's disease.   "
31219|NCT02877121|"     The purpose of this study is to assess the Respiratory Muscle Function and Neural Respiratory     Drive in Interstitial Lung Disease patients.   "
31220|NCT02877108|"     There is limited information on the best psychoactive medication to treat agitated patients     in the emergency department. The intent of this study is to fill in knowledge gaps in the     current practice of treating psychiatric patients in the acute care setting. The purpose of     this study is to determine the best treatment for agitated psychiatric patients in the     emergency department.   "
31221|NCT02877095|"     The Pilot study is designed to evaluate the overall safety and feasibility of a strategy     based on subcutaneous delivery of furosemide. It will be used to inform the subsequent     evaluation phase of the study (separate protocol). The primary objective of the study is to     determine if a strategy of a novel subcutaneous delivery of furosemide is safe and feasible     in patients with acute heart failure.   "
31222|NCT02877082|"     This phase II trial studies how well tacrolimus, bortezomib, and anti-thymocyte globulin     (thymoglobulin) work in preventing low toxicity graft versus host disease (GVHD) in patients     with blood cancer who are undergoing donor stem cell transplant. Tacrolimus and     anti-thymocyte globulin may reduce the risk of the recipient's body rejecting the transplant     by suppressing the recipient's immune system. Giving bortezomib after the transplant may help     prevent GVHD by stopping the donor's cells from attacking the recipient. Giving tacrolimus,     bortezomib, and anti-thymocyte globulin may be a better way to prevent low toxicity GVHD in     patients with blood cancer undergoing donor stem cell transplant.   "
31223|NCT02877069|"     This study will evaluate the safety and effectiveness of VYC-12 hyaluronic acid (HA)     injectable gel for filling fine lines, as measured by skin texture improvement, and for     improvement of skin quality.   "
31224|NCT02877056|"     The goal of this laboratory research is to look for genes that can predict which patients     will achieve a complete disappearance of their colorectal cancer after treatment like     chemotherapy, radiation, or other therapy.   "
32357|NCT02862223|"     This open-label study investigated the effectiveness of Neprinol on maintaining healthy     cardiovascular health in overweight and obese adults. Subjects took 3 capsules, 3 times per     day over a period of 12 weeks.   "
31225|NCT02877043|"     In 2009, centres that carried out lung resection for cancer were required to obtain     authorization following the first cancer plan. One of the criteria to obtain authorization     was the volume of activity: the centre had to carry out at least 30 lung resections per year     for cancer. Five years later, it would be useful to know the impact of this new organization     of oncology on the quality of care. To answer this question, the PMSI database is an ideal     source of an indicator of quality: in-hospital mortality. This observational cohort study     will be conducted using the national PMSI database with data covering the period from 1st     January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection.     The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period     2008-2010 includes the implementation of authorizations for cancer surgery.   "
31226|NCT02877030|"     Testing the effectiveness of an exercise protocol engines sensory performed through a virtual     reality platform in individuals infected with HTLV-1   "
31245|NCT02876783|"     Observe and describe the relationships between impairments and function, systematically     characterize recovery patterns and examine short and long term rehabilitation outcomes. This     project is purely observational, descriptive and non-experimental. N=273   "
31227|NCT02877017|"     Miscommunications are a leading cause of serious medical errors in hospitals, contributing to     more than 60% of sentinel events, the most serious adverse events reported to the Joint     Commission. Efforts to improve patient safety in hospitals have centered on improving     communication between providers. While provider-focused communication interventions have led     to reductions in patient harm, patients and families have been notably absent from most     interventions to improve patient safety. This proposal seeks to develop and investigate the     effectiveness of a family safety engagement intervention aimed at reducing harm in     hospitalized children.   "
31228|NCT02877004|"     The purpose of this research is to gather preliminary information on the effectiveness of Low     Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body     region.   "
31229|NCT02876991|"     The purpose is to evaluate if sodium fluoride PET in patients having already undergone a     choline PET negative for bone extension (non-metastatic status) modifies the status of     patients concerning the existence or not of bone metastases.      Secondary purposes are:        -  To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by          choline PET, leads to change of treatment        -  To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results          (metastatic status and number of lesions)        -  To evaluate the inter-judge concordance of interpretation of sodium fluoride PET        -  To study the discordance of metastatic status of 2 techniques.   "
31230|NCT02876978|"     The purpose of this study is to observe and confirm the safety, tolerance and cell     pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)   "
31231|NCT02876965|"     This study evaluates the effect to a muscle stretching program combined with physical     exercise versus a physical exercise program in patients with fibromyalgia.   "
31232|NCT02876952|"     Acute myocardial infarction (MI) continues remains to be a major cause of death and     disability worldwide. Exercise therapy has long been used for rehabilitation purposes and the     benefit of regular physical exercise is also well established. The intensity of aerobic     exercise training is a key issue in cardiac rehabilitation programmes.Endurance aerobic     training is typically performed as continuous training at moderate to-high exercise intensity     in steady-state conditions of aerobic energetic yield. However, interval training (i.e.,     repeated bouts of short-duration, high to severe- or severe to extreme-intensity exercise,     separated by brief periods of lower-intensity) has been proposed to be more effective than     continuous exercise for improving exercise capacity. Adding to that, health-related     adaptations to low-volume and high intensity interval training have been presented.      On the other hand, the Mediterranean Diet has been widely reported to be a model of healthy     eating for its contribution to a favourable health status and a better quality of life,     reducing in overall mortality from cardiovascular diseases.      Considering all the above mentioned in MI population, the principal objective for the     INTERFARCT study will be to assess the effects of different programs of high intensity     aerobic interval training and Mediterranean Diet recommendations in the clinical condition,     cardio-respiratory fitness, biomarkers, ventricular function and perception of quality of     life after myocardial infarction.      Methods/Design: One hundred and fifty people after suffering acute MI will perform different     assessments to evaluate clinical history, physical, biochemical and nutritional condition,     and quality of life before and after 16-week of follow-up. All participants will receive     Mediterranean diet recommendations and will be randomly assigned to attention control group     (diet and physical activity recommendations) or exercise groups (diet recommendations plus     high-intensity aerobic interval exercise). Participants assigned to an exercise group will     train 2 days/week under supervision (day 1-treadmill and day 2-bike protocol). There will be     two aerobic exercise groups: 1) high-intensity interval training and high-volume (HV-HIIT)     group, and 2) high-intensity interval training and low-volume (LV-HIIT) group.   "
31233|NCT02876939|"     This project comprises three sets of physiological studies - testing eight specific     hypotheses - that will contribute new knowledge on proprioception and motor control in a     genetic disorder that affects specific components of the sensory nervous system.      I: To investigate the neurophysiological basis for disturbed motor control in Hereditary     sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing     cutaneous feedback on motor control in HSAN III III: To investigate the cortical     representation of proprioceptive inputs in HSAN III   "
31234|NCT02876926|"     This study explores whether offering follow-up counseling and referral over the phone after     using a home-based HIV test increases rates of ever and repeat testing, compared with     home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based     testing.   "
31235|NCT02876913|"     The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the     surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are     often not fitted in anatomy of Korean people because of small nostril. When the size of the     tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the     glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and     depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are     scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome     is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the     proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length     from the nare to the carina and vocal cord are measured.   "
31236|NCT02876900|"     This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo     transdermal patch in subjects diagnosed with schizophrenia.   "
31237|NCT02876887|"     The COCOA-PAD trial will determine whether epicatechin-rich cocoa daily for six months     improves walking performance in individuals with peripheral artery disease compared to     placebo.   "
31238|NCT02876874|"     To observe the relationship between the activity of rheumatoid arthritis and     popliteal/epitrochlear lymph node morphology and the drainage of hand/foot superficial     lymphatic vessels   "
31240|NCT02876848|"     Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine     therapy (AET) is associated with a significant survival advantage. Nonadherence is a     particular challenge in older women, even though they stand to benefit the most from AET.     Therefore, a novel e-health tool (OPTIMUM) that integrates real-time analysis of health     administrative claims data was developed to provide point-of-care decision support for     clinicians.   "
31241|NCT02876835|"     The purpose of this multi-center event-driven study in non-dialysis (ND) participants with     anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of     daprodustat compared to darbepoetin alfa.   "
31242|NCT02876822|"     The purpose of this study is to test the efficacy and safety of high dose vitamin D therapy     among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment     doses capable of providing vitamin D sufficiency.   "
31243|NCT02876809|"     This study evaluates the associations between biomarkers of ageing, comprehensive geriatric     status, telomere length and progerin level, the composition of the gut microbiota, 16sRNA     metagenome sequencing in Moscow centenarians.   "
31246|NCT02876770|"     The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion upon     short-term performances, on the following morning. Twelve soccer players from a Tunisian     squad (22.9 ±1.3 years, 1.80±0.05 m, and 72.0±8.8 kg) were volunteered to perform three     testing sessions, with one test session per day. During each session, MEL (5mg) , MEL (8mg)     or placebo were ingested, in a randomized order, before nocturnal sleep. The next morning     (08:00h), participants performed the following psycho-cognitive and physical tests: Hooper's     index, reaction time, vigilance, handgrip strength , squat jump , modified agility test ,     Wingate anaerobic test (peak power , mean power and fatigue index ). Rating of perceived     exertion was recorded immediately after the WanT, and blood lactate measures were taken after     3min of recovery. Blood glucose was measured before and 3 min after the Wingate test.   "
31247|NCT02876757|"     In December 2015, Health Canada issued a warning about a potential relationship between     suicide and finasteride use and called for further research. No population based studies have     assessed the risk of suicide with finasteride use, and this risk is not currently part of the     product monograph. Furthermore, the link between depression and finasteride has not been well     studied in the older population who are the primary users of this medication.   "
31248|NCT02876744|"     The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term,     a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The     accuracy of the analysis of the vascularization of retinal layers of the posterior pole of     the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there     are areas of macular ischemia in a patient. However, current technical limitations (small     field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole     of the fundus.      This study seeks to demonstrate whether there is a link between macular ischemia detected by     the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in     diabetic patients.   "
31249|NCT02876731|"     Prospective, monocentric, comparative, non randomised      Primary objective :      - to compare the diagnostic accuracy of sodium fluoride PET-CT and MRI using the conventional     block and diffusion sequence in the search for bone metastases      Secondary objectives :        -  compare accuracy of MRI diffusion and conventional MRI        -  explore the evolution of the results of the different types of imaging over time or          under treatment for patients with repeated examinations at 6 months   "
31250|NCT02876718|"     The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation     (NVAF) patients towards different options of an anticoagulation treatment.      Patient preferences for anticoagulant treatment attributes (convenience attributes only),     based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of     switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient     treatment satisfaction will be documented, measured by score differences of the Anti-Clot     Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.   "
31251|NCT02876705|"     The purpose of this study will be to study the individual spatiotemporal structure and     dynamics of topologically defined areas of perceived body discomfort and pain during     exercise. Participants will perform two constant tests (cycling and running) at an intensity     corresponding to Borg's scale of Rating of Perceived Exhaustion (RPE) (6-20) = 15 (i.e.,     hard). Using a body map template, participants will report every 15s the perceived locations     with discomfort and pain independently of the magnitude of the discomfort and pain.   "
31252|NCT02876692|"     This is a prospective cohort study:        1. First step: to establish a new scoring system for predication of delayed graft          function(DGF) following kidney transplantation based on previous and new study data. The          new scoring system is comprised of two parts: Xi'an Criteria of donor scoring system and          kidney evaluation System based on Lifeport platform ).        2. Second step: validate the new scoring system through prospective cohort study in our          transplantation center and modify the scoring system if needed. Recruiting 300 patients,          follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be          followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR), graft          survival and patient survival        3. Step 3: Further validate the new scoring system in six other transplantation centers and          developing a software in the end. Recruiting 300 patients, follow up at day 3, week 1,          month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF, PGF,          AR, graft survival and patient survival   "
31253|NCT02876679|"     The study is designed as a two arm randomized Phase II, multicenter trial comparing     cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis     in patients with hematologic malignancies undergoing reduced intensity conditioning     hematopoietic stem cell transplantation.   "
31254|NCT02876666|"     The SCI Virtual Coach study has developed an on-screen, human-like character that will     provide support, education and coaching to adults with spinal cord injury (SCI) to aid in the     prevention of serious secondary conditions like pressure ulcers. In a randomized controlled     trial, participants assigned to the Coach intervention will have a touch-screen computer     placed in their homes and be asked to interact with the Coach on a daily basis for 2 months.     Participants will be asked to complete surveys at baseline and 2 months.      The SCI Virtual Coach study aims to measure how accessible and usable participants feel the     Coach is, as well as participants' adherence to the Coach's instructions. It will also gauge     how effective the Coach is in changing self-care knowledge, health care behaviors,     self-efficacy for self-care, and perception of social support in participants.   "
31255|NCT02876653|"     Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can     lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is     difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity),     promoting themselves aging. The investigators propose to compare a group of OSAS patients     free of any associated pathology, to subjects matched for age, sex, smoking and body mass     index (BMI)   "
31256|NCT02876640|"     This phase Ib trial studies how well retinoid 9cUAB30 works in producing a biologic effect in     patients with early stage breast cancer. Chemoprevention is the use of drugs to keep breast     cancer from forming or coming back. The use of retinoid 9cUAB30 may slow disease progression     in patients with early stage breast cancer.   "
31257|NCT02876627|"     Introduction: The purpose of this study was to determine the effect of twelve weeks of     aerobic exercise program on erythrocyte levels in women with breast cancer after     chemotherapy.      Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged     between 47-65 years) volunteered for this study, and then randomly selected an exercise (n =     15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise     training program consisted of three sessions per week, each session lasting 30 to 60 minutes     50 to 75 percent of their maximum heart rate reserve, while the control group were followed.     Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak     oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis     of data, repeated-measures analysis of variance (ANOVA) was used.   "
31258|NCT02876614|"     Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal     injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for     two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of     normal pressure hydrocephalus.      In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF     unlike other reference tests.      In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and     throat of the patient to collect a possible flow of CSF.      These samples are analysed by radioactivity measurements and bring an added value to the     exam.      The interest of this examination for management of CSF leak/fistula remains unclear.      The aim of this study is to identify and analyse results of all RC examinations performed     since 2005 in the Nuclear Medicine department of the Neurological Hospital.      The full analysis of patients will allow discussing the role of RC in management of CSF     leak/fistulae in clinical practice.   "
31259|NCT02876601|"     Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of     veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact     mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be     investigated in the human endotoxemia model in order to gather further information on its     actions.   "
31260|NCT02876588|"     Currently, at least 70,000 U.S. physicians use computerized provider order entry (CPOE) to     place orders. This number is expected to rise sharply as hospitals continue to take advantage     of federal incentives and adopt electronic health record (EHR) technology. Although CPOE is     associated with a reduction in medical errors, when orders are placed electronically certain     types of errors, including placing orders on the wrong patient, may occur more frequently.     The mechanism by which multiple patient records opened simultaneously can lead to     wrong-patient errors may be related to the ease with which users can toggle between patient     records and the similar looking computer screens. The magnitude of this risk needs to be     established to help Health Information Technology (IT) leadership decide how to safely     implement CPOE systems. There have been no studies demonstrating whether multiple records     increase the risk of wrong-patient errors, by how much, and if any increase is dependent on     the number of records open. This research project is an important first step in quantifying     this risk.This will be the first study to achieve the following aims:        1. Assess the relationship between the number of records open at the time of placing an          order and the risk of placing an order on the wrong patient.        2. Compare the incidence of wrong-patient orders in a restricted environment that limits          providers to only one record open at a time to an unrestricted environment where users          can open a maximum of four records at once.        3. Use results to inform a larger-scale health IT implementation research project          evaluating the balance between the wrong-patient error risks and potential efficiency          gains of having multiple records open at once, with rigorous research methodologies.        4. Disseminate results to help inform decisions on how to safely implement EHR systems.   "
31261|NCT02876575|"     The purpose of this study is to assess the severity of post-operative pain following the use     of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in     Europe) tonsillectomy procedures.   "
31262|NCT02876562|"     Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for     augmenting keratinzed gingiva , improved wound healing, recession coverage in localized     gingival recessions and multiple recession coverage.      However there are very few randomized controlled clinical trials in the literature that     compare collagen matrix versus connective tissue graft in the management of multiple     recession type defects. To the best of our knowledge there is only one randomized controlled     trial that compares modified coronally advanced tunnel+connective tissue graft with collagen     matrix in the management of multiple gingival recessions.      Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the     management of Millers class I and II multiple gingival recessions. The use of collagen matrix     in combination with Modified Coronally Advanced Tunnel as a surgical technique will be     compared for recession coverage.   "
31280|NCT02876328|"     The purpose of this study is to evaluate the safety and immunogenicity of three vaccine     strategies that may prevent Ebola virus disease (EVD) events in children and adults.     Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA)     boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.   "
38549|NCT02781025|"     The purpose of this study is to investigate the feasibility of using novel decellularized     tissue matrices to isolate and culture circulating tumor cells (CTCs) collected from patients     with metastatic solid tumor malignancies.   "
31263|NCT02876549|"     This will be a single-arm observational cohort study. Malaria patients with Plasmodium vivax     and meeting study inclusion criteria, who give consent to be enrolled in the study, will have     their G6PD status measured by the CareStart™ G6DP rapid diagnostic test (G6PD RDT), and     primaquine prescribed according to the result. According to the G6PD RDT result, primaquine     will be prescribed at 0.25mg/kg/day for 14 days (normal patients) or 0.75mg/kg weekly for     eight weeks (deficient patients). All will receive treatment with chloroquine to clear     asexual stages of infection.      Patients will be reviewed at day 2, day 7 and day 14. At these visits patients will undergo a     brief clinical assessment and a small blood sample will be taken for repeat haemoglobin     measurement and dried blood spot for carboxyprimaquine measurement (day 7 and day 14 only).      In general, antimalarial treatment will be unsupervised to reflect field conditions. However     a subset of 25 G6PD normal patients at a single site will have each day of their primaquine     treatment administered and observed at the treatment centre. This is to determine a     calibration curve for primaquine pharmacokinetic studies.      Dried blood spots will be stored appropriately. Day zero samples will be genotyped in Bangkok     (MORU, Dr. Mallika Imwong) after DNA extraction. PCR-RFLP will be used to detect the allele     associated with the Mediterranean variant of G6PD deficiency. In addition DNA extracts will     be sent for more systematic genetic testing for known G6PD variants through existing     collaborations with the Wellcome Trust Sanger Institute. The day 7 and 14 dried blood spot     samples will be analysed in the MORU pharmacology laboratory for primaquine and     carboxyprimaquine concentrations, from which adherence to primaquine can be determined     retrospectively, using the subset of 25 patients receiving directly observed therapy to     calibrate the results.   "
31264|NCT02876536|"     The aim of this study is to evaluate whether the Transcutaneous Electrical Nerve Stimulation     (TENS) is effective on improvement of cognitive disorders in Multiple sclerosis patients.   "
31371|NCT02875132|"     To determine the Overall Response Rate (ORR), as defined as rate of complete response (CR)     and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with acral     lentiginous melanoma treated with pembrolizumab   "
31265|NCT02876523|"     The management of hilar biliary strictures remains difficult. These strictures are classified     in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed     in types I and II while a percutaneous drainage is performed in type IV. There is controversy     as to whether partial or complete liver drainage should be done. Furthermore there are no     standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a     multistage procedure can be required.      This study aims at evaluating the clinical practices in the investigators' center in order to     determine the key factors that contribute to the drainage success or failure.   "
31266|NCT02876510|"     In the IMA101-101 study, patients with relapsed and/or refractory solid cancers will be     treated with autologous CD8+ T-cell products (IMA101) specific for novel targets from the     ACTolog warehouse that have been identified by the XPRESIDENT target discovery platform.      ACTolog is an actively personalized immunotherapy approach in cancer treatment. The ACTolog     clinical trial IMA101-101 is a first-in-human trial for the ACTolog concept for patients with     advanced stage solid cancers.      The goal of this clinical research study is to learn about the safety of giving IMA101 to     patients with advanced cancer. IMA101 is made with T cells (a type of immune cell) that are     grown in the laboratory. Researchers also want to learn if IMA101 can help to control the     disease.   "
31267|NCT02876497|"     Surgical samples of human primitive breast: Representative and various surgical samples of     human primitive breast carcinoma in terms of histological type. Moreover, healthy tissue from     the same patient will be analysed in parallel. Adjacent normal epithelial structures will be     defined as at least 5 mm away from the tumor and histologically normal in appearance.      Isolation, differentiation of human monocyte-derived Macrophages (Mphs) and determination of     the Macrophage (Mph) migration mode : Human Mphs will be differentiated from blood monocytes     isolated from the same patient than the tumor sample. Blood samples will be obtained     following standard ethical procedures.   "
31268|NCT02876484|"     The purpose of this study is to examine the effects of bile acid and bile acids sequestrants     on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.   "
31269|NCT02876471|"     Emerging evidence suggests that there is a causal link between obstructive sleep apnea(OSA)     and hypertension. Patient with this syndrome exhibit several characteristics: high     prevalence, frequent non-dipper status, diastolic and nocturnal predominance, which are     related to clinical and subclinical organ damage in heart and brain. However, the influence     of OSA on nocturnal hypertension development has not yet been clarified. Blood pressure     variability (BPV) plays a role in vascular damage, independent of blood pressure. Apnea     overloads the autonomic cardiovascular control system and may influence BPV,which is     classified by different time interval, including beat-to-beat, hour-to-hour day-to-night     changes or long-term, for example days, weeks, months, seasons, and even years. All BPV     abnormalities are associated with an increased incidence of cardiovascular events and     mortality. The investigators pre-experiment estimate BPV by ambulatory blood pressure     monitoring (ABPM), which unable to capture the BP fluctuation accurately during the apnea     event. The small studies exam beat-to-beat BP and OSA，and the investigators can't couple the     events with blood fluctuation, also incapable calculate the correlation of them. This study     is aimed to use pulse transmit time(PTT) based blood pressure measurement which can be useful     for continuous monitoring of blood pressure to monitor nocturnal beat-to-beat blood pressure     fluctuation in OSA with or without hypertension, investigating the degree of relevance     between hypoxia, AHI, nocturnal hypertension development and BPV. Besides that the     investigators also evaluate the effect of continuous positive airway pressure(CPAP) on blood     pressure and nocturnal beat-to-beat BPV.   "
31270|NCT02876458|"     Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The     most common cause of SCD is acute coronary artery occlusion. Several registry based studies     suggest that coronary angiography (CA) performed at admission followed if necessary by     coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend     performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of     arrest. However there is a lack of randomized data on this topic.      Several retrospective studies have shown that if the post-resuscitation electrocardiogram     (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion     during the CA is high (70-80%). In contrast, if no ST segment elevation is present the     probability is low (15-20%).      Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting     these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA.     It may increase the delay of performing other therapeutic modalities such as CT brain or     thorax scan to determine the cause of SCD. Performing the CA 48 to 72 hours after admission     would facilitate the management of these difficult patients. However if the cause of the     arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of     post-arrest shock and the mortality may increase. Therefore a randomized study comparing     immediate versus delayed (between 48 to 72 hours) CA in survivors of SCD with no obvious     non-cardiac cause of arrest is warranted.   "
31271|NCT02876445|"     Huntington's disease (HD) is a rare inherited neurodegenerative disorder, progressing between     15 and 20 years and affecting one person out of 10.000. In France, it concerns some 6.000     patients symptomatic and 12 000 asymptomatic carriers.      Few extensive researches have been conducted on the progression of the disease, which is     defined in the literature in 5 stages in a functional approach.      Therapeutically, no cure for HD is currently validated but only symptomatic treatments.     There's various treatment options: medicated, humans (physiotherapy, speech therapist,     occupational therapist, ..).      Although these treatment options do not prevent the progression of the disease, their     combination associated with a stimulating environment may slow the decline of physical,     intellectual and psychic abilities of patients.      In social terms, patients with HD require sustained support, especially in cases of family     isolation.      The behavioural, gaiting and eating disorder as well as the communications difficulties make     it difficult support daily for the entourage. The caregivers are sometimes dealing with     untenable situations. Home care services, which are crucial to alleviating dependency,     relieve family caregivers but are for the most severe patient.      Moreover, the justified placement decision in an institution generates a feeling of guilt for     the family.      The caregiver is the person who brings non-professional assistance , partly or wholly , to a     dependent member of his entourage , for the activities of daily living. This regular care may     be provided permanently or not. It can take many forms, such as , care , nursing , support to     education and social life , administrative procedures , psychological support .      Caregivers have their lives profoundly reshaped. They are often forced to give up some of     their habits , give up their future plans , change their relationships. The commitment of     caregivers with patients with Huntington's disease actually sounds on their mental and     physical health, as well as their social and professional life      Very few studies have been conducted to measure the difficulties and implications of these     caregivers.   "
31273|NCT02876419|"     The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B /     hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In     this protocol, similar reduction/clearance of serum HBsAg and improved response to     immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol     was designed to include a 24 week follow-up period after treatment, however given the strong     antiviral response against HBV and HDV infection in these patients, it is now important to     extend the follow-up period in these patients to monitor over a longer period after treatment     the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301     protocol.   "
31274|NCT02876406|"     This study evaluates the usefulness of the ΔvapCO2 / Cav02 ratio to predict complications     after elective cardiac surgery, comparing it with others markers such as lactate,     arteriovenous CO2 difference (ΔvapCO2) and would try to developed a new predictive score for     postoperative complications.   "
31275|NCT02876393|"     Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with     diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to     the high and fluctuating sugar levels in the blood stream. An eye with DR will have abnormal     appearing retinal blood vessels which become engorged and dilated, leaky and fragile or     undergo closure. The net result is a picture of haemorrhage and or ischaemia (lack of blood     supply). A particular feature of DR is the accumulation of fluid in the macula which is the     central part of the retina and responsible for detailed eye sight. This peculiar form of DR     is called Diabetic Macular Oedema (DMO). DMO can occur in isolation without other features of     DR. DMO is commoner in type 2 diabetes where insulin resistance and abnormalities of blood     fats are found. The investigators wish to study DR and DMO using high resolution retinal     imaging and functional tests in normal participants, those participants with diabetes without     any overt signs of disease and those with DR and DMO in order to understand how the condition     develops and whether there are any unique risk factors that can be identified   "
31276|NCT02876380|"     The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on     12 lead electrocardiogram (ECG), strengthened by a positive family history and/or     characteristic arrhythmias and confirmed by genetic testing. However, for several reasons     such LQTS testing cannot be performed successfully before birth. First, fetal ECG is not     possible and direct measure of the fetal QT interval by magnetocardiography is limited to     fewer than 10 sites world-wide. Second, while genetic testing can be performed in utero,     there is risk to the pregnancy and the fetus. Third, although some fetuses present with     arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular     (AV) block, this is uncommon, occurring in <25% of fetal LQTS cases. Rather, the most common     presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is     unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and     undiagnosed during fetal life, with dire consequences. For example, maternal medications     commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal fetal     ventricular arrhythmias. But the most significant consequence is the missed opportunity for     primary prevention of life threatening ventricular arrhythmias after birth because the infant     is not suspected to have LQTS before birth. The over-arching goal of the study is to overcome     the barriers to prenatal detection of LQTS. The investigators plan to do so by developing an     algorithm using fetal heart rate (FHR) which will discriminate fetuses with or without LQTS.      Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study     to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses     recruited from 13 national and international centers where one parent is known by prior     genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-gated     channel subfamily Q member 1 (KCNQ1), potassium voltage-gated channel subfamily H member 2     (KCNH2), or sodium voltage-gated channel alpha subunit 5 (SCN5A). The investigators have     chosen this population because 1) These mutations are the most common genetic causes of LQTS,     and 2) Offspring will have high risk of LQTS as inheritance of these LQTS gene mutations is     autosomal dominant. Thus, progeny of parents with a known mutation are at high (50%) risk of     having the same parental LQTS mutation. The algorithm will be developed using FHR measured     serially throughout pregnancy. All offspring will undergo postnatal genetic testing for the     parental mutation as the gold standard for diagnosing the presence or absence of LQTS.   "
31277|NCT02876367|"     This study to collect and identify rodents and mites across transects through diverse     habitats used by the human community from a localised area identified as a scrub typhus 'hot     spot'.   "
31278|NCT02876354|"     Vitamin K2 deficiency has been shown to be profound in hemodialysis patients. It is reflected     by high plasma levels of dephosphorylated-undercarboxylated Matrix Gla protein (dp-ucMGP) and     seems to be correlated with vascular calcifications. Vascular calcifications can be assessed     using the AC24 score on a lateral abdominal X-ray.      The aim of this study is to assess first the rate of decrease of dp-ucMGP in a hemodialysis     cohort after supplementation with vitamin K2 and the correlation between this rate of     decrease and the Aortic Calcification Severity (AC24) score. The factors associated with high     levels of dp-ucMGP will be analyzed as well.   "
31279|NCT02876341|"     Retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on     new onset atrial fibrillation and clinical outcomes in septic shock.   "
33076|NCT02852824|"     The primary objective of this trial is to investigate the safety and tolerability of BI     655130 in healthy male subjects following IV administration of multiple rising doses. The     study will also explore safety and tolerability following a single IV administration.   "
31283|NCT02876289|"     Perampanel is a non-competitive antagonist of the AMPA (     2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved     by the European Medicines Agency as adjunctive treatment for partial-onset seizures in     patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and     safety of perampanel as add-on treatment in patients with refractory epilepsy.      The investigators retrospectively collected and analyzed the data of patients with refractory     epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In     total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean     duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD =     2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the     responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were     reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%),     dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).   "
31284|NCT02876276|"     Hyaluronic acid (HA) has been used as a dermal filler in medicine for many years. It also has     umpteen benefits in terms of aiding in rapid healing and resolution of inflammation. Thus in     the present study, HA has been used at the test site to fill papillary recession defects. At     the control site saline was injected as the placebo.   "
31315|NCT02875860|"     This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO)     rather than expectant management during pregnancy, followed by standardized postnatal     management, increases survival at discharge and decreases oxygen need at 6 months in case of     survival till discharge.   "
31285|NCT02876263|"     The aim of this prospective, explorative study of noninvasive neuromonitoring was to search     potential and practical methods associated with neurological outcome in the perioperative and     immediate postoperative setting of surgery of the thoracic aorta. These methods include     abbreviated EEG monitoring, near-infrared spectroscopy, transcranial Doppler ultrasound and     biochemical markers associated with neuronal damage.   "
31286|NCT02876250|"     The morbidity and mortality of patients undergoing lung transplantation in the acute phase     following surgical intervention is mainly due to the primary graft failure (PGF).      The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury.     The pulmonary graft suffers two periods of ischemia one when it is explanted from the donor     (cold ischemia) followed by another when it is grafted into the recipient's thoracic cavity     (warm ischemia). The brutal reperfusion of the graft exposes it to reperfusion injury that     causes PGF. PGF occurs in up to 20% of transplanted patients and is associated with     significantly higher levels of 30-days all-cause mortality. Patients with PGF have a 40%     mortality at 30-days versus a 6% mortality in patients without PGF.      Ischemic postconditioning, has recently been described in experimental models of     ischemia-reperfusion injury in the heart, and although not yet fully understood. Several     studies suggest that the mitochondria play a central role in cellular survival mechanisms     after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability     transition pore (mPTP)).      Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion     binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective     effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in     clinical phase II trials in reperfused myocardial infarction patients.      The hypothesis of this study is that the administration of CsA in transplanted patients     (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s)     from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency and     severity of PGF.   "
31287|NCT02876237|"     The investigators propose to carry out a prospective analysis of physical impact,     psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of     localized prostate cancer with an indication of curative radiotherapy. This standardized     geriatric assessment will collect social information, functional, sensory, cognitive,     emotional, motor, nutritional, and medical related to comorbidities . The quality of life of     patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European     Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the     end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate     in this elderly population and will allow an answer within 2 years to the problem raised in     clinical practice.   "
31288|NCT02876224|"     This is an open-label, multicenter, single-arm, two-stage, Phase Ib study designed to assess     the safety, tolerability, and pharmacokinetics of oral cobimetinib with intravenous (IV)     atezolizumab and bevacizumab in participants with metastatic colorectal cancer (mCRC) who     have received and progressed on at least one prior line of therapy that contained a     fluoropyrimidine and oxaliplatin or irinotecan. There are two stages in this study: Stage 1     (safety run-in period) and Stage 2 (dose expansion with two cohorts, an expansion cohort and     a biopsy cohort).   "
31289|NCT02876211|"     Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is     a selective vitamin D receptor activator with potential benefits on anti-inflammatory     cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may     improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.   "
31290|NCT02876198|"     The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is     currently the standard treatment for retinal neovascularization. The VEGF stimulates     endothelial cells' proliferation and migration. It also increases microvascular permeability.     If the VEGFs have proven their efficiency in the decrease of choroidal neovascular     proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown.     Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in     the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have     an incidence on the loss of retinal nerve fibers.   "
31291|NCT02876185|"     Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension.     The treatment aims to stabilize the visual field deficiencies by lowering the intraocular     pressure. Due to the fluctuation of the visual field test and re-test measures, the European     recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in     order to know if the pathology is progressing despite the current treatment (or if the     treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists     renders the monitoring of a beginning glaucoma, rarely compatible with the present     recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when faced     to a decreasing medical demography and an increase the patient's needs.      This study should allow to validate the possibility to delegate monitoring tasks to     orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to     orthoptists would permit a better distribution of the ophthalmologist's activities.   "
31311|NCT02875912|"     This study will evaluate whether or not engaging family members of patients admitted to the     ICU in Family Care Rituals will reduce stress related symptoms of PTSD, depression and     anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are     defined as several domains in which family participation may be of benefit, focusing on the 5     physical senses as well as the personal care of the patient and spirituality of the patient   "
31312|NCT02875899|"     Prospective, single-arm, multicentre, international Registry of the Surfacer System for the     treatment of patients with limited or diminishing upper body venous access or pathology     impeding standard access methods.The purpose of this post-market Registry is to assess the     standard of care and clinical outcomes of the Surfacer System used in clinical routine     according to the approved commercial indications.   "
31313|NCT02875886|"     In this clinical study the anti-hypertensive response to dietary salt restriction is compared     with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult     patients with chronic kidney disease.   "
31314|NCT02875873|"     A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution     compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically     ill patients   "
31292|NCT02876172|"     This small study will look at the safety and estimate the strength of effect (effect size) of     a combination of Cognitive Behavioral Conjoint Therapy (CBCT) and     3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in ten pairs of people, one     with and one without PTSD. The pairs can be spouses or romantic partners, siblings or other     relatives or close friends. The study will measure PTSD symptoms, as well as symptoms of     depression, sleep quality and relationship satisfaction and functioning before and after a     one-month course of CBCT that includes two MDMA+CBCT visits. CBCT psychotherapy is designed     to treat PTSD and relationship problems in pairs in a close relationship, and MDMA-assisted     psychotherapy uses the experimental drug MDMA to enhance and strengthen psychotherapy. There     is evidence that each of these treatments, on its own, can help people with PTSD. The study     will also measure personality and how each member of a pair thinks about and behaves in     relationships and expresses emotions before and after having MDMA+CBCT. Pairs will have two     day-long sessions scheduled two weeks apart. During the first MDMA+CBCT session, both members     of the pair will receive 75 mg MDMA with the option of receiving a second dose of 37.5     approximately an hour and a half later. During the second session of MDMA+CBCT, subjects may     receive either 100 or 75 mg, with the decision concerning dose made by the researchers after     discussion with the subjects. An optional dose half the size of the initial dose will be     offered approximately an hour and a half later. Following informed consent and screening     there will be one enrollment visit over videoconference. Before the first MDMA+CBCT session,     there will be an introductory session including 3 segments of CBCT psychotherapy on the day     before the first MDMA session. The introductory session and the CBCT sessions will be done in     person at the study site. During each MDMA+CBCT sessions, two therapists will work with with     the pair. Blood pressure, heart rate and body temperature will be measured periodically     during each MDMA+CBCT session. The pair will stay at the study site overnight with a night     attendant on duty, and they will have an integrative psychotherapy session on the morning     after the MDMA+CBCT session. Each member of the pair will be contacted by the researchers for     a week after each MDMA+CBCT session. The pair will have CBCT and integrative sessions over     videoconferencing twice a week for two weeks following the on-site integrative session. One     month after the second MDMA+CBCT session, both participants will have an evaluation and     testing visit over videoconference and will complete measures of PTSD symptoms, sleep     quality, perceived growth related to experiencing a trauma, symptoms of depression, and how     people think and feel about emotions and their relationships. The member of the pair with     PTSD will also undergo an interview measure of PTSD symptoms. The pair will complete measures     and questionnaires three and six months after the second MDMA+CBCT session. The study is open     label, meaning the researchers and subjects will be aware of the doses of MDMA used in the     study. The study will test and compare changes in symptoms and relationship issues before and     after the course of psychotherapy.   "
31293|NCT02876159|"     This is a prospective pilot study designed to suggest differences in the immunologic response     to the seasonal influenza vaccine in people with regular vaccination history compared to     those vaccinated less regularly. Participants will receive one dose of the Food and Drug     Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will     be collected at standard time points. The duration of the study for each participant will be     approximately 1 month.   "
31294|NCT02876146|"     Study design to define improved management of patients with hepatic alveolar echinococcosis     treated with albendazole and especially make appropriate and timely decision of treatment     withdrawal .      Based on exploratory analysis of existing and newly developed biological and imaging exams,     for diagnosis and follow-up, and study of the relationship of these markers to the viability     of the parasite and/or the activity of the parasitic lesions The study included two series of     patients: operated on (curative hepatectomy) // non-operated on   "
31295|NCT02876133|"     Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in     most European countries. Colonoscopy has been shown to reduce CRC incidence, however its     effectiveness depends on the sensitivity to detect pre-malignant lesions.      Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel     tools for the early detection of colonic sessile serrated lesions (SSL). The investigators     will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL     detection.   "
31296|NCT02876120|"     The START study will implement osteoarthritis (OA) treatment recommendations to increase the     use of recommended treatment modalities and reduce non-desired events (e.g. unnecessary     referrals to secondary care, unnecessary use of costly imaging modalities and use of     treatment modalities supported by low quality of evidence). The purpose of the STavanger     osteoARThritis (START) study is to improve the quality of OA care and increase the     collaboration between health care professionals in primary health care and across health care     levels.   "
31297|NCT02876107|"     The goal of this clinical research study is to learn if adding panitumumab to the combination     of carboplatin and paclitaxel can help to control IBC when given before other standard     chemotherapy and surgery. The safety of these drug combinations will also be studied.   "
31298|NCT02876094|"     Several factors make the use of celecoxib in human SMA patients appealing including: 1)     low-dosing required for potential therapeutic effect (the corresponding dose in humans is     much lower than that commonly used in adults and children with; 2) favourable side effect     profile of this drug (particularly at the dosing required); 3) the fact that celecoxib     crosses the blood brain barrier and 4) demonstration of efficacy in a genetically and     pathophysiologically faithful animal mode. The investigators therefore believe that celecoxib     is a promising disease modifying therapy for SMA.   "
31299|NCT02876081|"     Lung cancer is the leading cause of cancer deaths in France, Europe and the world. 50% of     lung cancers are of the adenocarcinoma subtype. 60% of patients present with a metastatic     disease (stage IV) at the time of diagnosis. Approximately 10% of patients present with a     mutation of the epidermal growth factor receptor (EGFR) requiring an EGFR tyrosine kinase     inhibitor (EGFR-TKI), namely erlotinib, gefitinib or afatinib. For the majority of     chemotherapy-naïve patients without addictive mutation, platinum-based chemotherapy,     frequently the platinum - pemetrexed doublet, provides disease control rate of up to 70% and     improves survival from approximately 4.5 with best supportive care alone to 15 months.     However, patients with non-small cell lung cancer (NSCLC) usually relapse within 4 to 6     months and benefit from a second-line chemotherapy. Authorized drugs in this setting are     pemetrexed, docetaxel and erlotinib. The prescription of erlotinib for unselected patients     whose tumor does not harbor an EGFR mutation is questionable . In the second line setting,     docetaxel provides less than 10% of partial responses and progression-free survival of 10 to     12 weeks. There are no standard options following failure of two previous lines of standard     chemotherapy. In view of these modest results, new agents and therapeutic strategies are     greatly needed for this patient population.      Neurotensin (NTS) is a 13 amino acids peptide, present and biologically active in the central     nervous system and in periphery. At the peripheral level, NTS is released by the endocrine     cells of the intestinal mucosa after meals and acts as an endocrine hormone involved in the     postprandial regulation of the motor functions of the gastrointestinal tract. The effects of     NTS are mediated by three subtypes of receptor: NTSR1 and NTSR2 exhibit high and low affinity     for NTS, respectively, and belong to the family of G protein receptors; NTSR3 is a single     transmembrane domain receptor. Exogenous activation of NTSR1 leads to cell proliferation,     survival, mobility and invasion in cancer cells from diverse origin. These effects are the     result from the activation of kinases and effectors, such as PKC, MAPK, FAK, RHO-GTPase, RAS     and Src. The PKC activation may induce MAPK by direct stimulation of Raf-1, or by     transactivation of the EGFR. The activation of MAPK via NTSR1 is mainly associated with     uncontrolled cell growth. Both NTS and NTSR1 are expressed in 40% of lung tumors, whereas     they are never expressed in the normal tissue. NTSR1 high expression is a negative prognostic     factor in stage I to III operated lung adenocarcinomas. Sustained stimulation of NTSR1     results in the activation of MMP1, the release of EGF like ligands such as HB-EGF as well     as neuregulin 1 NGR1 (a specific ligand for HER3) followed by EGFR, HER2 and HER3     overexpression and activation. Accordingly, xenografted tumors expressing NTS and NTSR1 show     a positive response to erlotinib, whereas tumors void of NTSR1 expression have no detectable     response.      Afatinib (BIBW2992) is a small molecule, selective and irreversible erbB family blocker. In     preclinical models it effectively inhibits EGFR, HER2 and HER4 phosphorylation resulting in     tumour growth inhibition and regression of established subcutaneous tumours derived from four     human cell-lines known to co-express ErbB receptors.      Our claim is that patients harbouring the NTS/NTSR complex, without EGFR mutation, will     respond to afatinib due to the sustained activation of EGFR/HER2 under neurotensin     activation.      Presently, only EGFR mutated tumors are eligible to receive EGFR TKI representing 10% of all     lung cancer patients. The aim of this study is to evaluate the efficacy of afatinib, an EGFR     TKI, on lung adenocarcinomas, EGFR wild-type, bearing the NTS/NTSR1 complex with a high level     of expression. This subpopulation of patients represents approximately 20% of lung     adenocarcinomas.   "
31300|NCT02876055|"     Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in     severe postoperative pain, especially in the first 48 hours after surgery. The use of     interscalene brachial plexus nerve block remains the cornerstone for analgesia following     shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has     been increasing interest in its use for total joint arthroplasty.      Since the benefits of local infiltration analgesia within a comprehensive multi-modal     analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the     Investigators plan to assess and compare analgesia outcomes between three intervention     groups: single shot interscalene brachial plexus block (SISB), continuous interscalene     brachial plexus block (CISB), and local infiltration analgesia (LIA).   "
31301|NCT02876042|"     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM     NEO system in the commercial setting in subjects recently implanted under the CE-Marked     indication for resistant hypertension that also have evidence of heart failure with preserved     ejection fraction (HFpEF).   "
31302|NCT02876029|"     The study focus is on the possible improvement in glucose tolerance at a second standardized     meal that can be achieved when preceded by a test meal with a low GI and a high GP.   "
31309|NCT02875938|"     This investigation uses a single-subject, adapted alternating research design to compare two     different experimental conditions using music with lyrics combined with visual stimulation of     the written lyrics, to extend the emotional word effect to phrases, in order to stimulate     reading comprehension of the trained material for patients with aphasia. The two music     conditions include 1) music with sung lyrics simultaneously with silent reading of the     written lyrics; and 2) music with sung lyrics, followed by silent reading of the written     lyrics (i.e. priming with the music). A control set without music will be used additionally     within every third session to detect potential history and maturation effects. All conditions     will be followed by a silent reading phrase-completion task composed of written words from     the total combined sets of stimuli.   "
31303|NCT02876016|"     Bring elements of understanding to the study of brain organization bodily representations.     The body is organized into multiple, distinct levels of representation. The body schema is an     unconscious and dynamic representation of his body, updated constantly, resulting from the     convergence of multiple sensory information, which articulates with the motor systems to     participate in the genesis of the action. The self-image corresponds to a more abstract     representation of the body, covering symbolic and imaginary aspects drawn from the emotional     life of the individual. Finally, the body of another person engages simultaneously shared and     differential representational systems that allow understanding the actions of others while     preserving the identity of the agent responsible for the action. These various bodies     represented subtly interacting and participating in equilibrium, the self-awareness building     as being curious, social and acting. Brain organization bodily representations remains a     fundamental question still poorly explored that is of major scientific interest because of     its influence on identity and social construction, and the serious repercussions that are     their problems, also for the individual and society. This project aims to deepen this     hypothesis using a methodology combining functional imaging and awake surgery. The richness     of this project lies in the innovative methods of investigation, and in the plurality of     disciplines (neuropsychology, neurophysiology, neuroimaging and neurosurgery) and teams     (clinical and research) grouped for wear.      The subjects enrolled in this study are all candidates in patients with awakened provided     surgery for therapeutic reasons, and volunteer to participate in this experiment. Awake     neurosurgery is for patients with glial tumors, but also brain metastases and     intra-parenchymal cavernomas. A first experimental session will be held in pre-operative     period. Patients realize a functional magnetic resonance imaging (fMRI) brain to define a     precise functional mapping of cortical structures, including lateral occipital, involved in     body representation. The second experimental session will be conducted in the neurosurgical     intervention, practiced one to four weeks later.      This dual approach that combines the functional stimulation of a cortical area (imaging) and     functional inhibition (in surgery) allows you to make extremely robust scientific arguments     about the causal relationships linking structure and function   "
31304|NCT02876003|"     Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50%     of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical     debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to     improve second-line therapy in GBM have met with only marginal success and there is a large     unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug     chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is     expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM,     but not by normal cells or blood vessels in normal tissue. It is believed that activation of     the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the     activity, safety and CNS exposure of G-202 in patients with PSMA-positive recurrent or     progressive GMB receiving G-202 by intravenous infusion on three consecutive days of a 28-day     cycle.   "
31305|NCT02875990|"     Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of     cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are     associated with immunosuppression and lack of T cell response Such mechanisms would promote     progression to cancer and progression of it . Various factors such as an increase of     regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling     pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms.     At this stage of knowledge, a better characterization of local and systemic immunosuppressive     signing of cervical cancer is needed. The results should have a significant medical impact     for the identification of new prognostic markers and new therapeutic targets for the     treatment of patients with cervical cancer.      The aim of this research project is to define the signing of immunosuppressive cancer cervix     and analyze the different mechanisms involved in this immunosuppression.   "
31306|NCT02875977|"     The investigators intend to measure compliance with attending pelvic floor physical therapy     (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute     educational video or reading a handout explaining the therapy.   "
31307|NCT02875964|"     Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions     implied in epileptic discharges and in normal function.      The current practice in most cases is to implant intracerebral electrodes in order to     localize these regions in a reliable manner. However, non-invasive methods have been     developed in order to record brain activity with no risk for the patient.      Still, it is necessary to validate and improve the signal processing methods and the     underlying models these methods in order to optimize their use in clinical practice. To do     so, it is necessary to record simultaneously electroencephalogram (EEG) and     magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous     recordings will permit to confront the exact same activity recorded non-invasively at the     surface of the head, and represented on the brain thanks to the model and directly within the     brain.      The objective is to define the conditions under which one can represent faithfully the     activity measured intracerebrally from the surface measurements.      It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60     patients. It will be record resting state signals, as well as stimulation protocols. The     interictal epileptic discharges will be marked on the different modalities, and evoked     potentials/fields computed in response to protocols. Sensitivity of recordings to activity     visible on depth recordings will be evaluated as a function of localization of brain     generators. Advanced signal processing methods will be used such as source localization and     independent component analysis, in order to increase sensitivity of measures.   "
31308|NCT02875951|"     A prospective, non-interventional, non-controlled multicenter observational study to evaluate     aspects of pharmaceutical care and the treatment of postmenopausal patients with     hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with     everolimus and exemestane.      The main objective of the study is to evaluate medication adherence in postmenopausal,     hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a     combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy,     with focus on the patient perspective, will be investigated:        -  Patient satisfaction with treatment information        -  Patient satisfaction with treatment        -  Health-related quality of life        -  Treatment efficacy        -  Treatment-related toxicity        -  Patient follow-up by the oncologic team/general practitioner and or specialized home          nurses      This study should reveal information necessary for the development of pharmacotherapeutic     care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug     over a long period.   "
31310|NCT02875925|"     This is a non-randomized, prospective, quasi-experimental study designed to assess the impact     of pharmacist-provided medication management on total cost of care and clinical outcomes (ie,     hospitalizations, emergency department visits) in a real-world clinical practice.   "
33077|NCT02852811|"     The aim of the study is to investigate if group education about the topic menopause to women     in PHC can improve women's menopausal symptoms and reduce depression.   "
31316|NCT02875847|"     The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A     total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria     will be included. The participants will be randomized into one of three groups consuming     either HMO (two groups) or placebo (one group).      The primary objective of the study is to establish the effect of HMOs on the faecal     microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal     symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and     depression.   "
31317|NCT02875834|"     To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once     daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having     achieved normokalemia following two days of initial ZS therapy (10g TID).   "
31318|NCT02875821|"     In this study, the investigators investigate beneficial effects of ipragliflozin, newly     developted SGLT2 inhibitor, on reduction in visceral fat area and degree of fatty liver in     subjects with T2DM when added to metformin and pioglitazone therapy.   "
31319|NCT02875808|"     The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal     infection in neurosurgical patients with an external ventricular drainage is evaluated.   "
31320|NCT02875795|"     The hypothesis of the present study is that an automatic assessment technic can measure the     impact of the speech disorders on the communication abilities giving a severity index of     speech in patients treated for head and neck and particularly for oral and pharyngeal cancer.   "
31321|NCT02875782|"     The study is a randomized controlled trial (RCT) on a tailored smoking cessation intervention     targeted type 2 diabetic patients who smoke (DM intervention). The objectives are:        1. to study the effectiveness of the DM intervention in achieving (a) smoking cessation,          (b) smoking reduction, and (c) progress to a higher stage of readiness to quit;        2. the changes in levels of HbA1c between (a) the intervention group and the controls, and          (b) quitters and continuing smokers;        3. the predictive factors for the success of the outcomes above.   "
31322|NCT02875769|"     The aim of this randomized, single blinded clinical trial was to evaluate the effect of a     pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and     sodium fluoride (F) in the reduction of viable bacteria in oral aerosol/splatter after a     dental prophylaxis with ultrasonic scaler.   "
31323|NCT02875756|"     The investigators plan to evaluate the effect of the number of needle revolutions inside the     node on the diagnostic yield of endobronchial ultrasound-guided transbronchial needle     aspiration (EBUS-TBNA) in patients with sarcoidosis.   "
31324|NCT02875743|"     Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients     undergoing intensive chemotherapy or transplantation.      This current study aims to assess the impact of prophylactically using the broad-spectrum     anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic     anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia,     and allogeneic stem cell transplantation.   "
31325|NCT02875730|"     This is a prospective trial investigating the effectiveness of a modified MRI preparatory     pulse sequence to improve pulmonary vein isolation visualization.   "
31326|NCT02875717|"     Retrospective Analysis of patients that received shockwave lithotripsy as Treatment of     ureteral or kidney Stones. Condition examinated is the effect of low molecular weight     Heparins and acetylsalicylic acid on the Formation of renal hematoma after shockwave     lithotripsy. Primary outcome is documented hematoma in a postoperative ultrasound control.     Secondary outcomes are perioperative complication, Need for erythrocyte tranfusion,     interventions for bleeding control, readmission or death within 30 days.   "
31327|NCT02875704|"     In this study, markers of oxidative stress will be measured in the aqueous humour of     stargardt disease, age related macular degeneration and diabetic retinopathy patients     compared to controls.   "
31328|NCT02875691|"     This randomized double blind clinical trial performed on 68 patients (32 in intervention and     36 in control group) diagnosed with SLE. The patients in intervention group were given daily     dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of     two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg     of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some     biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline and     end of the study.      The investigators used SLEDAI (systemic lupus erythematous disease activity index )     questionnaire for evaluating the clinical signs of the disease. The questionnaires filled out     at baseline and after 3 month.   "
31329|NCT02875678|"     A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient     Volume Tolerance in Patients with Functional Dyspepsia.   "
31330|NCT02875665|"     This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the     treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in     older people living at home or in a Care Home. It will determine patient acceptability,     tolerability and usability of the T-2 gekoTM device for FI by assessing:        1. device user factors: acceptability of use, ease of device placement, ease of device          interface control and understanding of device instructions;        2. tolerability of device: skin tolerability.   "
31331|NCT02875652|"     Quantification and follow-up during 3 years of circulating tumoral DNA in patients with     choroidal melanoma   "
31332|NCT02875639|"     The main purpose of this research is to reveal the curative effect mechanism of Yiqihuoxue     prescription which treat the disease of qi deficiency and blood stasis. And at the same time     this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of     coronary heart disease (CHD) heart failure the curative effect and security.   "
31333|NCT02875626|"     This is a single-center prospective study evaluating the diagnostic performance and safety of     Infracyanine in women with early breast cancer whose the research of sentinel node(s)     combines isotopes and Infracyanine.   "
31334|NCT02875613|"     The purpose of this study is to determine whether avelumab, an investigational antibody     against programmed death-ligand (PD-L1), has an effect on recurrent nasopharyngeal cancer.     Avelumab is designed to block the interaction between programmed cell death protein 1 (PD-1),     a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be     stimulated, allowing it to more effectively recognize and attack the cancer.   "
31337|NCT02875574|"     The 'rising tide' of antimicrobial resistance is a source of concern across most infectious     diseases. In the UK, for example, 6.8% of the ~8,500 tuberculosis patients seen in 2012 were     resistant to the cheap and effective first-line drug isoniazid. It is of great importance to     prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance     by treating such patients as well as possible.      Currently, guidance on the best treatments for isoniazid resistant tuberculosis is     inconsistent globally. Data from randomised controlled trials, the peak quality of evidence,     is sparse. It is thus important that studies using pre-existing observational data are     undertaken.      The investigators aim to use data and samples collected from Public Health England and     National Health Service hospitals to determine a) the best treatments for patients with     isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug     resistance in the infecting bacteria influence a) (nested case-control study). Eligible     participants will have had isoniazid resistant tuberculosis (without associated rifampicin     resistance) in England between 2009 and 2013 and will have been notified to Public Health     England. The study will be conducted at University College London, National Health Service     hospitals and Public Health England and will last until December 2017. Patient hospital     records and disease surveillance records will be accessed and cultured bacteria from     previously stored samples sequenced.   "
31338|NCT02875561|"     The primary objective of this study is to evaluate the incidence of vulva dysplasia     recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or     ultrasonic aspiration.   "
31339|NCT02875548|"     This study will provide continuing availability to tazemetostat as a single agent to subjects     who have completed their participation in an antecedent tazemetostat study (either with     monotherapy or combination therapy). In addition, long-term safety and overall survival will     be collected.   "
31340|NCT02875535|"     Reducing youth suicide in the U.S. is a national public health priority. Sexual and gender     minority adolescents are at elevated risk for suicide. Safer school environments, however,     can decrease this risk. This study capitalizes on the critical role of school nurses in     improving the mental health of this vulnerable population through implementation and     sustainment of evidence-based strategies to enhance school environments. In addition to     suicide, the conceptual framework and methods for this novel, nurse-led intervention can be     applied to address the health-related concerns of other pediatric populations encountered in     school settings as well.   "
31341|NCT02875522|"     The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to     inflammation in the lungs and blood vessels that can lead to secondary problems such as blood     vessel disease, high blood pressure and heart disease. Aerobic exercise training has been     shown to reduce the risk of heart and brain disease; however, it is currently unknown whether     exercise training can have the same affect in patients with COPD. The aim of this study is to     investigate how eight weeks of aerobic exercise training improves blood vessel and heart     function and brain blood flow in patients with COPD.   "
31342|NCT02875509|"     One hundred patients, aged from 41 to 78 years, underwent open heart surgery in the years     1998-1999 and were studied by using the Cellstick device for harvesting wound inflammatory     cells during the first 24 hours after surgery. The results of the differential count were     computerized by using artificial neural network for obtaining wound inflammatory cell node     (WICN). The patients were followed up for sixteen years or to the death. WICN values were     compared with the patients´ survival.   "
31343|NCT02875496|"     Establishment of a BNA reference database for the Adult and Elderly Population.     Hypothesis-generating study designed to collect data that will aid in future scientific and     engineering exploration of correlations between clinical assessments and BNA scores. The     results are primarily intended for scientific inquiry and engineering development purposes,     and may be used in future regulatory submissions.   "
31367|NCT02875184|"     This is a multicenter, prospective, non-interventional, observational single arm study.      Two-hundred patients will be recruited in the Netherlands over a one year period. In all     cases, the decision to treat the patient with apremilast will be made prior to the decision     to enter the subject into this study. Treatment will be according to routine clinical     practice and based on recommendations as per the Summary of Product Characteristics (SPC) of     apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.   "
31344|NCT02875483|"     Over 50% of all pregnancies that occur in the US are unintended, and unintended pregnancy is     detrimental to maternal and child health. Tubal sterilization may be performed immediately     following a delivery, or as an interval procedure remote from pregnancy. Many women request     sterilization to follow delivery, but it is frequently not completed during the peri-partum     hospitalization. Women who are denied an immediate post-partum tubal are generally candidates     to complete the procedure as an interval surgery within a few months of delivery, but few do     so. Women who request tubal sterilization and do not receive it are at highest risk for a     rapid repeat pregnancy, with as many as 46% having an unintended pregnancy within 1 year.      The standard care at many institutions for a patient denied tubal sterilization during     hospitalization is to offer a short term contraceptive and instruct the patient to follow up     for the standard post-partum outpatient visit in 4-6 weeks. If the patient still desires     tubal sterilization at that time, the surgical procedure will be scheduled. No-show rates for     post-partum care are high at about 50%-60%, and therefore, many patients are never scheduled     for their surgery. If the process of scheduling interval tubal sterilization surgery could be     expedited, rates of completion could be improved.   "
31345|NCT02875470|"     This study compares the efficacy of diamond burs and Gracey curettes in non-surgical     periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical     parameters and scanning electron microscopic investigations on root surfaces. Two quadrants     of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were     treated with Gracey curettes. Also 21 hopeless teeth received root planing either with     diamond burs or curettes or no treatment at all and were then extracted for microscopic     evaluations.   "
31397|NCT02874794|"     To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic     characteristic impedance compared to enalapril in patients with heart failure and reduced     ejection fraction (left ventricular ejection fraction [LVEF] ≤ 40%) after 12 weeks of     treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ     in early systole) between baseline and Week 12.   "
31346|NCT02875457|"     Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several     phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and     other tumors also showed apatinib has less toxic side effects and better patient tolerance.     However, the clinical application of apatinib in small cell lung cancer is still lack of     evidence-based medicine. Etoposide and cisplatin chemotherapy is the first-line treatment for     small-cell lung cancer. The purpose of this multicenter, randomized, prospective study is to     investigate the efficacy and safety of apatinib as the maintenance therapy for extensive     stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.   "
31347|NCT02875444|"     Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk     of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's     treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of     45-50 mm in women.      The importance of this measure for patient management justify a specific and homogeneous     protocol of measure. However, the diversity of methods of measuring the maximum diameter with     scanner and ultrasound was shown.      The impact of various angio-CT based measures of maximum AAA diameter, and the impact of     reproducibility limits on the decision to operate have never been investigated.   "
31348|NCT02875431|"     Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy     and fusion   "
31349|NCT02875418|"     Background:      Identification and measurement of uterine contractions throughout pregnancy and labor is     crucial to the well being of both mother and fetus. Prematurity is one of the major causes     for adverse pregnancy outcomes, and clinical decision-making often relies on uterine     frequency as recorded by a tocodynamometer, as well as on other methods including sonographic     cervical length, pelvic examination.      Objective:      To show that the use of the EUM in preterm labor is effective in establishing true preterm     labor.   "
31350|NCT02875405|"     The purpose of this study is to determine if preforming a posterior left pericardiotomy     prevents atrial fibrillation after cardiac surgery.   "
31351|NCT02875392|"     Studies reveal special function of fucoidan so far include anti-virus, anti-tumor,     immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney     dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on     the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.   "
31352|NCT02875379|"     Background. Non invasive positive pressure ventilation (NIV) is among first line treatments     of acute respiratory failure. Several interfaces are available for non-invasive     ventilation.Despite full face and oronasal masks are more frequently used, some evidence     suggests that helmets may optimize patients' comfort and NIV tolerability.      During NIV, humidification strategies (heat and moisture exchangers HME or heated humidifiers     HH) may significantly affect patient's comfort and work of breathing.      Despite physiological data suggested heated humidification as the best strategy during NIV     with full face masks, no differences were found in a randomized controlled study assessing     the effects of HME or HH on a pragmatic clinical outcome.      However, the higher dead space (i.e. 18 L/min) and rebreathing rate observed during helmet     NIV make such results not applicable to this particular setting.      The investigators designed a randomized-crossover trial to assess the effect of four     humidification strategies during helmet NIV on patients with acute respiratory failure, in     terms of comfort, work of breathing and patient-ventilator interaction.      Methods. All awake, collaborative, hypoxemic patients requiring mechanical ventilation will     be considered for the enrollment. Hypercapnic patients (i.e.PaCO2>45 mmHg) will be excluded.      Each enrolled patient will undergo helmet NIV with all the following humidification     strategies in a random order. Each period will last 60 minutes.        -  Passive humidification, double tube circuit.        -  Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification          chamber temperature 33°C.        -  Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification          chamber temperature 37°C.        -  Passive humidification with HME, Y-piece circuit.      Ventilatory settings (Draeger Evita xl or Evita infinity ventilators):      Pressure support ventilation; pressure support=20 cmH20; FiO2 titrated to obtain SpO2 between     92 and 98%; positive end-expiratory pressure=10 cmH2O; maximum inspiratory time 0.9 seconds;     inspiratory flow trigger = 2 l/min; expiratory trigger: 30% of the maximum inspiratory flow;     pressurization time=0,00 s.      Such settings will be kept unchanged during the whole study period. An oesophageal catheter     will be placed and secured to measure oesophageal pressure (Pes) and gastric pressure (Pga)     (Nutrivent, Italy): the reliability of the measured pressure will be confirmed with an airway     occlusion test during NIV with oronasal mask. Work of breathing will be estimated with the     pressure-time product (PTP) of the pleural pressure.      A pneumotachograph (KleisTek) will record flow, airway pressure, Pes and Pga on a dedicated     laptop.      At the end of each cycle, the patient will be asked to rate his/her discomfort on a visual     analog scale (VAS) modified for ICU patients. The level of dyspnea will be assessed with the     Borg dyspnea scale.      The following parameters will be record at the end of each cycle:      Arterial pressure, heart rate, respiratory rate, SpO2, pH, PCO2, PaO2, SaO2. Airway and     esophageal pressure signals will be reviewed offline to detect patient-ventilator     asynchronies (ineffective efforts, double cycling, premature cycling, delayed cycling) and     asynchrony index (number of asynchrony events divided by the total respiratory rate computed     as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts) will     be computed. The trigger delay will be also measured. The pressurization and depressurization     velocity will be assessed with the PTP airway index 300 and 500 (inspiratory and expiratory),     as suggested by Ferrone and coworkers. The work of breathing (WOB) for each breath will be     estimated by PTPes.      An hygrometer (Dimar SRL, Italy) will measure and record on a dedicated laptop Helmet     temperature, relative and absolute humidity.      Primary endpoints: patient's comfort, work of breathing and asynchrony index.      Sample Sizing:      Given the physiological design of the study, the investigators did not make an a priori     sample size and plan to enroll 24 patients.   "
31353|NCT02875366|"     This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in     subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.     This study is designed to evaluate the effect of LUM/IVA on manifestations of CF affected by     exercise tolerance & training.   "
31354|NCT02875353|"     The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates     of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in     PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for     prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet     drugs or with large ulcers) after snare resection of benign colon polyps.   "
31355|NCT02875340|"     The objectives of this study are to assess the safety, tolerability, pharmacokinetics and     efficacy of VAL401 in the treatment of patients with locally advanced or metastatic non-small     cell lung adenocarcinoma.   "
31366|NCT02875197|"     The purpose of this research is to provide clinically, administratively, and field-relevant     objective running outcomes by directly comparing running biomechanics of individuals with     lower extremity amputation (ILEA) using RSPs (Running Specific Prostheses) and traditional     prostheses. Within this purpose, the project has two specific aims:      Specific Aim 1: To compare RSPs and traditional prostheses with respect to running ability     and performance      Specific Aim 2: To compare RSPs and traditional prostheses with respect to injury risks     associated with running      Hypothesis 1a: RSPs will outperform traditional prostheses at all velocities as measured by     kinetic data (ground reaction forces, joint powers, joint and limb work) and 50m dash time.      Hypothesis 1b: ILEA intact limbs and able-bodied control limbs will outperform residual limbs     with RSPs and traditional prostheses at all velocities as measured by kinetic data.      Hypothesis 2: Running with RSPs will show reduced acute and chronic injury risks compared to     traditional prostheses at all velocities as measured by loading rates, EMG amplitudes,     lumbopelvic kinematics, and modeled joint loads.   "
31413|NCT02874586|"     An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination     of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).   "
31356|NCT02875327|"     Background:      The SEER database collects data about people with cancer. SEER stands for Surveillance,     Epidemiology, and End Results. Medicaid is a kind of health insurance. It is for people who     have low income or serious medical needs. Many studies have shown that Medicaid recipients     with cancer are more likely to be diagnosed later in the disease than people with other     insurance. They are also less likely to get treatment. Researchers want to compare Medicaid     data and SEER data. They want to make this available to other scientists.      Objectives:      To link people in the SEER database to Medicaid data for the years around their cancer     diagnosis. To create a file that contains SEER case numbers linked to Medicaid numbers.      Eligibility:      No people are enrolled in this study.      Design:      The SEER finder file will be securely uploaded to the CMS Data Center.      The finder file will be matched against the Medicaid Personal Summary file at the CMS Data     Center.      If participants appear in both the SEER file and Medicaid file, their data will be extracted.      The dates of Medicaid data will be compared with the SEER date of diagnosis. Researchers will     see if the Medicaid dates fall in certain periods. These are 12 months before, the month of,     and 11 months after diagnosis.      If participants are eligible for Medicaid for these periods, a flag will be created in the     file. It will note the participants is eligible and why.      The SEER finder file will be destroyed.      The only data saved will be:      Each participant's unique random SEER case number linked to their Medicaid number      Monthly flags about Medicaid eligibility   "
31398|NCT02874781|"     This study measures the sublingual microcirculation of patients with kidney transplant using     MicroScan. The data will be compared with data of health volunteers and end stage renal     disease patients on hemodialysis.   "
31357|NCT02875314|"     This is a prospective randomized clinical trial, to determine whether dose-intensive tandem     Consolidation, in a randomized comparison with single cycle Consolidation, provides an     event-free survival (EFS) and overall survival (OS). The study population will be high-risk     patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with     central nervous system (CNS) embryonal tumors completing Head Start 4 Induction. This study     will further determine whether the additional labor intensity (duration of hospitalizations     and short-term and long-term morbidities) associated with the tandem treatment is justified     by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation     regimen will produce a superior outcome compared to the single cycle Consolidation, given the     substantially higher dose intensity of the tandem regimen, without significant addition of     either short-term or long-term morbidities.   "
31359|NCT02875288|"     Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine     compared to liposomal bupivacaine in patients undergoing elective, minimally invasive,     general surgery procedures. To the investigators knowledge, there are no head-to-head,     prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine     to evaluate postoperative pain and return of function.   "
31360|NCT02875275|"     This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3     possible test meals (Grass Jelly). The participants will have the option to voluntarily     choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese     male subjects from the general public over a period of one year.   "
31361|NCT02875262|"     Aneurysmal subarachnoid hemorrhage (SAH) is a form of stroke in which secondary neurological     deterioration is an important cause of mortality and morbidity. These secondary changes, so     called delayed cerebral ischemia (DCI), are caused by lysis of erythrocytes which can react     to form iron, an toxic substance to the brain. Iron chelators remove the excess of iron and     are standard care in iron-overloaded patients. Deferoxamine (DFO) an chelator has not been     evaluated in SAH patients. This study evaluates the safety of deferoxamine in SAH patients   "
31362|NCT02875249|"     Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for     haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects,     with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI     mucositis pathophysiology are generally silent on the role of the intestinal microbiome.      The aim of the study is to identify functional mechanisms by which the intestinal microbiome     may play a key role in the pathophysiology of GI mucositis, the investigators applied high     throughput DNA-sequencing analysis to identify microbes and microbial functions that are     modulated following chemotherapy.   "
31363|NCT02875236|"     Efficacy and safety of octaplasLG® administration vs. crystalloids (standard) in patients     with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial.   "
31365|NCT02875210|"     Actually, there are several laximeters for measuring anterior tibial translational in case of     anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and     Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters     values), have a bad correlation between them and so are not comparable in current literature.     The aim of this study was to compare results of these tests and establish a ratio (pathologic     knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.   "
31491|NCT02873572|"     Addictions without substances are an emergent problem giving rise to a recent and increasing     request of care. Among these new addictions, pathological gambling and pathological online     video gaming which are up. The purpose of this study is to identify vulnerability factors     (personality traits, decision making strategies...), which are common or specific to each     type of game (on line poker, casino, MMORPG, and no-gamers).   "
31368|NCT02875171|"     Anthracycline therapy is well-known for its adverse cardiac effects. Anthracycline-induced     cardiotoxicity (AIC) is associated with a poor prognosis; since classical heart failure     treatment can potentially reverse cardiac dysfunction at the early stage of cardiac toxicity,     early detection of AIC is crucial.      Transthoracic echocardiography is recommended for monitoring left ventricular function in     patients receiving these molecules. In routine practice, left ventricular systolic function     is mainly assessed by the left ventricular ejection fraction (LVEF), measured by     two-dimensional echocardiography imaging. However, LVEF depends on the operator's experience     and is not sensitive enough to detect subclinical myocardial dysfunction.      To overcome these limitations, two-dimensional speckle-tracking imaging has been proposed.     This technique allows for a study of global and regional myocardial deformation, especially     the longitudinal component, which appears to be the most sensitive one. Several studies have     already emphasized the role of global longitudinal strain (GLS) to detect slight alterations     in systolic function, especially in the setting of potentially cardiotoxic drugs and even     after low to moderate doses of anthracyclines. A recent expert consensus paper strongly     recommends GLS assessment for the detection of subclinical left ventricular dysfunction due     to anthracycline therapy.      Although there is growing evidence that GLS can predict subsequent alterations in LVEF, few     data exist on the optimal timing to perform echocardiography.      The investigators hypothesized that very early measurement of GLS in the time course of     anthracycline therapy could predict subsequent left ventricular systolic dysfunction.      The aim of this study was, therefore, to determine whether assessment of GLS after 150 mg/m²     of anthracyclines can predict AIC.   "
31369|NCT02875158|"     Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce     intraocular pressure in case of glaucoma. Due to concerns over complications, the main     indications for this second-line treatment are refractory glaucoma medication / surgery and     low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the     majority of researchers and clinicians according to the published literature. Some have     proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.      The aim of this study is to determine how different parameters affect the efficacy of the     treatment. This is a prospective double-blinded randomized controlled trial comparing two     groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000     mW for 2 seconds.   "
31370|NCT02875145|"     The follow up time after keratoplasty now routinely exceeds multiple decades. It is common     for keratoplasty patients to also undergo cataract surgery at a later date in their lives.      Keratoplasties and cataract surgery both result in local inflammation. This may influence the     density of endothelial cells, and on average there is a loss of 10% in endothelial cells     within 3 months of the cataract surgery. Yet, a sufficient density of endothelial cells is     required to maintain graft transparency. It may be therefore difficult to strike a balance     between loss of visual acuity due to the cataract of to the loss of graft transparency over     the long term.      The investigators aim to compare graft survival in patients with clear crystalline lens with     and without cataract surgery.   "
31372|NCT02875119|"     This is a two-part study. The first part is a single-dose open label design. The second part     employs a multiple dose, randomized, placebo controlled study design. Studies have     demonstrated that GRFT is highly potent for HIV prevention and is effective at very low     concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal     concentration of GRFT for the prevention of HIV, based on preclinical data, will be     evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be     minimally absorbed systemically, if at all.   "
31373|NCT02875106|"     The primary objective in this study is to identify commercial pulse detection systems (CPDS)     parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able     to detect atrial fibrillation or sinus rhythm of screened patients.   "
31374|NCT02875093|"     Assessment of safety and tolerability of drug combination and determine time on treatment,     Overall survival (OS) and response rate with patient disease burden, and type of disease   "
31375|NCT02875080|"     The ratios of the geometric means of the ODT formulation to those of the reference     formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of     brexpiprazole (OPC-34712)).   "
31376|NCT02875067|"     This trial is to assess the safety & efficacy of the Combination of Pembrolizumab and     Lenalidomide in the management of patients with Relapsed Hodgkin Lymphoma.   "
31377|NCT02875054|"     Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as     compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP)     following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and     hand-arm bimanual intensive training (HABIT).   "
31378|NCT02875041|"     This is a feasibility and exploratory pilot study of adjuvant transcranial magnetic     stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in     Parkinson's disease patients.   "
31379|NCT02875028|"     Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet     inhibition may also exert positive results on coagulation activation and may beneficially     influence the inflammatory response. Since vorapaxar is the first available substance of a     new class of platelet inhibitors its effects on the human coagulation system and the     inflammatory response will be assessed in the well-established human endotoxemia model.   "
31380|NCT02875015|"     Postoperative pain, the quality of their recovery and the opioid consumption following a     midurethral sling placement are being compared between 2 groups. One group will have the     hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group     will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine     solution.   "
31381|NCT02875002|"     This phase 1, multicenter, open-label study is designed to find the RP2D of volasertib, a     PLK1 inhibitor, and belinostat, an HDAC inhibitor, when given in combination to patients with     relapsed or refractory B-cell or T-cell lymphoma. A standard 3+3 dose-escalation design will     be employed with study enrollment beginning at dose level 1.   "
31382|NCT02874989|"     The purpose of this study is to determine whether dasatinib and quercetin can reduce the     expression of pro-inflammatory cells obtained by skin biopsy.   "
31383|NCT02874976|"     Interventional   "
31384|NCT02874963|"     This intervention study is designed to evaluate the effects of non-surgical procedure in     addition to surgical procedure on systemic inflammation and glycemic control in with type 2     diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic     patients.   "
31385|NCT02874950|"     Background:Musculoskeletal discomforts (MSD), especially in the neck, lower back and shoulder     areas, are some of the most common issues among office workers. The Social Security     Organization (SOCSO) in Malaysia caps number of cases involving musculoskeletal injuries at a     maximum of 10,000 per year.      Objectives: The primary aims of this research were to: 1. Measure the prevalence of MSD in a     sample of office workers; 2. Test effective methods of reducing lower back, neck and shoulder     pain in this sample by training exercise, or ergonomics modification, or both of them; and 3.     Assess discomfort scores and the range of motion of the lower back, neck and shoulder muscles     among the office workers after undertaking the different methods for a period of 6 months.      Methods: In a true experimental design, from 10,000 staff in Telecom Malaysia,onehundred and     forty two office workers (of whom 50 were male), aged 20-50 y, were allocated randomly, from     3 different locations (Bangsar, Puchung, and Damansara), to one of three intervention groups     (receiving training exercise, receiving modified ergonomics, receiving a combination of     exercise and ergonomics modification) and a control group (receiving none of these     interventions). The Cornell MSD Questionnaire was used to measure musculoskeletal     discomforts, with focus on pain severity, before treatment and after 2, 4 and 6 months of the     interventions. The range of motion (ROM) of the hip, neck, shoulder and knee were measured by     a 12 inch goniometer, and the Borg CR10 scale was used to measure the perceived exertion of     training exercises. The rapid office strain assessment (ROSA) questionnaire was used to     assess the strain associated with office work. Height and weight were also measured to     calculate the body mass index (BMI).   "
31386|NCT02874937|"     Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and     probably is responsible for CDN $250 million in health care spending each year.There is no     known medical treatment for frequent fainting. Two randomized studies suggest that inhibition     of norepinephrine transport (NET) reuptake with sibutramine and reboxetine (NET inhibitors)     prevents syncope on tilt testing by about 80%, and the investigators reported that     sibutramine markedly reduced the frequency of vasovagal syncope in 7 of our most symptomatic     patients. Sibutramine and reboxetine, for different reasons, are not available in Canada.     However atomoxetine is available and is used to help patients with attention deficit     disorder. There are no data pertaining to its hemodynamic effects in patients with vasovagal     syncope. Although a randomized clinical trial of atomoxetine for the prevention of vasovagal     syncope would be needed before clinical use, the investigators first need a proof of     principle study. The objective is to determine in a prospective, randomized, parallel,     double-blind study if atomoxetine 40 mg bid in patients at least 18 years old with recurrent     vasovagal syncope will better prevent syncope during tilt testing than placebo.   "
37008|NCT02801292|"     The primary objective of the proposed study is to determine the potential role of Ketamine as     an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in     acute (VOC).   "
31387|NCT02874924|"     The ability to mount an effective immune response declines with age, leaving the elderly     increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug     to prevent transplant rejection, increases the lifespan and healthspan of mice and     ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in     laboratory animals. Investigators are conducting a translational trial to test whether     rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95).   "
31388|NCT02874911|"     Exergame training might offer a novel treatment approach even in largely nonambulatory     subjects with multisystemic degenerative spinocerebellar ataxia.   "
31389|NCT02874898|"     This study examines how marijuana use affects processes related to recovery from chronic     posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic     PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana     use. This study will assess how individuals with PTSD with heavy or no marijuana use perform     on a discriminative conditioning and extinction paradigm designed to measure fear extinction     learning, and how they respond to a brief daily imaginal exposure treatment in regards to     PTSD symptom reduction.   "
31390|NCT02874885|"     Objectives:        -  To establish the rate of circulating tumor cells (CTC) positivity in patients with          locally-advanced rectal cancer (LARC), relative to other stages;        -  To assess changes in detected CTCs associated with neoadjuvant therapy in patients with          LARC;        -  To correlate CTC counts with neoadjuvant treatment response as an indicator of disease          risk.   "
31391|NCT02874872|"     The OASIS Collaborative is an organizational intervention aimed at reducing unnecessary     antibiotic use in skilled nursing facilities. The first target of intervention is the tasks     carried out by nursing staff after a change in condition and after an antibiotic prescription     is initiated. The second target are the management staff who provide feedback to staff. The     third target are the administrators who identify and overcome organizational barriers to     implementation.      In this study, we will implement two tools that are intended to minimize unnecessary     antibiotic use in skilled nursing facilities. The first tool helps skilled nursing facility     staff assess risk and communicate with prescribers when residents experience a change in     health status that may result in the use of antibiotics. The second tool is used after an     antibiotic is prescribed; the tool streamlines reassessment of the patient, and provides     prescribers the opportunity to consider stopping unnecessary antibiotic prescriptions,     narrowing the spectrum of antibiotic therapy, or shortening the duration of antibiotic     therapy.   "
31392|NCT02874859|"     This a non-interventional retrospective study on the efficiency and the tolerance of     intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema   "
31393|NCT02874846|"     To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal     Intraocular Pressure.   "
31394|NCT02874833|"     A randomized single-blinded prospective study to evaluate the efficacy of an individualized     supervised 8-week exercise program in subjects with moderate to severe depressive episodes     compared to treatment-as-usual   "
31443|NCT02874196|"     The purpose is to determine diagnostic performances of flat panel dual energy arthrography     and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as     reference the results of surgery performed 6 months after arthrography.      Secondary purposes are:        -  To describe the level of concordance of each technique with the indication for surgery        -  To study inter-technique concordance with kappa coefficient        -  To study the relationship between density differential between 2 acquisitions and grey          level on subtraction, i.e. subtraction quality according to metal   "
31395|NCT02874820|"     The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the     numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric     conditions such as depression and addiction, along with neurodegenerative disorders such as     Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated     functional interactions with the opioid system, where I2BS ligands have been shown to affect     tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats.     Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects     in different models of pain.      The location of I2BS on astrocytic glial cells and the possibility that they may in some way     regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS     and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been     shown to increase in Alzheimer's disease post mortem, and it has also been suggested that     I2BS may be a marker for the severity and malignancy of human glioblastomas.      The lack of suitable imaging tools for the I2BS has meant that information regarding the     number and distribution of I2BS in the brain has come from preclinical species and in vitro     post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to     quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional     distribution in the living human brain. In this study the investigators plan to utilise     [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo     using PET.   "
31396|NCT02874807|"     Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of     antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water     retention and secondary natriuresis and is a common cause for hyponatremia.      The therapeutic options, aside from treating the underlying disease, depend upon the onset     and severity of the symptoms and involve usually fluid restriction or hypertonic saline     infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or     vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable     number of patients which do not sufficiently respond, making additional therapy necessary.      Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a     new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is     expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered     glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent     osmotic diuresis. This mechanism could result in a therapeutic effect in patients with     hypotonic hyponatremia as in SIADH.      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the     serum sodium levels of patients with SIADH.   "
31399|NCT02874768|"     This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will     be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group.     In the dexmedetomidine group, patients will receive continuous intravenous infusion of     dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h). In the propofol group, patients     will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6     mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with     chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data     such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be     recorded. The microcirculation will be examined by Cytocam. The following microcirculatory     parameters will be investigated: total small vessel density, perfused small vessel density,     microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays     will be used to measure serum level of endocan, diamine oxidase, and neutrophil     gelatinase-associated lipocalin at preset time points. The primary goal of this study is to     compare the effect on microcirculation between dexmedetomidine and propofol in intensive care     unit patients after abdominal surgery.   "
31400|NCT02874755|"     The purpose of this study is to evaluate the impact of the Private Provider Interface Agency     (PPIA) program on quality of care. The PPIA is a tuberculosis pilot program implemented in     the private health sector of Mumbai city, India.   "
31401|NCT02874742|"     The purpose of this study is to determine if the addition of daratumumab to     lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants     achieving stringent complete response (sCR), as defined by the International Myeloma Working     Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation     (ASCT) consolidation treatment, compared with RVd alone.   "
31402|NCT02874729|"     Tumour biomarkers are substances produced by cancer or by other cells of the body in response     to cancer conditions. They are used to help detect, diagnose, manage and predict outcome or     recurrence of some types of cancer. Tumour biomarkers can also help doctors choose the most     appropriate therapy or judge if treatment is successful. Several tumour biomarkers are     already used in the clinic; however, many others do not meet rigorous scientific standards to     enter into clinical practice and some solid cancers can be only detected using tissue biopsy,     a rather invasive procedure. Likewise, evaluating efficacy of novel therapies during clinical     trials relies on adequate and specific laboratory tests. Therefore novel biomarkers and novel     methods, to measure them, still represent an un-met clinical need.      This study aims to develop innovative, more sensitive and reliable tests for better targets,     in order to assess and monitor circulating cancer biomarkers. Easily accessible samples, like     blood, will be tested such that invasive tissue biopsies can be avoided. Both healthy     individuals and cancer patients will be recruited in this study to establish if a laboratory     test is powerful enough to distinguish between individuals that may have cancer or not.     Participants' involvement will also support development of novel tests to decide if a novel     therapy is efficiently counteracting cancer growth or not.      Participants in the study will be asked to donate blood, sputum, urine or other body fluids,     depending on the cancer and the assay being developed. After participants give their informed     consent, the researchers will isolate cells, soluble factors or nucleic acids from body     fluids. Researchers will then use various laboratory techniques to screen cells, soluble     factors or nucleic acids for specific markers. This study looks at the effectiveness of using     laboratory tests to quantify tumour markers in body fluids and, subsequently, to monitor     patients' response to treatments.   "
31403|NCT02874716|"     The purpose of this study is to evaluate the impact of the Private Provider Interface Agency     (PPIA) program on quality of health care. The PPIA is a tuberculosis pilot program     implemented in the private health sector of urban Patna in the state of Bihar, India.   "
31404|NCT02874703|"     In this study, investigators plan to test two potential mechanisms contributing to diastolic     dysfunction among asymptomatic persons with HIV who are on cART. The first proposed mechanism     is that heightened systemic immune activation/inflammation in HIV contributes to myocardial     inflammation, which in turn promotes myocardial fibrosis. The second mechanism is that     ectopic fat deposition (increased visceral adiposity) in HIV relates to increased     intramyocardial lipid content, which in turn contributes to diastolic dysfunction. Both HIV     positive and HIV-negative participants will undergo cardiac MRI/ MRS imaging studies for     evaluation of myocardial fibrosis, myocardial inflammation, and intramyocardial lipid     content. Traditional markers of CVD risk, inflammatory markers/immune, hormonal markers, and     markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS     outcomes.   "
31405|NCT02874690|"     The overall goal of this research is to use neurophysiological measures to profile strengths     and deficits for Attention Deficit Hyperactivity Disorder co-morbidity in Autism Spectrum     Disorder to clarify diagnosis and to predict treatment response.   "
31406|NCT02874677|"     Multiple sclerosis (MS) is a disease affecting the white matter of the central nervous     system. In France, it concerns approximately 80 000 patients and represents one of the most     frequent neurological affections in young adults. Effort deconditioning of people affected by     MS is already proven, but it is not just linked to the disease itself. The decrease of     capacities to produce an effort is aggravated by neurovegetative and cardiovascular     disorders. The limitation or the complete stop of physical activity is often linked to the     fear of a handicap aggravation. Causes of stop are multiple, including fatigue and balance     disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated     by MS are frequent, represent the first symptom of the disease (10 to 20 % of cases) and     alter significantly the quality of life.      Some reeducation programs were proposed in hospitalization with some efficiency on functional     capacities. It is now admitted that physical exercise is not noxious, and allows the     implementation of effort reeducation for MS. Randomized controlled studies have shown in MS     patients an improvement of physical abilities, of O2max (aerobic capacity), of quality of     life and a decrease of fatigue. For MS, only a few studies estimate the effect of effort     reeducation on treadmill. Unfortunately, the efficiency of these programs on walking     endurance are controversial.      During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1)     corresponds to a greater increasing of CO2 compared to O2. The identification of VT1 allows     the precise determination of the limit from which the body is incapable of producing the     necessary energy to realize an effort using the aerobic metabolism. The VT1 is situated at a     level of load with enough intensity for the subject to support the test without dyspnea. A     VT1 lower than 40 % of the theoretical VO2 max is considered as a marker of maladjustment to     effort due to dyspnea and excessive muscular fatigue. This indication is very informative     about the quality of life of patients.      The goal of this study is to apply a personalized reeducation concerning the working load     pre-hyperventilation to deconditioned subjects, easily worried by effort induced     breathlessness and fatigue in order to get the optimization of the aerobic function. The     hypothesis is that reeducation at this level improves the distance of walking and the quality     of life of patients affected by MS.   "
31408|NCT02874651|"     This study will enroll patients with non-metastatic nasopharyngeal carcinoma (NPC) that have     residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. The     purpose is to evaluate the survival in these patients treated with apatinib (YN968D1), an     inhibitor of vascular endothelial growth factor receptor (phase IIa) and to compare the     survival in these patients treated with apatinib versus placebo (phase IIb).   "
31500|NCT02873455|"     Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery. The     investigators aim to evaluate the effect of video information on preoperative anxiety level     in patients with colorectal cancer.   "
31409|NCT02874638|"     Protein requirements in individuals who participate in endurance-based exercise training have     been suggested to be greater than the current recommended dietary allowance (RDA).      The biological value of protein depends on its amino acid composition. Essential amino acids     are believed to have main role on whole body protein metabolism. However, it remains to be     determined what role non-essential amino acids (NEAA) may have in regulating protein     metabolism and contributing to the increased protein requirements after endurance exercise.      The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid     requirement in children, normal healthy adult and clinical populations. However, the IAAO     method has never been utilized for assessing the effect of NEAA on protein requirements after     endurance exercise.      The objective of the current study is to investigate the importance of NEAA for     endurance-trained male subjects.   "
31410|NCT02874625|"     In this randomized clinical trial, the bio-compatibility of 2 materials used for dental     restorations will be compared: glass-ionomer vs resin-based composites.      Urine and saliva samples will be taken for determination of bisphenol A levels at several     time points, and for analysis of the estrogenic activity using ERE-CALUX.      Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit.     Global alterations in DNA methylation and DNA hydroxymethylation levels will be determined     using UPLC-MS/MS.   "
31411|NCT02874612|"     Background: The often studied psychosocial correlates that relate to health outcomes in     adolescents with Type 1 Diabetes (T1D) are factors such as self-efficacy, depression,     distress, quality of life, and adherence. These psychosocial factors are not well-studied     within a young adult (YA) population and the parents of YAs during the transition planning     phase. Impact: This study aids program development for pre-transfer educational interventions     to ensure more successful post-transfer health outcomes from both a patient and parent     perspective. Methods: This longitudinal study is designed to characterize the psychosocial     factors relevant for a population of YA with T1D. Data analyses of these psychosocial and     transition readiness variables allow for understanding of prospective health outcomes for     young adults with T1D during the transition process. Implications/Future Directions: From a     clinical perspective, the outcomes of this feasibility study will be two-fold: (1) establish     which of the clinical measures used in the study are related to meaningful health outcomes in     this young adult population in order to determine future standardized assessments in the     Diabetes Center and (2) determine which psychosocial constructs are relevant to health     outcomes to then more fully develop the Diabetes Center's transition program interventions to     improve functioning clinic-wide (e.g., group day sessions). Finally, it would be attractive     to various National Institutes of Diabetes and Digestive and Kidney Disorder (NIDDK) grant     mechanisms to identify the relevant psychosocial measures that assess the psychosocial     functioning of YA with diabetes after they transfer to adult care.   "
31412|NCT02874599|"     Adult patients who require multiple dental restorations will be included in this study. Urine     and saliva samples will be taken for determination of bisphenol A levels at several time     points, and for analysis of the estrogenic activity using ERE-CALUX.      Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We     will determine global alterations in DNA methylation and DNA hydroxymethylation levels using     UPLC-MS/MS.   "
31414|NCT02874573|"     This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy of     Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with     schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant     humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin     G1 (IgG1) subclass. Tocilizumab is formulated as a concentrate for solution for infusion, and     will be administered by intravenous infusion.      The investigators propose a 12-week randomized controlled trial of tocilizumab, given in     adjunct to antipsychotics, in N=20 stable outpatients with schizophrenia or schizoaffective     disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity     C-reactive protein [hsCRP]>0.5 mg/dL). The investigators hypothesize that adjunctive     treatment with tocilizumab will be associated with significant improvement in cognition     compared to placebo in patients with schizophrenia, and baseline IL-6 levels are higher in     tocilizumab-treated responders versus non-responders, and there will be greater decreases in     hsCRP from baseline to week 12 in tocilizumab-versus placebo-treated responders, with     response defined as ≥0.5 standard deviation (SD) improvement in cognition. Tocilizumab is     administered as an intravenous infusion every 4 weeks. Following a screening evaluation,     participants will receive three infusions of siltuximab, one at baseline, another at week 4     of the study, and another at week 8. The investigators will measure changes in cognitive     function and symptoms over a 12-week period. Complementing previous positive clinical trials     of non-steroidal anti-inflammatory drugs, this would be a proof-of-concept study that     targeting specific cytokines is a viable treatment for schizophrenia.      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by     Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical     development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for     Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002,     respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003.      On 11 January 2010, Tocilizumab was approved by the U.S. Food and Drug Administration (US     FDA) as Actemra for the treatment of rheumatoid arthritis. The FDA approved tocilizumab for     the treatment of systemic juvenile idiopathic arthritis for children from two years of age in     April 2011.   "
31415|NCT02874560|"     In a population of patients suffering from schizophrenia being treated for an episode of     clinical destabilization and followed for a period of twelve months, the main objective is to     evaluate the proportion of patients achieving functional remission and its relationship to     clinical remission.   "
31416|NCT02874547|"     Community Health Workers (CHWs) using patient stories to support hypertension management is a     randomized controlled trial to evaluate the implementation of a CHW-delivered culturally     appropriate storytelling intervention for english and spanish-speaking patients diagnosed     with hypertension who receive care at community health center settings.   "
31417|NCT02874534|"     The overall goal of this project is to develop a novel transdiagnostic treatment for     anhedonia, called Behavioral Activation Treatment for Anhedonia (BATA), using ultra-high     field functional neuroimaging. There is a critical need for a validated treatment that     specifically targets anhedonia, and this project will evaluate the effects of this new     treatment on anhedonia and will establish how this treatment impacts brain systems that     mediate reward processing, clinical symptoms of anhedonia, functional outcomes, and     behavioral indices of reward processing. This work will also identify brain targets by which     future novel anhedonia treatment may be evaluated.   "
31418|NCT02874521|"     The purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical     muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise     training.   "
31419|NCT02874508|"     To analyze whether non-cardiac surgery in high-risk cardio-vascular patients induces a     quantitative change in one or several leukocyte subpopulations and whether such changes are     associated with perioperative cardio-vascular events.   "
31420|NCT02874495|"     Crohn's disease goes along with an alteration of the quality of life, even in remission and     has a negative impact on stress management linked to the pain and the health. Conversely,     stress and psychological variables play a significant role in the pathogenesis of this     disease. These interrelations reflects the link between the brain and the digestive tract,     called brain-gut axis. The autonomic nervous system (ANS) is the neurological interface,     relaying in a bidirectional way, informations between the digestive tract and the central     nervous system (CNS).      Visceral information can thus modulate the functionnement of CNS's areas involved in pain     management but also in the management of emotional and cognitive behaviours. Yet, numerous     work demonstrate the existence of a dysfunction of the ANS during Crohn's disease, with a     dysautonomia of the sympatho-vagal balance.      Human brain respond by advance before and during the application of a painful stimulus that     enable the organism to regulate its nociceptive system in order to handle the aversive     stimulus incoming, via the activation of brin areas managing the pain, or the raise of pain     awareness.      The uncertain and not predictable nature of a painful crisis and/or an inflammatory relapse     in a chronic disease like Crohn's disease can be the origin of an anticipating apprehension     and anxiety, that could influence visceral perception (increasing it). Nevertheless, only few     studies exists about the differential role of certain or uncertain anticipation of the pain,     despite the fact that they are associated to different emotional, cognitive and behavioral     responses, and the effect of anticipation on painful visceral perception, have not yet been     studied for parents in remission of Crohn's disease.      The main goal is to search during certain and uncertain visceral anticipation, induced by     distension of an intra-rectal balloon for persons suffering from Crohn's disease in     remission, compared to control subjects, with an MRI functional study   "
31421|NCT02874482|"     Background:      Patients with schizophrenia are abnormally disturbed by information onsets, which may result     in a disadvantage in filtering relevant information. It seems that they accord the same     importance to all objects in a scene without taking into account the relevance of objects     (cognitive salience) or their emotional charge (salience emotional).      The paradigm of change blindness offers the interesting possibility of studying sensitivity     to the sudden irruption of visual information with ecological stimuli in schizophrenia. An     increased attentional capture by the irruption of visual information would suggest better     performance in patients than in healthy controls. Moreover, patients are disturbed to     processing of emotional information, in this way we would like to measure the impact of     emotional salience on the visual exploration.      Main aim:      The main objective is to evaluate, if patients with schizophrenia quickly detect changes     occurring on irrelevant objects in the understanding of the scene.      Secondary objectives:      To evaluate in patients with schizophrenia the impact of emotional salience using the same     paradigm.      To separate an explicit response (motors responses) with an implicit response (eye tracking     measures).      Methodology:      30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96     scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants'     speed and accuracy in explicitly reporting the changes via motor responses and their capacity     to implicitly detect changes via eye movements.   "
31444|NCT02874183|"     To assess the effectiveness of pharmacist's provided education in HF patients, in improving     patients' knowledge and self-efficacy, and to assess the impact of this intervention on the     rate of hospital readmission and emergency visits at 30-days, 60-days and 90-days after     discharge.   "
31492|NCT02873559|"     In this scientific clinical investigation we will test whether testosterone and progressive     resistance training can improve muscle strength and reduce the risk of falls in older men. In     addition, we will examine whether this treatment improves quality of life, functional     capacity, including sexual function and counteracts depression. Such a project have not been     performed earlier.   "
31422|NCT02874469|"     Sudden death is a public health problem with more than 300,000 cases per year in USA and     40,000 cases per year in France. Moreover, despite all recent therapeutic improvements     (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains     drastically poor and less than 50% of the patients admitted alive at hospital will survive to     the event at 1 year.      Outside all medications and technical care to improve patient prognosis, a psychological     evaluation looks also critical to detect the occurrence of a post traumatic stress     syndrome. In fact, along with the event severity, a variable period of amnesia related to     coma may favor the occurrence of such a syndrome and psychological issues, which at the end     may lead to impairment of patient quality of life.      Previous studies have evaluated the impact of an intensive care unit diary on psychological     distress in patients and relatives in the context of severe traumatisms. Such an evaluation     has however never been done in the specific setting of sudden death and the frequency of this     syndrome is unknown in this context.      Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on     the occurrence of a post traumatic stress syndrome after a sudden death.      Secondary objectives        -  To evaluate the frequency of the occurrence of a post traumatic stress syndrome and          other psycho traumatic symptoms after sudden death        -  To evaluate the impact of an intensive care unit diary on the severity of this syndrome,          psycho traumatic symptoms, and psychopathologic comorbidities        -  To evaluate the impact of the diary on psycho traumatic symptoms and their severity in          patient's relatives        -  To evaluate the satisfaction of the patients and their relatives regarding medical cares          in both groups (with and without diary)        -  Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated          personal with a specific formation in psychology        -  Qualitative evaluation of the diary        -  Evaluation of the paramedical feeling before and after the diary input in practice   "
31423|NCT02874456|"     The purpose of this study is to seek the presence of ZIKV in semen, to determine its     localization and to assess the efficiency of spermatozoa processing methods to obtain virus     free spermatozoa.   "
31424|NCT02874443|"     This project is a clustered randomized controlled trial of a knowledge translation     intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent     is to reduce the rate of cesarean section (CS) in first time mothers without increasing     maternal or neonatal morbidity. The guidelines were developed from data from the Consortium     for Safe Labor. The unit of randomization will be sites in Alberta that deliver   "
31425|NCT02874430|"     This phase II trial studies how well metformin hydrochloride works together with doxycycline     in treating patients with localized breast or uterine cancer. Metformin hydrochloride may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Doxycycline may stop the growth of bacteria by keeping them from making proteins and     minimized the toxic side effects of anti-cancer therapy. It is not yet known whether giving     metformin hydrochloride together with doxycycline may be a better way in treating patients     with localized breast or uterine cancer.   "
31426|NCT02874417|"     This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol     in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the     development and maintenance of various forms of psychopathology.   "
31427|NCT02874404|"     This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in     treating patients with diffuse large B-cell lymphoma that has returned after a period of     improvement or does not respond to treatment. TGR-1202 and ibrutinib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth.   "
31428|NCT02874391|"     Use of arteriovenous fistula for IV drug administration is controversial and often prohibited     by nephrologists. However, we have been using this method in our department for years now in     order to keep the patients 'veins for other fistulas in the future. The aim of this study is     to evaluate our practice and maybe provide a justification for a larger multi-center study     given the importance of this subject in patients with chronic renal failure.   "
31429|NCT02874378|"     Postoperative renal function recovery is very important to value the operation quality after     kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow     rate and perioperative renal function. Some animal experiments have revealed its beneficial     effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the     effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing     Cystatin C level and enhancing renal function after kidney transplantation.   "
31430|NCT02874365|"     A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and     ulcerative colitis), FAP patients and healthy controls. Investigate the morphological     characteristics of organoids, the expression of genes and proteins of the     Wnt/APC/beta-catenin pathway within both ISC.   "
31431|NCT02874352|"     This study will inform the feasibility of the High Resolution Impedance Manometry (HRIM)     system combined with Automated Impedance Manometry (AIM) analysis as a screening tool for     dysphagia and aspiration for the intensive care population with tracheostomy. This pilot     study aims to determine the incidence of dysphagia and aspiration risk in intensive care     patients with tracheostomy and the investigators hypothesise that the incidence of dysphagia     in intensive care patients with tracheostomy will be higher than in an age matched     population.   "
31432|NCT02874339|"     The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is     non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with     acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the     emergency department.   "
31433|NCT02874326|"     The purpose of this study is to determine whether long-acting octreotide is safe and     effective in the treatment of patients with Rendu-Osler-Weber (e.g. HHT).      The study hypothesis is that octreotide is safe and will reduce transfusion requirements and     endoscopy frequency in ROW patients with refractory anaemia due to bleeding gastrointestinal     telangiectasias.   "
31442|NCT02874209|"     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and     peripheral motor neurons, characterized by the rapidity of its evolution (median survival of     3 years). The pathophysiology of the disease is still poorly understood. Neuronal death     results from several cellular mechanisms entangled, including mitochondrial dysfunction. The     absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On     the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium     (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated     with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction     causing the accumulation in the sodium and calcium cell causing neuronal death. These studies     were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease, stroke and     brain tumors. They demonstrated that sodium MRI could be an effective and sensitive biomarker     for detecting and quantifying neuronal degeneration. The goal of this study is to assess     neuronal damage noninvasively by MRI sodium in amyotrophic lateral sclerosis.   "
31521|NCT02873182|"     A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to     assess autonomic neural function during spinal and/or pelvic surgery in women and men.   "
31434|NCT02874313|"     Objectives: Main objective: To compare the percentage of patients with new microaneurysm or     hard exudates after 12 months between the CPAP group and the control group. Secondary     objectives: To compare the central macula volume, ganglion cell layer thickness and central     fovea thickness at baseline and 12, 24 and 52 weeks after randomization between the two study     groups; to compare the percentage of patients who have an improvement loss of visual acuity     (more than or equal to 15 letters in patients with macular edema and more than or equal to     five letters in patients without macular edema) among the baseline visit and the weeks 12, 24     and 52 between the two study groups; to compare the percentage of patients who reach a higher     level of diabetic retinopathy at 54 weeks between the two study groups; to compare the     resolution time of central macula thickness from the randomization between the two study     groups; to compare the glycated hemoglobin at baseline and 12, 24 and 52 weeks after     randomization between the two study groups; and to compare the serum levels of inflammatory     cytokines, oxidative stress biomarkers, sympathetic tone, and intake regulator hormones at     baseline and 12 and 52 weeks after randomization between the two study groups.      Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional     treatment-controlled trial of 12 months of duration.      Subjects will randomize to conventional dietary and pharmacological treatment or conventional     dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study     subjects: Subjects 35 to 75 years with type 2 diabetes and a clinical diagnosis of mild     diabetic retinopathy (with or without macular edema), better visual acuity from 20/40 to     20/320 letters and refraction with a spherical equivalent less than ± 5 diopter.      Efficacy variables: Thickness of the central sub-field, central subfield volume, ganglion     cell layer thickness, and presence of clinical or subclinical macular edema, serous retinal     or retinal pigment epithelium detachment, intraretinal cysts or haemorrhages assessed by     optical coherence tomography; presence of cotton exudates, microhemorrhages, microaneurysms,     , microvascular retinal abnormalities, or a vein/artery ratio > 2/1 in examination of ocular     fundus/retinography; better corrected visual acuity; glycosylated hemoglobin (HbA1c); fasting     glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; lipid profile,     troponin I, proBNP, homocysteine and C-reactive protein; systemic biomarkers of inflammation,     oxidative stress, endothelial damage, sympathetic activity and appetite-regulating hormones     and clinical questionnaires: short form (SF)-12, visual function questionnaire (VFQ25) and     iPAQ.   "
31435|NCT02874300|"     People with memory problems can struggle with everyday activities and may stop doing things     they want to do. They are more prone to accidents and have a higher risk of falling.     Occupational therapists can advise how to do daily activities more easily and safely.     Physiotherapists can teach exercises which increase activity and improve balance, and may     help maintain memory.      There is little research on how to make these interventions work for people with memory     problems. The investigators have developed two activity and exercise programmes suitable for     people with memory problems. The investigators will study them in a feasibility trial. One     programme involves high-intensity supervision (50 visits over one year), the other     moderate-intensity supervision (11 visits over three months). The investigators will compare     these with standard falls prevention assessment and advice (1-3 therapist visits). The     investigators will encourage participants to exercise by themselves or with family members     over the year, and once the programme ends.      People with early dementia or memory problems will be eligible for this study. If possible,     the investigators will also recruit a family member. Participants will be recruited from     memory clinics or the 'Join Dementia Research' register. The intervention will be delivered     over a maximum of 1 year in their own homes. Researchers will visit to collect information at     baseline and at 12 months. The investigators will measure ability in activities of daily     living, activity, quality of life, memory and health service use. Participants will complete     weekly falls diaries. Intervention persistence will be measured for 24 months.      The investigators will conduct interviews and discussion groups to help develop the     programmes, and understand how they work in practice ('process evaluation'). The     investigators will also do initial work on health economic modelling, dissemination and     implementation.      Study findings will be used to refine the intervention, and inform a planned definitive     randomised controlled trial.   "
31436|NCT02874287|"     The purpose of this study is to evaluate whether treated with hydroxychloroquine could     improve therapeutic effect for patients with high-risk coronary artery disease.   "
31501|NCT02873442|"     To evaluate the safety and effectiveness of cell therapy using precision cells Combined With     TACE in Advanced Liver Cancer.      Eligibility:      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of     age who have been diagnosed with Advanced Liver Cancer.   "
31513|NCT02873286|"     A total of 400 subjects will be recruited into five treatment subject groups à 80     subjects.Subject will receive two administrations 4 weeks apart which will consist of     MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS).   "
31437|NCT02874274|"     This is a study to see whether participation in the Edmond J. Safra Interdisciplinary Home     Visit Program for Advanced Parkinson's (HVP) increases the rate of age-appropriate     vaccinations in people with advanced Parkinson's Disease (PD) and related disorders. This     study will evaluate the impact of the HVP on the rate of common illnesses such as flu and     pneumonia in patients with advanced PD and related disorders over the course of one year.      As there is currently no data available on the baseline rate of vaccinations in either     homebound or less disabled PD populations, investigators will seek to establish the baseline     rate of vaccinations, barriers to getting vaccinated, and baseline healthcare utilization in     these populations by piloting (Phase 1) and then implementing (Phase 2) a survey via     telephone interviews. Investigators will then test feasibility of offering influenza and     pneumococcal vaccinations, as appropriate, to the homebound individuals in our HVP cohort     (Phase 3), and will compare their pre- and post-intervention rates of both outpatient and     acute healthcare utilization and self-reported illness.   "
31438|NCT02874261|"     Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a     diverse and growing list of disorders including cardiovascular disease. During WBPA, patients     lie in the supine position on a bed that is capable of translating back and forth parallel to     the ground, along the head-to-foot axis of the patient. Thus, this treatment is best     described as a form of passive exercise. The frequency of the translation (up to 180     cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by     the patient or health care professional.      The science behind the therapeutic effects of WBPA still remains largely unknown.      We are observing how WBPA may impact on sleep and activity in individuals with PD   "
31439|NCT02874248|"     This study is conducted to evaluate the effect of single and multiple therapeutic and     supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability     and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula     (QTcF).   "
31440|NCT02874235|"     This study compares music therapy with verbal psychotherapy (treatment as usual) in an     outpatient psychiatric clinic for traumatized refugees. Based on positive results from a     pilot study, the randomized clinical trial are a non-inferiority design to detect whether     music therapy is not less effective than verbal therapy carried out by psychologists, and can     serve as a complementary treatment modality (n=70).      The participants are adult Arabic or Danish speaking refugees suffering from posttraumatic     stress disorder (PTSD). The patients are referred to outpatient treatment by their medical     doctor. Data collection takes place in three clinics in Region Zealand, Denmark. The music     therapy method used are Guided Imagery and Music (GIM).      Primary outcome is pre and post measures of HTQ (Harvard Trauma Questionaire) and secondary     outcomes are pre and post measures of Quality of Life Questionnaire (WHO-5), Tension     Dissociation Scale (DSS), Somatoform Dissociation Questionaire (SDQ) , Revised Adult     Attachment Scale (RAAS) and physiological measures (salivary oxytocin, betaendorphin and     Substance P).   "
31441|NCT02874222|"     Breast cancer is one of the most prevalent cancers with 207,090 new cases of breast cancer     and 39,840 deaths in women predicted for 2010 in the United States. Aromatase inhibitors     (AIs) are used as first-line adjuvant therapy for postmenopausal women with early stage     breast cancer. The effectiveness of current therapy is widely recognized to be compromised by     poor compliance because of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), a     syndrome that affects up to 40-50% of women who take these medications. The syndrome that was     not recognized during the registration trials for this class of drugs, it can lead to     discontinuation in up to 24% of women over 2 years. Knowledge that can be used to prevent     discontinuation of these important agents because of severe AIMSS is urgently needed.   "
31445|NCT02874170|"     Drepanocytose disease is the first genetic disease in the world. It results in the synthesis     of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to     structural changes of red blood cells (RBC) which then take the shape of a sickle, become     more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass     destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with     low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the     microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the     failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to     life-threatening patients. Preliminary studies conducted on patients with drepanocytose     disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in     the supply and use of oxygen. To date, the translation of this metabolic remodeling in the     muscle work is not known.      This project's main objective is to evaluate muscle function in drepanocytose attempted     patients. We hypothesized that muscle remodeling associated with sickle cell disease have a     functional impact on strength and muscle metabolism. The main objective is to characterize     the maximal voluntary plantar flexor muscles. The criteria for these targets will be based on     the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and sickle     cell patients (HbSS) oxygen saturation.      The strictly non-invasive approach proposed in this project will study the functional     parameters of the muscle of sickle cell disease and the possible link with the clinical     manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation     and pH plays a major role.   "
31452|NCT02874079|"     Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis,     linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200     pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous     dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in     Europe. The incidence of the individual entities is slight significantly different within     Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA and     South America. The most common of these disorders is the bullous pemphigoid.      A considerable progress has been made in the last years to elucidate the pathogenic role of     autoantibodies in these diseases. To this end, various in vitro and animal experiments have     been used to understand some basic pathophysiological mechanisms in these diseases. Further     studies are currently being carried out to explain a precise elucidation of the disease     process and to be able to treat the patients targeted later.      At present, however, no data are available to explain why certain individuals develop the     autoimmune disease and others do not. Epidemiological studies showed some triggers to the     development of autoimmune dysregulation, e.g. drugs.      Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the     disease. A clear association with certain HLA regions have been shown in patients with     pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the     HLA-DRB1*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was     described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear     IgA dermatosis the association with HLA antigens is less pronounced. Another indication of     the importance of the genetic background in these diseases can be elucidated from the     observation of autoantibodies at a low concentration in healthy relatives of pemphigus     patients.   "
31446|NCT02874157|"     Viral infections are only recently been investigated in patients on mechanical ventilation     (MV) in ICU. It is especially the progress in the direct detection of these pathogens that     allowed intensivists to try to assess objectively the impact of viruses in their patients.     This is of course of viral infections Community (influenza virus, rhinovirus ...), but some     viruses also occur under mechanical ventilation in immunocompetent adults. This is called     viral infection nosocomial whose Herpesviridae are the most frequent and best studied. This     replication Herpesviridae in ICU patients is usually a reactivation as primary infection.     This reactivation is explained by the fact that after a few days of mechanical ventilation     appears immunoparalysis, which can make the bed of bacterial or viral infection.Several     studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients.     For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%,     Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work,     however, has to date compared these techniques in the intensive care patient. In a subject     shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA     is 80%, when compared to antigenemia. Moreover this same study shows that half of the     positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR     may be more sensitive than antigenemia. This exam has never been validated to date in     intensive care. Finally, no work has so far evaluated the diagnostic performance of     quantitative PCR performed on BAL   "
31447|NCT02874144|"     To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving     signs and symptoms of disease in patients with sinusitis.   "
31448|NCT02874131|"     This study is a randomized controlled trial comparing an integrated treatment, Behavioral     Activation + Cognitive Processing Therapy (BA + CPT), to CPT alone among active-duty service     members with posttraumatic stress disorder (PTSD) and comorbid major depressive disorder     (MDD). Participants will complete assessor-administered and self-report measures at pre- and     post-treatment assessments, as well as a 3-month follow-up. Additionally, participants will     complete self-report measures of PTSD and MDD symptoms at each therapy session.   "
31449|NCT02874118|"     The frailty and frail elderly was defined in 2001 by Fried as a physiological state of     heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3     categories: frail, pre-frail and not frail. The prevalence of frailty in the general     population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years.     This concept is explored in some chronic diseases, in order to prevent the loss of autonomy     and tailor the treatment. In the carrier population of HIV, a North American retrospective     study showed the frailty syndrome manifested as early as 10 years before, than in the general     population. Furthermore various studies show in this specific population, increased incidence     of diseases linked to age, suggesting an accelerated and premature aging.      objectives: The objective of this study is to determine the prevalence of frailty defined     Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.   "
31450|NCT02874105|"     The rotator cuff tendinopathy is very common and associated with degenerative or traumatic     changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps.     Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff     which means a loss of mobility or strength. The origin of this pathology remains     controversial and many causes have been evoked (subacromial mechanical impingement,     degenerative changes, muscle imbalance…). The clinical impairment is not always the same and     varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder.     The first treatment of the rotator cuff pathology is always non surgical and consists in     relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and     physiotherapy. The aim of this management is to relieve pain and to restore the mobility and     a good function of the shoulder.      There is no consensus about the physiotherapy protocol for the treatment of the rotator cuff     tendinopathy. In France, the most used physiotherapy protocol uses the strengthening of the     muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and     which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this     approach is to augment the subacromial space in order to decrease the inflammation of the     rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC)     uses a new method of glenohumeral centering in closed kinetic chain has been described (3C     Concept for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of     physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order     to simplify and to improve its reliability, a special device called Scapuleo® has been     developed. The aim of this device is to help the physiotherapist to realize simultaneously a     subacromial decompression, a specific strengthening of the rotator cuff muscles and an     optimal activation of the lower trapezius and the anterior serratus.      Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol     for the medical treatment of the rotator cuff tendinopathy without full-thickness tear.      We proposed a prospective and randomized study. All the patients treated in our department     for simple tendinopathy of the rotator cuff or partial thickness tear were included in this     study after signed consent. The physiotherapy protocol consists in 20 sessions of either     Conventional program (Control group) or Dynamic Humeral Centering (Study group). The     clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and     Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study     hypothesis. The assessor of all outcomes was blinded to the interventions.   "
31483|NCT02873676|"     The purposes of this study were to investigate the prevalence and risk factors for sarcopenia     in Chinese adults and elderly, and evaluate the effect of Lifestyle Modification Project     (LMP) on Clinical Outcomes, Quality of Life and Cost-effectiveness Ratio.   "
31451|NCT02874092|"     This is an open label study to assess the improvement in the Disease Activity Score for     28-joint counts (DAS28) with ticagrelor given at 90 mg twice daily in patients with RA who     have active disease despite MTX therapy (as defined by the inclusion/exclusion criteria).     There will also be a cross sectional analysis of baseline platelet activity in subjects with     rheumatoid arthritis and osteoarthritis. Subjects in the OA cohort will not receive any study     medication, and will only have one study visit.      Patients will receive 90 mg ticagrelor orally bid. The patients will receive drug for     30-days. Methotrexate dose will remain stable throughout the study duration.   "
31453|NCT02874066|"     Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of     antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin     (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of     treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting     antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent     safety profiles to treat patients with severe renal impairment. With regard to     ombitasvir/paritaprevir/ritonavir plus dasabuvir (PrOD) treatment, a phase 2 study (RUBY-1)     study has shown 90% of SVR in treatment-naive HCV-1 patients with chronic kidney disease     (CKD) stage 4 or 5. Among the HCV-1b patients, who received PrOD for 12 weeks, all 7 patients     achieved SVR. Although the data confirmed the excellent safety and efficacy in HCV-1b     patients with severe renal impairment, the patient number was small and the data with regard     to treatment-experienced patients was lacking. Therefore, we aimed to evaluated the safety     and efficacy of ProD for 12 weeks in treatment-naive and treatment-experienced HCV-1b     patients receiving hemodialysis.   "
31454|NCT02874053|"     Background:      People with cancer often have to make complex decisions about their treatment. For some of     these decisions, they have to weigh the benefits of a treatment against its side effects.     They may have to think about its potential to increase the risk of another disease. One     example is hormone replacement therapy. That reduces a woman s risk of getting colorectal     cancer, but it raises her risk of getting breast cancer. Researchers want to learn more about     how people make tradeoff decisions like these.      Objective:      To learn about how people respond to information about hypothetical health and medical     treatment options.      Eligibility:      Adults ages 18 70.      Design:      Participants will have one 30-minute visit.      Participants will complete a series of short questionnaires. These will be about their     beliefs and values. Some may be about cancer and heart disease risk. Participants ages 18 to     29 will answer questions about sexual health.      Participants will write a paragraph or two about a room in their house or about a life event.      Participants will read a series of stories. These will describe different hypothetical health     treatments.      The stories describe a pill that lowers the risk of one health condition, but raises the risk     for another. After each story, participants will note how willing they are to take the pill.      Participants will answer questions about the information that they got. They will also answer     questions about their health, beliefs, and opinions.      Participants will do 2 attention tasks computer.   "
31455|NCT02874040|"     Study the efficacy of endoresection of the tumor scar or, when surgery is not possible,     transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary     enucleation   "
31456|NCT02874027|"     Microbiome studies may be highlighted as crucial in the development of depression for TBI     patients. The microbiota-gut-brain connection may further provide an opportunity for     microbiota manipulation to treat the TBI patients with depression.This study is to     investigate whether exist the relationship between depression and circadian rhythm of     patients with TBI or not and focus the study on the potential of the host-microbiota     interaction in regulating depression.   "
31457|NCT02874014|"     The study is to examine a moderate hypofractionation regimen of proton beam therapy for high     risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are     treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the     regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180     centigray/fraction) simultaneously. The overall treatment time is 5 weeks.   "
31458|NCT02874001|"     Validation of the PO-BADO in its short and long versions that need a standardized validation     process with the inclusion of 450 Patients   "
31459|NCT02873988|"     Airway epithelium integrity is essential to maintain its role of mechanical and functional     barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its     integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial     repair may participate in airway remodelling. The objective was to determine if airway     epithelial wound repair of airway epithelium is abnormal in COPD.   "
31460|NCT02873975|"     This research study is studying a checkpoint kinase 1 (CHK1) inhibitor as a possible     treatment for advanced solid tumors that harbor genetic alterations in the homologous repair     (HR) pathway or with genetic alterations that indicate replication stress.   "
31461|NCT02873962|"     This research study is evaluating two drugs called Nivolumab and Bevacizumab as a possible     treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.   "
31484|NCT02873663|"     The investigators will test the validity of biomarkers for the detection of heavy alcohol use     in patients with and without liver disease.   "
31462|NCT02873949|"     Etiopathology of periodontitis is complex and various risk factors are known :        -  Bacterial factors: major risk factor. Although the presence of periodontopathogen          bacteria is necessary for the onset of periodontitis, these microorganisms are not          sufficient for progression of all periodontal disease.        -  Immune factor: host immune response modulates the disease evolution to destruction or          recovery. The most studied cytokine in periodontology is IL-1 that induces various          immune reactions and bone resorption directly or indirectly through the stimulation of          prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are          responsible of the degradation of bone extracellular matrix.      Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is modulated     by new identified molecules such as Triggering Receptor Expressed on Myeloid cells (TREM)     whose role in periodontitis is unknown.      The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers     in infected sites and in healthy sites in patients affected by periodontitis.      Other purposes are        1. Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients          affected by periodontitis and in healthy patients        2. Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic          periodontitis treatment        3. Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and          clinical signs of periodontitis        4. Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment        5. Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2        6. Search for the most observed bacteria in presence of high concentrations of soluble          TREM-1 and TREM-2 before and after etiologic treatment        7. Evaluation of the impact of psychological stress measured through salivary cortisol          level in saliva on TREM-1 and -2 expression        8. Evaluation of the impact of psychological stress through stress and anxiety          auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations          in crevicular fluid of healthy and pathologic teeth.   "
31463|NCT02873936|"     The primary objective of this study is to evaluate the effects of filgotinib versus placebo     in adults with active rheumatoid arthritis (RA) who have an inadequate response to biologic     disease-modifying anti-rheumatic drug(s) (DMARDs) treatment.   "
31464|NCT02873923|"     The DATECAN-2 project aims at assessing the surrogate properties for OS of several     time-to-event endpoints through meta-analyses of completed and published randomized     controlled trials. Two main cancer localization are concerned: breast cancer and soft-tissue     sarcomas. The impact of survival endpoints' definitions on the trials' results and     conclusions will also be evaluated.   "
31465|NCT02873910|"     The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-119 for     reduction of susceptibility to infections and other complaints after extreme physical stress     (participation in a marathon).   "
31498|NCT02873481|"     This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in     CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond     Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will     provide the necessary preliminary data to fuel an appropriately powered randomized controlled     trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing stress     resilience, and improving maternal-child outcomes among overweight/obese diverse women.     Because increasing physical activity has been found to have important mental health effects     and maternal-child outcomes, it stands to reason that this innovative intervention has the     potential to impact the way prenatal care is delivered in high risk populations.   "
31512|NCT02873299|"     The purpose of this study is to compare two slightly different methods of transcranial     magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)   "
31466|NCT02873897|"     In independent elderly people, the aim is to test recipes for different types of food from     different countries (starter, main course with culinary aids, carrot purees, desserts and     smoothies) likely to improve sensory acceptability of foods for elderly people who are     dependent for their meals (persons for whom at least one meal per day is provided by a     catering service - meals at home, old people's home). All of the recipes were developed     thanks to the first two parts of the OPTIFEL project so as to take into account the needs of     elderly people and recommendations in each country. The interest is to increase the sapidity/     attractiveness of meals by optimizing sensory properties and the nutritional content of the     foods, to meet the nutritional needs of this specific population with enriched recipes (with     leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different     cultures. This ongoing research is being conducted on 2-4 different variants of each type of     product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids)     and garnished (carrot puree), an apple-based dessert and fruit smoothies.      For each product family, two products will be selected for each country: the preferred     product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins     and minerals) and the standard product without enrichment.      Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary     aids, 2 carrot purees, 2 desserts and 1 smoothie   "
31467|NCT02873884|"     The first aim of this study is to test the effect of the case management on the evolution of     therapeutic alliance in patients with first episode psychosis in comparison with traditional     nursing. The second aim is to test the effect of case management on nurses' well-being in     comparison with traditional nursing. The third objective aims to show if therapeutic alliance     is associated with insight in patients and with clinical and demographic data.   "
31468|NCT02873871|"     Randomized clinical trial to compare radial artery patency after transradial coronary     catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or     therapeutic coronary catheterization will be prospectively enrolled in this single-center     trial and will be randomized to radial hemostasis with TerumoBand® or a standardized     compressive dressing with gauze and elastic bandage.   "
31469|NCT02873858|"     Malnutrition is a frequent problem in persons older than 65 years: the prevalence of     malnutrition can reach 25 to 29% in persons living at home who require help, figures vary     between 19 and 38% for those living in institutions, and finally, the prevalence of     malnutrition in hospitalized elderly patients can reach 30 to 90%. A few studies have     attempted to explain modifications in attitudes, behaviour, the frequency of meals or     nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this     project is to test the hypothesis that perhaps it is not as much the capacity to perceive a     smell or a taste that affects eating behaviour in the elderly as their ability to distinguish     between smells or tastes on the one hand (perceptual processing), and their ability to     correctly interpret a chemosensory signal on the other (cognitive processing).   "
31470|NCT02873845|"     Altered quality of life in patients with stage III or IV colon cancer is well known. At their     sides, their spouse/partner must also cope with the suffering caused by the disease and the     upheavals that it engenders, with the treatments, in the organization of their everyday life.     The physical, emotional, social and financial impact of cancer in general and its treatment     on care-givers has already been studied. However, there are no data concerning the objective     burden, that is to say the nature and the magnitude of the care weighing on the spouse of     persons with colon cancer. Objective is to develop and validate a questionnaire that can be     completed by the spouse/partner of patients with stage III or IV colon cancer so as to     evaluate the burden of the disease in everyday life. It will allow medico‐social     professionals to identify spouses/partners in difficulty and the needs of patients so as to     offer the best support.   "
31485|NCT02873650|"     To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral     dose in subjects with moderate and severe hepatic impairment.   "
31486|NCT02873637|"     The main objective of this study is to show that postoperative Total Knee Replacement (TKR),     an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor     quadriceps femoral perineural catheter that (KTF) infused with even low doses of local     anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking     of the knee feasible at the bedside.      Patients will be randomized in two arms:        -  catheter in position under sartorial (experimental group)        -  femoral catheter (control group)   "
31471|NCT02873832|"     Heat-shock proteins (HSP) have been very highly conserved throughout the evolution of species     and are characterized by their chaperone function, thanks to their ability to prevent     aggregation and to promote the renaturation/break down of damaged proteins. Among other     targets, they also chaperone JAK2, a key step that is deregulated in signalling in     myeloproliferative syndromes (MPS) because of the JAK2V617F mutation. These HSP also have a     potent cytoprotective action through their multiples inhibiting effects on apoptotic     processes.      Little is known about levels of HSP expression, in particular for HSP70 and HSP27, in MPS     cells.      However, in vitro studies of different cell models have shown the interest of HSP90     inhibitors in slowing cell proliferation in MPS. These results have been confirmed in animal     models with results in terms of blood counts and overall survival. In addition, it seems that     the V617F mutated form of JAK2 is more sensitive than the wild-type to HSP90 inhibitors.     Finally, inhibitors of HSP90 remain efficacious with regard to the inhibition of cell growth,     even in cases of resistance to JAK2 inhibitors. Nonetheless, HSP90 inhibitors are known to     stimulate the expression of other HSP, notably HSP27 and HSP70, which are, through their     properties, tumorigenic and could lead to an escape phenomenon. Thus the combined use of     several HSP inhibitors could be beneficial, and eventually present synergistic effects on the     inhibition of tumour processes.   "
31472|NCT02873819|"     This is a multi-center, randomized, double-blind clinical trial to assess the safety and     efficacy of GL-0817 as a means to prevent disease recurrence in patients considered at     high-risk following surgery and adjuvant chemoradiotherapy.   "
31473|NCT02873806|"     The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two     iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two     anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.   "
31474|NCT02873793|"     By analogy with the mouse, the activity of control pathways for transposable elements (TE) in     foetal primordial germinal cells could prove to be a determinant for fertility in adulthood     in humans. Moreover, defects in the control of transposable elements (TE) could also     contribute to the aetiology of germinal testicular cancer, by inducing chromosomal     instability and tumorigenesis. In this context, the aim is to analyse a specific type of     adult germinal testicular cancers, seminomas. Directly related to our research interest, the     histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent     of germinal cells normally present in foetuses. The investigator postulates that these     similarities could also extend to the biology of transposable elements (TE), and in     particular to the initiation of the control of these elements. The management of seminomas     requires surgery, orchiectomy, which consists of the total excision of the affected     testicles. Using high-resolution high-throughput sequencing techniques, we propose to analyse     the control pathways of transposable elements (TE) in tumour samples harvested from surgical     pieces in comparison with adjacent healthy tissue. The results obtained in these tumour     samples will be compared with those in normal foetal gonad samples.   "
31475|NCT02873780|"     The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk     test and the 3 minute step test, for COPD patients.   "
31476|NCT02873767|"     This study is designed to evaluate the safety and tolerability of single ascending doses of     UCB4019 administered by subcutaneous injection in healthy subjects.   "
31477|NCT02873754|"     This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile     intervention to target smoking-cessation and increase physical activity among low-income     persons. The intervention is called Smoking Treatment and Exercise Program for Underserved     Populations (STEP UP).   "
31478|NCT02873741|"     The purpose of this research is to study different strategies to identify women at highest     risk for anal cancer. Primarily, investigators want to study a risk assessment called the     Anal Cancer Risk Index; it gives women an overall number score based on risk factors that     they may have for anal cancer, such as age, number of sexual partners, or smoking.     Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are     more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The     study team will collect swabs of the cervix and the anus to study different laboratory tests     that could identify women at highest risk of cervical and anal cancer. These laboratory tests     include an anal pap smear, tests for markers of disease and tests that detect the HPV types     most likely to cause cancer. The study team would like to see which of these laboratory tests     do the best job at predicting precancerous lesions in the anus and are better indicators of     risk for cancer. After collecting these swabs, women will have a procedure called high     resolution anoscopy where investigators look closely at the anus and biopsy any suspicious     areas. Finally, the study team will look for HPV proteins and changes that HPV can make in     cells to see if these tests predict anal lesions.   "
31479|NCT02873728|"     The goals of this series of studies is to test the effect of RIC on chronic leg ulcers     (Diabetic ulcers and venous ulcers) - and to improve the understanding of its biological     mechanism. This is a prospective, double-blind, randomized, shame procedure-controlled study.   "
31480|NCT02873715|"     This study is designed to translate an evidence-based family-based weight loss treatment for     childhood obesity (FBT) into primary care settings using co-located interventionists to serve     as a model for care delivered within a patient-centered medical home. FBT plus enhanced usual     care (FBT+EUC) will be compared to enhanced usual care (EUC) alone, and the families will be     followed for a 2 year period to assess between group differences in the targeted child and     parent outcomes, weight changes in non-targeted siblings who are overweight/obese, parent and     child changes in delay of gratification, and how these changes relate to weight loss, and the     assessment of how provider attitudes predict their intention to use FBT in the future. The     results of this study will inform future dissemination and implementation of FBT into primary     care settings.   "
31481|NCT02873702|"     The purpose of this study is to determine the efficacy of dexlansoprazole compared to     lansoprazole in healing erosive esophagitis (EE) in Chinese participants.   "
31482|NCT02873689|"     The purpose of this study is to determine the efficacy of dexlansoprazole compared to placebo     in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with     symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).   "
31493|NCT02873546|"     The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial     Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal     (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the     application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at     short term (1 week post-treatment) and mild term (3 weeks post-treatment).      After unblinding, patients who received placebo treatment could be received active tDCS.   "
31494|NCT02873533|"     The analysis of this study will achieve an improvement in the management of patients over 70     years with adaptation of chemotherapy regimens after analysis of the subject and its     psychosocial environment.      The analysis of socio-economic impacts will implement actions to optimize the care of the     elderly while emphasizing the value of management / cost of care.   "
31495|NCT02873520|"     To evaluate the safety and effectiveness of cell therapy using Precision Cells to treat     Advanced Gastric Cancer.      Eligibility:      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of     age who have been diagnosed with Advanced Gastric Cancer.   "
31496|NCT02873507|"     A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft     steatosis prior to transplantation will be conducted. An MRI of the donor liver within the     transport cooler will be obtained on its way to the operating room.   "
31497|NCT02873494|"     PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography     (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to     compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler     echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.   "
31499|NCT02873468|"     The purpose of this study is to evaluate the efficacy of three doses of fluticasone     propionate oral (viscous suspension) on changes of eosinophilic infiltration in esophageal     biopsies.   "
31502|NCT02873429|"     This project focuses on whether nonspecific factors as well as patient characteristics     contribute to treatment outcome differences. The project uses assessment instruments,     computerized adaptive tests (CATs), from the Patient-Reported Outcomes Measurement     Information System (PROMIS®). The research team has recently developed and tested (using     PROMIS methods) a set of instruments to assess non-specific factors in healing from the     patient's perspective. These instruments, the Healing Encounters and Attitudes Lists (HEAL)     assess the Patient-Provider Connection, Treatment Expectancy, views of the Healthcare     Environment, Positive and Negative Attitudes, Spirituality, and Attitude toward Complementary     and Alternative Medicine (CAM). HEAL CAT's, like other PROMIS CATs, are brief, easy to use     and understand, and are designed to apply to a broad spectrum of treatments and health     conditions. In this project, the investigators aim to 1) evaluate whether HEAL predicts     chronic pain treatment outcomes, 2) examine heterogeneity of treatment effects based upon     HEAL and PROMIS scores in integrative and conventional medicine settings, and 3) interview     patients and their clinicians regarding the utility of HEAL, PROMIS and a Pain Log for     enhancing communication. The investigators will administer HEAL CATs and other PROMIS CATs     (depression, anxiety, sleep disturbance, fatigue and physical function) to 200 patients who     are starting treatment for chronic pain in integrative medicine and conventional medicine     settings. Follow-up assessments will be completed 2 and 4 months after baseline testing. The     investigators will evaluate factors that may predict which patients judge themselves to be     improved, the same, or worsened. Some of the possible factors that may contribute to     improvement include HEAL scores, emotional distress, or the preference for CAM or     conventional treatment. The investigators are also interested in learning whether patients     find the assessments to be clear and useful. A subset of 50 patients and approximately 10     clinicians will complete interviews about the HEAL and PROMIS questions, and about the Pain     Log developed by a patient advocacy group partner, the American Chronic Pain Association. By     interviewing patients and their healthcare providers, the investigators hope to determine the     clarity and acceptability of the HEAL and other assessments, and to learn whether HEAL and     PROMIS summaries enhance patient-provider communication in the clinical partnership.   "
31503|NCT02873416|"     To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy     to treat Advanced Lung Cancer.      Eligibility:      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of     age who have been diagnosed with Advanced Lung Cancer.   "
31504|NCT02873403|"     Around 250 millions of people in the world (3.8%) have knee osteoarthritis (KOA). Due to     aging and increasing obesity, the prevalence of KOA is expected to increase in the developed     country in the next 20 years. KOA decreases quality of life of patients through chronic pain,     joint stiffness, and reduced social activity, which influence emotional wellness as well. KOA     has also impact on the biomechanics of the lower limbs, leading or amplifying the     tibiofemoral misalignment and an increase of the medial knee joint loading. Increase of the     medial knee joint loading may lead patients into a vicious circle by increasing knee pain,     decreasing activities, increasing weight and disease progression. Knee brace is a     non-pharmacological treatment recommended for KOA. It aims to reduce misalignment of the     limb. However, the main issue is the poor compliance because of lack of effectiveness, more     drawbacks than benefits, discomfort, bad fitting, migration of the brace, bulkiness,     aesthetic, skin irritation, blisters and too much pressure on the knee. By its freedom in     design, 3D printing may resolve most of these complaints.      This study aims to compare clinical and biomechanical effectiveness, comfort and patients     complaints of a knee brace made by 3D printing to a conventional knee brace.      The institute for Applied Health Research of Glasgow Caledonian University (GCU) will lead     the experimental trial. They will recruit men or women (40 to 70 years old) suffering from     medial KOA in Glasgow area. Participants will be in study for 10 weeks. During this period,     they will wear 2 different knee braces for two weeks each with a 1-week period without knee     brace between. Participants will have five visits to GCU: once for leg measurement to make     knee braces and four times to fill questionnaires and perform gait analysis. Besides, they     will wear activity monitor for 3 non-consecutive weeks.   "
31505|NCT02873390|"     To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat     advanced cancer.      Individuals greater than or equal to 18 years of age and less than or equal to 70 years of     age who have been diagnosed with relapsed or refractory cancer that has not responded to or     has relapsed after standard treatment.   "
31506|NCT02873377|"     Construction workers have the highest rate of smoking among all occupations, and are     frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with     smoking to increase their health risks. Minority construction workers, in particular, have     higher smoking and lower cessation rates compared to other groups, and they generally show     lower access and participation in cessation and health promotion services. The number of     Hispanic workers employed in the construction industry in the US has tripled in the past     decade to 2.6 million (23% of all construction workers). This study will develop, administer,     and evaluate a novel smoking cessation program in a hard-to-reach and underserved population     of Hispanic male construction workers using using pilot cluster randomized clinical trial     (RCT) to test the developed intervention for feasibility and potential efficacy.   "
31507|NCT02873364|"     Chronic spontaneous urticaria is an inflammatory disease which is characterized with     intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent     studies have suggested a role for vitamin D in modulation of immune system and pathogenesis     of chronic urticaria.   "
31508|NCT02873351|"     From 3 large patient databases, patients diagnosed with AMD who have never taken     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD     at 79 years.      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects     the retina and downregulates VEGF, which is the cause of neovascularization.      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients     with AMD, and measure the effects on surrogate functional biomarkers of AMD.   "
31509|NCT02873338|"     The purpose of this study is to determine whether CX-01 when given together with standard     induction and consolidation therapy for acute myeloid leukemia (AML) will increase the     effectiveness of the induction/consolidation therapy. Three different doses of CX-01 will be     studied and safety and tolerability will be assessed.   "
31510|NCT02873325|"     DESIGN:      Disease registry - non-interventional.      INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or     cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.   "
31511|NCT02873312|"     Approximately 10 US Study Sites will participate over total 18 months Study population will     consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3     months.      Primary Study Objective        1. To assess efficacy of the StimRouter stimulation therapy in improving OAB symptoms of          urgency and frequency as measured by Patient Voiding Diary when targeting the posterior          tibial nerve        2. To assess safety of the StimRouter therapy      Secondary Study Objective      To evaluate:      Efficacy of the StimRouter stimulation therapy in decreasing specific OAB symptoms of     urgency, frequency, and urinary urge incontinence as measured by the Global Response     Assessment (GRA) and 7-day Patient Voiding Diary      Study Design is prospective, multi-center, randomized, double-blinded      Primary Endpoint The primary efficacy endpoint will be the difference between the     investigational and control groups in proportion of responders, defined as a return to normal     voiding (7-day average in voids/leak episodes < 8) OR > 50% improvement in average voiding     frequency above 8 that patient had at baseline OR > 50% improvement in average number of     moderate to severe urgency episodes at approximately three months after programming as     measured by 7-day Patient Voiding Diary.      Primary Outcomes:        1. Proportion of responders based on Patient Voiding Diary        2. Adverse Event Reports      Secondary Endpoints:      The secondary efficacy endpoint will be the difference in specific OAB symptoms of urgency,     frequency, and urinary urge incontinence as measured based on (1) the difference in     proportion of subjects in the investigational and control groups who have moderately or     markedly improved overall response on a 7 level Global Response Assessment (GRA) at     approximately three months after programming; and (2) the difference in responses on the     7-day Patient Voiding Diary between the baseline visit and approximately three months after     programming.      Secondary Outcomes:        1. Global Response Assessment (GRA)        2. Urgency, frequency, and urinary urge incontinence as measured by Daily Patient Voiding          Diary   "
31514|NCT02873273|"     The purpose of this study is to determine whether a longer duration, controlled, sustained     release dexamethasone delivery system would be more effective in helping patients with     osteoarthritis reduce their pain, remain functional, and delay their need for knee     replacement.   "
31515|NCT02873260|"     This study will evaluate the ability of a single dose of the live attenuated recombinant     tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against     infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005     vaccine.   "
31516|NCT02873247|"     Patients who test Helicobacter pylori positive, are treated with antibiotics. However, due to     a number of factors (such as unknown treatment compliance, no standardized follow-up, ...), a     relative low eradication-percentage was reported.      Therefore, the investigators want to measure the anticipated improvement in     eradication-percentage due to the standardized treatment schedules (1st line, 2nd line and     further) and the optimized communication with the general practitioner and patients.   "
31517|NCT02873234|"     Chinese Medicine syndrome differentiation has been a prevalent therapy in China for thousands     of years. It is based on patients' symptoms, pulse, tongue and coating on the tongue.     Therefore, the syndrome of patients and corresponding Traditional Chinese Medicine (TCM) may     vary.      This multicenter prospective cohort studies the efficiency and safety of TCM compared with     antidepressants. A total number of 4600 cases with primary depression are expected to be     collected and divided into 3 cohorts based on the patients' requirement and choices. Patients     in one group will receive TCM, and patients in the other two groups will respectively receive     antidepressants only and integrated treatment of TCM and antidepressants. This study has 2     phases: treating period and the follow-up.      The main purpose of this long-term study is to evaluate the efficiency of TCM compared with     antidepressants in reducing relapse and suicide rate, changing lifestyle, improving patient     compliance as well as the safety.   "
31518|NCT02873221|"     This study will evaluate the long-term safety and tolerability of intermittent treatment with     ubrogepant for the acute treatment of migraine over 1 year.   "
31519|NCT02873208|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     ALKS 3831 in subjects with schizophrenia.   "
31520|NCT02873195|"     This randomized phase II trial studies how well atezolizumab and capecitabine with or without     bevacizumab work in treating patients with colorectal cancer that is not responding to     treatment and has spread to other places. Monoclonal antibodies, such as atezolizumab and     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving atezolizumab with capecitabine and bevacizumab may be a better way in     treating colorectal cancer.   "
31524|NCT02873143|"     The prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most     common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared     with other types of knee pain is unknown.      In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on     musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically     diagnosed with PFP. Now, after 5 years, the 504 adolescents, as well as 252 randomly selected     adolescents who did not report knee pain in 2011, will be contacted again to gain insights     into their prognosis.   "
31525|NCT02873130|"     Voice disorders in teachers have a significant impact on communication, quality of life, and     economic costs to the healthcare system. We need to advance the prevention of voice disorders     in teachers by testing an online telepractice model with synchronous (in real-time) and     asynchronous (stored and accessed later) methods. The current study will investigate the     effectiveness of the theoretically-driven Global Voice Prevention Model (GVPM) delivered by     two methods; 1) online telepractice (synchronous and asynchronous) and 2) traditional,     in-person for vocally healthy physical education and vocal music student teachers.     Effectiveness of the model will be assessed by voice-related measures captured daily on a     smartphone app during student teaching, matching the asynchronous aspects of the telepractice     model and representing the effects of vocal loading from teaching.   "
31526|NCT02873117|"     This is a multicenter, cohort study based on medico-administrative data from pathology     laboratory registries and drug reimbursement files (CNAM-TS).   "
31527|NCT02873104|"     To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for     circumferential reduction.   "
31528|NCT02873091|"     Sixteen million babies were born in 2010, approximately half were by cesarean. Labor     analgesia should be the first choice for these parturients based on the consideration of     security and humanization. However this labor analgesia rate is quite low in China (<5%)     while in western country, this rate is up to 60%. Programmed intermittent epidural bolus     (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically     compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia     (PCEA) which is used most commonly. In that study, they reported less total local anesthetic     consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB     technique. In China, multiple factors contribute to the reasons of low labor analgesia rate.     From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to     the symptoms of motor block, such as inability to move their legs distressing, both are     important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore,     in this clinical trial, we plan to find a safer and more effective regimen for labor     analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used     Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.   "
31529|NCT02873078|"     This randomized controlled study aims to evaluate the efficacy of exposure-based     Internet-delivered cognitive behavior therapy for children 8-12 years with Functional     Abdominal Pain Disorders. The children participate along with their parents, who will also     receive specific modules with information on how to support their children in the treatment.     Predictors and mediators for treatment effects will be studied as well as the cost     effectiveness of the intervention.   "
31530|NCT02873065|"     This study compared efficacy and safety of Ilaprazole based triple regimen therapy including     Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first     line eradication treatment of H.pylori   "
31533|NCT02873026|"     Eye trauma is a leading cause of blindness and visual impairment. Penetrating injuries of the     eye are more likely to result in poor vision and the main cause of this is a scarring     response on the retina (proliferative vitreoretinopathy, PVR) The purpose of this study is to     investigate the potential of an anti-inflammatory treatment (triamcinolone acetonide) to     improve the outcome of surgery in eyes that have suffered severe trauma.There is good     evidence from laboratory studies that additional steroid treatment into and around the eye at     the time of surgery could reduce scarring by reducing inflammation and improve visual     outcomes.   "
31534|NCT02873013|"     This study will target patients who have received a histopathological diagnosis of prostate     cancer and who are undergoing treatment in various forms, including active PSA surveillance,     surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. The study will survey     information about the patient at time of diagnosis, clinical staging, details of initial     treatment, status of disease progression, and prognosis at the end point of the study. The     purpose of the study is to clarify distribution of staging, the actual status of treatment     choices and treatment outcomes.   "
31535|NCT02873000|"     To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With     Shortness of Breath.   "
31536|NCT02872987|"     The GMALL registry serves the purpose of ALL research and quality assurance. The Registry     collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical     routine, whether or not the patient is treated within a clinical trial.   "
31537|NCT02872974|"     MySweetHeart Cohort is an observational study to assess the effect of gestational diabetes     mellitus (GDM) on early life offspring's cardiovascular health.      The primary objective is to assess the effect of GDM on the surrogate markers of     cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical     atherosclerosis). The secondary objective is to assess the effect of GDM on the     cardiovascular structure and function during the fetal period and neonatal adverse     cardiovascular risk factors.      The main hypothesis is that offspring of women with GDM have a larger LVMI and a larger cIMT     at birth (primary outcomes) compared with offspring of women without GDM. Further, other     hypotheses are that offspring of women with GDM have more foetal cardiovascular alterations     and adverse neonatal cardio-metabolic risk factors (secondary outcomes) compared with     offspring of women without GDM.      My SweetHeart Cohort is linked to MySweetHeart Trial, a randomized controlled trial assessing     the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to     improve the cardio-metabolic and mental health of women with GDM and their offspring. The     principal investigators of this trial are Prof Jardena Puder and Dr Antje Horsch from     Lausanne University Hospital.   "
31538|NCT02872961|"     PURPOSE: This study will evaluate the relationships between small intestinal bacterial     overgrowth (SIBO), immune activation, inflammation, and symptoms in pediatric abdominal     pain-related functional gastrointestinal disorders (FGIDs), i.e., irritable bowel syndrome     (IBS), functional dyspepsia (FD), & functional abdominal pain (FAP), to better understand the     role of SIBO in their pathogenesis. DESIGN & PROCEDURES: Cross-sectional study. Subjects:     Patients followed at the UT-Houston Pediatric GI clinic, aged 4-17 years, undergoing     endoscopic evaluation of abdominal pain, meeting Rome III diagnostic criteria for IBS, FD, or     FAP, without evidence of an organic etiology of abdominal pain upon routine laboratory,     radiologic, endoscopic, histologic evaluation. Sample Size: At least 30 patients, ≥ 15 with     SIBO (i.e., positive small bowel aspirate culture and/or glucose breath hydrogen test), and     ≥15 without SIBO. Sample Materials: Small bowel biopsies and aspirates, serum, breath     samples, symptom questionnaire responses. Measures: 1) Immune activation & inflammation -     measured by serum cytokine levels & small intestinal tissue inflammatory cell infiltration &     cytokine levels. 2) Symptoms - measured by Abdominal Pain Index, Wong-Baker FACES™ Pain     Rating Scale, Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III Version. 3)     Small bowel microbiota analysis - assessed by 454 pyrosequencing. RISKS & POTENTIAL BENEFITS:     Aside from the risks associated with routine endoscopy with biopsies, which would occur even     without study enrollment, the risks associated with serum collection, one extra biopsy     specimen collection, small bowel aspirate collection, completion of pain scales/     questionnaires, and the glucose breath hydrogen test for the purposes of the study are     minimal. POTENTIAL IMPACT: This study should yield valuable information regarding the     relationships between SIBO, immune activation, inflammation, and symptoms in pediatric IBS,     FD, and FAP. Potential biomarkers to support the diagnosis of these FGIDs and novel targets     for therapy, such as immune molecules and previously unrecognized bacterial phylotypes and     species possibly contributing to disease pathogenesis, may be identified. Also, determining     the reliability of the glucose breath hydrogen test vs. small bowel aspirate culture in the     diagnosis of SIBO in this setting may enable the physician to avoid invasive and costly     procedures in the diagnostic work-up of children with these FGIDs.   "
31539|NCT02872948|"     The main objective of this study is to estimate the intrinsic diagnostic qualities of the     digital dPCR in the screening of T21 from a multicentrique sample of patients with     pregnancies at high risk of T21 (risk > 1/250).      The profit expected from this technique is to propose to the encircled women a screening more     successful than that of the screening combined(organized) of the 1st quarter, simple of     realization and in a moderate cost. We thus propose here an original alternative(alternate)     method to the exclusive, expensive and binding techniques of top-debit(-flow). The recent     technical improvements and his(her,its) advantages medical - economic allow to envisage a     reliable, strong and long-lasting use of the dPCR in clinical routine in the DPNI of T21 in     most of the laboratories. This pilot project could serve for the later development of a study     of clinical validation multicentrique of large scale(big turntable ladder).   "
31540|NCT02872935|"     In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of     crystalloids, with placing the spinal, along with administering a phenylephrine infusion and     glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and     good intra and post-operative pain relief.   "
31557|NCT02872701|"     This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung     cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission     tomography imaging based on standard of care. This study aims to assess the efficacy of OTL38     and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating     theater, and to assess the safety and tolerability of single intravenous doses of OTL38.   "
31558|NCT02872688|"     The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria     (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects     will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label     and subjects will act as their own controls as the microbiome is unique to individuals.     During the run-in period, subjects will collect two stool samples and complete daily bowel     habit diaries in order to understand usual habits and profile the microbiome for each     subject. 30 subjects will take part in this research study conducted at Nutrasource     Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be     collected at the end of the study and daily bowel habit diaries maintained for the duration     of the study.   "
31541|NCT02872922|"     Endothelium is a cell layer that interposes blood and smooth muscle of vessels. This     biological sensor reacts to physical and chemical stimuli by synthesis and/or liberation of     regulatory substances like nitric oxide (NO), which acts on vascular tone, growth of muscle     cells and platelet aggregation and leukocyte. Clinically, endothelial function measured by     technique flow-mediated dilation (FMD) is a strong predictor of cardiovascular events and     all-cause mortality. Previo study demonstrated that continuous and pulsed therapeutic 1-MHz     ultrasound waveforms improved endothelial function in health volunteers and this vasodilation     persisted for 20 min, which provided them with anti-inflammatory vascular effects. In     subjects with type 2 diabetes (DM2) the chronical hyperglycemia and dyslipidemia reduce NO     bioavailability causing endothelial dysfunction. Low intensity therapeutic ultrasound is an     electrotherapeutic instrument employed in musculoskeletal injuries that promotes     endothelium-dependent vasodilation, and its mechanism of action has not been studied on DM2.     The aim of our study is evaluate endothelial function of patients with DM2 after different     waveforms (placebo, continuous and pulsed) of therapeutic ultrasound. Therapeutic ultrasound     is a electrotherapeutic instrument that can changes arterial endothelial function of subjects     with DM2 because of NO bioavailability increasing, which implies anti-inflammatory and     vasodilatory beneficial alterations for diabetic patients.   "
31542|NCT02872909|"     This study aims to examine whether the pain of topical photodynamic therapy (PDT) is     significantly different when using low irradiance ambulatory light emitting diode (LED)     devices compared with conventional higher irradiance hospital based LED light sources when     used for superficial non-melanoma skin cancer. The investigators are also investigating the     phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.   "
31561|NCT02872649|"     Patients with severe heart failure supported by left ventricular assist device (LVAD) require     adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin     inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation.      In this pilot single-center study, thirty LVAD patients with stable renal function were     scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after     implantation of a HeartWare HVAD system following an open-label balanced parallel group     design.   "
31562|NCT02872636|"     The objective of this feasibility study is to demonstrate the safety and feasibility of using     an investigational extracorporeal system and catheter to filter hemorrhagic cerebrospinal     fluid (CSF) post subarachnoid hemorrhage (SAH) treatment, and reintroduce the CSF via the     same catheter.   "
31543|NCT02872896|"     Subjects will first have a blood pressure reading recorded on both arms using a non-invasive     blood pressure monitoring (NIBP) cuff in the preoperative area. Then blood pressure will be     recorded using the ClearSight monitor on each hand over a one-minute period. If mean arterial     pressure (MAP) as assessed by either the noninvasive blood pressure (NIBP) monitoring cuff or     the ClearSight system differs by more than 10% from arm to arm, the subject will be excluded     from the study.      Before induction of anesthesia, the subject will be randomized to either:      ClearSight group + usual clinical care: Information from ClearSight monitor will be available     to the clinicians. According to ASA guidelines, usual blood pressure monitoring includes     non-invasive blood pressure measurements every 5 minutes during a surgical case.      Non-ClearSight group (blinded) + usual clinical care: Information from ClearSight monitor     will not be available to the clinicians.      Both patient groups will have continuous ClearSight monitoring and non-invasive blood     pressure monitoring every 5 minutes. The difference will be in the intervention group data     from the monitor will be available to the clinicians in the operating room, but in the     control group data from the ClearSight monitor will not be available (blinded) to the     clinicians. Regardless of the study group assignment, second-by-second ClearSight monitor     continuous blood pressure data will be recorded for each study patient and will be used for     analysis.      The morning of post-operative day 3 the subject will be given the QoR-15 questionnaire and     will complete POMS morbidity surveys.   "
31544|NCT02872883|"     This is a pilot study that will eventually result in a main randomised controlled trial that     will look at what management is associated with a higher rate of normal birth and a lower     rate of chorioamnionitis (maternal infection) when women break their waters but labour does     not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks     gestation) is a physiological event that happens during labour. However, according to Gunn et     al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time     between the rupture and the onset of labour is called latent phase and time wise is variable.      Studies have showed no statistically significant differences in terms of neonatal infection     or chorioamnionitis when the investigators induce labour with prostaglandins compared to when     labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number of     confounding factors that might relate to the incidence of chorioamnionitis (maternal     infection), the strongest predictor was having more than 8 vaginal examinations since the     rupture of membranes and before delivery which was a stronger predictor than the duration of     the latent phase. It is thought that by reducing the number of internal examinations,     chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main     RCT will compare clinical outcomes and maternal satisfaction when women consent to be     randomized to four groups: (1) Active management and routine internal examinations during     labour, (2) Active management and reduced internal examinations, (3) Expectant management and     routine internal examinations, (4) Expectant management and reduced internal examinations.      This application seeks ethics approval for the pilot phase to ensure that a definitive study     can be undertaken appropriately. It is important to test that all the components work well     individually and as a whole, to estimate sample size and ultimately to test the integrity of     the research protocol before embarking on the main trial.   "
31545|NCT02872870|"     This study will help to better characterize oral and written language disorders and determine     if these disorders are continuous or not. The participants ( dyslexic and dysphasic patients     and control adults) will carry out an auditory lexical decision task during which an     electroencephalogram (EEG) will be recorded.   "
31546|NCT02872857|"     The purpose of this study is to examine the effects of the study drug--Galantamine—on     patients with subarachnoid hemorrhage (SAH). The study will examine how patients with SAH     will tolerate the study drug and how it may improve brain functioning in patients after SAH.   "
31547|NCT02872831|"     The primary objective of this proposed prospective randomized, multi-center study is to     evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to     compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle     aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in     the pancreas and gastrointestinal tract. The secondary objective is to determine the ability     of the 22G SharkCore™ needle system to yield histologic tissue.   "
31548|NCT02872818|"     The purpose of the study is to determine apoptotic signaling pathways such as Survivin,     Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial     hyperplasia after metformin and medroxyprogesterone acetate administration.   "
31549|NCT02872805|"     One of the distinct challenges faced by emerging adults with HIV is the transition of their     care from their long-term pediatric HIV provider to treatment within an adult HIV program.     The consequences of an unsuccessful transition can range from difficult to catastrophic. The     Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a randomized trial of     innovative interventions targeting gaps in care that are major drivers of loss in the ART     continuum of care cascade among adolescents and increasing missed opportunities to engage     adolescents into care. The specific aims of ADAPT are: 1. To inform strategies for transition     services in resource-limited settings; 2. To examine the developmental, clinical, and other     factors that predict a successful transition; and, 3. To gain fundamental insight on     implementation barriers among African adolescents through the application of the ego-network     defined social support that will inform targets for structured intervention. ADAPT will be     conducted in central, southern, and northern Nigeria at selected PEPFAR sites supported by     the Institute of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six     focus groups including: Adolescent patients, parents and health care providers. To address     aim 2, the investigators will conduct a cluster randomized clinical trial. The two     interventions are based on prior evidence-informed engagement strategies: 1) educational     interventions and 2) interventions that use a peer transition advocate who prepares the     adolescent and their parents for transition. The investigators will enroll 300 patients (150     patients in each arm). The sites will be randomized to an intervention. The primary outcome     will be successful transition, keeping two follow-up appointments within a nine months period     following transition. Secondary outcomes, as recommended by focus group participants will     also be measured. To examine the potential role of social network components and     characteristics of both egos and alters on primary outcomes, a Generalized Estimating     Equation (GEE) approach will be used to explore the associations between primary outcomes and     factors at the ego, alter, and network levels. The finding from this study will guide     institution of best practices for transitioning adolescents in Nigeria and other countries     lower and middle income countries with similar challenges and potential for high impact.   "
31593|NCT02872233|"     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection     Factor (SPF) on the skin of human subjects.   "
31650|NCT02871479|"     This trial will be a single-blind, randomized, placebo-controlled, safety, tolerability and     efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment     regimen when administered daily for up to 28 days to patients at least 17 years of age, with     atopic dermatitis.   "
31551|NCT02872779|"     The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and     clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA),     circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate     the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that     early evaluation could be clinically relevant. Indeed, early tumoral response seems to be     correlated to overall survival. Moreover, post-operative morbidity increases with the number     of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy     regimens when response appears to be insufficient.      The aim of the present study is to evaluate, in a prospective cohort of patients treated with     systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy     as first line treatment for a mCRC, the correlation between early variations of circulating     tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3     months objective response as defined in the RECIST 1.1 guideline.   "
31552|NCT02872766|"     43 Subjects (43 eyes) qualified for participation will undergo the required screening     procedures to determine study eligibility. The surgical protocol involves applying riboflavin     0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA light with the KXL     II system according to the programmed treatment pattern.      All use of the KXL II system will be in accordance with the general instructions in the     operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24     months after treatment.      Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual     acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS),     will be obtained at baseline and at appropriate times after the treatment.   "
31553|NCT02872753|"     The rational of intra-articular Platelet-rich Plasma (PRP) administration is based on both     the biological and mechanical properties of PRP, which exerts positive effects on the     modulation of the entire joint environment through the local release of a milieau of growth     factors and other bioactive molecules that act on all the articular tissues, contributing to     minimize the inflammatory distress following surgery.      The aim of the present double blind controlled study is to evaluate the effects in terms of     pain control and functional recovery provided by a single intra-operative injection of PRP     performed at the end of arthroscopic partial meniscectomy.      Patients included in this trial will be randomized in two treatment groups: the first one     will receive a single injection of 3-5 cc of PRP (which will be produced directly in the     operating room (OR) using a dedicated centrifuge) at the end of the arthroscopic     meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure     the double blinding of the trial all the patients enrolled will undergo blood harvesting     before anesthesia, and PRP will be produced just for the patients included in PRP group.      All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by     the following evaluation tools: IKDC (International Knee Documentation Committee) subjective,     VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and     Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and     at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the     operated and contralateral knee were documented; also in addition, the trans-patellar     circumference of both knees was registered to assess the trend of knee swelling over time.      Drugs assumption during the follow-up period will be recorded for each patient. All eventual     adverse events occurred during the follow-up period will be registered.   "
31554|NCT02872740|"     Title: Embolization of Gastric Arterial Supply for Weight Loss      Sample size:      10 patients      Study Population: Morbidly obese patients who were seen by the bariatric surgery program at     Toronto Western Hospital but are either not interested or not eligible for surgery.      Study Design:      Single center, randomized, prospective, non-blinded pilot study.      Study Duration:      12 months (November 2015 - December 2015).      Agent:      150-250 micron polyvinyl alcohol particles      Primary objective:      To further evaluate the safety of embolization of the left gastric and gastroepiploic     arteries. To determine if either or both will result in significant weight loss and decrease     in waist circumference among obese patients.      Primary objective measure:      The number of adverse events in a 1 year period will be recorded. The weight change from     baseline will be recorded.   "
31555|NCT02872727|"     The object of this new project is to proceed with investigations with the employees of the     cohort for the first study so as to obtain a remote evolution (5 years) of their respiratory     function while measuring their nanoparticle exposure. This will enable us to assess the     possible link between exposure and respiratory function evolution in the employees   "
31556|NCT02872714|"     The purpose of this study is to evaluate the overall response rate (ORR) of INCB054828 as a     monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma     harboring FGF/FGFR alterations.   "
31661|NCT02871336|"     This data base has been set in order to gather medical and surgical information from patients     who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance     Publique des Hôpitaux de Marseille, France.   "
31559|NCT02872675|"     The current study aims to explore the role of prebiotic supplementation in adults with and     without Asthma/Exercise-Induced Bronchoconstriction (A/EIB). All participants will be asked     to consume a prebiotic supplement, and a placebo, each for a total duration of four weeks,     separated by a four-week wash out period. The investigators hypothesise that improvements in     pulmonary function observed following prebiotic supplementation will be attributed to gut     microbiota mediated improvements in host immune function.   "
31560|NCT02872662|"     This study aims to develop highly sensitive methods for early detection of relapse based on     the patients unique mutations. Initially, a mutational screen is being performed. Primers     directed against these mutations will be constructed and presence of mutations will be     followed in bone marrow and blood frequently after transplantation.   "
31563|NCT02872623|"     Early diagnosis of tumors of the small intestine is a challenge for clinicians and for     radiologists. The detection of tumors of the small intestine is a field in which the video     capsule endoscopy has the lowest performance.      The entero-CT with enteroclysis is the imaging technique used primarily to explore patients     with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis     has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the     patient and it is a complicated examination in terms of logistics with necessity of specific     equipment to insert the nasojejunal tube.      MRI has been proposed as an alternative imaging technique and satisfactory results have been     reported with the MRI enteroclysis. However, this technique has several disadvantages related     to nasojejunal tube insertion and the necessity of equipment compatible with the high     magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the     small intestine by ingestion of large quantities of a liquid, has a major and undisputed role     in the exploration of Crohn's disease of the small bowel. However, its capacity for     distension of the small intestine for optimal tumor detection is questioned and its role in     tumor detection is largely unknown.   "
31564|NCT02872610|"     The objective of the SOS-trial is to examine if an online self-help intervention is effective     in reducing suicidal thoughts among people at risk of suicide. The SOS-trial is a randomized,     wait-list controlled trial with 1:1 allocation ratio. A total of 438 people with suicidal     thoughts will be allocated to the intervention condition (N=219) or the control condition     (N=219). The intervention condition consists of a six-week internet-based self-help therapy     intervention. The control condition consists of a waiting list assignment for 32 weeks. The     primary hypothesis is that the intervention is superior to the control condition in reducing     suicidal thoughts at post-test (6 weeks). The SOS-trial is a partial replication of a     previously conducted Dutch trial.   "
31565|NCT02872597|"     This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to     standard therapy in the treatment of severe asthma attacks in children admitted to the     Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and     half will receive an inhaled placebo.   "
31566|NCT02872584|"     Free fatty acid index will be measured in patients before and 1 month after high dose     prednisone.   "
31567|NCT02872571|"     The liver may not be an optimal site for islet transplantation due to obstacles by an instant     blood-mediated inflammatory response, and low revascularization of transplanted islets.     Therefore, intramuscular islet transplantation offers an attractive alternative, based on its     simplicity, enabling easier access for noninvasive graft imaging and cell explantation.   "
31568|NCT02872558|"     This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis     Media in the Emergency Department setting.   "
31569|NCT02872545|"     The purpose is to compare percentages of myocardial segments showing attenuation in patients     in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or     semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.      The hypothesis is that the percentage of myocardial segments with attenuation is     significantly lower when acquisitions are made in forward tilted position (biker position).      The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to     attenuation artifacts (anterior, apical and inferobasal regions).   "
31570|NCT02872532|"     This protocol is being designed to offer testicular tissue cryopreservation to male pediatric     patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery,     chemotherapy or radiation therapy that may cause loss of reproductive potential.   "
31571|NCT02872519|"     This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG     [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients     with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as     18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has     spread.   "
31572|NCT02872506|"     Compare the quality of life at 6 months between 2 populations of patients followed for     terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.   "
31573|NCT02872493|"     The purpose of this study is to determine whether or not the total length of small intestine     effects outcomes after bariatric surgery in a cohort of patients preoperatively and up to ten     years postoperatively. Roux-en-Y gastric bypass and vertical sleeve gastrectomy will be the     surgical groups in this study. We aim to determine if bowel length has a significant effect     on long term weight loss or other nutritional deficiencies in this bariatric cohort.   "
31574|NCT02872480|"     Healthy (non-injured) and concussed college-aged participants will complete two testing     sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a     progressive exercise session to establish symptom exacerbation or maximal exercise capacity.     Individuals randomized to the control group will receive no intervention between sessions,     while individuals randomized to the intervention group will complete 30 minutes of stationary     bike exercise at least 3 days/week.   "
31575|NCT02872467|"     The purpose of this research is to study the effects of nasal oxytocin administration on     maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with     prenatal use of cocaine during the current pregnancy will be studied at 3-6 months     postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice     daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected     is confidential.   "
31594|NCT02872220|"     The primary objective of this tudy was to evaluate the potential of photoallergy of of sun     care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104     application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed     by irradiation with UV A and UVB.      The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002,     and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse     events (AEs) throughout the study.   "
31595|NCT02872207|"     The objective of this study was to compare the human eye stinging potential of experimental     formulas and an industry standard shampoo mixture. The study was conducted under the     supervision of a Board Certified Ophthalmologist.   "
33078|NCT02852798|"     This is a clinical study of Apatinib Mesylate Tablets combined with docetaxel monotherapy as     second-line therapy of advanced EGFR wild-type, non-squamous, non-small-cell lung cancer.   "
31576|NCT02872454|"     Major depression is the leading cause of disability in the United States and is a major     contributor to suicide, a leading cause of premature death. The majority of individuals with     depression do not receive adequate pharmacologic or psychotherapeutic treatment due to     difficulty accessing services or stopping treatment due to side effects, non-response, or the     stigma associated with attending mental health clinic visits. Mobile health information     technology services, such as text messaging, have the potential to provide effective     self-management support for depression to nearly every adult in the US with depression.     Guided self-help via text messaging has been shown to be effective for improving a range of     health behaviors as well as symptoms of depression. However, previously studied depression     text messaging services have not utilized the breadth of psychotherapeutic techniques shown     to be effective for depression nor have they attempted to tailor the psychotherapeutic     content to the individual in order to improve acceptability and outcomes. Advanced artificial     intelligence methods (e.g., reinforcement learning) offers the capability to weed out     ineffective messages and to target messages to individuals in order to substantially improve     program effectiveness. This pilot study is the first step in towards developing an     artificially intelligent text message service for depression.      The specific aims of the study are to: 1) demonstrate the feasibility of recruiting and     enrolling participants from the general population of US adults and delivering a     text-messaging intervention for depression, 2) determine whether there are differences in the     perceived helpfulness of messages derived from different psychotherapeutic treatment     modalities, and whether these differences are moderated by participant characteristics (e.g.,     age, gender, depression symptom severity), 3) determine whether messages derived from     different psychotherapeutic treatment modalities or their perceived helpfulness are     associated with changes in depression symptoms, and whether these relationships are moderated     by participant characteristics.   "
31577|NCT02872441|"     IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by     inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells     predominance, and fibrosis in involved tissues. Despite a preferential involvement of     exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are     usually effective in this indication, but with poor tolerance and a high risk of relapse     after decrease or withdrawal of this treatment. In this context, identification of new     therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD remains     actually unknown. In previous studies, it has been shown that T follicular Helper (Tfh) cells     are expanded in the blood of these patients. Tfh cells have an important role in the     formation of germinal centers (GCs), and ectopic GCs have been found in tissues of patients     with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B cell     compartment. In this context, this population could have an important contribution in the     pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.      TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This     study is an exploratory prospective multicentric study. Thirty patients with a suspected     diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in the     study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic biopsy     sample, will be obtained in this study. The results obtained in patients with a confirmed     diagnosis of IgG4-RD ( IgG4-RD group ) will be compared to results of patients with another     diagnosis ( control group ). Main objective of the study is to show by confocal microscopy     an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue of IgG4-RD patients     compared to controls. Secondary objectives include : tissue analysis of Tfh subsets (Tfh1,     Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory cells, and T helper     cells (Th1, Th2, Th17); correlation between tissue and circulating biomarkers; tissue     proteomic analysis; and functional analysis of circulating Tfh cells after sorting of these     cells and co-culture tests with autologous naive B cells. All these results will be compared     between the  IgG4-RD group  and the  control group . This study should clarify the role     of these Tfh populations in IgG4-RD, identify diagnostic tissue and blood biomarkers, and     identify therapeutic targets in these patients.   "
31578|NCT02872428|"     THIS IS THE SECOND PART OF A 2-PART STUDY. The purpose of the first part of this study was to     determine the safety and tolerability of ascending doses of valproic acid (also known as     Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250     mg/kg in healthy subjects.      ID: VPA-C-002      The second part of the study will also be to determine the safety and tolerability of single     ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic     shock.   "
31579|NCT02872415|"     Numerous experimental and clinical studies have shown that preterm neonates are particularly     sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each     situation causing pain or discomfort can alter their development and cause short term     cardiovascular consequences but also have long-term neurocognitive influences. Repetitive     procedural pain can also lead to changes in the pain sensitivity threshold therefore. The     most common painful procedures are lancing for blood glucose testing. In adults, infants and     term newborns, forearm blood glucose testing has been demonstrated to be less painful than     conventional sites (heel, fingers). But data is lacking in preterm neonates.      The primary purpose of this study is to demonstrate a significant reduction in pain response     during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born     up to 32 weeks gestation.      This study is an interventional multicenter (3 centers), randomized, double bind trial with a     cross over assignment. 60 premature neonates born between 23 to 32 weeks.      Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose     pricks will be included. The different sites will be randomly successively tested.   "
31580|NCT02872402|"     The goal of the study is to investigate the effect of a lifestyle intervention program     (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on     minimizing postpartum weight retention among women with recent GDM.   "
31581|NCT02872389|"     The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and     desflurane at equal minimum alveolar concentrations using power spectral analysis of the     electroencephalogram.   "
31608|NCT02872038|"     The purpose of this study is to compare the efficacy of empirical antibiotics of     CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy     versus combination of cefazolin and ceftazidime. Patients were randomized to be administered     either intraperitoneal cefepime 1 g loading then 250 mg all exchanges (treatment group) or     cefazolin and ceftazidime (control group) in the same dose.   "
31609|NCT02872025|"     This is a pilot study to investigate the change in the immune microenvironment of high risk     ductal carcinoma in situ (DCIS) after short term exposure to pembrolizumab.   "
31787|NCT02869672|"     This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal     Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3     group according to their age, receiving the test vaccine and the control vaccine at the     proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.   "
31582|NCT02872376|"     Anemia is the most common extraintestinal manifestation of IBD, occurring in 6 to 74 percent     of patients. Most cases of anemia in IBD are due to iron deficiency (IDA) and to anemia of     inflammation (AI). Although the ECCO diagnostic criteria for IDA are simple, and iron     supplementation represents a cheap and usually effective treatment, many IBD patients with     IDA are not properly treated. The inconsistent adherence, by many physicians, to treatment     guidelines for IDA in IBD is often motivated by the belief that mild to moderate degrees of     anemia may not have a significant impact on the patient's quality of life or do not represent     the main clinical problem of the patient, that oral iron supplementation may adversely affect     disease activity, and that parenteral iron administration may cause severe side effects. On     this basis, we aim to perform a longitudinal, prospective, observational study whose main     objective is the determination of the prevalence of anemia in IBD patients in Italy.     Secondary objectives of the study are a) to investigate the pathogenesis of anemia in IBD,     with a particular focus on the differential diagnosis between IDA and AI, and how disease     activity, extension or behavior influence the relative frequency of IDA and AI; b) to verify     the adherence to ECCO guidelines for the treatment of IDA in IBD (the proportion of patients     with IDA that receive adequate iron supplementation); c) to administer dedicated     questionnaires to the patients in order to measure the influence of anemia on fatigue and     quality of life among IBD patients.   "
31596|NCT02872194|"     The objective of this study was to compare the human eye stinging potential of experimental     formulas and an industry standard shampoo mixture. The study was conducted under the     supervision of a Board Certified Ophthalmologist. The study design was a three cell, single     blind study. Subjects were given the industry standard shampoo mixture in one eye and an     exploratory sunscreen in the other as according to the randomization schedule.   "
31583|NCT02872363|"     Breast screening is a service offered by the NHS to help detect breast cancer and     precancerous changes early at a time when treatment is more likely to be curative. An     effective service must reach the 'at risk' but asymptomatic population. Breast screening     uptake in London, consistently falls below the national target and is well below the national     average. Uptake in West London is particularly low, with boroughs in Inner North West London     having the some of lowest uptake rates in the country.      Routine text message reminders have proven effective at improving uptake of breast screening     appointments. However little attention is paid to the content of the messages. Previous     studies of text message reminders in other clinical areas have shown that the content of     these messages matters and some text messages are more effective than others.      This protocol describes the design of a randomized controlled trial to investigate the effect     of differently worded text messages on the engagement with breast screening in West London.      Two intervention arms were designed taking into consideration results of a 1000 woman survey     to highlight the behavioural barriers that most predict attendance. The survey tested 15     behavioural constructs and the two that most strongly predicted history of attendance were     used to inform the text message content of the intervention arms for this trial.      To this end, this randomised controlled trial (RCT) will test the current standard practice     text message reminder against two intervention text message trial arms informed by the above     described survey.      The setting is West of London Breast Screening Service and women aged 47-73 who are due for     screening will be randomized to receive one of the three trial arms.      The primary outcome is the difference in uptake between trial arms. Further statistical     analysis will analyse the difference in uptake by age group, deprivation score and previous     attendance status.      Result will inform how small changes to the word content may have significant effects on     attendance at screening mammogram appointments.   "
31584|NCT02872350|"     Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in     premature infants.      The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to     date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of     pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the     diagnosis. The prognostic value of these radiographic findings is currently controversial.      Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to     be considered for some years. It also has other advantages, including that of not being a     radiating examination. Studies on the prognostic value of abdominal ultrasound are rather     few. Moreover, they involve a series of heterogeneous patients in terms of gestational age.     Or the pathophysiology of ECUN in children born at term and in children born prematurely is     not the same.      The objective is to study prospectively the prognostic contribution of abdominal ultrasound     in the ECUN in premature under 33SA.   "
31585|NCT02872337|"     The purpose of this study was to evaluate the efficacy of a one-time, preoperative physical     therapy protocol on postoperative (1) discharge disposition, (2) pain, function and stiffness     and (3) patient satisfaction.   "
31586|NCT02872324|"     Mindfulness is both a natural resource of individuals present in all individuals in varying     degrees characteristic ability of attention to the experience that unfolds moment by moment     without judgment and a practice based on meditation, mindfulness exercises, which aims to     enhance two central skills of mindfulness that are the presence and acceptanc. In the context     of recurrent depression, the practice of mindfulness meditation in the frame of MBCT is     recognized as effective in psychological suffering and relapse. The mechanisms implied in     MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms,     reduction of rumination is a major factor in the action of MBCT, especially for patients with     less than three depressive relapses.      This exploratory research focuses on the impact of mindfulness functioning (mindfulness     resource level at baseline) on the benefits of MBCT for patients with recurrent depressive     disorder.      The objective is to assess whether the level of mindfulness resource of patients with     recurrent depression is a factor contributing to the positive effect of a MBCT applied in     add-on to conventional care.      This objective will be measured by comparing the clinical improvement of patients secondary     to MBCT according to the initial categorization of the mindfulness resource.      Clinical improvement will be more important for patients characterized by a lower initial     level of mindfulness resource.   "
31587|NCT02872311|"     This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the     immune response to consecutive influenza vaccination across 2 seasons. Participants will be     randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will     receive the same vaccination in the second year and the third arm will be randomized again to     1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood     draws for a total of 6 draws over 18 months.   "
31588|NCT02872298|"     Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation     (TLD) Therapy in subjects with severe, refractory asthma.   "
31589|NCT02872285|"     The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC     in patients with moderate plaque-type psoriasis.   "
31647|NCT02871518|"     This is a Phase II trial to study the effectiveness of two cycles versus three cycles of     Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced     Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.   "
31590|NCT02872272|"     The loss of skin barrier function after burn causes increased susceptibility to infections,     which are the leading cause of morbidity and mortality in burn patients. Topical antibiotics     are one part of the therapeutic arsenal available to treat these infections. Pseudomonas     aeruginosa and Staphylococcus aureus are the two major colonizing agents found in this     population of patients.      The use of dressings impregnated with amikacin is a common practice. Actually, there are no     available data on local and systemic effects with this antibiotic. The study of tissue and     plasma pharmacokinetics of amikacin is therefore very important to secure and optimize this     singular use of amikacin and improve the care of burn patients.      The objective of the study is to describe the plasma and tissue pharmacokinetics of amikacin     after dermal administration and impregnated dressing to estimate the pharmacokinetic     parameters and their variability in a burned population.      Secondary objectives are to assess on the one hand the relationship between the effectiveness     of treatment and the concentration of antibiotic at the site of tissue infection, and on the     other hand to assess the relationship between plasma concentration and the toxicity found of     this treatment. We would like also to note the efficacy of the antibiotic treatment in terms     of: need for repeat surgery (new skin graft), healing time and hospital length of stay.      Blood samples and skin biopsies will be made for each patient to day 3 and day 7 after the     start of treatment.      The knowledge about the tissue concentrations obtained and a possible systemic absorption     will then provide additional safety data and optimize the conditions of use of these     dressings (dosage, frequency of administration) for effective treatment and safe.   "
31592|NCT02872246|"     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection     Factor (SPF) on the skin of human subjects.   "
31597|NCT02872181|"     During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to     reduce compression of the major blood vessels by the uterus. Despite this common practice,     there is no conclusive evidence to support this practice. In fact it may even be deleterious     to have women positioned in this position. The aim of the study is to determine whether or     not tilting women to the left during cesarean section (CS) is helpful or detrimental. The     authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed,     is useless for preventing compression of these blood vessels. To investigate this question,     women will be randomly assigned to either be tilted 15 degrees to the left during CS or     positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient     satisfaction, maternal complications, and fetal complications will all be collected and     compared.   "
31598|NCT02872168|"     Recent in-vitro and in-vivo studies performed by one of the investigators (ESO, ICMPE, UPEC,     France) have recently allowed to synthetize a new and easy-to-synthesized chemical compound     of the furosemide (pyridinium furosemide) during furosemide degradation by electro-Fenton or     bioconversion. The biological properties of pyridinium furosemide are currently under     investigation. Furosemide is a diuretics currently used in the treatment of patients with     heart failure. The goal of the investigators is to assay pyridinium furosemide in urine of     patients treated by furosemide to demonstrate that pyridinium is or not a metabolite of     furosemide in humans. This study will contribute to assess the fate of pharmaceutical     residues of furosemide in the environment.   "
31599|NCT02872155|"     This study evaluates if oral hydratation is as effective as endovenous hydratation in the     prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under     study conducting contrasted computed tomography.   "
31600|NCT02872142|"     This is a pilot, phase IIa, prospective, open-label, single-arm study to evaluate disease     progression, forced vital capacity, and the safety and tolerability of plasma exchange (PE)     using Albutein® 5% in subjects with amyotrophic lateral sclerosis (ALS).   "
31601|NCT02872129|"     A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in     western Sweden.      The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming     to investigate the effect of pool exercise and patient education.      The primary aim of the present study is to examine the change of symptoms after 11-12 years     in 166 women with FM or CWP and also investigate predictors of change of symptoms and work     ability.      The 166 women will be asked to participate in the present follow-up study. The follow-up     examination comprises a standardised interview of symptoms and demographic variables, a     battery of self-administered questionnaires and tests of physical function.   "
31602|NCT02872116|"     The main purpose of this study is to compare how long patients with gastric or     gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab     and chemotherapy compared with patients receiving chemotherapy alone.   "
31603|NCT02872103|"     This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the     efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy     treatment.   "
31604|NCT02872090|"     The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to     quantify the possible deleterious effect on the cardiac autonomic nervous system control of     two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one     beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.   "
31605|NCT02872077|"     This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal     abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General     Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment     for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length     of stay.      This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by     means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.   "
31606|NCT02872064|"     Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast     cancer.   "
31607|NCT02872051|"     The purpose of this study is to investigate the efficacy of 1) a stepped mental health care     intervention and 2) an integrated mental health care and vocational rehabilitation     intervention for people on sick leave because of depression and anxiety in Denmark   "
31648|NCT02871505|"     The investigators compare the treatment results and clicical presentations of different     Molecular subtyping of Treponema pallidum   "
31610|NCT02871999|"     Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of     gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or     cell biology. Patients are randomized into 2 groups: The control group receive normal     treatment only, the experimental group receive acupuncture therapy besides normal treatment.     Clinical evaluation is based on the observation of the pain degree and life quality     improvement. Blood biochemistry tests mainly include Prostaglandin     E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide     dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis     factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum     cortisol, estradiol (female), progesterone (female), testosterone (male) etc.   "
31611|NCT02871986|"     The investigators wish to explore the variability of uterine, breast and bone outcome markers     as surrogates to assess the adequacy of exogenous oestrogen replacement in individuals with     hypogonadism.   "
31612|NCT02871973|"     The objective of this research is to conduct a small randomized pilot study to evaluate the     feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary     care setting to enhance parent-child interactions and explore potential impacts on parenting     behaviors.   "
31613|NCT02871960|"     The purpose of this study is to evaluate surgical stress and immune function after robotic     versus laparoscopic colectomy.   "
31614|NCT02871947|"     Severe asthma is a heterogeneous disease characterized by the need for treatment with high     doses of inhaled corticosteroids. It affects 5%-10% of asthmatic patients, although it     accounts for a significant percentage of the consumption of health care resources. Severe     asthma comprises various clinical and pathophysiological phenotypes. In this current study,     we aimed to clinical characteristics and cytokes profile in severe asthma patients.   "
31615|NCT02871934|"     This study will determine whether using a genetic test (for the SLCO1B1 gene) can help     patients and providers choose the right type and dose of cholesterol-lowering statin     medications to lower the risk of cardiovascular disease, while minimizing the muscle pain     side effects that sometimes occur with statins.   "
31616|NCT02871921|"     At each site (OHSU & UM), 180 socially isolated adults 80+ years old will be recruited     through Meals on Wheels People. Participants will be randomized to either the Video Chat     Group or the Control Group. Those in the Video Chat Group will receive a computer for the     duration of the study, which they will use to video chat with study staff for 30 minutes/day     4x/week for 6 months, and then they will video chat 2x/week for another 6 months. Those     assigned to the Control Group will have brief telephone check-ins with study staff once per     week. In-home testing will occur at Baseline, 6 months and 12 months. All participants at     OHSU will have their medication compliance tracked using electronic medication monitoring     devices (MedTracker) and 50% of participants at both OHSU and UM will have MRIs at Baseline     and 6 months, if they are able to safely receive MRIs. All participants at both sites will     contribute saliva for genetic testing, and all video chat sessions will be recorded for     speech and language analysis.   "
31617|NCT02871908|"     The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938     administration for the prevention of diarrhea and AAD in children.   "
31618|NCT02871895|"     In 2004, the Surviving Sepsis Campaign (SSC) introduced guidelines for the management of     severe sepsis and septic shock, as well as strategies for bedside implementation. The     treatment recommendations were organized in two bundles. In an international study, enrolling     adult patients with severe sepsis admitted to these intensive care units, investigators found     that while mortality from severe sepsis is high (44.5%), compliance with resuscitation and     management bundles is generally poor in much of Asia. Investigators need to identify the     patients at risk for high in-hospital mortality in order to take appropriate steps.      From their past studies, investigators found that sepsis involved inflammation and     coagulation. The multiple organ involvement was associated with interaction of novel     biomarkers such as cytokines. There is limited data regarding comparing and application of     biomarkers of different characteristic on sepsis treatment. A simultaneous detection of     multiple cytokines may provide significant prognostic information. For other biomarkers,     promising observation data have been put forward, but their potential needs to be evaluated     in large-scale, well-designed prospective intervention studies before clinical use can be     recommended. Besides many clinical studies on biomarkers were confounded by its lack of     standard bundle care for severe sepsis patient.      Here investigators performed a systematic study aimed at evaluating        1. the individual and combined diagnostic accuracy of biomarkers for predicting mortality;        2. whether trend change in biomarker level more useful for above prediction;        3. which biomarker or biomarker combination checked can predict patients at risk of          evolving with severe organ dysfunctions.   "
31619|NCT02871882|"     To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity,     postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum     FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on     therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in     combination with metformin.   "
31620|NCT02871869|"     Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL),     has great heterogeneity in clinical manifestations, histological morphology and prognosis.     R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the     gold therapeutic criteria for patients with NHL, and it is also used as the first-line     treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive     complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and     secondary drug tolerance. This study aimed to explore whether Cinobufacini Tablets had     synergistic effect in the treatment of DLBCL, and whether its action was in close association     with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse     reactions induced by Cinobufacini Tablets during treatment.   "
31621|NCT02871856|"     People who may be at increased risk of lung cancer due to age and smoking history will be     invited to participate in this international study to determine the best way of using     computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show     that CT screening (screening tests can find diseases early, when they're easier to treat) can     reduce deaths from lung cancer and this study will help determine who is most likely benefit     from screening.   "
31622|NCT02871843|"     This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By     add-on what is meant is that the experimental intravenous therapy, RRx-001, is combined or     added on to standard of care. In newly diagnosed GBM standard of care consists of     radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by     maintenance TMZ given until the tumor progresses or worsens. By maintenance therapy what is     meant is that TMZ is given less frequently to prolong or extend the time during which the     tumor remains stable.      G-FORCE-1 will be conducted in two parts; in the first part of the study (Dose Escalation,     Part A) patients will be entered or assigned sequentially (that is consecutively) to     gradually escalating or increasing doses of RRx-001 after patients have been entered on the     previous dose until such time as it is no longer tolerated. At each dose level, a separate     cohort or small group of at least 3 evaluable patients will be treated. RRx-001 will be     administered by intravenous infusion (in other words, by slow injection in the veins) over     30-45 minutes once weekly during radiotherapy for 6 weeks followed by the FDA-approved     chemotherapy, temozolomide (TMZ) alone for up to 6 months or longer.      In the second part of this study (Part B), new groups or cohorts of patients will receive     RRx-001 at the dose established in Part A by intravenous infusion over 30-45 minutes once     weekly during radiotherapy for 6 weeks. Then, after a 4-6 weeks break, each cohort will     receive increasing doses of RRx-001 and temozolomide (in other words, a double dose     escalation) to establish an acceptable safety and activity window, in other words, a dose     range that is relatively free of toxicity as well as active against the tumor, although the     primary purpose of this study is to assess or evaluate safety.      The reason or rationale to add on RRx-001 to radiotherapy and TMZ, which is described in     more detail below on this page, is as follows: RRx-001 is a radiosensitizer and a     chemosensitizer, which means that experimentally it increases the activity of radiation and     chemotherapy in tumors. In addition, in other ongoing clinical trials, patients have     experienced minimal toxicity or side effects with RRx-001 alone and also in combination with     radiation in the brain; therefore, the hope is that RRx-001 will synergize or combine well     with radiotherapy and TMZ in GBM without adding toxicity   "
31623|NCT02871830|"     Children and young people are recommended to undertake at least 60 minutes of moderate to     vigorous intensity physical activity each day. However recent findings have indicated that     only 51% of children aged 7 years were meeting these guidelines. Previous research has also     highlighted girls are significantly less active than. Furthermore, children living in     Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here     reaching the recommended ≥ 60 minutes a day. The development of interventions which can     successfully increase levels of physical activity in adolescent girls in Northern Ireland is     of key importance. The aim of this intervention is to investigate whether or not girls (aged     11-13 years) can increase their daily levels of physical activity over a 12 week period by     taking part in a school-based brisk walking intervention. The impact of participating in a     school-based brisk walking intervention on a range of other outcome measures will also be     investigated. A total sample of 200 adolescent females will be recruited onto the study, with     recruitment of participants taking place at the school level. Following written consent from     parents/guardians and assent from participants, participants will be randomised at the school     level to either participate in the walking intervention or to act as controls. Objective     physical activity will be assessed at 3 time points using an Actigraph accelerometer. At     baseline, post-intervention (12 weeks) and follow up (4 months post-intervention)     participants will also undergo measurements of height, weight, waist and hip circumference,     bloody pressure, and cardiorespiratory fitness. Participants will also complete     questionnaires assessing levels of physical activity and a number of psychosocial variables     at each time point. Following completion of follow up measurements, a sub-sample of     participants (n=45) will be invited to take part in focus groups to evaluate their     experiences of the intervention.   "
31624|NCT02871817|"     The CLEAR study is testing the level of agreement between in office visual acuity and Amsler     grid testing using a mobile vision testing application, Paxos Checkup Study and standard in     office methods. In addition the percent of patients able to successfully complete home     testing on the digital device will be assessed.   "
31625|NCT02871804|"     Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein     after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together     with the pancreas).   "
31626|NCT02871791|"     This research study is studying a combination of targeted therapy and hormonal therapy as a     possible treatment for breast cancer that has spread to other places in the body and is     hormone receptor positive (HR+) and HER2-negative.      The names of the study interventions involved in this study are:        -  Palbociclib        -  Everolimus        -  Exemestane   "
31627|NCT02871778|"     To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and     the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with     primary ciliary dyskinesia (PCD).   "
31628|NCT02871765|"     The objective of this study is to evaluate an educational program for Atrial Fibrillation     patients under Warfarin treatment regarding to patients' knowledge of Warfarin, related life     distresses and quality of life.   "
31629|NCT02871752|"     We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR)     on positive and negative psychological responses to active surveillance (AS) and AS     adherence, with a sample of men on AS and their spouses.   "
31630|NCT02871739|"     The Health Decision Sciences Center (HDSC) staff has deployed different approaches to     training clinicians to engage patients in shared decision making for common medical tests and     treatments. The purpose of the study is to compare the effectiveness of shared decision     making (SDM) skills training courses using standardized patient interactions (SPI) and     written evaluations.   "
31631|NCT02871726|"     The commonly used diagnostic procedure for prostate cancer, a transrectal ultrasound     (TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially     clustered, rather than uniformly distributed, and do not accurately follow the recommended,     sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping     of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or     target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are     poorly targeted and their spatial mapping remains subjective.   "
31632|NCT02871713|"     Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her     baby and may contribute to developing long term pain and disability. Women having a CD     receive pain medication (morphine) as part of their spinal anesthetic to help with pain     relief after surgery. Morphine works well however has several side effects such as nausea,     vomiting and itching which may be severe enough to make it difficult to care for herself and     her new baby. In some cases, morphine causes difficulty in passing urine within first     24-hours of the CD requiring catheterization and thus restricting mobilization. The quadratus     lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution to numb the     nerves carrying pain sensation from surgical incision site. QLB may be able to provide     effective pain control without the side-effects associated with the spinal morphine. This     study is to determine if women receiving QLB have as good pain control with fewer side     effects than those who do receive the spinal morphine. Adequate pain control will be assessed     by their pain scores and recovery in the 24 to 48 hours after CD. The side effect profile of     the two techniques, quality of recovery and long term impact will also be compared during     this study.      In addition, we would like to compare the patients who received both analgesic regimens (ITM     and QLB) with patients who received only one analgesic intervention (i.e. either ITM or QLB).     Further, the study will help us answer if combining the two analgesic interventions if     beneficial or not.   "
31633|NCT02871700|"     The specific aims of this study will be to:        1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy          (MT) versus a control intervention on motor and functional outcomes of stroke patients.        2. compare the mechanisms and changes in cortical neural activity after AOT, MT, and          control intervention by using magnetoencephalography (MEG).        3. determine the correlations between neural activation changes and clinical outcomes after          AOT and MT.        4. identify who are the potential good responders to AOT and MT.   "
31634|NCT02871687|"     The purpose of this research protocol is to determine if the same effects are observed in     vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the     widely used statin class of medications on the mineralocorticoid pathway would likely have     significant clinical implications on the future management of hypertension and other     cardiovascular disease given the known pleiotropy of aldosterone action.   "
31635|NCT02871674|"     The study aims to implement and evaluate an RCT of behavioural sleep interventions for     children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to     address the following questions:        1. To what extent can a behavioural intervention improve sleep difficulties and increase          sleep duration in children with ADHD?        2. To what extent do intervention-induced changes in sleep for children or primary          caregivers (women) account for any changes in ADHD symptoms?   "
31636|NCT02871661|"     INTRODUCTION: Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a     negative impact over quality of life in women with this diagnose. The existing treatments,     however, are manifold but insufficient. This study aims to verify the effectiveness of     kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia.     METHODS: A single-blind randomized controlled trial will examine 58 women, divided into three     treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline),     amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline     hydrochloride associated with electrotherapy (interferential current). Exclusion criteria     are: presence of infections or genital cancers, chronic degenerative diseases; younger than     18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic     floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride and     being pacemakers use. The parameters analyzed before and after treatment will be: muscle     volume of the anus elevator and perfusion of the pudendal artery obtained with 3D ultrasound,     subjective pain in vaginal intercourse (visual analog scale), monthly frequency of vaginal     intercourse, pain referred within vulvar touch on physical examination (swab test from zero     to 10) and female sexual function (Female Sexual Function questionnaire - FSFI). There will     be a follow up of subjective pain in vaginal intercourse and monthly frequency of vaginal     intercourse obtained by telephone contact with the voluntary on one, six and twelve months     after the end of interventions. The data will be analyzed using Chi-square test of Pearson,     Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared using the     Wilcoxon test (related samples) and McNemar (effect of the intervention), considering     statistical significance level of 5%. The software used is the statistical analysis software     (SAS) - Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003 and Statistical     Package for the Social Sciences (SPSS) -Release 17.0.   "
31637|NCT02871648|"     The purpose of this research protocol is to determine if the same effects are observed in     vivo in humans using a similar approach. Demonstrating that mineralocorticoid acts on zona     glomerulosa cells to regulate aldosterone production in a short feedback loop would provide     important insight into hormone regulation, and explain variability in pathophysiologic states     such as hypertension and cardiovascular diseases.   "
31638|NCT02871635|"     Primary Objective:      The primary objective of this trial is to compare the clinical efficacy of BI 695501 with     EU-approved Humira® in patients with active Crohn's disease (CD).      Secondary Objectives:      The secondary objectives of this trial are to compare the efficacy and safety of BI 695501     with EU-approved Humira® across the induction and maintenance phases.   "
31639|NCT02871622|"     Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35     International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical     practice and will be followed for 2 years for data collection. Major adverse cardiac events     (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM     arm of the LEADERS trial.   "
31640|NCT02871609|"     This study is performed to analyze various aspects of biofilms on ureteral stents in a     longterm setting.   "
31641|NCT02871596|"     The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol     blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal     microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace     analysis) and fecal microbiota composition (assessed by next generation sequencing).   "
31642|NCT02871583|"     The aim of the present prospective controlled study is to compare the trunk muscle strength,     quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.   "
31643|NCT02871570|"     The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK     and safety.   "
31644|NCT02871557|"     This was a prospective multicenter cohort study of elderly people admitted to the acute care     for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse     outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%).   "
31645|NCT02871544|"     Objective: to clarify the predictive value of brain natriuretic peptide (BNP) in combination     with neutrophil gelatinase associated lipocalin (NGAL) for the prognosis of patients with     sepsis.   "
31646|NCT02871531|"     Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy     (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and     patient quality of life in patients with extended criteria.      Methods: A prospective, randomized, controlled trial will be conducted with 178 patients     presenting at St. Michael's Hospital with primary retinal detachment (RD). Inclusion criteria     include: a single or multiple retinal tears in detached retina between 7 and 5 o'clock being     of any size and any distance apart from each other, including giant retinal tears with     inferior aspect above 5 and 7 o'clock, RD with no identifiable tear but where suspected tear     is between 7 and 5 o'clock, retinoschisis with RD if tears are located between 7 and 5     o'clock, mild proliferative vitreoretinopathy, none or mild vitreous hemorrhage. Patients     will be excluded if there is a small retinal tear or multiple tears less than 30o apart     between 8 and 4 o'clock in detached retina, retinal tear in detached retina between 5 and 7     o'clock, <18 years old, inability to read English, mental incapacity, previous history of RD,     scleral buckle or vitrectomy in index eye, inability to maintain appropriate head posture at     post-operative period and inability to visualize peripheral retinal due to media opacity.     Patients will be randomly allocated into two groups: PnR + cryotherapy/laser or vitrectomy +     cryotherapy/laser and the intervention will take place within 24 hours and 72 hours for     attached and detached macula status, respectively. Patients will undergo a complete     ophthalmological examination, including visual acuity and fundus assessment at baseline and     at 3, 6 and 12 months after surgery. Visual acuity will also be measured at 1, 7 and 30 days     after surgery. Global health related quality of life will be evaluated with the SF-36v2     questionnaire at baseline, 1 month, 1 and 2 years after intervention, while the VFG25     questionnaire will be applied at 3, 6, 12 and 24 months after surgery to measure vision     related quality of life.   "
31649|NCT02871492|"     Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess     pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative     lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or     Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject     within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of     herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4     days.      After self-initiation of treatment with trial medication subjects will be assessed daily by     the Investigator until complete healing for a maximum of 13 days.      Subjects will document application of trial medication and the status of their lesion in a     diary. There will also be blood sampling, ECG measurement and physical examination performed     at the investigational site.   "
33148|NCT02851888|"     The purpose of this research is to determine differences in outcomes in patients who do, or     do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip     arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement   "
31651|NCT02871466|"     stem cells therapy may be a choice therapy for advanced heart failure patients refractory to     medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous     history of myocardial infarction and coronary artery revascularization. These patients,     without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening     of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in     consecutive 30 selected patients the amelioration in failing heart NYHA class,     hospitalization rate, echocardiographic left ventricle functionality, and associated to     reduction of angina after a treatment with stem cells intra thoracic infusion.   "
31652|NCT02871453|"     The investigators design a randomized, control study to evaluate the therapeutic effect of     scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients     using the following outcomes: motor function, activity of daily living,quality of life.   "
31653|NCT02871440|"     Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is     being developed by Allergan. It is desirable to understand the effect that this new emulsion     has on tear film evaporation and tear lipid profile via interferometry, in patients with     evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate     the retention time of the lipid components of the new emulsion via tear collection and     analysis in EDE and non-EDE patients   "
31654|NCT02871427|"     This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the     treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder     (RBD) in subjects with Lewy body dementia (LBD).   "
31655|NCT02871414|"     The purpose of the project is to improve the sleep quality and sleep duration of post 9/11     veterans seeking college degrees. Preliminary research findings within CSU's New Start for     Student Veterans program indicate veterans with service-related injuries report difficulties     with sleep quality and duration. The REST program will recruit 24 college veterans and engage     them in a seven-week multi component sleep improvement program using evidence-based     educational and behavioral change supports that are considered best practice for improving     sleep quality. The investigators' scientific objectives in this application are to establish     the efficacy of a group-based sleep education and sleep-skills intervention to improve sleep     quality and duration, and to advance understanding of relationships between participants'     sleep-related knowledge and behaviors associated with improved sleep quality and duration in     veterans with service-related injuries in college. The investigators will initially engage 8     participants to establish treatment fidelity and participant satisfaction of the 7-week group     intervention. This will be followed by engaging 16 additional participants in the 7-week     group intervention, 8 will be randomly placed as wait-list controls and then receive the     intervention. The 7-week group intervention will take place within the CSU Occupational     Therapy Department, and all assessments will be completed using a web-based survey.   "
31656|NCT02871401|"     The investigators will conduct a single-center, prospective, randomized, placebo-controlled,     double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary     fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current     or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization will be to     pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will be enrolled     and randomized to treatment with pirfenidone plus valganciclovir (20 subjects) or pirfenidone     plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety and tolerability     will be determined by type, frequency and duration of adverse events (AEs) and serious     adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects will be     offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon     completion of treatment (12 weeks). Subjects will then be followed up at routine clinic     visits at 6, 9 and 12 months for data collection.   "
31657|NCT02871388|"     The objective of this protocol is to adapt and pilot test an existing lifestyle modification     intervention for weight loss for women with overweight or obesity who have had a recent false     positive mammography screen. The purpose of this pilot trial is to establish feasibility of     CONECT to promote weight loss through increased physical activity and diet change.   "
31658|NCT02871375|"     The purpose of this study is to evaluate DAILIES TOTAL1 ® Multifocal (DTl MF) contact lenses     in current multifocal contact lens wearers with symptoms of end of day discomfort compared to     their habitual multifocal contact lens correction.   "
31659|NCT02871362|"     The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-118 on the     systolic and diastolic blood pressure (BP) and to explore the effects on parameters of lipid     metabolism in subjects with elevated BP and low density lipoprotein cholesterol (LDL-C)     levels in a pilot study.   "
31660|NCT02871349|"     The purpose of this study is to find out how the brain of people with autism is affected by     Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA     approved for the treatment of heart conditions such as blood pressure      This research is being done because there are currently no drug treatment options for     language impairments and social difficulties often experienced by people with autism.   "
31662|NCT02871323|"     The main purpose of this investigational research study is to determine how safe and     tolerable the study drug, MEDI4736 (Durvalumab), is in patients with myelofibrosis (MF). The     study drug belongs to a group of drugs called immune checkpoint inhibitors, which have shown     promise in other forms of cancer, such as melanoma and lung cancer. One of the effects that     this drug has is to activate the patient's own natural immune system. The purpose of this     study is to examine the safety and tolerability of the study drug, to study how effective it     is at treating patients with myelofibrosis, and to explore how certain markers in the     patient's blood and/or bone marrow may be affected by the study drug.   "
31663|NCT02871310|"     The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive     effects in healthy subjects.   "
31664|NCT02871297|"     Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent     patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)     diagnosis of MDD   "
31665|NCT02871284|"     Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy     negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is     frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins     including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide,     lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and     potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or     preventive measures are lacking.      There is evidence that physical activity strategies are able to address existing CIPN     symptoms and potentially increase quality of life in affected patients. CIPN symptoms     involves restrictions of sensory and sometimes motor modalities, for example, deficits in     plantar perception and dysfunction of postural control and one study in type II diabetes     patients also suggested that structured exercise might have a preventive potential with     regard to peripheral neuropathy incidence.      Based on these findings, we aim to investigate the preventive potential of a sensorimotor     intervention vs. machine-based resistance training vs. usual care (wait-list control group)     in a randomized controlled three-arm intervention trial among cancer patients undergoing     chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to     include 82 patients per intervention arm resulting in a total patients number to be enrolled     of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and     electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via     questionnaires (EORTC QLQ-CIPN20 & FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the     effectiveness of the selected interventions will be objectively evaluated by spectral     analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are:     physical performance, sleep quality and chemotherapy compliance.   "
31666|NCT02871271|"     The purpose of this study is to evaluate the tolerability and benefit of IQP-AS-121 on     reducing fatigue and tiredness and to improve mental alertness.   "
31667|NCT02871258|"     To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of     atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open     label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who     qualify for enrollment in the study will receive therapy with The MetaNeb® System following     the labeled instructions for the device. Details of the treatment including duration and     frequency will be defined in treatment procedures.   "
31668|NCT02871245|"     Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle     section of the rectum will be as the research object. Cancer patients are diagnosed based on     pathology or cell biology. The trial is randomized, parallel and open. They are randomized     into 2 groups: both groups receive surgery. The experimental group receives conventional     treatment combine with electroacupuncture Zusanli point .etc finish operation and the     contrast receives the same conventional treatment with experimental group. Clinical     evaluation includes gastrointestinal tract recovery of function, pain relief, life quality     improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone,     peroxidatic reaction and the ratio of immune cells.   "
31669|NCT02871232|"     To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if     the REMS meets its surveillance goals, and if it does not, to modify it appropriately based     on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for     trends before and after the shared REMS is implemented to collectively assess for changes in     abuse, misuse, overdose, addiction, and death for different risk groups and settings.   "
31670|NCT02871219|"     The goal of this clinical research study is to learn if combining obinutuzumab and     lenalidomide can help to control previously untreated FL.   "
31671|NCT02871206|"     This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV)     to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in     Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine     whether the AV vaccine, can provide increased community-wide protection.   "
31672|NCT02871193|"     The procedures of thoracotomy are among the most painful operations. In addition to     post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative     discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient     and prevent postoperative complications such as pneumonia, atelectasis, or respiratory     failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard     technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such     as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory     depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an     alternative technique for TEA that may offer a comparable analgesic effect and a better side     -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as     single injection, they can provide analgesia for limited period. Various adjuvants have been     tried in the past in order to enhance the duration and quality of postoperative analgesia.     Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of     local anesthetic block. The mechanism of its action is blocking the nociceptive impulse     transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have     been shown to provide superior analgesia and greater patient satisfaction compared with     intermittent administration. System of wire-less PCA provides remote monitoring, information     management and PCA devices with high precision. The purpose of this research is to determine     whether dexamethasone might prolong the duration of analgesia and improve the short-time     outcomes when administered for TPVB along with local anesthetic agents in elective     thoracotomy.   "
31788|NCT02869659|"     This randomized controlled clinical trial will use methylomic and transcriptomic profiling to     examine the effects of a weight loss intervention on the cholesterol metabolism gene network     in monocytes and adipocytes and investigate the longitudinal relationship between these     modifications and glycemic improvements.   "
31673|NCT02871180|"     Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in     a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h     periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10     p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a     confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day.     Secondary endpoint was the blood glucose profile during this period.   "
31674|NCT02871167|"     The aim of the study is to perform a French multicenter prospective interventional study in     order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo     cryopreservation in young women with breast cancer. The oncologic and reproductive benefit /     risk ratio will be investigated in the oncology and reproductive area.   "
31675|NCT02871154|"     Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more     than 39 hours after hCG injection may be of benefit.      We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for     intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from     hCG to OPU.   "
31676|NCT02871141|"     The project aims to investigate markers of neural activity and connectivity, neurochemistry,     hypothalamic-pituitary-adrenal (HPA) axis activity, inflammation and neuronal plasticity     underlying treatment response and remission after ECT. These measures will be assessed in     depressive patients prior, during and after ECT and also after 6 months. Furthermore, we will     investigate a control group of depressive patients treated with antidepressants.   "
31677|NCT02871128|"     Iron deficiency problem has always been in Taiwan. This is a randomized, double-blind trial.     Subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day for     a total of 12 weeks, another group (n = 20) with the same dose of placebo, and the other     group (n = 20) is a commercial iron supplement. We assess whether Natureheme-iron can promote     iron absorption and antioxidant effects, and compare the effects with commercial iron     supplement. When this study is completed, it will increase the value of Natureheme-iron, and     can improve health of Taiwanese.   "
31678|NCT02871115|"     The purpose of this research study is to address the challenge of medication management for     older patients undergoing treatment for cancer. The sponsor of this protocol is the     Massachusetts General Hospital Cancer Center who is providing funding for this research     study.   "
31679|NCT02871102|"     Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which     the current standard treatment is supportive care and avoidance of complications with     lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a     means of lung protective ventilation, but the mechanism for its effectiveness is not yet     clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP).     Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible     means to minimize ventilator-induced lung injury. This protocol aims to identify the range of     safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and     the stress index, a tool to recognize potential lung hyperinflation during mechanical     ventilation.   "
31680|NCT02871089|"     The purpose of the study is to use a novel treatment approach, the artificial pancreas, after     diagnosis of type 1 diabetes (T1D) to improve glucose control with the anticipated     improvements of residual C-peptide secretion.      This is an open-label, multicentre, single-period, randomised, parallel group design study.     It is expected that a total of up to 190 subjects (aiming for 96 randomised subjects) will be     recruited within ten working days of diagnosis of type 1 diabetes through paediatric diabetes     centres in the UK. Half of the participants aged 10 to 17.9 years will be treated by     conventional insulin injections and the other half by the artificial pancreas (closed loop     insulin delivery system). Each treatment will last 24 months.      Subjects in the intervention group will receive additional training on components of the     artificial pancreas, i.e. insulin pump and continuous glucose monitoring (CGM), prior to     starting closed loop insulin delivery. Subjects in the control intervention group will     continue with standard therapy, i.e. multiple daily injection therapy. The study includes up     to 14 visits and 1 telephone/email contact for subjects completing the study. After run-in     and randomisation, visits will be conducted every 3 months in both arms. Beta-cell function     will be assessed by serial measurement of C-peptide in response to a standardised mixed meal     tolerance test (MMTT). MMTTs will be conducted at baseline, 6-,12- and 24 months post     diagnosis.      The primary outcome is the between group difference in the area under the stimulated     C-peptide curve (AUC) of the MMTT at 12 month post diagnosis. Secondary outcomes include     between group differences in stimulated C-peptide AUC over 24 months, differences in     glycaemic control as assessed by HbA1c, time spent in glucose target range, glucose     variability, hypo- and hyperglycaemia as recorded by periodically applied CGM, as well as     insulin requirements and change in bodyweight. Additionally, cognitive, emotional and     behavioural characteristics of participating subjects and parents will be assessed, and a     cost utility analysis on the benefits of closed loop insulin delivery will be performed.     Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes,     diabetic ketoacidosis (DKA) and number, nature and severity of other adverse events.   "
31681|NCT02871076|"     The objective of this study is to determine if acupuncture is an effective treatment option     for treating combat Veterans with PTSD.   "
31682|NCT02871063|"     The purpose of this piece of research is to assess the effect of altitude on the clinical     evolution of ARDS. For this purpose, patients who live and receive care at sea level are     compared with those who live and receive care at high altitudes. For reasons of convenience,     a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be sought     to assess whether adjusting the cut-points for the severity categories of ARDS improves the     ability to predict some adverse events, by comparison with unadjusted cut-points. The results     of this research will probably be disruptive, and will provide the first information yet     about the effect of altitude on ARDS; they will therefore be of great interest for the     international scientific community and for the direct care of patients. A high bibliometric     impact is to be expected.   "
31683|NCT02871050|"     The purpose of this study is to create a biobank, which collects, stores, and distributes     samples of human tissues, blood, and related health information to qualified scientists, in     order to help doctors and researchers better understand why Castleman Disease occurs and     develop ways to better treat and prevent it.   "
31684|NCT02871037|"     The current study is the first clinical trial proposed with PF-05221304. It is designed to     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of     single and repeated doses of PF-05221304 to healthy adult subjects. The study may also     evaluate effect of food on PK of PF-05221304.   "
31845|NCT02868918|"     The aim of this study is to compare the effect of new bioactive dentine substitute     (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and     radiographically using digital radiography in the terms of postoperative pain and     biocompatibility to the pulp.   "
31685|NCT02871024|"     Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized     fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized     trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe     sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The     data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited.     Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion     on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by     polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related     severe sepsis will attenuate sepsis associated microcirculation failure and result in early     reversal of shock and less extent of end-organ damage.   "
31686|NCT02871011|"     The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing     solution footbath and it's effect on the clinical signs and symptoms associated with Tinea     Pedis   "
31687|NCT02870998|"     This study aims to compare the impacts of two versions of a continuing education activity     targeted at COPD case managers on educational outcomes: 1) participation; 2) satisfaction; 3)     learning; 4) competence; 5) performance; 6) patient health outcomes.   "
31803|NCT02869464|"     The purpose of this study is to examine the percentage of patients who present with abdominal     aortic aneurysms (AAA) will also have intracranial aneurysms (IA) and conversely; to examine     the percentage of patients who present with intracranial aneurysms will also have abdominal     aortic aneurysms.   "
31688|NCT02870985|"     The clinical investigation is a non-inferiority, multicenter, blinding evaluation,     randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects     will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES,     in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment     of coronary artery disease.   "
31689|NCT02870972|"     This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in     preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the     study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks.     Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to     one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one     of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in     each treatment group, as well as a number of other clinical and pharmacologic outcomes, and     the safety and tolerability of each dose of BCX7353 compared to placebo.   "
31690|NCT02870946|"     Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support     device for cardiogenic shock (CS) patients. During ECMO support, renal replacement therapy     (RRT) facilitate more rapid metabolic or uremic control and more effective prevention and     management of fluid overload which happened in critical state. CS patients who are likely to     receive ECMO support will be enrolled and randomized with a 1:1 allocation to a simultaneous     RRT arm vs. standard care arm.        1. The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.        2. The patients in the standard care arm will not receive RRT when ECMO is commenced. Only          when a patient demonstrates AKI and fulfills any one of the criteria of the conventional          RRT indication during ECMO support or after ECMO weaning, conventional-indication RRT          would be delivered.      The primary outcome is all-cause 30-day mortality after ECMO is commenced   "
31691|NCT02870933|"     Heart Failure has several etiologies and one of them is coronary artery disease. Coronary     artery bypass grafting (CABG) is one of revascularizations method which has been used for     decades in coronary artery disease theraphy. However, data about coronary artery bypass     grafting shows that post-CABG patients still have low ejection fraction. For the last decade,     there have been a lot of studies about the using of stem cells to increase heart     contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone     marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells     is given during CABG by injection transepicardial and transseptal. The purpose of this study     is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem     cells can improve myocardial perfusion in patient with low ejection fraction following CABG     surgery.   "
31692|NCT02870920|"     The standard or usual treatment for this disease is treatment with drugs and other treatments     that may help to make a patient better or may improve their quality of life. This treatment     is known as best supportive care (BSC). Although patients with best supportive care can     feel better for some months, the cancer usually continues to grow.   "
31693|NCT02870907|"     Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to     histopathological risk factors of the International Retinoblastoma Staging Working Group.   "
31694|NCT02870894|"     Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute     respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for     estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW),     often are unreliable or require invasive measurements. The purpose of the this study is to     develop a novel approach to reliably assess extravascular lung water by electrical impedance     tomography(EIT).   "
31695|NCT02870868|"     Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S.     use breathing exercises for health purposes. The aim of this project is to examine if     different slow breathing has different physiological and psychological effects.   "
31705|NCT02870738|"     Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary     frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the     bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem,     tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS     symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in     treatment and often years of suffering. This clinical trial will test a bladder directed     therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT)     to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding     dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor     muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and     allow for early, more effective treatment.   "
31696|NCT02870855|"     Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive     technology, many studies have considered that the cause of two-thirds of implant failure is     the decreased endometrial receptivity. Human chorionic gonadotropin (hCG) is an early     pre-plant signal molecule secreted by the embryo, it can promote endometrial proliferation,     increase blood flow and promote embryonic adhesion and inhibit self-regulate apoptosis of     trophoblast cells. Previous studies showed that: intrauterine injection of HCG before embryo     transfer can improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But     some studies found that the intrauterine injection of HCG can not significantly improve the     success rate of blastocyst transfer, and the reason may be the intrauterine injection of HCG     time is too late to significantly increase the implantation rate. Would ahead of intrauterine     injection of HCG be more effective? Thus, the patients of repeated implantation frozen embryo     cycle according to the random principle accepted two kinds of transplants ways: ①intrauterine     injection of HCG before blastocyst transfer; ②blastocyst transfer. Try to understand whether     intrauterine injection of HCG can significantly improve the clinical pregnancy rate of     blastocyst transfer in repeated implantation failure patients.   "
31697|NCT02870842|"     Investigators hypothesized that maintaining low fraction of inspired oxygen would be     beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children     undergoing general anesthesia.   "
31698|NCT02870829|"     The proposed study will seek to evaluate the prevalence and the progression of vascular     calcification in a cohort of maintenance hemodialysis patients in Asian population. It will     also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of     vascular calcification in this group of patients.      This will be a single-center randomized, prospective and open-label interventional clinical     trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute     difference in coronary artery calcium (CAC) score at 18-month between control and     intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve     calcification, percentage of patients with regression of coronary artery calcification of at     least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any     cause and major adverse cardiovascular events (MACE) over the same period.   "
31699|NCT02870816|"     The purpose of this study is to determine whether amnion membrane grafts are more effective     than another tissue engineered skin substitute, when used to treat diabetic foot ulcers     (DFUs).   "
31700|NCT02870803|"     Around the world there is an increasing incidence of diabetes mellitus, with millions of     people affected. In this population, diabetic macular edema (DME) is the most common cause of     visual impairment. While the visual impairment caused by EMD is variable, its early treatment     can improve visual acuity and quality of life. The objective of this project is to use the     new OCT-angiography technology, which evaluates macular capillary network without the need of     intravenous injection of contrast, to assess macular microcirculatory network in its response     to intravitreal pharmacological treatment of EMD. The resulting qualitative evaluation can be     helpful in understanding the pathophysiology of visual loss associated with DME and in     determining prognosis.   "
31701|NCT02870790|"     A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual     elimination of HIV transmission in NSW by 2020. Critical to the new strategy's success is the     population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of     co-formulated tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC). This large-scale     study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will     comprise mostly gay and bisexual men (GBM) but will also include small numbers of     heterosexuals, injecting drug users, and transgender men and women. The drug will be used     according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new     intervention over a 12 month period, and following participants for two years on treatments,     a reduction of about 50% in new HIV diagnoses in NSW is expected.      The study aims to assess the incidence of HIV among PrEP study participants and measure the     population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over     a two-year period.      It will also evaluate the rate of PrEP uptake among high risk GBM in NSW, assess the     incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP     and measure the effect of the rapid roll-out of PrEP on the overall number of notifications     of gonorrhoea, chlamydia and infectious syphilis in NSW, describe patterns of PrEP use and     medication adherence, and monitor behavioural risk practices among PrEP users.      The main population group will be 3700 gay men at high risk of HIV infection. All procedures     of this study are guided by the NSW Guidelines on PrEP.      Protocol Co-Chairs Professor David Cooper, Professor Andrew Grulich. Protocol Coordinating     Investigator: Dr. Iryna Zablotska.   "
31702|NCT02870777|"     Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at     diagnosis are generally excluded from first-line allo-SCT. However, these patients may     eventually relapse in some of cases. The purpose of this study is to establish risk     stratification based on cytogenetics and minimal-residual-disease(MRD) analysis to determine     whether a MRD-directed therapy for low and intermediate AML patients has positive results in     terms of overall survival.   "
31703|NCT02870764|"     This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will     assess the effect of DanshenDuofensuanyan[Danshen (a kind of Chinese herbal drug) extract]     treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina     pectoris.   "
31704|NCT02870751|"     Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in     many countries. Vaccine candidates targeting ST are in development. A human challenge model     using an epidemiologically relevant enterotoxigenic E.coli (ETEC) strain expressing ST, but     not other diarrhea inducing toxins like heat labile toxin (LT), is necessary to perform an     early and efficient evaluation of an ST-toxoid based vaccine.      In this controlled human infection study the investigators will assess the safety of a     ST-only producing ETEC strain and the dose needed to achieve an attack rate of 70% in healthy     human volunteers.   "
31904|NCT02868151|"     The surrounding controversies both advocating and simultaneously opposing the use of vitamin     C, mostly extrapolating animal models to human models, it has not been used individually to     assess the severity of oral mucositis during chemoradiotherapy.      The present study is undertaken to evaluate the effect of vitamin C oral supplements in     assessing the severity of oral mucositis during chemoradiotherapy for oral cancer.   "
31706|NCT02870725|"     Having co-occurring depression and chronic headaches is challenging and can greatly impact     one's professional, personal, family, and social life. People living with chronic headaches     are often at a greater risk of having comorbid psychiatric disorders (depression, anxiety),     reduced quality of life, and impaired functioning because of under-diagnosis, misdiagnosis or     under-treatment of both chronic conditions.      This study is a pilot clinical trial that will compare the effectiveness of a brief     cognitive-behavior therapy (CBT) depression intervention to a care as usual (control) group.     The aim of the study is to determine how well the CBT intervention will reduce the frequency,     severity and level of disability of both the headaches and depression symptoms.   "
31707|NCT02870712|"     During childbirth, the recommendations have evolved to a restriction of episiotomy. This     reduction results in an increase of superficial vaginal and perineal tears. These lesions are     usually routinely sutured which often causes the onset of discomfort and pain in the     immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin     was not sutured perineal tears during the second degree. Others have compared different     techniques in the same indications (separated points running suture, biological adhesive)     without demonstrated impact. These studies were not interested in isolated perineal tears or     first degree or the application of a simple manual compression with or without a suture     according to the result of hemostasis.      Our objective is to evaluate the possibility of not suture the perineum of the first degree.     The use of suture only result of bleeding not yielding to manual compression.      Our approach is guided by the principles of primum non nocere and discerning about the     dogmatic systematization.   "
31744|NCT02870231|"     This trial is conducted in the United States of America. The aim of this trial is to     investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the     effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in     Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity   "
31708|NCT02870699|"     Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects     of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is     neutropenia. Skin and nail manifestations, frequency, the second category of adverse events     after haematological adverse events.      Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having     nail damage.      The purpose of this study is to confirm the effectiveness of the film-forming solution     Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and     treated by adjuvant docetaxel.   "
31709|NCT02870686|"     For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure.     However, the risk associated radiation exposure to patients and staff are not neglible.     Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile     duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is     highy accurate technique in detecting common bile duct stone and guiding for therapeutic     intervention. There has been a few data from literature showed that EUS guided CBD stone (     CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and     complications. This randomized trial is designed to address the question that EUS guided CBDS     removal is equivalent to ERCP in term of efficacy and safety.   "
31710|NCT02870673|"     In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral     neuropathy and usually happened to female, mid-age population, overweight persons, and those     who overused their hands for work or production. Some research claimed this might be     correlated to anatomical characteristics such as the longer anteroposterior diameter or     smaller cross section area of the wrist. Preliminary symptoms often start with sensory domain     (pain, tingling, paresthesia and especially night awakening due to symptoms mentioned above)     and then progress to motor domain (thenar muscle atrophy and clumsiness) if left untreated.      Depending on the severity, patient's willingness and convenience, there are many options for     CTS. For those whose symptoms are mild to moderate, conservative therapies are usually the     first choice, including physiotherapies, local injection and night splints. Local steroid is     proven to be effective to relieve the symptoms of CTS shortly up to 3 months. However, the     effects will decline gradually and repetitive injections is suggestive. The patients with     severe symptoms which comprise thenar muscle atrophy will be advised to receive decompression     surgery.the surgery can alleviate the illness with high success rate up to 70%.     Unfortunately, there are still patients who will relapse or undergo side effects, for     example, finger weakness.      In recent years, acupuncture researches focused on CTS intervention have been outgrowing and     promising. Whereas, there are still lack of evidence which stands for the therapeutic effects     comparing with local steroid injection. This limits the built-up of suspect mechanism of     acupuncture intervention for CTS.      This is a preliminary, randomized and single-blinded study which started since 2016 and last     for a year. The investigators utilize ultrasound to guide the depth of needle penetration     which prevents unnecessarily tissues injury such as artery or dry needle injury. This     procedure also guarantees the needles lie directly on the upper surface of the median nerve.     One group will receive electrical stimulation and another won't. The investigators use     electromyography, cross-section area of median nerve, visual analog scale, Boston Carpal     Tunnel Syndrome Questionnaire, six-item scale, The disabilities of the arm, shoulder and hand     score and Jamar grip dynamometer as outcome measurements. The results gathered from two     experimental groups will be compared with the data from the control group whose participants     only receiving local steroid injection once in the first week. The participants are all above     18 years old and complain of illness for a least 3 months without any surgery or local     injection for a least 1 year. The investigators set up strict exclusive criteria and sample     size estimation is 70.   "
31711|NCT02870660|"     Familial hypercholesterolemia (FH) is a most prevalent genetic disorder, defines as high     cholesterol level and premature death. The prevalence of FH has been reported in few     countries however unknown in Iran. Thus recognize the FH patients, determine the diagnostic     strategies and appropriate treatments are important.      Also acute coronary syndrome (ACS) is a group of conditions which arises from reduction of     blood flow in coronary arteries. Three specific conditions are included: ST elevation     myocardial infarction, non ST elevation myocardial infarction and unstable angina. Premature     ACS defined by occurrence of ACS<55 for men and ACS<60 for women. Studies demonstrated direct     connection between familial hypercholesterolemia and occurrence of premature ACS.     Investigators intent to detection of FH amongst patients with acute coronary syndrome.   "
31712|NCT02870647|"     Prospective, international, non-randomized, multicentre, clinical investigation (phase IV).     The aim of the study is to investigate the correlation between HF, severe SBD, and AF in     CRT-P patients at 6 months.   "
31713|NCT02870634|"     Multicenter, open-label , single and multiple dose-escalation and pharmacokinetic study   "
31714|NCT02870621|"     The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when     accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue     samples to test this hypothesis. Renal tumor could itself be responsible for inflammation and     fibrosis in its environment. This study aims to measure the influence of the tumor on his     kidney Environment and fat and define molecular markers not influenced by renal tumor. The     main objective is to compare the inflammation of the perirenal fat taken in two locations in     the same patient, in contact and 4 cm from the outer edge of the tumor, each patient as his     own control. The secondary objective is to compare the degree of interstitial fibrosis of the     renal cortex in the same sampling methods.   "
31715|NCT02870608|"     The objective of the study was to evaluated the feasibility and reproducibility of the     measurement of lung elasticity report / fetal liver according to gestational age in a group     of patients with a normal course of pregnancy and in a group of Patients at risk of preterm     delivery.   "
31716|NCT02870595|"     The investigators hypothesize that patients who receive 1% lidocaine injections for digit     blocks of the finger will experience less pain when the injection is accompanied by the use     of a micro-vibratory stimulator (MVS) compared with patients who receive injections without     the MVS.   "
31717|NCT02870582|"     The investigators do the clinical trial (patients with metastatic colorectal cancer treated     with donafenib/placebo after failure of standard therapy) to assess efficacy and safety of     donafenib in patients with metastatic colorectal cancer, progressing after all approved     standard therapies.   "
31718|NCT02870569|"     Donafenib for advanced 131I-refractory/resistant differentiated thyroid cancer(DTC).   "
31905|NCT02868138|"     The aim of this single-center observational study was to evaluate quality of life, clinical     effectiveness, and satisfaction in pediatric and young adult patients with sickle cell     disease receiving hydroxyurea.   "
31719|NCT02870556|"     Pharyngocutaneous fistula (PCF) is the most commonly reported postoperative complication in     total laryngectomy patients. PCF significantly increases morbidity, length of     hospitalization, and cost of care, in addition to delaying the beginning of adjuvant therapy.     The reported incidence of PCF ranges from 3% to 65%.The increased use of radiation in the     primary management of laryngeal carcinoma has resulted in an increase in the PCF formation     after salvage laryngectomy (STL).      Previously reported risk factors for PCF development include preoperative radiotherapy, tumor     stage, concomitant neck dissection, prior need for tracheotomy, hypoalbuminemia and anemia.      Among surgical options, the pectoralis major myofascial flap has been proposed to cover the     pharyngeal closure, to interpose non-irradiated tissue between the neopharynx and the skin     during STL. Nonetheless, the efficacy of this approach is not fully established.Epidural     anesthesia improves the blood supply due to its vasodilating effect. The aim of the study is     to evaluate the effect of perioperative cervical epidural analgesia on the occurrence of     pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis     major myocutaneous flap.   "
31720|NCT02870543|"     This study aims to evaluate, through a crossover, controlled, double-blind and randomized     clinical trial, the efficacy of Phytolacca decandra in association or not with Melissa     officinalis in the treatment of children with nocturnal bruxism. Children from 3 to 12 years     old with nocturnal bruxism will be randomly allocated into different groups of treatment     stage as follows: (1) placebo; (2) Phytolacca decandra; (3) Melissa officinalis; (4)     Phytolacca decandra associated with Melissa officinalis. All children will participate to     each clinical stage, with a period of 14 days of whashout. Children and the principal     investigator will be masked to treatment. The efficacy will be evaluated through parents     report about the absence of tooth clenching or grinding by children and electromiography     exams. The secondary outcomes that will be evaluated are: trait anxiety and quality of life     related to oral health.   "
31721|NCT02870530|"     The purpose of this study is to determine the efficacy of of gastric bypass without gastric     division as a treatment for morbid obesity   "
31804|NCT02869451|"     The purpose of this pilot project is to pilot-test a combined cannabis and smoking cessation     treatment. The intervention combines mobile technology with behavioral strategies,     counseling, and medications.   "
31722|NCT02870517|"     The purpose of this study is to assess the effect of music, played prior to a surgical     procedure, on stress levels during induction of anesthesia. Hypothesis: playing calming     music, pre-selected by the investigator and the patient, beginning just prior to induction     and terminating after induction will positively reduce the patient's heart rate, blood     pressure, and respiratory rate during this period. For this study, noise-cancelling     headphones with the ability to play music via an iPod will be utilized.   "
31723|NCT02870504|"     Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a     simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an     existing angle close or angle adhesion in order to reduce the risk of attack of the angle     closure glaucoma. However, there are very little research on the laser site, laser     wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine     the optimum laser site of LPI.   "
31724|NCT02870491|"     The purpose of this study is to assess how free distribution and preemptive home delivery of     oral rehydration salts (ORS) by community health workers affects ORS use. The investigators     will measure the impact of the combination of the two interventions (free distribution +     pre-emptive home delivery) as well as the impact of each intervention separately (free     distribution without home delivery and pre-emptive home delivery without free distribution).   "
31725|NCT02870478|"     The purpose of this study is to determine whether less frequent dosing of atropine drops may     be as effective as daily dosing for the treatment of progressive myopia.   "
31726|NCT02870465|"     The main objective of this non-interventional, observational study is to analyze the rate and     type of infection complications while performing closed reduction internal fixation (CRIF) of     hand fractures in the operating room versus an ambulatory setting. The investigators will do     so by prospectively collecting data on the type of fracture, handedness, co-morbidities,     duration of treatment, number and type of K-wires, duration of fixation and complication     rate. Patients presenting with hand fractures to the emergency room will be recruited.     Patients will be recruited in multiple centres across Canada and managed according to the     institutional standard. The complication type and rate will be recorded and analyzed to     determine a difference of performing the procedure in the operating room or clinical setting.   "
31727|NCT02870452|"     The purpose of this study is to evaluate the relative effectiveness of two psychological     interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and     managing pain, regulating emotional state and improving quality of life in Portuguese PWH.   "
31728|NCT02870439|"     Burn injury with full-thickness skin damage that encompass large body surface areas can     induce local and systemic perturbations that are costly in terms of human suffering as well     as in strains on the health care system. Characterization of new major molecular biomarkers     involved in this process creates significant diagnostic and therapeutic challenges.      Hypoxia-inducible factor-1 α (HIF-1 α) is a ubiquitously expressed heterodimeric     transcription factor comprising an α and a β subunit. It was shown that under normoxic     conditions, the HIF-1α subunit is ubiquitinated and degraded, whereas under hypoxic     conditions, HIF-1α accumulates, dimerizes with HIF-1β, and activates the transcription of a     spectrum of target genes encoding multiple angiogenic growth factors and cytokines of     potential importance in wound healing. Seven isoforms of HIF-1α issued from alternative     splicing have been identified.      The importance of HIF-1α in wound healing in animal models has been suggested by several     studies. Indeed, diminished HIF-1 levels and activity have been documented in conditions of     impaired wound healing. The literature review shows a marked reduction of HIF-1α levels in     mice in case of burn wound skin that in the case of excisional cutaneous wound. Other studies     have shown that the expression of HIF-1α was correlated with the extent and depth of the     burns.      This study aims to improve the knowledge on the pathophysiological factors involved in the     field of wound healing. The assumptions are based on results of studies done on mice, and     this work aims to document these findings in humans.      Objective      The main objective of the study is to compare the variations of expression of HIF-1α measured     in blood and skin tissue samples in three groups:        -  Subjects with major burn wounds involving more than 20% of the total body surface area;        -  Subjects with burn wounds smaller than 5% of total body surface area;        -  Subjects with a skin wound after a surgical procedure requiring a skin resection.      Secondary objectives are to compare the expression levels of HIF-1α locally at the burn site     to those observed in blood, to evaluate the expression of growth factors produced by HIF-1α     target genes (VEGF and EPO) or playing a central role in the healing process (TGF-β1), and to     assess the correlation between the expression of HIF-1α and the kinetics of wound healing of     the subject rated by evaluation of time of donor sites complete epithelialization.      Material and Methods      We propose to create three groups:        -  15 patients with extensive third degree burns involving more than 20% of the total body          surface area;        -  15 patients with less extensive third degree burns, involving less than 5% of body          surface area;        -  15 patients with post-surgical wounds with skin resection. Skin and tissue specimens          will be collected three times: day 0, 7 and 14 from burned patients (with more than 20%          of the total body surface area and less than 5% of body surface area). Samples of skin          tissue will be collected within the skin resection from patients with post-surgical          wounds at day 0, blood samples will be collected at day 0 and 14.   "
31729|NCT02870426|"     To obtain olfactory bulbs from brain stem dead patients who undergo organ donation.      Aims:        1. Optimisation of olfactory bulb collection and olfactory ensheathing cell culture and          storage.        2. Study of the effects of patient diagnosis, age, cause of death and co-morbidities on          cell survival and regenerative function.        3. In future studies, the olfactory ensheathing cells may be injected into patients with          spinal cord injuries.   "
31730|NCT02870413|"     The investigators will conduct a randomized controlled trial (RCT) to generate data on the     impact of direct-to-consumer telelactation (virtual breastfeeding support) services.     Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a     critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into     two study arms: 1) outpatient telelactation services via video calls on personal devices or     2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and     satisfaction with breastfeeding, will be captured via surveys and in-depth interviews and     compared across groups.   "
31731|NCT02870400|"     The primary objective of the study is to assess the safety and tolerability of single     ascending doses of REGN2477 in healthy women not of childbearing potential.   "
31732|NCT02870387|"     The investigators will conduct a pilot quality improvement trial to assess the impact of     offering inpatient consultation to further optimize coordination and improve care for     high-risk chronically ill children receiving comprehensive care in an enhanced medical home.   "
31733|NCT02870374|"     The project team developped and validated a French patient-based health-related quality of     life instrument in kidney transplant: the QoL Retrans.      The aim of the study is to determine the minimum significant change of the valdiated tool:     ReTransQol   "
31805|NCT02869438|"     The purpose of this study is to investigate the onset and maintenance of effect of     benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life     during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic     inflammation. A subset of patients will take part in body plethysmography substudy to further     investigate the effect on lung function.   "
31734|NCT02870361|"     Insulin resistance is a central pathophysiological component of type 2 diabetes and is     associated with a high risk of cardiovascular disease. The tissue in which it manifests are     mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is     independent of insulin, this organ has traditionally not been studied in this regard. In     animal experiments, however, knockout of the insulin receptor in the brain leads to obesity     and peripheral insulin resistance. This finding of insulin action in the brain could also be     confirmed in human studies.      The investiagtors intend to investigate whether central nervous insulin action affects     insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15     minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion.     Insulin sensitivity of the brain is measured by a an established protocol with functional     magnetic resonance imaging before and after nasal insulin administration.   "
31735|NCT02870348|"     This is a multi-center, open-label study to evaluate the long-term safety of weekly IV     infusions of 60 mg/kg Alpha-1 MP in adult subjects with AATD in Japan who have completed     Study GTI1401.   "
31736|NCT02870335|"     Introduction: Field hockey is a contact sport. Semiflexion asymmetric position, along with     other theories such as the weakness of the extensor muscles of the back or hamstring injury,     can be causes or aggravating that suelan hockey players suffer back pain. Objectives: To     observe the effectiveness of manual therapy techniques and post-isometric stretching (PNF)     after three treatment sessions. In turn, know which of the two treatments have a greater     benefit and longer. Methods: The population consists of grass hockey players and senior     category aged between 16-30 years. They were randomly divided into two treatment groups.     Group 1 corresponded to manual therapy techniques and group 2 to PNF stretching. The study     duration for each subject was 5 sessions that included 3 treatment and 3 assessments. Each     evaluation consisted of goniometry, balance test using the Sit and Reach, and Roland Morris     questionnaire.   "
31737|NCT02870322|"     This research will use randomized controlled trial (RCT) methodology to assess the     feasibility of a prescription for fruit/vegetable CSA shares or exercise by bikeshare on     obesity-related outcomes. Three cohorts of n=10 University of Wisconsin-Madison (UW) students     (total 30) will be randomized to three groups: (1) a 10-week fruit and vegetable community     supported agriculture (CSA) share prescription program with vegetable education and cooking     support from UW Slow Food; (2) a 10-week Madison B-cycle bikeshare membership prescription     program with exercise support or (3) a non-interventional wait-list control group. The     primary outcome will be change in Body Mass Index (BMI) (a measure of obesity using a     person's weight in kilograms divided by his or her height in meters squared). Secondary     outcomes will be fasting lipids, blood pressure, and glycated hemoglobin (HGA1c) levels. All     of these measures will be tested at baseline and just after the 10-week intervention   "
31738|NCT02870309|"     This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of     weekly intravenous infusions of 60 mg/kg of Alpha-1 MP for 8 weeks.   "
31739|NCT02870296|"     The primary study goal is to improve the quality of care transitions for patients with new     episodes of venous thromboembolism (VTE).      Primary Outcomes: To measure differences in the quality of care transition, as measured by     the Care Transition Measure (CTM)-15 in the investigators target population of patients with     incident VTE randomized to either a multicomponent, anticoagulation medical home intervention     or usual care.      Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage,     all-cause re-admissions, and mortality between the investigators intervention and comparison     groups at 30 and 90 days in the investigators target population.      Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and     time in the therapeutic range (TTR) for patients on warfarin in the investigators target     population.   "
31740|NCT02870283|"     To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD)     mixed episodes using medications available in the Brazilian Public Healthcare System (SUS),     and assessment of the quality of life of these patients.      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of     episodes of bipolar mixed episodes.   "
31741|NCT02870270|"     Radiation therapy (RT) leads to a markedly reduced salivary secretion rate, which makes it     difficult to eat and talk and it is a risk factor for oral disorders such as caries and     mucosal infections. A reduced salivary secretion rate is often a life long side-effect of the     treatment that seriously affect the quality of life. To reduce these side-effects the     patients get preventive and supportive oral treatment in connection with their cancer     treatment. However, regardless of radiation doses given, the severity of the problems vary     considerably. Therefore, a better understanding on when and why problems occur is important     for the identification of subjects at risk and to find better measures and treatments, suited     for their individual needs.      Dentate subjects were included referred before RT. Data were collected before and during     treatment as well as 6, 12 and 24 months after completed RT. Cancer diagnosis, treatment,     radiation doses, infections and medication were obtained from medical records.      Dietary habits were registered using a questionnaire focusing on intake of carbohydrate-rich     food-items and items containing sugar-substitutes. The subjects weight was registered before,     during and after RT.      A clinical examination was performed before and 6, 12 and 24 months after completed RT.     Panoramic x-rays were taken as well as bitewing radiographs. The number of teeth, caries     status, oral hygiene were registered. Mucositis was registered during RT.      Secretion of stimulated whole saliva was determined. Minor labial and buccal gland saliva     secretion rate was determined using the Periotron-method. Microbial samples were collected     from the tongue, buccal mucosa and supragingival plaque and microorganisms associated with     oral health and oral disorders analysed using cultivation technique.      The quality of life was registered using the questionnaires EORTC QLQ-C30 (European     Organization for Research and Treatment of Cancer Quality of Life Questionnaire). To address     additional symptoms associated specifically with cancer in the head and neck region and its     treatment, a complementary 35-item module, the EORTC QLQ-H&N35 was used.      The patients also completed the Hospital Anxiety and Depression Scales, HADS, which is used     to measure severity of anxiety and depressive symptoms and provides estimates of possible     mood disorders in patients with somatic comorbidity.   "
31742|NCT02870257|"     Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will     be recruited and randomized into two groups of treatment. The group a will receive a     strenghtening protocol with progressive overload during 20 sessions and group b will     receive the same protocol with minimal load, without change during the 20 sessions. The     primary outcomes measures will be pain, function, quality of life, global impression of     recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6     months (follow-up). The secundary outcomes will be disability, quality of life measure by     other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these     data, change will be measure from baseline at 10 weeks (after 20 sessions).   "
31743|NCT02870244|"     Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene     modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded     investigator initiated therapy for patients with advanced melanoma.   "
31745|NCT02870218|"     Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes     will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked     to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects'     menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine (standardized     nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group will include     32 heavy, long-time smokers (≥ 10 cigarettes/day for ≥ 10 years), and 32 light smokers with a     shorter smoking history (<10 cigarettes/day for <10 years), who are hypothesized to be more     sensitive to nicotine's reinforcing effects. Participants will also have free access to     nicotine-containing e-cigarettes (15 mg/ml) throughout the 12-week period. Abuse liability of     combustible cigarettes will be assessed by behavioral (cigarettes/day, time to first     cigarettes), self-report (rewarding effects, withdrawal symptoms) and biochemical indices     (expired air carbon monoxide, cotinine blood sampling).   "
31746|NCT02870205|"     Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo     NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis     (subjects 12 years of age and older)   "
31747|NCT02870192|"     Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative     adverse events is scant. A multicenter pool-analysis of prospectively collected database on     1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients     experienced complications, 41 discovered and managed intraoperatively, 22 postoperative     complications, and 9 required readmission. Despite accepted lower rate of morbidity, these     results come from four well equipped European centers by four surgeons practiced at least 200     LVMR.   "
31748|NCT02870179|"     The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical     Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during     non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse     Oximeter.      The study is observational in nature which quantifies device performance and accuracy in     compassion to a Reference Pulse Oximeter.   "
31749|NCT02870166|"     Given the structural essential, catalytic and co-catalytic played by zinc in many sections of     protein metabolism, carbohydrate and lipid (zinc is involved in the function of more than 300     metalloenzymes and metalloproteins), one can imagine the impact of a deficiency or even a     sub-chronic zinc deficiency on the health of the individual. Studies multiply that show that,     long-term, marginal zinc deficiency is a risk factor for the development of cancer or     neurodegenerative complex diseases (eg Alzheimer's disease). In addition, the short-term zinc     deficiencies foster the development of skin conditions and susceptibility to viral and     bacterial infections. The aim of this project is to identify, in the population of patients     with pseudo-acrodermatitis enteropathica (AE) tested in the investigators laboratory, rare     variants (mutations real epimutations or polymorphisms) located in solute carrier family 39     member 4 (SLC39A4) gene or in 55 other genes chosen for their role in zinc homeostasis.   "
31750|NCT02870153|"     The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and     Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal     cancer.   "
31751|NCT02870140|"     The primary objective of this study is to compare the performance of SUPRAFLEX to that of     XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The     patients will be followed through 3 years for major clinical events.   "
31769|NCT02869906|"     Functional assessment of non-culprit lesions during percutaneous coronary intervention (PCI)     in patients with acute coronary syndrome could improve risk stratification and shorten the     duration of hospital stay by decreasing the need for additional non-invasive stress testing     to detect residual myocardial ischemia. The investigators aimed to assess the reliability of     the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in     non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation     myocardial infarction (STEMI).   "
31752|NCT02870127|"     The existence of a family factor in the genesis of varicose veins is certain, but few studies     have addressed reliably instead of the genetic factor in clinical and molecular level. The     investigator initiated an original study to identify one or more genetic abnormalities     predisposing to varicose disease, based on a combined approach of genetic linkage and of     exome sequencing. The clinical research phase is an essential prerequisite to the     identification of genetic mutations; it is to identify large affected families and ensure an     extremely rigorous and accurate phenotyping of individuals over several generations. A first     clinical work has identified and / or phenotype 8 families with a genetically informative     family suggesting autosomal dominant inheritance. Linkage analysis suggested several     candidate chromosomal regions without allowing the identification of a gene. This project     aims to resume and expand the Family clinical investigations and apply the techniques of     genome analysis points, including exome sequencing on the most informative families to     identify the genes and mechanisms responsible of this disease and improve the prevention and     the treatment of varicose veins.   "
31753|NCT02870114|"     The purpose of this study is to implement a national survey to collect information regarding     Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial     factors.   "
31754|NCT02870101|"     The purpose of this study is to provide data and analyses to support 510(k) applications to     the FDA for multiple nucleic acid amplification tests (NAATs) diagnostic platforms.   "
31755|NCT02870088|"     The purpose of this project is to investigate the effect of breaking prolonged sitting on     acute adipose tissue and metabolic responses.   "
31756|NCT02870075|"     The purpose of this study is to investigate whether dietary conditions (fed versus fasted)     affects the acute responses to exercise.   "
31765|NCT02869958|"     It is recommended that patients with asthma owned a written action plan which must include     the names, doses and dosing of the treatment they should take when acute respiratory symptoms     occur.      Current written action plans must be short to be readily used (1 page) and, therefore, cannot     fit all acute situations. Moreover, they may not be available where and when required.      The investigators sought that a digital action plan, available through Smartphone or tablet     computer connected to the internet, could adequately provide suitable action plans according     to the severity of the described exacerbation, and would be more easily available when     useful.      The aim of the study is to study the effect of the use of a digital action plan for asthma     exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to     physicians or to emergency departments, hospitalizations) in children and in adults with     asthma. The investigators hypothesized that the use of the digital action plan could reduce     avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be     managed by the patient or his/her caregivers.   "
31757|NCT02870062|"     The search for preventive measure with daily bathing with chlorhexidine in the critical care     patient will result in a reduction in patient colonization with multidrug resistant     pathogens. Thus, preventing healthcare associated infections. The aim of this study was to     determine the impact of daily bathing with chlorhexidine in patient colonization, environment     and healthcare workers in the medical intensive care unit (MICU).      The study will be conducted at the University Hospital Dr. José Eleuterio González, a     450-bed teaching hospital in Monterrey, northeast Mexico.      This is a prospective, experimental, randomized, open-label, double blind study comparing     chlorhexidine versus placebo. Any patient 18 years or older admitted to the MICU or with less     than 48 hours of patient-days will be included. Patients who present burns with more than 20%     body surface, pregnant patients and patients with allergy history to chlorhexidine.      Samples will be obtained from the patient, patient environment and healthcare personnel.      Sampling of the environment (bed rail, mechanical ventilator, table adjacent to the bed,     etc.) and patient's anogenital and pharyngeal region will be collected with swabbing     technique using cotton swabs and cultured according to Public Health England.      Patient skin sampling will be obtained from anorectal region, pharynx, axillary and inguinal     fold collected with Williamson-Kligman technique. Colonies will then be further selected and     properly cultivated according to their characteristics. Antibiotic susceptibility, clonal     relationship, biofilm index and antibiotic susceptibility to chlorhexidine will be     determined.      Demographics and clinical data will be collected from admission, throughout hospitalization     and discharge.   "
31758|NCT02870049|"     The purpose of this study is to determine whether inreach and outreach strategies will be     superior to usual care, and combination of both will be superior to either strategy alone.   "
31759|NCT02870036|"     This study evaluates the safety, tolerability, preliminary efficacy and pharmacokinetics of     Simmitecan in patients with advanced solid tumors and Simmitecan, 5-fluorouracil and     Leucovorin Calcium,thalidomide in patients with advanced solid tumor or advanced/metastatic     colorectal cancer.   "
31760|NCT02870023|"     Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor     control, and compromised gait function. Reduced walking speed, balance, and fatigue are the     cardinal symptoms. In rehabilitation, strength and balance training are commonly used. There     is increasing scientific support of strength training for improving walking function. The     evidence for balance training remains flawed. It is known that neurological damage in MS     leads to increased cognitive processing in the planning of movements, which predisposes     fatigue. Since fatigue is also associated with impaired balance, it can be hypothesized that     motoric/balance training with an emphasis on cognitive load can affect gait and fatigue.      Purpose: The aim of the study is to determine whether there is a differentiated effect     between strength and balance training measured by motor function, strength, balance, and     fatigue.   "
31770|NCT02869893|"     The goal of this research study is to learn more about the pancreas. The investigators want     to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a     normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the     pancreas. The investigators also want to figure out how much fluid the pancreas releases in     response to secretin. Secretin is a chemical in the body that causes the pancreas to release     fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify     dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the     pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.   "
31761|NCT02870010|"     Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC)        -  classical chemoembolization consists in injecting an emulsion of an anticancer agent in          Lipiodol® via the hepatic artery        -  doxorubicin, an anthracycline, is the most frequently used drug in lipiodol          chemoembolization (LCE)        -  however, less than half of HCC respond favourably to classical lipiodol          chemoembolization (LCE) with doxorubicin/Lipiodol®      In this trial, we propose to introduce in clinical practice a strategy based on idarubicin to     achieve a more effective antitumor effect for the following reasons, recently pointed out by     our team:        -  idarubicin is an anthracycline that penetrates tumour cells more quickly and is more          cytotoxic than doxorubicin on hepatocellular carcinoma cell lines        -  idarubicin is injected in a solution of embolization microspheres of a diameter of          (300-500µm), which all the progressive and controlled release of the anticancer drug,          whereas the doxorubicin/Lipiodol® emulsion is unstable   "
31762|NCT02869997|"     The aim of this study is to evaluate the prognostic value of the suppression ratio monitored     by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient     admitted to our intensive care unit after a cardiac arrest are included. The results of the     suppression ratio will be collected in the 6 first hours of admission. We will evaluate the     link between suppression ratio and cerebral performance category score collected at three     months.   "
31763|NCT02869984|"     Poor functional outcomes has been reported inevitably, and up to 90% of the patients have     experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But,     currently there has been no specific treatment for ARS and symptom based empirical management     is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has     been revealed to be slowing the bowel movement and improving stool consistency and urgency.      We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS   "
31764|NCT02869971|"     The primary objective of this trial is to compare the 9-month effect on lower urinary tract     symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard     Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with     symptomatic BPH who failed after a first line medical treatment with alpha-blockers.      The secondary objectives of this study are to:        -  Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health          Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well          as the side effects of the 2 strategies;        -  Report the safety of PAE;        -  Evaluate patient's adherence to medical treatment;        -  Analyse the costs of each strategy and report the incremental efficiency (incremental          cost utility ratio) of prostatic artery embolization compared to medical treatment.   "
31776|NCT02869815|"     The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy     is controversial. Lower detection rate and higher false negative rate are the main problem.     The purpose of this study is to determine the detection rate and the false negative rate of     SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant     chemotherapy in patients with large or locally advanced breast cancer. This is a single arm     clinical trial.   "
31806|NCT02869425|"     This study is designed to assess the effects of a therapeutic dose of arbaclofen extended     release (ER) tablets compared with placebo on human sperm concentration, motility, and     morphology in male subjects with multiple sclerosis (MS).   "
31766|NCT02869945|"     Parkinson's disease onset is clinically defined as the appearance of motor symptoms including     akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at     least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the     level of dopaminergic denervation is not homogenous at the time of diagnosis.      Some patients have a higher level of dopaminergic loss at disease onset indicating the     existence of compensation mechanisms. The aim of this study is to decipher how the metabolism     of dopamine is involved in this compensation with a focus on the polymorphism of the COMT     gene. This gene is expressed according to two variant: (i) COMT H that encodes a form of the     enzyme with a high level of activity and (ii) COMT L that encode a form of the enzyme with a     low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH     associated with an increased degradation of dopamine, (ii) COMT LL associated with a     decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT     LL).      The hypothesis is that this polymorphism of the COMT gene may participate to compensation     mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms     onset than patients with COMT LL genotype.      To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17     patients for each genotype). Given the distribution of COMT polymorphism in the population, a     maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.      Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms     scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's     disease behavioral assessment scale (ECMP). All the patients will have a monophotonic     emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic     denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be     optional and will allow direct measurements of dopamine metabolites.      The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane     scans according to COMT genotype, age, gender and severity of motor symptoms on the MDS-UPDRS     part 3.      If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in     order to delay dopaminergic drugs initiation for PD patients.   "
31767|NCT02869932|"     The strategy of neonatal screening for Cystic Fibrosis in France relies on Immuno Reactive     Trypsinogen (IRT) at day 3/DNA analysis with a CF Elucigen 30 mutations kit/ IRT safety-net     at day 21. This strategy has significantly improved the performance of CF neonatal screening     (NNS) in terms of positive predictive value and sensitivity but revealed new difficulties. Up     to 85-90% of CF patients detected through the NNS program has a classical CF form with a     positive sweat test and 2, 1 or no CF causing mutations but the remainder has either 2 CFTR     mutations with at least one non-CF causing mutation and a sweat test <60mmol/L or 1, 0 CFTR     mutation and an intermediate sweat test value ≥ 30 et < 60mmol/L raising a diagnosis and     prognosis dilemma. Meanwhile the vast majority of these cohorts will remain asymptomatic over     time, some will develop symptoms prompting clinicians to maintain a rigorous surveillance for     the entire atypical cohort, whose modalities vary a lot among centers and countries.      This prospective multicenter study with a standardized assessment of a matched cohort with     atypical CF versus classical CF from 6 years of age (60-65 cases in each cohort) is aimed     at evaluating pulmonary and nutritional status to, better define the best monitoring     follow-up, therapeutic management and familial genetic counseling.   "
31768|NCT02869919|"     This study aims to investigate whether there is a difference in Vitamin D levels between     critically ill adult patients with and without acute kidney injury.   "
31771|NCT02869880|"     Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster     randomized controlled trial to determine whether, in parents (of children with Crohn's     Disease) or patients > 18 years old being approached for trial participation, a pre-consent     discussion enhanced with decision aids is more effective than the standard pre-consent     discussion in transferring knowledge to parents/patients related to trial participation.   "
31772|NCT02869867|"     Nursing study, prospective, randomized, two-center open-label.      Patients will be randomized into two groups during their first laying Qutenza®:        -  Patients receiving the laying of Qutenza® without refrigerated cushion        -  Patients receiving the laying of Qutenza® associated with a refrigerated cushion      The objective of the study is to evaluate the effectiveness of the application of cold to the     reduction of pain (burning) after one hour of patch installation high concentration capsaicin     (Qutenza®) in patients localized neuropathic pain.   "
31773|NCT02869854|"     In a pilot study 90 physically inactive patients will be randomized to three different     intervention groups; mindfulness training, mindfulness training and Physical Activity     Referral scheme (PARs) or only PARs Follow-up will be done at baseline, three and six months     with questionnaires, accelerometers and analysis of traditional risk factors to evaluate     whether mindfulness may increase physical activity and decrease physical inactivity.   "
31774|NCT02869841|"     Midline laparotomy is commonly used in emergency and elective cancer surgery and patients     need effective and safe pain treatment after this type of surgery. Nowadays modern     anticoagulant therapy may prevent use of central regional blocks in pain management.     Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied     using different administration techniques. The primary aim is the efficacy of the rectus     sheath analgesia measured with pain ratings and the amount rescue opioid used.      Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to     analgesia method used.   "
31775|NCT02869828|"     Core temperature monitoring is mandatory during major surgery. The accurate techniques     currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive     cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core     temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal     temperature (30 patients) and to artery catheter (20 patients) in adult patients during     surgery.   "
31793|NCT02869594|"     Database of Institut Paoli-Calmettes patients diagnosed with prostate cancer   "
31794|NCT02869581|"     Database of Institut Paoli Calmettes diagnosed with Pancreatic neoplasms   "
31777|NCT02869802|"     Researchers are looking for better ways of understanding and treating pancreatic cancer. The     purpose of this study is to see how useful it is to look for changes and characteristics in     your genes (molecules that contain instructions for the development and functioning of the     cells) and the genes within the tumour. These characteristics may be useful in choosing     treatments for patients in the future. Changes (mutations) in genes have been shown to be an     important characteristic in cancers. Looking at differences in genes in patients with     advanced pancreatic ductal adenocarcinomas and comparing this information with response to     their initial chemotherapy treatment may help to learn which treatments may be better for     certain patients after initial treatment.   "
31778|NCT02869789|"     A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients     with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or     non-small cell lung cancer that has come back.   "
31779|NCT02869776|"     The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in     high prevalence settings, such as detoxification centers with a large proportion of young     injection drug users. The latest venipuncture testing will be compared to rapid finger stick     testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a     short-term drug detoxification center will be determined.   "
31780|NCT02869763|"     The aim of the clinical trial is to study the intra-individual variation of steroid profile     parameters after experimental administration of different doses of ethanol in Caucasian     women.   "
31781|NCT02869750|"     To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin),     in obese and non-obese patients with polycystic ovary syndrome (PCOS).   "
31782|NCT02869737|"     Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its     detection mainly relies upon classic biological test like the prothrombin time and the     international normaliezd ratio (INR). These tests are not available at the bedside. Point of     care (POC) device for INR measurement are now available like the Coaguchek, Roche, France.     The aim of the present study is to test the correlation between the POC INR and the     laboratory INR.   "
31783|NCT02869724|"     This study will evaluate the efficacy of an advice with a weekly divided drug delivery,     compared to an usual monthly delivery in the prevention of voluntary drug intoxications     repeated.   "
31784|NCT02869711|"     The present study focuses on the quality of care and how the health executives can bring it     to a central place in their management. A training-action has been set-up at the Health     Executive training institute (University Hospital Grenoble) to improve care quality. Reports     prepared by students (tutored projects) related to operational diagnosis and action plans     about care quality improvement are given to health executives. The objective is to evaluate     how the health executive will use the tutored project to improve care quality and set-up     actions.The hypothesis is that the health executive will use the tutored project to improve     project management.   "
31785|NCT02869698|"     This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of     cortical electrical stimulation to identify major anatomical and functional networks in     epileptic patients candidates for surgery and explored by stereoencephalography, to minimize     risk of post-surgical cognitive deficits.   "
31786|NCT02869685|"     The detection of tissue PD-L1 immunohistochemistry in NSCLC has an important role in guiding     for the treatment of immune detection point.Radiation therapy can enhance the effect of     immunotherapy,but radiation dose and timing are waiting to be solved. At the same time,tissue     detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor     tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive     means of detection. The project is planned to explore the consistency analysis of PD-L1     expression level detected in tissues and pExo before and after radiotherapy.We have designed     five kinds of radiation-division with bioequivalent doses, and detected the expression levels     of PD-L1 in pExo after 24h, 48h of each stage of radiotherapy.PD-L1 mRNA levels in pExo     detected at different time points,by using variance analysis of repeated measures design     information.Probing the best timing and manner of radiotherapy division which can make PD-L1     express more,guiding clinical practice of radiotherapy combining with immunotherapy.   "
31789|NCT02869646|"     Current treatments for Veterans with PTSD include medications and therapy where the patient     talks about traumatic events in order to desensitize to them. While these treatments work for     many, a large minority of Veterans do not want medications or exposure therapy. The     investigators developed an acupuncture (ACU) treatment for PTSD in order to broaden treatment     options. The investigators' first study showed that it helped most people. However, the     investigators need better scientific evidence that it works by comparing ACU to a placebo,     such as sham acupuncture (fewer needles in non-important sites) and determining if ACU     alters abnormal physiology in PTSD. In this study 90 Veterans will be randomly assigned (like     a coin flip) to receive either ACU or sham. The investigators expect to find that the ACU     treated patients have more improvement in PTSD and in physiology (less startle reaction -     assessed non-invasively using skin sensors) than the patients in the sham group. This study     will provide information to support the use of acupuncture for PTSD at the VA, which will     expand treatment options.   "
31790|NCT02869633|"     This phase II trial studies how well ibrutinib works in treating patients after a donor stem     cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
31791|NCT02869620|"     Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer   "
31792|NCT02869607|"     Database of Institut Paoli-Calmettes patients diagnosed with breast cancer   "
31807|NCT02869412|"     This randomized pilot clinical trial studies how well a computer-based behavior change guide     works in increasing physical activity in patients with prostate cancer who have received     androgen deprivation therapy. A computer-based behavior change guide website may increase     physical activity level for prostate cancer survivors and help doctors understand what     outcomes related to becoming physically active are most important to patients with prostate     cancer.   "
31808|NCT02869399|"     This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed     to be in complete remission at month 3 after curative treatment are considered for this     trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary     intervention in addition to standard recommendations and a control arm (arm B) including only     standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations     for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia     and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor     recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric     Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of     side effects and quality of life, as assessed by the EORTC QLQ-H&N35 questionnaire.     Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial     is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries.   "
31809|NCT02869386|"     Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces     alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest     cost-effectiveness. However, scientific proof of improved functional outcome compared to     usual care is still lacking. The objective of this trial is to show improved functional     outcomes after deployment of the Stroke Emergency Mobile (STEMO) compared to regular care.   "
31810|NCT02869373|"     The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization     exercise program on pain, trunk muscle endurance and postural stability in women with benign     joint hypermobility syndrome   "
31811|NCT02869360|"     Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled     clinicians to measure disease activity but there are inherent limitations.     Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not     specific.      This pilot study is an opportunity to determine the relationship between quantitative     advanced MRI measures and OCT with PET measurements of microglial activation and myelin     health.   "
31812|NCT02869347|"     Iodinated contrast media have been causally linked to acute kidney injury known as     contrast-induced nephropathy (CIN), which is the consequence of CM-induced local renal     ischemia and direct toxic effects. Conestat alfa (recombinant human C1 esterase inhibitor)     has been shown to decrease renal ischemic damage in experimental models of renal ischemia.      The Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy     in High-risk Subjects (PROTECT) Study is a randomized, placebo-controlled, double-blind     single-center trial that will assess the effect of prophylactic administration of Conestat     alfa on the degree of acute kidney injury subjects undergoing elective coronary angiography.     Patient with an estimated glomerular filtration rate <=50 ml/min/1.73 m2 and at least one     additional risk factor for CIN will be enrolled and randomly assigned to 1) Conestat alfa at     50 U/kg given as intravenous injection immediately before and 4 hours after coronary     angiography or 2) placebo (sodium chloride). All patients will receive standard intravenous     hydration with isotonic saline. Surrogate markers of kidney injury will be assessed over a 48     hours time period. Patients will be followed for cardiovascular and renal events over 12     weeks.      The primary outcome measure is peak change in urinary Neutrophil gelatinase-associated     lipocalin within 48 hours after elective coronary angiography.   "
31813|NCT02869334|"     The purpose of this study is to determine whether transcranial direct current stimulation     (tDCS), when combined with different forms of computer based training, improves the ability     to discriminate small differences between sounds in people diagnosed with schizophrenia or     schizoaffective disorder.   "
31846|NCT02868905|"     The purpose of this study is to compare average methylation of epigenetic markers on genomic     DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:        -  Of obese young adults and healthy young adults        -  Of obese young adults and individuals affected by Alzheimer's disease (AD) having been          obese at young adult age (<50 years old) or individuals affected by Alzheimer's disease          (AD) having never been obese.      The secondary purpose is to determine if there is an association between the frequency of     these epigenetic markers and elements associated to the metabolic syndrome (lipidic and     glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass,     body mass index) in young adults.   "
31847|NCT02868892|"     Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the     cervix will receive Pemetrexed.   "
31814|NCT02869321|"     Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be     performed with a radiological approach. This procedure is usually not performed under general     anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric     insufflation and incision of the abdominal wall. Standard analgesic treatments are usually     not well-fitted due to onset of action or route of administration. An alternative solution     could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use     allowing repetition if needed, during the procedure.      The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT®     to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®),     in radiologic percutaneous gastrostomy tube placement:        -  during the procedure        -  following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30          min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).      Secondary purposes are to compare easiness of 2 treatments and their adverse effects.   "
31815|NCT02869308|"     The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF)     obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are     equivalent.      Secondary purposes are:        -  To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences          defined in primary purpose        -  To evaluate the influence of the indication for the examination with a distinct analysis          of a group having the examination for a known or suspected cardiomyopathy (LVEF often          abnormally low) and a group having the examination for a chemotherapy supervision with          heart initially considered healthy (LVEF often normal).   "
31816|NCT02869295|"     This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study     of NKTR-214 in adult patients with locally advanced or metastatic solid tumors.   "
31817|NCT02869282|"     Multicentric, observational, prospective, non-interventional study with occasional biological     sample collection (serum bank, urine bank and tumor bank)   "
31818|NCT02869269|"     Previous studies have shown that colorectal cancer patients' prognosis and overall survival     was related with immune cell expression in patients' tissue. However, the circulating immune     cell activity changes in patients' blood has few studies. The purpose of this study is to     analyze the variation of circulating immune cell activity in colorectal patients' blood which     is classed as clinical staging.   "
31821|NCT02869230|"     Here were present a controlled clinical trial comparing wire-guided lesion localization     (WGLL)and radioguided occult lesion localization (ROLL) in patients treated for nonpalpable     breast lesions at the Instituto Nacional de Cancerología (National Cancer Institute)in     Bogotá,Colombia.   "
31822|NCT02869217|"     The target populations for this phase I study with TBI-1301 are patients with advanced solid     tumors. Patients' tumors will be required to express NY-ESO-1, which include but is not     limited to ovarian cancer, synovial sarcoma, esophageal cancer and malignant melanoma.     Patients must be positive for HLA-A*02:01 or HLA-A*02:06 and the patient's tumor tissue must     be positive for NY-ESO-1 antigen expression. The study will take the subject's T cells, which     are a natural type of immune cell in the blood, and send them to a laboratory to be modified.     The changed T cells used in this study will be the subject's own T cells that have been     genetically changed with the aim of attacking and destroying cancer cells.      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back     to the subject through an intravenous infusion. The purpose of this study is to test the     safety of genetically changed T cells and find out what effects, if any, they have in     subjects with advanced solid tumors.      The purpose of this study is to evaluate the safety profile of TBI-1301, to determine the     recommended phase 2 (RP2D) dose of TBI-1301 when administered following cyclophosphamide     pre-treatment and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.   "
31823|NCT02869204|"     The purpose of this project is to investigate whether a combination of a local injection of     platelet rich plasma (PRP) combined with a daily supplement of vitamin C, zinc, L-arginine,     as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote     tissue healing in patients undergoing open upper-abdominal surgery.      Primary endpoint is cases of wound infection and secondary endpoints are time of tissue     regeneration (days), judged by traditional clinical observation and experimentally assessed     by ultrasound.      The experiment is performed as a parallel two-armed, randomized, controlled trial.      A total of 40 subjects will be included in the trial i order to ensure the power of the     study, despite a drop off of up to 25%.   "
31824|NCT02869191|"     The purpose of this study is to assess the blood cultures' profitability in intensive care     unit and create a validated prediction rule for extractioning in critical patients.   "
31825|NCT02869178|"     Introduction : Patients with heart failure (HF ) with systolic dysfunction of moderate to     severe exhibit significant reduction in the ability to exercise compared to those with mild     dysfunction , and have worse prognosis. However, some clinical markers of severity and     diagnosis widely used in this population such as ejection fraction (EF) , are not always able     to translate the actual degree of cardiac damage as well as their relationship with the     cardiorespiratory fitness of these individuals and prognosis .      Objective: To evaluate the ability of the global longitudinal strain ( GLS ) in predicting     exercise tolerance in heart failure patients with moderate and significant systolic     dysfunction.   "
31826|NCT02869165|"     A randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal     alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of     menopause.   "
31848|NCT02868879|"     The different subtypes of Schizophrenia might have a disordered connectivity as their final     common pathways.      The investigators will use multimodal structural MRI to assess anatomical connectivity on the     one side and its functional consequence on functional connectivity on the other side to     assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with     control subjects.      The coherence between structural and functional anomalies will be especially studied.   "
31917|NCT02867982|"     This is a two-year prospective randomized clinical study to to evaluate whether the gingival     thickness and insertion depth of dental implants have any influence on marginal bone levels     changes around platform switched implants.   "
31827|NCT02869152|"     The purpose of this study is to develop a technique that allows physicians to identify the     first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there     is no technique used to find these lymph nodes in the rectum during surgery and therefore     many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers,     imaging and a gamma probe will be used in this study during a standard minimally invasive     transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able     to locate these lymph nodes they will be removed during surgery. If the technique is     successfully developed as a result of this research, it could help patients in the future     with early stage rectal cancer by allowing doctors to see if their cancer has spread to the     lymph nodes of the rectum without having to undergo a total rectal resection. These patients     would then be able to undergo a TES combined with a lymph node dissection to gain more     knowledge about the stage of their disease. This knowledge would then be used to determine if     and what further treatment is necessary for the patient's rectal cancer.   "
31828|NCT02869139|"     Package of mentholated measures for the relief of thirst in the anesthesia recovery room:     Randomized clinical trial   "
31829|NCT02869126|"     The purpose is to demonstrate the concordance of diagnostic information obtained with:        1. a conventional examination with 2 distinct recordings on D.SPECT camera after          99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours          later,           and        2. a double isotope examination with a supplementary recording after injection of a little          activity of thallium-201 at rest after the first recording and before the second          injection of 99mTc-sestamibi for conventional recording at rest,      in patients showing abnormalities of myocardial perfusion in stress myocardial     tomoscintigraphy.   "
31830|NCT02869113|"     The objective of this study was to compare the human eye stinging potential of experimental     formulas and an industry standard shampoo mixture. The study was conducted under the     supervision of a Board Certified Ophthalmologist.   "
31838|NCT02869009|"     The risk of early recurrence or progression of acute ischemic stroke is very high, even in     patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment     reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or     minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased     hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the     dual antiplatelet treatment could reduce the risk of early recurrence or progression in     patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators     hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in     this group of patients.   "
31839|NCT02868996|"     This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in     healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous     dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.   "
31931|NCT02867800|"     To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-Ig) when     added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin     inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine,     thiotepa, melphalan, and alemtuzumab for conditioning.   "
31831|NCT02869100|"     The purpose is to compare detection of axial inflammatory lesions in patients affected by     spondyloarthritis (SpA) with sodium fluoride positron emission tomography (PET) and magnetic     resonance imaging (MRI), the reference technique.      It would be interesting to show the superiority of sodium fluoride PET on MRI for diagnosis     of inflammatory lesions. It could be used for diagnostic care but also therapeutic care of     patients with early forms of spondyloarthritis.      Secondary purposes are:        -  To evaluate performances of sodium fluoride PET in detection of SpA peripheral damage          (except spine and sacroiliac joints)        -  To evaluate bone inflammation (axial and peripheral) with sodium fluoride PET and          compare these data to clinic-biologic parameters used in clinical practice (BASDAI,          BASFI, BASMI, sedimentation rate, C-reactive protein (CRP)) and to structural evaluation          (sacroiliac New York, mSASSS and BASRI scoring methods)        -  To study correlation of axial and peripheral bone inflammation (spine and sacroiliac          joints) evaluated with sodium fluoride PET with biologic markers of inflammation and          bone remodeling (MMP-3; DKK-1, IL-6, IL-17, TNF-α).      Known biologic markers of inflammation in SpA are correlated to activity obtained with MRI.     It is interesting to compare to activity obtained with PET. Moreover, it has been recently     showed the disassociation of inflammation and structural progression (anti-TNF treatments do     not prevent structural progression) that is associated to markers of bone remodeling whose     activity is influenced by an activation/inhibition system of biologic markers of     inflammation.   "
31832|NCT02869087|"     The aim of this study is to prospectively collect information to evaluate the safety and     performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system     for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the     superficial femoral artery (SFA).   "
31833|NCT02869074|"     The present Project is a third phase of the previous PCM-EVW-ES Project (Batlle et al. Thromb     & Haemost 2015) with the aim of its extension, further analysis with an innovation     development in the field of von Willebrand disease (VWD) based in the newer recently     available methodologies. The aim of this project is to help the physician in a more uniform     characterization and therapy of VWD in clinical practice, at an international level. A     reduction of the expenses in the diagnosis process by using the new methodologies is pursued.   "
31834|NCT02869061|"     Autologous adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by     enzymatic digestion from a portion of the fat harvested from the patient's front abdominal     wall. Transurethral bladder neck resection followed by the injection of ADRCs suspension will     be performed. This is a single arm study with no control. All patients receive cell therapy.   "
31887|NCT02868372|"     The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc     of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both     groups will be followed up during hospital stay and outpatient clinic visits a week and a     month after cesarean delivery for surgical site complications which will be evaluated by the     researcher.   "
31835|NCT02869048|"     Amyotrophic Lateral Sclerosis (ALS) is an aggressive, deadly disease. ALS leads to     destruction of the neural pathways which control the conscious movements of the muscles. This     destruction leads to muscular dystrophy with increasing difficulties in moving, breathing,     swallowing, and speaking. In the last phase of an ALS patient's life it is necessary with     respiratory therapy in order to breathe. In average an ALS patient lives 3 years from the     time he or she gets the diagnose.      The cause of the disease is still unknown and there is currently no treatment which can stop     the progression of the disease. Former clinical studies have indicated that the innate immune     system and in particular the complement system plays a significant role in the progression of     ALS. The complement system, which is activated in cascades, is part of the innate system but     participates in the innate as well as the acquired immune system. Former clinical trials have     been characterized by limited knowledge about both the complement system as well as to how it     is measured.      Today it is possible to measure directly on the different components of the complement system     and to understand its contribution to the overall immune response. It is also possible today     to detect defects of the complement system. All these progressions are the foundation for     this project which is carried out in close cooperation with one of the world's leading     researchers in the complement system, professor Peter Garred from Rigshospitalet.      The aim is to make a national research project about ALS in order to investigate the role of     the innate immune system, and especially the complement system, in patients with ALS.      In the long term the hope is, that this will lead the way to a targeted and effective medical     treatment to the people affected by this grave disease.   "
31836|NCT02869035|"     Major Depressive Disorder (MDD) is one of the most severe and frequently occurring brain     disorders worldwide. It has been linked to serotonergic dysfunction, sexual dysfunction,     vulnerability to stress and neuro-inflammation. However, at the same time the etiological     understanding is limited. Most antidepressants act on the serotonin (5- HT) system, yet     between 30-50 % of patients with MDD does not respond successfully to 5-HT acting drugs.     Recent experimental models from our group suggest that cerebral 5-HT levels in vivo can be     indexed through molecular brain imaging of the 5-HT 4 receptor (5-HT4R) with a novel Positron     Emission Tomography (PET) ligand (11C-SB207145). Also, our human studies have confirmed that     cerebral synaptic 5-HT is inversely related to 5-HT4R binding and this technique thus can be     used to investigate the role of 5-HT tone in the brain in MDD with differential responses to     standard antidepressant treatment. By using multimodal neuroimaging technology, we aim to     determine the status of the 5-HT system prior to and after either successful or failed     neuropharmacological intervention in a non-randomized longitudinal open clinical trial. 100     untreated patients with moderate to severe MDD will be included. Data collection from various     neurobiological domains (i.e, 5-HT4R PET imaging, Magnetic Resonance Imaging (MRI),     functional MRI (fMRI), electroencephalogram (EEG), psychometrics, neuropsychological tests,     and peripheral biomarkers) will be conducted before, during and after 12 weeks of     antidepressant treatment. The objective is to identify predictors of pharmacological     antidepressant treatment response in depressed individuals before and after 8 weeks of     antidepressant treatment.   "
31837|NCT02869022|"     The objective of this investigation is to demonstrate non-inferiority in outcome of     Custodiol-N against Custodiol in heart transplantation.   "
31925|NCT02867878|"     The investigators will randomize patients admitted to hospital with Takotsubo diagnosis to     systematic high-dose adenosine infusion for 3 minutes (in addition to standard of care) vs.     standard of care. The primary aim of the study is to demonstrate that adenosine infusion is     associated with a larger and more rapid recovery of left ventricle function.   "
31840|NCT02868983|"     Behavioral problems are part of many of the chronic diseases that cause the majority of     illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse,     failure to take treatment, sleep problems, anxiety, depression, and stress are major issues,     especially when chronic medical problems such as heart disease, lung disease, diabetes, or     kidney disease are also present. These behavioral problems can often be helped, but the     current health care system doesn't do a good job of getting the right care to these patients.      Behavioral health includes mental health care, substance abuse care, health behavior change,     and attention to family and other psychological and social factors. Many people with     behavioral health needs present to primary care and may be referred to mental health or     substance abuse specialists, but this method is often unacceptable to patients. Two newer     ways have been proposed for helping these patients. In co-location, a behavioral health     clinician (such as a Psychologist or Social Worker) is located in or near the primary     practice to increase the chance that the patient will make it to treatment. In Integrated     Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely     with the medical provider as a full member of the primary treatment team.      The research question is: Does increased integration of evidence-supported behavioral health     and primary care services, compared to simple co-location of providers, improve outcomes? The     key decisions affected by the research are those made at the practice level: whether and how     best to use behavioral health services. For patients, whether to seek out or accept offered     behavioral health services will be influenced by the manner they are made available.      The investigators plan to do a study of 40 practices which will each start off using     co-location. Over time, each one will convert to IBH using a practice improvement method that     has helped in other settings. The investigators will measure the health status of patients in     each practice before and after they start using IBH. The investigators will compare the     change in those outcomes to health status changes of patients in practices who have not yet     started using IBH.      The investigators plan to study adults who each have both medical and behavioral problems,     and get their care in Family Medicine clinics, General Internal Medicine practices, and     Community Health Centers.   "
31841|NCT02868970|"     This project proposes to implement and compare new community pharmacy-based strategies for     improving vaccine coverage.   "
31842|NCT02868957|"     The objectives of this study were to compare the precision of two digital intraoral scanners     from a series of repeat scan images, and to investigate the effect of the learning curve on     changes in trueness when scanning the full arch of the oral cavity in actual patients.   "
31843|NCT02868944|"     The addition of morphine to a local anesthetic when performing an epidural analgesia during     labor analgesia has improved the efficiency and the action duration of analgesia. One     limitation of this technique is the time of installation of the analgesic effect (about 30     minutes) when using the only epidural. Therefore, the technique of sequential combined spinal     epidural was introduced. This is to shorten the installation time by direct injection into     the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been     shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the     effect of the local anesthetic.   "
31844|NCT02868931|"     This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly     developed treatment and education programme for diabetic patients with an insulin pump     therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the     difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome     variables are: diabetes-related distress, depressive symptoms, health-related quality of     life, diabetes self-efficacy, self-care behavior, hypoglycemia awareness, and attitudes     towards insulin pump therapy.   "
31849|NCT02868866|"     The USC PRC's applied research project will study the dissemination and implementation of an     evidence-based program shown previously to significantly increase physical activity and fruit     and vegetable intake in churches in South Carolina (Faith, Activity, and Nutrition; FAN).     Guided by two theoretical frameworks, the specific aims of the applied research project are     to: 1) examine the adoption and reach of FAN in churches and organizational factors     associated with adoption; 2) characterize implementation fidelity and multilevel factors     associated with implementation; 3) describe organizational maintenance of FAN and factors     associated with maintenance; and 4) study the effectiveness of FAN. In Phase 1, churches in a     rural county with a high proportion of African American residents will be randomized to     receive training in FAN from a community health advisor (n=40) or to be part of a delayed     intervention control group (n=20). In Phase 2, a quasi-experimental study wil be done with a     large religious denomination in SC (churches are not randomized).   "
31850|NCT02868853|"     The purpose of the study is to test the effectiveness of two different methods of mobile     dietary self-monitoring for weight loss. Both of these interventions will provide weight loss     information through twice weekly audio podcasts. In addition to the podcasts, participants     will be asked to track their diet using an assigned mobile applications (for their     smartphone), which will be randomly assigned.   "
31851|NCT02868840|"     Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by     continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the     integration and balance of mind and body using the fundamental principles of slow, smooth,     and continuous movement control, and the transfer of body weight while maintaining an upright     and relaxed posture. The present randomized clinical trial project aims to apply the     suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to     evaluate the effects on physical (balance), psychological, and cognitive function.   "
31852|NCT02868827|"     The purpose of the research study is to determine whether a single high dose of vitamin D is     helpful in reducing critical illness related complications in intensive care patients who are     having sever vitamin D deficiency.      Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A     number of scientific studies have documented a strong correlation between low levels of vit.D     and increased rate of adverse outcomes including infection, acute kidney injury and mortality     in ICU patients. A recent randomized controlled trial (RCT) has demonstrated 50% reduction in     hospital mortality in severe vit.D deficient patients following a single high dose of     cholecalciferol (Vitamin D3). However the role of Vit.D supplementation to boost up host     immune system and eventually reduction of mortality has yet to be determined by large     randomized controlled trails in humans. Hence we aim to run a randomized controlled trial     (RCT) in order to study the role of Vitamin D in critically ill patients.   "
31853|NCT02868814|"     The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained     release tablets versus placebo for fibromyalgia   "
31854|NCT02868801|"     The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained     release tablet versus placebo for postherpetic neuralgia.   "
31855|NCT02868788|"     This study will help elucidate the mechanism underlying the cardioprotective and     anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and     oxidative stress markers, based on a contemporary understanding of this process. In addition,     there have been very few studies that explored the immediate change in oxidative stress and     incretin secretion after fiber intake. In this study, the investigators will be able assess     the short term metabolic impact of dietary fiber at great details. The result will contribute     to dietary recommendation or designing of fiber supplementation for prevention/treatment of     diabetes, obesity and cardiovascular disease.   "
31856|NCT02868775|"     This is a prospective pilot study, with a recruitment goal of 60 patients. Patients who are     female, above the age of 18, and with a diagnosis of IC/BPS based on clinical criteria and     O'Leary Sant ICPI and ICSI scores undergoing cystoscopy, hydrodistention and bladder biopsy     will be included. The bladder biopsies will be evaluated for TLR4 expression, and sent for     histological assessment of mast cell count. Additionally, data will be collected at baseline,     day of surgery, day 7, day 14 and day 28. Data will include validated questionnaires, lower     urinary tract symptoms, and recorded pain medication use.   "
31857|NCT02868762|"     This study investigates in patients whose primary complaint is either neck pain and/or a     voice disorder , if there are any correlations between subjective neck and voice symptoms     according to Neck Disability Index (NDI) and Voice Handicap Index (VHI). NDI and VHI     questionnaire results for voice disordered patients will be retrieved from the data base of     the Department of Phoniatrics and Speech Pathology, University Hospital Zurich. Neck pain     patient questionnaire data will be retrieved from an ongoing study. The agreement between     subjective neck handicap (NDI) and voice handicap (VHI) will be statistically analysed.   "
31858|NCT02868749|"     This study is a single-blind intra-individual comparative study to evaluate the short and     medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA),     designed for deep injection, that have been used for several years on a worldwide scale.   "
31859|NCT02868736|"     -  To demonstrate the tests' performance when compared to the detection of PJI using the          Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing          PJI.1 This criteria-based definition of PJI places emphasis on culture techniques that          identify pathogens, but also provides for minor criteria that can be used to diagnose          PJI;        -  To calculate the tests' clinical sensitivity, clinical specificity, positive predictive          value (PPV), and negative predictive value (NPV).   "
31888|NCT02868359|"     The purpose of this study is to evaluate the effect of pregabalin on patient reported     outcomes compared with conventional analgesic care in chronic cervical pain patients with     accompanying upper limb radiating pain (neuropathic component) treated in primary care     settings under routine clinical practice.   "
31918|NCT02867969|"     This is a piloting study using continuous motor training provided via whole body-controlled     video games (exergames) to establish proof-of-concept evidence that such training leads to     motor and neural changes in pre-manifest subjects with spinocerebellar ataxias (SCA).   "
31919|NCT02867956|"     The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients     with platinum resistant or refractory ovarian cancer when combined with etoposide.   "
31860|NCT02868723|"     This will be a prospective randomized 2 year study of patients admitted to the Hamad General     Hospital (HGH) and the Stroke Prevention Clinic with a diagnosis of ischemic stroke (IS) and     Transit ischemic attacks (TIAs). After signing of the informed consent forms and initial     evaluation and investigations, all patients enrolled in the two arms ( study arm and control     arm) of the study will be followed for one year (monthly visits for the first three months     followed by visits three months until completion of study: total of 6 follow up visits) and     the pre-specified investigations repeated at the one year follow up. In one arm (the control     group), the patients will be offered best risk factor management strategies as currently     being practiced by stroke specialists at HGH in Qatar. And in the second ( the subject group)     arm, with assistance of a nurse-practitioner and pharmacist, the investigators will make     aggressive attempts to meet to target defined risk factors and have the evaluations and     investigations completed as in the initial year cohort. All patients will have risk factor     stratification according the Framingham Risk Score (FRS) and the change in score measured     over time.The primary objective will be to determine if an approach that utilizes a     comprehensive strategy results in a significantly outcome. A clinically 'meaningful'     difference in the blood pressure (BP) and lipid control of 10% between the aggressively     managed versus patients treated with the standard of care will require minimum of 200     patients in each group (alpha error set at 0.05 and beta error at 0.20, power 80%) to be     recruited over 1 year and followed for one year (total study duration 2 years).      All patients will have screening magnetic resonance imaging (MRI) (including gradient echo     (GRE) sequence), carotid 3D Doppler measurement of plaque volume, and PAD assessments,     C-reactive protein (CRP) and evaluation for protein urea at baseline. These studies will be     repeated in 1 year at the time of exit from the study. The co-primary objective would be to     monitor progression (or regression) of plaque build-up on 3D Doppler imaging of the carotid     arteries between the two cohorts. The investigators hypothesize that aggressive management of     vascular risk factors to recommended target levels will lead to better vascular health.     Compared to current practice, comprehensive and coordinated approach at preventive measures     will lead to more patients with better control of blood pressure and lipid levels. Improved     risk factor management will result in slowing of atherosclerosis and its downstream effects     which will be measurable on sophisticated blood and imaging testing. Clinically this will     translate into fewer hospital re-admissions.   "
31861|NCT02868710|"     The purpose of this study is to: 1) determine the cohort specific technical error to use in     the categorization of response rate; 2) determine if an individualized intensity prescription     is superior to a standard approach in regards to VO2max and cardiometabolic risk factor     responsiveness; 3) Investigate the time course changes throughout 12 weeks of CRF training     between an individualized and standardized exercise prescription; and 4) determine if     non-responders can become responders if the exercise intensity prescription is modified.      It is hypothesized that:        1. The individualized method will elicit a greater responsiveness for all measurements when          compared to the standardized method.        2. There will be a greater amount of non-responders in the standardized group (based on          changes in VO2max).        3. When participants in the standardized group are considered non-responders and change          their exercise prescription to the individualized group, they will become a responder          (based on changes in VO2max)   "
39707|NCT02765880|"     The main purpose of the study is to examine to which extent abnormalities in the dynamics of     neural activities observed in patients with psychosis is related to difficulties at ordering     simple visual stimuli and/or personal events.   "
31862|NCT02868697|"     Goal of the study:      A- To find out the best protocol for catheter lock solution to decrease the prevalence of     catheter thrombosis        1. - The time to first episode of catheter thrombosis lead to catheter change.        2. - Number of acute episode of thrombosis that interrupt dialysis        3. - Median Survival life of the catheter in both groups after adjusting it to the outcome.      B- Specific Objective: To evaluate the cost effectiveness by measure        1. Amount of r-TPA used in each group to treatment acute catheter thrombosis        2. Number of catheter exchange in both group        3. Hospitalization days related to catheter malfunctioning or CRI in each group        4. Type and days of antibiotics        5. Cost of the treatment in each group           c- Secondary Objective:           To correlate the result of two catheters lock solution protocols with the published data          using r-TPA instead of heparin once week as compared with heparin 3 times per week as a          locking solution.   "
31863|NCT02868684|"     This longitudinal cohort study aims to detect the topographical nature of the white matter     microstructure and resting state functional connectivity patterns across the whole brain in     the evolution of pathology as a function of time following mild TBI. All consecutively     patients with the non-contrast head CT because of acute head trauma from the local emergency     department (ED) formed the initial population of this study. Age, sex, education-level     matched healthy controls will also be enrolled. The initial scan will performed within 7 days     post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a     broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1     month, 3 month, 6-12 months.   "
31864|NCT02868671|"     The overall goal of this study is to examine if acupuncture intervention can reduce the onset     of post-traumatic stress disorder (PTSD), and affective and cognitive complaints among mild     traumatic brain injury (TBI). This study also hypothesized that compared to those in the sham     acupuncture and waiting list control groups, patients in the real acupuncture group will have     fewer symptoms of depressive symptoms, sleep problems and post-concussion symptoms.   "
31865|NCT02868658|"     Although clinical presentation of influenza is often symptomatic, asymptomatic cases also     occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is     very important because of the risk of cross-transmission to hospitalized patients. The     principal objective of the study is to estimate the incidence of symptomatic and asymptomatic     influenza among healthcare workers in short-stay wards. The results of this study will lead     to a better understanding of the burden of asymptomatic influenza among healthcare workers     and might be used as an argument to increase influenza vaccine coverage among healthcare     workers.   "
31866|NCT02868645|"     Fibrous dysplasia is a rare bone disease which can cause pain and fractures. It has been     shown that periostin is over expressed in fibrous component in patients bones ; but periostin     has never been measured out in serum of patients, although it is easy to assess. This study     aims to show whether serum periostin is elevated in serum of patients with fibrous dysplasia,     and if it is more elevated in patients with severe forms of the disease.   "
31867|NCT02868632|"     This is an open-label, three-cohort, phase Ib study to determine the safety, recommended     phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in     combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of     MEDI4736 and tremelimumab for patients with unresectable locally advanced adenocarcinoma of     pancreas.   "
31953|NCT02867514|"     The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial     Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent     subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which     is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also     evaluated 1 month post-treatment.   "
31868|NCT02868619|"     Obesity, defined as BMI> 30kg / m2, is a major public health problem, with devastating     medical and psychological consequences. 30% of obese suffer from BED type of eating     disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of     cases. Many arguments are in favor of the involvement of the reward circuitry, with the     central role of NAc in the pathophysiology of BED and obesity. The recent application and     effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest     that DBS may be of interest in treating obesity and BED with potential target for the NAc.     This project propose to study fMRI activation of the reward system in response to food     stimuli to better direct the DBS targets. This is a pilot study to define indication criteria     based on fMRI to obese BED patients are potential candidates for treatment with DBS.   "
31869|NCT02868606|"     Many hospitals have begun giving insulin to nearly all patients with diabetes while they are     in the hospital even if a patient does not use insulin at home. Controlling blood sugar with     insulin when a patient is hospitalized is believed to reduce the risk of complications and     death, but research has not demonstrated these benefits except in patients who are critically     ill. The purpose of this study, therefore, is to evaluate whether such insulin therapy     actually does reduce in-hospital complications, deaths, need for intensive care, or length of     stay in the hospital.   "
31870|NCT02868593|"     The primary purpose of this study is to assess the contribution of a non-invasive sampling     (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.   "
31871|NCT02868580|"     This is a phase 2a open label, multicentre design study to investigate the safety of Triumeq     in patients with ALS at 24 weeks post treatment. In this phase 2a study the investigators aim     to determine whether a combination of anti-retroviral therapy, Triumeq (dolutegravir 50mg,     abacavir 600mg, lamivudine 300mg) is tolerated and safe in patients with ALS. As secondary     outcomes, ALSFRS-R, ALSQOL, physical examination, neurophysical parameters and respiratory     and muscle function will be evaluated. Blood and urine samples will be stored for possible     future analysis for viral activity. Subjects will be screened for the study after signing an     approved Informed consent document.   "
31872|NCT02868567|"     This study will comprise an 18-week open label safety and tolerability trial. In this study,     a total of 35 subjects with primary lateral sclerosis PLS or upper motor neuron predominate     ALS will be enrolled. At the initial screening evaluation, a baseline T25FW will be obtained.     This baseline test will be repeated at weeks 2, 4, 6, 10, 14 18. The validity of this measure     was shown in MS studies when compared to the MSWS-12 (12 item walking scale) and CGI     (clinical global impression) scales (35-37). A consistent responder will be defined as     improvement in 3 of 4 Timed 25Foot Wwalk while on medication, compared with the baseline     results while off medication.   "
32038|NCT02866409|"     This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to     local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control     post craniotomy pain.A third group where patients were administered bupivacaine only     infiltration has also been created.   "
31873|NCT02868554|"     Purpose:      The objective of this study is to investigate the effects of accelerated Invisalign and     vibration therapy on rate of orthodontic tooth movement, activation of inflammation     biomarkers as well as pain levels experienced by orthodontic patients during the initial 12     weeks of alignment.      Participants:      Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency     Program will be recruited for this study. Patients older than 18 years old will be otherwise     healthy subjects previously diagnosed with malocclusion.      Procedures (methods):      Each patient will be randomly allocated into either a control group or one of two     intervention groups. Patients within the control group will receive standard Invisalign     therapy without vibration. Patients within the intervention groups will receive accelerated     Invisalign therapy with or without vibration. Patients receiving vibration therapy will     utilize an AcceleDent Aura device which provides a light vibration at .25 Newtons (N) and 30     Hertz (Hz) frequency for twenty minutes daily. Three dimensional images of each subject's     dentition will be recorded five times at 0 days, 4 days, 2 weeks, 6 weeks, and 12 weeks     progress visits.   "
31874|NCT02868541|"     The objective of this project is to study the prevalence of viruses and bacteria responsible     for transmissible acute respiratory infections in the respiratory tract of pilgrims returning     from the trip. The patients included, will be the consultant pilgrims to the traveler health     center, and before leaving for Hajj. Based on the results obtained in previous studies, it is     estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3     years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to     departure for the hajj. In return, patients will be reconvened systematic consultation to     record medical events potentially encountered during the trip, and it will again be performed     the same nasal swabs and throat. It will then be performed on these samples' return from hajj     molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism:     influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4),     enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus,     Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus     influenzae, Neisseria meningitidis and Coxiella burnetii. Samples return of hajj positive     should be cultured for the isolation of the strain. For patients positive return, it will be     done further research of these 35 viruses and bacteria on samples start of hajj, the same     method described above. In addition to this systematic consultation, and if symptoms return,     the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic     management.      This study will shed light on the acquisition of microorganisms respiratory tropism during     the stay and on the potential risks associated with the circulation of these pathogens after     the trip.   "
31889|NCT02868346|"     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the     diagnosis in less than two hours of sexually transmitted infections caused by known     pathogens, close to the reception of Emergency service. In this instance 30% of patients have     no etiological diagnosis after the POC sexually infection transmitted tests .      Most sexually transmitted infections can be diagnosed from an anal swab which is not     routinely performed. In this study, we suggest to test the hypothesis that anal swab in     addition to the routine genital swab would increase by at least 5% the diagnosis capacity of     sexually transmitted infections after the POC tests.   "
31875|NCT02868528|"     With the development of society, more and more aged pregnant women because of various     reasons, their abnormality rate of egg chromosome was higher than that of young women, then     the abnormality rate of embryo chromosome is higher too, so the pregnancy rate in aged women     is lower, abortion rate is higher. In order to improve the pregnancy rate in aged women, cut     down their abortion rate 、fetal birth with abnormal chromosome, and the risk of pregnancy     termination after the prenatal diagnosis, reduce their pain of body and mind, the     investigators will carry out this study. This is a prospective randomized controlled study of     preimplantation genetic screening with Next generation sequencing technology. The embryos     with more developmental potential and normal chromosomes should be selected. There is no     related studies in Chinese. Most international research are limited to fluorescence in situ     hybridization (FISH) technique, not on the embryo chromosome comprehensive screening. So     there is no evidence of the effects of PGS on advanced age women.      This study is to compare the outcomes between the advanced age women with two methods     respectively. After blastocyst culture, blastocysts will be transferred in the control group.     In the Preimplantation Genetic Screening (PGS) group, blastocyst embryo trophoblast biopsy     will be performed and chromosome screening with Next generation sequencing（NGS） technology,     at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome     will be thawed and transferred. The investigators expect that, in PGS group live birth rate     、cancellation rate and pregnancy rate are higher than in control group; abortion rate is     lower than that of the control group.   "
31876|NCT02868515|"     The objective of this study is to examine the effects of 2 servings of hot cereal per day     over 2 weeks on digestive health in children that typically eat low fiber diets.   "
31877|NCT02868502|"     The purpose of this study is to investigate the effect of trabeculectomy, glaucoma drainage     devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP elevation with     postural change from the sitting to supine positions in eyes with open-angle glaucoma.      Patients will be assigned to the different study groups according to their past ocular     history. Interventions are similar to all study group and no medical therapy alteration will     be made.   "
31878|NCT02868489|"     The hypothesis is to determine the effect of bacillus coagulans and galactomannans     (LactoWise®) administration on microbiota of obese patients undergoing sleeve gastrectomy by     observing standard protocol measurements in patients following sleeve gastrectomy: blood     markers and weight, in addition incorporating the Gastrointestinal Quality of Life Index     (GIQLI)   "
31879|NCT02868476|"     Clinical and subclinical thyroid disease is usually used to describe patients with mild     symptoms correlated to hyperthyroid or hypothyroid state. Therapeutic decision for clinical     and subclinical thyroid dysfunction should be considered individually. But long term outcome     for treatment of such functional and structural thyroid diseases had not been recorded     delicately in Taiwan. Further investigations should be observed in the future.The purpose of     this study is aiming for early prevention and detection the potential risk factors for     thyroid diseases in Taiwan.   "
31880|NCT02868463|"     The purpose of this study is to characterize bladder urinary oxygen tension (BUOT) in women     whose urinary microbiomes contains at least one anaerobic bacterial species versus women     whose urinary microbiomes do not contain anaerobes.   "
31934|NCT02867761|"     The study hypothesis is that symptomatic current and former smokers with spirometric values     within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC < 80% predicted     [to guard against restrictive lung disease]) will still derive symptomatic benefit from     long-acting bronchodilator therapy even though they are excluded from current GOLD guideline     recommendations.   "
31881|NCT02868450|"     In 2012, a previous work showed that T. whipplei is a common bacterium detected in various     situations. A large part of the population is therefore exposed to a T. whipplei but there is     that some people probably with immunological and genetic factors predisposing which develop a     disease. The association teams with experience in HLA-typing will allow us to better identify     patients with a risk of chronic complication.      The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in     patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple     disease and/ or, endocarditis and/or encephalitis).   "
31882|NCT02868437|"     This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked     hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following     curettage for retained product after second trimester abortion. One group of participants     will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid     gel while the other group will underwent curettage alone (control group).   "
31883|NCT02868424|"     Early Phase I Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment     Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD)     Patients   "
31884|NCT02868411|"     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the     diagnosis in less than two hours of traveller's fever caused by known pathogens, close to the     reception of Emergency service. In this instance 30% of patients have no etiological     diagnosis after the POC traveller's fever tests .      The objective of this study is to implement a new diagnosis strategy relying on the     hypothesis that a rectal swab would improve the etiological diagnosis of traveller's fever of     at least 10%.   "
31885|NCT02868398|"     This study monitors the efficacy and safety of Golimumab in maintaining deep remission and     quality of life in Ulcerative Colitis patients in deep prolonged remission with Infliximab.     Patients will be followed up for one year and they will be assessed with biochemical tests     (C-Reactive Protein , Full Blood Count , Faecal Calprotectin),endoscopic evaluation (MAYO     Score) and finally histologically.   "
31886|NCT02868385|"     An open label, randomized controlled trial of single vs. multiple treatments of praziquantel     in intestinal African schistosomiasis in Côte d'Ivoire      This study aims to determine the efficacy of repeated (up to four times) praziquantel     treatment against S. mansoni infection in school-age children from Côte d'Ivoire using the     traditional Kato-Katz thick smear technique, but also with more accurate and non-invasive     antigen- and DNA-detection methods.   "
31954|NCT02867501|"     The aim of the study is to assess if venous distension in patients with aneurysmatic     arteriopathy is higher compared to patients with peripheral arterial occlusive disease (PAOD)     and in controls.   "
31890|NCT02868333|"     Background: Most children with primary immune deficiency (PID) now reach adulthood. However,     few studies have evaluated their health status and health related quality of life (HRQoL).      Objective: To investigate long-term morbidity, the French Reference Center for PIDs initiated     a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency Long-term     Cohort). The data collected will be used to assess the physical health condition of patients     who reached adulthood and the impact on their quality of life.      Methods: Patients are asked to complete health status questionnaires. A severity score     (grade1 [mild] to grade 4 [life-threatening]) is assigned to each health condition. The     HRQoL of patients is compared to age- and sex-matched French normal values using the SF36     HRQoL questionnaire.      Capsule summary. This will be the first study of adult survivors of childhood PID describing     how the burden of health conditions affect their quality of life.   "
31891|NCT02868320|"     This study was conducted at the teaching hospital of Misr University for Science &     Technology. It aimed to examine the use of SMS technology in educating and monitoring     diabetic patients in Egypt, and assess the impact of educational text messages on their     glycemic control and self-management behaviors. Participants were randomized into an     intervention and a control group. Intervention patients received an instruction booklet as     well as daily educational and weekly reminder messages to better control their diabetes.     Control patients received the same instruction booklet but no SMS messages. Both group     patients took an HbA1c test at the beginning and end of the study period and were asked to     measure their blood glucose once a week and record their readings into a monitoring table     over 12 weeks. The primary outcome was the change in HbA1c levels, which was expected to be     greater among intervention patients at the end of the study. Secondary outcomes included     blood glucose levels, treatment and medication adherence, diabetes self-efficacy, rate of     hospital/ER visits, frequency of blood glucose measurement, among others.   "
31932|NCT02867787|"     Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the     most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of     botulinum toxin are mainly based on its ability to block the neuromuscular transmission by     preventing the release of acetylcholine, creating paralysis muscle relative and reversible.      It has been used in the treatment of cervical dystonia, migraine headaches, and an     antinociceptive effect. The analgesic effect occurred even prior to the release muscular.     Several randomized studies have been published about it. The investigators assume that     intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy     rotator cuff.   "
31892|NCT02868307|"     Quality of life (QoL) measurements have become an important way to evaluate the treatments     and care provided to patients with schizophrenia. Understanding determinants of QoL in     schizophrenia is of importance for developing effective interventions that would improve     patient functional and subjective well-being. A challenge in the interpretation of QoL     measures, especially in longitudinal studies, is that QoL is self-reported by the patient and     might be influenced by psychological phenomena such as adaptation to illness. An important     mediator of this adaptation process is a response shift (RS), which involves changing     internal standards, values and the conceptualization of QoL. RS can be divided into three     phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a     change in the importance attributed to component domains constituting QoL) and 3)     recalibration (i.e., a change in a patient's internal standards of measurements). Patients     may change their frame of reference, rendering scores from different measurement occasions     incomparable. An RS is a potential explanation when the QoL of an individual who has     experienced a serious health event or chronic condition is similar to the QoL of a healthy     individual. With an RS, the concept of QoL changes over time and cannot be compared     longitudinally because of changes in internal standards, values, and/or concepts. True change     may be over- or underestimated when a RS is present, leading to biased estimates of the     magnitude of change.The objective is to examine whether a response shift, a change in the     internal standards of a patient, occurs in patients suffering from schizophrenia and in their     caregivers.      This is a monocentric and propective design study, with inclusion of patients and caregivers     on a 12-month period, and a follow up on a 12-month period.      100 patients with schizophrenia and 100 caregivers      Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test -     pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other     statistical approaches such as confirmatory factorial analysis, multilevel models and CART     method.   "
31893|NCT02868294|"     Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by     fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real     congenital osteoporosis. The prevalence of the disease is not known precisely, but it is 1 in     10000 at 20000. There are many forms of osteogenesis imperfecta to classify patients with     symptomatology minor to the patients with lethal form during the neonatal period. The main     symptoms are dominated by fractures and bone deformities, particularly in the lower limbs.     Bisphosphonate medication is used for over 10 years to reduce the number of fractures.     However the long-term effects are not known to date, not allowing even to establish proof of     the benefit risk. Thus unable to process all of these patients and over a long time, these     drug treatment leaves much therapeutic solutions to surgery. The goal of surgery is to treat     fractures, treat bone deformities and prevent fractures future. In the long bones of the     limbs, the only effective techniques are intramedullary nailing. The majority of realized     nailing nailing are either sliding or telescopic enabling having a reinforced bone of an     intramedullary osteosynthesis material over its entire length during the period of bone     growth. It has been shown that the technique of the sliding nailing was inexpensive but     reliable especially before the age of 5 years. After that age, all are telescopic nailing     nailing. The first telescopic nail described is the Bailey-Dubow nail still widely used in     France. However, the number of complications relating to its use is important. Thus, there     are 8% of disunity equipment and 33 to 72% of the nail migration forcing him to change one or     more times during growth. A new nail presented at the French orthopedic company in 2005 and     Fassier Duval reported a much lower complication rate because the rate of nail migration is     only 9%, without opening the knee joint, which is not possible with the highlight of     Bailey-Dubow.      It is proposed to conduct a prospective series of 10 nailing the lower extremities with this     nail Fassier-Duval in patients with osteogenesis imperfecta and compare the results with a     series of patients already treated with Bailey-Dubow nails in order to highlight the     advantages and disadvantages of using of such a nail.   "
31894|NCT02868281|"     This study is aimed to evaluate the effectiveness of Asthma Control Test (ACT) guided     treatment compared with usual care in asthma subjects in China. It is designed to assist     Chinese subjects and physicians improving adherence to the guidelines through the inclusion     of the ACT in the patient's asthma management plan. This is a prospective, multicentre,     cluster-randomized, open-label 24-week study. In this cluster-randomization design, each     study center, considered as a cluster, will be randomized to either ACT guided treatment     group or control group (usual care group). For the subjects who are recruited in the ACT     centers, they will be treated based on the ACT score. If ACT score are equal to (=) 25 for     more than equal to (>=) 3 months then the treatment will stepped-down; if ACT score >=20,     less than (<) 25 or ACT=25 for <3 months then there will be no change and if ACT score less     than (<=) 19 then the treatment will stepped-up. For subjects who are recruited in the     control centers, they will be treated based on doctor's subjective judgment. Assignment to a     treatment will not occur, as no treatment intervention is provided for this study. A total of     528 asthma subjects are planned in the study. The randomization will be stratified according     to the Tier of the hospitals (Tier 3 verses Tier 2).   "
31895|NCT02868268|"     This proposal sets forth the platform for a Precision Medicine clinical trial through the New     Approaches to Neuroblastoma Therapy (NANT) consortium. The plan is to utilize NANT's     established multi-institutional infrastructure and Translational Genomics Research Institute     GEM sequencing platform for acquisition and gene panel sequencing of relapsed biological     specimens in relapsed/refractory neuroblastoma (rNB) including those obtained from the bone,     bone marrow or soft tissue. Our primary aim is to identify subgroups of rNB patients who have     potentially targetable genetic (ALK, MAPK pathway, Metabolic-related genes) and/or     immunologic (tumor-associated macrophage infiltration and/or programmed death ligand [PD-L1]     expression) biomarkers in rNB. Additional potential novel biomarkers will also be evaluated     and reported in this cohort of patients.   "
31896|NCT02868255|"     project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a     new immunotherapy strategy in cancer.      Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be     used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal     Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.   "
31897|NCT02868242|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric     participants who are undergoing cancer chemotherapy.   "
31898|NCT02868229|"     This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,     pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo   "
31926|NCT02867865|"     Locally advanced Gall bladders cancers not amenable for curative resection are often treated     with chemotherapy alone which is the current standard of care. Randomized trials have shown     survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is     not common western world and thus there is lack of evidence regarding the impact of     neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with     chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo     R0 resection in few published studies. Also if the patients develop distant metastasis during     this neoadjuvant therapy they can be spared of unnecessary surgery.      In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated     with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability     rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35     and 20 months for the patients undergoing R0 resection.      In this study the investigators intend to compare the effects of using neoadjuvant     chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall     bladder cancers in terms of down staging and overall survival.   "
31899|NCT02868216|"     Stress, anger and depressed humor can operate as a trigger to an Acute Coronary Syndrome.1 It     is often found in the literature that patients refer excessive anger, anxiety, sadness, pain     or acute stress promptly before the acute myocardial infarction (AMI) onset, and recent     meta-analysis report a strong association between the occurrence of AMI and many of these     acute emotions.2 According to Mostofsky, Maclure, Tofler, Muller and Mittleman3 the risk of     suffering an AMI doubles after anger burst episodes when compared to another experienced     situations.      Anger is a common manifestation of psychological stress,4 and has been considered as an     hypothesis that this emotion could trigger off an atherogenic process through several     mechanisms.5-9 Evidences even suggest that hostile people that inhibit their anger expression     are more prone to develop coronary atherosclerosis.10      Coronary atherosclerosis features narrowing of coronary arteries on account of endothelial     thickening caused by the build up of atheromatous plaques.11 It is a process characterized by     inflammatory and fiberproliferative response of the artery wall, caused by continuous     aggression to its surface and whose thickening, evoked by the evolution of fat streaks     atherosclerotic lesions, until fiber plaques is quite slow.12      Vascular alterations present in atherosclerosis derive from some essential processes:     endothelial dysfunction, that has an early establishment and alters vase responsiveness,     leading to vessel constriction,13 coronary blood flood disorders, 13,14 atherosclerosis and     thrombosis evolution. Endothelial dysfunction also results in the loss of natural     anti-thrombotic properties involved in the endothelium patency.14      According to a study performed by our group in the Hemodynamics Sector of the Cardiology     Institute of Rio Grande do Sul and recently published in the International Journal of     Cardiology, anger management was significantly lower among patients with CAD when compared to     those without CAD, and the occurrence of major cardiovascular events (MACE) was significantly     higher in patients presented with lower anger control. Both associations were independent     from traditional risk factors, occurrence of previous events or another anger aspects.15     Thus, this study was designed in order to evaluate the effect of the cognitive training to     anger management and control on endothelium-dependent vasodilation of the arm artery in     patients with acute myocardial infarction with ST segment elevation submitted to primary     coronary intervention. Secondary objectives comprehend the assessment of the this treatment     influence on the incidence of recurrent cardiovascular events in these patients.   "
31900|NCT02868203|"     This study evaluates the completeness of strut coverage and vessel wall response, at     different time points (3-6-12 Months), following CordimaxTM stent implantation in patients     with non-ST elevation acute coronary syndrome   "
31901|NCT02868190|"     This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two     trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle     glaucoma on one topical hypotensive medication   "
31902|NCT02868177|"     Given the data on the active ingredients of Totum-63, this research aims to evaluate the     effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially     on fasting plasma glucose in volunteers with abdominal obesity associated with impaired     glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study     is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several     glucose and lipid homeostasis related parameters since these data are still unknown for this     specific dietary supplement formula. Collected data will provide more reliable information     which may be used to plan a subsequent larger main study.   "
31903|NCT02868164|"     The study will be conducted in the Department of Hepatology, Institute of Liver & Biliary     Sciences, New Delhi. As a part of this study history will be taken and clinical examination     will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis)     cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they     will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy     donor related or unrelated to the subjects and the stool will be prepared using standard     guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small     intestine by way of a thin and soft tube inserted through nose. This administration of     sample, 50 ml daily will occur once a month every month for 6 months. The liver function     parameters will be assessed and thereafter at 1 month and 3 months & subjects will be     clinically assessed for improvement or worsening.   "
37992|NCT02788357|"     This proposal evaluates the safety and effectiveness of a noradrenergic drug named     atomoxetine combined with motor training to enhance cortical plasticity and improve hand     function after stroke.   "
31906|NCT02868125|"     There is no standardized protocol regarding the post-operative radiographic follow up of     patients that sustain pertrochanteric hip fractures and are treated with closed reduction and     internal fixation. The policy in the investigator's institution as in other hospitals is to     conduct a radiogram of the operated hip during the first days following operation after the     patient bore weight on the fixated femur. The investigator's goal is to asses the added value     of this policy and to offer recommendations regarding this specific followup component.   "
31907|NCT02868112|"     The purpose of this research study is to pilot test a transdisciplinary intervention that     integrates both geriatrics and palliative care with routine oncology care for older adults     with incurable cancer. The investigators will explore their perceptions of the supportive     care needs of older patients with cancer. Using these data, the investigators will finalize     the transdisciplinary intervention and perform a pilot, randomized trial of the     transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed,     incurable cancer.   "
31908|NCT02868099|"     The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut     subjects with persistent or chronic primary immune thrombocytopenia (ITP).   "
31927|NCT02867852|"     Carcinomas of the salivary glands (SGCs) are rare tumors. Some selected salivary gland     histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise     specified) distinguish themselves for the expression of androgen receptors (AR), which is     reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen     deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or     disseminated AR-expressing disease. No other therapy except palliative chemotherapy is     available after progression on ADT, thus underling the necessity of alternative therapeutic     approaches.   "
31928|NCT02867839|"     The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin     versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with     locally advanced gastric cancer.   "
31929|NCT02867826|"     The aim of this study is to compare the visualization rates of the ampulla of Vater using     forward- viewing endoscopes with or without cap attached to the distal end in the same     patient.   "
31909|NCT02868086|"     The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of     public health. The therapeutic arsenal has widely grown throughout the years with the     emergence of intra-vitreous anti-angiogenic treatments, under different surveillance     protocols. The PRN surveillance (pro re nata: an on-demand treatment with monthly     follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain     the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular     signs of activity. The monitoring is done during common practice via OCT B scans showing     indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been     recently enriched with new programs allowing the visualization of sub-retinal neovessels     without the use dyes (OCT angiography). The OCT angiography is automatically done by a     program using standard OCT sections. During the monitoring of a patient using the OCT A, the     signs of renewed neovascular activity are represented by an arterialization or the     development of an arteriole network of the neovessel with the reappearance of a hyper     reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels     during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of     the injections). Knowing that the injection time-table of ARMD patients treated with     anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is     evaluated during routine clinical practice by very specific signs, observable on OCT B scans.     The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new     technic of image analysis performed on the OCT, may modify this injection time-table, with an     impact of the patient's visual acuity.   "
31910|NCT02868073|"     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the     Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN)     Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers   "
31911|NCT02868060|"     The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in     patients with immune thrombocytopenia.   "
31912|NCT02868047|"     There is tremendous variability in regard to provider perception of findings on EUS for     chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to     determine the validity of minimal standard criteria.   "
31913|NCT02868034|"     Research on spinal manipulative therapy for individuals with low back pain has been hampered     by a lack of understanding of which of the physiologic effects produced by spinal     manipulation are related to clinical benefit, and how these effects can be used to optimize     treatment outcomes. Prior research has identified physiologic effects that relate to the     clinical benefits from spinal manipulation treatment. The goal of this project is to examine     strategies to use these effects to identify optimized treatment protocols. The results of     this project will provide critical information for future clinical trials related to spinal     manipulation.   "
31914|NCT02868021|"     This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up     to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure     clinical outcomes such as strength, lower extremity function, and pain.   "
31915|NCT02868008|"     Microsurgical resection for eloquent arteriovenous malformations (AVMs) remains challenging.     Currently, there are only two grading systems concerning pretreatment assessment of brain     AVMs: the Spetzler-Martin grading system proposed by Spetzler and Martin in 1986 and the     supplementary grading system proposed by Lawton in 2010. Controversies exist regarding the     treatment timing and treatment modalities for eloquent AVMs. Till now, there is no clinical     trial concerning the efficacy of multimodal magnetic resonance imaging techniques in     assessing the surgical risk for eloquent AVMs. The investigators assume that multimodal     imaging-based grading system is superior to the classic Spetzler-Martin grading system and     the supplementary grading system in predicting the surgical risk for eloquent AVMs.   "
31916|NCT02867995|"     The purpose of this study is to determine whether glaucoma drop aids will be cost-effective     in delivery of ophthalmic medications by improving medication compliance, visual function,     and even decreasing medication waste in the patient population at Boston Medical Center   "
31920|NCT02867943|"     As an approximate of the difference between venous-to-arterial CO2 tension (∆PCO2), ∆PCO2 is     proportional to CO2 production and inversely related to cardiac output (Fick equation).     Anaerobic CO2 production is thought to occur when tissue hypoxia is present, mostly because     of buffering of bicarbonate ions by the protons produced in excess secondary to the     hydrolysis of adenosine triphosphate. Therefore ∆PCO2 has been proposed as a marker of tissue     hypoxia.   "
31921|NCT02867930|"     The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable     alternative for moderate sedation in out-patient diagnostic trans-esophageal     echocardiography.   "
31922|NCT02867917|"     The purpose of this study is to compare 1. taste and 2. texture/palatability of Metamucil     orange®, Volcolon® and generic orange psyllium.   "
31923|NCT02867904|"     The purpose of this study is to assess the efficacy of intra-operative subacromial     corticosteroid injections in patients undergoing arthroscopic shoulder surgery on quality of     life scores and activity level when compared to a control group.   "
31924|NCT02867891|"     In this trial the investigators will evaluate the outcomes of 4 pre‐defined groups of     individuals according to the therapeutic intervention. The investigators will determine the     outcome of each group by monitoring the survival and the response rates of patients with     FLT3-ITD AML relapse after allo-HSCT.   "
31930|NCT02867813|"     The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and     well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease     (CVD).   "
31935|NCT02867748|"     Abstract:      Urinary Stress Incontinence (USI)- is a discomforting condition that negatively affects the     quality of life of many female individuals and frequently treated by surgical intervention.     The incontinence curative operations revolutionized at 1995, with the introduction of the     first retro-pubic sub-mid urethral synthetic sling, firstly named Intra-Vaginal Sling-plasty     (IVS) and then Tension Free Vaginal Tape (TVT), by Ulmsten and Petros. This was later     proposed to be done trans-obturatorly (TOT), for avoiding operative bladder injuries.      Among other peri-operative complications attributed to the commonly used anti-incontinence     TOT are the thigh and groin pain. These pains are subjects of concern for patients and     physicians worldwide. Another, rare yet very disturbing post-operative complication is     erosion of the polypropylene tape into the vagina. TOT palpation at vaginal examination was     claimed to be a predictive sign for future erosion of the polypropylene tape into the vaginal     cavity.      This current study aims to compare TVT-Abbrevo procedure (12 cm polypropylene tape, Ethicon     J&J Somerville, NJ, USA ) to Serasis procedure (softly knitted monofilament non-absorbable     polypropylene, Serag-Wiessner, Naila, Germany) for the cure of USI. The purpose of this study     is to evaluate the feasibility, the safety and the cure rate of both procedures, as well as     documenting the post-operative immediate, and long term thigh and groin pain levels, and     dyspareunia. This study is aimed to evaluate the palpability of the implanted tapes at     vaginal examination and the possible relation of this to further vaginal tape exposure.      Investigators hypothesized that using Serasis tape, which is made of a softer polypropylene     material than rather rigid TVT-Abbrevo polypropylene tape might result in lower pain levels     at the short and long term post-operative course, as well as to reduced tape palpability and     exposure to the vaginal cavity. investigators believe that favorable results for this study     might improve patients' post-operative quality of life and overall satisfaction.      Keywords: Serasis, TVT-Abbrevo, USI, pain, groin, thigh, dyspareunia, safety, urinary stress     incontinence, sub mid urethral sling, trans-obturator, TOT, Intra-Vaginal-Sling plasty.   "
31936|NCT02867735|"     To evaluate the safety and tolerability of LKA651 in patients with macular edema from     diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal     vein occlusions (RVO)   "
31937|NCT02867722|"     In this study, daylight PDT will be administered to interested patients at     Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an effective     and painless alternative to traditional PDT. Daylight PDT involves application of the     photosensitizer in the physician's office followed by exposure to daylight.   "
31938|NCT02867709|"     This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25     and 50 mg) compared to placebo for the acute treatment of a single migraine attack.   "
31939|NCT02867696|"     The primary aim of this study is to examine the effect of applying a minimal contact     technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change     compared to Standard Care. Forty participants at 1-year post bariatric surgery will be     randomized to TECH or Standard Care for a period of 6 months (12 to 18 months post-surgery).     Analyses will be conducted to compare these interventions for differences in body weight,     body composition, fitness, physical activity, engagement, psychosocial measures, and     intervention cost and cost-effectiveness of each approach. TECH will consist of a wearable     monitor that provides feedback on energy expenditure and physical activity, electronic     tracking of dietary intake, and integration of an electronic scale to provide comprehensive     feedback to the participant on all components of weight management. TECH participants will     receive a monthly telephone call from the intervention staff to provide guidance on their     weight management efforts.   "
31941|NCT02867670|"     TMS is a non-invasive brain stimulation technique, which can be used to change the activity     of a person's brain cells without needles or surgery. In this study, the invesigators are     interested in the brain's ability to adapt (also called neuroplasticity) and regain     language functioning after a stroke—specifically, they want to determine whether how a     person's brain responds to TMS in the short term can be used to predict how well they will     recover language abilities in the long term.   "
31942|NCT02867657|"     The purpose of the study is to determine whether a five day mindfulness retreat in nature can     increase measures of attention and self-compassion, and reduce stress among bachelor students     at Danish Universities and University Colleges. Secondary whether the expression of     inflammatory markers can be reduced .      It is the hypothesis that perceived stress is reduced and the expression of genetic markers     of inflammation is reduced after a five day mindfulness retreat.   "
31943|NCT02867644|"     The hypothesis is to assess the contribution of conversational hypnosis on anxiety of     patients who undergoing for a preoperative breast tracking and improve their care   "
31955|NCT02867488|"     The objectives will be to evaluate the dose-response between the amount of soybean oil in     salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad     vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and     beta-carotene.   "
31956|NCT02867475|"     Study 1:      The investigator hypothesizes that the level of knowledge about the benefits of physical     activity, physical activity level and physical fatigue level observed in cancer patients,     would influence their beliefs about physical activity and their intention to engage in AP.   "
32524|NCT02860039|"     This phase II randomized trial studies how well high dose flu vaccine works in treating     children who have undergone done stem cell transplant. Higher dose flu vaccine may build a     better immune response and may provide better protection against the flu than the standard     vaccine.   "
31944|NCT02867631|"     The Postpartum Weight Management Study is a true community-academic collaboration, bringing     together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith     Wright from the University of Pennsylvania to address the needs of postpartum moms. The     project is an innovative intervention to help moms lose weight after the birth of their baby.     Helping mothers control their weight during pregnancy and beyond can help both mother and     baby avoid later obesity and cardiovascular disease. Although all women are at risk for     retaining the weight gained during pregnancy, this problem is amplified for low-income,     minority women. The holistic approach aims to prevent postpartum weight retention and     increase breastfeeding duration with a multi-component, low-cost intervention that provides:     1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a     baby carrier to combine exercise with infant care, and a pedometer to accurately measure     exercise at home; 3) Enhanced peer support, including home visits and group classes with     other mothers; and 4) Task-oriented professional support from nutrition and lactation     experts, who assist women in developing a personalized health plan. The effectiveness of the     intervention will be evaluated using a randomized control methodology among clients of MCC.   "
31945|NCT02867618|"     This is an open label, phase I/II, dose-escalation study in the initial phase I followed by a     phase II.      The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and     dose limiting toxicity (DLT) of the combinations of TGR-1202 and carfilzomib in participants     with relapsed and refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). The     safety and toxicity of this combination will be evaluated throughout the entire study.      If the combination of TGR-1202 and carfilzomib is found to be feasible and an MTD is     established, the phase II part of the study will be initiated.      Phase II will consist of a 2-stage design of the combination of TGR-1202 and carfilzomib for     participants with R/R NHL.   "
31946|NCT02867605|"     The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal     intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and     permeability, and to assess any health benefits and confirm the safety profile of HA35.   "
31947|NCT02867592|"     This phase II trial studies how well cabozantinib-s-malate works in treating younger patients     with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to     therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by     blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.   "
31948|NCT02867579|"     Described in the 1970's, pregnancy denial occurs as the un-consciousness of being pregnant     for several months or throughout the entire period. Body transformations are most of the time     not clearly noticeable. The prevalence of this symptom could represent 2 or 3 births over     1000. The definition of pregnancy denial remains unclear due to the different nosological     classifications used. There is no international consensus. Encountered terminologies are     different from on author to another: pregnancy denial, pregnancy negation. The difficulties     to define properly pregnancy denial accurately reflect the clinic heterogeneity of our     patients when practicing on a daily basis. As a result, it is difficult to find predictive     factors: any women of childbearing age, regardless her age, parity or social professional     category, can be subjected to pregnancy denial. Several publications report observations of     case of denial of pregnancy, few retrospective studies were realized, only two studies were     interested in the future of the child, and no prospective study was interested in the future     of the relation mother - child. The denial of pregnancy questions the maternal psychic     functioning. No link between psychiatric disorder and denial of pregnancy was until then     established. Our various clinical meetings, with mothers having presented a denial of     pregnancy and reporting a difficult personal history with many breaks and events susceptibly     traumatic, brought us to emit the following hypothesis: an insecure attachment of the mother     would participate or at least would facilitate in the construction of a denial of pregnancy.     These mothers would have a difficult access, even impossible for the infantile experiences,     the essential experiences in the psychic reorganizations of the pregnancy that prepare the     woman to accept her new functions of mother. The investigators hypothesize that the     attachment and the development of the child, as well as interactions mothers-babies are     disturbed when the woman presents a denial of pregnancy.      The research will compare the maternal functioning in both constituted groups (group denial     of pregnancy versus groups control), by estimating the type of maternal attachment, without     omitting to look for a possible psychiatric pathology, and a personality problem at the     mother.      From the questioning on the psychodynamic considerations of the denial of pregnancy, and also     on the future of the dyade mother-baby, the investigators construct a national program of     clinical research called Attachment and pregnancy denial, with the participation of 13     centers in France. This research is a prospective cohort examination with main objectives:     study the impact of the denial of pregnancy on the pattern of attachment of the child, on the     interactions of dyads mother-child and on the early development of the child with a 20-month     follow-up. It's a multicenter case-control study with 13 centers (Reims, Strasbourg,     Besançon, Nancy, Toulouse, Amiens, Troyes, Toulon, Limoges, Ile-de-France, Lille, Bordeaux,     Paris 18ème), to find the maternal risks factors associated to pregnancy denial (secondary     objectives).      The main objectives of this study are: (i) studying the relationship between pregnancy denial     and the attachment pattern of the child; (ii) studying the relationship between pregnancy     denial and the early interactions of mother-infant dyads; (iii) studying the relationship     between pregnancy denial and the early development of the child.      The secondary objectives of this study are: (i) studying the relationship between the     duration period from the pregnancy announcement to the delivery and the early development of     a child, including the attachment pattern of a child, the early interactions of mother-infant     dyads, (ii) looking for the risk factors associated to pregnancy denial, including the type     of attachment, the existence of a personality disorders and/or a psychiatric pathology   "
31949|NCT02867566|"     The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP     in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.   "
31950|NCT02867553|"     Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A     quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B cell     lymphomas. These indolent cutaneous B cell lymphomas are characterized by good prognosis     (survival rate at 5 years: 90%), but also by the frequency of cutaneous recurrences. The     radiotherapy is currently the most widely used treatment, with complete response rate close     to 100% for a lesion treated. However, it has limits when there are outset multiple lesions     inaccessible to a single radiotherapy field (concerning one case in three), or during     recurrences. In these situations, conventional chemotherapy is not recommended and     multi-field radiotherapy is often used empirically, but its effectiveness has never been     studied prospectively.      Recently, retrospective studies with small numbers patients (totaling sixty patients)     reported complete response rates of 80 to 100% with rituximab (anti-cluster of     differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized     treatment by intravenous with a recurrence rate of less than one case in three. These data     suggest that rituximab by intravenous with a standardized initial cycle followed by a     maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with     multiple lesions or of recurrent lesions.   "
31951|NCT02867540|"     Nearly three-quarters of patients with Crohn's disease have small bowel involvement and 80%     of them will have complications that will require a surgical procedure, usually an     ileocolonic resection with ileocolonic anastomosis. The rate of recurrence at the anastomosis     site and in the ileum after surgery, whether symptomatic or not, is high, at least 60% in one     year and 80% within three years. The gold standard for monitoring being ileocolonoscopy,     endoscopic surveillance is recommended in these patients, once between 6 to 12 months after     surgery and then every 2 years.      The MRI enterography is a validated technique for the assessment of small bowel Crohn's     disease. The enterography MRI is a validated technique for the assessment of small bowel     Crohn's disease. The MRI enteroclysis was evaluated in two studies compared to endoscopy,     with excellent performance in terms of recurrence detection sensitivity and suggested as an     alternative to it to avoid an invasive procedure repeated in these patients. The MRI     enterography (without enteroclysis) does not provide as good distension of the bowel loops as     MRI enteroclysis because it relies on the principle of oral ingestion prior to the     examination of large amounts of liquid. However, it is much better tolerated by the patient,     does not involve radiation that exists with enteroclysis, is much simpler to use and requires     no special equipment to magnetic fields.   "
31952|NCT02867527|"     Few publications provide information on the natural history of glaucoma, outside of clinical     trials do not always reflect what is observed in common situation for various reasons     (specific selection criteria and sometimes restrictive, stronger motivations patients and     physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much     information on the natural history of glaucoma are unknown to date (degradation rate of     visual field and visual function over time, risk of blindness in the years following     diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual     field deterioration, etc.). Obtaining such important data to improve the management of     glaucoma patients (choice of treatment methods, identification of predictors of rapid change     that can make choosing more aggressive treatment and more regular monitoring, etc.) requires     the establishment of cohort of patients followed and treated with the methods usually used in     current practice, and besides therapeutic trial.   "
32049|NCT02866266|"     Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency     Department visits and hospitalizations for overdose/poisoning and death among patients     prescribed ER/LA opioid analgesics.   "
31957|NCT02867462|"     The medical teams are increasingly sought by patients to get the most possible information,     probably expressed in a different form and thereby supplementing the information already     received. Coulter et al. reached similar conclusions in their study of the writings of     patient information documents. They point out, moreover, the best adaptation of the patients     better informed compared to those with less or no information.      This need for information varies over time. It is present before treatment begins, continues     during treatment and persists after treatment. Given the specific features of radiotherapy,     the manipulators are important interlocutors to participate in the accompanying caregiver     time.      In conclusion, the quality of information delivered to the patient has been poorly evaluated,     let alone with validated tools in this area.      The impact of information on the tolerance of the treatment also needs to be confirmed,     knowing that an informed patient seems less anxious and better prepared for future treatment.   "
31985|NCT02867098|"     An open label comparison of concentration of the study medication administered intravenously     (IV) versus subcutaneously (SC) in healthy volunteers.   "
32076|NCT02865915|"     This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of     MLE4901 versus placebo in women with PCOS.   "
31958|NCT02867449|"     Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.     However, the majority of treated patients remain symptomatic. The metacognitive therapy by     Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this     study is to investigate this approach with a randomized controlled trial by comparing     metacognitive therapy with exposure and response prevention for obsessive-compulsive     disorder.   "
31959|NCT02867436|"     The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in     children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell     function as compared to age matched controls. Primary objective of the trial is the change in     C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on     GFD and standard gluten-containing diet.      Secondary objectives are:        -  Changes in immune parameters between gluten-free diet group and control group;        -  Differences in fecal microbiome between children on normal diet and children on GFD;   "
31960|NCT02867423|"     The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an     industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an     interest in irradiation (boost) of tumor site after conventional irradiation. The radiation     boost is currently issued by electrons, protons or brachytherapy. These techniques require     several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has     an interest in reducing the number of fractions and a reduction of dose delivered to the     skin.      CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for     inoperable breast tumors and has proven its effectiveness and safety of treatments.      The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays     issued by CK for boost to the tumor site after conventional breast irradiation.      The results, in terms of local control, will be evaluated on clinical monitoring.   "
31961|NCT02867410|"     Feeding problems are common among babies who are born preterm or who have medical conditions.     It is not yet known which babies admitted to neonatal units are most at risk of feeding     problems. Studies have shown that the degree of prematurity and the presence of additional     health problems make feeding difficulties more likely. However, research does not always     agree on which health problems are most associated with feeding problems and many studies on     prematurity exclude babies with the most complex health problems. Additionally, not all     babies with complex health problems and feeding problems are premature. This study aims to     answer the question 'Is gestational age or medical status the better indicator of risk for     feeding difficulties?'      This research will study babies admitted to the Royal Preston Hospital Neonatal Unit in 2015     using routinely collected data about stored on BadgerNet, a patient data management system.     Coded data will be collected for the following variables: gestational age category (extremely     preterm, very preterm, moderate-late preterm, term), medical status by number and type of     bodily systems with health issues, and feeding outcome (full oral feeding by 37 weeks, 40     weeks, before discharge, or discharged home with tube feeding).      Appropriate statistical tests will be used to determine the presence or absence of     correlation between gestation age and medical variables and feeding outcome. Information from     this study will be used to inform neonatal service delivery (including Speech and Language     Therapy referral criteria and caseload prioritization) and areas in need of further research.   "
31962|NCT02867397|"     The goal of the current study was to investigate the safety and determine the maximum     tolerated dose (MTD) of S-1 in combination with oxaliplatin and epirubicin in patients with     advanced or metastatic solid tumors.   "
31963|NCT02867384|"     This research study is studying a drug called obinutuzumab as a means of preventing chronic     Graft vs. Host Disease (cGVHD).   "
31964|NCT02867371|"     The Archimedes System is an image-guided navigation system used to access tissue samples in     the lungs. This study is being conducted to confirm the performance of the Archimedes System     in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung     cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor     is conducted.   "
31965|NCT02867358|"     The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation     of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains,     fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.   "
31966|NCT02867345|"     This study will evaluate the safety of PD-1 knockout engineered T cells in treating     castration resistant prostate cancer (CRPC). Blood samples will also be collected for     research purposes.   "
31967|NCT02867332|"     This study will evaluate the safety of PD-1 knockout engineered T cells in treating     metastatic advanced renal cancer. Blood samples will also be collected for research purposes.   "
31968|NCT02867319|"     This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide     vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and     active surveillance.   "
39223|NCT02772237|"     The purpose of this study is to investigate the effectiveness of riboflavin to decrease the     duration of time for a student-athlete to return to participation in sports after a sports     related concussion.   "
31969|NCT02867306|"     The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the     pharmacokinetics of once weekly oral methotrexate (MTX).      This study will also evaluate the effect of MTX on multiple-dose pharmacokinetics of ASP1707,     as well as safety and tolerability of coadministration of ASP1707 and MTX in patients with     rheumatoid arthritis (RA).   "
31970|NCT02867293|"     Massive ascites is usually controlled over several weeks pre-operatively in liver transplant     recipients with the risk of encephalopathy and peritonitis. We hypothesized that     intra-operative drainage of ascites will be safe and avoids the inherent risks of     pre-operative drainage.   "
31971|NCT02867280|"     This prospective multicenter non-randomized controlled study evaluates the efficacy and     safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with     microvascular invasion after radical resection compared to conventional therapies.   "
31972|NCT02867267|"     The purpose of this study is to determine whether thymalfasin is safe and effective in     patients who have sepsis   "
31986|NCT02867085|"     The prospective BoHemE study is designed to evaluate the correlation between bone marrow     function and skeletal health in elderly patients (>= 60 years) with or without pre-existing     myelodysplastic syndromes (MDS).   "
39708|NCT02765867|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile     of an injection of RBP-6000.   "
31973|NCT02867254|"     Pulpal and periodontal tissues are closely related and have similar microbiota that     cross-contamination between the pulp and periodontal tissues.The aim of this study was to     investigate the prevalence of isolated Candida albicans from periodontal endodontic lesions     in diabetic and normoglycemic patients and their virulence in different atmospheric     conditions. A case-control study was conducted on 15 patients with type 2 diabetes mellitus     (G1) and 15 non-diabetics (G2), with periodontal endodontic lesions. Samples of root canals     and periodontal pockets were plated on CHROMagar for later identification by polymerase chain     reaction (PCR) and virulence test.   "
31974|NCT02867241|"     The primary goal of this research is to evaluate the effectiveness of an intervention for     parents to reduce tobacco smoke exposure of young children   "
31975|NCT02867228|"     This study will evaluate the correlation between invasively measured parameters (work of     breathing/power of breathing, resistance and elastance), derived using esophageal pressure     measurements, and their corresponding non-invasive estimated values (noninvasive work of     breathing/power of breathing, resistance and elastance), computed using airway pressure and     flow measurements only.   "
31976|NCT02867215|"     The aim of this study was to compare the metabolic effects of consuming whole barley bread     and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain     flour on mineral status.   "
31977|NCT02867202|"     This study was taken out to compare two mechanical devices (intrauterine balloon and     intrauterine contraceptive device) in the therapy for intrauterine adhesions after     hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.   "
31978|NCT02867189|"     Aims and objectives The purpose of this study was to develop an atlas to explore the effect     of micro-instrument cleaning on the safety of cataract surgery.      Background Cataract surgery safety is affected by many factors, the most influential of which     is the quality of instrument cleaning. Previous studies focused on the reaction in the eye     after cataract surgery. None offered a solution for manually cleaning ophthalmic     micro-instruments or response data for surgical instruments after cataract surgery.      Design The study was designed to collect quantitative data derived from postoperative ocular     evaluation.      Methods We developed an atlas that details micro-instrument cleaning that could be used to     train nurses to have this skill. A total of 120 cataract patients were divided evenly into     experimental and control groups. In the experimental group, cataract surgery was undertaken     using microsurgical instruments that were cleaned by the atlas-trained nurses. In the control     group, micro-instruments were used that had been cleaned by non-atlas-trained nurses. All the     patients underwent the same postoperative tests: anterior chamber cell counts and visual and     intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.   "
31979|NCT02867176|"     This is a prospective, randomized, single blind study. Patients enrolled in the study were     randomly assigned to a ketorolac or a gabapentin group for pain control. Different pain     scores and variables will be evaluated, along with others side effects variables.   "
31980|NCT02867163|"     This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in     total knee replacement patients who received an intraoperative dose of tranexamic acid.   "
31981|NCT02867150|"     The purpose of this study is to determine whether red light therapy using LED 635nm red light     for body contouring of the waist, hips and thighs is as effective as red light therapy using     Laser 635nm red light.   "
31982|NCT02867137|"     The PreTBI I study will investigate whether prehospital blood samples drawn already in the     ambulance can rule-out intracranial lesions in patients suffering head trauma. The study aims     to improve triage and treatment of patients suffering mild head trauma, who are considered     low-risk patients. These patients do not always benefit from hospitalization, but are     nevertheless admitted on precaution, as clinical assesment can be difficult.      Hypotheses:        1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules          out traumatic intracranial lesion with a sensitivity >97%.        2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI          patients rules out traumatic intracranial lesion with sensitivity >97% and results in          lower false positive rate than S100B.        3. Prehospital measurements of both GFAP and S100B results in lower false positive rates          than in-hospital measurements.   "
31983|NCT02867124|"     This proposed five-year study will focus on whether the addition of providing XR-NTX     treatment at a patients' place of residence will increase adherence and thus efficacy of the     medication.Following initial screening, informed consent, and medical examination,     pre-release prisoners at each facility will be block randomized (N=240) within gender to     either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six     monthly injections post-release in the community at an opioid treatment program; or Condition     2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections     post-release in the community at the patient's place of residence.   "
31984|NCT02867111|"     Infertility is considered a disease by the World Health Organization, and it is increasing     worldwide, affecting more than 70 million couples. About 50% of the cases are due to male     inability to fertilize the oocyte. In the last 40 years, several techniques, known as     Assisted Reproduction Technology (ART) have been developed to treat infertility, but the     efficiency is still relatively low (around 30% of success) whereas the remaining 70% attempts     again several times, an expensive and emotionally moving treatment. Over 4million of     infertility treatments are practiced around the world per year and a 50% increment is     expected over the next 6years. Even though ART allows the birth of babies that would be     impossible under natural circumstances, it is still necessary to improve the procedures in     order to increase treatment efficiency. The success of ART depends, to some extent, on sperm     quality. Indeed, the relevance of spermatozoa quality is notorious even beyond fertilization,     extending to embryo development and implantation. In this context, it has been developed a     new technology that allows the selection of those spermatozoa at their best functional state     (Sperm Selection Assay, SSA; Patent approved for USA and Europe, pending for Japan and     Argentina). This method is based on the attraction of spermatozoa ready to fertilize the egg,     towards a physiological attractant molecule. The SSA may be applied to improve diagnosis and     infertility treatment. The investigators hypothesis states that the use of the SSA will     improve the number of good-quality embryos which are the ones to be transferred by     intracytoplasmic sperm injection (ICSI), providing a healthy embryo development. The protocol     involves three experimental groups where the SSA will be used or not, before performing the     ICSI: 1)SSA containing the sperm attractant molecule, 2)SSA without the attractant molecule,     and 3)without SSA. The patient inclusion criteria involve female factors associated to tubal     obstruction and/or endometriosis and male factors associated to sperm disability. Several     outcome parameters will be determined, the percentage of fertilization, embryo quality, rate     of pregnancy and rate of birth. The study will be carried out in the Universitarian Institute     of Reproductive Medicine (IUMER) which has been recently established in a public hospital     depending on the National University of Córdoba, offering free high complexity infertility     treatment to patients without health insurance or economic support   "
31987|NCT02867072|"     Appendectomy is the most common surgical procedure performed in emergency surgery. Because of     lack of consensus about the most appropriate technique, appendectomy is still being performed     by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the     investigators aimed to compare the laparoscopic approach and the conventional technique in     the treatment of acute appendicitis.   "
31988|NCT02867059|"     This is a single-centre, open-label, study using induced blood stage malaria (IBSM) infection     to characterize the activity of (+)-SJ000557733 or SJ733 for short, against early Plasmodium     falciparum blood stage infection. The study will be conducted in two cohorts (n=8 per     cohort). The anticipated efficacious dose range is expected to be within a range of 125 to     600 mg. The dose used in the first cohort was determined on the basis of the safety and PK     data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and     will be 150 mg. Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia)     obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600     mg. Based on the PK from all three cohort from the FIM study, the median estimated dose to     obtain the target SJ733 AUC of 13,000 (ug hr/L) is 370 mg. The dose of cohort 2 (≤600mg) is     intended to provide further concentration-response information in the human challenge model.      For Cohort 2 only, a second dose of SJ733 may be administered at peak gametocytaemia to     assess if SJ733 can reduce gametocytes and subsequent infectivity to mosquitoes (a washout of     ~15 days post initial SJ733 treatment will be observed). Depending on the data obtained from     the first two cohorts, there may be a subsequent cohort, with the investigated dose of SJ733     to be determined by the Sponsor and Principal Investigator (PI) and endorsed by the Safety     Review Team. Should this third dose be investigated, a substantial amendment including     preliminary data from the first two cohorts will be submitted to the HREC for approval.   "
31989|NCT02867046|"     Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of     lumbosacral radicular pain, but in case of intravascular injection, infrequently serious     complication can be developed. Against this backdrop, if there is any difference of frequency     of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial     approach and method using lateral approach in anteroposterior view, the result can be crucial     factor in selecting the approach. In addition, appropriate volume of injection will be     checked in each approach.   "
31990|NCT02867033|"     The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.   "
31991|NCT02867020|"     Evaluation of the activity, safety and patients reported outcome of ADT plus abiraterone,     abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone in     hormone naïve locally advanced or metastatic prostate cancer which ADT was indicated.   "
31992|NCT02867007|"     The purpose of this study is to characterize the safety, tolerability, and determine the     maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of     exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to     subjects with locally advanced or metastatic solid tumors.   "
31993|NCT02866994|"     This randomized comparative effectiveness trial examines the potential psychosocial and     physical health-related benefits of sharing personal websites with other women with breast     cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family     and friends only (PCO condition) in a sample of women with metastatic breast cancer.   "
31994|NCT02866981|"     The purpose of this registry is to determine if select patients with CNS metastatic disease     can be safely observed rather than treated. The investigators hypothesize that there is a     subset of patients with small asymptomatic CNS mets that do not require treatment, these     patients can simply be observed and will not have CNS progression.   "
31995|NCT02866968|"     The study will be a pilot interventional case series aiming to treat 30 patients with     Femtosecond Laser-assisted Pterygium Surgery (FLAPS). All patients included will undergo     FLAPS in one eye. All procedures will be performed in SNEC by fully qualified surgeons. The     doctor is informed of the procedure on the day of.   "
31996|NCT02866955|"     Despite advances in early detection and treatment strategy, about 25 to 40% of patients     treated for breast cancer develop metastasis.      Some patients are in a therapeutic impasse situation. It is therefore necessary to consider     all possible options. The Estramustine showed encouraging results in the treatment of     metastatic breast cancer.      Given the clinical data, the answer rate of Estramustine and its impact on progression free     survival deserve to be studied in earlier clinical situation.      This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and     metastates, already treated with aromatase inhibitors and for whom this treatment has failed.   "
32063|NCT02866084|"     This is a non-randomized pilot study to test the efficacy of neuromodulation via caloric     stimulation on vestibular migraines. All subject who meet the study criteria will be in an     active treatment group. All subjects will report the frequency of the migraines and undergo     periodic testing of symptoms.   "
31997|NCT02866942|"     A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been     approved by a number of licensing boards and is given by a spray into the nose. In the United     Kingdom (UK), the vaccine has been demonstrated to be highly effective against influenza     infection. Further, despite concerns that LAIV can cause wheezing in children under age 2     years, the previous SNIFFLE studies have demonstrated it to be safe in children over 2 years     with mild-moderate asthma.      The objective of this multicentre study is to further assess the safety of intranasal LAIV in     children with asthma and recurrent wheeze, including those with severe symptoms.   "
31998|NCT02866929|"     Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged     in the past few years as an appealing alternative for patients and practitioners. In the     context of a thin biotype, these approaches pose a burden that could precipitate periodontal     detrimental changes. Therefore, case selection and the implementation of periodontal biotype     enhancing strategies become a relevant consideration to ensure long-term successful treatment     outcomes. This study focuses on the biological and clinical value of the use of a porcine     naturally cross-linked collagen matrix known as Mucograft®. Within the scope of Surgically     Accelerated Orthodontic Treatment (SAOT) the structural and material features of Mucograft®     provide: 1) A protective effect to the thin biotype upon rapid orthodontic     protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect     that supports an increase on tooth movement rate. The designs of this randomized controlled     clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho     tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho     tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements     will capture the clinical phenotype; while the biologic phenotype will be derived from     evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and     Interleukin-1RA. The significance and innovative value of this proposal stems from the use of     Mucograft® as an ideal collagen-based biotype enhancer when performed along with the     corticotomy. This approach could prove to be effective to further increase the therapeutic     window that allows accelerating orthodontic treatment and, at the same time, could decrease     the recession risk in movements of proclination of antero-inferior incisors. Besides, the use     of a collagen scaffold alone could potentially trigger a comparable orthodontic acceleratory     outcome that could be evaluated as an alternative to decortication.   "
31999|NCT02866916|"     This is a single site, open-label, non-randomized, dose escalation phase I study designed to     evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a     synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger     RNA (mRNA), in patients with metastatic castration-resistant prostate cancer.      A standard method 3+3 will be used for dose escalation. A maximum of 30 patients will     complete the dose-escalation phase of the study; 12 additional patients will be included at     the RP2D in the expansion phase.   "
32000|NCT02866903|"     Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of     rare primary peritoneal cancers, or more frequently distant extension of digestive cancers     (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can be     considered as a distinct oncological entity as its genesis, natural history, and response to     systematic treatments differ to those of other metastases. The development of PC, observed in     25-35% of colorectal cancers, is generally considered as a unfavorable event in the course of     the disease. The prognosis is defined by the possibility of complete resection, possibly     after neoadjuvant treatment. The benefit provided by the combination of cytoreductive surgery     and heated intraperitoneal chemotherapy (HIPEC) with respect to systemic chemotherapy in     patients with PC of colorectal origin has been demonstrated based on overall survival in     several randomized trials, among which one evaluated oxaliplatin. The evaluation of the     clinical benefit-risk related to the repeated administration of non-hyperthermic     intraperitoneal chemotherapy, as has been validated in ovarian cancer, in patients with PC of     colorectal origin is already being investigated by several international teams.      The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with     this disease. The intraperitoneal rather than intravenous (IV) administration of oxaliplatin,     in this combination, could increase the response of peritoneal lesions known to be relatively     insensitive to IV chemotherapy.   "
32001|NCT02866890|"     The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural     changes in design. As these changes may influence the performance of the LTS-D relative to     the old LTS-D version the investigator decided to check the new LTS-D in the pediatric     version The investigator hypothesized that the LTS-D perform clinically well during general     anesthesia with controlled ventilation.   "
32002|NCT02866877|"     This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients     who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development     of augmented renal clearance and the effects and duration of effects this may have on     levetiracetam clearance.   "
32003|NCT02866864|"     The investigators will evaluate sensitization to animal allergens and allergic symptom during     contacting animal allergens in Korean veterinary researchers who attend their annual     conference.      The investigators will compare sensitization to animal allergen and other clinical and     occupational factors between subjects who suffer from allergic symptom during contacting     animal and those who do not.   "
32004|NCT02866851|"     Patients should receive a chemotherapy regimen with an overall risk of febrile neutropenia ≥     20%. The use of the web-application their will be proposed .      They will be informed of the risk of neutropenia, fever and bleeding which may occur beyond     the fifth day of each chemotherapy cycle (to eliminate fevers related to treatment).      The temperature measurement is performed at home by an infrared forehead thermometer provided     as part of the study, in a systematic manner once daily at the same time of day and in case     of unexplained fatigue or chills.      Before any fever reported to the physician via the web-application (alert), a questionnaire     will be completed by the patient to the search for gravity criteria to assess his condition     at home. The patient will be hospitalized immediately if it shows signs of severity in order     to document the infection and provide intravenous antibiotics adapted to the clinical     condition; in the absence of these signs, the patient will make a count to the nearest lab     and will receive oral antibiotics if indicated. The subsequent strategy will be defined by     the web-application algorithm to optimize the care of patients.      The ability to use a web-application could allow early detection of complications of     post-chemotherapy haematological toxicity and offer a taking over guided by a decision-making     algorithm managed by the physician.      The aim is to favour the taking over at home.   "
32064|NCT02866071|"     STUDY SYNOPSIS Objectives The primary objective is to estimate the proportion of subjects who     report clinically important reductions in pain score (defined as 2 points on a 0-10 verbal     numerical rating scale) after receiving fentanyl (50mcg) with or without intranasal (IN)     ketamine (50mg) prior to hospital arrival for the treatment of acute traumatic pain.      Design and Outcomes This is a prospective, randomized, placebo-controlled single-site     clinical trial. The primary outcome variable is reduction of reported pain of at least 2     points (on the 0-10 Verbal Numerical Rating Scale1,2) when comparing the pretreatment pain     score to the pain score obtained upon reassessment 30 minutes after medication     administration. Secondary outcomes include: reduction of reported pain at Emergency     Department (ED) arrival; the incidence of adverse events; additional opiate requirements     prior to ED arrival and in the first three hours of ED care; development of chronic pain     (measured by the Brief Pain Inventory,3) or post-traumatic stress disorder (measured by the     PTSD Checklist for DSM-54) and overall satisfaction with life (measured by the Satisfaction     With Life Scale5) at 90-days after injury.      Interventions and Duration Adults who qualify for prehospital pain treatment under paramedic     standing orders will be screened for inclusion and, if eligible, will undergo an IRB-approved     consent process concurrent with receiving 50mcg fentanyl (IV or IN per current standard     practice). Consenting subjects will be 1:1 randomized to receive either 50mg IN ketamine or     IN placebo. Pain will be rated on a 0-10 scale by the subject prior to treatment, at 30     minutes following treatment, at ED arrival, and at 30 minute intervals for the first three     hours of their ED care. Additional pain medications given prior to hospital arrival and     within the first three hours of ED care will also be recorded. The primary outcome will be     reduction in baseline pain between the pretreatment measurement and 30 minutes after     medication administration. Overall satisfaction with life and symptoms of PTSD and chronic     pain will be assessed before hospital disposition (in-person) and via phone follow-up at     90-days (+/- 14 days) after injury.      Sample size and Power The Investigators consider a two point reduction in pain to be     clinically significant, and thus will compare the proportion of subjects achieving a two     point reduction in pain at 30 minutes post-medication administration between the treatment     group and the control group. Sample size considerations are based on this primary analysis.     To test the hypothesis that the proportion of those treated with fentanyl alone that have at     least a 2 point reduction in their pain will be lower than the proportion of those treated     with the combination of fentanyl and single-dose ketamine who have a 2 point reduction in     their pain, the investigators will use a chi-square test (or the Fisher's Exact Test if     appropriate). An intent to treat approach will be used. It is expected the response rate in     the two groups will be 40% and 60%, respectively. These estimates are based on the response     rates in a study comparing pain management efficacy between subjects treated with morphine     alone and morphine plus ketamine. With this magnitude of effect, a sample size of 97 per     group will have 80% power to detect the difference between the two groups when the critical     level of significance is set to 5%. To allow for subject drop-out, protocol deviations, and     missing outcome data, the investigators plan to enroll an additional 15% in each arm, for a     total of 224 subjects.   "
32065|NCT02866058|"     This study will examine the effect of cesarean section on perinatal mortality, using data     provided by the Canadian Institute for Health Information.   "
32005|NCT02866838|"     Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the     coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors     apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of     NOAC treatment (NOAC-ICH).      Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is     no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable     outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of     bleeding conditions other than ICH.   "
32006|NCT02866825|"     The trial enrolls patients undergoing a complex cardiac surgery. The primary goal of the     trial is to evaluate the pharmacodynamic dose response relationship of the monoclonal     antibody IFX-1 in these patients. In addition, this trial further aims to characterize the     safety and the pharmacokinetics of IFX-1 as well as to collect first data on its efficacy on     clinical surrogate endpoints.   "
32014|NCT02866721|"     This study is being done to test if it is safe to give stem cells to adult patients with     Cystic Fibrosis (CF). The kind of stem cells we are studying are called allogeneic human     mesenchymal stem cells or MSCs. MSCs are cells in the body that can grow into different types     of cells and respond to various environmental situations. Allogeneic means the cells come     from another person (a donor).      This study is only looking at whether or not it is safe to give the stem cells to adults with     CF and how the infusion is tolerated. In the future, other studies may be done to see if stem     cells can be a new therapeutic treatment for CF.      Stem cells, like other medical products that are intended to treat, cure or prevent disease,     generally require approval from the U.S. Food and Drug Administration (FDA) before they can     be marketed. The FDA has not approved any stem cell-based products for usual medical care,     other than some specific blood forming stem cells for certain indications.   "
32037|NCT02866422|"     To support the discovery of new means for revealing the presence of Obsessive Compulsive     Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to     automate existing diagnostic procedures allowing for more efficient diagnostic methods that     would broaden clinical scope and outreach.   "
32007|NCT02866812|"     During the last decade, the embolization has become the treatment of choice for ruptured     intracranial aneurysms, to improve the neurological outcome of patients. At the same time,     for his safety, she also became the technique allowing prophylactic treatment of unruptured     intracranial aneurysms discovered incidentally during imaging exams.      Regarding patients with ruptured intracranial aneurysms, patients who survive often have a     reduced quality of life while one in two has a good neurological outcome after embolization.     Depression, anxiety and fatigue, whose the psycho-social impact is important, are often     cited. This description has often been done without considering the realized type of     treatment (surgery or embolization) and mostly of neurological and functional status of the     patient remotely (disability or not in daily activities).      Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and     embolization is programmed. They would present an cognitive impairment in one case in five at     1 month of treatment.      If depression, fatigue and difficult return to working life are logically found in patients     with severe sequelae (disability in daily activities) of their ruptured intracranial     aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a     favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms.      A precise status of these populations is necessary, especially as the discovery and treatment     of their intracranial aneurysms is often early (between 40 and 60 years) and that their good     neurological status should allow a priori to return easily at the active life.   "
32008|NCT02866799|"     This study assesses the effectiveness of a complex intervention in young-old patients with     multimorbidity and polypharmacy aimed at improving physician drug prescription in primary     care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and     12 (T2) months from baseline compared to usual care.   "
32009|NCT02866786|"     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorder in women of     reproductive age and is a leading cause of infertility due to anovulation. Oral contraceptive     pills (OCPs) are considered as first line medical therapy to regularize menses in woman with     PCOS. However they may worsen the metabolic profile of patients by elevating insulin     resistance which is already deranged in PCOS. As there is higher prevalence of insulin     resistance in Indian women with PCOS, insulin sensitisers like metformin may be more     beneficial. Hence this study is undertaken to compare the combined effect of metformin and     OCPs on the clinical, hormonal, metabolic and ovarian ultrasonographic characteristics in     patients with PCOS and to evaluate whether this combination of drugs is more advantageous     than OCPs or metformin alone in improving the clinical and metabolic profile.   "
32010|NCT02866773|"     In Hong Kong, nearly 40% of adults were overweight or obese, and about 60% of total     registered deaths were due to four major preventable non-communicable diseases. Many     residents are lack of attention to personal healthy lifestyle and family holistic health.     This project focuses particularly on the promotion of healthy diet and physical activities     enhancement in families through the well-established community network of the Hong Kong     Island Women Association (HKIWA). This project includes three major components:     Train-the-trainer and -ambassador workshop, community-based family interventions, and public     education events. It is expected that knowledge and skills of the community leaders and     ambassadors are strengthened through the 'Train-the-trainer and -ambassador' (TTTA)     workshops. Furthermore, they are expected to help the implementation of community-based     family interventions and public education events on the personal and family holistic health     of the community participants.   "
32011|NCT02866760|"     This study aims at understanding the needs and concerns of Chinese current smoking patients,     including their risk perceptions, and the behavior, attitudes, and experiences related to     smoking and smoking cessation. Specifically, how smokers overcome withdrawal symptoms and     cigarette cravings, as a result of banning on smoking in hospitals, will be explored. In     addition, whether smokers will stop, resume or continue smoking after hospitalization will be     investigated.   "
32371|NCT02862028|"     Objectives:      To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat     relapsed or refractory cancer.      Eligibility:      Individuals greater than or equal to 18 years of age and less than or equal to 70 years of     age who have been diagnosed with relapsed or refractory cancer that has not responded to or     has relapsed after standard treatment.   "
32012|NCT02866747|"     This study is a phase I/II, national, multicenter, open-label study starting with a Phase I     part followed by a Phase II part.      The phase I part of the study aims to evaluate the safety of the association of     hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab     immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will     be enrolled in this phase I part.      Once the recommended combination schema will be declared, patients will be enrolled in the     Phase II part of the study in order to evaluate the efficacy (local control rate) of the     combined treatment in recurrent glioblastoma. In this Phase II part, patients will be     assigned by randomization to one of the two following arms:        -  Arm A (control arm): Radiation therapy alone (17 patients)        -  Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab (33 patients)   "
32013|NCT02866734|"     Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic     retinopathy (DR) is one of the most common complications of DM. Screening for DR is a     cost-effective method to identify patients who are at risk of vision loss so that timely     treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set     up screening services (RAMP) in the government outpatient clinics and all DM patients     attending these clinics will be screened at least once every two years and some every six     months, according to their individual risks. However, those diabetic patients who attend the     private sector for their primary care may not have access to this service.      Aim: This study from the University of Hong Kong aims to determine the characteristics of a     sustainable approach to setting up an effective and quality-controlled screening service for     DR in the private primary care sector of Hong Kong and to estimate the potential benefit to     be gained in terms of impact on avoidable vision loss, costs of care and potential for     further development of this model in chronic disease care.      Methods:A screening centre is being set up and a randomised study carried out in which     screening will be offered at three different fee levels to subjects recruited by their     general practitioner (GP). The following data will be collected (a) willingness to attend     screening at the different fee levels (b) screening findings in terms of DR and other eye     diseases (c) risk factors and other characteristics of those screened and unscreened. The     information will allow us to estimate the level of fee which best combines effectiveness with     sustainability in the longer term.   "
32015|NCT02866708|"     This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue     perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot     study will look at the effects of intermittent negative pressure (INP) therapy wound healing     and the peripheral macro- and microcirculation in spinal cord injured patients with chronic     leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized     clinical trial with single-subject multiple baseline design. We will perform convenience     sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment     by the end of december 2016.To ensure equal distribution of participants in each study arm,     we will perform block randomization. A statistician will randomized patients to either     intervention arm or control arm before start of the study: At baseline, each participants     will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP     therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in     the the control group (A) will be re-examined, and start 8-week INP therapy. Also the     intervention (INP) will be subjected to the same lower limb in each individual throughout the     study period. The other leg will act as a intra-individual control.      At baseline (week 0), and during the course of the study (every 4th week), the participants'     wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after     intervention the following measures will be performed: Demographic data (weight, height,     ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser     Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and     health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be     examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx     devices and provided the necessary training to perform this project. Outcome variables     assessed before and after the study period will be: wound healing (primary endpoint), quality     of life (secondary endpoint), skin perfusion pressure (secondary endpoint), ankle-brachial     pressure (secondary endpoint) and segmental pulse-volume recording (secondary endpoint). The     aim of this project is to prospectively examine and elucidate the effect of intermittent     negative pressure therapy applied to a limited part of the lower limb on clinically relevant     measures related to wound healing and peripheral macro- and microcirculation in patients with     spinal cord injury.      The hypotheses of the study are:        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™          device, will improve wound healing in the foot compared to before treatment (baseline)          and compared to standard wound care alone.        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™          device, will improve macro- and microcirculation in the foot compared to before          treatment (baseline) and compared to standard wound care alone in patients with spinal          cord injury.        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™          device, will improve macro- and microcirculation in the intervention foot compared to          the control foot and compared to standard wound care alone in patients with spinal cord          injury.   "
32016|NCT02866695|"     This is a single arm, open-label interventional study of ingenol mebutate 0.015% in solid     organ transplant recipients. The investigators plan to treat 20 subjects, 10 kidney     transplant recipients and 10 lung transplant recipients. The investigators have selected     these two populations as the represent the spectrum of solid organ transplantation: kidney     transplant recipients are the largest transplant population, but have lower levels of     immunosuppression and skin cancer risk. Lung transplant recipients have the highest burden of     skin cancer and actinic keratoses.   "
32017|NCT02866682|"     As the patents for brand-name immunosuppressive medications expire, there is increasing     interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies     showing bioequivalence, questions remain regarding the clinical impact of use of generic     immunosuppression.      The most important immunosuppressive agent in the modern transplant era is arguably     tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to     answer the question regarding the clinical impact of generic tacrolimus use as measured     primarily by acute rejection, loss of graft function, and patient death through a randomized     trial of 4 parallel groups: Brand tacrolimus only, brand tacrolimus for 6 months than switch     to Generic A, Generic A only, or Generic A for 6 months than switch to any other generic     tacrolimus. Given that kidney, liver, and heart transplantation are the most commonly     performed transplants with well-defined measures of rejection and graft failure, these organs     will be studied in a two-center study designed to accrue the target number of transplant     recipients within the three-year study period.   "
32019|NCT02866656|"     In the present study, by evaluating the efficacy and safety of low intensity ultrasonic on     ASO, to explore the noninvasive auxiliary treatment of ASO. 90 patients were randomly divided     into 2 groups: A)control group, patients were given Conventional conservative treatment;     B）treatment group, patients were given Conventional conservative treatment and low intensity     ultrasonic treatment ; Treatments last for 4 weeks, three times a week, stimulation was given     8 minutes every time, location of treatment were lower limb ischemia area and its surrounding     tissues; outcome indicators were recorded Before and 4 weeks after the trial, The Walking     Impairment Questionnaire (WIQ), ankle brachial ratio, the farthest distance Walking,     percutaneous tissue oxygen tension, tissue oxygenation index recovery time, local skin     temperature, ultrasonic blood vessels, and muscle enzymes, hepatic and kidney function.   "
32420|NCT02861391|"     The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in     patients with urinary stress incontinence (USI). Eligible subjects will receive 3 treatment     sessions, 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last     treatment.   "
32020|NCT02866643|"     A barrier to initiating progestin contraceptives in the early postpartum period is the     concern of interference with breastfeeding, specifically lactogenesis. In this trial, the     investigators aim to add to safety data on the effects of immediate insertion of the     contraceptive implant on breastfeeding. The investigators seek to examine the time to     lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a     contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82     consenting women will be randomized to immediate implant insertion (0-2 hours following     delivery) in the delivery room or insertion of the implant following delivery in postpartum     room and prior to medical discharge (24-48 hours following delivery).   "
32036|NCT02866435|"     The purpose of this study is to investigate how the brain responds to low blood glucose in     non-diabetic individuals. The ultimate goal is to understand the brain substrates of     hypoglycemia unawareness, a condition that can occur in patients with type1 diabetes     undergoing insulin treatment.In the present study, the investigators focus on differences     between two groups of non-diabetic subjects: one group who experienced two episodes of     hypoglycemia the day prior to the study (and supposedly developed some level of unawareness     to hypoglycemia), and one group who did not. In this study, a 3 tesla MRI scanner is used to     acquire brain images. The imaging system is identical to the ones used in hospitals.   "
32021|NCT02866630|"     In the last few years, anaesthetics gas such as isoflurane, desflurane and sevoflurane used     in heart surgery have shown some benefits to reduce the risk of heart muscle damage than     total intravenous anesthetics. A study by the investigators suggested that isoflurane needs a     longer duration to achieve equilibrium between coronary sinus and radial artery, indicating     that isoflurane in coronary sinus does not accurately reflect its level in the heart muscle.     Different agents have unique characteristics with different equilibration rate. However, the     levels of sevoflurane and desflurane in coronary sinus and radial artery have not been     measured. In addition, lactate is believed to be a very useful indicator to predict the     outcome of recovery phase after any surgery. This study aims to measure the level of     sevoflurane or desflurane in blood circulation. It will also assess whether sevoflurane or     desflurane concentration in the blood is correlated to the its oxygenator exhaust level and     affected by temperature, haematocrit level and gas flow rate during heart-lung machine. It     also aims to examine the association of lactate and the outcomes of cardiac patient in     intensive care unit after cardiac surgery.   "
32022|NCT02866617|"     In dentistry, 3D printing technology is gaining interest. One of the potential application is     to construct appliances on 3D reconstructed study models.      The purpose of this study is to compare vacuum formed thermoplastic orthodontic retainers     (VFR) constructed on conventional orthodontic study models and reconstructed 3D study models     by assessing the oral health-related quality of life (OHRQoL) instrument, Little's     Irregularity Index (LII) and compliance.   "
32023|NCT02866604|"     The main objective of this study is to compare the clinical outcomes of TBI patients     receiving only Sterofundin or 0.9% saline as main fluid therapy.   "
32024|NCT02866591|"     Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local     cancer breast.      It is sometimes poorly tolerated by some patients who complain of an uncomfortable     examination or pain.      Breast compression by the manipulator aims to reduce the thickness of the breast during     mammography; This act is an important factor of pain or discomfort felt by the patient. But,     it is also an image quality factor.      This study aimed to compare self-breast compression by the patient to the compression     standard technique carried out by the manipulator.   "
32025|NCT02866578|"     Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative     respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly     increase the peri-operative morbidity and require invasive treatments during longer and more     expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related     factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary     atelectasis seems to play a central role in the occurence of these PPCs. The open lung     approach is a ventilation strategy that aims to open the lung and keep it open using     different ventilatory settings. The efficacy of that strategy is not demonstrated in the     global surgical population. However, its application in the perioperative care of cardiac     surgery patients could be of great interest by counteracting the development of atelectasis.      The purpose of this multicentre, double blinded, randomized controlled study is to evaluate     the influence of a perioperative multimodal protective ventilation strategy based on the     open lung approach on postoperative outcomes during the first 7 days following cardiac     surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump     cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end     expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of     ultraprotective ventilation during CPB. It will be compared to a conventional approach     without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary     endpoint is any post-operative pulmonary complication. The secondary endpoints are any     post-operative extra-pulmonary complications and the number of ICU-free days to day 7.   "
32026|NCT02866565|"     Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization     among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and     precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past     decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors,     healing rates of DFU remain low.      Mechanisms of faulty wound healing in diabetic patients are complex, related to both     intrinsic and extrinsic factors. The main reasons for impaired healing appears to be:     1/exhaustion of local cell populations that promote wound healing; 2/excessive production of     matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of     MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor     cells and impairment of their functioning. These imbalances may result in excessive     degradation of extracellular matrix components, as well as an inappropriate local     inflammatory response .      Adipose-derived stroma vascular fraction provides a rich and easily accessible source of     autologous cells for regenerative medicine applications. Il contains multipotent stem cells     and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound     healing. There are attracted to the wound site where they supplement the wound bed with     similar cell types, secrete numerous growth factors and cytokines, increase macrophage     recruitment, enhance granulation tissue, and improve vascularisation . The reparative     capabilities coupled with good safety of ADRCs have been illustrated in a study for treating     severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly     in patients with diffuse scleroderma. Numerous case reports showing healing of refractory     wounds following treatment with autologous ADRCs have also been reported.      Based on these previous reports, the present study aims to assess the efficacy and tolerance     of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.   "
32033|NCT02866474|"     Malnutrition particularly affects people who delegate the preparation of their meals with 46%     of persons living at home and using a meals-on-wheels service, or those in old people's homes     (Etablissement d'Hebergement pour Personnes Agees Dependantes - EHPAD) at risk of     malnutrition, compared with 16% in persons who have help, but not for their meals, and 8% in     independent persons (Aupalesens Survey). This proportion, which is particularly high, is     essentially due to the absence or insufficient level of individual monitoring of the     nutritional status of these dependent populations despite the different recommendations.     EHPAD (old people's homes) are invited to respect meal rhythms, to adapt the nutritional and     gustatory qualities of the food, to propose a pleasant environment (Survey CLCV 2012: data     collection in 2012); in parallel, few professionals are really trained in the needs of the     elderly. In meals-on-wheels services, apart from the distribution of meals, no nutritional     follow-up is proposed (Guide 2012).      Symmetrically, the constant search to control costs in western healthcare systems has led     managers to systematically reduce care costs, in particular those that are not directly     related to medico-pharmaceutical or care personnel expenditure in the strictest sense. In the     collective catering services, there is, for example, a systematic effort to reduce daily     costs/materials, without measuring the global cost related to the efficacy of care.      The present work is part of the RENESSENS project: these studies will be conducted in two     elderly populations, one living at home and receiving meals on wheels daily and a regular     visit of a dietician, who will propose individual nutritional follow-up and the second living     in an old people's home (EHPAD) that will benefit from the improved management of its     catering service (good culinary practices, including specific training for personnel and     meals adapted to the needs of residents). The principal aim of these two studies will be     common and will be to evaluate the efficacy of this specific type of management of meals and     nutrition compared with a reference meals-on-wheels service and a reference EHPAD.   "
32027|NCT02866552|"     Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an     alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are     frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a     result, patients suffer from everyday disability, with consequences on their occupational     activities and social contact, sometimes severely altering their quality of life. To date, no     anti-fibrosis treatment has proven effective; existing vasodilation treatments are     unfortunately not very effective, and are associated with adverse effects or restrictions. It     is consequently of utmost importance that an effective treatment for sclerodermic hands be     developed. The injection of adipose autologous tissue is a common practice in plastic     surgery, and has been known for over a century. Adipose tissue, originally used to increase     volume, is also characterized by trophic properties associated to stromal vascular fraction     (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some     SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc.     The injection of SVF into the fingers would also make it possible to control the production     of the extracellular matrix and to improve the balance between fibrosis and fibrolysis,     resulting in an improvement of cutaneous sclerosis      The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients     suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison     to the control group.   "
32028|NCT02866539|"     The aim of the study is to control blood sugar with Sugar Balance capsules which is the     leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea     spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.   "
32029|NCT02866526|"     Severe haemophilia is a rare disease characterized by spontaneous bleedings from early     childhood, which may lead to various complications especially in joints. Due to advances in     medical care and more specifically in the development of prophylactic strategies by the     application of clotting factor concentrates, life expectancy of persons with severe     haemophilia has significantly increased over the last decades. This progress requires a     long-term follow-up, including into adulthood. The adherence to a regular clinical follow-up     and to a prophylactic treatment then depends on how successful patients' transition from     childhood to adulthood has been as this process involves a transfer of responsibility from     parents to patients concerning the management of their health. Beyond the issue of patients'     adherence, a suboptimal transition may also impair quality of life and the entry into     adulthood, especially at the social, emotional and professional levels. Only a few studies     have been conducted to identify the specific needs and difficulties young persons with severe     haemophilia experience during their transition from childhood to adulthood, and none of these     studies has been carried out in France where the features of the health care system are very     specific.      Therefore, this study aims to address the issue of transition into adulthood among young     persons with severe haemophilia in France. This study will focus not only on the facilitators     and barriers of the access to health care but also, from a more global perspective, on all     the specific concerns and difficulties they may experience as they grow into adulthood which     may impair their long-term health related quality of life as well as their personal     empowerment. This study will also allow to identify some of the socio- cognitive, emotional,     and familial determinants of a good transition into adulthood.   "
32030|NCT02866513|"     Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury     (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI     during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like     APRV could generate high levels of transpulmonary pressure.      The aim of this study is to evaluate the variations of transpulmonary pressure during the use     of APRV by clinicians   "
32031|NCT02866500|"     Context: the oral cancer is the 5th cancer in order of frequency for human in France. It is     the country where the mortality by oral cancer is the most raised in Europe. The most     frequent location concerns the oral cavity prevalency of which is one of higher in the world.     The main risk factors are the tobacco and the alcohol.      The oral cancer is treated in the great majority of the cases by radiotherapy which is going     to pull xerostomy, responsible for the degradation of the oral state. Furthermore, it will     increase the risk of appearance of osteoradionecrosis (ORN) when the patient is carrier of     buccal lesions and\or when he will have to undergo surgical acts. Consequently, the initial     oral state of the patients is to be estimated so as to eliminate any source of the infection.     An unfavourable initial state will increase the risk of degradation of this one and     appearance of ORN. However, at present few epidemiological data are available concerning the     oral state of the patients presenting an oral cancer.      Objective: the main objective of this study is to describe, before radiotherapy, the oral     state of the patients presenting an oral cancer and to follow the evolution of this oral     state for three years and to register the patients quality of life. The secondary objectives     are to describe the distribution of risk factors of the degradation of the oral state (oral     hygiene, food habits, xerostomy, consumption of tobacco and alcohol) in this population and     to register the impact of the dental restorations on the radiological assessment.      Methods: this prospective epidemiological study of observation will be realized in the     service of odontology of the Timone hospital (Marseille, France) in association with the     services of ORL and maxillofacial surgery of Timone as well as the services of radiotherapy     and medical oncology of Timone and Paoli Calmettes institute (IPC). All the toothed patients     affected by an oral cancer untreated will be included, or treated surgically only, of more     than 18 years old and for whom an initial dental assessment will be realized. The main     assessment criteria will be the CAD index and the parodontal state.      Expected results and perspectives: This study will allow to have epidemiological data     concerning patients' oral state affected by an oral cancer before and after radiotherapy. It     will allow to set up a consensus of good practice.   "
32050|NCT02866253|"     The purpose of this study is to compare the effect of pre-IVF cycles treatment with and     without DHEA(Dehydroepiandrosterone) on the ovarian reserve markers, the number of oocytes     obtained and IVF(in vitro fertilization) outcomes of DOR(diminished ovarian reserve) patients     and the expression of BMP-15(bone morphogenetic protein 15),GDF-9（growth differentiation     factor 9) and IGF-I(insulin-like growth factors-1) in follicular fluid.   "
32457|NCT02860910|"     The general objective of this study is to advance insight into non-pharmacological treatments     for maturing women that impact psychological health and wellbeing of women adapting to     menopause, a natural but often challenging developmental milestone.   "
39224|NCT02772224|"     Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of     below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty     (BA).   "
32032|NCT02866487|"     The pattern of lower airway inflammation in asthma is heterogeneous, but in many patients,     the polymorphonuclear neutrophil (PMN) is the predominant granulocyte infiltrating the     airspaces. Although it is known to have an important function in innate immune defense, the     role of the PMN in asthma has not been well elucidated. In work in progress, the     investigators have identified the receptor for IL-5 on the surface of bronchoalveolar lavage     (BAL) PMNs in a subset of children with severe, treatment-resistant asthma, a characteristic     that is not found in peripheral blood neutrophils. While the function of this IL-5 receptor     has yet to be determined, preliminary evidence strongly supports a mechanism linking     neutrophilic with type 2 inflammation in the lower airways of children with asthma, a     discovery that has exciting potential to modify the treatment of asthma.      The primary objective of this observational cross-sectional study is to test the overall     hypothesis that therapeutic intervention directed against the IL-5R on lung PMNs will     decrease inflammation and improve clinical outcomes in patients with poorly controlled     asthma. The secondary study objective is to demonstrate that IL-5R expression on     lung-infiltrating PMNs is functional, will activate known IL-5R-induced signaling pathways,     and will lead to enhanced PMN pro-inflammatory activity including increased PMN recruitment,     prolonged survival, degranulation, and release of reactive oxygen species.   "
32034|NCT02866461|"     This study is designed to study brain mechanisms associated with symptoms and severity of     Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported     and objective measures of disease severity.   "
32035|NCT02866448|"     The purpose of this study is to investigate the effect of acute isoquercetin supplementation,     aspirin, and isoquercetin/aspirin combination on platelet aggregation, blood pressure and     vasculat stiffness (eg digital volume pulse), as well as investigating the plasma     accumulation and urine excretion profiles of quercetin.   "
40293|NCT02758210|"     The purpose of this study is to evaluate the effects of Electromagnetic field exposure using     a Tablet on MICRA device (leadless pacemaker) as well as study the effects of Electromagnetic     field exposure using a smart phone on MICRA device.   "
32039|NCT02866396|"     Spinal surgery is associated with intense pain and associated to a history of preoperative     chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when     high dose of opioid are required. Preoperative pain is associated with high postoperative     pain scores and opioid requirement promoting persistent hyperalgesic state. The investigators     will evaluate the postoperative opioid consumption and pain scores in patients scheduled for     lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative     pregabalin-free patient that will receive pregabalin only during surgery.   "
32040|NCT02866383|"     This is a prospective, randomized, open-label phase 2 study in patients with metastatic PC     refractory or intolerant to at least one line of prior systemic chemotherapy with gemcitabine     or platinum-containing regimens to determine the efficacy and safety of nivolumab or     nivolumab plus ipilimumab administered concurrently with high dose RT. Patients with     metastatic PC who are feasible candidates for radiation and biopsy of primary and/or     metastatic lesions will be included.   "
32041|NCT02866370|"     The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30     with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and     Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis     must be histologically confirmed and central pathological review of the presenting tumour or     biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous     differentiation   "
32042|NCT02866357|"     To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute     exacerbation of COPD and asthma who required hospitalization.      To identify the HRV subtypes that are associated with COPD and asthmaexacerbations.      To assess if the infective aetiologies have associations with the clinical outcome of the     patients.   "
32043|NCT02866344|"     This single-center, prospective, randomized clinical trial is designed to compare the     clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to     determine the optimal operative intervention for the local treatment of resectable colorectal     cancer liver metastases. The primary aim of this study is to test the following hypothesis:     2-year local disease control is equivalent between patients receiving the experimental     therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment     for colorectal cancer liver metastases determined to be resectable by radiographic imaging.     Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic     disease recurrence rates are equivalent between the two treatment arms in this study.   "
32044|NCT02866331|"     This study is performed to reveal the safety and feasibility of combination therapy with     autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of     G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1)     Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test     (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic     factors/anti-inflammatory cytokines.   "
32045|NCT02866318|"     This retrospective, cross-sectional cohort study was conducted to investigate the novice     practitioners' learning curve of visual estimation of LV ejection fraction (%) through a     echocardiographic video files at the academic emergency department (ED) in tertiary urban     hospital.   "
32046|NCT02866305|"     Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous     pneumothorax in young adults is very limited, and treatment has also been controversial.The     Aim of this study is to optimize the treatment, estimate the actual incidence, and identify     possible risk factors including genetic predispositions.   "
32047|NCT02866292|"     This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and     non-pregnant nulliparous women and to correlate with their sexual function and b) to compare     PFM strength and sexual function between women in the second and third pregnancy trimesters.   "
32048|NCT02866279|"     The investigators goal is to measure the impact of timing of postpartum contraceptive implant     insertion on breastfeeding success and duration and to explore women's experiences with and     attitudes towards contraceptive and breastfeeding counseling in the peripartum time period   "
32051|NCT02866240|"     This is a single site, non-randomized, prospective, open-label, interventional     pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical     epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure     onsets originating from the lateral cortical surface of any lobe. Patients will be recruited     from the epilepsy clinics of Boston Children's Hospital (BCH) and Beth Israel Deaconess     Medical Center (BIDMC), the home institutions of the principal investigators. All patients     and referring physicians will be requested to maintain their current antiepileptic drugs     throughout the study with changes after enrollment permitted only to maintain pre-enrollment     drug levels, or if clinically necessary. The primary outcome measure will be the change in     seizure frequency (seizures/4-week period) as compared to baseline. Secondary outcome     measures include change in interictal discharge burden, change in cortical excitability, and     quality of life measures.      Patients with medically-refractory neocortical epilepsy will receive cathodal tDCS     administered to the seizure focus for 10 sessions over a 2-week period with the allowance of     make-up sessions in week three. Subjects will be evaluated at baseline, during the     stimulation sessions, and 4 and 8 weeks after the completion of the tDCS visits   "
32052|NCT02866227|"     This is a Phase II study designed to assess the safety and efficacy of an investigational     product, TOL-463, to treat vaginitis.   "
32053|NCT02866214|"     The Purpose of this study is to determine if the Febuxostat has an effect on endothelial     dysfunction on hemodialysis patients.   "
32054|NCT02866201|"     Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported     based on studies in 20 to 60% of travelers, depending among other conditions and travel     destinations. Currently, less than 30% of the etiology of diarrhoea is identified by     bacteriological v,irological and parasitology traditional techniques. This ignorance of the     diarrhoea etiology causes difficulties in the establishment of a specific and rapid     management in this extremely common condition and having a significant cost to society.     Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase     Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's     diarrhoea using simple rectal swabs.      So, the principal objective of this study is to assess the efficacy of a new diagnosis     strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The     hypothesis consists in improving the number of patients with a confirmed etiological     diagnosis of traveler's diarrhoea by 5%.   "
32055|NCT02866188|"     In this study, we want to find out whether the recognition of cardiac arrest using a smart     watch is feasible or not. If this idea is possible, the recognition of cardiac arrest using     the smart watch is easy and fast to the witness, like a general person. By using the smart     watch, the emergency response system for cardiac arrest and the bystander CPR or BLS is     beginning earlier than using conventional cardiac arrest recognition method in field.   "
32056|NCT02866175|"     There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy     in subjects with atrial fibrillation AF following percutaneous intervention PCI with     stenting. This study is designed to evaluate the safety and to explore the efficacy of an     edoxaban-based antithrombotic regimen versus a vitamin K antagonist VKA-based antithrombotic     regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety     outcome in cardiovascular clinical trials, especially for antithrombotic strategies and     invasive procedures.   "
32057|NCT02866162|"     Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases     characterized by congenital neutropenia associated with the involvement of other organs. Most     patients have syndromic congenital neutropenia, which does not correspond, either clinically     or genetically, to any other previously described form. A large number of genes still have to     be identified in these syndromic forms.      The aim of this study is to identify the molecular bases of congenital neutropenias that have     not yet been classified, by taking advantage of high-throughput exome sequencing.   "
32058|NCT02866149|"     Exploratory study on blood-borne biological markers and their correlation with clinical and     pathological characteristics.   "
32059|NCT02866136|"     Conservative treatments of retinoblastoma (RETINO 2011)        1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction          (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8        2. -Multicentric non randomised, phase II study for the patients with bilateral very          asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups          B/C/D according to the age and vitreous seeding        3. - Multicentric non randomised, phase II study for the patients treated by 6 cycles of          three drugs regimen and local treatments for bilateral group D eyes or on the only eye.   "
32060|NCT02866123|"     There are several ways to verify the correct positioning of a gastric tube. Radiography is     considered the reference method. The use of ultrasonography could diminish the number of     radiographies necessary. The hypothesis of this research is that gastric ultrasonography     performed during insertion of the tube is a reliable examination to check the correct     positioning of gastric tubes in intensive care.   "
32061|NCT02866110|"     Emotion-related brain activation is made visible for patients via neurofeedback with the aim     to improve discriminability of emotional arousal and emotion regulation. With functional     magnetic resonance imaging (fMRI), information of current brain activation is imaged and fed     back to the patient via a visual display. Patients with borderline personality disorder (BPD)     usually hyper-activate brain regions associated with emotion. In this study, BPD patients     will be provided with neurofeedback from the amygdala, which is crucial for the processing of     emotions. The aim of the study is to observe, whether amygdala-neurofeedback would help BPD     patients to improve emotion regulation. Compared to a control condition, improved brain     self-regulation and emotion regulation is expected with three neurofeedback training     sessions.   "
32062|NCT02866097|"     This study will provide important evidence to the Ministry of Community Development, Mother     and Child Health (MCDMCH) and the Ministry of Health (MOH) on how to effectively implement     iCCM with a focus on improving both the flow of supplies to CHWs as well as the quality of     their supervision and mentorship. The overall aim will be to determine whether improvements     in supplies for community health workers (CHWs) and strengthened supervision result in     improved early and appropriate treatment for children with malaria, pneumonia, and diarrhea     in rural Zambia when compared to CHWs offering iCCM without this logistics and supervision     support.   "
32077|NCT02865902|"     Objective: The aim of this study was to determine the effects of Low Level Laser Therapy     (LLLT) on wound healing at Free Gingival Graft donor sites (FGGDS).      Materials and Methods: Forty patients requiring FGG were selected for this randomized     controlled double blinded prospective clinical trial. The FGGDS were treated with LLLT and     compared with an untreated control group. The Wound Healing Index (WHI), tissue consistency,     colour match (CM), and H2O2 bubbling test for the evaluation of complete wound     epithelialization (CWE) were recorded at the 3rd, 7th, 14th and 21st days. The pain-burning     level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue     thickness (TT) was measured at baseline and at the 1st month.   "
32097|NCT02865642|"     In this study the investigators want to test the hypotheses that, serotonergic     neuromodulation increases perilesional neuroplasticity, leading to improved behavioural     outcomes through a more efficient allocation of functional resources, greater structural     reorganization and less remapping via alternative circuits.   "
32066|NCT02866045|"     Sub epithelial lesions (SELs) of the gastrointestinal (GI) tract are commonly identified     during routine endoscopy. Most of these lesions are benign. However because there is the     potential for malignant transformation it is important to correctly identify the lesion in     order to determine if any further therapy and/or surveillance is necessary for the patient,     particularly for gastrointestinal stromal tumors (GISTs).      Obtaining a definitive diagnosis for SELs is often difficult since biopsies of the normal     overlying surface mucosal layer are typically normal. EUS-FNA is the standard method by which     a biopsy-proven diagnosis is obtained for most SEL's. However, the yield for a definite     diagnosis from EUS-FNA for SELs is often suboptimal. Recently a new biopsy method, called     single incision needle-knife (SINK) was introduced that may prove more useful in     determining a definitive diagnosis. Furthermore, recent advances in core biopsy needles for     EUS offer the hope for improved outcomes with EUS-guided fine-needle biopsy (FNB). However,     it remains unclear whether superior diagnostic outcomes are obtained using the new SINK     biopsy method or using new EUS-FNB core needles.   "
32067|NCT02866032|"     The primary objective of this study is to evaluate the efficacy of topical MOB015B in     patients with mild to moderate distal subungual onychomycosis (DSO).      The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to     moderate DSO.   "
32068|NCT02866019|"     The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial     regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal     wound site after extensive ESD for superficial esophageal cancer.   "
32069|NCT02866006|"     BVAC-C is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell.     This study is Open-label, dose-escalation, multiple dosing study to evaluate the safety,     tolerability, immune response and pre efficacy of BVAC-C in patients with multiple metastatic     progressive or recurrent HPV type 16 or 18 positive cervical cancer after failure to standard     care. 9~18 patients will be enrolled   "
32070|NCT02865993|"     The purpose of this study was to evaluate, for the first time in Literature, the effects of     betadine washing versus normal saline washing after uterine closure in women undergoing     cesarean section (CS) at ≥36 gestational weeks in terms of post CS infections, complication,     fever and pain.   "
32071|NCT02865980|"     This randomized clinical trial will conducted involving 60 patients under hemodialysis and     hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were     assigned to experimental and control groups of 30 people, randomly (double block). In the     both intervention and control group, first will be washed the Catheter with Betadine, but in     intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for     15 seconds. The incidence and severity of inflammation as well as infection of vascular     access will be assessed in patients on hemodialysis for each patient before starting the     process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.   "
32072|NCT02865967|"     Asthma is the most common chronic condition in children and one of the five most burdensome     diseases in the United States. Despite this, research and care for childhood asthma are     limited by inefficient utilization of electronic medical records (EMRs) to facilitate     large-scale studies and care.      The primary goal of this clinical trial is to implement the asthma-Guidance and Prediction     System (a-GPS) on the Asthma Management Program (AMP, a current care coordination program for     asthma care of children aged 5-17 years at Mayo Clinic). Primary hypothesis: The     implementation of a-GPS in the current care is logistically feasible.   "
32073|NCT02865954|"     he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is     associated with incontinence, pain, reduced stability of the core and functional deficits.     The Society of Obstetricians and Gynaecologists of Canada recommends instruction on the     correct performance of pelvic floor muscle exercises, commonly known as Kegels, as standard     care. However, only a small proportion of women seek medical care for incontinence in Canada.     Recently, there has been an influx of mobile Health technology applications marketed for     pelvic floor restoration and fitness that have not been studied. The existence of mHealth     technologies may represent an innovative mode to support pelvic health, however systematic     exploration to substantiate claims and proposed benefit is required. This pilot study aims to     understand the utility of a new mobile health application, iball, as a rehabilitation tool to     promote optimal pelvic floor function and to correct pregnancy related pelvic floor     dysfunction. The iball is comprised of a device and a mobile app, and it has been brought to     market in Europe as a consumer product. The study aims to assess the acceptability,     feasibility, and effectiveness of the iball as a pelvic floor muscle training intervention,     in comparison to standard care.   "
32107|NCT02865512|"     It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore,     intraoperative or postoperative pain management using continuous thoracic epidural     catheterization is suggested good option to prevent this complication.      The spread of local anesthetics is influenced by various factors including volume, location     of needle insertion, speed of injection, patient position, age, weight and height. However,     there are few studies about the effect of different patient position during thoracic epidural     catheterization.      This study was designed to evaluate the effect of different patient position affecting     thoracic epidurography.   "
39581|NCT02767544|"     In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine (     vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative pain     and need of oxycodone.   "
32074|NCT02865941|"     It has been observed that target fortification on different schedules leads to meal to meal     variation. It changes the ratio of protein to energy and the percentage of carbohydrate to     non-protein energy which may, affect growth. In the past, the investigators have analyzed the     outcomes of breast milk composition when target fortification is done with different analysis     schedules. The investigators were able to measure the macronutrient intake for different milk     analysis schedules via a theoretical model and show that the more frequent schedules reduce     the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation     of macronutrients. It was observed that, in all the breast milk samples measured twice per     week, infants achieved on average the recommended macronutrients in line with current     recommendations. Nonetheless, the model only looks at the macronutrient intake and does not     investigates the relationship between macronutrient variation and its effect on growth.      The aim of the current study is to compare a frequent schedule of measurement of     macronutrient analysis with a reduced schedule of measurement and to study its affect on     growth, protein accretion and metabolic parameter.   "
32075|NCT02865928|"     This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in     subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will     be enrolled into the study at presurgical testing. Subjects will be stratified based on     surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or     placebo. All patients will receive standard intraoperative anesthesia and standard     postoperative pain control. The primary endpoint is the amount of opioid administered     postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals,     amount of opioid administered intraoperatively and postoperatively, incidence of nausea and     vomiting, time to discharge and patient satisfaction   "
32078|NCT02865889|"     Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for     colorectal and gynecologic cancers. This innovation could be used either for staging purpose     and therefore could steer global therapeutic options or for surgical management only.      Increase knowledge and skills lead to an increase in the number and rate of the women this     innovation could be offered. The project team observed a shift from traditional surgical     management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.      This innovation however increases some costs (the surgical stage) but decrease some others     (the post surgical stage).      Foreseeing the pace of the dissemination needs to have objective and reliable data about who     had access to laparoscopic surgery and who didn't (and why) and accurate assessment of     related costs.      This program will focus on uterine cancer (both cervix and corpus).   "
32079|NCT02865876|"     The objective of this study is to evaluate the efficacy and safety of accelerated     cross-linking (Avedro Inc., Waltham, USA) in the management of microbial keratitis as     adjunctive therapy.   "
32080|NCT02865863|"     A phase II randomized, placebo controlled study evaluating the efficacy of     Eurycomalongifoliawater extract (Physta®)+Multivitamin on quality of life and mood on 86     healthy adults over a 24 week supplementation period.   "
32081|NCT02865850|"     A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of     anemia and maintenance of HGB in subjects with DD-CKD.   "
32082|NCT02865837|"     The purpose of this study is to compare, for each patient, dosimetry of organs at risk     (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a     urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical     cancer.   "
32083|NCT02865824|"     Current guidelines recommend discontinuation of antiplatelets (i.e clopidogrel) for 7 days in     patients taking DAT (dual antiplatelet therapy) before colonoscopy and polypectomy. The     purpose of this study was to examine if a) discontinuation of these drugs reduces bleeding     risks during polypectomy and if b) discontinuation of these drugs increases the occurence of     thromboembolic events.   "
32084|NCT02865811|"     This research study is studying the combination of Pegylated Liposomal Doxorubicin (PLD) and     Pembrolizumab as a possible treatment for Recurrent Ovarian, Fallopian Tube or Peritoneal     Cancer that is resistant to platinum therapy.      The following interventions will be used in this study:        -  Pegylated liposomal doxorubicin (PLD)        -  Pembrolizumab   "
32085|NCT02865798|"     Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after     coronary artery disease, hypertension, and heart failure, especially in senile patients who     have more comorbidities and often require intervention. The prevalence of senile VHD is     increased gradually as the growth of the age. In addition important changes have occurred as     regards the presentation and treatment of the disease over recent years. However, there is     little information about senile VHD in China. The purposes of this study are to evaluate the     clinical characteristics, reasons for hospitalization, risk stratification, treatment     modalities, quality of life and outcomes of senile hospitalized patients with VHD, to     determine the risk factors affecting the prognosis, further to lay the foundation for     establishing a prognosis model suitable for Chinese senile VHD.   "
32086|NCT02865785|"     The aim of present study is to evaluate the effect of intralipid 20% infusion, once between     days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test     on clinical pregnancy rates in women with unexplained recurrent implantation failure.   "
32087|NCT02865772|"     The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy     term newborns.   "
32088|NCT02865759|"     To improve pregnancy outcome, 39 000 pregnant women will be randomized to receive information     about Mindfetalness or to routine care. The level of randomization will be the antenatal     clinics in the Stockholm area.   "
32089|NCT02865746|"     The objective of this randomized double-blind study was to evaluate the effect of     betamethasone in the control of postoperative pain in patients undergoing endodontic     treatment.   "
32090|NCT02865733|"     The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil     Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH)     after Fontan operation with univentricular physiology.   "
32091|NCT02865720|"     The purpose of this study is to determine if an investigational treatment is safe and well     tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.   "
32092|NCT02865707|"     Ulcerative colitis (UC) is a relapsing chronic intestinal inflammation with no existing cure,     that affects over 300 per 100.000 Canadians, the highest prevalence in the world. The     standard drug therapies are expensive and potentially toxic, and mostly directed against the     chronic inflammatory process. UC is the result of a dysbiosis between disease-inducing and     protective intestinal bacteria in a genetically susceptible host. Non-digestible dietary     carbohydrates (NDC) stimulate the growth of protective endogenous intestinal bacteria which     ferment them into short-chain fatty acids (SCFA), some of the latter with natural     anti-inflammatory properties, and are called prebiotics. The investigator was the first to     report that oral intake of NDC, the dietary β-fructans inulin plus fructo-oligosaccharides     (FOS), reduced colitis in a genetically-induced rat colitis model. Both inulin and FOS     reduced colitis, each NDC modifying specific luminal microbiota. A small trial with the same     mixture of NDC in patients with active UC relapsing on oral 5-aminosalicylic acid (5-ASA)     showed a dose-dependent clinical response, confirming the translational potential of this NDC     mixture.      The investigators propose a randomized placebo-controlled trial to assess if inulin plus FOS     can also prevent such relapses in UC patients with inactive disease on stable maintenance     drugs. Primary hypothesis is that inulin plus FOS is effective adjunct therapy to standard     drugs for maintaining clinical remission. The second hypothesis is that the colonic     microflora and its metabolic function, altered by inulin plus FOS, or not, mediate protection     or relapse in UC. The longitudinal design of this maintenance prevention study and by     serially collecting colon biopsies, stool, serum and urine within the same patient before a     relapse (inflammation) occurs, would enable to identify unique changes in the intestinal     microbiota, their metabolic functions and also assess effects on host-immune response that     are associated with remission or before a relapse occurs during treatment with beta-fructans,     or not.   "
32093|NCT02865694|"     Familial hypercholesterolemia (FH) is a most prevalent genetic disorder define as high     cholesterol level and premature death. The prevalence of FH reported in few countries however     unknown in Iran. Thus determine the FH patient, finding diagnostic strategy and appropriate     treatment are important. We intent to use cascade method to screening patients, also our     expected outputs are to develop and implement a registry program for FH patients and their     families and to study their genetic disorder. FH patients will be followed from management,     treatment and prevention of Cardio vascular disease in order to increase premature death.   "
32099|NCT02865616|"     MET-2 clinical study is an Open label, single center, multiple dose pilot study of 20     patients. The study is designed to measure the resolution of diarrhea as well as the     feasibility of administration and safety of MET-2 for the treatment of recurrent CDI in     patients who have experienced at least two prior episodes of CDI and have developed     recurrence after having completed standard-of care oral antibiotic therapy to treat CDI.   "
32100|NCT02865603|"     The aim of this study is to measure the impact of the intervention (PAX GBG) during 7 months     in Estonian-language 1st grade classrooms on students' mental health and behaviour, and     teacher's self-efficacy.   "
32101|NCT02865590|"     The sinus infiltration technique for sinus floor elevation has been used successfully when a     reduced vertical height is available in the posterior maxilla. However, the effect of the     different graft material on the volume and on the quality of new bone formed has not been     fully investigated. The aim of this study is to evaluate the clinical and histological effect     of a test material, lyophilized equine bone (Bio-gen®), compared with control material,     deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.   "
32102|NCT02865577|"     Poor function of the right side of the heart and rise in pressure of the blood vessels     leading to the lungs are two main heart-related factors that are associated with worsening of     airway disease. A relatively new method which uses magnetic field to create images of the     heart called cardiac magnetic resonance (CMR) imaging shows immense promise in detailed and     accurate assessment of the heart in patients with airway diseases. This project aims to     assess the heart in patients with asthma and chronic obstructive pulmonary disease (COPD) as     well as healthy participants using CMR to help us determine features on CMR that are     different is patients with asthma and COPD compared to healthy participants. This may help     with early identification of patients who are at risk of episodes of acute worsening of     airway disease, called exacerbation, and potentially halt the progression of the heart     dysfunction with currently available or new treatments.      Study involves one visit at Glenfiled Hospital, Leicester, lasting approximately 4 hours. The     visit will include following assessments: clinical history, health status, physical     examination, electrocardiogram (ECG), blood tests, lung function testing, echocardiogram and     CMR. Part of the study will involve a participant questionnaire in which the participants     will rate their CMR experience. The results will potentially change the way CMR is     undertaken. A sub-set of the participants will also be invited back to do a one off focus     group discussing the CMR experience further.   "
32103|NCT02865564|"     The aim of the study is to elucidate the relationship between postnatal antibiotic     administration on development of gut microbiota and possible protective influence of     simultaneously administration of probiotic during antibiotic therapy on development of gut     microbiota, functional gastrointestinal disorders of infancy, weight gain and body     composition.   "
32104|NCT02865551|"     The investigators intend to compare the rate of urinary retention among female patients after     vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either     by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization     applied every 4 hours during labor.   "
32105|NCT02865538|"     This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose     study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will     be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be     dosed for 14 days.   "
32106|NCT02865525|"     Medication non-adherence is an economic problem and a major public health challenge. Factors     influencing medication adherence can be modelled according to five dimensions: disease,     medication, patient and its close relatives, demographic and socioeconomic factors and health     care system. A tool is needed to qualify medication adherence in order to adapt tailored     support for individual patients to promote and optimize adherence to therapy.      The objective of this work is to present the preliminary results of QUILAM project which is     divided into 3 phases: 1. Development of a tool to assess barriers to medication adherence in     chronic patient (COPD, Heart failure, Type 2 diabetes) ; 2. Validation of the instrument     (especially against clinical criteria) ; 3. Evaluation of the sensitivity of the tool during     educational interventions.   "
32458|NCT02860897|"     PURPOSE: To evaluate patient adherence to cream versus tablet based local estrogen therapy by     randomizing treatment modalities to determine differences in adherence to either form.      HYPOTHESIS: There is no difference in adherence to cream versus tablet based local estrogen     therapy when prescribed as a 6 week course of postoperative therapy after female pelvic     reconstructive surgery.   "
32108|NCT02865499|"     This study addresses a lifespan approach to healthy development and aging with direct     relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot     study to: i) better estimate power for a larger trial, ii) establish the safety and potential     beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the     effects of acarbose on the microbiome likely play a role in its enhancement of longevity     and/or healthy aging. These are essential initial steps for translating acarbose into an     anti-aging human therapy.   "
32109|NCT02865486|"     In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions     will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that     they differ in terms of acid stability, lipid droplet size and fat redispersibility. The     investigators hypothesize that the gastric emptying of fat will differ between the lipid     emulsions.      An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid     emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded     study.   "
32184|NCT02864498|"     The purpose of this study is to determine whether orally administered DS107 (1g and 2g doses)     is effective in the treatment of moderate to severe atopic dermatitis.      Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.      The study will enroll approximately 300 subjects.   "
34754|NCT02830867|"     The glutathione synthetase deficiency, inborn error of metabolism of autosomal recessive     inheritance, is a rare disease (70 patients described in the world). The outcome of these     patients and potential complications of this disease are not, to date, yet all known and     described.   "
32110|NCT02865473|"     The aim of the present study is to develop a measurement protocol for optimal imaging of the     anterior segment of the eye, including anterior chamber angle, Schlemm's canal, filtering     bleb and pseudoexfoliation deposits on the lens based on measurements in patients with     glaucoma and PEX. In glaucoma the structures of the anterior chamber are important for     classification, therapy, progression and prognosis and imaging of the angle between the iris     and the cornea is the key for open angle and closed angle glaucoma differential diagnosis.     For this purpose, a customized ultrahigh resolution Spectral Domain OCT will be used to     validate whether the protocol can also be more widely applied in these patients. Based on the     obtained measurement protocol, further studies investigating anatomy and pathophysiology of     the anterior segment of the eye as well as surgical outcome in patients with glaucoma and PEX     can be planned.      The aim of the study is to develop a measurement protocol for OCT imaging and     characterization of the anterior chamber in glaucoma patients.   "
32111|NCT02865460|"     The primary objective of this clinical trial is to determine if treatment with ubiquinol, a     form of coenzyme Q10, improves the physical function of men and women Veterans suffering from     Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short     Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms.     Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers     in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity     level, and cognitive and mental functioning.   "
32112|NCT02865447|"     Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral     bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used     as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip     joint.   "
32113|NCT02865434|"     Prospective, open-label, multicenter, dose escalation, safety study of injected Tc 99m     tilmanocept in the detection of and assessment of localization to skeletal joints in subjects     with and without active RA by SPECT imaging.   "
32114|NCT02865421|"     Androgenetic alopecia (AGA) is a common form of hair loss in both men and women,     characterized by progressive patterned loss of hair from the scalp. The current study has     been designed for restoration of hair in AGA by implanting a combination of autologous     mesenchymal stem cells (derived from the adipose tissue) and human platelet rich plasma.   "
32115|NCT02865408|"     Enhancing the anabolic effect of nutrition in critically ill patients by administering     exogenous amino acids.   "
32116|NCT02865395|"     Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a     variety of ailments. These procedures often require that the bladder be filled and emptied     with sterile water or saline several times during the procedure, and often result in the     patient receiving a catheter at the end of the procedure. One common side effect is that     patients experience bladder spasm or discomfort for a period of time after these procedures.     Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the     post-operative setting to relieve these symptoms.      The principle objectives of this study are:        1. To determine if the addition of a B and O supprette suppository at the end of          cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and urinary          discomfort that patients experience in the post-operative setting.        2. To determine if using peri-operative B and O supprette suppositories reduces the need          for pos-operative oral Ditropan and use of narcotic pain medications.   "
32117|NCT02865382|"     Optical Enhancement Technology might be superior to the conventional HD-WL in detecting     colorectal adenomas   "
32118|NCT02865369|"     A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir     and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic     hepatitis C genotype 1b Infection   "
32119|NCT02865356|"     The study is designed as a proof of concept, multi-center, randomized, double-blind and     vehicle-controlled study with intra-individual comparison of treatments.      Three age cohorts of patients will be included in the study according to the following age     ranges:        1. ≥18 years old (minimum 6, maximum 18 patients)        2. >12 - 17 years old (minimum 6, maximum 18 patients)        3. >2 - 12 years old (minimum 6, maximum 18 patients)      The main objectives of study are:      To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A [CsA]) compared to     placebo topical solution for the treatment of patients with mild to moderate atopic     dermatitis (AD).      To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients     with mild to moderate AD.   "
32459|NCT02860884|"     The main objective of this study is to evaluate the ability of infrared spectroscopy to     discriminate simple hepatic steatosis from NASH   "
32120|NCT02865343|"     The investigators have an existing exercise program (N>70) with a unique population of     individuals with spinal cord injury (SCI) who have been enrolled in FES-RT for at least 6     months. Roughly half have high level SCI. Thirty individuals with high level SCI who have     FES-row trained for at least 6 months will be randomized to (continued) FES-RT for 4 months     with either NIV or sham NIV. Before and after training, the investigators will assess maximal     aerobic capacity, ventilation, cardiac output, and arterio-venous oxygen difference. Based on     the investigators current data, it is hypothesized that only those randomized to NIV will     experience further increases in aerobic capacity and that these increases will relate to     increases in cardiac output and arterio-venous oxygen difference. This     Exploratory/Developmental Research project will lay the groundwork for a larger study of the     impact of FES-RT+NIV to improve health and function in those with high level SCI.   "
32121|NCT02865330|"     Description:      Multicentre observational study, not randomized. Ambispective character (retro and     prospective). Opened to any member of the Asociación Española de Urología (AEU), public and     private medicine.      Justification:      Active surveillance is a strategy proposed to control the overtreatment derived from the     opportunist screening in prostate cancer (PCa).      Its development in our country is erratic and different in every Center. This database tries     to include most of patients included in active surveillance in Spain with a few minimal     inclusion criteria.      Multicentre registry and follow up of the active surveillance in Spain.      Hypothesis:      Mortality cancer specific for PCa includible in active surveillance to 15 years is lower than     5 %.   "
32122|NCT02865317|"     Cortical activity during rest and with stimulation by functional magnetic resonance imaging     will be investigated in patients with OBPI.   "
32124|NCT02865291|"     The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of     accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for     self-insertion to seal and help prevent the involuntary leakage of stool, liquids and gases     from the rectum.      The purpose of the study is to demonstrate that the ForConti FIMS is safe and that it     improves management of fecal incontinence and improves quality of life.      Patients will record bowel events in a daily diary over a 5 week period, which includes 1     week of adjustment to device use, 2 weeks without using the device followed by 2 weeks using     the device. Quality of Life questionnaire will be completed before and after use of the     device. Stool leakage data collected when the device is not being used will be compared with     data collected during use of the device to determine effectiveness.   "
32125|NCT02865278|"     Randomized placebo-controlled crossover study during which participants undergo two different     experimental days. The participants consume a red grape based- drink (polyphenols: 300 mg/100     ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). After 3     hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are     taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal     to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate     bioavailability.   "
32126|NCT02865265|"     The association between ultrasound-guided Pecs II block and parasternal block can represent a     valid alternative in the management of acute and postoperative pain syndrome after     quadrantectomy with or without axillary dissection.   "
32127|NCT02865252|"     Osteoarthritis (OA) is the most prevalent form of arthritis and is reported to be the most     important reason behind functional disability and musculoskeletal disorders among aged     individuals. OA is a total joint failure; represented by pathological damage to articular     cartilage, that affects bone, menisci, synovium, ligaments, and neuromuscular tissue. Knee     OA could be responsible for pain and functional disability in 19.2% of individuals aged more     than 45 years in the Framingham study and in 27.8% of such individuals in the Johnston County     Osteoarthritis Project. However, in the third National Health and Nutrition Examination     Survey (NHANES III), nearly 37% of individuals aged 60 years or older had radiographic knee     OA. Oliveria et al. (1995) reported that age- and sex-standardized incidence rates of     symptomatic hip, knee, and hand OA were 88, 240, and 100/100,000 person-years, respectively.     In addition, the incidence rates of symptomatic OA of the knee, hand, or hip increased     rapidly at age 50 and then levelled off beyond age 70. There were not enough data to report     the prevalence of OA in Arabic countries. However, a cross-sectional study performed in Saudi     Arabia demonstrated radiographic knee OA in 53.3% of men and 60.9% of women, while about 18%     of women and 10% of men had symptomatic OA. Although it is well established that OA is mainly     caused by damage occurring in the joint because of degeneration and inflammation, there is no     known cure for OA and our understanding of the pathological aetiology of OA is still     deficient and poorly understood.      The primary objective of this study is to investigate the immediate and the carry-over effect     of MWM on pain and function in patients with knee OA. A secondary objective is to evaluate     this effect among those patients who demonstrate features of central sensitization.   "
32128|NCT02865239|"     Breast MRI is performed in prone position which causes a number of questions. Indeed, the     correlation with mammography and echography and the identification of preoperative lesions     can be complex as echography and surgery are carried in supine position while mammography is     performed in standing position.      Moreover, the prone position is often considered as uncomfortable by the patients. However,     there is few publications in the literature on breast MRI in decubitus position.   "
32129|NCT02865226|"     Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective     control and a reduction of postoperative morbidity and mortality.      The gold standard for local analgesia is the thoracic epidural. However, this technique can     be dangerous with severe complications.      The paravertebral block showed comparable efficacy to the thoracic epidural for local     analgesia . In addition, it has a better safety profile. There are several installation     techniques. The difference in efficiency of these laying techniques is unknown.   "
32155|NCT02864875|"     The objetive of this study is to compare the treatment of two groups of politrauma patients     that have fibrinogen deficiency (Fibtem < 9) diagnose by thromboelastography (ROTEM) but do     not have clinical or laboratorial signs of coagulopathy at emergency room admission. One     group will receive fibrinogen concentrate (Haemocomplettan) and the control group will be     clinically followed. If any of the groups show clinical signs of coagulopathy it will be     treated by anesthesiologist decision.   "
32130|NCT02865213|"     This experimental study will evaluate the effect of different methods for the molar intrusion     (compared with the control group) in adolescent and adult patients with open bite     malocclusion. The study sample will consist of 45 patients with anterior open bite. The     sample will be randomly allocated into two experimental groups, in addition to a control     group.      The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi     and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be     used in the first treatment group, while miniscrews will be used in the second treatment     group. In the control group, only OBA will be used. The skeletal and dentoalveolar changes     occurring after intrusion of posterior teeth will be assessed by using posteroanterior and     lateral cephalometric radiographs. Pre- and post- treatment changes for each group will be     evaluated, in addition to the comparison of the post-treatment skeletal and dental changes     that occurs between groups.   "
32131|NCT02865200|"     Aim: This study was planned for comparing physical activity levels, nutrition quality and     quality of life of the individuals that are diagnosed with and without metabolic syndrome     (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).      Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and     (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic     characteristics of the individuals that participated the study were registered with a survey     form. The long form of the International Physical Activity Questionnaire was used for     determining physical activity levels of the individuals; whereas total numbers of daily steps     were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS)     was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for     the assessment of health-related qualities of life of individuals and Beck Depression     Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis     and anthropometric measurements of individuals were also taken.   "
32133|NCT02865174|"     Our purpose of this study is to conduct a prospective randomized controlled trial to     investigate the blood-conservation effect of this two topical hemostatic agents in primary     TKA procedures in patients with a risk of thromboembolic events. We will also observe if     there is increased risk of thromboembolism by use of topical hemostatic agents.   "
32134|NCT02865161|"     This study is conducted to study the efficacy and safety of Niselat in patients with     osteoarthritis.   "
32135|NCT02865148|"     Research indicates that up to two-thirds of patients with advanced cancer experience     significant symptom burden (e.g., anxiety and depression, pain, fatigue), yet these symptoms     are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach     patients strategies to increase their sense of self-efficacy to manage symptoms may be     helpful in alleviating multiple cancer-related symptoms. The efficacy of CBT protocols for     reducing distinct symptoms in early-stage breast cancer has been shown; however the role of     CBT protocols for multiple symptoms in late-stage cancer is less clear. The current study     aims to investigate the feasibility and acceptability as well as obtain an initial estimate     of efficacy of a novel, cross-cultural CBT intervention that addresses multiple symptoms in     advanced breast cancer patients. The target outcomes of intervention will be reduction in     symptoms of anxiety and depression, pain, and fatigue. A randomized controlled design will     compare patients receiving a CBT protocol to a waitlist control in both Singapore and US     patients. The larger goal of this collaborative effort is to determine the scalability of     such an intervention that can potentially provide needed symptom burden relief to advanced     cancer patients.   "
32136|NCT02865135|"     This research study is studying a therapeutic vaccine, named DPX-E7, as a possible treatment     for Human Papilloma Virus or HPV related head and neck, cervical or anal cancer (positive for     HLA-A*02).   "
32137|NCT02865122|"     The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620     compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old)     with SBS following surgical resection   "
32138|NCT02865109|"     To provide access to nusinersen to eligible patients with Infantile-onset Spinal Muscular     Atrophy (SMA) (consistent with Type 1) to address a high-unmet medical need.   "
32139|NCT02865096|"     This study is attempting to determine whether there is any effect (worsening or improvement     of sexual function) after marijuana consumption. Both users and non users of marijuana will     be given the opportunity to participate by completing a questionnaire.   "
32140|NCT02865083|"     The purpose of this study is to investigate the effects of the Traxi Pannus retractor in     obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus     retraction techniques. Patients will be randomized to the use of the Traxi retractor during     Cesarean section (treatment group) or the use of traditional pannus retraction techniques     (control group). The primary outcome to be followed is surgical site disruption. The     investigators will also assess the duration of surgery or length of time from skin incision     to delivery of the infant, change in hemoglobin, estimated blood loss, postoperative length     of stay, need for hospital readmission or emergency room visits, or other complication rates     between the two groups.   "
32141|NCT02865070|"     This is a pilot study is to test a wireless, skin-sensor device against current technology in     the NICU to monitor vitals   "
32142|NCT02865057|"     Vaginal exams are used routinely in labor to assess cervical dilation and position of the     baby (facing anterior, facing to the right or left side, facing towards maternal spine). This     technique has a widely variable accuracy rate (24.0-85.6%). Ultrasound has been used to help     confirm or correct the vaginal assessment by obstetricians, but has not been used to assess     the utility of immediate feedback to improve the accuracy of vaginal assessment by physicians     in training. The investigators plan to use ultrasound assessment to determine if this     education is effective in increasing accuracy in the resident population.   "
32143|NCT02865044|"     The objective of this study was to evaluate and compare the acute bioavailability of EPA and     DHA in wax ester form provided as a dietary supplement compared to a well-studied and defined     ethyl ester formulation in generally healthy men and women.   "
32156|NCT02864862|"     The purpose of this study is to evaluate the esthetic outcomes following immediate implant     combined with the autogenous tissue graft or acellular dermal matrix compared to immediate     implant alone.   "
32144|NCT02865031|"     Purpose: To determine the safety, tolerability, and efficacy of human recombinant decorin     protein, a transforming growth factor ß (TGFß) inhibitor in preventing proliferative     vitreoretinopathy (PVR) in patients with perforating globe injuries.      Methods: This is a prospective, single-center, open-label, interventional case series. A     single intravitreal injection of decorin 200ug (n=4) and 400ug (n=8) was given within 24     hours of injury. Pars plana vitrectomy with silicone oil injection was done if indicated. ERG     was done before injections, at day 10, and 3 months. Serial plasma decorin levels were     assessed before injections, day 3, 5, and 10 post-injection. Clinical assessment included     globe survival, retinal attachment rate, and PVR evaluation.   "
32579|NCT02859324|"     CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in     combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who     have progressed after or were intolerant to no more than 2 previous systemic therapies for     unresectable HCC, or are naïve to systemic therapy.   "
32145|NCT02865018|"     Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system.     Patients have relapses (also known as attacks) which are often quite severe and leave them     with significant disability. Without treatment, within 5 years 50% of NMO patients are blind     in one or both eyes or require walking assistance (cane, walker or wheelchair).      NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune     systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain     cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a     cascade of events involving the immune system which eventually leads to damage to the nervous     system. This ultimately leads to disability, some of which is permanent.      Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4     antibody. However, recent experiments in animal models of NMO have shown the importance of     what happens inside the central nervous system after the antibody binds to the nervous system     cell. Specifically, researchers have noted the importance of a specific cell type,     eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they     could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular     over-the-counter allergy medicine.      Cetirizine is already known to be safe and well-tolerated in the general population. In this     study, the researchers plan to add cetirizine on to patients' current NMO treatment. The     researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO     patients have less relapses and therefore less disability over the course of the year     following initiation of treatment. The researchers also plan to study how cetirizine changes     the immunological profile in NMO patients by examining blood and cerebrospinal fluid.   "
32146|NCT02865005|"     Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the     treatment of acne vulgaris.   "
32147|NCT02864992|"     This study will look at how effective the study drug (tepotinib) is at stopping the growth     and spread of lung cancer. This study will also measure a number of other things including     safety of the study drug and the side effects, how body processes the study drug, or how the     study drug affects your quality of life. The study also has an optional pharmacogenetic     research part. Pharmacogenetic research is an important way to try to understand the role of     genetics in human disease and how genes impact the effectiveness of drugs, because     differences in genes can change the way a person responds to a particular drug.   "
32148|NCT02864966|"     This is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a     panel of healthy adult subjects. The patches will be affixed to the back and remain under     occlusion for 24 hours. They will then be assessed at 30 minutes and 24 hours post patch     removal.   "
32149|NCT02864953|"     This study evaluates the use of the investigational drug CIRARA versus placebo in patients     with a large hemispheric infarction.   "
32150|NCT02864940|"     The study aim is to determine if periodic online cognitive exercises (Lumosity) improve     memory function in ruptured cerebral aneurysm patients with disabling baseline memory     deficits within the first 24 months after rupture. Half of the subjects will be randomized to     use Lumosity-designed online cognitive exercises and half will serve as an active control     group performing online crossword puzzles.   "
32151|NCT02864927|"     The purpose of the study is to perform the re-examination of Menactra® administered in the     routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.      Primary objective:        -  To describe the safety profile after 1 dose of Menactra® administered from 9 months to          55 years of age under standard health care practice.   "
32152|NCT02864914|"     Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose     cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2     diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk     management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a     post-authorisation safety study (PASS) to evaluate the liver and renal safety of     empagliflozin. The study will also evaluate the risks of severe complications of urinary     tract infections (UTIs) and genital infections. To evaluate the association between     empagliflozin use and mentioned outcomes routinely collected health information from the     Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of     National Statistic will be used. This PASS will be conducted through an observational cohort     study among adult patients with T2DM and at least 12 months of continuous enrolment in the     CPRD where new users of empagliflozin will be compared to new users of other SGLT2 inhibitors     and to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the     crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and     secondary outcomes. The primary outcomes will be: acute liver injury (ALI), acute kidney     injury, hospitalization due to severe complications of urinary tract infection, and genital     infections. The secondary outcomes will be: ALI in patients without predisposing factors,     chronic kidney disease, outpatient severe complications of UTI, and genital infections     resulting in hospitalization or systemic treatment.   "
32153|NCT02864901|"     This study is a Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1),     multiple dose, single center study to evaluate the safety and proof of concept in a chewing     gum formulation 3 times per day over 4 treatment days.   "
32154|NCT02864888|"     The primary objective of this protocol study is to investigate the effect of Antineoplaston     therapy on the QT/QTc interval in study subjects age 3 to 21 years with newly-diagnosed,     diffuse, intrinsic brainstem glioma. This investigation is to be conducted in parallel with a     phase 3 efficacy and safety study of combination Antineoplaston therapy + radiation vs.     radiation alone (BRI-BT-52).   "
32157|NCT02864849|"     This study is designed to test the efficacy and safety of total neoadjuvant induction and     consolidation CapeOX plus neoadjuvant intensity modulated radiotherapy with concurrent     capecitabine for MRI defined high-risk rectal cancer.   "
32158|NCT02864836|"     The distribution of stable (non-radioactive) isotopes in living organisms is increasingly     studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive     organisms, but also in mammals.      The scientific community shows a growing interest in the study of the isotopic distribution     of Cu in humans: this distribution can vary according to gender or nutrition. Concerning     pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in     cirrhosis.      Additionally, a promising area of study focuses on the role of Cu in cancerous tumors,     neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.      Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are     important: platinum penetrates into the cell through a Cu receptor, it interacts with the     regulation mechanisms of Cu and platinum.      Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in     patients with breast tumor and of Cu in patients presenting breast as well as colorectal     tumors.      The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results     highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of     Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast     tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum     and the isotopic modifications happen earlier than usual modifications of biochemical tumor     markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3,     Carcinoembryonic antigen (CEA).      Currently, there is no information about the distribution of the stable isotopes of Cu in     head and neck tumors.      The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in     tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor     types, head and neck tumors and lymphomas, will be also investigated in order to determine if     this distribution is specific of a tumor type or not.      In case of positivity of this variation, the prognostic interest of these parameters will be     evaluated.   "
32159|NCT02864823|"     Necrotizing scleritis with severe ischemia is refractory to conventional treatment because of     avascular necrosis.      The investigators assessed the therapeutic efficacy and safety of autologous perichondrium     transplantation in patients with severe ischemic necrotizing scleritis, and analyzed the     therapeutic effects.   "
32160|NCT02864810|"     [18F]GP1 targets platelet GPIIb/IIIa receptor in thrombus. [18F]GP1 PET/CT imaging will     noninvasively assess thrombus in whole body with good sensitivity with information of     thrombus. Safety, pharmacokinetics, biodistribution, internal radiation dosimetry and     diagnostic performance of [18F]GP1 will be assessed in all subjects.   "
32161|NCT02864797|"     Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an     important part of the female cancer in France with more than 15 000 new cases in 2012. As     considerable progress have been made in diagnostic and therapeutic strategies, an important     part of the gynecologic cancers are diagnosed at an early stage and globally, the after     treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of     evident interest to study health related Quality of Life (QoL) among these patients who will     continue to live after their cancer and to consider QoL as a primary end-point, beyond     overall survival.      The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a     working group initiated in Besançon and whose goal is to investigate QoL of gynecologic     cancers' patients. It gathers several entities from the hospital of Besançon, namely the     Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology Unit.     The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical     practice, with the main objective of longitudinally collecting and analyzing QoL data of     these women.      The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besançon, has started in     September 2015 with the goal of assessing the feasibility of the cohort. The feature of this     study is that patients answer to QoL questionnaires using tablets computer and the     Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions     to collect patient reported outcomes is drastically increasing those last years. It has been     underlined that routinely collecting symptoms could increase both QoL and survival among     cancer patients. It enables to use these data in real-time in routine practice by presenting     QoL scores to physicians in simple graphical histograms for both transversal and longitudinal     measurements and it ensures a reliable data collection.   "
32162|NCT02864784|"     Studies objectives:      To evaluate the safety, tolerability and efficacy of AMOR-1 given in combination with ZA or     with Denosumab as compared to placebo given with ZA or with Denosumab as outline below:        -  Safety and Tolerability:        -  Adverse events (AEs) and serious AEs        -  Safety laboratory measurements        -  Hypercalcemic and hypercalciuric episodes        -  Treatment withdrawal due to AEs and overall      Efficacy:        -  Skeletal Related Events (SREs)        -  Measurable and evaluable disease progression        -  Progression Free Survival (PFS)        -  Pain assessment via the VAS scale   "
32163|NCT02864771|"     The purpose of this study is to identify markers of increased risk for incident ventricular     arrhythmias and cardiovascular events in patients already being treated with an implantable     cardioverter-defibrillator (ICD) by exploring patient history and clinical findings,     biological markers, ECG markers, and echocardiographic markers.   "
32164|NCT02864758|"     The purpose of the study is to compare the one-year and two-year risk of each of the     following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death     between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during     drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus     dabigatran   "
32165|NCT02864745|"     ICU acquired weakness contributes (ICUAW) to poor functional outcome in survivors of critical     care. Most damage occurs during the first week of critical illness when patients are unable     to cooperate with conventional active rehabilitation. Functional electrical     stimulation-assisted cycle ergometry (FES-CE) may improve muscle function and long-term     outcome. Methods: Assessor-blinded pragmatic single-centre randomized controlled trial.     Adults (n=150) mechanically ventilated for < 48 hours from 4 ICUs who are estimated to need     >7 days of critical care will be randomized to receive either FES-CE-based intensified     rehabilitation or routine care, which will continue until ICU discharge. Primary outcome:     Quality of life as measured by SF-36 score at 6 months. Secondary outcomes: functional     performance at ICU discharge, cross sectional muscle diameter and nitrogen balance, and     muscle power. In a subgroup we will assess insulin sensitivity and perform skeletal muscle     biopsies to look at mitochondrial function, fibre typing and regulatory protein expression in     response to FES-CE.   "
32166|NCT02864732|"     The purpose of this study is to investigate the feasibility of applying neuromuscular     electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and     whether the electrical stimulation improve pain, function and muscle strength.   "
32167|NCT02864719|"     The primary aim was to examine the feasibility of an Energy Conservation + Problem Solving     Therapy (EC+PST) intervention delivered over the telephone and to evaluate the preliminary     intervention effect on fatigue impact in daily activities in post-cardiac arrest (CA) adults     with chronic fatigue.   "
32168|NCT02864706|"     This protocol is written to describe the procedures for a single 5, 6 or 7 year follow-up     control visit of patients who participated in the 12-month SCHEDULE-study and the following     3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit is to examine     the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus     (Certican®) and early elimination of cyclosporine (CsA), compared to standard     immunosuppressive regimen including CsA, on renal and heart function. During the time period     of this follow-up examinations, this visit will be performed as part of a routine annual     visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).   "
32170|NCT02864680|"     This study will evaluate the impact of regular use of cannabis on the spatial sensitivity of     magnocellular system (visual event-related potential, visual ERP).      Secondary purposes of this study are to evaluate the impact of regular use of cannabis on the     temporal sensitivity of magnocellular system (visual event-related potential), on the     dynamics of cortical visual processing during face perception test (visual event-related     potential) and on functioning of retinal photopic and scotopic systems (electroretinogram).      The ancillary study is a genetic analysis of a group of candidate genes that aims to identify     biomarkers for changes in visual processing. This will allow to distinguish among more     homogeneous and specific groups in future studies on larger cannabis user population. This     ancillary study concerns all participants subject to their informed consent (facultative     study).   "
32171|NCT02864667|"     Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning     Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector     PaxScan 4030MCT. The modified detector is essentially identical to the previous model except     a different detector housing which allows a narrower dead-space between the active area and     the top of the housing.      The benefit of the modified detector is that it allows Koning to modify the patient exam     table, achieving a flatter surface in the center. The flatter surface will increase patient     comfort and improve workflow.      Meanwhile, flatter surface may also affect patient positioning and the coverage of the     breast. The adequacy of the overall image quality with the new table/detector should be     verified by radiologists.   "
32172|NCT02864654|"     Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic     digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of     muscle injury. All patients will receive cell therapy. This is a single arm study with no     control.   "
32173|NCT02864641|"     The purpose of this project is to test the efficacy of Planet K, a mobile and web-based     technology infrastructure specifically designed to (a) enhance youths' chronic kidney     disease- and treatment-related knowledge through interactive and game-based educational     materials; (b) support adherence to the treatment regimen through customized task prompts via     mobile and web-based delivery; and (c) promote patient-provider communication through     real-world data collection and feedback loops. Investigators will examine the effectiveness     of the Planet K mobile app and website in improving treatment adherence, disease-related     knowledge, transition readiness, condition management, and the psychological correlates of     these variables in adolescents and young adults with chronic kidney disease (CKD).   "
32174|NCT02864628|"     A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two     vaccinations with MVA-BN-RSV vaccine or placebo.   "
32175|NCT02864615|"     Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic     body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR,     mTOR or immune checkpoint inhibitors.   "
32176|NCT02864602|"     This is a volunteer study examining the effect of different doses of IV dexamethasone on     prolongation of median nerve block in the forearm.   "
32177|NCT02864589|"     The purpose of this study is to evaluate the feasibility and acceptability of two different     modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and     adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal     Tic Disorder (PTD).   "
32178|NCT02864576|"     Cognitive remediation (CR) and aerobic exercise have separately shown promising results in     schizophrenia cognitive improvement, despite this, the impact in improving functionality is     still limited. Aerobic exercise increases Brain Derived Neurotrophic Factor (BDNF) levels,     promoting neuronal and cognitive plasticity, which can maximize the impacts of CR. The aim of     this randomized controlled trial is to study the efficacy of a 3-month intensive program that     combines CR plus physical exercise comparing it to cognitive remediation plus a control     activity.   "
32179|NCT02864563|"     Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and     evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic     pattern is an important prognostic marker which might be taken into account for treatment     stratification.      This protocol deals with a prospective analysis of the genomic profile established by     CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in     France, to obtain genomic profiles and being able to determine their prognostic impact in the     various protocols of treatment. The objective of this study will be a better therapeutic     stratification in the future trials, studies or protocols of treatment.   "
32180|NCT02864550|"     Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual     and other men who have sex with men (gbMSM), with the potential for significant sequelae -     particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of     this STI have prompted a search for novel prevention solutions. A recent pilot study of daily     doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative     approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure     prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other     infections. The overarching goal of this project is to determine whether the daily use of     doxycycline is an efficacious and acceptable intervention for syphilis prevention in     high-risk, HIV-positive gbMSM.   "
32181|NCT02864537|"     The aim of the study was to compare self-management of anticoagulant treatment with     conventional anticoagulant treatment in Norway.   "
32182|NCT02864524|"     Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia     syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program     for lower thoracic and cervical spine.      Study Design: A single-blind randomized controlled trial was conducted on patients with     fibromyalgia syndrome (FMS).      Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an     experimental group receiving manipulative and massage therapy, or to a control group for     exercise program.   "
32183|NCT02864511|"     The purpose of this study is to describe a safe and consistent technique for neck     rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the     intervention and determine the patients that would benefit most.   "
32185|NCT02864485|"     Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor     prognosis. In patients with resectable disease, surgery offers a distinct survival benefit.     This study will offer live donor liver transplantation (LDLT) to select patients with     unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on     standard chemotherapy. Potential participants will be evaluated for liver transplant     suitability and must also have a willing, healthy living donor come forward for evaluation.     Those participants who undergo LDLT will be followed for survival, disease-free survival and     quality of life for 5 years and compared to a control group of participants who drop out of     study prior to transplantation due to reasons other than cancer progression.   "
32186|NCT02864472|"     The aim of this study is to compare the efficacy of early intervention of PDT combination     compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV     patients showing insufficient response with initial loading dose.   "
32187|NCT02864459|"     When attempting to wean a patient from the ventilator, even if he/she passes the spontaneous     breathing test, 10-20% of the time extubation failure occurs and the patient is reintubated.     When the patient is reintubated the mortality rate increases and the length of intensive care     unit stay is also increased. It is vital to intensively assess the patient before extubation     and correctly predict extubation success. Muscular ultrasound may be helpful in these     situations.   "
32188|NCT02864446|"     Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell     damage, has recently been proposed as a clinically useful measure in the early detection of     necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in meconium     obstruction of prematurity (MOP). This study aimed to evaluate urinary i-FABP in MOP patient     as a marker for early detection.   "
32189|NCT02864433|"     The investigators aim to evaluated a public health program in Haiti that introduced an oral     cholera vaccine as part of comprehensive control efforts for a major cholera epidemic.     Although the vaccine (Shanchol(R)) had been demonstrated to be very safe, and effective at     preventing cholera in many settings, it had not extensively been used to control an outbreak,     and it had not been extensively studied in populations that were previously naive to cholera     (i.e. countries that had never had cholera before). This cholera epidemic was the first ever     report of cholera in Haiti.      After the cholera vaccination campaign was complete, the investigators aimed to evaluate the     field efficacy of the vaccination campaign by evaluating the number of cases of cholera, and     determining if cholera patients had been vaccinated. The investigators compared the rate of     vaccination in cholera cases to controls from the community that had not had cholera in a     case-control study.      The investigators also performed a second study - a bias-indicator study - that enrolled     patients with non-cholera diarrhea, and community controls. The role of the bias-indicator     study was to evaluate for potential sources of bias, since the investigators could expect     that cholera vaccination should have no effect on non-cholera diarrhea.   "
32190|NCT02864420|"     The investigators propose a home hospital model of care that substitutes for treatment in an     acute care hospital. Limited studies of the home hospital model have demonstrated that a     sizeable proportion of acute care can be delivered in the home with equal quality and safety,     reduced cost, and improved patient experience.   "
32191|NCT02864407|"     To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with     COPD in a routine clinical practice setting   "
32192|NCT02864394|"     The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus     docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death     ligand 1 (PD-L1) positive tumors who have experienced disease progression after     platinum-containing systemic therapy. The primary hypothesis of this study is that     pembrolizumab (MK-3475) prolongs overall survival (OS) and progression-free survival (PFS)     compared to docetaxel in participants with PD-L1 positive tumors   "
32193|NCT02864381|"     The primary objective of this study is to evaluate and compare the efficacy of andecaliximab     (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent     gastric or gastroesophageal junction (GEJ) adenocarcinoma.   "
32194|NCT02864368|"     Newly-diagnosed glioblastoma (GBM) with complete or partial surgical resection, CMV     seropositive patients will be eligible to enroll on this 2-arm randomization trial. Following     standard of care chemoradiation, eligible subjects will be consented and randomized to cycles     of either 5-day standard of care post-radiation temozolomide (TMZ) or 21-day dose-intensified     TMZ. Subjects will receive tetanus-diphtheria (Td) pre-conditioning on day 22 of the first     post-radiation cycle of TMZ and the following day, receive the first of 3 every other week     via intradermal (i.d.) injections of the study drug cytomegalovirus peptide (PEP-CMV), a     vaccine mixture comprised in 2 components (referred to as Component A and Component B). The     subjects will resume cycles of TMZ, resulting in a ~35-day delay between cycle 1 and 2, and     continue PEP-CMV vaccinations every month with cycles of TMZ and then monthly to a maximum of     20 vaccines unless progression occurs.   "
32195|NCT02864355|"     The objective of this prospective, randomized controlled study is to ascertain whether the     perioperative use of the FloTrac device to guide fluid and vasopressor management during     esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary     complications; however, the secondary outcome of decreasing patient morbidity (acute renal     injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital     stay.   "
32196|NCT02864342|"     A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on     adherence in COPD patients   "
32197|NCT02864329|"     Basic and clinical research is revealing that various noncoding and small RNAs play important     and diverse roles in germ cell development and quality, including X/Y silencing during     meiosis, gene regulation, DNA damage responses, and protection of the genome against     transposable elements. Indeed, mammalian germ cells are known to harbor multiple small RNA     species, including small interfering RNAs (siRNA), microRNAs (miRNA), and germline- specific     PIWI- interacting RNAs (piRNA). However, their mechanistic roles in gametogenesis and human     infertility are largely uncharacterized. The goal of this study is to elucidate the role of     small RNA pathways in the events that give rise to viable euploid gametes. Four projects and     three cores are included in this study.   "
32198|NCT02864316|"     The purpose of this study is to determine whether Nivolumab is effective in the treatment of     radiation-induced solid tumors.   "
32199|NCT02864303|"     Although saliva is not generally regarded as one of the most interesting biological fluids,     the fact that it can be sampled using simple, noninvasive methods makes it an interesting     alternative to cerebrospinal fluid (CSF) or blood for diagnostic purposes. The use of     salivary diagnostics is moreover increasing these past 10 years, as shown with the abundant     literature as well as various clinical trials. Saliva collection which is now well     standardized has the major advantage of being simple and non-invasive. An original study had     already discussed possible changes in the salivary composition in Alzheimer's disease (AD).     The feasibility and the potential interest of measuring saliva concentration of the amyloid     peptides was reported in an article published recently. The prospect of using saliva for     early diagnosis and monitoring of AD is thus of major interest and the objective of the     current trial.   "
32200|NCT02864290|"     The purpose of this study is to evaluate the safety and tolerability of AGS62P1 given at two     dosing schedules (Schedule A, every three weeks [Q3W] or Schedule B, weekly), in subjects     with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In     addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the     anti-leukemic activity of AGS62P1.   "
32201|NCT02864277|"     The aim of this study is to compare outcomes of conventional perioperative care with those of     an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing open     abdominal surgery for gynecologic cancer or suspected gynecologic cancer. Investigators     hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of     hospital stay, without increasing readmission rates. ASD   "
32202|NCT02864264|"     The primary purpose of this study is to determine if single and multiple doses of BMS-986184     are safe and well tolerated in healthy male and female subjects. The primary purpose of the     proof of mechanism study is to determine safety and efficacy in patients with ulcerative     colitis.   "
32204|NCT02864238|"     The economic burden of health care is becoming a greater burden from year to year. Medicare     spending, which represented 20 percent of national health spending in 2013, grew 3.4 percent     to $585.7 billion, a slowdown from growth of 4.0 percent in 2012. This slowdown was     attributed largely to slower enrollment growth and impacts of the Affordable Care Act (ACA)     and sequestration. Per-enrollee spending in 2013 grew at about the same rate as 2012.      The push to create Accountable Care Organizations (ACO) has taken these initiatives a step     further. The goal would be to move away from a fee for service system and base reimbursement     on quality of care. Clinical metrics, re-admissions, and patient satisfaction in categories     of acute myocardial infarction, congestive heart failure, pneumonia, surgeries and healthcare     associated infections will be the foci for 2013. Centers for Medicare and Medicaid Services     (CMS) has also initiated a valve bundled payment system that encompasses total patient care     for 90 days, including readmissions.      Leapfrog and the ACO movement along with the nonprofit group Institute for Health Care     Improvement have placed quality and cost effectiveness into the spotlight for clinicians in     the ICU and beyond. While clinicians have always been focused on evidence based therapies     with little concern for cost, in the new era of healthcare understanding cost, value and     effectiveness of therapies will be key for improved patient outcomes and institutional     solvency in trying economic times.      Vanderbilt elected to enroll in the CMS valve bundle trial. The Leadership team in the heart     and vascular institute identified the importance of an electronic medical record that     includes display and utilization of key drivers of quality and success across the continuum     of care (Preoperative assessment to discharge up to 90 days) in the bundled payment model of     care. A multidisciplinary team was developed in conjunction with nurses, midlevel providers,     multi-specialty physicians, case managers, informatics specialists, and performance     improvement representatives to develop an electronic pathway of care using evidence based and     best practices for cardiac surgery.   "
32205|NCT02864225|"     Background:      Identification and measurement of fetal heart tracings throughout pregnancy and labor is     crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most     common indications for operative vaginal delivery or cesarean section. Therefore, management     of labor requires reliable and accurate information about fetal heart rate.      In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart     rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic     changes (accelerations or decelerations). In each stage of labor the tracing may have     different characteristics, with variable decelerations much more common at the end of the     second stage of labor.      Objective:      To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the     reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the     same patients.   "
32206|NCT02864212|"     The aim of this observational study is to create a data base to extract feature of     fast-acting drugs that can be monitor in real time to design control strategies based on high     order sliding mode controller to create a robust drug infusion system.   "
32207|NCT02864199|"     This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum     concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and     ribavirin combination therapy following single and multiple doses in participants with CHC     infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving     hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target     sample size is 48 individuals.   "
32208|NCT02864186|"     That study have the primary purpose identify if exist difference to the healing and quality     of life between women that use of a surgical support bra, common support bra and without     support bra after coronary artery bypass graft surgery.      To do this, will be assessed pain, healing of the wound (dehiscence, infection) and quality     of life life through specific instruments.   "
32218|NCT02864056|"     This is a two-centre parallel group randomised controlled trial with an embedded process     evaluation and intervention pilot phase (details not provided in this summary). The overall     research question is: Can a Tai Chi exercise programme prevent falls among people with     dementia (PWD), specifically among older PWD living at home?      Primary Outcome measure:      • dynamic postural balance (as a surrogate for falls).      Secondary outcome measures:        -  to explore the effects of a Tai Chi exercise programme on static and functional postural          balance, fear of falling, cognitive functioning, falls, and quality of life. Also to          explore the effects of a Tai Chi exercise programme on their informal carer's dynamic          and static postural balance, quality of life, and carer burden        -  to determine the acceptability and safety of the Tai Chi intervention        -  to inform the design of a future definitive clinical trial.   "
32460|NCT02860871|"     The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave     Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients from     other causes of joint effusion by analyzing ex vivo joint fluid samples collected during     routine clinical care.   "
32461|NCT02860858|"     Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in     patients with symptomatic macular PCV.   "
32209|NCT02864173|"     Postoperative cognitive dysfunction (POCD) presents as a long-lasting decline in cognitive     function following surgery. Recognized as an important neuropsychological complication of     anesthesia and surgery, POCD occurs predominantly in elderly patients, and even after minor     procedures. It affects 41% of patients over the age of 60 years one week after major     noncardiac surgery, and persists until the third postoperative month in 13% of cases. POCD     has an adverse impact on quality of life, may result in prolonged hospitalization and     increased health care costs, and is associated with the risk of leaving the labor market     prematurely and dependency on social transfer payments, as well as increased one-year     mortality. Elderly patients are particularly at risk. Other risk factors include a     pre-existing cognitive impairment, cerebral, cardiac or vascular disease, diabetes, alcohol     consumption and a lower level of education. The occurrence of postoperative delirium seems to     predispose patients to POCD. However, POCD itself is not associated with the development of     dementia.      The pathogenic mechanism leading to POCD remains unclear. Numerous etiologic pathways have     been suggested: cerebral ischemia due to impaired intraoperative cerebral perfusion and/or     oxygenation, systemic inflammation and the effect of proinflammatory cytokines on the brain,     altered cholinergic neurotransmission, anesthetic neurotoxicity, hormonal changes induced by     surgical stress, sleep or circadian disturbances, or genetic factors.      Several studies have explored possible associations between a specific genotype and POCD;     however, these were predominantly performed in patients undergoing cardiac surgery or carotid     endarterectomy. Previous reports primarily focused on the analysis of the apolipoprotein E     genotype as a predisposing factor for POCD. Results of some of these studies have been pooled     in a recent meta-analysis. Other studies have investigated polymorphisms of the human     circadian clock gene HPER3, complement, cytochrome P450, platelet glycoprotein IIIa,     phosphodiesterase 4D, P-selectin, C-reactive protein, and the inducible nitric oxide synthase     promoter.      The primary aim of this retrospective study of available cohort data is to investigate a     specific genotype and to identify single nucleotide polymorphisms (SNPs) which may predispose     elderly patients undergoing major noncardiac surgery to POCD.   "
32210|NCT02864160|"     Language barriers continue to impede access to quality care for limited English proficient     populations. Recent research has demonstrated that access to language concordant providers     increases quality of care. This project evaluates the efficacy and acceptability of a model     intervention to improve second language proficiency, patient-centered communication, and     clinical competency of nurse practitioner students who care for Spanish-speaking patients     with diabetes.   "
32211|NCT02864147|"     This is a randomized Phase II, three arm control trial in patients with Cervical     Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3     meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study     pathologist to confirm diagnosis. HPV DNA test and HPV 16/18 genotyping will be performed     from endocervical cytobrush samples to determine HPV status associated with the dysplasia.      Patients who have CIN 2/3 with HPV+ disease will be enrolled in this study. Patients will be     randomized to one of three arms: observation only (control), imiquimod only, imiquimod +     9-valent HPV vaccine.   "
32212|NCT02864134|"     BACKGROUND AND OBJECTIVES: The recent expansion of the applications of optical coherence     tomography (OCT) demonstrated a higher correlation between the analysis of ganglion cells and     visual function, in comparison with the analysis of the nerve fiber layer for several     diseases of the optic nerve. Atrophy of the ganglion cells tends to induce the visual     function deficits. In the case of optic neuritis, inflammation of the optic nerve causes a     deficit of visual function initially with low vision, color blindness and visual field.     Secondary atrophy of ganglion cell can result. The purpose of the study is to evaluate the     correlation between the analysis of ganglion cells at the time of diagnosis of optic neuritis     and the resulting visual acuity at 6 months and visual function (visual acuity, color vision     and perimetry) 1 year regardless of treatment. A predictive effect could help predict the     patient's clinical course and management of uncertainty and anxiety. MATERIALS AND METHODS:     An assessment at diagnosis and follow-ups at 6 months and 1 year with a measurement of best     corrected visual acuity, a test color vision HRR (Hardy-Rand-Rittler), an OCT with analysis     of ganglion cells and perimetry Humphrey 30 -2 fast will be done. Simple linear and logistic     regressions will be used. RESULTS: We expect that there will be a significant association     between atrophy of ganglion cells in the diagnosis and residual visual function after an     episode of optic neuritis. We believe that the initial atrophy is associated with poorer     visual prognosis. CONCLUSION: A predictive effect could help to inform the patient about the     evolution of the disease and provide early visual rehabilitation.   "
32213|NCT02864121|"     High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development.     Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical     cancer development. The aim of this study is to validate the integration of the HPV-HR as an     appropriate biomarker of the severity of precancerous lesions and progression of cervical     lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular     Combing technology, which allows direct and high-resolution visualization of the integration     of high-risk HPV genomes.   "
32215|NCT02864095|"     The purpose of this study is to compare the blood loss of intravenous and topical     administration of low dose epinephrine plus combined administration of intravenous and     topical tranexamic acid for primary total hip arthroplasty.   "
32216|NCT02864082|"     Congenital ichthyosis (CI) is a large, heterogeneous family of inherited skin disorders of     cornification resulting from an abnormality of skin keratinization, such as scaling and     thickening of the skin. Treatment options include keratolytic agents, which can abruptly lead     to extensive shedding or peeling of scales. PAT-001 primarily acts as a keratolytic agent;     thus, making it a potential drug candidate for the treatment of skin disorders associated     with hyperkeratinization, such as CI. The current study intends to evaluate the safety and     tolerability of PAT-001 in patients with CI of either the Lamellar or X-Linked subtypes.   "
32217|NCT02864069|"     Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk     for cognitive decline and dementia, with combinations of non-pharmacological interventions     providing greatest promise for impacting cognitive aging. This, paired with limited cognitive     benefits from pharmacological interventions in dementia, has shifted focus to     non-pharmacological interventions administered earlier in the disease course. This     application, therefore, proposes a randomized controlled trial (RCT; 12-week active     intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided     progressive increases in weekly step counts), computer-based cognitive training program     (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on     cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults     with mild cognitive impairment (MCI).   "
32462|NCT02860845|"     The purpose of this study is to determine whether a formula of boric acid and probiotics for     vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis     in comparison to pharmacological reference controls (depending on the suspected diagnosis).   "
32220|NCT02864030|"     On March 17th, 2011, the European Commission issued a marketing authorization valid     throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the     treatment of patients with locally advanced or metastatic breast cancer who have progressed     after at least two chemotherapic regimens for advanced disease.      As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its     safety profile outside clinical trials is warranted.      Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy,     will allow the exclusion from these treatment of those patients harbouring the specific     single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment     discontinuation, the ability to anticipate which patients will experience severe toxicity     could allow for either early intervention or even possibly for prophylactic therapy, or for     selection of the patients to be treated.   "
32221|NCT02864017|"     The main objective of this study is to demonstrate that the only administration of     L-citrulline, can improve immune functions in critically ill patients at high risk of     nosocomial infection.   "
32222|NCT02864004|"     The aim of the study is to assess the use of the apomorphine pump in earlier stages of     Parkinson' Disease (PD), when motor complications have just developed and before patients are     significantly affected in their social and occupational functioning. The investigators     hypothesize that apomorphine pump is superior in terms of positive impact on quality of life     (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance     of severe disabling motor complications thus favoring the maintain of patients' social and     occupational status with a significant positive economic impact of the health system.   "
32223|NCT02863991|"     ONC201 is an orally bioavailable first-in-class small molecule with demonstrated antitumor     activity in preclinical models of difficult-to-treat solid and liquid tumors without     imparting significant toxicity. This is a Phase 1/2 open-label study of ONC201 administered     orally once every week in combination with dexamethasone to patients with relapsed/refractory     multiple myeloma.      Funding Source - FDA OOPD   "
32224|NCT02863978|"     Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is     very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe     impact on neuro-developmental prognostic. The Rennes University Hospital was granted a     specific funding from the European Union in the framework of the Horizon 2020 programme (Call     PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop     the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools     to support decision making in health. Such tools include a new generation of real time     monitoring in neonatology using composite indices made of cardio-respiratory variables,     movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological     data relevant for the creation of the composite indices.   "
32225|NCT02863965|"     The aim of the study is to evaluate the diagnostic value of high definition endoscopy and     optic enhancement in gastric neoplasia.   "
32226|NCT02863952|"     The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to     the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.   "
32227|NCT02863939|"     The aim of this study is to test for an early post-stress cardiac output (CO) change by     impedance cardiography and its relation to the severity and extent of myocardial ischemia and     angiographic coronary disease in subjects undergoing exercise stress testing using a novel     cadmium-zinc-telluride (CZT) SPECT camera.   "
32228|NCT02863926|"     Patients scheduled for below knee amputation (BKA) to receive bone marrow cells (cBMA)     injected IM in the leg proximal to the BKA in the index limb to prevent ischemic wound     complications after surgery.   "
32229|NCT02863913|"     This study will evaluate the safety of PD-1 knockout engineered T cells in treating     metastatic advanced bladder cancer. Blood samples will also be collected for research     purposes.   "
32230|NCT02863900|"     The main objective of our project is to further characterize the deregulation of CE     (Cholesterol Epoxides) metabolism in different moleculars subtypes of BC (BC=Breast Cancer)     (luminal A and B, HER2+ and triple negative). We will study not only the level of expression     of the enzymes involved in this pathway by immuno-histochemistry, all the enzymes involved     were identified in our preclinical work (GSTA1 (Glutathione S-Transferase A1 ), DHCR7, D8D7I,     11βHSD2 (11β-hydroxysteroid dehydrogenase of type 2 )), but also the metabolite rates of CE     (hydrolyses cholesterols-5,6-epoxide ), CT (into cholestane-3β, 5α, 6β triol ), DDA     (Dendrogenin A)and OCDO (6-oxo-cholestan-3β, 5α-diol ). Our preliminary results demonstrate     the feasibility of these dosages. We will also establish whether these deregulations are i)     correlated with different histo-prognostic parameters (pN (N= Node), pT (T= Tumor) , EV,     TIL…) but also clinical ii) an independent prognostic parameter of BC in terms of     disease-free survival, metastasis-free survival and overall survival. The cohort consists of     350 cases of BC, treated between 2009 and 2011 as well as all relevant clinical informations.     In parallel, we will continue our preclinical work by characterizing the targets and     mechanisms of action of OCDO. Our preliminary results indicate that OCDO is a modulator of     the glucocorticoid receptor (GR), which could be target to inhibit this pathway. On the other     hand, we will characterize in the same manner as in human tumors, the deregulations of the CE     metabolism in vitro and in vivo (including xenografts in mice of human tumors, in     collaboration with Roman-Roman S) on a representative panel of BC molecular subtypes,     sensitive or not usually administered in clinical treatment and study the anti-tumor effect     of various anti-OCDO therapies (therapies preventing its production such as Tam (tamoxifen)     or DDA, inhibitor of the enzyme producing OCDO, or an inhibitor of the GR (glucocorticoid     receptor )), alone or in combination with conventional therapies   "
32231|NCT02863887|"     The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits,     increased physical activity, improved blood glucose and cholesterol, and weight related     quality of life in obese African American adults through a sustainable, technology enhanced,     church-based program.   "
32253|NCT02863588|"     Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible     for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may     reactivate without known reasons, causing severe irreversible visual loss. The overall     recurrence rate of OT in Europe is greater than 80% for patients and may range from one     episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce     the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these     immunocompetent patients. These clinical and biological expression changes might be related     to an individual genetic susceptibility of each patient. The advanced analysis of the entire     genome now possible to consider the project.   "
32254|NCT02863575|"     An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental     pain.   "
32232|NCT02863874|"     INTRODUCTION It is estimated that over 80% of women who give vaginal birth will sustain some     form of perineal tear and of these 60-70% will require suturing. It is of great importance     that operators are familiar with the best suturing technique and suture material in order to     minimize possible associated short- and long-term sequelae. There is evidence for suturing     continuously to reduce postoperative pain and superficial dyspareunia, but the choice of     suture-material is still debated. The function of a suture is to close the wound to minimize     the bleeding, the risk for infection and to adapt the wound edges to promote anatomic correct     healing. Infection results in softened wound edges, shirked sutures, pain and dehiscence.     Delayed and/or compromised wound healing is correlated with impaired strength in the affected     tissue. Reported frequency of infection after first and second degree tear is between 1 and     11% where the discrepancy most likely is due to poor registration and follow-up. In 2004     Polyglactin 910 was launched with a new antibacterial coating of Triclosan (VicrylPlus®).     Studies suggest a correlation between the use of VicrylPlus® and a reduction of up to 30% of     surgical site infections (SSI) compared to conventional sutures in a non-colonized wound.      OBJEKTIVE: The primary objective is to compare infection rates and pain intensity when using     Vicryl® versus VicrylPlus® for perineal repair after delivery. Secondly, to show if there is     difference in insufficient wound healing or superficial/deep dyspareunia after one year     between the two groups.      METHODS The participants are randomly allocated to continuously suturing with either Vicryl®     or VicrylPlus®. Sealed identical looking envelopes are prepared and placed in the delivery     room (randomized into blocks of 50, 948 in total) containing randomization number, sutures,     declaration of informed consent and questionnaires. The participants are instructed to fill     in the first questionnaire after 7 days and the second questionnaire after 8 weeks post     partum. After 8 weeks all participants are offered a routine visit to the out-patient     clinic. After one year an internet-based survey will be sent out to the participants. In     case of complains/signs of deficient healing after one year the woman will be offered a     clinical control. Data will be analyzed according to intention to treat.   "
32233|NCT02863861|"     The purpose of this study is to compere between Propofol-Ketamine combination and     Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in     paediatric patients.   "
32234|NCT02863848|"     The main objective of this Pilot study was to assess the beneficial effects of a daily     supplementation with Orafti inulin‐type fructans in 2‐5 year old constipated children The     study is primary aimed to develop a feasibility study to assess the beneficial effect of     inulin‐type fructans in the described population with regard to the adequate criteria for a     larger trial. Secondary objectives are to obtain data about the feasibility of the protocol     (as pilot study). To obtain data useful to perform sample size calculations for a big study     designed specifically to investigate the beneficial effect of inulin‐type fructans in the     treatment of constipated children.      Study design and subjects: Double‐blind, randomized, placebo‐controlled parallel group trial;     where 2‐5 year‐old constipated children received inulin‐type fructans or the same amount of     placebo (maltodextrin) during 6 weeks. The study protocol was approved by the local Ethical     Committees.      Outcomes: primary outcome was stool consistency. Secondary outcomes were: stool frequency,     gastrointestinal symptoms (abdominal pain and pain during defecation), additional medication     required (yes/no), and colonic transit time. Stool samples at baseline, end of intervention     and after follow‐up were obtained in order to be analysed to know about the microbiota.     Dietary intake was also recorded at baseline, end of intervention and after follow-up.      Principal subject inclusion criteria: Subjects were recruited if fulfil the Rome III     constipation criteria (Mainly hard stools plus stool retention, or pain, or low frequency).     Principal subject exclusion criteria: Age under 2 or over 5 years, diapers use, use of     laxative during the study and 2 weeks before, use of pre‐ probiotics or antibiotics during     the study and 4 weeks before, organic causes of defecation disorders, other metabolic or     renal abnormalities or mental retardation, no parent's command of any local language.   "
32235|NCT02863835|"     Electrical impedance tomography (EIT) is non-invasive and provides functional imaging of the     lung and it could be a useful tool to diagnose chronic lung allograft dysfunction (CLAD) and     specially Bronchiolitis Obliterans Syndrome (BOS). Hence, for this study, the investigators     aim to show that EIT would provide an accurate diagnostic CLAD with an ability to to     distinguish BOS from Restrictive Allograft Syndrome (RAS) and to stage BOS accurately when     compared to FEV1 the current gold standard. The investigators are also aiming to provide     physiological data in lung transplant recipients with chronic rejection.   "
32236|NCT02863822|"     The purpose of this study is to evaluate the effectiveness of the low fermentable     oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The     investigators will compare education in the low FODMAP diet to a standard healthy diet for     improving symptoms in FD.   "
32237|NCT02863809|"     This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled     clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the     keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis     implantation but because of a history of corneal melts or autoimmune diseases are not     candidate for a traditional corneal transplant.   "
32238|NCT02863783|"     RATIONALE: Pancreas tumor localization makes minimally invasive surgical resection of     pancreas tumors very challenging. Recently, an endoscopic ultrasound needle system has been     developed which enables fiducial coils to be placed at the precise site of biopsy.      INTERVENTION: At time of EUS guided biopsy the fine needle fiducial device will be used to     place fiducials in the tumor. During surgery we will assess whether it improves tumor     visualization.      OBJECTIVES: We aim to determine the feasibility to use EUS guided fiducials placement to mark     pancreas tumors in 20 patients and to assess whether the fiducials impact tumor visualization     during pancreas surgery.      STUDY POPULATION: Patients with pancreas adenocarcinoma or neuroendocrine lesions.      STUDY ENDPOINTS: The main outcome will be to assess whether the coil may be successfully     placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and     ANALYSIS: Patients will be assessed at the time of EUS and surgery. This is a pilot analysis     with the intention to assess feasibility and to gather data to power larger trials.   "
32239|NCT02863770|"     RATIONALE: Endoscopic Ultrasound (EUS) is the leading method to evaluate the pancreas but     there may be difficulty characterizing small lesions, tumors which are not adenocarcinomas     and neoplasia in the setting of pancreatitis.      INTERVENTION: The innovation in this project will be the addition of intravenous contrast to     standard EUS examination if the pancreas.      PURPOSE: The aim is to determine if contrast enhances the ability of EUS to accurately     diagnose lesions and target biopsies, and to define the quantitative features of this method.      STUDY POPULATION:The population will include patients with pancreas cysts, masses, and     inflammation presenting for EUS as part of standard clinical care.      METHODOLOGY: This will be a prospective tandem trial involving conventional EUS, followed by     EUS with contrast, followed by subsequent quantitative processing of contrast EUS imaging.      ENDOINTS:Study endpoints will include the yield contrast EUS to evaluate pancreas cysts,     masses, and inflammation. The impact of contrast EUS to better target the FNA of the chosen     lesion will be assessed. Intra and interobserver variability will be assessed by comparing     conventional EUS and contrast EUS of each case in a random order (intraobserver agreement)     and among a group of blinded endosonographers (interobserver agreement).   "
32240|NCT02863757|"     The purpose of this study is to determine the disease progression in CHB/NAFLD compared with     CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma     (HCC).   "
32241|NCT02863744|"     Assessment of wound healing progression after surgery is important. Currently blunt surrogate     markers such as probing is used. Limitation of these markers is that it represents the     history of healing and not the ongoing activity. As hallmark of healing is collagen     remodeling, it is of interest to study the cytokine profile that relates to wound healing.     Such knowledge may potentially lead to new diagnostic strategies to study wound healing in a     better way reflecting the healing phenotype. Understanding wound healing at molecular level     provides an in depth basis to develop treatment strategies that can prevent delayed healing.2     As recommended by Consensus Report of 10th European workshop on periodontology that, there is     a need for more studies at cellular level to identify cytokine, chemokine, and intracellular     signaling networks for better regenerative approaches10, the present clinical trial was     designed.      On account of a considerable lacunae in this area of periodontal research, this study is     planned to assess the MMP-8 levels during the post-op healing following CAF+SCTG surgery for     recession coverage and to better identify the mechanism involved in wound healing. This     information can be used to prevent the normal surgical wound from altered healing experience.   "
32242|NCT02863731|"     Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes,     several types of cancer and all-cause mortality. In combination with static and awkward     postures, the prevalence of musculoskeletal diseases can increase further. Although the     implementation of sit-to-stand or active workstations can help to reduce sitting time,     improve physical activity at work and promote health benefits, it might also lead to changes     in cognitive functions such as productivity. The purpose of this study is to evaluate the     short-term effect of alternating working postures on cognitive performance for healthy     people.   "
32243|NCT02863718|"     This is a prospective, multicenter, randomized, placebo-controlled, double-blind phase III     study that compares the efficacy and safety of oral ibrutinib in previously untreated Binet     stage A CLL patients without treatment indication according to iwCLL guidelines but risk of     early disease progression.      For event-free survival (EFS), an improvement from 24 months for untreated intermediate or     (very) high risk CLL to 48 months for subjects treated with ibrutinib is considered     clinically relevant. Ibrutinib / placebo is administered continuously orally until     symptomatic disease progression, unacceptable toxicity, or voluntary treatment withdrawal,     whichever occurs first.   "
32244|NCT02863705|"     The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN®     (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine     tartrate/timolol malate) and also in patients who require additional IOP lowering with     LUMIGAN® (bimatoprost) 0.01%.   "
32245|NCT02863692|"     Long term follow-up of patients with chronic lymphocytic leukemia (CLL), B-prolymphocytic     leukemia (B-PLL), T-cell prolymphocytic leukemia (T-PLL), Small lymphocytic lymphoma (SLL),     T/Natural Killer large granular lymphocyte leukemia (T or NK-LGL), Hairy cell leukemia (HCL)     and Richter's transformation   "
32246|NCT02863679|"     This study was taken out to assess the postoperative analgesic efficacy of tetracaine     hydrochloride gel in patients with intrauterine adhesion treating with intrauterine     balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel     group and control group.   "
32247|NCT02863666|"     Prospective observational clinical study to verify an algorithm used to predict     cardiopulmonary events in patients presenting to the emergency department.   "
32248|NCT02863653|"     Objective: To evaluate what factors contribute to social participation restrictions in     subjects with Rheumatoid Arthritis (RA), considering the model International Classification     of Functioning (ICF).      Methods: Cross-sectional study with 81 individuals with Rheumatoid Arthritis, using     instruments to measure two constructs of component social participation.   "
32249|NCT02863640|"     Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among     the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE)     and the external segments of the retinal photoreceptors, plays a crucial role in this     pathology. A recent epidemiologic study in the US, unpublished yet, has shown that patients     treated with the L-DOPA, developed only later an ARMD when compared to the untreated     patients.      The L-Dopa is an endogenous ligand of the GPR43 receptor, located on the RPE's cell's apical     pole.      This receptor, via several intracellular mechanisms, regulates the cell's exosomal and     endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases     significantly the RPE's exosome release.      The contents of the exosomes is still uncertain, however in addition to their signalization     role, it seems they transport pro-inflammatory components, possibly helping the cellular     recruitment due to the mononuclear phagocytic systems, particularly toxic for the     photoreceptors.      The aim of this study is to validate the hypothesis stating that he L-DOPA would play a     protective role against age related macular degeneration.   "
32250|NCT02863627|"     This study will evaluate the course of care of newborns, to understand why some newborns have     improper care pathways, particularly as regards the first medical consultation at the exit of     motherhood. It is also to organize a better quality care network to hospital discharge to     avoid unnecessary use of pediatric emergencies, which represents a real public health     problem.   "
32251|NCT02863614|"     The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam     reduce the pain associated with endometrial scratching/injury.   "
32252|NCT02863601|"     The primary purpose of this study is to determine whether buprenorphine and metabolite     exposure (reflected as the dose-adjusted plasma concentration x time curve [AUC]) differs     during pregnancy and between pregnancy and the postpartum state.The study will define the     pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing     based on objective, physiological parameters of satiety. The study will also determine which     maternal, placental or fetal factors impact the risk of Neonatal Abstinence Syndrome (NAS)     and will define neonatal exposure to buprenorphine through breast milk.   "
32278|NCT02863354|"     The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept     injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal     non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR) primarily     assessed through retinal capillary non-perfusion.   "
32255|NCT02863562|"     Soccer is a sport that attracts many participants and leads to a substantial number of     injuries, especially of the ankle. Enhancement of functional joint stability by kinesio     taping proprioceptive training may be important both in prevention and rehabilitation of     ankle injuries. The main aim of this study was to determine the effect of kinesio taping and     proprioceptive exercises on parameters related to ankle stability, such as the injury     incidence, pain, static or dynamic stability and flexibility, in amateur soccer players     training 3 times a week.   "
32256|NCT02863549|"     The aim of this study was to investigate the procedural feasibility and 30-day results of     transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in     selected, highly symptomatic patients with severe tricuspid regurgitation (TR).   "
32257|NCT02863536|"     The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months,     clinical study.      Interventional, non-controlled, multicenter trial with a prospective design on one cohort of     patients   "
32258|NCT02863523|"     The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a     unique collaborative, stepped-care intervention for patients with uncontrolled Type 2     diabetes and co-morbid distress and/or depression.   "
32259|NCT02863510|"     A pilot, single-center, prospective, interventional study. The objective is to demonstrate     that catheter-based renal denervation using carbon dioxide renal angiography in patients with     moderate to severe chronic kidney disease can be performed for treatment of uncontrolled     hypertension.   "
32260|NCT02863497|"     This study aims to determine if there is an impact on sexual distress using mindfulness-based     sex therapy (MBST) in addition to standard urogynecologic care, in women with both urinary     incontinence (UI) and sexual dysfunction.   "
32261|NCT02863484|"     The blood loss will be compared in middle fossa meningiomas which will receive pealing of the     outer layer of the lateral wall of the cavernous sinus and those which will not revive     pealing before the dura is opened   "
32262|NCT02863471|"     In patients with peritoneal metastases of colorectal cancer could be a radical removal of all     tumor foci a significantly improved survival compared to a sole systemic chemotherapy are     additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC).   "
32263|NCT02863458|"     The study aims to comprehensively analyze data from a large and unselected older AML     population in the US, both treated and untreated. These data will widen understanding of     treatment decisions for the older Acute Myeloid Leukemia (AML) population. Through use of the     SEER-Medicare Registry, the effectiveness and impact of HMA treatments as well as the     effectiveness of lenalidomide will be studied.   "
32265|NCT02862392|"     The hypothesis of this study is that progressive AIS is characterized by a disorder of     orthostatic postural control. The analysis and the treatment of posturographic signal on     computerized integrate force plates, coupled to clinical and radiographic examinations, could     highlight predictive and reliable factors at the moment of diagnosis. Thus, it could help the     clinician in his therapeutic approach, based on the postural control improvement     (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by     corset). This method is non-invasive, without side effects, fast and achievable in routine     care at the moment of the diagnosis of AIS.   "
32266|NCT02862379|"     The risk of falling affects more than one third of people over 65 years old and over 50% of     persons over 80 years. These falls have important consequences for the autonomy of the     elderly patient and also increase the risk of sequelae and death.      The goal of this study is to evaluate a personalized rehabilitation program for elderly     patients that fall for the first time and to measure the impact on the fear of falling of     these patients. This intervention is a home-based program combining exercises, home     modifications and education on fall risk factors.   "
32267|NCT02862366|"     Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such     as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have     a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant     increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation     and blood hyperviscosity, resulting from these diseases, fail to account for these     thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic     drug treatment.      These last years, cellular microparticles (MPs) have been shown to play a major role in     thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells,     platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller     than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as     support for the coagulation factors. Increase in the plasma concentration of procoagulant     platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary     syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that     platelet microparticles are involved in the hypercoagulability of MPNs patients.   "
32279|NCT02863341|"     This is a multi-centre study in Singapore nursing homes, investigating the factors that     affecting deprescribing, and if a team-care based deprescribing standard practice gives     superior health and pharmacoeconomic outcomes over current medication review practice.   "
32280|NCT02863328|"     This trial is conducted globally. The aim of this trial is to investigate Efficacy and Safety     of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.   "
32281|NCT02863315|"     The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct     current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who     have chronic neuropathic pain.   "
32765|NCT02856880|"     The aim of this exploratory study is to assess the ability of two test toothpastes containing     0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate     (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque     bacteria using the plaque glycolysis regrowth model (PGRM).   "
32299|NCT02863081|"     Select Specialty, a national network of more than 100 LTACHs across the United States, has     expressed the desire to adopt the ABCDEF bundle as a standard of care for its patients. As     part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement     project in one of its local hospitals. The overall purpose of this before-after study is to     study prospectively the process and effects of implementing the ABCDEF bundle into the     everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting.   "
32268|NCT02862353|"     The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from     a peripheral destruction of platelets in the presence of the drug only. They usually involve     immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein     or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The     most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory     drugs or anticonvulsants but the list is not exhaustive.      in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM     is suspected but the offending drug is difficult to identify in generally poly-medicated     patients.      Several drugs may be suspected and the clinician uses biology for rapid assistance to the     de-prescription and reduces unnecessary therapeutic substitutions in an always difficult     clinical situation.      The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a     biological test of thrombocytopenia induction in the presence of the drug and the patient's     serum that is to say its antibodies and complement fractions with cytometry reading flow.     This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in     hospital laboratories. But this test must be validated on well-documented clinical cases.      The purpose of this pilot project is to validate the technical and assess the clinical     specificity of the test TITIM for hard imputability drugs validated by a committee of experts     combining a posteriori of clinical and biological criteria of routine.   "
32269|NCT02862340|"     Autism, ranked among the '' pervasive developmental disorders' (ASD), is characterized by     disturbances in the areas of reciprocal social interaction, communication and behavior,     interests and activities restricted, repetitive. Various studies indicate that autistic     disorder is subjected to a genetic predisposition, most likely polygenic and heterogeneous.     However, no major gene responsible for this disorder has yet been identified. Given the link     between the Fragile X syndrome (the most common form of mental retardation (MR) hereditary)     and autistic behavior, it seems interesting to look, also, a possible link to the molecular     level. Among the proteins interacting with FMRP (absent protein in fragile X patients), the     investigators were interested to CYFIP1, protein encoded by the gene CYFIP1 appears to be a     good candidate gene involved in the RM and autism by its chromosomal position and function.     As FMR1, CYFIP1 is expressed in the brain cortex, hippocampus and Purkinje cells of the     cerebellum. This protein co-localizes and interacts with Rac and FMRP, which are both     involved in neurogenesis and cognitive development. In humans, the gene encoding CYFIP1 is     located in the 15q11-q13. Now, the only autosomal abnormalities most frequently observed in     autism are those involving the proximal 15q region, including duplications or 15q11-q13     triplications interstitial, of maternal origin.      These data suggest that an / or more autism genes responsible are probably present in the     15q11-q13 chromosomal region, although no gene has yet been identified. Thus, the study of     the role of CYFIP1 gene in patients with autism spectrum disorders would most likely     contributory.      The investigators wish to study the involvement of the 15q11-q13 chromosomal region and     CYFIP1 gene in autistic disorder in a hundred patients from the Autism Resource Centre (ARC)     Nice PACA antenna, over a two year period.      The diagnosis and assessment report of children likely to be included in this study will be     conducted at ARC Nice. Balance sheets are made according to the recommendations of the High     Authority of Health for diagnosis of infantile autism and PDD. These children are then sent     to the Genetic Consultation Nice Hospital where an analysis of the background and a specific     morphological examination will be realized..   "
32270|NCT02862327|"     Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged     postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after     ultrasound guided axillary brachial plexus block   "
32271|NCT02862314|"     There is actually no consensus in place defining for which patients with suspected inhalation     pneumonia antibiotic treatment should be initiated and what the duration of this antibiotic     treatment should be.      This absence of recommendations results in excessive use of antibiotics, in emergence of     multi-resistant strains and increase of costs. Several studies have been performed     investigating antibiotic treatment based on procalcitonin values and have demonstrated a     decreased use of antibiotics without change in mortality rates, in duration of     hospitalization, in occurrence of super-infections or in infection relapse rate. Of the     studies performed in an intensive care setting, none has specifically studied inhalation     pneumonia.      The objective of this study is to determine whether use of a decisional algorithm based on     procalcitonin values allows reducing antibiotics exposure in patients who are intubated     because of coma in comparison with standard care according to actual guidelines and clinical     experience with respect to ventilator-acquired pneumonia.      The study has a prospective, multi-centre, comparative, randomized, open design. It is a     superiority study, with as primary parameter the duration of antibiotic therapy during the     first 15 days after admission in the intensive care unit (ICU).      Patients can be included in this study if they are intubated for coma (Glasgow Coma Scale     (GCS) ≤ 8) within 48 hours following admission to the hospital and with a foreseen duration     of ventilation exceeding 48 hours.      There will be two treatment groups, stratified by centre and randomised in blocs of 4: one     group for which treatment initiation and discontinuation will be guided by a     procalcitonin-based decisional algorithm and a control group to whom antibiotics will be     administered according to the standard protocols of each participating centre.      Based on an estimated duration of antibiotic treatment of 6.2 days, a risk -significance α     level- of 5%, a power of 90% and a reduction of antibiotic treatment duration of 25% in the     treatment arm guided by procalcitonin values, the number of patients to be included is 83 per     treatment arm. Taking into account a loss of 10% for patients lost to follow-up, 166 patients     should be included.   "
32272|NCT02862301|"     The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral     blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group) and     healthy controls (control group).   "
32273|NCT02863419|"     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety     of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes     Mellitus.   "
32274|NCT02863406|"     Comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients     suffering from sarcoidosis.      Blind analysis of bronchoalveolar lavage with Optical Microscopy, Transmission Electron     Microscopy and MicroAnalysis.      For patients, comparison of bronchoalveolar lavage, pathological examination of biopsies     (Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis) and specific     Professional and environmental questionnary.      Healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco     consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year,     smoking more than 10 pack-year)   "
32276|NCT02863380|"     The investigators hypothesize that personalizing the rTMS targets using functional MRI will     increase its efficacy. The most dysfunctional regions or the most dysfunctional network will     be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS     procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over     trial.      In this pilot study the primary outcome measure will be the correction of the MRI anomalies.     Symptoms reduction and the proportion of remitters will be secondary outcome measurements.   "
32277|NCT02863367|"     Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in     advanced metastatic pancreatic cancer.   "
32496|NCT02860403|"     Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional     rehabilitation and cerebral plasticity through the qualitative and quantitative mental     practice approach. For this, the investigators will use magnetoencephalography (MEG) but also     physiological and behavioral indicators developed by the Laboratoire de la Performance     Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.   "
32282|NCT02863302|"     The aim of this study is to test a complementary therapy intervention (reflexology) that will     assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute     myeloid leukemia. within the context of conventional medical care. Quality of life will be     assessed via intermediate indicators: 1) physical indicators (greater physical functioning,     lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and     lower depressive symptomology); by a specific questionnaire. 3) chemotherapy side effects     associated with the digestive system.   "
32283|NCT02863289|"     To date, the clinical benefits and harms of surgical intervention in proximal humerus     fractures in children remain debatable. The practical question raised by orthopaedic surgeons     is: for children and adolescent, are the clinical and radiological outcomes after     non-operative management as equivalent as after surgical management for proximal humerus     fractures? The investigators' hypothesis is that due to the healing potential of the proximal     humerus, the outcome from this fracture is usually excellent.      The investigators have applied for Caldicott approval to identify a cohort of eligible     patient from NHS Tayside's radiography service. With the community health index (CHI) number,     the investigators can review all shoulder X-rays performed in children and adolescents, aged     from 10 to 18-year-old in NHS Tayside, from 2008 to 2015. The Caldicott approval also allowed     the investigators to obtain clinical communication from the Clinical Portal (electronic     summary healthcare records). The investigators will then conduct mail questionnaires, based     on the Upper Extremities Functional Index (UEFI). The investigators will send out invitation     letter with participation information and the UEFI questionnaires to the eligible patients;     with return postages. If no response within 2 weeks, the investigators will send out 1     further reminder. If no further response, the patient will be excluded from the study.   "
32284|NCT02863276|"     Background Surgical injury provokes a stress response. These pathways mediated by stress     hormones and cytokines cause a catabolic state. The loss of body cell mass may result in     prolonged convalescence and increased morbidity. Protein catabolism after colorectal surgery     is even more increased in patients with type 2 diabetes mellitus. Epidural blockade, by     reducing the intensity of the catabolic response, improves substrate utilization after     surgery in non-diabetic patients. This effect is even more pronounced in diabetic patients     receiving amino acids.      The aim of the study is to explore the effect of two different protocols to manage blood     glucose control on glucose and protein metabolism in patients with type 2 diabetes mellitus     undergoing colon surgery and receiving epidural analgesia and perioperative feeding with     amino acids. The following hypotheses are tested:        1. Tight perioperative blood glucose control with intensified insulin therapy compared to          standard blood glucose control in presence of general anesthesia with epidural analgesia          and amino acid infusion would reduce endogenous glucose production and leucine          oxidation.        2. Tight blood glucose control and perioperative infusion of amino acids induce a more          positive protein balance compared to standard blood glucose control by better oxidative          glucose utilization and redirecting amino acids from oxidative to synthetic pathways.      Material and Methods A total of 20 patients with diabetes mellitus type 2 undergoing elective     colorectal surgery will be admitted to the study. Patients will be randomly assigned to     receive standard blood glucose control (blood glucose target <10 mmol*l-1; control group;     cytotoxic T lymphocyte (CTL) group, n=8) or to receive tight blood glucose control with     intensified insulin therapy (blood glucose target<6 mmol*l-1; intensified insulin group; II     group, n=8). All patients will receive general anesthesia and an epidural catheter for     perioperative analgesia. During surgery (intraoperative state) and immediately after surgery     (postoperative state) when receiving an amino acid infusion protein and glucose kinetics will     be assessed using a stable isotope technique with L-[1-13C]leucine and [6,6-2H2]glucose and     circulating concentrations of glucose, glucagon, insulin and cortisol will be measured. The     primary endpoints of the study will be protein balance. Sample size is set to ensure at least     80% power at a significance level of 0.05.   "
32285|NCT02863263|"     This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane     foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment     is 20 patients, with 10 patients per arm.   "
32286|NCT02863250|"     Severe and unstopped blood loss can occur for a number of different reasons including after a     serious injury, delivery of a baby and following other medical and surgical emergencies. The     investigators understanding of how to best treat people with serious bleeding is still     incomplete, with many questions remaining. These include questions regarding how many people     have serious bleeding events, what happens to them and the best way to treat them.      The Massive Transfusion Registry (MTR) is a register of patients who have experienced major     blood loss that required a massive transfusion in any clinical setting.      The MTR uses electronic data extraction and data linkage methodologies. Pre-existing clinical     data from hospital data sources, including Laboratory Information Systems (for transfusion     history and laboratory results) and Health Information Services databases (for Patient     demographics and admission data), are electronically extracted by staff employed at the     participating hospitals. The data is then sent to the MTR Research Team, located at Monash     University, where it is then linked, analysed and stored.      The establishment of a Massive Transfusion Registry will be a unique and important resource     for clinicians in Australia, New Zealand and internationally, for Blood Services and for the     broader community. It will provide valuable observational data regarding the types and     frequency of conditions associated with critical bleeding requiring massive transfusion, the     use of blood component therapy (i.e. ratios and quantities of different types of red cell to     non- red cell components) and patient outcomes.   "
32287|NCT02863237|"     Brian injured patients are predisposed to various complications related to mechanical     ventilation. Appropriate decision making of the weaning is crucial and validated predictive     parameters are desirable. In present study, the investigators aim to a) validate the     electrical activity of diaphragm (EAdi) derived parameters, and b) evaluate the traditional     predictive parameters in weaning prediction in brain injured patients.   "
32288|NCT02863224|"     Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact     pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is     advancing age. The rate of ageing is not the same in all age matched individuals. The concept     of accelerated ageing suggests that the presence of a number of specific genetic,     environmental or systemic risk factors may cumulate to accelerate the ageing process in some     individuals and lead to the development of age-related disease. Understanding the factors     that influence accelerated ageing is vital.      Advanced glycation end products (AGEs) are a complex group of compounds that are naturally     formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the     body where they adversely affect structure and function. Circulating AGE levels can be     influenced by oxidative stress levels and dietary intake. Recent research has found that     sustained exposure to high levels of circulating AGEs could be a major factor in the     development of a number of chronic age-related degenerative disorders, including POAG.      To date there have been few clinical studies that have been able to non-invasively explore     the association between AGE levels and the development and progression of glaucomatous optic     neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary     intake make to total tissue AGE levels in such patients. Furthermore little is understood     about the relationship between AGE levels and retinal vascular function, a parameter known to     be altered in GON that also could be influenced by AGE levels.      The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with     parameters of retinal vascular function, oxidative stress, dietary intake and the presence of     GON. Establishing this association could increase our understanding of the pathogenesis of     GON and allow a new biomarker for accelerated ocular ageing to be realised   "
39592|NCT02767401|"     The purpose of this study is to investigate the effect of percutaneous coronary intervention     (PCI) on myocardial viability in coronary artery disease patients with single coronary total     occlusion (CTO) lesions.   "
32289|NCT02863211|"     Efforts to identify individuals at a higher risk for adverse cardiovascular outcomes focus on     traditional risk factors, such as age, gender, smoking status, blood pressure, and     cholesterol; however, this approach does not directly assess cardiovascular function and     underestimates the risk of experiencing adverse cardiovascular outcomes in women. This     prospective, observational trial will examine the ability of the Heart Attack Prevention     Program for You (HAPPY Hearts) screening protocol, a series of non-invasive procedures to     identify middle-aged and older women who are at elevated risk for experiencing an adverse     cardiovascular event in the five-year period after screening. The predictive value of the     HAPPY Hearts protocol will also be compared to the Framingham Risk Score to determine if one     method has better sensitivity for estimating risk for an adverse cardiovascular outcome.   "
32290|NCT02863198|"     One hundred and twenty women with unexplained infertility were included in the study. Divided     randomly into two groups:      Group I: (60 patients): (control group)      Group II (60 patients): (study group)      All the patients received (CC) and human menopausal gonadotropin. On day 5 of the cycle,     Doppler examination was performed to all patients. Also on day 5, but only for group (II)     patients, local endometrial injury was performed. Doppler studies was repeated, for all our     patients, on the same day of prescribing human chorionic gonadotropin   "
32291|NCT02863185|"     Patients with chronic kidney disease (CKD) are high risk for death and cardiac disease is the     major cause of death. CKD patients commonly have traditional risk factors for coronary artery     disease, such as age, gender, hypertension, cigarette smoking, and dyslipidemia. Previous     studies have reported that reducing cholesterol levels is associated with reducing morbidity     and mortality from atherosclerosis. In particular, pharmacologic treatment using statin has     been decreased the risk of adverse cardiovascular events in CKD population. Therefore,     guidelines recommended the use of statin in CKD patients. On the other hands, niacin or     fibrates is not recommended concomitantly with statins in patients with CKD because of     increased risk of adverse events. In addition, recent study has reported that there was no     incremental clinical benefit from the addition of niacin to statin therapy, in further     decreasing the incidence of major cardiac events.      Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in     patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be     explained by anti-inflammatory, anti-oxidative, or anti-thrombic effects. In addition,     omega-3 FA modulates cell membrane receptors and affects signal transduction and eicosanoid     metabolism. The erythrocyte membrane content of FA has been shown to correlated with the FA     content of the myocardium. The risk of cardiovascular disease is significantly reduced in     patients with high omega-3 FA, such as eicosapentanoic acid or docosahexaenoic acid (DHA), in     the erythrocyte membrane. In contrast, high levels of erythrocyte membrane total trans-FA,     trans-oleic acid, and arachidonic acid (AA) are associated with an increased risk of     cardiovascular disease. Erythrocyte membrane monounsaturated FA (MUFA) content, including     oleic acid, is significantly higher in patients with acute coronary syndrome than control     subjects. The erythrocyte membrane oleic acid content was also higher in dialysis patients     who have high risks of cardiovascular disease compared to control subjects. Therefore, the     modification of erythrocyte membrane FA content is very important with respect to     cardiovascular disease. In a previous study, erythrocyte membrane omega-3 FA was shown to be     increased and the MUFA content was decreased after omega-3 FA supplementation in HD patients.     However, there are no reports about the effect of statin on the erythrocyte membrane FA     composition in CKD. Recent study has reported that those with pitavastatin 4mg were decreased     DHA to AA ratio, but those with pravastatin 20 mg were not change the DHA to AA ratio in     patient with CAD. Statin may have important role on the modulation of erythrocyte membrane     FA. In this study, the investigators hypothesized that pitavastatin supplementation can     modify erythrocyte membrane FA content, including MUFA and oleic acid, in CKD patients. In     addition, the investigators evaluated the effect of pitavastatin on adiponectin and glucose     level in CKD patients.   "
32292|NCT02863172|"     Objectives:        1. To examine the variations in clinical features, survival outcomes, family history, and          health behavior among proband patients who are known or suspected to have a hereditary          colorectal cancer syndrome        2. To compare the clinical features, survival outcomes, and health behavior of the proband          vs. his/her family members who may or may not be affected by the hereditary colorectal          cancer syndrome        3. To explore for correlations between germline genetic variations in both the probands and          family members with observed variations in the overall disease phenotype across probands          and kindreds, within a given syndrome. Disease phenotype is defined to include: (1)          clinicopathologic features including patient demographics and oncologic outcomes; (2)          clinical manifestations of disease including the timing, spectrum and severity of CRC          and extracolonic cancers. Genetic variations may include the specific codon mutated, the          type of mutation and sequence alteration (e.g. nonsence, missence etc), chromosomal/gene          copy number changes, and gene polymorphisms.        4. To explore for correlations between germline genetic variations in both the probands and          family members with observed variations in somatic CRC tumor biology, including tumor          pathology and other tumor molecular markers   "
32293|NCT02863159|"     The objective of this study is to evaluate the uncorrected binocular distance, intermediate,     and near visual acuities, and assess patient's spectacle independence and satisfaction in     individuals undergoing bilateral cataract extraction that have received two different arms of     near add design IOLs of the same diffractive multifocal model.   "
32294|NCT02863146|"     HALACAP-1406 is a prospective single-centre non-interventional study assessing the     refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®)     in the conditions of use specified in its marketing authorization. Eribulin will be used     alone for the treatment of the patients having a locally advanced or metastatic breast cancer     which have progressed after at least 1 chemotherapy regimen for their advanced stage.   "
32295|NCT02863133|"     The study is a prospective, multicenter, multinational study to assess the safety and     performance of the Easyx (trade name) Antia Liquid Embolic during embolization of     intracranial malformations and fistulas. The clinical trial will include patients already     scheduled for neuroradiological interventions. It is estimated that up to 8 sites will be     required to collect the safety and performance data of the study material. Up to 65 patients     will be enrolled in the study to achieve 53 evaluable patients. Each study centre will be     required to treat 5 patients with a Dural arteriovenous fistula - DAVF before they can treat     brain arteriovenous malformations - AVMs or brain tumours. Only experienced neuroradiologists     will be invited to participate in this study.   "
32296|NCT02863120|"     This study is being done to evaluate the outcomes of patients undergoing total knee     replacement with two different methods of local pain control:shots of liposomal bupivacaine,     a long acting anesthetic, directly into the knee during surgery or anesthetic delivered     continuously to the adductor canal to provide long term pain relief. The goal is to try to     find a standard protocol that provides the greatest pain relief for patients undergoing total     knee replacement.   "
32297|NCT02863107|"     The goal of this laboratory research study is to learn more about genetic factors that may     influence the risk for developing colorectal cancer at a young age.   "
32298|NCT02863094|"     To investigate the treatment effect of continuous transcranial magnetic stimulation on     schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by     functional MRI   "
41220|NCT02746068|"     This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the     efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone     marrow lesions.   "
32300|NCT02863068|"     The investigators propose a Phase II study, prospective and placebo controlled, of a topical     cream containing sodium nitrite compared to the current standard of care. Sodium nitrite is a     local donor of nitric oxide, which is known to improve blood flow and decrease bacterial load     in the ulcer bed. The primary objectives are to evaluate the safety of topical sodium nitrite     cream treatment in patients with sickle cell disease and chronic leg ulcers and to determine     its effectiveness in accelerating the healing process and decreasing the pain associated with     ulceration.      Potential benefit will be a durable resolution or improvement of the leg ulcer and its     associated pain. Possible side effects include decreased blood pressure and     methemoglobinemia, secondary to sodium nitrite absorption through the ulcerated skin.   "
32301|NCT02863055|"     This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with     unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A:     nintedanib and arm B:placebo   "
32302|NCT02863042|"     The investigator hypothesizes that primary acute ankle deltoid ligament repair can help     restore ankle radiographic congruity and functional outcomes.   "
32303|NCT02863029|"     New studies are revealing how a high-fat diet could be making the cells of the intestinal     lining more likely to become cancerous. The investigators would like to study how obesity     influences growth of intestinal stem cells, which could then trigger intestinal tumors.      The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants     from each of two different BMI categories: 20-25 and 35 & above), who will be asked to     provide blood, stool, & urine samples, undergo a flexible sigmoidoscopy, and complete food     frequency questionnaires   "
32304|NCT02863016|"     The aim of this study was to evaluate the effect and timing of action on the inflammatory     state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online     postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate     ) in the medium term. In addition, the study will evaluate other parameters of efficiency     dialysis, cardiovascular stability, the safety of the concentrate with regard to bone     metabolism and vessel calcification in the medium term.   "
32305|NCT02863003|"     Retrospective and prospective cohort of patients with germ cell tumor in treatment.   "
32306|NCT02862990|"     To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of     loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.   "
32307|NCT02862977|"     The purpose of this study is to evaluate the safety and efficacy of an association with one     anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory     plus caffeine in the treatment of osteomuscular pain in adults.   "
32308|NCT02862964|"     Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are     only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This     device uses sound waves to create pictures of the spine in three dimensions. This may allow     the physician to view the spine in more detail for procedures such as spinal anesthesia and     other diagnostic procedures.      The investigators aim to assess the benefit of using the Accuro versus traditional landmark     palpation technique to determine accurate spinal level for procedures. Patients who undergo     interventional pain procedure per standard care under fluoroscopy and require the presence of     an anesthesia provider at the UVA Pain Management Clinic will be approached for enrollment.      Anesthesia Providers will first identify the L4/L5 space using the traditional technique of     palpating the iliac crests to estimate spinal level, which will be marked with a single dot     from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5     interspace and mark this point with two dots. Participants will then be taken into the     fluoroscopy suite for their scheduled procedure. Since the skin marks will not show up on     fluoroscopy, and metal instrument will be laid on the skin at the interspace or interspaces     that were marked using the palpation and Accuro techniques. The anesthesiology attending     provider in the fluoroscopy suite will then confirm the true interspace position of these     marks under fluoroscopy. It will then be recorded how many spaces off the palpation and     Accuro techniques are from the intended L4/L5 level.   "
32309|NCT02862951|"     The specific aim is to attempt to quantify the amount and efficiency of sleep that     parturients receive after placement of labor epidural analgesia.   "
32310|NCT02862938|"     This is a randomized, sham controlled, masked clinical trial of 60 study participants with     glaucoma. Participants with a qualifying study eye will be randomized after screening and     baseline evaluations to receive the NT-501 encapsulated cell therapy (ECT) implant or a sham     surgery (control arm), and no explant will be required.      An examination for safety will occur one day and one week following implant and periodically     thereafter for 24 months post-implant. Based on the primary analysis of data at 6 months,     patients in the control arm may be offered the NT-501 ECT implant at the 12 month time point.   "
32311|NCT02862925|"     This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian     Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the     intermittent auscultation protocols at KCMC, and to validate whether or not a handheld     Doppler device can perform the fetal scalp stimulation test accurately.   "
32312|NCT02862912|"     This study aims to determine whether or not spinal anesthesia with the local anesthetic drug,     chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in     faster discharge from the post-anesthesia care unit after surgery.   "
32414|NCT02861469|"     This qualitative study aimed to describe and understand the factors leading to the admission     in emergency unit of patients coming from their home, in an end of life situation.      This study was conducted in the university hospital of Besançon, France. Semi-structured     interviews were conducted with general practitioners and family members in order to     understand the factors leading, from their points of view, to the admission in emergency unit     whereas this hospitalization wasn't necessary.   "
32346|NCT02862470|"     The investigators expected to enroll 30 patients with papillary, follicular or anaplastic     thyroid cancer, and collect their urine samples before operation, immediately after     operation, post-operative 3, 6 12 months. The investigators will analyze the urine exosomal     proteins and probable biological markers. The investigators hope to find the prognostic     biological markers via this prospective study. The investigators further hope to find newly     therapeutic mechanism and medications for such patients with poorly-differentiated or     anaplastic thyroid cancer.   "
32313|NCT02862899|"     The investigator will study the possibility of in situ heating of the liquid containing the     chemotherapy, so as to avoid the need for an external pumping system with its complexity, and     its associated risks and costs.      The use of a heating cable (prototype hereinafter called Thermowire, made by the company EFS,     which is in charge of its development) was patented and tested in pigs in two studies that     included 15 animals altogether (in 7 of which the heating cable was used). The aim of the     first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the     quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of     the chemotherapy were evaluated in a second study. The results obtained justify transfer to     use in humans in the context of a clinical trial so as to obtain CE certification.   "
32314|NCT02862886|"     CHRONOLOGICAL DESCRIPTION OF THE STUDY        1. Information provided to study participants        2. Collection of written informed consent        3. Harvesting of myometrial biopsies        4. Creation of tissue explants using myometrial biopsies        5. Stimulation of the explants with LPS        6. Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative          stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to          prevent the appearance of oxidative stress and its consequences on tissues, as a          complement to previous studies, is an additional argument for the clinical development          of this class of pharmaceuticals in the management of threatened premature delivery and          labour induction.   "
32315|NCT02862873|"     The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist)     before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic     arterial pressure (SAP).      The expected results are a decrease in the frequency and severity of hypotension, thus     leading to improved comfort for the mother and decreased maternal and foetal morbidity.     Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation,     with sometimes severe consequences for neonates.      It has been established that episodes of hypotension alter foetal pH. Investigators therefore     hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the     infant.      One of the objectives of this study is also to observe a decrease in the quantity of     vasopressors used and thus to avoid the adverse effects of their use in high doses.      The expected results are thus an improvement in haemodynamic stability during spinal     anaesthesia for caesarean section.      The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive     Arterial Pressure) as the collection of haemodynamic data will allow greater precision with     the continuous measurement of AP, as well as a study of maternal cardiac output.   "
32316|NCT02862860|"     As glycaemic variability on the one hand and hypoglycaemia on the other are associated with     oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect     the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic     properties.      The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will     wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of     hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated     with proatherogenic alterations in lipoproteins, in particular:        -  LDL oxidation        -  HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant          capacity)   "
32317|NCT02862847|"     Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute     diarrhoea. They have been identified in the pathological stools of infants and     immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8%     depending on the virus, the cohort and the country studied.      To date, no study on these two viruses has been conducted in France to evaluate the     circulation and the pathogenicity of these viruses in subjects with diarrhoea.      The aim of this study is thus to:        -  show that these viruses are in circulation in France in infants younger than 5 years old          and that the proportions are similar to those reported in the literature.        -  confirm the relationship between the diarrhoea and the infection with these viruses.   "
32318|NCT02862834|"     In the context of this study, the investigators wish to take advantage of high-throughput     genetic techniques (microarray and high-throughput exome sequencing) to identify new genes     implicated in syndromic poikiloderma so as to improve the diagnostic decision tree in these     syndromes, opportunities for genetic counselling for patients and their families and the     follow-up of patients, notably with regard to the risk of tumours.      This study will make it possible to identify new genes implicated in syndromic poikiloderma     and improve the diagnostic strategy proposed to patients with these syndromes, and to propose     to patients a confirmed diagnosis, appropriate follow-up, notably with regard to the risk of     tumours, genetic counselling to families and eventually an antenatal diagnosis to couples who     would like to have one for future pregnancies.      The identification of new genetic causes of syndromic poikiloderma will also make it possible     to complete the current classification of these syndromes   "
32319|NCT02862821|"     The purpose of this study is to identify alterations of motivational processes related to     decision making in uncertainty condition associated with gambling addiction: by studying the     dynamics between brain systems involved in decision making and motivation.   "
32320|NCT02862808|"     Evaluation of diagnostic whole exome sequencing in patients with syndromic or isolated severe     intellectual disability without a molecular diagnostic, with suspected autosomal recessive     inheritance, allowing accurate genetic counseling in this high risk of recurrence group of     diseases   "
32321|NCT02862795|"     Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions.     Little is known about HPV carriage in anal canal previous to cancer occurrence in the     population and pre-neoplastic lesions, and their risk factors. PAPILLAN is a prospective     study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence in     anal canal in a population non selected by its HIV status. In that purpose patients are     prospectively recruited in a french university hospital gastroenterology unit and anal smears     are collected during a colonoscopy with cytobrush.   "
32580|NCT02859311|"     One third of patients diagnosed with heart failure demonstrate left ventricular reverse     remodelling and recovery of cardiac function following a period of medical therapy. These     patients have an excellent long-term prognosis. Whether they need to remain on long-term     medical therapy is not clear. The investigators will investigate the safety of therapy     withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac     function, in a randomised controlled trial.   "
32322|NCT02862782|"     Background      The trigger for the final maturation of the ovum by providing integration of Human Chorionic     Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced     long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF     treatment.      In a recently published work which compared two types of ovulation induction (standard dose     of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a     statistically significant increase in the rates of implantation, clinical pregnancies and     live births rates by providing integration of hCG and GnRH agonist.      To conclude, providing GnRH agonist in combination of hCF in standard dose is today an     accepted treatment for final maturation of the ovums.      OBJECTIVE      The investigators objective is to investigate whether providing integrated treatment of     Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to     final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and     live births rates in women treated with GnRH Antagonist protocol.      The main objective is to compare between two existing treatments.   "
32323|NCT02862769|"     The aim of this study is to evaluate the impact of intravenous lidocaine on acute and chronic     post surgical pain on patients undergoing video assisted thoracoscopic surgery(VATS). The     investigators believe that systemic administration of lidocaine during the perioperative     period would be effective in preventing chronic pain post VATS. In addition to chronic pain     the investigators believe it will reduce acute postoperative pain as well as each patients     total opioid requirement.The investigators believe that this will have a significant impact     on the care of patients presenting for VATS.   "
32324|NCT02862756|"     Endovascular treatment of ruptured and unruptured intracranial aneurysms presents     complications, mainly the thrombo-embolic complication. No specific studies have been     conducted to study factors associated with the occurrence of thromboembolic complications     (symptomatic or not) post endovascular treatment of intracranial aneurysms.   "
32325|NCT02862743|"     Analysis of somatic mutations in tumors is currently indicated for daily practice in all     metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers     validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some     cases it requires invasive biopsies.      In this context, molecular characterization of a tumor material flowing (circulating tumor     DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions     of current targeted therapies and future.   "
32326|NCT02862730|"     Closed-loop systems are an emerging technology that automate hormone delivery. They are     quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories     have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems     with insulin only, one variety of which is the low glucose suspend safety feature now     available from Medtronic (MiniMed 530G with Enlite). The study described within this protocol     is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in     people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a     single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin     only mode with predictive low glucose suspend, all with an exercise detection algorithm. The     purpose of this study is to determine whether a dual hormone AP with an exercise detection     algorithm outperforms both single hormone AP and a low glucose suspend algorithm and current     care using the subject's own insulin pump.   "
32327|NCT02862717|"     End-stage renal disease represents a major problem for public health, and is a severe disease     affecting hundreds of millions of people in the world and increasing rapidly. It brings about     complex implications to social and economic structures of every nation. Providing renal     replacement therapy including , peritoneal dialysis and renal transplants for ESRD patients     are resource intensive. Possible options have been proposed to ease the burden include early     medical intervention to slow the progression of chronic kidney disease in high-risk patients,     promotion of renal transplantation, and use of the most cost-effective dialysis therapy     without compromising outcome. In Malaysia, despite growing financial pressure in health care     system, cost-effectiveness studies of RRT modalities are scarce.The prevalence of ESRD     patients on dialysis are approximately 34, 767 as of 2014 and expected to rise significantly     in the foreseeable future. Thus, the sustainability of dialysis therapy is uncertain. This     study aimed to assess the cost utility of hemodialysis and continuous ambulatory peritoneal     dialysis treatment from Malaysia Ministry of Health perspective. One hundred and eighty     patients will be recruited from five state hospitals via National Renal Registry. Patients'     resource utilization including overhead costs, medications, dialysis consumables and     hospitalizations will be recorded using specially designed case report form. Patients'     quality of life will be assessed using validated EQ-5D-3L questionnaire. Survival analysis     will be conducted based on NRR data. Next, a hypothetical cohort Markov model will be     constructed to assess the cost utility of HD and CAPD using varying levels of CAPD use versus     current practice. The data collection period is from 1st October 2016 to 30th September 2017.     Incremental cost effectiveness ratio is the primary outcome of this study.   "
32328|NCT02862704|"     The purpose of this study is to collect the data on the safety and potential effectiveness of     intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver     metastases expressing MG7 positively.   "
32329|NCT02862691|"     The goal of this study is to compare the speed and adequacy of pain relief in Emergency     Department patients with a toothache after an oral analgesic or a local anesthetic     administered as a nerve block or by local infiltration.   "
32330|NCT02862678|"     Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part     of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI)     is a non radiating imaging, not requiring injection of gadolinium, giving informations on     tumor activity, based on the brownian motion of water molecules. The differences in motion     are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes     in water molecules motion and redistribution between the intra- and extracellular     compartments. Several studies have shown that malignant lesions have an ADC coefficient     lowered as compared to benign lesions.   "
32343|NCT02862509|"     o Chronic rhinosinusitis is one of the most common health issue affected American population.     Surgery plays an important role in the patients who failed the medical treatment. The most     difficult location to be operated endoscopically is the frontal sinus. Frontal sinus is also     found to be one of the most common sinus for residual and recurrence after the operation.     Intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. The     topical therapy can be delivered by many approaches. According to the standard clinical     practice guideline and recommendations, intranasal corticosteroid spray is suggested. The     technique proved to have greater distribution than standard intranasal spray is instillation     of steroid nose drops. The head position for instillation of steroid nose drops proven to     have a greater access to olfactory cleft and frontal area is Vertex-to-floor position.   "
32331|NCT02862665|"     In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products     transfusions are often necessary to control intraoperative and postoperative bleeding.     Furthermore, approximately 50% of all patients undergoing cardiac surgery are anemic before     surgery, and patients with normal hemoglobin level may become anemic during and/or after     surgery. Perioperative transfusion carries risks far beyond transmission of infection and has     been demonstrated to be associated with adverse outcomes related to postoperative pulmonary     complications, decreased renal function and increased mortality. Thus, the important of blood     conservation stratigies to minimize transfusion is being increasingly emphasized. In recent     trial by Johansson and colleagues, they concluded that the perioperative administration of     intravenous iron isomaltoside 1000 increased the hemoglobin level and prevented anemia 4     weeks after cardiac surgery. Therefore, perioperative iron isomaltoside 1000 administration     among the patients undergoing complex valvular heart surgery could reduce not only the     perioperative allogeneic transfusion but also the incidence of postoperative adverse events.     The aim of this study is to examine the effect of perioperative iron isomaltoside 1000     administration on transfusion requirements in patients undergoing complex valvular heart     surgery.   "
32332|NCT02862652|"     Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic     strategies allow healing of over 80% of children. However these treatments are associated     with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during     treatment initiation, are the thromboembolic complications.      The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy     used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no     efficacy in the prevention of these thromboembolic complications. Therefore most authors     consider that a multifactorial mechanism is behind these events, involving both treatment and     malignant cells. The interaction of these two factors participate in the damage of the     vascular endothelium.      The microparticles are membrane fragments derived from budding from the membrane of activated     cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation     activators such as tissue factor. It is also associated with their role in the modulation of     signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.      In acute lymphoblastic leukemia, the presence and role of microparticles have not been     studied. Our hypothesis is that of production of microparticles upon lysis of blasts then     upon activation of endothelial cells induced by the induction therapy, participating in a     procoagulant phenotype.   "
32333|NCT02862639|"     The current management of osteoarthritis is based on non-pharmacological and pharmacological     means which include intra-articular injections.      The recommendations on the management of hip osteoarthritis stipulate that intra-articular     injections of corticosteroid may be considered in patients with an exacerbation not     responding to oral treatments. Several recent studies show the effectiveness of     intra-articular corticosteroids compared with anesthetics. The intra-articular injection of     viscosupplementation alone has never been validated in this indication since controlled     studies did not show efficacy over placebo. At present, viscosupplementation is considered an     anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in hip     osteoarthritis.   "
32334|NCT02862626|"     The incidence of type one diabetes is still rising, especially in children under 5 years old.     Mothers often are the primary caregivers of these children. To take care of a young child     with diabetes is a great responsibility and mothers must be constantly vigilant. This study     aims to assess the psychological state of these mothers (in term of depression, anxiety,     stress, coping, fear of hypoglycemia) and factors which influence this state.   "
32335|NCT02862613|"     Objectives:      To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With     TACE in Advanced Liver Cancer.      Eligibility:      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of     age who have been diagnosed with Advanced Liver Cancer.   "
32336|NCT02862600|"     The purpose of this study is to evaluate the effect of perhexiline on exercise performance     (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe     heart failure following dosing for 16 weeks.   "
32337|NCT02862587|"     Objectives:      To evaluate the safety and effectiveness of cell therapy using precision cells to treat     Advanced Lung Cancer.      Eligibility:      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of     age who have been diagnosed with Advanced Lung Cancer.   "
32338|NCT02862574|"     The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745)     versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and     methotrexate in adults with moderate to severe rheumatoid arthritis (RA).   "
32339|NCT02862561|"     Objectives:      To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy     to treat Advanced Gastric Cancer.      Eligibility:      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of     age who have been diagnosed with Advanced Gastric Cancer.   "
32340|NCT02862548|"     The primary objectives of this study are to evaluate the safety, tolerability, and efficacy     of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens     in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic     kidney disease who have received a liver transplant.   "
32342|NCT02862522|"     Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the     association with inflammation and coronary microvascular endothelial dysfunction is not     well-defined. The aim of this study was to determine the relationship of serum uric acid,     inflammatory markers and CED.   "
32344|NCT02862496|"     The purpose of the study is to determine whether maternal bone resorption would be seen in     Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels,     serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in     the patients with Hyperemesis Gravidarum.   "
32347|NCT02862457|"     This is an open-label, non-randomized, Phase I study of MK-3475 (pembrolizumab) and     INCB024360 (epacadostat) in participants with advanced solid tumors. The primary objective of     the trial is to evaluate the safety and tolerability of INCB024360 administered alone and in     combination with MK-3475.   "
32348|NCT02862444|"     Postpartum depression (PPD) is a highly prevalent and serious mental health problem and is     defined as the most recent episode of depression occurring between four weeks and twelve     months after childbirth. PPD has negative effects, which are usually strongest during the     first six months and may decrease the quality of mother-child interaction, adversely     affecting the child's behavior and emotional and cognitive development, as well as the spouse     marital relationship.PPD prevalence is estimated at 10 to 20%. A recent studies among     Arab-Bedouin women, reported 31% - 43 of PPD.      Aims: To develop and implement a culturally appropriate intervention program by using focus     group (FGs) methodology      Methods and Research program description: The study includes two phases. First, qualitative     study will be conducted by using focus groups (FGs) method and based on the results of this     phase we will develop a culturally based program. The second phase will include     implementation and evaluation of the effectiveness of a culturally appropriate intervention.   "
32349|NCT02862431|"     The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult     Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.   "
32350|NCT02862418|"     This research study has 2 purposes:        1. To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures          of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as          traditional MRI.        2. To collect images and health information about lungs that have different kinds of lung          diseases to compare to healthy lungs. This collection will help researchers and          clinicians to better understand lung variations in health and disease.      This study will involve one MRI session that will take about 10 to 30 minutes and for some     participants a breathing test that measures how well the lungs are working. This test is     called spirometry.   "
32351|NCT02862405|"     The loss of central vision causes difficulty not only in reading but also in faces     recognition, and in particular in the identification of facial expression, objects or spaces.     These visual deficits have been mainly studied in relation with reading, which is the main     complaint of these kind of patients. However, there are not enough data regarding perception     of objects and spaces in this population. Then, the objectives are to study the     visual-spatial abilities in individuals with vision loss, and altered cognitive processes,     (2) to develop clinics tools for early detection and quantification of visual-spatial     deficits and (3)to understand the capacities of normal peripheral vision in order to test the     possibility of potential training for use of peripheral vision when central vision is     impaired by an ophthalmic pathology.   "
32352|NCT02862288|"     The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety     of microwave ablation in the treatment of malignant bone, lung and renal tumors.   "
32353|NCT02862275|"     This phase I trial studies the side effects of atezolizumab in treating patients with cancer     following adoptive cell transfer. Monoclonal antibodies, such as atezolizumab, may interfere     with the ability of tumor cells to grow and spread.   "
32354|NCT02862262|"     A three-arm, multi-site clinical evaluation of the ARIES Bordetella Assay for the detection     and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B.     parapertussis) nucleic acids in prospectively collected, de-identified, left-over clinical     specimens; banked, pre-selected clinical specimens; and contrived specimens.   "
32355|NCT02862249|"     Patients with advanced cirrhosis have enteric dysbiosis with small bowel bacterial overgrowth     and translocation of bacteria and their products across the gut epithelial barrier. This     culminates in systemic inflammation and endotoxemia which induces innate immune dysfunction     predisposing to infection and development of complications such as bleeding, sepsis and     hepatic encephalopathy. It also plays a key role in the natural history of cirrhosis by     influencing the rate of progression to advanced liver disease and terminal liver failure.      The investigators propose an intervention utilising Faecal Microbiota Transplantation (FMT)     from a healthy donor to modify the gut microbiome alleviating gut dysbiosis and immune     dysfunction. This may ultimately reduce the progression to chronic liver failure and the     development of infection and organ dysfunction.      The primary objective of this study will be to assess whether stabilising gut dysbiosis with     FMT in patients with advanced cirrhosis is both feasible and safe.   "
32356|NCT02862236|"     The experiment is aimed to examine the effect of common psychiatric drugs on several     cognitive functions, in a healthy and subclinical adult population. The investigators     hypothesize that baseline stress level regulates drugs effects on cognitive performance.     Additionally, different levels of stress may moderate the drugs-cognition relations. In order     to examine our hypotheses, the investigators focus on two anxiolytic drugs: herbal based     (Hypericum) and benzodiazepine (Alprazolam). about 160 healthy (and/or subclinically anxious)     subjects (aged 18-40) will be administered with single dose of the drugs (between subjects)     on two different experiment dates - so subject that will be administered with a drug will     receive placebo on the second date, or vice versa. The design will be double blind and second     experiment day will occur at least 14 days after the first. Prior to administration, the     investigators will measure depression and trait anxiety and state stress and anxiety, using     inventories and cortisol in saliva test. Subjects will undergo a battery of computerized     cognitive tests measuring working memory, attention, executive control, and visual     perception. State anxiety and stress will be also measured before and after the battery. A     gentle stress manipulation will be conducted during some of the tests.      currently, the research is focusing on a Hypericum and placebo only, regarding 60     participants.   "
32358|NCT02862210|"     Frontotemporal dementia (FTD) is a progressive neurodegenerative illness that affects the     frontal and anterior temporal lobes of the brain. Changes in behavior, including agitation,     aggression, and repetitive behaviors, are common symptoms in FTD. The investigators currently     do not have good medications to treat these symptoms in FTD, and the medications the     investigators use often have side effects. In this project, the investigators will test the     use of low-dose lithium, compared to a placebo pill, for the treatment of behavioral symptoms     in FTD. Lithium greatly reduces the behavioral symptoms of bipolar disorder, and many have     found low-dose lithium to be well-tolerated in patients with dementia. Lithium appears to     inhibit the creation of a protein involved in many cases of FTD called tau.   "
32525|NCT02860026|"     This clinical trial will compare the growth and tolerance of infants who consume an     investigational cow's milk-based infant formula to those who consume a marketed cow's     milk-based infant formula through approximately 4 months of age.   "
32359|NCT02862197|"     The purpose of this study is examine whether invasive pulmonary artery pressure (PAP)     monitoring could be beneficial for the patients in dialysis treatment. Ten implantable     pressure sensors (CardioMEMS ®) will be implanted and the PAPs of the individual participants     are recorded during and in between the routine dialysis treatment sessions. This is an     exploratory pilot study, where major interest lies in the values and changes in PAP in     relation to other hemodynamic parameters among patients in dialysis treatment. Implanted     device is only monitoring the patient without any effect on the actual treatment.   "
32360|NCT02862184|"     Many women will likely experience a sexual problem in their lifetimes. The Prevalence of     Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking     (PRESIDE) study surveyed more than 30,000 U.S. women aged >18 years regarding sexual     function. Results from this study estimated that 12% of women experience a diagnosable sexual     disorder that causes personal distress, with lack of sexual desire being the most prevalent.     - See more at:     http://www.uspharmacist.com/content/d/featured_articles/c/56908/#sthash.LTDkyRlR.dpuf   "
32362|NCT02862158|"     This is a single center, prospective study to evaluate the efficacy and reproducibility of     frequency doubling technology (FDT)-based visual field devices compared to conventional     Humphrey Visual Field (HVF) perimetry. The investigators plan to enroll 500 patients in this     study.   "
32363|NCT02862145|"     This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics     of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with     easily accessible lesions will undergo serial biopsies and serial blood samples will be     collected.   "
32364|NCT02862132|"     Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7     integrin which modulates lymphocyte trafficking in the gut.      Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in     induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease     (CD), respectively.      Recent real life cohorts in adults support the effectiveness of VDZ in inducing and     maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the     use of VDZ besides two retrospective case series.      Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults     and practically non-existent in children.      The investigators aim to prospectively explore the real life short and longer term outcomes     of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment     success based on VDZ trough levels and other clinical and laboratory variables.   "
32365|NCT02862119|"     Background: The best strategy for ST-elevation myocardial infarction (STEMI) patients with     multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the     infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still     not well established. Current guidelines recommend PCI of only the infarct related artery     (IRA). However, recent small scale randomised controlled trials indicate that full     revascularization of these non-infarct related arteries during the index procedure is     superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to     determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI     in stable angina.      Objective and methods: To test the hypothesis that a strategy of systematic complete     revascularization with FFR-guided PCI following STEMI/very high risk NSTEMI leads to improved     clinical outcomes at one year compared to initial conservative management of non-culprit     lesions. The trial is a prospective international multicentre registry-based randomized     controlled trial with combined primary endpoint of all-cause mortality and non-fatal MI at     one year. Key secondary endpoint is unplanned revascularization. 4052 patients with acute     STEMI/very high risk NSTEMI with multi-vessel disease in Sweden, Denmark, Norway, Finland,     Iceland, Latvia and Poland will be randomized into 2 arms:        1. FFR-guided PCI of non-culprit lesions during index hospital admission or        2. Initial conservative management following acute PCI of the culprit lesion(s) or      Randomization and data collection in the registries - the Swedish Coronary Angiography and     Angioplasty Registry (SCAAR) and corresponding registries in other countries (or electronic     data capture) - will ensure low bias, high inclusion rate and excellent follow-up of events     at a low cost. Adjudication of clinical events and collection of data from other registries     including death cause registries is also planned.      Significance: If this study shows that FFR-guided PCI of non-culprit lesions in STEMI/very     high risk NSTEMI improves clinical outcome compared to conventional management this will     change practise in how we should best manage these patients. Therefore a study of this size     will definitely be of great importance in determining future guidelines for this large     patient group to reduce both morbidity and mortality.   "
32366|NCT02862106|"     The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based)     treatment in chronic hepatitis B patients and to explore the most effective dosage and     provide the rational for optimal dosing schedule.   "
32367|NCT02862093|"     Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex may     affect neuro-adaptations associated with alcohol use disorder (AUD), potentially influencing     craving and alcohol intake.      Investigators investigated alcohol intake and dopamine transporter (DAT) availability by     Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and     after deep rTMS.   "
32368|NCT02862067|"     To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness     in patients with systolic heart failure.   "
32369|NCT02862054|"     To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic     lymphohistiocytosis (HLH) in patient with unknown etiology.   "
32370|NCT02862041|"     In this prospective, randomized, double blinded study, the needle tip and needle shaft     visibility of echogenic and nonechogenic needle were compared in ultrasound guided     infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery     were included in the study. Patients were randomised into two groups, group E (Echogenic) and     group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance     infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic     needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective     assessment for needle tip/shaft visibility as scored by the performer and the objective     assessment from the recorded block procedure video were noted.   "
32372|NCT02862015|"     Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality     of life have seriously deteriorated. There have been a few studies that showed an effect for     pain control by hyperthermia (heating the patient's body). However, there are several     limitations in conventional hyperthermia.      In a previous pilot study (NCT02150135), we found the improvement of quality of life,     function, and symptom.      From this background, the investigators tried to show the effect of Oncothermia with     conventional chemotherapy for pain control, increasing quality of life, and anti-tumor     treatment.   "
32829|NCT02856113|"     This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD) compared     to placebo when administered as monotherapy, or when added onto a background of metformin     alone, insulin alone, or a combination of metformin and insulin in pediatric participants 10     to 17 years of age with type 2 diabetes mellitus (T2DM).   "
32373|NCT02862002|"     A first empirical evidence on the difficulties of observance of morphine in cancer patients     invited a multidisciplinary team to initiate an innovative quality approach. It shows the     lack of transcript of a comprehensive care causing a problem for monitoring actions     undertaken for the relief of pain. In addition, two exploratory studies targeting the     expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids.      The E.T.P, public health priority, provides a framework for action and improving care. In     oncology, the involvement of the patient in pain relief and management of opioids represents     an axis of intervention more appropriate. Yet, it is not found in literature. In our     department, we conduct an experimental therapeutic education program type caratif and a     nurse consultation FTE receiving opioids on the model of nursing care of J. Watson     (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient     experience). The ETP folder and its tools have been continuously validated with patients. The     heart of the educational process is in the patient's complex path neat oncology and relies on     interaction and creativity between patient and caregivers.   "
32374|NCT02861989|"     Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high     mortality in the elderly. Despite numerous programs aiming at improving OP care, the     prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are     multiple, both in the general and at-risk population, and in medical practitioners. Since     they do not perceive their susceptibility to OP, people do not see the benefit of prevention.     In addition, physicians do not give sufficient importance to OP prevention and care, despite     the existence of guidelines.      The investigators implemented a qualitative study to explore the knowledge and     representations regarding osteoporosis in the general and at-risk population and in doctors     in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured     face-to-face interviews with general practitioners. Understanding barriers to osteoporosis     care in patients and general practitioners will help to set up effective strategies to     improve prevention and treatment.   "
32375|NCT02861976|"     The current study seeks to begin the crucial work of creating effective protocols to prevent     opioid misuse, addiction, and related complications by developing and pilot testing an opioid     risk screening protocol at Wisconsin trauma centers.   "
32376|NCT02861963|"     The aim is to compare effective growth true hypoplastic pulmonary arteries using Right     Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and modified     Blalock-Taussig shunt   "
32377|NCT02861950|"     This is a prospective randomized multi-center non-inferiority trial conducted through the     Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the     incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair     compared with penile nerve block.   "
32378|NCT02861937|"     Human IL-21 is present in gingival crevicular fluid in periodontal health, gingivitis and     chronic periodontitis. A significant increase in the concentration of IL-21 in gingival     crevicular fluid is observed with an increase in the amount of periodontal destruction. Non-     surgical periodontal therapy aided in decrease of GCF IL-21 levels in clinical gingivitis and     chronic periodontitis   "
32379|NCT02861924|"     Measure microcirculatory responses after localized ischemia obtained by local application of     pressure (laser speckle).   "
32380|NCT02861911|"     Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal dominant disease characterized     by progressive weakness and atrophy of specific skeletal muscles. One of the major problems     of patients affected by FSHD is the limitation in performing daily activities induced by the     progressive muscle weakness. This sedentary lifestyle can cause a debilitative cycle, and     neuromuscular deconditioning can even aggravate the muscular deficiencies. Recent studies     have indicated the safety and the effectiveness of moderate aerobic training programs in     patients with FSHD. However, these training programs have limited applicability in patients     with more severe muscular weakness. Artificial strength training by means of neuromuscular     electrical stimulation (NMES) appears to be a promising rehabilitation strategy for FSHD     patients suffering from neuromuscular disorders. Therefore we propose to investigate the     feasibility, safety, and effectiveness of NMES strength training to counteract quadriceps     muscle weakness in patients affected by FSHD.   "
32381|NCT02861898|"     Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically     treated by surgery, radiation therapy and chemotherapy, either individually or in     combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate     for brain cancer patients, with median survival at approximately 12 months. Glioma is the     most common form of primary brain cancer, afflicting approximately 7,000 patients in the     United States each year. These highly malignant cancers remain a significant unmet clinical     need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor)     which is blocked by Cetuximab (CTX). The investigators have recently completed a separate     Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX     after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in     revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of     CTX is well tolerated with few adverse effects. The investigators hypothesize that in     patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and     efficacious for our patients when combined with standard chemoradiation (STUPP protocol).      This trial will be a non-randomized open label Phase I/II clinical trial. In addition to     standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX     intra-arterially after BBBD for a total of three doses at approximately post surgery days 30,     120 and 210.   "
35484|NCT02821338|"     The objective of this study is to determine bioequivalence between two different formulations     of lamotrigine extended release tablets (one reference product and one generic product) in a     healthy adult population, following a single oral dose under fed conditions.   "
32418|NCT02861417|"     The goal of this clinical research study is to learn if busulfan with cyclophosphamide (when     given with other helper drugs listed below) can help control acute myeloid leukemia (AML),     acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic     leukemia (CLL), myelodysplastic syndrome (MDS), myeloproliferative syndrome, Non-Hodgkins     lymphoma (NHL), Hodgkins lymphoma (HL), or multiple myeloma (MM) when given before a stem     cell transplant. The safety of these study drug combinations will also be studied.   "
32382|NCT02861885|"     There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently     identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a     new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would     be faster than through the usual adenoma to cancer way. It would be then responsible of a lot     of missed lesions or interval cancer. The missed SSL rate is estimated at between 27% and     59%.      Current diagnosis methods show weakness to identify those SSL. In order to improve their     detection, the investigators dispose of several coloration techniques. Indigo carmine     chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal     carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any     efficacy on the adenoma detection rate, except for patients with Lynch syndrome.      The objective is to better describe the SSL endoscopic semiology (detection and     characterization) and to establish standards for the endoscopic techniques in order to     improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2     fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used     for other indications, in comparison with the White Light technique (WLI).      Therefore, the investigators propose a prospective, observational, multicentric cohort study     in order to 1) define SSL endoscopic various aspects 2) establish which technique (white     light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL,     namely detection and characterization 3) evaluate the multifocal dimension rate for those     lesions at ascending colon level.      The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic     NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic     diagnosis. Better SSL detectability thus their systematic resection could have a long term     effect in reducing both colon cancer rate and interval cancer   "
32383|NCT02861872|"     Ovarian cancer is the third most common gynecological malignancy worldwide. Because of late,     aspecific symptoms, the disease is usually diagnosed at an advanced stage. Most patients     experience recurrence and die as a result of the disease within 5 years. Treatment is a     combination of surgical debulking and systemic administered chemotherapy. Intra-peritoneal     (IP) chemotherapy with is currently considered the most effective treatment. In patients with     at least an optimal surgical debulking, this leads to an improvement in life expectancy from     50 to 66 months. IP administration of chemotherapeutic agents is still not common practice.     Furthermore recent studies revealed that cancer cells express a variety of tumor antigens,     which can be targeted by the immune system. Also ovarian cancer shows evidence of a role for     the immune system in clinical outcome. Novel insights into the mechanism of action of     chemotherapy indicate that the efficacy of chemotherapeutic interventions are dependent on     the modulation of the immune system. The impression exists that since IP chemotherapy is     used, relatively more recurrences outside the abdominal cavity are observed. As of yet, no     studies have described pharmacokinetics and pharmacodynamics of IP administered cisplatin and     paclitaxel in the blood circulation. The investigators propose to study the use of this     aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy     intervention, monitor the effect of chemotherapy on IP tumor cells in the peritoneal cavity     and monitor the effect of chemotherapy on immune cells present in the IP cavity. As well the     investigators propose to correlate the presence and amount of tumor cells in peritoneal fluid     with the debulking efficacy and CA 125 levels. Secondary to this the investigators intend to     determine the pharmacokinetics of cisplatin and paclitaxel when administered in the IP cavity     in the central circulation (plasma) as well as in the peritoneal fluid. In this observational     explorative study women, aged younger than 70 years, who will receive standard IP     chemotherapy for advanced epithelial ovarian cancer, who are in an adequate physical and     biochemical state to receive chemotherapy are included. Immunological cell counts, tumor     marker, immunological cell pathway activation and plasma concentrations of cisplatinum and     paclitaxel in venous blood and in fluid aspirated from the abdominal cavity will be measured.   "
32384|NCT02861859|"     The purpose of this study is to evaluate whether adding olanzapine 5mg to standard antiemetic     medication can significantly reduce chemotherapy-induced nausea and vomiting in breast cancer     patients receiving emetogenic chemotherapy regimens such as anthracycline with     cyclophosphamide-based chemotherapy and platinum-based chemotherapy.      To help clinicians prescribe antiemetic medications in a more patient-centered,     evidence-based and cost-effective manner, we've developed the world's first validated     risk-stratification tool for chemotherapy-induced nausea and vomiting (CINV) and because of     this, it is now possible to perform a trial of personalized precision antiemetic therapy for     breast cancer patients.      Despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (CINV) remains     among the most feared and expected side effects of chemotherapy for breast cancer.     Inadequately controlled CINV can significantly reduce a patient's quality of life, impair     functional activity, lead to chemotherapy dose delays and reductions, and even     discontinuation of treatment. The merit of current antiemetic medications is based on their     ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is     the major issue for breast cancer patients.      With olanzapine demonstrating significant promise in preventing acute and delayed nausea, the     investigators are proposing to evaluate guideline-recommended aprepitant-based triple regimen     compared to the same regimen plus olanzapine (5 mg) for patients at high personal risk for     CINV. For patients at low personal risk for CINV the investigators will also evaluate     guideline-recommended double antiemetic regimen compared to the same regimen plus olanzapine     (5 mg).   "
32385|NCT02861846|"     Beyond 60 years, the prevalence of epilepsy is estimated at approximately 1% and increases     with age. In these patients, the etiology of epilepsy is unknown in 25% of cases, even up to     55% after 65 years. Although new-onset epilepsy in the elderly is associated with a vascular     disease in 50% of cases, the hypothesis of an ongoing neurodegenerative process, including an     Alzheimer's disease (AD), is also common. However, investigators do not have any marker that     might help to identify the patients who develop epilepsy after 60 years and who might be,     despite a normal cognitive functioning, already engaged in the pathophysiological process of     AD.      A number of data suggest a link between the pathophysiological process of AD and     epileptogenesis:      (i) a third of patients with epilepsy develops MA, (ii) the occurrence of epilepsy in AD is     an aggravating factor for cognition, (iii) in animal models of AD, the relationship between     neuronal hyperexcitability and amyloid deposits is bidirectional, the amyloid protein has a     pro-seizure effect and the presence of epilepsy increases the amyloid deposits, (iv) in these     models, the administration of an antiepileptic drug protects from deterioration of cognition,     (v) the close relationship between amyloid and neuronal hyperexcitability might be mediated     by the inflammatory processes associated with AD, and particularly the microglial activation     which role in epileptogenesis has been shown elsewhere.      Investigators hypothesize that in a subgroup of patients who develop epilepsy after 60 years,     the occurrence of epilepsy might reflect the presence of an ongoing amyloid pathology. Our     goal is to identify through biomarkers of AD in the cerebrospinal fluid of patients who     develop an epilepsy after 60 years with normal MRI and normal cognition those at high risk of     later developing clinically defined AD.      Identifying patients with amyloid pathology which would be expressed through epilepsy before     the onset of cognitive dysfunction might help to adapt both the management of seizures and of     the cognitive dysfunction.   "
32386|NCT02861833|"     This is a first care research focuses on the study of adaptation strategies implemented by     cancerous wound patients. Today, advances in treatment generally increases the life     expectancy of a patient with cancer. the patients thus live longer with their wound. How to     live then? The literature review shows that there is research on adaptation strategies in     cancer pathology and that different factors seem to interact with these strategies. However     the investigators have not found written on the theme cancerous wound and adaptation     strategies.      the investigators conducted a pilot study of this research in medical oncology, Prof. service     Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation centers     contacted but also areas for improvement. Indeed, the investigators now were doing a study of     adaptation strategies implemented by the patient time T of his life. However, adaptation is a     process in constant motion, the investigators want to identify two different time patients     coping strategies following a specific charge nurse taking.   "
32781|NCT02856672|"     The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme     Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate     oropharyngeal seal pressure in different head and neck positions and perform similarly during     pressure controlled ventilation in neutral position, despite differences in their structural     design.   "
32387|NCT02861820|"     The study purpose is to examine whether there are structural or functional differences in the     brains of individuals who use cocaine or amphetamines as opposed to control participants who     have never used cocaine or amphetamines. More specifically, it will allow the investigator to     see how the brain changes once people get sober and how those changes relate to successful     recovery. This study will allow the investigator to examine the interaction between     cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). Results     from this study will inform new biologically-based interventions to compliment existing     treatment programs, in the hope of leading the field in a new direction.   "
32388|NCT02861807|"     Alcohol use disorder (AUD) impacts millions of Americans and is associated with significant     behavioral, social, economic, medical, and neurobiological dysfunction, yet current     behavioral treatments for AUD are only modestly effective. The proposed research will test     the efficacy of a novel behavioral intervention, which combines brain stimulation with     mindfulness-based relapse prevention, and is hypothesized to improve neural dysfunction and     ultimately lead to large effect size reductions in heavy drinking among individuals with AUD.     Given that mindfulness and brain stimulation are already available for home use there is     great potential for the ultimate dissemination of the intervention on a large scale, which     could have a significant impact on public health.   "
32389|NCT02861794|"     Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees.     Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant     survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of     the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have     been developed to solve the problem. However, most of their designs are based on experimental     data and little has been studied about their actual performance in vivo. In this study, the     investigators will analyze the in vivo stability of the Global Medacta Knee Sphere (GMK     Sphere) implant. Migration of the implants will be monitored with a high precision measuring     method called Radiostereometric Analysis (RSA). The investigators assume the investigators     study will contribute the development of more satisfying knee implants.   "
32390|NCT02861781|"     This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do     so, a biological collection, including tissues of interest in the field of metabolism, will     be collected during bariatric surgery in obese patients. Three different groups of metabolic     status of patients, corresponding to different stages of evolution of the disease, will be     constituted: type 2 diabetes, insulin resistance, insulin sensitivity.      The main objective is to compare, between these 3 groups of patients, several biological     processes that may be involved in the pathophysiology of type 2 diabetes and disorders     associated with obesity, including:        -  Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma,          serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver)        -  Identification of metabolic signatures, protein and miRNA in plasma        -  Immunoinflammatory response in adipose tissue        -  Polymorphisms SNP from whole blood        -  Histological analysis of tissue sections This main objective will be studied on samples          taken at the time of surgery Secondary objectives will be to study the changes in          metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of          surgery, according to the initial metabolic state.   "
32391|NCT02861768|"     The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for     suspected tuberculosis.      Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis     pharyngeal.      Secondary        1. Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive          pharyngeal samples taken routinely.        2. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the          sample versus noninvasive pharyngeal samples taken routinely.        3. Beijing genotype prevalence among patients with pulmonary tuberculosis.   "
32392|NCT02861755|"     Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans     with depression receive adequate treatment, and one-third of those receiving treatment do not     benefit. In this pilot project investigators will bring together two approaches that have the     promise to reach large numbers of depression sufferers: a skills-based intervention for     increasing positive affect and experiences in depressed individuals, delivered in an     inexpensive self-paced mobile format. The study will make use of smartphone technology to     improve conventional outcome measurement via in-the-moment emotion sampling and mobile     assessment of heart rate variability, a predictor of cardiac health that may mediate some of     the health effects of depression. The aims are: 1) Retool the existing web-based positive     emotion intervention for use on smartphones, with innovative exercises that help participants     bring the skills they are learning into real-life situations; 2) Perform a small feasibility     trial of the mobile intervention on individuals with clinical depression recruited online 3)     Eventually incorporate feedback from the small feasibility trial to improve the online     intervention and conduct a full randomized trial on a larger scale   "
32393|NCT02861742|"     The KALICOU 3 study will evaluate the effect of emotional skills of patients and their     partners on their individual disease subjective experience during care pathways, from     chemotherapy to surveillance.   "
32394|NCT02861729|"     The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes     of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic     system compared to partial coverage restorations fabricated with lithium disilicate ceramic     system.   "
32395|NCT02861716|"     In this study the investigators aim to determine the analgesic effect and side effects of     intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric     patients undergoing major abdominal cancer surgeries.   "
32416|NCT02861443|"     The main objective of this study was to determine the frequency of the practice of colonic     irrigation (CI) among patients with a colostomy,.      Other objectives are:        -  To compare the quality of life between a group of patients with a colostomy and          practicing CI versus a group of patients with a colostomy without CI.        -  To determine the causes of non-realization of the CI or failure.        -  To determine the conditions of realization of colonic irrigation by the return of user          experience (time of day when the CI is practiced, amount and type of fluid used, time          spent in the bathroom, time to recurrence of stool, media used between two irrigations).   "
32396|NCT02861703|"     Obesity presents serious psychological and physical consequences for breast cancer survivors,     including diminished quality of life, poorer prognosis and increased mortality. As such,     there is a great need to develop strategies for these women to maintain optimal body weight.     Diet and exercise have been shown to lead to successful weight loss among this population but     these effects are seldom sustained, plausibly because these efforts alone overlook less     obvious, but equally important, psychosocial factors that can interfere with prolonged     progress. This study will implement a group-based intervention addressing diet and exercise     along with other psychosocial issues related to survivorship such as depression, fatigue,     body image and social support. Based on the growing popularity and benefits of computer-based     health care, including convenience and anonymity, this intervention will also be offered     online, representing the first of its kind. It is hypothesized that 1) women in both     intervention groups will achieve significantly greater loss in weight and improvement in     psychosocial well-being than those in a control group and 2) women in the online group will     achieve outcomes comparable to those in the face-to-face group. This research has the ability     to improve the long-term health of breast cancer survivors by incorporating psychosocial     interventions into standard medical care practices and has the potential to increase     accessibility of these services using online technology.   "
32397|NCT02861690|"     The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal     Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal     Carcinoma   "
32398|NCT02861677|"     Background: Pharmacists have been proven to improve patient outcomes, medication adherence,     glycemic control, reduce blood pressure, low-density lipoprotein, health care costs and     length of hospital stay, and enhance quality of life.      Objective: to measure the impact of clinical pharmacy service on patient care and cost saving     of patients at inpatient wards and ambulatory care clinics of Jimma University Specialized     Hospital.      Methods: single center Randomized Controlled Trial will be conducted. Participants will be     assigned to either pharmacy professionals' intervention group or non-intervention (control)     group based on computer generated random number. The study will be done from July 26 to     September 15, 2016. The total sample size is calculated with Open Epi online sample size     calculator with 95% CI and 80% power. The total sample size is found to be 146 for inpatients     and 473 for outpatients. Linear regression, student's t-test, logistic regression and     chi-square test will be used for statistical analysis. Variables with p<0.05 will be     considered statistically significant.   "
32399|NCT02861664|"     This study will evaluate the effectiveness of an experimental dentifrice containing stannous     fluoride, an established dentine tubule occlusion technology, at reducing dentine     hypersensitivity (DH) compared to a negative control dentifrice. The test and control     dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative     air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.   "
32400|NCT02861651|"     Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid     leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World     Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid     blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish     between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which     is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of     AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a     series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the     other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively.     Only three cases of AEL are reported in the TCGA database. To further characterize AEL,     determine whether it constitutes a distinct class of AML and document the reasons for its     poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using     array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106     genes known or suspected to have a role in myeloid malignancies or in erythrocyte     differentiation.   "
32401|NCT02861638|"     Postoperative rehabilitation is required for a successful outcome following total hip     arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to     strengthen quadriceps, to restore normal gait, and to recover independence in activities of     daily living. In the last decade action observation treatment, in addition to conventional     physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is     growing evidence of the applicability of action observation training in rehabilitative     medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of     cerebral palsy and of aphasia.      Nevertheless those are small studies and one of them included a mixed population of hip and     knee arthroplasty.   "
32402|NCT02861625|"     The aim of this randomized multicenter study is to evaluate the impact in offering the     condolence letter to the family caregivers (indicated as the reliable person by the patient     himself at each hospitalization) and a bereavement consultation with the reference physician.   "
32403|NCT02861612|"     This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in     patients with cervical spinal injuries.   "
32415|NCT02861456|"     The goal of the proposed research is to test the feasibility of a functional progression     program to reduce cost and possible radiation exposure for adolescent athletes with low back     pain. Specifically the investigators plan to test the feasibility of using progression in     rehabilitation to pragmatically differentially diagnose and treat adolescent athletes with     low back pain, instead of using advanced imaging which is the current practice. The     investigators propose to recruit 20 participants, with 10 of usual care (advanced imaging)     and 10 of proposed intervention (functional progression) to assess the feasibility of using     functional progress to guide treatment. The outcomes measured will be number of days for     rest, time to start regular rehabilitation, pain experienced, functional outcomes, ability to     return to sport, time needed to return to sport. If this pilot demonstrates the feasibility     and a decreased rate of advanced imaging and similar clinical outcomes the investigators plan     to progress this work into larger trials.   "
32417|NCT02861430|"     Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular     biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for     non metastatic colon cancer.   "
32404|NCT02861599|"     Before proposing this observational study protocol, a randomized study was attempted. This     consisted in proposing to families of children with difficulties in learning to read, via the     speech therapists who were treating them, to take part in a randomized trial that compared     speech therapy alone with a combination of speech therapy and proprioceptive therapy. If     parents agreed in principle with the study, the child underwent a complementary speech     therapy examination and was referred to the nearest investigating doctor for inclusion.     However, this study had to be abandoned because of insufficient recruitment (2 patients     included in 1 year). Despite the motivation and training of participating speech therapists,     proposing a study based on randomization to families often in distress proved to be extremely     difficult, as their conviction of the interest of proprioceptive therapy was greater than the     available scientific evidence suggested. Direct recruitment by investigating ophthalmologists     was not possible because they were consulted directly by the families so as to obtain     proprioceptive therapy. The principle of randomization would thus not have been accepted.      In light of the above, we decided to turn towards a non-randomized study comparing outcomes     in two groups of children:        -  children who consulted an ophthalmologist who proposed proprioceptive therapy in Côte          d'Or        -  children managed by one of the four speech therapists who do not propose proprioceptive          therapy and who accepted the principle of the study.   "
32405|NCT02861586|"     The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine     against Chikungunya virus after one or two vaccinations by comparison of two different dose     levels.   "
32406|NCT02861573|"     The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475)     combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC).     There will be three cohorts in this study with 70 participants enrolled in each cohort:     Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab +     docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome     measures will be assessed individually for each cohort.   "
32407|NCT02861560|"     A prospective case series investigating the efficacy and safety of dehydrated human     amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure     ulcers   "
32408|NCT02861547|"     Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The     Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis.      The aim of this study is to define and to evaluate a prognostic score for early death based     on clinical and CT-scan findings in an observational retrospective derivation cohort of     patients hospitalized for traumatic brain injury.      This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create     a prognostic score for early death.      We will subsequently test this score in a prospective validation cohort.   "
32410|NCT02861521|"     Moving one's joints through their full range of motion (ROM) is crucial for health and     wellbeing. Those who are unable to do so have difficulty carrying out simple activities like     walking or feeding themselves. Lost joint ROM is called a contracture. Osteoarthritis (OA) is     the most common form of arthritis. About a third of people with knee OA develop knee flexion     contractures (KFlCs), the inability to fully straighten the knee. Having a KFlC before a knee     replacement is a big risk factor for redeveloping one after the operation. Many people with a     KFlC in the knee for surgery also have a KFlC in the other knee. The investigators believe     that this non-surgical KFlC increases the risk of re-developing a KFlC in the surgical knee     after surgery by encouraging bending of the surgical knee to avoid one leg being shorter than     the other. No one has ever looked at whether fixing this leg length difference using a shoe     lift would prevent this problem and there is little information to help design such a study.     Here the investigators will see if testing shoe lift use for preventing KFlC is feasible. The     investigators hypothesis is that a study evaluating the benefit of using a shoe lift to     correct leg length difference in the non-surgical knee is feasible.   "
32411|NCT02861508|"     The purpose of the proposed research is to examine whether incorporating point-of-care     ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect     diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared     to usual care.   "
32412|NCT02861495|"     The proposed study of humeral shaft fractures in adults will examine outcomes in patients     treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures     (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an     internal gear system controlled wirelessly by rare earth magnets, which typically offers     distraction for lengthening. In the humerus however, during the treatment of acute fractures,     this percutaneously inserted nail can also offer compression during the healing process,     thereby negating the effect of gravity, which may in turn lead to a faster and more     consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of     the nail may employ an accordion technique (alternating compression-distraction, a feature     unique to this implant.   "
32413|NCT02861482|"     Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major     causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic     medical disorders (including inherited and acquired coagulopathy). Management of PPH contains     the application of uterotonic agents, using hemostasis agents, transfusion of blood component     products, conservative procedures (intrauterine packing or balloon tamponade, compression     sutures, vascular ligation and uterine artery embolization using sponges), and even     hysterectomy.      The Bakri Balloon has attained its efficacy and popularity ever since it was invented by     Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH     management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data     of preventive usage.      The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early     management of PPH.   "
32782|NCT02856659|"     Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To     test speech understanding in each device and usability of upgrade.   "
32419|NCT02861404|"     The principal objective of the study is the evaluation of the role of Human Papilloma Virus     (HPV) in plantar warts (prevalence, genotype), resistant or not, treated or not, cured or     not. This epidemiological study is an ancillary study of the prospective, randomized     controlled, clinical study VRAIE (sponsor: APHP) comparing 5 usual strategies in the     management of plantar warts.   "
32421|NCT02861378|"     Dental procedures often require the use of local anesthesia. The effects of the anesthesia     usually linger for some time after the dental procedure is completed which can lead to     discomfort and occasionally injury from lip/tongue biting. Clinical trials have shown     phentolamine mesylate (OraVerse) to be effective at reducing the amount of time to reversal     of local anesthesia compared to sham injections. However, no trials have been conducted     comparing phentolamine mesylate to a true control injection. Such trials are needed in order     to definitively show that it is the phentolamine mesylate itself that is causing the     reduction in anesthesia rather than a dilution effect.      The objective of the proposed research is to conduct a pilot-scale randomized clinical trial     evaluating the difference in time required to the return of normal soft-tissue sensation and     function in participants who had received an inferior alveolar nerve block (using 2%     Lidocaine 1:100,000 epinephrine), followed by an injection with either 1) OraVerse     (phentolamine mesylate) or 2) sterile physiological water (control).      The study population will comprise dentistry and dental hygiene students of the second year     classes at Dalhousie University, Halifax, NS, Canada. This study population has been chosen     because these students usually practice dental anesthesia on each other as a part of a course     on local anesthesia.      This proposed pilot scale study will be a double-blind controlled trial using parallel     groups. As part of their usual anaesthesia course, the dental and dental hygiene students     will be practicing their inferior alveolar nerve injections on one another using 2% Lidocaine     1:100,000 epinephrine. Students who decide to participate in the study will be randomly     assigned to one of two groups: Group 1 will receive an injection of OraVerse (treatment     group), while Group 2 will receive an injection of sterile physiological water (control     group). The time required to the return of soft-tissue sensation and function will be     assessed using a questionnaire.   "
32423|NCT02861352|"     The purpose of this study is to determine the effect of a moderate decrease in dietary zinc     on DNA strand breaks and other cellular zinc biomarkers.   "
32424|NCT02861339|"     A retrospective study has shown the association between the inflammatory bowel diseases (IBD)     and the presence of a keratoconus. This new study will measure the prevalence of keratoconus     and follow its activity in patients affected by IBD and followed up in     hepatology-gastroenterology department at Nancy Hospital. The prevalence of keratoconus will     be compared to known data of literature about general population.      The secondary purpose is to search for a relationship between the presence of a keratoconus     and activity criteria of IBD.      Perspectives are a systematic screening for keratoconus in patients affected by IBD with the     amelioration of the ophthalmologic care of IBD patients and confirmation of the recent     hypothesis of inflammatory origin of keratoconus.   "
32425|NCT02861326|"     Aim: The aim of this study was to evaluate the relationship between initial probing depth     (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT)     in chronic periodontitis patients.      Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic     periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling     and root planing was applied in two sessions. Probing depth (PD), clinical attachment level,     gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites     were grouped according to their IPD and root number of teeth as single- or multi-rooted.   "
32426|NCT02861313|"     Comparing the quality of life and periimplant condition around a single implant retained     mandibular overdenture in two groups one will have a ball attachment and the other is having     a (CM-LOC) one.   "
32427|NCT02861300|"     This study has two portions. The main goal of the Phase I portion of this research study is     to see what doses of CB-839 and capecitabine can safely be given to patients without having     too many side effects. Other purposes of this research study will be to determine what side     effects are seen with this combination of medicines. The Phase II portion of the study will     test how many patients show shrinkage in their tumor with this combination of medicines and     what changes occur inside the cancer cells and blood cells after treatment.   "
32428|NCT02861287|"     This study aims to realize an economic evaluation of the introduction of Plerixafor in     addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed     or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF     alone.   "
32429|NCT02861274|"     OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio     inhibitory response to the head up tilt testing (HUT) evaluation.      METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without     asystolia (2A type) have been enrolled in this study. These patients have been studied by     electrophysiological study (ES). After ES patients have been differently treated     (interventional treatment group A, v/s drug therapy group), and followed up during 360 days,     to evaluate syncope recurrences.   "
32430|NCT02861261|"     The purpose of this study is to conduct a multicenter randomized, double-blind,     placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after     berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes   "
32431|NCT02861248|"     A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic     post-burn scars in an Asian population.   "
32444|NCT02861079|"     This study evaluates the addition of transcervical Foley catheter balloon and vaginal     prostaglandin E2 in induction of labor at term. Half of participants will be used combine     transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will     be used alone vaginal prostaglandin E2.   "
32432|NCT02861235|"     Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the     presence and severity of abnormalities of myocardial perfusion, as well as the extension of     infarction residua. However, actual imagery devices (gamma cameras) have low resolution and     detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection     sensitivity and could allow proportionally diminishing injected activities or recording     times. Only one pilot study has been recently published on this type of camera, the D.SPECT     camera.      This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2     to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The     purpose is to demonstrate the equivalence of images recorded by two camera types for     diagnostic information and the secondary purpose is to demonstrate the superiority of the     D.SPECT camera in terms of image quality.   "
32433|NCT02861222|"     The purpose of this study is to determine the toxicity and tolerance of Myocet® in children     and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20%     of the dose recommended for adults and a dose recommended for adults, administered in single     dose in 1-hour perfusion each 21 days.      Other purposes are to determine the recommended dose of Myocet and to assess the response to     drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite     doxorubicinol during 72 hours after Myocet administration will also be studied.   "
41645|NCT02740517|"     Trial to demonstrate that the intended user population can use the device unsupervised in the     home and collect data that is of sufficient quality to be successfully analysed for     respiration rate.   "
32434|NCT02861209|"     This study aims to develop, implement and evaluate a care pathway for patients with cancer     who are treated with oral anticancer drugs (OACD).      The care pathway will be developed in six hospitals in Flanders, and will be adapted to the     local setting and situation.      The investigators hypothesize that the implementation of a care pathway will increase the     quality of the drug therapy, the communication between health care professionals (HCPs) and     patients, and will lead to an improved level of self-management and adherence. Moreover, the     invesitgators hypothesize that the care pathway will facilitate the communication between     HCPs in the hospital setting and in ambulatory care, and will improve counseling skills,     self-efficacy and self-confidence of HCPs.      At the end of the study, a roadmap for the nation-wide implementation of a similar care     pathway will be constructed based on the experiences of the participating hospitals. This     roadmap will certainly include an e-learning platform for healthcare professionals.   "
32435|NCT02861196|"     This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular     invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment     model，then to clarify the probability of bladder preservation, corresponding cancer specific     survival, and the quality of life.   "
32436|NCT02861183|"     A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to     provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).   "
32437|NCT02861170|"     This study evaluates the effectiveness of a brief mindfulness-based intervention on     post-operative pain and disability among anxious patients with chronic pain undergoing total     hip arthroplasty.      All participants will receive an educational brochure and links to videos containing     strategies for coping with pain and anxiety. The half of the participants who are allocated     to the treatment arm will also receive a 10 minute mindfulness intervention called a body     scan.   "
32438|NCT02861157|"     The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based     technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes     disease- and treatment-related knowledge through interactive and game-based educational     materials; (b) support adherence to the treatment regimen through customized task prompts via     mobile and web-based delivery; and (c) promote patient-provider communication through     real-world data collection and feedback loops. Investigators will examine the effectiveness     of the Planet T1D mobile app and website in improving treatment adherence, disease-related     knowledge, transition readiness, condition management, and the psychological correlates of     these variables in youth with type 1 diabetes.   "
32439|NCT02861144|"     The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities is a randomized     control trial that will test the effectiveness of partnership incentives plus evidence-based     education to optimize glycemic outcomes among diabetic patients compared with usual care.   "
32440|NCT02861131|"     Substantial respiratory morbidity has been associated with postoperative residual paralysis,     which is fairly common after general anesthesia involving a neuromuscular blocking agent.     Common practice in United States is to reverse neuromuscular blockade with neostigmine at the     end of surgery. A new drug with evidence of more complete neuromuscular reversal has been     developed, sugammadex. The objective of this study is to determine if a strategy of     rocuronium neuromuscular reversal with sugammadex will reduce the proportion of subjects with     any postoperative pulmonary complication, compared to neostigmine.   "
32441|NCT02861118|"     The purpose of this study is to evaluate the impact of the co-morbidities profile on     treatment response in inflammatory bowel disease (IBD) patients.   "
32442|NCT02861105|"     The purpose of this study is to assess the efficacy of LMWH treatment in women with     unexplained infertility and negative immunological markers undergoing ICSI.   "
32443|NCT02861092|"     It exists recommendations to get an optimal antibiotic treatment for bone and joint infection     and prescription of antibiotics in the bone and joint infections on material meets certain     obligations: the micro-organism must be known, the antibiotic therapy must be started in     association, obtaining high plasma levels, use of molecules having good bone circulation. It     is recommended to initially administer treatment with intravenous route and to propose an     oral relay, under conditions. It is recommended to administer the antibiotic treatment for at     least 6 weeks.      The dosages of antibiotics are adapted to the weight of patients in order to respond to those     recommendations. But little is known about the optimal dose of treatment to give to obese     patients (BMI>=30) and the frequency of serious adverse events in these patients in which the     dosage is then higher can be more important compared to non-obese patients. The aim of the     study is then to evaluate the risk of occurrence of serious adverse events in obese patients     and to identify risks factors.      This study consists in a retrospective cohort of obese patients treated for a bone or joint     infection and having had a serious adverse event. Several data are collected concerning:     demographics data, treatment responsible of the serious adverse event (molecules, dosage,     route), description of the serious adverse event, residual rate for vancomycin.   "
32445|NCT02861066|"     Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately,     patients often face barriers to accessing mental health care, particularly psychotherapeutic     interventions, including long wait-times and demanding therapeutic protocols. For instance,     Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of     depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over     30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care.     The goal of this project is to test the effectiveness of an Abbreviated MBT (<10 hours of     clinical time and <10 hours of homework) in reducing symptoms of depression/anxiety and     improving wellbeing. If effective, this Abbreviated MBT could reduce barriers to accessing     mental health care.   "
32497|NCT02860390|"     This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old     individuals with persistent asthma comparing differing levels of texting interventions with     each other and with a usual care group. The two texting interventions include 1) texting only     the individual with asthma and 2) texting the individual with asthma and an important person     in that individual's life such as a parent or spouse. These two texting groups will be     compared to a group receiving usual asthma care at Denver Health.   "
42078|NCT02734862|"     The purpose of this study is to determine if intravenous CD101 is safe and effective in the     treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by     oral fluconazole).   "
32447|NCT02861040|"     The main purpose of this investigational research study is to determine how safe and     tolerable the study drug volasertib is in combination with liposomal vincristine (Marqibo; an     FDA-approved drug) in patients with relapsed/refractory acute lymphoblastic leukemia. While     VSLI demonstrated an overall response rate of 35% in Acute Lymphoblastic Leukemia (ALL)     patients that had failed to respond to or relapsed after chemotherapy, combining it with     other agents may increase clinical benefit.      Volasertib inhibits proteins involved in the cell cycle that are increased in ALL. When     volasertib inhibits these proteins ALL cells die. In the laboratory, volasertib has been     shown to increase activity of vincristine against ALL cells. Therefore, we think the     combination of volasertib and VSLI will be more effective against your leukemia than either     drug used alone. This study will try to find out what effects, good and/or bad, this drug     combination has on the patient and their cancer, and to find a dose that may be used in     future studies.   "
32448|NCT02861027|"     Due to the importance of the functions of the gluteus medium, mainly during gait, it becomes     essential to strengthening early in the musculature. The association of muscle strengthening     with the Functional Electric Stimulation (FES) comes to accelerate stabilization of hip,     leading to functional rehabilitation early and improves the quality of life through     rehabilitation in social life and activities of daily life. Thus, it becomes a relevant study     to assess objectively the implications of FES in muscle strengthening of gluteus medium     associated with the Physiotherapy Protocol Total Hip Arthroplasty (PPTHA), through the     assessment of motor performance in patients undergoing surgery for Total Hip Arthroplasty     (THA), aiming to better rehabilitation strategies for this population.      The objective of the research is to assess the effects of functional rehabilitation through     PPTHA associated with FES in the gluteus medium compared only with the PPTHA, in patients     undergoing surgery for THA.      The principal hypothesis is that there is difference between the functional rehabilitation of     the patients undergoing PPTHA associated with the FES of gluteus medium, after THA and the     patients submitted only to PPTHA.   "
32449|NCT02861014|"     The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to     assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting     Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a     Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4     weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72),     and a Follow-up period of at least 2 years.   "
32450|NCT02861001|"     Optical guidance for percutaneous tracheotomy in intensive care is usually performed by     bronchoscopy. Recently, an endotracheal tube with a camera mounted at its tip (VivaSight-SL)     has been introduced that allows for endotracheal visualization.      For feasibility evaluation, ten patients in intensive care receive percutaneous tracheotomy     with optical guidance by the VivaSight-SL tube. If this part is completed with satisfactory     results, patients are randomized to receive optical guidance by bronchoscopy or by     VivaSight-SL tube. The primary end point is the visualization through the tube camera of     endotracheal landmark structures for tracheotomy and visualization of the needle insertion     (according to score, see detailed description).   "
32452|NCT02860975|"     The purpose of this study is to define the safety and the biochemical-physiological response     of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.   "
32453|NCT02860962|"     A proof-of-concept study to determine the antidepressant potential of Dextromethorphan for     treating depression associated with Major Depressive Disorder in inpatients.   "
32454|NCT02860949|"     Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients     undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration     (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added     benefits of PCI using different combinations of local anesthetic agents. Therefore, the     investigator wanted to know the effectiveness of pain control in LAI with and without PCI.      Half of participants received LAI with PCI, while the other half received LAI without PCI     during total knee arthroplasty.   "
32783|NCT02856646|"     The purpose of this study is to gather data on patients diagnosed with and treated for     classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is     rendered, as well as assess the outcome of those treatment options and their impact on     quality of life. Additional analyses will also attempt to identify prognostic or predictive     biomarkers   "
32455|NCT02860936|"     ACC is rare and represent approximately 25% of salivary gland carcinomas. The standard     treatment is surgical excision followed by radiotherapy in selected cases. The disease is     characterized by a progressive course with local and distant recurrences. First-line     treatment is palliative chemotherapy that had modest results. Expression of the epidermal     growth factor receptor in ACC of salivary origin has been reported. Several papers report     that a high percentage of ACCs carries a chromosome translocation that results in the     overexpression of the oncogene MYB, which is involved in cell proliferation, apoptosis,     differentiation and in upregulation of several growth and angiogenetic factors contributing     to the autocrine activation of the FGFR and VEGFR-mediated angiogenesis. Recently two whole     genome sequencing of several ACC tumor/normal pairs have found mutations in genes involved in     the FGF/IGF/PI3K pathway corroborating the hypothesis that this subset might benefit from     inhibitors of this pathway. Based on these premises several antiangiogenic drugs and FGFR     inhibitors are currently under investigation and a response rate of 11% was observed in ACC.     Lenvatinib is an oral multiple RTK inhibitor targeting VEGFR-1-3, FGFR-1-4, RET, c-KIT, and     PDGFR. On February 13, 2015 the drug has been approved by FDA for the treatment of patients     with locally recurrent or metastatic, radioactive iodine-refractory differentiated thyroid     cancer. Based on preclinical and clinical data, the investigators believe that targeting     angiogenesis, FGFR pathway and tumor microenvironment might represent a rational basis to     test Lenvatinib in patients with relapsed and/or metastatic ACC.   "
32456|NCT02860923|"     This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.      The purpose of the study is to compare the change of body weight after 6 months treatment     with a lifestyle intervention + exenatide compare to the one after the same lifestyle     intervention+ placebo in adults patients suffering from a hypothalamic obesity due to     treatment of craniopharyngioma.   "
42079|NCT02734849|"     This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses.     Pharmacodynamic activity will also be evaluated.   "
32463|NCT02860832|"     Background and significance: Though the problem of bullying among adolescents is evidently     increasing and of a serious social concern, it is often undetected until serious outcomes     have surfaced. In recent years, along with the rapid expansion of the Internet, social     network services (SNS) and smart phones, cyber-bullying has been growing. Compared to the     traditional bullying, cyberbullying is unique in nature and potentially more hazardous in     terms of invisibility, lack of control, where it enables communication with a broad range of     people at any time and place.      To explore deeper understanding of the magnitude and the impact of the bullying among     adolescents in Taiwan to inform public policy and future health intervention programs may be     beneficial not only to Taiwan but also to Asia as a whole. Many Asian countries now suffer     the similar problems of bullying among adolescents, since these countries share similar     characteristics of development (spread of internet, SNSs and smart phones).      Goal and objectives: This study aims to explore Taiwanese adolescents' experiences,     perceptions, opinions and mental health regarding cyberbullying and traditional bullying to     inform the development of questionnaire in the quantitative phase of mixed methods study.      Study design: A qualitative study design with in depth interviews will be adopted.      Target population and study setting: Senior high school students will be recruited from     Taipei city, Taiwan.      Sample size and sampling method: Participants will be sampled by convenience sampling until     thematic saturation is attained, probably around 50 students.      Data collection: Face-to-face in-depth interview with semi-structured questionnaire will be     used.      Data analysis: All interviews will be voice-recorded, transcribed, analyzed by thematic     analysis procedure. Analysis process will include familiarization, coding, searching for     themes, reviewing the themes, defining, naming themes and writing up or weaving the analytic     narrative. Triangulation and supervision will also ensure credibility and balance in the     process.   "
32464|NCT02860819|"     This is a proof-of-concept study to define efficacy of gemcitabine, carboplatin and VELIPARIB     (ABT-888) in patients with refractory germ cell tumors (GCTs). PARP proteins are involved in     base excision repair (BER), one of the major DNA repair system in cells and PARP is     overexpressed in testicular GCTs (TGCTs) compared to normal testis and data suggest that PARP     overexpression is early event in TGCTs development. Patients with low PARP expression in     primary tumour had non-significantly better OS compared to patients with high PARP expression     (5-year OS 89.2% vs 78.7%; HR=0.50, 95% CI 0.21 to 1.17, p=0.12). The aim of this study is to     evaluate PARP inhibitor VELIPARIB in combination with gemcitabine, carboplatin in patients     with refractory germ cell tumors (GCTs).   "
32490|NCT02860481|"     FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the     diagnosis of cancer.      A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal     melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will     include n=10 patients per histological type except for breast cancer (n=50). 100 patients are     expected in this cohort.      A second cohort will explore the more promising histological type (if any) in term of     incidence of detection. 100 patients are expected for this second cohort.   "
32466|NCT02860793|"     The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned     to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and     CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia     (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to     convey promigratory and antiapoptotic signals into the cell and represents an independent     prognosis factor of survival in patients treated with induction chemotherapy. This study aims     at:        -  evaluating the impact of PTK7 expression on primary AML cells ex vivo        -  evaluating the diagnostic and prognostic value of a soluble form of PTK7   "
32467|NCT02860780|"     The main purpose of this study is to evaluate the safety of the study drug prexasertib in     combination with ralimetinib in participants with advanced or metastatic cancer.   "
32468|NCT02860767|"     The purpose of the study is to evaluate the concentrations of antibiotics used as empirical     treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee     prostheses   "
32469|NCT02860754|"     This prospective cohort study aims to determine whether the addition of the 6MWT to the RCRI     score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac     surgery. In addition, this study will assess whether the patients' reported MET score     corresponds to the determined MET score from the 6MWT distance completed.   "
32470|NCT02860741|"     Rural African Americans are disproportionately impacted by social stressors that place them     at risk for experiencing elevated depressive symptoms. This project will test the     effectiveness of a culturally adapted behavioral activation intervention (REJOICE) for use     within rural African American churches. Further, this project will gather data on strategies     necessary to promote the successful implementation of this intervention within rural African     American churches.   "
32471|NCT02860728|"     Structural changes in skeletal muscles of patients with chronic obstructive pulmonary disease     (COPD) have been linked to impaired muscle function, reduced exercise capacity, and increased     mortality associated with this disease. Muscle dysfunction also contributes to dyspnea     intensity and the ability to sustain exercise, making aerobic exercise training intolerable     at the intensity and/or volume required to achieve clinically important changes. Resistance     training (RT) is an attractive exercise modality because it is efficacious and more tolerable     initially. No work has examined whether a short-term RT program can reduce exertional     symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients with COPD.   "
32472|NCT02860715|"     This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study     designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7     in healthy volunteers.   "
32473|NCT02860702|"     A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in     infants with single ventricle physiology fed an exclusive human milk diet prior to, and     throughout the post-operative period following, surgical repair. Human milk is defined as     expressed human milk or donor milk and its derivatives, human milk-based fortifier and human     milk caloric fortifier.      The study hypothesis is that infants fed an exclusive human milk diet will have short and     long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes     while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).   "
32474|NCT02860689|"     Objective: To analyze the association between sexual function of men with spinal cord injury     with possible predictive factors for dysfunction.   "
32498|NCT02860377|"     Mother spend a large amount of time with their children. It is assumed that mother     contributes to their neurological development not only with visual stimuli, but also with     auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response     to the self-name being spoken by the mother than by a stranger. Therefore, investigators     suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten     the emergence from general anesthesia.   "
32475|NCT02860676|"     The purpose of the study is to investigate the safety of the investigational drug called     cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug called     a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on     the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and survival of     the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should target the     cancer cells. Cirmtuzumab is considered experimental because its use is not approved by     United States (US) Food and Drug Administration (FDA).      Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease the     number of CLL cells, the investigators do not know if this will work in humans. Therefore,     the goal of this study is to see if cirmtuzumab is safe and tolerable in study participants     when given for a duration of 6 to 12 months.   "
32476|NCT02860663|"     Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3     (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is     currently not scientifically established.      Objective: The aim of this study was to test the hypothesis that VitD3, 25OHD3 and VitD2     affected vitamin D status equally in humans and if rejected, to estimate the difference in     activity.      Design: This study was designed as a 3 x 6 weeks (with 4 weeks run-in) double-blinded     randomized cross-over study with 12 young, apparently healthy male volunteers and was     performed during wintertime at 55 degree N. during the 4 weeks run-in period all volunteers     received 10 ug/d VitD3 in order to achieve steady-state in vitamin D status. During the 3x6     weeks intervention periods the subjects received 10 ug/d VitD3, 10 ug/d 25OHD3 or 10 ug/d     VitD2 in random order. Content of vitD3, VitD2, 25OHD3 and 25-hydroxyvitamin D2 (25OHD2) in     serum were quantified my LC-MS/MS using 0.1 mL serum.   "
32477|NCT02860650|"     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and     Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.   "
32478|NCT02860637|"     In addition to the motor and sensory functions, sexual function changes after spinal cord     injury and is considered one of the most common problems, ranging from a decrease in sexual     desire to disturbances of erection, orgasm and ejaculation.      Objective: To assess the impact of the complexity of traumatic spinal cord injury in male     sexual function.   "
32479|NCT02860624|"     This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to     that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of     GERD.   "
32784|NCT02856633|"     The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE     Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti     Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital     signs and to detect the health conditions required by the competition.   "
32480|NCT02860611|"     Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s     while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell     auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an     association with T helper cells. In this study investigators aimed to investigate the     difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects.      The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used     oral antidiabetics but insulin before and 31 healthy subjects (CG).      Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)     levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were     compared with those in T2DPs and controls.   "
32481|NCT02860598|"     Anemia concerns a lot of patients with cancer and affects their quality of life (QOL).     Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating     agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin     level (Hb) and is a validated alternative to transfusion.      However, in hematology, if there are some specific recommendations for the use of ESAs in     lymphoid pathology, there are none for myeloid disorders and in the context of autografts and     allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are in     particular interested in both indications: treatment of anemia in acute myeloid leukemia     (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a     non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell     source.   "
32482|NCT02860585|"     The objective of this study was to evaluate the outcome of patients affected with different     subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and     autologous haematopoietic progenitor cell transplantation.   "
32483|NCT02860572|"     Background: After hypotension, oliguria (urine output less than 0.5 mL/kg/h) was the most     common trigger to administer fluid bolus in a multinational practice survey in intensive     care. The effect of fluid bolus on cardiovascular variables can be very short-lived among     patients in shock suggesting that fluid boluses in the optimization phase are unlikely to     improve patient-centered outcomes. Moreover, a growing body of evidence suggests a poor renal     response to fluid bolus.      Objective: To investigate, whether fluid bolus - as a standard of care - improves urine     output in oliguric patients compared to a non-interventional follow-up approach without fluid     bolus.      Design: Investigator-initiated, open, randomized, controlled study      Interventions:        1. Intervention group - follow-up without intervention        2. Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes)      Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and     sepsis      Trial size: 120 patients randomized in 4 ICUs   "
32484|NCT02860559|"     This is a study of stem cell transplantation with TBX-1400 in pediatric subjects with severe     combined immunodeficiency (SCID).      The donor cells are exposed to a protein that has been shown in the laboratory to improve the     ability of the donor cells to make blood and immune cells after transplant. Exposure of the     donor cells to this protein does not modify the genes in the cells in any way.      This study has two goals. The first goal is to find out if transplant with TBX-1400 is safe.     The second goal is to find out what effects TBX-1400 stem cells have on time to engraftment     in pediatric subjects with SCID. The study hypothesis is that TBX-1400 cells will shorten the     time to immune reconstitution after transplant.   "
32485|NCT02860546|"     A Phase 2 Study with Safety Lead-in, Evaluating TAS-102 Plus Nivolumab in Patients with     Microsatellite Stable Refractory Metastatic Colorectal Cancer   "
32486|NCT02860533|"     The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the     photoplethysmography signal of the inbuilt camera can measure blood pressure (BP)     fluctuations with sufficient correlation compared to the goldstandard oscillometric BP     measurements. Investigators will recruit patients who are scheduled for a routine treadmill     stress test and assess their blood pressure before and right after the test with the     smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced     BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR     DELTA BP Study is the correlation of the absolute difference of subsequent measurements     between both techniques. If the relative chances of BP fluctuations are sufficiently assessed     with this new device, BP fluctuations could be monitored continuously after calibration.   "
32487|NCT02860520|"     The retinitis pigmentosa (RP) are genetic conditions that cause retinal degeneration leading     to severe low vision and is the leading cause of consultation in reference centers dedicated     to the ophthalmic genetics. These rare diseases are characterized by a triple heterogeneity     (clinical, genetic and molecular), which made them unreachable by traditional molecular     diagnostic sequencing technology by the large number of genes to be tested (> 190).      The advent of high-throughput sequencing (NGS) and targeted capture has opened unexpected     possibilities of investigation and ultimately to improve the care of patients. This project     aims to study the genetic and molecular epidemiology of an interregional french (grand EST)     cohort of patients. Patients receive a detailed retinal phenotype (visual acuity, visual     field, photographs of the fundus and ERG). Their DNA will be analyzed by NGS targets the 190     known genes (https://sph.uth.edu/retnet/).      This research will provide a molecular epidemiological cohort study compared to prior     publications on the frequency of genes involved. The benefit for patients is important to:     establish a mode of transmission of the disease and optimize genetic counseling (currently     very empirical); establish phenotype-genotype correlations in the French population (very few     studies to date) and from the data of international literature; identify patients likely to     be included in future therapeutic protocols of research; identify patients with significant     potential for future projects to identify new genes.      The primary purpose of the protocol is to use high throughput sequencing to identify     pathogenic variants in genes involved in RP.      The secondary purposes will be the following:        -  Determining the diagnostic yield        -  Study the genotype-phenotype correlation.      The secondary purposes will be the following:        -  Determining the diagnostic yield        -  Study the genotype-phenotype correlation   "
32488|NCT02860507|"     The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep     neuromuscular blockaded (induced by rocuronium)   "
32489|NCT02860494|"     Tuberous sclerosis complex (TSC) is a rare genetic multisystem disorder characterized by the     development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and     skin in more than 90% of cases. Facial angiofibromas (FA), present in about 80% of patients,     are a stigmatizing hallmark of the disease. Everolimus could be a candidate for use as a     topical formulation to treat FA. This adaptive seamless Phase II/III study primary objective     is to determine the dose of topical everolimus for treatment of FA and evaluate the efficacy     and safety of topical everolimus versus placebo in patients with angiofibromas.   "
40444|NCT02756234|"     The objective of this study is to carefully monitor all patients undergoing Computed     Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the     efficiency of the CTP procedure in a community setting.   "
32491|NCT02860468|"     The compliance of participants in cranberry related clinical trial is poor due to the     bitterness and astringency of cranberry products. There is a pressing need for an effective     approach to verify participant compliance. The PLS-DA (Partial Least Squares Discriminant     Analysis) /OPLS-DA (Orthogonal Partial Least Squares Discriminant Analysis) models     established from the investigator's previous study provide an opportunity to identify     cranberry juice consumers. In this blinded, placebo-controlled, cross-over study,     investigators hypothesize that the established statistical models of PLS-DA (Partial least     squares discriminant analysis) /OPLS-DA (Orthogonal partial least squares discriminant     analysis) can identify cranberry juice consumers and non-consumers by analyzing the     metabolomic changes in blood and urine among young women. In order to further explore the     function of cranberry, microbiome profile will also be compared between cranberry juice     consumption and placebo consumption after long-term treatment. Another comparison of     metabolomic changes between short-term treatment and long-term treatment will be made to     further identify candidate biomarkers of cranberry consumption and explore the correlation     between acute effects and chronic effects of cranberry.   "
32492|NCT02860455|"     The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of     blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard     laboratory blood gas analysis (COHb) have reported contradictory results.      the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO     poisoning, enabling rapid detection and management of patients with suspected CO poisoning in     the prehospital emergency setting This study assesses the diagnostic value of pulse     CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital     management of patients with suspected carbon monoxide (CO) poisoning.   "
32493|NCT02860442|"     The overall goal for the study is to test the efficacy of a smartphone app which includes an     alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National     Guard members in the State of Ohio who meet criteria for at-risk drinking in the previous 3     months. The main hypothesis is that those in the SP-BI group with have reduced frequency and     intensity of at-risk drinking and fewer binge drinking episodes.   "
32494|NCT02860429|"     The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on     gastrointestine carcinoma.This trail is randomized controled.Patients are diagnosed     gastrointestinal cancer based on pathology or cell biology.They are randomized into 2     groups:both groups receive Oxaliplatin regimen.The treatment group receives Cinobufotalin     20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven     days in addition to the chemotherapy.The control group only receive the same chemotherapy     with the treatment group.Both group have the same adjuvant therapy.Mainly to study of     oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve     toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug     toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory     cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.   "
32495|NCT02860416|"     The purpose of this study is to collect additional Investigational cognitive tasks and     additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).   "
32506|NCT02860273|"     In this study the investigators will determine whether the use of High Flow Nasal Cannula     Oxygen during test enhances exercise performance in COPD patients on a treadmill.   "
32499|NCT02860364|"     Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic     surgeries to be performed safely. Hypothermic circulatory arrest provides protection to     cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during     surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these     consequences, a trend towards warmer core body temperatures during circulatory arrest has     emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C)     hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the     length of cardiopulmonary bypass time and other key measures of morbidity and mortality.   "
32500|NCT02860351|"     In the present study, the cross-sectional area of subclavian vein, the distances of     subclavian vein ~ subclavian artery and subclavian vein ~ pleura are assessed in different     head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous     breathing adults.   "
32512|NCT02860195|"     A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine     the presence of vapor of alcohol in insensible perspiration.      One of possible application would be a continuous and non invasive monitoring of drinking     behavior. To investigate the validity of this method, it's necessary to compare Transdermal     Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations     and breath Alcohol Concentrations provided by reference methods.      The purpose of this study is to identify the kinetic of alcohol concentration in blood,     exhaled air and sweat after alcohol ingestion.   "
33192|NCT02851316|"     Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term     outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is     unclear if WBV influences athletic tasks such as running. The purpose of this study is to     evaluate the influence of WBV on running biomechanics in individuals with ACLR.   "
32501|NCT02860338|"     This retrospective study is a more extensive, confirmatory analysis of the cognitive and     functional outcomes initially seen in 2 groups of MCI/dementia patients in Springfield, MA     and compares specialized dementia care and a comprehensive treatment approach versus usual     care delivered in a non-specialist setting.      The first group of patients (n= 328) was seen by a dementia specialist, who utilized a     standardized assessment and treatment protocol (CNS). This included comprehensive     identification and treatment of hypoxia, sleep-disorders, and other cognitively-impairing     metabolic conditions as well as maximally- dosed FDA-approved medications for dementia,     depression, and PBA.      The second group of patients (n= 280) was seen by non-dementia specialists in the community     and received usual care which did not include comprehensive assessment or treatment of     underlying metabolic derangements or maximal utilization of currently available medications.      This study, evaluating date from a larger cohort (n>800) of specialist-treated     cognitively-impaired patients, will further examine the hypothesis that a comprehensive     dementia treatment protocol yields cognitive stabilization and/or improvement using already     available dementia drugs when compared with usual community care.   "
32502|NCT02860325|"     Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS)     and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive     pressure (barotrauma), excessive gas delivery (volutrauma) or inadequate volume     (atelectrauma). Asynchrony between patient efforts and ventilator support increases patient     discomfort, favouring fighting the machine, and increases the risk of air trapping and lung     overdistension even in patients with non-invasive ventilation (NIV).      Recently, a new modality of synchronization has been available for pediatric and neonatal     use: the neurally adjusted ventilatory assist (NAVA), which uses the diaphragmatic electrical     activity (Edi) as a signal to start the rise in pressure of the ventilator, and to adjust the     tidal volume and the inspiratory time (cycling off) to the patient needs, breath by breath.      The aims of this study are to know whether NIV-NAVA compared to unsynchronized modalities     (nCPAP/nIPPV), in infants born < 32 weeks GA with respiratory distress syndrome or requiring     prophylactic NIV (immaturity, apnoea) reduces systemic inflammation, measured by serum     cytokines concentration, reduces the need for oxygen and respiratory support, and if it     increases the probabilities of survival without bronchopulmonary dysplasia (BPD).   "
32503|NCT02860312|"     Patients on chronic hemodialysis present severe physical dysfunctioning associated with a     significant reduction of their muscle mass. These two parameters are associated with     increased morbidity and mortality along with deconditioning and poor quality of life. There     are several studies- usually short term, single center uncontrolled and underpowered- that     have shown a significant improvement of the physical, metabolic and dialytic parameters.      There are only few studies that have measured the impact of a long term intradialytic     exercise intervention on a supervised manner. This is a multi-center controlled study     examining the effects of intradialytic cycling on parameters of physical functioning, body     composition, cardiovascular and nutritional status, immunological status and quality of life     in a group of clinically stable hemodialysis patients   "
32504|NCT02860299|"     In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no     leakage of the lock into the bloodstream should have been seen. Lock leakage could have     particularly serious, and especially clinical, repercussions in these patients who already     have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this     study is to investigate the leakage of locks into the bloodstream by measuring, before and     after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings     will complete safety data already collected in the VERROU REA study.   "
32505|NCT02860286|"     This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat     800 mg two times a day (BID) administered orally. Screening of subjects to determine     eligibility for the study will be performed within 21 days of the first planned dose of     tazemetostat.      In Part 1, 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1     status will be treated and undergo pharmacokinetics (PK) blood sample collection after a     single tazemetostat 800 mg.      Part 2 will include subjects with BAP1-deficient relapsed or refractory malignant     mesothelioma.      Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or     withdrawal of consent, or termination of the study. Response assessment will be evaluated     after 6 weeks of treatment and then every 12 weeks thereafter while on study.   "
32507|NCT02860260|"     The aim of this study is to show for the first time that treatment with intravenous     fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases     in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.      The analysis of the recovery of functional and cognitive abilities as well as mood at 3     months will allow us to study the impact of BDNF on these parameters. Thus, depending on the     results obtained, circulating BDNF could serve as an early marker of these.   "
32508|NCT02860247|"     This study aims at determining within a short time (<3h) the susceptibility to clinical     isolates of E. coli to the major antibiotics directly from positive blood cultures.   "
32509|NCT02860234|"     This study is designed to test the efficacy of tailored operative or non-operative management     (NOM) for MRI defined low-risk rectal cancer following neoadjuvant intensity modulated     radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main purpose of this     study is to increase organ-preservation rate for low-risk rectal cancer patients.   "
32510|NCT02860221|"     The purpose of this study is to compare the blood loss of intravenous and topical     administration of low dose epinephrine plus combined administration of intravenous and     topical tranexamic acid for primary total knee arthroplasty.   "
32511|NCT02860208|"     The objective of this prospective clinical study was to evaluate the 3-year outcomes of     anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant     therapy (SPIT) programme was followed.   "
33820|NCT02843113|"     Through Stepping Up 4 Your Child, non-custodial fathers will be provided with a     comprehensive, solution-oriented program featuring group based parent education and     individualized case management to help them achieve financial independence, increase their     parenting skills, and develop a co-parenting alliance.   "
32513|NCT02860182|"     Acute type A aortic dissection is a frequent (3 cases per 100 000 people per year) and severe     (spontaneous mortality 70%), needing an emergency surgical treatment. Surgical outcomes have     improved with the development of surgical techniques, but the postoperative mortality remains     high (15-30% at 30 days). Endovascular approach with the deployment of endoprosthesis sealing     the proximal intimal tear is an attractive minimally invasive technique, which can represent     an alternative to surgical repair especially in high risk patients.   "
32514|NCT02860169|"     This study aim to adapt and test a novel indication of motivation in participants with cold &     flu using the Picture Surfing Task (PST). The purpose of this task, in both healthy     participants and those with cold & flu, will be to provide a measure of: 1) change in general     motivation, 2) change in cold and flu-specific motivation, and 3) any change in general     tendency to exert force to serve as a control.   "
32515|NCT02860156|"     This is a multicenter clinical trial of a cross section of HIV+ patients with and without     diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100     HIV+/DD+ & 100 HIV+/DD-) will be enrolled. This study will evaluate biomarkers, phenomapping,     metabolomics, cMRI, echocardiography to determine characteristics unique to this patient     population.   "
32516|NCT02860143|"     A. Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to     adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare the     time of capture of respiratory events (depression, arrest, etc…) on both the RVM and the     capnograph C. Compare the incidence of missing or poor quality readings between the RVM and     the capnograph D. Compare RR readings between the RVM and the capnograph (during periods with     adequate data quality on both devices) E. If RMV can identify respiratory obstruction.     Capnography   "
32517|NCT02860130|"     The purpose of this research is to determine if an investigational new drug solution called     Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous     renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18     as the anticoagulant will be compared to patients who receive CRRT treatment with no     anticoagulation.   "
32518|NCT02860117|"     The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in     the control of pain intensity, the impact on the consumption of opioids and observe the side     effect profile in patients suffering from great extent of burns.   "
32519|NCT02860104|"     The investigators will perform this study to prospectively analyse the clinical outcome after     percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound     (US) guidance.   "
32520|NCT02860091|"     The main objective of this proposed investigation is to evaluate blood ropivacaine     concentrations in infants and toddlers following the initiation of, and over the course of,     continuous paravertebral nerve blockade using ropivacaine infusion for postoperative pain     control following esophageal atresia repair procedures that include posterior tracheopexy.      Continuous paravertebral infusion of ropivacaine is the current standard of practice for this     surgical population at the investigators' institution and, as such, this study does not aim     to alter the current standard clinical care received by participants but rather evaluate the     blood concentrations of ropivacaine as it is routinely used.   "
32521|NCT02860078|"     Qualitative and quantitatively evaluate the pain control and incidence of adverse effects in     patients undergoing corticosteroid infiltration and local anesthetic through sacral epidural     puncture with ultrasound assistance or isolated use of fluoroscopy to aid puncture and     location of the sacral epidural space. A group will be submitted to epidural corticosteroid     infiltration associated with local anesthetic with the use of fluoroscopy for locating the     sacral epidural space, which is currently the gold standard for this technique, while in     another location group will be held with the use of ultrasound.   "
32522|NCT02860065|"     The purpose of this study is to compare the effect of low and high dose CPC-201 on brain     function including cerebral acetylcholinesterase (AChE) activity measured by positron     emission tomography (PET).   "
32523|NCT02860052|"     This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be     conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea     pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the     interdigital areas and all affected and immediate surrounding areas of one or both feet once     daily for 2 weeks, followed by a 4-week post-treatment observation period.   "
32526|NCT02860013|"     There are two main aims in this study. The first objective is to evaluate whether a     particular telehealth solution, in addition to standard treatment and care, lead to a     significant decrease in the mortality and an increase in health related quality of life for     patients suffering from Heart Failure that may benefit from telehealth compared with only     standard treatment and care. The second objective is to examine the additional costs of the     telehealth solution and assess whether this solution is a cost-effective way to care for     patients with Heart Failure across patients and municipality districts.      It is hypothesized that telehealth care will increase patients quality adjusted life years     compared to usual practice, since no difference in mortality and a higher health related     quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in     the number of admissions and readmissions to hospitals and a 30% reduction in the number of     outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to     whether these savings are offset by other costs such as more visits to general practitioners,     community care or the implementation costs.   "
32538|NCT02859857|"     The objective of this study is to characterize the safety profile and determine the maximum     tolerate dose (MTD) of BXQ-350, when given as a single agent at escalating doses, according     to the investigational product (IP) related dose-limiting toxicities (DLTs) in patients with     advanced solid tumors. Secondarily to assess the preliminary antitumor activity of BXQ-350 in     solid tumors and recurrent high grade gliomas.   "
32527|NCT02860000|"     This phase II trial studies how well alisertib with or without fulvestrant works in treating     patients with endocrine-resistant breast cancer that has spread to other places in the body.     Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of     estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving     alisertib with or without fulvestrant may be better in treating patients with breast cancer.   "
32528|NCT02859987|"     Peripherally Inserted Central Catheter (PICC) are intravascular devices used on patients     undergoing IV therapy. Insertion of these catheters can be achieved either by using the     anatomical landmarks for the veins or using ultrasound guidance. The guidelines recommend the     use of ultrasound guidance for central venous access catheterization to facilitate central     venous cannulation (CVC) and to reduce the risk of complications, but the scientific evidence     is limited and heterogeneous.      This is a prospective randomized clinical trial in adults patients requiring peripherally     inserted central catheter (PICC) placement for intravenous therapy.      The principal aim of this randomized clinical trial is to evaluate the effectiveness of     ultrasound-guidance technique for successfully peripherally central venous catheterisation in     the first attempt versus landmark method, in the context of PICC cannulation.      Patients are randomized (1:1) in two groups: Control arm (landmark technique) versus     Experimental group (ultrasound guidance technique). In order to avoid expected biases the     investigators stratified the cases by difficulty for venous cannulation. Crossover was     allowed if catheterisation could not be reached after two unsuccessful venipunctures, to     prevent suffering of the patients and troubles in its care.   "
32529|NCT02859974|"     Paradoxical Vocal Fold Motion Disorder (PVFMD), otherwise known as vocal cord dysfunction     (VCD) is a laryngeal breathing disorder that has several potential causes. In some     individuals, exertion is the predominant trigger. PVFMD can present like an asthma attack,     but asthma medication is ineffective in treating it. The effects of untreated PVFMD can be     devastating, leading to harmful, invasive, and ineffective treatments over a period of years.     Numerous anecdotal reports indicate that several behavioral techniques, may be surprisingly     effective and even curative. However, data are lacking. The form of respiratory retraining     technique tested in the current study educates people with PVFMD about breathing and teaches     them a number of breathing exercises specially designed to restore normal breathing patterns.      This case series study will use a dyspnea perception questionnaire, patient daily logs, and     physiological measurements of heart rate and breathing to examine whether this form of     therapy can improve exertion-induced PVFMD symptoms.   "
32530|NCT02859961|"     This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and     tolerability of the strategy of shifting clinically stable patients receiving suppressive     combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression     for 48 weeks following study entry.      Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140     monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing     retroviral regimen and PRO 140 at the beginning of the study treatment and also one week     overlap at the end of the treatment in subjects who do not experience virologic failure.   "
32531|NCT02859948|"     Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and     best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.   "
32532|NCT02859935|"     The purpose of this randomized controlled intervention study at the STI outpatient clinic of     Amsterdam is to answer the following questions : Does a personalised behaviour intervention     comprising of targeted in-depth screening on mental health problems and drug use and, in case     identified, subsequent linkage to care increase help seeking behaviour, and decrease risk     behaviour in MSM who are at high risk for STIs and HIV?   "
32533|NCT02859922|"     The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal     Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the     LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in     their structural design.   "
32534|NCT02859909|"     The main purpose of this study is to assess the efficacy and safety of BT595 in adult     subjects with chronic ITP. The primary objective of this study is to determine the rate of     subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at     least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at     least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in     addition to further efficacy assessments, are to evaluate the safety of BT595.   "
32673|NCT02858102|"     This study aims to develop a program of systematic physical exercise maintained for at least     12 weeks to normalize biomarkers of metabolic syndrome; improve neurocognition and social     functioning; increase empowerment, self-esteem and self-efficacy and reduce self-stigma in     individuals with severe mental disorder with metabolic syndrome.   "
32536|NCT02859883|"     The monitoring and prognosis of patients with familial polyposis adenomatous rests on     analysis of the transitional mucosa at the anal margin and especially on the tracking,     characterization and resection of lesions of dysplasia type of high grade at the duodenal     level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are     used. The FUSE technology allows the simplification or even the improvement of patient     surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a     second screen to enlarge the field of view may allow both analysis of duodenum and the main     and accessory papilla with one single endoscope and to decrease the number of omitted lesions     .   "
32537|NCT02859870|"     The coloscopy is considered as the gold standard for screening and resection of colorectal     adenomas. However the literature reports that the rate of omitted adenoma is still high (24     to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view     with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre     has demonstrated the feasibility with a significant improvement of the rate of detected     adenomas. This first study in France concerning this technology has the objectives to     demonstrate the feasibility in France, the safety and to compare the rate of detected     adenomas with data of the literature.   "
32539|NCT02859844|"     Many patients with neurological diseases suffer from neurogenic lower urinary tract     dysfunction (NLUTD), which often severely impairs quality of life, due to urinary urgency     with or without incontinence and voiding dysfunction. In addition, the upper urinary tract     may be jeopardized because of high intravesical pressure caused by detrusor overactivity with     concurrent detrusor-sphincter-dyssynergia and/or low bladder compliance. The treatment of     NLUTD is a challenge since conventional conservative therapies often fail and more invasive     treatments such as intradetrusor onabotulinumtoxinA injections, bladder augmentation and     urinary diversion have to be considered. Neuromodulation therapies including tibial nerve     stimulation (TNS) may be alternative non-invasive treatment options. Indeed, TNS is an     effective and safe treatment for idiopathic overactive bladder proven in randomized     controlled trials (RCTs), but its value in neurological patients is unclear. In a recent     systematic review, the investigators found evidence that TNS might become a promising     treatment option for NLUTD, however, more reliable data from well-designed RCTs are urgently     needed to reach definitive conclusions. However, the investigators study will be the first     adequately sampled and powered, randomized, placebo-controlled, double-blind trial assessing     transcutaneous TNS (TTNS) for NLUTD. This trial will provide significant insights into the     efficacy of TTNS in patients suffering from NLUTD and in the case that this treatment is     really effective in the neurological population, the investigators findings would completely     revolutionize the management of NLUTD in daily clinical practice. Moreover, this     interdisciplinary trial will relevantly influence the neurological and urological approach in     the management of NLUTD promoting future collaborative projects improving patients' medical     care and underlying the pioneering role of Switzerland in the rapidly developing and     ambitious research field of neuro-urology.   "
32540|NCT02859831|"     Fusarium are microscopic filamentous fungi that live as saprobiontics in outside     environments. They are found in the soil, the air, in water and on numerous plants. The     frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most     frequent invasive mycoses. Most cases have been reported in the United States, in France, in     Italy and in Brazil. A few epidemiological studies have shown the role of water in the     appearance of mycoses in highly immunodepressed patients. Few studies have focused on the     role of water in the transmission of mycoses in hospitals. The aim of this prospective study     is to describe, in time and pace, the contamination by Fusarium sp. in the water of two     different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major     works (reconstruction of a hospital). In each hospital, one reconstruction site will be     compared with a site not under reconstruction (control).      Water samples will be taken from the rooms of hospitalized patients.   "
32541|NCT02859818|"     Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary     management of type 1 diabetes for adolescents, favoring their adherence and improving their     quality of life and metabolic control. Six pediatric diabetes teams have engaged in action     research to build a regional ETP program based on social cognitive theory of Bandura,     assuming that the learning strategies of theory, applied in ETP program, should strengthen     self-efficacy of adolescents with type 1 diabetes, which could induce an improvement     behaviors adherence, quality of life and physiological profile of participants about 6 months     post-inclusion in the program.      Aims: The main objective is to describe the evolution over 6 months of self-efficacy in a     cohort of adolescents with type 1 diabetes who followed a therapeutic education program based     on social cognitive theory of Bandura in region PACA (ETPACAP program). Secondary objectives     are to describe the evolution of 6 months of glycemic control, behavior of adherence, quality     of life and other components of social cognitive theory for this population, to explore the     effects of socio-cognitive profile on adherence, quality of life and glycemic control among     adolescents with type 1 diabetes followed this program.      Method: A prospective multicenter cohort study of adolescents with type 1 diabetes who     participated in ETPACAP program, consisting of three components:        -  A quantitative component: collection and analysis of changes over 6 months of          self-efficacy, adherence, quality of life and HbA1c levels (ANOVA repeated measures);        -  A qualitative component: interviews with 32 participants at M0, M3 and M6 on the          socio-cognitive factors according to Bandura (analysis continues theming);        -  An integrative component, exploring the effects of the components of social cognitive          theory on adherence, glycemic control and quality of life of adolescents with type 1          diabetes cohort.      Expected results: This research is expected to bring new knowledge about the ETP programs and     the adolescent cohort studied to make an improvement and adjustment of educational sessions     relevant to the needs and expectations of this population.   "
32542|NCT02859805|"     The objective of this study is to validate a diagnostic tool severity of these common     non-motor manifestations, disturbing and little recognized as a self-questionnaire. This     assessment tool used on different subgroups of patients (free from any treatment at an early     stage of the disease and the stage of motor complications) will better understand the natural     history of the non-motor fluctuations (FNM)   "
32543|NCT02859792|"     The study will be conducted in two steps:        1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel        2. Estimation of the probability of response associated to the MED.      Each step has a main objective:      Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients     with chronic SCI      Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve     spasticity vs placebo, in patients with chronic SCI.   "
32554|NCT02859649|"     According to the working memory model, which accounts for the organisation of working memory,     the processing of non-meaningful gestures is not clear. Some authors suggest that working     memory for non-meaningful gestures has the same characteristics as the phonological loop,     made up of a phonological store and of a revival process (articulatory rehearsal). These     characteristics are evidenced in memory span tasks, memory span which is itself determined by     the duration of the memory trace and the time required to refresh the trace by subvocal     rehearsal.      The investigators therefore aim to set up a gestural working memory task, which is specific,     simple and reproducible, in the manner of verbal and visuospatial span tasks. It will first     be an exploratory and descriptive study with healthy subjects.   "
32555|NCT02859636|"     The main objective is to evaluate the pronostic value of endothelial dysfonction in acute     heart failure on a combined criteria associating cardiovascular mortality, nex     hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2     month and 1 year before acute heart failure.   "
32544|NCT02859779|"     Background: In type 1 diabetes, adolescence is often associated with deterioration in     glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment     compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to     insulin. Therapeutic patient education (TPE) is the key to successful management of the     disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the     Mediterranean region in France, and the care teams implementing them wish to promote joint     reflection with sick teenagers and families to identify needs and expectations of everyone on     priority skills to develop, to promote better management of the disease and improved quality     of life.      Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be     developed during the educational sessions, to promote self-management of their disease and     their treatment.      Method: Four audio-recorded focus groups will be organized in all 10 clinical settings     (adolescents, parents and health professionals). Thematic analysis will be carried out from     the transcript of the focus groups.      Expected results: The results will allow a joint reflection involving the participation of     young patients, families, health professionals and the research team to build and implement     new educational sessions that meet the identified needs. This action resulting from the     research is expected to pool resources in different health facilities providing therapeutic     education programs and to harmonize practices.   "
32545|NCT02859766|"     This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of     free and vascular endothelial growth factor (VEGF)-bound abicipar following single and     multiple intravitreal injections of abicipar pegol in treatment-naïve patients with     neovascular age-related macular degeneration (AMD).   "
32560|NCT02859571|"     This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor     at term. Half of participants will be taken continuous oxytocin, while the other half will be     taken intermittent oxytocin.   "
32561|NCT02859558|"     The study is being done to:        -  start ART early in those recently or acutely infected with HIV-1        -  see how starting ART as soon as the infection is found affects the amount of HIV-1 in          blood and how well the body fights the HIV-1 infection        -  look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells          (infection-fighting cells in blood) after 48 weeks of ART        -  see how early treatment for HIV affects the numbers of HIV-1 infection fighting cells          (CD4+ and CD8+ T-cells) in blood   "
32546|NCT02859753|"     To date, the majority of studies that have evaluated the efficacy of microwave ablation (MWA)     in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and compared     its efficacy with that of percutaneous radiofrequency ablation (RFA) for local recurrence and     survival have been retrospective. There have been no prospective randomized studies comparing     percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume, the response after     one session, local recurrence rates in the first year, complication rates and survival at 3     and 5 years for HCC lesions > 2 cm in patients with Child-Pugh A and B cirrhosis. The     hypothesis the investigators wish to explore is that though the 2 methods are equivalent for     lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for lesions > 2 cm and for     lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.   "
32547|NCT02859740|"     The objective of this study is to demonstrate the validity, the reproducibility and the     coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM)     mobility scale questionnaire in adults with lower-limb amputations.   "
32548|NCT02859727|"     This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor, to     the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI that already     participated to the CDZ173X2201 study. The study is open-label designed to establish the     long-term safety, tolerability, efficay and pharmacokinetics of CDZ173 in the target     population.   "
32549|NCT02859714|"     Previous studies have shown geographic disparities in the detection of colorectal adenomas in     Côte-d'Or, with an impact of the distance from the general practitioner and an ecological     deprivation index (EDI). On the other hand, the extremely low detection rates for these     lesions in everyday practice before the implementation of organized screening for colorectal     cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce     socio-geographic inequalities in access to care and prevention. Yet, participation in     screening also varies depending on the socio-economic level. In this context, the Côte-d'Or     Polyps Registry, the only body to have data for the pre-screening period (before 2003), will     make it possible to determine whether the implementation of organized screening led to the     elimination of socio-geographic disparities concerning the detection of adenomas.   "
32550|NCT02859701|"     Single-centre, randomised, double blind, placebo controlled, single ascending dose study. The     study will comprise of 2 parts: Part A (Cohorts 1 and 2); Part B (Cohorts 3 to 8).   "
32551|NCT02859688|"     Like genetic mutations, DNA methylation anomalies or epimutations can disrupt gene expression     and lead to human diseases.      However, unlike genetic mutations, epimutations can in theory be reverted through     developmental epigenetic re-programing, which should limit their transmission across     generations. Following the request for a parental project of a patient diagnosed with     Silver-Russell syndrome (SRS), and the availability of both somatic and spermatozoa DNA from     the proband and his father, we had the exceptional opportunity to evaluate the question of     inheritance of an epimutation. We provide here for the first time evidence for efficient     reversion of a constitutive epimutation in the spermatozoa of an SRS patient, which has     important implication for genetic counseling.   "
32552|NCT02859675|"     This study will improve our understanding of the mechanisms underlying anorexia in persons     with Crohn's disease flare-ups. The practical spin-off from this research is potentially very     important for the management of nutritional disorders associated with the disease by guiding     diets towards foods that correspond to patients' preferences and/or to modified tastes. In     addition, the results could lead to the identification of sensory markers that herald an     inflammatory flare-up of the disease.   "
32553|NCT02859662|"     It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment     syndrome.      the aim of this study is to assess the qualities of a predictive score on the occurence of     this syndrome after surgery of ruptured aortic aneurysm   "
32556|NCT02859623|"     Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease characterized by an     aggressive clinical behavior and a poor prognosis. It predominantly affects elderly males     with an average age of 67 years at diagnosis and the affected organs are usually the skin,     bone marrow, lymph nodes and the central nervous system. Patients with BPDCN have poor     outcomes with median overall survival (OS) ranging in the largest series of patients from 8     to 12 months.      Patient care must be defined in this pathology. Despite 40%-90% complete remission (CR) rates     after initial chemotherapy, relapses are almost inevitable.      The investigators have developed a national network to collect clinical and biological data     of French patients diagnosed with BPDCN.   "
32557|NCT02859610|"     research on interactions between portal hypertension and microparticles   "
32558|NCT02859597|"     This study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate     morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.   "
32559|NCT02859584|"     A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis     (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum     cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of     decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol     (SalivCort) in SAH.      Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were     measured   "
32562|NCT02859545|"     Chronic pain is a highly prevalent and costly health care problem. Yet, little is known about     the optimal ways for health care providers and family members to respond to the distress     expressed by people with chronic pain. The aim of the current study is to compare two models     of responsiveness to identify responses that result in better functioning and adjustment. An     experimental design will be used to test the extent to which emotional validation (e.g., an     empathic response to distress) increases or decreases pain behaviors during physical     activity. Romantic partners of individuals with chronic pain will be randomly assigned to     receive validation or control training. Following training, people with chronic pain and     their partners will engage in a discussion about pain and complete household tasks to examine     the effects of partner training on communication, pain intensity, and pain behavior.     Additionally, each individual in the couple will complete self-report measures after the     discussion, after the household tasks, and one-month following the laboratory visit.   "
32563|NCT02859532|"     Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus     within the venous system, mainly the lower limbs. The clot structure directly influences both     its location, but also its progressive profile expansion material or regression and embolic     migration.      Few data are available regarding the evolution of structural properties of thrombus after an     acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into     fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how     the thrombus responds to forces which it is subjected.      Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to     study its evolutionary properties.   "
32564|NCT02859519|"     The primary objective of this study is to evaluate the efficacy of topical MOB015B in     patients with mild to moderate distal subungual onychomycosis (DSO).      The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to     moderate DSO.   "
32565|NCT02859506|"     Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver     transplant but no study has been conducted to show eventual disturbances after the     transplantation able to explain modifications in eating behaviour. In parallel, the metabolic     status, itself dependent on liver metabolism, influences food preferences and is modified     after the transplantation as the liver recovers its ability to store glycogen, but is not     able to inform the brain as the afferent nerve impulses have been suppressed. The innovative     aspect of this project is to provide information on the importance of the liver in the     regulation of energy homeostasis.      The results of this study will improve our understanding of eating behaviour and     olfactogustatory sensitivity and allow us to orient liver transplant patients towards     appropriate diets.   "
32566|NCT02859493|"     This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on     improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a     randomized, double-blind, placebo-controlled study. The administration of yeast will be local     (vaginal).   "
32567|NCT02859480|"     This study is a prospective, randomized, open-label, single-center trial designed to compare     the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL)     rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary     intervention with the newer drug-eluting stent.   "
32568|NCT02859467|"     Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for     Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS).      Study Design: A single-blind randomized controlled trial was conducted on patients with FMS.      Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an     experimental group receiving kinesio taping and inhibitory treatment techniques, or to a     control group for exercises and electrical stimulation therapy.   "
32597|NCT02859090|"     It has recently been shown that various HSPs are strongly expressed in B lymphomas. Indeed,     HSP90 stabilizes the protein Bcl-6 in diffuse large-cell B lymphomas. Pharmacological     inhibition of HSP90 in vitro induced apoptosis in lymphoma cells (Cerchietti et al. Nat.     Medicine, 2009, 1369-1376). In addition, HSP110 is strongly expressed in non-Hodgkin     lymphomas, and targeting this HSP at the cell surface using specific antibodies could     constitute a future therapy (Zappasodi et al. Blood, 2011, 4421-4430). Despite the importance     of these proteins in the development of lymphomas, their expression and their role in the     activation of normal B lymphocytes and the normal development of germinal centres is not     known.      The expression of Heat shock proteins should vary among the different B lymphocyte     populations present in the tonsils (naïve B cells, memory B cells, germinal centre B cells).      The aim of this study is to establish an expression profile for heat shock proteins in     populations of B lymphocytes in human tonsils   "
32598|NCT02859077|"     BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in     patients who had NSCLC with EGFR mutations. In the study, the investigators want to use     EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both     EGFR mutation and BIM deletion polymorphism.   "
32569|NCT02859454|"     Background:      Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus.     It can cause voice changes, airway compromise, pulmonary lesions, and cancers. PD-L1 is a     protein on cells. It may be able to stop or decrease the immune system s response to viruses     such as human papillomavirus. The drug Avelumab interferes with the activity of PD-L1.     Researchers want to see if Avelumab treats RRP and study its side effects.      Objective:      To see if Avelumab works in treating RRP and is safe.      Eligibility:      People ages 18 and older with aggressive RRP that has not responded to available treatments      Design:      Participants will be screened with:      Medical history      Previously collected tumor tissue      Physical exam      Blood, urine, and heart tests      Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx,      and upper windpipe.      Before starting treatment, participants will have:      Endoscopy under anesthesia. A sample of papilloma will be taken.      Voice handicap questionnaire      CT scans      Apheresis: An IV is inserted into an arm vein. White blood cells are separated      from the rest of the blood and stored for research. The rest of the blood is returned      through the same IV or one in the other arm.      Participants will get the study drug by IV every 2 weeks for up to 12 weeks.      Participants will repeat the previous tests throughout the study.      If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then     every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses.      Participants will be evaluated 30 days after their last infusion. They will then be contacted     annually.   "
32570|NCT02859441|"     Objective: Von Hippel-Lindau (VHL) disease is an autosomal dominant heritable disorder in     which multiple benign and malignant neoplasms and cysts of specific histopathologies develop     in the kidney, adrenal gland, pancreas, brain, spinal cord, eye, inner ear, epididymis and     broad ligament. The disease affects about 7,000 individuals in the United States. Retinal     capillary hemangiomas (RCH) are the most common and often the earliest manifestation of VHL     disease and may lead to significant vision loss. In some such eyes, inexorable progression of     RCH leads to blindness and phthisis bulbi despite aggressive treatment. Levels of vascular     endothelial growth factor (VEGF), a potent mediator of angiogenesis and vascular     permeability, have been shown to be elevated in multiple cell types deficient in the VHL     protein (pVHL). Platelet-derived growth factor (PDGF), which has an important role in     stabilization of immature new vessels during angiogenesis, is upregulated in pVHL-defective     cell lines and expressed in other pVHL-defective tumors. Anti-VEGF therapy alone had no     beneficial effect on ocular VHL disease in two previous phase 1 studies. The objective of     this study is to investigate the safety and possible efficacy of combination investigational     treatment with serial intravitreal injections of E10030, a PDGF-B antagonist, and     ranibizumab, a VEGF-A antagonist, in participants with severe ocular VHL disease.      Study Population: Five participants with severe ocular VHL disease will receive the     combination investigational treatment in one eye and will be followed for 104 weeks. Up to an     additional two participants may be enrolled to replace participants withdrawing from the     study prior to their Week 52 visit.      Design: In this phase I/II, single-center, prospective, open label, non-randomized,     uncontrolled, single group trial, one eye of eligible participants will be treated with     investigational products, E10030, a PDGF-B antagonist, and ranibizumab, a VEGF-A antagonist.     Participants will receive combination investigational treatment consisting of intravitreal     injections of E10030 (1.5 mg in 0.05 mL) and ranibizumab (0.5 mg in 0.05 mL) every four weeks     from baseline through Week 16 (totaling five treatments) and then every eight weeks through     Week 48 (totaling nine treatments from baseline). Starting at Week 52, participants meeting     criteria for a sufficient response will be eligible to continue to receive injections as     needed as frequently as every 4 weeks through Week 92 in the treatment extension phase. All     participants will be followed for 104 weeks.      Outcome Measures: The primary outcome for the study will be safety of the combination     investigational treatment, assessed by tabulation of adverse events reported through Week 52.     Secondary outcomes will include tabulation of adverse events at Week 104, and the following     measures in the study eye at Week 52 and 104: the proportion of participants experiencing     reduction in size of at least one RCH in the absence of other ablative treatment (assessed by     fundus photography and fluorescein angiography [FA]); the proportion of participants     experiencing moderate vision loss (defined as a loss of greater than or equal to 15 letters     from baseline on Electronic Visual Acuity [EVA] testing); mean change in visual acuity;     change in size of RCH (measured by fundus photography and FA); change in exudation (measured     by fundus photography, optical coherence tomography [OCT] and FA); change in epiretinal     proliferation, fibrosis or retinal traction (assessed by OCT and fundus photography);     proportion of participants undergoing ablative treatment of RCH or ocular surgery; proportion     of participants with successful ablative treatment of RCH; and the proportion of participants     with appearance of one or more new RCH.   "
32571|NCT02859428|"     Background:      Hereditary spastic paraplegia (HSP) usually progresses slowly. Researchers want to learn more     about how its symptoms change over time. They want to look for changes in the blood and cells     of people with the most common forms of HSP that might allow them to better understand the     disease.      Objectives:      To learn more about common forms of hereditary spastic paraplegia and find out how it     progresses over time.      Eligibility:      People age 7 and older with SPG3A, SPG4A, or SPG31      Design:      Participants will have 1 two-hour visit each year for up to 5 years.      At 1 visit, adult participants may have a skin biopsy. An area of skin will be numbed then a     tool will remove a small piece of skin.      At all visits, all participants will have a physical exam and blood drawn.      At all visits, participants will do a few tasks like walking quickly and climbing stairs.      Participants can give permission for their skin cells, DNA samples, and data to be used in     other studies. The samples and data will have no identifying information.   "
32572|NCT02859415|"     Background:      Mithramycin is a new cancer drug. In another study, people with chest cancer took the drug 6     hours a day for 7 straight days. Many of them had liver damage as a side effect. It was     discovered that only people with certain genes got this side effect. Researchers want to test     mithramycin in people who do not have those certain genes.      <TAB>      Objectives:      To find the highest safe dose of mithramycin that can be given to people with chest cancer     who have certain genes over 24 hours instead of spread out over a longer period of time. To     see if mithramycin given as a 24-hour infusion shrinks tumors.      Eligibility:      People ages 18 and older who have chest cancer that is not shrinking with known therapies,     and whose genes will limit the chance of liver damage from mithramycin      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Lung and heart function tests      X-rays or scans of their tumor      Liver ultrasound      Tumor biopsy      Participants will be admitted to the hospital overnight. A small plastic tube (catheter) will     be inserted in the arm or chest. They will get mithramycin through the catheter over about 24     hours.      If they do not have bad side effects or their cancer does not worsen, they can repeat the     treatment every 14 days.      Participants will have multiple visits for each treatment cycle. These include repeats of     certain screening tests.      After stopping treatment, participants will have weekly visits until they recover from any     side effects.   "
32573|NCT02859402|"     Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role     of allogeneic stem cell transplantation have been demonstrated in these patients. This     clinical trial is studying the efficacy and safety of busulfan plus fludarabine as     conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and     NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies     including autologous transplantation.   "
32574|NCT02859389|"     Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits,     reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive     assessment is frequently implemented during therapy and continued into survivorship to     monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at     10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are     comparable to or lower than patients without DS, however, these patients are at greater risk     for treatment-related toxicities. Children with preexisting neurodevelopmental conditions,     including DS, are systematically excluded from neurocognitive assessment on clinical trials,     contributing to a gap in the investigators understanding of outcomes in these patients with     preexisting neurocognitive vulnerability. The investigators propose a novel preliminary     investigation of functional outcomes in children with DS and childhood leukemia. This study     has implications for future treatment of leukemia patients with DS, and may generalize to     leukemia patients with other predispositions or preexisting neurodevelopmental conditions     (e.g., genetic disorders, acquired brain injury, autism, and epilepsy).      Primary Objective:        -  To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia          with Down Syndrome using a novel assessment approach.   "
32575|NCT02859376|"     The objective of this trial is to compare the analgesic effect of a single dose of oral     sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular     puncture) versus multiple doses of oral sucrose 24% administered two minutes before and     during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks     hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant     Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual     Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).   "
32787|NCT02856594|"     This study aims to determine whether, compared with placebo, the nighttime administration of     a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative     delirium in extubated post-cardiac surgical patients.   "
32576|NCT02859363|"     Fabry disease is an X-linked disorder of glycosphingolipid catabolism caused by a deficiency     of the enzyme α-galactosidase A (α-Gal A), which leads to a progressive accumulation of     globotriaosylceramide (Gb-3) in plasma and tissue lysosomes throughout the body. Lysosomal     accumulation can result in lysosomal and cellular dysfunction, which leads to renal, cardiac,     and central nervous system (CNS) complications.      It is estimated that 1 in 40,000 males has Fabry disease, whereas the estimated prevalence in     the general population is 1 in 117,000 people. Newborn screenings for both classical and     atypical Fabry disease in Taiwan also revealed a markedly high incidence of 1 in 2,300 and 1     in 3,000 newborns. Cerebrovascular variant Fabry disease may affect up to 4.9% of male     patients and 2.4% of female patients with idiopathic stroke.      The diagnosis of Fabry disease can be challenging due to the diverse signs and symptoms,     different ages of onset, and variable timing and severity of progression. The importance of     Fabry disease lies in the irreversible renal, cardiac, cerebrovascular, and neurological     damage. An early diagnosis of Fabry disease is important for initiating symptom management     and reducing life-threatening complications, as well as for early identification of other     affected family members. Therefore, the present study would like to conduct further screening     of high-risk group of early cerebrovascular involvement that is essential for the successful     management of Fabry disease.   "
32577|NCT02859350|"     This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in     healthy Equatoguinean adults, adolescents, children and infants who receive doses of     0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via direct venous inoculation (DVI) compared     with control groups receiving normal saline (NS) placebo by DVI. In addition, the study will     also assess a second PfSPZ-based vaccination approach known as PfSPZ-CVac- the administration     of non-irradiated, infectious PfSPZ (PfSPZ Challenge) (1x10^5 PfSPZ) under anti-malarial     chemoprophylaxis (chloroquine) in younger adults ages 18 to 35 years for safety,     tolerability, immunogenicity and efficacy against controlled human malaria infection (CHMI).   "
32581|NCT02859298|"     Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of     premature delivery (TPD), the most important complication and the leading cause of     hospitalization during pregnancy has multiple origins which are seldom precisely identified.      The standard medical examination for the detection of patients with TPD is the endovaginal     ultrasonographic examination of uterine cervix (echography).      Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging     technologies with polarized light. The polarization is the spatio-temporal orientation of a     wave's electric field. This light property, invisible with the naked eye, is sensitive to the     morphological transformations of a tissue and the orientation of collagen fibers. Such tool     would not require an extensive training and should provide an objective quantitative result     with a sensitivity and specificity greater than conventional ultrasonography. This would be a     considerable contribution to the health care of TPD, a real societal problem in Belgium,     Europe and all over the world.      The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the     structural evolution, the density and the orientation changes of collagen fibers. A relevant     scoring of collagen status might provide an alternative, and potentially objective and     accurate quantifier of the time left before delivery.   "
32582|NCT02859285|"     The purpose of this research study is to learn about sexual function in postmenopausal women     and to determine whether the use of topical clitoral application of estradiol improves     women's libido, arousal, and orgasmic ability.   "
32583|NCT02859272|"     Female pelvic organ prolapse (POP) is characterized by lack of vaginal support which enables     pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital     hiatus. POP is more frequent among women who had their uterus removed.      We would like to investigate whether suspension of the top of the vagina during remowal of     the uterus prevents subsequent POP.      The purpose of the PhD project is therefore to describe validity, terminology, and operative     performance of used suspension methods during benign hysterectomy in Denmark. Further, to     investigate these suspension methods' possible association with pain, life quality,     sexuality, pessary use, and POP .   "
32584|NCT02859259|"     An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529     administered as BMS-663068   "
32585|NCT02859246|"     It is a pilot study aimed to determine if oral Mucinex® is effective in reducing the amount     of corneal filaments and improving symptomology in subjects with filamentary keratitis.   "
32586|NCT02859233|"     Postdural puncture headache (PDPH) is defined, according to the International Headache     Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15     minutes after sitting or standing and improves within 15 minutes after lying.      For preventing PDPH, there are some uncomfortable practices for patients (fluid     supplementation and bed rest) and expensive for hospital (time spend for information and     management of fluid intake). Patients are usually advised by nurses. If bed rest is not     effective in prevention of PDPH, fluid supplementation is not an advice based on any     evidence but only on routine. By this trial, the investigators want to evaluate the     scientific value of this advice, in the standard patient care.      The primary objective of this study is to compare oral hyperhydration (2 liters during 2     hours after lumbar puncture - the most common routine according to an internal pilot survey)     versus no advice about the fluid intake to prevent the PDPH.      The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.   "
32599|NCT02859064|"     Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can     be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide     (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA     approval to treat patients with metastatic NETs. The purpose of this study is to determine if     treatment for patients with NETs can be optimized by combining these therapies.   "
32600|NCT02859051|"     The purpose of this study is to determine if a preparation teaching intervention before IV     insertion, taught by MEDi to children and their parents, will lead to lower levels of     expected and experienced pain and fear and less distressing pain memories, as compared to     children who receive standard care. In addition, it will be examined whether this preparation     intervention will lead to greater parental self-efficacy, less anxiety, and less distressing     pain memories as compared to controls.   "
32601|NCT02859038|"     The purpose of this study is to answer the fundamental question, should the physicians choose     Surgery or Chemotherapy (SOC 2) in advanced ovarian cancer?   "
32587|NCT02859220|"     This study included 80 patients with end stage renal disease requiring dialysis treatment to     evaluate two techniques for the determination of parathyroid hormone (PTH)      Objective: To evaluate whether the monitoring of hemodialysis patients by measurement of PTH     1-84 Complete (CAP =cyclase activating PTH) and the ratio (1-84 PTH (CAP)/7-84 PTH (CIP =     cyclase inactivating PTH) with kit Duo PTH Immunoradiometric Scantibodies allows an     improvement in the therapeutic management of abnormal calcium and phosphate, with a better     match to the targets of current international recommendations, followed by the conventional     intact PTH assay.      Primary endpoint:      For each patient, a score will be awarded based on the number of criteria (including calcium,     phosphorus and calcium phosphate product) in the target international guidelines :0-1-2 or 3.      The primary endpoint will be the average scores in both groups at the beginning and the end     of the study,      Main secondary endpoints:        -  Changes in the number of patients responding to international guidelines for each of the          three parameters studied (serum phosphate, corrected calcium, phosphorus product) in the          2 groups,        -  Evolution of Elecsys intact PTH Roche in the 2 groups,        -  Salaries and changes in the number of drugs to normalize the phospho-calcium balance in          each group received,        -  cardiovascular events (morbidity and cardiovascular mortality),        -  Total mortality.      Statistical analysis:      This is a randomized, two parallel arms. The investigators will compare the average number of     criteria on calcium and phosphate in the target according to a Mann-Whitney. The analysis     will be performed with the software Splus.   "
32588|NCT02859207|"     The primary objective of the study is to evaluate the effects of hepatic impairment on the     pharmacokinetics (PK) of E2609 after a single dose administration.   "
32589|NCT02859194|"     ECMO(Extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure     patients. There are two types of ECMO, which is veno-veno (V-V) that can be used in     respiratory failure patients and veno-arterial (V-A) that can be used in cardiac failure     patients. V-A ECMO can also be used during lung transplantation, substitution of     cardiopulmonary bypass, which can show sufficient performance during operation and better     postoperative outcome. However, regarding V-A ECMO circulating from femoral vein to femoral     artery, there is a pro blem of differential hypoxia which might influence coronary artery and     head vessels. In this prospective study, the investigators are planning to put another ECMO     catheter into internal jugular vein which takes a role of left to right shunt, to mitigate     the hypoxia of coronary artery.   "
32785|NCT02856620|"     The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in     patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study)     Part I: Observational study to characterize phenotypes, structural alterations and biomarkers     profiles in a broad spectrum of patients with aortic stenosis and heart failure with     preserved ejection fraction (HFpEF).      Part II: Prospective cohort study to characterize patients' phenotypes, cardiac structural     alterations, circulating biomarkers and frailty in order to optimize risk stratification and     patient selection for aortic valve intervention.   "
32590|NCT02859181|"     Protein requirements in active individuals have been suggested to be greater than the current     recommended dietary allowance (RDA).      Nutritional requirements for dietary amino acids in adolescents have traditionally been     determined utilizing the nitrogen balance technique, which is prone to underestimating     protein requirements. As a result, there is a need to re-evaluate recommendations in order to     characterize how dietary amino acid needs may be modulated by physical activity.      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique     have suggested that protein requirements in young men are at least 50% higher than the RDA     based on nitrogen balance data.      The purpose of this study is to measure the protein requirement in adolescent, males using     the IAAO technique in the presence of a variable intensity exercise stimulus.   "
32591|NCT02859168|"     The purpose of this study was to show the immediate effects of myofascial induction on     perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer     survivors suffering shoulder/arm morbidity.   "
32592|NCT02859155|"     Determine clinical and pathological factors associated with perioperative morbidity and     mortality, and oncological outcomes after multivisceral en bloc resection in patients with     colorectal cancer.   "
32593|NCT02859142|"     The purpose of this study is to learn if the combination of a study drug and patch is more     effective in helping heavy drinkers stop smoking than just the patch alone The study drug,     varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop     smoking, but it is not known if the addition of varenicline to standard smoking cessation     treatment with nicotine patches will help people stop smoking who are regular, frequent     drinkers. This study is being done because cigarette smoking is the number one preventable     cause of death and disease in the United States.   "
32594|NCT02859129|"     This study is intended to evaluate the potential 2-way reciprocal interaction between     multiple doses of Epanova™ and a single dose of rosuvastatin   "
32595|NCT02859116|"     The purpose of this study is to help scientists understand how the gut senses ingested     nutrients and what kind of processes take place for their absorption in order to establish     the association with diabetes and other metabolic diseases Scientists need human specimens to     study.   "
32596|NCT02859103|"     Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major     depressive disorder (MDD), and it may impact how patients with depression experience reward.     Understanding how anhedonia is related to the experience of reward may help improve how     depression is treated. Computer tasks can be used to measure how reward is experienced, and     these measures might be able to predict things like who is likely to become depressed, or who     will respond to antidepressant medication. Studying the relationship between anhedonia and     reward in patients with depression might also tell us something about how to improve     diagnosis and treatment of other psychiatric disorders.This is an open label controlled     treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas     that may be related to how people perform on the tasks. The investigators goal is to use this     information to help us find a reliable predictor that can be used to guide MDD treatment.   "
33054|NCT02853110|"     The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal     SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with     acceptable toxicity in addition to whole gland prostate SBRT.   "
32602|NCT02859025|"     Our aim was to combine regenerative techniques with bone grafting in human models to increase     predictability and survival of reconstructed tissue. The MSCs in this study were derived from     an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules     and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar     cleft defects.   "
32603|NCT02859012|"     To understand efficacy of axitinib in recurred or metastatic adenoid cystic carcinoma   "
32827|NCT02856139|"     PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using     ultra-widefield fluorescein angiography (UWFA).      DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with     best corrected visual acuity ≥ 20/20, refractive error < 3.00D, and without visible retinal     pathologic changes under a slit lamp-based condensing lens. The far peripheral retina was     detected by UWFA. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to     the scleral spur was measured by ultrasound biomicroscopy.   "
32604|NCT02858999|"     Plasma cell leukaemia is a rare variety of multiple myeloma with a poor prognosis. Plasma     cell leukaemia is defined as: at least 2,000 circulating plasma cells per µL for a blood     leukocyte count higher than 10,000/µL or 20% of plasma cells for a leukocyte count less than     10,000/µL. Plasma cell leukaemia can be either primary, when it constitutes the first     manifestation of the disease, or secondary in the setting of relapsed/refractory multiple     myeloma. Primary plasma cell leukaemia (PPL) is a rare disease, representing only 1 to 2% of     all cases of multiple myelomas at diagnosis. As the annual incidence of multiple myeloma in     France is about 4,000 new cases, an estimated 40 to 80 new cases of PPL would be observed     each year.      Few data are currently available in the literature concerning the pathophysiology and     therapeutic management of PPL, and are derived from retrospective series based small numbers     of patients. The prognosis of PPL in response to conventional chemotherapy remains poor with     a median survival of 7 to 14 months. However, longer survivals have been obtained with     intensive therapy and haematopoietic stem cell transplantation (allogeneic or autologous     HSCT).      The investigators propose to perform a prospective study of the management of patients with     PPL under the age of 70 years, in combination with a laboratory study: 12 weeks of induction     chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with     Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles. Peripheral blood     stem cell collection after mobilization by G-CSF will be performed after high-dose     Cyclophosphamide chemotherapy. Autologous HSCT conditioned by high-dose Melphalan will be     performed during the following month for all responding patients. During the 3 months after     this first autologous HSCT, allogeneic HSCT with attenuated conditioning will be proposed in     patients under the age of 66 years in complete remission with a suitable donor, and another     systematic autologous HSCT will be proposed in all other patients. For all patients not     treated by allogeneic HSCT, consolidation/maintenance therapy will be performed 3 months     after the second autologous HSCT: 4 quarterly consolidations with     Bortezomib-Lenalidomide-Dexamethasone (VRD) with maintenance by 2 months of Lenalidomide     between these cycles, for a total duration of one year.      The laboratory assessment will consist of blood and bone marrow samples systematically     obtained at diagnosis for plasma cell phenotyping by cytometry, cytogenetics, FISH, study of     the gene expression profile and SNParray. A DNA bank and plasma bank will be constituted. The     investigators also propose to study residual disease by cytometry (after the first autologous     HSCT, before and at the end of the consolidation/maintenance phase), as it increasingly     appears to have a major impact on survival in multiple myeloma.   "
32605|NCT02858986|"     Introduction: Three-dimensional key-hole surgery ('laparoscopic') systems are proven to     reduce the time required to complete tasks in laboratory settings. This benefit derives from     the addition of binocular depth perception cues when compared to two-dimensional (2D)     systems. This year a '4K' laparoscopic system has become commercially available, so-named as     it provides a high resolution 2D image with four times the number of pixels of 2D full high     definition. The improved visualisation is likely to provide additional non-binocular depth     cues. It is currently unclear to what degree improving the resolution of 2D systems can     compensate for binocular depth cues.      Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides     benefits in simulated tasks when compared to the monocular vision provided by high-resolution     4K systems.      Methods: Two experiments will be performed: 1) A laboratory assessment of 3D versus 4K     laparoscopic systems against industry optical standards, 2) A study to assess the benefits to     novices and expert surgeons of using 3D and 4K laparoscopic systems during laparoscopic     simulator tasks. The primary outcome measure is number of errors during laparoscopic     simulator tasks. The secondary outcome measures include: objective and subjective measures of     picture quality, task completion time, side effects (such as eye discomfort) and cognitive     workload during laparoscopic simulator tasks      Impact: This study is a unique, first-of-its-kind investigation into two new surgical     technologies, and is the first study to involve a 4K system. The uptake of three-dimensional     systems has been curbed by financial cost and the limitations of early 3D technologies. This     study aims to determine which system may be the safest, quickest and most cost- effective, in     order to guide future investment and technological development towards either 3D or 2D     systems. In addition, these systems may also aid in the learning curve of trainee surgeons.   "
32606|NCT02858973|"     This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203     in healthy volunteers conducted at one study center in the United States   "
32607|NCT02858960|"     The aim of this study is to compare exercise capacity in COPD patients through two different     systems of supplemental oxygen delivery: High Flow Nasal Cannula Oxygen (HFNCO) and The     Venturi Mask (VM).   "
32608|NCT02858947|"     The aim of this study was to investigate the clinical effectiveness of direct resin composite     restorations placed with different placement techniques (incremental or bulk) and with     different flowable linings (conventional or bulk-fill flowable) used in open-sandwich     technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in     a randomized controlled comparison.   "
32609|NCT02858934|"     The standard treatment for women with a relatively small breast cancer without arguments for     involvement of the axillary lymph nodes, is breast conserving surgery followed by     radiotherapy of the whole breast, often with a complementary dose to the operated area     (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before     the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered     in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in quality     of life. Randomized trials have shown that shorter schedules, delivering slightly more dose     per day during 3 weeks, are equal to the long schedules. In an earlier clinical study, the     investigators have tested such a short schedule and shown that it is equally safe and equally     well tolerated as the conventional schemes. Other hospitals have examined (and still are     examining) the safety and tolerance of even shorter schedules, delivering radiotherapy in 1     week.      This clinical study involves delivering radiotherapy in 1 week and before the surgery in     stead of following surgery. In the postoperative setting, it is often debatable which volume     should be included in the boost. Often boost-volumes remain large because of uncertainties in     delineation. Preoperative radiotherapy has the advantage that the tumor is visible on     imaging. This can result in smaller boost volumes. The surgery will follow shortly after     termination of the radiotherapy, resulting in a very short treatment period.      This study is an open study investigating the effect on quality of life of a very short     preoperative radiotherapy for early breast cancer.   "
32610|NCT02858921|"     This study aims to determine which of 3 drug combinations best reduces the size of tumour     prior to surgery for advanced melanoma and prevents the recurrence of melanoma after surgery.   "
32611|NCT02858908|"     The purpose of this study is to determine whether Tideglusib is safe and efficacious in the     treatment of adolescents and adults with congenital and juvenile-onset Myotonic Dystrophy.     The pharmacokinetics of tideglusib and its primary metabolite will also be investigated.   "
32612|NCT02858895|"     This is a single-arm, open-label, multicenter study in approximately 43 adults with primary     (de novo) GB that has recurred or progressed (first or second recurrence, including this     recurrence) after treatment(s) including surgery and radiotherapy with or without     chemotherapy and following discontinuation of any previous standard or investigational lines     of therapy. Eligible subjects will receive intratumoral infusion of MDNA55 administered via     convection-enhanced delivery (CED).   "
32613|NCT02858882|"     People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due     to low sun exposure and the risk may be even more pronounced among elite swimmers since     indoor training further reduces sun exposure. In light of this, the investigators want to     examine vitamin D status in young elite swimmers and if there is an association between     vitamin D status and muscle strength.   "
32614|NCT02858869|"     This pilot trial studies the side effects of giving pembrolizumab together with stereotactic     radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to     the brain. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of     tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy     that delivers a single, high dose of radiation directly to the tumor and may cause less     damage to normal tissue. Giving pembrolizumab together with stereotactic radiosurgery may be     a better treatment for patients with melanoma or non-small cell lung cancer that has spread     to the brain.   "
32615|NCT02858856|"     This is a pilot study that investigate efficacy and safety of Deciten granule on immunity of     patients with breast carcinoma receiving chemotherapy.   "
32616|NCT02858843|"     The purpose of this research study is to find out if the combined therapy     lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.   "
32617|NCT02858830|"     Studying patients with rare adipose tissue disorders may help the investigators to better     understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and     thus have an enormous impact on public health.   "
32618|NCT02858817|"     Single center, randomized, placebo-controlled, double-blinded trial using PfSPZ Challenge     (NF54) under A/P chemoprophylaxis for immunization and PfSPZ Challenge (NF54) for repeat     CHMI.      A total of 30 adult, healthy, malaria naïve volunteers will receive three injections by     Direct Venous Inoculation (DVI) of either placebo (n = 10), 51,200 PfSPZ Challenge (NF54) (n     = 10), or 150,000 PfSPZ Challenge (NF54) (n = 10) under chemoprophylaxis with A/P at 4 week     intervals. The placebo will be NaCl 0.9%.      Ten weeks after the last dose of PfSPZ Challenge (NF54) for immunization, volunteers will     undergo first CHMI and followed until asexual blood stage parasitemia, detected by     quantitative real time PCR (qPCR) or thick blood smear microscopy. If parasitemic, they will     be treated with A/P (used in this case as a standard treatment regimen). In the event of no     parasitemia, volunteers will be followed until Day 28 post-CHMI and will not receive A/P.      Forty-four weeks after the last immunization, a second CHMI will be administered to assess     longevity of protection. All volunteers will be followed up to 28 days post-inoculation.     Those developing parasitemia will be treated with A/P.   "
32619|NCT02858804|"     The purpose of this study is to:        1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide          and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen          combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);        2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance          regimens.   "
32620|NCT02858791|"     The investigators will investigate the interrelationship of macrophage migration inhibitory     factor (MIF) and free T4 in patients with PAH.   "
32621|NCT02858778|"     A prospective randomized controlled trial studying the ordering of palliative care     consultations in the emergency department (Ig) versus later palliative care consultations in     the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with     a 1:1 ratio.   "
32622|NCT02858765|"     The purpose of this project is to study the influence of light on sleep, wakefulness, EEG     activity and cognitive performances. The study aim also to evaluate techniques for     registration and analysis of the EEG over periods of time.   "
32623|NCT02858752|"     This project studies memory and attention in healthy children aged from 5 to 17 years. The     processes investigated are short term memory (auditory and visual) and attention.      To characterize these processes involved in childhood, neuropsychological and     neurophysiological assessments will be performed (using Electro-encephalography measures,     behavioural responses and questionnaires).   "
32624|NCT02858739|"     AIM OF THE STUDY: The aim of the present registry is to investigate the procedural as well as     the long-term clinical results in terms of safety and efficacy of the polymer-free DES     technology in all comers patients with an indication to percutaneous coronary intervention.      PRIMARY SAFETY ENDPOINTS: the cumulative hierarchical incidence of major adverse cardiac     events (MACCE) defined as: cardiac death, non-fatal myocardial infarction (MI), stroke and     ARC-defined stent thrombosis (18) at any time point and bleeding defined according to BARC     classification (19).      PRIMARY EFFICACY ENDPOINTS: clinically driven target lesion revascularization (TLR).      STUDY DESIGN: multicenter (presumably 10 centers across the Italian territory), prospective     observational registry aiming to enroll a population of 1000 patients.      STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last     patient in the registry.      CLINICAL FOLLOW-UP PLAN: 30 days, 3, 6, 9 months, 1 year, and then yearly up to 5 years after     the index procedure.      PATIENTS SELECTION CRITERIA:      This is an all comers registry and patient who will be enrolled have to meet the sequent     criteria:        -  Patient must be at least 18 years of age at the time of signing the Informed Consent          Form after Biofreedom placement.        -  All de novo lesion subsets are included.        -  Patient must agree to undergo all required follow-up visits and data collection.        -  Patient must have indication to percutaneous coronary intervention following:             -  Stable angina or evidence of myocardial ischemia with stress echocardiography/               myocardial SPECT/exercise test, or             -  Unstable angina / non ST-elevation myocardial infarction             -  ST-elevation myocardial infarction with de novo culprit lesion.      EXCLUSION CRITERIA:      The exclusion criteria must follow the most recent IFU which may include but are not limited     to the following:        -  Known intolerance to any of the device components        -  In-stent restenosis        -  Woman with childbearing potential        -  Age < 18y/o        -  Inability to provide written informed consent      EFFICACY PARAMETERS: TLR and TVR up to 5-year follow-up.      SAFETY PATIENT ORIENTED PARAMETERS: all cause mortality, any myocardial infarction, Stent     thrombosis based on the ARC classification, up to 5-year follow-up and bleeding occurrence     according to BARC classification. Data on dual antiplatelet therapy use will also be     collected and analyzed according to duration and cessation modalities.      Sample size justification: Being this an observational registry aiming at quantifying effect     estimates without direct comparisons to other devices for coronary angioplasty, we relied on     confidence interval profiling for sample size justification, without proceeding with formal     power analysis. The main analysis will be an overall and comprehensive analysis and it will     be planned the primary analytical approach of all-comers patients with coronary artery     disease and indication to PCI. Accordingly, we computed that a target sample of 1000 patients     will enable the computation of reasonably precise 95% confidence intervals. Specifically,     assuming a 8% MACE rate at 1 year (in keeping with RUDY study and LEADERS FREE trial design),     confidence intervals computed with the adjusted Wald method would be 7.1% to 9.6% for a     1000-patient sample (point estimate 80/1000 [8.0%]). Given that the registry aims to reflect     real-world patients and practice, no prevision to limit or restrict patient enrollment is     considered.      Analytical plan: Continuous endpoints will be summarized by presenting the total number of     patients, mean, standard deviation, median, minimum, and maximum. Tabulation of categorical     parameters will include counts and percentages. The outcomes will be summarized as both a     discrete and a continuous variable using the method described above. Survival analysis will     be performed with the Kaplan-Meier method. Statistical inference will be based on the     computation of 95% confidence intervals using the adjusted Wald method. Additional analyses     will involve key subgroups defined according to baseline, lesion, and procedural features,     with statistical significance set at the 5% 2-tailed level. Specifically, Student t, Fisher     exact, and log-rank tests will be used for such bivariate analyses, whereas multivariable     linear regression, logistic regression, and Cox proportional hazard analyses will be used to     adjust for confounders.   "
32625|NCT02858726|"     2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in     patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients     will receive either CR845 or placebo after each dialysis session for eight weeks. The safety     and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will     also have pharmacokinetic assessments completed. Part B of the study will assess one dose of     IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe     itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part     A.   "
32627|NCT02858700|"     After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP),     the pediatrician must make a difficult decision quickly or not to prescribe additional     examinations and / or hospitalize or not the newborn in order to administer parenteral     antibiotics. This decision takes into account several contextual data, (clinical, biological     and bacteriological clinical data) to be considered simultaneously. These information lack     sensitivity and specificity.      Therefore, the common attitude among newborns in many countries remains the achievement of a     significant number of additional tests and the establishment, without a prior evidence of     infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization.     However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:        1. one source to higher health care costs (hospitalization, additional examinations)        2. Selection of the bacterial ecology of the newborn and neonatal services and        3. stress for the newborn and parents   "
32828|NCT02856126|"     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion     chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with     hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).   "
32628|NCT02858687|"     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the     diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the     reception of Emergency service. In this instance 30% of patients have no etiological     diagnosis after the POC tonsillitis tests . This lab has discovered over 200 new species of     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy     of tonsillitis after POC tests.      The objective of this study is to implement a new diagnosis strategy relying on the     hypothesis that a second pharyngeal swab would improve the etiological diagnosis of     tonsillitis of at least 5%.   "
32629|NCT02858674|"     The objective of this proposal is to develop, implement, and test the effectiveness of a     computerized clinical decision support system for hospitalized patients with heart failure.      Aim 1: Develop an electronic health record (EHR) based search method that uses both     structured data and natural language processing of unstructured text to identify hospitalized     patients with heart failure while they are still in the hospital.      Aim 2: Develop and test the usability of an electronic health record (EHR) based clinical     decision support system (CDSS) to support delivery of evidence-based care to hospitalized     heart failure patients using human computer interaction methods.      Aim 3: Assess the effect of an electronic health record (EHR) based clinical decision support     system (CDSS) on processes of care for heart failure patients who are hospitalized for other     causes. As part of the evaluation, we will test two implementation strategies, one of which     will introduce the CDSS as an interruptive alert to providers, the second of which will     introduce the CDSS as part of a provider checklist that exists on the side of the screen for     each patient.   "
32630|NCT02858661|"     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the     diagnosis in less than two hours of meningitis caused by known pathogens, close to the     reception of Emergency service. In this instance 30% of patients have no etiological     diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy     of meningitis after POC test.   "
32631|NCT02858648|"     The purpose of this study is to examine whether a behavioral lifestyle intervention using     mobile smart phone technology for self-monitoring can lead to greater improvements in     diabetes outcomes.   "
32632|NCT02858635|"     Suicide is a major health problem that causes annually a million death worldwide. In the     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an     individual's predisposition and stressful condition. According to this model, individuals who     carry a suicidal act when subjected to stress factors (environmental stress, depression,     substance ...) are those which have a specific vulnerability.These vulnerabilities can be     considered as clinical parameters (propensity to despair, aggressive and/or impulsive     traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and     cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly     underpinned by genetic factors. The interest of current researches is to identify biomarkers     that will improve the opportunities for early identification of subject with a risk for SB.      The four goals of this project are in the continuity of previous works team:        1. To determine whether combinations of the main serotonin-related genes may better          contribute to the vulnerability to SB, than when they are considered independently.        2. To assess whether the associations between these genes and SB are modulated by childhood          trauma, life events and stress response associated with these environmental factors.        3. To test the value of combined clinical, neuropsychological and genetic factor for          suicide prevention, in a prospective study, in particularity impulsivity and gene gene          interaction.        4. To investigate the association between events in real life (using ecological momentary          assessment) and emotional response and suicidal ideation.      The investigators propose to use a multidisciplinary approach to answer these questions and,     hence, be able to identify new prevention strategies for SB.   "
32633|NCT02858622|"     Alleviating pain in children undergoing renal transplant is extremely challenging. Large     incisions as those of renal transplant (Gibson's incision) require special techniques of pain     control that don't affect hemodynamics or renal function. Since the transplant incision     doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control     in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior     abdominal wall together with the underlying parietal peritoneum.   "
32634|NCT02858609|"     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the     diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the     reception of Emergency service. In this instance 30% of patients have no etiological     diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy     of diarrhoea after POC tests.   "
32643|NCT02858492|"     This study is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase     inhibitor, in subjects with moderate to severe RA who are currently being treated with     disease modifying anti-rheumatic drugs (DMARDs). The primary objective of the study is to     investigate the safety and tolerability of repeat oral doses of GSK2982772 in subjects with     moderate to severe RA. In addition to the PK, a number of experimental and clinical endpoints     will be employed to obtain information on the PD, and preliminary efficacy in subjects with     active RA. Although no formal hypothesis will be tested, these endpoints will enable a     broader understanding of the mechanism of action and potential for clinical efficacy of     GSK2982772 in RA. After a screening period of up to 30 days, approximately 30 subjects will     be randomized to receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a     follow-up period (28 days). The total duration of participation in the study will be     approximately 20 weeks from screening to the last study visit.   "
32635|NCT02858596|"     Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure for long-term     enteral tube feeding in patients with insufficient oral intake. Although peristomal site     infection is often noted as the most common adverse event after PEG tube placements, it is     seldom life-threatening and considered a minor adverse event. Feeding-related adverse events     have been identified as the main cause of death after PEG, with up to 50% of postoperative     early mortality (30 days) being attributed to aspiration pneumonia. This may be related to     the persistence of gastroesophageal reflux (GER) of enteral feed after gastrostomy, even     though PEG have been demonstrated to be superior to nasogastric tube feeding in terms of     preventing GER. It has been more than a decade since semi-solid feeds were developed as an     alternative to conventional liquid feeds to prevent feeding-related adverse events.     Unfortunately, there is limited published literature on this topic despite the wide usage of     this feeding method in Japan. Amidst the growing popularity of this method and the     introduction of National Healthcare Insurance coverage for semi-solid feed prescriptions, we     initiated a semi-solid feed protocol along with our existing post-PEG feeding protocols in     2014.   "
32636|NCT02858583|"     Research question In newborn infants requiring CPR, does CC superimposed by sustained     inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous     circulation?      Overall objective: CC superimposed by sustained inflation will improve short- and long-term     outcomes in preterm and term newborns.      Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation     (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC)     compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated     newborns.   "
32637|NCT02858570|"     TYPE / DESIGN STUDY: Clinical trial phase II / III, randomized, double-blind, national     multi-center, with a total of 1,644 research participants stratified into 3 groups according     to age for starting of the primary vaccination schedule (Stratum I - 11 to 19 years, Stratum     II - 1 to 10 years; Stratum III - less than 1 year old).      BACKGROUND / STUDY CASE: Clinical trial phase II / III, which purpose is to evaluate     immunogenicity, safety and reactogenicity of the vaccine against meningococcus C, conjugated     to tetanus toxoid, developed by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). The hypothesis of the     study is that MenCC-BIO vaccine is safe and not inferior in terms of immunogenicity to the     comparator vaccine currently available for the National Immunization Program in the child's     immunization schedule. Thus, MenCC-Bio vaccine may meet the need for expansion of the target     age group of vaccination in routine public health services and will be available to the     National Immunization Program as a strategy to ensure sustainability and self-sufficiency to     vaccination policy.      OBJECTIVES PRIMARY: To assess the immunogenicity of MenCC Bio-vaccine in patients from 3     months to 19 years of age, in relation to the vaccine against meningococcus C currently     provided by the National Immunization Program. To evaluate the safety and reactogenicity of     MenCC Bio-vaccine in patients from 3 months to 19 years old.      SECONDARY OBJECTIVES: Evaluate the cellular immune component to meningococcal C conjugate     vaccine in a subset of survey participants, aged 11 to 19 years.      STUDY POPULATION: Individuals of both sexes, healthy, aged between 3 months and 19 years,     attending the campus of Fiocruz / Rio de Janeiro, or municipal health units in Rio de Janeiro     (living in areas covered by the municipal units health participants) that fit in the study     eligibility criteria.      NUMBER OF CENTRES: Two Clinical sites.      STUDY DURATION: Estimate of 19 months.      INTERVENTION / TREATMENT: Two intervention groups (MenCC-BIO Vaccine and Comparator) in three     age groups, with specific vaccination schedules. For the age groups I and II are applied 2     doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the     vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National     Immunization Program.      OUTCOMES PRIMARY:      Immunogenicity:      Proportion of seroconversion defined by the seronegative status change (titles of     bactericidal antibodies in children rabbit complement than 1: 8) to seropositive (titers of     bactericidal antibodies in larger rabbit complement or equal to 1: 8) or increase 4 times of     post vaccinal compared to pre-vacianais after the full vaccination schedule by age stratum.      Geometric mean antibody titers (TGM) pre- and post-vaccination, for each vaccine group, and     the ratio of these securities after the full vaccination schedule by age stratum.      Safety and reactogenicity: Frequency and intensity of adverse events solicited and     unsolicited, which occurred 30 days after vaccination.      SECONDARY OUTCOME : cell detection B (CD19 +) memory phenotype (CD27 + IgD +, CD27 + IgD) in     a subgroup of patients in the age stratum I (11-19 years old). ADDITIONAL INFORMATION age     escalation, with interim analysis of inter-layer security and approval by the Security     Independent Monitoring Committee of progression to the next lower age stratum.   "
32638|NCT02858557|"     This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean     diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in     patients after pouch surgery and to assess the effect of a personal tailored diet, based on     microbial profile, on disease outcomes and generate a predictive model for future     interventions.   "
32639|NCT02858544|"     The primary goal of this study is to provide clinicians with a brief, patient self-administer     instrument yielding a single composite score that reliably correlates with objective findings     on standardized neurocognitive assessment for concussion.   "
32640|NCT02858531|"     Epidemics and infectious diseases in general, punctuate much of the activity of an emergency     service. The impact of winter infections is particularly important to vulnerable populations     such as infant during bronchiolitis epidemics and the elderly during seasonal influenza. Each     year, these epidemic phenomena lead to disorganization of emergency services and healthcare     teams by lack of anticipation and organizational measures in particular to manage the     approval of emergency services for the most vulnerable populations requiring hospitalization.      For 2 years, the pediatric emergency department of St Etienne University Hospital has a     decision support tool for the periods of winter epidemics. Through a retrospective analysis     of Passages of Emergency summary, this tool provides an estimate of infants with     bronchiolitis flow day to day, and the availability in real time of an abnormally high flow     of patients to pediatric emergencies. These data can help to affirm that the epidemic begins     in this hospital.   "
32641|NCT02858518|"     Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood     flow. It is a public health problem with 600,000 to 1 million people involved in France which     2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of     embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant     standard treatment helps prevent the occurrence of this complication.      However, oral anticoagulation also exposes patients to an increased risk of bleeding. The     bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED,     ATRIA and scores Shireman and Charlson ...).      moreover, in geriatric hospital care, every patient has a standardized geriatric assessment     to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional     status, psychological state and its environment social.      Thus, the objective of the investigators study was to determine the frequency of each item of     each bleeding risk assessment score and geriatric assessment in patients 80 and older     hospitalized geriatric ward in the department and with anticoagulant.   "
32642|NCT02858505|"     Anaemia is the most worldwide health problem affecting pregnant women in both developed and     developing countries. During pregnancy there is an inconsistent increase in plasma volume and     haemoglobin mass.      Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman     needs about 1000 mg of iron during pregnancy.      Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day)     so the Centers for Disease Control and Prevention recommend that pregnant women take a daily     supplement of 30 mg of elemental iron as a preventive dose. As most women begin their     pregnancy with low iron stores, particularly in the second and third trimesters, so     prevention should start as soon as possible even before pregnancy to prevent depletion of     iron store and further Iron deficiency anemia.      Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia     during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous     sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with     constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and     vomiting.      Iron amino acid chelates have been emerged to be used as agents for prevention and treatment     of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy     with minimal unpleasant side effects.      Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low     birth weight and preterm birth. The iron requirement for twin pregnancy is probable double     fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually     lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.   "
32671|NCT02858128|"     The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted     magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with     those from choline-positron emission tomography-computed tomography (choline-PET/CT) in     patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile     who could benefit from treatment with stereotactic body radiation therapy (SBRT) were     selected and their responses to these techniques were rated.   "
32644|NCT02858479|"     Neuropathic pain is a medical condition involving allodynia (painful perceptions in response     to stimuli that normally are not) and spontaneous pain (occurring at rest, without     stimulation).      This pain is secondary to nervous system injury affecting the sensory system. The lesion is     either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity and     reorganization of brain activity.      Previous studies in functional neuroimaging have focused on brain areas activated during     allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but     it was not possible to conclude formally.      The objective of this study is to understand the brain dysfunction that induces allodynic     pain considering the deafferentation of each patient and possible cortical losses.   "
32645|NCT02858466|"     Neuropathic pain is a medical condition involving allodynia (painful perceptions in response     to stimuli that normally are not) and spontaneous pain (occurring at rest, without     stimulation).      This pain is secondary to nervous system injury affecting the sensory system. The lesion is     either at the nerve endings of the spinal cord or brain.      It induces a loss of sensitivity and likely reorganization of brain activity that are causing     pain and which are the subject of this study.      Previous studies in functional neuroimaging has focused on brain areas activated during     allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but     it was not possible to conclude formally. The authors failed to assess the part of the effect     of the loss of sensory afferents (deafferentation) and the basal brain function.      Indeed, the operation without any sensory stimulation is not known yet is the initial level     of activity which is the benchmark for studying brain function during stimulation. The     objective of this study is to understand what are the cortical systems of allodynic     dysfunctional in patients compared with controls at baseline.   "
32646|NCT02858453|"     This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other     urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants     will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the     study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52     weeks.   "
32647|NCT02858440|"     The purpose of this study is to evaluate the immune response, safety and reactogenicity after     receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination     course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian     healthy children according to the Russian immunisation schedule   "
32648|NCT02858427|"     The study aims to determine the correlation between the cognitive inhibition impairment and     the history of suicide attempt in elderly depressed patients.   "
32649|NCT02858414|"     This study evaluates the impact of highly active antiretroviral therapy on the size of the     latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The     activation state of the cells will be assessed, by measuring the activation of Akt, to     determine its influence on the size of the viral reservoirs.   "
32650|NCT02858401|"     The primary objectives of this study are to evaluate the safety and tolerability of a 6-dose     regimen of vesatolimod (formerly GS-9620) (at 1 mg, 2 mg, and 4 mg dose levels) in HIV-1     infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the     virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.   "
32651|NCT02858388|"     The goal of the study is to investigate if the active agent of Sinuclean Nebules is     efficacious in the treatment of pediatric exudative otitis media, comparing with saline.      Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg,     extracted from Ecballium Elaterium.   "
32652|NCT02858375|"     The study aims to assess and compare the pain in women suffering from provoked     vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18     months after treatment.   "
32653|NCT02858362|"     A Phase 2 Clinical Study to Assess the Activity and Safety of Utrophin Modulation with SMT     C1100 (ezutromid) in Ambulatory Paediatric Male Subjects with Duchenne Muscular Dystrophy     (DMD)   "
32654|NCT02858349|"     Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week     control period and a 4-week exercise intervention.   "
32655|NCT02858336|"     Background:      Functional hypothalamic amenorrhea (functional HA) is a condition where a woman s period     stops for a temporary time. This is due to improper function of the hypothalamus. This is the     part of the brain that directs the whole reproductive system. Researchers want to learn more     about functional HA. They also want to learn how diet, exercise, and other factors may change     women s menstrual cycles.      Objective:      To better understand functional HA.      Eligibility:      Healthy women ages 18 28 years old who:      Have regular periods      Exercise no more than 4 hours a week      Had their first period at age 11 14      Design:      Participants will be prescreened over the phone.      Participants will be screened with:      Blood and urine tests      Medical history      Physical exam.      Participants will have 9 or 10 visits over about 3 menstrual cycles. These include:      Repeat of screening tests      Questionnaires      Exercise test      Resting energy expenditure test: Participants fast overnight before the test. They lie on     their back under a      canopy for a half hour.      Body composition test: This is done with a dual energy x-ray absorptiometry (DXA) scan.      Pelvic ultrasound      For two full-day visits, an IV is inserted into an arm vein. The IV takes a blood sample     every 10 minutes for 8 hours.      Participants will keep logs:      Menstrual cycle log      Diet log for three 4-day cycles      Participants will receive test kits to complete at home:      Daily blood and urine sample      Ovulation      Participants will take a daily iron supplement. They will wear a wristband that monitors     activity 24 hours a day.      Participants will stick to a special diet for two 5-day periods of time. They will complete     two 4-day exercise programs.   "
32691|NCT02857855|"     The aim of this prospective randomized controlled trial is to evaluate the impact of high     concentration supplemental postoperative oxygen therapy on short-term and long-term results     of liver transplantation, particularly with respect to infections and biliary complications.   "
32692|NCT02857842|"     This study explores whether patients hospitalized with chronic obstructive pulmonary disease     (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect     by controlling the treatment by daily measurements of eosinophils.   "
32656|NCT02858323|"     Background:      Platelets are blood cells that help blood clot. Some people have what is called     thrombocytopenia. This means they have a low blood platelet count. They need platelet     transfusions very often. Human leukocyte antigen (HLA) alloimmunization occurs for a lot of     these people. They become refractory. This means their platelet levels no longer increase     after transfusions. Researchers want to study a procedure that detects HLA antibodies. They     want to test how well it predicts how a person will respond to a transfusion. They want to     see if it does this better than the procedure that is usually used.      Objective:      To study the effect of C1q-binding of Class I HLA antibodies on platelet refractoriness in     people who get platelet transfusions. To test if this method better predicts response to     platelet transfusion than the IgG solid phase immunoassay method.      Eligibility:      People enrolled on protocols 11-C-0136, 08-H-0156, 03-C-0277, 01-C-0157, or 01-C-0129 who:      Agreed to have their specimens and data used for future research      Had Class I HLA antibodies detected by the IgG method      Had one or more platelet transfusions at NIH after the first positive HLA IgG antibody result      Design:      For each participant, researchers will look at a small portion of their archived plasma     sample. The samples were left over from prior HLA antibody tests.      Participants samples will be analyzed. They will be tested to see if C1q-binding HLA     antibodies are present. This will be done by solid phase immunoassay. Results will be     compared with the past results of the IgG method.      Participants data will be stored in database that s protected by password.   "
32658|NCT02858297|"     Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of     chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect and     was administrated orally in osteoarthritis and atopic dermatitis therapy. Given the Oral     lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising     therapeutic option. The investigators compared clinical effectiveness of Glucosamine combined     with two topical corticosteroid regimens to that of topical corticosteroid alone in     symptomatic OLP and investigated therapeutic mechanism by examining treatment effect on     expression of inhibitor kappa kinase alpha (IKKα) and interleukin-8 (IL-8) in OLP lesions.   "
32659|NCT02858284|"     The purpose of this study is to evaluate whether the TUG device is safe and effective in     patients with primary open angle glaucoma or ocular hypertension.   "
32660|NCT02858271|"     Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and     pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers   "
32661|NCT02858258|"     The primary objective of the the trial is to establish one of three study arms, as future     standard based on the comparison of the investigator-assessed failure-free survival.   "
32662|NCT02858245|"     A prospective, open-label, and multi-centered feasibility registry.   "
32663|NCT02858232|"     Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that     dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded     with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell     proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly     re-infused. The previous research data showed that MASCT had the modest overall response and     less adverse effects for Hepatocellular Carcinoma patients.      The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.   "
32664|NCT02858219|"     The main objective of this study is to compare the efficacy of botulinum toxin injections on     vestibulodynia pain compared to a group treated with a placebo.   "
32665|NCT02858206|"     This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent     nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and     pathological lymph node metastases rate in premise of lower toxicities in locally advanced     esophageal cancer.   "
32666|NCT02858193|"     To investigate the bioequivalence between two formulations containing     S-carboxymethyl-L-cysteine L-lysine monohydrate salt (SCMC-lys) when administered as single     oral dose in two consecutive study periods to healthy male and female volunteers under     fasting conditions.   "
32667|NCT02858180|"     This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have     advanced cardiac disease or advanced lung disease.   "
32668|NCT02858167|"     The purpose of this study is to define a reference population for FDG-PET neurological     examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma     (tumor in remission, low disabling chronic tumor).   "
32669|NCT02858154|"     This is a small pilot study that will compare High Flow Nasal Cannula (HFNC) therapy to     oxygen nasal cannula therapy on infants who have obstructive sleep apnea (OSA) and are     scheduled for a clinically ordered sleep study called polysomnography (PSG). The HFNC     procedure uses humidified room air delivered by nasal cannula at higher pressures and will     test if HFNC can control OSA in infants better or as well as low flow nasal oxygen, the     current clinical standard of care. All the infants in the study will have a brief test period     of about 3 to 4 hours with the HFNC before participants begin their standard clinical PSG for     titration of oxygen by nasal cannula for treatment of OSA.   "
32670|NCT02858141|"     This data base has been set in order to gather oncogeriatric information from elderly     patients with pancreatic cancer who underwent an oncogeriatric evaluation.      ONCOGEPAN database gathers data from deux institutions (Institut Paoli-Calmettes and     Assistance Publique des Hôpitaux de Marseille) involved in Marseille SIRIC (Integrated Cancer     Research Site).   "
32672|NCT02858115|"     During thoracic surgery, an excessive use of fluid results in pulmonary complications.     Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation.     The investigators hypothesized that the assessment by transesophageal echocardiography (TEE)     of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict     fluid responsiveness in patients receiving one-lung ventilation.      This retrospective, observational, single center study was from January 2014 to December     2015. The investigators included 105 patients requiring one lung ventilation lung resection.     The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of     crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining     400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the     VTI above 15% after infusion of 500 ml of crystalloid.   "
32674|NCT02858076|"     Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause     acute and dramatic vision loss for patients with diabetes, there is no current,     evidence-based clinical guidance as to what treatment method is most likely to provide the     best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial     growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each     provide the opportunity to stabilize or regress retinal neovascularization. However, clinical     trials are lacking to elucidate the relative time frame of visual recovery or final visual     outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic     Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent     with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including     greater visual acuity improvement and reduced rates of recurrent VH as compared with saline     injection. It is possible that a study with a longer duration of follow-up with structured     anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to     avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the     other hand, advances in surgical techniques leading to faster operative times, quicker     patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive     alternative since it results in the immediate ability to clear hemorrhage and to perform PRP     if desired, often as part of one procedure. This proposed study will evaluate the safety and     efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and     intravitreous aflibercept injections.   "
32675|NCT02858063|"     -  Selection of patient and preparation of questionnaires        -  Presentation of the study by the doctor        -  Verbal consent of participants (patient and Partner)        -  Delivery of booklets        -  Response to documents (questionnaires and written consent) at home, send by mail   "
32676|NCT02858050|"     The study will look at real-times adhernce monitoring with Portal-724 MEMS cap. It integrates     medication bottle, Smart Cap, Pill Dispenser, Embedded Computer, Embedded Cellular Modem and     Tamper Proof apparatus. This device is capable of transmitting pill dispensing events from     the patient's home to the Cloud over Cellular and IP networks. The transmission is done in     real time if cellular coverage is above 1-bar, but if cell is not available or if the signal     is below threshold, then the device Store-and-Forward feature is automatically activated..     Patient will be randmized to real-time monitoring or to have monitoring data download monthly     at each study visit while taking hepatitis C medications   "
32678|NCT02858024|"     A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative     Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine,     Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine   "
32679|NCT02858011|"     In the last two decades, cash transfer (CT) programs have emerged as a popular approach to     long-term poverty alleviation. While the main goal of cash transfer programs is to reduce     poverty, they also have the potential to improve many development outcomes, such as health     and education.      While many studies, mainly in Latin America and Asia, have investigated the impacts of CTs on     poverty and food security and have, for the most part, found positive impacts, less is known     about the impacts of CTs in Africa south of the Sahara, and, in particular, West Africa.     Moreover, despite the fact that cash transfers have been shown to lead to decreases in     poverty, improvements in household food security, and increases in health service     utilization, impacts on children's nutritional status (including anthropometric measures) are     generally small (Manley, Gitter, and Slavchevska 2013). Consequently, policymakers and     governments are left with the question of how to design social safety nets, such as cash     transfers, to achieve greater impact on diet quality, health, and nutrition.      The overall goal of this research is to generate evidence and knowledge on an integrated     program implemented by the Government of Mali that includes a combination of cash transfers     and targeted nutrition interventions. The information generated will inform program     implementers and policymakers about best options to improve food security and nutrition among     vulnerable groups and individuals in West Africa. Specifically, the main objectives of the     research are        1. To provide evidence on the contribution of integrated social transfer programs to          enhancing household welfare, food security, dietary diversity, and maternal and child          nutrition in West Africa.        2. To test different features and combinations of cash transfers with targeted nutrition          interventions, and assess their impact on food security and maternal and child nutrition          and health outcomes in Mali.        3. To generate knowledge regarding the pathways of impact of these different program          packages, identify the most effective and efficient modalities in the context of Mali,          and derive lessons learned for other countries in the region.      The research entails two study designs: i) a repeated cross-sectional survey (baseline,     midline and endline) in a sample of 1,440 children between 6 and 24 months of age, mainly to     asses the program's impact on child nutrition and health outcomes; ii) a panel study     following a cohort of 2,880 children over 3 years mainly focusing on the evaluation of     household welfare outcomes. The study will be conducted in the 96 communes where the     Jigisemejiri program is being implemented, situated in 5 regions of Mali: Sikasso, Koulikoro,     Segou, Mopti and Kayes.   "
32680|NCT02857998|"     A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523     in Patients With Relapsed or Refractory Mature B-cell Neoplasms   "
32706|NCT02857660|"     The aim of the study is to determine the effect of 16 weeks of Whole     Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO)     in community dwelling male subjects 70+ with SO .      108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein (3)     sedentary control group.      WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar     current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be     adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg     body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score   "
32681|NCT02857985|"     The size of the infarct is particularly important prognostic marker. It is clearly     established that the extent of the infarct is not only correlated to mortality, but also     long-term adverse events. The evaluation of the infarct size at the acute phase of the     disease is therefore an essential clinical tool to adapt the immediate treatment and     follow-up of patients. It is therefore crucial to have techniques that are effective,     precise, reproducible, and easily performed during the acute phase to quantify the size of     the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the     standard examinations for the evaluation of infarct size. However, these exams are difficult     to perform during the acute phase of the infarct owing to difficulties in monitoring unstable     patients and the limited availability of the apparatus. It is for this reason that the     investigators would like to investigate the rotational angiography (RA), which is comparable     to a scanner in its mode of action but does not require transfer of patients as performed     using the same apparatus that used for diagnostic coronarography and therapeutic angioplasty.     RA is a radiological technique that uses the system employed for coronagraph, and consists     rotating the fixed C-Arm around the patient and acquisition of a series of images that are     then reconstituted. The investigators propose to evaluate the size of the infarct using RA in     comparison with cardiac MRI (standard examination) performed as soon as possible after RA and     the investigators hope to demonstrated that RA allows the measurement of an infarct as     precisely as cardiac MRI.   "
32682|NCT02857972|"     General objective:      To assess the preference and performance in terms of satisfaction and acceptability as well     as safety profile of a novel innovative design of menstrual hygiene device (Wondaleaf®)     during the night for menstruating women by comparing it to prior experience of the usual     hygienic product for menstrual control, i.e. sanitary pads.      Specific objectives:        -  To determine the preference of participants between Wondaleaf® and usual sanitary pads          as a night use menstrual hygiene product.        -  To determine the satisfaction of participants towards Wondaleaf® and usual sanitary pads          as a night use menstrual hygiene product.        -  To determine the acceptability of participants towards Wondaleaf® as a night use          menstrual hygiene product.        -  To determine the safety profile of the Wondaleaf®.   "
32683|NCT02857959|"     The purpose of this study is to observe the serological response to 1 or 3 weekly doses of     benzathine penicillin G in patients with early syphilis.   "
32684|NCT02857946|"     An open label randomized, single dose, two-way crossover bioequivalence study to determine     the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals     & Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International     GmbH, Germany) after a single oral dose administration of each to healthy adults under     fasting conditions   "
32685|NCT02857933|"     The purpose of this study is to determine the optimal frequency and intensity of physical     therapy for children with cerebral palsy aged 6 to 24 months of age. Participants will be     randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy.     Short and long term effects will be evaluated to determine the best 'dose' of rehabilitation     for children with cerebral palsy, including frequency (number of sessions per week and the     number of weeks), intensity (how hard the patient works), and time (how many total hours) of     rehabilitation treatment.   "
32686|NCT02857920|"     The aim of this study is the safety and efficacy of Bevacizumab plus natural killer (NK)     immunotherapy to many kinds of recurrent solid tumors.   "
32687|NCT02857907|"     The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune     senescence. Markers of immune senescence expression is assessed in a prospective cohort of     renal transplant recipients the day of transplantation and one year after renal     transplantation.   "
32688|NCT02857894|"     Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by     vascular abnormalities of the walls of small choroidal vessels, reproducing the specific     aspect of polyps (cluster aspect). PCV is one of the boundary-forms of age related macular     degeneration.      These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and     occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients would     present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions have     been induced by radiotherapy treatment and may show an increased sensibility to radiation in     these patients.      Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in     relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic     lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering the     iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it     seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM     gene.      Considering the frequency of PCV worldwide, it seems important to identify the predisposing     genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer     prevention (reinforced protection against radiations, including light) and to develop     therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular     control of DNA).   "
32689|NCT02857881|"     Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology,     characterized by a progressive corneal thinning. This disease leads to a bombing of the     cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity     sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL)     and simple corneal de-epithelization are two common surgical technics aiming to slow the     progression of this pathology. They consist in rigidifying the corneal structure in order to     stabilize its deformation progression. Even though these technics are commonly performed,     none of these strategies has proven their efficiency. The effects of CXL can be due to the     superficial scarring reaction as well as the effects of corneal remodeling induced by the     de-epithelization phase during a CXL procedure, and not due to the covalent links between     collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition     in the presence of Riboflavine De-epithelization may be an equally effective treatment, when     compared to CXL, but without long term secondary effects. Its association with a therapeutic     photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate     its opacities in order to recuperate the transparency of the cornea) will aim to improve the     regularity of the anterior corneal surface, thus allowing a better epithelial attachment     (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of     corneal biomechanics. PKT is a reliable technic; however it has not yet proven its efficiency     in the treatment of keratoconus.      The purpose of this study is to describe the effects of de-epithelization associated with a     therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the     proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1     year, after an intervention of de-epithelization associated with therapeutic     photokeratectomy.   "
32690|NCT02857868|"     The main purpose of this study is to evaluate the effect of varying degrees of impaired     hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after     a single oral dose.   "
32693|NCT02857829|"     Achieving optimal concentration during cognitively demanding tasks is of immense human value.     Despite our understanding of the important role that attention, working memory, and fluid     intelligence play in professional success, and the huge individual differences in these     constructs, the modulation of these cognitive domains has not been rigorously studied. From     the widespread use of caffeine, to the more questionable and increasing use of prescription     medications to achieve peak attention, the tremendous interest in achieving cognitive     performance has driven individuals to experiment, often with prescription and illegal drugs.     Herein, we aim to standardize and extend the study of attention modulating substances, to     identify blends that achieve safe enhancements in attention and working memory. Specific to     this proposal, we aim to develop SPRINT, a blend of natural and generally regarded as safe     compounds to improve attention and working memory in normal, healthy individuals. SPRINT is     composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg),     pyridoxine (0.06 mg), and cobalamin (20 mg).   "
32694|NCT02857816|"     To evaluate the NURO system for the treatment of OAB in drug naïve patients.   "
32695|NCT02857803|"     Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more     ecologically valid context. The purpose of this study is to determine whether this     methodology has more impact on stroke rehabilitation than a paper and pencil personalised     program and conventional therapy, which is motor-focused.   "
32696|NCT02857790|"     Percutaneous coronary intervention (PCI) with adjunctive high speed rotational atherectomy     (HSRA) is commonly used to treat complex and calcified coronary artery stenoses.     Theoretically, HSRA may have deleterious effects on the coronary microcirculation and result     in peri-procedural myocardial infarction (Type 4a MI).      This study is assessing the effects of HSRA PCI using serial multi-parametric stress     perfusion cardiac magnetic resonance imaging (CMR) (1.5 Tesla MAGNETOM Avanto, Siemens     Healthcare). The study will prospectively enrol up to 75 patients (minimum completed cohort     of 50 patients) undergoing elective HSRA PCI and performing multi-parametric CMR at 3     time-points: before HSRA, 1 week post-HSRA, and 6 months post-HSRA. Myocardial perfusion will     be assessed using pharmacological stress with intravenous adenosine (140 micrograms/kg/min)     at each time point. High-sensitivity cardiac troponin (hsTn) and ECGs will be performed     post-HSRA.   "
32697|NCT02857777|"     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of     intranasally administered esketamine in elderly Japanese subjects and healthy younger adult     Japanese subjects.   "
32699|NCT02857751|"     The current study evaluates psychological and physical health outcomes for active-duty     service members following participation in an established surf therapy program. Participants     complete assessments before and after the surf therapy program, as well as brief assessments     before and after each surf therapy session.   "
32700|NCT02857738|"     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection     Factor (SPF) on the skin of human subjects.   "
32701|NCT02857725|"     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection     Factor (SPF) on the skin of human subjects.   "
32702|NCT02857712|"     SGCs are rare (less than 1% of head and neck cancers) and include many malignant histotypes.     SGCs are treated mainly with surgery, followed by radiotherapy in selected cases.     Chemotherapy is reserved for palliative treatment of metastases or local recurrence but     results in term of response rate are very low. Adenoid cystic cancer (ACC) is the most common     SGC histotype observed in metastatic subjects while the other histotypes (non-ACC) such as     mucoepidermoid cancer (MEC), salivary duct gland cancer, adenocarcinoma, myoepithelial     carcinoma are more uncommon. A phase II trial with sorafenib carried out in 37 subjects (19     ACC and 18 non-ACC) with recurrent and/or metastatic SGCs showed a response rate of 16% (11%     in ACC and 22% in non-ACC). In preclinical models, VEGF seems to contribute to tumor     aggressiveness and to distant metastatization of SGCs, in particular in ACC and MEC.     Remarkably three confirmed partial responses, one ACC, one renal cancer and one lung cancer,     on 36 patients were observed in a phase I study with Inlyta, a potent VEGFR     specific-inhibitor approved by FDA as second line treatment for renal cancer. Based on these     data, we want to test Inlyta in patients with relapsed and/or metastatic SGC.   "
32703|NCT02857699|"     A prospective cohort of 250 patients with solid tumours included in phase I clinical trials     of targeted agents will be enrolled. Patients will be treated with MTA in mono therapy or in     association with chemotherapy or other targeted agents in 4 large phase I centers.      Patients from trials investigating chemotherapy alone will not be included. Quality of life     will be assessed during the treatment period.   "
32704|NCT02857686|"     The safety and effectiveness of the mini-dose Bier block, a technique of i.v. regional     anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated     in the emergency department treatment of pediatric upper extremity fractures and     dislocations.   "
32705|NCT02857673|"     Child maltreatment, particularly neglect, disproportionally affects low-income children with     special health care needs (CSHCN) and has serious short and long-term consequences.     Currently, few replicable, evidence-based preventive services exist for such families,     particularly within the context of the patient-centered medical home. Child Abuse Prevention     Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and     protective factors for child neglect, has the potential to improve key parenting skills and     overall wellbeing, ultimately improving outcomes for high-risk children. This study is a     multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child     neglect, adherence to recommended medical care, and family stressors and strengths.   "
32728|NCT02857374|"     This pilot clinical trial studies intravital microscopy in identifying tumor vessels in     patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining     sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn     specific information regarding how melanoma may spread to lymph nodes and other sites of the     body.   "
32707|NCT02857647|"     An interventional prospective study on 200 bariatric surgery candidates from the Assuta     Medical Center (AMC). The first 100 patients will be assigned to the control group and the     later 100 patients will be assigned to the experimental group. All the participants will     receive standard care, and only those participants who will assigned to the experimental     group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the     surgery date. The videotaped lecture will include information and guidelines of bariatric     surgery preparation. All participants will complete Bariatric surgery knowledge questionnaire     and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and     once again at the pre-surgery clinic which take place 1-10 days pre-surgery.In addition, 20     participants will be recruited to a pilot study for the validation of the Bariatric surgery     knowledge questionnaire.   "
32708|NCT02857634|"     Bladder cancer is one of the most common cancer worldwide and the second most frequent     urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has     improved tumor detection but with a high false positive rate. Indeed, the main limitation of     the PDD is its lack of specificity, ranging from 35 to 66%. The association of this technique     with new technologies such as the Cellvizio Dual Band featuring simultaneous dual wavelength     illumination and detection, could improve the identification of tumoral lesions. The     objective of this study is to demonstrate the efficacy of Cellvizio dual band technique for     the diagnosis of tumors bladders.   "
32718|NCT02857504|"     One lung ventilation (OLV) has become a standard procedure for the vast majority of     interventions in pulmonary surgery. It is used in both techniques: thoracotomy and     videothoracoscopy (VATS).      OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the     investigators want to find out if there is any advantage with one or another.   "
32709|NCT02857621|"     Lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid     in interstitial spaces. It is a progressive chronic disease and without appropriate     management may result in serious complications. In Israel, patients are referred to     physiotherapists certified in treatment for lymphedema. According to the International     Society of Lymphology (ISL) the best treatment is a holistic, multidiscipline approach.     Amongst the different methods of lymphedema management, the use of compression is the only     treatment that has shown to be effective in randomized controlled trials.      The ISL recommends that patients with lymphedema in the lower limb ought to bandage their leg     with multi-layer bandaging on a daily basis for a period of two to four weeks. A new     classification system for compression bandages was recommended; pressure of <20 mmHg was     categorized as mild, 20-40 mmHg as medium, 40-60 mmHg as strong and ≥60 mmHg as very strong.     In patients with leg edema, bandages with strong pressure were shown to be the most     effective. However, in the presence of a venous ulcer on a lymphatic leg, pressure between 35     and 45 mmHg is the widely accepted range for sufficient and safe compression. The use of     measurement instruments is currently the only realistic method for determining the actual     pressure achieved beneath the bandage. However, it is neither economical nor feasib¬le nor is     it realistic in terms of time.      Recent studies show that many healthcare professionals use inadequate sub-bandage pressure.     No study so far has focused on therapists that are trained in lymphatic treatment. In spite     of correct pressure bandaging importance, the question whether physiotherapists succeed in     correctly applying it is left unanswered. The main purpose of this study is to evaluate the     pressure applying efficiency in multi-layer bandaging among physiotherapists in Israel who     treat lymphedema.      34 physiotherapists trained in lymphatic treatment will be recruited for this research. Each     volunteer will receive a questionnaire concerning their self-perceived competence in the     application of compression bandages. Afterwards, two practical trials will be held a week     apart in which the subjects will be asked to apply bandages using strong and medium pressure.     Using PicoPress®, pressure will be measured directly after bandaging and two hours later. Our     hypothesis is that the majority of therapists will properly apply medium or strong pressure     on the lower limbs.   "
32710|NCT02857608|"     Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the     detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.   "
32711|NCT02857595|"     Behavioral lifestyle treatment for obesity produces clinically significant weight loss and     corresponding improvements in disease risk and severity when delivered via in-person group     and/or individual treatment sessions. Online versions have been developed in order to reduce     costs. These programs typically include weekly weight loss lessons and tailored feedback on     patients' weight loss progress. However, online programs often produce suboptimal outcomes     compared to programs delivered in-person due to insufficient adherence to prescribed     behavioral strategies, and a lack of objective methods for behavioral self-monitoring to     support adherence. One approach to monitoring and improving adherence involves tracking     patients' weight loss progress on a personalized nomogram (i.e., graph). The nomogram is     based on a dynamic energy balance equation and depicts the expected weight loss over time if     the participant is adherent to a prescribed goal for caloric intake and physical activity. A     complementary approach to measuring and intervening on adherence involves the use of mobile     technology to monitor eating behavior. The Bite Counter is a wrist-worn device similar to a     wristwatch that measures the timing, frequency, rate, and duration of eating events by     monitoring the wrist roll motion that occurs when food is brought to the mouth. By using     mathematical models to calibrate the Bite Counter to the weight loss nomogram, it may be     possible to identify the optimal number of bites that any given patient should take each day     in order to facilitate weight loss. The purpose of the proposed study is to conduct a small     randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy     of adding weight loss nomograms and the Bite Counter to an established online weight loss     program. A sample of 30 participants with overweight/obesity will be randomly assigned in     equal proportions to one of three 12-week weight loss programs: (a) online behavioral weight     loss treatment alone (OBWL), (b) online behavioral weight loss treatment plus the provision     of weight loss nomograms with weekly feedback tailored to the nomogram (OBWL+N), or (c)     online behavioral weight loss treatment plus the provision of weight loss nomograms with     weekly feedback tailored to the nomogram and provision of a Bite Counter that can be used to     alert participants when they are approaching their maximum number of prescribed bites per day     (OBWL+N&BC).   "
32712|NCT02857582|"     Patients who have received antibiotics and thereafter developed diarrhea are investigated for     presence of Clostridium difficile toxin. Primary treatment is given with oral     metronidazole/vancomycin. In case of relapse, secondary treatment is given with either     cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where     secondary treatment with vancomycin fails cultured gut microbiota is given as final     treatment. As an extension treatment, all failures were treated with cluttered gut microbiota     through the upper route. In both cases As an alternative cultured gut microbiota may be given     via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and     stool collection for analysis of Clostridium difficile.   "
32713|NCT02857569|"     The study is a randomized Phase I/II trial aiming to evaluate the 6 month treatment tolerance     defined as the related grade 3-4 toxicity event-free survival and clinical activity of the     combination therapy IT ipilimumab + IV nivolumab.      The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an internal     control to interpret the results obtained in the IT ipilimumab arm.   "
32714|NCT02857556|"     The principal objective of this study is to qualify markers of oxidative stress in     inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and     patients with end-stage kidney failure (diabetic or not), who require dialysis. The     evaluation of these markers will be done by the activation and localization of proteins     implicated in vascular tone and oxidative stress in monocytes, correlated with the     distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to     describe their evolution under treatment, which could lead to interventional studies.   "
32729|NCT02857361|"     The study will look at whether it is preferable to administer two wafers simultaneously or     separately.   "
32730|NCT02857348|"     The objective of this study is to compare the efficacy of a video game designed to     recalibrate physician heuristics in trauma triage with a standard educational program.   "
32715|NCT02857543|"     The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA     and MED in obese (BMI >95%) children ages 9-18 with hypercholesterolemia (>169 mg/dl) and a     parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity     Registry. When possible, in-person discussions or phone calls with their primary or tertiary     care physicians will introduce eligible patients and their parents to the study. All eligible     patients and parents will receive letters describing the study and requesting their     participation. Subjects can choose not to participate in the study, and their health care     will not be affected in any way. Subjects not participating will be asked if they are willing     to answer a brief questionnaire about why they chose not to participate. The proposed study     will be carried out for a total of 52 weeks. The investigators expect to recruit a total of     180 participants (30 children and 30 parents/guardians in each of the three groups). Each     child and parent/guardian pair will be randomly assigned to either PB no-added-fat, AHA or     MED.   "
32716|NCT02857530|"     Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic     anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II     phase, multi-center clinical research.   "
32717|NCT02857517|"     The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular     endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.   "
44220|NCT02706886|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of single- and multiple-ascending doses of ALN-GO1 in healthy adult     volunteers and subjects with PH1.   "
32719|NCT02857491|"     Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana     vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal     detachment. This study will compare intravitreal injection of anti-vascular endothelial     growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus     is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge     related complications.   "
32720|NCT02857478|"     The objective of this study was to assess the safety and appropriateness of a sunscreen     product for use on sport users, under supervised outdoor-use conditions. The study was     conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated     swimming pool facility.   "
32721|NCT02857465|"     To assess the efficacy of epidural dexamethasone administration, compared to placebo, in     reducing local anesthetics consumption during labor epidural analgesia in parturient women   "
32722|NCT02857452|"     The evaluation of lupus patients must include several approaches, in particular disease     activity and quality of life.      The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to     evaluate disease activity. It has the advantage of being inexpensive, easy to use in large     cohorts and has been used in several studies. It has never been validated in French. The     Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is     specific to systemic lupus erythematous; it was developed from interviews with patients.      This tool, validated in a British population, has never been validated in French.   "
32723|NCT02857439|"     What combination of ≤ 6 clinical variables will give the highest specificity for indicating     significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%?      Although shoulder trauma is a common injury, there is no clinical decision rule to determine     the necessity for radiography for these traumas. With this trial the investigators aim to     develop such a rule to reduce the amount of radiographs without missing any significant     injuries.      The primary objective is to compose a set of clinical diagnostic criteria predictive of     shoulder fractures or dislocations that would reduce the amount of radiographs without     missing any significant injuries. A second objective is to determine if the clinical decision     rule is applicable for triage use.   "
32724|NCT02857426|"     The purpose of this study is to determine whether Nivolumab is effective in the treatment of     Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory     Primary Testicular Lymphoma (PTL)   "
32725|NCT02857413|"     The aim of this study is the evaluation of the frequency of xerostomia and their management     after radiotherapy in head and neck cancer.      The quality of life of these patients is also analysed with European Organization for     Research and Treatment of Cancer Quality of life Questionnaire H&N35 (EORTC QLQ H&N35).   "
32726|NCT02857400|"     Prospective, open label, randomized and multicentric study evaluating the efficacy of an     organized consultation return home compared to a current standard of care in patient     hospitalized due to metastatic solid tumor cancer.      Subject will be randomized (1:1) as described below :      • Arm A (standard) : current standard of care ; connection documentation faxed to GP (     General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO standard     of care, organized consultation return home between patient, GP DESC (diploma of     complementary specialized study) and patient's referent GP   "
32727|NCT02857387|"     Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins     grouped under the name of  non-enzymatic post-translational modifications . They often     correspond to the irreversible binding of glucose or other oses (glycation) or urea     derivatives (carbamylation) on proteins and lead to the formation of complex compounds     (post-translational modifications derived products, PTMD) that can accumulate in tissues and     be responsible for deleterious effects. The specific role of these compounds in the     pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and     cellular mechanisms implicated.      This project is based on the hypothesis that non-enzymatic post-translational modifications     may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD     could therefore constitute relevant biomarkers in this specific clinical situation.      To explore these potential new biomarkers, the investigators designed a study in patients     having experienced an acute coronary syndrome and followed during a year. The concentrations     of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and     evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac     rehabilitation will be assessed.      This should help to identify new (and non-traditional) biomarkers of coronary heart disease     and determine some of the implicated pathophysiological mechanisms.   "
32732|NCT02857322|"     The experimental strategy is to develop a specific device about the anesthetic and surgical     acts for a subject with a documented psychiatric condition and to benefit from surgery. This     device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative     phase. A nurse anesthetist will come into contact with the subject the day before surgery.     This contact will be concomitant with the pre-anesthesia visit. She explained about the     general organization of the arrival in the operating room. The interview will be a minimum of     15 minutes and beyond if necessary. This will be accompanying this the next day in the     operating room in order to optimize its hospitality and installing the block, guide the     subject through all the steps before falling asleep. Finally, even accompanying will be     present upon awakening the subject in the recovery room.   "
32733|NCT02857309|"     The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM)     in the heart failure population with ejection fraction ranging between 25 and 45%. The study     is designed in an adaptive manner to ensure proper statistical significance and power of the     primary efficacy evaluation.   "
32743|NCT02857179|"     The aim of this cohort study is to collect prospectively clinical data on all the patients     admitted in the investigators department for bariatric surgery or for any complication of a     bariatric procedure. The investigators goal is not only to improve the follow-up but also to     assess and publish the investigators results regarding weight loss and the complication rate.   "
32744|NCT02857166|"     The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity     (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with     advanced solid tumors.   "
32734|NCT02857296|"     The research project aims to analyze the implementation of a new health care system -     alternative device to hospitalization and crisis home for people without home - whose     objective is to provide the homeless and suffering from severe psychiatric disorders adequate     care to prevent situations from seeking care or complication of their disease. This device,     if it has the administrative and legal structure of the Twin Stop Health Care (LHSS), is     based on the original concept of Soteria House. This will build tools for evaluating the     performance of care device by a process evaluation describing and analyzing what activity     involves the device, This research seeks to analyze the experimental device in the early     stages of its implementation. The observation and analysis of the program period will adjust     the management arrangements of the device. The data and conclusions from this research will     identify the contributions and benefits of such a device and analyze the difficulties     encountered in its implementation.   "
32735|NCT02857283|"     To investigate if low level ozone exposure will cause measurable inflammation in nasal cells.   "
32736|NCT02857270|"     The purpose of this study is to determine the safety of an extracellular signal regulated     kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in     participants with advanced cancer.   "
32737|NCT02857257|"     Patients with irritable bowel syndrome (IBS) are treated with microbiota from a human     intestinal anaerobic sample cultured for decades. Patients are recruited consecutively with     symptoms of IBS and serve as their own controls. After an observation time of 4 weeks,     patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by     the duodenal route via gastroscopy. Two treatments are given within a 1-week interval.     Assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks).     Additionally, fecal samples are collected for bacterial 16S ribosomal ribonucleic acid (rRNA)     analysis and bacterial functional parameters (microflora-associated characteristics).   "
32738|NCT02857244|"     The study team proposes to treat Parkinson's patients with gait difficulty with     multidisciplinary approach of medications. Single medication treatment, such as the use of     cholinergic-boosting anti-dementia medication targeting cholinergic deficiency to improve     executive dysfunction and attention deficit, or the use of medication boosting the     norepinephrine system, have not proven effective so far in treating the gait difficulty.     Anti-anxiety medications, particularly the SNRI (serotonin and norepinephrine reuptake     inhibitor) medications, which also ameliorate the norepinephrinergic deficiency, have not     been studied except for one successful case report using duloxetine to treat primary     progressive freezing of gait.      Targeting multiple mechanisms at same time, such as the combination of a SNRI antianxiety     medication (also boosting the norepinephrine system, such as duloxetine) with an     anti-dementia medication correcting the cholinergic deficiency (such as donepezil), or     targeting a new mechanism, such as the use of anti-GABAergic medication targeting the area     responsible for gait and sleep cycle (pedunculopontine nucleus area, PPNa) should be tried.      Therefore, a collaboration of multidisciplinary teams among the neurology movement disorder     team and cognition and sleep team, and psychiatry team is essential, which has not been tried     before in studying and treating the challenging gait difficulty in Parkinson patients.   "
32739|NCT02857231|"     Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to     impedance parameters as measured by ImpediMed's BIS technology.   "
32740|NCT02857218|"     This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging     (MRI) works in imaging lymph nodes in patients with stage IIB-IIIC esophageal cancer.     Ferumoxytol is a form of very small iron particles that are taken up by cells in normal lymph     nodes and may work better in imaging patients with esophageal cancer when paired with MRI.   "
32741|NCT02857205|"     Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest     cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of     parasympathetic control of the distal bowel from the anal sphincter to various levels. The     most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is     around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic     segment.      Regardless of the surgical complications, patients with Hirschsprung disease are exposed to     the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is     responsible to a major part of Hirschsprung disease morbimortality. Its onset is more     frequent during the first two years of life and then decrease with age.      Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that     involves microbiota, intestinal barrier, immune system and enteric nervous system. This     breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be     responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the     pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients     limit any conclusion or clinical use.      We hypothesize microbiota is a major factor in HAEC onset and in their functional bowel     problems. Considering HAEC is more frequent the first two years, we think intestinal     microbiota changes with time in those patients. This project is innovative because we will     use high throughput sequencing methods and analysis for microbiome analysis on fecal samples     from a multicenter cohort of patients at various ages.      Multicentre transversal study.      This study has the potential to significantly modify clinical practice for Hirschsprung     disease patients: a better care for HAEC and functional troubles thanks to a better     understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic     treatment of patients at high risk of HAEC.   "
33079|NCT02852785|"     The main purpose of this study is to characterize and compare the 3D shoulder kinematics     bilaterally while performing functional movement patterns tests that hypothetically replicate     the 5 main phases of the throwing cycle. The tests are based on diagonal D2 for flexion     (early and late cocking of the arm) and D2 for extension (acceleration, deceleration and     follow-through of the arm) of the upper extremity of proprioceptive neuromuscular     facilitation techniques.   "
32742|NCT02857192|"     Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The     investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17     response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are     to date no data concerning their precise phenotypic and functional characteristics and     notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the     investigator is that, in GCA, there is quantitative and above all functional deficit of Treg.     Recently, progress has been made in the identification of Treg with new markers (CD39), which     will make it possible to better identify and to study their specific functions. In this study     the phenotypic and functional characteristics of Treg in GCA will be analysed. Better     understanding of the role des Treg in GCA should lead to better-targeted treatments for     patients with GCA, notably via the blockage of cytokines that inhibit the differentiation     and/or function of Treg.      The study is classified interventional because a lot of blood samples are taken.   "
32745|NCT02857153|"     This will be a multicentre, randomised, controlled and prospective clinical trial. All     participants provided their written informed consent to participate in a randomized trial     that examined the effects of low-level MAP (60-70 mmHg) vs. high-level MAP (90-100 mmHg) in     elderly patients (65 or more years of age) during noncardiothoracic surgery under general     anesthesia. The investigators hypothesise high-level blood presure of the intervention for     reducing the incidence of post-operative complications.   "
32746|NCT02857127|"     A quasi experimental study evaluating the effectiveness of a walking program at primary     health care settings in a low-income area   "
32747|NCT02857114|"     Measure the impact of touch relaxation on pain communicative patients suffering from chronic     pain of cancer origin inpatient Oncology. measure over three days the effects on pain anxiety     welfare and consumption of analgesics   "
32748|NCT02857101|"     The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of     cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The     determination of calprotectin in ascites, used for the diagnosis of infection of ascitic     liquid, could allow the diagnosis in a very short time (about 30 minutes). To date, the     determination of calprotectin in ascites was not evaluated properly. The investigators would     thus evaluate the interest of the determination of calprotectin in ascites for the rapid     diagnosis of ISLA in cirrhotic patients, like you, hospitalized for decompensation of their     disease. The main purpose of this pilot study will determine the optimal threshold     calprotectin in ascites for diagnosis of ISLA.   "
32749|NCT02857088|"     The study aimed to determine the emotional reactivity of depressed patients to visual and     olfactory stimuli in comparison with healthy volunteers.   "
32750|NCT02857075|"     Every year, several millions of red cell concentrates are transfused. For each of them, a     pretransfusional compatibility test is performed. In France, an ABO compatibility test at the     patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus     antigens are very immunogenic and could lead to Rh incompatibility or Rh disease.      The objective of ABORDAGE project is to develop another biochip that specifically captures     RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.   "
32751|NCT02857062|"     The investigation will evaluate, under dermatological control, the cutaneous in-use tolerance     of E45 Eczema Repair Emollient with two or three times daily application, over a period of     two weeks on children and babies with dry/atopic and very dry/atopic skin.   "
32752|NCT02857049|"     Malnutrition affects until 70% of the patients hospitalized in geriatric's units and     constitutes an independent risk factor of morbidity and mortality. Malnutrition is also     associated with increased length of stay and increased costs, and alters the quality of life.     Oral nutritional supplements (ONS) play a key role in the prevention and treatment of     malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional     supply with a high density of calorie and protein. The clinical efficiency of ONS is well     demonstrated whether on nutritional parameters or on clinical outcomes. However,     acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only 50%     to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple: anorexia,     taste changes, monotony … also partly because patients dislike flavor, taste or texture. The     respect of patients' preferences is essential to improve the therapeutic observance to ONS.     Generally, ONS are delivered after the patient has told his preferences orally to the     dietitian. To date, there is no study evaluating the effect of an alternative strategy based     on a preliminary degustation of several products on the effective consumption of ONS in     geriatrics.      The study is designed as prospective, randomized, controlled, open study to test this     strategy in older undernourished people hospitalized in geriatrics who require prescription     of ONS. This study will be performed among 220 older people hospitalized in two departments     of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille).      The main objective is to compare the therapeutic observance to ONS when products are     delivered to older people according to the usual way (preferences announced orally and/or     dietitian's choice) or according to an alternative strategy based on a preliminary     degustation of several products varying for flavor and texture but always in respect of the     medical prescription. The secondary objective is to compare the evolution of the nutritional     status estimated by routinely used clinical and biological parameters, as well as the main     clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients     will be reevaluated clinically 3 months after the hospital's discharge.      The hypothesis is that a strategy based on a preliminary degustation, leading to an informed     choice, will significantly improve the acceptability and the effective consumption of ONS     during the hospital stay, and will also impact positively the nutritional status at     hospital's discharge and 3 months after. The validation of this hypothesis could allow     recommending the generalization of preliminary degustation of ONS at the time of their     prescription to optimize the therapeutic observance in undernourished older people.   "
32753|NCT02857036|"     The study aims to characterize the rhythmic parameters of unipolar depressed patients that     are associated with the response to antidepressants after 6 weeks of treatment.   "
32830|NCT02856100|"     We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa     (CRPC), so that it may be used to full advantage in supporting existing and emerging     therapies for a spectrum of patients suffering from PCa. In this study we will image patients     with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using     18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring, with correlation to     standard-of-care conventional imaging modalities (CIM) (CT, bone scan) and clinical     follow-up.   "
33108|NCT02852408|"     Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all     over the world for gallstone. Although it has low morbidity, postoperative pain is     challenging situation like every other operation.   "
32754|NCT02857023|"     Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD).     These deficits can significantly disrupt otherwise normal trajectories toward academic and     vocational achievement and negatively impact psychosocial outcomes. Despite widespread     recognition of neurocognitive deficits, there are no treatments shown to maintain or recover     functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a     standard intervention used to stabilize and recover functioning in individuals with     accidental or disease-related brain injury. Recent advances in technology have led to the     development of computerized CT programs. This study seeks to assess the feasibility and     efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents     with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a     randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed).     Feasibility will be assessed by examining participation, retention, and program completion     rates, as well as feedback from a feasibility and acceptability questionnaire and a brief     qualitative interview. Participants will also complete assessments of attention, working     memory, and academic fluency at baseline and immediately following the intervention. A final     assessment will be conducted 6 months after the conclusion of the intervention to evaluate     the stability of treatment effects.   "
32755|NCT02857010|"     Double-blind placebo randomized controlled trial evaluating the clinical efficacy of     allogenic bone marrow derived mesenchymal stem cells in cirrhotic patients with     acute-on-chronic liver failure   "
32757|NCT02856984|"     The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP)     study is to assess the strength of the association between Zika virus infection (ZIKV) during     pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The     study will prospectively enroll a cohort of pregnant women during the first trimester of     pregnancy and follow them through their pregnancy to identify for clinical evidence of acute     ZIKV, while controlling for potential confounders. Outcomes in the women, the developing     fetus, and infants will be assessed. All protocol-specified data will be recorded and entered     in a central data management system for the purposes of analysis of composite data from the     study.   "
32758|NCT02856971|"     Between 2009 and January 2016, the investigators included 49 patients from four hospitals in     Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee     arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive     cohort aims at studying the functional results after 2 years follow up.   "
32759|NCT02856958|"     The purpose of this study is to compare acute nerve decompression versus nonoperative     treatment in the management of peroneal nerve palsy after total knee arthroplasty (TKA). We     hypothesize that acute nerve decompression patients will have better long-term outcomes to     patients treated non-operatively for peroneal nerve palsies after TKA.   "
32760|NCT02856945|"     At this time, there is no standardization for knee trauma care in children. Each physician is     free to resort or not to radiography to verify or dispel bone fracture, depending on     radiographic device availability. This decision is based on trauma severity, clinical     features, and physician experience.      Knee traumatisms are a common reason of consultation. In emergency departments, radiographic     use is widespread for those traumatisms, but not in private practice.      Most of those knee traumatisms includes soft tissue lesion, for which radiography gives no     details. Yet, radiography exposes bone fracture which may require a specific orthopaedic     care. Then, it seems beneficial to highlight simple and reproducible clinical criteria in     order to identify severe knee traumatisms, requiring radiography to assess bone fracture.      Those criteria should have a sensibility close to 1, and the highest specificity. Such     criteria could significantly decrease the number of radiography thus irradiation, emergencies     waiting time, and consultation expenses without missing bone fracture.      Ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated     tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both     immediately and in the emergency department. Presence of one of those criteria required front     and profile radiography to assess bone fracture.      However, few studies have been conducted among children, and they do not confirm the use of     those criteria targeting fracture screening. Data are contradictory and they do not allow     concluding that such criteria could be of benefit for children. Moreover, studies only     consider adults clinical criteria. This study would be the first to implement specific     paediatric criteria, which make this study original.   "
32761|NCT02856932|"     PICOTS:      P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass     Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance     (Functional properties Biological properties) using (World Dental Federation) Fédération     dentaire internationale (FDI) criteria for dental restorations.      T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high     caries risk patients with class I cavities will glass ionomer with glass hybrid technology     has similar clinical performance as conventional high viscosity glass ionomer   "
32762|NCT02856919|"     This study evaluates the efficacy of Mirvaso® in the treatment of chronic persistent vascular     facial erythema, after 4 weeks of treatment, by the Clinician erythema assessment.   "
32763|NCT02856906|"     The purpose of this study is to determine whether what kind of occlusion are related the     orofacial pain under investigation, and whether occlusal adjustment have an effect in relief     of this kind of orofacial pain.   "
32764|NCT02856893|"     The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a     new standard for testing tumor progression compared with conventional radiological procedure     in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during     treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial     will examine the best strategy for delivering osimertinib (upfront versus sequential     treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial     will also explore the mechanisms of acquired resistance to Osimertinib based on the results     of an optional biopsy upon progression.   "
41295|NCT02745093|"     The purpose of this study is to assess the effectiveness, safety, and acceptability of     home-administered medical abortion at gestational age of 8 to ≤9 weeks versus >9 to ≤12 weeks     among a cohort of women in Mexico City.   "
32766|NCT02856867|"     This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II     trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This     study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with     metastatic disease. Patients will have had no previous chemotherapy for metastatic     esophagogastric cancer. Patients will receive nintedanib or placebo in combination with     mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous     infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85 mg/m2     on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib or     placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long as     they have not experienced any adverse events requiring permanent discontinuation of study     medication and have not demonstrated disease progression.      The primary objective is to test the hypothesis that progression free survival (PFS) is     prolonged in HER2-negative patients with untreated metastatic esophagogastric adenocarcinoma     when treated with nintedanib plus modified FOLFOX6 (mFOLFOX6) as compared to placebo plus     mFOLFOX6. The analyses will be performed when 124 events for PFS will have been observed in     the pooled arms.   "
32767|NCT02856854|"     EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone     (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;     now marketed as oxazepam (generic) only).      This Phase 1b cocaine interaction study is being conducted in order to assess the safety and     PK of EMB-001 and cocaine in combination.   "
32768|NCT02856841|"     44 patients were enrolled in this study as they had malignant epithelial ovarian     tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared     to the standard laparotomy surgical staging. Maximal surgical effort for Optimum     cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied   "
32769|NCT02856828|"     The purpose of this study is to evaluate the effectiveness of a novel digital image     enhancement (DIE) technology in reducing the radiation exposure to both the patient and     surgical staff during standard intramedullary nail placement for treatment of hip fractures.     Secondarily, to evaluate whether the image quality and reproducibility of desired images can     be improved with use of the DIE technology. Finally, to evaluate whether DIE technology     reduces total operative time.   "
32770|NCT02856815|"     To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the     patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular     carcinoma   "
32771|NCT02856802|"     A safety and efficacy of DFN-02, being conducted at multiple centers in the United States.   "
32772|NCT02856789|"     The purpose of the study is to give the proof of concept of the Fibrin structure assay on     STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from     the normal population. Secondary objectives are to determine the precision of the assay, to     record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation     activation assay and in a coagulation-lysis assay.   "
32773|NCT02856776|"     There continues to be debate as to how much vitamin D an adult requires to be vitamin D     sufficient. A multitude of association studies have suggested that improving serum 25(OH)D     >30 ng/mL may reduce risk of many chronic illnesses and improve immune function. The aim of     this study is to define dynamic changes in PTH, broad gene expression in circulating immune     cells, metabolomics, and microbiome profile in response to varying doses of vitamin D     supplementation.   "
32774|NCT02856763|"     To identify predictive factors of adalimumab (anti TNF) response in patients with luminal     Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete     resolution of infection.   "
32775|NCT02856750|"     A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for     Adjutant Pain Control Following Acute Rib Fractures.   "
32776|NCT02856737|"     Delirium is an acute disturbance in mental abilities and confusion that affects many patient     in the hospital and is caused by multiple factors including and altered sleep/wake cycles and     multiple sedating medications. Patients in the ICU are particularly susceptible to developing     delirium due to increased noise levels and metabolic derangements.      Numerous studies have shown that delirium can be associated with many negative outcomes,     including longer hospital length of stay, increased time on a ventilator, higher mortality     rates, and greater long-term cognitive dysfunction. There are a series of non-pharmacological     interventions that have been shown to reduce delirium especially in intensive care units.     These include noise reduction, frequent reorientation, reducing unnecessary stimulation at     night, and grouping patient care procedures.      The aim of this study is to evaluate the benefits of eye masks and earplugs (used     concurrently) on reducing delirium and to assess for associated outcomes such as length of     stay, use of sedating medications, morbidity, and mortality. The benefits of this are to     improve sleep quality, and this intervention has been associated with a reduction in the risk     of delirium.   "
32777|NCT02856724|"     This study evaluates the effectiveness and safety of early amniotomy after vaginal     prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early     active phase of labor for early amniotomy group ( half of participants) when the cervix will     dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other     half of participants) until the membranes rupture spontaneously.   "
32778|NCT02856711|"     The investigators propose to evaluate how the CenteringPregnancy curriculum compared with an     enhanced curriculum, with the addition of 2 trauma-informed interventions, affects how new     parents prepare for parenting and respond to common stressors.   "
32779|NCT02856698|"     Acute pulmonary edema (APE) is a common condition in the emergency room, associated with     considerable mortality. The use of intravenous morphine in the treatment of APE remains     controversial and Benzodiazepines have been suggested as an alternative for morphine to     relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in APE     trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate     the efficacy and safety of morphine in patients with APE.   "
32780|NCT02856685|"     This is a Phase 1/2, open-label, multicenter study.   "
33109|NCT02852395|"     This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and     repeated doses, and to evaluate its potential effectiveness for treating insomnia.   "
32786|NCT02856607|"     Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner     surface of the heart), which may include one or more heart valves. Epidemiologic pattern has     changed during the last 20 years whereas the incidence was unchanged. However, the mortality     increase despite recent diagnosis and therapeutic advances.      Only few investigations consider the prognostic and the therapeutic medical care according to     the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis     and medical care are realized in a referent center with cardiac surgery, (ii) patients     secondary addressed to a referent center with cardiac surgery, (iii) patients for which the     totality medical care are performed in non-referent health center. In addition, epidemiologic     studies concern only a part of IE, not including most of the time the patients hospitalized     in non-referent center.      The aim of the study was to determine the prognosis of threated patients according to the     clinical care pathway. Secondary objectives was (i) to evaluate the application of European     recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and     surgical practice, (ii) to compare the epidemiologic profile according to the type of center.      For this, 300 patients addressed in the 22 French participating centers for a possible or     certain IE according to Duke Criteria were prospectively included during 3 years.      Patient data (clinical, demographical, biological, microbiological, echocardiographic and     evolutive data) were collected at the admission, during hospitalization, at discharge and     one-year follow up.   "
32788|NCT02856581|"     This randomized phase III trial studies how well smoking cessation intervention works in     reducing surgical complications in patients with newly diagnosed lung cancer who smoke     cigarettes. This study will use two smoking cessation interventions: Varenicline (a drug that     reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) with     behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco     quitline [tobacco cessation service available through a toll-free telephone number]     follow-up) with placebo (a pill with no active medication) along with the same behavioral     interventions. It is not yet known whether smoking cessation intervention prior to surgery is     effective in reducing surgical complications for these patients.   "
32789|NCT02856568|"     This phase Ib trial studies the side effects and best dose of ricolinostat when given     together with gemcitabine hydrochloride and cisplatin in treating patients with     cholangiocarcinoma that cannot be removed by surgery or has spread to other places in the     body. Ricolinostat may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving ricolinostat together     with gemcitabine hydrochloride and cisplatin may work better in treating patients with     cholangiocarcinoma that cannot be removed by surgery or has spread to other places.   "
32790|NCT02856555|"     The primary objective of this study is to evaluate the safety and tolerability of GS-0976 in     adults with nonalcoholic steatohepatitis (NASH).   "
32791|NCT02856542|"     This study aims to describe the patient population being treated and evaluate their treatment     adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel     Applicator for 4 weeks.   "
32792|NCT02856529|"     Considering the importance of infection control practices, Madinah Public Health Department     launched a new license program for healthcare workers, the Basic Infection Control Skills     License program (BICSL). BICSL has been launched to train healthcare workers all over the     region in a scientific standardized way.      To assess BICSL effectiveness, a non-randomized control study will be conducted in two of the     general hospitals in Madinah. An electronic bilingual self-administrated valid and reliable     questionnaire will be used to evaluate the workers knowledge and practices before and after     three and six months of the intervention. The knowledge and practice answers were scored and     the scores were categorized to facilitate the comparison. A BICSL certified trainer will be     conducting the intervention, a one to one training session. A SPSS program will be used to     analyze the data. Administrative and ethical approval was obtained from Madinah health     authority. The participants will complete an electronic consent before they fill the     questionnaire. Confidentiality and privacy as well as freedom to participate or not will be     insured to all participants. This study will assess the license effectiveness in improve     knowledge and compliance.   "
32793|NCT02856516|"     This will be a randomized, cross-over design. Subjects will be randomized to one of three     interventions on three separate study days, 1 week apart.   "
32794|NCT02856503|"     High-doses of Vitamin D (VD) may be used as targeted therapy against breast cancer. The     investigators will assess the effect of high dose VD on the following biomarkers in the     breast cancer cells: VDR, estrogen receptor (ER), progesterone receptor (PR), epidermal     growth factor receptor 2 (Her2/neu), androgen receptor (AR), as well as epidermal growth     factor receptor 1 (EGFR) and Ki-67, as markers of proliferation, and E-cadherin, a marker of     invasion and metastasis.   "
32795|NCT02855450|"     An 8 Week phase Ib, monocentric, randomized, double-masked, vehicle controlled, parallel     groups, study with a 24 Week follow-up period to evaluate the safety and potential efficacy     of a 180 μg/ml recombinant human nerve growth factor (rhNGF) eye drops solution versus     vehicle in patients with glaucoma.   "
32796|NCT02855437|"     The purpose of this study is to determine the feasibility and acceptability of using     different remote data collection technologies to ascertain flare occurrence among gout     patients. Two technologies will be the focus of this study: a telephone based interactive     voice response (IVR) and a smartphone mobile application (called RheumPRO). The results of     this study will not only guide research approaches in clinical trials, but may also have     direct implications for monitoring patient outcomes in the context of day-to-day clinical     practice.      The investigators hypothesize that acceptability will be greater for RheumPRO application     than IVR. Additionally, the investigators hypothesize that RheumPRO will be associated with a     greater frequency of patient-initiated interactions.   "
32797|NCT02855424|"     Poor cardiopulmonary endurance is observed in individuals with acute stroke, even in chronic.     In addition, the poor fitness may obstacle activities of daily life, decrease activities of     autonomic system, and increase risks of recurrent, therefore, the cardiopulmonary endurance     training should be included into the early-stage rehabilitation program. The ergocycling     training could improve cardiopulmonary endurance for individuals with stroke. Moreover, the     low-intensity exercise training can increase the willingness, and it is safer than the     moderate-intensity exercise training. However, it needs to be evaluated whether the     low-intensity exercise training can bring sufficient benefits, compared to the     moderate-intensity exercise training. Objectives of the study is to compare the exercise     benefits between the low-intensity and moderate-intensity exercise training, and then these     would offer optimal exercise prescription and considerations in clinical practice.   "
32798|NCT02855411|"     The purpose of this study is to determine whether PF-04958242 is safe and effective in the     treatment of cognitive dysfunction in schizophrenia subjects   "
32833|NCT02856061|"     This pilot study examines concurrent and predictive relationships between eye tracking and     clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye     tracking will be comprised of both laboratory-based measures (using a commercial eye-tracking     system) as well as home-based measures (using tablet-based eye tracking systems). The major     goals of this study are both to improve our understanding of the potential role of eye     tracking in clinical trials and to advance technologies that may further improve the     sensitivity, robustness, accessibility, and ultimate utility of eye tracking methodologies.   "
33377|NCT02848898|"     This trial consists of application of little devices (named Equistasi®) generating focal     vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The     expected effects are on gait and postural instability.   "
32799|NCT02855398|"     The purpose of this 18-month project is to investigate how decision-making influences food     choice and consumption in children ages 7 to 11 years old. Although several studies suggest     that the ability to make good decisions relates to eating behaviors, no studies have looked     at how food reward influences the decision-making process to impact actual food intake. This     proposal will answer these questions and bridge this gap in knowledge, which could lead to     the development of more effective interventions for childhood obesity. To accomplish this,     the investigators have assembled a diverse team with expertise in food intake, nutrition, and     decision sciences. First, the investigators will establish if there are differences in     decision-making between children varying in weight status. Second, the investigators will     determine if performance on behavioral decision-making tasks relates to food consumption in     the laboratory. Third, the investigators will examine response functional magnetic resonance     imaging (fMRI) blood-oxygen-level-dependent (BOLD) response to various rewards (i.e. food and     money) and determine if this is influenced by child weight status. Fourth, the investigators     will examine differences in fMRI BOLD at rest in decision-making regions are correlated with     food intake and weight status. Eighty-two children will participate in our study. The     long-term goal of this project is to investigate if there are differences in brain regions     corresponding to these behaviors in overweight children and if these differences relate to     eating behaviors in this population. Children will undergo fMRI while playing a reward task     as well as consume meals in our laboratory. Decision-making will also be assessed by having     children complete various behavioral measurements of reward and inhibitory control.   "
32800|NCT02855385|"     This study sought to find the health seeking behavior of patients with rectal bleeding as     related to their risk to develop colorectal cancer and also assess the general practitioner's     perceived barriers to colonoscopy for patients with bleeding per rectum.   "
32801|NCT02856477|"     The study aims to assess the therapeutic benefits of the adaptation of the antidepressant     dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.      Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the     action time and the after effects.   "
32802|NCT02856464|"     The trial will be conducted as a multicentre open label, randomised prospective phase II     clinical trial in patients with high risk myeloid malignancies.      The primary objective is to evaluate whether prophylactic donor lymphocyte infusions (DLI)     delivered as part of a planned schedule improves the disease free survival of patients with     myeloid malignancies.   "
32803|NCT02856451|"     A case series analysis of encephalitis events reported to the Sponsor for patients treated     with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.   "
32804|NCT02856438|"     The objective of this expanded access program is to provide treatment with elotuzumab in     combination with lenalidomide and dexamethasone for patients with relapsed or refractory     multiple myeloma at Japanese sites where licensed physicians determine clinical need.   "
32805|NCT02856425|"     Both anti-angiogenesis and anti PD1 immunotherapy have shown beneficial efficacy in solid     tumors and in particular in NSCLC. Therefore it is of interest to investigate whether the     combination of these two approaches is tolerable. Moreover, comprehensive pre-clinical and     clinical rationale sustain the hypothesis that anti-VEGF could synergize with immunotherapy     for the benefit of the patients.   "
32806|NCT02856412|"     There is evidence demonstrating that aerobic exercise improves many symptoms of Posttraumatic     Stress Disorder (PTSD) including; anxiety, depression, insomnia, and cognition. With the goal     of using exercise as a rehabilitation therapy for Veterans with PTSD, a team of scientists     and doctors developed a 12-week exercise program, combining aerobic and strength training     with concentration training and mindful breathing techniques. The initial pilot study     suggested that Integrative Exercise may improve overall quality of life, sleep quality,     cardiovascular fitness, and PTSD symptoms. This new study will help determine the     effectiveness of Integrative Exercise compared to health education classes. The overall goal     is to determine if integrative exercise is an effective rehabilitation intervention for     combat Veterans with PTSD.   "
32807|NCT02856399|"     The methadone is an useful opioid for the cancer pain treatment, mostly used in second or     last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians     agree that the methadone could have an effect in neuropathic cancer pain. During a previous     study the investigators find that the pain was still improving after the week 2, but they had     only a small number of patients still included at this stage and they cannot conclude.      The investigators decide to follow up systematically all the patients undergoing a methadone     treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain     improvement.   "
32808|NCT02856386|"     Micronutrients missing in the diet may assist in supporting digestive health in children with     chronic GI issues. This study will monitor changes in symptoms associated with digestive     problems in children provided with a dietary supplement that will be taken in conjunction     with the standard of care.   "
32831|NCT02856087|"     High-dose remifentanil infused intraoperative ironically results in postoperative     hyperalgesia. Ultra-low dose nalxone is demonstrated to prevent these opioid-induced     hyperalgesia in animal model. In this clinical trial in patients undergoing general     anesthesia with remifentanil, we evaluate the effects of ultra-low-dose naloxone on     remifentanil-induced hyperalgesia   "
32834|NCT02856048|"     The purpose of this study is to determine the efficacy of a temporary ovarian suppression     obtained by administration of a gonadotropin releasing hormone agonist during alkylating     agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH)     serum levels in adolescents and young women with cancer.   "
32955|NCT02854397|"     In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE)     to quickly provide the efficient treatment. Currently, there is no specific biomarker for     acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However,     previous works are carried out for that purpose. All the potential candidate biomarkers must     be validated in prospective studies to estimate their specificity and sensitivity values, and     to understand their potential utility in patient care.      The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in     pediatric population, for the differential diagnosis between HAE crisis and angioedema     resulting of mast cell activation crisis (the main differential diagnosis of HAE).   "
32809|NCT02856373|"     Rationale:      Sympathetic activity plays an important role in the pathogenesis of ventricular     tachyarrhythmia. Previous studies have shown evidence of significant heritable influences on     individual responses to adrenergic stimulation. Catheter-based renal sympathetic denervation     (RDN) is a novel treatment option for patients with resistant hypertension, proved to reduce     local and whole-body sympathetic activity. The investigators hypothesize that percutaneous     transluminal electrical stimulation of the sympathetic nerve bundles in the renal arteries     will cause ventricular arrhythmias and renal denervation will suppress these arrhythmias in     patients with sympathetic ventricular arrhythmias.      Objective:      This study will investigate the effects of renal nerve stimulation before and after     percutaneous transluminal RDN on cardiac excitable properties including induction of     ventricular tachy-arrhythmias before and after RDN in six studies, i.e. patients with     catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome and     arrhythmogenic right ventricular cardiomyopathy (ARVC), sympathetically driven ventricular     arrhythmias, hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM) and     ischemic cardiomyopathy (ICM). The aim of the six studies is to assess the anti-arrhythmic     effects of RDN in patients with sympathetic ventricular tachy-arrhythmias.      Study design:      Investigator initiated, multi centre, six pretest-posttest design studies.      Study population:      Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal     pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT     syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-85     year.      Intervention:      RDN will be performed according to routine clinical practice. Prior to the ablation     procedure, catheter mapping of the renal arteries will be performed according to routine     clinical practice. Clinical and biological responses to transluminal electrical renal nerve     stimulation will be assessed before and after RDN.      Study endpoints:        -  Main procedural study endpoint: Induction of ventricular arrhythmias in response to          renal nerve stimulation prior to RDN and absence of renal nerves stimulation induced          ventricular arrhythmias after RDN.        -  Main clinical study endpoint: Development of ventricular arrhythmia during exercise          stress testing performed 6 months after procedure.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      In several studies, it was shown that RDN was safe. The intervention resulted in     significantly better control of blood pressure with less medication, and beneficial changes     in heart rate variability, autonomic sympathetic balance, renal arteriolar function, and a     higher success of atrial fibrillation prevention. In case reports and case series, RDN had a     favourable effect in patients with sympathetic drug refractory ventricular tachy-arrhythmias.   "
32810|NCT02856360|"     The objective of this proposal is to determine the effects of footwear stiffness on a large     cohort of high school football players during a football season. The investigators expect     that functional athlete groups will be developed, based on subject specific assessments     (biomechanical, morphological, performance, comfort), and lead to important translational     findings that may impact footwear modification and recommendation to a population of American     football players. Two standard cleats will be randomized and provided during a season of high     school football. Ratings of comfort, performance, and injury will be collected throughout the     season.   "
32811|NCT02856347|"     The aim of the trial is to study a radiating diagnosis agent used in post surgery when the     biological assessment highlighted a residual disease.      This is an inter-regional multicentric, prospective study evaluating the benefit of PET     F-DOPA imaging in involved node detection compared to standard imaging assessment in patient     with medullary thyroid cancer.      The purpose of the study is to evaluate the impact and performance of a new PET / CT     (computerized tomography ) tracer targeting dopamine receptor in patient with residual     ganglionar biological disease after initial surgery of medullary thyroid cancer compared to     standard imaging.      Obtained data will be compared to the gold standard based on :        -  nodes cytology when they could be punctured        -  histology when a new surgery will be recommended        -  surveillance when the 2 first cases will be not applicable (imaging monitoring,          evolution of thyrocalcitonin)   "
32812|NCT02856334|"     The purpose of this study is to determine if the psychosocial factors in women with chronic     pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors     with central sensitization and dysfunctional pain.   "
32813|NCT02856321|"     A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL)     muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into     this muscle have not yet been described in the literature. Based on the results of a previous     study, the hypothesis is: this muscle may thus constitute a new therapeutic target for     botulinum toxin injections in the early management of spastic equinus in children aged 2     years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break.      The aim of this retrospective study is to describe in intramuscular BoNT (Dysport) injections     into PL based on the results obtained in a cohort of children (approximately 30 subjects)     with cerebral palsy (hemiplegia or diplegia) and which have been treated in the service since     2007 until July 2012.      The investigators results are based on clinical, radiological and video evaluations. For this     study, data will be collected in medical folder of each children belonging to this cohort.      All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which     have been treated by BoNT (Dysport) intramuscular injections into PL in the service between     2007 and July 2012 will be screened. Subjects will be selected according to the following     defined inclusion and exclusion criteria.      Data will be collected retrospectively (using a specific case report form designed for the     study) in medical folder of each included subject for all visit of follow-up after BoNT     (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then, data     will be entered in a database. After that, they will be analysed .   "
32814|NCT02856308|"     This is a prospective, single-arm, multi-center, international, open-label, non-randomized,     clinical study.      The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair     implant device in subjects affected with hair loss.   "
32815|NCT02856295|"     The aim of this study is to compare between anti-10a levels in postpartum women receiving     different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's     weight and the second group receiving 1mg/kg to a maximum dose of 120 mg   "
32816|NCT02856282|"     The purpose is to obtain real-world information on how consumers are complying with the     product labelling This study will coincide with the launch of Pirinase Hayfever Relief for     Adults 0.05% Nasal Spray in the United Kingdom (UK).   "
32817|NCT02856269|"     The purpose of this pilot study is to determine whether zinc supplementation significantly     affects immune activation in HIV-infected subjects.   "
32832|NCT02856074|"     The current management of ischemic stroke is based on different strategies that may be     combined: intravenous thrombolysis in a stroke ICU, intravenous thrombolysis in a     telemedicine procedure, endovascular thrombectomy. Given this now rich therapeutic arsenal,     it seems necessary to evaluate practices in local care in the field and the impact of these     on the prognosis of ischemic stroke victims. The aim of this observational study is to     compare these different care practices without interfering with the choice of strategy.      A blood sample will also be taken at different times to study the value of growth     differentiation factors (GDF) 8, 11 and 15, and Brain-derived Neurotrophic Factor as     prognostic biomarkers   "
33110|NCT02852382|"     This study evaluate the effects of scalp block versus local infiltration on haemodynamic     response to head pin replacement and skin incision and postoperative analgesia in posterior     fossa surgery   "
32818|NCT02856256|"     The choroid is a richly vascularized conjunctive tissue, providing the nutritive elements to     the pigmentary epithelium and the photoreceptors of the retina. It drains 80% of the eye's     blood. The choroidal thickness fluctuates according to the state of fullness of its     constitutive vessels. The choroid and the neuroretina (separate by the pigmentary epithelium)     are intimately linked and are subject to modifications during the ingestion of caffeine and     taurine combined. Several authors have shown a significant decrease of the choroidal     thickness lasting at least 4 hours after the ingestion of a small coffee. This decrease may     be caused by caffeine's vasoconstrictor effect. Taurine is the most abundant amino acid in     the retina. Recent studies have shown the importance of this amino acid in the physiology of     both, retinal pigmentary epithelium and retinal ganglion cells.      RedBull® is an energizing drink, where one single 25 cl can contains 80 mg of caffeine (the     equivalent of a coffee mug) and 1 g of taurine.      This pilot trial aims to study the variations of the choroidal thickness and to describe     possible modifications within the pigmentary epithelium, due to the ingestion of caffeine and     taurine. The results of this study will act as a reference for an ulterior trial aiming     specific choroidal pathologies of young patients, such as the central serous chorioretinitis.   "
32819|NCT02856243|"     Cryoglobulinemia are responsible for systemic vasculitis, and the most frequently targeted     organs are the skin, joints, kidney and peripheral nervous system. Cryoglobulinemia     vasculitides are associated with significant morbidity and mortality, and require therapeutic     intervention. With the discovery of hepatitis C virus (HCV) as the etiologic agent for most     cases of mixed cryoglobulinemia new opportunities and problems for crafting therapy of HCV     mixed cryoglobulinemia (MC) have emerged. A new and major concern was the potential adverse     effects that immunosuppressive therapy with glucocorticoids and cytotoxic drugs could have on     an underlying chronic viral infection. Alternatively the discovery of HCV provided the     opportunity to control HCV-MC with antiviral therapy based on the belief that the underlying     infection was driving immune complex formation and resultant vasculitis. Inducing a sustained     virologic and clinical response and minimizing the use of immunosuppressive drugs are the     main goals in the treatment of patients with HCV-MC vasculitis. Aggressive antiviral therapy     has been shown to induce a complete remission of HCV-MC in up to 70% of patients. New     antiviral combination, Interferon (IFN)-free regimens have recently proved very high     virological response rate and with a very good safety profile and now need to be evaluated in     severe and/or refractory HCV-MC patient's population.   "
32820|NCT02856230|"     Endovascular treatment of below the knee disease is a well-established therapy to improve     outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated     the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel     disease. A successful recanalization of foot artery was related to a higher ulcer healing and     a reduction of major amputation. Moreover absence of revascularization in a patient with     critical limb ischemia is an independent risk factor for mortality. Despite the introduction     of new devices dedicated to below the knee vessel disease treatment, with the development of     guides and conical balloons, long term patency outcomes are still poor. Restenosis was     observed in more than two thirds of patients within 3 months after angioplasty of tibial     arteries with a high target lesions revascularization. These re-interventions are     characterized by a higher morbidity and mortality due to several comorbidities associated to     these patients. These data confirm the need to obtain more lasting results in order to     improve long-term outcomes of these patients.      Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after     angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have     shown controversial results.      The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL     paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb     ischemia.   "
32821|NCT02856217|"     Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the     vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic     organ prolapse and serves as the criterion standard against which other operations are     compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral anterior     longitudinal ligament reinforced with a graft, usually synthetic mesh. More than 225.000     surgeries are performed annually in the United States for pelvic organ prolapse. Abdominal     sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but little is     known about safety and long-term effectiveness.      Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on     lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with     laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for     pelvic organ prolapse.   "
32822|NCT02856204|"     This research trial studies the shotgun sequencing of blood samples in diagnosing febrile     neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients     with acute myeloid leukemia in the laboratory may help identify pathogens and accurately     diagnose infections such as febrile neutropenia.   "
32823|NCT02856191|"     The aim of this pilot study is to determine, as exhaustively as possible thanks to the     continuous and precise recording of heart rhythm, the frequency of de novo atrial     fibrillation in septic shock, which is currently unknown, and to identify specific factors     that could be associated with the condition. These will be investigated more precisely in a     future study. This constitutes the first step in a reflection on the management of Cardiac     Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as     a major prognostic factor for morbimortality, but for which management is uncertain in the     absence of reference data.   "
32824|NCT02856178|"     This study assesses the pharmacokinetics and safety of the new antifungal F901318 in AML     patients.   "
32825|NCT02856165|"     Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to     provide respiratory support in children with moderate to severe bronchiolitis.      However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN     is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of     acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently     the need of PICU transfer.   "
32826|NCT02856152|"     This open-label, randomized, 4-way crossover study in healthy participants will determine the     relative bioavailability of the tablet formulation relative to the capsule formulation and     the effect of a high-fat and low-fat meal on the relative bioavailability of the tablet     formulation.   "
32835|NCT02856035|"     Stroke (795,000/year in the US and 30 million existing stroke survivors in the world) damages     brain neural structures that control coordinated upper limb movement. To most effectively     target the brain damage, interventions should be directed so as to restore brain control     serving coordination of peripheral neuromuscular function. Currently, there is a lack of a     transformative intervention strategy, and only limited efficacy is seen in response to neural     rehabilitation that is only peripherally-directed (limbs e.g.) or only directed at the brain.     This study will employ a novel neural feedback approach with a closed-loop, real-time     paradigm to engage and retrain existing brain function after stroke. Real-time functional     magnetic resonance imaging (rtfMIR) provides neural feedback with the advantage of precisely     identifying the location of brain activity for multiple cognitive and emotional tasks.     However, the rtfMRI is costly and precludes motor learning that requires sitting and engaging     the upper limb in complex motor tasks during imaging acquisition. In contrast, real-time     functional near-infrared spectroscopy (rtfNIRS), although not as spatially precise as rtfMRI,     offers a low-cost, portable solution to provide brain neural feedback during motor learning.     This proposal will utilize both technologies in a hybrid, sequential motor learning protocol.     Moreover, the study protocol will also simultaneously involve both central effective signals     (through neural feedback) and peripheral affective signals by employing neutrally-triggered     functional electrical stimulation (FES)-assisted coordination practice, which produces     peripherally-induced affective signals from muscle and joint receptors. This novel     combination intervention protocol will engage the central nervous system, motor effective     pathway training along with induction of affective signal production (FES-assisted practice),     all of which will be implemented within the framework of evidence-based motor learning     principles.   "
32836|NCT02856022|"     The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation     (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.   "
32837|NCT02856009|"     Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of     aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis.     Patients older than 75 years also show excess mortality. One of the hypotheses to explain     this situation is the high level of frailty in this population. Many tools to measure the     concept of frailty have been developed. One important dimension of these tools is the     nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent     situation, is also a complex phenomenon.      The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a     marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects     older than 75 years hospitalized in Dijon CHU.   "
32838|NCT02855996|"     The Child and Family Research Partnership (CFRP) will be conducting the local evaluation of     AVANCE's Fathers in Action/Padres Activos (FA/PA) fatherhood program. AVANCE is a non-profit     organization that has served low-income families and children since its founding in 1973.     AVANCE sites have been providing fatherhood services for some time, but the programming     offered has varied across sites and no rigorous evaluation of the programs has been     completed. Through a federally-funded Responsible Fatherhood grant, AVANCE aims to create one     fatherhood curriculum to be used across their sites: Fathers in Action/Padres Activos     (FA/PA).      The purpose of the study is to advance the field of knowledge in the area of fatherhood     programing by providing rigorous evidence on the impact of a comprehensive fatherhood program     on enhancing a father's ability to be involved with and parent his child, in addition to     providing more information on the selective characteristics of fathers who choose to     participate in fatherhood programs. The study will seek to answer the following research     questions: (1) What are the demographic and relationship characteristics of fathers who     choose to participate in the Fathers in Action/Padres Actívos (FA/PA) program, and how do     these characteristics compare to the fathers associated with mothers and children in other     AVANCE programs?; (2) Does the FA/PA program positively impact parenting and co-parenting,     father engagement and involvement, and healthy relationship?; (3) Are the program impacts     similar for low-income fathers across regions (Houston v. the Rio Grande Valley),     race/ethnicity (African American v. Hispanic), and coresidential status (nonresident v.     resident)?; and (4) What are the factors that enhance or impede the successful implementation     of the FA/PA program?   "
32839|NCT02855983|"     The specific aim of this study is to determine whether perforating fat injections to the     plantar fascia is a safe method to improve pain, quality of life, and reduce plantar fascia     thickness for patients with chronic plantar fasciitis. We will also correlate the intrinsic     fat properties of adipose stem cells (ie. growth factors) to the improvement in pain, quality     of life, and plantar fascia thickness over time.   "
32840|NCT02855970|"     The aim of this work is to develop and validate a scale adapted to French cultural     characteristics. It will be based on the SS-QoL scale and be simple and quick to use in     everyday practice. It is not simply a translation. This transcultural adaptation requires     linguistic and psychometric validation, by studying its validity, its reliability and its     sensitivity to change, as though it were a new instrument. The investigators will then     develop a short version by reducing the items and conduct a psychometric validation.      The translation and validation of a short French version of the SS-QoL scale will generate a     reliable and sensitive, easy-to-use tool suitable for use in everyday practice.      The final objective is to use this tool as a principal judgement criterion in future     therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic     factors that affect quality of life so as to provide better management of this disease.   "
32841|NCT02855957|"     Our project aims to assess and validate an innovative prognostic and diagnostic test in order     to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a     better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and     iii) follow the evolution of this pool in response to treatment of patients. In the future,     this prognostic test based on the measurement of free α-Hb pool may be suitable for routine     laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group     of 50 healthy volunteers have been recruited.   "
32849|NCT02855853|"     Even though cognitive-motor performances are impaired in frail elderly subjects compared with     healthy elderly subjects, exercising cognitive-motor processes in an implicit manner can     improve the carrying out of real actions in everyday life.      No training programme using virtual reality and serious games oriented towards the     perception/action system has been tested in frail elderly subjects.      The expected results are:        -  In the short term, greater strengthening of motor and cognitive abilities in subjects          trained with the virtual reality and serious games, thanks to stimulation through action          and through the underlying processes.        -  In the long term (+1 and +3 months at the end of the training period) better          preservation of motor and cognitive abilities in subjects who took part in the virtual          reality and serious games programme.   "
32956|NCT02854384|"     This work is intended to assess the effect of -30 minutes- exposure to mobile-phone on the     functions of the central nervous system (CNS) in epileptic patients.   "
32843|NCT02855931|"     Endoscopic sinus surgery (ESS) has become the standard of care for patients suffering of     chronic rhinosinusitis with nasal polyposis (CRSwP) who have failed medical therapy. The goal     of surgery is now to widely marsupialize the sinus cavities in order to optimize topical     steroid irrigation treatment in the postoperative period. With that being said, the true     extent of surgery needed for optimal patient outcome has yet to be elucidated. More     specifically, in the last 30 years, people have argued about the best way to manage the     middle turbinate. Some state that it should be preserved at all times to protect the sinus     cavities from inhaled irritants and allergens and keep this surgical landmark untouched for     future surgeries. On the other hand, there are defenders of routine resection of this     turbinate, whether it is affected by polypoid changes or not. Many studies have looked at the     potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis,     anosmia, or atrophic rhinitis but the more recent literature does not show such significant     associations. A recent topic of debate is whether partial removal of the anterior and     inferior portion of the middle turbinate affects nasal polyps recurrence or improves     long-term outcomes by further facilitation of post-operative topical therapies. Some     retrospective data has shown that its resection could prolong the time before the need for     revision surgery and improve both endoscopic and olfaction scores. A few prospective studies     have also been published but unfortunately none of these were randomized, thus introducing a     significant selection bias. Thus, there is a need for a formal randomized, controlled trial     to elucidate this question.   "
32844|NCT02855918|"     Suicidal behavior (SB) is a major public health problem in France, with more than 10,000     suicides and 220,000 suicide attempts per year.      According to the commonly accepted model for understanding suicidal behavior, individuals who     carry a suicidal act when subjected to stress factors (environmental stress, depression,     substance ...) are those which have a specific vulnerability.      These vulnerabilities can be considered as clinical parameters (propensity to despair,     aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the     serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...).     Suicidal vulnerability is partly underpinned by genetic factors. The interest of current     researches is to identify biomarkers that will improve the opportunities for early     identification of subject with a risk for SB. Numerous scientific studies, including     post-mortem studies of the brains of suicide completers, have established a link between     dysregulation of the ribonucleic acids editing (RNA) of certain genes, the enzymatic activity     of Adenosine deaminases acting on RNA (ADARS) responsible for this edition and suicidal     behavior. A prospective study is needed to quantify and qualify in the blood of depressed     patients (with or without a history of suicide) and healthy controls, the editing changes and     the expression and alteration of the activity of ADARS.   "
32845|NCT02855905|"     A cold season involves higher cardiovascular morbidity and mortality. Several epidemiologic     studies have implicated that persons with a cardiac disease, such as coronary artery disease     (CAD) may be at higher risk for these adverse health events, but the mechanisms are not well     established. Because both exercise and cold exposure stimulates cardiac and circulatory     functions it is important to study their interaction especially among people with CAD and     whose myocardial oxygen supply and function are weakened. The study examines how recommended     health-enhancing upper and lower body exercise and warm-up in combination with cold exposure     affects cardiovascular functions of people with CAD.      The research includes randomized controlled experiments where the participants are 35-75 year     old men with CAD (CCS I-II) and recruited from the Oulu University Hospital. Each participant     undergoes four different trials in random order where the temperature (+22°C or -15°C) and     the form of exercise (brisk walking at 5.5 km/h or upper body exercise at 30 W), and warm-up     regime is varied. The used exercise, clothing and exposure resemble an ordinary wintertime     exercise event. Novel techniques are used to broadly assess cardiovascular function before,     during and in the recovery phase.      The obtained information is synthesized and translated to tailored year-round exercise     instructions for people with CAD by the research team including experts from sports sciences,     physiology, public and occupational health, clinical sciences and with complementary     knowledge in physical activity, effective interventions and cardiovascular function. The     study has broad national and international impact on the relatively passive aging population     having CAD and residing and working in a cold climate. The produced information enables     finding means to activate persons with CAD and where appropriate and safe year-round exercise     may reduce or prevent adverse health effects. Health care personnel will have an improved     possibility to prescribe physical activity programs for their clients and enabling better     instructions of healthy and safe exercise as a way to promote health.   "
32846|NCT02855892|"     This clinical trial is designed as a randomized, placebo-controlled, single-blind, parallel     design, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of GV1001 in     patients with benign prostatic hyperplasia. Eligible subjects are randomized into a group out     of the three study groups and a placebo group after four weeks of placebo run-in period.     Placebo run-in period is concurrently proceeded as a wash-out period for previous treatment     of benign prostatic hyperplasia, and a placebo is administered intradermally twice with     two-week interval during this period. After that, the randomized subjects receive a study     drug and a placebo intradermally seven times with two-week interval by visiting at Week 0, 2,     4, 6, 8, 10, and 12. After the treatment period, the subjects additionally visit at Week 13     and 16, and the efficacy is evaluated at Week 4, 8, 12, 13, and 16, and the safety is     evaluated over the 16-week period.   "
32847|NCT02855879|"     The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose     metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients     about to undergo coronary artery bypass grafting (CABG).      In addition, the effect of these anomalies on post CABG morbi/mortality in the short term     will be evaluated.   "
32848|NCT02855866|"     The scientific interest of this study is to improve post-operative comfort in patients after     thyroid surgery using simple, inexpensive techniques. The investigator expects that local     applications of ice or cortisone aerosols will reduce swallowing discomfort and control     post-operative pain (POP). The investigator hopes that local cryotherapy will decrease     post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the     serous fluid at the site of the thyroidectomy).   "
32858|NCT02855736|"     Suicide is a major health concern. Weeks following psychiatric admission are a highly suicide     risk period for those having current suicidal ideation or attempt. Recently, a pilot study     suggested the feasibility of positive psychology in patients in suicidal crisis. Notably,     gratitude exercises suggested improvement in optimism and hopelessness, two dimensions     associated to suicide. Moreover, gratitude has been associated to suicidal ideation and     attempt, independently from depression. Thus, investigators want to conduct the first     randomized controlled study in order to assess effectiveness of gratitude exercises (vs     control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal     ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.   "
32850|NCT02855840|"     Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)     are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for     100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and     require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on     the everyday life of patients are heavy, and notably linked to skin involvement, to     diminished functional capacities and psychological problems. The vast majority of these     diseases concern middle-aged, professionally-active individuals, for whom the     socio-professional repercussions are major and too often neglected. The aim of this study is     to analyse the consequences of auto-immune diseases on quality of life. Current quality of     life questionnaires are not suitable, and do not reveal the reality of the situation and its     different nuances. In this research, the quality of life of patients will be envisaged     through their everyday lives. How do these patients construct the social reality of the     disease? How do they perceive their health status and their social situation? How do they     organize their everyday lives around the disease: work, leisure, relationships with their     entourage... ?   "
32851|NCT02855827|"     Ovarian cryopreservation is one of the available option for preserving fertility prior to     potentially sterilizing treatments. In the absence of other techniques such as in vitro     folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used     by autograft. In France, the first live birth after orthotopic ovarian transplantation, was     obtained by Roux et al. in 2009.      This clinical trial aims to build a cohort of patients likely to use their ovarian tissue     cryopreserved by autograft.   "
32852|NCT02855814|"     The American Academy of Pediatrics has recommended that growth in size (weight, length, and     head circumference) and in body composition (fat and lean mass) in preterm infants should     adhere as close as possible to the growth and body composition of a healthy infant in utero     at the same gestational age. However, there are no body composition reference curves     available at this time for the preterm infant population. The purpose of this study is to     collect cross-sectional body composition data using air displacement plethysmography (PEA POD     Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants     within 3 days of birth, for the purpose of generating means, standard deviations, and     percentile values for total body fat mass, total fat free mass, and percent body fat for     infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth     retardation will be selected for form the reference sample. The goal is to generate a set of     common reference curves to be used in clinical centers against which to compare body     composition status for individual infants.   "
32853|NCT02855801|"     The main objective of this project is to study, in patients with rheumatoid arthritis, the     effects of an intermittent type exercise associated with cryotherapy on the level of     inflammation during its recovery.   "
32854|NCT02855788|"     phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin,     Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer   "
32855|NCT02855775|"     This Study evaluates covariables being able to potentially influence the elimination of the     monoclonal antibodies (trastuzumab, bevacizumab and denosumab).   "
32856|NCT02855762|"     The objective of this study is to determine how specific dietary control alters the     microbiome composition to effect clinical outcome measures in a longitudinal study of     individuals with bipolar disorder. Our central hypothesis is that a low carbohydrate (CHO) /     high polyunsaturated fat (PUFA) diet will increase the fractional representation of specific     butyrate producing members of the Firmicutes phylum in the gut microbiome, which will     attenuate host inflammation, improve sleep quality and reduce anxiety in bipolar patients.     The rationale for the proposed research is to take the first step in a continuum of studies     to develop personalized novel approaches to treat mood disorders, including the need to     address gut dysbiosis, which often co-occurs with mental illness. The investigators will test     our hypothesis and achieve the objective of this proposal with the following Specific Aims:     1) Determine the taxonomical change in the stool microbiome following a low CHO / high PUFA     diet; and 2) Determine the changes in sleep quality, anxiety, and depression following a low     CHO / high PUFA diet. These aims will be achieved using the unique resources at the     University of Michigan, including the Nutrition Assessment Laboratory for dietary     intervention, the Host-Microbiome Laboratory for microbial assays, and the ongoing Prechter     Longitudinal Study of Bipolar Disorder. At the end of the proposed studies the investigators     expect to set the stage for future studies to assess neurochemical mechanisms. These data     will provide a greater understanding of the mechanism by which diet controls the specific     microbes in the gut microbiome to affect mood disorders and gut dysbiosis and improve     response to psychiatric treatment paradigms.   "
32857|NCT02855749|"     Use of the ultrasound before, during and after percutaneous tracheostomy allows us great     advantages; anatomy of the pre and paratracheal region and displaying potential aberrant     vessels, and so the needle and dilator to move away from risk areas and ensure the prevention     of possible vascular complications. Measuring the distance from the skin into the trachea can     be done and this allows us to choose the average size tracheostomy tube.      The aim of this study, In the process of applying percutaneous tracheostomy, to compare the     reliability of the traditional landmark method, ultrasound-guided long axis in plane     application and ultrasound-guided short axis out of plane application.   "
32897|NCT02855151|"     The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the     management of gastrointestinal disease. The registry will evaluate efficacy, safety and     technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective     registry study.   "
32877|NCT02855489|"     This study has three primary goals. First, to design distinct interventions that target the     three core constructs of the Theory of Planned Behavior (i.e, attitudes, norms, and perceived     behavioral control (PBC)). The second goal is to determine which combination of the Theory of     Planned Behavior constructs is more successful at changing condom use behavior among college     students. Finally, the investigators will examine the impact change in targeted constructs     has on those not targeted by an intervention. The current study intends to empirically test     how the constructs (i.e., attitudes, norms, PBC) in the Theory of Planned Behavior influence     each other to increase condom use with college students.   "
32859|NCT02855723|"     Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated     surgically with systematic lymph node dissection while in 70%, there is no lymph node     metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors     because the status of the sentinel node is predictive of the other nodes status in the neck.     This helps to diagnose the presence of metastases without lymph node dissection and thus     select patients requiring a treatment node. However, the oncological and functional results     of a therapeutic strategy based on identifying the GS is unknown.      This open-label randomized multicenter clinical trial aims to compare the oncologic and     functional outcome of two strategies : the current management versus the management based on     the sentinel lymph node.      The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding     10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2     years with estimated incremental cost-effectiveness and incremental cost-utility, then a step     with log term modeling.      A reduction in morbidity and treatment costs in the sentinel node arm are expected in this     study.   "
32860|NCT02855710|"     This project aims at assessing the opposite relation, namely the effect of a training of the     general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done     by the means of a serious game. Serious games are more and more used to improve the     compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost     tool for rehabilitation.   "
32861|NCT02855697|"     PARP inhibitors, such as olaparib, significantly improve progression free survival (PFS) in     participants with recurrent, platinum-sensitive high-grade serous/endometrioid ovarian cancer     (HGS/EOC), who harbour a germline mutation in BRCA 1 or 2 genes. Despite some of the most     impressive hazard ratios seen in ovarian oncology, such improvements in PFS have not     translated into improved overall survival (OS) advantage potentially because maintenance poly     ADP ribose polymerase inhibitors (PARPi) are only being administered during a single     remission. Here the investigators will test the feasibility of administering a second course     of olaparib in participants who have recurrent platinum-sensitive HGS/EOC.   "
32863|NCT02855671|"     The application of infrared thermal imaging in the diagnosis and prognostication of septic     illness in adults.      During times of severe infection (sepsis), the small blood vessels supplying oxygen and     nutrients to the skin and other organs (called the microcirculation), become abnormal and do     not function as they normally would in health. Monitoring these small blood vessels is     difficult to do clinically and the investigators want to investigate a new way of doing this.      The aim of this study is to validate a novel method of assessing the function of the     microcirculation in healthy volunteers and patients with sepsis, by measuring the skin     temperature profile of the leg and face with a thermal imaging camera. Thermal imaging     cameras measure the heat given off by all objects and represents this as a picture, with     colour used to represent the different temperatures.      Patients will be recruited from the Emergency Department and Intensive Care Units at     University Hospitals of Leicester in to one of two groups based on their illness severity;     uncomplicated sepsis and severe sepsis. Healthy volunteers will be recruited in to a third     group. Recruitment will take place over a 6-month period with follow-up lasting for 12-months     following recruitment. 105 participants will be recruited in total.      Temperature patterns seen on the face and leg will be investigated between the different     groups. Changes in these temperature patterns as patients recover from sepsis (or indeed     become worse), will also be investigated. Information from the thermal images will be     correlated to routinely measured markers of infection, including clinical measurements (blood     pressure, pulse, etc) and routine blood investigations.   "
32864|NCT02855658|"     To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome     under Chinese herbal medicine (SS-1) treatment.   "
32865|NCT02855645|"     Diabetes mellitus (DM) locates fifth of ten leading death etiology, the population of     diabetic patients has a tendency of increase. Trichosanthes root is called as Tian Hua Fen,     According to traditional Chinese writing record that Trichosanthes root has the action of     downbear fire, moisten dryness, and slippery phlegm, and release thirst. The Trichosanthes     root may lower blood sugar levels in the modern study. The investigators designed a double     blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar     were divided into treatment and control groups, and each group was 30 patients. In the     treatment group, oral administration of Trichosanthes root 1.5 g, bid/day for 84 days     continuously; in the control group, oral administration of Trichosanthes root placebo 1.5 g,     bid/day for 84 days continuously. The main outcome measure was the changes of plasma blood     sugar and Glycated hemoglobin A1c (HbA1c) levels changed before and after Trichosanthes root     treatment. The investigators predict the results of the present study indicated that     Trichosanthes root can improve plasma blood sugar and glycated hemoglobin A1c levels.   "
32866|NCT02855632|"     The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating     Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after     hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.   "
32974|NCT02854150|"     The main objective is to improve genetic counseling in patients with Spina Bifida, by the     characterization of variants in new genes using high throughput sequencing either on a panel     of targeted genes or on exome in families.   "
32975|NCT02854137|"     Evaluation of the human eye irritation potential of a test sunscreen formulation.   "
32878|NCT02855476|"     HDClarity will seek to enroll approximately 600 research participants - 500 of whom will be     at different stages of Huntington's disease (HD) and 100 healthy controls. The primary     objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways     that will enable the development of novel treatments for HD. The secondary objective is to     generate a high quality plasma sample collection matching the CSF collections, which will     also be used to evaluate biomarkers and pathways of relevance to HD research and development.   "
32967|NCT02854241|"     The purpose of this study is to investigate clinical feasibility of annual non-contrast     magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group,     in comparison with biannual ultrasonography.   "
32968|NCT02854228|"     The purpose of this study is to observe predictors of pituitary tumor recurrence and markers     of persistent disease activity through computerized collection of comprehensive demographic,     therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions     of all types.   "
32867|NCT02855619|"     Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from     mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning     in intensive care have been performed, with inconsistent results, utilizing different methods     of IMT in different populations.      In this study, the investigators want to compare the incidence of 3 inspiratory muscle     training programs on inspiratory strength, on difficult to wean patients in intensive care     unit.      This is a multi-center randomized trial not blinded with 3 parallels groups:        -  Martin's group: a threshold-based IMT is performed like used by Martin in a randomized          trial in 2011, in a view of inspiratory strength increase.        -  Cader's group: a threshold-based IMT is performed like used by Cader in a randomized          trial in 2010 , in a view of inspiratory endurance increase.        -  EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory          strength and endurance increase.      The investigators think that a new threshold-based IMT performed in a view of both     inspiratory strength and endurance increase, is more effective and well tolerated than the 2     others protocols.   "
32868|NCT02855606|"     The purpose of this study is to determine the factors associated with acceptability to oral     HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and     transgender women (TGW).   "
32869|NCT02855593|"     The proposed qualitative inquiry seeks to understand medical acupuncture from both the     physician and the patient perspective. Interviewees will be asked to describe their     experiences from the point of diagnosis or training up until the present day to capture the     nature of their experiences across the treatment trajectory. Sample size for the qualitative     data collection will be based on saturation of themes (thematic findings, e.g., patient talk     is limited by family knowledge or physician-patient communication is limited by time     constraints in the clinical setting), meaning investigators will continue recruitment until     they are no longer hearing new experiences from participants. Saturation will be kept     separate by groups (i.e., saturation of themes must be met within the group of patients     separately from providers). Investigators will conduct preliminary data analysis after each     10 interviews to determine when saturation is reached. Recruitment numbers here are     anticipated maximum numbers needed to reach saturation. Investigators plan to recruit and     sample provider and patient populations in the following way. Investigators will group     physicians by the physician's training so that we are sensitive to the fact that helpful     patient-physician interaction approaches may differ across the patient's lifespan or with     patient or physician experience with acupuncture. Audio recordings from each interview will     be professionally transcribed and analysis will be concurrent with data collection to ensure     reliability and validity of findings. Investigators will review transcripts as data are     collected to identify emergent themes and ensure thematic saturation.   "
32870|NCT02855580|"     The purpose of this study is to examine the feasibility, acceptability, and utility of     pharmacogenomic (PGX) testing (specifically for the cytochrome P450 2D6 and 2C19 genes) prior     to initiating treatment with an antidepressant (AD) among children and adolescents in the     University of Florida Child Psychiatry clinics.   "
32871|NCT02855567|"     This study investigates the role of acupuncture in controlling post-operative pain in     patients who have undergone gynecological surgery.   "
32872|NCT02855554|"     The overall goal of this project is to evaluate the clinical potential of fast quantitative     myocardial tissue characterization using recently emerged Cardiac Magnetic Resonance Imaging     (CMR) techniques to aid the diagnosis, treatment, and follow up of patients with myocardial     diseases, such as ischemic heart disease, cardiomyopathies, and myocarditis.   "
32873|NCT02855541|"     Previous research suggests that prolonged sitting increases risk for cardiometabolic diseases     and the risk factors associated with cardiometabolic diseases. However, no study to date has     examined if a chronic intervention that breaks up prolonged sitting in a real-world     environment results in a reduction in the metabolic risk factors associated with     cardiometabolic diseases. Thus, the objective of this study is to examine the potential     health benefits of breaking up sitting bouts throughout the workday using a small cycling     device (DeskCycle) in office workers involved with jobs that require prolonged bouts of     sitting. The investigators hypothesize that breaking up sitting will be associated with     improvements in cardiometabolic disease risk factors. More specifically, the investigators     hypothesize that breaking up sitting will decrease blood glucose during an oral glucose     tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure,     decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total cholesterol,     and triglycerides.   "
32874|NCT02855528|"     The aim of this study is to prospectively investigate the diagnostic performance and     potential radiation dose reduction in coronary artery calcium scoring using the new tin     filter system of the 3rd generation DSCT scanner.   "
32875|NCT02855515|"     The main diagnostic challenge in patients with OSA (obstructive sleep apnea) is to determine     the location of obstruction of the upper airway during sleep. This is so, because the     otorhinolaryngology examination, which states probable site of obstruction of upper airways,     is performed in the awake status. Therefore, drug-induced sleep endoscopy (DISE) has been     introduced in the diagnostic algorithm of OSA patients during the last decade. The advantage     of DISE is, that the collapse of upper airways, which is not visible during the awake status     can be observed and targeted therapy according to the location and degree of obstruction of     the upper airway can be applied. As a result, higher treatment success in patients with OSA     can be reached.   "
32876|NCT02855502|"     tracheal stenosis is the result of abnormal wound-healing processes leading to hypertrophic     scar formation and obstruction of the airway lumen by excess granulation tissue. This process     is progressive so treatment and prevention is essential. Resection-anastomosis of the trachea     is becoming the standard of care in many centers and gives the most consistent results in     both adult and pediatric patients. But recurrence stenosis, re-granulation and     re-inflammation are probable. This study aimed to assess the efficacy of systemic     prednisolone on prevention of recurrent tracheal stenosis after surgery.   "
32976|NCT02854124|"     The objective of this project is to evaluate the presence of melanoma quiescent or initiating     clonal cells in peritumoral healthy tissue displaying the same molecular signature than those     of the tumor/metastasis and to correlate this presence to the prognostic value.   "
32879|NCT02855463|"     The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the     Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating information     about the definition and evolution of viruses. Its genome encodes about 1,000 proteins. Three     other viruses were then isolated from amoebas in this unit:Two other giant viruses, Mamavirus     Marseillevirus then, and the first virus a virus, named virophage, which led to highlight the     role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and compounds of bacterial     origin or cellular proteins This project focuses on the detection and analysis of new viral     agents (viruses and virophages giant amoeba environmental) and their involvement in human     pathology.      The objectives of this study are observational: detect and document the presence of giant     viruses and virophages of amoebae in the faeces of children presenting to the pediatric     emergency reception service of the North Hospital in AP -HM with or without clinical evidence     of gastroenteritis.   "
32880|NCT02855372|"     It is commonly accepted that the characteristics of the organ donor impact on the future post     transplant. In lung transplantation (LP), the defining characteristics of the ideal donor     includes an age less than 55 years. However, before the pulmonary graft shortage with a     corresponding mortality still too high waiting list, the lung graft acceptance criteria were     reassessed permitting criteria extension ( marginal graft). And were grafted, depending     on the urgency and accessibility problems in the registry of potential candidate, organs from     donors aged 55 and older with quite comparable to those obtained from younger donors .     Nevertheless, it is common practice that the grafts from older donors are more readily     allocated to older candidates and the most severe, as many confounding factors to assess the     real impact of donor age on post-transplant evolution on small cohorts.      The main goal of this study is to compare the survival of lung transplant patients depending     on the age difference between donor and recipient.      The study will be conducted from a broad national cohort of lung transplant patients     registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by     the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on     French territory. It provides a standardized common longitudinal monitoring of the recipient     from his transplant. Currently more than 1,000 patients included in this study are     transplanted.   "
32881|NCT02855359|"     This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination     with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse     large B-cell lymphoma or follicular lymphoma Grade 3b.   "
32883|NCT02855333|"     The purpose of this study is to analyse retrospectively the early postoperative and     functional outcome of patients (pts) after Merendino procedure for benign or early malignant     lesions of the distal part of the esophagus or the gastroesophageal junction.   "
32884|NCT02855320|"     Background : Inflammatory arthritis (rheumatoid arthritis (RA) or spondyloarthritis (SpA) are     painful chronic diseases which impair quality of life and work capacity. Biologics are very     effective and widely used therapies. However, they are known to entail risks, particularly of     infections. The risk of severe infections is of 5%/patient-year with a maximum during the     first six month after the initiation of the first biologic therapy.      Patient education (PE) is recommended for the management of chronic diseases. In the case of     biologics, PE aims to help patients to learn specific skills particularly on safety issues,     e.g stopping the biologic treatment in case of fever or surgery. Safety skills are assessed     by the validated BIOSECURE questionnaire. PE seems efficient for safety skills in a few     non-randomized studies. In 2010 a national cross sectional survey on 677 patients showed that     the risk of incorrect answers in the BIOSECURE questionnaire was 4 times lower among patients     who had benefited from an education by a nurse or other kind of educational process (OR =3,8     IC95% :[1,68-8,8].      Aims and Hypothesis: this trial aims to investigate the effects of a nurse-led     self-management education face to face intervention on safety skills of patients with     arthritis treated par sub cutaneous biologics. Our hypothesis is that the intervention group     will report better skills at the 6 months follow up compared to usual care i.e information by     the rheumatologist in current consultation.      Methods : multicentric randomized controlled open trial with blinded assessment of the     primary outcome. The intervention group will have a nurse education consultation at M 0 and     M3 in addition to the usual care by the rheumatologist. The nurse will assess the patients'     health beliefs and educational needs, focusing on safety skills, self-injections and     motivation. The control group will have usual care by the rheumatologist.   "
32885|NCT02855307|"     Regular physical activity is associated with many health benefits for individuals with type 1     diabetes including improved cardiovascular fitness and vascular health, decreased insulin     requirements, improved body composition and quality of life. However, exercise-induced     hypoglycemia is very frequent and thus is the main limiting factor for physical activity     practice in this population.      The artificial pancreas is composed of three components: glucose sensor to read glucose     levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the     required insulin dosages based on the sensor's readings. The artificial pancreas has the     potential to reduce the risk of exercise-induced hypoglycemia but the importance of     announcing exercise to the artificial pancreas is yet to be explored.      The objective of this study is to investigate 1) if announcing postprandial exercise to the     artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin     bolus reduction is necessary when announcing the exercise to the artificial pancreas.   "
33193|NCT02851303|"     This study investigates the use of methadone versus morphine wean for the treatment of     neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who     require pharmacotherapy for NAS will receive a methadone wean, and half will receive a     morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be     studied.   "
32898|NCT02855138|"     The investigators consider that there are some rising concerns about the use of isotretinoin     by women of reproductive age with depleted ovarian reserve, hence it is important to detect     the effect of isotretinoin on ovarian reserve.      There has not been a well-designed study evaluating its effects on the human ovarian reserve,     hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS). For this     reasons, this study was administered to determine whether there is an effect of isotretinoin     on the gonads and hirsutism in women with acne and PCOS.   "
32899|NCT02855125|"     This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with     S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in     patients with advanced or metastatic NSCLC.      The study will be conducted internationally in 2 regions: Asian [Japan] and Western [Europe     and US]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1     ratio.   "
32969|NCT02854215|"     The purpose of this study is to investigate the medico-economic impact of adherence to INCa     (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in     cost per Quality Adjusted Life Years (QALY).   "
32886|NCT02855294|"     1. Recording Data Sheet:           All data and information of each woman in both groups (A & B) participated in this study          were recorded in a recording data sheet (Appendix II).        2. Weight-Height scale:           A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight,          and 1 to 200 centimeters height was used to measure the relevant subject's data.        3. Siemens Immulite Immunoassay System:           (Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A)          to measure the serum Progesterone and Estradiol levels in both groups (A& B) using (TKE          21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone.        4. Biodex balance system:      Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to     measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows     approximately 20 degree inclination in 360 degree range and is interfaced with computer     software. It measures the patient's ability to control the platform's angle of tilt, which is     quantified as a variance from the center, as well as the degree of deflection over time at     various stability levels as shown in (Fig. 6).      Stability levels allowed by the system ranged from one to eight. Stability level 8, allows     the highest level of stability as it makes the platform to be the least tilted. On the other     hand, stability level one represents the least level of stability and is more difficult for     the subject to maintain stability on.      The test consists of recording the patient's ability to control the platform variance from a     perfectly balanced position. A large variance is indicative of poor control and balance.     Further definition is realized with the quantification of Anterior/ Posterior and     Medial/Lateral responses.   "
32887|NCT02855281|"     This is a prospective diagnostic pilot study to create hypotheses regarding     immunocytochemistry (ICC) PD-L1 analysis of pleural effusions in NSCLC patients as compared     to the reference standard of PD-L1 immunohistochemistry (IHC). This comparison will be done     to assess sensitivity and specificity of PD-L1 detection by ICC in pleural effusions.   "
32888|NCT02855268|"     This will be a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study     conducted in subjects with Alport syndrome at multiple investigative centers.   "
32889|NCT02855255|"     The proposed study will compare the efficacy of two psychological stop smoking interventions.   "
32890|NCT02855242|"     The human gut microbiota has become the subject of extensive research in recent years,     particularly in regards to the role it plays in obesity. Although lifestyle factors, diet,     and lack of exercise contribute largely to this obesity epidemic, there is increasing     evidence that the human gut microbiota also influences weight gain.      The investigators hope to learn more information about the change in gut microbiota,     especially with regards to those who are successful with weight loss, versus those who don't     lose weight, after participating in a lifestyle modification program at the Dan Abraham     Healthy Living Center (DAHLC).   "
32891|NCT02855229|"     The overarching goal of this multi-disciplinary research program is to develop and optimize     new cross-species translational assessments of reward and cognition that will not only be     assessed in parallel in humans and rats, but also produce neurophysiological and behavioral     metrics that can be objectively compared across species. The research will build on prior     studies by further developing and optimizing (in Phase 1), then validating via     pharmacological challenge (in Phase 2), the following assays in both humans and rats:        1. advanced neurophysiological and computational modeling techniques to record and analyze          EEG activity within and across species; and        2. behavioral assessments of reward learning, cognitive control, and cognitive flexibility          will be analyzed within and across species.      The second phase of the study will test the translational validity of these assays, by     assessing the impact of a targeted drug on task performance and EEG activity in both species.   "
32892|NCT02855216|"     The cervical spine should work as a functional unit. If hypomobility should exist in any of     the segments it would limit the mobility of the spine as a whole. Although it is frequent     that certain cervical segments present hypomobility, they are not always related to     symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have     not been evaluated.      The objetive of this trials is to assess and compare the effects on cervical mobility, of the     manual technique of sub-occipital inhibition by applying pressure and self-treatment by way     of Occipivot® cushion, in subjects with no cervical symptomatology but with limited mobility     assessed by the flexion-rotation test.   "
32893|NCT02855203|"     This investigator driven study will examine the safety, efficacy and biological effects of     combining pembrolizumab (MK-3475) an antibody targeted against anti-programmed cell death 1     (PD-1), with stereotactic ablative body radiotherapy (SABR) for oligometastatic renal cell     carcinoma (RCC). The investigators hypothesise that the safety profile of this combination     will be clinically acceptable.   "
32894|NCT02855190|"     This is an open-labelled two-arm pilot comparative prospective study. All the subjects will     undergo image assessment in the two stages of exchange arthroplasty surgery. At the first     stage, each enrolled subject will receive both FDG and Ga68 citrate PET/CT scans before the     first operation for periprosthetic Joint Infection (PJI). Thus, the test results of FDG and     Ga68 for each individual can be obtained. After the first operation, the surgery/biopsy proof     can be obtained as the gold standard. The subjects those with PJI negative will complete the     process at the first stage.      And the second stage of this study will be based on the subjects with positive PJI from the     first operation. They will receive both FDG and Ga68 citrate PET/MR scans after antibiotic     bone cement was implanted. The sensitivity/accuracy of the two tracers for PET/MR can be     calculated and compared. This stage is aimed to answer whether PET/MR scan is a feasible     imaging tool to provide diagnostic information of infection control status after the     resection arthroplasty of hip/knee PJIs, especially with the implantation of antibiotic     loaded bone cement.      In the second stage, the investigators shift the imaging modality to PET/MR based on the     following reasons: (1) MRI itself has no radiation burden; (2) MRI provides more accurate     tissue contrast information and therefore better anatomic delineation; and (3) currently     there was no study indicating the existence of ABLC may hamper the interpretation of images.      The study duration is expected to be completed in a period of 3 year. It plans to enroll a     total of 50 subjects with suspicious infection. And the investigators expect the PJI     prevalence will be around 60%, i.e. the anticipated number of subjects of true PJI is around     30. The sample size and the prevalence is given based on the clinical availability and     consideration.   "
32895|NCT02855177|"     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2     weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.   "
32896|NCT02855164|"     The purpose of the study is to assess the effects of different doses of LJN452 with respect     to safety, tolerability, and on markers of liver inflammation in patients with NASH   "
33219|NCT02850965|"     To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in     patients with moderate to severe chronic plaque psoriasis.   "
32900|NCT02855112|"     Spinal Muscular Atrophy (SMA) is an autosomal recessive disease of motor neurons. In the     early 1980s, Werdnig from Vienna University and Hoffman from Heidelberg University described     this disorder. So SMA type 1 was named Werdnig- Hoffman disease. This is the first genetic     disorder that cause death after cystic fibrosis in infants with the prevalence of 1 in 6000     birth. Mutation in the SMN1 gene (Survival Motor Neuron) is the reason for the disease that     cause decrease in the SMN protein production. So the alpha motor neurons in the spinal cord     ventricle horn will be destroyed and it cause progressive paralysis and defenite death.No     specific therapy is yet available for the treatment of Werdnig-Hoffmann disease. Treatment is     not disease-modifying and just is supportive. SMA type 1 is diagnosed within the early 6     month after birth and accompanied with breath disorders and definite death in 2 years. The     affected infants have a weak muscle tone and they couldn't even hold their head up. Perhaps     the only open way for these patients is the application of stem cells that could deliver     trophic factor to the apoptotic cells. So this study focuses on the effectivness of cell     therapy via adipose derived mesenchymal stem cells on the probable phenotypic changes in     these patients.   "
32901|NCT02855099|"     Many patients we encounter a month post TAVI, still complain of having symptoms limiting     their daily activity. The investigators set out to study whether rehabilitation strategy     early after the procedure contributes to reduction of the physical disability these patients     suffer from.      Cardiac rehabilitation (CR) is a well-established treatment in patients who underwent cardiac     surgery. Patients after TAVI, are natural candidates for referral to exercise-based CR.     Despite this, until 2013 no data have been available about the safety and the efficacy of a     comprehensive rehabilitative period in these subjects. CR is a helpful tool to maintain     independency for daily life activities and participation in socio-cultural life. despite     these differences, both patient groups did benefit in the same way from a post-acute     in-patient rehabilitation program as assessed by 6-Minute Walking Tests and FIM scores.     Patients who were unable to walk and those were slow walkers at baseline experienced an     improvement in functional status after TAVI, whereas the fast walkers did not improve and     actually experienced a modest decrease in 6MWTD.It has been shown that patients referred for     rehabilitation after TAVI are often very frail, with a high grade of functional impairment,     dependence on others and high risk of clinical complications. During a rehabilitation     program, based on a multidimensional assessment and intervention, most patients showed     significant improvement in functional status, quality of life, and autonomy, which remained     stable in the majority of subjects during mid-term follow-up.      To the investigators knowledge, no prospective study compared rehabilitation strategy to     conservative treatment after TAVI. the investigators set off to test the investigators     hypothesize that CR may help in the short and long term prognosis of these patients.   "
32902|NCT02855086|"     This pilot phase I/II trial studies the best dose of cetuximab-IRDye 800CW and how well it     works in detecting tumors in patients with malignant glioma who are undergoing surgery.     Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a     special camera is used.   "
32903|NCT02855073|"     The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee     Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.   "
32904|NCT02855060|"     The purpose of this study is to determine whether the use of pelvic binders in the ambulance     setting improves outcomes including mortality in patients with pelvic fractures.   "
32905|NCT02855047|"     The primary objective of this study is to evaluate plasmatic concentrations of free PGF and     sFlt1 for blood samples taken before a first low-molecular-weight-heparin injection and also     for blood samples taken on the 4th day of injections (the latter correspond to the first     systematic control of platelet counts) in women who have an obstetric antiphospholipid     antibody syndrome and who are initiating a new pregnancy with recommended treatment. Our goal     is to test the prognostic value of these data on the occurrence of:        -  pregnancy loss categorized as embryonic loss (before 10 weeks gestation), fetal death          (before 20 weeks gestation), stillbirths (from 20 weeks gestation to delivery), and          neonatal death defined before reaching 28 days of age.        -  ischemic placental pathology (pre-eclampsia, retro-placental hematoma, birth of a          small-for-gestational-age infant)   "
32906|NCT02855034|"     Head injury is a frequent motive of consultation in paediatric emergency units and the first     cause of mortality in infants of more than one year old in developped countries. The     indication of performing cerebral CT scans currently depends on clinical decision based on     recommendations used in adults. In this way, 60 to 90% of scans are normal in children with     head injury. CT scan is expesive and irradiating with the risk of increasing the cancer in     children. Protein S 100B and copeptine are biomarkers which have shown their ability to     detect cerebral lesion in children with head injury. (protein S 100B and /or in adults     (protein S 100B and copetine.      It is the first clinical biological evaluation of severity of head injury based on dosing of     copeptine alone or associated with proein S 100B.   "
32907|NCT02855021|"     Parkinson's disease (PD) is a common disease. Dementia will affect 80% of these patients     during their evolution. In addition, treatments of motor signs have a potential impact on     these disorders and conversely.      The purpose of this study is to show focal abnormalities in brain metabolism in the precuneus     and posterior cingulate region are predictive of the onset of dementia within 2 years.   "
32908|NCT02855008|"     Aggressive/challenging behaviors in individuals with intellectual disability are a major     public health concern for them, their families, their service programs and staff, and their     communities. This randomized clinical trial will test the efficacy and cost effectiveness of     a preventive community-based social problem solving intervention, the Steps to Effective     Problem-solving (STEPS), delivered in group homes. The program uses residential staff     participation and the group environment to facilitate improved social problem solving skills     and reduce aggressive/challenging behaviors in this population in group homes and work     settings.   "
32935|NCT02854657|"     The proposed study is a continuation of a research program (STU00017005: Interventions to     teach melanoma patients skin self-examination) designed to increase early detection of     melanomas before they metastasize. In 2015, approximately 73,870 individuals in the U.S. will     be diagnosed with invasive melanoma and about 9,940 will die from the disease. During     2002-2011, melanoma incidence increased at an average annual rate of 1.6% for men and 1.5%     for women. People with a history of melanoma have 10 times greater risk of developing a     second primary melanoma relative to the general population.Early detection with surgical     excision at an earlier stage when treatment is usually more effective is the only proven     curative strategy.   "
32936|NCT02854644|"     This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral     antigens breast cancer and glioma.   "
32970|NCT02854202|"     The investigators hypothesis is that eating whey protein in breakfast will reduce overall     postprandial glycemia in individuals with type 2 diabetes (T2D).   "
32909|NCT02854995|"     Traditionally, BXO is managed with circumcision (surgical removal of the foreskin) and this     approach has long been held as the 'gold standard. Whilst this may be curative in many cases,     it has been shown that 20% of boys require a further operative procedure on their penis to     widen the urethral opening (to treat meatal stenosis)      An alternative to circumcision was proposed: a preputioplasty (surgery to widen the opening     of the foreskin) was combined with injection of steroids into the affected foreskin.     Subsequently, the same group compared the outcomes of this technique with circumcision, and     reported circumcision was successfully avoided in 92% of the preputioplasty group. In     addition, the rate of meatal stenosis (narrowing of the urethral opening requiring surgery)     was significantly lower (6% vs 19%, P = .034 ). Preputioplasty may therefore: (i) offer     protection against meatal stenosis and reduce the requirement for further surgery; and (ii)     offer the benefit of retaining the foreskin, the function of which, while debated, likely     includes sexual function. In view of these potential benefits, authors have called for a     randomised trial to compare circumcision to preputioplasty and injection of steroids.   "
32910|NCT02854982|"     To study the quality of life of patients with prostate cancer at a distance from their care     at a time when they are supposed to have taken a normal life and compared to subjects     without cancer prostate of the same age.   "
32911|NCT02854969|"     Through several questionaries the investigators will measure the satisfaction of patients     diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a     smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.   "
32912|NCT02854956|"     X-linked Mental retardation (XLMR) represent 10% of the causes of mental retardation with a     prevalence in both sexes around 1/296, i.e. 3.3 / 1000 births (Opitz et al., 1986). This     heterogeneous group of XLMR includes dozens of rare diseases, some of them affecting only a     few patients. Molecular diagnosis is currently available in France for 25 XLMR genes, within     the national network of XLMR molecular diagnosis. However, whereas some syndromes such as     Fragile X syndrome, are now well clinically defined, this is not the case for recently     identified syndromes for which very few data is available, preventing clinicians to focus     molecular diagnosis on a specific gene.      Therefore, this study aims to :        -  Achieve a description of the clinical phenotype specific to each XLMR gene (Phase 1 of          the study, n=200)        -  Characterize the cognitive learning mechanisms and dysfunctional neural networks          involved (Phase 2 of the study, n=75, i.e. 5 groups of 15 patients with a mutation in          the same gene). These two elements constitute key steps to develop appropriate          rehabilitation strategies and targeted pharmacological therapies.      Moreover, the impact of mental retardation on the primary caregiver within the family and the     induced burden in terms of psycho-social, organizational and economic burden will also be     assessed. These elements, directly related to the patient's environment, are very important     to characterize in order to better understand the consequences of each gene mutation (Phase 3     of the study, n=283). For example, it is necessary to better understand the impact of Fragile     X syndrome in terms of capacity and behavior, lifestyle, and health care needs of the     patients While advancing knowledge allows to consider innovative therapeutics, the     implementation of these therapeutics and assessment of their impact on the patients' life     trajectory, require precise characterization of the population to be treated in medico     socioeconomic terms.   "
32913|NCT02854943|"     Retrospective analysis of ferritin, outcome and HLH-criteria in critically ill patients.   "
32914|NCT02854930|"     Migraine is a common disabling primary headache disorder. Epidemiological studies have     documented its high prevalence and high socio-economic and personal impacts. Migraine affects     more than 20% of the French population. However, the physiopathology of migraine is always     partially known. Cortical spreading depression (CSD) is the widely accepted as the     electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient     neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known     phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening     conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep     intrusion have been discussed. However, the role of DCE has never been discussed. The goals     of this study are : to see if there is an epidemiological link between NDE and migraine/ to     specify if NDE was followed by a migrainous headache.   "
32915|NCT02854917|"     This study is a retrospective review of the data collected in a previously completed     randomized, controlled trial (RCT) entitled Memantine and Comprehensive, Individualized,     Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial     (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's Disease     (AD) were randomly placed into one of two groups: memantine, or memantine plus an     individualized management program consisting of home visits, educational sessions for     caregivers, and a caregiver support group. Participants received the study intervention for     28 weeks; study follow-up lasted for 52 weeks.      The collected data from the existing study books from the 28 week treatment portion of the     RCT will be carefully examined with respect to each of the research questions for the present     retrospective study.   "
32916|NCT02854904|"     Alpha-agonist in anesthesia display immunomodulatory effect in addition to antiadrenergic     control. This effect of the immune system can be a key to a better perioperative safety and     quality.      The association of dexmedetomidine at general anesthesia adds up organic protection and     inflammatory control to a surgery trauma owing to antinociception and immunomodulatory     effect.      The aim this study is evaluate if the association of dexmedetomidine at general anesthesia     standing effective immunomodulatory control to trauma and improve changes at outcomes in     patients undergoing to spinal fusion.   "
32917|NCT02854891|"     Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained     elongation of the eye globe There are number of theories concerning the environmental effect     on the emmetropization process, most are related to childhood exposure to outdoor activity,     near work and sleep with night light. Studies in lab animals found an association between     intensity of ambient lighting and myopia development.      In this study, the investigators will examine the ambient light in kindergarten and schools     and their relation to refractive error. Diurnal luminance in kindergarten and school class     room will be measured and correlated to biometric measures such as refraction, axial length     and keratometry.   "
32918|NCT02854878|"     A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing     head lice and their eggs.      23 participants will be enrolled in this study. The first 12 will be combed with model A and     the remaining 11 will be combed with model B   "
33220|NCT02850952|"     To determine whether implementation of Rehab MATRIX will improve patient safety, patient     satisfaction and nursing indices.   "
35751|NCT02817828|"     The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding     pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol     (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 18 to 50 years.   "
32919|NCT02854865|"     Determining the LV filling pressure is a key element in the diagnosis and management of     patients with suspected decompensated heart failure. The aim of the present study is to     assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain     (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in     the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in     patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method     based on 2D strain imaging that enables the simultaneous quantification of myocardial strain     in different left ventricular segments; its 3-click method minimizes variability related to a     manual training of endocardial border required in an usual 2D-strain analysis.      AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study     is a prospective observational single-center cohort study. 30 Patients scheduled for elective     cardiac surgery will be included in the study group. The study is designed to assess whether     GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of     LVFP measured as PCWP.   "
32920|NCT02854852|"     Changes in the vascular tone of anesthetized patients is common and cause hemodynamic     problems. The monitoring of such changes in vascular resistance using simple and non-invasive     tools is lacking. The present study was designed to determine if photoplethysmography can     detect changes in the systemic vascular resistance using Doppler as the reference method.   "
32921|NCT02854839|"     The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural     killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial     chemoembolization (TACE).   "
32922|NCT02854826|"     Systems Addressing Frail Elders (SAFE) Care is a nurse-led interprofessional team model to     rapidly identify and provide safe and effective inpatient care to high risk older adults and     help support their successful transition back to the community. Developed and demonstrated to     be effective in one hospital - the model is now being disseminated and studied in three     additional hospitals (multiple organizational case study).   "
32923|NCT02854813|"     Investigators aimed to investigate the association between over active bladder and coronary     artery disease as demonstrated on coronary angiography.   "
32924|NCT02854800|"     The purpose of this study is to examine the effectiveness of a smoking cessation intervention     for cigarette smokers enrolled in an outpatient program for opioid dependence. Treatment     effects will be compared as a function of phase in the outpatient program: 0-90 days, 90     days-1 year, and more than 1 year.   "
32925|NCT02854787|"     The purpose of the study is to determine if an intravenous bolus of phenylephrine is more     effective compared to an intravenous bolus of norepinephrine associated with crystalloid     loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery.     Prevention of low blood pressure has been shown to decrease nausea and vomiting during and     after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all     participants will receive spinal anesthesia with a local anesthetic and sufentanil. This     study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a     computer generated system to be in one of two groups.   "
32926|NCT02854774|"     This is a randomized controlled trial of knee muscle versus hip muscle strengthening for     Patellofemoral Pain Syndrome.   "
32927|NCT02854761|"     This study evaluates the safety and tolerability of the investigational drug EF-022 in the     treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be     administered EF-022, either intramuscular or subcutaneous, for a period of 6 months.     Preliminary effect of the drug on the disease will be evaluated by following the number and     severity of the lesions in the respiratory tract and the effect on voice changes.   "
32928|NCT02854748|"     This study is a randomized, open-label, multiple dosing, crossover study to evaluate the     drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers   "
32929|NCT02854735|"     The purpose of this study is to define the role of total body composition in the guidance of     nutritional support and treatment monitoring in head and neck patients. Furthermore, the     second aim of this study is to compare the clinical performance of dual energy X-ray     absorptiometry as compared to CT in evaluating total body composition of patients.   "
32930|NCT02854722|"     In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for     osteoporosis. Osteoporosis is a common complication in various diseases, such as     hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share     iron accumulation as a common denominator. Moreover, a 3-year retrospective longitudinal     study has shown that iron accumulation was also associated with osteoporosis in healthy     adults and especially that it can increase the risk of fractures in postmenopausal women.     Based on these observations, iron chelation therapy may have a promising future in the     treatment of iron accumulation-related osteoporosis by removing iron from the body.      The purpose of this study is to determine whether the addition of the iron chelator,     deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.   "
32931|NCT02854709|"     This is a randomized cross over study of the effect of 2-week sleep extension in chronically     sleep deprived non-diabetic individuals on glucose metabolism.   "
32932|NCT02854696|"     The main goal is to perform a cost-utility analysis to compare islet cell transplantation     versus best medical treatment (defined as Sensor augmented pump therapy) for patients with     brittle type1 diabetes.   "
32933|NCT02854683|"     We and others have shown that many younger patients with Myalgic Encephalomyelitis/Chronic     Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), i.e., they can't tolerate     prolonged standing. OI in ME/CFS is often accompanied by either postural tachycardia syndrome     (POTS) in which standing results in an excessive heart rate, and neurally mediated     hypotension (NMH) in which standing causes a fall in blood pressure and fainting. Intravenous     fluids can alleviate these symptoms, but is difficult to administer; oral fluids fail to     provide the same benefit. We would therefore like to test the effectiveness of an oral     rehydration solution (ORS, W.H.O. formula) making use of co-transport of glucose and sodium,     to reverse these symptoms in ME/CFS subjects with POTS or NMS, and will compare these results     with healthy control subjects.   "
32934|NCT02854670|"     This study aims to assess the pain on contact in provoked vestibulodynia, measured with     Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.   "
32940|NCT02854592|"     Stroke is one of the leading causes of death and disability in China. Intravenous     thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for     ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in     addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010     Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke,     and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is     used more frequently than rt-PA, mainly because it is cheaper. To describe Chinese experience     with thrombolytic therapy for Ischemic Stroke within 4.5h onset, we designed a multicenter,     prospective, registry study. The aim of INtravenous Thrombolysis REgistry for Chinese     Ischemic Stroke within 4.5 h onset（INTRECIS）was to assess the safety and efficacy of     intravenous rtPA, urokinase as thrombolytic therapy within the first 4.5 h of onset of acute     ischaemic stroke.   "
32941|NCT02854579|"     The purpose of this study is to investigate the efficacy and safety of allogenic neural     progenitor cell and paracrine factors of human mesenchymal stem cells for patients with     moderate/severe Hypoxic-Ischemic Encephalopathy   "
32942|NCT02854566|"     Observational retrospective study on 36 consecutive patients having had surgery for a     periprosthetic fracture of the femur between 2010 and 2015.      The goal of the study is to test whether osteosynthesis was a secure choice at a certain age     and with any type of Vancouver fracture.   "
32943|NCT02854553|"     The transversus abdominis plane (TAP) block is an effective regional nerve block for the     anterior abdominal wall. An anesthesiologist typically administers the TAP block     preoperatively with ultrasound guidance. It is not yet commonly used during anterior     abdominal wall liposuction, where postprocedural pain remains a major concern for patients     and surgeons.   "
32944|NCT02854540|"     This small feasibility study will evaluate the use of hydrogel electrode pads (rather than     tap water baths) to deliver iontophoresis treatment using a traditional iontophoresis device.     Participants will treat one hand with the hydrogel-based iontophoresis device and leave the     other hand untreated.   "
32945|NCT02854527|"     Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin,     furosemide, metformin, and rosuvastatin when given all together as a cocktail   "
32946|NCT02854514|"     For all women immediately after ovum retrieval from 80 women undergoing IVF, intra uterine     salin flushing will be analyzed using a multiplex immunoassay for soluble regulators of     implantation, namely Interleukin (IL)-1b, Tumor Necrosis Factor (TNF)-a,. In order to detect     implantation predictors.   "
32947|NCT02854501|"     The current study included the singleton pregnancies (without history of previous risk     factors), had their homocysteine measured as part of a serum-screening program in addition to     uterine artery Doppler. Sensitivity, specificity, positive and negative predictive values,     for development of preeclampsia and other adverse pregnancy outcomes were assessed as     follows; (1) Homocysteine cutoff level at 6.3 µmol/l; (2) Bilateral notches on Doppler with a     mean RI >0.5, all unilateral notches with a mean RI >0.6, in addition, absence of notches     with a mean RI >0.7; (3) Doppler assessment combined with the homocysteine cutoff (6.3     µmol/l).   "
32948|NCT02854488|"     The study is a global safety surveillance study of pregnancy outcomes in women who were     exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age   "
32949|NCT02854475|"     The purpose of this study is to      I. determine several skin parameters, for example natural moisturizing factor (NMF) and     cholesterol, with Raman spectroscopy in vivo and      II. compare the results with the corresponding cholesterol levels measured in venous blood.   "
32950|NCT02854462|"     The aim of this project is to test whether training parents to ask their children 'inference-     eliciting' questions during book reading is effective in promoting story comprehension for     4-year-olds from a range of socio-economic backgrounds.   "
32951|NCT02854449|"     This study will follow-up different immune cell populations in the blood before, during and     after high dose radiation therapy which should give new information of the efficacy of Local     Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.   "
32952|NCT02854436|"     The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of     niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and     deoxyribonucleic acid (DNA) repair anomalies.   "
32977|NCT02854111|"     The overall global prevalence of type 2 diabetes mellitus (DM) is rising. Based on the latest     Thai National Health Examination Survey, an estimated 3.2 million people had DM, of whom     one-third was undiagnosed. The inexpensive oral glucose tolerance test (OGTT) is a more     sensitive and reliable test of DM than fasting plasma glucose (FPG) or HbA1c, and is     recommended for diagnosing DM and impaired glucose tolerance (IGT). Although the OGTT     provides useful diagnostic information, poor patient tolerance of glucose solutions is     inevitable.   "
35768|NCT02817607|"     The purpose of this study is to establish techniques for evaluating breast cutaneous     sensation at baseline and following either lumpectomy or mastectomy for breast cancer.   "
32953|NCT02854423|"     Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based     everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as     compared with early generation DES. BP-BES with DP-EES have been directly compared in 2     randomized trials, showing no differences between the two devices in all-comer patients     during long-term follow-up. It is unknown whether these results are consistent in real-world     patients with diabetes mellitus during long-term follow-up. To evaluate the safety and     efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared     to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes     mellitus during long-term follow-up.      Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or     DP-EES implantation were included in a multicenter registry between January 2007 and May     2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity     score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse     events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel     revascularization (TVR). Secondary endpoints are the individual components of the primary     endpoint as well as definite stent thrombosis (ST).   "
32954|NCT02854410|"     The purpose of this study is to evaluate whether dietary nitrate supplementation could     improve the salivary flow for nasopharyngeal carcinoma patients receiving concurrent     chemo-radiation therapy.   "
32957|NCT02854371|"     Liver function is a key factor that can help predict the clinical outcome in patients with     cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or     other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in     several studies. There have been several approaches to measure liver function using gadoxetic     acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced     liver MRI is clinically used world widely, it would be valuable if we can measure liver     function using hepatocyte fraction.   "
32958|NCT02854358|"     Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of     the most common side effect of radiation therapy among patients with HNC. Mouth dryness     significantly impairs patients' quality of life (QOL).      HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their     beneficial effects in recent studies, we decided to design a randomized, controlled clinical     trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation     induced xerostomia   "
32959|NCT02854345|"     The goal of this study is to assess the performance of parathyroid imaging on a     cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for     primary hyperparathyroidism.   "
32960|NCT02854332|"     Prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more     than 58 % for patients that carry a lesion of the spinal cord. This pathological condition     stays a major health problem, particularly as the efficacity of available treatments is     currently limited. Only 30 to 40% of patients are relieved of more than 50% of their pain by     a pharmacological approach.      In case of failure, drug treatments or in addition of these ones, stimulation of the motor     cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that     found its place for neuropathic drug-resistant pain management only since a decade.     Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are     still little understood. This stimulation can be realised in a chronic and invasive way with     implanted electrodes. This process allow a lasting relief for about half of operated persons,     without the possibility to identify clinical selection criterion reliable for potentially     responding patients for this technique.      Recently, two electrophysiological non invasive techniques have been developed, allowing to     get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic     stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).      The main goal of this study is to compare the importance of analgesic effect of tDCS in     chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of     stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already     validated by data of the literature.   "
32961|NCT02854319|"     The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the     LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for     transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific     aortic stenosis who are considered high risk for surgical valve replacement.   "
32962|NCT02854306|"     Mindfulness is a common practice already widely used, that has shown benefits in terms of     psychological and physical health. It is about learning or learn again to be self present and     aware to the environment, across breathing, sensations, emotions and thought centering     exercises, in the present moment without any judgement.      The goal is to evaluate the efficacy of mindfulness versus an active control group in     bariatric surgery.   "
32963|NCT02854293|"     Prospective, randomized, multicentre phase III study to evaluate the level and type of     information requested by patients or families during a palliative care consultation after     they have been given the Booklet-Question List (BQL).   "
33013|NCT02853643|"     The purpose of this study is to evaluate the safety and tolerability, and determine the blood     levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002.     Healthy volunteers will be participants in the study.   "
32964|NCT02854280|"     Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF), the     modification of one or the other can affect the neuronal O2 availability.      Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in     state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and     therefore of the CBF, can create an important dizziness between the demand and the supply of     cerebral O2.      It seems that hypoxia can trouble in a significant way the response of central neurons, just     as the production of a motor cortex generated motor command.      Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat     for brain oxygenation and the motor command, with the consequence a decrease of the exercise     performance.      This projects aim to study effects of hypoxia on the brain function for patients suffering     from chronic respiratory disease. Neurophysiologic responses of the brain while resting or     exercising, including drip and cerebral oxygenation, cortical excitation and motor command     resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz     in blood.      The study will use a multidisciplinary and supplementary methodological approach : the     near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF,     neurostimulation procedures and electromyography (EMG) to appreciate the cortical     excitability, measure the level of central activation and motor command.      The goals of this study will be :        -  Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of          voluntary activation and central fatigue to the effort for the chronic hypoxemic patient          compared to healthy control subjects.        -  Analyse disruptions of locomotion parameters and posturographyc, in simple and double          task, involving different levels of cerebral task.        -  Analyse acute effects of an improvement of arterial oxygenation for patients suffering          from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation,          cortical excitability, mechanisms of voluntary activation and central fatigue.        -  Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for          patients suffering from obstructive sleep apnea (OSA) with the same parameters.   "
32965|NCT02854267|"     A dedicated guide for physicians and organ procurement nurses meeting with the next of kin     could be associated with a reduction in organ donation refusal rate, and in anxiety of     professionals involved in such meetings   "
32966|NCT02854254|"     In decompensation of heart failure, it may occur low cardiac output. For patients in this     situation, the use of inotropic may be necessary. Prolonged intravenous infusion of inotropic     agents can lead to phlebitis in peripherally venous access. On the other hand, central venous     access presents complications inherent in the procedure. The peripherally inserted central     catheter (PICC) may be an option in this situation. The present research project is a     randomized clinical trial to evaluate the incidence of phlebitis by using the PICC in     comparison to the peripheral venous access. The criteria for inclusion are: advanced     congestive heart failure, in use of intravenous inotropic; platelets > 50.000 mm3 and left     ventricular ejection fraction (LVEF) < 0.45. Patients will be randomized to receive the PICC     or keep the peripheral venous access. The main outcome will be the occurrence of phlebitis.     The sample size will be of 40 patients for each group (PICC and control). The data will be     analyzed by logistic regression. Will be considered significant P 0.05.   "
32971|NCT02854189|"     The purpose of this study is to explore the effects of the Oxford unicompartmental knee     arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure     and one without. Specifically, this study compare the number of occurrences of postoperative     genu recurvatum and the postoperative hyperextension angles among the patients. Additionally,     the knee scores, the pain scores, and the functional scores for the two groups of patients     are compared.      Materials and methods: This study prospectively followed 104 patients (114 knees) who had     been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and     had had a minimum of 24 months of follow-up. The patients were divided into two groups: those     without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu     recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the     postoperative hyperextension angles, the knee scores, the pain scores, and the functional     scores were recorded and compared between two groups..   "
32972|NCT02854176|"     Worldwide, 9.6% of men and 18% of women aged over 60 years suffer from osteoarthritis (OA),     most of which involve the knee. Within the OA patient population, 80% of the OA patients have     limitations of movement, and 25% cannot perform the majority of their daily activities (WHO).     Some of these symptoms contribute to arthrogenic muscle inhibition (AMI), a reflexive     decrease in motor output to the muscles surrounding the affected joint.      AMI is characterized by abnormal afferent information transmitted to the central nervous     system, resulting in altered afferent feedback to the quadriceps motoneurons (MN) which in     turn results in reduced excitability of that particular pool. The altered afferent input is     suggested to stem from stimulation of mechanoreceptors, via joint effusion or excessive     movements, nociceptors as a response to pain, or loss of joint receptors (Palmieri-Smith et     al., 2009). Although the evidence concerning the role of the central nervous system is     scarce, pre- and postsynaptic spinal mechanisms directly affecting alpha-MNs seem affected.     Dysfunction of γ-loops also seems to be involved (Konishi et al., 2002). These mechanisms     together result in AMI that manifests through aberrations in voluntary quadriceps torque,     force control, and reflex excitability often measured by the H-reflex (Hopkins et al., 2000).      Besides the evident role of motor efferents, sensory afferents also influence motor control     (Gentilucci et al., 1997) and poor proprioceptive function is predictive of poor chair-stand     performance (Sharma et al., 2003). Reduction of the sensory deficits could potentially     increase motor function in knee OA. The present study aims to evaluate whether low-intensity     peripheral electrical nerve stimulation, a form of increasing afferent input, could     potentially improve OA patients' motor function. The most limiting factor in OA patients,     however, is pain, experienced at rest and during movement. Although previous paradigms used     high-frequency stimulation and the lack of physiological explanations concerning pain     reductions after peripheral electrical nerve stimulation, it is possible that reductions in     experienced pain are mediated by reduced analgesia, i.e., decreased excitability of     nociceptive neurons.   "
32973|NCT02854163|"     The investigators propose an open label pragmatic clinical and laboratory study designed to     investigate, in detail, the clinical and molecular effects of Interleukin 17 (IL-17) and     inhibition of IL-17 with secukinumab, on neutrophil function in vitro and ex vivo.      As secondary, exploratory objectives, the investigators will utilise the fact that     secukinumab is to be administering to 20 patients with Psoriatic Arthritis (PsA) and     investigate whether there is any relationship between vitamin D status and response to     secukinumab, with respect to efficacy and adverse events. The results of this secondary     exploratory analysis will inform the design of a larger, definitive study.   "
33025|NCT02853487|"     The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.   "
32978|NCT02854098|"     Benign Hypermobility Joint Syndrome is a group of inherited abnormalities in the structure of     connective tissues, manifested by disturbances in the proportion of collagen. The main     symptoms of this syndrome include: laxity of joint capsules and ligaments, hypermobility of     the joints, as well as numerous disturbances in the functioning of internal organs that     contain connective tissue, including the gastrointestinal tract. Hypermobility of joints     affects approximately 10% of the population of Western countries, is more common in small     children and female. Modified Beighton scale is the basic scale for assessing hypermobility     of joints. The scale (as assessed using the goniometer) is a reliable tool for the evaluation     of excessive laxity of the connective tissue in children.      Functional constipation is a very common condition, affecting approximately 3-5% of children     and adolescents, with peak onset between 2 and 4 years of age. The etiology of this disorder     is multifactorial, and till day it is still exactly unknown why some children develop     constipation, while in others we can observe the correct scheme of defecation. Suspending     stool enhances the retention of fecal masses, which subsequently causes painful defecation.     Diagnosis is based on history, clinical symptoms and physical examination. Increased     susceptibility of the wall of the distal gastrointestinal tract could explain the     predisposition of some children to retain fecal masses and the development of constipation.      Due to the unclear etiology of functional constipation, it seems reasonable to conduct a     study assessing whether excessive laxity of connective tissue (assessed on the basis of the     hypermobility of the joints) facilitates the accumulation of stool in the large intestine,     and so is the one of the reasons leading to development of functional constipation in     children.   "
32979|NCT02854085|"     The objective of this study is to determine the impact of Art Therapy and Music Reminiscence     Activity on cognition in community living elderly with Mild Cognitive Impairment (DSM V: Mild     Neurocognitive Disorder) using a randomized control design.      Specifically, the structural cerebral changes that occur with the two interventions and the     extent to which the therapies may reverse cognitive impairment and/or prevent further     cognitive decline, will be determined.      The hypothesis is that participants in both active intervention arms will perform better on     neuropsychological tests of cognition and will show positive changes on functional imaging     studies compared to controls who will not receive any intervention. Participants in the     interventions will also have positive changes in blood biomarkers, enhanced psychological     well-being and reductions in anxiety and depressive symptoms compared to the control group.     No a priori hypotheses were developed as to whether Art Therapy or Music Reminiscence     Activity is more effective as the comparison is exploratory.   "
32980|NCT02854072|"     To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus     Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.   "
32981|NCT02854059|"     The main purpose of this study is to evaluate safety and tolerability in patients diagnosed     with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single     intravenous dose of IdeS.   "
32982|NCT02854046|"     Calciphylaxis, also called Calcific Uremic Arteriolopathy (CUA) is a lethal affection mostly     affecting patient in end stage renal disease. The survival rate is described around 20 to 46%     at one year.      Clinical presentation is very painful skin lesions with ulceration mostly located on the     trunk or thigh.      Current knowledge about physiopathology, diagnostic practice and therapeutic is very limited.      Actually there is no European study about calciphylaxis and risk factors, diagnostic practice     and outcome factors.   "
32984|NCT02854020|"     Since the number of air travelers, including the elderly and passengers with an underlying     disease, is increasing every year, the number of inflight emergency patients is expected to     increase as well. The investigators attempted to identify the incidence and types of inflight     medical emergencies and analyze the first aid performed by cabin crew members or medical     volunteers in flights by an Asian airline. The investigators also investigated the causes of     inflight deaths and aircraft diversions.   "
32985|NCT02854007|"     A multicenter, prospective, observational cohort study with clinical, quality of life, and     economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients     with ischemic heart disease revascularized with Absorb in standard clinical practice in     Spain. A before-after comparative analysis will be performed, so that each patient will act     as his/her own control.   "
32986|NCT02853994|"     The study is a prospective, non-randomized, multicenter, post-marketing surveillance study     evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding     device approved indications:        -  In-stent restenosis lesions: either bare metal or drug eluting stent restenosis        -  Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in          side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary          arteries        -  Small vessels: treatment of lesions ≤2.75 mm        -  BMS implantation followed by DCB inflation   "
32987|NCT02853981|"     The purpose of this study is to determine whether clamp-crush technique for liver parenchymal     transection is as safe as Harmonic scalpel device. outcomes will include: perioperative     mortality, surgery-related complications, blood loss, amount of blood loss during     hepatectomy, operating time, transection speed, markers of liver parenchymal injury and     hospital stay.   "
32988|NCT02853968|"     The purpose of this study is to study stained Castleman's Disease lymph nodes and perform     flow cytometry and cell culture experiments on Castleman Disease blood samples to determine     which cellular pathways and immune cell types are driving the disease.   "
32989|NCT02853955|"     Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and     effective alternative treatment option for selected patients at high risk for cardiac     surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair     (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this     multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to     evaluate the effectiveness and durability of this minimally invasive treatment option in this     subset of patients.   "
33026|NCT02853474|"     This prospective, randomized, open-label and multicenter phase III study is aimed to estimate     the survival benefit of Early Palliative Care (EPC) combined with standard oncology care     including first-line chemotherapy (experimental arm) over standard oncology care only     (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer,     pancreatic cancer, biliary tract cancers).   "
32990|NCT02853942|"     Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous     adipose stem cell transplantation in the treatment of makes the acceptance micro vascular     decompression hemifacial spasm patients to nerve function to obtain a better recovery.      Secondary purpose ：To clarify the efficacy of stem cells in the treatment of cranial nerve     dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.      Cases in group：Appearing on the surface of microvascular decompression for hemifacial spasm     to decrease neural electrophysiological index of patients research design：Single center,     prospective, randomized, double-blind, controlled Observation index：Facial nerve clinical     score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal     fluid index Evaluation of therapeutic effect：Facial nerve function evaluation     (House-Brackmann classification, facial nerve function classification scale SFGS), facial     nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric     measurement Safety evaluation：Clear evaluation of hemifacial spasm and micro vascular     decompression were listening to nerve in intracranial segment wrapped around the autologous     fat stem cell therapy overall safety and evaluation methods including adverse events,     laboratory tests, vital signs, electrocardiogram.   "
32991|NCT02853929|"     The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa     booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14     weeks. All infants in this booster study were born to pregnant women who participated in the     study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as     per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.   "
32992|NCT02853916|"     The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and     explore dose-response relationship by comparing two different doses.      The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood     glucose.   "
32993|NCT02853903|"     The aim of this study is the efficacy of autogenic and allogenic natural killer (NK)     immunotherapy on recurrent solid tumors.   "
32994|NCT02853890|"     Obstetric analgesia is a requirement of our times. The different applicable methods vary in     effectiveness. The essential part is represented by epidural analgesia which remains one of     the most effective methods. It is important to know other methods to respond to all requests.     The applications of these methods, patient satisfaction and psychic experience, complications     or incidents remain poorly or partially evaluated in France.      The main objective is to describe the different techniques of anesthesia/analgesia actually     used in France for the management of pain during vaginal deliveries and cesarean sections on     a representative sample of all maternity hospitals at a given time(7 days per maternity     hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).      Secondary objectives will be multiple :        -  Describe the results of analgesic methods on the physical pain of patients during labor          by a global visual analog scale        -  Describe the feeling of pregnant women relative to the different anesthesic and          analgesic techniques, by an analysis of the questionnaire responses        -  Describe the frequency of adverse events of birth   "
32995|NCT02853877|"     This study will evaluate the effectiveness of financial incentives and messaging tailored to     individual goals and aspirations to promote and sustain weight loss. This is a 2-arm     randomized controlled trial that will recruit eligible employees at a large university to     participate in a 3-month weight loss program, followed by a 3-month follow-up period. The     primary outcome will be change in autonomous motivation for weight loss.      The study hypothesis is that intervention group participants will have a greater increase in     autonomous motivation for weight loss than participants in the control group at 12 weeks.   "
32996|NCT02853864|"     The purpose of this study is to determine the effect of gender on pharmacodynamic interaction     of propofol and dexmedetomidine, exploring the effect of gender on propofol unconsciousness     median effective concentration with different dose dexmedetomidine.   "
32998|NCT02853838|"     The purpose of this research is to determine the effect of prolonged slow expiration     techniques, provoked coughing and standard therapy compared to chest wall manual vibration     and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of acute     bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and use of     supplementary oxygen.   "
32999|NCT02853825|"     Every program element was designed to ensure that all children in the areas served will live     in stable, happy, healthy family situations. The JFCS Healthy Families/Healthy Children     program will provide relationship skill enhancement interventions. All program participants     in the intervention group will have acces to: parenting skill enhancement interventions,     employment readiness and/or situation enhancement, as well as financial knowledge and/or     situation enhancement.   "
33000|NCT02853812|"     The proposed research is to identify the brain areas activated or deactivated by tinnitus in     humans. The identification of these areas is expected to be able to treat tinnitus refractory     to traditional therapies by methods of brain stimulation. Furthermore, this technique would     be very useful to verify the effectiveness of any treatment to relieve tinnitus.      The brain activation measured during fMRI will be performed in a position of rest, after     inhibition of tinnitus, and after application of a sound that does not inhibit tinnitus. This     comparison will identify specific brain areas activated or deactivated by tinnitus.   "
33027|NCT02853461|"     In this study the investigators sonicate the bearing components of the explanted hip     prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and     quantitatively). The hip prosthesis bearing components are composed from different material.     The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic,     metal and polyethylene prosthesis components through microbiologic analysis of sonicates.   "
33028|NCT02853448|"     There are many instances where there is no access to a centrifuge (Emergency wards, EMT     truck, battle field, etc.) or when a result is needed immediately (myocardial infarction); a     new collection tube which could separate serum and plasma from whole blood immediately upon,     if not during, collection, would be extremely beneficial. Such a new tube could save time and     cost by eliminating centrifugation steps that are currently required to obtain serum and     plasma.   "
33001|NCT02853799|"     Continuous enteral feeding is the most common type of nutrition used in critically ill     patients despite being non-physiologic, as all mammalian alimentary tracts have been designed     for intermittent ingestion of nutrients. The small numbers of randomized controlled studies     that have compared intermittent gastric feeds (IGF) to continuous gastric feeds (CGF) in     intensive care units have demonstrated that IGF is safe, feasible and have the shorter time     to goal nutrition. Studies of healthy adults have also demonstrated that the mean glucose     concentration (MGC) is lowered when bolus enteral feedings are used instead of continuous     feeds; these changes in glucose-insulin metrics might be beneficial to a critically ill     patient population where stress hyperglycemia is common. This study will compare the effects     of CGF and IGF in a critically ill medical patient population. Glucose-insulin dynamics for     each type of enteral feed will be analyzed by performing a randomized crossover study to     compare the effects of CGF and IGF on MGC, total insulin infused, glucose variability (GV),     episodes of hypoglycemia and maximum glucose concentration values.   "
33002|NCT02853786|"     The Language Environment Analysis (LENA) system is a specific tool for the language     environment analysis. Children aged from 18 months to 6 years old, with cochlear implants     (CIs), wear an electronic device during a day and their language interactions are registered.     Then the investigators can analyze with a specific software four different parameters (adult     words, conversational turns, child vocalizations and media exposure) and compare them to the     language ability of the children assessed by a speech therapist. With the results, the speech     therapist can advise the parents how to improve the language environment to help their     children with CIs for their language development. Parents are encouraged to follow these     advices at home during few months (5 months +/-1 month). Then there is a new registration of     the LENA device and another language assessment are performed, to see if there is any     improvement. The investigators also measure the family participation.      Hypothesis : There is an influence of the language environment measured by the LENA system on     language development in children with cochlear implants.   "
33003|NCT02853773|"     This study aims at investigating the acute influence of artificially sweetened beverages     consumption (as compared with sugar-sweetened beverages and water consumption) on brain     responses to the viewing of food images, on physiological responses (gut-derived hormones and     lipid metabolites) and on the food intake behavior.   "
33004|NCT02853760|"     Using a within-subject design, 42 healthy participants were randomly exposed to three     different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary     control situation (3.5 hours each). Measures included the Feeling Scale, Felt Arousal Scale     and a Mood Survey Scale. Univariate ANOVAs were used to analyse differences between the     conditions.   "
33005|NCT02853747|"     The project is designed as a large scale, cross-sectional study. The aim of the study is to     investigate the association of micro- and macrovascular function with physical fitness and     body composition in primary school children.   "
33006|NCT02853734|"     The research aims to compare the inflammatory status of visceral adipose tissue from obese     patients depending on the presence and severity of periodontitis, in order to establish a     potential causal link between the severity of the bacterial contamination and insulin     resistance.   "
33007|NCT02853721|"     150 patients divided into two groups.The experimental group was submitted at the assay of     iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum     calcium and phosphorus.   "
33008|NCT02853708|"     The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic     Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that     produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the     epidemiology of ESBL producing ST131clonal group in our university hospital. All patients     with an infection due to ESBL E. coli will be prospectively included for a 2-year period.     ST131 isolates will be identified and risk factors associated to ST131 will be determined in     comparison to non-ST131 ESBL E. coli.   "
33009|NCT02853695|"     By means of a questionnaire the investigators will study the implementation of hysteroscopy     in Flanders and the Netherlands   "
33010|NCT02853682|"     The glycocalyx is a layer of proteins and complex sugars covering the endothelium of vessels.     Its role as capillary filtration control is important. In case of alteration of the     glycocalyx, experimental models and some clinical studies show an increased capillary leak     responsible for interstitial edema. The analysis of glycocalyx in routine care is important     to guide volume expansion. Indeed, the literature provides evidence about the poor prognosis     of excess water and its impact on organ. This analysis challenge is to justify filling     solution of choice according to the characteristic of this capillary leakage.   "
33011|NCT02853669|"     Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve     which shares in nerve supply of knee joint has a hypothetical advantage of better pain     management with less motor affection. Also, it has a clear anatomical landmark that will     increase the success rate (femoral artery) (*).On the other hand, being a branch of the     femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness.     Likewise, the great variation of the knee nerve supply.      This prospective double-blinded randomized controlled trial is comparing ultrasound guided     adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients     undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early     mobilization and better physiotherapy.      This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer     opioids consumption with the same or better pain score.   "
33012|NCT02853656|"     Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of     pregnancies; preterm birth can lead to complications for the baby.      When mothers are identified as being at risk of going into preterm birth (giving birth within     the next 14 days) there are several treatments available that may help reduce the likelihood     of complications for the baby. These treatments usually need to be started within 24 hours so     it is very important that diagnosing preterm labour in not only fast but accurate.      There are several methods commonly used within hospitals for diagnosing mothers who may be at     risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and     phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).      The purpose of this study is to compare the two tests to see which is more accurate at     predicting preterm birth.   "
33014|NCT02853630|"     This study is a multicentre, randomized, open label on comparison of pancreatic beta cell     recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for     96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in     Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus     Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin     secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes     will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in     terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction     in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement in     insulin sensitivity, Improvement in oral disposition index, Percentage of patients reaching     the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study population     and General safety in terms of occurrence of adverse events   "
33015|NCT02853617|"     AV0328 is a novel vaccine candidate intended to raise antibodies to the glucosamine backbone     of naturally occurring Poly N-acetyl glucosamine (PNAG), a capsular polysaccharide expressed     on the surface of a wide array of microbes.      AV-101-16: A single and repeat dose, dose-escalation phase I/II study to evaluate the safety     of intramuscularly administered AV0328. Approximately 16 subjects will be enrolled at a     single U.S. center, based on 4 subjects per dose group. The study will consist of 3 parts:     Part 1 will be a single dose, dose escalation study; Part 2 will assess the effect of a     second dose of AV0328; Part 3 will assess the ability of a booster injection of AV0328 at     Month 6 to restore protective titers against N. meningitidis B16B6 bacteria.   "
33016|NCT02853604|"     High-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy     and radiation therapy. This is a group of patients with a significant unmet need. The     estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and     the prognosis is very grave for those who experience a recurrence.      The purpose of the study is to compare the disease free survival (DFS) of ADXS11-001 to     placebo administered following CCRT with curative intent in subjects with HRLACC.   "
33017|NCT02853591|"     This study seeks to evaluate post-operative patient pain and quality of life, and     intra-operative hemodynamic status and changes in inflammatory markers, with use of a     pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum     pressure settings.   "
33018|NCT02853578|"     National clinical trial, phase III, multicenter, single-arm, efficacy study, 80 participants     of both sexes, aged equal or more than 12 and less than 65 years. The group will use Busonid®     (budesonide 200mcg and 400mcg) one application (inhalation) of 200 mcg every 12 hours (400mcg     / day). During follow-up visits if the participant has not shown an increase in forced     expiratory volume in one second greater than 12% and greater than 0,20L or 200ml in     spirometry compared with baseline visit, will increase the dose to 800 mcg / day (2x 400 mcg     day).      The study aims to revalidate by the National Health Surveillance Agency (ANVISA) the     registration of the drug Busonid® which there is a vast scientific literature on the     pre-clinical and clinical evidence that the efficacy and safety of budesonide. Thus, outlined     is a single-arm study, which is applied to the study of the group of participants the same     intervention for a certain period and the participants are evaluated for response.   "
33019|NCT02853565|"     To evaluate CAN008 safety, tolerability, and pharmacokinetics (PK) of CAN008 when     administered concurrent Plus Concomitant Temozolomide During and After Radiation Therapy in     Patients with Newly Diagnosed Glioblastoma Multiforme.   "
33020|NCT02853552|"     The overall study purpose is to evaluate the safety, feasibility and acceptability of advance     distribution of misoprostol to be used as 'first aid treatment' administered by the woman     herself or her family to help treat excessive bleeding in home births.   "
33021|NCT02853539|"     Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral     nutrition (HPN). Denosumab represent a new drug, which helped to prevent osteoclast. The aim     of the study was to assess its value in chronic intestinal failure patients.   "
33022|NCT02853526|"     To date, there is no treatment strategies for these patients according to American     Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus.     Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment     (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT     and CPTV.   "
33023|NCT02853513|"     The scientific approach of this project proposes to build a cohort of psychological     injuries post-attack of 13 November 2015. This is called patients involved, ie patients     who directly witnessed the events and having the most either came under automatic gunfire or     were close to an explosion, whether or not physically injured.      The main objective is to define and validate a model of transition from acute stress disorder     (ASD) to posttraumatic stress disorder (PTSD) for better detection of the risk of unfavorable     and thus better patient supported.      The first step is to determine independent risk factors found in analytic prospective cohort     study.      Bayesian models are well suited to exercise because they can integrate (i) the context     related to the patient, (ii) the context related to the trauma itself, and (iii) the     immediate reactions and long-term to the latter . They are particularly suited to     understanding the brain disordered by saying down information (prior probability) wrong by     improper memory of the traumatic event. The confrontation of these descending information and     perceived bottom-information could be partly responsible for the symptoms of PTSD.      Once validated, the model will characterize the individual level the most at risk of     unfavorable patients (calculating a probability of developing PTSD) and to assess the     epidemiological impact on long-term cohort of event considered.      These determinations are necessary prerequisites to optimize the means of support for these     current and future casualties.      The investigators main objective is to define a Bayesian model describing a resilient     functioning facing a trauma which also allows to describe a possible evolution of the ASD to     PTSD by an error.      The state of PTSD or not will be determined by the PCL-S scale.   "
33024|NCT02853500|"     This research study is studying the Surefire Infusion System (Surefire) for increasing     delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage     Hepatocellular Carcinoma (HCC) (Barcelona Clinic Liver Cancer (BCLC) class B; locally     advanced, liver restricted disease patients.      The names of the study interventions involved in this study are:      -Trans-arterial chemoembolization (TACE) with or without the utilization of Surefire   "
33029|NCT02853435|"     This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety,     tolerability, and relative bioavailability of the 2 free base tablet formulations (related     compound [RC] and high shear wet granulation [HSWG]) compared to the reference capsule     formulation under fasted conditions. This is a 3-period; cross-over study that will guide     which gepotidacin formulation will be used for future studies. Following review of     pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed     with Parts 1b and 2.      Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the     selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected     gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will     be evaluated under fasted conditions.      The duration of the study (from Screening to the Follow-up visit) will be approximately 44     days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The     approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3     treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12     Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.   "
33030|NCT02853422|"     The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical     and therapeutic decisions.   "
33031|NCT02853409|"     The purpose of this study is to evaluate possible changes in quality of life related to     health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of     follow-up.   "
33032|NCT02853396|"     Stigma is a significant concern for those who experience psychosis. People with psychosis are     the most stigmatised group of all mental health difficulties. There is a lack of research     examining the effectiveness of psychological therapies for people who experience psychosis     who are also experiencing negative impacts of stigma. To date, all studies examining stigma     therapies have been conducted with outpatients and no support have been developed for     inpatients. The aim of this study to conduct a pilot randomised controlled trial of a brief     therapy (based on cognitive behavioural therapy)to help participants cope with stigma. It     will be compared to a educational control intervention. Both therapies will last     approximately two hours and be conducted in one or two sessions by the principal investigator     (clinical psychologist). Participants will be given a number of questionnaires assessing a     number of outcomes such as impacts of stigma, depression, recovery, and self-esteem.     Participants will be assessed on these measure prior to the therapy, post therapy and at     follow-up.   "
33033|NCT02853383|"     The purpose of this study is to determine COPD prevalence among patients registered in the     healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of     Moscow).      To describe the clinical profile of COPD patient who is under outpatient surveillance at     polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity,     occupation), smoking status, disease duration, disease severity grade, distribution by     disease phenotype, disease exacerbation rate in the setting of real-life clinical practice).   "
33034|NCT02853370|"     Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered     as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and     represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of     differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an     almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the     disease pursues an aggressive course and most patients die of lymphoma progression within 3-4     years.      Retrospective studies have indicated that purine analogous achieved very high response rates     in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of     differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in     combination with chemotherapy has been reported to be very effective in producing a rapid     clearance of neoplastic cells.   "
33729|NCT02844309|"     The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed     Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following     by thalidomide and prednisone maintenance therapy.   "
33035|NCT02853357|"     The purpose of this study is to determine the short-term effects of thoracic spine thrust     manipulation on participants with low back pain. Participants in this study will be     randomized to receive either the lower thoracic spinal manipulation and a standard set of     exercises, or a sham manipulation and the same standard set of exercises. It is hypothesized     that thoracic manipulation when combined with core strengthening exercises will have positive     short term improvements in pain and function for patients with LBP as compared to a sham     manipulation combined with core strengthening exercises.   "
33036|NCT02853344|"     The purpose of this study is to assess the safety and efficacy of monotherapy pembrolizumab     (MK-3475) in participants with renal cell carcinoma (RCC). There will be two cohorts in this     study: Cohort A will consist of participants with clear cell (cc) RCC and Cohort B will     consist of participants with non-clear cell (ncc) RCC.   "
33037|NCT02853331|"     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475)     in combination with axitinib versus sunitinib monotherapy as a first-line treatment for     participants with advanced/metastatic renal cell carcinoma (mRCC).      The primary hypotheses of this study are: 1) The combination therapy of pembrolizumab plus     axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS)     as assessed by blinded independent central imaging review per Response Evaluation Criteria in     Solid Tumors version 1.1 (RECIST 1.1) and 2) the combination therapy of pembrolizumab plus     axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).   "
33038|NCT02853318|"     This phase II trial studies the combination of pembrolizumab, bevacizumab, and low dose oral     cyclophosphamide in treating patients with recurrent ovarian, fallopian tube, or primary     peritoneal cancer. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may block     tumor growth in different ways such as boosting your own immune system to find, recognize and     kill tumor cells as well as by blocking the growth of new blood vessels necessary for tumor     growth and nutrition. Drugs used in chemotherapy, such as low dose oral cyclophosphamide,     work in different ways to stop the growth of tumor cells, either by killing the cells, as     well as by further enhancing your own body's immune response against cancer cells. As these     three drugs have all been shown to improve the immune response against cancer cells giving     pembrolizumab, bevacizumab, and cyclophosphamide together may work better in treating     patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.   "
33073|NCT02852863|"     To identify by ultrasound the possible changes in gastric volume and content after chewing     gum for an hour in volunteers with complete fasting (more than 8 hours).   "
33039|NCT02853305|"     The purpose of this study is to determine the efficacy and safety of pembrolizumab (MK-3475)     with or without chemotherapy versus chemotherapy alone in participants with advanced or     metastatic urothelial carcinoma (bladder cancer).      The primary hypotheses are that pembrolizumab plus chemotherapy is superior to chemotherapy     alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in     participants with programmed cell death ligand 1 (PD-L1) positive tumors and in all     participants (includes those participants with PD-L1 positive tumors and those with PD-L1     negative tumors).   "
33040|NCT02853292|"     Intravenous high-dose amoxicillin is a frequently prescribed antibiotic in intensive care     units and infectious disease departments, in such indications as meningitis, endocarditis,     listeriosis, or documented susceptible osteo-articular infections.      Among possible side effects is the occurrence of amoxicillin crystalluria. Its incidence is     unknown. It is deemed uncommon but literature is poor and its incidence is probably     under-estimated. It can be complicated with hematuria or acute renal failure and may require     renal replacement therapy. measures that can limit the impact of this nephrology     crystalluria.      Since the beginning of 2014, because of the occurrence of a case of macroscopic crystalluria     in our unit and a pharmacovigilance alert, it has been decided to search systematically for     amoxicillin crystalluria in several centers of the north-east of France. The investigators     propose to study these patients, through an observational study of a multicenter longitudinal     cohort, to assess the incidence of amoxicillin crystalluria during high dose intravenous     amoxicillin treatment.   "
33041|NCT02853279|"     One hundred participants from a combination of (a) local advertisements and/or (b) those     whose details are held on a research database (of previous volunteers indicating willingness     to be contacted about future studies) will be sought to volunteer for this study. Written     informed consent will be gained following greater than 48 hours for the purpose of reading     the Participant Information sheets. The study will then involve two stages (i) recruiting     participants for a cross sectional analysis of the relationship between physical activity     levels and cardiovascular and cognitive function, and (ii) a longer exercise training study     in a subsample of these volunteers (i.e. participants who volunteer to exercise train).     Participants for stage 1 will then visit the laboratory in the University on three occasions     (over a three week period) to be assessed for body composition, exercise tolerance, current     physical activity levels, cognitive function and arterial and cardiac health. Each visit will     last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear     for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2     will include only those participants who have volunteered for the exercise training component     (approx 60). These participants will then be randomly divided into two groups. Both groups     will exercise three times per week for 12 weeks duration. Group 1 will exercise in a     traditional manner at a moderate intensity, whilst the second group will exercise at a heavy     intensity but in short bursts. Both groups will complete the same amount of work but in two     differing modes. Both groups will attend the laboratory twice per week for supervised     exercise sessions and also perform one home based 30 minute brisk walk per week. All     participants will be re-examined at 12 weeks.   "
33051|NCT02853149|"     This study determines in people with chronic SCI the health and functional impact and user     acceptance and satisfaction - of a 6-month comprehensive Lifestyle Intervention; the impact     and user acceptance/satisfaction of a Complementary Caregiver Curriculum (CCC) on SCI     caregiver health and function and whether the complementary caregiver curriculum (CCC)     enhances health and functional benefits obtained by the SCI dyadic partner enrolled in the LI     program.   "
33052|NCT02853136|"     To investigate the influence of fluvoxamine on the pharmacokinetics of BI 409306   "
33053|NCT02853123|"     The primary objective of the present study is to evaluate the effect of tiotropium +     olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity     of breathlessness during the 3min constant speed shuttle test (CSST).      A secondary objective is to explore the relationship between reductions in breathlessness     during the 3min CSST and reductions in breathlessness during activities of everyday living as     measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following     bronchodilator therapy.   "
44221|NCT02706873|"     This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX)     monotherapy in MTX-naïve subjects with moderately to severely active rheumatoid arthritis   "
33042|NCT02853266|"     Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism. It has     been reported worldwide, but it is ten times more common in Asian population. It is the     second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of     cases between 1 and 5 years, with a maximal incidence around the age of 12 months.      KD is not well understood and the cause is yet unknown. It may be an autoimmune disorder. The     problem affects the mucous membranes, lymph nodes, walls of the blood vessels, and the     heart.The clinical picture of KD associate a persistent fever and an antipyretics resistance     with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral.      There is currently no vaccine available against Kawasaki disease so it is extremely important     to be able to recognize symptoms before they set in and become too severe.      Chagas disease (CD) is caused by the parasite Trypanosoma cruzi. Acute CD occurs immediately     after infection, may last up to a few weeks or months. Infection may be mild or asymptomatic.     There may be fever or swelling around the site of inoculation, and acute infection may result     in severe inflammation of the heart muscle. The notion that the pathology of CD has an     autoimmune component was initially based on the finding of circulating antibodies binding     heart tissue antigens in patients chronically infected with T. cruzi.      A recent study reports a possible antigen (non-cruzi-related antibody NCRA) mimicry     characterized by a serological reactivity to a well-defined T. cruzi antigen in blood samples     from individuals not exposed to the parasite. The measured seroprevalence of such     cross-reactivity is in favor of a highly prevalent immunogen acquired in childhood.      There are similarities in mechanism of CD and KD: it could be interesting to explore the     presence of NCRA in blood samples from adults with a history of KD.      The objective of the study is the measurement of the biomarker NCRA in serum in adults with a     history of KD compare to a control population. This measurement and the prevalence may permit     to associate the NCRA to a possible pathogenic agent.   "
33043|NCT02853253|"     SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare     the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants <     29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%.     This study will offer new information for optimizing the management of preterms requiring     parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may     decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence     of BPD.   "
33044|NCT02853240|"     Cerebral palsy (CP) is a group of non-progressive motor dysfunction but often changing,     secondary to injury or brain abnormalities that occur in early stages of development. In     children with CP, the brain injury lead to a delayed motor development in the first weeks,     associated with muscular spasticity. Drug treatments include oral treatments (baclofen and     tizanidine) and injectable treatments like Botox (intramuscular injection) and neurolysis     with alcohol or phenol (local injection into the nerve).      Regarding botulinum toxin, there is no study questioning its effectiveness. However, no     publication on the pathophysiology of human muscle of the CP child after toxin injection was     found. The action of the toxin on the neuromuscular junction (NMJ) and muscle structure is     unknown in children with CP.      The primary objective of this study is to describe structural abnormalities of the CP child's     muscle following multiple toxin injections in terms of NMJ fragmentation and axonal     sprouting.      Secondary objectives:      To evaluate the relationship between:        -  The severity of the motor impairment and muscle structural abnormalities.        -  The clinical measure of spasticity and muscle structural abnormalities.        -  To compare the structure spastic muscles with toxin injections and spastic muscle          without toxin injections      For muscles with multiple toxin injections, assessing the relationship between :        -  The number of toxin injections and muscle structural abnormalities.        -  The date of the first injection and muscle structural abnormalities.        -  The total dose of injected toxin in the muscle and its structural abnormalities.        -  The nature of the product injected in the muscle and its structural abnormalities.      This innovative study will improve the knowledge on the effects of long-term botulinum toxin     injections on the muscle (and therefore its safety in usual care), on the spastic muscle NMJ     of CP children, on the pathophysiology of the CP child's muscle.      All the visits all acts will be performed according to usual patient follow-up. Only a biopsy     will be performed in addition, taken from an injected muscle during a planned operation. A     biopsy may also be performed on a muscle without toxin injection if the act is made possible     by the planned surgery. No biopsy will be made on a muscle that would not require surgery.   "
33045|NCT02853227|"     This paper will present a specific tool for evaluation of cosmetic results after breast     conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap.     Introduction of a breast score system using digital photography seems to be a reliable tool     for estimation of cosmetic results after breast surgery. The method has been employed on a     specific group of 346 consecutive patients operated for breast cancer with breast conserving     surgery. For the purpose of this study breast score system was tested on patients with free     flap breast reconstruction (DIEP flap).   "
33074|NCT02852850|"     Molecular imaging with infliximab antibody with FITC has the potential to predict therapeutic     responses to infliximab antibody and can be used for personalized medicine in ulcerative     colitis.   "
33046|NCT02853214|"     Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma     accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma     commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance     (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no     lifestyle or environmental exposure factors have been identified that are consistently linked     to increased risk of MM, MGUS or the transition between the two.      The overall goal is to identify risk genes for dysglobulinemia, and more specifically     Multiple Myeloma. This will involve the conservation of cells in a bank and genetic     sequencing on samples obtained from families with at least two cases of dysglobulinemia.     Material used for sequencing is likely to include fresh peripheral blood cells or     lymphoblastoid lines established from peripheral blood lymphocytes of patients.   "
33047|NCT02853201|"     Mechanical ventilation is a life-saving treatment for critically ill patients who are unable     to breathe on their own. At the time of recovery, separation from the ventilator is performed     without difficulty for the majority of patients. However, approximately 15% of patients     experience extubation failure, i.e. they are re-intubated after extubation within a period of     48 hours to 7 days. Patients who fail extubation are exposed to a longer duration of     mechanical ventilation, higher rates of ventilator-acquired pneumonia, higher morbidity, and     higher ICU mortality. Therefore, it is of relevant importance for clinicians to identify     patients who are at risk of extubation failure as soon as ventilation has been discontinued.     However, current clinical assessment has poor predictive performance: some physiological     variables can be helpful but can only be obtained invasively using esophageal and gastric     catheters.      Using ultrasound measurements to assess the activity of the respiratory muscles could be of     particular interest for this purpose. By showing an early recruitment of the accessory     muscles as well as diaphragm dysfunction or hyperactivity, ultrasounds could help clinicians     pay greater attention to such patients and therefore try to apply specific therapeutics.     There are several advantages to ultrasounds: they are non-invasive, available in most     intensive care units, and previous studies have reported reasonable reliability of the     measurements.      In the present study, we aim to assess the contractility of the respiratory muscles     (diaphragm, intercostal, and sternocleidomastoid) using ultrasounds to identify patients who     may be at risk of extubation failure and/or ICU readmission.   "
33048|NCT02853188|"     The aim of the study is to evaluate if the plasma activity of the tissue factor at the time     of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction     (surgery or two first cures of chemotherapy), can be a predictive factor of venous     thromboembolism disease in the year which follows the diagnosis, independently of the other     parameters.   "
33055|NCT02853097|"     This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)     in blood from patients with prostate cancer that does not respond to hormone therapy and has     spread to other places in the body. Studying samples of blood from patients with prostate     cancer may help doctors to learn more about the changes that occur in tumor cells over time     and how they become resistant to anti-cancer drugs.   "
33056|NCT02853084|"     This is an open label, single arm trial to evaluate the efficacy, safety, and     pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).   "
33057|NCT02853071|"     This study evaluates efficacy, safety and quality of life in patients affected by metastatic     breast cancer RH+/ HER2- and treated by estramustine phosphate.   "
33058|NCT02853058|"     High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but     also with stillbirth and distress during labor.   "
33059|NCT02853045|"     Despite a large diffusion for generic anti-hypertensive, they are not currently used.      Clinical validation studies could be better to convince users and prescribers than     pharmacologic validation only.      A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place     in real conditions of care for hypertensive patients, for a manometer control criteria.      The aim of the study is to test the hypothesis of non-inferiority for generic     anti-hypertensive for blood pressure control.   "
33075|NCT02852837|"     The purpose of this study is to evaluate the tolerability, safety and the pharmacokinetic     (PK) profile of daratumumab in Chinese participants with relapsed or refractory multiple     myeloma (RRMM) who failed at least 2 prior lines of systemic therapy (Part 1 and Part 2); and     to evaluate the tolerability and safety of daratumumab in Chinese participants whose prior     therapy included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who have     demonstrated disease progression on the last therapy (Part 3).   "
33060|NCT02853032|"     Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral     prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a     safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the     large variability in the magnitude of clinical outcomes reported is likely related to the     current lack of knowledge of ideal side of stimulation (left vs right) and the limited     precision in the targeting of brain circuits needed to obtain an optimal treatment response.     In this protocol the investigators will: 1) generate individualized treatment plans based on     an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based     connectivity analysis to guide the delivery of adjunct, imaging-based & robotically delivered     rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program     providing integrated evidence-based psychotherapy and pharmacological management (Treatment     as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as     other indicators of clinical change, to determine whether compared with TAU, addition of     adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed     to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the     potential correlation of connectivity changes with clinical outcomes.   "
33061|NCT02853019|"     Anhedonia and avolition reflect emotional and motivational disorders, respectively. However,     if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms     remain poorly understood, and existing treatments are inefficient on these symptoms. The     literature suggests that the impairment does not concern emotion or motivation per se, but     rather their influence on cognition. This project aims at using recent advances in the     fundamental domain to better understand the cognitive and neuronal mechanisms of the     patients' alterations, and especially how emotion and motivation influence cognition in     schizophrenia.   "
33062|NCT02853006|"     The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It     requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).      This study is about the set up of an innovative test for lung cancer prognosis, based on     biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.      The main goal of this study is to approve the diagnostic value of the molecular signature of     the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with     lung cancer.   "
33063|NCT02852993|"     Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC     transfusion has proven its efficacy regarding mortality and morbidity, but it is not without     side effects. The infectious side effects of transfusion are largely considered under     control, non-infectious side effects are taking center stage. Seeking explanations for the     beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and     optimal use of this precious resource.      The investigators aim to study the impact of donor and RBC characteristics on patient     survival.   "
33064|NCT02852980|"     Retrospective study to estimate screening of the type 2 diabetes of women who had childbirth     in the Hospital center Rene Dubos and having gestational diabetes.   "
33065|NCT02852967|"     This study is being conducted to evaluate the safety, tolerability, and efficacy of KD025 in     adult subjects with moderate to severe chronic plaque psoriasis.   "
33066|NCT02852954|"     Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be     questionable whether tumor cells express PIBF for escape of immune system. There are some     studies in the literature that evaluate PIBF expression of different malign cells (e.g.     glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary     brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has     been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF     expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF     expression levels in the endometrial cancer cells.   "
33067|NCT02852941|"     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume,     Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance     cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. Ilmenau) in     stable renal transplant recipients Nutritional status was measured by Tanita 418 Monitor.   "
33102|NCT02852486|"     The purpose of this study is to evaluate treatment-free remission after imatinib     discontinuation in patients with chronic myeloid leukemia with deep molecular response.     Before discontinuation, patients will receive pioglitazone associated with imatinib during 3     months.   "
33068|NCT02852928|"     Generation of a common European database and biobank Continous assessment and implementation     of guidelines and treatment protocols Establishment of a large observational cohort of chILD     patients Determination the value of outcomes used in child Assess treatment variations used,     deliver data from defined protocols and linked outcomes   "
33069|NCT02852915|"     The purpose of this study is to compare the short- and long-term survival of laparoscopic     surgery and conventional open surgery for T4 colon cancer.   "
33070|NCT02852902|"     Main objective: to observationally assess the efficacy and safety of different antimicrobials     in BSI due to ESBL or carbapenemase-producing Enterobacteriaceae in SOT.      Secondary objectives:        1. To evaluate the efficacy and safety of different antibiotics used for the treatment of          infections caused by ESBL- and carbapenemase-producing Enterobacteriaceae in the SOT          population.        2. To compare the efficacy of different antimicrobials between SOT and non-SOT patients          (using matched controls from the non-transplant INCREMENT cohort).        3. To create a microbiological collection of ESBL- and carbapenemase-producing          Enterobacteriaceae isolated from the SOT population.        4. To provide data on specific MICs for each antimicrobial evaluated.        5. To provide data on the prevalence of specific mechanisms of resistance and their          clinical impact in the particular setting of SOT.        6. To organise an international consortium capable of developing high quality prospective          cohort studies and randomised clinical trials in the area of MDR and XDR          Enterobacteriaceae in SOT.   "
33071|NCT02852889|"     The purpose of the study was to verify the efficacy of using internal jugular vein (IJV) size     and distensibility as an index of fluid responsiveness in mechanically ventilated patients     after cardiac surgery.   "
33072|NCT02852876|"     The objective of this study is to evaluate the safety and tolerability of single rising doses     of ASP2151 under fasted condition in healthy male subjects.      The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under     fasted versus fed conditions in healthy male subjects.   "
33080|NCT02852772|"     Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment.     Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably     affecting the small vessels. In the older general population microalbuminuria is associated     with greater annual cognitive decline and has been proposed as an easily and inexpensive     measured marker predicting future cognitive function decline. Ageing of the PLH leads to an     increase of cognitive disorders and chronic renal failure incidence and could imply a common     underlying mechanism affecting the renal and cerebral microvasculature. In this setting the     investigators undertake this prospective, cross-sectional, case-control study to determine     whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good     combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a     marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years     and with cART-sustained immunovirological control for at least 1 year.   "
33081|NCT02852759|"     Insulin resistant volunteers will undergo an 8-week cold treatment, 2 hours per day, to     selective regions of the body enriched with brown fat including neck, supraclavicular and     interscapular regions) in combination with electroacupuncture (EA). Their insulin sensitivity     and glucose and lipid homeostasis will be measured. The brown fat activation will be     determined by analyzing fat biopsy samples and/or positron emission tomography and computed     tomography (PET/CT)-scans.   "
33082|NCT02852746|"     The study aims to compare the performance and the 3D shoulder kinematics of volleyball     attackers with and without scapular dyskinesis and shoulder symptoms in two physical     performance measures of the upper extremity, and correlate their outcomes with a     self-reported measure of function of the upper extremity.   "
33083|NCT02852733|"     The purposes of this study are :        -  To know and to understand frequency and variability (quantitative and qualitative) of          end-of-life emergencies in nursing homes.        -  To know and to understand practices applied in these situations depending on the          institution and the different reasons of hospital use.        -  To know and to understand the practical and organizational elements, in nursing homes,          that can determine a (re) hospitalization or an end-of-life   "
33084|NCT02852720|"     Transversus abdominis plane (TAP) block provides effective analgesia and is now a standard of     care for analgesia after cesarean section. There is no information on levobupivacaine     pharmacokinetics post TAP after pregnancy.      Objective: Generate a pharmacokinetic levobupivacaine model and its effect on the     electrocardiogram (ECG).      Method: The investigators will study 12 healthy term pregnant patients, scheduled for     elective cesarean section under spinal anesthesia. A bilateral TAP block is performed with 20     ml 0.25% levobupivacaine with epinephrine 5 ug/ml. Sensory block will be assessed at 1-2-6     and 12 hours post puncture. 2 ml of venous blood will be obtained at 2-5-10-30-45-60-90 and     180 minutes. With a Holter machine we will study the effect of levobupivacaine plasma levels     and the QTc changes.      Expected results: 1) Plasma levobupivacaine levels; 2) Changes in QTc .   "
33085|NCT02852707|"     This study compares the performance and 3-dimensional shoulder kinematics between sides in     unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers)     and non-athletes during two physical performance measures of the upper extremity, one in an     open kinetic chain position (unilateral seated shot put test) and the other in a closed     kinetic chain position (upper quarter Y balance test)   "
33086|NCT02852694|"     The purpose of this study is to compare the effectiveness of weekly subcutaneously     administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition     -free 1-year remission compared with:        -  daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease        -  subcutaneously administered adalimumab in high risk paediatric Crohn's disease   "
33087|NCT02852681|"     This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period,     two-sequence crossover study was conducted under medical supervision in 28 healthy female     volunteers.   "
33103|NCT02852473|"     This study involves a breathing motion assessment in healthy subjects before and after     continuous positive airway pressure (CPAP) administration using MRI images.      The hypothesis for this study is that CPAP administration will significantly reduce breathing     motion. This may help cancer patients who are undergoing proton radiotherapy, so they     possibly will not have to hold their breath during the procedure.   "
33088|NCT02852668|"     The inexorable decline in motor skills during aging provides the investigators with an     elderly population with various functional limitations. Among these, the ability to walk,     being associated with the risk of falling has been studied by several authors. The adoption     of strength and power training as an intervention strategy to reduce the negative effects     arising from the physiological or pathological process of aging has been widely discussed in     these studies. However, the effects of these interventions on biomechanical gait indicators     have not been fully debated yet. Therefore, this study aimed to compare the effects of these     two training protocols on functional capacities and biomechanical gait parameters of elderly     women.   "
33089|NCT02852655|"     This research study is studying an immunotherapy as a possible treatment for Glioblastoma.   "
33090|NCT02852642|"     Introduction: the physiological aging process induces several structural changes in the     musculoskeletal system. These, in turn, result in functional changes that are reflected in     the senescent dependency, determining the reduction in their quality of life. Power training     has been identified as ideal to mitigate the effects of aging. However, there are indications     that an intervention based on the potentiation of the stretch-shortening cycle action is a     better choice.   "
33091|NCT02852629|"     Observational two year study to evaluate the utility of a decision-support sheet on how to     proceed in case of aggravation of a patient's condition with advanced disease.   "
33092|NCT02852616|"     Narrative Exposure Therapy (NET) has been proven to be effective in the treatment of     Posttraumatic Stress Disorder (PTSD) and trauma-related depression in more than a dozen     controlled clinical trials. Symptom reduction was greatest during long-term follow-ups after     the completion of the therapy.      In the current study, we will investigate the progression of PTSD symptoms and emotional     stress before, during and after therapy. After a semi-structured interview all participants     will be asked to report in monthly telephone interviews their core symptoms. Structured     interviews after 6 and 12 months are used to validate the outcome. A convenience sample of     individuals with a PTSD will be offered participation in the study.   "
33492|NCT02847390|"     The investigators will develop a novel diabetes prescriber superuser educational program     focused on inpatient diabetes management for physicians, based on their input. The     investigators will then examine the impact of the diabetes prescriber superuser program and     an analogous diabetes nurse superuser program that is already developed on glycemic control     and other outcomes in hospitalized patients with diabetes.   "
33093|NCT02852603|"     Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge     blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD     are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to     establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This     study is intended to collect the gene information in sporadic TAAD patients and to explore     the relationship between genetic variation and the incidence of sporadic TAAD for further     study.   "
33094|NCT02852590|"     Medications are the most commonly used clinical intervention and complications associated     with their use are one of the most common causes of adverse events in health care. Adverse     Drug Reactions (ADR) are a major cause of morbidity and pose a substantial burden on limited     health care resources.      Many drugs used to treat children in hospitals are either not licensed for use in children or     are prescribed outside the terms of their product license (off-label prescribing). This is     mainly due to the lack of clinical trials in this vulnerable population, and both practical     difficulties and ethical considerations arising from involving children in clinical research.      Drugs used within the specifications of the product license might be less likely to cause ADR     compared to drugs that are either unlicensed or off-label for use in children. Few studies     have shown a significant association between pediatric off-label drug use and ADR.      To compare the probability of ADR after a licensed drug prescription versus the probability     of ADR after prescribing a drug off-label in children, we are conducting a multi-center     prospective observational study in different pediatric hospital wards in France.      The availability of electronic health records made this study feasible. An automatic data     extraction from hospital information systems has been implemented. A computer algorithm for     determining pediatric drug labelling (i.e. off-label or unlicensed use) using the French     summaries of product characteristics available in Thériaque® database has been developed.     Detection of ADRs is carried out by health care professionals and research groups using a     trigger tool and patients' electronic health records. The causality between ADRs and     suspected medications is evaluated using the Naranjo and the French methods by regional     pharmacovigilance centers. An independent pharmacovigilance board validates ADR evaluations,     assesses both of their severity and avoidability, and indicates therapeutic alternatives to     suspected medications.      This is, to our knowledge, the first large multi-center and prospective study in France that     evaluates the relationship between adverse drug reactions and unlicensed/ off-label drugs use     in hospitalized children. The results of this study will provide more information on the     prescription practice and the amplitude, nature and consequences of unlicensed/off-label drug     use in hospitalized children. It will also help identify the risk factors of ADR that could     be used to implement preventive actions, and guide future research in the field. An indirect     benefit is represented by the increase of physicians' awareness in detecting and declaring     ADRs and by communicating the results to the health professionals and to the public. This     study is funded by ANSM (the French Medicine Agency).   "
33095|NCT02852577|"     The purpose of this study was to determine whether clonazepam and paroxetine are effective in     the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and     post-treatment.   "
33096|NCT02852564|"     Phase 1 study to provide quantitative characterization of the renal elimination of ethacrynic     acid and metabolites in patients with non-muscle invasive bladder cancer (NMIBC) at the time     of transurethral resection of bladder tumor   "
33097|NCT02852551|"     A single‑center, randomized, placebo‑controlled study consisting of both a single ascending     dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability,     pharmacokinetics and effect of food using PAT‑1251 orally administered to healthy subjects   "
33098|NCT02852538|"     This study aims to measure the effect of a neurobiologically-guided intensive family based     treatment for adults with anorexia nervosa.   "
33099|NCT02852525|"     The purpose of this study is to further validate the use of probe-based confocal laser     endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a     larger patient base.   "
33100|NCT02852512|"     The aim of the study is to perspectively compare the anatomical and functional outcomes of     Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.   "
33101|NCT02852499|"     The SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of     Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on     the general population and aims to cover several areas of environmental health research,     including endocrine disruptors and air pollutants.      The main objectives is to quantify the impact of pollution during pregnancy and the first     years of life on three main health outcomes : growth, respiratory health and     neuro-development ; and to better understand the biological mechanism (such as genetic     analysis to study the role of environmental factors on genes expression as well as the role     of genetic factors on health). The objective is to include 500 families.   "
33107|NCT02852421|"     Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast     surgeries resulting in reduced narcotic consumption, reduced nausea, improved quality of     recovery, reduced chronic pain and possibly reduced metastasis with breast cancer.     Traditionally, PVB is done by multiple injections below T1-T5 transverse processes. With     multiple injections, the risk is increased for a pleural, an intraneural, and/or an     intravascular injection. Recently, ultrasonography is being used to facilitate PVB. The use     of ultrasound imaging enables real-time needle visualization during the procedure. This may     improve efficacy and reduce the chances of complication like pneumothorax. Currently, there     are no data comparing ultrasound-guided single injection technique with multiple injections     technique with regards to extent of spread for PVB. Our objective is to investigate the     extent of dermatomal spread of PVB when equal volumes of local anesthetic are injected at one     versus five paravertebral sites for patients undergoing major breast surgery. In addition,     the investigators wish to compare the performance time and duration of analgesia.      Methodology: After local REB approval, 72 patients undergoing a unilateral mastectomy with or     without axillary node dissection will be randomized to receive either single or multiple     injections PVB. The PVB will be performed in prone position under real-time ultrasound     guidance using a para-sagittal approach.The patients in single injection group will receive     single injection PVB at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham     injections. Patients in the multiple injection group will receive five injections of PVB from     T1 to T5 level. 5 ml of 0.5% ropivacaine will be injected at each level. Pleural drift will     be used as a sign of correct needle tip location and local anaesthetic spread. The pinprick     method will be used to assess the extent of dermatomal blockade, 20 minutes following the     completion of procedure. All patients will receive a standardized general anesthesia for the     surgery. Any adverse events including pneumothorax, epidural spread, LA toxicity/seizure,     total spinal, will be recorded.   "
33111|NCT02852369|"     Objective: To determine the effectiveness of an upper extremity, task oriented training     program delivered at home (TOTE Home) for people who are in the subacute recovery phase of a     stroke.      Method: A single-subject AB series design with a follow-up to assess the effectiveness of     TOTE Home which includes a maximum of 30, one hour sessions of training conducted in     participants' homes. Repeated target measures of accelerometry and level of confidence to be     analyzed throughout the study. Change scores from standardized assessments to be evaluated at     baseline, post-intervention, and follow-up time periods.   "
33112|NCT02852356|"     The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse     incubator and CultureCoin dish compared to standard big-box incubators and standard culture     dishes used for embryo culture.   "
33113|NCT02852343|"     The investigators main objective is to show that OSNA technique is as accurate as     pathological analysis (frozen section / HE staining and immunochemistry) to detect occult     lymph node metastasis (micro and macrometastasis).   "
33114|NCT02852330|"     Collection of normative voltage tomography data during and/or immediately after electrode     insertion into the cochlea using Surgical Assistant (SA16) research software and     postoperatively at activation, three and twelve months post-activation with CS19 research     software in adults who are receiving a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear     implant.   "
33115|NCT02852317|"     The purpose of this study is to assess diagnostic performance of urinary markers of detrusor     overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine     triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida     patients.   "
33116|NCT02852304|"     Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked     to decrease enzymatic activity of LAL, responsible for intracellular accumulation of     cholesterol esters and triglycerides.      The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty     liver, hepatic fibrosis that can evolve up to cirrhosis.      LAL deficiency is responsible for significant morbidity and early mortality in children,     adolescents and adults in connection with a multi visceral disease reaching the liver,     gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or     heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for     the synthesis of the LAL.      The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto     blotting paper .      Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its     rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver     biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis     (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.      Inclusion period of 12 to 18 months (100 patients).   "
33117|NCT02852291|"     Multisite randomized trial of a parenting intervention in Liberia for caregivers of young     children. Two main objectives of the Parents Make the Difference program are to teach     parents (a) skills for decreasing harsh punishments and replacing those with positive ways to     manage children's behavior and (b) skills for having more positive interactions with their     children, including interactions that encourage learning. As a result of positive changes in     parenting, the investigators expect that, over time, children's behavioral and cognitive     well-being will improve and that future abuse and poor developmental outcomes will be     prevented in the long-term.   "
33118|NCT02852278|"     The purpose of this study is to learn about rates of patient-reported disease progression in     patients with motor neuron diseases (amyotrophic lateral sclerosis, progressive muscular     atrophy, primary lateral sclerosis, hereditary spastic paraplegia) outside the clinical     setting, and the patient-reported clinical characteristics that influence this rate of     progression. All patients enrolled in CReATe Connect, a Rare Diseases Clinical Research     Network (RDCRN) Contact Registry, will be invited via email to participate in this study.   "
33119|NCT02852265|"     Women currently using or starting a combined oral contraceptive will be offered study     enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate     if they continue the COC, continue the implant, or both, and to assess adverse events and     bleeding patterns.   "
33120|NCT02852252|"     The study objective is to collect prospective data on cancer patients who undergo surgery and     intraoperative imaging. The registry will include (but not limited to) cancer type, stage,     intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and     recurrence surveillance.   "
33121|NCT02852239|"     To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral     dose in subjects with severe renal impairment and end stage renal disease not on dialysis.   "
33160|NCT02851732|"     The purpose of the study is assess the impact of and educational multifaceted intervention in     adherence to evidence based thearapies prescription (according to local guidelines) for     cardiovascular prevention in high risk patients for (lipid lowering agents, antiplatelets and     ACE Inhibitors) in 12 months.   "
33161|NCT02851719|"     To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes     additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.   "
33122|NCT02852226|"     UCSF is conducting an evaluation of a demonstration project. The aims of the CRUSH-PrEP for     Women project are to integrate the delivery of a comprehensive PrEP package for HIV-negative     at-risk women into primary care settings. The delivery of the PrEP package will leverage the     well regarded reputation of the LifeLong primary care clinicians to provide a highly     effective combination HIV prevention strategy including; PrEP, post-exposure prophylaxis     (nPEP), repeat HIV and STI testing, treatment of sexually transmitted infections. Counselling     for for sexual health promotion and services specifically designed for vulnerable women such     as staying free of violence and domestic abuse will be offered as an integrated part of this     package. UCSF will conduct evaluation activities only. The investigators expect that UCSF     will enroll 50 participants in the evaluation assessments across the 15 months of data     collection. Evaluation cohort participants will provide quantitative data to evaluate the     linkage and engagement in care among clinic attendees as well as the uptake and use of     Pre-Exposure Prophylaxis.   "
33123|NCT02852213|"     The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC     delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in     children with aromatic L-amino acid decarboxylase (AADC) deficiency.   "
33135|NCT02852057|"     This study focuses on glaucoma therapy by drug eluting contact lenses. The contact lens will     be loaded with timolol maleate and dorzolamide hydrochloride, both of which are commonly used     ophthalmic drugs. Additionally, the lenses will contain vitamin E ((+) α-tocopherol) as an     additive for achieving extended release of the drugs.      This study is to assess the safety of the drug loaded contact lenses and the effectiveness.     Effectiveness will be a drop in IOP after using the lenses.   "
33124|NCT02852200|"     Many tools to evaluate frailty have been developed. However, at the time our study was     designed, none of these instruments had been validated in terms of psychometric properties.     The aim of this study was to validate the modified version of the Short Emergency Geriatric     Assessment (SEGAm) frailty instrument in elderly people living at home.      It was an observational, longitudinal, prospective, multicentre study, set up in four     departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions     (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was     able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6     in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics,     comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was     used to study feasibility and acceptability, internal structure validity, reliability, and     discriminant validity of the SEGAm instrument.    "
33125|NCT02852187|"     Prospective randomized clinical study comparing Signus MOBIS PEEK vs SIGNUS MOBIS II ST in     patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1   "
33126|NCT02852174|"     Caring for a disabled adult, particularly those with long-lasting impairment, has been     associated with elevated levels of stress, depression and anxiety among caregivers.Recent     studies show that veteran caregivers experience higher levels of psychological distress than     caregivers in the general population, highlighting the psychological needs of this     population. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control     trial designed to test the effectiveness of a mindfulness at reducing stress, depression and     anxiety in veteran caregivers in Champaign and Danville County.   "
33127|NCT02852161|"     A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy     in detecting esophageal pathology compared to standard endoscopy.   "
33128|NCT02852148|"     The aim of the study is to evaluate participant reported quality of life, safety, and overall     performance with ACTICOAT in a clinical setting.      ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a     variety of wound types. It is widely used in routine clinical practice within the UK.     ACTICOAT is CE marked and will be used within the intended indications for use. The proposed     study is required for regulatory purposes.      Primary Objective: To evaluate change in health related quality of life, associated with     treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single     index utility scores from baseline to 3 weeks.      The study will also seek to gather and report relevant safety and performance data and     evaluate change, where applicable, for outcomes including: clinical signs and symptoms of     infection; wound length / width / depth; wound healing measures; tissue staining; pain,     adherence, and pain on application / removal; wear time; adverse events and device     deficiencies.      In total 25 participants will be recruited into the trial, comprising a minimum of 8     participants with a full or partial thickness burn and a minimum of 8 participants with a     full or partial thickness chronic wound. All participants will have their wound dressed using     ACTICOAT, and will be followed-up for 3 weeks.   "
33129|NCT02852135|"     The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages     over the classic LMA.Several publications have reported the successful, safe use of Laryngeal     Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no     studies that have examined the application of LMA in patients during lateral positioned     laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA     Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general     anesthesia.   "
33130|NCT02852122|"     The investigators determine the target number as 54 patients based on the following reasons:     (a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to     99.9 ng/ml was 21% (166/767 cases in a systemic review) [8]; the estimated sample size would     be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI     scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming     a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic     number for the high risk prostate cancer patients in our hospital annually is ~70, about 6     patients a month. It is clinically feasible to recruit 3 patients a month until 18 months     since the study begin. The study could be completed in 2 years with 54 cases   "
33168|NCT02851628|"     The investigation is a prospective non-blinded and semi-randomized clinical investigation.     The investigation is designed to assess the alternative sizing model which the trial mask     concept is based on and how it compares to a conventional sizing present in the Prototype     Full Face Mask (PFFM) mask.   "
33131|NCT02852109|"     The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury     and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion     tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the     ADC(apparent diffusion coefficient) value of relational interesting area（corpus     callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional     anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale)     and coma time,so that the investigators can quantify the damage degree of patients' white     matter fiber.By using fiber tractography the investigators can have the extent of recovery of     the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the     clinical decision and the judgement of prognosis).   "
33132|NCT02852096|"     One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu)     immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or     multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical     method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral     heterogeneity.   "
33133|NCT02852083|"     This is a Phase II, multicentre, open-label, randomized, and controlled study, evaluating the     efficacy and safety of combined modularized treatment of treosulfan, pioglitazone and     clarithromycin in patients with with squamous and non- squamous cell lung cancer,     respectively after platin failure.   "
33134|NCT02852070|"     Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two     common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of     lower respiratory tract infection.      Assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml),     including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy, and     other bronchoalveolar lavage related adverse events.   "
42273|NCT02732327|"     This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam     (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or     linezolid as empiric therapy in febrile neutropenic adults with cancer   "
33136|NCT02852044|"     For decades, it has been known that post-meal blood glucose concentrations were associated     with the risk of T2D, which was reflected in early diagnostic guidelines. The oral glucose     tolerance test (OGTT) has been used since at least 1923 and has remained the most common test     for assessing glucose tolerance. Arterial blood (or arterialised blood using heated hand     technique) is most appropriate for determining glucose tolerance and insulin sensitivity     since this best represents the concentrations of metabolites and hormones that peripheral     tissues are exposed to. It is essential to investigate whether venous blood (sometimes used     during an OGTT) is representative of arterialised blood during an OGTT, and under different     metabolic conditions.      The investigators want to understand whether OGTT-derived insulin sensitivity indices differ     from venous and arterialised blood; and 2) investigate whether metabolic status (i.e. rest vs     lower-limb exercise) influences the difference between forearm venous and arterialised     concentrations of glucose and insulin during an OGTT.   "
33137|NCT02852031|"     The purpose of this initiative is to improve care and outcomes for infants with HLHS by     expanding the NPC-QIC national registry to gather clinical care process, outcome, and     developmental data on infants with HLHS between diagnosis and 12 months of age, by improving     the use of standards into everyday practice across pediatric cardiology centers, and by     engaging parents as partners in the process.   "
33138|NCT02852018|"     The aim of this project is to identify common genetic polymorphisms associated with the     occurrence of rhythmic events in patients with severe cardiomyopathy.   "
33139|NCT02852005|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the     AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who     previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.   "
33140|NCT02851992|"     This is a multicenter, non-controlled, prospective study. 250 subjects (GTS standard and     lateralized) will be recruited. Study will be conducted in centers across Europe.   "
33141|NCT02851979|"     Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of     pregnancy. They are considered as an important risk factor for subsequent neuropsychological     deficiency. Current pharmacological treatments are not very effective, and have side effects     (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs     with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the     incubator's pillow might reduce the frequency of apneas. This latin square design study will     test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor     duration, intensity, and sequence using three different odors, to reduce apneic episodes     measured using 24-registration of heart and respiratory rates.   "
33142|NCT02851966|"     The investigators hypothesize that sperm production varies with time in men with no sperm in     semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to     monitor these changes. The investigators further hypothesize that TEX101 levels may be used     to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide     the highest successful rates of sperm retrieval.   "
33143|NCT02851953|"     The purpose of the present clinical investigation is to collect data regarding the safety and     effectiveness of the Aqueduct 100 device.      The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach     desired cervical dilation, and the time frame required to reach desired cervical dilation.   "
33144|NCT02851940|"     The investigators aim at prospectively comparing procedural pain, adverse events and     rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection     in patients with symptomatic hemorrhoidal disease   "
33212|NCT02851056|"     The purpose of this study is to test what effects (good and bad) a new cancer vaccine will     have on participants and their cancer, when administered before and after their autologous     hematopoietic cell transplant (HCT).      The name of the vaccine is called Dendritic Cell Survivin Vaccine (DC:AdmS). The vaccine is     made using the participant's own blood cells. The vaccine will contain a virus called an     adenovirus, similar the virus that causes the common cold. The virus has been changed so it     cannot infect humans and cause infections. The vaccine will be prepared at Moffitt Cancer     Center in the Cell Therapy Laboratory Facility.   "
33145|NCT02851927|"     Undiagnosed pleural effusion is a diagnostic dilemma especially in exudative pleural     effusions (EPE). 20-40 % are unable to be attributed to a specific diagnosis, even after     thoracentesis and closed pleural biopsy. Thoracoscopy has been demonstrated to increase the     diagnostic yield in undiagnosed EPE. The diagnostic yield of thoracoscopy in malignant and TB     pleural effusion ranges from 91% to 94% and 93% to 100%, respectively.      Rigid thoracoscopy has traditionally been the modality of choice. The recently introduced     semirigid thoracoscope provides ease of handling like a flexible bronchoscope. However, there     are concerns about the diagnostic yield of semi-rigid thoracoscopy when compared with rigid     thoracoscopy. According to the available literature, the yield of semirigid and rigid     thoracoscopy is almost similar if adequate pleural biopsy is obtained. However there are     concerns that with semi-rigid thoracoscope, there might be greater incidence of inability to     obtain adequate pleural biopsy. On the other hand, the use of conventional rigid thoracoscope     may be associated with greater procedure related pain.Mini-Thoracoscopy is a newer rigid     thoracoscopy instrument which is smaller in diameter (5.5 mm) and may allow pleural biopsy     with a smaller incision. There is scant literature on its utility. The investigators hereby     propose to undertake a randomized comparison of rigid 'mini thoracoscope' vs semi rigid     tharacoscope in undiagnosed pleural effusions.   "
33146|NCT02851914|"     Depression is seen in 9-11% of ALS patients and adequate and proper treatment is needed. In     this study, ALS patients will be screened for depression using self-reported multiple choice     questionnaire. Patients who fulfill the criteria for depression based on this screening tool     will be evaluated by psychiatrist before inclusion in the study. The investigators will also     measure quality of life and functional status by simple questionnaires. The patients will be     allocated into two treatment groups to receive either TCA or SSRI for 12 weeks. Patients will     be evaluated every 4 weeks and phone calls will be made in between the visits if needed to     assess about efficacy and any side effects. If any patient reports having suicidal thoughts     on any of these phone calls or clinic visits, he/she will be immediately sent to the ER for     appropriate management. The investigators will repeat the questionnaires in the clinic     visits, and use them in the data analysis to look for any improvement and to compare the two     medication classes used in this study. This data may be used later on to do larger studies     and help to make standard recommendations in treating depression in ALS patients.   "
33147|NCT02851901|"     This double-blind placebo-controlled design with 374 cancer patients will compare standard     varenicline treatment (12-weeks active + 12-weeks placebo) to extended varenicline treatment     (24-weeks active) for increasing week 24 & 52 biochemically-confirmed 7-day point prevalence     abstinence, assess effects of extended varenicline therapy on QOL, including varenicline side     effects, and assess changes in affect & cognitive impairment as mediators of extended     varenicline therapy effect on quit rates.   "
33149|NCT02851875|"     The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about     scleroderma. This information could be used in future research to increase the understanding     of disease mechanisms, treatments, and outcomes. This research may also help develop new     therapies, novel measures of disease assessment or identify previously unknown manifestations     of the diseases. A prospectively followed cohort is an integral component of future     translational and clinical research programs. A registry for scleroderma would allow for     information to be gleaned about patients in real-world situations in an effort to improve     the reality, generalizability and applicability of information gathered.   "
33150|NCT02851862|"     The purpose of this study is to learn more about the natural history of Late Onset GM2     Gangliosidosis (Tay-Sachs disease and Sandhoff Disease) to inform future clinical trials.   "
33151|NCT02851849|"     The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c)     during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects     with Type 2 Diabetes Mellitus (T2DM)   "
33152|NCT02851836|"     this study aims to validate a picture data set that particularly activates the attachment     process and that could be used in attachment studies.   "
33153|NCT02851823|"     The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG     laser therapy to that of scaling and root planning with hand instruments in nonsurgical     treatment of chronic periodontitis.   "
33154|NCT02851810|"     The study aims to identify specific visual scanning patterns of attachment pictures in     adolescent with different attachment style.   "
33155|NCT02851797|"     it is a randomised, double blind, parallel group, placebo controlled study. A total of 213     male ambulant subjects will be randomised 2:1 (givinostat:placebo).      Subjects will be stratified for their concomitant use of steroids in 4 strata:        1. Deflazacort daily regimen        2. Deflazacort intermittent regimen        3. Other steroids daily regimen        4. Other steroids intermittent regimen. The study duration is planned for 19 months.   "
33156|NCT02851784|"     The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of     combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in     hepatocellular carcinoma(HCC).   "
33157|NCT02851771|"     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the     diagnosis in less than two hours of pneumonia caused by known pathogens, close to the     reception of Emergency service. In this instance 30% of patients have no etiological     diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of     bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy     of pneumonia after POC tests.   "
33158|NCT02851758|"     The investigators propose a robust therapeutic intervention to ameliorate myocardial     ischemia/ reperfusion injury and significantly decrease morbidity and mortality in patients     requiring extracorporeal membrane oxygenation (ECMO), by direct injection of autogeneic     mitochondria into the ischemic myocardium.   "
33159|NCT02851745|"     The primary objective of the study is to evaluate the effect of linagliptin 5 mg daily versus     the corresponding placebo on the LV systolic function (measured by midwall shortening     analysis) in patients with T2DM and a documented baseline concentric LV geometry and LV     systolic dysfunction.   "
33162|NCT02851706|"     Background:      Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths     in the U.S. in children and adults. Little progress has been made in treating brain tumors.     Researchers want to learn more about these tumors by studying people who have them.      Objectives:      To understand brain and spinal cord tumors better and uncover areas for further research.     Also, to connect people with these tumors to doctors who can help them manage their illness     and give them new treatment options.      Eligibility:      People ages 3 and older who have been diagnosed with a tumor of the brain or spinal cord.      Design:      Participants will have an initial (baseline) visit. They will have their medical history     taken and undergo physical and neurological exams. They will have blood tests. They may have     scans (imaging studies) of the nervous system.      If participants have urine or cerebrospinal fluid collected during their regular care,     researchers may save some.      Brain tumor tissue from a prior surgery may be studied.      Genomic DNA testing will be done on samples. Results will be linked to participants medical     and/or family history.      The number of study visits at NIH will depend on the wishes of participants and their local     doctors.      Participants will take a brain tumor survey on a computer. They can take it all at once or in     6 separate sections.      Participants will answer questions about their general well-being. They will answer questions     to learn if they have symptoms of depression or anxiety.      Physicians will discuss test results with participants. They will recommend management and     treatment options.   "
33180|NCT02851472|"     The investigators seek to determine whether providing inhaled nitric oxide (iNO; a     vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of     preterm neonates during and after the subject receives a packed red blood cell transfusion     (PRBC) for anemia vs. baseline period. The investigators will observe the effect of inhaled     nitric oxide vs. placebo at these body sites to determine whether iNO will alter the     fractional tissue oxygen extraction. Treatment and control groups will be compared to each     other at equivalent epochs as will individual patients before, during and after the PRBC     transfusion.   "
33903|NCT02842021|"     To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads and     vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory     interdigital tinea pedis in subjects 12 years of age and older. The results of this study     will be utilized to perform power calculations for the Phase 3 pivotal trials.   "
33163|NCT02851693|"     The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures     such as biopsy or excision in order to analyze the structure and appearance of the fabric     pathologists. With recent advances in optical and electronic fields, considerable efforts     were produced to build high-performance optical instruments, able to transcribe the internal     structure of the skin with varying degrees of depth and variable resolution.      The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and     in real time. This area is booming and new optical instruments are created to eventually be     able to offer a reliable alternative to invasive techniques.      The optical properties of different tissues have been studied for several years by different     research groups: the coefficient of light absorption by the tissue both in vivo and in vitro,     the coefficient of light scattering or the index refractive were characterized in various     tissues that make up the skin.      Other studies have focused on melanoma detection by multispectral optical techniques, or via     the technique of optical coherence tomography (OCT) performed on lesions suspicious for     cancer, but without linking criteria between these two techniques.      However, no study to date and to our knowledge has been able to demonstrate the different     optical parameters obtained with OCT and can be directly connected to known and     histopathological parameters commonly used in the diagnosis of lesions skin. This study aims     to verify if it is possible to determine the parameters measured in OCT that would     discriminate between benign and malignant lesions.   "
33164|NCT02851680|"     In the context of screening for infectious fungal diseases in patients with malignant     haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate     the performance of an already commercialized but little used serum screening test (Fungitell®     test) and to determine its place in the management strategy for invasive aspergillosis.   "
33165|NCT02851667|"     According to the Social Welfare Department statistics, Kwun Tong has been ranked as the     highest for the reported cases of elderly abuse (12.3%), the second and fourth highest for     the reported cases of battered spouse (9.2%) and child abuse (7.9%) respectively. To     strengthen family well-being in the Kwun Tong community, the investigators adopt a     community-based participatory (CBP) approach and implement a community-based Learning     Family campaign in Kwun Tong district with the investigators collaborator, the Christian     Family Service Centre (CFSC). The campaign aims to promote family health, happiness, and     harmony (3Hs) through cultivating cooperative and self-regulated family learning culture in     Kwun Tong district.   "
33166|NCT02851654|"     Dry eye syndrome is a benign situation however its impact on patient's quality of live and on     health system is not trivial. One problem is the lack of correlation between patient's     symptoms and physical sign observed on slit lamp examination. Eye blinking is a parameter of     increased interest in this pathology particularly its frequency. To date no treatment of dry     eye syndrome has a proven impact on eye blinking frequency. However recording of blinks has     mostly been performed on short duration (3 to 5 minutes) and the distribution of intervals     between 2 blinks is not gaussian but exponential. In this study, it is proposed to use modern     eye-movement recorder to measure the blink frequency on longer duration (12 minutes) while     reading on a screen computer and during a face-to-face interview before and after treatment     of meibomian gland dysfunction responsible of moderate to severe dry eye syndrome.   "
33167|NCT02851641|"     The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a     pushed probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).      In the investigator's experience, this risk seemed to minus using a pushed probe rather than     the classical pulled-type probes.      A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold     standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the     use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic     change.   "
34290|NCT02836964|"     To evaluate the clinical success, stability, radiographic bone level changes and     peri-implants soft tissue parameter of the SLActive surface implant supporting single crowns     restorations in early loading in the mandibular first molar region.   "
33169|NCT02851615|"     The objective of this study is to determine the feasibility and acceptability of SCThrive, a     an innovative, technology-enhanced, group self-management intervention that uses a mixed     in-person and online format and supported by a tailored mHealth tool, iManage. The study will     also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in     adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that     participants in the SCThrive group will show greater BA (primary outcome) at post-treatment     than the attention control group, and that participants in the SCThrive group will continue     to show significantly greater BA at the six week follow-up compared to the attention control     group. Investigators will also explore whether SCThrive is associated with greater     improvements in self-management behaviors and quality of life (secondary outcome) compared to     attention control at the six-week follow-up assessment.   "
33170|NCT02851602|"     HDL in obese non-diabetic patients show major alterations in their function and thus their     cardio-protective effects. These alterations could be explained by the quantitative and     qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play     a major role in HDL function and probably present early modifications in obesity, even before     the onset of glycaemia deregulation.      The aim of this study is to show the presence of qualitative and quantitative modifications     of phospholipids and sphingolipids in HDL from obese patients compared with HDL from     non-obese controls.   "
33171|NCT02851589|"     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell     immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.   "
33172|NCT02851576|"     Fourteen patients will be included for infusion of adenovirus-specific T-cells generated by a     clinical grade IFN-γ based immunomagnetic isolation from a leukapheresis from their original     donor or a haploidentical donor, in case of Umbilical cord blood transplantation, in the     event of refractory ADV infection or disease.   "
33173|NCT02851563|"     The purpose of this study is to learn more about the natural history of Canavan disease   "
36715|NCT02805101|"     This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two     materials are going to be tested in sealing accidental root perforations at the bifurcation     areas. The study is going to be conducted as a randomized controlled trial.   "
33174|NCT02851550|"     Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked     to decrease enzymatic activity of LAL, responsible for intracellular accumulation of     cholesterol esters and triglycerides.      The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty     liver, hepatic fibrosis that can evolve up to cirrhosis.      LAL deficiency is responsible for significant morbidity and early mortality in children,     adolescents and adults in connection with a multi visceral disease reaching the liver,     gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or     heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for     the synthesis of the LAL.      The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto     blotting paper.      Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its     rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver     biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis     (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.      Inclusion period of 12 to 18 months (100 patients).   "
33175|NCT02851537|"     EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is     responsible. The objective of this study is to evaluate at the age of 5 years corrected     executive functions in children born very prematurely in relation to structural brain     abnormalities in magnetic resonance imaging (MRI) (technical conventional and advanced)     performed at the age of term. The current study is a project on a subset of the population of     premature EPIRMEX subjects who had an advanced technique as magnetic resonance spectroscopy     (MRS). It is a recent imaging technique for a study of the cerebral metabolism. It is based     on the detection of cerebral metabolites, and the variations of their concentration to     characterize different pathologies. In most cases, combinations of metabolites are informed     creatine + phosphocreatine (CR), glycerophosphocholine + phosphocholine (CHO) +     Nacétylaspartate Nacetylaspartylglutamate (NAA), myoinositol (INS) and lactate (LAC). In the     premature newborn, the NAA / CHO ratio increases with age in all brain regions. The LAC / NAA     ratio decreases significantly with age in the thalamus, basal ganglia, the corticospinal     tract, and parietal white matter tends to decrease elsewhere . A number of studies show that     proton spectroscopy term can predict the long-term newborn who presented an anoxic-ischemic     encephalopathy .These studies indicate that an increase in lactate and a decrease in NAA are     correlated with abnormal neurological development. And decreases in NAA / CR and / or NAA /     CHO ratios are predictive of motor abnormalities in children with anoxic encephalopathy     presented an ischemia . These decreases were also measured in the basal ganglia, occipital     cortex, and areas near the last. Few studies have explored the magnetic resonance     spectroscopy of proton-term prediction of the future of large premature.   "
33176|NCT02851524|"     Falls in the elderly population are a major public health problem because of their frequency     and their consequences, notably in terms of dependence their cost to society. In most cases,     balance disorders related to an impaired vestibular system are blamed, even though there is     no formal evidence that this is the case.      Vestibular tests in routine otoneurological practice are based on the exploration of     vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to     screen for vestibular disorders in falls.      A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as     the pathways via which vestibular afferents are transported to the subject's conscience.     Thanks to this apparatus, a stimulus of body movement will be generated, but with limited     tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone     is able to indicate to subjects their position in space. The subject will be required to     detect oscillatory movement, and then to distinguish between a vestibular stimulus and a     pulsed auditory stimulus.      The study hypothesis is that the movement stimulation generated by our prototype will be     sufficient to stimulate the vestibular system, which will manifest itself as a conscious     sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.   "
33213|NCT02851043|"     This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The     pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing     indices non-invasively. This study compares the pneuRIP to an existing Respitrace system     (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties     will be monitored with both systems.   "
33378|NCT02848885|"     This is a novel study that seeks to explore the clinical and functional imaging effects of     transcranial direct current stimulation (tDCS) on illness awareness or anosognosia in     schizophrenia, arguably the most treatment-resistant manifestation of the disorder.   "
33177|NCT02851511|"     A two-phase adaptive randomized clinical trial will examine the individual and combined     impact of pairing cognitive training with transcranial direct current stimulation (tDCS).     tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions     involved in active cognitive function and could enhance neural plasticity when paired with a     training task. We will compare changes in cognitive and brain function resulting from CT and     ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal     neuroimaging assessment of brain structure, function, and metabolic state. Functional     magnetic resonance imaging (FMRI) will be used to assess brain response during working     memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton     magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA     concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance     neurocognitive function, brain function, and functional outcomes from CT, with combined CT     and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12     months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural     plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs.     active cognitive tasks will predict individual response to tDCS.   "
33178|NCT02851498|"     This controlled weight loss trial in adults at cardiometabolic risk (elevated     triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel,     high-protein pasta and cereal to examine the physiological impact of stealth substitution of     dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and     dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone     PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM cereal)     was matched with conventional flaked cereal. Participants were instructed to follow an energy     restricted diet (-500 kcal/d) and incorporate a test food into each of three meals over a     24-hour period. The diet-induced changes in body mass and lean body mass were tracked as well     as changes in in insulin sensitivity and common blood biomarkers.   "
33179|NCT02851485|"     This is an open-label study to determine the pharmacokinetics of a new tablet formulation of     GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human     study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972     administered as tablet will also be investigated in this study. A dose of 600 mg has been     selected. The study is a phase I randomized open-label cross-over study with three single     dose treatments:      A) 600 mg GLPG1972 oral solution after overnight fast,      B) 600 mg GLPG1972 oral tablet after overnight fast,      C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.      A washout of at least 6 days between subsequent dosing days is respected so that no     measurable plasma levels or biologically significant effects are remaining. There will be     frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be     selected according to the inclusion and exclusion criteria and 2 subjects each will be     randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)   "
33181|NCT02851459|"     This study is the first phase of a trial examining decision making about vaccines. This phase     tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by     parents of young children and pre-adolescents. The participant's vaccine beliefs will be     assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A     vaccine-related message that appeals to the individual's three most or least emphasized moral     foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed     to determine the impact of the message.   "
33182|NCT02851446|"     Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure,     whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients     in the last two categories for whom it significantly prolongs life expectancy. Overall, the     treatment is well tolerated, its principal adverse effects being discomfort related to the     mask.      In certain patients, morning dyspnoea when the mask is removed has been described. This is     disabling as it limits everyday activities for at least 30 minutes, and defines deventilation     syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of     hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work     after a night of rest.      The aim of this study is to investigate the prevalence of and factors associated with     reventilation syndrome (DS) in a population of patients with ventilation whatever the reason,     in a stable state, and followed by the medical devices department of Dijon CHU, so as to     better understand the mechanisms. Patients with DS will subsequently be invited to     participate in a therapeutic trial.   "
33183|NCT02851433|"     Heart surgery is a considerable source of stress for the myocardium that must be minimized.      Troponin Ic is a reliable marker to determine the level of this myocardial stress.      Studies have shown that post-conditioning with AVH has a protective effect on the myocardium,     if the treatment is initiated at the start of the ischemia.      The aim of this study is to evaluate the protective effect on the myocardium (by measuring     troponin levels) of the association of pre-conditioning and post-conditioning with     Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve     replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with     Propofol.   "
33210|NCT02851082|"     Physical activity is lower in patients with haemophilia than in their healthy peers.     Nevertheless, exercize is recommended for those patients and supported by evidence. Until     2013, scientific and medical evidence to encourage physical activity for patients with     haemophilia were listed to increase their locomotor function, their metabolic status, their     fitness level and their well-being. In 2013, an original publication by Groen et al.     suggested that physical activity could also interact with the specific and biological     disturbance of the disease.      We propose to consider that regular endurance exercize prescription should be encouraged in     patients with haemophilia not only for a healthier lifestyle but also because it could     positively alter the specific biological blood disturbance seen in haemophilia. Nevertheless,     before planning a well powered intervention trial we need to determine the acceptability of     regular exercize and the expected value of factor Factor VIII, von Willebrand factor and von     Willebrand propeptide after an endurance training program.   "
33245|NCT02850627|"     The purpose of this study is to test the expression of microRNAs related to the syndromes     after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the     effects of Tongguan capsule, and provide the biological foundation of curative effect of     Tongguan capsule.   "
33184|NCT02851420|"     The detection of suspect lesions is based on the clinical examination of the oral cavity and     pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology     examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be     difficult. On the one hand , it is an invasive procedure, and may engender complications, and     on the other hand, certain modifications of the mucosa may be discrete, or not particularly     specific or, on the contrary, disseminated or extremely widespread.      Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to     restrict the use of biopsies to patients in whom it is really necessary 2) and to identify     the area where the biopsy should be done in cases of multiple lesions. In this context,     spectroscopy could be a promising alternative.      The investigator puts forward the hypothesis that cancerous and precancerous lesions of the     mucosa of the upper airways and digestive tract present a characteristic spectrometric     profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show     signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be     diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal     wavelengths absorbed by haemoglobin.      This pilot study will make it possible to construct an algorithm that could be used to     classify lesions of the upper airways and digestive tract as either seemingly benign or     cancerous.   "
33186|NCT02851394|"     Sternotomy, the reference approach for heart surgery, may induce profound and intense     post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.      The analgesic efficacy of continuous wound infiltration at the sternum following heart     surgery has been demonstrated.      The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.      The aim of this study is to determine whether a bolus of tramadol associated with the     continuous administration of levobupivacaine via the wound catheter could potentiate the     local anaesthetic effects, thus leading to a decreased consumption of postoperative     intravenous morphine, and a decrease in morphine-related side effects.   "
33187|NCT02851381|"     Single compassionate use subject is an 83 year old woman with a history of lymph node     positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern     Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive     chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis     in combination with gemzar. The patient is currently being treated and is tolerating gemzar.   "
33188|NCT02851368|"     This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with     indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung     nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled     camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a     fluorophore with a long-standing high safety profile.   "
33189|NCT02851355|"     Clinical follow-up survey of the Norwegian material of paediatric patients who received     therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life,     education, work, family and children, delayed effects of tumour disease and treatment,     endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.   "
33190|NCT02851342|"     In this study, 100 persons with Multiple Sclerosis and 50 matched controls will be examined     with magnetoencephalography (MEG), magnetic resonance imaging (MRI) and cognitive tests. The     primary hypothesis for the study is: Interhemispheric connectivity, determined using graph     theoretic analysis (GTA) on source-reconstructed MEG data, is a biomarker for cognitive     deterioration in MS, which has value at the individual patient level.   "
33191|NCT02851329|"     The investigators propose a non-invasive prognostic tool for TKIs resistance in patients with     stage IV EGFR-mutant non-small cell lung cancer (NSCLC) by computed tomography phenotypic     features, which can be conveniently translated to facilitate the pre-therapy individualized     management of EGFR TKIs in this disease.   "
33194|NCT02851290|"     Hypospadias is one of the most common genitourinary (GU) malformations, seen in approximately     1 of 250 male live births. Common methods of local anesthesia administration for hypospadias     surgery include caudal and dorsal penile nerve blocks. While both methods are known to be     effective with minimal risk, the effect on post-operative complications is not     well-established. The purpose of this randomized controlled trial is to evaluate if caudal     versus dorsal penile nerve block results in higher rates of post-operative complications.   "
33195|NCT02851277|"     The purpose of this study is to evaluate the safety and tolerability of ASP0892 after     intradermal or intramuscular injection in adults with peanut allergy.   "
33196|NCT02851264|"     The aims of the present study：        1. To investigate the diagnosing value of optical enhancement technology for early          esophageal squamous neoplasia.        2. To assess the detection rate of early esophageal squamous neoplasia by virtual          chromoendoscopy with optical enhancement technology .   "
33197|NCT02851251|"     These exams are vital to protect healthy neonates from blindness. The purpose of this study     is to better screen ocular disease in otherwise healthy neonates using wide-field digital     imaging system (RetCam III) in a multi-center network in China leaded by Xinhua Hospital     Affiliated to Shanghai Jiao Tong University School of Medicine. The multi-center network will     be built with the collaboration of eight hospitals from different parts of China.   "
33198|NCT02851238|"     This study aims to prove that driving pressure limited ventilation is superior in preventing     postoperative pulmonary complications to existing protective ventilation.   "
33211|NCT02851069|"     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)     has been shown to be safe and effective in randomized controlled clinical trials with strict     inclusion and exclusion criteria under well controlled conditions.      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±     RBV, used according to local label, under real world conditions in Israel in a clinical     practice patient population.   "
33260|NCT02850432|"     The aim of this study is to establish a clinically feasible simultaneous evaluation of heart     and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI     imaging markers in the evaluation of PAD and prediction of treatment outcome.   "
33199|NCT02851225|"     Currently the Toulouse University Hospital, the organization of transfusion care for patients     requiring regular transfusions is based on reading the biological results received by fax     before confirming or disproving a planned hospitalization or program a new hospital if     needed.      Remote transmission of laboratory results, replacing fax communication might facilitate the     coordination of care that results from these laboratory results and provide a better respect     of the Plan Custom Care Transfusion (PPST).      The investigators offer organization of transfusion supportive care for patients with     conditions requiring biological monitoring using the techniques of information and     communication telemedicine.      Primary objective      - Assess the feasibility of setting up an upload procedure biological results in the     treatment of transfusion supportive care.      Secondary objectives        -  Assess the evolution of the quality of life of patients during the treatment        -  Assess changes in patient satisfaction over the support        -  Assess the evolution of the satisfaction of the medical team at home and at Toulouse          University Hospital        -  Describe the programming time (hospitalization, consultations)        -  Estimate the loss of biological results        -  Assessment of the descriptive use of hospitalization, consultation and biological          examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates          for hospitalizations, NGAP rates for consultations and biology of nomenclature (NABM)          for biological tests.   "
33200|NCT02851212|"     The purpose of this study is to evaluate bioequivalence of the metformin component of the     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet     coadministered with canagliflozin in healthy fed and fasted participants.   "
33201|NCT02851199|"     Electroencephalograhy (EEG) is used as a tool for diagnosing epilepsy/convulsions.      During the recording, especially for childen who are suspected of having abbcence epilepsy     the investigators will perform an EEG recording including a provocation test of     hyperventilation in order to induce epileptic discharges.      There is no clear instruction about the position of the child during performing this     hyperventilation provocation.      Clinical observations showed that this provocation is more effective when it's performed in     the siiting position.      No study was previously performed to investigate this issue   "
33202|NCT02851186|"     Objectives:      To examine the efficacy and safety of electroacupuncture (EA) combined with auricular     acupuncture (AA) in reducing post-operative pain in patients following abdominal surgery for     gynecological diseases.      Hypothesis:      Acupuncture is effective and safe to reduce postoperative pain during the first 5 days     following surgery as compared to a sham control.      Design and strategy:      This is a randomized, placebo-controlled, subject- and assessor-blind trial. Seventy-two     subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture     treatment or sham control. Subjects in both groups will undergo standard operation procedure     and receive post-operative analgesics based on usual care.      Study instrument:      A 10-point pain Numerical Rating Scale (NRS) will be employed as a primary outcome     assessment.      Intervention:      Subjects in the treatment group will receive EA combined with AA within two hours before     operation, post-operation upon arrival to the ward and once a day for the subsequent 5 days.     Subjects in the control group will receive non-invasive sham procedure in the same schedule.      Main outcome measures:      Primary outcome: NRS pain scores will be measured upon recovery, hourly at 6 hours after     surgery, then 4-hourly until day 2, 6-hourly until day 3 and once daily until discharge.      Secondary outcome:      Morphine consumption, post-operative syndromes, quality of recovery questionnaire, SF-6D,     EQ-5D-5L and adverse events will be documented and compared between groups.      Data analysis: Pain intensity during the first 5 days will be calculated by Area Under the     Curve (AUC) of NRS pain scores. AUC between the two groups will be compared by Student's     T-test.      Expected outcome: AUC of the acupuncture group is expected to be significantly lower than     sham acupuncture group.   "
33203|NCT02851173|"     This is a mechanism-driven translational project to test the efficacy of transcranial     low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and     older adults and participants with Mild Cognitive Impairment.   "
33204|NCT02851160|"     Qualitative study on data from interviews such patients, relatives and doctors involved in     the implementation of cancer care. Framework type of method using grounded theory   "
33205|NCT02851147|"     The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit     Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and     subsequently submitting a questionnaire and hold an interview with the operator.      Of special interest for the study is to confirm whether the illumination level of SL-D301 is     enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower     than other existing Topcon digital ready slit lamps due to regulations that limit the maximum     light intensity on the human eye. The SL-D301 will be compared against the predicate device     SL-3G.   "
33206|NCT02851134|"     This study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in     individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.   "
33207|NCT02851121|"     The main goal of this study is to better understand the link between motor system (action)     and perception in variable sensorial forms by examining the time course and the dynamic of     electroencephalography (EEG) activations. To do so, differents sensimotor study protocols in     linguistics and in the fiels of emotional and spatial perception will be realised in order to     study prcisely differents links parception-action.   "
33208|NCT02851108|"     Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum     malaria treatment in African children: A randomised controlled trial      Elimination has become the goal of malaria programmes in an increasing number of endemic     countries and regions. As resistance against artemisinin compounds has recently started to     emerge in South-East Asia, there is a clear need to develop alternative malaria drug     combinations. Adding another anti-malarial with a short half-life such as methylene blue to     standard ACT could be a strategy to prevent artemisinin resistance development. Moreover,     adding a gametocytocidal drug to ACT reduces the probability of transmission of P. falciparum     parasites including drug-resistant parasites.      Objectives: The primary objective of this trial is to investigate the safety of artesunate     (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young     children with uncomplicated falciparum malaria in Burkina Faso.   "
33209|NCT02851095|"     The purpose of this study is to evaluate bioequivalence of the metformin component of the     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablets     co-administered with canagliflozin in healthy fed and fasted participants.   "
33261|NCT02850419|"     The 105-15-201 study is designed to assess the effectiveness and tolerability of the     combination of heat-activated target therapy (radiotherapy + hyperthermia +     lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse in breast cancer     patients.   "
33214|NCT02851030|"     Increasing physical activity (PA) and limiting sedentary time are important for many aspects     of a young child's wellbeing. However, young children's PA is often limited, and instead     preschoolers (3-5 year olds) spend a large portion of their day inactive. Given that more     than 7 million U.S. children younger than 5 attend center-based child care, the early care     and education (ECE) setting is an important source of PA for young children. Thus, PA     promotion efforts in ECE programs are crucial to increasing the activity levels of young     children, although few interventions exist and most have limited success.      Classroom teachers are important gatekeepers to physical activity in ECE classrooms, as they     can determine how active children are in their care. However, teachers often hesitate to     implement physical activity in their classrooms. Teachers' attitudes about PA, confidence in     modifying children's PA, and their own physical abilities can influence the amount of     activity they provide and how they interact with children to support PA. Few models exist to     enhance teachers' skill in promoting children's activity, although such an approach could     result in more sustainable outcomes. Innovative approaches to physical activity promotion are     needed, which engage teachers through training, ongoing technical assistance, and easy-to-use     resources.      This project aims to improve children's physical activity through the Move, Play, Learn!     intervention, an intervention designed to alter the behavior of classroom teachers to     increase PA in children (3-5 years old) enrolled in ECE programs through a novel, behavioral     coaching approach.      To evaluate the 10-week intervention, 32 classrooms in ECE centers will be recruited and     randomly assigned to the Move, Play, Learn! intervention or a waitlist control. Teachers in     the intervention arm will attend training workshops to learn how children's activity can be     increased using natural opportunities across the child care day and how teacher engagement     with children can impact activity outcomes. Teachers will be asked to modify typical     classroom activities to be more active, using strategies and resources (e.g., how-to videos,     pocket activity cards) and will be asked to modify their interactions with children to     support PA. Goal setting, self-monitoring, and tailored feedback will facilitate behavior     change.   "
33215|NCT02851017|"     Balance training is an important component of physical fitness, however due to the mundane     and often repetitive nature of balance training alone this is often forgotten about and as a     result people may be more susceptible to postural control instabilities. A potential solution     to the mundane aspect of balance training is the use of exergaming (interactive exercise and     gaming combined) through the use of commercial gaming systems such as the Nintendo Wii, Dance     Dance Revolution (DDR) and more recently the XBOX Kinect. The aim of the investigation was to     assess the XBOX Kinect versus traditional balance training on postural control, flow and     technology acceptance.   "
33216|NCT02851004|"     the efficacy and safety of BBI608 in combination with pembrolizumab   "
33217|NCT02850991|"     Definitive chemoradiation is the standard treatment for locally advanced esophageal cancer.     NCCN (National Comprehensive Cancer Network) recommends radiation dose of 50-50.4 Gy as the     definitive radiation dose for esophageal cancer with definitive chemo-radiation. However, as     many studies in China showed that the most common recurrence site after definitive     chemo-radiation was within the radiation region. But there have not been large randomized     clinical trials to investigate the optimal radiation dose with concurrent chemotherapy for     esophageal cancer in China. The purpose of this clinical trial is to investigate the optimal     radiation dose for thoracic esophageal squamous cell cancer with definitive concurrent     chemoradiotherapy.   "
33218|NCT02850978|"     Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with     COPD in real-world setting   "
33221|NCT02850939|"     Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all     breast cancer patients with hormone receptor-positive tumors, which represent 75% of all     breast cancer diagnoses. Long-term use of EHT reduces cancer recurrence rates and cuts the     risk of death nearly in half during the second decade after diagnosis, research shows.     Despite the proven benefits, about 33% of women who are prescribed EHT do not take their     medication as prescribed (less than 80% take their daily dosage) and are thus at higher risk     of recurrence and death.      This educational randomized controlled study will develop and pilot-test a bilingual,     culturally tailored, personalized, interactive mobile application (app) in combination with     patient navigation to promote and improve adherence to endocrine hormonal therapy (EHT) among     breast cancer patients.   "
33222|NCT02850926|"     This study will determine if protective soccer headgear reduces the incidence or severity of     Sport Related Concussion injuries (SRCs) in US adolescent (high school) soccer players. Half     the subjects will practice and play during their soccer season with soccer head gear     specifically marketed to reduce the incidence of SRCs while the other half of the subjects     will practice and play without the head gear.   "
33223|NCT02850913|"     Nodding syndrome (NS) is a devastating neurologic disorder affecting thousands of children in     Africa. A number of toxic, nutritional, infectious, para-infectious and environmental causes     have been studied but the only consistent association has been with infection by the parasite     Onchocerca volvulus. There is no specific treatment for NS and also for the adult onchocerca.     However, antibiotic depletion of the Onchocerca volvulus co-symbiotic bacteria Wolbachia with     tetracyclines such as doxycycline results in sterilisation and premature death of the adult     worm and marked reductions in dermal microfilaria density. Potentially, such therapy that     kills adult onchocerca volvulus may improve the outcome of NS if the association were true.   "
33224|NCT02850900|"     Response to psoriasis treatment is variable in large part because of poor adherence     treatments. Studies using electronic monitors have assessed adherence to topical and     injectable psoriasis treatments and to biologics, yielding critically important insights.     Adherence to oral psoriasis treatments is not as well characterized but is also critical, as     the therapeutic windows for these treatments are narrower than for other psoriasis treatment     options.      The proposed study will assess patients' adherence to oral psoriasis treatment (primarily     methotrexate) and will also collect pilot data on an intervention to improve adherence. The     primary hypothesis of the investigators study is that adherence to oral psoriasis treatment     is poor and that a reporting intervention may improve adherence to oral psoriasis treatment.     In the investigator-blinded, 6-month prospective study, patients will be randomized to     standard-of-care treatment or standard-of-care supplemented with the weekly online reporting     intervention. Adherence will be assessed using electronic monitors. This randomized trial     will permit the investigators to determine adherence to oral psoriasis treatment, assess the     relationship between adherence and psoriasis outcomes, identify factors that are associated     with adherence to oral psoriasis treatment (including physician trust, confidence in the     treatment plan, and depression), and obtain preliminary data on the impact of an     Internet-reporting measure on patients' adherence to oral psoriasis treatment   "
33262|NCT02850406|"     This study consists of two parts, Part A and Part B. Part A is a single dose PK study in     pediatric participants with Sickle Cell Disease. Part B is a multiple dose safety,     exploratory efficacy and PK study in adolescent Sickle Cell Disease participants.   "
33263|NCT02850393|"     Mental-health conditions affect million people worldwide. The economic burden of mental     illness is enormous and the economic health of both developing and developed nations will     depend on controlling the staggering growth in costs from mental disorders.     Obsessive-compulsive disorder (OCD) is a relatively common and frequent form of anxiety that     affects approximately 2-3% of the population. OCD is characterized by anxiety, obsessions     (persistent intrusive thoughts and images with highly distressing contents) and compulsions     (repetitive activity), and severely impairs the lives of those affected. Despite their     interest as effective and affordable care and rehabilitation, cognitive therapeutic profits     too little from the increasing accumulation of knowledge in neuroscience, and neuroscientists     pay too little attention to the challenges faced by clinical psychologists and psychiatrists.     To reduce this cultural gap, two teams specialized in the study and multimodal imaging of     healthy participants and clinical patients with mental health disorders, the UMR-S     INSERM-EPHE-UNICAEN U1077 unit led by Francis Eustache, and ISTS team (UMR-S 6301     CNRS-CEA-UCBN) led by Sonia Dollfus, will joint their efforts to develop an integrated     approach of the neural mechanisms at stake from basic neuroscience using state-of-art     neuroimaging techniques, to novel and ground breaking psychological intervention. Both teams     evolve at the brain imaging Cyceron center in Caen in connection with the Mental Health and     Addictology Center, offering unique opportunities for such translational research. This     project will capitalize on recent evidence showing that healthy participants can prevent     unwanted images from entering consciousness using inhibitory control and memory suppression     techniques, disrupting traces of the memories in sensory areas of the brain, and weakening     their vividness and later reentrance. OCD is characterized by aberrant and excessive visual     intrusions, usually extremely vivid, detailed, and unpleasant. These distressing images are     particularly uncontrollable and may frequently initiate compulsive rituals. In a first phase     of this proposal will use functional magnetic resonance imaging (fMRI) to develop a     neurobiological model of the cognitive computations achieved by inhibition network to     suppress memory. To achieve this goal we will develop an attentional model of healthy memory     inhibition functioning, simulating the deployment of attentional resources and the different     mental processes at stake during suppression. Using sophisticated analyzing tools of fMRI     data, we will use this model to decode and infer the representational content of the brain     inhibition network, and further refine the connectivity pathways which underlie such control.     The lack of a strong neurobiological model prevents the development of therapies which would     increase functionality of this network and optimize intervention aiming to disrupt mental     intrusions and obsessions. In a second phase, we will assess whether memory suppression may     be transferred and trained in OCD patients using images depicting their own obsessions, as a     promising avenue to reduce their symptoms on the long run. In addition, fMRI and other brain     structural acquisitions will be collected before and after cognitive training to memory     suppression, offering a unique opportunity to observe the online dysfunction of intrusion     control in OCD patients and to identify neurobiological markers predictive of training     outcome and network reconfiguration with training. A fundamental goal of motivated forgetting     involves not only to exclude unwelcome content from consciousness but also to reduce their     later emotional impact by doing so. In parallel of these two main phases, we will thus also     measure physiological markers of autonomic nervous system activity changes in response to     suppressed images to better identify the consequences of memory suppression on emotional     states, anxiety, and mental health in general.   "
33225|NCT02850887|"     The aim of this study is to determine the effect of airway management (a set of medical     procedures performed to prevent airway blockage and thus ensure an open path between a     patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography     [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and     the effect on airway complications (problems), time to biliary cannulation (access into bile     duct) and total procedure duration (length of time). Two methods are being compared and     studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks     pain) technique in which anesthetic and respiratory gases pass through a tube placed in the     trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation:     local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that     treats pain) only.   "
33226|NCT02850874|"     This single-center, prospective proof-of-concept study is designed to evaluate the surgical     outcomes and clinicopathologic results of neoadjuvant hyperthermic intraperitoneal     chemotherapy (HIPEC) in conjunction with perioperative systemic chemotherapy (SCT;     neoadjuvant and adjuvant) and pancreaticoduodenectomy (PD) in a small cohort of patients     having T1-T3 resectable pancreatic ductal adenocarcinoma (PDAC) with one or more high-risk     clinical features. The investigators hypothesize that HIPEC administered in this clinical     course will reduce postoperative peritoneal disease recurrence. The investigators also expect     that local recurrence of disease will be reduced. The primary aim of this study is to compare     2-year peritoneal disease-free survival between patients receiving the experimental therapy     (neoadjuvant HIPEC + SCT + PD) with historical controls receiving standard therapy (SCT +     PD). Secondary aims are to determine the clinical feasibility and outcomes of neoadjuvant     HIPEC for resectable PDAC using patient demographics and disease characteristic data.   "
33227|NCT02850861|"     In condylar fracture surgery, reduction is the most difficult step and the key factor which     determined the postoperative outcome. Therefore, the aim of this study is to develop a new     instrument, which the investigators call condylar redactor, to assist the surgeon to reduct     the condylar segments effectively.   "
33228|NCT02850848|"     A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test     Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an Equivalent     Dose of a Reference Drug Product (Baraclude 0.5mg Tablets) in Healthy   "
33229|NCT02850835|"     Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality     of life, daily activities and sexual function. Latina women are disproportionally affected,     with significantly higher rates of POP compared to women of other ethnicities. Decision aids     have been used to increase patient knowledge prior to physician intervention and to     facilitate informed patient participation on treatment selection. The investigators     hypothesize that the use of a video decision aid prior to initial Urogynecology specialist     evaluation of Latina women with POP in a border region university-affiliated medical clinic,     will increase patient knowledge regarding the condition, decrease decisional conflict     regarding selection among different treatment options and increase patient satisfaction with     selected treatment.   "
33230|NCT02850822|"     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient     tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess     blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome     (MDS). At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and     AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in     discussion. In this study, the safety and efficacy of chemotherapy and no chemotherapy     pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow     blast cells less than 50%) undergoing allo-HSCT are evaluated.   "
33231|NCT02850809|"     Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell     carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and     retrospectively in all centers to obtain the required number of patient followed during 5     years.   "
33232|NCT02850796|"     This study aims to test the efficacy and feasibility of an acceptance, mindfulness and     compassionate-based intervention for women with overweight and obesity without binge-eating     disorder (Kg-Free). Kg-Free intervention comprises 10 weekly group sessions plus 2 booster     fortnightly sessions (31/2months) 2h30 hours each, run in small groups at Coimbra's     University Hospital. The main goal of Kg-Free intervention is to reduce weight self-stigma     and unhealthy eating behaviours and promote quality-of-life by targeting weight-related     experiential avoidance and self-criticism patterns. The intervention focuses on fostering a     greater awareness and ability to be in contact, tolerate and accept all internal experiences     (even the unwanted ones, such as craving for food, fatigue, stigma and shame), rather than     trying to avoid, control or change them. Additionally, the intervention intents for     participant's to develop a compassionate attitude towards themselves, especially during     challenging times in order to decrease shame and self-criticism.   "
33233|NCT02850783|"     Rationale: Lymph node status is the most important factor in the selection of patients for     adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30%     stage I/II patients with negative lymph node involvement will develop distant metastases and     eventually die from colorectal carcinoma (CRC). Better detection and pathologic staging of     the lymph nodes could contribute to a better survival of colon cancer patients. This sentinel     lymph node (SLN) procedure aims to identify the first draining lymph node(s) from the primary     tumour, which have the highest risk of harbouring metastases. These SLNs can be pathological     analysed with several more sensitive histopathologic techniques like immunohistochemical     staining (IHC).      Objective: Aim of this study is to investigate if the combination of a radioactive and     fluorescent tracer can increase the sensitivity and specificity of the sentinel lymph node     mapping (SLNM) technique in colon cancer by utilizing the radioactive component for     preoperative imaging (PET/CT) of the SLNs and the near infrared (NIR) fluorescence component     for guidance to the SLNs during surgery.      Study design: Single centre pilot study Study population: Ten patients with colon cancer     (colon ascendens, colon transversum, colon descendens, sigmoid) stage Tis-T1-T2-T3, scheduled     for laparoscopic surgical resection of the tumour.      Intervention (if applicable):      The present study will be performed with the radioactive tracer 89Zr-Nanocoll and fluorescent     tracer Indocyanine Green (ICG). A colonoscopy will be performed to inject the radioactive     tracer 48 hrs before surgery. After injection, patients will undergo the first PET/CT scan. A     second PET/CT scan will be performed ± 24 hrs after tracer injection and a third scan just     before the surgical procedure; ± 48 hrs after tracer administration. During the surgical     procedure ICG diluted in saline and human albumin will be injected at the base of the tumour     by colonoscopy. The PET/CT images will be compared with respect to the total number and     location of foci and , if visible, lymphatic vessels. During surgery the fluorescent nodes     will be marked with a suture in vivo. Thereafter the PET/CT images will be used as a roadmap,     to detect SLNs which are not visible with the NIR laparoscope. These nodes will be marked     with a suture too. When all radioactive and/ or fluorescent nodes are detected, the specimen     will be resected like the conventional method. Ex vivo the specimen will be inspected for     fluorescent and/or radioactive nodes not found in vivo. All the identified nodes will be     taken out ex vivo and stored separately. The entire specimen will be submitted for pathologic     examination. All identified SLNs will be stained with hematoxylin-eosin (H&E). If the     fluorescent or radioactive SLNs are negative after routine H&E staining, they will be sliced     in multiple parts and examined with H&E staining and immunohistochemistry with the specific     marker CAM5.2. Finally, the pathologist uses palpation to identify the remaining     non-fluorescent and/ or radioactive lymph nodes. Nodes found by palpation will be screened     for fluorescent and/ or radioactive activity too.      The amount of tumour tissue in positive nodes will be evaluated with the Q-prodit; an     interactive video morphometry system (Leica, Cambridge, UK).      Main study parameters/endpoints: Main study parameter is the identification rate of SLN     mapping with preoperative PET/CT scans combined with intraoperative near-infrared (NIR)     fluorescence imaging in patients with colon carcinoma. Thereby biodistribution and kinetics     of 89Zr-Nanocoll have to be considered as primary study parameter. Secondary endpoints are     the number and localization of the SLNs and optimal tracer volume.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: All participating patients will receive conventional resection of the tumour and     follow-up according to normal standards in our hospital. The main goal of this study is to     optimize the SLN mapping technique in colon cancer. If the investigators are able to identify     the true SLN this could lead to better staging and survival of patients with this type of     cancer. . Because of the colonoscopy ± 48 hrs before surgery, patients stay in the hospital     will be prolonged with one day. The additional risks of exposure to radiation for     participating patients are calculated and can be considered as negligible.   "
33234|NCT02850770|"     The objective of this study was to investigate the feasibility, perceived usefulness, and     potential effectiveness of a short text or voice message intervention to activate 1) physical     activity behavior change among low-income, urban, Latino patients in diabetes management and     2) supportive behaviors by family members or close friends.   "
33235|NCT02850757|"     This study will compare the efficacy of modified William's airway versus U shaped Guedl's     airway in assistant of fiberoptic bronchoscope during endotracheal intubation   "
33236|NCT02850744|"     PQR309 is an oral, dual pan-PI3K (phosphatidylinositol 3-kinase phosphoinositide 3-kinase)     and mTOR (mammilian target of rapamycin) inhibitor that penetrates the blood-brain barrier at     pharmacodynamically active concentrations. This study plans to evaluate PQR309 in treatment     of patients with first progression of glioblastoma.   "
33295|NCT02849977|"     The purpose of this screening study is to identify people who have a rare genetic cause of     obesity - specifically three genetic variants (a change in the DNA structure) of the POMC,     PCSK1 and LepR genes that are currently known to result in obesity.      This screening study will not include any investigational drugs. You will be asked to provide     a DNA sample and answer some questions about your medical history and hunger.   "
33237|NCT02850731|"     Highly diversified programs of physical activity in older people have shown their     effectiveness in terms of improving functional capacities. Only one of these programs, to     date, has used a motorized platform. The motorized platform allows the use of sensorimotor     programs adapted to this population. Thus, for the user, a combination of motor and sensory     capacities necessary to actively control different positions as well as reactions to maintain     balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy     and the fight against losing independence.      Demonstration of the effectiveness of this type of equipment would propose a new modality of     physical activity adapted to this population. Use of this new equipment could allow the     possibility of standardizing this activity, whilst continuing to individualize physical     activity programs.      Two phases for each group (Intervention/Control):      Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or     an adapted physical activity program (Control group) under supervision of a therapist who     will adapt the program according to the progress of the patient, following a standardized     procedure (exercises: postural/balance training, strength training for the legs/trunk and     coordination and endurance activities) Phase 2 (week 6 - month 6): Physical activity program     at home for both groups, performed independently.      Blinded evaluations will be performed at 6 weeks and at 6 months for each group.      The investigators hypothesis is that the use of the motorized platform will allow superior     physical performance compared to a traditional physical activity program.   "
33238|NCT02850718|"     A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test     sublingual sildenafil wafer.   "
33239|NCT02850705|"     Devic's neuromyelitis optica (NMO) is rare. Epidemiological and demographic data are poor,     based mainly on monocentric cohorts. Moreover, NMO might be difficult to distinguish from     multiple sclerosis and begin with atypical or incomplete clinical presentations. Therefore,     NMO is still underdiagnosed. The constitution of a nationwide and prospective cohort,     including not only NMO but also clinical syndromes suggestive of a first episode     (DNMO-spectrum disorders (SDs)), should allow to gather a critical mass of cases and answer     questions that could not have been addressed at the level of a single centre.      Objectives: The main objective is to describe the clinical, radiological and biological     features of NMO spectrum disorder (NMO, isolated longitudinally extensive transverse myelitis     (LETM), relapsing or not; isolated atypical optic neuritis (ON)) and their evolution. The     second aim is to create a biobank dedicated to NMO (serum, whole blood for RNA and DNA     extraction, cerebrospinal fluid), to promote translational research in the field. Methods:     NOMADMUS is a prospective, multicentre, observational study of patients NMOSD and related     disorder in France. Prevalent cases are included retrospectively and then followed     prospectively. Incident cases are included from disease onset and followed prospectively. A     minimal set of data has been defined and synthesized on specific paper forms derived from the     European database for multiple sclerosis (EDMUS) forms. Patients are systematically tested     regarding their AQP4-IgG and MOG-IgG status. All the data are centralised in a EDMUS-derived     database in Lyon, the EDEN software. All cases are validated and classified by an expert     committee.   "
33267|NCT02850341|"     The purpose of this study is to determine if the use of pedometers can help depressive     inpatients in psychiatric clinics to increase their level of physical activity. Therefore     patients are given a pedometer and instructions how to raise their level of daily steps.     Intervention group is compared with a control group that is receiving treatment-as-usual. The     intervention is hypothesized to increase number of daily steps and have positive effects on     mood, depression and anxiety.   "
33240|NCT02850692|"     Cystic fibrosis can affect organs other than the lungs. Liver disease affects about 30% of     patients: its main manifestation is the development of portal hypertension (PHT). The     pathophysiology of this comorbidity is still poorly understood. It was previously considered     secondary to the formation of biliary cirrhosis but another hypothesis would be that of a     primitive pathology of venous vessels may cause the gradual emergence of portal hypertension     without cirrhosis. Evidence indiscutly suggest that cystic fibrosis is associated with a     specific endothelial dysfunction, especially as the CFTR (Cystic Fibrosis Transmembrane     conductance Regulator) protein is expressed on the surface of endothelial cells. The     investigators hypothesize that liver disease related to PHT−associated cystic fibrosis is     associated with systemic endothelial dysfunction.      The aim is:      To demonstrate a systemic endothelial dysfunction in patients with cystic fibrosis when     associated with PHT.      To study the correlations between measures of systemic endothelial function and serum markers     of endothelial dysfunction and between measures of liver stiffness and systemic endothelial     function.   "
33241|NCT02850679|"     This is a retrospective multi-center patient cohort study investigating patients with     persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify     clinical predictors for ineffective ECV to improve management quality of persistent AF.   "
33242|NCT02850666|"     This is a one-group, pre-post feasibility study of an intensive, interdisciplinary (theatre,     Occupational Therapy (OT), and Speech Language Pathology (SLP)) intervention targeted at     social skill development in children, aged 3-4. The intervention uses process drama modified     with OT and SLP techniques and using typically developing peer models. Feasibility outcomes     are recruitment rates, retention rates, daily program records of ease of implementing     program, and record of modifications needed. Child primary outcomes are Social Skills     Improvement Scale (SSIS), Theory of Mind (T0M) Battery and Inventory, Structured Play     Assessment (SPA), and Communication and Symbolic Behavior Scales (CSBS) scores within 4 weeks     of program end. Secondary outcomes are brain activity in frontal lobe and temporal/parietal     areas measured by high density EEG within 4 weeks of program end, parental interview at 3     months related to child's social skills, and observational data on social skills during the     program.   "
33243|NCT02850653|"     Endophthalmitis is a serious eye infection of exogenous origin (post-operational,     post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic     emergency.      Each patient suffering from endophthalmitis must have immediately an ocular sampling, an     intra ocular injection of antibiotics and a systemic antibiotic cover.      The etiological treatment will be adapted according to the infectious agent.   "
33244|NCT02850640|"     Cost and Medical Care of Patients with Advanced Serious Illness in Singapore (COMPASS),is a     cohort study which aims to capture health care utilization, cost, and quality of life     indicators of patients with advanced cancer and their primary caregivers.   "
33246|NCT02850614|"     Juniors and seniors will be recruited to participate in the study, which will begin in the     fall 2016 and run through May. The intervention will be a randomized-controlled trial, where     students are randomized to either a control or incentive condition. Physical activity will be     automatically tracked throughout the study period using FitBit activity trackers wirelessly     linked to the gaming application on students' Chromebooks or mobile phones. Students who     achieve 30 minutes of MVPA during the school day and/or 60 minutes of MVPA over the entire     day will receive in-game rewards moving them up leaderboards in the game, providing them with     more game points, or allowing them access to more game elements. Baseline outcome measures     will be collected at the beginning of the school year in the fall, and post-intervention     outcome measures will be collected in May.   "
33247|NCT02850601|"     The objective of this single center, 4-week, open label randomized, phase II study is to     evaluate and characterize the tolerability and clinical effectiveness of dexamethasone     0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen     planus.   "
33248|NCT02850588|"     The VQI TCAR Surveillance Project is designed to monitor the safety and effectiveness of     stents placed directly into the carotid artery while reversing blood flow within the carotid     artery to reduce stroke risk. It will compare this less-invasive surgical procedure with     standard carotid endarterectomy in centers that participate in the Society for Vascular     Surgery Vascular Quality Initiative.   "
33249|NCT02850575|"     This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough     IMAGIKA technology.   "
33250|NCT02850562|"     The objective of this study is to test the effects of a healthy diet & walking (Controls)     compared to a healthy diet, walking, and balance/strength exercises (Intervention) on muscle     density in two populations: elderly individuals and obese individuals. The intervention will     be 3 months in length. During this time, both Control and Intervention groups will meet one     time each week for educational sessions on healthy diet strategies and to participate in a     group walk for the Control group or group exercises for the Intervention group. The Control     group will be asked to walk on their own an additional 4 times per week (5 times total) for     at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month     time point. The Intervention group will walk two times per week using the same criteria as     above, and in addition will do balance/strength exercises on a total of three days per week.     Measurements will be made at baseline, at intervention completion (3 months) and at a     follow-up (6 months -3 months after completion of the intervention). At 3 months, the control     group will be invited to add the balance/strength exercises.      The hypotheses are that adding balance & strength exercises to a healthy diet plan will     increase muscle density (decrease fat infiltration) and improve muscle function in the     elderly and in the obese populations. Increases in muscle density are expected to show     greater improvements in muscle function in the elderly population, while it is speculated     that greater improvements in metabolic measures will show in the obese population.     Participants in the intervention group will have a greater reduction in falls and less     hospital, ER & clinic visits compared to the control group, but both groups will have an     improved quality of life, positive changes in eating behaviors, and decreased perceived     stress.   "
33251|NCT02850549|"     The purpose of this study was to assess if pain and function in patients with neck pain is     less when physical therapists use a classification system.   "
33252|NCT02850536|"     This is an open label, fixed dose, phase Ib trial of anti-CEA CAR-T cell infusions delivered     via the hepatic artery using the Surefire Infusion System (SIS) for patients with     CEA-expressing liver metastases.   "
33286|NCT02850094|"     The investigators propose a 24 week program to provide proof-of-principle evidence that     financial incentives stimulate Brigham and Women's Hospital (BWH) employees to be more     physically active.   "
33253|NCT02850523|"     Anxiety Disorders (AD) are a serious mental health concern, affecting up to 15% of perinatal     women. AD often coexists with depression and result in high distress and an impaired ability     for new mothers to take care of themselves and their babies. In spite of the high prevalence     of AD during pregnancy and postpartum, research and clinical attention in this area is     lacking and no know empirically supported psychological treatments exist. Further, since many     perinatal women are unable to choose not to take medication for their mental health symptoms,     establishing an effective non-pharmacological alternative is imperative.     Cognitive-behavioural therapy (CBT) is a well-established psychological treatment for mental     health disorders, with noted moderate to large effect sized (.5-1.3). The investigators have     recently developed a novel CBT treatment program for perinatal women with AD and ran an     initial pilot study thereafter. A significant reduction in symptoms of anxiety and depression     was found, along with reported high levels of treatment satisfaction. The purpose of the     current study is to confirm the effectiveness of this treatment using a larger sample in the     form of a rigorous randomized controlled trial (RCT).   "
33254|NCT02850510|"     Aim of study:      To evaluate the effects of the shortened version of the Incredible Years (IY) Basic     programme, the study which the parents were recruited to. A randomising experimental control     between-group design was used with pre- and post-intervention measurements, and a one-year,     four-year and ten-year follow-up. Children and families were randomized to either the     shortened basic version (n = 89), or the control group (n = 97).   "
33255|NCT02850497|"     Aim of this study is to compare at 6 months follow-up, endothelization and malapposition,     evaluated by means of optical coherence tomography, in terms of number of struts not     endothelized or malapposed, after the implantation of three new generation stent: Cre8,     Biomatrix and Xience.   "
33256|NCT02850484|"     The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA     Inhaler and Symbicort 160/4.5μg in healthy volunteers with charcoal block.   "
33257|NCT02850471|"     TEAS might protect against postoperative pulmonary such as ischemia-reperfusion injury (IRI)     and atelectasis. We tested the hypothesis that transcutaneous electrical acupoint stimulation     protects against postoperative pulmonary complications in patients who are receiving     mechanical ventilation during general anesthesia for gynecologic laparoscopic surgery.   "
33258|NCT02850458|"     The purpose of this study is to evaluate the clinical results of implant-retained mandibular     overdentures in edentulous patients.   "
33259|NCT02850445|"     Regular psychosocial intervention combined with antipsychotic drugs, compared with usual     medication alone treatments, can reduce psychiatric symptoms and improve quality of life in     patients with schizophrenia. However, it's expensive, time-consuming, and sometimes     inconvenient for patients and their family members in developing areas where the number of     well-trained therapist remains limited in local psychiatric settings. The investigators aimed     to establish an efficient model of integrated treatment (IT) for patients with schizophrenia.     The procedure contains two stages: a centralized treatment during hospitalization and the     following consolidation treatments with long intervals.   "
44981|NCT02696889|"     The ROSE study is designed to determine the efficacy of bone marrow derived stem cell therapy     on ovarian function recovery in subjects with idiopathic and other types of premature ovarian     failure (POF)   "
33264|NCT02850380|"     The purpose of the study is to investigate spatial orientation in weightlessness as it     manifests not in perception but rather in motor performance by direction and reaction time of     flip switch.      Hypotheses are that flip switch:        1. will be biased towards visual allocentric cues when those are available;        2. will be biased towards the egocentric reference when tactile cues are added;        3. will be dominated by egocentric cues when visual cues are not available;        4. will be delayed and more variable when confirmatory gravitational cues are absent;        5. will be faster and more reliable in absence of conflicting gravitational cues, and even          more so when tactile cues are added;        6. The difference will be more pronounce when tested under Dual-task condition   "
33265|NCT02850367|"     NO is an ubiquitous molecule contributing to many physiological functions such as     vasodilation, immune and oxidative stress responses. NO production can be supplemented either     by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by providing     nitrate which can lead to NO. In the present project the investigators evaluate the effect of     various acute and chronic oral NO precursors supplementation on exercise performance and     responses in healthy young and older subjects.   "
33266|NCT02850354|"     The regulation of the cardiovascular respiratory system after changing environmental     conditions or changes in work rates are essential for cognitive as well as physical     functioning. For decades, it is known that high level of headward acceleration (+Gz) impairs     cardiovascular function that may cause loss of consciousness. Some anti-g maneuvers, such     as muscle contraction of the lower extremities and buttocks or intermittent exhalation on     exertion (i.e., exhalation against a closed airway) have been proved to increase tolerance to     high +Gz.      Main objective of this experiment is to investigate the effects of anti-g maneuvers on     cardiovascular and respiratory tolerance to the push-pull-effect.      Cardiovascular and respiratory functions will be evaluated with the following parameters:     heart rate, stroke volume, cardiac output, blood pressure, oxygen uptake, carbon dioxide     output, ventilation, breathing frequency, body core temperature.      Electromyography (EMG) will not be a judgment criteria but will be used to check the quality     of 'muscle contraction' anti-g maneuver.      The main hypothesis is that anti-g maneuvers will increase cardiovascular and respiratory     tolerance to the push-pull effect, especially when they are combined.   "
33268|NCT02850328|"     The aim of this study is to evaluate the applicability of high-load resistance training as a     countermeasure for long term space flights, the current project has two scientific goals.      The main objective is to perform a deeper examination of muscle function and MVC in     weightlessness (parabolic flight).      The secondary objective is to gather further insight into the underlying mechanisms and     structures based on investigations targeting the neuromuscular and musculotendinous systems     and their interaction.   "
33269|NCT02850315|"     The pharmacoinvasive approach after thrombolysis is the standard treatment of myocardial     infarction when deadlines are too long for primary angioplasty. Coronary angioplasty is then     carried out within 3 to 24 hours following thrombolysis. The adjuvant antiplatelet therapy of     thrombolysis combines aspirin with clopidogrel (75 or 300 mg depending on age). These     clopidogrel doses are associated with a very low anti-platelet aggregation response within 24     hours following administration. However, the antiplatelet agregation that inhibits the     progression of intracoronary thrombus must be optimal at the time of angioplasty to reduce     the risk of thrombotic events. Intracoronary thrombus residual angiographic post-thrombolysis     was associated with impaired myocardial reperfusion but coronary angiography has a very low     sensitivity for detecting the thrombus. The optical coherence tomography (OCT) is currently     the method of choice to visualize and quantify the intracoronary thrombus. It is used     routinely in the presence of a thrombus to correctly estimate the size of the artery and for     the evaluation of good stent apposition.      The thrombectomy at the time of angioplasty improves myocardial reperfusion, particularly in     case of major thrombotic mass. Intracoronary thrombus residual post-thrombolysis could be a     marker for the quality of reperfusion itself correlated to the quality of the antiplatelet     post-thrombolysis.      The investigators therefore hypothesize that the systematic use of the OCT before elective     angioplasty (within 3 to 24 hours) after successful thrombolysis could be used to guide the     use of thrombectomy and adequate stenting and thus improve myocardial reperfusion. Our study     will also correlate the importance of the residual thrombus before angioplasty myocardial     reperfusion one hand and to the inhibition of platelet activity observed other.   "
33270|NCT02850302|"     Breast cancer is a major public health problem. In France, it is the leading cause of cancer     death in women. According to the National Cancer Institute (INCA), approximately 49,000 new     cases were diagnosed in 2012 in France.      It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior,     biological and prognosis differ. Amongst these entities, the breast cancer triple negative     (TN) is defined by the absence of expression of estrogen receptor and progesterone and the     absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and     occurs more frequently in young women. This is a very proliferative tumor phenotype with     metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified     molecular target, no targeted therapy has today shown benefit in terms of survival compared     to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of this     tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose (FDG) is     a molecular imaging test that can identify from the first or second neoadjuvant chemotherapy     treatment non-responder patients to treatment with low probability of pathologic complete     response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET examinations should be     performed; a) a pretreatment PET b) a control PET after one or two treatments. The objective     of this pilot, single-center, prospective study is a preliminary identification of recurrent     genomic alterations among triple-negative tumors with early chemoresistance, identified by     PET in the first cycle of neoadjuvant therapy.   "
33271|NCT02850289|"     This multi-center, observational study will examine the clinical use and outcomes of     pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in     participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12,     24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for     participants with an HCV genotype other than 2 or 3. Quality of life data will be collected     at baseline, and at each follow-up visit.   "
33316|NCT02849691|"     Dipeptidyl-peptidase-4 (DPP4) is an important regulator of incretins and inflammation, and     participates in the pathophysiological process of acute myocardial infarction (AMI). However     clinical data of DPP4a in AMI patients is sparse. This study was to investigate the role of     plasma DPP4 activity (DPP4a) in patients with ST-segment elevation myocardial infarction     (STEMI) treated with percutaneous coronary intervention (PCI). This was a analysis of     consecutive patients conducted at a tertiary referral center from January 2014 to October     2015. The investigators included 747 STEMI-patients, treated with PCI from January 2013 to     October 2015. Blood samples were collected immediately at admission. The patients were     divided into four groups according to DPP4a quartile.   "
33272|NCT02850276|"     The purpose of this study is to explore a possible link between the autonomic nervous system     and immune function in patients with HIV. Sometimes HIV can cause these nerves to function     abnormally, this is called HIV-associated autonomic neuropathy (HIV-AN). HIV-AN is a     condition that is different from person to person. In some people it causes no symptoms and     is not harmful, in others it may cause symptoms such as dizziness or lightheadedness, nausea,     vomiting, diarrhea, constipation, or problems urinating. Most people with HIV-AN don't know     that they have it. One of the important nerves in the autonomic nervous system is the vagus     nerve. Abnormal function of the vagus nerve may cause stomach and intestinal slowing, which     could lead to an overgrowth of bacteria. The body senses these bacteria and tries to fight     them, leading to inflammation.      In this study the researchers will test whether abnormal function of the vagus nerve in HIV     is associated with stomach slowing and overgrowth of bacteria, and if a drug called     pyridostigmine can help.   "
33273|NCT02850263|"     Intravitreal aflibercept has been approved for the treatment of visual impairments due to     diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.      The main objectives of this observational cohort field study are to evaluate effectiveness of     intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti     vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine     clinical practice in the United Kingdom.   "
33274|NCT02850250|"     -  To evaluate plasma concentrations of Cefuroxime in this patient population        -  To determine if certain pathophysiological and/or iatrogenic conditions alter the          pharmacokinetics in this patient group.        -  To develop a rational physiological population pharmacokinetic model that describes          plasma concentrations of medications in these patients.   "
33275|NCT02850237|"     Cerebral saturation will be measured pre-hospital during an out-of hospital cardiac arrest     with O3TM regional oximetry for Root® (Masimo®). The O3TM regional oximetry for Root®     (Masimo®) is a device that can measure not only cerebral saturation but also end-tidal CO2     (capnography). Currently, end-tidal CO2 is already measured during Advanced Life Support     following most recent European Resuscitation Guidelines but with another monitor. Until now     it is the only parameter which may predict return of spontaneous circulation. Because of     this, researchers want to measure both with the same device, which gives the investigators     the opportunity and advantage to compare end-tidal CO2 and cerebral saturation very     precisely. In this manner researchers want to investigate the predictive value of cerebral     saturation and compare it end-tidal CO2.   "
33354|NCT02849197|"     Comparison of limited excision-primary closure, Limberg, and modified Limberg flap techniques     for the surgical treatment of pilonidal sinus disease, each performed by a separate surgeon,     in terms of postoperative outcomes and recurrence rates.   "
33355|NCT02849184|"     The purpose of this study is to compare the effectiveness and safety of suvorexant versus     placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.   "
33276|NCT02850224|"     In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines     on cardiovascular health and risk reduction in children; among these guidelines were     screening recommendations for obesity and obesity-related conditions. Following publication     of this report there was a call for caution and for increased patient (parent, child) input     on implementing these guidelines. There are limited current studies evaluating     patient-centered outcomes (PCO) in the well-child setting, however, given the childhood     obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI ranks     first among 22 cities with data for the prevalence of overweight and obese youth (39.7%),     making Henry Ford Health System, which is located in Detroit, MI, an ideal setting to study     childhood obesity related research questions.   "
33277|NCT02850211|"     Selective cyclooxygenase (COX)-2 inhibitors are commonly used analgesics that provide similar     analgesia but reduced adverse effects compared to other analgesics. However, few studies have     been conducted on postoperative pain and tendon-to-bone healing. Here, the investigators     investigated the effect of a selective COX-2 inhibitor on analgesia and tendon-to-bone     healing following arthroscopic rotator cuff repair.   "
33278|NCT02850198|"     This research is primary to compare effectiveness of scalp electroacupuncture and scalp     acupuncture on motor function of the upper limb(UL) in convalescence phase of ischemic     stroke. The clinical research is a randomized controlled trial (RCT),consisting of two arms     of scalp electroacupuncture group and sham sclp electroacupuncture group to value difference     of upper limb function after 4 weeks. The result indicates that scalp electroacupuncture is     more sufficient to alter function. The purpose is to value effectiveness of scalp     electroacupuncture on motor function of the upper limb in convalescence phase of ischemic     stroke.   "
33279|NCT02850185|"     The purpose for this study is to determine safety and effectiveness of the oxyhydrogen     generator with nebulizer through an adjuvant therapy for the severe COPD patients in the     stable phase.   "
33280|NCT02850172|"     The purpose of this stratified randomized controlled trial (RCT) is to test the effects of     Walk, Eat, & Breathe on preserving patients' nutritional status, functional walking capacity,     pulmonary function, and emotional well-being during the CCRT and surgery course.Additionally,     effects to reduce treatment-related complications and length of hospital stay for     esophagectomy will be evaluated between experimental and control groups.   "
33281|NCT02850159|"     The purpose of this study is to investigate the effect of dual-mode non-invasive brain     stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS)     over the primary motor cortex of the lower leg and anodal transcranial direct current     stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in     patients with Parkinson's disease (PD) with freezing of gait (FOG).   "
33331|NCT02849496|"     This randomized phase II trial studies how well veliparib and atezolizumab work either alone     or in combination in treating patients with stage III-IV triple negative breast cancer.     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor     cells to grow and spread. It is not known whether giving veliparib and atezolizumab either     alone or in combination would work better in patients with triple negative breast cancer.   "
33282|NCT02850146|"     Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled in     the LEARN-Tau study. The study designed to evaluate the imaging characteristics of     18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database of     18F-AV-1451.      The study will run in parallel to the LEARN study. In this study, participants will undergo     up three (3) 18F-AV-1451 PET scans over a 3 year period. Imaging visits will occur at the     start, middle and end of the participant's participation in the LEARN study (corresponding to     LEARN Visit 1, between Visit 4 and 6, and Visit 8).      The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain over     time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of older     individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451 and     any side effects that might be associated with it.      Site investigators, participants, and study partners will not be informed of the results of     the 18F-AV-1451 PET scan results as they relate to the study; however, any findings that may     be of potential medical concern will be provided for appropriate follow-up.   "
33283|NCT02850133|"     Background:      Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases     compared to the healthy population. Aerobic exercise training is one of the recommended     treatments. However, literature regarding the effect of aerobic training on patients with SCI     is scarce. This study evaluated changes in parameters of exercise physiology and serum     myokines immediately after exercise and after a training program among patients with SCI.      Method:      Male patients with SCI and age- and sex-matched healthy individuals were recruited.     Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise     and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise     training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology     parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin)     concentrations were measured pre- and post-exercise in both groups, and were repeated in     patients with SCI post-training.   "
33284|NCT02850120|"     Complications from mesh procedures (i.e. insertion of tension-free vaginal tapes (TVT),     trans-obturator tapes (TOT) and suprapubic slings (SS)) used during surgical treatment of     stress urinary incontinence have caused major concern around the world.      The investigators aim to conduct a retrospective cohort study using administrative inpatient     data from the Hospital Episode Statistics (HES) database to determine the complications of     all first-time surgical mesh procedures in the treatment of stress urinary incontinence (SUI)     in women treated in a National Health Service (NHS) hospital in England who were discharged     from hospital between 1st April 2007 and 31st March 2015.      The primary outcome measure is the number and types of complications (occurring     peri-procedurally, within 30 days of the mesh procedure and those occurring during     follow-up). Additional outcomes recorded include: the numbers and types of mesh procedures,     including those with potentially confounding concomitant procedures.   "
33285|NCT02850107|"     This study is designed to collect information during a procedure that is routine care for     treating a blockage in a blood vessel in the upper part of the participant's leg. This study     is for data collection reasons to help doctors gain better understanding of the treatment of     disease in the blood vessels of the legs. You will be treated with two devices that are     routine, or standard of care, for your doctor to treat blockages in the blood vessel of the     leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood     vessel. Data will be collected to assess what length of time the blood vessel will be     prevented from re-narrowing through twenty-four (24) months after the procedure.   "
33287|NCT02850081|"     The investigators hypothesize that pre-operative statin use is neuroprotective at maximal     doses. The goals are to determine the safety, feasibility, and efficacy of maximizing statin     doses for two weeks (12-18 days) prior to CEA using change in performance on a battery     neuropsychometric tests as outcome measure. Study will recruit patients based on their     preexisting statin regimen.      The investigators hypothesize that in asymptomatic CEA patients: 1) Pre-operative statin use     is neuroprotective against early cognitive dysfunction (eCD) and lowers the risk of early     mortality. 2) Maximal doses may be essential in achieving optimal neuroprotection against     eCD.   "
33288|NCT02850068|"     This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce     the severity of pain and disability caused by knee osteoarthritis.   "
33289|NCT02850055|"     Tinnitus is one of the most prevalent symptoms that causes more disability in patients with     temporomandibular disorder (TMD). The present study postulates a possible link between     temporomandibular joint (TMJ) and inner ear based on their anatomical, biomechanical and     physiological relationship, proposing a physiotherapy treatment for the temporomandibular     joint to improve tinnitus.      The aim of the study is to evaluate the effectiveness of adding specific manual therapy to a     multimodal physiotherapy treatment in patients with tinnitus and temporomandibular disorder.   "
33290|NCT02850042|"     This pilot study was designed to compare the effects of modified constraint-Induced therapy     and occupation-based intervention to increase functional motor recovery in stroke   "
33291|NCT02850029|"     This is an international observational cohort study on current aminoglycoside practices in     intensive care units. Clinical and demographic data, dosing and therapeutic drug monitoring     data will be collected during the first week of aminoglycoside (tobramycin, amikacin or     gentamicin) administration in different countries over a year. A minimum of ten consecutive     patients will be enrolled at each site.   "
33292|NCT02850016|"     The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin     alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals     during an analytical interruption of ART.   "
33293|NCT02850003|"     Study designed to assess the safety and plasma PK of tretinoin and its metabolites from     topically applied IDP-120 gel.   "
33294|NCT02849990|"     This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix,     and indomethacin work in treating patients with prostate cancer that has spread from where it     started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of     tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix,     and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes     and/or blocking the use of androgen by the tumor cells.   "
33296|NCT02849964|"     The REIN registry highlights significant disparities in the incidence of end-stage renal     disease (ESRD) between regions, especially in the North East of France. According to the     literature, the incidence of ESRD in an area could be related to contextual factors     influencing the needs for dialysis or transplantation (age structure, prevalence of risk     factors, socioeconomic and morbidity levels), as well as to primary and secondary care     provision (general practitioners and nephrologists) and to practice patterns in nephrology.      The aims of this project are the following:        1. to compare the incidence of renal replacement therapy (dialysis or preemptive          transplantation) for ESRD between the départements and the cantons belonging to the          5 regions of Eastern France (Alsace, Lorraine, Champagne-Ardenne, Bourgogne and          Franche-Comté), while taking into account differences in population sizes and spatial          patterns of the data,        2. to analyse the relations between incidence disparities and socioeconomic environment,          geographic accessibility to primary and secondary care and medical practice patterns,          after adjusting for morbidity and mortality rates (incidence of diabetes, cardiovascular          mortality).      This project will enable a better understanding of the mechanisms involved in the spatial     variations of ESRD incidence, while disentangling effects related to the need from effects     related to service supply in different socio-economic contexts. It will be possible to     identify a lack of equity in access to renal replacement therapy if, after adjusting for need     indicators, there were variations of incidence of ESRD related to availability of service or     to socioeconomic context. Highlighting such effects would lead to search for corrective     measures in collaboration with the different stakeholders.   "
33297|NCT02849951|"     The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on     treatment is effective and safe for the induction of remission in ulcerative colitis patients     refractory to standard treatment with mesalamine   "
33298|NCT02849938|"     The specific aims of the study are to:        1. Assess the feasibility of a TytoCare telehealth device with remote audio/video          connection for evaluation of children with medical complexity in the home environment.        2. Evaluate the usability of a TytoCare telehealth device in transmitting real time images          (otoscope, oropharyngeal exam, camera), temperature, and sound (stethoscope for heart          and breath sounds)        3. Compare the impact of the TytoCare telehealth device versus traditional telephone          assessment on patient management and user satisfaction   "
33299|NCT02849925|"     This study aimed to test whether sealing microcavitated ICDAS 3 carious lesions in permanent     molars may be arrested by sealing using two different types of materials; a glass ionomer and     a resin sealant. A Randomized controlled clinical trial was designed. Children between 6 and     12 years old were recruited and a total of 150 ICDAS 3 lesions in first permanent molars were     allocated to one of the two arms of the study. Clinical and radiographic lesion progression     were the main outcome. Integrity of the material and retention were secondary outcomes. A     follow up period of 24 months with check-ups at 6 and 12 months was considered.   "
33413|NCT02848417|"     The investigator proposes to perform a phase I/II study comparing two nutraceuticals and     placebo that target mediators identified in the investigator's prior dynamic modeling study     of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment     and on therapy to assess the modeling and the impact of the interventions on the homeostatic     networks that have identified, with an added focus on the glutathione/redox system.   "
33414|NCT02848404|"     The purpose of this study is to examine therapeutic efficacy of catergorical language fluency     smartphone game apllication in mild congnitive imapirment and mild Alzheimer's dementia.   "
33415|NCT02848391|"     Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in     normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to     evaluate the impact of a flight simulation on walking endurance in these patients.   "
33300|NCT02849912|"     Non Hodgkin lymphoma (NHL) is the 5th cancer in France. Advances in NHL therapy have resulted     in improved cure rates with a 5 year relative survival rate estimated at 55% and a 5-year     prevalence estimate of 27,750 cases. Since 2000, the addition of anti-CD20 antibody to the     standard treatment regimen composed of cyclophosphamide, doxorubicin, vincristine, and     prednisone (CHOP) led for the first time to decline of the specific mortality.      After treatment, patients with NHL experienced elevated risks for therapy-related leukemia,     several solid tumors and late toxicities such as cardiovascular or neuro-psychiatric diseases     which impact on quality of life. However little is known concerning long-term toxicity of     this class of new agents so called targeted drugs such as anti-CD20.      The primary objective of this cohort study is to estimate long term toxicity in NHL patients     (i.e. 10 to 20 years) using data already collected (i.e. internal analysis) and to compare     drugs consumption to that of controls (i.e. external analysis).   "
33301|NCT02849899|"     Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to     increased morbidity and reduced survival of transplants and patients. Corticosteroids,     anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major     diabetogenic impact and greatly contribute to the increase in diabetes prevalence after     transplantation.      There are to date few studies concerning the pharmacological prevention of post-transplant     diabetes. Hecking et al. have recently reported that a short treatment with insulin,     administered immediately after transplantation, reduce the incidence of de novo diabetes     one-year post-transplant. This study included 50 renal transplant patients and showed that a     three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The     occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group.      No further pharmacological strategy has been developed to date. Relevant experimental     evidences suggest that gliptins could be used in the pharmacological prevention of     post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which     inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory     polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations     which induce insulin secretion and inhibition of glucagon secretion. The gliptins are     approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins     have pleiotropic effects including a protective effect on β cells and anti-inflammatory     effect.      The additional cost associated with new-onset diabetes after transplantation could be also     significantly reduced by efficient prevention. A US study found that, for the period between     1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2     years after transplantation. Moreover, transplantation resulting in one of the best increases     of patients' quality of life, its estimate is essential in the treatment evaluation of this     population.   "
33302|NCT02849886|"     This study evaluates the frequency of occurrence, severity, and response to treatment by a     chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the case     of acute Graft versus Host Disease (aGvHD) occurring after the administration of     T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and     T-lymphocytes   "
33303|NCT02849873|"     The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac     Cream.   "
33304|NCT02849860|"     Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant     metabolites after topical dermal application of IDP-121 lotion.   "
33332|NCT02849483|"     Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies     reported that ramosetron is also effective treatment of irritable bowel syndrome. The     investigators examine the effect of ramosetron on postoperative bowel motility.   "
33305|NCT02849834|"     The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity     after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical     potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary     goal, the project will analyse possible correlations between the magnitude of cortical     plasticity and that of the pain-relieving effect.      In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory     cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a     cross-over randomized study.      Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4     weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over     randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI     (motor activation) performed before the first rTMS session and the last day of each session     of rTMS.   "
33306|NCT02849821|"     This is a prospective, controlled and observational study. Participants underwent a 3-hour     exposure to hypoxic conditions simulating an altitude of 4,000 meters above sea level     (m.a.s.l.) in a hypobaric pressure chamber. Clinical parameters, as well as blood and stool     samples and biopsies from the sigmoid colon (by sigmoidoscopy) are collected at subsequent     time points. The investigators goal is to evaluate if a 3-hour stay at high altitude (4, 000     m) can alter disease activity and can modulate a pro inflammatory reaction.   "
33307|NCT02849808|"     Corneal transplantation have been performed for several decades, follow-up time in some     centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary     considerably from center to center. These variations may be explained by differences in     case-mix and surgical techniques used.      The investigators aim to better understand the factors associated with long term graft     survival.   "
33308|NCT02849795|"     Body composition analysis and especially body fat distribution in regions of interest     (android and in particular intra-abdominal region) provides some information on the risk of     cardiovascular disease. There is little data available on the body composition analysis in     psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in     particular data on fat distribution in regions of interest regarding the risk of     cardiovascular disease.      Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic     properties that are interesting to explore in pathologies with a higher risk of     cardiovascular disease like psoriasis or psoriatic arthritis.      Adipokines have been investigated in psoriasis but fat tissue and in particular its     distribution (android/visceral or intra-abdominal) has not been studied in parallel.     Moreover, relation between adipokines and psoriasis area or severity has been studied but the     relation between adipokines and cardiovascular risk factors has not yet been investigated.      The aim of this study is to investigate relations between the body fat distribution,     adipokines rates and the risk of cardiovascular disease of these patients.   "
33416|NCT02848378|"     This study investigates the levels of advanced oxidation protein product and monocyte     chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25     participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally     healthy subjects are included into this study. In each participant, four sites are identified     for gingival crevicular fluid samples.   "
33552|NCT02846610|"     The German Network for acute pain management and Regional Anesthesia (NRA) is a multi-center,     non-interventional registry and benchmark project, assessing and analysing clinical and     patient-reported procedural and outcome data of systemic analgesia and regional anesthesia     hosted by the German Society of Anesthesia and Intensive Care Medicine (DGAI) and     professional Society German Anesthetists (BDA)   "
33309|NCT02849782|"     This prospective monocentric open label trial was realized in the Laboratory of Clinical     Functional Exploration of Movement at the University Hospital of Besancon. Cognitive     evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine     treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation,     respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1.      Fampridine was prescribed according to guidelines issued by the French Health Products Safety     Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement of     walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is recommended     to evaluate improvement after 2 weeks of treatment. According to the practitioner evaluation     between Pre 2 and Post 1 (i.e. before and after fampridine treatment), patients were     classified into 2 groups: responders whose clinical status was improved and non-responders     whose clinical status was not improved.   "
33310|NCT02849769|"     Following product approval, further confirmation of the MR Conditional Tachyarrhythmia     Therapy Systems sensing and detection performance post MRI exposure will be obtained by     actively monitoring de-identified device data obtained through the Medtronic CareLink®     Network.   "
33311|NCT02849756|"     Estimate the future six months after the admission in an intensive care unit of the patients     of 85 and more years old in terms of autonomy.   "
33312|NCT02849743|"     This research study will test if oxytocin, delivered by nasal spray, will promote weight loss     in children and adolescents with Hypothalamic Obesity as compared to a placebo. The study is     divided into two parts. During the first part, subjects will receive either oxytocin or     placebo. In the second part, subjects will cross-over to receive the other treatment -     either oxytocin or placebo. During study visits participants will do blood tests, physical     exams, metabolic testing, a MRI scan, and some surveys and questionnaires.   "
33313|NCT02849730|"     In this retrospective study, postoperative pain score, epidural patient controlled analgesia     (Epi-PCA) related complications, the risk factors for requirement of rescue analgesics and     antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl and     ropivacaine-based Epi-PCA during postoperative 48 hours after various surgeries.   "
33314|NCT02849717|"     The purpose of this study is to see whether exercise can improve the health and well-being of     patients scheduled to undergo surgery for a bowel related condition.   "
33315|NCT02849704|"     The objective of this study is to evaluate the malabsorption blood test (MBT), stool     coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential     screening or diagnostic tests for reduced exocrine pancreatic function or pancreatic     insufficiency (RPF/PI). A further objective is to determine the test responses before and     after pancreatic enzyme medication administration (Creon36™) in the patients with chronic     pancreatitis (CP).   "
33317|NCT02849678|"     This research study is testing whether the local anesthetic lidocaine is as effective as     ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve     blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in     this hospital for post-operative pain control for the past few years, thus has become the     standard drugs used for this nerve block. Lidocaine has numerous potential advantages over     ropivacaine, such as faster onset of action, better safety profile and greater     anti-inflammatory action. Catheters placed near both sides of a patient's spine for     postoperative pain control are called thoracic paravertebral nerve blocks and are a part of     routine care. Through those catheters, a numbing medication, or local anesthetic, to block     the transmission of pain from the surgical incision to the spinal cord, thus reducing pain.     The research part of the study is whether subjects will receive either the local anesthetic     lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine     controls pain better and facilitates a faster recovery after abdominal surgery than     ropivacaine.      In this research study, the investigators will compare patient-reported pain scores, any     additional pain medication requirements for adequate pain control, time it takes for bowel     function to return to normal following surgery, as well as the incidence of any side effects,     such as numbness and weakness, subjects may experience between those receiving lidocaine     versus those receiving ropivacaine. The investigators will screen 100 patients and enroll 60     subjects into this study.   "
33318|NCT02849665|"     Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight     newborn. The Kangaroo Position is the main feature of this method. The infant should be     lightly dressed, in prone position and upright against the torax of the parents. Researches     provides evidence that the Kangaroo Position induces an increase in myoelectric activity of     preterm newborn. However, it is unknown how long the newborn should remain in the kangaroo     Position so that ocurr changes in electromyographic. An increase in electromyographic     activity was observed after 24 hours or more of submission to the Position Kangaroo, however     period lower of submission to the Position Kangaroo have not been evaluated yet. Also unknown     are the physiological mechanisms that cause this muscle response. One hypothesis would be the     increase in temperature caused by skin to skin contact which could improve circulation in     small vessels with direct influence on the infusion and nutrition of muscle tissue.     Objective: Evaluate the immediate effect of Kangaroo position in the electromyographic     activity and microcirculation of preterm newborn. Method: It will be a randomized and     controlled trial from August 2016 to February 2017 with newborn preterm admitted at the     Kangaroo Unit, IMIP. Newborns eligible according to the inclusion and exclusion criteria will     be randomized into two groups: Kangaroo Group (experimental group) and Not Kangaroo Group     (control group). The data of the electromyographic activity and the microcirculatory     parameters will be assessed and recorded in three stages: before the Kangaroo position, one     and three hours after of continuous submission in the Kangaroo Position (for the group of     cases) and before the Kangaroo position, one and four after the three assessments (for the     control group). In the control group, the preterm newborns will be not submitted to Kangaroo     position until the completion of the last and third evaluation. The acquisition of the     electromyographic signal will be conducted through an equipment electromyography Miotool 400®     brand (Miotec Equipamentos Biomédicos - Brasil). To assess microcirculation will be used for     the white light spectroscopy method through the drive moorVMS-OXY®. The project was submitted     and approved by Ethics Committee for Research on Human Beings of IMIP (52381915.5.0000.5201).     This study is part of a anchor project approved by Conselho Nacional de Desenvolvimento     Científico e Tecnológico- CNPq (process 458163/2014-7).   "
33319|NCT02849652|"     Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000,     the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times     greater than in the general population. Further, even the recent small decline in smoking     rates that has been reported in the general population in the past decade has not occurred     among smokers with an SMI. In fact, 44% of all the cigarettes consumed in the US are by     individuals with a psychiatric disorder and the primary cause of death among Americans with     an SMI is a tobacco-related disease.      This cluster randomized trial will be conducted in 14 Philadelphia community mental health     clinics (CMHCs). Clinics will be randomized to either Addressing Tobacco Through     Organizational Change model (ATTOC) or Usual Care (UC) treatment groups. The investigators     hypothesize that 1) at the end of the intervention and at a 3-month follow-up, rates of     adherence to guidelines for treating TUD will be greater among clinic personnel that receive     the ATTOC intervention vs. clinic personnel in usual care; 2) at the end of the intervention     and at a 3-month follow-up, rates of client smoking cessation will be significantly greater     in clinics that receive the ATTOC intervention than among clients treated with usual care;     and 3) using non-inferiority testing, at the end of the intervention and at a 3-month     follow-up, there will be no significant degradation in mental health functioning or QOL among     clients who receive care at clinics that received the ATTOC intervention than among clients     treated with usual care.   "
33320|NCT02849639|"     The study will examine the impact on cognitive reserve of a pharmacist-physician     patient-centered medication therapy management intervention to address inappropriate     medication use as identified by the Beers 2015 list. By bolstering cognitive reserve, this     project will directly address the National Alzheimer's Project Act 2015 priorities serving to     delay onset of symptoms in preclinical dementia. The results of this study will provide     valuable insights on how to expand this intervention to reduce the prevalence and associated     healthcare costs of symptomatic Alzheimer's disease.   "
33321|NCT02849626|"     This is an open-label, multicenter study with an extension phase to evaluate the safety and     tolerability of an perampanel oral suspension when administered as an adjunctive therapy in     children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or     primary generalized tonic clonic seizures (PGTC).   "
33322|NCT02849613|"     Stroke is the second leading cause of death in the world population. When not fatal, stroke     often results in disability, and secondary health problems affecting not only patients but     also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE     will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery     and patients quality of life.   "
33323|NCT02849600|"     This is a retrospective cohort study with two specific aims. The first aim focuses on the     treatment outcome of different VPT protocols in young permanent tooth. The second aim is to     determine if MTA is a suitable material in VPT and related factors potentially influencing     prognosis.   "
33362|NCT02849093|"     The primary aim of the study is to investigate whether optical coherence tomography (OCT) may     be a useful tool for investigating the in-vivo histology of ocular structures in patients     with tear film pathology. In epiphora the investigators will image the proximal lacrimal     system. In dry eye syndrome the investigators will image the lacrimal gland and also the     buccal mucosa.      The secondary aim of the study is to investigate the appearance of the normal cornea and     conjunctiva under OCT imaging.   "
34291|NCT02836951|"     Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal     models. The objective of this study is to find whether similar markers are detectable in the     body fluids of human subjects that have sustained a TBI.   "
33324|NCT02849587|"     This study was authorized by the California Legislature (Assembly Bill 266, the Medical     Marijuana Regulation and Safety Act (73) to help with detection of driving under the     influence of cannabis. One hundred and eighty healthy volunteers will inhale smoked cannabis     with either 0% (placebo), 5.9%, or 13.4% Δ9-THC at the beginning of the day, and then     complete driving simulations, iPad-based performance assessments, and bodily fluid draws     (e.g., blood, saliva, breath) before the cannabis smoking and a number of times over the     subsequent 6 hours after cannabis smoking. The purpose is to determine (1) the relationship     of the dose of Δ9-THC on driving performance and (2) the duration of driving impairment in     terms of hours from initial use, (3) if saliva or expired air can serve as a useful     substitute for blood sampling of Δ9-THC in judicial hearings and (4) if testing using an iPad     can serve as a useful adjunct to the standardized field sobriety test in identifying acute     impairment from cannabis.   "
33325|NCT02849574|"     To improve the management and risk reduction, it is essential to understand the evolution of     the consumption of psychoactive substances, medicated or not in detention; it does not have     at present no data on this subject. This work has as main objective to evaluate the     development of substance use terms (goods and consumption practices) by the inmates between     the period preceding their incarceration and their fifth month in detention.   "
33326|NCT02849561|"     With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio     respiratory arrest is a public health issue.      The goal of this study is to evaluate the pupillary light reflex measured by the dimension of     the pupil (diameter) as a prognosis factor neurological evolution in post cardiac arrest. By     participating to this study, the patient get the same tratments and exams than in a usual     managing cares.      In addition of these events, the pupillary light reflex is studied as soon as the patient is     accepted in the department, and then on the second day.      Currently, the evaluation of the neurological becoming rely on a multimodal clinical and     paraclinical approach.      The study of the pupillary light reflex measured by the diameter of the pupil could be a     prognosis factor of neurological evolution for patients in post cardiac arrest, so a reliable     and available prognosis marker in patient care.      The goal of this study is to evaluate the pupillary light reflex (RPM), measured by the     diameter of the pupil as a prognosis factor of neurological evaluation of admitted patients     after a cardiac arrest.      Principal criteria of judgement is the percentage of the pupillary light reflex variation     measured with Neurolight®, compared between two groups.   "
33327|NCT02849548|"     The purpose of this study is to examine effects of blocking the orexin system with suvorexant     after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD     symptoms, and intersession habituation.   "
33417|NCT02848365|"     Postoperative sore throat (POST) is a common problem following the use of endotracheal     intubation during general anaesthesia. It leads to dissatisfaction and discomfort after     surgery and can delay a patient's return to normal routine activities. POST has been rated by     patients as the eighth most adverse effect in the postoperative period. The incidence of sore     throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal     intubation also leads to hemodynamic stress response. The response can be deleterious in     patient with or without cardiac disease. It is related to the degree of manipulation of the     airway during endotracheal intubation and has been studied during intubation for some     equipment used for endotracheal intubation   "
33328|NCT02849535|"     The rise of oral targeted therapies favors outpatient care of cancer patients but exposes     them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to     treatment, inappropriate management of side effects and interactions with other co-prescribed     drugs. The clinical consequences (reduced efficacy and potentialized toxicity) are all the     more important that ambulatory monitoring of treatments prescribed at the hospital remains     underdeveloped due to default of coordination between these two settings.      Adverse drug reactions are a major concern, as such, and because they involve prescription     changes (dose reduction, treatment interruption). This results in a decrease in the dose     taken and a risk of loss of efficacy.      In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher     because the oral targeted therapies available in this indication have a safety profile marked     by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce     the treatment adherence (digestive and skin toxicities). In addition, these molecules are     metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with     drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss     of efficacy.      The investigators propose to assess a program set up to secure drug taking by enhancing     self-management of side effects and control of drug interactions by the patient. This program     includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent     pharmacist and liberal nurse) professionals.      The hypothesis of the study is that the PRISM care program will improve self-management of     side effects by the patient, resulting in a relative dose intensity of oral chemotherapy     improved compared to usual care.   "
33329|NCT02849522|"     This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS).     This register enables us to collect data on the treatment of LUTS using prostate artery     embolisation (PAE), and other surgical methods to answer the following questions posed by     NICE in 2013:        -  Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?        -  How does PAE compare with conventional surgical treatments? This will primarily be a          surgical procedure called TURP (see below).        -  Which patients would most benefit from PAE over the other treatment options? This is a          pilot study, and the final register will contain data from roughly 100 patients for PAE          and 100 patients for the other surgical interventions, allowing us to answer NICE's          research questions, update NICE guidance documentation, and do further research with          more patients if necessary.      Our hypothesis is:      • PAE produces significant improvements in the IPSS score 12 months post-procedure   "
33330|NCT02849509|"     The aim of this non-interventional study is to describe patient's perception of anticoagulant     treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from     atrial fibrillation (according to its approved indication in the approved dosages of 110 mg     or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).   "
33333|NCT02849470|"     Purpose The primary objective of this study is to evaluate the safety and efficacy of the use     of a biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction     (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP) as compared with     adipose-derived cell-enriched SVF (AD-cSVF) + AD-tSVF and HD- PRP concentrates in treatment     of androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL).      Assigned Interventions        1. HD-PRP + Matristem Matrix (ACell)        2. Experimental: HD-PRP + Emulsified AD-tSVF        3. Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF Device: Tulip          Microcannula Closed Syringe For All Lipoaspiration (2.11 mm Diameter, offset Carraway)          Centrifugation technique to acquire concentrated platelets (per manufacturer's approved          protocol) Healeon ACM Emulsification System that prepares microcannula harvested AD-tSVF          for small needle (25g) retrograde threaded intradermal scalp injection.      Healeon Centricyte 1000 system for cellular isolation of AD-cSVF from AD-tSVF and testing by     Flow Cytometry (ORFLO MoxiFlow) Procedure: Closed syringe microcannula lipoaspiration     (AD-tSVF) Procedure: Emulsification of AD-tSVF via Healeon ACM Protocol (Newbury Park, CA,     USA) Procedure: Biocellular mix of emulsified AD-tSVF and HD-PRP for intradermal injection in     scalp; (Arm 2) Procedure: Cellular isolation (AD-cSVF) Centricyte 1000 incubation/shaker     system using GMP certified, sterile Liberase MNP-S (Roche #06297790001) for enzymatic     digestion manufacturer standard protocol. Creation of emulsified AD-tSVF + PRP +     cell-enriched AD-cSVF for intradermal injection in scalp (Arm 3) Sham Comparator: No Fat     Control using Emcyte II PRP Concentrate + Matristem (Acell) for subcutaneous scalp injection     patterned per square centimeter of scalp. Procedure: Emcyte Pure PRP® II system to     concentrate Platelets via using manufacturer standard protocol   "
33334|NCT02849457|"     Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled,     double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis     Complex who are less than 6 months of age prior to the onset of their first seizure   "
33335|NCT02849444|"     A prospective, multicentre, post-authorisation observational study. The objective of this     study is assess the response of renal function in clinical practice to anti-multiple myeloma     therapy in patients with relapsed MM and CrCl <50 mL/min/1.73 m2.   "
33336|NCT02849431|"     This study explores the feasibility of a mindfulness-based intervention for people with a     diagnosis of borderline personality disorder.   "
33337|NCT02849418|"     This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with     neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not     been adequately managed with medications for urinary incontinence due to NDO.      This study consists of a screening phase up to 28 days followed by a double-blind Treatment     phase 1 of 12 to 48 weeks wherein subjects will receive a single treatment of either     GSK1358820 200 Units (U) injection or placebo injection. After the first treatment, subjects     who meet the re-treatment criteria between 12 to 36 weeks can enter an open-label Treatment     phase 2 to receive a second treatment with GSK1358820 200 U. Subjects will be permitted to     receive re-treatment up to 2 times, and there should be a gap of minimum of 12 weeks since     the previous treatment. The duration of overall treatment phases is 48 weeks. The total     duration of participation for any subject will not exceed 52 weeks, including screening.   "
33418|NCT02848352|"     The study aimed at identifying whether different expectations have an impact on experiencing     emotions in the form of sadness.   "
33338|NCT02849405|"     Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is     known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an     impact on the entire vascularization including the microvascularization. The retina is a     nervous tissue that is supported by microvascularization. Therefore, systemic diseases that     affect the nervous or the cardiovascular system are susceptible to have manifestations in the     retina. Retinal signs associated to the risks to develop CAD (qualitative appreciation;     diameter and appearance of arterioles) have been suggested. A quantitative approach would     strengthen the interpretation of these evaluations.      The Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - has the     capacity to identify and quantify a variety of biomolecules specific to the retina and the     optic nerve.      The purpose of this pilot study is to determine if the MHRC has the capacity to detect a     specific hyperspectral signature in the retinal arterioles of subjects suffering from     arteriosclerosis.   "
33339|NCT02849392|"     Research investigating beneficial effects of regular pistachio feedings on body composition     (BC) and blood lipids are limited, and there are no studies that have investigated the     effects of feeding pistachios on bone density or membrane incorporation of fats. The purpose     of this study is to examine the effects of pistachio consumption on body composition, bone     density, markers of bone turnover, erythrocyte membrane incorporation of fatty acids, lipid     status, inflammatory markers, dietary quality/micronutrients and satiety using a cross-over     study with two 12-week treatment periods (pistachio added (20 percent of kcals) and a     no-pistachio control diet), separated by 15-week washout period. The investigators will     recruit 30 female students from Cal Poly, San Luis Obispo (CP-SLO) and female 30 students     from Cal Poly, Pomona (CP-P) facilitating a collaborative project and using the expertise of     both Dr. Laura Hall (CP-SLO) and Dr. Bonny Burns-Whitmore (CP-P). The investigators hope to     show the health benefits of pistachios as part of an overall healthy lifestyle.   "
33340|NCT02849379|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     recurrent tongue cancer.   "
33341|NCT02849366|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     recurrent sarcoma.   "
33342|NCT02849353|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     recurrent ovarian cancer.   "
33343|NCT02849340|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     recurrent cervical cancer.   "
33344|NCT02849327|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     recurrent pharyngeal cancer.   "
33345|NCT02849314|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     recurrent laryngeal cancer.   "
33364|NCT02849067|"     It is known that laughter can bring benefits in terms of physiological and psychological     parameters, in addition to improving the individual's quality of life. However, the     literature is still scarce as to the existence of studies investigating the effects of a     comedy film specifically in hemodynamics.   "
33365|NCT02849054|"     To determine the appropriate volume (size) of ventilator breath during volume-targetted     ventilation for infants born with congenital diaphragmatic hernia.   "
33400|NCT02848586|"     The purpose of this study is to determine if using e-cigarettes (ECIG) rather than regular     tobacco cigarettes alters lung inflammation in people with HIV. The study is also interested     in asking subjects their opinion on the use of ECIG and how they make them feel. This study     is for research purposes only and is not intended to treat asthma or HIV or to modify tobacco     use.   "
33346|NCT02849301|"     Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the     majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S.     healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths     are directly attributable to PTB.      Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs     that can slow or stop labor contractions in the attempt to delay births preceded by PTL.     Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In     most of these women, PTL stops, but as their risk of PTB remains high, some have advocated     use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance     tocolytic agent has been shown to be beneficial in preventing PTB.      The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin     pessary compared to standard care in singleton gestations with arrested PTL and with short     transvaginal ultrasound (TVU) cervical length (CL) <25mm   "
33347|NCT02849288|"     The trial is designed to assess safety and feasibility of the Bigfoot Biomedical Type 1     Diabetes Management System (T1DMS) in up to 50 participants in a closely monitored Clinical     Research Center (CRC) environment.   "
33348|NCT02849275|"     The EPOCH-1 research intervention aims to examine the effects of a fermented dairy beverage     consumption on changes in behavioral and biological measures of cognition and stress among     obese adults.   "
33349|NCT02849262|"     The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan     in patients with external genital warts.   "
33350|NCT02849249|"     The study was designed according to the draft of allergenic product regulation published by     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of     subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and     Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma.     In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes     and skin reactivity.   "
33351|NCT02849236|"     Breast augmentation surgery can cause important postoperative pain, especially when bilateral     subpectoral implants are used. The investigators hypothesized that a technique of regional     analgesia, the pectoral nerve block type I (or PECS I block) would reduce pain within the     first twenty-four hours and, in turn, morphine consumption and associated side effects. This     is a randomized, controlled, double-blind study which compares intra and postoperative     analgesia with or without PECS I block in breast surgery.   "
33352|NCT02849223|"     The primary aim of this study is to assess the magnitude of transcranial direct current     stimulation (tDCS) -induced cognitive and functional change in patients with mild traumatic     brain injury. This study will also attempt to identify biomarkers associated with treatment     response. Last, acceptability and tolerability of procedures will be assessed. To accomplish     these aims, a randomized, double-blind, sham-controlled, parallel groups, pilot study will be     conducted in which participants are assigned to 24 sessions of tDCS or sham stimulation     offered concurrent with working memory training. Neural efficiency will be measured with     electroencephalogram (EEG) pre and post-intervention.   "
33353|NCT02849210|"     The study was designed according to the draft of allergenic product regulation published by     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of     subcutaneous immunotherapy with Olea europaea pollen extract in patients with     rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy     parameters will be evaluated: immunoglobulin level changes and skin reactivity   "
33356|NCT02849171|"     This is a pilot study. The purpose of this study is to test if an imaging tracer, not     approved by the FDA, called 18F-Fluorocholine (18F-FCH) is useful for evaluating this type of     cancer. This tracer is used to perform PET scans. The researchers want to see if the 18F-FCH     PET scan, using the study tracer 18F-FCH, can improve upon the usual scans at diagnosing or     monitoring this type of cancer.      In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true     tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It     is important to distinguish true tumor growth from inflammation since inflammation indicates     the tumor is responding to treatment. With standard MRI, it is difficult to determine if     changes following treatment are due to tumor growth or inflammation early on. Researchers     hope to learn if the investigational tracer, 18F-FCH, will be able to distinguish true tumor     growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.   "
33357|NCT02849158|"     Single center interventional study to explore activity of fibroblasts in the tumor and away     in the healthy rectal tissue.   "
33358|NCT02849145|"     Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate     in the blood, before and after curative resection of hepatic metastasis of uveal melanoma     (HMUM) and during post-surgery follow-up   "
33359|NCT02849132|"     Patients who have completed 2-years entecavir-based treatment in Regress Study will receive     another 5-years entecavir extension therapy. Patients will be assessed at baseline and every     six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver     ultrasonography, and Fibroscan; A third liver biopsy will be performed at year 3 in patients     who have significant fibrosis at second biopsy. CT and endoscopy will be performed at     baseline and year 3.   "
33360|NCT02849119|"     Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be     performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less     utilized than TP approach because of technical difficulties when using rigid laparoscopic     instruments in the small space of retroperitoneum cavity. However, with advanced surgical     skills and thoughtful patient selection, RP approach may be associated with shorter operative     time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS) compared     with TP approach.      Therefore, the investigators performed randomized control trial to compare the outcomes of     the two approaches (TP-LPN or RPN vs RP-LPN or RPN).   "
33361|NCT02849106|"     Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture     3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this     technique for treatment response in patients treated by two different chemotherapies (FOLFOX     or FOLFIRI) for colorectal cancer.   "
33366|NCT02849041|"     Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the     smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are     carcinogenic. Tobacco smoke is the leading preventable cause of cancer in humans since it is     responsible for lung cancer, upper aerodigestive tract (mouth, pharynx, larynx, esophagus),     nasal cavity and sinuses, stomach, pancreas, liver, bladder, kidney, uterine cervix, and some     myeloid leukemias.      This study aims to evaluate the combined effect of the scanner and the search for circulating     tumor cells (CTC) on screening for tobacco-related cancers, accompanying smokers to cessation     and addressing the psychological impact this approach.   "
33367|NCT02849028|"     Microbiome studies may be highlighted as crucial in the development of sleep disorder for TBI     patients. The microbiota-gut-brain connection may further provide an opportunity for     microbiota manipulation to treat the TBI patients with sleep disorders.This study is to     investigate whether exist the relationship between sleep disorder and circadian rhythm of     patients with TBI or not and focus the study on the potential of the host-microbiota     interaction in regulating sleep disorder.   "
33368|NCT02849015|"     The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK)     immunotherapy to tumors in transplanted liver.   "
33369|NCT02849002|"     The primary objective of this study is to collect un-blinded BrainPulse recordings from youth     and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to     improve a concussion detection algorithm previously developed by Jan Medical, Inc. Subjects     will be followed for 21 days after the initial injury with BrainPulse recordings to study the     subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse     recordings will be entered in a database to assess clinical outcome and device     utilization.BrainPulse(TM)   "
33370|NCT02848989|"     Studies have shown that on-going pain following breast surgery is common and may limit the     ability to participate in physical activity, cause tiredness, difficulty in daily     chores/activities as well as other problems.      This study is evaluating whether participating in a 12-week Qigong program (pronounced chee     kung), an exercise program that involves gentle movements combined with breathing/relaxation     techniques, also known as mind-body exercise, leads to improvement of pain, physical     function, and quality of life among breast cancer survivors that have significant pain     following surgery.   "
33371|NCT02848976|"     Regular physical activity promotes physical and mental well-being in the general population.     Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or     because of deficiencies related to the disease, or even on the advice of their caregivers in     order to save their functional abilities. Time for leisure activity could be almost 20% lower     in MS patients compared to healthy controls, and this situation is likely to aggravate the     functional symptoms of multiple sclerosis.      The literature described the benefit of physical activity for MS patients according to     protocols and varied assessments. Evaluations were indeed concern very analytical elements of     metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account the     performance of components or fatigue and quality of life. Due to the multiplicity of RE     protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the double     issue was the profit earned by an RE program and of this benefit by level of severity of MS.     The main objective of our study was an evaluation of the effects on fatigue and quality of     life of a retraining program to effort suitable for levels of impairment and patients with MS     activity limitations. The secondary objective was checking a performance improvement of the     patients in this adapted program.   "
33372|NCT02848963|"     ASA I-II 3-12 years old children participated to this study. All Participants will divide     into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at     anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of     ketamine-propofol mixture with %67 of Mcfarlan dose regiment.      In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia     induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol     mixture with %80 of Mcfarlan dose regiment.      In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction.     General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90     of Mcfarlan dose regiment.      After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU     will be recorded. These data will be evaluated with statistically.   "
33373|NCT02848950|"     The basis for obesity's impact on reproduction is not well characterised and there is a     controversy whether the key organ influenced by it are the ovaries or the uterus.      Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to     determine if Metformin helps to increase fecundability by affecting the uterus in women     undergoing ART. As a surrogate marker- flows in the uterus will be tested during the     treatment.   "
33374|NCT02848937|"     This study aimed to evaluate the effect on the calcium balance of a concentrate with 1 mM     citrate and locate the equivalent concentration of calcium (Ca_eq) at a concentration of 3 mM     acetate and traditional with 1.5 mM calcium in HD. The secondary objective is to evaluate the     performance in the medium term of purifying the concentrate with 1 mM citrate and Ca_eq,     compared to traditional concentrated with 3 mM acetate and 1.5 mM calcium in HD.   "
33375|NCT02848924|"     Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in     cases of severe bleeding. In all cases the functional is a major issue with a potential reach     of walking ability and maintaining the seated and standing positions. The treatment of such     lesions requires management to a specialist, or the ability to use such centers for advice or     transferring patients. This organization was recommended after the symposium of the French     Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and     clinical features of these fractures have evolved to worsening the functional prognosis. Club     Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and     practices at national and regional level. The long-term objective is to propose a regional     organization of care of these patients in order to reduce morbidity and mortality associated.   "
33376|NCT02848911|"     The purpose of the study is to determine the maximum tolerated dose (MTD) in patients with     acute lymphoblastic leukemia (ALL) and to determine the safety and tolerability of increasing     doses and different infusion times of AFM11 infusion in patients with adult B-precursor ALL   "
33379|NCT02848872|"     The hypothesis of this study is that functional tumor infiltrating lymphocyte (TIL) isolation     from resected lung cancer specimens is feasible, allowing determination of tumor     antigen-specific T cell reactivities. The primary objective of this study is to investigate     the feasibility of isolating functional tumor infiltrating lymphocytes s(TILs) to determine     tumor antigen-specific T cell re-activities in 30 resected lung tumor specimens. Successful     isolation of TILs will be defined as collecting 1x10-6 viable, CD45+ mononuclear cells or     greater from tumors containing >/=1 gram of excess tissue. If successful isolation of TILs     can be obtained from >/= 66% of resected tumor specimens, the protocol will be considered     feasible. The primary exploratory objective is to identify immunologic signatures that     predict clinical outcomes from cytotoxic chemotherapy and/or immunotherapy.   "
33380|NCT02848859|"     This is a pilot study randomizing patients with insomnia and coronary heart disease to either     general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia     versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy     at a later date).   "
33448|NCT02847962|"     Corn-soy vitamin and mineral fortified blended foods (FBFs) are primarily used for food aid,     although sorghum and cowpea may be suitable alternative FBF commodities. The objective of the     Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania Efficacy Study is to     determine whether newly formulated, extruded sorghum- and cowpea-based FBFs have equal, or     better, nutritive value and acceptance compared to a traditional corn-soy blend. The     effectiveness of each blend will be determined in an efficacy study of Tanzanian children     under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin A.   "
33593|NCT02846077|"     The project is designed to document in college undergraduates the relationships among     sleep/wake timing and duration, use of mobile phones and other electronic devices, food     timing and content, self-reported mood and physiological measures.   "
33381|NCT02848846|"     The NEBIAS (NEurocontrolled BIdirectional Artificial upper limb and hand prosthesiS)     proposal aims at developing and clinically evaluating (in selected amputees) a     neuro-controlled upper limb prosthesis intuitively controlled and felt by the amputee as the     natural one. This will be possible by means of a novel neural interface able to provide a     stable and very selective connection with the nervous system. This goal will be achieved by     combining microtechnology and material science and will allow, on one side, recording of the     motor-related signals governing the actions of the amputated hand/arm for the motion control     of a mechanical prosthesis, and on the other providing sensory feedback from tactile and     kinesthetic sensors through neuromorphic stimulation of the adequate afferent pathway within     the residual limb. The NEBIAS proposal is also aimed at finding out the 'language'     intrinsically linking central nervous system with peripheral nerve signals in order to govern     simple and complex hand/fingers movements. To reach this goal, a variety of techniques     exploring brain and nerve functions will be assembled and integrated; this includes the     analysis of electromagnetic brain and nerve signals, as well as of movement-related changes     in brain's blood flow/metabolism.   "
33382|NCT02848833|"     To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type     2 diabetes mellitus in a routine clinical practice setting   "
33383|NCT02848820|"     OBJECTIVE      The aim of this study is to compare the effectiveness of initial non-operative treatment     strategy (reserving appendectomy for those not responding or with recurrent disease) with     immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple     appendicitis in terms of complications, health-related QOL and costs.      Main research question: What is the difference in proportion of patients experiencing     complications within 1 year between both strategies in children from 7 to 17 years old,     inclusive, with acute simple appendicitis?   "
33384|NCT02848807|"     Determine whether nutritional support with high protein ONS in adult oncologic patients in     the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of     systemic therapy.   "
33385|NCT02848794|"     The study is aimed to evaluate the efficacy and safety of Apatinib and Irinotecan in patients     with recurrent high-grade glioma.   "
33386|NCT02848781|"     The current standard of care for ventricular tachycardia (VT) includes the use of medicine     called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy.     These treatments are used to terminate the irregular heartbeats and bring the heart back to a     normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the heart cells     causing the arrhythmia. Patients eligible for this may benefit from an ablation procedure in     addition to an ICD to treat their VT condition or risk of developing VT. This study aims to     show that treating VT with catheter ablation, if performed preemptively at the time of ICD     implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to improved survival.   "
33387|NCT02848768|"     The purpose of this study is to validate of a predictive nomogram of response or resistance     to targeted therapies in metastatic clear cell renal cell carcinoma   "
33388|NCT02848755|"     Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high     risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive,     inexpensive bedside tool and examinations can be repeated as often as necessary without major     disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent     acoustic windows to examine the deep midline and periventricular regions of the brain.Some     data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial     US is not very suitable for investigating cortical regions or structures in the posterior     fossa. There is limited data for very preterm infants.The investigators aimed to measure     ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge     number of infants.   "
33389|NCT02848729|"     This study is to test the hypothesis that an opioid used to treat postsurgical pain, IV     morphine, will impact the absorption of coadministered oral acetaminophen and result in     altered pharmacokinetics in healthy subjects.   "
33390|NCT02848716|"     This is an international, prospective, multicenter and randomized phase III study designed to     determine if patients with locally advanced cervical cancer have longer overall survivals     with pretherapeutic paraaortic surgical staging when compared to radiologic staging.   "
33401|NCT02848573|"     we propose this study and try to find out possible clinical applicable non-invasive imaging     indices or its combination with the laboratory indices to predict the status of hepatic     fibrosis in BA patients.   "
33391|NCT02848703|"     Myocardial perfusion is a major parameter characterizing the status of capillary circulation     of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI)     during the 1st pass of a contrast agent through the capillary system. This technique is     radiation-free, but it is difficult to repeat measurements during a single exam. Also, a     number of patients suffering from cardiac disease cannot receive contrast agent injections.     The investigators have developed a totally non-invasive approach for quantifying myocardial     perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the     capillaries (Arterial spin labeling, ASL).      Goal : The major goal of this research protocol is to validate a totally non-invasive method     of myocardial blood flow quantification using MRI without contrast agent injection   "
33392|NCT02848690|"     This parallel, randomized clinical trial will include 120 participants. They will be     allocated to a sodium restriction educational intervention or usual care groups. The     educational intervention will be planned based on the DSRQ application and sessions will be     conducted once a month for the period of six months. Both spot urine collection to estimate     sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end     of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will     be conducted at the beginning and at the end of the follow-up. Anthropometric measurements,     blood pressure measurement and 24-hour food recall will be collected during follow-up.   "
33449|NCT02847949|"     This is a Phase 2 multi-center, open-label study that allows subjects who derived clinical     benefit after completing IGN002 treatment in a separate Valor study (e.g. IGN002-101) to     continue treatment with IGN002. Subjects who completed a separate Valor-sponsored IGN002     study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are     eligible to participate in this study.   "
33450|NCT02847936|"     Surgical repair of perineal lesions after delivery can be associated with infection of the     surgery site. The aim of this study was to compare the surgical site infection with     triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after     delivery.   "
33393|NCT02848677|"     Cardiovascular disease (CVD) is considered the main cause of mortality in the western world.     There are many factors that contribute to the onset and progression of cardiovascular     disease, including hypertension. Hypertension is a multi-factorial condition that includes     nutritional disorders in its causality line. It is believed that advanced glycation     end-products (AGEs) is one of the pathophysiological causes that explain the occurrence of     high blood pressure in diabetic patients. This study has the role of describing the protocol     of a randomized clinical trial aiming to evaluate changes in serum levels of end products of     advanced glycation after an intervention for eating habit changes in hypertensive     individuals.      The investigators designed a randomized clinical trial, with non-blinded assessment of     outcomes. Participants will be recruited from the outpatient clinic for hypertension of a     public hospital in Porto Alegre, aged from 40 to 80 years old and without diabetes.     Hypertension is defined as systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90     mmHg, or antihypertensive medication use. Participants will be assigned to one of two groups.     The intervention group will receive monthly educational intervention sessions for low salt     diet, high in fruits and vegetables, and low in processed foods for a period of 6 months.     Besides these, the intervention group will receive a standard telephone interview every two     weeks to motivate them to follow the diet. The control group will receive the usual     counseling for low sodium diet in monthly appointment with a dietitian, following the     hypertension care clinic protocol.      This study aims to investigate if there are significant changes in serum levels of advanced     glycation end products, after the nutritional intervention with diet guidance in fruits,     vegetables, low in sodium and processed foods in hypertensive patients because several     studies have shown that less processed food rich in antioxidants with low sodium content,     play an important role in reducing levels of AGEs which are precursors of vascular     inflammation and progression of cardiovascular diseases.   "
33394|NCT02848664|"     The purpose of this study is to develop appropriate training methods and gather participant     feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is     a small device that provides external vibratory stimulation to the larynx during swallowing     and swallowing training. A secondary purpose of the study is to determine how 3 months of use     of the PMSST affects swallowing physiology, brain activation, oral intake and quality of     life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the     vibratory device.   "
33395|NCT02848651|"     This is a Phase II, open-label, prospective, multicenter study designed to evaluate the     efficacy and safety of single-agent atezolizumab in participants with treatment-naive locally     advanced or metastatic NSCLC. In addition, the primary biomarker objective is to evaluate     various predictive cutoffs for novel blood-based diagnostic assays.   "
33396|NCT02848638|"     The primary goal of the study is to see if the PET/CT will be able to determine the precise     location of the Y-90 particles within the liver and within the tumors. We hope to use this     information in order to see if these particles distribute evenly throughout large tumors or     if the particles go into the tumor which is located in the portal vein.      The secondary goals are threefold. First correlate the distribution of Y90 particles (as     demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a     difference in the Y90 particle's distribution when a low particle load (1-3 million     particles) is used compared to when a high particle load (6-8 million particles) is used.     Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being     used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production     PET research imaging.   "
33397|NCT02848625|"     This study will evaluate whether regular yoga exercises designed specifically for patients     with Idiopathic Pulmonary Fibrosis is associated with any change in quality of life. Half of     the participants will be randomized to yoga, half to usual care. After the first group     completes 12 weeks of yoga, the patients who were randomized to usual care will completed 12     weeks of yoga.   "
33398|NCT02848612|"     To prevent thromboembolic complications, the embolization procedure is performed under     prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care     testing according to international guidelines. However, these guidelines are based on limited     scientific evidence and the ideal level of anticoagulation required has not been precisely     defined. Furthermore, the correlation between the point-of- care tests used at Amiens     University Hospital and the reference methods used in the laboratory varies considerably     according to the available literature.   "
33399|NCT02848599|"     The purpose of this study is to determine whether epidural levobupivacaine applied for the     purpose of post-operative analgesia compared to systemic analgesia with morphine leads to     better pain control, stronger suppression of the inflammatory response and the production of     inflammatory mediators, faster recovery of patients and consequently less incidence of     postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of     femoral fractures.   "
33402|NCT02848560|"     This is an observational study for children with Cystic Fibrosis (CF) who are eligible based     on their CF gene type. One group will be called the treatment group because they have the     gene type (homozygous F508del) that makes them clinically eligible through their CF care     provider to begin treatment with the new FDA approved CF drug called orkambi. For the control     group, children will be enrolled who have a similar CF gene type (heterozygous F508del) but     are not eligible to be prescribed orkambi.      The two groups will be followed for four visits over about 3 to 4 years to observe changes in     the lungs. Methods to measure the changes in lung disease will include:      MRI with non-FDA approved inhaled xenon gas to take detailed images of the lungs, Pulmonary     Function Tests (PFT), Lung Clearance Index (LCI), Baseline CT image of the lungs if not     ordered as part of usual clinical care.      The first two visits will be done before starting clinical treatment with orkambi and will be     a minimum of 28 days apart and up to 18 months. The third visit will be scheduled about 3     months after starting orkambi and the fourth visit about 18 months later. For the control     group, the timing of visits will be similar to treatment group and visits may be scheduled     around annual CF care visits.   "
33403|NCT02848547|"     An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this     study we estimate the incidence of type 2 diabetes among participants enrolled in the     diabetes prevention programme. This will provide comparison of the progression to diabetes     among group motivated through text messages and the group educated only during enrollment. A     total of 537 participants were enrolled in the primary study and are invited to participate     in a follow-up visit 3 years post active trial period.   "
33404|NCT02848534|"     The gold standard for diagnosing a bacterial infection is isolation of the pathogenic germ,     which is not easy in routine clinical practice.      Conventional markers do not have sufficient diagnostic value for making a rapid diagnosis on     admission. A 2004 literature calculated the diagnostic values of C-reactive protein (CRP) and     procalcitonin (PCT) levels for the diagnosis of bacterial infections, relative to other     causes of inflammation. For CRP, the sensitivity was 75% (95% CI: 62%-84%) and the     specificity was 67% (95% CI: 56%-77%). For PCT, the sensitivity was 88% (95% CI: 62%-84%) and     the specificity was 81% (95% CI: 67%-90%).      The first cellular immune response to infection consists of the mobilization of polynuclear     neutrophils from the bone marrow to the infection site under the effect of pre-inflammatory     cytokines, as well as the apoptosis of lymphocytes and their sequestration at the infection     site. This results in lymphopenia and the elevated polynuclear neutrophil count (PNN)     observed in bacterial infections.      Hence, it is legitimate to hypothesize that the neutrophil to lymphocyte ratio (NLR) can be     used in the diagnosis of bacterial infection. This ratio's value in the diagnosis of sepsis     in the emergency department was studied and the researchers found higher diagnostic values     than for CRP and PCT.      The NLR's potential value in the diagnosis of a bacterial infection in a context of fever or     hyperthermia (regardless of the presence or absence of bacteraemia) has not been studied     before. This ratio could also be compared with standard biomarkers (CRP and PCT levels, the     white blood cell count and the PNN).   "
33405|NCT02848521|"     This is a prospective, non-interventional study (NIS) measuring health-related quality of     life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD     patients in Europe.   "
33406|NCT02848508|"     To validate on the mid-term in moderate and severe renal failure (CKD 3-4) a nomogram to     adapt a fixed metformin daily posology according to renal function on the basis of the first     short-term study made by the investigators.   "
33407|NCT02848495|"     Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of     the general population. The devastating complication of IA is its rupture, resulting in     subarachnoid haemorrhage that can lead to severe disability and death.      Unfortunately, there are neither reliable clues nor diagnostic tools to predict the formation     and/or the fate of an IA in a given individual. Also, there is no pharmacological drug     available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage. Current     treatments are invasive with a significant risk of procedural morbidity. Thus, still now, the     management of patients with IA remains extremely challenging and still controversial.      Although the pathogenesis of IA has been the subject of many studies for the last decade, the     mechanisms underlying IA formation, growth and rupture are still mostly unknown and relevant     animal models of IA are not available.      Familial history of IA predisposes to IA formation and rupture and increasing evidence     suggest a genetic component of IA formation, with heterogeneous modes of inheritance and     penetrance.      This project, gathering neuroradiologists, geneticists and vascular biologists, addresses the     urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and     predictive tools of risk of IA.      The investigators propose to identify IA-causing variants by whole-exome sequencing in     familial forms of the disease.      The investigators hypothesises that the functional analysis of the causal / susceptibility     variants thus identified will provide clues to understanding the pathological mechanisms of     IA formation, and the bases for developing diagnostic tools. This project aims at meeting     this challenge. Based on preliminary data that already allowed to identify such a variant,     and the combination of genetic and functional investigations, the specific objectives of this     project are: - To identify IA-causing variants in familial forms of the disease by     whole-exome sequencing; - To understand the function of these genes/ variants in the     formation and rupture of IA by molecular and cellular approaches and generation of relevant     animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.   "
33408|NCT02848482|"     Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or     photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated     by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT     has been introduced as an important novel disinfection therapy in the field of implant     dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial     PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment     of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and     is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.      Inconsistent results have been reported regarding the potential role of PDT as an adjunct to     mechanical debridement in the management of peri-implant infection. Thus, the aim of the     present trial is to investigate the treatment effect of non-surgical treatment with and     without photodynamic therapy on initial peri-implantitis.   "
33409|NCT02848469|"     The Irish Omega-3 study is a clinical trial designed to investigate the potential of Omega-3     fatty acids in the reduction of risk of psychosis.      The study is being coordinated by the HRB Clinical Research Facility at University College     Cork. The Principal Investigator is Dr Maeve Rooney, Consultant Psychiatrist in the Mercy     University Hospital, Cork. The study will be carried out in collaboration with the HRB     Clinical Research Facility in Dublin in prior to rolling out to other centres around Ireland.      The Study is funded by Stanley Medical Research Institute, a non-profit organization     supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder.     It is the largest provider of funding for research in serious mental illness outside of the     U.S. government.   "
33410|NCT02848456|"     This study investigated the effects of spinal manipulation on central nervous system     activity. The presence of postactivation potentiation, an increase in muscular force     production following prior muscular contractions, was measured with electromyography and the     muscular force production during electrically-induced calf muscle reflexes. It was     hypothesized that significantly greater potentiation would be stimulated by a calf muscle     contraction with spinal manipulation delivered immediately beforehand than the potentiation     arising from the contraction only.   "
33411|NCT02848443|"     The main purpose of this study is to assess the safety and tolerability and to determine the     recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with     metastatic colorectal cancer.   "
33412|NCT02848430|"     Human safety studies will be carried out to test whether hop botanical dietary supplements     used by peri- and post-menopausal women are safe to use with Food and Drug Administration     (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at     the University of Illinois at Chicago without any harmful effects) will be given with four     selected FDA-approved drugs to determine if the hop supplement can increase or decrease how     these medications are absorbed, metabolized and excreted by the human body. Preclinical     studies predict that the hop supplement might affect the metabolism or break down of these     probe drugs.   "
33451|NCT02847923|"     The aim of this study is evaluate a software developed for alternative communication designed     for people with speech difficulties. The software was executed by 30 volunteers using mobile     devices that helped to play the scenarios simulated of communication situations.   "
33419|NCT02848339|"     Data about aspirin desensitization for patients with coronary artery disease undergoing     percutaneous coronary intervention are sparse.      This is a prospective, multicenter, observational study including 7 italian centers, to     assess safety and feasibility of a standard desensitization protocol in patients with aspirin     sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity     undergoing coronary angiography are prospectively enrolled.All patients underwent the     desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg)     administered orally at predefined intervals, with the procedure lasting 5.5 hours.All     patients are followed for desensitization procedure success, description of reactions due to     the desensitization procedure, and in hospital major adverse cardiac events (MACE). All     patients are also followed-up for 12 months in order to assess their long-term risk of MACE,     compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.   "
33420|NCT02848326|"     This study will evaluate the safety and tolerability of the following doses of AGN-241689: 10     mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the     prevention of episodic migraine and will characterize the dose/response relationship.   "
33421|NCT02848313|"     This is an open-label, Phase 1 single-center study in approximately 40 subjects who have 1     eye with intermediate AMD, including a high-risk drusen without geographic atrophy (GA)     subgroup and a noncentral GA subgroup. Eligible subjects will receive 40 mg of elamipretide     administered as a once daily 1.0 mL subcutaneous injection for 12 weeks.   "
33422|NCT02848300|"     This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost     Formulation A and Formulation B following 14 days of once daily topical administration in     male participants with androgenetic alopecia (AGA).   "
33423|NCT02848287|"     Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA     are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are     several preventive strategies but none of them completely prevent EA.      Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might     reduce the incidence of postoperative EA.   "
33424|NCT02848274|"     The purpose of the study is to develop a prognostic index model for the rare disease of     mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical     data at various institutions. The investigators hope this will enable the identification of     low- and high-risk groups for survival in order to improve patient care and outcome.   "
33425|NCT02848261|"     The primary objective of this project is to examine the impact of a continuous glucose     monitoring (CGM) intervention on health and psychological outcomes in young children with     type 1 diabetes (T1D).   "
33427|NCT02848235|"     Kenya recently adopted new treatment guidelines for pregnant women with HIV, which calls for     all women to initiate triple-drug antiretroviral therapy (ART) at or soon after their first     visit for antenatal care. As part of this new standard of care to prevent mother to child     transmission of HIV (PMTCT), Kenya also established the Kenya Mentor Mother Program (KMMP) in     2012 to provide guidance for standardizing peer education and psychosocial support services     within the national PMTCT program. This new standard of care (life-long ART and the KMMP)     will only yield significant improvements in preventing mother to child transmission if women     accept the triple-drug treatment during pregnancy and adhere to visit schedules so that they     receive uninterrupted supplies of their medications during pregnancy through at least the     cessation of breastfeeding. The primary objectives of this study are: (1) to evaluate     implementation of the new guidelines in Kenya under actual, real-world conditions in major     maternal and child health clinics in the southern Rift Valley region of Kenya; and (2) to     evaluate, also under routine program conditions, the benefits of an innovative intervention     package designed to improve implementation of the new treatment guidelines. The intervention     uses the existing Mentor Mothers, who already are part of the PMTCT program staff at clinics.     At the end of each clinic visit, the Mentor Mother will review with patients their treatment     plan and schedule their next visit. The Mentor Mother will also offer, at each encounter, to     send a text message reminder to the patient for their next clinic visit and offer to set up     an automatic reminder directly on the patient's cell phone. The intervention strategy was     developed in close collaboration with local health facility and PMTCT program staff based on     their prior and on-going experience providing PMTCT services in the region, and this strategy     has the potential to dramatically improve PMTCT service delivery and support global goals to     eliminate mother to child transmission.      The study is taking place in 12 clinics in the south-rift valley region of Kenya. A total of     360 patients will be enrolled into the study (approximately 30 at each clinic). The     investigators are enrolling patients to receive their permission to look at information     recorded in their medical records. All patients eligible for the study, who provide written     consent, will be included in the study until the target number of 360 is obtained. After     consenting, the study will have no further contact with patients. Because the study only     reviews information in medical files that clinics already collect as part of routine care,     risks to patients are minimal. The only possible risk is the accidental disclosure of HIV     status, but the study is designed to minimize such a risk. There are no direct benefits to     study participants, as the study is designed to understand existing adherence to PMTCT care     and treatment and to improve such adherence. The study is expected to start in 2016 and end     in 2019.   "
33428|NCT02848222|"     The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist     Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be     done by assessing for improvement in ocular oil gland function and comfortable contact lens     wearing time after one month of daily warm compress application. The efficacy of the Bruder     Moist Heat Compress applied once will be compared to twice daily application as well as     compared to warm compress application using a wash cloth.   "
33453|NCT02847897|"     The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in     patients with vaginal prolapse. Eligible subjects will receive 3 treatment sessions, 4 weeks     apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.   "
38712|NCT02778893|"     Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as     first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI)     response rate (ORR), prolong time to progression (PFS), improve patient survival.   "
33433|NCT02848157|"     Caudal block is often performed to relieve postoperative pain in pediatric urological     surgery. Recently, pudendal block is also used in penile surgery and it has advantage because     of less side effects such as transient weakness of low extremities, but limited to use in     penile surgery. Local anesthesia is a single shot injection, so additional analgesic drugs is     required when the effect of local anesthetics are disappeared. Dexmedetomidine, an alpha     adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect and     potentiates the effect of local anesthetics. There are many studies about the potentiation of     the effect of local anesthetics when added to dexmedetomidine in adults, it has been limited     in pediatrics. Recent study said that local anesthetics with dexmedetomidine had prolonged     duration of analgesia in caudal block, also in ilioinguinal block. Thus it is expected to     have a prolonged effect when investigators use dexmedetomidine in pediatrics as well as     adults.   "
33434|NCT02848144|"     Infectious shocks are associated with high mortality rates (20-40%). Anti-inflammatory     strategies based on the postulate that mortality related to sepsis is mainly due to an     overwhelming pro-inflammatory immune response have failed. Some patients surviving this     initial phase can develop immune dysfunctions because the compensatory mechanisms become     deleterious when they persist over time. The persistence of immunosuppression at day 3 or 5     is independently associated with more nosocomial infections and higher mortality rate. The     clinical and laboratory evidence for sepsis induced immunosuppression have been recently     reviewed by Hotchkiss et al. Apoptosis-induced depletion of immune effector and blood studies     from septic patients showed decreased production of pro-inflammatory cytokines, decreased     HLA-DR expression, increased percentage of regulatory T cells, and increased production of     programmed cell death (PD)-1. Some small positive phase 2 trials of biomarker guided immune     enhancing agents granulocyte-macrophage colony stimulating factor (GM-CSF) and interferon γ     (IFN γ) have been reported.      There are insufficient data showing that such an immunosuppression exists in children. Only     one study performed in children with organ dysfunctions admitted to pediatric intensive care     unit (PICU), showed that 34% of them developed immunosuppression. This study was performed on     a heterogeneous population and immunological analyses were limited. Therefore, there is a     crucial need of studies on septic patients with matched controls to provide more evidence     that the same paradigm exists in children. The collaboration of laboratories with a high     level of experience in this domain, and a clinical unit with a high potential of recruitment     of children with severe infectious shock should allow us to perform the first prospective     study specifically done in children with infectious shock.      The main hypothesis is that children with severe infectious shock developed sepsis-induced     immunosuppression as shown in adults. This will be assessed by the expression of HLA-DR on     monocytes' surface. We make the hypothesis that children who become immunosuppressed are more     prone to develop secondary nosocomial infectious and stayed longer in PICU and in hospital.      Children aged from 1 month to 17 years, admitted to PICU at HFME Lyon-Bron are eligible if     they have the criteria for severe sepsis or septic shock, defined by the Surviving Sepsis     Campaign 2012 or those of Toxic Shock Syndrome (TSS) (definitions of CDC - Center for     Disease Control). An information leaflet will be issued to parents and children / adolescents     and they will be informed of their right to object to the search. Are provided as part of     this research:        -  Immunological measures (mHLA -DR) in three stages: in the first 48 hours, between D3/5          and D7/9. The volume of collected blood will not exceed 2.4 ml / kg.        -  The collection of nosocomial infections and status at D30 A control group of patients          hospitalized for surgery without sepsis or toxic shock criteria will be recruited in the          same hospital by ICU investigators and matched for age. Similarly controls will be given          oral and written information and they will have the opportunity to deny inclusion. They          will have the same exams as the first group of patients.   "
33435|NCT02848131|"     The study goal is to assess the effect of senescent cell clearance on senescence burden,     physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC)     functionality in patients with chronic kidney disease (CKD).   "
33436|NCT02848118|"     Procedure sedation of flexible bronchoscopy (FB) comforts patients undergoing FB.     Hypoventilation during FB is a concern. The investigators investigate the feasibility of     monitoring capnography in FB sedation.   "
33437|NCT02848105|"     aGVHD remains as complication in patients after allogeneic stem cell transplantation.     Methylprednisolone at 1~2mg/kg is considered as standard first-line treatment. In recent lab     study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit     CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects.     In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment     may improve the outcome of aGVHD.   "
33438|NCT02848092|"     Teens with Attention-Deficit/Hyperactivity Disorder (ADHD) have high rates of negative     driving outcomes, including motor vehicle crashes, which may be caused by visual inattention     (i.e., looking away from the roadway to perform secondary tasks). A driving intervention that     trains teens to reduce instances of looking away from the roadway will be tested in teens     with ADHD.   "
33439|NCT02848079|"     This study will examine the safety and effectiveness of oxaliplatin in combination with     TAS-102 (TAS-OX) for treatment of patients with metastatic colorectal cancer whose cancer has     progressed or recurred after FOLFOX chemotherapy.   "
33440|NCT02848066|"     The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor     biomarker with gastric cancer pts and cancer-free healthy volunteers.   "
33441|NCT02848053|"     Objectives: This study is aimed to assess whether Tianqi Capsule interventions have a     long-term effect on the risk of diabetes and provide evidence that early intervention by     traditional Chinese medicine could delay the progression from impaired glucose tolerance to     diabetes.      Study contents: 1.420 participants were followed up for 8 years to assess the long-term     effect of Tianqi Capsule. Phone-call followed up was applied to investigate the status of     impaired glucose tolerance and orthoglycemic survivors until the end of REDUCES study. 2.To     participants that determined the status of glucose metabolism, a variety of ways were used to     find the evidence of diagnosis of glucose metabolic status, such as glycemia laboratory     sheets from normal hospitals, medical records, the use of antidiabetic drugs or insulin     injection, etc. 3. To participants that undiagnosed the status of glucose metabolism, oral     glucose tolerance test, blood pressure, weight and blood biochemical analysis were performed     to assess the state of glucose metabolism. 4. Questionnaires were given to all the     participants to investigate their condition of treatment, diet, exercise and other lifestyle.   "
33442|NCT02848040|"     Bile acid malabsorption (BAM), a common cause of diarrhoea, affects 1 million people in the     UK, but is often misdiagnosed as irritable bowel syndrome or goes unrecognised in patients     with inflammatory bowel disease.      The SeHCAT (seleno-tauro-homocholic acid) test is currently the only diagnostic test for BAM,     but it is not widely available and it is also time consuming, expensive and involves exposure     to radioactivity. Some clinicians give a course of blind or empirical treatment instead. The     National Institute of Clinical Excellence (NICE) recognised these issues and highlighted the     need for cheaper and safer tests to identify BAM.      This study will assess the accuracy of a simple, convenient and inexpensive laboratory test     for the rapid diagnosis of BAM which measures bile acids in stool. This test has the     potential to have a broad impact on clinical practice and patient care by enabling doctors to     identify and treat patients with BAM promptly. Results from the second phase of the study     will allow the assessment of the benefits of monitoring the stool test to determine whether     the bile acid changes can predict the response to treatment and dosage needed for each     patient.   "
33443|NCT02848027|"     Single-center, lab blinded to include up to 400 subjects with knee osteoarthritis. Collection     of synovial fluid from diseased knee before and after Regenexx®SD treatment will serve as the     experimental condition, i.e. the osteoarthritic knee.   "
33444|NCT02848014|"     The purpose of the study is to determine whether a short psychological intervention aiming at     optimizing expectations is able to foster positive emotions and whether an intervention     inducing positive emotions is able improve participants' expectations. Furthermore, the     investigators will examine whether both interventions are effective in buffering the stress     response after an acute stressor in a healthy sample compared to a control condition.   "
33446|NCT02847988|"     The primary aim of this proposal is to test the effectiveness of neuromuscular electrical     stimulation (NMES) in improving functional status and muscle function in patients receiving     prolonged mechanical ventilation.   "
34491|NCT02834325|"     The purpose of the study was to describe early predictors and to develop a prediction tool     that accurately identifies the need for mechanical ventilation in pneumonia patients with     acute respiratory failure treated with High Flow nasal cannula.   "
33447|NCT02847975|"     Investigators recently showed that tadalafil restores functional sympatholysis in patients     with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD     via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also     be restored by sodium nitrite— which is an indirect nitric oxide donor.   "
38713|NCT02778880|"     This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine     and intranasal fentanyl in children presenting to the Emergency Department with acute     extremity injuries.   "
33454|NCT02847884|"     Crohn's disease (CD) is a lifelong condition of inflammation in the bowel. CD can affect any     part of the gastrointestinal tract from mouth to anus. Symptoms can include: tiredness,     stomach pain, diarrhea (which may be bloody if the disease is severe), fever, weight loss,     skin rashes, arthritis and inflammation of the eye.      Infliximab-IFX (Remicade®) is a medication that is used to treat CD in adults and children.     In adults it has been shown that the amount of this drug a person has in their blood can show     how well it is working for them. Health Canada has approved Infliximab -IFX for the treatment     of CD in children 9 and older. In Canada, doctors may prescribe Inflixmab to younger children     when other therapies do not resolve their disease symptoms. This is called off-label use of     Infliximab.      IFX levels in the body and consequently its efficacy can be influenced by many biological     characteristics within the patient's body. In about 17% of those treated with IFX, the     patient's immune response against IFX may lead to a three to fivefold increased risk of loss     of response. This immune response to the medication often occurs when drug levels are     undetectable in the body. Thus it is in order to achieve best results with this treatment,     physicians need to be able to adjust dosing specific to each patient. A recent study has     shown that 29% of children have an undetectable IFX level at the 4th medication infusion. Up     to 40% of patients receiving scheduled IFX have undetectable drug level prior to their next     infusion.      In order to minimize the loss of response, we hope to conduct an observational cohort study     of pediatric patients treated with IFX.      This open label, cohort study aims to:        1. Determine the pharmacokinetics of IFX in children with CD and the factors that affect          IFX levels during the first three loading infusions        2. Obtain data to create a model that can guide and adjust the IFX dose and frequency to          achieve optimal trough level between 5 and 10 ug /ml at 14 weeks.   "
33455|NCT02847871|"     Loss of mobility is predictive of a loss of autonomy and is often the first sign of     functional decline. Loss of mobility is also associated with poor perceived quality of life,     depressive symptoms, high risk of adverse events such as falls and fractures, to an increased     risk to input in institution and mortality's increase.      Consequences and frequency of loss of mobility make essential its identification, evaluation     and the practice of preventive measures in primary care.      The implementation of effective interventions in primary care to prevent or delay the loss of     mobility is a public health priority.      PRISME-3P program aims to develop and evaluate a dedicated care pathway, in primary care,     based on a personalized multimodal intervention: screening, support combining physician,     teaching exercises by a specialized Monitor in Adapted Physical Activities (MAPA) and     nutritional counseling.   "
33456|NCT02847858|"     Health -E-You is an interactive, individually tailored computer application (App) that was     developed to educate adolescent girls about contraceptive methods and assist them in     selecting a contraceptive method that meets their individual needs. The goal is to reduce     disparities in unintended pregnancy rates among Hispanic adolescent females.      The App was designed in close collaboration with clinicians and Hispanic adolescents.     Health-E You was designed to be used in conjunction with a clinical encounter to prime both     the patient and provider prior to the face-to-face visit to facilitate the discussion and     provision of appropriate contraception. It is founded on key principles of Social Cognitive     Theory.      Through an interactive approach, Health-E-You assesses the users' sexual health risks,     knowledge and contraceptive use history and preferences to facilitate a sense of agency and     self-efficacy around selecting an effective contraceptive method. First, the user selects     their preferred language (English or Spanish) and according to the selected language, the App     provides a brief description of the module and consents the user to participate. It then     assesses sexual health knowledge using an interactive truth vs. myth game. Correct answers to     the truth vs. myth statements are then presented to the user as short, easy-to-read     explanations. Next, the App assesses the user's individual contraceptive needs and     preferences. The user is also screened for possible medical contraindications to     contraceptive methods. Based on the user's input, the App provides individually tailored     messaging and recommendations for contraceptive methods according to the user's own timeline     for childbearing and their lifestyle preferences, past experiences and needs. The     recommendations are presented on a visual continuum of effective contraceptive options based     on desired duration of action and efficacy. Users then have the option to learn more about     the recommended method(s) and they also have the option to learn more about any of the     contraceptive options. Evidence-based contraceptive information is presented in a     user-friendly format that includes YouTube style videos. Users can select to view brief video     vignettes that feature clinicians who provide additional information about the method of     interest and/or videos of diverse young women who discuss their experiences with each of the     contraceptive methods. At the end of the App, adolescents are asked to select the method (s)     they are most interested in using. They are also encouraged to use condoms to protect against     sexually transmitted infections (STIs) and provided information about emergency     contraception. Users can review a summary of a key information gathered from the App and are     offered the opportunity to share that information with their clinician so that the clinician     can better support the adolescent in selecting and using an effective and appropriate     contraceptive method.      The objective of this study is to evaluate the effectiveness of Health-E You on its ability     to address disparities in contraceptive knowledge, access and utilization among Hispanic     adolescents. The long term goal is to reduce the incidence of unprotected sexual intercourse     (and associated unintended pregnancies and STIs) over time. A total of 14 School-Based Health     Centers (SBHCs) affiliated with the Los Angeles Unified School District, will be randomized,     with equal chance, to use the Health-E You App or to provide usual care (without the App). A     total of 1400 Hispanic adolescents will be selected to participate in the study (700 at     intervention clinics and 700 at the control clinics). The investigators hypothesize that     adolescents who use the Health-E You App will have greater sexual health knowledge and will     be more likely to use effective contraceptive than adolescent who do not use the App. The     investigators will also evaluate the effectiveness of the App on its ability to improve the     effectiveness and efficiency of the health visit. Participants will be asked to complete     follow-up surveys immediately following the clinical encounter and at three and six months     after the clinical encounter.      The ultimate goal of this study is address health disparities in the use of effective     contraceptives and ultimately reduce the incidence of unintended pregnancies and STIs among     at-risk Hispanic adolescent girls.   "
33457|NCT02847845|"     The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue     patient.   "
33458|NCT02847832|"     The ability of different methods to discriminate between benign and malignant adnexal masses     has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA logistic     regression model LR2 were superior to RMI and to all other methods for predicting malignancy     in an adnexal mass included in the meta-analysis. However, a fair comparison of methods     requires them to be applied on the same tumor population.      The general objective of this study is to prospectively validate the Simple Rules, ADNEX, the     Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct     comparison of these tools.      IOTA7 is an international multicenter prospective observational study including different     types of ultrasound centers and examiners with different levels of ultrasound experience. In     total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.   "
33459|NCT02847819|"     Total of 100 patients are included in this is a prospective observational study to evaluate     the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing     thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be     compared to post operative ultrasound scans.   "
33460|NCT02847806|"     Sexual steroids administered to supra-physiological doses are likely to change the     carbohydrate and lipid metabolism.      Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic     treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both     steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by     the reference method of the hyperinsulinemic euglycemic clamp.   "
33461|NCT02847793|"     Cognitive biases are a hallmark of depression but there is scarce research on whether these     biases can be directly modified by using specific cognitive training techniques.      The aim of this study will be targeting and modifying specifically relevant attention biases     in participants with subclinical depression using eye-tracking methodologies. This innovative     approach has been proposed as a promising future line of intervention in Attention Bias     Modification procedures (Koster & Hoorelbeke, 2015).      Recent findings suggest that depression is characterized by a double attentional bias (Duque     & Vazquez, 2015), More specifically, depressed individuals have difficulties both to     disengage from negative materials (e.g., sad faces) and to engage with positive materials     (e.g., happy faces). Thus, training procedures to change attentional biases should target     these two separate components.   "
33462|NCT02847780|"     This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel     techniques (causing least discomfort to the patients) for the detection of impaired     vocal-cord movement after thyroid surgery.   "
33463|NCT02847767|"     The high dose per fraction (>10Gy/fraction) used in Stereotactic Ablative Body Radiotherapy     (SABR) has been shown to be more effective at local tumor control than treatments employing     more conventional dose fractions. The mechanisms for this are currently under debate. One     possible mechanism for this increased effectiveness is that high dose/fraction causes     significant vascular damage to the tumor. This study hopes to measure vascular integrity pre     and post SABR treatment using kinetic models obtained from dynamic contrast enhanced CT.   "
33489|NCT02847429|"     This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral     crenolanib versus oral placebo in combination with best supportive care in subjects with     advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120     subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching     placebo orally (PO) 3 times daily (TID) in combination with best supportive care.   "
34492|NCT02834312|"     This dose-finding study is being conducted to select the daily oral dose of estetrol (E4) for     the treatment of vasomotor symptoms (VMS) in post-menopausal women.   "
33464|NCT02847754|"     Standard indications for palliative radiation of bony metastases include pain, spinal cord     compression, and impending pathologic fractures.      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid     complications. Tailored training of the paravertebral musculature may support Radiation     therapy and improve above named factors. DISPO-2 was designed to investigate the impact of     tailored physical exercise in patients with unstable vertebral metastases as compared to     manual therapy (massage etc.). The trial includes patients with painful unstable bony     metastases, patients with spinal cord compression or impending pathological fractures are     excluded. The investigations are carried out in a prospective randomized controlled phase-II     parallel group design.   "
33478|NCT02847572|"     This will be a single center, non comparison clinical trial. Fifty study patients will have     the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their     non-dominant eye. The investigators will be evaluated vision at distance, intermediate and     near as well as assessing patient satisfaction and spectacle independence.   "
33465|NCT02847741|"     Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to     the understanding of SB is a stress vulnerability model, but so far, all scientific works has     no clinical application. The management of psychiatric patients, including depressed     subjects, faces the inability to detect those with a high risk of SB. Many studies have shown     a link between low cholesterol and SB. A study has recently proposed a total cholesterol     threshold below which the risk of suicide could be increased. However, a prospective study is     needed to assess the predictive nature of such an indicator.   "
33466|NCT02847728|"     This is an observational, multicenter study in patients treated with nivolumab for the     approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the     United States (US). Targeted countries in the EU for study participation include Austria,     Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to     assess the safety experience, survival, adverse event management, and outcomes of adverse     events associated with nivolumab in routine oncology care facilities.   "
33467|NCT02847715|"     Improvements in cancer treatment have led to an increasing number of patients being cured or     in remission, but they are followed up to detect recurrence, manage persistent symptoms and     late treatment effects. With growing survivors, traditional hospital follow-up is not     sustainable. New models of follow-up care are needed. This research project aims to develop     and establish the feasibility of introducing a new electronic care pathway/system for remote     monitoring ovarian cancer patients in remission. The project includes a development phase,     followed by a before-and-after study to explore the feasibility of a new pathway/system for     remote monitoring.   "
33468|NCT02847702|"     The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of     VM902A twice daily compared to placebo in subjects with moderate to severe chronic pain due     to OA of the knee.   "
33469|NCT02847689|"     The purpose of this study is to examine whether playing recordings of a mother's voice to her     infant while in the hospital nursery is an effective treatment for promoting healthy brain     and language development in infants born preterm.   "
33470|NCT02847676|"     Our study aims to characterise a possible pluripotent cell population in the abdomen     responsible for peritoneal adhesions. We therefore want to take samples from women undergoing     planned laparoscopic surgery with and without adhesions, isolate the cells and characterise     them for markers of pluripotency.   "
33471|NCT02847663|"     This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after     a muscle damage protocol.   "
33473|NCT02847637|"     This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants     with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or     older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this     population with emphasis on efficacy, safety, and pharmacokinetics.   "
33474|NCT02847624|"     The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in     patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical     setting in Japan.   "
33475|NCT02847611|"     The main objective of this work is to validate the dynamometer LABIN in comparison with the     technique of gold-standard reference JAMAR, in a healthy population.      The infringement of the prehension is frequent and impacts on the social and professional     quality of life of the patients. There are numerous instruments measuring the strength of     prehension. The JAMAR is a mechanical, hydraulic dynamometer, exploring in kilograms the     maximal strength of the prehension. It is at present Gold Standard for the measure of the     strength of prehension. There is for the moment no electronic known instrument exploring the     endurance of the strength of prehension during an effort of tightening. This parameter would     indeed be interesting for the exploration in geriatrics and in the neuromuscular pathologies.      This study justifies itself by the fact that the dynamometer LABIN should allow the     evaluation of the muscular endurance of the strength of hand as complement of the peak of     strength   "
33476|NCT02847598|"     The primary purpose of the study is to evaluate the efficacy of BIIB059 in reducing disease     activity in participants with systemic lupus erythematosus (SLE) with active cutaneous     manifestations and joint involvement (Part A), and in participants with active cutaneous     lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE,     including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part     B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in     reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of     BIIB059 (Parts A and B).   "
33487|NCT02847455|"     Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a     randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into     three groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of     ilaprazole, 5, 10 mg/day, and one of Rabeprazole 10 mg/day as positive control. The primary     endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its     resolution from active to scarring stage. Symptoms relief was evaluated as secondary end     points by using a graded score. Safety and tolerability were evaluated on basis of clinical     assessments.   "
33477|NCT02847585|"     Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children.     Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10     (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has     shown significant health benefits in adult patients with cardiovascular disease, it is worth     studying water-soluble coenzyme Q10 supplements to evaluate their potential role as     complementary therapy for PDCM. The purpose of this study is to explore the potential role of     water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will     recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between     coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection     fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant     enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation     (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble     ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the     quality of life of PDCM patients by questionnaire. Through this study, we expect to     demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and     will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac     function and reduce inflammation, and further reduce the rate of heart transplantation and     increase quality of life in PDCM.   "
34450|NCT02834858|"     Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This     study intends to establish an optimal clinical research program, and attempts to break the     technical bottleneck in the stem cell therapy for treating diabetes related vascular     complications.   "
33479|NCT02847559|"     The purpose of this research study is to determine the effects bevacizumab (the study drug)     combined with Optune (the study device) tumor treatment field therapy has on meningiomas.     Bevacizumab is considered investigational because the US Food and Drug Administration (FDA)     has not approved its use for the treatment of meningiomas. The study drug is a medication     that blocks the growth of new blood vessels. It is thought that the study drug may interfere     with the growth of new blood vessels and therefore might stop tumor growth, and possibly     shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood     vessels. Optune is also considered investigational because the US FDA has not approved its     use for the treatment of meningiomas. Optune is a device that the patient will wear and use     for at least 18 hours of each day. It delivers alternating electrical current to the     patient's brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to     occur in order for cell division to occur and allows tumors to grow. By slowing this process,     we hypothesize that meningioma growth may also be slowed.   "
33480|NCT02847546|"     The primary objective of this study is to collect data to confirm the performance and safety     of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in     the preparation for Transcatheter Aortic Valve Implantation (TAVI).   "
33481|NCT02847533|"     This study focuses on blood inflammatory markers (pro-inflammatory cytokines,     anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant     unipolar depression in comparison with non-resistant unipolar depressed patients.   "
33482|NCT02847520|"     If the addiction to games of chance and gambling is a disease of increasing knowledge, the     emergence of poker rout evaluation procedures, prevention and treatment usually offered to     players in need. In the case of poker, which unlike other games has a real part to address     and which damages are expressed differently, the evaluation can not be done identically to     other games. This problem has often been emphasized in the literature, in particular the lack     of specific tools for the identification of poker gambling problems. Thus, the fact of     developing a specific evaluation tool could allow poker to take into account the specificity     of poker among other games. This would be part of the evaluation complement batteries     currently available to players in general by offering a specific tool, and secondly to allow     the assessment of the aspects of the problems often absent for other games . The goal here is     to develop and validate a specific tool detection of problem gambling in the particular     context of poker.   "
33483|NCT02847507|"     Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France     in 2016.   "
33484|NCT02847494|"     This is an emergency department based randomized trial in which we compare two different     treatment for migraine headache. The goal is to decrease the number of headache days during     the week after ED discharge.   "
33485|NCT02847481|"     This is a randomized pilot study to characterize engraftment of a donor's microflora onto     patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota     transplantation.   "
33486|NCT02847468|"     Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with     inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has     both antiangiogenic and antiproliferative effect, is the only therapeutic with proven     survival benefits. However, the efficacy of Sorafenib remains inconstant with a media overall     survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the overall     incidence of treatment-related adverse event is 80%. Thus, it appears essential to find an     early and accurate way to determine which patients are best responding to therapy in order to     avoid the toxicity and cost of ineffective therapy.      Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited     performance in the setting of HCC because of lack of sensitivity, in particular for     well-differentiated tumours. However FDG uptake is related to proliferation rate and is an     efficient marker survival following liver transplantation and selective internal radiation     therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static     scan provides better characterization of the tumour by adding information on tumour     perfusion.      FCH which reflects lipids metabolism and specifically choline kinase activity, has shown     promising results for detection of HCC when compared with FDG alone. Moreover, choline     activity is related to a kinase pathway in mammalian cells, which is specifically inhibited     by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour     differentiation, by opposition to FDG. Therefore, several studies have suggested that     combined evaluation of tumour glucose and lipid metabolism could play a complementary role     for the evaluation of HCC in the setting of detection, staging and to predict recurrence     following surgical resection. Thus, the investigator hypothesize that the combination of FDG     and FCH may be the most accurate imaging evaluation of HCC.      Thus the aim of the present study is to determine the predictive performance of survival of     lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with     advanced HCC.   "
33488|NCT02847442|"     The purpose of this study is to evaluate the change in subject's condition according to the     Investigator's Global Assessment of Change after three months of treatment with 50 mg     opicapone once daily in a heterogeneous patient population reflecting daily clinical     practice.   "
45093|NCT02695420|"     - To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart     failure (HF) with reduced ejection fraction; - To evaluate the safety and tolerability of     oral omecamtiv mecarbil   "
33490|NCT02847416|"     the aim of this study are to explore the characteristics of mean airway pressure, oscillatory     amplitude and power spectral density (PSD) of oscillatory airway pressure that generate by     various loaded and flow rate during expiration and inspiration in healthy subjects and to     explore the best loaded and flow rate for airway secretion clearance using the BreatheMAX®     device   "
33491|NCT02847403|"     The overall objective of the study is to assess the potential effects of the long-acting     GLP-1 analogue exenatide in preventing/slowing the progression of cognitive dysfunction and     related biomarkers in dysglycemic/prediabetic patients with mild cognitive impairment (MCI).   "
43796|NCT02712398|"     The objective of this study is to collect additional data on safety, performance and     effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia     repair at high risk for surgical site occurrence (SSO).   "
33493|NCT02847377|"     The development of biomarkers will lead the dynamic of personalized medicine and fill the     unsatisfied needs in oncology for prediction of therapeutic response.      Molecular imaging enables non invasive quantification of biomarkers. The development of     molecular imaging biomarkers is closely related to the development of therapeutic molecules.     Among the potential targets, kinases offer a lot of advantages: (i) they play a central role     in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in     biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic     (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic     indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the     most sensitive and dedicated to evaluate small molecules. However few radiotracers are     available and their specificity limits their clinical use. The IMAkinib® approach is an     innovative method proposed to develop new PET radiotracers adapted to current medical and     economical challenges.      The epidermal growth factor receptor (EGFR) is an established target for the treatment of     advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs)     Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved     for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19).     Unfortunately the majority of patients will develop a resistance to the TKI in the long term     (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients     (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool     to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators     have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated     ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine     the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound     is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.   "
33494|NCT02847364|"     The purpose of this study is to determine whether chewing gum post-operatively decreases the     time to first flatus or defecation in patients undergoing spine surgery as a indirect     indicator of post-operative ileus.   "
33495|NCT02847351|"     The study aimed to investigate whether an Arabinoxylan-enriched crackers consumption for 4     weeks in overweight and obese patients without diabetes mellitus have specific healthy     effects on glycemic control (reduction of homeostatic model assessment -HOMA index-).     Furthermore, study evaluated the effects of Arabinoxylan on insulin, lipid and Ghrelin.   "
33496|NCT02847338|"     High blood pressure (Hypertension) is extremely common and is a major cause of heart disease,     kidney disease and stroke. One in three of the UK (United Kingdom) population will require     treatment for hypertension at some point in their lives. A healthy lifestyle alone is often     not enough to control blood pressure, and drug treatment is usually required. Although a wide     variety of drugs are available to treat hypertension, choosing the right kind of tablet or     combination of tablets for individual patients is a problem, and therefore many people have     poor blood pressure control.      Hypertension treatment within the UK is currently selected according to age and self-defined     ethnicity (SDE). There are limitations to this approach which include wide variability in the     response to hypertension drug classes between people. There is also uncertainty about     selecting hypertension drugs for ethnic minorities other than those of African/Caribbean     ancestry, for example, South Asians because of a lack of information from trials. In the AIM     HY-INFORM study the investigators are looking to recruit equal number of black/caribbean,     south asian and white european participants to be able to compare differences in hypertension     treatments and ethnicity.      The primary objective of this study is to determine if the response to antihypertensive drugs     differs by self defined ethnicity.   "
33497|NCT02847325|"     AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits     Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in     inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte     activation (predominantly B-cell activation) in the preclinical studies. The nonclinical     program has demonstrated that AC0058TA has the potential to interfere with signaling     functions mediated by tyrosine kinases and may be useful for controlling excessive or     aberrant T- and B-cell activation in autoimmune diseases.      As an investigational targeted therapy for RA and SLE, AC0058TA is expected to address the     unmet need of this patient population, for whom there are currently no effected therapies and     there is a great unmet medical need, AC0058TA may inhibit the key pathway which involves the     disease process.   "
33498|NCT02847312|"     In this proposed human trial, the investigators aim to establish whether 4 weeks of daily     consumption of beta-glucan matched meals providing either a high dose or a moderate dose of     oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in     markers of CVD risk and gut health relative to an energy matched control intervention in     healthy adults with above average blood pressure.   "
33499|NCT02847299|"     The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance     techniques requiring no equipment other than the volumetric fan. The two methods are     air-stacking and hyperinflation .      The study is a Cross-over, monocentric and open label study   "
33501|NCT02847273|"     Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures     regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a     normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at     the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new     4-wavelength generation of NIRS monitors which could reliably assess real-time absolute     values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2     values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the     new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.   "
33502|NCT02847260|"     The purpose of the study is to evaluate the safety and tolerability of a rapid dose titration     regimen of subcutaneous Remodulin® therapy in patients with PAH.   "
33510|NCT02847156|"     Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data     mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young     children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF     children are rare and the impact of most frequent viruses such as human rhinoviruses is     usually not correctly evaluated.      The aim of this study is to assess the frequency of lower and upper RVI during a 1 year     follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and     therapeutic level.      Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the     short term and without any particular link with a specific virus as previously described.   "
33503|NCT02847247|"     Purpose: The purpose of this study is to classify volunteers as endotoxin-responders or     non-responders following inhalation of 20,000 EU Clinical Center Reference Endotoxin (CCRE).     Endotoxin is a commonly encountered bioaerosol and component of indoor and outdoor air     pollution. For reasons that remain unclear, some individuals appear to be more susceptible to     the inflammatory effects of inhaled endotoxin than are others, possibly owing to single     nucleotide polymorphisms in the Toll-like receptor 4 (TLR4) gene that influence TLR4     signaling and function. These susceptible individuals represent a population of particular     interest for further mechanistic studies of the effects of endotoxin and for therapeutic     trials. Susceptibility to inhaled endotoxin will be determined by measuring change in     peripheral blood neutrophil counts, a biomarker of systemic inflammation, following inhaled     CCRE. In our previous work, the investigators have found that inhalation of 20,000 EU CCRE is     well tolerated and induces measurable increase in neutrophil content of peripheral blood in     susceptible individuals. Our hope is that this CCRE inhalation protocol can be employed to     screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.   "
33504|NCT02847234|"     Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or     dental infections. The infection can rapidly descend into the mediastinum and lead to a     life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive     care with radiologist and with early and repeated surgical debridement. Anti-inflammatory     drugs have been incriminated by authors in the development of necrotizing fasciitis.     Recently, a single-center study demonstrated that pharyngeal source of CNF and oral     glucocorticoid intake before admission was associated with the occurrence of mediastinitis.      The aim of the study is to assess the incidence and factors associated with CNF     complications, in particular mediastinitis. Secondary outcome is to describe patient     characteristics, medical and surgical management.      Methods: A retrospective, observational, non-interventional multicentre study is conducted in     nine intensive care units in France from January 2005 to December 2016.   "
33505|NCT02847221|"     Successful weaning from mechanical ventilation in ICU patients depends on patient ability to     breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow     (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a     dedicated flow-meter that required patient disconnection from the ventilator, limiting the     generalizability of this procedure. This study aimed to predict extubation outcome in a     consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF     measurements were done by freezing ventilator screen and scrolling the cursor to the maximal     value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.      The objective was to assess the performance of CPF to predict early extubation outcome.   "
33506|NCT02847208|"     Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis     (CF). Only few studies have described contraceptive practices in cohorts of CF women.      The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon     adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire     about their contraceptive choices, frequency of gynaecological follow-up and cervical     screening. Other clinical data were collected from the CF adult centre registry.      One hundred and twenty women (100%) answered the questionnaire, among whom two were     post-menopausal (46 and 59 years of age), and five were pregnant.      Seventy-four per cent of the women declared they had undergone gynaecological followup (89%     of the women with transplantation), and only 55% reported having at least one previous Pap     smear test. Among the transplanted patients, only 58% had had a Papsmear test, despite     immunosuppressive treatment. The overall rate of contraception was only 64% and in diabetic     women, it was 61%. Among contraception users; 65% used oral contraception, predominantly     combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only     contraception. Intrauterine device accounted for 10% of patients using contraception, and     tubal ligation only 4%.      This study is limited by its cross-sectional design. Despite an internal validation of the     questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken     into account.      This study of practices highlights the importance of improved information regarding     sexuality, fertility and reproductive health in young women with CF. A regular gynaecological     follow-up and cervical screening is mandatory in this population.      Better gynaecological care and contraceptive advice would help to avoid unplanned     pregnancies, and optimize contraceptive selection in relationship to specific clinical     conditions.   "
33507|NCT02847195|"     Assess the depth of sedation and analgesia in pediatric intensive care is critical to the     management of intubated patients under mechanical ventilation. The responsiveness of the     pupil is changed by the sedation and analgesia. Measuring the pupil diameter is proposed in     anesthesia and intensive care to assess the quality of analgesia in adult population.     Visually measuring the diameter of the pupil remains very imprecise, but this measure can be     accurately and quickly performed thanks to portable devices called Pupillometers. Some     devices including Algiscan® device (IdMed ) can measure in addition to the pupil diameter,     the variation of pupil diameter, the latency of the pupillary reflex and the maximum speed of     contraction. Pupillometry was tested in adult ICU patients, during painful and painless     procedures [1]. In this study, pupillometry was more sensitive for detecting pain compared to     the change in heart rate or bispectral index. The objective of this work is to perform     measurements of pupil diameter during painful procedures (e.g. tracheal aspiration) in PICU.     In parallel we will continue using the Comfort B-scale (has been validated for assessment of     pain in children admitted to a pediatric intensive care unit [2-5] and compare the results of     both types of assessment pain.   "
33521|NCT02847013|"     This present investigation aims to determine whether a transversus abdominous plane(TAP)     block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section     decreases post-operative pain. The hypothesis is that performance of the TAP block with     liposomal bupivacaine will decrease post-operative narcotic use.   "
33741|NCT02844153|"     Metformin is the most widely prescribed oral treatment for diabetes, and the only one that     showed a survival benefit.      Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney     disease (CKD) patients.      The aim of the study is to describe the use and side-effects of metformin in CKD patients in     routine practice.   "
33508|NCT02847182|"     This is a single site, prospective, randomized, double-blind study of a single intravenous     autologous or allogeneic, unrelated cord blood (CB) infusion in children ages 2-7 years with     Autism Spectrum Disorder (ASD). Participants will be randomly assigned to Sequence A,     consisting of a single infusion of CB cells at baseline followed 6 months later by a single     infusion of placebo, or Sequence B, consisting of an infusion of placebo at baseline followed     6 months later by an infusion of CB cells. All participants will ultimately be treated with     CB cells at some point during the study. Participants with an available qualified autologous     CB unit will receive autologous cells, and those without a suitable autologous CB unit     available will receive cells from a ≥4/6 HLA-matched, ABO-matched allogeneic, unrelated donor     CB unit from the Carolinas Cord Blood Bank. All infusions will be double-blinded. The primary     outcomes will be assessed 6 months after the initial infusion in the sequence. Additional     testing for secondary exploratory analyses will be performed at 12 months. Duration of study     participation will be 12 months from the time of baseline infusion.   "
33509|NCT02847169|"     The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric     and ocufilcon D toric contact lenses after 1 week of wear in each pair.   "
33512|NCT02847130|"     This research study seeks to identify, understand, and overcome barriers to the use of     clinical practice guidelines by pediatric oncology healthcare providers The treatments for     childhood cancers are intense and result in a high rate of symptoms which require support by     healthcare providers. By reviewing patients' medical chart records, meeting in focus groups     and in one-on-one interviews, healthcare providers may improve how clinical practice     guidelines are used to support children undergoing cancer treatment.   "
33513|NCT02847117|"     Mastiha is a natural product from the tree Pistacia lentiscus var. Chia (Anacardiaceae)     growing exclusively in the Southern part of Chios Island. It is the natural resinous exudate     produced after longitudinal incisions made at close intervals from the base of the trunk up     to the thicker branches of the tree. U.S. Food and Drug Administration has classified Mastiha     as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory,     antimicrobial and antioxidant properties. In addition, the European Medicine Agency has     recently recognized Mastiha as a natural medicine and classified it to the category of     traditional herbal medicines in diarrhea problems, mild dyspeptic disorders, skin     inflammation and healing (EMA/HMPC/46758/2015).      However, the bioavailability of its microconstituents in human biological samples is still     undetermined. To this end, the current study aims to investigate the whether Mastiha's     compounds are bioavailable in healthy adults. Twenty apparently healthy men, aged 20-40 years     old, will be enrolled based on certain inclusion and exclusion criteria. The staff of the     study will provide detailed information regarding the aims, the methods, anticipated benefits     and potential hazards of the study and all patients will receive the Patient Information     Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether they want to     participate in the protocol. Each patient agreeing to participate will sign an Informed     Consent document and the staff will explain to patients that they are under no obligation to     enter the trial and that they can withdraw at any time during the trial, without having to     give a reason. A copy of the signed Informed Consent will be given to the participant.      After enrollment, the volunteers will undergo a medical and dietary assessment and their     health status will be evaluated through a complete blood count. Then, they will follow a     low-phytochemical diet for five days, meaning that they will exclude fruits, vegetables,     legumes, coffee, tea, alcoholic beverages and chocolate. On the day of the experiment and     after overnight fasting, the volunteers will consume 10g of natural Mastiha and blood samples     will be obtained on timepoints 0h, 30min, 1h, 2h, 4h, 6h and 24h after Mastiha intake. Until     timepoint 6h, they will be allowed to consume only water. Urine samples will also be     collected on timepoints 0h, 4h, 8h and 24h.      After collection, the phenolic and terpenoid content or metabolites of Mastiha will be     identified in plasma samples applying LC-HRMS. Additionally, the metabolomic profile will be     assessed in plasma samples with LC-HRMS and in urine samples with NMR-based metabolomics.     Oxidative stress will be evaluated through the CuSO4 technique and oxidised LDL levels in     serum samples, as well as F-2 isoprostanes in urine samples.   "
33514|NCT02847104|"     Intensive care unit (ICU) patients commonly display hyperglycemia, even without previously     known diabetes. It was demonstrated that hyperglycemia was associated with increased hospital     mortality in various medical and surgical ICU situations. However, discrepant results from     recent randomized, clinical trials of tight blood glucose control in ICUs have not allowed     conclusions regarding whether there is a causal link between hyperglycemia and ICU mortality.     In addition to the mean blood glucose level, glucose variability has recently been emphasized     as an independent predictor of ICU and hospital mortality. This concept has been described in     a wide variety of medical, surgical and trauma ICU patients. In all of these settings,     glycemic variability was measured with various indices but was steadily associated with ICU     and/or hospital mortality in non-diabetic ICU patients. Conversely, glycemic variability was     either weakly or not associated with mortality in ICU patients with previously known     diabetes. Notably, all of these data have been observational, and interventional trials     remain lacking to assess the impact of glycemic variability reduction on ICU mortality and     thus to demonstrate causality. However, glycemic variability was considered sufficiently     important to be mentioned in recent international guidelines for the management of     hyperglycemia in critically ill patients. In these publications, experts from the American     College of Critical Care Medicine emphasized that glycemia should be maintained at less than     9.9 mmol/L in ICU patients while avoiding hypoglycemia and minimizing glycemic variability.     To achieve these goals, computer-based insulin infusion protocols have demonstrated their     superiority to paper-based protocols. Glucose concentrations, variation per unit of time     between the last and current glucose measurements, insulin dosage, and carbohydrate intake     were the main input variables used in these different computerized algorithms. However, such     protocols are not widely available because commercial systems have licensing fees and     academic protocols do not always go beyond the pilot phase.      To address this issue, the investigators adapted a previously validated, paper-based, dynamic     protocol (DP) to an actual recommended glycemic target range. Our aim was to assess the     efficacy, safety, feasibility and acceptance by nurses of this dynamic insulin protocol,     compared to a paper-based, sliding scale static protocol (SP).   "
33515|NCT02847091|"     The objective of this study is to assess the reduction in insulin dose from baseline at Week     24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when     ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes     mellitus receiving insulin therapy.   "
33516|NCT02847078|"     The purpose of the study is to investigate the effects of smart phone app on the secondary     prevention for patients with coronary heart disease post percutaneous coronary intervention.   "
33517|NCT02847065|"     In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes.     E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia.     In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public     health, causing increased mortality, particularly in the elderly, and an increase in the     average hospital stay. However, few studies have specifically concerned with the criteria     associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally,     improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E.     coli has importance in terms of public health and is a prerequisite to the development of     preventive strategies and to improve the short-term prognosis.   "
33518|NCT02847052|"     IL-22 is an IL-10 family cytokine that plays major actions to increase intestinal epithelial     barrier function and regeneration during experimental colitis. IL-22 binding protein is a     small, soluble, and secreted protein potently inhibiting IL-22 actions through preventing the     binding with IL-22 Recepteur. This study aims at characterizing how IL-22 binding protein is     regulated in Inflammatory bowel disease to better understand the way IL-22 acts on epithelial     cells during flares of the disease.   "
33519|NCT02847039|"     The research project aims to try to answer the many questions raised by the identification of     new early repolarization syndrome. The questions are varied with both taking optimal clinical     management of patients, the frequency and significance of this anomaly in the population on     the electrophysiological and molecular basis responsible for this electrocardiographic     abnormality.      To try to answer these many questions, the approach will be twofold: clinical and genetic.        -  Establishment of a clinical database containing information of patients who have been          identified as carriers of the anomaly based on the initial clinical presentation in          order to determine their prognoses.        -  Physiological approach will be based on a molecular approach to identify genetic          abnormalities may be involved in this syndrome.        -  200 asymptomatic patients and an unlimited number of patients who presented syncope or          aborted sudden death will be included.      A blood sample (15 ml) will be performed at inclusion.   "
33520|NCT02847026|"     This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine     (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of     fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and     fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will     also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be     evaluated.   "
33574|NCT02846324|"     This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF     subjects will be randomized to receive GBT440 or Placebo orally daily.   "
33522|NCT02847000|"     Patients with pancreatic cancer which has stopped responding to one or more chemotherapy     drugs are asked to take part in this study. The study hopes to find out whether decitabine,     the drug being studied, will have an effect on pancreatic cancer. The decitabine is being     given at a lower dose than its approved use. It is also being given with another drug,     tetrahydrouridine (THU), to improve the exposure of your pancreatic cancer cells to     decitabine.      The purpose of this study is to determine if the drug combination of decitabine and     tetrahydrouridine can recognize a certain DNA target in your cancer. All cells have DNA     within them, and tumor cells have abnormal DNA.   "
33523|NCT02846987|"     The purpose of this study is to test any good and bad effects of the study drug called     Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects.     Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the     cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved     and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast     cancer, lymphoma, and lung cancer.   "
33524|NCT02846974|"     Pulse oximetry is a vital tool in the rapid and non-invasive assessment of emergency     patients, providing a continuous estimate of hemoglobin saturation in arterial blood.     Unfortunately, the costs of these devices are prohibitive and reduce availability in smaller     centres and poor countries, putting millions of patients in danger of easily treatable and     preventable conditions. With current rapid prototyping technologies such as 3D printing, it     is possible to create a very inexpensive pulse oximeter that meets or exceeds the gold     standard. The goal of this study is to develop, validate and certify a pulse oximeter that     measures hemoglobin, carboxyhemoglobin and methemoglobin. This pulse oximeter will be     certified with Health Canada, and then released under the Open Hardware License (OHL), such     that hospitals and ministries of health in rural and impoverished communities in Canada and     internationally would have easy access to these devices.   "
33525|NCT02846961|"     The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar     CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately     to severe inflammatory bowel disease.   "
33526|NCT02846948|"     The aim of the study is to identify the diagnostic value of the focused assessed     echocardiography protocol (FATE - Holm et al 2012) for patients undergoing urgent abdominal     surgery and having signs of sepsis. The extended cardiac monitoring may affect patient's     management during perioperative period. The investigators expect that the incidence of     hemodynamic instability will be reduced and the outcomes of the patients will be improved.   "
33527|NCT02846935|"     The purpose of this study is to evaluate how well the study drug works and safety of oral     decitabine in patients with refractory or relapsed lymphoid malignancies. The decitabine is     being given at a lower dose than used for its approved use. It is also being given with     another drug, tetrahydrouridine (THU), to improve the exposure of lymphoma cells to     decitabine.   "
33528|NCT02846922|"     To evaluate the efficacy of catheter ablation and rate control in heart failure patients with     atrial fibrillation.   "
33529|NCT02846909|"     Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be     lost in the second trimester, which is much lower than in the first trimester. Once a     pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.      Congenital fetal abnormalities and maternal anatomic factors as immunologic factors,     infection, and thrombophilia should be considered; however, a reason and its result     connection may be difficult to be established.      Cervical incompetence means that the cervix is weak and unable to remain closed during the     pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in     maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to     ascending infection may be more important.      Cervical cerclage is performed usually in women with a history of mid-trimester abortion or     spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing     recurrent loss.      Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians     despite the absence of a well-defined population for whom there is clear evidence of benefit.     Furthermore, there is little consensus on the optimal cerclage technique and timing and type     of suture placement.      The Progesterone is known to have an inhibitory action on uterine contractility and is     thought to play a main role in the maintenance of pregnancy until term. Progesterone is also     able to modify the ultrastructural organisation of the myometrium by inhibiting the gap     junctions, and preventing muscular contraction.      Different routes of administration of progesterone have been described in the literature.     These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and     daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.      A recently published Cochrane review further confirmed the beneficial effects of progesterone     in infant health following administration in women considered to be at increased risk of     preterm birth due either to past history of preterm birth or when a short cervix was     identified on ultrasound.      However; most of these published studies have been conducted to test the effect of     progestational agents for the prevention of preterm labor not miscarriage.      Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler     ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth     retardation and fetal anemia, and it plays an important role in managing of these conditions   "
33530|NCT02846896|"     PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental     pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking.     Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of     diseases. In addition, the investigators study will be the first one carried out in the     country on PBC, and therefore will raise disease awareness and create a network.   "
33531|NCT02846883|"     This project is to determine the safety and explore the effectiveness of allogeneic (not     cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in     decreasing inflammation and possible enlargement of the participants' abdominal aortic     aneurysm. Participants will be selected as a possible subject because of an abdominal aortic     aneurysm discovered on the ultrasound or computed tomographic (CT) scan requested by the     participants' doctor.      The purpose of this study is to collect information that will be used to determine if MSCs     can be used to decrease inflammation and possibly slow down enlargement of the participants'     aneurysm. The investigators will also be collecting blood samples to study special     inflammatory cells that cause aneurysms as well as asking participants to have a PET     (positron emission tomography) scan that can measure inflammation directly in the     participants' aneurysm.   "
33532|NCT02846870|"     This randomized clinical trial studies how well visually enhanced education works in     improving prostate cancer and treatment knowledge in patients with prostate cancer that has     not spread to other places in the body. Visually enhanced education includes pictures,     drawings, and photos, may help doctors better convey information about radiation and prostate     cancer to patients.   "
33742|NCT02844140|"     Dose distribution calculations for proton therapy are more accurate when based on DE-CT than     on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations     is for lung cancer patients.   "
33533|NCT02846857|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates     glucose levels through the infusion of two hormones: insulin and glucagon.      The objective of this study is to compare, in a randomized multicenter trial, the     effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented     pump therapy with low-glucose suspend in regulating day-and-night glucose levels in     outpatient settings for 15 weeks in adolescents and adults.      The investigators hypothesize that dual-hormone closed-loop will reduce time spent in     hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective     than sensor-augmented pump therapy with low-glucose suspend.   "
33534|NCT02846844|"     In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3)     Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and     Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform     Training (Experimental).   "
33535|NCT02846831|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy regulates     glucose levels through the infusion of two hormones: insulin and glucagon.      The objective of this study is to compare the effectiveness of single-hormone closed-loop,     dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in     regulating day-and-night glucose levels in adults with T1D for 2 weeks in outpatient     settings.      The investigators hypothesize that dual-hormone closed-loop will increase the percentage of     time of glucose levels spent in the target range in adults compared to single-hormone     closed-loop, which in turn will be more effective than sensor-augmented pump therapy.   "
33536|NCT02846818|"     Impaired cerebral function remains an important complication of cardiopulmonary bypass (CPB)     during cardiac surgery. The aim of the present study is to investigate whether the lactate to     pyruvate (LP) ratio obtained by microdialysis (MD) of the cerebral venous outflow reflects a     derangement of global cerebral energy state during cardiopulmonary bypass.   "
33537|NCT02846805|"     The purpose of this study is to investigate to what extent IOs improve the functionality of     edentulous patients and changes in quality of life and overall patient satisfaction following     treatment with IOs.   "
33539|NCT02846779|"     The purpose of this study is to evaluate three pharmacist-outreach strategies for improving     adherence to insulin among individuals with diabetes. The three approaches are     equivalently-priced but vary by degree of targeting and intervention intensity.   "
33540|NCT02846766|"     This is a two center, open label, non-randomized Phase II study of lenvatinib in adult     subjects with recurrent or refractory advanced cancers with aberration(s) in FGF/FGFR     signaling. Treatment will consist of daily oral administration of Lenvatinib in 28-day     cycles.   "
33541|NCT02846753|"     A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for     the treatment of pulmonary regurgitation with or without stenosis in patient with native     outflow tracts.   "
33542|NCT02846740|"     This pilot study aims to investigate whether a treatment called cranial electric stimulation     or CES can decrease risk factors for suicide. The specific CES device we will use is called     Alpha-Stim®. CES will be used in addition to usual treatment (medication and group therapy).   "
33543|NCT02846727|"     The purpose of this study is to determine if fluorescence angiography can detect occult shock     (hypoperfusion).   "
33544|NCT02846714|"     The overall purpose of this study is to test the feasibility, acceptability, and preliminary     efficacy of a family-focused behavioral intervention (FLARE, which stands for Family     Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive     behaviors among children at elevated risk for the disease.   "
33545|NCT02846701|"     The primary purpose of this protocol is to evaluate the lowest plasma concentration (ie     before the daily taking dose of duloxetine) in patients relieved of at least 30% of their     neuropathic pain with duloxetine treatment.      The secondary purpose of this protocol is to determine plasmatic concentration peak (ie 6     hours after taking duloxetine) in patients relieved of at least 30% of their neuropathic pain     with duloxetine treatment.      Others secondary purposes are to evaluate the intensity of neuropathic pain, to assess the     degree of pain relief and to evaluate the sensation of the global improvement experienced by     the patient.   "
33546|NCT02846688|"     To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal     Mucosa.   "
33547|NCT02846675|"     it's a self-control, double blind study of autologous adipose-derived stromal vascular     fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under     IRB-approved protocol in a feasibility and safety study.   "
33548|NCT02846662|"     Background: Depression is a usual comorbid event associated to chronic diseases, such as     hypertension and diabetes, constituting an important public health problem, with negative     consequences for patients' quality of life and self-care, as well as for compliance with     medical treatment. In low and middle income countries depression is often unrecognized and     untreated, and there is a lack of human resources to treat depression and other mental     problems in these health care systems.      Aim: The present study aims to test a 6 week low-intensity psychological intervention     (CONEMO) delivered via an applicative for smartphones for people with depressive symptoms and     co-morbid diabetes and/or hypertension recruited in primary health care units, in São Paulo     (Brazil).   "
33575|NCT02846311|"     The rapid and accurate detection of influenza virus in respiratory specimens is required for     optimal management of patients with acute respiratory infections. Because of the variability     of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of     influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza     diagnostic tests have been developed such as the Alere i Influenza A&B isothermal nucleic     acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza     A&B assay in comparison with the routine Xpert Flu/RSV assay.   "
45132|NCT02694900|"     The objective of this pilot study was to compare the manual chest compressions (CC) versus CC     feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric     cardiopulmonary resuscitation   "
33549|NCT02846649|"     The objective is to determine feasibility and acceptability of a text message (SMS)-based     relapse prevention intervention as measured through: (1) study retention and SMS query     completion rates and (2) participant ratings of PIER1 interest, perceived efficacy, and ease     of use. Methods: A mixed methods study of adult (age >=18) ED patients who seek treatment for     opioids and have evidence of dependence based on Rapid Opioid Dependence Screen (RODS) score     of >3 and are being discharged to outpatient (community) resources. All participants receive     standard of care in the ED, complete a baseline web survey, are asked to text with us for at     least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone call     between day 8 and 14. Investigators expect preliminary findings to support a relapse     prevention intervention delivered through SMS. Based on feedback from this mixed methods     study, investigators plan to test a refined SMS program in a randomized trial.   "
33550|NCT02846636|"     The main objective of this study is to evaluate the 10 year performances of Mpact cup in     total hip arthroplasty.   "
33551|NCT02846623|"     The goal of this clinical research study is to learn if atezolizumab and obinutuzumab (either     with or without ibrutinib) can help control CLL. The safety of this drug combination will     also be studied.   "
33553|NCT02846597|"     The appropriate pressure and duration needed for sustained lung inflation in preterm infants     at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating     two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds,     during the application of sustained lung inflation in the resuscitation of preterm infants     with respiratory distress in the delivery room.   "
33554|NCT02846584|"     The main purpose of this study is to explore the sequential therapeutic effect and evaluate     the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of     relapse/refractory B cell malignancies.   "
33556|NCT02846558|"     This is a pragmatic, single-blinded randomized trial of improving adherence to dietary     interventions in patients with MS who are receiving monthly natalizumab infusions.   "
33557|NCT02846545|"     The primary purpose of this study is to determine if golimumab can preserve beta-cell     function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).   "
33558|NCT02846532|"     The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic     (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy     administered to pediatric participants 2 to 8 years of age with single ventricle physiology     who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to     evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched     to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid     (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for     thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle     physiology who have completed the Fontan procedure within 4 months prior to enrollment.   "
33559|NCT02846519|"     The purpose of this study is to evaluate the pharmacokinetics of intranasally administered     esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to     evaluate the effects of rifampin on the pharmacokinetics of intranasally administered     esketamine in healthy Caucasian participants.   "
33560|NCT02846506|"     The purpose of this study is to evaluate bioequivalence of the metformin component of the     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet     co-administered with canagliflozin in healthy fed and fasted participants.   "
33561|NCT02846493|"     This prospective, randomized, controlled clinical trial will evaluate the effect and security     of dexamethasone prevention for Patients of Ovarian Hyperstimulation Syndrome.   "
33562|NCT02846480|"     To find out the effectiveness of physical therapy associated with the surgical treatment over     the simptoms and quality of life in III and IV grades of pelvic organ prolapse, patients will     be randomly assigned to one of these groups: experimental group: pre-surgical and     post-surgical physical therapy + behavioral education + surgical therapy. Control group:     surgical treatment + behavioral education.      In both groups several physical therapy assessments will be undertaken: 1st before surgery;     2nd immediately after surgery; and after 6 weeks, 3th, 6th, 12th and 24th months     post-surgery.   "
33563|NCT02846467|"     The aim of this study is to evaluate the comprehension of the Informed consent with the     Standard Verbal Communication (SVC) versus Portable Video Media (PVM).   "
33564|NCT02846454|"     This proposed randomized, double blinded 12 week crossover human feeding study aims to     investigate the effects of consuming a composite drink of inulin and arabinoxylan on satiety     by measuring appetite biomarkers such as subjective satiety, energy/food intake and changes     in the human gut microbiota in healthy weight males (22 to 24.9kg/m2)   "
33565|NCT02846441|"     Post-hepatectomy liver failure is one of the most feared complications by hepatic surgeons.     When size of the future liver remnant (FLR) is regarded to be not sufficient to sustain     post-hepatectomy liver function, techniques as preoperative portal vein embolization or     two-stage hepatectomy/associating liver partition and portal vein ligation (ALPPS) can be     performed. ALPPS induces rapid and extensive hypertrophy by portal vein ligation and in situ     liver splitting. To date, feasibility of the second stage of ALPPS has been assessed only on     the basis of standardized future liver remnant or future liver remnant on body weight.     However, decrease of liver function between stages, measured by means of laboratory     parameters, has been demonstrated to be associated with higher 90-day mortality, regardless     of FLR volume. In other words, this volumetric increase may not reflect the increase of liver     function.   "
33594|NCT02846064|"     Ovarian cryopreservation is one of the available option for preserving fertility prior to     potentially sterilizing treatments. In the absence of other techniques such as in vitro     folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used     by autograft. In France, the first live birth after orthotopic ovarian transplantation, was     obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency     of the graft in terms of restoration of ovarian function and live births. It will also allow     us to carry out the patient follow-up after ovarian tissue cryopreservation and after     autograft when achieved. In cases of neoplastic malignancies, minimal residual disease     detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.   "
33566|NCT02846428|"     This study will evaluate the efficacy and safety of treatment with oral capecitabine or     intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide,     prior to surgery in participants with breast cancer. The participants will receive 4 cycles     of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin +     Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85).     After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast     surgery with regional lymph node dissection will be performed, followed within a maximum of 6     weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study     arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by     IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period,     participants will enter the post-treatment follow-up period which will last for 5 years from     the initial date of participant randomization. During this period participants will be     evaluated once a year on the anniversary date of randomization.   "
33656|NCT02845258|"     Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case     of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In     modern medicine the preferred way to perform such a drainage is by the means of endoscopic     ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed     in different scenarios. The cyst appearance and the drainage stents and/or technique may     impact the clinical outcome.      This study is a prospective, single-center observational study on the outcome after     EUS-guided drainage of pancreatic pseudocysts.   "
33567|NCT02846415|"     This study intends to use Play Intervention for Dementia (PID) to promote cognitive functions     of people with early to moderate dementia.      This is a cluster randomized controlled trial aims to recruit 38 participants from two study     sites. Participants will be randomly allocated into intervention or wait-list controlled     groups. Both groups will receive the same content of PID programme at different time. The PID     consists of 12 weekly sessions. Each session lasts for 45-75 minutes. The PID will be     facilitated by a play specialist, trained elderly volunteers, and centre staffs. Cognitive     functions will be evaluated with Montreal Cognitive Assessment, Fuld Object Memory Evaluation     and Modified Verbal Fluency Test, conducted by a trained research assistant blinded to group     allocation. Centre staffs (not involved in the PID) will be interviewed. Every alternate     session will be video-taped for understanding the experience of the participants in the PID     programme.   "
33568|NCT02846402|"     HSPOT is a cluster-randomized trial designed to determine whether HIV self-tests are     acceptable and improve HIV testing rates and HIV status knowledge among female sex workers in     Kampala, Uganda. This study will determine whether directly giving participants an HIV     self-test or giving them a coupon to collect a test at a drug store or clinic improves     outcomes compared to standard of care.   "
33569|NCT02846389|"     Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The     investigators think that moderate exercise, done 15 minutes at a time, can reduce the     fatigue. This study is designed to gather more information, so that in the future, doctors     can recommend whether patients should engage in exercise during a radiation treatment course.   "
33570|NCT02846376|"     The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or     the combination of nivolumab with ipilimumab given after bone marrow transplant for patients     with acute myelogenous leukemia and myelodysplastic syndrome.   "
33571|NCT02846363|"     Acute stroke management represents a true medical emergency that requires prompt diagnosis     and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region,     France (AVC69) the investigators observed that only a small percentage of patients could     access to thrombolysis in time. In this cohort of 1306 patients treated in one of the     emergency department of the Rhone region for a suspected stroke, 84% of patients reached     hospital through an emergency department instead of going directly to a stroke unit. Among     those patients, only 8% were finally thrombolysed, because of extended management times.. Our     hypothesis was that public awareness campaign designed to improve public's knowledge and     skills would consequently reduce prehospital time and favour call to prehospital emergency     medical services (EMS).      The investigators will conduct an awareness campaign aimed at the general population, using     different communication media, the content will be developed based on the results of a     qualitative study with focus groups (Quali-AVC), and using a diffusion plan established with     communications professionals. To assess the effects of this campaign, a comparative     quasi-experimental before-after study will be conducted. A control region where no awareness     stroke program has been set up has been selected, data will be collected in the two regions.     The assessment of the impact of the campaign will focus on the comparison of the evolution of     indicators between these two regions. Three assessment time will be provided: before starting     the program, at 3 months and at the end of the program.   "
33572|NCT02846350|"     This study proposes to assess the impact of a provider-based intervention to enhance     re-engagement and improve retention, adherence, persistence and viral load among challenging     patients in Argentina   "
33573|NCT02846337|"     Type 2 cardio renal syndrome is defined by the occurrence or the exacerbation of a kidney     failure induced by a chronic heart failure. Sodium overload is one of the main causes leading     to the occurrence or the exacerbation of this syndrome. Some patients have a massive sodium     retention on which medications are not effective enough. These patients have no further     therapeutic options because of the refractory congestion and a 3-months mortality rate around     15%, frequent rehospitalization (3-months rehospitalization rate at 71%) and an excessively     impaired quality of life.      For those refractory heart failure with cardio renal syndrome, nephrology departments resort     to non-medication sodium extraction (hemodialysis, peritoneal dialysis, isolated     ultrafiltration). Between 2002 and 2008, 927 French patients would have start dialysis in     this situation. In 2013, 174 patients start dialysis in 97 dialysis centers. French National     Authority of Health recently published new Good Practice Guidance thereupon, strengthened by     the increasing number of publications and the widespread use of this technique. There is     therefore a consensus among professionals about the benefits of such a technique in those     indications. However, bibliographical data are not strong enough to support a strong level of     evidence. None of foresight strategies have been compared to others in a proper randomized     controlled trial, and there is no clue about any suspected superiority from one strategy to     another.      So far, the investigators propound invasive, expensive and not validated techniques to     patients with functional and vital prognosis altered. The investigators think it's essential     to prove the efficacy of such an approach. They wish to quantify those techniques impact on     rehospitalization, with a consideration for the potential survival impact.      It seems unethical to evaluate separated techniques, taking in account that patients with     severe heart failure will switch from one technique to another among their care. It is     therefore crucial to validate benefits from an invasive procedure (hemodialysis, peritoneal     dialysis, isolated ultrafiltration) compared to a medication-restricted care.   "
33576|NCT02846298|"     Since the discovery of streptomycin in 1944, aminoglycosides retain a remarkable bactericidal     activity vis-à-vis including aerobic gram-negative bacilli. Thus, their synergistic effect     with beta-lactams and their rapid bactericidal on many make unavoidable pathogens and make it     a cornerstone of the treatment of patients with severe sepsis or state of septic shock.      This is antibiotics exclusively parenteral administration. Their effectiveness is     concentration-dependent and are administered by 30-minute infusion. Tolerance of venous is     usually excellent. Their potential nephrotoxicity or cochleovestibular toxicity requires     accurate monitoring of antibiotic residuals.      Moreover the fact that the effectiveness of the aminoglycosides is concentration dependent,     the rate at the peak is decisive. A first sub-therapeutic dose leads to adaptively resistant     bacteria compared to the aminoglycoside and therefore an increase of Minimal Inhibitory     Concentrations (MIC). Many studies have been conducted in patients hospitalized in intensive     care, highlighting underdoses in aminoglycosides when the prescribed dosages consistent with     those used in non reanimated patients. Dr Moore showed in 89 ICU patients with bacteremia     gram-negative bacilli, the relationship between the clinical course and obtaining whether     therapeutic levels during the first administration of aminoglycosides. Thus, mortality in     patients whose antibiotic concentrations to peak were subtherapeutic, amounted to 20.9%     against 2.4% when concentrations were within the therapeutic range. In the context or an     initial peak in the PK / PD ( Pharmacokinetic / Pharmacodynamic) objectives namely Cmax / MIC     ≥ 8-10 desirable, individualized therapeutic drug monitoring and identification of factors     that may cause a concentration of antibiotic at sub-therapeutic peak seems necessary , in     patients for the majority an increased volume of distribution.      In addition to the β-lactams and glycopeptides, due to the increased volume of distribution     in critically ill patients in sepsis, evaluation of serum 24 hours after starting treatment     to check that the PK / PD goals for these molecules is achieved.   "
33577|NCT02846285|"     The various causes of bleeding Proctological are well known to gastroenterologists in     clinical practice but their proportions have not, to our knowledge, been dedicated     epidemiological studies. Investigators wanted to evaluate this data as part of a specialized     consultation. Investigators have prospectively collected the causes of gastrointestinal     bleeding down the patients seen two of us in specialized proctology center. A clinical     examination including an inspection, palpation and feel, and a anoscopy (when possible) were     made during the consultation. Local levies referred (s) histological and / or infection were     also carried out if necessary. When she had not been made, a colonic exploration was offered     to all patients over 45 years and / or when indicated by the pathological context. When there     were several possible causes, the clinician holding one that seemed to be the main. Patients     consulting within four months postoperatively a proctology action were not included. The     study period extended from September 2013 to July 2014 inclusive. The collection of anonymous     data.   "
33578|NCT02846272|"     To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative     workup of children with intractable epilepsy referred for surgery.   "
33579|NCT02846259|"     The first purpose of this study is to find out the clinical benefit and risk of oral aspirin     for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in     patients in the real world.      The second purpose of this study is to get the prediction model of aneurysm's rupture in     patients who has unruptured intracranial aneurysm (small than 7mm) combined with cerebral     ischemia , and find out who is suitable for oral aspirin.   "
33580|NCT02846246|"     Current home care service are to a large extent task oriented with a limited focus on care     recipient's involvement. Furthermore, studies have shown that low care recipients'     involvement might decrease older people's quality of life. Person-centred care focusing on     involvement has improved the quality of life and the satisfaction with care for older people     in health care and nursing homes but there is a lack of knowledge about the effects and     meaning of a person-centred interventions in aged care at home. Present study describes the     evaluation of a person-centred and health-promoting intervention.   "
33581|NCT02846233|"     In traditional step-up approach, the patients with poorly-controlled type 2 diabetes are     instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as the     most advanced therapy. However, a significant number of these patients continue to have poor     diabetes control. The most common reason is the noncompliance with multiple injections and     the patient's reluctance to accept insulin-induced weight gain. More recently, the algorithm     in diabetes management has significantly changed to accommodate the newer generation of     medications. Addition of the diabetes medications, that can induce weight loss such as oral     Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and once-weekly glucagon-like peptide     (GLP)-1 receptor agonists (GLP1 RA) injection, to a basal insulin is now recommended before     the patient is advanced to MDI. This approach works very well in most patients since weight     loss gives the patients an extra motivation to take medication regularly. Similarly, the     patient does not require to take an insulin injection before each meal throughout the day in     this approach.      Unfortunately, there are still a large number of patients with poor glycemic control who are     still on MDI. Some of them were initiated on MDI before the availability of newer generations     of medications. Some were started simply because the physician was not aware of or not the     familiar with the new recommendations. Regardless of the reason, these patients are likely to     remain on MDI despite chronic poor glycemic control since the physicians are understandably     reluctant to step down the most advanced insulin therapy. In addition, there has been no data     on the benefits and safety of the stepping-down approach from the most advanced insulin     therapy to the more patient-friendly approach that is the combined use of oral SGLT2i and     once-weekly GLP1 RA injection.   "
33582|NCT02846220|"     Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of     cardiovascular disease and premature deaths in the world. Despite availability of effective     drugs to control blood pressure, uncontrolled blood pressure and low adherence to     antihypertensive drugs persist as major public health and clinical challenges. On average,     50% of adults adhere to chronic disease medications and lower levels of adherence are     associated with worse blood pressure control and adverse outcomes. Many barriers to adherence     are well known and have been targeted in interventions to improve medication adherence. As of     yet, no single intervention has emerged as superior or even particularly effective in     improving adherence. The investigators have recently identified unconscious, self-protective     'hidden motives' that contribute to nonadherence to chronic disease medications. There is a     critical need to expand on this insight to test the potential for targeting individuals'     'hidden motives' for low adherence using an innovative learning process called     Immunity-to-Change.      As a critical step in testing this intervention to target these 'hidden motives', the     investigators will undertake a pilot study to assess the feasibility and acceptability of the     Overcoming Immunity-to-Change intervention and determine effect sizes of the intervention on     adherence, blood pressure (BP) control, and quality of life (QOL). The investigators will     test the Immunity-to-Change intervention in a sample of nonadherent older adults with     hypertension (n=18). Another sample of nonadherent older adults with hypertension will be     monitored for comparison (n=18).   "
33583|NCT02846207|"     This clinical research is based on the fundamentals of using Chinese medicine, which will     improve Qi and promote blood circulation, to treat patients in the recuperating stages of     cerebral infarction with deficiency in Qi and blood stasis syndrome. By assimilating Chinese     medical theory, this research aims to study the biological basics of the stroke and the cause     for the deficiency in Qi and blood stasis syndrome; explore the therapeutic mechanism of the     treatment methods; as well as ascertaining the relationship between Qi, blood and blood     vessels.   "
33584|NCT02846194|"     The purpose of this study is to determine the effect that the Brief Guided Imagery (BGI)     technique has on fibromyalgia patients suffering from chronic pain in regards to their sense     of pain, wellbeing and quality of life.      This study will explore whether daily training of one to two minutes exercises in Brief     Guided Imagery can reduce chronic pain and improve the quality of life of patients by     studying specifically patients suffering from fibromyalgia.      Chronic pain is a common condition which affects person's physical and mental health. It     occurs in between 10% to 40% of the population, depending on the exact research and chosen     sample. In 2010 Manchikant et al. found an effect chronic pain has on human functioning and     quality of life.      A research from 2007 defined chronic pain as pain that lasts more than three months. Being     long lasting by its nature, chronic pain has an ongoing effect on deteriorating the quality     of life. In this regards, quality of life is scientifically determined by five modes: i.     Physical wellbeing. ii. Mental wellbeing. iii. Social wellbeing. iv. Emotional wellbeing, and     v. sense of development and self-realization.      Chronic pain damages daily ongoing functions and is also related to sleep disturbances,     stress and unemployment. A direct correlation was also found between chronic pain and     psycho-social .      One of the many results of chronic pain is the huge impact on the economy, such as absence     from work due to sick leaves. The overall cost of chronic pain was found to be one percent of     the total expense on health. The frequency and impact of chronic pain is such that some     professionals define it as an epidemic.      In many cases, chronic pain occurs with patients suffering from a wide spectrum of medical     disorders. In 2007 Tunks et al. demonstrated that chronic pain often accompanies an illness     that involves also a psychological aspect.      Both Baird et al. in 2004 and Menzies et al. in 2012 found a significant positive effect     daily guided imagery exercises have on chronic pain. The study proposes to research the     specific technique of Brief Guided Imagery on chronic pain, and will focus on patients     suffering from fibromyalgia.      Fibromyalgia is a syndrome where a patient suffers from both chronic pain and a fatigue. The     pain of fibromyalgia is characterized as abstract and non-localized, while the fatigue     appears in a varying range of intensity. These symptoms are often accompanied by exhaustion,     lack of energy, somatic disorders and psychologic symptoms such as depression.      The ongoing pain, fatigue and depression cause fibromyalgia patients to further suffer from     sleep disorders and diminishing ability to function. Menzies et al. studied in 2012 the     effect of guided imagery exercises on the stress level, pain, fatigue and depression. The     study also examined different physiologic blood markers (such as proteins, cytokines and C     reactive.      Menzies found a positive and significantly large improvement in the ability to control both     stress and pain levels, and treat the depression of the participants. However, no significant     changes were observed in the blood tests monitoring the levels of physiologic markers in the     blood.   "
33585|NCT02846181|"     The primary objectives of the study are:        -  To assess the mass balance recovery after a single PO dose of [14C]-SK-1405        -  To provide plasma, urine and faecal samples for metabolite profiling and structural          identification   "
33586|NCT02846168|"     The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major     adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo     percutaneous coronary intervention.   "
33587|NCT02846155|"     By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the     investigators hope to find out the optimal gastric preparation plan.   "
33588|NCT02846142|"     This trial will consist of three parts: the first two parts will enroll healthy female     volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment     groups.      The SAD treatment group is comprised of at least 3 cohorts where subjects will be randomized     to a single dose of either PTI-428 or placebo and will be followed for 7 days post dose. A     total of 24 subjects are anticipated to participate in this part of the study.      Following the conclusion of the respective SAD level dose groups and after sufficient review     of study data and approval by the SRC, a second set of healthy adult female subjects will     participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3     cohorts where subjects will be randomized to either PTI-428 or placebo and will be followed     for a total of 14 days. The SRC will convene after the completion of each cohort to evaluate     safety, PK and other relevant data. The SRC will determine whether to proceed to the next     planned dose level, to reduce the dose, or to stop the study. The next cohort may commence     only after written SRC approval. A total of 24 subjects are anticipated to participate in     this part of the study.      Following completion of the SAD and MAD, 40 female healthy volunteers will participate in two     treatment periods of the DDI study component: Treatment period A will consist of once daily     oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off).      Treatment period B will randomize subjects to PTI-428 or placebo in combination with once     daily OC for 28 days (21-day hormonal active and PTI-428 or placebo + 7 days off). Following     completion of the subjects' second treatment period, they will be followed for 7-days after     their last dose.   "
33589|NCT02846129|"     Incidence of anesthesia related complications in multiple gestation patients undergoing     cesarean delivery has not been reported in Thailand. The aim of this study is to identify     complications that occur which may derived from different anesthetic techniques used, such as     hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion     and fetal outcome.   "
33590|NCT02846116|"     The aim of this study is to evaluate using of new ceramic material Vita Suprinity and lithium     disilicate on patient satisfaction combined with shade matching.   "
33591|NCT02846103|"     Increasing evidence suggests that immune responses might be a determining factor in lung     cancer tumor progression.      The impressive clinical responses obtained with immune checkpoint inhibitors     (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune     response is required for their efficacy and highlight the critical role of antitumor T cell     immunity. Recent progress on the fields of tumor immunology underlines the critical role of     CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity.     Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.      In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the     investigators group have previously described novel promiscuous peptides (referred as     UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared     tumor antigen.      By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected     in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this     response were inversely correlate to the disease stage. Furthermore, UCP-specific responses     were significantly found in patients with low PD1+ and TIM3+ T cells.      Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer     before and after treatment (chemotherapy, immunotherapy).   "
33592|NCT02846090|"     Nowadays, a number of cases with increased intraocular pressure and glaucoma have been shown     a huge increase . This is because of the increase the geriatric population in the community     and advanced medical care. Surgical correction, as a treatment, solves this problem greatly     especially with the modern surgical techniques .      Peribulbar block reduced the admission discharge time and reduced the burden on both the     patients and the medical team. On the other hand, it carries the risk of increased     intraocular pressure (IOP). Which, subsequently, limit its usage in glaucoma surgery.      Dexmedetomidine, as an alpha 2 agonist, has a well-established role in decreasing intraocular     pressure (IOP). This effect has been shown at a histological level and clinical level   "
33596|NCT02846038|"     Honest, clear, and empathetic communication between pediatric oncologists (POs) and parents     of children with cancer (POCCs) is imperative to facilitating therapeutic alliance and     ensuring that medical management aligns with the families' goals of care. Communication is     particularly important during conversations about disease reevaluation, which often     necessitate parental decision-making in the context of emotional distress. POs employ a     spectrum of communication styles and strategies during challenging conversations, and there     is no consensus regarding linguistic or thematic metrics for high quality communication of     upsetting information. In order to better understand how POs communicate difficult     information to POCCs, the investigators propose a pilot study designed to accomplish the     following primary aim:      Primary Objective:        -  To identify recurrent verbal and nonverbal (e.g. the use of pauses/silence)          communication techniques employed by POs in the delivery of difficult prognostic          information to POCCs through content analysis of audio-recorded conversations between          POs and parents of children with high risk cancer at the time of disease reevaluation.      The study expects to enroll up to: 30 patient participants, 30 parents, 6 primary pediatric     oncologists, 30 non-primary oncologist care team members, 30 extended family members, and 30     friends of the family (total = 156).   "
33597|NCT02846025|"     ABSTRACT      Epigenetic mechanisms may be involved in the regulation of lipid metabolism and inflammatory     markers may therefore contribute to the cardiovascular risk profile, as well as environmental     factors have a significant impact on the epigenetic program of gene expression. Methyl groups     are usually added or removed as needed and can be influenced by diet soon, dietary factors     have been linked to the change of DNA methylation, resulting in changes in gene expression.     Research on the prevalence of gene methylation levels on the impact of nutrient intake, as     well as the inflammatory condition and the results of dietary interventions for the genes, it     is a sparse area in studies and, therefore, expanding of the knowledge. Thus, understanding     the effects of a diet rich in antioxidants and hazelnut oil, in inflammation and DNA     methylation profile is important because chronic diseases with cardiovascular disease can     begin with the consumption of modified lipids and can research this stage provide important     dietary allowances for the development of this disease prevention strategies even in     adulthood. This PhD project is linked to a larger project entitled II Diagnosis Cycle and     Intervention Food Situation, Nutrition and Noncommunicable Diseases Prevalent over the City     Population of João Pessoa / PB (II DISANDNT / PB) and have two methodological designs: the     first one is the composition of a representative sample of adults in the city of João Pessoa,     from II DISANDNT / JP, population-based study and cross-sectional. The second methodological     design was developed with a subsample of the above population, selected from criteria being     the type and interventional clinical trial. This model will have to evaluate the effect of a     diet rich in antioxidant and hazelnut oil, in inflammation and gene expression.   "
33598|NCT02846012|"     The purpose of this study is to collect development and outcome data on human embryos which     are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective     to demonstrate its performance efficacy in comparison to existing commercially available     single culture or continuous embryo culture media.   "
33599|NCT02845999|"     Gastrointestinal (GI) cancers account for the most common cancers. Despite recent advances in     GI cancer treatments, the 5-year overall survival rate for these patients remain     unacceptable, except for patients who are candidates for metastasis surgical resection.     Strategies leading to a decrease of metastatic number and size will contribute to improve the     probability to undergo a curative surgical procedure.      Haploidentical Natural Killer (NK) cells can persist and expand in vivo following adoptive     transfer and may have a role in the treatment of selected malignancies, since the failure to     recognize the appropriate KIR ligand on a mismatched tumor cell can trigger NK cell     elimination of that target cell. NK also express an activating Fc receptor that mediates     antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines     in response to antibody-coated targets. Cetuximab, an IgG1 chimeric monoclonal antibody     against colorectal cancers that expressed EGFR (epidermal growth factor receptor), improves     overall survival and progression-free survival and preserves quality-of-life measures in     patients with colorectal cancer in whom other treatments have failed.      In an attempt to improve the outcome in GI cancers, we will conduct a phase I/II clinical     trial assessing NK cell based immunotherapy. Patients with liver metastases related to a     EGFR+ GI cancer, previously treated by a standard chemotherapy that did not achieve a     complete response or a curative resection of residual metastases will be included in this     phase I/II trial supported by the French National Institute of Cancer (INCA, PHRC 2005). This     phase I/II study will involve 22 patients. The main objective of this study will be to     demonstrate the safety of NK hepatic intraarterial infusion in association with cetuximab.     Secondary objectives will include the assessment of the clinical efficacity of this strategy.   "
33600|NCT02845986|"     The purpose of this study is to explore the safety and feasibility of the Laparoscopic     Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third     gastric adenocarcinoma（cT2-4a, N-/+, M0）.   "
33601|NCT02845973|"     The aim of the study is to identify and verify one or more gut bacteria of which the     abundance in feces may help to early diagnosis colorectal cancer.   "
33602|NCT02845960|"     The purpose of this study is to evaluate the influence of rapid recovery on sleep quality     following total knee replacement surgery.   "
33604|NCT02845934|"     This Study evaluates the performance (sensitivity, specificity, positive and negative     predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of     mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology,     microscopy and fungal culture, in a test group of 52 patients including :        -  patients at high-risk according to the EORTC/MSG criteria (patients with prolonged          severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of          allogeneic HSCT, or inherited severe immunodeficiency),        -  patients with other predisposing factors of invasive mould disease ( diabetes, AIDS,          haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed          with probable or proven mucormycosis irrespective of underlying conditions.   "
33605|NCT02845921|"     Propofol is an intravenous anaesthetic agent used for both induction and maintenance of     anaesthesia. An important adverse effect is the significant fall in blood pressure. The     current clinical study will be done to determine the efficacy of leg elevation and wrapping     in reducing the incidence and severity of propofol induced hypotension in patients undergoing     general anaesthesia.   "
33606|NCT02845908|"     The aim of this study was to compare the efficacy and safety of POF, FOLFOX, and FOLFOX plus     paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.   "
33607|NCT02845895|"     The prevalence of malnutrition in hospital is very high (30 percent) with major consequences     in terms of morbidity and mortality, generating significant health care costs. The positive     impact of its support is demonstrated.      The HAS (High Sanitary Authority) recommends a screening of all adult hospitalized in the     first 48 hours, with no consensus regarding the organization of screening within care     services. Various strategies have been implemented. Although this screening is part of the     nursing role, old and recent studies show that it is not done systematically and nutritional     disorders are largely under-diagnosed and therefore untreated.      The investigators assume that an organization of screening for eating disorders, based on a     caregiver dedicated to this activity, improves the indicator IPAQSS (Indicateurs Pour     l'Amélioration de la Qualité et de la Sécurité des Soins witch is an indicator for the     improvement of the quality and security of care) Screening indicator of nutritional disorders     Level 3, compared to an organization classic involving the care teams in their entirety.     This indicator reflects the care system performance.      In this study, patients will have no intervention. Only the organization of the care staff     will be adapted but with no changes on the care of patients   "
33608|NCT02845882|"     The outcomes of children with lymphoblastic lymphoma (LBL) in China in the investigators'     previous study were not unexpected. In this study, through further modification treatment     protocols and strengthen domestic multicenter collaboration, the investigators try to improve     survival for children with LBL when compared to the previous study.   "
33609|NCT02845869|"     During basic training, 15% of military recruits develop knee pain, which hinders their chance     to complete training. Current therapeutic options have had variable levels of success. Light     therapy was shown to reduce pain in chronic inflammatory related knee pathology. The current     clinical study is designed to evaluate light therapy, as an adjunct to conservative     physiotherapy for treatment of acute overuse KP in combat soldiers.   "
33610|NCT02845856|"     The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK)     immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.   "
33611|NCT02845843|"     This is a placebo-controlled clinical trial to assess the feasibility, efficacy and safety of     a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with     MERS.   "
33612|NCT02845830|"     Maintaining of improving the quality of life amongst the elderly with early phase dementia     (EwD) is nowadays one of the key aims of health care services. When investigating the quality     of life trajectories, it is necessary to examine contributing factors. The aim of the project     is to ascertain the profile of quality of life trajectory amongst Czech EwD and to identify     the most important factors affecting it. The results will be compared to the results from the     elderly without dementia. A quantitative approach, longitudinal prospected design utilising a     battery of questionnaires in the Czech language will be used. At the same time, translation     and validation of the Czech version of QOL-AD and PDI will be carried out. The group of     respondents will include EwD and elderly without dementia living in home environment.     Knowledge of the quality of life trajectory and the factors involved will enable     interventions to maintain or improve the quality of life of the elderly with early-stage     dementia in home environment in future. Project Aims The aims are to ascertain the quality of     life trajectory profile amongst the elderly with early phase dementia, to identify the most     important factors involved and to compare the results to control group. Validation of the     Czech versions of QOL-AD and PDI questionnaires will be performed.   "
33613|NCT02845817|"     This study take place in the palliative care units of Burgundy-Franche-Comté regions and at     the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand     the meaning of explicit requests to hasten death (euthanasia and assisted suicide).      This involves conducting interviews with patients, carers to whom the request has been     expressed and a relative chosen by the patient. This study aims to describe the request over     time. This will be done through two series of interviews, one as soon as it is first     expressed, then one week later.   "
33614|NCT02845804|"     The objectives of this study are        1. To establish a prospective registry of the whole patients who received percutaneous          coronary intervention with Xience Xpedition™/Alpine™ stent        2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience          Xpedition™/Alpine™ stent        3. To compare the long-term efficacy and safety of coronary stenting between the Xience          Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had          established their own registry   "
33615|NCT02845791|"     To investigate whether the interactive family based lifestyle programme leads to behaviour     change at 6 months with the primary outcome being increased levels of moderate to vigorous     physical activity (MVPA).   "
33616|NCT02845778|"     Melatonin is an endogenous hormone. It is able to promote nighttime sleeping and could induce     sleep at daytime in adult and children with the nonpainful diagnostic procedure. However,     previous formulation had problems of unstability of product and low oral bioavailability.     Melatonin niosomes oral gels are formulated in order to overcome the problem of drug     absorption and stability. This study is a randomized, double-blind, three phase crossover     design in 15 male volunteers. Melatonin niosomes oral gel will be applied at doses 2.5, 5,     and 10 mg with 7 days washout for each period. The pharmacokinetics data, sleep induction     effect, and adverse event will be determined.   "
33617|NCT02845765|"     The purpose of this study is to evaluate the correlation between fundus oculi's     vascularization in patients with erectile dysfunction and not, and, in the same patients,     before and after using drugs for ED.   "
33618|NCT02845752|"     The purpose of this study is to determine whether exercise can be prolonged in COPD can by     the inhaled bronchodilator Stiolto Respimat. The study will identify whether any endurance     benefit is due to reduction in fatigue that originates within the skeletal muscles and/or     from effects on neural activation of the skeletal muscles.   "
33619|NCT02845739|"     The main goal of project is to study the distribution of HPV genotypes in the anogenital area     and peripheral humoral immune responses HPV (total and neutralizing Ab) before and after     renal transplantation. Furthermore, the investigators wish (i) establish whether there is a     correlation between HPV infection and HPV immune response before and after transplantation,     and (ii) determine whether there is a link between HPV infection and immunosuppression.   "
33620|NCT02845726|"     This study is performed to analyze various aspects of biofilms on ureteral stents.   "
33621|NCT02845713|"     The study will be an open label cohort study with 2 two-treatment groups 2). Both groups will     be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg +     Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will include     men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will     include men and women who are free of W. bancrofti infection based on negative blood tests     for both microfilariae (Mf) and circulating filarial antigen (N=30). Active follow-up for     adverse events (AE) will be for 72hrs and passive follow-up for 7 days following treatment.      Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals     with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital     and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis (LF)     infected individuals any AEs develop within the first 72 hours following treatment and     uncommonly up to 7 days post-treatment.      All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.      Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling     for drug analyses and safety tests. Participants will undergo clinical monitoring every 6     hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine + Albendazole     (IDA) treatment. Participants will also be monitored for hematologic, or biochemical     abnormalities during the period of observation.   "
33622|NCT02845700|"     The study will use a prospective design consisting of three phases. The phases are:        1. the development of the sensory retraining treatment (SRT),        2. the evaluation of the treatment's feasibility and acceptability, and        3. an assessment of its efficacy.      During the third phase, a pilot study will be conducted in which participants will be     randomly assigned to either SRT or a waitlist control group in order to assess efficacy.     Diagnostic information and eligibility criteria will be assessed using the Structured     Clinical Interview for DSM-IV (SCID) and the Clinician Administered PTSD Scale for DSM-5     (CAPS-5).   "
33623|NCT02845687|"     The purpose of this study is to conduct an observational assessment of natural outcomes     within the Duke Smoking Cessation Program (DSCP), Quit at Duke. This assessment will     include information regarding abstinence rates, changes in patient emotional state following     treatment, and costs of operations. Primarily, this study will assess the financial     sustainability and the cost-effectiveness of the program.   "
33624|NCT02845674|"     This is a safety extension enrolling subjects participating in Study OTX-101-2016-001   "
33625|NCT02845661|"     Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and     sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain     cooperative and can be easily aroused. This study was designed to explore the correlation of     Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of     dexmedetomidine intravenously.   "
33626|NCT02845648|"     To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with     anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic     enuresis and evaluate the potential implication of improved AA for treatment response     prediction.   "
33627|NCT02845635|"     The purpose of this study is to better characterize the fluctuations in multiple sclerosis     symptoms and their relationship to medications, to length/extent of disease, and to a variety     of physiologic measures.   "
33628|NCT02845622|"     This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on     vascular reactivity and metabolic profile. Participants, divided in six groups, will receive     one of these breakfast integrations for 14 days:      group 1) 30 g peeled hazelnuts;      group 2) 30 g unpeeled hazelnuts;      group 3) snack with 30 g peeled hazelnuts;      group 4) snack with 2.5 g cocoa powder;      group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;      group 6) empty snack, control group.   "
33629|NCT02845609|"     Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release     formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA). The SA-ER is     currently studied as a substrate replacement therapy for patients with GNE myopathy. The     investigators plan to study the SA-ER compound in a cohort of five patients with GNE-related     thrombocytopenia.   "
33630|NCT02845596|"     The purpose of this study is to determine the feasibility of comparing outcomes of patients     treated de novo with immunosuppressive therapy (IST) versus matched unrelated donor (MUD)     hematopoietic stem cell transplant (HSCT) for pediatric acquired severe aplastic anemia.   "
33631|NCT02845583|"     the study consists of an observational study aimed at quantifying the economic burden of the     nursing activities on the overall cost of hospitalizations funded through DRG tariffs for     Major complexity oncology patients.   "
33632|NCT02845570|"     Imaging using 68Ga-DOTANOC PET (positron emission tomography) has the potential to detect     granulomas in pulmonary tuberculosis, leading to previously unexplored indications for this     PET tracer, including identification of subclinical disease in latently infected individuals.     This study aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in     individuals with active pulmonary tuberculosis.   "
33633|NCT02845557|"     Early onset type 2 diabetes mellitus among adolescents/youth (YT2DM) is a rising phenomenon.     The pathophysiology has been studied primarily on non-Asian populations while literature on     incretin effect is scarce. The investigators evaluated insulin sensitivity, beta-cell     function, incretin hormones and their effect in YT2DM from a multiethnic Malaysian     population. The characterization of this population may enable us to better tailor their     antidiabetic care.   "
33665|NCT02845141|"     The overall objective is the histological and radiological assessment of bony consolidation     of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous     spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.      Clinical correlation with the histological and radiological results using the SF36     questionnaire.   "
33666|NCT02845128|"     Multicentric cohort study recruiting patients admitted to the intensive care unit (ICU) with     acute respiratory failure (ARF) and receiving treatment with high-flow nasal cannula (HFNC).      This is a second part of the initial study PF(AG)101/2011 where the investigators created the     ROX index to predict the need of failure with HFNC treatment in patients with ARF secondary     to pneumonia, and the investigators want to validate ROX index with this second prospective     cohort results.   "
33634|NCT02845544|"     The study of the behavior of the mechanisms of body balance with a workout based on the     Pilates method can facilitate the development of more accurate rehabilitation approaches.     However, there is still little scientific information on its effects on the locomotor system     and it's necessary to search for new methods to evaluate its strategies more specifically.     Thus, this study aims to determine whether an exercise program based on Pilates method has     influence on the static and dynamic postural balance of sedentary adults. This is a     randomized controlled trial, which will be developed with an initial sample of 20 subjects of     both sexes, aged between 18 and 30 years, divided into two groups: a control group and an     experimental group. Participants with physical activity time up to 150 minutes per week will     be included, assessed by the International Physical Activity Questionnaire (IPAQ), and those     who have no experience with the Pilates method. In the experimental group a workout program     will be done for 6 weeks with individual classes including exercises based on the Pilates     method, during 1-hour, twice a week. Assessments will be made prior and after the training     program with anamnesis, anthropometric measurements and also the Balance Error Scoring System     and the Star Excursion Balance Test Y to assess postural balance. During the tests and     training program exercises the muscle activity of paraspinals and transversus abdominis will     be analyzed using surface electromyography (sEMG), and body mass center displacement will be     measured with a triaxial accelerometer positioned on the fifth lumbar vertebra. The data will     be entered in a spreadsheet and statistically tested with SPSS software. The tests will     include the comparison of means, association, correlation and effect size, which will be     chosen according to the distribution of the data and will use the 5% significance level for     all tests.   "
33635|NCT02845531|"     The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator)     implantation on the top of optimal medical therapy in patients with variant angina     manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause     compared with optimal medical therapy alone.   "
33636|NCT02845518|"     Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in pulmonary     vascular resistance leading to right ventricular (RV) failure and eventually to death. The     therapeutic strategy has become complex and needs to perform recurring follow up evaluations     including a right heart catheterization (RHC).      Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right     ventricular (RV) volumes and important prognostic predictors such as cardiac index, stroke     volume (SV) and right ventricular ejection fraction (RVEF).      The main objective is to assess the hemodynamic diagnosis performances (sensibility and     specificity) at baseline and at follow up visits of cMRI to detect an unfavorable hemodynamic     status in comparison with the results of the RHC (current guidelines).      The primary endpoint is: sensitivity and specificity of cMRI for the diagnosis of an     unfavorable status defined by the current RHC criteria (with 95% confidence interval).      The secondary objectives are: to identify clinical and hemodynamic variables independently     contributing to prognosis, to quantify complications due to cMRI and to RHC and to compare     acceptability and tolerability of cMRI over RHC for the patient.      PAH patients will be recruited in 18 centers of the French network of severe pulmonary     hypertension in a prospective cohort study.      180 subjects will be enrolled in the study: that size will give the study 90% power to find     significant at the 5%-level.      If the primary endpoint were reached, since first, strategies and procedures planed in this     project are consistent with those currently used in routine and second, inclusion criteria     are not limited to a sub-population of PAH patients, positive results could allow to broadly     extending our findings. Therefore, it will be possible to decrease the number of RHC, an     invasive and cumbersome procedure without altering the prognosis. Moreover all clinical     procedures would be performed in outpatient clinics and thereby would reduce the cost to     assess the severity of the disease. Current recommendations for evaluation of severity and     follow-up being mainly derived from consensus of opinion of the experts, positive results     will also improve the level evidence of severity assessment of PAH patients.   "
33637|NCT02845505|"     The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial     territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of     CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the     IVUS information about myocardial territory and stenosis severity and predicts the extent of     CAMS-derived myocardial size.   "
33638|NCT02845492|"     This study compares Qigong movement-based meditation exercise with a healthy living     exercise-wellness course. There are two primary goals of this research:        1. Evaluate and compare physiological mechanisms underlying the two wellness-exercise          interventions with the specific goal of understanding the physiology of Qigong.           Using a simple noninvasive EEG setup, the study will test some of the same brain          mechanisms that have been found in mindfulness meditation.           The study will also investigate Qigong's effects on stress and heart signals and on          inflammation in the immune system. A key hypothesis is that Qigong will show          distinctive, stronger effects on brain and heart measures. A related hypothesis is that          Qigong will show stronger effects on blood markers of inflammation.        2. Compare effect sizes of the two interventions in decreasing fatigue in order to plan for          a larger clinical trial.   "
33639|NCT02845479|"     Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative     care intervention delivered by naturopathic doctors in conjunction with standard surgical and     oncologic care of people with thoracic cancer.   "
33640|NCT02845466|"     Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or     more months to heal. Growth factors have been used to try and improve this healing, however,     many such studies have failed, and that is thought to be due enzymes in the wound that     degrade the growth factors and prevent them from working. This is a proof of concept study     that will evaluate the treatment of chronic leg ulcers with topically applied growth factors     that are combined with a therapy to prevent their inactivation in the wound.   "
33641|NCT02845453|"     The purpose of this study is to determine whether quetiapine is effective in the treatment of     youth with co-occurring substance use disorders and bipolar disorder.   "
33642|NCT02845440|"     The overall aim of this study is to test the effect of academic detailing (i.e.     provider-level educational intervention focused on evidence-based smoking cessation treatment     for those with psychiatric illness), alone or in combination with practical support from a     community health worker, on the provision and utilization of standard of care smoking     cessation treatment to those with serious mental illness (SMI). Further, this study will     determine if these interventions improve smoking cessation rates for adults with SMI who     smoke.   "
33643|NCT02845427|"     Comparative randomised study to clarify which better to use or no use of closed suction drain     system after total hip arthroplasty regarding amount of blood loss, need for blood     transfusion, risk for superficial infection, ecchymosis, wound discharge, effect on early     post-operative rehabilitation. Patients will be followed up for one month postoperative     clinically (Harris Hip score system), laboratory (Hb level), and radiologically (A-P view     plain x-ray of the hip).   "
33644|NCT02845414|"     This is a single center, phase I dose escalation study designed to determine the maximum     tolerated dose (MTD) or recommended phase 2 dose (RP2D) of deimmunized CD133KDEL     (dCD133KDEL), a ligand-directed, deimmunized pseudomonas toxin against CD133, in patients     with advanced, previously treated, refractory solid tumors.   "
33676|NCT02844998|"     The purpose of this study is to investigate the relationship between physical activity and     PE, and determine whether moderate physical activity might delay ejaculation time or be an     alternative treatment for PE.   "
33645|NCT02845401|"     The investigators' research is aimed at developing more effective, finite approaches for     managing individual patients with chronic hepatitis B (CHB). This prospective clinical and     basic scientific study exclusively focuses on patients with the early antigen negative form     of disease, which in developed countries is treated indefinitely with antiviral drugs. The     investigators' study BeNEG-DO, directly offers patients who are already taking standard     oral Hepatitis B Virus (HBV) antiviral therapy for at least 192 weeks the option to stop or     continue treatment. Drawing on data from pilot studies, including the investigators' own     University of California, San Francisco and Sutter Institutional Review Board-approved study,     the investigators will examine a finite HBV treatment strategy on clinical outcome and     safety. In conjunction, the investigators will study immunologic mechanisms and gene     expression profiles that correlate with and predict the post-treatment clinical course. The     BeNEG-DO study could seriously question, and potentially change, the current treatment     paradigm for millions of patients with CHB and also lead to new disease-terminating antiviral     therapeutics.   "
33646|NCT02845388|"     Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate     alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.   "
33647|NCT02845375|"     In this study the investigators will assess (i) the effect of partial neuromuscular blockade     (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to     isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by     sugammadex, neostigmine or placebo in healthy volunteers.      Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced     by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from     TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy     volunteers.   "
33648|NCT02845362|"     Measurements of dysphagia severity are important when making management decisions and in the     objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a     validated self-report inventory using a visual analogue scale. This questionnaire permits a     quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia     in different pathology. Opposed to largely used videofluoroscopy swallowing study and     endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure and     enables a readily available assessment. Validated French version is not yet available. In the     first phase of the study the investigators will validated this translation in dysphagic     patients and control. Secondly, the investigators will validate the SSQ in Neuromuscular     patients.   "
33649|NCT02845349|"     Traumatic brain injury (TBI) is a major public health problem with an annual incidence of     about 1.7 million per year. TBI is associated with various long-term morbidities. Among them,     psychiatric disturbances are the major cause of chronic disability and poor quality of life.     Major depression is the common psychiatric sequela post TBI with rates ranging from 13% at 1     year to 60% at 8 years after TBI. Major depression after TBI (henceforth referred to as TBI     depression) is often associated with comorbid neuropsychiatric symptoms (NPS) such as     anxiety, aggression, substance abuse and cognitive deficits that often makes treatment     difficult. Despite increased rates of depression, there is no Food and Drug Administration     (FDA) approved drug/s for its treatment.      The investigators propose to address these limitations by use of a novel serotonergic agent,     vortioxetine, which has a multimodal mechanism of action through serotonin transporter (SERT)     inhibition, 5-hydroxytryptamine (5-HT)3, 7, and 1D receptor antagonism, 1B receptor partial     agonism, and 1A receptor agonism.      Overarching Goal: The overarching goal of the proposed pilot study is to determine the     effectiveness and safety of vortioxetine for the treatment of post-TBI depression and     co-morbid NPS.      Study Design: The study design will include a DBPCT of 30 TBI patients of all severities who     meet the DSM 5 criteria for major depression. A total of 150 will be consented to allow for     screen failures. Written informed consent will be obtained from these patients. Subjects will     be followed for a total of 12 weeks. Subjects will be randomized to either the vortioxetine     arm (N=15) or placebo arm (N=15). The treatment group will receive vortioxetine 10mg per day,     which will be increased to 20 mg or decreased to 5 mg, if deemed clinically necessary, at     week 4 or 8. Subjects will have a total of 4-5 visits: Baseline evaluation (1 or 2 visits)     and follow-up visits at weeks 4, 8 and 12. Well-validated psychiatric instruments will be     used to compare the effectiveness of vortioxetine versus placebo treatment at week 12     compared to baseline Relevance: This study has the potential to provide strong preliminary     evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI     depression and its psychiatric co-morbidities. If found to be effective, results from this     study can be used to design larger studies and also determine brain changes associated with     its use via neuroimaging.   "
33650|NCT02845336|"     Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks     orbital tissues, resulting in characteristic changes in eyelid position, globe position in     the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially     blinding disease, and current treatments largely consist of nonspecific reduction of     inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED     progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital     changes become fixed and can be modified only by surgery.      The investigators propose to treat a cohort of patients with active TED using a selective     COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group.     The investigators hypothesize that celecoxib will reduce the severity of disease and/or     prevent progression to proptosis, diplopia, and corneal exposure or compressive optic     neuropathy.   "
33651|NCT02845323|"     This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab     plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus Urelumab,     while the other half will receive Nivolumab alone.   "
33652|NCT02845310|"     The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke     volume variation plus a restricted fluid management approach to standard fluid management in     patients undergoing major abdominal operations.   "
33653|NCT02845297|"     This is a multicenter, nonrandomized, open-label phase 2 study (with a safety run-in phase)     of azacitidine (AZA) 75 mg/m2 given IV or SQ on days 1-7 every 28 days in combination with     pembrolizumab 200 mg given IV every 3 weeks (starting on day 8 of cycle 1). The dose/schedule     of AZA selected for this study is FDA approved for patients with MDS/AML.   "
33654|NCT02845284|"     This randomized clinical trial is an adolescent focused implementation science study directed     at improved social support and prevention of both HIV/STI's and subsequent unplanned     pregnancies. The study population is pregnant adolescents who are attending antenatal care in     Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive     health promotion interventions compared to routine health care will be studied. The study     participants will be individually randomized to one of three arms.   "
34476|NCT02834520|"     60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control     individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing     Quantitative real-time polymerase chain reaction and immunohistochemistry.   "
33657|NCT02845245|"     Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of     high-energy trauma such as motor vehicle collisions or fall from a height. They are complex     injuries often associated with significant fragment displacement and severe soft tissue     injury, a combination that has long challenged orthopedic surgeons. Traditionally, surgeons     use plain film (X-ray) and CT scans (2 or 3 dimensional) to determine fracture pattern and     displacement. Yet, in some cases, it is still difficult to identify the relationship among     bone fragments, which often makes articular restoration challenging. As a result, patients     with non-anatomic joint reconstructions have a higher rate of poor outcomes.      The primary objective of this study will be to compare patient outcomes in two groups, one     group who will receive enhanced pre-operative planning (3D printed plastic prototype +     standard of care [SOC] imaging with 3D CT scan + plain film radiographs) and a second group     who will receive pre-operative planning using SOC imaging alone (3D CT scan + plain film     radiographs only). Patient outcomes collected throughout the 12 month post-operative period     will include an assessment of radiographic fracture healing (union, non-union, malunion),     pain using a Numeric Pain Rating Scale, Olerud and Molander Score based on patient's     self-report, and development of complications (infection, wound healing, re-operation, and     re-hospitalizations). The secondary objective of this study will be to evaluate whether     utilizing an enhanced pre-operative plan with a 3D printed plastic prototype altered the     original pre-operative plan based on SOC imaging alone (3D CT scan + plain film radiographs     only).   "
33658|NCT02845232|"     Blood transfusion requirement represents one of the most significant cost driver associated     with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in     older patients, AML in older patients is more often associated with adverse features than in     younger adults. Physicians might therefore decide to offer palliative or supportive care     rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy,     such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best     Supportive care (BSC). Blood transfusion requirement represents one of the most significant     cost driver associated with AML.      The present study assesses the cost-effectiveness of intensive chemotherapy versus Best     Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine     arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or     older regarding blood product transfusions from a French payer perspective. Intensive     chemotherapy and BSC were the comparators in this analysis, since they continue to represent     the most commonly used treatment for elderly AML according to the defined status of patients     considered as 'fit' or 'unfit' for intensive chemotherapy.   "
33659|NCT02845219|"     This trial is conducted in Europe. The aim of the trial is to investigate the influence of     oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of     ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy     postmenopausal females.   "
33660|NCT02845206|"     Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to     a satisfactory outcome in over 75% of patients. The pain and function after TKR can be     dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from     the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated     failure. Patient specific cutting blocks may result in a more individualised implant     placement, improved pain and function following surgery, and a long-lasting implant.      This trial is designed to investigate if there is any benefit to bespoke instrumentation in     terms of pain and function to the patient, and an economic benefit to the NHS.   "
33661|NCT02845193|"     The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents'     satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve     and facilitate the surgical procedure after lip closure. This might decrease the need of     further interventions to improve esthetics and function of CLP patients. This trial will help     the patients and practitioners in taking the decision of inclusion of NAM in the CLP     treatment protocol as a mandatory step or skip a useless procedure with all of its burden.   "
33662|NCT02845180|"     The purpose of this study is to assess local tissue reaction and retention of an adipose     allograft extracellular matrix at 3 or 6 months post-injection into the subcutaneous     abdominal tissue of healthy volunteers scheduled to undergo elective panniculectomy.   "
33663|NCT02845167|"     Basic animal research has demonstrated that exercise training can protect the myocardium from     ischemia-reperfusion injury through several biological mechanisms . This effect of exercise     training may be beneficial in the perioperative period when cardiac complications may arise.     However, exercise induced cardioprotection is lost completely within 18 days of stopping the     training program. This finding from animal research will be used to test the hypothesis that     3 days of consecutive exercise with the last bout conducted within the last 24/48 hours prior     to surgery, will have a cardioprotective effect . Specifically, exercise has been shown to     protect cardiac myocytes against reperfusion induced oxidative stress and mitochondria     against reperfusion induced damage. This exercise mediated cardioprotection is observed in     short moderate duration ischemia (i.e. 5-20 min) and moderate to severe (i.e.20-60 min)     ischemic insults. The effects of exercise induced cardioprotection have only been     investigated at cell level and it has not been shown whether this will translate into a     reduction in postsurgical reperfusion injury and associated complications. To study this     potential cardioprotective effect the investigators will aim to recruit patients who have a     high risk of receiving reperfusion injury during surgery. Specifically, the investigators     will recruit abdominal aortic aneurysm patients where the risk of heart complications is     high. There is also currently no evidence in the published literature with regard to the     effect of preoperative supervised exercise.   "
33664|NCT02845154|"     Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known     complication in liver transplantation. Several trials investigated variables that my     contribute to the generation of these two complications for reducing their incidence and     magnitude. The investigators will investigate the effect of acute conditioning of the     recipients circulation to the vasoactive mediators in the graft as well as the congested     intestine through intermittent purging of graft contents into the patient's systemic     circulation in living donor liver transplantation.   "
45133|NCT02694887|"     The objective of the present project is to study the accuracy of capillary blood level     measured by handheld lactate analyzers when compared with the reference methods     e.g.venepuncture blood gas analyzer sample.   "
33667|NCT02845115|"     The aging of the population, and greater exposure to noise, are responsible for an increased     incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that     has become a real public health problem. The main means of rehabilitation of this disability     is represented by the apparatus of patients with conventional hearing aids. However, these     hearing aids have several drawbacks that limit their profits, often abandoning the prosthesis     by the patient.      Middle ear implants were developed to answer these problems. They are intended to amplify the     sound signal by transmitting directly to the middle ear to compensate for the hearing loss     and are indicated in case of failure or contraindication of conventional equipment. However,     these middle ear implants currently have limitations as performance failure. Recent data show     that the performance of the ossicles repair techniques are dependent on the coupling of the     ossicular prosthesis to the ossicles. Furthermore, advances in the understanding of the     biomechanics of the ossicles confirm the importance of the placement and linkage of surgical     restoration processes. This data can be applied to middle ear implants to improve     performance. Indeed, a preliminary experimental study on anatomical parts, using analysis of     the vibration of the middle ear structures by laser velocimetry, allowed the investigators to     define the transducer placement method and coupling method to ossicles.      Investigators wish to validate in vivo results in a pilot study on a small number of patients     by comparing two surgical techniques guided by velocimetric measures.   "
33668|NCT02845102|"     Depression is common among individuals with chronic illness such as chronic heart failure     (CHF) or chronic obstructive pulmonary disease (COPD) and is a strong predictor of poor     clinical outcomes and high rates of avoidable 30-day readmissions. While depression is a     treatable condition, few people with depression receive effective treatment. The proposed     study aims to develop a relational agent system to deliver depression treatment to patients     with chronic illness and comorbid depression. While depression is a treatable condition, less     than 36% of people with depression receive effective treatment. The proposed study aims to     design and develop a technology-driven relational agent system to deliver a 6 module, blended     approach of cognitive behavioral therapy and self-management education (RA-CBT) to support     patients with CHF or COPD and comorbid depression. The relational agent is a human animation     program that interacts with patients, integrates best practices from provider-patient     communication theory, emulating the face-to-face conversational behavior of an empathic     provider emphasizing nonverbal communicative behavior such as gaze, posture, gestures, etc.     The RA-CBT program will be accessed via tablet technology by participants. The study     investigators will conduct a pre-post feasibility study to understand the feasibility and     acceptability of using the RA-CBT system and its effectiveness in treating comorbid     depression. If successful, this new approach to depression treatment would immediately expand     access and scalability for post-discharge mental health support in the care transition.   "
33669|NCT02845089|"     A retrospective observational longitudinal medical chart review study of randomly sampled     patients diagnosed with advanced/metastatic NSCLC. The minimum observational period for each     patient will be 12 months.   "
33670|NCT02845076|"     Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These     strategies have yet not been compared to each other. Therefore, the investigators planned to     perform a prospective, randomized, pilot study involving hypercapnic acute respiratory     failure patients ready to be weaned off from NIV. The investigators are going to compare the     success rate of NIV weaning and the duration of NIV after randomization between 3 NIV weaning     methods: gradual decrease in duration of NIV or level of ventilator support, and abrupt     discontinuation of NIV.   "
33671|NCT02845063|"     The study aims to systematically investigate the interaction between training modality, ACE     genotype and disease in heart patients whom complete a cardiovascular rehabilitation program.     This is carried out with the goal to improve the benefit of cardiovascular rehabilitation for     the patient by maximising adjustments in muscle structure and function with the intervention.     A population of healthy individuals will be recruited who will carry out the same training     program, in order to compare the training effects respective to the general population.   "
33672|NCT02845050|"     Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin     followed by radical cystectomy in patients with muscle-invasive bladder cancer (JaNEO).   "
33673|NCT02845037|"     The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single     oral doses   "
33674|NCT02845024|"     Aim:      The purpose of this study is to investigate the effect of nonsurgical periodontal therapy     plus doxycycline on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who     have periodontitis.      Materials and methods:      A total of 24 type 2 DM patients with periodontitis will be selected for the study, and     randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type     II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than     110 have), and also with periodontal disease are chronic moderate (at least in three areas     Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical     examination and radiographic signs are being); Takes place. The initial HbA1c Patients should     be between 7-9 percent over the past three months has changed his medication also found the     necessary explanations on how to do that consent, Plaque index (PI) by Loe & Silness,     bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its     absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. Group     1: (12 patients) was treated with oral hygiene instruction, Scaling, and root planing, and     doxycycline for 15 days; and Group 2: (12 patients) has the same treatment but with     placebo, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated     hemoglobin (HbA1c) level, will be reevaluated.   "
34477|NCT02834507|"     The purpose of this study is to determine the effect of two different multiple-dose regimens     of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of     levodopa in Parkinson's Disease (PD) patients.   "
33675|NCT02845011|"     The investigators will conduct a randomized, controlled, single-blinded study of patients     undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of 12 academic teaching     hospitals in Iran from August 1, 2016 to February 31, 2017. The intervention and control     groups were labeled group 1 and 2 respectively. The assessment tool was scored by the     principle investigator and an ICU nurse. The data analyzer was blinded to group randomization     and was not present during CPR.   "
33677|NCT02844985|"     The study is intended to identify gene polymorphisms significantly associated with specific     behavioral- and preoccupation-typologies of sexual addiction, and to identify additional     potential genetic markers of sexual addiction. Research subjects with sexual addiction will     be identified from the out-patient and in-patient populations of the investigative sites.     Research subjects in the Control Group will be identified from the general population and     from the student body of selected colleges. Approximately 1100 subjects will be enrolled in     the study. Anticipating 10% drop-out, this is intended to generate a population of     approximately 500 men and women clinically diagnosed with sexual addiction, and approximately     500 healthy men and women who do not meet diagnostic criteria for sexual addiction nor have     psychopathology who will serve as the control population.   "
33678|NCT02844972|"     Decisions to limit and stop active therapeutics are common in the emergency unit. They are     framed by the Leonetti law of 22 April 2005 recommending the refusal of unreasonable     obstinacy and care of the patient's pain in later life. The pain assessment is an issue for     these patients whose in majority, are not communicating. Moreover, no specific tool and the     teams in charge, not knowing the patient make the recognition and treatment of pain symptoms     very complex. This is the potential interest of directly involving the family or the person     of confidence in this management , the first step being the detection and evaluation of pain.   "
33679|NCT02844959|"     The aim of this study is to evaluate inflammatory response as a prognostic factor of atrial     fibrillation recurrency after ablation. Inflammatory response will be assessed by double     measurement of C-reactive protein, fibroblast growth factor 2 (FGF2), matrix metallopeptidase     8 (MMP8) and body temperature. Dynamics of change of troponin I will be measured     additionally.      After ablation each patient will be monitored with ECG telemonitoring system for 7 days.   "
33680|NCT02844946|"     Traumatic brain injury (TBI) is the signature wound of Veterans returning from the recent     operations in Iraq and Afghanistan (i.e OIF/OEF/OND), with up to 20 percent experiencing     persistent post-concussive symptoms. Among Veterans with mild TBI, the majority also     experience significant distress, including depression and post-traumatic stress disorder, as     well as persistent pain. Importantly, significant stigma is associated with seeking mental     health care among Veterans; and poor management of multiple conditions results in increased     morbidity and mortality, increased risk for suicide, and significantly decreased quality of     life. Thus the challenge for treatment providers is to provide a unified and acceptable     intervention for Veterans with these interdependent systemic comorbid concerns. The aim of     this proposal is to develop, refine, and evaluate a 1-day trans-diagnostic (i.e., applies to     more than one diagnosis) life skills workshop to help Veterans develop skills needed to     pursue valued goals in the face of life's challenges.   "
33682|NCT02844920|"     This study is designed to observe the presence or absence of intrauterine adhesions at 6     weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party     readers.   "
33683|NCT02844907|"     The purpose of this study is to determine the interaction of GLP-1 and GIP to regulate     insulin secretion in nondiabetic subjects. The first part of this aim will determine the     threshold plasma concentration of GLP-1 that increases insulin secretion to test the     hypothesis that fasting levels of circulating GLP-1 are insufficient to mediate β-cell     secretion. The second part of the aim will determine whether the insulin response to specific     amino acids is dependent on the α-cell release of GLP-1.      The study will enroll up to 40 healthy overweight participants and while it is anticipated     that the screening blood draw will yield a number of screen failures, it is estimated that 12     subjects will complete the entire study protocol. Enrolled participants will be asked to     complete five study visits including the consent visit and four infusion study visits that     will include hyperglycemic clamps. Each infusion procedure will last 4 hours.      The primary outcome for visits 2-3 will be insulin secretion in response to hyperglycemia and     GLP-1. Data will be analyzed using 2-way ANOVA for repeated measures using time and treatment     as the two factors. Post-hoc comparisons will be used to determine the stage when intact     GLP-1 levels exceed fasting levels and the stage when insulin secretion exceeds that of the     clamp alone. The primary outcome for visits 4-5 will be arginine-stimulated insulin secretion     with and without GLP-1r blockade. The mean increment of ISR above baseline in the 15 minutes     after arginine stimulation will be used to integrate insulin secretion, the primary outcome     measure, and two-way analysis of variance with fasting/hyperglycemia, and Ex-9/saline as the     two factors; post-hoc comparisons among the 4 insulin responses will be made if a significant     interaction is present.   "
33684|NCT02844894|"     This study investigates the effects of dexmedetomidine and esmolol given intravenously before     intubation on sympathetic response caused by intubation itself. Half the patients will     recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified     albumine levels will be measured   "
33685|NCT02844881|"     The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with     advanced solid tumors.   "
33700|NCT02844686|"     New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary     results suggested that dynamic acquisitions could allow the assessment of myocardial flow     reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the     feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac     SPECT in 20 patients.   "
33686|NCT02844868|"     Transcortical direct current stimulation (tDCS) is an emerging technique in the     rehabilitation of hemiplegic patients after stroke.      This study aims to assess the observance and the tolerance of repeated tDCS stimulation over     the primary motor cortex of the lower limb coupled to a motor training program, among     hemiplegic patients at the sub-acute stage. This is a prospective, randomized, double-blind,     study with two parallel groups of 15 subjects each. The study will analyze first, the     patient's observance considered good if 75% of the patients completed the entire protocol     duration and the tolerance through a questionnaire. The secondary end point will try to     estimate, if possible, the effect size of the walking performance measured with the     six-minute walk test and aerobic performance measured with VO2peak of this training program     compared to the same program combine with placebo stimulations. These evaluations are     performed before, during and after the rehabilitation program.   "
33687|NCT02844855|"     Memory for action is especially important in everyday life although current literature is not     very abundant. The enactment effect (i.e. better memory for performed actions than for     verbally encoded sentences) is usually described as a robust effect in aging and can be found     in many diseases. Although the enactment effect has been studied for three decades, there is     still no consensus on how it enhances memory. Therefore, in order to gain additional insight     into the representational basis of the enactment effect, in the present study, the     investigators propose to test neurological patients. The investigators suggested that memory     for action should be better than memory for verbally encoded information in Alzheimer's     disease and Parkinson's disease.      If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive     assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD     (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will     perform the same tests to verify that they have no cognitive impairment. Then, two     experimental conditions will be presented in all patients and controls: a first in which     participants will have to name drawings (verbal learning) and a second in which they will     have to reproduce an action associated with drawings (action learning). Immediately after     this learning phase, a recognition task will be available and therefore participants will     have to recognize drawings that had been presented previously. The main criteria used in the     statistical analysis will be the correct recognition score.   "
33688|NCT02844842|"     This is an observational prospective study to assess the tolerability and safety of treatment     of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be     administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at     initiation period till maintenance dose is reached) The study population is both: adult and     child, polysensitized to at least 2 allergen sources with rhinitis or allergic     rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.      The assignment of a patient to a particular therapeutic strategy will not be decided in     advanced by a trial protocol but will be determined by routine clinical practice. The     decision of the investigator to prescribe a particular treatment will be clearly dissociated     from the decision to include the patient in the study. The patients will not suffer any     intervention, whether diagnostic or monitoring, other than the usual in clinical practice.   "
33689|NCT02844829|"     This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum     level of PSA than 2.5 ng/ml or abnormal digital rectal examination.      Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla     (T) magnetic field using surface coils will be used to non-invasively predict the presence or     absence of prostate cancer.      Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine     twelve core TRUS biopsy.      Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh     biopsy sample will be collected and correlated with the presence or absence of prostate     cancer.   "
33690|NCT02844816|"     This phase II trial studies how well atezolizumab works in treating patients with non-muscle     invasive bladder cancer that has come back and has not responded to treatment with Bacillus     Calmette-Guerin (BCG). Monoclonal antibodies, such as atezolizumab, may block specific     proteins found on white blood cells which may strengthen the immune system and control tumor     growth.   "
33691|NCT02844803|"     The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis     Combination Therapy in Type 2 Diabetes Mellitus Patients.   "
33692|NCT02844790|"     This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic     (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in     healthy Chinese subjects.   "
33693|NCT02844777|"     This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled,     multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of     VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult     subjects.   "
33694|NCT02844764|"     This is a prospective open-label clinical study of 50 patients to determine safety and     treatment potential of autologous cell therapy for pain and inflammation associated with     Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000     patients.   "
33695|NCT02844751|"     This is a prospective open-label clinical study of 50 patients to determine safety and     treatment potential of autologous cell therapy for pain and inflammation associated with     Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000     patients.   "
33696|NCT02844738|"     This is a prospective open-label clinical study of 50 patients to determine safety and     treatment potential of autologous cell therapy for pain and inflammation associated with     Osteoarthritis of the shoulder. Follow-up will consist of a larger sample including 4,000     patients.   "
33697|NCT02844725|"     The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug     candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,     and placebo-controlled study.   "
33698|NCT02844712|"     Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by     mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a     negatively tested beta-lactam.   "
33699|NCT02844699|"     A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy     study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in     patients with prostate cancer.   "
33712|NCT02844530|"     The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan     for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370     MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for     the expression of CD22 has been chosen in order to propose this protocol to all adults with     CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is     almost 100% in this setting but some patients are documented between 70 and 100%. RIT will be     assessed in comparison with standard of care salvage chemotherapy regimens. Only three     standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for     the comparative analysis of clinical efficacy.   "
36877|NCT02802995|"     The aim of this study is to        -  To evaluate the safety and tolerability of Platelet Rich plasma(PRP)/Thrombin mixture in          treating chronic venous ulcers        -  To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers   "
33704|NCT02844634|"     Men who have sex with men remain at high risk for HIV infection. Targeting prevention     interventions to MSM at highest risk of seroconversion is an important goal of combination     prevention interventions. Antecedent diagnosis of another sexually transmitted infection     (STI), particularly syphilis, may serve as an entry point for biomedical prevention as these     individuals are at highest risk for incident HIV. The use of the antiretroviral combination     of tenofovir/emtricitabine has been shown to be associated with an overall 44% reduction in     HIV acquisition in high-risk MSM when taken daily as PrEP. In those individuals with     detectable drug levels, the benefit was as high as 90% risk reduction. In real-world     evaluations of PrEP, high-risk sexual behaviour may continue as evidenced by high rates of     intercurrent sexually transmitted infections. As such, biomedical interventions that may     offer additional reduction in acquisition of common sexually transmitted infections should     also be evaluated.      Recently a small pilot study has demonstrated potential benefit from a similar strategy for     syphilis prevention. In this study 30 MSM were randomized to receive either 100mg doxycycline     once daily or contingency management strategies linked to remaining free of sexually     transmitted diseases at progressive study visits. Overall, those receiving doxycycline were     significantly less likely to be diagnosed with any STI during followup than those in the     comparator arm.      The investigators therefore propose to undertake a pilot study to evaluate the feasibility of     using both tenofovir/emtricitabine and doxycycline (immediate or deferred use) for     pre-exposure prophylaxis amongst HIV-negative MSM with recent history of syphilis infection     in Vancouver, Canada.   "
33705|NCT02844621|"     The purpose of this study is to evaluate the effects of a common over-the-counter medication,     omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.   "
33706|NCT02844608|"     Symptoms related to the disease and/or treatment are common in cancer patients and can affect     patient health-related quality of life (HRQol). Unfortunately these symptoms can be     underestimated and underreported by the physician. Measure of the HRQoL has been     significantly developed in clinical trials and has become a key endpoint to assess clinical     benefit of new therapeutic strategies and as prognostic factor of overall survival for     several cancer as in women breast cancer, glioblastomas, metastatic colorectal cancer,     prostate cancer and hepatocellular carcinoma.      Moreover, a recent study conducted in patients receiving routine outpatient chemotherapy for     advanced solid tumors showed that clinical benefits were associated with symptom     self-reporting during cancer care, including the improvement of the overall survival.      The aim of the QOLIBRY project is to introduce the collection of HRQoL of cancer patients in     daily clinical practice in the University Hospital of Besançon. Indeed, the goal is to make     the HRQoL data accessible and exploitable in real time to physician, to help medical     professionals to optimize their practices by adopting a holistic and personalized approach     based on the perception of the patients of their HRQoL and symptoms.   "
33707|NCT02844595|"     The number of people who smoke, have concurrent depression and that seek treatment for     smoking cessation has increased in recent years. This implies the need to design intensive     and specific interventions that target this issue. In depression treatment, behavioural     activation is one of the psychological interventions whose characteristics of brevity,     flexibility and efficiency make it an ideal candidate to be included as part of smoking     cessation treatment, especially when smokers have depressive symptoms. The aims of the     present trial are: 1) to assess the efficacy (abstinence rates) of a psychological smoking     cessation treatment with elements from behavioural activation for managing depressed mood (a     randomized control trial with three groups: standard cognitive-behavioural smoking cessation     treatment, standard cognitive-behavioural smoking cessation treatment plus behavioural     activation, and a control group of delayed treatment) at the end of treatment, and at 3-, 6-,     and 12-months follow-ups; and 2) to assess whether the applied cognitive-behavioural smoking     cessation treatment plus behavioural activation improves depressed mood at the end of     treatment and 3-, 6, 12-months follow-ups.   "
33708|NCT02844582|"     This phase II trial studies how well cabazitaxel and prednisone work in treating patients     with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used     in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading.   "
33709|NCT02844569|"     This study will be a randomized clinical trial involving a total of 24 subjects. The     investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft     bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated     with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All     subjects recruited will have already been approved and treatment planned for extraction +     implant placement by non-study personnel to avoid any potential conflict of interest. All     subjects will have radiographs that show the tooth planned for extraction. Each subject will     be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth     extraction, subjects will receive a standard site preservation therapy consisted with     xenograft bone substitute + collagen dressing or the alternative site preservation therapy     consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month     healing period, subjects will receive a dental implant in the previous extracted site. During     the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be     obtained from the implant site. Biopsy samples will be stored for future histological and     histochemical analysis. After dental implant placement, all subjects will receive a healing     abutment for soft tissue healing prior to implant restoration.      During the 6-month healing time after tooth extraction and site preservation therapy,     subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning     for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography     (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate     extraction planning and at 6-month post-extraction for volumetric measurement and appropriate     implant treatment planning.      Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs.     6-month healing). CBCT images will be analyzed by non-contact reverse engineering system.     Soft tissue volumetric analysis will be performed to compare the soft tissue healing between     BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured     with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.   "
33710|NCT02844556|"     The purpose of this study is to carry out an international multicenter trial to get more     convincing and valuable results of the SMILE surgery and compare the outcomes between the     SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis)     surgery.      The investigators hope to investigate the differences between the SMILE and the FS-LASIK     surgery comprehensively, including the comparison of visual acuity, refraction, the     correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the     corneal ectasia, the characteristics of the changes of central corneal thickness and the     complications. To meet the demands of a multi center trial, all the examination equipments     should be same in each center, and this will limit the variations within a study   "
33711|NCT02844543|"     This study will assess the effects of exercise and non-concussive bodily contact on     eye-tracking scores collected by the EYE-SYNC eye-tracking device.   "
33715|NCT02844491|"     Cancer-specific splice variants gain significant interest as they generate neo-antigens, that     could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B     cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of     membrane expression of the spliced isoform.      The investigators group would now determine if it's possible, in patients with     lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20     peptides.      If this memory response exists, it will confirm the interest of this antigen as a target for     tumor immunotherapy.   "
33716|NCT02844478|"     The purpose of this study is to explore the differences in quality of life , inflammation,     stress, telomere length, and mucosal immune function of Hispanic and non-Hispanic caregivers     of persons with Alzheimer's disease and related dementias (ADRD). The caregivers will     complete the Stress-Busting Program for Family Caregivers in the language of their choice     (English or Spanish).   "
33717|NCT02844465|"     The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser     ablation system for mesial temporal epilepsy (MTLE).   "
33718|NCT02844452|"     Introduction: Atopic dermatitis (AD) is chronic relapsing inflammatory skin disease inducing     poor quality of life. Its conventional treatments often cause unsatisfactory relief and     adverse effect in long-term application. Acupuncture treatment is regarded to have curative     effect on AD symptoms. The aim of this trial is to evaluate the therapeutic effect of     acupuncture on AD symptoms including pruritus and poor quality of life in patients with AD.      Method and Analysis: This trial is randomized, sham-controlled pilot trial with different     visit frequency. 30 eligible patients with atopic dermatitis will be randomly allocated in a     ratio of 1:1:1 to the Verum Acupuncture group 1 (VA1, 3 days weekly), Verum Acupuncture group     2 (VA2, 2 days weekly) and Sham Acupuncture group (2 days weekly). The acupuncture treatment     will be given three or two times a week for 4 weeks according to the allocated group. The     main outcome measures are Visual analogue scale for itch (itch VAS), SCORing Atopic     Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) to evaluate the improvement of     AD symptoms and Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI)     to assess the quality of life of AD patients. It will be measured at baseline, once a week     during treatment period and after follow-up period.      Ethics/Dissemination: This protocol was approved by the Institutional Review Boards at Kyung     Hee University Korean Medicine Hospital on May 2016. The permission number is     KOMCIRB-160212-HRBR-004. This trial will provide the data of therapeutic effects of treating     atopic dermatitis with acupuncture in accordance with the different visit frequency. The     outcomes will be facilitated to calculate the sample size of further study with the same     design of this study. The findings from this trial will be published and presented in     conference.   "
33719|NCT02844439|"     This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with     recurrent glioblastoma.   "
33720|NCT02844426|"     To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria,     Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.   "
33721|NCT02844413|"     Regular exercise is recommended as an adjuvant treatment in hypertensive subjects by both     European and American guidelines. Crucially, however, there are no precise recommendations on     the type of physical exercise and how it should be instituted A relatively short period (5     months) of regular aerobic interval training (AIT), significantly decreased blood pressure,     pulse wave velocity, and most applanation tonometry indexes in hypertensive subjects also     undertaking pharmacological treatment in our study.   "
33722|NCT02844400|"     The primary objective of this study is to establish the feasibility and value of physical     fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this     project will establish the groundwork for physical function assessment in larger cancer     clinical trials to assist patient selection and evaluation of toxicity and/or response among     trial participants.   "
33723|NCT02844387|"     This study evaluates the nutritional supplement arginine as supportive measure for patients     with unresectable metastatic brain tumors that receive radiation therapy with palliative     intent   "
33724|NCT02844374|"     Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of     the world's population.      Although effective, epilepsy surgery fails in many cases, the percentage of patients free     from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of     epilepsy.      It is in this context that EPISTIM is interesting, and its aims isb a better     electrophysiology delimiting of cortical networks that imply the genesis of seizures with the     aim to improove surgery results.      This study will rely on the intracerebral records and on corticales electrical stimulation as     they are currently routinely used by epileptic patients candidates for surgery.   "
33725|NCT02844361|"     The purpose of this study is to evaluate whether autologous stem cell transplantation will     improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with     conventional chemotherapy.   "
33785|NCT02843568|"     The purpose of this study is to develop radiation plans that will help preserve lung function     in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in     designing radiation treatment plans that help us avoid healthy normal functioning lung tissue     close to lung tumors. Currently 4DCT scans are used to help us determine exactly where the     tumor is and how it moves when you breathe. In this study we will also use the 4DCT scans to     try to identify high functioning normal lung tissue.   "
33726|NCT02844348|"     A chronic renal disease can results in the development of cardiovascular complications,     including chronic arterial disease ; but a cardiovascular disease may be from a kidney     malfunction that will end in end stage renal disease (ESRD). Two thirds of the chronic     hemodialysis patients taken in charge in Grenoble in the last years suffered from an arterial     disease at a symptomatic stage. Breakthrough pain can appear during the hemodialysis     sessions. These sessions induce sudden hemodynamic changes and a peripheral vasoconstriction     reaction that increases in particular all pain phenomena related to chronic low limbs     ischemia. Therefore, patients have to face pain, sometimes chronic but also breakthrough     pain, during the dialysis sessions, in all its dimensions.      The analgesic balance through the classical drug treatment is extremely complex, as they are     both at risk of overdose and of partial effectiveness. Strict medical treatment remains     unsatisfactory, as it takes into account only the expressions of symptoms during dialysis     sessions, when most of the time pain is already installed and analgesic treatment is not     completely effective.      The combination of classic pharmacological treatment with hypnosis, already used in other     indications (chronic pain, analgesia, depression and anxiety), may mitigate the painful     feeling on patients suffering from arterial disease during the dialysis sessions, with a     beneficial impact on their overall quality of life. There is also evidence to suggest that     hypnosis may be more effective treating neuropathic or vascular pain, those experienced by     our patients, than musculoskeletal pain, like back pain.      Hypnosis is a mind-body approach focused on the subject, and not on the disease or the act of     dialysis. It can be described at the same time as a modified state of consciousness and a     particular intersubjective relation between a practitioner and his patient. The practice of     this kind of hypnoanalgesia by the nurses is particularly relevant in hemodialysis, as the     trust developed during regular chronic treatment can become an asset to shorten the induction     phase and help to install this intersubjective relation.      The high incidence of this complication, the difficulties of current pain management and the     impact on everyday life for the patients, justify the choice of this approach, where more     further research is needed.   "
33727|NCT02844335|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     advanced breast cancer.   "
33730|NCT02844296|"     Smoking is highly addictive and quitting is difficult. Relapse is common because of     withdrawal symptoms such as craving, headache, mood change and irritation. In addition to     pharmacotherapy, exercise can acutely reduce craving, withdrawal symptoms and negative affect     in regular smokers. Exercise effectively reduces negative affect and attentional bias towards     smoking, and hence might relieve craving.Instead of long duration (30+ minutes) exercise,     short-bout exercise is more easily adhered to in daily living and achieves similar health     gain as long-bout exercise.Handgrip, which enhances training of hand-griping strength, is a     common short-bout exercise tool used for lowering blood and arterial pressure.Therefore, this     exercise tool might also raise smokers' interest to initiate this simple and effective     exercise for quit attempt.      This RCT study was proposed by using short-bout exercise (intervention) and healthy diet     (control ) for smoking cessation, targeting adult clients who enrolled in smoking cessation     service of ICSC, smoke 10 cigarettes or more a day when they initially receive the treatment     from ICSC, can access to Internet by using smart phone and interested in participating in an     exercise/diet program for smoking cessation. All the participants will be randomized the     subjects to one of the RCT groups by using sequentially numbered, opaque sealed envelope     method. Participants from both groups will be helped to install a phone application (App) in     their smartphone which can send reminders of doing exercise or healthy diet. Also, the     participants will enter their smoking and craving data by the App by answering the automatic     pooped daily questionnaire. Telephone follow-up will be conducted at 2,6 and 12 months.   "
33731|NCT02844283|"     This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial     infarction disease.   "
33732|NCT02844270|"     The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a     total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin     Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo     coronary lesion.   "
33733|NCT02844257|"     Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an     uncontrolled proliferation of immature hematopoietic cells. Over the last two decades,     clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive     induction plus more potent intensification programs with chemotherapy alone or chemotherapy     plus stem cell transplantation (SCT) has improved treatment results. Advances in     understanding disease biology, improvements in induction and consolidation program, and     better supportive care have also all contributed. A number of clinical and laboratory     characteristics influence the response to treatment and, thus, the survival of patients with     AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable.     However, other factors may have a prognostic value and may influence patient's outcome.      Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it     has become apparent that the frequency of allogeneic blood transfusions can modify host     immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic     factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood     cell (RBC) transfusion need was identified as a strong and independent risk factor for     survival in MDS, for which the presence and severity of anaemia were attributed to a clonally     advanced and biologically more aggressive disease.      Based on these data, the investigators retrospectively assessed the prognostic value of RBC     and platelet transfusions at the time of diagnosis and the frequency of transfusions during     the first induction course of chemotherapy in a large unselected group of patients with     previously untreated AML.   "
33734|NCT02844244|"     To strengthen family well-being and neighborhood cohesion in Kwun Tong community, a community     -based Learning families campaign was conducted. As an initial step of this project, the     investigators conducted a need assessments before designing and conducting a     train-the-trainer workshop.The train-the-trainer workshop aimed to prepare the members of     Estate Management Advisory Committees (EMAC) and Mutual Aid Committees (MACs) to implement     and assist in conducting a series of community-based family well-being activities for     residents in a public housing estate. Focus group interviews (before and one year after     training workshop) were conducted to obtain opinion from the members of EMAC and MACs of the     public housing estate. Questionnaire assessments were conducted before, immediately after     finishing the training workshop, one year after training workshop.   "
33786|NCT02843555|"     The purpose of this study is to:        1. define novel homogeneous groups of patients with LDs and        2. work toward finding the cause of these disorders.   "
33735|NCT02844231|"     Sleepwalking (also called somnambulism) is a disorder in which only SWS is disrupted. This     NREM parasomnia is characterized by inappropriate motor behaviors, usually initiated during     arousal from SWS, that induce psychological distress and alter quality of life, leading to     fatigue, excessive daytime sleepiness, and objectively impaired vigilance in the morning.      The pathophysiology of sleepwalking remains poorly understood. Sleepwalkers had difficulty     maintaining stable, consolidated sleep and experienced more arousals and microarousals,     specifically from SWS, leading to increased NREM instability, especially during the first     sleep cycles. The brain is partially awake, resulting in behavioral manifestations, and     partially in NREM sleep, resulting in no conscious awareness of actions.      A Single Photonic Emission Computed Tomography (SPECT) study of one sleepwalking episode     found increased activation in the posterior cingulate cortex and cerebellum, with     deactivation in the frontoparietal associative cortices. Data from intracerebral EEGs during     confusional arousals confirmed both local arousal of the motor and cingulate cortices and     increased delta activity in the frontoparietal associative cortices.      The investigators thus proposed a controlled study of SPECT imagery in 24 sleepwalkers (12     SPECT during a SW episode and 12 SPECT during slow wave sleep and 24 during wakefulness) and     12 controls (during slow wave sleep and wakefulness). SW episodes will be elicited by sleep     deprivation condition associated with forced arousal (auditory stimulus).      The comparative analyses of SPECT acquisitions between different states (wakefulness, slow     wave sleep and SW) and populations (sleepwalkers versus controls) will provide new insights     about the complex pathophysiology of SW episodes.   "
33743|NCT02844127|"     The purpose of this study is to determine how the position of the right ventricular (RV) coil     of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation     threshold; specifically, can defibrillator threshold be improved by implantation site     selection.   "
33736|NCT02844218|"     Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those     aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly     patients, owing to comorbidities, the greater possibility of other hematopoietic disorders,     and a biologically poor risk prognosis. Anthracycline- and cytarabine-based therapy,     administered for 3 and 7 days respectively (3 +7), remains the standard induction therapy for     this patient population. This approach improved survival compared with supportive care     (median, 5 vs. 3 months) for adults aged ≥ 65 years. However, the overall view has been that     the results of intensive chemotherapy in elderly patients remain poor. Although complete     remission (CR) rates of 40% to 80% can be achieved in highly selected populations, long-term     survival has been poor. Furthermore, most clinical trials have only enrolled patients with an     adequate performance status (PS).      Prognostic models have been developed from clinical trial data to predict the outcomes for     older patients. However; each model relies on chronologic age. Age is a surrogate measure for     both changes in tumor biology and patient characteristics. Understanding which patients are     likely to benefit from intensive therapies versus low-intensity therapies or supportive care     is critical. The definition of fit to undergo intensive induction therapy has not been     established, and the therapeutic choice is mainly determined by physician and patient     decision. In older patients, low-dose cytarabine (LD-AraC) has been demonstrated to be more     beneficial than best supportive care and hydroxyurea. The recent availability of new drugs     that could have an improved side effect profile and, in some cases, bioavailability might     offer future improvement for this patient population. In this setting, the investigators have     tended to consider, since 2007, patients aged ≥70 years as potential candidates for     alternative lower intensity therapy (LD-AraC, hypomethylating agents) even when they     presented in good physical condition.      The investigators goal was to determine whether age ≥ 70 years could represent a useful and     simple cut off for treatment decision-making in clinical practice and whether low-intensity     therapy could be an alternative therapeutic approach to intensive chemotherapy even for     patients aged ≥ 70 years who were theoretically fit (WHO /ECOG/ PS of ≤ 2).   "
33737|NCT02844205|"     Neonatal intensive care is necessary for the survival of preterm baby. Several studies show     the deleterious effect on the immature brain due to stimulations caused by the environment     and hospital care.      However, a specific and individualized support to the development during the first weeks of     this preterm patient has a positive effect on newborn development.      A new practical newborn behavioral observation scale has been developed by the investigators     care unit in order to adapt care and individualized support to the development for each     patient.      The goal of this study is to estimate the external reproductibility of this scale by     experimented nurse in order to implement an individualized care program.   "
33738|NCT02844192|"     Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of     treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution,     vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin     underdosing in ICU patients, among others.      To date, bedside estimation of vancomycin volume of distribution is challenging, and new     methods for optimizing drug administration are required.      The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters     that may help estimation of vancomycin pharmacokinetics parameter.      The aim of this study is to test whether addition of hemodynamic parameters would improve     pharmacokinetics modelling of vancomycin concentration in ICU patients.   "
33739|NCT02844179|"     This research study is intended to determine the initial safety and tolerability of single     oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is     believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name     Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's     chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized     (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ,     the drug to be studied in this research, is the active ingredient in TBZ. The present study     will confirm safety and tolerability of HTBZ and will investigate its expected effects on     brain sites that are the target of TBZ therapy.   "
33748|NCT02844062|"     Chimeric antigen receptor (CAR)-modified T cells can mediate long-term durable remissions in     recurrent or refractory CD19+ B cell malignancies, and are a promising therapy to treat     glioblastoma, which is the most dangerous and aggressive form of brain cancer. EGFRvIII     mutation (epidermal growth factor receptor variant III, EGFRvIII) is the results of tumor     specific gene rearrangement naturally happened in about 30% of glioblastoma patients and     produces a mutated protein with neo-antigen that is tumor specific and is not expressed in     normal human tissues. Therefore, EGFRvIII is an attractive target for CAR T cell therapy. We     have constructed a lentiviral vector that contains a chimeric antigen receptor that     recognizes the EGFRvIII tumor antigen. A truncated EGFR (tEGFR) which lacks of the ligand     binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CAR     vector and is used for in vivo tracking and ablation of CAR T cells in necessary. This pilot     study is to determine the safety and efficacy of autologous anti-EGFRvIII CAR T cells in     patients with recurrent glioblastoma.   "
33787|NCT02843542|"     A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr)     prior to surgery in parathyroid tumor patients.   "
34478|NCT02834494|"     Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for     predicting histological response to neoadjuvant chemotherapy in patients with locally     advanced breast cancer.   "
33740|NCT02844166|"     The presence of pressure injuries has been considered a quality indicator of health care     services and efforts has been made to develop guidelines to prevent this issue. Intensive     care unit admissions (ICU) are recognized as risk factors to develop pressure injuries due to     reduced mobility of critically ill patients and large number of devices and hard technologies     that jeopardize preventive measures, such as, decubitus changes. There are not current     definitive evidence about the superiority of any support surface to treat or prevent pressure     injuries. The objective of the present study is to analyze if the use of viscoelastic support     surface in vulnerable critically ill patients decreases the incidence of pressure injury     compared with pyramidal foam support surface.      Randomized clinical trial performed in an intensive care unit for adult patients in a     philanthropic hospital. Inclusion criteria are patients admitted to ICU with Braden scale ≤     14. Exclusion criteria are age under 18 years, less than 24 hours of ICU length of stay,     contraindication of performing complete institutional preventive measures for support     injuries, presence of support injuries at ICU admission or absence of informed consent.     Randomization will be made by computerized generated numbers and patients will be allocated     in two groups in a ratio of 1:1. All study patients will be cared for according to standard     institutional preventive measures. The interventional group will be placed in an ICU bed with     viscoelastic support surface and the control group in an ICU bed with pyramidal foam support     surface. The main outcome evaluated will be the occurrence of type II pressure injury.     Secondary outcomes are the time to the occurrence of pressure injury, length of ICU and     hospital stay and 28 days mortality rate. Significance level will be 5%.   "
33744|NCT02844114|"     This study evaluates the effect of the serum level of Superoxide Dismutase (SOD),     Malondialdehyde (MDA), pro-inflammatory factors, stress hormones and Glutathione peroxidase     (GSH-PX)in tumor patients with the treatment of Ganoderma lucidum spore based combination     chemotherapy. Half of participants will receive Ganoderma lucidum spore and chemotherapy in     combination, and the other half will receive a placebo and chemotherapy.      Study design: Phase 2. Experimental: Ganoderma lucidum spore & Chemotherapy; Placebo     Comparator: Placebo & Chemotherapy.      Outcome Measure:        1. The life quality of participants was assessed with use of the Functional Assessment of          Cancer Therapy-General (FACT-G) questionnaire at the initial diagnosis (baseline) and at          42 days after the treatment;        2. Investigators assessed Procedural mortality factor ligand 1(PD-L1)expression          prospectively on tumour cells and tumour-infiltrating immune cells with the VENTANA          PD-L1 immunohistochemistry assay;        3. National Cancer Institute Common Toxicity Criteria.      Statistical analysis: All experiment results were analyzed with Statistical Product and     Service Solutions (SPSS) software (version 16.0). Data are presented as mean±standard     deviation and analysed by one-way ANOVA. Semi-quantitative data were compared using the     Kruskal- Wallis nonparametric analysis. The results were considered statistically significant     at P<0.05.   "
33745|NCT02844101|"     Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded     and the non-blinded group. The blinded subjects will be informed that we were testing the     reliability of a new device for body posture assessment and these youngsters will did not     receive any information with regards to physical activity. Conversely, the non-blinded     subjects were informed that the device was an accelerometer that assessed physical activity     levels and patterns. Participants will be instructed to wear the accelerometer for 4     consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall     duration and the duration relative to the quality of the physical activity patterns     (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group     during the 4-day monitoring, then compared between the two groups using the Student's t test.   "
33746|NCT02844088|"     Meningococcus C vaccine was first used in France to prevent epidemics. It was a success in     Puy-de-Dôme, Landes, Pyrénées Atlantiques and Hautes Pyrénées. Following many European     countries, France introduced meningococcus C conjugate vaccine in 2009 but this     recommendation was not suffiicently applied (6,6% of the 20-25 years-old were vaccinated in     2015).      The situation in France is very different from UK and there is no data on the subject. The     vaccination campaign in 2002 in Puy-de-Dôme offers much more detachment, possible comparison     between vaccinated and unvaccinated people, among which meningococcus circulation could     maintain immunity. This is the reason why we have decided to assess in 2016 the vaccinal and     natural immunity among Puy-de-Dôme population.   "
33747|NCT02844075|"     In this study, participants with esophageal squamous cell carcinoma will receive preoperative     chemoradiotherapy with paclitaxel,carboplatin and pembrolizumab then undergo surgery. The     primary study hypothesis is that adding pembrolizumab will increase complete pathologic     response rate at surgery.   "
33760|NCT02843906|"     The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's     Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of     cognitive deficits in older patients with bipolar disorders.   "
33788|NCT02843529|"     The proposed study is designed to evaluate the performance of the ALTOIDA™ System as a tool     to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings.     The design of this study is guided by two overriding factors: 1) to optimize the performance     of the ALTOIDA™ neuromotor classifiers, the subjects making up the training sets must be well     characterized as to their clinical diagnosis, and 2) all ALTOIDA™ tests must be performed and     reproduced in real-world clinical settings.   "
33749|NCT02844049|"     Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more     than 40% of patients are resistant to the standard pharmacological and psychotherapy     approaches and about 10% show severe disability and require institutionalization. These     resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain     Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate     neural networks. Although promising, these results need nevertheless to be replicated and     confirmed within a larger cohort of patients and considering a different main objective,     instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive     functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond     symptom reduction, health-related quality of life (QoL) represents a more important objective     of a treatment, as it includes both the individual's functional status and the individual's     subjective perception of the impact of the illness on the patient's life. STN DBS induces     significant clinical improvement, which may not be proportional to the QoL gain.     Consequently, QoL appears to be a better outcome to target in the coming studies than     clinical improvement alone. THe investigators thus propose a prospective study assessing the     QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT)     at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus     BMT alone.   "
33750|NCT02844036|"     Currently, the standard treatment for proximal thromboses lesions responsible for     post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages     are judged too distal or the patient is judged inoperable for a curative surgical gesture,     there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent     embolism. Prognosis is then pejorative with a 60% mortality at 5 years.      This study propose an alternative treatment for these patients in therapeutic dead end.     This is about applying arterial thrombosis technique to the pulmonary circulation.   "
33772|NCT02843737|"     The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep     fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.   "
33773|NCT02843724|"     A two year, two arm pragmatic trial to investigate the integration of naturopathic care with     conventional medical care to provide additional benefit beyond that of conventional medical     care alone in achieving adequate control of diabetes.   "
35557|NCT02820363|"     The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used     in conjunction with standard-of-care treatment compared to standard-of-care treatment alone     in the care of subjects with open fractures of the tibial diaphysis.   "
33751|NCT02844023|"     Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is     the most frequent vasculitis of the population over the age of 50. This vasculitis is at the     origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes.     Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp     hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with     the possibility to go blind. Until now, the standard treatment is a high dosage     corticosteroid therapy.      Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990.     The relapse rate is important, ranging from 10 to 64 % according to studies. There are also     issues of becoming dependent on steroid.      So it is important to determine new diagnosis markers and a therapeutic following of giant     cells arteritis.      With this study several biomarkers of inflammation will be studied in order to determine if     one ore many of them have a good sensitivity and special feature for diagnosis and following     of giant cells arteritis.      The main goal is to determine a new diagnosis marker for giant cells arteritis.   "
33752|NCT02844010|"     This study is based on the change in weight of hospitalized patients knowing that the     diagnosis of malnutrition based on the presence of at least one clinical or laboratory test     which anthropometric measures (Evaluation of diagnostic protein energy malnutrition in     hospitalized adults ANAES , Guidelines Department, September 2003; HAS Strategy supported in     cases of wasting energy and protein in the elderly April 2007).      The goal of this study is to find the correlation between hospitalization and weight loss,     significant risk factors for malnutrition in a situation of community-acquired pneumonia     infection.   "
33753|NCT02843997|"     Bipolar disorder is a chronic and frequent mood pathology, that impacts on emotional and     socio-professional life of sick subjects, and also increase mortality by suicide. Suicide is     considered as a bipolar disorder result.      The main goal of this study is the endophenotype characterization from a clinical and     cognitive point of view, of a bipolar spectrum's disorder present in a family, and then     highlight a mutation of one of the genes involved is this disorder.   "
33754|NCT02843984|"     Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid     concentration of 47 cytokines, chemokines and growth factors.   "
33755|NCT02843971|"     Monocentric, prospective study, comparison of the water drinking test response in the supine     and in the sitting position using the intraocular pressure monitoring device Sensimed     Triggerfish in healthy subjects.   "
33756|NCT02843958|"     This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of     blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).      This device was created as an alternative to blood sample, that have to be done in a medical     laboratory.      The main goal is to evaluate the accuracy of the International Normalized Ratio (INR)     measurement of this new portable device for diagnostic in vitro, among healthy patients and     patients under anti-vitamin K treatment.   "
33757|NCT02843945|"     Initial study to evaluate local control and the preferred method of attachment of the     CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor     removal.   "
33758|NCT02843932|"     The aim of this study is to reveal neurobiological bases of the motor control of conscious     perception, thanks to new techniques of functional cerebral imaging (MRI), and potentials     deteriorations connected to neuropsychiatric disorders like conversion disorder.      The Hospital University Center of Grenoble will provide patients from Neurology department,     characterized with non psychogenic epileptic seizures and abnormal psychogenic movements,     from conversive origin.      Subjects will be scanned by Magnetic Resonance Imaging during a motor paradigm inducing a     perceptive conflict between two informations : proprioceptive information coming from the     action (drawing) and visual information (draw's mark) that appears on the screen when there     is movement.   "
33759|NCT02843919|"     The goal is to identify neuro-physiological signatures at several levels of mental workload     during the realisation of tasks, performed by all the subjects.      In parallel, there will be a methodological work consisting to develop the classification     algorithms, predictives of these levels of mental workload in real time, in purpose to     implement a passive brain-machine interface in the best interest of operators that accomplish     complex tasks.      Mesures of electro-physiological activity will be recorded in order to approve states of     charge in addition to behavioral performances.   "
33761|NCT02843893|"     Sedation-analgesia is an important therapy for patients in resuscitation. It requires a     surveillance, in order to avoid excessive or insufficient dosages of sedative or     nonmorphinics, sources of side effects. Yet, means of surveillance are limited in     resuscitation care : variations of blood pressure and heart rate are not very sensitive     criterias. Clinical scales to measure the sedation and analgesia level were proposed for     patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural     pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive     stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients     under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold     by pupillometry for patients in resuscitation receiving a sedation-analgesia.      The main goal of this study is to measure the minimum intensity of a painful stimulation     (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care     receiving sedation-analgesia continuously.   "
33762|NCT02843880|"     Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to     80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any     pathological consequence. Immunosuppression may reactivate the virus causing either a     CMV-active infection or a CMV disease with attributable symptoms.      In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical     immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is     to study the risk factors for developing viremia or CMV disease in ICU patients in septic     shock without previous immunodepression and determine the relationship between viral     reactivation and this acquired immunity alteration.   "
33798|NCT02843399|"     Primary objective of this study is to compare diabetes-related healthcare utilization and     costs in patients initiating exenatide once weekly vs insulin glargine.   "
35558|NCT02820350|"     The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to     renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute     kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)   "
33763|NCT02843867|"     The incidence of atherosclerotic complications is increased after kidney transplantation.     Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an     inflammatory disease in which all players in the immune response are involved. The impact of     these immune responses is not well known in immunocompromised patients, particularly among     organ transplant. Nevertheless, the work of our group suggest that innate and acquired     responses through different mechanisms influencing the evolution of atheromatous disease     after transplantation.      The investigators therefore propose to study the impact of the expansion of regulatory T     cells on the risk of atherosclerotic complications after transplantation.      Since November 2008, the investigators began a multicenter, prospective study whose purpose     is to study in detail the immunological mechanisms of atherosclerosis after transplantation     via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It     was planned to include 500 patients and to date a little more than half have been included.     After completion of the blood test, the tubes are routed over the Biomonitoring Platform     (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.      The atherosclerotic events are recorded prospectively. The investigators hope to implement as     part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells     on the risk of atherosclerotic events.      Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5%     of atherosclerotic complications.   "
33764|NCT02843841|"     The prevention of allograft rejection in kidney transplantation requires administering to the     patient an immunosuppressive regimen of induction. The induction strategy is based on an     injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a     lymphocyte lysis, or an injection of monoclonal antibodies directed against non-lymphopenic     the α chain of the IL-receptor 2 (anti-CD25 antibody, basiliximab), by immunological risk     patients. Our group showed a significant increase in death rates in transplant patients with     lymphopenia CD4 continued beyond 2 years of transplantation. This excess mortality is related     to complications following chronic inflammation observed in some patients lymphopenic.      Preliminary studies have shown that the induced lymphodéplétion ATG appears to be accompanied     by an increase of the bacterial products in the blood of transplanted since a significant     increase in the sCD14 is observed in these patients one year. We also observed increased     concentrations of LPS in patients in the ATG group. This could indicate a secondary bacterial     intestinal translocation to a weakening of intestinal immunity linked to the ATG.      The main objective of the study is to assess the impact of anti-lymphocyte globulin     polyclonal on intestinal permeability, estimated by the rate lipopolysaccharide (LPS, a     constituent of the cell wall of Gram-negative bacteria) blood after kidney transplantation.      The secondary objectives are to evaluate bacterial translocation, the effect of bacterial     translocation on structural and metabolic functions of the intestinal epithelium, chronic     inflammation, immune reconstitution, regeneration, activation and proliferation of T     lymphocytes, the polymorphism of the LPS receptor that causes the activation of innate     immunity and the composition of the intestinal microbiota.      The study population consists of renal transplant patients of Nephrology of the University     Hospital of Besancon. Patients will be divided into 2 groups according to induction     immunosuppressive therapy prescribed the day of renal transplantation as part of their usual     care, ie treatment with anti-lymphocyte globulin polyclonal (ATG-Fresenius®) or antibody     treatment monoclonal anti-CD25 (basiliximab Simulect). The patient group treated with     anti-CD25 antibody will serve as a control group (no depletion of the immune system) to the     group of patients treated with ATG.   "
33765|NCT02843828|"     The purpose of this study was to investigate the effects of the new wearable hip assist robot     developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea)     to gait rehabilitation in elderly adults and stroke patients.   "
33766|NCT02843815|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     advanced NSCLC.   "
33767|NCT02843802|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     advanced liver cancer.   "
33768|NCT02843789|"     The aim of this study is to analyze the variation of adiponectinemia and its molecular forms     in RA patients receiving tocilizumab therapy.   "
33769|NCT02843776|"     The study epiDESA2 identifies all explicit requests for euthanasia or assisted suicide     expressed by the person him/herself, regardless of which professional is asked and regardless     of where the request is made (primary care, health institutions, medico-social institutions     including nursing home care or at home) in the Burgundy-Franche-Comté region during six     months.   "
33780|NCT02843633|"     This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the     Gazelle™ Bare Metal Stent arm of the Leaders Free study in high bleeding risk patients.   "
33781|NCT02843620|"     This study evaluates the effects of 40 mg of b-2Cool, a food supplement rich in native     type-II collagen, on healthy adults with joint discomfort. Half of the participants will     receive the b-2Cool containing supplement while the other half will receive a placebo pill.   "
33782|NCT02843607|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     advanced kidney cancer.   "
33783|NCT02843594|"     The purpose of this research study is to evaluate the clinical outcomes of different cataract     surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.   "
33784|NCT02843581|"     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to     advanced esophageal cancer.   "
33770|NCT02843763|"     As early complications of transplantation (acute rejection and infections) were better     controlled and that the survival of kidney transplants has increased, chronic complications     of immunosuppression became increasing challenges. The incidence of cancer is greatly     increased in transplant and cancer is now the first cause of death. The iatrogenic     immunosuppression plays a major role in the increased incidence of cancer. If it is accepted     that the incidence of cancer is generally increased after transplantation, the increased risk     is very different from a specific cancer to another. Furthermore the specific treatment of     the tumor (surgery, radiotherapy, chemotherapy, biotherapy), the specificity of the context     of transplantation is related to the possibility of modulation of immunosuppression. However,     there is no immunological marker for predicting the effectiveness of a modification of the     immunosuppression.      Several studies point to the important role of CD4 T cells into Th1 anti-tumor     immunosurveillance group cancers. Identified helper degenerate peptides, called Universal     Cancer Peptide (UCP) derivative of telomerase, a type of tumor antigen universal. These UCP     peptides bind most HLA-DR alleles most frequent of the population and have the particularity     of specifically stimulate CD4 T cells of type Th1. Using a test based on the UCP, it possible     to detect the presence of spontaneous CD4 Th1 anti-UCP answers in several types of human     cancers.      The main objective of this study is to determine whether, in renal transplant patients, the     occurrence of cancer is associated with a deficiency of CD4 Th1 response anti-hTERT.   "
33771|NCT02843750|"     To obtain definitive evidence for the effectiveness of a short preoperative inspiratory     muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical     resection.   "
33774|NCT02843711|"     LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during     the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung     adenocarcinomas. For all patients, clinical data and histopathological data are available.     The objective of this study is to characterize these lung adenocarcinomas by the LungCarta     Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations     and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the     adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform     immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are     correlated with clinical, histopathological and molecular data.      Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's     expression.   "
33775|NCT02843698|"     The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics     in morbidly obese patients   "
33776|NCT02843685|"     Many health care interventions and medications found to have benefits (efficacy) in     experimental, tightly-controlled, human research trials are later found to lack real-world     health benefits (effectiveness). Inadequate surveillance of real-world clinical     effectiveness may falsely reassure clinicians and those who monitor healthcare quality,     propagating unrecognized ineffective or harmful treatments at high costs to patients and     society. The failure to translate potential health benefits into realized gains, or to detect     unexpected harms in healthcare delivery, stems from a lack of methods with which to robustly     measure real-world (in)effectiveness. Current methods to detect changes in outcomes 'before     and after' implementation may be biased by secular trends in healthcare practice and     outcomes; other methods to compare outcomes for treated and untreated patients may be biased     by unmeasured factors.      The current project aims to develop and demonstrate - as a proof-of-concept - the use of a     quasi-experimental research method called 'regression discontinuity design (RDD)' in     surveillance of real-world clinical effectiveness. RDD had previously found use in the     evaluation of educational programs in which students scoring below a threshold were assigned     an intervention. The US Department of Education considers RDD designs to have quality similar     to randomized trials.   "
33777|NCT02843672|"     INTRODUCTION      Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of     surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head,     shortening and / or raising the metatarsal. It has been somewhat controversial, with more     than 25 different lesser metatarsal osteotomies described to date.      The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment     in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a     valid technique that yields results similar to open osteotomy for the treatment of     metatarsalgia and other forefoot problems. It has been somewhat controversial the choice     between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO)     and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders     and retractors surgeons in open and percutaneous surgery.      The purpose of this study is to compare the clinical results between two different surgical     treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).      MATERIAL AND METHODS      The investigators design an open randomized controlled clinical trial with patients operated     in the same centre.      The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the     criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with     different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for     hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal     percutaneous osteotomy for lesser toes deformities.   "
33778|NCT02843659|"     The primary objective of this study is to evaluate the efficacy of treatment with either     lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's     syndrome as measured by the change from baseline in ESSDAI at Week 12 between active     treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.   "
33779|NCT02843646|"     The purpose of this study is to investigate the use of the WalkAide, a Neuroprosthetic     device, on a child's ability to ascend/descend stairs and curbs. It is hypothesized that with     WalkAide use, the improved ankle control achieved, will affect the speed, symmetry, and     independence of completing the task.   "
33789|NCT02843516|"     Implantable Loop Recorders (ILRs), are subcutaneous heart monitors, which are implanted for     different reasons including syncope (fainting), pre syncope (near fainting), palpitations and     stroke. They monitor the heart and detect abnormalities.      Atrial fibrillation (irregular heart rhythm),is a common cardiac arrhythmia associated with a     five-fold risk of stroke. Atrial Fibrillation increases the risk of stroke in patients to a     different degree according to a risk stratification score. Anticoagulation is recommended to     all high-risk patients.      Recent published studies have shown a high incidence of Atrial Fibrillation detected by ILRs     in patients with previous stroke.      It is not known whether a similar incidence of Atrial Fibrillation occurs in patients without     previous stroke. It is also not know ''how much'' Atrial Fibrillation is necessary to     increase the risk of stroke, how relevant the finding of Atrial Fibrillation is and whether     everybody with Atrial Fibrillation should have anticoagulation or whether a bit of Atrial     Fibrillation is actually normal in most people.      The purpose of this study is to identify and compare the rate and the burden of Atrial     Fibrillation (more or less than 30 seconds) in patients with and without previous stroke.      Medical notes and Implantable Loop Recorder records of the patients that had the devices     implanted in Addendbrooke's Hospital from March 2009 up to 1 month after the implantation of     the latest device will be inspected in order to identify whether the device had detected     Atrial Fibrillation and if so the burden of Atrial Fibrillation in the two different groups     of patients (with and without previous stroke).      The risk of stroke for each patient will be calculated. Echocardiographic (ultrasound scan of     the heart)risk factors for Atrial Fibrillation will be identified and compared between the     two groups.      This is going to be a retrospective study and we will be inspecting patients' data only.   "
33799|NCT02843386|"     After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external     radiotherapy) patients with high risk of metastasis are randomized between:        -  Adjuvant chemotherapy with Fotemustin.        -  Observation      Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance     of Fotemustin, quality of life, and Overall Survival.   "
33809|NCT02843256|"     Carbon-12 and carbon-13 are naturally-occurring isotopes that are found in exhaled breath.     Investigators have proved that the 13CO2/12CO2 breath delta value (BDV) changes in subjects     who were in negative energy balance then fed a positive energy balance meal. Measuring one     liter of exhaled breath daily may be a more convenient way to measure negative or positive     energy balance in patients receiving intravenous nutrition.   "
33850|NCT02842710|"     The main objective of this study and to know the incidence of healthy carriers of     Staphylococcus aureus resistant méti- patients supported for fracture of the proximal femur .      This assessment will be made preoperatively by a nasal sampling and analysis through it by     rapid Polymerase Chain Reaction method GeneXpert® .   "
33790|NCT02843503|"     Primary objective is to assess the impact of different reference glucose measurement methods     on the measured performance of a CGM system, aiming at further standardization for the     assessment of CGM systems. Secondary objective is to describe the relationship between     glucose concentration of venous, capillary and arterialized-venous measurement samples.      Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes aged     18 years and older will be included.      Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the     clinical research center (CRC) twice during a 6 day period. These visits will have a duration     of 8 hours. Blood will be drawn for the determination of glucose concentrations using venous,     arterialized-venous and capillary sampling techniques. The patient will receive his usual     breakfast and an increased insulin bolus will be administered to correct the breakfast     glucose excursion with the aim of inducing a period of minor hypoglycemia. Blood sampling     will continue until the end of the admission. The sensor will be worn until the end of the     second 8-hour CRC session, which will be planned on day 6 or earlier depending on patient     preference. The sensor will be removed and their sensor and blood glucose meter data     downloaded from the devices. In the case of sensor failure before the first CRC session,     patients will be instructed to insert a new sensor per the manufacturer's instruction and to     notify study staff of the event. In case of failure of the sensor after the first CRC session     but before the second CRC session, patients will return to the CRC for sensor removal and for     data download.   "
33791|NCT02843490|"     Several studies during the last years reported the involvement of anti-retinal autoantibodies     in ocular disorders, such as AMD. These studies support the growing evidence of an     immunological involvement in the pathogenesis of AMD. In the planned trial it is planned to     enroll 70 subjects, i.e. 50 subjects with neovascular AMD and 20 healthy volunteers. The     investigators will evaluate the change from Baseline (Visit 1) in BCVA score at Week 12     (visit 4) in the study eye of nAMD patients treated with Ranibizumab. Neovascular AMD     patients (group 1) will be accompanied for 6 months and blood samples will be collected at     baseline and monthly until Visit 7 for analysis of antibody profiles. Healthy volunteers     (group 2) will be enrolled and a blood sample will be collected once for analysis of antibody     profiles. Antibody profiles of all study participants will be analysed to address questions     as defined in the outcome measures.   "
33792|NCT02843477|"     It is still challenging to assess intravascular volume status in spontaneously breathing     patients. Recently, the measurement of corrected flow time in carotid artery was introduced     as quite useful, simple and noninvasive for the evaluation of circulating blood volume     change. The aim of this study is to evaluate whether corrected carotid artery flow time as     determined by ultrasonography can be a predictor of fluid responsiveness in spontaneously     breathing patients before induction of general anesthesia.   "
33793|NCT02843464|"     Patients with acute myocardial infarction (AMI) are in critical condition especially without     emergency reperfusion therapy. For example, heart failure, heart rupture, malignant     arrhythmia are in high level. It was reported remote ischemic preconditioning (RIPC) may play     an effective endogenous cardiac protection. This study will investigate whether long-term     RIPC can improve the short-term and long-term (1 year) prognosis of AMI patients without     emergency reperfusion therapy. 220 AMI patients without emergency reperfusion therapy were     randomly divided into 2 groups: long-term RIPC group (once RIPC/day for a year) or control     group (routine treatment). Cardiac troponin (TNI), high-sensitivity C-reactive protein     (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1     (HIF-1), echocardiography and magnetic resonance（MR）were detected in hospital, 1 month and 1     year after discharge. Patients will be followed up by telephone at the end of one year. The     major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous     myocardial infarction, unplanned revascularization and stroke.   "
33794|NCT02843451|"     The proposed study will consist of a 9 week double-blind cross-over study trial of milk     thistle in 15 people (ages 18-65). The study will be divided into an initial 4 week phase, a     one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting     of active treatment with milk thistle, and the other 4 week phase consisting of inactive     placebo treatment. Participants will be randomized to receive either milk thistle or placebo     during the first 4 week phase on a 1:1 basis. This blinding will be maintained by the IDS     pharmacy at the University of Chicago.   "
33795|NCT02843438|"     Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop     learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an     amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults     immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical     diagnosis of ocular toxoplasmosis is more complicated in presence of posterior     neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs     heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this     situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.      Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host     and the pathogen and there can trigger a crossed immune response. Stress proteins haven't     been explored yet, in the context of toxoplasmosis uveitis on humans.      The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers     of ocular toxoplasmosis.      The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG     anti-Hsp70) in toxoplasmosis uveitis.   "
33797|NCT02843412|"     Background: Gastric cancer (GC) is major global health concern and the second leading cause     of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the     Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu     antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity     of Her2/neu overexpression and amplification in GC should be noticed. The investigators     investigated the significance of evaluating Her2/neu expression in different paraffin blocks     of tumor tissue in GC.      Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one     tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin     blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry     (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks     and used the higher one as the final score.   "
33800|NCT02843373|"     The overarching goal of this research program is to elucidate causal and directional neural     network- level abnormalities in depression, and how they are modulated by an     individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the     investigators can overcome a major limitation of EEG - the inability to demonstrate     causality. Here, we plan to recruit patients with medication-resistant depression undergoing     rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the     excitability and connectivity profiles of brain networks and how they are modulated during     treatment. This study aims to provide objective brain network measures that can predict and     track clinical response to TMS treatment. Findings from this study will be utilized to     develop a novel, personalized treatment protocol based on individual brain networks.   "
33801|NCT02843360|"     The major elements of the survey were sampling, questionnaire design, field survey and     database construction. This survey incorporated the multistage stratified sampling scheme.     Questionnaires include health status, utilization of health care, health behaviors, quality     of life, and social economic status.   "
33802|NCT02843347|"     The STRIDE Biorepository is an optional substudy available to participants in Bone Marrow     Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN     1503) (STRIDE).   "
33803|NCT02843334|"     Fabry Disease (FD) is a rare genetic lysosomal storage disease including an X-linked mutation     and characterized by an alpha-galactosidase A (GLA) deficiency. It causes     globotriaosylceramide (GB3) accumulation within blood vessels, tissues and organs. This     accumulation leads to multisystemic deficiency, such as progressive kidney insufficiency. Due     to its low prevalence and non-specific symptoms, FD is under-diagnosed. Its estimated     incidence is ranged from 1/40,000 to 1/120,000 live births. A review of the international     literature suggests a higher prevalence among dialysis patients. Its diagnosis could lead to     an enzyme replacement therapy, in order to avoid the occurrence or aggravation of other     organs irreversible lesions, and to enhance the familial screening.      We aim to conduct a multicentric cross-sectional prevalence study in 5 areas     (Rhône-Alpes-Auvergne, Ile de France, Aquitaine, Picardie and department of Gard), involving     biologic collection and genetic diagnosis test. Our objective is to measure the prevalence of     FD among dialysis patients. Eligible patients will be included after signing the informed     consent.      In the five participating areas, all of the dialysis centers will be asked for involvement.     Nominative data of the French renal epidemiology and information network (REIN) registry will     enable first patients screening for eligibility among prevalent dialysis patients. If needed     (insufficient or absent data in the REIN registry), data will be completed with medical     files.      A blood drop will be collected during a hemodialysis session (or the monthly test for     peritoneal dialysis treated patients) and deposited on an anonymized blotting paper. For the     diagnosis of FD, men will have a measure of the alpha-galactosidase activity, whereas     screening in women will be established on the association of alpha-galactosidase activity and     lyso-GB3 analysis. If results are compatible with FD, genetic mutation will be search in     order to confirm the diagnosis for women, and, for all, to offer familial testing. Results     will be transmitted to the nephrologist within the next 2 to 9 weeks. Patients diagnosed with     FD will be managed in accordance with the guidelines of the French National Authority for     Health (F.N.A.H.).   "
33804|NCT02843321|"     To assess the safety and biological efficacy of prophylactically administered donor-derived     multi-infection specific cytotoxic T lymphocytes (CTLs) (targeting cytomegalovirus (CMV),     Adenovirus (Adv), Epstein Barr virus (EBV), Varicella-Zoster virus (VZV), Influenza (Flu), BK     virus (BKV), and Aspergillus (Asp)) combined with early immunisation with Influenza and VZV     vaccines for the prevention of viral and fungal infection following allogeneic blood or     marrow stem cell transplantation.   "
33805|NCT02843308|"     The proposed study aims to investigate the efficacy of adding in-home decluttering practice     to Buried in Treasures Workshop (BIT) facilitated group treatment for hoarding disorder.   "
33806|NCT02843295|"     Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is     characterized by a progressive decline in graft function correlating with tissue destruction.     Recent data suggest that it may be possible to delay graft destruction if adequate management     is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design     new tests allowing physicians to predict transplant recipients prone to develop CAN   "
33807|NCT02843282|"     The purpose of this study is to examine cognitive and brain changes in individuals with     bipolar disorder as a result of a cognitive training intervention.   "
33821|NCT02843100|"     The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled pilot     trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine     whether induction of remission and maintenance of remission can be achieved with a new     dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen     and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be     compared to the gold standard dietary regime involving 8 weeks of EEN.   "
33822|NCT02843087|"     The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered     offspring from obese and normal weight mothers.   "
33823|NCT02843074|"     This is a phase 2, single arm, open-label, multicenter study to evaluate the feasibility and     tolerance of the combination of elotuzumab, lenalidomide, and dexamethasone in the induction,     consolidation, and maintenance treatment of transplant eligible, newly diagnosed multiple     myeloma patients.   "
33824|NCT02843061|"     The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to     recurrent B lymphoma.   "
33808|NCT02843269|"     Several RCT studies have aimed to reduce either musculoskeletal disorders, sickness     presenteeism, sickness absenteeism or a combination of these among females with high physical     work demands. These studies have provided evidence that workplace health promotion (WHP)     interventions are effective, but long-term effects are still uncertain. These studies either     lack to succeed in maintaining intervention effects or lack to document if effects are     maintained past a one-year period. FRIDOM (FRamed Intervention to Decrease Occupational     Muscle pain) is a WHP program among health care workers. A job group characterized by having     high physical work demands, musculoskeletal disorders, high sickness presenteeism - and     absenteeism.      FRIDOM aimed to reduce neck and shoulder pain and secondary to reduce sickness presenteeism     and sickness absenteeism. An other secondary aim was to decrease lifestyle-diseases such as     other musculoskeletal disorders as well as metabolic-, and cardiovascular disorders - and to     maintain participation to regular physical exercise training, after a one year intervention     period. The entire concept was tailored to a population of female health care workers. This     was done through a multi-component intervention including 1) intelligent physical exercise     training (IPET), dietary advice and weight loss (DAW) and cognitive behavioural training     (CBT).   "
45934|NCT02684396|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels     in healthy participants.   "
33810|NCT02843243|"     A risk stratification in hemodynamically stable patients with acute pulmonary embolism (PE)     is deemed necessary to guide patient management. With the aim to improve the positive     predictive value (PPV) for PE-related adverse events in in normotensive patients, a number of     scores combining multiple risk-factors have been published. In addition, an algorithm for the     risk-stratification of patients with PE has been proposed by the European society of     cardiology. None but one of these scores underwent external and prospective validation. The     aim of this study is to externally and prospectively validate the PPV for PE-related adverse     events of the Bova score and modified FAST score in a large multicenter cohort.   "
33812|NCT02843217|"     Aim: Determine the overall effectiveness of a targeted digital messaging intervention at     improving colorectal cancer (CRC) screening rates compared to care as usual.      Hypothesis: Screening rates will be higher for patients who receive the digital messaging     intervention, compared to the control group in which patients receive care as usual.   "
33813|NCT02843204|"     The aim of this study is the safety and efficacy of anti-PD-L1 plus NK immunotherapy to     multiple solid tumors.   "
33814|NCT02843191|"     This trial is to assess the efficacy and feasibility of consolidation chemotherapy after     neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.   "
33815|NCT02843178|"     Improving diets through increased food and vegetable (F&V) consumption significantly reduces     the risk of cardiovascular disease (CVD). Programs increasing the accessibility and     affordability of F&Vs among low-income Americans have been hindered by the food consumption     cycle associated with poverty: the tendency to over-consume calories shortly after receiving     funds at the beginning of each month, draining the budget for F&V purchases, or for all food     purchases, by month's end. An emerging theory about dietary behavior suggests that providing     funds for food in smaller installments distributed throughout the month will smooth the     consumption cycle and improve healthy eating—counteracting the tendency to respond to lump     sum, once-monthly funding installments by purchasing calorie-dense foods immediately after     funds are received. The theory also suggests that funds targeted toward specific healthy     foods (e.g., F&Vs) will improve diets more than untargeted funds, despite the inconvenience     of utilizing targeted funds. We will rigorously test both hypotheses in a real-world setting     by comparing alternative approaches for delivering food purchasing vouchers. We have     established and tested the infrastructure to provide vouchers accepted by numerous food     sellers (e.g., supermarkets, corner shops) in low-income neighborhoods. Leveraging this     infrastructure, we will conduct a randomized trial with a two-by-two factorial design,     comparing $20 of vouchers valid for one month to four $5 vouchers each valid for a sequential     week of the month (lump sum versus distributed funding), and comparing vouchers restricted to     F&V purchases to vouchers redeemable for any food (targeted versus untargeted funding).     Low-income adults (N=288) recruited through our community partners will be randomized to one     of four 6-month interventions: monthly targeted, monthly untargeted, weekly targeted, or     weekly untargeted vouchers. Participants will be assessed through efficient verbal 24-hour     dietary recalls validated among low-literacy populations, to determine daily consumption of     F&Vs and metrics of overall dietary quality at months 0, 6 and 12 (6 months after vouchers     end). Additional surveys will identify moderators and mediators of dietary improvement.   "
33816|NCT02843165|"     The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT)     combined with checkpoint blockaded immunotherapy (CBI) will improve the response to the     anticancer treatment compared to CBI alone in patients with advanced metastatic cancer.   "
33817|NCT02843152|"     This study use Loewenstein cognitive function rating scale to meet the standards of the     elderly cognitive function assessment. POCD diagnostic criteria used is the recommended value     Z current international law, in order to reduce the effects of exercise, we selected 50 cases     of patients with age-matched healthy control group as a spouse, the same scale testing. And     Loewenstein Assessment Scale cognitive function after some domestic research proved to have     good sensitivity, and easy to test small changes in cognitive ability.      Before the investigation began strict inclusion and exclusion criteria, the use of simple     intelligence scale exclude preoperative cognitive decline in the elderly significantly, the     use of depression rating scale for anxiety rating scale before surgery to exclude severe     depression and severe anxiety in elderly self self patient. Testing by the same person in the     same way neurocognitive assessment test twice, 7 days apart.      Studies in Chinese population, susceptibility SNPs and genetic POCD but there are few reports     of this project uses 1: 1 matched case-control study, by comparison POCD SNPs and control     groups of different polymorphisms, polymorphisms Discussion Han population of postoperative     cognitive dysfunction associated with susceptibility to find Chinese Han population of     postoperative cognitive disorders genetic susceptibility markers, which provide scientific     screening and early diagnosis of postoperative cognitive impairment at high risk in     accordance with   "
33818|NCT02843139|"     Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood.     Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested     as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese     children at risk for diabetes in future.   "
33825|NCT02843048|"     Despite being effective in weight reduction in severely obese patients, bariatric surgery     (BS) negatively influences bone metabolism and increases the risk of falls thereby     potentially increasing the risk of fracture. The mechanisms of BS induced bone loss are     unknown but may be related to calcium and vitamin D malabsorption, changes in the energy     regulation metabolism and gastrointestinal hormonal physiology. Since the etiology of BS     induced bone loss is largely unknown, treatment relies mostly on calcium and vitamin D     supplementation, which provide little benefit.      Exercise is an effective strategy to prevent bone mass losses in several health conditions.     However, no study so far has examined the effects of an exercise-training program in the     prevention of BS induced bone loss. The investigators main goal is to investigate the effects     on bone metabolism and fracture risk of an exercise-training program specifically tailored to     improve bone health and balance of patients that underwent BS. The investigators will perform     a randomized controlled trial on obese patients (n=80; BMI>40 Kg.m-2) elected to BS. Patients     will be randomly assigned into 2 groups i) a group receiving standard follow-up and medical     care, or ii) a group that will undergo a 11 months' Exercise Training program designed to     improve bone health and reduce fall risk plus the standard follow-up and medical care. All     patients will be assessed i) before the surgery, ii) one month, iii) 6 months, and iv) 12     months after the surgery. Assessments include: biochemical markers of bone turnover (BTM),     BMD, bone tissue biomechanical properties, hormones involved in the regulation of energy,     gastrointestinal and bone metabolism, body composition, BMI, nutritional intake, balance,     muscle strength, cardiorespiratory fitness and daily physical activity. These evaluations     will allow the investigators to understand the effects of an exercise-training program on     bone metabolism of BS patients, contributing also to further elucidate the mechanisms     underlying BS induced bone loss and fracture risk increase. The investigators will use     established methods in the literature as well as novel procedures, which will enable them to     overcome some of the limitations of previous studies. At the end of the study the     investigators expect to have collected consistent data about whether an exercise-training     program is or is not able to effectively prevent BS induced bone losses and fracture risk     increases.   "
33844|NCT02842788|"     Prone positioning has been shown to improve survival in patients with acute respiratory     distress syndrome (ARDS). However, a recent large observational study found that prone     positioning was used in only 7% of all ARDS patients, and 16% in the severe category.     However, this study did not focus on the prone position per se. In present study, the     investigators would like to explore the rate of use of prone positioning in ARDS patients and     the reasons why this treatment was not applied. The present study is one-day prevalence study     repeated four times over one year.      The hypothesis is that the rate of use of prone position is greater than 50% in the severe     ARDS category.   "
33826|NCT02843035|"     Primary Objective:      Part 1:        -  Evaluate central nervous system (CNS) biomarkers in adult Gaucher disease (GD) type 3          (GD3) patients that distinguish GD3 from Gaucher disease type 1 (GD1).        -  Screen adult GD3 patients who qualify for treatment with GZ/SAR402671 in Part 2.      Part 2:        -  Evaluate the safety and tolerability of GZ/SAR402671 in adult GD3 patients.        -  Evaluate the change in cerebrospinal fluid (CSF) central nervous system (CNS) biomarkers          from adult GD3 patients receiving GZ/SAR402671.      Secondary Objectives:        -  Evaluate the pharmacokinetics of GZ/SAR402671 in adult GD3 patients.        -  Explore the efficacy of GZ/SAR402671 in infiltrative lung disease (IDL) in adult GD3          patients.        -  Explore the efficacy of GZ/SAR402671 in systemic disease in adult GD3 patients.        -  Explore the efficacy of GZ/SAR402671 in neurological function and on exploratory CSF          biomarkers in adult GD3 patients.   "
33827|NCT02843022|"     The purpose of the study is to determine whether a web-based nursing intervention delivered     during the postpartum period will decrease symptoms of postpartum depression and parenting     stress.   "
33828|NCT02843009|"     Skeletal muscle is the largest organ in the human body and has many important roles in     determining our physical abilities and overall wellbeing. One major function of skeletal     muscle is to carry out many daily tasks, such as rising from a chair or getting on a bus,     tasks often referred to as functional abilities. During healthy ageing muscle size is reduced     by approximately 0.5-2% a year (known as sarcopenia), with concurrent reductions in     functional abilities. This can result in a reduction in quality of life and loss of     independence, both of which are clearly not desirable. The incidence of sarcopenia is around     20% between 50-70 years and around 50% in those over 80 years, with the absolute numbers and     the average age of the population rising. One method through which muscle function can be     enhanced and retard the progression of sarcopenia, across all age groups, is through     exercise. The effectiveness of exercise will depend on a number of genetic and environmental     factors, with nutritional intake being one of the most important and easily altered. Recent     research has suggested that altering the type of fatty acids consumed may have a positive     effect on muscle function. Little research is yet to be carried out in elderly humans. This     is important as that findings from animal models are not definitively transferrable to     humans. The main aim of the current proposal, therefore, is to investigate the effect the     consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), long chain     polyunsaturated fatty acids found in oily fish, on the response to a resistance training     programme in the elderly. A further aim is to determine the mechanisms which result in these     adaptive responses. The project will be centred round a large 18 week resistance     training/nutritional (EPA/DHA) intervention with both males and females over the age of 65     years. There are three main research questions and experiments stemming from this     intervention. 1) Does the consumption of EPA and DHA result in a greater increase in     strength, power and functional abilities in response to resistance training? To answer this     question a series of measures of muscular performance and functional abilities will be     assessed. 2) Does the consumption of EPA and DHA increase the size and quality of muscles,     reduce the amount of fat found within the muscle and decrease inflammation? To address this     question the participants will have MRI images of their muscles and blood samples taken     before and after the intervention. This will allow the calculation of muscle mass/fat content     and circulating levels of inflammatory markers. 3) Does the consumption of EPA and DHA     enhance the activity of the molecules involved in controlling muscle mass after a single bout     of resistance exercise? For this question muscle samples will be obtained before and after a     single training session and measure changes in molecules previously identified as important     in the changes in muscle mass in response to exercise. A fourth aim running throughout the     proposal is 4) Do males and females respond differently to the combination of EPA/DHA and     resistance exercise? Differences in protein metabolism have previously been noted between     genders and yet the investigation of these differences is often overlooked. The investigators     will investigate this by studying responses in groups of males and females. In summary, the     aim of the proposed project is to test the hypothesis that the consumption of fatty acids     found in oily fish will improve the response of an elderly population to a resistance     training intervention. The major outcome of the proposal would be in establishing a     beneficial effect of fish oil on muscular adaptation in the elderly, opening up a widely     available therapeutic strategy for an improvement in the quality of life in the elderly     population. Such strategies are of particular importance due to the increasing age of the UK     population.   "
33829|NCT02842996|"     With an ageing population, hip fractures are likely to become a significant public health     burden. Hip fracture surgery is associated with significant morbidity and mortality. Patient     outcomes and experience underpin the National Health Service (NHS) Constitution in driving     quality improvement and performance.      We aim to conduct a qualitative research study to ascertain the important patient and carer     reported experience measures following hip fracture surgery in the elderly to improve quality     of care and service provision.      To learn about patient and care-giver experience to ascertain which aspects are important to     patients and what can be improved.   "
33830|NCT02842983|"     After initial hemodynamic stabilization, 36 septic shock patients with heart rate > of 90 bpm     and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will     be randomised into two groups, esmolol group and control group. Patients allocated to esmolol     group will receive a continuous esmolol infusion to maintain a lowering of heart rate of 10%.     Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To investigate myocardial     performance, the investigators will assess Tissue Doppler imaging by echocardiography and     hemodynamic measures. Data will be obtained at baseline ,after esmolol infusion once achieved     the predefined heart rate threshold and 72hours after esmolol infusion.   "
33831|NCT02842957|"     The primary purpose of the current 6-month study is to determine the effect of an integrated,     comprehensive, individualized, intervention program including dietary, exercise, pharmacy,     and behavioral counseling on patient performance of the short physical performance battery     (SPPB) which gives an indication of an individual's ability to perform activities of daily     living dependent upon lower extremity function. Additional objectives include the impact of     the intervention on cardiovascular risk factors, and the impact of the intervention on other     indices of physical function in stage 3-4 CKD patients. The investigators hypothesize that     patients who participate in this integrated, intensive, individualized lifestyle intervention     will have higher SPPB scores compared to individuals in the usual care group. The     investigators also hypothesize that this approach will lead to higher adherence rates to the     lifestyle recommendations and that those who adhere will also show better improvements in the     measured variables over time compared to patients who are randomly assigned to the usual care     group or who comply poorly with the various study components.   "
33832|NCT02842944|"     The purpose of this study is to compare mechanical ventilation following advice from the     Beacon Caresystem to that of routine care in patients from the state of requiring invasive     mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to     routine care to investigate whether use of the system results in similar care and reduced     time for weaning from mechanical ventilation.   "
33833|NCT02842931|"     Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90     with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly     diagnosed patients with DLBCL with intermediate and high risk.   "
33834|NCT02842918|"     No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on     neurodynamic mobility, as compared to a sham intervention. This study aims to determine the     immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test     (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic limitations.   "
33842|NCT02842814|"     Whether and when systemic lupus erythematosus (SLE) patients with stable disease should     withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for     disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects     even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC     withdrawal in SLE patients with stable disease more than one year and to establish a     predictive model for flare risk stratification.   "
33843|NCT02842801|"     The purpose of the study is to identify the characteristics of young adults with pain in the     groin, lateral hip or buttock who will benefit from manipulation of the hip.   "
33845|NCT02842775|"     Cervical myelopathy is common among aging population.One of the complication of cervical     myelopathy is balance impairment.In this study, the patients with cervical myelopathy undergo     biomechanical, imaging and functional assessment. The dynamic balance training is introduced     to the patients with cervical decompression surgery.This study is expected to provide     important empirical evidence to guide postoperative rehabilitation of myelopathy patients and     improve patients' long term quality of life.   "
33846|NCT02842762|"     This study evaluates the usefulness of 3D echocardiography to guide pacemaker therapy in the     operating room in cardiac surgical patients. Each patient will serve as his own control,     following a paired design.   "
33847|NCT02842749|"     To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with     local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine     tumors.   "
33848|NCT02842736|"     The purpose of the study is to evaluate the safety and effectiveness of the Cerene     Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding     (menorrhagia) due to benign causes for whom child bearing is complete.   "
33849|NCT02842723|"     Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection     and protontherapy to management paediatric craniopharyngioma.   "
33835|NCT02842905|"     Most of us will experience some degree of hearing loss as we get older. Hearing loss can be     due to genetics, trauma, infections, exposure to loud sounds, toxins or ageing. It can affect     one or both ears and without treatment causes difficulty with following conversations in the     home or workplace. Individuals with hearing loss can seek treatment from either an     audiologist or a physician. An audiologist specializes in identifying, diagnosing, treating     and monitoring disorders of the auditory and vestibular system portions of the ear.     Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. They also     dispense, and fit hearing aids. Physicians do not provide or fit hearing aids directly,     however they diagnose hearing loss and can recommend hearing aids amongst other treatments     for hearing loss. It is undecided whether consulting with a physician in addition to an     audiologist will improve the acceptability of hearing aids to potential users compared to     consulting with an audiologist alone.      The purpose of this study is to determine whether physician involvement (in addition to an     audiologist) in the hearing aid fitting process will benefit patients. The study utilizes     questionnaires to assess satisfaction and benefit from hearing aid fittings. Furthermore,     participants decision to keep the purchased hearing aids will be recorded.      The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons and     audiologists. A hearing aid suitable for the needs of the participant will be fitted by an     audiologist. In the first 21days after the fitting, participants will attend follow-up visits     with the audiologists for adjustments to the hearing aids to best meet their specific     listening needs. After 21 days, eligible participants will be allocated to either the Control     or Test groups. During Phase II the participants will have a follow-up visit with an     audiologist (Control group) or their referring physician (Test group). During this visit     participants in both groups will be asked to describe the change in their hearing performance     related to the use of hearing aids. The study involvement time for each participant will     extend over a period of 90 days. At the study's end visit, participants will be asked to     complete a questionnaire.      The time taken to fit a hearing aid varies depending on the individual needs of the patient.     It is estimated that at most 10 visits will be required over 90 days to complete the hearing     aid fitting and study processes. These visits will be of 30 minutes duration on average,     except for the initial and final visits which lasts for 45 minutes. A patient will spend a     maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of     this time will be specifically related to the study.      Each participant is under no obligation to retain the hearing aid if s/he is not satisfied     with the hearing device, nor will any of the study investigators pressurise the participants     to retain the hearing device. The study is not intended to provide participants with hearing     aids, but rather to determine the benefit derived from hearing aids and consultations with     health professionals.   "
33836|NCT02842892|"     For optimal jumping performance an adequate interaction of muscles and tendons is required. A     parameter in the functional evaluation of both structures is their stiffness (resistance of     the tissue against deformation by external forces). It is unclear so far if higher stiffness     values of tendon or muscle or a specific stiffness relation of both tissues is the cause of     better jumping performance. The present study examines this based on the Achilles tendon and     the calf muscles or the patellar tendon and the hamstrings by three different forms of jumps     (squat jump, counter-Movement Jump, Drop-Jump).      The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional     study, the jump height of the participants will be measured for each jump form: squat jump     (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into     the knees) or drop jump (jump from small box with direct re-jump). The order of the jump form     is determined randomly. The measurements are carried out within one day. Furthermore the     international physical activity questionnaire will be used in order to assess the level of     physical activity.      As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and patellar     tendon will be detected. The measurement is carried out before the jumps (there are three     jumps after one sample jump performed). The measurement is executed non-invasively and     completely painless using Indentometers and MyotonPro. With both devices, minimal pressure on     the examined tissue will be exerted and measured how much of this can be compressed.   "
33837|NCT02842879|"     The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital.     Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score     < 6, gestational age > 41 weeks or medical indication for induction of labor.      Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.      The primary outcome will be to compare the variation of Bishop score (difference between     Bishop score before and after application of Foley catheter) between outpatient and inpatient     groups. Secondary comparisons include: mode of delivery, Foley catheter     application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and     maternal pain.   "
33838|NCT02842866|"     The aim of the study is to demonstrate non-inferiority of immunogenicity and evaluate the     safety of a single dose of MenACYW conjugate vaccine compared to a single dose of Menomune® -     A/C/Y/W-135 in adults 56 years of age and older in the US.      Primary objective:        -  To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal          serogroups A, C, Y, and W following the administration of a single dose of MenACYW          conjugate vaccine compared to those observed following the administration of a single          dose of Menomune® - A/C/Y/W-135.      Secondary objective:        -  To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A,          C, Y, and W following the administration of MenACYW conjugate vaccine to those observed          following the administration of Menomune® - A/C/Y/W-135      Observational objectives:        -  To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by          hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW          conjugate vaccine or Menomune® - A/C/Y/W-135.        -  To describe the safety profile of MenACYW conjugated vaccine compared to that of the          licensed Menomune® - A/C/Y/W-135 after a single administration.   "
33839|NCT02842853|"     The purpose of the study is to demonstrate the immune lot consistency of the antibody     responses to meningococcal serogroups A, C, Y, and W following the administration of a single     dose of MenACYW conjugate vaccine and to demonstrate the immune non-inferiority of the     antibody responses to meningococcal serogroups A, C, Y, and W following the administration of     a single dose of MenACYW conjugate vaccine vs licensed MCV4 vaccine.      Primary Objectives:        -  To demonstrate the immune lot consistency of the antibody responses to meningococcal          serogroups A, C, Y, and W following the administration of a single dose of MenACYW          conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA)          geometric mean titers.        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups          A, C, Y, and W following the administration of a single dose of MenACYW conjugate          vaccine (pooled Lots 1 to 3) compared to those observed following the administration of          a single dose of licensed MCV4 vaccine.      Secondary Objective:        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups          A, C, Y, and W following the administration of a single dose of MenACYW conjugate          vaccine (pooled Lots 1 to 3) compared to those observed following the administration of          a single dose of licensed MCV4 vaccine in the adult population (18 to 55 years old)        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups          A, C, Y, and W following the administration of a single dose of MenACYW conjugate          vaccine (pooled Lots 1 to 3) compared to those observed following the administration of          a single dose of licensed MCV4 vaccine in the adolescent population (10 to 17 years old)      Observational Objectives:        -  To describe the safety profile of MenACYW conjugate vaccine and that of the licensed          MCV4 vaccine.   "
33840|NCT02842840|"     Stroke is a major cause of morbidity and mortality, especially in low and middle income     countries including Iran. Patients with recent stroke or TIA are at high risk for new     vascular events. Several evidence based strategies in secondary prevention of stroke are     available but frequently underused. The study is aimed to evaluate an intervention to improve     patients with Stroke.   "
33841|NCT02842827|"     This is a Phase 1 open label study of the dose and duration of an orally administered LSD1     inhibitor, IMG-7289, in patients with acute myeloid leukemia (AML) and myelodysplastic     syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known     as tretinoin and Vesanoid®) in combination with IMG-7289. This study investigates the     following:        -  The safety and tolerability of IMG-7289, with and without ATRA        -  The pharmacodynamic effect of different IMG-7289 doses and treatment durations, as well          as IMG-7289 administered in combination with ATRA        -  The pharmacokinetics of IMG-2789, with and without ATRA   "
45997|NCT02683551|"     Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before     and after operation.   "
33851|NCT02842697|"     This is a prospective, multi-center trial conducted at 1 Guangzhou and 2 Beijing centers     designed to determine the diagnostic performance of virtual hepatic venous pressure gradient     (vHVPG) (investigational technology) by anatomic computed tomographic angiography (CTA) for     non-invasive assessment of the clinically significant portal hypertension (CSPH) in patients     with compensated cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by     means of catheterization of a hepatic vein with a balloon catheter is the gold-standard     method to assess the presence of CSPH, which is defined as HVPG≥10 mmHg.   "
33852|NCT02842684|"     Preoperative planning has been carried out to allow for response preparedness . A layer     technique is usually used with standard radiography .The investigators have a record of     routine preoperative radiographs by standard recognized as having an advantage over the     reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have     developed this technology and is part of the routine assessment of hip prothesis pre and     postoperatively.      The TraumaCad software can superimpose implants on Picture Archiving and Communication System     and evaluate digital and reproducible size of the implants and their correct position .      This is to demonstrate the superiority of modern digital tools in the preoperative     preparation in Orthopaedics set.   "
33854|NCT02842658|"     The purpose of this study is to determine whether a supervised exercise-training program,     initiated prior to chemotherapy induction (pre-conditioning) and continued throughout     chemotherapy treatment, can preserve short- and long-term cardiovascular performance,     skeletal muscle function, cognitive ability and quality of life better than current standard     or care recommendations for exercise during chemotherapy.   "
33855|NCT02842645|"     Children exposed to alcohol or drugs during pregnancy: Growth, health and development     Background Children exposed to drugs during pregnancy are at risk of developmental disorders.     The scope and size of this problem is poorly known in Norway.      Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is     associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the     main problem. There is less knowledge about long-term outcome of exposure to drugs during     pregnancy.      Aim The aim of the study is to investigate the physical and mental health of children exposed     to drugs during pregnancy. Identify the children's need for measures in the home and school,     and how many of the children who are taken care of in fostercare.      A sample of the children will be offered radiological examination of the brain (f-MRI). The     purpose is to study the relationship between exposure to drugs, child development,     environment and organic brain dysfunction.      Design The project is a quantitative study. The relationship between exposure to drugs and     development will be measured by questionnaires, clinical examination, neuropsychological     tests and radiological examination (f-MRI).      Children aged 2-15years who were referred, examined or treated for drug related problems at     the Department of Pediatrics, Haukeland University Hospital will be invited to participate in     the study.      Information retrieval and examination of the children are expected to be completed during     2011. Data analysis and further processing of data are expected to be completed during 2013.   "
33913|NCT02841891|"     The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled,     multicenter technical feasibility clinical study comparing standard anastomosis closure     technique (Control) to standard closure techniques plus Sylys® Surgical Sealant (Test) during     colorectal and ileorectal anastomosis procedures.   "
33856|NCT02842632|"     Training in TEE is based on hands-on training in the operation room which is time consuming     and therefore its use and experience is limited among anesthesiologists.      Recent studies demonstrate that simulation-based education is also superior to a conventional     didactic system and superior to hands-on teaching in the OR in terms of theoretical knowledge     in echocardiography. So far there is no study evaluating the study effect in obtaining the 11     basic TEE views as recommended by the American Society of Echocardiography (ASE) and the     Society of Cardiovascular Anesthesiologists (SCA) between simulator training and training in     the operation room in residents with no prior knowledge of echocardiography. The basic TEE     examination focus on the 11 most relevant views.      Therefore the investigators want to assess if there is a difference in the study effect in     obtaining the 11 basic TEE views and also in theoretical knowledge in 3 groups of residents     with no prior knowledge of echocardiography:      the simulation group (CAE Vimedix Simulator), the hands-on OR group and the online group     (http://pie.med.utoronto.ca/TEE/).      prospective randomized single-center study. The investigators want to include 51 anaesthesia     residents (17 per group) in their first or second year of training with no prior knowledge of     echocardiography in this randomized, Controlled single-centre study.      The investigators want to assess the pre- and post training scores of the theoretical     multiple choice test and the practical test in all 3 groups. The multiple choice test     consists of 50 questions with 1 point per question (max. 50 points) and the practical test is     an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix     Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria     including image angle, overall clarity and visualization of 3 major anatomic structures     pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum     of 109 (ME asc. aortic LAX has only 2 main structures). Further the time to adjust each view     and the time to complete the basic TEE Examination will be assessed.   "
33857|NCT02842619|"     The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II     as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived cells     in reconstructing bone in two clinical indications:        1. Bone augmentation (e.g. sinus augmentation)        2. Bone grafting after removal of cysts from jaws   "
33858|NCT02842606|"     Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years,     therefore, there have been considerable efforts to identify strategies for prevention and     management of risk factors. The diet, with its pleiotropic effects, is one of the most     effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers     have been extensively studied and the available evidence supports the beneficial effects of     its consumption. However, worldwide the average fiber consumption is still less than the     recommended daily dose. For this reason, the availability of functional foods, such as     additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.   "
33859|NCT02842593|"     This study evaluates the effects of two types of resistance exercise training     (higher-repetition, lower load vs lower-repetition, higher load vs control) on regional and     local measures of arterial stiffness in trained young men.   "
33869|NCT02842463|"     The purpose of this study is to determine, if it exists, a relation between plateau heart     rate from the last 3 minutes of the 6-minute stepper test and heart rate from first     ventilatory threshold from cardiopulmonary exercise testing in order to individualise     pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary     disease.   "
33937|NCT02841579|"     The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the     objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and     the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.      Safety and efficacy will also be measured.   "
33860|NCT02842580|"     The intensity of tumour response appears to be correlated with the feasibility and the     duration of a therapeutic pause or of a reduced maintenance therapy maintained until     progression in patients initially controlled by so-called induction chemotherapy.     Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has     shown that it is possible to improve the tumour response rate and patient prognosis in 1st     and 2nd lines. With a very favourable safety profile , it is an excellent candidate as     induction treatment and also as maintenance treatment. Prospective data from recent trials     have actually demonstrated improvement in PFS and/or overall survival with bevacizumab     maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy     (FOLFIRI or FOLFOX + bevacizumab).      At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line     metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab     maintenance in 2nd line metastatic, despite progression, thus appears to be a valid strategy.   "
33861|NCT02842567|"     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly     becoming the one of most common causes of chronic liver disease in children. The pathogenesis     of NAFLD is generally considered the result of a series of liver injuries, commonly referred     as multi-hit hypothesis. Several studies suggest that inflammatory pathways and oxidative     stress could be responsible of disease progression to non-alcoholic steatohepatitis (NASH).      Hydroxytyrosol is a simple phenolic compound naturally occurring in olive and olive oil with     antioxidant properties. Some studies have demonstrated that hydroxytyrosol show several     anti-inflammatory and anti-atherogenic activities, such as the inhibition of LDL oxidation     and platelet aggregation.      Alpha tocopherol (Vitamin E) is the most studied anti-oxydant in pediatric NAFLD with     conflicting results. It inhibits proinflammatory cytokine production and attenuates the     release of profibrogenic agents and liver collagen.      The purpose of this interventional study is to evaluate the efficacy and tolerability of     Hydroxytyrosol and Vitamin E in the treatment of children with biopsy-proven NASH.   "
33862|NCT02842554|"     The purpose of this study is to assess the ability of Evoked Pain Training (EPT) and Drug/     Placebo Administration (DPA) training to increase subjects' ability to discriminate between     active and placebo treatments in a double-blind crossover trial of a known analgesic,     measured by standardized effect size, relative to untrained control subjects.   "
33863|NCT02842541|"     The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and     pharmacokinetics of up to 3 dose levels of EBI-031 given as an intravitreal injection in     subjects with diabetic macular edema. There are two arms to the study, a single dose arm (1     dose) and a repeat dose arm (1 dose each month for 3 months). Eligible subjects will     initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3     dose levels. Safety will be assessed over the 28 days after the single dose prior to moving     to the next higher dose level. Once all subjects in the single dose arm have been dosed with     EBI-031 and the safety has been assessed eligible subjects will begin enrolling in the repeat     dose arm. Subjects in the repeat dose arm will receive one dose each month for 3 months and     will be assessed for safety. Escalation to the next higher dose will occur once it is     determined safe to proceed to the next dose level. Six subjects will be dosed at each of the     3 dose levels.   "
33864|NCT02842528|"     The purpose of this study is to specify the cognitive and genetic pattern associated with     alcohol dependence. Results will help identifying more precisely vulnerability factors     associated with this disorder.   "
33877|NCT02842359|"     Primary Objective:      To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each     irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients     diagnosed with hyperlipidemia, hypertension.      Secondary Objective:      To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin     fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and     hypertension, with adequately controlled blood glucose levels in groups.   "
33865|NCT02842515|"     Current endodontic treatment are based essentially on the ouster of parenchyma in case of     trauma or irreversible pulp inflammation. These situations typically affect immature teeth in     subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to     discontinuation of root development and apical closure. The challenge for the clinician in     the management of such situations is then preserving a pulp vitality. But current practices     consist in a filling of the endo-canal system with an inert or semi-inert material. In this     case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is     the study the feasibility of preparing an autologous combined advanced therapy medicinal     product (ATMP) for dental pulp regeneration in the patient with irreversible pulp     inflammation or dental trauma.   "
33866|NCT02842502|"     This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product)     production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7)     with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary     biopsies are planned to be done in order to be transferred to laboratory. Then, the     possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use     for skin substitute production in clinical condition is evaluated (primary outcome).   "
33867|NCT02842489|"     The purpose of this study is to determine whether the left lateral tilt-down position, which     includes procedures that involve placing patients on their left lateral side at an angle to     make their heads lower than their feet, is more beneficial than the left lateral horizontal     body position (patient horizontally laying on their left side, traditionally used for     colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy     procedure and patients' pain.   "
33868|NCT02842476|"     The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell     Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared     to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to     show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that     the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System will     meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2     thereby demonstrating an acceptable SpO2 accuracy performance specification.   "
33938|NCT02841566|"     The purpose of this study is to to explore the link between materialism and addiction to     gambling and money   "
33870|NCT02842450|"     The diagnosis of LAP (lesions Ano-perineal) requires the inspection, palpation, anoscopy and     possibly additional examinations including endoscopy and imaging; any of these steps of the     diagnosis can only be replaced by another.      In the absence of data in the literature on the evaluation of specific LAP Crohn inspection,     Clemence Horaist et al established definitions of these lesions inspection with the help of     an expert group, then evaluated the diagnostic agreement LAP these definitions in the same     group from a selection of photographs. Definitions ulceration, fistula, inflammatory external     os, erythema and abscess had an acceptable agreement diagnosis (kappa> 0.70)      The LAP is a predictor of severe Crohn's disease, hepato any gastroenterologist it is     appropriate that recognizes and adopts adequate care, this care has been a consensus in 2014.     The interns Hepato gastroenterology must learn during their training to know the terminology     of LAP Crohn inspection and to recognize so considered acceptable by experts.   "
33871|NCT02842437|"     The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in     patient with sepsis undergoing cleaning focus of infection.   "
33872|NCT02842424|"     Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces     progressive narrowing and occlusion of the arteries supplying the lower extremities. The most     common clinical manifestation of PAD is claudication, i.e., a severe functional limitation     identified as gait dysfunction and walking-induced leg muscle pain relieved by rest. The     standard therapies for claudication include the medications cilostazol and pentoxifylline,     supervised exercise therapy and operative revascularization. Recent data demonstrated that 24     weeks of treatment with the angiotensin-converting enzyme (ACE) inhibitor Ramipril produces     improvements in the walking performance of patients with claudication that are higher than     those of cilostazol and pentoxifylline and similar to those produced by supervised exercise     therapy and operative revascularization. The mechanisms by which Ramipril therapy produces     this impressive improvement in the functional capacity of claudicating patients remain     unknown. The Investigators hypothesize that treatment of claudicating PAD patients with     Ramipril will improve walking performance and quality of life by improving the myopathy of     the gastrocnemius. Improved myopathy is a consequence of reduced oxidative damage, reduced     TGF-β1 production by vascular smooth muscle cells and reduced collagen deposition in the     affected gastrocnemius.   "
33873|NCT02842411|"     Chronic constipation is one of the risk factors of inadequate bowel preparation, which could     influence the effect of colonoscopy. The risk factors associated with inadequate bowel     preparation in constipated patients remains unclear. Here the investigators investigated the     high risk factors which might have influence on bowel preparation quality in a prospective     cohort of patients with functional constipation.   "
33874|NCT02842398|"     The purpose of this study is to determine if selected sequence training using the Balance     Master, added to established physical therapy treatment programs, will increase gait velocity     of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their     ability to cross an intersection within the confines of community traffic signal (>120     cm/sec).   "
33875|NCT02842385|"     Changes in the marginal bone level surrounding the implant are the frequently used parameters     in assessing the short- and long-term success. Multiple biological and biomechanical factors     have been reported to adversely affect marginal bone level. Recently, initial vertical     mucosal tissue thickness has also been reported to have an impact on bone stability.The     hypothesis of present study is that soft tissue thickness on implant placement has no     positive impact of crestal bone remodeling.   "
33876|NCT02842372|"     This is a non-interventional prospective study to investigate the treatment response to     topical application with Ectoin Dermatitis Cream 7% as first-line therapy of grade I acute     skin graft-versus-host disease.   "
33879|NCT02842333|"     The investigators recently identified promiscuous HLA-DR-derived epitopes from the human     telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study     tumor-specific CD4+ T cell responses.      The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1     responses in patients in complete remission of CML two years after end of Tyrosine Kinase     Inhibitor (TKi) treatments.   "
33880|NCT02842320|"     The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic     myelogenous leukemia (CML).      Its effectiveness in controlling the progression of the disease is such that it is possible     today to consider stopping treatment in patients with deep molecular response (> RM4.0).      Only in about 50% of cases, patients relapse. It has been shown in these patients that     hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These     cells are probably at the origin of relapse. It is therefore necessary to develop     complementary therapies to cure the disease and consider discontinuation iTKs The development     of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric     antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The     membrane expression of the IL-1-RAP protein could be an interesting target.   "
33881|NCT02842307|"     This is an expertise-based randomized controlled trial. The hypothesis of this study is that     the differences in expertise of acupuncturist may impact clinical effect. In this study,     patients will be randomized to 4 group, receiving the treatment from senior acupuncturist,     junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive     the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of     treatment is from the first day receiving cisplatin until two days after cisplatin on each     group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.   "
33882|NCT02842294|"     The primary aim of this french multicenter national study is to assess and compare time to     quality of life score deterioration (targeted dimensions : global health, fatigue and     emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated     with bevacizumab in metastatic colorectal patients.   "
33883|NCT02842281|"     This study evaluates whether the gut microbiome is involved in determining whether children     with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given     fructans (a sugar often found in wheat). Participants will both receive a diet with fructans     and a diet without fructans.   "
33884|NCT02842268|"     To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after     exercise compared to the full coverage observed prior to exercise.   "
33885|NCT02842255|"     This study is about the development of a new medical device for the monitoring of of sleep     disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of     an oximeter, an actimeter in order to measure the activity level of the subject, his state of     sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).      Developing this device is realized in several steps : a study (ALMOST) is already in progress     and its goal is to acquire a database of polysomnography to create automatic algorithms in     order to detect respiratory disorders with this device under development.      The main goal of the study is to calibrate the oxymeter under development.   "
33886|NCT02842242|"     The purpose of this phase 2 open-label pilot study is to evaluate the efficacy,     pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects     with symptomatic HCM and LVOT obstruction aged 18-70 years.   "
33887|NCT02842229|"     This is a post-authorization, retrospective multicentre observational nationwide study     (PAS-OD). It will be conducted by reviewing medical records and database of patients who     participated in the validation of the psychometric properties of the GAH study     (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be     collected to ensure its retrospective nature, thereby reflecting routine clinical practice     and non-interference in the physician's clinical practice   "
33888|NCT02842216|"     Monocentric study in University Hospitals Leuven (campus Gasthuisberg).      Hospital medical records from all pregnant women who delivered between 01/07/2015 and     31/12/2015 in University Hospitals will be analyzed for the presence of medication and     supplements.      Some demographic and obstetric parameters will be collected as well.      The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be     no intervention among the selected sample.   "
33889|NCT02842203|"     This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker     and as a monitor of disease recurrence in stage III colorectal cancer (CRC).   "
33890|NCT02842190|"     Mechanical ventilation is important in the care of preterm infants with respiratory failure,     but may be associated with lung injury. Efforts are needed to avoid or minimize the use of     mechanical ventilation. However, there is no consensus on the best non-invasive ventilation     mode after extubation in preterm infants.      Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation     (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following     extubation in preterm infants ≤ 1250 g birthweight.   "
33891|NCT02842177|"     The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive     method. It is also sound safe and cheap contraceptive methods available and is nearly     maintenance free for up to 10 years.      The fear and the pain associated with intrauterine devices insertion consider barriers to     using this contraception method, this is because that the mucosal lining of female genital     tract is highly sensitive to touch and pain. However; most of small procedures done in this     sensitive area are performed without analgesia.      The pain during intrauterine devices insertion is due to application of the tenaculum ,     traction of the cervical canal, passing the uterine sound, insertion of the intrauterine     devices through the cervix, and irritation of the endometrial lining by the intrauterine     devices .      Previous studies have reported different lines to decrease pain during intrauterine device     insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or     intrauterine lidocaine and misoprostol up to paracervical blocks.      Previous studies, in literature, have found that the most painful steps during intrauterine     devices insertion were uterine sounding then intrauterine device insertion itself, followed     by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum     and a single-tooth tenaculum on pain perception during intrauterine devices and found no     difference in reported pain.   "
33892|NCT02842164|"     Induction of abortion is a hot subject that has complex and emotional controversy. The most     common time of abortion is the second trimester which represent about 10-15% of all induced     abortions over the world. As well as, two-thirds of all serious abortion-related     complications are related to induced second trimester abortion.      There are many causes for induction of abortion in the second trimester such as missed     abortion, serious fetal abnormalities such as central nervous system or skeletal malformation     and lastly some women do not wish to continue a pregnancy and will often seek out termination     of pregnancy.      Termination of second trimester is more risky than the first trimester. So many lines have     been emerged to achieve safe and effective method of termination of second trimester.      Pharmacologic management seems to be an appealing method for induction of abortion. The     combing between mifepristone and misoprostol is the effective regimen for termination of     second trimester abortion with success rate reaching about 97-99% within 24 hours.      However, mifepristone is not available or affordable in many countries worldwide so     misoprostol have been used alone but it needs higher total dose with lower effectiveness and     higher percentage of side effects rate than the combined regimens.      The optimal method for inducing second trimester nulliparous women with an unfavorable cervix     is not known. Several studies in literature have described the effectiveness of Foley's     catheter in cervical ripening and improvement of Bishop's score in women with unripe cervices     . It may act in addition to its mechanical effect by increasing the release of prostaglandin     and/or oxytocin release secondary to localized inflammation.      In practice, the insertion of intra-cervical Foley's catheter balloon is followed by applying     tension in trial to shorten the time between the insertion and expulsion of the fetus,     however; this tension adds more pain for the pregnant women with higher rate of vaginal     bleeding and dissatisfaction.      Gary et al in 2016 concluded that the application of tension did not result in faster     delivery times, but did result in faster times to catheter expulsion.   "
33893|NCT02842151|"     The purpose of this study is to evaluate current available assessments (automated vs. manual)     with which manifest refraction data and biometric variables are obtained to understand if     data from an automated refractor can be utilized to optimize the A-constant as well as manual     subjective refraction (ie, to a clinically insignificant difference). The A-constant is the     calculated number that helps the surgeon determine which IOL should be implanted in the eye     during cataract surgery.   "
33894|NCT02842138|"     This is a single arm, open-label, one center, dose escalation clinical study to determine the     safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric     Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive     B-cell lymphoma.   "
33895|NCT02842125|"     This is a Phase 1 study of the combination of Ad-p53 administered intra-arterially in     combination with oral metronomic capecitabine in patients with unresectable, refractory liver     metastases of colorectal carcinoma (CRC) and other solid tumors, including primary     hepatocellular carcinoma (HCC). This safety study has a standard 3+3 design. The Maximum     Tolerated Dose (MTD) will be determined as well as the general safety and preliminary     efficacy using RECIST 1.1 and Immune-Related Response Criteria. CEA levels will also be     followed.   "
33896|NCT02842112|"     Over recent decades, improvements have been made in the treatment of adult acute myeloid     leukemia (AML). This has been mainly attributed to improvements in supportive therapy and to     intensification of treatment strategies. The introduction of a post-induction myeloablative     regimen followed by allogeneic stem cell transplant (SCT) has reduced the relapse rate in     younger adults. However, this procedure is limited by the availability of human leukocyte     antigen (HLA)-identical donors and conventional SCT preparative regimens according to patient     age. In the absence of a compatible donor, myeloablative chemotherapy followed by autologous     peripheral blood (PB) SCT remains one treatment strategy in adult patients with AML, allowing     35 - 50% long-term survivors. Despite several advantages of the CD34+ cell mobilization     procedure, recent data have shown that relapse was higher and leukemia-free survival (LFS)     shorter compared with bone marrow (BM) autografts. Higher doses of CD34+ peripheral blood     stem cells (PBSCs) are collected to ensure engraftment and possibly reduce the incidence of     treatment-related mortality (TRM). Although there is a threshold CD34+ cell dose below which     engraftment is delayed in AML, the positive linear correlation of the number of CD34+ cells     and kinetics of engraftment reaches a limit above which an increase in the number of     progenitor cells does not provide any additional benefit. Relapse has been shown to be higher     and survival shorter for those who receive the highest CD34+ PB doses. Although highly active     against the leukemia bulk, intensive chemotherapy often spares the hardiest leukemia stem     cells (LSCs) responsible for relapse. Detection of minimal residual disease (MRD) in     autologous PBSC products may reflect inadequate in vivo purging, at least in part responsible     for relapse. Although representing a heterogeneous cell population including both normal and     leukemia cells, and despite that recent data have challenged the CD34+ CD38- phenotype of     LSCs in AML, the CD34+ CD38- cell population generally remains considered enriched for LSCs.      In this setting, MRD remaining during morphological complete remission (CR) should be     relatively enriched in CD34+ CD38- leukemia cells, and their persistence after CR achievement     should correlate with disease recurrence. This was investigated in a cohort of 123 patients     with AML following apheresis procedures after CR achievement. The investigators also studied     the impact of the infused dose of subpopulations of CD34+ PB cells on the outcome of a subset     of 71 patients who further underwent autologous PBSCT.   "
33897|NCT02842099|"     The study is a prospective, randomized phase II clinical trial, to compare the efficacy and     safety profiles of standard chemotherapy versus standard chemotherapy followed by     capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients.   "
33898|NCT02842086|"     The primary objective of this study is to assess the rates of HIV-1 seroconversion in Men     (MSM) and transgender women (TGW) who have sex with men and who are administered daily     emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir DF (F/TDF) with a     minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up.   "
33899|NCT02842073|"     This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking     of bupropion and naltrexone for binge drinkers and assess cortical adaptation to tactile     stimuli in subjects with binge drinking.   "
33900|NCT02842060|"     This study uses an interactive design and development process to develop tailored messages     that align YMSM's relationship experiences and desires with HIV prevention strategies. The     study includes a tailored online prevention, intervention, as well as an attention control     non--tailored HIV prevention (NTHP) comparison intervention. The pilot RCT will compare the     intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and     gather preliminary behavioral data to inform a subsequent application. Follow-up assessments     will be collected at thirty (30), sixty (60), and ninety (90) days post-intervention.   "
33901|NCT02842047|"     Caregivers of persons with cancer may face many challenges as they support and care for a     person receiving treatment. Sometimes having to help make treatment decisions for a patient     can cause distress for caregivers. The purpose of this study is to evaluate 2 different     electronic approaches to providing support for a caregiver. One group will have access to an     on-line program with videos, providing education on decision making strategies for caregivers     of patients with cancer, to watch and a daily meditation application and the other group will     have access to the daily meditation application. Investigators will randomly assign     participants to each group.   "
33902|NCT02842034|"     This study is to determine whether high frequency repetitive transcranial magnetic     stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia     patients   "
33924|NCT02841748|"     A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in     order to potentially improve progression free survival in a squamous cell carcinoma of the     head and neck cohort at high-risk for recurrence.   "
33904|NCT02842008|"     Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball     players. About the 85% of this population had shoulder pain in some moment of their life.     Some studies suggest that exercise is an important tool as an element to treat and prevent     shoulder injuries. For that reason, an intervention program would be a useful tool for     prevent shoulder injuries in this population.      The purpose of this study is determine the effects of therapeutic exercise program wheelchair     basketball players, in order to prevent shoulder injuries.   "
33905|NCT02841995|"     This study is being conducted to evaluate the safety, tolerability, and activity of KD025 in     adult subjects with chronic Graft versus Host Disease (cGVHD).   "
33906|NCT02841982|"     This prospective, randomized study,control study aims to compare the analgesic effect,opioids     consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al.     between single-injection QLB(quadratus lumborum block) , single-injection QLB +continuous QLB     and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic     renal surgeries.   "
33907|NCT02841969|"     More patients with diabetes mellitus have led to increasing rates of chronic non-healing     wounds. These wounds are colonised with pathogens, including multi-drug resistant organisms.     Despite repeated courses of antibiotics subsequent management is difficult due to     devascularisation of surrounding tissues and healing failures. Ultimately, patients may     require amputation. Electrolysed water is a novel antiseptic produced by passing an electric     current through a mixture of tap water and salt. Microbiocidal activity is due to the     presence of hypochlorous acid at neutral Ph. Irrigation of chronic wounds with electrolysed     water reduces bacterial load and appears to encourage wound healing. Following an encouraging     pilot study, we propose to compare electrolysed water against conventional management for     diabetic patients with non-healing foot ulcers. Adult diabetics with chronic ulcers attending     podiatry at Hairmyres Hospital will be recruited to receive regular debridement and     irrigation of wounds using either in-use product (Prontosan™) or electrolysed water as part     of a prospective randomised controlled trial. Strict enrolment criteria will be applied, with     regular clinical assessment and microbiological screening. Lesions present for >6 weeks and     >2cm will be photographed at trial entry and graded using standardised criteria. Wounds will     be monitored for at least 12 weeks (max. 20), with primary composite end-point defined as     complete healing; >50% healing of initial lesion; and/or avoidance of surgical intervention.     Secondary endpoints are surgical intervention, including debridement or amputation;     antibiotic therapy; and/or patient death. The main objective is to compare rapidity of wound     healing using either in-use product or electrolysed water. Improved healing could potentially     benefit patients who might otherwise progress to amputation. We will also monitor     antimicrobial consumption in study patients throughout the trial. A final objective is to     cost the use of electrolysed water vs cost of Prontosan in the routine management of diabetic     foot ulcers.   "
45998|NCT02683538|"     The purpose of this study is to evaluate the clinical feasibility and short-term outcome of     switching monopolar RFA using a separable cluster electrode in patients with primary and     secondary liver malignancies.   "
33908|NCT02841956|"     Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term     outcomes in young people with a first episode of psychosis (FEP). The standard of FEP care     within the US focuses on targeted provider education regarding signs and symptoms of early     psychosis to motivate patient referrals to FEP services, followed by initiation of services     within largely clinic-based settings Experience at the Early Diagnosis and Preventive     Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two     important bottlenecks to reducing DUP, consistent with reports in the literature from other     FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral     sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building     upon a comprehensive and established referral network of 20 sites across the Sacramento area     (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the     investigators will address delays in patient identification and engagement using a two-phase,     cluster randomized design. The investigators will consecutively test the impact of two     interventions to reduce DUP, defined in this RFA as time from first onset of psychotic     symptoms to engagement in FEP specialty care. To address identification delays, the     investigators will examine the use of standard targeted provider education plus novel     technology-enhanced screening compared to standard targeted provider education alone, testing     the hypothesis that the education plus technology-enhanced screening will identify more     patients, earlier in their illness. To address engagement delays, the investigators will     compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to     standard clinic-based procedures for intake, engagement and initiation of treatment, to test     the hypothesis that the mobile approach facilitates earlier and more stable engagement,     thereby reducing DUP. The proposed work will provide new specific evidence-based practices     for reducing DUP and improving outcomes through specialty care of individuals with a first     episode of psychosis.   "
33909|NCT02841943|"     Study Design: Prospective observational study      Study Location: Liverpool Hospital Intensive Care Unit, South Western Sydney Local Health     District, Sydney, Australia.      Target study size: 100 patients      Ethics: Approved by the local Human Research and Ethics Council (HREC) at Liverpool Hospital     (LPOOL) as a Low Negligible Risk (LNR) project [HREC/LNR/14/LPOOL/295, HREC/LNR/15/LPOOL47,     HREC/LNR/14/LPOOL/150]      Participants: Post cardiac surgical patients admitted to the Intensive Care Unit between     March-October 2016      Aims:        1. to determine the descriptive and predictive value of variables (outlined below) related          to oxygen delivery/consumption in regards to the effects of intravascular volume          expansion        2. to assess correlations between central and peripheral variables (outlined below)          relevant to oxygen delivery/consumption        3. to assess correlations between a set of variables (outline below) and patient centred          outcomes in ICU and in hospital      Main variables collected:        1. Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS)        2. Common carotid arterial Doppler        3. Arterial/mixed venous/central venous blood gas analyses        4. Haemodynamic parameters        5. Organ support measures      Data collection time points:        1. ICU admission (within 30 minutes)        2. Before administration of a fluid bolus        3. After administration of a fluid bolus        4. 6 hours after ICU admission        5. Morning of first postoperative day (12-24 hours)      Outcome measures:        1. the response to intravascular volume expansion        2. ICU mortality, morbidity and length of stay and hospital mortality and length of stay      Data analysis:        1. Clinical data are collected bedside using an electronic case record form        2. Descriptive statistics        3. Paired and unpaired comparative        4. Correlative and predictive statistics   "
33910|NCT02841930|"     The ActionHealthNYC program is a year-long demonstration program to improve access to high     quality health care for NYC resident immigrants who do not qualify for public insurance with     incomes at or below 200% of the Federal Poverty Level (FPL). The purpose of this study is to     determine whether improved access and care coordination services provided through the     ActionHealth NYC program allows participants to have easier access to healthcare     (particularly primary care and preventive services) than non-participants.   "
33911|NCT02841917|"     Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for     patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with     severe AS are deemed inoperable due to comorbidities such as severe respiratory disease,     chronic renal disease and peripheral vascular disease. Transcatheter aortic valve replacement     (TAVR) has emerged as a novel therapeutic modality for inoperable patients and an effective     alternative to SAVR in selected high and intermediate-risk patients. Myocardial ischemia and     reperfusion injury (MRI), mediated by reactive oxygen species (ROS), related to     cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac     surgery. In contrast to SAVR, transcatheter deployment of aortic prostheses requires shorter     time of ischemia and hypotension and may be associated with less ROS mediated MRI.     Inflammatory responses and reperfusion injury following TAVR have not been previously     described nor compared to SAVR. The aim of this study is therefore to compare the oxidative     stress response in patients with isolated severe symptomatic AS undergoing SAVR or TAVR and     determine whether it correlates with clinical outcomes.   "
33912|NCT02841904|"     This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of     non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology     results.   "
33914|NCT02841878|"     Irritable bowel syndrome (IBS) profoundly affects the quality of life. Mucosal     micro-inflammation, epithelial permeability disorder and proteases activity increase have     been demonstrated in the patients' gastrointestinal tract. Protease activity increase could     be subjected to a genetic determinism (decrease in proteases inhibitors genes expression).     Objectives: 1/ To study relations between proteases activity (in stool and colonic biopsies     supernatants), proteases inhibitors genes expression and mucosal cellular infiltrate (IBS     patients and healthy subjects). 2/ Establishing a correlation between proteases activity,     mucosal micro-inflammation and symptoms. 3/ To evaluate proteases inhibitors therapeutic     potential. Expected results: 1/ Decreased expression of proteases inhibitors genes in     subjects with IBS. 2/ Correlation of symptoms with proteases activity intensity. 3/     Demonstration of restorative potential of proteases inhibitors.   "
33915|NCT02841865|"     The Response Evaluation Criteria in Solid Tumors (RECIST), based on differences in tumor     size, has been considered as a reproducible method that facilitates not only the measurement     of the mass but the evaluation of response to given treatments; while classic chemotherapy     induces a reduction of the tumor, new target therapies frequently produce the stabilization     of the disease or a delayed progression. These new therapeutic alternatives have shade light     on the limitations of the RECIST criteria, since the response to these type of treatments are     basically associated with changes on the radiological characteristics of the tumor, as well     as other findings in functional imaging.      This study is aimed to compare the response rates according both Choi and RECIST criteria.   "
33916|NCT02841852|"     Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in     the world and the most effective drugs available to reduce gastric acid secretion. However,     studies have shown that PPIs are not always prescribed with a clear indication. Indeed,     between 25% and 86% of older individuals taking a PPI have been overprescribed these     medications. In older patients, overprescribing of a PPI is associated with increases in     morbidity, adverse drug events, hospitalization, and mortality. The hypothesis is that     overprescription of PPIs is associated with the individual multimorbidities in older patients     evaluated using the multimorbidities group criteria included in the CIRS. The aim of the     present study was to establish a relationship between overprescribing of PPIs and     multimorbidities in older patients.   "
33917|NCT02841839|"     To identify a sampling method for collecting subgingival plaque   "
33918|NCT02841826|"     The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible     contraceptive method. It is also sound safe and cheap contraceptive methods available and is     nearly maintenance free for up to 10 years.      The fear and the pain associated with IUDs insertion consider barriers to using this     contraception method, this is because that the mucosal lining of female genital tract is     highly sensitive to touch and pain. However; most of small procedures done in this sensitive     area are performed without analgesia.      The pain during IUDs insertion is due to application of the tenaculum , traction of the     cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and     irritation of the endometrial lining by the IUDs.   "
33919|NCT02841813|"     The incidence of preterm birth increases annually. Premature delivery has become the leading     cause of neonatal illness and death. For the survived premature babies, the incidence of     sequelae is also higher than the full-term babies, which brings a heavy burden to a family     and society. Preterm birth has become the important factor affecting the quality of births.     The occurrence of premature birth is the outcome of combined action of genetic and     environmental factors. However, its etiology is not clear. Recent studies have shown that the     risk of preterm birth is associated with dietary factors. Choline is an essential nutrient     for human health and it plays an important role in the growth and development of fetuses and     neonates. The investigators previously found that serum levels of free choline in preterm     mothers were lower than those in normal mothers with full-term birth. Serum levels of free     choline also reduced in preterms after receiving parenteral nutrition (PN). However, the     relationships between choline and preterm birth is not clear. Therefore, this study is aimed     to explore the effect of choline intake during pregnancy and genetic polymorphisms on the     risk of preterm birth and on the clinical outcomes in preterms receiving total PN therapy.     Healthy Chinese pregnant women with their healthy term infants will be recruited as the     control group, while Chinese women with preterm delivery and their preterm infants will be     recruited as the preterm group. Dietary choline intake during pregnancy will be evaluated by     semi-quantitative food frequency questionnaire and 24-h dietary recall questionnaire. Gene     polymorphisms in the key enzymes of choline metabolism will be identified among the     participated women and neonates through Real-time polymerase chain reaction. Choline and its     related metabolites will be assayed using high performance liquid chromatography combined     with mass spectrometry among all mothers and preterms before and after 7-days PN treatment.     The influence of genetic risk factors and metabolic changes of choline on the physical and     mental development of preterms will be evaluated. The results of this study will contribute     to a comprehensive understanding of the role of choline and the relative gene polymorphisms     on the risk of preterm birth, which will be helpful for estimating the high risk in advance.     The results will also provide the scientific evidences to establish the personalized amount     of choline intake among women and infants, optimize nutrition support for pregnant women and     preterms, and promote better prenatal and postnatal care.   "
33920|NCT02841800|"     Only a small proportion of patients with biliary obstruction caused by hepatopancreatobiliary     malignancies are suitable for surgical resection. Therefore, most patients with malignant     biliary obstruction will need palliation of their obstructive jaundice to relieve the     symptoms and prevent life threatening complications such as biliary sepsis. The endoscopic or     percutaneous/transhepatic routes, such as endoscopic retrograde cholangiopancreatography     (ERCP) and percutaneous transhepatic cholangiography (PTC), and stents are accepted     approaches for the relief of jaundice in malignant biliary obstruction. Improvement in the     bilirubin level is also essential before palliative chemotherapy is considered in these     patients. However, tumor ingrowth still remains a major cause of obstruction. In this trial,     the investigators will use HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for     the endobiliary radiofrequency ablation (RFA) treatment as a form of neoadjuvant therapy in     hepatopancreatobiliary adenocarcinoma.   "
33921|NCT02841787|"     The goal of this field trial is to tailor and test a web-based intervention in adults 65     years of age or older. Two versions of the web-based intervention have been created and will     be tested--one with an online social network and one without an online social network. The     purpose of this study is to: pilot a novel intervention, examine methods to improve adherence     to web-based interventions (e.g., peer network); collect data on feasibility, acceptability,     and efficacy of an web-based intervention for late life depression; and ultimately, to     overcome the numerous barriers to treating depression in later life.   "
33922|NCT02841774|"     HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin     therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily)     in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease     (CHD).   "
33923|NCT02841761|"     The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of     midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577     when administered alone and in combination with midazolam.   "
33925|NCT02841735|"     It is important to explore use of technology to reduce drinking. The purpose of this research     study is to compare different types of mobile technology for their effects on alcohol     drinking and ratings of usability among young adults.This study will be conducted in four     phases: a web-based screening assessment; brief appointment on the day of the alcohol     drinking session; alcohol drinking session; and a follow-up appointment. Participation in     this study will last approximately two months.   "
33926|NCT02841722|"     The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or     febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in     dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical     response. To avoid those episodes, or to shorten the duration and reduce the associated risk,     administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended. Recombinant     G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the     proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily     administration (such as filgrastim, lenograstim) and a single administration (pegfilgrastim).      Various international learned societies offer recommendations for primary care, secondary or     curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal     time for the administration of growth factors and duration of administration are not very     clear. If it seems clear that the treatment should not be initiated within the first 24 hours     following administration of chemotherapy, summaries of the characteristics of different     products do not provide evidence to optimize the administration day depending on the kinetics     evolution of neutrophils. In addition, no information is given as to the choice of a     formulation with respect to the other.      The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the     evolution of neutrophil function of time and explain the pharmacodynamic variability during     the administration of chemotherapy based on eribulin. The description of the evolution of     neutrophils when growth factors are administered give the opportunity to streamline     administration regimens of these factors and to provide guidance on the circumstances in     which they should or should not be given while weekly chemotherapy.      Expected benefits and foreseeable risks With the exception of surplus withdrawals during the     first 2 cycles of treatment, this study will have no impact on the care of patients.   "
33927|NCT02841709|"     The primary objective of this study is to assess the effect of ACT-541468 on a measure of     sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in elderly subjects     with insomnia disorder.   "
33936|NCT02841592|"     This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen     content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device     at the flush rate, used with active positive pressure assistance.   "
36207|NCT02811848|"     The purpose of this study is to develop and pilot test recruitment methods for a future study     of prevention of sexually transmitted infections (STI), including the human immunodeficiency     virus (HIV), among Black adolescent boys through sexual health education by their fathers.   "
33928|NCT02841696|"     Hypertension is a major cardiovascular risk factor. Heart failure is one of its main     complications but the factors that influence its development are still insufficiently known.     The primary objective is to determine associated factors to the occurrence of left     ventricular (LV) systolic dysfunction assessed by an alteration of the Global Longitudinal     Strain (GLS) after more than the years of hypertension. The secondary objective is to     estimate the prevalence of LV systolic dysfunction in a cohort of hypertensive people     followed for over 10 years and formulate pathophysiological hypotheses on the development of     this heart disease.   "
33929|NCT02841683|"     Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS),     was developed in France to provide an adapted web and mobile application support to smoking     cessation for all adults smokers, with or without chronic diseases, who want to stop smoking.     This paper presents the study protocol of the evaluation of the program. The primary     objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The     secondary objectives are to 1) describe efficacy variations in regard to user     characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of     use, social or environmental contextual factors likely to influence the efficacy of eTIS, and     the behavior change techniques (BCTs).      Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial     including a process evaluation with at least 3000 participants randomized to the intervention     or to the control arm (current practices presented in a non-interactive website). Inclusion     criteria are: Adults, Smokers with an information and consent form completed, Getting a     smartphone and using mobile applications, wanting stop to smoking in short, medium or long     terms. The exclusion criterion is the refusal to participate in the study. The primary     outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary     outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence     abstinence of 30 days at 12 months later, number of quit attempts during the study,     progression of stages within the program (changes and duration in each stage). Data will be     analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression     will be carried out to estimate an OR [95% confidence interval] for efficacy. A multivariate     multilevel analysis will explore the influence of patients' characteristics, social and     environmental context, conditions of use and behavior change techniques on results.      Dissemination -The findings of this study will allow us to understand and characterize the     efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological,     environmental and contextual factors, which could influence the efficacy of this type of     intervention on smokers. These findings will be disseminated through peer-reviewed journals,     national and international conference presentations and public events.   "
33930|NCT02841670|"     This is a monocentric, longitudinal, prospective, observational post-market follow-up study.      30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the     cataract procedure, data collection will take place during visits planned by the physician as     part of normal follow-up.      Patients with cataract will be recruited from the clinic by the investigator based on the     inclusion and exclusion criteria.      The patient will be followed up after one day, one week, one month, six months, one year and     three years post-op. An interim analysis will be performed with one-year clinical results.      The main objective of the study is to evaluate is to evaluate efficacy and long-term safety     for the InFo - Instant Focus © lens.   "
33931|NCT02841657|"     -  To compare surgical and oncological outcomes in patients underwent to colorectal          resection with 3D vs 2D laparoscopic technique.        -  To evaluate the visual overload in surgeons using 3D laparoscopic technique.   "
33932|NCT02841644|"     For the last 70 years, orthopaedic dogma has dictated that all injuries that penetrate the     joint capsule require formal irrigation and debridement in the operating room to minimize the     risk of developing septic complications. The literature supporting this practice is sparse     and stems primarily from wartime injuries that may not be generalizable to the smaller, less     contaminated arthrotomies seen in the civilian population. Despite the classical teaching of     all traumatic arthrotomies requiring irrigation, debridement, and closure in the operating     room, numerous surgeons around the country are beginning to treat small traumatic     arthrotomies without surgery. The purpose of this study is to evaluate the cost of treatment     as well as incidence of adverse events, such as the development of septic arthritis, in     patients undergoing operative and non-operative treatment of traumatic arthrotomies.   "
33933|NCT02841631|"     Human Papilloma Virus (HPV) has been shown to be a cause of Head & Neck Squamous Cell     Carcinoma (HNSCC) and the majority of current studies focus on what is happening in patients     with a HPV HNSCC. But there is limited investigation into HPV infection in the oropharynx of     patients who do not have HNSCC. The current incidence of oral HPV infection is not known in     the general population locally and there is also limited information on what particular     localities within the mouth that patients' harbour HPV infection what strains are present and     if there are any differences in viral load.      Therefore the aim of this project is to investigate within patients that undergo     tonsillectomies the rate of HPV infection in tonsils to determine the amount of HPV present     within the community.   "
38748|NCT02778425|"     This study compare the efficiency of partial splenic embolization +endoscopical therapy with     endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with     splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.   "
33934|NCT02841618|"     The purpose of this study is to understand how consuming healthy cookies every day for two     weeks will affect different types of fat in the blood. Specifically, the overall goal of this     study is to find out if the healthy cookies can increase a polyunsaturated fat called     linoleic acid in plasma, red blood cells and white blood cells.   "
33935|NCT02841605|"     The close homology between the central and enteric nervous systems suggests that a disease     process affecting the central nervous system could also involve its enteric counterpart. The     investigators have recently shown in that the enteric neurons can be readily analyzed using     routine colonic biopsies. This led us to propose that the enteric nervous system could     represent a unique window to assess the neuropathology in living patients with a     neurodegenerative disorder. The investigators have already used this approach to show that     Parkinson's disease pathology was recapitulated in a single colonic biopsy. By contrast to     Parkinson's disease, the detection of Alzheimer's disease (AD) pathology in the enteric     neurons has so far failed. This may be due to the low number of human tissue samples in     addition to the low sensitivity of the immunohistochemical methods that were used. The aim of     the current research project will be therefore to reevaluate AD pathology in a large number     of human colonic samples using both a morphological and biochemical approach .      The enteric nervous system could represent a unique window to assess the neuropathology in     living patients with AD. This might open the way to the development of novel AD biomarkers     that will directly assess the neuropathological process.      Main Aim : To Analyze the presence of beta-amyloid pathology in the enteric nervous system     (ENS) in AD patients      Secondary Aim(s):        1. To analyze and describe the presence of tau in the enteric nervous system (ENS) in AD          patients        2. To assess neuronal loss in submucosal tissue in AD patients.        3. To examine Glia cells in the enteric nervous system in AD patients..   "
33939|NCT02841553|"     In this study, the investigators hypothesize that studying monogenic variants with strong     effect associated with severe insulin deficiency of Wolfram syndrome will provide important     insights into the more complex type 1 and type 2 diabetes mellitus.      Aim 1. Establish and maintain a registry of patients with Wolfram syndrome. An Internet based     registry will be employed to enroll participants with the clinical diagnosis of Wolfram     syndrome (insulin dependent DM and bilateral OA). Clinical information regarding age of     diagnosis and progression of the disease will be collated and analyzed to better define its     natural history, along with potential metabolic phenotypes such as glucose intolerance of     heterozygous parents and unaffected sibs.      If not already completed, blood for WFS1 sequence analysis will be obtained on the     participants (parents and sibs also for control purposes) and sent to a CLIA certified lab to     define the mutation. This information will benefit patient families and referring physicians     by providing a genetic diagnosis and where indicated. The Wolfram Syndrome Registry will     foster international collaborations to more efficiently and systematically collect Wolfram     syndrome patients and their clinical and experimental data.   "
33940|NCT02841540|"     This study will include a Phase 1 dose-finding portion (Cohorts A and B) and a four-arm     expansion portion. The primary objectives of the study are to determine the maximum tolerated     dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-8800 administered orally in     participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic     Myelomonocytic Leukemia (CMML) and to assess the safety and tolerability of H3B-8800 as a     single agent administered orally once daily on a 5 days on/9 days off repeated dosing     schedule in 28-day cycles in participants with MDS, AML, or CMML.   "
33941|NCT02841527|"     Obesity is an increasing health problem in the United Kingdom (UK) and is predicted to     worsen.      In the UK and worldwide the three most commonly performed operations are laparoscopic     adjustable gastric banding ('BAND surgery'), laparoscopic gastric bypass ('BYPASS') and     laparoscopic sleeve gastrectomy ('SLEEVE'). All lead to weight loss, but they are associated     with different problems. This study (BYBANDSLEEVE) is a randomised trial with a target     recruitment of 1341 patients in eleven hospitals and its aim is to compare the effectiveness,     cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery.   "
33942|NCT02841514|"     Study title: The Efficacy and Safety of tooth bleaching procedure using Y10 Whitening     toothpaste and RF current      The Device: The Brighttonix Y10 Tooth Whitening system is indicated for use in painless     non-invasive tooth whitening treatments.      Design: Single center, randomized, controlled, double blind, two-arm, prospective clinical     study.      Follow up visits at 7 days (phone visit), 12 weeks and 26 weeks.   "
33943|NCT02841501|"     This is a prospective case-control physiopathological study, which main objective is to     determine the genetic host factors predisposing to candidemia. Secondary objectives are to     develop new diagnosis tools using the biological collection, to describe and update     epidemiology, to analyse the influence of genetic polymorphisms on prognosis.   "
33944|NCT02841488|"     This project is one of four components of a thematic project that aims to evaluate the use of     ultrasound in regional blocks, called Use of ultrasound in regional blocks and injections     for the treatment of acute and chronic pain.      It will evaluate quantitative and qualitative control of ischemic pain in the lower limbs in     patients with peripheral arterial occlusive disease through continuous sciatic nerve block by     perineural catheter, popliteal approach, compared to systemic analgesia based on opioids.   "
33960|NCT02841267|"     The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that     neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular     Dystrophy 2I (LGMD2I) to preserve and/or improve muscle function.      This study will provide the clinical assessment of the safety, tolerability, Pharmacokinetics     and Pharmacodynamics of PF 06252616 following repeat IV doses in ambulatory adults with     LGMD2I.   "
33945|NCT02841475|"     Atrial fibrillation (AF) is a common condition whose prevalence increases with advancing age     . One of the main complications of this arrhythmia is the occurrence of systemic     thromboembolism, the first of which the occurrence of cerebrovascular accident (CVA) . The     advanced age itself is an independent risk factor for occurrence of stroke in the context of     AF , evidenced by the score awarded to the age over 75 years in the risk estimate     thromboembolism in the score CHA2DS2-Vasc . Making the elderly a priority target for the     prevention of thromboembolism, both because of the increased thromboembolic risk and     prevalence of AF in this population. For many years, vitamin K antagonists (VKA) have proven     their effectiveness in this context . But the effectiveness and safety of thromboembolism     prevention by anti-vitamin K treatment involves maintaining the INR (International Normalized     Ratio) in the therapeutic range. Indeed occurred of a thromboembolic or haemorrhagic adverse     event directly correlates to having an INR outside the therapeutic range and maintaining the     INR in the therapeutic range is subject to many variations inter- and intra-individual. They     include, genetic factors , food , drug interactions , as well as disease processes . Or one     of the elderly characteristics is the coexistence of multiple pathological processes or     comorbidities . The supposed interaction between comorbidities and variability of INR has     been little studied: Only a few studies have examined the factors associated with the     stability of the INR and unstable . The identification of patients at risk of instability INR     yet allow clinicians greater vigilance and better identification of patients for whom the     initiation of treatment with vitamin K does not appear the best therapeutic strategy.      Our study seeks to determine whether comorbidity, assessed by the Charlson comorbidity index,     are associated with instability of the INR, among more than 80 years for patients treated     with AVK atrial fibrillation.   "
33946|NCT02841462|"     The overall objective of this trial is to explore the dose-tolerance (safety) and     dose-response (efficacy) of single 3-minute intra-bursal perfusions of a physiological saline     solution at increasing temperatures.   "
33953|NCT02841358|"     Niemann-Pick disease, Type C is a rare genetic disorder characterized by a failing in     intracellular cholesterol transport, inducing an accumulation of sphingolipids in the brain.      Neurological signs are at the forefront of the disease. There are also psychiatric signs of     psychotic kind among 28 to 45 % of patients according to studies, and a thirty cases were     published. These signs can be concomitant with neurological signs or precede them.      Is is likely that psychotic disorders are the first signs of a Niemann-Pick disease not yet     non encore diagnosed for some patients. Yet, no prevalence study for this disease in a     psychiatric population of patients currently exists. In response to this problem this study     proposes to search patients whose disease could be of organic origin or patients whose     disease is suspected, based on clinical data. The diagnosis will be confirmed certified with     a genetic and/or biochemical test.   "
33997|NCT02840773|"     The aim of the present study was to determine the levels of sRANKL and OPG as well as their     relative ratio in PICF surrounding the two different types of implant-abutment connections on     short implants after a 12-month monitoring period. Additionally, their association with     clinical findings and microbiological markers in plaque samples were assessed in the present     study.   "
33947|NCT02841449|"     The aim of this study is to investigate whether hydration status affects blood sugar control     and appetite regulation. In order to do this, participants will undergo a monitoring phase     whereby their weight, diet and physical activity are monitored, followed by a dehydration     protocol involving fluid restriction and sitting in a heat tent. In one arm of the trial,     participants will remain dehydrated for the remainder of the day (i.e. after the heat tent)     by having their fluid intake restricted, and in the other arm of the trial, participants will     be rehydrated by consuming the necessary amount of plain water. All participants will undergo     both arms of the trial, the order of which will be chosen randomly.      Several measures will be taken throughout the trial. Before participants go into the heat     tent, they will provide a urine sample (for baseline hydration status as indicated by urine     osmolality), a blood sample (for glucose, insulin, arginine vasopressin,/copeptin, ghrelin     and serum osmolality and plasma volume), and have a peripheral quantitative computer     tomography scan of their thigh to indicate muscle size. On the day proceeding the heat tent,     participants will have these measures repeated, along with metabolic rate before consuming a     75 g glucose drink, followed by 15 minutely blood samples and hourly metabolic rate measures     for 120 minutes (i.e. an oral glucose tolerance test; OGTT). Following this, participants     will be presented with a large bowl of pasta and sauce and will be instructed to eat until     satisfied (maximum 30 min). Blood samples will be taken every 10 minutes for 60 minutes     following the meal.      Participants also have the option to opt-in to have a muscle biopsy taken. This will be taken     before and ~120 minutes after the glucose drink.   "
33948|NCT02841436|"     Pancreatic cancers is one the most important malignancies with highest mortality in the     world. The prognosis of these patients is very poor. Although some patients with     early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of     patients present with locally advanced or metastatic status are inoperable. Patients in this     late status usually are recommended to receive palliative bypass operation such as     choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the pancreatic     cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy. However,     the main drawback of RFA is its side effect to damage adjacent structure such as bile duct,     and the tumors located adjacent to vessels could not be ablated well.   "
33949|NCT02841423|"     Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac     surgery is a common problem.      Therefore,this study was designed to assess POCD after closed-loop coadministration of     propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia     in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local     ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical     status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into this     pospective randomized monocenter study. Patients received anesthesia 3 days after using a     neuropsychological test battery.   "
33950|NCT02841410|"     This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision     making when evaluating the healthiness of food products with nutritional information     displayed either with a Traffic Light system, a colored nutritional label, and a Guideline     Daily Amount system, a numeric label.   "
33951|NCT02841384|"     Introduction: Patellofemoral pain syndrome (PFPS) is related to the previous sore knee,     change functionality and postural control deficits. One of the possibilities for pain control     and better positioning of the patella is the rigid bandage patellar widely used by clinicians     and researchers.      Objective: To evaluate the effect of rigid patellar bandage on postural control, pain and     function in sedentary women with PFPS.      Methods: The sample will be composed of 30 volunteers, sedentary, between 18 and 55 years;     randomized group Bandage Functional Rigid (n = 15) and Banding Placebo (n = 15). All fill the     Personal Data Sheet, Visual analog scale Pain Questionnaire Previous Knee Pain Scale; and     will be submitted to analysis of postural control (static and dynamic) and carry out the test     and sit up in pre conditions and post application of the bandage.      Hypothesis: Expected to observe the effect of rigid patellar bandage in pain, function and     postural control in sedentary women with PFPS.   "
33961|NCT02841254|"     Meningitis are serious infections. Evidenced by high rates of mortality and sequelae.     However, these diseases have a relatively small impact. Also physician services Home     Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis.     Indeed, it is only after this essential clinical milestone that will be carried out a lumbar     puncture which will confirm the diagnosis and to quickly begin treatment.      Unfortunately, if recent studies can improve the therapeutic management of patients with     meningitis, no study was interested in yet fundamental step of diagnosis.      It seems therefore necessary to achieve a prospective clinical study to reassess the adequacy     of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve a     predictive clinical score of the presence or absence of meningitis.   "
33952|NCT02841371|"     Chronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in     adults in China was 10.8%. Albuminuria measurement and estimating glomerular filtration rate     (GFR) are the primary means of screening for CKD in epidemiological investigations. However,     there are many important problems to be solved, whether albuminuria test or GFR evaluation.     The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months,     with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein     excretion rate (PER) and 24-hour albumin albumin excretion rate (AER) to compare the effects     of different times of screening for CKD and observe the daily physiological variation of ACR,     PCR, AER and PER, derive ACR and PCR reference value on the basis of different genders, in     order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment of     GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP)     based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid (DTPA)     renal clearance method. Then to develop GFR estimation equation based on the combination of     serum creatinine, cystatin C, β2 -microglobulin and BTP applicable in China.   "
33966|NCT02841189|"     This is a single center trial to evaluate the performance of the King Vision video     laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the     performance is satisfactory, this device may become a standard laryngoscope for tracheal     intubation in elective and emergent tracheal intubations.   "
33954|NCT02841345|"     In the case of psychotic disorders such as bipolar disorder or schizophrenia, attention     dysfunction contribute, according to the theories of neuroscience, the development of mood     disorders following disturbances in the interaction-care emotion. In this context, the     general objective of this research project is to refine our understanding of the similarities     and distinctions between bipolar and schizophrenic patients in the basic emotional     information processing. Specifically, these are: 1) to better understand what level of basic     emotional information processing both conditions differ or are comparable and in what sense     and 2) estimate, in both pathologies, the specific influence of the nature of the task of     processing emotional information. To answer these questions, the investigators have developed     a protocol to specifically target different information processing channels playing on the     nature of the spatial frequency content of emotional natural scenes. To estimate in both     pathologies, the specific influence of the nature of the task on emotional processing, 3     types of tasks are proposed: 1) a simple task perception and 2) -3) two tasks whose     categorization one focused on the emotional feelings of the individual and the other on the     tendency to action. Both tasks categorization should involve more specifically the     ventromedial prefrontal cortex (CPFVM) and the dorsolateral prefrontal cortex (DLPFC)     respectively. All patient data will be compared with data from healthy control participants.   "
33955|NCT02841332|"     The purpose of this study is to estimate the capacity of the multimodal imaging parameters     measured at 15 days and 2 months of initiation of treatment with bevacizumab, to measure     changes in clinical status (sensitivity to measure changes) in patients treated for recurrent     glioblastoma.   "
33956|NCT02841319|"     The investigators have planned a research on the effects of virtual reality therapy and home     exercise program on hand functions in children with hemiplegic cerebral palsy in Istanbul     University Istanbul Faculty of Medicine in the Department of Physical Medicine and     Rehabilitation. The eligible patients will be randomized into two groups. The patients in     intervention group will participate in a computer based virtual reality exercise program for     a period of 8 weeks supervised by the investigators. In addition, these patients will receive     a home exercise program. The patients in the control group will receive only a home exercise     program for 8 weeks. All patients will be evaluated before treatment, immediately after     treatment, and 3 months after the end of the treatment.   "
33957|NCT02841306|"     20 patients presenting a rhegmatogenous retinal detachment with more than 4 days of duration     will be prospectively included.      A single dose of ursodeoxycholic acid will be administered orally before surgery at different     time-points in 16 subjects. Standard surgery will be performed and ocular samples will be     collected during the procedure. Ursodeoxycholic acid treatment will be continued in treated     patients during 3 months after surgery.      Ocular and serum samples from the 4 untreated patients will serve as negative controls for     the determination of UDCA levels.   "
33958|NCT02841293|"     The originality of the GRECCAR project is to propose a holistic approach of the evaluation     combining the paradigms of surgical efficacy, costs, quality of life and oncological     adequacy, reflecting real life.   "
33959|NCT02841280|"     It is estimated that in the United States there are approximately 8 million individuals who     have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and     is often poorly controlled due to an expanded volume state; diuretics are frequently     prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but their     use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are less     potent, their use may be associated with less acute kidney injury, but as yet there are no     firm data to support that thiazide diuretic therapy can improve BP among subjects with     advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in advanced     CKD either alone or in combination with loop diuretics and concluded that thiazides may be     useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and weight     loss by 1-2 kg in observational studies. Observational data show that thiazides lead to an     improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic whereas     randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had only     between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate their     safety and efficacy in moderate to advanced CKD.   "
45071|NCT02695719|"     The purpose of this study is to evaluate the efficacy and safety of oral administration of     lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic     constipation (CIC) compared with placebo.   "
33962|NCT02841241|"     This is a prospective, single arm, roll-in study of esmolol infusion for patients with     septic shock with persistent tachycardia after adequate intravenous volume expansion. The     study will evaluate the adequacy and efficiency of study protocols for the anticipated, main     ECASSS study, which will have a separate entry in clinicaltrials.gov.   "
33963|NCT02841228|"     Lung cancer is one of the most common cancer and the leading causes of cancer death in     worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with     LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous     integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing     the radiation dose and benefit for inoperable NSCLC patients.   "
33964|NCT02841215|"     Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment.     Ivermectin is a recommended treatment in common forms of scabies and represents a promising     treatment in crusted scabies in case reports. However, response to ivermectin remains     variable among studies, and there is no consensus on the schemes to adopt (dosages and     administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in     head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg     ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of     scabies (crusted and profuse).   "
33965|NCT02841202|"     The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula,     retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT).     The present clinical study is the first research reported in the literature which is     investigating the posterior ocular segment changes in women using OCP by using OCT.   "
33995|NCT02840799|"     This trial seeks to assess if potassium nitrate (KNO3) therapy improves exercise capacity and     oxygen uptake in heart failure patients with preserved ejection fraction (HFpEF).   "
33967|NCT02841176|"     This study will be an open label pilot study to explore the utility of thermography in     assessing response to Golimumab treatment in Psoriatic Arthritis (PsA). Ten patients     fulfilling the Classification criteria for Psoriatic Arthritis (CASPAR) for Psoriatic     Arthritis with active disease and eligible for anti-TNF therapy will be invited to     participate in this study. They will be assessed at 4 time points during the study: prior to     their first anti-TNF medication (screening and basal visits), and subsequently within 5 days     after their 2nd and 4th doses of monthly Golimumab.   "
33968|NCT02841163|"     Measurement of herniated disc resorption and assessment of satisfaction regarding     post-treatment state and integrative Korean medicine treatment through phone interview in 500     patients with MRI follow-up results receiving treatment for lumbar and cervical disc     herniation at Jaseng Hospital of Korean Medicine.   "
33969|NCT02841150|"     The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of     ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.   "
33970|NCT02841137|"     This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg     tablets compared to progesterone 100 mg capsules on the endometrial thickness of     post-menopausal women under hormone therapy with estradiol.   "
33971|NCT02841124|"     The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer     is a complex process that is always painful for patients, relatives and professionals. For     more than 10 years, shared decision making has been more and more emphasized. However, few     data in the literature rely on clinical research. In order to understand their difficulties     and issues, this study explores the determinants and modalities of DLWT and analyses the     feasibility of different methods for investigating this decision making process.   "
33972|NCT02841111|"     Kidney transplantation is the treatment of choice for ESRD. However, the life expectancy of     kidney transplant patients is lower than that of the general population. Deaths recipients     are due mainly to cardiovascular diseases related to a chronic inflammatory state. In     addition, renal transplant patients frequently have anemia, identified as an independent     cardiovascular risk factor that can be corrected by blood transfusion.      But the relationship between transfusion and inflammatory condition are bidirectional. The     patient's inflammatory condition will sound on the effectiveness of transfusion and     transfusion could trigger an inflammatory condition. This has been reported with the said     blood components aged, especially with packed red cells in patients hospitalized in     intensive care after heavy heart surgery.The main objective of this study is to evaluate the     impact of early transfusions on the evolution of renal transplantation (ie death, anti-HLA     immunization, acute rejection, graft loss, delayed graft function, cardiovascular events )     taking into account in the analysis: patient age at the time of transplantation, the number     of incompatibility (s) (HLA class I and / or II) between the graft and the patient and sex of     the recipient.      This is a multicenter retrospective observational study (descriptive epidemiological     study).The impact of early transfusions is determined retrospectively over a period of 6     years from 01 January 2002 to 31 December 2008, in renal transplant patients of all centers     of France met the criteria for inclusion. This cohort represents about 12 000-14 000 patients   "
33973|NCT02841098|"     The purpose of this study is to determine whether carotid surgery combined with optimal     medical therapy improves long-term survival free of ipsilateral stroke in patients with     asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared     with optimal medical therapy alone.   "
33974|NCT02841085|"     Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or     identifying genes involved in subjects at high risk for thrombotic and in whom screening for     detectable hereditary thrombophilia was negative.   "
33975|NCT02841072|"     The primary objective of this study is to document the rates of success and serious     complications among women having outpatient medical abortions with 200 mg mifepristone + 800     buccal misoprostol at 64-70 days of gestation.   "
34009|NCT02840617|"     This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence     imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the     ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be     possible to use fluorescence navigation system in helping prostate biopsy and lymph node     dissection in the future.   "
33976|NCT02841059|"     In this prospective, comparative non-randomized multiple teaching hospitals study, the     investigators try to determine the relationship of total hysterectomy and Taiwanese female     pelvic floor and sexual function from the view of epidemiology and clinical survey. This is     an important issue that related to female autonomy, health care resources and even national     health policy. The study results will help to understand whether there is unnecessary part in     the current hysterectomy procedures and its potential health hazard.   "
33977|NCT02841046|"     To evaluate the application of fluid-infusion therapy with the combination of stroke volume     variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients     underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old,     cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into     two groups randomly: group C with CI as the primary judgment and group S with the combination     of SVV and CI as the primary judgment.   "
33978|NCT02841033|"     Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly     for two months, then every 2 weeks for four months, then once each month. Study treatment may     continue until disease progression, unacceptable toxicity, or decision to withdraw from the     trial. Disease evaluations will be performed every three months until disease progression.   "
33979|NCT02841020|"     The purpose of this study is to determine if biopsy for non-neoplastic renal disease for     patients with a small renal mass results in greater postoperative renal function than the     current standard of care (no additional biopsy).   "
33980|NCT02841007|"     The geko™ device is indicated for the prevention and treatment of oedema. The aim of this     study is to show that recruiting, and performing study assessments in ankle fracture patients     requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to     obtain data to support the powering of a larger study to demonstrate the effectiveness of the     geko™ device at reducing length of stay for this population of patients. This study will also     allow us to assess the acceptability, tolerability and compliance of treatment with the geko     device.   "
33981|NCT02840994|"     The objective of the proposed clinical study is to investigate the safety and tolerability of     CV301 in combination with OPDIVO® (nivolumab), an anti PD1- inhibitor, compared to nivolumab     alone in subjects with previously treated non-small cell lung cancer (NSCLC). The clinical     study is designed to evaluate the possible enhanced antitumor activity of CV301 with     nivolumab compared to nivolumab alone in a setting in which nivolumab is the     standard-of-care, second-line therapy, for metastatic NSCLC. The rationale for combining     CV301 with nivolumab is based on the hypothesis that CV301 can induce specific immune     response in the tumor, and that in combination, nivolumab may augment the T cell-mediated     immune response generated by CV301 by blocking the inhibitory signal of the PD-1.      The study will include a Phase 1 dose escalation part to assess the safety and tolerability     of CV301 alone, prior to moving into the combination with nivolumab (the Phase 1b component).     The Phase 1 part of the trial will be followed by a Phase 1b component to test in a single     arm lead-in stage the safety and tolerability of the combination treatment, i.e. CV301 plus     nivolumab, before expanding the number of patients to be treated in the randomized Phase 2     part of the trial. The objective of the Phase 2 is to assess the safety and preliminary     efficacy of CV301 in combination with nivolumab compared to nivolumab alone in subjects with     previously treated NSCLC.   "
33982|NCT02840981|"     The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary     characteristics in Mediterranean countries, is associated with high antioxidant capacity     linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA)     availability and oxidation in mitochondria, thus reducing the production of the reactive     oxygen species (ROS) superoxide, and promoting cellular health. To assess the adherence to     the MD, a simple 14-item questionnaire had been tested in different settings by the PREDIMED     (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial. On the     other hand, to allow a more an accurate measurement of the actual macro and micronutrient     intakes, including dietary anti-oxidant micronutrients, the 7-day food records is considered     as the gold standard of self-administered food frequency questionnaires.      Circulating levels of Sirtuin 4 (Sirt4), part of a complex of proteins that control diverse     biological processes, including lipid metabolism, are low in obese patients, as a possible     attempt to decrease fat oxidative capacity and mitochondrial ROS production, however     promoting ectopic liver fat storage.      The phase angle (PA), a measure determined by bioelectrical impedance analysis (BIA), and the     visceral adiposity index (VAI), a gender-specific mathematical index based on simple     anthropometric and metabolic parameters, represent well-validated, reliable and widely used     markers of cellular health and ectopic adipose distribution and function, respectively. The     fatty liver index (FLI) is a surrogate measure for fatty liver recently proposed as an     independent predictor for diabetes mellitus.      Aim of the present study was to investigate in adult obese individuals the levels of Sirt4     according to the adherence to the MD evaluated by PREDIMED questionnaire, focusing on the     possible association with single dietary components evaluated by 7-day food records, and to     evaluate the association between circulating levels of Sirt4 and PA, as marker of cellular     health, VAI, as index of adipocyte dysfunction, and FLI, as a predictor of fatty liver.   "
33983|NCT02840968|"     In this cross-sectional observational study the investigators evaluated the association     between the adherence to the MD and PhA in a sample of adult population, stratified according     to categories of sex, age, and BMI.   "
33984|NCT02840955|"     Colonization with Staphylococcus aureus is related to inflammation in atopic dermatitis.     Gladskin is a product for topical use containing the proprietary enzyme Staphefekt SA.100,     which has the ability to specifically lyse the cell wall of S. aureus. The investigators     hypothesize that Staphefekt decreases S. aureus colonization of the skin and consequently     decreases symptoms of atopic dermatitis.The goal of this study is to determine the effect of     Staphefekt on the use of topical corticosteroids in patients with atopic dermatitis.     Secondary goals are to retrieve information about the effect on clinical symptoms, quality of     life, growth characteristics of Staphylococcus aureus and the further microbiome.   "
34028|NCT02840370|"     The purpose of this study is to investigate whether transcranial direct current stimulation     (tDCS) of the prefrontal cortex (PFC) influences lexical access and language production. The     experimental paradigm will assess the impact of prefrontal stimulation by tDCS versus sham     tDCS (S-tDCS) over the PFC of patients with chronic post-stroke aphasia during three language     production tasks and a nonverbal executive functions task.   "
34029|NCT02840357|"     The main purpose of this study is to determine the effect of consumption of purple wheat     anthocyanin-rich products for eight weeks by human participants with an elevated level of     chronic inflammation, on oxidative stress and inflammatory responses as measured by select     plasma biomarkers.   "
33985|NCT02840942|"     Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized children.     The placement of IVs requires significant staff time, contributes to health care costs, and     causes pain and distress in the patients receiving them. Techniques currently used at     Children's Hospital Los Angeles (CHLA) to reduce children's anxiety and increase success of     IV placement center depends on members of the Child Life Department distracting patients     during insertion. Recent literature has suggested that humanoid robots can be a powerful form     of distraction and lead to decreased pain during painful procedures in children. Work done by     the University of Southern California (USC) Interaction Lab has shown that socially assistive     robots can use techniques more complex than pure distraction to lead to a human-robot     interaction that is perceived as more positive by the human. The investigators propose a     project pairing children receiving an IV with either a (1) Child Life staff member only (2)     pure distraction robot + Child Life or (3) an robot teaching coping skills + Child Life with     a goal of reduced pain. Pain will be measured by participant self-report, family member     perceived pain, parasympathetic activation, and pain behaviors as measured by video.   "
33986|NCT02840929|"     OBJECTIVES: Up to 15% of patients with peptic ulcer bleeding will develop rebleeding, mainly     in those with ulcers of higher-risk stigmata (i.e. Forrest class Ia to IIb). Randomized     trials show that second-look endoscopy is effective in reducing rebleeding rate. However,     whether to withhold aspirin or other anti-platelet agents (for the treatment of established     cardiovascular or cerebrovascular diseases) remains controversial. Studies have shown that     although continuation of anti-platelet agents reduces mortality rate due to reduced     cardiovascular and cerebrovascular events, there is a marginal increase in rebleeding risk.      HYPOTHESIS: We hypothesize that continuation of aspirin or other anti-platelet agents coupled     with second-look endoscopy could reduce the rebleeding rate without increasing the risk of     thromboembolic events in high-risk patients.   "
33996|NCT02840786|"     This is a randomized study comparing stent and plaque excision systems in treatment of     Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal     artery)   "
33987|NCT02840916|"     Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention.      Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided     into laser acupuncture and control group. A single-blind clinical trial will be conducted and     the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After     about 3 weeks of treatment, the differences of the subjects' body weight, body mass index,     and waist circumference will be analyzed with ANOVA between laser acupuncture and control     group.   "
33988|NCT02840903|"     The objective of this study is to evaluate the image quality for different iodine delivery     rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced     Multi-Detector Computed Tomography (MDCT) considering the body weight of patients.   "
33989|NCT02840890|"     Adjuvant chemotherapy with the protocol 3 cure of 5-FU + Epirubicine + Cyclophosphamide     (FEC100) and 3 cure of Taxotere is a standard treatment in the management of patients with     breast cancer and in adjuvant situation.      The efficacy of 3 FEC100 and 3 Taxotere protocol in adjuvant situation for women treated for     breast cancer is associated with several invalidating side effects for the quality of life of     patients. 92% of women treated will present gastrointestinal toxicities of any grade. 11%     will present nausea and vomiting of grade 3-4. Current treatments to prevent these     gastrointestinal toxicities include Emend from Day 1 to Day 3 in association with setrons at     Day 1 and corticosteroids from Day 1 to Day 3. Despite the marked improvement in     gastrointestinal toxicities with preventive treatments, 83% of patients would use     alternatives medicine: homeopathy, herbal medicine, acupuncture, hypnotherapy and / or     osteopathy.      Osteopathy is a method of care and unconventional therapeutic approach. In France, the     professional title of osteopath is recognized. It aims to prevent and treat functional     disorders, especially those related to adverse effects of treatment. In oncology, this     discipline may have additional support for the patient by limiting the mechanical and     physical constraints of sensitive areas to the toxicity of the treatment. In the case of     gastrointestinal toxicities of myofascial and musculoskeletal techniques are used in     abdominal areas to relieve symptoms. The investigators hypothesis is that osteopathy could     have an interest in the management of gastrointestinal toxicities related to chemotherapy in     women with breast cancer and in adjuvant treatment situation.   "
33990|NCT02840877|"     After HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an     infectious disease globally. Retrospective studies from many countries, including the United     States and South Africa, have consistently reported that in addition to having a higher     burden of TB disease, patients with problem alcohol use have worse TB treatment outcomes.     This prospective study will attempt to clarify both behavioral and biologic causal mechanisms     underlying the deleterious effects of problem alcohol use on TB treatment response.   "
33991|NCT02840864|"     Aim of the study is to test whether surgical removal of a tumor under sonographic control as     compared to conventional method reduces the rate of resections and local relapse   "
33992|NCT02840851|"     Baseline cerebral blood flow through the middle cerebral artery (MCA) and cerebral     vasodilator response of the MCA to inhaled carbon dioxide (CO2) will be measured in young     women, young men, older women, and older men using Magnetic Resonance (MR) imaging and     transcranial Doppler ultrasound (TCD). Data collection techniques will be compared.   "
34008|NCT02840630|"     The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers     controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the     non-diabetic group while the diabetic volunteers will be randomised to a diabetic control     intervention group or a diabetic fish intervention group. Baseline data will be collected     from all three groups but only diabetic control intervention group and diabetic fish     intervention group will go through the 16-week study. This will allow the investigators to     compare the metabolic health across South Asian population in people with and without     diabetes.      The recommended intake of EPA and DHA daily is ~450 mg per day for cardiovascular health, or     approximately 3 g per week. Over the course of 16 weeks, subjects in the diabetic control     intervention group will continue with their habitual diet, while subjects in the diabetic     fish intervention group will receive two 125 g portion of tinned mackerel (containing 7.8 g     n-3 LCPUFA26) every week, to replace a portion of red meat or poultry. Previous n-3 LCPUFA     intervention study among South Asian people in the United Kingdom was able to reverse lipid     abnormalities with supplementation of 2.5 g of EPA and DHA per day for 12 weeks. However, the     same study also shows that their daily consumption of EPA and DHA is only 68±99 and 112±171     mg respectively. Therefore, only 1.1 g n-3 LCPUFA per day is given in this study to increase     compliance.      Recipe recommendations using mackerel will be provided. Non-diabetic volunteers will be     recruited only to obtain baseline data in order to compare their metabolic profile with that     of the diabetic volunteers. This will allow us to investigate the link between omega 3 status     and glycaemic control in a South Asian population.      Fish is chosen as an intervention as opposed to EPA and DHA supplements in order to capture     the benefits of eating fish as an important source of not only n-3 LCPUFA, but also other key     nutrients such as vitamin D, selenium and iodine.   "
33993|NCT02840825|"     Human cytomegalovirus (HCMV) is the leading cause of neonatal viral infection and can have a     significant impact on the neurosensory development of newborns and especially preterm     infants. HCMV infection may result from maternal-fetal transmission during pregnancy or     postnatal transmission. While congenital HCMV infection affects about 2-5% of very preterm     infants, the risk of postnatal infection, particularly through breast milk, is much higher in     this population (prevalence of about 20%). Many learned societies wonder about the interest     to inactivate HCMV (by freezing or pasteurization) in breast milk in order to reduce or     eliminate contamination of these children. However, freezing is relatively inefficient to     reduce contamination and pasteurization drastically alters the nutritional quality of the     milk. Therefore, a systematic preventive treatment of breast milk for very preterm infants is     not currently recommended. An alternative approach could consist in detecting HCMV in breast     milk to target at-risk situations. This detection can be performed by PCR but its cost and     the time required to obtain the result prohibits its use for a mass detection. Currently,     viral status of breast milk is not explored in practice and, depending on the health centers,     breastfeeding is continued as such or milk is systematically inactivated.The main objective     of VIRUMILK is to study the feasibility of the CMV detection in breast milk from lactating     mothers with a biochip.The ultimate goal is to prevent postnatal HCMV infection of preterm     newborns less than 33 weeks.   "
33994|NCT02840812|"     This is a single center, open-label, non-randomized, 1:1 parallel control and single dose     administration study design. Healthy subjects will be matched to severe renal function     impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as     parallel control, which matches healthy with normal renal function according to the of     subjects with impaired renal function as, after enrollment of subjects with severe impaired     renal function (eGFR≤30mL/min/1.73m2，CKD-EPI estimated). Renal function impaired group and     control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect     the blood and urine samples before and after the administration to perform pharmacokinetic     analysis and safety observation.   "
33999|NCT02840747|"     This document is a protocol for a non-interventional human research study in which the     investigator hopes to better understand the changes that take place in T cells in Cutaneous     T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the     collection and storage of tissue samples from patients with CTCL for future research studies.     Collection and storage of tissue samples from control patients will also be carried out.   "
34000|NCT02840734|"     This study investigated the immediate effects of Kinesio taping on muscular power, strength,     endurance, and lower limb fatigue when taping is applied to rectus femoris and around the     patella of obese adults based on Kinesio taping techniques.   "
34001|NCT02840721|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of     PF-06480605 in subjects with moderate to severe ulcerative colitis.   "
34002|NCT02840708|"     Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose     inhalation.      Study Design: Pharmacokinetic open study   "
34003|NCT02840695|"     Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial     skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During     the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been     successfully introduced to reduce the disease activity. It is unclear whether bDMARD     treatment had an effect on spinal fracture risk related to AS. This national registry study     will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort     of patients with AS.   "
34004|NCT02840682|"     The primary objective of this study is to describe mortality of newborns who received basic,     advanced or no neonatal resuscitation immediately after birth at Shoklo Malaria Research     Unit.   "
34005|NCT02840669|"     Friedreich's ataxia (FA) is an autosomal recessive disease with an incidence of 1/50,000 in     the Caucasian population. The main manifestations of FA are progressive sensory and     cerebellar ataxia and cardiomyopathy (CM). It is the most common form of inherited ataxia. A     severe CM affects ~60% of FA patients, mostly young adults, and leads to cardiac failure then     death. Currently, no therapy can change the course of this severe cardiomyopathy.      This study is designed to characterize the cardiac manifestations of FA using cardiac     magnetic resonance (CMR), echocardiography, serum cardiac biomarkers and evaluation of     fatigue severity, in the context of the neurological disease.   "
34006|NCT02840656|"     In this prospective observational study we aim to determine the prevalence of oropharyngeal     and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility     to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to     determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic     characteristics of oropharyngeal and rectal of predominant GNB colonization.   "
34007|NCT02840643|"     To examine efficacy of combined unimanual and bimanual intensive therapy in children with     unilateral brain injury. A key question in hemiplegia therapy is whether the affected hand     should be trained alone or in tandem with the other hand. In constraint-induced movement     therapy (CIMT), a participant's less-affected upper extremity is restricted with a sling,     cast, or mitt, while the participant actively uses the affected arm and hand in skill-based     therapeutic activities. Bimanual therapy, in contrast, engages both hands in therapeutic     movement. Since constraint and bimanual therapy target different aspects of hand use, they     could have synergistic effects on hand function when given in combination.   "
34010|NCT02840604|"     The management of cancers and their therapeutic guidance was until shortly mostly based on     histopathological considerations of the tumor. the development of targeted therapies is a     turning point and keeps increase. These molecules target a specific molecular defect in the     tumor making it more effective and more specific treatment. But these treatments are only     effective if the tumor has a specific molecular abnormality that is characterized and known.      These therapeutic progresses have been made possible through the decoding of the human genome     and the molecular defects occurring during the carcinogenesis process. Now, dozens of     therapies targeting a specific molecular abnormality are available in the therapeutic arsenal     and dozens more are under development in clinical trials Phase 1 to 3.      In recent years, the democratization of next generation sequencing has opened a new era in     cancer research but also for molecular diagnostics. Indeed, the enormous sequencing     capabilities offered by high-throughput sequencing technologies allow analysis in a limited     time the entire coding sequence of the genome (exome), or even the entire genome of a tumor     (whole genome sequencing). Thus, the evolution and the development of broadband and     associated bioinformatics tools for genomics techniques now make it possible to establish the     genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to     propose and specifically targeted direct therapeutic identified genetic alterations and     supposedly responsible for tumor development. An analysis of tumor exome by next-generation     sequencing (NGS) and provides information on genetic modifications of these tumors.      This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this     study is to evaluate the clinical benefit of an analysis of exome performed in current     practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by     quantifying the number of patients undergoing therapeutic proposal based on the results of     the analysis of the profile of the tumor.   "
34011|NCT02840591|"     Primary aim of this study is to assess the feasibility of conducting clinical research for     delirium (confusion due to medical problems) at Clements University Hospital in Dallas,     Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or     an over-the-counter supplement called Citicoline are safe and beneficial in delirium.   "
34012|NCT02840578|"     Objectives: To examine whether NK cell activity associates with two confirmed risk factors:     (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for     potential confounders, including age, gender, body mass index (BMI), personal history of any     cancer, and family history of cancer. This project is aimed at measuring NK cell activity,     which may eventually help in reducing false positive rates of LDCT screening, improve early     detection of lung cancer, and assist in risk assessment in patients with lung cancer. The     investigators hypothesize that measurement of NK cell activity may be a useful tool for     assessing changes in immunosurveillance in patients with conditions or diseases where NK cell     activity has been shown to be reduced, such as lung cancer   "
34013|NCT02840565|"     The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple     rising dose regimens of BIA 5-453.   "
34014|NCT02840552|"     The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to     establish our ability to reproduce results from the literature using FCH-PET/CT as a     diagnostic and decision making tool in the management in two predefined groups of prostate     cancer patients, specifically, biochemical recurrence and high risk staging. The primary     endpoints of the study are the incidence of adverse events (AE) in the study population up to     24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a     per-patient and per-lesion basis.   "
34016|NCT02840526|"     Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative     pain management after open renal resection surgery.      Design, setting, participants: It was a prospective, randomised, open label study held in a     university hospital between 08.2013-12.2014. 58 Patients enrolled in the study were scheduled     for elective open renal surgery (open nephrectomy or open nephron-sparing surgery) and     randomised into two groups - group PVB (n=27) and group GEN (n=31).      Interventions: PVB group received preoperative ThPVB with 0,5% bupivacaine followed by     general anaesthesia. GEN group received standard general anaesthesia. Both groups were     treated postoperatively with oxycodone IV PCA (patient controlled analgesia) combined with     non-opioid analgesics as rescue drugs. The investigators recorded pain severity in VAS,     oxycodone requirement in time points, total oxycodone requirement, and sedation levels     throughout the first 48h. The investigators measured opioid related adverse events 24 and 48     h postoperatively and patients satisfaction 48h postoperatively.   "
34017|NCT02840513|"     This randomized controlled trial is going to evaluate whether an intervention consisting of a     smartphone application to assist smokers living with HIV to quit in combination with CO     self-monitoring compared to stop smoking counselling by physicians during usual care results     in higher self-reported and biochemically verified smoking cessation rates at 6 months.   "
34018|NCT02840500|"     Patients treated in Palliative Care Units are potentially fragile patients, especially in our     case, which are cancer patients. The management of these patients is usually done from     experience, because these patients rarely meet criteria for clinical trials, as their     inclusion could affect results obtained in the trial.      There is insufficient clinical information on the quality of life of cancer patients with     breakthrough pain treated in palliative care units according to routine clinical practice.     For this reason we consider it is appropriate to prospectively evaluate the quality of life     of cancer patients with cancer breakthrough pain treated in palliative care units as well as     the characteristics of these patients.      This post-authorization observational study will assess the quality of life of patients with     breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.   "
34030|NCT02840344|"     This study aims to improve relationship, psychological, and physical adjustment among young     breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life     partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet     the specific needs for young breast cancer survivors and their partners. The intervention     will be administered in your home by using recorded videos of a trained MBSR instructor.     Before, during, and after the 8-week intervention, participants will be asked to complete     surveys.   "
34031|NCT02840331|"     The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size,     number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with     regard to the detection of peritoneal metastases of locally advanced gastric cancer at 50     adult patients.   "
34042|NCT02840188|"     The aim of this project is to evaluate retrospectively goalkeeper's fractures in children     using the children fracture classification and to evaluate the distal radius tilt angle of     the growth plate on plain radiographs of the forearm.      Patients positive for goalkeeper's fracture will prospectively answer a questionnaire     concerning risk factors and circumstances during the injury.   "
34019|NCT02840487|"     Background:      The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash,     joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were     reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve     weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with     Zika virus infection. There is currently no cure for or vaccine against the infection.     VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika     virus protein. The body may use this to build an immune response.      Objective:      To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.      Eligibility:      Healthy people ages 18 35      Design:      Participants will be screened through a separate protocol with:        -  Medical history        -  Physical exam        -  Lab and urine tests      Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic     visits over 2 years. Most will occur in the first year, with long-term follow-up visits at     months 18 and 24. Visits include a physical exam and blood and urine tests.      Participants will have vaccine injections. A high-pressure device pushes the vaccine through     the skin and into the muscle of the upper arm. They will have 2-3 injections depending on     their group.      Vaccine visits last 4-6 hours. Others last 1-2 hours.      Participants will keep a diary for 7 days after each injection. They will record their     temperature and measure any skin changes at the injection site each day.      Participants might have extra visits and blood tests if they have health changes.   "
34020|NCT02840474|"     Background:      The human body uses antibodies as one way to help fight infection. VRC01LS is an antibody     directed against the HIV virus. Researchers want to see if it is safe and well tolerated.     They will study the amount of VRC01LS in the body and how it changes over time. They will     check to see if people who get VRC01LS develop an immune response to it.      Objective:      To see if VRC01LS is safe and well tolerated.      Eligibility:      Adults ages 18 70 who are HIV infected but otherwise healthy. Females who are able to get     pregnant must be willing to use birth control during the study.      Design:      Participants will be screened in another protocol.      Participants will get the study drug one time, by IV infusion. A needle will guide a thin     tube into a vein. The study drug mixed with salt water will be dripped into the vein over     about 30 minutes.      Participants will be monitored for 30 minutes after the infusion.      Blood samples will be taken at the following times:      Once before the infusion      5 times in the 4 hours after the infusion      1 time 24 hours after infusion. Some participants may have 3 optional blood draws in the time     period between 4 and 24 hours.      For 3 days after the infusion, participants will write their temperature and symptoms in a     diary.      There will be a total of 23 study visits over 48 weeks. Ten visits will be in the first 4     weeks. At all visits, participants will answer health questions and give blood samples.   "
34021|NCT02840461|"     A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study     to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis     Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of     moderate to severe papulopustular rosacea.   "
34022|NCT02840448|"     Background:      People with Williams Syndrome (WS) and supravalvular aortic stenosis (SVAS) have less     elasticity in their blood vessels. This is called blood vessel stiffness. Blood vessels may     have focal narrowings called stenoses or may just be globally more narrow.      Objectives:      Researchers want to see how blood vessel differences in people with Williams Syndrome and     supravalvular aortic stenosis affect organs in the body including the heart, gut, kidneys,     and brain.      Eligibility:      People ages 5-85 who have WS or SVAS      Healthy volunteers ages 5-85      Design:        -  Participants will have yearly visits for up to 10 years. All participants will be          offered the same tests.        -  Participants will give consent for the study team to review their medical records. If          the participant is a child or an adult with WS, a parent or guardian will give the          consent.        -  Participants will visit the NIH where they will have a physical exam and medical          history. Based on their health history, participants will undergo a series of imaging          tests and measures of blood vessel function over the course of 2-4 days. Tests of          cognitive abilites will also be performed. Blood will be drawn and an IV may be placed          for specific tests.   "
34023|NCT02840435|"     This study is designed to test the effectiveness of the smoking cessation intervention Sit     to Quit through a randomized-control trial. This study will compare abstinence outcomes in     the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit     Line.   "
34024|NCT02840422|"     The reduction of functional limits and disablilities induced by knee osteoarthritis as well     as improvement of patients quality of life is a public health need registered amongst the     priorities established by the French law of August 9th 2004 relative to Public Health policy.     However, the response to this need is not limited to treatment with health products.      This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of     life treated by intraarticular injections, eventually for several years, by difference of     usual clinical trials.      This open, prospective, multicentric study aims to analyse, in patient care, the impact of     three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months     (D180) in the symptomatic treatment of knee osteoarthritis.   "
34025|NCT02840409|"     This is an open-label, randomized, multi-center, comparator Phase II trial looking at the     addition of Bevacizumab to Vinblastine in chemotherapy naïve pediatric patients with     progressive Low Grade Glioma aged 6 months to less than18 years of age at the time of     initiation of therapy. Participants will be randomized to Arm A or Arm B. Arm A includes 68     weeks of single agent Vinblastine administered once weekly IV. Arm B includes 68 weeks of     Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered     every two weeks IV for the initial 24 weeks. Randomization will take place at the time of     registration taking into account NF1 and BRAF-KIAA1549-fusion status.   "
34026|NCT02840396|"     The purpose of this study is to investigate the effects of repetitive transcranial magnetic     stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production.   "
34027|NCT02840383|"     Assess the effects of a school-based multi-component intervention on school connectedness,     school engagement, and developmental assets through a group randomized, participatory trial.   "
34032|NCT02840318|"     The investigators developed the theory-driven 'Compassion Intervention', an integrated,     interdisciplinary approach to address existing gaps in end-of-life care for people with     advanced dementia. The Intervention consists of two core components: facilitation of an     integrated, multi-disciplinary approach to assessment, treatment and care; and education,     training and support for formal and informal carers. The intervention is implemented by an     Interdisciplinary Care Leader. The primary aim is to understand how the Intervention operates     in two care homes (with nursing support) in two different health and social care economies;     one in the Camden Commissioning Group and one in the Barnet Commissioning Group, both in     London, UK. The secondary aim is to collect preliminary outcome data and estimate the cost of     employing an Interdisciplinary Care Leader to inform further evaluative studies. The final     aim is to check that the Intervention causes no harm to residents and their family carers.   "
34033|NCT02840305|"     Using the available data from psychophysics, cellular electrophysiology and functionnal     neuroanatomy of visual pathway, current models of visual recognition suppose that the     perception of scenes start with a parallel extraction of differents elementary visual     characteristics to different spatial frequencies according to a default processing principle     named : 'coarse-to-fine'.      According to this principle, the visual scene's analysis would be decomposed in two steps.     Fisrt, the fast analysis of the global information borne by low frequency of the scene will     provide an overview of the scene's structure and would enable a first perceptive     categorisation which would be then refined, approved or denied by the latest analysis of the     most local, detailed and precise information, carried by the very high spatial frequency of     the scene.      The research carried out since several years is preparing a biologically plausible model and     to find brain bases by different imaging techniques among healthy subjects but also patients     with a brain lesion and patients with a peripheral lesion.      The main goal of this Magnetic Resonance Imaging study is to find brain bases of natural     scenes's visual perception of the natural scenes.      Three studies in Magnetic Resonance Imaging will be conducted, during which subjects will     have to categorize pictures of natural scenes filtered in spatial frequencies. The outcome of     this study will allow to refine models of visual recognition, most of them based on analysis     of spatial frequencies.   "
34034|NCT02840292|"     The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late     preterm neonates' was done with an objective to determine whether low maternal hemoglobin     (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age)     correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm     Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be undertaken     to improve their long term outcomes and to generate useful data on a previously well     recognised but under researched entity.   "
34035|NCT02840279|"     This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled,     multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic     profile of BPN14770 in healthy young and elderly male and female subjects and to provide a     preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects.   "
34037|NCT02840253|"     Investigators have started an awake spinal anesthesia program in conjunction with pediatric     surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of     general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a     lack of significant hemodynamic changes in neonates and infants following spinal anesthesia;     however, there are limited data regarding its impact on tissue oxygenation. The goal of the     current study is to assess changes in tissue and cerebral oxygenation using non-invasive near     infrared spectroscopy following spinal anesthesia.   "
34038|NCT02840240|"     Opioids are effective analgesics, but cause side effects including sedation, respiratory     depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a     FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless     leg syndrome, may decrease your need for narcotics and thus decrease the risk of side     effects. The investigator hopes this study will determine if gabapentin enacarbil decreases     opioid consumption and pain after surgery.      Patients having elective hip and knee surgery will be asked to participate in the study.     Patients will be randomized to Gabapentin enacarbil 600mg twice per day for 5 days or Placebo     twice per day for 5 days.      One day prior to surgery the patient will take Gabapentin enacarbil 600mg or placebo 600mg     twice a day with meals. On the day of surgery, the patient will take Gabapentin enacarbil     600mg or placebo 600mg two hours before the surgical procedure. Six hours after the     completion of surgery, the patient will receive Gabapentin enacarbil 600mg or placebo 600mg.     If the patient is sent home, the patient will be given 6 Gabapentin enacarbil 600mg or     placebo 600mg pills to take home along with instructions. However, if the patient remains     hospitalized, on the first day after the surgery, the patient will have pain assessed in the     morning using a numerical rating score. The patient's quality of recovery will be evaluated     using a questionnaire and the patient will receive Gabapentin enacarbil 600mg or placebo     600mg twice a day with meals. The second and third day the patient is in the hospital, the     patient will have pain assessed in the morning using a numerical rating score and the patient     will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. Then, three     months after surgery, the patient will receive a phone call to follow-up with possible pain     or discomfort the patient may be feeling.   "
34039|NCT02840227|"     The primary hypothesis is that disease-free survival is improved in patients undergoing     resection for tumor thought to be stage I-III primary non-small cell lung cancer in patients     with combined general-epidural anesthesia & analgesia as compared to patients receiving     general anesthesia and postoperative patient-controlled opioid analgesia. Patients having     surgery for resection of potentially curable lung cancer will be randomized to combined     general and epidural anesthesia or general anesthesia with opioid analgesia. The primary     outcome will be disease-free survival.   "
34040|NCT02840214|"     This research project is focusing on changes in mental fatigue due to transcranial direct     current stimulation (tDCS) in healthy individuals. The study aim is to see if mental fatigue     can be rescued by administering a safe dose of tDCS. tDCS has been shown to decrease fatigue     in healthy individuals experiencing extended wakefulness, and the investigators aim to     investigate if similar results can be found in a fatigue inducing task. This is a     single-blind randomized control trial that will compare mental fatigue between tDCS treatment     and sham treatment groups through both subjective and objective measures. Objective fatigue     will be measured by reaction time with the Stroop test and subjective fatigue will be     measured by the multidimensional fatigue inventory questionnaire.   "
34041|NCT02840201|"     This is a sub-study of the ARTESiA study registered as NCT01938248. This study is designed to     validate biomarkers in subclinical atrial fibrillation and to determine if the prospective     biomarker will be informative of the potential efficacy of treatment.   "
34043|NCT02840175|"     As biologic treatments are expensive and associated with some concerns regarding long-term     safety, investigator hypothesize that early tapering and then withdrawal of biological agent,     in an homogenous group of children with juvenile idiopathic arthritis achieving inactive     disease, is safe and not inferior to the maintenance of stable treatment intensity over 24     weeks. In addition, investigator also hypothesize that an earlier tapering of treatment is     associated with a better quality-of-life and a general cost saving effect. MRP8/14 will be     studied as a potential biomarker for the risk of relapse. A study for biologic agent,     anti-biologic agent antibodies and a pharmacogenomic approach will complete the research, as     pharmacokinetic study during withdrawal of biologic treatment are rare in children.   "
34044|NCT02840162|"     This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2)     inhibition suggested by preclinical systems occur in human prostate cancer. To answer this     question, men who have chosen prostatectomy will be randomly assigned to preoperative     treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant,     and benign prostate tissue will then be examined for apoptosis, androgen receptor and     prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment     effects. The data generated by this study will serve as a foundation for the development of     COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger     scale clinical trials aimed at treatment and prevention of prostate cancer, and will validate     current preclinical models used to study COX-2 in prostate cancer.   "
34045|NCT02840149|"     Positron emission tomography/computed tomography (PET/CT) is an advanced nuclear medicine     scan. This technology allows precise and early cancer to be visualized and measured on whole     body images. Patients with Neuro-Endocrine tumors (NETs), require specialized molecular     imaging to stage, re-stage and assess eligibility and response to therapy. 68Ga-DOTATATE is a     nuclear medicine imaging agent that is not yet approved by Health Canada but used extensively     throughout the world. The Ki-67 index, a marker of cell proliferation in NETs, is one of the     most important prognostic factors in this disease. The objective of this study is to evaluate     if the maximal standard uptake value (SUVmax) on PET/CT in NETs inversely correlates with     Ki-67 score on initial biopsy. If this hypothesized correlation between SUV and Ki-67 score     is reproduced, then DOTATATE would serve as a non-invasive method to assess cellular     proliferation and therefore prognosis of these patients.   "
34046|NCT02840136|"     In this trial, various factors that may influence the antibiotic concentrations measured in     the sputum of cystic fibrosis patients are studied.      A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as     hypertonic saline, dilution of the antibiotics in sputum can be expected. The extent of this     dilution is unknown and will be determined by comparing sputum samples collected before and     after the use of an aerosol.      A second factor is the homogeneity of the antibiotics within one sputum sample. Multiple     aliquots of the same sputum sample will be compared.      A third factor is the variability between several sputum samples collected during a drainage     session. The antibiotic concentrations in 3 separate sputum samples will be compared.      The final goal is to standardise the sputum sample collection and processing of the samples     to ensure a accurate concentration measurements in sputum.   "
37859|NCT02790086|"     The primary objectives of the study are        -  to perform a survey on the clinical management of unintentional hypothermia during          surgery in France.        -  to assess the impact of perioperative hypothermia on anemia and myocardial injury.   "
34047|NCT02840123|"     The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG)     treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines      Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal     Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated     in peripheral blood and CSF Assess overall survival and progression free survival Correlate     the neuroradiological changes with the clinical course and immune response generated in     peripheral blood and CSF Quality of life evaluation   "
34048|NCT02840110|"     Subjects treated with ACTR087 may participate in this long-term follow-up study after the     completion of the final scheduled visit in the parent clinical study or other investigational     setting, such as compassionate use, named patient IND, expanded access program, or equivalent     setting. No investigational product or treatment will be administered in this study. These     subjects will be followed for safety monitoring on a schedule of decreasing frequency through     15 years post-ACTR087 treatment, in accordance with US FDA Regulatory guidance pertaining to     long-term safety follow-up for study subjects receiving recombinant DNA-containing     investigational products.   "
34049|NCT02840097|"     Trauma is the leading cause of death and disability in children in the United States. The     long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA;     a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to     evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.   "
34050|NCT02840084|"     Purpose: The purpose of this investigation is to test the safety and effectiveness of the     Aspen System™ and Aspen Rehabilitation Technique. The device is intended for the therapeutic     treatment of capsular contracture of the breast in conjunction with the Aspen Rehabilitation     Technique. The hypothesis of the proposed study is that external ultrasound with the Aspen     System™ device in conjunction with the Aspen Rehabilitation Technique is safe and effective     in the reduction by at least one level of Baker Grade III capsular contracture in cosmetic     breast augmentation patients, maintained at one year from the final treatment. Potential     benefits of the study to subjects include improvement in the grade of capsular contracture of     the breast without surgical treatment. The investigation is planned to last 12 months.   "
34061|NCT02839941|"     The objective of the study is to evaluate the effect of iguratimod concomitant with     conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly     mismatched Kidney Transplant recipients.   "
34062|NCT02839928|"     Nasal Ketamine has previously been tested in children for deep sedation or preoperative     anxiolysis. The investigators intend to test the efficacy of low dose nasal Ketamine in     children undergoing minor procedures in the emergency department.   "
34090|NCT02839564|"     Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial and long term     effects are not known. The objective was to to evaluate long term effects of laparoscopic     adhesiolysis for treating chronic abdominal pain.      Therefore one hundred patients with abdominal pain attributed to adhesions were randomized to     laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed     after 3, 6 and 12 months and 12-year follow-up.   "
34051|NCT02840071|"     Title: Acceptance and Commitment therapy for Individuals with Head and Neck Cancer     Experiencing Psychological Distress.      Head and neck cancer (HNC) patients are particularly vulnerable to experiencing psychological     distress . The current guidelines from the National Institute of Health and Care Excellence     are that cognitive-behavioural therapy (CBT) is to be offered to adults with a long-term     physical health condition experiencing anxiety and depression. CBT has been shown to have     several inadequacies for individuals with physical health conditions such as cancer.     Acceptance and commitment therapy (ACT) takes an alternative approach to CBT, aiming to     change a person's interaction with their thoughts rather than suppress or alter thought     content. Although studies indicate encouraging findings for the effectiveness of ACT for     individuals with breast cancer; the HNC- transfer-ability of findings is yet untested, and     there is a need to evaluate the replicability of ACT effects in people living with HNC, given     the unique challenges inherent to the disease and its treatment.      This study aims to inform clinical practise by using a hermeneutic single-case efficacy     design (HSCED) to answer the following questions:        1. Is there evidence of psychological change after the introduction of the ACT          intervention?        2. If present, are the changes attributable to (a) ACT components, (b) common factors,          and/or (c) non-therapeutic factors?      The study will involve recruiting three adults with HNC from specialist HNC psychology     services. Each participant will have six individual sessions of ACT and complete various     process and outcome questionnaires during sessions. Following the intervention, participants     will have a semi-structured interview where their views of the therapy and any changes made     will be explored. Two outcome measures will be posted to participants at 1-month and 3-month     post intervention.   "
34052|NCT02840058|"     Recent scientific advances have shown the important role of immune system against cancer.     Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment     and generate durable clinical responses in some patients. The development of tools for     monitoring anti-tumor immune responses dynamically is a major challenge to predict the     effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.      Thus, the objective of our study is to analyse the interest of the monitoring of     anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using     an immunoassay developed by our group.   "
34053|NCT02840045|"     The purpose of this study is to use a new method to differentiate mnesic abilities of early     alzheimer patients and patients with a depressive disorder.      This method is based on the recording of cerebral activity while patients listen to familiar,     unfamiliar and newly-learned music.   "
34054|NCT02840032|"     Bedside ultrasonography for detection of pneumothorax after transbronchial lung biopsies in     lung transplant patients   "
34055|NCT02840019|"     The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing     MRI coils specifically for pregnant women and testing recently developed MRI image     acquisition techniques. The investigators aim to more reliably obtain higher quality fetal     MRI images when compared to current clinical fetal MRI.   "
34068|NCT02839850|"     The primary objective of this study is to examine the change from pre-operative baseline to     two year postoperative functional performance improvement for the ATTUNE primary, cementless     TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be     carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless     CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).   "
34292|NCT02836938|"     It's the aim of this study to clarify, whether the non-invasive assessment of breath can     serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS     can be discriminated by the level of certain VOCs than there would also be a potential to     actually predict the development at an early stage and would enable an earlier intervention.   "
34056|NCT02840006|"     CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide a     number of conditions that exceed the limits of cardiovascular stability, myocardial     protection and other organs. Moreover, the combination of general anesthesia and spinal     anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The     goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative     in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal     anesthesia associated with general anesthesia.      METHODS: Clinical, prospective, randomized and double covered study, approved by the Research     Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing the Terms of     consent, were randomized and divided into two groups: GI - General and GII - General +     subarachnoid. General anesthesia was induced according to the weight of each patient and     maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20 mg of 0.5%     hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in cephalo-position     slope of 45 degrees for 10 minutes in Group II. In the statistical study was performed using     the Mann-Whitney test; the level of statistical significance was set at 5%.   "
34057|NCT02839993|"     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual     associative memory leads to a performance improvement in healthy older individuals.   "
34058|NCT02839980|"     In this prospective observational multicenter study we aim to determine the prevalence of     oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized     subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in     surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery)     and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of     such colonization in a 10-day timeframe; determine the phylogentic characteristics of E. coli     isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli     isolates; to compare the phylogentic characteristics of colonization and potential E. coli     infection isolates; to compare the rectal and oropharyngeal colonization composition;     description of oropharyngeal microbiote   "
34059|NCT02839967|"     According to the International Association for the Study of Pain (IASP), the     temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of     orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular     joints. Pain is considered one of the most common and limiting clinical manifestations. One     of the most used resources to treat muscle pain is the low-level laser therapy (LLLT),     However, the mechanisms responsible for the effects observed in clinical trials remain poorly     elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some     advantages, among them the larger area radiation point and low cost. However, its effects     remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid     muscle. Assuming that there is need to investigate therapeutic resources that combine not     only different wavelengths as well as different light sources (LED and LLLT), this study aims     to evaluate the effect of phototherapy with a combination of different light sources on pain,     joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It     will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals     participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly     and stratified by the method of sealed envelopes. The results will be evaluated using:     RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in     a 6 sessions and will be evaluated in four different moments. The analyses of the data will     be performed by adopting a significance level of 5%.   "
34060|NCT02839954|"     The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell     immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.   "
34063|NCT02839915|"     The purpose of this study is to determine the effectiveness of folinic acid in the treatment     of language problems in children with autism spectrum disorder. Folinic acid, also known as     leucovorin, is approved by the U.S. Food and Drug Administration (FDA) to decrease side     effects during cancer chemotherapy. Folinic acid may be helpful in treating language problems     in children with autism spectrum disorder, but this is not known. Therefore, folinic acid is     an investigational new drug for this study.Investigators will enroll up to 60 participants in     this study at the Marcus Autism Center over 5 years and a total of 160 participants across     all three centers. Participation will last between 12 - 24 weeks   "
34064|NCT02839902|"     The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid     ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients     receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group     of patients not treated with omega-3-acid ethyl esters.   "
34065|NCT02839889|"     The purpose of this study is to determine if naloxegol can be used in the treatment of     opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of     a two week randomized double blind period followed by a two week open-label period.   "
34066|NCT02839876|"     The purpose of this study is to determine if intravenous acetaminophen is superior to oral     acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.   "
34067|NCT02839863|"     Due to better treatment options and earlier detection, survival rates of patients with breast     cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life     and the cosmetic outcome are becoming more important. Also, many competing experimental     interventions (e.g. treatment, lifestyle interventions) for breast cancer are being     developed, all in need to be properly evaluated before being implemented in routine clinical     care. Randomized Controlled Trials are the gold standard to do so, but they have shown many     challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized     Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized     evaluations of experimental interventions, with potential for increased recruitment,     comparability and long-term outcomes as a standard.      By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the     investigators aim to:        -  provide an infrastructure for efficient, fast and pragmatic evaluation and          implementation of experimental interventions        -  gain insight into short and long-term treatment response, toxicity, complications,          quality of life and survival of patients with breast cancer.   "
34069|NCT02839837|"     Depression is associated with a disruption in the mechanisms that regulate neuroplasticity.     Effective treatment and rehabilitation of depression, and other neurological and     neuropsychiatric disorders, relies on neuroplasticity. Thus, identifying therapies that     enhance neuroplasticity (neuroplastic adaptation) are vital in the comprehensive treatment of     depression. Aerobic exercise training has been demonstrated to have antidepressant properties     and single bouts of aerobic exercise may provide short-term improvements in affective states     in depression. Furthermore, acute aerobic exercise may enhance the response to known     neuroplasticity-inducing paradigms. However, it is unclear if aerobic exercise can influence     neuroplasticity in depression and the neurobiological mechanisms underlying acute     neuroplastic changes are not well understood in depressed and healthy cohorts. Thus, the     purpose of this project is to examine the acute effects of aerobic exercise on neuroplastic,     neurobiological, and mood indices of depression.   "
34070|NCT02839824|"     Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient     adherence to investigational products increases in the context of clinical trials. By the     same token, efficacy of interventions may be overestimated in clinical trials.      For this reason, an observational study to collect data on the effectiveness of several     colonic preparations when these are used under usual clinical practice is proposed.   "
34071|NCT02839811|"     The COBIOPHAD project targets the development of a highly sensitive, selective, and     multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the     most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a     retrospective study, BLC structures involved in drug hypersensitivity will be identified from     sera of allergic patients (versus controls) and coupled on the device.      A prospective study will be performed for the recruitment of samples corresponding to     patients with known IgE hypersensitivity to BLCs based on results from allergy tests and     clinical history. Controls will include: non-allergic individuals with known tolerance to     betalactams. The samples will be used for the validation of the COBIOPHAD device in real     settings.   "
34072|NCT02839798|"     This study is designed to evaluate the safety and preliminary efficacy of synchronized     transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST)     in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an open label     study in which subjects will receive treatment 5 days per week for 6 weeks.   "
34089|NCT02839577|"     The aim of the study is to determine the effect of steroid in High Volume Injection (HVI)     compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon     thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).      Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls     0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI     without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline).      All subjects will perform a 12-wk eccentric training program with further eccentric training     3 times per week from week 12 to week 24.      Clinical examinations and ultrasound will be performed at baseline (before treatment) with     follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any     possible changes and differences between the two groups.   "
39434|NCT02769468|"     The aim of the study is to compare the effect of 3 different skin temperature placement probe     in the case room on the admission temperature to the NICU in preterm infants. The authors aim     to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C).   "
34073|NCT02839785|"     SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8     and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of     pain in these populations was respectively 60 and 69% while it is about 35% in typically     developed children of the same age.      The main location of the pain for 60% of children with CP was the lower limbs, caused by     musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE     2, 50% of the children complained about pain during physical therapy.      If the pain is part of the management of physiotherapy, a recent review showed that for a     condition such as chronic back pain, the level of evidence of the effectiveness of     physiotherapy techniques in reducing pain is low. The effectiveness of these techniques would     include higher efficacy on anxiety than pain itself.      Despite significant involvement of physiotherapists in the management of pain, the focus on     pain should increase, in particular taking into account the procedural/induced pain (caused     by treatment).      In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to     reduce the pain of children during medical procedures. For the latter most of them require     the presence of two individuals to provide the therapy. This is unsuited for out-patient care     provided to the majority of children with CP.      Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination     with the treatment of several indications in child pain (migraine, postoperative pain, etc.).     Ibuprofen is commonly used in children during painful procedures and represented the 4th     molecule among prescribed per os analgesic drugs in 2008 in the United States.   "
34074|NCT02839772|"     An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a     research based skin management regimen compared to the current regimen. The experimental     group added 2% glycerine to the current skin care regimen and used 1 litre of water in the     water soak compared to the 6 litres used in the current regimen.   "
34075|NCT02839759|"     This RCT will have two arms: A control group that receives the standard of care from     audiologists and an experimental group that receives both the standard of care and the     at-home use of the TELLYHealth intervention. Subjects in each group will complete     questionnaires at enrollment, mid-study and at the end of the study.   "
34076|NCT02839746|"     Describe patient and physician assessed factors for patient well-being when treated with     Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous     antithrombotic treatment (switcher)   "
34098|NCT02839460|"     This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and     expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well     as healthy, physically active controls.   "
34293|NCT02836925|"     This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus     ledipasvir ± ribavirin (genotype 1, 3 and 4) or sofosbuvir + ribavirin (genotype 2) for     patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).   "
34077|NCT02839733|"     Background:      Cerebral palsy (CP) is the most common childhood motor disability. The neurotransmitter     dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in     motor skill learning. Genes that relate to DA function may affect a person s ability to learn     new cognitive or motor skills. Some children with CP can learn motor skills easily while     others have trouble. Researchers want to find out if DA gene variations cause some of this     variability.      Objectives:      To learn more about how DA and its related genes affect motor and cognitive learning in     people with and without CP.      Eligibility:      People ages 5 25 with and without CP who can:      Follow the protocol      Attend and perform the training sessions      Design:      Participants will be screened with:      Medical history      Physical exam      Blood draw for genetic tests      The study has 2 parts. Participants with CP can join both. Those without can join only Part     1.      All participants will have a baseline assessment: short motor skills test and blood draw.      Part 1:      Two 10-session training programs over 2 weeks. Cognitive training will be 2 sessions at the     clinic, 8 at home. Participants will perform memory tasks on a computer. All 10 motor     training sessions are at the clinic. Participants will step on lines in a virtual reality     environment.      Part 2:      Two lab training sessions at least 1 week apart. Participants will perform tasks on a      computer.      Participants with CP may have a brain MRI at 1 visit. They will lie on a table that slides     into a machine that takes pictures. They will be in the scanner about 45 minutes. They may     have a   "
34078|NCT02839720|"     This pilot phase II trial studies how well selumetinib works in treating patients with     neurofibromatosis type 1 and cutaneous neurofibromas. Selumetinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
34080|NCT02839694|"     Background:      Most patients who have surgery for cancer that has metastasized (spread) to the lungs later     get more metastases that cannot be treated with surgery or chemotherapy. The drug resistance     may be due to DNA changes in cancer cells that activate some genes and turn others off.     Researchers want to test a combination of drugs for people with metasteses. Decitabine (DAC)     may reverse the DNA changes. Tetrahydrouridine (THU) makes DAC last longer. Celecoxib may     slow the progression of cancer.      Objectives:      To determine a safe dose of DAC and THU by mouth. To see if DAC-THU with or without celecoxib     reactivates genes in lung metastases.      Eligibility:      Adults 18 years and older, with cancer in both lungs that can be treated with surgery.      Design:      Participants will be screened with:      Blood, lung, and heart tests      Scans      Tests for viruses      Pregnancy test      Participants will have blood and stool tests.      They will have surgery to remove metasteses in 1 lung.      About 3 weeks later, they will have lung scans. If the disease is not back, participants will     get DAC and THU with or without celecoxib, by mouth for 6 weeks.      Participants will have more scans. If the disease is not worse, they will continue the study     drugs for 4 more weeks.      Participants will have more scans and heart and lung tests. They will have surgery to remove     metasteses from the other lung.      Participants will have weekly blood and urine tests, plus several blood draws the first 2     days of taking the drugs.      Participants will have exams and blood tests before each surgery.      Participants will have follow-up visits 1 and 3 months after the second surgery.   "
34081|NCT02839681|"     Background:      Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a     protein on the surface of tumor cells in many types of tumors, including most lung cancers.     Researchers want to find a safe dose for the study drug for lung cancer. They want to see if     it can shrink tumors in mesothelin-positive lung cancer.      Objectives:      To test the safety and effectiveness of anetumab ravtansine for lung cancer.      Eligibility:      Adults 18 years and older who have lung cancer that has gotten worse on other therapy      Design:      Participants will be screened with:      Medical history      Physical exam      Tumor tissue sample. This can be from a previous procedure.      Blood and urine tests      Heart tests      Scans. For one scan, a small amount of radioactive substance is injected into the blood.      Eye exam      The study will have 21-day cycles.      On day 1 of each cycle, participants will get the study drug through a tube inserted in a     vein.      Participants will repeat a heart test in cycles 1 and 2.      They will have blood tests weekly in cycle 1, twice in all other cycles.      They will have scans every 6 weeks for the first 6 months, every 9 weeks until the end of     year 2, then every 12 weeks.      Participants will have samples of tumor tissue taken twice.      About 30 days after stopping the study drug, participants will have a follow-up visit. This     will include medical history, physical exam, blood and pregnancy tests, and heart and eye     tests.      Some will be called a few times a year to discuss their health and treatment.   "
34082|NCT02839668|"     Because neoplastic disease is one of the leading causes of death worldwide and breast cancer     is one of the most frequent neoplasia among women, the possibility of influencing the     evolution of patients starting from the moment of surgical intervention using a     perianesthesic intervention is a scientific topic of high interest. The study will compare     two anesthetic techniques and their efficiency in lowering the factors that can favorize the     dissemination of neoplasia and their role in the prevention of postoperative pain. The serum     level of vascular endothelial growth factor A (VEGF-A) will be determined before and after     the surgical intervention after using two different types of anesthesia (inhalational and     intravenous), and the immunohistochemical expression of vascular endothelial growth factor     receptors (VEGFR) will be determined on the excised tissue. For the two different types of     anesthesia a continuous infusion of lidocaine 1% will be associated. The study will compare     the short-term and long term-outcome of the patients assigned the two different types of     anesthesia and their immediate postoperative evolution .   "
34083|NCT02839655|"     The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in     Asia and begins to spread in Western countries. The main advantage of the technique is to     avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear     to improve esthetic consequences and body image. It is not surgery minimally invasive but     rather a way of remote access surgery.      Data from the literature including cohort studies and meta-analyzes attest the security of     the procedure in comparison with classic thyroid surgery (which remains the gold standard).     However there is few data on the effectiveness of the technique in terms of the completeness     of the surgery, according to the routine standard criteria used in endocrinology and     endocrine cancer, and no French medico-economic study has been performed.   "
34084|NCT02839642|"     Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease from the     parkinsonian syndrome group. It represents 5 to 10% of all parkinsonian syndromes and affects     3,000 to 10,000 persons in France. PSP is characterised by a doparesistant parkinsonism with     axial signs such as early gait instability and falls, oculomotor signs such as a vertical     gaze palsy, dysphagia and dysarthria, and both cognitive and behavioural disturbances. The     latter predominantly manifest as psycho-motor slowness, apathy and frontal executive     deficits. Swallowing impairments and falls may lead to life-threatening situations and death     occurs 6-9 years after disease onset.      Apart from L-dopa which may transiently and inconsistently improve motor symptoms no     effective symptomatic, disease-modifying or neuroprotective therapy is presently available to     reduce disability in any way. Therefore these patients often receive mostly non-medical care     such as physiotherapy and speech therapy.      In addition to dopaminergic degeneration there is evidence of cholinergic deficits in PSP     correlated with gait and balance impairments . This stands in contrast with the limited     number of studies of cholinergic augmentation strategies in PSP.      Trials of cholinesterase inhibitors in PSP have produced rather conflicting results:     donepezil improves cognition but deteriorates some motor functions whereas a case series of 5     PSP patients treated with rivastigmine found an improvement in several cognitive aspects and     no deterioration of motor functions .On the other hand in Parkinson's disease there is     convincing evidence of a positive effect of rivastigmine on cognition , apathy and falls     Investigators' hypothesis is that rivastigmine (an acetyl- and butyryl-cholinesterase     inhibitor) may reduce gait and postural impairment in PSP and may therefore limit the number     of falls and their consequences both in terms of injuries sustained (fractures etc...) and on     the patients' autonomy. In addition investigators hypothesise that rivastigmine may also     reduce the cognitive and behavioural impairment associated with PSP. Taken together these     improvements are likely to produce a significant effect on the patients' quality of life and     their caregiver burden.   "
34085|NCT02839629|"     A study to describe and evaluate patient characteristics and clinical outcomes in Subjects     with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.   "
34086|NCT02839616|"     The Institutional Registry of Liver Transplantation is a system for data collection related     to patients with liver disease who are possible candidates for liver transplantion. This tool     was designed by a multidisciplinary team that includes hepatologists, surgeons, informatics     and biostatisticians. It intends to collect the information from the clinical evaluation,     physical examination, complementary diagnostic methods and laboratory data. The information     is captured sistematically, following structured, standardized and monitored processess to     ensure the quality of the data obtained.      The aim is to use the available technology to generate a complete database that can be used     to answer research questions.   "
34087|NCT02839603|"     To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani     infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to     inform the feasibility of a larger study exploring a screen and treat strategy for VL in HIV     co-infected individuals in East-Africa (Ethiopia).   "
34088|NCT02839590|"     There are currently many surgical options for patients with glaucoma and ocular hypertension     (OHT), including the Hydrus Microstent implant, HiFU (High intensity Focused ultrasound),     STAR flo, Kahook Dual Blade, Diode laser, trabeculectomy and the Baerveldt implant, but     little is known about how these different surgical techniques used to treat glaucoma affect     the flow of fluid through and out of the eye (aqueous dynamics).   "
34150|NCT02838784|"     This study will compare the proportion of patients who have wound closure within 12 weeks as     well as the time to wound closure in patients receiving Artacent™ versus standard of care for     treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be     assessed at 6 months via a telephone survey   "
34091|NCT02839551|"     Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in     the absence of contraindications), but there are no standardized protocols and most groups     use hypothesis (clinically-driven) protocols.      investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171     patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they     identified optimal doses to include in a data-driven protocol. This data-driven protocol will     be applied to new prospective patients, to test its safety and benefits (gain in time,     hospital and patient benefits).   "
34092|NCT02839538|"     Background and Objectives: Postoperative analgesia and early recovery are relevant for     hospital discharge after hemorrhoidectomy. This study investigated the postoperative     analgesic effect with local infiltration compared with spinal block.      Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG)     received local infiltration under general anaesthesia; spinal group (SG) received a     subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol     infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5%     hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1%     lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation,     motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse     effects.   "
34093|NCT02839525|"     The study is a randomized, double-blinded, placebo-controlled trial that will include the     participation of 69 women, aged 18-40 years. The aim of the study is to test nutritional     strategies that help to minimize the effects of muscle damage induced by exercise.      The procedures will be performed at the Federal University of Health of Porto Alegre     (UFCSPA).   "
34094|NCT02839512|"     This is a single center study to assess metabolic effects in subjects after a Jejunal to     Ileal Diversion procedure was performed using colonoscopes.   "
34095|NCT02839499|"     Obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over 60     years with major consequences especially on the cardiovascular system.      This syndrome consists of a staff of the pharyngeal muscles. These muscles are also involved     in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet,     logically leading to atrophy of the muscles aerodigestive crossroads.      Muscle wasting ENT induced a mixed food could promote collapsibility of VAS, exposing the     individual to a higher risk of apnea and hypopnea during sleep.      The objective of this study is to determine if there is a significant increase in the     prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term     care units, receiving a mixed food compared to residents in supply to normal texture.   "
34096|NCT02839486|"     The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during     elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata:     neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.   "
34097|NCT02839473|"     The primary objective consisted of avoiding deterioration and/or restoring the integrity of     the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2     radiation dermatitis.   "
34099|NCT02839447|"     The purpose of this study is to determine if elevations in oxidative stress, as measured by     oxidation-reduction potential (ORP), can distinguish between semen samples from men with     abnormal semen parameters from those with normal semen parameters. Static ORP (sORP) results,     measured by the MiOXSYS System- a novel technology, will be compared to the current World     Health Organization (WHO) semen analysis parameters (5th Edition WHO Laboratory Manual for     the Examination and Processing of Human Semen [2010]).   "
34100|NCT02839434|"     Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive     cardiac procedures .      Additional parenteral anticoagulation is necessary for these procedures (FA ablation and     invasive coronary explorations).      The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting     time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This goal is the     same whether the patient is on oral anticoagulant treatment or not, and regardless of the     initial level of anticoagulation.      The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well     documented, but few data have been published on the effects of heparin monitoring tests,     particularly on the ACT.      The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses     to administer to optimize the efficacy / safety of invasive procedures in cardiology.   "
34101|NCT02839421|"     The aim of the present study is to evaluate the clinical and microbiological efficacy of     moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in     treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated     to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria.     The primary outcome variable to determine the superiority of one treatment over the others     would be differences between groups for means CAL changes at 6 months post-treatment.     Secondary outcome variables include differences between therapies for the mean changes in the     mean levels of PD and the proportion of BOP.   "
34102|NCT02839408|"     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of     Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an     adjunct to scaling and root planning (SRP).      Material and methods: Fifty-four chronic periodontitis patients will be recruited and     monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12     months after therapy. All patients will receive scaling and root planning and randomly will     be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental     (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used     once per day during 3 months. Antibiotic will be used once per day during 5 days.   "
34151|NCT02838771|"     The aim of this research was to develop a dysphagia screening measure and evaluate the     prevalence of dysphagia and its clinical manifestation in different in age population groups.   "
45148|NCT02694744|"     The purpose of this study is to evaluate the efficacy and safety of patiromer (the     investigational medication) administered once daily (QD) when given with food compared to     without food for the treatment of hyperkalemia (high potassium in the blood).   "
34103|NCT02839395|"     The human eye has a dual role, which is reflected by the various photo-receptors used for     vision of images and colors ,Image forming photoreceptors (IFP) and for entrainment of our     Biological clock located in the hypothalamus through the retinal ganglions known as     non-image forming photoreceptors (NIFP). The recently discovered new photo-pigment melanopsin     which is sensitive to short wavelength (SWL) illumination exists in the-NIFP. The axons of     the NIFP form a special nerve known as the Retino-hypothalamic-tract (RHT) that transfers the     SWL signal to the biological clock resulting in suppression of pineal melatonin (MLT)     production. This is the basic mechanism by which environmental light/dark cycles entrain the     biological clock and transfer the message to organs, tissues and cell.      The American Medical Association (AMA) issued a resolution in 2012 stating that light at     night constitutes environmental pollution because it violates the daily cycles, including the     waking and sleeping cycles, and suppresses the secretion of melatonin from the pineal gland     at night. Results of other studies have shown that exposure to artificial light at night     (ALAN) and mainly those emerging from SWL sources suppresses MLT-produced in the pineal     gland. Computers, tablets, TVs, and smart-phones screens emit SWL illumination, during the     day and night hours, whether as active or passive users. The results of previous studies show     that, exposure to SWL-ALAN illumination suppresses MLT-secretion and disrupts sleep patterns.     In order to understand better the effect of SWL-exposure emerging from screens on human     behavior and health, the investigators will study the effects of SWL-exposure on the     structure and quality of sleep, cognitive functioning in Continous Performance Test (CPT     III), emotional state, and physiological, variables (melatonin secretion levels and body     temperature) that were not tested in previous studies.   "
34104|NCT02839382|"     The purpose of this project is to build capacity for quality improvement (QI) in small     primary care practices across Washington, Oregon and Idaho by improving risk factors for     heart attacks such as blood pressure, cholesterol and smoking. The Northwest Coalition for     Primary Care Practice Support will assist practices by providing them with a QI coach,     creating group learning opportunities, and conducting educational outreach activities. An     innovative study design will be used to determine what levels and types of support are most     helpful and effective.   "
34105|NCT02839369|"     The goal of the present study was to look at the effect of changing walking parameters on the     dynamic walking characteristics among children post severe traumatic brain injury, children     with cerebral palsy and typically developed controls.   "
34106|NCT02839356|"     Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a     well-recognized complication with significant morbidity and even mortality. A variety of     possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema     caused by manipulations during cannulation or endoscopic treatment has received the most     attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice,     and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical     application of epinephrine on the papilla may reduce papillary edema. Moreover, it is     reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it     is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after     endoscopic retrograde cholangiopancreatography. We therefore designed a prospective     randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after     ERCP.   "
34107|NCT02839343|"     The purpose of this study is to compare any good and bad effects of using chemotherapy     compared to chemotherapy and radiation prior to surgery. This study will allow the     researchers to know whether which approach is better, the same, or worse than the other.   "
34413|NCT02835352|"     This study evaluates the impact of essential oils massage on anxiety of patients who are     suffering from cancer at a metastasis stage. Half of patients will be massaged first by     essential oils and then by oil only. The other half will be massaged first by oil and then by     essential oils.   "
34108|NCT02839330|"     This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots     of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18     years of age receiving the vaccine and 798 healthy adults receiving placebo. Subjects will be     randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment will     be stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety     assessment of the entire age spectrum.   "
34109|NCT02839317|"     The cause of CD could be different according to age at onset of CD symptoms. Indeed we know     that some very young patients at CD diagnosis have particular genetic variants as     abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way,     the microbiota also undergoes substantial changes at the extremes of life, in infants and     older people and the ramifications of which are very few being explored. The comparison of     microbiota by principal component analysis and genetic profile of patients with CD beginning     at the extremes of life could help us to better known physiopathology of CD according to age     and provide arguments that CD beginning at the extremes of life could be different diseases.      The aim of the study is to ascertain through population-based study the hypothesis that gut     microbiota is different between paediatric-onset and elderly-onset CD patients in relation     with genetic and environmental mechanisms. The results will provide a better knowledge of the     etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD     onset (i.e. according to the gut bacteria involved).   "
34110|NCT02839304|"     The objective of the study is to demonstrate the safety and feasibility of the PolarStar     system is subjects with Paroxysmal, Persistent and Long-Standing Persistent Atrial     Fibrillation.   "
34111|NCT02839291|"     To evaluate the current medical practice and its influence on health-related quality of life,     in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or     denosumab) for at least one year.   "
34112|NCT02839278|"     The aim of the study is to investigate in vitro the impact of a novel anti-inflammatory     treatment on costimulatory molecules expressed on monocytes.   "
34113|NCT02839265|"     Based on promising data from our laboratory demonstrating synergy between ablative local     radiotherapy and FLT3 ligand immunotherapy in murine NSCLC models, investigators are     performing a phase II study combining FLT3L immunotherapy and SBRT for patients with advanced     NSCLC that has progressed following standard systemic therapy. All patients will receive     daily subcutaneous injections of CDX-301 (75 µg/kg) for 5 days, beginning on the first day of     SBRT. SBRT will be delivered to a single pulmonary lesion. Depending on the size and location     of the target lesion, the SBRT regimen will be 34 Gy x 1 (peripheral tumors smaller than 2 cm     and not adjacent to the chest wall), 18 Gy x 3 (peripheral tumors not eligible for 34 Gy x     1), or 10 Gy x 5 (central tumors). The primary endpoint will be progression-free survival at     4 months, defined using immune-related response criteria (irRC). A total of 29 patients will     be enrolled.   "
34114|NCT02839252|"     The specific aims of this pilot study are to:        1. Evaluate the effectiveness of the asthma education intervention on asthma knowledge        2. Determine whether the asthma education intervention improves child and parent asthma          treatment self-efficacy      Our hypothesis is that the asthma education intervention will significantly improve asthma     knowledge and asthma self-efficacy at 1 month post-intervention as compared to controls.   "
34115|NCT02839239|"     The objective of this study is to determine an efficacy of the combination of L. rhamnosus     19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in     infants aged 4 through 12 weeks with IC. The active group of infants will receive     lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as     oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at     the end of intervention to define a difference between the groups   "
34116|NCT02839226|"     This prospective, placebo-controlled, double blind, randomized study is designed to assess     the healing effects of AR/101 on chronic Hard-to-Heal wound(s) of different etiologies     including arterial ulcers, diabetic ulcers and venous ulcers, of at least 3 months duration.     After collection of comprehensive medical data to confirm eligibility of patient and     obtaining informed consent , patients will enter Screening run-in Period where all wounds     will be cleaned if necessary by surgical debridement and irrigation (isotonic solution) prior     to initiation (run-in phase) of the study according to physician's instructions. During the     14 day screening period, all subjects will receive standard of care (SoC) on a daily basis,     as per indication and patients status, according to physicians instructions. Wounds will be     morphologically assessed by the treating physician and by photographic evaluation by the PI     once a week - at days 7 and 14 of the screening run-in phase. Following the run-in period,     Subjects with wounds of ≥ 5cm2 and ≤100 cm2 of at least 3 months duration that fail to     respond to treatment with SoC during the screening run-in phase will be enrolled into the     study. Eligible subjects with wounds will be randomized and treated topically with AR/101+     SoC or placebo +SoC once daily for up to 14 days. During this treatment phase I, depending on     their wound size and wound type, subjects will receive treatment dose applied topically daily     and wounds will be dressed according to physician's instructions. Wounds will be photographed     daily and assessed by the treating physician in the clinic once a week (at the end of each     weekly period). During the treatment period, adverse events and concomitant medications will     be monitored; wounds will be morphologically assessed by photo documentation and followed for     wound bed progression and granulation tissue formation. At the end of Treatment period I,     patient's wounds will be analyzed and all patients from both treatment arms with wound score     0-2 will be assigned to receive the study drug for and additional up to 14 days treatment     phase II in full accordance with the treatment regimen described in Treatment phase I. A     termination visit will be performed at day 14 of Treatment phase I or II or earlier if the     wound has reached the maximum score on the granulation scale or if the wound is ready for     skin grafting; or in any case of early withdrawal that is not due to withdrawal of consent.   "
34127|NCT02839083|"     Breast surgeries are usually associated with significant postoperative pain. Suitability of     analgesic technique after breast surgery is always questionable. The aim of this study is to     compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance     as regards to potential complications and analgesic efficacy of both techniques in the first     24 h after modified radical mastectomy.   "
34128|NCT02839070|"     The study is a combination of outpatient and inpatient monitoring. During the 27-day     inpatient portion of the study, the individual's sleep-wake schedule will be varied daily.     Volunteers will be randomized to a regular or irregular inpatient schedule.   "
34129|NCT02839057|"     Fractures of the second cervical vertebra (C2) are the most common spinal fracture among the     elderly. Non-surgical treatment comprises of cervical collar treatment for 12 weeks, while     surgical treatment for elderly could mean posterior fixation C1-C2 without collar treatment     or anterior screw osteosynthesis C2 with 6 weeks of collar treatment. A meta-analysis of     retrospective studies has recently found an improved survival with surgical treatment. This     national registry study is designed to estimate the survival of non-surgical and surgical     treatment in a population-based cohort.   "
34117|NCT02839213|"     The management of normal labor is both an art and a science. For decades, health providers     have worked to manage labor actively and safely, with the goal of shortening the duration of     painful labor. Reduction of Cesarean sections and other fetal and maternal complications is     also an important aspect of labor management.      The safety of active management of labor has been demonstrated by several prospective     randomized clinical trials. A shorter duration of labor from admission to delivery has also     been consistently reported in numerous studies of women treated with the active management     protocol.Hyoscine butylbromide belongs to the parasympatholytic group of drugs and is a     semisynthetic derivative of scopolamine. It is an effective antispasmodic drug without the     untoward side effects of atropine. Hyoscine butylbromide is a quaternary ammonium compound     and has peripheral anticholinergic action, but no central action as it does not cross the     blood-brain barrier. Hyoscine butylbromide acts primarily by blocking the transmission of     neural impulses in the intraneural parasympathetic ganglia of abdominal organs, apparently     inhibiting cholinergic transmission in the synapses of the abdominal and pelvic     parasympathetic ganglia, thus relieving spasms in the smooth muscles of gastrointestinal,     biliary, urinary tract, and female genital organs, especially the cervico-uterine plexus,     thus aiding cervical dilatation.      Spasmolytic drugs are frequently employed in delivery rooms to overcome cervical spasms and     thus reduce the duration of labor.      Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals in     the world. The mechanism by which it acts in the context of labor has not yet been     elucidated, and evidence of its efficacy has been largely anecdotal.      Major studies have been carried out to evaluate the effects of the injectable or suppository     form of Hyoscine butyl bromide on cervical dilatation; a majority of these studies     demonstrated the efficacy of Hyoscine butyl bromide in augmenting labor. However, a few     studies showed no effect of Hyoscine Butyl bromide on accelerating labor. In addition, some     studies also used oxytocin in active management of labor, which would certainly affect the     duration of labor and increase bias in the results. The specific objectives of this study     will be to assess whether Hyoscine butyl bromide is effective in hastening cervical     effacement and dilatation, thus shortening the duration of the first and second stages of     labor with or without labor augmentation. We also intended to determine whether the use of     Hyoscine butyl bromide in the first and second stages of labor has any associated increases     in complications, such as an increase in blood loss or the rate of cesarean deliveries.   "
34118|NCT02839200|"     The primary objective of this study is to assess the effect of ACT-541468 on a measure of     sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in subjects with     insomnia disorder.   "
34119|NCT02839187|"     The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients, who     responded to strict physiological criteria typical of AD pathology. The objective of the     present study was to identify the earliest alterations in cerebral connections that could     contribute to the initial episodic memory impairment.   "
34120|NCT02839174|"     The investigators have identified a support group on social media with ~1500 members     (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted     diet. Many participants report exceptionally low HbA1C and insulin requirements. If these     anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical     trial would be warranted.      The investigators propose to survey the above-mentioned group and their professional diabetes     care providers to characterize glycemic control and explore associated dietary and diabetes     care factors.   "
34121|NCT02839161|"     Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in     hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children     will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the     Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with     sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately     Days 0, 56, and 112 or 180.   "
34122|NCT02839148|"     This study will provide a tool for researchers to measure important outcomes in relation to     trial of intervention to reduce or prevent stunting.      Hypothesis: We assume that appetite score will be associated with improvement in growth and     development parameters of children given the nutrition and psychosocial stimulation     intervention      Objectives:      To explore maternal perception regarding childhood stunting To develop and validate an     appetite measuring tool To assess the appetite status of young children To examine the     relationship between appetite score, growth and development, potential biomarkers of     appetite, child food intake and intestinal inflammation of the children.      Methods: In the first phase, a qualitative study will be conducted to explore maternal     perception regarding childhood stunting and to develop a tool- the Early Childhood Appetite     and Satiety Tool(ECAST) using mixed method approach (qualitative and quantitative). In the     second phase, a community-based trial will be conducted with 50 stunted children of aged     12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children     (non-stunted).   "
34123|NCT02839135|"     In this comparative bioavailability and in vivo skin adhesion study, the impact of minor     changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and     change of the manufacturing line of the micro porous membrane will be tested.   "
34124|NCT02839122|"     This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic     interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy     male volunteers.   "
34193|NCT02838225|"     Our study is a prospective, non-inferior, randomized phase II clinical trial, to compare the     efficacy and safety profiles of DA versus DAC as adjuvant chemotherapy regimens for     early-stage breast cancer patients.   "
34125|NCT02839109|"     In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by     surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of the     patients had no residual tumor (ypT0N0) at pathologic examination. The absolute survival     benefit of response to nCRT is 15%, but still 14% of the patients develop locoregional     failure in the CROSS trial. 18F-fluorodeoxyglucose positron emission tomography with computed     tomography ((FDG-PET-CT) is able to distinct responders from non-responders, but still misses     significant clinical evidence. Whole-body diffusion-weighted imaging (DWI) magnetic resonance     imaging (MRI) has shown potential benefits, which might be enhanced by combining both     methods. PET/CT and DWI-MRI more precisely correlate anatomic and metabolic FDG-avid lesions     and seem to assess post-treatment changes, especially regarding nodal staging. Both     techniques claim an important role in selection of patients with clinical complete response     (cCR) and indirectly with pathologic complete response (pCR) after nCRT. However, the exact     role and complementary effects of both techniques is still unknown.      For appropriate judgment of response, secure standard endoscopic ultrasonography (EUS) with     fine needle aspiration (FNA) / biopsy of potential suspected lesions, both nodal or residual     tumor, seen on PET/CT or DWI/MRI or during EUS will be performed <2 weeks before surgery,     approximately 6-10 weeks after nCRT and compared with the situation at primary staging.     Patients with clinical complete response (cCR) resembling pathologic response (pCR= ypT0N0)     after nCRT may refrain from surgical resection and related morbidity and mortality. However,     patients without early (2wk after commencement) response during nCRT course may not benefit     from nCRT.      DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Apparent diffusion     coefficient (ADC), which indirectly measures tissue density, can be used to determine the     likelihood of tumor response to treatment. High ADC before treatment has shown to predict an     unfavorable response. Tumors with low ADC values on presentation generally respond better to     treatment. An increased ADC in patients during and after nCRT could be used to predict early     pathologic response i.e. discrimination of responders and non-responders to nCRT.   "
34126|NCT02839096|"     The investigators will randomize women diagnosed with anemia in the mid-trimester of     pregnancy to once or twice daily iron supplementation   "
34130|NCT02839044|"     Arterial calcification is an independent predictor of coronary events associated with a 3-4     fold increased risk of cardiovascular events. Currently, no effective intervention exists to     reduce arterial calcification. However, recent studies showed that vitamin K may reduce     ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification.      The primary objective is to determine if MK-7 supplementation leads to stabilization or     attenuation of ongoing calcium deposition in the femoral artery as quantified by 18F-NaF     PET/CT imaging in patients with type 2 diabetes and arterial disease.   "
34131|NCT02839031|"     Diabetes mellitus in children and adolescents is a source of stress and poor quality of life     for themselves and their family. Development of adaptive coping strategies may be improved by     focused parent and children training. This study assesses a cognitive behavioral treatment     (CBT) for children/adolescents with diabetes and their parents in comparison with standard     health educational interventions. The investigators main aim is to verify that the CBT     program improves overall balance of glycaemia better than phone contact without CBT content     (control group). Secondary objectives are expected improvements of health-related quality of     life and coping styles in parents and children.   "
34132|NCT02839018|"     Little is known about nutritional Parameters that potentially influence the course of     intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the     nutritional profiles in blood, urine and muscle in respective patients at risk.   "
34133|NCT02839005|"     Context: Cesarean section is the most common surgery in women, both in developed and     underdeveloped countries. However results are conflicting report in which material for     intradermal suturing get better aesthetic result. Objective: To compare the aesthetic     appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal     sutures for skin closure in women undergoing cesarean section first. Methods: This is a     clinical, prospective and randomized study which was conducted in the Department of     Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in     PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first     included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30)     polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a     score, according to Trimbos table, six months after surgery. Later the results were compared     to non-parametric statistical tests   "
34134|NCT02838992|"     To assess whether ATG Combined With Cyclophosphamide and cord blood infusion can accelerate     hematopoietic reconstruction in severe aplastic anemia patients and improve clinical curative     effect and safety   "
34135|NCT02838979|"     The primary goal of proposed investigation is to study the impact of oral glutamine     supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial     energetics and vascular function using 31P magnetic resonance spectroscopy and optical     spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to     describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as     well as inflammatory and oxidative stress biomarkers among persons with chronic kidney     disease.   "
34136|NCT02838966|"     The purpose of this study is to determine the optimal effective dose for preoperative     nutritional supplementation with immunomodulators on immune function and perioperative     outcomes following pancreaticoduodenectomy for pancreatic adenocarcinoma.   "
34137|NCT02838953|"     To determine whether the COPD impairs the diaphragmatic mobility (DM), and verify     improvements after an inpatient pulmonary rehabilitation (PR).      Ultrasonography on M-mode will assess the diaphragmatic mobility at rest breathing and at     slow deep inspiration. Lung functions test, arterial blood gas analyses, six minute walk test     will be also performed, on COPD patients and healthy subjects.   "
34138|NCT02838940|"     Background      Preventive antibiotic treatment before performing invasive procedures is a basic element in     preventing infections. The essence of preventive antibiotic treatment is strengthening the     defense mechanisms of the immune system by preserving a certain drug levels in the blood. The     timing of giving the antibiotics is very important. Several research groups have tried to     check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in     serum and adipose tissue in women during cesarean. These groups presented conflicting     research results.      OBJECTIVE      This study will discuss the preventive antibiotic treatment levels accepted prior cesareans,     to determine:        1. What are the factors affecting the level of drug in the blood?        2. Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal          Inhibitory Concentration)?        3. Is the provision of usual preventive care also addresses the situations of metabolic          disorder?   "
34139|NCT02838927|"     Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none     exists specifically for France. Hypoparathyroidism could led to complications. Here, the     investigators plan to collect data about both epidemiology, medication and complication of     hypoparathyroidism in France.   "
34140|NCT02838914|"     The purpose of the study is to assess the reconstruction and inverse reconstruction in right     atrium by speckle tracking echocardiography combined with real-time three dimensional     echocardiography for atrial fibrillation patients before and after radiofrequency ablation     (RFCA)   "
34141|NCT02838901|"     This is a double-blind, randomized, placebo-controlled, pilot study. Participants will be     randomized to receive either beetroot juice or a beetroot juice placebo, as a dietary     supplement, for 30 days. Beetroot juice is high in nitrates, a chemical when ingested is     found to increase blood flow to the brain. The purpose of this research study is to determine     the safety and feasibility of using this nutritional intervention in (ischemic)stroke     survivors, and prove that plasma levels of nitrate and nitrite increase as expected.     Secondary outcomes includes measuring a comprehensive set of outcomes related to functional     status post-stroke, including mobility, upper extremity strength, cognition, depression, and     disability. Patients will also be randomized to MRI perfusion scanning in the region of the     stroke to measure cerebral blood flow.   "
34167|NCT02838563|"     Current scales are not suited to a direct measure for the elderly with cognitive disorders     and are difficult to handle for the care teams. In this context, a visual analog scale was     created to answer a single question How are you feeling now, immediately? with the help of     pictograms. This study aims to assess the validity and reliability of the Scale of Well-Being     Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre (EVIBE)) in     people with Alzheimer's disease or a related disease.   "
34142|NCT02838888|"     Screening colonoscopy is considered the gold standard for adenoma detection in the colon.     However, it has been shown that a considerable number of polyps can be missed during     screening colonoscopy. Until now the endoscopist himself is responsible for the detection of     adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect     lesions. Recently, a computer program was developed that can be used to recognize and extract     suspicious structure from colonoscopy video sequences. The program was built to automatically     detected colonic polyps and to highlight the polyps by colour marking. The program was now     refined so that the respective structures can be highlighted during real time colonoscopy.     The aim of this feasibility study is to test whether the software is applicable during real     time colonoscopy.   "
34143|NCT02838875|"     Background Neonatal hypoglycemia is one of the most common metabolic disorders in     neonatology. Maintaining stable levels of glucose in the transition from fetal life to life     after birth is very important. Yet, except for the recognizing of at-risk populations, there     are not many individual measures which can help and predict which newborns (from at-risk     populations) will develop hypoglycemia and which will not.      OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and     by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours     after birth in the population that is at increased risk of this complication in advance.   "
34144|NCT02838862|"     Although gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years     as rare tumors, their incidences are increasing. Due to their potential of early metastases     and their heterogenous response to therapy, these tumors are important clinical entities. A     major problem remains the impossibility to adequately predict tumors' response to treatment,     precluding an individualized therapy. Further, there is no method to efficiently screen these     tumors. Protein based analyses (proteomic analyses) gain in interest as methods to address     this problematic.      The present study was designed to investigate epidemiologic data of patients with GEP-NEN and     to answer following questions using proteomic analysis applied to existing pathology     specimens (paraffin-embedded specimens, FFPE): is it possible to explore protein signatures     in this type of tumors? Is the response to therapy predictable using specific protein     signatures? Is the tumor's tendency to metastasize related to specific protein signatures?   "
34145|NCT02838849|"     Twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of     life, fecal characteristics and microbiota) measured during a week of monitoring followed by     randomization to a 14 days course of increased fiber in diet or increased fiber and water     intake, with repetition of parameters measuring at the end.   "
34146|NCT02838836|"     Patients with resectable solid primary cancers and even limited number of metastases are     potentially curable. However, most patients develop recurrences despite surgery. Circulating     and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the     blood, urine and bone marrow will increase understanding of cancer spread and advance     knowledge to develop individualized therapies.   "
34147|NCT02838823|"     This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody     JS001, as a monotherapy in patients with triple negative breast cancer who have failed in     routine systemic treatment. The study will be conducted in 2 parts: dose escalation and     cohort expansion to investigate tolerability and efficacy.   "
34148|NCT02838810|"     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with     sequential treatment of pegylated interferon alpha and NAs.   "
34149|NCT02838797|"     This is a study to determine the safety and tolerability of a new medicine (RQ10) for     gastrointestinal symptoms in Parkinson's disease. The investigators will also begin to look     at the effect of this medicine on gastrointestinal problems. The results will determine if     future studies are appropriate. In this study, RQ10 will be compared to a placebo (a     look-alike inactive substance). Participation will include multiple office visits.     Approximately 48 people will participate.   "
34194|NCT02838212|"     The purpose of this study is to determine the incidence of drug-related deaths in a     university hospital during the year 2015   "
34152|NCT02838758|"     The purpose of this study is to evaluate the effectiveness of a device that delivers freezing     temperature compared to injecting lidocaine (an anesthetic medication) in providing pain     relief to patients with disorganized nerve bundle between the toes, also known as Morton's     neuroma. The same ultrasound technology that the obstetricians use to visualize a fetus     inside a pregnant woman will be used to help the study physician to locate the Morton's     neuroma while precisely delivering the freezing temperature and lidocaine near the nerve.   "
34153|NCT02838745|"     Primary Objective      To determine the maximum tolerated dose (MTD) of intrathoracic administration of pemetrexed     when given in conjunction with cisplatin in patients with resectable malignant pleural     mesothelioma MPM.      Secondary Objectives      To determine the toxicity and grades associated with cytoreductive surgery and Hyperthermic     Intraoperative Chemotherapy HIOC with cisplatin and pemetrexed in patients with resectable     MPM.      To assess overall survival and progression-free survival after PD or EPP and HIOC with     cisplatin and pemetrexed for MPM      Correlative Objectives      To characterize the pharmacokinetics and pharmacodynamics of pemetrexed when administered as     a hyperthermic intrathoracic lavage after PD or EPP      To determine whether the degree of thymidylate synthase and ERCC1 gene expression in MPM     tissue correlates with clinical response to pemetrexed.   "
34154|NCT02838732|"     In this project, the investigators aim to investigate if daily carnitine supplementation     could induce TMAO productivity of vegetarian gut microbiota and through which the TMAO     producers might be disclosed.   "
34166|NCT02838576|"     Arthralgia has been a common complaint in postmenopausal period which seems to be involved     with estrogen depletion, although, its pathophysiology isn´t completely clarified. It seems     to relate with the level of physical activity, climacteric symptoms and pain catastrophizing.     In view of the multiple dimensions involved in arthralgia in postmenopausal women which     characterize it as a complex phenomenon, this study aims to describe the effects of hormone     replacement therapy in women aged between 45 and 55 years, considering estrogen as a possible     anti-nociceptive factor.   "
34155|NCT02838719|"     Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides     analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal     wall. In the past, a number of adjuvants have been added to the local anaesthetics in     peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In     recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics     in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure     and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When     added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to     prolong the analgesia time. A number of previous studies have also shown an opioid sparing     effect of steroids, when used intravenously perioperatively. Though previous studies have     shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane     block prolongs the duration of block, however it is not known whether this effect of     dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in     this study planned to compare the effectiveness of dexamethasone on quality and duration of     analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane     block versus when given systemically by intravenous route along with transverse abdominis     plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic     procedures under general anaesthesia.   "
34156|NCT02838706|"     The overall aim of the study is to investigate the time difference in the diagnosing of     anemia among elderly with hip fracture, between measurements with standard blood samples and     non-invasive SpHb-measuring. Another aim is to investigate the relationship between perfusion     index and prolong perioperative anemia and the potential impact on perioperative     complications.   "
34157|NCT02838693|"     The Bio-bank and Registry for StratIfication and Targeted intErventions in the Spectrum Of     Type 2 Diabetes (BRITE-SPOT) has been set up to prospectively collect clinical data and     biologically relevant samples from individuals with, and at risk for type 2 diabetes (T2D),     with the aim of delineating factors related to susceptibility, progression, complications and     response to treatment. Expanded from BRITE-SPOT, Assessing the Progression to Type - 2     Diabetes (APT-2D) is a prospective cohort with a focus on non-diabetics (normoglycemic or     prediabetic), to expand the sample size and depth of metabolic phenotyping in these upstream     groups, with the more targeted aim of delineating factors related to insulin sensitivity     versus secretion, that relate to progression to T2D.   "
34158|NCT02838680|"     To evaluate the safety and performance of the HLT System in patients with severe aortic     stenosis who present at high risk for aortic valve replacement surgery.   "
34159|NCT02838667|"     Nephrology participation in care of patients undergoing CABG could reduce AKI through     correction of modifiable risk factors and early detection and intervention of post-op AKI.   "
34160|NCT02838654|"     The purpose of this study is to analyze the reliability of epidural wave form during     cerivical epidural injection.   "
34161|NCT02838641|"     This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for     GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis     (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation     procedures, will be recruited for this study over a period of 18 months. Clinical likelihood     of TB will be systematically scored according to various clinical parameters. This will     determine the pre-test probability. Clinician will decide if anti-TB treatment is to be     started and patients will be followed up for a minimal of 18 months. Sensitivity,     specificity, positive, negative predictive values and the respective likelihood ratio will be     calculated accordingly.   "
34162|NCT02838628|"     In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment will be     evaluated in adult subjects with a clinical diagnosis of stable, clinically typical actinic     keratosis (AK) on the face or scalp.   "
34163|NCT02838615|"     The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural     spreading and provocation of concordant paresthesia, amount of radiation exposure and total     procedure time between transforaminal and parasagittal interlaminar epidural injection.   "
34195|NCT02838199|"     The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR)     with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with     bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with     symptomatic severe aortic valve stenosis.   "
34196|NCT02838186|"     The aim of this study is to evaluate the examination of the proximal colon with the     retroflexion colonoscopic technique in terms of feasibility and its possible additive     contribution in the detection of important lesions, namely polyps and cancers.   "
34197|NCT02838173|"     This study compare the Serratus block plane (SPB) and the local infiltration of the tissue     in the prevention of acute and chronic pain after breast cancer surgery.   "
34164|NCT02838602|"     This is a transnational prospective randomized trial comparing definitive carbon ion therapy     versus photon or combined photon and protontherapy as standard treatment for unresectable or     macroscopically uncompleted resected radioresistant tumors. Eligible tumors are axial     chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of     trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously     irradiated and without pre-planned surgery or chemotherapy after the clinical trial     procedure. Randomization is balanced 1 for 1. Patients of the experimental arm are treated in     carbon ions centers in Europe and patients of the standard arm are treated in France in their     closest participating radiotherapy center. An accrual of 250 patients is needed and an     absolute difference of 20% of relapse free survival at five years is awaited. The main     endpoint is the progression free survival at five years. The trial is supported by the French     program of clinical research and the national health insurance. Two associated studies are     carried out: a radiobiological one looking for radioresistance markers in the sarcomas     biopsies, and the second one is about medico economics.   "
34165|NCT02838589|"     This randomized controlled trial investigates the effect of a single dose of glucagon-like     peptide-1 (GLP-1) receptor agonist on cerebral blood flow velocity and cortical oxygination     in humans without cerebrovascular disease. This study serves as a control for a similar study     investigating the effect in stroke patients (ref. to EGRABIS1).   "
34168|NCT02838550|"     The aim of this study is to analyze the effect of a motivational online intervention (MOI)     using pedometers to increase physical activity in a sample of sedentary students. It will be     compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a     pedometer of new generation); MOI condition (access to a MOI and the use of a blinded     pedometer); and CONTROL condition (the use of a blinded pedometer).   "
34169|NCT02838537|"     This study will be conducted as a retrospective study of exposed and unexposed cohort of the     French population included all beneficiaries aged 65 and older. Exposed patients will be     matched to non exposed controls according age, gender and area of residence (ratio 1/4). Two     exposed arms and two non exposed control arms will be planned. Triptan arm will be user of     triptan defined as at least one recorded dispensing of any drug during the follow up, with no     recorded of any of these drugs during the previous 6 months (new or incident users). Ergot     arm will be user of ergot derivative defined as at least one recorded dispensing of any drug     during the follow up, with no recorded of any of these drugs during the previous 6 months     (new or incident users). This study involved data from the French National Health Insurance     Information System (Système National d‟Information Inter-Régimes de l‟Assurance Maladie ;     SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des     Systèmes d‟Informations, PMSI).        -  The SNIIRAM is a vast national medico-administrative database representing the most part          of the French population, allowing to identify and to describe precisely all medication          dispensations (name of drug, date of dispensing and quantity) including triptans and          other reimbursed medications.        -  The PMSI provides medical information about all patients admitted to hospital in France,          including discharge diagnoses encoded according ICD-10, medical procedures and French          diagnosis-related groups The research proposed is expected to provide an update and          nationally-consolidated estimation of the cardiovascular risk is associated to triptans          use in elderly population.   "
34170|NCT02838524|"     Partially assisted mechanical ventilation is ideally titrated to maintain adequate     inspiratory muscle activity (i.e. preventing disuse atrophy) while avoiding excessive (i.e.     fatiguing) inspiratory loads. The advent of ventilator modes enabling flow and pressure     assistance in proportion to patient inspiratory effort (i.e. Proportional Assist Ventilation     (PAV), Neurally-Adjusted Ventilator Assist (NAVA)) permit careful titration of ventilatory     support to achieve desired levels of patient inspiratory effort. However, data on the     acceptable range of values for inspiratory effort and respiratory muscle load-capacity     balance during mechanical ventilation are currently very limited. Such data are critical to     inform a physiologically sound evidence-based approach to titrating partially-assisted     ventilatory support. This study is designed to ascertain a physiologically acceptable range     of inspiratory effort in mechanically ventilated patients. The study protocol includes     measurements of the respiratory system during spontaneous breathing as well as evaluating the     diaphragm in real-time with the use of ultrasonography. The experimental design outlined in     the present study is predicated on the assumption that the range of values for inspiratory     effort and load-capacity balance observed in patients who are successfully weaned from     mechanical ventilation represent the safe and appropriate range of target values.   "
34198|NCT02838160|"     A randomized controlled triple blinded clinical trial with repeated measurements. The     reporting of this study complies with the CONSORT (Consolidated Standards of Reporting     Trials) statement for trials of non-pharmacological treatments.      The first aim of the study was to evaluate the effectiveness of the three competing     interventions on the critical care nurses' knowledge of, attitudes toward and adherence to 17     ventilator bundle components; the second aim was to determine the effectiveness of adherence     to 17 ventilator bundle components with pre-defined ventilator bundle on the psychological     factors of critical care nurses including nurses' stressors in intensive care unit (ICU),     perceived stress, trait and state anxieties; the third aim was to evaluate their impact on     the clinical outcomes; and the fourth aim was comparing KAP and psychological factors with     clinical outcomes.   "
34171|NCT02838511|"     Though most physicians believe they can identify frail patients, frailty is a poorly     characterized and complex clinical syndrome. Frailty has been categorized four dimensions by     de Vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy); 2)     biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and mood);     and, 4) social (social contact and support). 1 However, the pathophysiology of frailty     remains unclear. Two broad hypotheses have been proposed.      Deficit accumulation model: This hypothesis assumes that frailty occurs due to accumulation     and additive effect of multiple deficits, which occur across various domains. The more     deficits a person has, the more likely that person is to be frail. Frailty in this paradigm     is thus measured by identifying the number of positive factors/ deficits from a list. This is     used to create a proportional index of deficits, expressed as the ratio of deficits present     to the total number of deficits considered.      Many studies have used a modified frailty index (MFI) with 11 factors, which has shown to     correlate well with patient outcomes after surgery.      Phenotype model: Fried et al in 2001 proposed a phenotype based model, in which she     identified various clinical features that define frailty as a clinical syndrome. This     criterion, known as Fried index, consists of 5 factors- shrinking, weakness, exhaustion,     slowness, and low physical activity level. The Fried index is the most commonly used     phenotype-based assessment tool to evaluate frailty. An advantage is its ease-of use during     preoperative visits. Measurement of these factors in a perioperative setting was further     characterized by Makary et al in 2010, and was the basis for the Hopkins Frailty Score (HFS).      Currently, there exists no gold standard for assessment of frailty, especially in the     perioperative setting. In the absence of a well-accepted gold standard, a measurement of     frailty which would predict adverse postoperative outcomes would be useful. However, no study     has compared the prognostic abilities of HFS and MFI, after non-cardiac surgery.      All adult patients presenting to pre anesthesia evaluation clinic (PACE) at Cleveland Clinic     main campus will be included in the this prospective observational cohort study. Frailty     would be evaluated prospectively using HFS and components of MFI will be obtained from     Cleveland Clinic Perioperative Health Documentation System registry (PHDS).   "
34172|NCT02838498|"     To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP     cannulation success rate of novice surgical trainees.   "
34173|NCT02838485|"     Goals : ( a) to examine differences in cortical activity during hand movements with a mirror     compared to imagery of the same movements, and (b) to examine correlation between cortical     activity during imagery or mirror treatment and the pain and performance measures in finger     amputees.      A cross-sectional study of 20 subjects in a Functional Magnetic Resonance Imaging (fMRI)     preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue     Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and     Jebsen Taylor Hand Function Test will be used.   "
34201|NCT02838121|"     Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy     under mechanical unloading after THR implantation, further compromises the longevity of     implant. The prospective randomized study is aimed to investigate the periprosthetic bone     loss after primary total hip replacements.   "
34174|NCT02838472|"     Nicotinamide nucleotide transhydrogenase (NNT) mutations cause glucocorticoid and     mineralocorticoid deficiencies through decreased detoxification of reactive oxygen species     (ROS) in adrenocortical cells.      Ascorbic acid is well known by its high antioxidant activity due to the neutralization of     free radicals and other reactive oxygen species.      Preliminary results of NNT_p.G200S homozygous fibroblasts' treatment with 10 micro molar     L-ascorbic acid shows significant improvement in mitochondrial morphology and in ROS content.      The aim of this study is to figure out if ascorbic acid treatment improves the phenotype of     NNT patients by reducing ROS in their adrenocortical cells and preventing their apoptosis.   "
34175|NCT02838459|"     Using a prospective cohort design, the aim of this study is to compare the performance of     clinicians with prediction models in triaging trauma patients.   "
34176|NCT02838446|"     The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery     (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was     carried out on 36 patients. These patients were randomly assigned to two groups: classic     treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week)     physical therapy and rehabilitation intervention. Outcome measurements were based on upper     extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand     Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale),     range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation     with goniometer), grip strength (standard grip strength with Jamar hydraulic hand     dynamometer; lateral, palmar and pinch strength with pinch meter).   "
34177|NCT02838433|"     The impressive clinical responses obtained with immune checkpoint inhibitors     (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune     response might be required for their efficacy and highlight the critical role of antitumor T     cell immunity.      Recent progresses on the field of tumor immunology underline the critical role of CD4 helper     1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore,     monitoring tumor specific TH1 response could be relevant in cancer patients.      In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the     investigators team have previously described novel promiscuous peptides (referred as UCP:     Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor     antigen.      By using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this     study in melanoma before and after treatment.   "
34178|NCT02838420|"     This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and     safety of alectinib versus crizotinib and to evaluate the pharmacokinetics of alectinib in     asian participants with treatment-naive ALK-positive advanced NSCLC. Participants will be     randomized 2:1 into one of the two treatment groups to receive either alectinib (600     milligrams [mg] twice daily [BID]) or crizotinib (250 mg BID) orally, respectively.   "
34179|NCT02838407|"     The purpose of this study is to identify and characterise bacteria present in the lower     airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is     indicated by the clinician.   "
34180|NCT02838394|"     Dry Needling (DN) is a skilled intervention that uses acupuncture filiform needles that are     inserted into myofascial trigger points or other tissues underneath the skin. It is used to     treat myofascial or neuromusculoskeletal pain and to improve movement impairments. Although     more and more physical therapists add this treatment tool to their skill box, there is     uncertainty about its working mechanism and its efficacy. The latter is partially due to the     challenging task of finding and using a true control or sham treatment. The investigators     will use blunted needles, which will not perforate the skin, as sham treatment.      This study will assess if DN of a trigger point in the gluteal muscles increases pain     pressure threshold in that muscle, in another muscle innervated by the same segment (L4/5)     and in an area not supplied by the same segment (i.e. the ipsilateral posterior shoulder). In     addition, this study will assess if functionality, as measured by the Oswestry Disability     Index (ODI) and 15-point Global Rating of Change Scale (GRoC) questionnaires, improves after     2-3 treatments (1 week) of DN.   "
34181|NCT02838381|"     The aim of this study is to characterize the genetic and cellular immunological parameters of     metastatic digestive cancer patients having short and long responses to chemotherapy.   "
34182|NCT02838368|"     The incidence of type II glycogen-storage disease (Pompe disease) varies depending on     ethnicity and geographic region. As of 2010, nine studies have been published documenting the     incidence of Pompe disease. It is most common within the African American population, with an     incidence of 1 in 14,000. In the U.S. more broadly speaking, the combined incidence of all     three variants of the disease is 1 in 40,000. These estimates relied on the frequencies of     three mutations in the gene acid alpha-glucosidase (GAA), leading to variants of the disease.     Criteria for inclusion in the studies were often non-selective; in many cases, molecular     genetic screening was done at birth. With such a high prevalence of Pompe disease reported,     it is expected that large university medical centers specializing in neuromuscular diseases     would see a higher incidence of Pompe disease among their patients. From a comparable Italian     multicenter study, it appears that Pompe disease accounts for 3% of all patients presenting     with proximal weakness with or without CK elevation.      This study will measure the incidence of Pompe disease based on manifest laboratory     abnormality, namely low GAA enzyme activity. Analysis of GAA enzyme activity will be     determined through a blood sample of 4 mL. The study seeks to measure the epidemiology of     Pompe disease by symptomatically screening all patients who present with symptoms of hitherto     undiagnosed proximal weakness with or without elevation of the muscle enzyme, creatinine     kinase (CK), or elevation of CK alone, at thirteen academic tertiary neuromuscular practices     throughout the United States and Canada. Total recruitment is expected to be ~1,500     participants. It is anticipated that the number of incident Pompe cases in this cohort would     be between 3-5%, i.e. 45-75 newly diagnosed cases of Pompe disease.   "
34202|NCT02838108|"     This is an observational study examining outcomes and treatment patterns in a community-based     cohort of subjects with Chronic obstructive pulmonary disease (COPD) who are based in the     Kannapolis, NC area.   "
35321|NCT02823470|"     The study will evaluate the impact of smart adherence technology for monitoring on     lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with     Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane     Conductance Regulator (CFTR) mutation.   "
34183|NCT02838355|"     The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via nasal     cannula (ETCO2-NC) device may allow for earlier detection of respiratory complications. This     device will detect the amount of carbon dioxide exhaled with each breath and may better     predict high levels of this than traditional monitoring. This may reduce the number and     severity of respiratory issues. A convenience sample of 60 participants either scheduled for     continuous flow left ventricular assist device (CF-LVAD) implant or who have been readmitted     to an ICU with a CF-LVAD will be recruited and randomized to usual care or usual care plus     ETCO2-NC throughout their stay in the ICU.   "
34184|NCT02838342|"     This study will evaluate the potential immunomodulatory synergy of the association of     metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).   "
34185|NCT02838329|"     The purpose of this study is to determine weather using warmed (body temperature) 0.75%     Ropivicaine to convert labour epidural analgesia to surgical anaesthesia, reduces the onset     time of surgical block, compared to standard room temperature   "
34186|NCT02838316|"     The primary objective of this study is to evaluate the safety of Autologous Muscle Derived     Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of     tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or     radiotherapy for squamous cell cancer of the oropharynx.   "
34187|NCT02838303|"     The purpose of this study is to evaluate self-reported symptoms as a proxy for acute     organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms     and PchE activity in response to occupational acute organophosphate exposure among farmers in     Nepal.   "
34188|NCT02838290|"     Background: Over 39% of approximately 3,000 doctors (The British Medical Association     quarterly survey, 2015) admitted to frequently feeling drained, exhausted, overloaded, tired,     low and lacking energy. Such occupational distress may link to psychological and physical     difficulties in doctors and have negative outcomes for organization and patients. The aim of     the current study is to investigate the impact of an induction programme on occupational     distress of doctors.      Methods/design: Doctors will be invited to take part in an online research. Participants will     be randomly assigned to the experimental and control groups. Participants in the experimental     groups will complete one of the induction topics (about stress at work). Before and after an     induction programme participants will be asked to fill in an online survey about their     current occupational distress and organizational well-being.      Discussion: The investigators expect that doctors' psychological, physiological and     organizational well-being will improve after an induction programme which should serve as a     resource for better doctor's own health understanding.   "
34189|NCT02838277|"     The INSIGHT study aims to phenotype individuals with subcutaneous adipose tissue (SAT)     disorders specifically lipedema and Dercum's disease with an aim to find a cure for the SAT     in these disorders that is resistant to diet and exercise.   "
34190|NCT02838264|"     The purpose of this study is to estimate the effect of itraconazole on the single dose     pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.   "
34191|NCT02838251|"     About 15% to 30% of patients with venous leg ulcers have a peripheral arterial disease (PAD)     associated. The compression band is still a controversial issue in this context. It allows     the reduction of venous hypertension and edema, but it could potentially degrade the arterial     infusion of high levels of compression. The French High Authority for Health (HAS) defines     mixed ulcers by IPS between 0.5 and 0.9. Investigators distinguish mixed ulcers blood     predominance for IPS between 0.5 and 0.7; and mixed ulcers predominantly venous blood with     moderate involvement for IPS values between 0.7 and 0.9.      Several studies have shown that IPS> 0.8 allowed a high compression, between 30 and 40 mmHg.     In the case of mixed ulcers with IPS between 0.6 and 0.8, the HAS recommends using a lighter     compression, bit by elastic bands (exercising low power compression at rest) under medical     supervision, informing the patient to remove the bandage if pain or aggravation. It is     therefore necessary to adapt the compression therapy in case of venous ulcers associated with     arterial disease by providing a lower compression 30 mmHg short stretch. For HAS, IPS <0.6     against indicates compression.      A recent study showed that compression bit elastic bands could not only improve venous     return, but it would also increase the distal arterial flow in a patient population with     mixed ulcers. In this study, 25 patients had between IPS 0.5 and 0.8; or for certain patients     below the threshold of 0.6 indicates that against a compression according to HAS. To our     knowledge this is the only study that has examined the effect of compression on blood     perfusion.   "
34192|NCT02838238|"     Our study is a prospective, randomized phase II clinical trial, to compare the efficacy and     safety profiles of single X versus placebo as adjuvant chemotherapy regimens for elder breast     cancer patients.   "
34199|NCT02838147|"     Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance first diagnosed     during pregnancy [1]. It is associated with adverse pregnancy outcome for the mother, and the     fetus with consequences regarding future health and development of the neonate. Maternal     consequences include increased rate of operative and cesarean delivery, hypertensive     disorders during pregnancy and future risk for type 2 diabetes mellitus (T2DM) as well as     other aspects of the metabolic syndrome, such as obesity, cardiovascular morbidities and     recurrent GDM [2-4]. Also, children born to mothers affected by gestational hypertension have     been found to have higher body mass index (BMI), systolic blood pressure, glucose and insulin     levels [5]; this risk extends into adulthood, with an 8-fold increased risk of type 2     diabetes among young adults exposed to gestational diabetes during fetal life [6].      Of all types of diabetes, GDM accounts for approximately 90-95% of all cases [4, 7]. It     complicates up to 14% of all pregnancies. Its prevalence is increasing and parallels the     rising incidence of type 2 diabetes mellitus worldwide [3,4]. Risk factors for developing GDM     in pregnancy include obesity, previously GDM, glycosuria, family history, ethnicity and     hypertension [5,6].   "
34200|NCT02838134|"     Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the     consequences of postoperative pain and analgesia consumptions. The investigators' goal is to     establish the relationship between the use of deep neuromuscular blockade (NMB) during     laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the     investigators designed a trial in which patients scheduled for living donor nephrectomy are     randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will     be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.   "
34203|NCT02838095|"     To examine the neurobehavioural responses to two successive cycles of sleep restriction and     recovery in adolescents, and to determine the benefits of napping on cognitive performance,     alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and     no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15     days. The nap group received an afternoon sleep opportunity lasting 1 hour.   "
34204|NCT02838082|"     OSABI is a pilot study of a sleep hygiene protocol for sleep disruptions associated with TBI     during inpatient rehabilitation. Twenty participants will be allocated (by minimization)     either into a standard of care protocol or a sleep hygiene protocol for 4 weeks. Sleep     efficiency (via actigraphy), post traumatic amnesia (OLOG), agitation (Agitated Behavior     Scale) and cognitive function (Confusion Assessment Protocol) will be monitored during the     trial period to examine relationships among them.   "
34205|NCT02838069|"     ASCs will be administered via intra-articular use into the knee joint affected by OA where     they are expected to exert their therapeutic effects.      The objective of this clinical trial is to generate efficacy and tolerability profiles of     single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when     administered locally into a knee joint affected by OA after in vitro cell expansion. The     potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this     chronic and debilitating disease will be assessed by MRI after 1 and 2 years.      This will be a phase IIb, multi-centre, prospective, randomized, double-blind study,     comparing culture-expanded autologous ASC with placebo.   "
34206|NCT02838056|"     Traditionally, placement of the epidural catheter is based on hand feel of passing through     the ligamentum flavum as well as loss of resistance while injecting the air through the     needle. However, both are subjective and not necessarily encountered consistently. Moreover,     the onset of sensory block is usually slow, thus making confirmation of catheter position a     tough task and may delay the turnover of the operating room. The only way to confirm the     catheter position objectively without delaying surgery is to find a reliable indicator within     minutes of local anesthetic injection. In this study, we try to use the change of temperature     in the big toe as a surrogate indicator of correct epidural catheterization.   "
34207|NCT02838043|"     This study will be an 8-week open-label pilot study examining subjective and objective     changes in mood, anxiety, cognition, and sleep before and after the introduction of a     probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10     treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to     examine the full composition of the micro biome, the investigators will also be collecting     and analyzing fecal samples as well as blood samples to examine changes in plasma levels of     inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms     of any changes seen.   "
34208|NCT02838030|"     Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World     Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher     in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that     preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality.     Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far     there is no effective treatment to decrease the morbidity and mortality of this entity, so it     is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition     to the information the investigators have reduced the effect of these strategies on arterial     stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this     population. It is for this that is of interest to know the efficacy and safety of the     combination of L-arginine low dose, which is known as an important eNOS in NO production     substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the     prevention of preeclampsia and also determine their effect on arterial stiffness as a     noninvasive method, as is the applanation tonometry.   "
34247|NCT02837523|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Cystinosis     disease from plasma.   "
34248|NCT02837510|"     This study will examine how abstinence-induced brain changes contribute to smoking cessation     outcomes in treatment-seeking smokers.   "
34209|NCT02838017|"     The goal of this project is to identify a strategy to reduce wound complications in women who     undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin     incisions are closed by subcuticular sutures followed by either placement of Steri-Strips or     Dermabond. Either Steri-Strips or Dermabond can be placed over the wound as a covering but it     is unclear which may reduce wound complication rates. The hypothesis of this study is that     Dermabond will result in a reduction in wound complication rates when compared to     Steri-Strips. Previously published studies in non-obstetric populations have identified     Dermabond as a potential intervention to reduce wound complications. The eligible population     for this study will include women at NorthShore University HealthSystem Evanston Hospital and     University of Chicago Hospital who will undergo primary or repeat cesarean delivery via     Pfannenstiel skin incision. Women in the study will be randomized to receive either     Steri-Strips or Dermabond. The primary outcome to be evaluated will be wound complication     which will include wound infection (cellulitis or subcutaneous infection), wound separation     (partial or complete), wound seroma/hematoma. Secondary endpoints to be investigated include     cosmetic outcome, patient satisfaction, cost comparison, and difference in total time for     application.   "
34210|NCT02838004|"     This is an interventional, non-controlled, multicenter international trial with a prospective     design on one cohort of patients.   "
34211|NCT02837991|"     This is a study to determine the safety of CDX-014 and effectiveness (how well the drug     works).   "
34212|NCT02837978|"     This study is designed to observed prospectively the efficacy and safety of 6 months     treatment of Tacrolimus alone or with methotrexate (MTX) in moderate and severe Chinese RA     patients who shown insufficiency response or intolerance to DMARDs   "
34251|NCT02837471|"     The purpose of this prospective randomized controlled trial (RCT) is to evaluate the     feasibility and usability of a commercial pedometer and web application in a case-managed     home-based Cardiovascular disease prevention and rehabilitation program for French-speaking     Canadians.   "
34252|NCT02837458|"     The purpose of this study is to determine whether the transcutaneous application of     unmodulated high frequency alternating currents could produce a quickly conduction block of     peripheral nerve.   "
34213|NCT02837965|"     The study is an observational, multi-center, prospective, non-interventional and open-label     data collection study assessing outcomes, treatment patterns, adverse events and costs in     patients diagnosed with bullous pemphigoid. The patient enrollment period will be 1 year with     a follow-up (observation period) of 1 year for each patient. Four dermatology centres in     France will participate. The hypothesis to be answered by the study is that superpotent     topical corticosteroid therapy is properly used to treat bullous pemphigoid in real-world     life as recommended by French guidelines and whether this treatment influences the medical     costs by comparison with systemic therapies (e.g. methotrexate or prednisone).   "
34214|NCT02837952|"     This study is being conducted to determine the overall analgesic efficacy and safety of a     fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in     subjects who are experiencing post operative pain following surgical extraction of 3 or more     third molar teeth. A review of any reported adverse events will also be completed.   "
34215|NCT02837939|"     This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes     homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs,     chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections     in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..   "
34216|NCT02837926|"     The study aims to identify global and local determinants of HPV vaccine acceptability, HPV     vaccine uptake and compliance as well as identify logistics and programmatic issues in each     country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to     mid-aged women attending screening.   "
34217|NCT02837913|"     The primary aim of the current study will be to determine if the use of an underbody heating     mattress during cesarean sections will decrease the incidence of postoperative hypothermia,     defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia.     As part of the primary outcome the difference in the incidence of shivering, its severity,     and need for treatment will be investigated. As a secondary goal other maternal perioperative     outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning     after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length     of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to     skin' contact. The relationship between maternal hypothermia and newborn outcomes of     temperature and APGAR scores will also be evaluated.      Active preoperative and intraoperative warming may prevents inadvertent perioperative     hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The     underbody warming mattress may be a step towards finding a suitable form of warming that is     comfortable for awake patients, does not interfere with skin to skin contact and     maternal-fetal bonding.   "
34218|NCT02837900|"     The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy     of a second course of TPX-100 administered by intra-articular injection to subjects with     osteoarthritis of the knee who participated in study TPX-100-1.   "
34219|NCT02837887|"     This randomized clinical trial studies how well a computerized cognitive behavior therapy     program works in treating depression in patients with cancer. The cognitive behavior therapy     program uses a series of internet-delivered sessions intended to help patients identify and     change problematic patterns of thinking and behavior that maintain depression.   "
34220|NCT02837874|"     Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer.     The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of     dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric     stasis or obstruction. The investigators will assess complications, dumping syndrome and     quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for     gastric cancer.   "
34221|NCT02837861|"     A randomized, parallel-group, pilot study comparing the effect of the early addition of     intravenous protein to enteral feeding as tolerated versus enteral feedings as tolerated     alone immediately post traumatic injury.      Primary: To determine that early and adequate nutritional support will improve protein     economy in the first week post -injury as measured by nitrogen balance. We hypothesize that     an improvement in nitrogen balance with early maximized protein intake will support the     production of acute phase proteins, major antioxidants and the inflammatory response.      Secondary: Through the use of mass spectrometry (MS) and nuclear magnetic resonance (NMR)     technologies we will determine that our plan for early and adequate nutritional support with     adequate protein from day one post injury will alter the metabolomics profile when compared     to routine nutritional support.      Tertiary: For Specific Aim 3 we will measure several pro- and anti-inflammatory cytokines and     soluble proteins.   "
34222|NCT02837848|"     Rotator cuff tendinopathy (RCT) is the most frequent cause of shoulder pain. RCT is     frequently termed as impingement syndrome, based on the underlying mechanism in which the     subacromial space soft tissues (subacromial bursa, rotator cuff tendons and long head of the     biceps tendon) get encroached under the coracoacromial arch when the arm is elevated. RCT     contributes in the decrease in quality of life and function, and in inducing work     incapacities and sleep disorders.      Exercises, as conservative management, were shown to be effective in increasing function and     in decreasing pain related to RCT. However, the lack of studies comparing different types of     exercises (i.e. concentric, eccentric, scapular strengthening, proprioceptive, coactivation)     is reported by many systematic reviews. One type of exercise, coactivation strengthening,     could be more efficient. Coactivation strengthening implies a recruitment of the pectoralis     major and the latissimus dorsi while performing regular strengthening. When theses muscles     are recruited, the medio-inferior orientation of their tendons creates a force vector that     limits the superior translation of the humeral head, thus limits the subacromial narrowing.      The aim of this study is to evaluate the efficacy of coactivation strengthening exercises in     patient with RCT compared to regular strengthening exercises. Forty-two participants     diagnosed with RCT by an orthopaedic surgeon following a standardized protocol will be     randomised to either coactivation or regular strengthening exercises. Participants will     perform a 6-week exercise protocols. Outcomes will be measured at baseline, and at three,     six, 12, 18 and 24 weeks. The primary outcome is function assessed with the Disabilities of     arm, shoulder and Hand (DASH) questionnaire. Secondary outcomes focus on pain (visual analog     scale), quality of life (Western Ontario Rotator Cuff Index), impression of change (Patient     Global Impression of Change), subacromial distance (ultrasonography) and muscular strength     (manual dynamometer). Investigators expect that coactivation strengthening exercises will be     more efficient over the short and long term.      This trial will provide data to guide clinicians in the treatment of RCT to reduce recovery     time and to bring patients back as quickly as possible to work or usual function.   "
34429|NCT02835131|"     Congenital hyperinsulinism is a rare condition that can cause life-threatening hypoglycemia.     Current treatment for congenital hyperinsulinism is often suboptimal, and such individuals     may respond to a new somatostatin analog, pasireotide. This is a compassionate use study of     the effects of pasireotide on individuals with suboptimally treated congenital     hyperinsulinism.   "
34223|NCT02837835|"     Ceftazidime is a beta-lactam compound that exerts a time-dependent bactericidal effect.     Numerous arguments are in favor of continuous administration of ceftazidime, both for reasons     of clinical efficacy and to preserve bacteriological mutation. The investigators report a     prospective, single-center, parallel-group, randomized, controlled trial comparing two modes     of administration of ceftazidime, namely, continuous administration (loading dose of 20 mg/kg     of body weight followed by 60 mg/kg/day) versus intermittent administration (20 mg/kg over 30     min every 8 h) in 34 patients with ventilator-associated pneumonia due to Gram-negative     bacilli. The study was performed over 48 h with 13 and 18 assessments of serum ceftazidime in     the continuous-infusion group (group A) and the intermittent-fusion group (group B),     respectively. Bronchoalveolar lavage (BAL) was performed at steady state in both groups at 44     h to determine ceftazidime levels in the epithelial lining fluid. The investigators chose a     predefined threshold of 20 mg/liter for serum concentrations of ceftazidime because of     ecological conditions in our center.   "
34224|NCT02837822|"     It's well known that Spinal cord stimulation (SCS) changes the perception of chronic pain in     the area stimulated by epidural electrodes. However, we don't know the effect of this type of     stimulation on the perception of external sensations (temperature, touch, pressure, and     vibration) and sharp pain. Quantitative sensory testing (QST) is used to quantify     somatosensory phenotype. This QST battery tests different subtypes of nerve fibres (Aβ, Aδ     and C) involved in the transduction of sensory information from the periphery to the spinal     cord.      The purpose of this study is to evaluate the effects of the SCS on sensory perceptions of     patients with chronic pain (CRPS, FBSS). Sensorial perception tests will be carried out in     accordance with a standardized procedure (Rolke et al. Pain, 2006). For non-implanted     patients, an initial visit will be conducted before the operation. For all participants, two     other visits will take place at least 6 months after the operation to perform the tests with     and without stimulation.   "
34225|NCT02837809|"     The MILD project is a randomized lung cancer screening trial whose primary aim is to evaluate     the impact on mortality of early lung cancer detection through LDCT (low-dose computed     tomography) in 2 groups: a control group undergoing a program of primary prevention with     pulmonary function test evaluation and a group undergoing a periodic spiral CT associated     with primary prevention and pulmonary function test evaluation. This last one is also     randomized in two arms: yearly low-dose CT vs CT every 2 years.      MILD trial comprehensive design combines for the first time primary prevention (smoking     cessation) with early detection, and molecular risk profile through assessing the value of     blood and tissue biomarkers.   "
34226|NCT02837796|"     The investigators think that the two techniques of TOT (inside-out and outside-in) procedures     both statistically improve the sexual functions, psychosocial state and quality of life after     the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12     were statistically more increase in inside-out group than the outside-in group.   "
34227|NCT02837783|"     The objective of this trial is to determine the effect of linaclotide on abdominal girth in     irritable bowel syndrome with constipation (IBS-C) participants with the baseline symptoms of     abdominal bloating and an increased abdominal girth.   "
34228|NCT02837770|"     The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac     Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain     related to intravitreal injections will be evalutated.      Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.   "
34229|NCT02837757|"     Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with     metastatic renal cell carcinoma.      The objective of this study is to investigated the influence of everolimus immune modulation     on antitumor efficacy .   "
34230|NCT02837744|"     To evaluate Safety and Efficacy of Axiostat® hemostatic dressing as compared to Standard     Institutional Care product in terms of time to achieve hemostasis, post application     complication and comfort levels of patients.   "
34231|NCT02837731|"     This study assesses the mean difference in fluid balance at ICU discharge and associated     patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients     with refractory hypotension in an ICU setting.   "
34232|NCT02837718|"     Background Peripheral nerve blocks with use of USG allowed visualisation of the structures     and nerves and made the block administrations safe, quick and comfortable. However there are     few publications concerning the minimum local anesthetic volume capable of providing blocks.     In this study the investigastors aimed to find Minimum Effective Volume Of Local Anesthetic     For Ultrasound-Guided Axillary Brachial Plexus Block in hand, elbow and forehand operations.      Materials & Methods A total of 55 ASA I-II patients underwent hand surgery operation by     administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar,     median and radial nerves were seen and the minimum effective local anesthetic volume was     investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage,     volume was decreased by 0.5 for each nerves. Block administration time, block onset times,     anesthesia times and time to first analgesic requirement were recorded.   "
34233|NCT02837705|"     The human Prion diseases can be classified into sporadic, acquired and inherited forms.     Inherited forms usually manifest in higher age so there have to be factors preventing Prion     propagation in young mutation carriers. Antibodies against the flexible tail of Prions have     been shown to be protective in mice. The investigators intend to screen mutation carriers and     controls for the presence of Prion autoantibodies.   "
34234|NCT02837692|"     The purpose of this study is to assess the pharmacokinetics of single-dose evening     administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and     gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of     single-dose evening administration of JNJ-42847922 in healthy Japanese adults.   "
34254|NCT02837432|"     There is good evidence to suggest that the pathological version of sadness that people with     Major Depression experience could be caused by the failure of the hormone cortisol to     properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This     project investigates if the subgenual cingulate cortex has become insensitive to cortisol in     patients with depression and tests for variants of the cortisol receptor genes that could     predispose individuals to develop cortisol insensitivity.   "
34255|NCT02837419|"     This study evaluates patients on ECLS treatment as considered appropriate with mortality and     health related Quality of life and costs.   "
34235|NCT02837679|"     The study is a randomized study of patients living in four municipalities in Eastern Jutland.     After geriatric assessment half of the patients will be offered a tailor-made intervention in     their homes. The follow-up will last for at least 90 days and include treatment of the     patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The     other half of the patients, the results of the assessment and recommendations will be given     to the patients and their general practitioner.      The primary efficacy variables are accomplishment of planned cancer treatment, reduction of     complications and admissions to hospital and increased quality of life,.      If geriatric assessment and a tailor-made follow-up result in a better quality of life with     less complications and admissions the offer may be extended to a longer period, younger age     groups and other cancer diagnoses.   "
34236|NCT02837666|"     The purpose of this study is to demonstrate that Spirulina maxima intake and a dosed physical     activity program will decrease, both independently and synergistically, cardiovascular risks     (Dyslipidemias and oxidative stress) in overweight and obese subjects.   "
34237|NCT02837653|"     Objective: To determine the influence of a counseling of physical activity (PA) versus usual     care (UC) in the magnitude of chronic pain (CP) in patients diagnosed with chronic low back     pain (CLBP).      Methods: A total of 64 subjects with (CLBP) and older were randomly divided into two groups:     an experimental group (UC) + counseling of (AF) and control group (UC). Each group consisted     of 32 participants and were evaluated twice (pre and post-intervention), being spaced one     month, both groups received telephone follow-up for their participation. The primary endpoint     was the magnitude of the (CP) measured by the tool grading scale of chronic pain (EGDC),     while as secondary were considered the cardiovascular risk factors, catastrophism,     kinesiofobia, disabled by back pain, quality of life, anxiety and depression and the (FA).   "
34238|NCT02837640|"     The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis     pigmentosa.   "
34239|NCT02837627|"     Due to several promoting factors, gastro-esophageal reflux (GER) is very frequent in preterm     infants. To limit the potentially harmful widespread of pharmacological treatment, a     step-wise approach, which firstly undertakes conservative strategies, is currently considered     the best choice to manage GER in the preterm population. Among the most common conservative     strategies, postural measures seem to effectively reduce GER features in symptomatic preterm     babies, whereas feed thickening is almost ineffective.      Due to their prematurity, preterm infants <34 weeks gestation are often unable to coordinate     sucking, swallowing and breathing, thus requiring a feeding tube to ensure adequate enteral     intakes. Continuous feeding and boluses are the most common techniques of enteral tube     feeding in Neonatal Intensive Care Units; at present, however, the effects of these     techniques on GER features have not been clearly established.      This observational, prospective and explorative study primarily aims to evaluate the effect     of different techniques of enteral tube feeding on GER frequency and features in symptomatic     preterm infants (gestational age ≤33 weeks) undergoing a diagnostic combined pH and multiple     intraluminal impedance (pH-MII) for GER evaluation.   "
34240|NCT02837614|"     The study composed of sixty patients, each of whom required surgical extraction of a single     impacted mandibular third molar under local anaesthesia. The patients were randomly allocated     to one of 3 groups of 20 each. The three groups were categorized as Group A (intramuscular     dexamethasone), Group B (submucosal dexamethasone) and Group C (control). The objective     measurements of facial pain, swelling, and trismus was performed by an independent examiner     at baseline (preoperatively), and at days 1, 3, and 7 postoperatively.   "
34241|NCT02837601|"     A prospective, randomized, controlled single-center clinical Study designed to evaluate     Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS)     at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be     randomized in a 1:1 treatment device to control ratio into one of two (2) different study     arms:        1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or        2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.   "
34242|NCT02837588|"     -  Treatment at pelvic floor with hyperactivity with hyperthermy electrode MJS        -  MJS electrode is effective for transvaginal treatment at pelvic pain patients        -  Hyperthermy treatment with MJS electrode is more effective to usual drugs treatment   "
34243|NCT02837575|"     The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine     in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).   "
34244|NCT02837562|"     The goal of the present study is to evaluate the prevalence of radiation-associated lens     opacities among interventional cardiology staff members (such as physicians, technicians, and     nurses) and determine its association with occupational history.      The hypothesis of the study is that interventional cardiology staff will have high prevalence     of radiation-induced lens opacities, which will be higher than non-interventional cardiology     staff and will correlate with the estimated cumulative lifetime dose.   "
34245|NCT02837549|"     The purpose of this study is to determine the feasibility and preliminary effects of a novel     treatment approach to improve arm function in patients with scleroderma who have upper     extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed     at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual     sessions with an occupational therapist. Feasibility of the procedures is a major focus of     this project.   "
34246|NCT02837536|"     The goal of this study is to evaluate the agreement between intraocular pressure (IOP)     measurements taken by iCare, held in both vertical and horizontal positions. In addition,     iCare measurements will be compared against pneumotonometry measurements to assess for     accuracy.   "
34249|NCT02837497|"     Pediatric cardiac arrest affects thousands of hospitalized children each year. High quality     cardiopulmonary resuscitation (CPR) saves lives, but is difficult to achieve. The objective     of this study is to determine if a novel patient-centric resuscitation care improvement     bundle consisting of bedside CPR training and multidisciplinary reviews of each cardiac     arrest improves CPR quality and survival outcomes in a multi-center trial.   "
34250|NCT02837484|"     This study was designed to evaluate the long term effectiveness of a product used in knee     surgery called Affinity™ Membrane.   "
34256|NCT02837406|"     The aim is to evaluate a national health information technology-based program to improve     healthcare coordination and access to information.   "
34257|NCT02837393|"     The investigators objective is to determine if urinary electrolyte abnormalities exist in     only one or both kidneys in participants with and without a history of kidney stones. To meet     this objective, the investigators are going to take urine samples from each kidney at the     time of kidney stone surgery. The samples will then be analyzed for absolute and relative     differences in the concentrations of urine electrolytes, such as calcium.   "
34258|NCT02837380|"     This is an open-label study to evaluate the PK of FF/UMEC/VI in dose combinations of     100/62.5/25 mcg after single and repeat dose administration from a DPI in healthy Chinese     subjects. This study will evaluate the systemic pharmacokinetics (PK), of FF/UMEC/VI in     Chinese healthy population when administered using dry powder inhaler (DPI)as a blended     combination of UMEC/VI in one strip and FF in the second strip in dose combinations of     100/62.5/25 mcg. The triple, fixed dose combination product Fluticasone furoate(FF)/     Vilanterol (VI) /Umeclidinium bromide (UMEC) with new configuration enables the delivery of     inhaled long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA) and     inhaled corticosteroid (ICS) from a single device. Approximately 16 subjects will be enrolled     in the study. After taking into account the allowable time windows for screening, treatment     and follow-up, a subject will be in the study for a maximum duration of 6-7 weeks.   "
34259|NCT02837367|"     The NutriGen project will be using nutrigenomic methods to determine the effectiveness of     treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic     signature) of obese individuals.   "
34260|NCT02837354|"     The Cerebral Amyloid angiopathy (CAA) is the leading cause of cortical hemorrhage after 65     years. The presence of cerebral infarction is also reported anatomically in the AAC. MRI     studies of these infarcts are rare. They are described as punctate, cortical silent.     Frequency and pathophysiology is poorly understood. The investigators put the question of a     link with hemorrhagic lesions of the AAC.   "
34261|NCT02837341|"     Respiratory rate as an important predictor for adverse events, but still a neglected vital     sign.      Precise and simple measurement of the respiratory rate in volunteers by a new electronic     camera device in different settings.   "
34262|NCT02837328|"     The primary objective of this research is to determine whether oral magnesium supplementation     in healthy, community-living individuals will be associated with reductions in the burden of     arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).   "
34263|NCT02837315|"     The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session     (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and     drug-related consequences in college student   "
34264|NCT02837302|"     Protein-calorie malnutrition is frequently observed in patients with advanced liver     cirrhosis. There have been continued interests in potential benefits of long-term oral     branched-chain amino acid supplement in improving severity of liver disease. However, there     are limited evidences in literature. The aim of this study is to evaluate the efficacy of     oral branched-chain amino acid in patients with advanced liver cirrhosis.   "
34277|NCT02837133|"     Typically a course of yoga therapy for stress management takes place over a week, however,     investigators are often asked to provide a single session for workers. The aim of this study     is to assess the benefits of a single session of an integrated yoga program compared with     other relaxation techniques for the staff of schools.   "
34328|NCT02836457|"     The primary objectives of this study is to estimate the real-world safety profile of Eliquis     in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect     the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the     real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.   "
34420|NCT02835261|"     The overall goal of this project is to test the hypothesis that long-term, sustained sleep     restriction (SR), in women, will lead to increased cardio-metabolic risk. This will be     characterized by increases in visceral adiposity, unhealthy lifestyle behaviors (poor dietary     quality and low physical activity) and cardio-metabolic risk factors (blood pressure, glucose     intolerance) relative to habitual sleep (HS). The investigators expect these changes to be     worse in pre- compared to post-menopausal women.   "
34265|NCT02837289|"     Introduction: Hip motor control deficit and neuromuscular disorders of the gluteus medius     influence the mechanics of patellofemoral joints through increased dynamic knee valgus and     can lead to Patellofemoral Pain Syndrome (PFPS). Mechanoreceptors can be stimulated by an     elastic tape, which sends desired tactile cues via afferent improving the functional support     of the musculoskeletal system.      Objective: To analyze the response to hip stabilizer muscle activation in street runners with     PFPS through the application of elastic tape therapy.      Methods: The investigators evaluated street runners between the ages of 18 and 45, who run at     least 5km/week and had been suffering from pain for at least 3 months. The volunteers had     been assessed in relation to their measurements, experience of pain and training routine,     their medius muscle (GM) and biceps femoris muscle (BF) had also been tested with surface     electromyography through pre-determined performance tests. The participants of both groups     wore a bandage for 6 weeks (1 per week). However for the participants of the placebo group     the investigators applied a different anatomical path without tension, eliminating all the     therapeutic elements. The volunteers were reassessed following the trial.      Hypothesis: Expected to observe that elastic tape therapy do result in any improvement in the     activation of hip muscles and improvement of pain in street runners with patellofemoral pain     syndrome.   "
34266|NCT02837276|"     This pilot study aims at investigating the relationship between intermittent hypoxemia (IH)     and acute kidney injury (AKI) in preterm infants.      AIM 1: Test the hypothesis that intermittent hypoxemia is associated kidney injury in preterm     infants, as reflected by a rise in serum creatinine.      AIM 2: Test the hypothesis that there is rise in acute kidney injury urinary biomarkers with     increased intermittent hypoxemia.   "
34267|NCT02837263|"     The purpose of this research study is:        -  To find out how safe the study drug, pembrolizumab, is when combined with stereotactic          body radiotherapy (SBRT) to the liver.        -  To see how well subjects can tolerate treatment with pembrolizumab and SBRT.        -  To find out how often colorectal cancer comes back 1 year after surgically removing all          known disease and being treated with SBRT and pembrolizumab.   "
34268|NCT02837250|"     RECRUITING NOW AT www.pos4health.org      This project has developed a patient-centered eHealth intervention; specifically, an Internet     intervention, targeting multiple issues and nonadherence in HIV. The intervention,     Pos4Health, includes peer role model videos and evidence-based interactions to promote     understanding, coping with, and managing risk factors for nonadherence to ART, and to improve     nonadherence itself. In this Pilot Trial, investigators will test the eHealth intervention     Pos4Health with PLWH who reside outside urban centers.   "
34269|NCT02837237|"     This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney     Disease (CKD) (including patients with severe renal impairment and those on hemodialysis     [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of     KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular     filtration rate [eGFR] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification     of Diet in Renal Disease [MDRD] equation) and a subset of patients requiring HD.   "
34270|NCT02837224|"     Retained surgical items (e.g. sponges, needles, and instruments) remain the most frequently     reported serious adverse event for five of the last six years. Retained surgical sponges have     resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay,     infection, fistulas/ bowel obstructions, and death). The national standard for prevention of     retained surgical sponges relies heavily on manual counting several times before, during, and     after the surgical procedure. If a sponge is missing, a series of steps are taken to     reconcile the count. These steps require extra time and pull personnel away from other     competing priorities. If the final closing count remains incorrect, it is common practice to     obtain an intraoperative radiograph to rule out retention of a surgical sponge. This X-Ray is     expensive and increases the time required for the surgery.      Novel technology using a radiofrequency (RF) is now available for detecting and preventing     retained surgical sponges. The objective of this study is to evaluate the in-use     effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost     of searching for sponges and prevention of incorrect counts.   "
34271|NCT02837211|"     TREND is a pilot randomized trial comparing two alternative methods of initiating a     low-calorie weight loss diet. The study will compare the traditional diet initiation of     abruptly dropping energy intake to 1000 kcal/day for women and 1200 kcal/day for men versus a     6 week tapering of energy intake from a baseline level. These two approaches will be compared     with respect to their impact on energy regulatory systems of the body, weight loss and other     measures, up to a year after diet initiation.   "
34272|NCT02837198|"     To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of     FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or     uric acid-underexcretion type.      In addition, to investigate the additive effects of the combination of FYU-981 and     topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction     type.   "
34273|NCT02837185|"     This study will look into the effects of Botulinum Toxin in patients with primary cervical     dystonia. The effects will be determined by neck muscle activity measurements and brain     function activity measurements. The goal of the study is to try to identify markers of the     effects of Botulinum toxin.   "
34274|NCT02837172|"     This project will evaluate the utility of diffusion tensor imaging (DTI) as an adjunctive     method to improve early diagnosis of Parkinson's disease (PD). Two populations will be     evaluated in this study: 1) Individuals with uncertain PD diagnosis who receive a DaTscan,     and 2) individuals with well characterized PD and healthy controls, drawn from the fully     enrolled Parkinson's Progression Markers Initiative (PPMI) PD and control cohorts.   "
34275|NCT02837159|"     The purpose of this randomized study is to assess the efficacy of a mobile application for     the promotion of healthy lifestyle habits (diet and exercise) in colorectal cancer survivors     (CCR).   "
34276|NCT02837146|"     This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive     very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and methotrexate     (MTX).   "
34322|NCT02836535|"     The purpose of this study is to understand the patient experience with an adverse event after     surgery. An adverse event is an undesirable experience or complication associated with your     surgery.   "
34278|NCT02837120|"     Acute non-traumatic chest pain is a common kind of symptom in extremely critical condition,     with various pathogenesis and different level of risk . Chest pain in high risk takes 1/3 of     that. It mainly includes acute coronary syndrome (including myocardial infarction and     unstable angina pectoris, accounted for over 95% of chest pain in high risk), aortic     dissection, pulmonary embolism etc, and is in high lethality and deformity.      The investigators do the research :        1. To study the diagnosis and management condition of acute chest pain in extremely          critical condition for last ten or more years in Qilu Hospital,Shandong University.        2. To discuss the significance of key accompanying symptoms(for example radiating pain,          chest distress, sweating, nausea etc), physical signs and lab examination in early          diagnosis and risk stratification of acute chest pain in extremely critical condition.        3. To study the effect factors of thrombus burden in STEMI patients, at the same time,          creat a a simple, practical and scientific method of blood clots classification.   "
34286|NCT02837016|"     The investigators propose a randomized controlled trial (RCT) to investigate the feasibility     and efficacy of non-intrusive biofeedback devices that can be worn throughout the day in     providing therapeutic cues to college students suffering from chronic anxiety. The     biofeedback device detects physiological stress indices in real time (e.g., changes in     breathing rate) and provides feedback (e.g., through minor vibration or text messages)     serving as a cue to the wearer to recall therapeutic steps at exactly those moments they need     to exert cognitive control. Students will be randomized in a 1) experimental group with     biofeedback device and 2) experimental group without biofeedback device. Experimental groups     will undergo an intervention that will strengthening cognitive control through     mindfulness-based relaxation techniques. Outcome measures will include a multi-method     approach collecting questionnaire, behavioral, neuro-scientific, and psycho-physiological     indices of anxiety and self-control. The proposed study is innovative and has the potential     to lead to more effective and cost-efficient types of intervention applications in the     future.   "
34279|NCT02837107|"     While it is well accepted that a low level of RONS production is necessary to maintain     physiological function, too much formation of RONS are believed to participate in     biomolecules damage. Damage of lipids, proteins and DNA/RNA, to cellular and tissue level, as     a consequence of oxidative stress has been linked to a number of serious diseases, including     cancer, cardiovascular diseases (CVDs) such as hypertension and atherosclerosis,     neurodegenerative diseases such as Parkinson's disease and Alzheimer's dementias, diabetes     and the process of aging.      The dietary intake of antioxidants is thought to play a major role in oxidative stress     network. Many epidemiologic studies have reported an inverse association between vegetable     and fruit consumption with reduced risk of chronic diseases, especially cancer and CVDs.     However, although many clinical trials have been conducted with vitamins (E, C or their     combinations) their in vivo protective effect remains uncertain. Therefore the possibility     that the complex mixture of phytochemicals in foods may contribute to their protecting     effects has been raised. In this concept, it is possible multiple compounds to act through     complimentary or synergistic mechanisms to present a greater biologic effect than can be     achieved by any individual component To investigate this hypothesis, a double-blind,     randomized, and placebo-controlled clinical trial was conducted in order to investigate the     effects of a multi-micronutrient supplement against oxidative stress in apparently healthy     adults.   "
34280|NCT02837094|"     The study is a two centre, open-label, uncontrolled single group phase 1A study of C19-A3 GNP     peptide (10 μg peptide equivalent content) administered via Nanopass microneedles every 28     days for 8 weeks (3 doses), with follow-up for 6 weeks (14 weeks in total from first dose).     Treatment will be given into the arm at a volume of 50ul.      No blinding or randomisation will be performed. In keeping with standard phase 1 study     designs, no placebo or control group is included as the primary aim is to establish whether     there are any major unexpected safety issues in the use of this IMP for the first time in     man. 8 subjects will be recruited at 2 centres: Cardiff, UK and Linköping, Sweden.   "
34281|NCT02837081|"     Antimicrobial stewardship program (ASP) is recommended to improve appropriate antimicrobial     use, reduce bacterial resistance, unnecessary drug costs and enhance patient health outcomes.     Two core strategies of ASP recommended as effective in guidelines are formulary restriction     with drug preauthorization and prospective audit with feedback. Investigators will evaluate     the effectiveness of the 2 strategies using antimicrobial utilization and patient outcomes.   "
34282|NCT02837068|"     The purpose of this study is to determine whether wheelchair handrail compensator plus     rehabilitation training could do better than ordinary wheelchair plus rehabilitation training     in relieving pain and improving daily life activity, upper limb motor function and quality of     life for patients with hemiplegic shoulder pain.   "
34283|NCT02837055|"     It has been shown that videolaryngoscopy may be superior to direct laryngoscopy for     endotracheal intubation in intensive care. Recently, an endotracheal tube with an integrated     camera at its tip has been introduced (VivaSight-SL) allowing for direct visual confirmation     of the tube's passage through the vocal cords during intubation.      Patients who are requiring urgent or endotracheal intubation in intensive care are randomized     to receive either a conventional intubation with direct laryngoscopy or to receive intubation     with the VivaSight-SL-Tube. Primary outcome measures are first attempt success rate and     number of attempts to successful intubation.   "
34284|NCT02837042|"     Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in     less developed countries. PSCC is a highly aggressive malignancy characterized by early     spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will     serve as the investigational agent for this penile cancer study.   "
34285|NCT02837029|"     The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest     dose of the study drug nivolumab that does not cause unacceptable side effects, for     combination treatment of nivolumab and yttrium Y 90 glass microspheres (Y-90). Also, to     evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of     the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere).     Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has     not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab is an     antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to     allow the body's immune system to work against tumor cells. Y-90 is currently FDA approved     for the treatment of hepatocellular carcinomas, but has not yet been investigated in     combination with nivolumab for this disease.   "
34323|NCT02836522|"     The purpose of this study is to finalize development of a questionnaire that measures     health-related symptoms and concerns for persons diagnosed with, and either treated or     monitored for, anal pre-cancer lesions.   "
34324|NCT02836509|"     Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for     the pain treatments.      The objective of the study was to assess whether intravenous Paracetamol has superior Low     Back Pain reduction will compare with Ibuprofen in emergency department (ED) adults.      Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.   "
34361|NCT02836028|"     The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of     talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and     safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed     ovarian, fallopian tube, and peritoneal cancer.   "
34287|NCT02837003|"     To evaluate safety of reduction of dual antiplatelet therapy period to three months after     implantation of Ultimaster sirolimus-eluting stent (U-SES).      Additionally to investigate appropriateness of thienopyridine monotherapy with     discontinuation of aspirin.   "
34288|NCT02836990|"     This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision     Management System versus Dermabond in preventing groin wound infections in patients who     undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond     and the other half will receive the Prevena Incision Management System for their groin     wounds.   "
34289|NCT02836977|"     Primary Objective:      To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant     oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in     patients with stage III colon cancer after radical resection.      Secondary Objectives:        -  To assess 5-year overall survival (OS) in each arm        -  To assess the safety profiles   "
34294|NCT02836912|"     Pulmonary rehabilitation exercise is beneficial for individuals with chronic obstructive     pulmonary disease (COPD). However, merely 30% patients know how to do the exercise correctly.     Therefore, it is worthy to investigate the applications in clinical practice. In addition,     there are no relative research in Taiwan to see effects of an 8-week pulmonary rehabilitation     exercise in home care for the non-invasive ventilator-dependent elderly with COPD.   "
34295|NCT02836899|"     The purpose of this study is to determine whether nitric oxide is effective in the treatment     of acute kidney injury in cardiac surgical patients with endothelial dysfunction undergoing     prolonged cardiopulmonary bypass.   "
34296|NCT02836886|"     This study will be using this technique, called VirCapSeq-VERT to analyze the white blood     cells of patients with Sézary syndrome. This could provide the foundation for future studies     looking to understand the role that viruses play in the origin of Sézary syndrome. This could     have important implications for the future development of new and effective therapies for the     disease.   "
34297|NCT02836873|"     The purpose of this study is to investigate the effect of bexagliflozin in lowering     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and moderate     renal impairment.   "
34298|NCT02836860|"     The purpose of this study is to compare combined tactile stimulation and verbal instruction     to verbal instruction only on lumbar multifidus muscle activation in asymptomatic healthy     adults and in patients with LBP.   "
34299|NCT02836847|"     The purpose of this study is to evaluate the feasibility, efficacy and safety of target     therapy according to genomic and proteomic profiling combined with GEMOX in advanced or     recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.   "
34300|NCT02836834|"     The primary objective is to assess the safety and tolerability of JS-001 in subjects with     various advanced or recurrent malignancies, including solid tumors and lymphomas, and to     evaluate its preliminary efficacy.      The secondary objectives are to: 1) characterize the single-dose and multi-dose     pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3)     assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate     biomarkers associated with the efficacy of JS-001.      The exploratory objectives include to evaluate the consistency between biomarker detection     results of archived tissue and fresh frozen tissue, and to assess the consistency of response     using various response criteria (such as irRC, WHO, RECIST and irRECIST).   "
34301|NCT02836821|"     The primary purpose of this study is to investigate potential pharmacokinetic interaction in     healthy volunteers when apatinib is administered in combination with rifampicin. Secondary     objective is evaluating the safety and tolerability of apatinib alone and when     co-administered with rifampicin.   "
34421|NCT02835248|"     Medical alert devices with automatic fall detection functionality use accelerometry to detect     a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the     alert button. This can save lives and prevent complications associated with long periods of     time spent on the floor after a fall. In this project, the sensitivity and false alarm rate     of a commercially available medical alert device will be tested in a population of 200     community-dwelling older adults.   "
34302|NCT02836808|"     Abstract: Empowerment interventions for chronic diseases are an evolving process. No     agreement exists regarding the necessary components and methodologies to be applied.     Systematic reviews have assessed the effect of self-management interventions. Improvements in     illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In the     long term, no major changes have been achieved in weight, physical activity, smoking status,     and depression scores.      There is a need for additional studies. The Center for Comprehensive Care of Patients with     Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment     techniques (using simple low-cost interactive tools) over a short period of time followed by     at-distance support using internet or cell phone technology. The target population consists     of patients with type 2 diabetes, free of chronic complications who are non-smokers. The     intervention is composed of four monthly visits followed by a continuous at-distance support     system. At each visit, patients stay for six hours in the center. Information is presented in     group sessions. Empowerment techniques are applied during individual exchanges with the team     or during facilitated group sessions. In summary, empowerment programs are an unmet need in     many healthcare services.   "
34303|NCT02836795|"     This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody     JS001, as a monotherapy in patients with advanced melanoma or urological cancers who have     failed in routine systemic treatment. The study will be conducted in 2 parts: dose escalation     and cohort expansion to investigate tolerability and efficacy.   "
34304|NCT02836782|"     New markers of viral activity are now under investigation. Aim of the study is to investigate     the efficacy of new antiretroviral drugs by monitoring HIV-DNA dynamics in HIV-positive     population. In HIV/HCV coinfected population, the study of HIV reservoir dynamics and the     analysis of the prevalence of HCV resistance-associated mutations will help clinicians to     improve the management of coinfected patients.   "
34305|NCT02836769|"     Although evidence exists to support cancer rehabilitation, services are fragmented and     rehabilitation professionals are consulted infrequently and often long after treatment ends,     when chronicity of problems limits the impact of intervention. Therefore, the objective of     this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation     Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and     resources to meet those needs; to establish individualized rehabilitation goals for HNC     survivors and personalized action plans to meet those goals; and to provide support to HNC     survivors for the implementation and evaluation of action plans. This project consisted of     intervention development and pilot evaluation; this trial registration describes the pilot     evaluation phase only.   "
34306|NCT02836743|"     To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.   "
34430|NCT02835118|"     This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses     of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and     females.   "
34431|NCT02835105|"     This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single     oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males     and females.   "
34307|NCT02836730|"     The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar     disc herniation and 60-70% in patients with spinal stenosis.      At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc     herniation and spinal stenosis are treated by a multidisciplinary team comprising     rheumatologists, physiotherapists, chiropractors, and social workers according to current     guidelines. Therefore we have a unique opportunity to report the long term outcome in     candidates for surgery, regardless of whether they have surgery or not, after having received     optimal but unsuccessful nonsurgical treatment.      The purpose of this study is to answer the following questions: 1) What is the proportion of     patients operated upon after referral to surgical evaluation with positive MRI findings,     persistent low back pain, and poor outcome following non-operative treatment? 2) What was the     outcome in these patients 2 years following referral? 3) Where any baseline variables     predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in     patients with or without surgery?   "
34308|NCT02836717|"     The aim of this study is to determine the success rate, the success duration, the     complication rate, maintenance effort and quality of life several years after sacral nerve     modulation (SNM) treatment for constipation or stool incontinence.   "
34309|NCT02836704|"     Primary Objective:      -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior     to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one     episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in     overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs     (OADs).      Secondary Objective:        -  To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.        -  To evaluate the percentage and accumulated percentage of patients achieving fasting          plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).        -  To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).        -  To evaluate the insulin doses change.        -  To evaluate the weight change.        -  To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia          occurrence.        -  To descriptively evaluate the safety profile.        -  To assess patient and physician satisfaction and adherence (drop-out rate and the          percentage of patients who can follow the treatment and insulin titration).        -  Subgroup analysis on efficacy (control rate, control rate without confirmed          hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:        -  Age        -  Duration of diabetes        -  Baseline treatment (OAD)        -  Baseline HbA1c, FPG and PP   "
34326|NCT02836483|"     A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II     Trial of LCB01-0371.   "
34310|NCT02836691|"     The autonomic nervous system (ANS) plays an important role in asthma, primarily through the     parasympathetic (by the cholinergic pathway) promoting bronchoconstriction. Asthma is a     chronic inflammatory disease, however, bronchoconstriction is not always caused by bronchial     inflammation, as occurs in paucigranulocitic phenotype or noninflammatory asthma. The     hypothesis of this project is based on the activation of the parasympathetic nervous system     (PNS) would be involved in the pathogenesis of noninflammatory asthma (paucigranulocitic     phenotype) and emotional stress and poor control of patients with severe asthma. To determine     the ANS involvement in the pathogenesis of paucigranulocItic phenotype in asthma and     correlate emotional stress, mediated by the ANS, with uncontrolled severe asthma. 30     asthmatics with different clinical severity (mild, severe controlled and uncontrolled severe)     will be recruited , along with a control group of 10 healthy people. Descriptive variables,     spirometry, inflammatory parameters (FeNO and inflammatory cell count in induced sputum),     blood, saliva, urine and hair to obtain stress markers (glucose, copeptin, prolactin,     cortisol) will be collected, and be supplied validated questionnaires of asthma control,     quality of life and stress. For monitoring the response of the ANS will be done through an     electrocardiogram, recording the heart rate variability (HRV). This analysis is carried out     with the collaboration of engineers specialized in the characterization of cardiovascular     signals for measuring the ANS.   "
34311|NCT02836678|"     The effect of adding Nanobone on horizontal bone gain in ridge splitting.   "
34312|NCT02836665|"     After admission to the emergency room each dermatological patient is routinely assessed to     Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis     followed by randomization in two equal study groups.      Patients of group A (control group) wait routinely until the dermatological investigator in     charge arrives at the emergency room. Once the dermatological investigator is on site, he     gives a diagnosis and proposes a therapy.      For Patients of group B (teledermatology) study-related photographs of the skin lesion and     anamnesis data are uploaded to the hospital information system medico. Those data can     directly be processed by the dermatological investigator in charge who enters his diagnosis     and his therapy proposal.      Subsequently an internal control is carried out as the same investigator comes personally to     the emergency room to check its telemedical diagnosis and therapy proposal.      Finally both time periods patients have to wait in the emergency room for their diagnosis and     therapy are compared with each other.   "
34313|NCT02836652|"     This study is a prospective, multi-center, randomized, double-blind placebo-controlled study     of subjects receiving the HM II LVAD as per the current FDA approved indications for use.   "
34314|NCT02836639|"     Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan)     conditioning regimen for ASCT in non-Hodgkin's lymphoma   "
34334|NCT02836379|"     In the context of radiotherapy, control of breakthrough pain represents a special challenge.     Patients undergoing radiotherapy may experience different situations of pain that may be due     to the need to remain immobilized during radiotherapy session, the need to wear an     immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation     after the development of proctitis, or sudden pain during the night causing sleep     disturbances.      In a survey conducted in radiation oncology services more than half of patients treated with     radiotherapy experienced pain, and 39% of patients reported that their pain was not treated     properly. This situation may increase the patient's anxiety, dissatisfaction with treatment,     affect their quality of life and can even come to refuse radiotherapy treatment.      This post-authorization observational study will assess the quality of life of cancer     patients with breakthrough cancer pain treated in radiotherapy services in Spanish hospitals.   "
34315|NCT02836626|"     Over 1.37 million Caesarian sections (C-sections) are performed annually in the US . It is     estimated that 12-20 % of those will result in chronic scar pain. This pain can lead to     functional difficulties performing activities of daily living, pain with bowel movements, and     pain with sexual activity . There is anecdotal evidence supporting the use of deep fascial     scar mobilization techniques in reducing abdominal surgical scar pain, and yet almost no     research has been published. The aims of this randomized clinical trial will be to determine     if deep fascial scar mobilization techniques or superficial scar mobilization techniques will     improve chronic pain and its resulting functional deficits, threshold pressure discomfort,     pressure tolerance and mobility restrictions resulting from C-section surgery and to see if     these interventions are more effective than no intervention. A positive result may result in     an increase in the use of this intervention and thus the reduction of chronic scar pain for     many women; it may provide justification for insurance reimbursement for this approach and it     will also pave the way for further investigation into the use of these techniques with other     types of painful scars including hysterectomy.   "
34316|NCT02836613|"     The main purpose of this study is to evaluate how much galcanezumab gets into the body after     it is given as an injection just under the skin by two different devices. This study will     measure how much galcanezumab reaches the blood stream and will test how it affects     calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may     occur will be collected. The study will last about 20 weeks for each participant. Screening     is required within 45 days prior to the start of the study.   "
34317|NCT02836600|"     The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in     Japanese participants with advanced solid tumors.   "
34318|NCT02836587|"     Fall related injuries are major health problem which effect especially elderly population.     After experiencing a fall, most of the elderly are unable to resume their previous mobility     and the fear of future falls affects their daily life. Falls in elderly population are often     related to balance or gait problems. The aim of this study is to assess the influence of     balance training on postural and motor control of healthy elderly participants. The study is     designed as a parallel interventional study with experimental and control group (allocation     ratio 1:1). Participants' general health, balance abilities, fear of falling and gait     stability and variability will be assessed on the baseline measurement, right after and 2     months after the completion of the training programme. Experimental group will undergo     training focused on development of balance abilities and strength twice a week (60 minutes in     length each) for 8 weeks. Participants will receive individualized exercises which will be     focused on the main 4 types - stance exercises, gait and transition exercises and strength     exercises especially focused on muscle strength of lower extremities.   "
34319|NCT02836574|"     The purpose of the present study is to compare the safety and efficacy of up to 2 injections     of NKA given 3 to 6 months apart (maximum) in subjects who are randomized to receive their     first treatment as soon as the NKA product is made available versus subjects who are     randomized to undergo contemporaneous, standard-of-care treatment for CKD during the first 12     18 months prior to receiving up to 2 injections of NKA.   "
34320|NCT02836561|"     The goal of this project is to investigate whether a pre-visit telephone intervention could     increase awareness of long-acting reversible contraception (LARC) availability at the time of     uterine evacuation.   "
34321|NCT02836548|"     This is a mono-center open-label proof-of-concept pharmacologic study to explore the efficacy     and safety of vorinostat in advanced BRAF mutated melanoma, which became resistant for     BRAF-inhibitors or the combination of BRAF- and MEK-inhibitors.   "
34329|NCT02836444|"     Current definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for     epidemiological studies but are not adequate for inclusion of patients into therapeutic     clinical trials. It is a matter of debate whether the assessment of hypoxemia at ARDS onset     is appropriate for stratifying lung severity and risk of death in ARDS patients. The     investigators will perform an observational, non-interventional, multicenter, prospective     audit in a network of intensive care units in Spain for evaluating the severity and risk of     death based on the assessment of respiratory and ventilatory function at 24 hours after ARDS     diagnosis under standardized ventilatory conditions. This study is the confirmatory phase of     the study NCT02288949.   "
34330|NCT02836431|"     This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the     blood when given by nasal spray. The study will help us determine the best dosing amount for     children undergoing sedation or anesthesia with DEX.   "
34331|NCT02836418|"     ATYR1940-C-006 is a multi-national, multicenter study being conducted at centers in the     United States (US) and Europe who participated in the Study ATYR1940-C-003 (Stage 1 only) or     ATYR1940-C-004 (i.e., the parent studies).   "
34332|NCT02836405|"     The main purpose is to study brain plasticity (the changes that occur in the brain through     experience) in individuals with autism spectrum disorder (ASD). Research suggests that during     development, the brains of individuals with ASD may change in response to their experiences     differently than the brains of typically developing individuals. Investigators want to     understand why and how this difference may contribute to the symptoms of ASD.   "
34333|NCT02836392|"     This is a translational, multicentre questionnaire study. The study design follows that of a     cross sectional, quantitative research approach. Data collection will involve     self-administered, paper-based questionnaires. The method of data collection allows for a     large sample size without major expense. The questionnaires are comprised of several     questions examining areas such as demographic details, cancer diagnosis, understanding of the     term 'clinical trials', attitudes to personal participation in cancer clinical research and     the experience of patients who previously participated in a cancer clinical trial. The study     will be opened in all interested hospitals in Ireland following initiation of the study at     each site. Questionnaire completion will be seen as implied informed consent and no formal     consent will need to be signed by the patient. The paper-based questionnaire responses will     be electronically and anonymously recorded in a computer database to facilitate analysis.   "
34432|NCT02835092|"     The study evaluates the effects of two commercially available weight loss programs, the TSFL     and the MEDD programs, each compared to a self-directed control diet, on changes in body     weight over a 16-week weight loss phase, in apparently healthy overweight and obese men and     women.   "
34335|NCT02836366|"     With this study results of the Targon® PH+ nail, developed for the treatment of humeral head     fractures, will be investigated clinically, radiological evaluation is optional. The primary     objective of this study is to examine the effect of a plating treatment on the speed of     recovery of functional capacity in adult patients. Secondary aims are to examine the level of     pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and     complications.      Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by     Aesculap   "
34336|NCT02836353|"     Surgery on the gastrointestinal (GI) tract results in profound changes to the metabolic     profile. This is well described, including the rapid resolution of diabetes seen after     bariatric surgery. The underlying pathophysiology, and incidence in lean patients undergoing     surgery for cancer, is somewhat less described. The investigators plan to assess the     symptomatic and glycaemic profile, as well as causative pathways, for metabolic symptoms in     patients after surgery on the GI tract. The investigators will use glucose tolerance tests,     physiological challenges with somatostatin analogues and antibiotics, and assess tissue     transcriptomic changes.   "
34337|NCT02836340|"     Following successful cardiopulmonary resuscitation (CPR) after out of hospital cardiac arrest     (OHCA), 50% of patients admitted to the Intensive Care Unit (ICU) die. As most patients die     due to brain damage sustained during cardiac arrest and the subsequent reperfusion phase,     effective neuroprotective strategies could potentially improve outcome. In animal     experiments, 2-Iminobiotin (2-IB), a selective neuronal and inducible nitric oxide synthase     (NOS) inhibitor, given upon reperfusion has been shown to improve memory function. Since 2-IB     has not shown any safety issues in preclinical and clinical studies. Before embarking on     large studies with efficacy as primary endpoint, safety, tolerability and pharmacokinetics     need to be established.      Objective: Evaluate short term safety and tolerability, and the pharmacokinetic properties of     2-IB in adult patients after OHCA.      Study design: Phase 2, single-centre, open-label, dose-escalation intervention study.      Study population: Three cohorts of eight evaluable patients admitted to the ICU after OHCA     due to a cardiac cause.      Intervention:      The first eight patients will receive 0,055 mg/kg 2-IB every 4 hours intravenously, 6 times     in total (part A). The second eight patients (cohort B) will receive 0,165 mg/kg every 4h iv,     6 times in total. The third eight patients (cohort C) will receive 0,5 mg/kg every 4h iv, 6     times in total. Medication has to be given as soon as possible and within 6h after OHCA.     Escalation to the next dose level will only be done after pharmacokinetic analyses have     performed, no relevant safety issues have been encountered, and the DSMB approves to move to     the next dose level.      Main study parameters/endpoints:      Study parameters to evaluate short term safety and tolerability will be vital signs (heart     frequency, blood pressure, cardiac ischemia) before and until 15 minutes after     administration. (Serious) Adverse Events will be recorded on the ICU (up to 7 days) or until     discharge from the ICU. For evaluation of the pharmacokinetics profile of 2-IB, 9 plasma     samples will be analysed. Secondary parameters: Biochemical markers Neuron specific Enolase     and s100b at 24h and 48h after start of study drug, occurrence of SAEs until 30 days after     OHCA including death, long term term efficacy as determined by the Cerebral Performance     Category (CPC), the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) or     the Telephone Interview Cognitive Status (TICS) scale at 30 days after OHCA.   "
34422|NCT02835235|"     This trial is conducted in the United States of America. The aim of the trial is to     investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and     Female Subjects being overweight or with obesity   "
39603|NCT02767258|"     Clinical trial for prevention, randomized controlled, parallel, double-blind, with three     arms, which purpose is verify the nursing interventions (artificial tear gel and liquid     artificial tears)effects to prevent dry eye in adult patients admitted in ICU.   "
34338|NCT02836327|"     To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and     neuromyelitis optica spectrum disorders.      The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white     matter fiber tracts destruction , iron deposition and cerebral blood flow of associated     regions in multiple sclerosis and neuromyelitis optica spectrum disorders using     contrast-enhanced magnetic resonance imaging , quantitative susceptibility mapping, diffusion     tension imaging, and arterial spin labeling with post labeling delay of 2.0 seconds. Transfer     constant volume , magnetic susceptibility, cerebral blood flow and fractional anisotropy(FA)     value were measured in lesion and normal appearing white matter.   "
34339|NCT02836314|"     The aim of this split mouth, single-center, controlled study is to compare the healing of     intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet     Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the     study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.   "
34340|NCT02836301|"     Investigators will evaluate organ donation educational videos with a 2x3 single blinded     Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs).     The testimonial video about Uncontrolled Donation after Circulatory Determination of Death     (uDCDD) with an uplifting ending will serve as control. Experimental videos may include live     uDCDD footage, differing endings, or combinations. Video production will be informed by the     entertainment education model and produced with experts including an Academy Award winning     filmmaker. The primary outcome is whether participants immediately enroll in the NY State     Organ Donor Registry (either online or by our RA mailing in the official form with prepaid     postage). Investigators hypothesize that each video will induce differences in registration     compared to the control and that there is an interaction effect with video genre and story     outcome.   "
34341|NCT02836288|"     The primary purpose of this study is to see if it is safe to give patients with cancer a low     dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation,     chemotherapy, and/or surgery for their cancer treatment to treat depression and its effects.     Researchers would also like to see if giving ketamine at the same time as cancer treatment is     practical and reasonably acceptable to the patient.      Depression has many negative consequences for outcomes in those with cancer. It causes     delayed treatments, increases in hospital lengths of stay, decreases in treatment adherence,     poorer self-care, and decreased quality of life, even at 3 years post treatment. The presence     of depression is the number one predictor of incomplete treatment and difficulty with     rehabilitation. Therefore, investigators would also like to see if it is feasible to give     patients ketamine during their routine cancer treatment treat depression and its negative     effects on cancer treatment outcomes, and also help with anxiety, pain, and quality of life.     The study will also use a placebo to compare to the good and/or bad effects of ketamine. A     placebo is not an active drug and it will be look the same as ketamine, as a liquid to be     taken by mouth.      Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic     by itself for some diagnostic and surgical procedures or combined with other general     anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered     experimental in this study because it is not approved by the FDA for the treatment of     depression.   "
34342|NCT02836275|"     Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian     tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules' to     classify an ovarian tumor as benign or malignant. In about 1/5 of patients the Simple Rules     give an inconclusive result and therefore a suitable second line test is necessary. Recently     the ADNEXMR SCORING system was developed, this is the first Magnetic Resonance Imaging (MRI)     score system that focuses on ovarian tumors.      The aim of this prospective study is to evaluate the performance of pelvic MRI examination     with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING     system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the     prediction of malignancy). Other aims are the determination of the malignancy rate per     ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the     assessment of the accuracy of the specific diagnosis based on MRI images.      The study is a multicenter prospective study. In centers where perfusion -and diffusion     weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based     on ultrasound, the study is considered to be interventional. However, in other centres,     depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be     standard of care. In these centres, the study can be considered to be observational.      The IOTA-MRI project is linked to the IOTA study. In this multicenter study different     diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass     prior to surgery. This study allows to define a subgroup of patients in which Simple Rules     are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI     project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included     consecutively, yet only after completing the informed consent. Recruitment will take 2 years     of time as of the start of the individual center.      The gold standard is the histopathology diagnosis of the mass within 120 days after     ultrasound evaluation. The surgical approach is chosen by the managing clinician.   "
34343|NCT02836262|"     To evaluate effectiveness and safety of HHRS in subjects undergoing total hip arthroplasty     (THA). Effectiveness will be evaluated using patient-reported, clinical, radiologic, and     radiostereometric outcomes. Safety will be evaluated through the collection of device-related     and unanticipated device-related adverse events.   "
34344|NCT02836249|"     The primary objective of this study is to compare the efficacy, safety, and tolerability of     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and     treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B     virus (HBV) infection in China.   "
34345|NCT02836236|"     The primary objective of this study is to compare the efficacy, safety, and tolerability of     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and     treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B     virus (HBV) infection in China.   "
34346|NCT02836223|"     This study evaluates the addition of an interdental cleaning device paired with a manual     toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival     bleeding and reduction of gingival inflammation.   "
34347|NCT02836210|"     To prospectively compare clinical outcomes using straight (perpendicular) versus angled     trocar insertion during 27 gauge pars plana vitrectomy surgery for epiretinal membrane      Primary Endpoints:      Sclerotomy suture rates and incidence of suture blebs at the end of 27 gauge MIVS.      Secondary Endpoints:      Rate of postoperative wound-related complications such as hypotony, choroidal detachments,     endophthalmitis, and sclerotomy-related retinal tears with a minimum follow-up of 30 days.   "
34479|NCT02834481|"     The main objective is to assess correlation between ANI/NIPE values and external evaluation     COMFORT B scale during painful medical cares and during said comfort medical cares in     intubated children admitted in pediatric intensive care unit postoperative of cardiac surgery     with extracorporeal circulation.   "
34348|NCT02836197|"     Background: Although previous studies have reported the efficacy of communication skills     training programs (CST), specific training addressing communication about uncertainty and     hope in oncology has not yet been studied. This paper describes the study protocol of a     randomized controlled trial assessing the efficacy of a CST program aimed at improving     physician ability to communicate about uncertainty and hope in encounters with cancer     patients.      Methods: Physician participants will be randomly assigned in groups (n = 3/group) to a     30-hour CST program (experimental group) or to a waiting list (control group). The training     program will include learner-centered, skills-focused, practice-oriented techniques. Training     efficacy is assessed in the context of an encounter with a simulated advanced stage cancer     patient at baseline and after the CST for the experimental group, and after four months for     the waiting-list group. Efficacy assessments will include communicational, psychological and     physiological measures. Group-by-time effects will be analyzed using a generalized estimating     equation (GEE). A power analysis indicated that a sample size of 60 (30 experimental and 30     control) participants will be sufficient to detect effects.      Discussion: The current study will aid in the development of effective CST programs to     improve physician ability to communicate about uncertainty and hope in encounters with cancer     patients.   "
34349|NCT02836184|"     With calcium carbonate as the positive control drug, to observe the effectiveness and safety     of nicotinic acid in hemodialysis patients with hyperphosphatemia   "
34350|NCT02836171|"     he primary purpose of this study is to investigate potential pharmacokinetic interaction in     healthy volunteers when apatinib is administered in combination with itraconazole. Secondary     objective is evaluating the safety and tolerability of apatinib alone and when     co-administered with itraconazole.   "
34351|NCT02836158|"     This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high     effective in elderly patients with primary central nervous system lymphoma (PCNSL).   "
34367|NCT02835950|"     The objective of this study is to assess the safety, performance and initial effectiveness of     the TIVUS™ System when used for pulmonary artery denervation through subjective and objective     change in clinical parameters and haemodynamic evaluation. This is a prospective,     multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to     4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who     have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific     medications.   "
34368|NCT02835937|"     Do ambulatory RBC transfusions improve home functional status?   "
34369|NCT02835924|"     The purpose of this study is to assess the safety and tolerability of different     dose-escalation approaches of regorafenib in mCRC patients.   "
34370|NCT02835911|"     This registry study is intended to establish a large prospective longitudinal clinical cohort     of lymphoma patients in Malawi, as such data is currently lacking from sub-Saharan Africa.     The investigators will perform core biopsies on at least 800 consecutively enrolled patients     with suspected lymphoma for accurate histopathologic characterization. The investigators will     systematically collect relevant clinical and laboratory data, and longitudinally follow those     with confirmed hematologic malignancies receiving treatment according to local standards of     care to assess outcomes.   "
34352|NCT02836145|"     Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged     women that frequently cause urogenital infection, voiding difficulty, urinary retention,     pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of     women. Risk factors of the above diseases include pregnancy, vaginal delivery, and menopausal     status. Despite playing a crucial role in the pathophysiology of the above diseases, the     urogenital skeletal muscular dysfunction cannot be fully corrected via the current treatment     modalities.      The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for     current research and future cell therapy because of their significant self-renewal,     differentiation potential and the relative lack of ethical conflict. With the advent of     efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into hiPSCs,     researchers can generate personalized lines of cells from which it will be possible to obtain     differentiated cells in a less invasive way, introducing opportunities in treating diseases     that are now considered incurable.      Until very recently, little success has been achieved in terms of skeletal muscle     differentiation from hiPSCs. The purpose of this study is to explore the applicability of the     differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the     associated biomolecular messages. It is anticipated that the derived skeletal muscle     progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence     and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital     problems.   "
34353|NCT02836132|"     The aim of this Phase II Small Business Technology Transfer grant is to complete development     of a virtual reality intervention to augment and improve commercial Internet-delivered     behavioral weight loss treatments, and to test it in a randomized controlled trial.   "
34354|NCT02836119|"     The overarching study aim is to evaluate the development of sleep behavior and gut microbiota     (GMB), and their potential interaction, during the vulnerable period of the first year of     life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight     into the functional coevolution of the GMB and host sleep behavior.   "
34355|NCT02836106|"     The aim of this project is to elucidate how high-fat meals with different kinds of dairy     products affect postprandial responses of lipid metabolism and inflammatory markers in     healthy and obese subjects.   "
34356|NCT02836093|"     Many patients receiving radiation therapy for breast cancer experience fatigue although     doctors do not fully understand why. The purpose of this study is to test if patients who     experience fatigue during radiation treatment for breast cancer have changes in their     capability to perform exercise on a treadmill.   "
34357|NCT02836080|"     Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%,     yet youth are challenged to access services in a timely fashion. To address MHA system gaps,     this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for     at-risk youth with MHA challenges. In partnership with community agencies, adolescent     psychiatry hospital departments, and family health teams, investigators have developed an     innovative model of service provision involving rapid access to MHA services. This model will     be implemented and compared to the usual treatment youth receive in hospital-based,     outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services     geared to need in a youth-friendly environment is expected to result in better MHA outcomes     for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more     youth- and family-centred, and be more cost-effective.   "
34358|NCT02836067|"     The purpose of this study is to learn how smoking affects the immune systems in people with     HIV infection. The investigators would like to know if HIV infected smokers who quit smoking     have different responses in their tissues from people who keep smoking.   "
34359|NCT02836054|"     Analysis of 4 CSF Alzheimer's disease biomarkers (total and phosphorylated tau protein, Aß40     and Aß1-42) and morphological brain MRI in older patients (>60 year's old) with bipolar     disorder, after an evaluation of their cognitive functions.      Comparison between two groups of patients : patients with cognitive disorders and patients     without cognitive disorders.      The objective is to describe and compare the profile of those biomarkers in those two     populations.   "
34360|NCT02836041|"     The investigators want to better understand how children sleep at night at MSKCC, so that the     investigators can learn how to improve the sleeping environment.   "
39639|NCT02766777|"     A study of the safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to < 18 years     diagnosed with Functional Constipation   "
34362|NCT02836015|"     The investigators seek to apply a shared medical visit model and interdisciplinary approach     to Spanish-speaking patients. The investigators will evaluate the patient's hemoglobin A1c as     a marker of glycemic control and evaluate their mood with PHQ screening tools. The     investigators seek to improve diabetes care for this group of underserved patients. Potential     participants will be selected from the UNMC diabetes registry. Eligibility criteria includes     adult patients over the age of eighteen years old with Type 2 diabetes, HgbA1c greater than     8%, whose preferred language is Spanish. Exclusion criteria include pregnancy, residency at a     nursing home or other facility, substance abuse, and physician recommendation that study is     not appropriate for the patient.   "
34363|NCT02836002|"     This is a single-center, open label study. The primary aim of this project is to develop a     controlled human malaria infection transmission model (CHMI-trans) or challenge model to     evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to     block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf)     gametocyte carriers for Anopheles mosquitoes.   "
34365|NCT02835976|"     This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum     of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the     pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.   "
34366|NCT02835963|"     No studies have analyzed the predictive value of different anamnestic and clinical signs for     the diagnosis of acute heart failure (AHF) in patients admitted to emergency department.     That's why the expert group of the AHF of South West of France mobilizes to conduct this     study to evaluate the diagnostic predictive value of different anamnestic and clinical signs     for the diagnosis of AHF to emergencies.   "
34371|NCT02835898|"     Objective: The aim of this pilot study is to evaluate the alterations of epigenetic patterns     in periodontally diseased individuals, before and after periodontal treatment, also in     comparison to periodontally healthy patients.      Materials & methods: Twenty patients were voluntarily enrolled in two groups: 10 participants     with healthy periodontium, and 10 participants with chronic periodontitis. Clinical     parameters were recorded and gingival biopsies were collected within the following timelines:     At baseline (for both groups), after 15 days (for the diseased group only) and after two     months (for the diseased group only).   "
34372|NCT02835885|"     The purpose of this study is to determine the feasibility and safety of Transcutaneous Vagus     Nerve Stimulation (tVNS) in healthy controls. Tested in healthy subjects (HS) the     physiological effects of tVNS at different stimulation parameters. The electrical stimulation     variables will be pulse width, frequency, and current. This will be tested in a laboratory     setting and will measure tVNS effects on heart rate, respiration rate, blood pressure, and     perceived pain. This is a feasibility and small safety study.      Hypothesis: tVNS is feasible and safe   "
34373|NCT02835872|"     There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in     order to confirm the product's efficacy. Thus, the objective of this study is to assess the     effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women.   "
34374|NCT02835859|"     The purpose of this study is to collect data that will help researchers better understand the     various causes of obesity and diabetes; particularly to understand how consumption of NCASs     affects the way the body uses nutrients.   "
34375|NCT02835846|"     This purpose of this study is to understand the types of bacteria that are in the bladder and     vagina in patients with overactive bladder (OAB) symptoms and understand if the types of     bacteria change when with the use of estrogen in the vagina. The investigators are also     trying to understand how estrogen influences the body's ability to make substances called     peptides that can kill bacteria.   "
34423|NCT02835222|"     This pilot phase II trial studies how well selinexor works when given together with     induction, consolidation, and maintenance therapy in treating older patients with acute     myeloid leukemia. Selinexor may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and     daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Selinexor with induction, consolidation, and maintenance therapy may kill more cancer cells     in older patients with acute myeloid leukemia.   "
34376|NCT02835833|"     Angiogenesis, the development of new blood vessels, plays an important role in the disease     development and tumor growth in many solid organ malignancies. Bevacizumab was the first     anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with     multiple tumor types. However, the responses from Bevacizumab are often transient due to the     tumor's manipulative abilities to circumvent the usual pathways to find salvage pathways     instead.      Nintedanib has demonstrated anti-tumor activity in non-squamous non-small cell lung cancer,     colorectal cancer, ovarian cancer, and renal cell cancer. The combination of Bevacizumab and     Nintedanib are being proposed to target the tumor's manipulation processes to generate     alternate pathways for angiogenesis thus creating a potential benefit to delay tumor growth.   "
34377|NCT02835820|"     Randomized control pilot 12 week feeding trial to compare the preliminary effects of     ketogenic diet (versus patient choice diet) on HIV-associated neurocognitive impairment. N =     20 (n = 10/10) randomized to diet condition. Pilot data necessary to evaluate the feasibility     and determine initial data for primary outcomes in order to accurately determine needed     sample size for larger clinical trial.      Outcomes: 1) cognition (NIH Toolkit), 2) cardiometabolic markers (insulin glucose, insulin     resistance, markers of inflammation), and 3) neural activity (as determined by functional     MRI..   "
34378|NCT02835807|"     A sample of mothers in Tennessee are recruited to a group-randomized pretest-posttest     controlled trial evaluating the effect of a social media campaign to decrease mothers'     permissiveness for daughters to indoor tan. The primary outcomes is mothers' permissiveness     for indoor tanning by daughters. Secondary outcomes are mother's indoor tanning prevalence     and their support for stricter bans on indoor tanning by minors.   "
34379|NCT02835794|"     The purpose of this study is to determine the safety and establish the maximum tolerated dose     (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed     and/or refractory MDS.   "
34380|NCT02835781|"     Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls     reconstructions. However, it is solely used in breast reconstructions after breast carcinoma     amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to     current treatment options, however, this has to be proved.   "
34381|NCT02835768|"     Background: Provision of anticipatory guidance to parents is recommended as an effective     strategy to prevent injuries among young children. Internet-based anticipatory guidance is     suggested to reinforce the effectiveness of injury prevention, and improve parents' knowledge     on child safety. Parents receiving the guidance can reduce children's exposure to injury risk     by adopting better childcare practices and using appropriate child safety devices at home.      Objective: This study will examine the effectiveness of Internet-based injury prevention     program with parental anticipatory guidance in enhancing mothers' knowledge on child safety.     It aims at increasing mothers' knowledge and motivation of learning about domestic injury     prevention through a new Internet-based intervention model. It also targets to improve     mothers' attitude and perceived behavioral control of domestic safety practice.      Methods: The study would adopt a randomized controlled trial design and recruit 934 mothers     from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong.     Participating mothers will be randomized into the intervention or control group with equal     likelihood. Mothers in intervention group will be provided with free access to an     Internet-based injury prevention program with anticipatory guideline whereas those in the     control group will receive relevant parenting booklet.      Results: It is hypothesized that mothers' general and age-appropriate knowledge on child     safety and motivation of learning about domestic injury prevention as the primary outcome     measures will be enhanced.      Conclusions: The Internet is increasingly recognized as a practical and cost-effective     platform for health education and safety information delivery. The goals of this study are to     examine the effectiveness of a new Internet-based intervention program for improving mothers'     knowledge, and raising mothers' awareness about the importance and consequences caused by     domestic injuries.   "
34382|NCT02835755|"     This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV)     vaccine intervention works in increasing HPV vaccine coverage among young adult gay and     bisexual men. Giving young men information about the HPV vaccine and the importance of     vaccination may encourage them to get the HPV vaccine.   "
34383|NCT02835742|"     Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP.      Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy     study.   "
34384|NCT02835729|"     The purpose of this study is to characterize the regimen limiting toxicities (RLT) and     recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving     remission induction chemotherapy with cytarabine and idarubicin.      Safety and tolerability of Indoximod will also be evaluated at the RP2D in combination with     standard-of-care (SOC) chemotherapy (defined as induction therapy with idarubicin and     cytarabine and consolidation with high-dose cytarabine (HiDAC) in this trial) followed by     single agent indoximod maintenance therapy in patients with newly diagnosed AML as compared     to safety and tolerability of SOC chemotherapy alone.   "
34385|NCT02835716|"     This Observational protocol will attempt to verify two recent and very critical concepts in     ALZ Clinical Research by studying high-risk individuals who already are taking medications     which may prevent the onset of ALZ.        -  It may be possible to determine the future development of ALZ in a preclinical state in          a cognitively normal but high risk individual at least 18-24 months before any symptoms          develop of cognitive impairment.        -  Early treatment of these cognitively normal high-risk persons with subclinical pre-ALZ          can prevent of delay the occurrence and severity of ALZ.      Caveats      Neither this protocol nor the fMRI imaging are designed or intended to diagnose or treat ALZ,     nor develop or use medications or diagnostic neuroimaging outside of already approved and     accepted parameters. Persons who volunteer to be study subjects in this observational     protocol will be under the care of their primary care / specialty physician, who will order     tests and treatments as they see appropriate.      Although there is a very large body of peer-reviewed scientific literature demonstrating that     certain functional MRI patterns are associated with certain neurologic conditions, the     utilization of fMRI for the evaluation of neurologic disorders is still considered an     emerging science and therefore in the investigational stage. Although this protocol will     report on brain patterns of certain neurologic conditions such as cognitive impairment and     Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are     not considered stand alone or diagnostic per se and should always be considered by the PMD in     conjunction with the patient's clinical condition. These data should only be used as     additional information to add to the PMD's diagnostic impression.   "
34386|NCT02835703|"     The purpose of this study is to evaluate safety and efficacy of three main perfusion methods     in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.   "
34387|NCT02835690|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and     efficacy of three doses of pembrolizumab (MK-3475) in adult Chinese participants with locally     advanced or metastatic non-small-cell lung cancer (NSCLC).      Cycle 1 is 28 days long; subsequent cycles are 21 days long.   "
34388|NCT02835677|"     With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of     caregiver assistance, with a concomitant increase in burden for the caregiver. In fact,     effect on caregiver burden can be seen as a potential indicator of the efficacy of MS     management, suggesting that the caregiver is an appropriate and independent target for MS     therapeutic strategies.      MS patients report difficulty implementing and continuing with home exercise, mobility, and     walking programs. This feasibility study will test integration of a successful behavioral     caregiving intervention into clinical practice to improve functioning of Veterans with     multiple sclerosis (MS) and their Caregivers. Caregivers of Veterans with MS will receive a     behavioral caregiver intervention designed to address caregiver coping and management of     patient concerns, with special focus on patient mobility and walking. A pre-post intervention     design will compare outcomes for Veterans and Caregivers.      For Veterans, the intervention will target Caregiver participation in home-based Veteran     mobility activities. MS Caregivers report high burden, stress, and depression involved in     caring for their loved ones, especially as mobility declines and these outcomes are related     to physical and emotional health status of the patient. For Caregivers, the intervention will     focus on improving Caregiver coping and on managing MS-related problems. Outcomes for both     will be measured at baseline, 3 months, and 6 months.      Study Objectives include:        -  Test whether a caregiver intervention can be integrated into an MS clinical setting.        -  Determine whether Caregiver outcomes are improved (depression, burden, anxiety, and          number of Veteran MS problems and safety alerts reported).        -  Determine whether Veteran outcomes are improved (EDSS walk, timed up and go test,          self-efficacy, and depression).        -  Determine which types of Caregivers will benefit most.        -  Determine which types of Veterans will benefit most.        -  Refine materials for future clinical research, translation and implementation.   "
34389|NCT02835664|"     This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000     mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be     hepatic and whole body insulin sensitivity. Secondary objectives, to provide information     about the underlying mechanism, will be muscle mitochondrial function, brown fat activity,     ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body     composition and acetylcarnitine levels.   "
34390|NCT02835651|"     The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid     (C18:0) have different effects on HDL metabolism during the fasted state.   "
34391|NCT02835638|"     The main goal of this French multicenter observational cohort study is to prospectively     collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the     quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart     Failure (HF) with altered ejection fraction, with a predominant central SAS.   "
34392|NCT02835625|"     Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography     (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian     Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early     performance measures, including prognostic and predictive tumor characteristics, radiation     doses and cost-effectiveness.   "
34393|NCT02835612|"     There are several intervention programs involving multisensory and motor stimulations such     as, gym, auditory, visual, vestibular and tactile stimulations. We propose to study a     continuous program of early intervention involving very preterm infants' families in their     first 12 months of life taking the chance of their neuronal plasticity during this period.     Preterm infants born in our institution will be included when they complete 48 hours after     birth (first intervention). All preterm infants and their mothers will be followed during     neonatal period and pre hospital discharge they will have a second intervention ( to measure     parental bond ). After discharge they will be conducted to follow up program and we will     divided all very low birth weight infants included in the study in two groups according     previous randomization:        1. Standard care with motor, and cognition evaluation and intervention according to their          needs        2. Program of early intervention with parents' orientation independently of f the standard          evaluation and care that will be performed.      All phases of neurodevelopment will be evaluated, and the parents will be oriented to     stimulate motor, language and cognition iteratively and continuously at home; this is a     innovative method to improve very preterm neurodevelopment outcome.      Randomization: in neonatal period, preterm infants will be sequentially randomized when they     completed 48 hours after birth in:      Group 1- conventional group (CG): standard care, according to the routine care of the NICU     (skin-to skin care by mother, kangaroo care ).      Group 2- intervention group (IG): skin-to skin care by mother ( kangaroo care ) plus massage     therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from     randomization until hospital discharge. Intervention performed exclusively by the mothers was     based on studies regarding the application of skin stimulations and passive exercises in     preterm infants.      Both groups will receive skin-to skin care by mother (Kangaroo Care) according to the routine     care of the neonatal intensive care unit (NICU).   "
36255|NCT02811198|"     The ultimate aim of this study is to identify a biomarker of suicide risk in MDD by measuring     the hedonic spectrum (pain and reward responsivity), attention and its associated brain     structures using brain scans (fMRI and DTI), as well as the stability of markers over time.   "
34394|NCT02835599|"     REVOLUTION will be a US multicenter observational registry in scope and governed by a     steering committee of approximately 8 experts in NSCLC and outcomes research. The primary     goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be     a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to     those with EGFR mutations may be enrolled following the initial study period as needed to     ensure adequate sample sizes needed to examine primary questions of interest in the EGFR     mutant population. Patients will be enrolled over a three year period across approximately 25     geographically diverse academic as well as community based sites within the US. The five year     follow-up period will ensure robust survival data for correlations with clinical, tumor, and     treatment variables.      The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with     particular characteristics of interest including patients with adenocarcinoma, and EGFR     mutations and effectively evaluate these patients with respect to key outcomes of interest     including overall survival, time to progression, stage at progression, secondary metastases     including brain metastases (at diagnosis and progression), comorbidity burden, and     performance status at index date.      The study design allows a cross-sectional perspective with collection of detailed patient and     clinical characteristics at enrollment followed by longitudinal assessment of clinician and     patient-reported endpoints every three months. Centralized follow-up will be conducted by     having sites upload patient data following each visit via the web-based data system, with     patients who do not show up for site visits being contacted via telephone by the Duke     Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will     be weighted based upon provider specialty and ability to enroll patients with NSCLC with the     specified inclusion criteria.   "
34395|NCT02835586|"     It is a pilot study to evaluate the feasibility and the efficiency of local delivery of     paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the     realization of a large randomized multicentric study. Patients concerned are in critical     ischemia.   "
34396|NCT02835573|"     The purpose of this study is to evaluate the potential diagnostic and prognosis value of     circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial injury     at the emergency department (ED) and intensive care unit (ICU).   "
34397|NCT02835560|"     This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple     regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin     500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of     H.pylori.      Participants are defined as persons who have endoscopically confirmed on gastric or duodenal     ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive     patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based     bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth     Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID.     After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from     the first day dosing.   "
34434|NCT02835066|"     This pilot trial studies patient function/fitness and psychosocial health in improving     health-related quality of life and decreasing treatment-related toxicity in patients with     stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may     help doctors improve conventional therapy in patients with non-small cell lung cancer.   "
34435|NCT02835053|"     The investigators will examine the association between preoperative frailty and postoperative     outcomes and resource utilization after emergency general surgery.   "
34398|NCT02835547|"     The hypothesis is that chronic inflammatory dysimmune state promotes the development of     cardiovascular complications. The biological assumption is based on the fact that chronic     inflammation promotes lesions of the vessel wall (endothelial alterations, calcification,     atherosclerosis). The clinical aim is to allow to identify high-risk patients and to act in     prevention.      The project CARMIN involves the assessment of cardiovascular risk factors, their management,     and their influence on cardiovascular prognosis in patients with autoimmune diseases and     immunodeficiencies acquired. It is based on the creation and monitoring of a cohort of     patients with different types of dysimmune disorders: systemic lupus erythematosus,     rheumatoid arthritis, psoriasis, scleroderma, systemic vasculitis ANCA, kidney transplants,     and hematopoietic stem cells transplants.   "
34399|NCT02835534|"     This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to     rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients.     It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.   "
34400|NCT02835521|"     Introduction; reception must be understood as the offered attention within the relationship     between a healthcare worker and the patient, including attitudes of inclusion, hearing,     valorization of complains and identification of needs, being these individual collective. As     a part of this process, communication is a primary and indispensable toll through which the     healthcare team and the patient interchange information.      Objective: to evaluate the influence of perception of patients suffering of knee     osteoarthritis over fear, catastrophizing of pain and effectiveness, related to     intra-articular injection od corticosteroids.      Material and method: it will be performed a prospective, controlled and randomized study eith     a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint     injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the     outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will be     evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.   "
34401|NCT02835508|"     The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of     JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60     milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male     Japanese participants.   "
34402|NCT02835495|"     Diabetes and obesity are both major public health concerns and the prevalence of diabetes is     even higher in the patient population of the Veterans Administration. This planning project     is designed to adapt a successful weight-loss program for delivery through an existing     outpatient clinic to reach local Veterans at risk for developing diabetes. The information     gathered as a part of this project will be used to plan a larger trial designed to improve     the health of Veterans by offering them a diabetes prevention program through their usual     source of healthcare.   "
34412|NCT02835365|"     Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in     neurology to treat spastic contracture. Several clinical studies have suggested its efficacy     in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose.     French drug authority has authorized its use in 2012 whereas the l'European Association for     the Study of the Liver recommends to perform additional studies on this indication.      The goal of this observational study is to evaluate the use of baclofen for     alcohol-dependence in real life care as well its efficacy.   "
34403|NCT02835482|"     The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between     100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).      If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose     axons form the optic nerve.      No data has been published to date on potential adverse effects of femtolaser cataract     surgery performed in patients with glaucomatous optic neuropathy.      Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed     analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic     neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss     of this layer.      The investigators propose to evaluate the effects of elevated intraocular pressure in     glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.   "
34404|NCT02835469|"     The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after     embryo transfer in patients treated with Menopur® Multidose   "
34405|NCT02835456|"     The aim of this study is to determine if the Sharklet catheter, with its unique surface     micropattern, reduces infections in participants, when compared to a standard silicone     catheter.   "
34406|NCT02835443|"     This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment     of stroke and will help understand if DBS improves motor recovery for patients who continue     to have significant impairment.   "
34407|NCT02835430|"     -  Gingival recession is defined as the apical migration of gingival margin beyond          cemento-enamel junction with the exposure of root surface. More than 20% of the          population presents one or more tooth surfaces with gingival recession.        -  The main conditions leading to the development of this defect are gingival anatomical          factors, chronic trauma, periodontitis, malposed tooth and dentinal hypersensitivity.        -  The main goal of treating gingival recession is to restore the gingival margin to          cement-enamel junction (CEJ) and normal sulcus with a functional attachment.        -  A recent innovation in Guided Tissue Regeneration (GTR) technique is the use of second          generation platelet concentrate, called as Platelet-Rich Fibrin membrane (PRF) that          contains growth factors and cicatricial properties for root coverage procedures.        -  Space is necessary to provide a channel for the migration of progenitor cells towards          and on the denuded root surface, where they can differentiate into cementum and          periodontal ligament cells.        -  Since the gingival recession defects are non-space making, it may be difficult using the          membrane technique alone, and hence, the use of a graft material underneath the membrane          may help to resolve this problem. Root coverage tended to be better with the addition of          demineralized freeze-dried bone allograft (DFDBA). These allografts prevent the collapse          of membrane into the defect, stimulate the proliferation of osteogenic progenitor cells,          and are thus, capable of promoting regeneration of attachment apparatus.        -  Till date, no study is available in the literature on clinical evaluation of CAF          (Coronally Advanced Flap)+PRF+DFDBA vs CAF+PRF for the management of gingival recession          defects.        -  And hence, this study is designed to evaluate the clinical efficacy of DFDBA (Rocky          Mountain Particulate Allograft) for the management of isolated gingival recession          defects.   "
34417|NCT02835300|"     This project will preliminarily validate CampAir, an empirically-based dynamic e-health     intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled     asthma to learn how to manage their illness and improve their asthma control. In addition to     developing a highly novel product for adolescents with asthma, the research proposed for this     project will address unique scientific questions. Despite the high asthma prevalence among     adolescents, few interventions have specifically targeted adolescents. This study is     innovative in that it is among the few to focus on adolescents, who are often overlooked by     the healthcare system. This research will assess factors associated with successful     implementation of CampAir, thereby providing new information regarding how e-health     interventions can be effectively developed and implemented for use with adolescents with     asthma.   "
45194|NCT02694146|"     To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with     coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with     hyaluronic acid (Hylan G-F 20).   "
34408|NCT02835417|"     Background      The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis.     FHR variability is traditionally investigated using Fourier transform, however, fetal     conditions differ from adults (higher frequency, widely instable signal) modifying spectrum     repartition along frequencies, making this approach inappropriate. New mathematic approach,     including Multifractal analysis, adaptative multiscale complexity analysis, nearest-neighbor     based wavelet entropy rate measures, scattering transform, may identify parameters associated     with fetal acidosis. Modern classification system, driven by the data, based on these     relevant parameters should help to dsiccriminate the fetus at risk for acidosis and help the     clinician in decision making for the management and termination of labor. Analysing 20 to 30     minutes sliding windows with these different methods in a limited number of cases (foetus     born with acidosis) and controls (foetus without acidosis) should lead to identify relevant     parameters, which will be submitted to these classification tools. For external validation, a     large database, including more than 4500 FHR recording documented with foetal outcomes, will     be used to evaluate the performance of the combination of parameters identify and     classification system used to discriminate foetuses at risk for short term acidosis or not,     in order to give a relevant information to the clinician before acidosis occurs, to make the     appropriate decision.   "
34409|NCT02835404|"     The objective of this study was to evaluate the efficacy and complication of the treatment of     pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without     platinum in local advanced cervical cancer patients in the short and long term.   "
34411|NCT02835378|"     In France, there is currently no data to directly estimate the number of bilateral upper limb     amputations, their characteristics and therapeutic care.      By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR)     Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the     upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of the     LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic of     amputees patients referred by orthopaedic centres in the United Kingdom , whose population's     characteristics are similar to France) identified 395 incident cases of upper limb amputation     with, 6 bilateral amputations observed. The causes are varied: traumatic, infectious or     related to diabetes. The population was relatively young, aged between 15 and 54 year old.      On this basis, the estimated number of new cases of bilateral upper limb amputations     throughout France should therefore be about 40 incident cases over a 5-year period.      This observational study is aimed at collecting comprehensive and high quality data to     describe the French population of bilateral upper limb amputees.   "
37860|NCT02790073|"     To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and     other parameters of therapeutic response in haemodialysis patients with calciphylaxis     (calcific uraemic arteriolopathy, CUA).   "
34414|NCT02835339|"     The purpose of this study is to learn how medications participant will receive in the course     of their delivery are metabolized (broken down by the body). The investigators hope to learn     more about the way drugs are metabolized by pregnant women, and how those drugs are     distributed in the blood and body compartments and cleared in the urine, and how maternal     body weight affects the metabolism. With this information the investigators will be able to     develop a treatment regimen considering factors in the body that affect magnesium levels so     that the investigators can improve treatment of pregnant women. The goal of the study is to     understand how different dosing of magnesium sulfate affects blood levels of the magnesium in     larger women.      Magnesium sulfate is generally given to patients to protect the mother against seizures in     the case of preeclampsia. Different hospitals in the United States use different doses of     magnesium sulfate. Participants will receive one of two accepted doses of magnesium sulfate     for preeclampsia. The dose is usually 4g - 6g at the start, with another dose of 2-3 g every     hour until 24 hours after delivery. Participants will be assigned to either a dose of 4 g at     the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every     hour until treatment for preeclampsia is complete. Participants will receive magnesium     sulfate in the course of their normal clinical care whether or not they participate in this     study.   "
34415|NCT02835326|"     The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA)     compares a novel community-based exercise and dietary weight loss program to the Arthritis     Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA)     patients.   "
34416|NCT02835313|"     Stroke survivors, as a group, are extremely inactive and this has serious consequences for     them, including an increased risk of a second stroke and developing other diseases. This     study investigates a novel intervention designed to improve everyday activity after stroke by     combining walking training to improve walking capacity with a program to encourage more daily     walking.   "
34418|NCT02835287|"     The overall objective of the proposed cluster randomized trial is to test whether     implementation of protocol-based integrated care will improve CVD risk factors (glycated     hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 18 months and     reduce major CVD events (non-fatal stroke, non-fatal myocardial infarction, hospitalized     heart failure, and CVD mortality) over 3 years among patients with type 2 diabetes and     additional CVD risk factors or clinical CVD compared to usual care in community clinics in     Xiamen, China.   "
45228|NCT02693639|"     The purpose of this study is to determine prediction value of PANX1 expression in infection     post liver transplantation.   "
34424|NCT02835209|"     Mechanical ventilation is a life-sustaining intervention in premature infants with     respiratory difficulties. There is relative consensus when to intubate and provide positive     pressure mechanical ventilation in the presence of respiratory failure. In contrast,     discontinuation of mechanical ventilation during recovery remains largely subjective. A     potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT).     The efficacy of SBT or other tests used in older patient populations in improving clinical     judgment is questionable in the neonatal population with its unique physiology, respiratory     mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a     standard part of neonatal assessment for extubation from mechanical ventilation.      Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine,     lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT.     An SBT performed in one position may not predict infant respiratory status after extubation     in another position. Understanding the impact of infant positioning and work of breathing     indices independently or in combination with an SBT will aid clinicians in decision-making     and potentially decrease neonatal morbidity (inaccuracy with timing and safety of     extubation). This pilot study will begin to explore these clinically relevant factors.      Objectives: This pilot study will investigate the (1) role of infant position on SBT score     and (2) the relationship of work of breathing indices in reference to the SBT score and     infant position.   "
34425|NCT02835183|"     The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1     diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will     be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be     randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and     then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. The     primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators     will be: mean postprandial glucose level and number of events with excessive blood glucose     highs and lows.   "
34426|NCT02835170|"     This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy,     safety of intramuscular injections of autologous immunoglobulin in patients with     moderate-to-severe atopic dermatitis.   "
34427|NCT02835157|"     Fluid resuscitation is the cornerstone of pediatric shock management; current practices of     fluid resuscitation in children are not evidence based. Normal saline is the preferred     crystalloid recommended during initial resuscitation in shock, as the incidence of     hyponatremia is lower with normal saline compared to all other fluids available and commonly     used. However, normal saline has its own set of undesired physicochemical actions. Emerging     data strongly indicate the increased incidence of hyperchloremia, metabolic acidosis and     consequently, acute kidney injury associated with infusion of large volumes of normal saline.     Balanced salt solutions or crystalloids, which have composition resembling plasma but lower     chloride concentrations than normal saline, clearly decrease the risk of hyperchloremia and     metabolic acidosis in adult as well as pediatric studies when used during the peri-operative     period. The results favored balanced solutions in comparison to normal saline. Recent     systematic reviews comparing balanced or buffered versus non-buffered fluids for surgery in     adults favored the former solution as the metabolic derangements were less with the use of     this type of fluid. In adult patients, the two solutions have been compared in various other     settings as well such as in traumatic brain injury and in shock. The results favored balanced     solutions in comparison to normal saline. However, in the non-surgical setting there is a     paucity of evidence on the use of these solutions in children with shock and more evidence     needs to be generated to support or refute the use of this fluid as compared to normal     saline.      Given this background, the investigators decided to compare the effect of two solutions on     the incidence of acute kidney injury in children resuscitated with either of the two fluids.     Children receiving volumes of at least 20 ml/kg in the first hour of resuscitation as boluses     would be enrolled and followed up for the proposed outcome variables. The investigators plan     to enroll 708 patients over a period of 3 years. The investigators believe that the proposed     study will provide the answer to the safety of normal saline which is the most widely     preferred initial fluid for fluid resuscitation in children with shock due to sepsis.   "
34428|NCT02835144|"     The prevalence of addictive disorders in old age is increasing. Age specific and appropriate     therapeutic concepts tailored to in-patients thus represent a promising approach for the     future. The investigated therapeutic intervention is a therapy program for integrated     qualified acute treatment of alcohol and drug problems (TIQAAM).   "
34433|NCT02835079|"     Duchenne muscular dystrophy (DMD) is a progressive devastating disease that affects mainly     boys, with an incidence of about 1:3,500 live births. The pathology of DMD is a result of     non-repaired muscle damage that leads to muscle-tissue replacement by scar tissue, a process     known as fibrosis. Currently, there is no effective treatment for the disease. The only     therapy offered to these boys are steroids which slightly delayed the disease progression.     The boys lose their ability to walk at around the age of 12, and die in the 4th decade of     life from severe heart and lung problems.      In this study investigators will test the efficacy of Tamoxifen treatment in ambulatory DMD     boys. Tamoxifen is a drug used for palliative treatment of breast cancer patients and has an     outstanding safety profile. In addition, Tamoxifen was tested in the past in boys, for other     pediatric indications, and showed an excellent safety with no side effects.      Tamoxifen is being tested in this study, as a therapy for DMD, for the following reasons:      (i) it was shown to have anti-fibrotic effect in multiple in-vivo systems; (ii) it assists in     the repair of damaged muscles.      In other words, Tamoxifen is expected to have a synergistic effect on DMD patients, due to     its dual mechanism of action. Indeed, Tamoxifen was shown to have significant beneficial     effects in the mdx mouse model of DMD. Also, a small compassionate cohort of 3 boys, treated     for 6 months with Tamoxifen, yielded very encouraging results.   "
34448|NCT02834884|"     SPECTArare is a program aiming at establishing a quality assured platform for collecting     clinicopathologically annotated biological material from patients with primary rare tumors (6     new cases/100,000/year) to support biospecimen-based translational research and biomarker     discovery.   "
34436|NCT02835040|"     Pneumonia is the commonest illness requiring hospitalization in Australia. Elderly patients     account for most admissions and incur highest costs due to longer hospitalizations, higher     readmission risks and poor functional outcomes. Previous clinical trials show a number of     medical and allied health interventions can effectively shorten hospitalization or reduce     readmissions, but these have been poorly and inconsistently applied in practice. This     proposed research builds on previous studies by applying these interventions as a     standardized combined package, evaluating their effectiveness in a real world Australian     setting and quantifying effects on both clinical outcomes and health service costs.   "
34437|NCT02835027|"     Study of acute lower ischemia therapies based on data collected from the Swedish Vascular     Surgery Registry between 1994 and 2014.      Primary endpoint is long term amputation-free survival and secondary end-points are 30 days     and 1 year amputation-free survival as well as different revascularization techniques results     and time trends.   "
34438|NCT02835014|"     This study will focus on screening for mental health symptoms in adolescents with type 1     diabetes mellitus (T1DM) while assessing the relationship of these symptoms with a     parent-reported parenting styles survey, and the youth's report of their ability to manage     their own diabetes care through a self-efficacy survey. Gender differences will be explored     in relation to the different measures.   "
34439|NCT02835001|"     Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on     Hyperinflation in Severe Emphysema   "
34440|NCT02834988|"     The investigators hypothesize that performing SLND (instead of complete lymphadenectomy) will     decrease complications such as hemorrhage, lower extremity lymphedema and lymphocyst     formation while enhancing quality of life in EC patients with low risk for nodal involvement.      The investigators also hypothesize that SLND is an effective method of staging these     patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with     newly diagnosed EC and this prognostic information obtained from SLND could guide selection     of adjuvant treatment and improve overall survival.      Using SLND as an alternative may also have additional medical and economic impacts. Prolonged     hospitalization and associated costs can be avoided by shortening overall surgery duration.   "
34441|NCT02834975|"     The investigators hypothesize that tumor cell killing by cytotoxic chemotherapy exposes the     immune system to high levels of tumor antigens.The combination of Paclitaxel/Carboplatin and     Pembrolizumab will invigorate tumor-specific T-cell immunity in this setting by inhibiting     PD-L1/PD-1 signaling, and may result in deeper and more durable responses compared with     standard chemotherapy alone.   "
34442|NCT02834962|"     To study the difference between single and double bundle ACL graft cross-sectional dimensions     compared with native ACL using postoperative 3-D MRI.   "
34443|NCT02834949|"     The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session     (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing alcohol use and     alcohol-related consequences in college students.   "
34444|NCT02834936|"     This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of     advanced pre-treated Non-small cell lung cancer With HER2 Mutation.      To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe     Progression free survival (PFS). To assess the overall survival (OS).      A secondary aim is to obtain safety information.      To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.   "
34463|NCT02834689|"     Walking is encouraged for people with type 2 diabetes but there is little evidence that     performing a bout of walking can improve glucose control. Furthermore, it is unknown how     participant characteristics (e.g., age, sex, medications) impact the acute glucose responses     to walking in people with type 2 diabetes. The primary purpose of this study is to examine     how a standardized bout of walking impacts glucose control assessed over 24 hours using     continuous glucose monitoring. A secondary purpose is to determine whether responses are     influenced by age, sex, and medication use.   "
34464|NCT02834676|"     The aim of the study is to evaluate the clinical effects of Discogel® Radiopaque Gelified     Ethanol as therapeutic substance for nucleolysis application in the patients with cervical     disc hernia who had chronic pain and weakness on the neck, shoulders and arms.   "
34493|NCT02834299|"     This study will compare unguided and guided dialectical behavior therapy (DBT) self-help to     an attention-placebo self-help control condition. Participants with binge eating disorder     will be randomly assigned to one of the three self-help conditions for 12 weeks. Six guided     self-help sessions will take place via secure video-calling. Assessments will take place     before, mid-way through, and after the self-help program as well as at 3-month follow-up. Six     guided self-help sessions will take place via secure video-calling.   "
34445|NCT02834923|"     The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary     clinical intervention frameworks that are commonly invoked to support better type 2 diabetes     (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both     the PCMH and CCM, and focuses on the central role of patients in managing their illness by     engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite     its recognized importance, SMS programs for diabetes continue to demonstrate limited     effectiveness in the real-world of primary care.      SMS is comprised of two complementary and interactive components: (1) patient engagement     (e.g., the process of eliciting and responding to patients emotions and motivations related     to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals,     creating action plans). While several sophisticated SMS programs have been developed for     T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely     ignoring unique aspects of the patient context that drive and maintain health behavior.     Considerable clinical research suggests that the addition of a structured, evidenced-based     program of patient engagement can maximize the effectiveness of SMS programs for patients     with T2DM in primary care.      To date there has been no systematic study of the degree to which fully integrating enhanced     patient engagement as part of SMS will increase the initiation and maintenance of behavior     change over time, and for which kinds of patients enhanced patient engagement is essential.     To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS     behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program     that includes a practical, time-efficient patient engagement protocol, to create a program     with an integrated and comprehensive approach to SMS, called Enhanced Engagement CTH     (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard     to self-management behaviors and glycemic control in resource-limited community health     centers, where vast numbers of patients with T2DM from ethnically diverse and medically     vulnerable populations receive their care. The investigators will use an     effectiveness-implementation hybrid design, employing the Reach Effectiveness Adoption     Implementation Maintenance (RE-AIM) framework to test these two SMS programs for T2DM. This     will provide critical information that will support dissemination and implementation of     effective SMS programs in resource-limited primary care settings, serving diverse and     medically vulnerable populations with much to gain from improved SMS.   "
34446|NCT02834910|"     Enterobacteriaceae are bacteria of the gastrointestinal tract which are also the most     frequently involved in bacterial infections, especially urinary tract infections. Because of     their presence in the gut, these bacteria are the most exposed to antibiotic treatment     administered to patients.      Therefore, many antibiotic resistance mechanisms are observed in some of them. Quinolone     antibiotics are often used because of their distribution in the body, of the great number of     bacterial species that are sensitive to these antibiotics and the possibility to give oral     treatments.      For a long time no transferable resistance gene to quinolones from one bacterium to another     had been observed. This phenomenon has been demonstrated in 1998 in a bacterium of the     Klebsiella pneumoniae species carrying a qnrA gene which encodes a protein that protects the     target of the antibiotic in the bacteria. Since several genes have been observed. These genes     reduce the sensitivity of the bacteria without ever reach detectable resistance levels on the     tests commonly used in the laboratory. However, these genes are often found among     enterobacteria in combination with other mechanisms of resistance to other classes of     antibiotics including beta-lactam antibiotics that are widely used antibiotics.      Moreover, it is considered that quinolone administration to bacteria carrying these qnr genes     could promote the emergence of mutants resistant to quinolones to a more high-level. That     furthers multiresistance emergence when the bacteria is already resistant to beta-lactam     antibiotics.      The aim of this study performed between April 2008 and March 2009 was to collect strains     resistant to beta-lactams because of the production of enzymes, called extended-spectrum     beta-lactamase to determine quinolone resistance gene frequency in these bacteria.      Meanwhile, control patients were selected to seek the emergence of these genes risk factors.      The clinical study failed to identify specific risk factors, however, the biological study     enhanced the knowledge on this issue with the setting-up of a method for rapid detection of     these plasmidic mediated quinolones resistance genes and the description a new plasmid     containing a qnr gene, qnrD, whose study is still ongoing.   "
34447|NCT02834897|"     The purpose of this study and demonstrate the reliability of EOS imaging system in the     measurement of internal diameters of obstetrical pelvis versus Goldstandard current that is     the pelviscanner.   "
34451|NCT02834845|"     Controlled hypotension is a preferred method for reducing surgical bleeding during     septoplasty operations however, the level of hypotension and bradycardia should not disrupt     cerebral oxygenation. On this account, the investigators aim to investigate the effects of     different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation     during controlled hypotension using near infrared spectroscopy.   "
34452|NCT02834832|"     This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the     wear of denture teeth.   "
34453|NCT02834819|"     The purpose of this study is to determine whether nebulized 3% hypertonic saline is more     effective than the current standard of care in the treatment of viral bronchiolitis in     children.   "
34454|NCT02834806|"     This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent -     BioNIR - with a modified delivery system. The BioNIR Ridaforolimus Eluting Coronary Stent     System is a single use device/drug combination product comprising:        -  A mounted Cobalt Chromium (CoCr) alloy based stent        -  A Rapid Exchange (RX) delivery system        -  A polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®        -  Ridaforolimus drug - CAS Registry Number: 572924-54-0 It is indicated for improving          coronary luminal diameter in patients with symptomatic heart disease due to lesions in          vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.   "
34455|NCT02834793|"     This study is being conducted to demonstrate that perampanel given as adjunctive     anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in     participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome     (LGS).   "
34456|NCT02834780|"     The primary purpose of this study is to determine the maximum tolerated dose (MTD) and     recommended Phase 2 dose (RP2D) of H3B-6527 (Part 1), and to assess the safety and     tolerability of H3B-6527 as a single agent administered orally (Part 2) in participants with     advanced hepatocellular carcinoma (HCC).   "
34457|NCT02834767|"     Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence     exists that some behavioral (e.g. exercise based) therapies may assist in lessening the     severity of this disorder. The proposed investigation will examine the effects of eight weeks     of genioglossus muscle strength training on measures of snoring and OSA severity as well as     genioglossus protrusive muscle strength.   "
34458|NCT02834754|"     This is a pilot study that will determine the endoscopic recurrence of Crohn's disease 12     months after curative, resective ileal or ileocolonic surgery in patients receiving     post-operative vedolizumab (Entyvio) or placebo. The investigators hypothesize that the     administration of post-operative vedolizumab will decrease the endoscopic recurrence of     Crohn's disease.   "
34459|NCT02834741|"     This is a first in human study of NYX-2925. It will evaluate single and multiple ascending     doses of NYX-2925 in healthy volunteers.   "
34460|NCT02834728|"     This was a prospective multicenter cohort study of elderly people admitted to medical wards     via emergency departments. Subjects were followed up to 36 months. It aimed to study the     inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included :     85+/-5 years, and mainly women (65%).   "
34461|NCT02834715|"     The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia     rebaudiana bertoni in patients with type 2 diabetes.   "
34462|NCT02834702|"     The study aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical     neck pain (CMNP).   "
34465|NCT02834663|"     Title of study:      Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR)     with DME assessed by microaneurysm changes: A pilot study Objectives To evaluate the effects     of intravitreal Ranibizumab injection on microvascular changes in eyes of mild-to-moderate     NPDR with DME      Primary objective:      To compare microvascular changes assessed by microaneurysm counts in eyes of mild-to-moderate     NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after     treatment.      Secondary objectives:      To investigate other efficacy endpoints including other microvascular, anatomical, visual     acuity change and safety in mild-to-moderate NPDR with DME after intravitreal Ranibizumab     injection from baseline through 6 months after treatment.   "
34466|NCT02834650|"     This study will collect MRI from healthy volunteer boys and boys with Duchenne Muscular     Dystrophy (DMD) to help researchers identify and validate cardiac MRI biomarkers to better     understand the health of the heart and changes in heart health over time in boys with DMD.      Currently, there is a lack of sufficiently well characterized cardiac MRI biomarkers that can     serve as endpoints for detecting on-target and/or off-target cardiac effects during clinical     drug trials for boys with DMD.      Consequently, the first objective is to identify and characterize several cardiac MRI     biomarkers for boys with DMD.   "
34480|NCT02834468|"     The project was undertaken by Qilu Hospital, Shandong University in China. In order to report     the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous     immunoglobulin in the management of newly diagnosed ITP patients.   "
34504|NCT02834156|"     This protocol is a pilot study on standard care. The main goal is to assess the impact of     positioning on lumbar puncture process especially on pain sensitivity in children.      It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period     is one year, and number of inclusions forecasted is about 30. Each patient will have one LP     in a seated position and one in a lying position.   "
34467|NCT02834637|"     Cervical cancer is the most common cancer in women aged 15-44 years in East Africa, and     mortality rates are very high. HPV vaccines are most effective if given to girls who have not     yet acquired HPV infection. In Tanzania, HPV vaccine has been shown to be safe, acceptable     and can be delivered with high coverage (around 80%). However, the cost of delivering HPV     vaccine is considerably higher than costs for traditional infant/child vaccinations. This is     primarily because of costs to establish outreach programmes and associated personnel costs     including nurses who must spend significant time away from their posts to deliver vaccine,     especially if multiple doses are needed. There is global interest in simplifying HPV vaccine     delivery by reducing the number of doses. If a single dose could be given, this could halve     the costs of delivery, making it more accessible to the populations that need it most.     Recently, the WHO recommended that 2 doses of HPV vaccine could be given to young girls,     based on studies in high and upper middle income countries. However in Africa high rates of     infections like malaria and worms can affect immune responses to vaccines. It is essential to     know that reducing the number of doses does not reduce the protective immune response of     these vaccines. The investigators are conducting a trial in Tanzanian girls aged 9-14 years     to establish whether a single dose of HPV vaccine produces immune responses that are likely     to be effective in preventing cervical cancer. Two different HPV vaccines, the bivalent (2-v)     vaccine that protects against HPV 16/18 (the cause of 70% of cancers) and a new 9-valent     (9-v) vaccine that protects against 9 HPV types, will be compared. The trial will randomise     900 girls to 6 groups and follow them for 36 months. Girls will receive the 2-v or the 9-v     HPV vaccine, as 1, 2 or 3 doses. Girls receiving 1 or 2 doses will be compared with those     receiving 3 doses of the same vaccine, to ensure that the reduced dose regimen produces an     immune response that is not inferior to the standard 3 doses. The immune responses in this     study will also be compared with results from other countries where the vaccine has been     shown to be protective. This will provide information about whether a reduced number of doses     is likely to be protective in Africa. This work will be extremely important in informing     future HPV vaccination strategies and will be one of the first randomised trials of 1 and 2     doses of any HPV vaccine in Africa.   "
34468|NCT02834624|"     Premature infants frequently have trouble breathing after birth. If the respiratory disorder     is caused by surfactant deficiency or dysfunction, the disease is treated with a medication     called surfactant that is given to the infant through a tube inserted into the windpipe. This     study will compare the safety of two of the commonly used surfactants, poractant and     calfactant,in the United States. Poractant has added chemicals called phospholipids which are     known to cause inflammation and irritation in the body of premature infants. The     investigators will compare this to another similar surfactant that does not contain these     chemicals by looking at samples from the windpipe, while the tube is in place, and from blood     tests in the first few days of life.      The investigators are hoping to learn whether calfactant is a safer therapeutic agent to     treat respiratory distress syndrome in preterm infants compared to poractant.   "
34469|NCT02834611|"     This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced     solid tumors.   "
34470|NCT02834598|"     The study evaluates the benefits of a rocking movement on well-being and attention, through     high-density electroencephalography recordings. The effect of the rocking movement is     compared to a seated position and a lying position.   "
34471|NCT02834585|"     Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100     000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence     and distant metastasis. A link seems to exist between local recurrence and overall survival.     Local recurrence occurs in approximately 16-29% of STS of the limbs. A combination of     resection and radiotherapy is the optimal treatment of primary tumours according to     histological grade and surgical result. Modern imaging techniques such as ultrasound (US),     magnetic resonance (MR) and computed tomography (CT) are normally used to rule-out a     recurrence in patients operated on for STS. However, none of this technique is perfect and     different advantages and drawbacks have to be considered in choosing one or another     technique. In the past, US was used in tumour follow-up to detect tumour recurrences, however     these studies didn't use high-resolution transducers and the timing of imaging respect to     surgery was not defined. The recent advances in transducer technology improved the diagnostic     capabilities of US.      For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality.     The reasons are that US is widely available, fast, easily repeatable and often more     accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers     have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in     the evaluation of superficial soft-tissues. US and MR Imaging are often not able to     differentiate benign from malignant tumours, therefore several lesions detected with US or MR     Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of     Medical Oncology) published in 2010 found that there are no published data to indicate the     optimal routine follow-up policy of surgically treated patients with localized disease.     Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is     superior and cost-effective compared to US for the assessment of the primary site.     Considering that surgically treated intermediate-/high-grade patient may be followed     frequently, even every 3-4 months in the first 2-3 years and considering that performing US     is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic     performance of US in the detection of local recurrences of adults patients with soft tissue     sarcomas of the limb.   "
34489|NCT02834351|"     The purpose of this study is to evaluate the effect of muscle ischemia during claudication on     mitochondrial function.      Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac     group) feasibility study.   "
34490|NCT02834338|"     Randomized Controlled Trial to monitor and increase the postoperative mobilization of the     patients undergoing major visceral surgery by giving a continuous autofeedback of the step     count using activity tracking wristbands.   "
34472|NCT02834572|"     Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at     severely disproportionate rates. A key component of HIV prevention for communities at risk is     diagnosing HIV infections through regular HIV testing. A significant proportion of young     Black MSM and transwomen have not tested in the prior year. This research study seeks to     address low HIV testing rates among young Black MSM and transwomen by testing a brief     Internet-based HIV testing intervention optimized for mobile devices. The intervention takes     advantage of the variety of HIV testing options now available, including the HIV self     testing, couples-based HIV counseling and testing and traditional clinic-based testing and     will provide men and transwomen with a tailored recommendation of their optimal HIV testing     approach. The investigators are conducting a pilot randomized study among young Black MSM and     transwomen followed for 6 months to estimate the intervention's potential efficacy in     increasing HIV testing.   "
34473|NCT02834559|"     This study investigates the effectiveness of a simple treatment to prevent proliferative     vitreoretinopathy (PVR).      Intraoperative intravitreal 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) is     used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal     detachment (RRD). Our major motivation is to reduce the incidence of PVR in the group that     receives the trial drug.   "
34474|NCT02834546|"     The aim of this pilot study is to correlate the sorafenib plasma concentration to observed     toxicity and to the disease control rate in 100 patients undergoing a palliative treatment of     hepatocellular carcinoma (HCC). If some correlations are observed, we will consider planning     a larger interventional study to adjust sorafenib daily dose to plasma concentration.   "
34475|NCT02834533|"     Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait     training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS).      Method: A Randomized, double-blind, controlled clinical trial was carried out in forty     patients with relapsing remitting MS. All patients were randomized into two groups. One group     practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the     groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded     neurologist and psychologist administered clinical and neuropsychological scales. All the     clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative     program.   "
34557|NCT02833454|"     The purpose of the study is to study the effect of anatomical direct insertion ACL     reconstruction compared with conventional anatomical ACL reconstruction.   "
34482|NCT02834442|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     MT-7117 in healthy subjects.   "
34483|NCT02834429|"     The aim of this study is to assess the clinical utility of the whole blood     transglutaminase-based rapid test against current serological tests and the gold standard of     duodenal biopsy. The investigators will recruit patients (n=1000) from the endoscopy     department at the Royal Hallamshire Hospital, Sheffield, United Kingdom (UK). The patients     recruited for this study will already have been referred for a consultation and gastroscopy.     In addition, these patients will already have been serologically tested for IgA TTG, EMA and     a total IgA immunoglobulin level (as per normal clinical practice).      All duodenal biopsy specimens will be fixed in buffered formalin and embedded in paraffin     wax. Standard, 3μm thick sections at three levels will be stained with haematoxylin and eosin     and reported routinely. Additionally, biopsies demonstrating increased intraepithelial     lymphocytes only (changes compatible with but not diagnostic of coeliac disease) will be     stained with KiRAS or CD4/CD8 which are markers for coeliac disease.   "
34484|NCT02834416|"     Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive     androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but     has many side effects. Researchers have shown that exercise, specifically one-on-one     supervised exercise improves many of the side effects of ADT. However, exercise programs for     men on ADT are not widely available. More questions need to be answered in order for exercise     programs to become part of PC treatment. First, can programs that require fewer resources,     such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do     exercise-related benefits continue beyond the structured exercise program? And what makes     people continue exercising? Third, which exercise program is most cost-effective?      In this study, the investigators will compare: (a) group supervised in-centre and (b)     home-based supported exercise programs to see which program is most effective for men with PC     on ADT. The investigators will also look at what motivates people to continue to exercise     both during a structured program and after the program is complete and will examine which     exercise program is most cost-effective.      Participants (men with PC on ADT) will be recruited from one of the following cancer centres:     Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary, the     Juravinski Cancer Centre in Hamilton, and the Southlake Regional Health Centre in Newmarket.     When a patient agrees to participate, patient will be randomly placed in 1 of 2 exercise     programs. All programs will include the same type of exercises (aerobic, resistance and     flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as     tolerated) for the length of the program (6 months). The investigators will look at how men     with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue     and different physical measures before, during, and after the exercise program.      Although the investigators know that supervised one-on-one exercise is most effective at     improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial     and more financially responsible. This study will allow the investigators to begin to answer     these questions so that structured exercise programs become a regular part of PC treatment.   "
34485|NCT02834403|"     This is a Phase Ib/II study assessing the maximum tolerated dose (MTD), dose-limiting     toxicities (DLTs), recommended Phase 2 dose (RP2D), and efficacy of L-NMMA when combined with     docetaxel in refractory locally advanced or metastatic triple negative breast cancer     patients. The Phase Ib portion of the study is designed to investigate the combination at two     dose levels of docetaxel (75 and 100 mg/m2) and 6 dose levels of L-NMMA (5, 7.5, 10, 12.5,     15, and 17.5 mg/kg). The starting dose of L-NMMA will be 7.5 mg/kg. In the Phase II portion     of the study, the starting dose will be the RP2D determined in the Phase Ib portion of the     study.   "
34486|NCT02834390|"     This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the     pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of     the combination of quizartinib and induction and consolidation chemotherapy.   "
34487|NCT02834377|"     The purpose of this study is to evaluate the effectiveness of using the personal     preoperatively assessed cardiac output in high-risk patients to guide perioperative     administration of fluids and vasoactive drugs on predefined postoperative complications.   "
34488|NCT02834364|"     Trial for patients with refractory multiple myeloma after failure of at least two treatment     regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors     Encorafenib (LGX818 in) combination with Binimetinib (MEK162).   "
46435|NCT02677805|"     The aim of this study is to assess the efficacy and safety of BoNT/a-DP in the treatment of     glabellar lines in comparison with placebo, including efficacy after repeat treatments and     long term safety.   "
34495|NCT02834273|"     The rapid diagnosis and treatment of acute ischemic stroke are critical in the reduction of     morbidity, disability and stroke associated mortality Under-education about stroke may     prevent people from recognizing symptoms early enough to seek immediate care.      The studies reported on stroke patients managed in stroke center have shown that 39-42% of     patients could not name any symptoms of stroke and 36% to 43% no risk factor of stroke.      The stroke patients are therefore a population at high risk for neurological events and     cardiac vascular recurrence. However, no studies have evaluated the interest of the     development of therapeutic workshops in stroke unit to educate patients about symptoms     suggestive of stroke, risk factors and what to do in cases of stroke.      Investigators assume that the setting up of a therapeutic education workshop in the stroke     unit may allow a better understanding of the symptoms, risk factors and what to do following     stroke. So there is a direct benefit to the patient represented by a better knowledge of     stroke (warning signs, risk factors, what to do), improved treatment compliance and reduced     risk of recurrence.      More generally, there is a real benefit to promote these messages to the public through the     patient and his relatives   "
34496|NCT02834260|"     Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and     constitute one of the main factors reducing graft survival. They mainly occur during the     first 18 months. Prevention usually relies on a topical treatment with dexamethasone or     prednisolone for standard risk patients. Eye drops are instilled three times a day during at     least 3 months then tapered.      OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone     during several months. It is indicated for intravitreal injection to treat macular edema.      The investigators hypothesized that this implant could be used after subconjunctival     injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop     instillations.   "
34497|NCT02834247|"     The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended     Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in     participants with advanced solid tumors.   "
34498|NCT02834234|"     Peritoneal mesothelioma is a rare disease representing one third of all mesothelioma and     nothing is known about molecular characteristics of this disease. As main cancers, genetic     heterogeneity is probable. This genomic profiling associates Comparative Genomic     Hybridization (CGH) array, BAP1 sequencing and gene expression in order to discover a     biomarker that could be used in the treatment of this rare disease. Corresponding     histopathological and immunohistochemical report as all clinical data are available. All data     with be merged to underline a few genes of interest on which we will focus our next     investigations. Depending of our preliminary results, BAP1 mutations are expected, as it was     also described in pleural mesothelioma. Mutations in oncogenic drivers that could be targeted     by specific therapy will be on particular interest in management of this rare disease with     bad prognosis.   "
34499|NCT02834221|"     This study is designed to evaluate the use of real-time ultrasound-guided femoral     venipuncture during pulmonary vein isolation for treating atrial fibrillation .   "
34500|NCT02834208|"     Schizophrenia is an invalidating psychiatric illness with a strong genetic component     characterized by abnormal processing of emotional information. This alteration in emotion     processing has been described in acute as well as in remission phases of the illness. It has     also been found in healthy relatives of patients with schizophrenia and in subjects at high     risk of psychosis. Thus, alterations in emotional information processing are not only linked     to the prognosis but can also be considered as a marker of vulnerability of schizophrenia. In     addition, schizophrenia patients differ from healthy controls in neural activity in brain     regions implicated in emotions processing. However, interpretation of findings in patients is     limited by confounding factors, such as antipsychotic treatments or alterations due to the     course of illness. Also, there is no data concerning genetic factors (polymorphisms or gene     expression) underlying these patterns of cerebral activation in emotion information     processing.      So, the main objective of this study is to compare the cerebral activity of schizophrenia     patients to that of healthy siblings and healthy controls in an emotional processing task.   "
34501|NCT02834195|"     Cerebral palsy (CP) has been defined as a group of permanent disorders of the development of     movement and posture causing activity limitation(s) that are attributed to non-progressive     disturbances that occurred in the developing fetal or infant brain.      Investigators previously developed two classification systems, one for the upper limb and one     for the hand, based on 100 films of patients with cerebral palsy. Separate classifications     were developed following an initial study in which investigators found no correlations     between upper limb and hand patterns, meaning that specific upper limb patterns are not     always associated with specific hand patterns. Thumb patterns were not included in these     classifications since robust classifications already exist, moreover thumb patterns are     independent from hand patterns.      The aim is to evaluate the inter- and intra-rater reliability of two previously developed     classifications of upper limb and hand patterns.   "
34502|NCT02834182|"     Theory of mind (TOM), a main component of social cognition processes, refers to the capacity     to infer one's own and other person's mental states. Deficits in social cognition are found     in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare     the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy     participants during the performance of a TOM task. Results may help to understand the neural     bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may     in turn help to propose potential new psychosocial therapeutic approaches in these disorders.   "
34503|NCT02834169|"     Despite advances in the management of and changes in clinical practice, little is known about     the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies     patients in France.      In order to better understand the characteristics of rare peritoneal surface malignancies and     to evaluate treatment strategies, the RENAPE registry aims at the collection of data from     patients presenting with a rare peritoneal surface malignancy in France. Data will be entered     prospectively in a specifically designed and secured web database.      All RENAPE's centres and physicians are invited to register patients with a rare peritoneal     surface malignancy diagnosis and to participate to the registry. Data will be evaluated     within regular time frames, focusing on types of rare peritoneal surface malignancies,     treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing     to the better understanding of these rare cancers.   "
34505|NCT02834143|"     Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial     disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there     are no recent epidemiological data on morbidity and mortality of critical ischemia. Moreover,     the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and are not     subject to a clear consensus.      Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European     working group) in a population of severe ischemia in patients in order to offer relevant     simple and reproducible criteria. Secondly Investigators propose to monitor the medium and     long term evolution of these patients ICC defined to clarify the prognosis.      diagnostic criteria of the different societies:        -  TASC: Transatlantic criteria: very characteristic pain, wound optional, variable          hemodynamic criteria as the presence of a wound or not        -  VALMI: French criteria derived vascular medical college: characteristic pain, sore,          hemodynamic reproducible, reliable criteria        -  European working group: European definition of criteria, including a characteristic          pain, requires no wound, different hemodynamic criteria of 2 others.   "
34506|NCT02834130|"     Severe forms of hemophilia and other constitutional bleeding disorders represent a group of     rare diseases. In last decades, news therapies have dramatically increased life expectancy     and joint's protection.      The investigators propose to set up a single-centre, descriptive, transversal pilot study,     designed for the inclusion of around thirty children from 2 to 10 years, with haemophilia or     allied hereditary bleeding disorders (HBD), who were referred to the Hemophilia Treatment     Center (HTC) of Marseille at diagnosis. For those children who were able to benefit from the     totality or part of the device accompanying the diagnostic announcement in the past 10 years.   "
34507|NCT02834117|"     Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of     infertility. This method is performed in presence of supernumerary embryo(s) after fresh     transfer, or after freeze all embryos in case of medical reasons. It is necessary to control     that the transfer is performed when the endometrium is receptive, which is essential for     embryo implantation and pregnancy. This period is defined as the implantation window.     Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate     ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a     natural cycle (NC). The objectives of this open randomized study is to compare the number of     visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of     life in both groups.   "
34508|NCT02834104|"     Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix     remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions     despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased     myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present     clinically with symptoms of cardiac failure although this is often a subclinical disease.     Various imaging modalities and collagen biomarkers have been used as surrogate markers to     assess the presence, extent, and turnover of myocardial fibrosis. Techniques using     echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to     detect early features of systolic and diastolic left ventricular dysfunction and impaired     contractile reserve. Further identification of diffuse reactive fibrosis may be possible with     evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol is to     validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification against     histology as standard of reference.   "
34509|NCT02834091|"     The use of hypnosedation in the context of anesthesia is validated. This is a technique that     combines the hypnosis procedure as intravenous sedation. For surgery, it is associated with     local anesthesia surgical site. It can favorably replace general anesthesia if surgery or     endoscopy allows but doctors will always need local anesthesia surgical site where surgery     The hospital Paris Saint joseph introduced gradually this technique from first in 2007 to the     operating room and in the various services of conventional and ambulatory hospitalizations.      The goal of the investigators is to evaluate these parameters on a prospective cohort of     patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or     surgery.   "
34510|NCT02834078|"     According to the International Diabetes Federation, one in every 12 individuals is a diabetic     (about 8% of the world population). Major risk factors of diabetes are all the aspects of     modern life which include obesity, over-weight, high-risk behavior like smoking, alcohol,     multiple drug use-recreational or prescribed, environmental risk factors like inactivity and     lack of exercise. However there is a window of opportunity between health and disease, which     is pre-diabetes.      Pre-diabetes has been defined by American Diabetes Association as Impaired Glucose Tolerance     (IGT) which is 7.8 -11.0 mmol/l, Impaired Fasting Glucose Test (IFT) which is 5.6-6.9mmol/l     and now added Glycosylated Hemoglobin (HbA1c) of 5.7% to 6.4%.      Though there are plenty of drugs available for significantly impaired glucose metabolism     (including oral hypoglycemic agents and insulin), their use in marginally impaired glucose     metabolism is questionable due to risk of untoward hypoglycemia.      On the other hand, herbal products like curcumin, as a single ingredient has poor     bioavailability problem that restricts its use as standalone treatment. Inulin works as     pre-biotic and help to maintain gut microbiota which is considered as precursor for progress     of prediabetes to diabetes. However, it does not have any role in primary pathophysiology of     impaired glucose metabolism, i.e. pancreatic β cell dysfunction, insulin resistance, hepatic     gluconeogenesis or intestinal glucose absorption. Resveratrol and omega-3 basically work on     anti-oxidant pathways.      None of these popular ingredients has been studied for their role in structural and     functional health of pancreatic β cells which is very important for prediction of further     progress of marginally impaired glucose metabolism to significantly impaired glucose     metabolism.      It is an unmet need to develop a product which not only improves insulin sensitivity, but     also help to preserve the structural and functional health of pancreatic β cells. It also     needs to improve overall metabolic and endothelial health of the person considering the close     association between impaired glucose metabolism and these parameters.      The proposed supplement - Berberine GlucoGold - is an improved version of successfully     marketed supplement - Berberine GlucoDefense. It has a balanced composition in which all the     ingredients complement each other in such a way that along with the individual role in     glucose metabolism it also takes care of overall bioavailability and stability of the     supplement. As per the previous data on ingredients, the supplement is also expected to     preserve the structural and functional health of pancreatic β cells. The ingredients are also     known to have positive effect on overall metabolic and endothelial health. Thus BGG has been     developed to address the unmet needs in the area of glucose metabolism and overall metabolic     health.   "
34511|NCT02834065|"     In this study the investigator will randomize 273 subjects to deep (<20°C), low     (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with     circulatory arrest. The primary purpose of this study is to determine the effect of deep vs     low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and     leukocyte SUMOylation patterns after surgical circulatory arrest in participants.   "
34629|NCT02832505|"     This study has two major purposes:        1. To test developed multiple anatomic and functional MRI methods;        2. To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and          monitoring of the progression of renal dysfunction.      These purposes will be achieved by performing pilot studies with cohorts of patients.   "
34512|NCT02834052|"     The main purpose of this study is to determine the dose of poly-ICLC that is safe and     tolerable when it is combined with pembrolizumab in patients with colon cancer. This study     will also evaluate how the combination of pembrolizumab and poly-ICLC activates the immune     system in the patient's blood and inside the tumor; how it affects the size and number of     tumor(s) in each patient; and how effective the combination is in patients with colon cancer     that is unlikely to respond to pembrolizumab alone.   "
34513|NCT02834039|"     This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and     tidal volume 10ml/kgBW in laparoscopic nephrectomy patients   "
34514|NCT02834026|"     Muscle strength can be measured by dynamometry, but the investigators did not find in the     literature the study of this technique in the quadriceps of patients with chronic kidney     disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps     muscle strength in patients with chronic kidney disease during hemodialysis. This study will     be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a     university hospital, over 18 years, of both genders who underwent hemodialysis for more than     six months and signed the consent form and enlightened. Patients will be divided into two     groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics     and quadriceps strength given by standardization of technique, with hard and windy belt. The     control group will be reassessed after two months of the initial assessment, since the     intervention group held two months of training in hemodialysis a physical therapy protocol     with the cycle ergometer.   "
34516|NCT02834000|"     Continuous cardiovascular monitoring as part of management of high-risk surgical patients is     widely practiced, however its role in low-risk surgical patients is unclear. Detailed     monitoring of cardiovascular parameters from pre-induction stage allows clinicians to     individualise anaesthetic management in the perioperative period. The investigators' aim was     to investigate haemodynamic and Bispectral Index (BIS) changes in healthy patients undergoing     surgery following induction of anaesthesia with propofol using a continuous non-invasive     blood pressure device (LiDCOrapid™).   "
34517|NCT02833987|"     The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs)     is associated with an increased risk of major bleeding compared to warfarin use, for the     treatment of venous thromboembolism (VTE).      The investigators will carry out separate population based cohort studies using health     administrative databases in eight jurisdictions in Canada, the UK and the US. Cohorts will be     defined by the initiation of a DOAC or warfarin on or after January 1, 2009, with an incident     diagnosis of VTE having occurred within 30 days prior to the date of the prescription for the     DOAC or warfarin. Follow-up will continue until a hospitalization or emergency department     visit for a major bleed. The results from separate sites will be combined to provide an     overall assessment of the risk of major bleeding in DOAC users.   "
34518|NCT02833974|"     This study will assess whether Toll like receptor 7 (TLR7)-mediated pharmacology, with     intranasal (i.n.) GSK2245035 20 nanogram (ng) administered weekly for a period of 8 weeks,     will lead to reduced allergic reactivity in the lower airways in subjects with mild allergic     asthma.      This will be a randomised, double-blind (sponsor open), placebo-controlled, parallel group,     8-week treatment study.      The study will consist of a screening period of up to approximately 4 weeks (involving two     screening visits), a blinded treatment period of 8 weeks, followed by a follow-up period of     up to 3 months. The total duration of the study for each subject will therefore be a maximum     of approximately 6 months.   "
34520|NCT02833948|"     The aortic valve is located between the left ventricle and the aorta. Patients with     symptomatic, severe aortic valve stenosis conventionally have it surgically replaced     requiring direct access to the heart through the chest. Transcatheter aortic valve     replacement (TAVR) is now a well-established alternative for treating severe aortic valve     stenosis. Both types of intervention improve prognosis and alleviate symptoms.      The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that     leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been     suggested to be potentially related with neurological events. In addition, the occurence of     this phenomenon can be reduced with anticoagulation blood thinning therapy.      The purpose of this study is to evaluate if anticoagulation compared to the usual double     platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.   "
34772|NCT02830633|"     The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved     total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether     LNTME is more effective for protection of pelvic autonomic nerve function from surgical     impairing when comparing to open TME.   "
34521|NCT02833935|"     Pilot randomized controlled trial evaluating a Self-Determination Theory (SDT) video-based     tele-rehabilitation physical activity intervention aimed to enhance basic psychological     needs, motivation, physical activity (PA), and quality of life- related outcomes of adults     with spinal cord injury (SCI). It is anticipated that the individuals who receive the     physical activity intervention (intervention group) will have moderate increases in their     basic psychological needs, autonomous motivation, life satisfaction, and physical activity     participation, and a moderate decrease in controlled motivation and depressive symptoms     compared to the individuals who did not receive the intervention (control group).   "
34522|NCT02833922|"     The purpose of this study is to assess the effectiveness and efficacy of Dynamic Optimal     Timing (DOT), an app-based method of family planning that can be used via Android devices,     for women who use the method to avoid pregnancy.   "
34523|NCT02833909|"     The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa     (HS) (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of     patients treated surgically for this disease.      The investigators hypothesize that Th17-derived cytokines, especially Interleukin (IL) IL-17,     could serve as a relay in the inflammatory process leading to HS severity and recurrences.   "
34543|NCT02833649|"     To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to     evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data     preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable     Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up     from this standardized, multi-center clinical investigation, support from clinical and     optical viewpoints TICL implantation, in stable keratoconus.   "
34524|NCT02833896|"     Medical context:      Several molecular studies showed chromosomal alterations in patients with endometrial cancer,     with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of     interest have been dentified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). It is thus     conceivable that like that enable genomic tools used in breast cancer today (Oncotype DX,     MammaPrint), correlation between the tumor profile and life project in the case of cancer the     endometrium could be done. A study is already underway at the Reims University Hospital with     funding from the League against cancer and AOL in 2010 CHU Reims. It should identify the     specific alterations of nosologic continuum of pathology and characterize areas of interest     on the genome. To date, 39 patients with endometrial cancer and 15 patients with endometrial     hyperplasia (patients 'cases') were included in the study. For this study, 10 patients     exhibiting neither cancer nor endometrial hyperplasia were also included. Samples of these 10     patients 'witnesses' were pooled to serve as a reference for analyzing patients 'cases'.      objectives: In continuation of the study began in November 2009, refine the study of genomic     imbalances highlighted hyperplasia and endometrial cancer by studying the in correlation     between genomics and proteomics by immunohistochemical studies and analyzing the     microsatellite instability.      To study the prognostic role of genetic factors in patients carriers of a disease endometrial     (cancer or hyperplasia).      Material and methods :      Experimental Design: Cross-sectional study in inclusion prospective multi-center followed by     a cohort study of patients 'cases'.      Population / patients: in total, it is planned to include 72 patients with hyperplasia or     endometrial cancer (22 patients included in the pre-study part funded by the League against     cancer 50 patients included in the scope of the study funded by the 2010 AOL Chu Reims).      Plan of investigation: the study includes two phases:      Sectional study:      The inclusion of 10 patients witnesses has already been completed in the first project.      During the consultation in the obstetrics and gynecology department of the Reims University     Hospital and the surgical department of the institute Jean Godinot, terms and objectives of     the study have been and will be presented to patients where cancer or hyperplasia endometrial     was diagnosed by achieving endometrial biopsy.      If the patient agrees to participate in the study, the management of its pathology     (hysterectomy, hysteroscopy and curettage resection) will not be changed.      The samples taken during the surgery were analyzed and will be as provided in the first     research project. Tumor karyotype, DNA extraction are performed on each sample fresh. A     comparative genomic hybridization is conducted using the DNAs thus obtained.      Additional analyzes (immunohistochemistry and analysis of microsatellite instability) will be     performed on all samples already obtained and on future withdrawals.   "
34525|NCT02833883|"     The main purpose of this study to define the good and/or bad effects of the combination of     enzalutamide and CC-115 in patients with castration-resistant prostate cancer.   "
34526|NCT02833870|"     Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health     challenge. Because of the limited effectiveness of pharmacological treatments, there is a     growing interest in care approach based on nonpharmacological treatments, such as musical     interventions. Several lines of evidence suggest that musical interventions could improve     behaviour, emotion and even cognition in patients with AD. However, very few studies respond     to the methodological constraints required for clinical controlled trials carried out in well     selected groups of patients. The efficiency of such care approaches is not scientifically     proved yet and the impact of musical interventions has rarely been compared to another     pleasant intervention, leaving open the question about the specific benefits of music in     patients with dementia. The main goal of this research project is to demonstrate short and     longer-term efficiencies and the specificity of musical interventions in dementia by     investigating their effects not only in patients but also in familial and professional     caregivers.   "
34527|NCT02833857|"     This is a multicenter, open-label study to evaluate the safety and pharmacokinetics in     pediatric subjects with secondary hyperparathyroidism receiving a single dose of AMG 416 at     the end of hemodialysis.   "
34529|NCT02833831|"     The primary objective of this study is to evaluate the effect of supratherapeutic exposures     of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel     2).   "
34530|NCT02833818|"     There are few scientific reports on preterm infants with birth weights between 1500 and     2000g. Adequate and properly balanced supply of nutrients believed to better growth and     cognitive development in this patient group, and optimized nutrition is an important part of     treatment There is a need for more studies that can provide knowledge of growth and weight     development in preterm and small for gestational age (SGA) infants with a birth weight     between 1500 and 2000g.   "
34531|NCT02833805|"     Our primary objective is to determine if it is feasible for previously untreated severe     aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and     post transplantation cyclophosphamide.   "
34532|NCT02833792|"     STUDY OBJECTIVES      Primary:      To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem     cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects     with mild to moderate dementia due to Alzheimer's disease.      Secondary:      To assess the preliminary efficacy of hMSCs versus placebo in subjects with     Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric     endpoints.   "
34790|NCT02830373|"     This study aims to investigating the efficacy and safety of low profile visualized     intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular     aneurysms.   "
34533|NCT02833779|"     Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause     of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree     about which type of exercise is most appropriate. Manual Physiotherapy combined with guided     exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been     shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder     with guided self-treatment and conventional physiotherapy yielded a slightly higher     improvement, basically because patients suffered from chronic tendinitis and the treatment     period lasted only two weeks. That is the reason why the investigators propose a long-term     follow-up study and a more complete assessment of effectiveness of the exercise prescribed to     improved this pathology.      Objectives:        -  Assessment of effectiveness of two different types of treatment of subacromial syndrome          of the shoulder.        -  Comparison of effectiveness of both treatments in order to select that one yielding          better results as the one to be applied as a routine practice.      Patients will be assigned one of the following treatments:        -  Group 1: patients will be taught exercises in groups of six people, on a daily basis for          twelve sessions.        -  Group 2: patients will be taught the same exercise as Group 1, individually, and will          receive manual therapy consisting of muscular and joint re-centering.      A modified version of the Constant scale will be used to assess mobility and pain shoulder.   "
34534|NCT02833766|"     The main objective of the trial is to determine the efficacy of doxorubicin-loaded anti-EGFR     immunoliposomes as first-line therapy in patients with advanced triple Negative, EGFR     positive breast cancer. In this proof of concept trial, all patients will have an     administration of the doxorubicin-loaded anti-EGFR immunoliposomes (anti-EGFR-IL-dox) every     28 days, until progression or unacceptable toxicity.   "
34535|NCT02833753|"     This is a Phase I dose escalation study to determine how much chemotherapy can be safely     administered into the abdomen while experiencing the fewest possible side effects.   "
34536|NCT02833740|"     The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of a     set of three simplified mid-upper arm circumference classification devices (Click-MUAC) for     use by mothers and caregivers to screen for acute malnutrition in young children. The study     will be conducted in Isiolo County, Kenya. The study builds on the recent approach of     training mothers to screen for acute malnutrition in their own children (mother MUAC     approach).      The primary aim of the study is to describe and compare the performance of a set of three     prototype Click-MUAC devices against a gold standard of classification, in terms of measures     of agreement (sensitivity, specificity, accuracy, Cohen's Kappa, Youden's J) for the     classification (diagnosis) of acute malnutrition. A secondary aim of the study is to     determine the difference in agreement with the gold standard classification amongst     mothers/caregivers using a Click-MUAC prototype versus mothers/caregivers using a regular     MUAC tape. The hypothesis of the study is that at least one of the Click-MUAC prototypes is     equal to the gold standard of classification in terms of measures of agreement for the     classification of acute malnutrition. A secondary hypothesis of the study is that agreement     with the gold standard classification is better amongst mothers/caregivers using a Click-MUAC     prototype compared to mothers/caregivers using a regular MUAC tape. The outcomes of the study     will be used to decide on whether production of a Click-MUAC device is desirable and, if this     is the case, to select a design based on the performance of the prototype devices and the     stated preferences of intended users.   "
34537|NCT02833727|"     Aim : To compare, among patients with an uncontrolled moderate to severe asthma, the blood     eosinophil levels of smokers and non-smokers.      Secondary aims: In uncontrolled moderate to severe asthmatic subjects, to compare between     asthmatic smokers and non-smokers: sputum eosinophils counts, fractional exhaled nitric oxide     (FeNO), pre and post bronchodilator Forced expiratory volume in one second (FEV1) / Forced     vital capacity (FVC), Asthma-related quality of life, asthma exacerbations during the year     preceding enrolment in the study, Medical direct and indirect costs related to asthma during     the year preceding enrolment in the study, and adherence to asthma treatment during the year     preceding enrolment in the study.      Methods: Cross sectional observational study. Never-smoker and smoker asthmatics treated with     at least 2 controller medications with a smoking history ≥10 pack/year with a ACQ score ≥ 1.5     points will be identified in the database RESP. Their clinical data will be matched to the     Régie de l'assurance médicale du Quebec (RAMQ) and Maintenance et exploitation des données     pour l'étude de la clientèle hospitalière (MED-ECHO) administrative databases and reMed (data     on medications for patients with private health insurance) in order to access to data on     medical services, hospitalisations and medications delivered by pharmacies. T   "
34538|NCT02833714|"     The purpose of this research is to characterize the effect of teriflunomide on the activation     of B-cells, as well as its capacity to modify B-cell cytokine secretion. The in-vitro     identified effects of teriflunomide on the expression of B-cell activation markers,     costimulatory and antigen presenting molecules, as well as on cytokine secretion, will then     be confirmed in a cohort of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated     with this medication.   "
34539|NCT02833701|"     This phase I trial studies the side effects and best dose of ascorbic acid when given     together with bevacizumab in treating patients with high grade glioma that has come back     (recurrent). Monoclonal antibodies, such as bevacizumab may interfere with the ability of     tumor cells to grow and spread. Ascorbic acid contains ingredients that may prevent or slow     the growth of high grade glioma. Giving bevacizumab and ascorbic acid together may work     better in treating patients with high grade glioma.   "
34540|NCT02833688|"     To investigate whether dexmedetomidine reduce liver injury after hepatectomy. During     hepatectomy, surgeons always took inflow occlusion to reduce blood loss with Pringle     maneuver. A few clinical studies had shown dexmedetomidine could reduce ischaemia/reperfusion     (IR) injury caused by the secretion of reactive oxygen species and inflammatory cytokines.     Glutathione-S-transferase (GST) was a sensitive and specific marker for hepatic injury in     several studies before. So the investigator decided to use it as the primary endpoint.     Besides, in our center, there are some liver resection surgeries that didn't need occlusion.     So it can serve the best placebo for determine the the actual effect of dexmedetomidine on     the IR injury in further subgroup analysis.   "
34791|NCT02830360|"     This is a pilot study to determine the feasibility of a larger scale multicenter trial     comparing first line catheter ablation to antiarrhythmic drug therapy for patients with prior     MI, an ICD and VT.   "
34541|NCT02833675|"     Diagnosis of angioedema (AE) is difficult especially in emergency room. Two forms should be     evoked: histaminic AE (allergic or not, which represent 95% of cases) and bradykinic AE     (hereditary or acquired deficiency, with or without C1 Inhibitor) rarer but with more severe     prognosis. The distinction is based on clinical features (spontaneous crisis duration,     presence of concomitant hives, atopic history...). Sometimes it could be difficult to make     the difference. Nowadays, there is no biological marker of the crisis. The search for     biomarkers could improve the diagnostic and therapeutic management of AE. Previous work has     identified targets: D-dimer, C4, and VE-cadherin. We wanted to know the sensitivity and     specificity of these markers.      We conducted a prospective study evaluating the D-dimer assays, complement and VE-cadherin     during an episode of AE. Three groups of patients were tested: bradykinic AE (peripheral or     abdominal attacks), histaminic AE, and abdominal pain (non-bradykinic and non-histaminic     etiology) at the time (day 0) and at distance from the crisis (D7).   "
34542|NCT02833662|"     Higher risk of cardiac and respiratory post-operative events is observed in patients with     unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA     screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia     (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be     compared with the research of arrhythmia, in order to show if they are linked to the     hypoxemia events.      Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory     postoperative complications will be assessed in OSA patients.   "
34582|NCT02833129|"     The purpose of this study is to assess the effect of playing high school football on later in     life cognitive functioning and mental health. This is an observational study that will use     data from the Wisconsin Longitudinal Study to compare high school football playing graduates     in 1957 with comparable non-high school football playing graduates on cognitive functioning     and mental health measures when participants are in their 60s.   "
34544|NCT02833636|"     The age, creatinine, and ejection fraction (ACEF) score has been used to evaluate the     clinical prognostic to patients who underwent PCI. However, it is not known if ACEF score     could evaluate the prognostic of recanalization of non-infarct-related coronary arteries     (non-IRA) chronic total occlusions (CTO) in patients who successful underwent primary PCI.     The objectivity of current study was to assess the prognostic value of ACEF score in acute     ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after successful     primary PCI.   "
34545|NCT02833623|"     Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human     population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate     is low nowadays and patients's compliance is one of the most important effective factors.   "
34547|NCT02833597|"     Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in     arteriopathy when performing rowing on effort.   "
34548|NCT02833584|"     The purpose of this study is to determine whether regular dosage of paracetamol causes     transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.   "
34549|NCT02833558|"     Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat     superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered     problem during submucosal dissection and is usually managed with electrocautery. However,     this does carry a risk of deep thermal injury and perforation.      PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent     adherent barrier when applied to a bleeding point.      The aim of this trial is to study the use of PuraStat® in reducing the need for thermal     haemostasis during ESD.   "
34550|NCT02833545|"     Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single     Center.   "
34551|NCT02833532|"     The purpose of this study is to evaluate non-inferial study of the after using Volus     application, compared to the powerfill.   "
34552|NCT02833519|"     The purpose of this study is to examine the effect of supervised group exercise on mental     wellbeing and signs of depression among pregnant women at risk of perinatal depression in a     randomized controlled clinical trial.      The investigators hypothesis is that 70 minutes of supervised group exercise twice a week for     12 weeks by pregnant women at risk of perinatal depression, will improve the participants     mental wellbeing and reduce their symptoms of depression.   "
34553|NCT02833506|"     This phase I clinical trial studies the side effects of sirolimus and NY-ESO-1 protein with     MIS416 in treating patients stage II-IV ovarian, fallopian tube, or primary peritoneal     cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Vaccine therapy, like Y-ESO-1 protein with MIS416, may strengthen the immune     system to find and kill tumor cells. Biological therapies, such as sirolimus, use substances     made from living organisms that may stimulate or suppress the immune system in different ways     and stop tumor cells from growing. Giving sirolimus and vaccine therapy may work betting in     treating patients with ovarian, fallopian tube or primary peritoneal cancer.   "
34554|NCT02833493|"     The investigators aim to give an overview of Iron overload(IOL) of patients with AA and low     and int-1 risk MDS and their sequelae under different chelation treatment. And the     investigators also aim to evaluate the relationship of LIC and T2*/R2*.   "
34555|NCT02833480|"     This study will evaluate the effects of budesonide (using Symbicort which is budesonide and     formoterol) and fluticasone (using Advair which is fluticasone and salmeterol) on the airway     microorganisms of patients with moderate-to-severe chronic obstructive pulmonary disease     (COPD). This is a randomized, parallel group, two-centered clinical trial study to evaluate     the effects of a 12 week treatment with Symbicort 400 mcg BID and Advair 250 mcg BID (via     Diskus) on airway microbiota in patients with moderate-to-severe COPD. The control arm of     this study will be Oxeze 12 ug BID.   "
34556|NCT02833467|"     Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes     by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate     the feasibility and application value by using NGS into identifying genomic mutations in     multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients   "
34558|NCT02833441|"     Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two     consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be     randomized to a community based peer counseling support group or clinic based standard of     care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the     efficacy of the intervention in improving adherence and virologic suppression.   "
34559|NCT02833428|"     The aim of this study was to analyze using an artificial intelligence engine (IA) the     influence of the pathophysiological environment (set parametric monitoring data, imaging,     biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the     principles of a new approach for studying spinal cord injury patients. It does not meet the     usual criteria of clinical trials in so far as it does not test on patients the effect of a     therapeutic   "
34560|NCT02833415|"     This study is a clinical study to investigate the gluconeogenesis pathway related to visceral     adipose tissue (VAT) in obese individuals without type 2 diabetes and the effects of     empagliflozin (EMPA) on glucose homeostasis in viscerally-obese individuals using functional     studies of glycerol metabolism in hepatic gluconeogenesis using a well-validated nuclear     magnetic resonance (NMR) spectroscopy platform.   "
34562|NCT02833389|"     This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of     repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not     respond adequately to standard wound care. Participants across multiple sites will be     assigned to one of four cohorts (Cohort A, B, C, and D) based on the eligibility criteria and     randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12     weeks in addition to standard wound care.   "
34583|NCT02833116|"     This study evaluate the administration of epidural betamethasone versus dexamethasone for     pain reduction, consumption of analgesic and quality of life. Half of the patient will     receive dexametasone and the other half betametasone.   "
36729|NCT02804919|"     Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user     feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.      Phase 2: To evaluate the CPAP device with communication functionality with data upload.   "
34563|NCT02833376|"     Context: The neuraxial blocks, spinal anesthesia and epidural anesthesia are among the most     frequently performed procedures worldwide, and despite the advancements of medical equipment,     remain dependent on experience and practice of the anesthesiologists. Although antisepsis     takes part of the daily routine, there are still no solid scientific evidence of the most     appropriate antiseptic for these procedures.      Objective: To compare the 70% alcohol and 0.5% chlorhexidine alcohol solution in skin     antisepsis for the neuraxial blocks.      Methods: This is a clinical trial, a prospective, randomized study. There will be selected,     consecutively, 70 patients candidates for neuraxial blocks. Patients will be randomly     assigned to group A (n = 35), in which the antisepsis will be performed with alcohol 70%, and     to group B (n = 35), in which the antiseptic will be performed with the 0.5% chlorhexidine in     alcoholic solution. Samples will be collected with swabs in an area of 25 cm² for bacterial     cultures three times: in pre-antisepsis moments, in the second minute after antisepsis, and     immediately after the puncture. The number of colonies forming units per square centimeter     (CFU / cm²) will be counted. The data will be analyzed statistically.   "
34564|NCT02833363|"     Helicobater pylori plays an important role in the development of gastric cancer. Eradication     therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially     when atrophy and more serious precancerous lesions already happened. Prior studies found the     gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer.     However, they didn't reach an agreement. Correa's model is widely accepted in the development     of gastric cancer. The pathological change makes a more suitable environment for bacteria to     overgrowth. This study are designed to analyze the gastric microbial difference of     non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia     and gastric cancer.   "
34565|NCT02833350|"     This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active     comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and     safety of GDC-0853 in participants with moderate to severe active RA and an inadequate     response to previous methotrexate therapy (Cohort 1) or methotrexate and tumor necrosis     factor (TNF) therapy (Cohort 2).   "
34566|NCT02833337|"     Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are     considered as the most challenging scenarios for implant-supported oral rehabilitation in     modern implant dentistry. Therefore, a comprehensive and precise understanding of such     anatomical structures are needed to avoid potential complications that ultimately might     jeopardize the treatment outcome.      Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such     as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it offers     a viable and reliable tool to study anatomical structures such as the posterior atrophic     maxillae   "
34567|NCT02833324|"     This trial will investigate whether using reminder alarms with a wireless activity tracking     device (Fitbit) will increase daily ambulation in individuals who have just had colorectal     surgery.   "
34568|NCT02833311|"     Maintaining a healthy diet and engaging in routine physical activity may help decrease     severity of symptoms, prevent secondary conditions, and slow functional decline in people     with disabling neuromusculoskeletal conditions. However, people with these conditions face     many health barriers to engaging in healthy behaviors. With the advent of portable     technologies, such as smart phones, tablets and PDAs, there is a need to explore whether     these technologies can help people with disabling conditions to stay motivated and overcome     barriers to engaging in healthy behaviors.   "
34569|NCT02833298|"     Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV)     infection in the United States have advanced liver disease. Patients with advanced     fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are     clinically cured of HCV continue to have an elevated risk of developing hepatocellular     carcinoma (HCC). According to guidelines from several professional societies and from the     American Association for the Study of Liver Diseases (AASLD), in particular, patients with     advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC     whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening     has risen dramatically in recent years due to the confluence of three factors: Increased     screening for HCV, which has allowed more people to realize that they have this often     silent infection; the availability of safe and highly effective direct acting antiviral     drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to     achieve an SVR; and the long duration of HCV infection in many patients, which has allowed     enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in     the era of DAAs and to promote HCC screening, the objective of this study is to conduct a     randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC     screening between patients randomized to either personalized patient navigation or automated     reminders (e.g. electronic or mailed). Both interventions represent improved care over     current standard of care (no patient navigation or automated reminders). There is no evidence     to suggest one intervention is better than the other. Healthcare providers who agree to     participate in the study will be contacted to confirm the liver disease status of their     patients and during the clinical trial the providers of patients in both arms of the trial     will be sent reminders about the need to schedule patients for screening visits.   "
34570|NCT02833285|"     The inflammatory response involves many players from the immune response, including B     lymphocytes. These cells are responsible for the synthesis of immunoglobulins in response to     the presence of an antigen. They are characteristic of chronic inflammation. There are     several subsets of B cells characterized by specific membrane markers. Once activated, these     cells express many factors contributing to tissue destruction seen in periodontitis and     particularly in osteoclastogenesis (receptor activator of nuclear factor kappa-B ligand,     tumor necrosis factor, interleukin-6, macrophage inflammatory protein-1α and Monocyte     Chemoattractant Protein-3).      During the establishment of a periodontal disease, an important inflammatory infiltrate is     observed in the gum. This infiltrate is characterized by the presence of many B lymphocytes.     B cell subsets in the blood and the gum of patients with periodontitis have been little     studied. However, the number of autoreactive B cells (cluster of differentiation (CD)19+,     CD5+) has been reported to be higher in the blood of patients with periodontal disease. In     the gum, the rate of B and T cells increases with the level of inflammation and is correlated     with the severity of the inflammatory process. Activation of B cells is a prerequisite for     the progression of gingivitis to periodontitis. B cell distribution could then be an     indicator of disease progression, but also allow to study the response to treatment.      The aim of this pilot study is to characterize B cell subsets in the blood and the gum of     patients with periodontitis, according to disease activity. Analysis of B cells in the blood     could highlight the association of a particular subpopulation with aggressive periodontal     disease and evidence a particular biological profile of the host response. The investigators     also wish to observe the evolution of this phenotype following an unconventional surgical     therapy.      This study would better understand the pathogenesis of periodontal disease and refine the     diagnosis, prognosis and treatment of periodontitis, and thus participate in the development     of personalized medicine. Biological monitoring of therapeutic effects may be initiated and     allow more effectively prevent recurrence.   "
34584|NCT02833103|"     Sphincter of Oddi dysfunction (SOD) refers to biliary kinetic abnormality of the sphincter of     Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile     duct (CBD) dilation or onset of pancreatitis. Pain caused by SOD affects the quality of life     (QoL).The primary objective of this trial is to evaluate the efficacy of relieving abdominal     pain of Pinaverium Bromide in medication therapy for patients with post-cholecystectomy SOD.   "
34571|NCT02833272|"     Inappropriate medication use among the elderly ranges from 11% to 62% and is a major concern     for patient safety. Benzodiazepines account for approximately 20 to 25% of inappropriate     medications prescribed to the elderly, thus reducing their inappropriate use could have a     substantial impact on patient safety and overall well-being among elderly patients. The     Choosing Wisely Canada- Geriatrics guidelines for high value health care recommend against     the prescription of benzodiazepines or other sedative-hypnotics (Z drugs) in older adults as     first choice for insomnia, agitation or delirium. Despite evidence of potential harms,     benzodiazepines and non-benzodiazepine sedatives (including the Z-drugs: eszopiclone,     zopiclone, zolpidem and zaleplon, henceforth referred to as sedatives) continue to be     prescribed inappropriately to patients in hospital and community settings.      Our primary objective is to facilitate the deprescription of benzodiazepine and     non-benzodiazepine sedative hypnotics (sedatives) using a combination of physician education     sessions and an updated patient educational pamphlet based on Tannenbaum's EMPOWER study     conducted in a community-based setting.   "
34572|NCT02833259|"     From 10% to 30% of patients hospitalized with community-acquired pneumonia (CAP) are     readmitted within 30 days of discharge. These readmissions have negative consequences for the     patients and the hospitals where they are treated, including impaired quality of life,     exposure to hospital-related adverse events, and increased resource utilization.      Risk-adjusted readmission rates can be easily computed and tracked from computerized hospital     discharge data, using validated models. As part of the Hospital Readmission Reduction Program     (HRRP) effective in fiscal year 2013, United States hospitals with higher than expected     30-day readmission rates after pneumonia hospitalization have been subject to financial     penalties from the Center for Medicare and Medicaid Services (CMS). The underlying logic of     the HRRP is based upon the notion that short-term readmission is often a preventable adverse     outcome, reflecting suboptimal quality of care during index hospitalization. Yet, published     evidence suggests that less than one in four all-cause readmissions are deemed avoidable.     Because only avoidable readmissions can be influenced by interventions designed to decrease     readmission rates, avoidable readmission is a more relevant metric than all-cause readmission     for tracking quality of hospital care for pneumonia.      The purpose of this study is to develop an administrative data-based risk prediction model     for identifying potentially avoidable readmissions within 30 days of discharge for patients     hospitalized with CAP.      R3P is a retrospective observational cohort study of consecutive adult patients discharged     from two hospitals with a diagnosis code of CAP. Data sources include routinely collected     hospital discharge data and retrospective chart reviews.   "
34573|NCT02833246|"     This study is being done to determine if sending reminder text messages helps patients take     their Oral Anticancer Medication (OAMs) when they are supposed to.   "
34574|NCT02833233|"     This study is being done to evaluate the safety of combining two strategies called     cryoablation and immune therapy in women with curable early stage breast cancer.   "
34575|NCT02833220|"     The purpose of this study is to determine the effects of TMS on the ANS. The investigator     will determine whether single-pulse TMS of the primary motor cortex in the dominant     hemisphere in healthy, young adults will affect 1) heart rate and heart rate variability, 2)     blood pressure and 3) baroreflex function. This study is foundational in that it will begin     to characterize how single-pulse TMS affects the ANS in healthy adults.   "
34576|NCT02833207|"     The growing population of obese adults is predicted to create a large public health burden in     the next few decades. This study examines function of small blood vessels providing blood     flow to skeletal muscles, to test if younger obese individuals (<40 years old, BMI >30) are     already displaying reductions in blood vessel function. This study will test if the signals     blood vessels use to increase blood flow are changing in these same subjects. Findings from     this study may help create treatments to delay or prevent some of the negative effects of     obesity on vascular health.   "
34577|NCT02833194|"     The primary objective of this study was to evaluate and compare the prevalence of the     following psychiatric pathologies (based on the MINI5.0.0 questionnaire) among 3 groups of     women (Leiden versus aP1Ab-positive versus thrombophilia-negative) with similar obstetrical     histories 10 years after their initial assessment/diagnosis.        -  Mood disorders, including depressive episodes during the previous two weeks, recurrent          depressive disorders at any point in life, dysthymia in the last two years, or any          current or past manic episode;        -  Anxiety disorders, including current agoraphobia, current panic disorders, agoraphobia          with panic disorders, current social phobia, generalized anxiety in the last 6 months,          or current posttraumatic stress syndrome;        -  Apparent psychotic syndromes, including isolated or recurrent psychotic syndromes, past          or present (clinically validated),        -  Current alcohol or drug problems (dependence or abuse).   "
34578|NCT02833181|"     The investigators propose to evaluate circadian variation of EEG using BIS (bispectral index)     monitor in ICU patients in three different groups: non-sedated, only sedated and sedated and     curarized. BIS monitor values as SR (suppression rate), SEF (Spectral edge frequency),     bispectral index and EMG (electromyography) during 24 hours in admitted patients except acute     neurological disease.   "
34579|NCT02833168|"     It is the aim of this project to develop and validate a German language screening     questionnaire for symptoms of respiratory muscle weakness and sleep-disordered breathing     (SDB) in patients with neuromuscular disorders.   "
34580|NCT02833155|"     The purpose of this study is to evaluate the safety and tolerance of entinostat administered     orally as a single agent in a weekly dosing schedule. Additionally, this study will     characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced     breast cancer. And to define the profile of adverse events, including laboratory parameters     in these subjects   "
34581|NCT02833142|"     The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B     and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary     objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess     the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of     BIIB033-A and BIIB033-B.   "
34585|NCT02833090|"     The goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine     (5-HT) in patient with increased severity of aortic stenosis and increased weight cardiac     muscle.   "
34586|NCT02833064|"     Acute liver injury (ALI) and acute liver failure (ALF) are rare clinical conditions, the     latter often associated with a poor outcome. To improve outcomes for these patients,     clinicians need to develop a clearer understanding of the pathophysiology of this condition.     Biomarkers and novel imaging techniques are vital to investigating and understanding the     pathophysiology of ALI. Patients with ALI or ALF aged over 16 and due to any cause will be     eligible to take part in the study. The study will involve collection of biological samples     (blood, urine, stool and breath) from included patients once daily for up to 7 days. For     patients undergoing liver transplantation, a small sample of explanted (removed) liver tissue     will be obtained. A small subgroup of patients with paracetamol induced acute liver failure     will be eligible to be included in a pilot MRI (magnetic resonance imaging) study, which will     involve two MRI scans during the first 7 days of their admission. All patients will be     recruited from the Royal Infirmary of Edinburgh.   "
34587|NCT02833051|"     The purpose of this project is to examine the effects of an acute bout of exercise on     children's energy intake over the course of a day. Previous studies in adolescents and adults     have shown exercise to be effective in decreasing short-term energy intake, with some     variability. Individual characteristics such as habitual physical activity and psychological     factors may influence the effect of exercise on energy intake, but these factors have yet to     be examined. The investigators have assembled a multi-disciplinary team of researchers, with     expertise in eating behavior, exercise, psychology, and clinical research in order to examine     these questions. First, the investigators will examine the difference in energy intake at     lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30     minutes of rest. Second, the investigators will collect objective measures of children's     habitual physical activity, child characteristics (body composition, eating behavior traits),     and individual responses to the controlled exercise bout. The investigators can then examine     both group and individual differences in the energy intake response to exercise. Twenty     children (ages 9-12) will be tested over the course of three visits. The key outcome will be     differences in energy intake in response to exercise vs. rest. Secondary outcomes include the     influence of differences in habitual physical activity, personal characteristics, and     responses to the exercise bout on children's energy intake. The long term goal of this line     of research is to understand the mechanisms behind the interaction between exercise and     energy intake. The translational potential of this research will be to inform personalized     childhood obesity prevention strategies in children at risk for overweight.   "
34588|NCT02833038|"     The primary purpose of this study is to investigate the effect of intravenous magnesium on     blood pressure after Trendelenburg position during robot assisted prostatectomy.      The secondary purpose of this study is to investigate the effect of intravenous magnesium on     pain after robot assisted prostatectomy.   "
34589|NCT02833025|"     Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and     mortality. Clot formation and clot stability are important factors in coagulation and     hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role     in bleeding after cardiac surgery. The primary objective of this study is to evaluate the     relationship between point-of-care determined platelet function and thrombin generation and     postoperative bleeding in infants and young children undergoing cardiac surgery with     cardiopulmonary bypass adjusting for clinically important confounding factors.   "
34590|NCT02833012|"     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of     acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil,     AC-1202, AC-1204, and Axona®.   "
34591|NCT02832999|"     This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes     mellitus patients on oral glucose lowering agents, and naive to incretinomimetic.     Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and     arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day     changes in insulin secretion and insulin sensitivity.   "
34592|NCT02832986|"     Herpes zoster and post herpetic pain are common causes of morbidity in the elderly. Herpes     zoster is caused by reactivation of the virus varicella zoster of latent infection in sensory     ganglia. The acute phase of herpes zoster usually occurs ≤ 30 days after rash onset. However,     the most common complication of herpes zoster is the post herpetic pain, which is usually     defined as a persistent chronic pain for ≥ 3 months after rash onset. The risk of herpes     zoster in life is 25-30%, but this figure rises to 50% among those aged ≥ 85 years.     Similarly, the risk of experiencing post herpetic pain increases with age.      Despite treatment with antiviral drugs, post herpetic pain has been reported in 10-20% of all     patients with herpes zoster, but its incidence increases significantly in elderly patients     over 60 years. It can be particularly harmful when it occurs on a particular field, elderly     multiple pathologies, fragile and with multiple treatment. In this context of decompensation     cascade greatly exacerbate the impact of the initial local disease. Ophthalmologic     involvement is rare but clinically worrisome and generates significant costs.   "
34593|NCT02832973|"     A randomized clinical trial comparing sequential nephron blockage (SNB) with dual blockade of     the renin-angiotensin system (RAAS) plus bisoprolol (DBB) in the treatment of resistant     arterial hypertension (RH) was designed to investigate the importance of the SNB and the     contribution of its volume component versus DBB and the importance of the serum renin in     maintaining BP levels. This randomized trial with two treatment arms could help tailor     therapy by identifying a more effective choice to control hypertension whether by acting on     the control of volume or sodium balance, or by acting on the effects of the RAAS on the     kidney.      Methods - Participants: 80 patients undergoing treatment for RH with losartan (100-200 mg),     chlorthalidone (25 mg), and amlodipine (5 mg) will be randomly divided into two groups after     applying inclusion and exclusion criteria.      Group 1: Sequential nephron blockade (SNB Group) n = 40 Group 2: Dual blockade of the RAAS     plus bisoprolol (DBB Group) n = 40 Intervention: SNB consists in a progressive increase in     sodium depletion. After the administration of a thiazide diuretic (chlorthalidone) and     aldosterone receptor blocker, low doses of furosemide are administered and subsequently     amiloride is prescribed to enhance the natriuretic effect.      The dual blockade of the RAAS plus bisoprolol is used to increase the effect of angiotensin     receptor 1 blockers (ARBs). Therapy then requires sequentially adding an angiotensin     converting enzyme (ACE) inhibitor to reduce the levels of angiotensin (Ang) II resulting from     blockage of the Ang II receptor and then to administer a beta-blocker to decrease the     elevated renin secretion due to both the ACE inhibitors and ARBs Objective: This study, which     compares two antihypertensive treatment regimens in patients with RH, has the following     objectives: to demonstrate the therapeutic efficacy of SNB against DBB in RH patients, and to     assess the side effects and adherence to treatment over 20 weeks of treatment.      Enrollment: The eligibility criteria will follow those shown in the flowchart for the     diagnosis of RH of the First Brazilian Position on RH.      Patients will be excluded if they have: chronic renal failure, atrial     fibrillation/atrioventricular block, contraindication to the drugs that will be used, refusal     or failure to follow the regimen and secondary hypertension.      Follow-up: Patients will be analyzed in five visits at intervals of 28 days for 20 weeks   "
34594|NCT02832960|"     Coronary heart disease (CHD) and heart failure (HF) are the leading causes of mortality and     morbidity, particularly with the current context of an aging population. Prospective cohort     studies, as well as analyses of pooled individual participant data suggest up to a 60-90%     increase in the risk of CHD or HF events among adults with severe SHypo. However, no large     randomized controlled trials (RCT) have assessed the impact of thyroid replacement on     cardiovascular (CV) imaging outcomes. The goals of this proposal are to address the impact of     thyroid replacement on cardiac function. The investigators will conduct a RCT in 185 patients     with subclinical hypothyroidism who will be randomly assigned to thyroxine or placebo with an     average follow-up of 24 months from baseline. The main outcome will be CV imaging modalities     measured by echocardiography at the close-out visit. Assessment of the impact of thyroid     replacement on cardiac function and subclinical atherosclerosis within a trial will aid     decisions and evidence-based guidelines development to treat a potential modifiable risk     factor, such as SHypo.   "
34595|NCT02832947|"     Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8     months after bariatric surgery   "
34596|NCT02832934|"     Coronary heart disease (CHD) are the leading causes of mortality and morbidity, particularly     with the current context of an aging population. Prospective cohort studies, as well as     analyses of pooled individual participant data suggest up to a 60-90% increase in the risk of     CHD or HF events among adults with severe SHypo. However, no large randomized controlled     trials (RCT) have assessed the impact of thyroid replacement on cardiovascular (CV) imaging     outcomes. The goals of this proposal are to address the impact of thyroid replacement on     subclinical atherosclerosis. The investigators will conduct a RCT in 185 patients with     subclinical hypothyroidism who will be randomly assigned to thyroxine or placebo with an     average follow-up of 24 months from baseline. The main outcome will be CV imaging modalities     measured by carotid ultrasound at the close-out visit. Assessment of the impact of thyroid     replacement on subclinical atherosclerosis within a trial will aid decisions and     evidence-based guidelines development to treat a potential modifiable risk factor, such as     SHypo.   "
34597|NCT02832921|"     The primary objective of this program is to apply a virtual reality (VR) cognitive-motor     rehabilitation program to delay or slow cognitive decline of middle-aged adults who have a     family history of Alzheimer's disease (AD) and thus are at particularly high risk of     developing the disease.   "
34598|NCT02832908|"     Brain trauma is an important burden in traumatologic intensive care. In these patients the     treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is     difficult to assess the actual physiopathologic status of the brain. Changing the position of     these patients (semi-seated to lying position) causes changes in the hémodynamics brain     conditions, so in monitoring parameters . The analysis of these changes can givr us valuable     clinically informations.   "
34599|NCT02832895|"     Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial     cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury.     The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral     arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to     detect a segmental lesion on the anterior cerebral arteries (ACA).      The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA.     However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not     been yet determined.      The goal of the present study is to determine the rate of detection of the ACA by using the     FBW in patients with ABI in ICU.   "
34600|NCT02832882|"     In this study, the investigators are going to prospectively compare the clinical outcomes     (technical success rate, 12 month local tumor progression rate, complication rate, tumor     seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique     for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method     with the same device.   "
34601|NCT02832869|"     High quality bowel preparation is essential for successful colonoscopy. This study aimed to     assess the impact of reinforced education by Wechat or short message service (SMS) on the     quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled     study was conducted. Reinforced education groups received additional education via reminders     by Wechat or SMS 2 days before colonoscopy. The primary outcome was the quality of the bowel     preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes     included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective     feelings of patients.   "
34602|NCT02832856|"     This evaluation will test the program effectiveness of a relationship education program     (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on     outcomes of knowledge. It will test 1) whether the Relationship Smarts (RS) Curriculum is     more effective than a control curriculum of job-readiness programming, and 2) whether an     abridged 8-lesson version of the RS Curriculum can be as effective as the full 12-lesson     version.   "
34603|NCT02832843|"     The aim of this study was to elucidate genetic susceptibility of patients with nontuberculous     mycobacterial lung disease using genome-wide association study.   "
34604|NCT02832830|"     The aim of this explorative trial is to verify the comparability of a fractionated intensity     modulated radiotherapy with a conventional radiotherapy related to quality of life on the one     hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as     pain relief and local response for palliative patients with painful spinal bone metastases on     the other hand. This is a single-center, prospective randomized controlled trial with     parallel-group design to determine the quality of life after RT in patients with spinal bone     metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT)     and fractionated conventional external beam RT with 10×3 Gy each.      Experimental intervention:      IMRT 10 x 3 Gy      Control intervention:      3D-RT 10 x 3 Gy   "
34614|NCT02832700|"     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent     colitis and using human in vitro inflammation models. Its use as a food ingredient has proven     safe and with no influence on dietary intake. In a pilot study the investigators found, that     orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine     in active distal ulcerative colitis.      The investigators now wish to evaluate the effects in healthy subjects by studying the     anti-inflammatory and microbiome modulating properties and by assessing possible changes in     gastrointestinal symptoms.   "
34605|NCT02832817|"     Hypoxemia is a frequent situation in clinical practice, particularly in intensive care units     or perioperative. The mortality and morbidity increase for cardiovascular reason, due to     hypoxia has been reported several times. It is therefore important to detect hypoxemia very     early and with accuracy. The objective is to correct the causes quickly and thus avoid or     minimize complications.      In addition to the risks associated with hypoxemia, the monitoring of Arterial Oxygen     Saturation also avoids the adverse effects associated with hyperoxia. Indeed oxygen leads to     the formation of free radicals, which in physiological condition are regulated by antioxidant     mechanisms. However, in anesthesiology, it is common to find pathological situations (acute     respiratory distress syndrome, shock, prolonged inflammatory state) where these regulatory     mechanisms are overwhelmed. Oxygen administration to supra-physiological concentrations leads     to a formation of excessive free radicals, aggravating the existing injury (including lung).      Oxygen therapy is a fully-fledged treatment requiring monitoring of its effectiveness and     tolerance. Currently, the standard method for assessing oxygenation is the arterial blood gas     analysis with the Arterial Oxygen Saturation. Its cost and the need for an arterial blood     sample do not allow regular monitoring. Clinical evaluation of hypoxia is completely     unreliable. there is a third method : monitoring devices that measure Arterial Pulsed Oxygen     Saturation, called pulse oximeters. Pulse oximeters have become an integral and mandatory     part of the standard monitoring. It is through the measurement of Arterial Pulsed Oxygen     Saturation, supposed to reflect Arterial Oxygen Saturation, that clinicians guide their     therapeutic attitudes to optimize oxygenation and improve the prognosis of patients. So pulse     oximetry is a method considered reliable and especially non-invasive. It is less expensive     and does not require blood sampling. These qualities explain why these devices are easily     used in anesthesia, intensive care and in emergency situations.      However, several studies have demonstrated the inaccuracy of Arterial Pulsed Oxygen     Saturation in frequent situations resuscitation (shock, sepsis, dark skin type). Thus, it is     necessary to objectify the benefits and limitations of pulse oximetry to optimize their use,     especially in these situations of high risk, where a discrepancy between the values measured     by the pulse oximetry and measurement of arterial blood saturation with oxygen gas can be     detrimental.      It exists several pulse oximetry devices, whose accuracy seems unequal, which necessitates a     comparative study.   "
34606|NCT02832804|"     To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct     current stimulation (tDCS) in the patients with primary chronic insomnia .   "
34607|NCT02832791|"     The purpose of this randomized study is to compare clinical and functional outcomes of both     surgery techniques for anterior cruciate ligament reconstruction (using quadriceps tendon     versus hamstring tendon) after reconstruction in athletes.   "
34608|NCT02832778|"     The purpose of the study is to measure the drug levels in the blood of HIV-infected     individuals taking anti- HIV medication efavirenz 400 mg once daily in the presence of     anti-TB medication rifampicin and isoniazid. The study is being run in two-stages - London     (Stage 1) and Kampala (Stage 2).      In London (Stage 1): HIV-1 infected patients (without tuberculosis infection) on established     treatment with a combination based on 600 mg efavirenz dose will be recruited.      In Kampala (Stage 2): Patients with both HIV-1 and tuberculosis infection being treated with     600 mg efavirenz combination for HIV AND undergoing TB treatment with a dual therapy regimen     contaning rifampicin and isoniazid will be recruited.      Efavirenz-containing regimens are recommended as first-line therapy for HIV-TB co-infected     patients. It has been shown there is a lack of a significant difference between efavirenz 400     mg and efavirenz 600 mg, indicating that 400 mg efavirenz is non-inferior to the standard     dose.      The advantages of antiretroviral dose reductions may translate into greater benefits for more     individuals infected by HIV globally, since they may allow access programs to reach higher     numbers of infected patients and compensate for the finite global manufacturing capacity and     increasing demand. For efavirenz, significant price reductions have been achieved through     elimination of trade, logistics and manufacturing capacity barriers, and further price     reductions could be achieved with a significant reduction in the cost of pharmaceutical     ingredients. However, no data on the PK and effectiveness of efavirenz 400 mg once daily     during TB treatment has been produced. Given that many patients on Efavirenz- based ART will     need to be treated for TB during their lifetime and rifampicin is one of the most commonly     used treatment for tuberculosis, it is important to study the reduced dose under carefully     monitored conditions prior to roll out of a lower dose standard treatment. Therefore, we aim     to investigate the PK of efavirenz 400 mg once daily in HIV-infected individuals in the     presence of rifampicin and isoniazid in London, UK and in HIV/TB-co-infected individuals on     dual anti-TB treatment in Kampala, Uganda   "
34631|NCT02832479|"     Evolution of medical care for patients with cystic fibrosis appeared in recent years:     prolongation of life expectancy with consequently increased comorbidities and the use of lung     transplantation, systematic neonatal screening of new born since 2002, prescription of     expensive new molecules or new presentation. This evolution justifies to realize an update of     statistics of costs of care and to assess adherence to treatment   "
34609|NCT02832765|"     The primary goal of the study is to determine the local control-rate after radiotherapy (RT)     with and without simultaneous integrated boost (SIB) concepts in patients with bone     metastases of the spine. Further study objectives are survival, and clinical parameters such     as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and     consecutively an increased re-sclerotization of the bone metastasis due to a higher     biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain     relief and mobility.   "
34610|NCT02832752|"     The addition of an Extracorporeal-Cardiopulmonary Resuscitation (ECPR) service to a region     may improve the survival of young patients with sudden unexpected cardiac arrest.The primary     aim of this study is to determine the benefit of the systematic integration of ECPR services     into the out-of-hospital cardiac arrest management algorithm. This study is a controlled     parallel group design with group allocation based on region of treatment. The investigators     will compare the outcomes of ECPR-eligible patients in the intervention region, in comparison     to patients meeting the same criteria in a comparable setting.   "
34611|NCT02832739|"     The aim of the USECARE project is to improve and test SENACA, an ICT-based self-management     support system for chronically ill patients and informal caregivers. 60 end-users will be     instructed to use SENACA for approx. 3 months (in Israel and Norway). Amongst others,     clinical and behavioural outcomes will be recorded. Additionally, SENACA's usability will be     evaluated to determine its potential future scalability.   "
34612|NCT02832726|"     The study investigates the absorption of different doses of hydroxocobalamin and     cyanocobalamin in a vitamin B12-replete Danish population.   "
34613|NCT02832713|"     In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents     35% of cases. It is thought that more than 2.5 million people older than 65 years have knee     osteoarthritis.      Currently, osteoarthritis management is based on three major axes:        1. Non-pharmacological means, such as patient education, loss of weight and physical          activity        2. General pharmacological treatments: mainly paracetamol and then schedule II and III          painkillers as well as nonsteroidal anti-inflammatory agent.        3. Intra-articular pharmacological treatments:             1. Intra-articular injections of corticosteroids: they are recommended during               hydarthrotic flare-ups             2. Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the               absence of intra-articular effusion. However, their efficacy is questioned by most               experts in the case of symptomatic knee osteoarthrosis.        4. Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing          patients, who are sometimes frail, to several peri- and post-operative complications,          the recovery rate (variable according to the prosthesis type and ranging from 5% to 25%          at 9 years) in an ageing population justifies waiting as much as possible before          surgery. Therefore, it is important to test new therapeutic options for symptomatic          osteoarthrosis that will allow postponing the surgical treatment.        5. The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative.          BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the          management of painful reactive periarticular muscle contractures. However, BoNT-A has          also antalgic activity independently of the myorelaxant effect. This allows explaining          in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six          randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections          of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee          osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with          a significant antalgic effect only in the groups treated with BoNT-A. No study has          compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA          in knee osteoarthritis and this is the aim of this trial.   "
34615|NCT02832687|"     Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose     IV acetaminophen on patients' readiness for discharge. In doing so the investigators will     also investigate the various factors that could potentially contribute to a patient's     readiness for discharge such as overall opioid consumption, time to rescue medication,     incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers     and their overall correlation with IV acetaminophen intake.   "
34616|NCT02832674|"     A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and     neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be     enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the     remainder will have a total of 5 study visits.      All subjects will have a single treatment administered. The first 30 subjects will have an     extra visit at Day 60 intended to allow collection of photo images post treatment to be used     for the validation of three blinded raters.      Photo images will be collected using 2D standard photography and 3D using the Vectra system.     The architecture of the skin in the affected area will be measured using the Cutometer, a     suction like instrument that measures elasticity. Sensory and safety will be measured using a     0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration     is approximately 6 months.   "
34617|NCT02832661|"     Biomargin is a European research program aimed at evaluating the diagnostic performance of     biomarkers with respect to renal graft injuries, as well as their prognostic performance with     respect to 3-year and 5-year graft outcomes.      Nucleic acids, proteins and metabolites previously identified as candidate biomarkers of     individual kidney graft lesions will be determined systematically in urine and blood samples     collected in patients from the time of transplantation onwards, as well as in the graft     tissue when biopsies are required for medical causes or performed systematically in the     investigation centres. Their diagnostic and prognostic performance will be checked against     histological reading of the biopsies and evolution of the graft function over time.   "
34630|NCT02832492|"     Previous studies suggest that the stimulus of pupil near response (PNR) may be a conscious     perception of a blurred image. Moreover, PNR is a reflex that can be objectively observed and     with no motor output, suggesting it might be a more convenient index for consciousness     evaluation and consciousness recovery in patients with disorders of consciousness (DOC). We     thus hypothesized that PNR+ patients (patients show PNR during the assessment) would have     better prognosis than PNR- patients (patients fail to show PNR during the assessment).Based     on this hypotheis, researchers will assess pupil near response in patients with unresponsive     wakefulness syndrome (UWS) and compare the prognosis difference between PNR+ patients and     PNR- patients to assess its prognosis value.   "
34618|NCT02832648|"     This research aims to determine whether selenium supplements improve bone and muscle health     in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken     bones).      Osteoporosis is a major public health problem. One in two women and one in five men over age     50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women     with below-average bone density around the time of the menopause might have previously taken     hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side     effects. Therefore there is a need for safe, effective and inexpensive preventative     interventions for women at risk of osteoporosis.      Selenium is a chemical nutrient present in several human proteins, including anti-oxidants.     Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging     reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil,     and so is obtained from many foods. However, soil selenium levels are low in Europe, and     dietary intake in the UK is below recommended levels.      We previously found that women with higher blood selenium levels have stronger bones, but     this doesn't prove that giving selenium will improve bone strength.      The investigators propose a randomised controlled trial to compare selenium supplements with     a placebo (dummy treatment) in women with below-average bone density. The investigators will     give selenium (at two different doses) or placebo to 120 women for six months and use blood     and urine tests and bone density scans to see if giving selenium does have any effect on     bone. The investigators will also do muscle function tests and measurements of free radical     molecules.   "
34619|NCT02832635|"     The purpose of this study is to evaluate the effects on neurocognitive function of     whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of     hippocampus for patients of brain metastases, as well as the feasibility and risk of     avoidance of hippocampus during whole-brain radiotherapy.   "
34620|NCT02832622|"     This is a prospective, multicenter, non-randomized registry/observational study. The study     will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac     Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT     implantation.   "
34621|NCT02832609|"     The purpose of this study is to study the role of closing volume as a determinant of     orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in     closing volume in supine position would be greater in orthopneic than in non-orthopneic     subjects, and (2) the relationship of change in closing volume to change in dyspnea with     position would be dependent on expiratory flow limitation in the sitting position.      In stable obese subjects, in sitting and supine positions, the investigators measured Borg     dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen     expiration test, from which the investigators determined closing volume and closing capacity,     slope of phase III, and opening capacity.      Orthopnea was defined as any increase in the Borg score in the supine position from its value     in the sitting position   "
34622|NCT02832596|"     The arterial blood pressure is thought to affect the ratio between filtration and     reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During     induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the     plasma volume increases. The aim of the study is to evaluate weather a maintained blood     pressure with norepinephrine during anesthesia induction reduces the increase in 125     iodine-labeled human serum albumine (125I-HSA) measured plasma volume.   "
34636|NCT02832414|"     The purpose of this study is to determine if a lifestyle change program for obese patients     who are already receiving continuous positive airway pressure (CPAP) treatment can achieve     weight loss and overall improvement of obstructive sleep apnea syndrome (OSAS).   "
34623|NCT02832583|"     The aim of this prospective study is to assess the efficacy of autologous Platelet Rich     Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin     rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions     4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months     after the last injection session. Safety was assessed by reported adverse event analysis.   "
34624|NCT02832570|"     Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on     treadmill of PAD patients with claudication   "
34625|NCT02832557|"     The goal of this study is to identify miRNAs that are at increased or decreased levels in the     saliva of children with autism spectrum disorder (ASD) or developmental delay and would be     useful biomarkers for the screening of toddlers and young children for ASD. These biomarkers     may allow earlier diagnosis of autism, allowing earlier service, and also help us to     understand some of the changes in the brains of autistic children.   "
34626|NCT02832544|"     This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial     fibrillation (AF)/flutter and stroke.      A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus     standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to     VKA, with testing for superiority if non-inferiority is satisfied.   "
34627|NCT02832531|"     This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial     fibrillation (AF)/flutter and stroke.      A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in     high risk patients either with AF and unsuitable for VKA or without AF and with high risk     factors.   "
34628|NCT02832518|"     The incidence and prevalence of dialysis in Taiwan remains higher as compared to past several     years. The number of dialysis reported about 6-7 million people each year and the 2014     full-year cost estimation was about 330 million NTDs. According to age-standardized     population statistics in 1995, the number of dialysis per million population in 2006 year     were 372.2 people, 381.9 people in 2012 year and the annual growth rate of 0.43 percent     recorded.      EarlySense system is certified by TFDA, FDA and many other countries, which consists of     mainly two parts. One for the sensing element, which placed under the mattress and the other     one is AC-powered display panel bed. This system has the ability to monitor the patients     physiological functions just be in contact via bed. When the patient laid on bed, the sensor     which is placed under the bed would detects heart rate, breathing rate and activity level as     well as other physiological signals. The system is also able to distinguish between patients     in bed and out of bed during the operation to save the patient's records and information     (including heart rate, respiratory rate and level of activity, and may render trends). The     system is also have capability for real-time data transmission information which includes a     warning to the nurses' station or other monitoring center of the screen by providing     real-time information to nurse.      In this research project, we will use EarlySense equipment for continuous monitoring the     dialysis patient's physiological data along with clinical data such as A. acute complications     such as rapid changes in blood pressure, respiratory rate, movements of patients and Nausea     or vomiting, etc phenomenon's) B. Lab examination data C. Status of patient whether patients     hospitalized or not and patient death occurred or not. The study is expected to have a pilot     study for more than three months' duration. Through this EarlySense continuous monitoring and     gather the data, we will analyse to develop a prediction model and confirmed with indicators.     Evidences from these analytics would help to propose ways to improve it and implement     Positive predictive validity models.   "
34632|NCT02832466|"     Patients undergoing haemodialysis present a decrease in physical function, but little is     known about the rate at which function decreases.      The purpose of this study is quantifying the nature and degree of functional deterioration     experienced by stage 5 chronic kidney disease patients during a six month period of     maintenance haemodialysis therapy.   "
34633|NCT02832453|"     The purpose of this study is evaluate the effectiveness of different doses of supervised     exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care     intervention tool for the management of the metabolic syndrome in low active adults with one     or more metabolic risk factors.      Secondary aims of the study are to investigate the effects of these interventions on systemic     inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and     sedentary habits, and the cost-effectiveness of the intervention with regard to health     related quality of life.      The general hypothesis is that adults with risk factors for metabolic syndrome participating     in interventions for the promotion of a healthy lifestyle that together with counselling     strategies will include supervised physical exercise of vigorous intensity will present     greater improvements in terms of metabolic risk, physical condition, physical     activity/sedentary behaviours and psychological parameters at the end of the intervention and     at 6-months follow-up than participants in interventions for the promotion of a healthy     lifestyle that will include counselling plus physical exercise of low-to-moderate intensity     or interventions based exclusively on counselling.      It is a three arms controlled randomized clinical trial implemented in the Primary Health     Care setting and of 10 months duration.   "
34634|NCT02832440|"     Although exercise training of haemodialysis patients is associated with generally positive     outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is     often related to financial cost and/or staffing limitations. Home-based programs could be an     alternative means of providing exercise benefits without associated implementation costs The     aim of this study was to compare the effects of 4 weeks intradialytic versus home based     exercise for haemodialysis patients regarding adherence and strength gains.   "
34635|NCT02832427|"     Although the first outpatient review following cardiac surgery is conventionally scheduled     for six weeks after hospital discharge, there is no evidence to support this practice.     Thirty-day mortality and morbidity rates, which are now widely used as indicators of the     quality of surgical care, reveal rates that are higher than corresponding in-hospital rates.     Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are not     known. The objectives of our study are to determine the postoperative mortality and morbidity     rates in the 6-week interval between hospital discharge and the first planned specialist     review after cardiac surgery, and to assess the level of patient satisfaction with current     practice.      The study will enrol eligible patients who are undergoing elective and urgent coronary artery     bypass and/or valve surgery at our institution over a 6-month period and provide them with     study information. Prior to discharge after surgery, prospective participants will be     consented and given a questionnaire to take home, complete and bring along to the outpatient     appointment.      The investigators will analyse the data to determine the rates and timing of the     complications, and the impact on postoperative recovery. The investigators will also assess     the level of patient satisfaction with the current practice.      Appropriate conclusions either in support of current practice or, a change in practice would     be drawn..   "
34637|NCT02832401|"     Caffeine is the most used psychoactive drug in Canada, with regular consumption by 88% of the     adult population, While rates of caffeine consumption are considered to be high in the     general population, there is some evidence that they may be even higher within schizophrenia     patients; in a 2006 U.S. study, daily consumption rates of caffeine were nearly double those     observed in a healthy control population (471.6 mg/day vs. 254.2 mg/day). Furthermore, 13% of     the schizophrenia population studied ingested more than 1000 mg/day of caffeine, well above     the 400 mg daily maximum recommended by Health Canada. High doses of caffeine are     particularly concerning for individuals with schizophrenia; caffeine alters dopaminergic     activity at post-synaptic neurons through its actions at adenosine A2A receptors, which may     exacerbate positive symptoms, such as delusions and hallucination. This significant rate of     consumption is likely due in part to caffeine's actions on the human brain, resulting in     increased arousal, elevated mood and beneficial effects on a wide-range of cognitive     processes including verbal working memory, sustained attention, and executive function. These     areas of caffeine-induced cognitive improvement notably overlap with the cognitive domains     that are reported to be diminished in schizophrenia. Despite this overlap and the rates of     caffeine consumption observed within schizophrenia, research reports examining the effects of     caffeine on cognition and brain activity are all but non-existent in this population. The     primary objective of this proposal is to compare the effects of caffeine and placebo on brain     function during cognitive tasks in participants with schizophrenia. While the investigators     have specific hypotheses for each task, overall the investigators hypothesize that caffeine     will improve cognitive function (as evidenced by larger ERP amplitudes and/or reduced ERP     latencies) compared to placebo in schizophrenia patients, with similar effects (albeit     reduced in magnitude) observed in non-patient healthy controls.   "
34638|NCT02832388|"     In this study the investigators aim to identify and include all patients with Primary     Aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the     characteristics of these patients, to explore the cardiac effects of PA, and to identify the     long-term patient outcome after treatment. A subgroup of the included PA-patients perform     Cardiac MRI to assess myocardial function in rest and during stress, myocardial mass and     myocardial fibrosis, compared to a group of healthy controls.   "
34639|NCT02832375|"     This single center, comparative design study will be used to investigate the efficacy of an     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity     (DH) after short term use compared with a standard fluoride dentifrice.   "
34640|NCT02832362|"     This will be a single-center, randomized, parallel-group, placebo-controlled study to assess     the local nasal tolerability and safety of multiple administrations of topically     (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult     participants   "
34641|NCT02832349|"     The Epilepsy Patient Education (EPE) is very important for the comprehension of the disease     and its management. The EPE allows patients and caregivers to acquire together some autonomy     and some skills that will help them live better with the disease.The primary objective of     this study is to evaluate the impact of a program of educational activities (EA) on the     quality of life of epileptic patients measured by the validated scale Quality Of Life in     Epilepsy -31 (QOLIE-31).Investigators hope a difference in improving the quality of life     score of 25% between the 2 groups.   "
34642|NCT02832336|"     Caffeine may be playing a beneficial role in patients with narcolepsy. However, the     relationship between caffeine and its effects on narcoleptic patients has not been examined,     and it is also unclear whether caffeine provides a beneficial effect or not. Hence, the aim     of this study is to assess the effects of caffeine consumption on daytime sleepiness and     reaction time in narcoleptic patients.   "
34643|NCT02832323|"     Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through     erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the     hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to     reach this target depends on numerous and imbricated factors such as age, associated     pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO     response and Hemoglobin (Hb) level is currently the only and late tool to assess the     efficacy.   "
34644|NCT02832310|"     The aim of this study is to determine the relation between arterial diameter and flow of     carotis interna, brachial artery and radial artery before and after valsalva maneuver.   "
34645|NCT02832297|"     In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 318     biologic-naïve subjects with RA who are candidates for treatment intensification due to     inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.   "
34646|NCT02832271|"     The purpose of the study is to evaluate the efficacy and safety of green tea in     endometriosis.   "
34647|NCT02832258|"     Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae     (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of     antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal     treatment of E-ESBL is nearly impossible at this time.      Our aim was to describe the characteristics and treatments of urinary tract infections caused     by Extended spectrum betalactamase-producing Enterobacteriaceae in children.   "
34648|NCT02832245|"     The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a     multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive     data registry of consecutive patients with venous thromboembolism.      The main objective is to provide information on the Internet to help physicians to improve     their knowledge on the natural history of thromboembolic disease, particularly in those     subgroups of patients who are usually not recruited in randomized clinical trials (pregnant     women, elderly patients, disseminated cancer, severe renal insufficiency, patients with     contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of     decreasing mortality, frequency of thromboembolic recurrences as well as bleeding     complications and arterial events.      As an additional objective RIETE is also aimed to create predictive scores that help     physicians to better identify patients with high risk of presenting some of these     complications.      The primary parameters recorded by the registry comprise details of each patient's clinical     status, including any coexisting or underlying conditions, and the type, dose, duration and     outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints     are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor     bleeding complications, and death.   "
34650|NCT02832219|"     Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no     studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in     humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators     will evaluate the effects of H2 intervention on body composition, hormonal status, and     mitochondrial function in middle age overweight women, with hydrogen administered orally for     4 weeks.   "
34651|NCT02832206|"     This study evaluates in detail efficacy and safety (including neurological safety) of hybrid     ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF). An     implantable ECG monitor will be implanted to all patients for rhythm monitoring. Neurological     safety will be assessed by cerebral magnetic resonance, neuropsychological examination and     periprocedural transcranial Doppler measurement.   "
34652|NCT02832193|"     Data on how to avoid POCD are limited. The purpose of this monocentric parallel - grouped     observational registry is to collect study data of the incidence of postoperative cognitive     dysfunction (POCD).   "
34653|NCT02832180|"     This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of     child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the     pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and     Norethindrone Acetate.   "
34683|NCT02831790|"     The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of     a novel education program in combination with usual care, versus usual care alone, on     preparing parents of children undergoing Fontan surgery for the challenges of the     postoperative course.   "
34654|NCT02832167|"     The purpose of this study is to determine whether Nivolumab is an effective treatment for     cancer that has advanced or has spread. The study will evaluate the clinical benefit of     Nivolumab in patients at 16 weeks from enrollment. Various tumor types may be eligible for     enrollment. Patients must have received prior standard-of-care treatment for their cancer     before enrollment.   "
34655|NCT02832154|"     This pilot clinical trial studies how well an internet-delivered positive affect (PA)     intervention works in managing emotion in young adult cancer survivors. An internet-delivered     PA intervention may teach younger cancer survivors healthy coping skills and help doctors to     learn more about what effects mood may have on the health and well-being of young adults with     cancer.   "
34656|NCT02832141|"     This pilot study aims to i) represents the feasibility of the study design and ii) to point     out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the     sympathetic nervous system.   "
34657|NCT02832128|"     The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide     an indication of improvement in performance of tests across a battery of speech and hearing     assessments in cochlear implant users.   "
34658|NCT02832115|"     The primary objective of the study is to determine the role of transdermal vasodilators as an     adjunct to parenteral vasodilators in reducing radial artery spasm, improving patient     comfort, and post procedure radial artery patency during transradial coronary angiograms and     interventions. The study hypothesis is that transdermal vasodilators will increase radial     artery size and reduce radial artery spasm as well as improve patient comfort and post     procedure radial artery patency. This is a single-center, double-blind, randomized,     placebo-controlled study comparing the effect of transdermal preparations of lidocaine +     nitroglycerine and lidocaine + placebo on radial artery spasm in patients undergoing     transdermal coronary angiograms. Prior to the procedure, each patient will be randomized into     either the control arm, lidocaine + placebo, or study arm, lidocaine + nitroglycerine.   "
34659|NCT02832102|"     The purpose of this study is to determine new multiscale signatures for the prediction of     head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage     III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for     overall survival.   "
34660|NCT02832089|"     Oral carvedilol administered in escalating doses in patients with atrial fibrillation among     patients with AF with fast ventricular rate.   "
34661|NCT02832076|"     The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed     for 10 days on wound healing in female obese patients undergoing midline exploratory     laparotomies for ovarian cancer.   "
34662|NCT02832063|"     The purpose of this study is to demonstrate the safety, tolerability and efficacy of B244     administered over 12 weeks to participants with mild to moderate acne vulgaris relative to     placebo.   "
34663|NCT02832050|"     Study synopsis Objectives        -  To determine whether delivering a semi-structured play therapy intervention can improve          procedure-related anxiety / ability to cope with a procedure / procedure-related pain          for children and young people.        -  To determine whether delivering a semi-structured play therapy intervention can improve          patient experience of blood monitoring.      Patients        -  Patients aged 5 - 17 years who are under the care of the rheumatology team.        -  Patients expected to require at least two blood tests during a 12 week period. Design        -  Recruitment over 24 weeks with each child in the study for a 12 week period.        -  20 patients will receive play therapy intervention as outlined in the play therapy          intervention for blood tests.        -  20 patients will be the comparator group. They will be offered standard care for blood          tests.        -  All children will be offered local anaesthetic cream for each blood test. Blood tests          will be performed by venepuncture unless specifically requested otherwise by patient.        -  All children will complete outcome measures at baseline, beginning and end of each          procedure session and at completion of the study at 16 weeks.      Outcome Measures        -  Procedure-related anxiety visual analogue scale (VAS) score - completed by child        -  Observer procedure-related anxiety VAS score - completed by parent        -  Procedure-related coping VAS score - completed by child        -  Procedure-related pain VAS score - completed by child        -  Patient experience VAS score - completed by child and parent separately   "
34664|NCT02832037|"     The objective of the study is to investigate the efficacy, safety and pharmacokinetics of     four different doses of BI 425809 once daily compared to placebo given for 12 weeks in     patients with schizophrenia on stable antipsychotic treatment.   "
34665|NCT02832024|"     This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to     Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).   "
34678|NCT02831855|"     This study is designed to evaluate the efficacy and safety of tofacitinib modified release     formulation (11mg QD) versus tofacitinib modified release formulation plus continued     methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are     insufficiently responding to their stable dose of methotrexate treatment.   "
34666|NCT02832011|"     This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged,     below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin or     olive-oil fortified breast milk. Cases will receive same amount of calorie intake either with     eoprotin or olive oil fortified-breast milk. If investigators identify that olive oil doesn't     increase proinflammatory cytokines and grant enough weight gain in premature infants at the     end of the study, investigators will suggest olive oil to replace eoprotin which is a very     costly breast milk-fortifier.   "
34667|NCT02831998|"     The objective of the study is to demonstrate the antimicrobial efficacy of the ZP     Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.   "
34684|NCT02831777|"     The goal of the study is to test the capability of the CareTaker monitor to calibrate its     continuous blood pressure readings independently. Currently the device requires another     approved blood pressure monitor to provide a starting calibration.      The new control module enables the CareTaker to perform a pressure sweep of the internal     pressure in the finger cuff. The resulting data is analyzed using a combination of pulse     analysis/oscillometry approach.   "
34720|NCT02831309|"     ACS examined the potential influence of intermittent physical activity breaks of various     intensities (control, light, moderate, vigorous) on measures of immediate mental performance,     mood, hunger and several metabolic outcomes in children aged 7-11 years. We build upon     previous work to hypothesize that higher-intensity intermittent physical activity breaks     throughout an 8-hour day will improve immediate mental performance, mood, and post-exercise     physical activity levels, while reducing hunger and post-exercise food intake.   "
34668|NCT02831985|"     A large number of children with otitis media undergo surgery with ventilation tubes (VTs)     placed in the tympanic membrane. This is done to improve hearing and speech development and     to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is     required to assure that the tubes are functional, hearing loss has been corrected, and     potential complications are properly diagnosed and managed. Guidelines regarding follow-up     care give different advices concerning when, how and by whom the controls should be made.      The primary goal of this study is to investigate if follow-up care after surgery with VTs of     children aged 2-12 years can be done by general practitioners instead of specialists without     negative consequences for the patient.      In the study the child`s hearing and speech development, middle ear function, subjective     complaints and complications will be assessed. User satisfaction and other aspects related to     the quality of control will also be assessed.      If the study shows that follow-ups after surgery with VTs can be done on the level of primary     care without loss of care quality, specialist health care services will be spared and     cost-effectiveness for the overall healthcare system will improve.   "
34669|NCT02831972|"     An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses     of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects.     Period 1 consists of a single oral dose of AG-120 will be administered at Hour 0 followed by     PK sampling for 504 hours (21 days). In Period 2, multiple oral doses of itraconazole will be     administered once daily (QD) for 18 consecutive days with a single oral dose of AG-120     coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21     days) following AG-120 dosing on Day 1.   "
34670|NCT02831959|"     The study is a prospective, randomized controlled phase III trial, to test the efficacy,     safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic     radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to     supportive treatment alone. The device is an experimental, portable, battery operated device     for chronic administration of alternating electric fields (termed TTFields or TTF) to the     region of the malignant tumor, by means of surface, insulated electrode arrays.   "
34671|NCT02831946|"     To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at     cesarean section (CS) on long-term cosmetic and maternal outcome.   "
34672|NCT02831933|"     This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and     stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before     nivolumab in patients with metastatic squamous and non-squamous non-small cell lung carcinoma     (NSCLC). In situ gene therapy will consist of adenovirus-mediated expression of herpes     simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy.   "
34673|NCT02831920|"     The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic     biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the     one hand and underdiagnosis and undergrading of significant PCa on the other. multiparametric     Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the clinics for biopsy     targeting, but the value in biopsy naive patients remains controversial. With Contrast     Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the     potential to improve ultrasound imaging for prostate cancer detection and localisation     significantly. The past years numerous studies have been performed with CEUS, all basing     their results on subjective judgement of the investigator. To overcome these difficulties     CEUS quantification techniques have been used with encouraging first results. These imaging     techniques have been proposed to improve the yield of prostate biopsies and possibly     replacing systematic biopsies.      In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy.     Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS     lesions, together with standard systematic biopsies in the same patients by separate blinded     clinicians. The main outcome measure is the per-patient (significant) prostate cancer     detection rate for each of the biopsy regimens.   "
34674|NCT02831907|"     The purpose of this study is to evaluate the possible association between portal vein flow     pulsatility and acute kidney injury after cardiac surgery. Participants will undergo     assessment of portal vein flow and intra-renal blood flow using bedside Doppler ultrasound     before surgery and daily for three days after cardiac surgery.   "
34675|NCT02831894|"     Treatment-seeking insomnia sufferers most often present in primary care venues where the     first and usually only treatment is a prescription for a sedative hypnotic, typically a     benzodiazepine (BZD) or newer benzodiazepine receptor agonist (BzRA). For some patients,     short-term or intermittent use provides satisfactory insomnia relief. However, more than 65%     of individuals who are prescribed hypnotics use them for more than a year, and > 30% remain     on these agents for more than five years. Whereas some patients may appreciate partial or     full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these     agents may not represent optimal therapy. A sizable proportion of insomnia patients who     participate in non-drug insomnia therapy such as cognitive behavioral insomnia therapy     (CBT-I) achieve sustained insomnia remission long after a time-limited course of treatment.     However, it is difficult for most long-term hypnotic users to convert from use of medications     to a self-management approach. Interventions that combine CBT-I with supervised medication     tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50% of     patients who receive this assistance either fail to discontinue their hypnotics or return to     them even if they do achieve short-term abstinence. Previous research provides only a     rudimentary understanding of how to help long-term hypnotic users discontinue their sleep     aids and successfully manage their insomnia with CBT-I techniques.      Limitations of existing research include failure to consider how:        1. the pace of hypnotic withdrawal influences outcomes;        2. patient characteristics such as belief in the need for sleep medications, and anxiety          sensitivity moderate outcomes; and        3. hypnotic withdrawal symptoms and changes in sleep quality mediate outcomes.      This R34 project will gather key pilot data to address these limitations. Specifically, this     project will compare the currently recommended tapering pace (25% dose reduction every two     weeks) to a slower tapering pace (10% dose reduction every two weeks) and a no tapering     condition to determine the influence of tapering pace on outcomes. The study also will     examine participants' beliefs about their need for hypnotics, anxiety sensitivity, and     hypnotic dose, half-life and time used as moderators of outcomes. The influence of hypnotic     withdrawal symptoms and level of sleep disturbance during withdrawal will be tested as     mediators of outcomes. Enrollees (N=75) will first complete CBT-I and then will be randomized     to a tapering pace (n=25 per SMT pace). Target moderators and mediators will be examined to     assess their influence on outcomes. Primary outcomes will include drop-out rates and hypnotic     discontinuation rates observed for each SMT pace. Investigators will tally rates of those who     achieve hypnotic dose reductions during SMT and those who return to hypnotic use by a 3-month     follow-up as secondary endpoints. Results will inform a future R01-level clinical trial     focusing on tapering pace, patient characteristics that moderate the effect of tapering pace,     and psychophysiological processes that mediate the effect of tapering pace. This line of     research will inform clinical practice by helping to refine guidelines for tapering pace so     as to provide more successful, person-centered interventions   "
34676|NCT02831881|"     A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non     Emergent High Risk PCI patients.   "
34677|NCT02831868|"     To determine the safety, tolerability and efficacy of the HAVAI device as a minimally     invasive double anchor and suture orthopedic implant fixation device for IMA reduction in     cases of HV deformities when the IMA is greater than 120 and less than or equal 200.   "
34679|NCT02831842|"     This non-interventional study will meta-analyze overall survival outcomes among the     participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat     sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with     bevacizumab containing treatment regimen in routine clinical practice. The study leveraging     secondary data from existing cohorts in the United Stats of America (USA), Germany,     Australia, and Denmark.   "
34680|NCT02831829|"     The aim of the study is to compare the effect of water-based and land-based exercise     training, and usual care (no exercise training) in patient with coronary artery disease, on     exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic     function, and markers of neurohormonal activity, activated hemostasis and inflammation.   "
34681|NCT02831816|"     The objective of the study is to demonstrate the antimicrobial efficacy of the ZP     Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.   "
34682|NCT02831803|"     This study is designed to test the feasibility of asking older adults with high blood     pressure to supplement their daily diets with walnuts and extra-virgin olive oil.   "
34685|NCT02831764|"     This study will compare safety, efficacy, and tolerability of a two drug regimen of     dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two     nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate     [TDF]/emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human     immunodeficiency virus (HIV) 1 infected adult subjects that have not previously received     antiretroviral therapy. The study is designed to demonstrate the non inferior antiviral     activity of DTG + 3TC regimen to that of DTG + TDF/FTC FDC and will characterise the long     term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148.     Approximately, 700 subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC.     Subjects will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and     by screening CD4+ (cluster of differentiation 4) cell count.   "
34686|NCT02831751|"     This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the     immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The     study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP     Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria     and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine     is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The     study will also help to define the optimal dose in this population, establish potential     competitive advantages, and support the design of future studies.   "
34687|NCT02831738|"     Primary outcome measure: Changes in plasma glucose concentration over a 3 hour postprandial     visit after administration of polydextrose (12g) compared to 0 mg placebo.      Secondary outcome measure: Changes in gastrointestinal tolerance and acute bowel changes in 3     days following treatment administration.   "
34688|NCT02831725|"     1. Demographics data;        2. Nutritional evaluation data;        3. All biochemical monitoring data during the study period;        4. All nutritional treatment data will be recorded daily during the study period, including          actual calorie intake, protein intake, and the proportion of calorie/protein          administered by EN and/or PN route. The nutritional treatment protocol will be decided          by the attending physician, the investigator will not intervene.        5. A blood sample (5 ml) will be drawn from every patient immediately after they enroll          into the study, and the metabolomics of the samples will be analyzed analysis using a          combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish          metabolic profile baseline.        6. We will establish a sub-group that contains 20 patients (chosen from enrolled patients          according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take          one blood sample daily during the whole study period. The plasma sample will be used for          metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used          for metabolic dynamic modeling.        7. Clinical outcomes data, which include: 1) Complications after the operation (intestinal          fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial          infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization   "
34689|NCT02831712|"     This study aims to investigate a possible effect of iron status on temporary build-up of     non-transferrin bound iron (NTBI) in healthy volunteers upon iron supplementation.   "
34690|NCT02831699|"     This study will evaluate subjects with fever and/or rash to determine the percentage of those     infected by the Zika, Chikungunya, or Dengue virus. The study will also compare the clinical     signs, symptoms, and lab abnormalities related to each virus, to better specify each virus's     characteristics.   "
34693|NCT02831660|"     The objective is to collect the safety data of idarucizumab for patients treated with     dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of     uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are     required.   "
34694|NCT02831647|"     Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE   "
34695|NCT02831634|"     Feasibility study for a method allowing identification of tumor mutated epitopes in patients     with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for     these tumor neo-antigens in their lymph nodes   "
34719|NCT02831322|"     Several approaches have been proposed to reduce the risk of RAO, including anticoagulation,     immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler     ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal     end rather than distal part of the artery,which was ignored by a majority of interventional     cardiologists. Different insights into occlusion location may lead to different options of     sheath materials, models, catheters and puncture access. Thus, the investigators designed     this present study to explore the reason of radial artery endothelial dysfuction and damage     and occlusion location by ﬂow-mediated dilation (FMD) to determine the suitable method to     reduce occlusion risk during TRI.   "
35181|NCT02825290|"     This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with     modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of     ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone     only in ovulating women.   "
34696|NCT02831621|"     Excess ectopic fat deposition is associated with development of cardiovascular and metabolic     diseases. This study investigates how lifestyle interventions can have an effect on different     sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the     clinical and economic value of exercise to supplement a hypocaloric diet is investigated.      Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women     during consultations. Also, recruitment posters will be used in the University Hospital of     Antwerp and the University of Antwerp. Potential participants meeting all a priori set     inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric     diet group (usual care) or a group of hypocaloric diet combined with physical fitness     training. Both groups will undergo an intake procedure in which personal goals are set and     barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by     imaging techniques after three and six months of intervention. A post-intervention follow-up     period of six months is planned. Based on the known relationship between ectopic fat and     cardiovascular outcomes, the short term study results will then be extrapolated to an     estimation of the reduction of cardiovascular events.      The following clinical outcomes will be presented: change in ectopic fat in the abdomen     (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids),     heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The     impact of supervised exercise in addition to diet will be expressed in projected healthcare     costs and quality adjusted life years.   "
34697|NCT02831608|"     Background. For more than a century a causal link between influenza and cardiovascular     disease has been suspected. It is conceivable that influenza may precipitate plaque rupture,     increase cytokines with central roles in plaque destabilization and trigger the coagulation     cascade. Accordingly, registry studies, case control studies and a few small randomized     trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute     myocardial infarction (AMI) is increased following respiratory infection and that the risk of     stroke and AMI in patients with established cardiovascular disease seem to be reduced     following influenza vaccination. In May 2015 a Cochrane review concluded that influenza     vaccination may reduce cardiovascular mortality and cardiovascular events but bias and     inconsistent results in prior studies require higher-quality evidence to confirm these     findings. High costs and little commercial interest in conducting a randomized trial on     influenza vaccine in cardiovascular disease stand in the way.      Objective. The objective is to document whether influenza vaccination protects against     cardiovascular events and death after an AMI.      Methods. Population: 4400 patients with ST-elevation (STEMI) or non-ST elevation myocardial     infarction (NSTEMI) are randomized 1:1 in a blinded fashion using an RRCT design and followed     up via registries and two telephone calls. Intervention: Influenza vaccination. Control:     Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial     infarction and stent thrombosis till 1 year in patients with STEMI/NSTEMI undergoing coronary     angiography/PCI. Patients will be included in the study in all of Sweden's 8 university     hospitals, 3 university hospitals in Denmark, 1 in Finland, 1 in Iceland and in 1 specialized     heart center in Norway. Secondary endpoints are time to all-cause death, time to stent     thrombosis, time to revascularization, time to myocardial infarction, time to stroke or time     to rehospitalization for heart failure till 1 year, 2 years, 3 years and 5 years.     Furthermore, an extensive health-economic analysis will be conducted. The trial has been     approved by the ethical committee system (Dnr 2014/264) and the Medical Products Agency     (EudraCTnr -2014-001354-42) in Sweden.      Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza     vaccination may become an important novel in-hospital therapy for patients with     cardiovascular disease and the accompanying direct and indirect societal gains will be     profound. IAMI will be the first placebo-controlled RRCT conducted.   "
34698|NCT02831595|"     Modern knee implants combine several types of metal and therefore potentially expose patients     to different metal ions.      Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion     process and the metallic ions release towards the surrounding biologic environment, thus,     making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.      The aim of the study is to verify that the postoperative plasma metal concentrations at 1     year are not different than preoperative values.   "
34699|NCT02831582|"     This clinical trial studies the use of omega-3 fatty acid supplementation in preventing     aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3     supplementation may help relieve moderate to severe bone pain and improve joint symptoms     caused by aromatase inhibitor-induced arthralgias.   "
34700|NCT02831569|"     This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of     loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients     with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated     with muscle strain. More than 90 patients will be screened to enroll approximately 80     patients in the trial.      After giving written informed consent, patients will be enrolled in the trial. Patients who     are considered eligible for the trial by the Investigator after consent and complete the     trial procedures and assessments at Visit 1 will receive the trial medication and enter the     open-label treatment period of 2 weeks. Patients who complete the open-label treatment period     will enter the follow-up period of 1 week and complete the trial after confirmation at the     last visit (or phone interview).   "
34701|NCT02831556|"     Summary        1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid          acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images.          The study will use a newly developed acquisition method and post-processing technique to          create three dimensional image models of the abdomen and/or pelvis.        2. Study activities and population group. The study population will be a convenience sample          of patients of any age presenting to the Emergency Department with complaints          necessitating a clinical abdominal and/or pelvic imaging. The study intervention          includes acquisition of research ultrasound images, which will not be used for clinical          care, and comparison of these images with clinically obtained images. Other clinical          data such as surgical and pathology reports will also be reviewed. 3.Data analysis and          risk/safety issues. This is a pilot study intended to determine feasibility and to          refine image reconstruction algorithms. Research images will be compared to clinical          images. Comparison of research images with final diagnosis will also occur. The research          intervention, an ultrasound exam, has no known safety risks. The only risk to subjects          is loss of confidentiality.      This study is observational, not interventional, because the experimental ultrasound will be     performed in all subjects and will not be used in the clinical care of patients     (consequently, will not have the opportunity to affect clinical outcomes). Experimental     images will be reviewed after completion of clinical care and will not be provided to the     clinicians caring for the subjects. The investigators are not measuring the effect of the     ultrasound examination on the subjects' outcomes.   "
34702|NCT02831543|"     A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical     trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in     functional dyspepsia patients.   "
34703|NCT02831530|"     Cyclins CDK4 / 6 are extensively involved in the proliferation and growth of numerous cancers     including breast cancer. The objective of this study is to identify if a new preoperative     oral treatment, abemaciclib directed against the CDK / 6 compared to no treatment, inhibits     tumor growth or induced senescence (aging) tumor.      This early study is offered to women who are going to be operated on for breast cancer with     expression of hormone receptor (ER and / or PR). These women will have 3 chances to receive     one for up to 14 days in the waiting period of their surgery abemaciclib as tablets. Other     patients do not receive treatment. The decision to receive or no treatment will be done by a     random computer draw.      The drug's effectiveness will be evaluated primarily on the biological parameters of the     tumor itself when comparing surgery to before treatment. These results biomarkers will allow     us to better know how this treatment and eventually will be used in future to identify     patients for whom treatment with abemaciclib more efficiency.      Patients treated in the protocol will then receive treatment entirely conventional in their     breast cancer within the parameters of their tumors: their participation is very limited in     time.   "
34704|NCT02831517|"     The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of     BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants;     and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy     Japanese participants. The secondary objective of this study is to assess the safety and     tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian     participants) and as repeated oral doses (Japanese participants).   "
34705|NCT02831504|"     PhenoDM1 will use patient reported outcomes to assess levels of pain, fatigue and quality of     life in this cohort. Clinical and functional outcomes will look at muscle wasting and levels     of myotonia. DNA, RNA, serum and CSF samples will be taken from all patients so that     additional genetic and molecular biomarker analysis can be carried out. A subset of patients     will undergo detailed sleep studies along with skeletal muscle MRI of the lower limbs. This     study will complement the work of other groups currently looking at myotonic dystrophy type 1     using the same outcomes and measures where possible.   "
34706|NCT02831491|"     The main purpose of this study is to evaluate the safety of the study drug ramucirumab in     combination with weekly docetaxel in participants with stage IV non-small cell lung cancer     (NSCLC) following disease progression after prior platinum-based chemotherapy.   "
34707|NCT02831478|"     To assess the safety of a sunscreen product under supervised outdoor-use conditions with the     target consumer   "
34708|NCT02831465|"     Maximal Voluntary Ventilation (MVV) correlates well with maximal exercise capacity and is     used to assess the ventilatory function during exercise in COPD (Chronic Obstructive     Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and     is believed to be due to expiratory flow limitation.      The present study is intended to assess whether DH can also occur during MVV in normal     subjects without expiratory flow limitation.   "
34709|NCT02831452|"     The aim of this study is to determine if there is a correlation between digital palpation,     perineometry and dynamometry as PFM function evaluation methods in nulliparous without pelvic     floor dysfunction.   "
34710|NCT02831439|"     The goal of this project is to examine the effectiveness and potential cost savings of two     organizational interventions aimed at reducing the use of ineffective or unproven care among     women with incident breast cancer.   "
34711|NCT02831426|"     The rationale for present trial conception and design moves forward from the assumption that     a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is     feasible, safe and giving rewarding results when compared to the standard retro-pectoral     technique. Ahead of that, the trial aims to test if there is a difference in the outcomes     between a biological and a synthetic material when placed as a support under the mastectomy     skin flaps, both in terms of immediate complications and of long-term results.   "
34712|NCT02831413|"     This project will test the effectiveness of offering healthy marriage and relation education     for youth as part of the regular school curriculum and examine whether providing enhanced     training and support for facilitators shows promise for enhancing the effects on high school     students. The evaluation will examine a range of students' relationship outcomes, including     their attitudes toward relationships, their knowledge of healthy relationships, their     communication skills, and the characteristics of their current relationship.   "
34713|NCT02831400|"     The purpose of this study is to detect changes in circulatory I-FABP values (50% increase) in     elderly volunteers following the combination of moderate physical activity and a standard     meal.   "
34714|NCT02831387|"     The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye     Symptoms.   "
34715|NCT02831374|"     Purpose: This prospective randomized comparative clinical study was conducted to assess the     effect of platelet-rich plasma (PRP) gel on soft tissue healing and bone regeneration     potential on lower third molar extraction sockets.      Methods: For the study, 50 Patients (37 male, 13 female) requiring surgical removal of a     lower impacted third molar and who fulfilled the inclusion criteria were recruited. The     patients were categorized into two groups, Group A and Group B. For each group 25 patients     were randomly allocated. The predictor variable in Group A was the application of PRP Gel     whereas in Group B had no PRP. Postoperative pain, swelling, trismus, soft tissue healing and     osseous regeneration was assessed using standard methods. These outcome variables were     assessed on 1, 3-, 5-, 7-, and 14-postoperative day. Patients were recalled at the 4th, 10th,     and 16th postoperative week for assessment of bone healing. The data were recorded and     tabulated.   "
34716|NCT02831361|"     The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg     orally administered once daily for 24 weeks compared with placebo in patients with type 2     diabetes mellitus who have inadequate glycemic control on insulin alone or on insulin in     combination with metformin stably for 8 weeks.   "
34717|NCT02831348|"     This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with     inflammatory and non-inflammatory conditions.   "
34718|NCT02831335|"     The purpose of the study is to investigate the associations of the age-related changes in the     brain, kidneys and cognitive performance in healthy adults by utilizing multiple anatomic and     functional MRI methods along with a battery of cognitive tests.   "
34721|NCT02831296|"     SPOT SMA is a prospective NIH-supported clinical study targeting pre-symptomatic or recently     diagnosed infants and children with Spinal Muscular Atrophy (SMA) types 1, 2, or 3 and their     healthy control siblings less than 36 months of age at the time of study enrollment. The main     objective of the study is to prospectively collect longitudinal clinical outcomes and provide     counseling and education to parents of newly diagnosed children. The study will assess the     impact of current standard of care management paradigms and interventions on health outcomes     in newly diagnosed SMA infants and children with type 1, 2 or 3 and age appropriate controls.     There is no investigational drug and no specific intervention in this study. Rather, the     investigators will document outcomes related to current therapies provided to participating     subjects, and will educate participants about possible clinical trial opportunities.   "
34722|NCT02831283|"     This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A     type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal     accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in     the brain. These are thought to be involved in Alzheimer's disease. The investigators will     also perform brain MRI and do tests to measure the participants' memory and thinking.   "
34723|NCT02831270|"     Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's     outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential     procedure for cardiac surgery, dilutes patient's blood components, possible impact of     applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well     investigated.      In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years,     n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients     (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage and     administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be     started at 30 min after anesthesia induction and before CPB application for surgery. In both     groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming     solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr will be     determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the second ANH     of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5), immediately and 1     hour after the weaning from CPB (T6, T7) and at the end of surgery (T8). S-Cr will be     determined by using a point-of-care test device (StatSensor™ Creatinine, Nova Biomedical,     USA).   "
34724|NCT02831257|"     The goal of this clinical research study is to learn if the study drug AZD2014 can shrink     growing or symptomatic meningiomas.   "
34725|NCT02831244|"     The purpose of this study is to evaluate the performance of the Agili-CTM implant in the     treatment of osteoarthritis of the Great Toe.   "
34726|NCT02831231|"     This study is intended to determine whether the addition of trospium chloride to xanomeline     tartrate will ameliorate the peripheral cholinergic side effects that have been previously     experienced with xanomeline tartrate when administered alone.   "
34727|NCT02831218|"     The purpose of this study is to compare clinical outcomes between QCA(quantitative coronary     angiography)-guided and imaging-guided strategy in patients with native coronary artery     disease undergoing Bioresorbable Vascular Scaffold implantation.   "
34728|NCT02831205|"     The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is     non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion     failure (TLF) at 1 year.   "
34729|NCT02831192|"     The purpose of this study is to see whether HLA-mismatched donor cells infusion with     chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve     survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a     prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and     toxicities.   "
34730|NCT02831179|"     This phase I trial studies the side effects and best dose of veliparib when given together     with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has     spread to other places in the body and usually cannot be cured or controlled with treatment,     has returned after a period of improvement, and cannot be removed by surgery. Veliparib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading.   "
34731|NCT02831166|"     Primary percutaneous coronary intervention represents the gold standard for the treatment of     ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are     associated with an increased risk of mortality, re-infarction, and stroke. Although the     prognostic value of access site related bleeding complications is still debated, transradial     approach is associated with better short-term outcomes and reduced hospital stay as compared     to transfemoral approach. The investigators aimed to compare transradial approach with     transfemoral approach with systematic achievement of hemostasis by the implantation of a     vascular closure device in a national multicentre randomized clinical trial.   "
34732|NCT02831153|"     This study evaluates the effects of emotional status on coronary flow in patients undergoing     elective coronary angiography. Patients whom undergoing elective coronary angiography will     fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory,     Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled both before     the intervention and after 1 hour the patients learned the results of the coronary     angiography. The other scales will be performed after 1 hour the patients learned their     results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial Infarction) frame     count method.   "
34733|NCT02831140|"     This prospective, randomized study is designed to evaluate the effectiveness of postoperative     care pathway using the Fast Track Rehabilitation protocol (FTR) in comparison with the     traditional postoperative care.      In order to conduct this study, patients having a thoracic surgery will be randomly     attributed to FTR protocol group or control group.   "
34734|NCT02831127|"     Plastic and covered metal stents need to be removed or exchanged within appropriate time in     case of undesirable complications. However, it is not uncommon that patients does not follow     the recommendation for further stent management after ERCP. we hopothesized that short     message service (SMS) intervention monthly could improve the adherence in patients with     benign pancreaticobiliary after ERCP.   "
34735|NCT02831114|"     Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane     chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is     difficult and at this time conventional treatment is primarily limited to the global use of     antidepressants and anticonvulsants. Acupuncture treatment has been used for symptom     improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus;     however, few studies have evaluated acupuncture as a viable treatment for taxane induced     peripheral neuropathy. This study will enroll female breast cancer survivors at the     Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to     assess whether acupuncture holds any therapeutic benefit for TIPN and how it influences the     mechanisms underlying resolution of TIPN. This would provide critical validation of     acupuncture and increase potential for other forms of chemotherapy induced peripheral     neuropathy.   "
34736|NCT02831101|"     We compared BIS values during propofol stepwise induction with or without concomitant     sufentanil in patients ≥ 65 years .   "
34737|NCT02831088|"     Efficacy and safety of Neu2000, a multi-target drug designed to prevent both NMDA     receptor-mediated excitotoxicity and free radical toxicity, will be investigated in acute     ischemic stroke patients receiving endovascular treatment to remove clot within 8 hours     following stroke onset. Neu2000KWL will be administered before endovascular treatment.   "
34738|NCT02831075|"     Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This     study intends to establish an optimal clinical research program, and attempts to break the     technical bottleneck in the stem cell therapy for treating diabetes related vascular     complications.   "
34739|NCT02831062|"     This study will evaluate patients who have an episode of moderate to severe acute kidney     injury (AKI) and are followed in a focused post-AKI clinic. After patients present signs of     kidney recovery and before hospital discharge, patients who give consent will be enrolled in     the study. At the first post-AKI clinic visit, patients will be randomly allocated to follow     a normal (ad-lib) or a low protein diet (LPD) for 3 months. Patients allocated to a LPD will     receive a drug called Ketosteril. This drug allows the intake of essential amino acids while     minimizing the amino-nitrogen intake, what in excess, can be bad for the recovered kidney.     The investigators will evaluate the nutritional parameters and the kidney recovery of all     patients and compare these parameters in those two groups.   "
34740|NCT02831049|"     Background:      Sights, sounds, and smells can be associated with alcohol and tempt people to drink. The     connection between encountering cues and wanting to drink might be reduced by behavioral     techniques, like giving the cues at certain times, in certain circumstances.      Objective:      To see if visual imagery and behavioral techniques can reduce alcohol craving and drinking.      Eligibility:      Healthy people ages 21 65 who are mildly concerned about their drinking and have had these     habits in the past 3 months:      Women: More than 3 drinks any single day and more than 7 drinks per week      Men: More than 4 drinks any single day and more than 14 drinks per week      Design:      Participants will be screened with medical history, physical exam, blood tests, alcohol     breath tests, hepatitis tests, and alcohol and drug use questionnaires.      Participants will get a smartphone to carry throughout the study. They will use it to report     on their drinking, moods, and activities daily. The phone s GPS will record their locations     throughout each day.      There will be 6 study visits over 4 weeks. Visits will last up to 4 hours, but the final     visit lasts up to 7 hours. Visits include the following:      Not drinking alcohol or using illicit or over-the-counter drugs at least 24 hours before each      visit      Providing urine and breath samples.      Exposure to various cues. Participants reactions will be monitored by measuring heart rate,      blood pressure, and skin temperature.      Drinking alcohol or soft drinks. For visits with alcohol, transportation to and from the      visit will be provided.      About a month after the last visit, participants will be called to ask about their drinking     and cravings.   "
34741|NCT02831036|"     20 healthy man, 10 in trial group and 10 in control group (randomly divided) will participate     in the experiment on order to evaluate if improvement in physical fitness influences spatial     learning in humans.   "
34742|NCT02831023|"     The purpose of this study is to determine the most efficacious transmission blocking drug     regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be     the proportion of mosquitoes infected pre and post-treatment, assessed through membrane     feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary     endpoint will be a within group comparison between the mean of the pretreatment infectivity     (Day 0) and infectivity at 7 days post first dose.   "
34743|NCT02831010|"     The purpose of this study is to explore the perinatal risk factors of encephalopathy of     prematurity and the morbidity of the following neurodevelopmental impairments in preterm     infants with gestational age <32 weeks in China.   "
34744|NCT02830997|"     In total knee replacement operations, the surgeon uses techniques and instruments to guide     the operation and ensure that all parts of the prosthesis (the artificial knee surfaces) are     placed into the correct position. There are many techniques a surgeon can use to achieve     accuracy in the operation. This study will compare the Principal Investigator's present     precision-guided technique and instrumentation methods with a newly developed technique that     uses a computer-based stereotactic guidance system. The purposes of the study are: 1.) to     learn whether the use of the different guidance systems results in differences of accuracy of     the placement of the prosthesis; 2.) to compare the length of time it takes an experienced     joint replacement specialist to complete the operation using the different guidance systems;     3.) to learn whether there are advantages of either system in terms of the function and     recovery of patients over the first year after surgery; and, 4.) to provide the manufacturer     of the stereotactic guidance system with feedback on the technical ease of use and workflow     ease of the system which may be used for training and education purposes and/or for planning     further refinements to the system. The study will enroll up to 150 patients from Athens     Orthopedic Clinic over 2 to 3 years.   "
34753|NCT02830880|"     The purpose of this study is to assess if using     anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will     be useful in determining if participants are responding to chemotherapy treatment.      Investigators will enroll participants whose cancer has been treated with hormone therapy and     now the cancer is not responding to the treatment (Castration -resistant), and so therefore     will be started on chemotherapy. Investigators will enroll thirty (30) participants in this     study.   "
34745|NCT02830984|"     Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important     techniques in the treatment of bile duct stones. A number of studies have been conducted     using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In     those studies, the authors suggested that EST plus LBD might lower the risk of post procedure     pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than the     pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary drainage     catheter can prevent PEP. However, it is still unclear that nasobiliary drainage after     endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative     pancreatitis in treating of large bile duct stones.The investigators therefore designed a     prospective randomized trial to determine whether nasobiliary drainage prevent PEP after     endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.   "
34746|NCT02830971|"     The nurses were learned the theoretical and practical skills previously during their     studentship period. The procedures will be the first time the nurses wanted to perform in     ICU. All clinical situations including patient, procedure, and shift will be similar for     nurses. The end point will be reaching to the 95 score of learning curve. The reason for     selection less than 5 percent variation was the flattening of learning curve (the plateau     section).   "
34747|NCT02830958|"     The hip is a commonly performed operation. It is a prosthetic joint replacement surgery whose     effectiveness depends on the quality of architectural and mechanical reconstruction of the     artificial hip, integrity and balance of the periarticular musculature. To achieve this dual     purpose, two elements are essential: access to the hip that best meets the musculature and is     able to restore the balance, and adequate prosthesis.      Despite the move towards a surgery less invasive hip replacement is a procedure that causes     tissue damage. This results in nociceptive and neuropathic pain, which can become chronic in     about 30% of cases.      Several studies have shown that there are risk factors for chronic post-surgical pain. They     are both related to patients but also to surgery.      Puolakka in his study correlates chronic pain and post-surgical acute pain following surgery     in surgical patients with total knee arthroplasty. Indeed, post-operative acute severe pain     multiplies by 10 the risk of developing chronic pain.      It is thus advantageous to reduce the postoperative pain, localized mainly in the     trochanteric region, to decrease the risk of developing chronic post surgical pain. Now     medical comunity know that the post-operative bruising and tissue damage are partly     responsible for these pains.      The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the     1970s It is water resistant and retains its properties up to 5 days.      It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure     on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive     stimuli.      Its designers also claim it would have a beneficial effect on the lymphatic and venous     circulation. According Kase Kinesiotaping causes an uprising of the epidermis decreasing the     pressure in the dermis and promoting lymphatic drainage through its mechanical action during     movement.      The lymphatic system is responsible for the capture of waste from venous blood (catabolites,     plasma proteins) and thus can promote the absorption of edema.      In his study, Donec highlights a significant decrease in pain and a higher absorption of     postoperative edema in the Kinésiotape® group than in the control group in surgical patients     with total knee arthroplasty .      The Curetape® band is used in the orthopedic surgery department since 2010 in current care.      Consequently, it seems interesting to evaluate the effect of Curetape® in surgical patients     with a total hip replacement.   "
34748|NCT02830945|"     American Indians (AI's) are experiencing an epidemic of stroke morbidity and mortality, with     higher prevalence and incidence, younger age at onset, and poorer survival than other racial     and ethnic groups. With a stroke incidence more than twice that of the general U.S.     population, stroke in AI's is a public health problem of staggering scope. AI's also have     disproportionate burdens of many risk factors for stroke, including hypertension, smoking,     obesity, and diabetes. However, no rigorous, population-based studies of stroke prevention     have included AI's. The investigators at WSU, and community partners, have designed the     Family Intervention in the Spirit of Motivational Interviewing (FITSMI), a program     delivered at the household level to encourage lifestyle changes that transform the home     environment and reduce stroke risk for all residents. FITSMI uses a talking circle format     in which facilitators guide participants to identify goals for change and create a tailored     plan for sustainable implementation that may target smoking, exercise, diet, or medication     adherence. FITSMI requires just 2 sessions (baseline and 1 month post-baseline), with text     messaging used to boost long-term adherence. In a group-randomized trial design, the     investigators will recruit 360 households where Strong Heart Family Study members aged 45 and     older reside. The investigators will assign half to FITSMI and half to a control condition     that receives educational brochures.   "
34749|NCT02830932|"     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the     Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F     Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to     Healthy Volunteers   "
34750|NCT02830919|"     This phase III clinical study will be conducted in Brazilian research sites. It will be     included in the study 314 participants diagnosed with primary knee OA according to the     classification criteria of the ACR. After a washout period, the participants will be     randomized to receive the combination of glucosamine sulfate + chondroitin sulfate of bovine     origin of Eurofarma Laboratorios S.A. (N= 157) or the combination of glucosamine sulfate +     chondroitin sulfate of Zodiac Pharmaceuticals S.A. Condroflex ® (N = 157). The treatment     period of the study will be of 24 weeks. Each participant will perform seven visits to the     research site. The main evaluations will be the improve of pain in the target knee by     questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and     quality of life by SF-12 questionnaire.   "
34751|NCT02830906|"     We would like to know the prophylactic anti-emetic effect of ramosetron compare to     ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and     intrathecal morphine .   "
34752|NCT02830893|"     This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever Actuated     Resonance Assistance. LARA facilitates patients in performing a high amount of practice using     their moderate to severely impaired upper extremity after stroke.      Investigators will recruit 44 subjects with subacute strokes to participate in the study     through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants     will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA     therapy group will use LARA to propel themselves to therapy appointments in the unit and to     play video games with the affected upper extremity for 30 mins / day. The standard therapy     group will use a standard wheelchair to propel themselves using their unaffected upper and     lower extremities. They will be asked to perform a matched duration of standard arm exercises     for 30 mins/ day. This program of standard arm exercises was developed by an OT at the     Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported     exercises.      This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge     from the acute rehabilitation unit if sooner, and a 3-month follow up.   "
34755|NCT02830854|"     A variety of non-pharmacological interventions have been used in the management of     Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic     modality has demonstrated conclusive positive results in terms of effectiveness. Although it     is still unknown what triggers AD, recent studies have shown that AD is associated with brain     energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental     molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable     mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and     perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis     to be evaluated in this project is that administration of H2 will positively affect     patient-reported outcomes and clinical biomarkers in men and women suffering from AD.   "
34756|NCT02830841|"     Remote ischemic preconditioning(RIPC) is emerging as an promising therapeutic paradigm to     combat the detrimental impact of ischemic and reperfusion injury. In liver transplantation,     ischemic and reperfusion injury severely impacts the post-surgery liver function and patient     outcome. This prospective, double blind, randomized clinical trial is aimed to test the     protective effect of RIPC against hepatic ischemic and reperfusion injury in pediatric liver     transplantation.   "
34757|NCT02830828|"     INTRODUCTION Carpal tunnel syndrome (CTS) is a common condition that results in impaired hand     function. In cases of CTS the pinch grip force between the thumb and index finger becomes     unnecessarily high to prevent objects from slipping when they are picked up.      HYPOTHESES The proposed study will investigate the following hypotheses regarding CTS.      As an object is picked up, the investigators suspect there will be several points at which     grip force will be different between patients with different severities of CTS, i.e. grip may     deteriorate as CTS gets worse.      The investigators also suspect grip force will be affected depending on the weight of the     object, i.e. patients with CTS may struggle with objects of a certain weight.      Patients with CTS sweat less, and this may affect their grip. The investigators suspect that     pinch grip in CTS patients is disproportionately altered by the frictional properties of the     object and by the moistness of the skin.      The investigators suspect patients with CTS will be less able to adapt to sudden changes in     an object's weight.      The investigators wish to examine how the above are affected after surgical treatment of CTS.      METHODS The investigators will include patients with symptomatic, idiopathic CTS, aged     between 18 and 80 years. The investigators' centre will recruit CTS patients who will attend     their National Health Service (NHS) outpatient appointment followed by nerve conduction     studies. An equal number of healthy participants will be recruited for comparison purposes.      At the aforementioned appointment, patients will undertake a pinch grip force test using a     device that will test the above points.      Patients will have normal care under their surgeon, which may include an operation for     treatment of CTS. Therefore some patients will be invited back to have grip tests again after     their operation. No aspect of the study will prevent a patient from receiving their normal     National Health Service (NHS) care.   "
34758|NCT02830815|"     This will be a prospective, blinded, cross-over study to compare the effects of two     anesthetic techniques on the interpretability of auditory brainstem response testing in     children.   "
34759|NCT02830802|"     The investigators aim to evaluate a sage-based mouthrinse (Dr. Hauschka Med, Mundspülung     Salbei) whether it is less or equal effective in alleviating inflammatory signs of intra-oral     mucosa and gingiva than an water/alcohol-based taste adjusted placebo in patients dependent     on ADL.      Randomization in treatment A (mouthwash with active agent, n=24) or treatment B (placebo     mouthwash, n=24) Supervised use of mouthwash A or mouthwash B over 6 weeks 1x/day additional     to habitual oral hygiene protocol.      The main outcome parameter will be Sulcus Bleeding Index SBI.   "
34760|NCT02830789|"     This study investigates whether calcium citrate or calcium carbonate are the optimal     supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass     operation.      Half of the participants will be randomized to receive calcium citrate, while the other half     will receive calcium carbonate. The study will be double blinded.   "
34761|NCT02830776|"     Topical bimatoprost has been shown to cause periorbital changes of soft tissue which are most     pronounced when used directly onto the cornea for the treatment of glaucoma. Changes are     primarily felt to be the result of prostaglandin-mediated adipocyte loss, resulting in     deepening of the upper eyelid sulcus and recession of infraorbital pseudoherniation. Use of     topical bimatoprost to the upper eyelid margin, now FDA approved for eyelash enhancement, may     provide a metered effect on the periocular tissues and allow for a topical approach to     periocular rejuvenation.      This is a proof of concept study which aims to enroll a series of patients with mild to     severe dermatochalasis, treat with topical bimatoprost 0.03% solution to the upper lid     margin, and evaluate for cosmetic improvement of the periocular area.   "
34762|NCT02830763|"     This study is planning to evaluate the safety and clinical efficacy of medium-chain fatty     acid capsules (food-grade CNT-02) in subjects with primary triglyceride deposit     cardiomyovasculopathy (TGCV) and neutral lipid storage disease with myopathy (NLSD-M)     associated with adipose triglyceride lipase (ATGL) genetic defects.   "
34763|NCT02830750|"     Prospective data collection of patients undergoing Atrial Fibrillation Ablation.   "
34764|NCT02830737|"     Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma     (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an     electrode needle directly into the tumor. This clearly violates no-touch technique based on     the principle of surgical oncology. Thus the 1-year recurrence rate of the cancer is up to     30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. No-touch     RFA treatment avoids the direct contact with the tumor that can cause the spread of cancer     cells in the liver, or the Antrim spread, Therefore it has been suggested that no-touch RFA     treatment reduce the recurrence rate after operation in comparison with the traditional RFA     treatment. This research project aims at using the prospective randomized comparative method     to compare the short-term and the long-term curative effects between no-touch RFA and     traditional RFA treatments for small hepatic carcinoma.   "
34792|NCT02830347|"     The aim of this study is to evaluate the nature of the change in oral and gut bacterial     resistance profiles after antibiotic therapy for a surgical procedure in two groups. The     intervention group will receive a course of amoxicillin and analgesics after surgical     extraction and have bacterial samples taken from saliva, tongue coatings and stool samples at     four appointments over a period of six months. This will be compared to the control group     which receive only analgesics after the surgical extraction.      An examination of the development and sustainability of antibiotic resistance in the oral and     gut microbiome of healthy cohorts will be followed up for 6 months, after surgical extraction     of impacted teeth.      Change in proportion of antibiotic resistant bacterial components will be studied using     Metagenomic DNA sequencing and quantification of resistant genes .   "
46099|NCT02682225|"     The primary objective of this study is to evaluate the abuse potential of intranasal     esketamine (112 milligram and 84 mg) compared to racemic intravenous ketamine (0.5 mg/kg) in     nondependent, recreational polydrug users of perception-altering drugs.   "
34765|NCT02830724|"     Background:      In a new cancer therapy, researchers take a person s blood, select a certain white blood cell     to grow in the lab, and then change the genes of these cells using a virus. The cells are     then given back to the person. This is called gene transfer. For this study, researchers will     modify the person s white blood cells with anti-CD70.      Objectives:      To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the     treatment is safe.      Eligibility:      Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer.      Design:      Participants will be screened with medical history, physical exam, scans, and other tests.     They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is     removed through a needle in the arm. A machine separates the white blood cells. The rest of     the blood is returned through a needle in the other arm.      Eligible participants will have an intravenous catheter placed in their upper chest. Over     several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in     the hospital.      Participants will take an antibiotic for 6 months after treatment. They will repeat     leukapheresis.      Participants will visit the clinic every 1-3 months for the first year after treatment, every     6 months for the second year, and then as determined by their physician. Follow-up visits     will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a     physical exam.      Throughout the study, blood will be taken and participants will have many tests to determine     the size and extent of their tumor and the treatment s impact.   "
34766|NCT02830711|"     The mood was influenced by many factors in children. Sport, such as high-altitude mountain     trek activity was thought benefit for human's mood and health. The expedition therapy was     more and more popular in many schools recently. However, as the investigators best knowledge,     there was no article discuss the relation between the mood and high-altitude mountain trek     activity such as benefit influence in children. So, the investigators conduct the study.      Method: Demographic data will be recorded. The Professor Yeh's mood questionnaires were used     to record the mood status of before and after the 3 days high-altitude mountain trek     activity.      Statistical analyses: Participants rated their emotional states (happiness, sadness,     anticipation, and anger) on a Likert scale. Each variable will be presented as descriptive     statistics. Student t test or other suitable statistical method(s) will be used to determine     the correction among the variables with scores of mood status. The paired t test or other     suitable statistical method(s) will be used to determine the correction among the scores of     mood status before and after the mountain activity. A difference was considered statistically     significant if the p value were less than 0.05. All statistical analyses will be performed     using SPPS statistical software for Windows, version 14 or more updated version.   "
34767|NCT02830698|"     The irritable bowel syndrome (IBS) is a very common disease in the pediatric population,     where classical medical treatment does not always prove effective. This clinical entity has     an impact on the individual physiological balance particularly on the autonomic regulation.     Studies concerning adults with irritable bowel syndrome, showed significant changes in heart     rate variability indices (HRV: heart rate variability).      The study of time and frequency domain analysis of HRV allows noninvasive and reproducible     assessment of the cardiac sympathetic and parasympathetic tone.      The investigators hypothesize that the sympathovagal balance could be altered in children in     case of prolonged nociceptive stress as the investigators find it in IBS. In recent years,     the control of pediatric pain experienced considerable growth through hypnosis techniques and     several studies have shown analgesic efficacy with a beneficial effect in terms of quality of     life in children.      Our study aims to assess the impact of the hypno-analgesia treatment of IBS on sympathovagal     balance. The investigators propose to realize in 7 to 18 years old children with IBS a single     center prospective study to highlight after a standardized hypnosis program, changes in the     time and frequency domain indices of heart rate variability and clinical or quality of life     parameters. The primary endpoint will be the high frequency HF indice. Secondary endpoints     will be the other indices of HRV (Ptot, VLF, LF, ratio LF / HF, SDNN, SDANN, pNN50, RMSSD),     the Quality of Life Questionnaire values (PedsQL ™ 4.0) a pain scale and the composite score     of Francis.   "
34768|NCT02830685|"     The rationale for present trial conception and design moves forward from the assumption that     a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is     feasible, safe and giving rewarding results when compared to the standard retro-pectoral     technique. Ahead of that, the trial aims to test if there is a difference in the outcomes     between a biological and a synthetic material when placed as a support under the mastectomy     skin flaps, both in terms of immediate complications and of long-term results.   "
34769|NCT02830672|"     In this randomized, prospective clinical trial, patients with trigger finger or trigger     thumb, will be treated with two different methods; ultrasound-guided release of the first     annular pulley or open surgical release of A1 pulley. Results will be compared regarding     functional, clinical and cosmetic outcome.   "
34770|NCT02830659|"     The purpose of this study is to determine the outcome of cochlear implant including post     operative hearing ability, developing of language, complication from cochlear implant,     quality of life, and success factor of cochlear implant.   "
34771|NCT02830646|"     Obesity promotes chronic kidney disease and is accelerating its shift to the stage of renal     replacement. Bariatric surgery is a treatment for severe or morbid obesity whose renal     benefit is currently unknown. The glomerular filtration rate (GFR) is the best parameter to     define the kidney function. It can be estimated using formulas by assaying endogenous markers     (creatinine, cystatin C) or measured with an exogenous tracer glomerular filtration (51     Cr-EDTA).      Bariatric surgery alters the production of endogenous markers and the extracellular volume     (VEC) with 2 important consequences on the assessment of GFR: the formula to estimate GFR is     not possible to compare renal function before and after surgery because of the variation in     production of endogenous glomerular filtration markers in the same subject; decreasing VEC     predicted decreased GFR after surgery, since these parameters are in part proportional to     each other.      Our working hypothesis is that bariatric surgery protects the kidneys of patients with     chronic kidney disease. To demonstrate this, investigators propose to compare the ratio DFG /     VEC before and after gastric bypass.      Goals The main objective is to measure the effect of gastric bypass on the report DFG / VEC.     Secondary objectives are to assess the effect of gastric bypass on the albumin / urine     creatinine and evaluate the performance of the main GFR estimating formulas in people with     severe or morbid obesity.   "
34773|NCT02830620|"     The syndrome of anorexia-cachexie, which accompanies numerous cancers is a major comorbidity     which compromises the forecast of these patients. Several cytokines pro-inflammatory as     interleukines IL1 ß, IL6 or TNFa participate in the physiopathology of this syndrome at the     man and the animal. Besides, it is now established that different neuronal populations,     localized in the hypothalamus, are nerve centers of the control of the appetite and the     energy homéostasie. However, there is not enough evidence of a direct action of cytokines on     these neurones, suggesting the participation of intermediate molecules as chimiokines,     inflammatory molecules produced in reaction to an immunological stress by gliales cells and     acting directly on the surrounding neurones. The implication of chimiokines in the syndrome     of anorexia-cachexie associated with the cancer thus seems very likely Among these,     chimiokines  Monocyte Chemoattractant Proteins 1-3  or MCPs represent obvious candidates     because they are produced by multiple tumors. Furthermore, to the mouse, the intellectual     expression of MCP1 is correlated in the anorexia led by peripheral injections of a bacterial     by-product, the lipopolysaccharide (LPS).      The investigators' main objective is to test at the Man's, in situation of cancer of the     pancreas any confused stages, the degree of prédictivité of the chimiokine MCP1 towards the     syndrome of anorexia-cachexie associated with the cancer. The investigator also suggest     describing: i) the link between rate plasmatique of MCP1 and energy metabolism on one hand,     physical composition on the other hand;; ii) the impact of the other chimiokines,     particularly those of the family of the MCPs, on the anorexia-cachexie bound to the cancer,     iii) the correlation enters their profile of expression plasmatique and the severity of the     anorexia, the energy metabolism and the physical composition; iv) the same research on the     other inflammatory factors plasmatiques, of nature different from chimiokines; v) the     correlation between thin mass and anorexia; vi) the evolution of the chimiokines various and     inflammatory factors after surgical treatment or chemotherapy with curative aim in 6 months.   "
34774|NCT02830607|"     Low back pain (Lower Back Pain ) is extremely common , affecting more than 80 % of the     general population in the modern world , one is considered the most common cause of     disability in people under the age of 45. Lower back pain represents a social problem and     substantial economies in Western countries , also considered a first cause for orthopedic     consultation. In recent decades , a number of methods developed for assessing the functional     status of patients with low back pain , and over twenty -five generic methods available today     for use in pain clinics , orthopedic clinics and in clinical trials A large part of the     measures used to monitor the response of patients to treatment of low back pain based on     self-report questionnaires ,on patients' pain intensity , quality of life measures , and     functional status In recent years a number of wearable monitoring devices designed to help     people assess the progress of sports activity , by measuring steps , pulse , and quality of     sleep , in this study we will use these measures to assess treatment efficacy after steroid     injection to the epidural space in patients with low back pain . And compare the results to     those taken from subjective self-report questionnaires .   "
34775|NCT02830594|"     This phase II trial studies how well pembrolizumab and palliative radiation therapy works in     treating patients with esophagus, stomach, or gastroesophageal junction cancer that has     spread to other parts of the body. Monoclonal antibodies, such as pembrolizumab, may     interfere with the ability of tumor cells to grow and spread. Palliative radiation therapy,     such as external beam radiation therapy, uses high energy beams to treat symptoms that are     caused by tumors. Giving pembrolizumab together with palliative radiation therapy may work     better in treating patients with esophagus, stomach, or gastroesophageal junction cancer that     has spread to other parts of the body.   "
34776|NCT02830568|"     The main objective of this multicentre study is to conduct the evaluation of cost-efficiency     of various techniques of kidney taking with regard the quality of life of the kidney living     donors.      It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery     pure or  hand-assisted  and cœliosurgery assisted by robot) and to determine their     respective advantages in quality of life, then their medico-economic consequences in a     cost-efficiency approach from the point of view of the society.      The evaluation will concern the donor and the receiver followed three months after the     taking.      The open donor nephrectomy will be the technique of reference with which will be compared the     two others.   "
34777|NCT02830542|"     The study will involve administering a single dose of investigational drug or placebo in     ascending dose cohorts. This study is designed to evaluate the safety and tolerability of     investigational drug as well as the efficacy of investigational drug versus placebo in adults     with primary (first episode) Clostridium difficile infection (CDI).   "
34778|NCT02830529|"     African Americans with prehypertension have a 35% greater risk of progressing to hypertension     than whites. Dietary Approaches to Stop Hypertension (DASH) is a gold standard intervention     for hypertension self-management. However, the barriers to self-management of hypertension     reported by AAs include stress, including perceived stress related to racism/discrimination;     perceived lack of control over getting hypertension in the future; limited social support;     and low motivation to change behaviors. Activating the emotional and task areas of the brain     are hypothesized to improve self-management behaviors. The purpose of this study is to test     the effects of a promising new self-management intervention for AAs, a Mindfulness Attitude     to Deliver the Dietary Approach to Stop Hypertension (MAD DASH) that departs from     conventional interventions to address prehypertension by combining two self-management     interventions (Mindfulness and DASH) in a group setting. Teaching mindfulness; a form of     meditation and the DASH diet to participants is expected to result in a reduction in blood     pressure as compared to usual care or DASH diet education alone.   "
34779|NCT02830516|"     Classically lung elastance and transpulmonary pressure are measured from the difference in     tidal variations of airway pressure subtracted by tidal variations i esophagus pressure     divided by the tidal volume. This requires the presence of a esophageal balloon catheter     which is cumbersome and costly. In this study values obtained as described above are compared     to values obtained with a new method in which a stepwise increase in positive endexpiratory     pressure (PEEP) is performed with a size which corresponds to the tidal volume which the     patient is ventilated with. These measurements are performed in anesthetized patients prior     to major surgery.   "
34793|NCT02830334|"     Background:      Doctors and nurses who work in non-mental health settings need ways to know when patients are     at risk. Researchers created the Ask Suicide-Screening Questions (ASQ) to be used in an     emergency department for children. This is a 4-item suicide risk screening tool. We wanted to     see if this is also a good tool to use in the outpatient setting. Two studies are being done     to test it at hospitals. This study is for researchers to analyze the data from those two     studies.      Objectives:      To combine and analyze data from two studies to see how well the ASQ can detect suicide risk     in pediatric outpatient clinics.      Eligibility:      No people are enrolled in this study.      Design:      Participants in the two non-NIH studies will give consent for their data to be shared.      The data will be confidential and secure. They will have no personal information attached to     them.      Researchers will get the data and analyze them.   "
34780|NCT02830503|"     Project summary      Rationale      Many NICU's replace their feeding tubes once a week or more rarely in order to avoid     disturbing the infants. The researchers discovered that there are high concentrations of     potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even     within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the     colonization of the gut, and development of dysbiosis might lead to necrotizing     enterocolitis. The researchers speculate if replacing the resident feeding tube every day and     thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the     feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal     tract of the infant and hence a reduced competition with probiotic colonization.      Objectives      The investigators plan to conduct an intervention study in premature infants receiving     probiotics (< 32 weeks of gestation) where the feeding tube will be replaced every day in the     intervention group and once a week (standard practice) in the control group. The main outcome     will be bacterial concentration in the stomach after one week of life.      Methods      The study is a prospective, randomized controlled trial in preterm infants. Infants will be     randomized to the intervention group in which the tube is replaced every day or the control     group which will follow normal practice in the department. The intervention will last one     week. The infants will be followed until discharge. The investigators plan to include 11     infants in each group.      Primary outcome      Concentration of bacteria in gastric aspirates on day seven.   "
34781|NCT02830490|"     The investigators pretend to calculate values absolute and relative reliability that have not     been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).   "
34782|NCT02830477|"     The primary objective of this study is to investigate weekly prophylaxis dosing regimens used     in standard clinical practice.      In addition the study will capture reported bleed rate, pattern of change in KOVALTRY     prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product     switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data     (if performed), KOVALTRY consumption, as well as safety data.   "
34783|NCT02830464|"     In this study, prognostically relevant biomarkers for cardiovascular / renal insufficiencies     will be clinically evaluated, to improve the course of assessment of such disease and to gain     new insights into the typical course of congestive heart failure. This is a prerequisite to     allow patients to appropriate treatment as soon as possible.   "
34784|NCT02830451|"     Clinical, diagnostic, and therapeutic data as well as information on adverse events and HRQOL     outcomes specific for patients with metastatic spine tumor(s).   "
34785|NCT02830438|"     In this proposal, the aim is to examine shear wave elastography (SWE) measurements in     diseased native kidneys and correlate them with grades of fibrosis using histological     samples.      The overall goals of the proposed study are addressed by the following specific aim.      Specific aim: To determine whether differences exist in elasticity measurements between     native kidneys with and without fibrosis.      Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue     elasticity and stiffness compared to kidneys with zero fibrosis.   "
34786|NCT02830425|"     A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.      Objectives:        1. To estimate and describe patterns of multimorbidity and polypharmacy in patients over 64          admitted for a chronic disease exacerbation.        2. To analyze the potentially inappropriate prescribing (PPI) drugs according to STOPP /          START (SS) criteria.        3. To evaluate the relationship between multimorbidity and PPI and adverse medication (RAM)          preventable reaction.      The cohort will include 800 patients >64 years admitted in internal medicine and / or     geriatric department of 5 hospitals of the National Health Service. Application of the SS     criteria (released in 2015) on admission and at discharge, and collection of demographic and     clinical variables including comorbidities, baseline chronic medication, geriatric syndromes,     functional capacity and RAM. Descriptive analysis and bivariate parametric or nonparametric     tests will be applied to analyze relationship between morbidity, polypharmacy, SS criteria     and RAM. Intraobserver agreement will be assessed for SS criteria. Multiple regression     techniques will be applied, where the dependent variable will be the PPI or the RAM.   "
34787|NCT02830412|"     This project intends to develop and implement an electronic reminder for post-operative     nausea and vomiting (PONV) prophylaxis into the Anesthesia Record Keeping System.      Each patient will have his or her PONV risk classified based on the following risk factors:     Female gender, History of PONV, History of Motion Sickness, Non-smoker and Duration of     procedure > 60 minutes.      Patients will be randomized to either receive the PONV reminder or not. Those receiving the     PONV reminder will have the PONV risk assessment and current guideline information for PONV     prophylaxis displayed on the Anesthesia Record Keeping System (ARKS) screen at the beginning     of the case.      At the end of the procedure (specific at documentation of emergence), the reminder will     assess the current status of PONV prophylaxis as per anti-emetic medications administered and     compare the current status to the recommended status based on published guidelines.      If the current status is compatible or exceeds the recommended status the reminder will     silently document compliance.      If published guidelines suggest additional PONV prophylaxis based on the patients risk     profile and a comparison with the currently documented status, an electronic reminder will     appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance     guideline adherence.      The reminder will not recommend a specific medication, intervention or therapy.      It will be completely the decision of the anesthesia provider if and how to modify the PONV     prophylaxis for the patient.      Subjects randomized to not receive the electronic display will have it deactivated.   "
34788|NCT02830399|"     It's a prospective, multicentric, randomized, controlled study concerning 84 patients with     treatment-resistant depression (TRD). The aim of the study is to evaluate the augmentation of     Electroconvulsive therapy (ECT) by repeated Transcranial Magnetic Stimulation (rTMS). The     primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating     Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the     safety and most particularly the cognitive effects of this association.   "
34789|NCT02830386|"     This study aims to investigating the efficacy and safety of low profile visualized     intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular     aneurysms. The follow-up duration is 1 year.   "
34795|NCT02830308|"     Background:      There are many endocrine and metabolic-related conditions. Two well-known disorders include     diabetes and thyroid disease. Some of these diseases are caused by a change in genes.     Researchers want to identify the genes involved in these disorders. They hope this will help     them learn more about these diseases.      Objectives:      To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in     adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.      Eligibility:      Adults age 18 years and older with a known or suspected endocrine disorder.      Relatives ages 18 years and older.      Doctors will review all requests and available medical records to determine final eligibility     for the protocol.      Design:      Participants will have a medical history and physical exam.      Most participants will have 1 visit, and may have follow up visits if necessary. They may     have tests, surgery, or other procedures to help diagnose or treat their condition. These     could include:        -  Blood, urine, and saliva tests        -  Imaging tests. These may include X-ray, ultrasound, or scans.        -  Sleep study        -  Medical photographs        -  Visits with other specialists at NIH      Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may     be stored in the freezer for future studies.      Participants may be asked to participate in genetic testing. They will give a blood or saliva     sample for this.   "
34796|NCT02830295|"     A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients     as compared with a control intervention consisting of treatment as an usual. Sessions of BBAT     lasted 90 minutes each and took place twice a week for 5 weeks. The primary end point is a     change in the Visual Analog Scale score and Body Awareness Rating Scale and the secondary end     points include Hospital Anxiety Depression, State Trait Anxiety Inventory, Beck Depression     Inventory and Short Form 36. All assessments will be repeated at post treatment, 12 weeks and     24 weeks   "
34797|NCT02830282|"     This is a nested multicenter, prospective cohort study within the I-SPY 2 TRIAL for women     undergoing neoadjuvant chemotherapy for primary breast cancer who are also undergoing     definitive surgical resection and have clinical or radiographic evidence of residual tumor at     the completion of chemotherapy.   "
34798|NCT02830269|"     Transcranial Doppler ultrasonography is usually used in the evaluation and management of     patients with cerebrovascular disease. This noninvasive method measures local blood flow     velocity and direction in the proximal portions of large intracranial arteries. The operator     requires a short training and experience to perform. The third ventricle diameter measurement     by transcranial duplex flow sonography was performed in healthy volunteers . This studies     show similar results in those obtained with the MRI or Computer Tomography (CT). Currently     the third ventricle diameter measurements by transcranial Doppler ultrasonography was not     validated for neuro-intensive care unit patients. The investigators propose to used recent     ultrasound system to validate the third ventricle diameter measurements in comparison with     the standard method (CT).   "
34799|NCT02830256|"     Nociception in intensive care unit is frequently evaluated with some tools such as BPS     (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in     intubated and brain injured ICU patients. The investigators propose to validate the NCS     adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the     Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).   "
34800|NCT02830243|"     The purpose of this clinical trial is to compare analgesic effect of sevoflurane and     desflurane at equal minimum alveolar concentrations using surgical pleth index.   "
34801|NCT02830230|"     There is a strong causal association between persisting genital tract infection with Human     Papilloma Virus (HPV) and gradual progression of infection to cervical (mouth of uterus)     cancer.The robust study from India have shown that single round of HPV DNA screening test to     significantly reduce the cervical cancer mortality. The above findings are very encouraging     since it demonstrates that a simple and reliable HPV DNA test which is now available in low     income countries has a potential to be accepted as primary screening test in future.      The cross-sectional studies from developed countries from year 1999-2004 which focused to     determine the test characteristics of HPV Hybrid Capture 2 test (HC2) to determine CIN2 and     higher grade lesions, reported test sensitivity of 90% to 100% with a mean of 95%.      Similarly the cross-sectional studies from developing countries from 1993 to 2003 which have     focused on test characteristics of HPV DNA Hybrid capture 2 (HC2) test to determine CIN2 and     higher grade lesions has shown a sensitivity in the range of 50% to 91% with an average     sensitivity of 79%.Among the developing countries cross-sectional study from India which     evaluated test reported sensitivity of only 68.2%.      There is a statistical significant difference ( p value = 0.003) of sensitivity of HPV DNA     HC2 test between the developed and developing countries to determine CIN2+ Lesions while     there is no difference in the specificity.      A study that was conducted in Chinese women to detected the prevalence of HPV genotype among     women with mucopurulent cervicitis, healthy women and women with Invasive cancer, the author     reported a 10% higher failure rates to extract HPV DNA in cases of mucopurulent cervicitis as     compared to other two groups.      So the study will explore if if the presence of untreated co-infections with STIs/RTIs     (Sexually transmitted infections/Reproductive tract infections) resulting in cervical     inflammation is somewhere interfering with low sensitivity of HC2 test due to presence of     blood and excess mucus associated with the conditions leading to low sensitivity of the test     in context to Indian Scenario.   "
34802|NCT02830217|"     ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden     myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary     intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients     are readmitted shortly after the primary PCI for several unfavorable clinical outcomes     including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart     failure. This study is intended to test the predictive ability of a new biomarker soluble ST2     (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly     associated with unfavorable clinical outcomes of patients with ischemia heart diseases and     heart failure. This study will further investigate the ability of sST2 to predict unfavorable     outcomes for STEMI patients after primary PCI.   "
34803|NCT02830204|"     The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3     valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis     (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed     inoperable due to the extent of calcification.   "
34827|NCT02829892|"     Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the     relationship with the environment and empower people. Patients with AD present in 90% of     cases of behavioral disorders and of these behavioral disorders include agitation, apathy but     also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on     the behavior of patients with AD. The main objective of the study was to assess the influence     of environmental light nighttime sleep of residents.   "
34804|NCT02830191|"     Ciclosporin A (CsA) is an immunosuppressive drug used in organs and tissues transplantations     (kidney, heart, liver, bone marrow ...) to prevent rejection, and in different autoimmune or     inflammatory diseases. A therapeutic drug monitoring (TDM) is required during a CsA     treatment. It is justified by a narrow therapeutic range between efficiency and     nephrotoxicity, and by large intra- and interindividual pharmacokinetic variability. TDM of     CsA is conventionally performed by determining residual concentration, and sometimes     concentration at 2 hours after administration. TDM of CsA is currently performed by venous     sampling on ethylenediaminetetraacetic acid (EDTA). Dried blood spot (DBS) sampling could be     a particularly interesting alternative to conventional blood sampling. With DBS, capillary     blood is obtained from a finger prick by the patient himself, and the blood drop obtained is     deposited on filter paper, which can be stored at room temperature and then be sent to the     laboratory by mail.      This sampling method has several advantages : it requires small blood volumes, it is less     invasive than conventional venous sampling, sampling can be performed by the patient himself     at home few days before the consultation, and the results of the analysis can be available to     the clinician on the day of consultation, allowing dose adjustment more quickly.      Several studies have been published in recent years using DBS sampling method, for various     drugs such as antimalarials, antiepileptics, antiretrovirals, metformin, benzodiazepines, or     immunosuppressants. Only one clinical validation study of TDM of CsA using DBS method was     published by Wilhelm et al. (2013) in a population of 38 patients who received allogeneic     stem cell transplant recipients. The results showed excellent correlation between the     concentrations determined by the two sampling methods.      The investigators propose an observational study at the University Hospital of Caen for     clinical validation of DBS sampling for TDM of CsA in kidney transplantation, for which there     are no data published. During a nephrology consultation, for each patient, venous and finger     prick blood samples are simultaneously collected. CsA assays were performed by liquid     chromatography-tandem mass spectrometry (LC-MS/MS) for the two sampling methods. A specific     LC-MS/MS assay method applied for DBS samples was developed and validated for this study     (DBS/LC-MS/MS). Correlation between the results obtained from the two sampling methods will     be evaluated, on at least 100 samples. Patients have to answer a questionnaire to assess pain     and comfort of DBS sampling, and feasibility of self-sampling at home by this method. The aim     of this clinical validation study of DBS sampling is the establishment of the systematic TDM     of CsA for renal transplant patients by DBS sampling at the University Hospital of Caen.   "
34805|NCT02830178|"     The Purpose of this study is to examine whether evidence of channeling exists by analyzing     within a cohort of participants with first prescriptions of single-ingredient paracetamol or     ibuprofen (or both) whether participants with paracetamol were more likely to have an     ibuprofen-related contraindication.   "
34806|NCT02830165|"     This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients     with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery.     SBRT is a type of external radiation therapy that uses special equipment to position a     patient and precisely deliver radiation to tumors in the body. Delivering radiotherapy before     prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than     delivering radiotherapy after prostatectomy.   "
34807|NCT02830152|"     Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses     a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a     non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of     LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the     effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in     patients with NVAF and prior ICH.   "
34808|NCT02830139|"     The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal     metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial     is that radical colorectal resection plus HIPEC is superior to only radical colorectal     resection in terms of overall survival.   "
34809|NCT02830126|"     The purpose of this study is to implement an Anesthesiology Control Tower (ACT). This pilot     study will employ the existing information technology infrastructure at Barnes Jewish     Hospital to create a remote monitoring and alerting system for the operating rooms. Similar     to telemedicine methods employed in critical care, the ACT will support operating room     clinicians in adhering to best-practice principles.   "
34810|NCT02830113|"     This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of     chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive     protein(CRP) level amongst non-diabetic subjects.   "
34811|NCT02830100|"     The goal is to define what is the nature of intern speech, how it manifests itself, who deal     with agency in intern speech and finally what is the role of intern speech in attention     tasks.   "
34812|NCT02830087|"     This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol     by gaining a better understanding of the relationship between tourniquet pressure and time,     and intraoperative performance and post-operative outcomes. This study does not seek to     answer the question of tourniquet vs no tourniquet, but to seek a tourniquet usage that     would maximize the intraoperative benefits for the surgeon and minimize the negative     consequences for patient outcomes.      Specific Aim #1: enroll around 146 primary TKA patients.      Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in     relation to intraoperative performance.      Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative     pain and complications of short-term, intermediate, and long-term followup.      Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative     function of short-term, intermediate, and long-term followup.   "
34813|NCT02830074|"     Sleep-disordered breathing (SDB) remains under-treated in individuals living with spinal cord     injuries and disorders (SCI/D). The investigators' aim is to test a program that addresses     challenges and barriers to positive airway pressure (PAP) treatment of SDB among patients     with SCI/D. The investigators anticipate that patients who receive this program will have     higher rates of PAP use and will demonstrate improvements in sleep quality, general     functioning, respiratory functioning and quality of life from baseline to 6 months follow up     compared to individuals who receive a control program. This work addresses critical     healthcare needs for patients with SCI/D and may lead to improved health and quality of life     for these patients.   "
34814|NCT02830061|"     This study looks at the experiences of teenagers and young adults who have been offered     ovarian tissue cryopreservation prior to cancer treatment as a result of their cancer and/or     cancer treatment putting them at moderate-to-high risk of premature ovarian failure.   "
34854|NCT02829541|"     The primary objective of the study is to evaluate the safety and tolerability of single oral     doses of BIIB068 in healthy participants. Secondary objectives are to characterize the     single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the     effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine     the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the     single-dose PK of BIIB068 in healthy participants.   "
34815|NCT02830048|"     Diabetes is a chronic condition that affects 1 in 16 people in the UK, and leads to     difficulty controlling blood sugar levels. This is due to an imbalance between two main     hormones: insulin, which lowers blood sugar, and glucagon, which causes it to rise. Most     current anti-diabetic medications work to improve insulin levels, however research is now     shifting to better understand how glucagon levels play a key role in this disease.      Glibenclamide is a type of anti-diabetic medication (sulfonylurea) which is commonly used to     increase the amount of insulin released by the pancreatic beta-cells. Studies in mice and     human cells from donors with type 2 diabetes have shown that sulfonylureas can also improve     glucagon levels when used in very small doses by working on different cells in the pancreas     (alpha-cells).      The aim of this study is to find out whether low doses of glibenclamide can improve glucagon     levels in patients with type 2 diabetes, and whether in the future this could be used to     better control high blood sugar levels, without the risk of causing low blood sugar.      Participants with type 2 diabetes who are diet-controlled or on metformin will be given a     liquid containing a low dose of glibenclamide. They will need to attend the OCDEM Clinical     Research Unit at the Churchill Hospital, Oxford, for early morning blood tests every 3-4 days     over a period of 3 weeks. A continuous glucose monitor will also be fitted during this time.      This study is funded by the NIHR OxBRC.   "
34816|NCT02830035|"     The purpose of this study is to compare the clinical efficacy of real-time ultrasound     guidance on spinal anesthesia vs the traditional anatomical landmark technique, by comparing     success rate of spinal needle insertion, success rate rate of single needle pass, duration     and immediate complications.   "
34817|NCT02830022|"     Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and     behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to     ASD. The investigators proposed to explore the impact of physical activity on these     disorders. In this context, it is necessary to characterize the cardiorespiratory capacities     of ASD children in order to promote physical activity for this population. To examine     potential differences between ASD and control children, some explorations were proposed: a     maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of     autonomic nervous system).      An actimetry during one week (evaluation of physical activity and sleep) completed this study     in order to specify sleep characteristic and established the possible link between physical     activity sleep characteristics and physical fitness in ASD children.   "
34818|NCT02830009|"     The aim of this study is to know the difference between protein profiles (multi-analyte     profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings.     Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also leads to the     formation of kidney stones.      The aim is to identify patterns of discriminating markers associated with primary     hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.   "
34819|NCT02829996|"     Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of     topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in     subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.      All subjects who meet the study's enrollment criteria following Screening will undergo     washout of all prohibited medications (if washout is needed), including their routine     glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to     both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes     for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing     in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active     drug product. During the Treatment Period, study drug (Active and Placebo) eye drop     applications will occur twice daily, in the morning and in the evening. The Treatment Period     will be followed by an Observation Period of approximately 7 days wherein no study eye drops     are instilled.      The purpose of the study is to assess the overall benefit/risk profile of binocular topical     application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost     (0.005% or 0.0025%) one drop daily (QD) for 8 weeks.   "
34820|NCT02829983|"     To assess the periodontal clinical response and the possible adverse effects of the     clarithromycin combined to periodontal mechanical therapy in the treatment of patients with     generalized aggressive periodontitis.   "
34821|NCT02829970|"     There are currently no published randomized controlled studies examining psychosocial     interventions for college students with ADHD, and none specifically targeting AUDs in this     population at any age, despite the clear indication from emerging research of the need for     such interventions. In the current study, the investigators will develop BA-based treatment     intended to increase involvement in healthy, goal-directed activities (e.g., academic,     recreational or social activities) and to reduce problematic drinking behaviors and other     risk behaviors (e.g., unsafe sex) among college students with ADHD (Behavioral Activation for     Attention & Alcohol Disorders; BAAAD). Finalized treatment manuals, altered based on focus     group feedback, will be tested in a stage I randomized controlled trial (RCT) among 80     college students randomized to BMI + BAAAD or BMI + supportive counseling (SC). The     investigators expect that BMI + BAAAD will be successful with college students with ADHD, in     terms of decreasing the escalation of problematic alcohol use behaviors, as compared to BMI +     SC. This treatment development study will set the stage for larger-scale RCTs.   "
34822|NCT02829957|"     A large proportion of women with menstruating potential with newly diagnosed VTE or atrial     fibrillation, treated with apixaban will have less menstrual blood loss than patients     randomized to rivaroxaban.   "
34823|NCT02829944|"     The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine     (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer     similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will     reduce the pain experienced after cesarean section and need for narcotic pain medicine.   "
34824|NCT02829931|"     The main purpose of this study is to evaluate the safety and tolerability of nivolumab, given     in combination with hypofractionated stereotactic re-irradiation of recurrent high grade     gliomas.   "
34825|NCT02829918|"     This research study is designed to see if a drug called Nivolumab is effective in treating     patients with advanced refractory biliary tract cancers. Nivolumab has been approved by the     U.S. Food and Drug Administration (FDA) for treatment of certain types of cancer but is not     approved by the FDA for treatment of your type of cancer.   "
34828|NCT02829879|"     Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in     response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to     any dental condition or pathology. Multiple therapies for the treatment of DH have been     studied, including equivocal evidence about the efficacy of potassium nitrate salts and     recent investigations a promising new 8% Arginin dentifrice.      Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm     sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2)     dentifrices in the treatment of dentin hypersensitivity.      Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy     volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile,     with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar     teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8% arginine/1450     ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium nitrate/2500 ppm     sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene habits will be     recorded in a clinical chart, while O´Leary plaque index and dentin hypersensitivity (DH)     measurements will be clinically assessed, at baseline, 4 and 8 weeks. DH will be evaluated     through the mean VAS value in response to evaporative and thermal stimuli at baseline, 4 and     8 week follow-up. The data will be analysed through Stata® V11 program.   "
34829|NCT02829866|"     Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are     constantly looking to improve all aspects related to this procedure weather is improvement of     implant design, instrumentation or surgical technique. Excellent clinical and radiological     results were observed at medium and long term in the last years for AMIStem system.      This observational study has the objective to survey hip prosthesis stability and function of     the operated hip in patients who are not exposed to surgical risks. The principal     investigator will contact all patients in order to perform the follow-up visit according to     standard practice. Patients operated between January 2010 and December 2011 will be invited     in the study during the clinical visit organised according to standard practice. Preoperative     clinical and radiological data, intraoperative details and postoperative follow-up data at     1-year will be retrospectively collected. Five-year data will be prospectively collected     after inclusion in the study.   "
34830|NCT02829853|"     Major impacts of air pollution are lung diseases such as granulomatous diseases and mainly     sarcoidosis. Understanding the respective role of inorganic / nanoparticles and genetic     background in these chronic diseases is a major challenge for the management of patients and     prevention strategies. Granulomas are characterized by giant epithelioid and multinucleated     cells, reflecting a severe disturbance in immunological pathways induced both by toxic     exposure and genetic predisposition. Previous studies demonstrated that professional     environmental context and acute exposures (the World Trade Center disaster) to     micro/nanoparticles have a pathogenic impact with a sharp increase in sarcoidosis.     Sarcoidosis is a multifactorial disease occurring in a genetically vulnerable context. Many     gene variants have been linked to an increased odds-ratio of the disease, such BTNL2,     CCDC88B, ANNEXIN A11 involved in regulation of T-cell activation and maturation pathways. We     have contributed since 2008 to a national cohort (GSF, 28 centers) of ≈ 800 sarcoidosis     patients with familial and sporadic presentation of the disease. This collection has been an     exceptional (and worldwide unique) tool for the implementation of an exhaustive clinical     database on sarcoidosis, modelling of disease evolution and identification of clinical /     genetic criteria differentiating sporadic and familial forms.      The main goals of the project are:        1. Completion of the genetic data in order to establish a pattern of gene variants          segregating with familial forms of the disease, compared to sporadic one. This will be          done by WES (WHOLE EXOME) analysis on the previously collected DNA samples. The informed          consent for the patients included the information about the BTNL2 gene, which has been          already tested since 2008, and related genes connected to immune pathways, thus allowing          a unambiguous information about the research finality of the project.        2. Completion of the clinical data about each patient, in cooperation with the GSF network,          management of the database established since 2008. The data collected are those which          are commonly detailed in the normal follow-up of the patients. The project do not          include any new interventions on the patient (neither radiological or invasive tests).        3. Specific biological studies might be done on the white blood cells of the patients, and          might need in such cases a new blood sampling, both in patients and first degree related          healthy controls. Theses specific studies will be presented to an ethical committee          (CCP) in order to validate the feasibility in term of 'new intervention' on the cohort.          The samples collected will be at the same volume of a classical blood sampling (2*7 ml).        4. Any other projects, submitted to the GSF network will needed a specific registration and          ethical committee validation.   "
34831|NCT02829840|"     The goal of Part 1 of this clinical research study is to learn if ponatinib alone can help to     control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this drug will also be     studied.      The goal of Part 2 of this clinical research study is to find the highest tolerable dose of     ponatinib in combination with 5-azacytidine and to learn if the highest dose level found can     help to control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this     combination will also be studied.   "
34832|NCT02829827|"     The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and     the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant     infantile spasms   "
34833|NCT02829814|"     The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets,     taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.      The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for     fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide     strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain,     sleep and other FM symptomatology.   "
34834|NCT02829801|"     The animal-assisted therapy (AAT) is now considered a non-drug care and is often used in     geriatrics. Many studies have shown a link between the presence of the animal and the     psycho-behavioral symptoms decrease in dementia (PBSD) such as depression, anxiety or     irritability that affects their quality of life and improved cognitive abilities. However,     many methodological flaws in these researches exist.      The aim of the study is to evaluate the effectiveness of AAT on the well-being of patients     with Alzheimer disease (AD) at the stage of Major Neuro Cognitive Disorder (NCD) at short and     medium term (before care, during care (at the beginning and end of each session), 1 week     after, 2 weeks and 1 month after the last session) compared to a group receiving the same     stimulation without the dog's response.      Patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed: AAT     group versus control group. The only difference between these two groups is the intervention     of the dog at each workshop in the AAT group.      Each workshop will consist of three identical times. It will begin with a 15 minute     introductory activity, the first goal will be to establish a relationship with patients     (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical     in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of the     session This study should highlight a positive effect of animal assisted therapy on the     well-being, PBSD, depression, anxiety and cognitive abilities and a long-term retention of     these positive effects.   "
34835|NCT02829788|"     The peritoneum is the second most common site of recurrence in patients with colorectal     cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the     prognosis of these patients and incorporates surgical removal of all visible disease followed     by chemical destruction of microscopic disease through chemoperfusion. The most validated     predictors of outcome are preoperative tumor burden measured in terms of the peritoneal     carcinomatosis index (PCI) and completeness of cytoreduction (CC score). Diagnostic     laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal     cancer and has been shown to be effective in excluding unnecessary laparotomy associated with     higher morbidity.   "
34836|NCT02829775|"     This open label extension study will give an opportunity to the participants that have     responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant     Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal     Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for     Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant     Melanoma (MM).   "
34837|NCT02829762|"     The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of     geriatric and Social intervention associated techniques of Domotic and Remote assistance     (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of     isolation, treated for locally advanced or metastatic cancer.   "
34838|NCT02829749|"     The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair     technique as compared with conventional open-heart on-pump mitral valve surgery in patients     with severe primary mitral regurgitation.   "
34839|NCT02829736|"     Chest tubes are used routinely although preliminary studies demonstrate the feasibility and     safety of intraoperative chest drain removal. Previous studies are however either     retrospective or mainly concerning benign disease.      Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge     resection have less pain, better pulmonary function and similar complication profile than     participants treated with standard post-operative chest tube, and could possibly be     discharged earlier.   "
34840|NCT02829723|"     The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in     combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK),     pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent     or in combination with PDR001, administered intravenously (i.v.) in adult patients with     advanced solid tumors.      Dose escalation will be guided by a Bayesian logistic regression model with overdose control.     Once MTD/ RP2D is declared, patients will be enrolled in the phase II part in the selected     indications (glioblastoma, pancreatic cancer and triple negative breast cancer) to further     assess the preliminary anti-tumor activity of BLZ945 in combination with PDR001. Should signs     of anti-tumor activity be seen in the phase I dose escalation with BLZ945 as single agent, a     phase II part will be opened in order to further explore BLZ945 single agent efficacy at the     recommended dose.   "
34841|NCT02829710|"     Management of analgesia and sedation is an integral component of the medical care of a     critically-ill child. Its role is to assure comfort and safety to a patient undergoing     painful cares and technical procedures; it can also be, in particular situations like acute     respiratory distress syndrome or acute brain injury, a full processing treatment.      Sedation involves, most of the time, the association of an opioid and a sedative. The use of     these drugs is difficult in children, because of a specific metabolism, inducing tolerance     and withdrawal in case of prolonged administration.      The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible     score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to     avoid inadequate sedation.      Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation,     longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data     suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the     treatment to the patient's need and permit a reduction in the duration of mechanical     ventilation.      The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric     intensive care unit on duration of mechanical ventilation, total doses and duration of     medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of     ventilator-associated-pneumonia and occurrence of withdrawal.   "
34842|NCT02829697|"     The aim is to investigate the effect of perineural administration of a series of different     volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability     of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers.      The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but     only to a certain degree. After a sufficient volume a 'saturation level' will be reached, and     nerve block duration will not increase further.   "
34843|NCT02829684|"     Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth.     PWS represents a large fraction of mental retardation syndromes due to a genetic cause and     the most frequent cause of genetic obesity. The majority of the patients are seen by     paediatricians. This syndrome is responsible for severe physical, psychological and social     impairments.      The diversity and the severity of the manifestations of this disease explain the requirement     of multidisciplinary care which deserve specific evaluation. Today the follow-up and     management of a great proportion of these patients are greatly insufficient if not absent.      Teams strongly lack information on the natural history of this severe disease and on the     factors involved in its evolution and the outcome of these patients throughout life. The     present project is to implement a register in the whole country for children and adult     patients   "
34855|NCT02829528|"     An initial evaluation of Little Flower Yoga for Kids will be conducted in a small sample of     18-30 Kindergarten and First Grade students (3-5 per class) enrolled in Girls Preparatory     Charter School of the Bronx. The overall aim of this study is to ascertain the short and     longer-term effects of Little Flower Yoga for Kids, a promising yoga and mindfulness program     for children, which incorporates five elements (connect, breathe, move, focus, relax) to     improve the child's ability to sustain attention and regulate emotions.   "
35209|NCT02824926|"     This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate     efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control     (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment,     treatment and follow-up visits. Treatment period is 14 days.   "
34844|NCT02829671|"     Suicide is a major health problem that causes annually a million death worldwild. Loneliness     is known to be associated with suicidal ideation in minors and to be related with suicidal     risk in elerly people. However little is known about this association in a middle-aged     population. Loneliness is a modifiable factor with suitable psychotherapeutic measures, it is     essential to improve the scientific and medical knowledge about the link between this feeling     and suicide risk in a population of depressed patients in middle age.      The main objective is the study of the relationship between loneliness and the occurrence of     SB in major depressed adult population over 12 months.      The secondary objectives are:        -  Identification of risk factors (clinical, neuropsychological and biological) of the          occurrence of SB within a clinical population and their interaction;        -  Identification of predictive factors (clinical, neuropsychological, biological)          therapeutic response to antidepressant in the context of depression.   "
34845|NCT02829658|"     Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability     and impulsivity. Several North American prospective studies support the high level of mental     health care utilization in this population. There is little data in other systems of health     organization, such as France. Furthermore, little is known on the variables associated with     the mental health service utilization among BPD patients.      The main objective was to compare the utilization of mental health care among BPD patients,     to the general population and patients with another personality disorder (PD) and to describe     the demographic and clinical factors associated with the group of patients who use the most     health care.   "
34846|NCT02829645|"     Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects     in the quality of life of patients and thier relatives. Management of ED is very difficult :     the prognosis remains relatively poor both in terms of remission rate and quality of life. In     this context, the contribution of new strategies for pathophysiological exploration and the     development of therapeutic options are crucial.      In this project the investigators aim to constitute un cohort of patients from a day unit     specialized in the management of ED. A prospective follow-up will be offered to patients to     assess their clinical and psycho-social evolution. The overall objective is to identify which     factors are prognostic of clinical improvement of the ED. We also want to better characterize     patients that will migrate from diagnosis to another.   "
34847|NCT02829632|"     Brief Summary: This randomized clinical pilot will test the feasibility of having individuals     self-monitor for 12 weeks and based on what the participants record be given feedback     messages. The investigator will use this information to refine the questions and data     collection procedures for the larger study.      Participants will be randomized into 3 groups        -  self-monitoring only        -  self-monitoring w/ feedback messages        -  self-monitoring w/feedback messages and group sessions Feedback messages will be          delivered up to 4 times per day using a different schedule. The group sessions will be          held in the 2nd, 4th and 8th week of the 12-week study.      All participants will be asked to complete questionnaires and 2 assessment visits at baseline     and 12 weeks.   "
34848|NCT02829619|"     Meal times differ from culture to culture. These differences may influence energy regulation     and, consequently, body weight. Current studies support the notion that not only what but     also when the investigators eat may have a significant role in obesity treatment. Recently,     it has been shown that eating the main meal of the day, lunch in Spain, late in the day is     predictive of difficulty in weight loss and decreased insulin sensitivity. This project aims     to study in a Mediterranean population the potential influence of genetics and food timing on     obesity, metabolic syndrome and weight loss.   "
34849|NCT02829606|"     A device has been developed that has eye trackers integrated within the Head Mounted Display     (HMD) and can remap text and images around the scotoma in real time to prevent information     loss from a central scotoma. It can also carry out other types of image processing such as     contrast enhancement and image magnification. The aim of this study is to assess the efficacy     of this device on the visual performance of participants suffering from central vision loss,     with and without remapping   "
34850|NCT02829593|"     You are invited to participate in a study designed to investigate the effects of diabetes     mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a     possible participant because you fit into one of the following categories. a) you are either     healthy and competent, are not pregnant and you have no known medical disease and therefore     your glucose metabolism will be typical of a normal person, or b) you have diabetes.   "
34851|NCT02829580|"     Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises     with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial     stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances     such as nitric oxide.      The present study assess the vascular properties of carotid and brachial arteries in children     with SCD compared with a control group without cardiovascular risk factors.   "
34852|NCT02829567|"     The purpose of this study is to determine whether motivational interviewing is effective in     improving oral hygiene in orthodontic patients wearing fixed appliances.   "
34853|NCT02829554|"     Background:      Researchers are testing new methods for research projects. They want to see how people     respond to different types of communication, including videos. They also want to learn how     people respond to life events and how they pay attention to computer tasks. They want to     learn about how various risks and threats affect the way people make decisions.      Objectives:      To learn how different stimuli and events affect the way people make decisions.      Eligibility:      Adults ages 18 and older with a U.S. computer address      Design:      Participants will be recruited online.      Participants will take one of three studies online. Each study will take about a half hour.      Participants in Study 1 will watch a short video from a popular movie then answer questions.     They will also complete 2 questionnaires. One will be about how likely they think it is that     they will experience different risks and threats. The other will be about goals for behavior     change.      Participants in Study 2 will write in detail about a life event. Then they will answer     questions. They will also complete the same 2 questionnaires as Study 1.      Participants in Study 3 will pay close attention to words and images on a computer. They will     answer questions about attitudes toward different behaviors, products, and experiences.   "
34856|NCT02829515|"     For the purpose of quality assurance, the Swedish Association for Otorhinolaryngology and     Head and Neck surgery has developed several national registers concerning ear, nose and     throat care. One of these is the National Tonsil Surgery Registry in Sweden (NTSRS). In NTSRS     patients undergoing tonsil surgery for benign indications are included. Data regarding     indication, surgical methods and techniques as well as patient reported outcomes measures are     collected. The register is designed to facilitate description of clinical activities in a     unit and help identify the need of clinical improvement programs. By compiling national data,     the register can be used to describe clinical practice in a large national cohort.   "
34857|NCT02829502|"     This randomized controlled trial investigates the effect of a single dose of glucagon-like     peptide-1 (GLP-1) receptor agonist in the subacute phase of stroke in humans. The primary     endpoint is the mean flow velocity in the middle cerebral arteries measured by transcranial     doppler and cortical oxygination measured by near infrared spectroscopy (NIRS). The secondary     endpoints are changes in endothelial/inflammatory biomarkers in the blood, changes in the     ankle-brachial index and changes in the reactive hyperaemia index measured by EndoPAT2000.   "
34858|NCT02829489|"     The purpose of this study is to evaluate the current state of nutrition care and patient     related outcomes in patients with head, neck and esophageal cancers in North America, Europe     and Australia.   "
34859|NCT02829476|"     Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to     secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the     origin of this illness. Recently, the melatonin pathway has been investigated as pinealectomy     of the chicken creates a scoliosis that resembles AIS and melatonin supplementation reverses     the process. In addition administration of melatonin to AIS patients improved the pathology.     However this hypothesis has shown controversial results. Recent studies have demonstrated     melatonin cellular resistance in osteoblastic cells from AIS patients. Melatonin acts through     G protein coupled receptor (GPCR), mainly using the Gi pathway. In AIS osteoblasts, this     pathway is blocked leading to a decrease in the inactivation of the adenylyl cyclase and     therefore maintenance of high level of cyclic adenosine monophosphate (cAMP) concentrations     in the cells. As modulation of cAMP is important for osteogenesis such resistance may be     critical for the initiation or the development of AIS.      Gi signalization is used by several other GPCR, thus, this hormonal resistance could     logically be found in other hormonal or mediator pathways. A precedent study previously     focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic     values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures     osteoblasts.   "
34860|NCT02829463|"     In this study, the investigators use the clinical documentation and imaging data of MRI to do     research. Clinical subjects were divided into two groups: osteoarthritis patients and healthy     controls without osteoarthritis. Differences of MRI data were studied between two groups.   "
34861|NCT02829450|"     The purpose of this study is to determine whether the treatment of peritoneal ultrafiltration     can improve survival and quality of life of refractory congestive heart failure with special     accent on preserving residual renal function and peritoneal membrane characteristics/   "
34862|NCT02829437|"     Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)   "
34863|NCT02829424|"     The overall purpose of this trial is to assess efficacy and safety of the combination of low     doses of Methotrexate (MTX) with anti Tumor Necrosis Factor (TNF) alpha to improve initial     efficacy and maintenance rate of anti-TNF alpha treatment in patients with psoriasis.   "
34864|NCT02829411|"     The project will test the strategy of integrating 25 hours of relationship education into an     existing employment program for low-income individuals ages 18-30. It will use a 2-arm     randomized controlled trial to test the effect of this full package of services on     participants' employment outcomes and relationship outcomes.   "
34865|NCT02829398|"     The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is associated     with large cerebral artery vasospasm, but vasospasm is not a strong predictor for DCI.     Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the     prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived     variables to be used alone or in combination for prediction of DCI   "
34866|NCT02829385|"     This study makes an observation over the objective response rate of Apatinib and XELOX     combination regimen in the first-line treatment of metastatic colorectal cancer. All the     participants will receive the treatment of Apatinib and XELOX combination regimen.   "
34867|NCT02829372|"     The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD)     of GBR 1302 monotherapy in subjects with HER2 positive cancers   "
34868|NCT02829359|"     Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related     hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA .     The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA     negative HBV-related HCC are unclear.   "
34869|NCT02829346|"     This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty     which is an alternative route of administration for blood loss reduction. Half of     participants will receive intravenous tranexamic acid injection, while the other half will     receive peri-articular tranexamic acid injection during total knee arthroplasty.   "
34870|NCT02829333|"     The purpose of this study is to verify the effect of anesthetic technique on the change of     postoperative serum vascular endothelial growth factor C and prostaglandin E2, and to explore     the potential impact of the anesthetic technique on leiomyomas recurrence and growth after     the surgery of abdominal myomectomy.   "
34871|NCT02829320|"     This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the     efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia     not using erythropoiesis-stimulating agents (ESAs). The primary objective is to evaluate the     initial response to GSK1278863 measured by hemoglobin (Hgb) levels in HD patients not using     ESAs enrolled in this study. The study is designed to evaluate the appropriateness of the     starting dose of GSK1278863 and of the GSK1278863 dose adjustment regimen to achieve or     maintain the target Hgb levels. This study will consist of a 4-week screening period, a     24-week treatment period (4-week fixed-dose period and a 20-week dose adjustment period), and     a 2- to 4-week follow-up period.   "
34872|NCT02829307|"     GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body,     and by itself, has no pharmacological action. A pharmacologically active drug can be attached     to GSK3128349 with the goal of changing the distribution and/or duration of action of the     attached drug. This study will determine the distribution and pharmacokinetics (duration) of     GSK3128349 itself after a single intravenous infusion. GSK3128349 has been labeled with and     the radioisotope 89Zirconium allowing it to be visualized in the organs of the body using a     PET scanner at multiple time points after GSK3128349 dosing. The data from this study will     help predict the distribution of future drugs attached to GSK3128349. The total duration of a     subject's participation is about approximately 10 weeks, including the screening period.   "
34873|NCT02829294|"     This is a prospective, open-labeled clinical trial. Subjects that qualify for enrollment and     provide informed consent will be treated with a novel topical cerumen (earwax) removal     product. The primary goal of this pilot study is to gain an understanding of the safety and     efficacy of this novel product.   "
34874|NCT02829281|"     Introduction: Osteoarthritis of the knee is a very common disease. However there are few     treatment options for these patients. Botulinum toxin type A is an option for chronic pain.     If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum     toxin type A can be useful for treat these patients.      Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus     Botulinum toxin type A in the treatment of patients with knee osteoarthritis.      Methods: A prospective controlled randomized double blind studied with three groups (n = 35     each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular     medication in a single moment will be undertaken. The three groups will be: Botulinum toxin     type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of     triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline     group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators      blind  in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain,     quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC     questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial     hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be     used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures .     Will be considered as statistical significance the difference of 5 %.   "
34875|NCT02829268|"     Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes     mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The     purpose of this study is to assess the safety and tolerability of dantrolene sodium in     patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium     on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta     cell functions, and neurological functions.      There is a screening period up to 56 days, a 24-week treatment period, and a 4-week safety     follow-up period. Study assessments include medical & medication history, physical exams,     neurological exams, eye exams, endocrine exams, vital signs, height, weight,     electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.   "
34876|NCT02829255|"     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,     acclimatization and re-exposure to high altitude on cerebral autoregulation   "
34877|NCT02829242|"     Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide     pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative     pain, shorter hospital stay and faster recovery. After prolonged operative time in a     Trendelenburg position rare but significant complications are a cerebral oedema or a well leg     compartment syndrome.      Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the     perfusion pressure is decreased proportionally to the lower extremity elevation. The     condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia     and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after     4 hours in a Trendelenburg position.      If not promptly diagnosed and treated, a compartment syndrome has devastating complications     like permanent dysfunction, limb loss, renal failure or even death.      There are no specific guidelines for diagnosis and for the timing of surgical decompression.     Fasciotomy is a clinical decision. There is no universal agreement at which compartment     pressure irreversible muscle damage occurs.      The only objective diagnostic tool available is currently to measure the intramuscular     pressure, however this is invasive, painful and may yield unreliable results. An     intracompartment pressure of 0- 10mm Hg is the normal range.      Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral and     somatic tissue oxygenation below the sensors and may help detecting promptly a compartment     syndrome.      Therefore, the investigators designed the present study to detect a change in the tissue     oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the     Trendelenburg position.   "
34878|NCT02829229|"     The purpose of this study is to determine the effect of the community-based obesity treatment     (PP), compared to usual care (UC), on changes in maternal weight over 12 months.   "
34879|NCT02829216|"     The objective is to measure the frequency, functionality and phenotype of bone marrow-derived     mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell     transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored     at the same time. These results will be correlated with the extent of cytopenia and clinical     graft-versus-host disease grading.   "
34880|NCT02829203|"     Frailty is an important risk factor for cardiovascular disease (CVD), recent data has shown     significant association between pre-frailty and the risk of incident for CVD, irrespective of     any classical cardiometabolic risk factors, suggesting that targeting pre-frailty as a     potentially reversible risk factor for CVD in the elderly. Patients with high levels of     frailty have an increased risk in post-operative period, with more time in mechanical     ventilation, length of stay and complications (stroke and death) compared to patients with     low frailty levels. The investigators hypothesized that pre-frailty patients also have a     higher surgical risk compared to no-frailty patients.   "
35210|NCT02824913|"     The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive     techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the     administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry     eye disease.   "
34881|NCT02829190|"     The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements     data with morphological images.      Even if the anatomy of the external carotid artery is well known, data obtained through Phase     contrast MRI could permit to progress in several fields of cranio-maxillofacial surgery as     for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive     surgery.      The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular     flow characterization branches of the external carotid artery in healthy patients and in     pathological cases.   "
34882|NCT02829177|"     The objective is to determine if lowering serum uric acid by means of allopurinol in the     course of kidney disease may be effective in preventing or improving albuminuria and renal     function in Type 1 Diabetic patients. The study is a double blinded, randomised,     placebo-controlled cross-over clinical trial.   "
34883|NCT02829164|"     Primitive kidney disease IgA, represented by Berger's disease and rheumatoid purpura     nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes     in 20 years to end-stage renal failure is described in 10 to 30 % of cases in Berger's     disease and in 15 to 20% of cases in nephropathy HSP. These two pathological entities share     biological and histological characteristics, as well as common pathophysiological mechanisms,     particularly the production of abnormally glycosylated IgA1 promoting their proliferation in     the mesangium. Tonsils part of Iga abnormal production sites that would be associated with an     infectious stimulus, tonsillectomy has been studied as a possible treatment in primitive IgA     nephropathy. The benefit of tonsillectomy is controversial: many Japanese studies demonstrate     its effectiveness in terms of reduction of proteinuria, improved renal function in the long     term regression of histological lesions and reduced risk of relapse following clinical     remission whereas European studies do not suggest its effectiveness in treating IgA     nephropathy. In this context, the aim of our study is to describe the scope of practice of     tonsillectomy in the treatment of primary renal disease in IgA child in the inter East region     and describe the short renal become Strasbourg end of the cohort that received this     treatment.   "
34884|NCT02829151|"     -  Prospective, randomized, controlled, multi-center study        -  A total of 390 subjects with critical limb ischemia will be included according to          inclusion and exclusion criteria.        -  Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP:          aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin,          clopidogrel) A group, or DAP (aspirin, cilostazol) B group.        -  All patients will be treated with angioplasty for critical limb ischemia.        -  Patients will be followed clinically for 1 year after the procedure.        -  Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be          performed at 1 year.   "
34885|NCT02829138|"     There are many health benefits associated with the consumption of omega-3 dietary fats.     Omega-3 fats, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can be     found in marine food products such as fatty fish, in fortified products such as eggs and     milk, or in dietary supplements such as fish oil. Despite numerous health benefits, it is     well documented that most people in Western society are not meeting the recommended daily     amounts of EPA and DHA omega-3 fats.      The overall objective of this study is to examine whether providing young adults (18-25     years) with personal genetic information changes behavior with regards to omega-3 fat     consumption. In order to achieve this objective, study participants will be divided into two     groups: 1. Genetic and 2. Non-Genetic. The Genetic Group will be provided with their     personalized information regarding a common gene variant in addition to general information     regarding the health benefits of omega-3 fats, while the Non-Genetic Group will only receive     the general information. Primary outcomes studied will include dietary habits and secondary     outcomes include blood markers of cardiometabolic health.   "
34886|NCT02829125|"     The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by     Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients     combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of     patients. This strategy targets multiple elements (20 items) to support pre-, intra- and     postoperative patients. This reduces the pain and the different organ dysfunction induced by     surgical stress significantly decreasing length of hospital stay, postoperative morbidity and     costs.      Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies     have analyzed the influence of preoperative exercise on postoperative rehabilitation.   "
34887|NCT02829112|"     Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually     benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic,     confirmed by MRI and confirmed by histology, there really no published diagnostic criteria     validated for this rare disease. The low number of cases reported in the literature reflects     the difficulty of studying the epidemiology of this disease, to establish and evaluate     therapeutic strategies and to assess prognosis. Work on this subject are few. To our     knowledge, no study has previously used to estimate the incidence and prevalence of this     disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in     2016 by a study capture-recapture using several independent sources of identification of     cases in order to have recent epidemiological data and learn more about this disease.   "
34888|NCT02829099|"     The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and     schedule of JNJ-64457107 when administered intravenously (IV) to participants with advanced     stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when     administered IV to participants with non-small cell lung cancer (NSCLC), pancreatic cancer     and cutaneous melanoma in Part 2.   "
34908|NCT02828839|"     The objective of the study is to assess the design features of a modified stainless steel     access needle (single use disposable) in a clinical setting and a disposable, single use,     custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. The     disposable stainless steel access needle may be used with or without the disposable needle     guide, but will always be used with ultrasound image guidance and a biopsy gun. The primary     purpose of the single-use disposable access needle is to guide the use of a biopsy gun to     obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of     the perineum. The primary purpose of the disposable needle guide is to stabilize the needle     biopsy and better approximate the most direct path to the prostate.   "
34889|NCT02829086|"     The US Committee for Refugees and Immigrants (USCRI) will be conducting an evaluation of a     healthy marriage and relationship program developed by USCRI titled Refugee Family     Strengthening (RFS) Program. This program is funded through an initiative of the     Administration for Children and Families, Office of Family Assistance (OFA).      The study is intended to measure if the identified interventions improve the well-being of     individuals and families within the refugee and immigrant population served by USCRI.     Outcomes to be measured include behavioral outcomes and perceptual changes towards healthy     relationships, family development, and positive home environment. The study will examine the     following:        1. Participants will identify utilizing healthy marriage and relationship skills.        2. Participants will report an increase in satisfaction with conflict management with          others after completion of the relationship workshop series.        3. Participants will report an increase in quality and time spent with children.        4. Participants will report an increase in economic stability.   "
34890|NCT02829073|"     The most current data indicate that tinnitus and hearing impairment are the Number 1 and 2     disabilities associated with service in Operations Iraqi Freedom and Enduring Freedom.     Tinnitus can result from exposure to continuous noise from vehicles, generators, and other     equipment, and from blast, or impulse noise from friendly-or opposing-forces weapon systems.     Thus, tinnitus caused by both long-term noise exposure and acute acoustic trauma is an     obstacle to be overcome in return-to-duty decisions and represents a serious liability to the     retention of a healthy and fit force. Until recently, there has been no treatment that has     been clinically validated as consistently effective. The development of the Neuromonics     Tinnitus Treatment sought to overcome the practical limitations of previously available     approaches (e.g. tinnitus maskers and biofeedback). While these studies have demonstrated the     efficacy of the Neuromonics Tinnitus Treatment over alternative therapies, these trials     studied target populations that may not be representative of the typical Soldier experiencing     tinnitus.      One hundred and twenty (120) Soldiers or veterans with debilitating tinnitus will be     recruited and divided into groups treated with two treatments, the Neuromonics Tinnitus     Treatment Program which includes the use of the Neuromonics Oasis™ treatment device and a     similarly-treated device using a placebo treatment. The study uses a randomized, double-blind     design. The effectiveness of the treatments will be assessed using standard audiometric     procedures and tinnitus subjective questionnaires.      This study will allow the Office of the Surgeon General of the Army to provide direction     regarding the Neuromonics Tinnitus Treatment Program (NTTP) for alleviation of debilitating     tinnitus that adversely affects Soldier deployability and operational performance. Retention     of a fit force and improved quality of life for active-duty Soldiers are important issues     associated with a successful approach to the treatment of tinnitus.   "
34891|NCT02829060|"     This study will be a multi-institutional randomized clinical trial of a short course of     pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to     undergoing percutaneous nephrolithotomy. The select patient population will be those patients     deemed to be at a moderately increased risk of postoperative infectious complications. These     higher risk patients are those with indwelling urinary drainage tubes and those with a     positive preoperative urine culture.   "
34892|NCT02829047|"     The study is a prospective, multicenter, open-label, single-arm study, to evaluate the     tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.      One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2     days, followed by one day without, one per day for 2 days followed by one day without, etc.     (14 capsules in 3 weeks).      The study will have one interim analysis.      Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a     treatment period of 6 weeks.      Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2     weeks of baseline, patients will be asked to refrain from taking any medication or supplement     to relieve their constipation.      After 14 days the patients will return and eligibility will be re-assessed. Patients will be     trained on how to use the base unit.      Patients will be instructed to complete a simple patient eDiary each day throughout the     duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and     to receive new capsules. A final visit will take place at the end of the 6 week treatment     period.      Patients will receive phone calls up to twice per week and patient compliance will be     monitored during the 8 weeks of the study.   "
34893|NCT02829034|"     This study is looking to see if giving ranolazine to subjects on stable pulmonary     hypertension therapies but with right ventricular dysfunction (RVEF <45%) will improve their     health by improving right ventricular (RV) function.   "
34894|NCT02829021|"     This study evaluate diagnostic accuracy of dynamic infrared thermography compared to     mammography (reference test) in breast cancer diagnostics. Women aged 50-70 years, selected     for assessment after mammography screening were invited to dynamic infrared thermography     before clinical mammography and further examination.   "
34895|NCT02829008|"     This is a single-center, open, randomized, controlled phase 2 clinical trial designed to     compare low-dose-bevacizumab and pemetrexed with TPC in metastatic HER2-negative breast     cancer patients after failure of taxanes and anthracycline-containing regimens.   "
34896|NCT02828995|"     The Evaluating the iNfluence of Diabetes STIGma on Medication Adherence: The ENDSTIGMA     Study was designed to develop a comprehensive diabetes stigma survey measure. The draft     measure will be piloted with approximately 50 patients visiting the Vanderbilt University     Medical Center (VUMC) Diabetes Clinic. This pilot data will be used to validate the new     survey measure and to determine if any questions in the diabetes stigma measure are     predictive of diabetes medication adherence.   "
34897|NCT02828982|"     The goal of this research is to determine the effectiveness of a powered prosthesis compared     to an unpowered prosthesis during short bouts of walking, extended periods of walking (to     fatigue), and performance in the community.   "
34929|NCT02828566|"     This study will examine the effectiveness of intranasal (IN) ketamine compared to standard     intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the     paediatric population. The aim is to assess if IN administration is equivalent to the current     standard of care, IV. The population to be studied is children 4-17 years of age who require     a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty     in masking interventions, each participant will receive both IV and IN interventions, only     one of which will be the real drug. Procedural sedation and analgesia (PSA) will be assessed     using the Dartmouth Operative Conditions Scale (DOCS).   "
34930|NCT02828553|"     There is an overwhelming amount of deconditioning that occurs during the hospitalization to a     patient admitted with a primary diagnosis of congestive heart failure. The goals of this     study are to determine if monitored activity and aggressive mobility provides improved     outcomes in hospitalized heart failure patients.   "
34931|NCT02828540|"     To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic stroke   "
34898|NCT02828969|"     Conduct disorders are defined as repetitive and persistent pattern of behavior in which the     basic rights of others or major age-appropriate norms are violated. So defined, these     disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder     management is a public health issue and a societal question. Conduct disorders affect 5 to 9%     of 15-year old boys.      Care management of children and adolescents admitted for disruptive behaviors in emergency     rooms is an issue. No consensus or official recommendation exists. However, use of emergency     care in this context is increasing in most western countries and it exposes to several risks     (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and     suicide risk). The Trajectories project is designed to describe children and adolescents with     disruptive behaviors, their care management and to follow their life trajectory and     psychiatric evolution after admission to emergency rooms. Better understanding this     population will improve their medical and social care management, thereby giving     professionals the right tools.      The main objective of this project is to implement a multidisciplinary and integrative     research combining clinical considerations and social sciences to determine the trajectory     of this population.   "
34899|NCT02828956|"     By use of several questionaires, this study aimed at an investigation of the changes in     motivation, symptoms, self-esteem and coping style in adolescent patients with anorexia     nervosa.. The psychometric properties of the Anorexia Nervosa Stages of Change Questionnaire     (ANSOCQ) and its relation to coping style and self-esteem were assessed. After a treatment     period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed.     Besides construct validity of the ANSOCQ, its predictive validity in terms of predicting the     outcome of AN was assessed.   "
34900|NCT02828943|"     The purpose of the present study is to determine the utility and effectiveness of combined     inspiratory (IMT) and expiratory muscle training (EMT) in improving ventilatory function in     people who are disabled by long-term stroke (greater than 8 months following onset) with     hemiparesis or hemiplegia. xx subjects will be randomized into 2 parallel groups in which the     experimental group will undergo combined IMT and high-resistance EMT and the comparison group     will undergo IMT with low- resistance EMT. Both training techniques involve breathing through     a tube with known amounts of resistance. Subjects will perform the breathing maneuvers for 10     repetitions, twice daily, 5 days per week for 4 weeks, in the home environment. Adherence     will be monitored by reminder telephone calls at least weekly. Outcomes will be assessed     using maximum inspiratory and expiratory pressures and standard pulmonary function testing.   "
34901|NCT02828930|"     The purpose of this single-center, open-label, non-randomized study is to assess the     excretion balance, pharmacokinetics, metabolism and absolute oral bioavailability of     [14C]-labeled idasanutlin administered orally and [13C]-labeled idasanutlin administered     intravenously in a single cohort of eligible participants. Participants will be screened for     participation in this study within 21 days of receiving the first dose of study drug on Day     1. Treatment period will continue up to Day 28 after which participants will enter 28 day     follow-up or the optional treatment extension of idasanutlin, depending on safety parameters     and as per opinion of the Investigator.   "
34902|NCT02828917|"     MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination     product comprising:        -  A mounted Cobalt Chromium (CoCr) alloy based stent        -  A Rapid Exchange (RX) Coronary System Delivery System        -  A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating        -  Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for improving          coronary luminal diameter in patients with symptomatic heart disease due to lesions in          vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.      JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient     population to show equivalence to the results of the BIONICS Trial.   "
34903|NCT02828904|"     The risk of venous thromboembolism (VTE) associated with the use of chlormadinone acetate     (CMA) is currently unknown as the available data have significant limitations and lack data     on direct comparison between levonorgestrel (LNG) and CMA containing COCs. This new study is     designed to assess the VTE risk associated with CMA containing COCs compared to LNG     containing COCs in a large case-control study.      The objective of this study is to compare the VTE risk of COCs containing CMA 2mg / EE 30µg,     compared to COCs containing LNG 0.15mg and 30µg ethinylestradiol (EE).   "
34904|NCT02828891|"     This is a single center, prospective study to calculate cerebrospinal fluid pressure (CSFp)     using a non-invasive device and assess its role in the development of optic neuropathy due to     glaucoma or idiopathic intracranial hypertension (IIH). The study also aims to assess whether     CSFp differs between untreated and treated patients with glaucoma, ocular hypertension, IIH,     and other ocular diseases that may be associated with CSFp differences.   "
34905|NCT02828878|"     Interventional, open label, Phase I/II, Safety and Proof-of-Concept Study, with a follow up     period of 180 days after the transplantation of ApoGraft.   "
34906|NCT02828865|"     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is     one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in     Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than     8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients     present with advanced or unresectable disease. In contrast, small liver cancers can be cured     with an appreciable frequency. Five-year disease-free survival exceeding 50% has been     reported for surgical resection, and for the inoperable patients who do not have vascular     invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an     alternative curative therapy. However, the main drawback of RFA is its limitation to tumor     size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels,     could not be ablated completely sometimes.   "
34907|NCT02828852|"     The objective is to compare women's platelet answer in the last month of pregnancy to women     old enough to procreate, no pregnancy and without hormonal treatment.      The hypothesis of research is that the decrease of platelet answer in pregnant women could     not only limit the occurence of embolic accidents but also explain the lowest incidence of     the arterial thrombosis in comparison with the venous thrombosis.   "
35211|NCT02824900|"     The purpose of this study is to investigate the effects of vibration stimuli to contra     lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke     patients.   "
34909|NCT02828826|"     At home, maintenance, physical performance declines more or less rapidly from 6 weeks     depending advancing age and duration of the training period . It is feared that the advice or     prescription of regular physical maintenance at the exit of the service, has only adherence     to the 50% like the medication prescribed. A US study of 2000 on the observance of healthy     living recommendations, despite the many messages promoting physical activity, shows that     only 24% of Americans aged 65 to 74 were taking physical activity regular. There are no     French-date data.      If physical maintenance is routinely recommended for the elderly living at home, so the way     to encourage these people to practice more often possible these recommendations remains     therefore a problem of public health.      The recent OSSEBO study (intervention for the prevention of injurious falls in elderly women:     background and design) recalled the interest to propose a program of physical exercise to     reduce trauma and falls in the elderly. It also shows the possibility to implement an     effective program on a long-term and large scale in France. The study allowed patients to     participate in collective sessions of physical exercises, within the framework of an     association. Patients were invited to continue their home exercises they had learned.      Also, the investigators hypothesize that the monthly telephone coaching , directed by the     physical therapist following a physical fitness exercise program which they have been trained     during their hospitalization in SSR , would allow older patients to maintain fallers their     physical performance at home for at least 6 months after leaving   "
34910|NCT02828813|"     This study investigates the neural mechanisms of motor and cognitive networks using cognitive     assessment, reaction time measurement, high-density EEG and fMRI.   "
34911|NCT02828800|"     The purpose of this study is to realize a cartography of the allodynic and hypoasthetic     territories associated with a neuropathic pain appearing in patients who underwent a Total     Knee Arthroplasty (TKA)   "
34912|NCT02828787|"     The main objective of this study is to identify by functional and structural MRI which are     the brain areas activated in various pruritic situations to deduct a model describing the     different causes of pruritus.      The investigators are going to compare two chronic pruritus conditions (histaminergic     urticaria and non histaminergic: psoriasis) to a healthy control group.      The secondary objective of this study is to specify a classification index from the     physiological results obtained by brain imaging to differentiate multiple types of pruritus.   "
34913|NCT02828774|"     Using phage libraries extensively pre-absorbed on a series of normal cell types, we will     isolate phage specifically internalized by B-CLL cells from newly diagnosed and untreated CLL     patients. Peptide sequences are then derived by Next Generation Sequencing (NGS). NGS-based     studies are contributing to an improved understanding of cancer heterogeneity in order to     tailor treatment to patients based on the individual makeup of their tumor. However the use     of NGS to derive phage displayed peptide sequences is so far rare (22). Traditionally, after     exposure to a target and recovery by elution, the phage clones are isolated by titration on     bacterial lawns. It is technically demanding and labour intensive to select and analyze more     than about 15 of the sometimes thousands clones recovered. Therefore information on other     potentially important sequences is missed. NGS allows sequencing of the entire recovered     phage pool and provides far more detailed bioinformatic analyses of peptide sequences or     motifs. RNA from the CLL cells is used for RNA-seq expression sequencing. The wide     application of NGS in combination with bioinformatics tools has begun to revolutionize cancer     research, diagnosis and therapy. The peptide and RNA sequencing data will afford     bioinformatic testing of correlations of exome expression and clinical parameters with the     pattern of peptide sequences internalized by CLL cells of different patients. This     information is crucial to answering questions 1, 2 and 3 discussed on page 1 above. The     results of this analysis will probably not allow identification of specific receptors     targeted by the peptides. The aim at this stage of the research is to identify candidate     targeting peptides. Once identified, further research will be needed to identify the     receptors to which they bind. Regarding question 4, there is currently very little published     information on the therapeutic potential of PDCs in leukemia. Using two peptides we have     isolated that target murine A20 leukemic cells, we will prepare multi-drug PDCs (using     technology we have developed) and in an animal model, test their ability to enhance the     survival and quality of life of CLL bearing animals.   "
34914|NCT02828761|"     This research asks whether coronary calcium scoring, a non-invasive test based on computed     tomography scanning, is a better way to diagnose chest pain patients than other currently     used methods. Three of four patients will undergo calcium scoring and the remaining patients     will receive standard care.   "
34915|NCT02828748|"     Chronic intestinal inflammation characterizes inflammatory bowel diseases (IBD), which     consist mainly of Crohn's disease and ulcerative colitis. The exact etiology is unknown for     both diseases and therapeutic attempts aimed at down-regulating intestinal inflammation use     both mediator-specific and nonspecific immune suppression. These attempts cause considerable     side effects. Also, IBD patients are different in their genetic background and pathology. It     was previously shown that products based on marijuana (Cannabis sativa) produce beneficial     effects for patients with IBD, and medical cannabis-based products were formerly proven to     have anti-inflammatory activity in laboratory experiments and in clinical tests. However, it     is unknown how C. sativa-based medical products exert their effect in IBD and additional     research and development should be done. One issue to be resolved in the process of     medicalization of C. sativa is the base for the differences in patient response to different     C. sativa lines, in order to fine-tune C. sativa -based treatment to IBD patients.      For this aim of fine-tuning C. sativa -based treatment to IBD patients, we characterized the     chemical composition of different C. sativa lines and their anti-inflammatory activities on     colon cells lines. Extracts of C. sativa lines were prepared using various methods and     cannabinoids and terpenoids profile was determined by chemical analysis. We found that     different compounds have different effects on inflamed colon cell lines, leading to changes     in interleukin secretion, inflammation markers and gene expression in the treated colon     cells. In addition, we have developed a unique system relevant for personalized medicine in     IBD. This system allows a patient-specific determination of the effect of C. sativa -based     treatment. Following, clinical tests will be conducted aiming to develop cannabis-based     products from different C. sativa lines, with anti-inflammatory activity that is effective     and optimized for the different IBD patients.   "
34916|NCT02828735|"     The purpose of the study is to evaluate the use of subcutaneous impedance measured with an     implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate     monitor.   "
34917|NCT02828722|"     The purpose of this study is to determine whether the environmental simulation of daytime and     night time alternation as well as by the nutrition protocol corresponding to the daily rhythm     are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU)     requiring mechanical ventilation.   "
34982|NCT02827877|"     This pilot clinical trial studies how well copper Cu64-DOTA-trastuzumab positron emission     tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab     before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive     breast cancer that has spread from where it started to nearby tissue or lymph nodes.     Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a     patient's response to trastuzumab and pertuzumab before surgery in patients with locally     advanced HER2 positive breast cancer.   "
35138|NCT02825849|"     Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial     lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to     standard therapies, present a significant clinical challenge. The aim of this trial is to     assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial     lining thickness in patients with thin lining or Asherman's Syndrome.   "
34918|NCT02828709|"     Irreversible Electroporation (IRE) is an emerging technique delivering electrical pulses to     ablate tissue, with the theoretical advantage to overcome the main shortcomings of     conventional thermal ablation. Recent short-term research showed that IRE for the ablation of     renal masses is a safe and feasible treatment option. In an ablate and resect design,     histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE targeted     renal tumors were completely covered by ablation zone. In order to develop a validated     long-term IRE follow-up study, it is essential to obtain clinical confirmation of the     efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges     verification of a suitable imaging modality. The objectives of this study are the clinical     efficacy and safety of IRE ablation of renal masses and to evaluate the use of     cross-sectional imaging modalities in the follow-up after IRE in renal tumours.      This is a prospective, human, in-vivo study among 20 patients presenting with solid enhancing     SRM on cross sectional imaging suspect for renal cell carcinoma (RCC). Preoperatively,     imaging is required through Magnetic Resonance Imaging (MRI), Contrast-enhanced ultrasound     (CEUS) and contrast-enhanced Computed Tomography (CT). Furthermore, serum creatinine levels     and VAS scores are obtained. A biopsy of the SRM will be performed in preoperative setting.     IRE ablation will be performed using CT-guidance and ablation success will be measured     directly after the ablation through contrast-enhanced CT. Device related adverse events (AE)     will be registered using the Common Terminology Criteria for Adverse Events (CTCAE) version     4.0 guideline. One week post ablation only CEUS and MRI will be performed to limit exposure     to ionizing radiation. At 3 months, 6 months and 12 months post ablation CEUS, MRI and CT     will be performed. Additionally, at these time points serum creatinine levels and VAS scores     will be obtained, and quality of life will be assessed through SF-36 questionnaires. Residual     and recurrent disease will be assessed through tissue enhancement on cross sectional imaging.   "
34919|NCT02828696|"     This study evaluates the effectiveness of a minimally invasive treatment, consisting of     partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of     rehabilitation of advanced and generalized dental wear over a period of 5 years.   "
34920|NCT02828683|"     The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster)     sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by     proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal     stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.   "
34921|NCT02828670|"     T follicular helper lymphocytes are involved in the pathophysiology of autoimmune diseases.     In humans, an increase in the proportion of circulating follicular helper T lymphocytes is     observed in systemic lupus erythematous, Sjögren syndrome. No study has yet been conducted in     patients with autoimmune hemolytic anemia. In another autoimmune cytopenia, immunological     thrombocytopenia pathogenesis (ITP), the investigators showed for the first time an increase     in circulating TFH and splenic TFH and their implication in the activation of autoreactive B     lymphocytes.      Hypothesis is that autoimmune hemolytic anemia is associated with an increase in the number     and/of function of TFH, which thus participate in the hyperactivation of B lymphocytes.      The demonstration that TFH are implicated in autoimmune hemolytic anemia will rapidly lead to     the use of targeted therapies to inhibit these cells. These treatments are in the clinical     phase of development in other autoimmune diseases.      This study is interventional because of a lots of blood sample   "
34922|NCT02828657|"     A prospective, multicenter, open-label, post-approval study of the safety and effectiveness     of ORBERA™ as an adjunct to weight reduction for obese adults (22 years of age and older)     with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2   "
34923|NCT02828644|"     This is an exploratory study to assess potential maintenance of clinical benefit (cognition     and symptoms) following 4 weeks of at-home digital therapy in ADHD children.   "
34924|NCT02828631|"     Videolaryngoscope provide better view of the larynx. This better view could improve the     navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result     in adult, one previous report using Glidescope in children did not show better performance     than direct laryngoscope. The aim of this study is to compare the performance of McGrath,     Pentax and Macintosh laryngoscope for nasotracheal intubation in children.   "
34925|NCT02828618|"     This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only,     and Part 3 is a multinational trial.      All patients with suspicion of advanced ovarian cancer are detected in the participating     study centers in a pre-screening. The study centers will register all patients with suspected     ovarian cancer in a screening log. After the patients have given informed consent, they can     be enrolled in different parts of the study.      TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En     detail, this part of the trial will evaluate if one of two strategies of timing surgery     within the therapeutic procedures may show any significant advances in terms of overall     survival over the other.   "
34926|NCT02828605|"     The purpose of this study is to test a tablet-based application called VIP Transplant,     devised to improve the recovery experience of patients that have recently had organ     transplant surgery. The study will consist of two non-randomized arms: the first arm will     consist of usual care and the second will be using the newly developed app for 21 days to     replace their in-person visits. Using questionnaires and in-app usage metrics, the research     team will track whether patients have a better medical outcome, greater patient satisfaction     with care, and greater compliance rates as compared to patients who do not use VIP Transplant     to manage their care.   "
34927|NCT02828592|"     Severe aplastic anemia is a rare and serious form of bone marrow failure related to an     immune-mediated mechanism that results in severe pancytopenia and high risk for infections     and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance     of survival; however, a response rate with just immunosuppression for those patients lacking     suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1/3 of     patients are cured, 1/3 are dependent on long term immunosuppression, and the other 1/3     relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical     donor for transplantation has good response rates and significantly lower rates of acute and     chronic GVHD.   "
34928|NCT02828579|"     Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious     diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only     effective method of achieving weight loss in patients with morbid obesity.      The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty     liver disease in patients operated on due to morbid obesity.   "
35007|NCT02827552|"     This study aims to explore prospectively the distribution of individual radiosensitivity in     the pediatric population and to determine the predictive power of individual radiosensitivity     biomarkers from an immunofluorescence technique on primary dermal fibroblasts   "
47533|NCT02663440|"     Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With     Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With     Newly Diagnosed Glioblastoma Multiforme.   "
34932|NCT02828527|"     Background / Rationale at. The mild head injury.      In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of     mild head trauma. This is a pattern of frequent use of the health system. The reason for     consultation, benign appearance, present a significant risk of complication. In 15 to 25% of     the evolution of head injury is unfavorable. Disorders of attention, memory disorders,     psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome,     post-concussion syndrome.      The post-concussion syndrome:      It affects approximately 20,000 people per year in France. This is a common disease and most     undervalued in the general population. diagnostic criteria post-concussional disorder     according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than 3     months after head injury. This syndrome is responsible for suffering, personal and     professional sound and quality of life of patients. It is particularly debilitating in     everyday life, and can have disastrous consequences on their family, social, cultural and     professional. It gives rise to many financial implications with compensation requirements and     expertise consultations.      Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has     been shown that screening and early treatment of post-concussion syndrome from the slight     head injury prevents chronicity of symptoms.   "
34933|NCT02828514|"     The purpose of this study is to determine nasal resonance change after endoscopic endonasal     transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.   "
34934|NCT02828501|"     Physical therapists frequently use spinal manipulation therapy (SMT) to treat spinal pain.     However, the methods by which SMT exerts its effects are not well understood. The aim of this     study is to assess potential changes in pain pressure threshold following both a cervical and     lumbar spine manipulation in a single treatment session at sites local and diffuse to the     site of manipulation application. This study will also attempt to determine if the order of     the cervical and lumbar manipulation application impacts pain pressure threshold changes.   "
34935|NCT02828488|"     Fragility, geriatric concept recent identification is defined by simple physical indicators.     The literature suggests that it is related to the risk of hospitalization, falls,     institutionalization and death. Some studies have shown a link with heart disease, including     heart failure. The link with the TIA (transient ischemic attack) has however never been     studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA is     unknown.      Several questions need to be asked: Among older patients hospitalized for TIA, what     proportion of those completing the criteria of frailty? In this same population, is there a     correlation between fragility and scores ABCD2 score itself predictive of the risk of     subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher     risk of ischemic stroke (which could cause a strengthening of prevention measures)?   "
34936|NCT02828475|"     This is a pilot study of surgical patients whose postoperative care will be augmented with a     personalized risk prediction platform (CALYPSO app).   "
34937|NCT02828462|"     The emergence of oral delivery in cancer therapeutics is expected to result in an increased     need for better coordination between all treatment stakeholders, mainly to ensure adequate     treatment delivery to the patient. There is significant interest in the nurse navigation     program's potential to improve transitions of care by improving communication between     treatment stakeholders and by providing personalized organizational assistance to patients.     The use of health information technology is another strategy aimed at improving cancer care     coordination that can be combined with the NN program to improve remote patient follow-up.     However, the potential of these two strategies combined to improve oral treatment delivery is     limited by a lack of rigorous evidence of actual impact.      The investigators are conducting a large scale randomized controlled trial designed to assess     the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a     web portal ensuring coordination between community and hospital as well as between patients     and navigators, versus routine delivery of oral anticancer therapy. The primary research aim     is to assess the impact of the program on treatment delivery for patients with metastatic     cancer, as measured by Relative Dose Intensity. The trial involves a number of other     outcomes, including toxic side effects, patient quality of life and patient experience . An     economic evaluation adopting a societal perspective will be conducted, in order to estimate     those health care resources' used. A parallel process evaluation will be conducted to     describe implementation of the intervention   "
34938|NCT02828449|"     Therapeutic education is an effective way to support the prescription of oral chemotherapy in     oncology. It aims to increase adherence to treatment, to better control the side effects and     reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes     region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth)     decided to collaborate on a project to implement an adapted Therapeutic Education Program     context of each of these institutions.      The objective of this study is to evaluate the implementation of the intervention in the 3     participating centers, over 1 year:        1. Assess the achievement of the target population        2. Evaluate the adaptation of intervention in context        3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life,          identification of interactions with the environment linked to the center, identification          of unintended effects of the intervention.        4. Assessing the sustainability of the intervention   "
34939|NCT02828436|"     To investigate the exercise blood pressure response during a lower-extremity dynamic exercise     in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord     stimulation reduces blood pressure during exercise in postmenopausal women and men with     hypertension.   "
35008|NCT02827539|"     The purpose of this study is to gather information comparing LessRay Enhanced fluoroscopy     with the current standard of fluoroscopy. This research is being conducted to demonstrate the     utility and effectiveness of LessRay Enhanced fluoroscopy during surgical placement of a     spinal cord stimulator epidural array.   "
35152|NCT02825667|"     Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial     therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the     observed differences on the dependent variables: range of motion, pain and physical     condition.      At the same time, the study will determine whether there are adverse effects or bleeding     complications as a result of applied physiotherapy treatment.   "
34940|NCT02828423|"     Background: The use of Enamel Matrix Derivative (EMD) when dealing with non-contained defects     may be limited, as EMD does not maintain a space itself. It has been proposed the use of     combined therapy, using a bone graft in combination with EMD to avoid the collapse of the     flap into the bony defect during the healing time. Therefore the aim of this study is to     evaluate the clinical and radiological healing response of non-contained infrabony defects     following treatment with a combination of EMD and Biphasic calcium phosphate (BC) or EMD     alone.      Methods: Fifty-two patients with at least 1 infrabony defect > 3mm in depth with a probing     pocket depth ≥ 6mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic     parameters were evaluated at baseline, 6 and 12 months after surgery. To standardize the     procedure an acrylic stent and a millimetre radiographic grid were used. The primary outcome     was the change in clinical attachment level (CAL).      Results: Analysis of the data demonstrated a statistically significant difference from     baseline within each group (p<0.05), showing a difference in clinical and radiographic     parameters at 6 and 12 months for both EMD/BC and EMD alone. However, there were no     statistically significant differences between treatment groups.      Conclusions: It was concluded that the treatment of non-contained infrabony defects with EMD,     with or without BC, resulted in statistically significant better results after 12 months when     compared to baseline measurements. In contrast, the combined approach did not result in a     statistically significant improvement.   "
34941|NCT02828410|"     This is an open label trial to test the hypothesize that serum bovine immunoglobulin protein     isolate (SBI) will improve the nutritional status and quality of life (QOL) of patients with     an ileal pouch anal anastomosis (IPAA) and symptoms of pouchitis. Subjects with symptomatic     IPAA will receive two packets of EnteraGam twice daily (total daily dose of 20 g SBI) for up     to 24 weeks. The primary objective of this study is to determine whether SBI therapy leads to     improved nutritional status and QOL. A secondary objective is to evaluate SBI in the     management of their disease, including impact on clinical symptoms.   "
34942|NCT02828397|"     Primary Objective: Determine blood concentrations of two formulations of REGN2222      Secondary Objective: Assess safety and tolerability of REGN2222   "
34943|NCT02828384|"     Background:      Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and     urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols     (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP     diet in FI patients is needed.      Aims:        1. Compare the treatment response with a low FODMAP vs. psyllium based on number of          episodes in patients with FI.        2. Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on          pre-specified clinical and quality of life endpoints.      Methods:      This is a prospective, randomized control trial of adults meeting the Rome III criteria for     FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period     and randomization, during which the severity of symptoms will be assessed and eligibility     determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total     of 20 patients will be recruited for each arm.      The primary endpoint will be treatment response based on number of incontinence episodes. A     treatment response is defined as a reduction in the number of FI episodes/week.   "
34944|NCT02828371|"     Verticalization was reported to improve the level of arousal and awareness in patients with     severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the     effectiveness of a very early stepping verticalization protocol on the functional and     neurological outcome of patients affected by disorder of consciousness due to ABI.      Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU     on the third day after an ABI. They were randomized to undergo conventional physiotherapy     alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with     robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation     unit for an individualized treatment. Outcome measures were assessed on the third day from     the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).   "
34946|NCT02828345|"     This research trial studies the levels of a type of biomarker, circulating tumor cells     (CTCs), in the blood of patients with stage I-IV melanoma. A biomarker is a biological     molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal     process, or of a condition or disease. A biomarker may be used to see how well the body     responds to a treatment for a disease or condition. Studying samples of blood in the     laboratory obtained before and after treatment from patients with melanoma may help doctors     learn more about changes that occur in CTC levels and whether they may predict how well     patients will respond to therapy.   "
34947|NCT02828332|"     Epidemiological studies have shown that a wide range of outcome trajectories exist in ASD,     but little is known about their determinant in a long-term perspective. The EpiTED cohort was     set-up in order to understand the heterogeneity of developmental trajectories among children     with a diagnosis of PDD and the role of clinical, biological and environmental factors in     their adaptive outcome. It is one of the rare cohorts involving a long term prospective     follow-up based on a large set of variables, and precise phenotypes of the entire autism     spectrum.   "
34948|NCT02828319|"     To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213     administration in patients with iron deficiency Anemia   "
35098|NCT02826369|"     Breast MRI is increasingly important in breast screening imaging. It is currently based on     dynamic sequences after contrast injection whose temporal resolution must be less than 90     seconds with dynamic acquisitions at different times.      These curves profiles are designed to differentiate benign from malignant lesions. Recently,     Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions;     lesion enhancement curves over time were more accurate than the curves usually performed.      It seems necessary to work on sequences having better temporal resolution without     compromising however spatial resolution.   "
35198|NCT02825069|"     This general population based, randomized controled trial aims at answering two major     hypotheses: First, systematic early introduction of solid foods decreases the incidence of     food allergy and dietary restrictions by the age of one year. Second, stimulation with the     symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe     allergic symptoms.   "
34949|NCT02828306|"     Patients with skull defects after craniotomy for example tumor resection, head trauma,     stroke, need a reimplantation of the bone afterwards. For some circumstances, their own bone     cannot be reimplanted due to infection, tumor infiltration, damage to the bone, or aseptic     bone necrosis. In these cases a Patient Specific Implant (PSI) needs to be designed to fit     into the patient`s skull defect.      The design of the PSI is based on the preoperative CT-scan of the patient`s head with the     skull defect, the imaging data set is uploaded and processed with IPlanNet software by     BrainLab®. With the help of the software, a 3D model of a negative mould of the PSI is     designed and printed. In the operation room, the PSI is fabricated under sterile conditions     using the PSI mould. The design of the PSI mould with the help of IPlanNet is demanding and     takes some few hours depending on the complexity of the case to be designed. In certain cases     the accuracy of the fabricated PSI mould is not optimal, so that the surgeon intraoperatively     has to adapt for the inaccuracy to achieve the best cosmetic and functional results at the     expense of the operation duration, a known risk factor for postoperative wound infection and     other perioperative complications.      Therefore, the investigators have developed an automated computer-based algorithm for PSI     design (CAPSID). With the help of this tool, an accurate PSI and its corresponding mould can     be calculated and designed based on the preoperative CT scan of the patient within 5-15     minutes and the corresponding mould can be printed. This step is automated and thus,     independent of the neurosurgeons experience and skills in 3D processing software. The mould     can be used for intraoperative fabrication of the implant under sterile conditions in the     common way as described above. The possible advantages of the clinical establishment of this     procedure would be a higher accuracy of the PSI compared to the conventional PSI fabrication     method with better cosmetic results, lower costs and faster availability and production     leading to shorter waiting time for the patient, and as a consequence of the higher accuracy     leading to shorter operation time, with a reduction of risk of operative adverse events for     the patient. Furthermore, the proof of practicability of this new method, could lead to new     concepts in the field of Computer-based Patient Specific Implants in modern medicine in     general.   "
34950|NCT02828293|"     The objective of this research project is to perform a comparative study on the in vivo     kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed     Bearing TKA and the GMK UC Fixed Bearing TKA.   "
34951|NCT02828280|"     The direct objective of this study is to determine whether an experienced provider can more     adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared     to traditional bag-valve-mask ventilation. These are approved masks, being used in the     patients routine care. The researchers believe that mean tidal volumes obtained by     experienced providers when manually ventilating anesthetized patients with the NuMask device     will be larger than when using the traditional bag-valve-mask.   "
34952|NCT02828267|"     A brief negotiational interview (BNI), administered in an Emergency Department setting for     both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's     alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-60     minute) counseling session administered by non-addiction specialists based on the concepts of     the FRAMES model of motivational interviewing. The investigators will conduct a pilot study     to test the feasibility of the study protocols, acceptance of the intervention, and patient     enrollment and retention rates, as we prepare for a fully powered randomized controlled trial     of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC)     Emergency Department.(ED)   "
34953|NCT02828254|"     The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in     patients with cirrhosis due to hepatitis C by 12-month follow-up.   "
34954|NCT02828241|"     The purpose of this exploratory study is to assess the efficacy, safety and tolerability of     DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.   "
34955|NCT02828228|"     1. Analyze the influence of vitamin D supplementation in obese children during weight-loss          program on BMI, body composition and bone mineral density.        2. Analyze the influence of vitamin D supplementation on the risk profile of          obesity-related complications, namely impaired tolerance of glucose, insulin resistance,          dyslipidemia and arterial hypertension, in obese children participating in weight-loss          program.        3. Analyze the prevalence of vitamin D deficiency among obese children.        4. Analyze the risk factors of vitamin D deficiency in obese children (age, gender,          pubertal status).   "
34956|NCT02828215|"     The objectives of this study include using the new technology of SS-OCT (swept source optical     coherence tomography) to evaluate morphological abnormalities of the vitreous, retina and     choroid and to assess the repeatability of retinal and choroidal thickness measurements in     retinal disease using SS-OCT. A secondary objective is to use the new imaging modality of     adaptive optics to directly visualize photoreceptor mosaics and microvasculature in eyes with     retinal and choroidal disease.   "
34957|NCT02828202|"     Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of     patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and     multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011     with anti-CTLA4, programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene,     serine/threonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of     advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological     studies aiming to validate and identify new prognostic and predictive factors based upon     clinico-epidemiological and histological data, genomic host and tumor alterations, tumor     microenvironment characteristics, individual immunological profile and functional imaging. In     the context of marketing of costly innovative molecules prospective collection of economic     data on treatment and toxicity are required. Large biobanks collecting data from cohorts of     advanced melanoma are mandatory for such projects.      MELBASE is a French prospective national cohort enrolling advanced melanoma patients whose     objectives are :        -  To provide an annual instrument panel with a descriptive and correlative analysis of          patients with advanced melanoma in France including epidemiological, clinical and          biological socio-economic characteristics        -  to validate and identify new clinical, epidemiological, and biological prognostic          factors such as genomic host and tumor alterations, tumor microenvironment          characteristics, individual immunological profile in advanced melanoma.        -  to evaluate the risk-benefit, the impact on treatment on patient quality of life, the          management cost of patients treated with the validated and future treatments of          metastatic melanoma. The project also aims to define predictive biomarkers of response          and toxicity including pharmacogenetics and tumor genetics alterations, tumor          microenvironment characteristics, individual immunological profile.      Patients with unresectable stage III or stage IV melanoma will be enrolled prospectively for     1 year with a 3 years follow-up (a total of 1000 patients will be enrolled) from 26 French     centers A database of clinical monitoring of metastatic patients will be established and     associated with a virtual tumor bank. This national database will be issued from the use of     biological, clinical and imaging databases already available in the centers and optimized for     this project; this database will also results from the interaction with the French national     cancer institute (INCa) genotyping platform.   "
34958|NCT02828189|"     The main objective of this study is to determine whether the proposed program of therapeutic     exercise is effective in improving fatigue and quality of life, more than the exercise     unsupervised depending on their preferences, in women treated for breast cancer.   "
34959|NCT02828176|"     The aim of the study is to investigate the effect of different angles of lateral tilt on the     maternal hemodynamics before and after spinal anesthesia   "
34960|NCT02828163|"     Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide     in the erosions of buccal mucosa of pemphigus vulgaris patients.   "
35123|NCT02826044|"     SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent     approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose     study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of     SP2086 in healthy volunteers.   "
34961|NCT02828150|"     Although it is demonstrated that nutritional support can improve clinical outcomes, the     literature shows that approximately 50% of cancer patients are not able to meet their     estimated energy requirements. Recent clinical studies suggest that a supplementary support     for parenteral nutrition (PN) could significantly help to improve the nutritional status of     malnourished cancer patients.      International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical     cancer patients if enteral nutrition is not feasible and in patients affected by severe     iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated     for more than 7 days. However, there are no studies on the effects of integrative PN in     hospitalized, malnourished, hypophagic, non-surgical cancer patients.      Recent studies have reported on the validity of bioelectrical impedance vector analysis in     monitoring the body composition of patients receiving nutritional support. Particularly,     phase angle proved to be a superior prognostic marker than other nutritional screening tools.   "
34962|NCT02828137|"     The neutrophil-to-lymphocyte ratio (NLR) has been proven to be reliable inflammatory marker     for atherosclerotic process and predictor for clinical outcomes in patients with various     cardiovascular diseases. Recent study reported elevated NLR was associated with impaired     myocardial perfusion in ST-segment elevation myocardial infarction (STEMI) patients. The     investigators sought to determine whether NLR is associated with coronary microcirculation     assessed by index of microcirculatory resistance (IMR) in STEMI patients who undergone     primary percutaneous coronary intervention (PCI). A total of 123 patients with STEMI     underwent successful primary PCI were consecutively enrolled. NLR at admission was     calculated, and the patients were divided into three groups according to NLR tertiles. IMR     was measured by intracoronary thermodilution-derived method immediately after index PCI.   "
34963|NCT02828124|"     The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in     patients with liver cancer.   "
34964|NCT02828111|"     This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to     compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in     comparison with that of vehicle in patients with Basal Cell Carcinoma. One investigational     center (metasite) in the United States will participate in this study. Approximately 36     subjects who meet the study entry criteria will be enrolled into one of four sequential     cohorts. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or     vehicle gel.   "
34965|NCT02828098|"     16 to 32 patients with aggressive solid tumors from whom biopsies can be obtained, will     receive BO-112 through IT administration.      Injected lesions must be palpable and biopsiable at the time of injection, and biopsied after     7-14 days. Patients will not receive an alternative therapy during the period comprising from     first and second biopsy. BO-112 will be administered at a starting dose. Upon confirmation of     the safety profile of the starting dose and evaluation of the pharmacokinetic (PK) profile,     three additional dose levels are expected to be tested.      During the course of the study, subjects will be examined for any side effects that may occur     (safety and tolerability).      Additionally this study will also study BO-112 biological activity, the innate and adaptive     immune system response and signaling pathways, as well as signs of clinical relevance, will     be studied.   "
34966|NCT02828085|"     Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade,     recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and     can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis     is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to     improve the diagnosis of this syndrome investigators have developed a strategy of systematic     prescription of biological tests by kit. This prescription by 'kit' strategy proved its     interest by comparison with an intuitive requirement of biological. In this study     investigators want to improve the diagnostic causative of pericarditis by implementing a new     diagnostic strategy. This new strategy includes (i) samples additional less invasive for the     patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective     diagnostic techniques: specific Polymerase Chain Reaction (PCR)   "
34967|NCT02828072|"     The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with     anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic     control in a population of patients with anxiety-depression disorders which will undergo a     specific SKY treatment.   "
34968|NCT02828059|"     A medical approach that warrants continuous and reliable local administration of non-opioid     analgesic drugs might substantially improve post-surgery pain management in CS, while     decreasing the necessity of staff-dependent invasive procedures and the probability of     untoward effects following systemic drug exposure. ReadyfusOR® is a formulation comprising a     Ropivacain-loaded single-use pump which has been approved for regional application of the     analgesic drug, also comprising obstetric interventions. There is, however, scarce scientific     information on the efficacy and benefit of this anesthetic drug formulation for pain     management following CS by means of continuous wound infiltration.   "
34969|NCT02828046|"     The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single     and multiple doses in healthy volunteers.   "
34970|NCT02828033|"     This study is an open label proof of concept study of rilonacept for patients with ANSHL   "
34971|NCT02828020|"     This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50     and 100 mg) compared to placebo for the acute treatment of a single migraine attack.   "
35028|NCT02827279|"     The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders,     affecting nearly 1% of the general population. The disorder of social interaction has often     been described as resulting from poor emotion recognition, or a bad perception of biological     motion. However, the results of studies on these issues are very divergent. The PDD also been     described as a disorder of emotion regulation, but few studies address the emotional feelings     of individuals with ASD and their neuropsychological implications.      The main objective is to study the effect of induced emotion in the children with ASD on his     visual exploration strategies.      This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy     terms of the look in a group of children with ASD, in a context of emotional induction (joy,     fear, sadness or anger) using of sound stimuli.   "
34972|NCT02828007|"     Patients with severe respiratory diseases such as chronic obstructive pulmonary disease     (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive     ventilation (NIV). Non-invasive ventilation consists of a machine (ventilator) that is     blowing air through a mask. NIV provides patients with a bigger expansion of their lung when     they are breathing. This better expansion helps patients to have more oxygen and less waste     gas (or carbon dioxide) in their body.      These improvements enhance survival and quality of life. In order to provide appropriate     ventilation for each patient, the ventilator can generate different types of blowing:        -  Continuous positive airway pressure (CPAP) which delivers a constant pressure to the          mask        -  Pressure support ventilation (PSV) which delivers a constant pressure to the mask and,          on top of that, delivers more pressure when the patient begins to breathe in.        -  Pressure control ventilation (PCV), which is similar to PSV, but use a fixed time to          generate the flow when the patient begins to breathe in.      These different types of blowing have consequences on patient comfort as well as on the     improvement of their ventilation.      To assess the improvement of the ventilation, the investigators currently use blood tests,     however, these reflect overall output and may miss more subtle changes in breathing that     could affect how patients feel.      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of     sensors around the chest that provides information on how well the lungs are being filled     with air by the ventilator. It allows a non-invasive assessment of the effect of NIV onto     lung ventilation in real-time.      The investigators hope to use the EIT technology to assess in real-time patients lung     ventilation when they are using the NIV. The investigators hope that EIT will provide them     with information on which type of blowing is more effective and more comfortable than the     others.   "
34973|NCT02827994|"     This study compared the effectiveness of pain neurophysiology education and neck/shoulder     exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).   "
34974|NCT02827981|"     Active discopathies or MODIC 1, are a diagnostic entity discovery with the contribution of     MRI in which the first cases were described by Dr. Michael MODIC in 1988. It is characterized     by a vertebral bone edema secondary to active discarthrose. Its prevalence is estimated at 6%     of the general population and up to 40% of the CLBP according to studies. Following the     discovery of this recent diagnostic entity, responsible for low back pain, the question of     its management is debate in the medical community. Early studies demonstrate the     effectiveness of corticosteroid injections in intra-disc. Other works, most recent, suggest     the contrary, infectious, incriminating a pathogenic role of certain bacteria such as     Propionibacterium acness or Corynebacterium propinquum recommending, in contrast, treatment     with prolonged antibiotic therapy. This study will aim to assess the effectiveness of     intra-disc infiltration GHPSJ carried out between 2007 and 2014. The innovation of our work     will be to assess these infiltrations in various subgroups such as patients with a previous     surgery of the spine or a history of scoliosis or spondylolisthesis.   "
34975|NCT02827968|"     This is an open label, dose escalation study to evaluate the safety and tolerability of KN035     in advanced and metastatic solid tumor.   "
34976|NCT02827955|"     Essential tremor (ET) is the most frequent movement disorder. Its prevalence is about 1/200     implying that at least 300 000 peoples are concerned in France. Its frequency increase with     age (14% of patients 65 yo). The diagnostic criteria are postural and kinetic tremor that can     be associated with head/voice tremor. ET induces a social impairment but also difficulties to     perform any task requiring dexterity. With time, tremor can be so severe that every activity     of daily living is impaired with loss of autonomy.      Treatment such as betablockers, primidone or antiepileptics might have some efficacy at the     beginning. But as the severity of the tremor increases, there is lack of efficacy. Deep Brain     stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus can be proposed.     However, in case of medical or surgical contra-indication, Gamma Knife (GK) radiosurgery     thalamotomy can be an alternative option.      Patients will be included with a minimum of 12 months after having the first thalamotomy     (Gamma Knife 1) (done on the most annoying side) subject to no significant deterioration in     cognitive assessment, voice assessment and balance and postural assessment or     neuroradiological abnormality.      Patients will be assessed with Magnetic resonance imaging (MRI) cerebral, clinical assessment     (tremor rating scale) impairment of activity of daily living, neuropsychological evaluation,     voice assessment and balance and postural assessment.      The second thalamotomy (Gamma Knife 2) will be proposed and a monitoring at M6 and M12 will     be done.      This study will demonstrate the feasibility and tolerance of bilateral GK radiosurgery     thalamotomy in ET patients with severe impairment.   "
34977|NCT02827942|"     Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan     20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg     bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1     week. Success or failure of eradication was determined by the 13C-urea breath test performed     at 1 month after the therapy.   "
34978|NCT02827929|"     The objective of this study is to determine whether the systematic education on air way     disease and inhalers in outpatient settings contributes to improve the quality of life.      Education has been known to be effective for management of chronic airway disease. However,     the real benefits remain unclear. An organized education on the chronic airway disease is     directed by primary care physicians, and the investigators evaluate the effectiveness of the     education.   "
34979|NCT02827916|"     Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer.     However, the development of neuropathic pain under treatment limits its use. These are     manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia.      It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2     channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms     of neurotoxicity are multifactorial and still imperfectly described.      Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose     challenge is to quantify / measure NAION and explained by a biochemical approach,     specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study     insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that     the expected results will be complementary to those of LIPIDOXA.   "
34980|NCT02827903|"     Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin     or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia   "
34981|NCT02827890|"     The purpose of this study is to evaluate a pharmacokinetic drug interaction between     sitagliptin and lobeglitazone in healthy male volunteers.   "
35029|NCT02827266|"     This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and     quality of life in participants with diabetes and chronic renal failure and who are not     receiving dialysis.   "
46165|NCT02681367|"     This is the first study to investigate, whether pregnancy and implantation rates would     improve in patients with recurrent implantation failure (RIF), if all embryos were to be     frozen and transferred in a consecutive natural cycle.   "
34983|NCT02827864|"     This project is designed to investigate the effects of combining tDCS and MT in patients with     subacute and chronic stroke. This project is also designed to investigate the optimal     application timing of tDCS in combination with MT in patients with subacute and chronic     stroke. Patients with subacute and chronic stroke will be recruited and randomized into one     of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT     group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of     MT followed by 30 minutes of functional task training. For the participants in the SEQ group,     20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with     MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be     placed on the scalp without actual current output. The interventions will be carried out 90     minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by     blinded evaluators before, after, and 3 months post intervention. To study the possible     interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM     groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be     performed. Additionally, the partial eta square (η2) will be calculated to determine the     effect size of interest.   "
34984|NCT02827851|"     Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic     digestion. SVF will be administered in a single dose intraarticularly 4 weeks after     arthroscopic debridement. All patients will receive cell therapy.This is a single arm study     with no control.   "
34985|NCT02827838|"     This pilot clinical trial studies how well durvalumab before surgery works in treating     patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab,     may interfere with the ability of tumor cells to grow and spread.   "
34986|NCT02827825|"     The aim of this study is to describe the population of patients admitted to the ICU in     neurosurgery for stroke requiring secondary care in intensive care and their future.   "
34987|NCT02827812|"     Parkinson's disease (PD) is a chronic neurodegenerative disease due to the loss of     dopaminergic neurons in the substantia nigra, leading to motor symptoms of tremor, rigidity,     and bradykinesia, as well as an array of non-motor symptoms that affect cognition, sleep,     behaviour, and the autonomic nervous system.      Lifelong rehabilitation measures, along with medication treatment, are the major components     of patient management. Physical exercises positively affect patients' quality of life (QOL)     and their functional capacities. Poor adherence to rehabilitation, limited patient education,     and access to specialized care can be barriers to treatment. A number of papers in fact     report that telemedicine is an acceptable means of care delivery reduces travel burdens and     may improve patient outcomes. However, most of these studies were not randomized or     controlled and did not include nursing home patients, who may benefit the most from specialty     care.      Moreover, there is no evidence supporting the use of telerehabilitation for physical     assessments of people with PD. For this reason investigators hypothesize that a home     telerehabilitation system guiding patients in following their exercise program combined with     a computerized decision-support tool monitoring patient performance, would be feasible for     and acceptable to patients with PD and would improve functional status.   "
34988|NCT02827799|"     The purpose of this exploratory developmental study is to test the feasibility,     acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I)     among adults who have stable Heart Failure. Participants were randomized either to a     treatment (CBT-I) or attention-control condition (heart failure self management education).   "
34989|NCT02827786|"     A single-centre, industry sponsored, proof-of-concept pilot study to assess the feasibility     of Electromagnetic Acoustic Imaging (EMA) as an imaging platform in the visualization of     hepatic tumours.   "
34990|NCT02827773|"     The aim of this research project is to compare the use of Talking Pill Bottles to usual     care in patients who have low functional health literacy and who purchase medications for     primary hypertension at a retail pharmacy with regard to:        1. feasibility of the procedures,        2. utility of the equipment,        3. medication adherence,        4. self efficacy in medication self management, and        5. blood pressure control.   "
34991|NCT02827760|"     The composition and metabolism of human gut microbiota play crucial roles in health.     Microbial colonisation of the gastrointestinal tract varies widely, with the large intestine     having not only the highest density of microbes in terms of bacterial cells per gram but also     the most metabolically active microbial community. Genetics, mode of birth, infant feeding     patterns, antibiotic usage, sanitary living conditions and long term dietary habits     contribute towards shaping the composition of the gut microbiome. Diet clearly has a major     impact on variation in the gut microbiota composition, and this can be detected in faecal     samples after only a few days. The bacterial metabolism of dietary components produces much     chemical diversity in the large intestine with protective or detrimental effects on disease     development.      Dietary protein levels are relatively high in western European populations, up to 103g/d, as     reported by Food and Agriculture Organization. This may result in high levels, entering the     large gut where it can become a substrate for proteolytic bacteria. Protein specifically can     provide nutrition for microorganisms but metabolites from bacterial protein breakdown can be     detrimental. Protein intake from the diet might not be the only source of microbial     proteolysis; the human body also secretes considerable amounts of protein into the digestive     lumen which can potentially be used by the microflora. On the contrary, end products of     carbohydrate metabolism can be positive for health. In this context, prebiotics are     carbohydrates that are resistant to digestion and can become available for bacteria in the     colon to produce short chain fatty acids and inhibit the production of harmful metabolites. A     switch towards more carbohydrate metabolism in the colon, at the expense of proteolysis     therefore has positive capacity through the production of more benign metabolites.      Rationale for design Prebiotics are dietary ingredients that target carbohydrate digesting     bacteria only. Given the high intake levels of protein in Western populations, they may be     useful to modulate the composition/activity of the microbial gut ecology for improved health.      Among prebiotic nutrients, inulin-type fructans (ITF) are well characterized and their     administration promotes growth of beneficial microorganisms like Bifidobacterium spp. .These     microorganisms are involved in the reduction of intestinal endotoxin concentration, improve     glucose tolerance, exert benefits upon immune function and inhibit pathogens. In healthy     individuals, ITF intake promotes satiety and modulates gut peptides regulating food intake.      The aim of the present study is to investigate the effect of inulin-type fructans (ITF) on     the negative consequences of colonic fermentation in individuals consuming high protein     diets. The hypothesis to be tested is that their action promotes carbohydrate degrading     bacteria at the expense of protein utilisers.   "
35030|NCT02827253|"     The purpose of this study is to describe brain´s morphological changes induced by chronic     kidney disease (CKD) in advanced stages (stages 4 and 5 defined by KDOQI guidelines) and also     by haemodialysis using MRI.      Based on the hypothesis that hypotension may cause damage in some organs including brain the     investigators study if intradialytic hypotension (IDH) causes any type of changes in gray and     white matter of the brain.   "
35153|NCT02825654|"     The purpose of the study is to better understand the health, including lung health, of     Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom     (OIF), or Operation New Dawn (OND) and other deployments following these Operations.   "
34992|NCT02827747|"     Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural     changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus     is 1:2000 in the general population. Oxidative stress has been thought to have a major effect     in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in     metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells     undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic     effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and     E are important antioxidants in the human body. To this date, the role of systemic     antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it     has yet to be established as to whether there is a correlation between serum antioxidant     levels, and the severity of disease in the Keratoconus patient. The investigators propose to     investigate the plasma levels of antioxidants in relation to disease severity. The     investigators will also investigate the role of antioxidant supplementation—consisting of     parenteral Glutathione (GSH), and Vitamins A, C and E—in delaying the disease progression in     Keratoconus.   "
34993|NCT02827734|"     Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges     set by the complex pathophysiology of this heterogenous group. The investigators therefore     aimed to evaluate novel or not widely used diagnostic approaches for the detection and     therapeutic monitoring of patients with various ILDs.   "
34994|NCT02827721|"     Current guideline-based criteria defining COPD do not meet the challenges set by the complex     pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not     widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.   "
34995|NCT02827708|"     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety     of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal     impairment.   "
34996|NCT02827695|"     Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject     as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled     hypertension will be enrolled into a screening phase to measure medication non-adherence.     Each subject will use an electronic pill tray for 1 month without any reminder functions     activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK     or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and     will receive attention control texts with healthy lifestyle information. SMASK will have the     reminder functions of the electronic pill tray activated and will receive a Bluetooth blood     pressure monitor and an app to collect the data and send to researchers.      Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12     post randomization. Research staff will measure resting blood pressure and heart rate.   "
34997|NCT02827682|"     The morbidity of colorectal cancer and the surgery number among elderly is growing. The     investigators need to provide more advanced and specific monitoring technology for these     patients. Index of consciousness (IoC) monitor is now widely used among endoscopy,     cholecystectomy and other common clinical applications. The investigators goal is to verify     whether using IoC monitor could help to improve the postoperative recovery after colorectal     surgery.   "
34998|NCT02827669|"     The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a     12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One     Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2     diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch     in combination with the One Drop app and Experts program, and assess whether this group is     more engaged or experiences a different impact as compared to participants who utilized the     One Drop app and Experts program only.   "
34999|NCT02827656|"     The purpose of this study is to compare two luteal support protocols in In vitro     fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome     (OHSS). We would like to determine whether luteal Decapeptyl on days 3, 6,9 post ovulation     triggering is as good as low dose hCG on day 3 post triggering..   "
35000|NCT02827643|"     The purpose of this study is to determine whether calcium and vitamin D supplement can     attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil     fumarate.   "
35001|NCT02827630|"     The purpose of this study was to evaluate the efficacy of a new digital health offering,     Proteus Discover to lower blood pressure and glycated hemoglobin in patients with     uncontrolled hypertension and type 2 diabetes.   "
35002|NCT02827617|"     The general aim of the project is the identification of dynamic molecular markers that can     help the early and real time prediction of sustained benefit or no benefit from ibrutinib     treatment in CLL harboring TP53 mutations. Specific aims of the project include: 1) Assess     whether clearance of TP53 mutated clones translates into a predictive biomarker of long term     benefit from ibrutinib treatment in CLL. 2) Assess whether plasma cell free DNA represents a     sensitive tool that can early and dynamically inform on the development of ibrutinib     resistant mutations in CLL.   "
35003|NCT02827604|"     This prospective, clinical, observational study compares preoperative and intraoperative     sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean     section.      It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and     transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.   "
35004|NCT02827591|"     This prospective, clinical, observational trial compares the measured value with quantitative     ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value with quantitative     ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the experimental     measurement done in vitro (postoperatively) of lower uterine segment of women who underwent     second cesarean section.   "
35005|NCT02827578|"     Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding     symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a     randomized, double blinded, parallel design, active controlled, multi-center, phase 3     clinical trial   "
35006|NCT02827565|"     The objective of this study is to optimize the search by next-generation sequencing (NGS)     mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic     profiles obtained with those from tumors embedded in paraffin   "
35009|NCT02827526|"     Patients undergoing major spinal surgery continue to experience moderate-to-severe pain     during the first 2-3 days following the operative procedure. Several factors contribute to     postoperative pain in this patient population. Many patients present to surgery dependent on     relatively high doses of oral opioids; this daily administration leads to tolerance to the     effects of these drugs as well as hyperalgesia (exposure to opioids makes subsequent pain     worse). In addition, surgical procedures on the spine are very painful. Furthermore, most of     the opioids used after surgery only produce analgesia (pain relief) for 2-4 hours, which     leads to fluctuations in levels of pain control (patients have to push a button to deliver     pain medication when they begin to feel discomfort). Recent data suggest that the use of a     long-acting opioid like methadone in the operating room, which provides analgesia for 24-36     hours, may improve pain control after spinal fusion surgery. However, other pain treatment     modalities are required in this patient population. Studies have demonstrated that ketamine,     a drug that prevents pain by a mechanism different from opioids, is effective in reducing     pain medication requirements when given in the perioperative period. Small-dose infusions not     only provide analgesia, but also prevent opioid tolerance and hyperalgesia. In particular,     the combination of methadone and ketamine may be especially effective in controlling pain in     patients following major operations. The aim of this randomized clinical trial is to examine     the effect of a low-dose perioperative infusion of ketamine, when given with methadone in the     operating room, on postoperative pain medication requirements, pain scores, and clinical     recovery characteristics after spinal fusion surgery.   "
35010|NCT02827513|"     The purpose of this study is to investigate the safety, tolerance, food effect,     pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of extended     release (XR) formulations of Centanafadine (CTN) in Young Healthy participants.   "
35011|NCT02827500|"     The PRIME-HF study is a multi-center, patient-level, randomized, open-label study of     approximately 450 patients with reduced (left ventricular ejection fraction) LVEF of <35% and     heart-rate >70 beats per minute (bpm) who are being discharged from the hospital following     stabilization from acute heart failure (HF) and will be randomized to a treatment strategy of     predischarge initiation of ivabradine or usual care.      All participants should have a follow-up visit within 7-14 days of hospital discharge. Heart     rate and systolic blood pressure will be assessed at this clinical visit. For participants     randomized to predischarge initiation of ivabradine and on ivabradine 5mg BID, the heart rate     may be used to adjust the dose the dose to 2.5mg BID or 7.5mg BID. For participants     randomized to usual care, ivabradine may be initiated at the provider's discretion. All     participants will have a second follow-up study visit 6 weeks (42 +/- 14 days)     post-discharge. Heart rate, systolic blood pressure and quality of life (KCCQ and PGA) will     be assessed. For participants already taking ivabradine in either treatment group, the heart     rate may again be used to adjust the dose of ivabradine. For participants not yet receiving     ivabradine, it may be initiated at the provider's discretion. All participants will receive a     90 (+/-7) day post-discharge phone call by site to assess for event status and tolerability     of ivabradine. All participants will have a final study visit at 180 (+/-14) days     post-discharge. Heart rate, systolic blood pressure and quality of life (Kansas City     Cardiomyopathy Questionnaire and Patient Global Assessment) will be assessed. The attending     physician may initiate ivabradine per usual care clinical practice.      The primary hypothesis of the PRIME-HF study is that, compared with usual care, a treatment     strategy of initiation of ivabradine prior to discharge for a hospitalization for acute HF     will be associated with a greater proportion of participants using ivabradine at 180 days.     Secondary objectives are to assess the impact of predischarge initiation of ivabradine     on:Heart Rate (Percent change in heart rate from baseline to 180 days and Median heart rate     at 180 days) and Patient-Centered Outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ)     and Patient Global Assessment (PGA)). Tertiary objectives will be to explore the impact of     predischarge initiation of ivabradine on other assessments of evidence-based implementation     of ivabradine and beta-blockers at 180 days. Evaluations will incorporate data based on     whether or not indication status was retained and whether or not an ivabradine prescription     was provided. Tolerability of ivabradine and adverse events during study follow-up.   "
35012|NCT02827487|"     Two hundred and ten women requesting IUD insertion will be randomly divided into three equal     groups. To ensure blinding the double dummy technique will be used in which group 1 will     receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo     similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in     addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to     Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour     before the procedure.      After insertion of the IUD the women's pain perception will be assessed using a visual     analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10     corresponding to the worst possible pain.   "
35013|NCT02827474|"     The purpose of this study is to determine aspects of abortion care most important to the     patient in creating a high quality abortion experience, to investigate patients'     expectations of abortion care, and to explore provider perceptions of patients' abortion     experiences and assess concordance with patients' perspectives.   "
35014|NCT02827461|"     The purpose of this study is to understand the hereditability of sleep homeostasis, i.e.,     drive for sleep by looking at monozygotic and dizygotic twins.   "
35015|NCT02827448|"     The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive     laboratory test performed on urine, predicts loss of kidney function in patients that have     had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart     (TAH) implanted.   "
35016|NCT02827435|"     Reperfusion of renal graft in kidney transplantation can change the     pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of     urine output during surgery may change the PKPD parameters of the drugs, including     elimination rate. The goal of this study is to characterize the PKPD model of rocuronium     during kidney transplantation and establish a basis for adequate dosage of rocuronium in     kidney transplantation.      Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated.     Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate     according to the step of kidney transplantation will lead to stable muscle relaxation and     fast recovery.   "
35017|NCT02827422|"     Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard     care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of     rewarming is still unknown. The objective of this project is to improve the outcomes for     patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic     hypothermia established from the analysis of multicenter registry data.   "
35018|NCT02827409|"     To determine whether performing extended delayed cord clamping in term neonates that require     resuscitation improves early transition as compared to short-delayed cord clamping.   "
35031|NCT02827240|"     ZEST is a cluster-randomized trial designed to determine whether HIV self-tests are     acceptable and improve HIV testing rates and HIV status knowledge among female sex workers in     Zambian transit towns. This study will determine whether directly giving participants an HIV     self-test or giving them a coupon to collect a test at a drug store or clinic improves     outcomes compared to standard of care.   "
35032|NCT02827227|"     The objective was to identify factors associated with the normalization of the CD4/CD8 ratio     (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined     antiretroviral therapy (cART).   "
35019|NCT02827396|"     Background: It is asserted that 85% of disabled children live in resource poor countries with     few available disability services. Measurements have shown an increase in disability     prevalence from 2% to 4% over the past three decades in Malawi. A recent prevalence study in     Mzuzu city, found 19.7% disability prevalence with associated social and psychological burden     of care; marriage disruptions and divorces among parents of disabled children due to stigma     and cultural misconceptions about disability.      Studies have shown a link between parenting children with intellectual disabilities and     parental psychological health problems and overall Quality of life. However, with     interventions, these negative impacts are not as severe as once thought.      Research Objectives: This study aims to design a Malawi specific Psychosocial Training     Intervention for parents with intellectually disabled children and assess the impact of the     Intervention in reducing psychological distress among these parents in Malawi.      Methodology: This study will use mixed methods design. It will employ an explanatory     sequential design, where by qualitative data collection and analysis builds to quantitative     data collection and analysis; and final interpretation.      The study will be conducted within catchment areas of two disability organisations that are     operating in Mzuzu and Lilongwe.      On sample size for the quantitative part, calculation using 5% level of statistical     significance, power of 90% and effect size of 0.4 [effect size found in recent meta-analysis     for similar intervention, gives 81 participants in each arm of the intervention.     Questionnaire with social-demographic data in section one; and Self-Reported Questionnaire     will be administered at baseline, 6 & 12 months follow-up. Quantitative data will be coded on     a computer, cleaned and analyzed using STATA. Mann-Whitney test will be used to measure the     impact of the intervention. Qualitative data will be analysed using content analysis with the     help of Nvivo.      All ethical consideration will be followed to ensure that subjects are treated with respect;     allow for their right to refuse participation in the study; and conducting interviews in     privacy.      Dissemination: Findings will be disseminated through Continous profesional development (CPD)     sessions at the two clinic sites; Research Dissemination Conferences in Malawi and     Sub-region; and three manuscripts submission for publication in peer reviewed journals.   "
35020|NCT02827383|"     This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate     potential for effect of fractionalized bouts of stair climbing on glucose control in adults     at risk for type 2 diabetes.   "
35021|NCT02827370|"     The purpose of the study is to determine if a targeted dietary change can enhance the effect     of neo-adjuvant chemotherapy   "
35022|NCT02827357|"     This chart review describe the response to systemic chemotherapy of patients with non-small     cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor     receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of     the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2     mutation in order to inform the design and powering of future randomized controlled clinical     trials of HER2-directed therapy.   "
35023|NCT02827344|"     Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK     rearrangement, the most attractive therapeutic perspective in the management of metastatic     lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME     DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials     with recently published positive results leading to the approval of one drug in the USA and     an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1)     expression by tumor cells is strongly associated with the response to such molecules so that     the participation in various clinical trials is currently reserved for patients expressing     this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided)     representing a considerable drag on the access to these treatments. Circulating tumor cells     (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive     access to the tumor. It has already been demonstrated that molecular characterization (EGFR,     ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the     analysis PDL-1 expression in these cells by immunocytochemistry.      Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell     functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to     test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated     to the response to these drugs.      The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1     expression on CTC   "
35024|NCT02827331|"     The question of the inclusion of periods of interruptions and periods unobservable has been     studied as part of medico-administrative databases. However, the specificity of the health     insurance databases justify the realization of dedicated methodological research. A thorough     knowledge of the purpose of these data, how they collect and restitution is an essential     prerequisite to carry out this work.      One type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis     of the comparison between the exposure groups. However, this traditional approach has the     major drawback of neglecting the changing nature of drug exposure, and therefore fails to     take into account any changes or interruptions doses. Approaches to take into account the     time dependent variables were developed. These allow to take into account any interruptions.     However, as part of study on health databases, sometimes we do not have the status in     relation to the exhibition on the entire monitoring period. This is for example the case     during hospitalization. The bias generated by the failure to take account of these periods     (non measurable time bias) can be problematic when a long exposure and chronic disorders     require hospitalization.   "
35025|NCT02827318|"     Reducing the glycaemic load (GL) of the diet may benefit appetite control but its utility is     complicated by psychological influences on eating. Disinhibited behaviour, a risk factor for     overconsumption, is characterized by reduced prefrontal cortex activity, which in turn     directly modulates vagal tone; a phenomenon inversely associated with blood glucose (BG) and     insulin levels. This double blind randomised controlled trial explores the influence of     disinhibited eating and vagal tone (heart rate variability) on the postprandial response to     GL and hunger.   "
35026|NCT02827305|"     This study evaluates the adjunctive use of Centella Asiatica (gotukola) to scaling in the     reduction of plaque and gingival inflammation. Patients were divided into three groups of     which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and     group 3 received gotukola mouthwash only.   "
35027|NCT02827292|"     This study evaluates the effect of per-operative music on the bio-molecular inflammatory     response in laparoscopic surgery. Per-operative music intervention will be given to the test     group via headphones while the control group will be applied headphones without any music     (Silent). The inflammatory stress response will be measured postoperatively at 6 hours and 24     hours postoperatively along with the baseline levels measured preoperatively. The values will     be compared between the test and control groups.   "
35137|NCT02825862|"     The investigators aim to experimentally manipulate presence of questions on positive or     negative affective attitudes to see if including these moderate as intention to become an     organ donor. The methodology will be replicated across three international sites (RCSI     Dublin, RCSI Bahrain, RCSI Perdana University).   "
35033|NCT02827214|"     Thoracolumbar (TL) burst fractures in neurologically intact patients account for     approximately 45% of all TL spine injuries. Despite being common fractures, there is     significant variability in treatment recommendations encompassing surgery and non-surgical     treatment options. The controversy regarding optimal treatment for these injuries is fueled     by several studies which suggest a potential benefit to surgical treatment in the realm of     patient satisfaction, and the overall socio-economic burden of treatment while other studies     demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study     aims to perform a prospective cohort analysis investigating the clinical outcome of various     treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A     cost-effectiveness analysis will also be performed to identify costs and benefits of each     treatment option. More specifically a sub-group analysis will be performed for this group of     patients, which have equipoise in regards to patients treatment, as decided by a blinded     review panel.   "
35034|NCT02827201|"     The main objective of this trial is to evaluate every 2 months alternating     nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the     progression of disease at 6 months.   "
35035|NCT02827188|"     The objective of the Cognitive Restructuring in ADHD: Functional Training (CRAFT) study is to     develop a non-pharmacological intervention program for children with Attention Deficit     Hyperactivity Disorder (ADHD). ADHD is a childhood onset clinical disorder of inattention,     hyperactivity, and impulsivity. The present study will investigate the validity, feasibility     and efficacy of this novel intervention.   "
35036|NCT02827175|"     Annually about 10 to 15 million international travelers from Europe visit tropical countries.     Returning from a journey, fever is the cardinal symptom of many infections. This is the     second reason for consultation (23%) for return from a trip, after digestive disorders (42%).     Urgent evaluation must always be proposed. Although that may be the manifestation of a benign     disease, fever of return can also presage a rapidly progressive and lethal disease. In 50% of     cases, patients return home, after treatment and disappearance of symptoms, though the     microorganism responsible for the pathology is not able to be identified. The prescription of     a series of systematic biological examinations in the form of a diagnostic kit has shown its     relevance and its effectiveness in improving the etiological diagnosis of endocarditis and     pericardites for optimal support. In this study we propose to assess the effectiveness of the     systematic prescription of a diagnostic kit 'fever of the traveler' to all patients     hospitalized with a fever after returning from a trip. Ready to use kit brings together in     a single bag (i) instructions for use, (ii) the tubes, bottles and jars for the etiological     diagnosis of fever of the traveler in the usual support (iii) an additional blood tube for     research of pathogens emerging.      Primary:      To assess the effectiveness of a diagnostic kit for the etiological diagnosis of fevers of     travelers on the return.      Hypothesis:      Improvement of at least 15% of the etiological diagnosis of fevers of travelers on the return     through the development of a diagnostic kit.   "
35037|NCT02827162|"     Primary objectives:        -  To assess how dengue vaccine efficacy varies across participant subgroups regarding          polymorphism in human leukocyte antigen (HLA) alleles of interest.        -  To assess the association between HLA alleles and, serotype-specific neutralization          antibody titers and summary neutralization measure in the vaccine and placebo groups.        -  To assess the association between the polymorphism in HLA alleles of interest and          susceptibility to Dengue fever and Dengue Haemorrhagic fever.      Secondary objectives:        -  To assess whether dengue serotype-specific neutralizing antibody titers and associated          summary neutralization measure at 28 days post-dose 3 are related to the rate of          occurrence of symptomatic Virologically-confirmed dengue infection after post-dose 3        -  To evaluate whether the dengue serotype-specific neutralizing antibody and associated          summary neutralization measure at 28 days post-dose 3 are related to the level of          vaccine efficacy against dengue viruses after post-dose 3.   "
35038|NCT02827149|"     Italian, retrospective, prospective, observational, multicentre, spontaneous,     non-interventional, non-pharmacological The study aims to analyze in the national Italian     experience        1. The compatibility level selected by the Italian Transplant Centres using an high          resolution HLA typing at the start of search process for hematopoietic stem cell          transplantation from volunteer unrelated donor        2. The transplant outcomes in terms of Overall Survival, Disease Free Survival, Relapse          Rate and Transplant Related Mortality and the correlation with the level of HLA matching          pairs of donor/recipient included in the Italian Bone Marrow Donor Registry and Promise          registry.        3. The possible identification of allelic mismatching combinations characterized by          increased cross-reactivity associated with higher incidence of acute or chronic          graft-versus-host disease .        4. The possible identification of combinations of allelic mismatching characterized by          higher permissiveness.   "
35039|NCT02827136|"     The primary purpose of this study is to investigate the effect of lidocaine patch on the     shoulder pain score after end of surgery.      The secondary purpose of this study is to investigate the effect of lidocaine patch on the     total number of analgesic request on ward.   "
35040|NCT02827123|"     The primary purpose of this study is to investigate the effects of McGrath MAC     videolaryngoscopy on the intubation time for orotracheal intubation in children.      The secondary purpose of this study is to investigate the effects of McGrath MAC     videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children.   "
35041|NCT02827110|"     A semi-rigid cervical collar is recommended for immobilization of the cervical spine in     patients with cervical spine injury. It has been suggested that a reduction in mouth opening     is the major contributing factor to the deterioration in the glottic view obtained.     Fiberoptic intubation is among the most versatile techniques for managing both the     anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic     bronchoscope with videolaryngoscope has been suggested to permit visual control of the     passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to     compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and     bronchoscope with pentax airwayscope.   "
35042|NCT02827097|"     The primary purpose of this study is to investigate the effect of rectus sheath block on     abdominal pain score after robotic single port cholecystectomy.      The secondary purpose of this study is to investigate the effect of rectus sheath block on     fentanyl consumption during stay of recovery room after surgery.   "
35043|NCT02827084|"     The study aims to analyze the immediate effects and 72 hours after application of the Kinesio     Taping (KT) in the electromyographic activity of the vastus medialis oblique (VMO) and vastus     lateralis (VL), the isokinetic performance of the quadriceps and referred pain of subjects     with PFPS. The volunteers will be randomly assigned to one of the three groups and perform     one of the protocols: control - remain at rest; KT - application of Kinesio Taping with     tension in the VMO region; placebo - application of Kinesio Taping without tension, in the     same region. All volunteers will be submitted to the evaluation of pain intensity, the     electromyographic activity of the VMO and VL and dynamometric parameters in 3 times: before     the application of KT, immediately after the application of KT and after 72h of application.     Average effect estimates (differences between groups) for all variables will be calculated     using the mixed model ANOVA with a significance level of 5% (p ≤ 0.05).   "
35044|NCT02827071|"     The purpose of this study is to evaluate this AngioScan angiography software on patients with     various retinal vascular disorders. The advanced OCT instrument is an FDA approved clinically     used camera, but the AngioScan angiography software is not FDA approved. Investigators would     like to know if this imaging device and software can improve the quality of images and     visualization of imaged tissues and whether they are useful in the diagnosis and treatment of     eye diseases. Images collected in this study may be compared to other images collected as     part of standard of care on the same patient (OCT, FA, AF, Fundus).   "
35045|NCT02827058|"     The purpose of this study is to determine whether injection needle pen point type 'PP Gauge     25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for     healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.   "
35046|NCT02827045|"     Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania     (maniac phase). Vestibular tests have been shown high sensibility and specificity as a     biological marker for major depression. This exploratory investigation will measure and     compare the vestibular activity of bipolar disorder patients during different phases ( 6     depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).   "
35047|NCT02827032|"     To perform post-market surveillance and evaluate the performance of the MobiusHD System in     subjects with primary resistant hypertension.   "
35048|NCT02827019|"     Motherhood Our Lady of Good Help is from the 2006 merger of three hospitals, St. Joseph, Our     Lady of Good Help and Saint-Michel. She was transferred to a new building in the heart of     Paris Saint-Joseph Hospital Group website in March 2011. The premises of the birth room are     spacious and nice. All delivery rooms are supposed to welcome the mother and child when the     birth goes smoothly. There is a resuscitation room (called Nursery) for newborns requiring     medical care. But since the installation in the new building, we had the impression that a     number of children born without pathology futures and with good adaptation at birth passed     through this room for no apparent medical reason.      We wanted to make an inventory of home practice healthy newborns in our maternity, evaluate     the reasons for a possible separation and appreciate the feelings of mothers cope with this     separation.   "
35049|NCT02827006|"     CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects   "
35050|NCT02826993|"     A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5%     and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons.     The current standard procedure is to refer the patient to the department of radiology for a     CT-colonography. In some instances the radiology department can offer the investigation the     next day, and thus in the same colon preparation. At other times they cannot, and the patient     has to go through an second colon preparation for the colonography.      A CCE procedure could be provided to the participants immediately after the failed     colonoscopy and the investigation can be completed the next morning in the same bowel     preparation without a visit to the radiology department.   "
35051|NCT02826980|"     Endometriosis is defined as the presence of endometriotic tissue outside the uterus. Its     pathophysiology is still misunderstood today, but more and more work on this pathology are     published. The clinical presentation is generally characterized by the existence of cyclical     pelvic pain, with dysmenorrhea, dyspareunia, dysuria, dyschezia.      But, there are a wide variety of symptoms, with different painful sites and different types     of pain.      The estimated prevalence of endometriosis is about 10% in women. But the impact of this     disease on quality of life and its economic impact is estimated considerable. In a US study,     the direct costs associated with endometriosis were estimated at US $ 2.801 per woman. Some     studies have focused also to quantify work absenteeism associated with endometriosis.      The etiology of endometriosis is based on the migration of endometrial fragments reaching the     pelvis via the tubes and establishing themselves on other sites, thus creating non cyclical     uterine pain. Catamenial pace of pain is suggestive of the diagnosis, but with time, the pain     tends to be chronic rather than cyclical. The standard diagnosis is based on visualization     and histological examination of the lesions.      The wide variety of symptoms of endometriosis often leads to wandering and medical diagnostic     delay. A better understanding of this disease by the medical community would allow better     management of these patients. Currently, endometriosis remains a misunderstood disease by     rheumatologists. However, the initial presentation may mimic rheumatologic symptoms; thus,     rheumatologists may face this disease.      The purpose of this study was to determine the prevalence and characteristics of     manifestations of endometriosis in a cohort of patients with a recent diagnosis of     endometriosis established. Secondly, it may well be possible to establish a list of symptoms     and signs suggestive of endometriosis for the rheumatologist, allowing to contact a     specialized consultant gynecologist some patients by mistake in rheumatology.   "
35052|NCT02826967|"     This study will allow investigators to determine whether colonic irrigation may allow for a     non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could     lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus     increased cancer prevention and early detection.   "
35061|NCT02826850|"     This project is one of four components of a thematic project that aims to evaluate the use of     ultrasound in regional and infiltration blocks, called Use of ultrasound in regional blocks     and infiltration for the treatment of acute and chronic pain.      It aims to evaluate quantitatively and qualitatively the knee pain control in patients with     osteoarthritis after neurotomy by saphenous nerve radiofrequency guided by ultrasound ,     compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy .      Differences between total consumption of analgesics, side effects of medications , impact on     quality of life and functional capacity in patients undergoing saphenous nerve neurotomy by     radiofrequency guided by ultrasound compared to neurotomy by radiofrequency of genicular     nerves guided by fluoroscopy, will also be evaluated.   "
35062|NCT02826837|"     A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of     LEAC-102 in Combination with FOLFOX + Bevacizumab/Cetuximab in Subjects with Advanced     Colorectal Cancer   "
35053|NCT02826954|"     The study is based on the theory of a unified airway that considers the nose and paranasal     sinuses together with lower airways as one integrated unit. The upper and lower respiratory     tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes     in one portion of the airway, can provoke similar changes throughout the airway. This is well     documented in asthmatic patients but documented poorly in patients suffering from chronic     obstructive lung disease (COPD).      COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal     involvement has been found to directly affect the lower airway, sinonasal disease is     under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger     project where the goal is to gain knowledge supporting the theory of a unified airway in     patients with COPD.      Here sinonasal, pulmonary and generic health related quality of life will be studied in a     group of patients with COPD versus a control group. The severity of nasal airway obstruction     will be linked to the the severity of pulmonary airway obstruction. Assessment of     pathological changes in the nose with nasal endoscopy, as well as performing a nasal     cytological brushing for the identification of nasal inflammatory responses in the nose, will     be conducted in both the control and study group.   "
35054|NCT02826941|"     This study was a multicenter, randomized, controlled pilot trial of moderate systemic     hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal     encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.   "
35055|NCT02826928|"     Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the diagnosis     and follow-up of patients with small-intestine neuroendocrine tumors. Although this marker     has good specificity, its sensitivity is moderate and its dosage is constraining, since it     requires urine collection over 2-3 days and specific diet. Preliminary data suggested that     overnight 5HIAA value may be representative of 24-hour 5HIAA value, and that plasma 5HIAA     dosage could be a valuable alternative to urine 5HIAA dosage. The main objective of this     study is to compare sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value     and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors.   "
35056|NCT02826915|"     Epilepsy in children is a major public health issue. It is the first neurological disease of     the child. The specific incidence of epilepsy rates were highest during the first year of     life, between 75,105 and 250,105 hab.an hab. year and remain high in the age group between 0     and 10 years. Epilepsies predictions are varied. They can be spontaneously benign, drug-,     chemically dependent or drug-resistant. These, refractory epilepsies, represent 20% of     epilepsy as a child and adolescent than adult is about 1200 children and 1200 adults Picardy.     The validation of non-invasive investigative tools is becoming a necessity in the management     of drug-resistant epilepsies especially when a surgical decision is envisaged. The aftermath     (motor, cognitive, sensory) appear to rule early; but they are sometimes limited to learning     deficits detected later in the school curriculum. The investigators know that defects in     neuronal electrical activity (eg critical discharges) induce a metabolic response and     conversely metabolic disturbances can cause abnormal electrical activity. It is therefore     important to have tools to better characterize the interactions between these two mechanisms     to better understand brain function in the brain during development and during pathological     situations. The investigators lack quantitative criteria regarding the impact of crises on     the metabolic activity and thus predictive criteria consequences of crises on brain function.     The deleterious hazard must be considered at all ages in both structures to causing seizures     than in those where the crisis spread. The functional characterization, electrical, metabolic     and anatomic pathology of these networks is necessary and contributes to a better     understanding of physiological and pathological brain function, and helps to define the most     appropriate treatment strategy.      About childhood epilepsy, analysis of the EEG allows in 75% of cases to find predictive     patterns characteristic of becoming. However in 25% of cases, we lack predictive objective     criteria. This highlights the importance of developing analysis tools for more accurate and     efficient brain function and to improve the management and evaluation of the prognosis of     these children.   "
35057|NCT02826902|"     The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the     quality of recovery from surgery has been reported in several different types of operations.     The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess     the degree of recovery after anesthesia and surgery, and has been validated in previous     studies. Limb lengthening surgery is unique in that it is usually purely cosmetic, and the     patients are mostly young and healthy patients. The present study aims to compare the quality     of recovery with the QoR-40 questionnaire, in patients undergoing bilateral limb lengthening     surgery under general anesthesia with either TIVA with propofol or inhalational anesthesia     with desflurane.   "
35058|NCT02826889|"     Appropriate fluid management is an important part of anesthesia in patients undergoing     surgery, and several dynamic indices have been suggested to have high predictability for     fluid responsiveness in patients receiving mechanical ventilation. Among various surgical     positions, the prone position is known to cause unique physiologic and hemodynamic changes     and affect the predictability and cut-off values of dynamic indices for fluid responsiveness.     A previous study reported that pulse pressure variation (PPV) and corrected flow time were     able to predict fluid responsiveness with relatively high accuracy in patients undergoing     spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known     to have less effects on the cardiovascular system compared to the Wilson frame, and therefore     may be physiologically more appropriate in patients undergoing surgery in the prone position.     The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in     patients under mechanical ventilation. The present study aims evaluate the validity of PPV     and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and     prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson     table.   "
35059|NCT02826876|"     Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use     of narcotic drugs.   "
35060|NCT02826863|"     This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the     efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric     and young adult subjects with Dravet syndrome. Subjects who qualify for the study will be     randomized (1:1:1) in a double-blind manner to receive 1 of 2 doses of ZX008 or placebo. All     subjects will be titrated to their randomized dose over a 14-day Titration Period. Following     titration, subjects will continue treatment at their randomly assigned dose over a 12-week     Maintenance Period. Total treatment time from the beginning of the Titration Period through     the end of the Maintenance Period is 14 weeks.   "
35092|NCT02826447|"     This project is a prospective observational cohort study to quantify the risk of acquiring     Hepatitis C virus (HCV) infection for patients and healthcare workers in Ain Shams University     Teaching Hospital, Cairo, Egypt through: 1) identifying typical patient trajectories within     the hospital; and 2) assessing the ward-specific risk based on the type and number of     procedures performed and the prevalence of HCV viremia in patients within each ward.   "
35063|NCT02826824|"     The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the     general population. This malformation is mostly diagnosed prenatally by ultrasound, usually     at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.      Several studies in recent years have helped to define the determinants of prognosis for the     unborn child suffers from agenesis of the corpus callosum, whether total or partial. These,     mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no     other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning     or viral seroconversion when pregnancy) is associated with favorable developments in terms of     psychomotor development in 80% of cases Similar results were also found in prospective     studies, while the associated nature of the defect seems most heavily encumber the prognosis     as other malformation or syndrome associated with agenesis of the corpus callosum Although     these recent data have already significantly influence prenatal counseling and outcome of     pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis     of the corpus callosum are still valid.   "
35064|NCT02826811|"     BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation.      In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is     the main strategy that has proven effective in reducing the risk of BKVN. However, it exposes     a transplant rejection risk estimated between 4 and 14% according to studies.      Despite the pre-emptive reduction of immunosuppression, a significant number of patients     continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's     therefore urgent to develop new prognostic markers to identify earlier and more effectively     patients with a higher risk of developing BKVN.   "
35065|NCT02826798|"     The purpose of this study is to compare the safety and effectiveness of four different doses     of cytomegalovirus vaccines in healthy adults.   "
35066|NCT02826785|"     This study investigates the feasibility of a cognitive strategy training intervention for     people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to     complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire     study duration per participant = 8 weeks). We will measure participant responsiveness and the     overall efficiency of the intervention process.   "
35067|NCT02826772|"     This study is an open-label, non-randomized, dose escalation study in subjects with     metastatic castrate resistant prostate cancer (mCRPC) who progressed after both hormonal     therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel), or cannot tolerate either     or both therapies.      There will be two treatment phases:      Phase 1 (dose escalation stage): Multiple dose escalations of GT0918 (proxalutamide) to     establish safety and tolerability.      Phase 2 (dose expansion stage): Identify two dose levels from Phase 1 to further evaluate the     safety, tolerability and antitumor activity of GT0918 (proxalutamide); subjects will be     randomized into the 2 treatment arms.   "
35068|NCT02826759|"     This study is designed to compare the serum sphingolipidomic analyses in healthy,     pre-diabetic and diabetic subjects. age, sex and BMI are matched among these three groups. As     ceramide, sphingosine, sphingosine-1-phosphate and sphinganine are involved in inflammation,     immunity and cancer, investigators proposed a hypothesis that sphingosine-1-phosphate and     other sphingolipids may be associated with the progress of type 2 diabetes. sphingolipids may     be a biomarker for diabetes.   "
35069|NCT02826746|"     The primary purpose of this study is to investigate the effect of intravenous magnesium on     postoperative throat pain after thyroidectomy.      The secondary purpose of this study is to investigate the effect of intravenous magnesium on     total dose of fentanyl in recovery room after thyroidectomy.   "
35070|NCT02826733|"     Many cognitive functions in human are based on asymmetric brain networks. For most adults,     language is processed largely by the left hemisphere while other auditory treatments, such as     voice recognition are rather based on the right hemisphere. Many studies helped to highlight     the presence of anatomical and functional asymmetries both in the first months of life. What     are the causes of these imbalances? How do they develop? Are they necessary for operation or     for effective learning?      The investigators would like in this work, in collaboration with applied mathematics team of     Compiègne and INSERM team, to determine from which period the development of hemispheric     dominance is set up for recognition of language and in which brain structure it occurs in     preterm infants whose sound environment is usually very different from that of the fetus. The     impact of this environment on brain development of infants and their early learning will be     assessed.   "
35071|NCT02826720|"     The aim of present study is to investigate any relationship between hyperlipidemia and     periodontal disease regarding the periodontal parameters and plasma lipid parameters, along     with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol     consumption.      In this cross sectional study, a total of 160 individuals were divided into two groups based     on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63).     Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical     attachment level (CAL) clinical parameters and community periodontal index of treatment needs     (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density     lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had     been determined previously during individuals routine systemic examinations. Daily brushing     habits and interdental cleaning together with dietary habits, alcohol consumption and     physical activity levels were also recorded.   "
35093|NCT02826434|"     The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and     Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or     III Triple Negative Breast Cancer. This research study is studying the safety, tolerability,     and immune response of these treatments.      The names of the study interventions involved in this study are:        -  PVX-410 Vaccine        -  Durvalumab (MEDI4736)   "
35094|NCT02826421|"     The purpose of this study is to compare corneal incision size after IOL implantation with the     use of one of four IOL delivery systems (three preloaded IOL delivery systems and one     manually loaded IOL delivery system).   "
35378|NCT02822729|"     The purposes of this study are to evaluate the long-term safety and intraocular     pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of     DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle     glaucoma or ocular hypertension.   "
35072|NCT02826707|"     Despite physical activity (PA) being a valuable modality for promoting health, the evidence     for effective PA intervention strategies for manual wheelchair (MWC) users is underdeveloped.     Community-based programs and telephone-counselling interventions to increase PA among MWC     users have had some success, but the uptake and adherence to these interventions remains low     within this population. Community-based programs may not reach MWC users who live in rural     areas and have issues with transportation, while health professionals may not optimally     relate with MWC when providing telephone counselling. Although the PA needs of MWCs are not     fully understood, there is reason to believe that including peers into intervention delivery     may have benefits.      A feasibility trial is critical and prudent prior to moving forwards with a large and     expensive multi-site randomized controlled trial (RCT) to ensure that: the intervention meets     the needs of the target population; the right outcomes are measured; and that the     intervention is feasible to administer.      The objective of this study is to evaluate the feasibility of a Smartphone-delivered Peer-led     Physical Activity Counselling (SPPAC) program for MWC users.   "
35073|NCT02826694|"     The NC NEXUS research study is exploring the utility of next generation sequencing in newborn     screening and parental decision making. The National Institutes of Health (NICHD and NHGRI)     are co-funding this study under a single U-19.   "
35074|NCT02826681|"     Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750     mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency     anemia (IDA).      Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior     FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS     symptoms worsen or reoccur.   "
35075|NCT02826668|"     The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success     rate and efficiency of labor epidural placement in the lateral position. The investigators     hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield     similar ultrasound results when done immediately prior to epidural placement. The     investigators also hypothesize that the use of ultrasound with landmarks marked and depth to     the epidural space estimated will facilitate epidural placement in terms of both efficiency     (time required for placement) and efficacy of pain relief.   "
35076|NCT02826655|"     This is a feasibility study to assess the use of wide field adaptive optics optical coherence     tomography (WF-AO-OCT) to determine whether there are structural differences in the     peripheral retina in participants diagnosed with diabetic retinopathy compared to a healthy     control group. This study being conducted under an abbreviated IDE. The investigators will     analyze data using descriptive statistics. Risks related to light exposure will be managed by     ensuring that the exposure to the WF-AO-OCT light source is well below maximum permissible     limits for safe exposure.   "
35077|NCT02826642|"     The purpose of this study is to evaluate the safety, tolerability and potential efficacy of     IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia     (AML).   "
35078|NCT02826629|"     The investigators recently showed that visuomotor integration was significantly altered in     schizophrenic patients during: (i) a grip force task (Teremetz et al., 2014), and (ii) a     saccadic paradigm (oculomotor task)(Amado et al., 2008). Given this findings, the     investigators propose a combined study of oculomotor and grip force control to better     characterize the sensorimotor integration deficit. This approach may allow for identification     of behavioural biomarkers of vulnerability to develop schizophrenia.   "
35079|NCT02826616|"     Giving preoperative loading dose of 60mg of trimetazidine can safely and effectively reduce     the PCI-related myocardial damage for the patients undergoing selective PCI. but the effect     of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation     myocardial infarction is not sure. this study aim to study the effect of Trimetazidine during     the primary PCI on cardiac function in patients with ST-elevation myocardial infarction.   "
35080|NCT02826603|"     Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe     plaque psoriasis.   "
35081|NCT02826590|"     This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the     neck, neck muscle electromyography and sympathetic nervous system activity in people with     neck pain.   "
35082|NCT02826577|"     No studies to date have examined the effects of pregnenolone on hypervigilance for social     threat in individuals with perceived social isolation (PSI). We therefore are conducting a     double-blind randomized research study combining three validated behavioral paradigms on     social threat attention, perception of others, and emotion regulation with high-density     electrical neuroimaging to probe the neuro-circuitry of social threat processing in young     adults high in perceived social isolation two hours after the oral administration of 175mg     pregnenolone (N = 24), 400mg of pregnenolone (N = 24), or placebo (N = 24). Such research has     the potential to yield important insights into the neurobehavioral mechanisms of pregnenolone     on hypervigilance for social threat and perception of others--- a first key step toward the     development of adjunctive pregnenolone therapy in individuals with PSI.   "
35083|NCT02826564|"     The goal of the proposed research project is to assess the safety (dose limiting toxicity,     DLT) of the combination of pembrolizumab and high-dose stereotactic body radiotherapy (SBRT)     in patients with metastatic urothelial cancer. Both the SBRT dose and pembrolizumab dose will     be fixed, but the timing of the combination will be varied. Secondary objectives include     response rates, local control, progression-free survival (PFS) and overall survival (OS).     Exploratory endpoints include immunologic responses and response rates in PD-L1- TIL- tumors.     The combination sequence with the most promising response rates and the best safety profile     will be selected to continue in a Phase II trial.   "
35095|NCT02826408|"     Palpitation is a common complaint. Patients frequently feel this symptom despite having     normal rhythm during symptoms. I have seen many patients who improve significantly on     treatment with proton pump inhibitors (PPI). It may be that gastritis provokes a feeling of     discomfort that subsequently starts the feeling of palpitation. On searching literature I     found no study that investigated the effect of PPI's on palpitations. Therefore I propose a     study where the investigators randomize people with palpitations with normal heart rate (no     arrhythmia) and no apparent cause such as anxiety or clear illness to receive either PPI or     placebo. The result will help to investigate if the improvement is true and if the results     are positive this can provide a simple treatment for a common problem.   "
35084|NCT02826551|"     Post-operative pain control following elective anterior cruciate ligament reconstruction     continues to be a hurdle for orthopaedic surgeons. This obstacle becomes particularly     problematic during the first 36 hours after the operation, when the patient is experiencing     pain at its peak intensity. Good control of pain leads to better patient comfort, confidence     to place weight on the operative limb and improved ability to perform critical exercises in     this period to improve joint range of motion.      A variety of anesthetic techniques have been employed to reduce pain including: cryotherapy,     systemic analgesic and anti-inflammatory drugs, intrathecal, regional blockade of peripheral     nerves and frequently intra-articular injections. Each technique has been studied at length     with mixed but overall favorable results. However, in the authors' experience, after femoral     nerve blockade, patients continue to complain of posterior knee pain in the Post-Anesthesia     Care Unit (PACU) and peri-operative period. Intra-articular injections comprised of morphine     and other Na-channel blocker analgesics may curb some of this pain by bathing the posterior     capsule in anesthetic. However, there is still a large concern amongst orthopaedic surgeons     about the potential harm these agents may have on the knee's healthy articular cartilage     surfaces. The long term effects, including chondrolysis have been documented in the shoulder     and while in the short term this effect is diminished there is still hesitation among     surgeons to use this form of pain blockade.      This has led the investigators to adapt a technique of isolated posterior capsular injections     after total knee replacements from the joint arthroplasty literature, which has shown     favorable results with low complication risk. The investigators plan to study the     effectiveness of this technique during ACL reconstruction in an attempt to curb the amount of     posterior knee pain and decrease the overall narcotic use postoperatively while limiting the     exposure of the native cartilage to harmful agents.   "
35085|NCT02826538|"     Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with     patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis     fractures compared with the standard procedure of fracture fixation.   "
35086|NCT02826525|"     This is a phase I/IIa, randomized, single-blind, placebo-controlled, multiple-ascending dose     study conducted at a single site. The study plans to include up to approximately 46 evaluable     subjects with Type 2 Diabetes Mellitus (HbA1c 7-11%) and Non-Alcoholic Fatty Liver disease     (liver fat content > = 8%) on metformin monotherapy.      Three initial cohorts are planned:        -  Cohort 1: 6 subjects receiving AZD4076 and 4 subjects receiving placebo        -  Cohort 2: 12 subjects receiving AZD4076 and 10 subjects receiving placebo        -  Cohort 3: 10 subjects receiving AZD4076 and 10 subjects receiving placebo, with the          possibility to add additional subjects if drop-out rates are higher than expected      Pending review by SRC, an additional 2 cohorts, each consisting of 18 evaluable subjects may     be included in the study.      The primary objectives of this clinical trial are to investigate the safety and tolerability     of AZD4076 following subcutaneous administration of multiple ascending doses; to assess the     effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp     with tracer technique; and to assess the effect of AZD4076 on liver fat content using     magnetic resonance imaging. Secondary objectives of this trial are to characterize multiple     dose PK of AZD4076 and its longmer and shortmer metabolites and assess the time required to     reach steady state and the degree of accumulation; to assess the efficacy of AZD4076 on     24-hour glucose; and to assess the effect of AZD4076 on homeostatic model assessment insulin     resistant (HOMA-IR) and Matsuda index.   "
35087|NCT02826512|"     Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be     treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or     patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a maximum     of one prior line of treatment for incurable disease will be treated with Niraparib until     disease progression   "
35088|NCT02826499|"     Pedicular screwing has become the gold standard for intervertebral fixation required in     degenerative, scoliotic, tumoral pathologies or for fractures. Several pedicular screwing     methods exist.      The free hand pedicular screwing requires a high learning curve and has, as a consequence, a     high malposition rate.      The placing of pedicular screws under fluoroscopic control is the most common technique as it     is both reproducible and accessible. It is a two dimensional imaging technique. The profile     incidence at the level of the spine is mostly used to spot the vertebral pedicle and the     direction of the screw in the sagittal plane. However, there is no real control of the     direction of the pedicular screw in the horizontal or frontal plane. The screw malposition     rate is less important than with the 'free hand' technique but remains none of the less     significant. Furthermore, fluoroscopy is an irradiating imaging technique, both for the     patient and the staff.      New revolutionary techniques as the tridimensional navigation and the per-operatory     tomodensitometry appeared in the last few years. The techniques give the best results when     used concommitantly. The material has the advantage of being very precise. The pedicular     screw malposition rate is minimal after a three-dimensional localisation. However, those     systems require qualified staff and expose the patient and the nursing team to high radiation     levels. The costs are higher and the surgery duration is globally longer. It is thus     difficult to implement this technique in each belgian hospital.      Finally, the Pediguard technique appeared on the market. It is a guide for the perforation of     the pedicular channel, with a probe at its extremity. This probe allows a real time     measurement of the electric conductivity of the tissues that are being crossed. The     conductivity measure is translated in a sound signal. Because the cortical bone has a low     conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a     medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the     event of a breach in the pedicular cortical, as blood and periost have a high conductibility,     the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to     anticipate a cortical effraction, by detecting the proximity of the cortical wall. It is     efficient but remains relatively expensive.      The main objective of this study is to determine the precision of the placing of pedicular     screws, with and without Pediguard system, under fluoroscopy.   "
35089|NCT02826486|"     This study will assess the efficacy and safety of BL-8040 as a single agent and in     combination with pembrolizumab (Keytruda®) in subjects with metastatic pancreatic     adenocarcinoma.   "
35091|NCT02826460|"     A retrospective chart review in which the information in the standard psychosocial     evaluations done pre-transplant for liver transplant recipients will be coded, recorded, and     correlated with posttransplant outcomes of the same recipients. Evaluated outcomes include     rejection episodes and adherence to tacrolimus, calculated through the MLVI (Medication Level     Variability Index). The researchers will evaluate the degree to which both single elements in     the evaluation as well as a cumulative score derived by a structured review of the chart     using the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) model can     predict posttransplant outcomes.   "
35099|NCT02826356|"     Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and     angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments     is challenging because they are expensive and have short shelf lives making it illusory that     all emergency department (ED) stock them. The aim of this retrospective study was to define,     for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care,     the specific treatment was administered. The second objective was to analyse the availability     of these treatment in the area around Lyon, France and the factors that may influence it.   "
35199|NCT02825056|"     There is paucity of literature on the effects of intrathecal morphine on the postoperative     hemodynamics in the cardiac-surgical patients.We planned this study to compare the     post-operative hemodynamic effects (particularly the incidence of vasoplegia in the two study     groups) and outcome of combined general anesthesia + high spinal block, with or without     intrathecal morphine in patients undergoing cardiac-surgical procedures in our set up.   "
35100|NCT02826343|"     First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic     resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the     University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and     optimized for the equipment at UVA. These sequences will need to be evaluated in healthy     adults for comparison with results obtained and in adults with lung diseases to optimize the     sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to     be optimized for the parameters of a human MR coil and the gas exchange characteristics in     healthy and diseased lungs.      Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to     monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting     beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of     the current COPD therapeutics. The investigators will characterize the functional changes of     the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment     after a three-month trial. Also the investigators will compare corresponding results obtained     by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic     contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography     (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators     anticipate that the results from this project will greatly improve the investigators     understanding of the lung functional responses of COPD subjects to current therapeutics.     Also, the investigators expect that this project will provide evidence to consider Xe129 MRI     as a diagnostic strategy to assess and monitor therapeutic responses of existing and new     pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in     the future   "
35101|NCT02826330|"     Transversal multicentric French study on the microbiota in patients with Crohn's disease and     their first degree healthy relatives The primary objective is the comparison of microbiota     between patients with CD, healthy controls non genetically linked and first degree healthy     relatives of patients with CD.   "
35102|NCT02826317|"     Chronic postsurgical pain (CPSP) is defined by pain persisting longer than 2 months after     surgery (1). Its incidence varies from 10 to 50 % in the literature (2). A high proportion of     CPSP is neuropathic (CPSNP) (4). Postoperative pain is traditionally classified as     nociceptive pain and the more intense is this pain on a numeric pain scale (NPS), higher are     the risks of pain chronicization and the duration of the severe pain is longer (5,6).     However, acute neuropathic pain (ANP) can be present in the postoperative setting. However,     data on the prevalence of ANP immediately after surgery are scarce and no screening tool has     been validated so far in this setting. Therefore, the first objective of this multicenter     observational study is to prospectively describe the incidence of APSNP in a large population     using the DN4 questionnaire. The second objective of our study is to confirm the hypothetic     link between APSNP and CPSNP at 1 and 2 months after surgery in a large population. It is     hypothesized that the systematic use of the DN4 questionnaire in postoperative could help     detect patients at risk of CPSNP.   "
35103|NCT02826304|"     The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal     hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and     Postoperative outcomes   "
35104|NCT02826291|"     The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with     histological ultrastaging examination in the sentinel lymph node assessment in patients with     endometrial cancer.      The molecular biologic method OSNA is a modern way of metastatic spread detection in     lymphatic nodes using quantitative reverse transcription polymerase chain reaction.     Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker     (detected by OSNA).      The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could     help to improve the standards of care in endometrial cancer patients.   "
35105|NCT02826278|"     Normal values for female external genitalia size at birth, particularly clitoris and blood     level of androgens are not well known. This study's aim is to collect normal values in 180     newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts according     to gestational age and birth weight.      The investigators will measure clitoris, genito-anal ratio using a small plastic caliper, at     birth, and their evolution until Day 3 of life (if the child is still at the hospital).      The investigators also want to establish normal values of blood testosterone,     17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol,     deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone),     using samples taken for systematic post natal screening of diseases (only in new born of 35     or more weeks of birth).      This is an observational prospective study.   "
35106|NCT02826265|"     Current diagnostic tools used in pulmonary disease often do not meet the challenges set by     the respective pathophysiology. The investigators therefore aimed to evaluate novel or not     widely used diagnostic approaches for the detection and therapeutic monitoring of patients     with various pulmonary diseases.   "
35107|NCT02826252|"     The aim of this study is to examine inhalation behavior in patients enrolled in the German     Ventavis patient support program Ventaplus when these patients are switched from Ventavis     (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.   "
35108|NCT02826239|"     The investigators aim to evaluated the effect of postural changes on novel lung function     parameters derived from multiple-breath-washout.   "
35109|NCT02826226|"     The investigators aim to evaluate the effect of bronchodilatator testing on     multiple-breath-washout derived lung function parameters.   "
35110|NCT02826213|"     Comparison of two techniques of renal pre-transplant infusion on the evolution of renal     function in the recipient: multicentre randomized trial   "
35111|NCT02826200|"     The RETORIC study is a prospective cohort study with a primary aim to assess the incidence     and independent predictors of reduced leaflet motion and valve thrombosis after TAVI     procedure using multimodality imaging strategy comprising cardiac CT, transesophageal     echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will     assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced     leaflet motion and/or thrombosis when compared with those with normal leaflet function. In     addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to     single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.      The primary outcome of the nested randomized trial will be the presence of reduced leaflet     motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of     ischemic changes in brain demonstrated by MRI.   "
35200|NCT02825043|"     The primary objective of this study is to look for a correlation between the use of HFNC in     the outpatient setting in patients with previous COPD exacerbation and the change in their     BCSS score. The hypothesis is that home use of HFNC will lead to a reduction in BCSS score by     1.3.   "
35201|NCT02825030|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35202|NCT02825017|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35112|NCT02826187|"     Total replacement of hip joint is one of the most important medical innovations of the     twentieth century. More than 100,000 hip replacements are being laid each year in France.      Improved fixation, reduced wear rates and reduced implant dislocation rates remain subjects     of continuous improvement.      Hip implants cemented and cementless are part of therapeutic arsenal of orthopedic surgeons     for joint replacement of the defective hip.      The anchor and friction torque are both essential to the survival of hip implants. Therefore     acetabular implants without cement with ceramic insert or polyethylene in a metalback or full     polyethylene coated with titanium grains without metalback are proposed, but they have their     own complications (Squeaking, fractures, recovery difficulties, difficult radiographic     analysis, high cost for ceramics, primary stability defects, instability of the instrument     set, Titanium residues in absence of metalback. An alternative to these implants may be an     acetabular component without cement with polyethylene insert with an end metalback to     increase both polyethylene thickness and size of the head in order to expect a low     complication rate with important longevity for a lower cost.      This study was conducted to ensure the safety and effectiveness of the acetabular implant     POLYMAX   "
35113|NCT02826174|"     Penetrating keratoplasty (PKP) is an open-sky surgery that fundamentally has not changed for     more than 100 years. Because conventional PKP is associated with the potential for the     development of devastating complications such as expulsive suprachoroidal hemorrhage and     endophthalmitis, we modified the technique to one that is a closed surgery under topical     anesthesia with the anterior chamber maintained to achieve favorable results. Topical     anesthesia is an attractive alternative to traditional injection local anesthesia since the     potentially serious complications associated with retrobulbar and peribulbar anesthesia can     be avoided. The closed PKP procedure with the stable anterior chamber essentially changes the     open nature of conventional PKP. The advantages, i.e., decreased surgical risks,     postoperative complications, and surgical difficulties, make PKP viable in most complicated     cases.   "
35114|NCT02826161|"     This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical     trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus     weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who     have disease progression following systemic treatment with a platinum-based combination     regimen in the metastatic setting, who have received treatment with an immune checkpoint     inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an     acceptable treatment option.   "
35115|NCT02826148|"     The diagnosis of developmental disorders in adults is still difficult. Indeed, in France,     there is not questionnaires to easily and accurately diagnose this disorder. Several     diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical     tool that aims to better identify autism spectrum disorders including mild forms in adult     people and help to diagnose of high-functioning autism . The objective of this study is to     perform a complete validation of this scale in the french version.   "
35116|NCT02826135|"     The purpose of this study is to evaluate predictability of an abdominal compression-induced     change of blood pressure for fluid responsiveness in children with single ventricle     (bidirectional cavopulmonary shunt and Fontan tract).   "
35117|NCT02826122|"     The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in     patients with morbid obesity attending a conservative lifestyle change program, 2)     investigate effects on cardiac function, cardiorespiratory Fitness, body composition, quality     of life and cardiovascular risk through the program, 3) investigate feasibility of     introducing two different activity monitors throughout the program, and 4) comparing     compliance to activity sensor market leader FitBit Application versus Mio Pai Application   "
35118|NCT02826109|"     Periodontal disease is a gum infection caused by plaque on teeth containing both bacteria and     calculus (hard) deposits. These need to be removed on a regular basis to maintain gum health     and to prevent teeth weakening. A routine cleaning procedure, scaling/root planing, is     accompanied with post-operative soft tissue tenderness and teeth sensitivity making oral     hygiene maintenance difficult during wound healing. The need for novel therapeutic     approaches, such as cyanoacrylate adhesives, has been identified. It has been hypothesized     that its application may provide comfort and assist patients with their daily oral self-care     procedures following teeth cleaning.   "
35119|NCT02826096|"     The study is to examine the therapeutic effect of a brief version of biofeedback therapy     (developed bu the research team) on panic disorder. It is a randomized controlled design. The     severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or     not) were measured before and after the six week duration. Besides, the severity of anxiety,     depressive, somatic symptoms, and physiological indexes were recorded.   "
35120|NCT02826083|"     Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural     polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative     stress notably with a decrease in certain markers of oxidative stress and on plasma lipid     parameters, the investigator proposes to study the effect of 6 months of treatment with XXS     in a controlled study against placebo in a population of persons presenting a lipid profile     at the upper limit of normal.   "
35121|NCT02826070|"     The purpose of this study is to demonstrate that long-term treatment (up to six years) with     telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and     fibrosis/cirrhosis.   "
35122|NCT02826057|"     This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24     hours or 48 hours of targeted temperature management.      The overall aim is to evaluate the importance of plasma complement protein concentrations in     patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48     hours of targeted temperature management.      The specific aim is to evaluate:        -  the concentration of plasma lectin pathway proteins the first, second and third day          after cardiac arrest        -  the relation between concentration of plasma lectin pathway proteins and mortality        -  if prolonged targeted temperature management influences the concentration of plasma          lectin pathway proteins      This study is a sub-study to the trial entitled: Time-differentiated targeted temperature     management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)      The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin,     M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.   "
35124|NCT02826031|"     This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for     which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In     the first 4 weeks (run-in period), the subjects will receive on-demand treatment with     Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die（QD）. After the run-in     period, the subjects, if their knee pain has not worsened to a level requiring surgical     treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via     intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR     75mg,quaque die（QD）, for 12 consecutive weeks on demand. The other group receiving DICL-SR     75mg alone,quaque die（QD）, for 12 consecutive weeks on demand. DICL-SR 75mg quaque die（QD）     may be administered to the subjects of both groups on demand as long as they have a knee     pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain     occurs again and requires treatment, oral administration of DICL-SR may be resumed. A subject     is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects.      A total of 8 visits have been scheduled for this study, including Visit 1/screening period     (Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3),     Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12).      A total of 300 subjects will participate in this study at 6 to 8 centers in China, and     patient enrollment is expected to take up to 12 months.   "
35125|NCT02826018|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV)     infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with     HBV.   "
35126|NCT02826005|"     Examination the ability to early diagnose HCC by combining three biomarkers technology     developed by WAKO, And their relevance to cirrhotic of patients with various backgrounds and     the Israeli population.      This blood test will serve as an additional diagnostic tool tools currently in use     (Ultrasound and AFP levels) to cirrhotic patients with high risk to develop hepatocellular     carcinoma.      Another group that will be examined for all three biomarkers will be patients which already     diagnosed with hepatocellular carcinoma, and have normal AFP level in order to examine the     correlation between the presence of tumor, the number of them and the tumor size and the     three biomarkers concentration in their blood   "
35127|NCT02825992|"     Post Market Clinical Follow-up Study designed to evaluate the incidence of device- and     procedure-related safety, efficacy, and efficiency (6 and 12 month outcomes) when using the     AcQMap™ as an imaging and mapping system for ablation of persistent atrial fibrillation (AF).   "
35128|NCT02825979|"     The EARLY-AF study is centered on an evaluation of the impact of the early invasive     management of Atrial Fibrillation. The primary goal of the study is to evaluate the clinical     effectiveness of an early invasive approach. Specifically, the investigators are aiming to     evaluate if PVI performed with the Arctic Front cryoballoon is superior to AAD as first-line     therapy in preventing atrial arrhythmia recurrences (arrhythmia related symptoms,     hospitalisations, and health care utilization).   "
35129|NCT02825966|"     A prospective, validation study to evaluate the data accuracy of heart sounds recorded by the     LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with the     heart sounds data recorded by an FDA-cleared device.   "
35130|NCT02825953|"     The present study was designed to evaluate, in premature babies with RDS breathing     spontaneously, the efficacy of combined treatment with nasal continuous positive airway     pressure (CPAP) and aerosolized surfactant. The first objective of investigators is to assess     the safety of surfactant nebulization in this clinical situation, and to ﬁnd out whether     treatment with aerosolized surfactant would reduce the need for mechanical ventilation. And     other aim suggest that aerosolized dates compared with dates of INSURE     (intubation-surfactant-extubation) and minimally invasive surfactant therapy (MIST) method.   "
35132|NCT02825927|"     The purpose of this study is to determine whether a specific rehabilitation program with oral     screen used in an elderly population with dysphagia can improve elderly's swallowing     capacity.   "
35133|NCT02825914|"     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent     colitis and using human in vitro inflammation models. Its use as a food ingredient has proven     safe and with no influence on dietary intake. In a pilot study the investigators found, that     orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine     in active distal ulcerative colitis.      The investigators wish to evaluate the effects in a larger group of patients with active     ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and     microbiome modulating properties.   "
35134|NCT02825901|"     The purpose of the trial is to evaluate the effect of Djulis-Buckwheat drink on     cardiovascular protection after ingesting for 8 weeks. In addition, the correlation between     the supplement and the cardiovascular disease-related gene expression is evaluated. The     results will be used for the application of functional products for cardiovascular     protection.      Ninety subjects (age 30~65) with Prehypertension or Hypertension stage 1 will be included and     randomly allocated into 3 groups: Placebo, Djulis-Buckwheat and Buckwheat. The subjects will     take sample (100 ml/day) for 8 weeks. Blood pressure will be measured on week 0, 1, 2, 4, 6     and 8. The blood biochemical parameters and gene expression analysis will be examined on week     2, 4, 6, 8 and 10 (the follow up).   "
35135|NCT02825888|"     Title of Research Program: Ultrasound Guided Axillary Brachial Plexus Block: Influence of     Obesity on Block Failure Rate, Performance Time and Incidence of Acute Complications- A     prospective observational cohort study      Background: Axillary brachial plexus (ABP) block is commonly performed as the primary     anesthetic technique to provide surgical anesthesia and postoperative analgesia for elbow,     forearm and hand surgery. Compared to general anesthesia, ABP blocks have been shown to     result in better pain relief, less nausea and vomiting, shortened length of hospital stay,     decreased side effects of opioids painkillers and better patient satisfaction. These     beneficial effects of ABP blocks are particularly useful for patients who are overweight or     obese as this cohort is at a higher risk of experiencing complications from general     anesthesia. Traditionally, nerve blocks have been described technically challenging in obese     patients. This may not be true now with availability of high-resolution ultrasonography (US).     US imaging also allows doctors the ability to visualize the needle live to allow for more     accurate needle placement. This allows local anesthetic to be placed more precisely resulting     in faster onset anesthesia, decreased local anesthetic drug dosages, reduced complications     and higher success rate. Ultrasound guidance has not been used for performing ABP block in     previous studies in obese patients.      Hypothesis: We hypothesize that the block failure rate is no worse in obese compared to     non-obese patients when US guidance is used to perform ABP blocks.      Specific Objectives: The primary objective of this study is to evaluate whether obese     patients receiving US guided ABP block as their primary anesthetic modality have a block     success rate (defined by a Composite Score ≥ 14 at 30 minutes) worse than their non-obese     peers. The secondary objective is to evaluate time parameters around ABP performance,     incidence of complications and patient satisfaction.      Methods: This study will be conducted as an observational quasi-experimental multicenter     trial at St. Joseph's Health Care (SJHC), London, ON and the Nova Scotia Health Authority     (NSHA) Halifax Infirmary (HI) site, Halifax NS. There will be 250 patients taking part in     this study. One hundred and fifty patients have already completed the study in Ontario. The     duration of the study at the Halifax Infirmary is 10 months. Healthy patients (aged 18-75     years) scheduled to undergo elbow/ forearm/ or hand surgery will be invited to volunteer in     this observational study. A study investigator or resident under direction supervision of a     study investigator will perform the ABP block. There is NO experimental drug or treatment in     this study. Patient demographics including age, sex, arm circumference, height, weight and     Body Mass Index will be recorded. Nerve blocks will be performed in a designated area near     operating rooms called the block room. US will be used for identification of the nerves     supplying the arm and an ABP block will be performed with a total volume of 30 mL of 0.5%     ropivacaine according to a standardized procedure. Measurements of sensory and motor blockage     will be recorded every 5 minutes for 30 minutes following the ABP block. Block success will     be measured and is defined as a score of ≥ 14 on the Composite Score (CS) within 30 minutes     of ABP block completion. According to routine care, all patients will receive a phone call     from the investigators 24-48 hours after surgery to inquire about complications. The study     follows non-inferiority design to show that the success rate in the obese group is not worse     than the non-obese when anesthetized. In non-inferiority trials, both intention to treat and     per-protocol analysis are recommended; both approaches should support non-inferiority The     student's t-test (unpaired, two tailed) will be used for comparison of the means of     continuous, normally distributed data or Mann-Whitney U test as appropriate. Categorical data     (success rate, complication rate) are to be analyzed using χ2 test or Fisher's exact test, as     appropriate. An interim analysis will not be conducted and set at 0.05 for significance and     95% confidence intervals.      Significance/ Importance: This study would provide anesthesiologists additional information     to inform their clinical decision-making when dealing with obese patients. To date there are     no publications or any registered trials exploring the success rates and technical aspects of     ABP blockade in obese patients using US guidance technology for block performance. Therefore,     this study is novel and timely for the patient groups.   "
35136|NCT02825875|"     In this study we aim to more precisely define the clinical utility of PSMA imaging across a     range of clinical indications in men with prostate cancer. To accomplish this, we will make     the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation     oncologists at Johns Hopkins and survey physicians as to the indication for ordering the     PET/CT and if a change in management occurred as the result of new information gained from     the scan. We believe these data will prove critical for planning future studies aimed at     evaluating the efficacy of this test for improving patient outcomes.   "
35203|NCT02825004|"     The purpose of this study is to prevent burnout and offer the hospital staff a space for     processing the emotional experiences.   "
35322|NCT02823457|"     This study implement a values-based motivational interviewing (VBMI) intervention to promote     treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30     Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C     virus (HCV) infection.   "
35139|NCT02825836|"     M7583 is an investigational drug that is being evaluated for the treatment of patients with     B-cell malignancies, which are cancers that form in B cells (cells that are part of the     immune system). This study has been designed to assess the use of the study drug in patients     with B-cell lymphomas who have tried and did not respond well (or the B-cell lymphoma came     back) to at least one but not more than three types of treatment for cancer. This is a Phase     I/II study, which means that it is looking at several dose levels of an investigational     medication in terms of its safety and how well it is tolerated in multiple doses. The final     selected dose will be tested for activity against the tumor in specific populations of     lymphoma (Mantle cell lymphoma and Diffuse Large B Cell Lymphoma)   "
35140|NCT02825823|"     The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can     be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a     ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance     but this has not been adequately studied. The purpose of this study is to determine whether     supplementing with an acute dose of ketone salts can alter fuel use during exercise and     improve exercise performance.   "
35141|NCT02825810|"     The aim of this study will be to determine the effectiveness of a physical therapy program     which is based on cervical motor control exercises in long-term breast cancer survivors in     order to improve their motor control and its possible impact on pain, mood state and quality     of life.   "
35142|NCT02825797|"     This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the     antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV)     broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in     HIV-infected individuals. This study is intended to support the development of the     combination of 3BNC117 and 10-1074 mAbs for use in the treatment of HIV-1 infection.   "
35143|NCT02825784|"     A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability,     and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd)     specially formulated to meet the unique nutritional needs of children from birth to 10 years     with chronic kidney disease (CKD)   "
35144|NCT02825771|"     Suicide is the second leading cause of death for American Indians and Alaska Natives aged     18-34 years. This study will evaluate Caring Contacts, a low-cost, sustainable intervention     for suicide prevention that sends caring text messages to people at risk. The investigators     will implement the intervention at four tribal sites, leveraging community strengths and     values to address this tragic health disparity in an underserved minority population.   "
35145|NCT02825758|"     A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element     supplement for children aged 11 years and over and adults on a ketogenic or restricted     therapeutic diet with regard to product tolerance, palatability and compliance.   "
35146|NCT02825745|"     In brief, this research is a prospective, feasibility study to evaluate the use of Betashot-     a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children     and adults diagnosed with epilepsy.      MCT is a type of dietary fat used in the ketogenic diet.   "
35147|NCT02825732|"     The investigators will investigate which patients' characteristics are associated with     caregivers burden and its evolution for outpatients visiting a memory clinic, in particular     how functional autonomy, behavioral and psychological symptoms as well as patients     comorbidities can influence caregiver burden.      The study will be conducted among outpatients with progressive cognitive complaint followed     in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers     experience a higher burden due to disease symptoms such as impairment of functional autonomy,     behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.   "
35148|NCT02825719|"     Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to     menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of     minimal invasive surgery is limited. There is also increase risk of intraoperative blood     transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM).     Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding,     fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking     evidence in terms of long term safety and efficacy, especially in Chinese population. The aim     of the present study is to evaluate the effect and safety on preoperative use of Ulipristal     on fibroid.   "
35149|NCT02825706|"     Although arthropathy is a serious problem in patients with hemophilia due to the associated     morbidity and incapacity, to the best of the investigators knowledge, no studies have looked     at the effect of educational physiotherapy for its clinical improvement.      This contribution presents the results of educational physiotherapy program applied for 15     weeks with home exercises - in patients with hemophilic arthropathy. After treatment,     experimental group showed improved a significant reduction of pain, and best quality of life     al illness behaviour. During treatment no patient showed elbow haemarthrosis, which     underlines the safety of this physiotherapy program.   "
35150|NCT02825693|"     This study aims to examine the health economic impact of adopting femtosecond laser     technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare     system, the National Health Service (NHS).   "
35151|NCT02825680|"     The overall goal of this project is to test whether the Learn. Engage. Act. Process (LEAP)     intervention helps teams within the Veterans Health Administration's local MOVE! group weight     management programs be more in line with guidance. Forty-eight sites will be randomized to     the LEAP intervention, which is a virtually delivered program that relies on the IHI Model of     Change, an online learning platform for clinician teams to share ideas and progress, an audit     and feedback process, and a barrier buster tool. The LEAP intervention will be compared to     active support that is provided to all VA MOVE! programs by the National Center for Health     Promotion and Disease Prevention (NCP). The investigators will compare whether participation     in LEAP results in engaging more Veterans in the MOVE! weight management program compared to     facilities not participating in LEAP. The investigators will also collect information to     understand what components of LEAP worked best and how to scale up so more teams can     participate in LEAP.   "
35379|NCT02822716|"     The objectives of this study are to study the safety and effect of IRE as a treatment for     inoperable hepatic and pancreatic malignancy.   "
35154|NCT02825641|"     The study is intended to compare expectant management and on presentation labor induction in     women with premature rupture of membranes.      The means of labor induction and cervical ripening are either oxytocin or dinoprostone.      Expectant management in this obstetrical state means waiting 24 hours from the onset of     rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone     depending on the patient`s obstetrical history and cervical condition.      The investigators` hypothesis is that active management will lead to a higher rate of vaginal     deliveries, a shorter interval between the time of rupture of membranes and the time of     delivery, a lower rate of cesarean sections and a better obstetric result for the mother and     the fetus/newborn.   "
35155|NCT02825628|"     This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre     study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC)     and skeletal metastases.      The primary objective is to evaluate the relative change from baseline in response markers     related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three     different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).   "
35156|NCT02825615|"     Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional     method (CM) were compared to find the better technique in general and in different     hemodynamic subsets of patients.      Method This is a prospective randomized, single center study of 100 patients. The details of     the primary cannulation technique, number of attempts, time taken, failure and cross-over     technique were recorded for three different hemodynamic subsets with Systolic blood pressure     <80 mm hg, 80-100 mm hg and > 100 mm hg.   "
35157|NCT02825602|"     The Vietnam Era Health Retrospective Observational Study (VE-HEROeS) is a national study on     the health and well-being of Vietnam Veterans, including Blue Water Navy Veterans, as well as     Veterans who served elsewhere during the Vietnam Era (1961-1975), and similarly aged U.S.     residents who never served in the military. The investigators will invite approximately     43,000 Vietnam and Vietnam Era Veterans, and approximately 11,000 members of the general U.S.     population to participate in VE-HEROeS. These individuals are scientifically selected to     participate; the study is not able to accept volunteers.      All participants in VE-HEROeS will be asked to fill out a questionnaire on their military     service, general health, age-related conditions, health care use, and the health experiences     of their children and grandchildren. A smaller group will be asked to provide the     investigators with access to some of their medical records. Topics of special focus for the     study include cognition, hepatitis C infection, and neurologic conditions.   "
35159|NCT02825576|"     The purpose of this study is to determine if the use of sugammadex (compared with     neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).   "
35160|NCT02825563|"     The purpose of this study is to further study the pharmacokinetic characteristics of     Anlotinib in Advanced Cancer Patients with High Fat Diet.   "
35161|NCT02825550|"     The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere     (T-ACE Beads) interventional therapy for liver cancer   "
35162|NCT02825537|"     The main objective of this study is to compare precisely, under standardized test conditions,     water balance changes in healthy subjects with or without the daytime use of compression     stocking.   "
35163|NCT02825524|"     The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency     ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia     or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.   "
35164|NCT02825511|"     Assessment of the concordance of the initial clinical and histological diagnosis and to     explore its prognostic impact in terms of risk of recurrence.   "
35165|NCT02825498|"     Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI)     dependent atrial flutter. We plan to perform a randomized prospective trial comparing the     efficacy of contact force (CF) guided CTI ablation against catheter ablation with the     operator blinded to contact force parameters.   "
35166|NCT02825485|"     It has previously been found that there is no correlation between degree of hydronephrosis     and presence of reflux; however this is oftentimes the criteria physicians use to obtain a     VCUG.   "
35180|NCT02825303|"     Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes,     several types of cancer and all-cause mortality. In combination with static and awkward     postures, the prevalence of musculoskeletal diseases can increase further. Although the     implementation of sit-to-stand or active workstations can help to reduce sitting time,     improve physical activity at work and promote health benefits, it might also lead to changes     in cognitive functions such as productivity The purpose of this study is to evaluate the     mid-term effect of a novel two desk sit-to-stand workplace on sitting time as well as     physiological and cognitive parameters for healthy people of working age in comparison to     their traditional workplace.   "
47110|NCT02668991|"     The purpose of this study is to evaluate the utility of and to clinically validate the Autism     Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD)     compared with other gold standard measures.   "
35182|NCT02825277|"     Introduction      Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy     complications related to chronic utero-placental hypoperfusion. Three-dimensional power     Doppler (3DPD) angiography has been used for the evaluation of utero-placental     vascularisation and three vascular indices have been calculated: the vascularisation index     (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints     hinder the clinical use of 3DPD as physical characteristics and machine settings may affect     3DPD indices, and so its clinical significance is not yet clear.      Objectives      The primary objective is to better understand the clinical significance of 3DPD indices by     evaluating the relationship between these indices and placental morphometry. Secondary     objectives are (i) to determine the impact of machine settings and physical characteristics     on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation patterns.      Methods and analysis      This is a prospective controlled study. We expect to include 112 women: 84 with normal     pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for     PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent     caesarean section, utero-placental 3DPD images with five different machine settings will be     acquired. Placentas will be collected and examined after surgery and stereological indices     (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and     VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler     and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between     3DPD indices and morphological indices will be assessed by Bland and Altman plots. The impact     of Doppler settings and maternal characteristics on 3DPD indices will be evaluated with a     multivariate linear regression model.   "
35167|NCT02825472|"     Rationale: Regular physical activity and aerobic exercise training are related to decreased     cardiovascular mortality in healthy individuals, as well as in individuals with     cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on     exercise training in adult patients with congenital heart disease.      Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a     six-month sports participation program in addition to usual care in symptomatic adult     patients with congenital heart disease improves exercise capacity and quality of life, and     lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.      Study design: International, multi-centre parallel randomized controlled trial.      Study population: Adult patients with congenital heart disease, who are in New York Heart     Association (NYHA) class II or III.      Intervention (if applicable): The intervention group receives a six-month individualized     exercise training program, the control group receives usual care.      Main study parameters/endpoints: The primary outcome is the change in peakVO2 between     patients in the sports participation group, and the control group. Secondary outcome measures     are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary     safety outcome is the composite of all hospitalizations, and all deaths during, or within     three hours after exercise. The secondary safety outcome is the composite of all exercise     related injuries for which medical attention is sought.   "
35168|NCT02825459|"     The purpose of this study is to see whether adults who use e-cigarettes every day experience     symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.   "
35169|NCT02825446|"     Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will     remove the spasm with macro and microcirculatory blood flow, which increases     revascularization patency of tibial arteries.   "
35170|NCT02825433|"     The ventilation (respiratory rate, tidal volume and end-tidal CO2) was monitored for patients     receiving procedural sedation during endoscopy procedures in order to observe what changes     commonly occur.   "
35171|NCT02825420|"     Non-interventional, multicenter, prospective, European study to describe the effectiveness of     trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to     SmPC regardless of previous use of an antiangiogenic drug   "
35172|NCT02825407|"     There are few data on elderly people concerning mechanisms involved in the in vivo release     and perception of aromatic compounds. Any knowledge on this point would be of great interest     to the scientific community. Concerning the dimensions of sensory perception and in-mouth     comfort, there is, to our knowledge, no methodology to describe them. These dimensions are     truly original and innovative, and investigating them will lead to the development of foods     adapted to elderly populations with chewing and salivation disorders.      The expected results are:        -  to obtain two groups of subjects with differences in chewing abilities and saliva          production        -  the characterization of flavour release profiles in elderly subjects with regard to oral          physiology (mastication and salivation) and saliva composition        -  a sensory profile describing in-mouth comfort when food is eaten   "
35173|NCT02825394|"     The investigators study aims to test the correlation between the Cascade Abrazo point-of-care     testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran     and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect     relevant levels of non-vitamin K antagonist oral anticoagulants (NOAC) in real-life patients.   "
35174|NCT02825381|"     The primary goal of the study is to evaluate the success rate of routine one-stage exchange     for treatment of chronically infected total hip arthroplasty performed at the investigators     institution, and to compare it to the current literature reporting success rate of selected     one-stage exchange procedure or two-stage procedure.      The secondary goal is to detect the potential prognostic factors and potential selection     criteria which may influence the success rate. The tested hypothesis is following: the     success rate of routine one-stage exchange is lower than that of selected one-stage or     two-stage procedure   "
35175|NCT02825368|"     The purpose of the study is to compare the immunological response of homeopathic vaccines to     placebo and to conventional vaccines in healthy young adults.   "
35176|NCT02825355|"     This study aims to evaluate the effect of SLN mapping compared to conventional radical PL on     the incidence and severity of lymphedema in women with early stage cervical and endometrial     cancer.   "
35177|NCT02825342|"     Non cardiac chest pain (NCCP) is defined as recurring, angina-like, retrosternal chest pain     of non cardiac origin. Annual prevalence of NCCP in the general population of the western     world ranges from 25-35%. Of those patients presenting to an emergency room with chest pain,     a cardiac etiology is ultimately found in only 11-39%. Several conditions are associated with     NCCP, with gastroesophageal reflux disease (GERD) being the most prevalent, constituting up     to 60% of cases. However, NCCP is considered a disorder of heterogenous nature and several     other conditions, apart of GERD, such as esophageal dysmotility and esophageal     hypersensitivity have been implicated.      Treatment of NCCP remains a real challenge due to the diverse underlying mechanisms     responsible for patients' symptoms. Given the fact that GERD is by far the most common     etiology, proton pump inhibitor (PPI) therapy has been tried extensively; however, after 6     weeks of treatment complete resolution of symptoms occurs in only 30% of patients, the     optimal duration of PPI administration is not known, while the best maintenance dose has     never been determined. Although the administration of selective serotonin reuptake inhibitors     (SSRIs) could theoretically benefit those patients with esophageal hypersensitivity, the     trials that have been published so far have included small number of patients and reported     conflicting results, while the co-administration of PPIs with SSRIs has not been evaluated so     far. Furthermore, data on treatment of patients with functional chest pain are lacking.   "
35178|NCT02825329|"     Open-label, non-controlled study of standard care plus the TORAYMYXIN PMX-20R (PMX cartridge)     in subjects who have endotoxemia and septic shock. This is a continued access study     subsequent to the EUPHRATES clinical trial NCT01046669.   "
35179|NCT02825316|"     This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on     therapy for induction of remission in adult patients with active Crohn's disease and to     evaluate its effects on clinical, inflammatory and microbial parameters.   "
35195|NCT02825108|"     The present study is designed as a pilot study with 50 patients in each group. Data     collection form will be filled by the researcher who does not know the type of intervention     in each group   "
35183|NCT02825264|"     STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting     anti-fibrotic properties. Release of this CE Marked implant has been limited to leading     Glaucoma Centers in Europe. Therefore this Clinical Experience Program is being initiated to     expand the surgical and clinical practice knowledge about the use of STARflo for reducing     intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world     population of patient.      This program is designed to be an international multicenter observational study Patient data     may be collected retrospectively and/or prospectively for up to 5 years after surgery.      The aim of this program is to document the patient's benefit following implantation of the     STARflo implant in a real-word patient population, to learn about surgical practices and to     collect data to support future cost-effectiveness analysis   "
35185|NCT02825238|"     The purpose of this research is to develop and test the feasibility of an exercise     intervention for persons with painful knee osteoarthritis involving the patella (kneecap).     Participants in the patellofemoral osteoarthritis (PFOA) group will be treated with a 6-week     supervised exercise program that targets strengthening the hip and trunk core muscles.     Painfree control participants will attend one session to gather biomechanical, strength, and     function data for use in comparison to the patellofemoral osteoarthritis group. Feasibility     outcomes include adherence to the treatment program, recruitment, and retention. It is     hypothesized that PFOA group participants will change score on a knee pain and function     questionnaire by the minimum clinically important difference score for positive improvement     at the end of the 6-week intervention program.   "
35186|NCT02825225|"     The main purpose is to compare the detection rate of 20-core versus 12-core prostate biopsy.     The secondary objective is to evaluate pain perception using a validated scale to compare the     analgesia provided by the two different local anesthesia schemes. Data will be prospectively     collected from patients who will undergo prostate biopsy in a single high volume urology     center. The patients will be randomized to two different biopsy samplings and two local     anesthesia schemes.   "
35187|NCT02825212|"     10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated     with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or     non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects     with cirrhosis).      The researchers anticipate that approximately 20% of subjects may have cirrhosis.   "
35188|NCT02825199|"     Objective: Assess the effect of caffeine in the following vestibular function tests: Cervical     Vestibular Evoked Potential (cVEMP), Ocular Vestibular Evoked Potential(oVEMP) and Caloric     Test.      Methods: Randomized, prospective triple-blind, placebo controlled clinical trial. All     participants underwent otoscopy, tympanometry, responded to the Profile of Mood State (POMS),     submitted to the cVEMP, oVEMP and caloric tests. After that they received placebo or caffeine     capsule (300mg) and repeated the procedures 45 minutes after.   "
35189|NCT02825186|"     The purpose of this study is to compare the efficacy and side effects of topical Loteprendol     etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.   "
35190|NCT02825173|"     The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for     the reinforcement and protection of gastrointestinal anastomosis.   "
35191|NCT02825160|"     This study is collecting post-marketing information on the safety and effectiveness of     Ventavis under the routine clinical practice for patients with PAH   "
35192|NCT02825147|"     Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in     Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients.     Asparaginase-based treatment has been demonstrated as promising response rate and survival     superiority. Stage-specified regimen may bring out exciting efficacy with good safety.   "
35193|NCT02825134|"     A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic     valve replacement in patients 75 years of age or younger suffering from severe aortic valve     stenosis.      Study hypothesis: The clinical outcome (composite endpoint of all-cause mortality, MI and     stroke) obtained within 1 year after TAVR is non-inferior to SAVR.   "
35212|NCT02824887|"     Compare the curative effects of electroacupuncture deep needling difference in efficacy of     the conservative treatment for lumbar five point therapy and routine western medicine, to     explore the efficacy and superiority, open a new way for the treatment of lumbar disc     herniation.Through a comparative analysis of the data on the efficacy of different TCM     Syndrome Types in the subgroup of patients with, to explore the effect of Electroacupuncture     of deep needling and five lumbar acupoint therapy is most suitable for the TCM syndrome     type.Through follow-up, patients in the two groups moment condition and the survival of the     state was evaluated, explore the effect of electroacupuncture deep needling the long-term     effects of five lumbar acupoint therapy for treatment of lumbar disc herniation and factors     that may influence the recurrence of symptoms.   "
35213|NCT02824874|"     The purpose of this study is to evaluate a pharmacokinetic drug interaction between     lobeglitazone and sitagliptin in healthy male volunteers.   "
35194|NCT02825121|"     Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by     stimulation of the ulnar nerve at the wrist.      However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort,     arterial catheterization), it is impossible to access the patient's wrists, delaying     monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient     extubation , leading in some cases to single injections lack of control of the reversal of     the patient.      To overcome these technical difficulties, a group nerve / muscle looks interesting and often     easily accessible to the anesthesiologist.      The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis     brevis muscle and allows quick access to monitoring the reversal before the end of the     intervention.      The primary outcome was to compare the speed of recovery from neuromuscular block flexor     hallux versus that of the adductor pollicis.      The secondary objective was to compare the speed of installation of deep neuromuscular block     flexor hallucis versus that of the adductor pollicis.      This is a prospective, exploratory, uncontrolled, single-center for routine care.      Are included all aged patients over 18 years, ASA I or II, without guardianship, having no     known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach,     predictable difficult intubation .   "
35204|NCT02824991|"     Background: One treatment of Muscle trigger points (MTrPs) is deep dry needling (DN) with the     purpose of obtaining local twitch responses (LTRs), which are highly effective in releasing     MTrPs. In DN procedures the mechanisms associated with LTRs and the LTR intensities required     for optimal clinical results are poorly understood, especially in relation to range of motion     after intervention. Therefore, evaluating the intensity of LTRs is relevant for implementing     DN in different clinical settings, such as in patients with muscular or neurological     dysfunctions. One way to assess muscle contractions and LTRs is through ultrasound video     analysis.      The aim of this report was to evaluate the reliability of semi-automatic LTR intensities     tracking during dry needling by assessing ultrasound signals with an image processing method,     in addition to evaluating the relationship between LTR intensities and muscle elasticity.      Method: Young males without signs or symptoms of musculoskeletal pain were included. Primary     outcome measure was the LTR intensities determined by percentage change of muscle thickness.     The secondary outcome measures were the muscle elasticity of medial gastrocnemius and     hamstring, previous and posterior DN in both lower limbs for each subject. Three LTRs,     detected by a physical therapist and ultrasound assessment, were induced by inserting a     filament needle into muscle latent trigger points in medial gastrocnemius. The intensities of     LTRs were measured by assessing ultrasound images using an optical flow method and through     comparisons with manual detection.   "
35205|NCT02824978|"     to evalute if therapeutic alliance is related to adherence in JIA   "
35206|NCT02824965|"     This will be a Phase Ib open-label trial of CAVATAK™ (CVA21) in combination with     Pembrolizumab for the treatment of patients with advanced NSCLC. The dose of Pembrolizumab     will be fixed at 200mg. Three cohorts (dose levels) of intravenously-delivered CVA21 will be     explored, using a standard 3+3 patient dose escalation design. The starting dose of CVA21     will be one log below the 1 x 10^9 TCID50 dose found to be safe when CVA21 was given alone in     an ongoing Phase I study (NCT02043665).   "
35207|NCT02824952|"     Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done     by PET-CT scan after 6 weeks.      In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding     patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of     response assessment at each time-point).   "
35208|NCT02824939|"     This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block     with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of     performance and safety when administered postoperatively in patients who undergo laparoscopic     nephrectomy.      To fulfill this purpose, three groups of patients each with 32 patients, will be formed.     Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group     will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion     of surgery. The third (Control group) will not receive any blocks. After shifting patients to     recovery all three groups will be put into intravenous patient controlled analgesia (PCA)     Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the     first postoperative 24 hours, ease of performance of individual blocks and associated adverse     events, adverse events associated with opioid use, patient recovery and satisfaction will be     noted.   "
35214|NCT02824861|"     This study evaluates a technology based intervention (physical activity tracker, text     messages, health coach, global positioning system enabled location based feedback on physical     activity) to support physical activity in cancer survivors after completing oncology     rehabilitation. In Phase 1 all participants received the full intervention. In phase II     participants are randomly assigned to receive the full intervention or a fitbit only.   "
35215|NCT02824848|"     Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes     the infant to tilt the head to one side and turn it to the other side. Infants with CMT also     show unequal use of both sides of the body for movement and play. In this randomized clinical     trial, researchers will compare two physical therapy (PT) treatment methods, passive     stretching and Perception-Action (P-A) Approach, in their effects on head position and use of     both sides of the body in infants with CMT. Behavior demonstrated during PT sessions by     infants in the two groups will be also compared. Thirty-six infants with CMT will be randomly     assigned to a passive stretching group or a P-A Approach group. The infants in both groups     will attend 5 weekly PT sessions, including the initial evaluation, 3 subsequent weekly     sessions, and a re-evaluation session. At visits 1 and 5, each infant's habitual head     position, the ability to turn the head to both sides, muscle strength on both sides of the     neck, motor development, and use of both sides of the body for movement and play will be     assessed. Each infant's behavior exhibited during therapy will be assessed at visits 2-4.     Results obtained from the two groups will be compared.      It is hypothesized that:        1. There will be significant gains achieved by both intervention groups between the initial          and final assessments on the following outcome measures:             1. Still photography             2. Arthrodial goniometry used to assess active head rotation to both sides             3. The Muscle Function Scale (MFS) used to assess neck muscle strength             4. The Alberta Infant Motor Scale (AIMS) used to assess motor development        2. There will be no significant difference between the groups on the above listed measures          after the intervention is completed.        3. The P-A Approach group will achieve greater gains than the passive stretching group          between the initial and final assessments on the Functional Symmetry Observation Scale          (FSOS) used to assess the use of both sides of the body for movement and play        4. The P-A Approach group will demonstrate higher Therapy Behavior Scale (TBS) scores than          the passive stretching group assigned based on participants' behavior demonstrated          during PT intervention sessions   "
35216|NCT02824835|"     The purpose of this study is to determine the effects of the plant hormones strigolactones,     on cell cultures of colonic polyps and colorectal cancer.   "
35217|NCT02824822|"     Epilepsy is a common condition which affects over 3 million people in the US. Patients with     uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which     is greatest in those under 40 years of age. The exact mechanisms and causes are not     understood but can be due to underlying conditions which affect the heart and brain, which     may lead to dangerous heart rhythms and death. Some of these conditions which affect heart     and brain have an identifiable genetic cause. This study aims to identify known genetic     causes of heart rhythm and sudden death related disorders in patients with epilepsy.   "
35218|NCT02824809|"     The Aims of the study are estimate the association between the severity of COPD and free     testosterone level and the prevalence of hypogonadism in adult men with stable COPD   "
35219|NCT02824796|"     The purpose of this study is to determine whether a new parent training protocol for children     with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art     Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment,     reducing the dropout rate and reducing the comorbidities.   "
35220|NCT02824783|"     The aim of the study is to investigate the quality of life and satisfaction of patient who     underwent colorectal surgery using an enhanced recovery protocol when back home.      In this retrospective study patients will be telephoned and asked to answer a questionnaire.   "
35221|NCT02824770|"     Endogenous melatonin is produced by the pineal gland at night under normal conditions and     regulates the sleep-wake cycle. Artificial light administered at night suppresses melatonin     production and sleep disturbances are accompanied by abnormal melatonin secretion such as     phase delay. Therefore, dramatic disturbances of endogenous rhythms in intensive care unit     patients have remarkable effects on melatonin production. In addition to its physiological     roles in regulating sleep patterns, melatonin has been demonstrated to provide     antiinflammatory effects in experimental models. Although some previous studies have     investigated the circadian pattern of melatonin in intensive care unit patients, the     investigators think that the present study is the first one that will assess the effects of     controlling noise and light on melatonin and inflammatory response after major abdominal     surgery.   "
35222|NCT02824757|"     This study is aimed at exploring the effects of glucocorticoids on glucose metabolism in     patients with interstitial lung disease. Patients with interstitial lung disease who is on     the medication of 15mg prednisolone and 7.5mg prednisolone conduct the continuous glucose     monitoring (CGM). The data attained from the CGM are used to define the glycemic     characteristics in patients using glucocorticoids and the difference of glucose features due     to different doses.   "
35223|NCT02824744|"     The purpose of the study is to evaluate prospectively the clinical benefits of 2 different     flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial     management of bronchiolitis in infants.      Design: Prospective, controlled, randomized, multi-center.      Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory     distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will     be randomized in two groups:HFNC 2l/min/kg or HFNC 3l/min/kg during 24 hours.      Conditions of measurements:      Primary endpoint: Proportion of failure in both arms during the first 24 hours.      Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or     respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4)     or apnea.      Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN     score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%,     transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2      Statistic: Intention to treat Analysis.      Expected number of patients: 135 per arm: 270 children.   "
35224|NCT02824731|"     This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with     different radiation modalities - protons or photons. Patients with different kinds of brain     tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is     that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after     proton compared to photon treatment.   "
35241|NCT02824510|"     The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG     evolution without insulin dose modification in patients with T1D under continuous     subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare     differences between these 2 groups; 2) to evaluate the impact of insulin dose modification     (bolus, basal, reduction or increase, based on SG evolution profile obtained after first     exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen,     and compare differences between these 2 groups.   "
35225|NCT02824718|"     Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce     sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic     activity. The most common cause of hypoparathyroidism is damage to or removal of the     parathyroid glands due to neck surgery for another condition. Occurrence of hypercalciuria     under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of     hypocalcemia.      Hypoparathyroidism can also be caused by an autoimmune process. In rare cases,     hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive,     autosomal dominant or X-linked recessive trait. The autosomal dominant hypocalcemia (ADH) is     mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR). As other     severe presentation of primary hypothyroidism, ADH is characterized by the increased risk to     develop hypercalciuria and nephrolithiasis. The purpose of the study is to compare two     therapeutic approaches in severe hypoparathyroidism in order to limit the risk of     nephrocalcinosis and renal failure when attempting to correct hypocalcemia: rhPTH(1-34) vs     association of active vitamin D and hydrochlorothiazide. The European Society of     Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic     hypoparathyroidism in adults. These guidelines suggest considering treatment with a thiazide     diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do     not stably and safely maintain their serum and urinary calcium in the target range.   "
35226|NCT02824705|"     Study investigators will develop a biomarker-based EN decision rule for post-operative     infants with CHD. Investigators lack objective data to inform decisions regarding provision     of EN, an area where subjective decision-making is currently the rule. Lack of standardized     practices for post-operative feeding lead to EN practice variation, which may harm these     infants with regard to septic morbidity and long-term neurocognitive outcomes. Study     investigators will address gaps in knowledge regarding the emerging role of the     gastrointestinal tract as a modulator of SIRS, sepsis, and organ dysfunction after CPB during     childhood. Finally, this proposal will inform the design of future studies to provide     individualized, safe EN support, targeted to intestinal EBF. This proposal presents several     innovations. First, the investigators will explore the gastrointestinal tract as a way to     improve post-operative outcomes after surgical repair of CHD in infants. Second, the     investigators will develop a feeding intolerance scale for use in future studies of EN     titration in infants with CHD. Third, this proposal prospectively evaluates biomarkers of     intestinal EBF in infants with CHD, a major advance in biomarker development in this field.   "
35227|NCT02824692|"     The purpose of this study is to determine whether a focused ultrasound examination for the     heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant     clinical findings in elderly patients before emergent surgery.   "
35346|NCT02823145|"     This is an international, multicenter, open-label, long-term safety study of ZX008 in     pediatric and young adult subjects with Dravet syndrome who have successfully completed 14     weeks of treatment in the core study (ZX008-1501 and ZX008-1502).   "
35347|NCT02823132|"     The aim of this study is to investigate levels of a protein, mannose binding lectin, in     patients with acute leukemia who develop or not an invasive fungal infection.   "
35228|NCT02824679|"     A case control study conducted on 120 women coming to Cairo University Maternity Hospital     .Patients who meet the inclusion criteria were asked to participate in the study and a verbal     consent was obtained from each patient. Patients will be divided into three equal groups (A,     B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected     intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in     bed. Vaginal examination will be conducted every two hours. The duration of the first stage     was calculated from the time of cervical dilatation of three to four centimeters in active     labour until a fully dilated cervix will be observed   "
35229|NCT02824666|"     This study involves evaluating the occupancy of ATI-9242 at steady state at three different     dose levels on D2 receptors in the brain using [18F] Fallypride PET in up to three cohorts of     subjects.   "
35230|NCT02824653|"     Graft versus host disease is a serious and often life-threatening complication in allogeneic     haematopoietic stem cell transplantation. Although corticosteroids are the first-choice of     treatment in these patients, but about 30-50% patients do not respond to it and develop     steroid-refractory GVHD. Mesenchymal stem cells (MSC) have emerged as a promising treatment     option in these patients. This phase-I/II clinical trial aims at establishing the safety and     clinical efficacy of allogenic ex-vivo cultured MSCs to treat steroid-refractory GVHD in a     Pakistani HSCT cohort.   "
35231|NCT02824640|"     People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other     groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been     developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive,     so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to prescribe     DAAs because they are concerned that PWID won't take their medication or that these patients     might become reinfected.      Several good models for treating PWID exist. One of them is to provide directly observed     treatment (DOT). Another model provides treatment to PWID with the support of patient     navigators (PN), public health workers who offer support and education to patients. Though     both the DOT and PN models have been successful, we still don't know which model works best.      In this study, the investigators will study both DOT and PN models for treating HCV in PWID.     The investigators' goal is to find out which model produces the best results and is preferred     by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight sites     around the country. Patients will be randomized into either the PN or the DOT groups.     Patients who end up in the PN group will get a biweekly blister pack of medication to take     home. Their PN will provide education and support. The investigators will find out whether     patients adhered to medication using an electronic adherence monitoring system. Patients who     are randomly assigned to the DOT group will take their medication in front of a staff member.   "
35242|NCT02824497|"     Respiratory distress is one of the first hospital grounds during the neonatal period. The     clinical presentation and severity vary by gestational age and cause. She reports to various     etiological factors as maternal, neonatal or sometimes entangled. The symptomatic management     has benefited from organizational progress (perinatal care) and techniques, including     antenatal steroids, the use of exogenous surfactant and non-invasive ventilation early, so     that the use of intubation is less frequent. The short-term evolution of patients with early     respiratory distress is based on gestational age, cause and initial management.   "
35243|NCT02824484|"     This study aims to investigate the efficacy of Guided Written Disclosure Protocol (GWDP) in     promoting post-traumatic growth through a process of meaning reconstruction in cancer     patients at the end of chemotherapy. Also, the intervention (GWDP) intends to reduce distress     symptoms (i.e. intrusive thoughts, avoidance, depression and anxiety).   "
35232|NCT02824627|"     Irritability and emotional dysregulation are recognized as serious aspects of psychopathology     seen in in pediatric psychiatric patients. While various behavioral as well as     psychopharmacological interventions have shown some efficacy in improving irritability and     emotional dysregulation, there are no data determining the neurobiological mechanism of     effect at the neural level. Previous studies have demonstrated that heightened amygdala     response to negative emotional stimuli is closely related to irritability and emotional     dysregulation in children and adolescents. Also, there are studies showing administration of     oxytocin can decrease the heightened amygdala response to negative emotional stimuli across     various psychiatric diagnoses. This study is a double-blind randomized trial of oxytocin for     irritability and emotional dysregulation in the pediatric population. Neuroimaging modalities     of fMRI and MEG are employed to probe the neuro-circuitry changes occurring as a result of     the oxytocin intervention, specifically including heightened amygdala response to negative     emotional stimuli and dysfunctional fronto-amygdala connectivity. The investigators will also     investigate the genetic sequence of the oxytocin receptor in the study participants and its     relationship with symptom profile and neural activity changes. Children and adolescents (age     10-18) with a diagnosis of disruptive mood and/or behavior disorders (including Attention     Deficit/Hyperactivity Disorder [ADHD], Oppositional Defiant Disorder [ODD], Conduct Disorder     [CD], and Disruptive Mood Dysregulation Disorder [DMDD]), and clinically significant levels     of irritability and emotional dysregulation as measured by the Affective Reactivity Index     Scale (score>/= 4).      2 weeks randomized, double-blind treatment with intranasal oxytocin (24 IU daily, or 12 IU     daily if the weight is < 40kg) with assessment of diagnosis, symptom profiles (the Affective     Reactivity Index [ARI], Inventory of Callous-Unemotional Trait [ICU], Behavior Assessment     System for Children, second version [BASC-2], and Clinical Global Impression [CGI]) and pre-     and post-oxytocin treatment neuroimaging (fMRI and MEG). The genetic sample will be obtained     via buccal mucosa sampling.      Participants may receive outpatient clinically indicated follow-up care in the UNMC     department of psychiatry or other local community agency as appropriate.   "
35233|NCT02824614|"     Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes     in the food industry and are also recommended to diabetic patients. Both substances are     already in use in the food industry and are freely available. Since the 1970s, beneficial     effects on oral health could be demonstrated as oral bacteria were influenced positively.     Animal studies showed an increase in gut Clostridium perfringens after xylitol intake;     certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on     the human gut microbiota are lacking so far. In this trial, investigators aim to examine     whether gut microbiota and glucose tolerance can be influenced by polyol intake in a     non-diabetic but obese cohort.   "
35274|NCT02824081|"     Suicide is a major health problem that causes annually a million death worlwide. In the     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an     individual's predisposition (personality, family history of SB…) and stressful conditions     (early life adversity).      Studies show that suicide ideations could favour inflammation and that depression is     associated with an elevated inflammation.      Recent evidences also suggest that inflammatory mediators play a critical role in SB.      The aim of the study is to evaluate the inflammatory markers rate on depressed patients with     or without personal history of SB.      In the second part of the study, the relations between the rates of inflammatory markers and     characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression     of 5HT2B receptor will be investigated.   "
35234|NCT02824601|"     This randomized clinical trial evaluated the effectiveness of supplemental photodynamic     therapy (PDT) in optimizing the removal of bacteria and endotoxins from primarily infected     root canals after one-visit and two-visit treatments.Twenty-four primarily infected root     canals with apical periodontitis were selected and randomly divided into one-visit (n=12) and     two-visit treatments (n=12). Chemo-mechanical preparation (CMP) was performed by using the     single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% Ethylenediamine     tetraacetic acid (EDTA). The photosensitizer agent (methylene blue 10 mg/mL) was applied to     root canals for 60 seconds and submitted to laser with a potency of 60 milliwatts (mW) and     energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment and after     14-day inter-appointment medication with Ca(OH)2 + saline solution (SSL) in the two-visit     treatment. Samples were collected before and after root canal procedures. Endotoxins were     quantified by chromogenic limulus amebocyte lysate assay. Culture techniques were used to     determine bacterial colony-forming unit counts.   "
35235|NCT02824588|"     The goal of this project is to investigate and improve executive control function in two     distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized     that there is a significant difference in the executive control function of patients with     neuropathic pain and FM pain. It is also hypothesized that all participants with poor     executive control functioning will report significant improvements in pain intensity,     functioning and cognitive complaints following cognitive training. The study tests and     influence the working memory concepts of inhibition, updating and flexibility through an     experimental, cross-over treatment design.      To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80     with FM) from the Departments of pain management and research at St Olav's University     Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine     whether or not executive control, processing speed and memory function differs in two     distinct populations of pain patients. Moreover, whether impairments are amended by     computerized training.   "
35236|NCT02824575|"     The purpose of this study is to determine the safety and tolerability of rebastinib when     combined with antitubulin therapy with paclitaxel or eribulin in patients with advanced     breast cancer.   "
35237|NCT02824562|"     Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine     has described chronic pain as a complex chronic disease and a national public health     crisis. The unique neurobiological basis and psychosocial context of chronic pain in     HIV-infected patients underscores the importance of developing and testing a behavioral     intervention specifically tailored to this population. This study will pilot test a     newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.   "
35238|NCT02824549|"     The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system     in children will be evaluated by questionnaires, pictures of the insertion site and     comparison of the glucose results with capillary blood glucose determinations.   "
35239|NCT02824536|"     This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly     neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074,     when given in combination, in human immunodeficiency virus (HIV)-uninfected individuals. This     study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs     for use as prophylaxis against HIV infection in healthy HIV-uninfected individuals at risk     for HIV infection.   "
35240|NCT02824523|"     The purpose of this research study is to learn new information about the underlying cause of     aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy.     AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to     aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on     individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for     clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and     subsequent treatment with daily high-dose oral aspirin is standard of care for patients with     AERD who do not respond adequately to steroids and have recurrent nasal polyposis or     symptomatic asthma. This study will involve four visits to Brigham and Women's Hospital and     will align closely with the standard of care for the treatment of AERD.   "
35256|NCT02824315|"     The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of     simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227),     when these drugs are co-administered in healthy Japanese participants.   "
35244|NCT02824471|"     'Sickle-shaped' anemia was first clinically described in the US in 1910, and the mutated     heritable sickle hemoglobin molecule was identified in 1949. The pathophysiology of SCD is a     consequence of abnormal polymerization of sickle hemoglobin (HbS) and its effects on red cell     membrane properties, shape, and density, and subsequent critical changes in inflammatory cell     and endothelial cell function. Our goal is to understand the impact of CMA abnormalities in     SCD, by interrogating a number of recognized interactions in a range of clinical phenotypes.      To date, correlative studies in SCD, by us and others, have range between clinical reports,     based on tests, interventions, and chart review of individuals or groups of individuals and,     at the other extreme, identification of functional gene polymorphisms based on population     studies. The investigators wish to augment these studies through a systematic examination of     cellular membrane properties and activation status. Of hematologic disorders, SCD may be     unusually susceptible to such an examination.   "
35245|NCT02824458|"     The main purpose of this study is to evaluate the safety and efficacy of Apatinib in     combination with Gefitinib as compared to placebo in combination with Gefitinib in     participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an     activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and     tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion     (Part A) before proceeding to the second portion of this study (Part B).   "
35275|NCT02824068|"     Long-term outcome in late-onset Pompe disease treated beyond 36 months (ATBIG-Pompe-Study), a     multicenter, multinational, longitudinal, non-interventional observational study in subjects,     at least 8 years old, diagnosed with late-onset Pompe disease retrospectively and     prospectively collects data to understand clinical progression in terms of muscle and     respiratory function, and clinical symptomology treated with alglucosidase alfa more than 36     months in 100 subjects.   "
35246|NCT02824445|"     After 13 years of war, PTSD has become pervasive in service members. Traditionally it is     evaluated by PTSD Checklist Military Version (PCL-M) and treated with cognitive processing     therapy, prolonged exposure therapy and medication management with limited success.     Repetitive Transcranial Magnetic Stimulation (TMS) has shown efficacy for improving     individual cognitive function in the past decades, both in healthy population and in patients     with depression. TMS has been approved by the FDA in treatment of major depressive disorder     and migraine headaches. Magnetic EEG guided Resonant Treatment (MeRT) is a form of     individualized TMS based on member's EEG/ECG input. Investigators propose to use MeRT to     treat veterans with war-related PTSD, a syndrome that includes depressive and anxious     symptoms; it is likely that MeRT (namely TMS) will be beneficial and comparable to or better     than the current FDA approved methods for treating PTSD.   "
35247|NCT02824432|"     The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on     vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients     with hyperlipidemia.   "
35248|NCT02824419|"     The goal of the current study is to evaluate the potential of the selected PET tracers to     detect sarcoidotic lesions in lungs. The tracers are already in clinical use for the     detection of certain inflammatory processes or malignant tumors, and their targets present     similarities with molecular mechanisms of sarcoidosis.   "
35249|NCT02824406|"     The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR)     measurements in adult patients with Sickle Cell Disease (SCD).      The primary objective is to assess whether there is a correlation between CVR and silent     cerebral infarcts (SCIs).   "
35250|NCT02824393|"     The aim of this study is to determine whether autologous adipose tissue derived Mesenchymal     Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.   "
35251|NCT02824380|"     An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/     Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.   "
35252|NCT02824367|"     Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer     of depression and / or anxiety. Also, clinicians reported that they exhibit specific     personality traits (e.g., rigidity and perfectionism).      To date, few studies used Cognitive Behavioural Therapies (CBT) in people with Parkinson's     disease showing promising results. Recently, perfectionism has received particular attention     because of it association with many emotional disorders. Thus, some psychometric tools have     been developed in order to evaluate different aspects of perfectionism. Yet, none of them has     been used in people with Parkinson's disease.      The objective of this study is to investigate whether there is a direct link between     Parkinson's disease and perfectionism by using psychometric tools from the CBT literature.     Identifying such link would allow to justify the use of CBT in people with Parkinson's     disease with the goal in mind to improve their care and quality of life.   "
35253|NCT02824354|"     Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of     alcohol consumption. It appears to be significantly more effective in the group of heavy     drinkers, while the mean alcohol consumption in studies conducted in cirrhotic patients is     greater than 120 g/day.      No data are available concerning nalmefene in alcohol-dependent patients with alcoholic     cirrhosis. However, nalmefene could represent an attractive alternative to reduce heavy     drinking in patients with alcoholic cirrhosis, with potential improvement of liver function.     No comparator is available for nalmefene, as all other molecules require abstinence prior to     starting treatment.   "
35254|NCT02824341|"     Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD),     a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and     brainstem.      Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic     drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic     pathways which belong to the so-called reward system.      A strong link was found between these two disorders and therefore the investigators believe     that RBD is associated with impaired reward system.      The main objective of this study is to evaluate differences in brain activation between PD     patients with and without RBD.      The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the     reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD,     explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.   "
35255|NCT02824328|"     The investigators propose to collect biologic samples (i.e. tumor tissue, ascites, and/or     blood), from patients undergoing standard of care therapy for a gynecologic malignancy. To     detect changes in the immune response following chemotherapy, collection of biologic samples     will occur at baseline and at the time of surgery following chemotherapy.   "
35257|NCT02824302|"     Labor pain is complex to understand and challenging to define because of the interaction of     multiple maternal and fetal factors. Poorly controlled acute post-procedural pain may result     in harmful physiological and psychological consequences for both mother and baby. It is     therefore important to understand the prelabor factors that may affect the labour pain to     facilitate the intrapartum pain management. The goal of this prospective observational study     is to verify if expectations regarding pain experience translate to actual pain outcomes for     women who are undergoing induction of labor.   "
35258|NCT02824289|"     A sample of local government organizations are recruited to a group-randomized     pretest-posttest controlled trial evaluating the effect of a campaign to promote workplace     policy and education on sun protection for outdoor workers. Primary outcome is adoption of     formal policies and secondary outcomes are implementation of policy and sun protection     practices by outdoor workers.   "
35276|NCT02824055|"     This is a multicenter, randomized, double-blind, placebo-controlled, three period crossover     study to evaluate the effects of RO5545965 on the functioning of key brain circuitry involved     in negative symptoms using functional magnetic resonance imaging (fMRI) and reward-based     learning in stable participants with mild to moderate negative symptoms of schizophrenia     treated with antipsychotics. Participants will be randomized to one of six different     sequences during which each participant will receive three 3-week treatment courses with     RO5545965 5 milligrams (mg), RO5545965 15 mg and placebo. Each treatment period will be     separated by a washout period of 14 days. Total duration of study will be approximately 17     weeks.   "
35259|NCT02824276|"     Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of     disability and reduced quality of life. The prescription of opioids for chronic low back pain     (CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in     their recent Guideline (released in March 2016): Opioids are commonly prescribed for pain.     An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or     pain-related diagnoses (including acute and chronic pain) receive an opioid prescription.     Interestingly, patients scoring very high on measures of psychological distress tend to be     systematically excluded from RCTs, even though this subgroup of patients is highly prevalent     within the chronic pain population.      This study will provide key information on individual differences in the outcomes of opioid     treatment, and its findings should facilitate more effective tailoring of analgesic regimens     to individual patient characteristic.   "
35260|NCT02824263|"     Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown     mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid     metabolism during sleep, which over time could lead to diabetes and cardiovascular disease.     This study examines metabolic changes during sleep in patients with obstructive sleep apnea.     Patients accustomed to CPAP therapy are enrolled to undergo sleep studies, either on CPAP     therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained     so that metabolic function can be compared between sleep apnea and CPAP nights.   "
35261|NCT02824250|"     The primary aim of this study is to conduct a randomized controlled feasibility trial of MBSR     for patients with moderate-to- severe migraine headache.   "
35262|NCT02824237|"     Background:      The increasing effect of environmental, occupational and climate change poses serious global     threat for public health. More than half of the world's population, including around 85%     people in Bangladesh, are exposed to household air pollutants (HAP). Environmental     consequences of climate change are among the highest. Little evidence is available on the     effects HAP on cardiopulmonary outcomes in low-income populations. Same is true for     occupational health and climate change. The investigators will evaluate the effects of HAP on     cardio-pulmonary and markers of immune function among non-smoking individuals. The     investigators will also conduct two pilot studies to explore health effects associated with     working in the garments industry and that of temperature due to climate changes.      Hypothesis:        1. Preclinical measures of cardiovascular diseases and pulmonary function are associated          with exposure level of house hold air pollution (HAP) (assessed through PM2.5, CO and BC          concentrations)        2. Stable biomarkers of immune function and inflammation are associated with exposure level          of HAP.        3. Use of improved cook stove reduces exposure to HAP and thereby improve pre-clinical and          molecular measures of cardio-pulmonary and immune functions.      Methods: The investigators will conduct a cross sectional study to assess the associations of     HAP with preclinical makers of CVD among 600 non-smoking participants aged 25 to 65 years.     Biomass exposure will be assessed for PM2.5, carbon Monoxide (CO) and black carbon (BC) by     collecting personal air samples for 24-hour. Blood sample will be utilized from a subset of     200 adult participants and 60 children aged 3-5 years for assessing immune markers. The study     will be conducted in icddr,b and URB study site at Matlab and Araihazar respectively.      After the cross sectional assessment, the investigators will conduct a pre-post intervention     study to evaluate effectiveness of improved stoves in a subset of 200 homes. The     investigators will measure the aforementioned markers after two years of cook stove     installation. Finally, as pilot studies, health outcomes due to climate change (temperature     change) and occupation (garment industry work) will be explored.      Outcome measures:      HAP will be assessed through PM2.5, CO and BC concentrations. Pulmonary function will be     assessed through FEV1, FVC and FEV1/FVC. Preclinical makers of CVD will include RH-PAT, FMD,     IMT, BAD, EKG and PFT. Markers of Immune function - proliferation of macrophage, dendritic     cells (DC), neutrophils and T-cell, as well as macrophage derived cytokines (a panel of 17 or     27 cytokines) in peripheral blood mononuclear cells (PBMC)   "
35263|NCT02824224|"     This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in     new users of the 52mg levonorgestrel-releasing intrauterine device. Half of participants will     receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of     participants will receive a course of placebo.   "
35264|NCT02824211|"     Purpose: To investigate the feasibility of a new oxygen delivery device, the Right Dose     System (RDS). It delivers individualized boluses of oxygen during rest and exertion to     maintain acceptable oxygen saturations.      The procedures include: Enrollment of 10 patients, who are randomized to either exercise with     their oxygen prescription followed by exercise with the RDS, or exercise with the RDS     followed by exercise on their oxygen prescription. Randomization will occur on a 1:1 basis.     Each set of exercise will be separated by a 30 minute recovery session. Subjects will be     adults who are on supplemental oxygen and are able to exercise on a treadmill. Subjects will     be above 18 years of age. Subject participation will last approximately 1 month. Subjects     will be recruited from the Loma Linda pulmonary clinic and the pulmonary rehabilitation     program. Consent will take place in the pulmonary clinic, pulmonary function lab or pulmonary     rehabilitation by trained study physicians. If Multi-center: N/A (single center) If Single     center or investigator-initiated: 10 subjects will participate in the study.   "
35265|NCT02824198|"     The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine     dose administered 5 years after the completion of a 3-dose vaccination schedule.      Primary Objective:        -  To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GTMR) of          a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in          subjects from CYD 28 trial (subjects from Group 1 only).      Secondary Objectives:        -  If the primary objective of non-inferiority is achieved: To demonstrate the superiority,          in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue          vaccine injection in subjects from CYD28 trial (subjects from Group 1 only).        -  To describe the immune responses elicited by the CYD dengue vaccine booster or placebo          injection in subjects who received three doses of the CYD dengue vaccine in the CYD28          trial in all subjects.        -  To describe the neutralizing Abs levels of each dengue serotype post-dose 3 (CYD28          subjects) and immediately prior to booster or placebo injection in all subjects.        -  To describe the neutralizing Ab persistence 6 months, 1 year and 2 years post booster or          placebo injection in all study subjects.        -  To evaluate the safety of booster vaccination with CYD dengue vaccine in all study          subjects.   "
35277|NCT02824042|"     Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of     anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by     concomitant administration of itraconazole in subjects with mesothelin-expressing advanced     solid cancers   "
35278|NCT02824029|"     This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in     the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial     treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth, by altering the environment around the tumor or by affecting the     immune system.   "
35348|NCT02823119|"     The aim of this study is to evaluate the effect of hysteroscope diameter on the pain     experienced by nulliparous patients undergoing diagnostic office hysteroscopy.   "
35266|NCT02824185|"     Hepatocellular carcinoma (HCC) is the fifth most common cancer in terms of incidence and the     second in terms of mortality. At an early stage, which is based on a low number and size of     liver nodules and the absence of extra-hepatic locations (Milan criteria), a curative     treatment can be performed, i.e. liver transplantation, surgical resection, or     thermo-ablation. These treatments can lead to severe complications, so patients benefiting     from them must be carefully selected. The correct identification of all HCC lesions at the     time of the therapeutic decision is crucial. MRI is the reference examination for diagnosis     but its field of exploration is limited to the upper abdominal area and its sensitivity     decreases for nodules of less than two centimetres. Such lesions could actually be HCC that     will cause early post-operative progression.      Positron Emission Tomography (PET; functional imaging) with fluorodeoxyglucose can provide     prognostic information but impacts initial staging in less than 5% of cases. However, PET     with fluorocholine (FCH), available in France since 2010, could detect intra- and     extra-hepatic HCC lesions not identified by conventional imaging, potentially impacting     patient management (e.g. 52% of patients in a small case study).      FCH-PET/MRI could therefore be the ideal examination for the initial staging of HCC,     combining in a single multimodality investigation the reference morphological imaging     technique and an efficient functional one. The hypothesis of this study is that FCH-PET/MRI     is able to detect, in patients eligible for curative treatment, additional preoperative     intra- and extra-hepatic early or metastatic HCC unseen or equivocal with conventional     imaging (CT and MRI) and responsible for recurrence or disease progression at 6 months.   "
35267|NCT02824172|"     The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose     accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee     and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually     considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases     there is persistent residual pain in adulthood.      The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who     continued his sports without restriction.      The possible consequences are numerous including the presence of a free bone fragment at the     insertion of the tendon originally described by Osgood the establishment of a genu     recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying     sport.      The main two treatments are complete rest from sport activity or cast immobilization.      The main objective is to compare these two technics according to the proportion of full     sporting recovering at 12 months   "
35268|NCT02824159|"     Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic     Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and     Mantle cell lymphoma (MCL) for idelalisib.      Clinical trials for ibrutinib and idelalisib were performed with a small number of patients     (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of     these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this     study is to determine the association between clinically significant side effects occurrence     during the first year of treatment and plasma mean concentration of the steady state of     ibrutinib or idelalisib at 1 month.   "
35269|NCT02824146|"     Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of     pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts     with anesthesia induction but can persist for hours or even days after surgery. Such     anesthesia-related atelectasis has a number of negative clinical consequences such as the     impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for     ventilator-associated lung injury. The adjustment of ventilator settings for preventing the     occurrence of atelectasis and for reducing pulmonary complications remains controversial.      Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children,     including atelectasis of different origins. LUS has demonstrated its high sensitivity and     specificity for diagnosing anesthesia-induced atelectasis in children.   "
35270|NCT02824133|"     The investigators will look for the presence of the fusion gene in all patients operated on     for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the latter     being sought in both routine and anomalies never co-existing.      The hypothesis is that the rate of progression-free survival in grade IV gliomas and III     without IDH1 mutation, with the usual chemotherapy, only 15% at 6 months (ie, 85% of patients     relapse before 6 months of treatment), must be with this new treatment 35% (primary     endpoint).      The main objective is the evaluation of disease-free survival at 6 months.   "
35271|NCT02824120|"     Laugh is more than visual and vocal behave, is always followed by a series of physiological     changes, including contractions of musculoskeletal system, increase of cardiac frequency by     catecholamine release and hyperventilation that promoves the increase of maximum breathing     and oxygen saturation. Laugh therapy may be an alternative therapy, simple, and improve the     quality of life of individuals can influence physiological and biochemical parameters of the     human body.   "
35272|NCT02824107|"     The aim of this study is to identify groups of subjects at risk of recurrence in secondary     prevention based on Psychosocial Factors.      The aim is also to propose novel levers to reduce health inequalities in this population so     as to develop new prevention strategies for neuro- and cardio-vascular health This study is     based on data from questionnaires (Quality of life at work, perceived stress, perceived     disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking,     obesity, sedentarity).      Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study     because of blood sample   "
35273|NCT02824094|"     Primary objective of this study is to allow access and evaluate the safety of crizotinib for     patients in Japan with advanced NSCLC harboring a translocation or inversion involving the     ROS1 oncogene.   "
35293|NCT02823834|"     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to     evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in     the European Union (EU). These types of studies are required by regulatory authorities for     all THA devices that do not have medium to long-term clinical evidence available at the time     of gaining approval to market in the EU. This study has been designed in accordance with the     medial device directives (MEDDEV) 2.12/2 rev 2.   "
47534|NCT02663427|"     The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined     with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening     in community of Wuxi City.   "
35279|NCT02824016|"     Prospective, multicentric, comparative, non randomised, in current care.      Primary objective:        -  To evaluate the incidence of hypothyroidism in breast cancer patients treated by          radiotherapy including the supra-clavicular area over a period of 5 years (60 months).      Secondary objectives :        -  To calculate the dose of irradiation received by thyroid gland during the treatment.        -  To compare the rate of incidence of hypothyroidism in women who received a          supra-clavicular irradiation (group 1)and in those who did not (group 2).        -  To estimate and compare the rate of incidence of chronic thyroid lesions in the 2          groups.        -  To look for predictive factors of hypothyroidism de novo in group 1 women particularly          regarding the dose-volume parameters.        -  To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.   "
35280|NCT02824003|"     The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic     Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.   "
35281|NCT02823990|"     This phase II trial studies how well TG4010 and nivolumab work in previously treated patients     with non-small cell lung cancer. Vaccines that are made from a gene-modified virus, such as     TG4010, may help the body build an effective immune response to kill tumor cells. Monoclonal     antibodies, such as nivolumab, interfere with the ability of tumor cells to grow and spread.     Giving TG4010 and nivolumab together may work better in previously treated patients with     non-small cell lung cancer.   "
35282|NCT02823977|"     This study is designed to evaluate the addition of ketamine to dexmedetomidine as adjunctive     therapies of severe alcohol withdrawal in medical ICU patients. Specifically, this study will     assess whether the combination of ketamine and dexmedetomidine reduces the doses of     conventional agents used for alcohol withdrawal while maintaining patient comfort and safety     and will explore if the combination alters the expression of catecholamines in the serum over     time.   "
35283|NCT02823964|"     Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and     amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be     formulated without enteric coating for administration either as a capsule or as a dosing     solution dissolved in water or juice.   "
35284|NCT02823951|"     The purpose of this study is to evaluate the proportion of patients who demonstrate no     medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple     sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based     on real-world data.   "
35291|NCT02823860|"     To access to good quality biological samples is a prerequisite for high level translational     research. The BIG-RENAPE study has been established by the French hyperthermic     intraperitoneal chemotherapy centers involved in the management of peritoneal surface     malignancies.      The main BIG-RENAPE study aim is to create a large multicentric and prospective repository     for biological and tissue samples, which will provide a source of materials for a wide array     of health related research studies - BIG-RENAPE Biobank-based research: i) validating known     and promising biomarkers; ii) identifying new predictive and prognostic factors; iii)     evaluating the impact of current health care strategies; iv) standardizing diagnostic and     therapeutic management through guidelines; v) developing new drugs.      The BIG-RENAPE Biobank is certified according to NFS 96-900 as a service of processing,     storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue     (formalin-fixed-paraffin-embedded) samples. Biospecimens are collected at each stage of     diagnostic and therapeutic care. The patient and his derivates are anonymized and registered     in a national web database reporting disease status, treatments, surgical procedures,     pathological diagnosis, quality of life's assessment and long term follow-up. All     participants have given their informed consent before any sample. The BIG-RENAPE study was     approved by the local Ethical Committee, based on the assessed compliance to French     regulatory rules.   "
35285|NCT02823938|"     In France, a person consumes an average of 48 boxes of medicines per year (ANSM 2012). Among     these substances, some, not prescribed in an indication related to cognitive function,     however, will influence thereon.      Several drug candidates with potential preventive effects have already been explored with     little success (statins, antihypertensives, NSAIDs, aspirin, steroid hormones). Other studies     have suggested the existence of deleterious cognitive effects of certain substances     (benzodiazepines, anticholinergics, anti-cancer chemotherapy). However, only the effects of a     limited number of drugs were analyzed, and most drugs have not been specific study in     epidemiology.      The study of this research theme has often been restricted by the limited size of the cohort     of staff, not allowing the study of sometimes rare drug exposures, and poverty of the     information collected on drug exposures. Thus, most studies focuses on families of molecules     among the most prescribed. In addition, we now know that the pathophysiological process     underlying Alzheimer's disease (representing 2/3 of dementia), actually begins more than 10     years before the diagnosis of dementia. It is therefore essential to have a setback of     several years between drug exposure and diagnosis of dementia to assess their role in the     genesis and evolution of the disease.      The Generalist Sample Beneficiaries (EGB) is a database containing data of health insurance     and those of medicalization program of information systems (PMSI) for a sample of 550 000     subjects enrolled in the general scheme of the insurance since 2004 and followed for a period     of 20 years.   "
35286|NCT02823925|"     Multicentric osteolysis, nodulosis and arthropathy (MONA) spectrum disorder is a rare     inherited progressive skeletal disorder caused by mutations in the matrix metalloproteinase 2     (MMP2) gene. Treatment options are limited. The investigators reviewed the outcome of     patients affected with MONA and treated with intravenous bisphosphonates in the clinical     Center.   "
35304|NCT02823691|"     This is a Pilot, One-arm, Open-label, Prospective Study to evaluate Safety of Lanreotide 120     mg ATG in combination with Metformin in patients with advanced progressive GI or lung     carcinoids.      The patient population will include patients with a histologically documented diagnosis of     Well differentiated NET, G1-G2 according to the last WHO Classification criteria for GI and     lung NET carcinoids.   "
35305|NCT02823678|"     This study will enroll 100 patients scheduled to undergo a pancreatectomy.      The primary objective is to develop a scoring system using pancreatic volume measured by CT     scan and intraoperative measurements of the pancreas parenchyma to predict the onset of     diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with     pre-existing diabetes to see if their diabetes worsens or improves.   "
35287|NCT02823912|"     The increased mortality from cardiovascular disease has a significant impact on the     population, and the prevalence of these diseases it become one of the major problems, since     it is the leading cause of mortality and 1 in 3 Mexicans suffer from cardiovascular disease     according ENSANUT; the above is attributed to the increase of diseases associated with an     inflammatory process accelerated as obesity, dyslipidemia, hypertension (SAH) and diabetes     mellitus (DM).      The cholesterol is a major risk factor in the development of cardiovascular disease, and in     turn increases the chances of death; however, the treatment of choice is based on changes in     lifestyle, which for most people are difficult to maintain long-term. As for the drug therapy     treated with drugs many people do not achieve their therapeutic goals, and therefore the     inflammatory condition that underlies this disease remains.      Recent studies have focused on the possible role of capsaicin in the inflammatory state     through the agonistic effect it has on TRPV1. It has demonstrated the antiinflammatory     activity of capsaicin to enhance inflammation by free fatty acids (FFA) and reducing the     expression of certain genes involved in this process induced. Capsaicin is a natural choice     and well tolerated with few side effects limited to the gastrointestinal tract such as     dyspepsia and intestinal irregularity, for the above is of interest to evaluate the effect of     capsaicin on the profile of inflammatory cytokines in individuals with dyslipidemia.   "
35288|NCT02823899|"     Cholera, a rapidly dehydrating watery diarrheal disease transmitted through water or food     contaminated with the bacterium, Vibrio cholerae, is a major cause of morbidity and mortality     in low income countries like Bangladesh. In our country, Cholera disease burden consists of     both cholera outbreaks and endemic cholera comprising at least 300,000 severe cases and 1.2     million infections each year. To combat this situation, Vaccination against cholera has been     proved effective both in endemic and epidemic settings. But, the WHO recommended Dukoral and     Prequalified Shanchol are quite expensive for our country perspective. Therefore, locally     manufactured OCV can improve the cost effectiveness and make it affordable for all. The     hypothesis of this proposal is that Locally produced orally administered whole cell     inactivated HL-OCV test formulations A and B are safe and immunogenic in adults and children     in Bangladesh as compared to ShancholTM. The results of the study will allow us to understand     the safety and immunogenicity outcome of the HL-OCV compared to Shanchol vaccine. The total     sample size will be 840 healthy participants. 840 healthy participants (360 adults, 240     Children and Adolescent and 240 young children) of 18-45 years, 5- less than 18 years and 1     year to less than 5 years will be enrolled in the study. Children whose parents/guardians     give voluntary consent will be enrolled in the study. The investigators will provide 2 dose     of vaccine for three groups in 14 days interval. Test formulations will be locally     manufactured and the comparator group will get Shanchol. The Investigators propose to collect     three blood samples (Day 0, 14 and 28).   "
35289|NCT02823886|"     An intense inflammatory reaction is triggered by the ischemic injury during myocardial     infarction. The inflammatory processes involved are complex and haven't been explored in     detail in human patients. This inflammatory response can increase myocardial damage following     reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac     death).      Cardiac MRI can assess the size of myocardial infarction and many other parameters associated     with myocardial injury: edema, hemorrhage, micro-vascular obstruction.      (However the association between biomarkers of inflammation and these imaging parameters is     not known).      There is very little data correlating imaging markers of myocardial injury to the biokinetics     of inflammation biomarkers.      In this study, the aim is to assess the relationship between the kinetics of specific     inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis     Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2),     neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20     acute mycardial infarction (AMI) patients.   "
35290|NCT02823873|"     The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff     in pregnant and postpartum women who have either normal blood pressure or high blood     pressure.   "
35292|NCT02823847|"     The goal of this clinical research study is to learn how a new method for performing oral     (mouth) exams can help doctors check for suspicious lesions (called premalignant and     malignant oral lesions [PMOL]) in the mouth of HIV-infected smokers.   "
35294|NCT02823821|"     This global study will assess the effect of randomising dialysis sites to one of two default     dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major     cardiovascular events and death in patients receiving maintenance haemodialysis.   "
35295|NCT02823808|"     All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group     (control) after intensive COAD treatment based on identical protocol.        -  All subject will be managed with once daily, fixed dose, single tablet treatment based          on the study protocol, and followed-up for 104 weeks.        -  Any group of subjects who fail to reach glycemic target with single tablet treatment,          subject will be treated with rescue medication and stopped regular observation.   "
35296|NCT02823795|"     This study evaluates if motivational interviewing sessions aiming to motivate recently     discharged patients with either chronic obstructive pulmonary disease or congestive heart     failure to be active in post-discharge self-management can reduce re-hospitalization rates.   "
35306|NCT02823665|"     The purpose of this study is learn the effect of gastric bypass surgery and sleeve     gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after     eating.   "
35307|NCT02823652|"     This research trial studies how well pre-test genetic education and remote genetic counseling     works in communicating tumor profiling results to patients with advanced cancer. Web-based     genetic education before receiving tumor profiling results and remote genetic counseling for     patients with potential germline mutations may increase genetic knowledge and reduce distress     for patients with advanced cancer.   "
35350|NCT02823093|"     The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of     thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic     calcifications development. This is a biomedical research without health product, transversal     and monocentric study which compares the aortic calcifications levels of two populations :     one treated by VKA and the other which has never been treated by VKA.   "
35297|NCT02823782|"     Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for     consultation, among the most frequent, in general or pediatric medicine. Among the different     clinical forms of instability, ADHD appears to be an especially disabling condition for the     development of the child, both in psychomotor, cognitive, emotional and relational aspects.     Further, a significant link between ADHD children and some children with High Potential (HP)     is observed. HP children show overall ahead cognitive developments compared to children with     the same age. In these children, as well as in children with ADHD, an attention     vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits     that significantly contrasted with some of their cognitive skills. Regarding the HP, the     hypothesis is that children with significantly heterogeneous results (Complex) to the     Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential     diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more     homogeneous (Laminar).      The goal of this work was to study a population of 80 children aged from 8 to 12 years (20     subjects per group) to evaluate the functional and structural brain development by:        -  Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations,          involving attention, working memory and semantic processing, and emotional stimulations,        -  fMRI acquisitions at rest (without activation),        -  diffusion tensor magnetic resonance imaging (DTI) acquisitions,        -  3D anatomic acquisitions. Identification of developmental differences in certain          cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or          functional networks preferentially used by one or other of these groups, will help to          better understand this disease, and to improve the differential diagnosis in order to          implement a more appropriate and personalized management of the patients via new          therapeutic strategies.   "
35298|NCT02823769|"     Despite the advances in adhesive restorative techniques and materials, dental caries still     remains a critical concern even today. In addition, recurrent caries related to microleakage     is a common mode of failure of directly placed resin composite restorations. Resin composites     are particularly susceptible to recurrent caries due to polymerization contraction and also     imperfect adhesion of restorative to tooth tissue. Thus, strong durable bond between adhesive     restoratives and tooth tissue and increasing the resistance of teeth to acid by encouraging     the development of remineralization are essential to withstand secondary caries. Fluoride has     been documented as a major contributing factor for the decline in the incidence of dental     caries and also it has been accepted as an agent in the prevention of caries. Giomers are a     new group of anhydrous resin based direct adhesive restorative materials based on the filler     technology (PRG) have both advantages of glass ionomers namely, fluoride release and     recharge, and resin composites with excellent optical and mechanical properties. The     chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower     incidence of recurrent caries that was accepted as a major factor to retreat a resin     restoration. Limited number of studies is available on their fluoride release, and     polishability, as well as clinical survival.      The objective of this controlled clinical trial is to evaluate the clinical performance of     restorative material SI-R21204 resin composite versus a nano-hybrid resin com-posite     materials for Class I and Class II cavities that needs to be restored in per-manent teeth.40     patients are recruited to the project which is carried out at the School of dentistry,     Istanbul Medipol University, Turkey.   "
35299|NCT02823756|"     The primary purpose is to examine the impact that physical therapy (PT) interventions,     including manipulations, have on physical activity levels outside of the clinical environment     in persons with low back pain (LBP) as measured both objectively with an accelerometer and     subjectively with questionnaires.      The secondary purpose is to determine if a relationship exists between objective physical     activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk     distance, lower extremity muscle endurance.      The tertiary purpose is to assess the predictive value that a standing manual lumbar     unloading technique has for relief of pain following manipulation   "
35300|NCT02823743|"     The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with     placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy     is detected on transvaginal ultrasound (around gestational week 6+) and continues to week     35/36. The study is a single center, randomized, placebo-controlled, double blind and     stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are     enrolled, 200 in each arm aspirin / placebo.   "
35301|NCT02823730|"     To compare the incidence of major adverse cardiac events among a series of patients receiving     the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have     received the Promus Premier drug-eluting stent with durable polymer.   "
35302|NCT02823717|"     Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the     series), and are a source of potentially serious complications, even long time after delivery     (especially disorders of anal continence, psychological trauma). If a number of risk factors     are well described, the support arrangements at the time of delivery and the characteristics     of the review Proctological remote delivery and its relationship to the clinical status of     patients is little known and rarely studied.      In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients     with a diagnosis of severe perineal tear was made are taken following load with common rules,     both for the immediate repair for the remote monitoring. Patients of both sites are indeed     encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.      The same support on both sites allows to consider the creation of a relatively homogeneous     cohort in terms of support and consider an important recruitment. Moreover, the geographical     proximity of the inclusions sites (maternity) with proctology service is likely to limit the     risk of lost sight of.   "
35339|NCT02823236|"     The aim of the study is to assess the efficacy and safety of the combination of intralesional     triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8%     (every 8 hours continuously) compared with their isolated application, in the treatment of     keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a     6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated     number of persons to be recruited and randomized for the study is 102.   "
35303|NCT02823704|"     The study ia aiming to the assessment of Mid-Regional proadrenomedullin (MR-proADM) as a     novel biomarker that can provide accurate short-, mid- and long term prognostic information     in the triage and multi-dimensional risk assessment of patients in the Emergency Department     (ED). A clinical algorithm with predefined MR-proADM cut-off values: <0.75 nmol/L (low risk),     0.75 nmol/L≥ and ≤ 1.5 nmol/L (intermediate risk); >1.5 nmol/L is pre-defined. Based on these     cut-off values, a prespecified algorithm aiming to predict i) reduction of hospitalization in     the ward/ICU and increase of out-patient treatment (rule-out of risk); and ii) reduce adverse     complications (identify patients at risk) will be applied and compared with the initial     clinical decision.   "
35318|NCT02823509|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35308|NCT02823639|"     Impairments of cognition are a core, severely disabling feature of schizophrenia leading to     poor long-term outcome with no established treatment available.      Particularly impaired executive functions (e.g working memory) are frequently observed and     are consistently associated with reduced activation of the dorsolateral prefrontal cortex     (dlPFC). Deficits in those functions have been shown to be closely related to negative     symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion     that frontal lobe dysfunction is crucially important in schizophrenic psychopathology.      Noninvasive brain stimulation like tDCS can enhance executive functions like working memory     in healthy subjects as well as in patients. To identify the optimal parameters for this     intervention in patients with schizophrenia, the investigators first test the effects of     different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality     (left, right) on working-memory performance (nback task) in a sham-controlled cross-over     design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be     registered with electroencephalography (EEG).      These experiments will provide reliable data for an evidence-based development of new     clinical interventions to improve treatment of cognitive deficits in patients with     schizophrenia and thus enhance schizophrenia prevention and recovery.   "
35309|NCT02823626|"     Primary Aims        1. Evaluate the safety of high-dose spironolactone in combination of patiromer in acute          decompensated heart failure patients.        2. Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing          volume loss and symptom relief in patients with ADHF treated with high-dose          spironolactone.      Secondary Aims      1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal     function.   "
35310|NCT02823613|"     The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is     reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is     upregulated in conditions with low salt.   "
35311|NCT02823600|"     The purpose of this research study is to look at retinal abnormalities in outpatient renal     dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.   "
35312|NCT02823587|"     The purpose of this study is to assess the effect of pulmonary rehabilitation on the     transport of secretions, inflammation and respiratory resistance, and its repercussions on     the quality of life in patients with bronchiectasis.   "
35313|NCT02823574|"     A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to     evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)   "
35314|NCT02823561|"     Obesity is one of the greatest public health challenges of the 21st century. Its prevalence     has tripled in many countries of the European Region since the 1980s, and the numbers of     those affected continue to rise at an alarming rate. In addition to causing various physical     disabilities and psychological problems, excess weight drastically increases a person's risk     of developing a number of noncommunicable diseases including cardiovascular disease, cancer     and diabetes, in association or not to metabolic syndrome. The risk of developing more than     one of these diseases (co-morbidity) also increases with increasing body weight. Every year a     growing number of patient tend to suffer of more severe obesity and difficulty in losing     weight even with a restricted diet and exercise.      Garcinia mangostana (Sphaeranthus indicus extract) has known for its antioxidant properties;     new evidence point out some promising effects in the prevention of lipogenesis and the     promotion of lipolysis . Currently in the scientific literature there is only one paper, by     Stern et al., showing the association of Garcinia mangostana assumption in low-calorie diet.     This work has demonstrated a significant reduction in weight loss , compared to the placebo     group,due to the use of Garcinia mangostana.      Aim of the present study is the evaluation of safety and efficacy of weight loss in severe     obese patients. Also cardiometabolic parameters and flogosys serum indicators will be     evaluated before and after 6 month therapy of low calory diet alone or in association with     Garcinia mangostana extract.   "
35315|NCT02823548|"     PICASSO has been designed to demonstrate that combination therapy with CS/GH has superior     efficacy compared to placebo in pain reduction (average score reduction in Huskisson's 0 to     100 mm Visual Analogue Scale) from baseline to 6 months of treatment in patients with     symptomatic hand osteoarthritis.   "
35316|NCT02823535|"     The overarching objective of this proposal is to conduct a randomized trial to evaluate the     effectiveness of the Individual Well-Being Navigator (Iwin) mobile application, a substance     abuse prevention and well-being enhancement program designed specifically for military     personnel. Iwin provides an innovative, tailored mobile application using best practices in     behavior change science and innovative technology to assist military personnel in preventing     substance abuse and enhancing well-being by providing them with the most appropriate     intervention content at the right time. It integrates Transtheoretical Model of Behavior     Change based tailoring, in app messaging, stage of change matched activities, and engaging     game-like features in a cutting edge multiple behavior change program. The efficacy of the     Iwin program will be determined by tests of statistical significance indicating that     participants in the Treatment condition had lower scores on an index of substance use and     other behavioral risks. The overall design is a 2 group (treatment and control group) by 3     Occasions with repeated measures across occasions.   "
35317|NCT02823522|"     Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related     diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease     (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive     and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination     and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has     been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components     other than gluten can cause the symptoms, and therefore the term non-celiac wheat     sensitivity (NCWS) has been proposed instead of NCGS. While it is well known that CD is a     long-life condition and a strict adherence to the gluten-free diet must be maintained, it is     unknown whether this is valid for NCWS. On the year 2012, the researchers published a     retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms     who had been diagnosed with NCWS using a DBPC challenge during a ten-years period     (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients     are still following a wheat-free diet, and B) which percentage was still suffering from NCWS,     diagnosed by DBPC wheat challenge, in a subgroup of that cohort.   "
35323|NCT02823444|"     To systematically develop, test, and refine peripheral vascular electrocardiography-gated     fast spin echo magnetic resonance imaging for the accurate diagnosis of peripheral arterial     disease without gadolinium contrast.      To test prospectively the accuracy of fast spin echo in peripheral arterial disease patients,     compared with bolus-chase and time-resolved gadolinium enhanced magnetic resonance     angiography. Additionally, as a substudy of this project, we will compare our fast spin echo     approach with alternative non-contrast-enhanced magnetic resonance imaging methods such as     time-of-flight and steady-state gradient echo imaging.      The overarching goals of our research are to develop and validate a peripheral magnetic     resonance imaging technique that accurately depicts anatomy and disease without exposing     patients to exogenous contrast material and its associated risks.   "
35324|NCT02823431|"     The purpose of this study is to evaluate how urethral analgesia impacts voiding efficiency in     healthy women. The investigator hypothesizes that anesthetizing the urethral with lidocaine     gel will decrease voiding efficiency as measured by standard bladder testing (urodynamic     testing).   "
35325|NCT02823418|"     Postpartum depression (PPD) affects approximately 15% of women during the first year after     giving birth, and is common across cultures. The etiology of postpartum depression is not     totally clear. The severe pain experienced during childbirth was reported to be associated     with the development of postpartum depression. The purpose of the present study is to     evaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum     depression.   "
35326|NCT02823405|"     The goals of this protocol are 1) to investigate the safety and tolerability of X4P-001 in     combination with Keytruda® (pembrolizumab) in patients with advanced melanoma, and 2) to     assess serial biopsies of melanoma tumor lesions obtained throughout the study for     inflammatory and tumor cell infiltrates. After completion of study treatment, patients with     resectable disease will undergo surgery, unresectable patients may continue on pembrolizumab     as standard of care.   "
35336|NCT02823275|"     Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical     situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need     surgical treatment. Both cast immobilisation and functional treatment have proved to be     reliable postoperative treatment regimes. Insight into the quality of life and the level of     pain is necessary to determine if these treatments can be related to higher patient     satisfaction and earlier resumption of daily activities and work.      Objective: The aim of this study is to examine two postoperative treatments for surgically     corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short     term plaster cast fixation. The focus of this study is on quality of life, pain and the use     of pain medication, and resumption of work and daily activities.      Main study parameters/endpoints:      Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain     disability index), complications   "
35337|NCT02823262|"     The purpose of this research study is to evaluate a decision aid to help women aged 70 and     older decide on treatment for their breast cancer.   "
35338|NCT02823249|"     With this study the investigators investigate the effects of amino acids (tryptophan, leucin)     and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.   "
35327|NCT02823392|"     Unanticipated difficult airway comprises of unexpected difficult bag mask ventilation or     unforeseen difficult laryngoscopy. The incidence of difficult laryngoscopy or unanticipated     difficult intubation in children was varied from 1.2 %to 4.77% depending on general or     specific population and type of surgery. The known risk factors of difficult intubation in     children were young age, associated syndrome or congenital abnormality and obstructive sleep     apnea. Moreover, the predictors of difficult laryngoscopy by physical examination were     associated with short interincisors distance, high frontal plane to chin distance, short     thyromental distance and Cormack & Lehane classification 3 or 4. However, little knowledge is     known regarding difficult bag mask ventilation in children. The incidence of difficult bag     mask ventilation was 6.6% according to the single study. A few study reported the independent     risk factor of difficult bag mask ventilation in children which were young age, obesity, use     of neuromuscular blocking agent and airway surgery. In addition, the association between     difficult bag mask ventilation and difficult intubation are still unknown. To understand more     of difficult bag mask ventilation in children and factor-association may reduce incidence of     morbidity and mortality by identifying difficult airway, preparing personnel and equipment     tool in order to improve clinical outcome in pediatric anesthesia. The objectives of the     study were to determine the predictors of difficult bag mask ventilation and the association     with unexpected difficult intubation in children who came for elective surgery in tertiary     care hospital of southern Thailand.   "
35328|NCT02823379|"     The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered     PA program to improve and maintain high physical levels and reduce cardiometabolic disease     risk among obese AA women.   "
35329|NCT02823366|"     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European     drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in patients with PBC improves     serum liver biochemistries and survival free of liver transplantation However, about 40% of     patients do not respond to UDCA optimally as assessed by known criteria for biochemical     response. Those patients represent the group in need for additional therapies, having     increased risk of disease progression and decreased survival free of liver transplantation.     Both lab research and some clinical studies suggest that fenofibrate could improve     cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary     secretion and anti-inflammation effect. Here we start a random, open and parallel clinical     research to explore the effect of fenofibrate in the PBC treatment.   "
35349|NCT02823106|"     This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the     safety and feasibility of super-selective intra-arterial administration of verapamil and     citicoline immediately following successful endovascular thrombectomy as a potential     neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke.     This trial represents the first time that citicoline will be evaluated in human subjects as a     superselectively administered neuroprotective agent administered in an acute time frame as an     adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to     evaluate combinational therapy for acute stroke neuroprotection.   "
35330|NCT02823353|"     Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC)     approved by US and European drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in     patients with PBC improves serum liver biochemistries and survival free of liver     transplantation However, about 40% of patients do not respond to UDCA optimally as assessed     by known criteria for biochemical response. Those patients represent the group in need for     additional therapies, having increased risk of disease progression and decreased survival     free of liver transplantation. Both lab research and some clinical studies suggest that     fenofibrate could improve cholestasis in multiple ways including reduce of bile acid     synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a     random, open and parallel clinical research to explore the effect of fenofibrate in the PBC     treatment.   "
35331|NCT02823340|"     Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment.     Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and     photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and     24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients     before and after treatment. The satisfaction and adverse reactions of the research     participants were recorded at every follow-up visit.   "
35332|NCT02823327|"     This research trial studies clinical factors and gene expression analysis for prognosis in     tissue samples from patients with acquired immune deficiency syndrome (AIDS)-related primary     effusion lymphoma. Gathering health information over time and studying samples of tissue from     patients in the laboratory may help doctors learn about the prognosis of patients with     AIDS-related primary effusion lymphoma.   "
35333|NCT02823314|"     Nausea and vomiting are two of the side effects associated with the most common     antineoplastic chemotherapy treatments. The Medical Taping Concept (MTC) is an economical     technique, easy to apply. This is a technique that may help reduce nausea and vomiting after     application of chemotherapy in cancer patient.   "
35334|NCT02823301|"     The main purpose of this study is to evaluate the effectiveness and the maintenance of a     behavior change program called VAMOS (Active Life Improving Health) Program on physical     activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/     Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil,     defined according to environmental and income characteristics. Therefore, initially all     geographic areas around the HC will be visited to classify the public places as favorable     (with the presence of spaces for the practice of PA) and unfavorable environmental (do not     have spaces for physical activity). Thereafter, four HC will be selected: high income + high     environmental quality index, high income + low environmental quality index, low income + high     environmental quality index, low income + low environmental quality index. In each HC, the     volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group     and control group. The participants that will be assigned to the VAMOS group will participate     in a behavioral change program aimed at motivating changes in physical activity and eating     habits during five months (12 meetings - six weekly meetings and six fortnightly meetings),     while the control group will receive one educational lecture regarding lifestyle changes. The     meetings of VAMOS Program will be held in the dependences or nearby the HC and will be     mediated by the physical education professional previously trained. The Program will be     evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and     maintenance. The effectiveness will be assessed from measurements of physical activity,     eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid     profile before and after five months of intervention. The implementation will be assessed by     identifying the extent to which the program will be conducted as planned. The maintenance     will be estimated from revaluations of all outcomes, as measured before and after the     intervention, six months and one year after the end of the program.   "
35335|NCT02823288|"     South Africa has one of the highest rates of violence towards women globally. However, little     is known about how to prevent men's use of violence. The Sonke CHANGE Trial tests an     intervention that targets men as individuals, groups, and community members in a peri-urban     setting in South Africa. Eighteen neighborhoods will be randomly assigned to either the     intervention condition or a control group. By speaking to men at baseline, 12 months, and 24     months, investigators will learn whether violence and other health behaviors shift over time.     Alongside the trial, qualitative research will explore how the intervention took place and     why participants may change attitudes or behaviors.   "
35340|NCT02823223|"     To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr     Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous     emphysema patients in a controlled trial design setting.   "
35341|NCT02823210|"     Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common     natural evolution: a chronic phase, characterized by a major risk of vascular events,     followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN     include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer     entities. During the past years, CML became a paradigm for targeted therapy and personalized     cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many     other mutations, opened similar perspectives. However, several questions remain to be     answered in MPNs regarding the clinical implication of these major scientific discoveries:     what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of     complications and progression? Can these new biomarkers be used in the perspective of a     personalized therapy of MPNs? his project will focus on the qualification of a series of     known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with     well-annotated samples   "
35342|NCT02823197|"     The purpose of this study is to determine whether a theory- and evidence-based intervention     aiming to promote active transport for short distance travel among older adolescents is     effective in increasing attitude, subjective norm, self-efficacy, awareness and habit towards     active transport, and intention to use active transport after obtaining a driving license.   "
35343|NCT02823184|"     The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive     for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).   "
35344|NCT02823171|"     A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the     Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT]     Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral     Administration in Healthy Subjects   "
35345|NCT02823158|"     Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's     disease (PD). Several controlled randomized studies have given proof of an advantage for     operated patients as compared to medically treated patients in terms of motor outcome,     activities of daily living and health status. However these studies have addressed mostly     stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best     medical treatment (BMT) in a prospective randomized controlled trial in patients with     complicated PD who are not good candidates for STN stimulation. The investigators aim     assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.   "
35351|NCT02823080|"     To evaluate safety and efficacy of 3-day cetrotide therapy started on day of oocyte retrieval     (Day-0) in women at high-risk for development of ovarian hyperstimulation syndrome (OHSS)     after gonadotropin- releasing hormon agonist induction protocol.      Patients & Methods: Forty-eight women fulfilling inclusion criteria underwent ultrasound     scanning for maximal ovarian diameter (MOD) estimation and ascites grading. Patients     underwent embryo freezing, but study group received 3-day Cetrotide sc injection (0.25     mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value     (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading     were re-evaluated on Day-3, 6 and 8   "
35352|NCT02823067|"     The primary objective of this observational study is to describe the prevalence of pruritus     and pemphigoid in nursing home patients. Secondary outcomes are the relationships of     demographic factors and medical risk factors with pemphigoid, including dementia and     neuropsychiatric symptoms, medication use and Karnofsky score.   "
35353|NCT02823054|"     Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is     usually taking to restore coronary revascularization, and its dissection can lead to     accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the     drainage required. In this study, the investigators propose one-lung ventilation to     facilitate artery grafting and surgical procedure. The investigators will include all adult     patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in     a prospective, controlled, randomized and monocentric study. The main objective is to     demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by     presence of drainage and/or pneumothorax on X-ray chest in the ICU.   "
35375|NCT02822768|"     The goal of this study is to examine patients undergoing incision and drainage of cutaneous     abscesses to determine if routine packing of the abscess cavity affects the need for further     interventions such as repeat incision and drainage, antibiotic administration or hospital     admission.   "
35504|NCT02821052|"     This trial is conducted in Asia. The aim of this Non-interventional study is to investigate     the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in     Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical     practice conditions.   "
35354|NCT02823041|"     This is a confirmatory randomized controlled trial of the efficacy of a novel intervention     combining neuroplasticity-based cognitive training with aerobic exercise, compared to the     same systematic cognitive training alone. Treatment occurs for 6 months after randomization,     with a followup assessment at 12 months. The investigators hypothesize that combining     neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical     exercise will produce neurotrophin increases and cognitive and functional improvements, even     relative to cognitive training alone. The investigators target the period shortly after a     first episode of schizophrenia to maximize the generalization of cognitive improvement to     functional outcome, before chronic disability is established.   "
35355|NCT02823028|"     Tweet2Quit is an innovative smoking cessation intervention that combines real-time online     peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the     investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.   "
35356|NCT02823015|"     Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem,     affecting between 25 and 50% of patients. Several factors are associated with the development     of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed     model modeling is an alternative to static pain measures, improving precision and providing     information on the time course of pain resolution. Our aim was to investigate if the     characteristics of pain trajectories during the first postoperative week are correlated with     the persistence of pain 3 months after breast cancer surgery.   "
35357|NCT02823002|"     This study will collect data from multiple academic institutions. The primary objective for     part A of this study is to determine the impact of anesthetic injection rate and temperature     on pain perception during dermatologic procedures, and the objective for the part B of this     study is to determine if buffering of the anesthetic solution alters pain perception.      This study is a pilot study designed to determine feasibility of these procedures.   "
35358|NCT02822989|"     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and     musculoskeletal pain is one of the most common symptoms. This study will investigate whether     transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This     study will additionally investigate the biologic effects of vagus nerve stimulation on     inflammation. It will be the first clinical study using one of the body's own pathways of     modulating the immune system and inflammatory response, the cholinergic anti-inflammatory     pathway, in SLE.   "
35359|NCT02822976|"     Background: Glycated hemoglobin A1c (HbA1c) has been linked to poor outcomes in the cardiac     surgery, septic and critically ill patient population. It is a promising test to understand     the complex relationship between glycemia, diabetes and outcomes in patients admitted to the     intensive care unit.      Hypothesis: An elevated HbA1c value on admission to an intensive care unit (ICU) is     associated with poor outcomes.   "
35360|NCT02822963|"     Benign prostatic hyperplasia(BPH) is a common disease in urology among old men. If BPH     symptom cannot be controlled by drugs, then transurethral resection of the prostate (TURP),     is recommended. Although the procedure is quit safe, these old men often take anticoagulants     and antiplatelets to control cardiovascular diseases, which arose some concerns for their     bleeding risk. The management of anticoagulation in patients undergoing surgical procedures     is challenging because interrupting anticoagulation increases the risk of thrombotic events.     At the same time, surgery and invasive procedures have associated bleeding risks that are     increased by the anticoagulant administration. Now, the recommendation about anticoagulants     and antiplatelets discontinuation had no concrete evidence, especially in TURP. Furthermore,     there is no relative studies done in Taiwan population, which calls for further     investigation.   "
35409|NCT02822326|"     The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor     19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+     acute Leukemia.   "
35410|NCT02822313|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35411|NCT02822300|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35361|NCT02822950|"     The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the     Intensive Care Unit (12). This study will include medical and post-surgical patients who     develop an infection where Avycaz can be utilized. Since these patients will have variable PK     parameters, the investigators will also analyze (time-kill) these serum concentrations (ex     vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to     determine microbiologic activity of Avycaz in critically ill patients with variable     characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates     (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.   "
35362|NCT02822937|"     This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive     measurements to two short-acting cognitively active pharmacological agents. The participants     will receive a placebo, and two pharmacological agents in a randomized order for three     in-clinic study days. During each study day in the clinic, the participants will use Project:     EVO Monitor and another cognitive task through the day.   "
35363|NCT02822924|"     The objective is to evaluate the clinical effectiveness and safety of PAE in treating     patients with BPH.   "
35364|NCT02822911|"     Alcohol misuse affects 5 million people in France. Even though the elderly are also concerned     by this pathology, there is not much information about chronic alcohol misuse of this     population in particular.      Biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and     carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a     biological marker of alcohol misuse, the specificity of the CDT is known to be superior to     the GGT as well.      However, when it comes to the elderly, alcoholism diagnosis tools are based on research of     younger populations.      This study aims to evaluate the benefit of the CDT to detect chronic alcohol use in the     elderly.   "
35376|NCT02822755|"     The purpose of this study is to determine the effectiveness of an individualized video     recording in improving adherence in home exercise programs for orthopaedic physical therapy     patients.      Specific aims:      1. Evaluate whether individualized video recordings improve adherence with home exercise     programs (HEP) as compared with conventional printed instructions measured by a self-report     exercise log. (1-tail analysis)   "
35377|NCT02822742|"     The purposes of this study are to investigate the effect of intraocular pressure lowering     efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle     glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic     solution.   "
35365|NCT02822898|"     The prescription of intravenous maintenance solutions - although widespread - lacks important     data on the optimal sodium and potassium content, which has given rise to an important debate     in the scientific literature. Our study compares two different infusion fluids in 12 healthy     adult volunteers without renal failure in a single-blind randomized crossover design over two     48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed     solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium     chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at     25 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both     solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic     maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both     solutions is assessed by sequential analysis of urine and serum, clinical parameters and     bioelectrical impedance analysis.   "
35366|NCT02822885|"     This study was to investigate the diagnostic value of ultrasonography and blood flow     measurements in uterine arteries and spiral arteries by transvaginal color Doppler     ultrasonography in the detection of the endometrial pathology in women with postmenopausal     bleeding.   "
35367|NCT02822872|"     Infertile couples who come for evaluation and treatment in IVF unit could be under     psychological stress. Many authors in the past suggested that stress itself is one of the     factors that directly influence fecundability rate. In couples treated in IVF unit, the     investigators aim to measure chronic stress by measuring hair cortisol level (as a marker for     chronic cortisol release) and by filling different questionnaires.   "
35368|NCT02822859|"     The study will assess three different nebulizers for use in methacholine challenge testing in     order to determine if the Aeroneb Solo would make a suitable replacement for the long-used     and now obsolete Wright and Bennett-Twin nebulizers. Results from each device will be     compared to evaluate whether current guidelines for the methacholine challenge should be     updated for superior standardization.   "
35369|NCT02822846|"     The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to     monitor the position of the intubation probe.      The primary assessment criterion is of study the position of the intubation probe with two     examinations carried out independently :        -  sonography        -  chest radiography      A correct position of the intubation probe will be considered if there is :        -  Highlighting of the extremity of the intubation probe in endo tracheal        -  Highlighting bilateral lung sliding   "
35370|NCT02822833|"     Endometrial cancer is the most common gynecologic malignancy in developed countries and the     second one in developing countries following cervical cancer. The primary treatment for     endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with     adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who     have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial     cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The     primary purpose of the present study is the to investigate the feasibility of sentinel lymph     node determination in endometrial cancer patients operated via conventional laparoscopy. To     determine sentinel lymph nodes cervical indocyanine green will be injected prior to the     surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be     removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be     performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or     macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be     performed. The secondary purpose of the study is to compare the conventional laparoscopy in     sentinel lymph node mapping of endometrial cancer patients.   "
40446|NCT02756208|"     This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized,     placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult     volunteers (Human Immunodeficiency Virus-1 uninfected).   "
35371|NCT02822820|"     This single-institution prospective randomized clinical trial will be performed at the     Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix     cancer who will be operated for staging via laparoscopic approach will be included in the     study. The included patients will be randomized to two groups before surgery. During the     operation of first group instruments with advanced bipolar energy will be used during     lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation     will be performed by conventional bipolar energy forceps. The outcome parameters to be     measured are intra-operative bleeding, duration of operation, intraoperative complications,     postoperative pain score, postoperative complications, postoperative duration of     hospitalization, late complications such as lymphocele formation and costs.   "
35372|NCT02822807|"     The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii     is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is     associated with secretion by the body both many antibodies against the bacteria but also     against certain cells of the body (autoantibodies). These autoantibodies may have no effect     or be associated with specific symptoms. Anti-Phospholipid antibodies are especially     prevalent in the Q fever. Apart from this infection, they are associated with     thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These     conditions have also been described as complications during Q fever. In a retrospective     preliminary work on Q fever, we have shown that the presence of high levels of IgG     anti-cardiolipin was associated with the presence of valvular and the evolution to     endocarditis. Such associations have a therapeutic involvement and must therefore be     confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could     be systematically proposed to patients with valvular disease of trans-thoracique ultrasound     but IgG anticardiolipin high levels. Other special attention could be given to patients with     high autoantibodies.   "
35373|NCT02822794|"     The primary objective of this study is to evaluate the antiviral efficacy, safety, and     tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC)     and ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) who have previously     failed a direct-acting antiviral (DAA)-containing regimen.   "
35374|NCT02822781|"     Chronic rhinosinusitis (CRS) is a debilitating disease that remains (smell, nasal patency,     flow) because currently treatment protocols available to us are with a limited efficacy. The     assessment of the response to surgical treatment protocols and monitoring the become of     patients treated with only drugs should allow investigators to identify the predictive     patient's profile for the response. With this prospective data, this study would allow     investigators to make a classification of Chronic rhinosinusitis.   "
35380|NCT02822703|"     Tobacco use is one of the most significant cancer control and public health challenges in the     US today. Half of all smokers in the US will attempt to quit tobacco each year, but fully 95%     of those who attempt to quit will reverse this decision within 12 months and choose the     transient, albeit immediately rewarding activity of smoking at the cost of much larger     long-term rewards such as future health and long life. This project seeks to improve     scientific knowledge of these decision-making processes and potentially improve the treatment     of tobacco dependence by examining the feasibility of using a brain stimulation technique,     repetitive Transcranial Magnetic Stimulation or rTMS to improve the efficacy of an existing     evidence-based relapse prevention intervention. rTMS is an FDA-cleared treatment for     medication resistant depression and is being examined as a treatment for a variety of other     disorders. This study will utilize an intensity and duration of rTMS that is well within the     safety parameters and similar in location and intensity to that used in previous studies with     smokers to reduce cigarette consumption.   "
35381|NCT02822690|"     The aim of this study is to get insight in the quality of life at the end of life and quality     of dying for patients died at the hospital in the department Groningen (the Netherlands).      The primary endpoint is the quality of life at the end of life and the secondary endpoint is     the quality of dying. Both according a numerical rating scale.      An explorative analysis will be done for differences for the hospitals in Groningen, effect     of using the Liverpool care Pathway for the dying, effect of using consultation by the     palliative consultation team, effect of using the Hospice@UMCG intervention, correlation with     the quality of life at the end of life and quality of dying according to nurses and doctors.   "
35382|NCT02822677|"     The investigators will conduct a cross-sectional study to discovery the distribution of IBS     subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the     investigators will also collect the serum, urine and stool samples of the participants to     explore the host-gut microbiota metabolic interactions associated with IBS subtypes.   "
35383|NCT02822664|"     The main objective is to identify cerebral correlated of pedophilia using neuroimaging     techniques.   "
35384|NCT02822651|"     Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey     conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of     subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency     (<10ng/ml).      Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the     number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5     million € in 2011, and with it the costs for health insurance. However, there is currently no     consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.      We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate     assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected     through a self-administered questionnaire.   "
35412|NCT02822287|"     This is a 1-treatment arm, open label design. This 1-day study includes a screening on day of     attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if participants     are eligible for dosing the same day). The study also includes a supervised dosing with 10 mL     oral solution and a 1 hour in-clinic evaluation period.   "
35413|NCT02822274|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35414|NCT02822261|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35415|NCT02822248|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35385|NCT02822638|"     Ischemic heart disease is the leading cause of mortality in industrialized countries. ST     elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In     the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely     reperfusion (primary percutaneous intervention) and significant progression in pharmacologic     intervention.      However, death and heart failure incidence after STEMI remain elevated: up to 20% at one     year.      Also, therapeutic management following international guidelines is standardized toward a     one-size fits all therapeutic management.      In order to continue improving myocardial infarction outcomes, there is a need to better     understand and individualize therapeutic targets such myocardial reperfusion injury, post     reperfusion inflammation, adverse left ventricular (LV) remodeling ….      This knowledge will allow us to propose new therapeutic strategies and in the long run strive     towards personalized medicine.      The aim objective of this cohort of STEMI patients is to identify new biological markers of     injury and prognosis.   "
35386|NCT02822625|"     QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component     responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral     neuropathic pain in non-diabetic adults either alone or in combination with other analgesics.     Acute pain experienced during and after the procedure can be relieved by local cooling     methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via     a standardized hypnotic message would increase the local tolerance of the treatment when     applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this     hypothesis.   "
35387|NCT02822612|"     Ophthalmology is among the most technology driven of all medical specialties, with advanced     medical imaging devices - and specialised computer software - increasingly adopted for     routine clinical use. While many such devices are capable of completing specific tasks, lack     of usability prevents their widespread adoption (i.e., such devices are not easy to learn     and remember, or are not efficient or subjectively pleasing to use). Moreover, devices that     are difficult to use expose patients to clinical risk as a result of human error during     usage.      With the introduction of a new medical technology, it is essential, therefore, to have a deep     understanding of patients, what they need, what they value, their abilities, and also their     limitations.      Human factor and usability testing, also known as human factor engineering, deals with the     formal study of people's interaction with their environment (in this case, the binocular OCT     device). Structured, patient-centred, usability testing is essential to the design, clinical     validation, regulatory approval, and widespread implementation, of all new medical devices.     This is particularly the case for a putative binocular OCT system - a device intended for     automated use in visually impaired, often elderly, populations. Although the binocular OCT is     already at an advanced stage of hardware development, the EASE study will facilitate an     iterative process of operating software and workflow modifications to optimize the device for     use in these populations.   "
35388|NCT02822599|"     The goal of the study is to determine whether the use of Human Fibrinogen Concentrate     (RiaSTAP) will decrease the need for component blood therapy in neonates and infants     undergoing cardiopulmonary bypass.   "
35389|NCT02822586|"     The purpose of this study is to evaluate the cutaneous toxicity and treatment response     associated with administering concurrent TSEB and brentuximab vedotin in patients with     mycosis fungoides or Sézary Syndrome.   "
35390|NCT02822573|"     This study is to compare the safety and effects of donepezil (Aricept) or if it decreases     memory loss after receiving chemotherapy for breast cancer.   "
35391|NCT02822560|"     The present clinical trial is performed in the field of vascular surgery. The aim of the     study is the economical and clinical comparison of two different access ways to the femoral     artery with intention of endovascular repair of aortic aneurysm. The usual access is a     surgical cutdown to the femoral artery and is compared to a percutaneous access which is     closed via a suture mediated device (Perclose ProGlide, Abbott).   "
35392|NCT02822547|"     Patients will receive Peginterferon alfa-2a according to the standard medical practice but     the observation period is 12 weeks   "
35393|NCT02822534|"     SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent     approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose     study the investigators evaluated the safety, tolerability and PK/PD profiles of SP2086 in     Type 2 Diabetes Patients .   "
35394|NCT02822521|"     The overall objective of this proposal is to implement a smartphone application (app) +     population management system to monitor rheumatoid arthritis (RA) disease activity between     scheduled physician office visits. The population management system includes: 1) a web-based     dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to     identify increases in disease activity, and 2) the population manager, a trained individual     who monitors the web-based dashboard and connects patients with their HCPs. The investigators     central hypothesis is that the combined smartphone app + population management system will     improve patient satisfaction and management of RA disease activity.   "
35395|NCT02822508|"     The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and     efficacy versus placebo in adults experiencing non-idiopathic constipation.   "
35396|NCT02822495|"     This is a multicenter expanded access protocol to provide human leukocyte antigen (HLA)     partially-matched third-party allogeneic EBV-CTLs for the treatment of EBV-associated viremia     and disease for which there is no comparable or satisfactory alternative therapy to treat the     patient's disease or condition. Patients must not be eligible to enroll in clinical trials     designed to support the development and marketing approval of Atara EBV-CTLs.   "
35397|NCT02822482|"     The study consists of two distinct and sequential parts:        -  A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination          (copanlisib/cetuximab) and the RP2D        -  A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended          Phase 2 Dose)      All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in     association with Cetuximab.   "
35416|NCT02822235|"     The purpose of this study is to gather information regarding the population with moderate to     severe inflammatory bowel disease (IBD), the burden of the disease, and understand their     treatment patterns, particularly on the use of available biologic therapies.   "
35398|NCT02822469|"     Background: Different therapeutic approaches have been proposed for the treatment of TMD.     Myofascial and joint techniques, exercises, intraoral devices, thermal, electro and     phototherapy applications, are among the most common. The combination of local treatments and     adjacent structures such as the cervical region have also been studied in this area. It is     believed that the anatomic proximity, neuronal interconnections and convergent afferents from     the trigeminal and cervical areas can lead the understanding of the relationship of these     structures. In order to assess the effects of these different forms of treatment studies have     used different resources such as diagnostic imaging and biological signals, in order to     complement the clinical diagnosis. Infrared thermography has been one of the resource     assessment in the literature and it is interesting and stands out from other methods because     it is functional, non-invasive and inexpensive.      Purpose: To evaluate the thermograms concerning the masseter and anterior temporal muscles,     severity, pain, range of mandibular motion and neck disability in TMD patients, before and     after physical therapy applied to the cervical and thoracic regions.      Methods: This is a randomized, placebo-controlled study, designed to evaluate the effects of     indirect treatment on the thermography of the masticatory muscles, severity, pain, range of     motion and neck disability in individuals with TMD. These will be randomized and allocated     into two groups: GA (intervention) and GB (placebo) and assessed as: Diagnostic Criteria for     Temporomandibular Research Disorders (RDC/TMD), Fonseca´s Anamnesic Index (FAI),     Thermography, EVA, IDD-CF, Pachymetry and Neck Disability Index (NDI).      Statistical analysis: The temperature of the orofacial region, acquired through thermography     is considered the primary endpoint and as a secondary endpoint will be the evaluation of the     severity according to FAI, pain by VAS and IDD-CF, the range of mandibular motion by     pachymetry and neck disability by NDI.      Statistical analysis: The normality of the data will be verified using the Kolmogorov-Smirnov     test, which will be expressed as mean and standard deviation and/or median and interquartile     range. Repeated measures analysis of variance of two factors, post hoc Bonferroni will be     used for inter and intra-group comparisons. The significance level of p≤0.05 is set.   "
35399|NCT02822456|"     The aim of this study is to test the clinical effectiveness of IOE tube using individually     customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when     unconscious patients have no choice but tube feeding.   "
35400|NCT02822443|"     The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU)     conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on     self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on     differential effects. Moreover, the mechanisms of change of both conditions are investigated.   "
35401|NCT02822430|"     For several decades, authors are interested in the existence and meaning of painful symptoms     in a population of psychiatric inpatients. But, to date, studies specifically focused on the     impact of pain in patient populations in psychiatric hospitals are few. More recently, a     review of the literature highlights the difficulties of evaluation of pain in populations of     psychiatric patients but also the complex interrelationships between painful symptoms and     psychiatric diseases. The first national survey conducted among 172 health which evaluate     pain and its management in the field of psychiatry concluded on the need to develop research     in this area.   "
35402|NCT02822417|"     To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia     and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia.   "
35403|NCT02822404|"     Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve     renal toxic threats in children given their immature kidney. This toxicity is increased     especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the     available evaluation methods of the renal function could be very restrictive to perform on     children. In this study, the investigators intend to test the use of the cystatin C as an     effective and reliable biological marker of renal toxicity in children treated with cisplatin     and / or ifosfamide.   "
35404|NCT02822391|"     Orofacial impairment following stroke frequently involves a reduced chewing performance and     dysphagia. This study investigated the sensitivity of oral tissues following stroke and its     potential impact on chewing efficiency.      The following two Null-hypotheses (H0) were tested:      i. Post-stroke patients do not show a reduced intra-oral sensitivity compared to a healthy     controls.      ii. Intra-oral sensitivity is not correlated to chewing efficiency.   "
35405|NCT02822378|"     Postmenopausal women often seek non-pharmacologic interventions for the protection of bone     health. Previous research in humans and rodents has indicated that dietary dried plum     consumption may be beneficial for bone health, especially in postmenopausal women. However,     it is unknown in what quantity dried plums need to be consumed to be of benefit and through     what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study     is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on     bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal     women. The investigators also seek to evaluate the mechanisms underlying the effects of dried     plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated     metabolites in the urine of postmenopausal women taking different doses of dietary dried     plums. The investigators aim to further investigate the mechanisms of dried plum action on     bone by measuring markers of bone metabolism in response to dried plum consumption.   "
35406|NCT02822365|"     This pilot study tests the pocket phantom tool in improving the accuracy of quantitative     positron emission tomography/computed tomography (PET/CT) imaging of patients with solid     tumors. The pocket phantom tool may help test the accuracy of the PET/CT scanner and indicate     whether adjustments need to be made to get consistent information.   "
35407|NCT02822352|"     Colitis is inflammation of the large bowel and it is often caused by conditions known as     ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated     inflammatory response against the bowel - the body attacks the bowel. Patients who have had     colitis affecting most of the large bowel for more than 8 years are at increased risk of     cancer of the large bowel. In view of this, many national gastroenterology organisations have     recommended that such patients have regular colonoscopies to detect pre-cancerous areas and     even early cancer in the large bowel. Early detection of such areas, will lead to early     treatment thereby reducing the risk of developing significant large bowel cancer. These     regular colonoscopies are known as surveillance colonoscopies.      Official international guidelines for surveillance in patients with ulcerative and Crohn's     colitis advise to take 4 random samples of large bowel tissue (biopsies) every 10 centimeters     and of any suspicious areas. Recent studies have shown that spraying dye such as indigo     carmine (a type of food dye) helps highlight abnormal areas that could harbor pre-cancerous     cells. This technique is time-consuming, and tedious. There are no set standards of what is     considered a satisfactorily completed dye spray colonoscopy. The uptake of this technique in     the UK has not been uniform. Therefore virtual chromoendoscopy has been studied as an     alternative method to improve the detection of pre-cancerous tissue in patients with     longstanding colitis.   "
35408|NCT02822339|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35417|NCT02822222|"     The purpose of this study is to evaluate the safety of RMJH-111b, including how well it is     tolerated, and the effect of RMJH-111b on blood pressure in subjects with hypertension. The     study will also measure the amount of magnesium in the blood and urine before and after     RMJH-111b administration to evaluate what the body does to RMJH-111b (pharmacokinetics).   "
35418|NCT02822209|"     The prognosis of patients with lung cancer is related to the stage of the diagnosis : 73% of     one-year-survival rate at stage IA and only 13% one-year-survival rate at stage IV.     Controlling the timelines in a care program seems crucial to improve prognosis of lung     cancer.      The project aims to evaluate the impact of a coordinating nurse (CN) in a personalized care     program for patients of thoracic oncology.   "
35419|NCT02822196|"     HYPOTHESIS      Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block     (PVB) for acute pain control after unilateral mastectomies.      SPECIFIC AIMS      Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in     patients undergoing unilateral mastectomy      Secondary aim To compare the onset and duration of block and dermatomes blocked in both     groups To compare the need of post-operative rescue analgesia in both groups. To compare the     development of chronic incisional pain in both groups Functional outcome with respect to     daily activities.   "
35420|NCT02822183|"     This online survey presents capnography waveforms and asks the survey participants to give     feedback about their interpretation of the patient status, both in the form of a score and a     set of text to describe their interpretation.   "
35421|NCT02822170|"     The purpose of this small pilot study is to refine a combined intervention of IV amino acids     and cycle ergometry in critically ill patients, and to gather preliminary data, before     proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined     intervention.   "
35422|NCT02822157|"     This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian     tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard     chemotherapy with the possibility of crossover at the time of progression.   "
36298|NCT02810639|"     Spinal morphine has been widely provided for acute postoperative analgesia. However, the     analgesic effect of spinal morphine usually last 12-24 hours. Therefore the investigators are     interested in the pain characteristics during the 2nd postoperative day. The investigators     will also explore the regimens for pain therapy in our hospital.   "
35423|NCT02822144|"     In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65     % of whom keep long-term disability. Several multicentric randomized controlled trials have     shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on     functional disability, compared to a medical treatment alone (thrombolysis).      The timeliness of revascularisation is an essential factor of good prognosis. This     intra-arterial treatment, associated with thrombolysis if applicable, is the reference     treatment of large-vessel occlusion. The stillness of the patient is required to control the     safety of the recanalization. Currently, either a general anesthesia or a sedation can be     performed.      Several studies have shown a trend to superiority of the sedation but none was conducted with     a high level of proof methodology.      The aim of our multicentric randomized controlled trial is to compare sedation and general     anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior     cerebral circulation. The main outcome will be the efficacy on the functional neurological     prognosis at 3 months.   "
35424|NCT02822131|"     High dietary phosphate intake in the general population is associated with a higher risk for     developing kidney disease and cardiovascular disease with an increased overall mortality.     Whereas the effects of high phosphate intake on general health become clearer, almost nothing     is known about underlying mechanisms. More recently, the investigators and others found in     animal models that FGF23 stimulates the renal NaCl cotransporter NCC, the target of thiazide     diuretics, and that increased NCC activity may increase blood pressure. The investigators     could also show that increasing dietary phosphate intake in mice, increases FGF23 and NCC     activity within 3 days. Thus, the objective of this single-centre observational cross-over     study including 20-45 year old healthy male probands is to elucidate the role of dietary     phosphate on blood pressure regulation and renal handling of sodium chloride in healthy     subjects. Further the impact of dietary phosphate intake on the regulation of phosphaturic     hormones and other factors regulation blood pressure will be investigated. In addition, the     investigators will examine whether phosphate intake modulates gut microbiome composition. The     primary outcome in this study is the change in blood pressure in healthy subjects on     low-phosphate diet compared to healthy subjects on high-phosphate diet. In addition, to     assess changes in NCC activity as the main mechanism of phosphate-sensitive blood pressure     regulation, renal sodium chloride excretion after administration of hydrochlorothiazide will     be measured. The secondary outcomes of this study are: changes in renal phosphate, calcium     and potassium excretion, changes in phosphate regulation hormones such as 25-OH-Vit. D,     1,25-(OH)2-Vit. D, PTH, FGF23, dopamine in plasma and urine, changes in plasma and urinary     aldosterone levels, changes in sodium/chloride-cotransporter NCC and NaPi-IIa assessed from     urinary exosomes, and changes in stool phosphate excretion and gut microbiome composition.   "
35425|NCT02822118|"     To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of     IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was     designed. Patients were applied for central random number and were given corresponding     treatment according to inclusion sequences.The treatment group was administered the Chang'an     I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo,     150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.   "
35426|NCT02822105|"     The purpose is of this study is to assess the safety and tolerability of three dose levels of     H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult subjects.   "
35427|NCT02822092|"     This is an observational neuroimaging treatment study. This study involves examining the     neural circuitry of controlled treatment of patients presenting with a first-episode of     psychosis with risperidone. Patients who present for treatment of a first psychotic episode     with a schizophrenia spectrum diagnosis and who are eligible to undergo treatment with     risperidone will be offered participation in the study. Clinical ratings, neuropsychological     testing, neuroimaging and EEG will be conducted at baseline. Additionally, subjects will     undergo the same assessments at week 12 to determine treatment-related biomarkers. Clinical     ratings, including neurocognitive testing, will be conducted by blinded raters at study     visits during treatment. Healthy controls (N=50) will also be recruited and scanned twice     (12-week interval) to control for effects of time and practice.   "
35428|NCT02822066|"     The pupose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used     preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests     including the tumor markers to evaluate the general condition of patients. Intraoperative     US/CEUS/CT would be applied to monitor ablation lesions.   "
35429|NCT02822053|"     The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US)     -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the     investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and     laboratory tests including the tumor markers to evaluate the general condition of patients.     Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.   "
35430|NCT02822040|"     This study will attempt to validate a method of estimating root length on panoramic     radiograph by crown measurement on intraoral digital scans.   "
35431|NCT02822027|"     Infection and inflammation is related to increased encephalopathy of prematurities.   "
35432|NCT02822014|"     Objective Prospectively describe the kinetics of 18F-FDG uptake of extrapulmonary TB after     two months and at the end of TB treatment in HIV patients. Evaluate 18F-FDG-PET/CT as a TB     treatment response monitoring tool.      Design The investigators performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of     TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. The investigators     correlated evolution of FDG uptake with clinical evolution of patients.   "
35433|NCT02822001|"     The Primary objective of this study is to determine whether patients who receive sugammadex     immediately after tracheal extubation will exhibit a decrease in the incidence of     postoperative residual paralysis and an associated decrease in the incidence of postoperative     respiratory depression (which can precede critical respiratory events, CRE).      The Secondary objectives are to: a) determine whether patients receiving sugammadex will have     a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the PACU; and b) to     improve patient safety by documenting whether postoperative respiratory depression (decreased     MV below 80% and 40% of predicted MV as assessed by a Respiratory Volume Monitor) is due to     opioid administration vs. postoperative residual neuromuscular block (by comparing     postoperative VAS scores and total opioid administered).   "
35434|NCT02821988|"     It is well established that obese women are at an increased risk of stillbirth compared to     non obese women. This has led many physicians to begin antenatal testing in obese women in     the third trimester through either nonstress tests or biophysical profiles. However, there is     little evidence that antenatal testing improves fetal outcomes in obese women. The aim of     this study is to determine if antenatal testing improves outcomes in obese women and to     determine the optimal mode of testing (either nonstress tests or biophysical profiles).   "
35435|NCT02821975|"     Cognitive impairment plays an important role in functional recovery and leads to long-term     sickness absence. Therefore there is a need of a treatment specifically improving cognitive     functions. In this pilot study the investigators aim to evaluate the feasibility of using     cognitive computer training in patients with unipolar depression to enhance cognitive     performance. Further the investigators investigate whether this intervention shortens sick     leave.   "
35436|NCT02821962|"     Exercise-based cardiac rehabilitation (CR) has been shown to consistently reduce the rates of     total and cardiovascular-related mortality and morbidity. Sedentary behaviours have been     shown to be high in patients with cardiovascular disease, but it is not yet known if current     CR programming results in significant reductions in these behaviours, or whether a targeted     component is warranted. It is also unclear if self-reported sedentary time measures can     provide valid and reliable information for monitoring these behaviours in a CR setting, or     whether more objective measures are needed. The purpose of this study is to assess the     feasibility and usability of the activPAL3 devices for measuring sedentary time in a CR     setting, describe changes in sedentary time that occur with standard CR and assess whether     the addition of prompting cues from a device can result in further declines in sedentary     behaviour and improvements in clinical outcomes, health related quality of life, symptoms of     anxiety and depression, aortic stiffness, and aerobic capacity.   "
35437|NCT02821949|"     Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to     check clinically, biologically and radiologically absence of infection. This biological     evaluation is based on the CRP rate. Lots of infections may occur in this situation and could     reduce by three the patient's life duration. However it is very important to make as early as     possible a correct diagnosis of infection. CRP rate is classically higher for those patients     even without any infection. In comparison with CRP, Procalcitonin (PCT) is well-known for its     better sensibility and specificity for the infection diagnosis but has never been study in     case of active cancer. The aim of this study is to evaluate the Procalcitonin basal rate for     those patients suffering from NSCLC. It could be a simple and reliable method to use. So the     investigators decided to include each new patient with NSCLC stage IV coming for his     first-line chemotherapy without any infection sign, and to realize a Procalcitonin dosage     before the start of the treatment. This sample will be analyzed at the chemical laboratory     and the result will not be communicated to the patient physician. A new clinical evaluation     will be realized either at the hospital or by phone at day 7 to search any sign of infection.     In absence of infection, patient will be reevaluated at day 14, 21 and 30. In case of     infection, a new Procalcitonin (and CRP) dosage will be performed.   "
35438|NCT02821936|"     The purpose of this study is to evaluate the concordance between Positron E mission     tomography parametric imaging versus standard PET for the 1 year prognosis of patients with     NSCLC treated by radiochemotherapy.      The ancillary study will evaluate the interest of parametric PET imaging during the treatment     (around 42 Gray) to detect the local relapse of the lesion in order to propose a treatment     re-planification or intensification (not realized on the present study).   "
35439|NCT02821923|"     Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes     in the food industry and are also recommended to diabetic patients. Both substances are     already in use in the food industry and are freely available. Since the 1970s, beneficial     effects on oral health could be demonstrated as oral bacteria were influenced positively. A     pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit     from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the     blood vessels. In this trial, investigators aim to examine whether this effect can be found     in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.   "
35440|NCT02821910|"     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed     fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin     extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR     administered simultaneously.   "
35441|NCT02821897|"     Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months     Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus     total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted     with a multicolumn lead.   "
35442|NCT02821884|"     Transcranial direct current stimulation (tDCS) has been shown not only to improve motor     function but also increase cortical excitability and neural plasticity. Several studies     demonstrated that the combination of tDCS and different treatments are more effective than a     single tDCS alone. However, the effects of combination tDCS and neuromuscular electrical     stimulation (NMES) on upper extremity motor recovery in patients with stroke have not yet     been investigated. Taking into consideration the safety and feasibility of new medical     technology, recruitment of healthy subjects as a pilot study. And then recruit the stroke     patients to investigate the effects for the combination of tDCS and NMES on upper extremity     motor recovery in stroke.   "
35443|NCT02821871|"     All eligible subjects were randomly assigned to group A and group B sequences, each sequence     has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study     ,the investigators collected the blood samples,urine samples and fecal samples to analyze.   "
35444|NCT02821858|"     The purpose of this study is to investigate the pharmacokinetics (PK), safety and     tolerability following single oral administration of ascending doses of odalasvir (ODV) in     healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability     following single oral administration of ascending doses of AL-335 in healthy Japanese     participants (Panel 2; Sequential Design).   "
35445|NCT02821845|"     This project will characterize lower extremity eccentric muscle function among individuals     who have undergone locomotor training after spinal cord injury and will evaluate the effect     of downhill training at slow speeds - targeted to rehabilitation eccentric function of the     hip.   "
35505|NCT02821039|"     The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a     collaborative project to coordinate a team of investigators from various regions of Turkey.     The purpose of the Registry is to collect epidemiological data on patients with idiopathic     pulmonary fibrosis and other causes of UIP, and to obtain information about the natural     course of the disease and the treatment response.   "
35446|NCT02821832|"     Background:      Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts     about 6 months. Some people with less severe TB might not need to take the drugs that long.     Researchers think a PET/CT lung scan along with estimating how much TB is in the lungs might     show who will be cured after only 4 months of treatment.      Objective:      To demonstrate that 4 months of treatment is not inferior to 6 months of treatment for people     with less severe TB.      Eligibility:      People 18 65 years old who have TB treatable with standard TB drugs      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      HIV test      Sputum sample: Participants will be asked to cough sputum into a cup.      Chest x-ray      Participants will start TB drugs. They will have visits at weeks 1, 2, 4, 8, 12, and about 6     more times during the 18-month study. Visits include:      Sputum samples      Physical exam      Blood tests      PET/CT scans at 2 3 visits: Participants fast for about 6 hours before the scan. Participants     get FDG, a type of sugar that gives off a small amount of radiation, through an arm vein.     They lie on a table in a machine that takes pictures of the body.      Chest x-rays at 1 2 visits      Participants who we believe are likely to be cured at 4 months will be randomly assigned to     get either 6 months of treatment or 4 months of treatment.      Participants may be asked to join a substudy using their sputum samples or additional blood     tests.   "
35447|NCT02821819|"     The purpose of this prospective single-center study is to evaluate the laboratory outcome     after random start ovarian stimulation in oocytes donors. The study will be performed in     egg-donors but this type of treatment has the potential to be implemented in general     infertility population.   "
35448|NCT02821806|"     Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the     Expansion of T Cells for Adoptive Cell Therapy      Background:      New therapies are being developed that use a person s own immune system to fight tumors. Some     of the tumors being studied include cancers caused by viruses. Researchers want to use the     healthy cells of volunteers to perform research studies. To do this, they are collecting     lymphocytes through leukapheresis.      Objectives:      To collect healthy cells from volunteers for research studies for new cancer therapies.      Eligibility:      Healthy people ages 18 and older      Design:      Participants will be screened with a standard donor questionnaire. It asks about their health     and past medical problems. It also asks about risky behaviors that could increase their     exposure to viruses or bacteria that could be transmitted through a transfusion. Participants     will give a blood sample to make sure they are able to donate. They will have a physical     exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might     give a urine sample.      Participants will undergo apheresis. For this, a needle is placed in a vein in each of their     arms. Their blood is taken from one arm. A machine separates the white cells from the red     cells and plasma by a spinning process. The white cells are removed and directed into a     plastic bag. The red cells and plasma are returned through the needle in the other arm. The     entire procedure takes 4 6 hours.      Participants may donate every 21 days in this protocol if they choose to.   "
35449|NCT02821793|"     The main objective of study is to describe the priorities of elderly patients (70 years and     over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3     months of treatment. The main criterion is a prioritization of 4 items per patient from a     list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life     expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity,     economics.   "
35477|NCT02821429|"     Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery.     There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are     useful in order to improve this critical medical status.      Based both on a previous study conducted in the critical care unit of Purpan and on     literature we hypothesize that a combined thoracic echography score could be of interest. We     make the hypothesis that the use of a score based on thoracic combined echography (ETC =     cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in     cardiac surgery and allows to improve the characterization of the causes of this failure   "
35450|NCT02821780|"     Cerebral autosomal dominant arteriopathy with subcortical infarct (CADASIL) is a lethal     disease caused by a gene mutation that affects arteries in the brain. Symptoms include     migraines, strokes, memory loss, and dementia. There are no treatments. Researchers want to     study people who have CADASIL to learn more about it.      Objectives:      To learn more about CADASIL by studying people who have it.      Eligibility:      People ages 18-100 who were diagnosed with CADASIL in the past 5 years and can make their own     decisions      Design:      Participants will be screened in another NIH protocol.      Participants will have 3 visits over 2 years. These may include:        -  Physical exam        -  Thinking and concentration tests        -  Blood tests        -  Skin biopsy: A small skin punch is removed from the arm or leg        -  Eye exam and eye imaging tests        -  Fluorescein angiogram: A catheter is placed in an arm vein. Dye is given through the          catheter and travels      to the eyes.        -  EndoPAT: A small clamp on the fingertip measures blood volume.        -  Cardio-ankle vascular index (CAVI): Artery stiffness is tested with blood pressure cuffs          on the arms and      legs. Soft electrodes on the skin measure heart signals.        -  Brain MRI or MRA: They lie on a table that slides in and out of a tube that takes          pictures. They may get      a contrast agent in their vein. It brightens the brain so researchers can see where blood     flows.        -  CT scan of the heart: They lie on a table that slides in and out of a machine that takes          pictures.        -  They get contrast dye injected through a catheter. They may get a medicine that makes          their blood      vessels bigger or slows their heart rate.   "
35458|NCT02821676|"     Regional Anesthesia is a procedure in which numbing medication is injected around nerves that     transmit pain from areas involved in a surgery. The objective is to block the nerves so a     patient does not feel pain after surgery. Regional nerve blocks offer many advantages over     traditional anesthetic techniques, including faster recovery time, fewer side effects and a     dramatic reduction in post-surgical pain.      The use of regional anesthesia in breast reconstructive surgery, such as the latissimus dorsi     flap, has led to major improvements in patient care. Today, the most common regional     anesthetic used in latissimus dorsi flap reconstruction is the intercostal nerve block, where     numbing medication is injected around the nerves supplying the chest wall.      While intercostal nerve blocks have been used successfully in breast surgery, they do not     provide a complete nerve block to the chest wall, as there are some nerves that are     unaccounted for in the block which can contribute to a patients pain after surgery.      The mixed pectoral one / serratus plane block (PECI/SPB) block is another regional nerve     block that has been successfully used by anesthesiologists at The Ottawa Hospital and offers     a more complete pain blockade than the intercostal nerve block, as it includes more nerves     that supply the breast. In addition to this, the intercostal nerve block is a so-called     blind-technique compared to the PECI/SPB block, which is more accurately guided by     ultrasound. Blind techniques are associated with higher failure rates.      Both the intercostal nerve block and the PECI/SPB nerve block have been used successfully at     the Ottawa Hospital. In this study, the investigators propose a prospective, double blinded,     randomized controlled, head to head comparison of the PECI/SPB and intercostal nerve block to     determine which block is associated with the best pain blockade and patient satisfaction in     lattissimus dorsi flap surgery.   "
35459|NCT02821663|"     Systemic sclerosis is a systemic connective tissue disease with physical and mental     disturbances. Based on a pilot study the feasibility and effectiveness of a novel,     self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical     guidance and music therapy is assessed.   "
35451|NCT02821767|"     Background:      The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people     with eye diseases.      Objective:      To examine and treat people with eye diseases and learn more about eye diseases and how they     are inherited.      Eligibility:      People with eye diseases who can give consent or have a guardian who can consent for them      Design:      Participants will be screened with an eye exam.      Participants will have 1 12 visits per year depending on their eye disease for up to 5 years.     Visits last about 4 hours and could include:      Medical and family history      Physical exam      Eye exam and photography.      Oculography: They put on contact lenses or goggles. They watch spots on a computer      screen for 20 30 minutes.      Electrooculography: Small metal disks are placed on the skin next to both eyes. They look     left      and right in the dark and light for about 30 minutes.      Electroretinography: They sit in the dark with their eyes patched. A small metal disk is     taped      to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They      watch flashing lights.      Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is      injected through the tube and travels up the blood vessels in the eyes. Pictures are taken of     the      eyes.      Immunosuppressive treatment      Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small      biopsy sample from the surface of the eye.      Blood tests      Skin, tear, urine, saliva, stool, or hair sample      Exam under anesthesia for some children      At each visit participants could get medications, eye drops, eye injections, laser     treatments, or surgery.   "
35452|NCT02821754|"     BACKGROUND:        -  Various tumor ablative procedures and techniques have been shown to result in          immunogenic cell death and induction of a peripheral immune response. The term ablative          therapies applies to trans-arterial catheter chemoembolization (TACE), radiofrequency          ablation (RFA) and cryoablation (CA).        -  The underlying hypothesis of this study is that the effect of immune checkpoint          inhibition can be enhanced by TACE, CA and RFA in patients with advanced hepatocellular          carcinoma (HCC) and biliary tract carcinomas (BTC). We have already demonstrated proof          of principle as well as safety and feasibility of this approach with anti-CTLA4 therapy.        -  Based on the concept of PDL1-mediated adaptive resistance and the emerging role of PD1          therapy in HCC, we would like to evaluate the combination of tremelimumab and durvalumab          (with ablative therapies) in HCC and BTC.      Objectives:      - To preliminarily evaluate the 6-month progression free survival (PFS) of combining     tremelimumab and durvalumab in patients with advanced HCC (either alone or with cryoablation,     TACE or RFA) and in patients with advanced biliary tract carcinoma (BTC) (either alone or     with cryoablation or RFA).      ELIGIBILITY:        -  Histologically or cytologically confirmed diagnosis of HCC or biliary tract carcinoma OR          histopathological confirmation of carcinoma in the setting of clinical and radiological          characteristics which, together with the pathology, are highly suggestive of a diagnosis          of HCC (or biliary tract carcinoma).        -  Childs-Pugh A/B7 cirrhosis only is allowed. If patient does not have cirrhosis, this          limitation does not apply.        -  Patients must have disease that is not amenable to potentially curative resection,          radiofrequency ablation, or liver transplantation.      DESIGN:      We will evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in     cohorts A (HCC; N=40) and B (BTC; N=30). The first N=10 patients in both cohorts will receive     tremelimumab and durvalumab only (i.e. No interventional radiologic procedures).        -  A: Advanced HCC, BCLC# Stage B/C             -  N= 1st 10 pts: No ablative procedure Cryoablation/RFA/TACE##             -  Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28               days until EOS###             -  40 total: 10 trem+ dur alone; 10 trem+ dur + TACE; 10 trem + dur + RFA; 10 trem +               dur + cryo        -  B: Intra/extra-hepatic cholangiocarcinoma             -  N= 1st 10 pts: No ablative procedure; RFA/ cryoablation             -  Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28               days until EOS###             -  30 total: 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem                  -  BCLC = Barcelona clinic liver cancer staging system                       -  For BCLC stage B patients TACE may be repeated as per standard of care                            -  EOS = End of study treatment or meeting any of the off-treatment or                              off study criteria.   "
35478|NCT02821416|"     This is a randomized, double-blind, parallel group, placebo-controlled study designed to     evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4     weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an     inhaled allergen.   "
36631|NCT02806232|"     The Phase II study consisting of two parts, part 1 is open label, randomized, controlled and     exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni.     Part 2a investigates efficacy and safety in children 3 months to 2 years in an     age-de-escalating design and part 2b is optional and investigates the efficacy of L-PZQ in S.     hematobium.   "
35453|NCT02821741|"     Background:      The vagus nerve runs from the brain to many organs. Stimulating it can affect the experience     of pain. The nerve can be stimulated on the surface of the left ear. Researchers want to     study how this stimulation affects the perception of pain. They also want to study how mood     affects the experience of pain.      Objective:      To study the effects of mood and vagus nerve stimulation on the experience of pain.      Eligibility:      Healthy people ages 18 and older who are fluent in English      Design:      Participants will be pre-screened with a 15-minute phone call.      Participants will have three 2-hour visits.      At the screening visit, participants will be screened with:      Medical and psychiatric history      Physical and psychological exams      Questionnaires about physical and psychiatric health and mood      Urine tests      A heat probe on the forearm. The temperature will be increased until it is painful      but tolerable.      Participants will have 2 testing sessions within 7 days. Before the testing, they cannot do     the following:      Eat, use nicotine, or exercise for at least 2 hours      Drink alcohol for 24 hours      Take certain medicines for 3 days      Testing includes:      Urine drug screening      Left ear stimulation: In one session, the vagus nerve will be stimulated. In the other, an     area      of the ear away from the vagus nerve will be stimulated. This will be done with mild electric      shocks that cause a tingling, pricking, or itchy feeling.      Heat applied to the forearm until it is painful but tolerable      Completing several forms on a computer or on paper about how they are feeling      Monitors on the chest and a finger clip to monitor heart, breathing, and blood pressure   "
35454|NCT02821728|"     This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences     in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made     between participants randomised to the broccoli-rich diet and those randomised to the     non-intervention arm.   "
35455|NCT02821715|"     This Phase 2 study is a 3-site, double-blind, randomised, placebo-controlled, 3-way     cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102     (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).   "
35456|NCT02821702|"     This study is the first to investigate the fertility outcome and the influence on ovarian     reserve after using uterine artery embolization during cesarean delivery.   "
35457|NCT02821689|"     Interstitial lung disease (ILD) is a common complication of dermatomyositis (DM) with     prevalence up to 65%, and is considered to be one of the determining factors of prognosis.     Clinical amyopathic dermatomyositis (CADM), which is a special phenotype of DM, with     characteristic cutaneous manifestations but no or only subclinical myopathy. Many studies,     mainly from Asia, including ours, have demonstrated that these patients with CADM tend to     develop a rapidly progressive ILD (RPILD) and have a poor response to conventional therapy,     such as high-dose corticosteroids and immunosuppressants, leading to lethal outcome with a     6-month survival rate of less than 50%.      Pirfenidone, a new oral antifibrotic agent, has been approved for the treatment of idiopathic     pulmonary fibrosis (IPF). Randomized controlled trials of pirfenidone in patients with IPF     suggested that it could ameliorate pulmonary function decline and improve the     progression-free survival. Its utility in connective tissue disease (CTD) related ILD has     been implicated, but no evidence has yet demonstrated its efficacy. Therefore, the     investigators conduct this study to evaluate the possible therapeutic effects of pirfenidone     on RPILD associated with CADM.   "
35460|NCT02821650|"     The present study documents a randomized controlled study investigating the efficacy of     improved cookstove on the personal exposure to air pollution and the respiratory health of     women and children in an Indian slum. The improved cookstove is based on co-creation of a     low-smoke chulha with local communities in order to support adaption and sustained uptake.     The study is conducted in a non-notified slum in Bangalore, India. The study design is be a     1:1 randomised controlled intervention trial, including 250 households. Outcomes include     change in lung function (FEV1/FVC), incidence of pneumonia, change in personal PM2.5 and CO     exposure, incidence of respiratory symptoms (cough, phlegm, wheeze and shortness of breath),     prevalence of other related symptoms (headache and burning eyes), change in behaviour and     adoption of the stove.   "
35461|NCT02821637|"     Obese and overweight children or teens can join the Prevention and Care of Pediatric Obesity     and Pediatric Diabetes Organization of Mulhouse. Those patients who are no longer able to     exercize because of their physical condition start an effort rehabilitation program at the     Organization. The study will evaluate the impact of this rehabilitation program on quality of     life and appetency to physical activity for these children and teens.   "
35462|NCT02821624|"     This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data     for G1T38 in humans and will allow further development of G1T38 in patients with cancer.   "
35463|NCT02821611|"     The professional program in Physical Therapy is rigorous and demanding on students, resulting     in high levels of fatigue, stress, and sleep disturbance that can impact student performance     and wellbeing. This project seeks to investigate ways to reduce student stress, monitor their     quality of sleep and possibly enhance their learning through the practice of meditation.   "
35464|NCT02821598|"     This study aims to evaluate the effects of Proprioceptive Neuromuscular Facilitation (PNF)     patterns delivered to the upper limb, lower limb and trunk for promoting motor irradiation to     the contralateral lower limb.   "
35465|NCT02821585|"     Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic     syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin     resistance) that increase the cardiovascular risk. The investigators have observed in     previous studies a strong association between the adherence to a Mediterranean diet and the     prevalence of metabolic syndrome on patients with metabolic syndrome. However, no     intervention has been realized on this population and the current recommendations (low fat     diet) differ from the Mediterranean diet. A nutritional intervention on the principles of the     Mediterranean diet could therefore play a role in the treatment of the metabolic syndrome in     Type 1 diabetes patients. The main objective of this study is to examine the impact of a     nutritional intervention on the waist circumference after 6 months of an intervention group     (Mediterranean diet) versus a control group (low fat diet).   "
35499|NCT02821117|"     The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash     Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for     the self-management of diabetes.   "
35466|NCT02821572|"     Autoimmune thrombocytopenia, also called immune thrombocytopenic purpura (ITP) is an     autoimmune disease, characterized by the peripheral destruction of platelets of immunological     origin and the inappropriate medullar production of platelets.      Monocytes/macrophages play a double role by phagocyting platelets recognized by     autoantibodies and by maintaining the autoimmune response via their function as antigen     presenting cells. The functions of macrophages are partially regulated by binding with     Immunoglobulin G at their receptors (FcγR) which could be inhibiting, FcγRIIb, or activating     (FcγRI, FcγRIIa, FcγRIII). Therefore, a disequilibrium in the FcγRIIa/FcγRIIb ration could be     implicated in ITP, as already reported for other autoimmune diseases like rheumatoid     arthritis (RA) and systemic lupus erythematous (SLE) The aim of this project is to compare     the expression of FcγR in patients with ITP who have been treated with rituximab with that in     matched healthy subjects. A correlation between relative expression of these different FcγR     (FcγRIIa/FcγRIIb ratio) and the response to splenectomy and to rituximab will be studied.      This study is interventional because of a lots of blood sample The results of our study will     in due course make it possible to define predictors of the response to treatments, so as to     better identify patients likely to benefit from these different treatments.   "
35467|NCT02821559|"     Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil     (5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as     well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is     administered in 15-minutes infusion, complications related to continuous infusion can be     avoided, and it becomes a potential good candidate for locoregional treatments as hepatic     intra-arterial or intra-peritoneal infusion. Despite these potential benefits over 5FU,     clinical trials failed in their temptation to replace the 5FU in colorectal cancer patients,     mainly due to raltitrexed toxicity at 3mg/m2 every 3 weeks. Oxaliplatin has demonstrated a     synergic effect when combined with TS inhibitors, and its association with raltitrexed was     evaluated at 130mg/m2 of oxaliplatin and 3mg/m2 of raltitrexed, every 3 weeks. Actually, one     of the first-line standard regimens in metastatic colorectal cancer patients is the biweekly     FOLFOX (85mg/m2 of oxaliplatin, and infusional 5FU) plus bevacizumab regimen, since a     significant progression-free survival (PFS) benefit was observed over FOLFOX plus placebo.     Biweekly administration of raltitrexed at 2mg/m2 demonstrated a favorable toxicity profile     even in patients aged >65 years. Besides, the association of raltitrexed, oxaliplatin and     bevacizumab seems safe.      Then, the investigators decided to perform a randomized pharmacokinetic comparative study     between biweekly TOMOX (raltitrexed 2 mg/m2 and oxaliplatin 85mg/m2) and triweekly TOMOX     (raltitrexed 3 mg/m2 and oxaliplatin 130mg/m2) regimens in metastatic colorectal cancer     patients, in a ping-pong crossover strategy to reduce the intra-individual variability.     Bevacizumab was allowed at the dose of 5mg/kg or 7.5mg/kg, in biweekly and triweekly     schedules, respectively. The secondary end-points were, objective response rate evaluated by     RECIST 1.1 criteria, PFS, overall survival (OS), toxicity, and the comparison of toxicity     between two arms for the first 2 cycles.   "
35468|NCT02821546|"     Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary     research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography     (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of     peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP     pancreatitis.   "
35469|NCT02821533|"     The aim of the current study is to study the safety and effectiveness of TACE using a high     dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and     it improves the therapeutic effect of conventional TACE.   "
35470|NCT02821520|"     To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination     with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).   "
35482|NCT02821364|"     PIPT Trial (Philadelphia Immediate Transport in Penetrating Trauma Trial) A prospective     randomized clinical trial comparing pre-hospital procedures to immediate transportation in     patients with penetrating injury and shock.   "
35471|NCT02821507|"     Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient     survival. Current treatment options consist of wide surgical resection, however for patients     with a local recurrence or metastatic disease the outcome is poor. New treatment options     being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR)     inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and     thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in     cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma     treated with mTOR inhibitors have been conducted and they show promising results. From these     studies the investigators can conclude that the combination of an mTOR inhibitor with     cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment     options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc     consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according     to a common protocol with the combination of sirolimus and cyclophosphamide using the growth     modulation index for evaluation in the current clinical study protocol.   "
35472|NCT02821494|"     A phase I study to establish the highest safe dose that induces HPV16 E6-specific T-cell     responses, using the highly promising novel therapeutic vaccine concept named: Hespecta (HPV     E Six Peptide Conjugated To Amplivant®) to induce HPV16 E6-specific T-cell responses.   "
35473|NCT02821481|"     The purpose for this study is to determine if beta-alanine supplementation combined with     endurance-based resistance training can increase gains in muscular endurance to a greater     extent than endurance-based resistance-training alone in older adults.   "
35474|NCT02821468|"     A previous multicenter trial led by Bioiberica S.A. has confirmed the efficacy and safety of     DROGLICAN for the treatment of osteoarthritis (OA) in patients with severe pain. The MOVES     study was a phase IV, double blind, randomized and non-inferiority trial to compare the     efficacy and safety of a fixed dose combination of glucosamine hydrochloride (GH) +     chondroitin sulfate (CS) (DROGLICAN) versus celecoxib in patient with symptomatic knee OA     with moderate to severe pain. This study concluded that both drugs reduced the WOMAC Pain     subscale by 50% without significant difference between groups. Further, there was no     difference in all secondary outcomes assessing patient's pain, functional capacity,     stiffness, inflammation, joint swelling, effusion, and overall quality of life.      This new exploratory trial is aimed to evaluate the beneficial effect of DROGLICAN on the     good health of the cartilage of patients suffering of knee osteoarthritis as revealed by     qualitative assessment of cartilage biochemical composition in vivo.   "
35475|NCT02821455|"     The aims of the study is to determine if end-tidal concentrations of the anaesthetic gases     isoflurane and sevoflurane as measured by a standard gas monitor are related to the blood     levels during one-lung ventilation.   "
35476|NCT02821442|"     To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful     CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6     months prior   "
35479|NCT02821403|"     Working Hypothesis: The blue-light blocking lens has no effect on the contrast sensitivity,     accommodative response, color vision, and subjective grading of the quality of life and     vision.      Purpose: To determine and compare the visual performances after wearing the blue-light     blocking lenses in participants with and without presbyopia.      Methods: One hundred and sixty computer users (computer usage >2 hours/day) with (n=120, aged     >40years) and without presbyopia (n=40, aged 18-35 years) will be recruited. Three pairs of     ophthalmic lenses will be prescribed for the participants, in which one pair of them will be     the blue-light blocking lenses (StressFree, Swisscoat, HK). The lenses will be used for     intermediate vision (i.e., computer usage) in presbyopic group, and for distant vision in     non-presbyopic group. The adaptation period for each pair of lenses will be 1 month. The pre-     and post-treatment contrast sensitivity, accommodative response and color vision will be     measured. The participants will also be asked to complete questionnaires about their quality     of life and vision, and the performances of these ophthalmic lenses.      Significance: The blue-light blocking lens reflects the short-wavelength lights and protects     the retina from blue-light hazards; however, blue lights are essential for various visual     function and circadian rhythms. This study will evaluate the impact of the blue-light     blocking lenses on visual function and quality of life, and determine whether the blue-light     blocking lenses are good choices for extra ocular protection.   "
35480|NCT02821390|"     The analgesic effect of Nepafenac 0.1% Ophthalmic Drops on ocular pain related to     intravitreal injections will be evaluated.      Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.   "
35481|NCT02821377|"     Introduction: Patients with chronic liver diseases are usually thin as a result of     hypermetabolism and malnutrition expressed by reduced levels of leptin and impairment of     other adyponectins such as visfatin.      Aims: To evaluate the metabolic and inflammatory effects of intravenous high-dose furosemide     plus hypertonic saline solutions (HSS) compared with repeated paracentesis and a standard     oral diuretic schedule, in patients with cirrhosis and refractory ascites.      Methods; All consecutive cirrhotic patients with refractory ascites unresponsive to     outpatient treatment will be enrolled . Enrolled subjects will be randomized to treatment     with intravenous infusion of furosemide (125-250mg⁄bid) plus small volumes of HSS from the     first day after admission until 3 days before discharge (Group A ), or repeated paracentesis     from the first day after admission until 3 days before discharge (Group B, ).      Plasma levels of ANP, BNP, Leptin, visfatin, IL-1β, TNF-a, IL-6 were measured before and     after the two type of treatment.   "
35485|NCT02821325|"     The purpose of the study: is to quantify the amount of post-operative effusion or hematoma     present after total knee arthroplasty pre-operatively, post-operative day #0,1.      Patients undergoing a total knee arthroplasty will undergo an MRI on the operative knee at     the following times:        -  Pre-operatively        -  Post-operative day #1 (approximately 16-20 hours post op)        -  Post-operative day #2 (approximately 36-40 hours post op) This will be conducted by the          Loma Linda radiology department as per normal protocols. No special imaging procedures          will be undertaken.      Subjects will be both male and females, they will be patients from the Principle Investigator     and Co-Investigators practice. Subjects will be between the ages of 18-89 years of age.      The total participation will last approximately 30 days.      Subject selection will be approximately 10 English speaking, both male and female between the     ages of 18 to 89 years of age. Subjects will be recruited from the Principal Investigators     and Co-Investigators clinic. There will be no advertising or electronic recruiting. The study     is expected to last 12 months.   "
35486|NCT02821312|"     This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study     to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral     Administration of DA-8010 in Healthy Subjects.   "
35487|NCT02821299|"     The experience of face and hand composite tissue transplantations reported in the     international community have mainly concerned trauma patients. Feasibility and individual     benefit have been demonstrated for these indications, in properly selected patients. The     first laryngeal transplantation also concerned a case of post-traumatic reconstruction. A     certain number of patients, who have suffered direct (extended period of intubation during a     stay in the ICU, road traffic accident etc.) or indirect trauma (thermal or chemical burns)     to the larynx, present irreversible trauma or injury to the larynx in which conventional     treatments are unable to restore laryngeal function. These patients find themselves severely     disabled, with a significant reduction in their quality of life. They suffer from     stigmatization which leads to social isolation (professional and personal). In some     circumstances, providing healthy tissue and anatomical or functional components (cartilage,     muscle, nerves, blood vessels) by means of an allogeneic laryngeal transplantation, is the     only way of allowing patients, whose quality of life has been seriously affected, to speak,     breath and swallow normally. The extremely promising results from other international teams     in this area have encouraged the investigators to present this project.      The specificities of the protocol compared to previous transplantations carried out by other     teams are:        -  The technique for nerve re-innervation which should make it possible to decannulate all          patients and improve functional outcomes in the graft.        -  A dual therapy immunosuppressive regimen will be used, if the patient's clinical and          biological status permits, which can be adjusted according to the type of tissue          grafted.      It might be thought that the need for immunosuppressive therapy means the indications will     remain rare, representing an incidence of less than five patients a year in France. However,     the interest of this research project does not reside in the number of patients concerned but     rather the total lack of any existing therapeutic solution. Conducting a case series will     help determine whether, under certain conditions, laryngeal transplantation can improve the     management of patients for whom the usual reconstructive surgery options are unsatisfactory.      The study is intended to provide a descriptive analysis of a case series of three laryngeal     transplantations before and after comparisons, each patient serving as their own control.   "
35488|NCT02821286|"     This project intends the analysis and profiling of specific antibodies against major peanut     allergens in peanut allergic individuals and molecular cloning of human antibodies against     major peanut allergens.   "
35489|NCT02821273|"     In preterm infants with respiratory distress syndrome, mechanical ventilation is related to     increased risk of death and complications. Surfactant is an important methods to reduce     mortality and intubation rates. INSURE technique is a standard method to administrate     surfactant. However, several preterm infants need two or more surfactant, and therefore one     more intubation is needed. How to reduce the times of intubation is an challenges for     neonatologists.   "
35500|NCT02821104|"     This study evaluates how genetic variations in complement, a part of the immune system,     affect cardiovascular risk in adolescents.   "
35571|NCT02820181|"     Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be     securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged     as needed. However, the process of ties exchange is always risky and complicated. A novel     tracheostomy tie has been designed to ensure the safety during exchanging and conveniences of     cleaning. This study is to determine if the new device is better than the old one.   "
35490|NCT02821260|"     The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader     center for surgery of epilepsy in infants and children.      Postoperative follow-up of these children is performed during medical and neurosurgical     consultations in order to assess the frequency of attacks and to reduce medication.      On average, two postoperative consultations are carried out between 3 and 5 months and     between 12 and 18 months. Beyond 18 months, some children may benefit from long-term     monitoring at this center, but most children are followed by their neurologist .      Therefore, the center has no rigorous and systematic collection of standardized data on the     outcome of these patients.      The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children     with a monitoring of 3 years.   "
35491|NCT02821247|"     This is a prospective, observational, multi-center, study. The study will be conducted in     approximately 12 ophthalmological clinics and practices throughout Greece. It is planned to     collect data on treatment of wet Age related Macular Degeneration (wAMD) from about 120     patients for which the decision to treat with intravitreal aflibercept injections is made at     the discretion of the attending physician, according to his/her medical practice. Visits will     be performed at baseline, aflibercept first injection (if different from enrollment) and at     12 and 24 months. The 12 and 24 month comprise the data collection visits during which any     data generated in the period preceding these visits will be recorded.      All required information for the purposes of this study will be collected using electronic     Case Record Form (eCRF). The web-based electronic data capture (EDC) application will be     specifically designed for the needs of the study and will adhere to all applicable data     protection regulations and requirements with regard to electronic records.      The study observation period for each patient enrolled in this study is the time from the     beginning of treatment with intravitreal aflibercept injection up to two years or until     discontinuation of intravitreal aflibercept injection-treatment due to any reason including     withdrawal of consent or patient loss from follow-up.   "
35516|NCT02820896|"     This is a Phase I, randomized, placebo-controlled, double-blind study to evaluate the safety,     tolerability, pharmacokinetics, and preliminary activity of RO7105705 in two participant     populations: healthy participants and participants with mild-to-moderate Alzheimer's disease.     This study is a single dose, dose-escalation, and multiple dose study comprising     approximately six single dose cohorts in healthy participants administered RO7105705, either     intravenously (IV) or subcutaneously (SC), and comprising one or more multiple dose cohorts     in healthy participants administered RO7105705 IV every week (QW), a total of 4 doses, and     one or more multiple dose cohorts in participants with Alzheimer's disease administered     RO7105705 IV QW, a total of 4 doses.   "
35517|NCT02820883|"     This is an open-label, dose-escalation pilot study with a total of 30 participants with 10     per dosage group. The aim of the pilot study is to explore the preliminary safety of an     experimental recombinant staphylococcus aureus vaccine.   "
35492|NCT02821234|"     One-tenth of the population suffers from insomnia, increasing their risk on other health     problems such as depression. Self-reported sleep quality only was historically leading for     insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated     with insomnia, either physiological (increased heart rate, higher frequency EEG) or     predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts). Strong     evidence shows that those suffering from insomnia with physiological hyperarousal are at     higher risk of short and long term severe health problems such as inflammation and     hypertension than the group without physiological hyperarousal. The neurophysiological basis     of these insomnia phenotypes has however barely been investigated, although its results can     have major consequences for how this limiting condition will be treated.      To support the development of a differential diagnosis of insomnia, structural and functional     brain connectivity in insomnia patients with different levels of hyperarousal will be     investigated and related to sleep variables. Investigators will compare the insomnia group to     a normal sleeping control group. Investigators expect that the emotion processing circuit     (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared to     normal sleeping controls and b) the directionality of this effect to depend on the level and     type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity to be     positive correlated with physiological hyperarousal level and d) prefrontal activity to be     positively correlated with cognitive-emotional hyperarousal level. Investigators expect a     higher physiological hyperarousal level to be reflected in affected afferent pathways of the     amygdala towards the ventromedial prefrontal cortex and investigators expect higher     cognitive-emotional hyperarousal to be related to affected efferent pathways from the     ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a     mediating role in both types of hyperarousal and their brain activation patterns in insomnia     patients and normal sleeping controls.      These data can lead to the definition of new insomnia phenotypes and to new customized and     effective insomnia treatment, focused not only on improving sleep but also on changing     dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe     health problems.   "
35493|NCT02821208|"     The goal of this study is to identify the prognostic factors of quality of life in patients     with psychogenic non-epileptic seizures   "
35494|NCT02821182|"     We hypothesize that combining anti-PD1 treatment with radiotherapy might result in improved     clinical response rates and PFS compared to anti-PD1 treatment in monotherapy.      The current phase II trial aims at exploring the suggested benefits of the combination and     aims to improve local and distant tumour responses by exploiting the pro-immunogenic effects     of radiotherapy in addition to anti-PD1 treatment.   "
35495|NCT02821169|"     Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many     chronic rhinosinusitis for whom the medical treatment failed. In order to improve the     postoperative management of patients treated with ESS, we aim to assess the analgesic action     of local injection of ropivacaine in the nasal fossa.   "
35496|NCT02821156|"     This is a prospective, observational, multicenter study conducted during 1 year in adult and     paediatric intensive care units equipped with the EZ-KINOX™ system.      A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension     (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn     (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was     planned to be included.      The study is strictly non-interventional with the aim of describing current practices and     therefore did not affect the patient usual management.   "
35497|NCT02821143|"     Investigators hypothesize that telemedicine may be an effective tool to improve palliative     care in nursing home, by providing on-site specialized and interprofessional consultation.     The objective of this study is to assess the impact of telemedicine in decreasing the rate of     hospitalization, compared with usual care, in nursing home resident with palliative care     needs.   "
35498|NCT02821130|"     Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly     reported symptom in patients with cystic fibrosis (CF). A recent treatment option known as     Orkambi, which combines the drugs lumacaftor and ivacaftor, may be used in patients with CF     to help improve lung health. However, the effects of this combination therapy on dyspnea and     exercise performance, a known predictor of survival in CF, are not clear. The investigators     aim to understand the effects of Orkambi on these symptoms and to gain new insight into the     potential health improvements in CF from using this treatment option.   "
35501|NCT02821091|"     Aim 1: Determine the relationships between muscle quality and balance performance as well as     any association with fracture and fall history in older adults.      Muscle quality will be calculated from the information of muscle strength and body     composition (strength/lean muscle mass). The investigators will compute the joint torque     during functional activates using biomechanical data from the 3-D motion analysis, whereas     the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis     (BIA). Clinical and functional assessments for balance performance will also be conducted.     Fracture and fall history prior to the testing will be recorded retrospectively.      Aim 2: Identify the relationships between force usages during balance perturbation in older     adults.      Lateral and forward/backward perturbation while walking will be used to elicit balance     recovery responses. The degree of necessary joint force and how this relates to a person's     functional capacity at specific joint levels will be determined by the torque demand to     capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a     joint-specific unified scalar quantity representing the balance recovery demand normalized by     the maximum muscle strength capacity of an individual. It would indicate whether a person can     recover balance and to what extent of his/her maximum capacity is taxed.      Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized     strengthening and balance training program on improving balance performance in older adults.      Personalized strengthening and balance training exercise will be personalized based on the     results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and     split-belt balance perturbation instrumented treadmill. The exercise group will receive     training 2 times a week for 2 months and the age-matched control group will maintain their     usual daily life activities. All assessments will be performed at baseline, and 1 week after     training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following     the training period.   "
35502|NCT02821078|"     The objective of the project is to establish the 3D velocity mapping of the hepatic     vasculature and its consistency. Specifically, the investigators will assess the consistency     of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein) and     outflow (inferior vena cava differential flow). According to the mass conservation physical     property, blood inflow must equals blood outflow. The relative gap between the measured     values will characterize the consistency of the acquisition.   "
35503|NCT02821065|"     Modern technology like computers, smartphones and the Internet enable patients to measure     certain health indicators, like blood pressure and body weight, from the comfort of their own     homes. This information can also be shared electronically with doctors and other healthcare     providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are     developing a home monitoring solution for patients with heart failure to support their care     and recovery at home after a visit to the emergency department. We hope to show that this     solution decreases revisits to the emergency department and increases quality of life for     patients.   "
39692|NCT02766075|"     The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP)     can safely improve the frailty status in patients with symptomatic severe aortic valve     stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).   "
35506|NCT02821026|"     Islet transplantation is a relatively new procedure used in people with difficult to control     Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas of a deceased     organ donor. After the cells are carefully prepared, the islets are transplanted into     patient's body. These transplanted islets may produce insulin for the patient. Patient may be     able to reduce or eliminate the need for insulin injections for an unknown period of time.     Patients who receive an islet transplant may need to stay on powerful immunosuppressive drugs     for as long as the islets remain alive and working. These drugs help to prevent the immune     system from attacking the transplanted islets.      Under current standard of care procedure, islets are transplanted into patient's liver. The     investigators have learned that some of these cells do not survive the current procedure and     are lost around the time of transplant. Therefore in this study, the investigators are     studying a new transplant procedure that may help prevent this islet cell loss. The new     procedure involves transplanting the islets into an omental pouch instead of into the liver.     The omentum is a large apron-like fold of membrane inside the abdomen that drapes over the     intestines. This study will test to see if omental islet transplantation is safe and     effective. Standard immunosuppressive medicines (anti-thymocyte globulin, tacrolimus,     mycophenolic acid, sirolimus, etanercept) will be used in this study to prevent rejection of     the islets.      This study is a collaborative research with the University of Miami, and the same study     protocol has been in use over there. Recruitment in Edmonton will continue until all subjects     [N=6] needed for the study are transplanted. All subjects in this study will receive islet     transplants using the study procedure.   "
35507|NCT02821013|"     The purpose of this study is to compare the effects on patients with metastatic melanoma of     taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same     type of agent continuously. Researchers want to see if the two ways of giving this type of     treatment work equally well in extending the life of patients with melanoma, or not.   "
35508|NCT02821000|"     The purpose of this study is to determine the safety, tolerability, and overall response rate     (ORR) of pembrolizumab (MK-3475) in Chinese participants with locally advanced or metastatic     melanoma, with disease progression following first line chemotherapy or targeted therapy. ORR     will be based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The     primary hypothesis is that ORR per RECIST 1.1 by central independent radiology review is     greater than ORR from historical control (10%).   "
35509|NCT02820987|"     This study evaluates PK/PD of an extended-infusion protocol of meropenem,     piperacillin-tazobactam and cefepime, in the early phase of septic shock.   "
35510|NCT02820974|"     There lacks effective early screen system for the migraine-susceptible women during the     peri-menopause period. The processing of acute pain and cognition as well as the underling     functional magnetic resonance imaging (fMRI) features are suitable for screening     pain-susceptible individual. However, there is no study on this issue among the large sample     peri-menopause women. The investigators thus designed the current trial to investigate the     processing of acute pain and cognition as well as the underling featured functional magnetic     resonance imaging (fMRI).The investigators will combine pain behavior,cognitive task, fMRI     analysis, psychophysiological interaction (PPI) and suitable statistical package to     investigate the relationship between the above mentioned features and the occurrence of     migraine and then test the efficacy of these features in predicting migraine development. The     investigators will then try to establish the screening system for migraine-susceptible     individuals in peri-menopause women.   "
35539|NCT02820597|"     This pilot study is a single arm study designed to evaluate the feasibility of cryoablation     in the nasal passageway using the ClariFix Device, to reduce the symptoms of chronic     rhinitis.   "
35572|NCT02820168|"     The purpose of this study is to create a human-readable and executable computer language to     implement medical prescriptions and to evaluate and refine this language, with the goal of     improving safety and efficacy of patient care.   "
35511|NCT02820961|"     The purpose of this study is to determine the effect of exemestane on the pharmacokinetics     (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in     patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer.     Additionally, this study will evaluate the safety and tolerability of entinostat in     combination with exemestane, and assess the effectiveness of entinostat in combination with     exemestane in terms of best overall response and overall survival.   "
35512|NCT02820948|"     A prospective, randomized study was performed. The patients were randomized into 2 groups:     those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those     patients who not (Group 2).      Incisional surgical site infection (SSI), microbiological cultures from the infected surgical     wounds, postoperative pain and acute phase reactants were investigated.   "
35513|NCT02820935|"     This is a two-part study to be conducted at a single study site in the US. Both parts of the     study may be conducted in parallel.      A total of approximately 38 subjects will participate in this study, with approximately 19     subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate     in one of the parts.   "
35514|NCT02820922|"     The aim of this retrospective study is to evaluate the preferred anaesthesia techniques in     our clinic for emergency orthopedic surgery at a 1 year period.   "
35515|NCT02820909|"     The femoral approach is the preferred vascular access for the set-up of emergency catheters     in severely traumatized patient. This location combines simplicity and speed of installation,     it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few     complications and failures.      The ultrasound guidance has greatly reduced installation times, failures and complications     related to the set-up of central venous catheter. This was amply demonstrated in the internal     jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011,     Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the     set-up of arterial and venous catheters in the femoral emergency has not been evaluated in     terms of reduction in complications.      Then the main objective of this study is to demonstrate that the ultrasound guidance reduces     early complications related to the set-up of arterial and venous catheters in the femoral     emergency, among severely traumatized patient compared to the reference anatomical technique.   "
35518|NCT02820870|"     The investigators are trying to understand the impact of the new VA/DoD cholesterol     guidelines on primary care clinics and what the VA or the clinic could do to help clinicians     and teamlets improve their statin use. To do this, the investigators will talk to providers     about these guidelines and perform a brief intervention to help providers meet the     guidelines' recommendations.   "
39693|NCT02766062|"     The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the     effects of early postoperative cognitive function in elderly patients with metabolic     syndrome.   "
35519|NCT02820857|"     Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive     neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and     digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs.      Recent data on the initial presentation of GEP-NEC have been reported in two retrospective     studies and a French cohort study. No standard second-line treatment has been defined for     NECs. Despite a very negative prognosis, these NECs have a certain amount of     chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri,     or Folfox, or single drug treatments such as temozolomide are the proposed options but with a     low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising     results in well differentiated neuroendocrine tumors (NET), known for being hypervascular.     The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the     context of a phase II study. Its combination with Folfiri is efficient and well tolerated in     metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an     optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies     have reported results for these patients, and no on-going phase II or III trial have been     identified to date.      The main objective of this study is to show that, after the failure of a first-line     chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant     prolongation of overall survival in adult patients with GEP-NEC.   "
35520|NCT02820844|"     GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of     overactive bladder (OAB) in several countries, however, it has not been approved for OAB     treatment in Japan. This study has been planned to evaluate the efficacy and safety of     GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been     adequately managed with other medications for OAB.      The primary objective of this study is to evaluate the superiority of a single dose treatment     of GSK1358820 100 units (U) compared with placebo.      The study comprises a screening phase up to 28 days, followed by a double-blind treatment     phase of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820     100 U injection or Placebo injection, in a ratio of 1:1, with further stratification within     the treatment arms according to the number of urinary urge incontinence episodes during     screening. Subjects meeting the criteria for re-treatment will receive a second and third     treatment. Each re-treatment will be with open-label GSK1358820 100 U injection, and will be     spaced at least 12 weeks from the previous treatment.      The total duration of participation for any subject will not exceed 52 weeks, including     screening and the 48-week treatment period.   "
35521|NCT02820831|"     A prospective observational cohort study to assess the predictive value of preoperative     frailty on postoperative quality of life in peripheral vascular surgery patients.   "
35522|NCT02820818|"     Preterm birth alters the normal sequence of lung development with lasting respiratory     consequences. It is still unclear whether observed respiratory morbidities in preterm born     individuals reflect sequelae from a non-progressive lung disease that occurred early in life     or result from ongoing active disease that, if left undiagnosed and untreated, could increase     the risk of a COPD-like phenotype. We propose to examine micro-structural abnormalities of     the lung using innovative non-invasive imaging technologies in relation to pulmonary function     and markers of inflammation and oxidative stress in young adults born preterm.   "
35523|NCT02820805|"     The purpose of this study is to determine the effect of carbohydrates on blood glucose     levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight     (NW) and overweight or obese (OW/OB) children.   "
35524|NCT02820792|"     The LMA ProtectorTM is a new extraglottic airway device which brings together features of     both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate     ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM     (single use - prevention of disease transmission). In the following randomized study the     investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,     fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and     the Ambu AuraGainTM in paralyzed, anesthetized patients.   "
35525|NCT02820779|"     The purpose of this study is to evaluate the effectiveness, long-term safety and explore the     safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.   "
35526|NCT02820766|"     The primary objective of the study is to determine how the short-term outcome of subjects     implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with     other PS total knee systems, and to determine if there is a difference in health care     resources consumed that may result in economic savings to patients, the facility and/or the     payer.      To address the study objectives, patient self-assessment questionnaires, and other objective     measures of post-operative function and health care resource utilization will be used for     data collection.   "
35527|NCT02820753|"     This study will leverage available technologies and test strategies to impart the Universal     Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely     use, and adhere to their complex medication regimens.   "
35529|NCT02820727|"     This study addresses the influence of anesthesia induction, ventilation and influence of     cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function.     Influence on patient outcome is also studied. Three dimensional echocardiography is applied.   "
35530|NCT02820714|"     The objective of this study is to evaluate BLI801 laxative in adults experiencing     non-idiopathic constipation.   "
35531|NCT02820701|"     This prospective, randomized, controlled trial is proposed to investigate the effect of OMT     on sacral base asymmetry as assessed by ultrasound.   "
35532|NCT02820688|"     This prospective, randomized, double blind study aims to determine the optimal volume for     adequate sensorial and motor blockade following an infraclavicular block. Patients will be     randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine     180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL,     second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor     block will be compared for patients between groups   "
35533|NCT02820675|"     The German Quality Network Sepsis is an association trying to improve quality of care for     patients with sepsis, severe sepsis and septic shock or being in risc thereof.      The icosmos trial investigates the impact on the use of routine data, a risk adjustment     algorithm and feedback to all hospitals as well as a structured implementation for regular     screening for deteriorating patients, and education on in-hospital mortality.   "
35534|NCT02820662|"     The development of the retinal vascular network is generally complete during the 3rd     trimester of pregnancy but may continue during the first 15 days of life. This late     maturation may cause problems in pre-term births and may result in immature vascularization     of the retina, a condition called retinopathy of prematurity. Among the different factors     affecting the development of the retinal vasculature, the tissue level of omega-3     polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the     PUFA present in the tissues (nature of the phospholipids in their membranes). This project     aims to show a possible association between levels of omega-3 PUFA and the onset of     retinopathy of prematurity (ROP).   "
35535|NCT02820649|"     Rationale. Sleep loss is a risk factor for cardiovascular events mediated through endothelial     dysfunction.      Objective. To determine if 7 weeks of exercise training can limit cardiovascular dysfunction     induced by total sleep deprivation (TSD) in healthy young men.      Methods: 16 subjects will be examined during 40-h TSD, both before and after 7 weeks of     interval exercise training. Vasodilatation induced by ACh, insulin and heat (42°C) as well as     pulse wave velocity (PWV), blood pressure and heart rate (HR) will be assessed at baseline,     during TSD, and after one night of sleep recovery. Biomarkers of endothelial activation,     inflammation, and hormones will bemeasured from morning blood samples at 07:00   "
35536|NCT02820636|"     The study is about developing the best aftercare treatment possible for Latino/a adolescents     who have been hospitalized in a psychiatric unit due to a suicidal crisis (suicidal thoughts     or attempts). The treatment's purpose is to help adolescents and their caregivers develop     skills to prevent future suicidal crises. Latino/a adolescents usually report more suicidal     behavior than other ethnic groups. The question that the investigators want to answer is if a     new treatment (socio-cognitive behavioral therapy-(SCBT)) developed to their specific needs,     taking into account their culture and aspects of adolescence, performs better than the     treatment that they usually receive. Fifty adolescents will be recruited from the Bradley     Hospital adolescent inpatient unit or the Hasbro Inpatient Medical & Psychiatric Program, or     referred to Gateway Healthcare after discharge from other inpatient units in Rhode Island;     half of them will be assigned randomly to the treatment they would usually receive (TAU) and     the other half to the new treatment (SCBT). In both groups, caregivers and adolescents will     have to complete questionnaires and interviews before the beginning of treatment and at 3, 6,     and 12 months after the treatment begin. Questions to the participants will be related to     their presenting symptoms, family, social group, problems, and other similar topics. Also,     participants will be asked about their satisfaction with the treatment they are receiving.     The purpose of the questionnaires and interviews are to follow their progress in therapy. At     the end, comparisons will be made between the group who participated in TAU and the group who     participated in the SCBT, based on the assessment results from the adolescents and     caregivers.   "
35537|NCT02820623|"     The objective is to compare the accuracy, costs, and cost-effectiveness of three fidelity     measurement methods to assess fidelity to cognitive-behavioral therapy for youth. The     investigators will randomize 135 therapists, implementing cognitive-behavioral therapy, to 3     conditions: self-report, chart stimulated recall, and behavioral rehearsal (N = 45 for each     group). To calculate the outcomes of interest, each condition will be compared to the     gold-standard fidelity measurement method, direct observation.   "
35538|NCT02820610|"     It is important to keep children undergoing laparoscopic surgery pain free.   "
35540|NCT02820584|"     Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20     patients (in order to achieve 12 valuable patients). The expected accrual time would range     between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring     will end two years after the initial surgery of the last patient enrolled. The primary     objective will be to assess the activity of immunotherapy in terms of its effect on immune     response. In particular we will investigate the effect of treatment on effector cells     including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12     eligible patients was identified on ethical and practical considerations, rather than by a     formal sample size calculation.   "
35541|NCT02820571|"     The OPAL study is about health outcomes in older adults. The investigators are surveying     4,000 adults across England to see how health and physical activity change over time. The     information that is collected will help the investigators to understand how a person's     health, including conditions such as back pain, affect their mobility as they age, and     provide insight into improving the management of health in older adults.   "
35542|NCT02820558|"     This study evaluates the delivery of substance P via the celiac artery in the treatment of     recent onset type 1 diabetes.   "
35543|NCT02820545|"     The study aims to construct and validate a self-administrated questionnaire to assess the     patients' perception of patient safety in surgical care units. The originality of the study     is to perform sociological interviews of hospitalized patients to assess their own perception     on the safety of their care and to create corresponding items which will be included in a new     questionnaire. In a second step, patients' perception of patient safety will be assessed in     numerous surgical care units in France, in order to analyze the psychometric properties of     the questionnaire and consequently to validate the questionnaire. The patients' perception     will be compared to the healthcare professionals' perception on patient safety and to the     patient safety strategies in place in the care units.   "
35544|NCT02820532|"     Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate     for this uncertainty. However it is not known if the couch motion influences the respiratory     pattern of the patients. This will be evaluated in this study on healthy volunteers.   "
35545|NCT02820519|"     Loxapine is an antipsychotic drug approved for the treatment of schizophrenia in several     countries including the United States. In animal studies in mice, loxapine reduced     neuropathic pain. Hence, in a proof-of-principle and dose-escalating study the tolerability     and analgesic efficacy of loxapine will be evaluated in patients with neuropathic pain.   "
35546|NCT02820506|"     The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in     combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and     in patients with cervical cancer tumour size 2-4 cm.   "
35547|NCT02820493|"     Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and     Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical     practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy     is limited. Based on these concepts, a new drug has been developed for IBD treatment.     Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut     lymphocyte trafficking.      The hypothesis of this study is that VDZ therapy may be to halt CD disease progression during     time and modifying its natural history, using Lemann Index.   "
35548|NCT02820480|"     Rehab in a Crate is a therapy gym designed to be affordable, compact and easily     transportable. The purpose of this particular study is to gain feedback on the initial design     of the Rehab in a Crate system. This will be accomplished by using qualitative ethnographic     research methods (i.e. human centered design) in the form of surveys that have been carefully     designed by members of the research team. The eligibility criteria of this survey research     reflects the intended user base of an eventual finished product, which is survivors of stroke     and cerebral palsy across the globe. And while healthcare professionals are not the user base     per se, their expertise and feedback should be instrumental in the design of future     iterations of the Rehab in a Crate. Ease of use, utility, design, and various features, both     existing and intended, will all be surveyed items.   "
35549|NCT02820467|"     Investigators conduct a monocentric pilot study with the objective to determine the     hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best     correlated with toe pressure in patients with suspicion of critical limb ischemia.   "
35550|NCT02820454|"     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. AGuIX particles     may increase the effectiveness of radiation therapy by making tumor cells more sensitive to     radiation.      PURPOSE: This first-in-man Phase I trial will study the side effects and best dose of AGuIX     when injected together with whole brain radiation therapy in treating patients with multiple     brain metastases. The effectiveness of the combination of AGuIX and radiation therapy will be     also assessed.   "
35551|NCT02820441|"     The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with     14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.   "
35552|NCT02820428|"     Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in     Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment     and must be considered in treatment policies.      Due to their specificity and the absence of an appropriate evaluation tool, behavioral     disorders are rarely searched for.      Therefore, investigators developed a scale permitting qualitative and quantitative evaluation     of behavior according to the severity of the disorders.      This study aims to define reference values for healthy individuals   "
35553|NCT02820415|"     Oocyte accumulation by vitrification is a valid strategy to increase the number of available     embryos for biopsy and the number of viable euploid embryos to transfer after preimplantation     genetic testing.   "
35554|NCT02820402|"     Project Viva is a prospective cohort study of maternal and child health, following over 2,000     mother-child pairs from the mother's pregnancy into the child's adolescence.   "
35555|NCT02820389|"     This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for     patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS     costs and waiting times whilst increasing patient satisfaction compared to clinical practice     with utilisation of Optical Colonoscopy.   "
35559|NCT02820337|"     The main goal of our project is the study of subcutaneous and visceral (SAT and VAT) adipose     tissue taken during bariatric surgery (Single port sleeve gastrectomy) of subjects with HIV     infection, anf morbid obesity with undetectable viral load (VL) and having HIV     lipohypertrophy particularly truncal. The study covers both the morphology of     adipocytes,fibrosis, immune activation and inflammation, gene expression, pharmacology of     antiretroviral drugs (ARV) and the measurement of viral replication in the adipose tissue and     the plasma before and after bariatric surgery.   "
35560|NCT02820324|"     The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine     administered as needed (PRN) compared with placebo in patients with moderate to severe acute     pain after abdominoplasty.   "
35561|NCT02820311|"     The purpose of this study is to evaluate if TD-4208, an investigational drug being developed     to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the     electrical activity of the heart.   "
35562|NCT02820298|"     The purpose of this study is to investigate the effect of a high-fat meal on the levels of     bexagliflozin in the blood in healthy subjects.   "
35607|NCT02819713|"     This is a randomized controlled trial. One group (intervention group) will get in advance to     the prostate biopsy rectal approximately 5 cc Instillagel. And one group (control group) will     get in advance to the ultrasound -guided prostate biopsy rectal gel. Pain is measured using     the Numerical Rating Scale (NRS). The NRS is an imaginary line from 0 until 10. The 0 is no     pain and 10 is most worst imaginable pain.   "
35563|NCT02820285|"     Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its     strong increase in the last 20 years. Among the many complications associated with obesity,     liver complications (steatosis and steatohepatitis [NASH]) are among the most common.     Semaphorins were described in the early 1990. More than 20 types of these proteins have been     reported to date. These proteins were used for neural development. Since many functions have     also been described. The semaphorins are involved in numerous physiological or     physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the     regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that     dendritic cells infiltrate adipose tissue and initiate the activation of T cells and     inflammation. Immune semaphorin are new players in the regulation of inflammation and immune     reactions.      The role of immune semaphorin in regulating inflammation in the two compartments (liver and     adipose tissue) could be a crucial step that could lead to more severe liver damage. Its     dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation     of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic     markers or future therapeutic targets.   "
35564|NCT02820272|"     Negative pressure wound therapy (NPWT) is a technique using vacuum dressing to promote wound     healing in complicated wound. However for many patients, the application and removal of the     NPWT is source of procedural pain. Some techniques had been reported to reduce these pain     such as administering topical lidocain or normal saline solution before the dressing change.     The authors hypothesized that administering cold water into the NPWT sponge would decrease     pain during dressing changes.   "
35565|NCT02820259|"     The purpose of this study is to demonstrate that the biliary concentration of TCR is a good     marker of its immunosuppressive activity.   "
35566|NCT02820246|"     Malnutrition at hospital admission is a risk factor for an unfavourable outcome, prolonged     hospital stay and delayed recovery. In these patients the incidence of complications such as     nosocomial infections, poor ventilatory function, prolonged bed rest is increased. In     addition a relevant proportion of patients have a nutritional intake below their needs during     hospitalisation.Mortality has been shown to be up to 8 times higher and dependency at     discharge up to 3 times more frequent when actual food intake was below 25% of calculated     needs.      The aim of this international cross-sectional multicentre audit and registry is to generate a     risk and level of nutritional intervention profile for an individual unit/ward based on     case-mix, nutrition care and available structures. This profile should give a snapshot on the     relation of risk to resource allocation. The audit is unit centered. Each unit get as a     feedback anonymously its position compared with all other participating units. Risk     adjustment for selected patient groups, social environments and structures is planned.      In conclusion this audit/registry will serve five distinct aims:        -  Generate a precise map of the prevalence of malnutrition before admission and of          decreased nutrient intake according to risk factors, medical specialty, organisational          structures and countries.        -  Increase in awareness for clinical nutrition in patients, caregiver and hospital          managers.        -  Enlarge and maintain a reference database for hospitalised patients        -  Provide individual unit benchmarking   "
35567|NCT02820233|"     This study examines the role of the epidermal growth factor (EGF) receptor family and the EGF     family of ligands in the regulation of non-myocytes isolated from the human heart.   "
35568|NCT02820220|"     Observational, cross sectional study, carried out with the help of a pre-designed and     pre-tested questionnaire with the research hypothesis as: Knowledge and perception regarding     JSSK and RBSK in nursing students is better as compared to in-service nurses as well as     patients/patient attendants (attending LHMC and associated hospitals, New Delhi, India)   "
35569|NCT02820207|"     OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk     factors for unstable carotid plaque. This study was designed to evaluate whether carotid     intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced     ultrasound (CEUS).      METHODS: Preoperative CEUS analysis of 50 carotid artery stenosis patients would be compared     to histopathology performed on their plaques excised by carotid endarterectomy (CEA) with     CD34 and MMP9 staining.   "
35570|NCT02820194|"     The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT     by means of a randomised, controlled trial in patients affected by inoperable colorectal     liver metastases. The chosen comparator is MWA.      The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term     outcomes.   "
35573|NCT02820155|"     This is a double-blind, randomized, placebo-controlled, dose-escalating, single dose and     multiple dose study.   "
40894|NCT02750345|"     The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1)     and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are     bioequivalent to the reference product Orfadin 10 mg hard capsules.   "
35574|NCT02820142|"     The incidence of acute kidney injury (AKI) among all hospitalized patients is approximately     7%. Among these patients, sepsis and septic shock remain the most important cause of acute     renal failure (ARF) and account for more than 50% of cases of AKI. The goal of this project     is to uncover key factors that lead to renal function recovery. This study is planned to     survey novel biomarkers that reflect tissue pathology or regeneration. During the     hospitalization, blood and urine sample will be collected for NGAL and inflammatory marker     analysis in the patients with bacteremia, while the rest sample will be collected for further     novel biomarker survey. This study is to early predict the renal function impairment and     identify the possible molecule that involved in renal function recovery.   "
35575|NCT02820129|"     This study evaluates whether or not the use of a medication wallet card in patients over 70     taking 5 or more medications promotes self-efficacy with regards to coping with illness,     understanding medications, and staying healthy. Half of the participants will receive an     individualized medication wallet card with their medications and medical conditions listed     while the other half will receive a simple reminder card.   "
35576|NCT02820116|"     This is an open-label, multicenter, single-arm, phase II interventional clinical trial     evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA-     IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Sixty-seven resectable stage IIIA-     IIIB NSCLC patients with EGFR activating (19/21) mutations will be eligible to be enrolled.     EGFR mutation will be prospectively tested in all the participants' biopsy samples and     confirmed in surgical resected samples.      Neoadjuvant treatment phase:      Eligible patients will receive 125mg of Icotinib three times per day. Treatment will be     scheduled to continue until the disease progression or unbearable toxicities appear.      Surgery treatment phase:      Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The     patients with responsive disease considered to be technique resectable will undergo     resection.      Post-surgery phase:      It is the discretion of the investigator whether the patient is a candidate for     post-operative treatment which is considered to be in the best interest of the patients. It     is recommended that patients with positive margins or residual tumor after surgery should     receive radiation therapy. Patients after surgery will receive long-term follow-up -- chest     CT scan，abdominal abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan     (ECT) every 12 months -- for up to 5 years.   "
35577|NCT02820103|"     1. To test the effectiveness of the theory-based interventions (text+visual and text-only          BCT-based interventions) against usual care in changing patients' intentions to phone          ambulance immediately with symptoms of ACS ≥ 15 minutes duration.        2. To determine the most effective mode of delivery by comparing the text+visual BCT-based          intervention with text-only BCT-based intervention.        3. To investigate any unintended consequences of the intervention on intentions to phone an          ambulance for non-life-threatening symptoms.   "
35578|NCT02820090|"     Infection and trauma take a important role in the acute respiratory failure.There are     different causes and degrees of inflammatory reaction in the critically ill patient. The     inflammatory reaction should also affect patients on mechanical ventilation dependence with     body physiological response and disease prognosis in patients. Therefore, the investigators     hypothesize that inflammation may have an important role in the prediction of weaning from     mechanical ventilation.   "
35579|NCT02820077|"     This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of     bleeding from malignant lesions of the upper GI tract. Half of participants will receive     hemostatic powder and half will be submitted to standard treatment.   "
35580|NCT02820064|"     Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic systemic hypoxia and     low-grade inflammation as well as by an alteration of arginine (ARG) metabolism. As ARG is     synthetized from circulating citrulline (CIT), an alteration of CIT homeostasis, particularly     its production by ornithine transcarbamylase (OCT) in small intestine could be involved. We     hypothesized that hypoxia +/- inflammation, classically associated to COPD, has effects on     OCT regulation in enterocytes.      This study aims at exploring the effects of hypoxia and inflammation on the production of     citrulline by ornithine transcarbamylase (OTC) activity in enterocytes from explant cultures     of duodenal tissue.   "
35581|NCT02820051|"     Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of     respiratory diseases. Although midazolam is the recommended sedative agent by most     guidelines, propofol has gained popularity due a short recovery time, however, evidence to     propofol use for sedation during FB is scarce. There is little evidence about transcutaneous     CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered     by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough     inhibition.      The investigators performed a randomized controlled trial to determine whether     non-anesthesiology-administered balanced-sedation with propofol was related to high values of     values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The     investigators included data from outpatients 18 years or older with an indication for FB in a     university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient     satisfaction and adverse effects.   "
35582|NCT02820038|"     The aim of the proposed project is to compare the effectiveness of two strategies designed to     enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated     for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed     by Woloshin and Schwartz to enhance the usability of consumer medication information. The     investigators will also assess whether the effectiveness of these communication strategies     can be increased by Gist Reasoning Training, which is designed to enhance patients' ability     to extract meaningful gist from complex information.The investigators anticipate enrolling     300 individuals with rheumatoid arthritis. The study will use a randomized controlled trial     design with four study arms. Data will be collected primarily via self-administered,     Internet-based surveys using REDCap. All participants will be followed for 6 months after the     completion of baseline data collection.   "
35583|NCT02820025|"     The current study is designed to investigate the difference of plasma orexin A levels between     doxapram group and controlled group at emergence time from sevoflurane-remifentanil     anesthesia who will undergo elective lumbar surgery.   "
40895|NCT02750332|"     The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone     10 mg Tablet, under fasting and fed conditions (food-effect).   "
35584|NCT02820012|"     Although practiced for many years, surgical correction of scoliosis is relatively subject     published for idiopathic scoliosis and a few published for other types of scoliosis.      This study involves a creation of an observatory of patients undergoing scoliosis by ST2R     reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system.      The main objective is to analyze the three-dimensional correction of the deformity after     intervention and its maintenance over time depending on the etiology of scoliosis.      This research is conducted in pediatric surgery services specialized in this technique.      Correcting radiographic parameters is directly related to the surgical procedure. The quality     of life of patients is indirectly affected by the surgery. Secondary objectives are to     analyze the surgical technique and to evaluate its impact on the quality of life of patients.      This study will firstly to have a better understanding in:        -  Scoliosis of the children and adolescents and their surgical treatment;        -  The impact of the surgical procedure by the ST2R technique on the three-dimensional          correction, and the patient's quality of life; and secondly, better management of          patients requiring surgery for scoliosis as well as a public health impact.   "
35585|NCT02819999|"     The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline     treatment of small cell lung cancer (SCLC).   "
35586|NCT02819986|"     The purpose of the present study is to determine the effectiveness and feasibility of the     Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders.     PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help     individuals return to life roles including readiness to return to work. PGAP has been shown     to be effective with some chronic health conditions however has not been specifically studied     in mental health populations. The study consists of 10 one hour weekly therapy sessions that     focus on reducing psychosocial risk factors that result in disability through the use of goal     setting, activity planning and activation, monitoring and challenging thoughts about return     to work, and problem solving. Participants will also be asked to complete short self-report     questionnaires as well as a semi-structured interview about the participants anxiety, mood,     impact of disability, and current functioning at the beginning of session one and within two     weeks after session 10. Two short questionnaires will also be completed at each session     measuring the degree to which the participants daily life impacts and is affected by anxiety     or mood symptoms.   "
35587|NCT02819973|"     VIVID is a prospective, multicenter, randomized clinical trial that will evaluate three     specific research questions. In black patients eligible for a primary prevention implantable     cardioverter defibrillator (ICD), 1) what is the effect of a patient-centered educational     video compared with usual care (UC) on knowledge of SCD (Sudden Cardiac Death), associated     risk factors, and ICDs; 2) what is the effect of a patient-centered educational video     compared with UC on the decision for ICD implantation, decisional conflict, and receipt of an     ICD within 90 days of the decision; 3) what is the effect of racial concordance between study     patients and video participants (health care providers/patients) on the decision for ICD     implantation, decisional conflict and ICD receipt within 90 days of the decision. In     addition, in-depth qualitative interviews (IQI) with a sample of trial participants will be     conducted to determine the salient influences on their decision and explore the reasons for     their ultimate decision and subsequent implantation or non-implantation of an ICD.      Approximately 480 patients eligible for a primary prevention ICD will be enrolled at     approximately 12 hospitals in this study. Study sites selected for VIVID will be     geographically diverse and provide care to a significant proportion of racial and ethnic     minority patients. Patient's will be mailed a letter, regarding the study, prior to their     initial visit. At the initial visit, patients will be approached about participation in the     trial. For those interested, informed consent will be obtained and patients will be     randomized. The investigators will be utilizing electronic consents on an iPad. Black     patients will be randomized to one of 3 arms: educational videos presented in the same     format; one with black participants (patients and providers) or the other with white     participants (patients and providers); The third arm will be usual care (control) and the     provider can interact with the patient consistent with their typical/usual care. Notably, for     both intervention and control arms, all patient management decisions are completely at the     discretion of the care providers.   "
35588|NCT02819960|"     Diarrhea is a relatively common complication in patients with cancer. At its inception,     several mechanisms participated; malabsorption on the basis of mucositis induced by     chemotherapy, dysbiosis induced by broad-spectrum antibiotics and predisposition to     infectious diarrhea in immunocompromised patients. Some cytostatics and their metabolites can     also induce diarrhea directly due to effect on the intestinal mucosa.      Use of probiotics in prevention and treatment of diarrhea relies on both the theoretical     assumptions and the results of several clinical trials. Lactic acid bacteria involved in the     treatment of dysbiosis, compete for substrate with pathogenic bacteria, produce     bacterio-cins, increase transepithelial resistance. Their enzymatic activity affects     activation or deactivation of metabolites which cause diarrhea. Production of short chain     fatty acids, which are important for the maintenance of intestinal mucosal cells also     contributes to their antidiarrhoeal effect.      This randomized, double-blind, placebo controlled, multicentre trial was designed to evaluate     potential of probiotics to prevent grade 3-4 diarrhea in patients treated by irinotecan based     chemotherapy during first 6 weeks of irinotecan based chemotherapy   "
35589|NCT02819947|"     To establish a new prospective cohort of Korean patients with systemic sclerosis and track     the natural history of the disease over time.      To generate new hypotheses for further investigation.   "
35590|NCT02819934|"     A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male     Subjects   "
35591|NCT02819921|"     This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The     purpose of this study is to determine if desvenlafaxine was effective in decreasing the     frequency and severity of hot flashes in breast cancer patients taking tamoxifen.   "
35592|NCT02819908|"     To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular     solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first     week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).      The hypothesis is that the dropless regimen will be non-inferior to the less drops     regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.   "
35593|NCT02819895|"     The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a     customized automated telephone and email immunization reminder system will be feasible,     acceptable, and significantly improve immunization utilization rates.   "
35594|NCT02819882|"     This study is a prospective, multicenter non-interventional cohort study designed to develop     a registry in unresectable locally advanced or metastatic disease.   "
35595|NCT02819869|"     The study demonstrated that either statin or metformin served as notable use in reducing the     incidence of many cancers.   "
40961|NCT02749474|"     The objective of this study is to follow the treatment options offered to pregnant women     diagnosed with cancer and study the impact that their treatment or delay of treatment has on     their own health and that of their children.   "
35596|NCT02819856|"     The primary objective of this study is to determine the safety and tolerability of SPI-1005     treatment in CF patients with active pulmonary exacerbation that are receiving an IV course     of tobramycin, using histories, physical exams, vital signs (VS), adverse event (AE)     reporting, hematology (CBC) chemistry (Chem-20).      The secondary objectives of this study are to determine the pharmacokinetics of oral SPI-1005     at 200, 400 and 600 mg BID for 21 days. Peak/trough assessments will be determined for     ebselen, its major metabolite and selenium. Clinical assessments of the severity of     sensorineural hearing loss, speech discrimination, vertigo severity, tinnitus severity and     lung function will be made compared between treatment arms and the placebo arm of this study.   "
35597|NCT02819843|"     The purpose of this phase II clinical study is to test the good and bad effects of T-VEC     (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with     melanoma, Merkel cell carcinoma, or other solid tumors with skin metastasis.   "
35627|NCT02819453|"     It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence     against viral and bacterial stimuli by modulating the immune response. The aim of this study     was to determine IL-18 levels in serum of patients with acute respiratory distress syndrome     and to investigate whether corticosteroid attenuate its levels.   "
40290|NCT02758249|"     Anesthetics agents has an effect on immune response during the cancer surgery.This influence     can regulatory to immune activity or cancer cell survival.      The purpose of this study is to prove the variation of immune cell activity between     preoperative and postoperative period.   "
35598|NCT02819830|"     This study is investigating whether a six-week exercise training programme, designed for     patients with Rheumatoid Arthritis, improves disease activity, inflammation,     cardiorespiratory fitness, muscle strength, flexibility and risk factors for cardiovascular     disease. Twenty four patients will be randomly assigned to an intervention or control group     (n=12 in each group). The intervention group will will undertake a fully supervised     structured exercise training programme, consisting of both aerobic and strength training     exercise, taking the form of two 70-minute group fitness classes per week for six weeks.     These participants will also undertake a 30-minute walk in their own time. The control group     will continue to go about their normal daily activities. Measurements will be made before and     after the intervention/control period, including assessments of disease activity (e.g., by     gauging how swollen and tender patients' joints are using the Disease Activity Score(DAS) )     and assessments of fitness and/or physical functioning (e.g., 200 meter timed walk test, a     strength test, a flexibility test, Health Assessment Questionnaire Disability Index (HAQDI)).     Blood samples will also be collected from patients before and after the intervention/control     period to measure markers of inflammation, such as C-reactive protein (CRP) and Erythrocyte     Sedimentation Rate (ESR). The investigators will also measure other parameters that are     linked to type II diabetes (e.g., fasting glucose concentration) and factors implicated in     cardiovascular disease risk (e.g., lipid profile and resting blood pressure).   "
35599|NCT02819817|"     This is a double blind placebo-controlled RCT comparing the speed of healing of simple     traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard     care.   "
35600|NCT02819804|"     The purpose of this research study is to determine the acceptable upper limit dose of     nivolumab in combination with dasatinib that may be given to patients with     relapsed/refractory philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).     Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has     not yet been investigated in Ph+ ALL. Dasatinib is currently FDA approved for the treatment     of Ph+ ALL, but has not yet been investigated in combination with nivolumab for this disease.     There is evidence that dasatinib not only blocks the Philadelphia chromosome or breakpoint     cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) mutation, but also     increases the activity of cells in your immune system. Nivolumab increases T cells in your     immune system, which allows your immune system to attack the cancer. We think the combination     of these drugs will be more effective against your leukemia than either drug used alone.   "
35601|NCT02819791|"     The Exploration Center for Prevention and Treatment of Atherosclerosis (CEPTA, Bordeaux     Hospital University) showed that following myocardial infarct (MI) or ischemic stroke (TIA or     stroke), the global management (medical and educational) of patients led to very long-term     satisfactory results in terms of reduction of cardiovascular (CV) risk and morbidity and     mortality. However, the specific effect of therapeutic education beyond the conventional     treatment has never been an adequate assessment. The following at 1 year of this study will     show the evolution of chronic long-term CV disease in patients who received therapeutic     education, and to explain the mechanisms. The challenge of this project is to demonstrate for     the first time the superiority of therapeutic education and conventional care and propose a     modeling program for national diffusion.      Patients who experienced a CV event (MI, stroke) will be randomized into 2 groups of 165     patients each: 1) receiving conventional treatment alone; 2) receiving conventional treatment     + CEPTA program. The study was built for a 1-year follow-up period, to demonstrate the impact     of therapeutic education on evolution of risk factors, physical, psychological and social     health of patients. The main benefit of this study for the patient is the implementation of     an optimized treatment and long-term monitoring by a cardiology referral center.   "
35602|NCT02819778|"     Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric     emergency departments. So as not to overlook the risk of complications, which occur at a rate     of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient     observation are prescribed. Ultimately, the majority of these measures could be avoided and a     large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children     who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as     the S100B protein, has the potential to reduce the number of these unnecessary measures.   "
35603|NCT02819765|"     This study aims to establish a biorepository and phenotyping database to investigate     longitudinal changes in ALS subjects. Blood, including DNA and RNA, cerebrospinal fluid (CSF)     and electrophysiologic measures will be collected every 3 months over 1 year. The database     and specimen repository will be made available to ALS researchers on a merit basis.   "
47877|NCT02658942|"     to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL)     compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal     stones (LC) stones.   "
35604|NCT02819752|"     This study aims to establish whether the combination of pembrolizumab (MK-3475) and     conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels     of acute and late toxicity in patients with stage IV LA-SCCHN. In particular, the study will     provide data on the levels of mucosal and cutaneous toxicity within the radiation fields, as     these are the primary acute toxicities associated with this treatment regimen. In addition,     toxicity outside the radiation portals (which may theoretically be exacerbated by radiation)     will be studied. However, all toxicity will be monitored. This study will also give an     indication of the activity of pembrolizumab in LA-SCCHN because we are deliberately selecting     a group of patients with high- and intermediate-risk disease who have a significant chance of     experiencing loco-regional or systemic failure.   "
35605|NCT02819739|"     The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass     by his heart preconditioning effect is associated with a lower incidence of cardiac     arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of     myocardial ischemia-reperfusion injury in cardiac surgery postoperative.   "
35606|NCT02819726|"     This is a multicenter, randomized, double-blind, parallel group study to compare the PK, PD,     safety, efficacy, tolerability, and immunogenicity of SAIT101 versus MabThera® versus     Rituxan® in patients with RA. This study will take place globally across approximately 70     study centers in order to randomize approximately 282 patients. The study consists of Part A     from baseline for PK and efficacy analysis, followed by Part B from Week 24 to 52 for safety     follow-up that also collects transition data.   "
35608|NCT02819700|"     Behavioural disorders are very common right from the initial stage of dementia and contribute     to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their     prevalence and their diagnostic importance, as they often constitute the initial symptoms of     Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they     are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD).     The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been     partially evaluated and would increase the risk of progression to dementia. These classical     data are based on non-standardized assessments and non-validated diagnostic criteria. The     Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a     standardized assessment tool for behavioural dysexecutive disorders, the Behavioural     Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this     syndrome.   "
35609|NCT02819687|"     A Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the     safety, tolerability, pharmacokinetics, and pharmacodynamics of single-and multiple-ascending     doses of RDX5791 in healthy male and female subjects.   "
35610|NCT02819674|"     Hypertension (HTN) is the most important cardiovascular risk factor which is responsible for     50% of cardiovascular morbidity and mortality, and also a substantial public health problem     affecting approximately 1/4 of the adult population in industrialized societies and over 1     billion people worldwide. Chronically elevated blood pressure without well control puts     people at increased risk of target organ damages, including stroke, myocardial infarction,     congestive heart failure, end-stage renal disease, blindness, and death. Especially, these     damages are dramatically more severe in the early-onset hypertensive population.   "
35611|NCT02819661|"     The study will examine whether there is a difference in the frequencies of respiratory     depression among obese women receiving spinal anesthesia combined with opioids compared to     women with normal BMI.      If such a risk exists further investigation will be required to establish the proper criteria     for the administration of morphine with spinal anesthesia to obese women.   "
35612|NCT02819648|"     The aim of this single-center randomized, double-blind, placebo-controlled clinical trial is     to assess the effect of preoperative, single, oral dose of prednisolone on postoperative pain     and medication intake in patients with symptomatic, irreversible pulpitis in mandibular     molars.   "
35613|NCT02819635|"     This study comprises three sub-studies. The objective of sub-study 1 is to characterize the     dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical     remission in order to identify the induction dose of ABT-494 for further evaluation in     sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494     compared to placebo in inducing clinical remission in participants. The objective of     sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in     achieving clinical remission in participants who had a response following induction with     ABT-494.   "
35614|NCT02819622|"     Purpose: Central serous retinopathy (CSCR) is characterized by macular detachment due to     thickened choroid mostly affecting young men under perceived stress. While most previous     studies in CSCR have been retrospective and have focused on a single facet of the patient's     personality, the investigators conducted a prospective intercontinental controlled study to     analyze the multifaceted personality profile in CSCR.      Design: Prospective interview. Participants and Controls: Subjects with CSCR consented to     participate in a questionnaire. Controls not having retinal disease were recruited from the     same clinic.      Main Outcome Measures: The main parameters registered were presence of stress, daily number     of cups caffeine intake, personality traits (Type A; obsessive-compulsive; aggressive).      Methods: The interview consisted of a 60-item questionnaire. Recruitment of participants was     from January 2015 to February 2016. Controls were matched for age, gender and race.     Statistical analyses were done using univariate and multivariate analysis.   "
35615|NCT02819609|"     The purpose of this observational, retrospective database study of patients with uterine     fibroids is to compare the durability of symptom relief after uterus-conserving treatments     for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and     subsequent procedures and evaluate the effect stakeholder participation had on the research     process.   "
35640|NCT02819284|"     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented     clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2     drops instilled in each eye four times daily (QID).   "
35641|NCT02819271|"     This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy     volunteers.   "
35616|NCT02819596|"     This study is being carried out to see if the drugs MEDI4736, Savolitinib and Tremelimumab     can be used alone or in combination to reduce the size of tumours in patients with kidney     cancer.      The drugs being tested in this study have an anti-tumour effect and have been tested in     pre-clinical and human studies before. MEDI4736 and tremelimumab work with the immune system     to help the body fight against tumour cells with immune cells. Savolitinib works to correct a     faulty signal which causes tumour growth.      If a patient is eligible for the study and decides to take part, they will be enrolled into     one of 3 stages of the study.        -  First stage [CLOSED TO RECRUITMENT]: aims to find the optimal dose of          MEDI4736+savolitinib.        -  Second stage [RECRUITING]: patients with papillary cell cancer will be treated with          MEDI4736+savolitinib. Patients with clear cell cancer will be randomised to one of four          treatment arms and receive MEDI4736, savolitinib, MEDI4736+savolitinib, or          MEDI4736+tremelimumab.        -  Third stage [NOT YET OPEN TO RECRUITMENT]: patients will be tested for biomarkers before          enrolment, and depending on the results will be allocated to one of 3 treatments          (MEDI4736, savolitinib, or MEDI4736+tremelimumab) to see if certain biomarkers are          linked to drug efficacy.   "
35617|NCT02819583|"     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell     immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.   "
35618|NCT02819570|"     The objective of the study is to compare a new antibiotic protocol with the current     prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm     labor, chorioamnionitis and early onset sepsis   "
35619|NCT02819557|"     This is a Phase 2, multiple-dose, open-label study evaluating the safety, and     pharmacokinetics (PK) of ataluren in patients aged ≥2 to <5 years old with Duchenne muscular     dystrophy caused by a nonsense mutation in the dystrophin gene. The study includes a 4-week     screening period, a 4-week study period, and a 48-week extension period for patients who     complete the 4-week study period (52 weeks total treatment).   "
35620|NCT02819544|"     Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy     is characterized by frequent post-operative pain and can decrease the patient's quality of     immediate postoperative life and sometimes the results of decision ambulatory care.      In order to reduce these postoperative pain, various methods have been evaluated in numerous     studies to determine their analgesic role.      As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally     administered in the end of surgery to reduce postoperative pain and promote recovery of the     patient. In addition, it is also possible to instill the anesthetic directly into the     abdominal cavity reducing pain transmitted by nociceptor viscera.      In recent years, new methods have been proposed such as lung recruitment maneuvers and the     instillation of saline solution to reduce postoperative pain.      However, no recommendation is on the use of intraperitoneal saline under the management of     postoperative pain after laparoscopic cholecystectomy in ambulatory care.   "
35621|NCT02819531|"     Design: The proposed study is a randomized study comparing the relative effectiveness of     three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs     using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA) obtained     with IVUS or OCT. Patients will be blinded to treatment assignment for the duration of the     study.      Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL and     subsequent advancement of the RA burr. The RA system is performed using standard technique     under intravenous infusion of heparin. The atherectomy burr size will be determined by the     operator.      Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent     advancement of the OAS according to the manufacturer's guidelines.      Control: Patients who are randomized to SBS will undergo coronary wiring and balloon     inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS     will be used according to the AngioSculpt manufacturer's guidelines.      Duration: 30 days follow-up.      The primary trial objective is to determine which of the three treatment strategies for     treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio     of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT     (primary study endpoint).      The secondary objectives are to compare the following:        1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as          determined by IVUS or OCT (secondary endpoint)        2. Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)        3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined          by quantitative coronary angiography (secondary endpoint)        4. Incidence of major adverse cardiac events (death, myocardial infarction, target vessel          revascularization) during 30 days of follow-up (secondary endpoints)        5. Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)   "
35622|NCT02819518|"     The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in     combination with one of three different chemotherapies will be assessed in the treatment of     locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has     not been previously treated with chemotherapy. In Part 2, the safety and efficacy of     pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of     placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic     TNBC, which has not been previously treated with chemotherapy.      The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs     Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and     in participants with programmed cell death ligand 1 (PD-L1) positive tumors, and prolongs     Overall Survival (OS) compared to placebo and chemotherapy in all participants and in     participants with PD-L1 positive tumors.   "
35623|NCT02819505|"     Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the     extension of physical exercise, counteracting the decline in muscle performance due to     fatigue. However this process is largely restricted by the levels of β-alanine available in     the human body. Carnosine levels can be raised through long term ingestion of food products,     such as meat, fish and poultry, however it can also be significantly increased by β-alanine     supplementation. Improved β-alanine levels can potentially advance exercise capacity and     exercise performance, which may have been previously limited. Recently research has     demonstrated no beneficial effect of β-alanine supplementation on neuromuscular performance     in active, healthy males when they were well rested, with no prior exercise or fatigue of the     assessed muscle. It remains unknown if β-alanine supplementation would aid physical     performance when the muscle has already been fatigued. This is currently being investigated     in older adults (60-80 years), however there is no clear comparison between the potential     effects in younger and older participants.      Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation     on lower limb contractile and force properties, pre and post muscle specific fatigue in 18-30     year old males.   "
35742|NCT02817945|"     This is an open-label positron emission tomography/computed tomography (PET/CT) study to     investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in     lung cancer patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3PTATE-RGD will     be injected intravenously. Visual and semiquantitative method will be used to assess the     PET/CT images.   "
35624|NCT02819492|"     Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it     is mandatory to spend a long enough time investigating the colonic mucosa. A minimum     observation time of 6 minutes has been proposed as a quality criterion for screening     colonoscopy. However, different locations of the colon (proximal, distal) may require     specific observation time periods. The colon can be divided into a proximal (right) and     distal (left) part. Until now, it is unclear whether observation time has a significant     impact on adenoma detection in both parts of the colon. The aim of this study therefore is to     conduct a trial in which side-specific observation times and adenoma detection rates are     measured in order to investigate this correlation in particular for the right colon.   "
35625|NCT02819479|"     To assess the overall safety and efficacy of intra-arterial (IA) bevacizumab for the     treatment of radiation necrosis. A single 2.5 mg/kg dose of bevacizumab will be given     intra-arterially after osmotic blood-brain-barrier disruption.   "
35626|NCT02819466|"     Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence     (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high     morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to     passage of the gastric contents into the unprotected upper airways during general     anaesthesia. The prognosis depends on three factors: the presence of food debris, and the     acidity and volume of the gastric contents. To prevent this complication, the French society     of anaesthesia and intensive care recommends preoperative fasting rules and, in patients     presenting risk factors for aspiration, the use of antacids and rapid sequence intubation.     This preventive strategy is associated with certain adverse events: deferred operative     procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic     complications, and memory of anaesthetic induction.      Over recent years, ultrasound has become more widely used by anaesthetists for local     anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D     ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of     intragastric volume presents several limitations: because of the complex shape of the     stomach, this technique requires a long learning curve and the measured volume is poorly     correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently     measured intragastric volume by three dimensional ultrasound with promising results.   "
35628|NCT02819440|"     Obesity and its adverse cardiometabolic consequences are major public health problems.     Several features of obesity contribute to the associated cardiovascular risk and are     potential targets for intervention. These include insulin resistance and beta cell     dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study     is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic     health in individuals who are obese and insulin resistant.   "
35629|NCT02819427|"     This study, conducted in children with typical or atypical absence epilepsy, will consist     of noninvasive recording of the metabolic activity of the brain concomitantly with     electroencephalographic recording during seizures without the need for any additional     examination. This examination will be performed by combining near-infrared spectroscopy     (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution     (HR) recording.      Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a     functional point of view and is used in the routine follow-up of epileptic children. Optical     imaging is a recent and promising medical imaging technique, which uses near-infrared light.     This rapid, noninvasive and harmless quantitative technique can be easily used at the child's     bedside or in the ward and provides metabolic information on brain functioning.   "
35630|NCT02819414|"     The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate     remains controversial. Currently it is generally accepted to treat only hemodynamically     significant PDAs. The current investigation aims to study the effect of treatment on PDAs of     borderline significance via a prospective, randomized controlled trial of paracetamol in this     group.   "
35631|NCT02819401|"     The present study is designed to determine the gastrointestinal tolerability of enteral     nutritional products, physicians and parents' overall perception of enteral nutrition     products as well as providing basic demographic information on pediatric populations     prescribed these formula for supportive treatment as part of the routine healthcare service     in Turkey.   "
35632|NCT02819388|"     This study evaluates the effects of a community-based counseling intervention to improve     contraception among residents in two deprived neighborhoods in Barcelona (Spain). Half of the     participants received contraceptive counseling at the community setting, while the other half     acted as a control group.   "
35633|NCT02819375|"     Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and     other psychiatric diseases. Currently, most ECT procedures are carried out with muscle     paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic     drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to     establish an accurate balance between adequate anaesthesia depth and optimal seizure     duration.      We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol     with remifentanil and propofol with ketamine), with respect to seizure duration and seizure     quality in patients undergoing electroconvulsive therapy.   "
35634|NCT02819362|"     Benefit of MRI in pathological nipple discharge.   "
35635|NCT02819349|"     The purpose of this study is to examine whether Texting for Relapse Prevention (T4RP), a text     messaging-based early warming for relapse prevention in people who have schizophrenia/SAD, is     associated with fewer relapse symptoms compared to a treatment-as-usual control group.   "
35636|NCT02819336|"     This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture     therapy for the post-stroke patients with urinary incontinence.   "
35637|NCT02819323|"     The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a     PEG based preparation prior to colonoscopy in adolescent patients.   "
35638|NCT02819310|"     The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in     constipated adults.   "
35639|NCT02819297|"     The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and     efficacy versus placebo in constipated adults.   "
35642|NCT02819258|"     Endodontic therapy is to achieve the eviction of the inflamed or infected pulp and fill the     canal opening with a hermetic sealing material.      The analysis of the literature on intracanal therapeutic shows great variability of the     results obtained, the reported success rate is 53 to 95%.      This is explained by the difficulty of the surgical procedure, but also by the multiplicity     of possible factors of failure, related practitioner, canal anatomy, the operating     procedures, the preparation techniques and root canal filling. This success rate is variable     depending on the presence or absence of periapical pathology before treatment: more than 85%     for teeth treated without initial periapical pathology against only 62% for teeth with     pathology before treatment. Furthermore, the literature review revealed two contradictory     assumptions about the dominant factor failure in endodontics: the failure of the sealing     canal system (bad level shutter) against the failure of the endovascular disinfection.      Main hypothesis of the research objectives:      The probability of success in a year endodontic treatments carried out according to the     recommendations and the operating standards on teeth with periapical pathology is     approximately 60%.      The primary prognostic factors would be the existence of intracanal obstacles (stop     calcification ...) responsible for a sub-obturation of the canal, factors inherent to the     tooth (situation ductal anatomy and complexity), the operating techniques used, the     practitioner ( skill level), the quality of the restoration.   "
35643|NCT02819245|"     This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and     try to find how the age will impact the surgical outcome of AIS.   "
35669|NCT02818894|"     Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose     of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a     total hip arthroplasty (THA). The objective of this study is to compare the two spinal     anesthesia treatments in regards to transient neurological symptoms (TNS).   "
35644|NCT02819232|"     Infectious keratitis are favored by the circumstances causing the small trauma of the corneal     epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome     rheumatoid arthritis, or much more frequently wearing contact lenses. If the majority of     infectious keratitis are favourable, some lead to serious injury of the cornea, or even     corneal perforation which result an endophthalmitis. This unfavourable evolution may lead to     blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. This     negative evolution is encountered while the infectious keratitis due to tedious germs of     difficult diagnosis such as nontuberculous Mycobacterial, fungal infections, fungal     keratitis, amoebic keratitis, and certain viral keratitis. The microbiological diagnosis of     routine is based on the systematic search for pathogens tedious from invasive sampling of     cornea by vaccinostyle. We set up a new non-invasive corneal swab diagnostic method.   "
35645|NCT02819219|"     This study will examine the effects of supplemental ElevATP with or without a blend of     extended-release caffeine and B vitamins for changes in body composition, athletic     performance, and hematology over a 12 week intervention period.   "
35646|NCT02819206|"     Our research project is to use a new microbiological diagnostic strategy of uveitis, allowing     detection of the fastidious pathogens of infectious Uveitis who are not diagnosed by     laboratory methods used in diagnostic routine. This new diagnostic strategy is to     automatically detect the presence of a pathogen fastidious in cell culture using the same     patient's serum to reveal a positive culture, based on the assumption that this serum     contains antibodies specific pathogen tedious.      Finally, the main purpose of this study is to improve the etiological diagnosis of Uveitis by     establishing a new diagnostic strategy.   "
35647|NCT02819193|"     Despite the importance of breast milk for sick or preterm neonates, there is currently no     consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of     this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate     the association between early use of raw MOM and breastfeeding continuation at discharge and     up to 6 months later.   "
35648|NCT02819180|"     Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza     vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and     elderly older than 60 years of age.   "
35649|NCT02819167|"     Ischemic strokes are one of the leading causes of handicap and death in elderly people in     France.      Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual     activities and other environmental factors that explain differential susceptibility to     functional impairment in the presence of pathology or other neurological insult. CR is     estimated using variables for cognitive activity: years of education, professional status,     socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model     that depend on brain size and other quantitative aspects of the brain that explain     differential susceptibility to functional impairment in the presence of pathology.      Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to     brain injury. On the other hand, CR influences the severity and the expression of cognitive     diseases.      The investigators realize a prospective study in order to assess the impact of CR and BR on     cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.   "
35650|NCT02819154|"     Patients are admitted to intensive care for serious diseases (sepsis, ARDS ...) burdened with     a high mortality rate. Invasive methods of resuscitation and the diseases treated can lead to     serious sequelae. Follow-up studies of patients at hospital discharge report most often the     quality of life using validated quantitative scales. A recent consensus of the American     Society of resuscitation an update on the physical, cognitive and psychological sequelae of     ICU hospitalization for the family and the patient, grouped under the term post-intensive     care syndrome. Social changes, emotional and professional are little studied and are not     part of the information provided by the quality of life questionnaires. The investigators     hypothesize that intensive care stay entails a profound effect on the lives of patients. This     study will add additional data on a little known aspect of post resuscitation.   "
35743|NCT02817932|"     The purpose of this study is:      To assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and     Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg     after single and repeated oral administrations.   "
47878|NCT02658929|"     Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in     adults with relapsed/refractory multiple myeloma (MM).   "
35651|NCT02819141|"     The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for     the self-management of sedative therapy (SMST) in a sample of critically ill patients     receiving mechanical ventilator support. The investigators hypothesis is that self-management     of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU),     tailored to their individual needs will be more efficacious than nurse-administered sedative     therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and     occurrence of delirium.   "
35652|NCT02819128|"     Hypothesis:      Homeless people have infections not diagnosed with a potential impact on their health status.      Main Purpose: Improve the etiological diagnosis of endemic and/or emerging pathologies among     homeless people.   "
35653|NCT02819115|"     Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal     vaccine.   "
35654|NCT02819102|"     This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and     intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects.     Pharmacokinetics of the probe substrate drugs will be measured prior to and following     administration of multiple doses of BCX7353.   "
35655|NCT02819089|"     The purpose of this study is to determine the recovery profiles after general anesthesia in     patient undergoing anterior cervical spine surgery. This study will compare the Riker     sedation agitation scores between two groups, with or without dexmedetomidine as an     anesthetic adjuvant.   "
35668|NCT02818907|"     This study aims to collect clinical, biological and quality of life data from patients with a     borderline or resectable pancreatic cancer. It will collect information from the date of     diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end     of the treatment. The database will be updated at each patient's visit. Biological samples     will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality     of life will be assessed by the EORTC standard. The objectives of this database are to     identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality     standard research protocol.   "
35670|NCT02818881|"     This study examined the muscle activity, movement patterns, and oxygen consumption during a     series of yoga poses with slow and rapid transitions.   "
35656|NCT02819076|"     Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn,     especially after a birth injury, but it is sometimes difficult ti define.      There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data     available are those of the perinatal survey 2010, with the number of operative vaginal     deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the     seat (4.7%). These delivery modes can be purveyors of pain.      At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions     by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013,     and 15 in the delivery room. But this consumption is a poor reflection of the pain because     treatment could be given pain-authenticated (measured with the EDIN scale), and because a     bottle is discarded one month after opening.      The scales measuring pain used in the new-born at term based on the assessment of change in     behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale     Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related     to health care.      The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in     children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute     or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant     proportion of newborns. This scale appears suitable for evaluation of the newborn to term     maternity   "
35657|NCT02819050|"     Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of     non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not     well established. In this prospective, two-center randomized control trial we hypothesize     that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP     off in infants born between 23 0/7-30 6/7 weeks of gestational age.   "
35658|NCT02819037|"     The objective of this research is to determine the incidence of microbial overgrowth of the     small intestine before and after a gastric bypass. For this purpose, the study is based on     the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3,     6, 12, 18 and 24 months.   "
35659|NCT02819024|"     This pilot research trial studies the effects of dexamethasone in patients with non-small     cell lung cancer that has not responded after previous treatment. Drugs such as dexamethasone     can affect how tumors grow and respond to treatments. Imaging tests, such as     fluoro-L-thymidine (FLT) positron emission tomography , use a small amount of radioactive     substance to show changes in tumor cells. Studying the effects of dexamethasone on lung     tumors using FLT positron emission tomography may help doctors plan better treatments.   "
35660|NCT02819011|"     The investigators propose a randomized control trial to evaluate long term effects and     effectiveness of Ankle foot orthoses (AFO) in reducing risk of falling in older adults.      Primary Endpoints • Characterize the impact of AFO on balance, gait, risk of falling, frailty     status, and adverse events      Secondary Endpoints • Characterize the Impact of AFO on spontaneous daily physical activities     • Characterize the feasibility of the AFO device on patient adherence, acceptability,     user-friendliness, and perception of benefit for daily usage   "
35661|NCT02818998|"     To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different     intravitreal (IVT) treatment regimens to subjects with DME pretreated with 2 mg aflibercept     every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according     to the EU label for the first year of treatment)   "
35662|NCT02818985|"     Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.   "
35663|NCT02818972|"     Investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects     with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the     descending thoracic aorta.   "
35664|NCT02818959|"     The objective of this study is to evaluate feasibility, safety and effectiveness of the first     generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus     System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at     high risk for surgical aortic valve replacement.   "
35665|NCT02818946|"     The purpose of the proposed prospective study is to determine the diagnostic value of MRI for     the evaluation of patients with pathologic nipple discharge. Breast surgeons will identify     clinic patients with pathologic nipple discharge (unilateral and bloody or unilateral and     clear) and refer them for breast MRI. When the clinical team notifies the study team that an     MRI has been ordered for that purpose, the study team will consent patients to document the     results and follow-up. The study team will not be obtaining MRI's on patients for research     purposes only. The following data will be collected and analyzed: patient age,     characteristics of the discharge (laterality, spontaneous versus expressed, duration of time,     color, presence of blood), imaging workup and findings, BI-RADS final assessment categories,     pathology results from core biopsy and/or surgical excision, and clinical and radiologic     follow-up data during the two years after presentation. Participation in this study poses     minimal risk to patients. Risks to the subjects include loss of confidentiality and     unnecessary breast biopsy. The risks associated with MRI are minimal; however, since a     gadolinium-based contrast agent will be administered for the MRI, patients with compromised     renal function and patients who are pregnant will be excluded from the study.   "
35666|NCT02818933|"     The purpose of this pilot study is to assess the quality of self-report data obtained using     the Automated Self Administered 24-Hour Recall (ASA24-Kids-2014) relative to an interviewer     administered 24-hour recall in a sample of adolescents ages 12-17 years, to determine their     method preference, and to assess issues related to each method.   "
35667|NCT02818920|"     This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab     administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery     (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a     type of immunotherapy that may enhance the ability of the immune system to fight off cancer.     The study will investigate the effects of pembrolizumab on the immune system and how certain     immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab.     Previous studies suggest that pembrolizumab could alter the immune cells in a way that the     the immune cells identify cancer cells. Pembrolizumab has been approved for the treatment of     advanced lung cancer, but is investigational in this setting.   "
35671|NCT02818868|"     The aim of this study is to investigate the clinical events of the patients with acute     cerebral large vessel occlusion or stenosis and atrial fibrillation, treated by apixaban     within 14 days after onset. This is the observational study that patients will be made the     registration at the timing of both retrospective period and prospective period.   "
35672|NCT02818855|"     Gingival recession (GR) is frequently associated with deterioration in dental esthetics and     dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when     the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use     of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps     (CAF) appears to be more predictable, and may be considered the gold standard procedure.     However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the     need for a donor surgical area, which may increase the risk of surgical complications like     bleeding, as well as increases post-operative discomfort and the period of the surgical     procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for     the SCTG. The use of CM was associated with a significant reduction in post-operative     morbidity, less post-operative pain and discomfort in the patient, and more esthetic     satisfaction.   "
35673|NCT02818842|"     Medication during pregnancy can lead to the occurrence of birth defects or neonatal     pathologies. Thalidomide or diethylstilbestrol (Distilbene °) are prominent examples. Many     drugs remain insufficiently evaluated in this area and doctors are too often deprived of     relevant information when prescribing drugs in pregnant women.      To fill this gap, the investigators have put in place since 2004, a database, EFEMERIS,     recording products given to women during pregnancy in Haute-Garonne (data from Primary Health     Insurance Fund), fate of these pregnancies and the state health of newborns (Mother and child     protection data, prenatal Diagnostic Centre and Medicalisation Program of Information Systems     data).      Women included in this database (> 90 000 to date) has allowed us to study the risks of     taking certain medications still not assessed in pregnant women (for example phloroglucinol,     the H1N1 flu vaccine , oseltamivir ...). Each year about 10 000 pregnant women join the     cohort. The collection and management of data concerning require careful organization and     mobilize multiple stakeholders.      The pursuit of these inclusions is needed to study medication less often prescribed but raise     questions. For example, if the investigators consider that the relative risk of cardiac     abnormalities following in utero exposure to paroxetine is multiplied by 1.5, it will take     1,000 women exposed to paroxetine for 5 additional cases observed. In December 2013, 0.3% of     women EFEMERIS were exposed to paroxetine in the first quarter (274 women).      The objective of this project is to continue the EFEMERIS project (funded for 10 years public     tenders until December 2015) by continuing to include pregnant women (about 10 000 per year)     in order to explore the potential effects of exposure to different drugs on the newborn     (prematurity, birth defects, neonatal diseases).      The processing of data will EFEMERIS to detect drugs at risk to the fetus and provide a     warning role in terms of malformation effects, to monitor over time prescribing practices,     participate in pharmacoepidemiology international multicenter studies including similar     databases in general population.   "
35674|NCT02818829|"     BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national     institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This     base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA     and RNA from tumors cells.      The mission of this prospective project is to make available to the scientific community a     clinical biological base from patients with pancreatic adenocarcinoma   "
35683|NCT02818712|"     Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality.     Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about     the properties of recently developed HRQL questionnaires and about the longitudinal changes     in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on patients     with IPF, but reports differ in incidence and prevalence. The impact of comorbidities on HRQL     and disease progression has only been studied sparsely. Also, the association between     biomarkers and disease progression need to be examined further.   "
35684|NCT02818699|"     The purpose of this clinical study is to determine the effect and safety of long-term intake     of enzymatically modified isoquercitrin (EMIQ), a natural plant product on body fat loss in     obese and overweight individuals.   "
35685|NCT02818686|"     This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and     pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28     days. This exploratory study will also serve as a signal seeking endeavor to demonstrate     biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic,     and histologic assessments.   "
35675|NCT02818816|"     Patients with prostate cancer undergoing robot assisted radical laparoscopic prostatectomy     (RALP) in steep Trendelenburg position (sTBURG) are noted to have elevated intraocular     pressures (IOP) intraoperatively. One study showed an increase in IOP of 13 millimeters of     mercury (mmHg) from baseline IOP levels intraoperatively. Other studies have shown the IOP to     more than double intraoperatively during RALP in sTBURG. IOP is found to be directly related     to angle of inclination and increases time dependently with sTBURG. The IOP may remain     significantly elevated until the first postoperative day after RALP.      There are no previously published data concerning the safe threshold for IOP elevation and     the effects of this increased IOP on vision and on generalized eye health are still not     entirely known. One study showed postoperative visual field defects in 28% (7/25) of patients     who underwent RALP in sTBURG. It has been theorized that sTBURG and subsequent increased IOP     are risk factors for postoperative vision loss (PVL). It is believed that the increased IOP     decreases optic nerve perfusion pressure causing ischemic optic neuropathy. Some previously     recommended ways to reduce the intraoperative IOP spike during RALP include shorter operating     times, decreased angle of inclination, modified Trendelenburg position, use of Propofol for     maintenance anaesthesia and intraoperative topical hypotensive agents to reduce IOP. Given     the challenges with some of the above options, this study aims to evaluate the effect of     pre-operative treatment with topical Brimonidine Tartrate 0.2% on the IOP of patients     undergoing RALP with sTBURG. The goal is to prevent the anticipated IOP spike thereby     reducing risk of postoperative vision loss.   "
35676|NCT02818803|"     The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment     of oral candidiasis, more specifically denture stomatitis. Half of participants will receive     a standardized-propolis (EPP-AF®) gel formulation while the other half will receive     miconazole gel, both for oral use.   "
35677|NCT02818790|"     The goal of the MI field test is to assess users' overall satisfaction, usability and     acceptability of the PRECIOUS system, and to explore if MI in combination with gamification     principles is a feasible solution to foster adherence to PRECIOUS system. Moreover, it is     pursued to trigger behavior change and build up motivation to maintain sustained change     towards healthy lifestyles. The field test at University Hospital Vall d'Hebron will be     carried out with morbidly obese pre-diabetic patients. This pilot test will serve to explore     users' acceptance of PRECIOUS system in an early stage of its development. Considering that     this is a pilot test, feedback and outcomes obtained will serve to refine and adjust PRECIOUS     system concept and architecture.   "
35689|NCT02818634|"     The purpose of this study was to investigate the effect of 'muscle sparing technique' while     harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative     pain. Although authors report 'muscle sparing technique' cause less pain its not investigated     in an evidence-based-medicine perspective. Therefore the investigators are planning a     controlled, prospective clinical trial to compare the conventional method and 'muscle sparing     technique'.      Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle     Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial   "
36299|NCT02810626|"     The goal of this project will be to demonstrate that Synaptive Medical's Diffusion Tensor     Imaging(DTI) product functionality used in pre-operative planning and intraoperative surgical     navigation, improves clinical outcomes corresponding to a reduction in neurological and     neuropsychological deficits in pediatric brain tumor surgery.   "
35678|NCT02818777|"     There are two stages in the study. The major purpose of the Stage 1 is to study the safety     and tolerability of the proposed dosage regimen of the study drug. The form of cannabidiol     (CBD) used in this study is GWP42003, supplied by GW Pharmaceuticals. The dosage regime is     based on their experience. This is an open label study in 10 subjects, during which the dose     is gradually increased to the manufacturers recommended target dose, with tolerability being     evaluated at each dose level. Based on the response of subjects in the Stage 1, a target dose     is determined for the next stage. Standardized tools will be administered to study both     tolerability and efficacy. Efficacy assessments are simply explorative, and are done to look     for an effect that warrants specific or different evaluation in the next stage.      The major purpose of Stage 2 is to assess the safety and tolerability of the GWP42003-P at     the determined dose, and secondarily to study efficacy, particularly regarding tremor. Stage     2 is a crossover, double-blind, randomized controlled trial (RCT) with 50 subjects.   "
35679|NCT02818764|"     The overall objective of this study is to test for perturbations in intraoperative     electroencephalogram (EEG) , cerebral blood flow (CBF), cerebral metabolic rate of oxygen     consumption (CMRO2), oxygen extraction fraction (OEF), and serum and cerebral spinal fluid     biomarkers associated with delirium in high risk population having elective hip arthroplasty     at Penn Presbyterian Medical Center (PPMC).   "
35680|NCT02818751|"     Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents with Anxiety. To     determine the effects of escitalopram on functional activation patterns during a Continuous     Performance Task with Emotional and Neutral Distracters, the CPT-END. To examine baseline     functional activity and functional connectivity profiles in the ventrolateral prefrontal     cortex as markers of subsequent treatment response to escitalopram in adolescents with     generalized anxiety disorder (GAD). To use proton magnetic resonance spectroscopy (1H MRS) to     examine glutamatergic and γ-aminobutyric acid (GABA)-related abnormalities in the anterior     cingulate in adolescents with GAD as compared to healthy adolescents.   "
35681|NCT02818738|"     Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most     patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim     of this study is to assess the efficiency of a 6-months levamisole course, given early after     first remission, on maintaining a relapse-free course at 12 months.   "
35682|NCT02818725|"     OBJECTIVES OF THE TRIAL      Primary objective      Evaluation of efficacy in terms of progression-free survival at 9 months of the combination     of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without     panitumumab as first-line treatment of advanced urothelial carcinoma in patients without     Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.      Secondary objectives        -  To assess toxicity        -  To assess response rate        -  To assess overall survival        -  To assess time to progression        -  To study the correlation between response rate, time to progression, overall survival          and biological parameters   "
35686|NCT02818673|"     Refractory ascites is an indication for liver transplantation, and includes ascites that is     resistant to, or intractable by diuretic therapy (International Ascites Club). This     definition is partly subjective; it can be established only a posteriori, following diuretic     therapy administration to all patients, including those in whom untoward effects are     prominent; and requires prolonged follow-up. An early diagnosis of refractory ascites would     avoid giving diuretic therapy to patients in whom it will fail and identify rapidly     candidates to liver transplantation. Such diagnosis could be done with a pharmacokinetic (PK)     study of radiolabeled albumin between the peritoneal cavity and serum.   "
35687|NCT02818660|"     There are two main stimulation tests used to decide if a patient has cortisol deficiency. It     is the synacthen test, were we stimulate the patient with intramuscular or intravenous     synacthen ( ACTH) to see how much cortisol the adrenals are capable of producing, and it is     the Insulin hypoglycemia test were we give the patient insulin to provoke a hypoglycemia,     and look at the adrenal response to that stimulus. The cut off values for a normal response     is based on old immunological assays no longer in use. Assays with a lot of interference and     cross reactivity leading to measurement of higher values for cortisol than what we measure on     the highly specific LCMS/MS ( Liquid chromatography mass spectrometry methode) that we are     using for cortisol today. So, there is a need for new cut off values for a normal response to     such tests. The purpose of this study is to produce such new cutoff values by performing the     test in 120 healthy controls. We also want to perform the test in patient groups normally     going trough this tests according to the same protocol as the control persons, to evaluate     the new cutoffs in different patient groups.   "
35688|NCT02818647|"     Patients 13-years-or older who undergo tonsillectomy operation (without another additional     surgery) will be enrolled in the study. Randomly, one side is going to be operated with     conventional cold-knife technique and hemostasis will be maintained with bipolar diathermy     (25-30w). Contralateral tonsil is going to be operated with needle-tip monopolar     electrocautery (10-12w) at Blend 1 mode and hemostasis will also be maintained with     needle-tip monopolar cautery. Postoperative tonsillar fossa healing and pain is going to be     evaluated for both sides separately with Visual Analogue Scale. All operations are going to     be performed by a single surgeon and all evaluations are going to be carried out by another     surgeon in a totally blinded fashion to avoid possible bias.   "
35690|NCT02818621|"     Dexmedetomidine, a selective alpha2-adrenergic agonist is known to reduce propofol and opioid     requirements due to its sedative and analgesic properties. However, until now, there has been     studies based on indirect measures such as hemodynamics. Entropy shows to quantify the level     of consciousness by EEG and Surgical pleth index(SPI) allows to predict the effect of pain     stimuli and analgesic therapy by the index of the nociception-anti-nociception balance. The     investigators analyzed quantitatively the requirements of propofol and remifentanil under     continuous infusion of dexmedetomidine when using entropy and SPI.   "
35691|NCT02818608|"     The aim of this study is to verify the effects of the Transcranial Direct Current Stimulation     (tDCS), Functional Electrical Stimulation (FES), and the combination of both therapies (tDCS     + FES) for rehabilitation of chronic stroke patients.   "
35692|NCT02818595|"     Many cognitive functions in humans are based on asymmetrical brain networks. For example, in     most adults, the language is essentially processed by the left hemisphere, while other     auditory functions, such as voice recognition, tend to be processed by the right hemisphere.     Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the     presence of anatomical and functional asymmetries by the first months of life. What are the     causes of these asymmetries? How do they develop? Are they necessary for functioning or     effective learning?      This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif     El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of     development at which hemispheric dominance for voice recognition is first observed and to     identify the brain structure involved in preterm neonates whose sound environment is usually     very different from that of the foetus. The impact of this environment on the infant's brain     development and early learning will be evaluated.   "
35693|NCT02818582|"     Background:      Some people have Ebola virus in their body for months after they recover from Ebola virus     disease. Some may have health problems from the virus while others are fine. These people may     be able to pass the virus to others. There are currently no drugs for people who have     survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734,     might help get rid of Ebola virus in semen.      Objective:      To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans.      Eligibility:      Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola     virus in their semen      Design:      Participants will be screened with:      Questions      Physical exam      Eye exam      Blood tests      2 semen samples if they have not had it tested recently      Participants must live near the study site in Liberia for 6 months.      Participants will be put into 1 of 2 study groups. They will have an infusion of either     GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The     infusion lasts 1 hour.      Participants will be observed for 1 hour after. They will provide a semen sample on infusion     day 4.      After the infusions, participants will have 5 visits in the first month, then 1 per month for     5 more months. These include giving a blood and semen sample.      Blood tests are performed before and after each infusion and the last visit (5 month visit)     will also include an eye exam.      When the study is over, if the study drug works and is safe, participants who got the placebo     can get the study drug.   "
35694|NCT02818569|"     The broad objective of this investigation is to assess the safety and efficacy of oral     therapy with dexmedetomidine for the induction and maintenance of restful sleep.   "
35695|NCT02818556|"     This will be a single-center, randomized, evaluator-blinded, split-face clinical study     design. Fifty patients will receive one treatment session consisting of Restylane® Silk     (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose     conversion ratio) injections to the superficial, vertical perioral lines. Injections will be     performed at the baseline visit. To ensure subject and investigator blinding, syringes will     be prepared and labeled 1 and 2 immediately before subject attendance for injection by     the sub-investigator. The same injection sites and techniques will be used on both sides of     the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150,     180.   "
35697|NCT02818530|"     Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position     and studies showed that IOP reaches peak levels after steep Trendelenberg position on an     average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are     aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle     tone.      Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the     anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They     concluded that bedside ultrasound could be useful in evaluating patient with suspected     increased IOP, who are unable to open their eyes.   "
35698|NCT02818517|"     The survival rate of cancer patients has greatly increased over the past decades' mainly due     to early detection and the use of new medications with higher doses and combined protocols.     This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction     ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the long     term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for many     types of cancer. As a result of the increasing number of long-term cancer survivors the     magnitude of this problem is growing. Early identification of cardio toxicity can be     identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers     (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the     addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the     patient's treatment may prevent the development of cardiac dysfunction. However, currently     there are no specific or clear guidelines for the follow-up and management of cardio-toxicity     in cancer patients.      The aim of the study: To try to identify who are the patients at increased risk for     developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and     echocardiogram examination, in purpose of early diagnosis, management and prevention of     cardiac events. For achieving this the investigators will build a registry which will include     all the oncologic patients going an evaluation in the cardio-oncology clinic in the Tel Aviv     Medical Center .   "
35699|NCT02818504|"     Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse,     high blood lipids or sugar and arterial hypertension. Systems for self-learning and     self-monitoring may help people improve and maintain a healthy lifestyle through tailored     suggestions about diet, weight control, physical activity, fatigue,stress.      SEMEOTICONS exploits the human face as an indicator of individual's health status and     translates signs obtained from the face using contactless sensors into measures and     descriptors to be automatically evaluated by a an interactive smart mirror. This Wize     Mirror extracts descriptors from videos, images and gas concentration signals and integrates     them in a virtual model used to compute and trace the evolution of an individual's wellness     index. A health diary enables each individual to evaluate and personally relate his/her     lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution     of the wellness index and of each descriptor, to provide useful suggestions on correct     lifestyle self-monitoring.      The purpose of this study is assess the accuracy of the information derived from the Wize     Mirror in expressing the health status of the individual.      The reproducibility and repeatability study will evaluate whether measurements are stable     over short time spans and whether they are influenced by meals light and temperature     conditions.      To verify whether the Wize Mirror is able to detect variations in physical and emotional     health status with appropriate lifestyle changes, the validation study will cross-check     measurements from the Wize Mirror against reference clinical tests at enrolment and after 3     months of personalized suggestions for healthy behavior.      Reference tests include        -  Physician visit        -  Measurement of blood oxygen content and skin end products of sugar metabolism,body          composition, energy expenditure, vascular function        -  Laboratory profile and exhaled gas composition        -  Questionnaires on quality of life and lifestyle (food, sleep, physical activity,          smoking, alcohol, stress).      Wize Mirror measures include        -  3D reconstruction of face images for roundness, color, stress and fatigue        -  Heart and respiratory rate        -  Detection of skin sugar metabolism end-products and of eye lipid deposits        -  Small vessel vasodilating ability with local heating The results will allow to assess          whether the Wize Mirror is easy to use and helpful for self-monitoring of          cardio-metabolic risk.   "
35700|NCT02818491|"     Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene     brachial plexus block is considered by many as the gold standard for treating postoperative     pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus     in the neck. Duration of analgesia is between eight to twelve hours depending on the type of     administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in     anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different     trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics     for a perineural injection may prolong the duration of analgesia up to 24 hours. In a     meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated     through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose,     without neurological complications. The objective of this multicenter randomised controlled     double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that     purpose, investigators will include a total of 150 patients divided in 5 groups: local     anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.   "
35701|NCT02818478|"     To investigate if electronic reporting of patient reported outcome measures from home is     comparable to the traditional touch-screen solution to hospital among patients with     rheumatoid arthritis and axial spondyloarthritis   "
35702|NCT02818465|"     Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high     cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest,     advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze the     role of RAGE in the calcification process of hemodialyzed patients, in a correlative and     prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while     accumulation of AGEs will be measured in the serum and in the skin (non invasive).     Additionally factors influencing RAGE activation such as genetic polymorphism and level of     soluble forms of RAGE will be measured and analyzed.   "
35703|NCT02818452|"     The objective of this study is to determine the effect on glycemic responses of adding     various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the     dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when     added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at least     20% less than that elicited by a β-glucan-free cereal.   "
35802|NCT02817165|"     In North America, one of the most common reasons for hospitalization in previously healthy     children is for the treatment of infections with antibiotics. This study will determine if,     in previously healthy children hospitalized and prescribed intravenous (IV) antibiotics, the     co-administration of a probiotic milk product containing good bacteria, is safe and effective     for reducing AAD, as compared to a placebo (identical appearing milk product). This will be a     two-center, randomized, masked, placebo-controlled clinical trial. The results of this study     will help inform clinicians and families on the use of probiotics in the prevention of AAD, a     common side effect of antibiotic use among hospitalized children.   "
35704|NCT02818439|"     ARPEGE project fits within the general framework of maintaining functional autonomy in the     frail elderly. The early identification of elderly people at risk of frailty is essential to     be able to make corrective actions to maintain a quality of life desired by the person.     ARPEGE offers tracking and monitoring based on a corpus mobile evaluation of frailty, that     could be used in various environments (home, prevention center, office of the general     practitioner, geriatric consultation), and manipulated intuitively by professionals not     specialists.      This four-year project spearheaded by the University of technology of Troyes in partnership     with the University of Reims Champagne-Ardenne also brings a set of partners and experts in     the region and outside, so that the proposed solution has the qualities necessary for its     deployment in terms of value diagnostic, use, acceptability and perfectly controlled ethics.      The Region has made longevity aging theme one of its priorities. This image of driver of     innovation in this area can only be enhanced by a program like ARPEGE. Beyond the scientific     and technological results expected, one can imagine the potential socio-economic benefits if     this tracking solution is deployed on a large scale.   "
35705|NCT02818426|"     UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce strong     TH1 CD4 T cell responses in cancer patients.      Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by     using Continuous Reassessment Method (CRML) dose escalation design model.      The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to     estimate its Maximum Tolerated Dose (MTD).      The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax     according to the dose level.   "
35706|NCT02818413|"     This research is being done to investigate fecal microbiome and metabolome as well as serum     analytes and single nucleotide polymorphisms in Olympic athletes in comparison with other     elite athletes.   "
35717|NCT02818270|"     Aerosol delivery through a ventilator is influenced by numerous factors from     ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery     through a ventilator system was studied on bench model with albuterol, yet the results were     often overestimated. The objective of this study was to evaluate inhaled bronchodilator and     mucolytic agents delivered through a ventilator system.   "
35718|NCT02818257|"     The aim is to investigate the impact that water absorption properties in adhesives has on     adhesion.   "
37047|NCT02800759|"     Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC).     Nutraceuticals containing CMO are used to improve knee pain despite the lack of     placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial     is to explore the minimal effective dose of CMO for relieving knee joint pain.   "
35707|NCT02818400|"     In hindsight, the first face graft raises the fundamental problem of composite tissue     allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific     technical and philosophical problems.      By proposing a prospective study concerning five new patients over the next three years, in     the light of this first experience, the authors would like to confirm the surgical     feasibility of this type of procedure, possibly extending it to other parts of the face     (lateral third) and, like English and American teams, considering the possibility of total     facial surface reconstruction.      In parallel, and while complying with the usual immunosuppression procedures, the deliberate     choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and     quantity of which will need to be determined) will be reaffirmed, in order to improve     mucocutaneous tissue tolerance, while confirming the safety of this type of approach.      Five new cases will also provide observations for the many new fields of research developing     around composite tissue transplants (neurophysiology, skin histopathology, psychiatry,     haematology, immunology, etc.).   "
35708|NCT02818387|"     Propofol is a well-known induction agent which can provide sound and quick hypnosis with     anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while     using this agent. Propofol in combination with remifentanil or midazolam can result in     synergistic or additive effect in elderly patients. There are not many studies which provide     minimum dose of propofol to induce hypnosis in combination with these agents and advantage of     the combination.      The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are     enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR).     Sample size have been decided due to the previous studies which have mentioned 40     participants as a adequate sample size for this biased coin design - up and down study.      After receiving informed consent, patients will be participated in this study. No     premedication will be given to the patients before induction. The patients in group P will     receive general anesthesia only with propofol and group PR and PMR will receive 0.125     mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in     group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the     remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose     will be changed by the result of prior study participant.      'Success' of this study will be defined as loss of both verbal response and eyelash reflex in     3 min after propofol administration. When 'success', the next patient will receive the same     dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol. When     'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at induction     period.   "
35709|NCT02818374|"     The purpose of this study is to evaluate the efficiency and the safe use of a new medical     device to improve the oral accessibility of disabled people during the oral-dental     examination.   "
35710|NCT02818361|"     Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for     treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its     reproductive system toxicity. The investigators are inspired by Chinese external therapy, an     immemorial therapy for thousands of years, and take its advantage to make TwHF topically in     order to get an effective and safe treatment for active RA patients.   "
35711|NCT02818348|"     This study aims to provide information about the safety and pharmacokinetic drug-drug     interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in     HIV-infected patients, as well as evaluate the efficacy of concomitant administration of     darunavir/cobicistat and etravirine.   "
35803|NCT02817152|"     The aim of this study was to investigate the local effect of adjunct low-level laser therapy     (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic     patients.   "
35712|NCT02818335|"     The purpose of this study is to measure how much LY3023414 (a test formulation and a     reference formulation) gets into the blood stream and how long it takes the body to get rid     of it.      The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking     LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations     will be evaluated. Information about any side effects that may occur will be collected.      This study includes 3 periods. Participants will be admitted to the clinical research unit     (CRU) one day before dosing in each period. Total study duration is about 21 days, including     follow-up. Screening may occur up to 30 days before the first dose of study drug.      This study is for research purposes only and is not intended to treat any medical conditions.   "
35713|NCT02818322|"     The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to     compare telemedical + standard and standard alone outpatient monitoring in the care of     patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of     the overall study is the time of ulcer healing. The number of amputation, hospital admissions     and surgical procedure will be also reported. Investigators hope to include 150 patients in     this study.   "
35714|NCT02818309|"     Lesogaberan may be used in Chinese GERD patients with partial response to PPI.   "
35715|NCT02818296|"     This investigation examines the efficacy of a brief, one-session computerized interpretation     bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty.     Intolerance of uncertainty is a risk factor for the development and maintenance of various     forms of psychopathology.   "
35716|NCT02818283|"     Combination antiretroviral therapy (ART, HIV medications) dramatically increases the expected     lifespan of HIV (Human Immunodeficiency Virus)infected patients; yet, the risks for     cardiovascular disease (CVD), such as heart attacks and stroke, are increased in this     population. This increased risk may be linked to persistent inflammation and activation of     the immune system. Although the relationship between cardiovascular disease and HIV-infected     individuals who are taking HIV medications is not well understood, the team of researchers     involved in this study observed that a diet rich in soy, at levels recommended by the FDA     (Federal Drug Administration), improved cholesterol levels and inflammation in individuals     not infected with HIV. From this study, the researchers hope to gain understanding on how     dietary soy will impact HIV-infected individuals who are taking HIV medications. Two pretzels     with and without soy developed at OSU (Ohio State University) in the Department of Food     Science and Technology and used in previous clinical trials will be used to investigate how     the pretzel snacks will affect your cardiovascular disease risk, immunity, and how your body     breaks down naturally occurring chemicals from soy.   "
37048|NCT02800746|"     The objective of the present study is to determine the impact of preoperative IV-iron (ferric     carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood     transfusion amount in patients undergoing elective prognathic surgery.   "
35719|NCT02818244|"     In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to     expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that     track heart rate are predicted to be the most popular. At the elite level, commercial heart     rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew     Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of     ordinary consumers purchase fitness trackers that include heart rate monitors in order to     help them to maintain their health and wellness. As popularity of these fitness devices     grows, assessment of the accuracy of heart rate measurements becomes increasingly important.   "
35720|NCT02818231|"     Nasal adenocarcinomas are closely related to wood dust exposure. The precise mechanisms of     carcinogenesis leading to the transformation of the respiratory mucosa into a colonic-like     mucosa remain unknown: chronic exposure to wood dust may cause chronic inflammation that may     lead to pre-degenerative lesions, hypothesis yet unconfirmed. The tumor development requires     the activation of a particular gene: CDX2. The working hypothesis is that chronic wood dust     exposure is responsible for changes in genes of inflammation, which can in turn lead to     changes in the expression of CDX2 and its cofactors, thus making possible the genesis of     adenocarcinoma. This work is a pilot study aiming to better understand the mechanisms of     carcinogenesis, and to study the feasibility of a larger prospective screening for     woodworkers adenocarcinomas. Cells will be obtained from the at risk area (olfactory cleft)     by a noninvasive method (brushing) in healthy volunteers (unexposed to wood dust) and in     exposed volunteers to compare their genomes and study the genomic changes related to wood     dust exposure.   "
35721|NCT02818218|"     Consecutive patients undergoing liver transplant surgery will be included in the study.     Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during     the postanhepatic phase and following closure of the deep fascial layer of the anterior     abdominal wall simultaneous measurement of SVC diameter, SBC collapsibility index and CVP     will be recorded.   "
35722|NCT02818205|"     The purpose of this study was to explore the feasibility of detecting physiological patterns     of arousal to sensory inputs in children with and without Autism Spectrum Disorder (ASD).     Accordingly, two questions directed this methodological research investigation: (1) Is there     a relationship between rest (tonic) and response (phasic) patterns of arousal among typically     developing children and children with ASD?, and (2) Is there a difference in EDA response to     sensation between typically developing children and children with ASD?   "
35744|NCT02817919|"     This cohort event monitoring will document real-life safety experiences following the intake     of Injectable AS. Specifically, the study will record common adverse events that are     associated with the use of Inj. AS and associating factors such as age and gender that make     some of these events more likely. The sample size of 3000 patients will enable the     documentation of causally-related events that occur at frequencies of 1 in 1000 or more.     Since quinine, the previous gold standard for treating severe malaria may still be used by     facilities in addition to artesunate and artemether, the study will concurrently monitor the     safety of these products though focus of the study is the capture of adverse events following     exposure to Inj. AS. The concurrent monitoring of both quinine and artemether will also     enable treatment practices in the study areas to be documented.   "
35745|NCT02817906|"     This is a randomized, double-blind, placebo-controlled study comparing the efficacy and     safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation     in patients with dementia, including Alzheimer's disease.   "
35723|NCT02818192|"     The overall aim of the project is to elucidate the primary bio-psycho-social (BPS) risk     factors for albuminuria in youth with type 2 diabetes (T2D) and the mechanisms by which they     cause renal injury. The Study Aims include:        1. Characterize the primary BPS risk factors associated with prevalent and progressive          albuminuria in youth with T2D.        2. Determine individual, family and community level factors that influence biological and          psychological risk factors and behaviors (adherence) that could be modified to protect          against prevalent and progressive albuminuria.        3. Determine if systemic and renal inflammation is the common pathway through which BPS          risk factors lead to albuminuria in youth with T2D.      Study Hypotheses include:        1. Biological factors (poor glycemic control and systolic ambulatory hypertension), and          psychological and social adversity (stress, mental distress and poverty) are significant          predictors of prevalent and progressive albuminuria in youth with T2D.        2. Community and family support will be negatively associated with stress, and a lower risk          of both prevalent and progressive albuminuria.        3. Systemic and renal inflammation is the common pathway through which BPS risk factors          lead to albuminuria in youth with T2D.   "
35724|NCT02818179|"     This research aims to investigate the correlation between tumor temperature difference and     biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.      In addition, normal tissue response to radiation therapy in treated organ will be evaluated.   "
35725|NCT02818166|"     The purpose of this study is to prospectively evaluate major and minor neurologic events in     patients undergoing right mini-thoracotomy mitral valve surgery and to compare different     aortic clamping techniques; specifically, the endoaortic balloon with retrograde perfusion     (Endoreturn) and the transthoracic clamp with retrograde perfusion. Major neurologic events     will be evaluate through standard neurologic evaluation; minor neurologic events will be     evaluate through magnetic resonance (MR) assessment.      The first aim of the study is to determine the number and impact of microembolic events     during right mini-thoracotomy mitral valve surgery on clinical neurological status and on MR     evaluation. The investigators also aim to determine if different techniques of aortic     clamping may impact on early outcome.      Study hypothesis: despite recent concerns arising about endoaortic balloon with retrograde     perfusion, the investigators expect to show equivalence in term of safety and effectiveness     of this technique compared with the transthoracic clamp in a selected population.   "
35726|NCT02818153|"     Allergic rhinitis is a common condition that affects adults as well as children and     adolescents, often with impaired quality of life. Patients often report a poor level of     satisfaction with the effectiveness of their treatment and are always looking for more drug     combinations to improve their symptom. Several tools exist for assessing control of allergic     rhinitis, but none has been validated in adolescents or in children. A study conducted in     2008, resulted in the validation of a self-administered control test of allergic rhinitsis     (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents     aged 12 to 17 years old and lacked power.      In this new study,the investigators propose, following exactly the same procedure as the     pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in     adolescents 12 to 17 years inclusive.   "
35727|NCT02818140|"     Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain,     despite a multimodal analgesic regime.      We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will     significantly reduce postoperative opioid consumption and pain following PNL operation     compared with placebo (saline) TQL block.      The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block     concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime     alone (and placebo TQL block) in a randomized and placebo controlled design.   "
35728|NCT02818127|"     The aim of this study is to evaluate and describe the total coronary circulation time (TCCT)     by using TIMI frame count method in patients performed coronary angiography. TCCT is     described as an angiographic index which is the sum of the frame count of coronary artery and     venous system. This study also evaluates the relationship between the diseases in arterial     system such as coronary artery ectasia, coronary slow flow, coronary artery disease and     coronary venous pathologies.   "
35729|NCT02818114|"     The investigators plan to develop and test an intervention using peer specialists (Veterans     who have managed PTSD and completed PE) to provide support services for Veterans using     prolonged exposure therapy.   "
35730|NCT02818101|"     The purpose of this study is to confirm the utility for hypnosis in the coronary angiographic     examination. The technique would be an alternative to prevent the consumption of anesthesic     drugs.   "
35731|NCT02818088|"     This unique study will allow us to observe the neural correlates associated with working     memory in an obsessive compulsive disorder (OCD) paradigm. We believe that developing working     memory in participants suffering with OCD will reduce the severity of their symptomology.     This will allow a greater understanding into the functioning of these participants which in     turn presents with treatment possibilities.   "
35732|NCT02818075|"     This pilot study will evaluate the feasibility and acceptability of a mobile phone based peer     support intervention among adolescent mothers. Half of the participants will receive usual     care plus the peer support intervention and the other half of the participants will receive     usual care only.   "
35733|NCT02818062|"     The host-immune reaction to infection is essential for the comprehension of the disease and     the development of new therapies.      The aim of the study is to describe intraocular cytokines network in aqueous humor using     multiplex immunoassay, during severe intraocular infection.   "
35775|NCT02817516|"     The purpose of this study is to evaluate the safety and tolerability of multiple oral doses     of TAK-828 in healthy participants.   "
35776|NCT02817503|"     The purpose of the current feasibility study is to test whether the blood pressure level of     the study patients can be effectively and safely managed according to the intensive     antihypertensive treatment protocol. Furthermore, the study will also examine the effect of     intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes,     including CIMT, carotid plaques, PWV ABI, and kidney function, etc.   "
35804|NCT02817139|"     This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare     the effects of transcranial direct current stimulation in Chronic Migraine.   "
35734|NCT02818049|"     The acute respiratory distress syndrome (ARDS) is a clinical syndrome characterized by an     inflammatory pulmonary edema, severe hypoxia and endothelial and epithelial diffuse     aggression. A European study estimated that this disease represents 7% of admissions to     intensive care. Despite progress on the modalities of mechanical ventilation, mortality is     always between 25 and 55%. The definition of this syndrome was recently amended by     individualizing three sub groups based on the importance of hypoxemia (mild, moderate and     severe). Achieving a bronchoalveolar lavage (BAL) by bronchoscopy remains a gold standard in     the initial research of pulmonary infectious cause or secondarily face the suspicion of     ventilator-associated pneumonia. Cardio pulmonary consequences of this act are not well known     in patients with ARDS. The first studies on the consequences of a bronchoscopy on oxygenation     of a patient breathing spontaneously have 40 years. More recent work showed a simple     bronchoscopy could in the mechanically ventilated patient cause an average decrease of 26%     from the base of PaO2, 10% of the mean arterial pressure (MAP) and a significant increase in     cardiac output. The existence of ARDS was an independent risk factor associated with     hypoxemia. A study by published in Crit Care Med in 1990 can serve as a reference in     ventilated patients benefiting from BAL by bronchoscopy: in a subgroup of 26 patients, 23% of     patients required an increase in the fraction of inspired oxygen (FiO2) post procedure. A     study compared changes in PaO2/FiO2 after BAL with and without endoscopy among patients     without (n = 23) or with pneumonia (n = 11): the decrease in PaO2/FiO2 was significant only     in the pneumonia group. In a study of 30 patients ventilated but not hypoxic , PaO2 was     still reduced by 20% 2 hours after the completion of a BAL in 40% of patients. A     retrospective series of 99 ventilated patients but not hypoxic, shows that the BAL was well     tolerated in accordance with a pre oxygenation procedure 15 min and by gradually decreasing     the FiO 2 after the end of the procedure. BAL also appears well tolerated in a study of 12     patients ventilated under sedation and muscle relaxation, in shock and in need of positive     expiratory pressure (PEEP) of at least 10 cm H2O but the authors show a decrease in PaO2 that     extends well beyond the end of the intervention. Their conclusion is going to offer less     invasive diagnostic techniques for patients with PaO2 less than 60 mm. No study has targeted     the respiratory and hemodynamic consequences of this technique depending on the intensity of     ARDS (mild, moderate or severe).   "
35736|NCT02818023|"     The study plans to treat patients with pembrolizumab and thus blocking the PD-1/PD-L1 axis     would render tumor-infiltrating lymphocytes (TILs) in the tumor parenchyma more functional as     a consequence of BRAF inhibition, such that T cell activation by BRAFi would not be dampened     by the PD-1/PD-L1 interaction. This combination would reverse dysfunction among T cells in     the tumor parenchyma, maximizing T cell mediated immune anti-tumor efficacy. Progression free     survival (PFS) with pembrolizumab in KEYNOTE-001 was 57% at 6 months, and 46.4% in the more     recently reported phase III trial. PFS with vemurafenib treatment in BRIM-3 was ~50% at 6     months. Combined treatment with pembrolizumab and vemurafenib for BRAF mutant melanoma is     hypothesized to be safe and to improve the PFS compared to these recent historical controls.     Because this combination has not yet been tested, and because the primary objective is to     assess safety, the investigators are staging accrual in the first phase of the trial. The     study aims to accrue up to 50 patients to the mTPI design of this study with the expectation     that there will be at least 30 patients treated at RP2D. In case there are less than 30     patients on the RP2D, additional patients will be accrued. Patients will continue to receive     treatment with pembrolizumab and vemurafenib until disease progression or toxicity. Patients     with treatment response and no dose limiting toxicity may receive treatment with     pembrolizumab for up to 24 months.   "
35737|NCT02818010|"     PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups:     patients exposed to physical activity and unexposed. The main objective of the study is to     compare the evolution of glomerular filtration rate at inclusion and 12 months later between     patients practicing physical activity and patients not practicing. If necessary, the renal     disease-related complications, which are not influenced by physical activity: (type of kidney     disease, age and tobacco), would be taken into account. TIRCEL patients with chronic kidney     disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum creatinine data,     12 months prior to inclusion, is collected retrospectively. Patients are followed in the     trial during 12 months. To evaluate physical activity, patients respond to Global Physical     Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During this 12 months     period, the same biological data are collected prospectively.   "
35738|NCT02817997|"     The purpose of this study is to collect clinical, laboratory, and patient survey data from     patients with Castleman disease to improve understanding, diagnosis, and treatment of the     disease.   "
35739|NCT02817984|"     The purpose of this study is to assess the safety and tolerability of acellular adipose     tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy     volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon     injection into human soft tissue.   "
35750|NCT02817841|"     The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding     pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol     (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.   "
35740|NCT02817971|"     A cluster randomised pragmatic trial will be conducted within an emerging clinical     information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to     an enhanced feedback intervention delivered over a nine-month period and compared to standard     feedback. The trial to be implemented during a phase of implementing change in guideline     recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake     of the revised pneumonia treatment recommendations.   "
35741|NCT02817958|"     Squamous cell carcinoma of the penis is a rare tumor in Europe, whose prognosis and survival     are influenced by metastatic lymph node involvement. Its frequency in France is estimated at     less than 1% of human cancers. This spread follows a sequential process via the superficial     and deep inguinal lymph nodes and then to the pelvic lymph nodes before metastatic     dissemination.      The management of inguinal areas is the cornerstone of penile cancer. It is curative in about     80% of patients with 1 or 2 inguinal metastases. 5-years overall survival was on average 85%     for pN0 patients and 40% for pN + patients. For pN + patients, 5-years overall survival was     70 to 80% for pN1 (only 1 lymph node invasion), and 30 to 40% for pN2 and 0 to 10% for pN3.      The risk of local recurrence is 5-10% for pN0 and 20-30% for pN + after local treatment by     lymphadenectomy alone without chemotherapy. The average time to recurrence was 10 months.     Disease-free survival at 5 years is 75-85% for pN0 and 30-45% for pN +. Its indication     depends on clinical examination (presence or absence of lymph nodes palpated) and the risk of     nodal disease (≥ pT1bG2).      Currently, a fine needle biopsy is the best clinical diagnosis method because it is a simple,     low risk and possible in consultation. When the result is positive, it allows an early     dissection. Single or double fine needle biopsy will be used in cN + patients. For patients     at risk of lymp nodes involvement (cN0 and ≥ pT1B or G2), the sentinel node diagnosis may be     followed by modified or bilateral lymphadenectomy.      Although lymphadenectomy alone has a curator action, it sometimes remains insufficient in     patients with metastatic lymph node involvement. Therefore it seems important to develop a     multimodal approach in the management of these patients in order to increase the response     rate to treatment and survival.      From a Phase II trial conducted on 30 patients, the combination TIP (paclitaxel, ifosfamide     and cisplatin) appears to have an efficacy / toxicity acceptable.      The TIP protocol has therefore been chosen for this trial as adjuvant or neo-adjuvant     treatment in patients with high risk of lymph nodes involvement (cN0 and ≥ pT1B or G2), and     with inguinal mobile palpated lymph nodes (cN +) respectively, after lymph nodes involvement     proven (pN +).   "
35805|NCT02817126|"     The purpose of this study is to evaluate the safety and oncological feasibility of     robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.   "
35746|NCT02817893|"     The waveform plethysmographic signal can be used to establish an index for predicting fluid     responsiveness (∆POP: respiratory variation of the plethysmographic waveform of pulse     oximetry). This index was validated in some studies and because of its non-invasiveness it     seems very interesting in anesthesia.      However, in a previous study the investigators evaluated the correlation between the results     provided by this index (∆POP) and those of the reference index (∆PP: pulse pressure     variation), and the obtained results were significantly lower than what had been previously     described. In this study, the index was calculated from a recording of a filtered signal.     This unavoidable application of a filter on anesthesia monitors could contribute to the     discrepancy between the ∆POP and the ∆PP.      The realization of a new study, comparing ∆PP and ∆POP obtained from an unfiltered     plethysmographic signal, should answer the ∆POP ability to be used in place of ∆PP.   "
35747|NCT02817880|"     The purpose of this study is to compare the analgesic effectiveness of two motor cortex     neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the     algoneurodystrophy.   "
35748|NCT02817867|"     Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity     in the Brazilian population, and is considered a major cause of disability in adults. Brain     damage caused by stroke generates a maladaptive pattern of neural activity and modulation     between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This     condition affects patient's functional recovery.      The aim of this study is to verify the effectiveness of repetitive transcranial magnetic     stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct     Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these     two types of brain stimulations on the upper limb recovery after stroke.   "
35749|NCT02817854|"     Diverticular disease is a common disease in developed countries, affecting 2.5 million     individuals in the United States (US). Prevalence of diverticula increases with age and goes     up to 50 to 66% in patients older than age 80 years. Approximately 10 to 25% of patients with     diverticulosis will develop diverticulitis. Acute diverticulitis (AD) accounts for 312,000     admissions and 1.5 million days of inpatient care in the US, where its annual treatment costs     exceed 2.6 billion dollars. With the ageing of global population these numbers are expected     to rise.      Procalcitonin (PCT) is a biomarker widely used to monitor bacterial infections and guide     antibiotic therapy in Intensive Care Units and has been shown to be useful in different     surgical fields such as acute appendicitis. Recently, has been demonstrated that PCT and CPR     have good predictive value of anastomotic leak (AL) after colorectal surgery.      A multicentric study has been designed to test if PCT, CRP and WBC values might be able to     predict the outcomes of patients admitted in emergency setting for acute diverticulitis. In     particular if they might distinguish between patients needing only conservative (nothing per     os, iv fluids and antibiotics) or interventional therapy such as radiological drain or even     surgery, in the aim to optimize and individualize each patients therapy and speed patients     discharge.   "
35752|NCT02817815|"     Arterial thromboembolism constitutes a major risk of atrial fibrillation (AF) requiring     antithrombotic therapy. Platelets and microparticles (MPs) are important for hemostasis and     thrombosis, their role during AF is not well known. The principal objective of this study is     to compare morphologic, functional and proteomics characteristics of blood platelet between     AF patients and healthy volunteers.   "
35753|NCT02817802|"     The registry will investigate the clinical performance and long-term safety of Magmaris in a     real world setting   "
35754|NCT02817789|"     Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic     stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure     and during few weeks after implantation in the aim to minimize cerebral embolization. But for     now, the best antiplatelet regimen has to be determined. In this context, investigators want     to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves     lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients     in each group in terms of early safety (30 days) after the procedure.   "
35755|NCT02817776|"     This is a prospective, multicenter, non-randomized clinical evaluation utilizing the     THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.   "
35756|NCT02817763|"     The aim of the present study is to evaluate the clinical, aesthetic and patient-centered     parameters of connective tissue graft associated or not with partial resin composite (RC) for     the treatment of gingival recession with NCCL, performed before the surgical procedure.   "
35757|NCT02817750|"     The purpose of this study is to evaluate the pharmacokinetics of the new formulation of     zolpidem hemitartarate orodispersible tablet 3.5 mg in male and female healthy volunteers.   "
35758|NCT02817737|"     Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of     the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty.      Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy     participants using computed tomography (CT). The CTA, angle between clinical transepicondylar     axis and posterior condylar line were measured. The PTA is the angle formed between the     mechanical axis of the tibia and tibia plateau line. The correlation between the CTA and the     PTA was analyzed statistically with the linear regression.   "
35759|NCT02817724|"     The purpose of this study is to determine if it is better an integral strategy, with a     m-health system, when used in addition to a supervised treatment, versus the use of the     m-health system alone, to improve the immediate and long-term Quality of Life of breast     cancer survivors.   "
35791|NCT02817308|"     Ductal adenocarcinoma of the pancreas is the fifth leading cause of cancer related deaths in     the European Union. Tumor markers CA19-9 and carcinoembryonic antigen are important     components in decision making and follow-up of patients diagnosed with this disease.      These tumor markers were found to be elevated not only in the serum but also in other body     fluids in patients with malignant lesions of the parotid gland and the urinary tract. The     authors have described in a previews small preliminary study a positive and a strong linear     correlation between the levels of CA19-9 in urine and saliva with those presented in the     serum of patients with ductal adenocarcinoma of the pancreas. The current study seeks to     enlarge the study population to confirm the previous results and standardize the measured     levels of CA19-9 in these body fluids.   "
35760|NCT02817711|"     The prospective Cohort includes all patients with bone or joint infection (BJI), with or     without implant. The aim of this Cohort is to improve the knowledges about the treatment     failure and the occurrence of serious adverse events. Various data of patients included are     collected and will be analysed.      Patients with a bone or joint infection are treated at the department of infectious diseases,     at Infectious disease department of Hospices Civils de Lyon. They have regularly a     consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after     surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It     allows to the physician to follow the evolution of the patient under treatment and after     discontinuation of the treatment.      Several data are collected during the follow-up concerning: demographics data, treatment     including the use of off-label antibiotics for the treatment of BJI, adverse events,     microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If     there is an implant, the date of implantation and the number of the prosthesis infected are     collected.      This cohort allows to improve knowledge concerning the treatment failure and the occurrence     of adverse events.   "
35761|NCT02817698|"     The investigators' project has two overarching goals. 1) The investigators will use newly     developed positron emission tomography (PET) technology to investigate the dopaminergic     neurochemistry of drugs of abuse including marijuana, traditional cigarettes, and cocaine,     and 2) The investigators will extend PET technology to an additional neurotransmitter system     - namely, the opioid-ergic system, using the same drugs of abuse.   "
35762|NCT02817685|"     This study is a randomized control prospective study. The aim of this study is to establish     an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and     diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance     time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic     patients with different risk of HCC.   "
35763|NCT02817672|"     The goal of this project is to conduct a pilot study to test the utility of a Natural     Language Processing (NLP) clinical messaging tool to improve the reach and the quality     (fidelity and competency) of coaches providing behavioral activation (BA) strategies through     a mobile mental health app called Personalized Real-time Intervention for Motivational     Enhancement (PRIME). This study will improve the reach of clinicians by using a NLP-powered     messaging tool, which will ensure fidelity to the BA model and clinicians will have access to     real-time clinical information about their patients to guide more targeted treatment     (competence). If successful, PRIME could operate as a cost effective tool for clinicians to     extend their reach and an accessible treatment for the population of those struggling with     depression.   "
35764|NCT02817659|"     To further understand the tolerability of glucagon.   "
35765|NCT02817646|"     The purpose of this study is to determine whether protein intake during the first days of     intensive care admission, in relation to body composition at intensive care admission as     assessed on computed tomography scans made during routine care, is are related to clinical     outcome in critically ill patients.   "
35766|NCT02817633|"     This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T     cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and in     combination with an anti-PD-1 antibody, in patients with advanced solid tumors who have     limited available treatment options. The study will be conducted in 2 parts: dose escalation     and cohort expansion.   "
35767|NCT02817620|"     The purpose of this pilot study is to assess the beneficial effect of a spirulina water     extract (product named Spirulysat®) compared to a placebo in the blood level ratio of     oxidized LDL / total LDL cholesterol in subjects with metabolic syndrome after 12 weeks of     consumption   "
35769|NCT02817594|"     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)     has been shown to be safe and effective in randomized controlled clinical trials with strict     inclusion and exclusion criteria under well controlled conditions.      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±     RBV, used according to local label, under real world conditions in the Netherlands in a     clinical practice patient population.   "
35770|NCT02817581|"     To validate the NEWS and rapid lactate testing for early identification of high risk [triage     Category 3 (urgent)] patients in the Emergency Department.      To compare qSOFA and SIRS criteria in patients in the Emergency Department.   "
35771|NCT02817568|"     The aim of this study is to estimate genetic impact of MCP-1 -2518 and its receptor CCR2 -190     polymorphisms on AgP patients among Turkish individuals and whether MCP-1 genotype effects     mRNA levels of Peripheral Blood Mononuclear Cell Leukocyte (PBML)   "
35772|NCT02817555|"     The purpose of this study is to determine if there is a cost difference between darbepoetin     alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.   "
35773|NCT02817542|"     Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on     admission have high rates of mortality (1). The management of hyperglycemic patients during     STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary     percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic patients     (2).      Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI     undergoing quantitative coronary angiography were studied. Patients were categorized in two     groups, either treated by thrombus aspiration v/s patients treated without thrombus     aspiration. After discharge from the hospital, all patients will be managed and followed     quarterly for 12 months month after event, as outpatients, to perform clinical evaluation,     routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in both     cohorts will include cardiac mortality, all-cause mortality and hospitalization for coronary     disease and heart failure.      Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA     before PCI, as compared to hyperglycemic patients treated only by PCI.   "
35774|NCT02817529|"     Positive expiratory pressure (PEP) therapy is a device aiding airway clearance and secretion     mobilization, also prevent the small airway from collapsing. The purpose of this research is     to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. Patients'     compliance, satisfaction, 3 months and 6 months lung function test and life quality will be     compared.   "
35777|NCT02817490|"     The Ehlers-Danlos Syndrome (SED) comprises a group of clinically and genetically     heterogeneous, inherited connective tissue diseases. The hypermobility type is the most     frequent. It is characterized by a generalized joint hypermobility and a hyperextension skin.      Chronic pain syndrome is often present. Its psychological impact can be significant (anxiety,     depression, impact on the quality of life of the patients). The disease also requires changes     and a permanent adaptability (coping). It can lead to feelings of isolation and     misunderstanding.      The French association of the Ehlers-Danlos Syndromes and the rehabilitation center of the     'Croix-Rouge Française des Massues' propose a patient education program for the patients with     a hypermobility type SED (the PrEduSED program). This education program is open to patients     and their caregivers located in France.      The research hypothesis is that the PrEduSED program improves their coping and reduces     patient anxiety at 6 months (these are the two clinical criteria on which the PrEduSED could     have the most impact, given the results of the first sessions).   "
35778|NCT02817477|"     Introduction: Ketamine has been well studied for its efficacy as an analgesic agent. However,     intranasal (IN) administration of ketamine has only recently been studied in the emergency     setting.      Objective: To elucidate the efficacy and adverse effects of a sub-dissociative dose of IN     Ketamine compared to IV and IM morphine.      Methods: A single-center, randomized, prospective, parallel clinical trial of efficacy and     safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency     department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe     acute traumatic pain (≥80mm on 100mm Visual Analog Scale [VAS]) were randomized to receive     either 1.0mg/kg IN ketamine, 0.1mg/kg IV MO or 0.15mg/kg IM MO. Pain relief and adverse     effects were recorded for 1 hour post-administration.      Primary Outcomes: The primary outcome was efficacy of IN ketamine compared to IV and IM MO,     measured by time-to-onset (defined as a ≥15mm pain decrease on VAS), as well as time to and     degree of maximal pain reduction.   "
35779|NCT02817464|"     The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of     TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive     effect when injected every 6 months.   "
35780|NCT02817451|"     Study is to assess and confirm the adequate immunogenicity and safety profile of the Sanofi     Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in     HIV-exposed uninfected infants (HIV-exposed uninfected) and in HIV-exposed infected infants     (HIV-exposed infected).      Primary Objectives:        -  To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary          series in HIV-exposed infected and in HIV-exposed uninfected infants.        -  To describe the persistence of all antibodies before receipt of the booster vaccination          in HIV-exposed infected and in HIV-exposed uninfected infants.        -  To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in          HIV-exposed infected and in HIV-exposed uninfected infants.      Secondary Objectives        -  To describe the safety profile after each and all doses of the study vaccine          administered as a 3-dose infant primary series in HIV-exposed infected and in          HIV-exposed uninfected infants.        -  To describe the safety profile of the study vaccine administered as a booster in          HIV-exposed infected and in HIV-exposed uninfected infants.   "
35781|NCT02817438|"     This study examines how online self-guided programs can improve mood and anxiety symptoms.     These programs use exercises from Cognitive-Behavioral Therapy, which is an evidence-based     treatment for depression and anxiety. The purpose of this study is to learn who will do best     with the online format. Our aim is to learn for whom online self-guided interventions are     most efficacious. This knowledge is important because it will help inform clinicians and     patients about who might benefit from this type of intervention versus who would need the     assistance of a therapist. More specifically, we hope to figure out who would benefit from     solely an online intervention and who would benefit from an online intervention in addition     to other treatment.   "
35782|NCT02817425|"     This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or     SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer,     observe and record the efficacy and tolerance,to evaluate which regimen is better.   "
35783|NCT02817412|"     This study will examine the effectiveness of food response training interventions in reducing     binge eating among adults engaged in binge eating.   "
35784|NCT02817399|"     The purpose of this study is to examine the short term effect of functional electrical     stimulation treatment versus neuro-muscular electrical stimulation on gait quality for     patient after anterior cruciate ligament reconstruction.   "
35785|NCT02817386|"     The purpose of this study is to investigate the possible relationship of microRNA and     postoperative delirium.   "
35786|NCT02817373|"     This study is designed to predict implantation of a fresh, high quality embryo in an in vitro     fertilization (IVF) cycle by using ultrasound based uterine factors.   "
35788|NCT02817347|"     In patients with otitis media presenting with otoscopy-confirmed otorrhea who had     tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability,     and the proportion of patients with cessation of otorrhea after ear-drop administration of     YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.   "
35789|NCT02817334|"     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer     localization.      In this study, our hypothesis are as following:        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure          better outcome.        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.   "
35790|NCT02817321|"     This prospective, randomized study,control study aims to compare the analgesic effect,opioids     consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al.     between single-injection TPVB(thoracic paravertebral block) , single-injection TPVB     +continuous TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients     undergoing hepatectomy with right J-shape subcostal incision.   "
35792|NCT02817295|"     an examination of the different aspects of bariatric surgery in elderly in comparison with     non-elderly patients.   "
35793|NCT02817282|"     Hand hygiene (HH) appears to be a simple, non-complex procedure to prevent     healthcare-associated infections (HAIs), implementation in daily routine is difficult. The     residential setting and specific population pose challenges to optimal HH compliance. This     study aims to develop and to evaluate an evidence based multi-component implementation     strategy aimed at the promotion of HH in Dutch nursing homes(NHs). A strategy to improve HH     compliance in Dutch NHs will be developed. This strategy addresses the specific barriers and     facilitators of NHs' infrastructure, healthcare workers (HCWs) and socio-cultural setting.     The strategy will be tested in a stepped wedge cluster randomized design which is based on a     random sequential roll-out of the implementation strategy to all participating NHs (n=20) for     comparison. Data are collected during six consecutive four month periods with an initial     baseline period for all NHs.      During each period 1200 opportunities for HH are observed, using the gold standard of direct     and unobtrusive observations, according to the Five Moments for HH of the World Health     Organization. HAIs incidence densities, collected in the sentinel surveillance network for     infectious diseases in nursing homes (SNIV), will be evaluated in parallel.      A multi component implementation strategy, combining activities aimed at individual HCWs,     teams and the organization will be used. The individual level includes education, skills,     action planning, reminders and feedback. The team level includes activities that focus on     social influence, strengthening of leadership by gaining active commitment and initiative of     ward management. The organizational level addresses the structural context and institutional     management support.      To assess the cost implications of the CHANGE strategy, an economic evaluation will be     conducted from a healthcare perspective. The cost-effectiveness of improved HH, defined here     as the costs for the CHANGE strategy minus less costs for treating infections, divided by the     difference between HAIs before and after the intervention period, will be calculated. A     process evaluation will be performed during and after the intervention to investigate the     feasibility of the implementation strategy and to illuminate the mechanisms and processes     responsible for the results and their variation within the NHs.   "
35794|NCT02817269|"     The first aim of the study will be to identify the most common ReP pattern and compare its     coincidence with that described by Travell and Simons. Second, the study aim will be to     verify whether there are any significant differences by sex and types of technique used in     regard to the ReP pattern of TrP 2 of the infraspinatus muscle, an area described as more     sensitive.Finally, the third aim of the study will be to determine whether deep dry needling     will evoke the LTR and ReP more easily than manual palpation.   "
35795|NCT02817256|"     Bariatric surgery is emerging as an essential treatment option for the management of obesity     and its associated comorbidities. Many patients present for surgery have pre-existing low     blood vitamin levels, thus all bariatric surgical procedures compromise nutrition to varying     extents, and may present potential threat of micronutrient deficiencies. Therefore, long term     nutritional monitoring and follow-ups are vital components of all bariatric surgical     patients. However, there are no current standard practices in United Arab Emirates (UAE) for     the biochemical monitoring and replacement of essential micronutrients in patients undergoing     bariatric surgery particularly the most performed Sleeve Gastrectomy. Medical practice     guidelines recommend nutritional care however, the dose and route of administration     supplementation after surgery based on randomized controlled trials is not yet established.     Till tow no scientific study has been performed on monitoring vitamins and minerals levels     following bariatric surgery among UAE population. Therefore, present study is aimed to     determine the dose and route of administration of vitamins and minerals in improving the     micronutrient deficiencies post-operatively. Two standard different dosage forms (oral     /parenteral) of vitamins and minerals will be given to the patients who had undergone sleeve     gastrectomy at Tawam Hospital. The dosages of the supplementations are within the     international recommendations and patients will be followed up closely for a period of one     year. The effect of nutritional deficiencies on micronutrient level and quality of life (QOL)     will be assessed. This will help the medical practitioners to prove the optimal possible     nutrition for patients.   "
35796|NCT02817243|"     The purpose of the study is to investigate the potential interaction between multiple oral     doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.   "
35797|NCT02817230|"     In this study, the investigators will determine whether patients with elevated levels of LDL     are characterized by specific epigenetic changes in circulating cells of the innate immune     system, compared to control subjects with healthy levels of LDL and whether regular statin     treatment influences these changes.   "
35798|NCT02817217|"     The purpose of the study is to investigate the potential PK interaction between SP2086 and     Valsartan after multiple oral doses treatment in healthy male volunteers.   "
35799|NCT02817204|"     The purpose of this study is to determine the effect of aerobic exercise training on     microcirculation rarefaction in Chinese young male primary hypertensive patients stage 1.     Hypertension is one of the most common world-wide chronic diseases, and it is showing a     growing younger trend, which with mild blood pressure elevated would not be diagnose in time     until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood     pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However,     cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with     even primary hypertension stage 1. Exercise prescription is gathering great importance in     preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure     values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch     signaling plays an important role in vascular formation and maintenance. However, there is no     prospective, randomized, controlled, clinic trial to investigate the effect of exercise on     microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis     that aerobic exercise might not only have a blood pressure lowing effect but also improve     microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that,     subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and     then randomized in aerobic exercise intervention group and control group (only health     education), the intervention will be carried out by Cycle Ergometer, the protocol consists of     3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10     minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in     total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy     and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well     as 24h blood pressure monitoring, echocardiography, forearm blood flow and reactive hyperemia     by venous occlusion plethysmography (FMD), PWV, central arterial pressure, RHI with Endopat,     also the quantification of endothelial progenistor cells(EPCs) separated from peripheral     blood.   "
35800|NCT02817191|"     The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on     ocular surface and tear inflammatory mediators in patients after Phaco+IOL.   "
35801|NCT02817178|"     The investigators recently identified promiscuous HLA-DR-derived epitopes from the human     telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study     tumor-specific CD4+ T cell responses.      The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long     term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil     -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and     unpublished data).      Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post     chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in     metastatic colorectal cancer patients and their correlation with progression-free survival.   "
36901|NCT02802683|"     The purpose of this study is to compare the frequency of hypotension between hyperbaric     anesthetics and isobaric anesthetics during cesarean section and determine whether continuous     infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.   "
35806|NCT02817113|"     NC-6004 is a polymeric micelle containing cisplatin as an active moiety. The nanoparticle     provides sustained release of the active moiety and utilizes the enhanced permeability and     retention (EPR) effect to target release of platinum to tumors. This Phase I study aims to     establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and     cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell     carcinoma of the head and neck for further clinical study development.   "
35807|NCT02817100|"     This study is a first in human study that will investigate the safety, tolerability and     pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled,     randomized, single center design. In addition the influence of itraconazole and food on the     pharmacokinetics of BAY1817080 will be investigated.   "
35808|NCT02817087|"     Transcranial magnetic stimulation for post-stroke upper-body motor deficits.   "
35809|NCT02817074|"     Phase III randomized controlled trial designed to test the effects of a 3-year intervention     of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive     decline and brain neurodegeneration among 600 individuals 65+ years without cognitive     impairment who are overweight and have suboptimal diets.   "
35810|NCT02817061|"     Aim: Investigate whether transcranial photobiomodulation (tPBM) using near-infrared light     exposure to the head, can improve frontal lobe executive function, working memory and overall     mood in normal volunteer participants.      Hypothesis: The investigators predict that tPBM will increase cognitive functioning, as     measured by Cambridge Cognition cognitive testing in study subjects.   "
35811|NCT02817048|"     Chest tube placement after thoracoscopy surgery had been generally accepted as routine     procedure for removal of the residual intrapleural fluid and air, however, it would cause     post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay.     According to the recent studies, omission of chest tube placement after minor thoracoscopic     procedures (such as pulmonary wedge resection) had been safe and feasible, and it also     reduced the post-operative pain and shortened the hospital stay. We will conduct a     prospective randomized trial in National Taiwan University Hospital.   "
35812|NCT02817035|"     To make these definitions of neural inspiratory time (Ti) and expiratory delay clearly.The     present study was undertaken to examined the physiological signals of patients and healthy     subjects during spontaneous breathing and noninvasive mechanical ventilation.   "
35813|NCT02817022|"     Enrolled neonates will be provided routine supportive care as per existing neonatal intensive     care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of     study commencement. This group will serve as control group (group A). During subsequent 6     months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion     criteria will be provided routine supportive care and the components of developmentally     supportive care (DSC).   "
35814|NCT02817009|"     Childhood obesity is a contributing factor to health complications such as diabetes, heart     disease, high blood pressure, cancer and asthma. It is of particular concern among Hispanic     populations in the United States as that group has the fastest growing childhood obesity     rate. Nearly two in five Hispanic children ages 2 to 19 are overweight or obese. This program     aims to test whether it is beneficial to routinize a multi-disciplinary pediatric weight     management program within the highest volume clinic (NYU-LFHC Women, Adolescents and     Children), and to add a home-visit component to reinforce teaching on food selection and     preparation. The intervention will include 27-hour intervention session which will be     distributed into 12-session series over a 3 month period. The program will target Hispanic     children between the ages of 9 and 11 with a Body Mass Index (BMI) between the 95th and 99th     percentiles. To assess the effectiveness of this program, the investigators propose to     conduct a general prospective study using randomized pre-test and post-test control group     design with minimal risk for participants.   "
35815|NCT02816996|"     The goal of this study is to find the effect of holding a patient's hand on anxiety and pain     during dermatologic procedures.   "
35816|NCT02816983|"     Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA)     are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions.     Patients with <=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as     definitive treatment. Blood draws will be taken to monitor the development of anti-prostate     cancer immunity   "
35817|NCT02816970|"     An open label randomized, single dose, two-way crossover bioequivalence study to determine     the bioequivalence of Vildagliptin from Gliptus 50 mg tablet (EVA pharma, Egypt) and Galvus     50 mg tablet (NOVARTIS PHARMA, GERMANY) in Healthy Human Volunteers Under Fasting Condition   "
35818|NCT02816957|"     Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa     in children with beta thalassemia major.   "
35819|NCT02816944|"     The purpose of this study is to evaluate the safety and efficacy of endoscopic     ultrasonography (EUS) guided laser ablation liver, pancreas, and retroperitoneal tumors, the     investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and     laboratory tests including the tumor markers to evaluate the general condition of patients.     Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.   "
35832|NCT02816775|"     The intubation response to airway manipulation during direct laryngoscopy can cause     hypertension, dysrhythmias and increased intracranial and intraocular pressures. This intense     physiological response is proven to be associated with adverse outcomes especially in elderly     patients. Increased QT dispersion is associated with increased risk of ventricular     arrhythmias, which may increase the risk of sudden death caused by life-threatening     arrhythmias. McGrath Videolaryngoscope would generate a lesser haemodynamic response than the     conventional method of direct laryngoscopy. The objective of this study was to compare the     hemodynamic response and QT during following tracheal intubation, using videolaryngoscope or     direct laryngoscope to intubation. The postoperative airway morbidities is the investigators     secondary outcome.   "
36045|NCT02813980|"     The investigators believe epilepsy alters the way the body controls blood pressure, heart     rate and breathing, and these changes increase the risk of sudden unexpected death in     patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these     changes to the heart and blood vessels. This research study measures those differences which     may help identify new markers to help predict those patients at greatest risk in the future.   "
35820|NCT02816931|"     Multi-drug resistant tuberculosis (MDR-TB) is steadily increasing world-wide, urging for the     need of improved treatment strategies. In order to protect the few available drugs that are     left, ensuring adequate plasma concentrations of the drugs are important. Individualized     therapy using plasma drug concentrations and minimal inhibitory concentration (MIC)     determination may be of importance (1). The plasma drug concentrations and the MICs of the     second-line drugs will be compared, aiming at increasing the knowledge about     pharmacokinetic/pharmacodynamic (PK/PD) indices in the treatment of MDR-TB. In the future,     the aim is an individualised therapy, where sub-therapeutic drug concentrations can be     adjusted by the use of therapeutic drug monitoring (TDM). TDM in the treatment of MDR-TB may     improve clinical outcome for the patients, but plasma concentrations must be assessed     together with clinical and microbiological factors (2).      In this observational study the hypothesis is that the ratio between drug concentrations and     MICs of the anti-tuberculous drugs, are correlated to the time to sputum culture conversion,     the bacterial load measured as time to positive liquid culture (TTP) and clinical outcome.     Consenting adult patients with pulmonary MDR-TB patients in China will be recruited.     MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug     concentration will be determined at 2, 4 and 8 weeks after treatment initiation using liquid     chromatography tandem mass spectrometry (LC-MS/MS), simultaneously assessing Dried Blood Spot     (DBS) as a bio-sampling method. Sputum cultures will be obtained regularly throughout the     treatment to measure the time to culture positivity (TTP). Clinical follow up according to     WHO criteria will be performed at the end of treatment completion.   "
35821|NCT02816918|"     intends to evaluate the feasibility and security issues of univent bronchial blockers outside     the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery     patients.   "
35822|NCT02816905|"     This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the     IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to     compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children     under 13 years of age who underwent bilateral strabismus surgery.   "
35823|NCT02816892|"     This study aims to investigate Serum Tenascin C levels in patients with acute symptoms     relating to a known or newly diagnosed aortic aneurysm in emergency department and reveals     the possible role of Tenascin C in the development of the disease.   "
35824|NCT02816879|"     This clinical trial compares three anal cytology collection procedures (collected at a single     visit) in men who have sex with men (MSM). It also compares two different tests for human     papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur     before anal cancer. This study may help doctors develop better screening for high-grade anal     dysplasia in MSM in order to identify those who need to return for additional screening and     treatment.   "
35825|NCT02816866|"     The main purpose of this study is to research the comparative effectiveness of two potential     models of health care to deliver preventive services and chronic care management to the     growing population of adult and pediatric survivors of childhood cancer. The central     hypothesis is that survivorship care delivered by a subject's primary care doctor after the     subject is empowered with individualized follow-up recommendations prepared by a cancer     survivor specialist is similar to care provided in a specialty survival clinic.   "
35826|NCT02816853|"     The purpose of this study is to assess the effects of domperidone on the QTc interval     duration in Chinese healthy adult participants after multiple domperidone doses of 10     milligram (mg) 3 times a day (tid) and 20 mg tid.   "
35827|NCT02816840|"     The trial is to explore new and effective techniques in the treatment of prostate cancer and     evaluate the role of PET-CT / MRI played in radiotherapy. Intensity modulated radiation     therapy(IMRT) is adopted with all patients and the efficacy assessment for the prostate     cancer will be examined with PET / CT or CT in three months after radiotherapy.   "
35828|NCT02816827|"     The current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental     alertness as compared to placebo.   "
35829|NCT02816814|"     Healthy lifestyle, based on healthy diet and exercise, is a key factor to prevent the most     common menopausal disorders and chronic diseases to which women are more exposed during this     life stage. Therefore, menopausal women may represent a target for evaluating the     effectiveness of nutritional intervention studies based on protective diets against the     common metabolic diseases, such as metabolic syndrome, obesity and hepatic steatosis.      Lipidomics aims to study the lipid molecules in a dynamic way and allows to define not only     structure and functions of a set of lipid species present in an organism, but also the     changes that occur during cell metabolism under physiological and pathological conditions in     order to understand their role as part of the complex functional balance of a living     organism.      Quantitative and qualitative determination of fatty acids profiles in cell membranes allows     to follow their molecular changes occurring for intrinsic and extrinsic metabolic causes,     such as inflammation, stress, nutrition.      Scientific evidence has shown that, for nutritional studies, the most representative cell is     the erythrocyte, which is a biomarker of an individual's general state of health. In fact,     the evaluation of the fatty acid composition contained in the membrane of red blood cell,     which has an half-life of four months, allows to follow the nutritional status of a subject     and to acquire information about his eating habits, with special reference to fat     consumption.      The higher intake of omega-3 fatty acids is associated with a decreased inflammatory state     which is often altered in patients with metabolic diseases, hepatic steatosis and obesity.      Overweight or obese women in menopause for at least 12 months, aged between 45 and 68 years,     will be submitted at baseline to blood samples for lipidomic profile, blood tests, medical     examination with blood pressure and anthropometric measurements (weight, height, waist and     hip circumferences), indirect calorimetry and bioimpedentiometry. Participants will be     randomly assigned to diet with extra virgin olive oil (LoVE DIET) or to diet riched in     omega-3 fatty acids (LωVE DIET) for four months. During the treatment period, women enrolled     will undergo medical examination and dietary control to assess the adherence to the dietary     pattern, collecting anthropometric measurements, indirect calorimetry and bioimpedentiometry     after 4 and 16 weeks as well as blood samples after 16 weeks.      The results will be analyzed using appropriate statistical tests. All patients will be made     to sign an informed consent.   "
35830|NCT02816801|"     In this study, effectiveness of an internet based intervention (Butler 2.0) for elderly is     tested. Participants (n= 60) will be randomly assigned to two different groups (intervention     vs. waitlist). Outcomes in terms of loneliness and quality of life will be assessed at pre-,     post (6 weeks) and follow-up (3 months).   "
35831|NCT02816788|"     In partnership with SARI Therapeutic Riding (SARI TR), Brescia University College, at the     University of Western Ontario, will study the use of Equine Assisted Therapy (EAT) for     military veterans diagnosed with Post-Traumatic Stress Disorder. Data will be collected     through tests and questionnaires, and follow-up interviews with participants. It is expected     that after a series of 10 EAT sessions, the social, emotional and psychological well-being of     participants will be improved and PTSD symptoms alleviated.   "
35833|NCT02816762|"     Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to     conventional drug treatment on the albuminuria in patients with diabetic nephropathy and     obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP treatment     on the estimated glomerular filtration rate of patients with diabetic nephropathy and OSA;     determine the additional longterm CPAP effect on glycemic control, insulin resistance, lipid     profile, health-related quality of life and biomarkers of cardiac function, inflammation,     oxidative stress, sympathetic tone and appetite-regulating hormones in patients with diabetic     nephropathy and OSA; and to identify the subgroup of patients with diabetic nephropathy and     OSA in which 12 months of treatment with CPAP achieve a more pronounced reduction in     albuminuria.      Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional     treatment-controlled trial of 12 months of duration.      Subjects will randomize to conventional dietary and pharmacological treatment or conventional     dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study     subjects: Subjects 18 to 80 years with overweight or obesity and a clinical diagnosis of     diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and an estimated     glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses of     angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or     anti-aldosterone drugs in the last four weeks. Efficacy variables:      urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated     hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and     QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin     I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers     (inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane],     endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y] and     appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires: short     form (SF)-12, EuroQoL and iPAQ.   "
35834|NCT02816749|"     This is a prospective study of participants with diabetic foot ulcers who will receive either     maggot debridement therapy (MDT) or conventional dressing therapy (CDT). Wound healing time     is the main outcome measure to compare the clinical efficacy of these two therapies. The     investigators developed a hypothesis that MDT could achieve remarkable shorter time and     better healing rate for wound closure when compared with CDT.   "
35835|NCT02816736|"     The primary objective of the study is to determine whether, in patients with symptomatic,     advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696     for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect     hemodynamic and clinical status, compared to treatment with valsartan.   "
35836|NCT02816723|"     Evidence shows the positive effects of Brain Health & Wellness classes in younger     individuals. The proposed study investigates the usefulness of these classes in older     Veterans aged 50-85. We hope to show that such classes can lead to improvements in both     thinking skills as well as stress levels.   "
35837|NCT02816710|"     To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment     of vitreous hemorrhage (VH).   "
35838|NCT02816697|"     The proposed study plans to adapt and study the implementation and effectiveness of     integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the     thoracic oncology setting using mixed methods.   "
35839|NCT02816684|"     Among children, social anxiety is a common, severe and chronic disorder. Social Effectiveness     Therapy for Children (SET-C) is an empirically supported treatment with significant potential     to impact the lives of children with this severe and chronic disorder. The proposed     Pegasys-VR™ system will distinctly enhance its utility, as it will allow dissemination to a     broad variety of clinical settings including schools as well as traditional outpatient     clinics. Its use for the treatment of social skills deficits will offer a superior solution     for mental health personnel, solving many of the resource and logistic barriers that they     currently face. The final product will address cost and practical issues by disseminating an     empirically-supported treatment that was rigorously built and tested. Using VE will make the     traditional social skills therapy programs program cost-effective and patient-centric,     allowing even clinicians with little background/training in behavior therapy to have tools     not typically available to them.   "
35840|NCT02816671|"     The primary purpose of this prospective, open-label, multi-center observational registry with     all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world     setting in thoracic surgical procedures. Procedures may be open or video assisted thoracic     surgery (VATS) including robotic surgical cases. Clinicians will provide objective and     subjective evaluation of the use of the stapler in their procedures.   "
35841|NCT02816658|"     Inguinal hernia repair is one of the most commonly performed general surgery operations.     However, to date, the ideal surgical approach for inguinal hernia surgery. The investigators     therefore, propose a randomized controlled trial comparing laparoscopic inguinal hernia     surgery repair to robotic inguinal hernia repair surgery.      The investigators hypothesize that the robotic approach to inguinal hernia repair will result     in improved post-operative outcomes compared to traditional laparoscopic inguinal hernia     repairs.      Specific Aim #1: To determine if the robotic approach will result in a significant reduction     in postoperative pain and earlier return to full function when compared to a laparoscopic     inguinal hernia repair.      Specific Aim #2: To perform a cost analysis to determine the financial implications of     performing a robotic versus a laparoscopic inguinal hernia repair.      Specific Aim #3: To determine the effect of surgeon reported ergonomics when performing     laparoscopic versus robotic inguinal hernia repairs.      Specific Aim #4: Evaluate the long term hernia recurrence rates associated with laparoscopic     versus robotic inguinal hernia repairs.   "
35842|NCT02816645|"     The study of non-invasive and reliable biomarkers to track progression of Parkinson's disease     (PD) is essential while disease-modifying treatments are being developed. Many clinical     biological or imaging biomarkers have been tested but no gold standard has been found as of     yet. Among these, Magnetic Resonance Imaging (MRI) relaxometry using R2* measurement (R2* =     1/T2*), which is a validated marker for estimating brain iron concentration, appears to be an     attractive technique because its safety, rapidly measured in clinical conditions and its ease     to ensure individual longitudinal follow-up. Current data of cross sectional studies of R2*,     which have shown an iron increase in Substantia Nigra (SN), led to suppose that it could be a     biomarker of disease vulnerability. Recently, the investigators have conducted the first     longitudinal follow-up of R2* (1.5 T MRI), which showed a rapid R2* increase in both parts of     the SN and in the caudal putamen. We propose, here, a multicenter prospective study of     one-year cohort follow-up of R2* variations (ΔR2*) in three regions of interest (ROIs) (the     SN, the Ventral Tegmental Area (VTA) and the Putamen) of 160 patients with PD, using a 3     Tesla MRI, to evaluate the potential interest of R2* as a biomarker of disease progression.     The variation of R2* (ΔR2*) will be correlated with clinical markers of disease progress,     non-motor symptoms. 80 healthy controls subjects will also be included to assess the effect     of aging on cerebral physiological iron levels.   "
35843|NCT02816632|"     The purpose of this research is to identify and probe the neural networks involved in     feedback processing. It aims at translating this knowledge to clinical populations in which     this network is disrupted or compromised.      It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of     feedback processing on decision making using different types of feedback (neutral, social and     monetary) presented either infra- or supra-laminary and 2) probing the role of one structure,     the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy     subjects. The interventional part consists in the administration of Galvanic Vestibular     Stimulation (GVS), which by means of small intensity currents activates the vestibular organs     and subsequently vestibular-related brain areas. GVS will be delivered to healthy     participants engaged in behavioural tasks requiring the processing of feedbacks of different     nature (e.g. social or monetary feedbacks)   "
35844|NCT02816619|"     There is growing interest for physical activity in Parkinson's disease in order to improve     mobility and function of these patients. It seems from previous studies that difficulty,     intensity and specificity of physical exercises are important parameters conditioning the     effect of physical activity on cerebral plasticity and clinical improvement.      Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity     coaching program, including scheduled and frequent follow up associated with progressive     readaptation of exercise intensity depending on individual performances (during 3 months),     versus free practice of physical activity in Parkinson's disease.   "
35845|NCT02816606|"     Following recent advances in the understanding of successful anterior cruciate ligament (ACL)     reconstruction, three important factors have been identified: femoral tunnel positioning,     femoral tunnel aperture shape, and native remnant preservation. Accordingly, the researchers     have adapted their technique to address these goals. This study is designed to assess the     feasibility of evaluating these graft characteristics, on post-operative imaging, and the     ability to show potential improvements with the researchers' technical changes. The study     plans to use three-dimensional computer tomography (3D-CT) and magnetic resonance imaging     (MRI) to assess these properties and the integration of the graft. In addition, the     researchers will use their routine functional scores to monitor the patients' outcome. If     successful, the research team hope to set-up a randomised control trial of this alternative     technique versus conventional methods with assessment through the same imaging mediums and     clinical follow-up.   "
35846|NCT02816593|"     To evaluate the efficacy, safety and impact on quality of life related to oral health of home     and office tooth whitening techniques in young individuals.   "
35847|NCT02816580|"     Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of     age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying     frailty and implementing preventive measures can help to slow cognitive decline. Screening     and treating frailty seem to be a good start towards preventing dependency.      On the premise that this frailty is the result of more pronounced tissue alterations in     certain elderly subjects, assessment of post-translational modification derived products     (PTMDP) represents an innovative evaluation method. These include advanced glycation     end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the     intensity of these modifications increases with ageing, and assessing the products resulting     from these alterations could show the existence of differences according to frailty status.     This would make it possible to adapt treatment accordingly in elderly subjects.   "
35848|NCT02816567|"     The objective of the study is to describe factors influencing abdominal compliance during     laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is     randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance     is measured by pressure/volume relationship.   "
35849|NCT02816554|"     A dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX-     VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in     Vietnamese children, aged 9 to 24 months to assess the safety and immunogenicity. Two hundred     children are enrolled and randomly assigned into 4 groups (50 children/group), each of which     receive 2 doses of study / control vaccine subcutaneously, at 10-12 days interval. Safety     issues included immediate reaction at the site of injection and systemic reaction within 30     min of administration, solicited and unsolicited adverse events occurs from the first dose to     30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood     cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing     antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).   "
35850|NCT02816541|"     The Pilates Method (PM) has been widely used in the daily practice of many professionals. It     is well known that anticipatory postural adjustments (APAs) have a strong relation with the     improvement in performance through motor control improvement. However, no studies have     investigate the PM exercises performed with pelvis in different positions on the improvement     of performance, APAs and these influences on motor control. This study aims to compare the     effects of practicing a single session of Pilates-based therapeutic exercises with posterior     pelvic tilt and neutral position of the pelvis on the APAs of elderly subjects.   "
35851|NCT02816528|"     France is a country strong consumer of antibiotics in Europe, specially in primary care.      Outpatient antibiotic use represents around 90% of total antibiotic use and prescriptions     come mainly from general practitioners. A literature review of antibiotic stewardship in     primary care show that there is no evaluation of interest of giving information about     consumption of antibiotics and bacterial resistance to general practitioners. The objective     of this study is to demonstrate that practitioners implicated in the followed of consumption     of antibiotics and bacterial resistance around their geographical area of practice could     change and improve their practices in good use of antibiotics.   "
35852|NCT02816515|"     This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy     (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin     containing mouthwash given prophylactically for the prevention of mucositis in patients     before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients     with mucositis compared to standard treatment should be investigated. The study doesn't     intervene with routine treatment strategy.   "
36927|NCT02802345|"     To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in     Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.   "
35853|NCT02816502|"     This study investigates the clinical and neural effects of stress management skill building     programs for young adults with childhood adversity. The investigators will recruit a total of     60 young adults (21-35 years old) who will be randomized into two different stress management     skill building programs, both of which are 8 weeks long. MRI and psychological assessments     will be acquired from all subjects before and after the intervention programs in order to     investigate changes in clinical symptoms (such as depression, anxiety and stress) and     hippocampus structure and function as well as other neural changes.   "
35854|NCT02816489|"     Labial alveolar bone thickness and apical root resorption changes associated with     self-ligating versus conventional brackets.      The aim of this study will be to compare labial alveolar bone thickness and apical root     resorption changes associated with self-ligating versus conventional brackets.   "
35855|NCT02816476|"     This is a Phase II, single-arm, multicentre study of Daratumumab (16mg/kg IV route) in adult     patients with Light-Chain (AL) Amyloidosis who are not in VGPR or better after previous     treatment. A sample size of 40 patients who meet all eligibility criteria will be enrolled to     receive study treatment. Patients will receive treatment until either disease progression or     toxicity has occurred with a maximum planned of six 28-day cycles.      Daratumumab will be administrated every week for the first 2 cycles then. every 2 weeks from     cycle 3 through cycle 6.      Patients will also receive best supportive care (BSC) to mitigate Daratumumab side-effects,     and to address underlying Amyloidosis, including blood product transfusions, antimicrobials,     and (as appropriate) growth factors including granulocyte colony-stimulating factors for     neutropenia, erythropoietin for anaemia, and/or transfusions for thrombocytopenia   "
35856|NCT02816463|"     The purpose of this study is to determine whether the leak pressure of the recently     introduced laryngeal mask airway, Ambu AuraGain performs superior to the established     laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak     pressure is the pressure at which a gas leaks around the airway, which is a key marker of     efficacy and safety of its use; a higher leak pressure suggests a better seal between the     artificial airway and patient's airway.   "
35857|NCT02816450|"     The aim of this study is to determine the influence of changes in water intake on changes in     cognitive function among preadolescent children. Further, the proposed work will determine     the relationship between urinary markers of hydration process and cognitive function. We     hypothesize that an increase in water intake will result in greater cognitive performance. In     addition, improvements in hydration demonstrated by lower urine concentration will be     correlated with greater cognitive performance.   "
35858|NCT02816437|"     This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT)     can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ     transplant recipients with a history of one or more MDRO infections.   "
35859|NCT02816424|"     Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine     recommend that teen health providers screen for sexual risk behaviors and provide education     and counseling to those at risk, there are currently no specific guidelines or protocols     available to guide such practices, nor have there been any rigorous evaluations of efficacy.     Preventing teen pregnancy through brief intervention in primary care holds the promise to     have a significant public health impact and reduce health disparities by engaging, educating,     and motivating the majority of teens who visit a primary care setting each year. In the     current study, we seek to rigorously evaluate the impact of brief intervention vs.     informational control on unprotected sexual intercourse among teens with past year     unprotected sex at two primary care clinics serving predominately underserved, minority     populations in New Mexico. The target population for the current study will be 1350 male and     female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the     Albuquerque Job Corps Wellness Center. Extensive formative work involving the study     population will be conducted prior to the trial to refine the motivational interviewing-based     brief intervention. Eligible youth will be randomly assigned to brief intervention or an     informational control condition, in addition to regularly offered medically-based     contraception consultation and prescription services. Follow-ups at 3- and 9- months will     compare rates of unprotected sex and acceptance of long-acting reversible contraceptives.     Brief education and counseling interventions could be feasibly implemented during the greater     than eight preventive and acute primary care visits that the average US adolescent attends     during their teen years. Such an approach could conserve valuable resources required by more     intensive interventions for nonresponsive teens with greater need. Furthermore, social     determinants of health, such as poverty and race, that may reduce access to more extensive     psychosocial interventions, are less likely to prevent access to primary care, increasing     health equity.   "
35860|NCT02816411|"     In this study the investigators utilized protein supplementation over an 8-day period     following eccentric exercise-induced muscle damage in order to test the initial hypotheses :     i) protein supplementation after exercise-induced muscle injury affects exercise-induced     aseptic inflammation and muscle performance.   "
35861|NCT02816398|"     Feasibility clinical study to evaluate the safety and effectiveness of the catheter system     for the percutaneous creation of an arteriovenous fistula for patients with end stage renal     disease requiring dialysis access.   "
35862|NCT02816385|"     Myocardial protection is a fundamental element for the safety of patients when performing     cardiac surgery. For this purpose, cardioplegia were rapidly established in clinical practice     to protect the myocardium when performing aortic clamp.      Cardioplegia are procedures to stop the contraction of myocardium. It is usually achieved     with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled     perfusate). The composition of the cardioplegic solutions and their method of administration     continuously changed over the years.      At the present date, cold blood cardioplegias are performed in the investigator's center. The     investigators regularly use two modes of administration: either by an antegrade path     (injection in the coronary arteries), or a retrograde one (injection in the venous system).     At present, there are no elements supporting the superiority or inferiority of one path     compared to another. The difficulty lies within a clear estimation of the contractility state     of the ventricular cardiac muscle.      Technological developments in recent years provided a solution to this problem. The analysis     of the pressure/volume curves generated by a ventricle allows an accurate quantification of     the myocardial contractility. This requires the use of conductance catheters to accurately     measure the ventricular volume and the ventricular pressure. The absolute ventricular     contractility is then deduced with the help of a software.      The investigators intend to use this pressure-volume loops, obtained with conductance     catheters, to compare the contractility of the right heart ventricle after antegrade vs     retrograde cardioplegia.   "
36046|NCT02813967|"     This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older     with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with     radiotherapy or radiotherapy alone.The primary endpoint was overall survival.   "
35863|NCT02816372|"     Despite the use of protective ventilation, neuromuscular blocking agent and prone position,     ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in     randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal     volume over respiratory system compliance) has recently been strongly associated with ARDS     mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit.     While extracorporeal CO2 removal technique are currently under investigation in association     with tidal volume reduction   "
35864|NCT02816359|"     Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress     SyndromeARDS patients in order to set ventilator settings. There might be variations of the     measured value according to the patient position (0° vs 30°) at the time of measurements.   "
35865|NCT02816346|"     Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot     of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for     all S. sonnei vaccine candidates. An adaptable dosing plan will be used to determine the dose     of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.   "
35866|NCT02816333|"     Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B     aortic dissection who meet all inclusion and exclusion criteria will be included.      Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be     followed clinically for 12 months after the procedure. CT will be performed at 12 months.   "
35867|NCT02816320|"     In a retrospective cross-sectional study, investigators aimed to valid the variables employed     to generate standardized mortality ratio from hospital administrative databases. For this     purpose, investigators have compared those variables collected in administrative databases     with the information available in patient medical record.   "
35868|NCT02816307|"     Infective endocarditis remains a serious disease that requires fast and specialized support     in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy     diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for     markers of inflammatory and tumoral diseases, should increase the number of positive     etiological diagnosis of culture-negative samples.      Secondly, because of the seriousness of the disease, the investigators were led to develop a     new score: score for admission. This score, realized in less than 4 hours from the admission     of the suspected patient with endocarditis, should allow for immediate probabilistic     antibiotic treatment after completion of the diagnostic kit. The modified Duke score give its     results in 4 to 7 days. With the score of admission thus diagnostic processes are accelerated     and, where appropriate, empirical antibiotic therapy started.      Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological     identification of endocarditis.      Secondary: Validate the admission score compared to the modified Duke score.   "
35869|NCT02816294|"     Housing Prescriptions as Health Care is a research project studying the effects of an     innovative intervention that combines services across the health, housing, social and legal     service sectors in order to improve housing stability and child health outcomes among     participants. The housing intervention developed for this study specifically addresses issues     including families who are: paying more than 50 percent of income on rent or utilities,     moving frequently, experiencing homelessness, but are not eligible for shelter through the     Department of Housing and Community Development's Emergency Assistance program, or were     unable to pay rent on time in the past year. This research explores how coordinated and     comprehensive housing services offered through intensive case management improves housing     stability and health outcomes for families of young children.   "
35870|NCT02816281|"     A retrospective cross-sectional analytic study to evaluation and identification of the     reasons about Scheduled elective surgical case cancellation in Siriraj Hospital, reason of     cancellation will be extracted from hospital medical record of each case, reviewed and     divided into 2 groups, with SiPAC and without SiPAC consultation. Primary outcomes are the     incidence of cancelled case and causes of the cancellation and secondary outcome that will be     identified for areas of improvement.   "
35871|NCT02816268|"     The investigators prospectively investigate the differences between contact-force guided     pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with     paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant     conduction, procedural and clinical outcome.   "
35872|NCT02816255|"     Subjects will all have a two week baseline period in which they will use a nasal mask using     an air view CPAP machine (which records all data). After the two week period all will switch     to a full face mask with half using the same CPAP pressure and half with a new a CPAP     pressure derived from our formula for the final two weeks.   "
35873|NCT02816242|"     effect of concept map in teaching critical thinking was done with randomized study   "
35874|NCT02816229|"     Massive haemoptysis is a life-threatening condition which is commonly seen in patients who     have previously had pulmonary tuberculosis. Various treatment options exist such as bronchial     artery embolisation (BAE) or surgical resection of the affect lung region. However, BAE is     not considered curative as there is often recurrence of haemoptysis. Furthermore, not all     patients will be deemed suitable for surgical resection, leaving them with very few treatment     options. A possible alternative intervention is the insertion of an endobronchial valve     (EBV). It is speculated that blood will collect distal to the one way valve and a thrombus     will be formed. There is currently no data describing the use of EBV for the treatment of     massive haemoptysis. This RCT aims to explore the use and efficacy of EBV in the management     of massive haemoptysis.   "
35875|NCT02816216|"     This project will fully develop and preliminarily validate CampAir, an empirically-based     dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with     uncontrolled asthma to learn how to manage their illness and improve their asthma control. In     addition to developing a highly novel product for adolescents with asthma, the research     proposed for this project will address unique scientific questions. Despite the high asthma     prevalence among adolescents, few interventions have specifically targeted adolescents. This     study is innovative in that it is among the few to focus on adolescents, who are often     overlooked by the healthcare system. This research will assess factors associated with     successful implementation of CampAir, thereby providing new information regarding how     e-health interventions can be effectively developed and implemented for use with adolescents     with asthma.   "
35876|NCT02816203|"     Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible     for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of     500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours     after delivery.      In clinical practice, if after giving birth, the placenta is not expelled naturally, an     active management should be triggered. After obstetric maneuvers therapeutic, options begin     with uterotonic treatments before considering invasive treatments such as embolization,     vessel ligation and hysterectomy. However, the morbidity associated with these techniques and     the desire to preserve fertility mean that new therapeutic solutions have been conceived,     which has recently led to the development of an innovative intrauterine hemostasis medical     device : a hemostatic intrauterine suction cup.      Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this     biomedical research, the study of a new medical device. Our hypothesis is that the uterine     walls will append to the walls of the suction cup after the latter is put under vacuum. The     actuation of the suction cup will lead to the aspiration of all sides of the uterus.   "
35877|NCT02816190|"     Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF     ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric     capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned     patients will be included in the study with usual monitoring (i.e. respiratory system basic     mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will     be collected during all prone position sessions.   "
35878|NCT02816177|"     Telemedicine-based care provides remote health and social care to maintain people's autonomy     and increase their quality of life. The rapidly aging population has come with a significant     increase in the prevalence of chronic diseases and their effects, and thus the need for     increased care and welfare.      This solutions give a new opportunity for diagnosis, treatment, education, and     rehabilitation, and make it possible to monitor patients with a number of chronic diseases.     It also reduces socioeconomic disparity with regard to access to care and gives equal chances     to patients from urban and rural areas.      This a randomized trial of telemedicine versus usual care alone to reduce hospitalization and     emergency hospital admissions for Nursing Home Residents .      After an initial assessment , each participant is monitored by teleconsultation on six     occasions over 12 months. Patients with usual care have an initial and a 12 months     assessments.   "
35879|NCT02816164|"     In patients with early-stage breast cancer, chemotherapy has substantially improved survival     rates. Improvements in outcomes, however, are compromised by the considerable toxicities     associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence     of abnormally few white blood cells, leading to increase susceptibility to infection and can     require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile     neutropenia (FN) can also be associated with treatment delays and dose reductions,     potentially compromising treatment efficacy. Patients can receive medication to reduce the     risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since     there is genuine uncertainty among healthcare professionals as to which administration     schedule of Neupogen is the best for patients, the investigators are performing a randomized     study for which patients will receive either 5, 7 or 10 days of Neupogen. Neupogen can cost     approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment,     this can cost $16,000 compared to a 5 day treatment which would cost half this. In addition     to cost savings, many patients are not able to give themselves injections on a daily basis     and require nursing resources which are utilized at high cost. This study will use an oral     consent model to compare 5, 7 and 10 days of Neupogen to evaluate rates of febrile     neutropenia and hospitalization.   "
35880|NCT02816151|"     Detrusor hyperactivity is an urodynamic observation defined by involuntary detrusor     contractions during the vesical filling. Within neurological bladders childs, especially     related to spinal dysraphisms, this hyperactivity, associated or not with vesical compliance     disorders, can involve a urinary incontinence obstructing social integration and possibly     vesical pressure rise in the intra- potentially generating the high urinary tract lesions.     Anticholinergic drugs possibly associated with a vesical draining constitute the treatment of     first intention. In approximately 15 to 20% of the cases, intradetrusor iterative injections     of type A Botulinum Toxin are proposed fault of satisfactory results. Largely used according     to the European consensus of 2008 without AM, actual studies remain realized on small numbers     with low level of proof. Posology remains discussed between pharmaceutical laboratories     (derivative of the effective maximum amount per adult kg of weight) and weaker amounts used     with clinical results.   "
35881|NCT02816138|"     Late-life depression is characterized by both affective (mood) symptoms and cognitive     deficits. There is currently no intervention that may provide consistent benefits to both     mood and cognitive performance. Agonist activity at the nicotinic acetylcholine receptors via     transdermal nicotine patches may provide benefit to both mood and cognition, working through     nicotine's effects on brain neural networks, specifically the cognitive control network and     default mode network.      In this initial pilot project, the investigators will test this hypotheses in 15 nonsmoking     depressed elders with subjective cognitive impairment. Following baseline neuroimaging and     cognitive testing, participants will receive 12 weeks of open-label transdermal nicotine.     Afterwards, participants will repeat neuroimaging and cognitive assessments.   "
35882|NCT02816125|"     Healthy premenopausal women were enrolled in a diet intervention study that examined the     effect of a combination EPA/DHA supplement on risk factors associated with breast cancer. In     a randomized cross-over design, women consumed their habitual diet with a supplement for     three menstrual cycles, had three cycles of wash-out and then consumed a low-fat diet with     the same supplement. Blood, urine and nipple aspirate fluid were collected periodically over     the 10 month protocol and analyzed for biomarkers associated with supplementation and future     risk of breast cancer.   "
35906|NCT02815813|"     This is a four year project evaluating the effectiveness of a group-based lifestyle     intervention (PeerFIT) supported by mHealth technology and social media compared to Basic     Education in fitness and nutrition supported by a wearable Activity Tracking device (BEAT) in     achieving clinically significant improvements in weight loss and cardiorespiratory fitness in     young adults with SMI.   "
35883|NCT02816112|"     Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy     regimen in patients with resected early stage breast cancer. TC chemotherapy can cause     febrile neutropenia (FN) which can be serious and associated with treatment delays and dose     reductions, thereby compromising treatment efficacy. To reduce the risk of     chemotherapy-induced FN,TC is administered with either one of two highly effective standard     treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte     colony-stimulating factor (G-CSF). However, there are considerable cost differences between     these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment     while oral ciprofloxacin costs about $100.      The investigators have therefore been performing a feasibility study to explore whether the     integrated consent model involving oral consent is feasible in practice; and whether it can     be used to increase the number of physicians and patients who take part in clinical trials.     This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the     investigators are therefore now performing a definitive study comparing G-CSF with     ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically     important endpoints of hospitalizations and febrile neutropenia rates.   "
35884|NCT02816099|"     In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is     slowed down.      ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that     regulates cholesterol transfer in the body.      The aim of this study is to determine whether it is possible to correct apoC1 function by     improving glycaemic balance.      240 persons will be recruited in this study and allocated to one of two groups:        -  160 Type-1 diabetes patients with uncontrolled diabetes:             -  4 additional blood samples will be taken at the time of the systematic biological               examination at inclusion and then again 3 months later.        -  80 control subjects with normal lipids and normal glycaemia balance will be included in          the study following the results of the biological assays.             -  4 blood samples will be taken at the time of inclusion.   "
35885|NCT02816086|"     Suboptimal use of medications among geriatric patients is well-known problem and leads to     medication errors, re-hospitalizations and death. By using a randomized controlled trial     (RCT) design the investigators aim to explore a new inter-professional working structure. The     working structure is based on the scientifically and clinically acknowledged integrated     medicines management (IMM) model. The overall aim of the study is to explore the effect of     the new working structure on the composite endpoint re-hospitalization + visit to an     emergency department during 12 months after hospital discharge.   "
35886|NCT02816073|"     A randomized study to assess the safety and efficacy of single-session pan-retinal     photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic     retinopathy (PDR) - 1,700 shots vs 2,500 shots   "
35887|NCT02816060|"     Background: There is evidence linking conditioned pain modulation (CPM) deficiency with     musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and     irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain     and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain     there is no activation of CPM.      Objectives: The purpose of this study is to measure the CPM response and determine whether     neural tensioner exercise in patients with chronic neck pain is effective in the improvement     of neck pain intensity, neck disability and cervical range of motion.      Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain     will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the     sham technique (ST) group.      Individuals will be included in the study if they meet the following inclusion criteria: aged     18-65 years, neck pain perceived in the posterior region of the cervical spine, from the     superior nuchal line to the first thoracic spinous process with more than 12 weeks of     evolution and without radicular symptoms radiated to the head. Neck pain intensity with a     visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion     will be measured pre and port intervention.   "
35888|NCT02816047|"     Background: The wearable cardioverter defibrillator (WCD) is an established treatment option     for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF),     either in whom this risk may only be temporarily present, or in patients at high risk for     sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator     (ICD is currently not possible for other reasons (infection, recent MI <40days, recent     PCI/CABG < 3months etc.).      Methods: Comprehensive registry including all patients in Austria who received a WCD in     2010-2016.   "
35889|NCT02816034|"     The purpose of this study is to investigate if individuals with a cannabis use disorder have     an impaired cerebellar function by assessing possible alterations to their implicit     adaptation during a visuomotor rotation task.   "
35890|NCT02816021|"     The goal of this clinical research study is to learn if oral azacitidine (CC-486) and     pembrolizumab (MK-3475) can help to control melanoma. The safety of this drug combination     will also be studied.   "
35891|NCT02816008|"     Cognitive rehabilitation is defined as a systematic functionally oriented intervention of     therapeutic cognitive activities based on the assessment and understanding of patient's brain     behavior deficits. This project focuses on restoring cognitive functions in order to     understand the underlying deficits in the patient's brain by developing integrated cognitive     rehabilitation scenarios in virtual reality that combine memory, attention and problem     solving training with context specific motor movements.   "
35892|NCT02815995|"     The goal of this clinical research study is to learn if the combination of durvalumab and     tremelimumab can help to control sarcoma. The safety of this drug combination will also be     studied.   "
35893|NCT02815982|"     This purpose of this pilot study is to investigate the feasibility of and optimal time post     cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T),     as well as assess its preliminary efficacy on specific child health behaviors. The study will     also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC     (standard care).   "
35894|NCT02815969|"     This is an observational and exploratory study. Participants will be asked for a blood     collection and a 24- hour collection of urine. The indol profile and levels of catecholamine     and metabolites in PRP, as well as in 24- hour collection of urine will be measured with     LC-MS/MS and analyzed.   "
35950|NCT02815241|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35895|NCT02815956|"     Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of     management after colorectal surgery because of an increase of the morbidity rate or of the     rate of early rehospitalization after discharge.      Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will     experiment POI.      A new approach during preoperative era, using mastication or preoperative physical activity,     has been proposed to improve postoperative course. This leads to a vagal activation (action     especially on upper GI).      Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower     GI.      The aim of this study was to assess the efficacy and the feasibility of PTNS during     perioperative course, to prevent POI with respect with placebo.   "
35896|NCT02815943|"     Bariatric surgery procedures have now been firmly demonstrated to lead to significant     improvement and even, in many cases, complete reversal of abnormal glucose homeostasis in     type 2 diabetes (T2D). Various surgery procedures are can be performed to induce weight loss.     The most striking anti-diabetic effects are observed with biliopancreatic diversion with     duodenal switch (BPD-DS), followed by Roux-in-Y gastric bypass (RYGB) and sleeve gastrectomy     (SG). The first two procedures induce both a restriction of energy intake and a low     absorption of dietary fatty acids while the latter exclusively targets energy intake     restriction. The investigator and others have shown that improvement of T2D occurs within     days after BPD-DS or RYGB in the vast majority of patients, prior to any significant weight     loss. This very rapid metabolic recovery is explained by a normalization of β-cell function     after meal challenges and ameliorated hepatic insulin sensitivity. The investigator and     others have shown that these acute anti-diabetic effects are mostly recapitulated by matched     caloric restriction, independent of changes in gastrointestinal hormones, showing the     importance of gastrointestinal-derived energy fluxes for acute diabetes control. Muscle     insulin sensitivity, on the other hand, improves more slowly in association with weight loss,     demonstrating the heterogeneous metabolic response of the various organs to BPD-DS. Some     preliminary studies also demonstrate a rapid reduction of NEFA levels and production rate     upon i.v. administration of lipids during euglycemic hyperinsulinemic clamps. This very rapid     improvement in NEFA tolerance strongly suggests that adipose tissue storage of circulating     fatty acids also improves very rapidly, prior to any significant weight loss, after BPD-DS.     It may also suggest an acceleration of oxidative fatty acid metabolism in organs such as the     liver, the heart and/or skeletal muscles. Studies of the rapid metabolic changes after     bariatric surgery conducted thus far rapidly improved the understanding of the fundamental     pathogenic defects of T2D. However, much remains to be understood about the acute changes in     gastrointestinal-derived metabolic fluxes, organ-specific metabolic responses to bariatric     surgery and their relationship with the reversal of T2D. Using in vivo methodological     approaches, the investigator proposes to investigate the early organ-specific changes in     dietary fatty acid metabolism in response to BPD-DS vs. SG and their relation to improved     systemic changes in glucose homeostasis, insulin sensitivity and β-cell function in patients     with T2D.   "
35897|NCT02815930|"     High cost users (HCUs) are a small group of patients who use a disproportionate amount of     health care resources. This study is a retrospective population-based matched cohort analysis     of newly incident senior High Cost Users (HCUs) defined as Ontarians aged 66 years or older     in the top 5% of healthcare expenditure users in fiscal year 2013 (FY2013). The study     objectives are to characterize and contrast Ontario senior HCUs to non-HCUs based on their     demographics, co-morbidities, medication use, health service utilization, healthcare     expenditures, medication costs and clinical outcomes, and to determine the relative     contribution of medications to senior HCUs expenditures   "
35898|NCT02815917|"     Preclinical work suggests that D3 dopamine receptors may be important in the study of the     pathophysiology of affective disorders, psychotic disorders and addiction. D3 receptors may     also play a role in dystonia, Parkinson's disease and response to treatment of these     disorders. However, there has been a lack of specific radioligands for imaging D3 receptors.     This proposed protocol will evaluate the uptake of [18F]FTP as a more specific in vivo     measure of D3 receptor binding in the brain in healthy volunteers subjects after injection of     lorazepam vs placebo, and in cocaine-dependent subjects. Test-retest scans will evaluate the     variability of [18F]FTP uptake measures in both healthy volunteer subjects and     cocaine-dependent subjects.   "
35899|NCT02815904|"     The role of physiotherapy interventions in treatment of high risk infants has not been     established even after a number of studies. The high risk infants are prone to developmental     delays and early intervention is most effective for them owing to the plasticity of brain in     early infancy. Yakson is one among the most effective and safe methods of tactile stimulation     for preterm neonates. Tactile and kinesthetic stimulation techniques have been proved to be     effective but there is no standardized protocol. The present study will try to investigate     the efficacy of Yakson touch in combination with kinesthetic stimulation on the development     of high risk neonates against conventional handling which will include developmental     positioning and Kangaroo mother care.   "
35900|NCT02815891|"     TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFL     or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients     with NAFL or NASH within academic and community real-world practices in order to assess the     safety and effectiveness of current and future therapies.   "
35901|NCT02815878|"     This project is an adaptation trial, testing the efficacy of an evidence-based community     wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in a     sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury,     post-polio syndrome and muscular dystrophy.   "
35902|NCT02815865|"     The investigators intend to conduct a randomized clinical trial comparing 3 methods of     induction of labor in term primiparous women with singleton. First group will be women     induced with Foley catheter and pitocin, second group Foley catheter and vaginal dinoprostone     and third group will be induced with vaginal dinoprostone alone. The investigators compare     time for induction to delivery and way of delivery.   "
35903|NCT02815852|"     The purpose of this study is to review retrospectively cases of breast cancer of the centers     belonging to the BREST UNIT Tuscany North-West Wide Area and compare the imaging     characteristics (ultrasound, mammography and mammary MRI if available) of breast cancer with     the corresponding histological reports and assess whether in women <40 years the typical     imaging presentation pattern of malignancies observed in women> 40 years are confirmed.   "
35904|NCT02815839|"     The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic     and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.   "
35905|NCT02815826|"     The purpose of this study was to evaluate the influence of 16 weeks of progressive barefoot     running training on impact force and muscle activation in habitual shod runners. Habitual     shod runners were tested barefoot (BF) and shod (SH), before and after 16 weeks of     progressive barefoot running training. Tests consisted of running on instrumented treadmill     at 9 km/h, for 10 minutes in each experimental condition. Nine data acquisitions (10 s) of     vertical ground reaction force (VGRF) and electromyographic (EMG) signal were conducted in     each experimental condition, for each test.   "
35951|NCT02815228|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35907|NCT02815800|"     ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient     acting alongside vitamin B2. It is proposed in patients with visual problems. Based on     clinical and experimental data, the investigators propose a pilot open study in order to test     the efficacy of Ethnodyne visio in patients with Parkinson 's disease (PD). The hypothesis     is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will     be evaluated before and after 3 months of add on treatment by Ethnodyne visio.   "
35908|NCT02815787|"     The purpose of the study is to investigate the potential interaction between SP2086 and     Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers     respectively.   "
35909|NCT02815774|"     The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency     Patients.   "
35910|NCT02815761|"     Chronic obstructive pulmonary disease (COPD) is a common disease worldwide with a high burden     on healthcare resources. The prevalence of COPD varied from 11.4 to 26.1% according to a     recent multi-city population study using spirometry. In Hong Kong (HK), the prevalence rates     of COPD in the elderly population aged ≥60 years were 25.9% and 12.4% based on the     spirometric definition of forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC)     ratio <70% and the lower limit of normal of the FEV1/FVC respectively. In 2005, the crude     mortality rate of COPD was 29.1/100 000, while the crude hospitalization rate was 193/100,000     in HK. In HK, COPD ranked second as a respiratory cause for hospitalization. In those 75     years or older, the hospitalization rate for COPD was as high as 2,225/100,000. The economic     burden of COPD on the society is enormous.      Previous studies gave information on the overall morbidity, mortality and the prevalence of     COPD in HK. One study compared the management of COPD patients in HK with other countries and     found that COPD patients in HK were under-treated. No large scale study has looked into the     details of COPD patients in HK, like their co-morbidities and how they are being treated and     how these factors affect the readmission of these patients. Large prospective studies which     incorporate all the potentially relevant variables are required to refine prediction of the     important outcomes of AECOPD and thus to inform clinical decision making, for example on     escalation of care, facilitated discharge and provision of palliative care.   "
35911|NCT02815748|"     The purpose of the study is to investigate the Metabolite identification and material balance     of SP2086 in healthy adult volunteers.   "
35912|NCT02815735|"     The aim of this study is to compare the subjective performance of the comfilcon A contact     lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.   "
35913|NCT02815722|"     The purpose of the study is to investigate the potential interaction between SP2086 and     Simvastatin after the multiple oral doses treatment in healthy adult volunteers.   "
35914|NCT02815709|"     The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine     administered as needed (PRN) compared with placebo in patients with moderate to severe acute     postoperative pain after bunionectomy.   "
35915|NCT02815696|"     Degenerative disc disease (DDD) is the primary cause of low back pain. The most important     factor in the development of DDD is the vertical load force on the disc, increasing the     hydrostatic pressure and facilitating discs degenerations. One of the most common conditions     accompanying DDD is segmental instability of the spine. The pathogenesis evolves in three     phases characterized by a progressive disc dehydration and loss of the disc height.      This phenomenon can be observed in magnetic resonance imaging (T2 weighted MRI) as a decrease     of the water signal inside the intervertebral disc. It is considered as an indirect sign of     the alteration of the composition (including glycosaminoglycans) and the structure of the     intervertebral disk with, as consequence, a modification of the spine biomechanics. Animal     studies showed that disc regeneration could be enhanced by a decrease of the hydrostatic     pressure. This could be observed as a signal increase on T2 weighted MRI.      Recent quantitative MRI sequences now allow the quantification of glycosaminoglycans (GAG)     concentration inside the cartilage and in the intervertebral disc.      The actual surgical trends are in favor of an anterior (intersomatic) vertebrak fusion,     associated or not with a posterior fusion. These technics sacrifice the intervertebral disc     and change the spine biomechanics.      Based on a pilot study, the investigators believe that the conservation and even a     regeneration of the intervertebral disc is possible and allows the preservation of the spine     biomechanics.      The purpose of the study is to analyze the relations between specific MRI signals, the GAGs     concentration, and the functional outcome before and after the surgical treatment.   "
35916|NCT02815683|"     Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials,     improving lung function, exercise capacity and possibly survival and are now being adopted by     a number of centres in the Netherlands. It is important to ensure that the benefits seen in     clinical trials are in fact reflected in clinical practice and that the best use of this     early 'real world' experience is made to optimise the development and use of these novel     therapies.      Overall objective: to develop a national database to record bronchoscopic lung volume     reduction procedures for patients with emphysema. This is desirable for audit purposes but     will also be an important resource for research both in gathering data and in facilitating     collaborations.   "
35917|NCT02815670|"     The trial objective is to demonstrate the safety of idarucizumab, as assessed by the     occurence of patients with drug related adverse events (including immune reactions) and     all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in     ongoing clinical trials who require emergency surgery/urgent procedures or patients who have     life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid     reversal of the anticoalugant effect of dabigatran is needed.   "
35918|NCT02815657|"     The purpose of the study is to investigate the potential interaction between SP2086 and     Valsartan after multiple oral doses treatment in healthy adult volunteers.   "
35919|NCT02815644|"     The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover     design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin     fixed dose combination (FDC) tablet.   "
36054|NCT02813863|"     This is an open single and self-control study,planning to recruit 24 cases of healthy male     volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples     before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and     Metformin.   "
35920|NCT02815631|"     The CARDIOFLOW study compares the standard test, a pressure wire test called fractional flow     reserve (FFR), with a new method that is based on taking a detailed 3D ECG called     Cardiogoniometry (CGM).      FFR is an angiographic technique which measures the physiological significance of a coronary     stenosis and trial data has shown that basing management decisions on this data improves     prognosis. However FFR studies are expensive and invasive, whereas CGM is painless and simply     involves placing 4 sticky pads to the patient's chest / back and is similar to an ECG (heart     tracing). The investigators want to see whether we can use this new method to find out     whether treatment with coronary angioplasty would be of benefit. If so, then in the future,     clinicians could use this method (CGM) rather than pressure wire assessment (FFR). This would     have several advantages; in particular, it can be easily performed in the clinic and avoids     the need to use an expensive pressure wire.   "
35921|NCT02815618|"     Feasibility trial on the use of a hybrid optical device integrating time-resolved     near-infrared spectroscopy (TRS) and diffuse correlation spectroscopy (DCS) for measurement     of cerebral oxygen metabolism and blood flow in neonates.      The device wil be tested in four settings measuring:        1. Changes in cerebral oxygenation and haemodynamics after birth        2. precision and repeatability        3. The cerebral vaso-reactivity to arterial carbon dioxide        4. Assessment of the user-friendliness and loss of signal in routine care   "
35922|NCT02815605|"     The incidence of severe post-partum hemorrhage has been increasing in developed countries.     The reason for this is at least partially unknown. Surgical techniques, holistic treatment     protocols and strategies in blood product administration may have changed patient outcome     and, for example the incidence of transfusion related side effects. A retrospective analysis     of the whole cohort of parturients in 2009-2015 in Tampere University Hospital will be made     to assess the risk factors for severe PPH (ie. estimated blood loss more than 1500ml during     delivery) and examine the possible change in blood transfusion strategies and its effect on     bleeding (for example, implementation of massive transfusion protocol, amount of blood     products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological     agents for coagulation management, introduction of new angiological and surgical techniques     etc.) and complications, laboratory parameters and patient outcome.   "
35923|NCT02815592|"     The purpose of this this study is to administer BMS-986012 in Combination with Platinum and     Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.   "
35924|NCT02815579|"     The purpose of this study is to determine whether this multisectoral agricultural and     microcredit loan intervention improves food security, prevent antiretroviral treatment     failure, and reduce co-morbidities among people living with HIV/AIDS.   "
35925|NCT02815566|"     Design: Open-label randomised multicenter international strategic trial of older women on     combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with     HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir     alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2.     Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third     agent. Follow up of all subjects to 96 weeks.      Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years     (peri or early post menopause). .      Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar     spine at weeks 48 and 96.      Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by     high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality,     geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral     suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96.      Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree     correlating with a decreased risk of fragility fracture in aging HIV infected women.     Secondary outcomes will assess bone strength using new imaging modalities, timing of switch,     and renal health. This data will be used by health policy makers and providers to determine     the proper use of TAF/FTC in the aging HIV population.   "
35926|NCT02815553|"     Currently, surgical removal remains the main clinical treatment for cardiac tumor patients.     However, malignant tumors are hard to completely resect. Also, as thoracoscopic surgeries     induce great operation trauma, some patients cannot tolerate or do not will to take the     operation. Therefore, new methods and techniques are in urgent need.      Our center have a 12-year experience of intervention treatment for solid tumors and has     conducted several animal experiments to verify the effectiveness of transthoracic puncture     ablation and radiofrequency ablation for ventricular muscle.      The purpose of this study is to conduct new method of direct transthoracic cardiac     tumor-targeted Radiofrequency Ablation (RFA) and Laser induced Interstitial Thermotherapy     (LITT), make minimally invasive treatment plans for cardiac tumor patients, and verify the     safety and validity of intervention treatment in long term.   "
35927|NCT02815540|"     The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical     function and the autonomic nervous system in children with Dravet syndrome (DS) and     Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained     through state dispensaries or other sources. The intent is to begin to assess potential risks     and benefits of this therapy in a vulnerable patient population by characterizing the effects     of CBD on EKG findings, heart rate variability and the occurrence of seizures.   "
35928|NCT02815527|"     This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20     ventilated ICU patients. The primary endpoint of study is the feasibility to attain the     individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU admission.     Secondary endpoints include tolerance and efficacy in terms of the amino acid response in     blood.   "
35929|NCT02815514|"     The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic     valve treatment and the therapeutic consequences are documented.   "
35973|NCT02814929|"     The study includes preterm infants who are being screened for ROP between April 1,2016 and     April 30, 2017 in 69 neonatal intensive care units (NICUs) in Turkey. Infants with birth     weight (BW) of ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or     gestational age (GA) >32 weeks with an unstable clinical course are included. The incidence     of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP     development will also be evaluated.   "
35930|NCT02815501|"     Obstetric complications are common and can be responsible for maternal and foetal morbidity     and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric     complications.      Many studies have been conducted to estimate the prevalence and define the nature of     obstetric complications observed in patients with thyroid dysfunction. However, women with     obstetric complications are not systematically screened for thyroid dysfunction and no     published study has evaluated the prevalence of thyroid dysfunction in women with an     obstetric complication. As no consensus has been reached concerning systematic screening for     thyroid dysfunction in pregnant women, the identification of new high-risk populations could     possibly result in a change of clinical practice.   "
35932|NCT02815475|"     This trial will be conducted for the BBC. The aim of the project is to assess if consuming     the spice turmeric every other day, in the amount consumed in a curry, can reduce cell damage     and inflammation. The results of the project will be used to inform the TV program Trust Me     I'm a Doctor.   "
35933|NCT02815462|"     In an earlier study using electronic health records (EHR), the investigators have identified     nine factors to be significantly associated with FA risk. These nine predictors include     Furosemide intravenous 40 milligrams or more; Admissions in the past one year; Medifund     status; Frequent emergency department use; Anti-depressants treatment in past one year;     Charlson comorbidity index; End Stage Renal Failure on dialysis; Subsidized ward stay and     Geriatric patient. The investigators have combined these nine predictors into the FAM-FACE-SG     score for FA risk (defined as 3 or more inpatient admissions in the following 12 months). The     FAM-FACE-SG risk score has the advantage of being deployed in our hospital's enterprise data     repository known as Electronic Health Intelligence System or eHINTs for short, on a real-time     or near real-time basis. On a daily basis, data from multiple data sources are extracted,     transformed and loaded onto the eHINTS system. The system can be programmed to run every     midnight to provide risk scores the following morning for patients admitted the previous day.      In this trial, the intervention is to combine the FAM-FACE-SG risk score in addition to a     decision making algorithm to guide referrals to various transitional care services based on     needs assessment on nursing and function. The primary objective is to evaluate the impact of     our intervention in improving healthcare utilization (hospital readmissions, emergency     department (ED) attendances, length of stay up to 90 days post-discharge).   "
35934|NCT02815449|"     The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron     fortification can be an effective strategy to decrease this.      In the current study adding different levels of a stabilizer to iron fortified cubes and it's     effect on iron bioavailability from these cubes will be studied in the context of a Nigerian     meal in women.      24 Female subjects with low serum ferritin levels will be included in the study. The study     will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a     bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The     absorption of iron will be evaluated after every period and compared between the cubes.   "
35935|NCT02815436|"     Colorectal cancer (CRC) is one of the major global health challenges. CRC is currently the     third most common cancer in men and the second common in women worldwide, accounting for     approximately 10% of all cancers.      Randomized controlled studies have shown that CRC screening using Faecal Occult Blood Testing     (FOBT) is effective in reducing cancer mortality by 15-33%. Since yearly testing is     recommended to maintain programmatic effectiveness, longitudinal adherence is a critical     component of FOBT-based screening programs. The investigators previous study conducted in     Hong Kong showed that the rate of compliance with CRC screening was declining since the first     year of enrolment.      Nevertheless, it remains unknown whether interventions based on reminder systems could     effectively enhance longitudinal compliance with FOBT, especially among those who have     already enrolled in a CRC screening programme. Current evidence does not adequately compare     whether interactive or one-way reminder messages are superior to usual care (i.e. no     reminders).   "
35936|NCT02815423|"     The purpose of the present study is to evaluate the safety and exploratory efficacy of the     umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.   "
35937|NCT02815410|"     Prospective, open-labeled, multicenter cohort trial for validation of the role of     levetiracetam as a sensitizer of temozolomide in the treatment of newly diagnosed     glioblastoma patients.   "
35938|NCT02815397|"     Newly diagnosed histologically confirmed c-myc+ de novo DLBCL. Metformin 500 mg daily x 1     week, then 500 mg twice daily (BID) x 2 weeks, then 850 mg twice daily until 1 month after     last cycle of chemo-immunotherapy.      DA-EPOCH-R every 21 days x 4 cycles (CNS prophylaxis single or triple therapy given     intrathecally each cycle to patients deemed appropriate by treating physician).      Restage after 4 cycles with CT. Complete remission or partial remission: complete 2 more     cycles or radiation therapy (XRT) consolidation per physician. Stable or progressive disease     will go on to salvage therapy off study.   "
35974|NCT02814916|"     To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute     bacterial skin and skin structure infections in children, aged 3 months to 17 years, known or     suspected to be caused by susceptible Gram-positive organisms, including     methicillin-resistant strains of Staphylococcus aureus.   "
36055|NCT02813850|"     The purpose of this study is to assess the efficiency of the preventive oxygen therapy on the     occurrence of vaso-occlusive complications, which last more than 24 hours and require     hospitalisation, in women with sickle cell disease.   "
35939|NCT02815384|"     The research goal is to continue to add to the extensive body of peer-reviewed evidence that     demonstrates MRI may be safely performed in patients with cIEDs, after they have been     evaluated and cleared by cardiology. This study will allow the researchers to collect data     from the facilities ongoing clinical practice regarding the number and types of any adverse     clinical reactions, and also to document any changes in the implanted cardiac device that may     have occurred during the MRI scan. The researchers will also be assessing the results of the     MRI and how the imaging findings impact patient care and the clinical outcome of the patient.     This data will then be presented to the FDA and the Centers for Medicare and Medicaid     Services to further influence federal guidelines and payment structures.   "
36928|NCT02802332|"     This study will evaluate whether or not provision of a simple card (footlength card) that     allows identification of low birth weight and/or preterm babies through measurement of the     length of a baby's foot, can improve basic newborn care behaviors in rural Nepal.   "
35940|NCT02815371|"     This study evaluated whether laser acupuncture at the time of embryo transfer (following in     vitro fertilization) improves implantation rates. Patients were randomized to one of 4 groups     at the time of embryo transfer: 1) laser acupuncture, 2) needle acupuncture, 3) sham laser     acupuncture, 4) no treatment.   "
35941|NCT02815358|"     This study aims to verify the effects of a segmental stabilization exercise program on the     anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be     assessed by means of superficial electromyography focused on the registry of the onset of     multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder     ﬂexion/extension.   "
35942|NCT02815345|"     During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is     difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA),     definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was     32% . In the same study, the median number of attempts before achieving a final withdrawal     was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and     little studied. It seems that the type of interface used, mask or cannula, having an     influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by     non-invasive ventilation are not uncommon, regardless of the interface used . In a recent     randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and     non-invasive ventilation mode. It is in this case external damage. But we assume that the     breakdown causes internal lesions dependent on the pressure, humidity and flow. These factors     are likely to generate a nasal obstruction, source intervention nurses who aspire nasal     passages more or less traumatic.      The nasal cavities are often abused and, because of their key role in breathing, could be     involved in the withdrawal of ventilatory failure   "
35943|NCT02815332|"     This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled     study.      Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply     1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night     for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be     performed to assess efficacy.      Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the     level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical     examination, clinical laboratory tests, cutaneous tolerance score, incidence of     minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches     suggestive of pseudotumor cerebri, and collection of adverse events.   "
35944|NCT02815319|"     Docetaxel chemotherapy is commonly used in patients with breast cancer. With the widespread     use of steroid premedication, the incidence of fluid retention and skin toxicity side effects     has been minimal. Premedication with dexamethasone (8mg twice daily) is recommended starting     the day before chemotherapy and continuing for three days. Patients may forget to take all or     part of their premedication prior to docetaxel administration, and additional doses of     steroids are frequently give in place of the forgotten oral dose. The processes around     treating patients who have incorrectly taken their medication are cumbersome leading to     significant delays in patients receiving their chemotherapy while the chemotherapy nurse     tries to contact the patients treating physician for guidance on the dose and route of     dexamethasone they want administered. Most importantly with the current standard of care     procedure, by the time the chemotherapy nurse, pharmacist and medical oncologist have spoken     and made a treatment plan, the patient has been waiting for on average of an additional 1-2     hours before actually starting their chemotherapy.   "
35945|NCT02815306|"     Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in     children. The Ponseti method is an effective protocol for treatment of congenital idiopathic     clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace     that can be used for the treatment of clubfoot in newborns and infants instead of plaster.   "
35946|NCT02815293|"     The objectives of this study are twofold        -  To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared          to its vehicle in patients with evaporative dry eye (EDE)        -  To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in          patients with EDE   "
35947|NCT02815280|"     This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical     administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne     vulgaris.   "
35948|NCT02815267|"     This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical     administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne     vulgaris.   "
35949|NCT02815254|"     The focus of this project are elderly people who have experienced hip fracture and need at     least two weeks rehabilitation after discharge from hospital. The aim is to increase the     evidence-based knowledge base for planning and appropriate follow-up intervention for     patients with hip fracture on short-term / rehabilitation stays. In this study the     investigators want to explore whether training High Intensity Functional Exercises (HIFE) ,     of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a     significant positive effect on physical function, pain and quality of life. The main aim is     to explore whether a high intensive strength and balance training program has better effect     than a low intensive strength and balance training program on functional status measured by     Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to     explore whether this high intensive strength and balance training program has better effect     than a 'low intensive strength and balance training program' on pain, endurance and quality     of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36.     The study is a randomized controlled trial.   "
35968|NCT02814994|"     The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases.     In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of     death in patients. There is no unified treatment process for ARDS currently and the treatment     measures are not yet standardized, so the standardization of ARDS treatment processes is     needed to reduce mortality in patients. Following the evidence-based medicine principles and     six-step treatment standards of ARDS, this study uses the method of multi-center randomized     controlled clinical trials to evaluate the standardized treatment process of ARDS, which     provides the basis for the standardized treatment of ARDS.   "
35952|NCT02815215|"     Congenital clubfoot(CCF) is a kind of common congenital foot deformities in children. Though     Ponseti method can cure most of the CCF patients, there are still part of patients can not     get satisfactory recovery, especially those children classified as Dimeglio grade Ⅲ and Ⅳ.     Carroll's technique is considered to be an ideal method of surgical treatment. But the     postoperative scar is relatively large, and accordingly the postoperative complications is     still common. Based on the clinical practice of the investigator's group, a modification of     Carroll's technique, minimally invasive Carroll's technique, was applied. For the Dimeglio     grade Ⅲ and Ⅳ CCF, the postoperative excellent and good rate was over 90%. Therefore, the     investigator conducted a multicenter randomized controlled trial on treatment of congenital     idiopathic clubfoot with minimally invasive Carroll's technique.   "
35953|NCT02815202|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
35954|NCT02815189|"     Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits     treatment of teeth with necrotic pulp and apical periodontitis after a two-year control     period.      110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working     length was established with EAL and confirmed radiographically. M4 system with Flex-R files     were used to complete canal preparation. Level of discomfort were recorded and cases with     severe postoperative pain and/or swelling were classified as flare-ups.   "
35955|NCT02815176|"     Thrombotic biomarkers and angiographic characteristics were compared among the de novo     patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV)     and the control.   "
35956|NCT02815163|"     Degenerative arthritis is a common and serious chronic illness that impacts the quality of     life of older adults. Knowledge about the effects of empowerment education program in older     adults with total hip replacement surgery are limited. As far as the investigators know, this     is the first study done using empowerment education intervention to promote total hip     replacement patients' self-care. This partnership is achieved through active participation to     learn as well as sharing their knowledge and experiences with clinicians and patients.     Furthermore, patients had developed some degree of self-efficacy and improve their depressive     mood from the disease related knowledge acquired.   "
35957|NCT02815150|"     This study aims to assess the impact of preoperative oral carbohydrate drink on gastric     emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore,     investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate     in elective gastric cancer surgery, providing direct evidence for clinical practice.   "
35958|NCT02815137|"     The purpose of this study is to determine if the XPO1 E571K mutation could be used as     molecular residual disease biomarker in classical Hodgkin's lymphoma. To determine the     interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and     specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax     determined by Positron Emission Tomography after C2 and at end of treatment.   "
35960|NCT02815111|"     The purpose of this research study is to see if pain can be better controlled with fewer side     effects. The new drug regimen will study several different medicines that have different ways     of treating pain.   "
35961|NCT02815085|"     The primary objective is to examine feasibility of incorporating RecoverLINK into the     standard of care as a function of (i) user engagement, (ii) user satisfaction, and (iii)     workflow efficiency. As secondary objectives, the investigators will collect preliminary data     to examine the association between patient engagement with the RecoverLINK app and (i)     changes in patient knowledge and behavior, and (ii) hospital readmission(s) at 30, 60, and     90-day time periods post-enrollment.   "
35962|NCT02815072|"     Medical researchers of National Heart Centre Singapore will carry out a state-of-the-art     study that examines the possibility of changing patients' own cells into multi-functional and     potent stem cells called iPS cells. These iPS cells can subsequently give rise to functional     cardiac cells (myocytes) and other cardiovascular cells which might give further clues into     the manifestation of the structural heart disease. This study involves blood sample     collection for pre-screening and skin biopsies to establish skin cell culture.   "
35963|NCT02815059|"     This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and     multi-dose study evaluating the use of ibrutinib in combination with dasatinib and prednisone     therapy.   "
35964|NCT02815046|"     This study compares mixed urinary incontinence symptoms before and after a combined treatment     with Botox and Bulkamid. Eligible for the study are adult females with a mixed urinary     incontinence, having both urgency urinary symptoms and stress urinary symptoms.   "
35998|NCT02814604|"     There is a lot of confusion when it comes to understanding nutrition information on food     packages, thus making it difficult for consumers to choose healthy products. In today's busy     and fast-paced shopping environment, mobile digital technology (for example, Smartphone     applications) can help consumers make 'healthier' food choices when they are shopping. This     study will investigate whether a traffic light front-of-pack system or an overall star rating     system, coupled with an automated healthfulness comparison feature, on a Smartphone app can     help consumers identify and purchase healthier foods.   "
35965|NCT02815033|"     The aim of the study is to assess the clinical utility of 11C or 18F-Choline Positron     Emission Tomography (PET)/Computed Tomography (CT) scan, Whole Body Magnetic Resonance     Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements     in response prediction to treatment with Enzalutamide in Hormono-Sensitive Metastatic     Prostate Cancer patients.      The study will assess how these 2 imaging modalities perform compared to traditional serial     PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and     response to treatment with Enzalutamide.      In addition measurements of serially collected circulating tumour cell (CTC) samples,     cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in     terms of response measurement.   "
35966|NCT02815020|"     The purpose of this project is to use the Agency for Healthcare Research and Quality patient     self-management support tools and resources across four practice-based research networks and     16 member practices using a community-based participatory intervention called Boot Camp     Translation.   "
35967|NCT02815007|"     The purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI     for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer   "
35969|NCT02814981|"     On 04/30/2015, ANSM (the National Security Agency of Medicines and Health Products) shared an     information for general practicioners, pediatricians, anesthesiologists, dermatologists,     geriatricians, psychiatrists, community pharmacists and hospital about using hydroxyzine and     the associated risk of QT prolongation on the electrocardiogram.      Drugs containing hydroxyzine (the best known and most used is the Atarax®) are used in France     in various indications including the treatment of minor manifestations of anxiety,     premedication with general anesthesia and the symptomatic treatment of urticaria.      A prolonged QT interval is a known risk factor for occurrence of torsades de pointes which     can cause sudden death. We distinguish congenital and acquired long QT interval. The main     cause of acquired long QT interval is a drug inhibition of the HERG potassium channel 1. Many     drugs have been reported to cause sudden death by prolongation of QT interval and occurrence     of torsades de pointes (macrolides, anti -arythmics, some psychotropic ...) The molecules     based on hydroxyzine are known to be at risk of prolongation of QT interval in an     experimental point of view but is not clearly identified in daily clinical practice.     Pharmacology unit of Caen was the first to publish a case of QT prolongation under     hydroxyzine . Through this publication, associated with other clinical data, hydroxyzine has     been added to the list of drugs that can induce QT prolongation .      Despite these recent recommendations, it does not seem that hydroxyzine prescriptions were     changed daily and therefore the risk of QT prolongation persists. We therefore propose the     study of the impact of hydroxyzine on the QT interval measured on the electrocardiogram in     patients hospitalized at the University Hospital of Caen.   "
35970|NCT02814968|"     The aim of the study is to assess the clinical utility of 18F-fluoro-deoxyglucose Positron     Emission Tomography (PET)/Computed Tomography (CT) and Whole Body Magnetic Resonance Imaging     (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in     response prediction to treatment with Enzalutamide in castration-resistant prostate cancer     patients.      The study will assess how these 2 imaging modalities perform compared to traditional serial     PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and     response to treatment with Enzalutamide in castration-resistant prostate cancer patients.      In addition measurements of serially collected circulating tumour cell (CTC) samples,     cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in     terms of response measurement.   "
35971|NCT02814955|"     Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing     prevalence AF. The purpose of paroxysmal AF processing is to control outbreaks from these     pulmonary veins, medicated way (antiarrhythmic) or interventional. Ablation (radiofrequency     or cryotherapy) has become in this context recognized and effective treatment of AF. In     addition, antithrombotic treatments in this context is a major treatments for the prevention     of stroke (stroke). They are most often associated with antiarrhythmic treatment to prevent     recurrence of AF or to slow it during a relapse.      Recent experimental studies have highlighted the direct electrophysiological properties of     dabigatran and rivaroxaban in the pulmonary veins and the left atrium. Dabigatran     demonstrated in this study that it induced a prolongation of potential action in the     pulmonary veins and the left atrium and it decreased the incidence of FA-induced by     stimulation. Conversely, rivaroxaban induces shortening of the action potential in the left     atrium (untested properties in the pulmonary veins). To our knowledge, apixaban and warfarin     have not been studied in this context.      It is therefore possible that some of the new oral anticoagulants (NACOS) or some AVK     (fluindione and warfarin), have direct electrophysiological effects in the pulmonary veins     and on the left atrium and could influence AF recurrences (with effect  antiarrhythmic-like     or rather a pro-arrhythmic effect) after ablation.A retrospective analysis conducted at the     University Hospital of Caen on very low numbers suggest that patients on dabigatran would     have less pulmonary veins connected in early ablation procedure that patients on warfarin or     rivaroxaban. Despite the limitations inherent in this analysis (very low numbers,     retrospective analysis, unique setting and having studied his own limits), these results are     consistent with the fundamental studies, and thus encourage us to pursue our hypothesis to     obtain more statistical power and reliability in our measurements and results.      We therefore propose the study of the electrophysiological effects of NACOS (apixaban,     dabigatran, rivaroxaban) and warfarin (warfarin and fluindione) on the pulmonary veins and     the left atrium of patients referred for ablation of paroxysmal AF (radiofrequency or     cryotherapy ) the CHU of Caen and Tours and clinic Saint Martin Caen.   "
35972|NCT02814942|"     Aim:To determine the baseline characteristics of heart failure patients in Singapore     undergoing cardiac resynchronization therapy (CRT); the long term outcome and predictors of     response to CRT.      Methodology:Among patients undergoing CRT for severe heart failure according to indications     stipulated in international Cardiology guidelines, baseline demographic data is collected.     Age, gender, NYHA functional class, co-morbidities, QRS width on ECG, presence of left bundle     branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection     fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are     collected. In addition, during the CRT implant procedure, blood is drawn from the vascular     access and analysed for NT-pro BNP levels and other biomarkers of heart failure.      The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and     12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV     (left ventricular end-systolic volume index to body surface area) of >/= 15% and/or an     increase in the LVEF of >/= 10%.   "
35975|NCT02814903|"     Post-operative atrial fibrillation (POAF) is a major and frequent complication occurring     after cardiac surgery, contributing to prolonged intensive care and hospital stays and is     associated with several cardiovascular complications. The exact mechanisms and signaling     pathways involved in the development of POAF seem to be multifactorial and remain to date     incompletely understood. β-blockers and amiodarone are the first line preventive drugs but     are partially effective and near 30% of POAF resist to these strategies. In this context,     there is some evidence indicating that renin-angiotensin-aldosterone system and Galectin-3     (Gal-3) share signaling pathways in the development of cardiac fibrosis and therefore could     be very useful predictive biomarkers of POAF and potentially interesting therapeutic target     to prevent POAF occurrence.      The investigators hypothesis is that preoperative plasma aldosterone levels and galectin-3     (Gal-3) expression (in plasma, right atrial appendage or epicardial fat) could be predictive     of POAF in patients undergoing elective CABG surgery with preserved LVEF.   "
35976|NCT02814890|"     The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine     could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral     block is performed at the end of video-assisted pneumonectomy.   "
35977|NCT02814877|"     The main objective of the project is to evaluate the efficiency and cost-effectiveness of     different strategies aiming at optimizing antibiotic prescribing in hospitals. In the first     section of the project, the project team intend to map the different antimicrobial     stewardship programs in French hospital, by investigating a sample of 30 healthcare     facilities, and determine the strategies to be evaluated by the model. The investigators will     also evaluate physicians' adherence to the intervention to promote better use of antibiotics     and explore potential barriers and facilitators to the implementation of effective     strategies.   "
35978|NCT02814864|"     Patients receiving radiation therapy are still at risk for side effects due to off-target     radiation damage of normal tissues The number of cancer patients is expected to increase from     14.1 million around the world in 2012 to 19.3 million in 2025. Up to ten percent will develop     late severe gastrointestinal complications (i.e. Pelvic Radiation Disease - PRD). Symptoms     are proctopathy (5-20%) and radiation-induced cystitis (3,5%) that affect quality of life.     The treatment of PRD is limited to managing the symptoms; new alternatives should be     proposed.      Clinical trials using MSCs to treat hemorrhagic cystitis, proctopathy have demonstrated the     feasibility to used MSCs in these pathologies :        -  MSCs successfully repair hemorrhagic cystitis, and perforated colon in patients with          hemorrhagic cystitis, perforated colon and peritonitis.        -  Six clinical trials are currently ongoing for proctopathy, 3 are phase III. Results          suggest an inhibition of chronic inflammation and fistulization and interruption of          hemorrhagic syndromes.        -  Clinical trials to evaluate the efficacy of MSCs to treat hemorrhagic cystitis is in          progress.        -  A decrease in pain after the injection of MSCs was observed in patients treated by          radiotherapy for breast cancer, radiation burns, and radiotherapy over-dosage.        -  Four patients, were treated with MSCs after receiving overdose pelvic irradiation for          prostate cancer. A decrease in pain (EN score), bleeding and diarrhea was observed.      MSCs will represent a promising alternative strategy in the treatment of severe enteritis,     rectitis and cystitis after radiotherapy, and may avoid surgical treatment and may diminish     the adverse effect of PRD in terms of chronicity, morbidity, mortality and health costs.   "
35979|NCT02814851|"     The left atrium appendage (LAA) is a remnant of the original embryonic left atrium formed     during the third week of gestation. LAA is believed to function as a decompression chamber     during left ventricular systole and other periods when left atrial pressure is elevated. The     LAA is also a major endocrine organ and is the main producer of ANP (atrial natriuretic     peptide) in the human heart. The ANP concentration is 40 times higher in the LAA walls than     in the rest of the atrial wall. A study of patients having undergone the maze procedure and     associated LAA removal found a significantly lower ANP secretion and an increase in salt and     water retention. Whether this could eventually lead to hypertension or heart failure symptoms     is not known.      Removal of the LAA is routinely performed during antiarrhythmic surgical techniques (MAZE     surgery) to reduce the risk of subsequent LAA thrombus. Furthermore, new percutaneous     ablation techniques target LAA to reduce further risks of atrial fibrilation recurrences.     However, in addition to effects on diastolic atrial function and atrial natriuretic peptide     (ANP) secretion, this could potentially reduce stroke volume and cardiac output and may thus     promote heart failure. Its removal could be particularly detrimental in patients with     existing heart failure and high intraatrial pressure, as it would further promote pulmonary     congestion and also reduce their cardiac output.      The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac     surgery and cardiology wards. Subjects referred for non valvular cardiac surgery will be     prospectively included during the first 6 months following the onset of the protocol.     Echocardiographic and invasive data will be collected simultaneously.      The goals of the study are:        -  To evaluate the immediate impact of temporary closure of the LAA using a vascular clamp          in the beating heart of human subjects during cardiac surgery. Impact of LAA occlusion          will be measured using transesophageal echocardiography and hemodynamic measurement of          the cardiac output.        -  To correlate echocardiographic parameters with in situ hemodynamic data.      A significant role of the LAA in the cardiac hemodynamic including the left ventricle outflow     might have different clinical implications and will raise questions about:        -  Appropriateness of LAA resection in antiarrhythmic surgery        -  Importance of restoring sinus rhythm in atrial fibrilation patients        -  Importance to spare LAA from ablation during atrial fibrilation ablation to avoid          significant consequences on cardiac function.        -  Appropriateness of the LAA occluding device in atrial fibrillation patients.   "
35980|NCT02814838|"     The objective of this clinical trial is to investigate whether ladarixin has sufficient     activity (preservation of β-cell function and slow-down of the progression of T1D) to warrant     its further development (proof of concept trial). The safety of ladarixin in the specific     clinical setting will be also evaluated.      The study will be a phase 2, multicentre, double-blind study. It will involve 72 patients     with new-onset type 1 diabetes (T1D), randomly (2:1) assigned to receive either ladarixin     treatment (400 mg b.i.d. for 3 cycles of 14 days on/14 days off - treatment group) or placebo     (control group). Recruitment will be competitive among the study sites, until the planned     number of patients is enrolled.   "
35981|NCT02814825|"     The purpose of this post-market study is to collect data on ViviGen and how its use affects     fusion rates in the cervical spine when used as additional grafting material to fill the     cervical spacer. The patient population of interest is patients who have already elected to     undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.   "
35999|NCT02814591|"     In this study spatially offset Raman spectroscopy (SORS), which allows the collection of     Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The     principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.   "
36000|NCT02814578|"     The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is     non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by     OCT at 1-year follow-up.   "
35982|NCT02814812|"     Pancreatectomy represents the classic approach for resectable lesions of the pancreas,     duodenum and periampullary region. Due to the technical skills required, the complex anatomy     and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still     considered to be at risk of postoperative complication mainly due to pancreatic juice leaks.     Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the     activation of pancreatic enzymes and the following infectious and hemorrhagic complications.     Severe complications negatively affect postoperative outcomes, long-term survival, quality of     life, and costs. Operative mortality traditionally has been defined as the rate within 30     days or during the initial hospitalization. But in pancreatic surgery mortality rates within     90 days after pancreatic resection are double those at 30 days. In the present study, the     investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh     postoperative day before discharging the patients to detect undiagnosed postoperative     complication.   "
35983|NCT02814799|"     The research for a haemostasis and for an effective osseous healing are a major stake in oral     surgery. The use of glues of fibrin, amplifying the polymerization of the fibrin during the     haemostasis is known to reduce the risk of post-operative bruise and accelerate the healing     but these glues present the inconvenience to be by-products of the blood, not devoid of     infectious risk.   "
36003|NCT02814539|"     The purpose of the study is to determine whether the neurodevelopmental outcome and in     particular executive functions in 9 to 11 year old school children with congenital heart     disease who underwent cardiopulmonary bypass surgery during their first three months of life     is impaired in comparison to healthy children at same age. Executive functions are higher     order cognitive functions and critical for school success.   "
36956|NCT02801968|"     The purpose of this study is to determine the efficacy of Tap block after cesarean delivery     as a component of multimodal analgesia and evaluation of postoperative drugs consumption.   "
35984|NCT02814786|"     This research will lead to the first evaluation of intrinsic and dynamic joint and muscle     mechanics of equinus in cerebral palsy. It would provide a direct cause and effect     relationship between equinus and bone deformity. Mechanical insights to the pathophysiology     of the targeted muscles will lead to better understanding and, thus, to a better medical and     surgical management of equinus deformity. Secondary aim will provide an important insight     whether key gait parameters can be exclusively relied upon for surgical treatment planning     and evaluation. In a medium-term perspective, depending upon the results of this study,     dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case     of cerebral palsy.   "
35985|NCT02814773|"     With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and     related syndromes are a major public health issue. The lake of drug for treatment or     preventing AD, health related quality of life (HRQoL) became an essential criterion of     evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally     less sensitive for a given disease. That is why other specific tools for AD have been     developed. None of them was validated in French. The aim of this study was therefore, after a     review of the literature, to achieve a cross-cultural adaptation and psychometric validation     of the Quality of Life in Alzheimer's Disease (QoL-AD) and Dementia Quality of Life     (DQoL). These two questionnaires were selected because they were the most popular in English-     language literature for this disease.This study concerned a total of 155 patient-caregiver     pairs recruited from six French hospitals and a Francophone Swiss center. Patients had a     confirmed diagnosis of AD (mild stage to moderate: Mini Mental State Examination ≥ 10).     QoL-AD and DQoL were administered by an interviewer. The caregiver sheet of QoL-AD was     self-administered. Cross-cultural adaptation and psychometric validation have been carried     out for these two questionnaires.   "
35986|NCT02814760|"     Acute stroke management represents a true medical emergency that requires prompt diagnosis     and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region,     France (AVC69) (Porthault et al. 2013) the investigators observed that only a small     percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients     treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of     patients reached hospital through an emergency department instead of going directly to a     stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of     patients arrived in the emergency department too late to be thrombolysed. However, among the     subset of ischemic stroke patients who reach emergency department less than 3 hours after     symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis,     only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED     professional's knowledge and skills and to develop together efficient clinical pathway would     decrease door-to imaging time and consequently door-to needle time and eventually improve     overall thrombolysis rate.      The investigators have conducted a cluster randomized controlled stepped wedge trial. All     adult patients with suspected stroke arriving in one of the participating ED were included in     the study along five successive four-month periods. The program featured: development of     written materials (booklets) and video (film), and one day session of standardized training     for trainers, at least one nurse and one physician of all EDs, with formal presentation to     improve knowledge, and simulation to improve skills for using the FAST tool (nurses) and     the NIHSS score (ED physicians). Additionally, a clinical pathway was developed to adapt     general evidence based guidelines to the local organization. The primary outcome is the     door-to imaging time.   "
35987|NCT02814747|"     After the use of DNA chips for diagnostic purposes, high-throughput sequencing (HTS) is     transforming the field of developmental diseases, from fundamental research to care.     Nonetheless, before HTS can be transferred to everyday clinical practice, in particular for     expert diagnosis using exome HTS, it is necessary to anticipate the nature of the information     to be given to patients and to parents in order to obtain consent for exome HTS.      The objective in terms of public health is to allow patients with rare diseases to benefit     from innovative technologies in optimal conditions of information and accompaniment.      the objectives of this project are to        1. evaluate the preferences of families of patients with development disorders as regard to          suspicious and incidental findings from HTS before its introduction for diagnostic          purpose,        2. and then, following the exome analyses carried out for diagnostic purposes, describe,          analyse and understand the experience, expectations and reactions of families and          geneticists concerning the diagnostic trajectory in general and at the time the results          of the HTS were announced in particular A methodology that associated quantitative and          qualitative approaches was chosen so as to combine the advantages and overcome the          shortcomings of each: a quantitative study to investigate a large number of patients,          which would ensure a certain representativeness of the population and allow sub-groups          analyses to study the upstream phase concerning indications for high-throughput          sequencing; and a qualitative study, which though it allows only a small number of          patients to be investigated, makes it possible to describe, analyze and understand in          depth the complex downstream phenomena of high-throughput sequencing results   "
36001|NCT02814565|"     The purpose of this study is to assess the effect of cyclobenzaprine hydrochloride (HCl)     extended release (CER) 15 mg once daily in subjects with muscle spasms associated with acute     painful musculoskeletal conditions.   "
41296|NCT02745080|"     The purpose of this study is to compare the safety and efficacy of secukinumab monotherapy     and adalimumab monotherapy in patients with active psoriatic arthritis who are naïve to     biologic therapy and are intolerant or having inadequate response to conventional DMARDs   "
35988|NCT02814734|"     Abdominal Compartment Syndrome (ACS) is a well known condition occuring in critically ill     patients in intensive care units.      This syndrome features a sustained intra abdominal hypertension (IAH) above 20 mmHg and a     multiple organ failure due to the raise of the intra abdominal pressure.      Several reviews described CT findings linked to these conditions, but most of them suffer an     insufficient statistical method.      Furthermore, the main CT feature described as specific in ACS, Round Belly Sign (RBS), has     been highly debated since.      This study is aimed to evaluate, in a prospective way, the diagnostic and prognostic value of     CT findings in abdominal hypertension and abdominal compartment syndrome patients hosted in     intensive care units, based on previous reviews and adding three new CT features described     for the first time.   "
35989|NCT02814721|"     Infiltrations from cannulation difficulties result in significant morbidity including loss of     vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and     VA characteristics. Surface marking of VA lacks real-time information and traditional     ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic     Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD)     approved for VA cannulation. Study is a single center randomized, prospective pilot study     comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard     cannulation practices.   "
35990|NCT02814708|"     Toxic Shock Syndrome (TSS) is a severe condition with high morbidity and mortality from the     hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible     for almost all of menstruation associated and more than 50% of all other cases. There is no     specific therapy.      The aim of this study is to extend the safety and tolerability of two doses of the BioMed     recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine after one to three     vaccinations in healthy adults. The second aim of the study is to measure immunogenicity and     persistence of antibodies which produced in response to treatment with the BioMed rTSST-1     Variant Vaccine over a period of 12 months. These antibodies are expected to be important in     prevention and mitigation of the diseases. 140 healthy adults, male and female, age 18-64     years will be assigned to 7 groups comprising two doses of the vaccine or adjuvant at the     Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be     monitored for vital signs, hematology, clinical chemistry, and antibodies against TSST-1.     Immunization will be repeated 3 months after the first with the same dose and 6 months after     the second immunization in the respective groups.      Antibodies will be determined through monitoring TSST-1 binding antibodies as assessed     through ELISA and neutralizing antibodies (exploratory endpoint) as assessed by inhibition of     T cell activation (3H Thymidine incorporation; ≥ 50%).   "
35991|NCT02814695|"     The purpose of this study is to evaluate the efficacy of Baker's yeast extractions ,     probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm     motility,progressive motility and vitality as well as comparing this potency to that of     Vitamin E in infertile men.   "
35992|NCT02814682|"     The purpose of this study is to elaborate a multi-dimensional indicator of the quality in     palliative care for patients of end-of-life.      The study will, as secondary objectives:        -  elaborate in a standard manner one set of indicators of organization and inner working          of a palliative care setting.        -  compare according to these indicators, the qualities of 3 types of palliative care:          palliative care unit in hospitals, specified identified bed for palliative care patients          and non-specified bed.        -  explore the relationship between organizational aspects and results in term of burden.   "
35993|NCT02814669|"     This study is designed to assess the safety and tolerability of atezolizumab when given in     combination with radium-223 dichloride in participants with metastatic CRPC who have     progressed after treatment with an androgen pathway inhibitor. An adaptive design is planned     to first investigate the tolerability with concurrent administration (both treatments to     begin in Cycle 1). However, if the combination is not tolerated, additional cohorts may be     enrolled to evaluate the tolerability of radium-223 dichloride (to begin in Cycle 1) with     delayed atezolizumab (to begin in Cycle 2 and/or 3).   "
35994|NCT02814656|"     AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which     presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and     potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The     therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism     bronchodilators, with an equivalent or superior safety and tolerability profile. The primary     purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A     multiple ascending dose (MAD) design has been selected for this study following the first     time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an     ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses     will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the     previous dose. The aim of this study is to also enable further investigations in healthy     subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable     side-effect profile compared to other inhaled bronchodilators on the market as a treatment     for COPD and asthma.   "
35995|NCT02814643|"     This is a randomized, double-blind, parallel group, placebo-controlled study designed to     investigate the potential effect of a fixed dose of benralizumab administered subcutaneously     (SC) on antibody responses following seasonal influenza virus vaccination   "
35996|NCT02814630|"     This is a single center, non-comparative exploratory study, to investigate the effect of     omalizumab over a 3-month treatment period in adult (≥18 years) patients with chronic     idiopathic urticaria who had remained symptomatic despite the use of high dose     H1-antihistamines.   "
35997|NCT02814617|"     The investigators performed randomized, double-blind, placebo-controlled human trial to     evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces     hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity     parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ,     TNF-α).   "
36013|NCT02814409|"     The principle research question is: in patients with acute ischaemic stroke eligible for     intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on     functional outcome as assessed by modified Rankin Scale distribution at day 90?   "
36002|NCT02814552|"     Hypertension (HTN) is a major risk factor for coronary heart disease (CHD), heart failure,     kidney failure and stroke. Disparities in HTN prevalence, treatment and control in the US     have persisted for decades. The prevalence of HTN is 44% among Blacks, which is among the     highest rates in the world. Those in ethnic/racial, rural, socioeconomically disadvantaged     and other medically underserved populations are known to have the worst blood pressure (BP)     control. Awareness of, treatment for, and control of HTN is not optimal, and varies according     to race, whereby BP is controlled in ~53% of non-Latino Whites, 42% of non-Latino Blacks and     only 34% of Latinos. Fundamental underlying differences in the pathophysiology contribute to     HTN among different race groups. The United States (US) 2014 HTN recommendations outline     race-based pharmacotherapy care for HTN. However, these recommendations use race-based     population assumptions for Whites and Blacks only, do not include Latino ethnicity and have     no accompanying guidelines or tools for successful implementation, particularly in rural     primary care practices where disparate populations are common. Moreover, these     recommendations only apply to initial therapy and lack guidance on subsequent regimen     selection. The Optimizing Precision of HTN Care to Maximize BP Control Pilot (OPTI-BP Pilot),     will directly address a long known and growing health disparity concern in the US which     includes higher rates of death from CHD and stroke among Blacks and the poorest rates of HTN     control among Latinos. Utilizing a mixed methods approach, the overarching goal of OPTI-BP     Pilot is to test, using a pragmatic trial design, a personalized, algorithmic-based HTN     management approach focused on age, race, biomarker (plasma renin activity) and treatment     factors. The investigators hypothesize that implementation of a precision-based approach to     the care of HTN in the community will improve BP reduction and ultimately reduce risk for     CHD, stroke and death among those most affected by HTN.OPTI-BP Pilot is significant because     it will utilize an innovative, systematic, precision-focused HTN management approach in an     underserved, diverse population where BP control is currently suboptimal and lays the     infrastructure groundwork for broad implementation across all areas of the US to minimize HTN     related disparities and improve HTN outcomes.   "
36004|NCT02814526|"     This study evaluates the effects of physical exercise on cognition, functional status, brain     atrophy and blood flow, and cerebrospinal fluid biomarkers of Alzheimer's disease in adults     with a mild memory impairment.      Half of participants will participate in a stretching-balance-range of motion exercise     program, while the other half will participate in a moderate/high aerobic training program.   "
36005|NCT02814513|"     In this feasibility study, the researchers would like to investigate whether it is feasible     to apply the ANDAGO V2.0, a new mobile robot for body-weight supported gait training     (developed by Hocoma AG) to children and adolescents undergoing neurorehabilitation. The     investigators will explore several outcomes and will compare some outcomes between the     children and adolescents when they walk in the ANDAGO or with their regular walking aids.   "
36006|NCT02814500|"     An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the     pharmacokinetics characteristics of DP-R212   "
36007|NCT02814487|"     Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for multiple     sclerosis (MS) patient clinical evaluation. However, its practical implementation is not     always optimal as it can prove to be very time consuming. Moreover, it often constrains the     range of tests used and is not a particularly good marker for patient real life disability     status.      A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was     developed in order to replicate each of MSFC tests available in order to assess MS     progression in the patient environment.   "
36008|NCT02814474|"     Starvation and metabolic stress increase circulating ketone bodies, potentially providing the     heart with an alternative oxidative fuel. Hyperketonemia reduces myocardial fatty acid     consumption. It is unclear whether this is due to inhibited peripheral lipolysis or     diminished uptake per se.      Aim: To test whether infusion of 3-hydroxybutyrate (BHB) inhibits myocardial glucose and     fatty acid uptake.      Methods: Randomized, single blinded, cross-over interventional study in 8 healthy volunteers.     Myocardial glucose and fatty acid metabolism studied by 11C-palmitate and 18F-FDG PET/CT.     Experimental elevation of circulating ketone bodies by infusion of     β-hydroxy-β-methylbutyrate.   "
36009|NCT02814461|"     To determine the maximal tolerated dose (MTD) of axitinib in combination with RT for advanced     HCC.   "
36010|NCT02814448|"     The purpose of this study is to test two innovative devices, the CryoPen® and     thermocoagulator, against gas-based cryotherapy to determine whether the novel devices     produce equivalent or improved destruction of cervical tissue compared to gas-based     cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the     CryoPen and gas-based cryotherapy will also be compared.   "
36011|NCT02814435|"     Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision     cases in the UK and starts at an early age. The purpose of this observational study is to use     the results of two questionnaires and a computerised test testing contrast sensitivity, to     assess the impact of IRD on quality of life. This study will involve collecting data from     patients with IRD, but also collecting data from normal controls.   "
36012|NCT02814422|"     Because of the rapid aging of the global population, dementia has become a serious problem,     and Alzheimer's disease (AD) is the most common cause of dementia. AD is pathologically     characterized by substantial neuronal loss and chronic inflammation that is associated with     cerebrovascular and parenchymal accumulation of proteinaceous deposits enriched in     amyloid-beta (Aβ). More recent evidence shows it is due to an increased blood-to-brain     delivery of circulating Aβ, and significant peripheral Aβ metabolism occurs in association     with post-prandial triglyceride-rich lipoproteins.      In the prodromal stage of AD, patients usually suffer mild cognition impairment (MCI). The     annual conversion rate of MCI to AD is around 10%, and within 3 years, around 30%−50% of     these develop dementia. Brain atrophy is an irreversible brain disease that causes problems     with cognitive and memory functions in many diseases, such as MCI and AD, etc. In order to     allow preventive intervention for AD, MCI must be diagnosed as early as possible, using     biomarker assays or simple imaging modality. From 2009-2013, the investigators have     registered 4,492 patients with atherosclerotic vascular diseases (AVD). In addition, the     investigators have also registered 8,209 cases with no evidence of AVD, but with at least 1     cardiovascular risk factor. In this 5-year project, 300 male or female patients with stable     symptomatic AVD over 20 years of age, and the other 600 patients with no evidence of AVD but     with at least 1 CV risk factor, will be enrolled from our previous registry program. The     baseline and yearly follow-up study will include clinical examination, neurocognitive     function evaluation, and laboratory tests (TC, HDL-C, LDL-C, TG, hs-CRP, and Aβ-40, Aβ-42,     tau protein, and other biological signatures: adiponectin, MMP-3, MMP-9, IL-6, Fibrinogen,     Lp-PLA2, 8-Isoprostane, hFABP, sVCAM-1, sICAM-1, CA-125, MCP-1, TNF-α, cTnI, NT-proBNP, CNP,     NGAL).      The purposes of this 5-year project are (1) to clarify the association of triglyceride-rich     lipoprotein and the development of dementia; (2) to validate the diagnostic power and     prognostic implication of ultra-low-concentration biomarkers (Aβ−40, Aβ−42 and tau) for     dementia.   "
41297|NCT02745067|"     The primary objective of this study is to gain knowledge about the effectiveness of enhanced     cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN).   "
36014|NCT02814396|"     Cardiovascular disease (CVD) is the leading cause of death worldwide. Most individuals with     CVD show no evidence of disease for decades as the disease progresses before the first onset     of symptoms, often a sudden heart attack, finally arises. The spatial repolarization     heterogeneity within the ventricular myocardium had been proposed to represent the function     of the heart in health and disease. Greater than normal levels of repolarization dispersion     may allow early diagnosis of CVD. There is a growing interest in the characteristic features     of ventricular repolarization that leads to lethal ventricular arrhythmia even with the use     of non-antiarrhythmic drugs. The recovery time dispersion may reflect a repolarization     heterogeneity leading to lethal ventricular arrhythmia. Previously, the investigators had     utilized a 64-channel low-TC SQUID MCG device to develop and verify 2 parameters, so called     smooth index of QTc (SIQTc) and T wave propagation (TWP), to accurately detect and localize     the myocardial ischemia. Recently Nakai, et al. reported that a newly developed 187-ch     signal-averaged vector-projected ECG (187-ch SAVP-ECG) could evaluate low-amplitude     high-frequency potentials and repolarization heterogeneity. In this project, the     investigators'll try to modify and improve the spatial resolution of ECG signals from a     Self-built-in multichannel ECG system with a newly developed algorithm, and also try to     derive the SIQTc and TWP from this system, for early detection of CVD. The investigators     intend to prove the concept that this newly developed multichannel ECG system could     efficiently detect or diagnose CVD with acceptable sensitivity and specificity, and in a     portable way.   "
36761|NCT02804503|"     Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and     how menu labels affect calories and macronutrients ordered in Hispanics is not clearly     understood. This study evaluated the impact of menu labels on calories and macronutrients     ordered in Hispanics.   "
36015|NCT02814383|"     Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at     high risk for developing brain injury in the first week of life. Intraventricular hemorrhage     (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of     infants. Their incidence is inversely proportional to gestational age (GA) and birth weight     (BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance,     visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic     hemodynamics during transition from intra- to extra-uterine life and during the early     neonatal period is believed to be at their genesis. While the incidence of ultrasound-     diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected     by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive     care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity     and brain volume and eventual neurocognitive impairment.      Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to     irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has     remained relatively stable. Once translated to the bedside, the goal of this research is to     develop a monitoring system that will allow researchers to identify infants most at risk for     IVH and PVL and in the future, intervention studies will be initiated to use the changes in     cerebral perfusion to direct hemodynamic management.      The purpose of this study is to first understand the physiology of brain injury and then to     eventually impact the outcomes in this high-risk group of infants by assessing the ability of     the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to     predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for     this study will help develop algorithms or monitoring plans that will maintain the     appropriate brain perfusion pressure and thereby, prevent severe brain injury.   "
36016|NCT02814357|"     Double-blind, randomized, controlled, cross-over design with 3 test products and one control     product.      To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour     15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG)     and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made     from 100 gram of flour compositions.   "
36017|NCT02814344|"     The original aspect of the methodology proposed for this study concerns the use of as many as     16 electrodes to study the propagation and coordination (or synchronization) of uterine     contraction. Over the last two years, the Compiègne University of Technology and the     University of Reykjavik (Iceland) teams have developed the tools required to obtain good     quality signals during electrohysterography and have worked on filtering and mapping of     uterine electrical activity derived from these signals.   "
36018|NCT02814331|"     This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS     electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of     epileptogenic foci in order to perform multimodal mapping and localization of interictal     spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG     electrode implantation strategy prior to surgery in children with drug-refractory partial     epilepsy.   "
36019|NCT02814318|"     The aim of this project is to identify the duration of vancomycin administration at which     group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal     mucosa. This will aid in labor management and delivery planning to ensure that the mother     receives adequate GBS prophylaxis while also minimizing the duration of exposure to     vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic     workup of neonates whose mothers received vancomycin intrapartum.      This study aims to identify the time after administration of IV vancomycin at which GBS     colonies are 100% eradicated.   "
36020|NCT02814305|"     Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases     to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse     prescription opioids obtain these pills from friends or family members who have surplus     medication left over from prior prescriptions. There is little published data on surplus     opioid analgesics remaining after patients recover from painful procedures. Even less is     known about patients' willingness to dispose of these leftover pills.      Aims: 1) Measure the impact of a risk education intervention and a financial incentive     intervention on patients' willingness to dispose of surplus opioids left over after     outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused     after outpatient dental surgery.      Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn     Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients     will be randomized to a control group, an educational intervention, or a financial incentive     intervention. The primary outcome of the trial is the proportion of patients in each arm that     express willingness to return their unused opioids. Secondary outcomes include patient use of     prescribed opioids and their number of unused pills. These outcomes will be measured using     novel text-message based data collection software that patients will interact with using a     web-enabled cellular telephone or tablet.   "
36021|NCT02814292|"     Validation of the PEFS to detect breast tumors will be performed by means of a prospective     trial. Subjects will participate for 1 clinic visit. Readings from the PEFS will be studied     for reproducibility and predictive ability. Data analysis will be iterative, moving on with     each modification of the device until the final prototype is created.   "
36023|NCT02814266|"     OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic     measurements alone or in combination in predicting difficult intubation. The investigators     hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are     sensitive and specific tests for predicting difficult intubation MATERIALS AND METHODS: The     investigators included the data of 170 patients (85 difficult intubation and 85 easy     intubation) who underwent an abdominal surgery under general anesthesia. Patients in     difficult intubation (n=85) and easy intubation (n=85) groups were matched by age, BMI, and     gender. Intubation difficulty scale (IDS) scores were recorded. Upward and downward maximal     protrusions of tongue (UMPT and DMPT, respectively) were evaluated in all patients.     Anthropometric measurements were measured.   "
36047|NCT02813954|"     Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF pH     can be affected by both maternal and fetal conditions such as preterm ruptures of membranes,     prematurity and fetal distress. While fetal urine is the major content of AF since 20th     gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion of FLL     depends on chloride transport and postnatal clearance of FLL is provided by active     reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an     increase of pulmonary compliance accompany to pulmonary adaptation developing at the first     hours of life. Lower genomic expression of Na channels in airways is shown to be associated     to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF is     thought to be relevant to fetal and maternal conditions such as gestational age, antenatal     steroids and preterm birth, there is no study about this topic in the literature.   "
36024|NCT02814253|"     This study is being done to collect information that will be used in the development of a new     medical device. The new device is intended to help people with COPD to monitor their     condition at home on a daily basis.      The device used in this study is called a capnometer. Different types of capnometer have been     in use by doctors for many years. Capnometers measure the amount of carbon dioxide in your     breath. The device that is used in this study is called the N Tidal C. It is a small,     battery-powered personal device for you to use indoors either at home, at work or in     hospital.      The study fits around the normal treatment, tests and medication of COPD patients and there     will not be any changes made to the treatment of any study participants.      The study lasts for six weeks. Standard care clinical assessments will be taken at the start     of the study, after 2 weeks, 4 weeks and 6 weeks. The tests for COPD include a check-up by     the study doctor or nurse including the usual spirometry and blood gas tests. Each assessment     visit will last for between 15-20 minutes.      At the start of the study each participant will be trained in the use of the device and they     will be asked to use the device to record their normal relaxed breathing, 3 times a day     (morning, afternoon and evening) every day for the 6- week period. A reading takes     seventy-five seconds of ordinary breathing through the device.      Participants who feel unwell, or have an infection, will be asked to take more frequent     breath records of up to six times a day if possible. This would be twice in the morning,     twice in the afternoon and twice in the evening, leaving at least an hour between readings.      Participants will also be asked to complete a simple daily diary of how their health and COPD     changes and information on the use of the device.      Participants will receive a telephone call 2 weeks after their last assessment visit to check     how they are and to ask if any of their medicines have changed.      Participants will not benefit directly from taking part in this study and the device used in     the study does not provide any feedback to them. The information we get from this study will     help us to develop the device, and to learn more about the treatment and management of COPD.   "
36025|NCT02814240|"     The investigator put forward the hypothesis that liver fat mass in patients with pituitary     gland failure is greater than that in a control population. Failure of the anterior pituitary     and more particularly impaired production of growth hormone (GH) could be the principal     mechanism responsible for increased liver fat mass in these patients.   "
36026|NCT02814227|"     Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an     estimated 18-40 million adults and 0.7-3% of all children in the US. The marketplace     currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA     screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA     screening tool would allow greater screening of at-risk individuals, especially in     underserved communities with low socioeconomic status, hopefully encouraging a greater     proportion of such individuals to seek treatment for their condition. The specific goal of     this project is to compare the Zansors® micro sleep sensor screening device against     gold-standard polysomnography to establish the device's preliminary validity to screen for     OSA accurately.   "
36027|NCT02814214|"     The purpose of this study is to collect simultaneous surface electrocardiogram (ECG)     recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM)     recordings of variations in electrical synchrony.   "
36028|NCT02814201|"     Action slowing has been demonstrated in many diseases. Parkinson's disease (PD) and     Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia,     particularly the medial globus pallidus, and the clinical expression of these two diseases is     characterized by a combination of motor and cognitive disorders, but with two opposing     patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and     has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive     origin. Far fewer studies have been conducted in Huntington's disease. However, all of these     studies were performed with different methodologies in small cohorts and the value of the     proposed study is to use a validated and standardized computerized mental chronometry     paradigm, providing a better understanding of the mechanisms of action slowing in these two     diseases and to more clearly define a disease-specific profile.   "
36029|NCT02814188|"     Carbohydrate ingestion, in particular fructose, has been shown in a handful of previous     studies to elicit a thermic effect and increase core body temperature after ingestion.     Carbohydrate foods and supplements are commonly consumed prior to endurance running     competition, including situations where an athlete's ability to dissipate body heat is     compromised. Thus, there is some potential for pre-exercise carbohydrate ingestion to have a     deleterious effect on body heat regulation in hot and humid environments. Thus, this projects     aims to study the effects of pre-exercise carbohydrate ingestion on core body temperature,     perceived thermal stress, and perceived exertion during high-intensity running.   "
36030|NCT02814175|"     An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country     study in subjects with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 is designed to     compare the achievement of minimal disease activity (MDA) between subjects randomized to     either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the     highest recommended or tolerable dose; Part 2 is to evaluate the maintenance or achievement     of MDA on four different treatment regimens using adalimumab and/or MTX, with subject     allocation based on the initial randomized treatment and achievement of MDA in Part 1, and     with rescue treatment option.   "
36031|NCT02814162|"     The purpose of this study is to evaluate the predictive value of serum adiponectin levels in     aneurysmal subarachnoid hemorrhage patients.   "
36032|NCT02814149|"     The aim of this prospective cohort study is to compare the esthetic, clinical and     patient-centered outcomes following immediate and delayed implant placement protocols.   "
36033|NCT02814136|"     Ablation of atrial fibrillation is an established method for treatment of subjects with     atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide     area circular ablation (WACA) is shown to provide the same results with fewer complications.     This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects     who are considered for ablation of atrial fibrillation.   "
36056|NCT02813837|"     This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric     antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell     derived leukemia and lymphoma that is relapsed (after stem cell transplantation or     chemotherapy) or refractory to chemotherapy.   "
36078|NCT02813551|"     Currently there is no intervention to prevent persistent postpartum hypertension in     preeclamptic women. Physiologically, the use of a pharmacokinetically predictable     loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated     secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the     incidence of persistent postpartum hypertension in preeclamptic women.   "
36079|NCT02813538|"     The aim of this study is to evaluate early clotting disorders through thromboelastogram and     anticoagulant proteins levels (maybe also endothelial markers) and liver function by     indocyanine green clearance after major liver resection and search for a potential     relationship between them.   "
36034|NCT02814123|"     The closed-loop delivery system is composed of an insulin pump, a continuous glucose sensor     and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings.     Pramlintide is a drug and an analog of amylin, a hormone that is co-secreted with insulin in     healthy individuals, and is deficient in people with type 1 diabetes. Co-injection of     pramlintide with insulin at meal times improves glucose control in type 1 diabetes.     Literature data suggests that regular insulin may better match the effect of pramlintide     compared to rapid insulin in regulating post-prandial glucose levels.      The purpose of this study is to compare the effectiveness of 3 strategies to control your     day-and-night glucose levels:        1. rapid insulin-alone closed-loop delivery;        2. rapid insulin-plus-pramlintide closed-loop delivery;        3. regular insulin-plus-pramlintide closed-loop delivery.      The primary hypotheses are:        1. During closed-loop control, the simultaneous basal-bolus infusion of pramlintide and          fast-acting insulin improves glucose control compared to fast-acting insulin-alone          infusion.        2. During closed-loop control, the simultaneous basal-bolus infusion of pramlintide and          regular insulin improves glucose control compared to fast-acting insulin-alone infusion.   "
36035|NCT02814110|"     Importance: Currently the gold standard treatment for ambulant patients is corticosteroids.     Granulocyte colony-stimulating factor (G-CSF) has been reported to exert the proliferation of     satellite cells, the regulation of myoblast proliferation, and the differentiation and     promotion of muscle regeneration and repair.      Objectives To evaluate the safety and efficacy of G-CSF in children and adolescents with     muscular dystrophies Duchenne muscular dystrophy, Becker muscular dystrophy ,     Fascioscapulohumeral dystrophy.      Design, Setting, and Participants: Patients aged 5-15 with diagnosed muscular dystrophies     will be included in an open study. Patients wheelchair-bound and and mobile and     self-independent can participate in the study. Patients also treated with steroids can     participate in this study. Clinical examination and physiotherapeutic and laboratory tests     will be perform. G-CSF (5mcg/kg/body/d) is given subcutaneously for five consecutive days     during the 1st, 2nd, 3rd. 6th and 12th months. Manual muscle testing (Lovett test) of the     upper and lower extremities, isometric force with the hand dynamometer, and the 6MWT (six     minute walk test) are measured before and after therapy.   "
36036|NCT02814097|"     This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with     stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4     weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.   "
36037|NCT02814084|"     The question this research project wants to explore is whether using the Prevena Incision     Management System (Prevena) will improve sternal wound edge oxygenation in patients     undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts.   "
36038|NCT02814071|"     Acute pancreatitis (AP) in children has an increasing incidence and is at times associated     with significant morbidity and mortality. Despite this, there is no high-quality     evidence-based treatment for childhood AP and current practice is based entirely on     historical approach and extrapolation from adult studies.      In this study, we evaluate the use of early enteral feeding in children with AP. The     traditional approach to treating AP relies on fasting and intravenous fluids (or occasionally     parenteral nutrition) assuming that this minimizes stimulation of an already inflamed     pancreas. Contrary to this, evidence exists that early feeding of patients with AP may be     beneficial. Randomized controlled trials of fasting vs. early oral diet in adult patients     with mild AP, showed no differences in pain, serum amylase and CRP levels, but also shorter     hospital stay in those fed earlier. Further data in adults with severe AP demonstrated that     early enteral nutrition was associated with decreased mortality, infections and multiorgan     failure. These benefits were lost if enteral nutrition was commenced 48 hour after admission.     Suggested explanations for these findings include the possibility that enteral nutrition may     maintain integrity and function of intestinal mucosa and reduce gut-origin sepsis.      Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in     the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require     moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data     suggest that oral feeding with a low fat diet was as safe as NJ feeding.      Several animal models of AP demonstrate that the exocrine pancreas is resistant to     cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack     of concern of exacerbating pancreatitis with enteral feeds.      Considering this data it is less certain that diet and fat restriction contribute to     treatment of AP. To further challenge the prior conceptions of AP management it is necessary     to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a     population with recognized low complication risk.      Despite the mounting evidence to the contrary, it is still standard clinical practice to fast     children with AP, and only slowly reintroduce feeds depending on the clinical improvement.     This is largely due to the lack of clinical interventional studies in children with AP.   "
36039|NCT02814058|"     The purpose of this study is to evaluate the pharmacokinetics of the new formulation of     zolpidem hemitartarate orodispersible tablet 1.75 mg in male and female healthy volunteers.   "
36040|NCT02814045|"     Alzheimer's Disease (AD) is the most prevalent neurodegenerative disease, manifested as an     initial deficit of episodic memory that evolves into a global cognitive and psychosocial     dysfunction and which prevalence is increasing around the world. Sleep disturbance is     frequent since early stages of the disease and sleep fragmentation had been demonstrated     increase the production of amyloid peptide (AB) (main pathological hallmark) in non-demented     population. Obstructive Sleep Apnea (OSA), which consist in intermittent hypoxia and sleep     fragmentation, is a major health problem with multiple systemic effects and it's very     prevalent in AD. However, the influence of this comorbidity on the cognitive evolution of AD     patients remains unknown. The investigation of neurobiological markers and sleep recording     may reveal potential mechanisms of neurodegeneration and explain the influence of sleep     fragmentation and/or hypoxia on cognitive decline.      To fill those gaps, investigators will perform a multidisciplinary and translational project     to assess the progression of symptoms in AD patients, diagnosis of sleep disturbance and new     biomarkers of progression of the disease.      The present proposal is going to be developed by coordination of different expertises that     will be range from the clinical research conducted by a medical neurologist, to the animal     model and most molecular work, to be done by an experimented group in mouse work.   "
36041|NCT02814032|"     Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become     the malignant neoplasm of fastest growing incidence rate. More than 85% thyroid carcinoma is     papillary thyroid carcinoma. Cervical lymph node metastasis is common in papillary thyroid     carcinoma patients. This study aim to reveal protein expression differences between papillary     thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node     metastasis.   "
36042|NCT02814019|"     The purpose of the study is to assess the efficacy of idebenone in delaying the loss of     respiratory function in patients with DMD receiving concomitant glucocorticoid steroids   "
36043|NCT02814006|"     This study will asses the effectiveness of two strategies for timed intercourse in couples     actively trying to conceive   "
36048|NCT02813941|"     Background: Summary of Findings (SoF) tables have been developed to present results of     systematic reviews in a concise and explicit format. Adopted by many review groups including     the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ), and the     GRADE Working Group; SoF tables provide succinct, transparent, and easily interpretable     judgments about the certainty of evidence and magnitude of effects. Currently, there are     three different SoF formats in use. This study aims to compare SoF table formats in terms of     understanding, accessibility, satisfaction, and preference with systematic review users.      Methods: The primary objective of this three-arm randomized controlled non-inferiority trial     is to investigate whether an alternative GRADE-SoF table, or EPC-SoF table, is noninferior to     the current GRADE-SoF table in the understanding of information presented to systematic     review users. Researchers, clinical practice guideline developers, policy-makers, end-users,     or knowledge transfer will be recruited. Data will be collected electronically at baseline     and after randomization. Noninferiority would be declared if the difference in the proportion     of participants who understand the information displayed in the alternative SoF table is 10%     or less.      Discussion: This study aims to assess the understanding, accessibility, satisfaction, and     preference between three SoF tables for displaying summary evidence from health-related     outcomes. The results of this study will provide important knowledge to understand what     information should be included in SoF tables in systematic reviews.   "
36049|NCT02813928|"     Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor     relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses     is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect     recurrences or metastases, a surveillance strategy is recommended for patients able to     withstand complementary treatment during a five-year period. Over this period, the     probability of one false-positive result is 87%. Considering that less than 10% of recurrent     patients are suitable for potentially curative treatment and that more intensive programs     enable an increase of the overall rate of curative resection but do not result in reduced     mortality, less time and cost-consuming, tailored follow-up is necessary. The level of     circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex®     method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and     surveillance.      Tubes for ccfDNA analysis will be taken during medical examination at the same time of the     CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for     analysis in the laboratory INSERM (National Health Institute) of Montpellier and the     remaining plasma will be kept in biological collection.      Patients will have a consultation of follow-up every 3-4 months during which the dosage of     CEA and ccfDNA will be realized as well as a medical examination, a general examination     (weight, size, and blood pressure), an evaluation of the indices of performance status and a     nutritional evaluation in case of loss of weight.   "
36050|NCT02813915|"     The investigators would like to study cardiac output, stroke volume, and fluid responsiveness     on young adult pediatric patients undergoing anesthesia and surgery with the use of the     NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable     trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with     routine monitoring will provide a better assessment of intra-operative status.   "
36051|NCT02813902|"     This proposal describes a pilot study to gather preliminary evidence of efficacy,     tolerability and toxicity of oral PLE among a high-risk skin cancer population for the     prevention of Actinic keratosis (AKs) and keratinocytes (KCs) to gain insight into optimal     methods for recruitment, intervention development, data collection, and promoting protocol     adherence prior to conducting a fully powered trial. The primary clinical outcome is AKs as     measured by a clinical dermatologist, with skin cancer as a secondary clinical outcome. The     investigators will also assess histologic markers of Ultra Violet (UV) damage, which have     previously been shown to be reduced with oral PLE use in human studies, namely formation of     UV-induced cyclo pyrimidine dimer positive cells and number of sunburn cells among epidermal     keratinocytes. Results generated from this proposal will form the foundation of a fully     powered clinical trial of the effect of PLE on the risk of AKs and KCs. The results may also     provide information about this promising dietary supplement which may provide extra     protection for a high-risk skin cancer population.   "
36052|NCT02813889|"     The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung     and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each     toy will be equipped with sensors capable of measuring the infant's grasping actions such as     squeezing, pinching, tilting, etc.      A low-cost 3D motion capture system will be used to collect video data and the infants'     reaching and body kinematics in response to the toys. A pressure mat will be used to measure     postural changes to detect weight shifts, rolling, crawling and other movements away from the     initial posture. By capitalizing on these wireless and low-cost technologies, it will permit     the regular and non-invasive monitoring of infants, which can lead to detailed,     non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators     also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical     developing infants. The investigators will include infants' ages 3 to 11 months who are     categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.   "
36053|NCT02813876|"     Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol     compared to standard care for recovery of patients with acute pancreatitis.   "
36080|NCT02813525|"     Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function     and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has     previously been described in a population of normal fetuses. Fetuses with IUGR, the     velocities recorded in the aortic isthmus could be affected and the normal development of the     ISI should be changed, because of the increase in placental resistance on one hand, and the     gradual deterioration ventricular functions on the other one. Investigators hypothesize that     the ISI index in the context of placental insufficiency could provide additional arguments on     the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The     primary outcome of the study is to evaluate in an exploratory manner the feasibility and the     potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic     isthmus and the calculation of the ISI index.   "
36057|NCT02813824|"     The proposed trial will evaluate the effect of aspirin 300 mg/d and 100 mg/d during 4 years     vs placebo, in a 4 groups randomised parallel design in Lynch syndrome patients: patients     with proven carriers of pathological mutations in mismatch repairs genes and patients with     personal and family history characterizing Lynch syndrome according to modified Amsterdam     criteria without proven mutation, aged more than 18 years with signed informed consent. The     main hypothesis to be tested is that aspirin could decrease colorectal adenoma recurrence     evaluated during high quality follow-up by colonic chromo-endoscopy in Lynch syndrome     patients. The trial will also explore: (i) colorectal neoplasia recurrence according to     different germline alteration in mismatch repair genes, (ii) observance to chemoprevention in     Lynch syndrome patients, (iii) the burden of adverse events attributable to aspirin in Lynch     syndrome patients, (iv) the dose-effect of aspirin on adenomatous polyp burden. All     pathological samples will be reviewed using a centralized procedure. The INCA regional     network organization and the HNPCC patient organization will allow the recruitment and the     follow-up of a large number of patients with well characterised Lynch syndrome.   "
36058|NCT02813811|"     Temperature-controlled Laminar Airflow (TLA) treatment delivered by the Airsonett treatment     device is a new treatment for patients with allergic asthma.      The LASER Trial (temperature-controlled Laminar Airflow in Severe asthma for Exacerbation     Reduction - LASER) is a trial, currently evaluating whether the Airsonett device is able to     reduce the frequency of asthma attacks in patients with allergic asthma.     (www.lasertrial.co.uk)      Participants who successfully complete at least 6 months of follow-up in the LASER trial are     eligible for the post trial provision of 4 years of an active TLA treatment device.      To date there is no long term performance data available to show whether there is any     sustained benefit from the long term use of the Airsonett device, whether any improvement in     asthma control or quality of life is maintained and whether patients will continue to use the     treatment device beyond 12 months (the length of the longest previous trials of TLA     treatment.)      The investigators plan to assess the performance of the Airsonett device by recording the     frequency of asthma attacks in patients over a 4-year period (48 months.) The investigators     also wish to evaluate the effect of long term TLA treatment on asthma control, quality of     life, healthcare resource use and patient acceptability of longer term use of the Airsonett     device.      Participants will be sent and asked to complete a series of questionnaires on a 6 monthly     basis over the 48 month study period. Questionnaires will be returned by post to a single     study centre based in Portsmouth, UK. Participants will also be contacted by telephone on a 6     monthly basis by a member of the trial team to collect information about their medication,     healthcare resource use and whether they have had any asthma attacks since their last     contact.      Participants will not be expected to visit the study centre during the trial.   "
36060|NCT02813785|"     This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate     the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab     compared with docetaxel in participants with locally advanced or metastatic NSCLC who have     progressed during or following a platinum-containing regimen. Treatment may continue until     disease progression, loss of clinical benefit, or unacceptable toxicity.   "
36061|NCT02813772|"     Infant colic (IC) is responsible of 25% of pediatric consultation in the first 3-4 months of     life affecting from 5% to 30% of infants between 2 weeks and 3 months of life (3, 4). The     variability in the prevalence of IC reported by the several studies depends on different     criteria used to define IC.The etiology of IC remains still unclear. Recently, the     composition of intestinal microbiome has been addressed as an independent risk factor for IC.     There are no uniform criteria for a specific therapeutic approach of IC. Based on these     conclusions the objectives of our study are: to determine whether the administration of a     partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is     beneficial in IC in reducing the infant crying duration and in prolonging the duration of     sleeping period   "
36062|NCT02813759|"     To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC)     available on the glycemic response, postprandial C peptide and satiety in patients with type     2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).   "
36063|NCT02813746|"     The aim of this study is to understand the epigenetic and transcriptomic mechanisms that     regulate the fetal origin of adult diseases (FOAD), either for the presence of metabolic     disorders in the future mothers, such as obesity or for the exposure to certain contaminants     such as tobacco.      To do that, the miRNAs profiles secreted to the endometrial fluid in obese women vs     normoweight women during the window of implantation will be identified. Likewise, it will be     studied how that miRNA signature is normalized once a substantial loss of weight is produced     by the patients involved in the studied. In parallel, a comparison of the miRNA expression     profiles secreted in the endometrial fluid in smoker women vs nonsmoker women will be     performed. As in the previous case, it will be studied if after the exposure to these     contaminant, the normalization of the miRNA expression signature occurs. Finally, an in     silico analysis will be carried out in order to define the target genes and the metabolic     pathways affected by the miRNAs profile secreted in both pathological conditions   "
36064|NCT02813733|"     In a large prospective cross-sectional study, the investigators aimed to identify the     determinants of thyroid surgery outcomes and quantify the relative influence of preoperative     and intraoperative factors. For this purpose, the investigators considered the interplay of     several characteristics specific to surgeons, patients, and surgical procedures.   "
36065|NCT02813720|"     Nearly 30% of patients with cutaneous psoriasis (PsO) developed psoriatic arthritis (PsA).     Among these patients 20 % will have severe destructive arthritis. The risk of developing PsA     is significantly higher in patients with nail involvement (OR = 2.24; 95% CI [1.26-3.98]).     The risk is particularly high for the peripheral form of PsA and onycholysis (OR=2.80; 95% CI     [1.34-5.85]).      Thus the investigators wanted to test the hypothesis that onycholysis, in patients without     PsA, is a potential clinical marker of subclinical distal enthesopathy and, by extension, of     bone micro-structural alterations.      Patients and Methods      The investigators will recruit 4 groups of subjects:        1. Patients with peripheral PsA,        2. Patients with psoriatic nail onycholysis,        3. Patients with PsO only        4. Healthy match control subjects. The investigators will assess the presence of          enthesopathy by ultrasonography and bone structural damages (by HR-pQCT) in all subjects          at baseline and 4 years.   "
36127|NCT02812914|"     Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral     strategies to the millions of households worldwide that continue to burn solid cooking fuels     using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and     pneumonia, are associated with high exposures to household air pollution during pregnancy and     early infancy. The proposed study will assess the feasibility and acceptability of an     introduced liquid petroleum gas stove, complemented by two alternative approaches to     delivering tailored behavioral change interventions, among pregnant women and their neonates.   "
36066|NCT02813707|"     The World Health Organization (WHO) statistics, in 2008, there were more than 1.4 billion     adults, aged 20 and older, and were overweight. Of these over 200 million men and nearly 300     million women are obese. Body Mass Index (BMI) more than 30 is considered as obese and     increasingly bariatric surgery is the commonest way used nowadays to lose weight. Moreover,     surgery will influence many other health factors and parameters. Many studies prove the     improvement of metabolic and psychological status of patients post bariatric surgery. In     addition, many vitamins will be affected and should be replaced. This research study is     continuation (PART 2) of previously approved study (approval: 13/54). Brief findings of the     study are attached. Our aim in this part of the study to assess long term the impact of     bariatric surgery on metabolic, nutritional and quality of life status on patients post     bariatric procedure of at least 12 months post-surgery follow up. As we noted in our previous     initial study that there is significant loss the collection of the data due to no show for     proper follow up routine care. Previously it was approved to consent patients by phone calls     and extract information regarding Quality of Life (QoL) post-surgery. This will be replaced     by seeing the patients in the outpatient clinic and providing the necessary information and     consent.   "
36067|NCT02813694|"     This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment     of adults with moderate community-acquired bacterial pneumonia   "
36068|NCT02813681|"     Historically, women who have chronic back pain after pregnancy have attributed the cause to     the epidural procedure. While many studies have shown no greater incidence of generalized     post-partum back pain in those who received an epidural, no studies have measured localized     pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might     limit patient's mobility and activities in the post-partum period. Understanding the factors     that increase insertion site pressure sensitivity will allow the investigators to modify     epidural placement technique in order to minimize this effect.   "
36069|NCT02813668|"     This study will test the implementation, effectiveness, cost-effectiveness, and acceptability     of a worksite lifestyle improvement program that includes lifestyle education classes led by     trained individuals from the worksite and improvements in the worksite environment that will     make it easier for employees at risk for diabetes or with unmedicated diabetes to lose     weight, exercise more, and eat a healthier diet. A total of 2000 participants across 8     worksites in India (4 from Delhi and national capital region [NCR] region and 4 from Chennai)     will be involved in this study for 5 years.   "
36070|NCT02813655|"     The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in     the treatment of post-dural puncture syndrome in patients receiving epidural analgesia,     spinal analgesia, or combined spinal-epidural analgesia for labour.   "
36071|NCT02813642|"     To evaluate the relationships between bone mineral markers levels at dialysis start and     vascular calcification progression during a 2 year follow up   "
36072|NCT02813629|"     So far, no study investigated the safety and efficacy analgesic of transcranial direct     current stimulation (tDCS) associated to peripheral electrical stimulation (PES) in     individuals with SCD who suffer from chronic pain. Several studies have reported a decrease     in O²Hb concentration in the regions below the electrodes and in other cortical areas during     anodic or cathodic tDCS, which implies a risk factor for vasoocclusive events in individuals     with SDC due to polymerization of hemoglobin when exposed to these low O²Hb concentrations.     For this reasion, the aim main of this study is to assess the effect of a single session of     transcranial direct current stimulation (tDCS) associated to peripheral electrical     stimulation (PES) on safety and efficacy analgesic in individuals with sickle cell disease     (SCD). Others aims sencondaries are evaluate the effect of a single session of transcranial     direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) on     biomarkers neurophysiological and inflammatory.   "
36073|NCT02813616|"     Chronic constipation (CC) and Irritable Bowel Syndrome with Constipation (IBS-C) are two     conditions difficult to manage because factors affecting dissatisfaction to treatments are     misleading. This observational multicentric national study is aimed to assess which factors     are related with a clinically significant improvement in patients with CC and IBS-C. Patients     will be evaluated at baseline and after every one-month standard of care therapy with     standardised questionnaires to assess bowel habit and satisfaction to treatments.     Somatisation, quality of life, colonic transit time and resting anal pressure will be     assessed at baseline.   "
36074|NCT02813603|"     Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA     concerning the diagnostic yield, the quality and quantity of each biopsy needle without     raising the rate of complications.   "
36075|NCT02813590|"     Ascitic fluid microbiome is going to be investigated in this study by using internal     transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and     sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of     spontaneous bacterial peritonitis (SBP).      All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis     are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps     from puncture side and stool samples as well as conventional culture methods are performed to     investigate the difference in the microbiome between patients with and without SBP.   "
36076|NCT02813577|"     The post approval study will enroll US female patients presenting with claudication or     ischemic rest pain and an angiographically significant lesion in the superficial femoral or     popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix     Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2)     years.   "
36097|NCT02813304|"     The primary objective of this study is to compare the short-term effectiveness (2 and 6 weeks     following the start of the rehabilitation program), in terms of symptoms and functional     limitations, of a rehabilitation program centered on gradual reloading to a rehabilitation     program centered on rest and cryotherapy in individuals with acute rotator cuff tendinopathy.     The secondary objective is to explore the effects of these programs on shoulder control     (acromiohumeral distance), subacromial structures (supraspinatus tendon thickness) and     central pain modulation. The hypothesis is that the rehabilitation program centered on     gradual reloading will lead to a faster improvement at week 2 and 6 when compared to the     program centered on rest and cryotherapy.   "
36081|NCT02813512|"     The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue     Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant     autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects     who have chronic non-hemorrhagic stroke (>6 months).   "
36082|NCT02813499|"     Acute coronary syndrome (ACS) is a major health problem and its diagnosis remains a challenge     for the emergency physician. The management of a suspected ACS is well codified, based on     troponin assays, renewed if necessary.      Conversely, the criteria leading to initiate a diagnostic procedure in chest pain to the     Emergency department are unclear. The fear is, firstly, to miss a potentially life treating     diagnosis and, secondly, exposing many patients to unnecessary examinations. The advent of     highly sensitive troponin assays also increases the risk of over-investigation by a larger     number of elevations of the biomarker in non-coronary circumstances leading to a prolongation     of hospitalization and, possibly, unnecessary treatments and invasive investigations.      CARE rule could help to streamline this first step. It is established by assigning a value     from 0 to 2 to the items: Characteristic of pain, Age, Risk factors and ECG. The search for     an ACS is not justified if the sum of points is ≤1 (negative rule) and, conversely, a     troponin should be performed if the sum is > 1 (positive rule).      Indeed, CARE rule corresponds to the first 4 items of the HEART score (the latter standing     for troponin at admission) whose reliability has been demonstrated, a ≤3 income excluding ACS     with a risk of false negatives <2%. A negative CARE rule always corresponds to a HEART score     ≤3.      Our study aims to confirm the interest of CARE rule to streamline the search for an ACS in     chest pain as an observational European multicenter prospective study.   "
36083|NCT02813486|"     The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a     single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of     age.   "
36084|NCT02813473|"     The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates     the use of CT scan and angiogram of the heart to help doctors decide which method is the best     to improve blood supply to the heart in patients with complex coronary artery disease. Each     patient will undergo an angiogram and CT scan per standard of care. The randomization     strategy in this study is not between patients but between two teams of doctors, the     so-called Heart Teams, will be randomized: in the first round, team 1 assesses the     angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment     would be the best to treat complex coronary artery disease. In the second round, both teams     see the imaging method that they did not see in the first round, and make the decision again.     The final decision on the clinical treatment strategy is at the sole discretion of the Heart     Team and there are no criteria described in SYNTAXIII Revolution protocol leading influencing     this final decision.      Hypothesis: Determination of the best treatment strategy for coronary artery disease based on     a CT scan will result in similar decisions as based on invasive coronary angiography.   "
36085|NCT02813460|"     The purpose of this study is to evaluate in a double-blinded fashion the taste and overall     acceptability profile of different ALS-008176 oral liquid formulations as compared to the     reference formulation (ALS-008176: 60 milligram per milliliters (mg/mL) oral suspension     without sweetener/flavor) for pediatric clinical development and commercialization.   "
36086|NCT02813447|"     Objective: Determine whether treatment of perceived stress, anxiety, and depression with     anti-depressant therapy improves dyspnea scores, 6-minute walk (6MW) distance and quality of     life (QoL) in patients with Chronic Obstructive Pulmonary Disease (COPD) undergoing pulmonary     rehab.      The study is a prospective, randomized, double-blinded, placebo-controlled study to assess     the effect of an SSRI on 6MW, dyspnea scores, and QoL in COPD patients undergoing pulmonary     rehab. Thirty subjects that carry an ICD-9 code diagnosis of COPD and have mild to moderate     major depression according to the DIS and HRDS criteria will be recruited from Duke Pulmonary     Rehab.      Multivariable regression models will be constructed to evaluate the relationship between     perceived stress, anxiety, and depression with adjustments by race, gender, age, BMI and GOLD     score. A multivariable regression model will be constructed to assess whether treatment of     perceived stress, depression, and anxiety with antidepressant therapy (sertraline) is an     effect modifier on 6MW distance and dyspnea scores in patients with COPD who are enrolled in     pulmonary rehab.      Descriptive statistics will be used to examine the socio-demographic characteristic data.     Student t-tests will be performed to assess group differences in continuous data. Categorical     variables will be examined using the Pearson's Chi-Squared test.   "
36087|NCT02813434|"     This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45)     for the etiological diagnosis of poststroke cognitive impairment and dementia. This study     stems from two converging objectives: (1) the need to refine characteristics of vascular     cognitive impairment (VCI) and dementia (VD) in order to propose diagnosis criteria of VCI     and of mixed dementia and to improve diagnosis criteria of VD and (2) the need to improve the     etiological diagnosis of poststroke cognitive impairment and dementia. It will take advantage     from the ongoing GRECOG-VASC study (which determines the cognitive status 6 months poststroke     in consecutive patients according to a standardized international battery) coordinated by the     Amiens University Hospital center, the opportunity to perform amyloid imaging in vivo using     Positron Emission Tomography (PET) and Florbetapir (a production site is located in the city     of Amiens) and the collaboration between neurology and imaging departments of Amiens     University hospital.   "
36088|NCT02813421|"     The purpose of the study is to learn more about blood glucose control when people with Type 1     Diabetes switch to an insulin pump. The investigators hope to learn whether using a     continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to     stable blood glucoses and less frequent insulin pump dose changes during the transition to an     insulin pump.   "
36089|NCT02813408|"     The purpose of this observational study of metastatic castration-resistant prostate cancer     (mCRPC) participants is to explore whether or not there are differences between participants     treated with abiraterone acetate and enzalutamide on the health-related quality of life     (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).   "
37009|NCT02801279|"     The purpose of the present study is to develop a long term cost-effectiveness (efficient     protocol, playful context, and practical strategy) training program for school-age children     with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training     program for children with Cerebral Palsy.   "
36090|NCT02813395|"     Objective: Investigating the immediate effects of Low Level Laser Therapy (LLLT) on     neuromuscular performance in healthy subjects after an induced muscle fatigue protocol.     Methods: Eighty volunteers of both genders aged between 18 and 28 years underwent a     preliminary evaluation using surface electromyography and isokinetic dynamometer of the     flexor muscles of the elbow. The subjects were randomly allocated into 4 groups: G1 was     control group; G2 placebo; G3 laser applied before fatigue protocol; and G4 immediately     after. Muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions     at 120°/s of the elbow flexor muscles. An 808 nm equipment was used for applying laser     therapy, with a power of 100 mW and total energy of 20 J. Volunteers were reassessed after     interventions.   "
36091|NCT02813382|"     Considering fast-track principles, an ideal spinal anesthetic should have minimal     complications and above all fast recovery so reducing in-hospital stay.      Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with     an umbilical or unilateral inguinal hernia and no contra-indications for surgery were     included in this study. Patients were given 10.5mg bupivacaine (B-group), 40mg hyperbaric     2-chloroprocaïne (C-group) or 60mg prilocaïne (P-group), each with added sufentanil (2µg).     Motor block was assessed using the Bromage scale. Sensory block was measured by determining     the peak level dermatome. Intraoperative hemodynamic parameters were listed. Resolution of     sensory and motor block, time to void and home readiness were defined as clinical endpoints.   "
36092|NCT02813369|"     This post-authorization observational safety study (PASS) monitors clinically important     identified and potential risks within a cohort of patients treated with naloxegol, including     the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular     (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal     pain, diarrhea, syncope, and change in pain severity. This study is part of a broader     post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in     clinical practice.   "
36093|NCT02813356|"     The overall research goal for this study is to provide additional data to characterize the     safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer     and who are treated with opioids chronically.   "
36094|NCT02813343|"     This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its     implementation in 3 hospital/health system sites across Ontario. The 6 month study includes     300 participants that are randomized to an immediate treatment group or a delayed     intervention group. The primary outcomes include changes in HbA1c and patient reported     outcomes and experience measures. Qualitative interviews with various stakeholders will     explore issues relating to successful implementation.   "
36095|NCT02813330|"     To compare the effect of subcutenous sterile water injection technique with the subcutaneous     saline injection technique in the degree and duration of low back pain-relieving during     childbirth   "
36096|NCT02813317|"     This prospective, multicenter, observational study aims to explore a comprehensive approach     to the care of early breast cancer patients in a regional health territory (including 1.5     million women and characterized by a breast cancer incidence and mortality higher than     national ranges), incorporating all healthcare actors inside and outside the hospital.   "
36125|NCT02812940|"     A phase II clinical study to assess the efficacy of short-term everolimus as prophylaxis for     Graft-versus-Host disease (GvHD) in addition to post-transplantation cyclophosphamide after     allogeneic hematopoietic stem cell transplantation in patients with haematological     malignancies   "
36098|NCT02813291|"     The mental repetition of movements - or motor imagery (MI) practice - facilitates motor     learning. It allows avoiding fatigue that occurs during physical practice; this method is     thus particularly interesting for elderly people. Transcranial direct current stimulation     (tDCS) is a noninvasive method of neurostimulation during which a low direct current is     applied to the brain via electrodes placed on the scalp. This method has been successfully     used to enhance motor learning in both young and elderly subjects.      The main aim of this study is to assess the impact of MI practice combined with tDCS on the     learning of a complex finger sequence, in young and elderly subjects.      For that purpose, young and elderly healthy subjects will be randomly assigned to Stimulation     and Sham groups. There will thus be a total of four groups: Young Stim, Young Sham, Elderly     Stim, and Elderly Sham.      All subjects will participate to three training sessions spread over five days, and a     retention test one week after the third training session.      During training they will mentally repeat a complex finger sequence with the left hand, for     13 min:        -  Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in          parallel an anodal tDCS of the primary motor cortex.        -  Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a          sham tDCS of the primary motor cortex.      Immediately before (pretest) and after (posttest) each training session, as well as during     the retention test, subjects will repeat the sequence as many times of possible, for 1 min.     During these tests (pretests, posttests and retention test) electroencephalographic activity     will be recorded to assess the Mu rhythm power.   "
36099|NCT02813278|"     Colorectal cancer resection is one of the most common types of abdominal surgery. Though most     patients undergoing colorectal resection show recovery of bowel movements within a week, some     have prolonged intestinal paralysis or postoperative ileus, resulting in decreasing patient     comfort, increasing morbidity and mortality, a longer hospital stay and subsequent increased     healthcare costs.   "
36100|NCT02813265|"     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented     clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2     drops instilled in each eye four times daily (QID).   "
36101|NCT02813252|"     This study will provide long-term follow-up for patients who have received treatment with     JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15     years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of     persisting JCAR015 vector sequences, and survival.   "
36102|NCT02813239|"     In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present     a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro     oocyte maturation is still an experimental technique, with poorer results than conventional     IVF. For that reason improve in in vivo maturation could have a better impact on reproductive     outcome.   "
36103|NCT02813226|"     In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC)     planned to have hormonal treatment, will undergo conventional imaging and functional imaging     prior to treatment and post treatment to determine if changes in imaging results will be     prognostic of outcome. Patients will have a clinical follow-up every 3 months post     randomization for one year and followed for survival at Years 2 and 3.   "
36104|NCT02813213|"     This is a double-blind randomized controlled clinical trial, that compares the percentage of     epithelialization of skin defects using the conventional meshed split thickness skin grafts     vs skin micro grafts.      Two techniques will be applied in the same patient. The skin defect will be divided in two     parts, and with a randomized method each half of this defect will be assigned to one of the     two techniques.   "
36105|NCT02813200|"     Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the     world and further increase in its prevalence and mortality has been predicted. Currently, the     main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the     anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:        -  long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),        -  long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).      These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®,     Handihaler® and Diskus®.   "
36106|NCT02813187|"     This is an observational, longitudinal real world registry of venous leg ulcers created from     electronic health record data obtained in the course of clinical care. Data from certified     electronic health records transmit data as part of the requirement to share data with a     specialty registry under Objective 10 of Meaningful Use of an EHR.   "
36107|NCT02813174|"     The primary aim of this study is to assess the relationship between personality style,     self-compassion and depression during pregnancy, to identify psychological risk factors,     particularly personality styles, that may contribute to the onset of PPD. Additionally, the     study will provide support for the effectiveness of Internet-based Compassionate-Mind     Training (iCMT) as a prevention intervention for Postpartum Depression (PPD) for women in the     2nd and 3rd trimester of pregnancy. The study will also assess differences along personality     predictors and depression severity as they relate to intervention outcomes (i.e. depression     in postpartum and self-compassion) and engagement. The researchers hypothesize that women     both at high and low risk for PPD will receive benefits from the intervention, however, those     who endorse more maladaptive personality traits will likely engage and benefit less than     those who do not endorse these traits.   "
36108|NCT02813161|"     This is an observational, longitudinal real world registry of diabetic foot ulcers created     from electronic health record data obtained in the course of clinical care. Data from     certified electronic health records transmit data as part of the requirement to share data     with a specialty registry under Objective 10 of Meaningful Use of an EHR.   "
36109|NCT02813148|"     This post-authorization observational safety study determines the characteristics of patients     prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in     follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.   "
36126|NCT02812927|"     This study compared two methods of insulin infusion by syringe pumps to assess the impact of     medical devices on the glycaemic variability in patients under IIT in ICU. The main objective     of the study was to show the superiority of the infusion system which permitted to dedicate a     line for the insulin administration on the standard installation in terms of control of     glycaemic variability.   "
36110|NCT02813135|"     The first molecular profiling protocols have been launched in Europe (MOSCATO-01 (Geoerger     2014), MAPPYACTS, INFORM, iTHER, SM-PAEDS, etc.) determining multiple actionable alterations     in pediatric recurrent cancers. Increasingly, stratified approaches are being implemented to     enrich clinical trials of molecularly targeted agents and possibly improve outcomes in     specific populations i.e. a molecularly enriched/predictive biomarker-driven approach. The     diversity and heterogeneity of the detected molecular alterations and the low number of     pediatric patients mandate an adapted, innovative trial design for the attributed treatment     options in order to satisfy the current unmet medical need.      This basket trial is designed to cover the targeting of several survival pathways in     oncogenesis that are currently not adequately employed for pediatric patients in Europe.   "
36111|NCT02813122|"     examination of the importance of the use of X-ray in bariatric surgery outcome.   "
36112|NCT02813109|"     The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr)     levels in infants are unreliable as a detector of renal function in the first few days of     life because they may continue to reflect maternal levels. Although few candidates appear to     be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm     infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine     the reliable urinary biomarkers to detect kidney injuries in preterm infants.   "
36113|NCT02813096|"     This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to     prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor     thrombus following curative resection   "
36114|NCT02813083|"     This study will help the investigators design a method to detect the disease-causing immune     cells in patients with rheumatoid arthritis (RA). Such methods are not currently available,     but if successful, would help scientists to better understand the causes of RA.   "
36115|NCT02813070|"     This was a Phase 2, multicenter study to assess the extent and patterns of [18F] flutemetamol     uptake in the brains of 3 groups of Japanese subjects: healthy volunteers (HV), amnestic mild     cognitive impairment (aMCI), and probable Alzheimer's disease (pAD), and to assess the     reproducibility of brain uptake and of image interpretation. Subjects underwent open-label     intravenous (i.v.) administration of Flutemetamol F 18 Injection and Positron emission     tomography (PET) imaging of the brain. Blinded visual image reads were performed by 10     independent board-certified readers (5 Japanese and 5 non-Japanese) with nuclear medicine     image interpretation experience. The blinded visual assessments were compared with the     subject's clinical diagnoses, and the agreement between the image interpretations made by the     2 groups of readers (Japanese and non-Japanese) was determined.   "
36116|NCT02813057|"     Comparison of physical activity parameters of the lower extremity muscles in patients who     received total extraperitoneal repair (TEP) and STOPPA repair.   "
36117|NCT02813044|"     A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus     inhalational anesthesia on perioperative period during transsphenoidal surgery. However, they     have limitations especially for the phase of recovery after anesthesia: a fragmentary     assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed to     assess the degree of recovery, specially after anesthesia and surgery. In this study, the     investigators aim to compare the quality of recovery after inhalational anesthesia and after     TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for     pituitary tumor under general anesthesia.   "
36118|NCT02813031|"     Nutritional clinical trial to evaluate the effectiveness of different functional meat     products on the nutritional status of healthy people   "
36119|NCT02813018|"     Management of postoperative pain is critical in the pediatric patients, however, safe and     effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia     is based on preventing a prolonged change in central nervous system function by blocking     afferent input before the surgical stimulation may evoke central sensitization and aggravate     amplification and prolongation of postoperative pain. However, the clinical efficacy of     preemptive analgesia is still controversial. In this study, the investigators aim to assess     the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for     corrective osteotomy of the lower extremities expecting severe postoperative pain.   "
36120|NCT02813005|"     Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during     general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.      The investigators hypothesis that procedure is shorter and more accurate in High Frequency     Jet Ventilation group reducing target movement induced by ventilation.   "
36121|NCT02812992|"     The hypothesis of the proposed study is that individualized assessment directed treatment     algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine     therapy. The project uses a CGA, which includes various tests and scoring systems, to     stratify patients as GO-GO, SLOW-GO or FRAIL patients. Depending on test results     patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group:     gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of     chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign     patients to their definite treatment arm. The primary objective is that CGA-stratified     patients do not decline in their CGA performance in response to chemotherapy measured as a     loss of five points or less in the Barthel`s ADL (ADL1 vs. ADL2 during core CGA assessment).   "
36122|NCT02812979|"     The principal objective is to show noninferiority of nebulized salbutamol through the high     flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction     compared to nebulization by the usual method (spray mask).   "
36123|NCT02812966|"     Investigators hypothesize in patients presenting with significant peripheral arterial disease     with clinical indications for treatment with angioplasty, there will be a difference in 12     month patency between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and     IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter.   "
36124|NCT02812953|"     A sample of plasma and whole blood will be obtained at 3 time points (pre-procedural, early     post-procedural and at hospital discharge). Test for platelet reactivity (LTA, light     transmittance aggregometry and Elisa PRI, Platelet reactivity index) and for multimeric VWF     (von Willebrand factor) analyses will be performed at the time of blood sampling. Aliquots of     plasma will be stored and frozen for further analyses   "
36129|NCT02812888|"     Clustering of various metabolic parameters including abdominal obesity, hyperglycaemia, low     high-density lipoprotein cholesterol, elevated triglycerides and hypertension have been used     worldwide as metabolic syndrome to predict cardiometabolic risk. Thyroid dysfunction impacts     on various levels of these components.      Recent evidence from HepG2 cells indicates that betatrophin, also known as     TD26/RIFL/lipasin/ANGPTL8/C19orf80, a secreted protein that regulates glucose, lipid     metabolism, and energy homeostasis, is induced by T3. However, the role of betatrophin in     hyperthyroid patients is unknown.      The objective was to study serum betatrophin levels in hyperthyroid patients and the     association of serum betatrophin levels with hyperthyroidism.   "
36130|NCT02812875|"     CA-170 is a rationally designed and orally available, small molecule that directly targets     the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell     activation (VISTA) immune checkpoints and results in activation of T cell proliferation and     cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered     CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are     non-responsive to available therapies and for which no standard therapy exists.   "
36131|NCT02812862|"     The aim of this study is to evaluate the pulmonary and cardiac effects of a LABA / LAMA     combination therapy in patients suffering from both chronic heart failure and chronic     obstructive pulmonary disease.      The secondary aim of the study it to assess the safety of the LABA / LAMA combination.   "
36132|NCT02812849|"     The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for     diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.   "
36133|NCT02812836|"     Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that     measures pressures along the anal canal in a very detailed manner. It provides complete data     about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon     expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet     obstruction.      Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the     correlation between this diagnostic equipment.   "
36134|NCT02812823|"     Pressures measured by manometric solid-state catheters may differ according to the type of     the catheter and specific anatomy and physiology of anorectum.      The aim of the study is to establish the difference in recordings between 2 types of     anorectal catheters used in pediatric patients and to validate the most appropriate way to     diagnose of functional disorders.   "
36153|NCT02812576|"     Data on neonatal GBS disease are very limited in China. Acceptance and implementation of     prevention measures such as antibiotics prevention or vaccination against GBS disease would     require robust data. This study as the first national, multicenter study to investigate the     epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to     appraise the necessity of appropriate interventions.   "
36135|NCT02812810|"     The fight against smoking is a public health priority. Without help, fewer than 5% of des     smokers are abstinent at 12 months after smoking cessation.      Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of     success at 12 months in patients dependent on nicotine is only 18%. Moreover, other     therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.      The investigators propose a new therapeutic strategy for smoking cessation, which is based on     associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with     rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish     craving for tobacco). The principal objective is to improve the success rate for smoking     cessation attempts in patients who are highly dependent on nicotine, and who have failed     using usual smoking cessation strategies.   "
36136|NCT02812797|"     The purpose of this study is to determine whether expressions of adipokines can provide     prognostic information concerning patients with chronic heart failure.   "
36137|NCT02812784|"     Patients with septic shock in the intensive care unit have an elevated risk of developing     acute kidney injury (AKI). AKI is an independent factor for mortality. Interventions that     limit the worsening of renal function might have an impact on the mortality rate in these     patients. Given the absence of validated pharmacological treatments for limiting the     progression of AKI or for accelerating recovery from AKI, early intervention and the     restoration of the glomerular filtration rate (GFR) in this context of hemodynamic change     during the initial phase of septic shock might improve the patients' prognosis. One major     challenge is therefore how to determine whether or not the AKI is reversible. The     best-studied biomarkers (NGAL and KIM 1) have little discriminant power in septic patients     because of their poor specificity or unsuitable kinetics for very early diagnosis. The     combination of urine assays for tissue inhibitor of metalloproteinase 2 (TIMP2) and     insulin-like growth factor binding protein 7 (IGFBP7) has shown good diagnostic performance     for the very early detection of the risk of developing AKI in the following 12 hrs. Urine     levels of these two markers specifically reflect damage to kidney tubules. Moreover, the     levels appear to be strongly correlated with the severity of tubule damage. Thus, one can     reasonably hypothesize that measurement of these markers in the very early stages of septic     shock might determine the presence and severity of kidney tubule damage. A threshold (yet to     be defined) would help to differentiate between (i) transient, non-severe injury and (ii)     injury that is already too severe to be reversible.   "
36138|NCT02812771|"     Safety and PK of a once daily topical application of efinaconazole in the treatment of     pediatric subjects with mild to severe onychomycosis of the toenails.   "
36139|NCT02812758|"     Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse     pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly     predictive of the response to vascular filling in sedated, mechanically ventilated patients.     However, the influence of the sedation depth on these dynamic indices has never been     evaluated.   "
36140|NCT02812745|"     Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be     justified by the agreement between various clinical situations in which BIS monitoring     appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death     , and the diagnosis of amniotic fluid embolism. The current controversy concerning the     triple low state reinforces the need for an accurate study in this field. Furthermore, the     recent review by Bidd argues in this sense.   "
36141|NCT02812732|"     After completing over 600 interviews with parents, adolescents, and clinicians to determine     reasons why HPV vaccines are used or not used, the investigators recently piloted a     communication-based educational intervention with healthcare clinicians to improve     communication around HPV vaccination. The intervention combined education and quality     improvement methods using a mechanism called Performance Improvement Continuing Medical     Education. This type of intervention is attractive to clinicians because they improve their     cancer prevention practices while fulfilling requirements for maintaining board     certification. The intervention consists of seven education and feedback sessions along with     baseline and follow-up chart reviews and facilitated group discussions of clinician and     practice vaccination rates. The pilot intervention was effective: at the two pilot     intervention sites, girls were 60% and boys were 15 times more likely to receive HPV     vaccination than at control sites both during and after the intervention period.      The goal of the proposed research is to broadly test the intervention's effectiveness in a     diverse group of pediatric and family medicine practices serving low-income and minority     patients. First, the investigators will perform a randomized trial in five community health     centers to determine the effectiveness of the intervention. Second, the investigators will     examine what made the intervention successful and identify barriers to sustainability with     the goal of ensuring that the intervention can be successfully replicated in other settings.     Third, the investigators will explore the effects of the intervention on parent-clinician     communication by surveying parents and clinicians and observing clinical encounters when     vaccination is discussed.      The proposed intervention represents an innovative and scalable model for promoting cancer     prevention and screening activities by clinicians. Unlike programs that increase     administrative burdens on busy clinicians, the proposed intervention allows clinicians to     improve cancer prevention practices while simultaneously fulfilling requirements to maintain     their board certification and improving the quality of cancer prevention care. It therefore     has great potential for widespread dissemination.   "
36142|NCT02812719|"     The aim of this pilot study is to conduct a controlled comparison of the efficacy and safety     of a combination peel (glycolic acid and salicylic acid) as compared to glycolic acid peel     alone in the treatment of melasma. Our primary outcome is objective improvement in     pigmentation as evaluated using a colorimeter. Our secondary outcomes are subjective     improvement using the Melasma Area and Severity Index (MASI) and Patient and Physician Global     assessment, as well as assessment of treatment tolerability and patient satisfaction.   "
36143|NCT02812706|"     Primary Objectives:        -  Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with          relapsed and refractory multiple myeloma.        -  Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate          the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and          refractory multiple myeloma.      Secondary Objectives:        -  To evaluate the safety including immunogenicity of isatuximab. The severity, frequency          and incidence of all adverse events will be assessed.        -  To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing          schedule.        -  To assess the efficacy using International Myeloma Working Group (IMWG) uniform response          criteria.        -  To assess the relationship between baseline CD38 receptor density on multiple myeloma          cells and efficacy.   "
36154|NCT02812563|"     The principal objective of this study is to evaluate the frequency of KC inside family of     patients with confirmed KC.      It's a familial, epidemiological, prospective, single-center study.   "
36155|NCT02812550|"     The purpose of this study is to compare the adenoma detection rates of full-spectrum     endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening     programme.   "
36144|NCT02812693|"     This phase I/II trial studies the side effects and how well pembrolizumab and imatinib     mesylate work in treating patients with melanoma with c-KIT mutation or amplification that     has spread to nearby tissue or other places in the body. Monoclonal antibodies, such as     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Imatinib     mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving pembrolizumab and imatinib mesylate may work better in treating patients with     melanoma with c-KIT mutation or amplification that has spread to nearby tissue or other     places in the body.   "
36145|NCT02812680|"     Circulating microRNA (circ miRNA) and circulating tumor cell (CTC) levels are hypothesized to     be associated with response to chemoradiation in patients undergoing treatment for locally     advanced esophageal adenocarcinoma.      The goal of this project is to assess the use of circulating microRNA (miRNA) and circulating     tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.   "
36146|NCT02812667|"     The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an     effect on cancer and body in combination with nivolumab, a standard treatment for metastatic     squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.      Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to     the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that     is not approved for use outside of research studies by regulatory agencies. Up to 38 patients     will be enrolled.   "
36147|NCT02812654|"     Prospective phase II study. Patients will be submitted to neoadjuvant chemotherapy (cT) and     hypo fractionated radiotherapy (hRT) following by surgery. The remain viable cells will be     analyzed and the patients whithin less than 30% will receive more 3 cycles of cT. All     patients have deep high grade soft tissue sarcoma of extremity.   "
36148|NCT02812641|"     Esophageal squamous cell carcinoma (ESCC) is one of the ten leading cancers in Taiwanese     male. The prognosis is poor with a five-year overall survival rate of 10 to 30 %. Randomized     clinical trials have demonstrated that trimodality therapy (TMT), consisted of neoadjuvant     concurrent chemoradiation (CCRT) and radical esophagectomy, improves the overall survival for     patients with locally advanced disease. Despite of the advancement, the outcome remained     unsatisfactory with the median progression-free survival around 20 to 25 months and median     overall survival around 30 months. It is know that the most important prognostic factor is     whether a pathological complete response can be achieved after neoadjuvant CCRT. However, the     use of new generation chemotherapeutic agent taxanes and epidermal growth factor inhibitors     (such as Cetuximab) failed to significantly improve prognosis comparing to the standard     platinum-fluorouracil (PF) regimen. As a consequence, it is mandatory to develop new     chemotherapeutic regimen for CCRT.      In previous prospective studies, investigators used proximal ligation assay technology to     identify serum VEGF-A in correlation with the pathological response and prognosis for     patients receiving neoadjuvant CCRT plus radical esophagectomy for locally advanced ESCC.     Other investigators also showed high VEGF expression correlating to poor outcome. Therefore,     investigators generate the hypothesis that adding vascular endothelial growth factor (VEGF)     monoclonal antibody, Bevacizumab, to standard neoadjuvant CCRT may improve outcome for     patients with ESCC. Meanwhile, several prospective clinical studies have shown the     feasibility, safety, and activity of adding Bevacizumab to chemotherapy, CCRT, or combined     modality therapy including surgery, either in head and neck cancer, esophageal cancer, or     esophagogastric junction adenocarcinoma. However, its efficacy should be further investigated     in larger prospective trials and little is known about the activity and toxicity of     Bevacizumab in ESCC due to small number of reported cases. In the present clinical trial,     investigators plan to investigate whether incorporation of Bevacizumab into standard     neoadjuvant PF-CCRT will improve treatment response and increase pathological complete     response rate. Investigators will also evaluate associated biomarkers in relation to     prognosis. By the present research, investigators expect to develop a new TMT regimen for     this poor prognostic disease.   "
36149|NCT02812628|"     This study is designed to compare the short-term and long-term benefits between conventional     laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal     individualized levator transection (TILT).   "
36200|NCT02811939|"     The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the     acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will     be tested by pretreating healthy individuals with PREG, and then assessing their responses to     Dronabinol (THC).   "
48448|NCT02651467|"     This will be a single center, eight week, randomized, double blind, three treatment arm,     parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected     test teeth) study in healthy participants.   "
36150|NCT02812615|"     This is a community-based intervention study which will be undertaken at Mirpur, Dhaka,     Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18     months) and an adult cohort (age 18 to 45 years). The child cohort will consist of stunted     children (length for age Z score, LAZ < -2), children who are at risk of stunting (length for     age Z score <-1 to -2) and child controls. The adult cohort will consist of malnourished     adult cases (Body Mass Index <18.5) and adult controls. After screening the participants for     any organic diseases and application of inclusion/exclusion criteria, they will receive     nutrition interventions. Participants eligible for study will be tested for potential bio     markers of environmental enteropathy (stool, urine and serum) once before and once after the     nutritional intervention. Participants who will fail to respond to nutritional therapy     (measured by anthropometric assessment) will become candidates for upper gastrointestinal     endoscopy with biopsy. The study will include duodenal biopsies from a control group of     children from University of Virginia Hospital in Charlottesville, Virginia who will undergo     upper GI endoscopy as part of their clinical care as per the standard clinical protocol     followed at the hospital. Adult controls (BMI > 18.5) for endoscopy will be collected from     international centre for diarrhoeal disease research,Bangladesh staff clinic, Dhaka Medical     College and Hospital (DMCH), Dhaka and Bangabandhu Sheikh Mujib Medical University (BSMMU),     Dhaka.   "
36151|NCT02812602|"     Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples     after total knee replacement   "
36152|NCT02812589|"     The breast MRI is used in the preoperative scenario to evaluate the extension of a newly     diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series     of images taken after the use of intravascular contrast media that may detect areas of     enhancement that look malignant, but are actually benign tissue, producing a false positive     result. The investigators aim to evaluate a novel MRI sequence of images that does not use     contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly     to the time of standard breast MRI exam. This novel technique provides improved detection of     tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the     investigators hypothesize that DTI may decrease the false positive rate when compared with     standard dynamic contrast-enhanced (DCE) MRI.   "
37044|NCT02800798|"     The purpose of this study is to find the correlation between high risk OSA (obstructive sleep     apnea) patient, based on Stop-bang screening tool and preeclampsia   "
36156|NCT02812537|"     Conduct disorders are defined as repetitive and persistent pattern of behavior in which the     basic rights of others or major age-appropriate norms are violated. So defined, these     disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder     management is a public health issue and a societal question. Conduct disorders affect 5 to 9%     of 15-year old boys.      Care management of children and adolescents admitted for disruptive behaviors in emergency     rooms is an issue. No consensus or official recommendation exists. However, use of emergency     care in this context is increasing in most western countries and it exposes to several risks     (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and     suicide risk). The Trajectories project is designed to describe children and adolescents with     disruptive behaviors, their care management and to follow their life trajectory and     psychiatric evolution after admission to emergency rooms. Better understanding this     population will improve their medical and social care management, thereby giving     professionals the right tools.      The main objective of this project is to implement a multidisciplinary and integrative     research combining clinical considerations and social sciences to determine the trajectory     of this population.   "
36157|NCT02812524|"     This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This     study will test the feasibility of the administration of intratumoral injections of     ipilimumab prior to surgical resection, and the immune system response to treatment.   "
36158|NCT02812511|"     The objective is to collect skin biopsies rom patients with Costello syndrome to analyze the     molecular mechanisms responsible for this syndrome caused by a mutation in the HRAS gene and     the effects of this mutation on energy metabolism and mitochondrial physiology.   "
36159|NCT02812498|"     The purpose of this study is to compare the effects on glycemic control of Teleconsultation     versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.   "
36160|NCT02812472|"     The purpose of this study was to investigate the effects of the treadmill training with     functional electric stimulation on sensorimotor cortical reorganization and functional     improvement in subjects with chronic stroke.   "
36161|NCT02812459|"     The purpose of this study is to analyze the effectiveness of electrical stimulation and     kinesio taping in combination with exercise in People with Chronic Low Back Pain   "
36162|NCT02812446|"     The purpose of this study is to identify bacterial and/or clinical features involved in the     pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials &     methods: In total, 57 IAI S. aureus and 31 nasal carriage (NC) S. aureus isolates were     studied. Staphylococcus aureus genetic background was obtained by microarray analysis.     Multilocus sequence typing was performed to determine clonal complexes (CC). Biofilm     production was investigated by resazurin and crystal violet methods   "
36201|NCT02811926|"     The purpose of this study is to use routinely-collected health data from registers to examine     the incidence of parastomal bulging (PB) at different time points in the first year after     surgery for ileostomy or colostomy. Additionally, the purpose is to investigate risk factors     for development of PB.   "
42423|NCT02730364|"     The purpose of the study is to assess the short term efficacy of the Theraflu Night powder     for oral solution in the Russian population in Short term relief of the symptoms of colds,     chills and influenza, including mild to moderate pain, fever and nasal congestion.   "
36163|NCT02812433|"     Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious     condition causing significant mortality and long-term morbidity, including cerebral palsy and     mental retardation. Currently, no treatment exists to repair brain injuries secondary to     neonatal asphyxia. The only available treatment for this condition is hypothermia that may     prevent but not repair the development of brain injury. The success of this therapy is     limited.      Sildenafil already is used with some newborns for other purposes (i.e., persistent pulmonary     hypertension), but, surprisingly, its effect on the newborn brain has never been studied     systematically. The findings of the investigators in the rat model of term neonatal     encephalopathy demonstrated that the administration of sildenafil following asphyxia promotes     brain injury recovery. Thus, the investigators hypothesize that sildenafil may improve     neurodevelopmental outcome in term asphyxiated newborns, in whom hypothermia treatment has     failed to prevent the development of brain injury.   "
36164|NCT02812420|"     The goal of this clinical research study is to learn if the combination of durvalumab and     tremelimumab is safe and tolerable when given to patients with bladder cancer before surgery     to remove the bladder.   "
36165|NCT02812407|"     Does baseline impedance measured during the landmark phase of esophageal High resolution     impedance manometry HRIM correlates with direct mucosal impedance measurement and     discriminates GERD from non GERD patients?   "
36166|NCT02812394|"     This study will be an open-label, randomized, three-period cross-over pharmacokinetic     evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered     carbidopa/levodopa, in healthy volunteers.   "
36167|NCT02812381|"     The suture of the supraspinatus tendon is a common surgery that requires physical therapy for     back pain and functional impairment to such surgery. Kinesiotaping technique (KT) is being     used to treat myofascial trigger points that appear after surgery and for the treatment of     physiotherapy in the supraspinatus muscle and deltoid.      To evaluate the effectiveness of KT technique over the technique of Jones     (Straincounterstrain or SCS) in patients undergoing suture the tendon of the supraspinatus     muscle.   "
36182|NCT02812186|"     This is a two period cross-over study randomizing patients undergoing laparoscopic surgery     into 2 different groups: group 1 in which patients receive deep neuromuscular blockade in     the beginning portion of their laparoscopic surgery followed by a period of moderate     blockade and, group 2 in which patients receive moderate neuromuscular blockade in the     beginning portion of their laparoscopic surgery followed by a period of deep blockade. The     deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate     neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to     reverse the block at the end of surgery in order to obtain optimal extubating conditions.   "
36218|NCT02811705|"     This cohort study aims to assess the quality of life (or welfare) related to the health of     children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall     syndrome to compare it to children or adolescents with recurrent fever genetics of Familial     Mediterranean fever (FMF) in order to improve their overall care.   "
36168|NCT02812368|"     Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD)     and is the source of considerable stress for the affected individual and family. Sleep plays     a role in development and learning processes; thus, the appropriate treatment of sleep     disturbance is paramount to optimal outcomes. The empirical base for treatments to address     sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to     target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep     disturbance in children with ASD will allow investigators to evaluate the feasibility of     conducting a much larger multisite trial to address the general lack of systematic data     available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive,     with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO),     parallel groups study will test the efficacy of CLN following a brief sleep hygiene     intervention. Outcome measures include: informant completed sleep questionnaires, daytime     behavior questionnaires, and actigraphy. Biomarkers for medication response will include     galvanic skin response and skin temperature. Side effects will be monitored throughout the     study.   "
36169|NCT02812355|"     The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded,     unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is     designed to test in patients undergoing off-pump coronary artery bypass surgery the     hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are     not different in terms of thrombotic complications and major perioperative bleeding events     (null hypothesis).   "
36170|NCT02812342|"     The purpose of the study is to investigate the use of topical tofacitinib to promote hair     regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.   "
36171|NCT02812329|"     This study aims to minimize risk of human immunodeficiency virus (HIV) in adolescent boys and     girls, ages 15-16, by promoting HIV testing and counseling (HTC) through the use of an     interactive videogame. With input from focus groups of adolescents, the investigators will     adapt an HIV prevention videogame, PlayForward: Elm City Stories, for adolescents ages 15-16     . The investigators will then pilot test the videogame in 30 adolescents to assess the     acceptability and feasibility of the videogame. They will also assess whether the videogame     increased the participants' intentions to obtain HTC, whether they actually obtained HTC, and     whether the videogame increased knowledge of HIV.   "
36172|NCT02812316|"     Study to evaluate the safety and efficacy of HI-BRITE large diameter rigid gas permeable     contact lens (hexafocon b) test when worn on a daily wear basis in the correction of     myopia/hyperopia/astigmatism/presbyopia/ and irregular cornea.   "
36173|NCT02812303|"     A pilot program was created by the network's primary care leadership team at Massachusetts     General Hospital. A population health management program was implemented for chronic disease     management. The investigators evaluated quality of care process and outcome measures over the     first six months of the program and compared practices assigned a central population health     coordinator to those not assigned this support.   "
36174|NCT02812290|"     Objective: To evaluate the potential impact of molecular phenotyping of transbronchial     biopsies in lung transplant recipients with allograft dysfunction, and the potential for     developing a safer endobronchial mucosal biopsy format.   "
36175|NCT02812277|"     This is a single centre, observational and retrospective clinical study. The study group was     about all HR positive postmenopausal breast cancer patients who were hospitalized between     January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up     data.   "
36176|NCT02812264|"     This study will test the effectiveness of a mobile application that uses an Application     Program Interface (API) to distribute evidence-based weight loss interventions. Half of the     participants will receive this API-based application, and the other half of the participants     will use a non API-based application.   "
36177|NCT02812251|"     The purpose of this study is to investigate the safety and tolerability of JNJ-61393215     versus placebo after single oral dose administration under fasted (ascending dose levels) and     fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal     fluid (CSF) and urine after single oral dose administration and to investigate the effect of     food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral     dose administration.   "
36178|NCT02812238|"     Background:      The immune system controls how the body responds to infection or injury. Researchers want to     see what effect a dietary supplement called nicotinamide riboside (NR) has on the immune     system. A study showed that fasting has a good effect on immune cell health in healthy     people. And when immune cells were exposed to NR they had a similar positive response as with     fasting. Researchers want to see if healthy people have the same effects from NR and fasting,     and if those effects last.      Objectives:      To see if taking nicotinamide riboside will have the same healthy immune system effects as     fasting. To see if these good effects continue even after eating again.      Eligibility:      Healthy volunteers ages 18 39      Design:      Participants will be screened with medical history, physical exam, and blood tests. Women     will have a urine pregnancy test.      Participants will take 4 pills of either NR or a placebo once a day for 1 week.      On day 6, they will not eat or drink anything.      On day 7, they will have a study visit to give a blood sample before and after eating a meal     at the clinic.      They will also give a urine sample.      Participants will stop taking the pills for 1 2 weeks.      Participants will take either NR or a placebo once a day for 1 week.      They will repeat day 6 and day 7 of the first week.      Participants will get NR once and placebo once, but will not know which they are taking.   "
36179|NCT02812225|"     The multi-center study evaluates BrainPulse recordings from subjects with a suspected or     confirmed concussion to improve a concussion detection algorithm. Subjects may also consent     for a 5 additional follow-ups over a 21-day period to compare the progression of change in     their BrainPulse recordings.   "
36180|NCT02812212|"     Cortical transit time on diuretic renogram as an early marker of significant obstruction in     antenatally detected uretero-pelvic junction syndrome   "
36181|NCT02812199|"     This is a randomized controlled first in man study. Study purpose is to assess safety and     efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus     surgery in terms of:        -  Sinus tissue adhesions        -  Middle turbinate lateralization into nasal septum i.e. postoperative opening reduction        -  Inflammation   "
36183|NCT02812173|"     The purpose of the study is to determine, whether the postoperative quality of micturition     and continence can be improved depending on the urinary drainage catheter and retention after     robot assisted radical prostatectomy. Another finding could be the study of the pain     assessment of the patient, as well as the pain medication at the various derivatives. Further     check whether infections and the presence of bacteriuria can be reduced or avoided by the     form of urinary drainage.   "
36184|NCT02812147|"     This research study is being done to determine whether treatment with L-     Dihydroxyphenylserine (L-DOPS) versus placebo (an inactive substance that looks like study     drug) in addition to other Parkinson Disease (PD) drugs will improve balance, walking, and     reduce risk of falls and/or severity of falls in PD subjects. The study is also being done to     determine the effectiveness, safety, and tolerability of L-DOPS, and whether it will decrease     Freezing of Gait (FOG), improve apathy (generalized disinterest) or show a relationship     between apathy and slowed movement and fall risk.   "
36185|NCT02812134|"     Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by     osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and     inhibition of 1,25-OH vitamin D).      There are no published studies on the role of FGF23 in undernourished anorexic adolescents     taking oral phosphorus supplements.   "
36186|NCT02812121|"     Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease     with high mortality. Our previous study have demonstrated that peripheral infusion of bone     marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24     weeks survival rate of ACLF patients. In this study, we intend to assess the safety and     efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.   "
36187|NCT02812108|"     This study was designed to collect a large series of patients with aneurysms treated     endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.   "
36188|NCT02812095|"     Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end     of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance,     cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the     efficacy and safety of the practice of refeeding in preterm infants with enterostomy.     Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other     laboratory findings will be collected. Serial citrulline levels during refeeding procedure     and pathologic specimens of bowel (at the time of stoma closure) will be collected for     evaluating bowel adaptation.   "
36189|NCT02812082|"     The purpose of this study is to develop an interactive web-based patient education program to     help educate patients about the increased risk of MS and its cardiac risk factors following     allo-SCT and to inform and motivate patients how to make lifestyle changes. This program will     be used in addition to counseling at participants clinic visits. The investigators are not     changing the recommendations for prevention and management of these conditions, but rather     are trying to improve the way they provide this education to patients.   "
36250|NCT02811263|"     Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen     to the brain near the time of birth. This results in death or neurologic disabilities     including cerebral palsy and cognitive impairment in up to half of affected infants. This     clinical trial will determine if the drug erythropoietin (Epo) added to hypothermia (usual     therapy) will improve outcomes for infants suffering from HIE.   "
44410|NCT02704403|"     The primary objectives of this study are to evaluate the effect of Elafibranor treatment     compared to placebo on 1) histological improvement and 2) all-cause mortality and     liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.   "
36190|NCT02812069|"     Hypothermia during surgery and in the postoperative period is associated with adverse     outcomes including impaired drug metabolism, cardiac morbidity, shivering, impaired immune     function, coagulopathy, and increased use of hospital resources. Several clinical studies     have demonstrated that maintenance of normothermia during the perioperative period     significantly reduces morbidity.      Mercury Biomed has developed a patient-warming system, WarmSmart, that potentially transfers     adequate heat through hands and feet based on the physiological principle of peripheral     arterio-venous shunt vaso-dilation. The technology works as a two-step process by selective     thermal stimulation along the spinal cord to up-regulate blood flow to arterio-venous shunts     and triggering arterio-venous shunt vasodilation and by applying circulating water heat     exchangers to the palmar and plantar glabrous skin to warm highly perfused shunts in that     area.      General anesthesia reduces the vasoconstriction threshold (triggering core temperature) by     1-2°C, thus promoting arteriovenous shunt dilation. It remains unknown, though, whether     cervical spine warming further augments arterio-venous shunt dilation during general     anesthesia. If spine heating proves unnecessary under anesthesia, Mercury Biomed's WarmSmart     warming could be simpler and less expensive. Investigators therefore propose to test the     hypothesis that cutaneous heating near the cervical spine does not further augment     arterio-venous flow in fingers during general anesthesia.      Investigators propose to enroll ten patients. The patients will be pre-warmed and warmed     intraoperatively with forced-air to maintain a core temperature near 36°C.      A ThermaZone® Device capable of heating the cervical spine area will be positioned behind the     patient's neck upon arrival in the operating rooms. Additionally a forced-air warmer will be     positioned appropriately and activated as soon as practical, usually after prepping and     draping. Ambient temperature will be maintained near 20°C.      After about one hour of anesthesia when temperature and other factors are stable,     investigators will start a 30-minute observation period. Thereafter investigators will     activate the cervical spine warming system for 30 minutes (warming measurement period) and     thereafter have a 30 minutes control period again.      Measurements will be recorded such as mean-skin temperature, distal esophageal temperature,     MAC fraction, mean-arterial pressure and finger blood flow.   "
36191|NCT02812056|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of alisertib and TAK-228 that can be given to participants with advanced solid     tumors that are associated with HPV. Researchers also want to learn if the study drug     combination can help to control advanced solid tumors.   "
36192|NCT02812043|"     This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser     and the combination between amorolfine and long-pulsed Nd:YAG in treating the     non-dermatophyte and mixed-infection onychomycosis.   "
36205|NCT02811874|"     The aim of this study is to evaluate the effect of a diabetes education program delivered to     CHW in improving the metabolic control of patients with type 2 DM.      The study is a randomized controlled trial conducted in a primary care unit. Eight CHW,     providing care for 118 patients, are randomized in two groups to receive a one-month diabetes     education program (intervention group, patients n= 62) or an education course in other health     issues (control group, patients n= 56).   "
36206|NCT02811861|"     This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and     safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus     sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.   "
36193|NCT02812030|"     Diabetic retinopathy remains the leading cause of blindness in patients of working age in the     Western World, and there is a global epidemic of diabetes. The recommended treatment for     diabetic retinopathy involves injection of anti-vascular endothelial growth factor     (anti-VEGF) into the eye. Based on two recent clinical trials taking place in the United     States, Europe, Japan, and Australia, NICE issued guidance in July 2015 recommending that     aflibercept (a particular type of anti-VEGF treatment) should be available on the NHS for     patients in whom the central retina of the eye is at least 400 micrometres thick before     treatment.      Real-world data can differ significantly from clinical trial data, and it is therefore very     important to evaluate the impact of aflibercept in a real world setting, particularly with     respect to systemic control, as patients with poor systemic control were excluded from the     clinical trials. This study aims to demonstrate the efficacy of aflibercept in a real-world     setting, and how this compares to the clinical trial setting.   "
36194|NCT02812017|"     This comparative study of will evaluate the effectiveness of promoting critical language and     cognitive development in infants of low-SES English- and Spanish-speaking parents. TMW-WB     will target infants zero to six months and their parents during routine Well Baby pediatric     visits at one week, one month, two months, four months, six months, and a final nine month     follow-up.   "
36195|NCT02812004|"     The Ultra Q Reflex® (Ellex) constitutes the only Nd:YAG laser approved for the treatment of     vitreous floaters. No randomized controlled clinical trial has been carried out to this day     in order to investigate its superiority over sham treatment.      In the present study, 60 eyes will be randomized and blinded into 2 groups, one receiving up     to two sessions of laser vitreolysis the other scheduled for two sessions of sham treatment.     After a maximum of two (sham) treatment sessions (1 per month), patients' utility value score     and BCVA will be re-assessed. A follow-up period of 12 months (with visits at month 1, 6 and     12 post-treatment) will ensue the treatment phase to register any late adverse events that     may be associated with laser vitreolysis.      As vitrectomy constitutes a highly invasive procedure, which must therefore be restricted to     severe cases only, laser vitreolysis may present a valuable treatment option for patients     with moderate vitreous floaters that are not eligible for vitrectomy.   "
36196|NCT02811991|"     Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal     analgesia. This medication is generally safe, well tolerated and effective within recommended     daily dose.The purpose of the study is to evaluate the efficacy and safety of Paracetamol     Injection as adjuvant to morphine-based post-operative analgesia, as well as to explore the     reasonable dosage of paracetamol among Chinese population under above-mentioned circumstance.   "
36197|NCT02811978|"     The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to     intravenous velcade when administered in combination with low-dose dexamethasone in chinese     refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall     response rate after 4 cycles of velcade and dexamethasone administration.   "
36198|NCT02811965|"     Prevention of heel pressure ulceration is a major clinical concern. Clinical research has     shown that heel-offloading devices are effective at preventing heel ulceration when compared     to no offloading or sub-optimal offloading methods (i.e. use of a hospital pillow to offload     the heel). As a result, a plethora of heel-offloading devices have been developed that     utilize different designs and materials to offload the heel. Despite the availability of     these devices, some healthcare facilities still employ no heel offloading or utilize     sub-optimal heel offloading strategies. It is also difficult for clinicians to compare the     effectiveness of different heel offloading device without conducting extensive clinical     evaluations. Pressure mapping of the pressure experienced by the heel while offloaded offers     a potential method to assess the effectiveness of different heel offloading strategies.      The primary hypothesis of this study is that the three tested heel offloading devices will     significantly decrease the heel contact forces compared to no offloading and sub-optimal heel     offloading conditions. The secondary objective is to quantify differences in heel contact     forces experienced by the heel when placed in each heel offloading device to demonstrate the     utility of pressure mapping as a tool to evaluate the effectiveness of different heel     offloading devices.      The study will recruit 21 healthy volunteers as research subjects with 7 having a normal BMI,     7 having an overweight BMI, and 7 having an obese BMI. Pressure mapping will be conducted on     each research subject for seven randomly applied conditions while the patient lies     comfortably in a hospital bed. The seven conditions include no heel offloading, 3 sub-optimal     offloading conditions, and offloading in 3 different heel-offloading devices. Pressure     measurements corresponding to the heel will be used to determine the average peak pressure     contact force for each research subject in each condition.   "
36199|NCT02811952|"     In many of urothelial carcinoma patients, one does not find common risk factors such as     smoking. The medical center is located in an industrial city with known air and water     pollution. The investigators decided to check the presence of nano particles and traces of     metals in urinary samples of patients known and suspected for urothelial carcinoma and     compare the results to both cystoscopic and cytological findings. The patients will fill a     validated epidemiological respiratory disease survey and the results will be compared to a     control group.   "
36202|NCT02811913|"     Stroke affects over 795,000 Americans every year and has an enormous impact on the well-being     of American Veterans with 6,000 new stroke admissions every year. Many of these stroke     survivors are living with disabilities that limit their everyday function. One of the major     consequences of stroke is loss of sensation which manifests as inability to perceive touch,     temperature, pain or limb movement. Lack of sensation hinders full functional recovery.     Current treatments for sensory loss produce only limited improvements and do not achieve full     recovery. Therefore, it is critical to develop new therapies to re-train sensory function.     The investigators propose to evaluate a novel non-invasive brain stimulation treatment called     repetitive Transcranial Magnetic Stimulation (rTMS). The effects of this technique on motor     deficits following stroke have been studied, however rTMS for the treatment of sensory loss     has not been examined to date. The investigators' study will examine for the first time if     rTMS of a sensory brain region can improve sensory function in chronic stroke survivors.   "
36203|NCT02811900|"     A prospective bariatric database was carried out in the Department of Digestive and Endocrine     Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All     potential candidates for obesity surgery were prospectively registered in the database.     Patients were informed by the bariatric surgeon of the prospective database, and of the     possibility of utilizing personal data for research purpose after anonymization.      A case-control study was performed, to compare the quality of life (QoL) of patients treated     for internal hernia (IH group) with the QoL of patients with an uncomplicated course after     Roux en Y gastric bypass (Uncomplicated RYGB group).   "
36204|NCT02811887|"     To investigate whether simple reminders about healthy lifestyle sent via mobile phone text     messages can improve the liver cirrhosis severity and prognosis (as assessed by the MELD     score supported by the Child-Pugh score) among patients with liver cirrhosis that have been     through a 12-week supervised and facility-based physical exercise training program and     in-patient rehabilitation.   "
36208|NCT02811835|"     Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term     (10-year and longer) results are, however, still disappointing. Where most research has     focused on immunosuppression and infections, the investigators hypothesize that due to poor     homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant     recipients are much more susceptible to poor dietary habits and exposure to potentially toxic     contaminants than people of the general population, and that this contributes to accelerated     function loss of the graft and excess risk of premature mortality, both contributing to poor     long-term results. This study is a biobank and cohort study which investigates this     hypothesis.   "
36209|NCT02811822|"     This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as     adjunct to standard of care chemotherapy used to treat this disease.   "
36210|NCT02811809|"     This study is open to men who have biochemical recurrence (BCR, increased PSA) following     local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard     treatment option, but is only effective for 16-24 months and has a number of side effects     that impact quality of life. These side effects may include fatigue, hot flushing, loss of     sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low     levels of red blood cells that can make people feel tired and weak), diabetes (low blood     sugar), heart disease, metabolic syndromes (sometimes called pre-diabetes and includes     obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood),     and risk of fractures. An alternative to continuous ADT is intermittent administration, where     patients are given breaks from ADT to let their testosterone levels return to baseline.     There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer     time to the development of resistance; (2) improved patient quality of life owing to recovery     from adverse effects, particularly sexual function; and (3) substantial cost savings owing to     less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.      Apalutamide is an investigational drug, which means it has not been approved by the Food and     Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study     is to determine the ability of Apalutamide to extend the time between the first two     injections of leuprolide and improve quality of life. This study will also look at the safety     of Apalutamide and the effects that Apalutamide has on prostate cancer.      Men will be randomized (like flipping a coin) to receive:        -  Group A: Leuprolide + Apalutamide or        -  Group B: Leuprolide only (until second leuprolide injection), then leuprolide +          Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given          as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken          by mouth (4 tablets) daily. Each cycle is 4 weeks long.      Intermittent treatment with Apalutamide + leuprolide will continue until continuous     leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above     undetectable level unless leuprolide is given without pause, every 3 months).   "
36211|NCT02811796|"     The investigators will collect prospectively baseline, procedural and follow-up data of all     patients receiving successful percutaneous coronary intervention (PCI) and stent     implantation. Angio-based flow fractional reserve (QFR system, Medis medical imaging systems     Leiden, The Netherlands) will be estimated in all patients. Especially, the investigators at     the end of the procedure (this is defined according operator's judgement) will record 2     orthogonal angiograms (as suggested by QFR instructions) at 15 frames/second and the same 2     orthogonal angiograms at 30 frames/second. An independent corelab (blinded to procedural data     and clinical outcome) will estimate QFR value (one with the angiograms at 15 frames and one     with those at 30 frames   "
36212|NCT02811783|"     This multi-center, double-blind, vehicle-controlled, randomized crossover design study will     evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the     treatment of pruritus in patients with the mycosis fungoides (MF) form of Cutaneous T-cell     Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug     in a subset of subjects and if so, describe the range and mean plasma levels reached after     two weeks of three time daily (TID) dosing.      Funding Source - FDA OOPD   "
36213|NCT02811770|"     Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This     condition is responsible for 10-15% of glomerulonephritis in children. The outcome is     generally favorable, but up to 5% of patients develop kidney failure. The outcome of patients     with kidney biopsy is less favorable with 7-50% of them progressing to chronic renal failure.      Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at     6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United     Kingdom. The proportion of children with HS who develop renal disease is difficult to     determine because the numbers reported in the literature are variable and depend greatly on     the type of the reporting center, whether or not specialized in pediatric nephrology. Thus     the proportion of renal disease varies from 20% to 100% of children with a HS.      The treatment of HS nephropathy (HSN) usually depends on the severity of histological lesions     but histological classification is discussed and there is currently no consensus. Randomized     studies are scarce and often do not allow to draw clear conclusions. A meta-analysis     suggested a positive effect of corticosteroids on renal prognosis of severe forms but in this     study the definition of renal disease was very heterogeneous. The only classification of the     HSN recognized is from the International Study Group of Kidney Disease in Childhood (ISKDC)     which is the following: grade I: minimal glomerula abnormalities, grade II: pure     proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/ segmental     lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI:     pseudomesangiocapillary. However, this classification is questioned because it ignores other     significant histological lesions such as interstitial fibrosis, tubular lesions, glomerular     and interstitial inflammation, the appearance of crescents (segmental or totally encompassing     the glomerulus, fibrous or cellular), segmental sclerosis, fibrosis and arteriolar appearance     in immunofluorescence.      There is currently no consensus on the criteria indicating the initiation of corticosteroid     therapy whether oral or intra venous bolus. Some patients with severe clinical and / or     histological initial presentation can evolve to remission spontaneously while others who have     more moderate initial symptoms will evolve later to kidney failure. The management is     therefore heterogeneous. In France, some centers perform a kidney biopsy almost always before     starting treatment (or in the days following the start of treatment), while in other     centers's treatment decision is based on the biology resulting from the glomerular disease,     kidney biopsy being performed possibly in a second time in case of failure of the initial     treatment.      Principal objective of the study: assessment of the interest for the long term outcome of     performing early a kidney biopsy (before the establishment of treatment or within 15 days     after the start of treatment) in children with HSN compare to kidney biopsy performed later     (depending on the response to initial therapy) or not performed.      Secondary objective: assessment of the impact of early kidney biopsy (before the     establishment of treatment or within of 15 days after the start of treatment) on the initial     treatment HSN : does it modify or not the treatment started right before it (decided on     clinical and biological criteria).   "
36214|NCT02811757|"     Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often     associated with cuff tendinopathy. The function of the LHB in the shoulder is still     controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii     is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long     head of the biceps permits pain relief and is very reliable in the literature. Two options     are available for the remaining tendon : simple tenotomy or tenodesis which consists to     reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength     or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this     study was to compare the strength and the endurance of the biceps brachii during supination     and flexion after tenotomy or tenodesis of the LHB.      the investigators proposed a prospective and randomized study. All the patients treated in     our department for an arthroscopic rotator cuff repair were included in this study after     signed consent. Participants will complete isokinetic strength and endurance testing for     elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year     after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion     measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.   "
36215|NCT02811744|"     The proposed study aims to use 11C-acetate PET/CT to preliminarily test and validate methods     for imaging astrocyte activation as an early indicator of neuroinflammation in Alzheimer's     disease (AD). 11C-Acetate PET/CT has been shown to quantify astrocyte activation in vivo, but     no reports have evaluated its potential in AD. The investigators propose to test 11C-Acetate     PET/CT as a marker for astrocyte activation associated with pathologic amyloid deposition in     AD. The investigators will compare binding between subjects with early stage AD and healthy     controls. Further, the investigators will investigate the correlation between amyloid and     acetate binding. If the investigators find increased astrocyte activation in response to     cerebral amyloid by showing a group difference in brain acetate uptake between disease and     controls or a strong correlation between acetate and amyloid PET/CT binding. Validating     neuroinflammation markers in AD ultimately may guide therapeutic modulation of beneficial and     damaging neuroinflammation to slow disease progression, as well as providing new insights     into AD pathophysiology.   "
36216|NCT02811731|"     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330     (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of     the two separate drugs in healthy male volunteers.   "
36217|NCT02811718|"     The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious     and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are     deaf or have severe hearing loss using Communication Access Realtime Translation (CART)     and/or American Sign Language (ASL).      This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study     except it is looking at a particular sub-population: patients with NF2 who are hard of     hearing.   "
36219|NCT02811692|"     The French CODEX study is designed as a national database to describe, in routine medical     practice, functional and anatomical responses to intravitreal Aflibercept injection, in a     large population of anti-VGEF-naïve patients presenting with wet Age-related Macular     Degeneration (wAMD), Central Retinal Vein Occlusion (CRVO),Branch Retinal Vein     Occlusion(BRVO), or Diabetic Macular Edema (DME). This national database will gather     databases from French private and public ophthalmologic centers.   "
36220|NCT02811679|"     This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin     Lymphoma (NHL).   "
36221|NCT02811666|"     Sarcopenia (loss of muscle mass and function) can be observed at any age and results of     multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply     impacts the physical performance and the basal metabolism, and induces cardiovascular     disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor     decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing     mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on     postoperative course in digestive oncology. The search for sarcopenia, complementary     nutritional status, is now a source of great interest with 62 ongoing projects in the United     States.      The first objective of this study is to evaluate the impact of preoperative sarcopenia on     30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal     cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative     sarcopenia on the long term outcomes (12 months) on the same patients.   "
36222|NCT02811653|"     In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by     motor slowing) have not been thoroughly characterized.   "
36223|NCT02811640|"     Patients treated with peritoneal dialysis (PD) are at increased risk of developing mechanical     complications such as dialysate leaks and hernias thought to be related to an increase in     intra-abdominal pressure (IAP) secondary to the addition of dialysate to the abdomen.     Resistance training has been shown to increase IAP but it is unclear in the general     population and in patients treated with PD if this training increases the risk of developing     hernias.      This study is observing the difference in IAP pressure measurements obtained by the Stryker     pressure monitor versus the standard IAP pressure measurements obtained with the insufflator     at the time of PD catheter insertion.   "
36281|NCT02810860|"     Collection of PROMs (Patient Reported Outcome Measures) data from patients before and after     an operation to remove their gallbladder for the treatment of symptomatic gallstones. This     PROMs data will provide information to clinicians and trusts about the health gain following     this type of surgery and the impact on patient's quality of life.      This information will be collected by the implementation of the patient Website     aboutmyop.org. This will not only allow patients to complete quality of life (PROMs)     questionnaires online, but will also allow them to access information on their condition and     necessary surgery, in addition to post-operative follow-up.   "
44411|NCT02704390|"     The purpose of this study is to evaluate the long-term safety and efficacy of     ORADUR®-Methylphenidate in children and adolescents with ADHD.   "
36224|NCT02811627|"     Memantine, an N-methyl-D-aspartate receptor antagonist, has been explored as a possible     therapeutic agent that reduces the excitatory (glutamate) - inhibitory (gamma amino-butyric     acid, GABA) imbalance in autism pathology and improves social and communication deficits.     While some studies have shown positive results, a large clinical trial failed to show benefit     possibly because different subsets of autism responded differently to the treatment.      The investigator proposes a pilot, exploratory, clinical follow-on study using proton     magnetic resonance spectroscopy (1H-MRS) to determine whether baseline glutamate/GABA levels     in certain regions of the brain may help predict treatment response to Memantine in autistic     subjects. At study onset, subjects will be assessed on the behavioral scales such as the     Aberrant Behavior Checklist and Clinical Global Impressions scale, followed by MRS imaging.     Memantine treatment will be started post imaging. Assessment measures will be repeated at     week 12 during treatment. Glutamate and GABA levels in brain regions will be correlated to     improvements on assessment measures. Expected results include higher glutamate and/or lower     GABA levels in the anterior cingulate cortex at baseline in responders to memantine. If the     hypotheses are confirmed, it will provide evidence of a relevant neural biomarker to predict     treatment response to memantine with important implications for clinical care including     improving individualization of treatments.   "
36225|NCT02811614|"     The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains     controversial. Two main types of minimally invasive surgery, endoscopic evacuation and     stereotactic aspiration, have been attempted for hematoma removal and show some advantages.     However, prospective and controlled studies are still lacking. This is a multi-center     randomized controlled trial designed to determine whether minimally invasive surgeries will     improve the outcome in patients with hypertensive intracerebral hemorrhage compared with     craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration     group and craniotomy group in a 1:1:1 ratio.   "
36226|NCT02811601|"     This will be a single-arm prospective internally-controlled study. Patients will undergo     percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are     added or substituted for conventional 5 or 10 mm trocars.   "
36227|NCT02811588|"     The prevalence of chronic respiratory disease, including chronic obstructive pulmonary     disease (COPD), is increasing in industrialized countries. Over the next decade deaths from     COPD are projected to increase by more than 30% and COPD will become the third leading cause     of death worldwide by 2030. There is robust scientific evidence that non-invasive ventilation     (NIV) therapy is an effective option for most COPD patients hospitalized with acute     hypercapnic respiratory failure secondary to an acute disease exacerbation. More recently,     NIV has been shown to significantly improve survival and quality of life in COPD patients     with chronic stable hypercapnic disease. These data represent an important advance in the     field, and indicate that usage of NIV in patients with chronic stable hypercapnic COPD should     increase. Such an increase would be expected to improve patient outcomes and have a     beneficial impact on the significant healthcare burden incurred by these patients. However,     the proportion of stable COPD patients with chronic hypercapnia is unknown. In addition,     using NIV at home to treat COPD patients with hypercapnic (type 2) respiratory failure has     not often been considered previously and there is a paucity of data regarding NIV usage     patterns over time in this setting.   "
36228|NCT02811575|"     Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is     difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at     the origin of type 2 diabetes and about its complications could make it possible to improve     the prevention and the treatment of this disease.      Research team developped a new research axis : the microbiota of the intestinal mucosa. They     proved a translocation process of intestinal bacteria from the intestinal mucosa to different     tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the     type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes     and obesity is ongoing.      In parallel, the same team explored the role of intestinal immunity modifications in the     bacteria translocation from the gut to the blood circulation. They already have some results     on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4     Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in     the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity     development and type 2 diabetes.      The aim of this study is to explore this hypothesis in human to have therapeutic solution     later.   "
36229|NCT02811562|"     Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an     important part of training in various medical and surgical specialties such as     anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been shown     that there is a wide variation in the learning curves of residents and the number of attempts     to achieve proficiency in performing upper airway endoscopy. recently, combined use of     fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good alternative.     So, the aim of this study is to compare the number of attempt to achieve proficiency using     fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.   "
36230|NCT02811549|"     The purpose of this feasibility study is to evaluate the benefit of unilateral implantation     in adults who meet conventional indications for implantation in one ear, but do not meet the     conventional indications for implantation in the other ear (asymmetric hearing loss) using     the HiResolution Bionic Ear System.   "
36231|NCT02811536|"     Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases   "
36282|NCT02810847|"     Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally     normal but the vision fails to develop correctly. Around half of these children also have a     squint (strabismus) where each eye has a different direction of gaze. This condition is the     commonest cause of visual impairment in one eye in children.      This is a randomised control trial of wearing glasses alone (which will result in some visual     improvement, termed refractive adaptation) and wearing glasses combined with using I-BiT     Plus.      The hypothesis is that using I-BiT Plus will result in an improved visual outcome.   "
36632|NCT02806219|"     This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects     designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg     when injected by means of a prefilled syringe (PFS, reference) or injected by means of a     injection device (e-Device, test).   "
36232|NCT02811523|"     Sarcoma which has spread to the lungs is most often treated with surgery. Even with surgery,     most patients will not be cured and will die from their disease, probably because of small     cancer cells that are present in the lungs at the time of surgery, but cannot be seen or     detected. It is for this reason that we are looking for a better treatment. Giving     chemotherapy after surgery is generally not recommended because it has significant side     effects and no benefit has been proven.      This study is investigating a new technique for delivering chemotherapy directly into the     lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially     kill any microscopic cancer cells that are present in the lungs at the time of surgery, while     sparing other major organs in the body from the side effects of chemotherapy. This technique     is called In Vivo Lung Perfusion (IVLP). This is a Phase I, non-randomized, dose escalation     study that will act as a pilot study for a larger prospective, multicenter, controlled     clinical trial. Patients who have bilateral disease will have one lung undergo IVLP and the     other lung will remain untreated with the IVLP (the other lung will be treated as current     standard of care - either surgery or radiation) as a control lung. The patients will undergo     a posterolateral thoracotomy. Lung metastases will be identified by visualization or     palpation. After surgical isolation of the lung by proximal control of pulmonary artery and     veins, IVLP will be initiated. After 3 hours of IVLP, the lung metastases will be removed in     the usual fashion. Patients will be cared for post-surgery according to institutional     standards. The patients will be followed for up to 2 years. The primary endpoint is safety.     Secondary endpoints include additional safety endpoints and efficacy.   "
36233|NCT02811510|"     The purpose of the study is to characterize the acute effects of cannabinoids in women     relative to men and to begin probing the mechanisms that may underlie gender differences.   "
36234|NCT02811497|"     This is a phase 2 study of investigational drug, durvalumab given in combination with     azacitidine (CC-486). The main purpose of this phase 2 study is to assess the antitumor     activity of azacitidine in combination with durvalumab patients with microsatellite stable     colorectal carcinoma (MSS-CRC), platinum resistant epithelial ovarian cancer type II (PR-OC),     and estrogen receptor positive and HER2 negative breast cancer.   "
36235|NCT02811484|"     The purpose of this study is to see what the effects of using one or two additional diabetes     drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking     insulin. This research study is being done to investigate which of these commonly-used     medications, medication combinations or increasing insulin dose is better.   "
36246|NCT02811315|"     The objective of the study is to evaluate the effect of frequency of use with a spacer on     asthma control in Dutch patients with asthma during their daily clinical practice over 12     weeks treatment.   "
36256|NCT02811185|"     This is a single-centre, open-label, non-randomized clinical trial designed to monitor the     occurrence of adverse events associated with [F-18]-FDG Injection manufactured by the Fedoruk     Centre. [F-18]-FDG Injection used in this clinical trial will be identical to commercial     [F-18]-FDG that is already used at Royal University Hospital (RUH).   "
37179|NCT02799030|"     This was a placebo controlled, double blind, randomized phase II dose-response study to     evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 -     aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic     keratosis (AK).   "
36236|NCT02811458|"     Anxiety disorders are the most common mental disorders in community settings, and they are     associated with significant psychological distress, functional and social impairment.     Although pharmacological and psychological treatments for anxiety and depression have existed     for several years now, only a minority of anxiety disorder sufferers are treated according to     guidelines. Cognitive behavior therapy (CBT) is the most consistently efficacious     psychological treatment for anxiety disorders, but implementation of CBT in primary care is     challenging due to limited resources. Recent studies indicate that transdiagnostic group CBT     for multiple anxiety disorders could be a promising alternative to individual CBT in primary     care. The aim of the study is to examine the effectiveness of group CBT for anxiety disorders     as a complement to usual care. The clinical trial will be conducted in three Health and     Social Services Centers in the province of Québec (i.e. Sherbrooke, Laval and Québec).     Patients will be French-speaking adults with anxiety disorders, and they will be randomly     assigned to one of two treatment conditions: a) Transdiagnostic group CBT (12 weekly 2-hour     sessions), b) usual care. The transdiagnostic group CBT will be offered as a differed     intervention to participants in the usual care group after the 8-month follow up.     Participants in both study arms will undergo a baseline clinical evaluation as well as     outcome assessment interviews at post-treatment, 4, 8, and 12 month follow-up time-points.     The primary study results will include improvement on a questionnaire on anxiety symptoms.     Widespread implementation of group CBT could lead to better outcomes for a large number of     patients living with anxiety.   "
36237|NCT02811445|"     I recently published significant associations between circulating gut bacteria-related     metabolites with lean and skeletal muscle mass and with measures of physical function in     older adults, evidence that suggests a role for gut bacteria on the maintenance of these     outcomes. To date, studies aimed at identification of associations between gut bacteria with     lean mass or with specific measures of physical function have yet to be reported.     Accordingly, my over-arching hypothesis is that is gut bacteria are associated with and are     causatively involved in mechanisms that underlie the maintenance of lean mass and physical     function in older adults. Results obtained from the proposed study are intended as the basis     for future studies aimed at targeted modulation of the gut microflora, which may be a novel     and innovative means for improving lean mass and physical function and for addressing the     public health priority of healthy aging in older adults.   "
36238|NCT02811432|"     There is uncertainty in the effect of KMC in unstable babies and there is a lack of evidence     to guide how stable an infant must be to gain a mortality benefit from KMC. There is     therefore, a need for a well-designed RCT that initiates KMC within 48 hours after birth to     examine the effect on mortality versus conventional incubator care in infants weighing ≤2000g     who are considered by the responsible clinician to be unstable. We propose such a parallel     group RCT to be conducted at Jinja Hospital, a resource-limited regional referral facility in     eastern Uganda.   "
36239|NCT02811419|"     This study is a randomized controlled trial to determine whether i-scan can improve the     detection of conventional adenomas and sessile serrated adenomas/polyps.   "
36643|NCT02806076|"     The purpose of this study is to prospectively compare the clinical outcomes (local tumor     progression rate, technical success rate, complication rate) of no touch radiofrequency     ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor     puncture RFA technique.   "
36240|NCT02811406|"     Aims: To compare the rates of hypotension in patients with malignancy-related ascites     undergoing abdominal paracentesis with and without prophylactic intravenous albumin infusion      Methodology: Patients with symptomatic ascites secondary to underlying malignancy admitted to     medical oncology inpatient service who require abdominal paracentesis will be enrolled.     Patients with known portal hypertension based on SAAG (>11.1 mmol/L) will be excluded.     Eligible patients are randomized 1:1 to two groups. During drainage of ascites fluid, one     group will receive intravenous albumin infusion (50 ml/Litre of ascitic fluid drained),     whereas the other group will not receive intravenous albumin infusion. Baseline parameters     along with routine 4 hourly monitoring of blood pressure will be done. Episodes of     hypotension (fall in SBP > 20 mmHg) will be compared between these two groups and     significance tested using the chi-square test.      Clinical significance: Ascites often occurs in the setting of advanced malignancy and     drainage of ascites has been proven to provide symptomatic relief in this patient population     with relatively short life expectancy. The use of intravenous albumin infusion is loosely     extrapolated from studies in patients with liver cirrhosis undergoing abdominal paracentesis.     To date, there have been no standard guidelines to guide practice and no studies looking at     the use of intravenous albumin in this population. As the mechanisms of ascites are different     in different malignancies, the indication of intravenous albumin is uncertain and perhaps     unnecessary in this setting. We hope to understand more about the rates of hypotension during     abdominal paracentesis in this population and to generate systematic data to guide clinical     practice in this area.   "
36241|NCT02811393|"     The purpose of this study is to assess muscle function in women at least two years after     being submitted to Roux-en-Y Gastric Bypass Surgery and compare with a control group   "
36242|NCT02811380|"     The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and     performance and compare it to corresponding standard uncoated CVC.   "
36243|NCT02811367|"     The purpose of this study is to find out whether Self-HPV may be an accurate method for the     follow-up of women with a history of HPV infection.   "
36244|NCT02811354|"     Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection     of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR     sensitizing mutations and T790M detected in plasma ctDNA.      This is a prospective, open label, multi-centre single arm phase II study assessing the     efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring     sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and     T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately     106 subjects will be enrolled.      All patients must have documented radiological progression on EGFR-TKI treatment and on the     last treatment administered prior to enrolling in the study.   "
36245|NCT02811341|"     Scopolamine butylbromide might be helpful for the outcome of superior gastrointestinal     endoscope examination.   "
36247|NCT02811302|"     PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary     objective of this study is to derive a score to identify subjects at risk to have respiratory     depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and     monitored by capnography. The score will be derived by using subjects within the derivation     cohort and internally validated using subjects within the validation cohort.      The primary endpoint used to derive the score will be the occurrence of RD episodes derived     by Capnostream 20p device memory data combined with clinical data and validated by an     independent Clinical Endpoint Committee (CEC) during the study course.   "
36248|NCT02811289|"     Lean tissue intracellular triglycerides (ICTG) accretion is an important marker of lean     tissue lipotoxicity that significantly contributes to the development of type 2 diabetes     (T2D). The mechanisms leading to excess exposure of lean tissues to fatty acids involve     metabolic dysfunctions of adipose tissues and lean tissues themselves. Understanding the role     of white and brown adipose tissue in this metabolic dysfunction is particularly important in     predicting, preventing and treating T2D and many of its associated cardiovascular     complications.      A recent breakthrough has been the demonstration that the acute oral administration of a β3     adrenergic agonist, mirabegron (200 mg), significantly increases BAT glucose uptake in     healthy individuals. This suggests that mirabegron could be used as a pharmacological tool to     selectively activate BAT metabolism as part of the mechanistic studies on BAT. It also     suggests that mirabegron could be used pharmacologically for chronic activation of BAT in     clinical trials to treat obesity and T2D. However, there are some outstanding issues     regarding the use of mirabegron to activate BAT. First, there has been no direct comparison     of the effect of acute cold vs. mirabegron on BAT metabolism. Second, there has been no     demonstration of the effect of mirabegron on BAT oxidative metabolism since glucose uptake is     only a surrogate of BAT energy expenditure. Third, acute administration of mirabegron led to     significant increases in blood pressure and cardiac work, suggesting that it may also enhance     energy expenditure in other organs in addition to BAT, thus confounding the role of BAT in     energy homeostasis. Therefore, much remains to be known about the effect of mirabegron on BAT     and cardiac energy metabolism before this drug can be used as a selective activator of BAT     oxidative metabolism. The purpose of this study is to directly compare BAT oxidative     metabolism under cold vs. β3-adrenergic agonist stimulation in lean healthy individuals. The     investigator hypothesizes that the acute oral administration of a lower dose of mirabegron     (50 mg) will result in an increase in BAT oxidative metabolism and whole-body energy     expenditure, to a similar extent as cold exposure, without influencing the cardiovascular     responses previously seen with the higher dose (200 mg).   "
36249|NCT02811276|"     In the 19th century, researchers found out that the differences in the energy content of     macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount     of calories individuals burn per day. It was demonstrated that protein has a metabolic     advantage when compared to the other macronutrients (carbohydrate and fat). Since these     findings, researchers all over the world started to study how diets differing in     macronutrient distribution could result in different responses to energy metabolism. Diets     with high amounts of protein (i.e. meats, eggs, dairy products, and grains) are becoming more     popular, and studies have shown that when people eat high quantities of protein they lose     weight and fat mass, maintain the weight loss, and burn more calories per day.      The investigators hypothesize that giving high amounts of protein to healthy women will     increase the amount of calories and fat they burn per day, increase their satiety, and     improve health markers when compared to a normal diet. The increased protein level will be     achieved using a nutrition supplement consisted of soy protein, yogurt and honey.      To test this, the investigators plan to divide the participants in two groups: one will eat a     normal diet and the other a diet with high amounts of protein during one and a half day.     After one month they will change groups and eat the other diet for the same period of time.     During this period consuming the diets (1.5 days), participants will stay inside a whole body     calorimetry suite, which is similar to a hotel bedroom and is able to inform in the most     precise way the amount of calories participants will burn and if they are burning more fat.     Additionally, before and after each meal participants will have to answer a questionnaire     about their appetite sensations and blood will also be collected to analyze health markers.   "
36803|NCT02803957|"     The objective of this trial is to assess the safety and effectiveness of the study device in     subjects with degenerative mitral valve disease receiving a mitral valve repair without     cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve     repair using standard surgical techniques with cardiopulmonary bypass (control group).   "
36251|NCT02811250|"     Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation     over few fractions (3-6) with great precision. It thus allows tumor ablation and optimal     preservation of healthy tissues. Initially developed in small-sized (<5 cm) lung cancers this     technique it gives results very close and or even equivalent to those of surgery.      Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of     radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall et     al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. In     Cleveland (USA) two phase I studies are already underway.      The investigators propose to develop a phase I study for tumors of less than 4 cm. As found     in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4     to 5 fractions) method for the treatment of renal cancers with a high rate of local control.      The primary objective is to define the maximal tolerated dose for one fraction in     stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:        -  Step 1: 4 x 8 Gy.        -  Step 2: 5 x 8 Gy.        -  Step 3: 4 x 10 Gy.        -  Step 4: 4 x 12 Gy.      The patients will be followed during treatment with evaluation of acute toxicities before     each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6     months for a total duration of 5 years after treatment.   "
36252|NCT02811237|"     Several studies have demonstrated the possibility of outpatient management or early discharge     for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure     is in place.      The approach featured in the most recent guidelines on acute PE of the European Society of     Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism     Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into     account demographics (age), patient history (cancer, cardiac or respiratory disease), and     clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is     offered to low-risk patients, providing that all the conditions pertaining to start     anticoagulant treatment and follow-up at home are met.      An alternative approach based on a list of simple criteria has been developed as the one used     in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the     following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal     or liver failure, or other medical or social conditions requiring hospitalization.      The investigators hereby propose comparing these two approaches in an open-label, controlled     randomized international trial with blinded adjudication of endpoints.      The main objective is to demonstrate, in normotensive PE patients, that a strategy based on     the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe     as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).      The major secondary objectives are to demonstrate, in normotensive PE patients, that a     strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score     is more effective :        -  As regards the rate of patients eventually managed as outpatients.        -  As regards the rate of patients, in theory, eligible for outpatient care,   "
36253|NCT02811224|"     This is a prospective, gold standard observational trial designed to enroll consecutive,     consenting ovarian cancer patients for the purpose of determining sensitivity of an assay     that detects circulating tumor DNA. This observational pilot trial will also be used to     examine the genetic variants/mutations present in the tumor tissue DNA.   "
36254|NCT02811211|"     This noninterventional study will assess genomic changes in the metabotropic glutamate     receptor (mGluR) network in children and adolescents with ADHD.   "
41001|NCT02748954|"     The main goal of this study was to compare the effect of a one-session unsupported Internet     intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related     variables (mood, confidence and motivation).   "
36257|NCT02811172|"     Background Despite of advances in research, at the moment, various points related to the     physiology of gestation and the etiology of severe diseases that can be developed in the     course of it remain unknown. One of those aspects is the behavior of biomarkers     (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a     gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few     days before delivery. Several studies have reported that biomarkers experience a higher     elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia.     The description of their behavior in different population of pregnant women (healthy women     and women at risk) would identify the relation of these with some of the alterations that     occurs more frequently during pregnancy.      Objective The aim of this study is to develop a multi-paradigm biological model of systems to     determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and its     relation with lactogenesis in healthy and risk pregnant women.      Methods A prospective cohort study will take place with women during pregnancy and lactation.     Participating women will be divided into two groups. One group will be integrated by healthy     women and the other group by pregnant women with a risk medical history. The personal, family     and a detailed medical history will be collected in each group. A study of all the variables     which influence the level of the mentioned biomarkers (triglycerides, cholesterol, glucose     and prolactin) will be done.      The universe consists in 4,300 women, who constitute the historical average deliveries during     the semester in the city of Granada (Spain). The sample collection will be made in medical     office's pregnancy control in Granada's hospitals, in their respective health centers and     during the second half of 2015. The sample will be stratified and probabilistic.     Peculiarities of pregnant women will be taken into account when calculating the size of the     study sample. This sample will be made up of 224 women who comply with the inclusion criteria     and that have signed the informed consent.      To achieve the project objectives an organization comprising six theoretical and practical     phases enabling the scientific development of the project.      During the first phase, the technical and administrative preparation of the project is     constructed. Thereafter, the work is divided into two action areas which encompass the     collection and data modeling.      The creation of a biological multi-paradigm computer simulation model of the levels of     biomarkers in different months of pregnancy and in the various pathologies of pregnant women     can be very effective to know the risks that involve high levels of lipids for the mother and     for the baby.   "
36258|NCT02811159|"     To determine the safety of extended treatment with Proellex in women who have successfully     completed either study ZPV-201 or ZPU-203 and meet eligibility criteria.   "
36259|NCT02811146|"     The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation     programs, improvement of exercise tolerance, with consequent reflection in functional     capacity and quality of life of this population.   "
36260|NCT02811133|"     This is an open trial which seeks to determine safety and tolerability of using inositol for     children and adolescents with bipolar disorder and comorbid anxiety disorders with     exploration of efficacy and dose response.   "
36284|NCT02810821|"     Deficiency in gonadal hormone has been considered to play a role in ageing related increased     incidence of cardiovascular events. But the mechanism has not been fully elucidated. On the     other hand, the dramatic increase in gonadotropin level didn't drew much attention when     talking about the increased risk of cardiovascular disease during menopausal transition. This     study aim to investigate the association between gonadal hormone, gonadotropin and long-term     cardiovascular events.   "
36285|NCT02810808|"     The study will evaluate the efficacy and safety of two different dosing regimens of     ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study     is to provide long-term safety data in the treatment of Chinese patients with wet AMD.   "
36261|NCT02811120|"     A previous cohort of 93 clinical trial participants received quadrivalent meningococcal     conjugate vaccine, which includes strains ACW and Y, in their teenage years. The vaccine also     contains components of diphtheria and tetanus which are linked to the meningitis components,     in a process called conjugation, to improve their effectiveness.      Participants are now aged 19-25 and will be invited to take part in this study, which will     assess antibody persistence over time. This will provide information about the duration of     protection by relating current antibody levels to those measured in the previous study, and     will underpin the national immunisation schedule in providing optimal immunisation schedule.     As well as the meningitis antibodies the investigators will assess diphtheria and tetanus     antibody levels.      The study will involve a single blood test of up to 8mL. Participants will be informed of     their results and any with an antibody level that does not infer protection against strain W     will be offered an extra dose of vaccine as part of a duty of care.      The study will involve a single blood test of up to 8mL. Participants will be informed of     their results and any with an antibody level that does not infer protection against strain W     will be offered an extra dose of vaccine.   "
36262|NCT02811107|"     Anxiety is associated with discomfort but also with an increased risk of pain and/or     analgesic consumption. A prescription of anxiolytics is very common in pre-anesthetic     consultation but without considering the real anxiety level of the patients. The objective of     this premedication is mainly to improve patient comfort, to reduce patient anxiety and to     improve patient cooperation.      According to a study conducted in the 1990s, 40 to 80% of patients are anxious before     surgery.      Consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling     asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and     postoperative pain.      Preoperative area is a place of convergence for patients who need surgery or an     interventional procedure.      Staying in the preoperative area may be a source of anxiety and may affect the patient     management.      The investigators will interview patients undergoing surgery or interventional procedure to     assess their level of anxiety, pain and their experiences during their stay in preoperative     area. The objective is to analyse the level of anxiety and / or pain and their clinical     consequences, and then to assess the relationship with any potential premedication.   "
36263|NCT02811094|"     We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence     of flares in patients with SLE that are clinically quiescent at inclusion Systemic Lupus     Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ     damage, and periods of remission. Current biological markers of disease activity are not     sufficient to predict the occurrence of flares, monitor response to treatment or adapt     therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures     in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with     SLE disease activity   "
36264|NCT02811081|"     The aim of this clinical trial is to estimate the efficacy and safety of combined     intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment     maneuver for reducing post-laparoscopic shoulder pain.   "
36265|NCT02811068|"     HPV vaccines have been included in the national immunisation schedule since 2008, firstly as     the Cervarix vaccine which protects against two HPV types and in 2012 as the Gardasil vaccine     which offers protection against a further two HPV types. This study will assess whether     booster doses are indicated to protect females throughout their lifetime or if the     vaccinations offered in early adolescence provide this by following up a cohort from a     previous study where female adolescents were vaccinated 5-7 years ago.   "
36266|NCT02811055|"     Aldosterone regulation is mediated by hormonal control, and nervous control. Autonomic     nervous system action could be mediated by neuropeptides in the adrenal gland. Therefore, in     pathological conditions and especially in diabetes, low-renin hypertension with normal or     high plasma aldosterone could be caused by sympathetic nervous system hypertonia.      Data from the literature and previous in vitro research conducted in the investigators'     laboratory (INSERM U982, University of Rouen) suggest that adrenal corticosteroid secretion     might be controlled by sympathetic nervous system. This neurocrine regulation of     corticosteroid secretion involves locally released neuropeptides. Among them, substance P is     able to stimulate aldosterone and cortisol production via NK1 receptors. A previous clinical     trial conducted at the University Hospital of Rouen, APHOS (NCT00977223) studied the effects     of a NK1 receptor antagonist, aprepitant, on adrenocortical secretions in healthy volunteers.      The aim of the present study is to investigate the effects of a NK1 receptor antagonist,     aprepitant, on adrenocortical secretions in volunteers with diabetes associated with     low-renin hypertension. Aprepitant is a drug already available for the treatment of nausea     induced by chemotherapy.      In the present phase II trial, plasma aldosterone and cortisol levels will be measured under     treatment with aprepitant versus placebo, in both basal conditions and after activation of     the adrenocortical function by upright posture. All volunteers will be given the two     substances (aprepitant and placebo) in a random order during two 14 day-periods separated by     a 21 day-wash-out.      This study should allow to determine the role of substance P in the control of corticosteroid     production in human with diabetes, associated with a low-renin hypertension.   "
36267|NCT02811042|"     The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic     position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed     anaesthetized pediatric patients.   "
36286|NCT02810795|"     The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection     of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients     with suspected or known CAD clinically referred for invasive angiography.   "
36287|NCT02810782|"     Three different drugs are used in a randomised, double blind, clinical multi-centre trial     with three arms. Major objective is to investigate the duration of drug treatment based on     the Finnegan score. Secondary objectives are to document weight gain, the need for adding a     second drug when the first drug is not effective enough and possible side effects such as     convulsions.   "
36736|NCT02804828|"     The purpose of this study is to develop preliminary evidence, such as effect size and     variance estimates, to guide successful conduct of a properly-powered clinical trial to     assess the benefit of a mitochondrial cocktail plus individualized correction of citric acid     cycle (CAC) intermediates and amino acid (AA) abnormalities as part of a     mitochondrial/oxidative stress treatment approach in Gulf War Illness (GWI).   "
36269|NCT02811016|"     The primary objective of the study is to investigate the effect of inhaled budesonide on the     incidence of AMS. The primary study question to ask is:      1. Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559     m?      In addition, the secondary study questions to ask are:        1. Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559          m?        2. Are the effects of inhaled budesonide on AMS incidence and severity related to its          plasma concentration?      Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg)     versus placebo      Study design        -  Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna          Regina Margherita (Margherita Hut), Italy]        -  With regard to the intervention (inhaled budesonide) double-blinded and randomized   "
36270|NCT02811003|"     To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation     Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of     insertional Achilles tendonitis.   "
36272|NCT02810977|"     Anesthesiologists try to avoid complications with significant peri -operative morbidity and     mortality such as bronchoaspiration in patients requiring a surgical procedure under     anesthesia. Currently, this is achieved based on experts recommendations from the American     Society of Anesthesiologists. However, there are tools like ultrasound that allow assessment     of gastric content and volume. This tool allows to individualize each patient and base the     decisions objectively. The investigators will assess gastric content and volume by ultrasound     in patients who have fasted and require surgery at two University Hospitals.   "
36273|NCT02810964|"     The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a     placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic     medications.   "
36274|NCT02810951|"     The purpose of this study is to evaluate the safety of FCX-007, evaluate C7 expression and     the presence of anchoring fibrils resulting from FCX-007 and to analyze wound healing as a     result of FCX-007 administration in subjects with RDEB.   "
36275|NCT02810938|"     -  Prospective Atrial Flutter Ablation Registry investigating IntellaTip Mifi XP 8 mm          technology and MVG isthmus ablation approach        -  Design: National, multi-centre, prospective observational registry documenting right          atrial isthmus ablation        -  Observational treatment: Combination of MVG ablation strategy and the IntellaTip Mifi XP          8 mm sensor technology        -  Duration: Patients will be followed for 6 months post-ablation   "
36276|NCT02810925|"     The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a     1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients     undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and     following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4).     Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.   "
36321|NCT02810340|"     MCV-5 is a vaccine being studied for use against a germ that causes infections of the brain     and/or the blood. There are several licensed vaccines that protect against meningitis caused     by 4 different types of the germ, but there is one type of the germ that these vaccines do     not protect against. MCV-5 includes the same coverage as these other vaccines and includes a     fifth type. The purpose of this study is to test how this vaccine affects adult human     volunteers when compared to a licensed meningitis vaccine. Investigators will monitor     volunteers for side effects and collect blood to test for antibodies.   "
36277|NCT02810912|"     Gastric regurgitation increases the risk of pulmonary aspiration in surgical patients     receiving general anesthesia because of depression of gastro-esophageal reflux. In addition,     some patients may have higher risk of aspiration as a result of reduced gastric emptying and     gastroesophageal reflux, prolonged surgical time, and laparoscopic surgery. Second-generation     supraglottic airway device (SAD) provides an additional channel to facilitate the drainage     the gastric content to prevent from aspiration, which was routinely used in surgeries.     Currently, multichannel intraluminal impedance-pH (MII-pH) monitoring, which combines     multiple impedance channels to conventional pH catheters, is regarded as the most sensitive     technique for detecting reflux events. Therefore, application of MII-pH monitoring on the     SAD-based general anesthesia may help to detect ongoing reflux/regurgitation in the esophagus     of patients during perioperative period. The hypothesis of the present study is that the     occurrences of gastroesophageal regurgitation during general anesthesia may be influenced by     the several factors, such as abdominal insufflation during laparoscopy, longer surgical time,     Trendelenburg position, higher body weight, etc.   "
36278|NCT02810899|"     The purpose of this randomized, double-blind and placebo-controlled pilot study is to     investigate whether dexmedetomidine when used as an adjuvant to general anesthesia can     decrease the harmful effects of anesthesia and surgery on intelligence development in     pediatric patients undergoing craniotomy.   "
36279|NCT02810886|"     Single arm, phase II exploratory trial to prospectively evaluate the impact of     68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate     cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic     work-up.   "
36280|NCT02810873|"     This clinical trial studies positron emission tomography imaging in using copper Cu 64     TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission     tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help     doctors find and diagnose breast cancer.   "
36288|NCT02810769|"     The first study of my PhD showed that acute supplementation of berry extracts can modulate     cognitive behaviour in healthy adults. There is a growing body of evidence supporting an     improvement in memory and learning performance in animal models following the ingestion of     flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However,     study 2, showed no effect on any aspects of memory in healthy young adults after     supplementation of the berry extracts. It is hypothesised that the lack of behavioural     effects on memory of the berry juice in study 2 was because of the cohort used. These healthy     adult participants were already performing near to their peak (Salthouse et al., 2009), and     unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive     benefits.      The aims of the study are to examine if acute supplementation of two berry extracts in an     older population can augment memory, attention and executive function. Secondly, the time     course of these behavioural effects will be measured by multiple cognitive assessments     throughout the day after consumption of the extracts.   "
36289|NCT02810756|"     The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done     in a patient cohort of n = 12.   "
36290|NCT02810743|"     Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant     phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer     patients) comparing optimized standard-dose chemotherapy with intensified, alkylating     chemotherapy with stem cell rescue.   "
36291|NCT02810730|"     Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is     increasing both in France and in Europe, whereas all the other cancers are decreasing in     Europe. Moreover, its seriousness is still high, with a mortality rate higher than the     average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic     anomalies which can be revealed thanks to imaging, for patients having a 1st degree     pancreatic adenocarcinoma familial history. This could allow detection of lesions which are     less than 10 mm long, and improve the dark prognostic of this pathology.   "
36292|NCT02810717|"     Background:      Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS)     holds promise as an effective treatment for treatment resistant depression (TRD). rTMS has     been linked to neuroplastic changes as shown using magnetic resonance imaging (MRI) and     positron emission tomography (PET). Alterations in serotonin-1A receptor expression (5-HT1A)     have been linked to major depression. Moreover, changes in 5-HT1A receptor binding - observed     after pharmacological treatment, as well as after electroconvulsive therapy - has been linked     to neuronal adaptations in response to these antidepressant treatments.      Objectives of the study:      Here, the aim is to investigate the effects of TBS over left and right dorsolateral     prefrontal cortex on the 5-HT1A receptor binding in patients with TRD using PET. In addition,     effects of iTBS on brain structure and function will be determined using functional,     structural and perfusion MRI.      Study population:      80 patients with TRD who maintain their original medication regimen will be recruited.      Study design:      Longitudinal, randomized and double-blind clinical trial. 40 patients will receive active     TBS, 40 patients will receive sham TBS for treatment duration of three weeks. Before and     after three weeks of treatment, patients will be scanned using MRI and PET with the highly     specific and selective radiotracer [carbonyl-11C]WAY100635. A follow-up visit and final     examination will be performed 2 and 4 weeks after treatment for the active TBS group,     respectively. Patients in the sham TBS arm will receive active TBS treatment immediately     after the second MRI and PET scan.      Relevance and implications of the study:      This will be the worldwide first multimodal imaging study to investigate the effects of TBS     on serotonin-1A receptor binding in TRD using PET. Thus, the study will add crucial knowledge     to the existing literature on the effects of TMS on brain structure and function, related to     antidepressant efficacy. Moreover, by combining molecular imaging of serotonergic     neurotransmission with structural and functional MRI, the proposed study will increase the     investigators knowledge on the serotonergic role in shaping brain morphology, microstructure     and structural/functional connectivity. Taken together, the study has the potential to     contribute to the development of personalized treatment, the reduction of personal suffering     and the reduction of costs and occupational disability.   "
36293|NCT02810704|"     PEPPER is a randomized study comparing the three most commonly used anticoagulants in North     America in patients who have elected to undergo primary or revision hip or knee joint     replacement surgery. The anticoagulants being compared are enteric coated aspirin, low     intensity warfarin, and rivaroxaban.   "
36322|NCT02810327|"     The goal of this study is to better understand why some Alpha-1 genotype MZ (PiMZ)     individuals develop chronic obstructive pulmonary disease (COPD) while others do not. This     study will examine portions of the Alpha-1 gene that are not routinely tested to determine     whether other changes in this gene correlate with development and progression of COPD.     Participation involves responding to questionnaires about lung health and history, and     performing an at-home finger stick to obtain blood spots using a test kit that is mailed. The     blood provided will be used for genetic testing and correlation of results with COPD history.     Participants will receive their results and access to genetic counseling at the conclusion of     the study.   "
41011|NCT02748824|"     To assess the five-year incidence of AMD in a population from the central region of Portugal,     previously phenotypically characterized.   "
36294|NCT02810691|"     With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi     systemic disease, continue to evolve. A major emerging complication is CF related diabetes     (CFRD) which is occurring in 40-50% of adults. Patients who develop CFRD are at increase risk     of morbidity and mortality and they are also facing an increased medical burden with insulin     therapy, the only recommended treatment. Accelerated decline in weight and/or pulmonary     function start 2 to 4 years before CFRD onset and this period is characterized by frequent     Post-Prandial Glycemic (PPG) excursions. Higher PPG excursions are associated with lower     pulmonary function and it predicts future CFRD risk. To the improved nutritional status, lung     function and survival of patients, the nutritional approach for patients with CF focuses on     high-energy high-fat diet and a pancreatic enzyme supplementation. However, such diet also     contributes to increased PPG excursions. Based on the beneficial effects of nutrition therapy     to improve PPG in other forms of pre-diabetes and diabetes, extending such benefits to     patients with CF is important. The investigators aim to test the feasibility and the     effectiveness of a viscous fiber supplement to reduce PPG in adult patients with CF. Using a     randomized crossover design, the investigators will study the impact of two doses of a     viscous fiber supplement as compared to a placebo.   "
36295|NCT02810678|"     The study is a pragmatic cluster randomized trial that is being conducted in 6 countries,     with sites in 4 cities in Canada, Benin, Brazil, Ghana, Indonesia and Vietnam. The trial     tests a complex intervention-a two phase programmatic public health package which includes a     standardized public health evaluation and analysis, to identify problems and barriers     limiting Latent Tuberculosis Infection diagnosis and treatment among close contacts of active     Tuberculosis cases. This will be followed by implementation of appropriate solutions. The     primary objective of the study is to increase the proportion starting Latent Tuberculosis     Infection treatment among household contacts of patients with active pulmonary. A secondary     objective is to evaluate the cost effectiveness of this two phase intervention. If     successful, this approach can be expanded throughout these countries. After initial     preparations, including administrative and ethical review, all participating sites will be     randomized to intervention or control. Immediately after this, Phase 1 will begin in     intervention sties with the standardized public health evaluation to identify barriers to     LTBI diagnosis and treatment initiation and the selection of solutions to be used in Phase 2.     To ensure standardization of data gathering research staff will use (i) current indicators of     the Latent Tuberculosis Infection cascade of care in intervention facilities (number of     contacts per index case registered, investigated, started on treatment and completing     treatment) and (ii) interviewer administered questionnaires for patients with active     pulmonary Tuberculosis, adult and child household contacts and clinic staff. These     questionnaires will assess latent Tuberculosis-related knowledge, attitudes and beliefs from     the perspective of these different participants. Results from intervention sites in Phase 1     will be analyzed, and used by the investigators, together with local public health officials,     to decide on appropriate corrective solutions in each sites. In Phase 2, solutions for     problems identified will be selected and implemented at the intervention sites. Study     outcomes and costs will be measured at all intervention and control sites throughout Phase 1     & 2. Results will be disseminated within each country through existing links with national     Tuberculosis programs, and through international organizations such as the World Health     Organization.   "
36296|NCT02810665|"     This is a cross-sectional study to determine the repeatability and concordance of visual     acuity level measured with the original ETDRS letter, ETDRS Landolt C, and ETDRS numeric     chart in Thai individuals.   "
36300|NCT02810613|"     (Bio)medical research, particularly immunological, metabolic, transcriptional or biological     assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine.     In order to comply with international guidelines for Good Clinical Practice, the     investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or     urine from voluntary donors. Recruitment of volunteers will be a continuous process.     Volunteers will consent to occasional blood- or urine donation.   "
36301|NCT02810600|"     Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE     injection in patients with suspected or diagnosed with tumors expressing somatostatin     receptors. Each included patient will receive an administered dose of 50 mcg or less of the     peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE.      The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous     studies.   "
36302|NCT02810587|"     This is a prospective case series which aims to determine the incidence of endophthalmitis     following intravitreous anti-vascular endothelial growth factor (VEGF) injection comparing     between eyes receiving post-injection antibiotics drops and those not receiving antibiotics     drops treated at Chiang Mai University Hospital between May 2015 and April 2017 (2-year     period).   "
36303|NCT02810574|"     The purpose of this study is to determine whether combining noninvasive brain stimulation     with cognitive training can reduce craving in adults with tobacco use disorder.   "
36304|NCT02810561|"     The goal of this study is twofold. First the investigators would like to determine the     trajectory of troponin leaks; if it can be shown that the participants who have only minimal     elevations of their repeat troponin universally decrease on the 3rd level then future     patients may see significantly improved length of stay. Second, given conflicting results in     the literature, the investigators would like to determine if elevated troponin levels     correlate to later cardiovascular complications. These complications will be defined as     Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting     or bypass). As the investigator is a single hospital system in this county it is uniquely     positioned to be able to review this retrospectively.   "
36305|NCT02810548|"     Background: the ultimate goal of periodontal therapy is the regeneration of periodontal     tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in     osseous regeneration in the areas of periodontal surgery.      Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in     periodontal intrabony defects.   "
36306|NCT02810535|"     The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not     selected group of young students (n=100-300). Students will be selected by public posting. In     all students an allergy skin test will be performed. Then the local IgE of 24 subjects with     non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic rhinitis     and positive prick test to house dust mite. In addition 20 controlls will be investigated.     Based on these investigations, the importance of local IgE and the IgE spectrum in     conjunction with rhinitis should be further clarified.   "
36323|NCT02810314|"     The study will evaluate connectivity regardless whether patients present a clinical type that     requires medical treatment. In this point, investigators will include patients with     progressive evolution as well as initial forms of the disease (CIS) and properly established     forms of multiple sclerosis (MS) in remittent-recidivant (RR) forms. The researches will not     focus on medical treatment as some of these clinical forms have no indication for disease     modifying drugs.   "
36324|NCT02810301|"     Study to demonstrate the efficacy of Probiotic ES1 in alleviating symptoms of gluten     sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of     gluten.   "
36307|NCT02810522|"     This study is to support the regulatory application of OneTouch Select® Plus test strips in     China. The blood glucose test strip is regulated as an In Vitro Diagnostic (IVD) product and     China Food and Drug Administration (CFDA) regulation of IVDs should be complied with. The     result of this study will be used to support regulatory filing in China.      Investigational Product:      OneTouch Select® Plus test strips (test with OneTouch Select® Plus glucose meter)      Objectives:        1. Assess Lay User and Health Care Professional (HCP) fingertip test results obtained on          OneTouch Select® Plus BGMS compared to a validated method (YSI 2300 glucose analyzer          results), according to International Standards Organization( ISO) 15197:2003(E) section          8.0 and ISO 15197:2013(E)        2. Lay User System Use evaluation.        3. Assess the effectiveness of the instructions for use of OneTouch Select® Plus BGMS          (Owner's booklet) and insert of test strips for the lay user.      Comparator(control) Product:      YSI 2300 glucose analyser      Acceptance Criteria:      User Performance of the OneTouch Select® Plus Blood Glucose Monitoring system(described as     OneTouch Select Plus below) is met if the lay user and HCP results obtained with OneTouch     Select Plus meet the requirement stated in section 7.4.1 of ISO () 15197:2003(E). Further to     meet the requirements of ISO 15197:2013(E) , the lay user results obtained with OneTouch     Select Plus should meet the requirements stated in section 8.2 of ISO 15197:2013(E). The     effectiveness of instructions for use is met , if for each item on the Instructions for Use     Questionnaire, the 90% lower confidence limit (90% LCL) for the correct response rate is     equal to or greater than 70%.      Study Design and subject population:      This study is an open, non-randomized clinical evaluation and will be conducted at a minimum     of 2 sites in China. At least 240 evaluable diabetic subjects who meet the enrolment criteria     will participate in this evaluation.      Study procedures:        1. Each potential Subject (or legally authorized representative) reads and signs the          Informed Consent Form, and receives a signed copy.        2. After completing an in-clinic familiarization session, the Subject lances a fingertip,          obtains a drop of blood large enough for two meter tests, and performs a self-test using          OneTouch Select Plus BGMS.        3. Study staff immediately performs a blood glucose test from the same blood drop with a          second set of OneTouch Select Plus BGMS with the same lot of test strips.        4. Within 5 minutes of the Subject's self-lancing, study staff collects blood from the same          finger puncture for hematocrit and reference plasma glucose testing (duplicate tests on          the YSI 2300 performed by study staff).   "
36308|NCT02810509|"     The current study aims to assess the quality of anticoagulation with warfarin in real world     practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and     to explore predictors for poor International Normalized Range (INR) control.   "
36309|NCT02810496|"     As the investigators observed a case of glucocorticoid mutation revealed by incidentally     discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular     anormality could be more frequent than previously described. To validate this hypothesis, it     was decided to study 150 multicenter consecutive patients, presenting with incidentally     discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all these     patients GR gene will be studied, mutations will be detected and described, functional     disturbance will be tested. Usual polymorphisms will be described. Correlation between     clinical signs, hormonal and morphological abnormalities and presence or absence of GR     mutations will be searched.   "
36327|NCT02810262|"     Mortality due to non small cell lung cancers is the first cause of cancer death in men around     the world. Lung adenocarcinoma regularly induces bone metastases responsible for high     morbidity and impaired life quality. Overall survival of these patients is poor. Thus the     investigators aimed to identify if some bone and metabolic parameters were associated with     overall survival.      Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma     lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with     molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis     localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is     obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of     bone and metabolic biomarkers.      Survival analyses will be performed using a proportional hazard regression model.   "
48449|NCT02651454|"     The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and     Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors   "
36310|NCT02810483|"     There is no specific treatment for core symptoms of PWS. Regarding behavioral and psychiatric     symptoms (hyperphagia, imulsivity and self-mutilations), one of the only drug options     consists in antipsychotics, that are not efficient and might be responsible for a worsening     of the weight gain (major issue in PWS). An alternative therapeutic approach for behavioral     disturbances has been suggested by some authors with topiramate (Epitomax®), an antiepileptic     drug that can be used as a mood stabilizer and anti-impulsive. In addition, topiramate is     used as a treatment for eating disorders because it induces loss of weight and appetite. This     last effect might be useful in the case of SPW.      Except for some clinical case reports, the investigators only found one open study for     topiramate in SPW 8 patientssuggesting promising effects. There si however no placebo     controlled study..      Objective:      To evaluate the efficacy of topiramate (200 mg / d) on Eating disorders (E), self Mutilations     (M), irritability and Impulsivity (I), metabolic status, and tolerance among of PWS patients.      Methodology:      This is a multicenter (out-patients in Toulouse, Reims, Nantes and Paris and in-patients in     Hendaye) 8 weeks double-blind placebo controlled study .      Subjects (n = 125 for 112 analyzable) all having PWS, aged 12 years-old and more should have     any of the following symptoms: E, M and U (see above). All subjects will be randomly     allocated into two groups one taking a placebo, the other taking topiramate (50mg / day     initially, increasing up to 50mg per week 200mg / day).      The population of analyzable patients in and out patient will be of equal size (n = 56). The     inclusion period is two years..      Are excluded subjects with antipsychotic or mood stabilizer medication or topiramate.      The primary endpoint will be the rate of responders, with response defined by obtaining a     score of 1 or 2 on the CGI improvement after 8 weeks of treatment      Other assessments, secondary endpoints :        -  Clinic: Weight / Size / Self-injury behavior (french Echelle des Conduites Auto et          Hétéro Aggressives, ECAHA))        -  Psychometric: C-SHARP and A-SHARP / Conners (Impulsivity) / Dickens (Eating behavior for          PWS)        -  Organic: NFS, serum electrolytes, creatinine, ammonia plasma, serum bicarbonate, AST /          ALT / GGT, ghrelin, fasting glucose, lipid profile and insulin, leptin, TG and HbA1c.        -  Side effects of topiramate: SAPS / SANS and BPRS (hallucinations), anxiety scales and          laboratory tests.   "
36311|NCT02810470|"     Malnutrition is a major health problem with serious consequences for the quality of life of     elderly people: it increases the number of hospitalizations and lengths of stay, worsens     functional dependency and increases morbidity and mortality rates There are numerous     recommendations and tools to detect or to manage malnutrition and the prescription of Oral     Nutritional Supplements (ONS) can be a solution. As the elderly suffer from food monotony, as     well as age-related changes, which may or may not be associated with the presence of disease,     it is necessary to ensure full ingestion of the prescribed supplements to optimize the     benefits provided by these products. To achieve this it is necessary to know the chemosensory     characteristics of foods enjoyed by hospitalized elderly people who are malnourished or at     risk of malnutrition. The investigators make the hypothesis that by further optimizing taste     and energy content of foods, consumption by the elderly and the health benefits would be     improved.   "
36312|NCT02810457|"     The purpose of this research study is to compare the effectiveness and safety of FKB238     against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung     cancer   "
36313|NCT02810444|"     This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in     treating patients with Primary Immunodeficiency (PID)   "
36354|NCT02809898|"     Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of     biliary tract cancer.   "
36314|NCT02810431|"     Background:      This protocol is designed to have samples from closing protocols transferred to this protocol     for long-term storage. The protocol is concerned with the retention of blood, plasma, serum,     CSF, aspirates, bone marrow, ascites fluid, urine, saliva, PBMCs, skin, mucosal, tumor and     healthy tissue samples from patients with cancer to support basic science and clinical     research activities of the Medical Oncology Branch and other intramural Laboratories and     Branches at the NIH Clinical Research Center and Center for Cancer Research.      Objectives:      To allow long-term storage of biospecimens collected during prospective clinical trials in     patients with various cancer phenotypes, as needed to support the research activities of the     Medical Oncology Branch and other Laboratories and Branches.      Eligibility:      Samples eligible for long-term retention must be from those who have signed consent for     storage and retention of biospecimens.      Design:      Acquired samples will be barcoded and associated data will be entered into an encrypted     computer software system, and securely maintained to protect patient identifiers. Samples are     retained and made available to the original PI, or other Investigators with the original PI's     permission, following submission and approval of a supplemental research protocol to the IRB     or OHSRP.   "
36315|NCT02810418|"     Background:      LMB-100 is a man-made protein designed to kill cancer cells. LMB-100 targets a cancer marker     called mesothelin. Mesothelin is found on the surface of many different tumors, including     pancreatic cancer, but is made by a very small number of normal tissues. Other cancers that     make mesothelin include mesothelioma, cholangiocarcinoma, thymic carcinoma, ovarian, lung,     gastric, endometrial, cervical, and ampullary cancers. After binding to the mesothelin on     tumors, LMB-100 can attack and kill cancer cells. Researchers want to see how well it works     when given with and without nab-paclitaxel, a drug which treats pancreatic cancer.      Objectives:      Arm A- To find a safe dose of LMB-100 with a fixed standard dose of nab-paclitaxel in people     with advanced pancreatic cancer. To see how well the combination of the two drugs reduce     tumor size.      Arm B- To find a safe dose of LMB-100 when it is given as a continuous infusion over several     days.      Eligibility:      Arm A- Adults age 18 and older with advanced pancreatic cancer that has worsened after     anti-cancer therapy.      Arm B- Adults age 18 and older with advanced pancreatic cancer, mesothelioma or other solid     tumor that makes mesothelin that has worsened after anti-cancer therapy      Design:      Participants will be screened with medical history and physical exam. They will give blood,     urine, and tissue samples. They will have scans and x-rays.      During each 21-day cycle:        -  For Arm A             -  Participants will get LMB-100 by an IV catheter on days 1, 3, and 5. This is a tube               inserted in a vein, usually in the arm.             -  Participants will get nab-paclitaxel by IV on days 1 and 8.        -  For Arm B             -  Participants will get LMB-100 by an IV catheter as a continuous infusion beginning               on day 1 and continuing for 2-4 days             -  Some participants will also get nab-paclitaxel by IV on days 1 and 8.      All participants will get this combination for up to 2 cycles or until their disease worsens     or they have intolerable side effects.      Participants will have blood and urine tests and scans throughout the study.      Participants will have a safety follow-up visit 3-6 weeks after treatment ends. If their     disease remains stable or improves, they will be scanned every 6 weeks until their disease     gets worse. Even if their disease gets worse, they or their doctor will be called to talk     about their cancer status....   "
36316|NCT02810405|"     BACKGROUND:      Cancer of any type is a serious disease and despite all the progress made from past research,     there is still much that is poorly understood at the molecular level. Recent advances in     biomedical technology platforms have emerged as critical tools for accelerating personalized     medicine. The collection of human tissue specimens has been an invaluable resource for     conducting translational cancer research using these developing technologies. The ultimate     goal is to understand the molecular indicators of cancer development and progression. While     it is ideal to be able to study clinical samples, specifically tissue biopsies, they are     however precious and are often difficult to obtain in sufficient quantities or numbers to     conduct proteomic or molecular profiling studies. There exists, however, a vast archive of     pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded     tissue blocks. The preservation of these tissue blocks and/or slides for long-term (years)     storage is an important asset that aids in translational and clinical research. This protocol     will describe the procedures for receiving, labeling and storing paraffin-embedded tissue     blocks and/or slides until they are needed for future analysis. When blocks are ready for     analysis, the requestor will then follow the IRB protocol specific to that study.      OBJECTIVE:      - To obtain tissue blocks and slides from outside pathology departments for cancer patients     being treated at the Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research     (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis     (e.g., using molecular technology platforms).      ELIGIBILITY:      - Patients suspected of having, or with biopsy proof of malignant disease will be evaluated     in the Medical Oncology Branch and Affiliates Clinics, NCI.      DESIGN:        -  Tissue blocks and slides will be acquired from outside pathology departments and          received by the Clinical Pharmacology Program of the MOB/CCR/NCI for coding.        -  Bar-coded tissue blocks and slides will then be transferred to the Laboratory of          Pathology/CCR/NCI for proper long-term storage.   "
36317|NCT02810392|"     Almost two-thirds of survivors have cognitive impairment (CI), manifested as memory,     language, and judgement problems. Post-stroke CI at 2 weeks is a significant predictor of     long-term functional outcome, and more generally, cognitive impairments have a major impact     on functional outcome and ability to participate in rehabilitation. CI is associated with     increased systemic inflammation. Intranasally-administered insulin is a promising new therapy     for enhancing memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease     (AD), shown in multiple randomized controlled studies. Likely mechanisms of benefit are     intranasal insulin's ability to restore normal cerebral insulin signaling. Based on the     overlap in cerebral insulin resistance that occurs in both AD and post-stroke CI, we have     designed an innovative proof-of-concept, feasibility trial designed to provide pilot data as     to whether post-stroke survivor CI and caregiver burden is improved with intranasal insulin     early after stroke. We will explore the impact of intranasal insulin on inflammatory     biomarkers, since inflammation is a major underlying cause of CI, as shown by others and in     our preliminary studies of VCAM-1. Specific Aims are: 1. Determine if patients with ischemic     stroke randomized to intranasal insulin 20 IU BID for 3 weeks have improved cognition,     compared to patients who receive intranasal saline. Primary outcome is a composite of (a)     memory and executive function z scores. 2. To assess the impact of intranasal insulin vs     saline on change in inflammatory biomarker levels (VCAM-1, TNF-alpha, TNFR-I and II) before     and after the treatment period. 3. To measure differences in burden among caregivers of     participants in the intranasal insulin vs intranasal saline groups. We will prospectively     randomize 40 subjects to intranasal insulin (40 IU) vs saline treatment. Following baseline     cognitive testing 2 weeks post stroke, subjects will receive the assigned treatment for 3     weeks, followed by a 3-week washout period, with cognitive testing performed after the     treatment and washout periods and again at 20 weeks. The proposed study will provide data on     a promising method for treating cognitive function in stroke patients. If effective, our     pilot data will set the stage for larger phase III clinical trials.   "
36318|NCT02810379|"     To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with     written informed consent provides participants more information about the procedure, which     can make participants understand the procedure well. Investigators advocate the development     of institutional and national guidelines to ensure optimal practices of acquiring informed     consent.   "
36319|NCT02810366|"     The objective of this study is to compare the performance of computer-coded verbal autopsies     (CCVA) to physician-coded verbal autopsies (PCVA) at the population level. In order to do so     a randomised control trial is being conducted in five districts of India. In each district,     50% of deaths are randomly selected for PCVA and the rest for CCVA. The cause of death     distribution for both groups are then compared within each district. If the performance of     PCVA and CCVA are comparable, the attained distributions should be similar.   "
36320|NCT02810353|"     This study evaluates the dentoskeletal effects of the expander with differential opening in     orthodontic patients in the mixed dentition. Half of participants will undergo rapid     maxillary expansion (RME) using the expander with differential opening, while the other half     will undergo RME using the conventional Hyrax expander.   "
36372|NCT02809781|"     The purpose of this study is to evaluate the safety and clinical effect of mesenchymal stem     cells (MSCs) derived from human bone marrow at a dose of 1.0E+6 MSC/kg in subject for the     therapy of Ankylosing spondylitis (AS) and to compare the efficacy of MSCs and Etanercept to     treat this disease.   "
36325|NCT02810288|"     Respiratory adverse events continue to be the leading reason for perioperative critical     events in children. It is crucial for the anaesthesiologist to anticipate, recognize and     treat these respiratory adverse events. Respiratory adverse events are one of the major     causes of morbidity and mortality during paediatric anaesthesia. To avoid trouble, one must     be prepared for trouble: if a difficult airway is very likely, anaesthesia should be     administered by experienced anaesthesiologists and should only be performed in a protected     well-equipped area where the personnel adequately trained.      This survey focuses on assessment and management of paediatric airway and highlights the     unique challenges encountered in children.   "
36326|NCT02810275|"     Patients infected by HIV or HIV-HCV coinfected have higher survival due to the use of HAART,     but survival is accompanied by increased morbidity and associated cardiovascular disease     (CVD). Endothelial dysfunction is an early marker of atherogenesis, acting as an intermediate     in the causal pathway of CVD. Folinic acid (FA) has been shown to reduce CVD outcomes,     especially among individuals with hyperhomocisteinemia.      To date, few studies provided consistent information about efficacy of pharmacological     interventions that minimize damage to the vascular endothelium in patients infected by HIV or     HIV-HCV coinfected. The main hypothesis of this study is that FA supplementation protects the     vascular endothelium, and consequently might prevent subclinical atherosclerosis. Thus, the     first step is to determine the efficacy of supplementation with FA, and to compare the effect     between HIV and HIV-HCV coinfected.   "
36334|NCT02810171|"     Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in     childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life     anxiety, but as many as 40% of young patients who receive CBT fail to get better. The     proposed study will examine brain changes marking positive response to CBT for anxiety and     how these changes may differ in children compared adolescents. By helping us to understand     how CBT works, this study will pave the way for new treatments to stop anxiety early.   "
36328|NCT02810249|"     HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has     been approved by the FDA as a method for reducing HIV transmission rates in the population,     particularly young men who have sex with men (YMSM). This study will use a qualitative design     to interview 20-30, HIV-negative, 16-24 year old African American YMSM to: 1) identify and     understand African American YMSM's, aged 16-24, cognitive and emotional processes in response     to using PrEP to reduce their risk for HIV and 2) identify what factors (sociocultural,     individual, experiences in health care, socioeconomic) influence African American YMSM's     likely use of PrEP as a coping strategy for HIV prevention. Demographic information will be     collected and analyzed using Statistical Analysis Software version 9.3. Individual interviews     will be audio recorded and transcribed by a vetted transcription service for analysis. This     is minimal risk to participants.   "
36329|NCT02810236|"     The investigator hypothesizes that a benign directed ultrasound, when performed after a     normal digital mammogram, will provide women with focal breast pain additional reassurance     that the etiology of their symptom is benign. 160 women over the age of thirty with focal     breast pain who present to the Breast Imaging Clinic for evaluation between 3/1/2016 -     7/1/2018 will be selected and randomized to three groups using a block randomization     technique. All study participants will complete a survey assessing psychosocial factors, then     receive a digital mammogram. Patients with a negative mammogram will continue on with the     study and will either have a conversation about their negative mammogram with a radiologist     or receive a directed ultrasound. A second survey will be conducted assessing psychosocial     factors. All study participants who did not receive an ultrasound will receive an ultrasound     so that all study participants are provided with the standard of care for focal breast pain.     The results of the survey will be compared and appropriate statistical analyses such as an     Analysis of Variance (ANOVA) test will be conducted to determine any statistically     significant differences between the three randomized groups. The risks/safety issues of this     study are believed to be minimal.   "
36330|NCT02810223|"     This is a single arm, open-label, multi-center study to determine the efficacy and safety of     an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell     ALL.   "
36331|NCT02810210|"     The Zika epidemic has spread into the three French Overseas Departments in the Caribbean     (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for     the evaluation of potential complications due to having ZIKV infection during pregnancy.      This study is meant to collect, within usual care practices, clinical and paraclinical     information (including imaging and laboratory results) as well as biological samples allowing     the precise description of the consequences of ZIKV infection during pregnancy.      This study is the 2nd arm of a global research program in the 3 French Overseas Departments     in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the     follow-up of women in the French Overseas Departments who are pregnant during the Zika     epidemic period.      The study population is made up of infants born during and up to 9 months after the end of     the Zika epidemic period in the French Overseas Departments.      The data and biological specimens collected for this project will be done so through the     recommended standard of care which has been put in place considering the ZIKV epidemic in the     3 French Overseas Departments, upholding existing recommendations (profession and/or     recommendation from the public health authorities)   "
36332|NCT02810197|"     This is a multiwave longitudinal neuroimaging study in a cohort of direct survivors of 11/13     Paris terrorist attacks. Both structural and functional brain imaging data will be collected     at 8-12 months, 3 years, and 6 years after trauma in exposed participants as well as in     control non-exposed participants. This project will capitalize on recent evidence showing     that healthy participants can prevent unwanted images from entering consciousness using     inhibitory control and memory suppression techniques, disrupting traces of the memories in     sensory areas of the brain, and weakening their vividness and later reentrance. This process     is believed to be affected in Post-traumatic stress disorder (PTSD) which is characterized by     anxiety and persistent intrusive memory of the traumatic event with highly distressing     contents. This project will thus provide a unique opportunity to observe the online and     structural dysfunctions of intrusion control network following a severe psychological trauma     and how such process may contribute to recovery and psychopathological dynamics. In addition,     the disruption of social cognition and emotional processing following PTSD will also be     investigated in relation to disrupted inhibitory control functioning.   "
36333|NCT02810184|"     Background      Bone augmentation provides a solution for patients with a severely atrophic jaw to achieve     immediate fixed prosthetic rehabilitation. Studies reporting total bone volume changes are     lacking.      Objectives      The investigators aim to determine the level of total bone volume remodeling at 6, 24 and 36     months post-surgery in patients who underwent immediate prosthetic rehabilitation through a     cranial bone-grafted maxilla in combination with immediate provisional implant (IPI)     placement.      Study design      A prospective, longitudinal study.      All patients will be recruited at time of pre-surgical consultation.      During the surgical procedure, autogenous cranial graft reconstruction of the jaw is carried     out under general anaesthesia.      Cone-beam CT (CBCT) scans (NewTom VGi evo, QR Verona, Italy) will be taken pre-operatively,     and at different time-points post-operatively to evaluate the remodeling process of the bone     after the grafting procedure with implant placements and assess the total bone volume changes     up to 3 years post-surgically.      CBCT scans will be send to the oral maxillofacial surgery (OMFS) Research Group within the     Department of Imaging and Pathology (IMPATH), Catholic University Leuven (liaised with the     clinical department of Oral and Maxillofacial Surgery; University Hospital Leuven) for     analysis of the total bone volume.      Data related to patient demographics, clinical diagnosis, the surgical procedure, IPI     stability, and total bone volume at different time-points will be registered by a clinical     research coordinator.      Conclusion      This prospective trial could add important knowledge to the field, and provide indications to     improve future clinical pre-prosthetic management.   "
36335|NCT02810158|"     To answer the question whether a previously detected breath profile in patients suffering     from obstructive sleep apnoea (OSA) can be found in a cohort of patients with suspected OSA     using mass spectrometry (validation study).   "
48450|NCT02651441|"     The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined     with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer     (NSCLC).   "
36336|NCT02810145|"     We will determine the incidence and magnitude of cerebral desaturation in TBI. Adult patients     (18 years and older) admitted to the Surgical/Trauma Intensive Care Unit (ICU) at the Health     Sciences Center with a severe TBI will have cerebral oximetry monitoring instituted within 12     hours of admission and continuing for 72 hours after placement. Decreases in regional     cerebral oxygenation will be correlated with ICU hemodynamic parameters including mean     arterial pressure, intracranial pressure, and arterial oxygen and carbon dioxide tension.   "
36337|NCT02810132|"     The study evaluates the effects of metformin treatment on myocardial efficiency in heart     failure patients. 36 patients will be randomized to three months of metformin or placebo     treatment in addition to their regular therapy.      Hypothesis: Treatment with metformin in patients with heart failure has direct or indirect     beneficial effects on left ventricular myocardial oxidative metabolism, myocardial efficiency     and contractile function.   "
36338|NCT02810119|"     A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and     Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis   "
36339|NCT02810106|"     Cardiovascular diseases are important cause of death, and of these have highlighted the     Coronary Artery Disease (CAD) and its various clinical manifestations. The chest pain     suggestive of ischemic heart disease is frequent complaint in medical consultations and     hospitalizations . Complementary tests and images exams for risk stratification as Cardiac     Stress Test (ET), the Myocardial Perfusion scintigraphy of (SPECT) are established for risk     stratification and assessment workup in suspected ischemic heart disease. Coronary tomography     angiography (CTA) has emerged as a robust method for non-invasive assessment of CAD, showing     data diagnostics that directly correlate with invasive coronary angiography. Recently, the     Myocardial Perfusion by Tomography Computed (CTP) has emerged as a new technique to measure     the flow limitation for coronary microcirculation. In clinical practice, the exercise testing     with electrocardiogram changes compatible with myocardial ischemia can lead to other     examinations for elucidation of ischemic etiology, the most usual myocardial scintigraphy.     However, a SPECT without evidence of ischemia, does not explain ischemic electrocardiographic     changes triggered by physical stress, although it is a good marker prognostic. A CTP is a     emerging tool in the evaluation of myocardial ischemia. Recent studies point to a good     accuracy of the method compared to nuclear medicine. To test this hypothesis, this study aims     to evaluate whether the CTP has a better diagnostic performance in detecting of obstructive     or not obstructive CAD compared to the SPECT in the population of patients with exercise     stress testing compatible with myocardial ischemia, and the computed tomography angiography     (CTA) as the reference method. In addition, data from the exercise test (functional capacity,     hemodynamics, electrocardiogram changes) will be compared to findings of CTA and CTP.   "
36340|NCT02810093|"     Primary purpose :      To develop a method to automatically extract and structure the information included in     numerous medical records from breast cancer patients.      Secondary purpose :      With this procedure we can analyze the content of ten thousand anonymized textual medical     records.      This information should enable us to explore many subjects, such as:        -  The impact of certain therapeutic procedures        -  The characteristics of sub-groups of patients        -  Pregnancy associated breast cancers        -  Risk factors   "
36341|NCT02810067|"     Root coverage with acellular dermal matrix using the coronally positioned tunnel technique     comparing two different donor materials   "
36342|NCT02810054|"     After performing the power calculation, healthy adult participants for the study will be     randomly allocated into two groups. The intervention group will receive minimally invasive     surgical techniques (MIST) with enamel matrix derivative (Emdogain) as a treatment of     intrabony periodontal defect. The control group will receive minimally invasive surgical     techniques (MIST) without enamel matrix derivative (Emdogain).      Clinical attachment level (CAL) gain and periodontal pocket depth (PPD) reduction as well as     the position of gingival margin (REC) as the main outcomes and the radiographic intrabony     infill, bleeding on probing (BoP), full mouth plaque score (FMPS) and full mouth bleeding     score (FMBS) as secondary outcome will be recorded for the participants by 3 examiners at     three stages:        1. Before the procedure as a baseline record.        2. 6 months after surgery, all parameters EXCEPT intra oral periapical (PA) radiographs.        3. 12 months after surgery.      The readings will be recorded using The University of Michigan O Probe with William's     Calibration OR Pressure Sensitive Periodontal Probe at 0.3 N to the nearest millimeter for     the clinical attachment level gain (CAL), the periodontal pocket depth (PPD) and the position     of gingival margin (REC), present or absent for the bleeding on probing (BoP), and intra oral     periapical (PA) radiograph for crestal bone level assessment.   "
36373|NCT02809768|"     The purpose of this study is to determine the effects of concomitant administration with     fluconazole, itraconazole, and rifampin on the pharmacokinetics (PK) of a single 20-mg dose     of avatrombopag in healthy participants.   "
36343|NCT02810041|"     Overweight and obesity are public health problems worldwide. Even though heredity may be one     of the causes the diseases, the vast majority of cases is rather linked to a sedentary     lifestyle associated or not with a low-variety, high-calorie diet. Many diets and slimming     methods propose low-calorie meals or physical exercise, and the consequences of these are     sometimes negative with advancing age (muscle wasting). Certain studies have shown the     efficacy of foods with antioxidant properties on the reduction of blood pressure, Low Density     Lipoprotein (LDL)-cholesterol and weight or on the distribution of fat mass-lean mass. The     investigators put forward the hypothesis that the daily consumption of two yoghurts     containing XXS, a mixture of natural polyphenolic compounds -rich in quercetin- from plant     extracts, could lead to weight loss, a better fat mass-lean mass distribution and an     improvement in markers of oxidative stress in overweight persons aged 50 to 65 years.   "
36344|NCT02810028|"     In adults, muscle diseases are usually chronic long-term conditions that do not have a     definitive cure. Supportive care has been shown to reduce complications from muscle disease     and improved survival in some cases. However, there has been limited research to evaluate     interventions that may improve quality of life (QoL) with this patient group. The QoL of     those with MD is not just affected by the severity of their MD but also a variety of     psychological variables. Based upon the knowledge of these psychological variables the     investigators feel that a particular type of psychological intervention known as acceptance     and commitment therapy (ACT) could potentially improve QoL in those with MD. The     investigators therefore propose to test whether ACT does in fact improve QoL in those with MD     by randomising 154 patients to receive either standard medical care plus a guided self-help     ACT programme, or standard medical care only.   "
36360|NCT02808767|"     This study evaluates the efficacy of Prasugrel and Ticagrelor in the treatment of acute     myocardial infarction.   "
36361|NCT02808754|"     This is a randomized controlled trial designed to test an intervention (Remote ischemic     preconditioning) in patients undergoing carotid endarterectomy (CEA) for carotid artery     stenosis (CAS). The outcomes of interest include neurocognitive function, cardiac     complications, and biomarkers of brain ischemia.   "
36362|NCT02808741|"     Single dose comparison of liquid and solid formulation, followed by study of effect of high     fat breakfast.      Evaluation of multiple dose pharmacokinetics and tolerability   "
36345|NCT02810015|"     Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular     joint (TMJ), masticatory muscles and associated structures. This broad complex of functional     disorders often affects the face and jaws causing chronic pain, earaches, headaches,     migraines, neck pain, and dysfunction in many people. Patients that do not find benefit with     conservative management require surgical intervention. Recently, the use of botulinum toxin     has proven effective and has the potential to bridge the gap between conservative therapy and     surgical management resulting in less patients requiring invasive surgery. Objective: We aim     to treat TMD of muscular origin using Botulinum toxin injections in the trigger points.     Methods: Patients, whose pain originates from trigger points, will be enrolled in this     prospective trial. This study will evaluate subjective and objective responses to treatment     with botulinum toxin. The pair of masticatory muscles, masseter and temporalis, will be     injected with 30 units and 20 units of botulinum toxin, respectively. Subjective outcomes     such as pain and orofacial function on a visual analog scale as well as objective outcomes     such as maximal interincisal mouth opening, tenderness to palpation to the temporalis and     masseter muscles, maximal bite force measured by electromyogram and the reduction in muscle     bulk due to muscle disuse atrophy will be assessed. Expected Results: We expect trigger     points in these patients to disappear and the associated muscles to become partially     paralyzed and relaxed. Consequently, we expect that the TMJ loading will be reduced and that     the patient's overall functional ability will increase. We also expect that muscular     hypertrophy volume from hyperactivity will decrease due to disuse atrophy and impact their     cosmetic image positively. Overall, we hope these changes will result in a reduction in pain     and headaches which will consequently improve the participant's diet, nutrition,     psychological well being and quality of life.   "
36346|NCT02810002|"     One hundred infantry recruits will be randomly assigned to two groups. Injuries will be     monitored.   "
36347|NCT02809989|"     The aim of this non-interventional study is to extend the knowledge on effectiveness of     Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a     Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.   "
36348|NCT02809976|"     The purpose of this study is to determine if topical ruxolitinib 1.5% will provide     repigmentation in vitiligo lesions.   "
36349|NCT02809963|"     The aim of this study is to investigate the effect of selective blocking of the     mineralocorticoid receptor in patients with type 2 diabetes on insulin resistance, lipid     metabolism and myocardial function.   "
36350|NCT02809950|"     Many patients receiving opioid based analgesia after spinal surgery experience postoperative     nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents.     Dehydration caused by fasting prior to surgery is associated with the development of PONV.     The aim of this study is to investigate the effect of oral carbohydrates loading prior to     surgery in patients at high risk of PONV undergoing spinal surgery.   "
36351|NCT02809937|"     Delirium is a frequent postoperative complication. Its occurrence is associated with worse     long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose     dexmedetomidine infusion during the early postoperative period decreased the incidence of     delirium in elderly patients after surgery. The purpose of this 3-year follow-up study is to     evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 3-year     outcome in elderly patients recruited in the previous randomized controlled trial.   "
36352|NCT02809924|"     This study compares the use of simulation-based just-in-time training to video training in     learning neonatal endotracheal intubation. Half of the participants will be trained using     simulation-based just-in-time training and the other half using video training.      The hypothesis are      Primary hypothesis:      In the Neonatal Intensive Care Unit, use of simulation-based just-in-time training, compared     to video training, will increase the rate of successful clinical endotracheal intubation by     20%.      Secondary hypotheses:      The investigators expect that simulation-based just-in-time training prior to clinical     endotracheal intubation will decrease time to successful intubation and rate of endotracheal     intubation related adverse events, namely mucosal trauma, oesophageal and endobronchial     intubations. In addition, the investigators expect that simulation-based just-in-time     training will increase residents' confidence level while performing clinical endotracheal     intubation.   "
36353|NCT02809911|"     Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity     and nervous system response to various qualities of experimentally induced pain in the upper     and lower extremities of subjects with painful peripheral diabetic neuropathy.   "
36355|NCT02809885|"     Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia     and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype     found in Europe and North America and is responsible for sporadic infections except for     travel associated diseases.      HEV had a principally asymptomatic form. However, it was recently demonstrated that it could     lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver     transplanted patients the infection could mimic a rejection and lead to the loss of the     transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its     well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack     of information about the prevalence of this disease.      In Canada the incidence of HEV infection was high (15-86% for liver transplanted children     with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver & kidney     transplanted children whereas 7,4% in control. It was shown in a retrospective study that in     liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.      This study will determined in a prospective approach the HEV prevalence in kidney, lung,     heart and bone marrow transplanted children in Lyon.   "
36356|NCT02809872|"     The aim of this study is the feasibility assessment of a simple and affordable model for the     quantification of Pleural Effusion through thoracic Ultra Sounds images. Two US scans will be     performed to measure: the height of Pleural Effusion column (hPEUS) and the area of the     effusion in correspondence of the midline of hPEUS (aPEUS). The proposed model will estimate     the Pleural effusion volume (PEVUS) by multiplying hPEUS and aPEUS. PEVUS will be compared     with volumes estimated by CT scans (PEVCT), obtained within 24h from the US examination.   "
36357|NCT02808806|"     The purpose of the ARTEMIS trial is to investigate if real-time feedback to caregivers     reduces the time between patient's first medical contact and start of intravenous     thrombolysis and/or intraarterial thrombectomy in patients with acute ischemic stroke.   "
36358|NCT02808793|"     This is a Phase 1 study to investigate the safety and tolerability of AK002 in patients with     indolent systemic mastocytosis (ISM).   "
36359|NCT02808780|"     The purpose of this study is to compare the incidence of lymphoma in adult participants with     moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with     thiopurines.   "
36363|NCT02808728|"     Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively     manage post operative pain control than another local analgesic, Ropivacaine, when both are     used as part of a multimodal pain management approach?      The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension,     will improve total knee arthroplasty postoperative pain with significant improvement of early     function outcomes.   "
36364|NCT02808715|"     Chinese male subjects will be invited to participate in a research study of brown fat, a     special tissue in the body that is designed to burn energy to make heat. The objective is to     learn the importance of a gene called PRDM-16 for the function of brown fat. Subjects were     selected as a possible subject in this study because they fulfil the age and weight criteria.      500 subjects from the Singhealth Investigational Medicine Unit healthy volunteer database     will be recruited over a period of 2 years. All of the subjects will have their PRDM-16 gene     sequenced. The objective is to identify subjects with mutations, or changes, in their PRDM-16     gene. About 12 subjects with PRDM-16 mutations are expected to be identified.      Samples of blood obtained during the course of this study will be stored and analysed only     for the purposes of this study for a period not exceeding 2 years, and will be destroyed     after completion of the study, unless subject is agreeable to donate the samples to the     National Heart Centre Singapore for continuous storage for future studies that are approved     by the institutional review board..   "
36365|NCT02808702|"     The purpose of this study is to determine whether neuroimaging-based markers of maladaptive     self-focused processing are better predictors of treatment response to cognitive-behavioral     therapy than behavioral markers.   "
36366|NCT02808689|"     This is a pilot, proof of concept, early stage study. The study goal is to determine whether     the Functional Medicine approach to the treatment of moderate to severe persistent asthma     enhances standard guideline-based care with respect to asthma outcomes.   "
36367|NCT02809846|"     To study effects Quell has on opioid consumption and pain relief in patients with cancer.   "
36368|NCT02809833|"     This prospective, multicenter, non-interventional study will enroll participants from routine     clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study     is systematic collection of data on use of tocilizumab in daily routine with special emphasis     on treatment decision by the prescriber, compliance with Summary of Product Characteristics     (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The     maximum observation period will be 12 months per participant.   "
36369|NCT02809820|"     The Investigators will test the hypothesis that nonselective beta-blockers would have a more     pronounced effect on platelet aggregation than selective beta-blockers in patients with acute     coronary syndrome treated with dual anti platelet therapy.   "
36370|NCT02809807|"     Background: The gas mask is used to protect the aiways against respiratory hazards (CBRN     agents). Within the CBRNE committee, speculations are that unprotected lungs would look like     to those of COPD patients in post-exposure of some CBRNE agents. The aim of the study was to     evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory     effort. Methods: We are completing our study with 9 COPD patients to evaluate breathing     patterns, index of respiratory efforts and blood gases. Three conditions have been tested in     a randomized order: 1x baseline and 2x different canisters, with and without a mask (C4,     Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have     been measured. An esophageal catheter is introduced at the beginning of the study to measure     esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 is     continuously measured and capillary blood bases are drawn at the end of each condition. Each     condition lasts 10 minutes, data of the last 2 minutes at a steady state are considered for     analyses. Results. We are compiling data and processing them for analysis.   "
36371|NCT02809794|"     The study is to evaluate the product reliability, therapy effectiveness and user feedback of     a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.   "
36374|NCT02809755|"     The purpose of this study is to determine the efficacy of sphenopalatine ganglion (SPG) block     to prevent shoulder tip pain following primary laparoscopic gastric banding, band revision,     band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy. Shoulder tip     pain (STP) is a common problem after laparoscopic surgery, manifesting in the post-anesthesia     care unit and for days or possibly weeks thereafter (Dixon 2005). Systemic analgesics     including opioids and non-steroidal anti-inflammatory drugs (NSAIDs) do not reliably relieve     STP. This study is designed to determine if the SPG block, a simple and low-risk procedure,     effectively treats STP after laparoscopic bariatric surgery.   "
36375|NCT02809742|"     Enhanced patient safety and satisfaction have contributed to growing use of epidural labor     analgesia. Epidural analgesia appears to be currently the most effective technique in     reducing pain during labor. However, reduction in total dose of local anesthetic and thus     motor blockade is crucial to improve the obstetric outcome. This technique has evolved from     intermittent boluses by anesthesiologists to the current standard labor epidural analgesic     regimens in many institutions in North America and Europe that consist of a local anesthetic     in combination with an opioid delivered via continuous epidural infusion (CEI) with or     without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of     administration has been used: regular bolus of low concentration local anesthetic +     intermittent bolus (PIEB). This technique would offer safe and superior quality labor     analgesia and greater maternal satisfaction by reducing total amount of the drug combination.      The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in     terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The     secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric     outcomes, total drug dose and incidence of pain that required top-up administration     (breakthrough pain)   "
36376|NCT02809729|"     Breast cancer is the most frequent malignancy in the female population Brazilian, except     non-melanoma skin tumors. Surgery plays an important role in regional spot disease control     and the definition of parameters for the adjuvant treatment indication. Surgical site     infections (SSI) are defined as wound infections occur following invasive procedures,     corresponding to 14-16% of all infections nosocomial in hospitalized patients, the most     common among patients surgical. SSIs should be examined as potential wound contamination     surgical, understood as the number of micro-organisms in the body and / or tissue being     operated. Considering this aspect, the cancer surgery breast are classified by their     potential for contamination by clean. The use of antibiotics to prevent the SSI in     mastectomies is not standardized in Handbook of National Health Surveillance Agency due to     the effectiveness of undocumented prophylaxis Thus the use of antibiotics may vary among     services. So this randomized clinical trial to evaluate the influence of the use of     Prophylactic antibiotics in SSI rates in oncological breast surgery.   "
36377|NCT02809716|"     This research clinical trial studies high definition single cell analysis in blood and tissue     samples from patients with colorectal cancer which has spread to the liver. High definition     single cell analysis allows doctors to study the properties of cancer cells that are     sometimes found in the blood of patients and to determine how the genes and proteins in them     may change over time. Studying samples from patients with colorectal cancer in the laboratory     may help doctors learn more about how cancer spreads, as well as how to predict the disease     outcomes in patients with cancer.   "
36378|NCT02809703|"     The objective of the study is to determine the quality of life of patients in the years     following treatment with extracorporeal membrane oxygenation (ECMO). The study population     will include all adults treated with any configuration of ECMO at Duke University Medical     Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by     direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed them     while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses quality     of life. In addition, patients will be asked to opt-in to participate in a phone survey in     which they can give a narrative about their ICU experience and answer specific questions     regarding long-term comorbidities. Data will be stored in a secure online server which is     HIPAA compliant and analyzed by the department of anesthesiology statistical support     services. De-identified data will be shared with the WHO as specified in their usage     agreement.   "
36379|NCT02809690|"     This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission     tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate     cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that     is given through the vein to take detailed pictures of areas inside the body where the tracer     is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the     disease has spread.   "
36380|NCT02809677|"     The investigators propose a one-year, repeated measures, within-subject design to examine the     impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel     modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural     equation model (SEM) in order to explore longitudinal mediation between asthma outcomes     (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test     whether caregiver improvement preceded child asthma improvement, and SEM will test whether     improved adherence and/or decreased child anxiety/depression mediated the effect. The     investigators considered a randomized control trial, but it would not be ethically acceptable     to withhold medication from caregivers diagnosed with Major Depressive Disorder (MDD) for the     proposed one-year duration of the study. It is unlikely that potential participants in the     study would find this acceptable. Furthermore a controlled design is not necessary since the     investigators are not testing the efficacy of antidepressants for depression, but rather the     impact of improvement on caregiver depression on the child.   "
36381|NCT02809664|"     Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central     subclavian catheter by supraclavicular route in the newborn.   "
36382|NCT02809651|"     The investigators prospectively want to use the Infrascanner in patients with ischemic     stroke, patients with brain surgery, patients with brain tumors, patients with intracranial     hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up     after head trauma or headache to determine to positive and negative predictive value of the     Infrascanner in these different settings.   "
36383|NCT02809638|"     In clinical practice, compression ultrasound (CUS) has become an easy and reliable     noninvasive tool for the diagnosis of deep vein thrombosis (DVT).      Currently there are not validated methods to assess the biological age of venous thrombus,     and the date of onset of thrombosis. One potential technique to age DVT is ultrasound     elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well     known that thrombi harden as they age. The aim of this study will be to assess the ability of     UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively all     consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower     limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of     follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS     of the lower limbs, and at the same time to the ultrasound elastography by the physician     expert in vascular ultrasound. The specialist performing both examinations will be unaware of     the time of onset of DVT (acute or chronic). Then the patients will be divided into two     groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month     of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three     times in the same patient at the same visit, to assess the reproducibility of the technique.     The demographic data, medical history, physical examination and the results of CUS and     ultrasound elastography will be collected in a case report form (CRF) by another investigator     who does not perform the examinations. The blinded CRF will be submitted to a dedicated     committee for statistical analysis.   "
36446|NCT02808676|"     The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and     progressive resistance training exercises, combined with cognitive training and Vitamin D3     supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment     (MCI).   "
36384|NCT02809625|"     Brucellosis, also known as Mediterranean fever, undulant fever, or Malta fever is a zoonotic     disease caused by Brucella infection.With the rapid development of animal husbandry and     aquaculture and increasing consumption of dairy products in urban residents, the incidence of     this disease in Inner Mongolia and even in the mainland area of China is significantly     increased.      The disease can damage multiple systems including nervous system, circulatory system,     reproductive system and bone joints, etc. The sooner the diagnosis of brucellar spondylitis     is diagnosed and treated, the better will be the prognosis of the patients which can prevent     the development of severe complications and diminish the need for surgical therapy. Thus the     early diagnosis of brucellar spondylitis was of great significance.We quantitatively analyzed     the brucellar spondylitis with DCE-MRI to explore the application of DCE-MRI in the early     diagnosis of brucellar spondylitis.   "
36385|NCT02809612|"     Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological     condition that leads to extreme suffering for both the women involved but also their     partners. It has also been shown to be associated with poor quality of life, leading to     depression and anxiety states. When left untreated, the condition takes a very long time to     resolve, with a substantial associated disability and suffering. Both psycho-education and     internet-based interventions have been shown to be highly successful while they can be quite     affordable. This makes them highly cost-effective. The present study aims at evaluating the     effectiveness of such an intervention among a vulvodynia patient population from the clinics     of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians     and given access to the internet-based platform, where they will fill out questionnaires     during four different time-points, after randomization to the control or the intervention     group. The intervention group will also have access to multiple activities and information     material uploaded in the internet-based platform. Differences in pain, quality of life and     mental health parameter outcomes will be assessed at the end of the study. Should this     intervention prove effective, it will be implemented in clinical praxis in the four regions.   "
36386|NCT02809599|"     The study evaluates a theory-based educational intervention and implementation strategy on     the use of the Dix-Hallpike test (DHT) and Canalith Repositioning Maneuver (CRM) in a     community Emergency Department (ED) setting. The DHT and CRM are used to diagnose and treat     Benign Paroxysmal Positional Vertigo (BPPV).   "
36387|NCT02809586|"     Social media provides frequent interaction with online social networks, increasing exposure     to peer influences, which could affect alcohol use in negative or positive ways. The proposed     study will recruit adolescents and emerging adults using social media ads, and conduct online     screening, enrolling 900 risky drinkers in a randomized controlled trial comparing three     conditions: 8-week Social Media Intervention + Incentives, 8-week Social Media Intervention     Only, and an e-news attention control condition. These innovative design features will     provide the critical next step in harnessing social media to reduce alcohol misuse, which     could have enormous public health impact by altering the alcohol use trajectories of youth.   "
36388|NCT02809573|"     The purpose of this dose-escalation study is to assess the safety and tolerability of     treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients     with newly diagnosed peripheral T-cell lymphoma.   "
36389|NCT02809560|"     Asthma affects about 10% of children and 6% of adults in industrialized countries.     Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are     broadly involved in this pathology in experimental models and in humans. Many studies show     that the signaling pathways activated by the commitment of T receiver differ depending LT.     The identification of specific signaling pathways links to Th2 offer new therapeutic     approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium     channels sensitive channels Cav1 voltage, normally found in excitable cells where they are     defined as receivers dihydropyridine (DHP).      The goal of the present study is to show the presence of Cav1 channels in inflammatory cells     in allergic asthmatics and show overexpression of these channels in the peripheral blood     mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in     comparison with controls.   "
36464|NCT02808442|"     This study aims at evaluating the safety and ability of UCART19 to induce molecular remission     in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic     leukemia (B-ALL) ahead of planned allogeneic hematopoietic stem cell transplantation     (allo-HSCT).   "
36465|NCT02808429|"     This study will evaluate the safety, tolerability, dose response and efficacy of atacicept in     patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that     treatment with atacicept will reduce proteinuria compared to placebo.   "
36390|NCT02809547|"     It is important that patients who suffer from Rheumatoid Arthritis (RA) have their disease     monitored at an early stage, as well as when it is established. Presently, if a patient is to     be assessed by means of disease activity scores and blood tests, they must attend a hospital     appointment, which can be difficult for patients who live far from the clinic. It would be     beneficial to be able to monitor and reliably define and report a disease 'flare' at home.     Quite often, by the time the patient attends for an appointment, flare ups have subsided.     This study will evaluate the possibility for patients to take their own blood samples in the     comfort of their own home, by transferring finger prick blood droplets to a dried blood spot     sample (DBSS) card. Patients would then send the cards to the laboratory to test for     clinically relevant protein markers. The feasibility of 'remote' monitoring of the patient's     disease will be explored.   "
36391|NCT02809534|"     To assess the primary effects and safety of Anlotinib with placebo in patients with     Hepatocellular Carcinoma(HCC).   "
36392|NCT02809521|"     The purpose of the study is to see if one's liking and awareness of different types of     activities is related to one's activity pattern.   "
36393|NCT02809508|"     The purpose of FiSK Junior is to investigate whether intake of oily fish compared to poultry     affects cardiovascular risk markers, cognitive function, and behaviour in healthy children.   "
36459|NCT02808507|"     The purpose of this study is to compare three strategies for finding TB cases in a rural     Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2)     Conducting household contact investigations of newly diagnosed TB cases; 3) Providing     incentives to newly diagnosed TB cases and their contacts to promote contact screening for     TB. For each intervention, investigators will measure comparative effectiveness in terms of     cases identified as well as the cost-effectiveness and feasibility of implementation.   "
36460|NCT02808494|"     Sample Collection Study   "
36461|NCT02808481|"     Systemic sclerosis is a rare disease. The early cardiac disease affects 10% of patients     sclérodemiques.      Heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional.      we see patient data analysis with systemic sclerosis who used cardiac transplantation to     understand the primitive cardiac damage associated with systemic sclerosis   "
36394|NCT02809495|"     Prostate cancer (PC) is the most common non-skin tumor in men and the second leading cause of     death from cancer in Brazil. It accounts for 13.8% of deaths from cancer in males, similar to     what happens with breast cancer in females, corresponding to 15.8% of cancer deaths in women.     Mobile applications, software developed for smartphones and tablets used for many different     purposes (games, communication, entertainment etc) have become important tools of mHealth     (Mobile Health in Portuguese - mobile health) as they allow remote support to patients or     self-promotion of health care. It has been used globally to assist in the treatment and     control of various diseases such as diabetes, physical inactivity, and many others. In     oncology there are several applications developed to assist in the monitoring and treatment     of various cancers such as gastric and breast cancer. So far it has not developed an     application for follow-up of patients with PC, to capture data on satisfaction of     post-treatment patient regarding the comorbidity of surgery, and also loyalty and adherence     of patients to follow-up in offices allowing a possible intervention it is done at the right     time. Nor was made compared to assess whether there is benefit in using this application.     Thus, the objective of this work is to develop an application for smartphones facing the     postoperative follow-up of patients undergoing robotic radical prostatectomy and compare     adherence to treatment compared to accompanied by traditional way patient. In addition, we     will evaluate the progress of the IPSS, ICIQ and IIEF-5 compared to preoperatively in     patients undergoing prostatectomy robotic radical.   "
36396|NCT02809469|"     Apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial     fibrillation (AF). Phase III clinical trials have demonstrated that apixaban is efficacious     and safe for the overall AF population; however, patients older than age 85, with creatinine     clearance <40mL/min, or who weighed <50kg were poorly represented in these trials, yet they     are commonly seen in real-world clinical scenarios. Advanced age, poor renal function, and     low body weight are all associated with elevated drug levels, and elevated drug levels are     associated with an increased risk of bleeding. Therefore, clinicians are concerned about the     risk of bleeding and are unsure of how best to treat this patient population. Although other     anticoagulants are available, apixaban is attractive because it has a low rate of bleeding,     low dependence on the kidneys for clearance, and does not require frequent ongoing monitoring     and dose adjustment. This study will include patients taking apixaban who were not     well-represented in phase III trials - those with age >85, creatinine clearance <40mL/min, or     weight <50kg - who are also at increased risk of having elevated drug levels due to these     clinical characteristics. Participants will have apixaban levels measured, and those with     persistently elevated levels will have their dose reduced. Drug levels will be measured again     after dose reduction to determine if the levels are reduced without becoming dangerously low.   "
36397|NCT02809456|"     This project will test the effect of nicorandil to mitigate the lung damage that can occur as     a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung cancer     every year, and are treated by radiation therapy. Studies of lung radiation injury in     laboratory animals show that with nicorandil, investigators can significantly reduce the     severity of lung fibrosis and heart toxicity.1,2 Nicorandil is FDA approved and in common use     for treatment of angina. These studies will advance that work to human use. Successful     mitigation of lung radiation damage and heart toxicity will improve the quality of life in     veterans and non-veterans who are treated for lung cancer by radiation, and may also improve     cure rates of radiation therapy for lung cancer.   "
36398|NCT02809443|"     The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.     GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. ZIKA-001 is the first in     man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope     regions of Zika virus.      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South     America, Central America, and the Caribbean islands commencing in late 2014 or early 2015.     Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in     adults and microcephaly and other birth defects among children born to mothers who are     infected during pregnancy. At present no vaccines or treatments have been approved for Zika     virus infection.   "
36462|NCT02808468|"     The broad aim of this study is to develop and test a brief intervention that can be     implemented in the immediate weeks following sexual assault to decrease likelihood of     developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the     study will enroll 6 women to complete a brief, cognitive therapy protocol and provide     feedback on the intervention (open trial). The second phase of the study will recruit 76     women to complete either the intervention (38 women) or assessment only (38 women) to test     the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to     natural recovery following assault.   "
36463|NCT02808455|"     This was a randomized, 2-period, 2-treatment-sequence crossover study to determine the     relative bioavailability of pacritinib following administration as a 400 mg oral dose of four     100 mg pacritinib capsules and an 80 mg dose of an oral solution and to characterize the PK     and major human metabolites of pacritinib.   "
36399|NCT02809430|"     Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with     continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence.     In this study, the investigators will enroll eligible stroke patients undergoing inpatient     rehabilitation into an intensive CPAP adherence protocol (iCAP) with an aim to increase     tolerance and adherence to auto-titrating CPAP (APAP). The iCAP will include patient     education and encouragement, device adjustments, close monitoring of adherence and a 3-night     run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP tolerance.     If both criteria are met, APAP treatment with iCAP will continue during the rehabilitation     stay and over a 3-month period. The goal of the intervention is to achieve 50% of subjects     meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period.     The investigators will evaluate if demographic, co-morbid or stroke-specific factors predict     APAP adherence and assess the relationship between APAP adherence and neurological recovery.     Successful completion of the project will establish the feasibility of a definitive trial     assessing the ability of APAP to improve stroke recovery in the short-term and reduce the     risk of recurrent stroke in the long-term.   "
36400|NCT02809417|"     This project is associating partners from the public area (university hospital of Nice, Nice     university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique     medico-psycho-social shared record.      The purpose of this project is to significantly improve coordination of care, especially     between hospital and home. We can expect a significant improvement in the patient's living     conditions, improving its management, its security and ultimately, lower health care costs.   "
36401|NCT02809404|"     Everolimus shows a large interpatient variability with fixed dose administration. These very     different exposure levels between individuals can result in supratherapeutic or     subtherapeutic exposure levels and consequently in over- or undertreatment, respectively.     Dose individualization based on the measured drug concentration could theoretically result in     less toxicity and more efficacy.      Nowadays everolimus exposure is determined by everolimus concentration in whole blood.     Therefore, a vena puncture is always necessary. This is invasive and requires patients to     come to the hospital. It would be convenient for patients to have their everolimus blood     concentration determined by dried blood spot (DBS) analysis. With DBS only a single drop of     blood from the finger is necessary, which can be done at home and sent by regular mail for     analysis. Previous studies have shown the feasibility of this approach. In patients with     cancer treated with everolimus 10mg once daily, the correlation between everolimus DBS     concentrations and whole blood concentration is yet unknown. Therefore, the investigators     want to determine the everolimus concentration collected with DBS from a finger prick with     everolimus concentration from whole blood and everolimus concentration collected with DBS     from whole blood.      In addition, possibly a relatively high everolimus concentration in saliva could be     correlated with the incidence and severity of oral mucositis. Determination of drug     concentration in saliva has also been proven to be feasible before.      Therefore, in this study the investigators want to determine whether the everolimus     concentration in saliva correlates with the incidence of oral mucositis and how everolimus     concentration in saliva correlates with everolimus concentration in whole blood.   "
36402|NCT02809391|"     The purpose of this study is to increase clinical knowledge of the relationship between     increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives of     this study are to determine if orthotics, with and without a textured top cover, can alter     muscle activation, gait parameters, balance, functional mobility, and decrease fall risks in     Parkinson's participants.   "
36403|NCT02809378|"     The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown     to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may     increase patient discomfort, delay patient discharge, and increase the cost of patient care,     the risk of postoperative bleeding which may potentially cause airway obstruction.      It is reported that the maintenance of anesthesia with propofol-remifentanil or     sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone,     but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in     patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3     antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly     during this period.      The purpose of this study was to evaluate and compare the incidence of PONV after     thyroidectomy with three different anesthetic methods, sevoflurane or     sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman     patients.   "
36404|NCT02809365|"     This is a randomized controlled study in type 2 diabetic patients who are presently     uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients     need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle     Libre for 10 weeks.   "
36405|NCT02809352|"     Cervical cancer is due to a persistent infection with a group of viruses known as high-risk     Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a     procedure called 'HPV testing', which can be used as a relevant screening test. A pilot     screening program called START-HPV has been set up in the Ardennes, a French administrative     area localized in the North of France, with HPV testing as a primary screening test.This     observational study aimed to evaluate hrHPV genotypes repartition in the population who     participate in the START-HPV screening program. This study will allow a better knowledge of     hrHPV infection epidemiology in a screened population.   "
36406|NCT02809339|"     Ovarian cancer is a major cause of cancer related death among women. The disease is usually     advanced at diagnosis, because specialist referral is delayed due to vague nature of     presenting symptoms. Primary treatment is successful, but most patients experience     recurrence. Complaints due to disease and therapy overlap. Furthermore treatment schedules     are similar in response rate and survival rates. Toxicity of therapy as scored by the     physician is best documented, but varies depending on type of chemotherapy. Moreover most     knowledge is acquired in clinical trials and not in daily practice. Patient reported outcome     (PROs) concerning effects on symptoms, velocity of relief and quality of life (QoL) by the     different regimens is sparce. Also it is unknown which symptoms are best relieved. Most     trials take into account progression or survival as primary endpoint but not often symptom     relief, which is especially important for patients with recurrent disease, without no chance     of cure anymore. Knowledge on rating of problems and needs of patients with recurrent ovarian     cancer (ROC) to support them in the course of their disease is needed to come to an evidence     based and patient centered treatment of choice together with the patient. Physicians most     frequently use the Common Toxicity Criteria (CTC) scale for grading of side effects of     treatment, but discrepancies with patient experiences is high. Routine collection of PROs may     therefore improve patient expectations and management. In this project the investigators     intend to augment knowledge by PROs of different chemotherapy schedules for recurrent ovarian     cancer in order to improve shared decision making with the physician.      Objective: primary objective of this project is to explore the relief of symptoms due to ROC,     the speed with which this occurs by different chemotherapy schedules and development of     complaints due to the regimen of chemotherapy. Secondary the investigators intend (1) to     assess preferential symptom relief by patients, (2) to correlate toxicity and symptoms of     disease to tumor assessed response to chemotherapy and (3) to correlate symptom relief by     psychosocial context.   "
36407|NCT02809326|"     This trial will evaluate the efficacy and efficiency of Trauma Management Therapy (TMT;     Frueh, Turner, Beidel, 1996; Beidel, Frueh, Uhde, under preparation), which combines     individual virtual reality (VR) assisted exposure therapy with group social and emotional     rehabilitation skills training (will be superior to a treatment consisting of the same VR-     exposure and group psychoeducational group therapy. TMT will be conducted in traditional     17-week format, and a 3-week intensive treatment format. Outcome will be assessed using     relevant clinical, process, and cost outcomes. Additionally, investigators will assess the     potential of olfactory stimulation as a trigger for PTSD symptoms of intrusive thoughts and     re-experiencing. Therefore, this proposal will integrate clinical and neurobiological     assessment studies designed to understand the role of these factors in the etiology,     maintenance, and treatment of PTSD.   "
36408|NCT02809313|"     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of     Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root     planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and     monitored clinically and microbiologically at baseline and 3-6 months after therapy. All     patients will receive scaling and periodontal treatment and randomly will be assigned over an     experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet will     be used once per day during 3 months.   "
36409|NCT02809300|"     The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in     patients with ankylosing spondylitis (AS).      The secondary objectives are: (1) To determine whether the presence of these antibodies is     symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of     APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence     of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha     therapy.   "
36410|NCT02809287|"     Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H.     Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages     in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well     recognized globally. Generally speaking, for lesions located in the left, front or lower part     of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is     recommended; however, for lesions located in segments VII and VIII, the surgery is high     technically difficult due to poor exposure. Therefore,the investigators employ the left     lateral position plus jackknife position to better expose lesions in these segments, hoping     to reduce surgical time and bleeding in LH.   "
36411|NCT02809274|"     Iron deficiency is a known feature of PV, occurs because of accelerated erythropoiesis,     gastrointestinal blood loss and phlebotomy. Incidence and effect of iron deficiency in these     patients is not well characterized. The study will assess the incidence of iron deficiency at     diagnosis and during the course of PV, assess effect of iron deficiency on patient symptoms     and its correlation with disease features.      This is a multicenter, non-interventional, non-randomized, prospective, observational study     in an adult population (patients >18 years old) of patients who have been diagnosed with PV     and are being followed in either community or academic medical centers in Israel.   "
36412|NCT02809261|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Rather than other progressive     disease, CTS is characterized by remission and recurrence. Although many conservative     managements of CTS, the effectiveness of these methods is insignificant or only persist for a     short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was     widely used for entrapment neuropathy with positive benefit. However, current studies have     not entirely proved the effects of perineural injection on peripheral neuropathy because     these studies enrolled small number of patients and lacked controlled design. The     investigators design a randomized, double-blind, controlled trail to assess the effect after     ultrasound-guided perineural injection with 5% dextrose in patients with CTS.   "
36413|NCT02809248|"     The aim of the study is to choose an optimal stent and to get further knowledge about the     mechanisms of the engraftment of a stent.      The occurrence of a hyperplasia of neointima can be minimized by application of a coated     stent and a concurrent safety four weekly dual thrombocytes therapy   "
36466|NCT02808416|"     Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce     limited efficacy. Recent advance in cancer immunotherapy has provided important new means to     treat cancer patients at advanced stages. This study is designed to perform a clinical trial     to treat advanced caner patients with brain metastases with personalized cellular vaccines.     The patients will receive vaccines consisting of autologous tumor cells, tumor antigen pulsed     DCs and peripheral blood mononuclear cells (PBMCs). Safety and efficacy will be observed in     this study.   "
36467|NCT02808403|"     The purpose of this post-marketing survey is to obtain real-world information on the safety     and effectiveness of evolocumab in Japan.   "
36468|NCT02808390|"     This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group     study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with     active, mild-to-moderate UC.   "
36414|NCT02809235|"     In this proof of concept study, the investigators aim to determine if supplementation with     coconut oil causes an increase in cholecystokinin and cholecystokinin receptor expression in     the airway smooth muscle of lean asthmatics, and whether these changes correlate with changes     in airway stiffness (estimated by bronchodilator reversibility, airway reactivity, and airway     resistance) or symptom control.      The investigators propose a 5 week, single center trial in 20 lean patients with mild asthma     (not taking inhaled corticosteroids) aged 18 and older. Subjects will supplement their usual     diets with 3 tablespoons of coconut oil, a commercially available oil with high dodecanoic     acid content, for 3 weeks. To quantify changes in airway smooth muscle cholecystokinin and     cholecystokinin-receptor expression, each subject will undergo bronchoscopy with     endobronchial biopsies before and after coconut oil ingestion.      For the secondary analysis, subjects will also complete spirometry with bronchodilator     testing, methacholine challenge, body plethysmography, and an Asthma Control Questionnaire     (ACQ) before and after the dietary intervention. This information will be used to compare the     changes in airway smooth muscle cholecystokinin and cholecystokinin receptor expression to     changes in bronchodilator reversibility, airway reactivity, airway resistance, and symptom     control.      In the exploratory aims, the investigators will correlate the changes in airway smooth muscle     cholecystokinin and cholecystokinin receptor expression with changes in FEV1 and peak flow     measurements.      The investigators therefore hope to elucidate information about the mechanistic role of     cholecystokinin in airway smooth muscle stiffness and contraction.   "
36415|NCT02809222|"     Myelodysplastic syndromes (MDS) is a group of heterogeneous diseases characterised by the     clonal evolution of dysplastic hematopoietic stem cells. This evolution is associated with     accumulation of cytogenetic mutations which leads to acute myeloid leukaemia (AML). Evolution     of MDS is also associated with increase of reactive oxygen species (ROS). The increase of ROS     is associated with accumulation of cytogenetic mutations. Ascorbic acid (AA) is an actor of     the regulation of the oxidative metabolism in the human body.      Studies showed that supplementation with AA can change the proliferation status of MDS cells.     Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and     AML. The present study aim at describing the variations of plasmatic ascorbic acid     concentrations between healthy volunteers and patients with myelodysplastic syndromes     advanced in their treatment or recently diagnosed during a follow-up of 12 months.   "
36416|NCT02809196|"     The overall objective is to examine if participating in an SMS-transmitted health educational     program targeting a cluster of dietary factors over a period of weeks during the years of     adolescence can induce durable changes towards more healthful dietary habits. The     investigators will examine if impact is reinforced by asking a friend of the participant to     also participate; if impact is reinforced by asking the mother of the participant to also     participate; and if impact is reinforced when the SMS-transmitted health promotion program is     designed to target a specific dietary factor only - decided upon from participants' reporting     of their dietary habits at the beginning of the program - rather than to simultaneously     target a cluster of dietary issues uniform for all participants.   "
36417|NCT02809183|"     This is a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The     study will enroll approximately 130 adult male and female subjects with Stage 3 or 4 chronic     kidney disease and low serum bicarbonate levels. The study will be conducted in two parts. In     Part 1 study drug dosing (TRC101 or placebo) will continue for 14 days twice daily. In Part 2     study drug dosing (TRC101 or placebo) will continue for 14 days once daily.      The maximum study duration is anticipated to be up to 42 days.   "
36418|NCT02809170|"     Mitochondrial diseases occur due to inadequate energy production. In addition, nitric oxide     (NO) deficiency occurs in mitochondrial diseases. The endothelial layer of blood vessels     functions in maintaining blood vessels patency through producing NO which relaxes vascular     smooth muscles and therefore maintains the patency of blood vessels and adequate blood     perfusion. In mitochondrial diseases, endothelial cells fail to perform their normal function     in maintaining the patency of blood vessels (endothelial dysfunction) because of the     inability to produce enough NO. Endothelial dysfunction results in decreased blood perfusion     in different organs which can contribute to the complications seen in mitochondrial diseases.     The amino acids arginine and citrulline act as NO precursors and can increase NO production.     In this study we hypothesize that due to the inability to produce enough NO patients with     mitochondrial diseases have endothelial dysfunction that will improve after arginine or     citrulline supplementation. The investigators will assess endothelial function using     peripheral arterial tonometry before and after arginine or citrulline supplementation. The     investigators expect that arginine and citrulline supplementation will improve endothelium     function. This will support the therapeutic use of arginine and citrulline in mitochondrial     diseases.   "
36419|NCT02809157|"     Coronary artery disease (CAD) is a very common cause of heart failure affecting millions of     people worldwide, which is caused by build-up of plaque inside arteries of the heart.     Build-up of plaque eventually impacts the blood supply to the heart. In medicine, techniques     (invasive or non-invasive) such as coronary angiography, intravascular ultrasound, computed     tomography, magnetic resonance imaging, positron emission tomography and transthoracic     echocardiography can be used to diagnose CAD.      The investigators aim to study Coronary Artery Disease significance with the combination of     computed tomography angiography (CTA), and computational fluid dynamics (CFD) methods. CTA is     a non-invasive technique to visualize arterial vessels, which uses computer-processed x-rays.     Computational Fluid Dynamics employs digital computers and numerical methods to solve complex     flow patterns inside arterial vessels. Combining these two methods, the investigators are     able to provide detailed blood flow information and mechanical stress distributions on the     vessels. This study therefore, aims to propose a non-invasive methodology to assess the     significance of CAD.   "
36420|NCT02809144|"     Interscalene block has been the traditional regional anesthesia for shoulder surgery and     postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury     have encouraged search for alternative methods.   "
36469|NCT02808377|"     This is an RCT looking at the primary outcome of composite success following anterior repair     with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft     silicone pessary inserted into the vagina post operatively for three weeks and the other will     not.   "
36421|NCT02809131|"     The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown     rapidly over the past two decades. CIED infections, defined as infections involving the     generator implant site (pocket) and/or intravascular leads, have become increasingly     prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds     of both short term and long term mortality are at least doubled in patients who suffer CIED     infections, and long term survival is particularly poor in women. Optimal strategies to     prevent CIED infections in high-risk patients are largely unproven. However, recent     observational studies of an antibiotic-coated envelope implanted at the time of CIED     procedure have shown that this strategy is associated with a low incidence of CIED     infections. Other interventions to prevent CIED infections, including the use of antibiotic     irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are     commonly used but not supported by rigorous controlled studies. The Specific Aim of this     study is to test the hypothesis that the use of the antibacterial envelope alone is     noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial     irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device     infections in patients with ≥2 risk factors for infection.   "
36422|NCT02809118|"     The primary objective of the trial is the confirmation of the efficacy of AM-111 in the     recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).   "
36423|NCT02809105|"     The objective of this study is to verify the efficacy and investigate the safety of the study     drug when ASP0456 is administered orally for 4 weeks and 52 weeks.   "
36424|NCT02809092|"     Relapsed acute myeloblastic leukemia (AML) requires remission prior to allogeneic     Hematopoietic Stem Cell Transplant (HSCT) for optimal survival, but is a disease with poor     response to chemotherapy. Human leukocyte antigen (HLA) haploidentical, Natural killer (NK)     enriched peripheral blood cell infusions have shown safety in patients with poor prognosis     AML. Though not powered for such an assessment, this trial showed a promising but not     statistically significant trend in remission rate. NK cell therapy was limited by small     numbers of NK cells attainable through leukapheresis. We have now demonstrated that large     numbers of NK cells can be propagated ex vivo from a small volume blood draw, obviating the     need for donor leukapheresis. The purpose of this trial is to determine the feasibility and     maximum tolerated dose of expanded NK cells and estimate the toxicity of treating     relapsed/refractory AML with fludarabine + high-dose cytarabine + G-CSF (FLAG) chemotherapy     followed by haploidentical expanded natural killer (NK) cells.      The first NK cell dosing cohort will be well below the currently-established safe dose of     pheresis-derived NK cells, as expanded NK cells may have increased toxicity because of their     activated phenotype. In order to avoid accruing patients at suboptimal doses, a dose     escalation schema based on the principles of an accelerated titration design is used in this     study to allow expeditious advancement up to the current safe dose of NK cells.   "
36425|NCT02809079|"     Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central     nervous system that leads to blindness and paralysis. Since disability accrues incrementally     related to attacks, attack prevention with immunosuppressive therapy is the mainstay of     preventing disability. However, there is no standard immunosuppressive treatment strategy for     NMO relapse prevention. In a previous study, the investigators provided evidence supporting     the use of azathioprine plus a low dose corticosteroid as an effective strategy which is     associated with a reduction in the risk of relapse in Chinese patients with NMO, but     azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF)     is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In     recent years, MMF has been used in different immune-related neurological diseases; some     literature shown the possible efficacy of MMF in NMO treatment.      In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University,     Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical     University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil     therapy in NMO spectrum disorders.   "
36426|NCT02809066|"     This study was planned and conducted to investigate effect of adequate calcium intake on     Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.   "
36427|NCT02809053|"     This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the     statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as     a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden     Follicular Lymphoma.   "
36428|NCT02809040|"     Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to     high blood pressure. In patients with HHD, abnormalities in the way heart muscle relaxes and     how heart chambers passively fill with blood (diastolic dysfunction) can occur that may be     detected on echocardiography (echo), which is a standard clinical method to examine heart     structure and function using reflected sound waves. Investigators propose to develop a     digital auscultation system or electronic stethoscope based on wireless sensor node     technique. Investigators hypothesize that the heart sounds measurements detected by     electronic stethoscope can be used to detect heart diastolic dysfunction in HHD .   "
36429|NCT02809027|"     The purpose of this study is to determine ginger is effective in the prevention of abdominal     distention in post Cesarean section patient.   "
36470|NCT02808364|"     The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for     glioblastoma has shown some efficacy. This study is designed to perform a personalized     clinical trial by first analyzing the expression of tumor associated antigens in patients     with recurrent glioblastoma and then immunizing the patients with personalized cellular     vaccines including autologous tumor cells, antigen pulsed DCs and allogeneic peripheral blood     mononuclear cells (PBMCs). Safety and efficacy will be observed in this study.   "
36532|NCT02807545|"     This study will be a multi-center, dual-arm randomized control study evaluating skeletally     immature patients with mild AIS curves. At six institutions, patients will be randomized into     either the scoliosis-specific exercise (SSE) treatment arm or a control group. The SSE group     will receive training in SSE, posture, and activities of daily living by physical therapists     certified in Schroth-based exercise methods. The control group will not receive SSE     instruction and will only be observed by their treating orthopaedic surgeon (which is     considered the standard-of-care treatment method). Results will be compared after one year of     treatment.   "
36430|NCT02809014|"     The literature recognizes that fluoride is the most widely used and studied means for dental     remineralization. The use of fluoride toothpaste in brushing is considered more rational     method for the prevention of caries. However, the current challenge of toothpaste is the     substantivity, so new compounds have been introduced into these formulations. This study aims     to evaluate the in vivo effect of fluoride dentifrice containing a natural product -     hydrocolloid tara gum - in fluoride retention in saliva and dental plaque. A study of the     clinical and laboratory type, crossover, double-blind, randomized will be held. After sample     calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed,     missing, and filled teeth index less than 6 and residents in brazilian northeast capital will     be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva     after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after     brushing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after.     It will be 4 toothpastes: 1100ppm F- with hydrocolloid; F- 550ppm with hydrocolloid; 1100ppm     F- without hydrocolloid; Without fluoride with hydrocolloid. Between weeks of use, brushing     will be extended washout (without fluoride and no hydrocolloid) to avoid carryover effect.     inferential data analysis will be carried out, considering the amount of alpha <0.05. So     knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids     promoted by the hydrocolloid may have important impact on Des-Re process and in the control     of dental caries.   "
36431|NCT02809001|"     The purpose of this study is to evaluate whether autologous fat grafting is safe and/or     effective to prevent expanded skin from expansion failure.   "
36432|NCT02808988|"     The investigators evaluated the effect of initial periodontal treatment on clinical findings     and receptor activator of Nuclear Factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in     gingival crevicular fluid (GCF) of patients with osteoporosis under bisphosphonate therapy     within 12 months' follow-up. Clinical recordings and GCF were obtained from postmenopausal     women; with chronic periodontitis and osteoporosis (Group A, n=13), with chronic     periodontitis and no osteoporosis (Group B, n=12), without chronic periodontitis and     osteoporosis (Group C, n=12), systemically and periodontally healthy controls (Group D, n=10)     at the baseline. Recordings were repeated at the 1st, 6th and 12th months in Group A, B and     C. RANKL and OPG values were measured by enzyme-linked immunosorbent assays.   "
36433|NCT02808975|"     The objective of this study is to assess the safety and efficacy of adalimumab prior to     surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical     candidates.   "
36434|NCT02808962|"     The procedure is supposed to ablate the sacral lateral branches that form the medial cluneal     nerves (MCN). The anatomy of the sacral lateral branches is such that, in addition to     innervating the SIJ, distal branches of these nerves also innervate the skin over the buttock     through MCN (12,13). SLB blocks (usually with 0.5 ml of 1% Lidocaine or 0.5% Bupivacaine) are     performed proximal to the origin of both the nerves to the SIJ and the cutaneous branches.     Therefore, a technically accurate block should anesthetize not only the SIJ but also the skin     of the buttock regardless of the patient symptoms. Hypoesthesia of the buttock would,     therefore, be a quality-assurance sign that the block has been performed in a technically     correct fashion. Similarly, if the target nerves have been accurately ablated by RFA     hypoesthesia of the buttock should ensue, as an expected effect of the procedure.   "
36436|NCT02808936|"     The investigators attempt to investigate the organ protective effect of remote ischemic     conditioning in patients undergoing non-cardiac surgery with history of ischemic heart     disease.   "
36437|NCT02808923|"     The purpose of this study to to compare the long-term effects of foam rolling in comparison     to static stretching and a control group on hamstring flexibility. The investigators     hypothesize that participants in the foam rolling and static stretching group will     demonstrate increased flexibility to the control group, but will a difference will not be     observed between the foam rolling and static stretching groups.   "
36438|NCT02808910|"     This study will investigate whether small changes (nudges) made in a cafeteria, where     participants eat for 4 weeks, can improve their food behavior and health during the 4 weeks,     and 6 weeks and 6 months after their stay. Half the participants will be exposed to one of     four types of nudges (focused on reducing salt intake, increasing vegetable intake, reducing     portion size, and a combination of these nudges), and half of the participants will eat in     the cafeteria as it is currently, without modifications.   "
36439|NCT02808897|"     The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Clearance     Technology® (ACT) in reducing the rate of postoperative atrial fibrillation (POAF) among post     cardiac surgery patients and to evaluate the impact of ACT on other complications, such as     retained blood syndrome (RBS), a composite endpoint including re-exploration for bleeding or     tamponade, and interventions for hemothorax, pericardial or pleural effusion.   "
36440|NCT02808884|"     The investigators have developed an assay that can sensitively and specifically detect DNA     mutations circulating in human plasma that may be indicators of the presence of a solid     tumor. This study is a pilot study to measure positive and negative predictive values of this     assay as an indicator of the presence of a tumor in normal subjects   "
36441|NCT02808871|"     The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403     mg/day for the treatment of RA-associated interstitial lung disease.   "
36442|NCT02808858|"     Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS)     newly diagnosed.   "
36443|NCT02808845|"     The purpose of this study is to investigate the association between pre-existing     microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary     angiography (CAG).   "
36444|NCT02808832|"     The purpose of this study is to develop, deliver and evaluate a provider intervention for     mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in     the children and appropriate cervical cancer screening in the mothers.   "
36445|NCT02808819|"     The purpose of this study is to continue to characterize the safety profile of benralizumab     administration and monitor the pharmacodynamic activity of the drug in those asthma patients     who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor     study D3250C00021 (BORA).   "
41038|NCT02748473|"     Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve     the pelvic floor muscle strength on sedentary nulliparous women.   "
36447|NCT02808663|"     Severe alcoholic hepatitis, defined by a Maddrey discriminant function above 32, is     associated with significant short-term mortality. In patients with liver disease, studies     have shown alterations of intestinal bacterial flora and an increase in intestinal     permeability leading to bacterial translocation across the intestinal barrier. The mechanism     involved may be an activation of intestinal macrophages with a local release of cytokines     like interleukin-8 (IL-8).      Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its     presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal     calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal     calprotectin levels are increased in cirrhotic patients dependent on the severity of the     disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic     hepatitis has never been evaluated.      The main objective of this study was to determine if the initial level of fecal calprotectin     and its variation after 7 days had a predictive value for the outcome of severe alcoholic     hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was     correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and     predictive of infections.   "
36448|NCT02808650|"     This phase I trial studies the side effects and best dose of prexasertib in treating     pediatric patients with solid tumors that have come back after a period of time during which     the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1     inhibitor LY2606368 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.   "
36449|NCT02808637|"     This is a randomized double-blind controlled study and was performed to compare effects of     rapid injection without aspiration and 10-second manual pressure before injection on pain     severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.      The study population included all the infants presenting for DTaP/IPV/Hib to two family     health centers between April and August in 2015. The study sample included 128 infants based     on confidence interval of 95% and statistical power of 80%. The sample was divided into four     groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined     with rapid injection without aspiration and control groups. There were 32 infants in each     group. Gender was adjusted in all groups. Stratified and block randomizations were used.   "
36450|NCT02808624|"     This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced     peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin     and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And     then neuropathy together with some oxidative stress markers will be assessed at the end of     treatment duration (three months) .   "
36451|NCT02808611|"     An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms     can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy     controls and pain patients. A number of studies indicate that the autonomic nervous system     (ANS) responds to painful stimulation by parasympathetic activity withdrawal and     up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether     these responses predict individual pain susceptibility or CPM efficacy and whether different     pain modalities evoke different physiological stress responses, i.e. do individuals with low     pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain     stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain     levels/CPM efficacy.      This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to     investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of     the ANS will yield decreased CPM efficacy.   "
36452|NCT02808598|"     The purpose of this study is to test a program designed to increase African American and     Hispanic American women's scientific literacy, knowledge of clinical trials, and to     facilitate breast cancer clinical trial participation.   "
36453|NCT02808585|"     This study will be a sequential multiple-dose escalation study that will enroll (randomize     and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in     Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive a     fixed weekly dose of study drug or placebo for a 4 week dosing period.   "
36454|NCT02808572|"     To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin,     fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a     3 year follow-up.   "
36455|NCT02808559|"     To quantify the severity of psoriasis in a consistent and clinically meaningful way is     important in order to decide the therapeutic orientation to take for the patient. PASI     (Psoriasis Area and Severity Index) scoring is recognised as gold standard for psoriasis     assessment. The bodystudio ATBM (Automatic Total Body Mapping) is a high-tech system     performing standardized photos from head to feet and from all angles, which allows to map the     entire skin covering all the human body in a few minutes.The primary objective of this study     would be to evaluate the ability of the bodystudio ATBM to calculate the PASI score of     patients with psoriasis human body in a few minutes   "
36456|NCT02808546|"     The main purpose of this study is to investigate the region-specific cause of gallbladder     stone incidence in Jeju Self-Governing Province, Korea.   "
36457|NCT02808533|"     Clozapine is the sole AP agent with superiority in treatment refractory schizophrenia, but it     also is associated with the greatest risk of weight gain and other metabolic abnormalities.     Topiramate, an anticonvulsant agent, possesses a weight-reducing effect. Furthermore, some     studies have suggested that Topiramate may be associated with improvements in psychopathology     in treatment refractory schizophrenia. Here the investigators propose to determine the role     of topiramate for augmentation purposes (psychopathology) and as an adjunctive     pharmacological intervention for weight loss in overweight/obese individuals with     Ultra-Treatment Resistant Schizophrenia or Schizoaffective disorder taking clozapine.   "
36458|NCT02808520|"     Purpose of this study is to determine the influence of social factors on participation and     activity among children and adolescents aged 10-18 years with hodgkin-lymphoma. Furthermore     personal and treatment-related factors and their impact on participation will be explored.   "
36533|NCT02807532|"     To investigate whether apelin can be used as an indicator to predict postoperative atrial     fibrillation in patients with coronary atherosclerotic heart disease, and to provide an     objective basis for the clinical selection of a preventive intervention program for atrial     fibrillation.   "
36471|NCT02808351|"     The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased     steadily in recent years. This has resulted in the increasing incidence of contrast-induced     nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM),     chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic     instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a     patient with CKD it amplifies the risk of CIAKI.      The aim of this multicenter prospective, randomized, controlled study is to evaluate whether     berberine treatment during and after the perioperative period would reduce the risk of CIN in     a high-risk population of patients with both DM and CKD undergoing coronary angiography or     noncoronary angiography, and the influence of such potential benefit on short-term outcome.   "
36472|NCT02808325|"     It is the objective of the study to investigate the efficacy and safety of two different     volume replacement regimens with gelatine solutions.   "
36473|NCT02808312|"     The primary objective of this study is to evaluate the single-dose pharmacokinetics of     GS-9674 in adults with impaired hepatic function relative to matched, healthy controls with     normal hepatic function.   "
36474|NCT02808299|"     The purpose of this study is to investigate the incidence of liver injury by statins in     coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.   "
36475|NCT02808286|"     The aim of this project is to evaluate a hybrid emotion-focused treatment protocol,     specifically developed for individuals who suffer from co-occurring chronic pain and clinical     levels of anxiety and/or depressive symptoms.      Specific questions relating to treatment outcome:        1. Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional          symptoms (pain-related fear, anxiety, depression)?        2. Does a hybrid emotion-focused treatment lead to an increase in functional ability,          improvement in work status and decrease in medication use?        3. Does a hybrid emotion-focused treatment lead to better treatment effect on the above          outcome variables compared to an active comparison group?           Specific questions relating to the process of change:        4. Are therapeutic effects of the hybrid emotion-focused treatment mediated by changes in          proposed transdiagnostic emotion regulation process variables (worry, rumination,          cognitive and behavioral avoidance, emotional suppression)?   "
36476|NCT02808273|"     A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as     an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events     in microsurgicals free flaps during head and neck reconstruction.   "
36477|NCT02808260|"     Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that     are only detected by implanted pacemakers or defibrillators. Usually people don't know that     they have these episodes. Over time, these episodes can happen more often and last for longer     periods. In some people, the heart eventually remains permanently in a fast irregular rhythm,     known as atrial fibrillation. This condition can lead to strokes and blood clots. If     physicians could detect atrial fibrillation at a very early stage they could treat people     early and possibly prevent the condition from becoming permanent. People with implanted     devices allow a unique opportunity to constantly monitor the heart rhythm so investigators     can detect any irregularities immediately.      Investigators don't know which people are at risk of developing short episodes of fast     irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to     find out if there are proteins or chemical changes in the blood that can predict the risk of     developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be     able to give investigators other clues about atrial fibrillation.   "
36478|NCT02808247|"     This is a prospective, multicentric, randomized, open label Phase II trial investigating     whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic     compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after     failure of first line chemotherapy prolongs progression-free survival.      The primary objective of the trial is to evaluate whether nintedanib given as second-line     therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival     when compared with ifosfamide.      Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in     terms of progression-free survival rate at 12 weeks, overall survival, objective response     rate, patient benefit rate, response duration, total duration of treatment with nintedanib     safety, Health related Quality of Life and Health Economics.      Exploratory objectives include an analysis of putative predictive biomarkers for the     anti-tumor effects of the investigational agent nintedanib.treatment.   "
36479|NCT02808234|"     The study is a prospective non-randomized multi-center feasibility clinical trial to     establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody     fusion procedures.   "
36480|NCT02808221|"     Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can     be prevented by early action. The management of HF is complex: long, often difficult and     costly. In France, nearly one million people suffer from HF and 120,000 new cases are     diagnosed every year. With the aging population, this number will continue to evolve and     become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart     failure in either the 3 most common diseases in industrialized countries.      Investigators goals are to make an inventory of PRADO-IC project in terms of its     effectiveness on readmission of patients with heart failure.   "
36481|NCT02808208|"     The aim of this phase 1 study is to determine the role of autologous adipose derived     mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when     applied during the time of surgical creation.   "
36482|NCT02808195|"     The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb     motor rehabilitation system (ULMTS) program on motor performance and functional outcomes. The     specific aims of this study project will be:      To compare the effectiveness of intervention groups using Kinect-based ULMTS with     constraint-induced therapy on motor improvement in children with hemiplegic CP. The     investigators hypothesize that motor improvement in using Kinect-based ULMTS will be     comparable to constraint-induced therapy.   "
36762|NCT02804490|"     The purpose of this randomized control trial is to test the impact of provitamin A carotenoid     biofortified maize meal consumption on maternal and infant vitamin A status.   "
41114|NCT02747472|"     Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of     insulin secretion.   "
36483|NCT02808182|"     Lipotoxicity-causing fatty acid overexposure and accretion in lean tissues leads to insulin     resistance and impaired pancreatic β-cell function - the hallmarks of T2D - contributing to     associated complications such as heart failure, kidney failure and microvascular diseases.     Proper dietary fatty acid (DFA) storage in white adipose tissue (WAT) is now thought to     prevent lean-tissue lipotoxicity. Using novel Positron-Emission Tomography (PET) and stable     isotopic tracer methods which were developed in Sherbrooke, the investigator showed that WAT     storage of DFA is impaired in people with pre-diabetes or T2D. The investigator also showed     that this impairment is associated with greater cardiac DFA uptake, as well as subclinical     left-ventricular systolic and diastolic dysfunction. Then, It has been found that modest     weight loss in pre-diabetics, after a one-year lifestyle intervention, improved WAT DFA     storage, curbed cardiac DFA uptake, and restored associated left-ventricular dysfunction. It     has been also found that a 7-day low-saturated fat, low-calorie diet raised insulin     sensitivity but did not restore WAT or cardiac DFA metabolism. Whether WAT DFA storage     directly impacts cardiac DFA uptake is not known. Importantly, the investigator recently     uncovered marked sex-specific differences in WAT DFA metabolism. These may explain, at least     in part, sex-related differences in the cardiac DFA uptake, which occurs in pre-diabetes.     Higher spillover of WAT DFA into circulating Non-Esterified Fatty Acid (NEFA) appears to be     linked in women to greater cardiac DFA uptake, as opposed to direct cardiac chylomicron     triglycerides (TG) uptake in men. Here, the investigator will isolate and compare     organ-specific fatty acid uptake occurring postprandially from chylomicron-TG vs. NEFA pools,     as well as the oxidative vs. non-oxidative intracellular metabolic pathways associated with     increased cardiac DFA uptake in pre-diabetic men and women.   "
36484|NCT02808169|"     Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb     length evaluation during Anterior hip replacement as measured intraoperative with C-Arm     visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.   "
36485|NCT02808156|"     This 3-year research project aims to investigate and compare the immediate and long-term     treatment effectiveness as well as motor improving curve and potential predictors of the     unimanual intensive training and bimanual intensive training protocols with an equivalent     intervention period in children with hemiplegic CP and children with CP with apparently one     side affected. In addition, based on the ICF-CY model, comprehensive outcome measures     including motor functions as well as psychological functions will be included.   "
36486|NCT02808143|"     The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the     tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent     in patients with bladder tumors. Another purpose of the study is to see what tumor     characteristics are associated with increased efficacy of the pembrolizumab. Pembrolizumab     (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune     cells) designed to allow the body's immune system to work against tumor cells. Pembrolizumab     is Food and drug Administration (FDA) approved for the treatment of advanced melanoma (a type     of skin cancer) and some types of lung cancer. It is not yet approved by the United States     Food and Drug Administration (USFDA) for bladder cancer, hence it is considered an     investigational agent for this disease.   "
36487|NCT02808130|"     The investigators hypothesized that hyperlipidemia as an unfavourable levels of lipoprotein     subfractions have deleterious impact on the development of periodontal infection by altering     oxidative stres status of periodontal tissues. The aim of this study was therefore to     investigate i) effect of hyperlipidemia on oxidative change in GCF content, ie. MDA, PC and     TAOC levels in patients with different periodontal status,   "
36488|NCT02808117|"     This study will analyze data from a program run by an microfinance institution (MFI) in Haiti     from 2011-2012 where the MFI delivered health goods to some of the villages where it     operates. By comparing health indicators among children who were in villages targeted by the     program initially to children who were in villages that were not targeted by the program     until later, the investigators hope to understand if the MFI successfully delivered the     intervention and offer a practical platform for delivery of basic health goods.   "
36489|NCT02808104|"     The purpose of this study is to determine whether a controlled release formulation of     mazindol is more effective than a placebo in the treatment of Attention Hyperactivity     Disorder (ADHD) in adults.   "
36490|NCT02808091|"     -  Assess responses, progression free survival (PFS) and overall survival (OS) of the          combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in          Stage IB or bulky disease - II and without IMRT in Stage III - IV.        -  Assess the toxicity and maximum tolerated dose of bortezomib administered in combination          with GIFOX chemotherapy.   "
36491|NCT02808078|"     The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority     randomized control trial in neurorehabilitation. The main objective is to test whether a 4     weeks gait rehabilitation program that uses augmented reality is superior to a conventional     treadmill training program of equivalent intensity. Baseline assessments precede allocation,     which consists in blocking randomization (2:1 ratio) with stratification according to the     disease etiology. Post-intervention assessments serve to compare the short-term efficacy of     the intervention between the two groups. Three months after discharge, follow-up assessments     take place to detect potential long-term effects.   "
36492|NCT02808065|"     Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was     developed through clinical trial with healthy volunteer. The purpose of this study is to     confirm predictability of developed pharmacokinetic model in kidney transplant recipients.   "
36493|NCT02808052|"     This is a Phase 1, open-label, single-dose study of the safety, tolerability, and     pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal     insufficiency.   "
36494|NCT02808039|"     to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a     hyperreactive phase of platelet function   "
36495|NCT02808026|"     To examine antihypertensive effect and safety of administration of CS-3150 in patients with     severe hypertension (Grade III).   "
36496|NCT02808013|"     Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the     efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with moderate     to severe lower urinary tract symptoms (LUTS)   "
36508|NCT02807857|"     This low interventional study, whose unique intervention will be to measure the blood level     of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by     Primary Care Physicians (PCPs) in Europe, will assess if the cardiologist referral guided by     NT-proBNP measurement in patients who are currently judged by PCPs as being stable, will lead     to optimization of HF treatment, defined in adherence to treatment recommendations of the     current European Society of Cardiology guidelines for the treatment of heart failure.   "
36497|NCT02808000|"     This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating     safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of     both latex and silicone. The included patients are permanently catheterized spinal cord     injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden.      Primary Outcome Measures:      • The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley     catheters, compared to the use of standard catheters for the same time period, on re-current     symptomatic catheter associated urinary tract infection (CAUTIs).      Secondary Outcome Measures:      • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria,     bacteremia, urosepsis and ICU stay.      Exploratory Outcome Measures:      • assessment of levels of immunological markers in urine, urinary bacterial type and     resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the     catheter surface after use.   "
36498|NCT02807987|"     To examine antihypertensive effect and safety of administration of CS-3150 in combination     with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.   "
36499|NCT02807974|"     To examine antihypertensive effect and safety of administration of CS-3150 in combination     with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.   "
36501|NCT02807948|"     This study is a prospective, non-randomized, multi-center study of subjects implanted with an     SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization     therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.   "
36502|NCT02807935|"     The purpose of our current series of studies is to evaluate different glaucoma treatments in     vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC)     anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images     will be taken as part of the patients routine medical follow up (before starting the     treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be     measured using commercially available 3-dimensional reconstruction.      The series of studies will be divided into 3 branches, each branch contains different     treatments.For each treatment different patients will be recruited.      The branches are as following-        1. The surgical branch-             1. Before and after trabeculotomy             2. Before and after cataract surgery             3. Before and after vitrectomy surgery             4. Before and after XEN™ Gel Stent implant        2. The pharmacological branch-             1. Before and during the treatment with prostaglandins analogs             2. Before and during the treatment with alpha blockers             3. Before and during the treatment with beta blockers             4. Before and during the treatment with carbonic anhydrase inhibitor        3. The laser branch-             1. Before and after trabeculoplasty             2. Before and after laser iridotomy             3. Before and after yag capsulotomy laser   "
36503|NCT02807922|"     Sleep disturbance is frequent in patients with advanced cancer and decreases the tolerability     of other symptoms and impairs quality of life. A detailed description of sleep disturbance     and its association with other symptoms, and intervention studies on sleep medications are     scarce in patients with advanced cancer. A well-designed randomized controlled trial is     needed to determine the short time effectiveness of zopiclone on sleep quality, one of the     currently available therapies of insomnia, and further to contribute to the clinical     management of insomnia in patients with advanced cancer.   "
36504|NCT02807909|"     The study is being conducted to assess the effects of co-administration of itraconazole or     diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T)     of BMS-986177   "
36505|NCT02807896|"     Multiple biomarker development through validation of useful markers generated by next     generation bio-data based genome research and cohort study   "
36506|NCT02807883|"     You are being asked to take part in this study because you either had Ph positive B-lineage     acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently     received an allogeneic stem cell transplant (cells from someone else).      The goal of this clinical research study is to learn if blinatumomab in patients who have had     an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in     patients who either have a small amount of ALL or have had ALL in the past. The safety of     this drug will also be studied.   "
36507|NCT02807870|"     Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent     mental disorders in children and is associated with important negative functional outcomes     throughout development. The first signs and symptoms become apparent in preschool age.     Therefore, early interventions in this population have the potential of limiting the     disorder's negative impact and preventing future impairments in affected individuals. The     first-choice medication for treating ADHD is methylphenidate, which has evidence of efficacy     and safety in preschool children. However, non-evidence based worries and pressure from the     media placed parent training as the first-line treatment for ADHD in clinical guidelines.     Parent training is a behavioral intervention implemented with the parents, with weekly     sessions for 8 weeks, adequate for treating ADHD dysfunctional symptoms and behaviors.     However, the level of evidence for this intervention is reduced. Furthermore, the need of     trained therapists in the public health system, added to the difficulties on adherence and     comprehension from parents, limit its generalization and raise questions regarding its     indications. Until now, no study has compared pharmacological treatment with methylphenidate     to parent training in preschool children with ADHD regarding their clinical efficacy and     cost-effectiveness. Moreover, no study has evaluated the impact of pharmacological     intervention and psychotherapy on neurobiological mechanisms of ADHD, which is crucial for     determining their impact on neurodevelopment.      Objectives: This is a double-blind randomized clinical trial that aims to evaluate the     efficacy, tolerability and acceptability of treatment with methylphenidate compared to     parental training and placebo in preschool children with ADHD. Furthermore, the investigators     propose the use of advanced neuroimaging techniques for the assessment of changes in brain     connectivity from the institution of treatment.      Methods: This study will be a randomized, double-blind, parallel-group, evaluating two active     interventions and placebo control group. One hundred and fifty children aged 3 years and 11     months and 5 years and 11 months, diagnosed with ADHD, will be randomized to receive     treatment with methylphenidate and information (50 children), parental training and treatment     with placebo medication (50 children) or belong to active control group with educational     information for parents and placebo treatment with no treatment (active control, 50     children). The treatment will last eight weeks, the neurobiological outcomes will be assessed     before and after treatment and clinical outcomes will be assessed at weeks 0, 5 and 9 will     also be evaluated 50 children with typical development in relation to neurobiological     measures.      Implications: This study proposes an innovative and relevant analysis, which will enable the     field to advance the knowledge of biological mechanisms related to ADHD and to treatment     response. Also, the study will expand the evidence to guide early prevention strategies and     early intervention.   "
36509|NCT02807844|"     The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability,     pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of     MCS110 with PDR001 in adult patients with solid tumors.   "
36752|NCT02804620|"     This study is a 12-month study. There are two different groups in the study. Both groups will     enter the study after the graduation from 8-hour diabetes education course taught at VGH, St.     Paul's, or Richmond Hospital. The first group will receive on-going support from their peers     who have diabetes and are trained specifically to help other patients with diabetes. The     second group will receive the usual care.   "
36510|NCT02807831|"     Background: environmental influences in the first years of life have a great impact on     adulthood. Adequate environmental stimulation in the first years of life positively influence     cognitive, emotional and neurological development. Studies show that high quality education     for 3 to 6 years old children are cost-effective for diverse outcomes, such as socioemotional     and cognitive development, as well as school performance. However, it is not clear why     specific types of interventions are most effective on school readiness, an important     precursor of literacy status and later life outcomes. Objectives: adapt to the Brazilian     context two well-known intervention programs: (1) executive functions training developed by     Diamond, and (2) oral language skills based on the Nuffield Programme developed by Snowling     and colleagues. Methods: a randomized controlled trial involving 720 children (4 to 5 years     old) allocated to three groups: (1) adapted school curriculum focusing on executive functions     training, (2) adapted school curriculum focusing on oral language skills training, and (3)     regular school curriculum.   "
36511|NCT02807818|"     Home visiting programs for pregnant women aiming to improve mother-infant relationship has     received worldwide attention in the past 30 years. These programs are considered an important     strategy to improve women's health during pregnancy, aside from improving child's birthing     conditions and allowing parents access to tools which will nurture and properly stimulate     their baby, thus promoting emotional and cognitive development. Objectives: The Nurse home     visitation program for pregnant youth aims to promote infant´s healthy development, from     pregnancy to the first months of life, in a high-risk population. Methods: Eighty young     pregnant women aged between 14 and 20 years were randomly allocated to the intervention or to     usual prenatal care program. The Nurse home visitation program for pregnant youth was     developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s     bioecological model, which recognizes the importance of individual and family inclusion in     various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of     attachment, which involves the care practitioner addressing issues such as environmental     health, life course and parenting, bond between mother and infant, and infant´s social and     cognitive development. Neuropsychomotor development will be assessed at 3, 6 and 12 months     using the Bayley Scale of Infant Development. Brain development will be assessed via     electroencephalography at 6 and 12 months.   "
36512|NCT02807805|"     This phase II trial studies the side effects and how well abiraterone acetate, niclosamide,     and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens     can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight     prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that     may block another signal that can cause prostate cancer cell growth. Prednisone is a drug     that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone     may be a better treatment for patients with hormone-resistant prostate cancer.   "
36513|NCT02807792|"     This protocol will test a new prototype of a peri-anal access device, with increased flexible     length and a captured operative field, for feasibility in patients immediately prior to their     scheduled peri-anal procedure.   "
36514|NCT02807779|"     This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular     healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an     endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the     leg.   "
36515|NCT02807766|"     Autism is a well-recognized neurodevelopmental disorder severely affecting the health of     children. While the unclear neurobiological basis of autism and the lack of effective     medication, the most commonly used approach for treatment is behavioral intervention.     However, the pathophysiological mechanisms underlying the intervention therapy remains     incompletely understood. The current project aims to explore the impacts of different early     behavioral intervention methods on brain plasticity of autism using multimodal MRI technique     and provide guidelines for the intervention and treatment of autism by evaluating the     efficiency of these methods.   "
36516|NCT02807753|"     To evaluate the prevalence of subclinical arthropathy in children with severe hemophilia     undergoing a prophylaxis regimen and without evidence of target joints, using a validated     ultrasound scoring method.   "
36517|NCT02807740|"     Patients affected by Parkinson disease (PD) can benefit from rehabilitation although the     evidences are scattered. In the last years there are increased evidences that virtual reality     can improve functional outcome in Parkinson's disease. No evidences are known concerning the     cardiological safety and effect on balance of Virtual Reality. The aim of this study is to     compare a virtual reality rehabilitation program versus a conventional one in a sample of     patients affected by mild to moderate Parkinson and to collect data on cardiological effects.   "
36518|NCT02807727|"     This study will evaluate the benefit of Intralipid® or placebo administered prior to     reperfusion to limit ischemia reperfusion injury as measured by the geometric mean difference     of the release of troponin I over 72 hours after coronary artery bypass.   "
36519|NCT02807714|"     The purpose of this study is to find an association between a protein named Podocan and WNT     pathway regulatory molecules in patients with different forms of Coronary Artery Disease     (Acute Coronary syndrome, Stable Angina and Coronary Artery Restenosis). It has been found in     experimental studies that this protein is regulating smooth muscle cell function and hence     may be influencing the progression of Coronary Artery Disease (CAD). We are testing to see if     the same regulatory function exists in human subjects. Studying patient's blood will possibly     enable to identify an association between Podocan and CAD. This may help to better prevent     and treat CAD with improved understanding of the mechanism of the disease. No drugs or other     therapeutic interventions will be used for the purpose of the research study. Only blood     samples will be collected in the cardiac catheterization lab. As a part of this study     participants will be followed for repeat events or repeat cardiac catheterization over a     period of 24 months.   "
36548|NCT02807337|"     Prospective double-blinded randomized clinical study. Aim of the study is to compare the     effectiveness of Caphosol mouth rinses in prevention of oral mucositis as compared to 0.9%     NaCl rinses. Patients will be randomized to receive either Caphosol or 0.9% NaCl rinses four     times a day for seven days from the beginning of chemotherapeutic regimen. The same patient     will be given the opposite rinse during the next chemotherapeutic regimen, so everyone will     get both mouth rinses once during the trial.   "
36520|NCT02807701|"     Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary     and pancreatic diseases including malignant and benign conditions. The outcome of PD has     improved over the last two decades due to advances in surgical techniques, anesthesia and     perioperative care. Although studies from high volume centers demonstrate reduce in the     operative mortality to less than 3%, the postoperative morbidity rate is still ranging from     30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to     traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy     (LPD) is a difficult procedure that has become increasingly popular. Nevertheless,     comparative data on outcomes remain limited. In this prospective randomized study,     investigators evaluate the safety and feasibility of surgical and oncological outcomes of     minimally invasive PD compared to conventional open PD.   "
36521|NCT02807688|"     The study evaluates the efficacy of health promotion strategies on diet and physical activity     in patients with psychosis. Half of the participants will receive an intervention protocol     based on education and behavioural change, while half will not receive it.   "
36522|NCT02807675|"     This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to     evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily     dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's     disease (PD).   "
36523|NCT02807662|"     The objectives of this research study are to screen 750 pregnant women at risk of     trauma-related stress symptoms, and adapt and test an evidence-based intervention for     pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community     health centers.   "
36524|NCT02807649|"     To evaluate the efficacy of Nutrilite® ginkgo biloba cistanche tablets in relieving the     symptoms of chronic fatigue syndrome(CFS), the investigators randomly recruit189 subjects     with CFS, aged 35-60 yrs. The relief of fatigue and improvement of sexual function are     evaluated by World Health Organization Quality Of Life Brief (WHOQoL-Bref), Sexual Life     Quality Questionnaire (SLQQ), chronic fatigue syndrome, symptoms of self-assessment at the     baseline and the end of intervention. Subjects also underwent a blood test measuring the     concentration of biochemical indicators. Cistanche is mainly used to strengthen the renal     function, nourish essence and blood in the treatment of lumbar debility, impotence,     infertility and muscles weakness, constipation. etc. The study is to test the hypothesis that     consecutive 60-day intake of the study tablets can relieve the symptoms of CFS; according to     the change of blood biology indicators, the investigators will also evaluate the association     between the change of plasma outcome measures and chronic fatigue syndrome.   "
36525|NCT02807636|"     A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy     versus chemotherapy alone in participants with untreated advanced urothelial cancer.   "
36526|NCT02807623|"     The purpose of this clinical investigation is to evaluate the efficacy and immunologic     effects of a non-pharmacological exercise intervention (pushups) compared to an oral NSAID     (ibuprofen) and an oral placebo to decrease local injection site inflammation symptoms of     delayed pain, erythema, and edema and any impact on serologic antibody immune response after     influenza vaccine receipt.   "
36527|NCT02807610|"     The ideal induction agent for day care surgery should have properties of rapid, smooth     induction, better haemodynamic profile, faster recovery and devoid of side effects in the     form of pain on injection, involuntary movements, respiratory depression and post-operative     nausea/vomiting. Propofol is the drug being used for day care surgeries because of its rapid,     smooth induction and faster recovery. But its use is associated with pain on injection (even     with added lidocaine), hypotension and respiratory depression. So the need for an agent with     better hemodynamic control and lesser side effects was felt. The introduction of etomidate     lipuro revolutionised the anaesthesia practice. It possesses many of the properties of an     ideal induction agent. This newer formulation of etomidate in lipid emulsion i.e. etomidate     lipuro is known to have rapid, smooth induction, haemodynamic stability and lesser side     effects than older etomidate with propylene glycol (hypnomidate).      Hence, investigators devised a prospective randomized controlled open trial and compared this     newer lipid formulation of etomidate with propofol in terms of - induction time, haemodynamic     parameters and side effect profile.   "
36528|NCT02807597|"     The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided     tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study,     the investigators will conduct intraoperative imaging procedures that have minimal     interference with ongoing surgery. The underlying hypothesis is that the accurate detection     of all cancer cells highlighted by LS301 during surgery will reduce the number of breast     cancer patients with margin positivity to less than 5%, compared to the current surgical     paradigm of greater than 20%. The pilot study will obtain critical data required to address     the larger question of surgical margin assessment in a full Phase I clinical trial.   "
36529|NCT02807584|"     This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative     to traditional wound care methods.      Patients will be treated with ELECT for 14 days. Data relating to wound healing, the     performance of the dressing and the opinion of the doctor will be collected.      The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose'     and will be effective at treating a variety of wounds.   "
36530|NCT02807571|"     This study is aimed at determining if office based surgery is an effective way of cutting     health care cost while maintaining patient safety and satisfaction.   "
36531|NCT02807558|"     The purpose of this study is to determine the activity of SY-1425 in relapsed/refractory     acute myeloid leukemia (AML) patients, relapsed/refractory higher-risk myelodysplastic     syndrome (MDS) patients, newly diagnosed treatment naïve AML patients who are unlikely to     tolerate standard intensive chemotherapy (SY-1425 administered as a monotherapy or in     combination with azacitidine), or lower-risk myelodysplastic syndrome (MDS) patients who are     positive for a RARA biomarker.   "
36570|NCT02807051|"     This will be an open-label, single-center, crossover, one-way, drug-interaction study to     evaluate the effect of 500 mg clarithromycin BID (dosed to steady state) on the PK of a     single 400-mg dose of pacritinib in healthy male and female subjects.   "
36571|NCT02807038|"     A single group of pregnant women who was analyzed in the first and in the third trimesters of     pregnancy   "
36534|NCT02807519|"     Oral complications during and after cancer treatment are common. A key role in maintaining     oral health plays saliva. In the last decade numerous studies have investigated immunological     biomarkers such as cytokines in saliva samples. In children, the few studies have     investigated salivary cytokines (sCK) suggesting that these are associated with oral health     (sCK). One study investigating sCK in adult oncology patients showed an association between     Interleukin-6 (IL-6) and severity of oral chronic graft-versus-host disease (GVHD) in     survivors of hematopoietic stem cell transplantation. Therefore determination of sCK     concentrations may also be helpful for assessment of GVHD activity and other inflammatory     processes in cancer patients. In pediatric oncology patients, to the investigators'     knowledge, no study has so far investigated sCK concentrations as markers for oral or     systemic health.   "
36535|NCT02807506|"     This project develops and tests the use of service robots to track health of the elderly over     time. The objectives are to develop a low-cost mobile manipulator capable of a limited set of     elder- relevant manipulation tasks (e.g. picking up dropped items). The investigators will     visualize and model the use of the service robot during deployments at an elder care     facility. Feedback from focus groups with elders and clinicians will inform the necessary     engineering innovation.   "
36536|NCT02807493|"     The primary objectives of this study are to determine if the use of an Occlusal Support     Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor,     reduce the incidence of labor complications including Caesarian Sections and improve Apgar     scores in newborns   "
36537|NCT02807480|"     This project aims to identify brain and behavioral characteristics of individuals     experiencing symptoms of generalized anxiety disorder that will predict the effectiveness of     Exposure-based therapy versus Behavioral Activation Therapy. Brain imaging aspects of the     study will use functional magnetic resonance imaging (fMRI) and electroencephalography (EEG).     Behavioral assessments will include self-report questionnaires, computer-based and     observational tasks, and interviews. Assessments will focus on how individuals process     positive information (such as reward) and negative information (such as distressing images),     as well as how people make decisions. These assessments will be conducted across 2-3     in-person sessions prior to beginning the treatment, and will be repeated across 2-3     in-person sessions after completing treatment. A blood draw will also be conducted pre- and     post- treatment. Both the Exposure-based and Behavior Activation therapy will consist of 10,     90-minute weekly therapy sessions conducted in small groups.   "
36538|NCT02807467|"     In this randomized study, the investigators aim to test the hypothesis that the reinstitution     of a normal circadian rhythm by continuous infusions of dexmedetomidine compared to propofol     between 8pm and 6am after diagnosis of hyperactive or mixed delirium, decreases the duration     of delirium. The infusions might have to be repeated several times to achieve resolution of     delirium.   "
36539|NCT02807454|"     This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab +     daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will     also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to     durvalumab + daratumumab (PD3).   "
36540|NCT02807441|"     The investigators would like to further the current understanding of aspirin and its effects     on perioperative bleeding by conducting a randomized controlled trial of spinal surgery     patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators     hypothesize that there will be no significant difference in perioperative blood loss between     the different groups.   "
36541|NCT02807428|"     The objectives of this study are to evaluate the safety and analgesic efficacy of a single     preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral     total knee arthroplasty.   "
36542|NCT02807415|"     The academic investigator - initiated trial will evaluate in a postapproval setting whether,     and if yes, to what extent and variability, the treatment with lumacaftor in combination with     ivacaftor reverses the p.Phe508del CFTR - mediated basic defect in p.Phe508del homozygous     subjects with cystic fibrosis under real life conditions.   "
36543|NCT02807402|"     This study seeks to provide evidence of the effectiveness and obtain patient reported outcome     (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic     hepatitis C (CHC) in a real life setting across clinical practice patient populations in     Romania   "
36544|NCT02807389|"     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer     using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of 20     million cells. 15 adult patients (age 18 and greater) with persistent symptomatic     post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic     therapies will be enrolled. The subjects will be subsequently followed for fistula response     and closure for 18 months. This is an autologous product derived from the patient and used     only for the same patient.   "
36545|NCT02807376|"     This prospective, randomized, controlled, multi-center study will collect and compare data     from the surgeon's current standard of care stapler (for renal artery and renal vein     transection) and powered vascular stapler   "
36546|NCT02807363|"     This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide     evaluation of the PK/PD metrics of two different oral doses selected upon the results of the     study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens. The     PK/PD profiles of the study drug will be compared to the leuprolide formulation approved for     the treatment of endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg).     Major PK (e.g., a total exposure to leuprolide) and PD parameters (e.g., rates of the     estradiol suppression and cessation of the menstrual period) will also be evaluated against     the Lupron Depot historical data.   "
36547|NCT02807350|"     The main objectives of this randomized trial comparing overminus lens treatment to     non-overminus (spectacles without overminus or spectacles with plano lenses) are to     determine:        -  The long-term on-treatment effect of overminus treatment on distance intermittent          exotropia (IXT) control score.        -  The off-treatment effect of overminus treatment on distance IXT control score (following          weaning and 3 months off treatment).   "
36592|NCT02806765|"     The purpose of this study is to determine whether specific nutrient supplementation can     improve dynamic stability in older adults.   "
36549|NCT02807324|"     Pregnancy is considered a cardiovascular (CV) stress test, and complicated pregnancies are     associated with an increased risk for cardiovascular disease (CVD) later in life. Moreover,     it is known that often the pregnancy induced CV adaptation does not resolve completely after     a short postpartum (PP) period and it is not clear whether these induced changes will resolve     over a longer period of time (i.e. in the upcoming months/years after delivery).     Understanding the cardiac adaptation during pregnancy and the reversal process in the     postpartum period, as well as the factors that influence this these processes, may provide us     not only insight in this mechanism, but may help us in identifying factors that may be target     points for modification.   "
36550|NCT02807311|"     Undernutrition is the result of energy and protein deficiency and / or catabolic. These     phenomena are observed daily in patients awaiting lung transplantation.      After lung transplantation that undernutrition is growing (on average 11% weight loss after     the first observations in the continuing care of the University Hospital of Strasbourg). In     other words the non-malnourished patients become. Hence the importance to reach every patient     awaiting transplant, mainly to patients already malnourished before surgery.      Several studies have shown that early nutritional support has a direct effect on reducing     comorbidities and the average length of stay. In the course of care of these patients it is     necessary to intensify the dietary management to give them the best chance for early     rehabilitation.      The main objective of the study is to evaluate the impact of the use of the SFNEP's     nutritional care decision-making tree (Société Francophone Nutrition Clinique et Métabolisme)     on the implementation of enteral nutrition by gastrostomy tube in patients awaiting for lung     transplantation.   "
36551|NCT02807298|"     This study compared the anesthetic efficacy between Lignocaine and articaine administering it     intraligamentarly using ligajet in twenty five female patients having irreversible pulpitis     on bilateral mandibular molars. At 5minutes of post injection, the teeth were isolated with     rubber dam and access performed. Patients were instructed to definitively rate any pain felt     during endodontic procedure. If patient felt pain, the treatment was immediately stopped and     the patient rated their discomfort using Heft Parker VAS. The extent of access achieved when     the patient felt pain was recorded as within dentin, entering the pulp chamber or initial     file placement. The success was defined as the ability to access and instrument the tooth     without pain (VAS score of zero) or mild pain (VAS rating<54mm).   "
36552|NCT02807285|"     The primary objective of this expanded access program is to provide ocrelizumab as treatment     for eligible participants with primary progressive multiple sclerosis (PPMS) before it is     commercially available in the United States (U.S.) for the indication of PPMS.   "
36553|NCT02807272|"     A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR)     of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive     tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7     and 15-21) in 28 day cycles. In the absence of unmanageable toxicities, subjects may continue     to receive tipifarnib treatment until disease progression. If a complete response is     observed, therapy with tipifarnib will be maintained for at least 6 months beyond the start     of response.   "
36555|NCT02807246|"     This study was designed as a prospective controlled study to investigate the effects of     probiotic support started immediately after birth on newborn jaundice in breastfed babies     born by normal spontaneous vaginal delivery.   "
36556|NCT02807233|"     The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide     Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with     acromegaly in daily clinical practice.   "
36557|NCT02807220|"     The objective of this study is to evaluate the efficacy and safety of Imuneks 10 mg Capsules     in the prophylaxis of cold and the maintenance of the good health state in 70 healthy     subjects.   "
36558|NCT02807207|"     The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of     pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF)     interval in healthy subjects.   "
36559|NCT02807194|"     Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in     surgery for lumbar disc herniation.   "
36560|NCT02807181|"     The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT)     using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment     (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic     cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus     SIRT, and half of the patients will be randomized to CIS-GEM alone.   "
45058|NCT02695888|"     This research study examines the feasibility of using an in-vehicle mobile technology     monitoring system to measure teen secondary task engagement during on-road driving as the     outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.   "
36561|NCT02807168|"     Acute decompensated heart failure (ADHF) is a health problem of great magnitude, because it     is the most frequent cause of hospitalization of patients over 65 years old. Of these     patients, more than 50% will be readmitted within the next six months with the consequent     worsening prognosis, increased mortality and high costs associated. In fact, two-third parts     of the costs of this condition are due to hospitalizations. Hence the increased importance of     ADHF and its associated hospitalizations as an essential event in the natural history of the     disease on to address therapeutic efforts.      However, at the present time there is a change of scenario that makes that more than half of     these patients show HF with preserved ejection fraction (PEF), so that acute heart failure     with preserved ejection fraction (AHF-PEF) is a fact with high prevalence and epidemiological     relevance. To this the investigators must add that, unlike patients with depressed EF, HF-PEF     has no therapeutic strategies that may have proven a recovery of the affected patients. All     this makes that overall heart failure with PEF and AHF-PEF represent a major health problem.      However, despite of the lack of effective treatments, there are also opportunities for     improvement both in terms of morbidity and mortality that should be evaluated. Rather than     looking for therapies or new specific drugs, these opportunities may be in the use of     management strategies among which the use of biomarkers and their monitoring could be key. In     this regard, NT-proBNP has been shown to correlate with severity and prognosis, including the     risk of decompensation. Nevertheless, whilst the latest guidelines for heart failure     management recommend its use in the diagnosis of HF, the use of biomarkers to monitor and     guide treatment has not been included yet.      The assumption of this study is that the use of NT-proBNP may serve as a therapeutic and     management guideline for the in-patient with HF-PEF who is to be discharged, allowing a     reduction of decompensations and hospitalizations as well as a better functional situation at     6 months.      Several criteria have been proposed to define the syndrome of HFpEF according to the 2013     ACCF/AHA Heart Failure Guideline including (a) clinical signs or symptoms of HF; (b) evidence     of preserved or normal LVEF; and (c) evidence of abnormal LV diastolic dysfunction that can     be determined by Doppler echocardiography or cardiac catheterization The assay N‑terminal     proB‑type natriuretic peptid is indicated as an aid in the diagnosis of individuals suspected     of having congestive heart failure and detection of mild forms of cardiac dysfunction. The     test also aids in the assessment of heart failure severity in patients diagnosed with     congestive heart failure. This assay is further indicated for the risk stratification of     patients with acute coronary syndrome and congestive heart failure, and it can also be used     for monitoring the treatment in patients with left ventricular dysfunction.   "
36562|NCT02807155|"     In Los Angeles County, the most populous county in the United States, there are an estimated     8,000 children under the age of 21 with type 1 diabetes. Although provisions for pediatric     care exist, once these children become young adults they age out of their health care     services. There is no formal transitional care program to help these individuals through this     process of changing health plans and many end up without adequate care. This project aims to     develop and implement a transition care program for young adults with type 1 diabetes in     order to ensure uninterrupted transition from pediatric to adult diabetes health care and     improve health and psychological outcomes.   "
36563|NCT02807142|"     The objective of the study is to determine if the cell therapy NC1 administered in the spinal     cord is effective for the treatment of a post-traumatic syringomyelia. The post-traumatic     syringomyelia is the development and progression of cyst filled with cerebrospinal fluid     (CSF) within the spinal cord. The cell therapy NC1 consist on cells obtained from the bone     marrow of the patient, that are cultured in vitro and administered in the spinal cord of the     same patient.   "
36564|NCT02807129|"     The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The     elderly population is very heterogeneous, it is necessary to evaluate these elderly patients     before treatment to assess the risk-benefit balance. To date, this assessment relies on     subjective clinical methods often not optimal, and slow to implement. An innovative method of     evaluation could be the determination of elastin peptides. Indeed, the rate of these     peptides, which are linked to serious conditions associated with age, rising inexorably with     age and dose could help determine more objectively the type of treatment to offer older     patients.      Expected results : This study will allow better identification of the group of frail elderly     through more relevant biological marker that clinical assessment, often subjective and not     available within a period compatible with the treatment of newly diagnosed cancer. This     biological assessment will also enable optimal management of elderly patients in particular     by allowing the geriatrician better efficiency.   "
36565|NCT02807116|"     The primary objective is to evaluate the effect of rifampin, a potent cytochrome P450 3A4     inducer, at steady-state on the systemic exposure of a single dose of pacritinib in healthy     subjects.   "
36566|NCT02807103|"     Phase III, comparative, multicenter, randomized, controlled, double-blind and superiority     research, comparing rituximab-based regimen with conventional therapeutic strategy for the     induction of remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA).      Patients with newly diagnosed or relapsing EGPA will be randomized in a 1:1 ratio to receive:        -  Experimental therapeutic strategy based on the use of rituximab (experimental group)        -  Conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease          severity (comparative group)   "
36567|NCT02807090|"     Supervised exercises are the first line therapy for patients with chronic low back pain. The     lumbar segmental stabilization (LSE) is a specific training for the muscles of the lumbar     spine, which aims to improve neuromuscular control, strength and endurance of the muscles     that promotes stability to the spine. The circular dance (CD) belongs to the group of     complementary and integrative practices entered in Public Health Care in Brazil, and has been     used to improve several aspects related to physical and mental states such as flexibility,     posture, strength and muscular endurance, awareness or scheme body, pain control and strains.     There are few studies evaluating the circular dance effect on back pain. The aim of this     study is to compare the effects of lumbar stabilization exercises and circular dance for     improvement in non specific low back pain in middle-aged women.   "
36568|NCT02807077|"     This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg     dose of pacritinib will be administered orally to patients with renal impairment (mild,     moderate, severe, and patients with ESRD requiring hemodialysis) and sex-, age- and     weight-matched healthy subjects.Patients with ESRD will receive a single 400 mg dose of     pacritinib during 2 different treatment periods: Dialysis and Inter-Dialysis. The primary     objective of the study is to evaluate the pharmacokinetics and safety of pacritinib in renal     impairment.   "
36569|NCT02807064|"     This study is aimed at assessing the efficacy of supplementation with a mixture of three     bifidobacteria , on the allergic rhinitis..The rhinitis symptoms were assessed by validated     score ( TSS ) , for children aged between 4 and 17 years with allergic rhinitis parietaria ,     mild , moderate or severe , than children not supplemented .      Secondary Objectives        -  The effectiveness of treatment by VAS :        -  Evaluation of the rescue medication consumption        -  Evaluation of quality of life ( using structured questionnaire )        -  Evaluation of the frequency and school performance ( using structured questionnaire )        -  Assessment of sleep quality and attention (through structured questionnaire )        -  Satisfaction rating and satisfaction of parents        -  Evaluation of asthma exacerbations in children susceptible   "
36572|NCT02807025|"     Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary     fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and COPD. Similar sampling from healthy     controls for comparative data.      Aim: To characterise the molecular basis of the upper and lower airway mucosa inflammatory     response in different respiratory diseases. To assess molecular biomarkers and signatures to     see if these can aid diagnosis, stratification of these respiratory diseases. To direct     personalised medicine and rationalise therapy.      Outcome measures:Measurement of levels of inflammation, coagulation, complement activation     and fibrosis in MLF, transcriptomics from nasal curettage and airway brushings and to assess     the tolerability of absorption procedures in these patients.   "
36596|NCT02806700|"     Twitter use is surprisingly well represented across broad demographic population segments and     health-related messages. The promise of using Twitter is that its use is growing rapidly, it     allows the investigators to view communications that were impossible to intercept before, and     it potentially provides information faster and less expensively than collection from other     media channels. Prior work also supports that social media interventions can improve health     behavior change (e.g. weight loss, physical activity) and outcomes.The overarching goals of     this proposal are to understand the uses and limitations of this communication channel to     improve patients' ability to manage their CV health condition.   "
37242|NCT02798185|"     This is a study to develop methods of diagnosing chronic traumatic encephalopathy (CTE)     during life, as well as to examine possible risk factors for this neurodegenerative disease.     One component of this study is the use of an investigational PET scan radio tracer to detect     abnormal tau protein in the brain.   "
36573|NCT02807012|"     Associated with the worsening of functional capacity of older adult and the lack of guidance     on how to care of them after stroke, the family caregiver starts to fell burden related to     the care, and the quality of life was affected by that burden. Besides that, the older adult     began to use more frequently health services and had more hospitalizations by preventable     conditionals with adequate care.      The aim of this study is to evaluate the effectiveness of educational interventions of care     at home provide by nurses to family caregivers of older adult with stroke after hospital     discharge, compared with usual care guidelines or no guidance, in one month follow up. The     family caregivers of older adults post stroke with the first functional sequel from the     Clinical Hospital of Porto Alegre (HCPA) will participate in the study.      The intervention will involve the systematic monitoring of nurses through home visits (HVs)     during one month. Thus, will instrumentalize the family caregiver to care of older adult with     stoke according the protocol developed in a research group and the needs of care of them. The     control group won't receive the home visits and could have or not the usual care guidelines     provide by health services that have access.   "
36574|NCT02806999|"     Berberine is a conventional component in Chinese medicine. In recent years, effects of     Berberine on improvement of glucose metabolism have been explored. The purpose of this study     is to observe the therapeutic effects of combination of insulin and berberine on stress     hyperglycemia in patients after cardiac surgery.   "
36575|NCT02806986|"     Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects     and 20 pediatric subjects treated with subcutaneously administered IGSC 20% who complete the     entire study. This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC     20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20%     weekly doses). A total of 52 doses of IGSC 20% will be administered with a final follow-up     visit 1 week after the last dose at Week 53. Subjects/caregivers will be trained on     self-administration of IGSC 20% by the clinical site personnel.   "
36576|NCT02806973|"     This study will investigate how the body processes LY900018 and the effect of LY900018 on the     body. The study drug will be delivered into the participant's nostril(s) (intranasally) once     or twice in each of four study periods. The study is expected to last about 50 days for each     participant. The study is open to adults with type 1 or type 2 diabetes and will last about     50 days.   "
36577|NCT02806960|"     This study will investigate how the body processes LY900018 and the effect of LY900018 on the     body. The study drug will be delivered into the participant's nostril(s) (intranasally) once     or twice in each of four study periods. The study is open to adults with type 1 or type 2     diabetes and is expected to last about 50 days for each participant.   "
36579|NCT02806934|"     Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro     fertilization (IVF) in women without female infertility factor ?   "
36580|NCT02806921|"     The purpose of this study is to investigate changes in the level of inflammatory mediators in     the tear film of scleral contact lens wearers in a keratoconic population.   "
36581|NCT02806908|"     This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the     effect of JZP-110 on driving performance in subjects with excessive sleepiness due to     narcolepsy.   "
36582|NCT02806895|"     This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the     effect of JZP-110 on driving performance in subjects with excessive sleepiness due to     obstructive sleep apnea.   "
36583|NCT02806882|"     Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in     methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus     Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on     pneumococci resistant in penicillin and/or 3rd generation of cephalosporins.      Ceftaroline was approved by the European Medicines Agency for the treatment of complicated     skin and soft tissue infections and community-acquired pneumonia.      Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis.      Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with     gram-negative Bacilli.      The rationale of this study is based on the antibacterial spectra of ceftaroline that could     be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated     infections.      To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in     meningeal compartment after treatment.   "
36593|NCT02806752|"     The purpose of this study is to evaluate the effects and safety of ranibizumab therapy     combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal     vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes     polymorphism in response to the treatments. To further confirm the role of inflammatory     factors in the pathogenesis and advance of PCV.   "
36594|NCT02806739|"     The purpose of this study is to assess the feasibility of randomizing pregnant women at high     risk for gestational diabetes to a 24-week period of soy food consumption. This study will     also examine the effects of soy protein and isoflavones on glucose metabolism and lipid     levels among pregnant women at high risk for gestational diabetes, and on child's weight and     height at birth and 6 weeks of life.   "
36595|NCT02806713|"     Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a     retropubic midurethral sling operation.   "
36620|NCT02806375|"     A number of groups have demonstrated very low incidence of acute and chronic     graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in     haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse of     the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently one     of the most promising drugs in the treatment of steroid-refractory GVHD. On the other hand,     its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before     allogeneic SCT might improve the outcome. This pilot trial evaluates whether the combination     of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the risk of graft     failure and disease progression in myelofibrosis patients.   "
36621|NCT02806362|"     The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks     of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and     pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV     GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have     ESRD on HD.   "
36584|NCT02806869|"     This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from     healthy subjects under fasting and fed conditions which are necessary for mechanistic     absorption model development. Up to 30 subjects will be enrolled into this study. Each     subject will be asked to complete two GI tube insertion procedures. Subjects will complete     this study twice under the same conditions of the GI tract, either fasting state or fed     state, in order to provide intra-subject variability. A minimum of 7 days will separate each     GI tube insertion procedure. The objectives of this study are, as follows: Objective #1: To     acquire human GI physiology data including GI motility, pH of GI fluids, and GI fluid volume     under fasting and fed conditions; Objective #2: To measure drug concentration and calculate     drug dissolution in the GI tract in vivo under fasting and fed conditions; Objective #3: To     monitor plasma drug concentration and evaluate pharmacokinetics of administered drug during     GI tube insertion studies under fasting and fed conditions. These in vivo results will be     used to validate in vitro dissolution methods and to support computational and mathematical     modeling efforts, in order to develop an oral drug product optimization process that may be     applied to future drugs to maximize oral drug safety and efficacy.   "
36585|NCT02806856|"     Very early after the onset of the focal perfusion deficit, excitotoxic mechanisms can     lethally damage neurons and glia. Excitotoxicity triggers a number of events that can further     contribute to tissue death. Such events include peri-infarct depolarizations (PID) and     cortical spreading depolarization (CSD) within the peri-infarct zone or ischaemic penumbra.     Noninvasive brain stimulation techniques such as transcranial direct current stimulation     (tDCS) are emerging as promising tools, owing to their effects on modulating cortical     activity. Experimental studies have indicated that cathodic polarization of the cortical     surface blocks initiation of CSD. Moreover, it has been recently demonstrated in murine     stroke models that cathodal tDCS exerts a measurable neuroprotective effect in the acute     phase of stroke, decreasing the number of spreading depolarizations and reducing the infarct     volume by 20 to 30%.      The investigators propose here a pilot study, in acute middle cerebral artery stroke     patients, with a double blind randomization: cathodal tDCS versus sham tDCS. The duration of     this study will be two years. Fifty acute middle cerebral artery stroke patients will be     included. The tDCS will begin within 4.5 hours of symptom onset. The main criteria of     evaluation will be the extent of diffusion-weighted imaging (DWI) infarct volume between     imaging on admission and 24 hours later. The investigators propose the hypothesis that in     acute stroke patients, cathodal tDCS could be an adjuvant approach to recanalizing therapies.   "
36586|NCT02806843|"     Our study goal is to assess natural patient-therapist interactions in order to map such     human-human activities to robot-human interactions. Critical to accomplishing this mapping     will be determining the feasibility of a humanoid robot interacting with a patient in a more     intuitive and flexible way, while concomitantly investigating the issue of safe contact and     release.   "
36587|NCT02806830|"     In this study, ocular discomfort following intravitreal injection in naïve patients will be     studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular     discomfort.   "
36588|NCT02806817|"     Prospective, randomized, open label, two arms,, phase 0 clinical trial. HER2-negative breast     cancer patients recently diagnosed will be screened for trial participation.      A biopsy will be scheduled the week prior to or the same day as the FDG PET.     Paraffin-embedded tumor samples will be used to evaluate the stainings of Ki67, cleaved     caspase-3 and microvessels, and frozen tumor samples will be used to evaluate SDH staining.      The FDG-PET will be followed by the bevacizumab dose (15 mg/kg IV, single dose). After one     week, the PET will be repeated in order to detect the patients that have experienced FDG     uptake decay.      Right after, treatment with ME-344 (arm 1) or no treatment (arm 2) will start. ME-344 will be     administered at 10 mg/kg on day 8, 15 and 22. Surgery will be performed on day 28 (thus, 4     weeks after the bevacizumab dose, which is considered a safe window for antiangiogenics).      Fragments of the surgical specimen will be collected. Paraffin-embedded tumor sample will be     used to repeat (and compare) the stainings of Ki67, cleaved caspase-3 and microvessels, and     frozen tumor sample will be used to repeat (and compare) SDH staining.      Patients will come off trial in case of consent withdrawal, unequivocal disease progression     is observed, unacceptable toxicity occurs, or in case of intercurrent disease or any other     condition deemed incompatible with continuation in the clinical trial by the investigator.   "
36589|NCT02806804|"     This study evaluates the safety and immunogenicity of the quadrivalent influenza virus     vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3     groups,receiving the test vaccine, commercially available trivalent influenza vaccine and     trivalent influenza vaccine containing new influenza B component respectively. Each group has     800 subjects,2400 in total.   "
36590|NCT02806791|"     The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and     differentiation of hematopoietic progenitors commissioned to mature as neutrophils and     activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is     used to reduce the duration and complications of chemotherapy-induced neutropenia and to     stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells     in order to use them for autologous transplantation procedure.      Filgrastim and Lenograstim originator are marketed for many years and are considered the     reference molecules for the production of biosimilar.      For several years it is available and entered into common clinical practice the use of     filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.      Aim of the study is to analyze retrospectively a large series of patients and assess the     impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood     counts post autologous transplantation; the data will be compared with a historical cohort of     reference that has been treated with G-CSF originator.      The study results will not generate any diagnostic or therapeutic intervention in patients     still alive.   "
36591|NCT02806778|"     The use of protective ventilation (to maintain normoxia and normocapnia), optimise     haemodynamics, diagnose/treat seizures, therapeutic hypotermia etc is recommended for ICU     management of patients who have had cardiac arrest and remain in coma after return of     spontaneous circulation according to the latest International Guidelines. These actions     essentially aim to limit secondary brain injury but despite all therapeutic effort, the     cerebral oxygenation may remain inadequate and there is no validated method to avoid such a     state in real time.   "
36597|NCT02806687|"     Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in     Western countries, and its incidence has increased over the last 40 years. Curative surgery     to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of     patients is diagnosed with locally advanced tumors and/or metastases because they lack     specific symptoms and early markers for this disease. For these patients, palliative     armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more     recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for     PDAC is still very poor and there is great need for new treatments that can change this poor     outcome. In this context, the investigators have devised, in the past few years, a highly     innovative approach based on therapeutic gene transfer, which does not rely on a specific     genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that     SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit     tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of     these promising preclinical data, the investigators conducted past three years the first     clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy     (EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and     metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed     in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the     bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor     progression and dissemination. Our results tend to demonstrate therapeutic efficacy,     especially in patients with locally advanced tumors. Based on these encouraging results, the     investigators propose that patients with locally advanced PDAC at the time of diagnosis may     clinically benefit from this approach.      This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of     CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC.   "
36598|NCT02806674|"     Approximately 50% of people in the world are infected with H. pylori, and its eradication     rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for     infection include lower socioeconomic status, younger age, and geographic location.In the     present study, investigators aimed to perform a prevalence survey about risk factors for H.     pylori infection.To obtain the higher eradication of H. pylori and find out the relevance     between the diverse infection and clinical drug focused on refractory H. pylori infection.   "
36599|NCT02806661|"     Through comparative observation of robot vagus nerve preserving distal gastric cancer radical     surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus     nerve) operative and postoperative indicators, and evaluating the feasibility and safety of     vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer.     Which can provide the evidences for the clinical development of the preserving function     gastric cancer surgery.   "
36600|NCT02806648|"     A phase II trial to assess the activity and safety of PD0332991 in patients with well- and     moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with     overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)   "
36601|NCT02806635|"     This study investigates the effectiveness of www.OurRelationship.com, which provides     self-help, web-based programs to improve romantic relationships and related outcomes. Couples     will be randomly assigned to complete the OurRelationship program, the PREP Online program,     or a wait-list control group and followed for six months.   "
36602|NCT02806622|"     The purpose of this study is to compare hip passive range of motion (ROM) among division II     collegiate athletes in order to obtain normative data for future research. The investigators     hypothesize that there will be a difference in passive hip ROM among the different genders     and sports.   "
36603|NCT02806609|"     Objective: To evaluate the effect of cold water immersion in elayed onset muscle soreness,     muscle recruitment, dynamic postural control and quality of sleep in young soccer players.      Methods: The sample will consist of 28 soccer players between 18 and 21 years of the same     football club and with the same routine practices and games. At first athletes will respond     to the IC and will be submitted to the test of a repetition maximum. After three days the     athletes will analysis of muscle recruitment by electromyography and dynamic posture control     through the force platform both during the time of shooting, moreover, will respond to scale     the quality of sleep the previous night and one on pain, then they are instructed to perform     a fatigue protocol for the quadriceps and then will be randomized to one of four intervention     groups: cold water immersion, submersion in water at room temperature, or active recovery     control. The same APPRAISAL be remade into three new moments, 24, 48 and 72 hours after the     fatigue test.      Hypothesis: The variables will be considered: Pain intensity in the quadriceps muscle,     quality of sleep the night after intervention protocol, electromyographic analysis of the     rectus femoris, vastus medialis oblique and vastus lateralis at the time of shooting, as well     as postural control when the shot off.      It is intended to establish the best way of recovery of late quadriceps muscle pain and     contribute to the clinical practice of active recovery or rest in young soccer players.   "
36604|NCT02806596|"     This prospective study aimed to determine the minimal level of Bispectral index needed for     quality laryngoscopy before ear, nose and throat surgery in children.   "
36617|NCT02806414|"     This study will assess the role of topical Ivermectin 1% cream and its effect on protease and     antimicrobial peptide expression in rosacea. This is a single-site 16-week open label study     at University of California, San Diego. The investigators will do this by first measuring     serine protease activity and cathelicidin of all subjects. All subjects will receive     Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks.     Participants will return for monthly visits during which their clinical symptoms of facial     redness and number of facial papules will be scored, and they will have repeat tape     stripping. At the end of the study, tape strips will be analyzed to determine serine protease     activity of participants at each of their visits and expression of cathelicidin (LL-37) mRNA.     The investigators will then look at changes in serine protease activity and LL-37 expression     over time, and they will also determine whether or not these changes correlate with disease     severity.   "
36618|NCT02806401|"     The purpose of this prospective randomized study was to compare landmark-subclavian venous     access to ultrasound-guided axillary venous access when performed by pediatric     anesthesiologists.   "
36622|NCT02806349|"     The purpose of this study was to determine whether the co-administration of a     konjac-glucomannan fibre blend and American ginseng in a randomized, placebo-controlled,     cross-over trial can improve diabetes management.   "
36645|NCT02806050|"     The purpose is to evaluate whether non invasive in vivo imaging of the estrogen receptor (ER)     presence in metastatic breast cancer patient by means of 18F-fluoro-estradiol (FES) positron     emission tomography (PET) can be used to predict treatment response to palbociclib plus     letrozole. As ER expression predicts response to palbociclib in metastatic breast cancer     patients the investigators hypothesize that lesions with low uptake on FES-PET will not     respond to the combination of letrozole plus palbociclib.   "
36605|NCT02806583|"     Caring for people with dementia (PwD) at home requires an enormous amount of time,     organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD     often feel a high burden. Even though support groups on-site have shown positive effects on     the subjective well-being and on the perceived social support of ICs, relatives either have     no time or opportunity to leave the PwD alone or there are no support groups in the vicinity.     The Talking Time project therefore aims to close this supply gap by providing structured     telephone-based support groups in Germany for the first time. International studies have     shown resulting benefits for ICs.      Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled     trial. The effects of the 3-months Talking Time intervention will be compared to a normal     care group. Outcomes will be measured at two different times (baseline = T0, after 3 months     =T1). The control group will receive the Talking Time intervention after T1.      ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on     four days per week in the last six months. Exclusion criteria are psychiatric disorders of     the IC.      Primary outcome of the effectiveness elevation is the subjective well-being of the relatives     measured by the mental component of the SF-12. Secondary outcomes are the physical component     summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction     Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative     and qualitative data sources will be collected addressing reach, fidelity, and dosage.   "
36606|NCT02806557|"     The purpose of this trial is to observe the changes in white cell counts in patients with     cancer during chemotherapy and to determine if changes in the white cell count in the early     days during chemotherapy can be used as a predictor of severe neutropenia and its     complications.   "
36607|NCT02806544|"     This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with     locally advanced hormone receptor positive breast cancer in a low/middle income country.   "
36608|NCT02806531|"     This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged     6-35 months old by the method of both passive and active surveillance.   "
36609|NCT02806518|"     Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing     radiation or contrast injection. The study evaluates if DIRT can be an alternative to     computed tomographic angiography (CTA) in perforator mapping. DIRT findings are compared with     hand-held Doppler, CTA and intraoperative findings.   "
36610|NCT02806505|"     This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in     participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were     undergoing hemodialysis.   "
36611|NCT02806492|"     The purpose of this study is to determine whether cerebral blood flow and cerebral tissue     oxygenation is most dependent on cardiac output or on mean arterial pressure in patients     undergoing cardiac surgery with the use of cardiopulmonary bypass.   "
36612|NCT02806479|"     This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in     comparison to patients with well-understood arrhythmogenic substrate (ischemic     cardiomyopathy), as well as to individuals free from arrhythmogenic substrate   "
36613|NCT02806466|"     -  Background: Asthma is a frequent disease characterized by bronchial hyperresponsiveness,          inflammation and remodeling. Consistent epidemiological data indicate that outcome of          asthma in adults may be determined in early childhood. This may be due to bronchial          remodeling, an abnormal repair process that contributes to the development of poorly          reversible airway narrowing. It appears very early in the natural history of the disease          and involves increased mass of bronchial smooth muscle (BSM). The mechanism of such an          increase has been related with an increase in smooth muscle cell proliferation.          Recently, we have demonstrated that in severe asthma, BSM increased proliferation is          induced by an enhanced mitochondrial biogenesis. Moreover, we have also shown that          immature human, non-asthmatic airway smooth muscle cells (ASMC) proliferate to a greater          extent than normal adult ASMC, in a similar fashion to adult asthmatic ASMC. Immature          ASMC may thus have great potential to stimulate airway remodeling. We thus hypothesized          that remodeling is an early process and certain characteristics of ASMC in severe          preschool asthma may predispose such children to persistent remodeling with airway          obstruction later in life.        -  Purpose: To investigate prognostic factors of airway remodeling in preschool children,          with special attention to ASMC proliferation (mitochondrial mass & biogenesis).        -  Methods: In the initial phase of the project, 75 severe asthmatic preschool children (<5          yr) will be prospectively recruited from the CHU de Bordeaux and the CHU de Toulouse          according to the Haute Autorité de Santé criteria. Inclusion visit will include          written informed consent, asthma control evaluation, clinical examination, lung function          testing (exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for          total IgE levels. Bronchial specimens from all subjects will be obtained by fiberoptic          bronchoscopy at visit 2. Airway remodeling will be evaluated by morphological analysis.          After smooth muscle mitochondria will be analyzed by electronic microscopy &          immunoblotting. Comparison between the 2 groups will be performed by unpaired t tests          for parametric data and x2-tests for non-parametric data. In the second phase of the          project, patients will then be followed-up till the age of 7-10 yrs, when another          bronchoscopy with biopsies will be performed.   "
36614|NCT02806453|"     A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive     of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux     Questionnaire Revised).      The parents of all of the enrolled infants will be reassured on the benign nature of the     condition and will advise to apply lifestyle changes for one week.      Than, the patients will be randomized into one of the two sequence treatment groups. (group     A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks.     Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.   "
36615|NCT02806440|"     This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in     patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over     study.      It is a 2-center study that takes place at The Multidisciplinary Pain Center in Copenhagen     and at The Multidisciplinary Pain Center in Give.   "
36616|NCT02806427|"     This prospective observational study seeks to demonstrate the ability to meet nutritional     needs of a calorically dense enteral formula in critically ill patients.   "
36619|NCT02806388|"     This study aims to screen tumor molecular profile for better selection of anticancer     treatment, in particular, allocation to clinical trials if available.   "
36763|NCT02804477|"     This study aims at finding degree of adherence of patients to their chronic pain medication     prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8,     self- reported questionnaire. Also relationship of various demographic, disease related and     opioid related factors to medication adherence.   "
36764|NCT02804464|"     Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on     plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell     transplant patients when compared with standard clinical diagnostics   "
36623|NCT02806336|"     Obesity is a major risk factor for mobility problems in older adults and many older adults     use a walking aid to help with their mobility. The use of a walking aid changes normal     walking patterns and makes walking harder, leading people to have more functional problems.     The purpose of this study is to test the effects of 12 months of a multi-modal balance     intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional     performance, balance, and economy of gait. Participants will be one of 120 participants in     the VAMHCS. Participation in this study is voluntary. The research will be conducted at the     VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation     in the study will last 24 months.   "
36624|NCT02806323|"     The goal of this pilot study is to determine the feasibility of an individually tailored yoga     program delivered in a group setting for the treatment of chronic neck and back pain in a low     income population. Chronic pain is one of the most common, costly, and disabling conditions,     and is often refractory to treatment. Yoga is a promising treatment for chronic pain. This     pilot study will test the hypothesis that study subjects will participate in a voluntary 12     week yoga intervention for the treatment of chronic neck and back pain, as assessed by     attendance at 12 weekly yoga practice sessions. Secondary outcomes will include change in     pain and quality of life scores over the 12 week study period as assessed by the Visual     Analog Scale for Pain Severity and EQ-5D-3L.   "
36625|NCT02806310|"     Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with     valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to     play role in abnormal aortic distensibility and stiffness with impairment of aortic     elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not     understood completely. In a recent study podocan is found in extracellular matrix (ECM) of     human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no     current effective therapy that can alter the progression of aortic dilatation in bicuspid     valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated aorta     and aortic dissection. In this study the aim is to investigate the association between     podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide     more effective and physiological understanding of disease process and potential target in     prevention and treatment for aortopathy.   "
36626|NCT02806297|"     Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after     resolution of pain for mild gallstone pancreatitis.   "
36627|NCT02806284|"     The purpose of this study is to determine wether skull trauma or neurosurgery affect the     immune response to two vaccine types.   "
36628|NCT02806271|"     Worry postponement is a commonly recommended treatment component in cognitive behavioral     therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally     occurring instances of worry to a designated 30 minute worry period later in the day.     Despite being commonly recommended, there is little known about the efficacy and mechanisms     of worry postponement. The purpose of this study is to determine the efficacy and mechanisms     of change of a two-week worry postponement intervention in people with Generalized Anxiety     Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two     weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only     control condition. Changes in worry or associated features will be examined at post     intervention and at a 2-week follow up.   "
36629|NCT02806258|"     In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT     administered sequentially in patients with intermediate ad high risk BC. The hypothesis is     that combined PST-sequential APBI may increase the rate of pCR, breast conservation and     survival without additional toxicity, as seen with WBI   "
36630|NCT02806245|"     Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low     cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased     and emphasis has shifted to post-operative morbidity and recovery. Children with CHD     undergoing surgery with CPB can experience well-characterized post-operative cardiac     dysfunction. When severe, patients can develop clinically important low cardiac output     syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is     primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which     affect the strength of the heart's muscular contractions. These are used to maintain adequate     blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to     myocardial function and may increase risk for post-operative arrhythmia and impair     post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2).     In combination with the increased VO2 associated with CPB-induced systemic inflammatory     response patients can develop a critical mismatch between oxygen supply and demand,     essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic     stability without increased VO2 are beneficial. This study will test whether BiVp, a     specialized yet simple pacing technique, can improve post-operative CI and recovery in     infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes     that Continuous BiVp increases the mean change in CI from baseline to 72 hours in infants     with EMD following CHD surgery compared to standard care alone.   "
36633|NCT02806206|"     Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the     small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about     8 hours. During this time the capsule takes pictures as it passes through the small bowel. In     about 15-20% of capsule tests the battery expires before the capsule passes through the     entire small bowel into the colon. Incomplete tests indicate that a variable portion of small     bowel was not visualized. Incomplete tests are associated with potential missing of     abnormalities in the portion of small bowel that was not reached. The capsule test may often     required to be repeated but the problem of incomplete examination may persist. At present no     medication has been approved to increase the rate of complete capsule tests.      Prucalopride is a medication that has been approved in Canada and Europe for the treatment of     chronic idiopathic constipation. Animal and human studies suggested that prucalopride may     enhance the movement of the stomach and the small bowel. A recent presentation at a medical     meeting suggested that prucalopride may accelerate the passage of the capsule camera through     the small bowel without increasing the chance to miss a lesion in the small bowel.      The purpose of this study is to asses if the administration of a single dose of prucalopride     is going to decrease the time required by the capsule to move through the small bowel.   "
36634|NCT02806193|"     The Global CMR Registry aims to promote collaboration of CMR sites worldwide in setting     imaging and reporting standards, assessing its diagnostic impact on patient care, and     determining the cost-effectiveness of CMR imaging. It will be the largest collective body of     evidence reflecting the current clinical applications in patient care, which healthcare     payers and governing bodies alike can depend on when metrics such as testing appropriateness,     common indications, and diagnostic effectiveness are called for. It will also be able to     reflect any changes in patient impact from CMR over time as technical development evolves.     Furthermore, it will allow an assessment of improvements in diagnostic and therapeutic     thinking, risk stratification, and cost-effectiveness relevant to current patient management.   "
36635|NCT02806180|"     This is a randomized controlled trial comparing the success of US guided peripheral IV     placement between single vs dual-operator technique among a convenience sample of patients     with moderate or difficult vascular access in a tertiary care Emergency Department.   "
36636|NCT02806167|"     Expedient diagnosis and management of acute cauda equina syndrome (CES) is essential to     prevent long-term neurological sequelae for these patients. The clinical diagnosis of CES is     confirmed using magnetic resonance imaging (MRI). However the clinical features of CES     (secondary to bladder and bowel sphincter dysfunction) are variable and are common presenting     features of other pathologies of the bladder and bowel, therefore most patients who undergo     MRI for suspected CES have no compressive lesion evident on the MRI, excluding the diagnosis     of CES. Urgent MRI scanning performed out of hours is therefore often unnecessary, however,     the morbidity to the patient due to a delay in diagnosis is so significant that urgent MRI     scanning is the current gold standard and duty of care in all cases of suspected CES. More     objective methods of assessing patients with suspected acute CES could allow rationing of out     of hours MRI scanning and reduce inappropriate admission without impacting patient safety.      The aim of this study is to evaluate the effectiveness of a clinical algorithm which utilises     digital rectal examination and ultrasound bladder scanning to stratify patients into high and     low risk groups. Patients considered high risk will be admitted and sent for urgent MRI,     whereas low risk patients will be discharged and undergo MRI scan within 5 days of     presentation.   "
36637|NCT02806154|"     The investigators could hypothesize that age-related changes in body composition parameters     play a role in the variable tolerance to chemotherapy in the elderly.      However none of the studies relating body composition and chemotoxicity included elderly as a     specific subpopulation. Furthermore in the majority of studies, body composition analyses are     based on the estimation of muscle mass by CT scanner (axial L3 section). This method is to     date not validated in the elderly cancer patients. Nevertheless some studies used Dual Energy     X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment of body     composition in older adults.      The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of     the 4 limbs) operationalized as an index by dividing the muscle mass by squared height     following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass     of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.      The finding that body composition is associated with poor tolerance of chemotherapy could     lead to consider these parameters in the treatment decision of the elderly cancer patients     and improve the current decision-making algorithms when treating older adults.   "
36638|NCT02806141|"     This study is planned to compare the clinical efficacy and safety of aerosolized plus     intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of     ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii     in the neonates.   "
36639|NCT02806128|"     Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute     anterior circulation cerebral infarction.   "
36640|NCT02806115|"     Investigators found that the degree and the duration of aceto-whitening differed between     gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed     a severe degree of aceto whiteness and the whitening continued longer than the surrounding     normal mucosa, which investigators called severe whitening and delayed fading, and     investigators realized that GIM could possibly be diagnosed by using these differences.The     aim of this prospective study was to investigate the efficacy of severe whitening and     delayed fading for diagnosing GIM.   "
36641|NCT02806102|"     This study is intended to provide contemporary data on the residual cardiovascular risk in     all consecutive patients with acute myocardial infarction, especially in patients who     survived stably within one-year after percutaneous coronary intervention.      In addition, this study will identify which baseline clinical, angiographic, or treatment     factors are associated with residual cardiovascular risk and bleeding events   "
36642|NCT02806089|"     Aim of this study is to determine in chronic kidney disease patients:        -  the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C          reactive protein and decrease in serum albumin) on voluntary muscle strength impairment        -  the relationship between voluntary muscle strength and muscle mass        -  the relationship between voluntary muscle strength and lean body mass        -  the correlation between voluntary muscle strength and physical activity   "
36644|NCT02806063|"     Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and     its treatment continues to fuel the debate on how to manage it appropriately.      One stage and two stage exchange surgery both are the conventional surgical procedures for     chronic PJI commonly used to date.      Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional     impairment between surgeries and a high socio-economic coast) encouraged many surgical teams     to adopt one stage exchange surgery which provides equivalent or better outcomes. However one     stage surgery encounters a major conceptual difficulty when it comes to implant the new     prosthesis in a surgical site microbiologically undetermined and potentially contaminated.      Investigators suppose the new prosthesis is implanted in a contaminated setting regardless of     bacteria type and antibiotic therapy duration before arthroplasty.      The total lack of data answering this question motivated the conception of this prospective     study in order to describe the microbiological setting where is implanted the new prosthesis     with one stage exchange surgery after surgical excision and antibiotic therapy initiation in     chronic PJI.   "
36657|NCT02805881|"     Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation     (CTO-TNS) in Major Depressive Disorder (MDD)   "
36646|NCT02806037|"     Intraoperatively, the surgeon will interrogate the liver with ultrasound. The time spent by     the surgeon using the ultrasound is recorded. If all lesions seen on pre-op imaging were     found, the patient does not have the Pathfinder Explorer system applied. If one or more     lesions cannot be found, then the Pathfinder Explorer system is calibrated and a tracking     device is attached to the ultrasound probe, which the surgeon will use to reattempt     localization of the missing tumor. The Pathfinder Explorer system operates in real-time in     conjunction with the ultrasound.   "
36647|NCT02806024|"     The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is     effective for reducing blood loss during high risk surgical procedures related to placenta     previa and placenta accreta. TXA is currently used in other types of surgery for patients who     are expected to have a large blood loss, such as orthopedic or open heart surgery.   "
36648|NCT02806011|"     This is a 3-year (+30 days) long term follow up study to evaluate the safety of Livercellgram     in subject who participated in and completed the Livercellgram Phase 2 trials (refer to     ClinicalTrials.gov.Identifier: NCT01875081).      This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic     liver cirrhosis. Subjects who signed this follow-up observation informed consent form will     participate in a safety assessment (tumor marker test, occurrence of adverse events and     serious adverse events, clinical laboratory tests, vital sign, physical examinations.).   "
36649|NCT02805998|"     The overarching goal is to utilize a randomized control design to examine efficacy of     web-based cognitive behavior therapy (CBT-I) plus treatment as usual compared to treatment as     usual alone for insomnia and depression outcomes among pregnant women with insomnia at high     risk for depressive relapse/recurrence (n=208).   "
36650|NCT02805985|"     This study is a post-market clinical follow-up study. A post-market, prospective clinical     trial will be conducted. The data collected from this study will serve the purpose of     confirming safety and performance of the FLXfit™ implant.   "
36651|NCT02805972|"     The purpose of this study is to understand how the opioid system is involved in eating     behavior.   "
36652|NCT02805959|"     To study the motility of the bowel in constipated patients. Looking at the difference between     young and elderly patients with constipation.   "
36653|NCT02805946|"     This study evaluates the the pharmacokinetics of posaconazole (new solid oral and IV) given     as prophylaxis to patients who are at risk for developing fungal infections after receiving     conditioning therapy (except strictly non-myeloablative (NMA)) for allogeneic Stem Cell     Transplant (SCT), remission induction chemotherapy for acute myeloid leukemia (AML) or myelo     dysplastic syndrome (MDS) or being treated for severe graft versus host disease (GvHD) and     determines the impact of mucositis on the pharmacokinetics of posaconazole new solid oral.   "
36654|NCT02805920|"     Adductor canal block (ACB) is a new technique gaining acceptance as an alternative analgesic     method of femoral nerve block (FNB) following knee surgery. The advantage of ACB is its     dominant sensory nerve block effect. It preserves quadriceps muscle strength compared with     the FNB. This will serve as potential gain for early rehabilitation and thereby functional     outcome. Adequate direct injection of local anesthetic into the canal will block four nerves:     the saphenous nerve, the nerve to the vastus medialis, the medial femoral cutaneous nerve,     and the terminal end of the posterior division of the obturator nerve. Anterior cruciate     ligament reconstruction (ACLR) is often associated with postoperative severe pain.     Postoperative early rehabilitation is the primary focus to restore pre-injury status and is     an essential part of the full recovery, especially that this rehabilitation extents over a 6     month period. Early elimination of pain is necessary to achieve this goal. However, there are     no clear conclusive clinical reports defining the adequate analgesic volume-dosage of local     anesthetic for ACB for postoperative ACL pain management. The investigators speculated that     volume-dosage manipulation play key role in the effective of ACB for postoperative pain. The     investigators conducted this prospective, randomized, observer-blinded trial to compare 3     combinations of volume and dosage of 0.25 % bupivacaine for US-guided ACB. The first aim of     the investigation is to compare the analgesic effect of ACB 0.25% bupivacaine of the 3 doses     as assessed by the visual analog scale (VAS) pain scores. The second aim were duration of     analgesia, as defined by first demand for analgesia, and subsequent 24-h consumption.     Physiotherapy tolerance and time to discharge were evaluated. Side effects were also     assessed.   "
36765|NCT02804451|"     The aim of the study was to compare the intubation time and effectiveness, the grade of     larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices:     a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and     ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.   "
36655|NCT02805907|"     Introduction: There are many cross-sectional studies in children and adults indicating that     low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer     lung function, decreased response to glucocorticoids and more frequent exacerbations.     Moreover, as there is a significant group of asthmatic patients having insufficient control     of their disease, despite high doses of inhaled corticosteroids, we have investigated new     treatment alternatives, which include vitamin      Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with     vitamin D deficiency in degree of asthma control.      Materials and methods: A prospective, controlled, randomised, triple-blind study was     conducted with a follow-up of 6 months. The patients recruited were over 18 years of age with     a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels < 30 ng/ml. Patients were     excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements, kidney     disease (creat. > 2 mg/dl), hypercalcaemia (corrected with proteins > 10.5 mg/dl), a repeat     episodes of renal colic, any gastrointestinal disease that might interfere with vitamin D     absorption, or severe psychosocial problems, or were pregnant or breast-feeding. The     randomisation process assigned patients to one of two groups: a group that received vitamin D     (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral     route) and another group that received placebo in a presentation with an identical appearance     and the same administration regimen. Demographic, clinical, spirometry and laboratory     endpoints were collected. The primary endpoint was degree of asthma control as determined by     the internationally validated Asthma Control Test (ACT). The secondary endpoints were asthma     exacerbations, dose of inhaled corticosteroids and quality of life as measured using the     Mini-AQLQ (Asthma Quality of Life Questionnaire).   "
36656|NCT02805894|"     This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with     either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will     receive only EBRT and the other group will receive a Brachytherapy boost and EBRT.Both groups     will receive treatment with androgen deprivation. There will be 2 consecutive steps, a dose     escalation and a subsequent dose expansion part.   "
36658|NCT02805868|"     The main purpose of this investigational research study is to determine how safe and     tolerable the study drug siltuximab is in patients with myelofibrosis (MF). This medication     has been approved by the FDA for another condition (multicentric castleman's disease (MCD),     but not for myelofibrosis (MF). In MCD, siltuximab resulted in improvement in symptoms and     anemia. While MCD and MF are different diseases, they share some common features including a     protein call interleukin-6 (IL-6) that may be important in causing symptoms of MCD and MF.   "
36659|NCT02805855|"     The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal     stromal cells to treat symptoms of mild to severe knee osteoarthritis.   "
36660|NCT02805842|"     Aim The primary objective of this study is to compare medication adherence with medical     therapy in patients receiving once-daily versus twice-daily tacrolimus regimens.      Participants 60 adult renal transplant patients randomized 1:2 into twice-daily and     once-daily tacrolimus groups      Outcomes The primary outcome will be medication adherence to the once-daily and twice-daily     regimens, measured in terms of implementation. Secondary outcomes will include graft and     patient survival, renal function and adverse events. Follow up - 12 months   "
36661|NCT02805829|"     This trial is to evaluate the safety and effectiveness of activated and expanded in vitro     autologous NK cells following trastuzumab treatment for patients Human Epidermal Receptor-2     overexpressing advanced gastric cancer.   "
36662|NCT02805816|"     The investigators will perform prospective observational multicenter study which includes     children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study     group) and children without suspicion of CD who underwent gastroscopy for other reasons. The     investigators will compare sensitivity, specificity and predictive values of several     serological kits of TG2 (tissue transglutaminase) (Bioplex 2200, Bioflash, Phadia 250,     Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD     according to histological findings.   "
36663|NCT02805803|"     Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement     when symptoms duration is greater than 30 days or debridement with modular set replacement     when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive     antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients     and those who refuse reoperation.      There is limited data available on PSA modality, its tolerance and efficacy, this lack of     data motivated us to concept a prospective study of long term patient follow up with PJI     treated with prolonged suppressive antibiotherapy.   "
36664|NCT02805790|"     This is a Phase 2, randomized, double-blind, placebo-controlled crossover study which will     enroll up to 36 subjects (anticipated) with genetically confirmed mitochondrial disease who     have completed participation in the SPIMM-201 (MMPOWER) study. Subjects will be randomized     (1:1) to one of two sequence groups: 4-weeks of treatment with 40 mg elamipretide     administered once daily subcutaneously in Treatment Period 1 followed by 4-weeks of treatment     with placebo administered once daily subcutaneously in Treatment Period 2 (separated by     4-week washout period), or vice versa   "
36665|NCT02805751|"     The purpose of this study is to measure the mechanical properties of the tendon after     conservative treated Achilles tendon ruptures with or without early controlled loading. This     is done in a randomized trial and the mechanical properties are measured using roentgen     stereometric analysis (RSA).      The hypothesis is that early weightbearing improves mechanical properties of conservative     treated Achilles tendon ruptures without causing elongation of the tendon.   "
36666|NCT02805738|"     A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to     Evaluate the Efficacy and Safety of CKD-390 tablet   "
36667|NCT02805725|"     Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in     patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD)     have been determined (phase I trial).   "
36668|NCT02805712|"     This small pilot study will be assessing the the impact of a standardized, social-worker led,     longitudinal palliative care intervention on alignment of patient and physician understanding     of prognosis and goals of care. Secondary objectives include assessing the impact of this     intervention on documentation of advanced care planning and end of life preferences, symptom     burden, quality of life and health care utilization.   "
36670|NCT02805686|"     The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be     detected at the infra-clinical state, when it can still be reversible. Identifying early     retinal anatomical changes has always represented (a challenge for medical interns,     dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its     screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a     long and tedious exam, offered by only few medical centers. It is recommended to find a     simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid     (junction line between, the external and internal photoreceptor segments) using optical     coherence tomography (OCT-SD) en face enables us, to obtain a panoramic viewing of the     state of the photoreceptor layer, and to detect any modification, even subtle, within this     layer. The OCT-SD en face can be easily done by any ophthalmologist who owns one.      The proportion of en face OCT-SD showing suggestive retinal damage and patients who present     retinal damage in relation with synthetic antimalarial treatments and diagnosed by mfERG is     considered in this study.   "
36671|NCT02805673|"     At present, the literature does not account for much of scientific data on the assessment of     osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a     pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic     interventions in the treatment of FM, in order to improve the painful experiences of FM     patients. This study must include 44 patients with FM according to (American College of     Rheumatology) ACR criteria and followed the University Hospital of Caen.      The osteopathic care will last eight months and will be followed by a report three months     after the end of osteopathic interventions. This in order to evaluate the effect in the short     term and long term, of osteopathic care in patients with FM.   "
36673|NCT02805647|"     This study was designed to determine the impact of vitamin D serum levels and vitamin D     receptor (VDR) polymorphisms on the occurrence of low energy fractures in children.   "
36694|NCT02805374|"     The objective of this study is to evaluate the effect of food on the pharmacokinetics of a     single oral dose of ASP1517 in non-elderly healthy adult male subjects.   "
36674|NCT02805634|"     The main goal of this study is to determine if the Triple Stimulation Technique (TST) can be     correlated to performance in the manual dexterity 'nine holes peg' test, within a control     group and a group of patients with multiple sclerosis.      TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis:     magnetic stimulation and electroneuromyography. It is based on the principle of two     collisions between the descending central stimulation (magnetic stimulation) and the     ascending peripheric stimulation. TST allows to better quantify central nervous system     diseases. The abnormal amplitude registered by TST is proportional to the intensity of     conduction disorders. The evaluation of these disorders is more precise than with the     magnetic stimulation technique alone.      The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy.     The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove     them as quickly as possible. The hand must stay in a depression within the plate, thereby     insuring a constant distance between the hand and the pegs.      The nine hole peg will be realized first, and the triple stimulation examination performed     after. The acquired data will be analyzed in order to find a correlation between the     impairment level given by these two tests.   "
36675|NCT02805621|"     Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial     on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.   "
36676|NCT02805608|"     The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG     PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder     cancer   "
36677|NCT02805595|"     This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus     tracts in adult patients with hidradenitis suppurativa.   "
36678|NCT02805582|"     The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper     arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs     to be completed by an intercostobrachial nerve block. The optimal access for an ultrasound     guided block of the intercostobrachial nerve is not yet known. The investigators compare a     proximal and a more distal approach to the nerve referred to onset time, sensory blocked area     and duration.   "
36679|NCT02805569|"     Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced     video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards     the larynx around the steep blade angulation despite adequate visualization of the glottis.     Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators     hypothesized that using articulating stylet (AS) would enhance first attempt intubation,     shorten the intubation time, reduce the possibility of the soft tissue trauma compared to     conventional intubation stylet (IS) in patients with difficult airway .   "
36680|NCT02805556|"     A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing   "
36681|NCT02805543|"     Objective: The main target of this study was to research the early changes of retrobulbar and     intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes     (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy (DR).      Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy     people (control group) were recruited to research the early changes of renal function,     retrobulbar and intrarenal hemodynamics, and then to research the correlation between them.     The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral     interlobular renal arteries were evaluated using Doppler Sonographic; the secondary endpoints     were the retrobulbar hemodynamics RI in the bilateral central retinal artery (CRA), posterior     ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using color doppler imaging     (CDI); the tertiary endpoints were the biochemical endpoints: blood-fat (TC, HDL-C, LDL-C,     and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN, Cr, and GFR); in addition, the     albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.   "
36682|NCT02805530|"     Non-small cell lung cancer (NSCLC) is the most frequent neoplasm worldwide and also     represents the main cause of cancer death. However, it represents the main cause of death by     cancer. The prognosis of survival at 5 years is poor, approximately 13-15%.      Various studies suggest that patients who clinically present with a limited number of     metastases, a term defined as oligometastatic disease, could have a better prognosis of     survival with a radical treatment, than for their counterparts with a greater number of     metastasis.      The purpose of this study is to add more information to the current medical literature about     the benefits in overall survival of radical treatment of oligometastatic disease in patients     with NSCLC and equal or less than 5 synchronous metastases at the time of diagnosis.      The outcomes of the study are to determine the global survival and progression-free survival     in patients with synchronous oligometastatic (equal to or less than 5 sites) advanced NSCLC     undergoing radical treatment of all metastatic sites and the primary tumor.   "
36683|NCT02805517|"     This will be a single-arm prospective internally-controlled study. Patients will undergo     percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm     instruments are added or substituted for conventional 5 or 10 mm trocars. Multiple outcome     measures (endpoints) will be measured including time to first opioid use, total inpatient     opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to     ambulation, length of hospital stay, presence of any intraoperative or postoperative     complications, operating time, estimated blood loss, and other routine parameters collected     in a prospective surgical study   "
36684|NCT02805504|"     A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine     given by local injection at all the wound sites in patients undergoing urologic surgeries.   "
36695|NCT02805361|"     REWARD is an Non Interventional study aims to describe the changes in the clinical outcomes     of Type 2 Diabetes Mellitus patients who are treated with Dapagliflozin for a period of one     year including the fasting period of Ramadan.   "
36696|NCT02805348|"     The objective of this study is to assess the long-term safety and efficacy of bixalomer under     post-marketed setting.   "
36957|NCT02801955|"     For preoperative staging and prediction of peritoneal dissemination of gastric     adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA     19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma     treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor     markers.   "
36685|NCT02805491|"     Hypospadias is the most frequent malformation of the external genital organs in the male     infant. Incomplete virilization of the genital bud results in hypoplasia of the tissues on     the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and     an incompletely formed foreskin. The condition is generally isolated and the aetiology is     unknown. The pathogenesis is complex and involves hormonal, genetic and environmental factors     (which are probably interlinked).      A doubling in the incidence of hypospadias over the last 15 years has emphasized the probable     role of environment factors: in fact, certain exogenous compounds (collectively referred to     as endocrine disruptors (EDs)) may modify hormonal functions and thus exert harmful effects     on the organism or its offspring.      The male urethra develops between the 8th and 16th weeks of gestation in an     androgen-dependence manner. In utero exposure of the foetus to EDs may have a     physiopathological role in the abnormal development of the male genital bud and thus in the     development of hypospadia. These EDs are present in many different substances, such as     pesticides.      Many epidemiological studies have evidenced an increase in the incidence of hypospadias in     children born to exposed parents. Furthermore, animal studies have identified a certain     number of compounds associated with hypospadias after in utero exposure. However, human     foetal samples have very rarely been assayed in an attempt to measure the true level of     impregnation (i.e. the dose received). At present, it is not possible to draw firm     conclusions with regard to the true extent of a link between EDs and the increased incidence     of hypospadia.      The HypoMeco project is a prospective case-control study.   "
36686|NCT02805478|"     This is an observational study of cardiovascular risk factors and arterial or cardiac     function in subjects with overweight or obesity. Subjects must be between 30 and 65 years of     age, have a body mass index >27.0 kg/m2 and free from known heart disease and digestive or     psychiatric disorders. Study aims include identifying sex-differences in traditional     cardiovascular risk factors and structural and functional abnormalities in arteries and the     heart in subjects with overweight or obesity, and how this is influenced by physical fitness.   "
36687|NCT02805465|"     This study is a multicenter, prospective, randomized cross-over study to compare His Bundle     Pacing (HBP) with Bi-Ventricular Pacing (BiVP) in HF Patients with AF who need     atrial-ventricular node ablation.   "
36688|NCT02805452|"     The purpose of this study is to determine whether Succinate of Solifenacin reduces the     OverActive Bladder syndrome occurring during prostate irradiation.   "
36689|NCT02805439|"     The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as     adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to     antidepressant therapy.   "
36690|NCT02805426|"     This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women     (125 per study arm).      The objective of the study is to determine the efficacy and tolerability of oral tranexamic     acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH).     Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the     calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized     to receive either tranexamic acid or placebo, both in tablet form. All participants will     receive 800 mcg sublingual misoprostol (4 tablets 200mcg each).      The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to     misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding     without recourse to further treatment in significantly more women.   "
36708|NCT02805192|"     Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of     medication if a valid weight or age is entered. During emergency situations, these values are     often unknown. An App has been developed to measure the size of a child noninvasively. This     App is now to be validated in clinical practice. App measured size is calculated and compared     to the real size of a child. Via known percentiles of age/weight of the child is calculated     upon the App measured size. This value is compared to the mother`s, physician`s and nurses     estimation of the size and weight.      Depending on the size multiple algorithms exist to estimate weight, age and medical values.     (Kindersicher ®, Notfalllineal ® and Broselow Tape ®). These estimations by the     calculations will also be compared to actual weight and age.      Children from 0-12 years of age are included in the emergency Department of the Children`s     Hospital of the University of Zurich after informed consent obtained by the parents. No     therapy decisions from these calculations will be made. The therapy is independent of this     study.   "
36709|NCT02805179|"     This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT)     with concurrent temozolomide in patients with newly diagnosed glioblastoma.   "
36691|NCT02805413|"     Main objective of the experiment is threefold: 1) to technically test a device for central     blood pressure estimation for its applicability in a spaceflight-related environment and on     the International Space Station. 2) Furthermore the objective is to compare central blood     pressure estimates based on arterial pressure readings of different peripheral arteries. For     central blood pressure estimation mathematical transfer functions as described by Karamanoglu     and colleagues (11) will be used. 3) Finally the experiments' objective is to simultaneously     apply phonocardiography together with ECG and carotid plethysmography to determine cardiac     systolic time intervals in parabolic flight during gravity transitions.      Secondary objective of the experiment is to simultaneously measure key variables of the     central circulation during gravity transitions to expand the understanding of cardiovascular     regulation in weightlessness. Furthermore spirometric measurements shall be performed during     a parabolic flight day to observe changes in end-expiratory CO2. Arterial CO2 content is     central for cardiovascular regulation.      Our main hypothesis is that there is no difference between different methods of central     arteria pressure determination.      Concerning our secondary objective, this experiment is designed as an observational study.     Thus no clear hypothesis was generated but the measured cardiovascular and respiratory     variables will be analysed regarding differences correlated to gravity.   "
36692|NCT02805400|"     The main objective of this experiment is to evaluate the alterations in brain cortical     activity induced by micro- and hypergravity conditions.      A secondary objective is to correlate changes in brain cortical activity and brain     oxygenation level with neurocognitive performance.      Another secondary objective is to differentiate between the influences of hemodynamic and     electro cortical changes and the influence of stress on cognitive performance alterations   "
36693|NCT02805387|"     Dystocic deliveries and the use of bicarbonate   "
36697|NCT02805335|"     PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report     morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines     it's recommended to use sutureless device. The devices actually used are unsatisfactory     because of the high risk of migration, accidental removal.      A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the     possibility to simplify the after care. This device may stay on patient for 4 weeks. Others     devices may be changed 1/week.      The investigators aimed to compare morbidity between this new device and the old one. The     investigators also want to perform an economic evaluation of this device and compare patient     quality of life.   "
36698|NCT02805322|"     Quantify the reliability and agreement of estimated core body temperature using the InstaTemp     MD™ and other widely marketed reference Thermometers   "
36699|NCT02805309|"     Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older     adults with severe symptomatic aortic stenosis who are considered high risk for surgical     aortic valve replacement. Despite symptomatic and survival benefits, many patients experience     functional decline after TAVR. This pilot study aims to test the feasibility of a home-based     exercise intervention targeting endurance, strength, and balance as well as cognitive     behavioral intervention to improve physical functioning and disability after TAVR.   "
36700|NCT02805296|"     Intensive phototherapy in form of double light is used worldwide in the treatment of severe     neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency     of phototherapy. This study investigates whether double phototherapy reduces total serum     bilirubin faster than single light during intensive phototherapy, using light emitting     diodes, and whether there is an upper limit for the efficacy of phototherapy.   "
36702|NCT02805270|"     The implementation of a medication reconciliation intervention including: medication     reconciliation on admission and discharge, bedside medication counselling and take-home     medication list, on the development of adverse drug events within 30 days post discharge as     primary outcome. Secondary outcome is the evaluation of its impact on health care resource     utilization   "
36703|NCT02805257|"     This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed     valve implantation. Approximately 100 patients will be enrolled, with half receiving the     Mitomycin-C treatment and the other half receiving placebo treatment.   "
36704|NCT02805244|"     A mass balance study to determine the routes and rates of elimination of radioactivity, to     determine total radioactivity in plasma and whole blood over time and compare levels to     JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters     of JTZ-951 and its metabolite(s).   "
36705|NCT02805231|"     This study investigated whether vitamin D receptor gene polymorphism is altered in primary     open-angle glaucoma subjects carrying the risk allele.Primary open-angle glaucoma patients     and age-matched people in the Han population were enrolled. Vitamin D receptor polymorphic     analysis was studied by polymerase chain reaction-restriction fragment length polymorphism     technique.   "
36706|NCT02805218|"     The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients     with lymphoma receiving chemotherapy.   "
36707|NCT02805205|"     The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients     with breast cancer receiving chemotherapy.   "
36710|NCT02805166|"     The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients     with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving     multi-cycle chemotherapy.   "
36711|NCT02805153|"     The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients     with breast cancer receiving chemotherapy   "
36716|NCT02805088|"     The initial aim of the project was to gain an understanding of the comprehension of     language-oriented emotions among schizophrenic and bipolar patients. By language-oriented     emotions, the investigators mean the emotions that are conveyed by means of language, whether     through the emotional valence of the words, the expression of an emotional state or emotional     prosody. Although they involve different diagnostic categories, schizophrenic and bipolar     disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and     do so to such an extent that the question of whether there may, at the clinical, cognitive     and etiopathogenic levels, exist a continuum between these disorders is frequently raised.     Taking this hypothesis of a clinical continuum as our starting point, the investigators     explored the understanding of emotions contextualized by language in these two clinical     populations, namely patients exhibiting schizophrenic and bipolar disorders. To these     populations, the investigators also added the dimension of vulnerability in the form of     non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus     orienting this project toward the early identification of cognitive-emotional markers and     possibly also their prevention.   "
36717|NCT02805075|"     This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in     treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes     the transplanted cells from a donor can make an immune response against the body's normal     cells (called graft-versus-host disease). Nutritional supplements such as     fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients with     blood cancer undergoing donor stem cell transplant.   "
36718|NCT02805062|"     Malignant pleural effusion is a common clinical problem with median survival of approximately     6 months thus efficient management of Malignant pleural effusion is important. In patients     with a Trapped Lung, pleurodesis will be unsuccessful and an indwelling pleural catheter     should be inserted instead. Accurate detection of Trapped Lung prior to insertion would avoid     futile attempts at talc pleurodesis, re-intervention following failed pleurodesis and allow     adequate time to plan for an indwelling pleural catheter insertion.Pleural manometry allows     direct and objective measurement of intra-pleural pressure during pleural fluid     aspiration.The primary aim of this study is to determine whether the addition of digital     pleural manometry to clinical judgment, prior to and during local anaesthetic thoracoscopy,     results in a clinically meaningful improvement in Trapped Lung detection.   "
36719|NCT02805049|"     The main objective of this study is to describe the pharmacokinetics of the prescribed     echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal     infection is suspected or proven.   "
36720|NCT02805036|"     Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar     recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for     decreasing morbidity associated with mechanical ventilation.      In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from     one centre to another and from one study to another.      The investigators intend to compare two currently used AR techniques with regard to their     ventilatory efficacy and hemodynamic safety:        -  An end-tidal plateau at 30 cmH20 for 30 seconds.        -  An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds,          without exceeding 30 cmH20.   "
36721|NCT02805023|"     Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells     enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic     stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from peripheral     arterial disease (PAD) with critical limb ischemia (CLI) who have not responded to optimal     pharmacological treatment or control of risk factors and/or had a revascularization failure,     and do not have the option of further revascularization treatment.   "
36722|NCT02805010|"     The objective of the study is to assess the single dose PK, safety, tolerability and     immunogenicity of abatacept 125mg administered SC in Chinese healthy subjects.   "
36723|NCT02804997|"     The great majority of cardiac surgery patients develop a degree of post-operatory respiratory     failure. This is due to several factors. The predominant element in the onset of this     respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by     peroperative hypoventilation (in the presence or absence of ECC). The incidence has been     evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive     ventilation) might (through the application of continuous positive expiratory pressure) help     to counter the development of these atelectasic foci.   "
36724|NCT02804984|"     The project's objective is to identify and characterize somatic mutations in cases of     idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects     found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS may     be a precursor of MDS. To this end, high-throughput exon sequencing (using next-generation     sequencing (NGS)) will be used to target the genes known to be mutated in MDS. This study is     important for two reasons. Firstly, it will help to optimise the clinical monitoring of     patients with molecular defects and considered to be at risk of progression. Secondly, it     will provide a better understanding of the fundamental molecular mechanisms underlying the     progression of ICUS to MDS.   "
36734|NCT02804854|"     Critically ill patients often succumb to acute respiratory disease (rapidly developing     disease affecting the lungs). The lungs are the commonest organ to fail and require support     in the intensive care environment. However, no accurate methods exist that can be used at the     bedside to tell what is causing deterioration in a person's lungs. There are various examples     of acute respiratory diseases that can occur as a result of numerous different causes, have a     high risk of death and cannot be treated easily with drugs. When trying to accurately     diagnose and classify these lung diseases there is a risk that the type of respiratory     disease is misdiagnosed, missed or the level of severity is not captured. By using the field     of optical molecular imaging and employing novel techniques and technologies, the     investigators hope to demonstrate here that a bespoke chemical probe administered in micro     doses (tiny doses) directly into the distal lung can rapidly and accurately detect activated     neutrophils (cells of the immune system that are implicated in the development of these     severe conditions), and so work towards a bedside test which could be used to diagnose,     monitor and classify the disease in patients who are critically ill in the future. The     population for this study are in intensive care where patients are normally intubated (have a     breathing tube) due to the severity of their illness, this may be because of respiratory     problems or respiratory problems can rapidly develop. Participants will have the chemical     probe administered into their lungs and pictures taken through the tube already in place. As     this probe lights up when it comes into contact with neutrophils the investigators will be     able to tell if neutrophils are present. This will inform a larger study in which it's hoped     that the method can be used to inform clinical decisions. The first procedure will take place     within two days of initiation of mechanical ventilation and the direct contact with the study     team will be completed within nine days.   "
36725|NCT02804971|"     Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with     inflammation, which leads to a progressive lung deterioration. This disease is responsible     for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of     hospitalization. Natural history is marked by recurrent infectious diseases which are the     main prognosis factor. This disease is associated with an inflammation rate in the lung as     well as in the blood. Up to now, no study has been described comorbidities associated with     this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent     in these patients. In fact systemic inflammation driven by bronchial infections may increase     frequency of cardiovascular diseases.      The investigators decide to conduct a monocentric observational study to define the     prevalence and characterization of cardiovascular comorbidities as well as markers of     accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are     frequent in bronchiectasis and may be associated with markers of inflammation and aging.      Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement     according to the ATS/ERS guideline. 6M walking test and echocardiography will be also     performed.      Frequency of comorbidities will be calculated with data from questionnaire as well as     standardized explorations.      Aging related manifestations will be measured: arterial stiffness using aortic pulse wave     velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal     muscle mass and grip test were also performed.      Blood test were also performed to measure inflammatory markers, cytokines and length of     telomere in circulating leucocytes.   "
36726|NCT02804958|"     INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for     acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective,     observational, 4-regional-hospital based registry reflecting current practices of management,     risk factors, and clinical outcomes in patients with ST-segment elevation myocardial     infarction undergoing primary percutaneous coronary intervention at cities of Incheon and     Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014.   "
36727|NCT02804945|"     The goal of this clinical research study is to learn about the safety of giving mesenchymal     stem cells (MSCs) to patients who have ARDS. Researchers also want to learn if these cells     can help control ARDS when given with drugs that are routinely used to treat ARDS.      In this study, all participants will receive standard of care treatment for ARDs, and some     participants will receive standard of care treatment and MSCs.   "
36728|NCT02804932|"     The purpose of this study is to use a randomized, double-blind, placebo controlled study     design to comprehensively investigate the impact of 8-weeks of dietary nitrate     supplementation on skeletal muscle blood flow, mitochondrial function, and exercise capacity     in patients with type 2 diabetes (T2D).   "
36730|NCT02804906|"     This pilot feasibility study will test whether a home-based cardiac rehabilitation     intervention, using physical therapist visits combined with mobile health technology, will     prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants     will be randomized to either an intervention arm (home-based physical therapy), or a control     (usual care) arm. Prior to discharge, participants in the intervention arm will receive a     1-hour educational session by a research physical therapist that includes information on     cardiac risk factor management, postoperative recovery, education on medication adherence,     and a prescription for home exercise that is tailored to each patient's baseline abilities     and limitations. Participants assigned to the control arm will receive a 30-minute counseling     session on risk factor modification prior to discharge, in addition to usual care post-AMI.   "
36731|NCT02804893|"     This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies     and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected     recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major     lung resections performed using one of the two techniques for participation in the study.     Each participating centers should have the possibility to offer both techniques (Robotics and     Vats). The primary end point is a combination of conversion and complication rate. The     presence of at least one of the two events is considered a failure. Considering the rate of     failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm,     so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.   "
36732|NCT02804880|"     The present study will examine (1) the effectiveness of personalised active referral to     smoking cessation (SC) services and text messaging on encouraging SC services (2) explore the     use of CBPR model to build capacity and to engage community partners in taking on this     important public health issue for sustainability in the community. In addition, process     evaluation will be conducted to assess the effectiveness of the recruitment activity and how     it is linked with the overall program outcomes.   "
36733|NCT02804867|"     This study aims to identify signs of depression and bipolar disorder by measuring changes of     certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use     these biomarkers to develop a diagnostic test to enable early treatment, which can lead to     better patient outcomes.   "
36735|NCT02804841|"     Ireland is predicted to have the highest older adult population growth of any European Union     country. A substantial economic and social challenge of this projected growth is the     increased incidence of cognitive impairment and the likelihood of progression to dementia.     Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain     changes identifiable from the earliest stages of neuropathology, providing an opportunity for     intervention. Switching to a strategy of earlier identification and prevention would     significantly reduce prevalence and the associated cost.      The purpose of this pilot study is to evaluate the use of vitamin D supplements in community     dwelling older adults as a lifestyle approach that may support cognitive and physical     functioning. The research will incorporate several stages including an initial in-depth     screening process, a novel and sensitive cognitive battery, 6 month double blind placebo     controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant feedback     interview.      These results will be used to assess the feasibility of recruiting and assessing community     dwelling older adults for extensive nutrition related cognitive studies.   "
36737|NCT02804815|"     Add-Aspirin aims to assess whether regular aspirin use after standard curative therapy can     prevent recurrence and improve survival in individuals with non-metastatic common tumours.     The question will be assessed in four different tumour types (breast, colorectal,     gastro-oesophageal and prostate) by means of parallel cohorts within an overarching trial     protocol.      Eligible participants will be randomly assigned (double-blind) to either aspirin 100mg,     aspirin 300mg or a matched placebo, to be taken daily for at least 5 years. Disease     recurrence and survival will be assessed, along with adherence, toxicity, and other potential     effects of aspirin (eg. cardiovascular).      There is a large body of evidence indicating that aspirin has anti-cancer effects.     Meta-analyses of cardiovascular trials of aspirin have shown short-term effects on cancer     mortality and a decrease in risk of metastases, suggesting a role for aspirin in the     treatment as well as prevention of cancer. Additionally, large observational studies of     individuals taking aspirin after cancer treatment have shown improved disease-specific and     overall mortality for specific tumour types.      In the treatment setting, the risks of side effects associated with aspirin are expected to     be outweighed by potential benefits. However, this has not yet been assessed in a randomised     trial.      As a low cost, generic and widely available drug, which is generally safe, if aspirin is     shown to be effective, it could have a huge impact on cancer outcomes globally.   "
36738|NCT02804802|"     The main purpose of our project is to construct a lifestyle score based on a short     questionnaire easy to complete and to validate it among participants in mass screening for     colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). We     will evaluate the ability of our score to identify subjects with colorectal cancer diagnosed     by the screening procedure (Hemoccult II ®, and colonoscopy if the test result is positive).     Colorectal cancer will be the primary outcome for the assessment of the score's performance.     The secondary endpoint will focus on colorectal adenomas diagnosed by the same procedure. Our     secondary objectives are to test a second weighting system, evaluate the benefit in terms of     predictive performance to add to the lifestyle score other dietary factors among that have a     probable link with the risk of colorectal cancer, determine the acceptability of the     questionnaire and to estimate by a cost-utility analysis the impact of applying a strategy of     targeted screening using the developed score.   "
36753|NCT02804607|"     Traumatic skin lesions and in particular the burns which happen to growing children are     complex and require an adapted and early patient care management. A child presents physical,     psychological, and physiological characteristics which involve a specific functional     prognosis. The aim of the study was to evaluate the functional outcome after a mid-term     period from a severe skin traumatism occurring during childhood and which had required an     initial graft.   "
37194|NCT02798835|"     This study investigates single injection adductor canal block (ACB) with or without     intravenous dexamethasone and adductor canal catheter for pain management of total knee     arthroplasty. This is a non-inferiority trial seeking to determine whether single injection     ACB with dexamethasone is no worse than a continuous catheter.   "
36739|NCT02804789|"     Brain changes associated with Alzheimer's disease may precede symptoms of Alzheimer's     Dementia by over 20 years. The Investigators hope to be able to identify Alzheimer's disease     at its very earliest stages when in theory treatments are most likely to be successful in     preventing further spread of the disease in the brain and causing dementia. The aim of EPAD     programme is to develop new treatments more quickly to prevent Alzheimer's dementia. A major     component of the EPAD programme is the EPAD Longitudinal Cohort Study which can provide     subjects for the EPAD trial as well as data to improve understanding of disease before     dementia develops.      The Investigators will approach a broad range of people over the age of 50 who have     previously taken part in various research studies and consented to being recontacted for     further research. Participants will be asked questions to assess their memory and other     cognitive function. The participants will also undertake a brain scan, provide a sample of     spinal fluid, blood, urine and saliva to look at markers in these bodily fluids that may     change in Alzheimer's disease. The Investigators will then follow these participants until     December 2019 repeating these tests annually. This will be called the EPAD Longitudinal     Cohort Study (EPAD LCS). The main reasons for EPAD developing a cohort are to help the     Investigators understand more about what happens to people before dementia develops, and to     help recruit people more quickly into the EPAD trials of new medications or other     interventions expected to prevent dementia.      People in the EPAD LCS may be invited to take part in the EPAD Proof of Concept prevention     studies to see if interventions can modify the probability of developing dementia or     cognitive problems (this will be subject to separate ethics approval and consent). Together     EPAD LCS and EPAD PoC make up the full EPAD Programme.   "
36740|NCT02804776|"     This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for     patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation     lung cancer.   "
36741|NCT02804763|"     The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab     Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic     Lupus Erythematosus receiving stable standard-of-care medications.   "
36742|NCT02804750|"     Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels     of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated     endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from     cortisol overproduction by the adrenal glands is the subject of this protocol.      Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic     administration of high doses of glucocorticoids, are not eligible for enrollment in this     study.      The purpose of this study is to evaluate the safety and efficacy of CORT125134 for treatment     of endogenous Cushing's syndrome. The multicenter study will be conducted in the United     States and in Europe.   "
36743|NCT02804737|"     The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used     web-based instructions at St. Paul's Hospital.   "
36744|NCT02804724|"     Human immunodeficiency virus (HIV) is a major global health concern which has resulted in an     estimated 39 million deaths world-wide. Although it is now a treatable medical condition     there is still avoidable morbidity and mortality associated with HIV infection in the UK.     Late diagnosis (CD4 count of <350 cells/mm3 or AIDS-defining illness irrespective of CD4     count) is associated with increased morbidity and mortality, increased risk of transmission,     impaired response to antiretroviral therapy and increased healthcare costs. In Grampian, 49%     of patients were diagnosed late between 1984 and 2011. Therefore, the aim of the study is to     determine the factors associated with late HIV diagnosis in Grampian between 2009 and 2014 to     ascertain whether diagnoses could have been made earlier.      The study constitutes a secondary data analysis. Individuals newly diagnosed with HIV between     January 2009 and December 2014 were identified from a Health Protection Scotland (HPS)     database. The majority of outcome data were extracted from the existing HPS database. Missing     data were collected via a retrospective review of patient case-notes, laboratory reports and     an electronic patient management system. Patients were classified as early or late diagnosis     and comparisons were made between the groups using statistical tests. The study sought to     provide a basis for recommendations for improvement of information and services to facilitate     earlier HIV diagnosis in Grampian.   "
36766|NCT02804438|"     The purpose of this study is to collect a large amount of data that may assist in addressing     the gap in knowledge of understanding pupillometer readings using a pupillometer device.      The aim of this project is to establish normative values for pupillometer data. Measures of     central tendency will be developed for the variables provided by automated pupillary exams,     which will provide an enhanced understanding of clinically appropriate pupil values for size,     reactivity, and neurological pupil index.   "
36745|NCT02804711|"     Before this study, there will be an open-label, dose-escalation pilot study with a total of     30 participants with 10 per dosage group. The aim of the pilot study is to explore the     preliminary safety of an experimental recombinant staphylococcus aureus vaccine.      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical     trial. This study will determine the safety and side-effect profile, and immunogenicity of an     experimental recombinant staphylococcus aureus vaccine. The study will be carried out     following a dose-escalation method from the low dosage to the high dosage, i.e. the higher     dosage vaccine could only be administrated after the first seven-day safety of the lower     dosage vaccine is confirmed after safety observation.   "
36746|NCT02804698|"     This project will look to improve standards of care for diabetic patients by evaluating a     program that supports participants in making healthy lifestyle changes.      The program consists of 13 educational sessions that contain information about the prevention     and care of diabetes and cardiovascular disease, physical activity, nutrition, community     health and emotional well being.   "
36747|NCT02804685|"     This research presents a randomized clinical trial which evaluates the effectiveness of an     exercise protocol on the knee-joint repositioning in futsal players related to a post-match     muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position     before and after the match when performing our exercise program.   "
36748|NCT02804672|"     The purpose of this study is to examine the association between ideal cardiovascular health,     diet and other lifestyles, biological risk factors, either well-established or emergent, and     the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).   "
36749|NCT02804659|"     Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid status.   "
36750|NCT02804646|"     The purpose of this study is to discuss the efficacy and safety of recombinant human     endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus cisplatin     or carboplatin in the first-line treatment of advanced lung adenocarcinoma with wild-type     EGFR or ALK-negative,compared with chemotherapy without endostar.   "
36751|NCT02804633|"     The investigators hypothesis is that use of IV acetaminophen will significantly decrease use     of post-operative opioid consumption and enhances recovery after colorectal surgery.   "
36754|NCT02804594|"     This is a 4-week randomized, placebo-controlled, parallel group, double-blind, single center     trial on effect of N-acetyl cysteine versus placebo on fatigue in patients with progressive     MS defined by McDonald criteria. Subjects who enter the treatment phase of study, will be     randomly assigned to either N-acetyl cysteine (1250 mg three times a day) or placebo (three     times a day) for 4 weeks. There will be 3 in-person study visits (screening, baseline, and     week 4) and 2 visits over the phone (week 2, and week 6 which is 2 weeks after completing     last study drug dose). Visits will all occur in the morning to maximize consistency of     assessments and evaluate main outcomes within 2 hours of morning dose of study medication.     Fatigue questionnaires, and research samples will be obtained before neurological     examination, or magnetic resonance imaging. Research blood draws will be obtained just after     fatigue questionnaire completion. Brain spectroscopy will be obtained less than 2 hours after     morning dose of study drug to maximize detection of the biological effect of study     medication.   "
36755|NCT02804581|"     Gum Arabic (GA) rich dietary fiber it is a water-soluble dietary fiber derived from the dried     gummy exudates of the stems and branches of Acacia senegal, GA found to have strong immuno     modulator in vitro where it increased IL10 production showing strong anti-inflammatory     effects (19).      The aim of this study is to determine the role of gum Arabic in immunomodulation among     patients with rheumatoid arthritis.   "
36756|NCT02804568|"     This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine     and samidorphan in adults with schizophrenia following 14 consecutive days of oral     administration of ALKS 3831.   "
36757|NCT02804555|"     In this study the investigators examine the effects of intraoperative oxygen administration     to the mother on certain enzyme functions of the newborn. With this object blood samples are     taken from the newborn's umbilical chord - which is otherwise a routine practice at the     investigators clinic - and the mother's radial artery in parallel with umbilical clamping and     cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a     properly equipped laboratory.   "
36758|NCT02804542|"     The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca     blocks performed in the emergency department are effective for preoperative analgesia in hip     fracture patients. Investigators hypothesize that patients with these blocks will have lower     opioid requirements than patients in a historical group in whom blocks were not performed.   "
36759|NCT02804529|"     The Palmer's point and periumbilical region are the common laparoscopic entry site to     establish the pneumoperitoneum. In the present study, the investigators assess the safety and     feasibility of Meng's point as a new laparoscopic entry site in cases to perform the     gastrointestinal surgery.      This prospective and randomized study will compare the three entry techniques with regard to:        -  Complications related to the entry technique        -  Time taken to enter the abdomen.        -  The number of attempts taken to enter the abdomen   "
36760|NCT02804516|"     Despite evidence to support early mobilization（EM）for critically ill patients,current status     in Chinese ICUs is unknown.Understanding current practice patterns and challenges is     essential to inform future research and strategies.   "
36767|NCT02804425|"     The use of simulation in medical education has been associated with positive results in the     acquisition of knowledge, skills, behaviors and in patient outcome. According to Kolb et al,     high-fidelity simulation provides concrete experience that is the basis for self-reflection,     further experimentation and immersive learning named experiential learning. However the     important number of learners and the extensive human resources required to deliver mannequin     patient-based simulation limit its use for initial and repeated training. In general, 2-4     trainees participate in each scenario while others may look at the progress of the scene     through video transmission in a neighboring room while all trainees met thereafter for the     debriefing. In typical learning sessions, all trainees act as a participant at least once.     However, due to the increasing number of trainees, the investigators anticipate that some     trainees might remain spectators during the whole simulation session.      In our simulation unit (LabForSIMS- Faculté de Médecine Paris Sud), a simulation session for     all third to forth year anesthesia residents (PGY3-4) of Ile de France has been established a     few years ago. Each session includes a one-day training with 4 different immersive scenarios     using a high fidelity mannequin. Each scenario is attended by 3 residents. In years before     2014, the number of anesthesia residents to be trained was 35 and each of them could play the     role of an actor at least once in the session (actor-spectator). In a previous preliminary     study, the investigators found that the learning outcomes were similar for all residents at     the end of the day, whatever the scenario in which they had played and those scenarios for     which they had remained spectators. This led to the hypothesis that being an actor in a     scenario might be less important than attending the whole session and participating in all     debriefings. However, to our knowledge, few study has explored the outcomes of the learning     process for spectators-only.      The number of residents sharply increased to 110 from 2014 to 2016. Due to time constraints     and limitation in the number of trained teachers, the investigators see that inevitably,     several trainees will remain spectators during the whole session. The purpose of this study     is thus to determine whether the status of the learner (actor-spectator vs spectator-only)     during an immersive simulation has an impact of learning outcomes.   "
36768|NCT02804412|"     Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has     remained unclear, however, whether intensity of therapy or constraint is the relevant factor.     This study will give an answer to this question to improve speech and language therapy.   "
36769|NCT02804399|"     The purpose of this study is to estimate the effect of rifampin on the single dose PK of     PF-06463922.   "
36770|NCT02804386|"     Title Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin with or without Interferon     among Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of     Sofosbuvir (HEATS) Study Design Endpoint Classification: Safety/Efficacy Study Intervention     Model: Treatment agents (non-interventional observational study): Real life clinical practice     study Masking: Open Label Primary Purpose: Treatment Duration Around 12 Months Study Centre     Multi centric Study   "
36771|NCT02804373|"     The investigator thinks that the oxytocin (OT) can improve durably and significantly the     behavior disorders and thus the socialization but also the satisfaction and could thus be an     interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome     (SPW). Although today several studies demonstrated the effects of the OT in various domains     of the behavior, the investigator do not know either its specificity of action about the     cerebral level, or its duration of action, or the optimal modalities of administration and in     particular at patients SPW.   "
36823|NCT02803697|"     Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their     growth is usually slow and diagnosis is often made in the context of masse effect .The     therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic     radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an     individualized follow-up and recurrence could happen 10 or 15 years after the first surgery.     In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find     predictive factors of recurrence to personalized the follow-up of each patient.   "
36772|NCT02804360|"     Purpose: Cystoid macular edema (CME) in retinitis pigmentosa (RP) has been managed in several     ways with little success. The aim of our study was to report the use of intravitreal     dexamethasone implant in a large series of patients with RP and CME.      Setting: Retrospective case series. Methods: Cases were diagnosed as RP based on the classic     fundus triad of bone-spicule pigment deposits (intraretinal pigmentary migration), retinal     vessel attenuation, waxy pallor of the optic disc along with night blindness and attenuated     ERG amplitudes (delays in rod or cone b-wave implicit times). Family history of RP and family     screening for RP were important in establishing the diagnosis in eyes with some diagnostic     challenge. CME was diagnosed by intravitreous fluorescein angiography IVFA and spectral     domain optical coherence tomography (SD-OCT). BCVA was monitored using Snellen visual acuity     chart and CME was monitored by SD-OCT on follow-up visits.   "
36773|NCT02804347|"     The sense of smell and cognition are known to be closely associated with mood and emotional     processes. However, despite the clear links between olfaction and cognitive processes with     emotional states, research into the role of olfaction, cognition, and mood disorders has so     far yielded variable results. This study proposes to investigate the ability to detect and     identify odours and assess cognition in a group of patients with unipolar and bipolar     depression prior to and after receiving their scheduled electroconvulsive therapy (ECT) or     intermittent theta burst stimulation (iTBS) treatments. Olfaction will be evaluated utilizing     standard olfactory testing protocols using commercially available kits. Cognition will be     evaluated utilizing standard cognitive test protocols in a functional magnetic resonance     imaging protocol. The results will potentially shed light on the link between olfaction,     cognition and mood disorders.   "
36774|NCT02804334|"     The goal of this project is to study ~45 molecules in blood cells that may differentiate     patients with bipolar disorder from healthy controls.   "
36775|NCT02804321|"     Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing     prevalence. Two main techniques are used today to restore sinus rhythm: electrical     cardioversion and radiofrequency ablation.      Radiofrequency ablation has become a recognized and effective treatment of AF. Despite a     relatively high success rate (about 80%), a substantial number of patients require a second     procedure to obtain sinus rhythm. Many publications have led to the study of predictors of     failure of this ablation factors (BMI, uncontrolled hypertension, size of the OG...) but to     date no parameter is reliable and usable in daily practice.      It is the same for electrical cardioversion. Despite a relatively high immediate success rate     of approximately 80%, a significant number of patient relapse arrhythmia in short and long     term. Many publications have led to the study of predictive factors of failure (seniority and     type of AF, uncontrolled hypertension, size of the OG, mitral valve disease...) but so far     the results are disappointing.      In AF patients with heart disease underlying, it has been well demonstrated that the     renin-angiotensin system (RAAS) was strongly activated. In addition, it is now well     established that elevated plasma aldosterone as in primary hyperaldosteronism is associated     with a significantly increased risk of occurrence of cardiovascular events. The high plasma     concentrations were also highlighted in the acute phase of myocardial infarction, or heart     failure and are associated with an increase in major cardiovascular event rate, especially     arrhythmias. In some experimental models of heart failure, it has been demonstrated a     suppression of the occurrence of spontaneous FA by an anti-aldosterone treatment. The     arrhythmogenic effect of aldosterone has also been shown in animal models. All these results     indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and     the FA.      The hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is     predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias     (flutter or atrial tachycardia) after FA reduction, either in using a radiofrequency ablation     or via electrical cardioversion.   "
36776|NCT02804308|"     Breast cancer is a multifactorial disease affecting women, and one of the treatments for its     healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that     promote lower chance of metastasis, but their side effects include the loss of bone mineral     density and increased fat percentage. In this way, the Combined Training (combined resistance     and endurance training) may be an interesting strategy to minimize the side effects of     aromatase inhibitors, providing better quality of life, survival and changes in body     composition.   "
36777|NCT02804295|"     Injured trauma patients in the Emergency Department (ED) may be a particularly important     group to target for screening and intervention for prescription drug misuse (PDM). These     patients have high rates of psychiatric and substance use co-morbidity and pain management     for their injuries (e.g. broken bones, burns) will often require prescribed opioid pain     medications and other controlled substances. To date, there are no effective ED-based     interventions for PDM. Collaborative Care is a longitudinal model of care that combines     multiple elements for patients with complex medical comorbidities. This model holds promise     as an intervention strategy for injured patients in the ED that are at risk for prescription     drug misuses. Collaborative Care from the ED is innovative and requires developing follow up     procedures on a population that has previously been difficult to follow and may have     previously avoided consistent health care delivery. The primary objective of this study was     to determine the feasibility of initiating a collaborative care intervention for injured ED     patients with PDM by enrolling patients into an open trial of this intervention. A secondary     objective was to determine if PDM decreases over time after enrollment and developing     successful follow-up procedures to deliver longitudinal care.   "
36778|NCT02804282|"     The proposed single-dose study aims to evaluate the product design clinical performance of     the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination     Product, in adult Subjects previously diagnosed with mild to advanced heart failure.      The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose     equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the     sc2Wear Furosemide Pump adhered to the body using medical grade adhesive.      The objectives of this study are:        -  To demonstrate that the to-be-marketed drug-device combination product performs as          intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area        -  To assess safety and local tolerance of the drug-device combination product   "
36779|NCT02804269|"     Biobank is a program which collects biological samples, health information and imaging data     from consented patients and stored them at the core facility. These information would be used     to study the molecular, imaging and outcome studies of cardiovascular health and disease.   "
36851|NCT02803333|"     The Moffitt Cancer Center and PatientsLikeMe.com (PLM), an online patient community, are     working together to better understand the patient's entire lung cancer experience, both     inside and outside the doctor's office. By combining the data that is captured by their care     team in the clinic with the data participants enter at their home on PatientsLikeMe.com, the     investigators hope to improve patient-physician treatment decisions, so that the patient's     personal treatment goals and quality of life have the highest chances of being fulfilled.   "
36780|NCT02804256|"     The National Heart Centre Singapore has recently created a biorepository that is IRB approved     for the use in genetic studies: molecular and imaging studies of cardiovascular health and     disease (CIRB Ref: 2013/605/C). This repository enables IRB approved projects within the     National Heart Centre Singapore to access the samples for use in biomarker or genetic studies     with consent from patients for these studies. The IRB approved biorepository process also     allows for patients, when they have consented to this, to be approached for inclusion in     additional studies at National Heart Centre Singapore.      In this study, the investigators will examine the genetic variation in genes known to cause     inherited cardiac conditions and also look for circulating biomarkers (ICC) in 600 patients     with ICC and in 500 patients with ischemic heart disease (e.g.IHD) who will be used as     controls. Healthy controls will also be used (800) as they become available in the     biorepository. All samples have already been collected in the NHCS biorepository.      These patients would have been recruited and consented to the biorepository. This will enable     all to better understand heart disease in Singaporean patients. In addition, the     investigators will invite a subset of 10 patients with ICCs to provide a second blood sample     (20mls - 2 tablespoons) on top of the samples that will be collected for the biorepository.     The second blood sample will be used for antibody biomarkers that will be developed in the     basic science laboratories. These antibodies will be used to develop new biomarkers of human     heart disease to improve human health.   "
36781|NCT02804243|"     The purpose of this study is to compare the exercise endurance between oxygen therapy with     rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic     respiratory failure receiving long-term oxygen therapy.   "
36782|NCT02804230|"     The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness     of ExAblate thermal ablation of a subcortical focal epileptic target area in the brain of     patients suffering from medication-refractory epilepsy, using the ExAblate transcranial     system to produce multiple sonications targeted in the lesion of interest. The investigators     will establish the feasibility and collect data to establish the basic safety of this type of     treatment as the basis for later studies that will evaluate its full clinical efficacy.   "
36783|NCT02804217|"     Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial     growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR     tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be     helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile     of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next     generation sequencing (NGS).   "
36784|NCT02804204|"     Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor,     cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors     in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24     weeks of treatment.   "
36785|NCT02804191|"     A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to     Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe     Conjunctivochalasis   "
36786|NCT02804178|"     This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and     efficacy of orally administered ATR-101 in subjects with classic congenital adrenal     hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to     6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of     5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.   "
36787|NCT02804165|"     Type 1 diabetes (T1D) is the most common endocrine disorder in children. In France, T1D     prevalence is estimated to 12.2 per 100 000. Worldwide T1D incidence increased rapidly in the     last decades, around 3% per year. T1D is caused by autoimmune destruction of pancreatic beta     cells, leading to hyperglycaemia. T1D was recently associated an important loss in life     expectancy compared with the general population. To date, the precise aetiology of T1D onset     and the mechanisms involved in T1D remain unknown and no preventive treatment of T1D exists.      It is now well admitted that T1D results from a combined effect of genes, environmental     factors and gene-environment interactions. Several genetic factors have been reported as     associated to T1D, the most important being the human leukocyte antigen class II genes. Whole     genome association studies suggested more than 50 T1D other susceptibility locus, but     conferring individually a modest risk to develop T1D. Longitudinal studies demonstrated that     only a low fraction of genetically predisposed subjects develop T1D and all these genetic     factors cannot explain the increase in prevalence of T1D in the latter half of the 20th     century, suggesting the implication of environmental factors.      Literature has accumulated a lot of evidence for the role of enterovirus in T1D. Several     retrospective, prospective, post-mortem human studies, as well as animal studies, strongly     suggest contribution of human enteroviruses to the pathogenesis of T1D. Enterovirus probably     play a dual role in T1D, some enterovirus being associated with an increased risk of T1D and     others with a protective effect. Interestingly, several T1D susceptibility loci are     implicated in antiviral response. Epidemiologic and genetic approaches have led to new     insights into T1D causation, but a collective explanation is still lacking.      The project aims at (1) demonstrating the gene-enterovirus interaction effect on T1D onset     and (2) characterizing the precipitating effect of enterovirus on T1D by a follow-up study     of T1D high-risk subjects (first degree unaffected relatives with positive autoantibodies to     islet antigens).      A structural originality of this project is to perform a family-based study of     gene-enterovirus interaction in T1D using innovative and robust methods. This project will be     conducted in close collaboration between our INSERM unit, the Inter-regional network of     paediatric diabetology, labelled biobanks (CBC Biotec of Hospices Civils de Lyon and CRB-LRB     of Lariboisière' hospital at Paris), the Centre National de Référence des Enterovirus at Lyon     and the Centre National de Génotypage at Evry.      The investigators will first conduct a 3-years pilot study (2016-2019), based on a sample of     250 nuclear families ascertained through a paediatric T1D proband in four centres. Families     will be ascertained during the hospitalization of the proband at the time of T1D diagnosis.     The study will be then extended to whole Inter-regional network of paediatric diabetology.      This research is a unique opportunity to explore further the implication of enterovirus and     their interactions with genetic factors involved in T1D susceptibility and aims to target     high-risk T1D subjects. This innovative project opens the door of the development of     preventive therapy for T1D.   "
36788|NCT02804152|"     Pregnant women using prescription opioid medication (pain medications) are invited to take     part in a program for the reduction of pain and prescription opioid misuse.   "
36801|NCT02803983|"     The purpose of this study is to compare the early postoperative radiologic and clinical     outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck     fracture (Delbet type II and Delbet type III).   "
36802|NCT02803970|"     The aim of this study is to collect data on Korean patients with borderline ovarian tumors.   "
36789|NCT02804139|"     The purpose of this study is to determine whether a physical therapy program which includes     scar management, core retraining, and lumbar and pelvic joint mobilization will significantly     impact the postpartum recovery following Cesarean section during the immediate postpartum     period and during the first 1.5 years following childbirth.      All patients who enroll in the study will receive standard treatment following a C-section     delivery. Subjects will be randomized into one of two groups; one group will receive physical     therapy in addition to standard post C-section treatment, and the other group will receive     standard post C-section treatment with no additional physical therapy. Both groups will     complete questionnaires regarding their pain and recovery from C-section delivery to     determine if there is a difference in recovery between the group receiving physical therapy     and the group not receiving physical therapy.   "
36790|NCT02804126|"     Comparison of two types of analgesia after cesarean section.      All patients will anaesthetised with spinal technique. Ultrasound-guided transversus     abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain     will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient     will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).   "
36791|NCT02804113|"     The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common     femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The     lesion is located within the native CFA and treated with predillation prior to stenting with     the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6     and 12 month post procedure. The primary endpoint of the study is the primary patency at 12     months and periprocedural events up to 30 days post procedure. Secondary endpoints include     technical success, primary patency rate at 1 & 6 month, freedom from TLR at 1-, 6- and 12     month follow-up and clinical success at 1-, 6- & 12-month follow-up.   "
36792|NCT02804100|"     A multi-centre observational, non-interventional study is to dynamically monitor the changes     of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.   "
36793|NCT02804087|"     To evaluate the safety and performance of the MobiusHD system in subjects with resistant     hypertension.   "
36794|NCT02804074|"     MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study (PROBE)     comparing 2 management strategies 1) office BP as a guide to treatment, or 2) 24-hour ABP as     a guide to treatment. Study objectives are to investigate whether a management strategy based     on out-of-office BP (Ambulatory BP monitoring) versus a management strategy based on office     BP measurements is associated with differences in outcome, including cardiovascular and renal     intermediate end points at one year; cardiovascular events at 4 years and changes in a number     of blood pressure-related variables throughout the study. Patients will be followed-up during     the first year focusing on changes in left ventricular mass index (LVMI, co-primary endpoint)     and Urinary albumin excretion (UAE, albumin/creatinine ratio, co-primary end-point), and     during the whole 48 month period for both changes in LVMI and UAE and events including     all-cause mortality, CV morbidity and mortality, cerebral morbidity and mortality.A total of     1240 subjects will be recruited by 30 centers, taking into account a dropout rate of 15% (620     subjects per randomization arm).   "
36795|NCT02804061|"     Nutrition and exercise behaviour change programs can prevent excessive gestational weight     gain (EGWG). The Nutrition and Exercise Lifestyle Intervention Program (NELIP) is a     previously published two-behaviour change program which was successful in preventing EGWG     across normal weight, overweight and obese pre-pregnancy body mass index (BMI) categories     (Ruchat et al. 2012; Mottola et al. 2010), however some women found it difficult to adhere to     two lifestyle behaviour changes throughout pregnancy. The proposed pilot randomized     controlled trial will address the issue of adherence by identifying the best way to offer a     two-behaviour change program (NELIP) to pregnant women to increase the effectiveness of     preventing early and total EGWG. Participants will begin the program at <18 weeks gestation     and will be randomized to one of three groups: A) Receive both behaviour changes (Nutrition     AND Exercise) simultaneously at entrance to the study; B) Receive the nutrition component     first followed sequentially by the introduction of exercise at 25 weeks gestation (Nutrition     FOLLOWED by Exercise); C) Receive the exercise component first followed sequentially by the     introduction of the nutrition component at 25 weeks gestation (Exercise FOLLOWED by     Nutrition).   "
36796|NCT02804048|"     Aim: To evaluate the effectiveness of physical therapy intervention techniques in the     improvement of dyspareunia in climacteric women.      Study design: This is a randomized controlled trial.   "
36797|NCT02804035|"     The proposed pilot study aims to gain experience with the first clinical use of the to-be     marketed drug-device combination product, the sc2Wear Furosemide Combination Product and to     assess methods and procedures for evaluation of product performance.      The objectives of this study are:        -  To gain first in man experience of a novel drug-device combination product        -  To evaluate the suitability of the methods and procedures for evaluating of the          performance of the sc2Wear Pump   "
36798|NCT02804022|"     This is a closed-loop system which is embodied in a novel and intelligent algorithm that     takes into account patients' vital signs. The system allows better and responsive titration     of personalized pain relief together with non-invasive physiological monitoring that measures     oxygenation, breathing and heart rate continuously.   "
36799|NCT02804009|"     Anxiety will be assessed from two aspects, the somatic and emotional. ANGST aims to determine     how anxiety correlates with psychological parameters (personality traits, coping strategies     and depressive symptoms) and with the outcome of elective coronary angiography (CA).   "
36800|NCT02803996|"     This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and     multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that     was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of     Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been     undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a     Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.      This study will consist of two parts and the subjects will be assigned to two parts.      In each part of the study, subjects will be enrolled in the study within 28 days of     screening.   "
36804|NCT02803944|"     Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients.     It was shown that this treatment taken every day or every week for 12 months, can improve the     respiratory state of patients. From the second year of treatment, it would appear there is     more profit to continue such treatment.      The main objective is to study the association between continuous use of azithromycin and     lung function measured by Forced expiratory volume in one second (FEV1), after two years of     treatment.   "
36805|NCT02803931|"     This study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify the     site of the culprit vessel in patients with NSTEMI in comparison to 12-lead ECG.      NSTEMI constitutes a clinical syndrome subset of acute coronary syndrome which is most     usually caused by atherosclerotic coronary artery disease. It is defined by     electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or     positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and     in an appropriate clinical setting (chest discomfort or angina equivalent). The standard 12     lead ECG is not commonly sensitive at localising the site of the culprit lesion and even     coronary angiography may not always be helpful as the majority of lesions will not have     angiographically evident thrombus. Patients with an ACS may have multivessel disease and it     is often not possible to identify the precise site of the culprit lesion. In patients with     multivessel disease, interventionists will frequently target the most severe stenosis even     though this is not necessarily the acute lesion.      CGM (Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany) is a     form of 3D vector electrocardiography which can provide quantitative analysis of myocardial     depolarisation and repolarisation. It has CE mark and has been shown to be more sensitive and     specific than standard 12-lead ECG at diagnosing stable coronary artery disease. Furthermore,     recent work has shown CGM to be more sensitive at detecting patients with NSTEMI than     conventional 12-lead ECG      In summary, there is evidence that CGM is more efficacious than 12-lead ECG at the diagnosis     of both stable CAD and ACS. The hope is this that the clinical application can be extended to     localising ischaemia in the culprit vessel and be a valuable diagnostic aid.      The primary objective of this study is to investigate the efficacy of CGM to identify the     culprit vessel in patients presenting with NSTEMI. Secondary endpoint will be to evaluate the     efficacy of CGM to detect a significant coronary stenosis (defined as ≥70%) as compared to a     standard 12-lead ECG   "
36852|NCT02803320|"     The objective of this study was to assess the safety and appropriateness of a sunscreen     product for use on sport users, under supervised outdoor use conditions.   "
36853|NCT02803307|"     This trial is a multi-site, randomized, open-label, parallel, and single-dose administration     study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the     knee.   "
36854|NCT02803294|"     The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic     valve replacement in Chinese population.   "
36807|NCT02803905|"     The study is a phase 2, monocentric, open-label study. The investigators will recruit 12     patients with T1D to be randomly (1:1) assigned to receive islet either into the liver     through the portal venous circulation (standard procedure; arm A, n=6) or directly into the     omentum (arm B, n=6). Patients will be selected from those eligible for islet Tx based on     local practice and guidelines. Immunosuppression will consist of five doses IV infusion of     rabbit Anti-thymocyte Globulin (ATG, Thymoglobulin®), starting two days prior to the islet     transplant. Maintenance mycophenolate mofetil (MMF) therapy (1-2 g/day as BID dosing) will be     started on Day -1 pre-transplant. Tacrolimus will be administered orally twice daily on Day 1     post-transplant to maintain a trough level of 10-12 ng/mL for 3 months, then 6-10 ng/mL     thereafter. Etanercept will be given IV before the islet transplant (50 mg), and then at 25     mg (subcutaneously) on POD +3, +7 and +10.   "
36808|NCT02803892|"     This study is a phase 2, single-center, prospective, randomized, double-blind,     placebo-controlled, 3-arm parallel group (1:1:1) intervention trial to determine the efficacy     of 4 weeks rapamycin treatment and 4 weeks rapamycin treatment plus 3 months vildagliptin     treatment versus placebo in increasing endogenous insulin production and correcting glycemic     lability. It will involve 60 patients with long standing type 1 diabetes (T1D). Patients will     receive for one month placebo (Group 1), rapamycin plus placebo (Group 2), or rapamycin plus     Vildagliptin (Group 3). Rapamycin will be administered at an initial dose 0.2 mg/kg orally on     day 0 followed by 0.1 mg/kg/die (target trough levels: 8-10 ng/ml). Vildagliptin will be     administered at a dose of 50 mg x2/die starting from day 0. After 4 weeks of treatment     (period A), patients will discontinue rapamycin or relevant placebo treatment, but continue     Vildagliptin or placebo for a further 8 weeks and be monitored over this period (period B).   "
36809|NCT02803879|"     Some patients with heart failure require treatment called cardiac-resynchronisation therapy     (CRT) which involves putting a pacemaker into your heart to make both ventricles (the lower     chambers of your heart) contract together, making the pumping of the blood to the rest of     your body more efficient.      it is important to get the CRT pacemaker checked to make sure that it is working correctly     and performing its job. However it can be difficult to adjust the settings of the pacemaker     just the right amount to ensure the heart is pumping efficiently.      One of the ways this can be done is by using a special machine which uses ultrasound to make     a 2-dimensional image of the heart called echocardiogram. This technique can also be used to     measure the flow of blood in your heart and calculate how efficient it is at pumping blood.     However adjusting the settings of the pacemaker with this device is difficult to use and time     consuming.      Electrocardiogram (ECG) a 2-dimensional electrical tracing of the hearts activity is another     tool used to help adjust the settings of pacemakers, to make the heart pump more efficiently.     Furthermore, recent research has shown that this is better than echocardiogram at optimising     pacemaker device settings.      A new type of ECG called cardiogoniometry (CGM) has recently been developed which creates a     3-dimensional view of the hearts electrical activity and has already been shown to be better     than normal ECG at diagnosing certain conditions like angina and heart attacks. However it     has never been used to try optimise the settings of the pacemakers used in CRT and we hope it     will be a quicker and easier to use than then other methods available. More importantly we     hope by doing this it will reduce the symptoms that patients suffer as it is making the heart     pump more efficiently.      As it has been untested and never used in this setting before, we need to know first if the     CGM machine will recognise when the settings on the pacemaker are changed.      The aims of this study is to see if the CGM machine can pick up changes to pacemaker     settings, with the hope of running a later study to see if it can be used to optimise     settings on the pacemaker used in CRT.   "
36810|NCT02803866|"     In a hospital environment, initial parenting of a family with a preterm neonate will be very     different than expected. This unusual and stressful situation may determine the     self-confidence perceived by mothers and fathers in caring their baby and therefore could     shape future interaction with him/her as well as neurodevelopmental and behavioral     development of preterm infants.      24/7 neonatal units allow parents stay with their baby whenever they want but this free     access nor guarantee neither encourage parenting self-efficacy if it isn`t hand in hand with     a specific training program for parents.   "
36811|NCT02803853|"     The overall objective of the study is to reduce adult obesity in participating American     Indian (AI) communities and to improve understanding of the behavioral and environmental     factors affecting obesity in these settings.   "
36812|NCT02803840|"     Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are     treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary     endpoint of the study is the response rate and Quality of Life of the patients (QoL).   "
45067|NCT02695771|"     To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single     intraoperative instillation in preventing recurrence of bladder cancer.   "
36813|NCT02803827|"     Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have     viral gastroenteritis and so not treated with antibiotics - but they may indeed have a     treatable cause for their illness. The investigators will conduct a randomized trial to see     if rapid testing using novel methods to identify potentially treatable causes of diarrhoea     leads to improved outcomes. The investigators will also be randomizing children to     Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of     care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a     large multi-centre trial following the previous pilot trial.   "
36814|NCT02803814|"     Background: Recently it has been observed in pancreatic cancer that after apparently complete     surgical resection, histological examination of the surgical specimen according to a standard     protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To     increase the resection margin and reduce such high infiltration rate, a new surgical approach     based on the initial dissection of the superior mesenteric artery has been advocated.      Aims: To compare the rate of free resection margin (R0) and oncological results of two     possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the     pancreas and peripancreatic area: the classic approach versus the initial approach of the     superior mesenteric artery.      Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and     periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach     from the superior mesenteric vein will be performed and in the other group an initially     dissecting the superior mesenteric artery approach will be carried out. 116 patients are     required and the main variables considered are: free margin rates (R0) or infiltrated by     tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free     interval and survival at 1, 3 and 5 years.   "
36855|NCT02803281|"     Determine the feasibility of assessment of measures of frailty and determine if these     measures provide a clinically important contribution of risk assessment in a population of     patients undergoing major thoracic surgery for lung or esophageal cancer.   "
36856|NCT02803268|"     A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of     MT-8554 in Female Subjects Experiencing Vasomotor Symptoms   "
36815|NCT02803801|"     This pilot project is a cooperative effort between the Leisure in Fun Environments (LIFE)     Program and the Specialized Communication Resources for Children (SCRC) Program at the     Rehabilitation Centre for Children (RCC). The investigators will blend and enhance two     pre-existing programs in order to provide a new, specialized program for parents of children     with ASD or developmental delay. The two programs that will be blended together are     Promoting Flexible Thinking and Interaction with Your Child at Home and Saturday Cooking     Club. This new program will be a series of ten workshops that alternates between parents     only learning sessions and practical cooking club sessions that allow parents to focus on     practicing what they are learning with their child. These programs are based on the     principles of Relationship Development Intervention (RDI®), which focuses on providing     opportunities to establish a guided participation relationship, which will lead to     development of dynamic intelligence and important social thinking abilities. The program is     individualized to each child and builds on the principles of typical development to assist     the child in achieving social competence. Using this program, children are expected to     develop sociability in a naturally progressing order of complexity.   "
36816|NCT02803788|"     -  To study the efficacy and side effects of ondansetron with dexamethasone in patients          undergoing standard laparoscopic cholecystectomy (control group).        -  To study the efficacy and side effects of ramosetron in patients undergoing standard          laparoscopic cholecystectomy (study group).        -  To compare the efficacy and side effects of ondansetron with dexamethasone and          ramosetron in patients undergoing standard laparoscopic cholecystectomy   "
36817|NCT02803775|"     Cardiac resynchronization therapy (CRT) is a well established clinical therapy for patients     with symptomatic left ventricular systolic dysfunction and electrocardiographic QRS duration     of 120 ms or greater. Multicenter trials have consistently demonstrated CRT non responder     rates of 32-43% at 6 months. Subsequent studies have shown that utilizing     echocardiographic-guided device reprogramming for optimal atrio-ventricular (A-V) and     interventricular (VV) delays at rest have improved clinical response. Recently, an     echocardiographically validated automated pacemaker programmer-based intra-cardiac     electrogram (IEGM) algorithm has been developed for rapid optimization of sino-ventricular     (P-V), A-V and V-V delays at resting heart rates that is partially based on the     interventricular conduction time delays. Nevertheless, controversy still persists as to the     applicability of both echocardiographic and IEGM derived algorithms at elevated heart rates,     as with physical activity, when patients are more likely to experience symptoms related to     poor cardiac output.      Recent studies have shown clinical benefits of pacing from sites of late intrinsic activation     or intra-ventricular conduction delays (IVCD). Some studies have utilized the intrinsic     SENSED IVCD method while others used the right ventricle (RV)-PACED IVCD. There have not been     any studies to date that compare both methods to determine if one may yield a better clinical     outcome with lower non-responder rates.      This study predicts that the RV paced IVCD method will provide better clinical outcomes than     the longest RV sensed IVCD as determined by the clinical composite score.      The study is a prospective double blind study with an additional cross-over group consisting     only of non-responders to compare the clinical response in 72 patients receiving CRT therapy.     After successful CRT-D implantation and before hospital discharge patients will be randomly     assigned in a 1:1 fashion to Group 1 (SENSED) or Group 2 (PACED). The patient will complete a     Minnesota Living with Heart Failure questionnaire, compare echocardiographic data and be     assessed by a blinded nurse and physician prior to discharge and at each follow up visit to     maintain the double blind design.      After 3 months of follow-up, non-responders from each group will be crossed-over to the other     group and followed for an additional 3 months. Clinical data will be collected at the end of     that 3 months and compared looking at changes in symptoms, ejection fraction (EF) and other     echocardiographic measurements, New York Heart Assocation Function Class ( NYHA) class,     clinical composite scores (CCC), device interrogation data and hospital admissions between     the two groups to see if there is a statistical difference.   "
36818|NCT02803762|"     This study is an open-label, absorption, metabolism, excretion, and mass balance study of 400     mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to     6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1.   "
36819|NCT02803749|"     Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet     it frequently remains untreated and there have been no clinical trials dedicated to     evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is     effective for the treatment of generalized anxiety disorder in the general and elderly     population. It is not known if it is effective for the treatment of anxiety in Parkinson's     disease. This is a single-center, placebo-controlled, double-blind design with participants     randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg     twice daily) or placebo for 12 weeks.   "
36820|NCT02803736|"     This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture     on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in     two groups: the real acupuncture group and the sham acupuncture group.   "
37177|NCT02799056|"     The primary objective is to assess whether the fraction of diaphragmatic shortening in     combination with the presence / absence of alveolar-interstitial syndrome evaluated through     chest ultrasound may predict successful extubation in adult patients hospitalized in the     intensive care unit.   "
36821|NCT02803723|"     Holding-cuddling plus oral sucrose versus oral sucrose for reducing venipuncture pain in     newborns and infants.      Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care     units.      Such procedure is painful and several units administer 24% oral sucrose with pacifier during     venipuncture, as this non-pharmacological intervention is considered safe and effective for     procedural pain relief in infants from birth to 3 months of age. However, several studies     point out that further research is needed to assess its efficacy in combination with other     behavioral interventions for analgesia during painful procedures. Current knowledge suggests     that multisensorial stimulation associated with oral sucrose could allow even more effective     analgesia. To date, the studied stimulation strategies are based on massage, voice, eye     contact and fragrance during heel prick. The holding-cuddling - that is the fact of holding     the child in a safe, reassuring and warm position during the examination or medical     intervention is promoted by various hospitals in order to favor the comfort of all the     caregivers during such a procedures. This intervention should be primarily parents-driven     but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of     this study is that the combination of holding-cuddling plus oral sucrose in more effective     than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns     or infants less than three-month-old.   "
36822|NCT02803710|"     Upon penicillins' introduction, inactivation of beta- lactam antibiotics by enzymes produced     by bacteria was demonstrated. Until recently, carbapenems were a relatively spared subclass     by these enzymes which makes the molecules of last resort in serious infection. Recently the     prevalence of enzymes hydrolysing carbapenem, the carbapenemases, was increasing in some     countries. But these carbapenemases are not the only mechanism involved in a decreased     susceptibility to carbapenems which is sometimes linked to the conjunction of several     resistance mechanisms. Data available on the epidemic situation of this new resistance are     essential for improving their detection, the management of infections in patients and prevent     the occurrence of epidemic. In this context, the investigators propose a study in the     North-East inter-region to estimate the prevalence of Enterobacteriaceae with decrease     susceptibility to carbapenems and look for risk factors for infection with this type of     bacteria. The study is conducted in five teaching hospitals (Besançon, Dijon, Nancy, Reims     and Strasbourg) and two general hospitals (Colmar and Troyes) in North-Eastern France. For     one year, all the Enterobacteriaceae isolates with a decreased susceptibility to carbapenems     (CDSE) according to the 2012 Antibiogram Comity of the French Microbiology Society (CA-SFM)     (MIC of ertapenem > 0.5 μg/mL) are collected and sent to the bacteriology laboratory of the     Reims University Hospital. Among these strains 105 are randomly selected. The clinical study     is conducted as follow: for each patient with CDSE isolate included in a center, 2 control     patients are selected. They are the patients having the 2 Enterobacteriaceae isolates, with     no reduced susceptibility to carbapenems and following the CDSE isolate in the same center.      Microbiological study : identification of isolates is performed using MALDI-TOF (Bruker     Daltonics, Bremen, Germany). Antibiotic susceptibilities is determined by the disc diffusion     method according to European Committee on Antimicrobial Susceptibility Testing (EUCAST)     guidelines (www.EUCAST.org) and extended-spectrum beta-lactamase (ESBLs) are detected by the     double-disc synergy test and carbapenem minimal inhibitory concentrations (MICs to Imipenem,     Ertapenem, Doripenem and Meropenem) determined using E-test® strips. Metallo-β-lactamase     production was screened with the MβL Etest (bioMérieux, Marcy l'Etoile, France).     Beta-lactamases detected using polymerase chain reaction (PCR). Carbapenemase-encoding genes     (blaKPC, blaVIM, blaIMP, blaNDM, blaOXA-23-like, blaOXA-24-like, blaOXA-58-like and     blaOXA-48-like) were screened using multiplex PCRs and blaIMI and blaGES with simplex PCRs.     All the blaOXA-48-like detected were subsequently sequenced. Genes blaTEM, blaSHV, blaCTX-M     and blaOXA were detected by PCR using specific primers. Plasmid-mediated AmpC-type genes     blaACC, blaFOX, blaMOX, blaDHA, blaCMY and blaMIR were screened using multiplex PCRs. All the     beta-lactamases are sequenced. Mutations in the quinolone resistance determining region     (QRDR) are identified by PCR and sequencing in the gyrA, gyrB, parC and parE genes. Qnr and     qepA genes are detected by real-time PCR, aac(6')-Ib-cr by pyrosequencing and oqxAB by     conventional PCR. Genotyping is performed with pulsed-field gel electrophoresis (PFGE) and     multilocus sequence typing (MLST).      Statistical analysis : qualitative variables are analysed with the Chi2 test and the     two-tailed Fisher exact test. Quantitative variables are compared using the Mann-Whitney     test. Then, a multivariate analysis is conducted: logistic regression with stepwise factors     as explanatory variables with p <0.20 in the univariate analysis as input threshold and     output set at 0.20.The results are considered statistically significant when P < 0.05.      Expected results : this study will give the proportion of the different species involved, of     the carbapenemase in comparison to the other mechanisms, the level of resistance in MIC. Risk     factors such as previous antibiotic treatment, underlying disease severity or clonal strain     transmission will be evidenced, allowing to identify prevention control measure to implement.   "
36857|NCT02803255|"     The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that     follows the assist-as needed paradigm provide statistically significant improvements in arm     and hand motor functions when compared to robot-aided protocols that passively move patients'     arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).   "
36824|NCT02803684|"     While renal graft outcomes were really improved for the last decade, long time outcomes     remains stable. Indeed, at 10 years after transplantation, the renal graft survival rate     reaches 50%. The chronic allograft nephropathy is the main cause of renal graft loss. Other     features such as acute allograft rejection, delayed renal recovery and anti-human leukocyte     antigen (anti-HLA) antibodies are associated with poor renal graft survival prognosis. Renal     graft protocol biopsies at 3 and 12 months after transplantation are valuable to detect     precociously renal injuries at a reversible stage before clinical manifestation. However,     renal biopsy is an invasive examination with hemorrhagic risk. Diffusion MRI could be a     non-invasive diagnostic tool allowing the early detection of renal injuries, especially     allograft rejection without hemorrhagic risk. This tool could be applied routinely to the     renal allograft recipient in replacement of protocol biopsies.      Here, aim of this study is to correlate the results from diffusion MRI of renal graft with     pathologic findings from protocol renal graft biopsies.      In this view, the investigators include prospectively all recipients of renal transplantation     who beneficiate of a protocol renal graft biopsy without barrier to peform MRI examination.     Thus, the investigators exclude patients who are not be able to beneficiate of a MRI     examination and patient obstacle to renal graft biopsy.      Expected results are the Banff classification from the histopathologic analysis of biopsies.     The expected results for MRI examination are signal intensity, diffusive coefficient,     anisotropy fraction and change of the diffusion way. Next, the investigators search an     association between these features by statistical analysis (Wilcoxon test, Chi², Fisher,     Pearson or Spearman).      The investigators performed this study since 01/06/2014 and projected end-time to 01/06/2017.   "
36825|NCT02803671|"     This project corresponds to the main field of research of the investigators's laboratory     concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In     this context, the investigators have developed know-how and specific acquisition and analysis     tools (2 patents and several publications), allowing them to apply this know-how in children     with patent ductus arteriosus.      Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of     cardiac output towards the pulmonary circulation. The direct consequences of this shunting     are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk     of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such     as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other     systemic organs are deprived of part of their normal perfusion and are subject to ischaemic     hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical     dysfunction, the analysis of which constitutes one of the objectives of this project.   "
36826|NCT02803658|"     About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of     cases, a male component is identified, but is not always sufficient to explain infertility.     In the majority of cases, the cause cannot be clearly identified and multiple abnormalities     may be detected in both partners.      Many factors concerning lifestyle and environment (medications, alcohol, smoking, pollution,     exposure to heat, toxins, xenobiotic oestrogens, etc.) may impact on fertility. These factors     may also impact on the fertility of the children conceived, which is described as an     intergenerational effect (alteration of the fertility of boys exposed to smoking in utero).      Few scientific studies with a high level of proof have been published on the impact of     smoking on the couple's fertility. Gonadal functioning and the quality of gametes can be     altered by these environmental factors, which may trigger a process of apoptosis or     alteration of the DNA of gametes (sperm DNA fragmentation). Other modifications include DNA     methylation and histone acetylation, which control gene expression and are grouped under the     term epigenetic modifications. More recently, oestrogens has been shown to be involved in     male reproductive function by acting on spermatogenesis, spermiogenesis and epididymal     maturation. Demonstration of an active aromatase (Arom) (mRNA, protein and activity) in     ejaculated human spermatozoa suggests the synthesis of small quantities of oestrogens in     spermatozoa. The study of transcript profiles could provide information about the quality of     spermatogenesis and/or spermiogenesis and during the first steps of embryonic development.     Confocal microscopy has colocalized the aromatase on the head, midpiece and tail and can be     used to assess the quality of the acrosome with anti-CD-46 monoclonal antibody. Even low     concentrations of xenobiotic oestrogens can exert biological effects on certain functions of     murine or human spermatozoa, accelerating capacitation and the acrosome reaction. These     factors are all the more effective when they act in combination, as human gametes appear to     be more sensitive to their action than murine gametes All studies conducted to date have     investigated the impact of toxins either on one of the partners or in the children born to     the couple. No detailed and high-level scientific study has studied both partners and the     quality of their embryos.   "
36882|NCT02802930|"     The primary objective of this study was to evaluate the potential for phototoxicity of the     sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a     negative control (0.9% sodium chloride [NaCl]) after a single 24 h application of test     materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).      The secondary objective of this study was to evaluate the safety of the sun care products SPF     50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring     adverse events (AEs) throughout the study.   "
36883|NCT02802917|"     The primary objective of this study was to compare the human eye stinging potential of     experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50     X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.   "
45068|NCT02695758|"     A non-blinded randomized controlled trial, in which participants undergoing primary reverse     or total shoulder arthroplasty are randomly assigned to one of two treatment groups.   "
36827|NCT02803645|"     Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies,     predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA).     Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous     and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary to     an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in the     context of APS, APL can also be observed in various clinical situations and in healthy     subjects. Published studies have reported a variable prevalence of APL in healthy subjects,     essentially ACL and/or LA, and their clinical significance currently remains unclear.      Several studies have highlighted the link between APL and atherosclerosis. It therefore     appears interesting to more specifically study the association between the presence of APL     and the presence of cardiovascular risk factors in a population of healthy subjects.     Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a     complex interaction between atherogenic plasma factors and cells of the arterial wall.     Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid     peroxidation also plays a major role during the atherogenesis process. It will therefore also     be important to correlate APL with markers of vascular inflammation and markers of oxidative     stress.      A prospective case-control study will therefore be conducted on 1,500 healthy blood donors.     Subjects screened APL-positive will be compared to APL-negative subjects in terms of     cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular     disease will not be studied). In the context of a blood donation, all subjects wishing to     participate in this study will attend a medical interview and a clinical examination during     which various data will be collected, mainly the presence of cardiovascular risk factors. A     blood sample will also be taken to assay the various laboratory markers studied.      This study should provide a better understanding of the role of APL in healthy subjects and     more clearly specify their possible link with atherosclerosis in this population.   "
36828|NCT02803632|"     An excess suicide-related morbidity is observed among young people in the Picardie region, as     reflected by the > 100% occupation rate of the Amiens University Hospital Adolescent Medicine     Unit. New approaches have been proposed to these problems that have led us to reorganize our     diagnostic practices: 1) more precise characterization of suicidal behaviour by using     standardized instruments such as the French version of the Columbia-Suicide Severity Rating     Scale developed by Posner (C-SSRS); 2) new clinical entities, such as disruptive mood     dysregulation disorder, are now proposed in international classifications (DSM 5 field     trial); 3) investigations such as recording of the circadian rhythm of motor activity by     actigraphy are being studied as a laboratory complement to psychiatric diagnosis.   "
36829|NCT02803619|"     Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced     Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT)     chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced     NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal     growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in     selected NSCLC patients in some retrospective research. Our single-center prospective     research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM     patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A     multi-center prospective observational biomarker study will be started in 11 lung cancer     center based on our single-center prospective research result. The aims of the study are to     find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based     comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical     assessment criteria for NSCLC-LM EGFR-TKIs treatment.   "
36830|NCT02803606|"     Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal     Medicine unit will be included after informing the parents. Abdominal skin and peripheral     (arm or leg) and incubator air temperatures and relative humidity will be obtained from data     recorded by the incubator without using any additional transducer compared to standard care.     Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization     will also be recorded from routine monitoring. A case report form and a wide-angle video     recording of the infant's room will allow description of the type of care, determine the     duration of care and the impact on incubator function. Data will be recorded for the first 7     days of life of the preterm neonate.   "
36831|NCT02803593|"     The purpose of the proposed randomized intervention study is to test the efficacy of the     technology-based information and coaching/support program for Asian American breast cancer     survivors (TICAA) in enhancing the women's breast cancer survivorship experience at three     time points (pre-test, post1-month, and post 3-month).   "
36832|NCT02803580|"     The purpose of the present study is to evaluate the characteristics, management and clinical     course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in     terms of symptoms, lung function and exercise tolerance during 12 months of observation.   "
36833|NCT02803567|"     The primary goal of this project is to develop a tailored screening, brief intervention and     referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for     delivery at point of care during a routine healthcare visit, through conducting a rigorous     randomized control trial among adolescent patients with type 1 diabetes (TID) or     rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of     parents of these same adolescents, to explore links between parent beliefs and adolescent     behavior around substance use.   "
36834|NCT02803554|"     The purpose of the study is to evaluate the beneficial effects of infusions of plasma from     young donors using blood biomarkers.   "
36835|NCT02803541|"     Purpose: Most children and adolescents with chronic kidney disease (CKD) have much less     physical endurance than their age matched peers, are at high risk for premature     cardiovascular disease, and have a poor self image in part due to limited peer contact.     Sustained exercise in adults with CKD improves endurance and decreases cardiovascular risk.     Minimal data exists in pediatric CKD patients. This study will show whether 12 days of     increased exercise at a summer camp will improve endurance as measured by the distance walked     in 6 minutes and self concept as measured by a short standardized questionaire (Harter     scale).      The study will occur at the Frost Valley YMCA in the Catskills where in 2, 12 day sessions a     total of 25-30 kidney campers are mainstreamed in the general camp population of about 500.      Mainstreaming means that the kidney camper will live in a cabin with 8-10 age matched peers     and participate as much as possible in all camp activities with their bunkmates. The kidney     program at Frost Valley provides hemo and peritoneal dialysis, as well as caring for children     with less advanced CKD and post transplant.      Participants will have activity measured before and duringcamp by wearing a pedometer. The     distance walked in 6 minutes (a 6 minutewalk test) will be measured at onset and completion     of the 12 day camp experience. A standardized questionaire on self concept will also be     administered at the onset and completion of camp.   "
36836|NCT02803528|"     Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.   "
36837|NCT02803515|"     Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It     corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal     treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic     lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved     survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%.     The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°).     However, the cellular mechanisms involved are not fully understood, but they include cell     death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on     pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and     exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of     this study are to validate these findings in tissue samples of patients with ovarian PC. We     will constitute a bank of isolated tumor samples before and after HIPEC and measure     postoperative HSP90 serum levels in order to establish if they are predictive of a response.     HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four     patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden     therapeutic possibilities including the use of new immunotherapy. The multimodal approach     could improve the efficacy of HIPEC with a minimal systemic toxicity.   "
36858|NCT02803242|"     The COPD Patient-Powered Research Network (COPD PPRN) is a patient research registry with the     goal of enrolling 75,000 or more COPD patients and those at risk who are willing to share     their heath information over several years and participate in research. The COPD PPRN has     built an online platform to allow volunteers to enroll electronically, complete surveys, be     contacted about studies they qualify for and become connected to COPD resources. The goal of     the registry is to speed research to find better treatments for COPD and ultimately a cure.   "
41953|NCT02736487|"     The purpose of this research project is to examine whether short-term use of portable air     pollution filtration can result in changes in indoor airborne pollutants and impact on     cardiovascular and respiratory health outcomes of the inhabitants.   "
36838|NCT02803502|"     In the context of hemophilia, it is well know that the level of factor VIII alone does not     reflect the clinical phenotype of the patients in an accurate way. At equal factor VIII     levels, certain patients will bleed more than others.      The thrombin generation test (TGT) is a test that seems to provide a better prediction of the     overall hemostatic status of an individual patient. In a previous study, the investigators     have established normal reference values of the thrombin generation curve in children aged 6     months to 16 years and adults. The goal was to evaluate the use of this test in different     clinical contexts and in severe hemophilia patients in particular. A pilot study showed that     the patients having a thrombin generation <150 had a severe phenotype, whether those who     received an appropriate prophylaxy had a thrombin generation superior to 150.      Moreover, the investigators now have access to a software tool that allows them to     individually determine the pharmacokinetic profile of the factor VIII injected to each     patient. The factor VIII concentration is measured at injection and 30 minutes, 1 hour, 2     hours and 24 hours afterwards. The introduction of these concentrations in the software     allows to obtain the half-life of factor for a given patient, the maximum peak, and the     minimum factor level (though level). The injected dosis might be sufficient (disappearance of     substantial diminution of the bleedings) or unsufficient (persisting bleeding) for a given     patient.      This study aims:        -  to measure the pharmacokinetic profile of factor VIII by two different methods, the          time-based method and the chromogenic method        -  to correlate the results with the TGT results obtained at the same time points and          determine which method gives the best correlation        -  to link the clinical symptomatology (improved symptomatology or not) with the TGT          results        -  to determine which minimal TGT result is linked to a minimal bleeding rate        -  to adapt the prophylactic dosis of the patient in a personalized way.   "
36839|NCT02803489|"     Prospective, non-randomized, open-label, pilot study conducted in a single group of 30     evaluable patients, i.e. patients completing an approximate 3 month follow-up.   "
36840|NCT02803476|"     The primary aim of the current study is to clarify whether serum vitamin D levels [25(OH)D3]     have a temporal association with insulin resistance and/or insulin sensitivity in PCOS women     versus healthy ones.      To achieve this aim, the investigators will conduct a prospective observational study     involving obese and lean PCOS women in comparison to obese and lean healthy subjects living     in Cairo, Egypt.   "
36841|NCT02803463|"     There has been no consensus over closure versus non closure of peritoneum during abdominal     operations. The aim of this study is to compare the effect of peritoneal closure versus non     closure over postoperative pain, early complications and life quality.   "
36842|NCT02803450|"     This prospective, randomized, single blinded control trial will investigate the effects of     epidural loading with a high volume, low concentration local anesthetic solution via the     epidural needle versus the epidural catheter.   "
36843|NCT02803437|"     This study is a Japanese post-marketing surveillance (PMS) which is required by the     regulatory authorities. General objective of PMS is to confirm the clinical usefulness,     especially the safety profile of a drug under the routine clinical practice.   "
36844|NCT02803424|"     The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the     potential to cause an adverse effects on respiratory mechanics and gas exchange.     Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak     pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled     ventilation improves gas exchange and respiratory mechanics in patients undergoing     robot-assisted laparoscopic radical prostatectomy.   "
36845|NCT02803411|"     To describe the natural history of the coronary atherosclerotic plaque development and     progression over time by CCTA with demographic and laboratory data for refinement of risk     stratification of patients referred for CCTA.   "
36846|NCT02803398|"     The aim of the study is to measure and model interface pressure applied on the lower leg of     patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex     16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher). The patient specific model should better     predict the interface pressure distribution than Laplace's Law.   "
36847|NCT02803385|"     This study aims to compare the efficacy of pain control, the consumption of local anesthetic     and opioids, side effects, and patient satisfaction between continuous epidural infusion and     patient controlled epidural analgesia after thoraco-abdominal surgeries in cancer patients.   "
36848|NCT02803372|"     The purpose of this study is to investigate whether circulatory management based on     LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients     undergoing partial nephrectomy when compared with routine circulatory management based on     blood pressure and urine output monitoring   "
36849|NCT02803359|"     The primary purpose of this study will be to determine whether the proposed study protocol     will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR).     Laryngeal evoked brain stem responses will be recorded from five test subjects under general     anesthesia in the operating room with the assistance of an electrophysiologist with expertise     in evoked potentials. Once the feasibility of obtaining tracings are established on the first     few subjects, responses will be recorded from other test subjects with the aim of determining     the optimal placement of stimulating electrodes and detection leads necessary to elicit an     adequate response. The effect of varying the stimulus intensity will also be studied. Once     parameters for testing have been standardized, normative configurations for the laryngeal     evoked brainstem response tracings can be determined by patients both in the office setting     and in the operating room.   "
36850|NCT02803346|"     Septic syndromes (systemic inflammatory response associated with infection) remain a major     although largely under-recognized health care problem and represent the first cause of     mortality in intensive care units. While it has long been known that sepsis deeply perturbs     immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings     indicate that sepsis indeed initiates a more complex immunologic response that varies over     time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a     resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted     immunosuppression. This is illustrated in those patients by reactivation of dormant viruses     (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic     solely in immunocompromised hosts. These alterations might be directly responsible for     worsening outcome in patients who survived initial resuscitation as nearly all immune     functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed     markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and     deactivated monocyte functions). New promising therapeutic avenues are currently emerging     from those recent findings such as adjunctive immunostimulation for the most immunosuppressed     patients. The prerequisite for immunostimulation administration (IFNg, GM-CSF, IL-7) however     relies on the investigators capacity in identifying the patients who could benefit from it,     as there is no clinical sign of immune dysfunctions. The main objectives are:        1. to identify the best biomarkers for sepsis-induced immunosuppression and        2. to evaluate ex vivo whether drugs could rejuvenate immune functions.   "
36859|NCT02803229|"     The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety     and benefit of Extended-release mixed amphetamine salt (Adderall-XR, MAS-XR) in the treatment     of individuals with Cannabis Use Disorder (CUD) and Attention-deficit/Hyperactivity Disorder     (ADHD). The investigators plan to enroll 50 and randomize 40 of these patients in the trial.     The primary objective of the study is to determine the efficacy of MAS-XR in promoting     cannabis abstinence among individuals with CUD and in promoting a decrease of ADHD symptoms.   "
36860|NCT02803216|"     To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) decoction and     powder combined with standard triple therapy on improving eradication rate of Helicobacter     Pylori (H. pylori).A multi-center randomized control clinical trial design was adopted in the     trial.   "
36861|NCT02803203|"     The purpose of this study is to test the safety of combining the drugs osimertinib and     bevacizumab at different dose levels. The investigators want to find out what effects, good     and/or bad, taking osimertinib and bevacizumab has on the patient and lung cancer. This study     will try to find the best dose of osimertinib and bevacizumab given together that does not     cause significant side effects. Once the investigators determine that combining osimertinib     and bevacizumab is safe, they want to see if the combination is effective in treating lung     cancers with the EGFR mutation.   "
36862|NCT02803190|"     The investigators' previous studies in 2014 and 2015 have demonstrated that among     community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia     indices can be improved and bone mineral density (BMD) maintained with different exercise     programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions     on posture corrections and further improvement of sarcopenic indices   "
36863|NCT02803177|"     In the present phase-II clinical trial the researchers investigate efficacy and proof of     concept of the augmentation with preoperatively isolated autologous BMC cells seeded onto     ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of     proximal humeral fractures.   "
36864|NCT02803164|"     Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds     (OCW) and will decrease the time-to-closure of such wounds when compared to a historical     cohort of patients managed by traditional wound care management.   "
37178|NCT02799043|"     A prospective, multicenter, randomized study to assess the safety and effectiveness of     FIRM-guided procedures in conventional redo RF ablation procedures for the treatment of     persistent and paroxysmal atrial fibrillation.   "
36865|NCT02803151|"     Lymph node metastasis is one of the most common sites to develop disease recurrence or     progression after initial local treatment for primary solid malignancies or systemic     treatment for advanced metastases. No specific treatment modality has been established as the     standard therapy. Systemic therapy is usually considered since lymphadenopathy is considered     as a sign of disease dissemination though aggressive local treatment, including surgical     lymphoadenectomy or radical radiotherapy might result in long-term survival in selected     patients. The concept of stereotactic ablative radiotherapy (SABR), a high dose of radiation     targeted to a pathological entity and delivered in a few fractions, has proven so successful     at treating both benign and malignant lesions that it changed the paradigm for radiation     therapy. The radiobiology of SABR has been shown to be very favorable for tumor control.     Clinical experiences suggested that SABR might offer excellent in-field tumor control with     low toxicity profile in selected patients, although the majority of reports are retrospective     and include small patients series with heterogeneous tumor sites and dose-fractionation     schedules.      At present, there is lack of validated prognostic factors to identify the patients who might     benefit most from ablative local therapy for metastatic lymph node(s). The mechanism of     effect of SABR on the cancer lesions is not yet clear. Apart from its direct effect on     clonogenic cancer cells, an immune-mediated process was also hypothesized. Therefore, the     present study is aimed to provide a better understanding about utilization of SABR for     metastatic lymph node(s). The associated translational researches will also advance our     knowledge in the immune system reactions to SABR.   "
36866|NCT02803138|"     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)     has been shown to be safe and effective in randomized controlled clinical trials with strict     inclusion and exclusion criteria under well controlled conditions.      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±     RBV, used according to local label, under real world conditions in Israel in a clinical     practice patient population.   "
36867|NCT02803125|"     The purpose of this project is to develop an intervention to improve psychosocial functioning     and quality of life for older Veterans with partial or full PTSD.   "
36868|NCT02803112|"     The investigators aim to retrospectively map the delays in the acute care of traumatic brain     injury patients necessitating emergent craniotomies.   "
36869|NCT02803099|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
36870|NCT02803086|"     The prophylactic irradiation of pelvic lymph-nodes by means of Whole-Pelvis Radiotherapy     (WPRT) in the treatment of prostate cancer (PCa) is aimed at the timely eradication of     microscopic lymph-nodal metastases. Nevertheless, even though delivered by means of modern     Intensity-Modulated Radiotherapy (IMRT) techniques, WPRT may result in intestinal,     hematologic and urinary toxicity (IT, HT, UT, respectively) severely affecting patients'     daily health-related quality-of-life (HRQoL) within the so-called and inadequately     investigated Pelvic Radiation Disease.      The aim of this study is to develop sophisticated predictive models of IMRT-WPRT induced     patient-reported HT, IT and UT in PCa. The possible correlation between several clinical     factors and radiation doses received by various pelvic structures (i.e. pelvic bones     subvolumes, intestinal loops, sigmoid, rectum and bladder) and risk and severity of     patient-reported IT, UT and HT will be analyzed and robust multi-variable models will be     developed and internally validated. A secondary end-point will be the identification of     specific symptoms affecting patients' HRQoL during irradiation and in the long term, overall     and in different therapeutic settings (radical, adjuvant and salvage). Lastly, possible     correlation between HT and UT/IT will be investigated.   "
36871|NCT02803073|"     The purpose of this study is to determine the effects of testosterone replacement in     hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial     infarction.   "
36878|NCT02802982|"     Parents of infants who have been thrombocytopenic for 3-4 days will be approached for consent     to enter the study. For the purposes of the study, thrombocytopenia will be defined as a     platelet count <60,000/uL or a platelet count <100,000/uL that prompted a platelet     transfusion. Following enrollment, the platelet count will be followed in each infant.     Participants will enter the study if on day 5 or later after the onset of thrombocytopenia     (defined as above) infants either have a platelet count <60,000/uL or a platelet count     <100,000/uL for which a platelet transfusion is ordered.   "
36879|NCT02802969|"     Improved local control of chordoma initially treated with surgery or not, thanks to adjuvant     radiotherapy oriented by conventional imaging Computed Tomography /Magnetic Resonance Imaging     (CT / MRI) and guided by the [18Fluor] ([18F]) Fluoroazomycin Arabinofuranoside (FAZA)     Positron Emission Tomography / Computed Tomography (PET / CT) to target the radioresistant     hypoxic cells.   "
36880|NCT02802956|"     Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke   "
36881|NCT02802943|"     The aim of this study is to induce a peptide-specific immune response in chronic lymphatic     leukaemia (CLL) patients by multi-peptide vaccination with a patient-individualized peptide     cocktail and, dependent on minimal residual disease (MRD) status, the immunomodulatory drug     lenalidomide.   "
36947|NCT02802085|"     Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance     plan for the product under investigation.      For this PMCF only CE-marked medical devices have been used and will be used within their     intended purpose and no additional invasive or other stressful examinations have been or are     to be carried out (acc. to MPG §23b).   "
36884|NCT02802904|"     Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol     backbone to which 3 esterified fatty acids are attached. The positions of fatty acid     attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing     evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with     predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of     fat molecules do not raise serum cholesterol levels. These observations have come to be known     as or explained by the sn-2 hypothesis. New evidence have also emerged to show that     saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a     rat model. In this proposed study, the effects on the outcome measures investigated of three     test fats [namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)], with     oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and     oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated   "
36885|NCT02802891|"     The JOIN project combines the health and indoor environment research areas to contribute in     the development and validation of a new asthma diagnosis method through exhaled VOC analysis.     This method is more sensitive, more specific, and completely non-invasive. Moreover, the JOIN     project will assess the impact of exposure to the indoor environment, namely endocrine     disruptors, on asthma and allergy development in children.   "
36886|NCT02802878|"     The purpose of this study is to assess the efficacy of a 12-week low-load neuromuscular     electrical stimulation with volitional contraction (NMES-VC) training program to improve     quadriceps strength and activation, while not adversely affecting knee-related pain,     activities of daily living or quality of life in women with knee pain. The primary outcome     will be change in maximal isokinetic knee extensor torque.      The investigators will test the following hypotheses. In comparison with low-load (40%)     resistance training without electrical stimulation, a 12-week NMES-VC training program will:      Hypothesis 1: Increase maximal isokinetic knee extensor torque      Hypothesis 2: Increase rate of muscle force development      Secondary questions and response variables      Hypothesis 3: Not adversely affect knee pain or quality of life, assessed by the Knee injury     and Osteoarthritis Outcome Score (KOOS) questionnaire      Additional hypotheses in women with risk factors for incident symptomatic or progressive KOA:        1. Determine the extent to which NMES-VC-enhanced low-intensity resistance training          increases quadriceps muscle rate of force development        2. Determine the extent to which NMES-VC enhanced low-intensity exercise is tolerated          (using numeric rating scale survey level of pain you experienced during the hybrid          training or 40% isokinetic exercise)        3. Determine the extent to which NMES-VC-enhanced low-intensity resistance training          increases physical function (20m walk, chair stand, stair climb times, KOOS)        4. Determine the extent to which NMES-VC enhanced low-intensity resistance training          increases pressure pain threshold   "
36887|NCT02802865|"     This study evaluates the addition of clomid to letrozole for the treatment of infertility in     women with polycystic ovary syndrome. Half of the participants will receive letrozole and     clomid in combination, while the other half will receive letrozole alone.   "
36888|NCT02802852|"     Neovascularization (NV) is the innate capability to enlarge collateral arteries     (arteriogenesis), and to stimulate growth of new capillaries, arterioles and venules at the     tissue level (angiogenesis). Patients with Chronic Limb-threatening Ischemia (CLI) present     with forefoot rest-pain, ulceration and/or gangrene. They require risky and costly     revascularization operations to avoid amputation. The investigators hypothesize that their     inadequate NV can be modulated to restore this capability. By correcting impediments to NV in     an out-patient setting, the investigators expect to facilitate CLI management.      While the following impediments to NV are complex, the solution is not. Arteriogenesis     necessitates endothelial cell activation in small collaterals as blood is offloaded away from     the occluded artery. Shear stress provides this stimulus, but is attenuated caudal to     multi-level arterial occlusive disease. The arteriogenesis switch is not turned on.     Furthermore, the lack of nutritive oxygenated blood inflow and the accumulation of toxic     metabolic by-products are adverse to synthetic pathways in the ischemic tissue. Additionally,     protein distress signals cannot be effectively disseminated by the ischemic tissue, and the     reparative progenitor cells they are supposed to mobilize cannot effectively home back to the     ischemic tissue to orchestrate NV. The CLI patient is especially disadvantaged by having     diminished function and number of circulating progenitor cells (CPC). Lastly these elderly,     often diabetic, patients are less able to fend off infection.      An FDA approved external programmed pneumatic compression device (PPCD) was used to restore     the shear stress stimulus required for arteriogenesis. It also enhances oxygenated nutritive     arterial inflow, clears waste products of metabolism (increased venous and lymphatic     outflow), and helps distress proteins reach the central circulation and mobilized progenitor     cells to return to the ischemic tissue. We corrected the progenitor cell and immunologic     impairment with granulocyte colony stimulating factor (G-CSF), FDA approved for stem cell     mobilization and immunological boost in the setting of cancer chemotherapy. The preliminary     data show clinical, angiographic, hemodynamic and biochemical evidence for enhanced NV. The     purpose for this study is to enroll 25 patients to reproduce the biochemical data to support     a large scale clinical trial.   "
41954|NCT02736474|"     The purpose of this research is to observe the efficacy of Naltrexone and Bupropion     combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.   "
36889|NCT02802839|"     Children with Cystic fibrosis (CF) have to undergo several needle-related procedures during     outpatient visits or hospital stay. It is common for children with CF to display distress and     behavioural problems during invasive procedures. Children with chronic diseases have a lower     threshold of pain compared to non-chronic patients. Effective management of needle distress     in children with CF is critical. Although pharmacological and non pharmacological methods are     used during needle -related procedures to lower painful stimuli nearly all patients with CF     experience anxiety. Distraction has been shown to be an effective technique that directs     children's attention away from noxious stimuli. The application of Virtual Reality (VR) in     the medical field has been shown to be successful already 15 years ago. VR has found its use     during the medication of burns and in patients undergoing cancer treatments whereas so far     few studies have been published to assess its efficacy in reducing needle related pain and     distress in children and none in children with CF.      Objectives To assess the efficacy of VR in reducing pain and distress during venipuncture in     children with CF compared to routine care.      Project description Randomized controlled parallel trial with a 1 to 1 allocation ratio. The     use of VR compared to standard care during venipuncture in children with CF (age 6-18 years)     attending the outpatient clinic of the CF Centre of Florence will be compared over the period     of 1 year. Patients randomly assigned to arm A will use VR during the procedure, those     patients assigned to arm B will receive routine care.      Anticipated output Determination of the efficacy of VR in lowering pain and distress during     venipuncture.   "
36948|NCT02802072|"     To investigate the long-term effects of intracranial implantation of Enterprise stent system     versus antiplatelet medication on neurologic deficits, daily living abilities, and carotid     artery stenosis in patients with atherosclerotic ischemic stroke.   "
36890|NCT02802826|"     Chemotherapy forms a significant part of many breast cancer patient's treatment and is     associated with various common, known adverse effects. For the last few decades, physical     activity has been emerging as a viable intervention to help many of these adverse effects.     The study will determine if the provision of a 12-week tailored walking programme, provided     alongside a home-based exercise prescription from a cancer doctor results in improved levels     of physical activity and quality of life in patients with breast cancer undergoing     chemotherapy.   "
36891|NCT02802813|"     This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can     eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).   "
36892|NCT02802800|"     Field hockey players, recruited from clubs in Jamaica, will be randomized to either a water     training or land training groups. Persons will be exposed to 6 weeks of plyometric training     with two sessions per week. Pre and post test measures will be done for lower limb power,     flexibility and agility. Distance covered, pace, heart rates and exertion during a match will     also be assessed.   "
36893|NCT02802787|"     Implementation and Evaluation of an Activity Based Program to Improve Quality of Life, Pain     and Fatigue Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction,     decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods     Quality of Life, Pain and Fatigue surveys).   "
36894|NCT02802774|"     The management of distal radius fractures has been in a state of evolution over the past 30     years. Treatment has become increasingly focused on obtaining a stable, internal construct     for quick return to normal, daily activities. With the advent of volar locking plates, the     wrist fracture is stable before the patient leaves the operating room. As surgical plate and     screw constructs become more stable, the need for casting and splinting may be less.      The presumptive next step in operative management of distal radius fractures is to do away     with the postoperative splint. A review of the available English language literature failed     to reveal any studies evaluating the use of postoperative splinting and patient outcomes.      This prospective, randomized study was designed to investigate the use of temporary plaster     splints versus removable over-the-counter splits versus soft dressings for post-operative     treatment of extra-articular and intra-articular distal radius fractures. The patients will     be followed for 12 months evaluating maintenance of fracture reduction and patient outcomes.   "
36895|NCT02802761|"     Study Cohort:      All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with     Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient     Department   "
36896|NCT02802748|"     VENTANA is a window-of-opportunity trial that will explore whether, similar to CDK4/6     inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior     anti-proliferative effect than Letrozole alone.   "
36897|NCT02802735|"     This two-part study has been designed to evaluate the Pharmacokinetics (PK) of single and     multiple doses of apremilast in healthy adult male Korean subjects.   "
36898|NCT02802722|"     Previous research has shown that people who have been hospitalised for pneumonia are more     likely to die of conditions such as heart attacks, stroke and cancer in the weeks to months     after their illness. This risk is linked to raised levels of inflammation. Laboratory     research shows that vitamin D can help to clear inflammation. Vitamin D deficiency is very     common in the United Kingdom. The investigators are conducting this study to find out if     taking vitamin D can hasten long-term recovery from pneumonia by reducing inflammation.   "
36899|NCT02802709|"     This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.     Half of the patients will receive the agent via intra-articular injection and half will     receive a placebo injection.   "
36900|NCT02802696|"     This is a pilot double-blinded placebo-controlled randomized controlled trial (RCT) to     evaluate the feasibility of conducting a multicenter, randomized, placebo-controlled trial to     assess the efficacy of pre-transfusion furosemide in preventing transfusion-associated     circulatory overload (TACO) in hemodynamically stable inpatients aged 65 years or older     receiving a single unit red blood cell transfusion. Patients will be randomly allocated to     receive either furosemide (20mg intravenous) or placebo (saline) within 60 minutes of     starting a red blood cell (RBC) transfusion. Randomization will be stratified by centre and     renal dysfunction (creatinine clearance ≥ 60 mL/min or < 60 mL/min). This is a blinded trial:     patients, care-providers (physicians and nurses), data collectors, outcome adjudicators, and     data analysts will not be aware of group allocation.   "
36902|NCT02802670|"     This is an open-label, non-randomized study to determine the excretion kinetics and mass     balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in     healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing     approximately 100 microcuries of [14C] labeled GDC-0810 using conventional absorption,     metabolism, and excretion (AME) methodology. The entire duration of the study is up to     approximately 8 weeks.   "
36903|NCT02802657|"     The study will evaluate the efficacy and safety of two different regimens of Conbercept     (Treat-and-Extend Regimen vs. PRN) in patients with wet AMD. This study is to provide     long-term safety data in the treatment of patients with wet AMD.   "
36904|NCT02802644|"     This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after     biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.   "
36905|NCT02802631|"     This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple     ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin®     (minocycline) for injection in healthy adult subjects.   "
36949|NCT02802059|"     This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension)     probiotic bacteria administration on the number of both, bacterial and viral infections     during the first 24 months of infant's life. Half of study participants will receive     EcN-Suspension, while the other half will receive placebo.   "
48451|NCT02651428|"     The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock     solution, for prevention of central venous catheter associated bloodstream infection in     hemodialysis patients.   "
36906|NCT02802618|"     A new education material with 3D technique was developed, by integrating 3D technology in an     existing evidence-based pulmonary educational program, to enable an increased personalized     education within a group setting. The investigators believe that this educational model will     lead to increased adherence to treatment, and suggested lifestyle changes, which in turn     improves patients' HRQL      The purpose of this study was therefore to develop a pulmonary educational program in     interactive 3D visualization technology and to evaluate differences between education with 3D     technique or conventional technique in patient with COPD.      Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for     validity and reliability.   "
36907|NCT02802605|"     Prospectively evaluation of the incidence of thromboembolic events in hospitalized cirrhotic     patients. 2. Efficacy and safety of use of bemiparin in preventing peripheral and portal     thrombosis. 3. Monitoring antiXa levels.   "
36908|NCT02802592|"     EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)   "
36909|NCT02802579|"     Coronary arterial disease is a risk factor for bariatric surgery and might be a predictor for     later major adverse coronary events. Diagnosis of coronary arterial disease would thus be     desirable for obese patients, however percutaneous angiography is an invasive procedure and     associated with a certain morbidity in obese patients. In this study the investigators would     like to assess whether dual source CT angiography can be used for diagnosis of coronary     arterial disease in severely obese patients and which settings yield the best image quality.   "
36910|NCT02802566|"     The purpose of this study is to devise and pilot a BMI-based prenatal vitamin for obese     pregnant women. Currently, all pregnant women, regardless of body mass index, take the same     prenatal vitamin. The investigators have found that obese pregnant women have higher levels     of inflammation and oxidative stress, and a concomitant depletion of specific antioxidant     micronutrients. The investigators have also found, in an animal model, that decreasing     inflammation and oxidative stress during obese pregnancy was associated with improved     offspring outcomes. Here the investigators aim to understand whether a BMI-based prenatal     vitamin is effective in decreasing markers of inflammation and oxidative stress in     pregnancies complicated by obesity.   "
36911|NCT02802553|"     This is a pilot study to test and characterize the ability of the SmartGoggles system to     detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test     the sensitivity and specificity of the SmartGoggles to detect indocyanine green (ICG)     accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of     ICG (Cardio-GreenTM), under standard-of-care application conditions.   "
36912|NCT02802540|"     Anorexia is common symptom in cancer patients and is associated with increased morbidity and     mortality. However timely detection with objective tools is necessary to establish the     diagnosis of anorexia and to assess the magnitude of change over time. The anorexia     pathophysiology is not clearly understood and treatment options are limited. Anecdotal     historical benefits of smoking marijuana on nausea, pain and anorexia led to studies with     marijuana and synthetic cannabinoids from Δ-9-tetrahydrocannabinol, the main active agent in     marijuana. The endogenous cannabinoid system with its receptors CB1 and CB2 regulate appetite     in four functional levels: (1) limbic system (hedonistic quality), (2) hypothalamus (appetite     stimulant), (3) intestinal, and (4) tissue adipose.      Nabilone, a synthetic analogue of THC approved in Mexico for nausea and vomiting induced by     chemotherapy is also used in palliative care units for clinical improvement in increased     appetite patients in terminal stages, however, there are no clinical trials demonstrating     this benefit.   "
36913|NCT02802527|"     Percutaneous tracheostomy is routinely performed in most intensive care units in the     world.Several studies have shown that the procedure is safe and economically efficient in     comparison to open surgical operation in the operating room.      In the investigator's institution as in a number of institutions in the country and abroad,     it is acceptable to perform the operation either by withdrawing the endotracheal tube to a     position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a     needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the     anatomy by palpation of the neck, or alternatively by doing the entire procedure under     bronchoscopic guidance.      So far, no systematic comparison has been made between the two methods ie PDT without     bronchoscopy versus PDT with bronchoscopy.   "
37006|NCT02801318|"     Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU),     mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been     described in ICU patients and is considered as a risk factor for delirium but its role is     still unknown. It is therefore essential to identify whether sleep deprivation and more     specifically REM sleep alterations could facilitate occurence of delirium in ICU.   "
36914|NCT02802514|"     The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a     single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea     associated with Glucagon-like peptide-1 receptor (GLP-1R) agonists. This study will explore     the potential differences at the expected time of maximum concentration (Cmax) between a     long-acting (albiglutide) and short-acting (exenatide) GLP-1R agonist in brain activation of     healthy volunteers assessed by magnetic resonance imaging (MRI). This is a phase IV, 2-part,     2-period crossover (session), single dose, randomized, single blind (blinded to both the     subject and the imaging evaluators analysing the MRI data), placebo- and active-controlled     study in adult healthy volunteers who are susceptible to motion sickness. Part A and Part B     are the same in design, both consisting of a screening stage, a dosing/assessment stage, and     a follow-up visit. Data from Part A will inform progression, methods, and analysis plan for     Part B. Each sequence includes three scanning visits: albiglutide plus scan, exenatide plus     scan and an off-therapy -natural history scan with a 6-9 week washout period between the     dosing scans. A total of 24 to 28 subjects will be randomized in the study (Part A and Part     B). The cross over design is divided into 2 sessions and schedule is as follow, on Day 1     (either Session 1 (S1) or Session 2 (S2) per, if randomized) subject will under go an     off-therapy MRI scan, on Day 5 subject will receive a single dose of 50 mg albiglutide or     albiglutide placebo, and Day 8 subject will receive a single dose of 10 microgram exenatide     or saline placebo followed by a post-dose MRI scan. At each session subject will receive only     one active drug (albiglutide or exenatide).   "
36971|NCT02801773|"     The aim of this randomized placebo- controlled clinical trials is to evaluate the effects of     Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root     planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and     monitored clinically at baseline, 3 and 6 month after therapy. All patients will receive     scaling and periodontal treatment and randomly will be assigned over an experimental (SRP +     probiotic, N=18) or control (SRP+ placebo, n=18) group. The lozenges will be used once per     day during 3 month.   "
36915|NCT02802501|"     Tafenoquine (TQ) is an 8-aminoquinoline anti-malarial drug which is in development as a     single-dose treatment for the radical cure of P.vivax malaria when given with standard doses     of chloroquine. Currently, the only available drug for radical cure is primaquine (PQ) which     requires administration over 14 days, resulting in poor compliance. In Indonesia, chloroquine     has been replaced by artemisinin-based combination therapy (i.e. ACTs) due to widespread     chloroquine resistance. This study will evaluate the efficacy and safety of a single dose of     tafenoquine when co-administered with an ACT (i.e. DHA-PQP). This single-center,     double-blind, double-dummy, randomized study will test the superiority of DHA-PQP plus TQ     against DHA-PQP alone in the prevention of P. vivax malaria relapse at 6 months. The study     will be conducted in male Indonesian soldiers diagnosed with P.vivax malaria on return from     deployment to a malarious region of Indonesia. A PQ plus DHA-PQP comparator arm is included     to provide an informal comparison against the standard 14 day treatment for P.vivax malaria     in Indonesia. Subjects who are glucose-6-phosphate dehydrogenase deficient (G6PD deficient)     will be excluded due to the risk of acute hemolysis following dosing with 8-aminoquinolines     drugs. Subjects who have a recurrence of P.vivax malaria during the study will be treated     with an ACT plus PQ (0.5mg/kg for 14 days), in line with local treatment guidelines. At the     end of the 6 month follow up period, any subject who has not relapsed will be given open     label PQ (0.5mg/kg daily for 14 days) to minimize the likelihood of relapse after the study.     Approximately 200 subjects will be screened to achieve 150 randomized subjects. The total     duration of study for each subject will be 180-195 days. This study is being carried out to     support registration of TQ in Indonesia and other countries where ACTs are first line     therapy.   "
36916|NCT02802488|"     Patients with atrial fibrillation are at increased risk of thrombus formation in the left     heart, especially in the auricula and the atrium. Their presence increases the risk of     ischemic stroke, especially during cardioversion, performed either by drug or by external     electric shock. The gold standard to exclude this thrombus and consider cardioversion is the     transesophageal echocardiography.      D-dimers, products of the degradation of fibrin, have been studied several times to assess     the presence of thrombi in the body, especially in pulmonary embolism. In cardiology and     despite several studies on the matter, there is currently no blood D-dimers value allowing to     detect the presence of a thrombus with a good predictive value. Correlating the D-dimer     values with age, as has been done for some years in pulmonary embolism, would give the     opportunity to create a simple, inexpensive and widely applicable tool to eliminate the     presence of a thrombus in the left heart.      If the results are satisfactory, the investigators might consider not using transesophageal     echocardiography as this examination is unpleasant for the patient and operator dependant,     unlike a standard blood sampling.      This study aims to test the following hypothesis: D-dimers values superior or equal to ten     times the patient's age is predictive of a thrombus.   "
36917|NCT02802475|"     The Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study     focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin.   "
36918|NCT02802462|"     Exercise training improves endothelium-dependent vasodilation, whereas hypoxic stress causes     vascular endothelial dysfunction. Monocyte- derived endothelial progenitor cells (Mon-EPCs)     contribute to vascular repair process by differentiating into endothelial cells. This study     investigates how high-intensity interval (HIT) and moderate intensity-continuous (MCT)     exercise training affect circulating Mon-EPC levels and EPC functionality under hypoxic     condition. Sixty healthy sedentary males were randomized to engage either HIT (3-minute     intervals at 40% and 80%VO2max , n=20) or MCT (sustained 60%VO2max , n=20) for 30     minutes/day, 5 days/week for 6 weeks, or to a control group that did not received exercise     intervention (n=20). Mon-EPC characteristics and EPC functionality under hypoxic exercise     (HE, 100W under 12%O 2 ) were determined before and after various interventions.   "
36919|NCT02802449|"     Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive,     African-American participants will be enrolled in a 8 week study to assess the effect of two     administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical,     biologic and genetic factors. The investigators anticipate that at least 300 participants     will complete this study.      Written, signed and dated informed consent to participate in the study will be given by the     participant or a legally acceptable representative, in accordance with the International     Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable     regulations, before completing any study-related activities/procedures. The original signed     and dated consent will be kept in the subject's research file and a copy given to the     subject. A copy will also be placed in their medical record.   "
37861|NCT02790060|"     Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a     blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions     in a 2 week time period, in addition to the filling of 5 questionnaires including fear of     hypoglycemia-2 questionnaire.   "
36920|NCT02802436|"     The advent of endosseous implant restoration has driven an increasing need for alveolar bone     preservation and/or augmentation strategies. Investigations have explored the physical     scaffold effects of a wide variety of bone graft materials with each graft material offering     a more or less attractive surface for bone deposition. The seeding of these scaffolds with     biologically active material seeks to enhance the osteoconductive effect by influencing the     temporal or sequential steps which result in the desired end product-new bone.      Alveolar socket grafts are a common example of these preservation techniques. They are an     accepted procedure to maximize the retention of alveolar bone post extraction. They appear to     act as a passive scaffold for clot retention and subsequent bone regeneration.      The current pilot research project explores addition of a known Bioactive Agent: Platelet     Derived Growth Factor (PDGF) to test its impact on healing responses. Histomorphometric     assessments will be utilized on microscopic slide material derived from cores trephined as     the initial step in the preparation for placement of endosseous dental implants. Outcomes     measured will include:      Clinical observation of healing response      Microscopic measures will be        -  Measures of residual graft material        -  New bone formation and new bone contact area with graft        -  Measures of vascular content        -  Osteoclast count        -  Qualitative measures of other marrow components (Cells and relative fiber/ fat content,          liner cell characteristics.)   "
36921|NCT02802423|"     The primary purpose of this study is to determine the safety and recommended dose level (RDL)     of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The     secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with     Docetaxel monotherapy.   "
36922|NCT02802410|"     This study aims to evaluate the effects of IQ-Tape, Kinesiotaping and no Taping on muscle     activity during daily activity and sport activity.   "
36972|NCT02801760|"     This study involves a one-time, web-based quantitative structured self-complete (web-based)     survey for all subjects and a qualitative semi-structured (qualitative) interview for a     selected sub-sample of subjects to evaluate the consent processes in association with     research outcomes, specifically early adherence to Pre-exposure Prophylaxis (PrEP) and Human     Immunodeficiency Virus (HIV) seroconversion at any point during participation in the ATN 110     or ATN 113 study.   "
36923|NCT02802397|"     Early ovarian reserve decreased is one of the main causes of infertility for women after 35     years. The relationship between this decreased and exposure to chemicals, including     persistent endocrine disruptors or organic solvents, has been little studied. However,     several in vivo or in vitro experimental studies suggested that these chemicals may impaired     ovarian function.      The main objective is to study the relationship between early ovarian reserve decreased and     exposure to persistent organic pollutants.      The secondary objectives are to study the relationship between early ovarian reserve     decreased and exposure to organic solvents and heavy metals.      Multicenter case-control study. This project will permit to increase the knowledge concerning     the etiology of early decreased ovarian reserve. Considering that exposure of interest are     frequent, the results may be important in a public health perspective. If associations are     observed in this study, the results may encouraged prevention strategy.   "
36924|NCT02802384|"     Paget's disease of the bone is a skeletal disorder which results in increased and     disorganized bone remodeling, leading to dense but fragile and expanding bones. The     identified genetic causes of Paget's disease of bone only explain why bone is destroyed, but     not why the bone formed in its place is abnormal.      Current treatment for people with Paget's disease of the bone is limited to patients with     bone pain, thought to be related to high rate of bone turnover (breakdown and rebuilding of     bone) and works by slowing down the rate of bone breakdown. The current treatment does not     address the excess blood vessels and bone formed.      This research is being done to understand factors that may promote blood vessel and bone     formation in Paget's disease of the bone.   "
36925|NCT02802371|"     Caring for patients with Alzheimer Disease or Related Disorders (ADRD) is accompanied with a     caregiver burden that increases with the progression of the disease. This burden can have     physical, psychological, emotional, social and financial issue on the informal caregivers who     are often represented as hidden secondary patients. They frequently have a higher risk of     developing mood disorders as depression, anxiety, stress, sleep disorders and a lower quality     of life associated with a greater use of psychotropic drugs. They also incur higher risk of     heart disease and mortality. The embrittlement of the caregiver is a major factor of early     institutionalization of patient. In the PIXEL study, the mean age of the men caregivers was     73.9 years and 64.8 for the women caregivers. Elderly themselves, especially spouses, the     informal caregivers are also exposed to common chronic diseases and associated polypharmacy     with a higher risk of developing drug-related problems due to aging and negligence of their     own health care. These risks are increased mainly in the elderly because of changes in     pharmacokinetic and pharmacodynamic parameters related to aging, acute or chronic diseases     and the potentially inappropriate prescription (PIP). Previous studies have shown the     effectiveness and positive impact of optimization of the therapeutics by a clinical     pharmacist on the reduction of drug-related problems, length of hospital stay, readmission     rates, quality of life and mortality. The patient's medication management is usually     delegated to the informal caregiver, who must also manage his own treatment. The caregiver     may face difficulties with therapeutics (e.g., inappropriate dosage form, adverse effects and     patient refusal) that could impact on its compliance with treatment or that of his relative.     No previous study has evaluated the impact of pharmaceutical collaborative care including     personalized interview with a clinical pharmacist and optimization of drug prescribing among     patients with ADRD and their caregivers.      However, many studies have assessed the effectiveness of non-pharmacological interventions on     caregiver burden, mood disorders and the patient institutionalization. Meta-analysis showed a     moderate improvement of the caregiver burden.      The main objective of the PHARMAID study is to measure the impact of personalized     pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on     the burden of ADRD caregivers and assessed at 18-month follow-up.   "
36926|NCT02802358|"     Objectives: To describe social and health care provided to our older patients who have been     admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to     a fall. To compare among the different hospitals and town halls, the health and social care     that participants received. To compare the functional dependency and health related quality     of life (HRQoL) presented by the patients immediately and six months after a fall.      Methodology: Prospective Cohort study. One hundred and fifty patients suffering from each     type of fracture (hip or wrist) will be recruited consecutively in the Basque Health System's     participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are expected     to be collected. Data will be collected from ED and hospital clinical records and by means of     questionnaires to measure functional dependency (Barthel and Lawton indexes) and HRQoL     (SF-36) requesting information on status before the fall, immediately and six months later.     In addition to this, data referred to care provided to the patients by traumatologist,     rehabilitation or primary care provider as well as social services in their homes after the     index episode will be collected.   "
36929|NCT02802319|"     The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to     examine histologic wound healing following ridge preservation using bovine xenograft and     porcine xenograft materials.This protocol involves procedures that are standard care. All     materials are FDA-approved materials being used in an FDA-approved manner. The test group     subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group     will be compared to an active control group using bovine xenograft (Bio-Oss). The null     hypothesis is that there will be no significant difference in formation of new vital bone     between treatment groups (primary outcome).      Each subjects will have a non-molar tooth extracted and the socket grafted with either test     or control graft material. At the time of dental implant placement 18-20 weeks after tooth     extraction a small core biopsy specimen will be removed from the implant site. The core     biopsy will then be evaluated for the primary histologic outcome of % vital bone formation     and secondary histologic outcome of % residual graft material.   "
36930|NCT02802306|"     This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded     study designed to investigate the safety and efficacy of the Tack Endovascular System. This     study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in     the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths     of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will     also evaluate the safety and efficacy of the device when used to treat a sub-group presenting     with longer lesions of >150mm and ≤250mm.   "
36931|NCT02802293|"     The purpose of this study is to determine the clinical effects (if any) of     connectivity-guided repetitive transcranial magnetic stimulation (rTMS) in the treatment of     major depressive disorder (MDD) to provide clues about the ideal neural networks to target     for more robust clinical outcomes, and to identify potential biomarkers of treatment response     including changes in brain network connectivity.   "
36932|NCT02802280|"     Hypothesis: In addition to the liver deleterious effects, Chronic Hepatitis C (CHC) can cause     changes in other organs highlighting the increased cardiovascular risk (CVR) through     accelerated atherosclerosis, whose consequences may persist even after healing infection with     new antiviral treatments. This can have major impact on the health system. Obtaining a     Sustained Virological Response (SVR) with a free Interferon (IFN) antiviral treatment is     probably able to reverse, at least partially, increased vascular risk induced by Hepatitis C     virus (HCV) and perhaps ultimately reverse the subclinical atherosclerosis.      Aims: To study the presence of early-subclinical atherosclerotic disease (endothelial     dysfunction and subclinical atherosclerosis) in patients with CHC and evaluate the influence     of treatment in the short and medium term on the CVR derived. Studying these same issues but     in patients with established atherosclerotic disease.   "
36933|NCT02802267|"     Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall     survival in previously untreated AML patients aged 65 years or more who are randomly assigned     to receive decitabine with or without inecalcitol.   "
36934|NCT02802254|"     The aim of this study is to evaluate the efficiency of a minimal intervention on risk     perception of physical inactivity in patients with known coronary heart disease (CHD) and     patients at risk for CHD. Therefore half of the patients (intervention group) get a personal     feedback on their individual level of physical activity measured by pedometers and     self-report questionnaires plus information about the risk factor 'physical inactivity' for     heart diseases. Following the hypotheses the feedback should increase the patients risk     perception of physical inactivity and furthermore increase physical activity.   "
36935|NCT02802241|"     The purpose of this study is to investigate placebo effects and peppermint oil in Irritable     Bowel Syndrome.   "
36936|NCT02802228|"     This placebo-controlled study will assess the safety and efficacy of a 90-day course of     treatment with ifetroban for portal hypertension in cirrhotic patients   "
36937|NCT02802215|"     Randomized, placebo controlled clinical trial that evaluate the role of taking metformin     therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the     development of gestational diabetes(GDM) and improving pregnancy outcomes.   "
36938|NCT02802202|"     To date, there are no valid and reliable pressure pain threshold scales for use in research     or clinical practice. The existing manual palpation protocols and scales have limited support     in the literature and our knowledge has not advanced since these scales were proposed in the     1990's. Therefore, the purpose of this investigation was to develop a valid and reliable PPTS     in order to provide an objective means of assessing pressure pain thresholds and create a     reliable method of communication among clinicians for individuals with a diagnoses     characterized by MPS and FM. These conditions were chosen based on their high prevalence     among chronic pain conditions and are also dependent upon the manual palpation examination     for their diagnosis.   "
36939|NCT02802189|"     The purpose of this study is to examine the combine effect of the integrated neuromuscular     inhibition technique (soft tissue mobilization techniques protocol), in combination with the     therapeutic exercise in patients with chronic mechanical neck pain in the sub-acute stage of     symptoms, and to determine whether this combination substantially helps the faster and more     efficient installation of adaptations of exercising.   "
36940|NCT02802176|"     The purpose of this study is to evaluate implantation rate with intra-vaginal culture with     the INVOcell device versus traditional IVF while using minimal stimulation protocols   "
36941|NCT02802163|"     The purpose of this study for Phase l is to determine the maximum tolerated dose of     panobinostat given in combination with carfilzomib, lenalidomide, and dexamethasone in 28-day     cycles as induction (initial) therapy to participants with newly diagnosed multiple myeloma.      In Phase ll, investigators will evaluate the safety (side effects) and efficacy     (effectiveness) of panobinostat in combination with carfilzomib, lenalidomide, and     dexamethasone.   "
36942|NCT02802150|"     The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral     consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.   "
37007|NCT02801305|"     Digital ulcers are one of the most prevalent complications of scleroderma (systemic     sclerosis). There can be found few surveys on effect of topical agents on healing process of     the ulcers. Thus, the aim of this study is to assess and compare the effects of topical     diltiazem on SSc digital ulcers versus topical nitroglycerin.   "
36943|NCT02802137|"     The study investigated the 24-hour efficacy and ocular surface health with preservative-free     tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol fixed     combination) in open-angle glaucoma patients insufficiently controlled on latanoprost     monotherapy and showing signs, or symptoms of ocular surface disease with     preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma     patients insufficiently controlled (IOP > 20 mm Hg) on branded, or generic latanoprost     monotherapy who required further IOP reduction and who demonstrated clinical signs, or     symptoms of ocular surface disease.   "
36944|NCT02802124|"     The aim of this research project is to assess the feasibility and safety of carbon-ion     radiotherapy for the treatment of localized Chinese hepatocellular carcinoma   "
36945|NCT02802111|"     Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction.     Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R     form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The     investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR)     following administration of albuterol and   "
36946|NCT02802098|"     This is a single-arm pilot proof of concept, open-label clinical trial. Twenty-five subjects     will be enrolled in 6 sites.      Metastatic breast cancer patients with disease progression to bevacizumab-alone maintenance     treatment will be potential candidates.      Bevacizumab maintenance will be considered as six weeks of bevacizumab treatment in     monotherapy after the last dose of chemotherapy in the context of bevacizumab plus     chemotherapy first-line regimens.      When progression to bevacizumab-alone maintenance treatment occurs, patients will enter the     trial and will start receiving DURVALUMAB 750 mg (equivalent to 10 mg/kg Q2W) IV infusion, if     ≥ 30 kg, every 2 weeks together with bevacizumab 15mg/kg IV infusion every 3 weeks. The     patients will undergo a tumor biopsy before the first dose of DURVALUMAB, and after one month     of combined treatment - the blood sampling will continue on a monthly basis. The treatment     will continue until disease progression or for a maximum of 50 weeks.   "
49155|NCT02642224|"     Primary outcome: Research participants and their network contacts will be followed over 6     months to assess whether a social work case management protocol results in reduction of     trauma services recidivism and criminal violence arrests.   "
36950|NCT02802046|"     Angina pectoris is the most common clinical manifestation of coronary heart disease（CHD）,     which is the main feature of chest pain caused by transient myocardial ischemia. Chronic     stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in     patients with no significant change in a few weeks. The disease incidence is complex,     difficult to diagnosis and treatment, clinical should be combined with various inspection     methods for diagnosis and differential diagnosis. Fractional flow reserve of computerized     tomographic scanning (FFRCT ) allows computerized tomographic scanning（CT） to scan the     determination of coronary blood flow and blood pressure in the heart at rest and hyperemia,     but no need to additional check or drugs. This technique has been used for noninvasive     fractional flow reserve (FFR) in the calculation, assuming normal artery, calculated by the     ratio of the maximum blood flow and blood flow of coronary artery stenosis of an artery.     Along with the development and progress of computational fluid dynamics, in the resting state     by computed tomographic angiography of coronary artery(CCTA) image data based, simulation of     coronary artery maximal hyperemia and according to the 3-dimensional model of the traditional     method of reconstruction of coronary arterial tree and ventricular muscle structure, and in     order to calculated coronary blood flow and pressure. FFRCT is a novel non-invasive     examination method, using computed tomographic angiography of coronary artery image data can     be calculated FFR, and preliminary study proved that it has a high degree of correlation with     traumatic FFR. Therefore, this study aims to evaluate the correlation between the degree of     coronary stenosis and the grading of angina pectoris by noninvasive means --FFRCT, in order     to provide a new idea for the diagnosis and differential diagnosis of coronary heart disease.   "
36951|NCT02802033|"     Details regarding the degenerative spine disorders will be collected with a specific focus on     the use of osteobiologics in treating degenerative conditions and their impact on fusion, as     well as patient-reported outcomes for these conditions.   "
36952|NCT02802020|"     To prospectively document the performance of a FCSEMS for treatment of pancreatic duct     strictures in patients with painful chronic pancreatitis.   "
36953|NCT02802007|"     This is a prospective, non-randomized, open trial to be conducted in overweight and obese     individuals. The primary objective is to evaluate the safety of the Elipse™ Intragastric     Balloon System for the treatment of overweight and obese individuals. The secondary objective     is to collect efficacy and device performance information to assist with future trial design     and device iterations.   "
36954|NCT02801994|"     Rational. The mismatch between the activity of the respiratory muscles and the assistance     delivered by the ventilator results in patient-ventilator disharmony, which is commonly     observed in ICU patients and is associated with dyspnea and patient-ventilator asynchrony.     Both dyspnea and asynchrony are in turn associated with a worse prognosis. Unlike     conventional modes of mechanical ventilation, such as pressure support ventilation (PSV) that     deliver a constant level of assistance regardless of the patient effort, Proportional     Assisted Ventilation (PAV) adjusts the level of ventilator assistance to the activity of     respiratory muscles. To date, data on the impact of PAV on dyspnea and patient ventilator     asynchrony are scarce and most studies have been conducted in healthy subjects or in ICU     patients who had no severe dyspnea nor severe asynchrony. To our knowledge, there are no data     in patients with severe patient-ventilator dysharmony.      Study Aim. To evaluate the impact of PAV on dyspnea and patient-ventilator asynchrony in ICU     mechanically ventilated patients in intensive care with severe patient-ventilator disharmony     defined as either severe dyspnea or severe patient-ventilator asynchrony.      Patients and Methods. Will be included 24 ICU mechanically ventilated patient exhibiting     severe patient-ventilator dysharmony with PSV. The intensity of dyspnea will be assessed by     the VAS, the ICRDOSS and by the electromyogram of extradiaphragmatic inspiratory muscles and     pre inspiratory potential collected from the electroencephalogram. The prevalence of     patient-ventilator asynchrony will be quantified.      Expected results. It is anticipated that the switch from PSV to PAV will decrease the     prevalence and severity of dyspnea and the prevalence of patient-ventilator asynchrony.   "
36955|NCT02801981|"     This study will be the first to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in     Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled,     dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy     subjects. Study will be conducted in four periods; subjects will receive either placebo or     GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period.     Each period will be separated by washout period (at least 6 days from dosing). Total duration     of study for each subject will be approximately 5 weeks from the first dosing to follow up     visit.   "
36958|NCT02801942|"     It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes     Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes     (iLN), which will be distinct from changes observed in peripheral blood derived immune cells.     Therefore this study will assess and compare the molecular immune profile of cells derived     from the iLN in healthy and NOT1D subjects, to understand the immunological processes that     may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15     subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the     study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy     subjects, to determine if the quality and quantity of cells derived from aspirate or core     biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its     primary objective.   "
36959|NCT02801929|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
36960|NCT02801916|"     Viscous dietary fibers including oat β-glucan are one of the most effective classes of     functional food ingredients for reducing postprandial blood glucose. The mechanism of action     is thought to be via an increase in viscosity of the stomach contents that delays gastric     emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose     absorption. Previous studies suggest that taking viscous fibers separate from a meal may not     be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the     effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g)     containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal     of white bread on glycemic responses in 10 healthy humans.   "
36961|NCT02801903|"     This is a 21 day, single-center, open-label pharmacokinetic, safety and tolerability study in     adolescents with moderate to severe acne vulgaris.   "
36962|NCT02801890|"     Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's     the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using     the potential features of MSCs in the treatment of fibrosis may offer new insights into     reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten     peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion     effects in clinical, cellular and molecular levels.      So in this trial, we will evaluate the effects of this intervention after intravenous     injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis     patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the     control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after     first injection.   "
36963|NCT02801877|"     This study will evaluate and compare a smartphone intervention for depression and anxiety     that uses machine learning to tailor treatment for participants with the same intervention     without the machine learning component. The intervention, referred to as IntelliCare,     delivers participant-specific treatment material and motivational messaging via a mobile     phone to help individuals with depression and/or anxiety. Information and data received from     the participant will inform the tailored treatment approach through machine learning. The     purpose of this study is to compare different versions of the main IntelliCare Hub App (the     centralized program delivery system) and participant user experience whether with the support     of a coach or used independently. The RCT aims to obtain information on the feasibility and     effectiveness of IntelliCare in improving symptoms of depression and anxiety.   "
36964|NCT02801864|"     The purpose of this study is to determine if transcranial direct current stimulation (tDCS)     in conjunction with intensive speech therapy will improve sentence production and word     retrieval in individuals with chronic post stroke aphasia.   "
36965|NCT02801851|"     This study will refine and pilot test an innovative, emergency department (ED)-based     intervention for delirium screening, initial management, and communication with inpatient     providers, and examine the impact of this intervention on the rate of documentation of     delirium in the electronic health record by ED and inpatient providers. To achieve this, the     study will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED,     involving 300 older patients (150 newly enrolled intervention participants, 150 historical     controls (comparison group) currently being collected), that has 4 key components: systematic     screening for delirium using the Confusion Assessment Method (CAM), informing providers of     the screening result, a checklist protocol for initial delirium management based on clinical     guidelines, and documentation in the Electronic Health Record (EHR) and communication with     inpatient providers of delirium screening results.      The study has two primary aims. The first is to refine and test the feasibility and     acceptability of the SCREEN-ED intervention. The second is to examine the impact of SCREEN-ED     on rate of delirium documentation and secondary outcomes (length of hospital stay, repeat ED     visits and hospitalizations and mortality over 6-months) in the 150 newly enrolled     intervention group compared with 150 already collected historical controls.   "
36966|NCT02801838|"     Background : Dyspnea is common and severely impact mechanically ventilated patients outcomes     in intensive care unit (ICU). Recognize, measure and treat dyspnea have become current major     therapeutic challenge. Its measurement involves a self-assessment by the patient, and by     definition, a certain level of communication. Consequently, a large proportion of the     ICU-population (non-communicating) misses its evaluation and potential benefits associated     with its control. In other hand, electrophysiological markers that help to detect and     quantify dyspnea regardless of the patient's cooperation, has been developed and validated as     dyspnea surrogate, namely: 1) the electromyographic (EMG) activity of extra diaphragmatic     inspiratory muscles and 2) the premotor inspiratory potentials (PIP) detected on the     electroencephalogram (EEG). Because of its complex implementation in daily practice the     research team has developed alternatively a behavioral score called IC-RDOS that provides     reliable dyspnea assessment also without patient participation. Validated in conscious     patients, it has not been yet validated in non-communicating patients.      Hypothesis : The IC-RDOS is valid for non-communicating ventilated patients and allows a     simple and reliable assessment of dyspnea in this specific population.      Objective : To validate the IC-RDOS in non-communicating ICU patients under mechanical     ventilation, using comparison with the tools validated for reliable measure of dyspnea in     non-communicating patients (EMG, EEG).      Patients and Methods: In 40 patients will be collected simultaneously IC-RDOS, PIP (EEG) and     electromyographic activity of three extra diaphragmatic inspiratory muscles (scalene,     parasternal and Alae nasi) before and after intervention therapy aiming at reduce dyspnea     (ventilator settings or pharmacological intervention), initiated by the clinician in charge     of the patient.      Expected results : Observe a strong positive correlation between the IC-RDOS and     electrophysiological markers (amplitude of the electromyogram and presence and magnitude of     PIP). Observe a correlation between changes in the IC-RDOS and the electrophysiological     markers after therapeutic interventions.      Optimizing patient comfort is a prominent concern in the ICU. By optimizing the detection and     quantification of dyspnea in non-communicating patients, this study should ultimately improve     the management and the better living of ventilated patients in intensive care   "
36967|NCT02801825|"     The main purpose of the study is to compare two ultrasound-guided arterial cannulation     procedures: in-plane infraclavicular axillary artery cannulation and out-of-plane femoral     artery cannulation.   "
36968|NCT02801812|"     The purpose of this study is to investigate the role of nailfold capillaroscopy in the     assessment of patients with Systemic Lupus Erythematosus (SLE).      Primary endpoint:      - To compare the frequency of major capillaroscopic abnormalities in patients with SLE and     healthy controls.      Secondary endpoints:        -  To compare the frequency of major capillaroscopic abnormalities in patients with active          and non-active SLE / active SLE and healthy controls / non-active SLE and healthy          controls.        -  To study the association of different capillaroscopic parameters and the status of          subjects (SLE / active SLE / non-active SLE / healthy controls).   "
36969|NCT02801799|"     This trial is a part of the project: 'A novel technique for reliable, precise and safe     postoperative pain management' (project no. 65-2014-3).      The purpose of the trial is to investigate the effects of changing peri-neural infusion rates     of ropivacaine 0.2% on the duration of nerve block.      Intervention:      Two intervention-days. Each day a peri-neural infusion of a fixed volume of ropivacaine 0.2%     is to be infused in one of five infusion rates, using a peri-neural catheter.      Intervention day 1: Focus on the common peroneal nerve. Intervention day 2: Focus on the     sciatic nerve.   "
36970|NCT02801786|"     This is a double-blind placebo-controlled randomized clinical trial to test the use of     tamoxifen or lidocaine for diminishing the pain and discomfort while performing mammography,     intending to include 450 patients distributed between the three groups.   "
36989|NCT02801539|"     This study is being done to test the effects of respiratory muscle training (RMT) in patients     with late-onset Pompe Disease (LOPD) who have weakness of their breathing muscles. The     results of this study will help design future research studies about RMT in LOPD. The goals     of this study are to decide if sham-RMT is a useful control condition for RMT and to choose     the best ways to measure the health benefits of RMT in LOPD.   "
36973|NCT02801747|"     The present study targets the large population of persons living with HIV/AIDS (PLHA) in the     U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral     therapy (ART), who are mainly African American/Black and Latino. NIH has emphasized the     urgent need for new research approaches to advance intervention science, and the proposed     project employs a new, potent, and innovative research methodology, the Multiphase     Optimization STrategy (MOST), a framework for developing highly efficacious, efficient,     scalable, and cost-effective interventions. The proposed study has the highest public health     significance: it addresses a vulnerable population of PLHA, including the critically     important subpopulations of men who have sex with men (MSM) and substance users; will develop     an efficient and cost effective intervention to increase engagement along the HIV care     continuum for these vulnerable groups; and addresses two areas highlighted in the August 2015     notice on research priorities from the NIH Office of AIDS Research (NOT-OD-15-137), namely,     engaging PLHA in prevention/treatment services, and reducing HIV/AIDS-related racial/ethnic     disparities.   "
36974|NCT02801734|"     i. Project Background Patients with advanced lung cancer have a high symptom burden and low     quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced     lung cancer patients, but previously tested models are not feasible for widespread adoption.     Hence, the aim of this study is to pilot a more sustainable nurse-led intervention -     Enhancing Quality of life in Patients (EQUIP).      ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to     determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the     investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention.     Thirdly, the investigators aim to determine the data completion rate of patient reported     outcome measures in the context of the EQUIP trial.      iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited     and randomized to the EQUIP intervention or usual care (control) group. Patients randomized     to the EQUIP intervention group will receive four face-to-face sessions with a palliative     care nurse. The content of these educational sessions will equip patients with the knowledge     and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.      All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L),     the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points:     baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be     recorded. Additionally, participants in the intervention group will complete a feedback     survey after each intervention session.      A total sample of 60 patients (30 in each arm) will be recruited.      Clinical Significance      If successful, this study will lead to a larger scale phase III trial which tests various     components of the EQUIP intervention, in order to develop a sustainable and effective model     for the provision of palliative care to advanced lung cancer patients.   "
36975|NCT02801721|"     1. Burden: Anaemia is a public health problem in our country. Fifty one percent young          children aged 6 to 59 months are suffering from anaemia in Bangladesh (BDHS-2011) and          the main cause of this problem is iron deficiency. Research findings show that Iron          deficiency leads to delayed development and even reduce working capacity. All these          impact negatively on quality of life and loss of national gross domestic product (GDP).        2. Knowledge gap: Little is known about long-term effects of early life iron deficiency          anemia on development and behaviour of children after correction with iron supplements.          There is also scarcity of information if early life psychosocial stimulation added to          iron supplementation to these anemic children have long term benefits compared to          non-stimulated anaemic children or non-anaemic children        3. Relevance:           The aim was to conduct a follow up study to examine whether the IDA children, who          recovered from iron deficiency and received additional more intense psychosocial          intervention catch up to their optimum development in later life at school age, similar          like non-anaemic peers.        4. Hypothesis (if any):             1. The benefit of early iron supplementation in addition to Psychosocial stimulation               on growth and development of IDA infants appears in later life.             2. Addition of early psychosocial stimulation in treated IDA children help them catch               up to their non-anemic peers in development over time.        5. Study Objective(s)             1. To determine the long term effect of early psychosocial stimulation provided at the               age of 6-24 months in addition to iron treatment in IDA children on their growth               (height, weight and Head Circumference), IQ, executive function, school               achievement, fine motor, memory and behaviour             2. To compare the growth and development of IDA infants with non-anemic infants after               7 years of an intervention with iron supplementation and psychosocial stimulation.        6. Methods:      Sample: All children who participated in the iron and stimulation study at the age of 6 to 24     months (n=424).      Identification of sample: Using the addresses and by tracking through available mobile phone     numbers.      Measurements      In the current follow-up, at the age of around 8-9 years all the available children will be     measured for:        -  WASI: The Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)        -  School achievement        -  Number Stroop        -  SDQ (strength and difficulties):The Strengths and Difficulties Questionnaire (SDQ)        -  Memory test of NEPSY (neuropsychological test)        -  Digit span forward and backward        -  Middle childhood HOME        -  Fine motor skills using the Purdue peg board or Movement Assessment Battery Children- 2          (age -band 2 for 7-10 years)        -  SES Anthropometric measurement: Children's height, weight and head circumference   "
36976|NCT02801708|"     The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for     detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or     transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical     work up including an initial 24-hour Holter monitoring.   "
37004|NCT02801344|"     Protein requirements in individuals who participate in endurance-based exercise training have     been suggested to be greater than the current recommended dietary allowance (RDA).      Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique     have suggested that protein requirements in young men are at least 30% higher than the     recommended protein intake.      The present study will investigate the impact of protein sufficiency on protein metabolism     and performance during intensified training periods as a means to further our understanding     of the nutritional requirements for the endurance athlete.   "
36977|NCT02801695|"     Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and     fetal morbidity and mortality. The early clinical manifestations are the occurrence of a     maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to     the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a     disease that causes prematurity and currently the only known cure is delivery of the     placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia     is directly related to a failure of placental NO production. In this context, several     clinical trials have tested the effect of NO donors such as L- arginine. However,     supplementation with L -Arginine in a randomized trial in Nantes, has proved to be     ineffective in severe vascular IUGR.      Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes     uptake in the liver and appears directly in the peripheral blood converted by the kidney in     arginine, released into the systemic circulation, Citrulline may therefore be more effective     in the treatment of pre-eclampsia.      This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy     for patients with pre-eclampsia before 36 weeks.   "
36990|NCT02801526|"     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330     (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of     the two separate drugs in healthy male volunteers.   "
36991|NCT02801513|"     Despite considerable progress in the understanding of depression, the treatment of those who     have entered a chronic course of the disorder still represents a major challenge. In order to     develop more effective interventions it is important to learn more about maintaining     mechanisms and the ways in which these can be addressed. Recent research has outlined     aberrations in neurophysiological parameters that may serve as risk factors underlying     tendencies to engage in maladaptive responses to negative mood, and that may be particularly     pronounced in patients with chronic depression. Initial evidence suggests that such deficits     may not be easily amenable through established treatments. The current study investigated     whether mental training using mindfulness mediation, as compared to an active control     training, could alter these parameters in chronically depressed patients.   "
36992|NCT02801500|"     The purpose of this study is to determine whether the magnetic compressive anastomosis has a     better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.   "
36978|NCT02801682|"     Invasive Candida infections are serious complications in immunocompromised patients including     those undergoing treatment for cancer but occur also in patients treated in ICUs. Survival     rate of invasive candidiasis is associated with early initiation of antifungal therapy (15%     mortality rate for candidemic patients with antifungal therapy on day 0 related to the     culture date of the first blood sample positive for yeasts compared to 41% for patients who     received antifungal therapy on day 3). Up to date, no laboratory method or clinical decision     rule is available for correct anticipation of invasive candidiasis which would avoid delays     in appropriate antifungal therapy initiation. In clinical practice culture based methods     (e.g. blood cultures) miss up to 50% of invasive candidiasis cases. Preemptive antifungal     therapy is therefore often initiated in critically ill patients after Candida has been     isolated from various non-sterile patient samples even without any sufficient evidence for     invasive candidiasis. The disadvantages of this approach include over- and undertreatment of     patients (up to 50% of candidemia cases are missed, and on the other hand 89% patients are     treated unnecessarily), increased selective pressure for the development of antifungal     resistance, potential risk of adverse drug reactions, and increased costs (expenses for     antifungal therapy account for half of the antimicrobial medication budget in tertiary care     hospitals). In addition, no survival benefit could be demonstrated by this strategy in ICU     patients.      The aim of this study is to identify biological markers to anticipate or support the     diagnosis of invasive candidiasis in ICU patients, to overcome current deficiencies in     detection of invasive candidiasis and consequently to differentiate between Candida spp.     colonization and invasive Candida infection. The investigators intend to examine time     dependent courses of potential host and pathogen derived biomarkers as well as innate or     acquired predispositions for invasive candidiasis; e.g. automated (1→3) ß- D- Glucan tests,     DNA in serum blood samples, pathogen recognition receptors and serum markers like interleukin     (IL)-1, IL-2, IL-6, IL-10, IL-12, IL-17A, IL-17F, IL-22, IL-23, Tryptophan, Kynurenine,     composition of indigenous microbiota of gastrointestinal and lower respiratory tract and     skin, and risk factors for invasive candidiasis like underlying diseases and treatments. The     study should contribute to improved assessment of ICU patients at risk for invasive     candidiasis and to improved diagnosis of invasive candidiasis in ICU patients. In clinical     practice the reliable differentiation between infection and colonization will allow more     targeted antifungal therapy leading to enhanced antifungal treatment initiation on the one     hand (in cases of true invasive candidiasis) and to reduction of unnecessary antifungal     treatments and treatment costs on the other hand.   "
36979|NCT02801669|"     The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with     non-valvular NVAF aged 80 years or older who are ineligible for available oral     anticoagulation therapy.   "
36980|NCT02801656|"     Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and     mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to     kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal     microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in     recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize     patients to oral encapsulated FMT or oral Vancomycin.   "
36981|NCT02801643|"     The present study would be the first to investigate the relationship between reward- and or     social stimuli-induced dopamine (DA) release and neural function using a combined PET/fMRI     approach. Data from this project conducted in healthy subjects will provide preliminary data     for a larger grant application to study patient populations with known abnormalities in DA     including schizophrenia, major depressive, substance use, and eating disorders.   "
36982|NCT02801630|"     This is a double blinded randomized control trial of a Surface Acoustic Wave Patch device for     the treatment of Trigeminal Neuralgia. This will be a crossover study for the group that     receives the sham device. Subjects will be monitored for subjective criteria of pain and     quality of life, as well as objective measurement of analgesic usage.   "
36983|NCT02801617|"     Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by     Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensor     therapy in subjects with primary open angle glaucoma or ocular hypertension.      Study design: a muticentric, prospective, crossover (2x2), double blind clinical study.     Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.     Patients in the period 1: In the first sequence 50 patients will be assigned to receive the     ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop QD during 30 days and the     second sequence 50 patients will be assigned to receive the ophthalmic solution: PRO-067 1     drop QD during 30 days in the same period. Washout period: 21 hours. Patients in the period     2: the pharmcological intervention change to the opposite therapy for 30 days.   "
37005|NCT02801331|"     The purpose of this study is to examine the efficacy of a specially-constructed crib mattress     that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary,     non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids     in utero.   "
36984|NCT02801604|"     The practicality of most ADHD medications is not or only moderately examined under long term     routine conditions. Therefore, in this multi-centre, multi-national prospective     non-interventional study, a recommended follow-up time of 12 months will investigate the     course of the therapy in children and adolescents with ADHD with prior MPH treatment and     their medication change to dexamfetamine in several European countries under daily routine.      It consists of a baseline visit under MPH or another ADHD drug therapy, a change to     dexamfetamine, the prospective description of the titration phase and a 12 month maintenance     phase. Data on the use of dexamfetamine in routine clinical practice will be collected to     describe how dexamfetamine is prescribed, titrated and used in the population of ADHD     patients and how these factors influence the general intensity of ADHD and safety events.     This study will collect real world data of dexamfetamine and compare descriptively the     general intensity of ADHD according to ADHD classification and the impairment due to ADHD     under therapy with dexamfetamine to the general intensity of ADHD according to ADHD     classification and the impairment due to ADHD under the prior therapy with MPH. Furthermore     the utilization of dexamfetamine will be assessed with regards to treatment persistence,     compliance, proportion of patients discontinuing treatment and reason for discontinuation.     Due to the fact that patients will be treated according to local medical practice it is     possible that medication will be changed during the observation period.   "
36985|NCT02801591|"     Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection     assisted in the treatment of the patients with poor ovarian response in vitro fertilization     and embryo transfer.   "
36986|NCT02801578|"     Ibrutinib is currently FDA approved and commercially available for the treatment of CLL.     However, some researchers think the approved dose may be unnecessarily high.      The goal of this clinical research study is to compare 3 different daily doses of ibrutinib     to learn how these doses affect the disease and your body. Researchers think that if a lower     dose of ibrutinib can be found to be as effective as the currently approved dose this may     help to lower the risk of side effects.   "
36987|NCT02801565|"     Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro     fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.   "
36988|NCT02801552|"     This study evaluates the clinical effect of regenerative endodontic procedure using PRF in     immature permanent teeth with apical periodontitis. Half of participants will receive the PRF     instead of blood clots in the regenerative endodontic procedure, while the other half will     receive a blood clots in the regenerative endodontic procedure.   "
36993|NCT02801487|"     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation     using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of     locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment     at the MTD. Participants will be treated with CIRT with escalating dose regimens along with     concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in     terms of acute and subacute toxicity observed during and within 4 months after the completion     of concurrent chemoradiotherapy. Once the MTD for locally recurrent NPC is determined, the     MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the     Phase II part of the trial.   "
36994|NCT02801474|"     Patients with a posterior malleolar fracture were recruited and assigned to the direct     reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation     of the fracture, the quality of fracture reduction was evaluated in radiograph and CT images.     Functional outcome was evaluated at the last follow-up.   "
36995|NCT02801461|"     The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.     The purpose of this study was to assess the effect of extracorporeal shock wave therapy on     cubital tunnel syndrome.   "
36996|NCT02801448|"     Type 2 diabetes (T2D) results from a combination of insufficient insulin secretion from     pancreatic islets and insulin resistance of target cells. The investigators have extensive     pre-clinical data suggesting that BSE through its high content of the isothiocyanate     sulforaphane improves hepatic insulin sensitivity. BSE as a dietary supplement could     therefore benefit both patients with T2D and individuals at risk for the disease.     BSE-containing sulforaphane is suggested to activate Nuclear factor-like 2 (NRF2). The     investigators aim to study the clinical effect of using BSE as a dietary supplement on     glucose tolerance and insulin sensitivity.   "
36997|NCT02801435|"     This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib     Hydrochloride Cream in patients with mild to moderate psoriasis.   "
36998|NCT02801422|"     The aim of this fMRI study is to investigate neural indices of relapse in cannabis     dependence. The development and maintenance of drug addictions have been associated with     deficits in cognitive control, craving and impaired stress regulation. Therefore, neural     markers of brain processes underlying the beforementioned components will be studied.     Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis     dependence and alterations in brain networks of cognitive control, craving and stress.   "
36999|NCT02801409|"     Some studies suggest that regional anesthesia/analgesia may decrease the rate of     recurrence/metastasis in patients after cancer surgery. However, evidences from prospective     studies are still lacking. The purpose of this randomized controlled trial is to investigate     the effect of epidural anesthesia/analgesia on the rate of recurrence/metastasis in patients     undergoing lung cancer surgery.   "
37000|NCT02801396|"     Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses     bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will     complete a questionnaire for each study lens.   "
37001|NCT02801383|"     to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for     the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV     type infections and clinical negative conversion.   "
37002|NCT02801370|"     This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study     in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a     single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external     auditory canal of the affected ear(s).   "
37003|NCT02801357|"     The purpose of this study is to evaluate the relative exposures of lofexidine and its major     metabolites in subjects seeking buprenorphine dose reduction.   "
37010|NCT02801266|"     This project develops a contraceptive counseling protocol (CCP) grounded in scientific     evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended     pregnancy among women. The project develops and refines the CCP using focus groups and     in-depth interviews with (a) key administrators in the national office of Planned Parenthood     (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and     (d) clients of the health centers. The CCP uses scientifically grounded principles for     guiding effective decision making and provider-client communication. Ten Title X clinics are     randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual     (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study     participation in each clinic, yielding about 1,400 participants (half control and half CCP).     Immediately following their counseling session, women complete a computer-administered     interview that serves as a fidelity check and permits evaluation of the effects of the CCP on     variables associated with counseling satisfaction. All women are re-interviewed by phone 6     months later and 12 months later. The effect of the CCP on method-choice effectiveness,     method switching, gaps in protection, and use accuracy are evaluated.   "
37011|NCT02801253|"     Management of prosthetic joint infections (PJI) is a challenging task. These infections     include different clinical and microbiological settings calling upon various treatment     strategies according to infection type (acute or chronic), bone quality, the involved     micro-organism and the patient's general condition and willing.      Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a     high operative risk prolonged suppressive antibiotic therapy can be used.      Lack of large prospective studies motivated the conception of this cohort with a long term     follow up, regardless to PJI management procedures.   "
37012|NCT02801240|"     Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized,     open-label study will assess the effect of a nutrition support product on nutritional status     in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be     enrolled in the study and asked to take the product for 12 weeks. The primary measures of the     study are several blood markers of nutritional status.   "
37013|NCT02801227|"     The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding     time from induction of labor (IOL) to delivery among primiparas at term with prelabor rupture     of membrane (PROM) and an unfavorable cervix.   "
37014|NCT02801214|"     This fMRI study investigates neural correlates of emotion regulation, emotion processing and     craving in recreational cannabis users.   "
37015|NCT02801201|"     At the time of birth, nearly 5% of children are in breech presentation. This type of     presentation requires a medical environment and leads to more frequent use of Caesarean     sections. This is why the external version can be proposed, usually from the 36th week. Its     success rate is 40%, and is usually performed under simple sedation. One of the causes of     failure is the lack of relaxation of the uterus, which could be higher in case of deeper     anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate     superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary     and secondary objectives.   "
37016|NCT02801188|"     Fracture femur is a common that results in severe pain. Many methods of regional and     peripheral analgesia have been described to treat such pain. In this study the investigators     consider using paravertebral block to treat post-fracture pain. Additionally, they consider     adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this     block and hence postoperative analgesia.   "
37017|NCT02801175|"     Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation     either with radiofrequency (RF) or cryoballoon will be included. Left atrial appendage     emptying flow velocity (LAA-EFV) will be measured with transesophageal echocardiography (TEE)     immediately before and following left atrial ablation (1 month post). The change in LAA-EFV     will be compared between the two groups (RF versus Cryo).   "
37018|NCT02801162|"     Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative     clinical data at various time points. Compare the methods associated with obtaining blood gas     results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the     investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system     parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing     context.   "
37019|NCT02801149|"     Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid     fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often     challenging, particularly at the time of presentation, this study aims to evaluate whether     the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with     a suspected scaphoid fracture, with negative findings from the initial conventional     radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care and     patient experience.      This study is a single centre randomised, non-blinded, prospective study. Participants will     be randomised, following the initial negative conventional radiography, to either: no further     imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The study     considers a follow-up period of 6 months.   "
37020|NCT02801136|"     This research study is examining the effects of a cognitive behavioral intervention (an     intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic     seizures (PNES, episodes resembling epileptic seizures but with no medical explanation).     Participants engage in 8 individual therapy sessions consisting of either cognitive     behavioral therapy or supportive therapy. Healthy control participants also complete     pre-questionnaires.   "
37045|NCT02800785|"     For the past 130 years, appendectomy has been the standard treatment for appendicitis. Recent     studies from Europe have challenged the notion that surgery is the best option, showing that     antibiotics alone can treat appendicitis without a need for appendectomy in as many as 3 out     of 4 patients and without safety issues for up to one year of follow up. Despite these     results, it remains to be determined if the antibiotic strategy is as good as an appendectomy     for the outcomes that most patients care about. The Patient-Centered Outcomes Research     Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy (CODA) trial will     be the first American, and largest-ever randomized trial of the issue and its results should     help surgeons and patients make more informed healthcare decisions.   "
37021|NCT02801123|"     Background: As more people survive cancer, the importance of research on effective     interventions for improving quality of life (QOL) amongst survivors is growing. Two     interventions with a substantial evidence-base are Mindfulness-Based Cancer Recovery (MBCR)     and Tai chi/Qigong (TCQ). However, these interventions have never been directly compared.      Objectives: (1) To compare MBCR and TCQ to each other and a waitlist control condition using     an innovative, randomized, preference-based comparative effectiveness trial (CET) design that     takes into account potential moderating factors that might predict differential response. (2)     To investigate the impacts of MBCR and TCQ on a range of biological outcomes including immune     processes, blood pressure, heart rate variability, stress hormones, cellular aging, and gene     expression.      Methods: The study design is a preference-based multi-site randomized CET incorporating two     Canadian sites (Calgary, AB and Toronto, ON). Participants (N total = 600). Participants with     a preference for either MBCR or TCQ will get their preferred intervention; while those     without a preference will be randomized into either of the two interventions. Within the     preference and non-preference groups, participants will also be randomized into immediate     intervention groups or a wait-list control. Outcome measures to be assessed pre- and     post-intervention and at 6-month follow up include psychological outcomes (mood, stress,     mindfulness, spirituality, post-traumatic growth), QOL, symptoms (fatigue, sleep), physical     function (strength, endurance), and exploratory analyses of biomarkers (cortisol slopes,     cytokines, blood pressure/heart rate variability, telomere length, gene expression), and     health economic measures.      Hypotheses: The investigators theorize that both MBCR and TCQ will improve outcomes amongst     survivors relative to treatment as usual, particularly if patients have a strong preference     for a particular intervention. Specifically, the investigators hypothesize that MBCR may be     superior to TCQ on measures related to stress and mood. Conversely, TCQ may be superior to     MBCR in improvement of physical and functional measures.   "
37022|NCT02801110|"     Parkinson's disease (PD) is a chronic, progressive, neurodegenerative disease that affects 1%     of the population older than 60 years. The disease presents as a movement disorder     manifesting mainly with resting tremor, bradykinesia, cogwheel rigidity and postural     instability along with cognitive and behavioral disturbances and symptoms of other non-motor     systems dysfunction. The pathophysiology of the motor dysfunction in PD is related to gradual     loss of nigrostriatal dopaminergic neurons (originating from the substantia nigra (SN)     compacta to the striatum) leading eventually to depletion of dopamine in the striatum.      Striatal fluorine-18 isotopologue for L-3,4-dihydroxyphenylalanine([18F] F-DOPA) uptake     follows a typical spatiotemporal pattern along the course of disease starting with a     decreased uptake in the dorso-caudal putamen (contralateral to the side of predominant motor     involvement) that progress to the caudate nucleus.      The role of traditional magnetic resonance imaging (MRI) in the evaluation of PD is aimed     mainly to differentiate idiopathic PD from secondary parkinsonism (e.g. vascular) and from     other degenerative but atypical parkinsonian syndromes (e.g.Progressive supranuclear palsy (     PSP), Multiple system atrophy (MSA) etc.) that are associated with distinct structural     features and therefore help establishing the diagnosis. However, new MR sequences such as     diffuse tensor imaging (DTI) and susceptibility-weighted imaging (SWI) are now being     investigated to evaluate the nigrostriatal dopaminergic neurons and iron accumulation in the     SN, respectively.      Resting-state functional magnetic resonance imaging (fMRI) that depicts brain network     organization has been shown to be altered in patients with PD. In this technique, temporally     synchronous, spatially distributed, spontaneous low frequency blood-oxygen level-dependent     signal fluctuations in task-free settings are further clustered into maps of functional     large-scale neural networks. Lower network efficiency that worsens as disease progresses has     been shown in patients with PD.      Recently, it has been shown that the integration of MRI and PET is technically feasible. The     investigators believe that PET/MRI offers true multimodality imaging by combining anatomy,     function and molecular processes that will allow more accurate identification of disease     progression.      To the best of our knowledge, this will be the first study to evaluate idiopathic PD (IPD)     with 18F FDOPA PET/MRI.      The aim of the study is to assess the feasibility of the modality and to evaluate both     visually and quantitatively the association between the dopamine metabolism measured in the     striatum by 18F-FDOPA PET with structural and functional MR findings in patients diagnosed     with IPD with asymmetrical motor signs.   "
37023|NCT02801097|"     This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical     activity of RRx-001 administered in combination with irinotecan.      RRx-001 is associated with resensitization to irinotecan in tumors that are previously     refractory. This effect has been attributed to the ability of RRx-001 to restore the     expression of aberrantly silenced genes, thus re-establishing pathway functions. However,     resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular     modulation, leading to improved penetration of standard chemotherapy.   "
37024|NCT02801084|"     The study proposed in this protocol aims to document the physiological, subjective,     behavioral, and neural effects of reduced environmental stimulation (floating) in patients     with current or prior anorexia nervosa The primary aim of this study is to determine the     safety of this intervention. Secondary aims including determining whether floating has an     impact on symptom reports such as those related to anxiety and eating disorders.   "
37025|NCT02801071|"     The purpose of the study is to show that the intake of L-citrulline improves muscle function     in patients with Post-Polio Syndrome.   "
37026|NCT02801058|"     A wide number of osteopathic techniques focusing on diaphragm have been proposed but,     although systematically and efficiently used, there is a general lack of evidences able to     clarify how and to which extent osteopathic manipulative treatment (OMT) on diaphragm is     effective and determines a modification in muscles contractility and motion as well as an     objective determination of the benefit on the patients receiving treatment.      This study therefore aims at investigating whether, and how, a single session of selected     osteopathic diaphragmatic techniques are able to affect muscle motility and thickness,     assessed by ultrasounds, in a sample of healthy subjects and to compare results versus a     group receiving a sham therapy and another one of non-treated subjects.   "
37027|NCT02801045|"     This study evaluates from the patient's perspective which elements of the own artistic     creative process are the source of a beneficial change for him/her and how those elements     influence in their end of life experience.   "
37028|NCT02801032|"     In a double blind placebo-controlled cross-over study the effect of tadalafil on blood flow     velocity in the large arteries of the brain, cortical brain oxygenation, peripheral     endothelial function, and endothelial biomarkers will be tested in patients with lacunar     stroke caused by cerebral small vessel disease.   "
37029|NCT02801019|"     Vitamin E incorporated highly cross linked polyethylene (E-XLPE) was developed to increase     oxidative resistance of highly cross-linked polyethylene (XLPE) without affecting mechanical     properties. The investigators evaluated this type of polyethylene in a randomized clinical     study, using Radiostereometric Analysis (RSA). The objective of this study was to compare the     early-term wear of E-XLPE to a compression annealed polyethylene liner (C-XLPE, ArComXL®).     The clinical outcome at two years was not expected to be affected by the choice of     polyethylene.   "
37046|NCT02800772|"     Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic     ductal cells. In this study, acetic acid spraying to duodenal bulb was compared with saline     solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome     was successful deep pancreatic duct cannulation. The secondary outcomes were the appearance     of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to     achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct     cannulation in the acetic acid group versus saline group.   "
37030|NCT02800980|"     Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic     lymphadenectomy performed for treatment or staging purposes in the management of some     cancers. Management procedures are: single or repeated puncture, prolonged drainage with     drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which     management option is most optimal, should be guided by two principles: first to control     patient's symptoms, second to apply the least invasive but effective way to treat LC, taking     into account that the patient has undergone major surgery recently, and often needs adjuvant     treatment at the moment when symptomatic LC is diagnosed.      The aim of this study is to validate feasibility, safety and efficacy of a minimally invasive     management of a symptomatic LC - drainage with the usage of vascular catheter followed by     sclerotherapy, as well as to evaluate patient's experience on the treatment.      Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated     volume of LC and other organs failure if appear is recorded. Management options are discussed     with patient, and if the method with catheter insertion and drainage is chosen than the     patient is eligible for the study. After vascular catheter insertion into LC and fluid     evacuation, patient is followed with active drainage. Patients with drainage only are     observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is     considered. In case a patient does not agree to sclerotherapy, or there are     contraindications, or it is doctor's decision that drainage alone is sufficient, than the     prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen     used for sclerotherapy, it's volume, time intervals between repeated infusion depend on     institution practice.      Data concerning feasibility, safety and efficacy are noted in designated templates. Patients'     experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.      The study is observational. Primary outcome measure is to establish efficacy of the method.     Secondary outcome measures are safety and patient's experience on the treatment.      Investigators hope to establish step-by-step guidelines for optimal, minimally invasive     management of symptomatic lymphocele.   "
37031|NCT02800967|"     The existing scientific evidence from both in vitro and clinical trials supports the notion     that polyphenols can modulate platelet function. Beyond being central players in haemostasis     and thrombosis, platelets have crucial roles in the development of atherosclerosis, mediated     through their interactions with monocytes and endothelial cells. Disturbed platelet function     correlates with other risk factors, including hypertension and obesity, and the progression     of cardiovascular diseases (CVD), postulating platelets as rational targets in CVD     prevention. Thus, the effects of polyphenols on disturbed platelet function would contribute     to their pleiotropic beneficial effects of on cardiovascular health. Aronia juice is a rich     source of polyphenols including anthocyanins, procyanidins, phenolic acids and flavonols.     However, there is no clinical evidence on the effects of aronia juice consumption on platelet     function and related CVD factors. The purpose of this study is to investigate the effects of     Aronia juice polyphenols on platelet function and other CVD risk factors in subjects with     moderate CVD risk.   "
37032|NCT02800954|"     The Primary objective of this study is to compare serum levels of Macrophage-Colony     Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a     population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in     a control population.   "
37033|NCT02800941|"     Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the     indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension     (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their     low level of proof in the PHT. Last but not least, anticoagulants are known to be the     principal cause of iatrogenic hospitalization (major bleeding).      In this study, patients are all followed during one year, to determine the annual frequency     of major bleedings (according to the International Society on Thrombosis and Haemostasis     (ISTH) international definition). Each event notified is validated by an independent     committee for clinical events.   "
37034|NCT02800928|"     A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human     Laboratory Model of Stress-precipitated Smoking Behavior.   "
37035|NCT02800915|"     The goal of the project is to study whether interdisciplinary follow- up performed via     telemedicine to the patient in his or her own home, will improve the quality of the     healthcare services offered to a particular group of patients. The investigators believe this     could increase knowledge and expertise, give significant socioeconomic benefits, and allow     greater accessibility to specialized healthcare services, as well as increase the     user-involvement for patients and those working in primary healthcare.   "
37036|NCT02800902|"     Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the     body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a     rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV)     have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to     explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery     system as an adjunct to scaling and root planing (SRP) for the treatment of degree II     furcation defects.   "
37037|NCT02800889|"     This is a phase 1, open-label, dose escalation study to evaluate the safety,     pharmacokinetics, and antitumor activity of pixantrone in pediatric patients with relapsed or     refractory solid tumors (excluding those with CNS tumors) or lymphoma.   "
37038|NCT02800876|"     Retrospective study to evaluate the impact of computational wall stress analysis based on     computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional     predictor for rupture with dedicated software.   "
37039|NCT02800863|"     The purpose of this prospective, multicenter, single arm post-approval study is to     demonstrate continued safety of the Axium Neurostimulator System for dorsal root ganglion     (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for     permanent implants.   "
37040|NCT02800850|"     Many older adults with dementia living in long-term care facilities experience depression and     agitation, which cause angst and personal suffering. Prior to this research, evidence was     inconclusive but indicated that bright light exposure may reduce depression and agitation in     long-term care residents with dementia. The purpose of this study was to determine if the     degree of improvement in depression and agitation scores over the course of eight weeks was     significantly greater in persons with dementia receiving bright light exposure than in     persons with dementia receiving placebo light exposure. Sixty individuals participated in the     study, with 30 in the bright light group and 30 in the low level light group.   "
37041|NCT02800837|"     Prospective, non-randomized, multi-center study assessing the long term safety and efficacy     of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected     left main coronary artery disease.   "
37042|NCT02800824|"     To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and     Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects   "
37043|NCT02800811|"     First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study     evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.   "
37049|NCT02800733|"     anxiety disorder is one of the major public health problems worldwide. 25% of people     experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as     the most prevalent anxiety disorder. Saffron has previously approved as an effective adjuvant     therapy in depression and might alleviate GAD symptoms.Since up to the best of our knowledge     no human studies have assessed the therapeutic effect of saffron as an adjuvant therapy in     GAD patients, Therefore, this study is planned to evaluateThe effect of saffron (Crocus     satious L.) in the treatment of mild to moderate generalized anxiety disorder:   "
37050|NCT02800720|"     A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation     Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating     fibromyalgia syndrome.   "
37051|NCT02800707|"     This study will determine the influence of two non-caloric sweeteners on glucose metabolism     via the gut microbiome in adult men and women.   "
37052|NCT02800694|"     Labor pain is the most severe pain most women will endure in their lifetimes. The most     complete and effective method of pain relief during childbirth is neuraxial labor analgesia     which provides adequate analgesia without maternal or fetal sedation. Epidural and combined     spinal-epidural (CSE) analgesia are the standard techniques performed in the developed     countries. Having an epidural catheter in place produces flexibility with labor management.     The catheter can be dosed intermittently for parturients in whom labor is prolonged, who     require surgical manipulation for vaginal delivery, or who require cesarean section for     delivery (1). However, unavailability of full-time epidural services in low-resource     countries results in minimal or no analgesia provided to laboring parturients. The     suitability of single-shot spinal analgesia has been previously studied in advanced, rapidly     progressing labor in primiparous and multiparous women and was found that it may be a useful     alternative for painless labor in the case of limited resources for epidural analgesia     (2,3,4). However, duration of action is a limiting factor of intrathecal analgesia,     particularly for primiparous women.      A 25 μg dose of fentanyl lasts 60-90 minutes. The study investigating the dose response     relation for intrathecal fentanyl showed that the maximal analgesic effect is achieved at     about 25 μg fentanyl. Above this dose, the duration of action increases but with increasing     the incidence of side effects (5). Synergy has been noted between 25 μg of fentanyl and 2.5     mg of bupivacaine with analgesia lasting about 3 hours (6). The investigators hypothesized     that increasing the bupivacaine dose to 5 mg with 25 μg fentanyl can prolong the duration of     analgesia. So, this dosage combination can be used at an early stage in     appropriately-selected primigravida parturients. The purpose of this study is to investigate     the safety and effectiveness of single-dose spinal analgesia to control labor pain in     properly-selected primiparous women in a tertiary referral maternity hospital   "
37053|NCT02800681|"     The purpose of this study is to identify psychopathology (psychiatric symptoms) that can     differentiate between Schizotypal Disorder (SD) and Asperger Syndrome (normal IQ, no language     impairment Autism Spectrum Disorder) (AS) in young adults.      With our present knowledge, the differentiation between AS and SD can be difficult, as they     both present with social difficulties, odd (but not psychotic) behaviour, and a 'feeling of     not being as everyone else'. Studies suggest that adults with AS symptoms are either     overlooked, or diagnosed within the schizophrenia spectrum in Adult Psychiatry.      A 'correct' diagnosis is important, as it is the first step towards the most optimal plan,     treatment and rehabilitation for the patient. The only way to diagnose psychiatric illness is     the description of present psychopathology.      To identify symptoms that can differentiate between the two disorders, we will use     semi-structured interviews to explore present psychopathology in young adults with typical     symptoms of SD and AS respectively, with special focus on presence of alterations in     self-experience. Alterations in self-experience are typical for the schizophrenia spectrum,     and are therefore not thought to be equally present in AS and SD.      The hypotheses are that the total level of altered experiences is higher in SD, than in AS,     and with a different pattern of altered experiences in SD than in AS. If the hypotheses are     true, an examination of altered self-experience will be valuable to aid clinical     differentiation between the two disorders.   "
37054|NCT02800668|"     Implantation of a duodenal-jejunal endoluminal bypass liner (DJBL) has shown to induce weight     loss and to improve metabolic parameters. DJBL is a reversible endoduodenal sleeve mimicking     biliodigestive digestion while lacking risks and limitations of bariatric surgery.      Effects on metabolic control, body mass parameters, appetite regulation, glucose tolerance,     organ health, and lipid profile were determined in 16 morbidly overweight patients with type     2 diabetes mellitus. In addition, relevant hormones (Leptin, ghrelin, gastric inhibitory     peptide, glucagon-like peptide 1, and insulin) were measured by enzyme-linked immunosorbent     assay (ELISA) and chemiluminescent microparticle immunoassay (CMIA) at 0, 1 and 32, and 52     weeks post-implant following a mixed meal tolerance test, which was applied for diagnostic     purposes only.   "
37055|NCT02800655|"     This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin),     which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect     information about patients taking their ARV medications. The wearable sensor records     information, which is uploaded wirelessly to a mobile device and then to a secure computer.     Together the sensors and the mobile device transmitting the information to the study computer     are called a digital health feedback system (DHFS), which gives healthcare providers     information about when patients have taken their ARV medications.      The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to the     HIV patient population; that patients will persist with its use; and that the system provides     valid, accurate measures of adherence.   "
37056|NCT02800642|"     Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood     away from the retina (the very back portion of the eye) becomes blocked, causing the leakage     of fluid into the retina and thereby causing a swelling of the macula (the portion of the     retina responsible for fine vision). This swelling is called macular edema. When the macula     swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown     to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and     in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the     treatment of macular edema secondary to CRVO in the United States (US), European Union (EU),     Japan, and other countries.      The study is considered research because, although the study drug is already on the market     for macular edema secondary to CRVO, there are no studies available that address the     questions of what are useful intervals for treating and assessing patients, how do they     differ among patients, and how are criteria applied for retreatment. The purpose of this     study is to evaluate the effectiveness, treatment interval, and safety of the treatment     regimen (pattern for administering treatment) in subjects with macular edema secondary to     CRVO. In addition, this study will explore new imaging methods for assessing the affected     eye.   "
37057|NCT02800629|"     The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3     inhibition with MCP to placebo for the treatment of knee osteoarthritis.   "
37058|NCT02800616|"     Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles     often persist from generation to generation and contribute to a vicious cycle of     health-related and social problems. We present a study protocol that examines the     effectiveness of two novel, integrated healthy school interventions. One is a full     intervention called 'The Healthy Primary School of the Future', the other is a partial     intervention called 'The Physical Activity School'. These intervention approaches will be     compared with the regular school approach that is currently common practice in the     Netherlands. The main outcome measure will be changes in children's body mass index (BMI). In     addition, lifestyle behaviours, academic achievement, child well-being, socio-economic     differences, and societal costs will be examined.   "
37059|NCT02800603|"     The purpose of the study is to evaluate the first Canadian implementation project of the     Family Check up (FCU), an evidence-based prevention and early intervention model that engages     families and communities in reducing the burden of childhood emotional and behaviour problems     (EBP).   "
37060|NCT02800590|"     This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult     participants undergoing elective colonoscopy for screening or diagnostic purposes. This study     is designed to test various ABP-700 infusion regimens for rational selection of one or more     dosage regimen(s) to be used for future clinical development of ABP-700 in procedural     sedation.   "
37061|NCT02800577|"     In England over 800,000 patients each year are either newly diagnosed with depression or     present with a new episode of depression in primary care. The majority of patients do not     respond to the first drug prescribed and have to try several different antidepressants before     an effective treatment is found. Antidepressants have a slow clinical onset of action, taking     4 to 6 weeks before changes in mood become apparent. No test exists to guide General     Practitioners (GPs) as to whether their patient is responding to the prescribed successive     treatments. This often results in delays of many months before patients return to good mental     health. The GP-ETB is a set of computer-based emotional processing tasks. It was developed     and optimised to be sensitive to early changes in emotional bias that are indicative of     successful antidepressant treatment. The current investigation is an exploratory study using     the GP-ETB.      It will test the predictive ability of the GP-ETB with regard to later subjective drug     response and nonresponse. The study will recruit depressed patients from primary care     settings. There are no study drugs prescribed as part of this clinical investigation.     Eligible patients will have been prescribed citalopram by their GP prior to study entry. The     decision to initiate treatment with citalopram will be independent of study participation.     The duration of the study is 5 months. Each patient will be required to attend 3 visits and     total duration of the study for the patient will be 46 weeks. During the visits patients will     be asked to complete a variety of questionnaires and GP-ETB tasks on the computer.     Sensitivity and specificity data collected during this study will be used to develop a     computer algorithm intended to predict response at 46 weeks, based on GP-ETB data collected 1     week after initiation of antidepressant treatment.   "
37062|NCT02800564|"     Optimal infant and young child feeding practices are largely inadequate in rural and poor     households in Ghana. Child welfare clinics (CWCs) focus on immunization, supplementation, and     growth monitoring and promotion (GMP) activities among infants and young children (IYC). An     essential component of GMP activities is to counsel mothers to practice optimal IYC feeding     and health practices, but most of the time this is completely missing or not specific enough     to be effective.      This study will test the effect of a mass media nutrition education program on caregiver     infant and young child feeding knowledge, attitudes and practices using a community-based     cluster randomized design. Formative research will first be undertaken to determine the     beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their     infants and young children with members of the community (caregivers with children     under-five, men and elderly women).The information gathered will then be used to design     specific messages that directly address the IYC feeding challenges of the community. Clusters     will be randomized into active (radio messages with in-person engagement and follow-up) and     passive (only radio messages) arms of the intervention. Farm Radio International     (implementers of the mass media programming) will ensure the regular broadcast of twice     weekly messages for a period of about 12-18 months.   "
37063|NCT02800551|"     This study will compare pain (primary end-point) and local metastatic tumor control     (secondary end-point) after dose-intensified image-guided fractionated stereotactic body     radiation therapy (SBRT) for painful mass-type spinal metastases versus conventional     radiation therapy.   "
37064|NCT02800538|"     The previous research by one of our members in the research team (H. Miller) suggests a     possible influence of oral nutrients intake of certain fat or carbohydrates (glucose,     fructose) on executive control. On the other hand, another previous study from our group (L.     Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids     on subjective and neural responses to negative emotion induction. The purpose of this study     therefore is to examine the effect of intragastric administration of certain fatty acids and     carbohydrates on executive control in healthy volunteers.      Therefore two group of healthy volunteers are invited to the study. The first group will be     randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube     in each of the visits， while the second group receives one of two carbohydrates or saline in     a random order. After the exposure period, participants will use a computer to perform there     different tasks to measure executive control. During each study visit, regular measurements     of emotion, physical sensations, as well as blood glucose will be assessed. Furthermore, an     electrocardiogram will be continuously recorded for the calculation of vagal function.   "
37065|NCT02800525|"     The objective of this study is to evaluate the efficacy and safety of picosecond 532 and     1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched     532 and 1,064 nanometers laser.   "
37066|NCT02800512|"     The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment     of pelvic organ prolapse.   "
37067|NCT02800499|"     The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective,     non-interventional and observational study within the Korean COPD patients. The prevalence of     early COPD (mild to moderate COPD based by 2011 GOLD(the Global Initiative for Chronic     Obstructive Lung Disease) guideline) is high in Korea. However, the patients with early COPD     are not underdiagnosed due to mild symptom. The purpose of this study is to investigate early     COPD characteristics and disease course and to form a guideline for early detection of COPD     patients and prevention of progression to severe COPD.   "
37128|NCT02799693|"     This is a single-arm non-randomized prospective observational cohort study to assess the     outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular     tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF)     catheter ablation. Following ablation, patients will be monitored for 6 months. The duration     of the study is up to 4 years.   "
37068|NCT02800486|"     Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy,     either individually or in combination. Present therapies are inadequate, as evidenced by the     low 5-year survival rate for brain cancer patients, with median survival at approximately 12     months. Glioma is the most common form of primary brain cancer, afflicting approximately     7,000 patients in the United States each year. These highly malignant cancers remain a     significant unmet clinical need in oncology. GBM often has a high expression of EFGR     (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods     of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and     tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring     GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of     250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and     prevent tumor progression in patients with recurrent, residual GBM.   "
37069|NCT02800473|"     This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of     the inner bladder using white light and blue light excitations and (ii) high resolution     panoramic images of the bladder inner wall.      All participants will undergo fluorescence cystoscopy: the first half using first a reference     medical device for fluorescence cystoscopy already on the market then using the innovative     device specifically developped for the CyPaM2 project.      The other half will undergo fluorescence cystoscopy using first the innovative then the     reference medical device.   "
37070|NCT02800460|"     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a validated procedure, used     in many French and international centers for the treatment of severe forms of Parkinson's     disease (PD). The improvement of parkinsonian motor symptoms by stimulation of the STN is 50     to 80% on average. The main advantage of DBS is that the surgery has low morbidity and     mortality, it is adaptable to the patient's symptoms and its effect is reversible. This     treatment is now a routine and more than 85,000 patients worldwide have benefited from the     installation of this system. Since 1997, this treatment is available to patients followed in     the Pitié Salpêtrière (GHPS).      The accuracy of preoperative anatomic targeting in stereotactic neurosurgery will improve     with the use of high-field MRI. However, several new issues and inherent in that high-field     MRI should be evaluated before the images can be used directly.      The chosen sequences must be short to be feasible, minimizing patient discomfort, and     evaluated on several patients to ensure the low interindividual variability. In addition, the     quality of the display on all of the sections should provide a reliable three-dimensional     information. Finally, the quality of targeting and its possible improvement should be     checked.   "
37071|NCT02800447|"     1. To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD          regimens for patients with advanced Hodgkin's lymphoma.        2. To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma   "
37072|NCT02800434|"     The double amputation of the forearms is a rare handicap that seriously impacts the autonomy     and the quality of life of patients, social and familial exclusion, and dependence on third     parties for everyday activities.      The management of these patients is nearly exclusively through the use of prostheses. Certain     patients refuse this solution, or remain penalized by the absence of sensation, the lack of     precision in movements, and body image issues related to the amputation; the double graft of     hands and forearms may, in this circumstance, be the only solution.      The objective of this pilot study was designed to evaluate the cerebral plasticity of     patients who undergo bilateral hand allograph   "
37073|NCT02800421|"     Besides contrast-induced acute kidney injury (CI-AKI), adscititious vital organ damage such     as hypoxic liver injury (HLI) may affect the survival in patients with ST-elevation     myocardial infarction (STEMI). Therefore, the investigator sought to evaluate the prognostic     impact of CI-AKI and HLI in STEMI patients who underwent primary percutaneous coronary     intervention (PCI).   "
37074|NCT02800408|"     The purpose of this study is to determine how well the body absorbs the carotenoid     beta-cryptoxanthin (BCX) from a type of corn that has been naturally bred (not genetically     engineered) to contain higher amounts of BCX than traditional breeds of corn. Because this     new type of corn contains higher amounts of BCX, it appears more orange in color than     traditional types of corn. Understanding how well the body can absorb the BCX from the corn     may help companies develop food products that may have improved nutritional quality.   "
37075|NCT02800395|"     According to several reports, the oxidative stress and the nutrition could have an impact in     the Alzheimer disease.      The association of these two parameters measurements and the cognitive impairment decline     could help in a predictive diagnosis of cognitive decline evolution in patients presenting     cognitive disorders.      This is a monocentric prospective routine care clinical trial on patients showing cognitive     troubles especially memory complaints.      The objective is to demonstrate a correlation between oxydative stress and nutrition     biomarkers and the clinical evolution of patients complaining of cognitive impairments.      The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock     test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making     test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of     MRI contraindication) will be realized during the study inclusion phase in the usual intake     of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will     be taken at the study inclusion day during the stay at the Day hospital dedicated to the     routine intake of patients issued from the memory consultation.      In this study, the principal evaluation criteria will be the MMSE score evolution during the     60 months of the patients follow-up, measured during the routine visits scheduled     approximately every 6 months, according to the french national authority for health     recommendations. It will allow evaluating the correlation between the cognitive decline     evolution measured by MMSE during the Alzheimer disease or related diseases method during the     2 years follow-up, and the oxydative stress blood markers.   "
37076|NCT02800382|"     Lipid per oxidation final products and free oxygen radicals are thought as initiator role for     developing of cancer in the body. Level of paraoxonase in the patients with cancer varies. In     this research, the investigators investigated the contribution of level of serum and     bronchoalveolar lavage paraoxonase in the differentiation of benign and malignant lung     disease patients. This research includes the patients that are diagnosis of lung cancer     (research group) and benign pulmonary disease (control group) participated by accepted     fiberoptic bronchoscopy (FOB).   "
37077|NCT02800369|"     This research study is being carried out to study a new way to possibly treat human cervical     intraepithelial neoplasia (CIN) without invasion.      Persistent infection with specific types of human papillomavirus (HPV, most frequently types     16 and 18) may lead to precancerous lesions(CIN). If untreated, these lesions may progress to     cervical cancer within many years. In the infected cells, HPV expresses the oncoproteins E6     and E7, both of which play key roles in maintaining viral infection and promoting     carcinogenesis. Previous studies has demonstrated that E7 alone, but not E6, is sufficient to     immortalize human keratinocytes in vitro and induce high-grade cervical dysplasia in a     transgenic mouse model. These data indicated that E7 may dominate the malignant progress in     HPV-infected cells.      The agents zinc finger nucleases (ZFNs), called ZFN-603 and ZFN-758, which can cleave the     HPV16 and HPV18 E7 oncogene specifically. ZFN-mediated disruption of HPV16 and HPV18 E7 DNA     directly decreased the expression of E7, induced type-specific apoptosis in HPV16- and     HPV18-positive cells, and inhibited cell growth.      The purpose of this study is to determine whether ZFN-603 and ZFN-758 are effective in the     treatment of HPV16- and HPV18-positive cervical intraepithelial neoplasia.   "
37078|NCT02800356|"     To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in     patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to     Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in     best-corrected visual acuity, atrophy progression and safety.   "
37079|NCT02800343|"     Metabolic acidosis is a common complication that patients experience in the early     postoperative period following cardiac surgery. Increasingly, the composition and volume of     intravenous fluids administered during surgery have been implicated in the development of     postoperative acidosis. Intraoperative Cell Salvage (ICS), an autologous blood transfusion     technique employed by Cardiac/Perfusion Units to minimize blood loss during surgery, involves     the infusion of of one such fluid, 0.9% sodium chloride. The rapid infusion of large volumes     of 0.9% sodium chloride has previously been linked with the development of hyperchloraemic     acidosis. We hypothesize that the volume of mechanically salvaged of red blood cells     re-infused into patients undergoing heart surgery contributes to the acidosis that occurs in     the early postoperative period.      To test this, we have designed an observational cohort study to check for correlation between     the volume of cell salvaged blood infused during surgery and the severity of postoperative     acidosis (which will be assessed using data from routine arterial blood gas samples).   "
37080|NCT02800330|"     Regorafenib is a novel oral multi-kinase inhibitor which targets angiogenic, stromal and     oncogenic receptor tyrosine kinases. It is currently registered for GIST and mCRC. When     regorafenib is co-administered with an acid suppressive agent, the intra-gastric pH     increases, and as a result the equilibrium of ionized/non-ionized regorafenib may shift to     the less soluble non-ionized form which reduces regorafenib bioavailability and exposure.     Since proton pump inhibitors (PPIs) are often used during regorafenib therapy, this drug-drug     interaction (DDI) confronts pharmacists and oncologists with challenges in clinical practice.     In this study the investigators will therefore evaluate the impact of PPI-induced     intra-gastric pH elevation on regorafenib pharmacokinetics in patients with GIST and mCRC.   "
37081|NCT02800317|"     Chemotherapy in clinically node positive breast cancer patients is increasingly administrated     in a neoadjuvant setting. The standard treatment regimen in these cases is then: neoadjuvant     chemotherapy (NAC) followed by breast surgery and an axillary lymph node dissection (ALND).     NAC results in axillary pathologic complete response (pCR) in 1 out of 3 patients, indicating     a complete absence of axillary metastases after completion of NAC. In such events, ALND can     be regarded as overtreatment that creates unnecessary morbidity. Less invasive axillary     surgery which can accurately assess axillary pCR is therefore preferred over standard ALND in     all patients. In case of detection of remaining axillary lymph node metastases by this less     invasive axillary surgical procedure, completion axillary treatment is standard of care.      The novel RISAS procedure is introduced as a possible less invasive axillary staging     procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in     axillary node positive breast cancer combined with a Sentinel node procedure. The iodine seed     in the axillary lymph node metastasis will be placed prior to start of NAC.   "
37082|NCT02800304|"     M2E is a developmental evaluation of the implementation of the Integrated Nutrition Pathway     for Acute Care, in five medical units in five hospitals in Canada.   "
37083|NCT02800291|"     M3 is a multi-site cross sectional study. Data were collected form 640 residents in 32 homes     in Canada. The primary purpose of this study was to identify food intake in residents and     compare this to recommendations, as well as determine influential determinants of food     intake.   "
37084|NCT02800278|"     Usually, cervical spine fractures are not considered as osteoporotic fractures. However,     recent studies show that odontoid fractures are the most common fractures of the cervical     spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this     observationnal study is :        -  to describe the different type of odontoid fracture and to characterize bone status in          elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma          energy.        -  To describe short and long term outcomes   "
37085|NCT02800265|"     Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout     extracts in tablet form, hypothesized to activate protective cellular pathways including     detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to     evaluate both bioavailability and its bioactivity in cheek cells.   "
37086|NCT02800252|"     Therefore, the aim of this study is to investigate the effectiveness of daily supplementation     of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage     full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in     type 2 diabetic patients through a superiority randomized clinical trial.   "
37129|NCT02799680|"     The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of     differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33)     infusions in patients with relapsed / refractory acute myeloid leukemia (AML).   "
37130|NCT02799667|"     The investigators aim to show that single use negative pressure dressings can decrease the     rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at a     tertiary medical center by randomizing women to receive either a single use negative pressure     dressing or the standard dressing after cesarean delivery.   "
37087|NCT02800239|"     Protein requirements in active individuals have been suggested to be greater than the current     recommended dietary allowance (RDA).      Nutritional requirements for dietary amino acids in adolescents have traditionally been     determined utilizing the nitrogen balance technique, which is prone to underestimating     protein requirements. As a result, there is a need to re-evaluate recommendations in order to     characterize how dietary amino acid needs may be modulated by physical activity.      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique     have suggested that protein requirements in young men are at least 50% higher than the RDA     based on nitrogen balance data.      The purpose of this study is to measure the protein requirement in adolescent, females using     the IAAO technique in the presence of a variable intensity exercise stimulus.   "
37088|NCT02800226|"     This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore     potential biomarkers of treatment response   "
37089|NCT02800213|"     Investigators compared tidal volumes for single rescuer ventilation using a modified bag     valve mask with a supplemental external handle versus a conventional bag valve mask in a     manikin model.   "
37090|NCT02800200|"     The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and     potential treatment for patients with kinds of musculoskeletal disorders. Although few     clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral     neuropathy, the effect of combined PRP and ESWT is absent so far.   "
37091|NCT02800187|"     The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.     The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy     on carpal tunnel syndrome.   "
37092|NCT02800174|"     To validate the long-term effects of implantation of the self-expanding Smart nitinol stent     system for the treatment of severe atherosclerotic carotid stenosis in a 2-year follow-up     study of a large patient cohort   "
37093|NCT02800161|"     The ongoing research on bipolar disorder (BD) has highlighted its pervasive and debilitating     nature, characterized by lifelong recurrent episodes and residual intraepisodic     symptomatology. Epidemiologic, comorbidity, cost-of illness, and mortality studies have     reported dramatic illness-associated morbidity and premature mortality in bipolar patients.     The efficacy and safety of antidepressant drug treatment in BD is the subject of     long-standing debate based on a scientific literature that is limited and inconsistent. The     evidence base for the use of antidepressant drugs in BD is strikingly weak, and there is     insufficient evidence for treatment benefits with antidepressants combined with mood     stabilizers. The need to develop new agents for the treatment of depression, and in     particular bipolar depression, with better efficacy and/or tolerability, remains unmet. In     the past years there has been increasing interest in the health benefits of supplemental     and/or dietary substances in the treatment and prevention of depression. The disaccharide     trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation.     In vivo studies with trehalose show cellular and behavioural beneficial effects in animal     models of neurodegenerative diseases. Moreover, trehalose was shown to enhance autophagy, a     process that had been recently suggested to be involved in the therapeutic action of     antidepressant and mood-stabilizing drugs. In fact, trehalose may have antidepressant-like     properties and that the trehalose induced behavioral changes are possibly related to     trehalose effects to enhance autophagy. Furthermore, preliminary data indicates that     trehalose also augments lithium effects in animal models (mice). Based on this hypothesis,     this project aims to conduct a study to assess the efficacy and tolerability of trehalose as     adjunctive treatment to lithium in bipolar depression.   "
37094|NCT02800148|"     To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the     treatment of Inflammatory Lesions of Rosacea   "
37095|NCT02800135|"     Acute kidney injury (AKI) is a common disorder and associated with high morbidity and     mortality. However, distinguishing transient AKI from persistent AKI may help in     individualizing treatment and limit short and long term consequences of AKI. Previous studies     suggested usual urinary indices to perform poorly for separating transient from persistent     AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease     Improving Global Outcomes) guidelines underlined the need for additional strategies in     estimating renal short term prognosis.      Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically     ill patients. This stress test performance was found to be good in predicting capacity to     identify those patients that will progress to advanced stage AKI. Additionally, FST     performance was higher than those of usual renal biomarker. The limited sample size of this     preliminary study however precluded adjustment for usual confounders including oliguria.      The primary objective of this study is to assess diagnostic performance of FST in     differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic     performance of FST in predicting need for renal replacement therapy, and to confirm FST     results after adjustment for confounders.   "
37096|NCT02800122|"     This is an observational retrospective single-center study (CHRU of Nancy) in patients cared     for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy.      The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea     by a medical team of emergencies of CHRU of Nancy.   "
37097|NCT02800109|"     The purpose of this study is to measure the impact of maternal malaria on child growth in the     two first years of life in relation to fetal growth.      This study is following a birth cohort of children born to pregnant women enrolled in the     study Impact of malaria infection in pregnancy on fetal and newborn growth (protocol OXTREC     14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2 years     of age using routine anthropometric measurements such as weight, length, arm and head     circumference. A few additional tests will enhance the sensitivity of the study outcomes with     minimal risk. These tests will include anthropometry, screening, nutrition questionnaire and     neurodevelopmental assessment.   "
37098|NCT02800096|"     Comorbidity between problem gambling and mental health concerns such as anxiety and     depression is common. Further, the treatment needs of people with co-occurring gambling and     mental health concerns may be different from those of problem gamblers who do not have a     co-occurring mental health concern. The present study is a two-arm, double blinded, parallel     group randomized controlled trial (RCT) that will evaluate whether there is a benefit to     providing access to mental health Internet interventions (G+MH intervention) in addition to     an Internet intervention for problem gambling (G-only intervention) in participants with     gambling problems who do or do not have co-occurring mental health concerns.   "
37131|NCT02799654|"     In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and     radiological results of the cementless Excia T® prosthesis in routine clinical use shall be     assessed and the migration taking place in the first 24 months evaluated.   "
37099|NCT02800083|"     -  The study primary end point is the decrease in the number of monthly heavy drinking days          (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the double          blind Randomized Treatment (RT).        -  The Secondary end points will be designed to assess safety and tolerability and to          further investigate the effect of pitolisant on other alcohol use criteria (e.g. total          alcohol consumption, number of abstinence days), craving as well as the improvement in          mental health (depression, sleep) and quality of life.             -  Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined               as mean daily alcohol consumption in g/day over a month (28 days).             -  Percent of patients without HDDs during the 24 weeks RT phase of the study.               (Continuous Controlled Drinking=CCD)             -  Percent of Abstinent Days during RT phase (PAD)             -  Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD)             -  4-week point prevalence abstinence at end of treatment             -  Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase             -  Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase             -  Beck Depression Inventory (BDI) during 24 week RT phase             -  Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase.             -  Treatment retention during 24 week RT             -  Quality of life (SF-12) during RT phase             -  Percent patients without HDDs during the OL follow up period             -  Quality of life (SF-12) during OL phase             -  Quality of sleep (Pittsburgh Sleep Quality Index) during OL phase             -  Treatment retention OL phase Safety will be assessed by evaluation of treatment               emergent adverse events (TEAE), physical examinations, clinical laboratory tests               (blood chemistry, hematology, and urinalysis), subsequent end of treatment               potential withdrawal, evaluation scales and physical examination, measurement of               heart rate, blood pressure, and body weight at each study visit )V0-FU5). If at ECG               Fridericia's corrected QT interval ≥ 500 ms or if difference to baseline is ≥ 60 ms               it will be required to check ECG by second measurement after lying down 10 minutes.   "
37100|NCT02800070|"     This is a first-in-human study for the treatment of Fabry disease. Eligible patients will     have an autologous stem cell transplantation using CD34+ cells that are transduced with the     lentivirus vector containing the human alpha-gal A gene. The researchers of this study would     like to see if the re-introduction of transduced cells will help increase the levels of     alpha-gal A enzyme levels and to determine the safety and toxicity of autologous stem cell     transplantation using CD34+ cells transduced with lentivirus vector containing the alpha-gal     A gene. This study's objective is to determine the safety and toxicity of lentivirus     alpha-gal A transduced CD34+ cells in adult males with Fabry disease.   "
37101|NCT02800044|"     The overall goal for this pilot clinical trial is to explore the accuracy and acceptability     of a non-invasive, wearable glucose sensor in patients living with DM. This study will     compare needleless glucose sensor readings with glucometer measurements from patients with     type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.   "
37102|NCT02800031|"     To compare between the efficacy of IOTA simple rules and pattern recognition method in the     differentiating between benign and malignant adnexal masses   "
37103|NCT02800018|"     The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic     encephalopathy in term and near term neonates born in Switzerland who were admitted to the     neonatal and intensive care units offering hypothermia therapy.      Further, investigators would like to analyse the influence of these perinatal risk factors on     the severity of encephalopathy during and after hypothermia therapy.   "
37104|NCT02800005|"     As the number of obesity continues to increase, surgical oncologist pay more attention to the     effect of obesity on surgical outcomes and survival of digestive systemin cancers. Body mass     index(BMI) is one of the most widely used measurements of obesity. Abdominal fat area (AFA)     calculated by computed tomography is popular because of its validity of fat distribution.     There is still no consensus which of BMI and AFA could be the more effective measurement and     more accurate to evaluate effect of obesity on surgical outcomes and survival. Gastric cancer     is one of the most common digestive system cancers, and gastrectomy is the primary     therapeutic options.It is important to compare the different measurements(BMI or AFA) to     assess obesity and effect on surgical outcome and survival for gastric cancer patients.   "
37105|NCT02799992|"     Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients,     characterized by serous retinal detachment in the macular region. We evaluated half-dose     verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.      Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to     receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805     mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical     coherence tomography findings were compared between groups.   "
37106|NCT02799979|"     Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival     is very poor and has been closely related to right ventricular dysfunction. Current     prognostic equations rely mostly on right heart catheterization data. The identification of     simple echocardiographic prognostic factor is urgently needed. It could help identifying with     a non invasive method, high risk patients who could benefit from an intensive specific     therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV     volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.      The aim of this study is to validate a new software for 3D analysis of the right ventricle     and assess its prognostic role in pulmonary hypertension.      To do so, the investigators will realize a prospective monocentric longitudinal cohort study,     including 100 pulmonary hypertension patients. Echocardiographic data will be collected at     baseline and after 6 months.   "
37107|NCT02799966|"     Many individuals with cervical spinal cord injury (SCI) have difficulty using their hands and     arms. MyndMove is a non-invasive medical device that uses short, low energy electrical pulses     with surface electrodes to cause muscle contractions to produce a full range of reaching and     grasping movements, which the patient is unable to perform by him/herself.      By using MyndMove therapy to help the individual move their arms and hands as he/she attempts     to carry out typical reaching and grasping movements, the individual improves their ability     to perform these tasks voluntarily.      The purpose of this study is to study the effectiveness of MyndMove therapy in improving the     ability of individuals to move their arms and hands.   "
37132|NCT02799641|"     Does the addition of cervical lidocaine injections and valium to the current practice result     in decreased reported pain with tenaculum placement, IUD insertion, and post procedural     discomfort? The current practice is ibuprofen alone or no medication.   "
37180|NCT02799017|"     Participants will receive either intensive phonology or semantic feature analysis treatment     for 16 weeks to improve naming, reading, and writing in individuals with chronic post-stroke     aphasia.   "
37191|NCT02798874|"     The 'no-reflow' phenomenon after a percutaneous coronary intervention (PCI) in patients with     acute ST-segment elevation myocardial infarction (STEMI) is a strong predictor of both short-     and long-term mortality. Faster antiplatelet activity and increased levels of adenosine     provide a theoretical basis for ticagrelor to effectively prevent no-reflow after PCI. We     planned to evaluate the effects of ticagrelor on myocardial no-reflow after PCI for STEMI.   "
37108|NCT02799953|"     Objective: To develop and evaluate a technology-augmented self-monitoring model using a     randomized controlled trial to demonstrate whether patients with co-morbid type 2 diabetes     mellitus and hypertension can improve their glycemic and blood pressure control, adherence to     medication regimens, and other relevant outcomes by using a tablet-based consumer health     information technology (CHIT) to support the self-monitoring and self-management of their     chronic conditions.      Design: A two-group, randomized controlled trial with follow-up assessments 8, 12, 16, and 24     weeks after the baseline evaluation.      Setting: Patients' homes.      Participants: Two hundred and ninety-six adult patients with type 2 diabetes mellitus and     hypertension who receive their health care from a local community health service network or a     major hospital will be recruited.      Interventions: Participants in the technology-augmented self-monitoring model (intervention     group) will use a tablet-based, interactive touch screen self-monitoring system to monitor     and manage their chronic conditions. The system is designed to augment patients' abilities to     assess, record, and review their health signs while providing text-, audio-, and video-based     resources supporting disease self-care. The participants in the usual-care group will perform     conventional self-monitoring.      Outcome measures: The primary outcomes will be glycemic control measured by changes in     HbA1c,blood pressure control assessed by changes in systolic and diastolic blood pressure,     and medication compliance. The secondary outcomes will be adherence to diabetes and     hypertension self-care activities and knowledge of diabetes and hypertension.      Implication: This study will improve our understanding of the clinical value of CHITs in     chronic disease self-monitoring and self-management.   "
37109|NCT02799940|"     The objective of the study is to determine the correlation between the physiological     variables and the degree of consolidation in lung computed tomography in patients with acute     respiratory distress syndrome   "
37110|NCT02799927|"     Objective: The study's main purpose is to evaluate and compare the clinical and radiographic     outcomes of Biodentine and a light-activated calcium hydroxide based-liner (Ultra-Blend     plus®) as indirect pulp treatment (IPT) liners, over the dentin-pulp complex of vital primary     molars with carious lesions approaching the pulp. Study design: 80 four-to-eight year-old     patients were enrolled from a Mexican University Pediatric Dentistry Clinic. A split-mouth     design trial is being conducted in order to compare both IPT interventions on 160 bilateral     primary teeth, without signs or symptoms of irreversibly inflamed or degenerative pulp     tissue. Teeth were treated and restored with a preformed crown in a single session, and then     closely followed-up for 1, 3, 6, 12, 18, and 24 months.   "
37111|NCT02799914|"     Post market clinical follow-up study about the Sinus-venous stent. Patients with venous     iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational     study will provide 1 year data about safety and efficacy.   "
37112|NCT02799901|"     Combining nivolumab with conventional multisite high dose radiotherapy seems to be an     interesting approach that could increase the antitumoral effect of nivolumab by increasing     the diversity and quantity of tumoral antigen presentation thanks to radiotherapy.     Multifractionated high dose radiotherapy (HR) targeting various tumor sites could also     increase occurrence of tumor mutations and the diversity of the T-cell receptor repertoire of     intratumoral T cells.      The purpose of this study is to combine nivolumab with 3 fractions of HR of one metastasis     for each tumor site (defined as skin/muscle, thoracic, abdomen, bone, other).      The investigators hypothesize that combining nivolumab with multisite, multifractionated HR     increases the overall survival rate at 1 year compared to published data with nivolumab     alone.   "
37113|NCT02799888|"     HLA-mismatched unrelated donor (MMUD) and HLA-haploidentical donor (Haplo Donor)     hematopoietic stem cell transplantation (HSCT) is associated with increased     graft-versus-host-disease (GVHD) and impaired survival. The chemokine receptor 5 (CCR5)     antagonist maraviroc has immunomodulatory properties potentially beneficial for GVHD control     as it can blockade lymphocyte chemotaxis without impairing T-cell function. The aim of this     study is to evaluate the safety and efficacy of maraviroc combined with standard     graft-versus-host-disease prophylaxis in patients with hematologic malignancies after     allogeneic stem cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors.     Based on the results of our previously small sample study with maraviroc combined with     cyclosporine/tacrolimus and methotrexate for prophylaxis of GVHD, the investigators plan to     perform the clinical trail.   "
37114|NCT02799875|"     Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain     ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of     either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia     to determine if either strategy will increase the number of alive ventilator-free days in the     28 days after randomization.   "
37115|NCT02799862|"     This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and     quality of life (QoL) in patients with advanced NSCLC receiving the combination of     nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.   "
37116|NCT02799849|"     A significant weight gain and obesity are observed for most patients with narcolepsy, mainly     at the beginning of the disease and narcolepsy in young children. There is no specific study     on the population and the consequences of overweight in the lives of these long-term     patients. Narcoleptic patients gain weight significantly at the onset of their illness. It is     also known that weight gain is not related to the treatment of narcolepsy. The etiology of     obesity in narcoleptic patients is not established. Several assumptions were made (physical     activity, leptin diet, metabolism). The reason and the pathophysiology of overweight and     obesity in this population therefore remain unclear.      In this study, potential change in the total metabolism (24h) for narcoleptic children that     could explain their tendency to obesity will be assessed ?   "
37157|NCT02799316|"     Hepatitis B virus (HBV) infection is a challenging health problem. According to the World     Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV     infection worldwide.      After acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface     antigen (HBsAg) had generally been believed to signify viral elimination. However, it now     becomes clear that those subjects may have occult HBV infection which is defined as the     presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection     usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody     against HBsAg (anti-HBs), but some cases might not have these serological markers     (seronegative occult HBV infection) .   "
37117|NCT02799836|"     Amblyopia is a significant health problem, affecting up to 4% of the population in the United     States. Amblyopia, commonly known as lazy eye, is a developmental visual disorder in which     one or both eyes suffer from poor vision as a result of being disadvantaged in early life.     Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes     (exotropia), and anisometropia, or a power difference between the eyes, are the most common     causes of amblyopia. If conventional treatment, such as patching the better seeing eye, is     not initiated during the critical period of visual development, lasting visual impairment may     persist throughout life. This critical period of visual development has been thought to end     around age 10. However, recent research has demonstrated that the critical period of visual     development can be extended into adulthood. Complete light deprivation in animal models has     restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in     amblyopic eyes. The objective of this pilot study is to evaluate the impact of complete light     deprivation on visual function in a cohort of human adults with severe amblyopia from     anisometropia.   "
37118|NCT02799823|"     The purpose of this study is to evaluate the safety and performance of the HLT System in     patients with severe aortic stenosis who present at High Risk for aortic valve replacement     surgery.   "
37119|NCT02799810|"     In a prospective longitudinal cohort study we aim at investigating the extent to which     pre-transplant psychosocial levels of functioning predict the medical and psychosocial     outcomes of lung transplantation. There is evidence that e.g. persistently elevated     depressive symptoms are associated with reduced survival after lung transplantation   "
37120|NCT02799797|"     This study compares the long-axis and short-axis technique of continues adductor canal block     for total knee replacement surgery. Half participants will receive long-axis catheterization,     while the other half will receive short-axis catheterization.   "
37121|NCT02799784|"     The primary objective of this study is to assess the effect of umeclidinium/vilanterol     (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD.      This is a multicentre, randomized, open label, 2 period crossover complete block design     study.      Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a     sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram [mcg] once-daily [QD])     administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray     administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be     followed by a 3-week washout period and one-week follow-up period. The total duration of     subject participation in the study will be approximately 22 weeks.      ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a     registered trademark of Boehringer Ingelheim.   "
37122|NCT02799771|"     HYPID-2 study is an extension of HYPID study (NCT01443598) :      HYPID-2 is also an observational and prospective study of patients with interstitial lung     disease and pre capillary hypertension diagnosed by right heart sided catheterization.      It concerns only incident patients (i.e patients included within 6 months after PH diagnosis)     whereas HYPID concerned prevalent and incident cases.      The primary aim is the same than HYPID : identify prognostic factors   "
37123|NCT02799758|"     The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily     compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol     (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo®     IR 4 mg daily after long-term treatment   "
37124|NCT02799745|"     The primary purpose of this study is to compare the time to prostate cancer progression     (pathological or therapeutic progression) between patients treated with enzalutamide versus     patients undergoing active surveillance.   "
37125|NCT02799732|"     This feasibility study was developed to evaluate the proposed approaches for enrollment,     sample collection, interview and retention over a six-month vaccination period for the     clinical trial: A scientific evaluation of one and two doses of the bivalent and nonavalent     prophylactic HPV vaccines (1DT) currently under development . These aspects will be assessed     quantitatively and qualitatively by measuring the efforts needed to identify and recruit each     study participant, the participation rate for the study, and the retention rate at six     months, as well as collecting information on the acceptability of study procedures. To     supplement the assessment of the acceptability of the self-collected swab among older girls,     a parallel effort will be done at the end of this feasibility study. Combined, this     feasibility work will allow for modifications to the design, approaches and methods of the     new trial.   "
37126|NCT02799719|"     Overweight and obesity have become an increasing problem in patients on hemodialysis.     However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis     patients , using body mass index(BMI) as metric fat mass is associated inversely with death     rate. Nevertheless, it is questionable that obesity can be considered an unequivocal     protective factor in chronic diseases as increase body fat mass appears to be a potential     cause of the chronic inflammation frequently present in these patients. The consequences of     this inflammation are impaired nutritional status, accelerated atherosclerosis, and increased     mortality. In the present study, by using dual-energy X-ray absorptiometry (DEXA) and     bioimpedance spectroscopy (BIS) to evaluated the contributions of fat mass to outcomes in an     observational cohort of hemodialysis patients. Besides, we aim to assess the relationship     between body fat composition, clinical metabolic risk profiles, measures of adiposity, such     as waist circumference (WC), visceral adiposity index, waist-to-hip ratio (WHR), and     waist-to-height ratio (WHtR), markers of inflammation and adipocytokines in these maintenance     hemodialysis patients.   "
37127|NCT02799706|"     The primary objective of the trial is to assess if GnRH antagonists in combination with     external beam radiation therapy improve progression free survival (progression that can be     biological, clinical, or death) compared to GnRH agonists in combination with external beam     radiation therapy.      Secondary objectives include:        -  documentation of effect of GnRH antagonists on clinically significant cardiovascular          events in the subgroup of patients at high risk of such events at baseline;        -  documentation of side effects and quality of life, I-PSS and urinary tract infections;        -  assessment of relative treatment effect on secondary efficacy endpoints (clinical          progression, time to next line of systemic therapy, time on therapy, overall and cancer          specific survival) and on PSA at 6 months after end of RT.   "
37190|NCT02798887|"     Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane     Approach to Grafting.   "
37133|NCT02799628|"     The trust between patients and medical providers is the cornerstone to obtain success     treatment. To boost the trust can increase medical prescription compliance, enhance patient     satisfaction, and improve the effectiveness of treatment. Otherwise, mistrust between medical     providers and patients will result in ineffective treatment and excessive defensive health     care. This situation may cause medical dispute and medical resources wasting problems.      Most of treatment complete in a few times of admissions and interventions. So, how to improve     the trust between patients and doctors quickly became a more knotty problem. Several studies     found that speech (including listening, showing compassion, and take longer to explain),     reputation, clothing, offer a newer therapy were more important than age, title, and sex.      However, past researches were restricted to an unclear causal relationship. That is they     can't be determined whether good doctor-patient relationship and better trust conditions     create a longer visit time, better satisfaction, and good reputation, or vice versa. They     also unable to clarify whether the high degree of trust result in improved treatment effects,     or good relationship result from good medical outcomes.      Investigators want to design a randomized control trial by giving patients recommendation and     physical therapist introductions to enhance the trust of patients to therapists. And this     study may verify whether enhance trust between therapists and patients will lead to changes     in treatment effectiveness.   "
37134|NCT02799615|"     This multicenter study is being conducted to determine whether infliximab exposure after an     initial infusion is predictive of early clinical response in hospitalized pediatric patients     with severe steroid-refractory UC or IBD-U. This pilot and feasibility study will establish     the infrastructure, demonstrate feasibility, and collect preliminary data to support the full     study.   "
37135|NCT02799602|"     The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide     (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in     patients with metastatic hormone sensitive prostate cancer.   "
37136|NCT02799589|"     This study intends to show the efficacy of remifentanil-dexmedetomidine infusions in     combination with a caudal block for patients ages 1 year to 3 years old receiving elective     surgery to investigate alternatives to the currently used volatile anesthetics.   "
37137|NCT02799576|"     The investigators hypothesized that using the curved needle could facilitate the block     placement and provide short procedure time. Aim of the work: The investigators will compare     namely straight and curved block needle with in-plane needle insertion techniques for the     infraclavicular brachial plexus nerve block (ICNB) regarding the block performance time.   "
37138|NCT02799563|"     A 2-by-2 factorial cluster randomized controlled trial was performed to: 1) Compare the     effects of supervised (coached) versus unsupervised (no coach) administration of the DKA     simulator on trainees' knowledge of DKA management immediately after (primary outcome) using     the simulation and 3 and 6 months post-intervention (secondary outcome); 2) Determine whether     a preselected number of DKA simulator practice cases or a self-selected number     (self-regulated learning) of DKA simulator practice cases will result in superior trainee     knowledge with respect to DKA management immediately after (primary outcome) and 3 and 6     months post-intervention (secondary outcome).   "
37139|NCT02799550|"     The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of     differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19)     infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)   "
37140|NCT02799537|"     Our goal is to compare two types of advance directives forms available in English and Spanish     to determine which is more easy to use for patients.   "
37141|NCT02799524|"     The objective of this study is to evaluate the scales commonly used in geriatrics and     oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress )     , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14     questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).      The prospective observational study will be conducted in parallel on two sites ( University     Hospital Centre and François Baclesse ) after informed patient information.      It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or     haematological malignancies in the hospital to meet the mood disorder screening     questionnaires .   "
37142|NCT02799511|"     A transient ischemic attack (TIA) should be considered an emergency prevention opportunity in     order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling). Indeed,     about 20% of patients who have IC had in previous days or weeks, a TIA, which can be defined     as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage     and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are AIT.     Despite the progress achieved in the treatment in the acute phase of an IC, prevention     remains the most effective way to fight against this disease. This prevention can be put in     place before the occurrence of a first IC, or after a first IC, especially when minor as a     TIA.      However, the diagnosis of TIA remains particularly difficult and it is necessary now to     identify new tools for the diagnosis of transient ischemic attack. Our study focused on the     identification of one or more molecules (called biological markers or biomarkers) present in     the bloodstream of patients, which will serve to facilitate the differential diagnosis of     patients with TIA.   "
37143|NCT02799498|"     The purpose of the study is to compare Pharmacokinetics of liquid etanercept that is     administered to healthy subjects aged 18-55 by an auto-injector device and manual injection     (each subject received both injections).   "
37144|NCT02799485|"     This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating     patients with Kaposi sarcoma. Recombinant EphB4-HSA fusion protein may block the growth of     blood vessels that provide blood to the cancer, and may also prevent cancer cells from     growing.   "
37175|NCT02799082|"     The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with     photodynamic therapy (PDT) in patients suffering from actinic keratosis.   "
37176|NCT02799069|"     The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the     treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.   "
46113|NCT02682043|"     The purpose of this study is to investigate parental attitudes towards their child who has a     mobility impairment, to using a modified electric toy car, and to evaluate from their     perspective, if it facilitated social interaction for their child with mobility impairment.   "
37145|NCT02799472|"     This study is designed to explore the activity of granulocyte-macrophage colony stimulating     factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential     impact of inhibition of this axis by GSK3196165, and to evaluate whether there are any     differences in the GM-CSF axis between subjects with early RA compared with those with more     established disease. This study also aims to establish the potential impact of GSK3196165 on     inflammatory structural joint damage in the hand/wrist using magnetic resonance imaging     (MRI). This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled     parallel group study. Approximately 40 subjects with active RA despite treatment with     disease-modifying antirheumatic drugs (DMARDs) (including conventional or biologic) will be     randomized into the study, following a screening period of up to 6 weeks. The total treatment     period is up to 10 weeks, with a 12-week follow-up period after the last dose (Week 22).   "
37146|NCT02799459|"     Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in     Anesthesia's field.      This study wants to prove that the Hypnosis in conization are cheaper.   "
37147|NCT02799446|"     The purpose of this study is to determine whether Reslizumab is effective for the treatment     of chronic sinusitis.   "
37148|NCT02799433|"     This randomized controlled trial uses administrative public health screening data to test     whether the Healthy Apple program (HAP), designed to support local implementation of national     Let's Move! Child Care guidelines in San Francisco (SF), improves child care center nutrition     and physical activity practices and child weight change.   "
37149|NCT02799420|"     The purpose of this study is to conduct a study on genetic pathology, obtaining of pure     cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for     diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or     less. Recently, confocal laser endomicroscopy has been introduced for real-time     histopathologic diagnosis in various cancers. In previous pilot study in our institution,     pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in     biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with     undifferentiated histology. However, there was a limitation because of small sample size.     Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser     endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer     cells and expression ratio of tumor marker in biopsy samples.   "
37150|NCT02799407|"     The purpose of this study is to compare the modular, multi-tiered consent process featured in     Apple's ResearchKit (RK) to the standard consent process. The primary objective is to     determine whether participants using the ResearchKit consent form have a significantly higher     comprehension of the elements of consent than participants using the standard consent form.   "
37151|NCT02799394|"     The purpose of this study is to investigate the effect of activity modification, exercises     and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The     primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary     endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The     adolescents will be recruited from primary schools, general practitioners and through online     advertising on Facebook.   "
37152|NCT02799381|"     The primary objective of this study is to examine the effect of levodopa-carbidopa intestinal     gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with     advanced Parkinson's disease (PD).   "
37153|NCT02799368|"     As iodinate contrast media (CM) has been widely used in current medical practice, contrast     induced acute kidney injury (CI-AKI) has been an important issue.      Previously, many guidelines suggested prophylaxis protocol using 0.9% saline when CM is     administrated to high risk patients. However, recent studies showed that 0.9% saline might     induce metabolic acidosis due to its supra-physiologic chloride component, and therefore     renal vasoconstriction. In spite of protective effect by volume expansion with saline     infusion, this renal vasoconstriction might have conflicting effect on renal function, as     hypoxic injury is suspected to be the main cause of CI-AKI.      In contrast to 0.9% saline, balanced salt solution has physiologic level of chloride and     neutral pH. Also, recent studies proved preventive effect of balanced salt solution for AKI     in several clinical settings.      Hence, the investigators planned a prospective randomized controlled trial comparing 0.9%     saline and balanced salt solution to prevent CI-AKI.   "
37154|NCT02799355|"     Of the six main genotypes of the hepatitis C virus (HCV), genotypes 2 and 3 account for     approximately 30% of chronic infections worldwide. In North India, Genotypes 3 and 1 account     for 95% of chronic hepatitis C patients The first three direct-acting antiviral agents to     receive FDA approval—boceprevir, telaprevir, and simeprevir—do not currently have a role in     the treatment of genotype 3 infection. In contrast, the direct-acting antiviral agents,     daclatasvir and sofosbuvir, have good activity against all genotypes. The SVR rates of 90 -     100% in genotype 3 were achieved with oral sofosbuvir plus ribavirin regimen to 24 weeks.     Similar SVR rates were achieved in Genotype 1 with oral sofosbuvir plus weight based     ribavirin and Pegylated Interferon alpha 2 a. However, the ongoing discovery and development     of agents that directly target various stages of HCV replication are likely to provide     HCV-infected patients with effective interferon-free therapy. HCV genotype 3 infection is     associated with a higher incidence of hepatic steatosis, more rapid progression of fibrosis,     and possibly a greater risk of hepatocellular carcinoma than is HCV genotype 2     infection.Moreover, patients with HCV genotype 3 infection are less responsive to     peginterferon based treatment than are patients with HCV genotype 2 infection.   "
37155|NCT02798289|"     The primary objective of this study is to evaluate acute tear production as measured by tear     meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the     Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.   "
49156|NCT02642211|"     Prospective randomized trial in patients requiring cataract surgery in which IOP, angle     anatomy and other demographic and clinical data are compared. Subjects randomized to both     MSICS and phakoemulsification   "
37192|NCT02798861|"     The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis     using liver biopsies as reference. Secondarily, investigators will correlate transient     elastography (TE) and CAP results, analyze possible associations between CAP/TE and     post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The     study aims to include as many donors as needed to achieve 100 transplanted liver allografts.   "
37158|NCT02799303|"     In this open randomized controlled trial, we seek to study whether prostate cancer screening     using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection rate     of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate biopsy)     compared with prostate cancer screening using prostate-specific antigen (PSA).      The current paradigm of prostate cancer screening relies upon an initial PSA blood test, with     subsequent investigations driven by the serum PSA level. This model has proven highly     controversial due to the inability of PSA level to discern between indolent and aggressive     forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended     against PSA screening. Evidence suggests that prostate cancer screening has led to an     increased proportion of men being diagnosed with potentially curable prostate cancer.     However, due to the inability of the PSA level to accurately distinguish patients with     indolent and lethal forms of prostate cancer, it has led to a significant rate of     over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an     increasingly large role in the management of patients with clinically-localized prostate     cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on     active surveillance and staging prior to definitive interventions. MRI-based prostate cancer     risk assessment has been shown to better distinguish between clinically-significant and     insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based     prostate cancer screening and PSA-based prostate cancer screening is warranted.   "
37159|NCT02799290|"     Adipose Tissue Extract (ATE) has been found to be an antologous source of growth factors with     proven in vitro angiogenic and adipogenic properties.It is obtained by a simple     lipoaspiration procedure. We sought to compare the effect of ATE with another known source,     platelet-rich plasma to compare the wound healing characteristics on skin graft donor sites.   "
37160|NCT02799277|"     The main goal of this project to investigate the psychological processes underlying moral     judgments in social dilemmas. WE will examine neuroendocrine determinants of moral judgment     by investigating the effects of exogenous testosterone   "
37161|NCT02799264|"     Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1     infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen     (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food     for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase     3 treatment studies is with food regardless of fat or calorie content, when administered     along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover     study in healthy adult subjects to assess the effect of a high fat meal on the single dose     pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and     will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be     randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12     subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule     'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to     'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects     will be followed up to 30 days from the day of receiving first dose of cabotegravir to     evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.   "
37162|NCT02799251|"     Postoperative infections are one of the most common complications in thoracic and digestive     cancer surgery. Former studies have demonstrated that inflammatory response is altered during     peri-operative period causing lymphopenia. It has been suggested that lymphopenia may     contribute to postoperative infection. To date, no one has proved it in a multivariate     analysis. The aim of this study is to determine if lymphopenia is associated with     postoperative infections in thoracic and digestive cancer surgery.   "
37164|NCT02799225|"     Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora.     These micro-organisms are frequently responsible for nosocomial or community-acquired     infections, for which treatment is essentially based on the use of beta-lactam antibiotics.     This class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems.     Carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity     to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating     enzymes.      However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either     alone or in combination with additional resistance mechanisms such as loss of membrane     permeability or overexpression of efflux systems, are currently emerging all over the world.     Carbapenemases represent a major public health problem because of the risk of therapeutic     impasse and their high epidemic potential.   "
37165|NCT02799212|"     Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from     underlying liver disease and are exposed to the risk of postoperative ascites, with     subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged     hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow     and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for     modulating the portal inflow would be of interest: it could be used temporarily during the     early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known     drug already used in several indications, may limit the risk of postoperative ascites and     liver failure by decreasing portal pressure after hepatectomy for HCC in patients with     underlying liver disease.   "
37166|NCT02799199|"     Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at     least 6 months in the east of France from January 2011 to December 2014.      Background: The Grand-Est is a geographical region in France with a high prevalence of     multiple sclerosis (more than 10000 patients registered in the European Database for Multiple     Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients     have been treated for at least 6 months with Fingolimod, the first oral therapy for patient     with very active relapsing-remitting MS.      Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod     in the 6 university hospitals, general hospitals and private neurologists were reviewed in a     retrospective study after identification of the clinical files reported in the EDMUS     database.   "
37488|NCT02794935|"     This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea     hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive     function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in     patients with heart failure and obstructive sleep apnea syndrome.   "
37167|NCT02799186|"     Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute     Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk     factors. The origin of SCAD remains uncertain but a strong and frequent association with     Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only.      The aim of our study is to assess the presence of FMD and its genetic determinants i in a     sample for haematoma or spontaneous coronary artery dissection.      From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients     admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than     30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging     data will be reviewed by two experienced interventional cardiologist experts in SCAD     diagnosis.      For each patient a genetic analysis will be performed. A systematic screening for FMD will be     realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac     arteries and reviewed by two experienced radiologists. A one year follow-up is expected.      This study aims to confirm the presumed association of FMD and SCAD through the exploration     of several artery beds and the study of confirmed genetic determinants, which has never been     described previously to our knowledge.   "
37168|NCT02799173|"     Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of     osteoporosis and cardiovascular calcification. It has also been suggested that bone     remodelling and cardiovascular calcification are regulated by the same mechanisms, but     inversely in terms of calcium deposition, as osteoporosis is often associated with     cardiovascular calcification. Inflammatory and immune factors have been implicated in these     two processes.      The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the     last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts,     while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of     smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this     phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the     role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly     established, its role in vascular calcification is only hypothetical at the present time.      This study will focus on patients with SLE diagnosed and followed in the Amiens University     Hospital Internal Medicine and Nephrology departments   "
37169|NCT02799160|"     This observational study evaluates the clinical, biochemical and haemodynamic effects of     large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation   "
37170|NCT02799147|"     Several groups have demonstrated very low incidence of acute and chronic graft-versus-host     disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical, unrelated     and related allogeneic stem cell transplantation (SCT). Nonetheless for majority of the     grafts, except for 10/10 HLA-matched bone marrow, with this type of prophylaxis require     concomitant administration of calcineurin inhibitors±MMF, which delays immune reconstitution     and development of graft-versus-leukemia (GVL) effect. So, despite reduction of     transplant-related mortality, use of PTCy doesn't lead to the reduction of relapse incidence.     This is particularly important for relapsed or refractory acute leukemia patients, where,     despite all efforts to intensify conditioning regimens, relapses after SCT occur in more than     50% of patients, and long-term survival rarely exceeds 10-20%. In preclinical model of     haploidentical SCT the substitution of post-transplantation cyclophosphamide with     bendamustine, led to comparable GVHD control, but significantly augmented GVL effect. To test     this hypothesis and improve the outcome of allogeneic SCT in refractory acute leukemia     patients we initiated a pilot trial with high-dose post-transplantation bendamustine for GVHD     prophylaxis. The selection of doses is based on the previous dose-escalation studies.     Additional immunosuppression could be added for mismatched grafts.   "
37171|NCT02799134|"     CAR is short for cortisol awakening response. The neural mechanism of CAR effect on     high-order cognition and social cognition is less known...   "
37172|NCT02799121|"     This prospective case series is to gain additional clinical experience in the treatment of     diabetic foot ulcers, by documenting and relating patient history (including baseline wound     characteristics) and clinical outcomes (incidence of healing, rate of healing, and patient     and physician satisfaction) in a group of study participants for whom the ReGenerCell™     Autologous Cell Harvesting Device (ReGenerCell™) is used in combination with conventional     therapy for the closure of diabetic foot ulcers (DFUs). Participants will receive     ReGenerCell™ treatment in addition to standard care (debridement, cleansing, dressings,     offloading).   "
37173|NCT02799108|"     Recent data published by various laboratories as well as our preliminary data tend to prove     that near-infrared spectroscopy can be used to determine the lateralization of language as     part of the preoperative assessment for drug-resistant epilepsy. The reference test used up     until very recently was the Wada test, which consisted of injecting an anaesthetic (generally     amobarbital sodium) into one of the internal carotid arteries (right or left) in order to     determine the predominant cerebral hemisphere for language. This invasive test has been     progressively replaced by fMRI, which is nevertheless difficult to perform in children under     the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast     with fMRI, can be easily repeated and allows simple investigation of the various facets of     language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a     unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development     of language structures.   "
37174|NCT02799095|"     To better understand the safety and tolerability of ALKS 4230 in humans   "
37193|NCT02798848|"     This pilot randomized controlled trial (RCT) will test the methodology for a full RCT of     assistive technologies for children/young people with low vision/blindness. The investigators     will recruit 40 students age 10-18 years in India and the UK, who will be randomised into two     groups. Apple iPads will be the active intervention; the control arm will be the local     standard low-vision aid care. Primary outcomes will be acceptance/usage and accessibility of     the device and trial feasibility measures. Exploratory outcomes will be validated measures of     vision-related quality of life for children/young people as well as validated measures of     reading and educational outcomes. In addition, the investigators will carry out     semistructured interviews with the participants and their teachers, and attempt to evaluate     cost-effectiveness.   "
37181|NCT02799004|"     Pain is one of the most common complaints in emergency department (ED) and is still often     poorly managed. A major prospective multicenter study reported that 74% of patients that had     a pain complaint at ED triage are discharged in moderate to severe pain. Accordingly,     physicians frequently prescribed analgesic after discharged for these patients, and opioid is     given in 29% of ED visits involving pain complaints. However, few studies evaluate pain     management after ED discharge: the frequency and length of opioids prescriptions, the opioids     quantity taken by the patients, are the patients relieved and satisfied by these pain     treatments, what are the adverse effects associated with the use of these medications, and     what are the chances of developing addiction?      The primary aim of this study is to determine the required minimal opioids prescription for     patients treated for acute pain after being discharge from the ED. Secondary objectives     include: 1) monitor the patients' adverse events during opioids treatment; 2) evaluate the     patients' level of pain relief associated with their respective opioids treatment; 3)     determine the patients' level of addiction following post-ED opioids treatments.      The design of the project is a prospective observational cohort study. A cohort of     consecutive ED patients aged 18 or more with an initial pain at triage of 4 or more and     discharged from the ED in less than 48 hours with a prescription of opioid will be asked to     participate in the study. Patients will be excluded if there is ongoing treatment for a     pre-existing chronic pain condition or if they used opioid drugs in the past year. Research     nurses will contact the patients by phone at three follow-up time points (1 week, 1 month,     and 3 months). Follow-up phone interviews will evaluate pain intensity as well as pain     treatment satisfaction (0-10 NRS), monitor adverse events, and investigate possible opioids     addiction (SOWS: subjective opioid withdrawal scale). During these interviews, the nurses     will also question the patients about their daily opioids usage and if they were relieved     from pain.      This study will provide the base for future guidelines regarding the prescription of opioids     treatment for specific pathology encountered in ED. It will also give indications on how to     adjust the treatments according to adverse events and the level of addiction experienced by     patients.   "
37182|NCT02798991|"     The current study is designed to assess the safety, tolerability, pharmacokinetics (PK),     gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses     of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized,     double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be     randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.   "
37183|NCT02798978|"     This study is an ascending dose first-time-in-human study to determine the safety,     tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in     healthy subjects. The results will support the design of future clinical trials of GSK1795091     administered to subjects with advanced malignancies in combination with immune system     modulators.      Part 1 will be a randomized, double-blind (sponsor-unblinded), placebo-controlled, single     center, single dose escalation, sequential group evaluation of intravenously administered     GSK1795091 to evaluate the safety and tolerability in healthy subjects. Part 2 will be an     open-label, parallel group evaluation of 2 doses of GSK1795091 administered, either 1 week     apart (Part 2, Cohort 1) or 2 weeks apart (Part 2, Cohort 2). In Part 2, on Day 1, subjects     will receive intravenous GSK1795091 at a dose determined by results from Part 1. The total     duration of this study is approximately 10 weeks from screening to the last study visit.   "
37184|NCT02798965|"     Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young women.     Although the aetiology and pathogenesis remain obscure, the most widely accepted hypothesis     is an interaction between a genetic predisposition and an environmental trigger factor such     as viral infection. Parvovirus infections have been proposed as trigger factors for     Hashimoto's thyroiditis and Graves' disease.   "
37185|NCT02798952|"     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B     in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the     first two years of life and to assess the anamnestic response, immunogenicity, safety and     reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.   "
37186|NCT02798939|"     Bacterial infections are a major cause of mortality in cirrhotic patients in the context of     gastrointestinal bleeding or spontaneous bacterial peritonitis (SBP). Rapid diagnosis of SBP     is therefore an important research goal because the gold standard neutrophil count in ascitic     fluid cannot be performed 24 hours a day in all healthcare structures. The use of urine     dipsticks in ascites cannot be recommended at the present time due to their insufficient     sensitivity with an unacceptable risk of false-negatives in the context of a fatal disease     for which effective antibiotic therapy is available. Ascitic fluid lactoferrin assay has     recently been demonstrated to be a very good diagnostic test for SBP. The investigators plan     to conduct a prospective study on lactoferrin as well as procalcitonin (PCT) to determine the     best laboratory test(s) for the rapid, automated diagnosis of SBP. These tests will be     compared with the Aution® urine dipstick, which has been shown to present better diagnostic     sensitivity than the Multistix® dipstick . This single-centre study (Amiens University     Hospital) will be performed in the context of routine clinical practice on ascitic fluid that     is usually incinerated.   "
37187|NCT02798926|"     Particular attention is paid to thermal management of preterm neonates in neonatal intensive     care units because of the major risk of morbidity associated with hypothermia. Percutaneous     central venous catheter placement is essential to ensure adequate caloric intake and     intravenous administration of treatments, but this procedure can cause major body temperature     variations, responsible for complications in these neonates, as convection incubator function     is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours)     depending on the technical difficulties encountered during catheter placement.      In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal     transport is now clearly defined and ensures stability or even a considerable temperature     gain during transfer immediately after birth. In the light of several clinical cases, the use     of a polyethylene bag during central venous catheter placement appears to be effective to     prevent body temperature loss in preterm neonates. No data are currently available concerning     the value of this method of prevention of hypothermia during this type of procedure.      Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet     could be useful during this procedure by significantly reducing heat loss caused by     convection and evaporation. However, compensation phenomena such as generalized     vasoconstriction to cold in preterm infants are very poorly described, but can induce a     functional conflict between mechanisms ensuring maintenance of homeostasis and those involved     in maintenance of blood pressure.   "
37188|NCT02798913|"     The objective of the present study was to evaluate the prognostic impact of prolonged dual     antiplatelet therapy (DAPT) with acetylsalicylic acid plus clopidogrel on the incidence of     major adverse cardiovascular events and major adverse limb events after percutaneous lower     extremity revascularization in patients with lower extremity peripheral arterial disease     (LE-PAD).   "
37189|NCT02798900|"     The aim of this study is to evaluate the effect of a functional task-training program     combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality     in adults with hip osteoarthritis.   "
37195|NCT02798822|"     Posterior crossbite is a common clinical condition often associated with transverse maxillary     deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting     and can lead to the development of craniofacial asymmetries and mandibular dysfunction.      The aim of the current study was to evaluate maxillary and mandibular arch widths' response     to RME when it is anchored to the upper second deciduous molars or to the upper first     permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition     patients.   "
37196|NCT02798809|"     The aim of the study is to follow a group of preschool children from early permanent     dentition to determine the prevalence and incidence of caries malocclusions and to     investigated the related risk factors as age, gender, ethnic origin and non-nutritive sucking     habits, breathing disturbances, allergies, Dietary habits, oral hygiene status and dental     care.   "
37197|NCT02798796|"     The aim of this study is to evaluate the ability of MRI to select patients for conservative     treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I,     II and III candidates for conservative surgery will be randomly randomized to do MRI or not     according mammary density.   "
37198|NCT02798783|"     People with the congenital anatomical malformation known as Enlarged Vestibular Aqueduct     (EVA) may experience decline in hearing ability. This is an online registry to gather patient     experiences with EVA, with the goal of providing future researchers with the information     necessary to better evaluate and make recommendations for patients with EVA. Data will be     obtained from volunteers who enroll and submit their information on a website,     https://eva.uhhospitals.org, and a limited data set may be provided to researchers interested     in analyzing repository data. The limited data set would not contain any identifiable     information except for ages, dates such as date of diagnosis, or city/state of residence.      EVA Research Project Website: http://rainbow.org/EVAResearch      EVA Patient Registry Website: https://eva.uhhospitals.org   "
37199|NCT02798770|"     Ischemic stroke is the leading cause of acquired disability among adults, and one of the main     causes of death. In Switzerland, the approved time window for stroke treatment with     intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window,     however, the benefit of treatment strongly decreases as time passes.      Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke     arrive too late to the hospital (prehospital delay). Despite efforts to educate the community     on the symptom of stroke, prehospital delay did not decrease over time, and the reasons     remain incompletely understood. Prehospital delay reduces the proportion of patients with     ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among     the minority treated with thrombolysis.      This prospective cohort study aims at understanding the causes of prehospital delay among     patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside,     patients and proxies along a standardized questionnaire on prehospital delay. Avoiding     modificables causes of prehospital delay may increase the thrombolysis rate and improve     outcomes after stroke.   "
37200|NCT02798757|"     This is a phase IV study that will explore the mechanisms of action of a drug (dapagliflozin)     that is already commercially available in the country where the study will be conducted     (Greece). The drug will be used according to its approved clinical indications (as add-on     treatment in patients failed to achieve glycemic targets on metformin monotherapy) and in the     approved posology (10 mg/day). Additionally, although there is limited data on the     coadministration of dapagliflozin with thiazides, the excellent safety profile of the drug     even when it is used in combination with drugs that induce significant volume depletion (such     as loop diuretics) suggests that, in properly selected patients, the possibility of important     adverse events during the coadministration of dapagliflozin with chlorthalidone is very low.     All patients will give written informed consent prior to their enrollment in the study. The     study protocol will be approved by the scientific committee of the University Hospital of     Ioannina.   "
37201|NCT02798744|"     The aim of this study is to investigate the cause for the discrepancy in predicted and     observed weight loss with Empagliflozin (Jardiance™) by measuring appetite regulation.      Major secondary objectives are to determine the effects of Empagliflozin (Jardiance™) on     energy expenditure and change in total body weight and body composition.      The primary outcome is change in appetite hormone concentrations (specifically total PYY)     between baseline and 24 weeks: - this will be measured by sequential blood sampling during     visits 1-5.      Secondary outcomes, which are exploratory, are effect on appetite hormones (ghrelin and     GLP-1), appetite perceptions, total body weight and fat and fat free mass, energy     expenditure, appetite perception, physical activity and blood and urine biochemical     parameters after Empagliflozin (Jardiance™) treatment for 24 weeks.      The sample size for the study is 76 participants and the planned trial duration is 21 months,     with participants receiving approximately 24 weeks of exposure to Empagliflozin (Jardiance™).   "
37202|NCT02798731|"     The aim of the study is to evaluate the impact of early microvascular disease assessed by     coronary physiologic indices such as fractional flow reserve (FFR), coronary flow reserve     (CFR), index of microvascular resistance (IMR) on future occurrence of cardiac allograft     vasculopathy (CAV) in heart transplant recipients.   "
37203|NCT02798718|"     Milk is the source of high-quality protein, calcium, and other vitamins and minerals.     Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome,     T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease.     However, milk contains disaccharide lactose, which may cause gastrointestinal problems in     those adults with poor digestion. Recent studies have shown that subjects with intolerance to     lactose tend to reduce their consumption of milk. Actually, consumption of 12g lactose (240ml     milk) per day produces negligible symptoms in lactose intolerant. Furthermore, a dairy-rich     diet could improve lactose intolerance because of colonic adaption to it. Lactose     maldigestion would not be a restricting factor in milk intake. In general, the undigested     lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain     fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have beneficial effects     on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal     flora profile. But there are few studies evaluating effect of milk intake on health of people     with lactose malabsorption or intolerance.This trial intend to study the effect of whole milk     on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.   "
37204|NCT02798705|"     The aim of the study is to evaluate coronary flow reserve (CFR), index of microcirculatory     resistance (IMR), and proportion of overt microvascular disease, defined as depressed CFR as     well as elevated IMR in patients with cardiac amyloidosis. The second objective of this study     is to compare results of non-invasive test including serum light chain amount, Doppler     echocardiography with 2D strain, and cardiac perfusion MRI.   "
37205|NCT02798692|"     The objectives of this first-in-human is to evaluate the safety and the immunogenicity of     three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three     different dose levels.   "
37206|NCT02798679|"     The purpose of this study is to determine whether pre-existing cardiac fibrosis is a     predictor of cancer treatment-related cardiotoxicity.   "
37207|NCT02798666|"     Background and aims: The purpose of this study was to evaluate the effect of high intensity     interval training (HIIT) on body composition, physical fitness, metabolic fitness and muscle     histology in men with overweight or obesity compared to continuous aerobic training (CAT).      Material and methods: 16 male participants with overweight/obesity (age range: 42 - 57 years,     body mass index: 28 - 36 kg/m²) were randomized to HITT (n=8) or CAT (n=8). HIIT was composed     of two sprint blocks of 10 minutes at ventilatory threshold (VT), within between a continuous     block of 10 minutes, twice a week for 15 weeks. CAT was composed of three blocks of 10     minutes continuous endurance training at VT. After 5 weeks, intensity was increased to 110%     of VT. Changes in body composition, physical fitness (peakVO2 and anaerobic threshold (AT)),     basal respiratory exchange ratio (bRER) and insulin sensitivity by oral glucose tolerance     test were evaluated. Mitochondrial content was evaluated by transmission electron microscopy     (TEM) in muscle biopsies.   "
37208|NCT02798653|"     This study is a randomized clinical trial to investigate the efficacy of different luteal     phase support methods in patients with poor ovarian response undergoing IVF and     intracytoplasmic sperm injection (ICSI) cycles.      The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan     institute. The study is conducted according to the Declaration of Helsinki for medical     research. All participants provide informed consent after counseling for infertility     treatments and routine IVF/ICSI programs.   "
37209|NCT02798640|"     The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred     change in local cutaneous blood flow, in healthy subjects wearing a control and a 100%     Celliant® fiber upper torso garment.   "
37210|NCT02798627|"     NS2359 attenuates the euphoria associated with cocaine use. In a manner parallel to cocaine,     NS2359 blocks the reuptake of dopamine (DA), norepinephrine (NE), and serotonin (5HT) with     nanomolar affinities at the 3 transporters. In primates NS2359 significantly attenuated     cocaine self-administration. In several phase II clinical trials for major depressive     disorder and adult attention deficit disorder, NS2359 did not cause euphoria. NS2359     exhibited no abuse potential in a human laboratory study comparing NS2359 with amphetamine.     In a phase I human laboratory interaction study, NS2359 showed no toxicity after 20 or 40 mg     of cocaine, but it attenuated the both the rewarding and cardiovascular effects of     intravenous cocaine. On the basis of these promising studies, investigators propose a Phase     II double-blind clinical trial of NS2359 in cocaine addiction (CA). The proposed trial will     involve 100 CA subjects participating in an eight week trial, including a 1-week baseline and     8 weeks of NS2359 or placebo treatment. Four weeks after completing the medication phase,     there will be one follow-up visit. Subjects will be randomly assigned to treatment with     placebo or 2 mg NS2359 daily, with a possible decrease to 1 mg daily for adverse events. This     dose range is selected on the basis of phase I and II evidence of tolerability and NS2359     plasma levels which were associated with blockade of cocaine reward. This project has the     potential to identify the first effective pharmacotherapy for CA.   "
37211|NCT02798614|"     The purpose of this study is to compare the radiographic and clinical outcomes after short     versus conventional plaster cast fixation time in reduced distal radius fractures.   "
37212|NCT02798601|"     The purpose of this study is to estimate the effect of an early induced hypernatremia     protocol (150-155 milliequivalent/L) versus normonatremia plus mannitol (135 - 145     milliequivalent/L) in terms of neurologic outcome in patients with severe traumatic brain     injury managed at critical care unit.   "
37213|NCT02798588|"     In last decades, several advances in the neuro-intensive management have lead to decrease     mortality in Intensive Care Units. A significant morbidity remains as patients survive after     a traumatic coma with uncertain quality of awakening and a high risk of functional     disability. Predicting awareness recovery and functional disability of those who will awake     constitutes a major challenge to inform patients' relatives, to give the best chances in     terms of rehabilitation resources or to adapt intensive cares to a reasonable level. Tools     currently available are not sufficient neither to predict bad awakening outcome nor to     predict good functional outcome. In many countries, life's support cessation is a constant     call for robust evaluation as soon as possible in ICU but it is mandatory to reach a positive     predictive value of non-awaking close to 100%. Many clinical, electro-physiological,     biological, radiological and functional parameters have been conducted with comatose patients     assuming the purpose to predict outcome. Regarding unfavourable outcome, the gold standard is     the abolition of the N20 component of somatosensory evoked potentials but the specificity is     high enough only for patients with anoxic coma. Several neurophysiological markers such as     MMN, P300 are correlated to a favourable outcome but the sensitivity and specificity remains     low for patients who suffered a severe traumatic brain injury. New Diffusion Tensor imaging     sequences provide complementary information to detect small structural lesions (diffuse     axonal lesions). Recently, functional MRI analyzing Resting State has also been proposed as a     prognostic marker during coma. PET using Fluoro-Desoxy-Glucose is able to assess the     metabolism in key regions of the awakening network in either anaesthesia or sleep. Recent     studies have reported interesting results at the chronic stage but to knowledge, these tools     have only been used to address pathophysiology's issues and never to improve coma prognosis     at the initial stage. The investigators hypothesize that the heterogeneity of the population     requires a global and accurate assessment of the central nervous system, combining     structural, metabolic and functional information in order to refine the prognosis.      The protocol integrates in one-sequence most radiological markers of brain injury within a     unique PET-MRI in Lyon. The most relevant originality of the study consists in confronting     FDG-PET and MRI sequences to a large clinical, electrophysiological and biological battery.     The added clinical value would be to question the synergistic effect of each parameter and to     find out which ones are the most useful for awakening prediction, as they have not been     compared in a multi-parametric database.      PET-MRI, as a new device combining physiological and prognostic questioning, allows us:        -  to implement a more integrative physio-pathological analysis        -  to avoid the cofounding effect of awareness' fluctuations in recording simultaneously          multiple functional imaging techniques.      The RS will be analyzed at 2 epochs in order to assess the stability of brain connectivity,     related to neuronal activity (glucose metabolism) and brain perfusion.   "
37248|NCT02798107|"     Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with     very high affinity. Idarucizumab potently and specifically binds to dabigatran and its     metabolites and neutralises its anticoagulant effect. A clinical development program is     ongoing to support marketing authorisation submissions for idarucizumab indicated in patients     treated with dabigatran who require emergency surgery/urgent procedures or who have a     life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of     dabigatran is required.   "
37214|NCT02798575|"     Detecting exacerbations to prevent a severe and / or to early treat an exacerbation is     crucial in patients with COPD in order to prevent hospitalization. Patients with invasive     mechanical ventilation outside the hospital have a high re-hospitalization rate which is     associated with severe economic burden since those patients need to be treated mainly on an     ICU or a respiratory ward being able to take care of invasive mechanical ventilation.      Recently, it has been shown that daily variations of parameters recorded by non-invasive     ventilation (NIV) software are predictors of exacerbations in a cohort of COPD patients being     treated outside the hospital with NIV [1]. These parameters were respiratory rate and     percentage of respiratory cycles triggered by the patient.      The aim of the present study is to detect parameters recorded by the ventilator which are     able to predict exacerbation and / or hospitalization in patients with COPD under invasive     mechanical ventilation outside the hospital.   "
37239|NCT02798224|"     To compare patient perceptions, intent to screen, and screening use among those using a     patient portal with and without a colorectal cancer (CRC) screening decision support tool,     e-assist.      To evaluate whether the effectiveness of e-assist is moderated by multi-level factors,     including patient health literacy, decision-making preference, and CRC screening decision     stage.      To assess program impact and create an implementation guide for e-assist by combining results     from Aims 1 & 2, a program implementation analysis/process evaluation and the perspectives of     staff from future diverse implementation sites including small primary care practices,     University-based primary practices and federally-qualified health centers.   "
37215|NCT02798562|"     The aim of this study is the clinical establishment of a native and contrast-enhanced     computer tomography of the breast. The early detection of breast cancer is still a great     challenge. Even though the implementation of the digital mammography combined with the     mandatory screening-programs lead to significant improvements, sensitivity and specificity of     these examinations need to be clearly classified as improvable. Generally, it is stated that     the necessary transit from 2-D projected images to 3-D tomography will be crucially     advantageous as magnetic resonance imaging has already shown. Similar or even major     advantages can be expected by new approaches regarding CT with very high local resolution,     better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening.     A device that meets these demands and is also applicable for dynamic scans after intravenous     administration of a contrast agent, has been developed with the support by the European Union     (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF).     Publications on technical and experimental results are already available. An evaluation in     the clinical use is missing yet. The primary aim of this study is to evaluate systematically     the performance of the native and dynamic, contrast-enhanced CT of the breast.   "
37216|NCT02798549|"     The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough     understanding of the biology of one of its major causative agents, the hepatitis B virus     (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is     mounting evidence on several viral species that virion-bound proteins are prone to be     involved either at the replication, budding/egress or entry/release steps of the viral cycle.      Identifying such targets may yield ideal candidates for gaining insight on the dependence of     HBV upon a restricted subset of host proteins, therefore providing refined sets of     genetically stable targets for therapy. This project's goals are to set up adequate     conditions for robust and reproducible purification of HBV virions in clinical samples,     followed by the identification of their HBV-bound host proteins and the characterization of     their functions. Proteomics profiling of HBV particles purified from clinical samples will be     overlaid with proteins identified and characterized in cell culture grown HBV particles,     using clinical biomarker discovery grade criteria. Targets identified in both samples sets     will be subjected to in vitro investigations using HBV-replicating cells. Conventional     biochemical and imaging methods will be used in order to: (i) ascertain their physical     association with HBV virions; (ii) define the modalities of their interaction with HBV     proteins; (iii) decipher the topology and subcellular localization of their association with     HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle     budding, egress or secretion and infectivity. A candidate that yielded satisfactory results     in these experiments will be disclosed and further investigated at the level of structural     biology, in collaborative research programs.   "
37217|NCT02798536|"     Background:      LMB-100 is a man-made protein. It is attracted to the mesothelin protein. This is found in     many tumors, including mesothelioma. But it is found in only a very small number of normal     tissues. After binding to mesothelin on tumors, LMB-100 attacks and kills cancer cells.     Researchers want to test LMB-100 in people with advanced mesothelioma.      Objective:      To find a safe dose and anti-tumor activity of LMB-100 for people with advanced mesothelioma.      Eligibility:      Adults ages 18 and older with:      Advanced pleural or peritoneal mesothelioma that has not responded to platinum-based      therapy      Adequate organ function      Design:      Participants will be screened with:      Samples of tumor tissue or tumor fluid. These can be new or from a previous procedure.      Medical history      Physical exam      Blood, urine, and heart tests      Chest x-rays      CT or MRI scans      FDG-PET scans      Participants will get LMB-100 on days 1, 3, and 5 of each 21-day cycle. It will be given     through an IV catheter, a tube inserted in an arm vein. They will get standard medicines     before each infusion to help prevent side effects. Each infusion lasts about 30 minutes. They     will be monitored for up to 2 hours after.      During each cycle, participants will repeat the screening tests.      Participants will get the study drug for up to 4 cycles or until their disease worsens or     they have intolerable side effects.      About 4 6 weeks after their last infusion, participants will have a follow-up visit. They     will repeat the study tests.      Participants will have follow-up scans every 6 weeks until their disease gets worse.      Participants will be called about once a year to see how they are doing.   "
37236|NCT02798263|"     The pain is very common complaint, and the neck is one of the most affected spots, mainly due     to muscle contracture of the cervical and scapular region, triggered by emotional stress     associated with muscle retraction involved resulting from postoperative scarring or     post-radiotherapy.O fear fibrosis move the limb and inactivity postoperative lead to gradual     impairment of muscle strength and flexibility, and loss of ADM, which also predisposes to the     appearance of pain.      Goals Study the effectiveness of acupuncture in rehabilitation of physical and functional     disorders of women undergoing surgery for breast cancer.        1. Presence of pain by Visual Analog Scale of Pain (VAS).        2. Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension,          adduction, abduction, internal rotation and external rotation        3. lymphedema presence through top member perimetry.        4. upper limb function through the DASH questionnaire.        5. Depressive symptoms through BECK questionnaire.        6. Quality of life through the EORTC questionnaire.        7. Muscle strength of flexion, extension, adduction, abduction, internal rotation and          shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette          Instrument Company.      Patients will be divided into three randomized groups with 30 patients per group, who will     receive weekly treatment for 10 weeks, and the group I treated with standard therapeutic     exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and exercises     for ADM upper limb lasting 30 minutes; group II is treated com30 minutes classical     acupuncture using pre-defined spots, and finally, grupoIII be used in the same acupuncture     points of the group II, but using the Stiper® in place of the needles. If the patients in     groups II and III still of pain at the end of 10 sessions will be treated complementarily     with kinesiotherapy.   "
37241|NCT02798198|"     Objective: The main target of this study was to research the early changes in pulmonary     function and intrarenal hemodynamics, then research the correlation between the pulmonary     function and the renal hemodynamics in type 2 diabetes (T2DM) patients without diabetic     kidney disease (DKD).      Method: 37 T2DM patients (diabetes group) without DKD and 33 healthy people (control group)     were choosed to research early changes in pulmonary function and intrarenal hemodynamics,     then research the correlation between the pulmonary function and the renal blood flow in T2DM     patients, all having normal renal function. The primary endpoints were the pulmonary function     parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the     secondary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral     interlobular renal arteries were evaluated using; the tertiary endpoints were the biochemical     variables: blood-fat (TC, HDL-C, LDL-C, and TG), renal function parameters (BUN, Cr, and     GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR)     were measured.   "
37218|NCT02798523|"     Background:      The immune system defends the body against bacteria and other harmful invaders. But it can     overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs)     can calm down an overactive immune system. But they often cause negative side effects.     Researchers want to learn how human genes respond to GCs. Genes live inside each cell of the     body. They tell our cells how to function. Researchers hope the results of this study will     show them how to develop better drugs that will have the benefits of GCs without the side     effects.      Objectives:      To study how human genes respond to glucocorticoid drugs.      Eligibility:      Healthy adult volunteers ages 18 64.      Design:      Participants will be screened with a medical history and physical exam. They will have a     heart test and blood tests.      The study visit will last about 6 hours.      Participants will have medical history, physical exam, and 3 blood draws.      Participants will have a skin biopsy. An injection will numb the skin on one arm. Then a tool     will remove a piece of skin about as big as a pencil eraser.      A GC cream will be applied to the other arm.      Participants will get the GC study drug for 30 minutes. It will be a liquid that will drip     through a needle placed in an arm vein.      Participants will have a skin biopsy of the arm that had the cream applied.      Participants will have follow-up calls 1 and 4 days later. They will be asked about reactions     or other health problems.   "
37219|NCT02798510|"     The present study is designed to determine whether adjuvant concurrent chemoradiotherapy     improves overall survivals.   "
37220|NCT02798497|"     Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine     leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and     soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet,     2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like     symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute     respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet,     2002;359:753-9). Ten year after the first description of this disease and a number of     controversies in the scientific literature, the question arise as to whether PVL remains an     independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain     unanswered yet; these are:        -  (i) which factors, including treatment regimen, are associated with favourable outcome?,        -  (ii) what is the susceptibility toward antibiotics of strains associated with this          disease ?        -  (iii) is there any genetic susceptibility of the host to explain both the rarity, and          the explosive presentation of the disease ? To address the above questions a prospective          observational study at the nationwide level will be set up. All French hospitals will be          invited to describe the clinical features of all new cases of S. aureus          community-acquired pneumonia with severity criteria, regardless PVL production. The          study will include an investigation of a possible innate immune dysfunction in          collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses, Faculté          Necker, Paris). Hence, in addition to collecting clinical and biological data from all          pneumonia cases as well as all strains of S. aureus isolated, the patients with          PVL-positive pneumonia will be sampled for immune genetic studies (ORFeome sequencing          and functional studied)   "
37221|NCT02798484|"     Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the     loco-regional staging and direct the treatment.      European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement     of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care     consists of realizing a MRI before the start of the NAC and another one after it's ended, six     months later.      There is currently no consensus on the realization of an interval MRI for early assessment of     the chemosensitivity of the tumor. It would allow though alterations in the therapeutic     regimen in the event of a non response. Similarly, there is no consensus on when this     interval MRI should be performed.      Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting     for the evaluation of the early response. However, these are preliminary studies with     quantitative measures realized by the region of interest (ROI) method. A response to     neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC).      The investigator's goal for this study is to evaluate the reliability of diffusion as tumor     biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted     magnetic resonance sequences in the pre-therapeutic assessment and the early and late     follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...)     within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI     results obtained at the end of the treatment and with the histology of the initial biopsy and     the surgical specimen.      The expected benefits are:        -  to establish correlations between apparent diffusion coefficients (ADC) values and          histology        -  to observe changes in the ADC according to the type of response: ADC increase in the          event of partial response, ADC stability in the event of non response, ADC decrease in          the event of a progression, absence of restriction in the event of a complete response.        -  to confirm that diffusion weighted MRI within a short interval (after one cure, at one          month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.   "
37222|NCT02798471|"     This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint     evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is     designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to     compare the efficacy and safety of edoxaban against standard of care in pediatric subjects     with confirmed VTE.   "
37223|NCT02798458|"     Patients will undergo a SmartPill test to gain additional understanding of Fabry disease     manifestation via motility abnormalities in order to improve symptom targeted therapy. An     additional Endoscopic mucosal resection may be performed on further qualifying patients.     Tissue analysis from this biopsy will include evaluation of abnormalities of cellular     structure and morphology with correlation with gastrointestinal complaints for each patient     and comparison against age matched non-Fabry patient tissue. The hypothesis is that patients     with fabry disease will have abnormal motility which will correlate with the patients     symptoms and quality of life as noted on the questionnaires.   "
37224|NCT02798445|"     The aim of this study is to determine the percentage of healing of active venous ulcers     following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and     adjustable compression system versus a control group using the traditional multilayer     bandages.   "
37237|NCT02798250|"     In previous studies, investigators have studied if a pre-meal insulin bolus based on     estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without     a significant degradation in postprandial glucose control. With this strategy, the patient     would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,     large or very large). It is however important to establish the safety of this simplified meal     bolus approach. The safety of overestimating a meal insulin bolus in the context of     closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop     will be tested.      Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus     will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an     adequately estimated meal size bolus.   "
37249|NCT02798094|"     The goal of this project is to learn more about the different ways in which people process     information that is stressful and rewarding, and how abnormalities in these two processes are     related to depression.   "
37678|NCT02792465|"     This is a phase 1 study of investigational agent CFI-402257 in patients with advanced cancer.     The purpose of this study is to see how safe and tolerable CFI-402257 is in cancer patients     as well as the pharmacokinetics (PK). This study is the first time that CFI-402257 is given     to humans.   "
37225|NCT02798432|"     Early total knee arthroplasty (TKA) implant systems most frequently used an all-polyethylene     cemented tibial component1. Based on finite-element analysis studies reporting superior force     distribution compared with conventional all-polyethylene components, metal-backed tibial     baseplates have dominated the TKA implant market since the middle of the 1980's2. These     modular implants provided excellent long-term implant survivorship3.      As TKA became increasingly successful, younger patients increasingly became eligible.     Increasing life expectancy has raised the concern that cemented TKAs may not withstand     prolonged use, particularly in younger patients4. Patients younger than 65 years are     projected to account for more than 50% of patients undergoing TKA by 2016 and to more than     50% of patients undergoing revision surgery by 2011. The number of total knee revisions in     the United States is expected to increase from 38,300 in 2005 to 268,200 in 20305.      Many authors have reported excellent and equivalent results of cemented and cementless     TKA6-8. Despite these encouraging reports, the major concern with cementless TKA has been the     tibial component, and, therefore, the preference for many surgeons still remains to cement     the tibial component9,10. The femoral component may be the most suitable for cementless     fixation11-13. However, the best femoral method of fixation is still being discussed.     Currently, the decision to cement or not to cement the femoral component is based on the     surgeon's preference14.      The current study was designed to compare the hybrid NexGen LPS (Zimmer Inc, Warsaw, IN) and     the cemented NexGen LPS. The purpose of this study is to establish whether the hybrid NexGen     LPS leads to equally successful results as the cemented TKA gold standard   "
37226|NCT02798419|"     DFD05 vs. Active01 in the treatment of common warts   "
37227|NCT02798406|"     Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant     brain tumor in adults and can be resistant to conventional therapies. The purpose of this     Phase II study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds     to one injection of DNX-2401, a genetically modified oncolytic adenovirus, when delivered     directly into the tumor followed by the administration of intravenous pembrolizumab (an     immune checkpoint inhibitor) given every 3 weeks for up to 2 years or until disease     progression.      Funding Source-FDA OOPD   "
37228|NCT02798393|"     This is a double blind, randomized, placebo-controlled study in which a total of 120 patients     will be selected from a broad spectrum group of typical Americans (all demographics including     various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes     Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients     will meet inclusion and/or exclusion criteria.   "
37229|NCT02798380|"     The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519     Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.   "
37230|NCT02798367|"     National clinical trials, phase III/II, combined in two stages, randomized, double-blind,     controlled, parallel, study of superiority, in which two hundred fifty-six (256) participants     of both sexes, aged equal or more than 55 years will be randomly allocated to one of three     treatment groups. In the first stage. The group 01 will use Melatonin 3mg plus CBT-I, the     group 02 will use Melatonin 5mg plus CBT-I and the group 03 will use CBT-I plus placebo.      Based on the results of an interim analysis will be making a decision on whether to proceed     with the study and, if so, on which the doses will be selected for the second stage of the     study, to be better studied. The final analysis of the treatments, melatonin in the selected     dose plus CBT-I versus CBT-I alone and placebo, will include participants from both stages.   "
37232|NCT02798341|"     TRACR will provide a data/biospecimen repository for translational research to better     diagnose, prognose, treat and cure breast cancer (and related diseases/treatment conditions).     Patients at the Rowan Breast Center will be consented for donation of blood and if available     tumor/healthy/archived tissue. Patients will be consented to give permission to use said     specimens for future research and to be contacted in the future about other research     participation and additional information.   "
37233|NCT02798328|"     Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and     classify the presence of DOAC drugs in a subject.   "
37234|NCT02798315|"     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)     has been shown to be safe and effective in randomized controlled clinical trials with strict     inclusion and exclusion criteria under well controlled conditions.      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±     RBV, used according to local label, under real world conditions in Israel in a clinical     practice patient population.   "
37235|NCT02798302|"     Healthy volunteers will participate in a crossover trial comparing preoxygenation with a     non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush     rate of oxygen (fully opening standard oxygen flowmeter).   "
37238|NCT02798237|"     Physical activity level is an important determinant of quality of life in persons     post-stroke. There is a lack of knowledge regarding the effects of aerobic training on     physical activity levels in subjects post-stroke. Therefore, the primary objective will be to     investigate the effects of aerobic treadmill training on physical activity levels and     sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the     effects of the training on cardiorespiratory fitness, endurance, depression, mobility,     quality of life, and participation.      A randomized controlled trial with blinded assessment will assign eligible participants to     either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve),     or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will     receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4     participants, by a trained physiotherapist. Primary outcomes: physical activity levels and     sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary     outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold),     endurance, depression, mobility, quality of life, and participation. The effects of the     trainings will be analyzed from the collected data and intention-to-treat analysis.     Between-groups differences will be measured by two-way ANOVA with repeated measures     considering the baseline, post-training, and a 4-week follow-up.      The results of this trial will likely provide valuable new information about the effects of     aerobic treadmill training in improving physical activity levels and sedentary behavior,     through changes in cardiorespiratory fitness, for individuals following stroke.   "
37243|NCT02798172|"     Objective: To observe the effect of alogliptin combined with metformin on pulmonary function     in obese patients with type 2 diabetes inadequately controlled by metformin monotherapy (500     mg, bid po, for at least 3 months), and evaluate its efficacy and safety.      Method: After a 2-week screening period, adult patients (aged 36-72 years) entered a 4-week     run-in/stabilization period. Then, patients were randomly assigned to either the intervention     group (n=55) or control group (n=50) for 26 weeks. The patients in the control group were     given metformin (1,000 mg, bid po) and the patients in the intervention group were given     metformin (500 mg, bid po) combined with alogliptin (25 mg, qd po). All the patients received     counseling about diet and exercise from a nutritionist during run-in and treatment periods.      The primary endpoints were the between-group differences in the changes pulmonary function     parameters [VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%] between     pretherapy and posttreatment. The secondary endpoints were changes from baseline to week 26     in HbA1c, FPG, 2hPG, HOMA-IR, WC, and BMI. The tertiary endpoints were the changes from     baseline to week 26 in blood-fat (TC, HDL-C, LDL-C, and TG). The quartus endpoints were the     changes from baseline to week 26 in SBP and DBP. The fifth endpoints were the changes from     baseline to week 26 in oxidative/antioxidative parameters (ROS, MDA, SOD, and GSH-PX). In     addition, safety endpoints were assessed (AEs, clinical laboratory tests, vital signs, and     electrocardiographic readings).   "
37244|NCT02798159|"     The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of     erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with     the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil     Citrate taken as needed over one month (phase III)   "
37245|NCT02798146|"     This pilot-study will help characterize the serum progesterone profiles in IVF patients and     correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous     gonadotropins.   "
37246|NCT02798133|"     The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low     tidal volume (VT) ventilation, with or without an individualized post-RM positive     end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.   "
37247|NCT02798120|"     This is a multi-center, open label long-term safety (LTS) study to be conducted in     approximately 600 subjects with acne vulgaris.   "
37438|NCT02795598|"     The investigators plan to determine the incidence of hemi-diaphragmatic paresis (HDP) with     two commonly used techniques of supraclavicular nerve block, the single and double injection     techniques.      It is our hypothesis that a double injection peripheral nerve block technique will increase     the risk of HDP when compared to a single injection technique.   "
37250|NCT02798081|"     A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course for     beginners will participate in the study. The evaluation will consist mainly in answering two     validated questionnaires on socialization, the short Social and Emotional Loneliness Scale     for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and     performance will also be measured by three virtual reality games, namely Reaction Time,     Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at     baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics classes     which includes 15 minutes for practicing virtual reality games.   "
37251|NCT02798068|"     Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal     insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an     intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation     alterations, specially in endothelial cell and its protective layer - glycocalyx. Endothelial     dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is associated     with bad prognosis.      High - dose corticoids administration at anesthesia induction in cardiac surgery could     attenuate the intensity of this inflammatory reaction, and represents the current practice in     our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery centres.   "
37252|NCT02798055|"     GRegistry is a significant collection of data and information on the clinical practice of     systemic scleroderma finger ulcers.      The GRegistry study is a nationwide (Greece) prospective study recording, which includes     consecutive patients with SC-DU diagnosis in clinical management departments of different     hospitals, selected in such a way as to reflect a representation of the country.      The use of Bosentan in the treatment of patients suffering from systemic sclerosis with     digital ulcer disease is supported by data from large, placebo-controlled, randomized     studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic     sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated     with connective tissue disease and its beneficial effect on vascular remodeling.   "
37253|NCT02798042|"     Acute kidney injury (AKI) is a common, but significant complication after elective surgery     which is associated with an increased risk of mortality, major adverse cardiac events,     prolonged length of hospital stay, and increased cost per episode of care.   "
37254|NCT02798029|"     The goal of this clinical research study is to learn if a type of radiation therapy called     frameless fractionated stereotactic radiation therapy (FFSRT) is effective for treating     participants with brain metastases. The safety of this therapy will also be studied.   "
37255|NCT02798016|"     Investigators will collect blood specimens from the participating patients and then blood     samples will be centrifuged in order to collect platelet-rich plasma which is going to be     injected in the atrophic acne scars. A split-face design is going to used in this randomized     controlled trial. In the control side of the face, micro-needling to the skin will occur     using a specific tool (Dermapen).   "
37256|NCT02798003|"     To study activity in the reward-circuitry of the brain in patients suffering from cachexia     induced by cancer or chronic disease.   "
37257|NCT02797990|"     Qualitative project, comprising open-ended semi-structured interviews with healthcare     workers, who provide antenatal care to substance-using women.   "
37274|NCT02797769|"     This retrospective cohort study will analyze data from multiple large U.S. health insurance     claims databases to compare use of tocilizumab to other biologic disease-modifying     anti-rheumatic drugs (DMARDs) in real world patients with RA. Using the date of dispensing as     the index date, the analysis will compute the time to first event for several cardiovascular     outcomes.   "
37258|NCT02797977|"     The study drug, SRA737, is a highly selective, orally bioavailable small molecule inhibitor     of checkpoint kinase 1 (Chk1). Chk1 is a serine-threonine kinase which acts as a central     regulator of the DNA Damage Response (DDR) network. The DDR is a complex series of pathways     which detect DNA damage, pause the cell cycle, and repair damaged DNA. Chk1 regulates     multiple cell-cycle phases, temporarily pausing the progression of cell replication and     division allowing DNA repair processes to be undertaken. In addition, Chk1 directly activates     several important downstream DDR proteins involved in the repair of damaged DNA.      In addition, Chk1 is believed to facilitate tumor cell resistance to chemotherapy-induced DNA     damage and, as such, the combination of SRA737 with DNA-damaging chemotherapies may provide     synergistic anti-tumor activity, consistent with findings in preclinical oncology models.      The purpose of this clinical study is to establish the safety profile, determine the maximum     tolerated dose (MTD) and to propose a recommended Phase 2 dose of SRA737 in combination with     gemcitabine. To determine potential patient selection strategies for further clinical     development, following MTD determination the study will also evaluate the preliminary     efficacy of SRA737 in combination with gemcitabine in prospectively-selected subjects with     tumors identified to have genetic aberrations hypothesized to confer sensitivity to Chk1     inhibition. Specific cancer indications that frequently harbor these genetic mutations will     be studied.   "
37260|NCT02797951|"     The main purpose of this study is to assess the long-term safety and tolerability of     galcanezumab administered up to once monthly in participants with episodic or chronic cluster     headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM     (NCT02438826).   "
37424|NCT02795793|"     This study is designed to determine the safety and efficacy of non-operative antibiotic     management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled     patients will be randomised and an allocation ratio of 1:1 will be made via weighted     minimisation, where half of the patients will receive non-operative management with     intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.   "
37261|NCT02797938|"     Endotracheal pressure with different cuff shapes can result in different cuff pressure change     after head positional change. In this study, 52 patients underwent middle ear surgery with     general anesthesia were randomly allocated to two group; patients were intubated with taper     guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with     sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22     centimeters of water in the neural head position and was measured after the change to the 45     degree head rotation. The change of cuff pressure was compared between two groups   "
37262|NCT02797925|"     There has been an increasing amount of musculoskeletal injuries the past decades and overused     tendons represents a major problem both for leisure and occupational activities. A full     understanding of the pathophysiology of tendinopathy is very sparse and especially the early     events in tendinopathy remains unexplained. In this phd study the investigators will     investigate early changes in tendon tissue overloading and development of tendinopathy. The     investigators will investigate sports-active individuals with recently developed tendinopathy     with regards to symptoms (pain, function), tendon morphology (ultrasonography, MRI and     electron microscopy), tendon mechanical properties (ultrasonography strain), tissue molecular     biology (expression and content of matrix proteins), inflammation (activity of inflammatory     pathways) and vascularization (Doppler and contrast enhancement US). The investigators     hypothesize a coupling between early symptoms and inflammatory activity, followed by     structural changes and altered mechanical properties. The investigation will indicate what     symptoms and what tendon related determined measurements are primary for disease development     (tendinopathy blue prints) and should be regarding vital in prevention of tendinopathy.   "
37263|NCT02797912|"     In patients with cystic fibrosis (CF) the commonest cause of death is respiratory failure.     Respiratory failure can have many causes. However, in patients with CF a major contributor is     the impairment of the muscles required for breathing (respiratory muscles). Respiratory     muscle impairment can result from poor nutrition. Lung function declines particularly during     adolescence whilst body composition also changes at the same time. Thus, the investigators     plan to study the relationship of nutrition and body composition to respiratory muscle     strength and lung function in children and young people with CF aged between 12-18 years. The     body mass index (BMI) is currently used in the clinical setting to measure nutritional status     in CF. At King's College Hospital (KCH) there are portable devices to assess both respiratory     muscle function and lung function. The research team will use a Bioelectrical Impedance     Analysis (BIA) device to assess body composition, including BMI and lean body mass (LBM). The     aim of the study is primarily to assess whether measurements of LBM impairment may better     relate to poor lung function compared to BMI and secondly to examine whether lung and     respiratory muscle function correlates with exercise tolerance.   "
37264|NCT02797899|"     Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This     prospective clinical trial was conducted aiming to determine whether the addition of an     autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and     decrease pain scores.      Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue     dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF     or not by a flip of a coin during the screening visit. Patients were instructed to complete a     pain study form. The palatal donor area were evaluated for complete wound healing records.     These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks     postoperatively.   "
37275|NCT02797756|"     Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be     performed, investigators will conduct a chart review to obtain relevant clinical data and the     investigators will use an aliquot of airway sample obtained during the clinically indicated     bronchoscopy for microbiome analysis. A case-control study design will be used to study     whether subjects with CC with GER have a distinct lung microbiome and increased inflammation     as compared with subjects with CC without GER and to determine whether the microbiome and     degree of inflammation is related to the type of GER (acidic versus nonacidic).   "
37276|NCT02797743|"     This study will obtain whole blood specimens from healthy subjects to be used for research     and development and clinical validation of genetic assays.   "
37265|NCT02797886|"     The goal of the study is to explore the effect of combined training involving functional     electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort     voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke     patients. Participants will be assessed for functional motor ability and neurological     function during their first visit and then again after five and then ten weeks of training.     Functional motor ability is broken down into dorsiflexion strength and general gait analysis.     Dorsiflexion strength is measured by use of a dynamometer. Gait is assessed via recordings of     electromyography, pedobarography, kinematic, and various functional variables during 10     walking trials. The neurological assessment will include electroencephalographic (EEG)     analysis of movement-related cortical potentials (MRCP), somatosensory evoked potentials     (SSEP), and M-wave response to stimulation. Participants will be randomly assigned to one of     three groups: 1) FES + volitional movement (VOL), 2) FES alone, and 3) VOL alone, which will     determine their training regimen. The training sessions involve roughly 20 minutes of     repeated muscle contractions (with appropriate breaks to avoid fatigue). The participants     assigned to the FES+VOL group will receive electrical stimulation to the peroneal nerve in     concert with volitional dorsiflexion, whereas the other groups will either dorsiflex     voluntarily with no stimulation or receive stimulation while being asked to do nothing.   "
37266|NCT02797873|"     The purpose of this study is to investigate how emotional and non-emotional regulation     processes differ in EIP patients (with different levels of ADHD symptoms/ADHD-comorbidity)     compared to controls. The investigators will test these participants' abilities to regulate     emotional and non-emotional processes, reward anticipation and reward receipt while they     undergo functional magnetic resonance imaging (fMRI). The participants' motor inhibition     capacity on a behavioral level will also be investigated.      The hypothesis is that EIP patients will present with more deficits in emotion regulation     processes compared to controls, even when controlling for ADHD symptoms. It is also     hypothesized that higher levels of ADHD symptoms will correlate with dysfunctional     non-emotional regulation processes, on a behavioral as well as brain mechanistic level.   "
37336|NCT02796950|"     Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine     stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used in     the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of GLP-1     are increased in response to acipimox. The hypothesis is that G protein coupled receptors on     enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion.      In a controlled, open, randomized experiment, eight healthy, overweight men will be studied     on an intervention day, where they receive acipimox, and on a control day. The study day     includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and a     biopsy from adipose tissue.   "
37267|NCT02797860|"     Pregnancy is associated with major changes of the body's physiological status and     composition.      These changes may modify the pharmacologic and/or pharmacokinetic profile of some drugs.     Pharmacodynamic and pharmacokinetic changes in the 1st trimester during pregnancy are     attributed to the following factors; Increase in plasma volume, heart rate and cardiac     output; decrease in blood pressure due to decrease of systemic resistance and relative     decrease of hepatic circulation and the aggravation of hepatic dysfunction. These changes     intensify as pregnancy progresses into the 3rd trimester and take their effect on the onset     time and duration of muscle relaxants.      Rocuronium and the steroidal non-depolarizing muscle relaxant like vecuronium is mostly     excreted with bile by hepatic metabolism and classified as the FDA pregnancy category B, and     is widely used in general anesthesia of pregnant women. Previous studies reported onset time     of rocuronium is affected by cardiac output, blood circulation time of the whole body, and     muscle perfusion. Accordingly, many researches were conducted under the assumption of onset     time and duration being affected by physiologic changes during pregnancy. For example, in the     research where vecuronium was used as muscle relaxant for pregnant woman undergoing C-sec,     onset of vecuronium was significantly shorter than that of the control group and duration was     longer. In a study investigating rocuronium used for patients right after delivery, onset     time was shorter and duration was longer than that of the control group.      However, previous research mostly focused on the 3rd trimester, while there have been only a     few studies of onset time and duration of rocuronium in non-obstetric surgery such as the     transabdominal cervicoisthmic cerclage (TCIC) or Mcdonald surgery which are performed under     general anesthesia during 2nd trimester. In this research, onset time and duration of     rocuronium, which is widely used for general anesthesia in 2nd trimester pregnant females,     will be compared with those of patients in the control group.   "
37268|NCT02797847|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of ALN-TTRSC02 in healthy subjects.   "
37269|NCT02797834|"     The main aim of this study is to describe the morphology, size distributions and specific     markers of the different vesicles populations present in the human endometrial fluid. To     further characterize the vesicles populations, contents of these membrane compartments (i.e.:     DNA, RNA, proteins, lipids and other small metabolites) will be assessed by using mass     spectrometry and next generation sequencing techniques. The objective here is to relate a     specific vesicles composition to the moment of the cycle, to a normal physiological     endometrial function and to the transmission of functionalities from the mother to the     embryo.   "
37270|NCT02797821|"     The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD)     of asfotase alfa in adult patients with pediatric-onset HPP.   "
37271|NCT02797808|"     The investigators will examine how treatment with sertraline for 12 weeks impacts     frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.   "
37272|NCT02797795|"     This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation trial     to be conducted in 2 sequential parts:        -  Part A (Dose Escalation) in subjects with advanced malignancies        -  Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results of          Part A   "
37273|NCT02797782|"     More than two billion individuals have serological evidence of hepatitis B virus (HBV)     infection worldwide. Of these, 240 million are chronic carriers and approximately 786,000     hepatitis B related deaths occur annually.      Currently available hepatitis B vaccines are extremely safe and have an efficacy of >90     percent against all HBV serotypes and genotypes. Thus, HBV infection can potentially be     eradicated through global vaccination. A positive immune response to the vaccine is defined     as the development of hepatitis B surface antibody (anti-HBs) at a titer of >10 mIU/mL.      Although anti-HBs titers decrease with time, the duration of protection is long. Protection     has been estimated to persist for up to 22 years after the primary vaccination schedule.     Protection from clinical disease, despite declining or even undetectable anti-HBs levels, is     probably due to the priming of memory cells, which are capable of eliciting an anamnestic     response when challenged. This is supported by the rapid increases in anti-HBs titers in     previously vaccinated individuals who administered booster injections.   "
37290|NCT02797548|"     The purpose of this study is to evaluate the safety and effectiveness of perioperative     antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.   "
37277|NCT02797730|"     Diagnostic of diabetes in childhood brought modification of family way of life, particularly     in child and caregivers lifes.      The education patient programs are in France centered on curative competencies of care.      It is possible that art-therapy improve psycho-social competencies The aim of the study is to     evaluate art-therapy sessions on quality of life of caregivers   "
37278|NCT02797717|"     Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical     Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy     intensification randomisation in intermediate and advanced classical Hodgkins lymphoma     patients to compensate for reduction in RT.   "
37279|NCT02797704|"     The goal of this current study is to prospectively evaluate the influence of a single     subconjunctival aflibercept injection on the regression of corneal neovascularization. Twenty     patients with corneal neovascularization who are candidates for anti VEGF treatment (by the     discretion of a corneal specialist) will be included in this study. The patients will be     treated with a single subconjunctival injection of 0.08 ml aflibercept (25 mg/ml) in a single     quarter of the conjunctiva, near the limbus in a proximity to the area of pathological     neovascularization. Regression of neovascularization will be documented.   "
37337|NCT02796937|"     This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled     GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data     for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin     deficiency.   "
37338|NCT02796924|"     The purpose of this study is to investigate the feasibility of using repetitive transcranial     magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the     frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES.   "
37280|NCT02797691|"     CBT for common mental disorders has a strong evidence base in both the USA and the UK. There     are wider cultural and linguistic differences between Non Pashtun and Pashtun population of     Pakistan and Afghanistan and there is evidence from research to suggest that CBT might need     some adaptations when working with clients from non-western background. This study, thus,     aims to culturally adapt CBT for common mental disorders for Pashto speaking population in     Pakistan and Afghanistan and to test the effectiveness of this adapted CBT through a small     scale pilot study.      The study will be carried out using mixed methods; quantitative and qualitative. Qualitative     part will consist of structured interview with a minimum of 10-15 patients; carers; and     mental health professionals, respectively, using the interview questionnaires. The data will     be analysed by systematic content and question analysis which will identify the emerging     themes and categories. The data will then be reorganized into wider themes and categories and     written for guidelines to culturally adapt therapy manual for common mental disorders.      Quantitative phase will be a RCT involving 40 patients (20 in each arm) to assess the     effectiveness of a CaCBT intervention for Pashto speaking patients. All those who fulfill     the diagnostic criteria of depressive episode or recurrent depressive disorder using ICD 10     RDC, are living near or can easily travel to the psychiatry departments in Peshawar, will be     included in the study.      The intervention group of the RCT will receive CaCBT intervention in addition to the     treatment as usual (TAU) while the control group receives TAU. The assessment will be carried     out at base-line and at the end of therapy (8-12 weeks). Bradford Somatic Inventory (BSI),     Hospital Anxiety and Depression Scale (HADS) and Brief Disability Questionnaire (BDQ)/ WHO     DAS will be used to measure somatic symptoms, anxiety, depression and disability due to     physical and psychological problems, respectively. Schwartz Outcome Scale will be used at     follow up to measure the outcome.   "
37281|NCT02797665|"     This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune     pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half     of participants will receive corticosteroids alone, while the other half will receive     corticosteroids with biliary stent at the beginning.   "
37282|NCT02797652|"     Our study aims to evaluate the possibility of clinical application of CTDNA detection in     samples or peripheral blood of breast cancer patients, so as to act as the new techniques or     indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast     cancer.   "
37283|NCT02797639|"     Objective: Developing and corroborating the Collaborative Consultation for Participation of     Students with Intellectual Disability (Co-PID) program, for enhancing classroom participation     among students with moderate Intellectual and Developmental Disability (IDD).      Method: study took place in two special education schools and included students with moderate     IDD (n=60) and their teachers (n=11). The settings were randomly assigned to intervention or     control group. In the intervention group, Co-PID program was employed; in the control group     an In-Service (IS) was employed. Participation was evaluated at pre-test and post-test.   "
37284|NCT02797626|"     Primary objective:      to evaluate progression-free survival in patients with clinical stage II A/B seminomatous     germ cell tumor undergoing primary retroperitoneal lymph node dissection (RPLND) without     adjuvant treatment      Secondary objectives:        -  overall survival        -  perioperative complications (Clavien-Dindo score)        -  quality of life (EORTC QLQ C30, EORTC QLQ TC26)        -  long term sequelae        -  rate of retrograde ejaculation   "
37285|NCT02797613|"     Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture     without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects     bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB     is difficult, since the microbiology laboratory cannot distinguish patients with AB. The     investigators study will use a restricted laboratory report requesting the physician to call     the laboratory for culture results. The restricted report may reduce the rate of     inappropriate treatment of AB.   "
37286|NCT02797600|"     The study hypothesis is that the increased incidence of cervical cancer observed in     Appalachian women over their non-Appalachian counterparts is due in part to inherited and     somatic alterations of key components of the Transforming Growth Factor β (TGFβ) signaling     pathway.   "
37287|NCT02797587|"     This study is a randomized controlled trial (RCT) to compare the effects of varenicline,     cytisine, and nicotine replacement therapy (NRT) to reduce: 1) alcohol use and craving, 2)     smoking; and 3) inflammation and risk for coronary heart disease (CHD) and mortality among     400 HIV-infected Russians, with heavy alcohol consumption and tobacco use.   "
37288|NCT02797574|"     The purpose of this study is to investigate stress response pathways in tissues and     melanocytes from patients with vitiligo. Investigators are collecting evidence of UPR and     stress response activation in tissues and melanocytes from patients with vitiligo.     Individuals with vitiligo will have punch biopsies to study stress response UPR activation     and NF-κB signaling to test our hypothesis. In order to characterize differences between     disease and normal states, a second arm of control individuals (Arm 2) will be recruited.   "
37289|NCT02797561|"     The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided     Percutaneous Coronary Intervention in coronary tandem lesions.   "
37291|NCT02797535|"     Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or     colostomy bags or having an ileal pouch and who meet the eligibility criteria will be     enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples     will be collected from: (i) fluids suctioned during standard endoscopy procedures /     pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from     stool samples collected by patients after pouch surgery.   "
37292|NCT02797522|"     Normal healthy volunteers (NHVs) will enroll sequentially into a total of 6 escalating dose     levels randomized to receive ARC-521 Injection or placebo.      Hepatitis B e Antigen (HBeAg) negative Chronic Hepatitis B patients (CHBs) will enroll     sequentially into a total of 3 dose levels to receive open-label ARC-521 Injection.   "
37293|NCT02797509|"     The current study has the following objectives:        1. To determine additional stroke patient (SP) and stroke caregiver (SC) factors including          their perceptions of the stroke experience, hospitalization, and how they cope with its          challenges; identify additional appropriate points to intervene (maladaptive coping          styles, unrealistic expectations, inappropriate prioritization, misinformation about          illness, and self care), and assess SP and SC preferences for the structure, mode of          delivery (including potential for phone, video or a combination of these) and timing of          an intervention.        2. To develop, [using the preliminary data and information from aim 1], and test the          feasibility and acceptability (primary outcomes) of a skills-based intervention for          preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.   "
37294|NCT02797496|"     Parkinson's disease is a major source of handicap, for which physical treatments are often     underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments     alone prove unable to stop or control the gradual worsening of motor disability after a few     years.      The training program that this study sets out to evaluate aims to restore balance between     agonist extensors and antagonist flexors in Parkinson's disease.      There is indeed in Parkinson's disease an imbalance between weak flexors and weaker     extensors, with excessive predominance of the flexors. The hypothesis of the study is that a     motor strengthening program targeting extensor muscles specifically will improve body posture     and restore motor function better than a conventional physical therapy program, in mild to     moderate Parkinson's disease.      This is a parallel-group, single blind, randomized trial (investigators will be kept unaware     of the physical treatment followed by study subjects).      The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up     following the intervention.   "
37295|NCT02797483|"     There is existing evidence to show that vegetable oils having unsaturated fatty acids in the     sn-2 position with predominantly palmitic acid (C16:0) or stearic acid (C18:0) in the sn-1     and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations     have come to be known as or explained by the sn-2 hypothesis. New evidence have also     emerged to show that saturated fatty acids (C16:0, C18:0) in the sn-1 and -3 positions     reduces fat deposition in a rat model. Therefore, further studies in humans are warranted to     confirm these earlier findings.      Fats and oils are made up of >90% triacylglycerol (TAG)- fat molecules which consist of a     glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid     attachment are referred to by stereospecific numbers, sn -1, -2 and -3. Early evidence shown     that the unique stereospecificity of fatty acid distribution on the palm fat molecule     conferred health benefits in that it inhibited experimental atherosclerosis in the rabbit     model.      In vegetable oils, oleic acid [a monounsaturated fatty acid (MUFA)] is predominantly situated     at the sn-2 position, while in animals fats it is predominantly palmitic acid or stearic acid     (C16:0 or C18:0-saturated fat) that is situated there. Even though palm olein and lard have     similar proportions of saturated fatty acid (SFA), MUFA and polyunsatuared fatty acid (PUFA),     they differ significantly in their positional distribution on the TAG molecule. Palm olein     TAG contains only 7-11 % palmitic acid at the sn-2 position while about 87% is unsaturated     fatty acids (oleic acid and linoleic acid). Lard has the highest amount of palmitic acid in     the sn-2 position at 70%. On the other hand, in human milk, palmitic acid is predominantly in     sn-2 (53-57 %) while cow milk fat contains less palmitic acid (38 %) there. It is now     believed that the distribution of fatty acids in the TAG is more important than the fatty     acid composition alone in conferring the oils' 'saturated' or 'unsaturated' properties.      In this proposed study, the effects on the outcome measures investigated of different fatty     acids (palmitic acid, oleic acid, linoleic acid) at the sn-1, sn-2 and sn-3 positions of the     TAG molecule in three different test fats will be investigated.   "
37296|NCT02797470|"     This phase I/II trial studies the side effects and best dose of gene therapy in treating     patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to     therapy or came back after an original response receiving stem cell transplant. In gene     therapy, small stretches of deoxyribonucleic acid (DNA) called anti-HIV genes are     introduced into the stem cells in the laboratory to make the gene therapy product used in     this study. The type of anti-HIV genes and therapy in this study may make the patient's     immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with     HIV-1.   "
37297|NCT02797457|"     The double amputation of the forearms is a rare handicap that seriously impacts the autonomy     and the quality of life of patients, social and familial exclusion, and dependence on third     parties for everyday activities.      The management of these patients is nearly exclusively through the use of prostheses. Certain     patients refuse this solution, or remain penalized by the absence of sensitivity , the lack     of precision in movements, and body image issues related to the amputation; the double graft     of hands and forearms may, in this circumstance, be the only solution.      Since January 2000, date of the first double hand graft, six bilateral grafts of hands have     been performed at the Hospices Civils de Lyon. This first study reported the feasibility of     the graft. The functional results obtained after the double transplant have allowed patients     to recover complete autonomy for everyday activities, at the price of an immunosuppressive     treatment. We have found that these very good functional results are maintained over time     and, for a certain number of patients, to return to work which is a factor of social     integration.      The rate of medical complications (metabolic, infectious, oncological), essentially related     to the immunosuppressive treatment, is not greater to that found for other types of graft,     but are considered as a limiting factor for the development of this strategy. These results     are confirmed by international experience that is of the same order. Only a few rare cases of     re-amputation have been reported in patients for whom the immunosuppressive treatment was     discontinued or following vascular thrombosis.      A new study is required to continue this evaluation and to compare double graft to prostheses     in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration.     The results of this study will allow the placement of these strategies in the management of     patients with double amputation of the hands and forearms.   "
37298|NCT02797444|"     Advance Care Planning (ACP) is a process of 'reflection and communication, in which a person     with decision-making capacity makes decisions regarding their future health and/or personal     care in the event that they become incapable of consenting to or refusing treatment' Most     Canadians have not planned for end-of-life Care and are at risk of aggressive medical care     that may not be compatible with their wishes. This study aims to systematically evaluate     local barriers to making personal choices with regards to life support interventions that can     be provided in the contemporary Intensive Care Unit.   "
37299|NCT02797431|"     A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies     of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in     sepsis patients; IRIS-7A (Immune Reconstitution of Immunosuppressed Sepsis patients).      A parallel study will be performed in United State of America to allow a common statistical     analysis of the primary end points and analysis for the enrolled patient population.   "
37300|NCT02797418|"     Holders children with intellectual disabilities have great difficulty in adapting to social     situations and relationships.Cognitive impairment associated with intellectual disability are     important factors to understand their difficulties in processing social information. In the     field of recognition of facial emotions in particular, basic cognitive processes such as     visuospatial and attentional functions, are heavily involved.Cognitive remediation is a     management tool widely used by practitioners to help patients who experience cognitive     difficulties. Currently, no program can meet specific and validated the problems are children     with intellectual disabilities manner in their daily functioning.   "
37301|NCT02797405|"     THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the     predictive value of the A & MS bioassays on tumor control by radiotherapy.   "
37339|NCT02796911|"     Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment     time. The current study will be carried to evaluate the effectiveness of different bone     grafts with a modified, less invasive corticotomy technique in the treatment of adult     patients with moderate crowding.      Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly     classified into three groups. Group I will be treated with a modified technique of     corticotomy, whereas group II will be treated with the same technique combined with PAOO     using bovine derived xenograft, and group III will be treated with the same technique     combined with PAOO using with bioactive glass. The total duration of active orthodontic     treatment will be estimated. Probing depth, bone density and root length will be also     evaluated. The measurements will be recorded.   "
37302|NCT02797392|"     The continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD     is a major health problem in developed countries and is mainly caused by an unhealthy     lifestyle. Most important lifestyle related causes of morbidity and mortality are smoking,     obesity and physical inactivity, and increasing rates of obesity and physical inactivity in     combination with smoking will lead to an increase in the number of patients with lifestyle     related diseases in the coming decades. There is, therefore, an urgent need to identify and     establish strategies and to implement interventions, allowing for the identification and     management of citizens at increased risk of disease.      Two recent systematic reviews of general practice based health checks suggest that people at     increased risk of a chronic disease may benefit from a targeted approach to health checks.     Targeted or selective preventive actions are a generally accepted and well integrated part of     the health care system (e.g. treatment of hypertension and hyperlipidemia). However,     selective prevention is challenged in terms of how to identify citizens at increased risk of     disease in the general population in order to start the indicated preventive actions.      The aim of the present pilot study is to test the acceptability, feasibility and short-term     effect of a selective preventive program that systematically helps citizens evaluate     individual risk of lifestyle related disease and offers targeted and coordinated preventive     services in the primary health care sector.      The intervention comprises four elements: 1) Systematic collection of information on     lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk     groups based on questionnaire data and information from the electronic patient record (EPR)     using validated risk estimation models, 3) An individual electronic health profile with     personalized advise on lifestyle change and 4) targeted preventive services at the general     practitioner (GP) or the municipality for citizens at risk of lifestyle disease and citizens     with risk behavior, respectively.      The intervention is supported by a patient-centered health information system that     facilitates informed patient action and integrates general practice and municipality health     care providers.   "
37303|NCT02797379|"     The purpose of this pilot intervention trial is to assess the efficacy of newly developed     psychoeducation guides designed to manage anxiety in Autism Spectrum Disorder (ASD) by     recruiting 30 participants with ASD and high levels of anxiety along with their     parent/caregivers who both receive a version of the psychoeducation guide.   "
37304|NCT02797366|"     Open label, multi-centre prospective study. Adult patients with primary central nervous     system tumours fulfilling the inclusion criteria according to the study protocol. The study     consists of 2 sequential cohorts evaluated consecutively for the feasibility, safety and     toxicity, as well as long-term survival data, when using spot scanning proton beam therapy.   "
37305|NCT02797353|"     The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a     dismal pictures and after the floods of 2010-2011 the health infrastructure of this district     was badly affected. Aga Khan University Pakistan is intending to implement a service delivery     project for the improvement of Maternal Neonatal and Child health situation through evidence     based MNCH interventions.   "
37306|NCT02797340|"     The study evaluates the pharmacokinetics of metformin in heart failure patients in acute and     chronic state in relation to metformin transporter genotypes. Participants have heart failure     and type 2 diabetes treated with metformin.      Hypothesis:      Primary: The renal clearance of metformin is decreased in acute state of congestive heart     failure compared with chronic state.      Secondary: Metformin trough values in HF patients are influenced by polymorphisms in     transporter genes relevant to the pharmacokinetics of metformin.   "
37307|NCT02797327|"     The primary goal of the study is to identify biomarkers from the molecular signature     predictive of pre-term birth. This will be achieved through high frequency sampling and     profiling throughout pregnancy.   "
37308|NCT02797314|"     Patients with type 2 diabetes have many complications in different organs. These     complications are extremely frequent and severe: cardiovascular and renal disease, visual     impairment, and, more recently, complications affecting bone such as fractures. Conventional     methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or     FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the     context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in     patients with type 2 diabetes compared to patients not suffering from this disease,     independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a     high BMD has led to the hypothesis that diabetes induces a modification of the quality and     not the quantity of bone. However, there is a lack of data as to bone quality in patients     with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are     extremely rare.      The objective of the study is to compare bone quality in patients with type 2 diabetes to     that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by     osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality     in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of     mineralization).      The results will then be correlated with blood/urinary markers with the objective to     determine one/several non-invasive biomarkers for bone status in diabetic patients.   "
37309|NCT02797301|"     This study was to develop a computerised test with an adapted peripheral to assess the     emerging literacy knowledge of children with mobility difficulties. The software was     implemented using a game-like design controllable by a peripheral device without needing fine     movements.   "
37862|NCT02790047|"     The aim of this study to investigate the efficacy of a home-base exercise program with a new     conical PEP device on physical performance and health related quality of life in COPD     patients.   "
37310|NCT02797288|"     The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by     identifying how Clostridium difficile toxins inhibit eosinophils that otherwise would protect     the gut from damage. This could lead to new and effective approaches to the treatment or     prevention of Clostridium difficile colitis that act downstream of fecal microbiota     transplants (FMT) or next generation probiotics. Successful fecal transplantation will     restore Interleukin-25, Interleukin-4 and eosinophils to the colon   "
37311|NCT02797275|"     Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in     nonsmokers. Flight attendants who worked on commercial aircraft before the ban on tobacco     smoking (exposed FAs) had high, long-term levels of occupational exposure to SHS and are a     unique population for the study of long-term health effects of chronic exposure to SHS.      In previous studies, we have shown that many never-smoking SHS-exposed FAs to have     curvilinear flow-volume loops, decreased airflow at mid- and low-lung volumes, and static air     trapping (elevated residual volume to total lung capacity ratio [RV/TLC]), abnormalities that     are not diagnostic of overt COPD, but do implicate the presence of an obstructive ventilatory     defect, and are consistent with what has been recently described as preserved ratio impaired     spirometry (PRISm).      The main objective of the study is to determine the effect of a bronchodilator to counter the     physiologic abnormalities that are observed in the population of never-smoking SHS-exposed     FAs as both proof of concept of the presence of an obstructive lung disease and as a possible     therapeutic option to counteract the adverse respiratory effects of chronic exposure to SHS.   "
37340|NCT02796898|"     The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88     in patients with prostate cancer   "
37312|NCT02797262|"     Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to     manageable disease but adherence to ART remains critical to optimize outcomes. Existing     measures of ART adherence provide only inferred measures of actual drug intake and most offer     no real-time notification capability. Directly observed therapy measures actual drug intake     but is not practical. These limitations constrain research into medication adherence and more     importantly, limit our ability to develop real-time interventions based on feasible, in vivo     monitoring of adherence among HIV-infected people to facilitate medication-taking. The     Proteus digital health feedback (PDHF) system, a pill ingestible sensor based adherence     measuring and monitoring system developed by Proteus Digital Health, addresses these     limitations. It involves use of an ingestible sensor, a tiny edible material that is     over-encapsulated along with prescribed medication. The sensor is activated by ingestion and     is sensed by a patch worn by the patient with an embedded monitor and sensor. The monitor     sends a Bluetooth signal to a mobile device, which in turn sends an encrypted message to a     central server, thus effecting real-time monitoring that a dose has been taken. The     investigators propose to develop a data receiving hub and add to these components an     automated text message that is sent to the patient when a dose is missed. The investigators     will evaluate the feasibility, acceptability and sustainability of using the PDHF system;     assess the accuracy of the PDHF system in measuring adherence to ART; and evaluate the     efficacy of the PDHF system for monitoring and leveraging adherence to ART.   "
37313|NCT02797249|"     Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over     the world. The use of low dose aspirin has been mentioned in several studies with promising     results. The investigators decided to evaluate the use of low dose aspirin in Chinese     pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical     characteristics aiming to reduce the incidence of preeclampsia.   "
37314|NCT02797236|"     This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose     escalation (two doses), placebo-controlled study in healthy volunteers.   "
37315|NCT02797223|"     The main objective of this qualitative phenomenological study is to understand the impact of     chemotherapy-induced alopecia, the quality of life of women with breast cancer from this     experience.      The study will be conducted in the day hospital oncology-hematology of the Hospital de la     Santa Creu i Sant Pau. Data collection will be done through semi-structured interviews. About     12 to 14 interviews throughout the study was conducted. So in the study involved a total of     between 12 and 14 women.      These will be recorded in voice and then transcribe and code. From reading and re-reading the     patterns or data that relate to each other, thus establishing the categories (thematic     analysis) were identified. These categories describe the experiences of the participants     alopecia.   "
37316|NCT02797210|"     This trial will compare the efficacy of active inhibitory OFC-rTMS to sham OFC-rTMS in major     depression. The trial will include structural and functional MRI, EEG, and behavioral     measures obtained before, during, and after treatment.   "
37317|NCT02797197|"     Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or     performance). There is a high prevalence in elderly and in patients with cancer. Several     mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal     disorders, lack of exercise, malnutrition). The consequences were analysed in several studies     where sarcopenia appeared to be an independent factor of mortality, and associated with     cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy     toxicities.      Diagnosis is based on the measure of the muscle mass performing an abdominal     computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip     test with a Jamar® hydraulic hand dynamometer. CT scan is more invasive and less easy to     reach than handgrip test. This test is used to be performing in elderly but not in cancer     patients having chemotherapy. Present prospective study explored the feasibility of     systematic handgrip strength testing and short-term changes in muscle strength in digestive     cancer patients treated by chemotherapy.   "
37329|NCT02797041|"     This observational, non-interventional, retrospective, multicenter, national study focuses on     collecting information about the effectiveness and safety of bortezomib re-use at first     relapse in MM patients already treated in their first line with a bortezomib-based regimen,     re-challenged with the same drug according to current clinical practice and/or Italian     SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations.      Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in     Italy. Approximately, data of up to 100 patients will be collected.   "
37330|NCT02797028|"     The purpose of this study is to confirm the protective effect and mechanism of anthocyanins     on hyperuricemia patients with Cardiovascular disease.   "
37318|NCT02797184|"     The purpose of this study is to do the work that is necessary and sufficient for setting up     an appropriate multi-center, randomized clinical trial (RCT) of a new therapy for heart     failure: inorganic nitrate. The investigators will first determine the effects and     palatability of ~12.8mmol KNO3 (an oral pill) as compared to the roughly equivalent amount of     nitrate in 2 beetroot juice (BRJ) Sports Shots (by James White Drinks). Next, the     investigators will determine the effects of inorganic nitrate (KNO3 in an oral pill format)     on blood pressure, blood nitrate levels, breath nitric oxide (NO) levels, and exercise     performance in a dose-response study. Third, the investigators will perform a small phase II     chronic treatment study that will allow them to determine the best primary endpoint and the     numbers of patients the investigators will need to study in the large, multi-center RCT to     follow this project. In the small study and in the RCT to follow, the investigators will     determine whether inorganic nitrate can improve aerobic exercise capacity, muscle power, and     speed of muscle contraction, and lessen the effort of breathing during exercise.   "
37319|NCT02797171|"     This study will evaluate the safety, pharmacokinetics, and antiviral activity of     VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of     healthy, HIV-uninfected adults.   "
37320|NCT02797158|"     Evaluation of a strategy of selected revascularization guided on myocardial ischemia     detection after the TAVI procedure by using single photon emission computed tomography     (SPECT) myocardial perfusion imaging.   "
37341|NCT02796885|"     Hypophosphatasia (HPP) is an inherited condition which causes a defect in bone calcification,     leading to weak bones. Early childhood forms are severe and easily recognised, and there is     now a drug treatment which is very effective in children.      Adult forms are milder, often missed by doctors or confused with osteoporosis. This is     important because the usual osteoporosis treatments may be harmful in HPP, and increase the     risk of broken bones. One of the reasons it is missed is a lack of research describing the     typical features of HPP, so doctors don't recognise the signs, and don't know when or how to     test for it.      The aim of this study is to establish clear criteria (from clinical history, examination and     blood tests) to identify people with HPP. The results will also determine if there should be     a trial of drug treatment for adults with HPP.   "
37321|NCT02797145|"     Digoxin was approved for heart failure treatment in 1998 according to current regulations     made by Food and Drug Administration (FDA), based on the following clinical trials: The     Prospective and Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED),     Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme     (RADIANCE) and Digitalis Investigation Group (DIG). Also, it was approved for the control of     ventricular response rate in atrial fibrillation patients.      Several clinical trials with digoxin provided convincing evidence that support the digoxin     use heart failure (HF) treatment of symptomatic patients. PROVED trial was a     placebo-controlled, twelve weeks duration study. This study included patients with decreased     systolic function, sinus rhythm and heart failure stable symptoms, these patients were using     digoxin and diuretics. Patients whom digoxin was removed presented a twice heart failure     worsen, reduction of exercise capacity and also a reduction of left ventricle ejection     fraction, in comparison to patients that kept the digoxin therapy. The study RADIANCE     followed a similar protocol; however the patients used ACE inhibitors besides digoxin and     diuretics. The digoxin removal was associated with a six times worsen of heart failure,     despite the maintenance of ACE inhibitors and diuretics. There was a worsening in the     functional capacity, life quality and in the ejection fraction on the digoxin removal     patients' group.   "
37322|NCT02797132|"     This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the     pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of     Lumacaftor/Ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with Cystic     Fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in     Part B, if patient meet the eligibility criteria.   "
37323|NCT02797119|"     TRACES trial is a multicenter randomized double blind placebo control therapeutic and     pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a     single intravenous infusion of two doses regimens (standard dose and low dose) of TA     administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to     correlate this clinical effect with the biological effect of fibrinolysis inhibition and the     pharmacodynamic measure of TA uterine bleeding and venous blood concentration.   "
37324|NCT02797106|"     The study is a transversal, observational, descriptive survey of the practices and opinions     of health professionals carried out nationally across France that aims to characterize     children with cerebral palsy and pathological drooling and to describe care pathways,     assessment and treatment of drooling.   "
37325|NCT02797093|"     The purpose of this study is to evaluate the relationship between anti-retroviral therapy     (ART) adherence with levels of human immunodeficiency virus (HIV) reservoir and residual     viremia in suppressed, HIV-infected individuals on chronic ART.   "
37326|NCT02797080|"     The purpose of this long term extension study is to evaluate the long-term safety of     ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).   "
37327|NCT02797067|"     The purpose of the study is to determine whether rectal indomethacin reduces the incidence of     post-ESWL pancreatitis.   "
37328|NCT02797054|"     The purpose of this study is to evaluate an innovative approach to improving HPV vaccination     among the Hispanic population. The objectives/aims of this HPV educational intervention     project are:        1. To measure the quality of the HPV vaccine decision among participants in different arms          of the intervention        2. To determine patterns of intervention utilization among participants in different arms          of the intervention, and      The implementation of this educational intervention in clinic waiting rooms is intended to     assist primary care providers in communicating HPV vaccine awareness and education to parents     and patients in a culturally tailored format.   "
37331|NCT02797015|"     The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of     RPC1063 in RMS.   "
37511|NCT02794636|"     The primary objective of this study is to quantify and compare the prevalence of adverse     events (AEs) in patients with stage III melanoma before and after initiation of interferon     (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and     resource utilization before and after IFN initiation among patients with stage III melanoma     in a real-world setting.   "
37332|NCT02797002|"     Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's     societies. Cervical muscles endurance has been commonly associated with the development of     NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical     therapists to evaluate muscle structure, function and activation patterns. The aim of this     study is if change in muscle thickness can correlate with the results of the endurance     testing.   "
37333|NCT02796989|"     During this project the effect of modified wheat bran on colon health and systemic health     will be evaluated in a long-term intervention study in healthy and obese subjects.   "
37334|NCT02796976|"     The aims of the study are twofold. In the cross-sectional approach (Part I), the study will     be conducted in an older population to assess the association of physical fitness on     different parts of the human vascular bed. In the interventional approach (Part II), it aims     to investigate whether and to what extent advanced vascular ageing (AVA) in older subjects     with increased cardiovascular risk can be reversed by regular walking- based high intensity     interval training.   "
37335|NCT02796963|"     The purpose of this stepped wedge randomized controlled trial is to evaluate the     effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men     who have sex with men (MSM). The crowdsourced intervention will include an open contest,     judging to determine finalists and prizes, a designathon, and contest-based MSM engagement.     The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test     uptake campaigns in eliciting HIV test uptake.   "
37342|NCT02796872|"     This survey is a multicenter, double-blind, randomized, controlled, parallel-designed,     prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance,     gut health, fecal flora and immune function.   "
37343|NCT02796859|"     This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy of     Siltuximab (Sylvant) as an adjunct to antipsychotic medications in stable outpatients with     schizophrenia. Siltuximab (structural formula C6450H9932N1688O2016S50) is a recombinant     chimeric (human-murine) anti-human interleukin-6 (IL-6) monoclonal antibody. Siltuximab is     formulated as a concentrate for solution for infusion, and will be administered by     intravenous infusion.      The investigators propose a 9-week randomized controlled trial of siltuximab, given in     adjunct to antipsychotics, in N=30 stable outpatients with schizophrenia or schizoaffective     disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity     C-reactive protein [hsCRP] >0.5 mg/dL). The investigators hypothesize that adjunctive     treatment with siltuximab will be associated with significant improvement in cognition     compared to placebo in patients with schizophrenia, baseline IL-6 levels are higher in     siltuximab-treated responders versus non-responders, and there will be greater decreases in     hsCRP from baseline to week 6 in siltuximab-treated versus placebo-treated responders, with     response defined as ≥0.5 SD improvement in cognition. Siltuximab is administered as an     intravenous infusion every 3 weeks. Following a screening evaluation, participants will     receive three infusions of siltuximab, one at baseline, another at week 3 of the study, and     another at week 6. The investigators will measure changes in cognitive function and symptoms     over a 9-week period. Complementing previous positive clinical trials of non-steroidal     anti-inflammatory drugs, this would be a proof-of-concept study that targeting specific     cytokines is a viable treatment for schizophrenia.      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by     Tadamitsu Kishimoto in the 1980s. Janssen Pharmaceuticals, Inc. began the clinical     development of siltuximab for the treatment of multicentric Castleman's disease, a rare blood     disorder. Other clinical studies with siltuximab have been conduced for patients with B-cell     non-Hodgkin's lymphoma, multiple myeloma, and ovarian cancer.      In April 2014,siltuxiumab was approved by the U.S. Food and Drug Administration (US FDA) as     Sylvant for human immunodeficiency virus (HIV)-negative and human herpesvirus-8     (HHV-8)-negative multicentric Castleman's disease.   "
37344|NCT02796846|"     The purpose of this study is to evaluate the pre and postoperative CPAP compliance rate in     OSA surgical patients with or without a CPAP prescription. In this study, all diagnosed OSA     patients with or without a CPAP prescription will be approached for informed consent to     enroll in the study. Documented OSA is defined as an OSA diagnosis based on a previous     laboratory or portable PSG, or on the prescription of CPAP for OSA. The patients with a CPAP     prescription will be followed up to determine their compliance with CPAP and data will be     collected to determine the O2 saturation. Those patients with diagnosed obstructive sleep     apnea without a CPAP prescription will also be followed to objectively determine the severity     of OSA which would indicate whether they do not require CPAP owing to their mild OSA or they     in fact may require CPAP due to change in weight etc. Preoperative overnight oximetry will be     performed on all the OSA patients at home before surgery. In the postoperative period, all     patients will be followed up with a nocturnal oximetry in the first two post-operative nights     of hospital stay. Postoperative compliance to CPAP will be evaluated and recorded in all the     patients. The patients' charts will be reviewed for any postoperative complications. The     clinical management of patient will be left to the discretion of the perioperative care team.   "
37345|NCT02796833|"     Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required     when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates,     protein, and fat and lipids. It also contains minerals and vitamins. The lipid that is     currently used at the University Health Network home TPN program is Intralipid20%, which is     based on Soybean oil, contains polyunsaturated fats and is a good source of energy and     essential fatty acids, including omega 3 and 6 fatty acids, which needed by the body.     However, long term use on Intralipid20% has been shown to have negative effects on     antioxidant status, inflammation, liver, and the immune system.      SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to     omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with     Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has     positive benefits on the liver enzymes. There are no studies so far which follow patient who     is on SMOFlipid20% long term. The investigators hope to show that with long term use of     SMOFlipid20% is better for liver function compared to Intralipid20%.   "
37346|NCT02796820|"     A randomized, paralleled control clinical study investigating Huaier Granule for prevention     of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the     efficacy and safety.   "
37366|NCT02796560|"     The purpose of this study is to compare the efficacy and tolerance of generic travoprost with     its brand name formulation. In this open label, randomized, crossover study, the primary     outcome will be intraocular pressure and the secondary outcome will be tolerance to the     drops, as measured by a subjective questionnaire. Patients will be randomized to receive     either brand name or generic travoprost during the first visit. At the second visit 3 weeks     later, their intraocular pressure will be measured and a questionnaire will be completed on     the tolerance of the medication. Patients will then receive the other formulation of     travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure     will be measured and a questionnaire will be completed on the tolerance of the second     medication.   "
37347|NCT02796807|"     Prostate cancer is the second leading cause of cancer death in North American men older than     50 years. Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein,     which is overexpressed manifold on prostate cancer cells and is well-characterized as an     imaging biomarker of prostate cancer. Positron emission tomography / computer tomography     (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from     radiolabeled tracer molecules. 68Ga-HBED-CC-PSMA (DKFZ-11) (abbreviated 68Ga-PSMA) is a     tracer for prostate cancer PET imaging. The strength of functional imaging methods is in     distinguishing tissues according to metabolism rather than structure. Studies have shown that     PET/CT imaging with 68Ga-PSMA can detect prostate cancer lesions with excellent contrast and     a high detection rate even when the level of prostate specific antigen is low.      Study Objectives:      The objective of this study is to evaluate if the patient-wide SUVmax on 68Ga-PSMA PET/CT in     locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at     initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.     This is of interest because non-invasive risk stratification may be possible in the future.      This will be a single-site JGH-only open label study in which one (1) 68Ga-PSMA PET/CT will     be performed on study participants. A PET/CT scan takes 2-3 hours.   "
37348|NCT02796794|"     To evaluate effects of genistein supplementation to enteral nutrition on inflammatory     cytokines and morbidity in patients with sepsis   "
37349|NCT02796781|"     Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The     lung scarring that occurs in ILD is often irreversible with only mitigating therapy available     so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to     investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment,     lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After     careful characterization, cultured cells will be injected directly into the lesion by     fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by     measuring the key clinical indicators.   "
37350|NCT02796768|"     Ultrasound imaging (US), a radiation-free imaging modality, is currently used in diagnosis of     developmental dysplasia of the hip (DDH) in infants. The current protocol involves manually     identifying specific measures that are prone to error, and may give rise to false positives.     We aim to use 2-dimensional (2D) and 3-dimensional (3D) ultrasound imaging to create an     automatic measurement procedure that we hope will reduce the errors in measurement and     increase reliability.   "
37351|NCT02796755|"     The goal of the proposed research is to determine whether riluzole, a drug that increases     glutamate reuptake, will decrease CNS glutamate in breast cancer survivors with increased     inflammation and fatigue. We will also determine whether decreasing glutamate with riluzole     will reverse inflammation-related fatigue and other symptoms including cognitive dysfunction     and decreased motivation. To accomplish these goals, we plan to conduct an 8 week,     double-blind, randomized control trial of riluzole (100 mg/d) versus placebo in 40 breast     cancer survivors (n=20 per group). All breast cancer survivors will have completed treatment     within 1-3 years and have a fatigue level of ≥4 (on a 10 point scale) and a plasma c-reactive     protein (CRP) concentration >3mg/L (indicative of high inflammation). Patients will undergo     magnetic resonance spectroscopy (MRS) to measure CNS glutamate before and after 2 and 8 weeks     of riluzole or placebo treatment. Fatigue and other behavioral assessments including measures     of cognitive function and motivation will be conducted before and after treatment and     correlated with the change in CNS glutamate.   "
37352|NCT02796742|"     Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative     pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and soft     tissue infections (SSTIs) is known to be due to the spread of the USA300 clone [Moran et al.     2006]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of MRSA in     SSTIs and the causative genotypes remain scarce. The paucity of literature on the prevalence     of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably due to the     fact that culture and antimicrobial susceptibility testing is not a routine component of SSTI     management.      Setting-up a prospective multi-centre study involving patients presenting to emergency     departments with SSTIs in several European countries would allow drawing a picture on the     role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a     cause of SSTIs. However, the roles of emergency rooms and local policies with regard to     performing microbiological analysis after surgical drainage of SSTIs vary between countries.      In order to evaluate the feasibility of such multicenter European study, we aim at performing     a pilot study based on few European clinical laboratories (five to seven) which will: i)     evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in     community-acquired SSTIs; and ii) determine molecular characteristics of the isolated     strains. The main objectives of this pilot study are to collect some preliminary information     on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or     taken into consideration for the set-up a larger prospective cross-sectional study involving     more European countries with several centers per country to cover different geographical     areas per country.   "
37353|NCT02796729|"     This project will compare two MRI contrast agents in metastatic brain tumours in humans. More     specifically, the investigators will compare the tumour contrast obtained using glucose     versus the current standard gadolinium-based contrast agent (GBCA, gadobutrol, trade name     Gadovist, will be used).      First, participants will receive a glucose bolus injection followed by glucose enhanced MRI.     Second, participants will receive a Gd-DTPA bolus injection followed by Gd-DTPA enhanced MRI.     Both contrast studies will be performed during the same MRI study, which will be under one     hour long.   "
37395|NCT02796183|"     This study evaluates the effects of subconjunctivally injected bevacizumab in patients with     diffuse diabetic macular edema.   "
37396|NCT02796170|"     To assess the effect of SGLT-2 inhibitors on blood pressure and urinary angiotensinogen. This     is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks     followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6     weeks. In addition there will be an arm of 10 subjects who will receive sulfonylurea in an     open label as a comparative to the cross over subjects to assess if the effect of     Dapagliflozin may also be in part due to improved glycemic control.   "
37863|NCT02790034|"     This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing     respiratory abnormalities in Rett Syndrome.   "
37354|NCT02796716|"     This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that     uses a digital microscope to identify bacteria based on their growth patterns. This method     does not have to wait for bacteria to grow in a lab. The new method can identify the type of     bacteria within 2 hours of receiving a specimen. The new method also shows the effect of     selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors     know within 6 hours from specimen collection which antibiotic kills the bacteria.      To check the accuracy, speed and impact of the new method on antibiotic prescribing,     investigators are proposing a study with two parts; The first part will test the accuracy and     speed of the results obtained by the new method. The second part will test if having the     results from the new method early would change the antibiotics prescribed to a patient in a     simulation experiment. An independent infectious disease physician will be shown the results     from the new method and asked if the results were accurate, would it change the antibiotic     treatment for the patient.   "
37355|NCT02796703|"     Prophylactic probiotics have been shown to decrease the incidence of Necrotizing     Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live     bacteria to small babies. Based on animal data, the investigators hypothesized that heat     inactivated probiotics would also reduce NEC.   "
37356|NCT02796690|"     The repeated exposition to S. aureus is considered as a determining factor of acquisition of     the nasal colonization. The healthcare professionals are regularly in touch with this     pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was     the object of several studies but little took into account the respect for the rules of good     hygienic practice. The results of our previous study carried out during the international     congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between     the work in a hospital environment and the increase of the risk of nasal carriage. On the     contrary, the use of the hydro-alcoholic solutions had a protective effect against this     carriage. However, sized of the health care population of our study was limited.      The goal of this study is to confirm our previous results on a larger cohort of healthcare     professionals. The main objective is to estimate the prevalence of nasal carriage according     to the professional category and by taking into account the degree of conformity with good     hygiene practices including the use of hydro-alcoholic solutions.   "
37357|NCT02796677|"     This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and     multinational Phase III study to determine the efficacy and safety of Aclidinium bromide     400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO     (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary     disease (COPD).   "
37358|NCT02796664|"     The purpose of this study is to determine whether Ginseng is effective in the prevention of     atherosclerosis and subsequent ischemic stroke.   "
37359|NCT02796651|"     To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg)     twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized     formoterol fumarate (20 μg and 40 μg).   "
37360|NCT02796638|"     The primary hypothesis of this study is: the use of minute ventilation-adaptive     servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal     function and prevent kidney injury in patients admitted with acute heart failure (AHF)     compared to those receiving usual care. We will validate and extend our pilot study by taking     a deeper dive into the effects of ASV on diuretic dose, urine output and new and exciting     biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly     suggests that ASV lessens injury to the kidney and could lead to a new paradigm for the     treatment of AHF. When use of high dose of diuretics are anticipated or in whom chronic     kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the Emergency     Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued     use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective     glomerular filtration. Since kidney injury is a major factor in those patients with early     30-day readmission following discharge, this therapy could become quite popular.   "
37361|NCT02796625|"     The investigators will use non-invasive recordings of brain activity to measure pain as a     proxy to self-report. Participants will undergo testing for about 3 hours on two separate     days. The testing will involve experiencing painful heat.   "
37362|NCT02796612|"     The project investigates prospectively whether anxiety in the context of breast biopsy can be     reduced by the planed intervention (take-home brochure and structured and standardized     information given by a psychologically trained physician who performs the biopsy).   "
37363|NCT02796599|"     The purpose of this study is to determine wether the interface (facial or nasal mask)     influences performance in patients with chronic obstructive pulmonary disease exercising with     non-invasive ventilation.   "
37364|NCT02796586|"     To evaluate the feasibility and effectiveness of group contraceptive counseling on family     planning knowledge acquisition, service satisfaction, method uptake and continuation among a     group of resettled African refugee women.   "
37365|NCT02796573|"     Depression is a prevalent and disabling disorder with great cost to the individual and the     society. Lately, the use of internet interventions as guided self-help has demonstrated     remarkable results. However, certain shortcomings such as lack of personal adaptation has     been identified.      The presents study aims to investigate the potential of blending Internet based interventions     with face-to-face consultations using cognitive behavioural therapy (B-CBT). The main     hypotheses are, that that B-CBT will be as clinically effective as TAU, and that it will be     acceptable to patients and clinicians.      The study is designed as a two arm randomised non-inferiority trial comparing internet based     B-CBT for depression to treatment as usual (TAU) defined as 12 sessions of face-to-face CBT.   "
37397|NCT02796157|"     PCI of diffuse long coronary lesions still remains challenging because of relatively high     risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The     purpose of the study is to compare an incidence of composite of major adverse cardiovascular     events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary     intervention in long lesions.   "
39327|NCT02770859|"     POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less     (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical     alternative to release the muscle & sphincter of the LES for the treatment of achalasia.   "
37367|NCT02796547|"     An episiotomy is an incision of the perineum to facilitate childbirth by natural means.     Perineal pain are more frequent and intense if the incision of the perineum is important. In     particular, simple vaginal or perineal tears are less painful than episiotomies in the first     seven days postpartum, whereas at six weeks postpartum, there is no significant difference     anymore.The patients are the most symptomatic in the immediate postnatal period, but the pain     may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often     undervalued and may interfere with the mother-child bond in the absence of an effective     treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal     anti-inflammatory drugs given orally or rectally and paracetamol.      The scar infiltration is one of the components of a multimodal postoperative analgesia     strategy. It consists in the simultaneous use of several drugs or analgesic techniques,     acting on different pain components in order to improve the overall efficiency.The most used     local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine.Ropivacaine has     a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the     injection point and a blood resorption that is more spread. The systemic toxicity threshold     is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects,     and an intermediate systemic toxicity threshold intermediate between bupivacaine and     ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in complement     infiltrations when a rapid onset of action is desired.      So far, there is no data in the literature regarding the effect of levobupivacaine in     episiotomies associated pain. The objective of this study is to evaluate the effect of local     injections of levobupivacaine on episiotomies associated pain.   "
37368|NCT02796534|"     Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular     or neuropathic complications; in addition to an optimal treatment, prevention of diabetes     complications requires to control associated risk factors, such as hypertension or     dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and     marked morbidity and mortality, one increasingly interesting aspect is its relationship with     metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be     underestimated in this population. In this context, it appears to be important to estimate     the prevalence of sleep respiratory diseases in patients with type 1 diabetes.   "
37369|NCT02796521|"     At hospital, short term actions are used (adaptation of meals, oral supplementation…) to     fight malnutrition. Oral supplementation can have a positive impact on weight gain. But     actions should continue at home, particularly to maintain autonomy for elderly. The     hypothesis is that practical workshop about enrichment and interest of foods can help     malnourished patients to change their eating habits. The main goal of this study is to     evaluate the effects of this workshop on improving nutritional status, measured by Mini     Nutritional Assessment   "
37376|NCT02796430|"     This study will evaluate the ease of use of the new calorimeter (Quark RMR 2.0 (COSMED,     Italy)) in intensive care unit (ICU) patients compared to currently used calorimeters (i.e.     Quark RMR 1.0(COSMED, Italy) or Deltatrac Metabolic Monitor (Datex, Finland)), as well as the     stability and the feasibility of the measurements in various clinically relevant situations.      Time needed to prepare and start indirect calorimetry (IC) measurement will be compared as     the measure of the ease of use of the calorimeter.   "
37377|NCT02796417|"     This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to     improve cognition, social cognition, clinical symptoms and functional outcome in patients     with schizophrenia.   "
37370|NCT02796508|"     Neuroplasticity-based approaches seem very promising to maintain cognitive health in older     adults and postpone the onset of cognitive-decline and dementia symptoms. The aims of this     project are threefold:        1. the evaluation of the effects of a neuroplasticity-based-cognitive randomized          computer-based intervention consisting in training with non-action video games on brain          and cognitive functions that decline with ageing, including attention and spatial          working memory (WM), in older adults using behavioral measures and electrophysiological          recordings (event-related potentials -ERPs- and event-related spectral perturbations          -ERSPs);        2. the study of the effects of age and 3 months maintenance on the cognitive and neural          signatures of transfer effects to attentional and spatial WM tasks; and        3. to investigate the neuroinflammatory mechanisms assessed by non-invasive methods in          saliva from participants underlying cognitive training-induced effects.      A better understanding of these mechanisms elucidates pathways that may be targeted in the     future, either by behavioral or neuropsychological interventions. To achieve these aims, the     investigators will recruit between 60-80 older adults volunteers to participate in the     randomized, controlled, single-blind study. After screening, participants will be randomly     distributed in one of these two groups: experimental and active control. Participants in the     experimental group will receive 16 1 hour computerized training with non-action video games.     The active control group will receive 16 1 hour training sessions with a social video game.     The design is a mixed factorial design with type of intervention (experimental, active     control) and assessment session (pre, post, maintenance). The results from the proposed     research project will clarify the existence of transfer-of-benefit and neural mechanisms     underlying cognitive improvement. The hypothesis is that mental stimulation through     non-action video games will improve attention and memory, promoting brain and mental health,     and extending independence among elderly people by avoiding the negative personal and     economic consequences of long-term care.   "
37371|NCT02796495|"     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously     difficult to treat. Amputation usually follows traumatic injuries or surgery following     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is     required for the survival of the patient. The loss of a limb or other body parts is usually     followed by the sensation that the lost body part is still present and can be felt. These     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure     on the residual limb) and psychological factors (e.g. emotional stress). It is well known     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,     psychological and other, are ineffective.      Today it is believed that phantom limb pain may be related to changes in the cortex of the     brain. There is evidence that these changes may be modulated - or even reversed - by     providing sensory input to the stump or amputation zone. For example, cortical reorganization     and alleviation of phantom limb pain has been observed in amputees following intense use of a     hand prosthesis. However, there is no consistent knowledge on which type of peripheral     sensory feedback may be effective in affecting the cortical plasticity or on how to best     apply the sensory feedback.      The aim of the proposed research is to create natural, meaningful sensations through     providing invasive sensory feedback (i.e. electrical stimulation through intraneural     implantation of electrodes) and the effectiveness to alleviate phantom limb pain and restore     the cortical neuroplastic changes.   "
37372|NCT02796482|"     This open-label, prospective, controlled intervention study involves evaluating tolerance and     acceptability of an Oral Nutrition Supplement (ONS; EnergieShake® 1.5 kcal Complete drink) in     18 adult patients who are already taking an ONS. Following a 2-day baseline data collection     on their current ONS, patients switch to the test ONS, which is taken for a further 8     consecutive days. Patients revert to their current ONS at the end of the study. Patients act     as their own controls and thus all patients are allocated the same intervention.      Daily records of GI tolerance and compliance with the prescribed amount of ONS will be kept     for participants throughout the study period. Participants' height and weight will be     collected at baseline (weight at end will also be collected), all medications will be     documented, and relevant medical and dietary histories will be recorded. A questionnaire at     the end of the intervention period will be administered collecting participants' views on the     acceptability (taste and palatability) of the test ONS. Taste and palatability will be     assessed via a questionnaire that uses a Hedonic scale to quantify preference.   "
37373|NCT02796469|"     In the specific setting of the evaluation of corticosteroids, pentoxifylline of their     combination in severe alcoholic hepatitis, only meta-analysis combining individual data is     able to provide detailed information from each individual with severe alcoholic hepatitis     assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both     univariate and multivariate analyses, truth survival is lower for conclusions from     meta-analysis of the literature than for conclusions derived from non-meta-analyses.      The present study is a meta-analysis of individual data from RCTs restricted to patients with     a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving     either corticosteroids, or pentoxifylline or their combination to those of patients not     receiving them adjusted on the independent prognostic factors at baseline.      The secondary endpoints will be: a) assessment of response to the assigned treatment using     the Lille model; b) analysis of 6-month survival according to allocated therapy.   "
37374|NCT02796456|"     Background :      Apelin and its receptor APJ have been implicated in pathologies including cardiovascular     disease, diabetes and obesity. Little is known about the function of the apelinergic system     during gestation.      Objective :      The main objective of this study is to compare apelinemia in fasting normal weight and obese     women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).      Strategy and method:      A prospective research evaluating will be conducted to compare apelinemia in fasting normal     weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).      A third group will be created to check if gestational diabetes is not a confounding factor in     obesity (group of obese women with gestational diabetes).      Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.      Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and     to see if neonatal apelinemia is correlated to the child's weight and birth size and to the     weight of the placenta.      Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.      Two days after delivery, obese and not obese women will be fasted and plasma and colostrum     will be collected. Investigators will compare apelin levels in the colostrum between these 2     groups and then investigators will try to see if apelin level is correlated in the colostrum     and in maternal plasma.   "
37375|NCT02796443|"     Meta-analysis of randomized controlled trials and population based studies in acute     cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several     weeks later. The main problems in these studies are the exclusion criteria used, thus not     reflecting the real world setting of acute cholecystitis. The purpose of this study is to     demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse     outcome in comparison with an early operation (within 72 hours after onset of symptoms).   "
37378|NCT02796404|"     The current state of mobile communication and technology is a tool to support home programs     for chronic disease management, useful to facilitate access to these types of programs,     because the investigators could obtain telematics information about the parameters, reducing     cardiovascular risk factors and cardiovascular morbidity and mortality.   "
37380|NCT02796378|"     Background. Statins are cholesterol lowering drugs that are prescribed to lower the risk of     cardio-vascular diseases. The use of statins has increased markedly and it is now one of the     most prescribed drugs in the world. More than 600,000 people in Denmark are taking statins on     a daily basis, approximately 40 % of these are taking the medication without having any other     risk factors for cardio-vascular diseases than elevated blood-cholesterol i.e. they are in     primary prevention.      Statins are not without side effects and studies have shown that there is an elevated risk of     developing diabetes when taking statins. This has led to an increased debate about the use of     statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent     one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5 years.     These data suggest that more conservative use of statins to prevent CVD in otherwise healthy     individuals at low risk for future CVD may be warranted.      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially     can prevent a physically active lifestyle. The biomedical background of these side effects is     not fully elucidated but it has been shown that there is a link to decreasing levels of an     important enzyme, Q10, which plays a role in muscle energy metabolism.      Hypothesis      The overarching research question is: why does statin treatment cause muscle pain? Does     statin treatment impair (or even prohibit) physical exercise training? Furthermore the     following questions will be investigated:      A. Does statin treatment cause:        1. Decreased muscle strength?        2. Skeletal muscle inflammation?        3. Decreased mitochondrial respiratory function? B. Abnormal glucose homeostasis?      Re question A & B: If so, can physical training counteract this effect of statin treatment?   "
37381|NCT02796365|"     The purpose of this study is to identify patients at risk for future heart failure using     novel markers of early cardiac damage and determine if exercise training can improve these     emerging markers as well as overall fitness and quality of life.   "
37382|NCT02796352|"     This study is for patients with advanced stage III or stage IV melanoma not adequately     treated by surgery who have progressed after treatment with nivolumab or pembrolizumab. The     purpose of this study is to see if giving high dose interleukin-2 (IL-2) after progression on     nivolumab or pembrolizumab is effective in treating metastatic melanoma. This study is also     being done to look at the severity of side effects of IL-2 in patients.      IL-2 is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced     melanoma.   "
37384|NCT02796326|"     The purpose of the study is to prospectively assess the use of a modified tracheal balloon     dilator that allows gas flow (oxygenation and ventilation) through the device while inflated     during dilatation.   "
37385|NCT02796313|"     We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension)     based intervention in 400 adult American Indians with inadequately controlled systolic blood     pressure (≥140 mmHg). Over the 5 years of the project, we will recruit and randomize 200     participants from each of 2 urban sites in Washington and Oklahoma.      In addition, we will conduct a pilot study after the 8 week intervention concludes to test     whether providing 6 additional week of dietitian support (without the grocery supplement) can     help improve blood pressure over the long term.   "
37420|NCT02795845|"     During pregnancy, bacterial vaginosis (BV), abnormal vaginal flora (AVF) and vulvovaginal     candidiasis (VVC) are associated with serious complications and discomfort. Yet, treatment     options are limited. Lactobacilli administration was suggested to treat and prevent vaginal     infections. However, this has not been examined in pregnant women, the information regarding     oral treatment is scarce, and the mechanisms in which oral ingestion of probiotics induce     vaginal lactobacilli proliferation are not well established. In the present study we will     examine if oral probiotics are effective in prevention and eradication of vaginal infections     by migration of lactobacilli from the digestive system to the vagina in pregnant women.   "
37386|NCT02796300|"     Numerous catheter designs have been studied to increase efficacy and minimize complications     of catheter hemodialysis. Major complications of catheters include thrombosis, central venous     stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because     using too many catheters may exhaust all of the catheter insertion sites on the body, as well     as increase the risk of infection. This prospective study compares the complications and     general outcomes of patients who receive hemodialysis using the mainstream Palindrome     catheter versus the newer BioFlo DuraMax catheter.      This study will examine outcomes of patients who receive hemodialysis using either the     Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be     recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions     on which catheter produces less catheter thrombosis.   "
37387|NCT02796287|"     The transient global amnesia (IA) is defined clinically as a temporary suspension and     isolated from the ante and retrograde memory, totally regressing within 24 hours. The causes     of AI remain unknown. The diagnosis of IA is based on consensus clinical criteria including     the absence of associated location marks. In clinical practice, the MRI is often performed in     conjunction with clinical examination because it ensures the absence of differential     diagnoses, including stroke.      The visualization of MRI signal abnormalities related to AI directly dependent on the     completion time of the review in relation to the onset of symptoms. Typically, no signal     abnormality is visible in the hyperacute phase (ie D0-D1) while punctate appear hyperintense     on diffusion sequences in hippocampal structures from J2 to J7 to disappear completely. It     has been previously demonstrated that the use of higher values of b and / or a better spatial     resolution significantly increases the sensitivity of the broadcasting sequence for the     detection of these abnormalities hippocampal signal. At St. Joseph Hospital, Investigators     explore the AI suspected patients with diffusion tensor sequence (DTI) on our high resolution     3T MRI.      Compared to the classical diffusion sequence, DTI is characterized by the use of a greater     number of directions in which the diffusion gradients are applied. One advantage of this     technique is to be able to perform tractography of white matter fibers. Thus the connectome     is a new technique for post-processing of DTI images based tractography and to assess all the     networks of nerve fibers in the brain. By this technique, the values of average diffusivity     (MD) and fractional anisotropy (FA) can be measured along each of the studied nerve fibers.     Group studies thus become feasible to compare quantitatively healthy subjects and patients     groups in terms of structural differences within the connectome. The contribution of this     technique was recently highlighted in patients with temporal lobe epilepsy.   "
37388|NCT02796274|"     The purpose of this survey is to collect visual acuity data from patients with LHON in order     to establish the clinical course (natural history) and visual acuity outcomes in patients     with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data     that will serve as comparator for the open-label study SNT-IV-006.   "
37389|NCT02796261|"     The purpose of this study is to compare the efficacy and safety of eflornithine in     combination with lomustine, compared to lomustine taken alone, in treating patients whose     anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.   "
37403|NCT02796079|"     Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This     study intends to establish an optimal clinical research program, and attempts to break the     technical bottleneck in the stem cell therapy for treating diabetes related vascular     complications.   "
37390|NCT02796248|"     Stigma related to chronic disease is rejection or judgement or exclusion by others that is     related to the chronic disease itself and is unwarranted. We are trying to figure out what     proportion of young people with type 1 diabetes experience stigma in Canada. By young people,     we mean teenagers and young adults; specifically, people who are between 14 and 25 years of     age. This is a challenging period in life when identities are developed and peer opinions are     felt to be particularly important. Experiencing stigma in this life period may be especially     hurtful and may have bad effects on taking care of type 1 diabetes. This may lead to     important medical problems like dangerously low or high blood sugar values. By understanding     how common stigma is, we can figure out the need for programs and strategies to deal with it.      We will ask young people with type 1 diabetes to help us study this problem by completing an     online survey. We will 'advertise' our study through type 1 diabetes clinics, websites, and     social media. People who are eligible and interested will click on an internet link and be     directed to the survey. Staff at clinics in Montreal, Calgary, and Vancouver will also draw     their attention to the posters and/or provide small flyers with the internet link for the     study.      Participants will be asked about their general sense of well-being, their habits and     behaviours, and their blood sugar control, including frequency of both lows and highs. They     will also be asked if they are willing to mail in a small blood sample. If yes, they will     receive a kit with a small lancing device and instructions on how to clean their finger tip,     prick it, and express a few drops of blood into a small container. They will then mail this     back to us in a postage-paid envelope. We will use this to measure their hemoglobin A1c, an     overall measure of blood sugar control.      We will use this information to (1) calculate the proportion of young people with type 1     diabetes who experience stigma; (2) figure out what factors and behaviours might predict or     signal the experience of stigma; (3) see if there is a link between stigma and A1c control     and/or frequent lows by report; (4) explore challenges and solutions voiced through the     open-ended questions.   "
37391|NCT02796235|"     Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to     80% against 10-20% in the general population.      The risk of VTE is very important in the first weeks after spinal cord injury, and then     declines with a prevalence of VTE slightly higher than the general population after 12 weeks.     However there is no prospective study of incidence of VTE in SCI patients after 3 months. The     investigators wish to conduct such a study during the year following spinal cord injury with     performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial     injuryassociated with a standardized clinical assessment, to know the incidence of VTE and     determine prognostic factors for VTE.   "
37392|NCT02796222|"     Recombinant factor VIII Fc (rFVIIIFc) and recombinant factor IX Fc (rFIXFc) are extended     half-life coagulation factors approved by Health Canada in 2014 for the treatment of severe     hemophilia A and B, respectively. The objectives of this observational study is to describe     the change in annual factor consumption, clinical and patient-reported outcomes for patients     who switch from recombinant factor VIII (rFVIII) and recombinant factor IX (rFIX) to     rFVIIIFc/ rFIXFc in Canada, and to explore clinicians' and patients' reasons for switching or     not switching.   "
37393|NCT02796209|"     Atomoxetine, a selective norepinephrine transporter (NET) blocker, increases standing blood     pressure and improves neurogenic orthostatic hypotension (NOH)-related symptoms to a greater     extent than midodrine, the current standard of care. Atomoxetine could be a new therapeutic     alternative for the treatment of NOH in patients with autonomic failure, particularly those     with multiple system atrophy (MSA).      The proposed study consists of an open-label, dose-optimization phase followed by a     randomized, double-blind, placebo-controlled, 2x2 crossover phase.   "
37394|NCT02796196|"     This research trial studies prescribed physical activity in improving sleep and physical     performance in patients undergoing stem cell transplant. A wearable physical activity monitor     can be used to record minutes of activity and sleep. Gathering data over time using a     physical activity monitor may help doctors learn if prescribed physical activity helps     improve sleep and physical performance in patients undergoing stem cell transplant.   "
37398|NCT02796144|"     Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in     patients with schizophrenia, a population for which no current weight-loss treatments have     gained widespread use. The goal is to recruit overweight people with schizophrenia to     participate in a 52-week double-blind, randomized study to assess the efficacy and safety of     lorcaserin/metformin combination treatment, lorcaserin monotherapy, and placebo on weight,     body composition, and measures of glucose and lipid metabolism.      Participants: Approximately 110 subjects will be enrolled at two clinical sites (UNC Chapel     Hill and Columbia University)      Procedures (methods): Behavioral: All participants will be offered a behavioral intervention     of weekly diet and exercise counseling aimed at modifying cardiovascular risk factors. This     intervention will be provided at all in-person study visits after the Baseline Visit and     supplemented with weekly interim phone calls to reinforce lessons between visits.     Pharmacological Intervention: All participants who meet entry criteria will be randomized to     one of the three treatment groups (lorcaserin/metformin, lorcaserin, and placebo).   "
37399|NCT02796131|"     A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the     safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in     healthy volunteers.   "
37400|NCT02796118|"     The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151     after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese     subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and     elderly male Japanese subjects.   "
37401|NCT02796105|"     Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus     GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors   "
37402|NCT02796092|"     This prospective randomized study compares the safety and efficacy of two different     embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and     vascular plugs.   "
37406|NCT02796040|"     Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological     substrates of these symptoms are largely unknown.      The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients     with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging     (DTI).      More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data     obtained with DTI) in the ventral tegmental area (VTA) is different between patients with ICD     and patients without ICD. Secondary objectives are to demonstrate a difference in volume of     VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus     accumbens, amygdala), and in number of fibers between VTA and the other structures of reward     system between this two groups. Other objective is to measure and compare these same     variables between Parkinson's patients and healthy controls.      We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's     patients to ICD.   "
37407|NCT02796027|"     Scaling up integrated, cost-efficient HIV services for people who inject drugs (PWID) in     Needle Syringe Programs (NSPs) is urgently needed in Kazakhstan, where only one-third of the     estimated 19,000 HIV-positive PWID are ever linked to HIV care and only 10% initiate ART with     4% achieving viral suppression. The study's aim is to evaluate the implementation,     effectiveness, and sustainability of an integrated HIV service model in 24 NSPs located in 4     Kazakhstani cities. This model will employ highly effective strategies that will include     peer-driven recruitment of PWID in NSPs using social network strategies (SNS), integrating     rapid HIV testing in NSPs with HIV Care Clinic nurses, and linking HIV positive PWID in NSPs     to HIV care using the ARTAS (Anti-Retroviral Treatment and Access to Services) case     management model. Findings will have important public health implications for improving HIV     service delivery for PWID in the Central Asian region and other countries with injection     driven epidemics.   "
37408|NCT02796014|"     The Dermatological Diseases Family Impact Scale (DeFIS) was developed to assess different     aspects of health-related quality of life in the relatives of the patients with various skin     diseases. The preliminary validation of this instrument was performed for the Turkish     population. In the pilot study, this 15-item-questionnaire was shown to be easy to complete     and score, and reliably help to evaluate the family members' quality of life.      Psoriasis is a chronic disease which can be expected to have a significant impact on the     quality of life of the patients and parents/family members alike. In line with this     assumption, previous studies demonstrated that psoriasis psychosocially affects not only the     patients, but also their close relatives. The psoriasis family index has been developed in an     effort to objectively measure the health-related quality of life of the family members of     patients with psoriasis. Nevertheless, data regarding the health-related quality of life of     the parents of pediatric patients with psoriasis in the Turkish population are relatively     scarce.      In study, the investigators primarily aim to utilize DeFIS to assess the impact of childhood     psoriasis on the quality of life of the patients' parents. Further, the investigators attempt     to investigate the relation between the quality of life of the patients and their parents,     and reveal disease characteristics which might influence the quality of life.   "
37409|NCT02796001|"     The primary objective of this study is to assess the relationship between rhinovirus specific     T-cell immunity and the human host response to primary rhinovirus challenge and subsequent     secondary challenge with either homologous or heterologous rhinovirus serotypes.   "
37411|NCT02795975|"     The objective of this study is to evaluate the performance characteristics of the AC2 assay     on the Panther system using female urine specimens.   "
37412|NCT02795962|"     To evaluate the hypothesis that direct transfer to an Endovascular Stroke Center, compared to     transfer to the closest Local Stroke Center, offers a better outcome in the distribution of     the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with clinically     suspected Large Vessel Occlusion identified by Emergency Medical Services (EMS).   "
37421|NCT02795832|"     A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential     Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice     Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks     in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis   "
37422|NCT02795819|"     This phase 1 study will identify recommended phase 2 doses (RP2Ds) of AR-42 and pazopanib     when given in combination for subsequent clinical trials and may potentially identify     candidate pharmacodynamic and predictive biomarkers.   "
37413|NCT02795949|"     The continuous increase in the bacterial resistance rate and the slow arrival of new     therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by     stewardship programs to try to change this situation described worldwide is the use of     antibiotics with the lowest possible antimicrobial spectrum.      Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The     empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several cases     one or two antibiotics with antipseudomonal activity, being much less common than desirable a     subsequent change to narrower spectrum antibiotics based on susceptibility data (de     escalation). This is because the safety of de escalation is based only on expert advice and     some observational studies, so their efficacy and safety is questioned by many clinicians and     therefore its use is lower than desired. In fact, a recent systematic review of the Cochrane     Library concluded that randomized studies to support this practice are needed. Investigators     propose a real clinical practice-based randomized trial to compare the efficacy and safety     of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified     rule, in patients with bacteraemia due to Enterobacteriaceae.   "
37414|NCT02795936|"     This is a study to find out whether cardiac rehabilitation is a program that can work in     Western Kenya.      This study will test whether cardiac rehabilitation is feasible by measuring how many     participants are able to follow and complete two different exercise protocols; one at home     and one in hospital. It will also measure how the exercise intervention affects quality of     living, depression and improvement in exercise tolerance.   "
37426|NCT02795767|"     This single-arm, multicenter, open-label, Phase III clinical study will enroll children (less     than [<] 12 years of age) and adolescents (12 to 17 years of age) with hemophilia A and FVIII     inhibitors who are currently receiving treatment with bypassing agents. Participants will     receive prophylactic treatment with emicizumab as weekly subcutaneous (SC) doses for 52     weeks. All participants will continue to receive episodic treatment for breakthrough bleeds     as needed. Breakthrough bleeds should preferably be treated with recombinant factor VIIa     (rFVIIa) only at the lowest dose expected to achieve hemostasis and use of activated     prothrombin complex concentrate (aPCC) or other bypassing agents (e.g., Byclot®) should be     avoided.   "
37415|NCT02795910|"     This study will evaluate a complex intervention based on a patient management tool (PMT),     combined with educational outreach to primary care doctors, nurses and other health workers,     in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of     primary health care and health outcomes, in adults with diabetes and cardiovascular disease     (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48     primary care clinics to receive the intervention or not, and comparing patient and clinic     level endpoints that reflect the health and quality of care provided over the following year.     About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD     (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or     cerebrovascular disease) in participating clinics will be included in the study. About 7800     of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of     participants in whom at least one of the following tests was recorded: body mass index,     plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis     of hypertension recorded previously, average systolic blood pressure recorded. Secondary     endpoints will include the individual components of the composite scores, health measures     (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid     conditions such as depression. Eligible patients will be identified and outcomes measured     using electronic medical records.   "
37416|NCT02795897|"     The purpose of this study is to look for abnormal genes and gene expression profiles that     help determine why a person develops amyotrophic lateral sclerosis (ALS) and related motor     neuron diseases (MND) and why their symptoms present and progress with a particular pattern.   "
37417|NCT02795884|"     This study will be performed as a local multicenter, randomized, phase III clinical study. It     will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon     19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant     chemotherapy with the chemotherapy alone. The patients will be randomly assigned to the     Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the     ratio of 1:1. The treatment regimen of each arm is as follows.   "
37418|NCT02795871|"     The classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause     of congenital adrenal hyperplasia (CAH). This autosomic recessive disease is responsible for     virilization of the external genitalia in girls through androgen hypersecretion during fetal     life. Since 1984, the Lyon Pediatric Endocrinology group has proposed prenatal dexamethasone     (DEX) for all fetuses at risk of CAH With the aim of preventing fetal androgen hypersecretion     in affected girls and avoiding poor long-term results from reconstructive surgery. Prenatal     DEX was used in Europe and the USA but its use was recently suspended: in 2007, a Swedish     study conducted on 26 children treated with DEX in utero for a short period of time reported     cognitive impairments. These data were not confirmed by an American study on the short-term     DEX use, which showed potential cognitive impairments in CAH children exposed to DEX for long     periods of time. These confusing and controversial results have caused the scientific     community to question its position and have resulted in the suspension of the use of prenatal     DEX with drastic consequences for CAH girls (virilization; genital surgery etc.). In this     context, an evaluation of neuropsychological development under in utero DEX is essential to     validate its indication for use during the prenatal period. This study will evaluate outcomes     using prospective cognitive and emotional assessments. It will first focus on the unaffected     children previously treated in utero in order to assess the adverse effects of the drug. The     study will then assess the children with CAH for whom DEX could have beneficial effects.   "
37419|NCT02795858|"     This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced,     Progressive Carcinoid Tumors.   "
37489|NCT02794922|"     The purpose of this study is to determine effectiveness of vitamin B in reducing     temporomandibular joint disorder (TMD) pain. Patients will be randomised to receive the study     drug or placebo. The study drug we are using is a combination of vitamin B1(thiamine     mononitrate)-242.5mg; vitamin B6(pyridoxineHCl)-250mg, and vitamin B12(cyanocobalamin)-1mg.     We will assess patient's pain level, range of jaw movement and record any side effects from     using this medication.   "
37423|NCT02795806|"     Background: Electronic health records contain a vast amount of data about diseases and     treatments. Researchers could use this data to test their ideas, but they would need to use     records from more than just their own group of patients. But access to those records is     restricted to ensure patient privacy.      U.S. National Library of Medicine (NLM) has created a computer tool called NLM Scrubber. This     program recognizes and deletes personal information from health records. The researchers who     developed this program now need access to the original records. This will allow them to see     how well the program removes personal information from patient records and how they can make     it more accurate.      Objectives:      To find ways to improve clinical text de-identification.      Eligibility:      No new participants. Researchers will review data that have already been collected.      Design:      Researchers will collect a random sample of reports. These will be from different doctors in     different fields.      Researchers will manually remove personal information from the records.      Researchers will also automatically remove personal information from original records using     NLM-Scrubber.      Researchers will compare the results of the computer program versus the manual changes. They     will note when the program has not been removing personal information correctly. They will     also note when the program has been deleting nonpersonal health information incorrectly.      Researchers will use the results to revise the program. They will keep testing it until the     de-identification process is complete.   "
37427|NCT02795754|"     GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for     the treatment of HIV in combination with other antiretroviral therapy (ART). The primary     objectives of this study are to investigate the safety, tolerability, and pharmacokinetics     (PK) of single and repeat doses of GSK2838232. This study will be a double-blind,     placebo-controlled, single and repeat dose escalation study. This study will be conducted in     two Parts: single escalating doses (Part 1A and 1B), and repeated escalating once daily (QD)     doses for 11 days (Part 2) of GSK2838232 co-dosed with RTV. During Part 1A, single doses of     GSK2838232 (as of active pharmaceutical ingredient-powder in bottle [API PiB]) 50 milligrams     (mg), 100mg and 200mg will be administered with RTV. Part 1B will evaluate the relative     bioavailability of single doses of crystalline active pharmaceutical ingredient (API)     Immediate Release Tablet (IR) tablets versus API PiB as reference, administered with RTV. In     Part 2, multiple doses of GSK2838232 will be co-administered with RTV 100mg QD for 11 days as     sequential dose cohorts. Maximum duration of study participation will be approximately 10     weeks.   "
37428|NCT02795741|"     The Cooling Bolero is a a vest filled with a new material (not ice or a gel) that provides     controlled cooling by absorbing heat. The vest is manufactured by Nanohealth. It intended to     provide moderate cooling (~15C/59F) through indirect contact with the skin. The material in     the device is safe, non-toxic, and eco-friendly.      Recent anecdotal studies of women with common peri-menopausal and menopausal symptoms (hot     flashes, night sweats, flushing/sweating of face and neck, and intermittent sleep     disturbances) have shown a reduction in both the frequency and intensity of those symptoms     after using the Cooling Bolero. Specific (moderate) temperature cooling of the neck and upper     torso appears to target and mitigate these common menopausal symptoms. This pilot study     attempts to collect additional data on the effects of the Cooling Bolero.   "
37429|NCT02795728|"     Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure     sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design     ,a double blind randomized controlled clinical trial was conducted to compare the retention     and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer     sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group.     The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the     first mandibular permanent molars. They were recalled for assessment of sealant retention at     intervals of 3, 6 and 12 months.   "
37430|NCT02795715|"     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual     associative memory leads to a performance improvement in healthy older individuals.   "
37431|NCT02795702|"     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual     associative memory leads to a performance improvement in healthy older individuals.   "
37432|NCT02795676|"     This is a randomized, double blind, active control study of PRX-102 in Fabry disease patients     with impaired renal function. Patients treated for at least 1 year with agalsidase beta and     on a stable dose for at least 6 months will be screened and then randomized to continue     treatment with either agalsidase beta at the same dose or to treatment with 1 mg/kg of     PRX-102. The identity of the enzyme will be blinded to the patient and the investigator.     Patients will receive intravenous infusions every two weeks. Patients will be randomized in a     2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein     to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample.   "
37433|NCT02795663|"     -  Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective          treatment for a large variety of movement disorders. However, the efficacy of STN-DBS          relies on unclear mechanisms.        -  Purpose: In this study, using optical imaging, the investigators will evaluate the          cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor          task and delay discounting task. the investigators will perform an optical imaging study          using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The          investigators will measure bilateral local cortical hemodynamic changes under On and          Off stimulation conditions and during a motor task (left hand movement) and delay          discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will          be continuously analyze.        -  Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total          Hb) under  on  and  off  stimulation during a motor task.   "
37434|NCT02795650|"     This is a multicenter, open label, randomised phase II clinical trial for patients with     metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will     undergone tumoral biopsy before starting first line of treatment and will be administered     personalised therapy as second or third line.   "
37435|NCT02795637|"     Study of the what the body does to the drug in subjects with mild, moderate, and sever liver     dysfunction (not working properly)   "
37436|NCT02795624|"     Specific Aim 1. Characterize the long-term effects of secondhand smoke (SHS) on vascular     health in pre-ban flight attendants (FAs). Investigators will measure arterial stiffness     (pulse wave velocity and augmentation index) and endothelial dysfunction (reactive hyperemia     index) in the pre-ban FA cases, and compare to the cardiovascular risk-factor matched     Framingham controls.      It is hypothesized that pre-ban FA cases have increased arterial stiffness (higher pulse wave     velocity and higher augmentation index) and increased endothelial dysfunction (lower reactive     hyperemia index) compared to Framingham controls.      Specific Aim 2. Determine the extent in which remote pre-ban SHS exposure (hours) is     associated with increased arterial stiffness or endothelial dysfunction.      Investigators hypothesize that pre-ban SHS exposure is positively associated with both     increased arterial stiffness and increased endothelial dysfunction.      Specific Aim 3. Investigators will calculate the cardiovascular risk scores (Framingham,     Reynolds, and ASCVD) by using subjects' age, blood pressure, family history, lipid panel, and     highly sensitive C-reactive protein. Investigators will explore the association of the risk     scores with measures of vascular aging (arterial stiffness and endothelial dysfunction).     These scores do not include SHS exposure. Investigators will also test the additive value of     SHS exposure in increasing arterial stiffness and endothelial dysfunction using the risk     scores as an adjustment value.      It is hypothesized that the cardiovascular risk scores are associated with vascular aging     (arterial stiffness and endothelial dysfunction), and that the association between SHS     exposure and vascular aging remains significant after adjusting for the cardiovascular risk     scores.      The significance of this proposal and impact will be (1) mechanistic insights into how remote     SHS exposure leads to hypertension and vascular stiffness, (2) increased understanding of how     SHS exposure can increase risk of cardiovascular disease, which is the number one cause of     death in the United States.   "
37437|NCT02795611|"     Play skills and participation of children with Autism Spectrum Disorder (ASD) have been     restricted by their core symptoms, resulting in heightened parenting stress and affected     family daily life. This research aims to improve play skills and participation of children     with ASD through 'family-centered occupational therapy', thereby leading to positive outcome     for not only the child but also the whole family.   "
37439|NCT02795585|"     Quantitative Flow Ratio (QFR) is a new method for evaluating the functional significance of     coronary stenosis by calculation of the pressure in the vessel based on two angiographic     projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed     during coronary angiography and compare diagnostic accuracy to standard FFR.   "
37440|NCT02795572|"     The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg     oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three     times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer     Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or     reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).   "
37441|NCT02795559|"     It has been suggested that obesity occurs because the colonic microbes in obese individuals,     compared to those who are lean, produce more short chain fatty acids during the fermentation     of dietary fiber; this means that obese individuals obtain more energy from dietary fiber     than lean. On the other hand, it is possible that the ability of colonic short chain fatty     acids to improve glycemic control and suppress appetite may be reduced in obese subjects. The     aim of this study was to determine the acute effects of 2 fibers commonly used as food     ingredients, inulin and resistant starch, on postprandial serum responses of short chain     fatty acids, glucose, insulin, free-fatty acids and selected gut hormones in lean and     overweight or obese subjects.   "
37442|NCT02795546|"     The aim of the present study was to evaluate the bone formation potential of 400µg     alendronate delivered in β-TCP in the treatment of periodontal intra-osseous defects.   "
37443|NCT02795533|"     The current study is a continuation of the study Effect of early rehabilitation in patients     with acute aSAH which was approved by the Regional Committee for Medical Research Ethics,     South-East Norway, archive number 2011/2189, Clinical Trials number 0925-0586 (Clinical     Trials gov. identifier NCT01656317). The original study was a prospective, controlled,     interventional study comprising patients managed at the neuro-intermediate ward following     repair of a ruptured intracranial aneurysm in 2011-2012. 157 patients signed the informed     consent form and were included in the study. Patients were assessed in the acute phase, as     well as a 3 and 12 months post ictus. The main research goal of the present study will be to     assess physical, cognitive and emotional function 5 and 10 years after aSAH in the 2011-2012     population. In addition we will also describe quality of life and work-status along with the     time-course of recovery from the acute sage after aSAH to the chronic phase.   "
37444|NCT02795520|"     The purpose of Phase I of this study is to test the safety and tolerability of the     investigational drug, OTS167, and that of Phase II of this study is to confirm the potential     response benefit of OTS167.      OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which demonstrated     antitumor properties in laboratory tests. It is being developed as an anti-cancer drug. In     this study OTS167 will be administrated to patients with AML, ALL, advanced MDSs, advanced     MPNs, or advanced CML.   "
37446|NCT02795494|"     Patient oriented clinical outcomes have increased in use and popularity and provide a     comprehensive assessment of the level of symptoms and function experienced by a patient.     Though several measures have been developed and shown to be valid, reliable, and responsive     in adults, such efforts have only been rarely undertaken in pediatric populations.     Specifically, there has been no validation of the predominant adult hip specific outcome     measures, such as the WOMAC and Oxford-12, in children and adolescents. Prior to using such     measures in pediatric patients, it is necessary to establish the psychometric properties of     these measurements in this population.      The objective of this study is to determine the reliability and validity of the WOMAC hip     scores in a pediatric population, between five and nineteen years of age, with Perthes     disease. The results of this study will accomplish the above goal, thereby allowing either     for widespread use of these measures in pediatric hip disorders or emphasizing the necessity     for development of a pediatric hip specific outcome measure.   "
37456|NCT02795364|"     Gliomas,especially high-grade glioma ,are the most common primary malignant brain tumor in     adults,yet outcomes from this aggressive neoplasm remain dismal.The extent of resection is     one of the most essential factors that influence the outcomes of glioma resection.However,     conventional structural imaging has failed to accurately delineate glioma margins because of     tumor cell infiltration. the investigators have finished few project that suggest the     feasibility of Magnetic Resonance Spectrum(MRS)-guided resection,unfortunately, lacking     sufficient clinical evidence.This prospective cohort study is to provide a clinical evidence     for the validity of MRS-guided resection in patients with HGG .   "
37457|NCT02795351|"     In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and     migraine headache induction is tested in patient with migraine with aura.   "
37975|NCT02788578|"     The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG)     combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive     neuroendocrine tumours located in the lung or in the digestive system as there is currently     limited data on these treatments used together for these types of neuroendocrine tumours.   "
37447|NCT02795481|"     Stroke is one of the leading causes of death and disability in the UK and currently costs the     country £7bn per year. There is an overwhelming need to accurately and rapidly triage     patients to allow best use of finite NHS specialist resources for the treatment of stroke.      A simple blood test of substances (the purines) that result from cellular metabolism and are     produced in excess when brain cells are starved of oxygen and glucose (as occurs during a     stroke) is proposed. The sensors designed by the investigators are used to measure blood     purines during a procedure in which blood flow to the brain is reduced to allow surgical     interventions on the major arteries that supply the brain. Previous studies by the     investigators have shown that as soon as blood flow to the brain is reduced, purines are     produced within minutes and are detectable in systemic arterial blood.      The current project will now compare the levels of purines in the blood of stroke patients     and controls. The purines will be measured on admission to hospital and 24 hours later. The     occurrence and magnitude of a stroke will be determined by an MRI scan given between 24 and     72hrs after admission. This study will establish whether purines are elevated in the blood of     stroke patients on admission to hospital compared to healthy controls, and whether this     correlates with the size of the stroke and damage to the brain.   "
37448|NCT02795468|"     The investigators are trying to compare the ultrasound-guided technique vs. palpation method     for radial arterial cannulation in infants.   "
37459|NCT02795325|"     A phase 1 study of DCR-PH1 in patients with primary hyperoxaluria type 1 (PH1) to determine     the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics (PD) effects of DCR-PH1     administered via-intravenous infusion (IV)   "
37460|NCT02795312|"     This is a study designed to mindfulness based stress reduction (MBSR) training program to     assess feasibility and acceptability of the intervention. Participants will participate in a     9-week training program and complete pre-and post-questionnaires. Participants will have the     option of participating in a follow-up focus group.   "
37461|NCT02795299|"     Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate     Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.   "
37449|NCT02795455|"     The researchers plan to explore brain networks involved in emotion processing and learning     using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a     small number of high-calorie or high-fat foods. By studying why individuals with AN are     disgusted by food or other eating situations, the researchers will be able to understand more     about the neurobiological pathways that lead to restricting food intake and food avoidance.     This study also aims to find whether one of two short-term interventions (Interoceptive     Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain and if the     treatments affect food avoidance. IE is an intervention that helps reduce anxiety about     eating. FBT is an intervention that motivates patients to eat through working with family to     increase the value of eating and decrease the value of avoiding foods.   "
37450|NCT02795442|"     The purpose of this study is to determine if when one eats protein can change how the body     uses food for energy. Researchers will also test if eating a high protein breakfast can     change one's craving for snack foods.   "
37451|NCT02795429|"     The purpose of this study of INC280 and PDR001 is to characterize the safety, tolerability,     pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered     i.v. as a single agent or in combination with INC280 administered orally in adult patients     with advanced hepatocellular carcinoma (HCC).   "
37452|NCT02795416|"     Secukinumab targets a different interleukin and has potential to be used as alternative to     existing treatments. This study will provide clinical data with respect to efficacy through     Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and     evaluate the impact of the treatment on quality of life and work productivity in subjects     with moderate to severe plaque psoriasis in the Turkish population.   "
37453|NCT02795403|"     The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough     understanding of the biology of one of its major causative agents, the hepatitis C virus     (HCV). HCV particles acquire via budding and encapsidation cellular proteins. There is     mounting evidence on several viral species that virion-bound proteins are prone to be     involved either at the replication, budding/egress or entry/release steps of the viral cycle.      Identifying such targets may yield ideal candidates for gaining insight on the dependence of     HCV upon a restricted subset of host proteins, therefore providing refined sets of     genetically stable targets for therapy. This project's goals are to set up adequate     conditions for robust and reproducible purification of HCV virions in clinical samples,     followed by the identification of their HCV-bound host proteins and the characterization of     their functions. Proteomics profiling of HCV particles purified from clinical samples will be     overlaid with proteins identified and characterized in cell culture grown HCV particles     during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets     identified in both samples sets will be subjected to in vitro investigations using     HCV-replicating cells. Conventional biochemical and imaging methods will be used in order to:     (i) ascertain their physical association with HCV virions; (ii) define the modalities of     their interaction with HCV proteins; (iii) decipher the topology and subcellular localization     of their association with HCV proteins and virions; (iv) quantitatively assess their     functional involvement in particle budding, egress or secretion and infectivity. A candidate     that yielded satisfactory results in these experiments will be disclosed and further     investigated at the level of structural biology, in collaborative research programs.   "
37454|NCT02795390|"     It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients     with constipation. 60 patients will be randomly assigned to have individualized herbal     intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment     group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six     herbal granules can be added according to the syndrome differentiated for individual     participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%),     and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal     granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily     for two weeks. The primary end point is the global symptom improvement. Secondary outcome     measures include stool frequency, stool form, use of rescue herbal granules, constipation     visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of     constipation related symptoms. For the safety profiles of herbal intervention, the important     adverse events reported and clinical laboratory evaluations of liver and renal function are     determined.   "
37455|NCT02795377|"     Membrane microparticles are submicron fragments of membrane vesicles shed from various cell     types. Circulating endothelial microparticles have been proposed as markers of endothelial     injury. However, which mechanical forces contribute to their release is not clear.   "
37458|NCT02795338|"     It is unknown whether imaging technologies have broad applications in brain mapping due to     limited knowledge of the value of the results. Accurate identification of areas of eloquent     brain function is vital to surgical decision making and to preservation of independence as     patients with brain tumors who are higher functioning have better survival outcomes. Imaging     technology has evolved to provide multiple non-invasive modalities for pre-operative testing     of eloquent brain function and include functional MRI (fMRI) and magnetoencephalography     (MEG). Eloquent brain is defined as a region controlling language, motor, or sensory function     such that without its proper input, a person would be left with significant neurologic     deficits.      Studies conducted by our group and others have shown that these non-invasive mapping     modalities provide useful information, however, the information provided inconsistently     predicts distribution of eloquent function.      Direct electrical stimulation (DES) at the time of surgery allows assessment of eloquent     function directly from the brain surface (invasive) and is considered the gold standard in     brain mapping. Therefore, in order to determine the true clinical applicability of the     non-invasive mapping technologies, we propose to: (1) assess the predictive value of fMRI and     MEG for sensorimotor and language functions by comparing their results to DES and (2)     determine whether fMRI or MEG provides the most consistent and accurate information. We will     accomplish these Aims by co-registering all mapping data (invasive and non-invasive) in a     modifiable 3D rendering. In this way, we can evaluate the DES to fMRI and MEG as well as     compare fMRI to MEG. The rationale for the proposed research is that understanding the     reliability of our current technology will allow us to perform safer surgeries and to     preserve neurologic function. The expected outcomes for the work proposed in Aims 1 and 2 are     identification of a predictive value for fMRI and MEG and determination if one modality     should be utilized over the other pre-operatively for the most accurate information. The     results of this study are expected to have an important positive impact because     identification of accurate pre-operative non-invasive mapping modalities will allow tailored     testing and possibly lead to negation of the need for intra-operative mapping in certain     cases. It will also enhance patient outcomes by improving patient safety. Furthermore, it     will serve as the basis for a multi-institutional mapping data bank.   "
37462|NCT02795286|"     The ASIST study is a medical device study testing the safety and efficacy of a new     hemodialysis machine software in chronic haemodialysis patients. The software's intention is     to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by     adapting the dialysis fluid ion concentration to the patients plasma ion concentration by     conductivity measurement.   "
37463|NCT02795273|"     The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and     to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication     during the grass pollen season   "
37464|NCT02795260|"     The investigators recruit about 1800 cases participants who has signed ICF,then do some     physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific     gamma-interferon detection ,collection of medical history and the like .These subjects who     meet the standard are considered as study population I. Population I are injected     intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at     different arm of the same subject and get at least 360 participants whose three kinds of     detection result are all negative and are considered as study population II.Then,they are     immune to the Bacillus Calmette -Guerin(BCG) vaccine or the placebo of the BCG.Do specific     gamma-interferon detection before the skin test,then inject intradermally with ESAT6-CFP10     and TB-PPD at different arm of the same subject 12 weeks after immunity.   "
37465|NCT02795247|"     The purpose of this study is to compare the tomographic results of patients who underwent     single-bundle anterior cruciate ligament reconstruction at the investigator's institution     using the transtibial, accessory medial portal technique and the modified transtibial     technique to determine which technique best recreates the anterior cruciate ligament anatomic     footprint.   "
37466|NCT02795234|"     The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups     of patients and healthy volunteer. A second goal is to find the relation between Vitamin D     Antibody and Vitamin D level.   "
37467|NCT02795221|"     Systemic sclerosis (SSc) is multisystem autoimmune disease of unknown etiology. It's     characterized by activation of immune system, microvascular changes and intimal     proliferation.      The EULAR/ACR 2013 criteria for the classification of SSc will help identify SSC patients     before fibrosis of internal organs and will allow early treatment.      Patient with RP, SSc-related autoAb, anti-topoisomerase I (SCL-70), anti-centromere autoAb,     anti-RNApolymerase III, abnormal nailfold capillaries and puffy hands would have SSc.      The OR of abnormal capillaroscopy for subsequent development of SSc can reach 163 with     positive predictive value of 52% and negative predictive value of 99% .Some studies found     that preclinical internal organ involvement in pre-scleroderma patients, DLCO<80% was     detected in 11/32 patients with RP plus SSc-associated autoAb plus SSc-type nailfold     capillary changes.      The heritability of SSc was considered controversial in the, largest published SSc .Twin     study, which in general suggested a modest genetic contribution to the Phenotype     .Nevertheless, this study included only 42 sets of twins, and it should Be considered that,     in a family study of 703 cases, an affected first-degree relative Increased the risk of SSc     13 times compared to the general population . Moreover, having an affected sibling increased     SSc risk by 15 times , and there Was a remarkable concordance of auto antibodies between SSc     twins . Additionally, recent analyses have shown that the standardized incidence ratio of SSc     seemed to be less than those observed in autoimmune diseases (ADs) such as Rheumatoid     arthritis or Ankylosing Spondylitis, but similar to those observed for Hashimoto, thyroiditis     or psoriasis. In addition, SSc prevalence, clinical Outcomes and autoantibody profiles have     been reported to vary depending on Patient ancestry Therefore, the role of genetic factors in     SSc susceptibility can now be considered solidly established.      A positive family history of SSc appears to confer a risk that is at least 10-16-fold Higher     than normal for SSc in first-degree relatives and 10-27-fold higher than Normal for SSc in     siblings, and thus represents the strongest susceptibility factor Yet reported for this     disease .   "
37468|NCT02795208|"     This study test whether a lung recruitment maneuver improves the right ventricle performance     after cardiopulmonary bypass. Half of the patients received an standard protective     ventilation and the other half the same ventilatory pattern after a lung recruitment     maneuver.   "
37469|NCT02795195|"     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation     using carbon ion radiotherapy (CIRT) with the fraction size of 3 GyE in the treatment of     locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment     at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate     the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and     within 4 months after the completion of CIRT. Once the MTD for locally recurrent NPC is     determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion     criteria in the Phase II part of the trial.   "
37470|NCT02795182|"     This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with     BGB-A317 in subjects with B-cell lymphoid malignancies.   "
37471|NCT02795156|"     With the increased availability of next-generation sequencing, oncologists are starting to     incorporate genomic profiling into routine care of cancer patients. If a genomic alteration     is identified during profiling, it could help guide the choice of therapy and improve     treatment outcomes. This study will examine the anti-tumor activity of two FDA-approved     therapies to treat patients who were previously profiled with next-generation sequencing     technology and who failed first-line treatment for one of the following tumor types:     non-small cell lung cancers; urothelial cancer; non-colon gastrointestinal cancers, and upper     aerodigestive tract cancer.   "
37473|NCT02795130|"     Small-incision vitrectomy techniques have become increasingly popular, with a number of     advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23- and     25-gauge trocar systems theoretically do not require sutured closure. However, a certain     fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require suture     placement. Poor wound closure puts the patient at increased risk of post-operative hypotony     and is associated with increased risk of endophthalmitis. Currently, surgeons are divided as     to which suture is the best for sclerotomy closure. The current standard of care is 8-0     polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to work with;     however, it triggers a robust inflammatory response. The alternative is 6-0 plain gut suture,     which is more difficult to manipulate and thicker, but causes less tissue inflammation1. The     purpose of this study is to prospectively evaluate these two options for sclerotomy closure.     The results of this study will enable us to minimize patients' post-operative discomfort     while maximizing safety outcomes.   "
37474|NCT02795117|"     The purpose of this study is to compare the safety and efficacy of Perrigo's product to an     FDA approved product for the treatment of inflammatory lesions rosacea   "
37475|NCT02795104|"     This randomized clinical trial studies how well a tailored interactive digital versatile disc     (DVD) with or without patient navigation works in improving screening rates in rural women     for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and     patient navigation may help rural women to learn more about cancer screening and to better     understand the results.   "
37476|NCT02795091|"     Multidrug resistance bacteria infection is common in ICU. Infection incidence is associated     with age, organ dysfunction, invasive treatment and enviroment cleaning. According to     hospital hygienic standard for disinfection, total numbers of colony of air and the object     surface in ICU must be ≤4CFU/cm2（5min）and≤10CFU/cm2. in this study, the two different methods     will be used to evaluate the disinfection effects in ICU enviroments.   "
37477|NCT02795078|"     Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common     causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess     the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial     stenosis.   "
37478|NCT02795065|"     The purpose of this study is to compare two types of low-molecular-weight heparin, enoxaparin     and bemiparin, as regards their efficacy and safety in venous thromboembolism prevention     among intensive care unit patients.   "
37479|NCT02795052|"     This is a human clinical study involving the isolation of autologous bone marrow derived stem     cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in     order to determine if such a treatment will provide improvement in neurologic function for     patients with certain neurologic conditions.   "
37480|NCT02795039|"     The purpose of this study is to demonstrate bioequivalence between the test drug product,     fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50     mg/mL.   "
37481|NCT02795026|"     Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor     dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other     pathology exists. The effectiveness of manual therapy in studies have shown statistically     significant pre and post treatment differences.However no study has reviewed the efficacy of     inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD.     This study will investigate the effectiveness of trans-perineal trigger point dry needling     used with manual therapy techniques for CPP.   "
37482|NCT02795013|"     Hodgkin lymphoma (HL) is a relatively rare disorder with known familiar aggregation (i.e. HL     in more than one child, or parent and child). Because affected individuals in familial HL are     genetically related, the existence of such families has long been considered as evidence in     support of a genetic basis of HL susceptibility. However, it is largely unknown which genetic     variations are responsible for recurring HL in families. Because the effects of genetic     variants are likely to be strong in familial HL, identification of such variations will     potentially reveal biological pathways critical to the pathogenesis of HL.      PRIMARY OBJECTIVE:        -  To perform genome-wide sequencing of families with recurring Hodgkin lymphoma cases          (affected as well as non-affected family members) to identify potential disease-causing          germline genetic variations.      SECONDARY OBJECTIVE:        -  To describe demographic and clinical features of the affected families.   "
37483|NCT02795000|"     The purpose of this research is to develop a predictive nomogram for primary ovarian     insufficiency.   "
37484|NCT02794987|"     Endoscopic retrograde cholangio-pancreatography (ERCP) is a diagnostic and therapeutic     procedure, however it has an important image limitation. The fluoroscopic cholangiography     shows the biliary tree in a two-dimensional view. When an indeterminate biliary stricture is     seen, the certainly diagnosis by ERCP depends on a blind biopsy sampling with the risk of     missed pathology and sampling errors. SpyGlass® System (Boston Scientific, Marlborough,     Massachusetts, USA) is a cholangioscope that enables single-operator, direct visualization of     the pancreatico-biliary system and the evaluation of intraductal lesions. It has a digital     sensor with 4x resolution and a 1.2 mm working channel that allows the passage of the     SpyBite® Forceps biopsy. It has been demonstrated that the use of SpyGlass® System and     SpyBite® Forceps changes clinical management in 64% of patients. It has a sensitivity of     76.5% for indeterminate stricture diagnosis, compared to 29.4% and 5.9% sensitivity using     blind biopsy brushing catheter respectively. Although it has been described before     cholangioscopic images of malignant biliary lesions like an irregular lesion surface with     irregular vessels and bleeding or a smooth surface without vessels for benign lesions, there     is no current validated classification that allows unify the diagnostic criteria.      Methods: Study design: The study was design to be performed in 2 stages. Stage 1:     observational, retrospective study with case collection from September 2013 to September     2015. Patients included had bile duct tissular lesion detected by POCS. The images were     correlated to histopathology and 6 month follows up and a classification was finally     performed to differentiate benign forma malignant bile duct lesions. Stage 2: patients with     bile duct tissular lesion detected by POCS, will be the evaluated in a prospective,     non-randomized and double blind manner. Two groups of endoscopist will evaluate the images     but only one group will do it using the classification previously performed. Second stage     case collection has already started (December 2015) and will include patients until December     2016.        -  Endpoint Classification: Efficacy        -  Intervention Model: Non interventional        -  Primary Purpose: Diagnosis   "
37485|NCT02794974|"     The investigators test with the present study design, whether an ultrasound-guided blockade     of the cervical plexus in combination with an additional application of local anesthetic to     the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of     anesthesia.   "
37486|NCT02794961|"     CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present     study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.   "
37490|NCT02794909|"     The proposed study is a prospective cohort study in which a select group of emergency     physicians at Komfo Anokye Teaching Hospital (KATH) in Ghana will be trained in     cardiopulmonary ultrasound (CPUS). Following the training, patients who present to the ED     with undifferentiated shock and/or dyspnea will either receive usual and customary care     supplemented with cardiopulmonary ultrasonography-guided diagnosis and treatment during their     initial resuscitation, or usual and customary care alone depending on whether the treating     physician has received CPUS training. The main outcomes is the impact of CPUS on correct     diagnosis. Information regarding initial treatment strategies, diagnoses and 24-hour     mortality will be collected via manual review of paper charts and medical records.   "
37491|NCT02794896|"     Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells     effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects     undergoing extended shoulder surgery under continuous regional anesthesia randomly were     assigned to a deep or a shallow anesthesia level (BIS <35 or >55) for more than an hour.     Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte     phagocytosis activity.   "
37492|NCT02794883|"     The main purpose of this trial is to investigate the effects of a new class of drugs that     help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These     drugs have already shown benefit in some other cancer types and are now being explored in     GBM. Both tremelimumab and durvalumab (MEDI4736) are investigational drugs, which means     that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are     antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab     attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain     blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the     immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune     cells. Combining the actions of these drugs may result in better treatment options for     patients with glioblastoma.   "
37493|NCT02794870|"     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in     RSV-seronegative infants 6 to 24 months of age.      This study is a companion study to CIR 311.   "
37494|NCT02794857|"     This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence     of systemic inflammation. Half of participants will receive NP001 and the other half will     receive placebo.   "
37495|NCT02794844|"     USING GENETIC INFORMATION ABOUT THE INDIVIDUAL TO PICK THE RIGHT DRUG FOR THE RIGHT DISEASE     AT THE RIGHT DOSE DEFINES PERSONALIZED MEDICINE. THIS PILOT STUDY SEEKS TO INSTITUTE     PHARMACOGENOMIC TESTING, THAT IS IDENTIFYING GENETIC VARIATION THAT INFLUENCES PATIENT     RESPONSE TO DRUGS, INTO THE NEMOURS CHILDREN'S HEALTH SYSTEM. WE PROPOSE TO INITIATE THE     STUDY BY IDENTIFYING GENETIC DIFFERENCES IN CYP2C19, A GENE THAT IS RESPONSIBLE FOR A CERTAIN     ENZYME IN THE LIVER THAT METABOLIZES MANY DRUGS INCLUDING A CLASS OF DRUGS CALLED PROTON PUMP     INHIBITORS (PPI; PREVACID, NEXIUM). PPI ARE USED TO TREAT HEARTBURN AND OTHER SYMPTOMS OF     GASTROESOPHAGEAL REFLUX DISEASE (GERD) AND ARE EXTENSIVELY USED IN PEDIATRICS. CHRONIC USE OF     PPI CAN CAUSE SERIOUS SIDE EFFECTS INCLUDING COLD, PNEUMONIA AND STOMACH INFECTIONS, WHICH     GETS WORSE AT HIGHER DOSES. CHILDREN WHO POORLY METABOLIZE DRUGS BECAUSE OF GENETIC VARIATION     IN CYP2C19 SHOULD GET LOWER DOSES OF PPI THAN CHILDREN WHO METABOLIZE PPI NORMALLY. OUR PILOT     STUDY WILL GENOTYPE CHILDREN WITH GERD OR OTHER STOMACH ACID MEDIATED CONDITIONS FOR WHICH A     PPI IS PRESCRIBED USING A SAMPLE OF SPIT TO DETERMINE WHICH DOSE OF PPI THEY GET BASED ON THE     FORM OF THE CYP2C19 GENE THEY HAVE. WE WILL STUDY 120 CHILDREN 2-17 YO DIAGNOSED WITH     GASTROESOPHAGEAL REFLUX DISEASE (GERD) OR OTHER STOMACH ACID MEDIATED CONDITIONS FOR WHICH A     PPI IS PRESCRIBED . GENETIC RESULTS ARE AVAILABLE IN < 60 MINUTES, AND THEIR DOSES ARE     DETERMINED BY THEIR DOCTOR BASED ON GENETIC RESULTS. THIS STUDY WILL ALLOW US TO GAIN     VALUABLE EXPERIENCE THAT WILL BE USED TO EXPAND OUR GENETIC PROGRAM TO OTHER GENES AND DRUGS.   "
37496|NCT02794831|"     -  NSAIDs are widely consumed, and some are currently available for self-medication with          indications 'Pain and Fever' (Cavalié, National Agency for Drug Safety (ANSM), 2014)        -  There is no recommendation to limit their use in bacterial infections except for chicken          pox in children.        -  To date, no study has highlighted the aggravating role of exposure to NSAIDs on          bacterial infections in adults, based on the usual septic severity Levy's score (SSS),          and mortality, but it delays adequate antibiotics (Legras, Critical Care, 2009)        -  Community-acquired bacterial infections in adults exposed to NSAIDs are serious by their          spread (multiple locations), and suppurative character requiring frequent use of          invasive procedures such as surgery or drainage. The SSS does not reflect the          seriousness of these infections. They are frequently associated with use of ibuprofen          (63.4%), and self-medication practices (65.5%).      The main hypothesis is that NSAIDs exposure is associated with a specific severity of     community-acquired bacterial infection, marked by dissemination, suppurative complications or     even invasive procedures requirement.      Our objectives are also to:        -  Describe what NSAID use terms are associated to the risk of serious bacterial          infections: molecule, dosage, duration of exposure, access (prescription or          self-medication), associated drugs.        -  To determine what type (s) (s) of bacterial infection is worsened by exposure to NSAIDs.        -  To determine if other risk factors contribute to severity of bacterial community          acquired infection        -  To describe hospital costs associated to such severity of bacterial infection   "
37497|NCT02794818|"     To provide prescriptions for weekly Community Supported Agriculture (CSA) boxes of fruits     and vegetables to patients, accompanied by nutritional education (e.g. printed newsletters     and YouTube videos), and evaluate benefits for participants by exploring commitment to the     program, opinions about healthy eating, retention of nutrition and food preparation     knowledge, overall takeaway from the program, as well as self-assessment of health status.      To establish the overall feasibility of an effective prescription produce program for     at-risk and underserved patients - called ProduceRx - by utilizing produce from regional     farms in addition to the resources of the Penn State Health System and an interdisciplinary     team of healthcare workers (dietitians, dietetic interns, and medical students).      To provide a proof-of-concept for this model (i.e. ProduceRx + interdisciplinary approach to     health education) for other healthcare institutions.   "
37498|NCT02794805|"     An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in     subjects with risk. The gold standard will be MRI.   "
37500|NCT02794779|"     Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in     Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage     because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses     threaten the life of women.      Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.      Method: adaptative clinical trial using a modified up and down method of two sequential     groups: rule of three and continuous infusion. Allocation in rule of three or continuous     infusion will be random and masked for patients and anesthesiologists. The minimum effective     dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).   "
37501|NCT02794766|"     Halitosis associated with tongue coating results from the production of volatile sulfur     compounds by bacterial action. The use of prebiotics and probiotics might be useful in     treating such condition. The aim of this study was to evaluate the effect of the prebiotic     inulin combined with the probiotic Streptococcus salivarius (SS) on halitosis by coating.   "
37502|NCT02794753|"     The principal aim of this study is to establish the impact of Cognitive Training in patients     with primary Hair-pulling Disorder. Half of the participants will be training with the true     training intervention and the other half with the active control intervention.      Study findings will also provide information on whether an internet based CT intervention,     done at patients' homes, is feasible as a mode of treatment for HPD patients in SA.   "
37503|NCT02794740|"     Primary Objectives:      To evaluate the safety and tolerability of escalating single and multiple doses of     Ibuprofenamine Hydrochloride spray administered as a topical application.      Secondary Objectives:      To characterize the single and and multiple pharmacokinetics of escalating doses of     Ibuprofenamine Hydrochloride spray and its active metabolite ibuprofen as a topical     application.   "
37504|NCT02794727|"     Decreased physical activity is not only associated with multiple chronic medical conditions,     including obesity, but also with depressed mood, and other negative emotions. As many     employed adults spend a great deal of time at work where we are predominantly sedentary,     strategies to increase physical activity at work are being pursued to help improve the     physical and mental health of Americans. This 17 week randomized controlled trial will     investigate changes of occupational physical activity in three groups: those provided with a     FitBit® but not able to monitor their activity level, and those provided with activity goals     and individual physical activity challenges, and those who do not use a FitBit®.   "
37505|NCT02794714|"     This study compares surgeon's satisfaction of operating conditions and patient's satisfaction     following laparoscopic gynecological surgeries in two groups of patients, half of whom will     receive deep neuromuscular blockade and the other half, moderate neuromuscular blockade.   "
37506|NCT02794701|"     Objectives: This study aims to explore the risk profiles among people with silicosis in Hong     Kong underpinned by the Pittsburgh Mind-Body Center model.      Design and subjects: This study will adopt a cross-sectional study design with sampling     stratified by participants' degree of incapability. 320 Chinese people diagnosed with     silicosis and registered with the Pneumoconiosis Compensation Fund Board will be recruited.      Data collection: A demographic data sheet and the St. George's Respiratory Questionnaire will     be used to collect the socio-demographic and clinical characteristics of the participants.     The behavioral factors (smoking, drinking, physical activity level, consumption of vegetable     and fruits and plasma vitamin C level) as well as the psychological risk factors (anxiety and     depressive symptoms, and social support) will be examined by validated questionnaires.     Biological and physiological parameters, including insulin resistance, C-reactive protein,     hemoglobin, fasting blood glucose and lipid profiles, will be ascertained by fasting blood     sample.      Data analysis and expected outcomes: The findings of this study will create the database     profile of the physical, psychosocial and disease specific aspects among people with     silicosis in Hong Kong, subsequently forming the empirical basis of an intervention to tackle     the identified modifiable risks among them.   "
37507|NCT02794688|"     RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of     idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators     hypothesized that ductal lavage is able to relieve the symptoms and achieve complete     response, with shorter recovery time than oral intake of antibiotics or corticosteroids     treatments. This single arm, observational, case series, pilot study is going to evaluate the     effectiveness of ductal lavage in patients with non-lactational IGM or PD.   "
37508|NCT02794675|"     The purpose of this study is to explore the use of a treatment called interstitial     brachytherapy for patients who have a high risk resectable (able to be treated with surgery)     recurrent head and neck cancer.      Brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them     into a specific place on your body. This study is using Cesium-131 permanent interstitial     brachytherapy.      Cesium-131 is FDA approve for brachytherapy use, however, there are currently no research     studies to show how effective it is for head and neck cancer. The goal of this study is     determine the effect that the placement of Cesium-131 brachytherapy seeds has on overall     survival as well as to assess possible side effects.   "
37509|NCT02794662|"     The purpose of this study is to determine if, in preterm infants < 37 weeks' gestation at     birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared     with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations     less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention.      This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to     oxygen environment or nasal cannula oxygen using stratified permuted block design. Following     a 24 hour period on the first intervention, infants will cross over to a 24 hour period on     the second (alternative) intervention before crossing back to the first intervention for a     further 24 hours and then back again to the second (alternative) intervention for a further     24 hours.   "
37510|NCT02794649|"     To characterize the microbiome in 4 groups of subjects (primary hyperoxaluria type I (PH1),     idiopathic CaOx stone, enteric hyperoxaluria (EH) and healthy participants) by comparing the     number of species and diversity of the microbial populations and pathway for oxalate     metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by     gut bacteria.   "
37538|NCT02794285|"     The purpose of this study is to characterise long-term safety and tolerability of intravenous     anifrolumab.   "
37512|NCT02794623|"     Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the     general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2     percent of the population. Tinnitus therapy is based on counselling, cognitive and     behavioural therapies in combination with sound therapies which mostly rely on masking.      For cochlear implant candidates, the ability to use hearing aids and maskers is limited by     the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67     to 100% with a mean of 80%.      In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use     of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs     when the implant is switched off. While the benefits of CI implantation on tinnitus are well     documented, there is a group of recipients where tinnitus remains a concern in the implanted     ear post-operatively.      The primary aim of this study is to investigate the benefits of using tinnitus masking via a     CI sound processor that optimises tinnitus suppression with minimal annoyance to the user.     Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of     tinnitus in recipients.   "
37513|NCT02794610|"     Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.      Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before     cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will     be subjected to detection of presence and level of tacrolimus.   "
37514|NCT02794597|"     Recent research suggests that women with substance use disorders may be at a higher risk of     unintended pregnancy. There is a paucity of interventions specifically focused on this     population. Through using mixed methods, this study proposes to develop a brief peer-led     intervention (based on the Health Belief Model) to prevent unintended pregnancies among women     entering opioid medication-assisted treatment; to assess acceptability, feasibility and the     initial efficacy of the behavioral intervention; and to conduct exploratory analyses to     identify the HBM constructs that are most influential on use of long-acting reversible     contraception methods. Future research would include testing the intervention in a larger     scale trial and with other populations.   "
37515|NCT02794584|"     Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations.     In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure     for pediatric VSD in the clinical practice, precision assessment of perioperative its     effectiveness and safety has already become an important issue that must be solved. On the     basis of echocardiography, integrating with characteristics associated critical care, the     investigators focus on precision assessment of perioperative effectiveness and safety of     transthoracic hybrid closure for pediatric VSD, compared with conventional surgical     sternotomy repair with cardiopulmonary bypass (CPB).   "
37516|NCT02794571|"     This first-in-human open-label, multicenter, dose-escalation study is designed to evaluate     the safety, tolerability, and PK of MTIG7192A alone or in combination with atezolizumab in     participants with locally advanced, recurrent, or metastatic incurable tumors for whom     standard therapy does not exist, has proven to be ineffective or intolerable, or is     considered inappropriate, or for whom a clinical trial of an investigational agent is a     recognized standard of care.   "
37517|NCT02794558|"     Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR     Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas   "
37518|NCT02794545|"     Although combination antiretroviral therapy (cART) can significantly reduce morbidity and     mortality, it still fails to eradicate HIV. Given the difficulty for eradication of HIV,     functional cure is more likely to achieve the goal. In recent breakthrough scientific     reports, there already existed several examples of HIV-infected cases achieving the status of     functional cure only through early administration of cART in newborns or early infected     cases. From Taiwan centers for disease control (CDC) reports and our clinical experiences,     more and more young men got HIV infection and the most important finding is the investigators     can find some of them are newly infected, let's say, within six months.   "
37519|NCT02794532|"     Pre-oxygenation with high-flow nasal cannula oxygen has been evaluated in a limited number of     studies and seems to be better than traditional preoxygenation with a tight fitting mask.     Oxygenation with high-flow nasal cannula in apnea demonstrates that this could be done safely     for up to 25 mins with preserved saturation. Based on this, the investigators want to     evaluate whether this novel concept of preoxygenation can prolong the time to desaturation in     emergency anesthesia while securing a possibly difficult airway. This may reduce the number     of hypoxic events during intubation. This novel concept has already been tested in clinical     practice in certain cases but not during rapid sequence induction for acute surgery.      Objectives and Purpose The general purpose of this project is to compare a new preoxygenation     technique based on humidified oxygen in a high-flow nasal cannula with traditional     preoxygenation with a tight fitting mask during rapid sequence induction intubation with     focus on gas exchange.   "
37539|NCT02794272|"     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a     decrease of GABA concentration and alterations of functional brain connectivity in older     people, compared to sham tDCS.   "
37540|NCT02794259|"     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a     decrease of GABA concentration and alterations of functional brain connectivity in older     people, compared to sham tDCS.   "
37601|NCT02793466|"     This clinical trial is the first clinical trial to study Durvalumab, a checkpoint inhibitor     which stimulates the patient's own immune system to act against cancer cells in children and     adolescents. This trial will assess the safety and tolerability of Durvalumab in children and     adolescents and also study how Durvalumab is processed in their bodies.   "
37854|NCT02790151|"     Memory deficits after brain damage are common and there is still a need for evaluated therapy     methods. In this study we compare two therapeutic interventions and investigate whether     therapy effects can be found on neuropsychological tests and on a test measuring memory in     everyday life.   "
37976|NCT02788565|"     Data from this study will contribute additional knowledge regarding patient outcomes and     direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic     countries. Such knowledge can be of importance in a treatment decision, decision support for     development of care, follow up and training of both patients and primary care nurses.   "
37520|NCT02794519|"     Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal     antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The     continuing unmet need in subjects with asthma refractory to corticosteroid therapy and     increased understanding of asthma pathogenesis have stimulated the development of targeted     biologics based on predictive biomarkers. The majority of approaches to date have targeted T     Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma     represents an unprecedented approach that has potential to address non-Th2 drivers of severe     asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled,     parallel group study will investigate the efficacy of sirukumab compared to placebo in     subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid     (ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable     treatment period for individual subjects. Dosing will continue every 4 weeks until week 44     (inclusive), or until 24 weeks after the final subject has been randomized, whichever the     sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16     week Follow Up period. Overall, the duration of participation for subjects who complete the     full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175     subjects will be randomized such that 140 evaluable subjects complete the study.   "
37521|NCT02794506|"     Background:      Propolis is a natural resin made by bees from various plant sources. Propolis exerts     antimicrobial, anti-inflammatory, immunomodulatory, antioxidant, and antidiabetic properties.     The purpose of this study was to assess the adjunctive benefit of propolis supplementation in     individuals with both chronic periodontitis and type 2 diabetes mellitus (T2DM) receiving     scaling and root planing (SRP).      Methods:      A 6-month randomized blinded clinical trial comparing SRP with placebo (placebo+SRP group,     n=26) or combined with a 6- month regimen of 400 mg oral propolis once daily (propolis+SRP     group, n=26) was performed in patients with long-standing T2DM and chronic periodontitis.     Treatment outcomes included hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), serum     N€-(carboxymethyl) lysine (CML) and changes in periodontal parameters.   "
37522|NCT02794493|"     RATIONALE: Hand foot syndrome may be treated or reduced by soaking Traditional Chinese     Medicine Formula LC09 in patients receiving capecitabine for colorectal and/or breast cancer.      PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine     Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome     in patients who are receiving capecitabine for colorectal or breast cancer.   "
37523|NCT02794480|"     The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA     Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject     with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK     MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over     study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler     use. No active drug will be used in this study in order to prevent any drug-related effects.     Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be     randomized to receive one of the MDI inhalers, for use during the first period (P)     (approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI     will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in     the previous period will receive the ELLIPTA DPI for use during second period (approximately     28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue     albuterol MDI during the entire 56-day study period.      ELLIPTA is a registered trademark of the GSK group of companies.   "
37524|NCT02794467|"     The primary objective of the study is to assess the efficacy, safety, and tolerability of     epelsiban compared with placebo in treatment of women with adenomyosis.      This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an     interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of     epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be     composed of three periods: screening, treatment, and follow-up and the total time a subject     will be in the study will be approximately 6 months.   "
37525|NCT02794454|"     Sexual function is a part of a normal healthy life and considered to be essential for mental,     physical and marital well-being. Any derangement in normal function though is a distressing     situation for the individual, is often not reported due to embarrassment or due to social     stigma. Sexual disorders in men are categorized according to the stage of sexual response     affected in terms of disorders of erectile function, ejaculatory function or libido, albeit     there is considerable potential for overlap amongst the disorders. The use of current     intervention has many side-effects and has been prohibited in cardiovascular condition and     also to be taken with caution with other medical condition.      This has led to the development of multiple alternate therapies which are helpful for a     limited number of cases but the major concern for all these therapies is their late onset of     action and not having a sustained effect.   "
37526|NCT02794441|"     Migraine recurrence is common amongst pediatric patients being discharged from the emergency     department after treatment for migraine. Despite the commonality of migraine recurrence     within the week following discharge, no known effective therapies are available in the     pediatric population, though dexamethasone has been established as efficacious in the adult     migraine population. The proposed study will randomly assign children and adolescents     visiting the emergency department (ED) for migraine to receive either one dose of oral     dexamethasone or oral placebo. Twenty patients will be recruited to this randomized,     double-blind, pilot trial over a 6 month period, and the aim of the study will be to     determine the feasibility and acceptability of the protocol.   "
37527|NCT02794428|"     A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO)     in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk     regions of Latin America.   "
37528|NCT02794415|"     The primary aim of this research is to evaluate a community-based exercise (CBE) intervention     for adults living with HIV within the community with the goal of reducing disability and     enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive     outcomes) and contextual factor outcomes (social support, stigma, mastery, coping) for adults     living with HIV.   "
37529|NCT02794402|"     Combat-JUDO (Combating Juvenile Diabetes and Obesity through normalization of beta-cell     function) is part of a collaborative project funded by the Seventh Framework Programme of the     European Commission aiming to develop innovative therapeutic strategies by increasing     pharmacology-based alternatives targeting insulin hypersecretion for the treatment of young     obese individuals.      The prevalence of childhood obesity is ranging between 5-25% in Europe. The reason behind     these alarming figures is mostly a changing environment with a more sedative lifestyle and     supply of excess food. However, specific gene mutations have also been linked to obesity and     new genes are continuously being discovered. There are very few effective means of     intervention in children with obesity available today. Obesity is closely associated with a     number of related metabolic diseases and some children with obesity develop the metabolic     syndrome at an early stage in life. Individuals with obesity have an increased risk of     developing type 2 diabetes mellitus (T2DM) and with the current increase in childhood     obesity, some children will develop T2DM already in their adolescent years with huge impact     on their long-term health and life expectancy.      Lifestyle modification interventions, including behavioural treatment, diet modification and     physical activity, are cornerstones of primary and secondary prevention/treatment of     pediatric obesity today. Exenatide is a GLP-1 (glucagon-like peptide-1) receptor agonist     approved for use in adults with T2DM to improve glycemic control. A pilot study with     exenatide treatment in non-diabetic children and adolescents with severe obesity showed a     reduced BMI of approximately 5% and improved markers of insulin resistance and β-cell     function were observed.      The Combat-JUDO study is a parallel, double-blind, randomized study comparing lifestyle     intervention + exenatide 2 mg vs lifestyle and intervention + placebo in adolescents with     obesity. The lifestyle intervention includes regular nutritional and psychological support at     4 occasions during the study as well as physical activity on a weekly basis.     Exenatide/placebo is given as a subcutaneous injection once weekly for 24 weeks. The primary     objective of the study is to compare the change in BMI-SDS (according to WHO) from baseline     to the 6 months visit between the two treatment arms.      The study includes males and females of age 10-18 years and 5 months with BMI SDS >2.0 or     age-adapted BMI >30 kg/m2.   "
37530|NCT02794389|"     The investigators will examine whether compulsivity in those who score above-average (but     below clinical cut-off) on an eating disorder questionnaire can be altered by 9 days of     N-acetyl cysteine (NAC). N-acetyl cysteine has been shown to be of some benefit in     individuals with other compulsive disorders, such as trichotillomania and addiction, so this     research investigates whether a short period of time taking N-acetyl cysteine changes     compulsivity, measured using cognitive tasks and questionnaires.   "
37531|NCT02794376|"     This study investigates the effectiveness of a 6 week mindfulness intervention in reducing     symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment.     Participants will be randomly allocated to an immediate treatment group and a waiting list     control group.   "
37532|NCT02794363|"     15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic     specializing in vulvar disorders. This study consists of a 2 week screening period and a     12-week treatment period. Participants will receive two separate treatments of autologous     platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after     the second autologous platelet rich plasma injection   "
37533|NCT02794350|"     The cognitive profile of older adults with a severe to profound hearing impairment is     determined by means of the Repeatable Battery for the Assessment of Neuropsychological     Status, adjusted for Hearing impaired subjects (RBANS-H) before and after cochlear     implantation. In this prospective, longitudinal study the participants are tested     preoperatively, at six months and twelve months postoperatively and from then on yearly up to     10 years after implantation. In addition to the RBANS-H an audiological examination and an     semistructured interview is conducted concerning the cochlear implant use and the     self-reliance of the patient and subjective questionnaires are filled out by the subjects to     assess quality of life and hearing benefit.   "
37534|NCT02794337|"     Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable     disease. In the last decade results of randomized trials and a subsequent metaanalyses     established transarterial chemoembolization (TACE) or systemic chemotherapy (sorafenib) as     standard of care. However, TACE alone is not a curative approach. The two year survival     following TACE ranges from 31-63% with almost 100% patients developing disease progression     after treatment. There is need to investigate additional therapeutic options that would     consolidate the initial response to TACE. A recent metaanalyses concluded that addition of     high dose radiation to TACE results in 10-35% improvement in two year overall survival.     However as results of metaanalyses were based on studies with small sample size, unclear     randomization procedure and heterogenous dose of radiation, the need for conducting a high     quality randomized study was highlighted The present study is designed to investigate the     role of high dose conformal radiation as consolidation therapy after TACE in patients with     nonmetastatic unresectable HCC.   "
37535|NCT02794324|"     Radiotherapy (RT) has a major curative role in women with early breast cancer, and is     recommended routinely after lumpectomy and selectively after mastectomy. It has contributed     to a halving of breast cancer mortality in the UK over the last 2 decades despite ever-rising     cancer incidence. RT in women with left-sided tumours often exposes the underlying heart to a     damaging dose. The heart is very sensitive to RT, and there were 1-2 deaths from heart     disease for every 100 breast cancer patients treated during the 1960s-70s. The situation has     improved in recent years, but standard RT techniques still deliver significant radiation     doses to heart tissue.      Two potentially simple techniques reduce heart dose. In one, women are taught to breathe in     deeply and to hold their breath for about 20 seconds while RT is given. The downward movement     of the diaphragm pulls the heart away from the RT beam. In the other technique, women lie on     their fronts, instead of on their backs as they normally do for breast RT. In this position,     the breast falls away from the rib cage and reduces exposure of the heart. Neither technique     is routinely available to women receiving breast RT in the UK for reasons that this research     aims to address. The investigators need to: 1) confirm that patient position can be     reproduced with millimetre precision every day using these techniques, 2) minimise costs of     equipment, time and personnel required to support such techniques, 3) select the most     appropriate technique for different patients and 4) train staff in centres across the UK to     deliver techniques safely and effectively. By addressing all of these issues, the study aims     ultimately to make heart-sparing RT available to all UK women that might benefit from     treatment, thereby significantly reducing the burden of heart disease in breast cancer     survivors.   "
37536|NCT02794311|"     The purpose of this study is to specify the psychological, cognitive, neuro-functional and     genetic profile associated with binge drinker behaviors among young adults. Results will help     identifying more precisely vulnerability factors associated with this pattern of alcohol     consumption and guiding prevention efforts.   "
37537|NCT02794298|"     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a     decrease of GABA concentration and alterations of functional brain connectivity in younger     people, compared to sham tDCS.   "
37541|NCT02794246|"     This will be a single-arm, open-label study. Patients will be enrolled during induction     therapy for multiple myeloma, prior to standard-of-care consolidation with autologous stem     cell transplantation (ASCT). T cells will be harvested for T cell manufacturing prior to     ASCT, and CART-19 will be infused at day ~60 post-ASCT, 3 days after lymphodepleting     chemotherapy. The primary endpoint is progression-free survival (PFS) after ASCT. As detailed     below, the study is powered to detect an increase in two-year PFS to ~75% from a baseline     expectation of 55% based on historical data. Secondary endpoints will evaluate CART-19     persistence and function, minimal residual disease, immune correlative endpoints, and     associations of progression-free survival (PFS) with CART-19 persistence and clinical and     biologic characteristics of multiple myeloma.   "
37542|NCT02794233|"     The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in     patients of Parkinson disease (PD) as a function of their functional state (lying, sitting     and walking) and dopaminergic medication intake (levodopa or dopamine agonists).      The goal is to use DBS measured impedance as a surrogate of the functional and medication     states of PD patients.   "
37543|NCT02794220|"     The purpose of this study is to assess the amount of nicotine that is absorbed into the blood     stream following the use of a new Electronic Cigarette device called the CN electronic     cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared     to the amount of nicotine delivered from smoking a regular cigarette and from using the     Nicorette® Inhalator.      Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering     nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful     combustion products contained in tobacco smoke.      Electronic cigarettes are readily available in many markets, and may contain significant     quantities of nicotine. However, they are not regulated as medicines, and their manufacturers     can make no medicinal claims about them.      Such products are unregulated, having not been subjected to regulatory review by either the     Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body.      It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an     application to the MHRA for the CN Electronic Cigarette, in order to make a high quality,     regulated product available. Males aged 18-65, who smoke and who have no intention of     stopping smoking during the trial are eligible to take part in this study. The study consist     of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on     days 1, 2, 3 and 4 with a post study visit on day 5.   "
37544|NCT02794207|"     The primary objectives of this study are to identify what outcomes related to the management     of neutropenia are most important to children with AML and their caregivers. Patients who     have completed treatment for AML and their caregivers will be interviewed in order to better     understand the impact of neutropenia management on children with AML and their families. The     primary outcome of these interviews is to identify patient-centered outcomes related to     neutropenia management to include in a subsequent comparative-effectiveness analysis.     Investigators will use these data to develop a structured survey for administration to     prospectively identified patients in subsequent studies.   "
37545|NCT02794194|"     After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual     symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint giving     away or decreased function. Recently, Whole Body Vibration (WBV) training has been     introduced as a preventive and rehabilitative tool. It can be hypothesized that WBV on     unstable surfaces might enhance neuromuscular control. Therefore, the aim of this study was     to investigate the effects of a 6-week WBV training on an unstable surface on body     composition, balance, strength and reflex and muscle activity of ankle muscles in     recreational athletes with CAI.   "
37546|NCT02794181|"     Background:      Zika virus is mostly passed on by the bite of an infected mosquito. It usually causes mild     illness. But in pregnant women it can cause serious birth defects to the baby. The virus can     also spread by blood transfusion and sexual intercourse. This is why the U.S. Food & Drug     Administration (FDA) recommended that people should not give blood if possibly exposed to     Zika virus. Dengue virus and chikungunya virus are passed by the same mosquitoes as Zika     virus. These can cause severe reactions if passed through transfused blood.      Donated blood is usually not tested for these three viruses. Researchers want to count the     infections in people who have been exposed because of travel or sexual exposure. They want to     learn the risk these viruses might pose to the U.S. blood supply. They also want to study the     natural history of these viruses by following infected people over time.      Objective:      To study the risk of Zika, dengue, and chikungunya viruses to the U.S. blood supply.      Eligibility:      Adults age 18 or older who were turned down for donating blood because of possible exposure     to certain viruses.      Design:      Participants will have blood and urine tests. They will answer questions about their travel.      They will be called in about a week with virus test results.      Participants with negative results do not have any more study visits.      Participants with positive results will be asked to stay in the study for 6 months. They will     have weekly clinic visits and tests until results are negative for 2 straight weeks. Once     test results are negative, they will have monthly visits. Visits will include physical exams,     blood and urine samples, and optional semen samples from men.      Most people will have 3-4 weekly visits and 5 monthly visits....   "
37547|NCT02794168|"     This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome     in patients with moderate and severe traumatic brain injury. Half of the participants will     receive Ronopterin (VAS203), while the other half will receive placebo.   "
37566|NCT02793921|"     This randomized control trial will examine whether a well-controlled and monitored site-based     exercise intervention, initiated before beginning aromatase inhibitor (AI) therapy, improves     cognitive function in postmenopausal women with early-stage breast cancer and will explore     whether neuroimaging metrics of brain health, pro-inflammatory biomarkers and symptoms     (fatigue, sleep problems, depression, anxiety) mediate the effects of exercise on cognitive     function. Furthermore, the study will explore whether the magnitude of the improvements in     cognitive function are modified by estradiol levels.   "
37567|NCT02793908|"     The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone     (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day;     Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction     in patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time     intercourses or COS/IUI cycles.   "
37548|NCT02794155|"     This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study,     evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro     Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be     randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in     an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the     randomized treatment in combination with glargine or detemir. Goal to demonstrate that the     efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin     Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin     Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If     non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal     insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal     insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4%     decrease in HbA1c).   "
37549|NCT02794142|"     In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has     previously been reported. This muscle impairment constitutes an independent prognosis factor     in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment.     The mitochondria is a classical producer and target of reactive oxygen species (ROS), and may     thus constitute a central actor of the skeletal muscle impairment in HD patients. Therefore,     the aim of the present study is to investigate the role of the muscle mitochondrial density     on the muscle impairment in HD patients, in comparing the muscle mitochondrial density and     oxidative stress in HD patients vs. healthy matched controls.      In order to assess the effect of the oxidative stress and inflammation on the muscle     impairment in HD patients, muscle function assessements will be performed after renal     transplantation (which lowers the oxidative stress and inflammation levels) in the HD patient     group.      No therapeutic intervention will be tested in the present study.   "
37550|NCT02794129|"     Bipolar disorder is a mental disease characterized by mood dysregulation and arises from     manic, depressive or mixed episodes. The observations of the patient's speech and language     behaviour due to flight of ideas or loss of goal probably result from an underlying     disturbance in semantic networks dealing with semantic associations. The aim of our study     will be to have a better comprehension of thought disorders in bipolar disorder by cognitive     exploration of semantic processing.   "
37551|NCT02794116|"     Aim: To evaluate the clinical survival of fluoride sealants applied in first permanent molars     affected by Molar-Incisor Hypomineralization (MIH).      Material and Methods: For this case control study, it was selected 41 first permanent molars     of the 21 children aged 6-8 years. MIH was classified by one calibrated examiner (kappa 0.80)     according severity of the MIH lesion (EAPD, 2003). Inclusion criteria were FPM with MIH or     sound (without MIH), fully erupted, and with sealant treatment indication.      The FPMs were assigned into two groups: G1 - Control group and G2 - MIH group. Both group     teeth were treated with sealant application (Fluroshield, NY, USA). Clinical follow-up was     performed at baseline, 1, 6, 12 and 18 months for anatomic form, marginal adaptation,     retention and presence of caries, according to the United States Public Health Service     USPHS-Modified by a blinded examiner (kappa 0.80). The Acturial Method was used to evaluate     the survival of sealants. Statistical analysis compared the ratings of each criterion between     materials using the Fisher's exact test at a level of significance of 5% (p<0.05).   "
37552|NCT02794103|"     Procedural pain is the most intense and often undertreated pain associated with burn     injuries. The use of analgesics does not always provide optimal relief and is accompanied by     several side effects. Indeed, children with burn injuries still experience severe pain     intensity during procedures despite the fact that doses of analgesics used with this     population has almost doubled in the last twenty years. Current guidelines on pediatric     procedural pain management recommend the combination of non-pharmacological and     pharmacological interventions to enhance pain management and decrease the numerous side     effects of analgesics. Distraction has been identified among the most effective     non-pharmacological interventions for pain as it diverts the child's attention to an     attractive element, hindering the perception of the painful stimuli. Virtual reality is a     method of active distraction that offers the child a multi-sensory immersive interaction that     found many applications for pain management in adult patients. However, very few studies have     tested the efficacy of distraction by virtual reality on procedural pain and anxiety in     children with burn injuries.      The aim of this study is to assess the feasibility and preliminary efficacy of a virtual     reality prototype developed specifically for the hydrotherapy room of children under seven     years old for the relief of procedural pain and anxiety in children with burn injuries.     HYPOTHESES: a) VR distraction is a feasible non-pharmacological intervention for pain     management during hydrotherapy, b) VR distraction combined with analgesics is more     efficacious than standard treatment (analgesics alone) on procedural pain and anxiety     (hydrotherapy) of young children with burn injuries.   "
37553|NCT02794090|"     This study evaluates if usual physical care visits to an outpatient pediatric clinic can be     replaced with more frequent and shorter Telephone coaching Contacts during 18 months.   "
37554|NCT02794077|"     There is no standard third-line systemic treatment for inoperable locoregionally advanced     recurrent or metastatic nasopharyngeal carcinoma (NPC). We investigated the efficacy and     safety of metronomic oral cyclophosphamide as third-line treatment or beyond.   "
37585|NCT02793674|"     High-flow nasal cannula (HFNC) is a method of non-invasive respiratory support used to     decrease the effort of breathing (EOB) in patients with a wide variety of respiratory     diseases in the pediatric intensive care unit. While its use has shown association with     decreased rates of mechanical ventilation, there is a paucity of data examining its direct     effect upon objective measurements of EOB. This study will aim to evaluate objective     measurements of EOB in response to different levels of HFNC support, characterize the natural     course of respiratory diseases treated with HFNC, evaluate changes in EOB secondary to the     administration of supplemental medical therapies used in conjunction with HFNC, and compare     different physiologic metrics for quantifying EOB in patients on HFNC.   "
37586|NCT02793661|"     The Strength study aim to evaluate the use of the RenalGuard device to protect the patients     at high risk to develop acute kidney injury following a complex cardiovascular intervention     requiring a high volume of contrast.   "
37555|NCT02794064|"     Breast conservation surgery (BCS) is performed on patients with breast cancer with the intent     to resect and completely remove the tumour while conserving as much of the surrounding normal     tissue as possible. Currently, there is no way for surgeons to determine the adequacy of     surgical resection in real-time during surgery; the assessment of surgical margins requires     histological examination that is not available in real-time and is impractical in most     clinical cases. This results in a re-excision rate of 23% among Canadian women in order to     achieve optimal surgical margins. In addition, the presence or absence of cancer in tumor     draining lymph nodes is recognized as a key element for breast cancer staging; however, lymph     node dissection can be associated with overtreatment and morbidity (nerve damage and post     surgical lymphedema) and histological analysis of nodes can be time consuming and thus delay     subsequent procedures. In an effort to address these issues, we have designed and     constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system     that performs three complementary imaging modalities (tri-modal): ultrasound (US),     photoacoustic (PA) and fluorescence (FL).      This first-in-human pilot study will recruit 10 breast cancer patients undergoing breast     conserving surgery at Princess Margaret Hospital (Toronto, Canada). The study is designed to     test our tri-modal (US, PA, FL) imaging technology in breast cancer patients. The overall     goal is to obtain initial information on the technical feasibility of the tri-modal system in     a peri-operative setting and to confirm the anticipated safety of the procedures.     Additionally, it will provide initial data on the ability of this system to detect/localize     primary breast cancer lesions and cancer-involved lymph nodes prior to surgery.   "
37556|NCT02794051|"     This study fills a notable gap in the transdiagnostic literature by evaluating whether an     evidence-based transdiagnostic treatment for emotional disorders such as the Unified Protocol     for Children (UP-C) is effective for treating childhood behavior problems.   "
37557|NCT02794038|"     This study scope is to validate the accuracy and usability of the Soberlink Cellular Device     in comparison to a predicate device, BACtrack S80 Pro.   "
37558|NCT02794025|"     The purpose of this study was to investigate the effect of esmolol on hemodynamic     parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis   "
37560|NCT02793999|"     The purpose of this study is to improve the ability of the investigators to monitor brain     health in newborn babies at risk of brain injuries. The researchers will be using an     investigational system of devices to non-invasively (that, is, without penetrating the skin),     measure the amount of oxygen going to and being used by the brain. They will be taking some     bedside research measurements during the babies' stay at the hospital. With these     measurements, the intention is to study the role of oxygen in brain injury and test the     efficacy of the research device and its potential as a permanent bedside diagnostic device.   "
37561|NCT02793986|"     With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To     offer an satisfied surgery process for patients, a proper sedation is necessary. So in this     study, we want to investigate the influence of two different sedative drugs on outcomes of     patients received hip replacement surgery .   "
37562|NCT02793973|"     A structural leg length discrepancy (SLLD) is a common clinical problem. Its prevalence has     been estimated at 40-70%. Those who have been suffered from limping for a long time may lead     to follow-up low back pain and lower limb musculoskeletal disorders. Although lower limb     triple view of x-ray is considered to be the current technique for determining LLD, it is     costly and time consuming that not every hospital can afford it, and in case of radiograph,     the patient is exposed to radiation. Therefore, it is necessary to develop a rapid clinical     assessment method by gathering exterior parameters to build up a Regression model for     measuring the discrepancy and determining LLD accurately.      While using shoe lifts to correct discrepancy is the easiest conservative intervention for     LLD, there are still many controversies on how much height should be added clinically and     academically. The optimal height should be added depends on feedbacks from users and gait     performance. The best gait performance can be measured from kinematic performance of center     mass of body during walking. Therefore, this project wants to compare treatment responses     between two kinds of shoe lift height correction methods for LLD: given 80% discrepancy in     shoe lift height correction through triple view of x-ray and given optimal shoe lift height     correction through analyzing kinematic performance of center mass of body.   "
37563|NCT02793960|"     This is a single-center study to investigate the effects of a topical cream on patients 12     years of age and older that have been diagnosed with epidermolysis bullosa.   "
37564|NCT02793947|"     The purpose of this study is to determine the efficacy and safety of a peri-incisional     multimodal injection for post-operative pain control following operative management of femur     fractures. Enrolled subjects will be prospectively randomized into either the peri-incisional     injection or control cohorts. Patients will be treated with standard of care surgical     techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern.     The patients randomized into the injection cohort will receive an intra-operative injection     with 400 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and     deep peri-incisional tissues while under general anesthesia. Visual analog pain scores will     be collected every 4 hours after surgery for the first two post-operative days. Total     narcotic consumption will also be recorded over eight hour intervals for the first two     post-operative days. Medication related side effects will be monitored. The investigators     hypothesize that the peri-incisional injection cohort will demonstrate an improved pain     profile and utilize less parenteral narcotic analgesia in the early post-operative period.   "
37565|NCT02793934|"     The Programme is focused on adult patients of any gender and age more than 18 y.o., with the     next conditions:        1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage -          specialty neurology)        2. Acute myocardial infarction (AMI, specialty cardiology)        3. Patients after total hip replacement (THR, specialty orthopaedia) The program is          performed in the in-patient and out-patient rehabilitation departments in 13 regions of          the Russian Federation (total 244 departments).   "
38016|NCT02788045|"     The purpose of this study is to assess the safety/tolerability of the 2 different vaccine     regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and     Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with     Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the     different vaccine schedules will be assessed.   "
37568|NCT02793895|"     The aim of the SEARCH-AF trial is to evaluate a novel diagnostic tool for detecting     post-operative atrial fibrillation or flutter (POAF/AFL) in cardiac surgical subjects during     the early, sub-acute post-operative period. The population includes cardiac surgical subjects     who have either developed or are at risk for developing new onset POAF/AFL and who are at     risk for stroke, as determined by their CHA2DS2-VASC (congestive heart failure, hypertension,     age ≥75 years (2 points), diabetes mellitus, previous stroke/transient ischemic attack (TIA)     (2 points), vascular disease, age 65-74 years, sex class (female)) score. These subjects must     not have had a history of AF/AFL before cardiac surgery.      The intervention group will undergo 30 days of continuous cardiac rhythm monitoring with an     adhesive, patch-based monitor (Medtronic SEEQ™ mobile cardiac telemetry system). The control     group will receive usual care, which does not involve planned cardiac rhythm testing within     the first 30 days after study randomization. The primary outcome is documentation of     sustained atrial fibrillation or flutter within the first 30 days after randomization. In     addition, subjects in both groups will undergo 14 days of continuous cardiac rhythm     monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system at 6±1 months after their     index cardiac surgery.   "
37569|NCT02793882|"     1.0 Background & Introduction Positron emission tomography / computer tomography (PET/CT) is     a nuclear medicine procedure based on the measurement of positron emission from radiolabelled     tracers. This technology allows biologic processes to be visualized and measured on whole     body images. Common radiotracers in use today in the USA and Europe are radiolabelled choline     derivatives such as the analogs 18F-fluoromethylcholine (FMCh) and 18F-fluoroethylcholine     (FECh), or more broadly FCH. Both of these fluorinated choline analogs have been extensively     studied and display seemingly identical biological, radiopharmaceutical and radiochemical     properties. Both have been extensively studied in human prostate cancer, with FMCh having     slightly more published data than FECh. Imaging with radiolabelled choline derivatives is     used to determine sites of abnormal choline metabolism and can be used to characterize     prostate cancer, for which there is extensive data in the literature. PET/CT with     radiolabelled choline derivatives is considered standard of care by some experts where     available, however at the JGH, anatomic imaging with CT and MRI, and bone scan are the     current diagnostic imaging modalities in use for this patient population. Prostate cancer     cells have increased choline uptake compared to normal tissues, forming the molecular basis     for this technique. The Gleason score, a histopathologic measure of tumor aggressiveness, is     one of the most important prognostic factors in the disease. The objective of this study is     to evaluate if the degree of uptake measured by maximum standard uptake value (SUVmax) on FCH     PET/CT in prostate cancer correlates with Gleason score at initial biopsy.      2.0 Study Objectives The objective of this study is to evaluate if the patient-wide SUVmax on     18F-FCH PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic     Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively     with Gleason score. This is of interest because non-invasive risk stratification may be     possible in the future.      3.0 Study Design This will be a single-site JGH-only open label study in which one (1)     18F-FCH PET/CT will be performed on study participants. A PET/CT scan takes about 3 hours.      4.0 Safety & Ethics The radiation dose to patients from fluorinated choline derivatives     compares favorably to the major PET tracer in widespread clinical use, 18F-fluorodeoxyglucose     (18F-FDG). The safety of fluorinated choline derivatives is not disputed and the     investigators expect the number of adverse events in this study to be at (or near) zero.     There is no established toxicology for diagnostic doses of fluorinated choline derivatives.      There are no salient ethical considerations identified. The treating physicians are free to     order any diagnostic or therapeutic intervention on study patients, and care will not be     modified or restricted in any way. Treating physicians are free to incorporate information     acquired with this study or discard it if it is not relevant. Care of the patients may be     improved with additional information provided by FCH PET/CT, but it is otherwise unchanged.     No vulnerable populations will be included in the study.      5.0 Confidentiality All information (medical history, physical examination, and PET/CT     results) will be kept strictly confidential and only authorized personnel will have access.     The reports of the PET/CT will be contained in a password protected radiology & nuclear     medicine RIS database (RadImage) where all other diagnostic imaging reports are securely     stored. Clinical PET/CT reports will be stored indefinitely, whereas all other study data     will be kept locked by the PI and destroyed after 10 years.      6.0 Population, Sample Size and Recruitment A maximum of 225 competent adult male medically     stable prostate cancer patients with available Gleason Scores will be entered into the study.     Patients will be recruited by urologists in the clinical setting. Initial contact and consent     will be by the department of urology.   "
37570|NCT02793869|"     Congenital cataracts (CC) are the leading cause of childhood visual disabilities and     treatable childhood blindness worldwide1. CC patients have a wide range of presentations of     lens opacities and are generally categorized into several groups based on the etiologies,     anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also     frequently complicated with other anterior segment abnormalities due to their close     anatomical relationships and similar developmental origins. Lens opacities in different     positions may be related to specific anterior segment abnormalities; for example, anterior     polar cataracts are associated with greater corneal astigmatism (CA). However, no studies     have systematically related the position of lens opacities to specific anterior segment     abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a     lack of awareness of these important relationships.   "
37571|NCT02793856|"     This study will evaluate the safety of PD-1 knockout engineered T cells in treating     metastatic non-small cell lung cancer. Blood samples will also be collected for research     purposes.   "
37572|NCT02793843|"     Background: Common adverse side effects related to the use of neuraxial opioids in the     obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor     antagonists, in particular ondansetron, have been identified as possible antipruritic agents.     It was reported that dexamethasone plus ondansetron is more effective than ondansetron for     prevention of postoperative nausea and vomiting but no additional effect on treating     pruritus.      Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron     versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative     nausea and vomiting (PONV).      Methods: A prospective randomized double blind study that will be conducted between June 2016     and June 2017. Patients will be randomly allocated into two groups. The first group will     receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV     ondansetron plus 8 mg dexamethasone.   "
37573|NCT02793830|"     This study evaluates the feasibility and acceptability of using mobile applications to     improve medication adherence. Participants in the experimental group will receive educational     materials and daily reminders through mobile applications. While, participants in the control     group will receive only educational materials. After the intervention, interviews will be     conducted among participants through phone calls.   "
37574|NCT02793817|"     The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0%     ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.   "
37575|NCT02793804|"     This study consists of a Cluster Randomised Trial (CRT) of community and facility-based HIVST     distribution by the Society for Family Health (SFH) in multiple rural and peri-urban     settings. The study will take place in 6 matched pairs of health facilities and their     catchment areas have been selected for study inclusion in collaboration with the district     medical office (DMO). One clinic catchment area from each pair will be randomly allocated to     the HIVST arm (intervention) and the other to the standard of care (SOC) arm (Control).In the     HIVST arm, community-based distribution agents (CBDA), including Voluntary Medical Male     Circumcision (VMMC) mobilisers, will deliver HIVST kits. The kits will also be available at     the health facility. In the SOC arm, all HIV testing and counseling (HTC) services will be     conducted as currently.   "
37576|NCT02793791|"     The aim of this study is to determine that for hepatic dysplastic nodules in patients with     chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive ablation     therapy can reduce the incidence of hepatocellular carcinoma.   "
37577|NCT02793778|"     The purpose of this study is to evaluate CROWN's efficacy in supporting the repair and     maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's     Disease receiving anti-Tumor Necrosis Factor (TNF) therapy (infliximab, adalimumab,     certolizumab)   "
37587|NCT02793648|"     The trial aims to treat depression. The incidence of major depression in the elderly accounts     for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in general is     studied. Besides depression in the elderly presents with cognitive impairment, impaired     physical and social functioning, and predisposes to suicide. These are patients who often     have multiple conditions and be taking numerous psychopharmacological treatments which     hinders further treatment. The clinical trial will analyze the improvement in     neuropsychiatric symptoms through different instruments The Beck Depression Inventory (BDI),     State-Trait Anxiety Inventory (STAI), Life Events (AV), World Health Organization Disability     Assessment Schedule 2.0 (WHODAS 2.0), Wechsler Memory Scale (WMS-III), Mini mental state     examination (MMSE), Clinical Global Impression (CGI) and metabolic changes in the blood test     measurements; after 12 weeks of antioxidant (Ascorbic acid and Tocopherol) treatment or     placebo, and then after 24 weeks on active treatment with the antioxidant combination     (Ascorbic acid and Tocopherol).   "
37632|NCT02793063|"     The purpose of this study is to explore the patient perspective of disease burden in     Osteogenesis Imperfecta (OI). Participants will complete a web-based survey of questions     which are usually administered within the Patient-Reported Outcome Measurement Information     System (PROMIS) and provide feedback regarding the appropriateness of the questions for     someone with OI.   "
37578|NCT02793765|"     This clinical study will evaluate the role of combination therapy of docetaxel followed by     Provenge for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate     cancer that is resistant to medical or surgical treatments that lower testosterone). The     purpose of this study is to look at the combination therapy of docetaxel followed by Provenge     to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are     genes, proteins and other molecules that affect how cancer cells grow, multiply, die and     respond to other compounds in the body. The study drugs are approved by the Food and Drug     Administration (FDA).      Treatment will be administered on an outpatient basis. Patients will receive 6 cycles of     docetaxel followed by Provenge. Docetaxel is an antineoplastic (chemotherapy that affects     cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour     infusion every 21 days on Day 1 for 6 cycles. Provenge is an immunotherapy (vaccine made from     patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy     consists of three doses of Provenge administered at 2-week intervals.      The strategy aims to determine whether cytokine production and T cell infiltration of tumor     cells could favor regression using a combination of chemotherapy plus vaccine. Tissue     endpoints will include biopsies prior to first chemotherapy and first vaccine therapy and at     the end of each therapy. Prostate cancer tissue infiltrates will be studied for expression of     CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints     will be secondary antigen spread and various cytokine biomarkers.   "
37579|NCT02793752|"     The need for non-invasive biomarkers of oocyte competency has become urgent as women     increasingly delay attempts at childbearing. The aging process is complex and includes     impaired mitochondrial dysfunction, oxidative stress, diminished metabolic activity, and     activity of several cell-signaling systems. Cumulus cells form an intimate association with     the oocyte in the follicle, and they can have a significant impact on oocyte meiotic and     developmental competence. In the IVF lab, the clump of cumulus cells is typically cut away     from the oocyte immediately after an oocyte retrieval procedure, and then the cumulus cells     are discarded. Measuring the mitochondrial respiratory activity of cumulus cells may serve as     a non-invasive biomarker for oocyte competency and a predictor of reproductive success in IVF     patients in the future.   "
37580|NCT02793739|"     Fingers are a part of the body that are often subject to increased signs of aging due to     physical use, trauma and exposure to the environment. The FDA's recent approval of a dermal     filler, calcium hydroxylapatite, in hands has led to increased patient demand for hand     fillers which, in turn, has led to the question of rejuvenation of the dorsal fingers. Due to     the different anatomy of the fingers than the dorsal hand plus the new demand to improve the     entire hand plus the finger area, we aim to characterize the best approach. Youthful fingers     are devoid of wrinkles and often have fuller contours thus hiding the knuckles (proximal     and distal interphalangeal joints). With aging and loss of subcutaneous tissue volume,     fingers become wrinkled, look more skeletal, almost emaciated, and joints become much more     prominent, all aesthetic features often disliked by patients. By augmenting the volume in the     dorsal fingers, it is possible that the visibility of such bony structures will be decreased,     wrinkles will become smoother, and a more youthful appearance of the fingers will be     restored.      There have been no published reports, to these investigators' knowledge, of the use of     injectable filler into the dorsal fingers for three-dimensional volume correction. The use of     exogenous hyaluronic acid (HA) filler in the fingers would be off-label. Given that HA filler     has been used safely and effectively in many areas of three-dimensional volume restoration     throughout the body, the investigators believe the HA filler may be used to effectively and     safely correct volume loss in the fingers. The investigators hope that this study will     present current, state of the art, never before reported technique, safety, efficacy and     patient satisfaction of HA filler in this region.   "
37581|NCT02793726|"     Symptomatic and asymptomatic patients wearing Metal on Metal hip prosthesis will be enrolled     in the study and periimplant pseudotumors will be searched by means of NMR (Nuclear Magnetic     Resonance).   "
37582|NCT02793713|"     Surgical removal of a tumour in the lung offers the best chance for survival in early stage     lung cancers. One main criteria of surgical eligibility is the absence of cancer spread to     the lymph nodes; rendering the staging process extremely important. The evaluation of these     lymph nodes is thought to be best completed using Endobronchial Ultrasound (EBUS), a     procedure in which several lymph nodes are sampled and send to pathology to determine whether     or not it is malignant. More recently, studies have observed that there are clear differences     in the characteristics of cancerous and benign (non-cancerous) lymph nodes, and so there has     been great interest in creating a list of criteria that can determine whether a node is     malignant. This study aims to prospectively validate a previously proposed score based on     observed characteristics of lymph nodes during an EBUS procedure relating to     pathology-confirmed results. To test this, the results of the lymph node samples and the     observed score will be compared for agreement. If the investigators find that the scoring     system can accurately predict which lymph nodes are cancerous, it would provide the evidence     to establish the score as a standard procedure during cancer staging.   "
37583|NCT02793700|"     Respiratory distress syndrome (RDS) is a life-threatening condition for premature neonates.     Antenatal glucocorticoids have been used clinically in women with threatened preterm birth to     accelerate lung maturation for more than 40 years. The current treatment strategy for women     with threatened preterm delivery is for a standard, one size fits all dosing with either     betamethasone (BMZ) or dexamethasone. It is well known that pregnancy introduces additional     variability in response to medication therapy with different physiological changes and     alterations in the activity of drug metabolizing enzymes. The objective of this project is to     evaluate the pharmacokinetic (PK), pharmacodynamic, and pharmacogenetic parameters of     betamethasone (BMZ) and determine the differences in response and benefit in pregnancy. An     individualized dosing approach to medications in pregnancy, such as BMZ, is crucial to     optimize efficacy of this important medication.   "
37584|NCT02793687|"     A multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group     study in patients with stroke   "
37633|NCT02793050|"     This is an independent, observational, retrospective post marketing study on the use of     trabectedin in a clinical setting.      A data collection on the clinical use of the drug will help to improve knowledge and might     contribute to optimize the clinical use of the drug.   "
37634|NCT02793037|"     Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept     for the successful retention and outcome measures of zirconia RBBs for the replacement of     missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival     rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).      The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to     have been reported in the literature (A search pf Pub Med and Google Scholar has not shown     any similar studies that have been published - pubmed.gov; Keywords: zirconia, resin,     clinical assessed on 17/10/2015 AND google scholar; Keywords: zirconia, resin bonded     fixed partial denture, resin bonded fixed dental prosthesis, Maryland, resin bonded     bridge posterior, clinical) In addition, currently there appear to be no clinical trials     planned or finished in this area (clinicaltrial.gov; Keywords: zirconia, resin assessed     on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there is a gap     in the literature on the use of zirconia for replacing posterior teeth with such prostheses.      The primary outcome measures would be: success ie. prosthesis retention ie. does not fall out      The secondary outcome measures would be:        -  complications of the prosthesis such as tipping, drifting or fracture.        -  patient centered outcomes (satisfaction and oral health related quality of life) on the          RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as          current data on 2-unit cantilevered metal-ceramic RBBs from this centre and that there          will be no difference in the patient centered outcomes.      The Primary review appointments will be at 1, 6, 12, 24 and 36 months. However, longer term     follow up will be performed and this centre has experience of such long term studies (9.5     years - Botelho 2014).      A randomized clinical trial (RCT) comparing to metal-ceramic RBBs will NOT be performed as     the 5-year success rate of both metal-ceramic (Botelho 2006) and anterior zirconia (Sasse     2014) prosthesis were higher than 95% and this small differences would mean an unattainable     large sample size in an equivalence test (Burns 2001).      Significance and implications Zirconia has significant strength and greater stiffness than     base metal alloys and displays clinical outcomes comparable to metal-ceramic conventional     crowns and bridges (Heintze 2010, Sailer 2007). Well polished zirconia has been observed to     have lower wear rates than porcelain (Stober 2014) Zirconia RBBs for posterior tooth     replacement will offer an esthetic and biocompatible treatment option to patients over the     traditional ceramic-metal RBBs. It is anticipated that patient demand for this would be high     as these prostheses should be as successful (retentive).      These results would re-write established dental prosthodontics textbooks and this would be     the first centre to report on the routine use of a 2-unit extracoronal all-zirconia RBB for     the replacement of missing posterior teeth.      Research plan and methodology The sample pool would be obtained from patients presenting at     the Prince Philip Dental Hospital, University of Hong Kong and who request and need     replacement of one or more missing teeth.. They will be clinically assessed for eligibility     and invited to participate with written consent in the study. After treatment they will be     reviewed up to a 3rd year endpoint of the study. Further review beyond this will be     undertaken.   "
37588|NCT02793635|"     The purpose of this study is to assess the use of Indego as a gait training tool for subjects     with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have     preserved lower extremity function. It is hypothesized that subjects with complete or     incomplete paraplegia who have preserved their lower extremity function will experience     functional improvements after gait training with the Indego exoskeleton.      Subjects will complete a total of fifteen (15) sessions which include a combination of the     following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and     Post-Assessment.      The aim of this study is to measure the impact of gait training with the Indego device on     body structure, function, and participation. Additionally it will assess the perceptions of     physical therapists and subjects with SCI on the effectiveness of gait training with the     Indego exoskeleton in subjects with preserved limited function.   "
37589|NCT02793622|"     This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected     pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation     will be randomized in equal proportions to one of two intermittent preventive treatment in     pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly     dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP     placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant     women will end approximately 6 weeks after giving birth. All children born to mothers     enrolled in the study will be followed from birth until they reach 12 months of age.   "
37590|NCT02793609|"     Randomized trial comparing double balloon catheter for induction of labor between in- and     outpatient groups.Investigators assess feasibility, clinical effectiveness and patient     acceptability of outpatient versus inpatient catheter for induction of labor.   "
37591|NCT02793596|"     In this study, we will set out to confirm the reliability of epidural waveform analysis (EWA)     as an adjunct to loss of resistance for obstetrical epidural blocks.   "
37592|NCT02793583|"     This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in     combination with another study drug called ublituximab with or without bendamustine and     TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or     that has not responded to standard treatment.   "
37593|NCT02793570|"     Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the     thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent     administration. This guidance is however, based only on consensus opinion supported by     limited case reports (level of evidence C).      Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP)     MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.   "
37594|NCT02793557|"     A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy     volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a     multiple dose (MD) part.   "
37595|NCT02793544|"     This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT)     using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors     and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF)     for graft versus host disease (GVHD) prophylaxis in patients with hematologic malignancies.   "
37596|NCT02793531|"     Weight loss and muscle wasting commonly occurs in patients with cancer, negatively     influencing their quality of life, treatment response and survival. Weight changes in     patients with cancer may be the consequence of energy imbalance and disturbances in protein     metabolism, poor treatment tolerance, hormonal alterations, systemic inflammation etc. This     results in body composition modifications in favor of fat gain and/or lean body mass loss in     early stage cancer. However, in advanced cancer mostly loss of both fat mass and lean mass     has been found.      Unfortunately, gains in muscle mass are difficult to achieve. In a previous study of the     Investigators, a bolus (15 g) of an essential amino acid mixture as present in milk protein     was able to stimulate whole-body protein anabolism equally and effectively in weight-losing     patients with lung cancer. This indicates the high potential of proteins with high essential     amino acids as therapeutic agents to increase muscle mass in these patients. However, the     dose-response effect to reach optimal whole-body protein anabolism is yet unknown and can     differ among patients. Therefore, the Investigators would like to study the effects of     several dosages of a protein with high essential amino acid levels, administered by sip     feeding, on whole-body protein anabolism in patients with cancer in comparison with healthy     older adults. Furthermore, the individual protein requirements of cancer patients may be     established as this is the cornerstone of nutritional support. Specifically to establish 'the     anabolic threshold', when protein breakdown equals synthesis and the response and the     relation between protein intake and net protein synthesis are critical.   "
37597|NCT02793518|"     Self-defining memories (SDMs) are memories that are still important today to understand who     the investigators are and participate to the maintain of personal identity. SDMs are also     linked to our capacity to project ourselves into the future. In bipolar disorder, life events     play an important role in the course and outcome of the disease. the study is the first to     investigate SDMs and self-defining future projections in a population of remitted patients     with bipolar disorder.   "
37598|NCT02793505|"     This study aims to better characterize the risk linked to metformin use during pregnancy,     using a prospective multicentric cohort design enabling a large sample size, in evaluating     the rate of birth defects after first trimester exposure, as well as several other pregnancy     related outcomes.   "
37599|NCT02793492|"     This is a multi-center, single arm, non-randomized, prospective clinical study using the     Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or     occlusive lesion(s) of the common and/or external iliac artery.   "
37600|NCT02793479|"     The aim of this study is to establish a nationwide registry to collect data regarding the     treatment of Barrett's Esophagus (BE) with radiofrequency ablation. The objective of this     registry is to increase the number of data and therefore obtain a raise of quality assurance     and improve outcome and patient security. Furthermore to provide participating physicians     information and experience for treatment details in the therapy of BE.   "
49220|NCT02640417|"     This is a double-blind, randomized study in parallel groups of subjects presenting with low     back pain. Randomized subjects will receive treatment for 60 days with either a combination     of nucleotides and vitamin B12 or vitamin B1+B6+B12.   "
37602|NCT02793453|"     Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide.     Etiopathological process involved in initiation and progression of these multifactorial     diseases are not well understood, explaining the huge clinical forms variability and the     complexity of the currently used classification of periodontal diseases. Recently, the     implication of antimicrobial peptides (AMPs) have been suggested as potential track of     explanation for periodontal diseases pathogeny. The here presented study explore the level of     expression of genes coding those peptides by studying periodontal smears obtained from     healthy and periodontitis patients.   "
37603|NCT02793440|"     The purpose of this study is to compare the clinical outcome of medical treatment associated     with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.   "
37604|NCT02793427|"     The objective of the study is to quantify the products of non-enzymatic glycation of proteins     (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients     without clinical complications in order to define the contribution of this markers in the     long-term monitoring of glycemic control in these patients. The results will define the     criteria for using these new markers in daily clinical practice for the monitoring of these     patients   "
37605|NCT02793414|"     This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath     indicative of an acute malaria infection. The investigators plan to enroll 75 malaria     patients and 175 febrile non-malaria patients in Ethiopia.      Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a     breath sample to assess the presence of biomarkers at a reference center. Malaria patients     identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD     testing will be performed concurrently to identify prevalent G6PD variants.   "
37606|NCT02793401|"     The investigators aimed to evaluate the short-term efficacy of High Intensity LASER Therapy     (HILT) and Ultrasound (US) treatment in chronic shoulder pain. It's a prospective,     randomized, controlled, single blind study.141 patients were randomized into two groups, as     HILT (n=71) and US (n=70) groups. HILT or US treatment was applied to the patients in     addition to 14 sessions of Hotpack (Hp) + Balneotherapy + Exercise treatment. Pre-treatment     (Pre-T), Post-treatment 1st day (Post-T1st day) and Post-T findings for the 30th day (Post-T     30th day) were recorded using the visual analog scale (VAS) and shoulder pain and disability     index (SPADI) scoring.   "
37607|NCT02793388|"     This is a randomized, controlled, open label trial to assess the effectiveness of     unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria.     In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is     high. Hence patients infected with either P. vivax or P. falciparum will be included in the     study. The study will be conducted in Ethiopia. Participants will be enrolled at health     centres and provided with the recommended schizontocidal treatment plus primaquine radical     cure which will be either supervised or unsupervised according to randomisation. Participants     will be followed up for four months and assessed at regular intervals for the presence of     patent and sub-patent malaria. The outcome of the study will contribute to an improved     treatment scheme for uncomplicated malaria in this area.   "
37608|NCT02793375|"     Objective: The purpose of the present study is to evaluate the effectiveness of preoperative     Montelukast as an analgesic for adenotonsillectomy      Study Design: Randomized controlled double blinded clinical trial.      Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric     Otolaryngology, Head and Neck Surgery      Methods: Children between the age of 3-8 undergoing adenotonsillectomy with planned 23 hour     observation for adenotonsillar hypertrophy and sleep disordered breathing will be randomized     to receive either montelukast or placebo in Same Day surgery.      Analysis: Differences in demographics (age, gender, race, weight) between the intervention     and control groups will be assessed using chi-square (for categorical measures) and t tests     (for continuous measures). Differences in postoperative opioid usage, postoperative pain     scores using the FLACC scale, and the number of postoperative contacts (Emergency department     visits or phone calls) with patients or their family regarding pain or tonsillar hemorrhage     will be evaluated using chi-square (categorical measures) and t tests (continuous measures).   "
37609|NCT02793362|"     The purposes of this study are        1. To explore effect of sarcopenia on recovery of post stroke hemiplegia        2. To explore the effect of stroke on sarcopenia and relationship between the degree of          sarcopenia and respiration and swallowing function        3. To quantify and qualify post stroke loss of muscle mass        4. To validity the use of echointensity and elastography in evaluation of sarcopenia.      By reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke     complications that is closely related to worth functional outcome, thereby emphasizing the     importance of evaluation of sarcopenia as well as its prevention.   "
37610|NCT02793349|"     ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a     bioresorbable drug eluting stent in the arterial vasculature below the knee   "
37620|NCT02793219|"     This clinical study will evaluate the role of combination therapy of Provenge followed by     docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate     cancer that is resistant to medical or surgical treatments that lower testosterone). The     purpose of this study is to look at the combination therapy of Provenge followed by docetaxel     to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are     genes, proteins and other molecules that affect how cancer cells grow, multiply, die and     respond to other compounds in the body. The study drugs are approved by the Food and Drug     Administration (FDA).      Treatment will be administered on an outpatient basis. Patients will receive Provenge     followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's     own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists     of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic     (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be     given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days).      The strategy aims to determine whether cytokine production and T cell infiltration of tumor     cells could favor regression using a combination of vaccine plus chemotherapy. Tissue     endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of     therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8,     CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be     secondary antigen spread and various cytokine biomarkers.   "
37611|NCT02793336|"     Malaria remains an important cause of illness in young infants. Our clinical and     epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in     infants in the first 5 years of life, including recurrent episodes of malaria, anaemia,     malnutrition and coinfection. Together these contribute significantly morbidity in early     life, and almost certainly to the very high infant mortality rates in this region. However     the body of knowledge around infant malaria outside of Africa, where both species P. vivax     and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax     malaria and severe anaemia on neurodevelopment and growth in young children is unknown in     Papua.      This study therefore aims to provide longitudinal data on the incidence of symptomatic and     asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It also     provides an opportunity to assess incidence risk of non-malaria febrile illnesses and     bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth in     a vulnerable age group. The study is a continuation from two already established cohort     studies: STOP MIP, which enrolled pregnant women and followed them until delivery and a     baby-cohort, which enrolled babies from mothers included in the cohort and followed them     through their first year of life. Continuous follow up of those babies until they are 4 years     old will increase our understanding of long term impact especially of vivax malaria. The     cohort will be linked to a randomized controlled trial (RCT) and will offer cohort patients     to be enrolled into the RCT when they are diagnosed with malaria (symptomatic), allowing to     estimate treatment effectiveness.   "
37612|NCT02793323|"     Shoulder pain is frequently mentioned in recent literature following laparoscopic operations.     Several pain relief strategies have been proposed to decrease shoulder tip pain post     laparoscopic surgeries. This study will be conducted to compare the Superficial cervical     nerve block vs. NSAIDs in terms of shoulder tip pain relief after laparoscopic surgeries.   "
37614|NCT02793297|"     The overall objective is to evaluate the impact of sourdough fermented crisp bread on effects     on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite     and postprandial insulin responses have been observed, particularly for unfermented rye crisp     breads in a previous study. In the present study, the investigators evaluated how the intake     of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well as a control     refined wheat crisp bread product may affect self-rated appetite and postprandial insulin and     glucose responses in healthy men and women in a meal-study. The investigators characterized     intervention products with regards to microstructural and chemical features in order to     elucidate underlying mechanisms for potential effects observed on appetite and postprandial     metabolic responses.   "
37615|NCT02793284|"     The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL     PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer     recurrence. This imaging uses a Positron Emission Tomography/Computed Tomography (PET/CT)     scan using a radioactive tracer 18F-DCFPyL that is concentrated in prostate cancer cells and     can potentially identify cancer cells throughout the body. The combination of 18F-DCFPyL     PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual     imaging [bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus     multi-parametric magnetic resonance imaging (MRI)].   "
37616|NCT02793271|"     A growing number of trials have demonstrated treatment effectiveness for people with mental     illness (PWMI) by non-specialist providers, such as primary care and community health     workers, in low-resource settings. A barrier to scaling up these evidence-based practices is     the limited uptake from trainings into service provision and lack of fidelity to     evidence-based practices among non-specialists. This arises, in part, from stigma among     non-specialists against PWMI. Therefore, interventions are needed to address attitudes among     non-specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE     Mental Health services (RESHAPE-mh), is an intervention for non-specialists in which social     contact with PWMI is added to training and supervision programs. A pilot cluster randomized     control trial will address primary objectives including trainees' perspectives on perceived     acceptability of PWMI's participation in training and supervision, intervention fidelity and     contagion, assessment of randomization, and feasibility and psychometric properties of     outcome measures in a cluster design. Secondary objectives are change in provider and patient     outcomes. The control condition is existing mental health training and supervision for     non-specialists delivered through the Programme for Improving Mental Healthcare (PRIME),     which includes the mental health Global Action Programme (mhGAP) and psychosocial treatments.     The intervention condition will incorporate social contact with PWMI into existing PRIME     training and supervision. Participants in the pilot will be the direct beneficiaries of     training and supervision (i.e., primary care workers) and indirect beneficiaries (i.e., their     patients). Primary care workers' outcomes include knowledge (mhGAP knowledge scale), explicit     attitudes (mhGAP attitudes and social distance scales), implicit attitudes (Implicit     Association Test), and clinical competence (Enhancing Assessment of Common Therapeutic     factors, ENACT) to be assessed pre-training, post-training, and at 4-month follow-up. Patient     outcomes include functioning, stigma experiences in accessing care, and depression/alcohol     use symptoms to be assessed at initiation of mental health care and 6 months later. The pilot     study will assist in modifying the intervention to inform a larger effectiveness trial of     RESHAPE to ultimately improve provider attitudes and clinical competence as a mechanism to     improve patient outcomes.   "
37617|NCT02793258|"     Background: transcranial direct current stimulation (tDCS) is an innovative treatment for     major depression. However, its mechanisms of action are still unclear. Major depression is     characterized by impaired processing of emotional information, which returns back to normal     after successful antidepressant treatment. In this randomized double-blind study, the     investigators aim to assess the effect of tDCS on emotional processing in major depression.   "
37618|NCT02793245|"     The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge     of the tracheobronchial anatomy in order to establish the best choice for the patient. The     literature is limited regarding major bronchi dimensions. In addition, the measurement method     is not always adequate or properly described and some publications have evaluated only the     left bronchial diameter. Computed tomography with 3D reconstruction, technical reference, has     been little used.      The project is to conduct a prospective study to compare patient characteristics (age,     height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if     available), and dimensions of the trachea and of the main bronchi from CT scans with 3D     reconstruction.   "
37619|NCT02793232|"     This study will test the safety, tolerability and blood concentrations of single and multiple     oral doses of PF-06751979 in health subjects and healthy elderly subjects. PF-06751979 is     being developed for the treatment of Alzheimer's disease.   "
37631|NCT02793076|"     The purpose of this mixed methods study is to evaluate the effects an 8-week group dance     intervention can have on body image and posture in breast cancer survivors.   "
38411|NCT02782858|"     The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human     endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical     role in multiple sclerosis (MS).      This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of     GNbAC1 in patients with relapsing remitting multiple sclerosis.   "
37621|NCT02793206|"     Optic nerve head Drusen are a mostly bilateral change of the optic nerve, eventually causing     a slow, but progression loss of the visual fields. Characteristic are the crystalline     deposits at the entrance of the optic nerve, the so called optic disc. The material consists     of calcium, calcium phosphate, iron, but also amino acids and polysaccharides.      The diagnose is made or confirmed by different imaging modalities like ultrasound and     auto-fluorescence imaging. By using the high-resolution imaging with spectral-domain optical     coherence imaging (SD-OCT) the volume and deposits at the optic disc can be measured and     quantified.      The purpose of this study whether and how defects in the visual fields are related to the     deposits. Multimodal imaging of the optic nerve head is planned within the cross-sectional     study, at two different time intervals (2 years). Changes in retinal fibre layer (RNFL)     thickness and disc parameters are analyzed. Presence and extent of auto-fluorescent changes     are evaluated. The prospective trial wants to clarify whether certain parameters at baseline     indicate the further outcome and development.   "
37622|NCT02793193|"     The gut-brain axis is described as being important in both, gut functions and central nervous     system (CNS) functions. The microbiota in the gut plays an important role in this axis     through neural, immune and endocrine systems. Previous studies have found altered gut     microbiota (GM) composition could change the CNS functions in animals and humans. Probiotics     were shown having positive effect on improving stress response in animals and stress related     psychiatry in humans. The current study will investigate if probiotics can improve response     to social stress in healthy participants and patients with irritable bowel syndrome (IBS),     which is a stress-related disease, and whether this probiotic action can be counteracted by     the locally acting antibiotic, Rifaximin. The investigators will use the Cyberball paradigram     to induce social stress and magnetoencephalography (MEG) to record neural responses related     to the social stress. The administration of the probiotics will be a new strategy for both     the mental health management and treatment of gastrointestinal (GI) disorders in the future.   "
37623|NCT02793180|"     In the Middle East and the Gulf, the general population have high cardiovascular risks like     diabetes, hypertension, smoking and obesity. The average age of a patient with an acute     coronary syndrome (ACS) event is relatively young compared to Western populations. Women are     multiparous and the rates of consanguinity marriages are high in this region of the world.     These risk factors and conditions result in heart failure. Great deal of knowledge is missing     regarding the influence of these risk factors on heart failure presentation, the causes and     management of heart failure in ambulatory patients in this region of the world.   "
37624|NCT02793167|"     Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant     mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of     AKI by early detection and timely referral to the renal,the investigators developed an     electronic alert system which identifies all cases of AKI occurring in patients over 18     years.The system was also designed to collect data on AKI incidence one of the biggest     tertiary hospital in China.   "
37625|NCT02793154|"     The primary objective of this study is to compare the effect of albiglutide and exenatide on     gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual     analogue scale [VAS]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided     in two parts. Part A will characterize the GMA, GE and nausea response to exenatide and     confirm exenatide as a positive control for Part B. Part B will compare the effects of     albiglutide and exenatide on GMA, GE and nausea.      Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg)     subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a     3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose     of exenatide). The total duration of a subject's participation in Part A will be     approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to     progress to Part B will be made.      In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of 30     milligrams [mg] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or     exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for     4 weeks). The total duration of a subject's participation in the study will be approximately     15 weeks.   "
37626|NCT02793141|"     The International study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE) is a     prospective, international, multicentre, observational, cohort study. The study aims to     provide up-to-date and generalisable information on current worldwide epidemiology and     clinical practice associated with diagnosis and management of nosocomial pneumonia in     Intensive Care Unit (ICU) patients.      PneumoINSPIRE study is endorsed by the European Society of Intensive Care Medicine (ESICM).   "
37627|NCT02793128|"     The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial     carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective     this will lead to the development of a new treatment approach for patients suffering from Low     Grade Upper Urinary Urothelial Carcinoma (UTUC).   "
37628|NCT02793115|"     This study seeks to ascertain the best way to inform patients about their physicians'     conflicts of interest (COI) with industry. Currently, there is no institutional or national     standard for such physician-to-patient disclosures. The primary aim of this study is to test     different written disclosures and assess their impact on patients' knowledge of their     physicians' COIs and on patients' trust in their physician and their healthcare institution.     The secondary aim is to investigate whether physician disclosures of significant financial     industry relationships are desired by patients and whether disclosures impact patients'     knowledge, perceptions, and behaviors. The tertiary aim is to investigate physicians' current     practices of disclosure and perceptions about the risks, benefits, and feasibility of using     patient disclosures to manage financial relationships, and to determine whether any physician     fears are borne out in practice once disclosures are implemented.   "
37629|NCT02793102|"     In the literature the use of olfactory dimension in the treatment of anorexia has not been     verified experimentally. The investigator hypothesize that the therapeutic use of a dietary     nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a     prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the     primary endpoint of the state of anorexia nervosa patients.   "
37630|NCT02793089|"     This study evaluates the increased risk of ectopic pregnancy associated with marked variation     of estradiol during the early luteal phase and high progesterone on hCG day in IVF.   "
37635|NCT02793024|"     The objective of this project is to develop and test the effectiveness of a Cooperative     Extension enhanced intervention titled Smart Shopping, aimed at improving the shopping     practices of adolescents with the ultimate goal of increasing fruit and vegetable intake. To     achieve this goal, the investigators will conduct formative research (Year 1) via a     community-wide analysis of the school, home and neighborhood food environments. In     collaboration with Extension staff and faculty, this formative research will provide insight     into the development and enhancement of the Smart Shopping curriculum (adapted from the     Cooking Matters Extension curriculum, Year 2). In Years 3-4, the investigators will     implement a randomized controlled intervention trial to examine the effectiveness of the     developed intervention Smart Shopping to improve adolescents' purchasing and consumption     behaviors. The investigators will implement the trial in Year 3, and evaluate results in Year     4. Our education component will include training of University dietetics interns, graduate,     and undergraduate students to implement and evaluate the intervention with oversight by     project staff as part of their service learning requirements. This project is unique as it:     1) takes into account the role that school wellness policies and school environment have in     food procurement during the day; 2) incorporates information from multiple levels of the     social ecological framework (home, school, and community food environments, as well as the     social influence of peers) to create an intervention that addresses influences on adolescents     purchasing and consumption behaviors where they live and learn; 3) collaborates with     Extension faculty and staff while enhancing an existing program; 4) utilizes and hones the     skill sets of students in undergraduate and graduate level nutrition and dietetics programs.   "
37636|NCT02793011|"     The investigators will use a prospective randomized, controlled design utilizing a single     preoperative dose of oral dexamethasone or placebo to achieve these specific aims:        -  Specific Aim 1: To evaluate the potential for a single preoperative dose of oral          dexamethasone administered the night before surgery to reduce the incidence and severity          of early post tonsillectomy pain (PTP) in children        -  Specific Aim 2: To prospectively evaluate differences in early PTP experience between          overweight/obese children and their lean peers.        -  Specific Aim 3: To determine whether circulating inflammatory markers are strongly          linked to PTP severity in children and whether they could be potential contributors to          the higher pain experienced by overweight/obese children following Tonsillectomy and or          Adenoidectomy.   "
37637|NCT02792998|"     The objectives of this study are:      Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic     (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects     over 7 days of repeated dosing      Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets     administered orally to healthy subjects, in fed and fasted states, in an open-label,     single-dose, 2-period, 2-sequence crossover study.   "
37638|NCT02792985|"     The objective of this Phase II trial is to evaluate the feasibility of this study protocol to     progress to a large-scale Phase III RCT in the future. It will also determine, with limited     efficacy, the effectiveness of the multisensory stimulation intervention protocol to reduce     the duration of post-traumatic amnesia (PTA), improve cognition, increase independence in     activities of daily living and long term quality of life of the affected person.      Participants will be randomised into either the experimental or control group. The     experimental group will follow the multisensory stimulation intervention protocol, while the     control group will follow the current hospital protocol.   "
37639|NCT02792972|"     Context: Research on natural products with therapeutic, analgesic or antimicrobial purpose     should be encouraged to create new drugs. Acmella oleracea, typical plant of the Northern     region of the country and popularly known as jambu, has aroused the interest of researchers     because of its therapeutic potential. Objective: To evaluate the potential topical analgesic     and antimicrobial of Acmella oleracea plant extract from the skin antisepsis in venipuncture     procedures. Methods: This is a clinical, randomized, controlled trial with healthy volunteers     recruited at the Clinic I of the collection of biological materials sector of the Hospital     das Clinicas Samuel Libânio, in Pouso Alegre-MG. The plant extract A. oleracea manipulated     with Transcutol® and 70% alcohol were used in the volunteers before the venipuncture     procedure as allocation in study groups. Held collection of skin microbiota by the swab     technique and the end of the venipuncture procedure was applied to the volunteer, the visual     numeric scale (VNS) standard to determine the degree of pain.   "
37640|NCT02792959|"     This study evaluates the therapeutic response by modern FMRI and PET techniques with the     perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize     the respective performances and to define the early assessment criteria, at the first detox,     of the treatment efficacy, with and without antiangiogenic agent.   "
37641|NCT02792946|"     Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients     with acute bronchitis   "
37642|NCT02792933|"     Epidural space localization using loss of resistance technique with air (ALOR) is     controversial in obstetric analgesia due to a minor efficacy and risk of complications,     compared with loss of resistance technique with saline (SLOR). This randomized prospective     study will compare the efficacy and incidence of most common complications of both techniques     in obstetric analgesia.   "
37643|NCT02792920|"     To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in     patients with ST-elevation acute myocardial infarction, as well as identify the     characteristics and efficacy of CoCr-EES.      Also, OCT sub-analysis will be conducted   "
37644|NCT02792907|"     Compressive stockings ameliorate functional outcome and quality of life in patients after     elective orthopedic foot and ankle surgery. In this randomized controlled trial the     investigators want to analyze the effect of compressive stockings after foot and ankle     surgery. Additionally the investigators want to evaluate the compliance of the compressive     stockings Treatment. Therefore an electronic chip device is implanted into the compressive     stockings to monitor wearing time.   "
37662|NCT02792673|"     The study design is a prospective randomized uncontrolled clinical trial. It will include 150     cases.      The aim of this study is to compare the efficacy of three different media used for embryo     transfer regarding chemical and clinical pregnancy rate, implantation rate and ongoing     pregnancy and miscarriage rates in IVF and ICSI cycles.      The three different embryo transfer media are:        1. Hyaluronan-enriched medium Embryo Glue®        2. 30% Protein-supplemented Culture medium Global Total®        3. Autologous Follicular Fluid (a Novel technique) In order to establish the optimal media          for embryo transfer   "
37663|NCT02792660|"     This is clinical feasibility study on the device performance with paediatric patients. The     main objective is to validate the performance of investigational device in distinguishing and     identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar     puncture on paediatric patients.   "
37645|NCT02792894|"     Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability     or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of     concept study, the investigators integrated social, technological and business innovations to     develop and successfully pilot a sustainable service for such children in one rural     population of 30,000. Affected families were identified through a mobile phone-based     interactive voice response system, and organised into family networks. 'Champion' family     volunteers were trained in evidence-based interventions. A Tablet-based android application     was developed for training, monitoring and supervision of the champions, based on the World     Health Organization's guidelines. The champions delivered the intervention to other families     in the network. The project was sustainable and demonstrated significant improvements in the     lives of children and their families in the first 6 months of its operation. The     investigators are scaling-up this intervention to a population of 1 million. The     investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up     programme using cluster randomized control trial nested within the scale-up study.   "
37646|NCT02792881|"     The purpose of this study is to explore the safety, feasibility, long-term and oncological     outcomes of laparoscopic total gastrectomy for remnant gastric cancer.   "
37647|NCT02792868|"     Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83     patients), with normal, non-diabetic renal function. The investigators quantify the     phophocalcic intake and excretion, realizing a food examination and a urine collection of 24     particular. The investigators will measure plasma levels of FGF23 serum calcium,     phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The     investigators will conduct a quantitative assessment of coronary calcification by a     non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an     analysis of collinearity. An adjustment will be made for confounding variables in a     generalized linear regression model.   "
37648|NCT02792855|"     The simple head extension is recommended for optimization of glottic visualization during     awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date     has conﬁrmed its superiority over snifﬁng position . In a prospective, randomized study,     the authors compared the snifﬁng position with simple head extension in awake orotracheal     Intubation   "
37649|NCT02792842|"     The purpose of this study is to evaluate the efficacy and safety of ART-123 for the     prevention of cancer treatment related symptoms in patients with postoperative stage II / III     colon cancer.   "
37650|NCT02792829|"     The study will be conducted in adult healthy participants and will consist of two phases:     Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a     Screening Period and a Baseline Period. The Randomization Phase will consist of 2 Periods     (each 6 days long) separated by a 1-day long Baseline Period and End of Treatment (EOT)     Period. A total of 60 participants will be enrolled into one of three arms. Arms 1 and 3     consist of 2 sequences, and Arm 2 consists of 4 sequences (as this is an incomplete block     design with 2 factors [number of capsules and whether water or apple juice is used as     vehicle]). Each participant will be randomized into one of 8 sequences.   "
37651|NCT02792816|"     Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum     malaria patients in Myanmar and artemisinin molecular markers analysis   "
37652|NCT02792803|"     The purpose of the study is to provide evidence that the efficacy of Xalatan will be superior     to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients     with primary open angle glaucoma. The study will also aim to prove the tolerability of     Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.   "
37653|NCT02792790|"     The investigators will prospectively evaluate tissue samples obtained from patients     undergoing carpal tunnel release surgery for amyloid in the soft tissue that is removed.     Patients who have tissue that stains positive for amyloid will undergo cardiac testing to     look for evidence of cardiac involvement.   "
37654|NCT02792777|"     The goal of this study is to improve the methods with which researchers identify patient     centered outcomes for use in research. Specifically, the investigators will test the     application of concept mapping as compared to one-on-one interviews as a comprehensive and     efficient method of identifying patient-important outcomes for use in research.   "
37655|NCT02792764|"     This study is to collect current information on complications rates of subjects undergoing     chemotherapy administration through Ports and peripheral IVs.   "
37656|NCT02792751|"     Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving     cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or     general anesthesia. The investigators primary outcome was to evaluate the effects of the     depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation     during the ERCP procedure by analyzing the biochemical parameters. And their secondary     outcome was the effects of anesthesia depth on propofol consumption and postoperative     sedation status.   "
37657|NCT02792738|"     The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.   "
37658|NCT02792725|"     The treating physician/investigator contacts Lilly when, based on their medical opinion, a     patient meets the criteria for inclusion in the expanded access program.   "
37659|NCT02792712|"     Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs.     ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance     imaging (CE-MRI) in STEMI patients undergoing primary PCI.   "
37660|NCT02792699|"     This trial is designed to determine what effects the human body has on the investigational     medicine, ABP 798, and what effects the body has on the investigational medicine after you     have been given it, and if this is comparable to what is seen for the licensed medicine,     rituximab, in patients with moderate or severe RA.      This study will assess if the investigational medicine is safe and effective in treating     moderate or severe RA compared to the licensed medicine.   "
37661|NCT02792686|"     This study is an open label, parallel group, single ascending dose, exploratory study     performed in a single site (Centre Cap, Montpellier, France).   "
37664|NCT02792647|"     The purpose of this study is to investigate the safety and tolerability of IX-01 after     multiple doses, and to determine the PK of IX-01 and activity of CYP3A4.   "
37665|NCT02792634|"     Obesity and obesity related health problems are globally recognized as one of the major     threats to public health. Bariatric surgery is the most effective and durable therapy option     for obesity and the improvement of obesity related co-morbidities. Non alcoholic     steatohepatitis (NASH) is an important comorbidity of obesity and improves after surgical     intervention. In this study investigators try to enlighten the weight independent mechanism     for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure will     be observed for at least 24 month. A liver and adipose tissue samples are gained during the     operation. Liver function and morphology are observed before and after operation with LiMAx,     FibroScan and ultrasound. Systemic inflammation is measured in blood samples before and after     surgical intervention. In order to check the microbiome stool samples are collected     throughout the entire observation period.   "
37666|NCT02792621|"     As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced     mobility and quality of life. To understand and reverse this negative process investigators     need to find new ways of improving the ability of muscle to perform physical activity. There     is some evidence that supplements may improve how the mitochondria work, and investigators     want to explore this idea in more detail, by measuring how the muscles work and respond to     exercise before and after taking the supplement. This will give us the basic information     investigators would need to see if this is a useful idea.   "
37667|NCT02792608|"     Brain Tumour (BT) survivors struggle with disabling physical, emotional, cognitive and     psychosocial sequelae. Unfortunately, to-date there has been very limited research into     rehabilitative interventions for this population. With 55,000 BT survivors in Canada alone1,     access to effective, evidence-based rehabilitative treatment that would improve BT survivors'     quality of life (QOL) and capacity to cope is a necessity. Mindfulness-Based Therapy's (MBTs)     are emerging as a potential treatment to address this need. MBTs are group-based     psychological treatments for coping with illness or disability, with the goal of improving     psychological wellbeing. Recent studies have begun to suggest a role for MBTs in addressing     symptom burden and QOL in the acquired brain injury (ABI) population, a heterogeneous     population that includes survivors of stroke and traumatic brain injury, as well as BT     survivors. High quality research including within-subject controlled trials, are needed to     demonstrate whether MBTs can provide efficacious, accessible and cost-effective treatment to     improve the lives of BT survivors.   "
37668|NCT02792595|"     The study aims to determine the Sun Protection Factor (SPF) of 8 cosmetic products in vivo on     the back of human participants, according to the International Standard Sun Protection Test     method by using a sun simulator.   "
37669|NCT02792582|"     Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in a     region of the brain near the pituitary gland, visual pathways, and central blood vessels.     Patients often present with headache, loss of vision or delayed growth. In some instances     they may present with imbalance of water and salts in the body.      The treatment for craniopharyngioma may be radical surgery or a combination of surgery and     radiation therapy. In some instances surgery is not required. If the tumor cannot be     completely removed, radiation therapy may be required. In this study we will use the most     advanced form of proton therapy which is called intensity-modulated proton therapy. This is a     newer form of radiation therapy which has a number of advantages over older forms of proton     therapy and conventional radiation therapy using x-rays.      The main goal of this study is to learn if proton therapy will effectively treat patients     with craniopharyngioma brain tumors and reduce side effects compared to more traditional     forms of radiation therapy.   "
37670|NCT02792569|"     The aim of this project is to activate recruitment and growth of resting primordial follicles     in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to     become pregnant, either naturally or after assisted reproduction.   "
37671|NCT02792556|"     According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et     des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing     number.      The success rate of drug abortion before 49 days of amenorrhea, defined by the National     Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending     on the pregnancy term and the dose used.      The control visit is performed between the 14th day and the 21th day post abortion. Its role     is to monitor the effectiveness of the method, to verify absence of complication and to     better adapt contraception to prevent another unwanted pregnancy. The choice of the method is     left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.      In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed     during the control visit is transvaginal ultrasound.      To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive     alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and     low cost.      The main objective of this study is to evaluate the diagnostic value of urine pregnancy test     CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion     during the control visit.      This is a monocentric observational study.   "
37672|NCT02792543|"     In the case of intestinal failure with a high-output double enterostomy, the parenteral     nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive     continuity. PN has its own morbidity, and in the absence of expertise, the risks of     infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is     an enteral nutritional technique which reestablishes the functional continuity of the     anatomically present small bowel through an extracorporeal circulation of the chyme. In     patients with intestinal failure with a temporary high-output double enterostomy, we     hypothesize that CR, compared to PN will reduce post-operative complications after surgical     reestablishment of digestive continuity, maintain the intestinal function including     absorption, and reduce the complications during the transitional period pending the surgical     reestablishment of digestive continuity.   "
37673|NCT02792530|"     This study will evaluate the efficiency of dietary intervention on intradialytic weight gain.     Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5     kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for     sodium restriction. One month after the intervention, their intradialytic weight accumulation     will be measured.   "
37674|NCT02792517|"     A pharmacokinetic drug interaction study of AMG 334 and an oral contraceptive containing     progestin and estrogen.   "
37679|NCT02792452|"     The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging     and tests that would give more definitive answers are needed. The value of increase in Aortic     Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and calculation of     valve compliance/resistance during stress echo (SE) in the symptomatic moderate AS population     prognostication has to the investigators knowledge not been examined before. Similarly the     additive value of myocardial blood flow reserve (MBFR), Computed Tomography (CT) calcium     score, speckle tracking echocardiography, carotid ultrasonography, and N-Terminal pro B- type     natriuretic peptide B (NT-proBNP) in the prognostication of this population group especially     in combination with SE remains unclear.   "
37680|NCT02792439|"     America Walks is an observational research study to determine walking behavior of individuals     in the United States. The entire study will be conducted virtually by requiring participants     to download a mobile phone application (App), The App will leverage the mobile phone's step     count sensor technology to automatically determine participants' daily walking activity.     Participation is voluntary. Participants can choose not to participate or choose to     participate and then stop participating. Participants decision will not result in any penalty     or loss of benefits to which they are entitled.   "
37681|NCT02792426|"     To better understand the PK and associated pharmacodynamic (PD) responses produced by the     Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to        -  The subject's own brand combustion (non-menthol) cigarette and a U.S. FDA approved          smoking cessation product, the NICOTROL Inhaler, in current non-menthol cigarette          smokers who have some limited e-cigarette experience (Group 1).        -  Commercially available products in current primarily e-cigarette users (experienced ENDS          users) (Group 2) The PK/PD session for each product will be conducted in a controlled          clinical setting with frequent PK sampling after 14 hours of supervised abstinence from          all forms of nicotine. Subjects will familiarize themselves with the Research ENDS          S-TA-U001 and NICOTROL Inhaler by using each product in the real world for one day          before the PK/PD session for that product.      Primary Objectives:      Group 1 objectives are to characterize the nicotine PK profile (eg, maximum plasma     concentration [Cmax], time to maximum plasma concentration [Tmax], area under the     concentration-time curve [AUC], and terminal half-life [t1/2]) for 10 inhalation and ad lib     sessions of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level     during the 4.5-minute 10 inhalation and the 6 hour ad lib use sessions, to compare the PK     profiles between Research ENDS S-TA-U001 to the profiles of combustion cigarettes measured at     the baseline session, and to demonstrate superiority of PK profile of Research ENDS S-TA-U001     to that of the marketed NICOTROL Inhaler.      Group 2 objectives are to characterize the nicotine PK profile of Research ENDS S-TA-U001 and     explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and 6     hour ad lib use sessions, and to compare the PK profile between Research ENDS S-TA-U001 to     the profile of a commercial ENDS product measured at the baseline session.      Secondary objectives:      Secondary objectives include comparison of the nicotine PK of the Research ENDS S-TA-U001 to     the subjects' normal nicotine source (combustion cigarettes for Group 1 or commercial ENDS     for Group 2), to evaluate the safety and tolerability of Research ENDS S-TA-U001, to evaluate     the effects on craving and user satisfaction of the Research ENDS S-TA-U001 vs a combustion     cigarette or the NICOTROL Inhaler (Group 1) or a commercial ENDS product (Group 2), and to     evaluate various biomarkers following use of each test product.   "
37682|NCT02792413|"     Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease     females the effect of denosumab:        -  on bone mineral density (femoral T-score) at 24 months        -  on bone mineral density evolution (femoral T-score) after 24 months of follow-up        -  on bone mineral density evolution (lumbar T-score) after 24 months of follow-up        -  on coronary and abdominal aorta calcification scores evolution after 24 months of          follow-up        -  on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and          calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone          alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of          follow-up        -  on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of          follow-up        -  the tolerance after 24 months of follow-up   "
37683|NCT02792400|"     In normal physiology, glucagon from pancreatic alpha cells plays an important role in     maintaining glucose homeostasis via its regulatory effect on hepatic glucose production.     Patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state,     and in response to ingestion of glucose or a mixed meal.glucagon, glucagon concentrations     fail to decrease appropriately and may even increase. This diabetic hyperglucagonaemia may     therefore contribute importantly to the hyperglycaemia of the patients.      Several glucose-lowering treatment modalities have been shown to affect glucagon levels in     patients with type 2 diabetes, but the role of glucagon in the glucose-lowering effects of     these treatment modalities has been difficult to discern. By using a glucagon receptor     antagonist (GRA) the investigators will exploit glucagon receptor antagonism to delineate the     role of glucagon during treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors and     dipeptidyl peptidase 4 (DPP-4) inhibitors, which have been shown to increase and decrease     plasma glucagon levels, respectively.   "
37684|NCT02792387|"     The aim of the study is to explore association between increased central venous pressure,     Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1     and 2. The pilot study was set to provide the expected correlation coefficient for a sample     size determination of the subsequent study.   "
37685|NCT02792374|"     The objective of this descriptive investigation was to evaluate the psychological profile of     dental patients in three levels: global level, the dimensional level, and the discrete     symptom level and to compare it with a control group.   "
37686|NCT02792361|"     This is a clinical trial where patients who present to the neurosurgery service in need of a     procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled     for the randomization in the placement of a drain at the surgical site. At present, there is     not a protocol for whether or not to use a drain following this procedure. There is some     debate on whether it serves any real benefit for the patient or if it may actually be     detrimental in cases where infection occurs. This study aims to answer this question by     randomizing patients to drain placement and then comparing patient outcomes between the two     groups. These include the following: infection rate, length of hospital stay, self-reported     patient pain and discomfort, the amount of time before patients are able to open their eye     ipsilateral to the side of operation, change in forehead circumference post-op days 1-3, and     any unforeseen post-operative complications. This will be accomplished through using a     patient-administered survey, recording physical measurements, and a patient chart review.     Statistical analysis will then be used to identify any differences that may exist.   "
37713|NCT02791997|"     The project studies auditory processing after brain damage (in temporal and/or frontal areas)     and in migraine. The auditory processes investigated are attention, short-term memory,     sound-induced emotions. To characterize auditory deficits after brain damage or in migraine,     neuropsychological assessments are combined with neurophysiological markers     (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging:     MRI).   "
49270|NCT02641015|"     A retrospective observational study to assess the clinical management and outcomes of     hospitalised patients with complicated urinary tract infection in countries with high     prevalence of multidrug resistant gram-negative bacteria (COMBACTE-MAGNET,WP5)   "
37687|NCT02792348|"     For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are     difficult to confirm only with morphological examination (ultrasonography, intravenous     pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time     allows the post confirmation of a significant UFI requiring a surgery. This meant that the     actual therapeutic indications are imperfect by the absence of an absolute endpoint for     UFI.      The objective of the study is to characterize the urinary metabolomics profile of new born     with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction     anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal     ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This     characterization will allow the identification of statistically significant metabolomics     markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The     evolution with time of these metabolomics profiles will also considered.   "
37688|NCT02792335|"     To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF)     patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).   "
37689|NCT02792322|"     This study is designed to investigate if transoral surgery with the patient in the seated     position utilizing the da Vinci&#174; Robotic Surgical System (Intuitive Surgical, Inc.,     Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant     tumors of the throat.   "
37690|NCT02792309|"     Mathematica was awarded a contract by ACF to conduct the evaluation of selected grantees     offering Healthy Marriage and Relationship Education Programs.This particular evaluation will     focus on the University of Denver's MotherWise program, which offers relationship education     and other supports to low-income women expecting a baby. The program has three core     components: (1) 18 hours of core workshop sessions using the Within My Reach relationship     education curriculum supplemented with content on mother-infant relationships; (2) case     management services; and (3) optional relationship education workshops for couples. The     evaluation will test the effect of this full package of services on mothers' relationship     outcomes, as well as other outcomes related to child well-being, such as co-parenting and     father involvement.   "
37691|NCT02792296|"     This is an open-label study in adults to assess at-home Project: EVO Monitor measurements     over repeat play cycles. The study has three arms:playing multiple times per day, once daily,     and once weekly for 4 to 8 weeks.   "
37692|NCT02792283|"     The objective is to evaluate the function of the platelet in patients undergoing     hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood     assay with three pathways of platelet activation to describe a platelet response profile.      The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that     may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to     anticoagulate the hemodialyzer, on platelet function will be assessed.   "
37693|NCT02792270|"     This study is being conducted to decrease the rate of surgical wound complications. The     investigators are studying the effects that caloric restriction has on decreasing the rate of     surgical wound complications.   "
37694|NCT02792257|"     Alzheimer's disease (AD) is the most prevalent neurodegenerative disease of aging.     Neuropsychiatric symptoms (NPS) in AD are a major cause of burden to patients, caregivers,     and society and are near-universal at some point in the AD course. One of the most troubling     of these symptoms is agitation (Agit-AD), typified by a variety of problem behaviors     including combativeness, yelling, pacing, lack of cooperation with care, insomnia, and     restlessness There is a great need for better interventions that target Agit-AD, a major     source of patient disability as well as caregiver burden and stress, particularly in the case     of moderate to severe agitation. This pilot trial could open the door to re-purposing     Dronabinol (Marinol®) as a novel and safe treatment for Agit-AD with significant public     health impact.   "
37695|NCT02792244|"     Previous studies show that incontinence is relatively common during pregnancy and after     delivery. Experiencing incontinence during pregnancy or in the first year after delivery     increases the risk of long term incontinence. There is scarce documentation of the long term     prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and     risk factors for incontinence approximately six years after delivery among the 1718 who     participated in two previous studies exploring the prevalence and predictors of anal     incontinence in late pregnancy and during the first year after first delivery, and the effect     of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased     awareness and knowledge about risk factors and long term prevalence of anal incontinence     among health professionals as well as pregnant and parous women may give indications about     which women to target for preventative measures to reduce the risk of new onset of postpartum     AI during pregnancy and after delivery. Further, increased knowledge may aid in planning     individualized follow-up during pregnancy and the first year as well as in the long term     among women with existing AI symptoms.   "
37696|NCT02792231|"     To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4     weeks versus teriflunomide administered orally once daily in patients with relapsing multiple     sclerosis   "
37697|NCT02792218|"     To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4     weeks versus teriflunomide administered orally once daily in patients with relapsing multiple     sclerosis   "
37710|NCT02792036|"     Retinoblastoma (RB) is the most common intraocular tumor of childhood. Recurrent or     refractory disease following therapy most often occurs due to persistence of vitreous disease     and/or retinal reactivation of the main tumor mass. With this treatment protocol,     investigators seek to identify a less invasive method of local drug delivery that does not     disrupt the eye's integrity.      PRIMARY OBJECTIVE:        -  To determine the safety and toxicity profile associated with intravitreal carboplatin          for the treatment of recurrent or progressive intraocular retinoblastoma with vitreous          seeding.      SECONDARY OBJECTIVES:        -  To estimate the ocular salvage rate after treatment with intravitreal carboplatin in          patients with recurrent or progressive intraocular retinoblastoma with vitreous seeding.        -  To evaluate the effects of intravitreal carboplatin therapy on the histopathology of          eyes enucleated for progressive or recalcitrant disease while on therapy.   "
37711|NCT02792023|"     Prospective study to test whether the immunochemical fecal occult blood test (FIT) for     colorectal cancer (CRC) helps to prioritize patients with iron deficiency anemia for     colonoscopy.   "
37698|NCT02792205|"     Von Willebrand Disease (VWD) is defined as an inherited bleeding disorder that is caused by     deficiency or dysfunction of von Willebrand factor (VWF), a plasma protein that mediates the     initial adhesion of platelets at sites of vascular injury and also binds and stabilizes blood     clotting factor VIII (FVIII) in the circulation. The most severe forms of VWD are usually     easy to diagnose (obvious hemorrhagic symptoms and major VWF deficiency), whereas the mild     forms of the disease are still difficult to confirm. It is indeed reported that about 1% of     the population carry mild biological VWF deficiency without any bleeding tendency and any     actual disease. On the contrary, some patients with severe bleeding history can carry a     true VWF abnormality, well-confirmed by genetic studies, without any VWF deficiency when     evaluated with standard biological methods, such as Ristocetin Cofactor activity (VWF:RCo).     However, in these patients, the use of alternative methods, such as PFA-100 (Platelet     Fonction Analyzer-100), the study of Factor VIII (FVIII:C) to VWF (FVIII:C/VWF) ratio or the     evaluation of VWF activity using more specialized methods such as VWF:CB (VWF-Collagen     Binding) assay can detect the VWF deficiency and possible hemorrhagic predisposition.      In this project, the investigators plan to assess the performance of VWF:CB in the diagnosis     of VWF deficiency in patients with unexplained bleeding history.   "
37699|NCT02792192|"     This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics,     immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of     atezolizumab administered by intravenous (IV) infusion alone and in combination with     intravesical BCG in high-risk NMIBC participants. The study will be conducted in following     cohorts: Cohort 1A, Cohort 1B, Cohort 2, and Cohort 3. Atezolizumab will be administered at a     fixed dose of 1200 milligrams (mg) every 3 weeks (q3w) for a maximum of 96 weeks. BCG will be     administered to evaluate dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or     maximum administered dose (MAD). De-escalation will be allowed for up to three dose levels of     BCG (full dose [50 mg], 66 percent [%] of a full dose, and 33% of a full dose [Cohort 1B     only]). After the MTD or MAD is determined for Cohort 1B, this dose will be used for all     subsequent participants enrolled into Cohorts 1B, 2, and 3, unless the MTD is determined to     be 33% of a full BCG dose. If MTD is determined to be 33% of a full BCG dose, then, no     participants will be enrolled into Cohorts 2 and 3 until an assessment of the safety and     activity of the combination of atezolizumab plus 33% of a full BCG dose is completed.   "
37700|NCT02792179|"     This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who     previously participated in study BP29409 (NCT02187627). This study is designed to assess the     longitudinal change of Tau pathology in the brain of participants with AD using the PET     ligand [18F]RO6958948 and to assess the safety and tolerability of PET ligand.   "
37701|NCT02792166|"     The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades.     Surgery remains the cornerstone of treatment of obesity and related comorbidities such as     type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a)     those that cause restriction, and b) those that add a malabsorptive component to restriction.     Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most     frequently performed procedure in North America.      Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass     (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective     procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS     procedure has been shown to be significantly more effective than RYGB in achieving durable     weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes,     the performance of BPD-DS is highly institution dependant and comprises less than 5% of the     annual bariatric procedures performed worldwide.      Common reservations against BPD-DS are related to the side effects of the procedure, and     include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition.     Furthermore, longer operative times and surgical technical challenges are also reasons for     lower prevalence of the BPD-DS procedure.      Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of     the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is     a suitable second-stage or salvage procedure for severely obese patients with inadequate     weight loss or resolution of obesity-related comorbidities after SG. Despite showing     excellent results of up to 5 years with acceptable postoperative morbidity, all the     literature on SADI-S originates from a single center and has not been compared directly with     BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative     outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients.      This project has three specific aims:        1. To evaluate feasibility and short-term safety of SADI-S.        2. To evaluate short and long-term beneficial outcomes.        3. To evaluate and compare long-term morbidity.   "
37702|NCT02792153|"     The purpose of this study is to determine whether estrogen may help reduce fear of high     calorie-density foods in weight-restored women with Anorexia Nervosa (AN).   "
37703|NCT02792140|"     In this study, the investigators pose the question which influence the opioid circuit has on     positive valent situations in dreams.   "
37704|NCT02792127|"     The purpose of this study is to investigate the efficacy of an online program in reducing     symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative     evaluations and improving quality of life in students with above-average social anxiety.   "
37705|NCT02792114|"     The purpose of this study is to test the safety of different doses of specially prepared T     cells collected from the blood. The investigators want to find a safe dose of these modified     T cells for patients who have metastatic HER2-negative breast cancer.   "
37706|NCT02792088|"     To prove that a study drug is noninferior to a control drug with a proportion of subjects who     showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week     administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic     hepatitis B patients   "
37707|NCT02792075|"     The purpose of this study is to evaluate the prognosis of coronary stenosis based on     intracoronary Imaging.   "
37708|NCT02792062|"     The purpose of this study is to evaluate food effects on the pharmacokinetics of a single     oral dose of TAK-385 in Japanese premenopausal healthy adult women.   "
37709|NCT02792049|"     Investigators compared tidal volumes for single rescuer ventilation using a modified bag     valve mask with an integrated internal handle versus a conventional bag valve mask in a     manikin model.   "
37712|NCT02792010|"     Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage     modifications could provide better patient treatment. The T1rho MRI sequence allows the     quantification of the cartilage signal that is correlated to modifications of the cartilage     matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of     hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the     measurements. T1rho and T2 mapping sequences were acquired twice during the same session with     30 minutes interval to see if values were modified after a 30 minutes delay in a supine     position. The secondary objective was to assess the correlation between T1rho and T2 values.   "
37714|NCT02791984|"     Respiratory changes in aortic blood velocity have been described as an indicator of fluid     responsiveness when measured in the left ventricular outflow tract by trans esophageal     echography. A threshold value of 12% allowed discrimination between responders and     nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is     already used to measure cardiac output. The primary endpoint of this study is to determine     the predictive value of the respiratory variability in aortic blood velocity measured by     suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint     is to compare maximum velocity and velocity time integral measured by suprasternal and     transthoracic view.   "
37715|NCT02791971|"     The purpose of this study is to determine whether delivery of SpeakOut, a behavioral     intervention to increase social communication about long-acting reversible contraceptive     (LARC) methods among adolescents, is associated with increased uptake of LARC methods among     the social contacts of SpeakOut recipients.      The investigators will conduct a cluster randomized controlled trial of SpeakOut with     adolescent LARC users and their female peers. Over three years, SpeakOut will be implemented     in eight partner clinics. IUD and implant users aged 15 to 19 who attend appointments at     participating clinics will be invited to enroll in the evaluation study as primary     participants and receive either SpeakOut or a control intervention about alcohol use. The     social contacts of primary participants will be asked to enroll in the study as secondary     participants. The study's primary outcome will be the proportion of sexually-active secondary     participants who initiate use of a LARC method within 9 months of study enrollment.   "
37716|NCT02791958|"     This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR     (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective     reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.   "
37717|NCT02791945|"     The goal of the project is to improve the care of Veterans with mild traumatic brain injury     (mTBI) and unhealthy alcohol use.   "
37718|NCT02791932|"     Fifteen percent of women experience depression during pregnancy or postpartum (i.e.,     perinatal depression). Furthermore, 38% of low income women experience postpartum depression.     Given few women with perinatal depression seek treatment, there is a need for innovative, low     cost interventions that can be integrated within existing community-based programs serving     women in need (e.g., low income women). The primary aim of this study is to examine the     efficacy of a novel exercise intervention designed to prevent perinatal depression among     women attending federally qualified health centers serving high risk women.   "
37719|NCT02791919|"     This phase I trial studies the side effects and best dose of wee1 kinase inhibitor AZD1775     when given together with fludarabine, cytarabine, and filgrastim (FLAG) combination     chemotherapy in treating children, adolescents and young adults with relapsed or refractory     acute myeloid leukemia. Wee1 kinase inhibitor AZD1775 may help combination chemotherapy work     better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as     fludarabine and cytarabine, may prevent tumor cells from multiplying by damaging their     deoxyribonucleic acid (DNA), which in turn stops the tumor from growing. Giving wee1 kinase     inhibitor AZD1775 and FLAG chemotherapy may work better in treating patients with acute     myeloid leukemia.   "
37720|NCT02791906|"     Heart failure (HF) is an epidemic and is a major burden on the US healthcare system. The most     common cardiovascular endpoint is HF. Thus, novel interventions to prevent HF in CKD are     highly desirable. This study will assess: the variability in the response to ISMN therapy;     the degree of change in central hemodynamics and cardiac endpoints through analysis of     changes in LV mass, diffuse myocardial fibrosis, and myocardial systolic and diastolic     function.   "
37721|NCT02791893|"     The researchers propose studying Gulf veterans with Gulf War Illness (GWI), characterized by     a problem with widespread pain. Besides their pain, the researchers will also assess the     effect of vagus nerve stimulation (VNS) in alleviating migraine headache, another complaint     of Gulf veterans, which is common in the presence of widespread pain. Importantly, the     researchers are partnering with a company that has made a hand-held device that allows for     stimulation of the vagus nerve without the need for surgery; it works by the patient putting     it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second     periods three times a day. The device is programmed to deliver only 6 bouts of stimulation     per day - one to each side of the neck three times a day; it is then inactive until the next     day. The fact that this device can be used without surgery and is non-invasive makes it     extremely practical for use.      After collecting pre-treatment measurement of pain severity and headache severity, veterans     will receive either the actual active VNS device or an inactive device, which does not     stimulate the nerve. Veterans will use their device for ten weeks - providing similar     information periodically over this period by responding to questions about the severity of     their pain and headaches, They will then return to the Center for the final phase of the     study where all veterans will receive active devices. Ten weeks later, they will return to     the Center to provide information to allow the investigators to gain further knowledge as to     the effectiveness of actual VNS in relieving pain - both throughout the body and in the head.   "
37722|NCT02791880|"     In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly     utilized alternative procedure for replacing a stenotic aortic valve. This study collects     clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in     order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR     and to identify key clinical and procedural predictors of AKI. This study seeks to identify     blood and urine biomarkers that can be used for early detection of AKI around the time of the     procedure. The study seeks to assess for novel genetic variants associated with development     of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and     biomarkers that are associated with adverse cardiovascular events after TAVR and to further     explore how these events may inter-relate with acute kidney injury.   "
37723|NCT02791867|"     The primary objective is to determine if subjects taking the natural product AphoelineBrake™     in addition to their standard treatment experience differences in metabolic disease control,     gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to     patients taking a placebo in addition to their standard treatment. The secondary objective is     to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.   "
37724|NCT02791854|"     Innovative programs exist that suggest that care for people with chronic conditions is     optimized when patients and providers have the information they need at the point of care and     over time, to engage in shared planning and execution of treatment goals and care plans. This     project aims to build an Inflammatory Bowel Disease Learning Health System, a shared     information environment, that highlights collaboration among patients, clinicians and care     team members, and researchers; for effective use of data for guiding care, value,     improvement, and research.   "
37725|NCT02791841|"     The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training     (RRT), a computer-assisted intervention method that combines sublexical reading exercises     with rhythm processing, and that of an intervention resulting from the combination of two yet     validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific Stimulation (VHSS)     and the Action Video Game Training (AVG). Finally, the effectiveness of the administration of     only AVG is intended to be compared to other treatments. All interventions are administered     for 13 hours over 9 days to a group of Italian students with DD aged 8-12.   "
37726|NCT02791828|"     Chronic Hemodialysis is a treatment for kidney failure. It involves the construction of three     treatment sessions per week extrarenal lasting 4 hours each. This treatment is necessary but     it has an impact on the quality of life of patients.The investigators believe that to improve     the overall quality of life in hemodialysis patients, the quality of each hemodialysis     session must be improved. The quality criterion is not only medical, it must also take into     account the patient's perception about the course of its meeting : that's what we call     quality of experience of the dialysis session. Our daily healthcare practice shows that each     hemodialysis session is experienced differently by the patient according to different factors     : physical, psychological, relational, technical, temporal. The quality of the experience of     a hemodialysis session could be positively influenced by the use of supplements occupational     assets or liabilities, for improving patient satisfaction or by enhancing its relationship     with the staff. Indeed, a preliminary study ( in the nephrology unit of our establishment in     January 2012) of 8 patients undergoing active occupational educational activity during     hemodialysis, showed that the experience of the hemodialysis session was potentially     improvable (experienced patients improved, reduced cramps ... ). However, to assess the     impact of such measures on the lives of the dialysis session and the quality of life in     general, the investigators need to measure the quality of living of a dialysis session. There     is not, at present, specific tool to measure the quality of the experience of a hemodialysis     session. This tool would measure the impact of a caregiver support occupational during     dialysis sessions. The main objective of this study is to create and validate an instrument     to measure the quality of living of a hemodialysis of chronic renal insufficiency subject.   "
37727|NCT02791815|"     The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on     the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much     midazolam is present in the blood)   "
37728|NCT02791802|"     This multicenter multinational prospective two-arm matched-pair observational study aims to     establish a prospective comparison of active lipoprotein apheresis treatment approved and     conducted according to German guidelines for the indication of elevated Lp(a) versus a     maximum tolerated lipid-lowering therapy as standard care. Due to the prospective character     and the inclusion of a control arm, this will be the first clinical study that can confirm     the relevance of the established approach to use lipoprotein apheresis in those subjects and     its effects to reduce the individual cardiovascular risk. The optimized management of     subjects in the control group (not receiving lipoprotein apheresis) will also help to clarify     the controversial issue, to which extent intensive medical care per se can influence the     occurence of subsequent cardiovascular events. Primary objective of the trial is to evaluate     the clinical benefit of Lp(a) reduction using lipoprotein apheresis on myocardial infarction,     PCI, CABG and death from cardiovascular disease. The primary objective of this study     evaluates the clinical benefit of weekly lipoprotein apheresis in subjects with progressive     cardiovascular disease, as accepted by the German Federal Joint Committee as indication for     subjects with elevated Lp(a). Comparator will be matched subjects under maximum tolerated     lipid lowering therapy without access to lipoprotein apheresis treatment. The clinical     benefit will be defined as the reduction of the composite endpoint of major adverse     cardiovascular events (MACE), defined as either myocardial infarction, PCI, CABG or death     from cardiovascular disease over a period of at least 2 years after completion of visit 1b     and until at least 60 events of the primary end-point occurred in group B. If the number of     at least 60 documented primary endpoint events within 2 years of the completion of enrolment     did not occur, the study will continue until this number of primary endpoint events has     accumulated.   "
37729|NCT02791789|"     Use of the software could allow learning of reading code in subjects with ASD through the     design of serious games for educational and therapeutic purposes.      This SEMATIC software could improve communication and could be integrated into medical     management (speech therapy and neuropsychological).      The benefit of an action research will enable training professionals to autism, cognitive     characteristics of autism and the use of IT support for this population.   "
37730|NCT02791776|"     The problem of choosing the supporting vertebra was the subject of several studies. They do     not suggest as regards the techniques that are not currently used or with insufficient     setback.      The need to have a sufficient number of files with a minimum decline of 5 years for proposing     a multicenter study that will be conducted within the framework of the Scoliosis Research     Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES     gathers most of the teams that support this pathology.   "
37731|NCT02791763|"     This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to     compare the efficacy (verification of noninferiority) and safety of GSK1278863 administered     for 52 weeks versus epoetin beta pegol in approximately 270 Japanese non-dialysis (ND) and 50     peritoneal dialysis (PD) subjects with renal anemia.      The study will consist of 2 cohorts of different subject populations. This study consists of     a 4-week screening phase, a 52-week treatment phase (including the primary efficacy     evaluation period [Weeks 40 to 52]), and a 4-week follow-up phase following the treatment     phase.      The primary objective of this study is to demonstrate non-inferiority of GSK1278863 to     epoetin beta pegol based on hemoglobin (Hgb) in the ND subject population included in this     study. Study results will be used as pivotal study data for an NDA submitted for GSK1278863     for the treatment of renal anemia in Japan.   "
37732|NCT02791750|"     Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its     efficacy. The objective of this study is to know the women experience (persistence, treatment     changes, quality of life) and its determinants, in a french population.   "
37733|NCT02791737|"     This pilot trial studies a structured exercise program intervention in improving physical     activity in older patients with hematologic malignancies undergoing cancer therapy. Patients     with hematologic malignancies are at an increased risk of functional dependence and injury.     Structured exercise programs, such as the Otago exercise programme (OEP), may improve     balance, strength, and prevent fall-related injury in older patients with hematologic     malignancies undergoing cancer therapy.   "
37771|NCT02791243|"     This study evaluates the potential for induction of photosensitization by P-3074 0.25%     finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a     negative control (0.9% sodium chloride, NaCl)   "
37772|NCT02791230|"     Phase 3 extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg     tafamidis meglumine in subjects with either transthyretin genetic variants or wild-type     transthyretin resulting in amyloid cardiomyopathy   "
37734|NCT02791724|"     The trial aims to evaluate the effectiveness of a novel internet intervention (Desiconnect),     which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to     Persons with Epilepsy (PwE) and comorbid depression. Therefore, 200 PwE and a current     depressive disorder (major depressive disorder or dysthymic disorder) will be recruited and     randomized to two groups: (1) a control group, in which they may engage with any epilepsy     treatment (Care-as-Usual, CAU) and receive access to Desiconnect after a delay of three     months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately     receives six-month access to Desiconnect and may also use CAU. The primary outcome measure is     the depression scale of the Patient Health Questionnaire (PHQ-9), collected at three months     post-baseline.   "
37735|NCT02791711|"     The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal     Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.      Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the     safety and efficacy of administering O2. This device generates a continuous positive pressure     in the airways, to reduce the work of breathing. The sealing absence of the HFNC at the nasal     interface improves patient comfort and avoiding nasal trauma.   "
37736|NCT02791698|"     The investigators will conduct a prospective study, in which they will determine sensitivity,     specificity and diagnostic accuracy of late evening urinary free cortisol     concentration/creatinine and hair cortisol in differentiating Cushing's syndrome from     Pseudo-Cushing's syndrome.   "
37737|NCT02791685|"     The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation     program delivered via a smartphone application and regular telephone calls will lead to     improved patient outcomes as measured by functional capacity, improved patient compliance in     monitoring symptoms and medication adherence, improved self-efficacy and knowledge in     managing disease and, a decreased rate of hospitalization and re-admissions.   "
37738|NCT02791672|"     The pedicled latissimus dorsi flap is a piece of tissue taken from the back that is used to     reconstruct the breast after cancerous tissue is removed. Over the years, improvements in     surgical technique and pain control have decreased the length of stay in hospital after this     procedure. Recently, early discharge after breast reconstruction using another very similar     pedicled flap, called the transverse rectus abdominis flap, was shown to be safe,     patient-centered, and associated with significant hospital cost-savings by another Canadian     group.      With increasing pressure from hospital administrators to weigh financial considerations into     treatment decision making, doctors must test cost-saving strategies in order to ensure     patient satisfaction and safety. Here, we plan to evaluate patient safety, satisfaction and     cost efficacy in breast reconstruction using the pedicled latissimus dorsi myocutaneous flap.      We hypothesize that patient care planning can allow for safe and cost-effective same-day     discharge and improved patient satisfaction after autologous breast reconstruction using the     pedicled latissimus dorsi flap. After nearly 10 successful same-day discharges using this     flap, our experience at the Ottawa Hospital suggests that this practice is safe, has     increased patient satisfaction scores, decreased narcotic use, no short or long term     complications and is more cost effective compared to patients who stay overnight.      In the present study, we hope to quantify our results by demonstrating that same day     discharge is a cost effective strategy that does not compromise patient safety and     satisfaction.   "
37739|NCT02791659|"     X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not     only the patient, but the personnel of ERCP team may have the effect from the scattered ray.     According to the automatic beam adjustment function, the thicker object (eg. lying left     lateral) might produce higher scatter ray than thinner object (eg. lying prone). The     investigators evaluate the radiation exposure among ERCP personnel compare between patient's     2 different positions.   "
37740|NCT02791646|"     This trial is a sequential multiple assignment randomized trial (SMART), that will examine     response to differing doses of a behavioral cancer pain intervention (Pain Coping Skills     Training [PCST]) and subsequent response-based adjustments to doses. Cancer patients with     pain will initially be randomized to receive either PCST-Full or PCST-Brief. Participants who     do not report pain reduction to their initially assigned intervention will be re-randomized     to receive either maintenance or an increased level of intervention. Participants who report     pain reduction to their initially assigned intervention will be re-randomized to either a     maintenance dose or no further treatment. Intervention responses will be compared across     conditions using a standard two-sided, two-sample t-test. Techniques typically used for SMART     studies will be used to compare intervention dosage sequences across PCTS that adjusts to     initial dosage based on patient responses. The risk and safety issues in this trial are low     and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).   "
37741|NCT02791633|"     Observational feasibility study using Patient Reported Outcomes (PRO) to assess quality of     life and 'return to normal life' up to 1 year following emergency laparotomy   "
37742|NCT02791620|"     The objective of this study is to evaluate arm rejuvenation and tightening with a     nanofractional radiofrequency device, Venus viva, Venus concept, Toronto Canada. We recruit     20 subjects. All 20 subjects are treated with 3 sessions, 1 month interval with a nano     fractional radiofrequency device on the inner upper arm. We evaluate skin tightening using     %improvement of treated surface areas and skin elasticity using Dermalab the result at 3     months after the last treatment and clinical improvements evaluated by two board certified     dermatologist (using compared photos between before treatment and 3 months after the last     treatment).   "
37784|NCT02791074|"     This proposed study aim to:        1. Determine intra-LV pressure-time profile non-invasively using recently developed echo          Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF          subjects (both HFNEF and HFREF) compared to normal volunteers.        2. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.   "
37785|NCT02791061|"     The primary aims of this study are to 1. Develop an automated method of quantitation of RV     remodeling in terms of regional RV surface curvature and area strain and assess the     feasibility, repeatability and accuracy in normal subjects and patients with repaired TOF,     patients with PS      The secondary study aims of this study are to      1. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex     and age-matched controls 2, Assess the relationship of our proposed parameters to global RV     function and exercise capacity in repaired TOF patients and PS patient   "
37743|NCT02791607|"     HNSCC is the 4th highest incidence of cancer and 6th of cancer death of the males in Taiwan.     Because the patients were mainly middle-aged male, the disease eventually resulted in a huge     loss of labor force, productivity and a huge burden of family supports and medicinal costs.     Currently, the primary treatments of HNSCC are mainly surgery, radiotherapy, chemotherapy or     targeted therapy or concurrent chemoradiotherapy. Compared to oral cavity cancer, patients     with pharyngeal cancer would possibly harbor HPV infections and have better treatment     outcomes, prognosis and survival with clinically significance; however, the investigator's     reports showed quite the opposite prognostic value in oral cavity cancer. The inconsistent     data urges us to investigate further. Fortunately, in recent years, The investigator have     developed a new method for isolation and detection of CTCs in HNSCC patients.The     investigator's data found that high level of CTCs in patients with HNSCC and might be     associated with disease prognosis, response to treatment and distant metastasis. This novel     tool enhances the studies addressing on metastases or recurrence process in HNSCC patients.     However, the investigator did not focus whether if the dynamic change of CTCs and specific     surface markers on CTCs, such as P16+ CTCs are clinically meaningful.      Therefore, in the first year, the investigator will utilize the investigator's developing     device and protocol to isolate high-purity CTCs to further identify P16+ on CTCs. In the     following 2 years of the project, the investigator will enroll 150 freshly diagnosed patients     with oral cavity, oropharyngeal, hypopharyngeal and laryngeal cancer at all stages (75 P16+     and 75 P16- patients) and 30 healthy donors for cell line tests, and then analyze CTCs,     background white blood cells signals, and their initial biopsied tissue for P16 positivity     test. Further statistical tests with clinical conditions (disease status, treatment effects,     progression or distant metastasis and death) will be performed to elucidate their clinical     significance.Hopefully, the investigator will clarify the clinical significance of     circulating P16 expression status on CTCs by this study and provide a new biomarker for     clinical cancer care.   "
37744|NCT02791594|"     Up to 35 adult patients with metastatic melanoma will be enrolled in this study with a target     enrollment of 30 evaluable subjects who complete the baseline and an approximately 3 week FDG     PET/CT scans, they may also complete an FDG PET/CT after 10 weeks of pembrolizumab therapy.     Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then will be     asked to have one additional tumor biopsy and one additional blood draw for the purposes of     this imaging study. Subjects who are eligible for this imaging protocol will undergo a     baseline FDG PET/CT scan as part of their clinical restaging prior to starting new therapy. A     research FDG PET/CT will take place approximately 3 weeks post-therapy and a 3rd FDG PET/CT     scan will be done at more than 10 weeks after starting pembrolizumab, this scan may be done     as a clinical scan for evaluation of response or restaging after therapy, however, if it is     not ordered as a clinical scan it will be done as a research scan. Changes in FDG uptake will     be correlated with blood and tissue results from the patient's medical records and from the     data collected as part of the Penn Melanoma Tissue Collection Program and with long term     outcomes including progression free and overall survival.   "
37745|NCT02791581|"     This study is being done to see if patients receiving chemotherapy for breast cancer affects     the heart, the ability to exercise and fatigue when compared to patients who do not have     cancer.   "
37746|NCT02791568|"     The purpose of the study is to develop advanced ultrasound (U/S) and Magnetic Resonance     Imaging, known as MRI to study uteroplacental health. The goal of this study is to evaluate     the blood and oxygen flow to the placenta using advanced U/S and MRI testing.   "
37747|NCT02791555|"     The investigators are evaluating the effect of Pradaxa in comparison to warfarin on bone     turnover and bone density in men and women with atrial fibrillation.   "
37748|NCT02791542|"     This will be a single site, mechanistic study of asthmatic subjects and healthy,     non-asthmatic controls which will compare asthmatic smooth muscle cells to non-asthmatic     smooth muscle cells collected from bronchial biopsies.   "
37749|NCT02791529|"     The use of electrocautery for surgical skin incision in general surgery is known to decrease     post-operative pain. This study compares the use of scalpel and electrocautery for surgical     skin incision in open carpal tunnel release (OCTR).   "
37750|NCT02791516|"     A multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of 6     months treatment with Romosozumab compared to placebo by determining the percent changes in     bone mineral density   "
37751|NCT02791503|"     Irreversible electroporation (IRE) is a promising new ablation technique to fight pancreatic     cancer. The primary aim of the CROSSFIRE trial is to compare the efficacy (in terms of     overall survival) of FOLFIRINOX and IRE (experimental arm) to the efficacy of FOLFIRINOX and     stereotactic ablative radiotherapy (SABR) (control arm) in patients with locally advanced,     non-resectable, non-metastasized, pancreatic cancer (LAPC). Secondary outcomes are     progression free survival, safety/toxicity, immunomodulation, tumor marker Cancer Antigen     (CA) 19.9, quality of life (QoL), and total direct and indirect costs for each treatment arm     (cost-effectiveness analysis).   "
37752|NCT02791490|"     This trial is designed to evaluate, in adult participants with Type 2 diabetes mellitus     (T2DM) and inadequate glycemic control on sub-maximal metformin mono-therapy (1000 mg/day),     the effect of up-titration of metformin plus the addition of sitagliptin compared to     up-titration of metformin alone on glycemic control. The primary hypotheses of this study are     that up-titration of metformin to 2000 mg/day (1000 mg, twice daily [b.i.d]) plus the     addition of sitagliptin 100 mg/day provides greater reduction in hemoglobin A1C (A1C)     compared to metformin up-titration alone and that this treatment is safe and well-tolerated.   "
37753|NCT02791477|"     Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty     evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6     weeks, 3, 6, 12 and 24 months postoperative.   "
37754|NCT02791464|"     The pilot study investigates the potential benefits of the Transcendental Meditation program     in reducing trauma, including PTSD, in female prisoners. Subjects will be randomly assigned     to either the TM program or a wait list control group for a period of four months.   "
37755|NCT02791451|"     This is an open-label single-center 6-month prospective clinical trial predicting     exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep     in patients admitted to the pulmonary ward of the Turku University Hospital due to acute     exacerbation of COPD.   "
37756|NCT02791438|"     The purpose of this study is to evaluate the safety of administration of TAK-536 in pediatric     patients aged 6 to less than 16 years with hypertension.   "
37786|NCT02791048|"     This study aims to find out if music therapy is effective in improving the quality of life of     palliative care patients. It will do this by comparing palliative care patients who receive     music therapy with those who do not receive music therapy.   "
37787|NCT02791035|"     The purpose of this study is to examine the correlation between change of HbA1c, urinary     glucose excretion and other factors when ipragliflozin is added to preexisting therapy in     subjects with type 2 diabetes.   "
37757|NCT02791425|"     Objectives:      Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked     Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of     common patient needs in alert mechanically ventilated patients in the Intensive Care Unit     (ICU).      Specific Aim 2: To determine patient, family and bedside nurse satisfaction with     communication using the BCI device and elicit open-ended feedback to guide future device     improvements      Design:      Translational pilot study of a Steady State Visual Evoked Potential (SSVEP) based BCI system     to facilitate communication in intubated patients, with sequential use of the BCI device and     a picture board.      Selection of the primary self-identified primary patient need on the BCI device will be     compared to the icon selected on the picture board (reference standard). A patient     satisfaction survey will then be provided to the patient or a family member following use for     2 hours a day for 3 consecutive days.      Primary outcome: Accurate selection of the illustrative icon on the brain computer interface     representing the physical or emotional need self-identified by the patient as being the most     common trigger for communication with the bedside nurse during their admission.      Secondary outcome: Selection by patients or family of agree or strongly agree with the     statement The Brain computer interface device allowed me to communicate my needs to the     bedside nurse adequately.      Intervention: Use of the brain computer device in the ICU for communication for 2 hours a day     for 3 consecutive days      Control/ Comparator: Sequential use of a communication picture board for 2 hours a day for 3     consecutive days, on the same days that the BCI device is used Sample Size: 30 mechanically     ventilated but alert patients in the Intensive Care Unit   "
37758|NCT02791412|"     The purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary     intervention or coronary-artery bypass graft) in unprotected left main coronary artery     stenosis in Korea.   "
37759|NCT02791399|"     This is a randomized controlled trial of a multifaceted intervention designed to improve the     safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a     multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid     safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship,     and (c) explore to what extent ISOP is associated with changes in pain and pain-related     function.   "
37761|NCT02791373|"     The purpose of this study is to determine whether the efficacy of gemcitabine is comparable     with the efficacy of the standard chemotherapy with vinorelbine for mobilization of     autologous stem cells in myeloma patients   "
37762|NCT02791360|"     Through this study, the investigators believe to describe more accurately the damage caused     by brain radiation therapy in the long term.   "
37763|NCT02791347|"     Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated     with severe gastrointestinal toxicity, commonly compromising patients' food intake,     nutritional status and functioning level. Malnutrition has been associated with worse     functional status, reduced survival, increased rate of infections, complications,     hospitalizations, and therapy toxicity in oncology patients.      To date, there is no Randomized Controlled Trials (RCT) assessing the impact of a nutrition     intervention on SCT patients who remain at risk of malnutrition even 100 days post SCT. The     proposed study is a single center, prospective, RCT with a parallel design that aims to     assess the impact of a nutrition intervention on the nutritional and functional statuses of     SCT recipients 100 days post SCT.   "
37764|NCT02791334|"     The main purpose of this study is to evaluate the safety and tolerability of anti-programmed     cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced     refractory solid tumors.   "
37765|NCT02791321|"     Frailty is a age dependent physiological state of vulnerability. Frailty is screened by the     phenotypic model (5 clinical criteria) or the cumulative model (various clinical and     biological criteria). Currently, aging with autism spectrum disorder and mental retardation     (ADS-MR) is poor described. Nevertheless many data indicate that people with ADS-MR may     present an early aging.      Principal aim of this study is to determine if frailty in people with ADS-MR aged over 20     years depend on age. Secondary aims are to evaluate frailty prevalence, to describe with     details health according to age, and to verify the frailty index validity for predicting     falls, hospitalisation and death, in this population of ADS-MR patients aged over 20 years.      This monocentric and prospective study will include 60 ADS-MR patients aged over 20 years and     living in Languedoc-Roussillon's medico-social care homes. Patients are evaluated at the time     of inclusion. Frailty index is calculated from 104 clinical and biological criteria.     Furthermore the investigator staff collect data about ADS severity (CARS), adaptative and     intellectual functionning (Vineland), and psychiatric and somatic comorbidities (Reiss scale,     DSQIID and CIRS). Falls, hospitalisations or death occurrence is then collected every year     during 5 years.      The connection between frailty index and age will be studied using linear regression. The     frailty index validity will be analysed using ROC curves. Modelisation of the falls,     hospitalisations or death risk in the 5 years after the initial evaluation will help in     identification of the more frailty predictive criteria.   "
37766|NCT02791308|"     The purpose of this study is to compare the safety and efficacy profiles of Watson     Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America     LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two     active creams over that of the placebo (Vehicle of test product), in the treatment of mild to     moderate atopic dermatitis.   "
37767|NCT02791295|"     The purpose of the study is to determine whether a personalized lifestyle intervention     focused on diet and physical activity reinforcement is effective in avoiding weight gain in     the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic     patients.   "
37768|NCT02791282|"     Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a     diagnostic strategy for patients with suspected CTEPH where positive findings are verified     with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography     (CTPA)   "
37769|NCT02791269|"     This is an expanded access, multicenter, national, open-label, and non-randomized study to     analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen     (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48     weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free     follow-up period.   "
37770|NCT02791256|"     This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of     increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6     CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin.     The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24     weeks).   "
38412|NCT02782845|"     This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or     Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT)     as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose     of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each     treatment cycle.   "
37773|NCT02791217|"     MiRNAs are small (~19-25 nucleotides) non-coding RNA molecules that bind to mRNA in a     sequence-specific manner. MiRNAs regulate gene expression at the post-transcriptional level.     MiRNAs regulate critical cell processes such as metabolism, apoptosis, development, cell     cycle, hematopoietic differentiation and have been implicated in the development and     progression of several types of cancers, including hematological malignancies.     Over-expression, amplification and/or deletion of miRNAs and miRNA-mediated modification of     epigenetic silencing can all lead to oncogenic pathways.      Hematologic cancers, which are caused by the malignant transformation of bone marrow cells     and the lymphatic system, are usually divided into three major clusters: leukemia, lymphoma,     and multiple myeloma. To date, some of the hematological malignancies are very aggressive     that early diagnosis is essential for improving prognosis and increasing survival rates.     However, current diagnostic methods have various limitations, such as insufficient     sensitivity, specificity, it is also time-consuming, costly, and requires a high level of     expertise, which limits its application in clinical contexts. Thus, development of new     biomarkers for the early detection and relapse of hematological malignancies is desirable.      Some of the innate properties of miRNAs make them highly attractive as potential biomarkers.     MiRNAs can be readily detected in small volume samples using specific and sensitive     quantitative real-time PCR; they have been isolated from most body fluids, including serum,     plasma, urine, saliva, tears and semen and are known to circulate in a highly stable,     cell-free form. They are highly conserved between species, allowing the use of animal models     of disease for pre-clinical studies. Furthermore, tumor cells have been shown to release     miRNAs into the circulation and profiles of miRNAs are altered in the plasma and/or serum of     patients with cancer. A growing number of publications confirm that miRNAs can be a useful     biomarker for hematological malignancies diagnosis and progression.   "
37774|NCT02791204|"     This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization     treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the     disease can progress more quickly than in patients without diabetes.   "
37775|NCT02791191|"     The main purpose of this study is to evaluate the safety and the effect on brain tau of the     study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.   "
37776|NCT02791178|"     The overall objective of this research proposal is to use OCT to investigate those     morphological culprit plaque characteristics associated with the risk of developing MVO in     reperfused STEMI patients.   "
37777|NCT02791165|"     There is an optimal day on which to perform the CMR scan which allows one to capture the     information required to assess the dynamic changes in the reperfused STEMI patient. The main     objective is to characterise the dynamic changes in LV function, MI size, myocardial edema,     MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute     reperfused STEMI in order to identify the optimal day for performing the CMR scan.   "
37778|NCT02791152|"     A prospective cohort of relatively healthy individuals, using comprehensive clinical     information, advanced imaging (including cardiac MRI), cardiovascular exercise physiology,     metabolomics and genetic analysis. These findings will be correlated with adverse clinical     outcomes including death, stroke and myocardial infarction. In selected cases, follow-up     imaging and biomarker samples will also be obtained. These studies will enable us to begin to     address a critical gap in our knowledge as to how best to interpret the very large amount of     cardiovascular tests done in Singapore and how to better to predict outcomes and manage     healthcare costs in our local populations   "
37779|NCT02791139|"     The investigators aim to investigate the association of midlife dietary and lifestyle factors     on cardiac functional changes in the elderly. The investigators hypothesize that even in     those without clinically manifest cardiovascular disease, the extent of underlying     abnormalities in cardiovascular structure and function in the elderly would be independently     related to midlife dietary and lifestyle factors.   "
37780|NCT02791126|"     Heart failure is a major health care burden. It can occur with either normal or reduced LV     ejection fraction, depending on different degrees of ventricular remodelling. The     investigators recently published a new method, curvedness-based imaging. The investigators     have also reported the diagnostic utility of curvedness-based imaging in various cardiac     diseases. The investigators now propose to prospectively assess curvedness-based imaging for     diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction,     and examine left ventricular systolic and diastolic function and predicts the prognosis in a     cohort of HF patients.   "
37781|NCT02791113|"     The investigators propose to develop a computational framework involving a novel automatic     image segmentation algorithm based on CTA images, an artery model reconstruction algorithm     for stenosis detection, and quantification of severity of stenosis in terms of area stenosis.   "
37782|NCT02791100|"     Young children in Ethiopia lack sufficient protein and micronutrients for growth and     development. The overall purpose is to assess the effects of promoting egg and eggshell     powder consumption on improving the nutritional status of children 6 to 15 months in Halaba     Special Woreda, Southern Ethiopia. The hypothesis is that providing chickens to produce eggs     (egg and eggshell) for young children will improve growth in otherwise malnourished young     children. Upon providing chickens, the nutritional status of young children prior and after     the intervention (by 6 months) will be assessed. Identification of the knowledge, attitude     and practices (KAP) of mothers on egg and eggshell powder consumption by their children     before and after the intervention in the intervention group will be done. Caregivers will be     instructed to give each child 1 egg (cooked) and 1/4 bottle cap of eggshell (500 mg     calcium) per day in the intervention. Hemoglobin will be measured as an indicator of overall     nutritional status. Throughout the study, any problems arising in keeping chickens will be     recorded in order to assess the feasibility and practicality of raising chickens as way to     improve nutritional status of young children. The study is novel in that investigators are     providing a way to have increased protein, increased micronutrients, and use of eggshell as a     source of calcium.   "
37783|NCT02791087|"     CFD simulations in this study provide detailed hemodynamics information, which cannot be     obtained from cardiac images alone. The investigators hypothesize that our proposed     simulations will provide strong correlation between hemodynamic parameters, such as WSSG and     SPA, and clinically identified graft stenosis. These correlations will allow the     investigators to identify the future patients at high risk of graft stenosis and lead to     future researches on optimizing and refining surgical plans, such as finding optimal proximal     and distal anastomoses locations, optimal graft length and diameter, which could lead to     improved longevity of the graft. Once CFD coupled shape optimizer is validated, it could be     part of the surgical simulator to help in training the next generation physicians. It could     provide new viewpoints for assessing whether some modified surgical techniques are better or     not. It could also aid in designing and evaluating the vascular medical devices, including     stent, artificial graft, and etc., which would lead to better surgical outcome.   "
37788|NCT02791022|"     Atrial fibrillation is a common disease in the aging population that has severe implication     if left untreated as it leads to embolic stroke and other embolic phenomenon. Embolic stroke     in particular has severe implications to our community as the cost of care for such immobile     patients can be extremely high. Atrial fibrillation typically begins as Paroxysmal atrial     fibrillation (PAF), which makes early detection extremely difficult as the PAF may only occur     transiently in the initial stages. Long term continuous ECG monitoring is currently required     over weeks to detect early PAF. Current devices typically need to be implanted (loop     recorders) to be sensitive enough to detect infrequent episodes of PAF. New generation ECG     remote devices (non-invasive) are however now available that are wearable over long periods     and can send data directly to a database for centralized collection and analysis of the data.     The aim of this study will be to use such a device to evaluate the incidence of PAF in     different population of patients, with each patient wearing and sending continuous ECG data     for periods of a week or more to a central database, across several public hospitals in     Singapore.   "
37789|NCT02791009|"     To build on Singapore's competitive advantages in advanced cardiac imaging, genetic and     molecular studies to develop an integrated one -stop platform spanning from human to large     and small animal models, dedicated to deepening the understanding of CV disease progression,     discovery of new targets and repurposing of drugs.   "
37790|NCT02790996|"     The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised     dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with     late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms   "
37791|NCT02790983|"     Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients     will be collected and evaluated to investigate the prognostic factors which influence     survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups     of patients diagnosed with primary spinal column tumors.   "
37792|NCT02790970|"     Depression is a very common, serious and in some cases life‐threatening condition, affecting     around 350 million people globally. Approximately 11% of citizens in the European Union     suffer from depression at some point in their lives. Depression is associated with     significant socio-economic costs and has been predicted to become the greatest cause of     disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30     million patients with depression in Europe, with aggregated economic costs of approximately     €92 billion . Improvements in managing the treatment of depression are urgently needed to     improve patient outcomes, contain rising healthcare costs, improve workplace productivity and     help to address global economic and societal challenges.      While a range of effective antidepressant medications are available to treat depression, it     takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether     the treatment is working. However, surprisingly, more than 50% of patients fail to respond to     the first antidepressant treatment they are prescribed. Therefore, it often takes several     months to identify an effective antidepressant treatment for the majority of patients with     depression. During this time a patient's ability to work and function socially is severely     impaired. Individuals may be absent from work for many weeks or months and this places a     substantial burden on the economy and on healthcare resources.   "
37793|NCT02790957|"     Chronic non-healing wounds represent a major source of morbidity, disability, and mortality     in diabetic patients. Diabetes is the leading cause of non-traumatic limb amputations     worldwide. Many patients with ischemic or neuroischemic wounds are not candidate to     surgical/endovascular revascularization, owing to anatomical vascular reasons or for the     underlying conditions and co-morbidities. Therefore, identification of novel medical     treatment strategies to improve wound healing in diabetic patients is a major challenge for     clinicians, researchers, and health care systems.      Defects in bone marrow (BM)-derive stem and progenitor cells, including EPCs (endothelial     progenitor cells), contribute to diabetic complications. Stem cell mobilizing agents have     been previously studied as an adjunctive therapy for critical limb ischemia and chronic     non-healing wounds in diabetic and non-diabetic patients, as well as for the treatment of     diabetic wound infections . Meta-analyses of such studies indicate that stem cell     mobilization in these clinical conditions is safe and potentially effective in improving     surrogate outcome measures and hard endpoints (such as rates of wound healing and     amputation).      This study plans to evaluate whether a single injection of Plerixafor improves wound healing     in diabetic patients with stage III-IV (neuro)ischemic wounds.   "
37794|NCT02790944|"     The primary objective of the study will be to estimate the prevalence of germline mutations     in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic     ductal adenocarcinoma.   "
37795|NCT02790931|"     The main objective of this trial is to investigate the effects of foot muscle strengthening     in daily activity of patients with diabetic neuropathy.   "
37796|NCT02790918|"     In this study, study team aim to i) evaluate the accuracy of 3D IVS curvedness for prediction     of RV systolic pressure (RVSP), mean pulmonary artery pressure (mPAP) and pulmonary vascular     resistance (PVR) with RHC; ii) evaluate the usefulness of 3D IVS curvedness for predicting     the response to vasodilator challenge with RHC, in patients clinically suspected or known to     have primary PH.   "
37797|NCT02790905|"     The objective of this study is to validate the Patient Health Questionnaire-9 (PHQ-9) and the     Refugee Health Screener-15 (RHS-15) screening tools for depression in pregnant and     post-partum migrant women on the Thai-Myanmar border.   "
37798|NCT02790892|"     The Creative Arts Diabetes Initiative will offer facilitated art therapy with a     group/peer-support environment to two groups of youth/young adults, one with type 1 diabetes,     and one with type 2 diabetes. This environment intends to meet youth where they are,     promote universality, hope and self-understanding, has the potential to be therapeutic and     allows youth to express and learn about themselves and each other while developing healthy     coping skills and address their fears and concerns.   "
37815|NCT02790671|"     Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of     single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.   "
37816|NCT02790658|"     Investigate the bioavailability of the main flavonoid, their colonic transformation and     untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice     by humans.   "
37799|NCT02790879|"     The main objective of register-SAFETIM is to assess the impact of the transition from     pediatric to adult cystic fibrosis care center on changes in lung function and nutritional     status of patients.      This is a multicenter, observational, longitudinal, with analysis of the French national     registry data of patients with cystic fibrosis.      Our study will assess the clinical features of adolescent patients with cystic fibrosis     during the transition from pediatric care to adult care. It will explore factors associated     with the impact of the transition on the clinical course of adolescent patients (respiratory     and nutritional functions).   "
37800|NCT02790866|"     This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision     aid designed to facilitate informed decision making about participation in lung cancer     screening among individuals at high risk of lung cancer due to heavy cigarette smoking.   "
37801|NCT02790853|"     The goal of this clinical research study is to learn if new types of imaging devices can help     doctors decide if a lesion in the mouth is pre-cancerous or cancerous.   "
37802|NCT02790840|"     The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three     gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK     of three gefapixant formulations; and, to assess the safety and tolerability of gefapixant.   "
37803|NCT02790827|"     This study evaluates the effectiveness of a multi-pronged intervention in reducing and     preventing violence against women and children compared to a treatment as usual control group     among families living in Lusaka, Zambia.   "
37804|NCT02790814|"     Annually, an estimated 2.6 million still births occur half of which die during labor and     delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth     due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths     take place in low-income countries where the provider/patient ratio is low and fetal     monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify     fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these     low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called     Moyo, using ultrasound technology, was developed to be strapped on the mother during labour.     This project will compare the effectiveness of automatic use of Moyo versus intermittent use     of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized     control study, at Haydom Hospital, Tanzania.   "
37805|NCT02790801|"     The purpose of this study is to evaluate the management of chronic heart failure patients     with atrial fibrillation, to collect data on compliance with clinical guidelines and the     prevalence of long-term anticoagulant therapy,complications. The results will be used to     develop most rational therapeutic and diagnostic strategies to improve clinical outcomes of     such patients.   "
37806|NCT02790788|"     Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors     plan to conduct a prospective, randomized, placebo controlled evaluation of stress-dose     steroids efficacy with repect to early postresuscitation hemodynamics, heart function, brain     perfusion, and inflammatory response in vasopressor-requiring cardiac arrest. Patients will     also be followed for organ dysfunction, potential, steroid-associated complications, and     functional outcome at hospital discharge.   "
37808|NCT02790762|"     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord     mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.   "
37809|NCT02790749|"     Although evidence is amassing regarding the role of intra-articular pathology in the surgical     management of adolescents and adults with hip dysplasia, the optimal method of detection and     especially management of this pathology remains unclear. No studies exist to compare clinical     outcomes and hip survival between arthroscopy and arthrotomy in patients with mechanical hip     pain undergoing periacetabular osteotomy (PAO) for dysplasia, and this is what the     investigators aim to achieve in the current prospective randomized surgical trial.   "
37810|NCT02790736|"     The study will test the efficacy of propranolol or placebo, administered after retrieval of a     previously acquired public speaking fear, in reducing fear and avoidance of public speaking.   "
37811|NCT02790723|"     This study seeks to determine the safety of three different doses of sc-rAAV2.5IL-1Ra     delivered by intra-articular injection into one knee joint of patients with moderate OA of     the knee.   "
37812|NCT02790710|"     The study will test the efficacy of propranolol or placebo, administered after reactivation     of a previously acquired obsessive-compulsive disorder (OCD) fear, in reducing fear and     avoidance in OCD.   "
37813|NCT02790697|"     This study aims at validating the accuracy of the new indirect calorimeter (Quark RMR 2.0,     COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will     only be conducted in Geneva center.      The measurements made with the new calorimeter will be compared to the measurements by the     mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition     analysis.   "
37814|NCT02790684|"     This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance     of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age,     inclusive. The radiolabeled investigational medicinal product will be administered to 12     healthy male subjects in 2 cohorts of 6 subjects each.   "
37836|NCT02790385|"     Children with neuromuscular disorders such as cerebral palsy, children with kyphosis and     post-traumatic scoliosis have higher infection rates after scoliosis surgery than healthy     children who undergo scoliosis surgery. The purpose of our study is to compare the effect of     NPWT on infection rates when compared to standard gauze dressing. Participants will be     randomized to the NPWT or standard dressing group. We will compare infection rates     between the two groups. We hypothesize participants in the NPWT group will have a lower     infection rate.   "
37837|NCT02790372|"     This study evaluates the effect of using comprehensive geriatric assessment in combination     with case conferences on the prevalence of neuropsychiatric symptoms (also known as     behavioral and psychological symptoms of dementia) in Norwegian nursing homes   "
38198|NCT02785666|"     The investigators aim at investigating the efficacy of grazoprevir/elbasvir ±ribavirin in     HIV-positive MSM participating in the SHCS in a broader setting of coinfected MSM. The study     pursues a comprehensive approach of a treat, counsel and cure strategy exploring the impact     of such a strategy in a representative HIV/HCV-coinfected MSM population. This study is a     nested project of the Swiss HIV Cohort Study entitled The Swiss HCVree Trial.   "
37817|NCT02790645|"     Diabetes mellitus is a chronic disease of high socio-health relevance for their clinical and     economic implications (risk of complications, disability ...) (healthcare costs). Strict     glycemic control and intensive treatment and support have shown long-term patient with type 1     diabetes mellitus (DM1) improved health. The intensive insulin therapy involves the     administration of insulin through 3 or more injections per day (MDI), or through a continuous     subcutaneous insulin infusion (CSII). New technologies applied to the treatment of DM1, such     as telemedicine, could bring benefits to patients. The available scientific evidence to date     shows that telemedicine systems have beneficial or neutral effects on glycemic control,     expressed in terms of HbA1c in patients with type 1 diabetes treated with MDI or CSII. They     have also shown not to worsen the quality of life and reduce the costs associated with the     care of these subjects. However, studies published to date are generally short follow-up,     small sample size, and have not evaluated other biological parameters such as glycemic     variability, inflammatory markers and markers of oxidative stress as well as a psychological     assessment including depression, anxiety, Diabetes-related distress and fear of hypoglycemia.     It has been designed a randomized crossover 18 months in order to study the effect of a     telemedicine program in a group of subjects with DM1 in CSII on clinical variables of     metabolic control variables, including parameters of glycemic variability, markers of     inflammation and oxidative stress, psychological variables and quality of life, and     associated costs.   "
37819|NCT02790619|"     The purpose of this study is to determine if a new technology applied while listening to a     mindfulness meditation tape can affect one's ability to achieve a state of mindfulness. The     new technology is called transcranial direct current stimulation, or tDCS.   "
37820|NCT02790593|"     Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy     which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an     alternative solution for the long-term treatment of patients with venous ulceration. This is     a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to     determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for     patients with venous ulceration compared to bandaging. Secondary outcome measures include     whether the Juxta-Cures™ device improves patient compliance and quality of life compared to     bandaging, and whether the Juxta-Cures™ device is cost effective compared to bandaging.   "
37821|NCT02790580|"     Background: The investigators previously studied the addition of low-dose, short-course     sunitinib to pre-operative chemotherapy in the neoadjuvant setting in newly diagnosed breast     cancer patients with measurable primary breast tumor in a phase Ib/II study at the National     University Cancer Institute, Singapore. These data showed that the addition of sunitinib     improved tumor vascularization as hypothesized with enhanced short-term treatment response.     However, pathological complete response rate after 4 cycles of chemotherapy was not superior     to standard chemotherapy, and may be attributed to dose delays from increased     myelosuppression with the addition of sunitinib. The investigators hypothesize that this     promising regimen may be further optimized with the use of growth factor support. The     investigators thus plan to study the addition of low-dose, shortcourse sunitinib to     dose-dense doxorubicin/cyclophosphamide (ddAC) administered every 14 days, supported by     pegfilgrastim.      Aim: To confirm that the addition of 12.5mg sunitinib for 5-7 days can be added before each     cycle of ddAC (delivered every 14 days, supported by pegfilgrastim) without compromising dose     intensity, in phase II open label single arm part of the study, followed by a phase II     randomized study to compare the pathological complete response rate of ddAC versus sunitinib     + ddAC in stage I-III HER2 negative breast cancer patients in the neoadjuvant setting.      Methods:A single-centre study comprising two phases: a. Phase II open label single-arm study     that will enroll newly diagnosed stage I-IV HER2 negative breast cancer patients receiving     either neoadjuvant chemotherapy (stage I-III patients) or first-line palliative chemotherapy     (stage IV patients). All patients will be treated with 4 cycles of ddAC at standard doses     (60/600mg/m2) every 2 weeks, supported by subcutaneous pegfilgrastim 6mg, to be administered     24-36 hours after each dose of chemotherapy. Low dose sunitinib at 12.5mg daily orally will     be administered for 7 days prior to cycle 1 ddAC, and for 5 days prior to each subsequent     cycle of ddAC. b. Phase II randomized study that will enroll newly diagnosed stage I-III HER2     negative breast cancer patients receiving neoadjuvant chemotherapy before definitive breast     cancer surgery. Eligible patients will be randomized 1:1 to 4 cycles of ddAC with or without     intermittent sunitinib in patients with measurable primary breast cancer who are receiving     preoperative chemotherapy.   "
37822|NCT02790567|"     The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical     critically ill patients. If the use of rapid immunological diagnostic methods and pretest     scoring systems has been proposed in the medical intensive care unit (ICU), none of these     methods have been specifically evaluated in the diagnosis of HIT in surgical patients.   "
37823|NCT02790554|"     Annually, an estimated 2.6 million still births occur half of which die during labor and     delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth     due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths     take place in low-income countries where the provider/patient ratio is low and fetal     monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify     fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these     low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called     Moyo, using ultrasound technology, was developed to be strapped on the mother during labour.     This project will compare the effectiveness of automatic use of Moyo versus intermittent use     of hand-held Doppler in detection of abnormal fetal heart rate, through a randomized control     study, at the University hospital, Dar es Salaam, Tanzania.   "
37824|NCT02790541|"     Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis,     increased tissue blood flow and oxygenation correlated with tissue function.      Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned     organs associated with aging-related malfunctions due to restored mitochondrial function,     mobilization of stem cells and induction of angiogenesis.   "
37825|NCT02790528|"     The purpose of this study is to evaluate whether statin is effective in the treatment of     vasospastic angina.   "
37835|NCT02790398|"     The aim of this study is to assess the differential effect of two transdiagnostic treatment     protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized     pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified     Protocol; and b) a version of this protocol that also includes a specific component to     address the regulation of positive affect (TTP+PA). Another aim was to assess the     acceptability of both treatments by patients. It was hypothesized that the intervention would     result in significant differences in favor of the TTP+PA protocol in all measures. Regarding     acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted     by the two groups of participants.   "
37855|NCT02790138|"     The purpose of this study is to assess the efficacy and safety of vedolizumab intravenous     (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative     colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous     antibiotic treatment.   "
37826|NCT02790515|"     This study seeks to examine treatment therapy that will reduced regimen-related toxicity and     relapse while promoting rapid immune reconstitution with limited serious     graft-versus-host-disease (GVHD) and also improve disease-free survival and quality of life.     The investigators propose to evaluate the safety and efficacy of selective naive T-cell     depleted (by TCRɑβ and CD45RA depletion, respectively) haploidentical hematopoietic cell     transplant (HCT) following reduced intensity conditioning regimen that avoids radiation in     patients with hematologic malignancies that have relapsed or are refractory following prior     allogeneic transplantation.      PRIMARY OBJECTIVE:        -  To estimate engraftment by day +42 post-transplant in patients who receive          TCRɑβ-depleted and CD45RA-depleted haploidentical donor 30ogenitor cell transplantation          following reduced intensity conditioning regimen without radiation.      SECONDARY OBJECTIVES:        -  Assess the safety and feasibility of the addition of Blinatumomab in the early          post-engraftment period in patients with CD19+ malignancy.        -  Estimate the incidence of malignant relapse, event-free survival, and overall survival          at one-year post-transplantation.        -  Estimate incidence and severity of acute and chronic (GVHD).        -  Estimate the rate of transplant related mortality (TRM) in the first 100 days after          transplantation.   "
37827|NCT02790502|"     Globally, about one-third of edible food is lost or wasted 1. Wasted food depletes resources     used to produce the food (as a matter of definition, produce includes all activities to     distribute, package and prepare food for human consumption at any venue, but does not include     growing, transporting and processing), deprives hungry people from needed nutrition and     represents the most common (>20%) and most environmentally deleterious component (in terms of     greenhouse gas) of US landfills3-6. The Organization for Economic Co-operation and     Development (OECD) identified reducing FW as a key to increasing global food security (OECD     2011) 7. The Obama Administration recently announced a first ever FW reduction goal for the     United States of 50% by 2030. USDA and EPA will pursue this goal via partnerships with the     private sector, charitable and faith-based organizations, as well as state, local and tribal     governments.      In developed economies, consumers are the largest source of FW via home preparation and     dining out2, 8. In order to achieve FW goals, we must anticipate how consumer FW generation     and handling decisions will respond to proposed policies and interventions. However, there     exist substantial barriers to measuring consumer FW: existing methods have high respondent     burden and yield biased measurements of FW generation9-11. In this project we will test a     smartphone application (app) for measuring household FW.   "
37828|NCT02790489|"     The objectives of this clinical study are to determine the tolerance of dietary supplement     Valedia (blend of plant extracts) through the evaluation of several parameters :        -  Various blood biological parameters for tolerance (preprandial): blood glucose, insulin,          fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol,          oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine,          urea.        -  Urinary parameters: urea, creatinine.        -  Hemodynamic parameters: heart rate and blood pressure.        -  Cardiac function: ECG.        -  Weight.   "
37829|NCT02790476|"     In collaboration with the San Diego Medical Examiner's Office and the State of California's     controlled Substance Utilization Review and Evaluation System (CURES), the investigators     propose to review opioid poisonings over the past 12 months and will send letters to     prescribers in California when at least one of the provider's prescription(s) was filled by a     patient who died of an opioid poisoning in San Diego County. The letters will be     non-judgmental and factual, explaining that a patient of the provider who was being treated     with prescription narcotics died of an opioid poisoning. The letter will also encourage     judicious prescribing including use of the CURES system before prescribing. The investigators     will evaluate physician prescribing practices over 24 months 12 months pre- and 12 months     post-letter using data from the CURES database. The investigators' hypothesis is that letters     will make the risk of opioids more cognitively available and that physicians will respond by     prescribing opioids more carefully. This will result in fewer deaths due to misuse and more     frequent use of the CURES system.   "
37830|NCT02790463|"     The overarching goal of the investigators project is to identify best practices in gout and     hyperuricemia management, translate these evidence-based practices into a highly     generalizable strategy for optimal delivery of gout care, and implement and evaluate such a     strategy in a large, population-based healthcare setting. With the use of novel but     readily-accessible technology, the investigators will examine the use of a novel,     large-scale, and relatively low-cost pharmacy-based intervention, with the goal of optimizing     urate lower therapy (ULT) in chronic gout treatment.   "
37831|NCT02790450|"     Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant     role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this     channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known     inhibitor of the TMEM16A channel and is used in patients with gout.      In this pilot study the investigators plan to investigate if Benzbromarone has an acute     effect on the pulmonary arteries in humans. This will be investigated within the frame of a     right heart catheterization performed in patients with known PAH due to clinical reasons. The     investigators hypothesize that the application of Benzbromarone leads to pulmonary     vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In     addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge     pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons     patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes     upon NO and Benzbromarone may be compared.   "
37832|NCT02790437|"     The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients     who are on the waiting list for kidney transplant and have previously undergone     desensitization unsuccessfully or in whom effective desensitization will be highly unlikely.     At study entry, the patients will have an available deceased or live donor with a positive     crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific     Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.   "
37833|NCT02790424|"     Parameters, sequences or paradigms optimisation in view of data quality and relevancy     improvement.   "
37834|NCT02790411|"     Parameters, sequences or paradigms optimisation in view of data quality and relevancy     improvement.   "
37838|NCT02790359|"     The safety and effectiveness of esophagogastroduodenoscopy and colonoscopy in the detection     of gastrointestinal-tract pathology in children has been established during the last three     decades. Insufflation of the intestinal tract, usually with room air, is necessary to improve     visualization during the procedure; however, air in the bowels can also result in abdominal     distension and increased pain. This potential discomfort associated with upper endoscopy and     colonoscopy may be an important barrier to patients undergoing this procedure. Insufflation     with carbon dioxide is another method used in endoscopic procedures for distention of the     lumen and is currently used at the Children's Hospital of Wisconsin based on provider     preference. The aim of this study is to perform a randomized controlled trial comparing     insufflation with room air to carbon dioxide in patients undergoing routine upper endoscopy     and colonoscopy. The investigators primary outcome is measurement of patient comfort level as     measured by pain scores during recovery. The investigators hypothesize that carbon dioxide     insufflation during endoscopy and colonoscopy improves patient comfort level as compared with     insufflation with room air. Secondary outcome measures include changes in end tidal carbon     dioxide, time to discharge, duration of colonoscopy and cecal intubation rate, changes in     abdominal girth, rescue pain medications used during recovery and post-procedure events. This     is a prospective randomized single-blinded study. The investigators will recruit consecutive     patients, between the ages of 8 and 21 years, scheduled for elective outpatient upper     endoscopy and colonoscopy at children's hospital of Wisconsin from March 2015 until we reach     target population numbers. The investigators will exclude all inpatients, non-English     speaking patients, children under 8 years of age, patients undergoing colonic manometry     studies, and patients with hemodynamic instability, gastrointestinal bleeding, acute abdomen,     previous colectomy, oxygen-dependent pulmonary disease and obstructive sleep apnea requiring     the use of continuous positive airway pressure device. On the basis of a computer-generated     randomization scheme in a 1:1 ratio, patients will be assigned to receive room air or carbon     dioxide for insufflation during colonoscopy. Power calculation was done and determined that     we will need to enroll 100 patients in each arm of the study. Informed consent will be     obtained from all patients by the endoscopist or gastrointestinal fellow.   "
37839|NCT02790346|"     This study should refine our surgical indications and to establish a decision tree of medical     and surgical treatment of this common and troublesome strain functionally which is     equino-varus.   "
37840|NCT02790333|"     The purpose of this trial is to establish an objective criterion for assessing pancreatic     stump texture, and unify stapler cartridge according to pancreatic stump texture and     thickness.   "
37841|NCT02790320|"     The purpose of this study was to evaluate the efficacy and safety of eribulin in standard     clinical practice in patients with locally recurrent or metastatic advanced breast cancer.   "
37842|NCT02790307|"     Tibial nerve stimulation (TNS) has been recognised as a safe and effective treatment for the     management of overactive bladder (OAB) symptoms. The aim of this study was to evaluate     safety, acceptability and pilot efficacy of transcutaneous TNS using a novel device.   "
37843|NCT02790294|"     This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI)     in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the     early postoperative period (within 72 hours after surgery). The purpose of this study is to     see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI.      In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients     will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.   "
37844|NCT02790281|"     The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with     active moderate to severe ulcerative colitis or Crohn's disease.   "
37845|NCT02790268|"     To report the Ultrasound Biomicroscopic findings following Cionni Ring bag fixation and     in-the-bag IOL Implantation. To assess the relationship of the Bag and Cionni ring     positioning in relation to surrounding ocular structures, in pediatric eyes   "
37846|NCT02790255|"     The whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis     as a surrogate marker of brown adipose tissue (BAT) activation.      The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified     using an IR imaging device, and that this IR energy output may be correlated to the increased     energy expenditure quantified by the whole body calorimeter.   "
37847|NCT02790242|"     The purpose of this study is to gather information on patients who have heart failure and are     eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular     assist device (VAD) or 2) heart transplant. the study seeks to determine which patient     populations benefit from heart transplant or ventricular assist device. This will allow to     offer the state-of-the-art care to the patients in heart failure.   "
37848|NCT02790229|"     The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®)     compared to a standard rehabilitation protocol in patients with tibial plateau or ankle     fractures with six weeks of partial weight bearing.   "
37849|NCT02790216|"     Objective:      To focus the high dose radiation to the gross tumor in the prostate while maintaining     adequate dose for control of microscopic disease elsewhere in the prostate.      In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the     clinical setting the investigators planned a study of Focused therapy with a primary endpoint     of accurate localization of the high risk region. This is a pilot study of dose painted     permanent I-125 seed implant to verify absence of tumor cells outside a high risk region     using multi-parametric MRI and deformable TRUS registration. The high risk region will be     dose painted to 160 Gy and the rest of the prostate will receive the normal prescription     dose.   "
37850|NCT02790203|"     Perioperative Celecoxib to promote bowel movement and to reduce post-operative pain after     elective colonic resection.   "
37851|NCT02790190|"     This is a perspective, multicenter,randomized controlled trial to compare the efficacy and     safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in     patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS)     will be done as defined in the protocol.   "
37852|NCT02790177|"     The objective of study is to determine the effect of hyaluronic acid on the formation of     post-operative adhesions. It will be a randomized control trial comparing the product against     normal saline.   "
37858|NCT02790099|"     Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital     stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective     pain control. However, it is associated with significant side effects including nausea,     vomiting and itchiness. Also, it is not suitable in all patients, for example, those with     morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves     injection of local anaesthetic agents into the rectus sheath space before closure of the     wound. It has been shown to provide adequate pain control with less systemic side effects.     The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and     intrathecal morphine in post-Caesarean section pain control.   "
37864|NCT02790021|"     Rationale: Breast cancer-related lymphedema (BCRL) is one of the most underestimated     complications of breast cancer treatment with a reported incidence of 30% to 40% after     axillary lymph node dissection (ALND) and 7% after sentinel lymph node biopsy (SLNB).     Although the axillary treatment regimens are changing with a focus on less aggressive     axillary treatment in order to reduce morbidity without compromising survival, BCRL will     still remain a relevant problem in the future.      Objective: To improve breast cancer survivorship by reducing/eliminating one of the most     debilitating upper-body morbidities related to breast cancer treatment: chronic lymphedema of     the arm.      Study design: A multicenter, randomized controlled trial (RCT) carried out in the Maastricht     University Medical Center, VieCuri Medical Center and Zuyderland Medical Center in the     Netherlands.      Study population: The study population includes all women over 18 years old who underwent     surgical treatment for early stage breast cancer with an SLNB or ALND, or who received     axillary radiotherapy, presenting with an early stage lymphedema of the arm (stage 1 and 2a     on the ISL classification for lymphedema).      Intervention: In this RCT patients are randomized over two arms: the first group will     continue standard of care conservative lymphedema therapy, while the second group will     undergo lymphaticovenous anastomoses (LVA) by a plastic surgeon.      Main study parameters/endpoints: The main study parameters are the difference in excess limb     volume (ELV) after one of both treatments, the effect of treatment on the quality of life and     the cost-effectiveness of both treatments.      Study-specific procedures: After randomization the follow-up moments will be at 3, 6, 9, 12,     18 and 24 months. A follow-up moment includes an interview and a medical examination. During     this examination, the upper limbs will be assessed for sensory, motor, strength and mobility     changes. Furthermore, the investigators will measure the volume of the treated and untreated     side using the water displacement method and circumference measurement. A lymphoscintigraphy     is made at inclusion, after 12 months and after 24 months. Lastly, the subjects will be asked     at certain time points to fill in five questionnaires: Lymph-ICF, EORTC QLQ-C30, EORTC     QLQ-BR23, EQ-5D-5L and the DASH questionnaire.   "
37865|NCT02790008|"     Aortic valve disease causes impaired let ventricular function (LVF) due to hypertrophy,     dilatation and diffuse myocardial fibrosis yet the prognostic effect of fibrosis, waiting     time for operation and postoperative exercise training is presently unknown.      The investigators aim to (1) determine the changes in LVF for patients on the waiting list;     (2) establish non-invasive diagnostics for diffuse myocardial fibrosis; (3) relate LVF to     fibrosis and physical capacity.      The unique design (echocardiography, cardiopulmonary exercise test, cardiac magnetic     resonance tomography and myocardial biopsy on the same patients) makes it possible to     establish relationship between results of histology and imaging; quantifying and qualifying     fibrosis in vivo, evaluate LVF vs. general cardiopulmonary function and optimize health care     prior to and after operation.   "
37866|NCT02789995|"     Severe critical illness is often complicated by Intensive Care Unit - Acquired Weakness     (ICU-AW), which is associated with increased in and post-ICU mortality, with delayed weaning     from mechanical ventilation and with long-term functional. Several mechanisms have been     incriminated in the pathophysiology of ICU-AW, but muscle regeneration has not been well     investigated in this context, even though its involvement is suggested by the protracted     functional consequences of ICU-AW. Recent data suggest that muscle regeneration could be     impaired after sepsis, and that Mesenchymal Stem Cells (MSCs) treatment could improve the     post-injury muscle recovery.   "
37867|NCT02789982|"     The purpose of this study is: (1) to examine the effectiveness of reconsolidation blockade as     a treatment for trauma-related disorders, (2) to evaluate the feasibility of implementing     this new treatment on a large scale in a short delay. This clinical trial as been set up in     response to the Paris attacks to increase treatment capacity of the AP-HP (Assistance     Publique des Hopitaux de Paris) hospital network.. Reconsolidation blockade will be compared     to treatment as usual (TAU), on symptoms reduction after 6 weeks of treatment. In order to     measure effectiveness and cost-effectiveness, socioeconomic measures, quality of life and     social functioning outcomes will be measured pre- and post-treatment as well as 3 and 12     months after study enrollment.   "
37878|NCT02789839|"     Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species     or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including     kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in     quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce     DNA damage that may lead to the destruction of the cell.      The level of ROS in cells is the result of production (mainly the NADPHoxydase and the     mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology     team of the university hospital of Tours (France) found that certain antioxidant enzymes are     essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3     (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological     diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).      Age potentially affects the level of expression of antioxidant genes, since it was     established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J     Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of     age on the oxidative metabolism of normal hematopoietic cells, and in particular the     expression of antioxidant genes. It will provide a reference for analyzing disturbances of     oxidative metabolism in blood diseases. The main objective is the comparison of peripheral     blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59     years and 60-85 years. The level of ROS and the expression of genes encoding the major     antioxidant enzymes involved in the regulation of oxidative stress will be studied. The     secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a     cDNA library (blood and marrow) from healthy volunteers.   "
37868|NCT02789969|"     Every year over 1,000 children undergo eye muscle surgery provided by physicians at this     institution. For many of these children this is not and will not be the only surgical     procedure for eye muscle correction. All of these children will experience differing degrees     of postoperative pain. The pain associated with strabismus surgery is due to the manipulation     in the conjunctival area and further handling of Tenon's capsule, sclera and the stretching     of the eye muscle . Research has demonstrated that repeated painful procedures result in     increased anxiety and increased pain.      Previous studies have demonstrated that children experiencing preoperative anxiety are more     likely to have increased postoperative pain . This increased preoperative anxiety may also     contribute to sleep difficulties and increased analgesic consumption. Depending on the age of     the child, different methods are used to reduce anxiety such as distraction, child life     services, or anti-anxiolytic agents.      In addition to pain, children undergoing strabismus surgery frequently experience     postoperative nausea and vomiting (PONV).This increased incidence of nausea and vomiting is     thought to be related to the use of opiates for pain control. Short acting opiates are used     preferentially at this hospital in the belief that this reduces recovery issues of sedation     and PONV. Preliminary data, however, suggests no difference in recovery outcomes for fentanyl     versus hydromorphone. The purpose of this study is to investigate the optimal analgesia to     create a standardized approach for pain management in pediatric patients undergoing surgery     for strabismus.   "
38199|NCT02785653|"     This study evaluates the potentiation of muscle relaxation caused by rocuronium by     inhalational agent sevoflurane. Half the patients will be ventilated with oxygen ,nitrous     oxide and sevoflurane during induction of anaesthesia and half will be ventilated only with     oxygen and nitrous oxide.   "
38200|NCT02785640|"     This dual-arm randomised study aims to test a multi-component intervention to reduce     sedentary behaviour in a cohort of desk-based office workers.   "
37869|NCT02789956|"     The aim of this study is to evaluate:      Primary objective The primary objective of the present study is to evaluate the marginal bone     level changes when partially edentulous patients, treated with implants, received a     multiunits screw retained fixed dental prosthesis with a Co/Cr milled framework with an     Internal or External connection.      Secondary objective        1. Overall survival rate.        2. Soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth          (PPD) at baseline and after 1,3,5 years.        3. Prosthetic survival rates including screw or abutment loosening, framework or veneer          fractures.   "
37870|NCT02789943|"     Integrated and cross-disciplinary analysis of human physiology and disease provides unbiased     and deeply informative insights into human health and disease. In this study the     investigators will recruit patients undergoing coronary artery bypass surgery to study the     atrium of the heart or the aortic wall that when diseased can cause strokes.      Hypothesis: Systems-level analysis of the left atrium and aorta cells that integrates     imaging, histological, cellular and molecular data will identify new mechanism for     cardiovascular form and function.   "
37871|NCT02789930|"     The purpose of this prospective single center study is to investigate if a developed program     is more accurate than the anesthesia tape (Anästhesie-Lineal). For this study 1000 patients     are required to collect anonymized data (length, weight, age, anesthesia material used during     anesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist     that the program has a better accuracy than the anesthesia tape (Anästhesie-Lineal).   "
37872|NCT02789917|"     It is hypothesised that a dual therapy strategy by oral anticoagulation with the new     Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with     phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding     bleeding events in patients with atrial fibrillation undergoing percutaneous coronary     intervention in the setting of an acute coronary syndrome.   "
37873|NCT02789904|"     Current standard of care algorithm using high sensitivity troponin T (hsTnT) requires up to     6.5 hours to diagnose an ACS. Data will be stratified based upon time of symptom onset and     gender. A health economics and outcome model will be applied using the optimal high     sensitivity troponin I (hsTnI) cut-off values and draw times to determine the cost and     outcome benefits predicted from optimal utilization of hsTnI.      A chest pain registry will be set up to compare high sensitivity troponin I (hsTnI) versus     high sensitivity troponin T (hsTnT) for all patients who present to the emergency department     and require a blood draw. The outcomes of these patients will be tracked over the study     period.      The purpose of conducting this study evaluation is:        1. To shorten the chest pain protocol for suitable patients to < 3 hours compared to the          current 6 hours protocol with the latest high sensitivity Troponin I assays.        2. To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI+3          with an accelerated algorithm in comparison to the standard of care acute coronary          syndrome (ACS) algorithm and high sensitivity troponin T (hsTnT) assay, to rule-out or          rule-in for an ACS within 3 hours of presentation to the emergency room (ER) with          isolated suspected ACS.        3. To establish the local reference norms for hsTnI assays.   "
37874|NCT02789891|"     The purpose of this study is to explore the short-term, long-term and oncological outcomes of     laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.   "
37875|NCT02789878|"     This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen     deprivation therapy with goserelin and abiraterone with or without apalutamide prior to     radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.   "
37876|NCT02789865|"     Endoscopic retrograde appendicitis therapy (ERAT) is a new and minimally invasive method for     the diagnosis and treatment of acute appendicitis.After a positive diagnosis of acute     appendicitis is established by either colonoscopic direct-vision imaging or fluoroscopic     endoscopic retrograde appendicography (ERA) imaging in patients with suspected acute     appendicitis, the procedures to relieve the appendiceal lumen obstruction including     appendiceal luminal irrigation, appendicolith removal, and stenting for drainage whenever     necessary will be carried out. In this multicenter prospective randomized clinical trial, the     patients with uncomplicated acute appendicitis will be divided into three groups randomly:     ERAT group, antibiotic therapy group and appendectomy group. The primary outcome is duration     of abdominal pain. The secondary outcomes include mean hospital stay, mean operative time,     duration of fever, duration of leukocytosis, bed time, rate of complication, rate of     recurrence and rate of appendectomy during follow-up period of 1 year.   "
37877|NCT02789852|"     Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the     dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.   "
37915|NCT02789358|"     This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary     vein ablation procedures in patients with paroxysmal atrial fibrillation.   "
37879|NCT02789826|"     The aim of surgical procedures for resection of cancer stomach is to resection of the tumor     mass with safety margin and its drainage lymph nodes (lymphadenectomy).      There are two main types of techniques (open & laparoscopic) Many studies were done comparing     these two techniques showed that Laparoscopic resection is superior in early postoperative     recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open     resection (less safety margin & less lymphadenectomy) but because of the ongoing advances on     laparoscopic surgery these results needs more and more revision.      So the investigators conduct this randomized controlled trial aiming at comparing open and     laparoscopic resection of cancer stomach to choose the best surgical procedure for resection     of cancer stomach.   "
37880|NCT02789813|"     The purpose of this study is to evaluate whether valproic acid in combination with fear     memory reactivation is useful to enhance treatment stability of exposure therapy for specific     phobia.   "
37988|NCT02788409|"     This study is conducted to estimate population-based incidence rates of second primary     malignancies among patients with CRPC similar to those treated with Xofigo. These rates will     provide context for second primary malignancy incidence rates from the REASSURE study.      Furthermore this study aims to provide further information about the documentation of bone     metastases in Medicare data and the extent of use of only oral androgen deprivation drugs     among patients with Medicare Part D coverage, as well as to estimate overall survival of the     study population.   "
37881|NCT02789800|"     The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is     to reorient the health care system from a single disease focus to a multimorbidity focus;     centre on not only disease but also the patient in context; and realign the health care     system from separate silos to coordinated collaborations in care. PACE in MM will propose     multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be     grounded in current realities (i.e. Chronic Care Models including Self-Management Programs),     that are linked to Primary Care (PC) reform efforts. The study will build on this firm     foundation, will design and test promising innovations and will achieve transformation by     creating structures to sustain relationships among researchers, decision-makers,     practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is     mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces:     British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to     identify factors responsible for success or failure of current CDPM programs linked to the PC     reform, by conducting a realist synthesis of their quantitative and qualitative evaluations;     2) to transform consenting CDPM programs identified in Objective 1, by aligning them to     promising interventions on patient-centred care for multimorbidity patients, and to test     these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3)     to foster the scaling-up of innovations informed by Objective 1 and tested/proven in     Objective 2, and to conduct research on different approaches to scaling-up. This registration     for Clinical Trials only pertains to Objective 2 of the study.   "
37882|NCT02789787|"     Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or     underbites following early cleft repair surgeries. This clinical trial compares the current     standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after     pubertal growth (16-21 years), with an alternative orthopedic approach to protract the     maxilla during adolescence (11-14 years). At Children's Hospital Los Angeles(CHLA), early     adolescents with cleft lip and palate and Cl III malocclusion are offered an alternative     non-surgical approach to correct the malocclusion called maxillary protraction. Prior to     age 14, the maxillary sutures have not fused and can be mobilized by alternating weekly     expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper     jaw (maxilla) to be pulled forward (protracted) to correct the underbite. This prospective     parallel cohort study will assess the patients undergoing treatment for the Cl III     malocclusion by either orthognathic surgery or maxillary protraction at four data collection     time points during treatment. The data includes digitized study models, photographs and     radiographs, quality of life surveys (SF12, YQOL), parent surveys (ASEBA), treatment cost,     periodontal measurements and treatment complications. The study design is a descriptive     cohort study that examines the success of treatment (% not requiring a second surgery), the     dental and skeletal changes associated with treatment, the stability of treatment and the     behavioural/adaptive factors (ASEBA) that contribute to success and lack of success for each     treatment. The primary trial will be conducted at Children's Hospital Los Angeles and a pilot     study to confirm translation to different settings will be conducted at Seattle Children's     Hospital.   "
37883|NCT02789774|"     A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and     Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a     rigid collar. Follow up will be performed up to one year after start of treatment registering     EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct     and indirect costs of treatment will be registered and used for cost-effectiveness analysis.   "
37884|NCT02789761|"     A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33     healthy males to investigate the vascular and cognitive effects of bi-daily consumption of     high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects     visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning,     end and post-intervention.   "
37885|NCT02789748|"     This study aims at quantifying the performance of kinesthetic stimulation to reduce the     burden of obstructive sleep apneas and hypopneas.   "
37886|NCT02789735|"     Persistent pregnancy-related pelvic girdle pain is common, 2-5% av all women given birth is     suffering from disabling daily pain with high impact on quality of life.      A prospective double-blinded randomised controlled trial will be performed with a baseline     assessment 7-10 months after childbirth with follow-up directly and 6 months after a     treatment period with low level laser therapy (LLLT) or sham laser treatment, given at 12     planned treatment sessions during four weeks. 60 women will be included in the study.      If LLLT can reduce pain and improve function there will be a new treatment option for this     condition.   "
37916|NCT02789345|"     The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in     combination with osimertinib in participants with non-small cell lung cancer (NSCLC).   "
37961|NCT02788760|"     Most fractures of the cervical spine are considered stable and treated with a rigid cervical     collar. However no studies have to date been published addressing the length of treatment.     There seems to be a significant dissimilarity between hospitals within and between countries     with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical     department at Oslo University Hospital, Ullevål the standard length of treatment for a stable     cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar     treatment for a specific subtype of stable fractures in the cervical spine is sufficient.   "
37895|NCT02789618|"     Subjects with at least two teeth with dentinal hypersensitivity and who meet the study     criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical     trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash     out period). Baseline dentine hypersensitivity assessments will be conducted using tactile     stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the     Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted     using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP)     questionnaire will be completed at four defined time points during the study. The baseline     assessments will be conducted on the two teeth identified during the screening visit.      On completion of the baseline assessments, subjects will be randomly assigned to product.     Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product     use.   "
37887|NCT02789722|"     Mate or yerba-mate (Ilex paraguariensis A.St.-Hil.) is a native plant from South America     highly consumed in this region. Different traditional products (mate, mate tea, chimarrao,     tereré) are obtained from the yerba-mate leaves and consumed as herbal tea. Mate is a rich     source of bioactive phenolic compounds, mainly caffeoylquinic acids. The richness of     different mono- and dicaffeoylquinic acids is a peculiarity of mate derived products.     However, in contrast to other plant-based beverages rich in polyphenols like tea or coffee,     the research and the industry have yet little explored the potential interest of mate product     to promote human health. There has been a growing interest to the development of healthier     foods to face the burden of cardiovascular diseases (CVD), especially those naturally rich in     bioactive phenolic compounds with protective effects against the development of chronic     diseases. Different in vitro and animals studies associate the mate consumption with     cardiovascular protection mechanisms. Consistent information about this activity and the     long-term consumption effects in humans are scarce. The aim of this study is to assess     through a randomized controlled trial the impact of chronic intake of mate on intermediate     biomarkers of cardiovascular health in humans and to identify possible involved nutrigenomic     mechanisms.   "
37888|NCT02789709|"     Predictive biomarkers are needed to identify those patients with higher risk of recurrence     after surgery for colon cancer with curative intent. Our main objective is to determine a     metabolite profile in blood plasma from patients operated from colorectal cancer that can be     associated with the oncologic outcome and be validated as predictive biomarkers in future     studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell     lines treated with plasma samples from the same patients. In particular, to validate the     increased utilization of lactate by tumor cells as a metabolic substrate using postoperative     human samples.      Patients with colorectal cancer that have undergone surgical resection will be included.     Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and     18th months after surgery. Metabolic profiles in plasma samples will be determined using a     kit that allows the quantification of 180 metabolites by mass spectrometry.      A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.   "
37889|NCT02789696|"     Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that     comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with     acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly     gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the     association are based on maxillofacial modifications linked to acromegaly, a thickening of     soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated     obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative     muscles of the pharynx.      At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation     for sleep apnea syndrome.   "
37890|NCT02789683|"     The aim of this study is to compare the effects of emulsification and lipid droplet size on     gastric emptying rate, and to determine if the change in gastric emptying rate can in turn     influence postprandial glycemic, insulinemic and lipidemic responses.   "
37891|NCT02789670|"     New therapeutic approaches of MS are emerging, targeting different actors of the immune     system. Some of them target a specific population of white blood cells: B lymphocytes     composed of different subpopulations. The subsets of B cells express different functional     properties that control the immune response, but these regulation mechanisms have yet to be     clearly described. Some subpopulations could amplify inflammation through IL-6 production for     example, whereas some ones contribute to its regulation through the production of IL-10.     Using samples collected in a large cohort of individuals with risk of MS and treatment-naive     patients in the early onset of the disease, the investigators aim to develop a 2 year     follow-up study of the different blood B cells subset distribution and their functional     properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach     can identify new biomarkers for monitoring of MS patients and lead to better define the     indication use of depletive B cell drugs and not to counteract the regulatory action of these     cells.   "
37892|NCT02789657|"     Neoadjuvant therapy is given to breast cancer patients whose cancers are relatively large or     have spread to lymph nodes or both. The primary goal of this treatment is to prevent the     cancer from coming back (recurring) elsewhere in the body, but if it makes the cancer in the     breast and lymph nodes shrink it might be easier to remove. This could allow a patient to     have a lumpectomy instead of a mastectomy and reduce the number of lymph nodes that the     surgeon has to remove. In some cases, the neoadjuvant therapy works so well that it kills all     of the cancer in the breast and lymph nodes. This is referred to as a pathologic complete     response (pCR). Patients who achieve a pCR have a much lower risk of the cancer recurring     elsewhere in their bodies.      Investigators aren't sure which chemotherapy drugs work best with the HER2-targeted drugs,     and what combination of these drugs causes the fewest side effects.Thus, this study has two     main goals:        1. To find out if treatment with wPCbTP, weekly paclitaxel and carboplatin given with          trastuzumab and pertuzumab every 3 weeks, leads to as many pCRs as TCHP in patients with          HER2-positive breast cancer, but has fewer side effects.        2. To find out if HER2-positive patients whose cancers are not responding well after 12          weeks of wPCbTP get a better response when they are switched to a doxorubicin-containing          regimen called AC for 4 cycles (8-12 weeks).   "
37893|NCT02789644|"     A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy     elderly subject after ursodeoxycholic acid administration   "
37894|NCT02789631|"     Several factors have been associated with neck pain. Controversy exists regarding the degree     of association between some of these factors and neck pain. Information regarding the degree     of association of each factor to neck pain is needed for effective prevention and appropriate     treatment strategies. The aim of this study is to investigate the association among     musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic     nonspecific neck pain.   "
37962|NCT02788747|"     This is multi-center, randomized, double-blind, placebo-controlled study in patients with     stable heart failure with reduced ejection fraction (HFrEF) to evaluate the effects of     multiple subcutaneous injections of elamipretide on left ventricular function.   "
38231|NCT02785237|"     The objective of the study is to evaluate the process of early re-endothelialization of the     Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent   "
37896|NCT02789605|"     Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and     painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation     of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe     side effects or inconstant effectiveness. The aim of this study is to assess the     effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in the     treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects with     RAS. Treatment consisted on the administration of the daily probiotics or placebo during 3     months.All patients will be then followed up for additional 3months without treatment. The     main outcome measure will be the number of occurring aphtae.   "
37897|NCT02789592|"     The purpose of this study is to determine whether melatonin prolonged-release (PR) and     clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder     (RBD) of patients with Parkinson's disease (PD).   "
37898|NCT02789579|"     Minimally invasive upper tract lithotomy is currently a common operation method on treatment     of urinary tract stones, but the postoperative complication urinary tract infection or     urinary sepsis has turned into a serious threat to the patient's life, when severe, can     result in a higher death rate.Although more the more importance were attached to, an     effective prevention measures still have not been found.      Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of     postoperative urinary tract infection. The conventional postoperative prophylaxis medicine     was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that     continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence     of urinary sepsis. So the investigators assume that preoperative extended use time of     prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis.      This study uses a computerized random method. According to preoperative use of different     antimicrobial drug or treatment, all patients are randomly divided into three groups, namely     levofloxacin group, nitrofurantoin group and control group.The levofloxacin group receives     levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid,     po.to explore the better antibiotics types, medication timing and duration of treatment to     prevent postoperative infection after minimally invasive upper tract lithotomy, so as to     reduce the incidence of postoperative urinary tract infection or sepsis.   "
37899|NCT02789566|"     The primary objective of this study is to provide a description of the pharmacokinetic     properties of primaquine and metabolites and characterize these in healthy obese Thai     subjects.      This is an open-label, single dose pharmacokinetic study in 10 healthy obese G6PD normal,     subjects will be admitted as inpatient to receive 1 regimen for 1 visit only.   "
37900|NCT02789553|"     Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has     been associated with the onset of hyperglycemic peaks, which are very intensive and     transient, in formally non diabetic patients. The aim of this study is to study the digestion     of starch as compared to that of glucose (same glucose load) before and after gastric bypass     surgery in obese patients.      Volunteers will be recruited among the candidates to a gastric bypass, and will be studied     before and 3 months after surgery. They will have on each occasion 2 random meals,     corresponding to 30g glucose, one made of starch the other made of glucose, both naturally     labeled with 13C. The digestion of starch will be assessed with the increase in the plasma     13C-glucose tracer. Plasma samples will be collected for 3 hours.      Some studies have already investigated time of absorption of glucose, but any study has     examined the time of digestion of glucose. Other study always used glucose syrup, so they     cannot have results about digestion. It is the reason why, in this study, glucose syrup and a     starch meal will be taken by the same patient and glycaemia will be compared. In this way,     results will be obtained about the kinetic of digestion of starch.   "
37901|NCT02789540|"     This is a multi-country, multicentre, observational prospective data collection cross     sectional study of patients with stable COPD in Latin America. Primary objective is to assess     and characterize COPD symptoms over a period of 24 hours, by collecting information about the     respiratory symptoms experienced at different times of the day and night-time in patients     with stable COPD under real clinical practice conditions. Correlation between each of these     symptoms and the Global Initiative for Chronic Obstructive Lung Disease (GOLD)     classification, adherence to respiratory treatment, level of dyspnea, disease severity,     comorbidities and physical activity as well direct costs will be done as secondary     objectives. Study population are patients of 40 years and older, smokers or ex smokers of >=     10 pack/years with previous COPD diagnosis, attending outpatient specialists consults in     Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico. Sample size is     targeted to 900 enroled patients in order to ensure 860 patients to achieve statistical power     to primary objective.   "
37917|NCT02789332|"     This is a multicenter, prospective, randomized, open-label phase II study evaluating the     efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast     cancer in patients with HR deficiency. Patients will be randomized to receive        -  paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg (4X25mg) twice          daily for 12 weeks (65 patients) or        -  paclitaxel 80 mg/m² iv weekly in combination with carboplatin AUC 2 iv weekly for 12          weeks (37 patients) both followed by 4 cycles of epirubicin 90 mg/m² and          cyclophosphamide 600 mg/m² (EC) either every 3 or every 2 weeks followed by surgery.      The control arm was chosen to allow direct comparison with one of the currently considered     standard of care regimen.   "
37964|NCT02788721|"     The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study     evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses     of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate     safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451     given to healthy female subjects compared to placebo as well as of multiple doses of the     combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.   "
37989|NCT02788396|"     This study aims to assess the impact of NC balloon post-dilatation on coronary     microcirculation in patients with ST segment elevation myocardial infarction (STEMI)     undergoing primary percutaneous coronary intervention (PPCI).   "
37990|NCT02788383|"     Actually, our center is doing the prenatal determination of RhD fetal genotype in all RhD     negative pregnant women.      The investigator want to demonstrate that this is an useful and efficient method.   "
37902|NCT02789527|"     Physicians know that their patients can react differently to the same medical treatment: for     some of them, the drug will prove inefficient, whereas for others it might provoke     side-effects, sometimes rather serious. Such differences in response to drug intake are due     to several factors, of which molecular variations in specific genes, named  ADME      (Absorption, Distribution, Metabolism, Excretion). This project aims at investigating the     evolutionary mechanisms responsible for the diversity of ADME genes in human populations.     Because of their role at the interface between the organism and its chemical environment,     ADME genes are likely targets of recent selective pressures linked to changes in the     environments in which humans evolved, such as changes in dietary habits for instance.      The aim of this project is to study the diversity of ADME genes and of their expression in     five populations located along a latitudinal axis that extends from East Africa to Central     Europe, passing through the Arabian Peninsula and the Mediterranean area, so as to take into     account environmental factors that might have influenced the evolution of this diversity.     This project is thus intended to evidence the evolutionary mechanisms that shaped genomic     regions that are functionally important from the clinical and epidemiological point of view.     Moreover, it will allow us to extend the knowledge of human molecular diversity and its     evolution to a key-region of the peopling history of our species.   "
37903|NCT02789514|"     Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology     diseases. The investigators want to find which symptoms can support for positive endoscopic     findings.   "
37904|NCT02789501|"     Catheter infections and dysfunctions are a major cause of morbidity and mortality in     haemodialysis patients. According to the US Renal Data System, infection is the second     leading cause of death in dialysis patients and the leading cause of catheter removal and     morbidity in patients with end-stage renal disease.      There is evidence that catheter lock solutions containing taurolidine reduce the risk of     catheter related infections and improve catheter patency. Lock solutions have a local, but no     systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500,     Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm,     Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL,     Montreal, Canada, 3x/week) as standard lock solution.      The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled     haemodialysis catheters has reducing effects on catheter related blood stream infections and     catheter dysfunctions.   "
37905|NCT02789488|"     Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive     age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels.     The genetically determined cause of the PCOS includes disturbed levels of insulin and     androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as saponins     & flavonoids which act on the insulin and indirectly helps to regulate the androgen levels in     the body.   "
37906|NCT02789475|"     An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of     amlodipine and rosuvastatin in healthy adult male subjects.   "
37907|NCT02789462|"     This is a multi-center, investigator initiated study that will prospectively and     retrospectively examine treatment strategies and outcomes of patients who underwent     percutaneous coronary interventions (PCI).      The goal of this multi-center, investigator initiated, registry is to collect information on     treatment strategies and outcomes of consecutive patients undergoing laser-assisted PCI among     various participating centers. The study is a purely observational, chart review study and     involves retrieval and compiling of data based on clinically indicated procedures and     follow-up clinical and procedural outcomes.      The information collected will be used to determine the frequency of laser-assisted PCI     performed at the participating sites and examine the procedural strategies utilized, and the     procedural (both immediate and subsequent) outcomes.   "
37908|NCT02789449|"     The aim of the study is to investigate the role of the non-invasive assessment of nitric     oxyde (NO) diffusion capacity (DLNO) in the differential diagnosis of different forms of     pulmonary hypertension (PH). DLNO alone and in combination with the measurement of carbon     monoxide (CO) diffusion capacity (DLCO) may help to differentiate between pre- and     postcapillary forms of pulmonary hypertension. This hypothesis is based on the fact that NO     has a much higher affinity to hemoglobin as compared to CO and may therefore its decrease may     more specifically identify the limiting factors between the alveolar space and the lung     capillaries including left heart failure (cardiac edema).      As there are no available published data yet to answer this question investigators aim to     perform a small pilot study. The results of this study may allow the planning of a     prospective study.   "
37909|NCT02789436|"     The purpose of this study is to determine whether Lactobacillus reuteri-containing lozenges     (Prodentis) are effective in treatment of halitosis in patients with chronic periodontitis.   "
37910|NCT02789423|"     The purpose of this study was clinical and radiographical evaluation of the effect of calcium     hydroxide cement (Dycal) and calcium silicate cement (Biodentine) in direct pulp capping in     primary teeth.   "
37911|NCT02789410|"     Intrathecal (IT) opioids are commonly administered with local anesthetic during spinal     anesthesia for post-Cesarean delivery analgesia. Traditionally, IT morphine has been used but     the use of IT hydromorphone is growing. A previous study has shown that the effective dose     for postoperative analgesia in 90% patients (ED90) for both IT hydromorphone and IT morphine     (NCT02009722). These doses were found to be 75 mcg for hydromorphone and 150 mcg for     morphine. The current proposed study would compare the duration of analgesia of IT morphine     vs IT hydromorphone after elective cesarean delivery. Additionally, the investigators will     compare each drug with respect the incidence of nausea and pruritus.   "
37912|NCT02789397|"     This phase II study will assess the effect of a treatment combination of Rituximab and     azathioprine in patients with Granulomatous and Lymphocytic Interstitial Lung Disease (GLILD)     compared to placebo, based on change in lung function at 18 months compared to baseline. The     researchers will also assess if the drugs improved quality of life.   "
37913|NCT02789384|"     This is a prospective observational biomarker study including patients with non-metastatic,     soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option     by the multidisciplinary sarcoma team of one of the participating centers.   "
37914|NCT02789371|"     The purpose of this study is to compare the diagnosis accuracy of modified wet suction     technique and 5ml dry suction technique on solid occupying lesions.   "
37918|NCT02789319|"     The blanket protocol covers the execution of the Diabetes Technology Society (DTS) Blood     Glucose Monitor System Surveillance Program that will consist of a series of similar accuracy     sub-studies with marketed Blood Glucose Monitor Systems (BGMS) conducted by the Clinical and     Laboratory site(s) chosen for this study. The two parts of the study (BGMS testing and     comparative glucose analyzer testing) will be conducted in separate facilities (clinical site     and laboratory site) so the clinical and laboratory investigators will be blinded from each     other's results.      To access the full protocol:     http://dst.sagepub.com/content/early/2015/12/10/1932296815614587.full.pdf+html      The clinical site(s) will recruit subjects and test their fingerstick blood directly on the     Blood Glucose Monitor Systems. Tubes of fingerstick blood will also be collected from the     same subjects, centrifuged and the plasma collected and frozen for shipment to a Clinical     Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) certified,     accredited clinical chemistry laboratory for measurement on a comparative glucose analyzer.     In addition, National Institute of Standards and Technology (NIST) glucose standards (965b)     will be assayed on the comparative glucose analyzers to determine any bias from the true     glucose values established by the reference mass spectrometry method.      This series of sub-studies will assess the accuracy of various BGMSs by trained     professionals, not by the intended end user. Only accuracy of the BGMSs when tests are     performed by trained study staff will be assessed. Understanding by the end user of     instructions for use (labeling) and human factors analysis are not within the scope of this     protocol.   "
37919|NCT02789306|"     In the field of periodontics, periodontal support therapy has proven to be essential in     preventing the incidence or recurrence of periodontal diseases. The protocol is designed     according to the risk profile of a patient. For example, in the presence of the history of     periodontal therapy, subgingival microbiota containing large numbers of spirochetes and     mobile rods can recolonize pockets 4-8 weeks after scaling. Similarly, routine maintenance of     dental implants has been recommended to prudently avoid peri-implant inflammation, Indeed,     the understanding of the nature of the tissue around the implant and its pattern of disease     would be important to consider, even surpassing importance. Recently, a systematic review by     our group has identified the importance of maintenance therapy around implants because it can     help prevent about 3 times patient-level frequency peri-implantitis.      Henceforth, our primary goal was to study the influence in a cross-sectional study of the     frequency of peri-implantitis patients according to their post-implant placement and     corresponding prosthesis visits supportive peri-implant maintenance. As such, it will be     shown:        1. What are the local and systemic factors affecting the appearance of peri-implantitis        2. The ideal frequency of supportive peri-implant maintenance in patients who do not          develop peri-implant disease        3. What is the population of patients who come to supportive peri-implant maintenance after          placement of dental implants   "
37920|NCT02789293|"     The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound     treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.   "
37921|NCT02789280|"     The main goal of this study was to compare the effect of a one-session unsupported Internet     intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related     variables (mood, confidence and motivation).   "
37922|NCT02789267|"     Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of     the patients at the time of the diagnosis. According to the recommendations of the French     Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five     percent loss of weight compared to the previous weight increases the risk of toxicity of the     chemotherapy and worsens the patient's quality of life.      The treatment of the tumors of the head and the neck comes along very often with a loss of     weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.) which     varies with the chosen treatment, and shows a major risk at the patients whose therapeutic     sequence involves a radiotherapy. The irradiation of the upper aerodigestive tract is source     of aftereffects and late complications: xerostomia, oedemas of mucous membranes.      The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of     the patients. It reveals or even increases, a dysphagia. According to Woisard, six months     after the end of treatments, forty percent of the patients suffer from a dysphagia.      All these complications limit quantitatively and qualitatively the food intake. The     adaptation of the texture of the food is necessary by fifty four percent at three months of     the end of treatments according to Logemann et al., and a few patients remain dependent on an     long term enteral nutrition.      Beyond a change of the nutritional state, the feeding difficulties or even the absence of     resumption of an oral feeding are responsible for a social isolation. The meal which lost its     dimension of pleasure becomes a source of fear and obsession for the patient as well as for     his relations, and this fact generates family tensions. The quality of life of the patient is     heavily affected.      Ravasco showed in his study that the impact on the nutritional state of a nutritional care by     dietary advices was more important as the prescription of oral nutritional supplements but     based on a short period (the dietary intervention covered only the duration of the     radiotherapy). But what would happen after the end of treatments? The investigators emit the     hypothesis that a post-therapeutic systematic and regular dietary support has a positive     impact on the prevention of the undernutrition among the patients affected by a first cancer     of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.   "
37923|NCT02789254|"     This is a first in human, prospective, monocentric, nonrandomized, open-label study to     investigate the safety, tolerability, preliminary efficacy, pharmacokinetics,     pharmacodynamics and immunogenicity of the Fc-optimized antibody FLYSYN as monotherapy in     adult subjects.   "
37924|NCT02789241|"     The purpose of this study is to evaluate 4-dose levels of CCRE Lot 94332B1 (0.6, 1.0, 2.0,     and 4.0 ng/kg). This study is known as, an endotoxin challenge. Thousands of healthy     subjects worldwide over the last 20 years have participated in endotoxin challenge studies as     part of clinical research and clinical drug development programs. This study will only test     the safety and tolerability of CCRE Lot 94332B1.   "
37925|NCT02789228|"     Patients with high-risk solid tumors, those that are refractory to standard up front therapy     or relapse after completion of therapy, have a very poor prognosis despite attempts to induce     remission with salvage regimen. Novel therapies are critical for this patient population with     high-risk cancer.      The ability of tumors to be recognized and lysed by the immune system offers a unique     opportunity to aid in tumor eradication by expanding and activating these anti-tumor cells.     Through this ability to harness sophisticated and specific immunotherapy, residual or     relapsed disease that is resistant to chemotherapy and/or radiotherapy could be eradicated.     Prior studies have suggested both safety of expanded specific T cells and efficacy in the     setting of melanoma, lymphoma or viral eradication. While this therapy has previously been     limited by the versatility of the tumor to down-regulate antigens and evade a single     immune-target, the use of multi-antigen specific T cells may permit better and more durable     anti-tumor immunity. Thus, the investigators propose to infuse these specific multi-antigen     anti-tumor T lymphocytes into patients with high risk solid tumors. This trial will be     conducted to demonstrate safety of these cells and generate efficacy and biology data that     may be important for future studies that may enhance tumor immunotherapy.   "
37926|NCT02789215|"     Child and Adult Care Food Program (CACFP) meals are an important influence on diets of     children from low-income families enrolled in the CACFP and should meet children's nutrient     needs while fostering healthy eating habits that enable them to maintain energy balance.     Recent national data revealed that children consumed low intakes of foods that support     healthy dietary patterns (whole grains, fruit and vegetables other than potatoes), but high     intakes of low nutrient, energy dense foods. The 2011 USDA-commissioned Institute of Medicine     (IOM) report for CACFP meals provided new recommendations that include new meal pattern     requirements for the meals programs, aligning them with the U.S. Dietary Guidelines to ensure     that the meals promote health and reduce inadequate and excessive intakes. The report     recommended inclusion of more whole grains, fruit, vegetables, and meat/meat alternatives     which will likely increase meal costs. Two of the IOM report recommendations call for     research to better understand how the new meal requirements would change children's CACFP     meal dietary intakes and food service costs. These are important questions, and answers are     needed to inform policy and future technical and educational assistance needs. The overall     objective of this project is to implement the IOM meal pattern requirements for CACFP meals     in day homes and centers in Texas. The multidisciplinary team will focus on nutrition,     economics, and provider outcomes. The specific aims are to assess the impact of the new meal     pattern requirements on 1) Meal participation rates; 2) Provider food service costs (food,     labor, total meals); and 3) Child dietary intake at CACFP homes and centers. It is     hypothesized that, compared with control sites, intervention site children will select and     consume healthier diets (more fruit, vegetables and whole grains) at school. A total of 32     day care sites will be recruited for the study. It is hypothesized that, compared with     control sites, children at the intervention sites will select and consume healthier diets     (more fruit, vegetable and whole grains) at the center. It is also hypothesized that the     increase in food costs will be less than that projected in the IOM report. The results on the     costs associated with creating the desired meals will be very important as these data have     not been systematically collected in previous studies. This significant study targets     underserved minority populations with health promoting intervention to reduce health     disparities, and in addition, will inform policy on the influence of a healthy food     environment on children's diet, as well as provide critical information on costs.   "
37927|NCT02789202|"     This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in     arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides,     the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this,     100 babies 1-3 years will be examined and treated in a mobile dental unit, which will     temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis     will be conducted using the International Caries Detection and Assessment System (ICDAS).     Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and     Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6,     12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered.     Acceptability reported by parents after treatments, the time and estimated money spent for     treating will also be collected. Social and biological data that could be related to efficacy     of techniques will be also collected. Multilevel analyses will be performed to check which     technique will be most effective and possible factors associated to its efficacy. Discomfort,     acceptability and costs will be compared between/among the approaches used to arrest enamel     caries lesions.   "
37928|NCT02789189|"     The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy     of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic     nasopharyngeal carcinoma   "
37929|NCT02789176|"     The purpose of this study is to examine whether the duration of treatment with phenobarbital     has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family     well-being, after neonatal seizures.   "
37930|NCT02789163|"     Women age >18 scheduled for a diagnostic ultrasound examination had both a hand held     ultrasound and an automated breast volume scan. Exams were performed by different     technologists. Images were blinded and blinded read for diagnostic accuracy of the two     examinations   "
37931|NCT02789150|"     Comparing renal outcomes based on a Mean Arterail Pressure (MAP) of 65-7085mmhg versus a MAP     of greater than or equal to 85mmhg   "
37932|NCT02789137|"     The purpose of this study is to know about the quality of life of patients with metastatic     renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who     suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore     measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or     cure such side effects that affect patients.   "
37933|NCT02789124|"     Difficulties in the accurate assessment of intravascular volume in critically ill patients     are frequently encountered. In addition to clinical evaluation, bedside echocardiographic     measurements of fluid responsiveness can be technically difficult, especially in critically     ill mechanically ventilated patients. The carotid artery is an easily accessible structure     that is amenable to bedside ultrasonography performed by Intensivists. The investigators     hypothesize that measurement of the carotid artery Corrected Flow Time (FTC) in response to a     passive leg raise (PLR), which simulates a fluid bolus, can be used to predict fluid     responsiveness.   "
37934|NCT02789111|"     The Investigator has chosen to study the reconstructive spinal surgery patient population     because it is believed that the use of alvimopan in these patients at the University of     Virginia will give the scientific community significant insight into the broader     applicability of this drug into other surgical populations, the impact of this drug on the     perception of pain (as opposed to simply the consumption of opioids), and its impact on total     hospital charges, resource utilization, and functional outcomes.   "
37935|NCT02789098|"     Left ventricular remodeling is a common complication in patients with ST-elevation myocardial     infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory     mechanisms are involved in this pathophysiological process. Recent data demonstrated that     remote, noninfarct-related region of the myocardium is also implicated. There is no data     about the assessment of coronary endothelial function or myocardial fibrosis in the remote     zone in patients with STEMI . The correlation between these parameters and left ventricular     remodeling is not known.   "
37950|NCT02788903|"     The overarching goal of this proposal is to understand the comparative effectiveness of     obesity counseling as covered by CMS in improving weight loss for adults either with or at     high risk of type 2 diabetes. CMS and most insurers now include obesity screening and     counseling benefits, with no cost sharing to patients. Since overweight patients are at     highest risk for diabetes, improved weight management services could prevent diabetes and its     negative health outcomes. Beneficiaries with obesity are eligible for up to 20 face-to-face     visits for weight counseling in the primary care setting. We propose comparing weight and     diabetes outcomes in three states using EHR and claims data before and after this policy was     implemented by leveraging the novel infrastructure of the Patient-Centered Outcomes Research     Institute-funded PaTH Clinical Data Research Network.   "
49502|NCT02637687|"     This is a multicenter, open label, Phase 1/2 study in pediatric patients with advanced solid     or primary CNS tumors. LOXO‑101 (larotrectinib) will be administered orally (PO) twice daily     (BID), with the dose adjusted by body surface area (BSA).   "
37936|NCT02789085|"     Using computerized pupillometry, previous research established that the autonomic nervous     system (ANS) is dysregulated in patients who suffer from temporomandibular disorders (TMDs),     suggesting a potential role for ANS dysfunction in pain modulation and the etiology of TMD.     However, pain modulation hypotheses in TMD are still lacking.      The periaqueductal gray (PAG) is involved in the descending modulation of defensive behavior     and pain through μ, κ, and δ opioid receptors. Transcutaneous electric nerve stimulation     (TENS) has been extensively used for pain relief, as low-frequency stimulation is able to     activate µ receptors. The aim of the present study is to use ANS polygraph and salivary/serum     biomarkers to evaluate the effect of low-frequency TENS stimulation of ANS in TMD patients.      According to the Research Diagnostic Criteria for TMD, people with myogenous TMD and     matched-controls will be enrolled. All subjects will be randomly assigned to control group     (no tens stimulation) and case group (test stimulation); subsequently, ANS parameters by both     biomarkers and ANS polygraph, before, soon after (end of stimulation), and late after     (recovery period) sensorial TENS will be collected.      The overall statistics will be performed from all conditions recorded comparing controls vs     cases.      The expected results consist in discovering ANS deregulation in TMD with and without TENS     stimulation.   "
37937|NCT02789072|"     Cardiovascular events remain the main cause of death of the industrialized world (Global     status report on noncommunicable diseases 2010. Geneva, World Health Organization, 2011).     Arterial hypertension, hyperlipoproteinemia, smoking, diabetes and family history represent     the main cardiovascular risk factors. Arteriosclerosis leads to coronary heart disease,     cerebrovascular insufficiency and peripheral vascular diseases that reflect in myocardial     infarction and stroke.      The main objective of this experiment is to investigate the differential effect of     microgravity on central aortic blood pressure.      The main criterion is the central aortic pressure (measured in mmHg). The hypothesis is that     microgravity leads to an increased central aortic pressure.   "
37938|NCT02789059|"     Previous studies showed modifications of muscle oxygenation parameters in muscular     dystrophies du to an impairment or an absence of dystrophin.      Our study aim at assessing muscle oxygenation during effort in different neuromuscular     diseases (muscular dystrophies related and not related to dystrophin, non dystrophic     myopathies and motor neuron diseases) compared to a group of healthy controls. Patients and     controls are invited to perform an inframaximal , standardized effort of the knee extensors     by the mean of an isokinetic dynamometer. Muscle oxygenation parameters are assessed through     a Near Infrared Spectroscopy (NIRS) Device.      In patients affected by dystrophin related myopathies, a muscle biopsy will be performed in     order to analyse mitochondrial oxygenation parameters and mitochondrial phenotype.      Our Hypothesis is that muscle oxygenation is impaired in dystrophin related muscular     dystrophies compared to other neuromuscular diseases and healthy controls because of lack of     muscle capillary vessels dilatation during effort and impairment of mitochondrial function.   "
37939|NCT02789046|"     The objective of the prospective multicenter observational study consists in defining a     difficult intravenous access score in adult, during the preoperative period.      The main objective: the outcome of interest is defined as failure of cannulation on first     attempt.      The risk factors of failure of cannulation on first attempt will be described. Adjusted     multivariate models will be constructed. A prediction model will be proposed according to the     transparent reporting of a multivariable prediction model for individual prognosis or     diagnosis (TRIPOD)   "
37940|NCT02789033|"     The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition     is more frequent in elder patients. It is estimated that about 5% of all patients with     diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients     developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while     10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation     within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb     amputation could also be involved in a new amputation in the next year; higher or in the     other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are     preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests     multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading     device, wound care and surgery in selected cases. However, treatment of DFU remains     challenging because of unsatisfactory results from surgical and non-surgical treatments. Many     adjunctive therapies are designed to improve the care of DFU including negative pressure     wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB)     Hyperbaric oxygen and acellular matrix product among others.   "
37941|NCT02789020|"     Parkinson's disease (PD) is a neurodegenerative brain disorder that impairs the ability to     perform functions such as grooming, dressing, cooking, and other activities of daily living.     PD affected between 4.1 and 4.6 million people worldwide in 2005, and it is projected that up     to 9.3 million people will be affected by 2030. Although current pharmacological therapies     provide beneficial effects on motor symptoms of the disease (tremor, rigidity, and     bradykinesia), intolerable disability eventually develops in most patients. A     disease-modifying therapy that slows disease progression is a major unmet medical need in PD.     Numerous agents have neuroprotective effects in pre-clinical laboratory models, but none have     been shown to have indisputable disease-modifying effects in clinical trials for patients     with PD.      The purpose of this research study is to investigate how the brain and motor behavior changes     in PD over time in response to rasagiline which is a monoamine oxidase-B(MAO-B) inhibitor.     The drug rasagiline will be tested in this study as the MAO-B inhibitor. Rasagiline has been     prescribed for many years to treat symptomatic Parkinson's disease. It is FDA approved for     the treatment of Parkinson's disease but has not been shown to slow disease progression. The     outcome and impact of this study will provide the first evaluation of MAO-B inhibitors at     slowing the progression of the nigrostriatal pathway using advanced Magnetic Resonance     Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) methods in PD.   "
37951|NCT02788890|"     The study will evaluate the vital signs changes during 3 different dental procedures     performed for the same patient by the same dentist. The patients will be selected randomly     and should all be healthy adults.      The aim is to look for any significant changes in the major vital signs (heart rate,     respiratory rate, blood pressure, peripheral capillary oxygen saturation (SpO2) and body     temperature) during specified dental procedures (scaling, simple restoration, and simple     exodontia) and compare the changes between the 3 procedures.   "
37942|NCT02789007|"     The main objective of this experiment is to assess the impact of parabolic flight on (1)     spatial memory and orientation, (2) the changes in brain structure and function, and     particularly the hippocampal formation, and (3) biochemical markers of stress and     neuroplasticity.      A preliminary study will be performed with the aims (1) to test during weightlessness     hardware used to administer visuo-spatial testing and (2) to determine the optimal body     posture for testing under microgravity conditions (i.e. body posture for which change in     visuo-spatial testing induced by weightlessness is maximal).      The main criteria are:        -  Structural and functional changes of brain evaluated by fMRI;        -  Cognitive performance, and specifically spatial cognition using a series computer-based          tasks.        -  Key neurotrophins determined in venous blood samples The criteria used in the          preliminary experiment is visuo-spatial performance evaluated with a computer-based test          assessing spatial cognition.      The investigators hypothesize that hippocampal structure and function, and particularly the     dentate gyrus, will be altered after parabolic flight compared to ground based controls.     Specifically, the 3 tested hypotheses are:        -  Parabolic flight induces changes in hippocampal structure;        -  Weightlessness induces changes in cognitive performance, and specifically spatial          cognition;        -  There is a correlation between changes in hippocampal structure and changes in          visuo-spatial memory performance.        -  There is a correlation between changes in hippocampal structure and changes in key          neurotrophins.      The hypothesis tested during the preliminary experiment is that body posture affects the     changes in spatial cognition performance.   "
37943|NCT02788994|"     This is a preliminary study to establish the issues and potential of the investigators     proposed project, which involves recruitment of patients with and without dementia, who have     been admitted to hospital following hip fractures. The study will be evaluating the result of     treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is restored     leading to their independence. These patients would require surgical fixation (not     replacement) of their hip fractures.      The study will evaluate two methods of fixation of hip fractures treated with either a pin     (nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate     which is applied on the outer aspect of the thigh bone.      The data collected from this study will provide information on whether one method of fixation     is better than the other.   "
37944|NCT02788981|"     This is a randomized, placebo-controlled, double-blind, phase II trial of nab-paclitaxel with     or without mifepristone for advanced, glucocorticoid receptor-positive, triple-negative     breast cancer. A total of 64 patients will receive nab-paclitaxel. Patients will be randomly     assigned to either receive placebo or to receive mifepristone daily on the day prior to and     day of each dose of nab-paclitaxel. Patients will be enrolled over 12 months and followed for     12 months following completion of study.      To expand and follow up on the investigators understanding of a potential PK interaction     between nab-paclitaxel and mifepristone, investigators will perform PK studies in the first     20 patients enrolled at pre-specified PK sites.   "
37945|NCT02788968|"     The study to explore the development of these abilities with age, and called Development of     the conflict detection during the reasoning - Decor will take place at CYCERON center and     will include two groups of 22 participants: adolescents and young adults (N = 44). More     specifically, this study aims to compare the changes in the brain of adolescents and young     adults when conducting reasoning tasks for which there may be a cognitive conflict. Both     groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain     and in which they will carry out two classic tasks covering the main areas of reasoning     (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of     making information call intuition to create or not a conflict between the correct answer     (logic, normative) and biased response (intuitive, heuristic). Because of the major     implication of this brain region in cognitive inhibition processes [of intuitive answer],     measured brain activity in the anterior cingulate cortex (ACC) during both tasks version     with or no conflict will be compared between groups. To better understand the links     between the development of the CCA from adolescence to adulthood and conflict detection,     activity measurements will be correlated with a part in morphometric measurements taken from     the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly     to cognitive measures (executive functions - inhibitory control). This cross-sectional study     focused on two age groups: 11-15 years and 19-25 years. For each age group, the participation     of men / boys and women / girls will be balanced up.   "
37946|NCT02788955|"     This is a feasibility study to test the efficacy of diets of different amounts of protein and     calories for patients with cancer. We hypothesize that nutritional deficits play a     significant role in muscle loss and that nutritional therapy is an important first step in     reversing or preventing muscle loss and maintaining/improving physical function, tolerance to     treatment and quality of life.   "
37947|NCT02788942|"     Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators     are investigating the effect of the removing of cholecystectomy material from different     ports, to the port site infections.   "
37948|NCT02788929|"     Design: Single center, prospective, randomized study that will compare activity levels in     patients who complete cardiac rehabilitation after clinically indicated percutaneous coronary     intervention with and without use of the wrist-worn Fitbit Charge HR device and mobile     platform application.      Primary Endpoint: The average number of steps taken per day will serve as the main marker of     daily physical activity.      Control: Patients who do not receive the device (Fitbit Charge HR).      Secondary Endpoints: (1) change in daily energy expenditure (2) change in number of activity     and sedentary bouts (3) change in sleep efficiency (4) change in weekly time of     moderate/vigorous physical activity (5) change in quality of life (6) change in indicators of     depression (7) change in medication adherence(8) change in HDL and LDL cholesterol (9) change     in BMI and waist circumference (10) change in resting heart rate and blood pressure (11)     change in exercise stress test performance (timeframe for all: baseline - 12 weeks)   "
37949|NCT02788916|"     The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte     (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World     Health Organization (WHO) classification of lymphoid neoplasms.   "
37952|NCT02788877|"     Efficacy of Treat-and-extend regimen (TER) using aflibercept in diabetic macular edema (DME)     will be evaluated.   "
37955|NCT02788838|"     The purpose of this project is to examine the impact that television food advertisements have     on brain responses and eating behavior in children. Food advertisements enhance children's     liking and intake of foods that tend to be high in energy content and low in nutritional     value. Although several studies have measured the differences in children's food intake after     watching advertisements, none have shown the brain mechanisms associated with this change in     behavior. In order to clarify the relationship between food advertising and eating behavior,     the investigators have assembled a team with expertise in functional imaging, eating     behaviors, and clinical pediatric research. First, the investigators will observe the     differences in children's eating behaviors after being exposed to food commercials or     non-food commercials. Second, the investigators will measure the difference in child brain     response to high and low energy foods after being exposed to food commercials or non-food     commercials. These data will allow us to identify which areas of the brain are specifically     affected by exposure to food commercials and correlate activity in these areas with     children's measured food intake in the laboratory. Forty children ages 7-9 will participate     in this 5-visit study which will be completed over the course of 12 months. Understanding how     food advertisements impact children's brain responses and subsequent eating behaviors will     have implications for understanding why some children respond differently to these cues than     others. These outcomes may also inform the development of more effective programs and     policies to prevent childhood obesity.   "
37956|NCT02788825|"     Prostate cancer is a leading cause of cancer death among men in the Western world. Early     detection of prostate cancer has been shown to decrease mortality, but has limitations with     low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The     STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer     using the blood-based STHLM3 test for identifying men at increased risk of harbouring     significant prostate cancer.      Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of     high-grade cancers compared to the currently used systematic biopsies, but existing evidence     are contradictory and not free from methodological flaws.      The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of     prostate cancer without decreasing the sensitivity of aggressive prostate cancers by     introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The     primary endpoints are the number of performed biopsies and the number of detected high-grade     prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of     low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded     disease after assessment of prostatectomy specimen. Additional aims include to assess the     health economic consequences of implementing MRI based prostate cancer diagnostics and to     improve the quality and effectiveness of prostate cancer diagnosis in the routine health care     in Stockholm.      The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately.     Based on power calculations, approximately 500 planned for prostate biopsies will be included     in the first phase. Men who have previously been diagnosed with prostate cancer may not take     part in the study. The study period of Phase 1 is March 2016 to January 2017. The second     phase will start in autumn 2016 and end by December 2017.   "
37957|NCT02788812|"     To determine if there is a difference in the quality of life in between patients who     undergoes laparoscopic transabdominal pre-peritoneal (TAPP) or modified Lichtenstein     hernioplasty   "
37958|NCT02788799|"     Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the     criterion usually used in practice to identify patients with acute coronary artery occlusion     and is essential for the direct and acute referral of patients for primary PCI. However, ECG     does not always reflect changes in the posterior wall of the heart, often equivalent to the     left circumflex coronary artery's (LCX) supply area, resulting in an underrepresentation of     LCX as culprit artery in STEMI populations. There is a general concern that some patients     with genuine acute occlusion of LCX may present without ST segment elevation and be denied     reperfusion therapy, resulting in larger infarction and worse outcome.      The aim of this trial is to implement record of posterior ECG leads (V7, V8 and V9) in     addition to the standard 12-lead ECG in the pre-hospital setting and to evaluate the clinical     impact of this implementation: In comparison to a control cohort of STEMI patients diagnosed     with a pre-hospital standard 12-lead ECG prior study start, the investigators hypothesize     that introducing V7-V9 leads as a clinical routine in the pre-hospital setting will identify     patients with STEMI involving LCX and with a non-diagnostic standard 12-lead ECG.   "
37959|NCT02788786|"     In Nepal, investigators are conducting a cohort study to estimate the relationship between     signs of periodontal disease in pregnant women and preterm delivery. Within that cohort     study, investigators plan to conduct an individually randomized trial of the acceptability     and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival     crevicular fluid and plaque during pregnancy. Women for this pilot trial will be chosen from     a subset of the area currently engaged in the larger cohort study, to simplify logistics. The     pilot trial will have four arms (three oral rinse arms, and one control group).        -  Arm 1: Twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with          periodontitis        -  Arm 2: Twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women with/without          periodontitis)        -  Arm 3: Twice daily oral rinse with salt and water (n=50: 25 women with/without          periodontitis)        -  Arm 4: No oral rinse (n=50)      To select and enroll these 175 participants, data collectors will use the information they     collected during an oral health clinical examination conducted at the time of enrollment into     the broader cohort study; this information will be used to classify women by signs of     periodontitis.      Those selected through this above process will be read an additional consent form; those     agreeing to participate will be provided with a supply of their assigned rinse (and     instructions on its use and handling/storage), or no rinse. Those in the three rinse groups     will be asked to use the provided rinse twice per day after brushing and to save the empty     bottles for collection by the health care worker. At the end of this first visit, women will     additionally provide a venous blood sample to measure systemic inflammation markers and     fluoride.      Women receiving the rinse will be visited by study workers periodically to provide more oral     rinse and check on their adherence to the rinse. All 175 women will be visited after 12 weeks     to undergo a second oral health clinical examination and provide a second set of gingival     crevicular fluid and plaque samples, to allow for evaluation of the effect of each of the     oral rinses as compared to the normal physiological changes in gingival inflammation and     biofilm composition during the course of pregnancy.      At this final visit, the women in the three rinse arms will also answer a short questionnaire     to gather feedback on acceptability and adherence to the oral rinse.   "
37960|NCT02788773|"     The purpose of this study is to find out the effects of giving durvalumab alone or in     combination with tremelimumab on this type of cancer. In addition, this study will look at     the side effects of durvalumab when given alone or in combination with tremelimumab.   "
38280|NCT02784600|"     The purpose of this clinical registry is to prospectively collect and compare preoperative     and postoperative patient-reported data using validated shoulder-specific and health-related     quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive     implant to treat rotator cuff tears.   "
37963|NCT02788734|"     The purpose of this study is to learn about focal compressive median neuropathy at the wrist     (Carpal Tunnel Syndrome) and outcomes of therapies (e.g. conservative and surgery) in the     upper extremities of patients diagnosed with an inherited neuropathy. All patients enrolled     in the Rare Diseases Clinical Research Network (RDCRN) Inherited Neuropathies Consortium     (INC) Contact Registry who have marked one of the following disorders: CMT1A, CMT1B, CMT2A,     CMT4, CMTX, other known CMT peripheral neuropathy, other unknown CMT peripheral neuropathy,     or Hereditary Neuropathy with liability to Pressure Palsies (HNPP), will be invited via email     to participate in this online study.   "
37965|NCT02788708|"     This phase I trial studies the side effects and best dose of lenvatinib mesylate when given     together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or     primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the     growth of tumor cells by blocking a protein needed for cell growth and may block the growth     of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving lenvatinib     mesylate and paclitaxel together may work better in treating patients with endometrial,     ovarian, fallopian tube, or primary peritoneal cancer.   "
37966|NCT02788695|"     A visual function focused add-on study to the Northern Ireland Cohort for the Longitudinal     Study of Ageing (NICOLA). There are three key aims:        1. Quantify age-related decline in a variety of visual functions within a populations based          cohort.        2. Explore the mechanisms underlying age-related visual impairments.        3. Investigate how visual function impacts vision related quality of life.   "
37967|NCT02788682|"     Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response     and is associated with clinical progression of many diseases. Our aim is to assess influence     of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs),     rs4588 (C>A) and rs7041 (G>T), on baseline clinical parameters and response to interferon     based therapy in chronic Hepatitis C patients in Egypt.      Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism)     in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be     assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.   "
37968|NCT02788669|"     Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the     third most common cancer in incidence and mortality in France. The vast majority of these     cancers are adenocarcinomas that arise sporadically and develop from precursor lesions:     adenoma. All CCR with the same disease stage do not have the same prognosis. Various     parameters have been identified as factors influencing the prognosis and allows adjustment of     the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor     or the mucinous adenocarcinoma subtype. At the molecular level, the presence of     microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF     mutation is an independent poor prognostic factor.      LRP-1 is a multifunctional endocytic receptor that belongs to the family of LDL receptors. It     is involved in the clearance of matrix proteases. A loss of expression or a decrease of the     LRP-1 activity is correlated with an increase of aggressiveness of cancer cells. This effect     was demonstrated in vitro in vesicular thyroid carcinomas after LRP-1 blocking. The decrease     in the immunohistochemical expression and LRP-1 genomic in hepatocellular carcinomas and lung     adenocarcinomas was correlated with a decrease in the overall survival. In CRC, only one     immunohistochemical expression study of LRP-1 in colonic adenocarcinoma has been published to     date. This study shows that tumor cells express LRP-1, but in nearly half the cases, weaker     than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon     cancer and its association with a particular molecular or morphological profile has not been     studied to date.      In this work, the investigators will study the immunohistochemical and genic expression of     LRP-1 in a series of colorectal cancers.   "
37969|NCT02788656|"     This pilot study will assess the impact of sacubitril/valsartan (trade name Entresto) on the     elevated pulmonary artery pressures in patients with heart failure with reduced ejection     fraction, measured using a previously implanted hemodynamic monitoring device (CardioMEMS).   "
37970|NCT02788643|"     Collagens are proteins present in all tissues. Besides their structural role, recent data     showed that they were able to regulate many cellular functions. Many interactions occur     between extracellular matrix macromolecules, especially collagen, and various cell types.     These interactions can be controlled by peptides derived extracellular matrix macromolecules,     called matrikines. Previous work from the investigators laboratory and others have shown that     several C-terminal domain (NC1 domains) from basement membrane-associated collagens could     regulate many cellular activities.      Lung is an organ particularly abundant in basement membranes. It is likely that various lung     diseases may affect metabolism of basement membrane associated collagens. To the     investigators knowledge, no study has focused on the expression of collagen XIX α1 chain and     collagen IV chains α3 and α4 chains in lung and studied possible variations of expression in     various pathophysiological situations.      The aim of this study are to:        -  Study the presence of collagen IV and XIX (or fragments) in different types of sampling          such as bronchoalveolar lavage, pulmonary aspiration and bronchial biopsies        -  Evaluate quantitative variations of expression of these collagen in different pulmonary          diseases, especially chronic obstructive bronchopneumopathy, infectious pneumonia,          pneumonitis or lung cancer.   "
37971|NCT02788630|"     This study will evaluate the efficacy of an intervention to improve quality and duration of     self-regulated nighttime sleep (the amount of time the child maintains a combination of     uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental     intervention).   "
37972|NCT02788617|"     This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological     assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.   "
37973|NCT02788604|"     In Canada, approximately 1450 children are diagnosed with cancer annually. Diagnosis of     childhood cancer and its aggressive treatment can have devastating psychosocial effects on     the whole family (e.g. unpleasant feelings or emotions that impact your daily activities). It     is not known whether health care providers who treat these children use and value     psychosocial tools or how beneficial the use of these tools is for these families. This     research team will test the benefits of using psychosocial screening on the quality of life     of treated children, parents and siblings.   "
37974|NCT02788591|"     Primary Objective:      Evaluate response to NERD treatment between patients with normal endomicroscopy findings     compared with patients with abnormal endomicroscopy findings.      Secondary Objectives:      To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating     dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.      Quality of life at study entry and end of study. Compare two medications under study within     each group as a subgroup analysis.   "
37977|NCT02788552|"     Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be     common in people with nutritional deficiencies or alcohol dependence. The primary cause of     WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent     patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may     lead to significant, long-term brain dysfunction with severe effects on work, personal and     social function. Whilst effective treatment may greatly reduce severe disability and the     human and social costs of this illness, almost no evidence exists on optimal dosing regimens.     This project proposes to develop quality evidence for effective treatment of WKS in an     Aboriginal setting.   "
37978|NCT02788539|"     This project will work to increase knowledge about the utility of a website for management of     chronic pain, Our Whole Lives (OWL). It will do so by examining barriers and facilitators to     patient use. In order to gather this information, the investigators will conduct a Science     Cafe with 30 individuals (including participants with chronic pain, who have family members     with chronic pain or are a stakeholder in the chronic pain community) to gather feedback     about how to tailor the OWL website to their needs and preferences and how to improve ease of     use for this tool. The investigators will also pilot two cohorts with 40 patients with     chronic pain (2 groups of 20 patients) with OWL, the patient-centered, mobile health chronic     pain management resource, measuring pain impact (pain severity, pain interference, physical     function) and pain associated outcomes (e.g., depression, anxiety, fatigue, sleep     disturbance, ability to participate in social roles and activities, pain self-efficacy,     health education impact and internalized stigma related to chronic pain).   "
37979|NCT02788526|"     Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second     leading cause of cancer-related death. Surgical resection is still the main radical approach     for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further     improvement of prognosis of HCC patients. The conventional risk factors of recurrence     including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the     microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after     hepatectomy. The investigators' previous study showed that the recurrence rate is more than     50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only     independent risk factor for the overall and disease-free survival of HCC patients in multiple     variables analysis. It is important to reduce the recurrence and prolong the survival of     patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an     adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the     investigators design the current prospective randomized clinical trial to evaluate the effect     of adjuvant TACE to reduce the recurrence in HCC patients at high risk (>5cm solitary tumor     and MVI) after resection, compared to vigilant follow-up.   "
37980|NCT02788513|"     The study is designed to compare the effects of BI 425809 compared to placebo in patients     with cognitive impairment due to Alzheimer's Disease.   "
37981|NCT02788500|"     The overall aim of this project is to gain an in-depth understanding of the epidemiology of     sports-related injuries and illnesses in parasport in order to assist the identification and     development of specific injury prevention strategies adapted to parasport.   "
37982|NCT02788487|"     The objectives of this study is to compare short-term outcomes of CPAP and TRD in the     treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during     3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree     of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.   "
37983|NCT02788474|"     Identifying biomarkers to predict the clinical course and benefits of therapy early in the     course of the disease remains one of the most urgent and relevant challenges to improve     overall patient management, to prevent treatment delay or overtreatment. This study is     conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of     extracellular matrix turnover which have been shown recently to correlate with disease     progression. This study further aims to confirm the association of biomarker course during     the first three months of treatment and disease progression.   "
37984|NCT02788461|"     A randomized phase II trial to assess the efficacy and safety of selective metabolically     adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving     definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive     conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost.     All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan     within two weeks prior to starting treatment. The primary outcome is to determine if dose     escalation to metabolically active tumor subvolumes will reduce local-regional failure rate     at 2 years.   "
37985|NCT02788448|"     The purpose of this Clinical Investigation is to validate that the clinical use of the     VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm     its performance to percutaneously close femoral arterial puncture sites in the range of 18-24     F, post endovascular procedures.      This is a non-inferiority study based on safety. Safety will be assessed by incidence and     severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3     months from implantation is no worse than those associated with cut-down and sutured close.   "
37986|NCT02788435|"     Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest     postoperatively. However, no clinical trials have ever been conducted to ascertain the     efficacy of using voice rest and its impact on functional voice outcomes. The purpose of this     randomized-clinical trial is to determine if the prescription of voice rest has an impact on     voice outcomes following phonosurgery.   "
37987|NCT02788422|"     Thorough, understandable discharge instructions empower caregivers, allowing them to provide     optimum care of their children during illness. Unfortunately discharge instructions are often     incomplete and difficult to understand. The use of video discharge instructions has been     shown to increase patient understanding of their illness. The investigators would like to     know if using video discharge instructions for caregivers of children with middle ear     infections helps to better understand how to take care of children at home, potentially     allowing the child to feel better faster. The investigators will be comparing video discharge     instructions to a paper handout to see if the former leads to improved well-being of the     child and improved caregiver knowledge, satisfaction and anxiety.   "
37993|NCT02788344|"     This is a multicenter multidisciplinary study designed to investigate patient, provider, and     system-related factors that are associated with the quality and safety of initial management     for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12     hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for     suspected STEMI independently relates to provider practice patterns and system barriers. It     is further postulated that non-compliance with target delays in implementing percutaneous     coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital     clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion     therapy within target delays is associated with increased rates of false-positive cardiac     catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding events.      The project will be conducted in three emergency medical services and 23 public and private     (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over     the index hospital stay period will be retrospectively collected for all the patients     included in an ongoing prospective regional hospital-based clinical registry of suspected     STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is     anticipated.      In this observational retrospective study, no specific intervention is assigned to     participants. All diagnostic testing, procedures, and medication ordering are performed at     the discretion of attending physicians. No enrollment or follow-up visits are planned.      The primary effectiveness outcome is timely acute reperfusion therapy. The secondary     effectiveness outcomes include false-positive cardiac catheterization laboratory activation     for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical     outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and     major bleeding events. Multivariable logistic regression model will be developed to identify     baseline characteristics that are independently associated with timely acute reperfusion     therapy. Propensity score analysis will be performed for comparing clinical outcomes between     timely acute reperfusion therapy recipients and non-recipients.   "
37994|NCT02788331|"     The explanatory mechanism of the relationship between the volume of surgical procedures     performed by individual hospitals and the occurrence of serious adverse events is not clear.     Based on the  practice makes perfect  dogma, we will explore whether a learning effect can     explain the volume-outcome relationship for complex surgical procedures using a nationwide     dataset. Especially, we assume that increasing volume of procedures over time may be     associated with improved outcomes.   "
37995|NCT02788318|"     The mortality rate is increased in patients with epilepsy, and especially among patients with     drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP     whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The     term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic     and post-mortem evidence does not identify a particular cause. Experimental and clinical data     strongly suggest that most of SUDEP result from a postictal respiratory dysfunction     progressing to terminal apnea. Due to the major role of serotonin in regulating breathing     rhythms and data in animal models of epilepsy, it is envisaged that an alteration of     serotonergic systems of the brainstem and limbic regions may play a central role in the     occurrence of SUDEP. The objective of this work is to look for abnormalities of the     serotonergic transmission within regulatory regions of respiratory and autonomic functions in     brain samples prospectively collected in patients died from SUDEP.   "
37996|NCT02788305|"     This study investigate the progression of labour in 459 normal weight pregnant women (BMI     <30) and 459 obese pregnant women (BMI <30) , not in labor admitted for induction of labor.     These women are to be investigated for success of induction of labor.   "
37997|NCT02788292|"     A single-centre triple-blind study looking at the addition of NAC to tumescent solution for     liposuction and fat grafting in healthy patient volunteers already undergoing bilateral     breast reduction. Three-dimensional reconstructions and volumetric analysis will be performed     based on CT scans at 0, 1 and 3 months and then histological analysis will be performed after     fat graft explantation at 3 months to determine fat graft vascularity and quality.   "
38330|NCT02783924|"     The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in     adipose tissue will be studied in 50 subjects.   "
37999|NCT02788266|"     Background: The aim of this study was to evaluate the treatment of multiple gingival     recessions associated with non-carious cervical lesions (NCCL) using a modified coronally     advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on restored     root surfaces.      Methods: Twenty-three systemically healthy subjects, who were positive for the presence of     three cervical lesions associated with gingival recessions in three different adjacent teeth,     were enrolled in the study. The NCCL were each restored prior to surgery by using one of     three different materials: composite resin (group 1), resin-modified glass ionomer cement     (group 2) or giomer (group 3). The defects were treated with SCTG. Clinical measurements,     including plaque index (PI), bleeding on probing (BOP), relative recession height (rRH),     probing depth (PD), cervical lesion height (CLH), relative clinical attachment level (rCAL),     keratinized tissue height (KTH), keratinized tissue thickness (KTT), percentage of root     coverage (RC), and percentage of cervical lesion height coverage (CLHC) were recorded at     baseline, 3 and 6 months, and 1 year postoperatively.   "
38000|NCT02788253|"     Mallampati score (classification of the visibility of oropharyngeal structures) should be     performed in the sitting position, head in the neutral position, mouth widely open, and     tongue protrudes, without phonation. However, phonation, and position modify the visibility     of oropharyngeal structures and thus the Mallampati score. Furthermore, some patients cannot     be evaluated in sitting position because (emergency, fractures, pain, supine position require     for medical or surgical pathology...).      We aimed at evaluating the predictive value of the best observable Mallampati score as     compare to the recommended Mallampati score.   "
38001|NCT02788240|"     All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of     liver and biliary sciences, irrespective of the etiology , who have survived the acute phase     (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to     participate in the study would be enrolled. After performing baseline biochemical tests,     patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure     Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and     immunohistochemical examination will be done).   "
38109|NCT02786823|"     This study aims to evaluate the effect of Folic acid and Vitamin B12 supplementation on     Biochemical parameters in subjects with type-2 Diabetes. 80 selected subjects will be divided     into 4 groups of 20 each.        -  Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral          anti-diabetic drugs;        -  Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral          anti-diabetic drugs;        -  Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily          for 8 weeks along with standard oral anti-diabetic drugs;        -  Group D: to receive no additional intervention apart from standard oral anti-diabetic          drugs.      The biochemical parameters will be evaluated before and after the intervention.   "
38002|NCT02788227|"     Background:      The Ebola virus causes a severe disease. It can be fatal. The usual incubation period after     being exposed is 2 to 21 days. There is no approved treatment for Ebola infection. There is     also no vaccine to prevent infection either before or after exposure. Researchers want to     test an Ebola vaccine. They want to give it to people before they are exposed to the virus in     order to prevent the disease.      Objectives:      To see how long-lasting and effective the vaccine rVSV[delta]G ZEBOV-GP (V920) is at     preventing Ebola.      Eligibility:      Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical     contact.      Design:      Participants will be screened with medical history, physical exam, and blood tests.      Participants will get the study vaccine. It will be injected into their upper arm.      Participants will be monitored closely for at least 30 minutes. They will get a diary card to     record any symptoms they have from the vaccine for up to 14 days.      Participants will have study visits at 1, 3, and 6 months after they get the vaccine, then     every 6 months (that is, at months 12, 18, 19, 24, 30, and 36 of study) for a total of 36     months.      Eighteen months after they join the study, participants will be randomly assigned to one of     two groups. One group will get a second (or booster ) dose of the vaccine. The other group     will not get a second dose.      This study lasts 36 months.   "
38003|NCT02788214|"     Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems     or stomach cancer. Researchers want to look at samples of the bacteria. These will be taken     from chronically infected people. They want to identify the genetic differences in H. pylori     strains. This could help predict which people who get infected with the bacteria will get     cancer. This could lead to the cancer being detected earlier. It could also mean less people     get stomach cancer.      Objectives:      To study genetic variations of H. pylori strains based on samples from chronically infected     people. To identify the features of strains that might lead to severe stomach problems or     stomach cancer.      Eligibility:      People ages 35 70 who need an upper endoscopy or who were recently diagnosed with stomach     cancer      Design:      Participants will be screened by the doctor who does their procedure and a study nurse.      Participants who have endoscopy will have 6 biopsies removed. These are tissue samples. They     are about the size of a grain of rice. Participants will allow the study team to access     reports from their stomach exam.      Participants with stomach cancer will donate some of the tissue that will be removed during     their clinical care. They will allow the study team to access reports of their surgery. They     will also allow them to access the microscope slides of their stomach.   "
38011|NCT02788110|"     Background:      Non-invasive forms of respiratory support have been developed to manage respiratory distress     and failure in premature newborns without exposing them to the risks associated with invasive     mechanical ventilation. It has been difficult to synchronize non-invasive ventilation due to     the large air leaks, high respiratory rates, and small tidal volumes inherent to this     interface and population. Neurally adjusted ventilatory assist (NAVA) is a novel mode of     ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect     diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize     ventilator support to the patient's own respiratory efforts and to support these efforts as     needed. Few studies have examined the use of NAVA with non-invasive ventilation (NIV) in     preterm neonates. A group at Arkansas Children's Hospital recently completed a study, looking     at work of breathing in an animal model comparing NIV NAVA with the unsynchronized nasal     intermittent positive pressure (NIPPV) mode currently used at this hospital. They were able     to show that work of breathing was lower with NAVA in this model. This study will take what     was shown in the animal model and translate this to the bedside. Using respiratory inductance     plethysmography to measure thoracoabdominal asynchrony, this study will compare work of     breathing during NIPPV versus NIV NAVA in preterm neonates with respiratory insufficiency.      Hypothesis:      Work of breathing as estimated by the phase angle (θ) using respiratory inductance     plethysmography will be decreased with the use of NIV NAVA in comparison to unsynchronized     NIPPV in premature neonates with respiratory insufficiency.      Methods:      Fifteen premature neonates of between 1-2 kilograms' current weight, with gestational age at     birth between 24-34 weeks, and receiving non-invasive ventilation will be enrolled in the     study after consent is obtained. The infants will be ventilated using NIV NAVA and NIPPV     applied in random order for 15 minutes each while using respiratory inductance     plethysmography to measure thoracoabdominal asynchrony as an estimate of work of breathing.      Significance:      This study will identify whether or not NIV NAVA has advantages over NIPPV for improving work     of breathing in premature neonates.   "
38004|NCT02788201|"     Background:      Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested     for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to treatment.     It may also help determine which drugs fight urothelial cancer based on the characteristics     of a tumor. Researchers want to test if this model can choose the best therapy for advanced     urothelial cancer within 3 weeks and how tumors respond to the next best therapy.      Objective:      To test if the COXEN model can choose the best therapy for advanced urothelial cancer within     3 weeks.      Eligibility:      People ages 18 and older whose urothelial cancer has spread after at least 1 line of     chemotherapy      Design:      Participants will be screened with medical history, physical exam, blood and urine tests, and     tumor scans.      Participants will provide a tumor sample from a previous surgery and a new biopsy. A needle     will remove a small piece of tumor.      Participants will repeat screening tests, plus have an EKG and scan. For the scan, they will     get an injection of radioactive drug. They will lie in a machine that takes pictures.      Participants will take the drugs assigned by the COXEN model. They will have visits every 2 3     weeks. These will include blood and urine tests.      Participants will have tumor scans every 8 9 weeks.      Participants may have another biopsy.      Participants will take the drugs until they can t tolerate the side effects or their cancer     worsens. They may be assigned to a second COXEN therapy.      Participants will have a follow-up visit 4 5 weeks after their last drug dose.      Participants will be contacted by phone every few months until death.   "
38017|NCT02788032|"     This open-label, prospective, controlled intervention study involves evaluating tolerance and     acceptability of an Oral Nutrition Supplement (ONS; EnergieShake®) in 16 adult patients who     are already taking an ONS. Following a 2-day baseline data collection on their current ONS,     patients switch to the test ONS, which is taken for a further 8 consecutive days. Patients     revert to their current ONS at the end of the study. Patients act as their own controls and     thus all patients are allocated the same intervention.      Daily records of GI tolerance and compliance with the prescribed amount of ONS will be kept     for participants throughout the study period. Participants' height and weight will be     collected at baseline (weight at end will also be collected), all medications will be     documented, and relevant medical and dietary histories will be recorded. A questionnaire at     the end of the intervention period will be administered collecting participants' views on the     acceptability (taste and palatability) of the test ONS. Taste and palatability will be     assessed via a questionnaire that uses a Hedonic scale to quantify preference.   "
38110|NCT02786810|"     The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal     ultrasound.   "
38005|NCT02788188|"     Background:      Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal     respiratory virus. People often get MERS through close contact with an infected person.     Scientists are worried that MERS may spread and cause more infections. There are no vaccines     or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able     to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of     antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid     part of cow blood.      Objective:      To evaluate the safety and tolerability of SAB-301 in healthy adults.      Eligibility:      Healthy people ages 18 60 who:      Do not have chronic medical problems      Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal     allergy meds and oral contraception)      Do not have allergies to beef products      Agree to use two forms of contraception while on study (both men and women)      Design:      Participants will be screened with:      Medical history      Physical examination      Blood and urine tests      Participants will have a return visit.      They will have a physical exam and blood tests.      They will be randomly assigned to receive either SAB-301 or a placebo which is given by     infusion      through an arm vein over 1 3 hours.      They will be monitored at the clinic for 6 hours after the infusion. They will have     additional blood draws.      Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each     visit they will be evaluated and have blood and urine tests.   "
38006|NCT02788175|"     Background:      In most people infected with human immunodeficiency virus (HIV), their immune system cannot     control HIV infection. They need drugs called combination antiretroviral therapy (cART) to     control the HIV. When people stop cART treatment, their immune system cannot control the     infection again. They can also become resistant to cART and have lasting side effects.     Researchers want to test if the drug vedolizumab is effective at controlling HIV infection     without the need for cART.      Objective:      To teste if vedolizumab is safe and can control the amount of HIV in the blood when cART is     not taken.      Eligibility:      People ages 18-65 who have HIV and are being treated with cART      Design:      Participants will be screened with:      Physical exam      Medical history      Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity.      Blood and urine tests      Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It     will include repeats of the screening tests and:      Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white     blood cells from the blood. The rest of the blood is returned to the participant.      Neurologic exam: The nerves and reflexes are tested.      First vedolizumab infusion through an arm vein      Participants will have visits every 4 weeks for 30 weeks. These will include:      Vedolizumab infusions      Repeats of baseline tests      Participants will have more visits for blood draws.      Participants will keep taking cART until after the week 22 infusion.      After discontinuing cART at study week 22, participants will be seen every two weeks to     monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in     between infusion visits and will only take about 1 hour to complete. cART will be restarted     if a participant s HIV levels go up to high, or if their CD4 cell counts decreases by too     much.      For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. These will     include blood tests and a physical exam.   "
38007|NCT02788162|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
38008|NCT02788149|"     To investigate the accuracy of neck ultrasound in identifying and discriminating the severity     of obstructive sleep apnea (OSA).      Primary objective: To test the hypothesis that ultrasound can be used as a reliable tool for     identifying the anatomic characteristics and dynamic changes of pharyngeal airspace in     patients with OSA.      Secondary objective: Investigate if ultrasound can be used to discriminate OSA severity.      The investigators will compare these results to the results from polysomnography study.   "
38009|NCT02788136|"     The study design included six visits. During the first visit (visit 0), the subjects     underwent physical examination(height, weight, body mass index (BMI), arm span, and upper     segment measurement) and testicular ultrasound (US) for the calculation of testicular volume.     At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a     single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of     five following consecutive days after the hCG injection. A blood sample was taken at each     visit after an overnight fast   "
38010|NCT02788123|"     The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium     dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in     subjects with NSAID-induced gastropathy in 14±2 days of treatment.   "
38012|NCT02788097|"     In recent artificial frozen embryo transfers (FET) in which blastocysts vitrified on day 4 of     culture and transferred on P+4, with blastocysts traditionally transferred on P+5, a high     rate of implantation has been observed. In addition, a greater number of these implantations     resulted in clinical pregnancies (i.e., a conceptus with normal fetal heart activity). In     this prospective randomised control study, the investigators will investigate whether this     increased viability, is due either to embryo quality, endometrial receptivity, or a     combination of the two factors by randomizing the transfer of day 5 blastocysts to P+4 or     P+5.   "
38130|NCT02786550|"     The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle)     and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty     incision whereas the scar is more visible on patient.      The main aim of this trial is to investigate whether the injection of Botulinum toxin into     the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower     blepharoplasty.   "
38013|NCT02788084|"     1. Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of          formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens.        2. Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas          (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements          common to both FPPE and cfDNA specimens.        3. Determine if certain types of BNHL are more likely to have mutation profiles common to          both FFPE & corresponding cfDNA (FFPE-cfDNA dyads)        4. Determine if specific mutations or mutation profiles in FFPE or cfDNA specimens (or          both) are of prognostic value after a clinical follow-up of 2 years from the time of          diagnosis.   "
38014|NCT02788071|"     The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will     result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).   "
38015|NCT02788058|"     To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy     for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI     therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.   "
38132|NCT02786524|"     To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic     improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy     patients compared with symptom management performed by the primary gynecologic oncologist.   "
38018|NCT02788019|"     This is a randomized noninferiority interventional study to determine the equivalence of two     adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial     foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during     their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day     Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and UTSW Outpatient Surgery     Center) for eligibility. Eligible individuals may be introduced to the study in the     orthopedic presurgical clinic or the anesthesia preoperative clinic by staff. After consent     patients will be randomized (break-seal method) to receive either a mid-thigh or distal thigh     block using ropivacaine prior to foot, ankle, or leg surgery. The following measurements will     be obtained to determine the change in sensory distribution: pinprick test with Neuropen,     maximum voluntary isometric contraction before and after block, postoperative pain scores (24     hrs and at discharge) and postoperative opiate consumption.   "
38019|NCT02788006|"     Multicenter prospective phase II study evaluating regorafenib in older patients with     metastatic colorectal cancer   "
38020|NCT02787993|"     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine     the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive     behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety,     depression), pain, and fatigue in women with advanced stage breast cancer in Singapore and     the US.   "
38021|NCT02787980|"     Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born     at full term.      Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea).     Study the relationship between the onset of infectious complications, mainly the type of     necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the     evolution profile of serum tryptase levels.   "
38022|NCT02787967|"     The study will be conducted in asthmatic children aged 5 to 11 years and is based on a     single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI)     fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4     μg is compared with the free combination of licensed BDP DPI and FF DPI   "
38023|NCT02787954|"     The purpose of this study is to determine if MRI imaging can detect genetic, proteomic, and     metabolomic characteristics of liver tumors. The study also aims to determine if these     imaging characteristics are correlated with clinical outcomes.   "
38024|NCT02787941|"     Adherence to treatment in post-acute coronary syndrome patients has been found to be poor in     several studies. Pharmacists play a significant role in enhancing medication adherence and     reducing rates of mortality and re-admission to hospital by performing medication     reconciliation and tailoring, and patient education. The purpose of this study is to     determine the effect of pharmacist-delivered multifaceted intervention on medication     adherence and clinical outcomes of post-acute coronary syndrome patients. The study will be     designed as a randomised controlled trial with blinded outcome assessors. The population     includes patients who survive during hospitalisation with discharge diagnosis of acute     coronary syndrome. Pharmacist-delivered multifaceted intervention consists of two counselling     sessions within 1 week before and after hospital discharge including medication     reconciliation and tailoring, and support with pill organiser and drug information leaflet.     Primary outcome measure is the proportion of patients adherent to medication at 1 month after     discharge. Secondary outcome measures are the proportions of patients (1) adherent to     medication at 3 months after discharge, (2) readmitted to hospital and (3) dying within 3     months after discharge. The investigators also measure (4) the change in quality of life and     (5) beliefs about medicines from baseline at 3 months.   "
38331|NCT02783911|"     Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric     Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months     and 12 months.   "
38025|NCT02787928|"     In the United States the incidence of cesarean deliveries have increased over the last     several decades and is currently approximately 30% nationwide. The anesthesia and analgesia     for elective c-sections vary between institutions.      Parturients present a unique challenge for the anesthesiologist as the mother has to care not     only for herself, but also for the newborn postpartum. While intrathecal opioids provide     adequate pain relief, they do so at the cost of bothersome side effects for patients, such as     pruritus and nausea/vomiting.      Intrathecal hydromorphone has started to be explored as a new option for intrathecal     analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of     intrathecal dilaudid was safe and effective as compared to intrathecal morphine for analgesia     after cesarean delivery. Additionally they showed no difference in side effect profiles of     the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal dilaudid     with hyperbaric bupivacaine in varying dosages for labor analgesia. The results were     inconclusive, but the dosage of hydromorphone was reported to be without adverse effects.      Virginia Commonwealth University Health Systems has successfully instituted the use of     intrathecal morphine with superior analgesia but with undesired side effects, most notably     pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative     options for post cesarean section analgesia. The investigators are interested in determining     the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our     institution has never utilized intrathecal hydromorphone for our patient population, it has     been studied at various other institutions where it has been found to be safe and efficacious     with an acceptable side effect profile.   "
38026|NCT02787915|"     This trial is to evaluate the safety and effectiveness of autologous type-1 polarized     dendritic cell vaccines (patients' autologous DC1s loaded with multiple antigens CTL epitope     peptide complexes), after radical resection for patients with stage III-IV renal cell     carcinoma. Autologous cytotoxic of T lymphocytes (CTL) induced by type-1 polarized dendritic     cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .   "
38049|NCT02787616|"     Rosacea is a common disease characterized by inflammation and vascular abnormalities of the     facial skin and ocular surface. The exact pathogenesis of papulopustular rosacea is not well     understood and current methods to treat this disease are often unsatisfactory. The purpose of     this study is to develop gene expression profiles of papulopustular rosacea compared to those     of normal skin. The investigators hope to better understand the abnormal gene functions that     might contribute to this condition. This understanding may lead to the development of     additional and better treatments for rosacea.   "
38027|NCT02787902|"     The purpose of this study is to develop, implement, and evaluate a behavioral weight     management intervention with a communication training component for Mexican-American women.     The study has three specific aims.      Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral     weight loss treatment using results from formative data collected from Mexican-American     mother-daughter dyads. The adapted intervention will focus on improving dyadic communication     and collaboration for providing reciprocal support for healthy eating and physical activity     behaviors.      Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter     dyads. Dyads will be randomly assigned to partner-based treatment with or without     communication skills training.      Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and     psychosocial variables with changes in measures assessing interpersonal communication.   "
38028|NCT02787889|"     The investigators determined effects of 8-week dietary protein intake in mixed meals with     uneven or even consumption pattern on the metabolic outcomes of whole-body net protein     synthesis and muscle protein synthesis in older participants.   "
38029|NCT02787876|"     To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in     children with solid tumors   "
38030|NCT02787863|"     Goal: to to examine the formation of postvaccination immunity and evaluate the therapeutic     effect of bacterial vaccines in patients with inflammation diseases of bronchopulmonary     system. Objectives of the study: assessment of microbiocenosis mucous membranes of the upper     respiratory tract in patients with bronchopulmonary pathology before and after use of     bacterial vaccines. Identification of mayor lymphocytes subpopulations, proinflammatory     cytokines, inflammatory markers in patients in the dynamics of the vaccination process. Study     the profile of humoral immune response in patients under different schemes of vaccination.     Detection of levels of autoantibodies against tissue antigens in the sera of vaccinated     patients with inflammatory diseases of the respiratory tract. Assessment of the clinic and     functional status bronchopulmonary system in the immunized patients. Development of     methodical recommendations / study guides for the improvement of therapy in patients with     different inflammation diseases of the respiratory tract.   "
38031|NCT02787850|"     Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the     abdomen using an applicator with the Crown Cooling Insert.   "
38032|NCT02787837|"     Prospective Multi-centre Studies of Prognostic Factors in Castration resistant PROState     Cancer Treated With Abiraterone (PROSABI)   "
38033|NCT02787824|"     The purpose of this study was to compare the efficacy of two regimens of intravenous iron     sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on     the response of rHuEPO in the maintenance phase of its administration in hemodialysis     patients.   "
38034|NCT02787811|"     Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young     Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle,     followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon;     FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of     17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge,     5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.   "
38035|NCT02787798|"     The hyperactivation of the sympathetic nervous system is a feature of the heart failure and     the determinants of disease progression and risk of sudden cardiac death. This research     project aims to study, in the drug use conditions provided in the summary of product     characteristics based on European marketing authorization (indications and dosage), the     effect of the Entresto® on the activity of sympathic nervous system using the reference     method, the microneurographic recording of sympathetic activity in muscle destiny (MSNA).     This study will try to determine if the double inhibition of AT1 receptor and neprilysin     activity result in lower sympathic nervous system burst rate versus single AT1 receptor     inhibition using angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II     inhibitor.   "
38036|NCT02787785|"     The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction,     diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival     benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when     compared to those receiving conventional medical therapy.   "
38037|NCT02787772|"     Cirrhotic patients have a high incidence of abdominal wall hernias. Ascites and sarcopenia     are risk factors to development of bigger hernias and frequent need for urgent surgery due     parietal complications. However, hernia surgery is usually delayed in cirrhotic patients     because of high morbidity and mortality.      Methods: A prospective study of cirrhotic patients with abdominal wall hernia during January     2009 to November 2014. Demographics, characteristics of underlying liver disease, type of     hernia, complications and mortality of 246 enrolled patients were collected. Elective hernia     repair was performed in 57 unselected patients, 186 patients were kept in clinical follow up.     During follow up urgent hernia surgery was performed when unavoidable   "
38038|NCT02787759|"     We propose a study that uses challenging walking exercises as a research training program and     compare balance and walking abilities against a non-challenging exercise program, in a group     of 40 people with long standing (> 6 months) weakness that occurred after a stroke. Our main     balance measure will be changes with the Berg Balance Score and Dynamic Gait Index, and our     main walking measure will be walking speed over a 10 meter walkway and distance walked over a     six minute period. Also, we will measure balance confidence, using scores on     Activities-specific Balance Confidence Scale, changes in quality of life as measured by the     Geriatric Depression Scale, SF-36 and Stroke Impact Scale. If challenging exercises are shown     to be more effective than non-challenging exercises, then we will share this promising new     approach with the community in hopes of improving people's lives after a stroke.   "
38039|NCT02787746|"     This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in     China.   "
38069|NCT02787356|"     The purpose of this study is to (1) collect trained observer scores and digital images of     skin irritated by generic and RLD Lidocaine 5% delivered via TDS, and (2) assess performance     of an automated system for predicting scores directly from the digital images   "
38040|NCT02787733|"     Rationale: Numerous studies have shown the positive effect of a healthy diet and regular     moderate exercise. Although, exercise has also been correlated with an increase in reactive     oxygen species (ROS) production and a higher incidence of injury. ROS production seems to     induce muscle damage, which reduces muscle performance and induces fatigue. Increasing muscle     recovery could be an effective way to increase exercise performance. Several food ingredients     have been of growing interest due to their specific functioning on the human body. Citrus     flavonoids are abundantly available in citrus fruits. Prior studies show a positive effect of     citrus flavonoids on endothelial function, by promoting vasodilation. In addition it has a     positive effect on the nitric oxide (NO) synthesis, a known compound in regulating     endothelial response. This capacity of citrus flavonoids could be useful in stimulating     performance and recovery after exercise. Additionally, the ability of scavenging ROS could     reduce muscle damage caused by exercise induced oxidative damage.      Objective: Determine the 4-week effect of daily citrus flavonoid supplementation on exercise     recovery and performance.      Study design: Randomized, double-blind, placebo-controlled study with parallel design, in     which 40 subjects engage in three exercise sessions. The sessions will be subdivided into a     pre-test and test 1 and 2. Between test 1 and 2, participants receive daily for 4 weeks     citrus flavonoid supplement or a placebo. Each day, subjects should consume 2 capsules each     morning, containing in total 500 mg of citrus flavonoids or 500 mg placebo.      Study population: The subjects will be healthy normal weight trained males, with an age of 18     - 25. Additionally, subjects are non-smokers and free of a medication.      Intervention: Participants will be randomly placed in either the citrus flavonoid or placebo     group. Participants will be instructed to ingest 2 capsules each morning for 4 consecutive     weeks. Each capsule equals to 250 mg of citrus flavonoids or cellulose in case of the placebo     treatment.      Main study parameters/endpoints: The main study parameter is the average amount of work load     produced during the 10-minute time trail test. In addition, oxygen per minute will be     determined as well as the heart rate. Finally, for each test, the subjective rating of     perceived exertion (RPE) will be determined during the pre-test and test 1 and 2 by using a     Borg scale.   "
38041|NCT02787720|"     A randomized controlled blinded study in patients treated for Acute Respiratory Distress     Syndrome (ARDS) in the mixed medical-surgical intensive care units (ICU) of four academic     teaching hospitals in Tehran, Iran were conducted to examine the effects of Varied     Rehabilitation Techniques on Survivors of ARDS patients. Patients were randomized in the     emergency department at the time of ICU admission to one of four groups labeled groups 1, 2,     3 and 4, respectively.   "
38042|NCT02787707|"     The main objective of this research is the role of the Persumac(an Iranian traditional     remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer     patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting     in acute and delayed phase.   "
38043|NCT02787694|"     Locomotor disability remains a major obstacle to community function in stroke survivors. This     disability is best characterized by the reduced gait speed and enhanced risk of falls that is     observed in the majority of stroke survivors. Current robotic systems have focused on     repetitive stepping in constrained, less-challenging environments than overground training     and have failed to produce results that can justify their use. In contrast to this approach,     this study will use a combinatorial approach on a moving platform (KineAssist-Mobility     Activity Center) that simulates and enhances the challenges of overground training. We focus     on five critical factors that contribute to reduced speed and fall risk during mobility     activities: 1) lower limb weakness; 2) slow lower limb movements; 3) reduced balance; 4)     reduced ability to respond to challenges during walking; and 5) reduced aerobic capacity. The     end product of this study is to develop a comprehensive and standardized system for assessing     and prescribing specific training modalities that can be used by clinicians to help stroke     survivors who are limited by slow walking speed and high fall risk, and can improve     participation in mobility activities.   "
38044|NCT02787681|"     The aim of this study is to verify the safety and accuracy of an FDA-approved device called     the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in     the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge     is able to properly determine the correct position of the endotracheal tube without the use     of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68)     subjects will participate in this study at three (3) study centers in the Inland Empire of     Southern California, with subjects being enrolled at Loma Linda University Medical Center,     Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.   "
38045|NCT02787668|"     The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat     diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation,     insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver     disease (NAFLD).   "
38065|NCT02787408|"     The purpose of the study is to assess the safety and device performance of the Edwards     Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic,     tricuspid regurgitation who are at high surgical risk for standard tricuspid     repair/replacement.   "
38151|NCT02786277|"     In this trial, individuals with Acute Kidney Injury will be randomized to usual care or to an     electronic AKI alert system. In three phases, the alert system will be trained to identify     those most likely to benefit from the alert, and inclusion criteria will be modified.   "
38046|NCT02787655|"     The purpose of this study is to examine the impact of a combined cognitive training and     aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic     exercise will potentiate and increase the generalizability of the cognitive training.     Importantly, this study will focus on older adults at-risk for mobility disability. This area     is of particular importance considering a large percentage of adults are entering old age and     therefore likely to suffer from age-related cognitive decline and mobility disability.      To address the investigators' research question 60 adults (age 18-89) will be randomized to     one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic     Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the     same format shown to improve a broad range of executive functions in older adults in previous     research. The cognitive training arm will consists of a popular commercially-available brain     fitness program that has demonstrated specific cognitive improvements and high adherence.   "
38048|NCT02787629|"     Patients presenting for elective surgery requiring orotracheal intubation will be randomized     to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then     having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in     the more common fashion with the GlideScope being inserted first and having the ETT then     advanced via the pharynx into the trachea.   "
38410|NCT02782871|"     Following major head and neck surgery it may be necessary to keep patients intubated and     ventilated for at least 12 hours to allow the swelling associated with the operation to     subside. Therefore patients (participants) are transferred to the intensive care unit     anaesthetised, in-tubated and ventilated. Current practice is that patients are manually     ventilated, by hand, during transfer from the operating theatre to the intensive care unit.   "
38050|NCT02787603|"     Introduction: Acute Heart Failure is frequently decompensated by pulmonary infection, but the     diagnosis of pulmonary infection sometimes is difficult in these patients due to similar     signals and clinical symptoms in both pathologies. Furthermore, when it is possible the     diagnosis of pulmonary infection, physicians may have difficult to determine etiology and     delaying antibiotic therapy. Procalcitonin (PCT) have been used like a biomarker to determine     the period of use of antibiotics in patients with acute respiratory infections. It is     specific for bacterial infections and it have showed as a marker of severity infection and     may help to determine interruption period of antibiotic therapy in a safety way for the     patient. Aim: Evaluate levels of PCT related to interruption of antibiotics in patients with     decompensated acute heart failure (DAHF) with suspected bacterial pulmonary infection.     Methods: In this pilot project will be included around 100 patients, randomized in two     groups: group A (PCT levels may guide the interruption of antibiotic at day 5) or group B     (antibiotic period will be determined by the physician without the knowledge of PCT levels).     Will be collected laboratorial and clinical data at days 0,3 and 5. Both groups will be     compared to evaluate PCT levels and total period of antibiotic therapy, hospitalization and     readmission in 30 days. This study will determine the sensibility/specificity of PCT in     patients with DAHF.   "
38051|NCT02787590|"     Participants are randomly allocated to one of two treatment groups. In one group,     participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In     the other group, participants are given placebo (dummy) capsules to take orally for 24     months. At the start of the study, when they receive their medication, participants complete     a number of questionnaires and motor (movement) tests (a walking test and a finger tapping     test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18     and 24 and 26 months, where they are asked about their health and any medication they are     taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits,     the participants will be asked to attend in the 'OFF medication' state (having omitted their     usual PD medication) so that the researchers can get a true picture of their disease without     it being masked by their normal medication.   "
38052|NCT02787577|"     Short sleep duration has been associated with increased risk of weight gain and development     of non-communicable diseases. Sleep deprivation studies have suggested the link between     restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal.     However, the severity and acuteness of sleep restriction schedules in laboratory-based     studies could hinder the ecological validity of the findings. The pragmatic way forward is to     assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes.     This study assesses the feasibility of lengthening sleep in short sleepers, as well as how     improved sleep duration and/or quality impact metabolic health, body composition, energy     balance and cardiovascular risk.   "
38053|NCT02787564|"     The study aims to investigate whether the provision of free fresh fruits and vegetables to     middle-aged men at risk of poverty increases their fruit and vegetable intake over a period     of 4 weeks.   "
38054|NCT02787551|"     Primary Objective:      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination     (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.      Secondary Objectives:      To compare the overall efficacy and safety of the insulin glargine/lixisenatide fixed ratio     combination (FRC) to GLP-1 receptor agonist (GLP-1 RA) on top of metformin (with or without     pioglitazone, with or without SGLT2 inhibitor) in patients with type 2 diabetes.      To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension     period.   "
38055|NCT02787538|"     This proof-of-concept randomized trial evaluates the effectiveness of using an online     decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US     patients with rheumatoid arthritis.   "
38107|NCT02786849|"     The objective of this study will be to evaluate the effects of neuromuscular electrical     stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on     peripheral muscle strength, exercise capacity and muscle change and inflammation markers in     patients with chronic kidney disease (CKD).   "
46209|NCT02680756|"     The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron     (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent     maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).   "
38056|NCT02787525|"     The aim of the study is to compare intermedium-term clinical outcomes, including     thromboembolic events and bleeding complications between patients with non-valvular atrial     fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left     atrial closure).      A questionnaire is sent to the patients and if there is some information missing or unclear,     the investigators will contact the patient or the treating physicians to get the     missing/unclear information.      The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who     underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital     und Zurich University hospital) and a similar group of 500 patients with non-valvular AF     treated with oral anticoagulation (OAC).      In order to compare the two groups and reducing the bias due to confounding variables, a     propensity score matching will be performed.      Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy     and safety in comparison to lifelong oral anticoagulation in patients with non-valvular     atrial fibrillation.   "
38057|NCT02787512|"     Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is     still necessary in case of patients with cholangitis or very high level of bilirubin or     patients who are expected to receive delayed surgery.      The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable     metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in     patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.   "
38258|NCT02784886|"     The purpose of this study is to determine whether, in a high risk population (placenta     praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)),     the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly     increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine     if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful     biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography     and RMI).   "
38058|NCT02787499|"     The study design is an open-label, randomized controlled trial. The study will be conducted     at study sites in Uganda and South Africa. The study population will include HIV-infected     patients on first-line antiretroviral therapy with a recent viral load >1,000     copies/milliliter (or dried blood spot viral load >1,000 copies/milliliter). Eligible     participants will be randomized to the WHO-based standard of care for management of virologic     failure or immediate resistance testing to guide ART regimen decisions. The primary outcome     of interest will be viral suppression (<200 copies/mL) at 9 months after study enrollment,     and will be assessed using an intention to treat analysis, where missing or absent results     will be considered failures. Secondary outcomes of interest will be viral suppression below     the limit of assay detection, viral suppression on continuation of first-line (non-nucleoside     reverse transcriptase inhibitor [NNRTI]-based) therapy, drug resistance at study conclusion,     and mortality, among others. The overarching goal of this study is to determine whether     addition of routine resistance testing, to guide management of virologic failure and sustain     the successful completion of the HIV continuum of care, improves clinical outcomes and     reduces costs for patients with virologic failure on first-line therapy in sub-Saharan     Africa.   "
38059|NCT02787486|"     In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its     guidelines that now recommend physicians are ethically obligated to fully inform all pregnant     women that screening for fetal chromosomal abnormalities including biochemical screening     tests and invasive procedures such as CVS or amniocentesis is available, regardless of age.     Further, it is entirely up to the patient to decide whether or not she wishes to be screened     for fetal chromosomal abnormalities without judgment from the physician.      Noninvasive laboratory-developed tests (LDTs) that detect an abnormal amount of maternal and     fetal DNA in an expectant mother's blood sample (known as circulating cell-free DNA) are now     available. These LDTs have not been cleared or approved by the U.S. Food and Drug     Administration (FDA). Although LDTs to date have not been subject to U.S. FDA regulation,     certification of the laboratory is required under the Clinical Laboratory Improvement     Amendments (CLIA) to ensure the quality and validity of the test.      To sample collection study will obtain whole blood specimens from pregnant subjects to be     used for development of prenatal assays to assist in the screening for fetal genetic     abnormalities, infectious and other diseases, and blood group typing through detection of     circulating cell-free DNA extracted from maternal plasma.   "
38060|NCT02787473|"     To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer     treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by     docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also     planned.   "
38061|NCT02787460|"     The University of Florida offers relationship education programs named ELEVATE, for couples,     and Smart Steps, for couples in stepfamilies, in Citrus, Duval, Manatee, Palm Beach, and     Santa Rosa counties. Each workshop comprises 4 2.5-hour long sessions. The STREAMS evaluation     will examine whether text messages informed by behavioral insight theory can improve couples'     attendance at relationship skills education group sessions, and if so, which kinds of     messages are most effective   "
38062|NCT02787447|"     The investigators postulated that the exploitation of the pro-immunogenic effects of     radiotherapy with thymosin might result in abscopal responses among patients with metastatic     cancer. The research is designed to evaluate the efficacy and toxicity of patients treated     with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker     analysis in blood and tumor samples is also planned.   "
38063|NCT02787434|"     This is a multicenter study that involves research on screening for prostate cancer. This     study pilot tests a culturally appropriate decision aid (DA) for African American (AA) men     that will empower them to take part in decision-making regarding prostate cancer screening     (PCS). The Prostate Cancer Screening Preparation (PCSPrep) tool was designed with intend to     be delivered in primary care settings with attention to patient/provider interaction. Funding     for this study comes from the National Institute of Health/National Cancer Institute     (1R21CA178296).   "
38064|NCT02787421|"     In this study, the study team will investigate the validity and role of nasal dilator strips     (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the     pre-operative evaluation. The method involves placing the strip sequentially at the upper and     lower lateral cartilage and recording the location of the optimal airway based on patient's     subjective symptoms.      Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based     on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness     (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before     and after the operation and comparing these scores.The results will help determine the     effectiveness and predictive value of NDS in isolating the site of NVC.   "
38066|NCT02787395|"     Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent     dislocations. Following a first dislocation recurrence rates of up to 80% have been reported.     Many patients will seek medical assistance for reduction of the shoulder after each of these     recurrent dislocations. The investigators describe the results of reduction of anterior     glenohumeral dislocation using a modified self manipulated Milch technique that can be     performed by the patients themselves after simple guidance and demonstration. This method is     directed to patients who are not willing or cannot have surgical stabilization and may be in     a place where medical assistance is not available.   "
38067|NCT02787382|"     BACKGROUND      Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral     or autoimmune etiologies. Human CMV represents one of the leading causes of congenital     infections worldwide. There is limited data regarding the cardiac function of fetuses and     infants with CMV.      OBJECTIVE      To provide insight regarding the presence of myocardial involvement in fetuses and infants     with CMV infection.      PATIENTS & METHODS      Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period.     Patients will undergo detailed US examinations including dedicated neurosonography and     echocardiography starting at the time of the first referral and every 3-4 weeks until     delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy     women from the group will serve as controls   "
38068|NCT02787369|"     This research study is studying a drug called ACY-1215 in combination with ibrutinib or     idelalisib as a possible treatment for Relapsed or Refractory Chronic Lymphocyic Leukemia     (CLL).   "
38070|NCT02787330|"     The psychosocial effects of childhood cancer and its demanding medical treatment can affect     not only the ill child but the whole family, particularly siblings who are often overlooked     given the terrible circumstances these families face. Current evidence suggests that negative     long-term psychosocial effects of childhood cancer may be more severe in siblings than in the     child with cancer. Addressing these effects on siblings may benefit the child with cancer and     the entire family. Thus, early psychosocial preventive interventions are needed to foster     psychosocial adjustment in siblings and promote better quality of life for the entire family.     The immediate objective of this study is to address siblings' psychological distress by     assessing feasibility and efficacy of a manualized group intervention for siblings of     children with cancer (Siblings Coping Together, SibCT). A longer term objective is that the     evidence-based intervention could then be exported to other centres across Canada and     internationally. Additionally, the study results will identify biomedical, personal, familial     and social determinants of intervention outcomes that can guide clinical effort for those at     greatest risk. Finally, the overall aim of the project is to reduce psychological distress     and improve quality of life for siblings and families impacted by a cancer diagnosis and its     demanding treatment.   "
38071|NCT02787317|"     Prolonging infusions may decrease myocardial damage associated with bivalirudin use during     primary PCI. The investigators hypothesized that continuing the bivalirudin infusion     commenced during the procedure at the PCI recommended dose for 4 hours would prevent     myocardial damage.   "
38072|NCT02787304|"     The purpose of this study is to determine if the investigational treatment volixibat (SHP626)     is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).   "
38073|NCT02787291|"     To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR     ICD in an MRI environment.   "
38074|NCT02787278|"     The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1,     stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA     for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving     rtPA standard of care.   "
38075|NCT02787265|"     This is a prospective, multi-center, observational follow-up study observing the     effectiveness of high density spinal cord stimulation in patients with failed back surgery     syndrome patients with back and leg pain.   "
38076|NCT02787252|"     The purpose of this study is to observe the efficacy of stimulation on over all pain relief     as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal     Cord Stimulator (SCS) System for low back and/or leg pain.   "
38077|NCT02787239|"     Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the     Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in     Previously Untreated Subjects With CD20+ DLBCL   "
38078|NCT02787226|"     Total shoulder replacement is associated with considerable postoperative pain. A common     method to treat and prevent this post operative pain is to place a catheter in the neck and     leave it in place for up to 48 hours. The catheter delivers a medication called ropivacaine     directly to a major nerve near your shoulder. It is very effective at stopping pain. In     addition to preventing pain, it also prevents movement of the arm because it blocks the nerve     completely.      A newer method of treating post operative pain uses only a series of small injections into     the joint, skin, and muscles of the shoulder near the end of the surgery. This medication,     liposomal bupivacaine (Exparel), potentially provides analgesia for greater than 48 hrs but     does not require a catheter to remain in place and does not prevent patients from moving     their arm after surgery because it only blocks the pain portion of the nerve. Both methods     also frequently include the addition of oral and injected pain medicines like narcotics to     effectively control the pain.      Ropivacaine and Exparel both work well for postoperative pain after total shoulder     replacement. It is not known, however, if one method is superior in its ability to     treat/prevent pain or which method may have fewer side effects. The purpose of this study is     to randomly assign patients to receive either a catheter with ropivicaine or Exparel     injections to help determine if one method is superior in pain relief and if either method     has fewer side effects.   "
38152|NCT02786264|"     This study proposes to perform a descriptive analysis and pilot observational study looking     at the types and quantity of anesthetic agents used and their associations with outcomes     among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale New     Haven Hospital (YNHH).   "
38079|NCT02787213|"     Prospective multicenter observational study to further develop and validate a preterm birth     risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks     gestation. A single maternal peripheral blood sample will be collected for analysis. Data     related to potential risk factors for preterm birth will be obtained through maternal     interview and review of medical records. Subjects will be followed through the delivery     process to assess the course of pregnancy, labor, and to document any related maternal     complications. Neonatal outcomes will be gathered from the medical record for up to 28 days     of life or discharge, whichever occurs first.   "
38080|NCT02787200|"     This study aims to identify various time-variant and time-invariant components of EEG signals     using advanced signal processing techniques, such as machine learning. The investigators'     ultimate goal is to develop universal or customised brain-computer interface that are stable     across days or even years.   "
38081|NCT02787187|"     The purpose of this study is to compare outcomes of patients undergoing standard or extended     lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer   "
38133|NCT02786511|"     This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up     study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study,     that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B     cell maturation antigen (BCMA)-expressing multiple myeloma.      bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02     CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA     suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or     retreated if retreatment criteria are met) in parent clinical study. No investigational     treatment will be administered in this study.      After completing the parent study, eligible subjects will be followed for up to 15 years     after their last bb2121 infusion in the parent study.   "
38082|NCT02787174|"     Asthma is common in children and impacts their health. There are effective medications for     improving asthma, but some families have difficulty using medicines on a regular basis. This     study in the emergency department will improve medicine use for children 2-12 years-old with     asthma.      The investigators have used focus groups to get ideas from parents of children with asthma to     best design the intervention. This has helped us create the questions that are being used in     the intervention, and make the computer program appealing and acceptable to parents of     children with asthma.      The investigators will study the success of the intervention for children who receive it     compared to children who obtain routine emergency department care. Participants who receive     the intervention will complete a series of questions on a tablet computer. Questions will     guide creation of individualized education and advice to improve medication use for each     participant. The intervention will also allow for customized communication with each child's     primary care provider. The investigators will include educational boosters at 2 and 4 weeks     after the intervention delivered as chosen by the participant (email / text / RSS / mail).     Children in the routine asthma care arm will not receive the intervention, and instead will     receive routine discharge instructions by the emergency room doctors.      The investigators will compare the success of the intervention group to routine emergency     department care by using a device (DOSER CT) that measures daily administered doses of     medicine. Data from the DOSER CT will be collected monthly at home visits for three months.     The investigators will also measure health care use and quality-of-life for each child using     a survey at these home visits. The investigators believe that the intervention will improve     doses of medicine given, reduce unnecessary health care use, and improve children's quality     of life.   "
38083|NCT02787161|"     This is a randomized controlled clinical trial that will analyze the impact of high volume     online HDF in comparison to high-flux HD on measured physical activity.   "
38084|NCT02787148|"     Prospective studies indicate that patients with depression are at increased risk for     cardiovascular disease. Depression is also associated with a number of hemodynamic features,     which are known risk factors for cardiovascular morbidity such as increased heart rate,     reduced heart rate variability and blood pressure alterations. These hemodynamic alterations     may explain in part the increased cardiovascular risk associated with depression.      The purpose of this study is to determine whether treatment for depression with cognitive     behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors.     Hemodynamic assessments including heart rate, heart rate variability, continues blood     pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular     resistance will be conducted at baseline, after treatment and 2-month follow up. In addition,     circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood     pressure dipping and immunological biomarkers will be assessed. One-hundred patients with     Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long,     weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic     parameters without any intervention and the impact of repeated-measurement.   "
38085|NCT02787135|"     The aim of the present single-blind randomized-controlled therapy study is to assess the     efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion     regulation, improvement of self-esteem and sleep quality (CBTd-E).   "
38086|NCT02787122|"     The present study is a pilot single-blind randomized controlled therapy study. Its aim is to     assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses     on emotional processes that are involved in the formation and maintenance of delusions such     as emotional stability, emotion regulation and self-esteem.   "
38087|NCT02787109|"     The present trial is a phase I first in human, double blind, parallel and placebo controlled     trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant     system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in     the United Kingdom.      Subjects are randomly assigned to one of the following three treatment groups in a ratio of     3:3:1.      This trial consisted of 10 visits and 5 telephonic interviews   "
38088|NCT02787096|"     Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is     difficult. Standard MRI may be used but is of limited diagnostic value. The present study     aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI     for the diagnosis of ACL tear.   "
38089|NCT02787083|"     Bladder pain syndrome/interstitial cystitis (BPS/IC) is a difficult disease to both diagnose     and treat. It is defined as an unpleasant sensation (pain, pressure, or discomfort) perceived     to be related to the urinary bladder and associated with lower urinary tract symptoms for at     least 6 weeks duration, in the absence of infection or other identifiable causes. Pain is the     universal symptom, but many also experience symptoms of overactive bladder, possibly directly     related to the mechanism of pain. Treating pain may influence the symptom of urgency, if the     urge arises from a need to alleviate pain. In some patients whose pain improves with     treatment, troubling overactive bladder symptoms still remain. Beta-3 adrenergic agonists     have been found to decrease signaling of C-fibers in animal models. So, the investigators     hypothesize that mirabegron, which is FDA-approved for treatment of overactive bladder, would     also improve symptoms in patients with BPS/IC. As a selective beta-3 agonist, mirabegron acts     on the beta-3 receptors found in the bladder which mediate relaxation of the detrusor muscle.     It has been shown to significantly decrease the number or micturition episodes, urgency     episodes, and increased mean volume of urine voided per micturition. It also has a favorable     tolerability profile.   "
38176|NCT02785952|"     This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in     treating patients with stage IV squamous cell lung cancer that has come back after previous     treatment. This is a non-match sub-study that includes all screened patients not eligible     for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab,     may be able to shrink tumors. It is not yet known whether nivolumab works better with or     without ipilimumab in treating patients with squamous cell lung cancer.   "
38108|NCT02786836|"     The ALF-MBT protocol is for a multicenter, open label, non-randomized study to determine the     value of Breath Identification® (BreathID®) Acute Liver Failure 13C-Methacetin Breath Test     System in predicting the outcome of patients diagnosed with acute liver failure who meet     inclusion/exclusion criteria.      Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed     one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin     solution (test substrate).      The Breath Test will be performed on all patients upon admission into the study (Day 1) and     repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test     continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the     improvement or deterioration in liver metabolic function about improvement or deterioration     in liver metabolic function.      Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial)     to determine spontaneous survival, transplantation and occurrence of serious adverse events     since the patient's last study treatment.   "
38090|NCT02787070|"     Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an     acute infection. Recurrent infections can be associated with a febrile illness, a cumulative     risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after     both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we     have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day regimen.     In Papua a retrospective study found very low effectiveness for unsupervised treatment. If     true this has profound effects on treatment policy, suggesting that greater efforts are     needed to encourage adherence to treatment.      We propose a cluster randomized, controlled, open label trial to assess the effectiveness of     unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria.     Since the risk of recurrent P. vivax is high in patients with either P. vivax or P.     falciparum, both infections will be included in the study. The study will be conducted in     Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at     village health posts and provided with schizontocidal treatment plus primaquine radical cure     which will be either supervised or unsupervised depending on which cluster the clinic is in.     Participants will be followed up for 6 months and assessed in regular intervals for the     presence of patent and sub-patent malaria. The outcome of the study will contribute to an     improved treatment scheme for uncomplicated malaria in this area.   "
38091|NCT02787057|"     Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative     organisms was recommended as first-line regimen for the management of peritoneal dialysis     related peritonitis. Oral administration of quinolones can also achieve effective serum     concentrations, and is more convenient and economical. We conducted a pilot randomized     controlled study to compare the effects on peritonitis cure and relapsing rates between oral     moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.   "
38092|NCT02787044|"     INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce     cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine     in high-risk cardiovascular patients with a recent history of myocardial infarction or heart     failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three     additional influenza seasons. The primary endpoint will be a composite of all-cause mortality     or cardiopulmonary hospitalization.   "
38093|NCT02787031|"     The investigators will use health administrative data to examine the variation of anesthesia     type for hip fracture surgery, as well as sources of variation and predictors of variation.   "
38094|NCT02787018|"     The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as     an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of     block and duration of analgesia, so that the investigators can choose the better adjuvant for     the investigators routine practice of regional anesthesia.   "
38095|NCT02787005|"     This is a study of pembrolizumab (MK-3475) in participants with metastatic     castration-resistant prostate cancer (mCRPC). Participants will be enrolled into one of five     cohorts: Cohort 1 (participants with programmed cell death ligand 1 [PD-L1]-positive,     measurable disease), Cohort 2 (participants with PD-L1 negative, measurable disease), Cohort     3 (participants with bone-metastases and non-measurable disease) post-chemotherapy, Cohort 4     (participants with Response Evaluation Criteria in Solid Tumors version 1.1- [RECIST     1.1]-measureable disease) and Cohort 5 (participants with bone metastases only or     bone-predominant disease) pre-chemotherapy.   "
38096|NCT02786992|"     This prospective randomized double-blind clinical trial will be conducted at Ain-Shams     University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment     cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol     following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100     ug carbetocin intravenous after cord clamping.   "
38097|NCT02786979|"     The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin     for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.   "
38098|NCT02786966|"     Each year, half a million patients with a potential neck (c-spine) injury are transported to     Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck     bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries     usually occur at the time of initial trauma and not during transport to the ED. Currently,     paramedics transport all trauma victims (with or without an injury) by ambulance using a     backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until     an ED bed is made available or until x-rays are completed. Importantly, long immobilization     is often unnecessary, it causes patient discomfort and pain, decreases community access to     paramedics, contributes to ED crowding, and is very costly.      The investigators developed the Canadian C-Spine Rule (CCR) for alert and stable trauma     patients. This decision rule helps ED physicians and triage nurses to safely and selectively     remove immobilization, without x-rays and missed injury.      The investigators will evaluate the possibility and benefits of allowing paramedics to use     the CCR in the field in 12 new communities from across Ontario. Patients have suggested the     investigators include measures of pain and discomfort from being immobilized during transport     as important patient-centred outcomes. The investigators will also measure the impact on the     ED, and how much money could be saved if more paramedics were allowed to use the CCR. The     investigators will also assess if sex, age, language barriers, or living far from the     hospital (long transport time) will affect the outcomes of the study.   "
38118|NCT02786706|"     Optic Nerve Ultrasound (ONUS) is a promising non-invasive tool for the detection of raised     Intracranial Pressure (ICP). Variability in the optimal Optic Nerve Sheath Diameter (ONSD)     threshold corresponding to elevated ICP in multiple studies limits the value of ONUS in     clinical practice. The investigators goal is to develop and validate an automated image     analysis algorithm for standardization of ONSD measurement from ultrasound videos. Patients     with acute brain injury requiring invasive ICP monitoring will undergo bedside ONUS, with     blinded ONSD measurement by an expert investigator. The image analysis algorithm will then be     used to measure ONSD and accuracy determined compared to the reference standard expert     measurement.   "
39179|NCT02772822|"     The primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus     Rituximab plus CHOP in untreated CD20-positive DLBCL Patients.      The secondary objective of the study is to evaluate the safety of SCT400 plus CHOP, as well     as the presence of human anti-chimeric antibodies (HACA).   "
38099|NCT02786953|"     Adolescents with type 1 diabetes (T1D) are at increased risk for problems with adherence and     suboptimal glycemic control, and novel approaches are needed to improve outcomes in this     high-risk population. The majority of adolescents obtain insufficient sleep (defined as <8     hours/night), and sleep disturbance has been significantly associated with poorer adherence     and predicted greater problems with quality of life and worse glycemic control. Yet, no     interventions have addressed sleep in youth with T1D. Working from a biopsychosocial and     contextual model of sleep, the investigators propose to tailor a sleep-promoting intervention     to meet the needs of adolescents with T1D by conducting interviews with to identify the     barriers and facilitators to adequate sleep specific to this population. The sleep-promoting     intervention will be developed and tested, building on successful sleep interventions in     other populations, including components such as limiting caffeine, establishing a media     curfew, and positive bedtime routines, while addressing the needs unique to adolescents with     T1D, such as fear of hypoglycemia. The study will be conducted by a multidisciplinary team,     consisting of Sarah Jaser, PhD, a pediatric psychologist, and two co-investigators, Beth     Malow, MD, MS, a neurologist with specialty in sleep medicine, and Jill Simmons, MD, a     pediatric endocrinologist. Sleep is a potentially modifiable risk factor that may have both a     physiological and behavioral impact on diabetes outcomes. Given the strong associations     between sleep and diabetes outcomes in the preliminary data, and recent evidence from sleep     restriction studies indicating the impact of insufficient sleep on insulin sensitivity,     behavior, and mood, there is reason to believe that a sleep-promoting intervention has the     potential to improve outcomes in adolescents with T1D indirectly by improving adherence and     directly through its effect on metabolic function. Therefore, the proposed study offers a     novel approach to improve adherence, quality of life, and glycemic control in adolescents     with T1D.   "
38100|NCT02786940|"     2-3% of emergency department (ED) syncope patients suffer arrhythmia/death within 30-days of     disposition (either as inpatient or at home) and the investigators recently developed the     Canadian Syncope Arrhythmia Risk Score (CSARS) to predict these outcomes. Currently, only     holter monitoring is used and is applied a few days later. New and innovative remote     (out-of-hospital) external cardiac monitoring technology has made prolonged monitoring     possible with live automatic and patient triggered cardiac rhythm transmission to a central     monitoring station.      Objective: To conduct a multicenter two-arm open label RCT among higher-risk (CSARS score≥3)     ED syncope patients discharged home for comparing the diagnostic yield (detection of serious     arrhythmias that required treatment or exclusion of arrhythmia) at the end of 15-days between     a 15-day event monitor (intervention) and usual care (48-hour holter with patients seeking     care after 48-hours based on symptoms) at 10 Canadian EDs.      Methods: Cardiophone (live monitor) will be used for the intervention arm and the Mobile     Cardiac Telemetry (MCT) device will be used for the control arm and both devices applied     prior to ED discharge. MCT will function as a holter for first 48-hours and then as an event     recorder (days 3-15) for arrhythmia surveillance. After written informed consent, patients     will be randomized 1:1 with allocation concealed by web-based randomization and stratified     based on the total CSARS scores. All patients will be linked to a study cardiologist and will     have follow-up after 15-days. If serious arrhythmias are detected by Cardiophone, the patient     will be transported to ED and for non-serious arrhythmias, an interim report sent to the     study cardiologist for follow-up. All monitoring reports will be sent to the cardiologist     within 24-hours of completion. Data collection: patient demographics, medical history, score     predictors, device data (failure, false alarms, duration worn), patient symptoms and comfort.     Primary outcome will be diagnostic yield at 15-days in the two study arms and primary     analysis will compare the diagnostic yield by intention to treat principle controlling for     the stratification factor. Sample Size: 300 patients per arm (600 total) to detect a 10%     difference in diagnostic yield between the arms.      Impact: Our study will increase early identification of patients with serious underlying     arrhythmia by combining the CSARS risk tool with innovative remote monitoring technology.   "
38101|NCT02786927|"     This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in     subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific     preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER     DPI. The primary objective of this study is to evaluate whether more subjects with COPD     prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take     medication.      All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding     treatment periods based on the randomisation scheme, and at the end of 2 periods, complete     the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily     for 5-9 days in each treatment period.      This study will be placebo-only, and neither inhaler will contain active treatment. Subjects     will continue their current COPD medication(s) as prescribed, and will follow up with their     regular physician for their COPD healthcare during the study.      Approximately 211 subjects will be enrolled in the study.      ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark     of Boehringer Ingelheim International GmbH.   "
38102|NCT02786914|"     Patients with suspected tree-nut or sesame allergy based on sensitization on skin-prick tests     (SPT), will be assessed for allergy using component analysis and basophil activation test     (BAT) and entered into oral immunotherapy (OIT). Component analysis and BAT will be repeated     after completion of OIT.   "
38104|NCT02786888|"     Early ambulation after knee replacement surgery is made possible in large part by providing     safe and effective pain control. Peripheral nerve blocks are increasingly used for     postoperative analgesia since they can provide excellent pain relief and minimize the need     for opioid analgesics.      Ultrasound guided adductor canal block (ACB) was first reported in 2009 by anesthesiologists     at the University of Utah. This block is unique in that it spares motor function in the lower     extremity. Since 2009, a number of publications have described the successful use of ACB for     pain management after total knee arthroplasty (TKA), anterior cruciate ligament (ACL)     reconstruction, and other procedures of the knee. As a component of multi-modal analgesia,     ACB can provide effective postoperative pain control and facilitate early hospital discharge.      Although it is widely utilized, the ACB block can be technically difficult to perform since     it requires injection in immediate proximity to the femoral artery and vein. In patients with     a large thigh circumference, ultrasound can be challenging since the femoral vessels are     deeper and more difficult to visualize. This presents the possibility of vessel trauma and/or     intravascular injection of local anesthetic.      The investigators have implemented a new technique for performing the ACB. This block is     performed using a 20G fenestrated needle. The needle is FDA approved for peripheral nerve     block. It has an occluded tip with 8 side ports on alternating sides of the distal 2cm.     Injection through the fenestrated needle produces effective distribution of local anesthetic     to nerves of the adductor canal without immediate proximity to the femoral artery and vein.     The ultrasound landmarks used to perform ACB with the fenestrated needle are readily visible     even in patients with very large thigh circumference.      In summary, early experience with the US guided ACB block performed with a fenestrated block     needle suggests that it is technically easier and potentially safer to perform than blocks     performed with a conventional needle.      This study should be performed prospectively in order to ensure accurate data comparing the     two needles. A retrospective review of blocks performed using a conventional needle would not     provide accurate data with respect to the number of attempts, time required to perform the     blocks or the resulting sensory changes after performing the nerve block.   "
38105|NCT02786875|"     The purpose of this study is to reduce breast cancer recurrence and hence increase     disease-free survival through a lifestyle program that includes a low glycemic diet, physical     activity and vitamin D supplementation in women with breast cancer living in a Mediterranean     country.   "
38106|NCT02786862|"     Adequate blood oxygenation and ventilation/perfusion matching should be the main goal of     anaesthetic and intensive care management. At present, the sole method of improving gas     exchange restricted by ventilation/perfusion mismatching is independent ventilation with two     ventilators. Recently, however, a unique device has been developed, enabling ventilation of     independent lungs in 1:1, 2:1, 3:1, and 5:1 proportions. The main goal of the study was to     evaluate the device's utility, precision and impact on biomechanical lung parameters during     thoracic surgery under general anaesthesia with double lumen tube intubation. Secondly- to     measure the gas distribution in supine and lateral decubitus position.   "
38134|NCT02786498|"     The objective is to determine the effect of vitamin D3 supplementation on fracture healing at     3 months.   "
38111|NCT02786797|"     The purpose of this study is to evaluate MBSR(BC), an intensive meditation-based stress     reduction intervention, in order to determine its efficacy in improving cognitive functioning     among breast cancer survivors. The study will employ a three group randomized design that     will (1) evaluate the extent to which MBSR(BC) compared to the Breast Cancer-Education     Support (BCES) program or Usual Care (UC) improves cognitive functioning among breast cancer     survivors off treatment; (2) determine if improvements in cognitive functioning achieved from     MBSR(BC) are mediated through increased mindfulness and decreased rumination and stress; (3)     evaluate genetic variants as moderators of MBSR(BC) on improvements in CI; and (4) determine     the impact of MBSR(BC) on healthcare utilization and costs, in addition it will be delivered     to a sub-group in Spanish. If shown to be efficacious, the possibility exists of utilizing     this intervention in other types of cancers as well as non-cancer health-related disorders in     order to minimize the morbidity experienced by these populations.   "
38112|NCT02786784|"     Patellofemoral pain (PFP) is the most diagnosed condition in individuals with knee     complaints. Studies revealed that one third of individuals with PFP suffer from persistent     complaints, indicating that current treatments fail to prevent the chronicity of symptoms.     Considering that current treatment-strategies of patients with PFP seem to be unable to avoid     the development of chronic symptoms, the question arises if the underlying factors of PFP are     understood sufficiently. Current research focuses predominantly on muscle strength assessment     by means of a maximum voluntary contraction (MVC), even though, weakness might not only be     caused by a reduced voluntary contraction but also by an involuntary ability to contract the     muscle fully, which is named arthrogenous muscular inhibition (AMI). Although AMI has been     proven to be present in a wide range of knee joint pathologies to date it remains unclear     whether patients with PFP are weak or inhibited. It remains also unclear if there exists a     causal link between AMI and biomechanical alterations.      Previous studies investigated the influence of exercise treatment on muscular strength,     function and pain. However, to date no study investigated the influence of the currently     recommended exercise treatment on AMI. Thus, the analysis of the effect of a 6 week exercise     treatment might yield further insights if a specific exercise treatment can reduce AMI,     improve functional performance and reduce pain.      Methods: The investigators will invite 40 participants with PFP and 40 healthy controls to     take part in the study. As a basis investigation kinematic, kinetic measures, and surface     electromyographic (sEMG) of 4 lower limb muscles will be taken during functional tasks.     Muscle strength and AMI of the quadriceps, muscle flexibility, and a posture assessment of     the patella as well as the foot will be carried out. All participants with PFP will then     receive a 6 week exercise programme to follow. After six weeks, the participants with PFP     will attend the Salford university, where they will be reassessed.      Expected outcomes: The study will investigate if AMI is present in participants with PFP and     if AMI is directly linked to functional performance. In addition this study will investigate     if a specific exercise treatment can reduce AMI and improve functional performance.   "
38113|NCT02786771|"     The goal of this study is to evaluate the effectiveness of Spire and Muse on stress     management. The study will be implemented as a 2-arm randomized controlled pilot study to     assess the effect of either device on stress management from the end of baseline to closeout.   "
38114|NCT02786758|"     This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV)     in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay     and bisexual men by treating prevalent infection, thereby reducing new primary infections and     re-infection.   "
38115|NCT02786745|"     To find out the safety and effectiveness of dapsone.   "
38116|NCT02786732|"     The purpose of the study is to evaluate the efficacy and safety of Induction and Maintenance     Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to     severe plaque psoriasis.   "
38117|NCT02786719|"     Patients will be asked to participate in this study because patients have been diagnosed with     high-risk neuroblastoma, a common childhood cancer which has aggressive features. If left     untreated, high-risk neuroblastoma is fatal. Children with high-risk neuroblastoma often     respond to current available treatments, but there is a high risk that the cancer will     return.      This study will test the safety of giving standard induction treatment for high-risk     neuroblastoma without one of the drugs commonly used to prevent side effects. Current     treatment for high-risk neuroblastoma includes anti-cancer drugs (chemotherapy), surgery,     radiation therapy and high-dose chemotherapy with hematopoietic stem cell rescue. Treatment     takes about one year to complete and occurs in 3 phases: induction, consolidation, and     maintenance. This study is limited to the induction phase of treatment.      Induction therapy includes six chemotherapy drugs given in different combinations every 3     weeks for a total of 6 courses. For the past decade, induction chemotherapy has been followed     by a drug called granulocyte colony stimulating factor (G-CSF, filgrastim, peg-filgrastim,     Neupogen, or Neulasta) to prevent side effects from the chemotherapy. G-CSF is routinely     given to patients with high risk neuroblastoma after chemotherapy to stimulate white blood     cell production and shorten the time period when the absolute neutrophil count (ANC), a type     of white blood cell, is low after chemotherapy. G-CSF is known to shorten the period of low     ANC by approximately 3 days. When the ANC is lowest, a patient is most at risk of getting a     bacterial infection.      Recent lab experiments in mice have shown that neuroblastoma tumor cells may respond to G-CSF     by growing faster and metastasizing (spreading to other parts of the body). There have been     no clinical trials comparing the survival of children with high risk neuroblastoma with or     without G-CSF. This clinical trial is the first step towards giving induction chemotherapy     with less G-CSF.      The goal of this study is to determine if it is safe to give induction chemotherapy to     children with neuroblastoma without giving G-CSF routinely.   "
46257|NCT02680132|"     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release     Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were     separated by a washout period of 7 days.   "
38119|NCT02786693|"     Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are     two frequent causes of hospitalization or consultation in infectious disease unit and     internal medicine.      There are many etiologies, in four categories: infections, auto-immune disease, cancer and     miscellaneous causes. Currently there is no specifics recommendations to follow a diagnosis     way of FUO and SII.      Purpose: Evaluation of clinical practices in the diagnosis of fever and biologic inflammatory     syndrome of unknown origin, in two units of the University Grenoble Hospital.   "
38135|NCT02786485|"     This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor     BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with     recurrent disease minimal residual disease (MRD) post-allogeneic transplant.   "
38136|NCT02786472|"     The purpose of this randomized intervention pilot is to evaluate the relative efficacy of     bystander training elements (delivery mode and integration of substance abuse prevention)     among cohorts of incoming undergraduates at the University of Kentucky, a nationally     recognized leader in addressing sexual violence through bystander intervention programming.     Consenting students will be randomized to one of the following training conditions:        1. In-person Green Dot Intensive Bystander-based Sexual Violence Prevention Training          (GreenDot);        2. In-person Green Dot Intensive Bystander Training combined with Substance Abuse          Prevention Training;        3. Online Bystander-based Sexual Violence Prevention Training (Haven), and;        4. Online Substance Abuse Training (AlcoholEdu).   "
38259|NCT02784873|"     The purpose of the trial is to compare the effects of high intensity interval training (HIIT)     with usual care - moderate intensity steady state training (MISS) - in UK cardiac     rehabilitation (CR) programmes.   "
38120|NCT02786680|"     A large body of evidence points to impairment in the decoding of emotional stimuli in     Parkinson's disease (PD). These changes seem to be related to dysfunction of the     mesocorticolimbic projections leading to dysfunction of the limbic cortico-subcortical loop     that, throughout the basal ganglia, projects to limbic cortical regions such as the anterior     cingulate cortex and the orbitofrontal cortex, which are known to be involved in emotional     processing. Thus, presumably the occurrence of non-motor psychic symptoms and fluctuations in     PD would also rely on the degeneration of this circuitry. Dopamine modulation of emotions has     been frequently reported both in healthy subjects or PD patients, but the effect of     subthalamic nucleus deep brain stimulation (STN-DBS) over mood symptoms is more controversial     and there is still a paucity of data demonstrating its role in emotional processing. The     objective of our study is to assess and compare the behavioral and electrophysiological     effects of both dopamine and STN-DBS in PD during emotional processing. To do so, the     Emotional Stroop task, a version of the classical Stroop test developed to investigate     inhibition of emotional interference, will be performed by STN-DBS PD patients in four     different treatment conditions while high resolution electroencephalographic cortical mapping     is conducted. Using this approach, the investigators expect to better separate the mechanisms     of psychic features related to either disease, dopaminergic treatment, subthalamic     stimulation or the association of both, with the final aim of optimizing the clinical     management of PD.   "
38121|NCT02786667|"     Clinical description and pathophysiological study of recently diagnosed untreated patients     with Parkinson's Disease.      Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson     disease: A controlled, randomized, double blind study.   "
38122|NCT02786654|"     The aim of the study is to investigate the association between the use of β blockers and     mortality among hospital survivors of acute myocardial infarction without heart failure.   "
38123|NCT02786641|"     The investigators aim to evaluate the efficiency and toxicities of induction chemotherapy of     docetaxel, cisplatin and xeloda in nomogram-predicted high risk locoregionally advanced     nasopharyngeal carcinoma.   "
38124|NCT02786628|"     The primary objective of this study is to assess the feasibility of a multi-institutional     study that collects cardiopulmonary exercise testing and 6 minute walk distance performance     testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient     generated health data (wearable activity monitors and patient reported outcomes) for the     subsequent month. In addition to demonstrating feasibility, the study looks to generate     preliminary data that supports the capacity of physical performance testing and     patient-generated health data to complement clinician-rated performance status in patients     receiving chemotherapy.   "
38125|NCT02786615|"     This study addresses the disproportionate representation of men who have sex with men (MSM)     in the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic     in Kazakhstan, a country that has seen some of the largest growth in new HIV infections since     the turn of the century. Using a stepped wedge trial across 4 cities in Kazakhstan, the     proposed study will test a strategic and innovative social network-based intervention for MSM     who use drugs in Kazakhstan as a strategy to increase their numbers in the HIV continuum of     care as well as services that address issues that co-occur with HIV, including drug abuse,     Hepatitis C Virus (HCV) infection, and other sexually transmitted infections.   "
38126|NCT02786602|"     Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the     third most common cancer in incidence and mortality in France. The vast majority of these     cancers are adenocarcinomas that arise sporadically and develop from precursor lesions:     adenoma. All CRC with the same disease stage do not have the same prognosis. Various     parameters have been identified as factors influencing the prognosis and allows adjustment of     the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor     or the mucinous adenocarcinoma subtype. At the molecular level, the presence of     microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF     mutation is an independent poor prognostic factor.      The different molecular pathways of colonic carcinogenesis are the chromosomal instability     pathway, the microsatellite instability pathway inducing errors in DNA mismatch repair and     the CpG Island Methylator Phenotype (CIMP). The hypermethylation of CpG islands of genes     promoters leads to an over or most frequently under gene expression. CIMP is observed in near     15% of CRC and is associated with specific clinical and pathological features: older     patients, female predominance, right colonic involvement, poorly differentiated or mucinous     adenocarcinomas. From a molecular point of view, the high CIMP phenotype is strongly     associated with the presence of BRAFV600E mutation, the absence of RAS mutation and the     presence of microsatellite instability. The prognostic value of CIMP is actually     controversial. A recent meta-analysis found that the CIMP phenotype was associated with a     poor prognosis. Methylation of some genes promoters as CDKN2A is associated with a poor     prognosis.      LRP-1 (low density lipoprotein receptor-related protein 1) is a multifunctional endocytic     receptor that belongs to the LDL receptors the family. It mediates the clearance of many     extracellular enzymes involved in the spread of cancer cells: metalloproteinases and serine     proteinases. Decrease of LRP-1 activity or loss of LRP-1 expression correlates with increased     aggressiveness of cancer cells in certain types of cancer. The expression of LRP-1 has almost     never been studied in CRC. Only one immunohistochemical study of LRP-1 protein expression in     colonic adenocarcinoma has been published to date. This study shows that tumor cells express     LRP-1, but in nearly half the cases, weaker than in normal cells colic. The mechanisms     involved in the decrease of expression are not known.      An epigenetic mechanism might be involved as hypermethylation of the of LRP-1 gene promoter,     especially as the promoter of this gene is rich in CpG islands (methylation targets).     Clinical and prognostic significance of the LRP-1 gene expression and promoter methylation is     actually unknown.   "
38127|NCT02786589|"     The objective of this study is to evaluate the safety and the effectiveness of Plasmodium     immunotherapy (blood-stage infection of Plasmodium vivax) for advanced non-small cell lung     cancer   "
38128|NCT02786576|"     This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis     Suppurativa (HS) patients in the real world setting. The objectives of this study are to     estimate the effectiveness of adalimumab treatment on disease severity, to estimate the     impact of adalimumab treatment on patients' quality of life, psychological effect, work     productivity and healthcare resource utilization and to describe treatment practices over the     study period.   "
38129|NCT02786563|"     Prospective, post-marketing, multi-center, open-label study to explore if the initiation of     adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US) score     using 36-joint plus 4-tendon scoring system, and validate the applicability of different     simplified US joint scoring systems.   "
38131|NCT02786537|"     Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to     learn whether they work equally well under real-world conditions. Phase 2 of this study will     begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments.     Patients receiving HCV therapy in community and academic clinics will be offered the     opportunity to consent to be randomly assigned to one of three regimens and then observed for     outcomes. Once randomized, all medical care, laboratory testing, and any disease or side     effect management will be assumed by usual care conditions, and patient-reported outcomes     will be collected outside clinic in keeping with pragmatic design principles.   "
38137|NCT02786459|"     An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal     probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent     (ProstaScintÂ®; as a surrogate marker for prostate cancer) in patients who have undergone a     radical prostatectomy for their disease, patients with multiple negative prostate biopsies     and patients with known primary prostate cancer. Developed by Hybridyne Imaging Technologies,     Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera. It is     the same size as a trans-rectal ultrasound (TRUS), currently used for prostate biopsy     guidance. Men with multiple positive biopsies will be considered controls. Prostate cancer     sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, MRI and SPECT/CT.     The investigators hypothesize that it will be safe and feasible to utilize a rectal probe     scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScintÂ®, thus identifying and     localizing the tumour sites within the prostate and surrounding areas.   "
38138|NCT02786446|"     We want to compare the effect of lignocaine 2 % gel, Naproxen sodium and their combination on     the pain control during extracorporial shock wave lithotripsy for renal stones.   "
38139|NCT02786433|"     Introduction: Parkinson's disease (PD) is a progressive neurodegenerative disorder of     dopaminergic neurons that can cause some mobility limitations and it has association with     quality of life (QOL) in patients with PD. Virtual reality (VR) has been used to treat of     these patients Objective: Evaluate the functional capacity and QOL of individuals with PD     using VR with X-Box Kinect®. Methods: Were selected 20 individuals classified as stages 1-3,     aged 50-75 years. They were divided by lot into two groups (control and experimental) with     ten patients in each. The group (CG) treated with exercises (conventional therapy) during     five-week, with two sessions per week lasting 60 minutes, while the experimental group (EG)     spent half the time with conventional physical therapy and other half of time in virtual     rehabilitation (VR). Subjects were evaluated before and after treatment using the following     scales: Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire .   "
38140|NCT02786420|"     How environmental pollution contributes to poor pregnancy outcome is poorly understood. The     first trimester of pregnancy is a particularly vulnerable time period for the developing     fetus and a mother's exposure to air pollution may alter the way that the placenta is     established and how it functions throughout the rest of pregnancy. This project aims to     expand and develop new MRI technologies to assess real-time placental structure and function     as pregnancy develops from the first to the third trimester so that early detection,     prevention strategies, and early treatment of placental dysfunction as a result of pollution     exposures may be developed.   "
38161|NCT02786147|"     The purpose of this study is to identify the most effective means of follow-up for women who     screen positive on B-RST (Breast Cancer Genetics Referral Screening Tool) applied in the     standard clinical setting of mammography, to maximize the number who are referred to and     receive cancer genetic counseling services. The clinical utility of B-RST 3.0 will also be     evaluated by determining the number seen who are appropriate for genetic testing, undergo     genetic testing and are found to carry a hereditary cancer gene mutations with medical     management implications for the patient and family. The long-term goal is to reduce the     morbidity and mortality associated with hereditary causes of breast and ovarian cancer among     patients seen in the Emory/Winship system.   "
39718|NCT02765737|"     Multicenter, prospective, randomized, controlled feasibility trial to determine the safety     and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as     compared to Control alone for the treatment of second degree burns as assessed by time to     healing and scarring   "
38141|NCT02786407|"     This is a multicenter, double-blind, randomized, placebo-controlled study designed to     evaluate the efficacy and safety of Botulinus Toxin Type A for Injection (HengLi®) in     patients with overactive bladder (OAB) . Approximately 216 subjects will be enrolled.     Subjects will be randomized 2:1 to receive intradetrusor injection of Botulinus Toxin Type A     for Injection (HengLi®) 100 U or placebo. The study contains two parts: core double-blinded     phase and extension phase. In the core double-blinded phase, eligible subjects must attend     three study visits posttreatment 12 weeks. During the extension phase, subjects must also     attend three study visits (12 weeks). The primary efficacy variables is the change from     baseline in the daily average frequency of micturition at week 6 after the first treatment.A     3-day paper bladder diary will be used before each study visits (screening period, the second     week, the sixth week, the twelfth week, the fourteenth week, the eighteenth week and the     twenty fourth week ) to collect all OAB symptoms (episodes of urgency, incontinence,     micturition and nocturia) and volume per voidSafety parameters will also be measured,     including adverse events, vital signs (pulse and blood pressure) and clinical laboratory     tests (haematology, serum chemistry and urinanalysis).   "
38142|NCT02786394|"     The purpose of this study is to test feasibility for the delivery and perceptions of a     lifestyle model for middle-aged and older adults by involving participants in its     development. The goal of the program is to reduce sedentary behaviour, increase physical     activity, and increase strength and balance. An optional walking program will be run in     parallel to emphasize the importance of moving more. Participants will be asked to fill out     questionnaires on course delivery, content and effect throughout the program and 2-3 recorded     interviews throughout the study. We will collect measurements of physical performance before     and after the program.   "
38143|NCT02786381|"     This clinical study will collect fresh samples and perform laboratory testing on fresh and     archived samples as described in the protocol.   "
38155|NCT02786225|"     Perinatal outcomes in the US rank behind most other developed countries even though women in     the US utilize more maternity services. Current approaches to consultation and collaboration     among perinatal care providers, including nurse-midwives, obstetricians, and perinatologists,     fragment care resulting in communication errors and maternal dissatisfaction. The CARE study     will test an innovative interdisciplinary consult visit to improve communication, teamwork,     maternal satisfaction, and perinatal outcomes.   "
38260|NCT02784860|"     This study assesses the benefits of continuous intravenous lidocaine administration during     sedation for colonoscopy.      Sedation will consist of propofol infusion titrated to provide adequate working conditions to     the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine     infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same     volume of placebo (normal saline)   "
38144|NCT02786368|"     This project is a delayed pragmatic delayed-intervention cluster randomized control study in     a subset of households (n=600) enrolled in a larger scale up program of enhanced homestead     food production (EHFP) in Cambodia. The trial is designed to evaluate the impact of EHFP     (home gardens only; home garden and fishponds; home gardens and poultry) versus control group     on dietary intake of women and youngest child, household food security, income, and     production throughout the agricultural cycle. Following administration of the baseline survey     300 households will be randomized to the EHFP package of their choosing (Intervention Group)     for two years. The other 300 households will not receive any intervention during the first     year and will act as the control group; data will be collected monthly on production and     income generated from gardening (and other homestead food production activities) and at two     points throughout the year 24-hour dietary recall data will be collected from the women head     of the household (aged 15-49y) and the youngest child between the ages of 6 - 59 months.     After one year, the control group will be offered the intervention (EHFP package of their     choice) fully subsidized and the project team will collect identical data on intervention     group for one year as described for the control group.   "
38145|NCT02786355|"     We will conduct this study to show that it is possible to ventilate effectively through a     Frova bougie and an Ambu® bag.   "
38146|NCT02786342|"     Sorafenib represents the standard care for advanced hepatocellular carcinoma (HCC). However,     molecular predictors of sorafenib efficacy have not yet been identified.      The primary aim of the study is to validate the prognostic or predictive role of eNOS,Ang2,     HIF-1, VEGF and VEGFR polymorphisms in relation to clinical outcome (progression-free     survival, PFS) of HCC patients treated with sorafenib.   "
38147|NCT02786329|"     Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without     lidocaine on postoperative short and long term outcome in patients with colorectal cancer     undergoing surgery.      As short term endpoints postoperative pain and opioid consumption, resumption of bowel     function, PONV, LOS will be registered.      Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer     recurrences incidence and mortality.   "
38148|NCT02786316|"     Low back pain is a common disorder, occurring worldwide in both males and females in all age     groups1. The prevalence is higher in females and the incidence peaks between 30 and 65 years.     It is currently the most frequent musculoskeletal cause of functional disability and it has a     major socio-economic impact on today's society. Although a small percentage of persons with     low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with     low back pain present with symptoms of nonspecific origin. A part of these symptoms are only     of short duration, but 23% of all people will develop nonspecific chronic low back pain     (NSCLBP).      Exercise therapy (ET) is currently an important component in the treatment of NSCLBP.     Previous studies analysed the effects of various modes of exercise therapy, such as motor     control therapy, core stability training and aerobic conditioning training. However, therapy     outcomes can be low, and guidelines in favour of using a specific program are contradictory.     It thus still remains unclear which therapy modality is best suited. Furthermore, no     recommendations are available about optimal training intensities during rehabilitation of     persons with NSCLBP.      Since as well aerobic as muscular deconditioning are apparent in persons with chronic low     back pain and improvements in overall physical fitness can affect therapy outcomes in this     population, ET specifically focussing on physical fitness can be advocated for NSCLBP     rehabilitation. High Intensity Training (HIT), has been promoted as an effective and     efficient training method for improving physical fitness and health related parameters in     healthy persons. Also, HIT resulted in successful reconditioning and improvement of     functional and disease related outcomes in persons with other chronic diseases such as     multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies     showed promising results for the effect of HIT on low back pain such as high intensity     isolated, evidence is still scarce and study results are unclear because of methodological     shortcomings.To evaluate HIT for the rehabilitation of persons with NSCLBP, a therapy program     was developed consisting of high intensity interval cardio and high load whole body strength     training.      The aim of this pilot study is 1) to evaluate the feasibility of a HIT program for the     rehabilitation of persons with NSCLBP, and 2) to evaluate the effects of a HIT program on     disease related outcomes and physical fitness compared to a conventional rehabilitation     program in persons with NSCLBP.   "
38149|NCT02786303|"     The diagnosis and the follow-up of neuroendocrine tumors can be difficult to assess,     especially in the detection of metastasis as they can grow in different organs such as liver,     lungs, bones or lymph nodes. Nowadays, the diagnosis is made with two main imaging techniques     which are the thoraco-abdomino-pelvic CT-scan and a scintigraphic method (Octreoscan and     sometimes a TEP-scan). The use of a whole-body MRI is more and more often used for the     detection and evaluation of tumors and metastases; therefore, it could be used for     neuroendocrine tumors. The MRI would allow to replace the two imaging techniques and to avoid     the use of irradiation but also to have a better detection of metastases. This purpose of the     study was to evaluate this statement by assessing the consistency between the routine     techniques and the MRI and finally to update the recommendation if the study is positive.   "
38150|NCT02786290|"     This is a First in Human study to assess the feasibility, safety and effectiveness of the     Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia     (BPH).   "
38153|NCT02786251|"     The recent discovery of functional brown adipose tissue (BAT) in humans has led to a paradigm     shift in adipose tissue biology; it is now believed that adipocytes may play a significant     role in regulating substrate metabolism. Given that the resurgence in the interest in human     BAT is still in its infancy, a number of fundamental questions pertaining to the role of BAT     in human physiology remain unanswered. One area of particular importance, but poorly     understood, is the potential effect of BAT on triglyceride (TG) metabolism. Data from a     series of studies have found that BAT is inversely associated with adiposity, high blood     lipids, and fatty liver in people. However, the role of BAT in the regulation of TG     metabolism in people is not known. The overall goal of this study is to determine the     physiological importance of the human BAT in TG metabolism. To this end, we are planning to     study forty overweight/obese women with high amounts of BAT (BAT+, n=20) and with no/minimal     BAT (BAT-, n=20) both under thermoneutrality and mild cold exposure (~2 weeks apart). The     investigators hypothesize that BAT+ subjects will demonstrate greater plasma very low density     lipoprotein-triglycerides (VLDL-TG) clearance rate during cold exposure compared to BAT-     subjects and upregulation of genes and proteins involved in lipid metabolism only in BAT (but     not muscle and white adipose tissue). Infusion of stable isotope tracers and metabolic     modeling techniques will be used to assess VLDL-TG kinetics. Positron emission tomography     computed tomography will be used for the identification and quantification of BAT.     Supraclavicular BAT, abdominal white adipose tissue, and skeletal muscle tissue biopsies     during cold exposure and thermoneutral conditions in conjunction with molecular biology     techniques will used to measure expression of genes and proteins involved in lipid     metabolism.   "
38154|NCT02786238|"     This study will be the first clinical trial to examine the impact of two different weight     loss interventions on novel mechanisms that promote obesity and impede its successful     treatment, including cognitive function and self-regulatory factors. The results will provide     important data about how impaired cognitive function and/or self-regulation promote obesity     and how different weight loss treatments may differentially impact these factors; this     information will be used to identify promising cognitive and self-regulatory treatment     targets for preventing further obesity development and for maintaining weight loss.   "
38261|NCT02784847|"     A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial     metabolism, for the preventative treatment of migraine.   "
38156|NCT02786212|"     Cardiac surgery with cardiopulmonary bypass (CPB) provokes a systemic inflammatory response     that can often lead to dysfunction of major organs. Activation of the contact system,     endotoxemia, surgical trauma, and ischemic reperfusion injury are all possible triggers of     inflammation. Previous studies demonstrated that pro-inflammatory cytokines play an important     role during this process. However, very little is known about the susceptibility of the     splanchnic organs to ischemic reperfusion injury. Although the incidence of intestinal     complications reported to be low, the in-hospital mortality in these patients was high at 15%     to 63%.      Dexmedetomidine, a highly selective α2-adrenergic agonist, can reduce the consumption of     other sedative and antinociceptive drugs and provide sufficient sedative effects with minimal     respiratory side effects. In addition, dexmedetomidine gradually has gained popularity in the     field of critical care. Preemptive administration of dexmedetomidine has shown to be     protective against inflammation, intestinal, renal, and myocardial injuries in animal and     human studies. Dexmedetomidine is also used as an anesthetic adjuvant during surgery to offer     good perioperative hemodynamic stability and an intraoperative anesthetic-sparing effect.     Perioperative use of dexmedetomidine can reduce intestinal and hepatic injury after     hepatectomy with inflow occlusion under general anesthesia. However, whether or not it can     exert protective effects on the above-mentioned organs, especially intestine, after cardiac     surgery remains unclear. The aim of this study is to evaluate the effects of dexmedetomidine     on intestinal, hepatic, and other organ injury in patients receiving cardiac surgery with     CPB.      In this double-blinded randomized controlled study, serum diamine oxidase activity, which is     a sensitive and specific marker for the detection of intestinal injury, is taken as the     primary endpoint. Other parameters reflecting the functions of liver (AST/ALT), lung (lung     injury score and CC-16), kidney (BUN/Cre), and heart (CK-MB/Troponin T), the biomarker of     endothelial injury (endocan) will also be determined. Besides, microcirculation parameters     measured with Cytocam® and near-infrared spectroscopy (NIRS) will be used to estimate the     protective effect of dexmedetomidine on microcirculation. The variables will be collected     perioperatively and will be followed up for 3 days after the surgery. Clinical outcome     parameters will be followed up for 3 months after the surgery.   "
38157|NCT02786199|"     Histological grade of hepatocellular carcinoma (HCC) is an important prognostic factor     affecting patient survival. It has been divided into four grades from I to IV on the basis of     histological differentiation. Grade I is the best differentiated consisting of small tumor     cells arranged in thin trabeculae. Cells with higher grade are larger and less differentiated     with hyperchromatic nuclei and loss of trabecular pattern.      Ultrasound is an imaging modality frequently used to evaluate liver tumors because of its     convenience, real-time, less expensive and no radiation exposure. However, ultrasonographic     evaluation by conventional B-mode image is semi quantitative and subjective. It still cannot     replace liver biopsy for the evaluation of HCC.      This study is aimed to quantify the image characters of B-mode image and the scatterer     properties using Nakagami distribution. Nakagami parameter is a general model to describe the     distribution of scatterers. Therefore, the investigators hypothesized that Nakagami parameter     may also reflect the histological changes in different grades of HCC.      In this study, the resected HCC tumor samples will be collected from the participants who are     going to receive surgical resection, and the tumor US images and Nakagami values will be     obtained via the single-element ultrasound system. The correlation between the ultrasound     backscatter parameter and the differentiation grade will be analyzed.   "
38158|NCT02786186|"     The main purpose of the current study will be to provide real - world evidence regarding the     safety and effectiveness of secukinumab in the management of patients with moderate to severe     chronic plaque psoriasis.   "
38159|NCT02786173|"     The PRIME Registry is a multi-center, observational study designed to evaluate immediate and     long-term outcomes (36 months) of endovascular revascularization in patients with critical     limb ischemia (CLI) and advanced peripheral artery disease (PAD).   "
38160|NCT02786160|"     The study is a randomised, placebo-controlled, double-blind, parallel study in obese     children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood     obesity treatment program, will be included. The participating children will be randomised     into one of three groups consuming either HMO (two groups) or placebo (one group).      The primary objective of the study is to establish the effects of HMOs on the faecal     microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in     children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic     profile and body composition in obese children.   "
38175|NCT02785965|"     The purpose of this study is to determine whether the use of electroacupuncture to dredge and     regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle     modification only in the treatment of anovulation and hyperandrogenism due to polycystic     ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive     electroacupuncture and lifestyle modification in combination, while the other one third will     receive lifestyle modification only.   "
38162|NCT02786134|"     Coronary flow reserve (CFR, calculated as the ratio of hyperemic over rest myocardial blood     flow) is emerging as a powerful quantitative prognostic imaging marker of clinical     cardiovascular risk. CFR provides a robust and reproducible clinical measure of the     integrated hemodynamic effects of epicardial coronary artery disease (CAD), diffuse     atherosclerosis, and microvascular dysfunction on myocardial tissue perfusion. Inflammation     is a key mediator of this constellation of abnormalities, affecting the entire coronary     vasculature, but no clinical trial to date has shown that directly reducing inflammation     lowers cardiovascular event rates. As such, the recently launched Cardiovascular Inflammation     Reduction Trial (CIRT) provides a unique opportunity for mechanistic investigation of the     impact of anti-inflammatory therapy on changes in CFR as a reflection of coronary vascular     dysfunction, which may precede clinical outcomes, particularly in patients at high-risk of     events. The investigators are ideally positioned to examine the impact of inflammation on     CFR, having extensive experience in both the quantitation of CFR using clinically-integrated     dynamic positron emission tomography (PET) and the ability to assess its association with     cardiovascular outcomes. The central hypothesis of this ancillary proposal, CIRT-CFR, is that     reducing systemic inflammation using low-dose methotrexate (LDM) will, compared to placebo,     quantitatively improve myocardial blood flow and coronary flow reserve as measured by PET     over one year, in stable CAD patients with type 2 diabetes or metabolic syndrome enrolled in     CIRT. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue     perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation     and function and, ultimately, symptoms and prognosis.   "
38163|NCT02786121|"     Several authors explain as the kinesiophobia plays an important role for the recovery after     orthopaedic surgery. The aim of the investigators study is to investigate if the     kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early     recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure     the fear level of movement. All the other variable that could influence the ILOA Score are     identified and collected: age, sex, body max index, ability of patient pre-surgery, type of     anesthesia, length of stay, pain, haemoglobin, possible complications.   "
38271|NCT02784717|"     This non-interventional field study will investigate rivaroxaban under clinical practice     conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients     with non-valvular atrial fibrillation in China.   "
38272|NCT02784704|"     This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to     assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with     meropenem in the treatment of complicated intra-abdominal infections (cIAIs).   "
38164|NCT02786108|"     The purpose of this study is to evaluate the safety and effectiveness of left gastric artery     embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is     blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight     loss.      Although there are many ways to treat morbid obesity, surgery is currently the only effective     method to be confirmed. But surgical treatment is likely to carry a high risk of     treatment-related complications, such as fistula or intestinal obstruction, etc. This study     is designed to help treat obesity using a method of transvascular interventional therapy,     which is minimally invasive and non-surgical.   "
38165|NCT02786095|"     This study is prospective Cohort study which was performed in multicenter (General Hospital)     in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The     purpose is to analyze complication, composite outcome (all cause mortality, hospitalization,     the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1)     the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker,     calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin,     coumadin, an NOAC)   "
38166|NCT02786082|"     The main objective is to study the pharmacokinetics of Azilsartan Tablets in human and     providing evidence for clinical study and clinical application of this product.   "
38167|NCT02786069|"     The main objective is to evaluate the effect of single dose Propionyl-L-Carnitine     Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical     pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for     market authorization registration.   "
38168|NCT02786056|"     Structural lung and airway alterations in CF lead to focal or heterogeneous abnormalities in     regional lung ventilation. The quantitative assessment of structural and functional     alterations in the lung is of great importance for the phenotyping and follow-up of CF     patients. The goal of this study is to assess the feasibility of measuring the changes in     proton density in the lung parenchyma with inflation and deflation during the respiratory     cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers.   "
38169|NCT02786043|"     The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on     clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic     characteristics and safety on healthy Chinese subjects to provide a basis for market     authorization registration   "
38170|NCT02786030|"     This study will evaluate a complex intervention based on a patient management tool (PMT),     combined with educational outreach to primary care doctors, nurses and other health workers,     in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of     respiratory care and respiratory health outcomes, and comorbid conditions, in adults with     asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the     intervention will be assessed by randomly allocating 48 primary care clinics to receive the     intervention or not, and comparing patient and clinic level endpoints that reflect the health     and quality of care provided over the following year. About 1250 patients known to have been     diagnosed with asthma and 700 with COPD in participating clinics and will be included in the     study. The primary endpoints for patients with asthma and COPD, respectively, will be     composite scores indicating appropriate prescribing and diagnostic testing. The third primary     endpoint, among all adult clinic users, will be rates of new diagnoses of asthma and COPD in     each clinic. Secondary endpoints will include the individual components of the composite     scores, health measures (hospital admissions and deaths), and indicators of appropriate     management of comorbid conditions such as cardiovascular risk factors. Eligible patients will     be identified and outcomes measured using electronic medical records.   "
38171|NCT02786017|"     The purpose of this study is to assess the safety and efficacy of injectable collagen     scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs)     transplantation in patients with Decompensated Cirrhosis.   "
38172|NCT02786004|"     This study is being conducted to determine the image quality of images using a new     investigational medical imaging device.   "
38173|NCT02785991|"     The purpose of this registry is to reflect on standard clinical practice in pulmonary vein     cryoablation in Spanish hospitals, the different procedure protocols, details of     intervention, complications, long-term follow-up strategy and results in these subjects.   "
38174|NCT02785978|"     Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo     measured activity in PD patients. The purpose of the study is to provide validation of the     ActiMyo, an innovative home-recording device enabling use in clinical trials and as an     innovative tool for PD patient care.   "
38177|NCT02785939|"     This phase II trial studies how well palbociclib works in treating patients with stage IV     squamous cell lung cancer that has come back after previous treatment. This is a sub-study     that includes all screened patients positive for the cyclin dependent kinase 4/6 (CDK4/6)     biomarker. CDK4/6 can cause tumor cells to grow more quickly. Palbociclib may decrease the     activity of CDK4/6 and may be able to shrink tumors.   "
38188|NCT02785796|"     In osteopathy is generally believed that the cranial bones are equipped with an inherent     mobility, which like any other joint may face restrictions on movement and then somatic     dysfunction. For this reason, different techniques are used with the aim of increasing the     mobility of the cranial bones. Some of these have been effective in modifying physiological     parameters related to the activity of the autonomic nervous system, such as cardiac function     or sleep latency. This study aims to test the effectiveness of a specific craniosacral     technique, compression of the fourth ventricle CV4, using the salivary marker alpha amylase,     which is sensitive to changes in the activity of the autonomic nervous system. To patients     recruited from students of AIMO, we will ask to provide saliva samples before and after CV4     treatment. In particular, saliva will be collected four times per patient: at the initial     time, after administration of a stressful event (hand immersion in ice water), immediately     after application of the CV4 technique and thirty minutes after the application of the CV4     technique. For each sample of saliva detected, we will proceed to measure the activity of     alpha amylase and flow rate, variables sensitive to the activation of the autonomic nervous     system.   "
38273|NCT02784691|"     The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on     osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis     allowing an improvement of transdermal diffusion of active (Diclofenac).   "
38178|NCT02785926|"     During pregnancy, the foetus is therefore chronically exposed to a large number of     substances. A number of studies have started to emphasize the effects of this antenatal     exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.).     However, in addition to these morphological effects, pesticides may also induce various     effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters     involved in many nervous system regulation pathways in man. This is particularly the case for     organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by     the coordinator of the project presented here demonstrated the presence of high levels of     this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition     of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated     by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate     particularly in preterm neonates, could therefore be affected.      The PhysioMéco project is therefore designed to study the possible links between antenatal     exposure to pesticides and modifications of respiratory control allowed by peripheral     chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays     in the meconium of neonates in combination with an exposure questionnaire to determine the     sources of these pesticides. Sleep and respiratory control will be studied in these neonates     nursed in incubators. Hypoxic test will be used in order to assess respiratory control     involving the peripheral chemoreceptors.   "
38179|NCT02785913|"     This phase II trial studies how well taselisib (GDC-0032) works in treating patients with     stage IV squamous cell lung cancer that has come back after previous treatment. This is a     sub-study that includes all screened patients positive for the phosphoinositide 3-kinase     (PI3K) biomarker. PI3K can cause tumor cells to grow more quickly. Taselisib may decrease the     activity of PI3K and may be able to shrink tumors.   "
38180|NCT02785900|"     The purpose of this study in AML patients is to test whether vadastuximab talirine     (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and     extends overall survival as compared to placebo combined with either azacitidine or     decitabine.   "
38181|NCT02785887|"     This is a randomized parallel group trial designed to evaluate the impact of implementing     geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA),     on the ability to deliver adequate chemotherapy treatment, as measured by relative dose     intensity (RDI).   "
38182|NCT02785874|"     Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk     turning into liver cancer,however, the investigators also discovered that patients taking     Statin live longer than patients who didn't take Statin in the incidence of liver cancer     death cases.   "
38183|NCT02785861|"     After treatment, women want to regain a 'normal' lifestyle while some factors interfere as     chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical     deconditioning . The following protocol will focus at this problem.It will consist of a brisk     walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic     during 20 minutes.   "
38184|NCT02785848|"     The investigators will explore barriers to improving self-efficacy, or the ability to feel in     control of their disease, and medication adherence with text messaging through surveys and     interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of     Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences     to improve and sustain adherence to daily medication through selection of     investigator-proposed or patient-generated text messaging strategies. Finally, the     investigators will fill in the literature gaps by describing barriers to self-efficacy and     medication adherence among adults with SCD as well as adolescents with SCD who are     transitioning to adult care.   "
38185|NCT02785835|"     Observational study. All HIV-infected patients who have been diagnosed of hepatocellular     carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD)     criteria, in the participant centers are included. Epidemiological, clinical and laboratory     data are collected. The clinical and epidemiological characteristics of HCC cases will be     analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed.     Mortality and its predictors will be also assessed. In those cases infected by hepatitis C     virus (HCV), the impact of HCV therapy on outcomes will be analysed.   "
38186|NCT02785822|"     Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is     associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in     isolation, its therapeutic management has special connotations sometimes favoring the low     response although the standard is the tendency to hyperresponsiveness.      Although there are studies comparing the combination of FSH and LH and FSH in controlled     hyperstimulation of these patients, there are no previous prospective randomized studies     comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG HP).      Therefore the aim of this study is to prove that both drugs are comparable in the treatment     of these patients. The test substances are marketed in Spain (Fostipur and Meriofert,     respectively) with an indication for use in these patients. In this study both medicines will     be administered in a randomized way under the usual conditions in which it is used in routine     clinical practice to compare the quantity of mature oocytes respect to the total oocytes     obtained, as a primary outcome measure.   "
38187|NCT02785809|"     The aim of this study is to investigate whether there is a correlation between anti-Müllerian     hormone during long-term use of combined oral contraceptives and the recovery time before     recovered menstrual cycle after discontinuation of oral contraceptives.   "
38254|NCT02784938|"     The purpose of this project is to evaluate a promising peer-run psycho-educational group     intervention titled Vocational Empowerment Photovoice (VEP) that aims to empower     individuals with the most disabling psychiatric disabilities to engage in vocational services     and pursue employment through the enhancement of their vocational hope, sense of vocational     identity, work motivation, work-related self-efficacy, and capacity to deal with psychiatric     stigma and discrimination.   "
38189|NCT02785783|"     This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps     detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the     participants will receive EndoRings™ assisted colonoscopy, while the other half will receive     standard colonoscopy.   "
38191|NCT02785757|"     Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The     guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show     that oncologists are reluctant to use it because of concern over bleeding, absence of     validated risk stratification tools and uncertainties concerning the optimal     thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each     cancer patient and individually tailor their thromboprophylaxis.      The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall     haemostasis assay that can be used to evaluate individual thrombosis risk      The secondary objectives are:        -  To define the limits of TGT parameters that indicate thrombosis risk in cancer patients        -  To evaluate values of other clotting activation markers in patients with cancer      Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin,     who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit     1). Thrombin generating capacity will be measured within the first month following diagnosis     and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at     the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a     period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are     foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.      Patients eventually undergoing second-line chemotherapy during the course of the follow-up     will remain on study.      The study will document all cases of symptomatic thromboembolic events together with the     relevant diagnostic work-up.   "
38192|NCT02785744|"     Gaucher disease is a most common genetic metabolic disease characterized by low platelet     number, liver and spleen enlargement and various forms of bone diseases including low bone     mineral density leading to brittle bones. Various treatment options are now available for     this disease.      The purpose of this research study is to determine the prevalence of Gaucher disease in     patients with low bone mineral density as observed by DEXA scan, which is a form of X-Ray of     the bone.   "
38193|NCT02785731|"     ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system     capable of harvesting rare circulating cells for analysis from a sample of peripheral blood     based on cellular size and deformability. In a small pilot study, scientists at the Medical     University of Vienna demonstrated that measurement of a combination of mRNA markers extracted     from CTCs captured using the Parsortix system could be used to identify women with ovarian     cancer. This study is designed to provide specimens for optimization of an assay using     clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor     markers) in combination with mRNA extracted from rare cells in the blood of women presenting     with a pelvic mass for the detection of malignancy.      Primary Objective: Optimization of an assay for the differentiation of women with benign     pelvic masses from those with malignant pelvic masses using mRNA markers extracted from CTCs     isolated from whole blood. Multiple serum tumor markers and mRNA markers will be measured,     and the results will be compared to the actual clinical diagnosis made for each patient     through other recognized methods (e.g. histopathology). The blood samples collected in the     course of this study will be used to finalize the selection of mRNA and/or serum tumor     markers to be evaluated in future prospective studies.      Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary     design of a mathematical algorithm to combine the multiple serum tumor and/or mRNA markers     for estimation of the risk of ovarian cancer.   "
38194|NCT02785718|"     Cardiovascular diseases are important causes of morbidity and mortality in the industrialized     world. Abnormalities in the coagulation system, causing a hypercoagulable state, are a known     risk factor for arterial and venous thrombosis. The contact activation system is part of the     coagulation system and consists of four proteins: coagulation factor XII (FXII), FXI,     prekallikrein and high molecular weight kininogen (HMWK). Clinical studies indicate an     important role for the contact activation system on the risk of arterial thrombosis.     Furthermore, there is substantial evidence from mouse studies that FXII and FXI participate     in the formation and stability of thrombi. In vitro studies show that collagen, present in     the vascular wall, is able to activate FXII and hereby stimulate thrombin formation and     potentiate the formation of platelet-fibrin thrombi and FXIIa is able to change the structure     of fibrin clots by binding to fibrin(ogen) and by generation of additional thrombin. However,     the contact system also participates in the process of fibrinolysis, which degrades thrombi.      The investigators would like to investigate the contribution of the contact activation system     to the formation of thrombi. The formation of a thrombus within the vascular bed is the main     cause for occlusion of an artery or vein, which can lead to an infarct such as a heart     attack. Due to the other functions of the contact system it is important to fully understand     how the contact system contributes to thrombus formation, before it can be used as a target     in the treatment of arterial thrombosis. The aim of this study is to determine the     contribution of the proteins of the contact system, mainly FXII and FXI, in the platelet     mediated formation and degradation of thrombi. This will be studied in flow models     (perfusion-flow model and Chandler loop), in a static model (ROTEM®) and using thrombin     generation assay.   "
38195|NCT02785705|"     Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch     from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for     preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed     to assess immunogenicity and safety profile of six vaccination schedules with different     sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.   "
38196|NCT02785692|"     Postoperative wound healing complications following preoperative radiotherapy represent a     severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34%     and more. The literature discusses intensely the advantages and disadvantages of this     multimodal treatment concept and there are different opinions. The Canadian prospective     randomized NCIC SR2 trial showed increased wound complication rates in the study arm     receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment     concept and the results shall now be analysed and published. The approach is to show that not     only the complication rates are comparable to international bench marks, but also the (still     intermediate time) local control rates.   "
38197|NCT02785679|"     Cow's milk protein (CMP) allergy is one of the most common food allergies and potentially a     fatal one. Early feeding with CMP has been considered in the past as a risk factor for     development of CMP allergy in high risk infants. Although other studies argue with this     assumption and suggest early exposure to CMP might be protective against atopic dermatitis     and CMP allergy. A cohort study that first introduction of CMP after 15-30 days of age,     raised the risk for CMP allergy.The aim of this study is to investigate if early and     continuous exposure to CMF will decrease CMP allergy rate.   "
38340|NCT02783794|"     The purpose of this study is to determine whether BP-C1 is effective in the treatment of     metastatic breast cancer patients who had previously received at least three lines of     chemotherapy.   "
38201|NCT02785627|"     The ANTELOPE trial is a longitudinal observational clinical study of changes in bone density,     structure and strength over 12 months in men receiving treatment for prostate cancer. Three     groups (n = 30 per group) will be compared, with bone assessments at baseline and 12 months.     Allowing for a 18 month recruitment period, 12 months follow-up and data analysis, the total     study length will be 3 years. The groups comprise:      Group A - Men with prostate cancer starting ADT      Group B - Men with newly diagnosed hormone sensitive metastatic prostate cancer, about to     start (or have started within the past 3 months) ADT and who will undergo chemotherapy with     docetaxel and prednisolone      Group C - Age-matched men without prostate cancer   "
38202|NCT02785614|"     The main objective is to evaluate the pharmacokinetics comparative studies in a single dose,     multiple dose   "
38203|NCT02785601|"     The main objective is to compare the pharmacokinetics in single dose, and effect of food on     the trazodone hydrochloride pharmacokinetics prolonged-release tablets.   "
38204|NCT02785588|"     This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for     imaging viable neonate and infant populations. This MR system has a smaller size and design     features that may make it more feasible to locate the system in close proximity to care areas     for neonates (birth - 1 month) and infants (>1 month to two years), such as clinical neonatal     intensive care units (NICUs) and other infant and neonatal care departments.   "
38205|NCT02785575|"     The study will compare a novel calculation model (HeProCalc AB) with a standard weight-based     and activated clotting time adjusted calculation for the dosing of Heparin and protamine and     assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.   "
38206|NCT02785562|"     Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression :     evaluation of clinical and pathological characteristics of PDL1 high expression patients     compared to patients with a weak or no expression of PDL1.   "
38207|NCT02785549|"     Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion     criteria and giving informed consent, will be included in the study protocol and will be     randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus     antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7     days, 30 days and 3 months from the onset of the episode.   "
38208|NCT02785536|"     Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US     primarily due to an unequal burden of tobacco-related disease from a disproportionate share     of smokers in African American and lower socioeconomic (SES) groups. Unlike many other health     risk behaviors, tobacco-related health disparities are increasing despite a large treatment     network of free telephone and in-person counseling services, perhaps due to significant     disparities in treatment outcomes. The goal of this project is to revise the standard     treatment for tobacco dependence to address key factors associated with treatment outcome     disparities and more fully meet the needs of lower SES and African American smokers thereby     reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting the     alarming increase in tobacco-related health disparities, and reducing a leading cause of     racial and socioeconomic health disparities in the US.   "
38209|NCT02785523|"     A phase III double-blind randomized clinical trial on the effects of ganoderma spore lipids     to the immunological response in patients with G.I. Cancers. The trial is randomized,     double-blind. Cancer patients are diagnosed based on pathology or cell biology. Patients are     randomized into 2 groups: both groups receive chemotherapy. Either group receives ganoderma     spore lipids or placebo capsules 600mg three times a day (TID) in addition to the     chemotherapy. Clinical evaluation includes chemotherapy drug toxicities, life quality     improvement. Blood biochemistry tests mainly include malondialdehyde (MDA), superoxide     dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis     factor (TNF)-α, interleukin (IL)-1b, interleukin (IL)-6, cell flow cytometry on Th1, Th2,     Th17, Treg cytokines, as well as serum cortisol, estradiol (female), progesterone (female),     testosterone (male), etc.   "
38277|NCT02784639|"     The goal of this multicenter prospective study is to validate, and ultimately translate in     routine clinical practice, the use of plasma analysis of ccfDNA for the determination of KRAS     mutation status in mCRC patients.   "
38210|NCT02785510|"     Parkinson's disease is the second most common neurodegenerative disease affecting about 1-3%     of population above 60 years. Recently, non-motor symptoms are getting more attention in PD     management. The pattern of PD onset and clinical course differ from one population to     another. Many studies have been conducted to determine the clinical profile of PD in     populations worldwide. However, no similar studies have been conducted in Egypt. Therefore,     the investigators will conduct a nation-wide, collaborative, cross sectional study to     determine the pattern of Parkinson's disease onset, clinical course, and non-motor symptoms     among Egyptian population.   "
38211|NCT02785497|"     Skin lesions, such as chronic ulcers and burns, represent a serious public health problem due     to high government costs, and scarce successful conservative treatments.There is a growing     scientific literature on the use of electrotherapy in the process of wound healing, but in     return there is a dearth of scientific studies on the use of various types of currents and     the different parameters in the proposed treatments.   "
38212|NCT02785484|"     The purpose of this randomized controlled trial is to determine whether constituent     disclosures on cigarette packs increase intentions to quit smoking. Previous studies have     been informative, but they have evaluated candidate graphic warnings, not constituent     disclosures. Furthermore, they typically expose participants to messages in controlled but     artificial experimental settings for a short period of time, using much lower frequency and     shorter duration of message exposure than found in the real world. This study addresses these     issues by evaluating the impact of constituent disclosures by randomly assigning smokers to     have their cigarette packs labeled with constituent disclosure messages or cigarette butt     littering messages.   "
38362|NCT02783508|"     Systematic opioids and inhaled nitrous oxide (N2O ) are common methods for pain relief during     labor. The aim of the current study is to evaluate the efficacy of systemic pethidine     compared to N2O given for pain relieve in term, multiparous women in labor.   "
43043|NCT02722265|"     To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration     of CS-3150 as monotherapy and in combination with calcium channel blocker or     renin-angiotensin system inhibitor in patients with essential hypertension.   "
38213|NCT02785471|"     The purpose of this study is to test a comprehensive, male-oriented, online screening and     referral (Screening for Mental Health; SMH) and male-oriented online information and referral     intervention program (Man Therapy; MT) to improve mental health and wellbeing with a focus on     prevention of suicide and help-seeking behaviors among middle-aged men. The online programs     will be offered together to maximize the effect on reducing suicide behavior and increasing     mental health help-seeking behaviors for men. If successful in decreasing suicide behavior     and ideation and increasing suicide help-seeking behavior, this intervention could be scaled     up to contribute to a reduction in suicide behaviors and deaths across the country.   "
38214|NCT02785458|"     This study evaluates the effectiveness of an electronic health record based educational     intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk     medications. Half of the participants will receive the intervention, while the other half     will receive the usual amount of information (usual care).   "
38215|NCT02785445|"     The objectives of the Healthy.io Method Comparison and User Performance Study are:        1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission®          U500 Urine Analyzer.        2. To evaluate the user performance of Dip.io Device under actual use conditions (home          environment) based on a user questionnaire and rating scale.   "
38216|NCT02785432|"     1. Examine the use of low level therapeutic laser (LLLT) combined with physical therapy for          improvements in pain, range of motion, and function in individuals with chronic pain          from musculoskeletal conditions.        2. Compare changes in pain, mobility, and ability to return to home/work/recreational          activities between treatments with standard physical therapy plus LLLT or the standard          physical therapy program alone.   "
38217|NCT02785419|"     After stroke, individuals often have persistent difficulty using the arm and hand in everyday     functional tasks that reduces quality of life. Currently available rehabilitation techniques     are not adequate and new protocols are needed that are based on an understanding of how brain     regions work together to produce skilled movement. This research project aims to improve our     understanding of how the brain controls movement after stroke and determine whether a period     of motor practice that targets specific brain regions through the addition of action     selection demands leads to improved arm function. We hypothesize that arm motor function and     the ability to efficiently activate the action selection motor circuit during movement will     improve after training.   "
38218|NCT02785406|"     The purpose of this study is to determine the effectiveness of a medication called suvorexant     in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.   "
38219|NCT02785393|"     The purpose of the study is to asses the potential interactions between methamphetamine and     doxazosin in methamphetamine-dependent volunteers who are not seeking treatment. The study     will evaluate the effects of doxazosin on the cardiovascular and subjective effects of     methamphetamine in a human laboratory study.      The primary objective is to determine the safety of treatment with doxazosin in     methamphetamine-dependent volunteers by examining hemodynamic and subjective effects of     administration of ascending doses of methamphetamine and a placebo dose during treatment with     doxazosin.      The secondary objective is to determine effects of treatment with doxazosin, as compared to     placebo, on subjective effects produced by administration of methamphetamine or placebo   "
38225|NCT02785315|"     People with mild cognitive impairment (MCI) are at a greater risk of developing dementia.     Therefore, it is important to develop effective non-pharmacological interventions to     facilitate their cognitive and activities of daily living (ADL) function, which will also     prevent or delay their progression to dementia and reduce associated healthcare and social     costs. There are currently a variety of cognitive interventions, mainly categorized as     remediation and rehabilitation approach. Research to compare their contents and effectiveness     is strongly needed. The information can be used to individualize cognitive intervention based     on specific cognitive profile of the patient.      This study aims to determine the immediate and long-term efficacy of the remediation approach     and rehabilitation approach in enhancing the cognitive and ADL function. The research     questions include 1) whether the rehabilitation approach compared with the remediation     approach has better effects on improving ADL function; (2) whether the remediation approach     may only enhance the performance on the cognitive tests rather than on the ADL function. This     study will also explore whether the attitudes of caregivers on providing ADL assistance     affect effects of cognitive intervention.   "
38278|NCT02784626|"     In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for     sedation can reduce postoperative pain than that of propofol, the investigators examined the     ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total     knee arthroplasty.   "
38220|NCT02785380|"     Management of recurrent HCC is urgent and several treatments have been developed .Repeat     hepatectomy is considered to be the first choice for recurrent HCC.      Unfortunately, repeated open hepatectomy can be performed only in a small proportion of     patients due to inadequate liver function reserve, widespread recurrence or high     invasiveness. Given that recurrent tumors are usually detected at small size during follow-up     after initial surgery, radiofreqency ablation (RFA), which is less invasive, may be locally     curative and causes minimal damage to liver function reserve,has been widely used. However,     the re-recurrence rate after RFA is more than 50%,and the recurrence-free survival is less     than 20%. Recently, satisfactory short- and long-term oncological outcomes have been reported     for laparoscopic surgery (LS) for the treatment for primary HCC with cirrhosis. Some single     center pilot studies reported that LS may, compared with open surgery, improve the prognosis     of HCC with less blood loss and shorter hospital stay. LS was initially considered not     suitable for recurrent HCC due to postoperative adhesions that might make laparoscopic     surgical procedure more difficult and less safe. With improvement in technique and     experience, recent studies showed that LS for recurrent HCC in cirrhotic patients is a safe     and feasible procedure with good short-term outcomes. However, thus far, no study has been     performed to evaluate the long-term oncological outcomes of LS for recurrent HCC, and compare     those results to that for RFA. To clarify these issues, a multicenter retrospective     comparative study by using propensity score matching method that included a large consecutive     series of patients with recurrent HCC within Milan criteria, who underwent LS or RFA, was     performed.   "
38221|NCT02785367|"     The pH levels of a neonatal at his birth are an important factor in establishing the     connection between events that occurred during the actual time of birth, to the risk of a     significant morbidity development in the future. Gas values in cord blood are measurable and     represent the condition of the fetus close to the time of birth. Their level is one of the     essential criteria which are used to define acute hypoxic event during birth. As the oxygen     supply to the fetus significantly disturbed, deficiency of oxygen in the tissues is growing.     Therefore, the tissues begin to accumulate large amounts of acid and thereby developing fetal     blood acidosis. Many works connected the presence of cord blood acidosis to development of     neonatal cerebral palsy. According to the American Association of Obstetrics and Gynecology,     cord blood gas sample is necessary when a prenatal event may be related (rightly or not) with     negative neonatal outcome. This approach might be necessary when the case is legally     controversial and there is a need to prove that umbilical cord gas values were normal at the     prenatal period.   "
38222|NCT02785354|"     The study is an analysis using the French national health insurance database, six months     after the beginning of NOAC launch in the NVAF indication.      The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding,     arterial thrombotic events, myocardial infarction (MI), death) between patients starting a     NOAC and patients starting a VKA for NVAF in 2013   "
38223|NCT02785341|"     Although treatments significantly increase the life expectancy of cancer patients, their     quality of life is more or less reduced. The development of supportive care, such as physical     activity, is one of the tools that should be promoted to maintain quality of life and reduce     treatment side effects, including fatigue.      This study was developed to understand the different biopsychosocial effects of a physical     activity program carried out with patients suffering from various types of cancers, and to     facilitate and improve the implementation of this type of activity in health care facilities.      Study randomized, controlled, cross-over intervention evaluating a 12-week supervised and     adapted physical activity program.      Participants were assigned to one of two groups: Group A which first follows a 12-week     physical activity program, then undergoes usual care for 12 additional weeks, or Group B,     which continues usual care for 12 weeks (control group) and then starts the physical activity     program for 12 additional weeks. Quality of life (with questionnaires for 2 groups) ,     well-being, fatigue, physical capacity, leptin concentration, goal setting and level of     physical activity are evaluated during this protocol.      By understanding the multidimensional effects of a physical activity program for various     cancer types, depending on the time of proposing the program, by evaluating the correlations     among all these variables, and by evaluating long-term effects, the IPCAPA study contributes     to identifying the physical activity program which will be effective, viable and feasible for     all patients undergoing chemotherapy, whatever the type of cancer.   "
38224|NCT02785328|"     Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good     daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning     is necessary for knowledge consolidation. A key role of sleep has clearly been demonstrated     in memory consolidation in adults. Sleep leads to strengthen memory by promoting brain     plasticity. Surprisingly, sleep influence on learning stabilization has scarcely been studied     during childhood and in children affected by sleep disorders. Yet, sleep disorders concern     almost 30% of children and are frequently related to a worsening in academic performances.     Classical neuropsychological evaluations of these children, based on daytime learning, often     fail to determine cognitive profiles explaining their academic difficulties. The     investigators hypothesize that a lack of sleep-dependent consolidation could take an active     part in these children's cognitive and academic difficulties. This proposal aims at     characterizing interactions between sleep, learning and memory processes that have not been     studied in children of elementary school age (6-12 years). The investigators will evaluate     sleep-dependent memory consolidation processes in children with sleep disorders before and     after treatment and healthy controls. Neuropsychological testing and academic performances     will be also evaluated.. The comparison of performances obtained before and after medical     treatment, will allow to understand whether normalisation of sleep quality permits the     restoration of sleep-dependent memory consolidation.   "
38226|NCT02785302|"     This is a multi-site, longitudinal study and it describes the transition process of     behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific     care to adult care. To achieve this goal, the transition process is characterized from the     perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and     receiving adult clinic staff.   "
38227|NCT02785289|"     The purpose of this study is to compare the performance of cotton and flocked swabs for     vaginal self-sampling.   "
38228|NCT02785276|"     Aim      The general aim of this study is to improve post-operative pain and reduce morphine     consumption following laparoscopic ventral hernia repair (LVHR). We specifically aim to     conduct a randomized, double blinded, controlled trial to investigate the effect of     intra-peritoneal local anaesthesia infusions on post-operative morphine consumption and.      Methods:      Patients will be randomised by computer generated random numbers (random permutation) and     opaque envelope methods. At closure, one small 2mm catheter belonging to the AutoFuser pain     pump system will be placed in the peritoneal cavity between the onlay mesh and parietal     peritoneum. In the treatment arm patients will receive 275mL of 0.2% ropivacaine at 4mL/h. In     the placebo arm, 275mL of 0.9% normal saline will be used in a similar fashion. The infusions     will run for 68 hours total. All members involved in patient care (with the exception of one     independant research fellow) will be blinded to the above. After 68 hours the pump will be     stopped and the catheter will be removed. Assessment of post-operative pain will be performed     by visual analogue scale, and total opiate consumption will be collected and converted into     morphine equivalents.      Health significance:      Local anaesthesia has become an important addition to multimodal regimens of analgesia     following surgery. Recent studies have shown that local anaesthetic (LA) wound infiltration     has improved post-operative pain when compared with standard opioid regimens for pain relief.     Only one previous study looked at bupivacaine infusions into the hernia sac for three days     following LVHR. This study found no improvement in post-operative pain or morphine     consumption. We aim to demonstrate improved pain and reduced morphine consumption using an     alternative catheter insertion technique and ropivacaine as the desired LA agent.   "
38229|NCT02785263|"     The purpose of this study is to maximize patient involvement in the treatment of anal cancer.     Specifically, the investigators will investigate whether patients wish to take part in the     decision making on radiation dose and whether they want a high or low radiation dose.   "
38230|NCT02785250|"     Immunotherapeutic survivin vaccine DPX-Survivac, low dose oral cyclophosphamide, and IDO1     inhibitor epacadostat will be tested together for the first time in patients with recurrent     ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential     immune-modulating activity of the combination of these agents.   "
38232|NCT02785224|"     Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors     plan to conduct a pertinent mediation analysis using prospectively collected data from 2     prior randomized clinical trials of in-hospital cardiac arrest. These trials reported     positive results on the vasopressin-steroids-epinephrine (VSE) combination. The current     analysis is aimed at identifying mediators of the benefit associated with VSE, potentially     attributable to its stress-dose steroid subcomponent. Tested mediators will include arterial     pressure in the early postresuscitation period (primary), and arterial blood lactate in the     early postresuscitation period and renal failure free days (secondary).   "
38233|NCT02785211|"     Background: It is essential to understand how to prevent and treat the epidemic of     depression. Several studies have reported the prevalence of depressive symptoms in the urban     population in China, but there is a lack of information regarding intervention for depression     in rural left behind old elderly people.      Objective: To evaluate the effectiveness of a Modified Behavioral Activation Treatment (MBAT)     Intervention on reducing depressive symptoms in rural left behind elderly people.      Methods: 80 rural left behind elderly people who had a Geriatric Depression Scale(GDS) score     between 11 and 25 will be recruited and randomly assigned to the intervention (n=40) and     control group(n=40). The intervention group will be received both MBAT and treatment-as-usual     for 8 weeks while the control group received treatment-as-usual. Both groups will be assessed     with the GDS, Beck Anxiety Inventory (BAI), and Oxford Happiness Questionnaire (OHQ) at     baseline, immediately post-intervention, and at 3 months post-intervention.      Significance: This is the first time BA psychotherapy will be used in China.The current study     will develop an intention model based on the traditional BA and CBT. The recurrence and     seriousness of depression symptoms may be reduced by the intervention program. We hope that     MBAT in clients will provide a direction for the management of mental health in rural     left-behind elders..   "
38234|NCT02785198|"     Overall project design: This PhD project involves a randomized study on diabetic individuals     with healing resistant wounds, comparing the effect of passive movement of the lower limb     with standard treatment of diabetic wounds.      How to effectively improve the condition of peripheral arterial disease is limited. The     primary purpose of this study is to uncover whether passive movement of the lower limb will     influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle     oxygen demand is likely to increase both blood flow rate and the number of capillaries, which     would induce the healing of wounds, that were not previously possible.      The secondary purpose is to increase understanding of the pathophysiological processes in     wound healing through the study of biochemical markers of vascularization, inflammation and     stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of     the number and quality of endothelial cells and Capillary density and to develop new     quantifiable methods to evaluate wound healing in.      The project is a randomized trial, consisting of simple passive training to improve blood     vessel function, increase the growth of the smallest blood vessels, thereby preventing     ulceration and ultimately amputation.   "
38235|NCT02785185|"     A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.   "
38236|NCT02785172|"     Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque     Psoriasis   "
38237|NCT02785159|"     Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis   "
38238|NCT02785146|"     A randomized, paralleled control clinical study investigating Huaier Granule for prevention     of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the     efficacy and safety.   "
38239|NCT02785133|"     This study uses a prospective non-randomized, non-controlled design. Five-hundred (500)     subjects having previously received a peripheral intravenous therapy will be enrolled into a     single treatment group. The purpose of the study is to evaluate the safety, feasibility, and     improved energy levels following treatment with a low-light source integrated into an     existing peripheral intravascular catheter. The absence of a control group is based on the     following reason:This is a pilot investigation to establish a baseline understanding of the     safety, feasibility, and cursory utility of polychromatic light emitting diodes integrated     into an existing 20-gauge 1.0 inch intravenous catheter to improve self-reported overall     subject energy levels.   "
38252|NCT02784964|"     1. To assess the safety of allogeneic injection of expanded ADSCs to patients with knee          osteoarthritis        2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee          osteoarthritis   "
38240|NCT02785120|"     This is a phase 2, multicenter, randomized, double-blind (within dose), placebo controlled,     parallel-group, dose-range finding study to evaluate the efficacy and safety of TF0023 spray     versus placebo in functional improvement of patients with ischemic strokes under standard of     care.      Objective of the study:      To evaluate the efficacy of TF0023 spray compared with placebo for functional improvement of     patients with ischemic strokes measured by the change from baseline in the mRS score for all     randomized patients at Week 16 for Part A and Part B, separately.   "
38241|NCT02785107|"     The promotion of physical activity (PA) is paramount to public health, yet interventions in     the social cognitive tradition have yielded negligible improvements. Two reasons for these     results may be the over reliance on intention as the proximal determinant of behaviour and a     lack of consideration of implicit/automatic determinants of PA. The purpose of this study was     to apply Multi-Process Action Control (M-PAC), a framework centered on PA     intention-translation and the gradual building of habit to examine PA change using a two-arm     parallel design, randomized controlled trial.   "
38242|NCT02785094|"     This study focus on measuring effect of Egyptian Primigravidas' education level and     accessibility to social media on rate of maternal request option offered for non-indicated     primary caesarean section.   "
38243|NCT02785081|"     The purpose of this study is to evaluate the thoracic skin to epidural space depth in     children and define the ratio between the straight and inclined thoracic skin to epidural     depth.   "
38244|NCT02785068|"     A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in     RAS/RAF wild-type Metastatic Colorectal Cancer.   "
38245|NCT02785055|"     This blinded, randomized study compares standard palpation to ultrasound-assisted landmark     identification of the thoracic spine for thoracic epidural catheterization.   "
38246|NCT02785042|"     This prospective, single-arm clinical multicenter study intends to measure normal structural     parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the     macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic     descent volunteers. The main goal of the study is to provide the range of these structural     parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10     study sites will recruit subjects. Overall an approximately equal age distribution from 18 to     90 years and an approximately equal number of females and males will be enrolled     (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT     imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing     in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at     a second visit within 30 days of the initial visit. All examinations performed on the     subjects are non-significant risk procedures.   "
38247|NCT02785029|"     This prospective, single-arm clinical multicenter study intends to measure normal structural     parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the     macula using the Heidelberg Spectralis OCT device. This study is conducted in     African-American descent volunteers. The main goal of the study is to provide the range of     these structural parameters in normal eyes. The study will include at least 240 normal     volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age     distribution from 18 to 90 years and an approximately equal number of females and males will     be enrolled (approximately 40-60% females in each age group). All subjects will undergo     Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and     visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans     may be performed at a second visit within 30 days of the initial visit. All examinations     performed on the subjects are non-significant risk procedures.   "
38248|NCT02785016|"     This is a prospective, non-randomized, observational, single center study in which subjects     that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling     operative procedure.   "
38249|NCT02785003|"     This study will evaluate the effectiveness of ketamine infusions in the management of acute     pain following open or laparoscopic colorectal surgery cases. Half of patients will receive     the institutional standard of care and a placebo infusion (no active medication). The other     half of patients will receive the institutional standard of care and a ketamine infusion. All     subjects and staff will be blinded as to whether they are receiving placebo or ketamine.   "
38250|NCT02784990|"     Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery     can be accompanied by complications among which the main one is pancreatic fistula, which     leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity,     a fistula can be managed medically, with the implantation of a la pose d'un percutaneous     drain, endoscopic treatment, or revisit surgery. It has been shown that early management of     the fistula prevents it from evolving towards major complications such as haemorrhage or     serious intra-abdominal infections.      To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic     enzyme, amylase, in the drains. However in certain clinical situations, patients present     post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase     with no clinical consequences.      It is therefore necessary to identify another early early marker of pancreatic fistula that     corresponds better to clinical signs.      In a preliminary study conducted in 65 patients, the investigators recently found that     another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula,     but this requires confirmation in a greater number of patients.      The objective is to evaluate the diagnostic performance of lipase in the drains for the early     detection of pancreatic fistula with clinical repercussions in the 30 days following the     surgery.      The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of     blood and a tube of drain liquid.   "
38251|NCT02784977|"     Primary aim of the TURKAPNE (The Turkish Sleep Apnea Database) study is to generate a     cross-sectional nationwide database to define clinical and polysomnographic characteristics     of the sleep apnea patients in Turkey. Associations of phenotypes of sleep apnea patients     with metabolic and cardiovascular diseases as well as risk for traffic accidents will be     explored as secondary aims. Impact of treatment of sleep apnea on metabolic and     cardiovascular complications as well as compliance with positive airway pressure treatment     will be further explored longitudinally.   "
38255|NCT02784925|"     Ultrasound (US) B mode image is an alternative method to measure tissue structure and has     proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing     the transducer onto the skin with too much force will significantly reduce the subcutaneous     adipose tissue thickness. In this study, a force controlled system combined with US     transducer was used for 3D subcutaneous fat imaging and reconstruction.   "
38256|NCT02784912|"     Prevalence of HF reaches 1-2% of developed populations, and consequently a significant     problem becomes more frequent occurrence of ventricular arrhythmias (VA) - sustained     ventricular tachycardia (sVT) and electrical storm (ES) requiring radiofrequency ablation.      The aim of the study is to create a model of risk stratification to identify patients with     increased risk of occurrence of composite (cardiovascular death or rehospitalization,     arrhythmia recurrence) and secondary (inadequate device therapy, all-cause death or     rehospitalization, intensification of atrial arrhythmia) endpoints after ablation of ES or     sustained VT. Model will be based on additional measurements of N-terminal pro brain     natriuretic peptide (NT-proBNP), Galectin-3, suppressor of tumorigenicity 2 (ST2), high     sensitive troponin T (hs-TnT), high sensitive C-reactive protein (hs-CRP), iron deficiency to     clinical-, electrocardiographic- and echocardiographic assessment.   "
38257|NCT02784899|"     One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary     shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far,     hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is     a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery     resistance by selectively dilating pulmonary artery. In this prospective, randomized, double     blind study, investigators are planning to investigate the effects of iloprost on respiratory     physiology (intrapulmonary shunt, deadspace, oxygenation, etc).   "
43082|NCT02721758|"     The purpose of this study was to test whether a brief motivational intervention is associated     with enrollment in cardiac rehabilitation.   "
38262|NCT02784834|"     The purpose of the study is to investigate the safety of the investigational drug called     dimethylfumarate (DMF). DMF is a type of drug called an immunomodulatory drug. This drug is     approved by the United States (U.S.) Food and Drug Administration (FDA) as a treatment for     patient with multiple sclerosis.      Although there is evidence from tests on laboratory animals that DMF can decrease the number     of CLL cells, we do not know if this will work in humans with CLL. This drug will be given to     humans with CLL for the first time in this study. Therefore, the goal of this study is to see     if DMF is safe and tolerable in study participants. Participants will be evaluated to find     out what effects (good and bad) DMF has on the body and see how long the drug stays in the     body.   "
38263|NCT02784821|"     Prolonged antibiotic use in preterm neonates has significant consequences on the developing     intestinal microbiome, metabolome and host response, predisposing the neonate to various     major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis,     bronchopulmonary dysplasia (BPD), and mortality.      The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant     consequences on the developing intestinal microbiome, metabolome and host response,     predisposing the neonate to various major morbidities. It is possible that the effect of this     widespread antibiotic use outweighs the potential benefits. This study will randomize preterm     infants born at less than 33 weeks gestation to either pre-emptive antibiotics or     no-pre-emptive antibiotics.      The purpose of this research is to evaluate the risks and benefits of current practice to     determine optimal levels of antibiotic use that protects the babies from infection with     minimal effect on the microbiome and subsequent adverse outcomes related to overuse of     antibiotics.   "
38264|NCT02784808|"     This study is designed to analyze the frequency and incidence rate of pulmonary complications     in JIA participants who received biological DMARDs and non-biologic DMARDs. The participants     having evidence of of a prescription or administration of one of the biologic or non-biologic     DMARDs will be included in five different treatment groups. Data from the Thomson Reuters     MarketScan® Commercial Claims and Medicare Supplemental Databases will be used to estimate     the incidence rate of pulmonary complications.   "
38265|NCT02784795|"     The main purpose of this study is to evaluate the safety of the study drug known as LY3039478     in combination with other anticancer agents in participants with advanced or metastatic solid     tumors.   "
38279|NCT02784613|"     This is an unblinded study to be conducted at a single research center, San Diego Sexual     Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene     daily for twenty weeks. After the informed consent is signed, a baseline physical     examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina,     will be performed. Physical examination and vulvoscopy with detailed photography of the     vulva, vestibule and vagina, will be repeated prospectively every 4 weeks for a total of 20     weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva,     vestibule and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4     weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12, weeks (vulvoscopy session     4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily     administration of 60 mg ospemifene.   "
38266|NCT02784782|"     Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they     have a large impact on patient's wellbeing and are a large economic burden to society.     Thoracolumbar burst fractures might not need the standard care of brace immobilization for     adequate treatment and a functional treatment might lead to same or better functional     outcomes. Besides that, with functional outcome length of hospital stay might decrease and it     might also be cost effective compared to bracing.      Objective: The investigators aim to study the use of braces for thoracolumbar burstfractures,     not only by measuring the functional scores and the effect of the bracing or functional     treatment on the increase in kyphosis angle, but also on (health related) quality of life and     health economics. The investigators hypothesize that no treatment is superior over one other.      Study design: This project is a randomised controlled trial comparing brace and no brace     treatment on function, kyphosis angle, pain, quality of life, and costs.      Study population: Patients between 18 and 65, with a single level thoracolumbar burst     fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees     and patient has to be neurologically intact. Patients are excluded when they are overweight     (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge     of the Dutch language. Patients included in the brace group will automatically take part in a     brace compliance study.      Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the     other group receives no TLSO Main study parameters/endpoints: The primary outcome of this     study is the functional score at six months after trauma. Secondary outcomes are pain,     kyphosis angle, health related quality of life, healthcare costs and brace compliance.      Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no     potential risks are known comparing a brace and a functional treatment. Investigators aim     that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and     less costs. Patients will be seen at first presentation and during two year follow up at the     outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray     as part of standard care is made. At or just before each scheduled appointment they will fill     in questionnaires taking from 15-45 minutes.   "
38267|NCT02784769|"     During their biological life, proteins undergo molecular aging due to many non-enzymatic     post-translational modifications that alter their structural and functional properties. These     reactions concern all proteins but especially tissue proteins (whose half-life in the     organism can be several decades) and lead to the formation of complex products called PTMDPs     (post-translational modification derived products). Molecular aging is responsible for the     alteration of protein properties which may cause changes in mechanical properties of tissues     during aging and pathologies. However, the involvement of these processes in vivo remains     unclear, particularly in the aneurysmal pathology. So, the aim of this study is to determine     whether the molecular aging of matrix proteins within the vessel wall may participate in the     development of aortic aneurysm.   "
38268|NCT02784756|"     The study will prospectively determine the clinical utility of CMV cell-mediated immunity     using the Quantiferon test. The investigators will use the assay results to tailor the     duration of CMV prophylaxis in solid organ transplant patients.   "
38269|NCT02784743|"     Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date     and most of them are more than 15 years old. To address this issue in April 2000, the     investigators started studies to update the epidemiology of lymphatic filariasis. There is no     ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive     chemotherapy treatment or vector control.      To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin     combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly     endemic villages of Mali.   "
38270|NCT02784730|"     Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly     medical devices used for the administration of chemotherapy.      Placement of these devices via central venous access is sometimes responsible for     complications.      The incidence of these complications is correlated with the device holding time.      A strategy of iterative PICC placement could significantly reduce these complications.   "
38274|NCT02784678|"     The purpose of this study is to confirm that minimally invasive closed reduction and internal     fixation with fully threaded headless cannulated compression screws for distal radius     fracture repair has advantages over conventional open reduction internal fixation with     titanium plates, providing superior fragment stability and allowing for early rehabilitation     exercise of the wrist joint, which improves recovery of function. Also to show that minimally     invasive closed reduction and internal fixation with fully threaded headless cannulated     compression screws is the more suitable surgical method for repair of distal radius fracture.   "
38275|NCT02784665|"     Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger     patients. It is characterized by serous detachment of the neurosensory retina with or without     serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image     distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be     treated with traditional laser photocoagulation, but it has the side effects of causing RPE     atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment     but it's more than most families can afford to pay because of the high cost, what's more, it     is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium     (RPE) atrophy and RPE rip.      To date there is no international consensus on the optimal treatment of CSC Many     retrospective studies suggest that micropulse laser (MPL) therapy may also be effective     without obvious complications in this disease.      The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute     central serous chorioretinopathy compared with the traditional laser coagulation.   "
38276|NCT02784652|"     Bone metastasis causes bone destruction and skeletal related events (SRE) including     compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative     treatments for pain control and local control have become important and multidisciplinary     multimodality approach is needed for treatment of bone metastasis.      The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that     bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In     previous retrospective reports, the combination of local RT and systemic bisphosphonate was     more effective than RT alone.      Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in     combination with zoledronic acid on pain relief and the safety of RT in bone metastasis     patients with gastrointestinal tumors.   "
38281|NCT02784587|"     Based upon Northern New England Cardiovascular Study Group data, the rate of post operative     atrial fibrillation (POAF) requiring treatment following coronary artery bypass grafting     (CABG) at Maine Medical Center (MMC) is currently 30%. Nationally, POAF occurs in up to 40%     of patients post CABG, 50% of patients after valve surgery, 64% of patients post mitral valve     and CABG and 49% after aortic valve replacement. Atrial fibrillation worsens a patient's     hemodynamic status and increases the risk of congestive heart failure (CHF), embolic events     and longer ICU stays leading to increased patient morbidity and strain on financial     resources. In the U.S., POAF carries a higher risk of stroke (37% OR 2.0 in-hospital     mortality (OR = 1.7), worsened survival (74% versus 87%), and an additional 4.9 days and     $10,000-$11,500 in hospital stay costs.      Atrial fibrillation requires both an initiation trigger and favorable environment for     maintenance and the sympathetic and parasympathetic nervous systems play important roles in     this regard. Unfortunately, the precise mechanisms of POAF are still being investigated. This     postoperative complication has persisted in spite of efforts to mitigate it pharmacologically     with beta blockers and amiodarone, an experience shared by most other cardiac surgery     centers.      The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion     and first thoracic sympathetic ganglion. By modulating the sympathetic component of the     autonomic nervous system, stellate ganglion stimulation has been shown to facilitate     induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies     have further supported this model.      Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest     that this technique may reduce or prevent episodes of POAF requiring treatment. The     investigator's ultimate goal is to determine whether SGB reduces the incidence of POAF in     specific cardiac surgery populations at MMC. First, however, the investigator proposes to     test the hypothesis that SGB, performed perioperatively by cardiac anesthesiologists in a     population of patients undergoing cardiac surgery, is both safe and clinically feasible.   "
38282|NCT02784574|"     This study aims to investigate current aftercare activities in Denmark after intensive care     unit (ICU) treatment. The hypothesis is that a large number of hospitals offer aftercare, and     these interventions are heterogenic and differ between hospitals and regions.      This study is an electronic questionnaire survey that aim to describe and map Danish     aftercare activities, and future development plans in this field.   "
38283|NCT02784561|"     The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG     (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in     Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem     cell transplantation.   "
38284|NCT02784548|"     This study will develop a virtual reality-based treatment for phantom limb pain among     Veterans and test it against the most established behavioral therapy for phantom limb pain,     mirror therapy.   "
38285|NCT02784535|"     Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic     hypotension are scarce and not effective. If left untreated, these patients have the highest     risk of syncope, falls and fall-related injuries. The proposed study will determine the     clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated     with neurogenic orthostatic hypotension in patients with autonomic failure.   "
38286|NCT02784522|"     This study protocol represents an attempt to objectively choose appropriate methods for     internal fixation of proximal humerus fractures in older patients by comparing locking     compression plate with conventional steel plate fixation to improve shoulder function.   "
38287|NCT02784509|"     The purpose of this study is to determine the effect of severe obesity on physical activity,     sedentary behavior and cardiometabolic risk factors during childhood and adolescence and     whether these associations are modified by race. Additionally, the study will investigate the     contributions of (total, regional, and depot-specific) fat accumulation on changes in     physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and     adolescence.   "
38288|NCT02784496|"     The goal of this clinical research study is to collect data about the long term safety and     tolerability of ruxolitinib when given to patients with MF.   "
38289|NCT02784483|"     The purpose of this pilot study is to gain initial insights into the biologic and clinical     effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may     provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially     be relevant to its future development in Multiple Myeloma (MM) and other indications.   "
43099|NCT02721537|"     Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as     measured by 31P MRS?   "
38290|NCT02784470|"     Selection of the optimal treatment for gastric outlet obstruction in patients with radically     unresectable gastric cancer remains controversial because previous studies comparing the two     procedures had a small sample size as well as they included various etiologies such as     gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the     patient population. Therefore, to establish the standard of care for patients with radically     unresectable gastric cancer with gastric outlet obstruction, a larger prospective,     randomized, controlled clinical trial using a single type of stent is warranted.   "
38291|NCT02784457|"     Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe     ovarian hyperstimulation syndrome and had cancelled embryo transfer   "
38292|NCT02784444|"     This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given     orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis. The     primary efficacy endpoint, hepatic histological improvement in NAS will be assessed at 12     months. Visits to the clinic will be at baseline, 1, 2, 3, 6, 9, and 12 months, with one 2-     week follow-up visit.   "
38293|NCT02784418|"     Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic     patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary     intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.      Treatment:CTO PCI, as per standard clinical practice.      Control: Patients randomized to sham-procedure will undergo only bilateral arterial access,     without angiography or PCI being performed.      Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire     duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement     in individual components of patients' health status (3) Greater improvement in exercise     capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural     and long-term   "
38416|NCT02782780|"     Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because     there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and     daily functioning, this study will investigate whether a type of behavioral sleep treatment     called Cognitive Behavioral Therapy for Insomnia (CBTi) can help Gulf War Veterans with GWI.     CBTi is a multicomponent treatment where patients learn about sleep and factors affecting     sleep as well as how to alter habits that may impair or even prevent sleep. The investigators     hypothesize that helping Gulf War Veterans learn how to achieve better sleep with CBTi may     also help to alleviate their other non-sleep symptoms of GWI.   "
38294|NCT02784405|"     Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the     treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel     calibers and to auto-expand after their release to self-appose to vessel walls is     particularly useful in the presence of ectasic coronary arteries or significant vessel     tapering. The investigators planned this study to assess the feasibility, the effectiveness     and the safety of the implantation of self-apposing, drug-eluting Stentys stents for     percutaneous coronary intervention.      Consecutive patients undergoing percutaneous coronary intervention with implantation of a     self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria     were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were     defined.      Primary end-point of the study is the occurrence of MACE (death, myocardial infarction, stent     thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization).     Secondary end-points include individual components of MACE, procedural complications     (periprocedural MI, bleedings, access site complication, failure to cross stent struts with     guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced     nephropathy), bleedings at follow up.   "
38295|NCT02784392|"     The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral     feeding intolerance.   "
38296|NCT02784379|"     Mastalgia is a common problem for women. The aim of this study is to investigate the role of     neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.   "
38297|NCT02784366|"     The purpose of this study is to establish a prospective observational cohort of cancer     immunotherapy patients with GI side effects in order to identify biomarkers that predict GI     complications due to treatment.   "
38298|NCT02784353|"     Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP     Malignancy.   "
38299|NCT02784340|"     A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in     Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants     were scheduled for elective cesarean section under spinal anaesthesia and were randomly     divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II     (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section     scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline     infusion. All cases were followed up for 48 hours for assessment of level of pain by using a     10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for     additional analgesics. Other parameters were hemodynamic changes and occurrence of side     effects or complications   "
38300|NCT02784327|"     PRF110 is new extended release oily solution formulation of ropivacaine that is intended for     local infiltration into surgical wounds. The purpose of this study is to determine the safety     and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic profile     of PRF110 over 72 hours and evaluate the duration of analgesia witnessed in the surgical     setting.   "
38301|NCT02784314|"     In this observational cost efficacy study, the investigator compare the Laparoscopic Radical     Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of     care that include hospitalization related or post operative medical consumption are obtained     and recorded up to 5 years follow up. Functional results (continence, potency, quality of     life) are obtained through standardised questionnaires. Carcinologic results are estimated by     Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be     made to estimate direct costs of the four postoperative year along with the incremental     cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary     continence and erectile function and PSA < 0.2).   "
48090|NCT02656160|"     In this protocol the investigators will test the effect of dalfampridine (a potassium channel     blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy     control subjects.   "
38302|NCT02784301|"     Belly breathing is a popular relaxation technique used to reduce anxiety and pain in children     during medical procedures. The investigators have developed a biofeedback game that will help     teach children how to belly breathe in an interactive way. Existing studies have shown that     biofeedback tools are effective ways to teach relaxation techniques to children. The purpose     of this study is to evaluate 1) whether this new biofeedback tool is a more a effective and     engaging way to teach belly breathing to children and 2) whether the application is more     effective in reducing procedural pain and anxiety compared to standard of care, self-directed     belly breathing alone or self-directed belly-breathing combined with visual distraction. The     investigators hypothesize that:        1. The smartphone-based biofeedback game for belly breathing will reduce self-reported          procedural anxiety and pain in children during a blood collection procedure compared to:             1. standard of care             2. belly breathing + standard care procedures             3. belly breathing with visual components of the application with no coaching or               biofeedback distraction.        2. The smartphone-based biofeedback game will increase compliance with belly breathing          compared to self-directed breathing.        3. Belly breathing with smartphone-based biofeedback game will be more engaging compared to          self-directed belly breathing.   "
38303|NCT02784288|"     Investigators will determine whether treatment stratification by neck dissection, to more     accurately pathologically stage patients, minimizing the number of treatment modalities in     patients with low risk oropharyngeal squamous cell carcinoma, can improve quality of life.   "
38304|NCT02784275|"     This is a double-blind, randomized, placebo-controlled, parallel-group comparison study to     evaluate the efficacy and safety of Cyclo-Z for the treatment of subjects with obese type 2     diabetes.      The study will consist of 3 phases:        -  Screening phase (2 weeks)        -  Treatment phase (12 weeks)        -  Follow-up phase (2 weeks)      Following a 2-week screening period, subjects who meet all inclusion and exclusion criteria     will be randomly assigned into one of the following treatment arms:        -  Dose A: Cyclo-Z containing 23 mg zinc plus 3 mg CHP - 16 subjects        -  Dose B: Cyclo-Z containing 23 mg zinc plus 9 mg CHP - 16 subjects        -  Dose C: Cyclo-Z containing 23 mg zinc plus 15 mg CHP - 16 subjects        -  Dose D: Placebo - 16 subjects      The assigned dose will be orally administered to subjects once a day before bedtime for 12     consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their     respective trial sites at Weeks 2, 4, 6, 8, 10, 12, and 14 (Visits 3, 4, 5, 6, 7, 8, and 9).   "
38417|NCT02782767|"     Comparison of efficacy in management of pain in abdominal surgery between epidural versus     wound infusion catheter {catheter placed within the incision site}   "
38305|NCT02784262|"     Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic     rhinosinusitis in several ways. Patients have significantly more severe symptom burden and     worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many     patients return to the health care providers with persistent symptoms after repeated medical     and surgical treatment. Patients have usually tried several different types of treatments,     ranging from less invasive procedures to extensive surgical treatment. The surgical treatment     is often repeated several times. The most common surgical treatment is functional endoscopic     sinus surgery, another established procedure is Vidian neurectomy.      The main object of this pilot study is to investigate the safety of onabotulinumtoxin A     towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data     will also be collected to provide indication on whether future placebo-controlled studies     should be performed.      Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic     reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling,     secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9     months and will not lead to damage of the nerve.      This study opens up for improved treatment with less complications.   "
38306|NCT02784249|"     The purpose of this study is to compare the safety and efficacy of goniotomy performed with a     novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate     glaucoma subjects who are also undergoing cataract extraction with phacoemulsification     (Phaco) and posterior chamber intraocular lens (PCIOL) implant.   "
38307|NCT02784236|"     Prospective study of 6 months of evolution in people with type 1 diabetes with insulin     multidose (MDI) and HbA1c> 7%. Patients were evaluated clinical, metabolic and psychological     baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control     (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI),     treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R),     quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.   "
38308|NCT02784223|"     The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the     diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication     of surgical resection.   "
38309|NCT02784210|"     Background:      Multiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can     appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up     from the outer edge and fill inward. This is called ring enhancement. Researchers think this     type of lesion may not heal as well as others. Corticosteroids are the standard treatment to     reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing     MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose     course of corticosteroids helps heal those lesions.      Objective:      To study the effects of short-term high-dose corticosteroids on ring-enhancing MS.      Eligibility:      Adults ages 25 and older who:        -  Have MS and a rim-enhancing lesion on a prior brain MRI        -  Are enrolled in another NINDS protocol      Design:      Participants will be screened under another protocol      Participants will be randomly assigned to get either no treatment or 3 days of treatment with     a corticosteroid.      Participants will have:        -  1 baseline visit        -  3 dosing visits over 3 days if assigned to get treatment. Participants will get          methylprednisolone by IV each day. They will get medicine to protect their stomach.        -  1 visit each month for 7 months      Visits include medical history and physical exam. Participants will have blood and urine     tests. Participants will also have neurological exams and MRIs. Participants lie on a table     that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a     catheter: A needle guides a thin plastic tube into an arm vein.   "
38310|NCT02784184|"     Minipuberty is a term used to describe the transient activation of the pituitary-gonadal axis     2-3 months after birth in both boys and girls. It is, however, not known why infants reach     adult levels of reproductive hormones in early life, nor is the exact timing of the peak     known. Furthermore, what determines the timing of peaks and suppressions of reproductive     hormones from infancy throughout childhood and into adolescence remains to be elucidated.      The study aims to described and evaluate dynamic changes in the hypothalamic-pituitary-     gonadal axis in early postnatal life.   "
38311|NCT02784171|"     Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show     that this drug works by helping improve the body's immune response to help fight cancer.     Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth     and/or spreading of cancer.   "
38312|NCT02784158|"     The purpose of this study is to provide brigatinib for those patients with locally advanced     and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability     to meet eligibility criteria for on-going recruiting trials, inability to participate in     other clinical trials (e.g., poor performance status, lack of geographic proximity), or     because other medical interventions are not considered appropriate or acceptable.   "
38313|NCT02784145|"     The investigators will investigate the effects of an 8-week resistant starch (RS)     supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:        1. symptoms of constipation (assessed by clinical scores);        2. fecal short chain fatty acid concentrations (measured by chromatography);        3. gut microbiota composition.   "
38314|NCT02784132|"     Fundoscopy is an important component of the neurological examination as it can detect     pathologies such as high intracranial pressure. However, the exam can be challenging in     uncooperative children. This study looked at whether playing a video during eye examination,     improves the success, duration and ease of pediatric fundoscopy.   "
38356|NCT02783586|"     The main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis     Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic     agent to the paravertebral space. It may produce extensive analgesia and better pain control.      Previews studies shoved the effectiveness of TAPB in kidney transplantation procedure (KTX)     by reducing opioids requirements during and after the operation. QLB was not evaluating in     KTX procedure yet, but it reduced postoperative morphine requirement after cesarean section     under spinal anaesthesia.      The aim of this prospective, randomised controlled, multicenter, clinical study is to compare     the perioperative analgesic efficacy of QLB and TAPB in patients who had KTX under balanced     (general and regional) anaesthesia.   "
38315|NCT02784119|"     The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and     endstage liver disease has led to an increase in the gap between patients on waiting-lists     and available liver grafts. In order to compensate for this scarcity, use of liver grafts     harvested from extended criteria donors (ECD) has become more and more frequent.      However, these ECD grafts are known to be associated with a higher rate of primary non     function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to     ischemia-reperfusion injury (IRI).      During OLT, the clamping of the portal vein induces blood congestion in the splanchnic     territory leading to increased gut permeability, bacterial translocation and release of     endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI.      Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between the     portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic     congestion and could therefore decrease IRI and improve liver graft function. However, TPCS     remains poorly used as no randomised trial succeeds to show its benefit on liver function due     to lack of power.   "
38316|NCT02784106|"     M2951 is an investigational drug under evaluation for treatment of autoimmune and     inflammatory disorders. The purpose of the study is to assess the efficacy of M2951 in     subjects with rheumatoid arthritis (RA) currently treated with stable dose of methotrexate     (MTX).   "
38317|NCT02784093|"     Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is     the result of chronic or severe constipation and most commonly found in the elderly     population. Gastrografin is a water soluble contrast mediate that could act as an osmotic     laxative. It has been shown to confer a therapeutic beneﬁt in adhesive small bowel     obstruction (SBO). The investigators speculate that gastrografin administrated orally may be     more effective than enema in the treatment of fecal impaction induced intestinal obstruction.   "
38318|NCT02784080|"     The aim is to evaluate the impact of donor specific HLA alloantibodies (DSA) on all-cause     mortality and re-transplantation, early allograft dysfunction, acute and chronic rejection,     fibrosis, vascular, and biliary complications. Furthermore, all biopsies will be C4d stained.     The hypothesizes is that donor specific HLA alloantibodies facilitate an immune mediated     damage to the liver allograft that impairs function and lead to various complications.      The investigators will do a prospective blinded multicenter cohort study in the     Scandiatransplant organ sharing organization region.      Both preformed, persistent, and de novo donor specific HLA alloantibodies will studied. Blood     samples will be taken immediately prior to transplantation, and 14 days, 3 months, and 1 year     after transplantation. All liver biopsies performed during the study period will be evaluated     for a humoral component and blood samples will be obtained prior to liver biopsies to     investigate the presence of DSA.      Investigations will be fully blinded for the treatment responsible doctors.   "
38319|NCT02784067|"     S09A is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study     examining the efficacy and safety of a Sucraid (sacrosidase) Oral Solution in comparison to a     placebo in 150-200 subjects with chronic diarrhea possibly attributable to sucrase     deficiency.   "
38320|NCT02784054|"     The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ     cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and     autologous stem cell transplantation (HDCT/auto-SCT).   "
38321|NCT02784041|"     The purpose of this study is to compare the effect of single adductor-canal-block versus     single femoral nerve block on the recovery after total knee arthroplasty.   "
38452|NCT02782299|"     This is a study to investigate the use of a Decision Aid for shared decision making in older     adults with distal radius fractures. The goal is to improve patient decisions making, and     improve patient knowledge through the use of a validated decision aid.   "
38322|NCT02784028|"     The digestive cancer is the second cause of death worldwide. The presence of peritoneal     carcinomatosis is common in the evolution of this type of cancer, as well as increased levels     of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low     sensitivity detection means.      In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as     possible associated with an intraperitoneal chemotherapy gave better results but still     failures associated with the presence of microscopic residual tumors.      The use of SGM -101 (developped by SURGIMAB SAS) allows surgeons to detect tumor nodules of     small size very easily, in real-time, during surgery (shown in animals).   "
38323|NCT02784015|"     To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based     treatment   "
38324|NCT02784002|"     The purpose of this research study is to evaluate the safety and effectiveness of     Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).   "
38325|NCT02783989|"     The present study will assess whether the beneficial effects of a market moderate-alcohol     drinking in the form of white wine in humans could be derived from the endogenous formation     of hydroxytyrosol (also known DOPET), a potent dietary anti-inflammatory and antioxidant     molecule.   "
38326|NCT02783976|"     This study will collect and evaluate information on the safety and efficacy of Sovaldi-based     regimens in routine clinical practice in Mexico. The primary objective of this study is to     assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse     events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV)     infection treated with Sovaldi in routine clinical practice.   "
38327|NCT02783963|"     The purpose of this study is to evaluate the prevalence and morphological features of     coronary plaques by means of OCT in patients with acute myocardial infarction but without any     significant coronary stenosis at coronary angiography. In addition, cardiac magnetic     resonance imaging (CMR) will be performed to assess the prevalence, location, and pattern of     myocardial injury as well as other concomitant findings. As a secondary analysis, the     association between the distribution and characteristics of coronary plaques detected on OCT     and myocardial injury shown by CMR will be evaluated. In addition, a post-hoc survey     regarding the potential modification of the interventional treatment approach based on OCT     analysis will be conducted.   "
38328|NCT02783950|"     To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk     post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to     clinical factors alone.   "
38329|NCT02783937|"     Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug.     Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed     that these cells are able to regenerate the affected ovary. Studies on mice have shown that     Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in     2013, 2014, and 2015).   "
38332|NCT02783898|"     Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near     blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is     difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and     symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an     abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients     are usually discharged with advice to return to the ED again for a 12-lead ECG should     symptoms recur. The investigators will recruit 242 adult participants to either study or     control arms. All study arm participants will be given an AliveCor Heart Monitor and trained     in the use of the device. Control arm participants will receive standard care only. Both     groups will be followed-up at 90 days. The investigators believe a smart phone based event     recorder will allow better and earlier diagnosis in patients with a compatible smart phone or     tablet, and revolutionise ED care in this area.   "
38333|NCT02783885|"     The efficacy and safety of different medications vary from one individual to another and from     one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and     pharmacoepidemiology has evolved recently.      There are multiple examples of oncology drugs being more effective in certain ethnic     population compared to other. For example, irinotecan combined with cisplatin was very     effective drug in the management of small cell lung cancer in the Japanese patients while an     identical study done in the US revealed no major benefit to this combination in American     population   "
38334|NCT02783872|"     This study will investigate neural activation patterns in emotion- and cognition-related     brain regions during an emotion regulation task involving cognitive reappraisal, and their     associations with age and pubertal status, among overweight children and adolescents with     loss of control eating as compared to overweight and normal-weight controls.   "
38335|NCT02783859|"     An intervention study to determine if a longer duration of antibiotics (compared to shorter     duration) improves the short and long term clinical outcomes of children hospitalised for     pneumonia   "
38336|NCT02783846|"     The purpose of this study is to evaluate the effects of different dexmedetomidine on the     propofol requirement for loss of consciousness undergoing bispectral index.   "
38337|NCT02783833|"     Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P.     falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria     (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P.     falciparum (Part B).   "
38338|NCT02783820|"     This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of     escalating single doses of reformulated MMV390048 when administered to healthy men and women     of non-childbearing potential (WNCBP) under fasted conditions (Part A).   "
38339|NCT02783807|"     This prospective equivalency study compares the performance of two Ophthalmic Cameras, the     Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained     technicians will take pictures of the same patients' retinas and the quality of the photos     will be evaluated. The study includes healthy patients and patients with a spectrum of     retinal diseases. The study requires that technicians take pictures of the retinas of adult     patients between 18 and 80 years of age using both the OC and OP. The pictures will be     reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is     equivalent to the OP, based on the quality of the images   "
38341|NCT02783781|"     In cardiac surgery, the assessment of operative risk and quality of care is a major challenge     for both patient, and surgical team. It is also important for health care decisionmakers to     have predictive tools to compare alternative technics such as conventional cardiac surgery     and interventional cardiology. Since 1998, the European System for Cardiac Operative Risk     Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most universally used system in     this purpose. Its success is the result of a good balance between predictive capability and     simplicity. It consists almost exclusively of clinical variables.      However, the objectivity and the predictive ability of some of those clinical items remain     controversial, particularly those addressing severity of illness for high-risk patients. For     instance, the degree of priority is submitted to the subjective assessment by the surgical     team at the time of surgery. Objective data describing the severity of patients arriving in     the operating room are still missing.      Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH),     heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I),     respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal     impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen,     CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and     nutritional status (albumin).      In ICU, many scores use biological data to measure, on daily basis, the severity of the     patient status. Their routine use is simplified by applications available on smartphones.     They are drawn into hospital information systems.      In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative     biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is     of particular interest because it detects underlying diabetes if unknown (emergent situation)     or reflects its poor control before surgery. This criterion could be more reliable than the     simple information of patient treated by insulin (EuroSCORE II criterion).      Finally, the reinforcement of existing scores with biological variables is recommended by the     group of recommendations in prognostic research strategy (PROGRESS 2014), rather than     creating new scores ex nihilo.      The hypothesis is that adding biological data collected at the time of arrival of the patient     in the operating room would better qualify the patients' severity condition and therefore     increase the risk prediction of early mortality and severe morbidity after cardiac surgery.     The purpose of this study is to test this hypothesis and especially test whether the     biological data would increase the EuroSCORE II performance, by improving the prediction for     high-risk patients.   "
38342|NCT02783768|"     Determination of the acute pulmonary toxicities of e-cigarettes in young adults is of major     public health importance, as e-cigarette vapor contains established toxicants that as     hypothesized cause acute damage to the airways and the pulmonary microvasculature that may     promote the development of CLD, for which there remain few effective therapies.      The study therefore propose a pilot study using a randomized crossover design in ten healthy     young adults to test the acute effects of a standardized e-cigarette exposure on two     sensitive, safe, non-invasive imaging measures: (1) ventilation defects on hyperpolarized     helium-enhanced magnetic resonance imaging, and (2) pulmonary microvascular blood flow on     gadolinium-enhanced pulmonary magnetic resonance angiography.   "
38357|NCT02783573|"     The main purpose of this study is to evaluate the efficacy of the study drug known as     lanabecestat in participants with mild Alzheimer's disease (AD) dementia.   "
38418|NCT02782754|"     The purpose of this study is to evaluate the outcome of intracranial germinoma treated with     chemotherapy plus reduced radiotherapy.   "
38343|NCT02783755|"     The purpose of this study is two-fold. First, the investigator will develop a low-literacy     Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e.,     therapist manual, patient manual including handouts, and the smartphone materials) as well as     a beta version of the basic smartphone components with the assistance of experts in the     field. Next, an iterative development design using focus groups with women who have breast     cancer and pain accrued from medically underserved areas will be used to refine the developed     mPCST protocol and basic smart phone components. The protocol—designed to reduce cancer pain     and disability in patients with low literacy in medically underserved areas—will be delivered     via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g.,     simple text messages, images, and preloaded intervention content) will allow the intervention     to extend into the patients' homes. The second study purpose is to pilot test the     feasibility, acceptability, and efficacy of the developed protocol. The investigator will     also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus     group data will be managed and evaluated in a systematic format using a grounded theory     approach. Data analyses for the pilot testing period of the study will be assessed by     examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used     to examine pre- to post-intervention differences in pain and the other outcomes of interest.     There are minimal risk or safety issues related to this study.   "
38344|NCT02783742|"     To examine the effect of a coaching intervention on provider burnout and communication   "
38345|NCT02783729|"     The primary objective of this study is to demonstrate using polysomnography (PSG) that 10 mg     lemborexant is superior to zolpidem tartrate extended release 6.25 mg (Ambien CR®) on     objective sleep maintenance as assessed by wake after sleep onset in the second half of the     night (WASO2H) after the last 2 nights of treatment in participants 55 years and older with     insomnia disorder.   "
38346|NCT02783716|"     The goal of this study is to determine the role of vascular endothelial function in heart     failure (HF) and the effect of cardiac resynchronization therapy (CRT) on endothelial and     cardiac function.   "
38347|NCT02783703|"     The study team will investigate the racial differences in the metabolic and clinical     responses to Medium chain triglycerides (MCT) between African American and Caucasian American     subjects with Metabolic Syndrome.   "
38348|NCT02783690|"     This is an open label phase II randomized controlled trial to determine the safety of 15     fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients     requiring regional nodal irradiation. Proton therapy is recognized as a standard option for     the delivery of radiotherapy for breast cancer.   "
38363|NCT02783495|"     This pilot trial of this iPad-based intervention in glioma patients at University of     California, San Francisco (UCSF) will establish feasibility and preliminary efficacy data to     support a funding application for a larger clinical trial. Twenty patients with stable     low-grade gliomas will complete a computerized battery of standardized neurocognitive tests     and quality of life assessments at baseline. Subjects will complete the intervention at home     over 3 months. Neuro-cognitive testing will be repeated 3 and 9 months after baseline.     Subjects will also complete a post-intervention questionnaire on the usefulness,     attractiveness, difficulty and burden of the intervention. Clinical data will be collected at     the time of each assessment. This will include diagnostic and treatment history, magnetic     resonance imaging (MRI data), tumor genomics and immunohistochemistry.   "
38364|NCT02783482|"     The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune     Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).   "
38349|NCT02783677|"     Peripheral artery disease (PAD) is highly prevalent. It occurs most often in the lower     extremities. Symptoms include intermittent claudication, ischemic pain, ulceration and     necrosis. Amputation may be necessary in severe cases. PAD is also an indicator of future     cerebrovascular and cardiovascular events. Diabetes mellitus (DM) is one of the major risk     factors of PAD. Approximately 5% to 10% of diabetic patients have had foot ulceration, and 1%     have undergone amputation. Other risk factors include smoking, old age, male gender,     hypertension, dyslipidemia, hyperhomocysteinemia and renal insufficiency. Ankle-brachial     index (ABI) is the most popular tool used to screen PAD. Doppler-derived ankle and brachial     systolic pressure is obtained. If the ratio is abnormal, further confirmation studies will     necessary. Although ABI is recommended as one of the screening tests for diabetic     complications in guidelines, its utility is limited in calcified non-compressible vessels,     which are common in DM and renal failure patients.      Digital infrared thermal imaging (DITI) is used to detect surface temperature because objects     of absolute temperatures higher than zero would radiate electromagnetic waves of certain wave     lengths according to Plank's law. DITI examination is non-invasive, non-contact and fast.     Theoretically, temperature of the perfusion area of the occlusive arteries will decrease.     Investigators will analyze DITI of PAD, and observe the relationship between DITI, ABI and     vascular duplex examination. The dynamic change of DITI before and after percutaneous     transluminal angioplasty of PAD will also be observed. Investigators would like to evaluate     the possibility of the clinical application of DITI for PAD screening.   "
38350|NCT02783664|"     This prospective Medical College of Wisconsin Cancer Center study will evaluate stress levels     in breast cancer patients undergoing genetic testing. It aims to establish baseline stress     levels, evaluate pre- and post-test stress levels at multiple time points, focus on the     changes in stress levels for the different resulting subgroups. This will help the clinical     staff to provide better care for patients both medically and psychologically through     potential interventions to decrease stress.   "
38351|NCT02783651|"     A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in     the US.   "
38352|NCT02783638|"     This study is to assess the pharmacokinetics of Pregabalin controlled release formulation     after multiple dosing as compared to Pregabalin immediate release formulation and the food     effect of high fat diet after single dosing in healthy male volunteers.   "
38353|NCT02783625|"     The purpose of this study is to test the safety of a study drug called duvelisib.   "
38354|NCT02783612|"     Assessing blood glucose control in women with gestational diabetes can be challenging. The     standard of care remains visual inspection of blood glucose paper diaries of self-performed     capillary monitoring during regular meeting in High Risk pregnancy clinics.      The researchers are interested in preforming a randomized control trial comparing women with     the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital     monitoring using an application in a Smart-phone and submitting those values via email in     addition to the regular clinic appointments.      The Primary outcome of the trial is to assess the compliance of the research group as     compared to the control group.   "
38355|NCT02783599|"     The purpose of this study is to evaluate potential biomarkers and method of action, efficacy     and safety of olaratumab in participants with soft tissue sarcoma (STS).   "
38401|NCT02782988|"     CMV lesions were found in the olfactory system of children with congenital CMV infection but     no study has hitherto examined the impact of congenital CMV infection on olfaction. So the     investigators propose in this study to assess the proportion of children with olfactory     deficits among children with congenital CMV infection. Second this study will also evaluate     performances of a new olfactory test, based on discrimination of binary odorant mixtures.   "
38358|NCT02783560|"     Despite the high prevalence of sleep difficulties in children with disruptive behavior     disorders, little is known about the role of sleep in treating disruptive behavior. The     current study evaluates the addition of a sleep intervention to an existing parent-training     program for caregivers of children ages 3-8 with disruptive behaviors. Objectives are to     examine the impact of a novel sleep treatment program on sleep, disruptive behavior, and     other measures of family functioning, utilizing a variety of self-report and objective     measures (e.g. actigraphy, electrodermal activity). The investigators hypothesize that sleep     intervention will result in improvements in sleep and disruptive behavior compared to control     group receiving a highly plausible addition to the standard parent training intervention, and     that sleep outcomes will moderate overall treatment success.   "
38359|NCT02783547|"     This is a Phase 1 clinical trial to evaluate the tolerability of a combination therapy of SyB     C-1101 (rigosertib sodium) and Azacytidine and to determine the recommended dose of SyB     C-1101for Phase 2 trial in patients with myelodysplastic syndrome.   "
38360|NCT02783534|"     Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal     anti-inflammatory drug is an effective treatment, there are concerns about serious adverse     events. Complementary therapies, including acupuncture, are commonly used for PD. Acupuncture     has a low risk of adverse effects, while the evidence for the effectiveness of acupuncture in     treating PD is inconclusive. Deqi and psychological factors are core concepts in acupuncture     theory, but they have been largely neglected in primary dysmenorrhea clinical reports. The     objective of this trail is to assess the clinical efficacy of acupuncture in the prevention     of PD and investigate what factors will affect the efficacy of acupuncture.The results of     this trial will significantly add to the current body of evidence on the role of acupuncture     for PD. If found to be effective and safe, acupuncture will be a valuable treatment option in     the prevention of PD. In additional, results from this trial will identify what factors will     affect the efficacy of acupuncture.   "
38361|NCT02783521|"     The investigators propose to 1) assess the feasibility, acceptability and preliminary     efficacy of a gender- and culturally-sensitive weight loss intervention in 48     overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant     characteristics and process measures related to the uptake of mobile-health (mHealth)     technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes     in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a     non-invasive MRI as a therapeutic response biomarker.   "
38453|NCT02782286|"     The study is prospective, double blinded, randomised controlled and has the purpose to     compare the analgesic effects of ketorolac or morphine intravenous in low back pain.   "
38365|NCT02783469|"     In 1997, the global prevalence of diabetes was estimated to be 125 million and this has risen     to around 400 million in 2015. In addition diabetes has a number of complications including     heart disease, blindness, kidney failure and amputation. This represents a significant burden     on healthcare services. Type 2 diabetes (T2D) is caused by a combination of genetic and     environmental factors. The aim of GoDARTS is to recruit participants with T2D to a registry     to provide a platform with which to investigate the genetics of T2D, its complications and     response to treatment. This study will investigate the genetic basis of diabetic neuropathic     pain.   "
38366|NCT02783456|"     Epidemiological studies have found a link between aircraft noise exposure and increased     incidence of arterial hypertension and thus cardiovascular disease. The underlying     pathophysiological mechanisms are not yet fully understood. The kidney acts as a long-term     regulator of blood pressure and controls the extracellular sodium and water balance.     Significant renal mechanisms of blood pressure regulation are the renin angiotensin system,     renal sympathetic activity and sodium excretion. Animal work and clinical studies show that     mental stress affects the renal plasma flow and urinary sodium excretion. The investigators     observed a lower sodium excretion in situations of mental stress in subjects at risk for     developing arterial hypertension. In healthy volunteers, a 30-minute mental stress test     resulted in increased glomerular filtration rate, filtration fraction and an increase in     urinary sodium excretion. In this pilot study the investigators analyzed the influence of 30     minutes standardized aircraft noise on renal and central hemodynamics.   "
38367|NCT02783443|"     Observational study evaluating effect general or regional anaesthesia on glycocalyx by using     perfused Boundary Region in sublingual microcirculation.   "
38368|NCT02783430|"     KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant     action of ketamine in palliative care situations. Half of participants will receive Ketamine     and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran     in combination.   "
38402|NCT02782975|"     The primary objectives of this study are to evaluate the absolute bioavailability of a     single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based     intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK)     profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability     of aducanumab administered via SC and IV routes in healthy participants and to characterize     additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose     in healthy participants.   "
38369|NCT02783417|"     The use of antiretroviral therapy (ART) could prevent depression of the immune system of     patients harboring with Human Immunodeficiency Virus (HIV), providing increased life     expectancy, changing the classification of HIV / AIDS into a chronic illness. However     prolonged use of ARTincreases the prevalence of lipodystrophy syndrome (SL), characterized by     inadequate distribution of body fat and changes in lipid profile, associated with a     significantly increased cardiovascular risk, among others. The practice of strength training     (ST) helps in controlling SL, providing improved lipid profile and the quality of life of     these patients. However, due to increased cardiovascular risk and physical weakness resulting     from SL, the ST with vascular occlusion (STOV) could be a viable alternative training, to use     low load (10-30% of maximal work capacity) with similar benefits ST traditional (STT), as     already proven in other populations. The STOV is justified by the lower neuromuscular     overhead, increasing the number of patients able to participate in this complementary     therapy. The objective was to assess the impact of the combined strength training with     vascular occlusion on SL and the skeletal muscle tissue in people harboring with HIV/Aids.   "
38370|NCT02783404|"     Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at     risk of infective endocarditis, expert committees continue to publish recommendations for     antibiotic prophylactic regimens. Recently, the investigators have evaluated the efficacy of     the intravenous administration of 1000/200 mg of amoxicillin/clavulanate for the prevention     of bacteraemia following dental extractions. The results of this study suggest that is highly     effective, and that it might be considered a first-line choice for patients at high-risk for     infective endocarditis who undergo dental procedures and for whom antimicrobial prophylaxis     is recommended. This new project aims to evaluate the effectiveness of oral     amoxicillin/clavulanate in preventing post-dental extraction bloodstream infection.   "
38371|NCT02783391|"     New method for speech area cartography in patient individual cortical anatomy in view of     improving functional area limit preservation during surgery.   "
38372|NCT02783378|"     At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours.     During the first 24 hours are the measurements without medication. After 24 hours the     treatment will be started with Gaviscon and will the next 24 hours the measurements under the     medication happen. Normally is the medication required after the measurements. With this     study the investigators will have multiple measurement points to compare.   "
38373|NCT02783365|"     There are an estimated 100 million Americans with chronic pain. The enormity of the problem     at the societal level is staggering, not simply in terms of its sheer prevalence but also the     societal costs, including health care expenditures, disability compensation, lost     productivity, and lost employment potential. The pharmacological focus in treatment tends to     give patients with chronic pain a negative stereotype as many are viewed as drug seeking, or     worse, they are perceived to have an imaginary illness. It is argued that these stigmas not     only negatively affect the patients' healthcare experience, but also perpetuate maladaptive     coping. In addition, it is suggested that reliance on pharmacological approaches have     contributed to the rate of overdoses from prescribed opioids. In order to address this burden     facing society, patients need opportunities to foster a sense of self-efficacy to manage     their pain, as well as improve their healthcare experience by allowing them to dialogue with     their clinician openly and freely about their chronic pain, and coping strategies.      This study is designed to explore the impact of an intervention using photo-elicitation     (based on Photovoice) and online group support (via Facebook) on participants' overall     experience of chronic pain and patient-identified areas of function. Photovoice participants     will utilize cameras that enable them to record issues related to their experiences, and     subsequently display them. This method serves as an empowering tool to connect participants     to key stakeholders in the community, facilitates change and opportunities that otherwise     would not be available to marginalized groups.   "
38374|NCT02783352|"     Increasing the success rate of rotator cuff healing remains a tremendous challenge for     orthopedic surgeons, which encourage the development of new biological therapies. Among many     approaches, activating resident progenitor cells with the Lipogems® product could be an easy,     safe, practical and cost-effective new therapeutic strategy for increasing rotator cuff     tendon healing.      The primary goal of this study is to evaluate efficacy of infiltration of autologous     micro-fragmented adipose tissue in arthroscopic rotator cuff repair, in terms of gain in     post-operative Constant score.   "
38375|NCT02783339|"     The primary objective of this study is to demonstrate effectiveness and safety of the     NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial     aneurysm treatment.   "
38376|NCT02783326|"     Chronic obstructive pulmonary disease (COPD) is a condition in which the lung is in chronic     state due to an inflammatory response that leads to limitation in lung function of the     individual, providing symptoms such as dyspnea, nutritional changes, decreased strength     respiratory muscle, low capacity to exercise, dynamic insufflation and altered autonomic     function with decreased heart rate variability. Have objective to evaluate and compare the     effects of a rehabilitation protocol on autonomic modulation of heart rate. Participate in     the study, 10 volunteers with COPD and 10 apparently healthy individuals, of both sexes,     between 50 and 70 years old. Data collection and application of the Protocol will take place     at the Clinical School of Physiotherapy and Occupational Therapy at the University of the     Amazon (UNAMA). Between January and February 2015.   "
38377|NCT02783313|"     The objective of this study is to determine if pooled buffy coat-derived pathogen reduced     plasma-stored platelet concentrates are non-inferior compared to plasma-stored platelet     concentrates in terms of WHO bleeding complications in hemato-oncological patients with     thrombocytopenia.   "
38403|NCT02782962|"     This study evaluate the diagnostic accuracy of a simplified clinical algorithm (STANDING) for     the differential diagnosis of acute vertigo in the emergency department.      In particular, the investigators want to analyze the sensitivity and specificity of the test     for the diagnosis of vertigo of central origin and the reproducibility of the test.      In suspected central vertigo of ischemic origin, a duplex sonography to identify vertebral     artery pathology will be performed.   "
38378|NCT02783300|"     The study drug, GSK3326595, is an inhibitor of protein arginine methyltransferase 5 (PRMT5)     that potently inhibits tumor growth in vitro and in vivo in animal models. This first time in     human (FTIH), open-label, dose escalation study will assess the safety, pharmacokinetics     (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in subjects with     advanced or recurrent solid tumors, as well as clinical activity in subjects with a subset of     solid tumors and non-Hodgkin's lymphoma. This is an open-label, repeat-dose, multicenter,     2-part study to establish the maximally tolerated dose (MTD)/ recommended phase 2 dose (RP2D)     based on safety and tolerability and preliminary clinical efficacy of orally-administered     GSK3326595. Part 1 is a dose-escalation phase to identify the MTD/RP2D based on the safety,     PK, and PD profiles observed after oral administration of GSK3326595. This Part will be     conducted in adult subjects with relapsed and/or refractory solid tumors. It is estimated     that up to 50 subjects will be enrolled into the dose escalation cohort of the study,     including up to 38 subjects to identify the MTD and approximately 12 subjects in the     PK/PD/metabolite/biomarker expansion cohort(s). Disease-specific expansion cohorts (Part 2)     are planned to further explore clinical activity of GSK3326595 in subjects with selected     solid tumors and non-Hodgkin's lymphomas. It is estimated that up to 150 subjects will be     enrolled in the disease-specific expansion cohorts of the study. The duration of study will     depend on recruitment rates and the timing of subjects' duration on study (withdrawal rates     due to toxicity or progression), with an approximate duration of 2 years.   "
38379|NCT02783287|"     The purpose of this study is to assess the impact of text message reminders on adherence to     medications and exercise in patients recently discharged from the hospital after a myocardial     infarction (MI).   "
38380|NCT02783274|"     Two-year (2 year) information regarding the performance of the commercially available Actis™     Total Hip System in order to obtain and evaluate the clinical outcomes on a series of     cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty procedures using     clinical, radiographic and device and procedure related adverse event assessments.   "
38381|NCT02783261|"     Patients undergoing Y90 radioembolization to will be followed prospectively with CT volumetry     to determine post-Y90 rate of liver hypertrophy.   "
38382|NCT02783248|"     The aim of this study is to validate prospectively the predictive score of late results about     a diverse population recruited in France and to evaluate the contribution in predicting the     outcome of the PMC scanner to study the mitral calcium score and the location of the     calcifications.   "
38383|NCT02783235|"     This study aims at creating video-based tutorials for developing skills in performing     cervical cancer screening using VIA for the Auxillary Nurse Midwives (ANMs), Accredited     Social Health Activists (ASHAs) and Primary Health Workers (PHWs). Cervical cancer screening     is mainly done by the following three methods: Visual inspection with acetic acid (VIA),     Cervical Smear Cytology (PAP) and HPV DNA test. VIA is a low cost, low resource cervical     cancer screening method and especially useful for low middle income countries (LMICs) like     India.      We propose to develop video-based tutorials, such that the ANMs/ASHAs/PHWs could be trained     in performing and interpreting VIA with the use of this tutorial. The ANMs/ASHAs/PHWs have     important roles in delivering health in rural/ semi urban areas and they will be trained     using this tutorial.      The video-based tutorials will be made according to the 'Spoken Tutorials' methodology,     developed at IIT Bombay. Video-based Tutorials has given skills based training to over 2 lakh     students in the past four years on IT based topics. The tutorials are made available online     free of cost. They are designed to be used without the need of an expert being physically     present.   "
38384|NCT02783222|"     This is a randomized study evaluating the efficacy and impact on function of two different     doses of nab-Paclitaxel in elderly patients with advanced breast cancer.   "
38385|NCT02783209|"     This study evaluates the association between surgery of the cataract and posterior vitreous     detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in     the same group of patients   "
38386|NCT02783196|"     This study is undertaken to search whether glucagon-like peptide-1 (GLP-1) analogue,     Liraglutide, by enhancing clock gene and AMPK-SIRT-1 mRNA expression, may reverse the     metabolic abnormalities of type 2 diabetes, improving overall glycemic excursion,     inflammatory cytokines and β-cell function in type 2 diabetes individuals.      The investigators aim is to compare the effect of 40 days treatment with Liraglutide (LIR)     vs. 40 days with placebo (PLA) in T2D participants on the following end points:      Primary end-points:        -  Change in the oscillation of CG (i.e. CLOCK, BMAL1, Per1, Per2, Cry1, Cry2,          Rev-erb-alpha Ror-alpha), AMPK, SIRT1 and inflammatory cytokines mRNA expression in          white blood cells (WBCs).      Secondary end-points:        -  Overall daily glycemic variation assessed with continuous glucose monitoring system          (CBMS)        -  Serum levels of inflammatory cytokines (TNF-α, IL-1β, IL-6)        -  β-Cell function derived from glucose and insulin response to OGTT   "
38387|NCT02783183|"     The purpose of this trial to compare the pharmacokinetic characteristics of     YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release     formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and     secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.   "
38388|NCT02783170|"     This is a pilot, prospective, randomized, open-label clinical trial. During the study,     pregnant women will be randomized (1:1) to receive co-administration of a single     intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a     single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria     toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the     vaccines (IIV followed by Tdap ~ 21 days later). Vaccines will be administered by licensed     study personnel.      Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when     possible.      Injection-site (local) and systemic reaction data will be assessed on vaccination day and     during the 7 days following vaccination using either identical web-based or paper diaries,     depending on study participant preference.      Maternal serum samples will be collected for antibody titers relevant to the Tdap and     Influenza at time points that include: prior to vaccination(s), ~21 days post vaccination(s),     and at delivery. Additionally, cord blood serum will be analyzed for the same antibody     titers.      Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained     from medical record review.   "
38389|NCT02783157|"     In this study, the investigators aim to determine whether non-invasive autonomic modulation     decreases inflammation and complications after thoracic surgery. The investigators will test     the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major     thoracic surgery reduces inflammation and complications, particularly postoperative atrial     fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients     undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via     either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to     receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients     will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome     in this study will be time to occurrence of in-hospital POAF, which will be compared between     groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital     length of stay, postoperative morbidity, postoperative mortality, and serologic markers of     inflammation.   "
38390|NCT02783144|"     Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block     Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.   "
38391|NCT02783131|"     It is well known that medical errors account for a large amount of patient harm within the     hospital setting. This is a significant problem within the emergency context. A system that     acts as a prompt, guide and scribe for the obstetric emergency has been developed called     'Mednav'. Mednav is a navigation device for the management of medical emergencies; developed     at Chelsea and Westminster Hospital since 2010. This is a device which acts similar to a     satellite navigation devices in the automobile industry navigating you from A to B, MedNav     navigates the clinician from the unwell patient to the well patient.   "
38392|NCT02783118|"     Depression is one of the major challenges worldwide, with significant increasing personal,     economic, and societal costs. Although empirically supported treatments have been developed,     they are not always available for patients in routine clinical care. Even when patients are     adequately treated, they do not always respond to treatment and/or face a significant risk     for recurrence. Therefore, effective and wide accessible strategies to prevent the onset of     the very first depressive symptoms are necessary. Mental health apps could prove a valuable     alternative for that. Although preliminary research has indicated that apps could be useful     in treating depression, no study has attempted to test their utility in preventing depression     symptoms. The current study aims to contrast the efficacy of a smartphone app in preventing     depression compared against a waiting list condition. The app includes self-help materials     and exercises based on cognitive behavioral therapy (CBT) for depression, presented in a     tailored manner and incorporating gamification elements aimed at boosting the motivation to     use the app.      This study protocol is the first that capitalizes on the ubiquity of smartphones to     large-scale dissemination of CBT-based strategies aimed at preventing depression in     nonclinical populations. The objective of this study is to test an app designed to decrease     general cognitive vulnerability and promote engagement in protective, adaptive activities,     while counteracting the tendency of premature dropout (through gamification and     customization).   "
38393|NCT02783105|"     Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury     and concerns up to 30% of severely brain-injured patients.      PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges     causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more     pain, more cardiovascular distress, more infections and prolonged rehabilitation and     mechanical ventilation; additionally it could lead to a worse outcome.      Classical music was shown to reduce autonomic nervous system imbalance in healthy people and     in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured     patients presenting with PSH, as well.      Our study aims at demonstrating that early musical intervention, started with the weaning of     sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic     hyperactivity in traumatic brain-injured patients.   "
38394|NCT02783092|"     The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol     administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive     patients; that is, participants with at least 50% decrease in the frequency of epileptic     seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).      Primary end point(s): Rate of responsive patients; that is, participants with at least 50%     decrease in the frequency of epileptic seizures in the last month of the trial relative to     baseline (pretreatment with AEDs only).   "
38395|NCT02783079|"     This study looks at two different interventions used for the treatment of insomnia in     survivors of breast, colon, lung, prostate and gynecologic cancer.   "
38396|NCT02783066|"     Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes.     While most of these ulcers can be treated successfully, some will persist and become     infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic     ulcers will require amputation of the affected limb, resulting in staggering costs for both     the patient and the healthcare system. Prevention by identifying people at higher risk is key     for better clinical management of such patients. It is not uncommon for patients suffering     from diabetes to have concomitant lower extremity edema or venous insufficiency and they     subsequently may benefit from graduated compression. However, because of the common     association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians     are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and     possibility of gangrene.      A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot     Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The     device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and     offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back     to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The     offloading boot design holds the foot and lower leg in a position that reduces shear and     friction forces and provides a reduction in plantar pressure.      The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This     data will be downloaded at each clinic visit. The boot cannot pump blood around the     participant's foot unless fitted correctly and the battery is charged up overnight.      The purpose of this study is to conduct an interventional study study with N=15 diabetic     subjects with active foot ulcers to assess whether PulseFlow foot compression device can help     improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of     gait.      The key goals of the proposed project are to test whether a specially designed compression     device can improve lower extremity perfusion, whilst also simultaneously improving the     balance and walking performance. Investigators envision the use of this specially designed     offloading device with compression capability will help reduce the incidence of diabetic foot     ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device     might enhance daily physical activity as well as walking performance. Investigators will     conduct a prospective clinical study to validate these hypotheses. Potential changes in     walking and spontaneous daily physical activities will be assessed using validated     technologies that include walking analyzer system, balance assessment using body worn     sensors, and computerized pressure insoles.   "
38397|NCT02783053|"     Metformin is known to increase 18F-FDG uptake in subjects using metformin in retrospective     trials.      In this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on     temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean     (BMI < 24kg/m2) or obese subjects (BMI>28kg/m2). The investigators will measure 18F-FDG     uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure     before after using metformin.   "
38398|NCT02783040|"     To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of     midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)     and digoxin (P-gp probe drug)   "
38399|NCT02783027|"     The overarching goal of this proposal is to address the MedEvac foundation priority of     educational techniques and technologies and improve Helicopter Emergency Medical Services     (HEMS) safety by determining if overall sleep quality and intra-shift fatigue of HEMS     clinicians can be improved with real-time assessment and intervention.      Aim 1: To determine the short-term impact of an enhanced SleepTrackTXT intervention on HEMS     clinician fatigue reported in real-time during and at the end of shift work.      Aim 2: To determine the long-term impact of the SleepTrackTXT intervention on sleep quality     and sleep health indicators including hours of sleep and recovery between shift work.   "
38400|NCT02783014|"     This study investigates the central mechanisms of Overactive Bladder (OAB) in Patients with     Parkinson's Disease (PD).      The plan is to enroll 10 adults with Parkinson's disease and Overactive bladder (PD + OAB)     and 10 adults with Parkinson's disease only (PD). Both groups will undergo fMRI (functional     MRI).   "
38405|NCT02782936|"     Background: The gas mask is used to protect military and non-military subjects exposed to     respiratory hazards (CBRN agents). The aim of the study was to evaluate the impact of the gas     mask on respiratory patterns and indexes of the respiratory effort. Methods: We are     completing our study with 14 healthy subjects to evaluate breathing patterns, index of     respiratory efforts and blood gases. Seven conditions have been tested in a randomized order:     at rest, during effort (on a tread mill, standardized at 7 METs for all subjects) and during     induced hypoxemia with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway     pressure, inspiratory and expiratory flows were measured. An esophageal catheter was     introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate     indexes of respiratory effort (PTPeso, WOB). SpO2 was continuously measured and capillary     blood bases were drawn at the end of each condition. Each condition lasted 10 minutes, data     of the last 2 minutes at a steady state were considered for analyses. Results: The     preliminary analyses based on 10 subjects are presented here. Comparing the wearing of the     gas mask and without, most of the respiratory index increased in the tested conditions (at     rest, during induced hypoxemia and during effort). At rest, in 8 out of 10 healthy subject     the indexes of effort were higher with the gas mask, a statistical trend was observed with     the WOB (0.22±0.13 vs. 0.28±0.10 J/cycle; p = 0.059), the PTPes (101±35 vs. 122±47 cmH2O*s;     p=0.21) and SwingPeso (4.4±2.0 vs. 5.3±2.0 cmH2O; p=0.13). During the effort, the respiratory     index increased (WOB 4.0±2.6 vs. 5.6±3.2; p=0.10; PTPeso 406±211 vs. 606±65; p=0.04;     SwingPeso 14.8±8.1 vs. 21.8±9.0; p=0.13). There was no difference for the breathing pattern     and arterial blood gases data with and without mask. Data for induced hypoxemia are under     analysis. We measured on bench the inspiratory and expiratory resistances of the tested gas     mask (C4: inspiratory resistances = 3.2 cmH2O at 1 L/sec; expiratory resistances = 0.9 cmH2O     at 1 L/sec). This may explain in part the increased work of breathing with masks.     Conclusions: This study demonstrated an increase of the indexes of respiratory effort during     an exercise with the gas mask. This study is the first to directly assess the indexes of     efforts with esophageal pressure in this situation. Our results and method may be used as a     reference for evaluating tolerance with different designs of gas masks.   "
38406|NCT02782923|"     This is a single-center, prospective controlled simulation study designed comparing and     evaluating the driving performance of subjects who have had cervical spine surgery and the     use of a validated driving simulator. To date, there haven't been evidence-based     recommendations to determine a patient's fitness to drive in the peri-operative or     postoperative state. The objective of this study is to delineate the effect cervical spine     procedures have on driving performance in the peri-operative time period. The study will take     place at New York University Langone Medical Center - Hospital for Joint Diseases which will     include the surgeries. The follow up visits will be at the NYU Center for Musculoskeletal     Care.   "
38407|NCT02782910|"     Bipolar disorders are severe chronic disorders, marked by recurrent episodes of depression     and (hypo)mania. The disorder usually emerges in early adulthood and tends to have a highly     unpredictable course. Prevention of these episodes is essential, as they are associated with     marked impairment in social and occupational functioning. The investigators propose to     conduct a randomized, multi-center, observer-blind, parallel group controlled trial with an     78 week (18 month) intervention phase to test the hypothesis that continuous ambulatory     real-time monitoring of early warning signs for new depressive or (hypo)manic episodes by     smartphone based, innovative technology (e.g. GPS, acceleration sensor), including individual     threshold- based early intervention for these early warning signs, will prolong time to a new     mood episode and reduce hospitalizations (intervention group). In the control group     ambulatory monitoring of early warning signs for emerging depressive or (hypo)manic episodes     will occur in an identical manner, but the results will not be transmitted to the treating     psychiatrist. All patients in this trial, irrespective of their group assignment, will     receive guideline-based, state-of-the-art maintenance treatment.   "
38408|NCT02782897|"     This pilot study aims to investigate whether intravenous immunoglobulin is safe and effective     in alleviating perihematomal edema and neurologic deficits in patients with intracranial     hemorrhage.   "
38409|NCT02782884|"     Patients undergoing approximately 10 common outpatient general surgical operations will be     given a narcotic prescription for a specified number of pills.      Inpatients who are about to be discharged after surgery or trauma will be given narcotic     prescriptions for a specified number of pills. Patients will be given a patient report form     which they will use to record the number of pills they take each day and their daily pain     score on a scale of 0-10.   "
38454|NCT02782273|"     The study is prospective, double blinded, randomised controlled and has the purpose to     compare the analgesic effects of ketorolac or morphine intravenous in renal colic.   "
38413|NCT02782832|"     This study analyse the need for neuromuscular blockade in consecutive routine laparoscopic     procedures without standard use of neuromuscular blockade in an ambulatory laparoscopic     surgery setting and analyse specific reasons for using neuromuscular blockade in individual     patients. Furthermore, the study report the analgesic use in postoperative care unit and the     discharge rate.   "
38414|NCT02782819|"     Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution     is the current recommended initial fluid resuscitation. However, this kind of fluid has high     volume of distribution and may require large volume administration before achieve therapeutic     goal of shock reversal. There are rising concern about the delay in shock reversal and     adverse consequences of large amount volume of fluid therapy. Colloid fluid have been used as     the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and     promote shock reversal. Whether colloid infusion can improve shock reversal rate and decrease     complication associated with fluid resuscitation, had inconclusive information.   "
38415|NCT02782793|"     A prospective outcomes study in patients referred for endoscopic mucosal resection of complex     colon polyps.   "
38431|NCT02782572|"     This project deals with exercise in acute heart failure in three different groups     (conventional medical treatment; exercise with non-invasive ventilation and exercise with     placebo of non-invasive ventilation).   "
38432|NCT02782559|"     Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant     management for the treatment of preterm preeclampsia   "
38419|NCT02782741|"     Primary Objective:      To determine the effect of neoGAA (GZ402666) treatment on respiratory muscle strength     measured by percent predicted forced vital capacity (% FVC) in the upright position, as     compared to alglucosidase alfa.      Secondary Objective:      To determine the safety and effect of neoGAA treatment on functional endurance (6-minute walk     test (6MWT), inspiratory muscle strength (maximum inspiratory pressure (MIP)), expiratory     muscle strength (maximum expiratory pressure (MEP)), lower extremity muscle strength     (hand-held dynamometry (HHD)), motor function (Quick Motor Function Test (QMFT)), and     health-related quality of life (SF-12).   "
38420|NCT02782728|"     This pilot study will evaluate a computer-based intervention titled Trauma-informed     Personalized Scripts (TIPS). The goal of this intervention is to improve patient-provider     communication about sensitive topics such as intimate partner violence (IPV) and reproductive     coercion (RC). The main aim of this study is to pilot test TIPS in family planning clinics     using a randomized study design to compare the basic version of TIPS (a computer-based     assessment with provider scripts only) to an enhanced TIPS containing a tailored brief     intervention for patients along with provider scripts. The investigators plan to recruit 240     female patients ages 16-29 for this study.   "
38421|NCT02782715|"     The specific aims of this study are:        1. To determine the safety and feasibility of treating patients with a combination of MRI          guided stereotactic body radiation therapy and microwave ablation.        2. To assess short and long-term toxicity rates of patients treated with a combined          modality approach.        3. To assess local control, survival, and pathologic response to treatment   "
38422|NCT02782702|"     Hailey Hailey and Darier disease are rare genetic dermatoses. Mutations of 2 genes (ATP2C1 or     ATP2A2 respectively) are responsible for the diseases. These genes have a key role in calcium     pump; their defect create abnormal link between keratinocytes' desmosomes and induce skin     lesions. Clinically, patients present with inflammatory lesions located in the folds. Quality     of life is impaired because of pain, pruritus and tendency to infections. Lesions are     permanent but acute exacerbations occur in hot seasons because of increased sweating. Usual     therapies are often not effective (local treatment, laser, phototherapy). Because sweating is     a well established inducing or aggravating factor, botulism toxin could be an effective     treatment for these diseases.      Botulism toxin is already used in clinical practice and acts via a decreased sweet secretion.     Improvement of skin lesions in Hailey-Hailey or Darier diseases has been previously reported     in a few cases but there is no study properly evaluating the benefit of such treatment.      The aim of the project is to study the improvement of quality of life for patients suffering     from Hailey-Hailey or Darier diseases after a injections of botulism toxin in large skin     folds. The principal objective is to estimate the distribution of the variation of quality of     life at M1 vs. baseline.   "
38423|NCT02782689|"     The primary objective of this study is to demonstrate the non-inferiority of the 2-layer     compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the     treatment of venous leg ulcers in terms of complete healing at 16 weeks.   "
38424|NCT02782663|"     This is a open-label extension (OLE) study designed to evaluate the long-term efficacy,     safety, and tolerability of ABT-494.   "
38425|NCT02782650|"     This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm     birth including current and preferred counseling, barriers and facilitators for preferred     counseling from both obstetricians and neonatologists, as well as parents' views on this.      Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with     parental consent) but as some international guidelines, the Dutch guideline lacks detailed     recommendations on organization, content and preferred decision-making of the counseling.   "
38426|NCT02782637|"     This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm     birth including current and preferred counseling, barriers and facilitators for preferred     counseling from both obstetricians and neonatologists, as well as parents' views on this.      Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with     parental consent) but as some international guidelines, the Dutch guideline lacks detailed     recommendations on organization, content and preferred decision-making of the counselling.   "
38427|NCT02782624|"     To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once     daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered     orally   "
38455|NCT02782260|"     Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active     cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular     administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted     at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy     of the intervention.   "
38428|NCT02782611|"     Over the past several decades, a new science of subjective well-being has produced insights     into the factors that make people happy—from cultivating strong relationships to pursuing the     right goals. Drawing on these empirical findings, the investigators created a comprehensive     12-week intervention program, ENHANCE: Enduring Happiness and Continued Self-Enhancement. The     investigators multimodal program is designed to teach people essential skills in order to     produce sustainable changes in behavior and, as a result, long-lasting increases in     happiness. To test the effectiveness of ENHANCE, the investigators designed a six-month     randomized clinical trial. Participants will be assigned to an active treatment group or a     waiting group control. They will complete baseline assessments, and follow-up assessment at     three and six months after the start of the intervention. These assessments will contain     measures of subjective well-being and objective measures of health, as well as a variety of     psychological mediators (e.g., psychological needs) and moderators (e.g. personality). The     investigators will thus be able to explore not only whether ENHANCE works to improve     well-being, but also why and how ENHANCE works.   "
38429|NCT02782598|"     The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to     improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy     (CRT) patients.   "
38430|NCT02782585|"     Manual therapy (MT) techniques applied over cervical region have over both local (neck) and     distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological     mechanisms are hypothesized to explain the underlying effects, with effects originating from     peripheral mechanisms, spinal cord and supraspinal mechanisms.      There is also an increasing interest in the study of the role of psychological variables in     the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or     kinesiophobia are related to poor prognosis in the development of pain outcomes and     disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models     in this field.   "
38433|NCT02782546|"     This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia     free survival to 30% from <10% expected with the use of reduced intensity haplo-HCT in this     extremely high-risk patient cohort (based on the institutional experience using     non-myeloablative / reduced intensity conditioning in a similar patient cohort).      A formal safety evaluation will be done after every 6th patient enrolled and the trial will     be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (>60% any     grades or >30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).   "
38434|NCT02782533|"     Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity     treatment.   "
38435|NCT02782520|"     This study is a phase III, randomized, controled, parallel groups, single blinded, clinical     trial that aims at comparing the improvement of right ventricular function after     administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.      Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under     cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.      Patients needing fluid expansion in the first three hours after surgery will be randomized in     two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline     solution (3 mL/kg).      Right ventricular function measured with Swan Ganz catheter, 30 minutes and one hour after     fluid expansion will be the primary outcome.   "
38436|NCT02782507|"     The study is a pilot study of Cognitive therapy for people with psychosis who have     distressing visual hallucinations. The aim is to evaluate whether this is an acceptable,     feasible and effective treatment. This is a pilot study and there is no randomisation to     either CBT or treatment as usual (TAU). If a participant is allocated to the cognitive     therapy plus TAU condition then the participant will meet with a therapist on initially a     weekly basis and receive up to 8 sessions of CBT over a 2 month period. The participant will     also have regular assessments conducted by a researcher who is independent to the treatment     group. It is predicted that those people receiving CBT will improve on measures of symptoms,     and particularly for measures of visual hallucinations.   "
38437|NCT02782494|"     In patients receiving long term dialysis, using new generation of QuantiFERON-TB Gold Plus     can have less result variability in inter-experiment and serial follow up in comparing with     QuantiFERON-TB Gold In-tube.   "
38438|NCT02782481|"     This is a multicenter, randomized, double blind, placebo controlled parallel group clinical     study. Following a screening period of up to 28 days, eligible subjects will be randomized to     receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous     subcutaneous infusion of ND0612 or matching placebo for 16 weeks.   "
38439|NCT02782468|"     The purpose of this study is to evaluate the safety and tolerability of pevonedistat     administered as a single agent and in combination with azacitidine in adult east Asian     participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).   "
38440|NCT02782455|"     Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When     inflamed they become pathological and may present with protrusion and bleeding. A randomized,     triple blind , controlled study will be conducted to compare the efficacy of calcium     dobesilate against flavanoids in the management of early haemorrhoidal disease.   "
38441|NCT02782442|"     The purpose of this study is to use remote methods and scalable interactive neurotechnology     to generate important data on the potential for remote targeted cognitive treatment in people     with schizophrenia. The investigators will perform a double-blind randomized control trial in     120 participants with schizophrenia, comparing: 1) An evidence-based structured program of 40     hours of on-line auditory and social cognitive training (exercises over 12 weeks (-3.5 hours     per week), delivered with an innovative digital application which provides users with a     motivation coach to set personalized goals and with secure social networking for peer     support, Personalized Real-time Intervention for Motivational Enhancement (PRIME) ; vs.2) A     control condition of free-choice on-line cognitive exercises, encouraged at 3.5 hours per     week over 12 weeks, delivered with a standard commercial goal-setting app, Daily Goals.   "
38442|NCT02782429|"     The purpose of this study is to analyze the Ketamine with its anti-inflammatory profile would     be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since     these disorders contribute to an impact on morbidity / mortality in this population.   "
38443|NCT02782416|"     Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the     incidence of active TB   "
38444|NCT02782403|"     Objectives:      Primary:      Chronic Phase Cohort: To assess the rate of major cytogenetic response (MCyR) of an     alternating schedule of axitinib and bosutinib in patients with chronic myeloid leukemia,     chronic phase (CML-CP) after failure of/intolerance to >/= 3 tyrosine kinase inhibitors     (TKIs) using standard response criteria.      Advanced Phase Cohort - Phase I Portion: To determine the recommended phase II doses (RPTDs)     of axitinib and bosutinib in combination in patients with CML in accelerated phase (CML-AP)     or blast phase (CML-BP). (AP patients must have received >1 prior TKI).      Advanced Phase Cohort - Phase II Portion: To evaluate the rate of major hematologic response     (MaHR) of combined treatment with axitinib and bosutinib in patients with CML-AP or CML-BP     using standard response criteria. (AP patients must have received >1 prior TKI).   "
38457|NCT02782234|"     Contract management is a new management mode.      To help patients achieve fluid balance through contract management, that is:        1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;        2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value          prescribed by the doctors；        3. Fluid intake and output keep in balance;        4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.   "
38458|NCT02782221|"     Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing     effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism,     and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore     hypothesize that the fat metabolizing effects of GH depend on abrogation of insulin-dependent     signaling pathways.      In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive adipose     tissue biopsies taken after GH exposure and GH blocking, respectively.      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in     long-sight have great importance for the understanding of growth disorders from overweight     and type 2 diabetes to malnutrition and eating disorders.   "
38445|NCT02782390|"     Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the     same tooth. Dental practitioners have shown difficulties related to material's maintenance in     such type of cavities and therefore, several treatment options have been used. However, most     of them have shown a great failure percentage. A randomized clinical trial will be developed     with the objective of assessing the Hall technique in comparison with the composite resin     incremental technique in 464 primary molars' atypical carious lesions of children between 4     and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis     by means of visual assessment and intraoral examination. Selected teeth will be randomly     allocated into two groups. Teeth in the first group will be submitted to prefabricated     stainless steel crowns treatment (Hall technique); and the other, to composite resin     incremental technique, which will be always placed under rubber dam isolation. Lesions'     clinical and radiographic follow-up will be conducted after 6 and 12 months.      Treatment's efficacy will be assessed by means of four main outcomes:        1. Longevity, marginal adaptation, possible modification in patients' vertical dimension,          and caries lesion progression;        2. Patient-focused criteria (satisfaction, discomfort and quality of life impact);        3. cost-efficacy; and        4. Treatment-related parents', children' and operators' perception.      Other variables could be further analysed as secondary outcomes, such as techniques     performing time among operators, impact of the socio-economic characteristics on     restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons     between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank     test. Cox Regression will be used to enable the assessment of other variables' influence in     the results. Significance value of 5% will be adopted for all analysis.   "
38446|NCT02782377|"     Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been     studied in our department over the last 6 years. Sound waves pass into a balloon placed in     the anal canal and are used to measure the cross-sectional area. By gradually increasing and     decreasing the pressure in the balloon the investigators can measure the pressure at which     the cross-sectional area starts to increase and decrease, and the anal canal starts to open     and close. This assessment mimics the natural opening and closing of the anal canal and the     effect of squeezing the muscles.      The gold standard investigation of the anal sphincter muscles has been manometry which     measures anal canal pressure at rest and during squeeze. However, it has limitations. In     previous studies AAR has shown promise in the assessment of faecal incontinence and, that     unlike manometry, it has been able to distinguish between different types of incontinence.      The Recto-anal Inhibitory Reflex (RAIR) is a normal response when the rectum fills with     faeces, fluid or air, whereby there is a change in the pressures within the anal canal to     determine the type of contents. This can be absent or altered in patients who have difficulty     in opening their bowels. The RAIR is currently measured by anal manometry using a 4.9mm     catheter, resulting in an anal canal which is already partially opened prior to the     measurement, and potentially distorted.      AAR is considered a catheter free technique as the balloon has a cross-sectional area of only     0.4mm2 when collapsed. The investigators propose to measure the RAIR using a 1.7mm diameter     catheter alongside the AAR balloon to determine the effect that its placement has on the     recorded parameters of AAR. This aims to improve our understanding of the opening and closing     of the anal canal in response to distension of the rectum.   "
38447|NCT02782364|"     Anal Acoustic Reflectometry (AAR) is a technique that has been studied in our department over     the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to     measure the cross-sectional area. By gradually increasing and decreasing the pressure in the     balloon the investigators can measure the pressure at which the cross-sectional area starts     to increase and decrease, and the anal canal starts to open and close. This assessment mimics     the natural opening and closing of the anal canal and the effect of squeezing the muscles.      The gold standard investigation of the anal sphincter muscles has been manometry which     measures anal canal pressure at rest and during squeeze. However, it has limitations. Despite     the two measurements being within the normal range, some patients can have significant faecal     incontinence. This has prompted clinicians to search for a better investigation to guide the     management of this condition.      AAR is a reproducible and repeatable technique that has been used as a research technique in     the assessment of faecal incontinence. It has been shown to correlate with symptom severity     and, unlike manometry, is able to distinguish between different symptomatic subgroups with     faceal incontinence. In our studies so far the investigators have increased the bag inflation     pressure a step at a time which means that each study takes about 20 minutes to perform. The     limitation of this method is that during the measurement of squeeze pressure the sphincter     muscle is subject to fatigue. A recent study using the acoustic technique in the urethra has     demonstrated a faster method of recording measurements over an 8 minute period. The     investigators propose to study the fatiguability effects of this faster technique and     validate the method against the existing step-wise technique and standard anal manometry.      Patients will be randomised into two groups:        1. Stepwise then fast-fill        2. Fast-fill then stepwise   "
38448|NCT02782351|"     The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T     cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a     humanized scFv. All participants will receive autologous chimeric antigen receptor engineered     T cells.   "
38449|NCT02782338|"     A prospective study intended to examine the effect of topical Voltaren-Ophtha 0.1% eye drops     after cataract surgery on INR levels (international normalized ratio) in patients taking     warfarin.   "
38450|NCT02782325|"     Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial     dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of     the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in     which 50% of the patients will receive FMT and 50% will receive a placebo FMT. Additionally     the trial offers an open label extension period.   "
38451|NCT02782312|"     The objective of this study is to assess the efficacy and safety of Salmeterol-Fluticasone     （ICS and LABA）combined inhaled therapy for non-cystic fibrosis（non-CF）bronchiectasis patients     with chronic airflow obstruction. Moreover, subgroup analysis is performed to explore which     populations of bronchiectasis patients this treatment is suitable for.   "
38456|NCT02782247|"     Chronic viral hepatitis often leads to liver scarring - cirrhosis. If the virus is eradicated     from the liver, the liver scarring and liver function often recovers. In some patients the     damage is too severe and recovery does not take place. It is not yet known which patients     have liver disease that is too advanced to benefit from therapy nor is it known how fast the     recovery occurs.      Non-intrusive dynamic liver testing (DLT) may allow us to predict the functionality of the     liver post treatment and may guide us in treatment choices - for example patients who are     predicted not to recover may be prioritised for transplantation. Indocyanine green (ICG) is a     dye solely excreted by the liver into bile and used to measure its dynamic function.     Transient elastography is similar to ultrasound and measures the degree of fibrosis within     the liver.      The investigators hypothesise that the use of non-intrusive dynamic liver testing     pre-treatment, will allow us to delineate patients before therapy who will have functional     liver recovery following viral eradication.      The investigators hypothesise that monitoring changes in liver fibrosis and liver function in     patients with historical viral clearance will allow an assessment of the likely speed of     recovery of liver fibrosis and function - for example if all patients 5 years after treatment     for viral hepatitis induced cirrhosis have 'normal' fibrosis and liver function scores the     investigators will be able to conclude that recovery is complete within 5 years.      The investigators will perform a study pre and post-treatment assessing liver function using     non-intrusive dynamic liver testing in addition to currently-used 'liver function' scoring     systems, in a multivariate analysis, to determine whether or not the investigators can     identify patients who are will have functional liver recovery post therapy.   "
38459|NCT02782208|"     Growth hormone (GH) is essential for longitudinal bone growth and somatic development. These     protein anabolic effects require sufficient nutritional supply. During fasting and caloric     restriction GH predominantly promotes fat metabolism.      GH counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose     uptake in skeletal muscle has been most extensively studied. Substrate competition between     elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can be     tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses the     fat metabolizing effects of GH.      The hypothesis is, that the suppressive effect of GH on insulin-stimulated glucose uptake in     skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism.      In order to investigate this, eight adult hypopituitary patients with documented     GH-deficiency will be studied in the presence and absence of GH and acipimox, respectively,     and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed.      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in     long-sight have great importance for the understanding of growth disorders from overweight     and type 2 diabetes to malnutrition and eating disorders.   "
38460|NCT02782195|"     Eight adolescent and young adult subjects with type 1 diabetes, age 16−24 years, will be     recruited for this study on the basis of informed consent. Participants will be invited to     attend the Wellcome Trust Clinical Research Facility at Addenbrooke's Hospital, Cambridge, on     two occasions. On each occasion participants will arrive at the unit at 9am having controlled     their diabetes with short acting insulin for 24 hours and they will remain in the unit until     8am the next morning. During the day, between 9am and 6pm participants will remain fasting     and their blood glucose levels will be controlled by intravenous insulin, the dose being     determined by 15−30 minute blood glucose estimations. At 1800hr on visit 1 the subjects will     be asked to ingest an evening meal enriched by a cold isotope glucose tracer (non     radioactive). The variable insulin infusion will be adjusted to allow for the meal in order     to achieve good glycaemic control after the meal until 0200hr. From then until 0800hr in the     morning the study team will again adjust the infusion rates to maintain normal glycemia until     the participants are ready to go home on their normal insulin regimen. On the second visit     the protocol will be identical until 1800hr when instead of giving the meal variable amounts     of glucose will be infused to ensure the glucose levels are identical to those observed on     visit 1. After 0200hr the study will be effectively finished but the study team will continue     to vary the insulin infusion to keep blood glucose levels normal until the subjects can go     home on their normal insulin regime at 8am.      In order to achieve sufficient information to make all the calculations needed other cold     isotope glucose tracers will be infused during the study period. These safe non radioactive     isotope tracers will enable us to assess glucose being produced by the body, its distribution     and utilization. Throughout both study periods the subjects will be monitored very closely by     a Clinical Research Fellow, assisted by a Research Nurse, in order to avoid any risk of low     blood glucose levels.   "
38461|NCT02782182|"     The purpose of this study is to see whether it is possible to give 8 doses of a combination     of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be     removed with surgery.   "
38462|NCT02782169|"     Medical abortion has been associated with significant pain. The objective of this trial is to     determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to     the standard of care analgesics, will decrease experienced pain. Investigators will perform a     randomized, double-blinded, placebo-controlled trial. Participant pain levels and side     effects will be assessed at multiple time points, along with a measure of satisfaction.   "
38463|NCT02782156|"     In ear, nose, throat (ENT) and jaw surgery departments, up to 60% of patients suffer from     alcohol dependence (Allen et al., 2009), and may develop an alcohol withdrawal syndrome (AWS)     when undergoing sur-gery. Caring for these patients creates a major challenge for all persons     involved: Health care staff is not only challenged by the primary illness but also by     increased risk of life-threatening complications (infection, bleeding, cardiopulmonary     dysfunction, impaired wound healing, re-operation), higher mortality rate, and longer     duration of hospitalization due to preoperative alcohol use and the development of an AWS     (Delgado-Rodriguez, Gomez-Ortega, Mariscal-Ortiz, Palma-Perez, & Sillero-Arenas, 2003; Eyer     et al., 2011; Foy, Kay, & Taylor, 1997; Genther & Gourin, 2012; Kuo et al., 2008; Mayo-Smith     et al., 2004; McCusker, Cole, Abrahamowicz, Primeau, & Belzile, 2002; Neyman, Gourin, &     Terris, 2005; O'Brien et al., 2007). Moreover, nearly five percent of all patients with an     AWS develop an alcohol withdrawal delirium (AWD) which, without any therapy, will end     lethally in 15% of all cases. With adequate medical and other interventions lethality is     about two percent (Diener, 2003; Wright, Myrick, Henderson, Peters, & Malcolm, 2006).     Additionally, the occurrence of an AWS and / or AWD represents a threatening, time-intensive     and complex situation for family members (Repper-DeLisi et al., 2008; Yu et al., 2012).      Since 2011, in addition to patients undergoing short-term surgery, also patients with     oncological diagnoses are hospitalized in the ENT and Jaw Surgery Department at the     University Hospital Basel (USB). These patients are in need of prolonged surgical treatments     and resulting longer periods of abstinence from food and drink, including alcohol and other     substances, increase the risk of alcohol withdrawal. For instance, in the ENT and Jaw Surgery     Department, in 2011, 74 out of 910 inpatients were at risk for or already experienced an AWD     and 47 of them needed permanent supervision to guarantee their safety. Bridging the period of     abstinence by drinking alcohol pre- and postoperatively is a suboptimal option for these     patients due to the relatively long surgical treatment. This situation called for action:     based on positive experiences within the dementia-delirium-programme of USB (Hasemann &     Pretto, 2006), an evidence-based approach to screen for, detect and treat AWS and / or AWD in     ENT and jaw surgery patients was developed and implemented (Hasemann, 2013). Now, this new     approach needs to be evaluated.   "
38464|NCT02782143|"     The proposed Study validates the accuracy of the modified Confusion Assessment Method for the     Emergency Department   "
38465|NCT02782130|"     This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability,     impact, and long-term sustainability of the Epic Allies intervention application (app), a     theory-based mobile app that utilizes game mechanics and social networking features to     improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral     suppression among HIV-positive young men who have sex with men (YMSM) and trans women who     have sex with men. Subjects will be randomized to either the intervention branch of the Epic     Allies app or the control branch of the app.   "
38466|NCT02782104|"     The purpose of this study is to assess the safety and tolerability of intranasal esketamine     in participants with treatment-resistant depression (TRD).   "
38505|NCT02781597|"     The purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding     in patients of hemoptysis and also to evaluate the safety of tranexamic acid.   "
38476|NCT02781974|"     The study is a parallel-group single blinded randomized controlled trial, examining the     effect of exercise on physical function in older women with osteoporosis and a history of     vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the     intervention group and the control group. The intervention will follow newly developed     exercise recommendations for people with osteoporosis and vertebral fractures, which states     the balance- and strength exercises should be performed at least twice a week. The     intervention is a group exercise session circuit program lasting for 12 weeks. The     participants will be tested at baseline, and followed up at 3 months and 6 months.   "
38515|NCT02781467|"     This study will find the highest acceptable treatment dose of cord blood, culture expanded     natural killer (NK) cells, a kind of immune cell, in patients with relapsed and/or refractory     acute myeloid leukemia.      The NK cells will be given with chemotherapy and Recombinant human interleukin 2 (rhIL-2) to     help the NK cells expand in the body. The safety of this treatment will be studied and     researchers want to learn if NK cells will help in treating the AML.   "
38467|NCT02782091|"     Schizophrenia (SZ) is a chronic, severe disease resulting in a misperception of reality,     major social withdrawal and cognitive disturbances. Executive dysfunctions are widely     considered as primary determinants of functional outcome. However, classic neuropsychological     executive function measures poorly represent patients' functional outcome and seem     inappropriate to evaluate the real-world functional impact of the disease.      In this perspective, Shallice and Burgess have developed for brain-damaged patients, the     Multiple Errands Test (MET) allowing to assess planning, adaptation, problem solving and     mental flexibility in real life settings, thus better capturing day-to-day abilities and     including contextual (social, perceptive) influences. Setting the assessment outside the     laboratory can help to identify subtle executive impairment not systematically expressed in     standard care conditions and consequently improve the future care solutions. MET is based on     the Supervisory Attentional System (SAS) model of executive functioning and attention control     that specifies how thought and action schema become activated or suppressed for routine and     non-routine circumstances .      MET has been designed to measure real-world executive performance confronting the     participants to unpredictable affordances and interpersonal interactions while planning and     problem solving. Patients are asked to accomplish several tasks of variable complexity in an     unknown commercial district. A number of rules must be respected and thus an action plan,     strategy formulation, time and space management with very little assistance of the examiner     are required.      Most of the studies involving MET were conceived for patients with acquired brain damage.     LeThiec offered an extensive protocol with the initial scoring system (in terms of     inefficiencies, rule breaks, interpretation failures and task execution failures). Simplified     versions of MET were also suggested to be more suitable in hospital settings. Only one study     was done in SZ including a single patient, it is therefore difficult to draw conclusions     about clinical utility in SZ. To date, no other studies investigated the suitability of MET     in patients with psychosis, while executive impairment is well documented in this population     The investigators hypothesized that the Multiple Errands Test (MET), an ecological assessment     of executive function has a better ability to measure everyday adaptative functioning SZ,     compared to conventional EF assessment methods.      The objectives of this study are: (1) establish normative data and (2) study discriminant     validity of this tool with a large panel of EF measures.   "
38468|NCT02782078|"     Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA     guidelines) but some interaction is observed. The objective of this study is to evaluate and     quantify rifampicin interaction on clindamycin   "
38469|NCT02782065|"     The purpose of this research will be to evaluate the reliability and validity of the HASS     tool in a cohort of patients' ages 7 to18 years old against the gold standard of spirometry,     and in ages 2 to 6 against spirometry, if possible, and the most similar validated tool, the     PRAM.   "
38470|NCT02782052|"     Activity-related dyspnoea appears to be the earliest and the most frequent complaint for     which patients with PAH seek medical attention. This symptom progresses relentlessly with     time leading invariably to avoidance of activity with consequent skeletal muscle     deconditioning and an impoverished quality of life. Unfortunately, effective management of     this disabling symptom awaits a better understanding of its underlying physiology. Our team     has recently showed that PAH patients may exhibit reduced expiratory flows at low lung     volumes at spirometry (namely instantaneous forced expiratory flows measured after 50% and     75% of the FVC has been exhaled [FEF50% and FEF75%] lower than predicted), despite a     preserved forced expiratory volume in 1 second/forced vital capacity ratio (FEV1/FVC) .     Several studies have shown that such a finding (small airway disease) could be common in     certain PAH cohorts, have either related it to incidental descriptions of airway wall     thickening with lymphocytic infiltration in PAH or proposed several other speculative     explanatory mechanisms, either biological or mechanical. Whatever its cause, reduced     expiratory flows at low lung volumes imply that the operating tidal volume (VT) range becomes     closer than normally to residual volume (RV) mostly through an increase in RV (elevated     residual volume/total lung capacity ratio, RV/TLC). The reduced difference between forced and     tidal expiratory flows promotes dynamic lung hyperinflation [i.e., a progressive increase in     end-expiratory lung volume (EELV)] under conditions of increased ventilatory demand. Dynamic     lung hyperinflation (DH) is well known to have serious sensory consequences, i.e., increase     in dyspnoea intensity, as clearly shown in patients with chronic obstructive pulmonary     disease and chronic heart failure. The aim of this study is to evaluate whether     administration of inhaled BDs (β2-agonist and/or anticholinergic), as add-ons to     vasodilators, would be beneficial to PAH patients by reducing and/or delaying the rate of     onset of DH, thus ameliorating the exertional symptoms in patients with stable PAH undergoing     high-intensity constant work-rate (CWR) cycle endurance test.      This is a randomised double-blind placebo-controlled crossover study. Design: 5 visits; V1:     screening, familiarization, incremental cardiopulmonary exercise testing (CPET); V2: constant     work-rate (CWR-CPET); V3, V4 and V5: CWR-CPET after intervention, in a random order: Placebo     (P), Ipratropium Bromide (IB), Ipratropium Bromide + Salbutamol (IB+SALB).   "
38471|NCT02782039|"     The purpose of that register is to collect medical information about patients suffering of     APS with or without associated SLE.   "
38472|NCT02782026|"     In this prospective case-control study, the investigators will evaluate the diagnostic     performance of a novel electronic nose (E-nose) for the detection of Pulmonary Arterial     Hypertension (PAH). This study is designed to:        1. Assess the performance of the E-nose to discriminate controls from patients with PAH        2. Assess the performance of the E-nose to discriminate between different subtypes of          pulmonary hypertension (PH), namely idiopathic PAH, heritable PAH with BMPR2 mutation          and chronic thromboembolic PH        3. Assess the performance of the E-nose to discriminate controls from asymptomatic patients          with PH who carry BMPR2 mutations.   "
38473|NCT02782013|"     Pneumonia is a common infectious disease of the lung, often requiring treatment in the     hospital. Clinical scoring systems are available, identifying patients not requiring     hospitalization. However, the course of disease of patients in the hospital remains hard to     predict. While most patients will recover quickly, some will, despite appropriate treatment,     develop a severe course leading to sepsis and systemic responses resulting in organ     dysfunction. The PROGRESS study aims to identify clinical, genetic, and other molecular     markers and combinations thereof predicting a severe course of pneumonia in the hospital.     Such predictors will, for instance, support decisions on earlier transfer of patients to     intensive care and thus improving outcome.   "
38506|NCT02781584|"     The primary objective of this study is to evaluate the safety and tolerability of selonsertib     (SEL; formerly GS-4997), GS-0976, and GS-9674 in adults with nonalcoholic steatohepatitis     (NASH).   "
38474|NCT02782000|"     With the number of aged people increasing and the lifespan lengthen, dementia is becoming a     great public challenge in China. Early recognition of dementia is crucial to improve the     prognosis of dementia patients and decrease the society disease burden. It is a pity that the     early recognition rate of dementia is less than 7% in China. Most of the aged people live in     the community and general practitioners (GP) in community provide health service much more     frequently than other medical workers. It is suggested that GPs should be the best one to     screen dementia in its early period. However, most of GPs have not receive any training about     dementia early recognition in China. It is imperative and meaningful to provide training to     GPs for improve GPs' knowledge and skills about dementia early recognition. How to train GPs     for early recognizing dementia and how about the training effect? Which training model may be     better? We did not find consistent conclusion about these questions in China. This study aims     to set up an effective and convenient model to training GPs in dementia early recognition. A     total of 152 GPs in Beijing will be enrolled and be randomly divided into two groups. One     group will firstly have lessons about dementia early recognition and then receive     face-to-face supervision and key messages by Wechat about dementia early recognition once a     month in the following 6 months. Another group will firstly have lessons about dementia early     recognition and then receive face-to-face supervision and key messages by Wechat about     dementia early recognition once a month in the following 3 months. The score of knowledge and     attitude about dementia early recognition, the accuracy of analyzing dementia cases, the     usage of dementia screening scales and the referral rate of dementia will be evaluated at     different time point respectively. This study will provide evidence for training GPs     effectively in dementia early recognition in the future and will promote dementia early     recognition in community.   "
38475|NCT02781987|"     The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in     chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether     CP patients in early clinical stage have a higher PEP incidence, and to identify the     predictive and protective factors for PEP in chronic pancreatitis patients.   "
38477|NCT02781961|"     Previous studies have shown that histological changes in the gastric mucosa between obese and     non-obese individuals do exist. Understanding these histological differences (between obese     and non-obese individuals) might elucidate obesity pathophysiology.      However, the data is scarce and even contradictory. Even less is known about the histological     characteristics of the duodenal mucosa in obesity and lean states, but several studies     already performed hint for some differences. These differences might influence gut hormones     composition and function and play a crucial role in the development of obesity and metabolic     syndrome. To our best knowledge, in-vivo, human, real-time cellular level comparison of     gastric and duodenal mucosa has never been done. This can be now accomplished with pCLE.      pCLE, is composed from a miniature microscope assembled in the tip of an optical fiber. This     optic fiber is then inserted through the working channel of a standard endoscope, bringing     the microscope at the tip of the fiber to close proximity with the tissue. The system applies     a blue-light laser that after staining with fluorescein (IV 2.5 ml, 10% fluorescein, once)     provides a cellular-level, in-vivo, real time images: the concept of so called optical     biopsies. The system has been used as an auxiliary tool in GI-endoscopy in recent years.     This technology has been shown to be useful in identifying objective histological features     and even intramucosal bacteria in different tissues.   "
38478|NCT02781948|"     Evaluate the repeatability and reproducibility of iVue for measuring the total corneal     thickness, the epithelial thickness, and the stromal thickness in normal subjects and     patients with various corneal conditions.   "
38479|NCT02781935|"     The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination     with other imaging modalities (multiparametric MRI and CT Scan) in determining the true     status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for     unresectable or borderline resectable colorectal liver metastasis (CRLM).   "
38480|NCT02781922|"     The purpose of this study is to evaluate the efficacy and safety of intracoronary injection     of JRM-001 after reconstructive surgery in pediatric patients with functional single     ventricle   "
38481|NCT02781909|"     Novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the     duration of TB treatment) and to treat XDR-TB cases are urgently required. Host-Directed     therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS)     could be useful in this context, and therefore its the appropriateness and potential effect     of this approach needs to be evaluated in humans. Investigators do propose a prospective,     randomized, pilot study to estimate the potential efficacy and safety of using adjunctive     ibuprofen for the treatment of XDR tuberculosis.   "
38482|NCT02781896|"     The purpose of this study is to determine whether a left ventricular rapid pacing using the     valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the     overall procedure duration in comparison with the conventional method.   "
38483|NCT02781883|"     The primary objective of this study is to assess whether the combination of BP1001 and LDAC     provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete     hematologic recovery [CRi], Complete Remission with incomplete platelet recovery [CRp]) than     LDAC alone (by historical comparison) in participants with AML that cannot or elect not to be     treated with more intensive chemotherapy. Safety, pharmacokinetics, overall survival, time to     response, and duration of response will also be studied.   "
38484|NCT02781870|"     This study aims to visualize the implanted mesh in vivo by MRI in 20 patients at 1 month and     12 months post-operatively. Moreover, we want to evaluate the safety and efficiency of     non-penetration mesh fixation techniques using pre-designed ENDOLAP 3D visible mesh placement     versus mesh fixation using a synthetic LiquiBand Fix 8 glue for laparoscopic treatment of     groin hernias.      A total of 100 male and female patients will be entered in the trial in Maria Middelares     Ghent, for which an inclusion period of 24 months is anticipated. Four surgeons of the     department of surgery will screen all eligible consecutive patients for inclusion in the     study. They will inform all patients about the surgery and the follow-up with MRI scan     thereafter.   "
38485|NCT02781857|"     To answer the question whether a disease specific profile of breath in patients with lung     cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by     mass spectrometry.   "
38486|NCT02781844|"     This study is being conducted to characterize the effects of twice daily administration of     rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and     tolerability over the course of 24 hours as compared with the current once daily dosing     regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara®).   "
38487|NCT02781831|"     Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted     gait training system for stroke survivors. It is anticipated that robot-assisted gait     rehabilitation in combination with standard hospital based rehabilitation will achieve     significantly better gait outcomes than standard hospital based rehabilitation alone.   "
38488|NCT02781818|"     Purpose: To evaluate the effectiveness of intralesional triamcinolone for the treatment of     hidradenitis suppurativa      Participants: Patients diagnosed with Hidradenitis Suppurativa that have active inflammatory     HS lesions. Up to 60 lesions will be treated. Between 20 and 60 patients will be enrolled     dependent on the number of lesions they have treated. (up to 3 per patient)      Procedures (methods): Injection of triamcinolone or placebo into active lesions of     hidradenitis suppurativa   "
38489|NCT02781805|"     The goal of this study is to mechanistically define the potential anticancer activities of     the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn novel     information about the impact of BP on gamma delta (γδ) T cells in breast tissues as well as     epithelial breast cell differentiation of high-risk women. To this end, we have designed a BP     window trial to examine the effect of 1 - 3 weeks administration of alendronate on women at     high-risk for breast cancer, at the level of immunosurveillance and mammary epithelial cell     differentiation.   "
38511|NCT02781519|"     The purpose of the study is to characterize the acute effects of cannabinoids in women     relative to men and to begin probing the mechanisms that may underlie gender differences.   "
38512|NCT02781506|"     Nivolumab (brand name Opdivo): IV, 3 mg/kg q2 weeks, until disease progression or     unacceptable toxicity; SABR, dose variable, in 1-3 fractions.   "
38513|NCT02781493|"     Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing     quality before colonoscopy.   "
38490|NCT02781792|"     Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in     glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its     activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as     well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of     this drug and known oscillations in DNA damage repair make it an ideal candidate for     chronotherapy.      Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and     maximizing efficacy through delivery of a medication according to the timing of biological     rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side     effects and increase in anti-tumor activity for a variety of cancers, but has never been     applied to the treatment of gliomas.      Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial     glioma xenografts and the success of chronotherapy in the treatment of other cancers, the     invesitgators hypothesize that the timing of TMZ treatment will alter its efficacy and     toxicity.   "
38491|NCT02781779|"     The purpose of this study is to learn how effective each of the two dressings, Silverlon® and     AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure     wound infections.   "
38492|NCT02781766|"     Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to     maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds     and other serious bleeding events, prophylactic factor replacement therapy is used. Because     of the high cost and limited availability of clotting factor concentrates, dosing is a     crucial issue for prophylaxis therapy. Several studies reported a better correlation between     clinical bleeding tendency of patients with haemophilia and thrombin generation assay results     compared to FVIII/FIX levels. However there is no specific data showing that thrombin     generation may be a better indicator of the clinical efficacy of prophylaxis compared to the     conventional FVIII measurement.      The main objective of this open, multicentre, prospective study is to compare trough thrombin     generation capacity and FVIII levels in severe haemophilia patients and compare these two     laboratory results with:        -  the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in          the last 6 months        -  the number of additional FVIII units used in the last 6 months      This project requires no change in term of type of treatment : During the study, each patient     will be treated by his usual clotting factor at the usual regimen (frequency and dosage).      The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results   "
38493|NCT02781753|"     The purpose of this study is to evaluate the dosages of recombinant human serum     albumin/interferon alpha2b fusion protein injection in healthy subjects.   "
38494|NCT02781740|"     Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder. The     most effective treatment for OSA is continuous positive airway pressure (CPAP). CPAP therapy     has been shown to significantly reduce subjective sleepiness and blood pressure in patients     with symptomatic OSA. Its effectiveness tends to depend on its nightly usage and a commonly     held view is that CPAP should be used for at least 4h/night. However, previous studies have     estimated that a considerable proportion of CPAP users fail to achieve this. In addition,     there is inadequate evidence to support this apparent threshold effect and so it is unclear     whether such patients actually benefit from treatment or whether they could be withdrawn from     CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly     usage of CPAP.      The aim of the proposed project is to study the effect of CPAP withdrawal on subjective     sleepiness in OSA patients using CPAP for less than 4h/night on average. We hypothesize that     two-week CPAP withdrawal in patients with 3-4h/night use will lead to a return of OSA-related     symptoms. This trial will better establish the minimum level of CPAP adherence which could     generally be regarded as effective in reducing OSA-related symptoms.   "
38495|NCT02781727|"     A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth     hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be     given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females)     with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH :     Genotropin). This is a global trial that will be conducted in, but not limited to, the United     States, Canada, Germany, France, Poland, Bulgaria, Russia and Australia.   "
38507|NCT02781571|"     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir     (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV)     who have received a liver transplant.   "
38508|NCT02781558|"     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir     (SOF/VEL) fixed dose combination (FDC) and SOF/VEL FDC and Ribavirin (RBV) for 12 weeks in     participants with chronic genotype 3 HCV infection and compensated cirrhosis.   "
38496|NCT02781714|"     Meeting women's need for postpartum family planning is has been acknowledged as a global     priority in maternal and child health. The prevention of unintended pregnancies in     sub-Saharan African countries, which carry the highest global burdens of maternal mortality     and HIV infection, is projected to substantially decrease maternal and neonatal morbidity and     mortality. Many barriers to contraceptive uptake exist, both within and outside of the     postpartum time period, and include socio-cultural, economic, and supply-side factors.     Furthermore, while the importance of engaging men in family planning programs has been     acknowledged for decades, few interventions have succeeded in increasing male involvement in     family planning while maintaining a focus on women's empowerment. Innovative approaches to     meeting the family planning needs of women and couples are urgently needed.      Public health interventions are increasingly incorporating mobile health (mHealth) approaches     using short message service (SMS) technology in low-income countries, approaches that have     demonstrated benefit among various reproductive health outcomes. The investigators     hypothesize that personalized, bidirectional SMS dialogue with individual women and couples     will increase postpartum contraceptive uptake, thereby decreasing unmet need for family     planning in Kenya. The investigators have collaborated with the University of Washington (UW)     Department of Computer Science and Engineering (CSE) along with Kenyan telecommunication     providers to develop a hybrid messaging system that allows for innovative bidirectional SMS     messaging. This system has been used successfully in maternal child health (MCH) clinics in     Kenya. In qualitative research, women in Kenya have expressed a strong desire for mHealth     support to provide additional education, counseling and reminders to supplement counseling by     health workers.      The investigators propose a randomized controlled trial (RCT) comparing the effects of     bidirectional SMS dialogue vs. control on highly effective contraceptive use at 6 months     postpartum among HIV negative women and couples in Nyanza Province, Kenya. Data from this RCT     and accompanying qualitative study will contribute to innovative, scale-able strategies to     address unmet need for contraception and increase male involvement in family planning.   "
38497|NCT02781701|"     From Weill Cornell Medical College Center for Sleep Medicine, the investigators will recruit     patients (N = 25) with previously documented moderate to severe OSA. They will receive an     all-night in-home sleep study to document the severity of their OSA immediately before     starting the training regimen. Scales and questionnaires measuring sleepiness, snoring,     fatigue, and insomnia will be administered prior to starting the training and repeated after     six weeks of training. Subjects may be removed from the study due to failing to adhere to the     training regimen at anytime via remote data monitoring. The principal measure of the efficacy     of the treatment will be the change in RDI, the number of abnormal breathing events per hour     of sleep.   "
38498|NCT02781688|"     Pilot study to assess a multi-component intervention to increase physical activity in persons     with depression.   "
38499|NCT02781675|"     A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including nuts,     moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin olive     oil as the main source of fat has been associated with reduced risk of cardiovascular disease     (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines Advisory     Committee. The strongest experimental support for this recommendation derives from the     success of the recent PREDIMED CVD outcomes trial, and studies indicating that a     Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular disease     risk in comparison to either low-fat or Western dietary patterns. However, in none of these     studies were comparisons made between the effects of Mediterranean-style diets with     low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to     determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a     Mediterranean dietary pattern based on that used in the PREDIMED study results in similar     improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a     standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2)     modification of the Mediterranean diet by replacing low-fat dairy products with high-fat     dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase     LDL-C and apoB but may raise large buoyant LDL particles compared with a standard     Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result in     comparable reductions in levels of inflammatory markers and oxidized LDL, and improvements in     endothelial function compared to a Western diet.   "
38500|NCT02781662|"     This study evaluates an intervention to reduce medication errors and adverse drug events in     older adults who have recently been discharged from the hospital and prescribed     anticoagulants, diabetes agents, or opioids. Half of the study participants will receive the     intervention, while the other half will receive usual care.   "
38501|NCT02781649|"     In this study, individuals without hepatitis C infection who are on the kidney transplant     waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be     treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100     mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant     procedure and continued for 12 weeks post-renal transplant.   "
38502|NCT02781636|"     30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out     to 90 days.   "
38503|NCT02781623|"     This study will quantify and examine the extent to which the quadriceps femoris muscle group     atrophies following tibial plateau fractures and the length of time that atrophy affects     function. The study will also look at the effects of tibial plateau fractures on the     quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy     will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post     operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be     scanned in order for the non-injured leg to serve as the control. In this way muscle volume     can be estimated from the muscle thickness at specific locations in the thigh. The muscle     strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring     isokinetic knee-extension torque, and functional assessment questionnaires will be completed     at each study visit.   "
38504|NCT02781610|"     Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during     which symptoms of lung infection increase and lung function decreases. These pulmonary     exacerbations are treated with varying antibiotics for varying time periods based on needs     determined by individual patients, their families, and the health care providers. Cystic     fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the     Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also     identified key questions for which additional studies were needed.      A strong desire among clinicians to reduce treatment durations (and reduce cost,     inconvenience, and potential toxicities) is in conflict with belief that patients not     responding robustly to treatment might benefit from extending treatment.      This randomized, controlled, open-label study is designed to evaluate the efficacy and safety     of differing durations of IV treatment, given in the hospital or at home for a pulmonary     exacerbation in adult patients with CF.   "
38509|NCT02781545|"     Infants requiring surgery in the neonatal period for complex congenital heart diseases are at     risk for developmental problems. For infants with congenital heart diseases with admixture     physiology and single ventricles, optimal circulation is associated with signs of adequate     systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%.     Infants are often unable to withstand standardized developmental testing during early infancy     due to medical fragility and sternal precautions after surgery. Evaluation of the quality of     spontaneous movements and movement variability is a good alternative. The quality of general     movements in early infancy is a valid predictor of neurological disorders in high risk infant     groups and is assessed with short periods of video-recorded observations. This methodology     has yet to be studied in infants with complex congenital heart disease that require surgery     as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to     document developmental outcome.   "
38510|NCT02781532|"     The main objective of our study is to determine if the evaluation of ingesta of cancer     patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of     patients during hospitalization (for patients malnourished, at risk of malnutrition or risk     free).   "
38514|NCT02781480|"     A clinical trial of AAV2/5 vector for patients with Defects in RPE65   "
38516|NCT02781454|"     The purpose of this research study is to find out whether the drug mexiletine will be     effective in lowering motor neuron electrical activity in the brains and nerves in the arms     of people with ALS. The investigators will also determine if there are any signs that the     drug may slow down the progression of ALS and reduce muscle cramps and muscle twitching. This     will be determined through transcranial magnetic stimulation (TMS) and threshold tracking     nerve conduction studies (TTNCS). In this trial, the participants will be taking either     300mg/day of mexiletine, 600mg/day of mexiletine, or placebo (non-active study drug).   "
38517|NCT02781441|"     MDS are a diverse group of hematopoietic malignancies, which mainly occur in patients over 75     years of age. Incidence rate in 2012 in France was more than 6 cases per 100 000     person-years. MDS are characterized by ineffective haematopoiesis causing cytopenia, and by     leukemic transformation. The disease is heterogeneous, its pathophysiology complex and     clinical evolution variable.The few data available on MDS patients show how difficult it is     to understand MDS, its prognosis and the reasons for prescribing or not some treatments. In     the context of a highly complex potentially lethal disease such as MDS, it is of utmost     importance to optimize the information conveyed to patients. Particularly, 70.5% of MDS     patients surveyed in our developmental study would have preferred more information about     prognosis at diagnosis disclosure.      A simple intervention based on the use of a question prompt list (QPL), would greatly improve     the information process by helping patients to express their main concerns at their medical     consultations. Cultural differences may exist in the appraisal of QPLs and QPLs have not yet     been widely used in France.      However, in line with the previous results available in the literature and in a context a     priori favourable to the use of such an instrument, the investigators hypothesise that use of     a QPL will increase MDS patients' expressions of concerns and questions at their medical     consultations. Particularly the investigators assume that the discussion about prognosis will     be facilitated, without increasing anxiety because patients remain free to ask or not for     such information. The use of QPLs would also be a way to limit social inequalities related to     insufficient information and to encourage patient-doctor communication and meeting of patient     preferences which could lead to better health outcomes.   "
38518|NCT02781428|"     This is a prospective multicentre observational study to assess the sensitivity of the     UroMark assay to detect bladder cancer in participants with new or recurrent disease. The     study will recruit patients with newly detected or recurrent bladder cancer. The reference     standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade     1, 2 or 3 diseases with or without CIS, or CIS alone.      Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached     and asked to consent for this study. Consenting participants will be provided with a urine     sample collection kit and asked to provide a urine sample. Samples can be provided at home     and posted to the receiving lab using the stamped addressed envelope. The urine sample must     be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance     cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.      The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study     requiring provision of a urine sample, it will be possible for patients in DETECT II to be     recruited to other trials.   "
38519|NCT02781415|"     The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes     acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous     morphine in the management of acute severe pain syndromes (defined as a visual analogue scale     (VAS) score >/= 70) taking for example acute renal colic.   "
38520|NCT02781402|"     World Health Organization (WHO) defined body mass index (BMI) as the ratio of weight in     kilograms to the square of the height in meters (kg/m2). BMI has been used widely to diagnose     obesity as it is a simple method to be carried out and is also inexpensive. According to WHO,     there were 1.9 billion overweight individuals in 2014 with the age of 18 years old or above.     Of 1.9 billion overweight individuals, there were 600 million obese adults. The prevalence of     cardiovascular disease is higher among the overweight and obese individuals compared to     individuals with normal body mass index. This probably is due to altered cardiovascular     autonomic regulation. The risk of getting cardiovascular diseases is also higher among     physically inactive individuals. As much as 60% of American adults are not regularly active     and 25% of them are not active at all. Obese and overweight individuals tend to be physically     inactive and it has been shown that there is a negative relationship between BMI and heart     rate recovery (HRR). HRR is defined as difference in heart rate between maximum exercise and     1 minute later during recovery period after stopping of exercise. HRR after exercise stress     is due to withdrawal of sympathetic nervous system and the reactivation of parasympathetic     nervous system. Parasympathetic nervous system is altered in obese individuals therefore     leading to poor HRR after exercise. Aerobic training not only can reduce the body composition     but also improves the autonomic cardiovascular control. There is limited literature support     for any study which shows that potential of 4 weeks aerobic training can influence the heart     rate recovery in sedentary healthy adults. Most of studies conducted were using minimum of 6     to 8 weeks of aerobic training. The potential of 4 weeks of aerobic training in improving the     autonomic nervous system among sedentary adults is still unclear. Therefore, we hypothesized     in our study that there will be effect of 4 weeks of aerobic training on vagal modulation.   "
38521|NCT02781389|"     The aim of this non-interventional study is to provide further data on the utilization,     effectiveness, safety and clinical benefit including duration of response of Vismodegib for     treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or     radiotherapy and metastatic basal cell carcinoma (mBCC) under real world clinical conditions.   "
38522|NCT02781376|"     Obstructive Sleep Apnea (OSA) is prevalent in children and adolescents and associated with a     variety of negative consequences affecting health and cognitive functioning. While clinical     guidelines outline effective strategies for the diagnosis and management of pediatric OSA,     rates of screening, identification, and management in primary care settings remain low. The     aim of the current study is to evaluate the use of a computer decision support system module     (CHICA-OSA) designed to improve adherence to OSA guidelines in pediatric primary care     clinics. All children ages 1-11 years will be screened for snoring and other symptoms of OSA     in the waiting room prior to a visit to their primary care provider (PCP). In clinics     randomly assigned to CHICA-OSA, caregivers of snoring children will report on additional OSA     symptoms, and PCPs will receive automated prompts in the electronic health record (EHR) to     provide evidence-based evaluation and appropriate referral for testing. For children sent for     polysomnography (PSG), PCPs will receive automated prompts to reassess symptoms at the next     visit. We hypothesize that clinics using CHICA-OSA will have better adherence to guidelines,     as evidenced by higher rates of identifying OSAS, referral for PSG, and re-assessment     following treatment.   "
38547|NCT02781051|"     Pilot study to assess a multi-component intervention to increase physical activity among     breast cancer survivors with depression.   "
38523|NCT02781363|"     The Thoracic ultrasound is a safer and sensitive technique than conventional radiography     because it detects less than 1 cm pneumonic consolidations and minimal pleural effusions. The     main objective is to evaluate the efficacy of thoracic ultrasound performed by unskilled     personnel in the emergency service prdiatricas to diagnose pneumonia in children.   "
38524|NCT02781350|"     The main objective of this research is to investigate the effect of addition of fiber on the     high fat high carbohydrate (HFHC) meal induced inflammation and oxidative stress mechanisms     at the molecular level in humans, in vivo. The investigators have previously shown that the     intake of one HFHC meal leads to an increase in oxidative stress and inflammation. HFHC meal     also induces an increase in the expression of suppressor of cytokine signaling- 3 (SOCS-3) in     the mononuclear cells (MNC), which interferes with insulin signal transduction and     contributes to the pathogenesis of insulin resistance. In contrast, an American heart     association (AHA) meal rich in fruits and fiber does not induce these effects. These     observations are important since HFHC meal not only induces oxidative stress and inflammation     but also lays the foundations of a potentially greater insulin resistance through the     induction of SOCS-3, TLR-4 and TLR-2.   "
38525|NCT02781337|"     This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer.     Epidemiological data is collected. The Registry includes tumor tissue and blood banks for     analyzing different genetic mutations and disease-specific biomarkers.   "
38526|NCT02781324|"     The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone     scalpel (or osteotome device) with standard of care surgical instruments during posterior     spine fusion with instrumentation.   "
38527|NCT02781311|"     This study will evaluate the safety, tolerability and efficacy of the oral administration of     setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males     with androgenetic alopecia (AGA).   "
38528|NCT02781298|"     This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic     effect in infants.   "
38529|NCT02781285|"     The researching subject is aimed to obtain the clinical evidences (including real benefits，     risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by     compared with the outcomes that not accept the traditional Chinese medicine. the subject     acquires these clinical practices by using the methods of multicenter、persisting registry     (the real world researching technology ) and propensity score.   "
38530|NCT02781272|"     ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system     capable of harvesting rare circulating cells for analysis from a sample of peripheral blood     based on cellular size and deformability. In a small pilot study, scientists at the Medical     University of Vienna demonstrated that measurement of a combination of mRNA markers extracted     from CTCs captured using the Parsortix system could be used to identify women with ovarian     cancer. This study is designed to provide specimens for optimization of an assay using     clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor     markers) in combination with mRNA extracted from rare cells in the blood of women presenting     with a pelvic mass for the detection of malignancy.      Primary Objective: Optimization of an assay/algorithm for the differentiation of women with     benign pelvic masses from those with malignant pelvic masses using clinical and biomarker     information (i.e. demographics, imaging results and/or serum tumor markers) in combination     with mRNA markers extracted from rare cells isolated from whole blood. Multiple serum protein     markers and mRNA markers will be measured, and the results will be compared to the actual     clinical diagnosis made for each subject through other recognized methods (i.e.     histopathology). Statistical modeling will be used to combine the clinical information, serum     protein markers and/or mRNA markers for estimation of the risk of malignancy. If successful,     the resulting risk algorithm will be evaluated in future, appropriately powered, prospective     studies.      Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary     design of a mathematical algorithm to combine the clinical information, serum protein markers     and/or mRNA markers for estimation of the risk of malignancy.   "
38531|NCT02781259|"     In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine     green was performed during axillary lymph node dissection in breast surgery . By comparing     the concordance between the passage of indocyanine green and actual lymph node metastasis,     selective lymph node dissection can be developed.   "
38532|NCT02781246|"     Dexmedetomidine can prolong the duration of local anesthetics, but the effect of perineural     dexmedetomidine on the potency of ropivacaine for brachial plexus blocks in pediatric     patients has not been investigated. This study was designed to determine the effect of     perineural dexmedetomidine on ropivacaine for brachial plexus blocks in pediatric patients   "
38533|NCT02781233|"     This study evaluates the clinical impact of a progressive resistance training program in     adults patients with haemophilia   "
38534|NCT02781220|"     The main purpose of this study is to build upon the evidence captured in the Imaging Dementia     - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information     regarding patient-reported outcomes and physician confidence in diagnosis and management     based on the Implications for Management of PET Amyloid Classification Technology (IMPACT;     NCT number not yet assigned) trial design.   "
38569|NCT02780765|"     60 post operative patients who are kept intubated overnight & are spontaneously breathing     will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist     nebulizer.      Temperature of inspired gas at the Y piece will be measured.      Sterile water will be used for HH & Mist nebuliser.      The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/     doctor/trained personnel and additional suctioning if required.   "
38535|NCT02781207|"     This is a observational prospective study. For patients presenting to the Emergency     Department with loss of consciousness, emergency physicians will be asked to screen the real     syncope without an evident and immediate cause for the loss of consciousness (e.g. vasovagal)     and/or at least one high risk condition as listed by the European Society of Cardiology in     the 2009 Guidelines for the diagnosis and management of syncope (i.e. severe structural or     coronary artery disease, clinical or ECG features suggesting arrhythmic syncope, and     important co-morbidities).      In case of a real syncope not clearly physiopathologically explained and no high risk     conditions, the emergency physician in charge will check risk factors for high risk syncope     and categorize again every cases.      A high risk syncope is characterized by at least one high-risk characteristic (based on 2015     Syncope clinical management in the emergency department consensus): syncope during     exertion, in supine position, with new onset of chest discomfort, palpitations before the     loss of consciousness, family history of sudden death, congestive heart failure, aortic     stenosis, left ventricular outflow tract disease, dilated cardiomyopathy, hypertrophic     cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, left ventricular ejection     fraction <35%, previously documented ventricular arrhythmia, coronary artery disease,     congenital heart disease, previous myocardial infarction, pulmonary hypertension, previous     ICD implantation, anemia (i.e. Hb <9 g/dl), lowest systolic blood pressure in the ED <90     mmHg, sinus bradycardia (<40 bpm), new (or previously unknown) left bundle branch block,     bifascicular block plus a first degree AV block, Brugada ECG pattern, ECG changes consistent     with acute ischemia, a new non-sinus rhythm, bifascicular block, and a prolonged QTc (>450     ms).      Low and intermediate risk syncopes will be enrolled and evaluated using an integrated     point-of-care sonographic approach (based on history, physical exam, electrocardiogram, and     lung, focus cardiac and venous compression ultrasonography).      After discharge, the risk of patient's syncope will be determined by reviewing the entire     medical records.   "
38548|NCT02781038|"     Patients who smoke and suffer from fractures are worse off than those who do not smoke.     Orthopaedic patients represent a group that can benefit from physician contributions to     smoking cessation, and a special opportunity to cue this can begin with the orthopaedic     surgeon in the acute setting. However, the best way to appropriately counsel these patients     and assess the impact as a teachable moment remains undetermined.   "
38536|NCT02781194|"     The aim of this investigation is to assess the impact of forced air warming, warm humidified     insufflation gas and the combination of the two on intraoperative temperature maintenance and     the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid     following laparoscopic procedures (duration > 60 min) in a prospective, randomized,     controlled, double-blinded mono-centric study. Therefore 150 subjects will be randomized in 3     groups of 50 subjects each. First group will be treated with forced-air warming blanket (bair     hugger). Second group will be treated with warmed, humidified insufflation via the F&P     HumiGard™ Surgical Humidification System. Third group will be treated with both, warming     blankets and warmed, humidified insufflation. The peri-operative temperature of patients     might be higher in patients of the third group with the combination of both treatments. The     investigators hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage     will differ between groups. Wound infection incidence and time spent in PACU are also     expected to differ. Fibrinolytic activity in the peritoneal fluid is expected to be higher in     patients undergoing laparoscopic procedures with humidified gas insufflation, since the     trauma to the peritoneum will be less.   "
38537|NCT02781181|"     A recent randomized Carotid artery stenting (CAS) trial in which carotid protection device     (CPD)s were used to demonstrate equivalence with carotid endarterectomy (CEA) by achieving     noninferiority regarding periprocedural risk. However, the clinical efficacy and safety of     CPDs are still a matter of controversy. It has been argued that the limited reduction     provided by CPDs may be due to the devices themselves. Probably, they serve as sources for     emboli during the procedure or removal technique. In general, 30- day adverse outcome for CAS     with the use of CPDs seems not to be different from the outcome without CPDs.      Thus, the main goal in this study is to test the hypothesis that CAS without CPD usage is as     safe as in those patients who undergo CAS with CPD neuroprotection.   "
38538|NCT02781168|"     The aim of this study was to investigate the influence of the use of headphones in salivary     cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness     and handling NB, measure the concentrations of salivary cortisol before (baseline) and after     the use of hearing protection (response) in the neonatal intensive care unit (NICU).      A NICU nap periods and compare the influence of the use and non-use of hearing protection in     salivary cortisol levels and sleep patterns of infants during nap periods of the NICU.   "
38539|NCT02781155|"     This study investigates whether it is feasible to teach cancer patients undergoing     chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects.     Moxibustion is a therapy used in traditional Chinese medicine that uses heat.   "
38540|NCT02781142|"     Motor imagery training facilitates the neural plasticity with increasing the neuronal     cortical pathways in the brain. Motor imagery training is an effective way in stroke     survivors. However, its effects in persons with multiple sclerosis (MS) are not known.     Additionally, telerehabilitation based motor imagery training is very rare treatment way     which requires more research. Therefore, this study aims to investigate the effect of     telerehabilitation based motor imagery training on gait and balance performance of the     persons with MS.      The participants will be allocated into three groups, including motor imagery training,     wait-list control group, and age, gender, and education matched healthy control group. Each     group will include at least 25 participants (i.e. in total 75 participants).      All the assessments will be performed before and after the training in the 6-week motor     imagery training group. The participants in the wait-list control group will underwent the     assessment with a 6-week interval. The healthy participants will be assessed only one.      The motor imagery training will be designed for the individual basis with following standard     protocols. It will be applied three times a week for 6 weeks. The first three sessions will     be performed in the clinic, the other will be performed at the patients' home with a     telerehabilitation technique.   "
38541|NCT02781129|"     This study is designed to identify brain activity associated with good memory in subjects     with a chronically implanted RNS® device and to study the effects of therapeutic stimulation     for epilepsy on memory. This will be accomplished through analysis of ECoG data collected     during memory encoding for short and long-term free recall as well as during navigation     tasks.   "
38542|NCT02781116|"     This study will have great impact and influence in the medical setting as the targeted model     that will be derived from this study will be the pioneer in our region. This model will be     beneficial in identifying risk factors and its association with the Arab women population.     Furthermore, it will bring chemotherapy prevention once the risk factors and the model are     established. Risk factors maybe different from those identified in western women by Gail and     IBIS Models   "
38543|NCT02781103|"     This is a single blind, randomized controlled pilot trial of transcranial direct stimulation     (tDCS) intervention or tDCS sham administered with a standardized guided imagery     intervention. Up to 25 adult women with chronic pelvic pain will be enrolled and randomized     (like a flip of the coin) to achieve a total sample size of 20 women. 10 women in one arm of     the study will receive guided imagery with tDCS stimulation. 10 women in the other arm of the     study will receive guided imagery with sham tDCS. Subjects will remain blinded until the end     of the study.   "
38544|NCT02781090|"     This trial will compare the efficacy of Positively Smoke Free on the Web+ (a smoking     cessation program + social network for HIV-infected smokers) to the American Heart     Association Getting Healthy website in promoting abstinence in a group of HIV-infected     smokers. All participants will be offered a three-month supply of nicotine patches.   "
38545|NCT02781077|"     In an observational study, the energy consumption of stroke individuals during performing the     structured, progressive task-oriented exercise program for walking rehabilitation will be     measured in order to confirm the intensity demand in the range of moderate to vigorous.   "
38546|NCT02781064|"     Statins are known to cause rare but serious side effects such as rhabdomyolysis (breakdown of     muscle tissue) but many patients stop taking statins due to less severe symptoms, such as     muscle pain or fatigue.      This study aims to determine whether symptoms occurring during statin use are caused by     statins. The trial will compare patient-reported side effects of statins (20mg atorvastatin)     vs. placebo.      Patients will be randomized to alternating treatment blocks of either statin or placebo split     into six two-month treatment periods. At the end of each period, patients will be asked to     self-report side effects using a website or mobile app.   "
38550|NCT02781012|"     This sample-collection study is open to participants in several categories: healthy     volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed     with pancreatitis or any stage of pancreatic cancer. All participants will submit urine,     saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit tissue     samples if biopsy/ies or surgery is part of the care being provided by their doctor. In     partnership with Berg Health, LLC, biomarkers will be investigated for potential use in early     detection of pancreatic cancer, to determine prognosis of patients, and to find the most     appropriate treatments for patients.   "
38551|NCT02780999|"     The aim of this study is to compare the effect of Whale and Colditz static orthosis on pain     and functional abilities of hand in thumb carpometacarpal osteoarthritis as a unique     treatment.      Patients with thumb CMC OA will be recruited at Tecan Hand Center Clinic. Participants will     be assigned using a randomized allocation in two groups. For group A a Whale orthotic will     be constructed and for group B a Colditz orthotic. Both static splint will endorse for 3     months. Inclusion criteria for this study were adult over 18 diagnosed with carpometacarpal     joint osteoarthritis with a pain intensity during Activities of Daily Living (ADL's) up to 4     / 10 on the Visual Analog Scale (VAS).      Patients were excluded from participation if they had: a neurological disorder affecting the     upper limb; had received previous treatment for their hand problem in the last 6 months     including an intra-articular joint injection to wrist, fingers or thumb; had fractures or a     significant hand injury or previous surgery to the wrist or hand; had hand or finger     tenosynovitis and/ or Dupuytren's disease. Were also excluded patients who did not complete     Dash Spanish version questionnaire or if they did not sign the informed consent.      The outcome measure will be pain intensity and functional abilities as measured with the     Visual Analogue Scale (VAS) and Disabilities of the Arm, Shoulder and Hand (DASH),     respectively. All measures will be collected at baseline and end of the intervention.   "
38552|NCT02780986|"     The investigators aim to assess the efficacy of a multi-component intervention on condom use     and sexually transmitted infection (STIs) in female entertainment workers and men frequenting     entertainment establishments (EEs), using a quasi-experimental design. Joo Chiat and Golden     Mile Complex will be selected purposively as control cluster sites (n=220) with follow-up of     entertainment workers at 6 weeks. The same sites will be used as intervention sites after a     3-months 'wash out' period. Self-reported condom use, vaginal swab samples for polymerase     chain reaction (PCR) for cervical gonorrhoea and chlamydia infections, and throat swabs for     culture for pharyngeal gonorrhoea will be assessed. Clark Quay will be the intervention venue     for the heterosexual men while Tanjong Pagar will be the equivalent control site. Using time     location sampling, cross-sectional samples of men patronising these establishments will be     assessed on self-reported condom use at baseline (n=600) and 6 months after the intervention     (n=400) in both intervention and control groups.   "
38553|NCT02780973|"     Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples     once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is     measured after extraoral erosion.      Total protein concentration within the formed salivary pellicles on the bovine samples is     determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH,     buffer capacity, albumin and total protein content as well as concentration of inorganic     calcium, phosphate and fluoride) are being measured.      The aim of this study is to investigate whether gender differences in the salivary     composition correlate with predisposition to erosion.   "
38554|NCT02780960|"     The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in     detecting residual/recurrent disease in women treated by loop electro-surgical excision     (LEEP) for CIN1+.   "
38555|NCT02780947|"     Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation     reduces appropriate defibrillator therapies.   "
38556|NCT02780934|"     The purpose of this study is to determine whether using a pressure- vs. simple adhesive     dressing affects the postoperative course and wound healing outcomes following Mohs surgery.   "
38580|NCT02780622|"     This is an open-label, randomized, 2-period crossover study, to evaluate the     pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with     Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized     to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and     warfarin followed by warfarin. The treatment periods will be separated by a washout period of     at least 4 days. Participants will continue receiving warfarin once daily at a prescribed     usual dose throughout the study.   "
38557|NCT02780921|"     Perioperative chemotherapy is the gold standard treatment in the resectable and advanced     gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two     randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and     evaluates chemosensitivity. Disease free and overall survival rates were significantly     improved with perioperative chemotherapy compared to surgery alone. However, the limitation     of these studies is that among all patients requiring chemotherapy, almost 70% of patients     will not have the complete sequence. This sequence is defined by the administration of 2 to 4     cycles before and 2 to 4 cycles after the surgery, according to the protocol. The major cause     of absence or impossibility of realization of postoperative chemotherapy was the presence of     postoperative complication, postoperative serious asthenia and impaired nutritional and     physical status (1,2). Poor physical condition assessed by cardiopulmonary exercise testing,     reflecting a reduced physiological reserve, is predictive of postoperative complications     (3,4). A physical training, even during a short period and on a various population, is     beneficial in improving physical condition, cardiopulmonary function and muscular mass of the     patient (5-8). A prehabilitation over a 6 week period between surgical consultation and     surgery decreases postoperative morbidity and the hospital stay in cardiovascular surgery but     no study has ever been performed in the gastric or oesophageal cancer (7,9).      Prehabilitation revolves around three axes: 1) a physical training based on initial     cardiopulmonary exercise testing (VO2peak, anaerobic threshold (AT) and 6-min walk test     (6MWT)), 3 times by week, supervised by a physical therapist 2) a nutritional care to ensure     the compliance of the nutrition program and adapt the nutritional management based on protein     and energy needs and on the level of spontaneous oral intake and 2) a psychological treatment     by a psychologist to reduce preoperative anxiety. To our knowledge, no study ever focused on     the gastroesophageal cancer. The benefit of prehabilitation in this cancer may be     particularly important because 1) this surgery is associated with a high postoperative     morbidity (40%, especially respiratory) and mortality (5%) 2) the physical and nutritional     status of these patients is often precarious (cancer cachexia, gastroesophageal obstruction),     and 3) the need to preoperative chemotherapy declines physical reserves and is associated     with a lengthening of the time between consultation and surgery of more than 3 months (10).     Also, the investigators hypothesize that with a physical training, a personalized nutritional     support and a psychologist management may decrease postoperative complications, increase     postoperative nutritional status and so, would allow for more patients to receive their full     cancer treatment. The aim of this study was to evaluate, in gastroesophageal adenocarcinoma,     the effect of prehabilitation compared to conventional care, the percentage of patients     reaching the complete oncological treatment decided in a multidisciplinary tumour board.   "
38558|NCT02780908|"     This project will consist of two studies, each investigating resting and exercise     cardio-respiratory responses during exposure to hypoxia in individuals born prematurely and     individuals born at full term of two different age groups: Kids (10-14 yrs) and Adults (18-22     yrs).Additional study will be performed on a preterm adult cohort (15 participants) that will     investigate potential differences between hypobaric and normobaric hypoxia as outlined in the     following section.   "
38559|NCT02780895|"     Implantation of Celavie human stem cells (OK99) is intended to address the underlying     pathology of the disease by replacing damaged/destroyed cells of the brain, and/or     stimulating the patient's brain to repair itself.   "
38560|NCT02780882|"     The purpose of this prospective open-label phase II study, is to evaluate the efficacy of     pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol     in patients with ectopic ACTH-producing tumors as measured by the proportion of patients     achieving normal UFC at the end of the study period.   "
38561|NCT02780869|"     The purpose of this prospective, randomized, controlled study is to evaluate the safety and     efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device,     absorbable gelatin sponge USP with thrombin.   "
38562|NCT02780856|"     This is a prospective, multi-centre clinical study to evaluate the safety and performance of     the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either     sound (inactive) or unsound (active caries lesion present) according to ICDAS staging     (International Caries Detection and Assessment System). Images of the tooth surface will be     taken with the Calcivis System immediately before and after application of a disclosing     solution containing a bioluminescent protein. Presence or absence of elevated luminescence on     the images will indicate activity / inactivity of the presence or absence of active     demineralisation on the tooth surfaces.      The study will be deemed a success if there is 70% agreement and above between:        1. elevated luminescence and the presence of active caries as determined by the dentists,          and        2. absence of luminescence and the determination of a sound tooth surface by the dentists.   "
38563|NCT02780843|"     Acute stroke occurs in approximately 13.000 persons every year in Denmark, 10 - 15 % now     receives intervenous thrombolytic therapy, which remains the most important acute treatment     in ischaemic stroke. For more than a decade there has been an ongoing discussion if     Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) were best before     thrombolysis: Magnetic Resonance Imaging is superior in visualising ischaemia, but     Computerized Tomography is quicker and more easily applicable.      In the investigators centre primary imaging in work up of acute stroke during working hours     will alternate between Computerized Tomography and Magnetic Resonance Imaging days based on a     fixed calendar for a 24 months period as a quality development project.      This study is planned to include patients who have acute stroke imagining during this period,     a total of 600 patients is expected. The investigators will compare door-to-needle time,     patient safety, quality of imaging, patients' experience, physicians' decision certainty, and     use of recourses.   "
38564|NCT02780830|"     This is a modular study of AZD2014 in combination with novel anti-cancer agents in patients     with different subtypes of relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).     Module 1, a combination with ibrutinib in patients with non-germinal centre B-cell-like     (non-GCB) DLBCL, will consist of Part A, a Phase I dose-finding arm in which the safety and     tolerability of the combination will be assessed, and Part B, a Phase II dose-expansion phase     to assess the efficacy of the combination.   "
38565|NCT02780817|"     Inducing a systematic perturbation forces on the hand during arm reaching movement may     improve adaptation. Error-augmentation (EA) training is relatively new concept in motor     learning intended to promote the adaptation process. In this study participants will practice     one session of training on 3D robotic device. Healthy volunteers will be randomly divided     into two groups: study and control. The study group will carry out the training session with     EA forces. The control group will carry out the same procedure with null force field. Outcome     measure are the average size of trajectory error from the straight line and level of exertion     (borg scale).   "
38567|NCT02780791|"     The purpose of this study is to determine whether the pelvic wall or the ovary represents a     better location for the maturation of follicles in the context of ovarian transplantation     after cryopreservation of ovarian tissue before cytotoxic therapies.   "
38568|NCT02780778|"     The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the     efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced     Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.   "
43914|NCT02710864|"     The primary objectives of this study were to evaluate the incidence of congenital CMV     infection in neonates, and assess the concordance of detecting congenital cytomegalovirus     (CMV) infection in neonatal saliva and urine samples.   "
38570|NCT02780752|"     Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary ducts     in the liver resulting in destruction and fibrosis. PSC is associated with increased serum     levels of hyaluronan (HA), an extracellular matrix polymer known to drive inflammation in     multiple other tissues and disease models. Inhibition of HA synthesis with oral hymecromone     has been shown to prevent progression of autoimmunity in several animal models. This is a     prospective, open-label, single-center, pilot safety study of hymecromone in adults 18 years     of age or older diagnosed with primary sclerosing cholangitis without evidence of hepatic     fibrosis. Participants will be treated for 6 months with study drug. Safety and biomarkers of     response will be monitored during therapy.   "
38571|NCT02780739|"     Adaptive reasoning and problem-solving are critical skills that allow for accurate decisions     to be made based on varying levels of information. In many situations these decisions must be     made and communicated under stressful, time-sensitive conditions. In such contexts, an     ability to apply inductive and deductive reasoning to complex, ambiguous, and/or novel     problems is critical. The objective of the INSIGHT project is to establish a comprehensive     and rigorous brain training protocol to significantly improve adaptive reasoning and problem     solving. We will examine a variety of interventions (cognitive training, physical fitness     training, physiological stimulation, , and combinations thereof) to assess their ability to     improve adaptive reasoning and problem solving abilities. Multimodal interventions are     hypothesized to act synergistically to significantly enhance fluid intelligence (Gf) and     underlying brain structure and function.   "
38572|NCT02780726|"     The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal     dialysis chronic kidney disease patients with anemia.   "
38573|NCT02780713|"     This is a phase 1 open label single centre study of AZD9496 administered orally in healthy     volunteers. The study design involves single administration of different forms, formulations     and doses of AZD9496. The study is designed to investigate these different AZD9496 variants.     The study will evaluate the pharmacokinetic profiles and the safety and tolerability of the     different forms, formulations and doses of AZD9496      This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers.     Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and     doses.   "
38574|NCT02780700|"     The objective of this Phase II study is to assess the efficacy and safety of nintedanib alone     or in combination with capecitabine for patients with refractory mCRC after failure of at     least 2 lines of standard treatment   "
38575|NCT02780687|"     The purpose of this trial is to assess the anti-tumour activity and safety of afatinib     monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 mutations or     ERBB2 amplifications (Cohort A), and EGFR amplification positive tumours (Cohort B),     progressing despite previous platinum based chemotherapy, and thereby to improve their     prognosis.      The antitumour activity of afatinib monotherapy in these patients will be assessed by     progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the     trial. A key secondary endpoint will also be defined, the objective response rate (ORR).   "
38576|NCT02780674|"     To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734     in adult subjects with type I interferon-mediated autoimmune diseases.   "
38577|NCT02780661|"     This method development study will be a two treatment arm, randomized, cross over study in a     population with edentulous upper arch restored with a maxillary complete denture. The lower     may be a partial or full edentulous mandibular arch that may be restored with a stable     complete, partial or implant supported denture.   "
38578|NCT02780648|"     This is a single center, single arm unblinded prospective study of the safety of pancreatic     stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline     resectable, or recurrent pancreatic/periampullary cancers who have previously undergone     treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated     radiation treatment, or any combination of these therapies.      Primary Objective      • To estimate rates of acute (within 3 months of treatment) grade 3 or greater     gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for     pancreatic or periampullary cancers who have previously received other treatment.      Secondary Objectives        -  To estimate rates of late (> 3 months after treatment) grade 2 gastritis, enteritis,          fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in          patients treated with Linac-based SBRT for pancreatic or periampullary cancers        -  To estimate rates of local progression, overall survival, metastasis-free survival, and          progression-free survival in patients with pancreatic or periampullary cancers treated          with fractionated Linac-based SBRT.        -  To evaluate the ability of Linac-based SBRT to provide pain control in patients with          pain related to a pancreatic or periampullary tumor.        -  To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for          pancreatic or periampullary cancers.   "
38579|NCT02780635|"     In layperson's language state the purpose of the study in 3-5 sentences.      Previous research has demonstrated that intimate partners can positively influence those with     PTSD to seek treatment. The investigators have preliminary evidence to demonstrate that     mobile apps, such as PTSD Coach can be helpful for those with PTSD, and the current study     will provide Veterans with PTSD and their partners with a mobile app designed to promote     engagement with evidence-based treatments for PTSD. The purpose of this PILOT study is to     evaluate methods for delivering a couples-based intervention to reduce PTSD symptoms and     improve relationship quality in Veterans and their intimate partners.      b) State what the Investigator(s) hope to learn from the study. Include an assessment of the     importance of this new knowledge.      Understanding ways to improve the public health impact of public-facing, evidence-based     mobile apps is critical. This study will test a low-cost, high-touch approach to improving     the outcomes associated with use of the PTSD Coach and PTSD Family Coach mobile apps,which     are already available to the general public and used by over 55,000 new users per year.This     study will test whether the involvement of an intimate partner in the use of a mobile app for     PTSD will result in changes in how the mobile apps are used and in relationship quality and     PTSD symptoms over time. Additionally, this study will test whether the addition of a     discussion board can improve engagement with the apps and/or outcomes. The study will also     provide useful qualitative data that can inform the development of subsequent dyadic     interventions using mobile technologies.      c) Explain why human subjects must be used for this project. (i.e. purpose of study is to     test efficacy of investigational device in individuals with specific condition; purpose of     study is to examine specific behavioral traits in humans in classroom or other environment)      The purpose of this study is to evaluate how Veterans and their partners interact with     evidence-based mobile apps for improving PTSD symptoms.   "
38581|NCT02780609|"     Phase I: The primary purpose of this study phase is to determine the best dose also referred     to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose     melphalan as a conditioning regimen for hematopoietic cell transplant.      Phase II: The primary purpose of this study phase is to assess the complete response (CR)     conversion rate.   "
38582|NCT02780596|"     This study aims to:        1. identify which single item or combination of two items perform best in identifying          problematic infant night wakings and        2. describe current practices by pediatricians in addressing problematic infant night          wakings.      Using a novel computer decision support system in several primary care clinics, caregivers     accompanying their child to a health visit will be randomly assigned to receive two of five     items assessing night wakings and/or sleep problems, followed by a validated questionnaire     for infant night wakings. If caregiver responses to the items suggest a possible sleep     problem, pediatricians will receive a prompt in the electronic health record identifying a     possible infant sleep problem. A sub-sample of caregivers will then be interviewed regarding     the content of the visit that day.   "
38663|NCT02779530|"     Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the     association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of     non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2     V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the     sample size planned, a mean difference of total body water delta between groups (control vs.     polymorphic) of at least allow 10% could be observed.   "
38583|NCT02780583|"     The primary purpose of this study is to determine whether giving injections of anakinra is a     safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for     patients who are admitted to the hospital with signs of severe inflammation (macrophage     activation syndrome) that is potentially life-threatening. Anakinra is a commercially     available product (Kineret™) approved for the treatment of rheumatoid arthritis; it is a     replica of a naturally occurring protein called Il-1 receptor antagonist (IL-1ra), made by     humans to inhibit and regulate the action of interleukin-1 (IL-1). IL-1 is a mediator of     inflammation that when generated in excess amounts by immune system cells can result in     severe dysfunction of multiple organs that can be life-threatening. The specific primary     objectives of the study are to determine if giving anakinra results in no increased infection     complications or mortality. Additional data will be collected to determine whether anakinra     administration results in any other unanticipated side effects in this setting, and the     effects of anakinra administration on inflammation markers, the overall dose of steroids     required to treat the inflammation, and the length of hospital stay.   "
38584|NCT02780570|"     Guillain-Barré syndrome (GBS) is the commonest form of acute flaccid paralysis and the     incidence is high in low-income countries. In Bangladesh, most GBS patients are poor.     Therefore patients cannot afford expensive specific treatments like intravenous     immunoglobulin (IVIg) or plasmapheresis (PE) in part explaining the high mortality and     disability compared to treated patients in high-income countries. Added difficulty in     traditional PE is its unavailability and specialized device and manpower dependency. Most     research in GBS has been conducted in high-income countries, largely in patients with a     demyelinating form of GBS. Axonal form of GBS is common in low-income and Asian countries     which has a different pathogenesis, clinical course and outcome than the demyelinating form.     Very few therapeutic studies have been conducted in low-income countries due to expensive     existing modalities of treatment. Here, the investigators propose SVPE as a treatment for GBS     in patients from low-income countries. SVPE is relatively cheap, can be done at the bedside     without any special device or electricity and eventually is expected to help poor severely     affected GBS patients in underdeveloped and developing countries. The main outcomes will be     the safety and feasibility of SVPE since this is yet to be established in the resource     limited settings. To be able to evaluate the safety of SVPE, additional information will be     acquired about the frequency of complications in non-GBS patients with a central line,     treated during the same time period at the same study facility as the GBS patients. Severe     sepsis due to central line associated blood stream infection and deep venous thrombosis in     the limb where the central venous catheter will be inserted during or following the SVPE     procedure, will be defined as severe adverse effect (SAE) and will be considered as primary     outcome measure for safety. Blood, cerebrospinal fluid and other relevant biological     specimens will be analysed for diagnosis and screening for infections. In addition clinical     and neurological outcome assessment will be monitored until discharge of the patient from the     hospital and up to four weeks since study entry. Confirmation of feasibility and safety, will     eventually lead to a randomized control trial in future with a primary focus on the clinical     efficacy of SVPE for the treatment of GBS in developing countries as an alternative for the     conventional treatment with IVIg or PE.   "
38585|NCT02780557|"     The aim of this project is to test whether giving parents advice about book reading is     effective in promoting language learning for infants from a range of socio-economic     backgrounds.   "
38586|NCT02780544|"     Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered     in time, the disease can be treated, and impaired vision or blindness can be reduced.     Premature infants are therefore examined regularly after birth. However, the examination is     painful and stressful for the infant. Painful experiences might lead to a pathological stress     response later in life and should therefore be prevented.      In this study skin-to-skin contact with a parent is tested for relief of pain and stress in     preterm infants being examined for retinopathy of prematurity.   "
38587|NCT02780531|"     The purpose of this study is to identify genetic or other factors in the subjects blood that     may predispose them to getting a particular disease or tell researchers how the disease will     behave, for example how fast it will progress or what areas of the body might be affected. A     second goal is to relate such factors to how such a condition affects the subjects clinically     as well as how it affects the electrical functions of nerves and muscles.   "
38588|NCT02780518|"     Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to     patients when they are paralysed under general anaesthesia. Their lungs are not moving, but     the high flow allows oxygen to travel into their lungs. This is called 'apnoeic ventilation'.     The investigators will be using this for patients undergoing surgery for their throat.   "
38589|NCT02780505|"     Among patients with chronic kidney disease (CKD), there is association between anemia and     increased chance of mortality mainly because of cardiovascular diseases and stroke, risk of     hospitalization, and death prevalence in predialysis patients. Vitamin C plays an important     role in iron metabolism and application for red blood cell formation. Infusion of ascorbate     supplementation can reduce oxidative stress among hemodialysis patients. This study aimed to     assess the effect of vitamin C on patients with continuous ambulatory peritoneal dialysis     (CAPD).   "
38590|NCT02780492|"     Novel emerging therapies for Duchenne Muscular Dystrophy (DMD) require a deeper understanding     of DMD natural history. This study aim to assess the natural history of DMD through a     composite assessment tool capable of capturing disease progression linking ambulant and     non-ambulant phases of the disease.   "
38714|NCT02778867|"     The purpose of this interventional study is to test and compare the effectiveness of two     elimination diets—the 1-food elimination diet (1FED, milk only) and the 6-food elimination     diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also     test the effectiveness of swallowed glucocorticoid therapy in some of the study participants     for whom diet therapy was not effective.   "
38592|NCT02780466|"     Septic shock is common in intensive care and its mortality remains high. While new treatments     have not improved survival, optimization of known and widely used techniques has allowed     reduction in mortality. Thus improving care given to patients starts with making better use     of existing resuscitation techniques. Among these practices, mechanical ventilation is     widespread in the management of patients with septic shock. In large studies published in     recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical     ventilation. It therefore appears that a significant proportion of patients are never     intubated during treatment and management of their septic shock. There is no specific     recommendation from critical care societies concerning mechanical ventilation in the     treatment of septic shock. Apart from indisputable situations such as impaired consciousness     or acute respiratoire distress, the decision whether to ventilate mechanically or not is left     to the discretion of the physician.      The aim of this study is to analyze intubation practice in septic shock patients and its     impact on 28-day survival.      This multicentric and observational study will be conducted in 30 French ICUs.   "
38593|NCT02780453|"     Laparotomy wounds are associated with high rates of surgical site infections (SSI). The     effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is     inconclusive.   "
38594|NCT02780440|"     The purpose of this randomized controlled study is to        1. Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan          area;        2. Evaluate the effectiveness of home MT versus traditional home exercise program; and        3. Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic          stroke subjects with moderate hand deficits. Subjects from occupational therapy at the          Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular          accident (CVA) or stroke will be divided into three (3) groups:             -  Control Group subjects will participate in standard occupational therapy               rehabilitation protocol plus a traditional home based exercise program.             -  Experimental group 1 subjects will participate in standard rehabilitation protocol               plus unimanual home based mirror therapy program             -  Experimental group 2 subjects will participate in standard rehabilitation protocol               plus bimanual home based mirror therapy program.   "
38595|NCT02780427|"     The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus     have not been described for sedation in children undergoing transthoracic echocardiography     (TEE) study. This information is important to compare agents and to determine the most     effective sedative dose. The investigators performed a two-stage study to determine the ED50     and the ED95 of intranasal dexmedetomidine to investigate age-related differences in     participants undergoing transthoracic echocardiography study.   "
38596|NCT02780414|"     Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement     that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S.     pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the     current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method     has emerged that more accurately identifies women at risk for preeclampsia, warranting     improvements in diagnosing Pre-E.      This sample collection study will obtain serum and urine samples from pregnant women who     present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E.     Samples will be used to evaluate and validate the performance of an assay intended to aid in     assessing the risk of Pre-E.   "
38597|NCT02780401|"     This phase I trial studies the side effects and best dose of a vaccine therapy in preventing     cancer from coming back in patients with non-metastatic, node positive, human epidermal     growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have     disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an     effective immune response to kill tumor cells. Giving multiple vaccinations may make a     stronger immune response and prevent or delay the return of cancer.   "
38598|NCT02780388|"     The purpose of this study is to determine whether MEDI4920 is safe and tolerable in patients     with adult-onset rheumatoid arthritis.   "
38599|NCT02780375|"     Peripheral blood samples will be taken with informed consent from radiotherapy patients     undergoing standard radiotherapy at The Royal Marsden before and during treatment for breast,     lung, gastrointestinal and genitourinary tumours. Responses from panels of up to 800 coding     and non-coding RNAs will be assessed in the samples using the nCounter system. Candidate     genes identified by Public Health England, Columbia University and/or in the literature as     being specific to radiation responses will be included, together with genes relevant to     systemic inflammatory responses, to identify transcriptional responses for a range of doses     and exposures on an inter-individual basis. Data will be analysed using existing and new     statistical tools focused on count data modelling. The intended outcome is identification of     a radiation specific panel of genes to inform individual radiation responses and if the     results are favourable, a large scale follow up to this proposed pilot is expected in due     course.   "
38600|NCT02780362|"     An open label randomized, single dose, two-way crossover bioequivalence study to determine     the bioequivalence of Daclatasvir from Prodactariv 60 mg F.C.T (International Drug Agency for     Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma,     UK) in Healthy Human Volunteers Under Fasting Condition   "
38601|NCT02780349|"     Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower     extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)   "
38602|NCT02780336|"     The aim of this study is to develop new rating scales to help diagnose and measure the     severity of blepharospasm. This is a condition involving a lot of blinking and spasms of eye     closure that people can't control. This study will also test some video software to see if it     can help diagnose people or tell the severity of disease using only a video recording of an     exam. There is an additional plan to create an educational video to teach others the proper     use of the scale and video software.   "
38603|NCT02780323|"     This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX®     in Rheumatoid Arthritis Patients   "
38715|NCT02778854|"     The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid     biopsy in different specimens and in different methods compared with tissue detection .   "
38604|NCT02780310|"     The purpose of this study is to find out what effects, good and/or bad, the drug lenvatinib     has on the patient and on adenoid cystic carcinoma. This type of cancer study is called a     phase II study. Researchers hope to learn if the study drug will shrink the cancer by at     least one-quarter compared to its present size.      Lenvatinib is an oral medication that can interfere with cancer cell growth and reduce the     growth of blood vessels around tumors. This study will help find out if lenvatinib is a     useful drug for treating patients with adenoid cystic carcinomas.   "
38605|NCT02780297|"     The purpose of this study is to determine the natural history of the hereditary forms of     nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria,     Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric     hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation     and determine relationship to the disease course. Cross-comparisons among the disorders will     allow us to better evaluate mechanisms of renal dysfunction in these disorders.   "
38606|NCT02780284|"     The purpose of this study has 2 aims:      Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of     colorectal cancer to a physical activity intervention trial. Investigators hypothesize that     it will be possible to recruit and retain this patient population to a physical activity     intervention trial.      Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and     analyzing the gut microbiome data. Investigators hypothesize that all of these steps are     feasible.   "
38607|NCT02780271|"     We will conduct a 2x2 factorial randomized controlled trial to test the separate and     synergistic effects of an in-person hands-on dietary and physical activity change curriculum     (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed     newsletters and an interactive website) on changing dietary and physical activity behaviors     among a diverse population of Latina breast cancer survivors who have completed breast cancer     treatment. Participants will be evenly randomized to 4 arms: in-person education alone,     e-communication alone, in-person education plus e-communication, or control.   "
38608|NCT02780258|"     To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands   "
38609|NCT02780245|"     This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose     versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum     hemorrhage at secondary CS.   "
38610|NCT02780232|"     Major depression is a highly prevalent and severe mental disease. Interventions based on     information and communication technologies (ICTs) generate innovative opportunities to     prevent and to intervene early the depression in adolescents. In Colombia, there are few     preventive mental health interventions scientifically oriented and seeking to demonstrate     efficacy in context.      The purpose of this study is to determine whether an internet-based program is effective to     prevent and to intervene early the depression in adolescents between 13 and 19 years of age     in 8 schools of the Antioquia Region, Colombia .      Study design: A cluster-randomized clinical trial will be carried out with 600 adolescents.     The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A     single-blind randomized controlled trial will be conducted with two arms, the intervention     arm (n=300), which will receive an internet-based program for depression, and the TAU     (Treatment As Usual) arm (n=300).   "
38611|NCT02780219|"     For this study a resistance bout will be performed in order to promote the robust response of     protein synthesis. Type II muscle fibers often exhibit more atrophy than type I fibers in     COPD subjects therefore specifically targeting them in an exercise protocol could have more     beneficial outcome for these individuals.   "
38612|NCT02780206|"     Understanding how foods and nutrients are digested, absorbed and metabolized when weight is     stable and during weight loss induced by very low calorie diet procedure using the     technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics (omics)     will enable generation of new hypotheses that could explain the inter-individual differences     in weight loss and could lead to optimization and individualization of therapies designed to     lose weight.   "
38613|NCT02780193|"     The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance     in subjects with prolonged parenteral nutrition dependence and parenteral     nutrition-associated cholestasis through expanded access.   "
38614|NCT02780180|"     Heart Failure (HF) a common clinical condition characterized by either by a heart that does     not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive     cardiac remodeling and dysfunction.      A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway,     may lead to improve HF.      QCG001 is a prodrug of EC33, a aminopeptidase A (APA) inhibitor. QCG001 has been shown to be     an antihypertensive agent in animal models.      This study investigates the safety and efficacy of QGC001 in HF patients.   "
38615|NCT02780167|"     Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily     (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the     efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of     the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease     severity in patients with moderate to severe AD as measured by the Investigator's Global     Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support     further clinical development of PF 04965842.   "
38616|NCT02780154|"     This is a single center, randomized and controlled human study to optimize controlled human     malaria infection (CHMI) administered by direct venous inoculation (DVI). 36 healthy adults     aged between 18 and 45 years, will be randomized to one of five groups and will be inoculated     with PfSPZ Challenge DVI. Participation duration is estimated to be 2 months, while the study     duration is planned to be 4 months. The primary objective of this study is to assess the     safety and reactogenicity of PfSPZ Challenge administered by DVI using 7G8 and NF54 P.     falciparum strains.   "
38617|NCT02780141|"     The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive     hemodialysis chronic kidney disease patients with anemia.   "
38759|NCT02778282|"     The goal of the MySafeRx study is to evaluate the feasibility, acceptability, and usability     of a novel platform that integrates text messaging reminders, secure electronic pill     organizers, and daily remote brief motivational recovery support visits with a standardized     protocol for supervised self- administration of buprenorphine via videoconferencing.   "
38618|NCT02780128|"     The purpose of this research study is to match genomic aberrations in tumor cells at time of     relapse to rationally designed combinations of molecularly targeted agents. This study will     be done in two parts:      Part I: Tumor will be accessed at study entry via a biopsy and subjected to deep sequencing     to identify protocol-specified biomarkers for therapy assignment.      Part II: If the tumor contains a genetic change defined by the study as being actionable, and     other criteria are met, participants will be assigned to therapy based upon the genetic     changes identified in the tumor biopsy.   "
38619|NCT02780115|"     This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201     and AGN-190584 in participants with presbyopia (inability to focus on items close-up).   "
38620|NCT02780102|"     The investigators administered a randomized controlled trial (RCT) through random assignment     of children with ADHD into three different groups to compare the effects of cognitive-motor     rehabilitation, immediate release methylphenidate, and an active control on the executive     functioning, learning, and behavioral symptoms of children with ADHD.   "
38621|NCT02780089|"     This study evaluates the different patterns of care for patients who have unresectable or     metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be     observed. The survival rate of these patients will also be observed.   "
38622|NCT02780076|"     The survivors after hip fracture often report severe pain and loss of physical functioning.     The poor outcomes cause negative impact on the person's physical functioning and quality of     life and put a financial burden on society. It is important to continue and progress the     functional training that already started at the hospital, while the patients are transferred     to short-term stays in a nursing home before they are returning to home. The aim presently is     to examine the effects of a functional training program by a RCT design, initiated by the     physiotherapist and performed by the nurses, on physical functioning while the patients are     at short term stays in primary health care.   "
38623|NCT02780063|"     Prior to cataract surgery the lens must be calculated to appropriately fit a patient for the     intraocular lens implant. Lenstar is an optical biometer that calculates the axial length,     keratometry, lens thickness, pupillometry, and anterior chamber depth. Dilation drops are     routinely used in eye exams in addition to pre-cataract surgery. The dilation drops include     Tropicamide 1%, and Phenylephrine 2.5%. The Tropicamide achieves the dilation of the pupil     which causes an anterior rotation of the ciliary body, which may affect the Lenstar     measurements. This study is to determine if dilating medications affect the lens power     prediction for emmetropia by the Lenstar biometer. Prior to dilation, Lenstar biometry will     be performed on each eye. Patients will receive dilation medication and after waiting 20     minutes Lenstar biometry will be performed on each eye. Dilation and measurement with Lenstar     will be done as standard of care. Measurements and calculations from before and after will be     compared.   "
38624|NCT02780050|"     Chest compression, a key component of cardiopulmonary resuscitation (CPR), has a major role     for survival of cardiac arrest patients. According to 2015 American heart association (AHA)     guideline, rescuers provide high quality CPR to adult cardiac arrest patients including 5 to     6 cm depth and 100 to 120 beat per minute rate chest compression.      However, in CPR situation, chest compression depth and rate vary according to provider's     muscle strength. In other words, the individual difference of the degree of physical activity     will make the different result for CPR. So, the investigators hypothesize that the core     muscles activation using physical fitness improves the quality of chest compression and the     quality of CPR, eventually.   "
38625|NCT02780037|"     This study examines the short- and long-term-effects of different repeated frames in which an     exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e.,     autonomous/controlled) in older people (65+). The frames are manipulated experimentally as     either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain     better health) or neutral (control condition).   "
38626|NCT02780024|"     Glioblastoma Multiforme is one of the most common, and unfortunately one of the most     aggressive brain tumors in adults with most of the patients recurring and dying of the     disease with a median survival of 16 months from diagnosis.      Current treatment for patients with newly diagnosed Glioblastoma Multiforme (GBM) is safe     maximal surgical resection followed by concomitant conventional Radiotherapy (RT) delivered     in 6 weeks + Temozolomide (TMZ) followed by TMZ for 6 to 12 cycles.      Recent scientific research has shown that Metformin, a common drug used to treat diabetes     mellitus, may improve the results of the treatment in patients with a variety of cancers,     such as breast, colon, and prostate cancer. Metformin is an attractive and safe medication to     be used in this group of patients because of its very low toxicity.      In our center the investigators have been using TMZ for 2 weeks prior to a short course (4     weeks) of RT which equivalent to the standard RT of 6 weeks. Temozolomide is used 2 weeks     before RT + TMZ, and this is followed by the 6 to 12 cycles of TMZ. Our results are quiet     encouraging with a median survival of 20 months, and acceptable toxicity.   "
38627|NCT02780011|"     This is an open label phase I trial designed to evaluate the maximum tolerated dose,     dose-limiting toxicities, pharmacokinetics, and activity of the combination of alsertib     (MLN8237) and brentuximab vedotin in patients with relapsed/refractory CD30-positive     lymphomas and solid malignancies. Cohorts of 3-6 patients will receive escalating or     de-escalating doses of MLN8237 based on a 3 + 3 design.   "
38628|NCT02779998|"     Acute respiratory failure is frequent during rhythmology procedure under light sedation in     high risks selected patients. Non invasive ventilation (NIV) is recommended for acute     cardiogenic pulmonary oedema and sleep apnea. The investigators will perform a monocentric,     prospective, randomized controlled trial to compare the efficacy of NIV which associated     pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP:     5 to 10 cmH2O) with standard oxygen therapy in prevention of peroperative respiratory event.     Our hypothesis is that peroperative use of NIV should reduce the incidence of apnea and     hypoxia during procedure in rhythmology under light sedation.   "
38664|NCT02779517|"     By developing an affordable mobile service robot for therapeutic activities in a health     center environment, this project addresses the issue of both the high cost and man-power     required to provide rehabilitation for stroke survivors and other patients. Our goal is to     measure users - clinician and patient - responses to a telepresence robot, VGo, that has been     modified with a humanoid torso robot, NAO, to facilitate remote communication between the     patient and clinician, and to complete supervisory exercise coaching.   "
38629|NCT02779985|"     Effects of foods or food substances on energy expenditure are of particular interest, because     of the increasing prevalence of obesity and its consequent metabolic diseases like type II     diabetes and fatty liver disease, all risk factors for the development of cardiovascular     diseases (CVDs). Recently, the Goji berry (Lycium Barbarum, wolfberry) was introduced into     the Western diet. L. Barbarum originates from Asia, where it is used to improve the health of     several organs. Although L. Barbarum is promoted as a super food with many beneficial     effects, consistent scientific evidence for these effects is lacking. In one study, it was     found that short-term intake of L. Barbarum polysaccharides - equal to 150 g of fresh berries     - increased postprandial oxygen consumption. This indicates that L. Barbarum might exert     beneficial effects on energy expenditure. Furthermore, long-term intervention trials have     shown beneficial effects of L. Barbarum on lipid and glucose metabolism in mice and type II     diabetic patients and on inflammatory status in healthy elderly. Altogether, L. Barbarum has     the potential to be used as a functional food to increase metabolic health, but detailed     information on the postprandial effects of L. Barbarum is missing. We therefore propose this     double-blinded, randomized, placebo controlled intervention trial to investigate the effect     of a single dose of L. Barbarum on postprandial energy expenditure substrate oxidation,     metabolic flexibility, lipid and glucose metabolism and inflammatory markers.   "
38630|NCT02779972|"     Aging is associated with numerous changes and adaptations in the cardiovascular system.     Vascular and ventricular wall thickness increase, whereas arterial compliance, endothelial     function, and ventricular contractility decline. The decline in cardiac function with     advancing age is typically seen in parallel to reduced physical activity, and it has been     proposed that lifelong exercise training might attenuate the effects of aging on the heart.      The cardiovascular system undergoes several age-related changes. For most healthy older     individuals, the heart generally functions well under resting conditions. Structural and     physiological changes tend to result in diminished exercise tolerance. However, increasingly     it has been shown that even some of these changes are more a result of a sedentary lifestyle     than an age-related phenomenon. Most elderly people tend to become less physically active. It     is difficult to separate changes intrinsic to the aging process from those arising as a     result of a sedentary lifestyle.   "
38631|NCT02779959|"     Headache is a common presenting complaint to the emergency department accounting for 1-2% of     patient visits. Of these headaches, approximately 90% are migraine, tension headache, or     combined presentations. The most commonly used migraine therapy in the ED is intravenous     prochlorperazine, but its administration requires close nursing observation, a bed, and the     insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form     of delivery that enables rapid achievement of therapeutic blood levels and may lead to     symptom resolution. In a randomized, controlled, prospective study,the investigators plan to     assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency     department treatment of migraine headaches.   "
38632|NCT02779946|"     Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the     metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD).     CHD is the most important manifestation of atherosclerosis, because of its immense morbidity     and mortality. Transient elastography (TE, Fibroscan®) including the currently developed     controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver     fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD.     Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk     assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be     screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical     and laboratory parameters. Patients will be stratified for the presence of CHD based on the     angiography results and correlation analysis with liver fat content will be performed. NFALD     screening will be validated in a subgroup by MR-based measurements.   "
38633|NCT02779933|"     A retrospective, observational study compiled data from all consecutively admitted patients     older than 18 years at ICU University Hospital in Olomouc in the period from 1 January 2011     to 31 December 2015 who fulfilled the criteria of HAP. The aim was to determine the severity     of the specific risk factors of early and late HAP. Risk factors were divided into factors     from the patient and from the hospitalization. Furthermore, an assessment of their     relationship to mortality.   "
38634|NCT02779920|"     Gastroparesis is a common chronic condition, disabling the limited therapeutic resources     justifying the exploration of new therapeutic possibilities.      By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy     pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of     choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle     often spastic that counteracts an effective gastric emptying.   "
38635|NCT02779907|"     This community-based cross-sectional survey will estimate the frequency and risk factors of     Chronic Suppurative Otitis Media and Hearing Impairment in Children ages 4-6 years in the     Chikwawa District. These data will be useful for service planning, disease prevention efforts     and to guide future research in this field.   "
38636|NCT02779894|"     This project develops a new form of management of subjects with suspected SAHS and different     sleep disorders by applying Information and communications technologies (ICT).   "
38637|NCT02779881|"     Epigenetic mechanisms have been implicated in the pathogenesis of food allergy. The     investigators previously demonstrated that tolerance acquisition in children with     Immunoglobulin E- (IgE) mediated cow's milk allergy (CMA) is driven by epigenetic modulation     of the Th1 and Th2 cytokine genes. A regulatory T cell (Treg) suppressive phenotype,     characterized by stable expression of the transcription factor Forkhead box Protein 3     (FoxP3), plays a pivotal role in food tolerance. FoxP3 mRNA expression is lower in children     with atopic asthma or IgE-mediated food allergy than in healthy children. FoxP3 stable     expression requires full CpG demethylation of its transcriptional regulatory regions, and,     moreover, hypermethylation of the FoxP3 gene has been associated with reduced Treg function     and allergy.      DNA methylation is a biologically and chemically stable epigenetic modification that locks in     long-term gene expression patterns. The demethylation status of FoxP3 at a highly conserved     region within the Treg-specific-demethylated-region (TSDR), a CpG-rich, located on the 2nd     conserved non-coding sequence of FoxP3 (CNS2), is restricted to Tregs. Transcriptional     activity of the TSDR is essentially determined by its methylation status : it is completely     inactive in its methylated state, but when the TSDR is demethylated, transcription factors     such as Ets-1 and Creb can bind to the TSDR. TSDR demethylated and open chromatin     conformation in the Foxp3 locus leads to stable phenotype differentiated Foxp3+ Treg. FoxP3     TSDR demethylation in peripheral blood mononuclear cells (PBMCs) has been associated with     reduced atopic sensitization and asthma in children. Epigenetic regulation of antigen-induced     T-cell subsets may predict a state of immune tolerance in food allergy. Indeed, DNA     methylation of the FoxP3 gene in Tregs decreased during oral tolerance acquisition in     patients with peanut allergy undergoing oral immunotherapy. The aim of this study was to     evaluate further the epigenetic regulation of FoxP3 gene in children with IgE-mediated CMA.   "
38638|NCT02779868|"     Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from     an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by     cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in     cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could     potentially maintain body weight in cancer patients undergoing intensive treatment.      The investigators aims in this study is to evaluate the effect of omega-3 supplementation on     body composition, functional capacity, inflammatory profile and quality of life in cervix     cancer patients undergoing chemoradiotherapy.   "
38639|NCT02779855|"     The purpose of this study is to determine if an oncolytic virus called Talimogene     laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells     while leaving normal cells alone) injected directly into the tumor during chemotherapy prior     to surgery can enhance the elimination of triple negative breast cancer tumors. The natural     herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene     laherparepvec version of the herpes virus has been changed to prevent it from reproducing in     normal tissue.      However, it can still attack and break open cancer tissue which is why it is used as a     treatment for cancer. It is thought that this virus can also help recruit the participant's     immune system to attack the cancer cells during their treatment and possibly destroy the     tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to     treat melanoma skin tumors, so investigators want to determine if this virus can achieve a     similar benefit in women with triple negative breast tumors.   "
38640|NCT02779842|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
38641|NCT02779829|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
38642|NCT02779803|"     A prospective registry evaluating the efficacy of EC-IC bypass in a subgroup of patients,     specifically, patients with carotid occlusion and symptoms refractory to medical therapy and     evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox     Challenge SPECT Scan). This subgroup includes:        1. Hospitalized unstable patient with crescendo or postural TIA's        2. Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite          medical therapy.   "
38643|NCT02779790|"     Obesity is a major risk factor for cardiovascular disease and diabetes. Weight loss is an     important therapeutic goal for overweight and obese patients to reduce their risk of     developing cardiovascular disease and diabetes. Liquid meal replacements (LMRs) are simple     tools that may aid in weight loss and may improve weight-related risk cardiometabolic risk     factors. There is a need to synthesize the evidence on LMRs and cardiometabolic risk to     inform clinical practice guidelines. The authors propose to conduct a series of systematic     review and meta-analysis of randomized controlled trials to evaluate the effect of LMRs on 4     areas of cardiometabolic risk: markers of adipsoity, glycemic control, established lipid     targets, and blood pressure.   "
38644|NCT02779777|"     This two-stage study is designed to investigate the antitumor activity of tipifarnib in     approximately 58 eligible subjects with very low, low or INT risk MDS who have no known     curative treatment. Eligible subjects may have received no more than 2 prior systemic     therapies. In the first stage, 44 eligible subjects will be enrolled and stratified in to one     of four biomarker-defined strata (11 subjects per stratum) based on subject KIR2DS2 and     KIR2DL2 positivity. Subjects will receive tipifarnib administered at a starting dose of 900     mg, orally with food, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21)     in 28 day cycles. At the discretion of the investigator, the dose of tipifarnib may be     increased to 1200 mg bid if the subject has not experienced dose limiting toxicities at the     900 mg dose level. Determination of RBC tranfusion independence and disease response will be     performed by the Investigator according to the MDS/MPN International Working Group (IWG)     criteria. Similarly, disease progression will also be determined based on the MDS/MPN IWG     criteria.   "
38645|NCT02779764|"     The objective of this study is to evaluate the efficacy and safety of ASP1517 in hemodialysis     patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating     Agent formulation .   "
38646|NCT02779751|"     The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in     combination with pembrolizumab in participants with advanced non-small cell lung cancer     (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative     (HER2-) breast cancer.   "
38647|NCT02779738|"     The purpose of this study is to evaluate the effect of food on merestinib (standard meal and     high-fat meal) compared to the fasted state. The study will also measure how much of the     study drug gets into the blood stream and how long it takes the body to get rid of it. In     addition, the tolerability of the study drug will be evaluated. Information about any side     effects that may occur will also be collected. The study will last approximately 28 days.     Screening is required within 28 days prior to the start of the study.   "
38648|NCT02779725|"     This project will determine the most important and cost effective components of     SymptomCare@Home, a new approach to cancer chemotherapy symptom care that has been shown to     reduce problematic symptoms through automated daily monitoring, self-management coaching, and     oncology team follow-up care using decisional support for patients at home when their     symptoms are most likely at their worse. Once the key parts of the intervention and its cost     effectiveness are known, it can be moved into everyday cancer care.   "
38661|NCT02779556|"     The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural     PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.      The primary aims are to:        1. test the effectiveness of the ACP diabetes health literacy intervention to improve a          range of diabetes-related outcomes among rural patients;        2. compared to usual care, evaluate whether the intervention reduces disparities by patient          literacy level.           The secondary aims are to:        3. investigate whether a threshold or gradient effect exists between the amount of          follow-up counseling (number of action plans) and intervention effectiveness;        4. determine the fidelity of all intervention components, and explore any identified          patient, provider (physician, nurse, health coach), and/or health system barriers to          implementation; and        5. assess the costs associated with implementing the intervention from a health system          perspective.   "
38769|NCT02778152|"     Pilot study to assess tolerability and safety of laser hair depilation in adolescents and     young adults with pilonidal disease.   "
38649|NCT02779712|"     Stroke has an enormous impact on both individual and society. Novel treatments are required     to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC     refers to applying non-lethal ischaemia to an area distant from an organ you are trying to     protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be     neuroprotective and help restore functional outcome when compared to control. These outcomes     are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very     soon after the stroke occurs. The mechanisms of protection are unclear but may be due     enhancing the body's ability to protect itself from further injury by favorably altering     cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic     conditioning (IC) is an intervention already applied during cardiac surgery to protect the     heart from damage and it may be effective after an acute myocardial infarction. The     investigators therefore plan to conduct a pilot randomised controlled trial assessing the     feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in     patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC.     Secondary outcomes include tolerability, safety and clinical efficacy. The results will     inform the design of future trials of a potential intervention is that is pragmatic,     non-invasive and simple to administer.   "
38650|NCT02779699|"     To study the pharmacokinetic characteristics of AL2846 in the human body, recommend a     reasonable regimen for subsequent research.   "
38651|NCT02779686|"     This study is being conducted to compare two different genetic tests developed to determine     an individuals risk of developing serious vision threatening complications from age-related     macular degeneration (ARMD).   "
38652|NCT02779673|"     The purpose of randomized, double-blind, placebo-controlled study was to determine whether     yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the     control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.   "
38653|NCT02779660|"     The aim of the study is to examine the effect of RIPC on physiological parameters in     non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique     bio-date base for further analysis of molecular and genetic mechanisms responsible for     observed results.      The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be     implemented as additional treatment component to reduce AF burden and minimize thromboembolic     risk.      Interim Analysis will be done after 73 patients.   "
38654|NCT02779647|"     Introduction Overweight and obesity are characterised by excess fat, which results in weight     gain and is identified by the Body Mass Index (BMI). Studies show that overweight and obesity     are the result of a complex interaction between genetic and environmental factors, which     begins prenatally. Various studies have shown that physical exercise is an important     component of weight loss programmes and that it also benefits the metabolic profile. Other     authors have reported that greater weight loss is achieved by a programme that includes both     diet and exercise, rather than either of these alone.      Aim The aim of this study is to analyse an intervention based on play as a means of improving     the body composition of children with overweight or obesity.      Design / Method The design of the Kids-Play study is based on cases and controls. The study     was conducted in Granada (Spain) from October 2014 to June 2015. The analysis sample of 54     children was divided into two groups: cases, consisting of 27 children, who participated in     an intervention programme based on physical activity, play and nutritional advice (to both     the child and the parents); and controls, another 27 children, who received only nutritional     advice.   "
38655|NCT02779634|"     There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on     echocardiographic indices of diastolic function in elderly patients with heart failure with     preserved ejection fraction (HFPEF). In previous studies the only echocardiographic     parameters studied were ejection fraction (EF) and chamber size. The objective of the     proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic     function assessed by echocardiography in patients over the age of 50 with a clinical     diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for     this study as it has been shown to have superior bioavailability when compared to oxidized     CoQ.   "
38656|NCT02779621|"     To explore the potential for vaginal self-sampling to increase participation in cervical     screening, we offer the option of self-sampling to a group of non-participants in cervical     screening (intervention), in addition to the routine screening (smear) test. Women in the     control group will only receive the routine screening invitation letter. The total screening     uptake rate, 2 months since the recruitment in each group will be compared.   "
38657|NCT02779608|"     This is a clinical Study to evaluate the effect, survival benefit and safety of     intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant     ascites.   "
38658|NCT02779595|"     Perioperative changes in regional ventilation by pulmonary electrical impedance tomography     and spirometry will be investigated in patients at risk for postoperative pulmonary     complications. Those patients undergo lung and flail chest surgery.   "
38659|NCT02779582|"     This study is designed to evaluate the within-woman effect of oral micronized progesterone     (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup®     (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of     soaked normal-sized sanitary products such as normal-sized tampons or pads as well as length     of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women with hot     flushes and night sweats who are qualified to enroll in the primary perimenopausal hot flush     trial stratified by whether they are in Early or Late Perimenopause.   "
38660|NCT02779569|"     To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS   "
38662|NCT02779543|"     This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone     UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is     considered the gold standard for sleep assessment. This research is being done because if     proven to accurately analyze sleep,these devices may make conducting in-home sleep studies     easier and more affordable in the future.   "
38770|NCT02778139|"     The aims of this study were: (1) to examine the risk behaviours, lifestyle and its associated     psychosocial factors for youth smokers; and (2) to explore the relationships among     self-esteem, depressive symptoms and quality of life in youth smokers.   "
38665|NCT02779504|"     The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of     the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk     of post surgical infections after orthopaedic endoprosthetic replacement surgery.      This Post Market Clinical Follow up study is designed to retrospectively establish the     infection rate of a cohort patients who have received an Agluna® Treated METS implant and     compare the clinical data to patients that have received an untreated METS implant; in order     to provide evidence to support the investigators' clinical claims.   "
38666|NCT02779491|"     This is a randomized controlled trial to assess the impact of a novel fruit and vegetable     mobile phone application on fruit and vegetable intakes, knowledge and attitudes.   "
38667|NCT02779478|"     A biomarker cohort study design is proposed to study whether specific airway microbiota     alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a     cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will     evaluate the airway microbiome using an aliquot of the induced sputum and upper airway     samples. Since induced sputum may reflect different regions of the upper/lower airways, the     investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control     group) of patients using samples obtained through upper airway sampling and bronchoscopy,     respectively.   "
38668|NCT02779465|"     The purpose of this study is to determine whether vitamin D is effective in the prevention of     hepatocellular carcinoma in those patients with chronic hepatitis B.   "
38669|NCT02779452|"     The purpose of this study is to evaluate the feasibility of using a quantitative EEG method     to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental     deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM)     compared to control newborns.      The second purpose of this study is to determine whether cord blood concentration in     docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled     mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to evaluate     whether this contributes to neonates neurodevelopment status.   "
38670|NCT02779439|"     To assess the safety and biological efficacy of therapeutically administered most closely     HLA-matched third party donor-derived specific cytotoxic T lymphocytes (CTLs) targeting     cytomegalovirus (CMV) or Adenovirus (Adv) or Epstein Barr virus (EBV) or fungi including     Aspergillus and Candida species for the treatment of viral infection following allogeneic     blood or marrow stem cell or solid organ transplantation.   "
38671|NCT02779426|"     The purpose of this study is to determine if sending text messages with treatment reminders     and facts regarding atopic dermatitis (AD) to caretakers of children with AD will have a     positive effect on the disease severity.   "
38672|NCT02779413|"     This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness     in patients of all age groups excluding less than 12 month old infants with diabetes mellitus     in routine clinical practice in Korea.   "
38673|NCT02779400|"     The purpose of this study is to assess the measurement conformity of an in vitro diagnostic     device measuring the INR (International harmonized Ratio).   "
38674|NCT02779387|"     This study is a multicenter, randomized-control-trial. This study select 1184 Infertile     patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going     to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a.     Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted     reproductive treatment rate, miscarriage rate, live birth rate will be recorded.   "
38675|NCT02779374|"     Currently, There is no treatment for Premature ovarian insufficiency (POI). Very small     embryonic-like stem cells (VSELs) are found in the ovary. VSELs are able to regenerate the     affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is     supposed to secrete trophic factors.      Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in     resuming the ovarian function after chemotherapy-induced ovarian insufficiency.      Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes.     Several small studies examined the use of autologous BMT both in animal and in human. The     results of these studies were promising. Intravenous injection is simpler and less invasive     than ovarian injection as the later involves the use of laparoscopy. However, intravenous     injection has not tested until now.   "
38676|NCT02779361|"     Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid     profile after green tea consumption.   "
38677|NCT02779348|"     The purpose of this study is to determine whether multiple-dose administration of nebicapone     affects the pharmacokinetics of warfarin.   "
38678|NCT02779335|"     The purpose of this prospective study seeks to assess ability to achieve enteral feeding     goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.   "
38679|NCT02779322|"     This study try to identify differences in cost, length of operation and results between two     different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the     Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish     public health system hospital.      The patients of the trial will have the preoperative studies, hospital treatment during the     admission, postoperative treatment and follow up as any other patient included in the     hospital bariatric surgery program. No new methods are applied other than randomly choose the     surgical technique.      Patients will be randomized in a 1:1 ratio to each group.   "
38680|NCT02779309|"     To develop a mortality risk prediction model that can be applied to the wide spectrum of     risks that are seen in the home care setting.   "
38695|NCT02779114|"     This is a phase 3, multicenter, randomized, open, prospective, controlled, parallel-group     intervention study in 318 patients with Rheumatoid Arthritis. The study is composed of 3     phases: a pre-randomization phase for up to 10 days followed by a 1-year randomized, open     three arm treatment phase for each patient, followed by a 5-year observational phase for all     patients still in remission.   "
38696|NCT02779101|"     In summary, there is a high medical need for patients suffering from recurrent/progressive     PCNSL. Targeting the PD-1 pathway may represent a very promising novel approach for the     treatment of these patients.   "
38681|NCT02779296|"     Surgical Site Infections (SSI) represents a significant complication in plastic surgery.     Infections can result in a prolonged recovery and impair long-term cosmetic appearance. One     potential method to reduce infection is by applying a thin layer of dermal glue over the     sutures at the site of incision immediately after the surgery. Conventional closures, such as     sutures or staples, leave the site vulnerable until epithelialization occurs in 24 to 48     hours. In contrast, dermal glue provides an instant, waterproof barrier and it has been shown     to have intrinsic bacteriostatic properties. The glue is supplied as a liquid enclosed in a     vial and when applied, polymerizes rapidly in an exothermic reaction in the presence of     moisture to form a solid adhesive. 2-Octylcyanoacrylate (2-OCA)-based glue is formulated to     be more flexible than previous preparations. The application of dermal glue is rapid, simple     and requires no specific follow-up as it naturally sloughs off overtime. The purpose of this     study is to determine if 2-OCA-based glue can reduce the rate of surgical site infection     following surgery. Patients undergoing breast surgery will be recruited and randomized to     either a group receiving a layer of glue over sutures following surgery or no treatment.     Patients will be followed up at 30 days and at 8 months for signs of infection, additional     complications and the visual appearance of the scars. The cost of treating and infection will     be calculated to determine if using dermal glue to prevent infection is economically     feasible. This research has the potential to find a method to reduce surgical site infection,     which can be applied to other surgeries.   "
38682|NCT02779283|"     This phase IB trial studies the feasibility of using a functional laboratory based study to     determine how well the test can be used to select personalized kinase inhibitor therapy in     combination with standard chemotherapy in treating patients with newly diagnosed acute     myeloid leukemia (AML). It also evaluates safety and potential efficacy. Kinase inhibitor is     a type of substance that blocks an enzyme called a kinase. Human cells have many different     kinase enzymes, and they help control important cell functions. Certain kinases are more     active in some types of cancer cells and blocking them may help keep the cancer cells from     growing. Testing samples of blood from patients with AML in the laboratory with kinase     inhibitors may help determine which kinase inhibitor has more activity against cancer cells     and which one should be combined with standard of care chemotherapy. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving a     personalized kinase inhibitor therapy combined with standard chemotherapy may be a better     treatment for AML.   "
38683|NCT02779270|"     To assess the safety of a sunscreen product when used outdoor.   "
38684|NCT02779257|"     Pasireotide binds to somatostatin receptors sst2 and sst5, which can lead to significant     hyperglycemia. The investigators would like to administer pasireotide as a treatment for     refractory hypoglycemia in the setting of metastatic insulin-producing pancreatic     neuro-endocrine tumor.   "
38685|NCT02779244|"     The purpose of this randomized, controlled trial is to estimate the safety of early weight     bearing on post ankle surgery.      Patients who are indicated to have surgery for unstable ankle fractures by an attending     trauma physician will be consented for participation in the study. After surgery patients     will be randomized to either weight bearing as tolerated at two weeks with a cam boot or     non-weight bearing with a cam boot. Randomization will be performed by number allocation with     odd numbers in the early weight bearing group and even numbers in the non-weight bearing     group. The surgeon will be blinded to this until after the surgery. The patients will all be     placed in a short leg cast post operative and made non-weight bearing for 2 weeks until     sutures are removed which is current standard treatment. Both groups will be asked to     initiate weight bearing at two weeks post operatively by wearing a cam boot that is non     weight bearing in a cam boot, the latter being standard treatment.   "
38686|NCT02779231|"     Hypertension remains one of the most important preventable contributors to disease and death.     It is the most common risk factor for strokes and myocardial infarctions in the U.S., and is     associated with the greatest attributable risk for mortality among all modifiable risk     factors for cardiovascular events. Over 50 million people are living with hypertension in the     United States, and hypertension is one of the most common reasons for visits to a healthcare     provider. Abundant evidence from randomized controlled trials has shown benefit of     antihypertensive drug treatment in reducing important health outcomes in persons with     hypertension. Yet, approximately 20% of U.S. adults are unaware that they have the disease.      Hypertension is more difficult to diagnose than other common medical illnesses. In most     cases, hypertension is asymptomatic; and accordingly patients do not seek care for it as they     do for other common symptomatic illness. Patients are frequently diagnosed after presenting     with end organ disease (e.g., myocardial infarctions, congestive heart failure, strokes, or     renal failure). Another complicating aspect related to diagnosing uncontrolled hypertension     is that multiple blood pressure measurements are needed to establish a diagnosis. Blood     pressure readings can be falsely elevated in clinic due to the presence of an observer or the     clinical surrounding (e.g., white coat hypertension). Even if an elevated blood pressure     reading is identified in a clinic setting, more readings are needed in order to make it     possible for physicians to decide about the next appropriate medical intervention. This need     for multiple BP measurements over time often delays both initiating and modifying medical     therapy for uncontrolled hypertension.      Having patients take their BP at home facilitates the more timely diagnosis of uncontrolled     hypertension by reducing diagnostic uncertainty. In fact, home measurements are better     diagnostic indicators of stroke and cardiovascular mortality than clinic readings, are more     closely correlated with end-organ damage, and are cost effective and well-tolerated by     patients.      Patients are frequently asked to record their BP after clinic visits. Historically, patients     used a hand-written log, but more recently, patients are instructed to use an Internet-based     web portal that uploads values to the patient's electronic medical record. Compliance with     either approach relies on effective patient and provider followup, and in many settings,     nurses or pharmacists will need to call patients to prompt them for their blood pressure     measurements, which is both a costly and time consuming approach. Therefore, researchers need     to develop effective, yet low cost alternatives to monitoring home blood pressure.      This study proposes such a solution. The purpose of this study is to evaluate a simple     m-health intervention to increase the ease and efficacy of diagnosing uncontrolled     hypertension and achieve better blood pressure control in hypertensive patients.   "
38697|NCT02779088|"     This cohort study will establish the urban elderly cohort, measure both physical and     functional parameters, find the risk factors for aging, and validate the role of strength     training for those sarcopenic patients. Investigators hope this study will be widely cited in     related fields in the future.   "
38698|NCT02779075|"     The overall aim of the application is to determine the contribution of the elevated incretin     hormone concentrations seen after certain types of bariatric surgery to the regulation of     food intake and satiety.   "
38711|NCT02778906|"     This is a randomised double-blinded placebo-controlled multi centre study in 98 patients with     ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at     baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6     months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the     follow up period for another 12 months up to month 18. Patients developing arthritis will be     treated according to local guidelines.   "
38687|NCT02779218|"     Strokes represent, in industrialized countries the leading cause of acquired motor disability     in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases     of hemiplegia each year. These patients will see their deficit to improve during the first 6     months after stroke. This recovery is largely based on brain plasticity mechanisms and the     rehabilitation has as main objective to optimize these mechanisms. However, only 20% of     patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack     of functionality is not only due to overall strength gap but also to the predominance of this     gap on the extension movements of the wrist and fingers.      Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain     stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations     (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In     previous studies, the investigators have shown over a 30 minutes session lasting facilitation     (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR).     Several studies showed an adjuvant effect when GSIN were associated with learning of a motor     task. For PAS, some studies have shown a greater facilitation when the latter is associated     with muscle contraction.      The motor imagery (MI) is imagining a movement without realizing it, it is based on     mechanisms similar to those of the real movement. This technique also showed its effects as     an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained     after a motor drive. Its use in patients with no motor makes its uniqueness and strength.   "
38688|NCT02779205|"     The beneficial effect related to the administration of adipose tissue-derived stromal cells     (ADSC) is demonstrated in various situations of physiological and pathological wound healing,     thus opening a new field for cell therapy. Despite the use of new technologies, management of     burns in children as well as congenital malformation such as hypospadias and cleft lip and/     or cleft palate can lead to aesthetic and functional sequelae requiring multiple surgical     procedures. Cell therapy based on the administration of the ADSC seems a promising issue in     such indications, however, to date no study has been conducted with ADSC from a pediatric     population. An initial study (Protocol 0808203) allowed investigors to obtain the first     samples of adipose tissue from children and to conduct an in vitro comparative study on the     characterization and properties of the ADSC from children compared to adults. In the     continuity, this second study aims to complete knowledge on the efficacy and safety of     children ADSC cell therapy assessed in an animal model of skin wound healing developed in the     lab.   "
38689|NCT02779192|"     SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that     will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of     this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an     acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will     be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute     NIHL.   "
38690|NCT02779179|"     Although RA pathomechanisms remains incompletely understood, periodontitis and RA share     pathogenic features : genetic and environmental influences, chronic inflammatory disease,     immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical     factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram     negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading     (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for     example).      Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has     an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA     increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing     a complex pluridisciplinary treatment approach. Recent studies have reported an increased     prevalence of RA patients with periodontal disease. Others studies show that periodontal     treatment induces a significant decrease of the sedimentation rate and of the DAS28.     Periodontitis is suspected to be an independent, aggravating factor in patients with RA     (given the definition from NIH : an aggravating factor is something that makes a condition     worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is     hypothesised that treating periodontitis in RA patients showing signs of periodontitis could     result in improvement in RA disease activity. To date the role of periodontitis as an     aggravating factor in these patients remains unclear, and only RCT designs can reasonably be     used to test this causal hypothesis. There still remains some RA patients who have persistent     symptoms and frequent exacerbations despite specialist care and continuous treatment, so     results of treating aggravating factors are needed. As the majority of patients will benefit     from a systematic evaluation and treatment of aggravating factors, the periodontal treatment     strategy need to be tested.      The aim of this randomised controlled trial is to assess the effectiveness of periodontal     treatment for rheumatoid arthritis patients.      To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid     arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The     hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.   "
38691|NCT02779166|"     Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures.     It has been shown to be successful in assisting in pain control for knee arthroscopy. It has     not previously been studied in hip arthroscopy. This is a double blinded randomized     controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip     arthroscopy.   "
38692|NCT02779153|"     This is a randomized study exploring the efficacy, safety and steroid sparing ability of two     doses (40 U and 80 U) of Acthar in SLE patients with immune mediated hematologic     manifestations requiring steroid use for a minimum of 2 weeks prior to screening.   "
38693|NCT02779140|"     This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to     evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).     NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin     BoNT/B poisoning in adults. Dose cohorts A, B, and C will be randomized 2:6,     placebo:therapeutic, with a total study population of 24. The study duration is projected to     be approximately 8 months, with subject participation in cohort A being approximately 13     weeks, and subject participation in cohort B and C being approximately 17 weeks. The primary     objectives of this study are to assess the safety and tolerability of escalating doses of     NTM-1632 administered intravenously in healthy adults.   "
38694|NCT02779127|"     Endothelium is considered a real member, so it is contributing to determine the vascular     homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by     non-invasive study of the variation of gauge of the brachial artery as a result of     post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events.     Several recent studies have shown that passive smoking is correlated with endothelial     dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an     increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial     decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to     smoking in non-smoking subjects, as part of a prospective study and controlled, has never     been evaluated.   "
38699|NCT02779062|"     Infants sometimes experience sudden symptoms such as breathing irregularities or limpness     that frighten parents and prompt them to seek emergency medical care. While few of these     episodes are truly life-threatening and require hospital admission, some parents may have     been so frightened that they will resist returning home from the emergency department with     their baby even if the objective risk is extremely small. Study subjects (parents of infants     with an apparent life threatening event) will be contacted and interviewed. Investigators     want to learn whether or not study subjects would accept returning home after a brief period     of observation in the emergency department if the physician determines that it is safe to do     so.   "
38700|NCT02779049|"     1. To understand the components of PBMC in MAC-LD patients, including T cells, B cells,          nature killer cells, and monocyte.        2. To confirm the phenomenon of reduced PBMC response in MAC-LD patients        3. To study the proportion of apoptosis and PD-1 expression in T cells among MAC-LD          patients, MAC colonizers, patients with tuberculosis, and healthy controls.        4. To study the apoptosis and PD-1/PD-L1 expression in T cells/macrophage from bronchial          lavage among MAC-LD patients, MAC colonizers, patients with tuberculosis,        5. To examine the PD-1 gene polymorphism and the correlation with MAC-LD.   "
38701|NCT02779036|"     In a randomized-controlled study, the effects of a structured, progressive, task-oriented     home exercise program to optimize walking competency will be evaluated in subacute stroke     survivors.   "
38702|NCT02779023|"     This study investigates the feasibility, acceptability, and effectiveness of adding     Cognitive-Behavioral Therapy for Insomnia (CBT-I) to the standard care received at the     Integrative Cardiac Health Project (ICHP) on insomnia symptoms and severity. ICHP is an     established cardiovascular disease prevention program to reduce cardiovascular disease risk     through the adoption of lifestyle changes related to improvements in diet, stress, sleep, and     exercise. The study will be conducted among patients with insomnia who are already enrolled     in the ICHP cardiovascular risk prevention program.      This is a single-center study, prospective, randomized, controlled, interventional trial     within ICHP at the Walter Reed National Military Medical Center (WRNMMC). To conduct both     phases of the study, up to 64 total male and female patients enrolled in ICHP who meet     criteria for insomnia will be recruited. Participants who meet inclusion and exclusion     criteria for this study, and consent to participate, will be randomized to one of two     conditions: (1) ICHP, or (2) ICHP + CBT-I treatment. CBT-I treatment will consist of four     in-person appointments and two telephone appointments.   "
38703|NCT02779010|"     The investigators evaluated the impact of water, sanitation and hygiene educational     Intervention and hand washing with soap on the incidence of diarrhea among under-five     children.   "
38704|NCT02778997|"     Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these     patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the     symptoms of a SD are often unspecific and the required diagnostics are time consuming,     expensive, invasive and may involve radiation exposure. In a prospective observational study     it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of     shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and     the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns     specific for certain shunt dysfunctions.   "
38705|NCT02778984|"     A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a     tight mask thereafter mask is used to make the patient breathing before intubation. Most     tight masks are actually sold but they have never been compared in studies. The aim of this     study is to compare air leaks with standard facial mask and QuadraLite masks during     preoxygenation and induction of anesthesia.   "
38706|NCT02778971|"     The main purpose of this study is to explore the impact of an amyloid positron emission     tomography and computed tomography (PET/CT) scan on physician diagnosis and management,     including drug management and care practices, for patients with a diagnosis of cognitive     impairment. This study also intends to capture specific patient-reported outcomes related to     patient burden, confidence and satisfaction.      The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain     etiology for their dementia will benefit from knowledge of amyloid plaque burden status,     through an alteration of patient diagnosis and management, which will lead to significant     changes in patient and care partner reported outcomes.   "
38707|NCT02778958|"     The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv     paracetamol during bariatric surgery.   "
38708|NCT02778945|"     In the present study, the investigators compare intermediate and deep NMB i.e. the two     extreme regimes of muscle paralysis (neuromuscular block; NMB), (I) patients receiving     intermediate muscle paralysis (''control, conventional NMB'') versus (II) patients with a     deep neuromuscular blockade with rocuronium (''Deep NMB''), will be compared during a     surgical procedure which is considered to be very sensitive for inadequate muscle relaxation,     elective minimally invasive spinal surgery.      The primary objective of this trial is to compare the operation time reduction with the help     of the decreased stiffness of targeted back muscle surrounding the surgical field.      The changed back muscle stiffness also measured as secondary objective goal by a mechanical     tension weighing scale and also taking ultrasonography using shear wave elastography (SWE).      Other observational objectives are divided into the following categories of stakeholders:     patients, surgeons and anesthesiologists', done by collecting the variety of clinical     parameters. The following will be collected and compared.        1. For patients Intraoperative radiation amount, post-anesthetic care unit(PACU) stay,          transfer rate to SICU for post-op. care, post-operative respiratory complication rate,          and total hospital costs.        2. For surgeons Post-operative complications in regard to operation field, and evaluate          surgical conditions using a Visual Analogue Scale(VAS score) in surgeon's side.        3. For anesthesiologists Intraoperative ventilation parameters of patients, and evaluate          surgical conditions using a Visual Analogue Scale(VAS score) in anesthesiologist's side.   "
38709|NCT02778932|"     Pars plana vitrectomy is usually performed under general anesthesia including endotracheal     intubation and muscle relaxation. However, for short procedures anesthesia using a laryngeal     mask without muscle relaxation is also common in practice. In this observational study the     incidence of patient movement will be examined between these anesthesia techniques.   "
38716|NCT02778841|"     Falling of the elderly as one of the greatest issues and major health problems among the     elderly population has produced a further discussion among gerontologists and physical     therapists. Moreover, they are considered as one of the major health problems among the aging     population and by now around a third of 65-year-old adults fall as a minimum once a year     while 6% of such falls cause fractures. Loss of the balance is the main reason for falling     among the elderly. Proprioception is the sensory feedback regarding the joint position sense     and movement which can accordingly lead to a decrease in the postural stability and     steadiness of the elderly people. Proprioception has shown to be a risk factor for falls in     older people. proprioception can be modified by physical training. Recently, exergaming, the     playing of video games with body movements, has been proposed as effective strategy to     deliver exercise.      Aim of study: the current research investigates the effect of 8 weeks videogame game     exercise, conventional balance exercise, and a combined of the two (mixed training) on knee     proprioception, static balance, and mobility of elderly male. Methodology: The study was     designed as a single-blinded, randomized, controlled intervention trial. Sixty-four male ages     65 years and above were randomly assigned into an exergame group, a traditional balance     exercise group, a mixed training group or a passive control group. After pretest all     participant perform 8 weeks of exercise and measured the effects of the training regimens on     proprioception and other functional outcomes as well as mood states in healthy older adults.   "
38717|NCT02778828|"     Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of 600     mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true that     if a dosage is consensus, it goes without saying, because of the interindividual variability,     marked moreover to linezolid, a therapeutic monitoring assay of plasma levels is     indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM)     often gives rise, as known, to dosage changes. It turns out that at present no real STP on     the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB)     and the bibliography remains rather poor recommendations, and yet all the elements are there:     indeed linezolid is an antibiotic whose activity is purely time-dependent. So one should     fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be determined:      -% T> MIC, or percentage of time spent with plasma concentrations above the minimum     inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the     residual concentration before the next shot must be> MIC (0.125 to 1 mg / l)        -  A fortiori it must also take into account the concentration preventing the appearance of          resistant mutants, amounting to 1.2 mg / l        -  AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma          concentration versus time and CMI LNZ Until then, and without real bibliographic          support, and for the sake of kindness to patients coupled with an economic advantage,          the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before          taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and          75% for the residual).      Following an observation that 25 to 30% of patients had a C min <1.2 mg / L, and even     frequently <0.2 mg / L to 600 mg x 1, with some low peaks and leaving presage an AUC may be     insufficient well.      This study is therefore more imperative to be a pharmacological streamlining and ensuring     adequate therapeutic monitoring involves both maximum and minimum toxicity efficiency. And in     the light of what has already been practiced for other molecules such as mycophenolate for     example which is carried AUC or miniAUC for example. It would therefore be in the achievement     of AUC in all patients treated with LNZ for TB MDR / XDR for over a week. Achieving this     requires AUC obtaining 7 blood samples given day instead of two samples taken at present.     Indeed one must have in mind that the peak of rational / residual has become blurred in this     context, and that one of the two goals PK / PD is now filled (Cmin> MIC / CMP) but it should     not be that not at the expense of the second (AUC). The benefits, direct and indirect are     multiple and obtaining them is ensured through this protocol. The study by analyzing     individual data will confirm the accuracy of the dose fractionation 300mgx2 / day and at a     time to highlight a potential new dosage adjustment that would need to achieve for further     study, so a substantial gain in terms of efficacy and toxicity via a suitable therapeutic     monitoring. Secondly, determine which collection points, in these patients, these doses will     be most interesting to take later in the routine of STP in order to collect less points (eg     miniAUC MPA) retaining same statistical power to estimate kinetic parameters, mainly the AUC     (eg aminoglycoside also). Finally in a third phase construction on the basis of these     individual kinetics of a population pharmacokinetic model with highlighting of population     parameters and especially co-related variables explaining the high pharmacokinetic     variability and allowing for following patients to determine the individually tailored dose     immediately before the first shot and the first assays.   "
38718|NCT02778815|"     This study examines the relationship between self-compassion and wellbeing in new mothers and     whether an online self-help course for new mothers can help to improve their wellbeing and     self-compassion.   "
38719|NCT02778802|"     This study is designed as a prospective study, with the primary endpoint being changes in     pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.      Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.   "
38720|NCT02778789|"     Comparing the structural effects of TNFi and tocilizumab on the periarticular bone by     performing a comprehensive analysis of the periarticular bone changes in RA patients treated     with either TNFi or tocilizumab in a longitudinal Setting, using high-resolution peripheral     quantitative computed tomography (HR-pQCT), a very sensitive method for visualizing and     quantifying bone microstructure in RA patients. Quantitatively assessing the changes of     erosions volume, osteophytes size and the area of cortical fenestration in a group of     TNFi-treated and a group of tocilizumab- treated RA patients.   "
38721|NCT02778776|"     Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid     metabolism, especially triglyceride and hypertension are metabolic disorders that play a     central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular     morbidity and mortality associated with atherosclerosis, such as myocardial infarction,     cerebral vascular events, vascular dementia, heart failure and end stage renal disease.     Recently other complications related with hyperinsulinemia like the prostate benign     hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome,     given its low cost and comparable pharmacological effects to the tiazolinedionas (eg     pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty     acids and triglycerides, also it produces moderate weight loss, improving the metabolic     profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes     mellitus in individuals with impaired fasting glucose.      A second option for risk reduction would be the addition of inulin fiber type as it has been     demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.      It is expected that combination of metformin with inulin produce a beneficial effect through     farmacological synergism and the impact on fisiopatological changes of metabolic syndrome     that potentially is considered as an important risk factor for prostate growth.   "
38722|NCT02778763|"     Double blind, randomized, placebo-controlled, multicenter pilot study on efficacy and safety     of CBLB612 following single administration for neutropenia prophylaxis in breast cancer     patients receiving doxorubicin and cyclophosphamide myelosuppressive chemotherapy   "
38723|NCT02778750|"     Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic     Fibrosis patients to explore microbiome features that are associated with an inflammatory     phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome     are associated with host inflammatory responses.      While chronic and polymicrobial airway colonization are commonly recognized in cystic     fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with     pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic     Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway     microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be     three approaches to understanding inflammatory responses; 1) a longitudinal assessment of     temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison     of the regional differences in airway microbiome between lung segments with more versus less     disease; 3) evaluation of functional aspects of the lung microbiome.   "
38734|NCT02778607|"     Progressive Supranuclear Palsy (PSP), Cortico-Basal Degeneration (CBD) and Multiple System     Atrophy (MSA) are degenerative brain conditions for which there are currently no curative     treatments. To aid the development of new treatment trials, there is a pressing need to     develop better methods for diagnosing these conditions early, and to track disease     progression. The PROSPECT-M-UK study will collect standardised clinical data over time.     Patients will also have the option to have a brain MRI scan, eye movement exam and donate     blood, skin and spinal fluid samples, with the aim to identify biomarkers that can improve     the accuracy of early diagnosis and track the natural time course of disease. Control     participants and those not meeting criteria for Parkinson's disease or other defined     conditions but are considered by the investigator group to be allied syndromes or at risk     states (atypical parkinsonian syndromes), will also be examined. Patients can also     participate via the CBD European registry or in a one-off study assessment through the     cross-sectional study, which involves completing questionnaires and a blood sample donation.   "
38735|NCT02778594|"     The purpose of this study is to determine the effect of three single oral doses of nebicapone     (50 mg, 100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination     with a single-dose of controlled release levodopa 100 mg/benserazide 25 mg (Madopar® HBS     125).   "
38724|NCT02778737|"     Chronic pain is a long-term condition which is related to a number of negative consequences     including reduced productivity at work, increased number of sick leave , depression and     emotional difficulties among others. Psychological interventions, particular Cognitive     Behavioral therapies (CBT) are deemed effective in reducing the negative consequences     following a diagnosis of a chronic pain condition. Though research provides substantial     evidence for the CBT effectiveness, not all patients manage to reduce pain intensity or     improve their physical and psychosocial functioning. Also, CBT appears with only small effect     sizes on variables considered to be core domains in chronic pain. Finally, there are     criticism targets on the lack of clear mechanisms underlying the process of change in CBT.      New CBT therapeutic approaches, such as Acceptance and Commitment Therapy (ACT) focus on     changing individuals' relation with their inner experiences. They utilize mindfulness and     acceptance processes, instead of directly changing or controlling the content of internal     experiences, as CBT does. ACT has received support for its effectiveness in chronic pain but     there are very few clinical randomized trials to compare it with traditional CBT.      The purpose of this study is to determine whether an ACT-based intervention when compared     with a CBT-based intervention designed for chronic pain patients is efficacious in reducing     pain interference, pain-related disability, and psychological distress. Also this study aims     to examine whether any therapeutic effects result due to the effect of acceptance, for those     participating in the ACT group or control appraisal, for those participating in the CBT     group. Better knowledge of the mechanism of therapeutic change can help us to recognize which     patients can be benefit from which approach.   "
38725|NCT02778724|"     Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis     in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully     integrated to usual coronary activity report software, started in Centre Val de Loire (CVL)     region in 2014.      CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is     regularly evaluated and allowed building an exhaustive, and reliable database. This solution     could easily be developed in other French regions.   "
38726|NCT02778711|"     The purpose of this study is to assess the efficacy of anti-IL 17 treatment (secukinumab) in     patients with known severe allergic contact dermatitis (ACD).   "
38727|NCT02778698|"     This expanded access protocol is for children that cannot get enough nutrients from food and     must receive nutrition through a vein. The standard nutrition given through a vein is blend     that has soybean fat. If this is given over a long period of time, it can cause problems. It     can lead to severe and/or permanent injury to the liver.      It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the     soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.      Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under     an expanded access protocol as an alternative to the soybean fat blend.   "
38728|NCT02778685|"     This phase II trial studies how well pembrolizumab works when given together with letrozole     and palbociclib in postmenopausal patients with newly diagnosed stage IV estrogen receptor     positive breast cancer with stable disease that has not responded to letrozole and     palbociclib. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of     tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells.     Antihormone therapy, such as letrozole, may lessen the amount of estrogen made by the body.     Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Giving pembrolizumab, letrozole, and palbociclib may be an effective treatment     for patients with stage IV estrogen receptor positive breast cancer.   "
38729|NCT02778672|"     This is a study of up to 250 participants from birth to 12 months who are having a chest     x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi.     Participants will have thermal pictures of their chest taken by trained study staff using a     Smartphone and a FLIR ONE attachment. Thermal images will be read by trained study staff to     determine if bacterial pneumonia is present. Results of the thermal images will then be     compared to the results of the chest X-ray. If additional images of the chest are available,     additional thermal images will be taken of the same location within 24 hours of the other     image.   "
38730|NCT02778659|"     This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep,     cognitive and motor performances and on acute mountain sickness symptoms at high altitude.     Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high     altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms,     cognitive and motor performances will be assessed to determine potential residual effects of     Zolpidem within such conditions.   "
38731|NCT02778646|"     Familial hypercholesterolaemia (FH) is an autosomal dominant somatic mutation commonly     located on the LDL-receptor, APOB, and PCKS9 gene. The estimated prevalence of homozygous FH     is estimated at 1 in a million, whereas the prevalence of heterozygous FH ranges from     1/500-1/200 (0.2-0.5%) of the general population. The majority of individuals suffering from     FH remain undiagnosed and without treatment. Using preexisting clinical guidelines, this     study scored patients within national cardiovascular disease (CVD) registries for FH with the     aim of evaluating prevalence of FH among individuals suffering from premature cardiac events     within the UK.      Following scoring of the registry, this study also examined the relationship between     cholesterol and survival after a premature event in order to understand the possible     ramifications of untreated FH on patient survival.   "
38732|NCT02778633|"     The purpose of this study is to determine fluid responsiveness in critically ill patients by     measuring mean systemic filling pressure on the intensive care unit.   "
38733|NCT02778620|"     The purpose of this study is to determine fluid responsiveness in critically ill patients by     measuring mean systemic filling pressure on the intensive care unit.   "
38736|NCT02778581|"     The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a     composition related to short, medium and long unsaturated chain fatty acids on patients with     a diagnose of cognitive impairment or mild to moderate Alzheimer disease   "
38737|NCT02778568|"     The aim of this study was to analyze the effects of resistance exercise and training on     cardiovascular function of peripheral artery disease patients.   "
38738|NCT02778555|"     This study sought to develop and validate a brief, daily version of the Pain Catastrophizing     Scale.   "
38739|NCT02778542|"     The goal of this pilot study is to test different approaches to monitor medication adherence     in hypertension patients, leveraging the NIH-funded Way to Health platform. Patients with     poor blood pressure control will be recruited from the University of Pennsylvania Health     System practices and offered remote monitoring with electronic pill bottles, bidirectional     text messaging or usual care. Our aim is to analyze and compare the effects of remote     monitoring with electronic pill bottles versus bidirectional messaging on blood pressure     reduction after 4 months.   "
38740|NCT02778529|"     This study is being performed to assess how certain chronic disabilities - stroke, upper     extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from     healthy subjects in their ability to perform ADLs. By studying the kinematics of the     respective cohort of study participants as they are assessed performing common activities of     daily living (ADLS), the investigators research team aims to better understand how impaired     neural pathways, and pathways that have been impaired at various points along the pathway,     deleteriously affect ADLs in patients with differing long-term disabilities.   "
38741|NCT02778516|"     Dietary sodium intake independently increases the risk of mortality in end stage renal     disease (ESRD). It plays a significant role in hypertension, hypervolemia, and left     ventricular hypertrophy (LVH), and blunts the effectiveness of hypertensive agents. In     addition, the hypervolemia associated with excessive dietary sodium intake results in the     need for more intense fluid removal during dialysis (ultrafiltration), resulting in symptoms     such as pain, cramps, hypotension, nausea, and vomiting during hemodialysis (HD) treatment     sessions. Although sodium restriction is a universal recommendation for ESRD management, the     National Kidney Foundation (NKF) recommendation of 2400 mg/day is consensus-based per the     Dietary Approaches to Stop Hypertension (DASH) studies, not an evidence-based recommendation     from data derived from a dialysis population. In addition, The Dietary Guidelines for     Americans 2010, recommend further restriction of dietary sodium intake to 1500 mg per day for     persons with hypertension and/or kidney disease, middle-aged and older adults, and African     Americans, though there is also little empiric evidence to support this recommendation in the     general population and none in the dialysis population. Therefore, it remains to be     demonstrated that a diet with such sodium restrictions is attainable, sustainable, safe or     beneficial. The investigators propose a double blind randomized controlled design     investigation to examine the feasibility of assessing the effects of three levels of sodium     intake (ambient, 2400 mg/d, 1500 mg/d) on the hemodialysis (HD) participant symptom profile,     and to compare the effect of hemodialysis-specific variables on participant symptom profile     during dialysis as well as to explore the role of body fluid composition using bioimpedance     (BIA) measurements among the three sodium-restricted groups as a marker of sodium restriction     efficacy.   "
38742|NCT02778503|"     Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental     caries, applying the partial caries tissue removal philosophy using hand instruments,     relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and     avoiding local anesthesia. The chosen material for this study will be the High Viscosity     Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its     applicability in challenging clinical situations where other materials would not be adequate.     Although there are substantial evidences regarding GIC properties, information about GIC     (with different costs) longevity is still weak. Therefore, the objective of this study is to     assess the effectiveness of ART restorations performed with low-cost HVGIC in cavitated     dentine carious lesions in primary and permanent molars. This will be a multicenter     randomized controlled double-blind (patient and operator) clinical trial performed with 680     primary and/or permanent molars in children between 4 and 9 years old presenting cavitated     dentine carious lesions in occlusal and occlusal-proximal surfaces. The tooth will be     considered as the unit sample, which will be randomly allocated to the groups through a     generated random list numbers and distributed in dark sealed envelopes opened only by dental     assistants. Teeth in the test group will be submitted to restorative treatment with HVGIC     Vitro Molar and those in the control group with HVGIC Fuji IX. The restoration effectiveness     will be assessed by means of both clinical and bitewing x-rays control after 6 and 12 months.   "
38743|NCT02778490|"     In this pre-post observational study, the investigators will enroll and follow a cohort of     about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and at     6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic and     imaging techniques to evaluate calcium metabolism and skeletal health. Specific outcomes     include intestinal calcium absorption capacity, bone mineral density (BMD) assessed by     dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), and bone     structure assessed by QCT and high-resolution peripheral QCT (HR-pQCT).   "
38744|NCT02778477|"     The current study is the first clinical trial proposed with PF-06423264. It is designed to     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of     multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.   "
38745|NCT02778464|"     When women with rheumatoid arthritis become pregnant 75% of them will go into remission,     despite stopping medication. This phenomenon is not well understood and is not seen in other     inflammatory conditions. Once they give birth they often relapse. Bacteria in the stool and     inside the gut have the ability to effect the immune system and some beneficial bacteria are     known to down regulate inflammatory components of the immune system. Gut bacteria are also     known to alter significantly during pregnancy and in other inflammatory conditions there are     low levels of beneficial bacteria associated with diseases like ulcerative colitis. There is     significant crossover between rheumatoid arthritis and inflammatory bowel disease with     similar arthritic symptoms and mechanisms of inflammation. There is very limited     investigation of gut bacteria and rheumatoid arthritis, but some animal work has shown that     treatment with probiotics and prebiotics can improve the condition. The aim of this study is     to examine the bacteria in the stool of women who are pregnant with rheumatoid arthritis and     identify any significant bacteria changes that might be used to direct future research.   "
38746|NCT02778451|"     Ultrasonography (US) is an operator depended image modality that is difficult to reproduce     and interpret by others. Competence of the US operator is crucial for reliable diagnostics     but no evidence-based certification of head and neck US skills has been developed.     Investigators conducted an experimental study aimed to explore diagnostic accuracy and     establish validity evidence for certification standards in surgeon-performed ultrasonography.   "
38747|NCT02778438|"     REINVENT is a non-interventional, multi-center, research network-based cross-over study     evaluating the potential utility of a telehealth platform in improving the efficiency of     clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated     through a single main study site. Potential subjects will be screened and randomized (1:1) at     Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures     are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an     in-person visit.   "
38749|NCT02778412|"     When the DNA inside of human cells undergoes certain alterations (mutations), the cells may     develop into a cancer. The cancer cells may shed this DNA into the blood stream. This     circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory     tests. Measurement of ctDNA has been shown to be useful for following patients with known     cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in     individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy     of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test     can detect a cancer at a very early stage. The results of this study should help define the     role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it     is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how     often is ctDNA found in patients with benign thyroid nodules).   "
38750|NCT02778399|"     The primary objective of this study is to assess the efficacy and safety of a range of oral     doses of OBE2109 versus placebo, in reducing endometriosis associated pain.   "
38751|NCT02778386|"     This Phase I evaluation of N-MCT in normal volunteers requires sequentially increased doses.     At each dose level, the safety and pharmacokinetic will be measured. This Phase I trial will     have the dose range of N-MCT from 200mg - 1200mg per patient.   "
38752|NCT02778373|"     This study sought to examine differences in resistance exercise performance, as measured by     the kinetic and kinematic profile during multiple sets of the back squat exercise, following     ingestion of high or low molecular weight carbohydrate beverages.   "
38753|NCT02778360|"     The main objective of the study is to demonstrate the non-inferiority of the personalized     Neurofeedback Training device versus Methylphenidate in the treatment of children and     adolescents with Attention-Deficit/Hyperactivity Disorder.   "
38754|NCT02778347|"     The purpose of this study is to develop and validate a comprehensive and standardised tool     for assessment of patient needs in palliative care.   "
38755|NCT02778334|"     Introduction and literature review With 130 000 cases per year in France in 2010, stroke is     one of the most common neurological diseases, often leaving many disabling sequelae physical     and cognitive levels (currently live 500 000 disabled following a stroke) and leading and a     loss of significant autonomy in these patients. However, many stroke survivors soon find a     range comparable to their previous state. Investigators can then ask ourselves about the     impact of this life event in these people who apparently do not show visible effects: what     about the psychological repercussions of stroke in these patients healthy; what is changed in     their daily lives, particularly in their mental functioning after this brutal confrontation     with their own mortality?      Objectives Our project aims to better understand the psychological repercussions of stroke in     patients who quickly find a health and autonomy comparable to their previous state. The     objective will be to investigate the relationship between depressive symptoms and anxiety,     coping strategies and quality of life from the acute phase and during the first months after     the onset of stroke. This period is particularly demanding for these patients must therefore     adapt and readjust continuously: shock stroke, hospitalization in several services (intensive     care, neurology, rehabilitation), back home, new life with the changes related stroke,     resumption of a professional activity, etc ...      Our methodology will combine tools conventionally used (standardized interview, validated     questionnaires) to newer, ecological and true methods (Experience Sampling Method applied by     the use of a smarphone application) to assess different variables studied.      This initially be determined whether the various symptoms of the depression on the one hand     and anxiety on the other hand, depending on their mode of expression (vs. outsourced     internalized; ie emotional, cognitive, somatic), observed from the acute phase of stroke, are     related and predict the quality of life, depression and anxiety in the longer term (four     months after the stroke).      Furthermore, our study will observe if the individual coping strategies (coping) daily and     evolution influence the psychological status and quality of life during the months following     the stroke.   "
38756|NCT02778321|"     Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of     small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However, up     to 40% of CI remains unexplained after a thorough diagnostic workup. They are called     cryptogenic IC.      Atrial fibrillation (AF) is the cause of 25% of the CI but it is recognized that episodes of     paroxysmal AF, asymptomatic and unnoticed, may be responsible for a portion of the IC     cryptogenic pace. Recognition of these episodes is of great importance since they have the     same risk embolic the FA continues [1, 2] and motivate anticoagulant therapy startup.      Several recording techniques heart rate were evaluated after the IC for detecting the AF.     Their profitability increases with the duration of the recording: about 3% for a typical     24-hour Holter, the AF detection rate increases to 6% for a 7-day surveillance period, to     12-23% for 30 days and 17-26% with implantable recorders long.      Otherwise brief rhythmic heart abnormalities can be detected with the waning of an CI without     the significance of these episodes is known.      Investigators decided to conduct this study because there is no prospective study of good     quality with a sufficient number of patients that evaluated the interest of a non-invasive     recording of long duration. The only randomized CRYSTAL AF is used for invasive subcutaneous     implantable monitor (Reveal XT).      To clarify the significance of arrhythmias and because the presence of several causes is     common after 65, investigators propose to record all patients hospitalized for HF.   "
38757|NCT02778308|"     Carcinoma of the gallbladder is the commonest malignancy of the biliary tract. Higher     incidence has been noted in Chile, Mexico and Southwest American Indians.[1] It is the third     most common malignancy in India.[2] The disease may mimic benign disease in presentation.Up     to 1/3rd of patients may present with jaundice but of these only 7% will be resectable.[4]     With aggressive surgical resection, actuarial 5 year survival of 83% for stage II disease and     63% for stage III have been reported.[5] Treatment of choice is complete surgical resection.      The role of chemotherapy and radiotherapy is not very well documented in treatment of     gallbladder cancer. Because of the propensity of gallbladder carcinoma to spread to regional     lymph nodes at an early stage and the high rate of loco regional recurrence, adjuvant     chemotherapy or chemo-radiotherapy seems a rational therapeutic option. Gemcitabine with or     without Cisplatin has been increasingly used. In a recent paper Gemcitabine with Cisplatin     was found to be more effective than gemcitabine alone and provides definite survival     advantage and progression free survival.[6] An earlier randomized trial done to assess the     efficacy of the adjuvant chemotherapy for the pancreato-biliary cancer reported improvement     in disease free and overall 5 year survival.[7] But this study has included patients with     suboptimal resection and all pancreato-biliary malignancy.      In view of these observations this study is being designed to assess the efficacy of the     chemotherapy in the adjuvant setting in gallbladder cancer patients who have undergone     curative resections.   "
38758|NCT02778295|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of a Fabry     disease from plasma   "
38760|NCT02778269|"     Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD)     exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD).     Various studies have shown that hypoglycemic episodes are strong predictors of cardiovascular     mortality in both type 1 and type 2 diabetic patients. Experimental data and small clinical     studies link hypoglycemia with ECG changes and SCD, but little is known about the direct     association of hypoglycemic events and/or rapid swings in blood glucose with arrhythmias in     this high risk population. Ideally, an algorithm should help to identify patients at risk for     hypoglycemia-associated arrhythmias and SCD, but hitherto systematic analyses of blood     glucose values and 12-channel ECGs are lacking in these patients.      In this validation study a 12-lead ECG T-shirt consisting of textile electrodes and a data     logging device wich can record long-term 12-lead ECG data will be tested. The purpose of the     T-shirt is to improve the patient's comfort for long-term recordings and to prevent adverse     effects of regular ECG electrodes. Current systems are limited by the use of ECG electrodes     involving disadvantages like severe direct side effects on the skin such as rash and bullous     lesions as well as slipping electrodes. By the means of the proposed ECG T-shirt those     drawbacks will be avoided.   "
38761|NCT02778256|"     Vestibular stimulation has been shown to be a very effective noninvasive treatment for major     depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive     and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually     are resistant to actual available treatments. This study investigates the effectiveness of a     particular technique of vestibular stimulation in a group of 120 bipolar type I and II     patients. After randomization 60 of them will receive specific vestibular stimulation     (experimental group) and 60 will receive a sham vestibular stimulation.The study will     conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.   "
38762|NCT02778243|"     Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a     prostatectomy.        -  Patients justifying prostatectomy together with the bladder (radical cystectomy for          bladder cancer).        -  Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum          sexual steroid concentrations and intra-tissue on healthy prostates and prostate          adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate          specific blood sample under study (30mL) will be performed preoperatively in Patients          followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of          prostate tissue or metastasis will be analyze.      Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy     prostates and prostate adenomas compared to concentrations measured in patients operated for     prostate cancer.   "
38763|NCT02778230|"     The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber     on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota     composition and activity.   "
38764|NCT02778217|"     Culture media used to support development of zygotes to the blastocyst stage is based on two     basic philosophies: a single step medium let-the-embryo-choose or a sequential medium     back-to-nature.      For single step media, there are two types of protocol can be used for the culture of human     preimplantation embryos:        1. Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo          culture        2. Uninterrupted single embryo culture, in which the same single medium is used throughout          the 5-6 days of culture with no replenishment or replacement on Day 3.      Investigators aim to compare the blastocyst development and clinical outcome between the two     types of protocols of a single medium (with or without renewal on Day 3)   "
38765|NCT02778204|"     This study will evaluate the safety, tolerability, and pharmacokinetics of maraviroc in     infants at risk for mother-to-child HIV transmission and determine an appropriate dose of     maraviroc during the first 6 weeks of life.   "
38766|NCT02778191|"     Concomitant chemoradiotherapy improves overall survival in patients with locally advanced     head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin     100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late     toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative     but both chemotherapy regimens have not been compared prospectively. The aim of this study is     to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC     treated with concomitant cisplatin and carboplatin plus 5-FU.   "
38767|NCT02778178|"     Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are     established techniques for lumbar interbody fusion. In contrast with posterior approaches,     they allow free approach to the anterior disc space without opening of the spinal canal or     the neural foramina. However, the additional anterior approach conveys specific concerns,     including abdominal pain that may delay recovery after surgery. The transversus abdominis     plane (TAP) block is a validated approach for postoperative pain relief following abdominal     surgeries. There is currently no evidence of the possible benefits of TAP block as part of     multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a     single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery.     The main goal of this prospective, randomized, double-blind, placebo-controlled study is to     demonstrate a >35% reduction in opioid consumption during the 24h following ALIF/DLIF     surgery.   "
38768|NCT02778165|"     MyCardiacRecovery (MyCaRe) is an interactive platform that includes a standardized     educational format and interactive tracking (wound healing and activity progression using     photo capabilities and Fitbit flex accelerometer) support during the first 6 to 8 weeks post     hospital discharge. This application will help patients and family navigate their way through     the continuum of care by providing an: a) integrated link between acute care and outpatient     cardiac rehab for efficient coordination of information and reduction in duplication of     services; b) patient care and education materials designed to address salient recovery     questions; c) improved communication between the patient and care providers and, d) ensure     streamlined systematic referral to CR. This innovative strategy has the potential to     positively impact patient satisfaction, improve patient outcomes and possibly minimize     financial constraints placed on the health care system. Phase 1 (preliminary usability     testing) of prototype 1.0 is complete. Phase 2 will focus on testing MyCaRe 2.0 in a sample     of post cardiac surgery patients using a pilot randomized controlled trial (RCT) design.   "
38771|NCT02778126|"     The main purpose of this study is to evaluate the safety of the study drug known as LY2606368     in participants with advanced cancer or cancer that has spread to other parts of the body.     This study will involve a single dose of ¹⁴C radiolabelled LY2606368. This means that a     radioactive substance, carbon 14, will be incorporated into the study drug. This will provide     information about the study drug and its breakdown products and will help determine how much     passes from the blood into urine, feces and expired air. After a minimum 14-day washout     period following the [¹⁴C] LY2606368 dose, participants will be allowed to receive continued     access to LY2606368 as outpatients.   "
38772|NCT02778113|"     The main purpose of this study is to evaluate the safety and tolerability of LY900018. The     study drug will be delivered into participant's nostril (intranasally) or will be given as an     injection just under the skin (subcutaneously) once in each of four study periods. The study     will last about 23 days for each participant.   "
38773|NCT02778100|"     The main purpose of this study is to evaluate the safety of LY900018 in participants with a     common cold, some of whom will also take a nasal decongestant. The study will investigate how     the body processes LY900018 and the effect of LY900018 on the body. The study will last up to     30 days for each participant.   "
38774|NCT02778087|"     It has been suggested that augmenting repetitive task practice with the use of box (mirror)     therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an     opportunity to engage in self-directed practice outside of normally scheduled therapy     sessions. However, the dosage of BT to be used in clinical practice is unclear. In order for     practitioners to begin integrating BT into clinical practice situations more information is     needed to determine what defines a therapeutic dose. The aim of this study is to     differentiate between two dosages of self-directed BT added to treatment as usual for     decreasing arm and hand motor impairments, improving activity level, and increasing     self-directed participation after stroke. Forty-five subjects from the Stroke Rehabilitation     Unit at Helen Hayes Hospital (HHH) will be randomly assigned into three groups: treatment as     usual plus 30 minute dosage of self-directed BT 5x/week; treatment as usual plus 60 minute     dosage of self-directed BT 5x/week; treatment as usual plus 30 minutes of self-directed sham     BT 5x/week.   "
38775|NCT02778074|"     Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new     innovative and person-centred method that is promising that may be used to decrease     depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive     symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and     mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients.     Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for     many psychiatric conditions, but few studies have evaluated CBT in patients with CVD.      The purpose of this study is to evaluate the effects of the tailored I-CBT program on     reducing depressive symptoms and other patient reported outcomes in patients with     cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT     program in clinical cardiac care.      Aims of the study        -  To evaluate the effects of the tailored I-CBT depression program on depressive symptoms,          sleep, anxiety and quality of life.        -  To evaluate factors that can influence the I-CBT programs effect on depressive symptoms.        -  To gain knowledge about the I-CBT program, as perceived by patients and health care          professionals.        -  To explore facilitators and barriers to the implementation of the I-CBT program in          clinical practice from the perspectives of patients, health care professionals and          policymakers.   "
38776|NCT02778061|"     Participating investigators will locate all IUB B insertions conducted at their facility at     least 12 month prior the initiation of study data collection. The study is composed of 2     parts. Part one is collecting data out of patient's medical record which is accessible only     to the doctor. This data is mostly demographic. Part two of the study comprises a phone call     to the patients done by the doctor or by authorized site personnel. In the phone call the     study purpose will be explained to the patient and a patient consent will be required. After     the patients consent to participate, the doctor will ask the patient the questions defined in     the study protocol regarding her experience during the time since the IUB SCu300B's     insertion.      A total of 200 eligible subjects will be invited to participate in the study. Informed     Consent Form will be signed and sent to the investigator, applicable CRFs will be completed     by the investigator or authorized site personnel. The patient questionnaires will be asked on     the telephone and entered directly into the CRF by the investigator or authorized site staff     (CRF = source document). Also the physician´s questionnaire will be directly completed in the     CRF by the investigator (CRF = source document). All other clinical data will be transcribed     to the CRF from the medical patient records (patient records = source document).      There are no planned patient visits to the doctor's office for study purposes. If the patient     visits the physician´s office as part of the clinical routine, the study procedures can also     be performed directly at the site instead of telephone contacts.   "
38777|NCT02778048|"     With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary     consortium consisting of representatives ranging from clinical medicine via microelectronics     towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The     aim of this campaign includes development of implantable prototype devices acting as     artificial continence muscles using low-voltage electrically activated polymers (EAPs)     controlled by implemented pressure sensors and the patient.      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal     sphincter complex are of cardinal importance. Most of the existing data on anatomy and     physiology results is based on old studies and almost no data on biomechanical properties are     available. However, new technologies or even merging data from different examination methods     might provide new information in this field.   "
38778|NCT02778035|"     This trial will compare the efficacy of three different patterns of twice-daily rTMS in major     depression: rTMS delivered at 0 min vs. 30 min vs. 60 min intervals. The trial will include     structural and functional MRI, EEG, and behavioral measures obtained before, during, and     after treatment.   "
38779|NCT02778022|"     The purpose of this study is to evaluate the effectiveness of PriCARE in decreasing child     behavior problems and improving parenting capacity and skills at 2 primary care clinics in     Philadelphia.   "
38780|NCT02778009|"     Using FitBit activity monitors, physical activity levels will be monitored in first year     medical students. Body Composition will be measured as well.   "
38781|NCT02777996|"     ITALUNG is a RCT for the evaluation of the efficacy of lung cancer screening with low-dose     Computer Tomography (LDCT) , carried out in three screening centers in Florence, Pisa and     Pistoia districts of the Tuscany region of Italy.      3106 high risk subjects (age 55-69, smokers or ex-smokers) were recruited and randomized to     the Active arm (Baseline + 3 annually repeated LDCT screening) or to the Passive arm,     followed up in usual care (no screening reccomended ) All subjects were invited, if smokers,     to consider smoking cessation practice. Follow-up for cause specific mortality and overall     mortality and for lung cancer incidence was performed (actually at 9.3 years since     randomization) . Blood and sputum samples were stored from the Active arm in a Biobank, with     1304 subjects enrolled in the Italung Biomarker study.   "
38782|NCT02777983|"     The purpose of this project is to measure the impact of a short educational session on     outcomes for patients consulting in primary care for low back pain. Subjects will be patients     consulting to their primary care provider for a primary complaint and new episode of low back     pain. Subjects will be randomized to receiving the educational tool versus usual care     (information only without an educational component) in the clinic immediately prior to seeing     their PCP. Patients will be followed for a 6-month period, and outcome measures will be     collected and compared across both groups.   "
38783|NCT02777970|"     The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral     fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment     of moderate to severe acute pain.   "
38784|NCT02777957|"     First, the aim of the study was to evaluate the usefulness of echocardiographic parameters     for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for     lung transplantation. Second, to assess the prevalence of PH and to identify which     hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical     parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with     severe lung diseases referred for lung transplantation.   "
38785|NCT02777944|"     The aim of this study is to test whether MotivATE can increase attendance at assessment. This     will be done using a single-consent Zelen randomised control trial, with all non-emergency     adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year     period being randomised to either treatment as usual (TAU) or TAU plus access to the MotivATE     intervention prior to their assessment appointment.   "
38786|NCT02777931|"     This is a randomized, double-blind, placebo-controlled, parallel-group study of NFC-1 versus     placebo in adolescents with ADHD who have genetic disorders impacting mGluRs.   "
38787|NCT02777918|"     This is an intervention study, aiming to increase protein intake, by increasing egg     consumption in community dwelling older adults aged 55 years and over, by providing recipes     to increase flavour and variety in egg dishes.   "
38788|NCT02777905|"     About 10-20% of older patients in primary care suffer from symptoms of depression and/or     anxiety. Depression and anxiety are associated with higher rates of cognitive decline, lower     quality of life, increased medical comorbidity, and higher mortality rates in these patients.     Given the world's aging population and consequent rapid increase in older patients in primary     care, many traditional therapeutic approaches for depression or anxiety in this patient     population - e.g. assessment by a mental health practitioner, individual psychotherapy and/or     appropriate psychotropic medication - have been inadequate, with many patients having     undetected depression and anxiety. Additionally, geriatric depression and anxiety are very     common, but difficult to treat with psychotropic medications: patients are more sensitive to     adverse effects and respond relatively less well to medication.      To help with this issue, the investigators are conducting a randomized controlled trial of     mindfulness-based cognitive therapy (MBCT), a treatment that has been highly effective in     treating depression and anxiety, but has not yet been assessed in older adults. There has     been relatively little information about MBCT's effectiveness, particularly in the primary     care setting and in the acute treatment of depression and anxiety(vs. maintenance treatment).      This study will be conducted in 75-100 older adults in primary care with symptoms of anxiety     and depression. The study will take place in the centre local de services communautaires     CLSC Benny Farm, a primary health care centre in Montreal, Canada. Most patients aged 60+     with symptoms of depression (Patient Health Questionnaire 9 (PHQ-9) score ≥10) or anxiety     (General Anxiety Disorder-7 (GAD- 7) score ≥10) will be eligible. Patients who are eligible     for the study will be randomized: half the patients will get 8-week MBCT with a trained     interventionist (occupational therapist, psychiatry resident, or psychiatrist). The other     half (control group) will get patient treatment as usual with patient primary care     physician/primary care team during the study, but then after the study, patients will be     offered the treatment if patients would like.   "
38789|NCT02777892|"     Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.      The aim of the registry is to document the feasibility and safety of implanting an Edwards     SAPIEN S3 transcatheter heart valve in the pulmonic position   "
38790|NCT02777879|"     This is a cross sectional case controlled study to assess lung microbiome and inflammation in     smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will     look at active bacterial metabolic pathways in the lower airways using metagenomic and     metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and     host immune responses in COPD and controls. Investigators believe COPD cases will have higher     prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.   "
38791|NCT02777866|"     The purpose of this study is to determine if the infiltration of 0.5% Bupivacaine in the     surgical wound is effective to diminish the pain and the risk of surgical site infections in     patients who go to a open gastrointestinal procedure.   "
38792|NCT02777853|"     The aim of this research is to explore changes in peripheral/cerebrovascular function and     insulin sensitivity after a 7-day combination of physical activity reduction (-50% steps per     day) and overfeeding (+50% kcal per day, comprising 65% fat) in healthy male volunteers, and     examine whether daily intake of tea can prevent such changes.   "
38793|NCT02777840|"     High flow oxygen results in better oxygenation in emergency cases needing rapid sequence     induction for anaesthesia. Secondary outcome measure is time for any desaturation.   "
38794|NCT02777827|"     The purpose of this study is to investigate the pharmacodynamics of single doses of     abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is     a potential for once daily treatment of asthma and chronic obstructive pulmonary disease     (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel     anti-inflammatory agent. The aim of the clinical studies is to enable further investigations     in participants with asthma and COPD to evaluate and develop abediterol as an effective long     acting bronchodilator with an acceptable safety profile compared to other inhaled     bronchodilators on the market, for the treatment of asthma and COPD.   "
39719|NCT02765724|"     This is an open-label, parallel-group, single-dose study of the PK and safety of 400 mg     pacritinib administered orally to patients with stable chronic liver disease and healthy     control subjects.   "
38795|NCT02777814|"     There has been no report on whether the patients with colorectal cancer who are also inactive     Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug     Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the     prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of     patients with colorectal cancer who are also inactive hepatitis B carriers during     chemotherapy and the subsequent follow-ups.   "
38796|NCT02777801|"     There has been no report on whether the patients with gastric cancer who are also inactive     Hepatitis B carriers should receive prophylactic use or preemptive Use of an Anti-viral Drug     Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the     prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of     patients with gastric cancer who are also inactive hepatitis B carriers during chemotherapy     and the subsequent follow-ups.   "
38797|NCT02777788|"     The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese     patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the     adverse reaction and the reliability.   "
38798|NCT02777775|"     The purpose of the research study is intended to use specimens (such as tissue) and medical     information in the Laboratory of Musculoskeletal Oncology at the Van Andel Research Institute     for laboratory research in Grand Rapids, Michigan. Small tissue samples of cutaneous     neurofibromas will be collected as part of this research. The samples will help researchers     learn more about cutaneous neurofibroma and help them better understand NF1. There are many     different types of studies, both now and in the future, that can be done using the specimens     they receive. These include using the specimens and information to look for new ways to     diagnose and treat Neurofibromatosis Type 1 (NF1). The specimens may be used to study how     genes affect health and disease, or how genes affect the way a disease or condition responds     to treatment. Some of these studies may lead to new products, such as treatments or tests for     diseases. Through this study, we hope to find better ways to understand and treat NF1 in the     future.   "
38799|NCT02777762|"     Getting regular physical activity has many health benefits. Current physical activity     programs often encourage people to track their physical activity as a way to motivate them to     continue being physically active over time. However, not everyone enjoys physical activity,     so tracking physical activity may not be very motivating. This research study will evaluate     whether a new program—specifically designed to enhance people's enjoyment of physical     activity—improves people's attitudes toward physical activity compared to a program that     encourages people to track their physical activity with a mobile app.   "
38800|NCT02777749|"     The objective of the study is to compare the efficacy of adductor canal blocks versus     periarticular bupivacaine injections for pain management in total knee arthroplasty. This     randomized clinical trial will compare outcomes between adductor canal blocks, periarticular     bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this     study will help determine the most appropriate perioperative pain management strategy for     patients undergoing a total knee arthroplasty.   "
38801|NCT02777736|"     Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell     lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either     with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal     methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS     prophylaxis (arm C).   "
38802|NCT02777723|"     The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with     dry eye syndrome   "
38803|NCT02777710|"     Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common     gastrointestinal cancers in Western countries and are both associated with significant     morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the     newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have     limited efficacy as single agents in both of these tumor types. Recent preclinical studies     point towards alternatively activated (M2-type) macrophages as possible culprits in inducing     local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents.     We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages,     thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1     blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose     escalation study in order to evaluate the safety and clinical activity of a combined     treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in     patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will     determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of     Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical     activity of the combination at the RP2D.   "
38804|NCT02777697|"     The aim of this study is to investigate the predictive dimension of cognitive-emotional     status of cancer patients on the chronic pain development 6 months after different cancer     treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy     ...).   "
38805|NCT02777684|"     This study sought to better identify the motivators and barriers to osteoarthritic patients     practising regular physical activity. This is a crucial step towards enabling each health     professional to adapt their therapy recommendations, while taking into account the patient's     overall lifestyle.   "
38806|NCT02777671|"     Single centre, randomised, open-label, two-way crossover study to investigate whether     multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the     pharmacokinetics of gliclazide.   "
38807|NCT02777658|"     The objectives of this study are to assess molecular testing, treatment patterns, and     associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor)     mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have     progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of     a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment     patterns will be assessed among a secondary cohort of patients which will include patients     diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.   "
46258|NCT02680119|"     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule     1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA.     Dosing periods of studies were separated by a washout period of 5 days.   "
38808|NCT02777645|"     The nutritional status of CP children may be decreased when children have chewing disorders     too due to insufficient solid food intake. The objective of this study was to investigate     growth, dietary intakes and feeding behaviours of children with CP who have chewing     disorders, and to compare them with their healthy peers.   "
38809|NCT02777632|"     The purpose of this work was to study the incidence, types, risk factors and causative     organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation.     Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy   "
38810|NCT02777619|"     The purpose of this study is to determine pharmacodynamic interactions of propofol and     dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median     effective concentration (EC50).   "
38811|NCT02777606|"     The purpose of this study is to evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal Formula     documented in Shang Han Lun) in treating severe sepsis.   "
38812|NCT02777593|"     The objective of this study is to determine whether the GORE® TAG® Thoracic Branch     Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending     thoracic aorta.   "
38813|NCT02777580|"     In elderly patients ≥ 70yrs with acute ST-elevation myocardial infarction randomised within 3     hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic     treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose     of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by     catheterisation within 6-24 hours or rescue coronary intervention as required, will be     compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment     according to local standards.   "
38814|NCT02777567|"     The objectives of this study are to assess the safety and efficacy of single agent Tagrisso     (Osimertinib, hereinafter the study drug) in a real world setting in adult patients with     advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive     Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase     receptor (TKI) therapy.   "
38815|NCT02777554|"     This study will be conducted in 2 Parts. The purpose of this study is to measure how much of     apremilast is found in the blood when administered as a once daily tablet compared to a twice     a day tablet, when given as multiple doses (Part 1) and when administered as a single dose     under fasting and fed conditions (Part 2). Information on the safety and tolerability of     apremilast will also be obtained. In addition, the effect of apremilast on certain biomarkers     in the blood will be evaluated in 16 assigned subjects (Part 1 only). Biomarkers are     substances such as proteins that tell us how the study drug is working in your body.      Part 1: This is a multi-center, phase 1, open-label, randomized, two-period, two-sequence,     crossover study in healthy subjects. The study will consist of a screening phase, a baseline     phase, two treatment periods, and a follow-up phone call. Each Period will be ten days in     duration (Day 1 through Day 10) for dosing and sample collection for up to 72 hours post Day     7 morning dose of Periods 1 and 2. There will be a washout between Period 1 and Period 2.     Part 2: This is a single center, open-label, randomized, four-period, four-sequence crossover     study to evaluate the PK and exposure of apremilast following single dose administration of     different formulations of apremilast. Part 2 will consist of a Screening phase, Baseline,     four Treatment periods, and a follow-up phone call. Each Period will be four days in duration     (Day 1 through Day 4) for dosing and sample collection for up to 72 hours post Day 1 of     Period 1, 2, 3, and 4.   "
38816|NCT02777541|"     There aren't sufficient randomized prospective controlled trials in pediatric population     comparing the safety and tolerance of early feeding after PEG placement (3-4 hours). Most     patients are fasted for at least 12 hours following percutaneous endoscopic gastrostomy. In     order to decrease the period of fasting, inadequate nutritional support, and hospitalization     time, the investigators decided to design this study. The additional goal is to establish an     optimum standard procedure in the group of pediatric patients qualified for PEG insertion     procedure in Poland.   "
38817|NCT02777528|"     The objective of this study is to determine whether the GORE® TAG® Thoracic Branch     Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending     thoracic aorta.   "
38818|NCT02777515|"     Justification Smoking is a major factor for mortality and cardiovascular morbidity. The     electronic cigarette, sometimes presented as smoking cessation classic is expanding but its     safety has not been established to date. The smoke from the electronic cigarette is mainly     composed of propylene glycol, some adverse effects were observed in animals.      Study Type interventional study assessing the effect of the electronic cigarette Inclusion     criteria Topics under 35 years presenting to Rhythm of the consultation for a cardiovascular     evaluation and already smoking the electronic cigarette and that for at least 1 month      Exclusion criteria        -  Consumption of traditional cigarettes, nicotine replacement or toxic        -  Presence of heart disease Primary objective To evaluate in a pilot study the immediate          cardiovascular effects of electronic cigarette consumption Number of patients 20          Duration of Study Recruitment in 2015 for an unlimited period of inclusion. Exam time is          about two hours.      Procedures performed during the study Physical examination, ECG, Holter-ECG 10 minutes and     echocardiography were performed before and 15 minutes after the consumption of the usual     electronic cigarette of the subject.      No additional follow-up visit is required   "
38819|NCT02777502|"     The purpose of the proposed study is to investigate the effectiveness of cannabidiol for     reducing marijuana seeking in non-treatment seeking volunteers. Cannabidiol is a cannabinoid     (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of     marijuana.      Assess the ability of acute smoked CBD pretreatment to reduce marijuana-seeking behavior and     increase price-elasticity of marijuana demand.   "
38842|NCT02777203|"     The purpose of this study is to determine the safety and efficacy of insufflated bags for     electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for     tissue removal and to observe the integrity of the bags throughout and after insufflation and     power morcellation.      The hypothesis is the bags will remain in tact without leakage from the bags during and after     power morcellation using the described contained system, confirming the safety and efficacy     of the systems.   "
46259|NCT02680106|"     Evaluation of safety and performance of the SPINNER device and wound dressing in the     treatment of donor-site wounds (DSW)   "
38820|NCT02777489|"     The primary objective of this study is to evaluate the Carboxipeptidase D (CPD) genotyping as     a predictive biomarker of body weight and/or fat mass reduction in obese patients treated     with perindopril.      There is nonclinical and clinical evidence that a subgroup of human subjects may present a     decrease in body weight and/or fat mass following treatment with perindopril. Although the     individual characteristics that determine such effect are still unknown, Gene PreDiT SA     (Biocant Park, Cantanhede, Portugal) discovered that certain genetic characteristics (e.g.,     single nucleotide polymorphisms (SNPs) of CPD gene) may play a role and potentially could     serve as a potential predictive biomarker of response to perindopril.      These promising results, along with the fact that perindopril is a medicine already in use in     clinical practice, led Gene PreDiT SA to decide to proceed with the development of a     theranostic approach for the treatment of obesity. Such theranostic approach consists on the     use of CPD genotyping to identify obese subjects that could present improved body weight and     fat mass reduction following treatment with perindopril.      The current clinical trial aims to prove the concept and provide data to design further     confirmatory studies. Additionally this study will evaluate the association between CPD SNPs     genotypes and response to perindopril; the effect of perindopril in waist circumference,     waist/hip ratio, and BMI and the tolerability and safety of perindopril in the study     population.   "
38821|NCT02777476|"     This is a post-marketing study for B-Lite® implants that carry the EC certificate for     marketing in Europe and AMAR certificate for marketing in Israel. To date, hundreds of     implants have already been implanted in women. The study is open for primary augmentation     patients only. All surgeries will be performed as per standard practice at the given study     site. No parallel surgical procedures will be performed at the same session.   "
38822|NCT02777463|"     To investigate the correlation between pretreatment ADC value of diffusion MRI and pathologic     response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant     therapy.   "
38823|NCT02777450|"     This study evaluates the predictor value of manual test in lumbar chronic patients blocks.     Bibliography has show limited evidence of clinical predictors in lumbar blocks. Prior to     lumbar facet block or medial branch denervation patient will be evaluated with manual     provocative segmental movements, lumbar sagittal range of motion, manual segmental movement     and slump neural test . Immediate, one and six months effect will be registered.   "
38824|NCT02777437|"     Primary Outcome Measures: Disease free survival      Secondary Outcome Measures:      Overall survival      Adverse events (Mortality, morbidity)      The proportion of completion of Laparoscopic Surgery      Estimated Enrollment: Oct, 2016      Study Start Date: Oct, 2016      Estimated Study Completion Date: Oct, 2019      Estimated Primary Completion Date: Oct, 2021      Groups/Cohorts        1. Laparoscopic surgery for T4 colon cancers        2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers   "
38825|NCT02777424|"     This prospective, randomized, multicenter study is performed to determine whether prothrombin     complex concentrates confers any benefits over fresh frozen plasma in adult neurological     patients with coagulation disorders (PT value less than 60%).   "
38826|NCT02777411|"     The objectives of this study are to evaluate the immune response and safety profiles of two     injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg     and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required),     0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.   "
38827|NCT02777398|"     Intra-spinal canal tumors are the general term of primary tumors from spinal cord or various     tissues in the spinal canal and adjacent to the spinal cord, while the metastatic tumors are     those from other sites other than spinal canal. Intra-spinal canal tumor is one of the most     common diseases in neurosurgery, and surgery is the most effective treatment. Conventional     open surgery is required to remove the posterior structures of the spine, which would lead to     fracture of the posterior tension band, soft tissue injury, spine instability, and even spine     deformity. So it is very important to protect and rebuild the posterior tension band for the     stability of the spine. The team of Dr. John P. Kostuik from the Department of Orthopedics     and Neurosurgery, the Johns Hopkins University, firstly introduced minimally invasive surgery     for cervical and lumbar degenerative disease. However it has not been applied to the     treatment of intra-spinal canal tumors. To date, the microsurgery of intra-spinal tumor     through the trans-Quadrant channel pathway has not been widely performed in clinical     practice. The investigators performed the microsurgery of intra-spinal canal tumor through     the trans-Quadrant pathway in some patients previously and succeeded in the surgical     treatments. The investigators analyzed the clinical data retrospectively, including surgical     incision length, the volume of bleeding during operation, post-operative drainage volume,     post-operative out-of-bed time point, post-operative length of stay in hospital, and     post-operative visual analog pain (VAP) score. The group of patients using microsurgical     technique through trans-Quadrant channel pathway showed better outcome compared with the     group of patients using conventional open surgery. This innovation of microsurgery showed     fewer traumas and bleeding, more rapid recovery, better prognosis and more safety in     practice. Since there are some limitations to the retrospective study, it is necessary to     design a prospective randomized controlled trial of the treatment of intra-spinal canal     tumors using microsurgical technique through trans-Quadrant channel pathway.   "
38828|NCT02777385|"     The study regimen consists of cisplatin and radiation for all patients, the standard     treatment for head and neck cancer. All patients will also receive pembrolizumab (the study     drug), and will be randomized to two treatment schedules: either pembrolizumab with     cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation.      The goal of this research study is to learn which therapy order (adding pembrolizumab during     vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as     well as learn the side effects of these combinations.Pembrolizumab is an immune therapy, a     drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer     and melanoma. It is not currently FDA approved for head and neck cancer.   "
38829|NCT02777372|"     This is a pilot study that aims to evaluate the psychophysiology of premenstrual mood     disorders (PMDs) at baseline and after treatment with sertraline. Participants will include     women with PMDs and healthy male and female controls. Participation involves a baseline visit     to determine eligibility and three study visits that include questionnaires and stress     reactivity assessment via an acoustic startle paradigm, cortisol, and immune markers, as well     as hormone and genetic measures. Female participants with PMDs will receive sertraline during     the premenstrual phase.   "
38843|NCT02777190|"     The purpose of this study is to study if misoprostol administered orally is at least as     effective as misoprostol administered vaginally for cervical ripening and the induction of     labor. The main purpose is to show that oral misoprostol administration is non-inferior to     vaginal misoprostol administration with respect to the time interval from misoprostol     administration to onset of active phase of labor. The study is a non-inferiority, prospective     randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus     vaginal misoprostol given as 25 mcg every 4 hours.   "
38830|NCT02777359|"     The foramen ovale, a kind of physiologic channel in the interatrial septum in the heart at     embryonic stage, is closed normally at 5-7 months after birth. When it is not closed, it is     referred to as the patent foramen ovale (PFO), which is found in approximately 1/4 of general     population. It was shown in the studies in recent years that the risks of cryptogenic stroke,     migraine, peripheral arterial embolism and decompression sickness in the patients with PFO     were several times higher than those in healthy people. Therefore, PFO, previously considered     a condition without the necessity of treatment, causes the attention of many experts and     scholars around the world. Migraine with or without aura is defined as one of the most     disabling chronic diseases, since according to WHO, the disability adjusted life year caused     by migraine was second only to that by non-fatal stroke in 2005. In recent years, an     increasing number of researches suggested that migraine is closely related to the     right-to-left shunt (RLS) in the heart. And PFO is clinically considered as the most common     cause of RLS.      The closure treatment for PFO-induced migraine has been gradually applied in several     hospitals in China. The relationship of PFO with migraine, however, was not evaluated     systematically based on specific standards, unfortunately leading to non-inclusion of many     high-risk patients with PFO in the evaluation. The following aspects are to be fully     recognized: the selecting and screening procedures for the high-risk population with     PFO-induced migraine; the indications and standards of closure treatment for PFO in the     patients with PFO-induced migraine; and the possibility that the made-in-China occluders     substitute for those imported in the prevention from migraine. Furthermore, there is still a     lack of prospective, multi-center, randomized and controlled studies in this subject, and     standard or normal screening and treatment procedures have not yet been established in China.     From this point, the investigators developed the Chinese people-specific procedures and     standards of diagnosis of PFO-induced migraine in this study, based on current standards and     methods of diagnosis, treatment and prevention of PFO-induced migraine in foreign countries.     And the investigators prospectively adopted continuous inclusion of the high-risk patients     with PFO-induced migraine, who were randomly divided into the closure treatment     (transcatheter closure of PFO) group and the medication (drugs administered alone) group at     the ratio of 1:1., in order to evaluate if the interventional treatment is better than the     medication alone in these patients, to assess the efficacy and safety of the made-in-China     occluders in the interventional treatment and prevention of PFO-induced migraine, and to     identify the incidence of PFO in the patients with migraine in China and develop the Chinese     people-specific screening protocols of PFO-induced migraine.   "
38831|NCT02777346|"     The investigators recruit patients admitted to the Pediatric Emergency Department of the     Geneva's University Hospital with open wounds needing suture. The patients are treated with     absorbable versus non-absorbable suture material according to randomization.      Outcomes are:        1. infection rate at the first follow-up (between 4 and 14 days, depending on the sutured          site and defined by protocol)        2. scar appearance at a 6-months follow-up.   "
38832|NCT02777333|"     The purpose of this study is to determine whether simulation training improves the     performance during arthroscopic surgery ('keyhole' surgery into a joint).   "
38833|NCT02777320|"     Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for     the pain treatments.      The objective of the study was to assess whether intravenous Paracetamol has superior     Sciatica pain reduction will compare with Ibuprofen in emergency department (ED) adults.      Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.   "
38834|NCT02777307|"     Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing     of postperative fluid collection after laparoscopic cholecistectomy, morbidity and     postoperative hospital stay.   "
38835|NCT02777294|"     Rape is unfortunately a common experience among women, affecting between 13 and 20%. In     addition, up to 50% of all rape victims experience significant and persistent psychological     distress. While cognitive-behavioral interventions have been found to be successful at     alleviating distress among victims; the majority do not seek out these services, often     because of feelings of stigma and self-blame. One potential method for circumventing these     barriers is through online administered treatment. Thus, the current project is designed to     conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media,     cognitive-behavioral, online intervention tailored specifically for rape victims. The     effectiveness of this program at ameliorating distress among college women who have     experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated.     Reductions in psychological distress was the primary outcome and was assessed at     post-intervention and at three and six month follow-up periods. The effectiveness of the     intervention was compared to a psycho-educational website.   "
38836|NCT02777281|"     This study will compare two exercise programs in an interventional study for manual     wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord     injury will also be enrolled to compare exercise approaches.   "
38837|NCT02777268|"     This was a single centre, open-label, randomised, 5-way crossover study.   "
38838|NCT02777255|"     Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of     pathogenetically-related biomarkers, and specific RNA expression changes in the blood   "
38839|NCT02777242|"     Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single     dose via QuickShot® Testosterone (QST) 50 mg, 75 mg, or 100 mg when administered by intended     users in a usability study.   "
38840|NCT02777229|"     Several reports indicate that treatment failure due to HIV resistance or to adverse     event-related discontinuation could compromise the effectiveness of scaling-up antiretroviral     treatment (ART), especially when lack of access to viral load is a concern. Combined with     other nucleoside reverse transcriptase inhibitor, Dolutegravir (DTG) is a very promising     alternative to the current first-line non nucleoside reverse transcriptase inhibitor-based     regimens.      Initial evaluations of DTG conducted in high income countries showed excellent efficacy and     safety and indicated high genetic barrier thus preserving second line treatment. As a     consequence, DTG-based regimens have been recently included in the first-line options in the     national guidelines for ART of several high-income countries. However, the clinical trials     evaluating DTG-based regimens have been conducted in highly controlled conditions, including     baseline resistance testing and regular viral load monitoring. Moreover, these trials     included a high proportion of men with rare co-morbidities.      There is need to evaluate how a DTG-based regimen will perform in real-world conditions     within resources-constrained settings, where viral load monitoring is limited, and where the     majority of HIV patients are women with important family planning consideration and NAMSAL     trial is a randomized clinical trial which aims to evaluate efficacy and safety over 48 weeks     of DTG + tenofovir disoproxil fumarate/lamivudine versus Efavirenz (EFV) + tenofovir     disoproxil fumarate/lamivudine in 606 ART-naïve HIV-1-infected adults in Cameroon. A set of     efficacy and safety endpoints will be compared over 48 weeks between the two arms including     the proportion of patients with viral load <50 copies/mL and incidence of severe adverse     events.   "
38841|NCT02777216|"     To evaluate the safety and performance of the ConfidenHT System   "
39720|NCT02765711|"     This is a single-arm non-interventional cohort study. This study is to describe the     contemporary use of ticagrelor in a real-world setting, to reflect its acceptance and     patients' compliance, and to observe its one-year safety in patients with acute coronary     syndrome in Fuwai Hospital.   "
38844|NCT02777177|"     Bariatric surgery is a powerful tool for producing significant and durable weight loss. Yet,     not all patients achieve initial weight loss success and many patients have weight regain as     early as 1-2 years post-surgery. Suboptimal weight loss patterns not fully explained by     surgical, demographic, and medical factors has led to greater emphasis on patient behaviors     evidenced by clinical guidelines that focus on appropriate eating and physical activity.     However, research to inform such guidelines typically has relied on imprecise measures or not     been specific to bariatric surgery. There is also little understanding of mechanisms by which     psychosocial factors influence outcomes. Thus, there is a need to: (a) measure behaviors and     psychosocial factors thought to be related to surgical outcomes (particularly those     emphasized in guidelines) using innovative strategies to maximize data quality, (b) determine     which behaviors and psychosocial factors are related to outcomes, and (c) explore how     psychosocial factors influence weight both directly and via influences on behavior. Our     research team was the first to employ innovative mobile health (mHealth) technology within an     Ecological Momentary Assessment (EMA) framework to measure adherence to recommended behaviors     at 6 months post-surgery. The investigators propose to build on this work by using EMA to     measure behavioral, psychosocial, and environmental factors over a longer period to     understand how they predict success and risk after surgery. An NIH-funded multi-sensor PiLR     HEALTH platform will integrate objective sensor data measuring behaviors and the environments     in which they are performed with self-report information collected via smartphone in     real-time and in patients' natural environment. Participants (N=100) recruited from 2     ASMBS-designated centers of excellence will complete a 10-day EMA protocol pre-surgery and at     3, 6, and 12 months post-surgery to assess recommended behaviors [e.g., meal frequency, PA],     psychosocial indicators with the most prior evidence of an association with surgical outcomes     (e.g., mood/depression), and key environmental factors (e.g., type/quality of the food     environment). Participants will also be weighed at the above time points. Along with     describing patterns in behaviors and their relation to weight loss, the investigators will     test causal models to understand how complex systems of behavioral, psychosocial, and     environmental factors affect weight loss, and to identify optimal targets for intervention.     This project has the potential to build a much more sophisticated and valid understanding of     who is and is not successful after bariatric surgery and why. This new understanding will     directly contribute to improved (i.e., specific, consistent, and validated) guidelines for     recommended pre and postoperative behaviors, which could lead to improved surgical outcomes.     The enhanced understanding will also inform behavioral, psychosocial, and environmental     targets for intervention that are mostly likely to improve surgical outcomes.   "
38845|NCT02777164|"     The purpose of the study is to estimate the diagnostic accuracy of cancer detection when the     MIRA technology is combined with mammography, in women above 30 years old who are undergoing     screening mammography or are scheduled for image-guided needle biopsy due to lesions detected     by other imaging modalities.      The hypothesis is that breast cancer screening based on functional imaging will result in the     early detection of breast cancers, at times predating mammographic conspicuity. In addition,     breast cancer screening based on functional imaging will be unaffected by breast density.     therefore, the combination of anatomic screening (mammography) and functional imaging based     screening (MIRA) will result in significantly higher breast cancer detection rates in women     with dense breast tissue by indicating the need for additional breast imaging technology,     usually MRI.   "
38846|NCT02777151|"     This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study     evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of     REGN3470-3471-3479 in healthy adult volunteers.   "
38847|NCT02777138|"     The accumulation and dysfunction of excess adipose (fat) tissue that occurs with ageing is     associated with a number of chronic inflammatory disorders such as type 2 diabetes and     cardiovascular disease but the underlying mechanisms are not understood.   "
38848|NCT02777125|"     This study is determines if metered dose inhalers are as effective as breath actuated     nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients     presenting to the emergency department. Half of the participating patients received albuterol     via the metered dose inhaler whereas the other half received albuterol via the breath     actuated nebulizer.   "
38849|NCT02777112|"     There is a pressing need for innovation in prevention of major depression in male workers.     Major depression (MDE) affects workers' health and productivity. In the United States,     workers with depression cost an estimated US $44.01 billion per year in lost productivity.     One of the severe consequences of having MDE is potential suicide and Canadian national data     showed that 76% of all suicides in 2009 were male. In the workplace, risk factors for having     MDE differ for men and women. For instance, job strain, family to work conflict and job     insecurity seem to be more prominent MDE risk factors in men than in women. Compounding men's     risk, men are less likely than women to seek help and to disclose depressive symptoms and     often delay help seeking until symptoms become severe. Men are socialized to be emotionally     stoic and exemplify traditional masculine characteristics such as independence, self-reliance     and dominance. Men are concerned over the perceived negative judgments from family and     friends if they access treatment for depression. These gender specific experiences along with     a limited knowledge base about effective interventions call for innovative solutions tailored     for men. The proposed study was to evaluate the effectiveness of an e-mental health program     on reducing the risk of major depression in Canadian working men.   "
38850|NCT02777099|"     The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC)     initiates autonomic nervous system response and affects the prognosis in patients with acute     ischemic stroke.   "
38851|NCT02777086|"     The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR2) Project is     to develop and test a self-administered tablet computer app, StaySafe, for probationers under     community supervision that is designed to improve decision-making skills around health risk     behaviors, especially involving HIV and hepatitis B & C risks. StaySafe utilizes materials     and concepts adapted from an earlier, group-based curriculum, WaySafe, designed to increase     positive decision-making skills for offenders in the last phase of their prison-based     substance abuse treatment before transitioning back to the community.   "
38852|NCT02777073|"     1. To compare levels of ketone bodies (beta-hydroxybutyrate and acetoacetate) in plasma and          urine following a single dose treatment of either liraglutide 1.8mg,dapagliflozin 10mg          or placebo in insulinopenic state.        2. To compare plasma levels of free fatty acid, glucagon, hs-CRP, Il-6 and IL-1 before and          after administration of liraglutide/Dapagliflozin/placebo.   "
38853|NCT02777060|"     Explore the benefit of the game-based virtual reality system in improving lower extremity     kinematics and balance in patients suffering from disease/disorders including Diabetes,     Cancer, Multiple Sclerosis, Arthritis, Parkinson's disease, Cognitive Disorders, Brain     Injury, Stroke or Frailty. A four to six weeks of training with 2 training session/week will     be provided.   "
38878|NCT02776735|"     Primary Objective:      To describe the pharmacokinetic (PK) profile of sarilumab in patients with pcJIA in order to     identify the dose and regimen for continued development in this population.      Secondary Objective:      To describe:        -  The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients          with pcJIA.        -  The long-term safety of sarilumab in patients with pcJIA.   "
38854|NCT02777047|"     Oral anticoagulants (warfarin, dabigatran, rivaroxaban and apixaban) are the very top cause     of serious drug-related harm. More than 7 million prescriptions are dispensed annually for     oral anticoagulants (OAC) in Canada, with more than 340,000 recipients in Ontario Drug     Benefit Program alone. Because of their very high and chronic utilization, their large     benefit in lowering important clinical events (stroke, embolism, death) and their high     potential for major harm (primarily bleeds, which can be fatal), OACs are the highest     priority for improving medication safe and effective use. The early period after hospital     discharge is clearly high risk, with three times the usual rate of major bleeds compared with     later. Since healthcare has been declared unsustainable in its current delivery form, it is     time that Hamilton hospitals took the lead in finding more cost-effective ways to improve     anticoagulation safety. The investigators will do this by structuring discharge medication     assessment, with formal handover to telehealth coordination and communication with patients     and their providers, to extend access and reduce the cost of expert anticoagulation guidance.     This innovative study will rigorously and efficiently address whether a focused care     coordination intervention targeting the highest priority medication safety topic     (anticoagulants), delivered by telehealth experts already providing other services for     Ministries of Health, can improve outcomes and reduce costs of care. The rigorous research     design tests whether high quality, easily scalable, teletriage coordination can be effective     in preventing anticoagulation-related adverse events during the most risky time period of     therapy - transition from hospital to home.   "
38855|NCT02777034|"     Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a     traditional recovery pathway after ileocolon resection for Crohn's Disease.   "
38856|NCT02777021|"     Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens     that result in periods of profound neutropenia leaving patients susceptible to severe     infectious complications. Infectious complications are the leading cause of treatment related     mortality among AML patients, but there are little clinical data to inform whether management     of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting.     Further, no studies have been conducted that assess the impact of neutropenia management     strategy on the quality of life of pediatric patients with AML and their caregivers.   "
38857|NCT02777008|"     Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.   "
38858|NCT02776995|"     This research aims to investigate the correlation between tumor temperature difference and     biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.      In addition, normal tissue response to adjuvant radiation therapy in treated organs following     surgery, will be evaluated.   "
38859|NCT02776982|"     This study is being done to help understand why some people with an increased amount of     central obesity, without gastroesophageal reflux, develop changes to the lining of their     esophagus that can potentially lead to esophageal adenocarcinoma (cancer).   "
38860|NCT02776969|"     The aim of this project is to identify genetic risk factors associated with familial     papillary thyroid carcinoma (PTC). Papillary thyroid cancer is a type of cancer that shows     high heritability. However, the specific genetic factors that cause an increased risk have     been elusive.   "
38861|NCT02776956|"     A total of 120 patients with persistent atrial fibrillation (including continuous and     long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial     fibrillation will receive radiofrequency ablation. Patients in each group will be randomly     allocated into the statin treatment group and non-statin treatment group (allocation ratio,     1:1). Left atrial appendage flow velocity of all patients are measured by Transesophageal     Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of     left atrial function are carried out for all patients before the operation and after the     operation. Blood samples are extracted in all patients before the operation and after the     operation. This study will clarify whether the application of statin drugs can improve     postoperative left atrial function. This study will identify the time course and influence     factors of left atrial recovery of atrial fibrillation after the operation to guide the time     and the degree of anticoagulation and effectively prevent thromboembolic events. At the same     time, biochemical indicators are detected to analyze which indicators are related to the     postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis     and the recovery of postoperative left atrial function. Furthermore, this study will     investigate whether the application of statin drugs can improve postoperative left atrial     function by affecting these indicators.   "
38862|NCT02776943|"     The purpose of this study is to investigate the efficacy and safety of transplantation of     umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.   "
38863|NCT02776930|"     The purpose of this study is to develop algorithms that will help predict future injury     and/or re-injury after being returned to duty from a musculoskeletal injury. After completion     of an episode of care with a physical therapist, the subjects will undergo a battery of     physical performance tests and fill out associated surveys. The subjects will then be     followed for a year to identify the occurrence/re-occurence of any injuries. Based on the     performance on the physical evaluation tests, algorithms will be derived using regression     analysis to predict injury.      Subjects will be recruited from the pool of patients that have recently completed physical     rehabilitation in physical therapy clinics for their lower extremity or lumbar/thoracic spine     injury.   "
38879|NCT02776722|"     Despite advances in the prevention and treatment of type 2 diabetes, its prevalence continues     to rise worldwide. There is a need for new modalities to improve metabolic control in     individuals with type 2 diabetes and those who are overweight or obese and at risk for type 2     diabetes. Contrary to the concerns raised about the adverse role of fructose in metabolic     health, various lines of evidence suggest that fructose and its epimers may improve the     metabolic handling of glucose through inducing glycogen synthesis. Recent small trials in     humans suggest that catalytic doses (=<10g/meal) of fructose and its epimers (allulose,     tagatose, and sorbose) may reduce postprandial glycemic responses to carbohydrate loads     (i.e., oral glucose tolerance test or a starch load) in people with and without type 2     diabetes. There is also limited evidence that these acute effects may manifest as longer term     improvements in glycemic control. There is an urgent need to synthesize the evidence of the     effects of fructose and its epimers on postprandial carbohydrate metabolism.   "
38864|NCT02776917|"     The purpose of the study is to investigate the safety of the investigational drug called     cirmtuzumab in combination with the breast cancer drug paclitaxel. Cirmtuzumab is a type of     drug called a monoclonal antibody. This drug is designed to attach to a protein called ROR1     that is on the surface of breast cancer cells. This blocks growth and survival of the breast     cancer cells. ROR1 is rarely expressed on healthy cells so this drug should target the cancer     cells. Cirmtuzumab is considered experimental because its use is not approved by United     States (U.S.) Food and Drug Administration (FDA).      Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease the     number of breast cancer cells, we do not know if this will work in humans. This drug has been     tested in humans before, but has never been tested in patients with breast cancer, or in     combination with paclitaxel in humans. Therefore, the goal of this study is to see if     cirmtuzumab is safe and tolerable, when in given in combination with paclitaxel in study     participants. You will be evaluated to find out what effects (good and bad) cirmtuzumab has     on you and we would like to learn more about how cirmtuzumab might affect the growth of your     cancer cells. We would also like to see how long the drug stays in your body and what affects     the drug may have on your body.   "
38865|NCT02776904|"     Previous work in the area of concussion management has focused heavily on neuro-cognitive     testing. In addition to routine neuro-cognitive testing through Immediate Post-Concussion     Assessment and Cognitive Testing (ImPACT),this pilot study is designed to establish a     comprehensive battery of clinical assessment through the utilization of functional movement     and dynamic postural control assessments. The immediate application of these assessments will     be focused on the male high school football player (who is at risk for concussion) and both     female and male soccer players.. Our pilot study aims determine the stability of ImPACT     testing in youth athletes in light of ongoing neurodevelopment in this population. In     addition, this pilot work will implement additional tools focused on assessment of dynamic     balance, reaction time, and agility. This approach will significantly enhance predictions of     subsequent musculoskeletal injuries that have been shown to occur in concussed collegiate and     professional athletes and that we believe are also occurring in our high school athletes.     This battery of tests will provide clinicians with invaluable information to guide both     rehabilitation of and return to play (RTP) decisions for concussed high school athletes. This     pilot study will further track those athletes who sustain a concussion and assess increased     risks for musculoskeletal injury.   "
38866|NCT02776891|"     This is a single center imaging study investigating the use of PET with 68Ga-citrate in     patients with DLBCL or BCLU.   "
38867|NCT02776878|"     The purpose of this study is to determine whether dasatinib is effective and safe in the     treatment of refractory metastatic gastrointestinal stromal tumor   "
38868|NCT02776865|"     This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid     under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating     adhesive capsulitis   "
38869|NCT02776852|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
38870|NCT02776839|"     The objective of this study is two fold, first to explore the potential of context sensitive     intervention delivery to provide in-situ support for people with depressive symptoms, second     to explore the detection of daily-life behavior based on smart phone sensor information to     identify subjects with a clinically meaningful depression level.   "
38871|NCT02776826|"     The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international,     observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the     feasibility of conducting an expanded WBDR to more centres with a more comprehensive case     report form, around the world.   "
38872|NCT02776813|"     This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and     efficacy of an autologous T-cell product expressing ACTR in combination with rituximab in     subjects with refractory or relapsed CD20+ B-cell lymphoma.   "
38873|NCT02776800|"     When elderly patients need help caring for wounds, physicians may refer patients to home     health care providers. The home health provider sees the patient in the patient's home and     assists the patient with wound care. Working with the patient's physician, the home health     provider will use the appropriate wound covering (dressing or bandage) to cover the     wound. The goal of the home health provider is to ensure that the wound stays clean and     progresses toward closure. The home health provider will conduct in-home patient visits at     appropriate intervals to assess the status of the wound.      Extensive resources are required to see patients in their own homes. If a dressing could     effectively manage wounds and allow longer time between in-home visits (without affecting     patient safety or progress of the wound toward closure), then resources could be saved. Thus,     newer dressings are designed for longer wear times, using advanced foam pads and adhesives     that help keep the dressing in place. The hypothesis of this study is that the use of Allevyn     Life will decrease the number of in-home visits by home health providers without sacrificing     patient safety.   "
38874|NCT02776787|"     Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last     decade, the use of elective colon resection has increased by more than 50%, and     diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike     have a difficult time deciding if surgery is the best choice to treat diverticulitis. The     goal of the DEBUT study is to improve the understanding about how doctors and patients make     decisions to have elective surgery for diverticulitis, and the global impact of     diverticulitis on patients' lives.   "
38875|NCT02776774|"     There is considerable interest in using in-wound antibiotics (IWA) to prevent infection after     spine surgery. An adequate evaluation of IWA is lacking and prior studies are limited by     confounding and bias. This prospective study will enroll spine surgeons across the country to     complete a survey about their knowledge, attitudes, and practices for using in-wound     antibiotics.   "
38876|NCT02776761|"     This is a single-center, randomized, single-blinded study of the HTNV DNA vaccine alone, PUUV     DNA vaccine alone, and mixed HTNV/PUUV DNA vaccines delivered IM by the needle-free PharmaJet     Stratis DSJI device.   "
38877|NCT02776748|"     The purpose of this study is to quantify the magnitude and extent of infant exposure to daily     emtricitabine (FTC) /tenofovir disoproxil fumarate (TDF) via maternal breastmilk when taken     pre-exposure prophylaxis (PrEP) by lactating HIV-uninfected women. The primary outcome is the     steady state concentrations of emtricitabine and tenofovir in the infant plasma.   "
38880|NCT02776709|"     Cholangioscopy, or direct visualization of the bile ducts was first documented in the late     1970s and has made many advances over the last few decades. The advent of mother-baby scopes     allowed for both diagnostic and therapeutic procedures, though the early scopes were often     fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later     became popular as a method to digitally view the bile ducts, however, often needed guide-wire     or balloon-assistance to allow for cannulation. Other disadvantages of these systems included     limited steerability, and poor irrigation capabilities.      The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a     fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic     purposes in the biliary system. However, image quality was often lacking due to the     fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by     introducing a digital sensor for better image quality, which will allow for better     visualization and diagnosis of indeterminate strictures. Furthermore, modification of the     scope platform allows for efficient use, reliable directionality of the scope tip, and     improved ease of passage of accessories during therapeutic procedures such clearing stones or     stent placement.   "
38881|NCT02776696|"     The purpose of the study is to compare two closed-loop strategies in terms of glycemic     control in Type 1 Diabetes during a camp setting.      The proposed study is a three-segment feasibility study. One segment is a proof of concept     study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms,     cross-over, randomized and single-center and the third segment is four-arms, parallel,     randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on     insulin pump therapy.      Segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses     logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim     to evaluate glucose performance using closed-loop control. Part 2-is a randomized cross-over     (two arms) in-patient study: A total of 12 patients will participate in this part of the     study. Following the run-in period subjects will be randomized to participate in two periods     of closed-loop treatment, each period will last 36 hours in hospital setting. During the     first period, glycemic control will be controlled by the Hybrid closed-loop system and during     the second period by Hybrid Logic closed-loop system. The sequence of treatment first period     HCL therapy than AHCL or vice versa will be randomly assigned.      Segment 2 is a randomized cross-over (two arms) Camp Study including up to 30 patients.     Following the run-in period subjects will be randomized to participate in two periods of     closed-loop treatment, each period will last 2days in a camp setting, the total duration of     the camp will be up to 6 days. In one period, glycemic control will be controlled by the     Hybrid closed-loop system and another period by Hybrid Logic closed-loop system. The sequence     of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.      Segment 3 is a randomized, parallel (four arm) Camp Study including up to 80 patients.     Following the run-in period subjects will be randomized to participate in one of 4     intervention arms of closed-loop treatment in camp settings. The duration of the camp will be     12 days in which glycemic control will be controlled by one of 4 versions of closed-loop     system: Hybrid Closed Loop (HCL) or one of 3 versions of Advanced Hybrid Closed Loop (AHCL).   "
38882|NCT02776683|"     The objective of this trial is to evaluate the safety and tolerability of BI 695502 in     combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy     (when applicable). As well as to evaluate the following efficacy parameters: Progression-free     survival (PFS), objective response rate (proportion of patients with complete response [CR]     plus partial response [PR]), overall survival (OS), duration of response (DOR), time to     progression (TTP).   "
38884|NCT02776657|"     This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood     clots can be identified within the blood vessels supplying blood to the heart in patients     with angina and who have recently suffered a heart attack.   "
38885|NCT02776644|"     The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since     targeted therapy being widely applied. This study will retrospectively analyse the clinical     outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance     Research Database.   "
38886|NCT02776631|"     A prospective randomized study comparing a new implant with three interlocked pins for     internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden)     versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).   "
38887|NCT02776618|"     We will be recruiting patients requiring excisions of skin cancer and comparing aesthetic and     functional differences of suture repair of excisional defects using polyglactin 910 vs     poliglecaprone 25 with a split-scar model. Excision sites will be on either the trunk or     extremities. Standard dermatological excision and repair methods will be used for removal of     lesions and repair of the wound by surgeons; training courses will be used to limit     inter-surgeon variation in technique. Excisional defects will be repaired with deep     polyglactin 910 sutures, followed by randomly assigned subcuticular closure of one half of     the defect with polyglactin 910 sutures and the other half with poliglecaprone 25 sutures.     The patient will follow-up at 6 months and fill out a patient self-assessment evaluation     survey of the scar. Photographs will also be taken of the scars at the follow-up at 6 months,     which will be then be assigned to a set of blinded observers to evaluate the wound using a     modified Patient Observer Self-Assessment Scale (mPOSAS). These observers will rate each scar     on the mPOSAS scale and values will be averaged between observers. Total duration of     participation will be 6 months, with 2 total visits (excision visit and follow-up visit).   "
38888|NCT02776605|"     Evaluate the response (complete hematologic response [CHR], complete cytogenetic response     [CCyR], major molecular response [MMR] and complete molecular response [CMR] of the     combination of ponatinib with standard chemotherapy (according to PETHEMA ALL Ph08 trial) in     young patients with Ph+ (BCR-ABL) ALL.      All patients are treated with:      Pre-phase (maximum 7 days, -7 to -1):      Prednisone 60 mg/m2/day IV over 7 days (-7 a -1) and triple intrathecal therapy (TIT)     (Methotrexate [MTX]: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg). 2. Induction (day 1 to day     28 or up to hematological recovery) Vincristine (VCR): 1.5 mg/m2 (maximum 2 mg) IV days 1, 8,     15 and 22. Daunorubicin (DNR): 45 mg/m2 IV days 1, 8, 15 and 22. Prednisone (PDN): 60     mg/m2/day, IV or PO, days 1 to 27. Ponatinib 30 mg, PO from day 1 to consolidation. TIT, days     1 and 22. 3. Consolidation (day 1 to day 63) Mercaptopurine (MP): 50 mg/m2, PO days 1 to 7,     28 to 35 and 56 to 63. MTX: 1,5 g/m2, IV (24 h continuous infusion) days 1, 28 and 56. VP-16:     100 mg/m2/12 h, IV, days 14 and 42. ARA-C: 1000 mg/m2/12 h, IV, days 14-15 and 42-43. TIT     (MTX: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg), , days 1, 28 and 56. Ponatinib 30 mg/d PO,     from day 1 to 15 days before HSCT. 4. HSCT (performed ideally within 1 month from the end of     consolidation). AlloHSCT preferred over autoHSCT (autoHSCT only indicated if alloHSCT not     feasible). Myeloablative conditioning with cyclophosphamide and total body irradiation (TBI)     whenever possible. 5. Post HSCT therapy After alloHSCT. Frequent monitoring of MRD (every     month). I After autoHSCT: Frequent monitoring of MRD (every month).   "
38889|NCT02776592|"     This study aims to determine if a cow's milk-based formula with added nutrients has an effect     on memory, reaction time, strategy or other cognitive development indicators in children 4-5     years of age.   "
39131|NCT02773446|"     The purpose of this study is to determine the safe and optimal dose and regimen (fasting     duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain.      Additionally, an assessment of homologous protection following rechallenge with B7A will be     assessed.   "
38890|NCT02776579|"     The majority of today's youth do not engage in enough physical activity (PA) to maintain good     health. Low PA levels are associated with poor health (e.g. diabetes, high blood pressure)     and early mortality. Girls are less likely than boys to be active, and their rates of     participation drop off more steeply during adolescence. Girls report many barriers to     exercise, including transportation issues and feeling self-conscious about their appearance     and abilities. School-based PA programs that try to improve health, mainly through aerobic     exercise and education, have had a small effect to date. However, the few programs that     included resistance training as the focus showed strong improvements in health related     measures. In this project, we will examine the effect of a female strength and conditioning     specialist on decreasing barriers and increasing the overall health of high school girls,     with the delivery of in-school, girls-only resistance training programs. We will see if     physical and mental health changes with the training, and how the presence of the S & C     specialist affects the girls' social interactions within the school. The results will help     individuals in the education sector plan programs and services to improve overall youth and     school health.   "
38891|NCT02776566|"     The purpose of this study is to demonstrate the feasibility and effectiveness of     anticoagulation self-monitoring coupled with an educational intervention in a minority     underserved population.   "
38892|NCT02776553|"     The primary aim of this study is to improve both physical fitness and sarcopenia of patients     with ESLD who are potentially eligible for liver transplantation through a 12-week physical     training program. Secondary aims will focus on changes in anthropometrics, body composition,     quality of life, and metabolic profile. This is a randomized clinical trial including 50     patients, with half allocated to the active group (physical training program) and half to     standard of care.   "
38893|NCT02776540|"     Evaluate the role of loading Clopidogrel in acute ischemic stroke in improving neurological     outcome of stroke in cases patients will be non-eligible for, or declined, treatment with or     intravenous thrombolysis with rTPA, rTPA is not available or thrombectomy.   "
38894|NCT02776527|"     The main purpose of this study is to evaluate whether the Apatinib can improve the disease     free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed     postoprative adjuvant chemotherapy. Meanwhile, the investigators also will evaluate whether     the Apatinib can improve the overall survival (OS), estimate the quality of life of patients     have taken the Apatinib and monitor the security of Apatinib.   "
38895|NCT02776514|"     This study investigates clinical outcome and imaging outcome parameters after intraarticular     injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients     with early osteoarthritis of the knee joint.   "
38896|NCT02776501|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
38897|NCT02776488|"     Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as     indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed safety     analysis of glucose and sodium lactate infusions in humans and have demonstrated proof of     concept that these fuels alter brain metabolism. We will conduct a multicenter, adaptive     design-based, proof of concept unblinded phase 2 study of up to 3 candidate supplemental     fuels infused over 3 hours in patients with severe traumatic brain injury undergoing standard     of care multimodality monitoring with cerebral microdialysis.   "
38898|NCT02776475|"     This prospective one group cohort study seeks to investigate the effects of sacral     neuromodulation on urinary urgency, frequency and urge incontinence are maintained after the     simulator device is temporarily turned off for a period of four weeks.   "
38899|NCT02776462|"     The purpose of this study is to determine the sensitivity and specificity of an aid in     assessment of concussion based on eye-tracking, in comparison to a clinical reference     standard appropriate for the Emergency Department (ED).   "
38900|NCT02776449|"     The main aim of this study is to determine the trans-laminal cribrosa pressure difference     (TLCPD) for normal tension glaucoma (NTG) patients from the brain and the eye in supine,     upright and minor head down tilt positions. It is also to investigate the venous drainage     system in the same body positions.   "
38901|NCT02776436|"     The manufacturer recommends two different regimens of prophylactic dexamethasone to prevent     hypersensitivity and fluid retention reactions caused by docetaxel: a 3-day regime of     dexamethasone 8mg twice a day starting the day before chemotherapy for breast cancer and for     prostate cancer 3 times 8mg dexamethasone on the day of docetaxel infusion, given the     concurrent use of prednisone 2dd5mg. There is little evidence that supports this high dose     regimen used nowadays. There is need to re-evaluate this high dosage of dexamethasone for     three main reasons. First, dexamethasone can give side effects such as manifestation of     latent diabetes mellitus, immunosuppression, personality changes, irritability, euphoria, or     mania and mood swings. Second, dexamethasone is an immune suppressor, which might inhibit     chemotherapy-induced apoptosis and compromise the efficacy of chemotherapeutic agents. Third,     dexamethasone is a CYP3A4 inducer, which might increase docetaxel clearance. This study aims     to evaluate the feasibility of reducing prophylactic of dexamethasone around docetaxel     infusion.   "
38902|NCT02776423|"     Transurethral injection using polyacrylamide hydrogel (Bulkamid®, Contura A/S, Denmark) is an     established treatment for stress urinary incontinence. The rates of women reporting     improvement or cure after Bulkamid injection for stress urinary incontinence range between     64-77% with a very low morbidity. However, the indications for use are unclear. Although     transurethral polyacrylamide hydrogel injection is inferior to midurethral slings with regard     to expected cure rates, the procedure is associated with very low rates of adverse events in     general and serious adverse event in particular. As such, it may be an important alternative     for patients where surgery is not considered a safe option either because of co-morbidity or     because of complicated incontinence. The investigators performed a prospective study to     determine the effects of transurethral polyacrylamide hydrogel injection in patients     considered ineligible for midurethral sling surgery.   "
38924|NCT02776137|"     This is a non-randomized, phase II, open label study of postoperative concurrent     chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and     neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of     concurrent chemoradiotherapy with docetaxel in HNSCC patients.   "
38903|NCT02776410|"     The purpose is to investigate young consumers' attitudes and behaviour towards sustainable     and healthy eating by applying a multidisciplinary approach, taking into account economical,     marketing, public health and environmental related issues. In order to achieve this goal,     consumers' reactions on interactive tailored informational messages about sustainable from     social, environmental and economical point of view, as well as healthy eating behaviour in a     group of Polish young adults will be investigated. Main research questions that will be     addressed: What is consumer's current behaviour and perception of sustainable healthy eating?     What are factors determining consumers' reactions to messages about sustainable healthy     eating? What are consumers' reactions on interactive tailored communication about sustainable     and healthy eating behaviour? About 200 Polish consumers will take part in this randomized     controlled trial. A stratified design will be used to recruit 18-30 years old adults using     smart phones. The sample will be represented for gender and region. Participants will be     randomly assigned to either a study or a control group. They will complete a baseline and     follow-up survey. An application for smart phones will be developed by a professional IT     company in order to deliver personalised messages to the participants. Intervention will take     one month. Messages developed following the theory-linked definitions of behaviour change     techniques will be sent to the participants every 2-3 days. The six principles of sustainable     and healthy behaviour introduced in the campaign Livewell 2020 will be used as a base to     communicate to consumers.   "
38904|NCT02776397|"     Relationship of haptoglobin phenotype to vascular function and response to Vitamin E     supplementation in Patients with Diabetes Mellitus Type 2: The EVAS Trial      Specific Aims:      The phenotype haptoglobin 2-2 (Hp 2-2) is associated with higher oxidative stress,     inflammation, LDL peroxidation and higher cardiovascular risk in patients with diabetes. We     aim to determine whether Hp 2-2 phenotype is associated with surrogate markers of     cardiovascular risk, inflammation, lipids and lipoprotein profile, oxidative stress, and     endothelial cell (EC) apoptosis (in vitro study) in patients with diabetes in our population     and whether vitamin E supplementation mitigates this risk.      Methods:      Screening Phase:      We will recruit 300 patients with diabetes mellitus type 2 (100 Chinese, 100 Malays and 100     Indians) and assess their Hp phenotype, surrogate markers of cardiovascular risk,     inflammation, vascular biomarkers and lipids phenotype.      In vitro Study:      Plasma from 20 patients with Hp 2-2 phenotype and 20 patients with non Hp 2-2 phenotype will     be studied in vitro using a haemodynamic lab-on-chip system to determine whether there is a     difference in EC apoptosis between the two groups.      Randomisation Phase 200 patients will be recruited to a pilot randomized controlled trial     (RCT), stratified by Hp 2-2 phenotype status (100 Hp 2-2 and 100 non-Hp 2-2), and randomly     allocated in a 1:1 ratio to either vitamin E 400 IU supplementation daily for 6 months or a     placebo group. The trial will determine whether vitamin E improves the aforementioned     surrogate markers in the Hp phenotype strata.      Importance of proposed research to science and medicine:      This study allows us to understand the possible mechanism of cardiovascular risk in patients     with Hp 2-2 phenotype and to see whether vitamin E supplementation reduces this risk in a     pharmacogenomic targeted manner.   "
38905|NCT02776384|"     The study aims to investigate whether disease progression in patients with chronic heart     failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The     study also intends to describe comparison of echocardiography with cardiopulmonary function     test in CHF patients, and relating these cardiac functional parameters to clinical outcome.   "
38906|NCT02776371|"     Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1),     especially 47-66% in China.   "
38907|NCT02776358|"     Bedside clinical case learning, such for respiratory distress, represent a challenge for     medical teachers, especially in critical conditions. In fact, this kind of learning implicate     the presence of an appropriate case (the patient itself), framework and may be time consuming     which could compromise the patient's safety and wellbeing.      New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of     knowledge. in recent years, the development of medical simulation has found a growing     interest in the medical teaching field. Contextualization, reproducibility and reliability     are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime     experience of clinical conditions without putting at risk patient's safety and comfort.      The aim of this study is to assess the impact of HFS on fifth year medical students learning     skills in the assessement and management of an acute asthma attack in the emergency room, and     to compares it to other modern teaching tools such as video-case   "
38908|NCT02776345|"     The purpose of this study is to determine whether minimally invasive treatments like     ultrasound guided needle fragmentation with and without lavage is associated with better     clinical outcomes compared to the subacromial bursal corticosteroid injection treatment only.   "
38909|NCT02776332|"     The purpose of this study is to determine how the duration of manual expression affects milk     volumes and levels of breastfeeding self-efficacy in mothers of premature infants.      The specific aims of this study are to determine if the duration of manual expression in     mothers of premature infants will result in: (a) an increase in breastfeeding self-efficacy     (b) a difference in milk volume and (c) a correlation between breastfeeding self-efficacy and     milk volume.   "
38910|NCT02776319|"     The objective of the study is to determine the effect of non-invasive brain stimulation on     craving for tobacco and brain metabolites.   "
38911|NCT02776306|"     The purpose of this study is to evaluate the effects of mirror box therapy on upper     extremity, motor recovery and motor functioning in patients that have suffered a stroke.   "
38912|NCT02776293|"     Prenatal anxiety and depression are distressing for the expectant mother and can have adverse     effects on her fetus and child. This study aimed to determine whether listening to specially     composed songs would be an effective intervention for reducing symptoms of prenatal anxiety     and depression over a period of 12 weeks.   "
38934|NCT02776007|"     The Libre- flash glucose monitoring system is an episodic real-time data on demand device.     This means that patients can measure their glucose level when they choose by scanning the     device, while at the same time a sensor automatically measures and continuously stores     glucose readings day and night. Every scan shows the current glucose reading and the last 8     hours of glucose. There are no alarms and the system does not require calibration.      In the present study we aim to evaluate treatment satisfaction and comfort using the Libre     flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose     (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose     monitoring.      The second aim of the study is to evaluate the rate of use and the impact of Libre use     compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally     controlled and stopped using Continuous Glucose Monitoring. The study is an investigator     initiated study, single-center, randomized, parallel study of 12 weeks with an optional     cross-over 12 weeks extension period .   "
48091|NCT02656147|"     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric     Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed     CD19+ haematological malignancies.   "
38913|NCT02776280|"     This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and     solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared     with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian meals     (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or     non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of     food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion,     unstimulated saliva and dental biofilm will be collected for determination of fluoride     concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of     mastication) will be collected for determination of fluoride concentration. Dental biofilm     will be collected immediately after the ingestion of the meal. Saliva will then be collected     after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an     ion-specific electrode. In order to standardize biofilm formation, during lead-in and     wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2.     refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew     sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each     phase. Groups will be compared by ANOVA and Tukey test.   "
38914|NCT02776267|"     The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory     efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular,     Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).   "
38915|NCT02776254|"     This study seeks to create generalizable knowledge about the implementation process as well     as the effectiveness and efficiency of a differentiated care system, by measuring patient     health outcomes and implementation outcomes such as acceptability, feasibility, fidelity, and     costs   "
38916|NCT02776241|"     The objective of this study is to measure the influence of both short term water restriction     and high water intake on total kidney volume, measured by Magnetic Resonance Imaging (MRI)     scan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients.   "
38917|NCT02776228|"     The study deals with the prevalence of insomnia after heart surgery and the outcome of     treatment with Benzodiazepine for this phenomena.   "
38918|NCT02776215|"     Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children     and Adolescents.   "
38919|NCT02776202|"     Sickle cell disease (SCD) is the most common inherited blood disorder in Saudi Arabia . Its     clinical severity is widely heterogeneous among patients who share the same genetic mutation     . Severe frequent pain crisis, recurrent acute chest syndrome and stroke are features of     severe SCD. Hydroxyurea is an effective treatment of SCD as it ameliorates the severity and     frequency of pain crisis and acute chest syndrome and decreases mortality, however, it is     less effective in the prevention and treatment of stroke and other end organ dysfunctions .     The only readily available cure of SCD is by hematopoietic stem cell transplantation (HSCT) .     Most children with SCD who are treated by HSCT receive myeloablative conditioning with     excellent results. The application of reduced intensity (RIC) and non-myeloablative (NMA)     conditioning regimens are reserved for patients older than 16 years of age because of the     increased risks of morbidity and mortality after HSCT6. However, infertility and gonadal     failure after myeloablative conditioning are important barriers to the willingness of     patients and their families to undergo HSCT . The development of an effective RIC HSCT in SCD     that might spare the fertility of SCD patients would have obvious merit.      With the ultimate goal of expanding this curative therapy to SCD patients, we propose to     investigate HSCT with a RIC conditioning regimen. We will carry out a pilot study of HSCT     from HLA matched sibling donors using thymoglobulin/fludarabine/melphalan conditioning and     sirolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis in SCD patients with severe     complications such as stroke and other severe complications. We hypothesize that HSCT from     HLA matched sibling using thymoglobulin/fludarabine/melphalan conditioning in SCD will     maintain a level of stable donor chimerism that is sufficient to cure SCD with minimal     toxicity.   "
38920|NCT02776189|"     MRI though not painful requires deep sedation for children due to the loud noise created.     With deep sedation comes respiratory depression so the interest in Dexmedetomidine. For     standardization MRI brain was chosen and also for the fact that patients usually have history     of convulsions where drugs like ketamine may not be a good option. Patients were recruited     after ethics committee approval. After pre-medication with intranasal midazolam 0.2 mg/kg     body weight, Intravenous access was established and then patients were divided in two groups.     One group received intravenous propofol 2mg/Kg and infusion of 100mcg/per kg body weight per     minute. The other group received intravenous bolus of Dexmedetomidine 1mcg/kg over 10 minutes     and then a infusion of Dexmedetomidine 1mcg/kg/hour.      Primary out come was to study the recovery time of patients sedated with Dexmedetomidine     compared to patients sedated with propofol for paediatric MRI brain. Secondary outcome were     analysed in terms of time for induction,procedural disruptions due to awakening and     haemodynamic stability . Follow up was done on phone for any adverse events.   "
38921|NCT02776176|"     The study is designed to determine if enhanced recovery after surgery (ERAS) principles could     provide benefit for pediatric patients undergoing radical surgery for Hirschsprung's Disease     (HD). Half of patients will receive the ERAS program, while the other half will receive the     traditional program.   "
38922|NCT02776163|"     This is a non-randomized, phase II, open label study of postoperative current     chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary     purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy     in these patients.   "
38923|NCT02776150|"     Background:      Drug resistant tuberculosis is a serious public health problem that threatens the health of     human life and the development of society and economy. At present, the diagnosis of     drug-resistant tuberculosis mainly depends on traditional drug susceptibility test. But it is     limited in Mycobacterium tuberculosis slow growth speed, traditional solid drug sensitivity     test usually need to 3 months to results, delay the development of drug resistance in     patients with effective treatment. Probe melting curves resistance detection technology is     the recent emergence of a new molecular biology and drug resistant tuberculosis detection     technology, probe melting curves with different fluorescent labeled probe coverage detection     specific to M.tuberculosis drug resistance determining region, through changes in the melting     point of the probe hybridization, acquire mutation information of detection region, shorten     detection time and detect nonuniform resistance.      In this study, by selecting a nationally representative in different levels of hospitals     jointly launched multi center, large sample clinical assessment, completed the comprehensive     evaluation of sensitivity, specificity and health economics of drug resistant pulmonary     tuberculosis, especially resistance to multidrug and extensively drug-resistant TB patients     detection,in order to evaluate the rapid, accurate and economic and appropriate technology of     drug resistance pulmonary tuberculosis detection.      In order to accomplish the overall goal of the project, in the framework of the overall     design, according to the principles of the core tasks are divided into four sub topics,     namely:      Sub topic 1 of the core mission is included in 3100 cases of smear positive pulmonary TB     suspicious symptoms, from which selected more than 1000 cases of drug-resistant pulmonary     tuberculosis patients, using MGIT liquid culture and drug sensitivity test as the gold     standard,evaluate the sensitivity and specificity of probe melting curves in detction of     resistance of four kinds of anti tuberculosis drug to Mycobacterium tuberculosis; Sub topic 2     core task is including at least 500 cases of culture positive pulmonary tuberculosis patients     and treatment follow-up, using MGIT liquid culture and drug sensitivity test as the gold     standard, evaluate the application value of probe melting curves for monitoring spectrum     changes of drug resistance of Mycobacterium tuberculosis during pulmonary tuberculosis     treatment.      The core mission of sub topic 3 is to project implementation of hospital as the research     site,acquire the cost-effect evaluation and analysis by comparing probe melting technology     with Mycobacterium tuberculosis MGIT liquid culture, and drug sensitivity test with xpert     MTB/RIF technology.   "
38925|NCT02776124|"     Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients     undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other     treatment-related problems. Malnutrition is associated with lower physical functioning, lower     immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption     of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired     quality of life (QoL), and increased mortality. Although the international guidelines     recommend early nutritional support in the presence of nutritional risk, the best type of     nutritional intervention is still unclear. Individualized dietary counseling showed     beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer     patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most     acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck     cancer patients have been conducted on small samples and did not clarify the role of oral     nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A     the use of ONS associated with dietary counseling for head-neck cancer patients undergoing     RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately     sized and randomized clinical trials for Chinese NPC patients.   "
38926|NCT02776111|"     The field of genomics is an exciting new field being applied in medicine. Its use in treating     some cancers, sepsis and burn patients has been very promising. As knowledge of genomics and     application of microarrays expands, researchers are developing more intelligent ways to     provide individualized care for patients. The plan of this research study is to apply the use     of genomics as a tool for transplant in several capacities.      This research study is designed to develop methods of isolating relevant cell types via     microarray plates, then extracting mRNA samples of those cell types and capturing their     genetic profile. This will be done with the blood of five healthy donors. Once this ability     has been demonstrated, the next step will be to use these testing in several capacities in     transplant patients. The research study plan involves following the genetic profile of 26     kidney transplant patients. One group will be followed prospectively starting at baseline,     and then at various set time points. A second group will be sampled with the occurrence of     clinical events. These events include viral, bacterial, and fungal infection, WBC < 2.5 or     biopsy proven rejection episodes or normal graft function. Thus, the intention of the study     is to demonstrate how immunosuppression alters the expression of this genetic expression of     these T cells. In doing so, the study will provide a better understanding of the specific and     true immunosuppressed state for any given patient.   "
38927|NCT02776098|"     This study will investigate the link between glucose abnormalities and elements critical to     muscle function including mass, composition and energy metabolism. the primary goal of the     study is to determine whether Cystic Fibrosis (CF) disease is associated with muscle     dysfunction, especially in the presence of glucose intolerance. This is a longitudinal cohort     study of 3 main groups: CF subjects without Cystic Fibrosis-related diabetes (CFRD), healthy     matched controls and CF subjects with newly diagnosed CFRD started on insulin therapy.   "
38928|NCT02776085|"     Bedside ultrasound in the emergency department is useful for quick assessments of patients.     One growing use is to measure the optic nerve sheath diameter of patients for whom increased     pressure in the head is a concern. This study will look at the optic nerve sheath diameters     of a specific population of pediatric patients with shunts that drain extra fluid from their     heads.   "
38929|NCT02776072|"     The primary objective of the study is to evaluate the real-world clinical effectiveness, as     measured by the proportion of participants relapsed at 12 months, in participants treated     with dimethyl fumarate (DMF).      Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as     measured by the proportion of participants relapsed at 12 months, in participants treated     with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall     participant cohort and in a subset of participants who were naïve to disease-modifying     therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the     index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among     participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related     hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To     compare intravenous corticosteroid use among participants treated with DMF, GA,     teriflunomide, or fingolimod.   "
38930|NCT02776059|"     This is a multi-center, prospective, randomized trial of standard of care vs. standard of     care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic     hepatitis and DF≥32.   "
38931|NCT02776046|"     The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a     perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.   "
38932|NCT02776033|"     This is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase     inhibitor, in subjects with active plaque-type psoriasis.      The primary objective will be to investigate the safety and tolerability of repeat oral doses     of GSK2982772 (60 mg twice daily for 84 days). In addition a number of experimental and     clinical endpoints will be employed to obtain information on the pharmacokinetics,     pharmacodynamics, and efficacy in subjects with active plaque-type psoriasis (PsO).      After a screening period of up to 30 days, approximately 30 subjects will be randomized to     receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a follow-up period     (28 days). The total duration of this study is approximately 20 weeks from screening to the     last study visit.   "
38933|NCT02776020|"     The aim of this study is to determine efficacy of the CorrecDose device to continuously and     non-invasively follow the changes in propofol concentrations in the participants' blood.   "
38946|NCT02775851|"     This pilot phase II trial studies how well pembrolizumab works in treating patients with     desmoplastic melanoma (DM) that can or cannot be removed by surgery. Monoclonal antibodies,     like pembrolizumab, may block specific proteins which may strengthen the immune system and     control tumor growth.   "
38947|NCT02775838|"     Aim of this clinical study is to establish a novel technique, the so called intraoperative     fluorescence angiography, for kidney graft perfusion visualization during the transplant     procedure.   "
46748|NCT02673736|"     The purpose of this research study is to evaluate safety, pharmacokinetics and preliminary     efficacy of the investigational drug PLX73086 in subjects with solid tumors including     subjects with locally advanced or refractory tenosynovial giant cell tumor (TGCT).   "
38935|NCT02775994|"     Periodic Fever, Aphthous stomatitis, Pharyngitis and cervical Adenitis (PFAPA) is one of the     most common, least explored periodic fever syndrome in childhood. This study aims to     investigate whether a single dose of an interleukin beta (IL-1) antagonist, Canakinumab will     be able to abort PFAPA flares in patients who experience a flare in an average of 2 weeks or     less. This will be a single arm open label pilot study. 10 patients will be recruited from 1     center (Pediatric rheumatology unit -Schneider children's medical center of Israel).      Patients in ages 2-10 years old who are diagnosed with PFAPA according to clinical criteria     at least 3 months prior to enrollment and who are under regular care for this disease (single     dose of glucocorticoids during flare) and who suffer from more than 4 PFAPA flares for the     last 2 months, will be screened for this study. In the second documented flare, patients will     be enrolled to receive a single dose of subcutaneous (SC) Canakinumab 4 mg/kg. The primary     outcome is defined as - 50% reduction in PFAPA flares for the next 2 consecutive months as     reported by the patient (use of diary) and documented by the patient primary care physician     and/ or the researcher in a monthly follow up visits. Secondary outcome measure are define as     time to flare (days) and Parent/patient quality of life assessment measured by 100mm visual     analog scale (VAS).   "
38936|NCT02775981|"     The primary objective of this study is to evaluate the potential effect of hepatic impairment     on the systemic pharmacokinetics of RX0041-002 following single dose intranasal     administration. The secondary objective is to evaluate the safety and tolerability of     intranasal RX0041-002 in subjects with normal hepatic function and hepatic impairment.   "
38937|NCT02775968|"     This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is     different from adults. Cephalosporins and macrolide antibiotics are the common drugs for     children with community acquired pneumonia, the investigators aim to study the population     pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug     for treatment of community acquired pneumonia, and to correlate it with treatment     effectiveness and incidence of adverse effects.      Potential Impact: This novel knowledge will allow better and more rational approaches to the     treatment of community acquired pneumonia. It will also set the foundation for further     studies that will be able to test improved therapies that may increase treatment response in     vulnerable children.   "
38938|NCT02775955|"     The primary objective of this study is to evaluate the potential effect of renal impairment     on the systemic pharmacokinetics of acute Intranasal RX0041-002. The secondary objective is     to evaluate the safety and tolerability of acute Intranasal RX0041-002 in subjects with     normal renal function and severe renal impairment.   "
38939|NCT02775942|"     A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC-     POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in     Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two     hundred and forty children are enrolled and placed randomly into 4 groups (60     children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval.     Safety issues included immediate reaction at the site of injection and systemic reaction     within 30 min of administration, within 7 days after each dose, unexpected event occur within     30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count,     urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising antibodies for     each of vaccine serotypes.   "
38940|NCT02775929|"     The purpose of this protocol is to determine user preferences for antiretroviral therapy     (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected     partners and to optimize targeted delivery and sustained use of these interventions.   "
38941|NCT02775916|"     This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary     therapeutic efficacy of oral administrations of CDZ173, a selective PI3K Delta inhibitor, for     12 weeks, in patients with primary Sjögren's syndrome. Data from this study will provide     basis for further development of the compound for the treatment of primary Sjögren's     syndrome.   "
38942|NCT02775903|"     This is a Phase 2, multicenter, randomized, parallel-group, open-label study consisting of 3     phases: Screening, Treatment, and Follow-up.      To confirm the safety, ie, the absence of overlapping toxicities of the combination treatment     regimen, an early safety monitoring will be performed based on approximately the first 12     subjects randomized.      A total of approximately 72 subjects will be included in the Myelodysplastic syndromes (MDS)     cohort and approximately 110 subjects in the Acute Myeloid Leukemia (AML) cohort.   "
38943|NCT02775890|"     This is a clinical research protocol to determine the feasibility of assessing lead levels in     hunters who use lead projectiles. This study will determine if it is possible to perform an     interventional double-blind placebo-controlled study of lead levels in hunters using lead or     lead-free projectiles following consumption of self-harvested wild game. The hypothesis for     the subsequent study is that minute lead particles from shrapnel dispersed through the animal     during harvest are ingested and result in increased lead serum levels. This current     observational study establishes if this conclusive interventional study is possible through     establishing if hunters using lead projectiles in New Zealand have elevated lead levels after     eating animals harvested with lead projectiles. This study will be conducted in compliance     with the protocol, Good Clinical Practice Standards, associated regulations and institutional     research requirements.      This study aims to assess if hunters eating meat shot with lead projectiles experience     elevated lead levels. Hunters will be asked to provide blood samples 2-4 days after they eat     meat harvested with lead bullets and provide a subsequent sample when they have abstained     from eating wild game harvested with lead bullets. We have chosen to use deer as the species     for this study to reduce variation and New Zealand is the ideal place to conduct this study     because of year-round hunting of deer. This design will allows paired testing of subject lead     levels.   "
38944|NCT02775877|"     The purpose of this study is to study the effects of letrozole and sequential clomiphene in     ovulation and pregnancy in PCOS patients.   "
38945|NCT02775864|"     The study is a retrospective cohort study of adults with schizophrenia that will compare     outcomes of new users of alternative psychotropic medication strategies using 10 years of     Medicaid data. The primary comparative effectiveness analyses will focus on subgroups of     patients with schizophrenia facing common clinical situations.   "
38948|NCT02775825|"     End-of life care is one of the principle components of cancer care. Measurement of the     quality of care provided for end-of-life cancer patients is an important issue. Recently     there has been an increased emphasis on measuring and monitoring the quality of cancer care     for the purpose of improving clinical practice. Despite increasing attention paid to     end-of-life care in recent years, many studies have described difficulties in the final phase     of life, including problems with access to hospice, inadequate symptom management, care     giving burdens, care mismatched with patient preferences, and inappropriate resource use.     Measuring quality of life is an important issue for monitoring clinical practice and     improving outcome. Although patient assessment is the best quality measure, it is impractical     to measure the quality of end-of-life care because of the difficulties of accurate     prognostication for end-of-life and many patients are too ill to provide assessments. In     contrast, several recent studies developed quality indicators (QIs) of palliative and     end-of-life care, which assess the quality from existing sources such as administrative data     or medical chart data.   "
38949|NCT02775812|"     This phase I trial studies the side effects and best dose of pembrolizumab when given     together with cisplatin and intensity-modulated radiation therapy, in treating patients with     stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs     used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells     and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation     therapy may work better in treating patients with squamous cell carcinoma of the head and     neck.   "
38950|NCT02775799|"     Registration of all sarcoma patients treated at a specialized sarcoma center in Switzerland.   "
38951|NCT02775786|"     This is a prospective cohort study in participants with pancreatic adenocarcinoma who are     undergoing surgical resection. Participants will have up to two magnetic resonance imaging     (MRI) scans with and without intravenous contrast. The MRI will be performed using either an     extracellular contrast agent or using a macromolecular contrast agent. These contrast agents     are routinely used in body MRI and are on formulary at this institution. Parameters will be     compared to histopathology measures of mean vascular density and grade of fibrosis,     respectively. The purpose is to establish a standard protocol for future clinical trials of     treatments that would use MRI parameters as quantitative markers of treatment effect.   "
38952|NCT02775773|"     The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral,     is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum     period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum     hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal     delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called primary when     blood loss arose within 24 hours after birth.   "
38953|NCT02775760|"     The overall goal of this study is to examine how regular exercise affects brain function,     spatial memory, and virtual navigation. Participation in this research study will take     approximately 4 months.   "
38954|NCT02775747|"     There is limited application of the use of PRP in obstetrics, therefore there is a need for     assessment if it is efficacy in improving skin wound healing in cesarean section.   "
38955|NCT02775734|"     This prospective randomized placebo-controlled double blind clinical trial will conducted in     Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate     resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be     randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200     mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or     clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical     pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live     birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation,     mid- luteal sub-endometrial blood flow indices, and incidence of side effects.   "
38956|NCT02775721|"     Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for     head and neck cancer. Inadequate dietary intake is multi factorial, with patients     experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard     practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related to     Head and Neck cancer treatment.   "
38957|NCT02775708|"     The purpose of this study is to support development of PillCam Endoscopy System applications.   "
38958|NCT02775695|"     This is a window-of-opportunity study that examines the efficacy of doxycycline, and     FDA-approved oral antibiotic, on metakaryotic (cancer stem cells) in resectable pancreatic     cancer following eight weeks of treatment.   "
38959|NCT02775682|"     The purpose of this study is to determine whether patients with epilepsy exhibiting impaired     dCA, which may contribute to subsequent stroke.   "
38960|NCT02775669|"     Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which     underwent an operation due to craniosynostosis.   "
38961|NCT02775656|"     The purpose of this observational follow-up study is to collect data systematically on     pregnancies and offspring of women who become pregnant while participating in a Certolizumab     Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential     CZP exposure during pregnancy.   "
38962|NCT02775643|"     This is an observational, non-therapeutic study to collect clinical and molecular information     of pediatric patients with childhood melanocytic lesions.      PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from     paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions     (including melanoma, spitzoid melanoma, congenital melanoma, melanoma arising in giant nevi).      SECONDARY OBJECTIVE: To collect minimal information on patients treated with adjuvant or     systemic therapies according to National Comprehensive Cancer Network (NCCN) guidelines.   "
38973|NCT02775500|"     The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned     pregnancies exposed to apremilast and to evaluate the safety of this medication relative to     specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast     exposure on infant health status through one year of age.   "
38963|NCT02775630|"     Bronchoscopy is an examination performed routinely in pulmonology. This exam is considered as     uncomfortable by nearly 60% of patients, especially due to respiratory blocking sensation,     cough and nausea it causes, despite the use of a local anesthetic. Conversely, this     examination is rarely performed under general anesthesia in hospitals in France, because it     lengthens the duration of the procedure, increases its cost and can be dangerous for the     respiratory failure patient.      Hypnosis is an altered state of consciousness between wakefulness and sleep, which can cause     the patient to ignore the reality in which he is focusing his attention on his imagination,     reducing his anxiety, his painful or unpleasant perceptions and their memorization.      The hypnosis benefit has already been evaluated in the control of pain and anxiety in many     medical situations, surgical, obstetric and dental. In endoscopy, the results are mixed. In     bronchoscopy, hypnosis has, to our knowledge, not been evaluated.      In a preliminary study in the endoscopy unit of the Hospital Saint Joseph, involving 66     patients, investigators showed that bronchoscopy was poorly tolerated in more than half of     patients and that this poor tolerance was correlated to the level anxiety of patients, but     75% of patients surveyed would prefer the waning redo the examination in the same conditions     if their health required it, rather than using a general anesthetic. Investigators then     hypothesized that hypnosis would improve tolerance bronchoscopy under local anesthesia,     without the need for general anesthesia.   "
38964|NCT02775617|"     This is an open-label prospective community intervention trial to assess the impact of     community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws     bacterial skin infections.      Communities will be randomised to receive standard treatment for both yaws and scabies either     in parallel (site 1) or in sequence (site 2).      Treatment of yaws:      Single dose of Azithromycin (30mg/kg, max 2G).      Treatment of scabies:      Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a     contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses     7-14 days apart.      Investigators will complete a clinical and microbiological assessment of bacterial skin     disease at baseline and at 12 months to assess the impact of treatment on the prevalence of     bacterial infection and the emergence of antimicrobial resistance.      Primary Outcome        1. Difference in the change in prevalence of impetigo between baseline and 12- months          between the parallel and the sequential treatment arms.           Secondary Outcomes        2. Change in the proportion of swab samples from which S. pyogenes is cultured between          baseline and follow-up in the two arms        3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured          in the two arms   "
38965|NCT02775604|"     The purpose of this study is to assess the feasibility and potential impact of video analysis     of footage taken with a GoPro camera video in comparison to a homeowner checklist or gold     standard home assessment as a means of detecting home fall hazards.      Investigators hypothesize that the assessment of homes for fall hazards with a GoPro camera     will be better than a homeowner paper checklist in hazard identification.   "
38966|NCT02775591|"     The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe     for the treatment on health-related quality of life in Parkinson's disease (PD) patients with     gastrointestinal symptoms.   "
38967|NCT02775578|"     As the end stage of almost all cardiovascular diseases, heart failure has become an     increasingly common cause of cardiovascular morbidity and mortality worldwide. In China,     coronary artery disease (CAD) has become the main cause of heart failure in recent years. CAD     combining with heart failure usually predicts poor outcome, with coronary revascularization     the most universally used therapy. However, the difference of several types of such therapy     has less well been compared.      Thus, the study mainly aims to compare different types of coronary revascularization     therapies such as Percutaneous Coronary Intervention (PCI),Coronary Artery Bypass Grafting     (CABG) as well as Hybrid Coronary Revascularization (HCR), and also make the optimization     strategy especially in patients with heart failure.      The study also aims to investigate whether disease progression in patients with chronic heart     failure (CHF) can be assessed by new biomarkers and determine their diagnostic and prognostic     value, relating several cardiac functional parameters to clinical outcome.   "
38968|NCT02775565|"     This is a retrospective, record-based study of approximately 100 patients across up to 12     centers within the United States. All patients who have been treated with the AngioVac Venous     Drainage Cannula and the Extracorporeal Circuit will be considered for study participation.     Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria     to be considered enrolled in the study. The purpose of the study is to describe initial     experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.   "
38969|NCT02775552|"     Alive & Thrive is an initiative that aims to scale up nutrition to save lives, prevent     illness, and ensure healthy growth and development through improved infant young child     feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive & Thrive     intervention package, consisting of interpersonal communication, community mobilization     activities, and radio campaign, can increase complementary feeding practices (minimum dietary     diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among     children less than two years of age. The impact evaluation uses a cluster-randomized design     where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10     intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline     surveys will be used to assess program impact.   "
38970|NCT02775539|"     The purpose of this study is to evaluate the efficacy and safety of mirabegron (a B3     adrenergic receptor agonist) in patients with pulmonary hypertension secondary to heart     failure by conducting a randomized multicenter phase II placebo-controlled clinical trial.   "
38971|NCT02775526|"     This prospective interventional randomized controlled trial will recruit women with MUI     scheduled for surgical treatment where patients will be randomized to either Burch     colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2     years. The primary outcome measures will be the objective and subjective cure rates.   "
38972|NCT02775513|"     Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS)     due to a prolonged cardiac repolarisation phase. Hypoteses: patients with loss-of-function     mutations also exhibit altered hormone release upon glucose ingestion.   "
38974|NCT02775487|"     Primary objective of this project is to measure the impact of passive control and active     control systems on indoor pollution that is directly or indirectly related to ambient air     pollution (smog). The first goal will be to measure baseline parameters for 50 homes,     including information about the building, ventilation characteristics, pollution levels     (indoors and outdoors), and occupant survey information. In a subset of these homes, either     passive or active control systems will be installed and the impact of these systems on indoor     concentrations. Participants will be enrolled on a rolling basis (5-15 persons studied at a     given point in time) over a 16-month period. Participants will be followed for approximately     5 weeks and data obtained at three points in time: at enrollment (day 1 of study), after 1     week (baseline verification) and after four weeks with the control system in the home (at the     end of study week 5).   "
38975|NCT02775474|"     The recent increase in obesity has led to an increase in the need for bariatric surgery. In     this group of patients the postoperative pain management is of vital importance. One strategy     to improve postoperative analgesia is the use of intraoperative methadone, specially in those     patients which regional anesthesia is not feasible. There is evidence that the use of     intraoperative methadone can lead to a analgesia lasting 24 to 36 hours, while not associated     with increased side effects when compared to other opioids with short or intermediate     duration of action. In this study the investigators will evaluate the efficacy of     intraoperative methadone in reducing postoperative pain and opioid consumption.   "
38976|NCT02775461|"     The purpose of this study is to establish a registry of patients with pancreatic diseases.     Patients included in the registry may include those with: pancreatic cancer, precancerous     lesions of the pancreas, inflammatory lesions of the pancreas, cystic lesions of the     pancreas, and patients at high-risk of pancreatic cancer such as those with a family history     of pancreatic cancer or with a family history of a syndrome known to be associated with     pancreatic cancer. Pancreatic cancer is the fourth leading cause of death from cancer in the     United States. However, little is known about the development of pancreatic cancer and     pancreatic diseases in individuals with the above conditions. Knowledge of how family     history, environmental exposures, and inflammatory lesion of the pancreas contribute to the     development of pancreatic cancer and pancreatic diseases is essential.      You may qualify to take part in this research study because you have inflammation in the     pancreas, a pancreatic cyst, pre-cancerous lesions of the pancreas, pancreatic cancer, a     family history of pancreatic cancer, or a family history of a syndrome known to be associated     with pancreatic cancer.      We will also be collecting a blood sample from all participants for DNA isolation. Sometimes     we are born with genes or DNA that give us an increased or decreased chance of developing an     illness later in life. Genetic material will be isolated from your blood for further study.     You may also choose to provide additional blood samples for serum and plasma extraction.     Serum and plasma are components of the blood which can be used to measure indicators of     disease in the blood, called biomarkers,for pancreatic diseases. Clinical data and biological     specimens contained in this study may be used for a wide variety of future related studies to     the cause, diagnosis, outcome and treatment of pancreatic cancer.      Funds for conducting this research are provided by Mount Sinai.   "
38977|NCT02775448|"     Metabolic disorders including hypercholesterolemia and hypertriglyceridemia are present in     climacteric women. Carduus marianus is a homeopathic medicine that traditionally has been     used for hepatic diseases. It has been used for reducing hypercholesterolemia and     hypertriglyceridemia also. The aim of this study is to investigate the most effective dose of     Carduus marianus in centesimal scale (6cH, 12cH, 30cH, placebo) plus diet and exercise for     reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.   "
38979|NCT02775422|"     Comparison of the sensibility and specificity of 3 different serological tests and evaluation     of chicken pox immunity in pregnant women.      Secondary goals :        -  Correlation memory / Immunity;        -  Prevalence of VZV immunity in pregnant women;        -  Evaluation of cellular and humoral immunity in cases with discrepancy between tests or          between test and memory;        -  Evaluation of acceptability of vaccination in the post partum period in non immune          patients.      Methods Not randomized prospective study,      Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years     old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +,     grafted patients   "
38980|NCT02775409|"     This study is for women scheduled to have immediate breast reconstruction following     mastectomy using a tissue expander. The primary purpose of this study is to learn whether     there are differences in the outcome between placing the tissue expander above the muscle or     below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with     reconstruction. A secondary purpose is to learn whether there are differences in     complications and costs between the two locations.   "
38981|NCT02775396|"     With the increasing reliance on tablet computers and smartphones in daily life, it is     important to determine whether and how the prolonged usage of these handheld digital devices     influences the working habits and refractive status. This study aimed to determine the     effects of wearing conventional single-vision lenses vs. new progressive addition lenses on     the working distance and refractive status while playing interactive video game in Chinese     pre-presbyopic adult computer users.   "
38982|NCT02775383|"     Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic     syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap     disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be     followed long term. Clinical data, blood, and tissue samples will be collected to establish a     biorepository to facilitate the study of the natural history of MDS.   "
38983|NCT02775370|"     This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with     Head and neck recurrent/metastatic adenoid cystic carcinoma (ACC). The primary purpose of     this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.   "
38984|NCT02775357|"     The study is aimed at testing whether use of a new index to measure risk for HIV in the     context of HIV testing and counseling will increase demand for safe male circumcision (SMC)     services among HIV-negative non-muslim men in Rakai. We will also study whether use of the     index leads to positive sexual behavioral modifications among men. The study will also     measure acceptability of the index among men.   "
39268|NCT02771652|"     In this randomised controlled trial, the feasibility and effectiveness of an internet-based     exercise intervention including progressive strength and endurance training (e-training) for     PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes     were muscle strength, aerobic capacity and lung function, physical activity and fatigue.   "
39047|NCT02774538|"     Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and     they are associated with genital and oral diseases.      Agreement between cervical and oral HPV infection has been described from a small group of     patient. Our study, performed on a greater number of patients, will provide a good estimation     of this link, between cervical and oral infection, in a French population of women with a     primary cervical HPV infection.   "
38985|NCT02775344|"     This is a prospective randomized study involving 124 patients. All participates will be given     written information on 3D laparoscopy. They will be randomized according to     computer-generated random sequence into two groups, 2D and 3D group. The operation will then     be performed either using 2D or 3D laparoscopy. Surgeons are allowed to change to the other     type of laparoscopy if difficulty encountered. After the operation, the surgeons will be     required to fill in a questionnaire self-evaluating the performance using Global rating scale     component of the intraoperative assessment tool (GOALS), any discomfort encountered, any need     for change of laparoscopy and their preference on the type of laparoscopy.      The level of complexity of the operation, duration of operation, blood loss and complications     will be recorded.   "
38986|NCT02775331|"     This study aims to investigate whether use of interactive worktime planning tools that     support work-time control (possibilities to influence individual shift rosters i.e.     self-rostering) and guide for health-supporting shift ergonomics will improve health and     well-being among shift workers. Effects of the worktime planning tools will be studied in a     quasi-experimental design in the Finnish public sector. Health and well-being at baseline     (2012-2015), will be compared to follow-up data in 2016-2017 based on questionnaire and     pay-roll based objective working hour and sickness absence data among those who a) use an     interactive self-rostering software with a shift ergonomics sub-tool, b) whose working hours     are designed with a non-interactive shift planning software with the shift ergonomics     sub-tool and c) whose working hours are designed with a non-interactive shift planning     software without the shift ergonomics sub-tool.   "
38987|NCT02775318|"     The present study has been designed to assess the efficacy and safety of Stellate Ganglion     Block (SGB) in relieving symptomatic cerebral vasospasm following aneurysmal clipping. The     effect was assessed by both Digital Subtraction Angiography(DSA) and Transcranial Doppler     (TCD).   "
38988|NCT02775305|"     Frailty is a syndrome characterized by decreased reserve and diminished resistance to     stressors. The proposed research will evaluate the association of frailty with chronic kidney     disease (CKD). The prevalence of frailty increases with age and with CKD, but studies are     needed to determine whether frailty is associated with worsening of CKD and whether     intervention to treat frailty can improve physical functioning and health-related quality of     life (HRQOL) as well as slow progression of CKD.   "
38989|NCT02775292|"     This phase I trial studies the side effects and the best dose of nivolumab when given     together with gene-modified T cells and vaccine therapy in treating patients with solid     tumors that express the cancer-testes antigen NY-ESO-1 gene AND have spread from where it     started to nearby tissue or lymph nodes (locally advanced) or distant organs (stage IV). T     cells are a special type of white blood cells (immune cell) that have the ability to kill     cancer cells. Nivolumab may block PD-1 which is found on T cells and help the immune system     kill cancer cells. Placing a modified gene for the NY-ESO-1 T cell receptor (TCR) into the     patients' T cells in the laboratory and then giving them back to the patient may help the     body build an immune response to kill tumor cells that express NY-ESO-1. Dendritic cells are     another type of blood cell that can teach other cells in the body to look for cancer cells     and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic     cells teach the immune system to target cancer cells expressing that protein, and further     help the T cells attack cancer. Giving nivolumab together with gene-modified T-cells and     dendritic cell vaccine may teach the immune system to recognize and kill cancer cells that     express NY-ESO-1.   "
38990|NCT02775279|"     Compelling epidemiological evidence indicates that alterations length of telomere, are     associated with the initiation and development of ischemic heart disease. This study was     undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be     used as a risk predictor for acute coronary syndrome.   "
38991|NCT02775266|"     To evaluate the effectiveness of non surgical periodontal therapy in addition to     antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease   "
38992|NCT02775253|"     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),     play an essential role in regulating whole-body energy homeostasis. Recent studies also     reveal the presence of a subset of cells in WAT that could be induced by environmental or     hormonal factors to become brown-like cells, and this beigeing process has been suggested     to have strong antiobesity an antidiabetic benefits. More recently, one study showed that     Short-term cold acclimation (10 days) improved insulin sensitivity, but did not activate the     browning of subcutaneous white adipose in patients with type 2 diabetes mellitus. Here,     investigators hypothesize that a chronic cold acclimation can activate the the browning of     subcutaneous white adipose in patients with type 2 diabetes mellitus.   "
38993|NCT02775240|"     The purpose of this study is to determine how an investigational treatment (maribavir) is     handled by the body when administered with two already approved drugs (digoxin and     dextromethorphan). The study will also look at the safety and tolerability when maribavir is     coadministered with digoxin and dextromethorphan versus digoxin and dextromethorphan alone.   "
38994|NCT02775227|"     Pancreatic resections carry a high risk for complications, especially pancreatic fistula.     Both hydrocortisone and pasireotide have been shown to be effective in reducing complications     in earlier RCTs. The aim of this study is to compare the effectiveness and safety of these     two drugs in preventing complications of pancreatic surgery.   "
38995|NCT02775214|"     The purpose of this study is to compare two different ways of placing breathing tubes for     surgery. Both ways are used currently to place breathing tubes and are safe and effective.     This study seeks to determine if one way is better than the other for infants with pyloric     stenosis.   "
39006|NCT02775071|"     This study will evaluate the relationship between psychopathology, disordered eating, and     impulsivity (measured by clinical interview, self-report measures, and objective testing) on     changes in weight and psychosocial status in the first two years after bariatric surgery.     Participants will be 300 adults who plan to undergo bariatric surgery. Participants will     complete four assessments over a two-year period, one at baseline (before surgery) and 6, 12,     and 24 months after surgery. Each assessment will include computer tasks, surveys, clinical     interview, urine test, waist circumference and height/weight measurement. The investigators     will track how psychopathology, disordered eating, and impulsivity are related to changes in     weight and psychosocial status following bariatric surgery.   "
38996|NCT02775201|"     The plantaris tendon is recognised as an important factor in non-insertional Achilles     tendinopathy (NIAT). A biomechanical study found the plantaris tendon is stiffer and stronger     than the Achilles tendon (AT), thus reducing its capacity to elongate in response to loading.     This is hypothesized to result in friction between the AT and plantaris in some NIAT     patients. Current treatment is conservative management: physiotherapy and high volume     injection of the paratenon. However 29% of patients fail to respond to conservative     management and those with plantaris related symptoms require its surgical excision and     stripping of the ventral aspect of the AT through a 3cm medial incision. This is performed in     theatres under general anaesthetic with good or excellent results reported in 90% of cases.      Purely cutting the plantaris tendon using a minimally invasive endoscopic technique has also     been successful. The plantaris tendon is easily visualized under ultrasound scan (USS) and     tenotomy of tendons under USS guidance is performed elsewhere. Tenotomy of the plantaris     tendon under USS guidance would necessitate a 5mm incision and may be performed under local     anaesthetic as an out-patient. The current study thus plans a randomised clinical trial to     compare outcomes (VISA-A scores and ultrasound tissue characterisation scans) from patients     with NIAT undergoing plantaris release using an open surgical procedure with those undergoing     a minimally invasive US guided procedure. The former is known to provide good clinical     outcomes; however the latter could significantly reduce post-operative scarring, recovery     times and costs. Findings will ensure ethical, quality and cost effective patient care.   "
38997|NCT02775188|"     The purpose of this study is to ascertain if home-based therapy with monitoring via     telemedicine can overcome many barriers to compliance and improve rehabilitation following     ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks     during their outpatient physical therapy treatment. Subjects will undergo weekly physical     therapy or weekly physical therapy paired with InterACTION.   "
38998|NCT02775175|"     In this study the investigators will test the impact of a modified Ramadan Fasting regimen on     health and well-being. The 2016 Ramadan is around summer solstice in Germany making it one of     the most challenging fasting periods for participating Muslims. The modified Ramadan Fasting     consists of educational components around fasting, and advice for nutritional modifications     in order to support health and well-being during Ramadan, while the control group will     continue to fast as usual. The investigators will measure not only body weight/fat but also     include measures of psychological well-being, and spiritual practice, and serum markers for     blood lipids, and blood sugar. With this trial the investigators aim to determine, whether     such modifications around Ramadan will be beneficial for health and well-being.   "
38999|NCT02775162|"     A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic     machine profusion with static cold storage in human liver transplantation.   "
39000|NCT02775149|"     Not only caries but also exposure to acids can lead to loss of tooth structure. This     acid-related tooth structure loss is defined as dental erosion.      A relationship between dental erosion and occurence of reflux disease was shown in numerous     studies. On the one hand, patients with dental erosions frequently show reflux disease. On     the other hand, many - but not all - reflux patients show dental erosions. It is believed     that certain salivary parameters might explain, why not all reflux patients alike are     affected of dental erosions.      The aim of this study is to analyze the relationship and the extent of occurrence of dental     erosions and reflux symptoms, including investigation of certain salivary parameters.   "
39001|NCT02775136|"     HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and     accurately monitor physiological signs of the brain with minimal discomfort to patients,     providing information about normal or abnormal brain-related conditions and providing     decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable     of detecting and monitoring various neuropathologies, using the acoustic raw data derived     from the noninvasive procedure.   "
39002|NCT02775123|"     Investigators are planning a single center pilot randomized controlled trial to assess the     potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood     during cardiac surgery.      Investigators will screen all patients undergoing cardiac surgery and approach those deemed     at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular     replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op     chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF     <35%)].      Patients with end-stage renal disease (dialysis dependence), undergoing an emergency     procedure or an off-pump procedure, those who decline informed consent as well as those     enrolled in another conflicting study will be excluded.      Eligible patients will be approached, consented and enrolled in the trial. Patients will then     be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb     (intervention arm). The target population is 30 patients (15 per arm).      For this pilot study, investigators main outcome will be differences between the two arms in     measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline     (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB.      Secondary outcomes will be changes in coagulation factors serum levels, the need for     vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and     hospital length of stay as well as in-hospital mortality.      Recruitment period should span from May 2016 to April 2017.   "
39003|NCT02775110|"     This study evaluates the discontinuation of natalizumab either immediately or tapered off in     the treatment of multiple sclerosis. Half of the fifty (50) participants will discontinue     natalizumab immediately and the other half will taper off the drug, having two additional     infusions, one at six weeks- and one at eight weeks-post discontinuation.   "
39004|NCT02775097|"     Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness, the     epithelial thickness, and the stromal thickness in normal subjects and patients with various     corneal conditions.   "
39005|NCT02775084|"     The purpose of the study is to examine the effect of dietary n-3 polyunsaturated fatty acid     supplementation on subjects' pan CD4+ T cell function, cognition, and muscle function. Half     of the participants will receive fish oil, while the other half will receive a placebo (olive     oil).   "
46763|NCT02673541|"     The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™     stent versus the conventional approach using double pigtail plastic stents in the treatment     of patients with walled-off pancreatic necrosis.   "
39007|NCT02775058|"     The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.      Synergoss is a granulated bone graft intended for use in dental applications. It is composed     of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a     dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on     the ceramic granule surface.      The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS, a     synthetic dental graft coated with collagen. For this observational study, we will enroll     patients that already received a surgical intervention for sinus augmentation/ socket     preservation by means of SYNERGOSS to maintain and regenerate bone before installation of     endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just     before they receive the surgery for the installation of endosseous titanium implants, about     24 weeks after the first surgery for the implant of SYNERGOSS.      The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen     clinical benefit as declared in the Technical File.      The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those     declared in the Technical File.      The study design is a        -  National        -  Monocentric        -  Prospective: the participants are identified and then followed forward in time.        -  Observational: participants that have recently received the grafting with SYNERGIES as          part of normal and foreseen clinical procedures are enrolled in the study when they          receive surgery for titanium implant placement and observed over time, with no          substantial intervention other than the foreseen clinical treatment   "
39008|NCT02775045|"     The purpose of this study is to improve the overall management of patients with Eosinophil     Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the     endoscopy procedure. The investigators plan to identify a biomarker in the blood (a     measurable substance) that tracks with disease activity and will reduce the need for     follow-up endoscopies.   "
39009|NCT02775032|"     End-of-life care often fails in providing optimal patient-centred care and quality of life.     Patients frequently suffer from inadequate control of pain, from a lack of communication     about their illness and options for treatment, and from poor psychosocial and spiritual     support. Advance care planning (ACP) can tackle these problems by providing patients with an     opportunity to formulate their wishes and plan their future care, should they become     incapable of participating in medical treatment decisions. Previous studies show that ACP     improves concordance between patient's preferences and end-of-life care received and quality     of care at the end-of-life. However, ACP is yet to be embedded in routine clinical practice     and public consciousness. General practitioners (GPs) are in an ideal position to discuss ACP     with their patients. By introducing ACP during a routine office visit, GPs can facilitate a     structured discussion of the patient's wishes for end-of-life care. However, no ACP models     have been systematically developed and tested in general practice. We developed a complex     intervention to improve the initiation of ACP in general practice following the steps of an     international guidance for development and evaluation of complex interventions. Before     performing a full-scale intervention trial to study the effectiveness of this intervention on     quality of care and quality of life, this model needs to be validated and tested in a pilot     trial.   "
39010|NCT02775019|"     This study is designed to evaluate the impact of the regular consumption of probiotic     Lactobacillus reuteri-containing lozenges over a period of 42 days on parameters of oral and     general health in crew members of a naval ship at sea.   "
39011|NCT02775006|"     The objective of this study is to investigate the effect of docetaxel monotherapy and the     combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK     negative non squamous cell carcinoma.   "
39012|NCT02774993|"     Pulmonary cavitation, a hallmark of tuberculosis (TB), is the site of high mycobacterial     burden leading to disease transmission. The cause of tissue destruction leading to cavitation     in TB is primarily due to the host inflammatory response. A matrix degrading phenotype     develops in TB, in which the activity of host proteolytic enzymes, specifically matrix     metalloproteinases (MMPs) is unopposed by their specific Tissue Inhibitors of     Metalloproteinases (TIMPs), thus driving tissue destruction and cavitation in TB. This tissue     destruction causes morbidity and mortality. MMP inhibition with doxycycline has shown to     improve lung function in patients with chronic lung diseases but its use in TB is unclear.      We hypothesise that the MMP inhibitor doxycycline will reduce tissue destruction in human     pulmonary tuberculosis.      Specific aims:        -  To investigate the MMP and TIMP secretion and gene expression in M. tuberculosis (M.tb)          - infected primary neutrophils and monocytes from healthy volunteers taking doxycycline.        -  To investigate the intracellular signaling pathways modulated by doxycycline        -  To investigate the effects doxycycline has on biological markers of tissue destruction          in TB patients        -  To assess the tolerability and side effects of doxycycline with concurrent standard TB          therapy   "
39013|NCT02774980|"     Patients with depression are frequently treatment resistant. Clinical manifestations of     depression are various, but cognitive dysfunctions are commonly present. Many factors are     involved in treatment resistance. As no biological marker is available, clinical markers     could be considered in predicting response to antidepressive treatment.      The aim of this study is to investigate the relation between the cognitive changes and the     remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and     Rush classification).      To explore the dynamics of cognitive dimension associated to clinical and functional     remission, the investigators will observe neurocognitive functioning before and after     introducing a new antidepressive therapy.   "
39034|NCT02774707|"     Human autologous serum is commonly used in the treatment of dry eye disease. However,     different patients may have different effect with autologous serum treatment. We would like     to find if different autologous serum had different component of cytokines in different     etiologies of dry eye.   "
39035|NCT02774694|"     Interventional pain management for back and neck pain is widely used, but the indications and     relative merits of these techniques rest subject to discussion. This study aims to identify     prognostic criteria for patients who might specifically benefit from interventional pain     management. Specifically, the nociceptive reflex threshold will be investigated, which is a     measure of central sensibilisation and thus a potentially important prognostic factor.   "
39014|NCT02774967|"     The gold standard for the treatment of gingival recession, is the coronal repositioning of     the flap associated with the subepithelial connective tissue graft. The acellular dermal     matrix (ADM) has been used as a substitute a subepithelial connective tissue graft in     periodontal plastic surgery and mucogengivais, and has achieved similar results. The use of     ADM has the advantage of avoiding possible pre and postoperative complications, as well as     overcome the limitations presented by autograft. The different surgical techniques used for     root coverage seek predictability and success. For this, besides the type of incision     placements flap and graft are of utmost importance because the healing benefit and outcome.      The aim of this study is to compare two surgical techniques for root coverage and evaluate     which one provides better cosmetic results and less morbidity . 20 adults , nonsmoking     patients , showing multiple bilateral gingival recessions , class I or II Miller located in     canine, first and second premolars are selected. Both techniques use the ADM as a graft.     However , in one Quadrant partial flap will be held together with relaxing incisions through     an incision intrasucular , ADM will be positioned 1 mm apical to the cementoenamel junction     (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant a minimally     invasive technique periosteal envelope above does not use relaxing incisions , preserves the     buds will be held , as well as avoiding any scars, the graft will be used to ADM. The     clinical parameters (probing depth, clinical attachment level, bleeding on probing index,     height and width of the gingival retraction and height and thickness of keratinized gingiva)     will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to     surgical procedures. In addition, measurements of photographic gingival recession with the     aid of software will be performed.   "
39015|NCT02774954|"     The study will test the efficacy of a hour long, one-on-one, active listening counseling     session (called Change the Cycle or CTC) aimed at reducing behaviors among active people who     inject drugs (PWID) that research has found to facilitate uptake of injection drug use among     non-injectors. The study will involve ~1,100 PWID who will be randomized to CTC or an equal     attention control intervention on improving nutrition. Participants will be recruited in Los     Angeles and San Francisco, California and followed up at 6 and 12 months to determine changes     in direct and indirect facilitation of injection initiation among non-injectors.   "
39016|NCT02774941|"     The purpose of this study is to compare clinical outcomes related to the current practice of     using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh     nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe     asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators     hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital     admissions and decrease length of stay in CMCED when compared to the current practice of     using a JN and AM or MP.   "
39017|NCT02774928|"     Development of pulmonary hypertension (PH) in chronic lung diseases has both functional and     prognostic implications .      PH in Lung diseases is usually mild to moderate with preserved cardiac output, and evolves     slowly alongside the progression of lung disease and hypoxemia .      However, a minority of patients develop severe PH with elevations in pulmonary artery     pressure that have been described as ''out of proportion'' to the underlying disease .      The aim of this study is to compare the characteristics and outcomes of consecutive patients     with PH-due to lung diseases diagnosed at our specialist referral center over a 1-year     period.   "
39018|NCT02774915|"     Investigators are interested to explore the clinical and pathological characteristics of     breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during     pregnancy, median gestational age at diagnosis, the level of the tumor differentiation     patients present with, during pregnancy, and the hormonal-receptor status. Investigators plan     to collect prospective quality research databases that could provide further important     information concerning this condition and serve in both short- and long-term sequelae in     mother and fetus.   "
39019|NCT02774902|"     The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin     on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants     following a single oral dose of TAK-438.   "
39020|NCT02774889|"     The overall purpose of this multi-phase study is to develop (Phase 1) and test potential     effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls     prevention maintenance program for Stepping On (SO) graduates in a group randomized trial     (Phase 2).      This application refers to effectiveness component of Phase 2, which entails the randomized     clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail     process evaluation of the Stepping Online intervention group only.   "
39021|NCT02774876|"     Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and     protein have been shown to also impact the postprandial glucose control, adding to the     complexity of meal insulin calculation. Few studies have looked at the effect of     macronutrients other than carbohydrates on postprandial glucose excursions with the     closed-loop strategy. The objective of this study is to test whether the single-hormone     closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed     carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed     carbohydrate content only.   "
39022|NCT02774863|"     Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe).     Experiencing NE, psycho-emotional development and brain child may be impacted generating     psychic suffering signs may progress to severe developmental disorders. The recognition of     suffering can prevent and treat these disorders.      This research promotes a multi-professional device, centered on observation, collection of     expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The     investigators assume that this collection requires the crossing of looks of a child     psychiatrist and a repeated observation at home by a trained nurse.      The two devices described in these two groups are devices set up as part of the routine     management of these patients. Usually, depending on the means of structures (human and     financial), one of these devices may be preferred over another.   "
39023|NCT02774850|"     Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens     that result in periods of profound neutropenia leaving patients susceptible to severe     infectious complications. Infectious complications are the leading cause of treatment related     mortality among AML patients, but there are little clinical data to inform whether management     of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The     primary objective of this study is to compare the clinical effectiveness of outpatient versus     inpatient management of neutropenia in children with AML.   "
39057|NCT02774408|"     In this 2-phase cross-over study the investigators test the hypothesis that automated     adjustment of the inspired oxygen with the combined use of synchronized noninvasive     SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the     intended oxygen saturation range as compared to automated FiO2 adjustment alone.   "
39024|NCT02774837|"     Chronic Hepatitis B is the most common cause of chronic viral liver disease worldwide     afflicting 350 million persons, leading to significant morbidity and mortality due to liver     disease and HCC in 20-40% of infected persons. With the advent of nucleoside analogues, this     rescued patients with significant risk of disease progression, but in most circumstances,     therapy was needed long term as HBsAg seroclearance was an uncommon occurrence, and stopping     therapy was associated with relapse of disease and hepatitis B flares. The use of pegylated     interferons showed increased HBeAg seroconversion and HBsAg seroclearance rates compared to     nucleoside analogues , however combination nucleos(t)ide analogue therapy has been quite     disappointing. However a recent showed that the combination of telbivudine and tenofovir in a     response guided therapy design, had a remarkable 6% HBsAg seroclearance at week 52 in     patients. Such results require further confirmation. There is currently an unmet need for the     large number of patients on long term nucleoside analogue therapy who have not achieved HBeAg     seroconversion or HBsAg seroclearance. Such patients are seeking alternatives to long term     therapy hence an exploration of other therapeutic strategies is attractive. An additional     benefit of telbivudine has been the surprising improvement in renal function and this study     seeks to examine whether this can improve the renal impairment that may be seen with     tenofovir. Our study proposes to examine if the combination of tenofovir and telbivudine can     improve endpoints. Patients fulfilling inclusion and exclusion criteria will be randomized to     tenofovir or tenofovir and telbivudine (1:1 ratio). The primary endpoint will be a qHBsAg     reduction of >1log at week 96, which may predict future HBsAg seroclearance, which is also a     secondary endpoint. An additional primary endpoint is increase in eGFR in the combination arm     compared to the monotherapy arm. The study aims to enroll 146 patients randomized 1:1 ratio     (73:73) patients. Multivariate analysis will be performed of baseline and on-treatment     factors that predict the primary outcome.   "
39025|NCT02774824|"     This is a 9-months extension to the following study, protocol number: 003-03: A study to     evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients     undergoing coronary artery bypass grafting (GABG). Participation is allowed exclusively to     participants enrolled in the main protocol SOMVC001 (GALA).   "
39026|NCT02774811|"     Multi-centre randomised controlled trial of selective laser trabeculoplasty compared with     prostaglandin analogue therapy as primary treatment for high tension open angle glaucoma.      Participating centres are:      Institute of Ophthalmology, UCL, London, UK McCord Hospital, Durban, South Africa Innovation     Eye Centre, Kisii, Kenya   "
39027|NCT02774798|"     Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been     studied in our department over the last 6 years. Sound waves pass into a balloon placed in     the anal canal and are used to measure the cross-sectional area. By gradually increasing and     decreasing the pressure in the balloon the investigators can measure the pressure at which     the cross-sectional area starts to increase and decrease, and the anal canal starts to open     and close. This assessment mimics the natural opening and closing of the anal canal and the     effect of squeezing the muscles.      Rectal intussusception occurs when the rectal wall telescopes into itself distally and is     termed prolapse when it protrudes through the anal canal. Not all patients will require     surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal     incontinence. Currently, the Oxford grading system through radiological testing is used for     classifying severity of rectal intussusception and prolapse; however this does not give us     sufficient information about the anal sphincter muscles.      The gold standard investigation of the anal sphincter muscles has been manometry which     measures anal canal pressure at rest and during squeeze. However, it has limitations. In     previous studies AAR has shown promise in the assessment of faecal incontinence and, that     unlike manometry, it has been able to distinguish between different types of incontinence.     Thus far, it has not been studied in patients with rectal intussusception and it is hoped     that AAR parameters may provide an indication of when rectal intussusception becomes overt     rectal prolapse. This can inform the clinician to guide further management of a group of     patients with a condition that can have significant impact on quality of life.   "
39028|NCT02774785|"     The new device we are looking at is called the MarginProbe. It is a disposable probe which     measures the margins of tissue removed to check they are clear of cancer cells, during breast     conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue     if necessary, during the same operation if any involved margins are identified. This     minimises the need for further repeat operations.      Previous studies carried out elsewhere in the world (USA and Israel) have identified that the     probe reduces re-excision rate but there has never been a study in the UK.      The trial involves randomly allocating patients once they are in theatre, to either the     MarginProbe procedure after breast conserving surgery and radiology has been completed, or     not.   "
39029|NCT02774772|"     The investigators will collect a range of physiological, behavioural and environmental data     using current mHealth and home-monitoring systems, environmental databases and patient     characteristics, to determine to what extent asthma control and the occurrence of asthma     exacerbations can be predicted.   "
39030|NCT02774759|"     The goal of this research study is to learn if a home-based physical activity program is     feasible and can help endometrial cancer survivors lose weight.   "
39031|NCT02774746|"     The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7     weeks in stable patients with gastroschisis is superior to observation and expectant     management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will     complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated     institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be     randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The     primary composite outcome will include stillbirth, neonatal death prior to discharge,     respiratory morbidity, and need for parenteral nutrition at 30 days.   "
39032|NCT02774733|"     Objective: The main target of this study was to research the correlation between the     pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients     with type 2 diabetes (T2DM) without diabetic retinopathy (DR).      Method: T2DM patients without DR were choose to research the correlation between the     pulmonary function and the circulatory parameters of retrobulbar blood vessels. The primary     endpoints were the pulmonary function parameters; The secondary endpoints were the HbA1c,     FPG, 2hPG, WC, and BMI. The tertiary endpoints were the blood-fat; In addition, the     retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler     imaging (CDI).   "
39033|NCT02774720|"     The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare     the effectiveness of centre-based and home-based physical activity in helping people with MCI     and early dementia meet physical activity recommendations. The primary outcome is achievement     of physical activity recommendations. Secondary outcomes include cost-effectiveness and     improvements in health and function.   "
39058|NCT02774395|"     The endometrial cancers are among the most common malignancies in postmenopausal women with     an incidence on the rise. It is most often a endometrioid adenocarcinoma (grade I, II, III).     Other histological types are represented mainly by the clear cell carcinoma, papillary serous     carcinoma, the carcinosarcoma. The main risk factors for endometrial cancer are age, obesity,     diabetes, hypertension, hormone replacement therapy with estrogen and tamoxifen.      Endometrial hyperplasia usually precedes endometrial cancer is classified by degree of     cytologic atypia. Tumor grade quantifies the degree of differentiation and significantly     influences the prognosis. Most research has been applied to define the role of estrogen in     these cancers, however an accumulation of data indicate that the general process of     tumorigenesis is closely related to immune and inflammatory microenvironment of the tumor. In     fact, the microenvironment may be seen as a prognostic parameter of tumors or even predictive     of therapeutic response.      Recognized as the key molecules responsible for leukocyte recruitment into the tissues, the     chemokine-receptor pairs are key players in the immune response, including the anti-tumor     immune response but also the inflammatory response. The chemokine-receptor pairs are also     involved in many other basic processes such as proliferation, survival or cell death.      The objective of this study was to evaluate the prognostic value of the expression of the     chemokine fractalkine (FKN) and its receptor CX3CR1 for the development of endometrioid     adenocarcinomas.      Chemokine FKN has the particularity to exist in two forms, a soluble (FKNs), like all     chemokines and membrane form (FKNm). The FKNs, resulting from proteolytic cleavage of the     FKNm, is provided with chémoattractantes properties. FKNm the present adhesion molecule     properties.      The role of FKN in cancer biology is complex.      To date, the role of FKN in endometrial cancer has not been reported. Similarly, the precise     role of FKN in the physiology of the endometrium is unknown.      Nevertheless, fractalkine is one of the most expressed in endometrial chemokines. The     expression of FKN and its CX3CR1 receptor is detected in the endometrium at all stages of the     menstrual cycle. The respective levels of expression of each are fluctuating and largely     dependent on the cycle of stage suggesting a possible control by estrogen and progesterone     control described elsewhere ovarian level and endothelial. The cells of the endometrial     glandular epithelium, macrophages, neutrophils and NK cells infiltrated in this tissue as     well as the endothelial cells of blood vessels express FKN. Interestingly, all the cells     mentioned above express CX3CR1, except for NK cells and unlike most tissues, the CD8 cells,     present in the endometrium, do not express CX3CR1.      In addition, the strongest expression of FKN and CX3CR1 cells by endometrial epithelial     coincides with the maximum activity of the glandular epithelium suggesting a possible     autocrine loop promoting cell proliferation of the endometrium. Concurrently with the peak of     fractalkine, an accumulation of monocytes / macrophages and neutrophils is observed in the     endometrium. It appears, moreover, that the balance between the soluble and membrane forms of     FKN is important for positioning, infiltration and activity of immune cells within the     endometrium.      Current knowledge on the involvement of FKN / CX3CR1 axis in the physiology of the     endometrium, although incomplete, point unequivocally the potential role of this ligand pair     / receptor in the physiology of the tissue and also suggest that a malfunction of this axis     could easily cause various diseases.      Chronic inflammation of a tissue, largely dependent on macrophage infiltration rate,     generally represents the tumor development. The endometrium is subjected to physiologically     cyclic and regular inflammatory episodes, mirrors for the expression of chemokines and     leukocyte infiltration. However, prolonged leukocyte infiltration establishing chronic or     prolonged inflammation of the endometrium could help shape a favorable microenvironment in     tumor development. Curiously, the axis FKN / CX3CR1 is involved in the development of several     inflammatory diseases, including obesity and diabetes are also risk factors for endometrial     cancer.      A change in the expression of FKN and / or CX3CR1 is potentially capable of altering the     inflammatory physiological cycle of the endometrium and therefore likely to be an element to     consider in the evaluation of cancer risk factors of the endometrium.      The assumption is that the FKN / CX3CR1 couple could intervene in the pathophysiology of     endometrioid adenocarcinomas.   "
39036|NCT02774681|"     The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor     activity against the breast cancer that has spread to the brain and also to determine the     overall radiographic response rate in the CNS. Palbociclib is an anti-cancer medication that     has been shown to stop cancer cells from growing. It has been approved in hormone positive     breast cancer, along with other hormone therapies and has been found to be effective. The     preclinical studies suggest that the drug may also have activity in other types of breast     cancer, such as HER2 positive breast cancer. The purpose of this study is to see if the study     drug is effective in patients with brain metastasis, who have HER2-positive breast cancer.   "
39037|NCT02774668|"     The present study is designed to examine the effect of changes in body weight and related     parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter     proposed to be studied here is the impact of fructose restriction and weight loss on serum     uric acid concentrations and arterial stiffness.   "
39038|NCT02774655|"     The purpose of this study is to test in overweight and inactive adults whether the new PAI     eHealh APP leads to better adherence to a physical activity regimen than the wearable step     counter App from the market leader FitBit, and to evaluate if improved adherence will be     reflected in a better cardiovascular profile in this group.   "
39039|NCT02774642|"     This study aims to examine whether integrating insomnia and PTSD treatment will enhance     sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing     integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus     PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such     benefits would further the VA's commitment to improving the mental health, recovery, and     community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings     from the proposed study offer a unique opportunity to determine the malleability of     mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes     among this vulnerable population and to inform future treatment development and research.     Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment     and ultimately help affected Veterans live richer, more productive lives.   "
39040|NCT02774629|"     Local lyophylized food extracts are available useful in skin prick test and atopy patch test     to confirm food allergy. However, the investigators want to know the duration that the     investigators can keep the extracts for the usage in this purpose.   "
39041|NCT02774616|"     Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right     ventricular lead to fulfill requirements by the notified body and to support regulatory     approval outside of the CE region   "
39042|NCT02774603|"     The aim of this study is to define and evaluate the efficacy of Aquatic Locomotor Training     (ALT) compared to overground Locomotor Training in improving ambulatory function and     health-related quality of life. The investigators hypothesize, that Aquatic Locomotor     Training is capable of producing outcomes that are as good as, or better than, overground     Locomotor Training.      Aquatic Locomotor Training may be another tool for therapists to utilize for clinical     improvements in function and gait for the Spinal Cord Injury (SCI) population.      To determine the efficacy of Aquatic Locomotor Training on improving rehabilitation outcomes     among patients with incomplete traumatic cervical Spinal Cord Injury by assessing these     parameters:        1. Walking speed and endurance        2. Functional balance and fall risk        3. HRQoL      To describe the feasibility of conducting Aquatic Locomotor Training as an Locomotor Training     modality for the rehabilitation of patients with incomplete traumatic cervical Spinal Cord     Injury.   "
39043|NCT02774590|"     This research is being done to determine the safety and tolerability of timolol in the     treatment of acne and rosacea. The investigators will also look for specific biomolecular     changes in acne or rosacea skin when it is exposed to timolol.      Timolol is approved by the Food and Drug Administration (FDA) for the treatment of glaucoma.     In dermatology, it has been used as a treatment to decrease the size of vascular (blood     vessel) malformations in infant skin. Timolol is not approved for use in acne or rosacea and     its use in this study is investigational.      Many people with rosacea have telangiectasias which are small, red dilated blood vessels on     the skin. They also suffer from flushing and acne-like lesions. Better treatments than those     currently available are desired.      Acne vulgaris, or acne, is another chronic inflammatory and very common skin disease that     affects about 8 out of 10 young adults and adolescents. Signs of acne include papules and     blackheads that are often called primary lesions because they represent an active form of the     disease. There are also secondary lesions that can form later; they are known as acne scars   "
39044|NCT02774577|"     Noninvasive assessment of VO2 during a single session of whole body vibration and changes in     blood flow caused by the acute activity.   "
39045|NCT02774564|"     The purpose of this study is to the effect of three single oral doses of nebicapone (50 mg,     100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a     single-dose of controlled release levodopa 200 mg/carbidopa 50 mg (Sinemet CR 200/50).   "
39046|NCT02774551|"     This intervention study will be conducted on patients included in a nationwide and     prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study     (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden between     2013-2018, identified through pathology departments and included in the cohort 1 year after     surgery. A comprehensive interview is conducted by a research nurse during a home visit using     patient reported outcomes on several HRQOL, psychosocial, emotional and nutritional aspects.     Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively.      All patients within OSCAR are invited to the intervention trial. Half of the eligible     patients will be randomised to intervention and half to standard care (control group) by     means of block randomisation method. The intervention group will be encouraged to adhere to a     physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple     strength training exercises twice a week as instructed by the research nurse. The control     group will follow their routine daily physical activity. HRQOL measures, height and weight,     body composition, muscle strength, functional mobility and strength, and dietary intake are     assessed before and after the intervention. Compliance will be ensured by means of a daily     physical activity dairy and a weekly follow up on telephone with all patients.   "
39048|NCT02774525|"     The co-occurrence of child maltreatment and parental substance-use problems is a major public     health problem with serious consequences for children, parents, families, and the community     at large. The need for effective dual treatment of caregiver substance abuse and child     maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies     with substance-using parents who have engaged in child maltreatment. This project examines     two evidence-based treatments—Contingency Management for substance-use problems and Pathways     Triple P parenting intervention to improve parenting for prevention of child-maltreatment     recurrence. These two systematic interventions are being tested in the context of traditional     outpatient treatment for substance-use problems.   "
39049|NCT02774512|"     This is a monocentric prospective non randomized phase 0 clinical trial targeting patients     with colon cancer for whom an upfront surgery has been advised by the pluridisciplinary team.   "
39050|NCT02774499|"     Oral medications like gabapentin and acetaminophen are commonly given to patients prior to     surgery to provide balanced anaesthesia. Intravenous methadone has been shown to decrease     postoperative pain as well as postoperative nausea and vomiting, which are known barriers to     discharge. Oral methadone would be a convenient alternative to give as a preoperative     medication with its bioavailability approaching 80%. No clinical trials to date have explored     the utility of oral methadone as a preoperative analgesic to improve postoperative outcomes.     Current literature shows preoperative IV methadone reduces opioid consumption in the     perioperative period for cardiac surgeries; therefore, investigators hypothesize that     preoperative oral methadone will also reduce postoperative opioid consumption in patients     undergoing sternotomy for cardiac surgery.   "
39051|NCT02774486|"     The primary cause of being overweight is an imbalance in calories consumed and energy     expenditure. A surplus in energy intake might result in body fat deposition and thereby body     weight gain. Therefore, food intake regulation is crucial to control the body weight gain.      Appetite regulation plays an important role in determining the food intake, which is a     complex process influenced by the individual (physiology and psychology) and environment.     Satiation (process that leads to the termination of eating) and satiety (decline in hunger,     increase in fullness after a meal has finished) are the precursors of appetite regulation,     which may be induced by various food components such as macronutrients, water, alcohol and     non-digestible polysaccharides. High viscosity and swellable/bulking food components such as     dietary fibre are expected to elicit stronger satiation/satiety than the macronutrients or     clear liquid. Due to its unique physicochemical properties, dietary fibre has been recognized     as potential ingredient that helps to enhance the sensation of satiety in the upper gut by     increasing gastric distension and delaying gastric emptying, which subsequently reduces the     food intake.      IQP-AK-102 comprises of a proprietary blend of dietary fibres known to promote a feeling a     fullness. The objectives of this study are to evaluate the efficacy and safety of IQP-AK-102     on appetite reduction in overweight subjects during a 4-weeks interval.   "
39052|NCT02774473|"     Patients with a history of metastatic breast cancer who are candidates for participation in     the companion therapeutic trial, UPCC 06115 A Phase I Trial of Ribociclib (LEE011) and     Weekly Paclitaxel in Patients with Rb+ Advanced Breast Cancer may be candidates for this     imaging study. Patients may participate in this study if they are at least 18 years of age,     most participants will be receiving care at the clinical practices of the University of     Pennsylvania. Patients that meet the eligibility criteria will be approached about study     participation regardless of race or ethnic background.      The investigators anticipate enrolling up to 20 participants with metastatic breast cancer     who meet eligibility requirements for this study and for the companion therapy trial UPCC     06115 A Phase I Trial of Ribociclib (LEE011) and Weekly Paclitaxel in Patients with Rb+     Advanced Breast Cancer, Accrual will likely occur over approximately 4 years.      Positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity     in sites of metastatic disease using the investigational radiotracer [18F]fluorothymidine     (FLT). Imaging will occur prior to starting therapy on the separate therapeutic protocol UPCC     06115. Patients may undergo a second FLT PET/CT scan following a 3-day run of ribociclib     (LEE011) (day -6 to -4) on Day -3 (± 1 day) and a third FLT PET/CT scan on cycle 1 day 1 (-1     day) before starting treatment with Paclitaxel to compare changes in FLT uptake measures.   "
39053|NCT02774460|"     The PHYSIC study aims to investigate the potential for precision medicine in the treatment of     high blood pressure.      It is a double-blind, randomized, repeated cross-over trial with six treatment periods: four     classes of blood pressure-lowering drugs where treatment with two classes are repeated for     each patient. The classes of blood pressure-lowering drugs to be tested are a diuretic, a     calcium channel blocker, an ACE-inhibitor and an angiotensin receptor blocker.   "
39054|NCT02774447|"     The aim of this study is to investigate if day-case closure of ileostomy is feasible and     safe.   "
39055|NCT02774434|"     The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and     as part of standard of care all hospitalized newborns are routinely monitored for the     development of high bilirubin or jaundice every 8-12 hours. One device approved and used in     both Canada and the United States is the Draeger Jaundice Meter JM-103, a non-invasive     medical device. It has been proven to be effective in patients >35 weeks gestational age.     Recently the JM-103 has been upgraded to include a bigger touch screen, greater storage and     functionality. The rest of the features of the JM-103 and JM-105 are identical. In order to     test the accuracy of the JM-105 neonates from ≥ 24 weeks gestational age who have or have not     undergone phototherapy will be prospectively monitored for transcutaneous bilirubin (TcB)     using the JM-105. The measurements will be compared to a physician-ordered total serum     bilirubin (TSB).   "
39060|NCT02774369|"     It has been suggested that the practice of physical exercise can improve sleep, but few     studies have investigated this issue in the context of cancer, despite the proven benefits of     exercise in this population. This randomized-controlled trial (RCT) aimed to compare the     efficacy of an aerobic intervention program to that of a self-administered     cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and     women with insomnia symptoms and treated within 6 months for a non-metastatic cancer     participated in the study.   "
39142|NCT02773303|"     This project aims:        -  to further explore the effectiveness of a novel sonified Neurofeedback management          therapy for children diagnosed with Autism Spectrum Disorder (ASD)        -  to determine if balance control is different before and after therapy   "
39061|NCT02774356|"     This mentored student research project is funded by the Graduate Research Partnership Program     with a projected timeline for data collection in the summer of 2015. Previous research has     shown that language experience alters the way the human brain processes speech information.     This phenomenon takes place very early in life and is referred to as Native Language Neural     Commitment. For instance, as the Japanese language does not have the l-r speech sound     contrast, Japanese infants start to show difficulty in hearing differences between the     English l and r sounds at 12 months of age but not when they were at 6 months old. Learning     the l-r distinction later in life proves to be very difficult for the Japanese school     students and adults. Brain imaging studies have further revealed specific brain regions that     are changed by language learning. But the evidence in support of the Native Language Neural     Commitment theory is based on cortical-level measures. The proposed study extends the     measurement to the subcortical level at the brainstem. The target language that the     investigators are interested in studying is Mandarin Chinese, which is known for its use of     lexical tones to express different words. For instance, the Chinese syllable ma means     mother when it is spoken with a flat tone, and it means hemp when spoken with a rising     tone. English, by contrast, does not employ lexical tones, and it is considered a non-tonal     language. Does the Chinese learning experience fundamental change the way that pitch     information is coded in the human brain? Does it happen at both cortical and subcortical     levels? Previous research has shown evidence for a positive answer to both questions. But the     direct evidence for brain-behavior correlations at the subcortical level is still missing.      The proposed cross-language study will test Chinese-speaking and English-speaking adults to     investigate Native Language Neural Commitment at the subcortical level. The investigators are     interested in differences in the two subject populations by examining the relationship     between brainstem pitch tracking and behavioral pitch perception in linguistic and     nonlinguistic stimuli.      The results of the proposed project will contribute to the understanding the role of the     subcortical brainstem in Native Language Neural Commitment, which have significant     implications for the development of auditory/speech training programs and assessment tools     utilizing the brainstem frequency following measure to monitor progress in second language     learning and test clinical populations.   "
39062|NCT02774343|"     The purpose of this research study is to determine whether a medication called pioglitazone     (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain     structural changes associated with cocaine use and reduce cocaine craving and drug use in     cocaine dependent patients.   "
39063|NCT02774330|"     Improving healthy food availability and decreasing the availability of high calorie, low     nutrient products, particularly in underserved communities, has been identified as a leading     strategy for local governments to prevent obesity. However, policy action in this area to     date has been limited. This R01 will examine the impact of a local policy change that     establishes minimum stocking criteria for a wide array of healthy foods as a requirement of     food store licensing. To our knowledge, this is the only policy of its kind in the US. As     such, if it is successful, it could serve as an important model policy for other local     governments seeking to increase healthy food availability and prevent obesity through local     policy action.   "
39064|NCT02774317|"     With the advent of measures to try to decrease the incidence of transfusion-related acute     lung injury (TRALI), the Blood Bank industry is attempting to avoid collection of plasma from     female donors who have been pregnant in order to reduce the transfusion of plasma that may     contain HLA antibodies. This has led to a decrease in the number of donors available for the     production of fresh frozen plasma (FFP). Per Blood Bank regulatory standards in the United     States, FFP must be frozen within 8 hours of collection. Plasma that is frozen within 24     hours of collection is called FP24, and it is produced when whole blood cannot be processed     within the 8-hour time period for the generation of FFP. Studies of coagulation factors in     FFP and FP24 have shown that coagulation factor activities are adequate to maintain     hemostasis in both products. Many hospitals are using FFP and FP24 interchangeably in adults,     and occasional hospitals are using these products interchangeably in neonates. However,     studies concerning the use of FP24 in neonates have not been performed.      The investigators propose a single center prospective pilot study comparing the clinical     efficacy of FFP vs. FP24 in 50 nonsurgical neonates and babies up to age 6 months requiring     plasma for an International Normalization Ratio (INR) of 1.5 or more.      This protocol describes a pilot study to compare the use of FFP with FP24 in nonsurgical     neonates. Use of plasma in these cases is mostly for patients with perinatal hypoxia or     necrotizing enterocolitis and an INR of 1.5 or more. Transfusion of plasma (10 to 15 ml/kg)     is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated     by the patient's clinicians, and monitored with prothrombin time (PT), partial thromboplastin     time (PTT), and INR.   "
39065|NCT02774304|"     The goal of the study is to determine Eadyn as a functional measure of arterial load, in     conjunction with other actual afterload indices, derived from both invasive arterial pressure     tracing and non-invasive signals, such as arterial saturation, non-invasive cardiac output     obtained by bio-reactance, and non-invasive stroke volume. A secondary aim is the correlation     of the different non-invasive signals with the invasive arterial pressure tracing     characteristics.   "
39066|NCT02774291|"     This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine     T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination     chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer     that has spread to other places in the body (metastatic) and expresses the gene NY-ESO-1.     Donor white blood cells that are treated in the laboratory with anti-cluster of     differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving more than one drug (combination chemotherapy) may kill more     cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to     kill metastatic cancer cells. Giving anti-ESO (cancer/test antigen) mTCR-transduced     autologous peripheral blood lymphocytes together with combination chemotherapy and     aldesleukin may kill more cancer cells.   "
39067|NCT02774278|"     This study will assess potentially predictive markers of efficacy in participants with NSCLC     receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until     disease progression, unacceptable toxicity or death.   "
39068|NCT02774265|"     The purpose of this study is to perform a pragmatic randomized controlled trial to compare     the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic     acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower     extremity fractures.   "
39069|NCT02774252|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
39099|NCT02773862|"     Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit     (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure     (ICP) is measured. An increase in the intracranial pressure might suggest secondary     neurological deterioration and is considered an alarming symptom. Current practice is to     insert an invasive monitor through a burr hole in the skull with the risk of bleeding and     infection. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP     non-invasively through an acoustic signal.   "
39070|NCT02774239|"     This is a prospective open-label, uncontrolled, single-blind, pilot clinical trial.      The primary objective is to assess the efficacy, safety, feasibility and tolerability of SCIG     in patients with worsening MG.      Participants with moderate worsening of MG symptoms (MGFA Class II and III) who are     considered to be appropriate for immunoglobulin therapy will be screened for the study by the     treating neurologist.      Patients will be receive 2gm/kg (150gm for a 75kg patient) of 20% SCIG (Hizentra) infused     over 4 weeks in a dose escalating manner.      Additionally, this study will be assessing the feasibility of employing SCIG as an     alternative therapy to IVIG in patients with MG exacerbation. The cost-effectiveness of SCIG     versus IVIG will be evaluated, and the impact of SCIG therapy will be assessed from both a     health-resource perspective and from a patient perspective.   "
39071|NCT02774226|"     Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the     top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent     evidence indicates that COPD is associated with multiple systemic consequences including     vascular endothelial dysfunction. Recently, it has been suggested that more patients with     COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary     complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO)     bioavailability resulting in vascular endothelial dysfunction in patients with COPD are     important as endothelial dysfunction has been indicated to be an independent predictor of     future atherosclerotic cardiovascular disease and events.   "
39072|NCT02774213|"     Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed     during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic     treatments and be treated for pain relief exactly as they would normally be by the     Investigator based on their needs. During their regular visits to the Investigator, patients     will complete questionnaires and Clinical Pain Assessments.   "
39073|NCT02774200|"     A one-arm exploratory clinical research program Study of Apatinib in Advanced Metastatic     Renal Cell Carcinoma （mRCC） Patients.It`s arm to evaluate the treatment of advanced     metastatic renal cell carcinoma in patients with objective response rate (ORR), disease     control rate (DCR), progression-free survival (PFS), overall survival (OS), quality of life     score (QoL) and safety.   "
39074|NCT02774187|"     The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with     hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with     hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).   "
39075|NCT02774174|"     This study is a single centre, non-randomised, post market clinical follow up examining     retrospective patient data from a series of surgical cases; which involved the endoprosthetic     replacement of the proximal humerus using the Stanmore Implant Worldwide METS (Modular     Endoprosthetic Tumour System) Proximal Humeral system.      The objective of this study is to evaluate the retrospective patient data where patients have     been followed up for at least 12 months post operation; to demonstrate the safety of the METS     Proximal Humeral replacement system.   "
39076|NCT02774161|"     This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer     that is early in its growth and may not have spread to other parts of the body. Diagnostic     procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and     find out how far the disease has spread.   "
39077|NCT02774148|"     The primary objective is to determine if intravenous acetaminophen decreases pain scores and     the amount of morphine equivalence received as compared to oral acetaminophen in patients     greater than 65 years old after sustaining a hip fracture.   "
39078|NCT02774135|"     This study evaluates the improvement of participation in everyday occupation among preschool     children with mild developmental disabilities as a result of Occupational Therapy     intervention.   "
39079|NCT02774122|"     This study is to compare the effectiveness of CAABT and masking therapy in the management of     subjective tinnitus in adults.Half of participants will receive CAABT, while the other half     will receive masking therapy.   "
39080|NCT02774109|"     Purpose:      To investigate the effects of fish oil on patients with chronic nonspecific low back pain.      Material and Methods Subjects: 52 participants will be recruited from outpatient department     of physical medicine and rehabilitation department and by poster.      Duration: 2016.04.21-2017.03.31      Methods: The participants will be randomly divided into the experimental group and the     control group through the draw, with 26 patients in each group. Participants in the     experimental group receive fish oil plus physical modality treatment. Participants in the     control group receive placebo plus physical modality treatment.      Assessment: Before the therapy starts, patients who match the inclusion criteria will be     evaluated using tools mentioned below:      General data: age, sex, body height, body weight, occupation, exercise habit      Rate current, best and worst pain intensity of low back pain during the previous week with     100mm Visual Analogue Scale (VAS)      Measure pressure pain threshold with pressure algometer      Measure lumbar spine range of motion in flexion and extension with tape measure      Assess endurance of back extensor muscles with Biering-Sorenson test      Classify the pain origin (nociceptive or neuropathic) with Chinese version of the     identification pain (ID pain) questionnaire      Assess the impact of low back pain to daily life with Chinese version of The Roland Morris     Low Back Pain and Disability Questionnaire (RMQ)      Assess the impact of low back pain to work performance and fatigue with Chinese version of     The Health and Work Performance Questionnaire (HPQ) and the Occupational Burnout Inventory      Assess the impact of low back pain to sleep quality with Chinese version of the Athens     Insomnia Scale      Draw 10ml blood for blood test (ESR and hs-CRP)      Participants will be followed up 4 weeks and 8 weeks after therapy starts and re-assessed of     pain intensity, pressure pain threshold, lumbar spine range of motion, back extensor muscles     endurance, and the impact of low back pain to daily life, work, and sleep quality. Blood test     will be committed again after therapy course finished.   "
39081|NCT02774096|"     With more and more people developing hypertension and atherosclerosis, the morbidity rate of     Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment for     Acute Aortic Dissection. However the secondary injury caused by reperfusion of spinal cord     could lead to Catastrophic complications,such as paraplegia, hemiplegia or even death. So     spinal protection is always the hot topic in clinical research.      Xenon is an ideal anesthetic gases with the following features,fast onset of action, stable     hemodynamics, clean and non-toxic.The animal researches have showed the protective effects of     xenon to alleviate the ischemia-reperfusion injury of the nervous system.Those clues suggest     that Xenon may have the potential protection of spinal cord in patients undergoing aortic     dissection repair.In order to clarify this hypothesis, the investigators designed this     randomized, controlled clinic trial to evaluate the protection of Xenon against spinal cord     ischemia-reperfusion injury and the potential mechanisms   "
39517|NCT02768376|"     In this study, the investigators will study spinal anesthesia for laparoscopic     cholecystectomy in comparison to general anesthesia (GA) regarding patient satisfaction as a     primary variable, intraoperative complications, postoperative analgesic requirements,     postoperative nausea and vomiting, patient hospital stay (secondary variables).   "
39082|NCT02774083|"     Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental     deterioration and preserve cognitive abilities among people aged 60 and above. The program is     an applied practicable program based on the theories of Structural Cognitive Modifiability as     well as on a Mediated Learning Experience. The program takes into consideration the unique     characteristics and requirements of the older population. The program is composed of a     variety of cognitive tasks that offer systematic activities intended to stimulate mental and     cognitive development.      Objective: To examine the influence of the Feuerstein Program on the cognitive function and     well-being of participants suffering from Mild Cognitive Impairment (MCI).      Hypothesis: The Feuerstein Program will improve cognitive abilities and functional well-being     of the participants.      Methods: Residents of retirement homes will be offered to participate in the research.     Participants will undergo cognitive and functional assessments that will be carried out on     four specific dates. The participants of the Intervention Group will participate in the     Feuerstein program using a method of mediated learning while the Control Group will     participate in a program of the Adler Institute involving activities aimed at social and     emotional development without specific cognitive skill training.   "
39083|NCT02774070|"     This study detects the presence of atlantoaxial joint affection in symptomatic versus     asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance     imaging of the cervical spine   "
39084|NCT02774057|"     Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic     inflammation limited to the mucosal layer of the colon. Anemia is a consistent clinical     feature of IBD. It is encountered in one third of IBD patients, and is the most common     extraintestinal complication of this disease. Anemia has a significant impact on the quality     of life of affected patients. Many patients with IBD frequently complain of chronic fatigue     commonly caused by anemia and this may be as debilitating to patients as abdominal pain and     diarrhea. Anemia in IBD is multifactorial, but is most commonly the result of iron deficiency     anemia (IDA) and rarely due to anemia of chronic disease (ACD). Oral iron supplementation has     been used traditionally for the treatment of IDA but studies have shown that it may result in     disease exacerbation by increasing oxygen free radicals within the lumen of the gut via the     Fenton reaction. A recent study done in University Hospitals Birmingham, United Kingdom, has     shown that treatment with oral iron results in failure to control anemia in 2 out of 3 IBD     patients, which is in part due to the side effects reported by over half of patients.     Captafer is a new iron-free oral preparation that contains a special type of oligosaccharides     from fish muscle tissue able to make the intestine absorb 3 to 5 times more iron in     comparison to the meat factor. Moreover, Captafer contains other vitamins and supplements     that improve anemia.   "
39085|NCT02774044|"     The purpose of the study is to evaluate the efficacy and safety of Cadisurf (goat lung     surfactant extract) as compared to Survanta (beractant) in the treatment of respiratory     distress syndrome in preterm neonates (with gestation of 26 to 32 weeks).   "
39086|NCT02774031|"     Low flow anesthesia (LFA) is used less than desirable, partly because one has considered that     there might be danger of underdosing of anesthesia gas and thus risk of awareness under     anesthesia.LFA has several advantages such as reducing loss of moisture and heat in the     inhaled air under anesthesia and to reduce the consumption of anesthetic gas. A few     anesthesia machines include an automatic gas control system: the Aisys machine, by GE     Healthcare (Madison, WI, USA), and the Flow-i machine, by Maquet (Sweden).      Since these machines were introduced, only a few studies have reported their functionality     and effect on gas consumption. 20 to 55% reduction of gas consumption was found. The     potential reduction may have been underestimated because in the majority of cases a FGF     higher than 1 l/min was still used.      In this study the consumption of anesthetic gas (desflurane) delivered by two different     anesthesia machines (Aisys and Flow-i) will be compared, with and without gas control     delivery systems. Gas consumption and the time needed to reach the target level of anesthetic     gas concentration will be assessed. Data needed will be collected directly from the     anesthesia machine, PICIS ( Electronic anesthesia record) and EPJ (Electronic patient     journal). The results of this study are of interest for intraoperative ventilation and of     economic and ecological interest   "
39087|NCT02774018|"     The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction     (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life     satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly     people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several     selfreport questionnaires and were assessed with Mini Mental State Examination. Participants     attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48     sessions (16 weeks) and Participants were evaluated before and after the intervention.   "
39088|NCT02774005|"     LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy     and safety of Raxone® in the long-term treatment of LHON patients.   "
39089|NCT02773992|"     Medical The Internet of Things (IoT), a recent breakthrough in communication technology,     could be helpful in improving health care delivery and saving medical costs, but regarding     pulmonary nodule management it is still at the basic understanding. Investigators adopt     Internet of things medical three plus two type pulmonary nodule diagnosis which chun-xue     Bai put forward, used a developed a mobile phone-based IoT (mIoT) platform and initiated a     randomized, multicenter, controlled trial to value clinical effectivity of Internet of     things medical three plus two type pulmonary nodule diagnosis in the management of pulmonary     nodules. In this study, at least 600 patients with pulmonary nodules (no typical symptoms,     often single, clear boundary, increased density, soft tissue shadow surrounded by lung     parenchyma with diameter ≤3 cm) will be randomly allocated to the control group, which     receives routine follow-up, or the intervention group, which receives Internet of things     medical three plus two type pulmonary nodule diagnosis management. Endpoints of the study     include: (1) The positive diagnosis rate of lung cancer in I stage; (2) 5 year disease-free     survival rate and overall survival rate; (3) direct medical costs per year. Results from this     study should provide direct evidence for the suitability of Internet of things medical three     plus two type pulmonary nodule diagnosis in pulmonary nodules patients management.   "
48161|NCT02655224|"     The purpose of this study is to evaluate the efficacy of TAK-385 40 mg administered orally     once daily for 12 weeks, compared with placebo in participants having pain symptoms     associated with uterine fibroids.   "
39090|NCT02773979|"     This phase 1, double-blinded, randomized, placebo-controlled study will enroll 36 healthy     volunteers to receive 1 of 3 regimens of PfSPZ or placebo, randomized 3:1. They will also     receive suppressive doses of chloroquine (CQ). 10 weeks post 3rd immunization (and 4 weeks     after last dose of CQ) subjects will be subjected to controlled human malarial infection. The     primary objective of this study is to 1) evaluate the safety and tolerability of escalating     doses of Sanaria PfSPZ Challenge administered by DVI on Days 3, 10, and 17 to healthy     malaria-naïve adults taking suppressive doses of CQ.   "
39091|NCT02773966|"     The objective of this randomized phase III study is to test the superiority of Kypho-IORT     compared to EBRT with regard of time to pain reduction in patients with painful vertebral     metastases. Therefore patients will receive intraoperative radiotherapy (8 Gy with Intrabeam     System/Carl Zeiss) during kyphoplasty (Arm A) or external beam radiotherapy with 30 Gy, added     in 3 Gy per fraction on a conventional linear accelerator or 8 Gy single dose (only for     international study centers, not permitted in Germany) (Arm B).   "
39092|NCT02773953|"     Improvement in CPAP adherence can be obtained by usingTelemonitoring. T4P® is a     telemonitoring unit added on CPAP device allowing to obtain a daily report of usage duration,     mask leaks, pressure and apnea-hypopnea index. The purpose of this study is to assess the     impact of telemonitoring on the delay to the first technical intervention after CPAP     titration night in CPAP-treated obstructive sleep apnea patients managed in the sleep unit.     The shortening of this delay could help to improve adherence during the first weeks of     treatment. As a secondary aim, the investigators would like to assess the impact of     telemonitoring on mean adherence during the first 3 months of treatment, which is a crucial     period.   "
39093|NCT02773940|"     The purpose of the study is to collect information on prostate tissue biopsies collected with     the ClariCore System during a radical prostatectomy procedure. The ClariCore System is     designed to improve how biopsies are taken from the prostate by using light sensors (fiber     optics) that can see changes in the tissue. The information collected from the study will be     used to develop a method to tell the difference between normal and suspicious tissue to help     guide the physician during a biopsy procedure.   "
39094|NCT02773927|"     Presence of metabolic syndrome (MetS) and its relation with insulin resistance, obesity,     dyslipidemia, systemic inflammation and cardiovascular disease is of great concern. The study     of certain adipokines such as adiponectin has demonstrated an inverse association with     insulin resistance, especially in Latin population lower levels of adiponectin have been     observed compared to other ethnic groups. It appears to be an important molecule that is     involved in limiting the pathogenesis of obesity-linked disorders and may have potential     benefits as a marker to evaluate the effect of possible interventions on the MetS components     and its complications.      Metformin is treatment of choice in patients with MetS, due to its low cost and     pharmacological comparable effects with thiazolidinediones (pioglitazone), it decreases     hyperinsulinemia, insulin resistance, free fatty acids and triglycerides, it produces as     well, a moderate weight loss, improves lipid profile and delays the appearance of diabetes     mellitus in subjects with an abnormal fasting glucose.      A second choice to lower the risks would be the addition of a fiber like inulin, a prebiotic,     since it has demonstrated metabolic benefits on lipid and carbohydrates metabolism by several     mechanisms proposed such as induction of lipogenic enzymes by glucose, production of     short-chained fatty acids, glucose-dependent insulinotropic peptide (GIP) and glucagon-like     peptide-1 (GLP-1), and growth of Bifidobacterium. A good natural source of inulin is the     agave.      It is expected that the combination of metformin plus agave inulin will produce a beneficial     impact through pharmacological synergism and that will produce changes in the pathophysiology     of MetS.   "
39095|NCT02773914|"     The present study Comprehensive Geriatric Assessment for frail older people in Swedish acute     care settings - a randomized controlled study comprises two study arms: one intervention and     one control group. The intervention Comprehensive Geriatric Assessment (CGA) for frail older     people addresses people 75 years and older who are seeking acute hospital care at the     hospital emergency department, and who are identified as frail. The CGA intervention,     including a multidisciplinary team that assesses the patients socio-demographic background,     social network, health and medical history, medications, functional status, cognitive status,     nutritional status, somatic status and psychosocial status including depression, as well as     treatment and planning for discharge and follow-up, contributes to a person-centred, and a     comprehensive assessment tailored for each person. The results of this study are expected to     optimize the implementation of future complex interventions and lead to the improvement of     the care, support and rehabilitation for frail older people with complex needs.      This study will contribute to an evidence base for full scale implementation of CGA in     Swedish hospital care. The process evaluation, aiming to provide insight into function and     consequences of the intervention, why it works or fails, is an important part of the design     that will contribute with insights into real life conditions that may be challenging in     implementing CGA. The investigators will evaluate fidelity and quality of the implementation,     clarify causal mechanisms and identify contextual factors associated with variation in     outcomes. The development of screening for frailty and CGA are potential and important tools     to identify needs of this older population, and to direct the right health care actions     towards those in most need.      The study will address the following research questions:        1. Can Comprehensive Geriatric Assessment for frail older patients in Swedish acute          hospital settings:             -  increase/maintain independence, functional status, health related quality of life               and life satisfaction?             -  increase satisfaction with health care?             -  reduce health care consumption?        2. How feasible and acceptable are the study processes and procedures of CGA from the          perspective of care givers and older persons in Swedish settings?   "
39096|NCT02773901|"     In current practice patients with a suspected increase of intracranial pressure (ICP) will     undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a     marker for ICP). A lumbar puncture is an invasive and sometimes painful procedure. Using a     new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an     acoustic signal   "
39097|NCT02773888|"     Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.     HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's     head.      HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately     monitor ICP with minimal discomfort to patients, and provide information about normal or     elevated ICP levels to the physicians.   "
39098|NCT02773875|"     This is a randomized crossover study testing the efficacy of the Fault Detection algorithms     using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with     type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three     weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized     order   "
39180|NCT02772809|"     Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked     to perform a battery of assessments to test the viability and usability of a force-feedback     robot that adapts to each individual subject's performance. Subsequently, they will be asked     to complete post-assessment questionnaires that provide feedback to the researchers on their     observations and thoughts about the therapy devices.   "
39100|NCT02773849|"     Previous multi-dose Phase I and Phase II clinical studies have demonstrated that Instiladrin     is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III     study is designed to expand those observations using a high dose of Instiladrin in patients     that are BCG Unresponsive which refers to patients with high grade NMIBC who are unlikely     to benefit from and should not receive further intravesical BCG.   "
39101|NCT02773836|"     The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco     Products Directive (TPD) within the context of FCTC ratification at an EU level. The     investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate     the psychosocial and behavioral impact of TPD implementation and FCTC implementation, through     the creation of a cohort study of adult smokers in 6 European Member States (EU MS), Germany,     Greece, Hungary, Poland, Romania, Spain; (total n=6000) in a pre- vs. post-TPD study design.      EUREST-PLUS is funded through the European Union's Horizon 2020 research and innovation     programme under grant agreement No 681109   "
39102|NCT02773823|"     The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular     health among obese schoolchildren. The intervention methods include dietary instruction and     exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids     and glucose.   "
39103|NCT02773810|"     Currently there are approximately 400 women of reproductive age enrolled in outpatient     monitoring of warfarin therapy through AMS. The investigators do not have any data on the     percentage of women who are using family planning, but anecdotally the providers report that     it is very low. The investigators believe that an educational intervention with an emphasis     on the safest and most effective methods, long-acting reversible contraception (LARC), aimed     specifically toward women with medical conditions requiring anticoagulation, combined with     on-site provision of LARC can improve uptake of these methods. Ultimately, the use of the     most effective methods of contraception will prevent unplanned pregnancy and the unnecessary     maternal morbidity and mortality associated with high-risk pregnancies in women with these     conditions.   "
39104|NCT02773797|"     A variety of medications have been used to treat the anxiety, discomfort, and fear associated     with continuous and sudden episodic breathlessness in patients with advanced respiratory     disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed     for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,     especially respiratory depression, so they frequently prescribe benzodiazepines. Recent     studies have shown that benzodiazepine use is associated with adverse respiratory outcomes in     older adults with Chronic Obstructive Pulmonary Disease (COPD). Dexmedetomidine may be an     alternative to current drug therapies for breathlessness. Dexmedetomidine produces a dose     dependent sedation, anxiolysis, and analgesia without respiratory depression or cognitive     dysfunction.      The drug can be administered intranasally (IN-DEX) to induce light to moderate sedation of     several hours duration.      The objective of the research is to assess the dose dependent safety and efficacy of     intranasal dexmedetomidine compared to intranasal saline (placebo) in clinically stable     patients with severe COPD. This will be accomplished in a staffed acute care setting with     routine vital signs monitoring and continuous pulse oximetry. Patients will be assessed     objectively and subjectively for their level of sedation by validated sedation scales.      The study is an extension of a similarly designed pilot study which did not include a placebo     comparison. Results of the study will be helpful to design additional trials with intranasal     dexmedetomidine in acutely symptomatic COPD patients, exertional dyspnea and exercise     performance, and dyspnea treatment comparisons.   "
39105|NCT02773784|"     -  This is a prospective, single-center, non-randomized, non-controlled study.        -  The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of          CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive          breast cancer. The concordance of these biomarkers between CNB and surgical specimen was          varied in previous retrospective reports. The aim of this study is to determine the          discordance of these biomarkers between CNB and surgical specimen and the influence of          making treatment strategy by the discordance.   "
39106|NCT02773771|"     Acute muscle wasting occurs early and rapidly during the first week of critical illness and     contributes substantially to weakness acquired in the ICU. Muscle wasting and subsequent     weakness is associated with delayed liberation from mechanical ventilation, prolonged     hospital length of stay, long-term functional disability, and worse quality of life.     Moreover, low muscle volume as well as ICU-acquired weakness increases the risk of mortality     in critically ill patients. Although several factors likely accelerate skeletal muscle     wasting during critical illness (e.g., immobility, inflammation, multi-organ failure), the     understanding of the underlying mechanisms remains limited and is reflected in the lack of     effective interventions to prevent the loss of muscle mass in ICU patients. To-date, there is     no known safe and effective pharmacological or nutritional intervention to attenuate the     acute loss of muscle mass in ICU patients.      Leucine is an amino acid widely regarded for its anabolic effects on muscle metabolism.     However, the concentrations required to maximize its anti-proteolytic effects are far greater     than the concentrations required to maximally stimulate protein synthesis. This has resulted     in the search for leucine metabolites that may also be potent mediators of anabolic processes     in skeletal muscle; one such compound is β-hydroxy-β-methylbutyrate (HMB). HMB is thought to     primarily facilitate protein synthesis through stimulation of mammalian target of rapamycin     (mTOR), a protein kinase responsive to mechanical, hormonal, and nutritional stimuli that     plays a central role in the control of cell growth. Randomized, controlled trials to assess     the effect of HMB supplementation on clinical outcomes in patients with chronic diseases are     limited, and even fewer studies have assessed its effects on skeletal muscle metabolism     during critical illness. Furthermore, despite compelling preclinical evidence, the exact     mechanisms underlying the effect of HMB supplementation during acute catabolic stress in     humans is not well defined. Therefore, the investigators goal is to study the impact of early     HMB supplementation on skeletal muscle mass in ICU patients and to explore the mechanisms by     which HMB may exert its effects on skeletal muscle metabolism during critical illness.   "
39118|NCT02773615|"     Background In the differential diagnosis of unstable angina versus non-anginal chest pain, an     exercise test is often the modality of choice for further investigation. However, in a     substantial number of patients exercise testing is less informative, because of insufficient     exercise capacity or pre-existing ECG-abnormalities. In patients with low pretest probability     of coronary artery disease (CAD), Coronary CT angiography (CTA) has an excellent negative     predictive value, but in patients with an intermediate or high pretest probability of CAD     estimation of the hemodynamic significance of a stenosis has only limited specificity. CT     perfusion (CTP) is a new method looking at myocardial perfusion during vasodilative stress     with a sensitivity, specificity, positive predictive value and negative predictive value of     respectively 81%, 93%, 87% and 88%, whereas radiation is limited to a maximum of 5     millisievert (mSv).      Aim It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a     feasible and safe investigational workflow in patients with unstable angina or nonanginal     chest pain in the emergency department.   "
39108|NCT02773745|"     With aging population, total knee arthroplasty is performed with increasing frequency.     Although the surgery is successful in general, significant number of patients suffers     persistent pain and disability. Traditional risk assessment tool have been focused on single     organ systems. Our investigators have found that mobility, assessed by the Mobility     Assessment Tool short form (MAT-sf), is a simple and accurate method to predict postoperative     outcome, including length of stay, postoperative complications, and nursing home placement     for older patients. Prehabilitation is the process of enhancing a person's functional     capacity to withstand an incoming stressor. Although multiple studies have tested     prehabilitation before joint replacement surgery, results have been mixed. The investigators     hypothesize that patients with limited mobility are most likely to benefit from     prehabilitation. The investigators plan to use individualized aquatic exercise as a     prehabilitation tool to enhance compliance; the resistance of water strengthen muscle and     increasing energy expenditure; the buoyancy of water provides environment where the joints     are not weight bearing. The aims of the study are: 1) To evaluate the feasibility of     prehabilitation using 6-8 weeks of aquatic exercise in 40 geriatric patients who are     scheduled for total knee arthroplasty for osteoarthritis; 2) To examine the effects of 6-8     weeks of aquatic exercise on mobility, pain, stiffness, physical function, cognitive function     and depression; inflammatory markers and 3) To estimate the effect of prehabilitation on     postoperative outcomes. The investigators plan to enroll 40 patients age >50, who are     scheduled for elective primary total knee replacement. Investigators will screen patients in     the Preoperative Assessment Clinic and enroll patients who have decreased mobility, measured     by MAT-sf. Patients will be randomized into either a prehabilitation group or a usual care     group. All the participants will undergo extensive assessment on their pain, stiffness, and     physical function, depression, balance and cognitive function using the Western Ontario and     McMaster Universities Osteoarthritis Index (WOMAC), the expanded Short Physical Performance     Battery (eSPPB), and Montreal Cognitive Assessment (MoCA). Serum inflammatory markers will be     assessed at the baseline. The prehabilitation group will undergo 6-8 weeks of individualized     aquatic exercise in a heated pool (60 min/session, 3 times per week). Aquatic equipment maybe     used to challenge balance and trunk stabilization. All participants will be reassessed     immediately before surgery and 4 weeks after the surgery using WOMAC, eSPPB, MoCA and MAT-sf.     Serum inflammatory markers and body composition will be reassessed at the same time points.     The primary outcome of interest is will be postoperative complications, length of stay,     Intensive Care Unit length of stay, and institutionalization. If successful, investigators     will have sound pilot data for several critical health outcomes with which to support an     external proposal for a larger-scale study.   "
39109|NCT02773732|"     The purpose of the first part of this study is to establish the maximum tolerated dose (MTD)     of oral ciprofloxacin when given in combination with a fixed dose of oral etoposide in     patients with resistant acute myeloid leukemia (AML). The purpose of the second part of this     study is to determine if the established dose of oral ciprofloxacin in combination with oral     etoposide is effective in the treatment of patients with resistant AML.   "
39110|NCT02773719|"     Traditionally, healers are willing to look after, two out of three French citizens have     already appealed to them at least once during their lives. Many healers in good faith are     exercising their magnetism as a gift often inherited from elders. Now, they create interest     of doctors who do not hesitate in some cases to ensure their cooperation, to implicitly     recognize their mysterious talents. Some serious studies have examined these practices:     Several studies have been conducted on the influence of biofield therapies in pain,     depression and fatigue in cancer disease. The investigators propose a study of the effect of     magnetism on the wart disease whose cure is objectively assessable.      Sixty-two subjects in total would be included, comparing 2 proportions observed: the     proportion of healing in the group treated with a real biofield therapist (recognized and     affiliated to the National Group for Alternative Medicine in France) to the proportion of     healing in the group treated with a fake biofield therapist (someone assessed as not having     capacity to magnetize). The fake biofield therapist, placebo, has been trained to replicate     gestures during a training validated by an independent recognized biofield therapist.      If the results are in favor of magnetism, this pilot study would encourage additional     investigations to determine whether the practice of magnetism may be a paramedic     specialization.   "
39111|NCT02773706|"     The DECADES trial seeks to determine the comparative effectiveness of specialist-centered     management of anxiety and depression vs. an imbedded and automated psychology referral for     all subjects who screen positive for anxiety or depression.   "
39112|NCT02773693|"     The primary objective of the current study is to determine if providing cognitive-behavioral     therapy of Insomnia and nightmares (CBTin) and Cognitive Processing Therapy of PTSD (CPT)     results in greater PTSD and sleep symptom reduction than CPT only. A secondary objective is     to determine if the sequencing of CBTl&N before or after CPT results in differential effects     on PTSD and sleep symptom reduction.   "
39113|NCT02773680|"     Current EIT analyses are based on the assumption of a circular thorax-shape and do not     provide any information on lung borders. The aim is to obtain the body and lung border     contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds     of anthropometric data (gender = male; height; weight) for calibration of more realistic EIT     reconstruction models.   "
39114|NCT02773667|"     Correlation analysis between estimated renal function and biological half life of 131-I     during radioiodine treatment of patients with differentiated thyroid cancer.   "
39115|NCT02773654|"     The purpose of this study is to determine the ability of a mobile clinical application to     reliably and accurately track scapular motion in people with asymptomatic and symptomatic     shoulders. The ability to accurately and reliably measure shoulder position clinically is an     important first step in choosing the best treatment techniques to treat shoulder movement     dysfunction. Therefore, the primary objectives of the study are:        1. To determine the inter- and intra-rater reliability of shoulder joint position          measurements in symptomatic and asymptomatic subjects, by using a mobile application,          with and without use of a handle for a smartphone        2. To determine the validity of the shoulder joint position measurements measurements as          described above.   "
39116|NCT02773641|"     Women with provoked vestibulodynia (PVD) suffer from severe dyspareuni and often present a     hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale     for the study is that for women with PVD who don't succeed to restore the function of the PFM     by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the     high muscle tonus and thus possibly reduce the coital pain.   "
39117|NCT02773628|"     Eviction methods for dust mite allergy have been evaluated in asthma control in a recent     Cochrane meta-analysis. None have shown efficacy on asthma control and there are not     recommended. The purpose is to evaluate the efficacy of a new commercialized system (Acar'Up)     to decrease dust mite load and to assess its impact on the possibility to perform inhaled     corticosteroids step down in stable asthmatics.   "
39155|NCT02773134|"     Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients     with lumbar degenerative conditions with the aim of improving pain relief and quality of     life. However, there is a lack of evidence on the indication for postoperative bracing, as     surgeons choose to use braces mainly based on their experience and training.      The aim of this study is to investigate whether wearing a brace after PSIF can improve pain     relief and quality of life (QOL) 6 weeks and 3 months after surgery.   "
39120|NCT02773589|"     Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower     esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique     allowing to cure this pathology. In this study, investigators are using a new endoluminal     technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy).     This technique does not require any cutaneous incision.      Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by     the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context,     the introduction of the POEM technique seems to be an original approach and a natural     evolution to a new generation of surgical endoscopy.   "
39121|NCT02773576|"     A one year, open-label, study to evaluate the safety and tolerability of risperidone implants     as a maintenance treatment in patients with schizophrenia   "
39122|NCT02773563|"     The insufflation of air in the viscera is indispensable during endoscopy. However, the     distension of the bowel that follows is often the cause of abdominal discomfort.      Carbon dioxide (CO2) has been widely used for insufflation in endoscopy. CO2 insufflation is     demonstrated in the literature to cause lower abdominal discomfort as it is quickly     reabsorbed by the body.      Endoscopic ultrasonography (EUS) is a method in which you associate the endoscopic view and     the ultrasound vision obtained from the inside of the viscera.      The diagnostic accuracy of EUS is undermined by the visual artifacts caused by the presence     of air between the probe and the organ to be studied.      Although the use of CO2 is already widely applied by many endoscopists, there are no studies     to date concerning the use of CO2 during EUS from the point of view of the abdominal     discomfort related to the procedure and/or the quality of the images obtained.      The main purpose of the study is to assess whether the insufflation of CO2 results in a     reduction of discomfort of the patients undergoing EUS. The study design is observational     because no randomization or other interventions are planned; participants will be assigned to     either air or CO2 insufflation according to the endoscopic room equipment (one room is     equipped with CO2 insufflation while another endoscopic room is equipped just with air     insufflation) and the results of the two groups will be compared. Among the secondary goals     the investigators want to evaluate whether insufflation of CO2 is associated with a reduction     in the dose required for patients sedation. Finally, the investigators want to clarify     whether the use of CO2 is able to produce less visual artifacts than air and thus improve the     quality of EUS images.   "
39123|NCT02773550|"     This clinical trial is a multicenter, cohort, with one arm to study the SLP to 18 months of     Velcadito scheme (velcade 1.0 mg / m2 administered over two days with melphalan and     prednisone) in patients with MM diagnosis again higher 75. After completion of the protocol     patients were still approximately every two months, in clinical practice, to observe the     survival and answers to other treatments. All the scans are part of the normal routine. The     realization of diagnostic tests and drug treatment will be performed regardless of the     patient's participation in the study as part of routine clinical practice All patients who     meet criteria. The incidence of MM age-adjusted to cover the participating hospitals is     estimated in 44 patients.      Patients will receive a course of 4 weeks duration of Melphalan / Prednisone / Velcade     consist in Melphalan, 9 mg / m2 orally daily 1-4 and Prednisone 60 mg / m2 orally on days 1     to 4, in combination Velcade with a dose of 1.3 mg / m2 sc twice weekly (days 1, 4, 8, 11),     followed by 2 weeks of rest (cycle duration of 4 weeks) and seven four-week cycles duration     of melphalan / prednisone / Velcade consist in Melphalan, 9 mg / m2 orally on days 1 to 4 and     prednisone, 60 mg / m2 orally on days 1 to 4, in combination with Velcade, at doses of 1, 0     mg / m2 sc (days 1, 4).      Melphalan and Prednisone will be dispensed for oral administration. The Melphalan should be     administered in a single two hours separately taking any food and prednisone be taken in the     morning with or immediately after a meal. The amount in mg will be calculated based on the     body surface, to be calculated on day 1 of each cycle. Velcade for administration, calculated     on day 1 of the cycle will be the same dose throughout the entire cycle. If a patient     experiences a gain or loss of remarkable weight within the cycle, the dose to be administered     will be recalculated based on the new body surface. The appropriate amount of Velcadeserá     dispensed in a sc injection. Velcade dose between two leave at least 72 hours   "
39124|NCT02773537|"     The primary aim of this pilot study will be to develop a clinically meaningful,     patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of     different strategies for achievement of the ideal balance between analgesia and functional     mobility following total knee arthroplasty (TKA).   "
39125|NCT02773524|"     Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no     established standard treatment following failure of first and second line chemotherapy.     Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase inhibitor     (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and     KIT) receptor tyrosine kinases, and has shown activity in other solid tumours. Regorafenib     was shown to prolong PFS across all regions/subgroups in INTEGRATE I The general aim of this     study is to determine if regorafenib improves overall survival in refractory AGOC.   "
39126|NCT02773511|"     The study evaluates the effectiveness of surgical or non-surgical treatment for children type     1 humeral condyle fracture.Half of the participants receive surgical treatment and the other     half receive non-surgical treatment   "
39127|NCT02773498|"     To compare motile sperm extraction rate between microTESE and conventional TESE in 18-50     years-old men with non obstructive azoospermia.   "
39128|NCT02773485|"     The study evaluates impact of high dose radiation on overall survival in patients with     unresectable nonmetastatic cholangiocarcinoma. The study randomizes patient between systemic     chemotherapy alone and systemic chemotherapy and high dose radiation   "
39156|NCT02773121|"     The goal of this research study is to examine whether an intervention to increase physical     activity using a body-worn sensor affects cognitive (thinking) processes.   "
39129|NCT02773472|"     A multimodal approach for management of post-operative pain is used to improve analgesia,     minimize side effects, and improve recovery. Nevertheless, opioid analgesics and intravenous     patient controlled analgesia remains the mainstay of postoperative analgesia after colorectal     surgery. Opioids are associated with various side effects such as nausea, vomiting, sedation,     dizziness, respiratory depression, urinary retention and reduced bowel movement. These side     effects are unpleasant and lead to prolonged recovery.      Use of non-pharmacological analgesic techniques may improve postoperative pain control and     reduce opioid consumption. Acupuncture has been used for over 3000 years in China for     treatment of pain and various other conditions. Acupuncture and related techniques are simple     and safe. There is evidence that acupuncture can reduce postoperative pain intensity, opioid     consumption, and opioid related side effects.   "
39130|NCT02773459|"     This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated     advanced biliary tract cancer, and to explore the predictive biomarkers for future     large-scale clinical trials using this combination.   "
39132|NCT02773433|"     The primary aim of this research is to determine the feasibility of conducting a randomized     controlled trial comparing two ventilation modes in patients admitted to the ICU who require     mechanical ventilation. The investigators plan to include patients on mechanical ventilation     with low support (PaO2/FiO2 ratio > 200, FiO2 < 0.5 and PEEP < 8) for a period no longer than     48 hrs. There are a number of potential barriers to enroll patients in the study. Importantly     patients will have to be enrolled within 48 hours from the time they meet inclusion criteria.      The secondary aims are to determine the impact of proportional assist-ventilation (PAV)     versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free     days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic     medications, use of antipsychotic medications, length of stay in the intensive care unit and     hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of     patients.   "
39133|NCT02773420|"     Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar     System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective     pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients     previously.      Methods: Patients seen at a colorectal clinic in a single institution with grade I-II     hemorrhoids are offered to participate in a prospective pilot trial. The HET device is a     modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar     energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of     hemorrhoids are treated with 2 heat energy applications per column. The primary outcome is     the treatment effect on hemorrhoid symptoms of bleeding, pain, prolapse, itching, and     soiling. This is measured with a patient completed questionnaire documenting each symptom's     frequency from 0 to 3 (i.e. 0 is < 1x/month; 3 is daily) before therapy and at 3 weeks and 6     month follow-up. Post-treatment pain scores were recorded using the visual analog scale     (VAS).   "
39134|NCT02773407|"     The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best     empirical treatment for undifferentiated febrile illness in Nepal   "
39135|NCT02773394|"     The purpose of the study is to describe: 1) the clinical profile, past and current management     of participants with hepatitis C in Brazil reference centers; 2) the current situation about     demographics characteristics, liver disease progression and clinical outcomes in Brazilian     Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral     treatment without sustained virological response (SVR).   "
39136|NCT02773381|"     This trial is conducted in Europe. The aim of this trial is to investigate the effect of oral     semaglutide compared with placebo on postprandial glucose and triglyceride metabolism, energy     intake, appetite sensations and gastric emptying in subjects with Type 2 diabetes   "
39138|NCT02773355|"     This trial is conducted in North America. The aim is to investigate timely detection of     pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions     possibly or probably related to Saxenda® in Mexican patients.   "
39139|NCT02773342|"     The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the     world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in     the last decade, the outcome of patients with IPA is still unsatisfactory and needs     improvement. Particularly, recent developments in diagnostic imaging, including introduction     of high-resolution computed tomography (CT) into standard procedures, made a place for     improvement of diagnosis of IPA.      Computed tomography of the chest is the optimal, recommended imaging procedure for diagnosis     of pneumonia in febrile neutropenic patients and it is significantly superior to conventional     chest X-ray. However, the method is associated with some difficulties mostly due to the broad     spectrum of pathological findings in patients with IPA and their evolution over time. This     has been described in retrospective studies on relatively small groups of patients.     Prospective studies on larger populations are still missing, as well as studies on     combination of different diagnostic modalities e.g. diagnostic imaging and microbiology.      We recently published the results of the clinical trial: A Phase II Dose Escalation Study of     Caspofungin in Patients with Invasive Aspergillosis which used caspofungin doses of 70 to     200 mg daily for the first line treatment of IPA. The maximum tolerated dose was not reached,     but response rates were impressive with complete plus partial responses accounting for 54.3%     and overall mortality at 12-week follow-up as low as 28.3%. There was a tendency towards     higher doses yielding higher response rates.      For the majority of these patients we obtained serial chest CT. So, for the first time a     patient population is at hand, in which the kinetics of infiltrates over time can be     described.      The main objective is to describe the pathological findings in chest CT performed     sequentially in IPA patients while receiving effective antifungal therapy. The specific     objectives are:        1. Characteristics of pathological findings in sequential chest CTs             -  To describe the pathological findings (e.g. halo sign, air crescent sign and air               consolidation) in sequential high resolution computed tomogrphy (HRCT) examinations             -  To calculate the incidence of individual pathological findings in sequential CT               examinations             -  To calculate a total volume of fungal infiltrates in sequential CT examinations        2. Correlation of pathological findings in sequential CT with corresponding white blood          count (WBC) and absolute neutrophil count (ANC)             -  To correlate the appearance or disappearance of individual pathological findings               with WBC and ANC             -  To correlate the volume of fungal infiltrates in sequential CT examinations with               WBC and absolute neutrophil count        3. Correlation of pathological findings in sequential CT with the serum galactomannan index             -  To correlate the appearance or disappearance of individual pathological findings               with the serum galactomannan index             -  To correlate the volume of fungal infiltrates in sequential HRCT examinations with               the serum galactomannan index        4. Correlation of pathological findings in sequential HRCT with outcome of IFI             -  To correlate the appearance or disappearance of individual pathological findings               with outcome of IFI             -  To correlate the volume of fungal infiltrates in sequential HRCT examinations with               outcome of IFI   "
39157|NCT02773108|"     Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric     hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic     comorbidities in psychiatric patients population and the general Croatian population.   "
39140|NCT02773329|"     Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in     sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural     control and high fall risk. This study will investigate the acceptability and effect of an     interactive motor adaptation balance training program based on wearable sensors for improving     balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN will be     recruited and will be randomized to either intervention (IG) or control (CG) group and     followed for 6 months. The intervention group will take part in a 6-week balance training     program twice per week in either their home or in clinic (based on subject preference) under     the supervision of a qualified research staff member. This intervention includes interactive     game-based balance training including repetitive weight shifting and virtual obstacle     crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot     and ankle position and allowed perception of motor-errors during each motor-action. The     control group will be instructed to complete a supervised foot and ankle exercise without     using sensor technology. Changes in balance, gait, and physical activity, and number of falls     will be compared pre- and post-intervention, as well as 3 and 6 month post intervention.     Investigators hypothesize that patients receiving sensor-based exercise training will benefit     more compared to group receiving conventional non-technology home-based training in terms of     improving functional performance and reducing falls.   "
39141|NCT02773316|"     A study to assess bioavailability of a single dose of MR902 and to assess the effect of food     on absorption   "
39143|NCT02773290|"     The objective of this study is to evaluate the efficacy of romiplostim administered once     weekly to Aplastic Anemia (AA) patients with thrombocytopenia refractory to or ineligible for     immunosuppressive therapy in Japan and Korea.      Safety and pharmacokinetics of romiplostim after repeated administration will also be     assessed.   "
39144|NCT02773277|"     Due to its localization in the cerebello-pontine angle, the vestibulo-cochlear nerve is at     risk to damage during surgery performed nearby. In most cases, peripheral-cochleovestibular     hypofunction recovers over the following weeks as the mechanism of damage is rather     demyelination than axonal damage. The rate, intensity and extent of recovery of such     perioperative peripheral-vestibular damage is not known.   "
39145|NCT02773264|"     This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography     of Patients referred to our institution to assess soft tissue and organ lesions. All patients     will undergo next to the clinical indicated conventional US-examination, US Elastography     after informed consent. After completion of these three examinations, the participation in     the study is completed.   "
39146|NCT02773251|"     To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose     following laparoscopic pelvic surgery (radical prostatectomy).   "
39147|NCT02773238|"     This phase II trial studies how well positron emission tomography (PET)/computed tomography     (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving     radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer.     PET/CT imaging mid-way through treatment may be able to accurately show how well radiation     therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the     lung tissue are healthier than others. Based on the result of the imaging, treatment     adjustments may be made to the radiation therapy to improve survival and decrease toxicity.   "
39148|NCT02773225|"     The aim of this study is to improve treatment of Moderate Aplastic Anemia (MAA) by evaluating     the safety and efficiency of Eltrombopag as a new treatment option in patients with therapy     requiring MAA.   "
39149|NCT02773212|"     The purpose of this study is to examine anhedonia as a potential moderator of treatment     outcomes for Cocaine Use Disorder (CUD). Specifically, this study will investigate how     anhedonia affects outcomes in contingency management (CM) treatment for CUD and whether     anhedonia mediates the effects of adjunctive treatment with a dopaminergic (DAergic) drug,     d-amphetamine, on outcomes in CM for CUD, as well as investigate the contribution of     anhedonia to overall CUD severity.   "
39150|NCT02773199|"     This study compares differences in hemodynamic ve ECG parameters of patients undergoing     urological or orthopedic surgery under spinal anesthesia. First group will comprise of     patients undergoing surgery in the morning hours; thus with a standard fasting duration (8     hours), and the second group will comprise of patients undergoing surgery afternoon; thus     having a prolonged fasting duration (>12 hours).   "
39151|NCT02773186|"     The main objective of the present study was to evaluate whether cerebral oxygen saturation is     associated with an increase of NPOBC in pediatric patients undergoing major surgery.   "
39152|NCT02773173|"     The purpose of this study is to assess the post-operative recovery quality of the     Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus     standard therapy using a quality validated scale of postoperative recovery of their stay in     the Post-Anaesthesia Recovery Unit.   "
39153|NCT02773160|"     A large subgroup of patients with chronic non-specific low back pain have motor control     impairments. During motor control exercises, different forms of external feedback can be used     to support training. This randomized controlled trial will investigate the effectiveness of     different forms of external feedback during the learning phase of a motor control task for     the lumbar spine in healthy subjects and patients with chronic non-specific low back pain     (CNSLBP). Both healthy subjects and patients with CNSLBP will be randomized into three     groups: one group will receive feedback from motion sensors, one group from a mirror and one     group will receive no feedback (control group). A single session intervention with     measurements at baseline and immediately post-intervention will be used.   "
39154|NCT02773147|"     The purpose of this study is to investigate if B vitamin substitution have effect on NFL     (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected     individuals with increased plasma homocysteine   "
39659|NCT02766517|"     This is a study of participants with a diagnosis of migraine who completed another clinical     trial known as I5Q-MC-CGAB (CGAB) (NTC02163993). In CGAB, participants received either     LY2951742 or placebo. This study will evaluate how certain biomarkers may be related to the     participant's response in CGAB. The study will last about five days.   "
39158|NCT02773095|"     Countries throughout the world are facing a growing non-communicable disease (NCD) burden. In     developing countries, medicines to treat NCDs are often difficult to access or too expensive     for many households. Novartis/Sandoz has recently launched Novartis Access, an initiative to     subsidize a basket of NCD medicines sold to purchasers in program countries and delivered     through the public and non-profit health sectors. This study will evaluate the impact of     Novartis Access on the availability and price of NCD medicines at health facilities and     households in Kenya, the first country to receive the program.   "
39159|NCT02773082|"     There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive     behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the     alternative approach or a combination of the two. A rarely used third therapy approach,     appropriate for only the most severely afflicted and treatment resistant patients, is     neurosurgical ablation of certain brain regions involved in mood and anxiety. The     neurosurgical ablation procedures are irreversible in nature, and involve the destruction of     specific volumes of brain tissue through various controlled means.      Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a     combination of the first two procedures and capsulotomy. DBS therapy is an alternative to     neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic,     severe OCD which has proven resistant to primary pharmacological and/or behavior therapy     options.      Results from 26 severe, treatment-resistant OCD patients treated with DBS at four     collaborating centers, three in the US, and one in Europe are summarized in great detail in     pages 12-22 of the provided/attached Reclaim Summary of Safety and Probable Benefit.   "
39160|NCT02773069|"     The proposed Church Bridge intervention project will provide an innovative, evidence-based     and technology supported, health intervention model for Southern, African American, and rural     populations who continue to be disparately burdened by obesity and associated co-morbidities     (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50     years of age) with families, the project will contribute to the long-term reduction of     preventable chronic disease and related health care costs for the public.   "
39161|NCT02773056|"     The primary objective of this clinical trial is to determine if the Dynamic Socket and     Sub-Ischial alternative interface designs improve socket comfort, residual limb health,     increase function and be preferred over the standard of care Ischial Ramus Containment (IRC)     interface for the military and veteran living with transfemoral limb loss.   "
39162|NCT02773043|"     The proposed study is to validate a non-invasive imaging technique to evaluate the myocardial     perfusion reserve in comparison with a validated invasive technique, the measure of coronary     flow reserve (CRF) with thermodilution.   "
39163|NCT02773030|"     This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to     determine the maximum tolerated dose of CC-220 when administered as monotherapy and in     combination with dexamethasone. The study will consist of an escalating dose-escalation     portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT)     and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose     (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).   "
39164|NCT02773017|"     Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and     inhibition of sympathetic nerves and other effects. Because of its minimal impact on the     respiratory , currently it was more and more widely used to sedate patients undergoing     regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected     by age, and current studies with regard to the effects of age on dexmedetomidine     pharmacodynamic are rare. This study was designed to explore the right DEX dose of different     female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with     combined spinal and epidural anesthesia for sedation,which is monitored by the     Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of     sedation for patients is also investigated.   "
39165|NCT02773004|"     The trial population of this study is composed of women aged more than 18, who have developed     a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive     breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard     assessments.      Obtaining material for test is at no risk as done from the surgery material. Tumor molecular     EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast     cancer related genes and will provide important prognosis indications. Clinical validation     studies have demonstrated that molecular assays are useful for stratifying patients into risk     categories and helpful in making clinical treatment decisions in ER+/node-negative breast     cancer patients.   "
39166|NCT02772991|"     In recent years, a large number of studies have been conducted on how to improve the     treatment of patients in the Emergency Room (ER) complaining of chest pains. Great advances     have been achieved recently regarding diagnostic methods aided by coronary CT angiopraphy     (CCTA) and high-sensitive troponins. However, various questions about these methods still     remain obscure and there is no effective comparison between them in patients with     intermediate risk. The aim of the study is to evaluate the sensitivity and specificity of     high sensitivity troponins in the detection of coronary artery disease in patients with chest     pain and the intermediate probability of ACS compared with CCTA.   "
39167|NCT02772978|"     This study deals with how people decide between rewards of different value. We want to     understand how the brain's dopamine system impacts this kind of decision making. We will use     a medication, tolcapone, which can temporarily affect the dopamine system.   "
39168|NCT02772965|"     The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF     therapy is more effective than treatment with anti-TNF therapy alone in inducing and     maintaining steroid-free remission for children with Crohn's Disease.   "
39177|NCT02772848|"     The study objectives are described below:        1. Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but          not to exceed a total of 550 ml of whole blood per subject from a minimum of 60 healthy,          premenopausal subjects. Specimens will be used to determine a reference range for          estradiol, FSH, LH, and progesterone assays, used as an aid in the assessment of          fertility in adult, premenopausal women.        2. To store any remaining specimens for use in future assay development and to evaluate as          yet undetermined assays for the development of IVDs, including additional estradiol,          FSH, LH, and progesterone assays.   "
39169|NCT02772952|"     Objective: To compare short-term and medium-term effectiveness of a multimodal program that     integrates a program of therapeutic exercise, medication review, adequacy of diet and health     education, compared with standard medical practice in improving neuromuscular and     physiological status on frail elderly. Another aim is to analyze the maintenance of these     effects by monitoring long-term (12 months) from the start of the intervention.      Design: Randomized controlled trial Scope / Study subjects: recruited frail elderly in Basic     Health Zone of Malaga. Methods: The subjects to be included in the study (after meeting     inclusion / exclusion) will be randomized into two groups: a control group whose intervention     will be to review medication + adequacy of diet + health education (physical activity     recommendation (within a comprehensive advice on healthy lifestyles) and an experimental     group whose intervention will be a Multimodal Intervention: therapeutic exercise + review     medication + adequacy of diet + health education program.      Sociodemographic, Clinical and monitoring Variables will be collected at baseline. Moreover,     tracking variables will be collected at 2 and 6 months after starting the intervention and at     3 and 6 months after the end of the intervention (monitoring).      The monitoring variables that will be measured are: BMI , general health, fatigue,     brittleness, Motor Control, Attention - Concentration - Memory, Motor Memory , spatial     orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and     metabolomic variables.      One descriptive analysis of the sociodemographic variables of the participants will be     performed. Further the change on the variables intra-subjects (pre-post intervention) and     inter-subjects (experimental group vs control group) will be calculated. For the     intra-subject analysis will be performed a ANOVA-one factor analysis. The intersubject     outcome variables will be compared between the two groups in each moments of data collection,     using the student t-test or Wilconxon (depending of the sample distribution). The level of     significance was set at P ≤ 0.05.   "
39170|NCT02772939|"     This trial is designed to establish invasive and non-invasive measures of arterial stiffness     as potential predictors of treatment response to renal sympathetic denervation   "
39328|NCT02770846|"     The purpose of this prospective randomized clinical study was to compare implant survival,     patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate     loading (IL) and delayed loading (DL) of single dental implants after 1,3 and 5 years of     follow-up.   "
39171|NCT02772926|"     Several mechanisms have been implicated in the pathophysiology of the complications of     diabetes mellitus (DM), one of them is the formation and accumulation of a heterogeneous     group of compounds called advanced glycation end products (AGEs). The interaction of these     compounds with their receptor, the receptor for advanced glycation end products (RAGE)     triggers several signalling pathways which will lead to increase in inflammatory molecules     and enhanced reactive oxygen species. In addition, to the membrane receptor RAGE, there are     two soluble forms, the soluble RAGE (sRAGE) and the endogenous secretory RAGE (esRAGE), these     soluble receptors are capable to bind AGEs and block the AGE-RAGE axis. It has been observed     that in diabetes the needs of thiamine are increased, and it could be an inhibition of the     pentose phosphate pathway (thiamine is an essential cofactor in this pathway) and activation     of other metabolic pathways among them AGEs formation. It has been proposed that     supplementation of benfotiamine could decreased the risk of micro and macrovascular     complications, and this could be in part because a decreased in the formation of AGEs. For     this reason, the objective of this study was to evaluate the effect of benfotiamine on AGEs     and its soluble receptors (sRAGE) in patients with type 2 diabetes.      The specific objectives in the current study are:        1. To evaluate and compare clinical and anthropometric characteristics in type 2 DM          patients with and without benfotiamine treatment.        2. To evaluate and compare in type 2 DM patients with and without benfotiamine treatment          the following biochemical parameters: total AGEs, Carboxymethyl-lysine (CML), sRAGE,          glucose, hemoglobin A1c, lipids (total cholesterol, C-HDL, C-LDL, and triglycerides).        3. To evaluate and compare dietary data such as dietary AGEs and macro and macronutrients          in type 2 DM patients with and without benfotiamine treatment.      Type of study: This is a randomized, controlled, double-blind clinical trial      Methods 34 patients will be recruited, 17 per group. After signing the inform consent     subjects will be assessed for inclusion criteria. Subjects meeting the inclusion criteria and     those whom accept to participate will be randomized to receive either a placebo or     benfotiamine treatment for 12 weeks.      At the end of the 12 weeks all the basal assessments will be repeated.   "
39172|NCT02772913|"     Acute mesenteric ischemia is a life-threatening condition characterized by high mortality if     unrecognized early. This multicenter retrospective observational study will review the     emergency departments's (ED) notes of all patients discharged from hospital with a diagnosis     of acute mesenteric ischemia in 2014-2015 comparing it with those admitted to the ED for     abdominal pain in the same timeframe.   "
39173|NCT02772900|"     Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial     dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO     bioconversion, which may promote beneficial effects on vascular health. The present study     evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function, arterial     stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly     individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial     flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ),     augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep),     arterial compliance (AC), muscle oxygenation and function were measured 90 min after     interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood     pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after     interventions.   "
39174|NCT02772887|"     The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks     provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma     L-arginine/ADMA ratio, lower maternal blood pressure and increase maternal levels of     placental growth factor (PlGF).   "
39175|NCT02772874|"     Fecal incontinence (FI) is clinically subtyped as urge FI and passive FI based on symptoms,     however the pathophysiologic significance of this subtyping is not known. FI is commonly     encountered in women with pelvic floor disorders. This study aims to compare characteristics     of clinical severity, quality of life, anatomy, and physiology of urge FI versus passive FI.     Urogynecology patients greater than age 18 with FI at least monthly over the last 3 months     will be recruited for participation. Participants will be divided into urge FI subtype and     passive FI subtype. Participants will complete validated questionnaires on clinical severity     and quality of life, both as related to FI and general heath. Participants will undergo     pelvic examination, endoanal ultrasound and anorectal manometry for evaluation of anatomic     and physiologic pathology. Results between both groups will be compared. The investigators     hypothesize that clinical, anatomic, and physiologic characteristics differ between     urge-predominant fecal incontinence and passive-predominant fecal incontinence in women with     pelvic floor disorders.   "
39176|NCT02772861|"     There are many forms of small bowel disease but their direct consequences on small bowel     function are often very hard, if not impossible, to establish. It would be helpful if there     was a reliable blood test to find out how well cells in the intestine are working. The amino     acid citrulline is produced mainly by these cells, and therefore holds promise as a     biological marker. Some previous studies have shown that fasting citrulline gave a good     indication as to how many intestinal cells were present. However, other authors have not been     able to confirm this.      Most of the citrulline in the blood is derived from another amino acid, glutamine, in a     metabolic process that occurs in the intestinal cells, and most of the remainder comes from     another amino acid, arginine. A further potential marker of intestinal cell function is the     amino acid 3-methylhistidine. It is possible that a dynamic test, which incorporates time for     conversion from one amino acid to another in the intestinal cells, might perform better.      The investigators therefore propose a study of oral glutamine, arginine, and     3-methylhistidine compared with citrulline itself or placebo (glucose) as it is hypothesized     that these might increase the amount of citrulline more reproducibly. An initial study in     healthy subjects is required to establish whether this is true, and if so to provide a normal     range prior to investigation of patients who have or who might have the short bowel syndrome,     and in whom the test would be clinically useful.      In this study, the subjects will take each of the amino acids and placebo in random order.     Between each 6 hour-long visit the subjects will have at least one week where they are     independent of the research team and during which they can behave normally. During each visit     subjects will have a sequence of blood samples from an in-dwelling venous cannula, taken     before and over 6 hours after a single small oral dose of that day's amino acid given as a     small volume drink. Urine will also be collected for amino acid assay.   "
39181|NCT02772796|"     This study is to aid the development for the use of SENS-218 outside its marketed therapeutic     indications. SENS-218 is available in Asia and is marketed as an anti-emetic (Anti-sickness)     drug often prescribed after exposure to chemotherapy. Chemotherapy exposure can often induce     nausea and/or vomiting.      The study only involves the one drug, referred to as SENS-218 in this study. The purpose of     the study is to support the development of use of SENS-218 in non-Asian population.      The key objective of this study is to identify the pharmacokinetic (PK) parameters of the     drug in healthy Caucasian population. The PK refers to what the body does to the body, for     example, how quickly the drug is absorbed into the blood stream.      The population who are eligible to take part in the study are healthy male and female,     non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at     Simbec.      Participation in the trial will last for about 3 weeks (from first screening visit to final     end of study visit).   "
39235|NCT02772081|"     This study will compare the administration of porcine surfactant (poractant alfa, Curosurf®)     through a less invasive method (LISA) using a thin catheter (CHF 6440) during non-invasive     ventilation (NIV) (CPAP, NIPPV, BiPAP) with an approved conventional surfactant     administration during invasive ventilation and rapid extubation in terms of short term and     mid-term safety and efficacy in spontaneously breathing preterm neonates with clinical signs     of respiratory distress syndrome (RDS).   "
39182|NCT02772783|"     Processed carbohydrates cause rapid changes in blood sugar and have been associated with     overeating and obesity. We have shown that test meals high in processed carbohydrate affect     brain areas involved in addiction, craving and overeating. It is unknown whether the changes     in blood sugar or the associated higher insulin levels mediate this brain activation and its     likely adverse effects.      Answering this question is important for patients with type 1 diabetes who have elevated     risks of obesity and disordered eating: If blood sugar is the causal mechanism, optimal     insulin coverage should be protective. If insulin is the causal mechanism, however, a diet     high in processed carbohydrate could predispose to overeating and weight gain, as this diet     requires higher insulin doses.      To disentangle these factors, we will study brain activation and relevant blood markers in 15     men with diabetes. In 4 sessions, we will examine meals with differential carbohydrate     properties while giving insulin infusions.   "
39183|NCT02772770|"     Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort     study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of     non-operative treatment, as well as four operative treatments including (1) transphyseal ACL     reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal     ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction     using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature     patients.   "
39184|NCT02772757|"     The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes     between the traditional, fitting approach where the patient is present during the visit and a     coupler-based fitting approach where the patient is not present and mailed their hearing     aids. If the coupler-based fitting protocol tested in this study as effective as the     traditional fitting protocol, then patients receiving replacement hearing aids may circumvent     a face-to-face visit.   "
39185|NCT02772744|"     This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From     June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus     genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of     Egyptian ministry of health and population. The primary outcomes are safety of the treatment     and the sustained virologic response 12 weeks after discontinuation of therapy. For the     secondary outcomes, investigators will measure the change in health related quality of life     and investigate the genetic sequence of viral RNA of resistant patients.   "
39186|NCT02772731|"     Breast cancer is the most common malignancy affecting women in the US. Surgical management is     the mainstay of therapy, and in general consists of resection of the primary tumor with     either a partial mastectomy (aka lumpectomy) or a total mastectomy.      The investigators hypothesize that routine shave margins during partial mastectomy will     significantly reduce positive margin rate. A positive margin means that cancerous cells were     detected at the edge of the excised area. This generally mandates a return to the operating     room for re-excision.   "
39187|NCT02772718|"     The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in     patients with hypoglycemia after gastric bypass surgery.   "
39188|NCT02772705|"     The purpose of this study is to find out the capacity of standardized uptake value (SUV)     using single-photo emission computed tomography and computed tomography (SPECT/CT) in     diagnosing Grave's Disease (hyperthyroidism).   "
39189|NCT02772692|"     Whether functional consumption is influenced by defecation postures is unclear. The     investigators investigated effects of defecation postures on functional consumption.   "
39190|NCT02772679|"     The purpose of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in     patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2.   "
39191|NCT02772666|"     This study is to evaluate the ability of a newly designed device, Optic Nerve Glass (O-Glass)     to detect relative afferent pupillary defect (RAPD). In this prospective study, 44 patients     (diagnosed RAPD- positive) enrolled the study. They were examined for an RAPD by O-Glass and     also manual swinging flashlight method (SFM) . This newly designed instrument captures and     records eye pictures. The images will be processed and analyzed using computerized software     to calculate pupillary measurements.   "
39205|NCT02772484|"     The HS-1000 device, an investigational intracranial monitoring device, has the potential to     safely and quickly diagnose and assess stroke (and potentially other neurologic conditions)     with minimal discomfort to patients. HS-1000 has the capability to establish cerebral     hemodynamic measurements in suspected stroke within minutes, assist with appropriate     management of stroke, and also provide an objective diagnostic tool for clinicians to monitor     recovery.   "
39206|NCT02772471|"     Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal     pressure transducer or external ventricular drain (EVD), provides an ICP waveform that     encapsulates valuable diagnostic and monitoring clinical information.      HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP     waveform safely and accurately with minimal discomfort to patients, compared to standard     invasive ICP monitoring procedures used at the participating institutions.   "
39449|NCT02769273|"     Prospective, international, multi-center, single arm, observational study to continue to     assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial     femoral and/or popliteal arteries according to the Instructions for Use in a broad,     real-world, claudicant or ischemic rest pain patients population per the institution's     standard practice.   "
39221|NCT02772263|"     Older adults living in subsidized housing report poorer health. Their low income and age make     it harder for them to use community services. Many older adults have heart disease and     diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the     costs of treating heart disease and diabetes through emergency and hospitalization, improved     screening and health education is needed. The Community Health Assessment Program through     Emergency Medical Services (CHAP-EMS) program will take place in communal areas within     housing buildings of older adults and deliver a heart disease, diabetes, and falls risk     check-up with health education. This is expected to improve the health of older adults     leading to fewer emergency calls and hospital visits.      Paramedics on modified duties (e.g. injured) will conduct weekly, one-on-one drop-in sessions     for seniors in a common area of one subsidized apartment building in Hamilton, Ontario.   "
39192|NCT02772653|"     Severe trauma patients have an elevated risk of multiple organ failure and death. In order to     increase survival possibilities the initial treatment must be focused into resuscitation from     shock. Traditionally the most common resuscitation markers used are vital signs and urine     output. Unfortunately, many patients might present normal vital signs, but still undergo a     compensated shock with persistent acidosis, hence being able to develop multiple organ     failure and death. Consequently, it is important to define better resuscitation markers for     these patients.      This investigation project consists in an observational prospective study, performed by a     multidisciplinary team, in which different resuscitation markers are evaluated in severe     trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival)     evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical     (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS);     microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry).     There will be a registry of total volume administration; blood cell transfusions and     vasoactive drug requirements. Each marker will be evaluated in relation to mortality;     multiple organ failure; massive transfusion protocol activation; blood cell transfusion     requirement; surgical control of bleeding requirement and emergent arteriographic     embolization. The objective of this study is to demonstrate which of these markers is better     to predict hemodynamic evolution of severe trauma patients and might become a guide for     resuscitation in the future.   "
39193|NCT02772640|"     The aim of the study is to demonstrate, whether the time of day of administration of the     study drug (containing rosuvastatin and ezetimibe) has an impact on the effectiveness of     lipid-lowering therapy.   "
39194|NCT02772627|"     The purpose of this study is to investigate the tolerability and safety of three multiple     dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy     volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition     profiles of nebicapone in healthy volunteers.   "
39195|NCT02772614|"     The purpose of this study is:      To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and     faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of     total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in     plasma   "
39196|NCT02772601|"     To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a     means of predicting drug-drug interactions.   "
39197|NCT02772588|"     The purpose of this study is to determine whether anti-testosterone medications, when     administered before, during, and after high-dose, precision radiation, will be effective in     preventing the prostate cancer from returning.   "
39198|NCT02772575|"     The purpose of this study is to see if certain genes the tumor can help predict how the tumor     will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and     functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the     hereditary material in humans. Identifying a gene that can predict how liver tumors will     respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.   "
39199|NCT02772562|"     The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer     from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.   "
39200|NCT02772549|"     Patients with newly diagnosed IPF are investigated for the diagnostic delay before a     diagnosis of IPF is made.   "
39201|NCT02772536|"     Background      An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that     viewing particular tints of light appeared to result in some improvement of their tinnitus.      This ameliorative effect appeared to be primarily acute and only reported to occur whilst     viewing the tint. Individual patients would choose differing tints with some identifying more     than one tint that affected their tinnitus.      Aim of the Study      In this current basic science study, the aim is to provide preliminary data to return     estimates of the efficacy of using tinted light to ameliorate tinnitus.      After identification of responders during screening, responders are invited to attend three     further trial sessions, where their tinnitus is assessed in response to three luminance     conditions: Low Ambient Light; Tint of Light affecting Tinnitus; White Light.      The response to low ambient light serves as a control to compare the effect of tinted light     against and the response to white light serves as an 'active' stimulus comparator.      These results will then establish whether tinted light provides patients with a useful     improvement in their tinnitus compared with measures of their baseline tinnitus obtained in     the dark and against a standardised white light stimulus.      They will also inform further development of the technique as a potential treatment for     tinnitus in responsive patients.      Over the three sessions, the averaged responses given by the patient under each stimulus     condition will be analysed to provide a measure of efficacy.   "
39202|NCT02772523|"     Recent epidemiologic studies are identifying a number of modifiable risk and protective     factors that may influence in the incidence of Alzheimer's disease (AD). Therefore, the     combination of an early detection of individuals at risk together with interventional studies     targeted to the control of modifiable risk factors makes primary prevention programmes to     become a new and real therapeutic strategy.      In this scenario, the investigators have designed the ALFAlife study, a programme of control     and intervention on the modifiable AD risk factors. Throughout this study, participants will     be given a number of healthy lifestyle guidelines that are personalised depending on their     specific risk profile. These guidelines refer to smoking and dietary habits and physical,     cognitive and social activity. The investigators hypothesis is that the follow-up of these     guidelines will favor a change of participants' lifestyle habits towards healthier ones. In     addition, the investigators hypothesise that changes in these lifestyle habits will have an     effect on objective physiological measures (such as blood pressure and cholesterol levels).   "
39203|NCT02772510|"     The purpose of the present study was to investigate the effects of game-based virtual reality     rehabilitation combined with functional electrical stimulation on distal upper extremity     function, and compare the findings to those of functional electrical stimulation in stroke     survivors.   "
39204|NCT02772497|"     The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with     intravitreal ziv-aflibercept.   "
39207|NCT02772458|"     Crohn's disease (CD) is becoming more common, specifically in the western world. One of the     main features of this disease is weight loss and malnutrition. Although clinically common,     these problems are not well understood. Loss of appetite and symptoms such as tummy aches and     bloating are common causes for weight loss in this group of patients. This problem has a     strong negative effect on the patients' quality of life and significantly increases the cost     of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the     brain to control food intake. Recent evidence has showed that these cells increase in number     in active CD and secrete more hormones that negatively affect appetite. The increased levels     of these hormones should have an overall negative effect on the brain and thus decrease food     intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are     hypotheses that require further proof. Current technological advances in magnetic resonance     imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain     that control food intake. The involvement of the brain in control of food intake is still not     fully understood. This work will be the first step in the right direction to start targeting     the problems of appetite, weight loss and a poor quality of life.   "
39208|NCT02772445|"     The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in     caregiver and care-recipient outcomes   "
39209|NCT02772432|"     This study has three aims:      Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and     parents with children with special needs, this study aims to identify the psychosocial needs     of parents of children with learning disabilities, specifically a) the types of concerns that     parents find most difficult and stressful b) areas of concern that lack support and     resources, and c) areas of need for education and skill training. This study also aims to     gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP).      Phase II: Informed by Phase I findings, this study aims to develop and determine the     feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)     program for parents of children with Specific Learning Disabilities (SPLD).      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,     establishing efficacy of a virtual resiliency program.   "
39210|NCT02772419|"     The objective of this study is to evaluate the efficacy and safety of SC administrations of     Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a     multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and     immunogenicity will be assessed secondarily.   "
39211|NCT02772406|"     The purpose of the study is to determine whether a new colonoscopic viewing technique called     Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative     colitis patients than conventional colonoscopy using white light alone.   "
39212|NCT02772380|"     The main purpose of this clinical study is to collect electrograms from an investigational     lead placed in an extravascular space, for development of a future Implantable Cardioverter     Defibrillator (ICD) system.   "
39213|NCT02772367|"     The purpose of this study is to investigate whether cells from a biopsy taken from the     patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart     muscle cells) when grown in a special culture medium outside of the body. The structure and     function of these cells will then be studied to determine why some patients with breast     cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and     anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.   "
39214|NCT02772354|"     To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in     the pediatric population as first-line therapy compared with antiarrhythmic drugs.   "
39215|NCT02772341|"     Background: Asthma is a chronic inflammatory disorder requiring intermittent or continuous     anti-inflammatory therapy. Patients often turn to alternative treatments as complements or     replacements to conventional treatments.      Aim: To evaluate the effect of salt room chambers (halotherapy) on bronchial hyper-     responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children     with asthma.      Patients: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving     anti-inflammatory therapy.      Methods: Randomized, double-blind, placebo-controlled study assessing the effect of salt room     therapy on BHR, FeNO, spirometry and pediatric asthma quality of life questionnaire (PAQLQ).     The treatment period lasted 7 weeks, 14 sessions with (treatment group) or without salt     halogenerator.   "
39216|NCT02772328|"     The purpose of this study is to test an intervention designed to train persons who inject     drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1)     promote new HCV treatment and care 2) risk reduction and 3) recruit their social network     members for HIV and HCV testing and linkage to care.   "
39217|NCT02772315|"     The purpose of this study is to assess the validity and usefulness of omics signatures for     improved identification and risk stratification of patients with endocrine hypertension and     stratification of patients with primary hypertension.   "
39218|NCT02772302|"     The primary aims of this study are:        1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based          system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or          locked-in syndrome (LIS);        2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with          bedside behavioral assessments of consciousness;        3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with          functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;        4. To determine if mindBEAGLE can serve as an assistive communication device for people          with LIS.   "
39219|NCT02772289|"     The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells     treatment on the appearance of a caesarean scar as compared to a similar untreated scar.   "
39450|NCT02769260|"     The purpose of this study is to determine in situ the bacterial viability, thickness and     bacterial diversity of a biofilm formed on different substrates in comparison to a naturally     tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral     hygiene measures may influence the development of the PL-Biofilm.   "
39222|NCT02772250|"     The study compares the efficacy of bowel preparation between the face-to-face     re-education(FFRE group) and normal education (no-FFRE group) in patients.   "
39225|NCT02772211|"     This is a two-stage experiment; the first stage is an open label trial in which participants     receive six intravenous (IV) treatments of ketamine. The second stage includes participants     that responded to ketamine (i.e. reduction of 25% in their symptoms of depression, as     measured by the Montgomery Asberg Depression Scale MADRS). The second stage is a     double-blind, controlled clinical trial of D-cycloserine (DCS) vs. placebo, as maintenance     treatment in patients who responded to ketamine treatment. The aim of the study is to     determine whether 8 weeks of DCS maintenance therapy will prevent relapse of depressive     symptoms following ketamine infusions   "
39226|NCT02772198|"     This phase 1 / 2 study will evaluate the response of B-cell malignancies expressing CD19 to     autologous T cells transduced with a second generation anti-CD19 chimeric antigen receptor in     children and young adults.   "
39227|NCT02772185|"     This study is a double blind, sham-controlled clinical trial aiming to compare the long-term     effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in     a phase II/III clinical study over a 1-year period. The study involves transcranial direct     current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and     neurological testing. These assessments will occur at baseline, then again at two month (end     point). Those who achieve clinical improvement with neurostimulation and cognitive therapy     will be invited to receive treatment for 12 months as part of a follow-up study.   "
39228|NCT02772172|"     The main purpose of the present study is to evaluate the dental implant placement using two     different CBCT-derived templates and to study the related factors that affect accuracy so as     to support the further clinical application of the technique. Thirty patients with partial     edentulous denture are recruited. They are randomized to two groups. A radiographic guide is     prepared before CT/CBCT scan. The CT/CBCT scan DICOM ﬁles are loaded in a planning program     and converted into 3D computer images. A surgical template is fabricated through this virtual     planning. After 6 weeks, if the implants are judged stable, the patient has the option of     replacing the ﬁxed prosthesis. Patients are recalled for oral hygiene maintenance and     prosthetic controls every 6 months for the entire duration of the study.   "
39229|NCT02772159|"     The purpose of this study is to evaluate the absorption, distribution, metabolism and     excretion of an investigational medication used to treat chronic obstructive pulmonary     disease (COPD). The study drug will be tested in 6 healthy normal males. Dosing will include     a single dose of study drug administered via an IV Infusion and an Oral Dose. There will be a     28 day washout period between each of the 2 dosing routes.   "
39230|NCT02772146|"     A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient     will be studied during a single treatment session of ten hours. The device will be connected     to an existing, standard PD catheter that the patient will be using routinely prior to the     study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study).     The patient will be hospitalized for observation during the test day and during the night     following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood     glucose concentrations as well the patient's acceptability and tolerance of the wearable     device will be evaluated.   "
39231|NCT02772133|"     Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation     myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on     circulating prolylcarboxypeptidase (PRCP) level and activity.   "
39232|NCT02772120|"     The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50     years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of     age) as part of their IVF treatment are not different with respect to the administration of     progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).   "
39233|NCT02772107|"     Temozolomide may delay progression in sequence with chemotherapy. This open-label,     randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide     following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly     diagnosed estensive-stage SCLC.   "
39244|NCT02771964|"     This study will compare two commonly-used methods for assessing patient-reported quality of     life. The first is to assess quality of life before surgery and again after surgery using the     same validated scale (ie Veterans Rand 12). The second is simply to ask patients whether or     not they think their post-operative quality of life is better, worse, or the same. The     investigators hypothesize that the second method may be inaccurate due to cognitive bias.   "
39245|NCT02771951|"     This randomized controlled trial tests the efficacy of a culturally and linguistically     appropriate, evidence-based intervention to slow weight gain or promote weight loss among     overweight 6-9 year old Mexican-American children.   "
39451|NCT02769247|"     To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and     pain of patients undergoing intrauterine device insertion.   "
39234|NCT02772094|"     Purposes:      The purpose of this phase-II clinical trial is to determine whether or not ADCTA-G, a     biologic vaccine preparation of patient's own dendritic cell (DC) for glioblastoma     multiforme (GBM) treatment, is safe and effective in extending the GBM patient's life. The     current conventional multi-modal regimen that may include surgery for tumor resection or     biopsy, temozolomide (TMZ) combined chemo-radiotherapy (CCRT) and TMZ adjuvant chemotherapy     almost always leaves residual GBM cells to cause fatal recurrence, leading to medium survival     period of 8 -15 months and over-all survival rates of about 30% in 2 years and <3% in 5 years     after diagnosis/surgery. Thus, in neurosurgical oncology practice, GBM patients in the first     2-year period during and after receiving multi-modal therapy are watched closely for possible     GBM tumor recurrence and mortal disease relapse and immediately given palliative treatments     and health care, until death. In this phase-II trial, GBM patient participants who receive     ADCTA-G vaccine adjuvant immunotherapy (added to the conventional multi-modal regimen) will     be similarly watched closely by treatments and health care visits at least biweekly from the     date of surgery/diagnosis to 24 months, and if alive followed by weekly phone calls and     scheduled health care visits at least once every 3 months, up to 72 months after surgery. In     the trial protocol, ADCT-G in 10 doses is administered after surgery, over a period of 6 or 8     months, as an adjuvant immunotherapy of the conventional multimodal regimen. Individual     ADCTA-G vaccine lot of every participant GBM patient is manufactured from patient's own     monocyte-derived dendritic cells and the patient's own tumor cell antigens, both of which are     prepared by a distinct method of procedures performed within air particle-free barrier good     laboratory practice (GLP) facility. Previous phase I/II clinical trial of ADCTA-G vaccine     immunotherapy administered as an adjuvant to the conventional multimodal regimen, has     obtained promising safety and efficacy results for GBM patients in a clinical center. This     phase-II clinical trial in China Medical University Hospital-Taichung will employ essentially     the same clinical protocols and the same distinct vaccine manufacturing method of standard     operational procedures (SOP), that is, the conventional multimodal regimen plus adjuvant     immunotherapy using personal ADCTA-G vaccine lot for every GBM patient participants.   "
39773|NCT02765022|"     An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure     with clips of mucosal defects after endoscopic mucosal resection (EMR) of large     non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.   "
39236|NCT02772068|"     Heart failure with preserved ejection fraction or HFpEF, represents nearly 50% of all heart     failure cases and is particularly common in the elderly. The disease has no current treatment     options. Symptoms typically occur during exertion or exercise and is likely the result of     increased cardiac and pulmonary congestion as a result of impaired diastolic function.     Istaroxime is a novel activator of SERCA2a, an important regulator of calcium uptake within     the myocyte. We will test the hypothesis that Istaroxime will improve diastolic function     during exercise in HFpEF patients which in turn will reduce cardiac and pulmonary congestion.   "
39237|NCT02772055|"     This is a multicentre, randomised, single blinded, parallel-group design clinical trial to     assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.   "
39238|NCT02772042|"     Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and     manipulation of upper cervical spine are the most popular treatment in this patients. The     International Federation of Orthopaedic Manipulative Physical Therapists suggest different     recommendations for the safety application of manual therapy techniques in the upper cervical     spine, traction manipulation techniques complies with this conditions. However, there isn´t     investigation about the effect of traction manipulation in patients with cervicogenic     dizziness. The aim of this study is to investigate the effects of traction manipulation in     dizziness intensity, range of motion of cervical spine and quality of life on patients with     cervicogenic dizziness.   "
39239|NCT02772029|"     Hepatocellular carcinoma (HCC) is one of the lethal human cancers worldwide and its incidence     matches mortality, reflecting the poor prognosis of this disease. The surgical resection rate     of HCC is low, and the prognosis is poor. Although transarterial chemoembolization (TACE) is     the main treatment for HCC patients who are not candidates for surgical resection, it is not     considered a curative procedure. For HCC, poor TACE efficacy or TACE failure may be related     to tumor angiogenesis of the residual disease. Among the many regulatory factors in tumor     angiogenesis, hypoxia-inducible factor-1α (HIF-1α) and vascular endothelial growth factor     (VEGF) play vital roles in this process.      Sorafenib is the first systemic treatment drug, which has been approved by the FDA for     advanced HCC. In order to find an new VEGFR-inhibitor with better effect and lower toxicity,     Jiangsu Hengrui Medicine Co., Ltd. developed Apatinib, a high-performance VEGFR-2 tyrosine     kinase inhibitor. Apatinib plays anti angiogenic effect in the treatment of malignant tumor     mainly through inhibition of VEGFR-2, in vivo and in vitro experiments showed good tumor     growth inhibitory activity on glioma, this study aims to further verify the efficacy and     safety of Apatinib for first-line treatment failure hepatocellular carcinoma patients, the     primary endpoint is time to progression(TTP).   "
39240|NCT02772016|"     Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild     anemia were randomly assigned to treatment group and control group. Patients in the treatment     group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control     group were observed and followed up in the same period without any treatments. Levels of     hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components     [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured     before and after treatments.   "
39241|NCT02772003|"     The purpose of this study is to determine whether INO-8000 alone or in combination with     INO-9012 (IL-12) is safe and induces an HCV-specific immune response.   "
39242|NCT02771990|"     The goal of this study is to investigate the role of central neural pathways in mediating     chronic pain. The aim of the study is to test the effect of stimulating brain regions that     are part of a network underlying central pain processing using a non-invasive brain     stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have     used tDCS to target both sensory related cortical areas and those important for higher-order     representations of pain. This study will target brain regions important for the behavioral     response to the chronic sensation of pain. The hypothesis is that stimulation of these brain     regions can modulate not only the affective component of pain, but ultimately also improve     functioning and quality of life. This hypothesis will be tested by treating study     participants eighteen and older with chronic low back pain (CLBP) of greater than six months     using tDCS. To be part of this study, participants must meet all the inclusion and exclusion     criteria.   "
39243|NCT02771977|"     In this trial, patients with acute kidney injury who have recently received a drug that may     affect kidney function will be randomized to having an alert placed in the electronic health     record or usual care.   "
39475|NCT02768935|"     The prevalence of type 2 diabetes is growing steadily. Patients with diabetes, cardiovascular     complications (such as myocardial infarction (MI)) are more frequent and severe than in     non-diabetic subjects. The anti-diabetic therapies available have little or no effect on the     incidence of cardiovascular events. It is therefore urgent in diabetics develop new     therapeutic strategies to reduce the occurrence of MI or limit the consequences.      In the two weeks following MI, monocytes / macrophages are the most represented in the     ischemic heart tissue cells. The infiltration by monocytes / macrophages after infarction MI     is a two-phase process. In the first phase, monocytes / macrophages M1 promote digestion     injured areas, and monocytes / macrophages M2 intervene to promote angiogenesis, collagen     deposition and contribute to tissue repair. The optimal repair after myocardial infarction     depends on effective recruitment of monocytes and macrophages M1 transition needed to digest     the damaged tissue and M2 macrophages necessary for tissue repair. The balance between these     two phenotypes M1 and M2 is controlled by different modulators, such as transcription     factors, cellular miRNA and miRNA extracellular contained in the microvesicles (MVs).     Interestingly, plasma MVs circulating essentially derived monocytes and platelets contain     miRNA and are impaired by inflammation or during various pathological situations (such as     IDM). Furthermore, metabolic disorders such as hypercholesterolemia (often associated with     diabetes) affect the transition from M1 to M2 response and response delay cardiac repair. To     date, the mechanisms that control the M1 / M2 transition at heart level are not elucidated.     Moreover, the impact of diabetes, which leads to chronic low-grade inflammation, is not     explored. Targeting the immune response by promoting the transition M1 / M2 after MI could be     an innovative therapeutic approach. However, better characterization of the response of M1     and M2 macrophages after MI and the mechanisms by which they contribute to tissue remodeling     and the effect of diabetes are needed. The goal is to study how the phenotypes / macrophage     functions after MI are changed by diabetes and to determine the potential role of miRNAs     contained in secreted MVs in the transition M1 / M2 after MI.      Monocytes / macrophages from subjects with normal blood sugar or diabetes who underwent an     IDM (10 per group) will be characterized phenotypically. Their ability to produce MVs will be     analyzed. These MVs will be tested functionally for their ability to orient the polarization     of healthy recipients monocytes. The content of these MVs in terms of miRNAs will be analyzed     in detail. By bioinformatics analysis, some miRNAs of interest (based on their abundance and     target genes) will be selected. These miRNAs are over-expressed in macrophages and MVs     produced by these cells will be analyzed for their ability to modulate differentiation of     monocytes recipients. Finally, the circulating levels of these miRNAs of interest will be     measured after 1 year of IDM and will be correlated to the clinical phenotype of patients     (recurrence, arrhythmias, heart failure). Ultimately, the goal is to identify VMs that can     promote the differentiation of monocytes to an alternative phenotype and identify miRNAs     responsible for this effect. This could help in the future, in a subject with impaired     ability of monocytes to differentiate alternatively, can change by introducing the miRNA of     interest to re-inject or inject MVs macrophage containing the miRNA of interest and thus     correct the defect of differentiation.   "
39246|NCT02771938|"     Many women with breast cancer now live for decades after their breast cancer treatment. In     view of this, modern breast reconstruction surgery after mastectomy for breast cancer aims to     reproduce as natural a breast shape as possible. Keeping a natural breast appearance has been     shown to be very important to a woman's emotional and psychological recovery.      Breast cancer treatment often includes a combination of surgery, chemotherapy, radiotherapy,     anticancer tablets such as Tamoxifen, and newer targeted drugs such as Herceptin.     Radiotherapy is usually given after surgery. However, radiotherapy after mastectomy and     breast reconstruction can damage the 'new' breast giving a less good breast shape and     appearance in the longer term. Also, if recovery is slow following surgery, the radiotherapy     is delayed which may reduce its effectiveness. Changing the order of treatments has been     shown to be safe and effective for chemotherapy, Herceptin and anticancer tablets but we have     very little information on giving radiotherapy before breast cancer surgery.      The investigators want to find out if giving radiotherapy before mastectomy and     reconstruction alters surgical complication rates and they want to evaluate the appearance of     the reconstructed breast when radiotherapy is given before surgery.   "
39271|NCT02771613|"     After implementing a French version of a trigger tool validated for computerized detection of     adverse events in patient's medical record, the study will be performed in three parallel     randomized arms of three identical departments (each steaming from 6 types of medical,     surgical or obstetrical departments with a total of 18 departments involved). This three arms     will be: no intervention, education of department's staff by multi professional in situ     simulation (adapted to the discovered adverse events), or simple but large diffusion of     results and decisions of Morbidity Mortality Reviews.      The interventions will be performed during a two-years period.   "
39247|NCT02771925|"     Alcohol use disorders are present across medical specialties, with alcohol-related deaths     particularly prevalent in the categories of injury, liver cirrhosis, cancer, cardiovascular     disease, disorders of the peripheral nerves and of the central nervous system. Alcohol     dependence, also referred to as alcohol use disorder, is a chronic, relapsing disorder marked     by compulsive alcohol use, an inability to stop drinking despite harmful consequences, and     the emergence of a withdrawal syndrome upon cessation of use. Early abstinence is associated     with activation of brain stress systems in the extended amygdala. Clinically, protracted     abstinence involves symptoms of craving, mood and sleep disturbance, all of which have been     identified as risk factors for relapse. Nonetheless, implementation of alcohol-specific     medications remains limited across most medical specialties. Medications for treating alcohol     dependence primarily have been adjunctive interventions, and only three     medications—disulfiram, naltrexone, and acamprosate—are approved for this indication by the     United States Food and Drug Administration. Baclofen, an inhibitor of synaptic transmission     through spinal reflex arcs via hyper polarization of primary afferent fiber terminals, was     originally approved by the Food and Drug Administration in 1977 for use in spasticity     associated with neurologic conditions, such as multiple sclerosis and spinal cord lesions.     However, due to its pharmacologic properties it has also been investigated for the treatment     of alcohol dependence. But in the clinical practice of study physicians, it was observed that     most of the patients who were prescribed baclofen for alcohol dependence hit back to alcohol     very soon despite being on the drug. Therefore there is a need to search for an alternative     drug which could be beneficial for this population of patients. Gabapentin is Food and Drug     Administration-approved for the management of epileptic seizures and neuropathic pain. It is     believed to act by blocking a specific alpha-2d subunit of the voltage-gated calcium channel     at selective presynaptic sites and, as a result, to indirectly modulate Gamma Butyric Acid     neurotransmission. Pre-clinical findings indicate that gabapentin normalizes the     stress-induced Gamma Butyric Acid activation in the amygdala that is associated with alcohol     dependence, and provide an excellent pre-clinical rationale for evaluating gabapentin as a     treatment for alcohol dependence. Earlier studies of gabapentin in alcohol dependent     subjects, attempting to abstain following withdrawal support the safety and potential     efficacy of gabapentin in alcohol dependent patients, but definitive conclusions were limited     by either small sample size, methodological, or dosing issues.   "
39248|NCT02771912|"     Controversies exist about the use of propofol in sedation of patients for cataract surgery.     This prospective randomised double-blind study evaluates the efficacy of patient-controlled     sedation compared with placebo using the same device.   "
39249|NCT02771899|"     Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to correct     scoliosis will be included in this study, for which participation will last 6 months. Each     age group of participants will be randomized to two cohorts: one cohort will receive standard     of care, while the other will also have their standard radiographic images used in the     construction of a three-dimensional visualization of the spine. Questionnaires administered     before and after surgery, in addition to health information collected throughout the course     of the study, will indicate whether the three-dimensional model has an effect on the     planning, performance, and outcomes of surgery. Participants in this study will not be asked     to do anything outside the standard of care. The only manipulated variable in this study is     the construction of the three dimensional model, which is made from information collected     during the standard of care, and requires no further action on the participant's behalf. The     results of this study may show that three-dimensional visualizations can be of value to     spinal surgeons, and positively affect patient outcomes.   "
39250|NCT02771886|"     The purpose of this study is to evaluate the effectiveness of a brief Surf the Urge     intervention to reduce adolescent and young adult (i.e., 14 to 24 years old) urge-related     behaviors. These behaviors will include, but not be limited to, substance use, deliberate     self-harm, aggressive behavior, pulling out hair, and loosing control when eating.The     intervention will utilize mindfulness skills (i.e., awareness, acceptance, nonjudgment) to     assist in reducing these risky behaviors.   "
39251|NCT02771873|"     The overall goal of the study is to test the effectiveness and sustainability of an     integrated care model for managing cardiovascular risk in individuals with family history of     premature coronary heart disease (CHD).      This care model involves:        1. screening for cardiovascular risk factors,        2. providing lifestyle interventions for prevention and management of cardiovascular risk          factors,        3. providing a framework for linkage to appropriate primary health care facility and        4. active follow-up of intervention adherence.      Initially, a formative qualitative research component will gather information on     understanding of diseases, barriers to care, specific components of the intervention package     (for example, context specific ways to enhance physical activity and to reduce prolonged     sitting time, ways to improve diet etc.) and feedback on the intervention strategies     (lifestyle education, care and linkage coordination). Then a randomized controlled trial     involving ~700 families and 1400 participants will be used to determine whether an integrated     care model is effective in reducing or halting the progression of CHD risk factors and risk     factor clustering in families. The sustainability and scalability of this intervention will     be assessed through economic and qualitative lenses to estimate value and acceptability.     Scalability will be informed by cost-effectiveness and acceptability of the integrated     cardiovascular risk reduction approach.   "
39252|NCT02771860|"     This is a randomized, double blind placebo controlled one-site proof-of-concept study in     subjects with erosive osteoarthritis (OA) of interphalangeal (IP) finger joints.      A total of 100 subjects will be enrolled into the study: 48 weeks placebo controlled     double-blind phase with denosumab 60mg every 12 weeks, followed by a 48-week open-label phase     in which all subjects will receive denosumab.   "
39253|NCT02771847|"     The pain associated with disorders of the masticatory system (DAM) include pain in the     masticatory muscles, temporomandibular joints, or deux.1-5 In terms of frequency, the DAM is     the second musculoskeletal disorder most common behind chronic pain in the dos.      Pain associated with DAM not interested adults; they were also observed in adolescents (2-6%)     7 with significant changes in their quality of life.8 The annual incidence of pain associated     with DAM is 2.6% among adolescents and 3.9% for adults. 9 half to two-thirds of patients     affected by DAM resorted to professional care, and one-third continued to be subjected to     moderate pain and incapacity to severe, regardless of treatment given.      Co-morbidities were identified in adults 12-14, children and adolescents with pain related to     DAM, the United States and Suède. The most common painful co-morbidities among children and     adolescents were headaches, neck, back, limbs or abdomen.      The reasons for the co-existence of DAM with other painful conditions are not well     understood. Nevertheless, it has been demonstrated in adults that they contributed to     apparition and persistence DAM beyond healing time conventionally predicted; they increased     deterioration state health and could complicate significantly the diagnosis and efficacy of     treatment.      Co-morbidity is defined as the simultaneous existence and the occur two or more diseases,     medically diagnosed in the same person.      The prevalence of several chronic painful conditions appears to be greater among people of     low socioeconomic status compared with those of higher and higher socioeconomic status among     women than hommes.      head pain is commonly reported in the general population (46%) The headache prevalence ranges     from 9% to 97% among adults and 30% to 94% among Adolescents with DAM.      Women have a higher probability have pain related to DAM (odds ratio (OR) = 2.2, 95%     confidence interval (CI): 2.1-2.4) or headache (OR = 2.5, 95% CI: 2.4-2.5) than men.     Cross-sectional studies and case-control demonstrated that subjects with DAM-related pain     were 1.5 to 8.8 times more likely to have headaches compared to those without pain associated     with DAM.      The relationship between headaches and DAM n`est unclear. Both conditions seem to share     similar pathophysiological mechanisms that would promote the development of both diseases in     a individual. Patients affected by headaches are more likely to develop a DAM? A cohort study     showed that adolescents affected by headaches, the chance of developing pain related to DAM     was 2.7 times (95% CI: 1.6-4.4) than adolescents without headaches. Conversely, the     probability of having headache increases with the number of symptoms according to a     relationship of DAM.      Following the results of these studies cited before, it is now necessary to confirm the     relationship between headaches and DAM among adolescents.      Neck pain and back are symptoms commonly reported in adults with DAM (35% to 44%). 23 The     adults affected by DAM have smaller mobility angles in the cervical and more sensitive points     to trapezoids when compared to those without DAM.      Cross-sectional studies and case-control have demonstrated that adult patients with     DAM-related pain had 2.6 to 5 times more likely have back pain than individuals without pain     related to DAM. Chances pain joint (OR = 4.0, 95% CI: 3.7-4.3) are larger among adults     affected by DAM related pain compared to those indemnes. adults affected by DAM-related pain     were also more likely to experience neck pain (OR = 4.0 to 7.9).      Adult women affected by DAM-related pain are more likely to have pain in the neck (OR = 1.5;     95% CI: 1.4-1.8) and back (OR = 1.2; 95% CI: 1.2-1.3) compared to hommes a prospective cohort     study demonstrated that there was a greater likelihood of pain related to DAM among     adolescents affected by back pain compared to those not affected (OR = 3.0, 95% CI: 2.2-6.8)     Our study aims to seek more evidence on the supposed relationship between pain related to DAM     and sore neck or back in the adolescent population.      The irritable bowel syndrome (CIS; 9% to 16%), interstitial cystitis (17%), and stomach pain     (34%) are rated among adults affected by DAM. Adults affected by DAM were 2.7 times (95% CI:     1.4-5.1) more likely to have irritable bowel syndrome than subjects of the same age not     affected. teenagers affected by DAM were 1.5 times (95% CI: 1.0- 2.1) over have luck stomach     upset that the subjects of the same age unaffected.   "
39254|NCT02771834|"     The incidence of osteoporosis has been increasing, as have fractures resulting from falls.   "
39255|NCT02771821|"     Randomized clinical trial with the objective of evaluating the effectiveness of operative     groups to promote healthy habits in elderlies diabetics. The study was conducted in the     Family Health Units of Microregion 4.2 Sanitary District IV of Recife, Pernambuco, Northeast     Brazil. Participated in 202 elderlies diabetic randomly assigned to two groups: intervention     and control, with similar characteristics in relation to age. Data collection occurred from     August 2014 to August 2015 and elderlies were followed for 6 months (T0 to T6). Control group     participated in the routine individual consultation with the staff of the Family Health Unit     on a quarterly basis. Intervention group participated the routine individual consultation     with the staff of the Family Health Unit on a quarterly basi and six operative groups of     health education, with monthly frequency and duration of two hours, using the methodology of     problematization (FREIRE, 2011), with themes identified from the needs of the participants.   "
39348|NCT02770586|"     The hypothesis of this study is that positron emission mammography will provide comparable     sensitivity to contrast-enhanced breast MRI in women with a high suspicion of breast cancer.      The aim of this study is to determine the sensitivity of Positron Emission Mammography (PEM)     relative to that of Contrast-enhanced breast MRI (CE-MRI) in women with a high suspicion of     breast cancer   "
39256|NCT02771808|"     Specific aim 1a will test the hypothesis that diabetic patients with 2-2 haptoglobin genotype     have higher indices of postoperative myocardial injury (creatine kinase MB isoenzyme ,     Troponin I ) and renal injury (as indicated by elevated creatinine, cytostatin C and     glomerular filtration rate). Of note, significantly elevated levels (>5 times the upper     normal limit) of creatine kinase MB isoenzyme and troponins postoperatively have been     associated with postoperative myocardial ischemia/infarction and are a predictor of     short-term and long-term mortality after cardiac surgery.      Specific aim 1b will evaluate preoperative and postoperative indices of oxidative stress     (such as isoprostane f2 alpha and malondialdehyde) and will evaluate whether patients with     type 2-2 haptoglobin express increased oxidative stress. The investigators will also try to     correlate whether patients with increased oxidative stress are those with elevated indices of     myocardial and/or renal injury Specific aim 1c will try to evaluate whether patients with     type 2-2 haptoglobin also have increased levels of inflammatory indices (C-reactive     protein,[interleukin] IL-1, IL-2, IL-6, TNF[tumor necrosis factor]) and try to correlate the     findings with postoperative myocardial and or renal injury.      The incidence of atrial fibrillation after coronary artery bypass graft ranges from 19% to     27%. The investigators will also look at any correlation of the type 2-2 haptoglobin and the     incidence of post-operative atrial fibrillation.   "
39257|NCT02771795|"     A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or     Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC   "
39258|NCT02771782|"     This study has three purposes:      To investigate whether the immune response to pertussis is increased when TDaP-IPV is given     together with BCG vaccine, compared to when it is given alone.      To investigate whether BCG vaccination modulates the immune response to non vaccine target     antigens (i.e., antigens/pathogens not used in the vaccine itself).      To investigate whether TDaP-IPV vaccination modulates the immune response to non vaccine     target antigens.   "
39259|NCT02771769|"     This is a multi-centre prospective study in which blood samples will be taken from 1500 male     patients aged between 21-80 scheduled for prostate biopsy. Analysis of cell-free cancer DNA     extracted from these samples will be undertaken to determine whether copy number instability     scores derived from the cfDNA correlates with PSA screening levels and prostate biopsy     results (i.e. Gleason score) in these patients.   "
39260|NCT02771756|"     The purpose of this study is to research more reasonable and safe methods of nutritional     support to improve the nutritional status of tumor patients, which guarantees the anti-tumor     treatment such as chemotherapy.   "
39261|NCT02771743|"     The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the     treatment intensity of tandem high dose chemotherapy according to the treatment response to     induction chemotherapy.   "
39262|NCT02771730|"     The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines     that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an     immune response. Researchers want to see how the immune system will respond to these vaccines     as well as if they are safe to give to people. Participants cannot get HIV from these     vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious.     Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate     contacts will be asked to participate as well.   "
39263|NCT02771717|"     The purpose of this study is to determine whether a low exhaled nitric oxide reading (<27ppb)     is a good predictor of a negative response to inhaled steroid treatment for patients with     symptoms suggestive of asthma.   "
39264|NCT02771704|"     Dental caries is an infectious disease mediated by a consortium of microbes in the oral     cavity. The disease is characterized by demineralization of the tooth, if untreated, it leads     to cavitation, discomfort, pain and eventual tooth loss. Frequently, complete caries removal     of dentine carious lesions leads to exposure of the pulp affecting its vitality. Therefore,     it is crucial that vitality of the teeth is preserved causing little damage to the pulp.     Different approaches have been used to reduce or eliminate microorganisms underneath the     restorations. Chlorhexidine has a strong antibacterial effect, particularly on planktonic     bacteria. Its effect on bacterial biofilms is compromised, however The objective of this     study is to examine the in vivo effect of diamine silver fluoride, potassium iodide and their     mixture on bacteria present in deep carious lesions. Dentine samples from 5 carious lesions     from each of 5 patients before and after treatment with test agents will be collected in     pre-reduced sterile Ringer's solution and processed for microbiological evaluation. The     samples after serial dilution and plating will be incubated in aerobic, anaerobic and CO2     atmosphere for 2-5 days. Colony forming units will be enumerated and the effect of     antibacterial agents in question on the bacterial viability in carious lesions will be     assessed.   "
39265|NCT02771691|"     This is a prospective parallel group design of group-based Mentalization-Based Therapy for     Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A     plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the     effectiveness of our recruitment strategies; compliance with protocol/procedures; trends     towards reduced self-harm.   "
39266|NCT02771678|"     The aim of this project is to estimate the quality of life for people with asthma and     specifically the loss in quality of life associated with an asthma-related crisis event     (accident and emergency (A&E) attendance or admission).   "
39269|NCT02771639|"     Introduction Periprosthetic joint infection (PJI) is a severe complication to hip     arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention     (DAIR) is recommended in early PJI in association with stable implants. Few studies have     evaluated the outcome of DAIR in this fragile population.The purpose of this study was to     analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with     a hip arthroplasty.      Methods A consecutive series of patients had been treated with either a total hip     arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were     retrospective analysed.   "
39270|NCT02771626|"     This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in     patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.   "
44268|NCT02706249|"     Hospitalized patients with histologically or cytologically confirmed diagnosis of solid tumor     malignancy or lymphoma and who are at high risk for a venous thromboembolisn will be     randomized to standard dose versus intermediate dose enoxaparin.   "
39272|NCT02771600|"     Needle-related procedures are the most important source of pain and anxiety in pediatric     patients. Consequently, needle-phobia and anxiety are common in children with auto-immune     disease and immune deficiency and may be barriers to adherence in treatment. The use of a     non-pharmacological and easy-to-use approach, like the Buzzy® device, could be an alternative     or adjuvant for the management of procedural pain and anxiety of these children during     needle-related procedures.      This study aims to determine the feasibility, acceptability and satisfaction of the Buzzy®     device for procedural pain and anxiety relief of immunology-rheumatology patients undergoing     needle-related procedures. The investigators will compare the Buzzy® device with an     anaesthetic cream (Maxilene®) during needle-related procedures. The investigators also plan     to assess feasibility outcomes and satisfaction of the nurses and the children with the use     of the Buzzy® device. This pilot study should refine or modify the research methodology and     improve the intervention being piloted before it's efficacy will be verified within a larger     scale-study.      The investigators strongly believe that the use of the Buzzy® device in immunology     rheumatology department could optimise procedural pain and anxiety management. Since most of     the treatments administered for auto-immune diseases and immune deficiency diseases are     through subcutaneous or intramuscular injections, pain and anxiety management using     non-pharmacological and/or pharmacological interventions should be prioritized. Given this     knowledge, the investigators feel that this pilot study has the potential to contribute to     pain and anxiety management of children undergoing needle-related procedures.   "
39273|NCT02771587|"     The main objective of the project is to assess whether there is an interaction between the     effects of ethanol and energy drinks on driving performance.      Secondary objectives include: to evaluate subjective effects (drunkenness) after     administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine     and taurine after alcohol and energy drinks administration and to assess if there is an     increased risk of bleeding when both drinks are taken together.   "
39274|NCT02771574|"     This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous     exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous     formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare     disease with unmet clinical need.   "
39275|NCT02771561|"     Obstructive sleep apnoea (OSA) is a condition which involves episodes of interrupted     breathing during sleep due to repetitive narrowing or collapse of the throat. These episodes     are usually associated with a drop in blood oxygen levels and brief awakenings, which disrupt     the sleep of those affected and can lead to daytime sleepiness. OSA is associated with an     increased risk of heart disease and stroke.      In some individuals, the low oxygen levels in the blood can be made worse by also having a     small hole in the heart, called a patent foramen ovale (PFO). This hole is present at birth     in everyone, but in some people (about 30% of the normal population) it fails to close.     Usually a PFO does not cause any medical problems. However, it may be recommended to have a     PFO closed by key-hole surgery if someone suffers a stroke, severe migraine or if they are     professional divers. There is a higher incidence of PFO in patients with OSA (25-50%)     compared to the wider population and this may account for some of the observed increased risk     of heart disease and stroke in patients with OSA.      This study will assess the number of patients with OSA who also have a PFO, and whether     closing the PFO can improve the symptoms of OSA (e.g. sleepiness, exercise capacity and     general well-being), thereby enabling the patient to not be reliant on treatment for OSA. If     the study shows that closing the PFO is beneficial then the investigators will assess in a     larger study if this treatment can also reduce heart disease and strokes.   "
39276|NCT02771548|"     Background      Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of the     knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in an     attempt to increase joint stability and facilitate athletes to return to sport (RTS).     Although ACLR is considered a relatively successful procedure, dynamic control risk factors     and strength and power deficits in the involved limb are still present after patients return     to sport.      Dynamic multi-plane, multi-joint actions such as jumping, landing, change of direction     cutting, have been shown to be common mechanisms of injury for the ACL in field sports .     Returning to multidirectional sports requires a proficiency and efficiency of movement when     carrying out these tasks. There is a lack of standardized, objective criteria to accurately     assess an athlete's ability to safely RTS. Therefore, there is a need for research that     simultaneously analyses sport specific dynamic tasks (3D motion analysis) and muscular     strength/power deficits that may explain poor outcomes following ACLR. This study aims to     further investigate movement patterns, limb asymmetry and muscle strength deficit in patients     post-surgery to identify risk factors for re-injury and criteria for RTS.      The purpose of this study was to:        1. Analyse kinematic (movement descriptors) and kinetic (forces that cause movement) during          sports specific dynamic tasks at different time-points (6 and 9 months) following ACLR.        2. To explore the association of those findings with those who re-injure, those who have          persistent knee pain or with those who fail to return to sport.        3. To compare the ACLR participants with age and gender matched healthy multidirectional          athletes.      It is hypothesised that biomechanical analysis will identify clear risk factors for poor     outcomes following ACLR. Analysis of ACLR athletes' biomechanics during sports specific tasks     will aid in the identification of athletes who are not yet ready to return to sport and will     inform the clinician of what must be targeted in specific rehabilitation protocols before     return to sport is considered.      Brief protocol      Participants will be recruited from patients who are scheduled to undergo anterior cruciate     ligament reconstruction at the Sports Surgery Clinic, Ireland. Healthy participants will be     recruited from local multidirectional teams. Participation will be voluntary and after     obtaining informed consent patients will be asked to complete pre-operative questionnaires to     ascertain injury information, and the function of their knee. During surgery the surgeon will     fill out an intra-operative questionnaire. Items recorded will include graft type, laxity,     involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or     chondral pathology.      Biomechanical assessment takes place at 6 and 9 months post surgery for the ACL group while     the healthy participants will be tested on one occasion. The 3D testing session will include     capturing of jumping, landing, hopping and cutting mechanics through the use of three     dimensional motion capture technology and force plates. Here reflective markers are placed on     the skin at anatomical landmarks. These markers are picked up by the infrared cameras and     tracked at 200 frames per second. Participants will make contact with a force plate with     their foot on undertaking the movements. Force and marker data will be combined to calculate     joint angles and moments. Participants will also perform a muscle strength test using     equipment called an isokinetic dynamometer. Both the operated and non-operated limbs will be     tested.      Participants will also be asked to fill out validated questionnaires to monitor self reported     knee function, their confidence in their knee and also collect data on any continuing adverse     symptoms such as locking, giving way, swelling or pain. Participants will also be asked if     and when they return to sport. Questionnaires will be administered to participants at pre-op,     3, 6, 9, 12 and 24 months post operatively.   "
39277|NCT02771535|"     Aim of the current study is to investigate the long-term efficacy of Metacognitive Training     for Depression (D-MCT) and to explore whether previously observed effects at the 6-month     follow-up of a randomized, controlled, assessor-blind, parallel group trial are maintained at     the 3-year follow-up.   "
39297|NCT02771262|"     Dyspnea, or uncomfortable labored breathing, is an important patient-reported outcome (PRO).     It is the primary and most disabling symptom of chronic obstructive pulmonary disease (COPD).     There is a high priority to improve dyspnea PRO assessment and predict exacerbations.     Frequent exacerbations are associated with increased disability, decreased quality of life     (QOL), and accelerated lung function decline.      Goals: To test the relative sensitivity to change, responsiveness and predictive validity of     a comprehensive dyspnea outcome computer adaptive test (CAT) that measures new anxiety and     activity avoidance domains and is more efficient to administer than existing dyspnea scales.      Expected Outcomes: Investigators expect to:        1. begin to transform how dyspnea is assessed;        2. improve dyspnea symptom management;        3. impact functional status;        4. improve QOL;        5. facilitate the earlier treatment and prevention of exacerbations;        6. improve COPD prognosis and survival; and        7. improve COPD healthcare utilization.   "
39278|NCT02771522|"     This is a prospective, single-centre clinical study to monitor caries lesion activity in     orthodontic patients with the Calcivis System over a 12 week period. Dentists will identify     patients who have had dental appliances in place for a minimum of 12 months and have visible     white spot lesions on the anterior surfaces of incisors and / or canines at de-bond.     Following de-bond, images of the tooth surface will be taken with the Calcivis System.     Presence or absence of elevated luminescence on the images will indicate activity /     inactivity. Only patients with at least one tooth identified as active with the Calcivis     System will continue in the study and be followed up at 2, 4, 8 and 12 weeks de-bond. Images     of the active teeth will be taken with the Calcivis System as before, at each follow-up     visit.      The percentage of teeth showing luminescence using the Calcivis System will be calculated and     summarised for all subjects for each post-baseline visit, and additionally by Investigator     and ICDAS score at Visit 1. For each subject the percentage of teeth with each ICDAS score     will be calculated. This will then be summarised over all subjects for each post-baseline     visit and the ICDAS score will also be cross-tabulated with the presence/absence of     luminescence from individual teeth for each visit.   "
39279|NCT02771509|"     The objective of the study is to assess the safety and efficacy of BB3 in preventing AKI     compared to placebo when administered to patients at risk for developing acute kidney injury     (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).   "
39280|NCT02771496|"     The Cohort is a multi-site prospective data collection study that will enroll any patient     with diagnosis of knee OCD (confirmed by a standard of care x-ray or MRI). Patients will be     followed for up to the next 50 years of their lives to study courses of care, disease     progression, treatment/surgical options/results, and specific sports-related outcomes in     athletic patients. Subjects will complete quality of life surveys as part of the Cohort.     Course of care will not be affected.   "
39281|NCT02771483|"     Giant cell arteritis (GCA) is a medium to large vessel vasculitis with a predilection for the     superficial cranial and intrathoracic arteries. Diagnosing the condition and predicting which     patients will develop large vessel complications remains a challenge. There are limitations     with temporal artery biopsy, magnetic resonance angiography and ultrasound of temporal     arteries and American College of Rheumatology classification criteria.      Positron emission tomography (PET) has been shown to be a useful modality in detecting     inflammation in large intra-thoracic vessels but previously has not been able to accurately     detect FDG uptake in the superficial cranial arteries due to poor spatial resolution. Newer     scanners can perform finer cuts of the head and can detect uptake in these arteries.      This study has three main components:        1. Cross sectional study assessing the accuracy of PET uptake in the superficial cranial          and intrathoracic arteries of suspected GCA patients for the diagnosis of GCA        2. Cohort study assessing the prognostic implication of FDG aortic uptake on aortic          diameter at 24 months        3. Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without          FDG PET uptake at 0, 6 and 24 months   "
39282|NCT02771470|"     Probiotics modulate the gut microflora and immune status in lung cancer who need     chemotherapy.   "
39283|NCT02771457|"     The primary purpose of the project is to determine what is the best schedule for restarting     infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis     and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint     would be the failure rate; the need to discontinue infliximab or change treatment. A     secondary aim will be to determine if infliximab drug and antibody levels can predict     clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and     long-term steroid free remission rate, and serum and fecal inflammatory markers in response     to infliximab.   "
39284|NCT02771444|"     This study aims to evaluate image quality of a low-dose tomosynthesis system versus a     comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator     and with the study device, and images will be assessed by several radiologists by comparing     details in the images from the two systems.   "
39285|NCT02771431|"     Our study would be the first randomized study investigating the use of video conferencing via     tablet computers versus traditional bedside rounding and its effect on clinical data such as     length of stay and complications as well as patient satisfaction. As technology improves,     medicine has an obligation to incorporate this technology to improve efficiency and     cost-effectiveness. If telerounding is proven to not change outcomes or patient satisfaction,     it saves time for the physician during office hours to see more patients or be productive in     other ways. Telerounding could be applied in remote areas with a dearth of specialists,     allowing these specialists' expertise to reach areas it could not before.   "
39286|NCT02771418|"     Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via     the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and     oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and     affect postoperative cognitive function. The goal of this study was to assess the effects of     anesthetics on perioperative cerebral oxygenation and cognitive functions.   "
39287|NCT02771405|"     The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients     will undergo treatment with different regimens of DAAs.   "
39309|NCT02771093|"     This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study     to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or     alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in     patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).   "
39310|NCT02771080|"     This is a retrospective observational study to assess the relationship between peak systolic     global longitudinal strain measured on pre-cardiopulmonary bypass trans-esophageal echo     images predicts post-operative low cardiac output syndrome defined as the need for an     inotropic support during 24 hours or longer.   "
39311|NCT02771067|"     The purpose of this study is to investigate the validity of pulse pressure variation to     predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.   "
39312|NCT02771054|"     Many HIV-infected individuals on effective antiretroviral therapy with suppressed HIV RNA     levels in blood as well as in cerebrospinal fluid have signs of low-level intrathecal     inflammation. Our aim is to study if changing the nucleoside backbone in an antiretroviral     regimen can decrease the residual intrathecal immune activation.   "
39298|NCT02771249|"     People with human immunodeficiency virus (HIV) often take several medicines to control HIV.     Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take.     They may also need to take medicines for an infection called latent tuberculosis (TB).     Researchers think a once-weekly treatment for latent TB would be easier for people with HIV     to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid.     However, they need to see how TB drugs and HIV drugs interact.      Objective:      To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs     together can be treated safely.      Eligibility:      Healthy adults ages 18 65.      Design:      Participants will be screened with a medical history and physical exam. They will have vital     signs taken and give a blood sample. Women will have a pregnancy test.      Participants cannot take any other medicines during the study, including vitamins. Only     occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin or     Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as Benadryl ,     Zyrtec , Claritin , etc.) will be allowed.      Participants will be assigned to one of three groups. Each group will take a different study     drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a     supply of the study drug tablets and instructions for taking them. Participants will keep a     medicine diary to serve as a memory aid for taking medicine and reporting any side effects     that they may experience.      Participants will have 8 or 9 study visits over about 40 days. The number of visits depends     on which group the person is assigned to. All visits will take place at the NIH Clinical     Center. Participants will fast before study visits.      The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last     for about 12 hours. The other 4-5 visits will last about 1 hour.      During all study visits, screening procedures will be repeated. During long visits, an     intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to     take blood.   "
44269|NCT02706236|"     The study purpose is to characterize the effect of pancreatic enzyme supplementation on     chronic pancreatitis type pain.   "
39288|NCT02771392|"     Corneal abrasion (CA) is one of the most common eye injuries, accounting for 10% of     eye-related emergency visits.1 A 1985 survey showed that around 3% of all visits to US     general practitioners were for corneal abrasions. In addition, in 2008, approximately 27,450     work-related eye injuries and illnesses occurred that caused missed time from work.1Due to     the large number of nerve endings even small corneal injuries can produce significant pain.     The discomfort is typically most pronounced in the first 24-48 hours, and in many cases     showed a loss in time at work and disruption of daily activities. The current standard of     care in the emergency department includes topical analgesia and antibiotics with a change to     oral analgesics upon discharge. Despite the ineffectiveness of oral analgesics in treating CA     pain, most physicians do not prescribe topical analgesics based on standard medical teaching.     The study's aim is to further investigate the role of tetracaine in the outpatient management     of CA utilizing models already established to ensure safety. To accomplish this investigators     will employ a prospective, double blind, randomized control model to compare undiluted 1%     tetracaine hydrochloride to normal saline in patients presenting to the ED with uncomplicated     corneal abrasions. Tetracaine will be supplied in three plastic prefilled, commercially     available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine     hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse).     Saline will also be supplied in three plastic prefilled, commercially available vials,     plastic bullets. Follow up visits or calls will be provide at 48 hour to reevaluate symptoms     an asses the patients perceived pain using VAS provided in participant introduction packet     during the informed consent process.   "
39289|NCT02771379|"     This study is a multicentre, prospective, non-interventional post-authorisation safety study     (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.      No medication will be provided as part of this study. Raxone® will be obtained through     commercial channels.   "
39290|NCT02771366|"     Cerebral energy metabolism declines with advanced aging, and is implicated in age-related     cognitive decline, Alzheimer's disease (AD), and other forms of neurodegenerative disease     (Parkinson's disease). In addition, age-associated increase in systemic and neuroinflammation     is associated with a higher likelihood for development of Alzheimer's disease and     neurodegenerative disease in older adults. Furthermore, decreased cerebral energy metabolism     and increased neuroinflammation are both associated with deficits in cognitive function, even     in the absence of neurodegenerative disease. In older adults, decreased cognition is strongly     associated with the development of AD, increased rates of hospitalization, loss of functional     independence, and increased mortality rate. Novel methods for preventing cognitive decline     and neurodegenerative diseases in older adults are needed the world's aging population.      Current research suggests that nutrients in fruits and vegetables produce strong anti-oxidant     and anti-proliferative effects. Most Americans are not consuming the minimum recommendations     of fruits and vegetables per day to receive these benefits. Whole food-based nutritional     products, such as Fermented Papaya Product (FPP), may provide a healthy alternative for     individuals. FPP, which is made by bio-fermentation of Carica papaya, has been found to     enhance antioxidant protection and to decrease DNA damage in healthy older adults.     Furthermore, if FPP increases cerebral energy metabolism and down-regulates     neuroinflammation, with resulting effects on cognition, dietary supplementation with FPP may     have preventative benefits for age-related cognitive conditions, including MCI, AD,     Parkinson's disease and other neurodegenerative diseases.   "
39291|NCT02771353|"     This study aims to compare the resource impact, acute toxicity and feasibility of different     pan-lymph node radiotherapy techniques. Radiotherapy using wide tangents with the patient in     breath hold will be compared against volumetric modulated arc therapy (VMAT) in free     breathing in the main trial. A parallel study will asses the accuracy of VMAT treatments     using voluntary deep inspiratory breath hold compared to an active breathing controlled     breath hold device.   "
39292|NCT02771340|"     The purpose of this study is to evaluate the safety, tolerability, biological activity,     pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal     doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo     enucleation or brachytherapy of the affected eye.   "
39293|NCT02771327|"     Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients     undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange     improve.   "
39294|NCT02771314|"     Based on the possibilities that both plasma and circulating tumor cells (CTCs) (the liquid     biopsy) may offer, we consider that it could be feasible to longitudinally monitor the     genetic evolution and the biologic characteristics of CTCs, by using Circulating tumor DNA     (ctDNA) and CTCs as a source of biologic material. This approach could provide information     regarding the genetic/molecular changes associated with primary and acquired resistance to     AZD9291 and, thus, to facilitate to more appropriately adapt the tailored treatment in this     particular group of NSCLC patients. It has been recently reported that the detection of     resistant clones, based on the tumor-associated genetic aberrations in the blood, can     identify treatment resistance up to 10 months earlier than the radiological methods     providing, thus, the potential for an early switch to a non cross-resistant therapy in order     to improve patients' outcome.   "
39295|NCT02771301|"     This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma     with IDH1R132H mutation.   "
39296|NCT02771288|"     To investigate the safety and long-term vascular remodeling after bioresorbable vascular     scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with     Kawasaki disease (KD).      Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Coronary     artery lesion is the predominant determinant of KD outcome in the long-term. Children with KD     with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of developing     a clinically significant stenotic lesion during follow-up. They are at risk of myocardial     infarction-related sudden death or congestive heart failure as young adults. Bypass surgery     could be the reasonable strategy but the long-term patency of the graft remains     unsatisfactory. Percutaneous angioplasty with drug-eluting stents (DES) implantation is the     alternative. However, metallic stenting remains problematic in several aspects mainly due to     the restriction of vessel expansive remodeling. The novel BVS has the potential to be free     from the limitation due to scaffold degradation.   "
39299|NCT02771236|"     Background:      Genes are the basic units of heredity. When genes are changed, certain cells don t work like     they should. Researchers want to try to better understand the genetic conditions that are     linked with inherited eye diseases.      Objective:      To try to identify the genes linked to the development of inherited eye diseases.      Eligibility:      People ages 4 and older who have or have a family member with an inherited eye disease      Design:      Participants will be screened with medical history and medical records.      Participants will have one visit that will take 3 4 hours. This will include:      Medical and family history      Eye exam: This includes the pupil being dilated.      Electroretinography: A small electrode is taped to the forehead. Participants sit in the      dark with their eyes patched for 30 minutes. Then numbing drops and contact lenses are put in      the eyes. They will watch flashing lights.      Blood tests      Saliva sample: They will spit into a container or have the inside of their cheek swabbed.      Genetic testing will be done on participants blood or saliva.      Participants may meet with the researchers to discuss their genetic tests.   "
39300|NCT02771223|"     Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation     abnormalities, most of which related to the direct, time dependent effect of the polymer     tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect     of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on     postoperative coagulopathy   "
39301|NCT02771210|"     The purpose of this study is to demonstrate efficacy, including effects on inflammation by     magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis     for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis     and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs     (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.   "
39302|NCT02771197|"     AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem     cell transplantation as a possible cure; however, many patients are not candidates for     allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of     available donors. Therefore, these patients are unable to receive the therapeutic benefits of     the graft-versus-leukemia effect of donor immune cells. The aim of this study is to     hopefully break immune tolerance to AML cells to provide better outcomes in patients with     non-favorable risk AML.   "
39303|NCT02771184|"     This clinical trial is conducted within the research project 'Computerized Lung Sound     Analysis'. The research goal is the development of a system enabling the automatic     classification of lung sounds, which will result in a decision support system for physicians.      The objective of this trial is to create a small lung sound corpus, enabling the development     of a prototype of the described system. Therefore, investigators record lung sounds with     several lung sound transducers distributed on the posterior chest of human test subjects.   "
39304|NCT02771171|"     CT and MRI based measurements of the pediatric airway has changed the age-old cone shape     concept of the pediatric airway and define airway shape as elliptical structure. The cone     shape was based on the cadaveric measurements done by Bayeux in 1897 and described later by     Eckenhoff in 1951.      The present study is based on three-dimensional CT images of the airway column replicating     the cylinders used by Bayeux for his cadaveric measurements. The purpose of this study was to     determine the cone shape of the pediatric airway.   "
39305|NCT02771158|"     The purpose of this study is to determine whether midodrine administration decreases duration     of intravenous vasopressors and intensive care unit length of stay for patients in septic     shock.   "
39306|NCT02771145|"     The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft     contact lens wearers of Japanese ethnicity. This study will be conducted in Japan.   "
39307|NCT02771132|"     The primary objective of this study is to compare the effectiveness of classroom-based     behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of     care intervention, on reducing the incidence of self-reported sexual assault among girls from     baseline.      Secondary objectives of this study is to determine the impact of the interventions on related     physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and     self-esteem.   "
39308|NCT02771106|"     Mild TBI subjects will initially be identified by providers in the Hennepin County Medical     Center (HCMC) TBI Clinic. The subjects will then undergo objective testing by the     developmental optometrist to confirm if they do or do not have vision dysfunction related to     the mTBI. At the Center of Magnetic Resonance Research (CMRR) located at the University of     Minnesota (U of M), the whole brain will be imaged using resting state and task functional     MRI and diffuse tensor imaging (DTI) using a high field 3 Tesla (T) MRI. The subjects will     then receive neurovision rehabilitation if they are in the vision dysfunction group. This     treatment is standard care. Both groups will then undergo repeat objective vision testing by     the developmental optometrist at 3 and 6 months to confirm that vision dysfunction has     resolved. Resting state and task fMRI and DTI will be done at the same time to compare     functional and structural connectivity changes between the 2 groups.   "
39313|NCT02771041|"     Arthroplastic hip surgery fast-track the subject of increasing interest and reduces the     average length of stay and improve patient satisfaction. This fast circuit implemented in     many schools uses dedicated inpatient units, preoperative patient education in     multidisciplinary groups (including physiotherapists, nurses, rehabilitation doctors and     surgeons), an analgesia protocol multimodal and a network dedicated to the outlet (1.2).      The investigators working hypothesis is that the mere realization of a preoperative visit a     week before the intervention would reduce the average length of stay for all patients with a     target of two nights (instead of 7.5 days currently) (3) to reduce the use of SSR during     hospitalization. This consultation would serve to explain to the patient the early course of     care, give advice and help to anticipate acts for its release post-operative as, for     example, contact a physical therapist and a nurse or check to their community pharmacy if     their heparin stock is enough and to answer any questions (Appendix 2: early information     given to the patient consultation J-8).      The investigators protocol is inspired by the one already in place for outpatient PTH and PTH     1 night but invariably apply to all patients for whom a home is considered output.   "
48188|NCT02654873|"     Cholecystectomy has been made with benign conditions usually. The aim of this study is to     compare the macroscopic evaluations of the cholecystectomy specimens with it's     histopathological examinations.   "
39314|NCT02771028|"     In this trial the investigators aim to establish whether Emotional Freedom Techniques (EFT)     can reduce cognitive complaints in cancer survivors. All consenting patients aged 18 years or     above, who have been diagnosed with a solid tumour of hematologic malignancy and who have     completed or are in the late phase of a chemotherapy, radiotherapy, anti-hormonal or targeted     therapy treatment, can participate in this trial. Patients should suffer from subjective     cognitive complaints based on a score of 43 or more on the Cognitive Failure Questionnaire     (CFQ). These patients will be randomly assigned to either the control or intervention group.     Patients in the intervention group will be scheduled to receive an 8-week EFT intervention     program. Other patients will be placed on an 8-week wait list after which patients will also     start the EFT program.   "
39315|NCT02771015|"     Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an     expected hospital stay for 4 days or more will be included in the trial. Individual trial     duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial,     i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be     assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).   "
39316|NCT02771002|"     The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral     perfusion in patients in septic shock and after cardiac surgery.   "
39317|NCT02770989|"     This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for     patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue     near the PV.   "
39318|NCT02770976|"     This study is to investigate the effect of a wide range of assistance levels on respiratory     pattern, breathing variability including tidal volume and peak inspiratory pressure during     neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to     explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal     amplitude, work of breathing and comfort of preterm infants.   "
39319|NCT02770963|"     This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients     with discogenic sciatica compared with sham acupuncture.   "
39320|NCT02770950|"     The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima     plaster for patients in knee osteoarthrosis post-marketing.   "
39321|NCT02770937|"     This is prospective randomized controlled study to compare the proficiency of novices in     acquiring laparoscopic suturing skills following either training in a virtual reality     simulator or box trainer.   "
39322|NCT02770924|"     The aim of this study is to evaluate the visual function of patients with bilateral     implantation of the IOL trifocal ZEISS AT LISA TRI TORIC by means of visual acuity tests with     and without optical correction, sensitivity curve contrast, defocus curve and quality     questionnaire visual function (VFQ-25).   "
39323|NCT02770911|"     The study evaluates the feasibility and advantage of modified laparoscopic double-staple     anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior     resection.   "
39324|NCT02770898|"     Evaluating the impact of probation on probationers is necessary for both effective practice     of probation officers and their assessment of the success of their work. At present, there     are limited studies that have evaluated the impact of probation services on probationers and     their family. There are even fewer studies that have examined interventions on probationers'     well-being and family relations in a Chinese society. Compared with the general population,     probationers are associated with poorer mental (e.g., depression, lower levels of     self-esteem, high level of stress) and physical health, and often experience higher levels of     family conflict, and poorer quality of family relationships. Given the vulnerabilities, there     is a need to strengthen and promote healthy lifestyle and enhance individual and family     well-being among probationers. As part of the FAMILY project, the current study focuses on     FAMILY Holistic Health which emphasizes a comprehensive approach to improving physical,     mental, and social health and well-being. This project will be conducted as a pilot project     in the Social Welfare Department (SWD) in the Eastern District of Hong Kong. Interventions     will be delivered to promote and enhance probationer's wellbeing, as well as enhancing FAMILY     3Hs (Happiness, Health, and Harmony). Training programs will be provided to probation     officers and/or workers of SWD in order to equip them with knowledge and skills in     implementing health-related family intervention programs.   "
39325|NCT02770885|"     Glucagon like Peptide -1 (GLP-1) receptor agonists are well known to stimulate     glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal     and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1 has     been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a     hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic     properties of GLP-1 might be of advantage in persons with an exaggerated thirst perception as     is the case in patients with primary polydipsia.   "
39556|NCT02767869|"     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult     population suffers the disease.      Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin     secretion.      The investigators hypothesis was that the the administration of resveratrol modifies the     metabolic syndrome, insulin sensitivity and insulin secretion.   "
39326|NCT02770872|"     Cardiovascular disease (CVD) is the leading cause of death in developed nations and a major     health issue in Veterans. Despite a number of different treatments, cardiovascular disease     remains a major health burden, thus further treatments are needed. Individuals with obesity     and/or diabetes are at particularly high risk for cardiovascular disease, and research     suggests that elevated levels of serum amyloid A (SAA) may contribute to cardiovascular     disease, particularly atherosclerosis. In preliminary studies in both mouse and human the     investigators have identified that SAA appears to shift between lipid particles. SAA is     mainly found on high density lipoprotein (HDL) particles; however, the investigators have     found that in both mice and humans with obesity and/or diabetes SAA is found on low density     lipoprotein (LDL) and very low density lipoprotein (VLDL) particles, and the investigators     hypothesize that the presence of SAA on LDL or VLDL makes these particles more likely to     cause cardiovascular disease. To determine what leads SAA to shift between lipid particles,     SAA knockout mice will be injected with HDL containing SAA then blood collected at several     time points over 24 hours, and the lipid particles will be isolated to measure SAA. In some     experiments the investigators will compare different isoforms of SAA, different types of HDL     particles, or induce expression of enzymes likely involved in shifting SAA between particles.     To determine if the presence of SAA makes lipid particles bind vascular matrix more strongly,     the investigators will collect carotid arteries and compare the extent of lipid particles     bound to the vascular matrix in the vessel wall when the particles have or do not have SAA     present. If this research confirms this hypothesis then the presence of SAA on LDL or VLDL     may 1) be a new marker indicating humans at highest risk for cardiovascular disease and 2) be     a new target of therapy to prevent cardiovascular disease.   "
39329|NCT02770833|"     The hypothesis is that seafood proteins given in combination with carbohydrates with low GI     are superior to seafood proteins in combination with carbohydrates with high GI and meat in     combination with both carbohydrates with low and high GI in promoting energy expenditure and     satiety. The overall objective of this study is to investigate the acute effects of meals     containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating     hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.   "
39330|NCT02770820|"     This phase I/II trial studies the side effects of laboratory-treated (central memory/naive)     cluster of differentiation 8+ T cells (autologous Wilms tumor [WT]1-T cell receptor [TCRc]4     gene-transduced CD8-positive central memory T-cells [TCM]/naive T cells [TN] lymphocytes) and     how well it works in treating patients with acute myeloid leukemia that is newly diagnosed or     has come back. Genetically modified therapies, such as autologous WT1-TCRc4 gene-transduced     CD8-positive TCM/TN lymphocytes, are taken from a patient's blood, modified in the laboratory     so they specifically may kill cancer cells with a protein called WT1, and safely given back     to the patient. The genetically modified T-cells have genes added in the laboratory to     allow them to recognize leukemia cells that express WT1 and kill them.   "
39331|NCT02770807|"     This is an international, multi-center, one-year, randomized, prospective, double-blind,     placebo-controlled, phase III study, designed to assess the effect of two non-overlapping     dose ranges of EDS EP, administered by IV infusion once per month, on neurological symptoms     of patients with Ataxia Telangiectasia.   "
39332|NCT02770794|"     This multicenter prospective clinical trial investigates the accuracy of ultrasound to     predict relapse after discontinuation of infliximab and the efficacy/safety of     readministration of infliximab in patients with rheumatoid arthritis in a low disease     activity state.   "
39333|NCT02770781|"     The purpose is to examine the feasibility and preliminary effectiveness of the role of a     personal trainer for non-metastatic breast cancer survivors to improve physical activity and     well-being (in terms of quality of life).   "
39334|NCT02770768|"     The purpose of the present study is to understand the neurobiological mechanisms of action     underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which     desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating     desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual     desire as a manipulation check. The investigators will address this goal using a double-blind     randomized outpatient design and determine the pre-post neurobehavioral change in the     Flibanserin group and investigate the extent to which Flibanserin normalizes brain activity     in premenopausal women with HSDD and the extent to which regional brain activation is     associated with changes in symptoms and behavior (as measured with self-report measures of     sexual desire and/or eye-tracking movements).   "
39335|NCT02770755|"     This registry study will compile information about patients who are scheduled to receive or     have received Adipose Derived Regenerative cells (ADRCs) prepared by Celution device to treat     muscle and ligament sports injuries.   "
39336|NCT02770742|"     This is a prospective, observational study to evaluate patient satisfaction with colonoscopy,     depending on whether sedation is used during the procedure or not. Patients will receive     questionnaires before the procedure to assess the potential influence of patient criteria and     after the procedure to assess satisfaction-scores and pain-scores. A validated satisfaction     score (Schoen et al.) will be used for the primary outcome. As secondary parameters, pain-     and sedation-scores will be assessed by the validated NAPCOMS score, as well as procedural     quality indicators. The study will assess, whether adequate selection in regards to risk     factors for sedated or unsedated colonoscopy, leads to similar satisfaction-scores within     both groups.   "
39363|NCT02770391|"     This is a research study to test an investigational drug (Not FDA approved), ARN-509 given in     combination with Leuprolide acetate (FDA approved) in men diagnosed with high-risk prostate     cancer who have already selected to have surgery to remove their prostate gland as part of     their treatment plan. The main purpose of this study is to determine how tumors make     androgens (male hormones), which makes these tumors more aggressive and resistant to hormonal     therapy and how a short period of treatment with ARN-509 and leuprolide acetate prior to     surgery can affect the production of these hormones in normal and malignant prostate tissue.   "
39364|NCT02770378|"     A proof-of-concept clinical trial assessing the safety of the coordinated undermining of     survival paths by 9 repurposed drugs combined with metronomic temozolomide (CUSP9v3 treatment     protocol) for recurrent glioblastoma   "
39365|NCT02770365|"     To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug     product in the treatment of vulvar and vaginal atrophy.   "
39337|NCT02770729|"     There has thus far been only one randomized and masked clinical trial in the world to     evaluate the efficacy of the intraoperative intracameral injection of antibiotics with the     objective of preventing endophthalmitis following cataract surgery. The ESCRS study from 2007     confirmed that the intracameral use of cefuroxime reduced the incidence of endophthalmitis     approximately fivefold. Unlike in Europe, where this drug came to be widely used after the     2007 results, cefuroxime is not commercially available in Brazil. Many studies around the     world have substituted cefuroxime with moxifloxacin, which is a drug that is easily found     around the world in eye drop form. It is widely used in postoperative regimens in cases of     ophthalmologic surgeries, and it is free of preservatives that are toxic to intraocular     structures (corneal endothelial cells). Three studies (all respective) found that the     intracameral use of moxifloxacin is safe and effective for preventing endophthalmitis     following cataract surgery; however, no controlled, randomized, and masked clinical trials     have been performed with this objective. If this trial confirms its hypothesis (a reduction     in the incidence of endophthalmitis following cataract surgery) and if minimal side effects     are reported, moxifloxacin may be an option for routine intracameral use during cataract     surgery, thus reducing cases of endophthalmitis and consequent cases of blindness.   "
39338|NCT02770716|"     This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo     in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.   "
39807|NCT02763540|"     Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD.     Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the     same time. Between observers agreement will be assessed for each pairs of samples.   "
39339|NCT02770703|"     Inguinal hernia repair can be considered as one of the most frequent surgeries in general     surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally     invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some     advantages and disadvantages. The posterior wall of the inguinal channel is usually     reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.      Two of the most frequent complications following hernia surgery are hernia recurrence and     chronic groin pain. Latter can occur in up to 10%. Both represent a considerable     socio-economic impact. While different surgical hernia procedures and mesh fixation     techniques have been evaluated as influential factors, the impact of mesh position and mesh     deformation on hernia recurrence and chronic groin pain is unknown. This may be even more     important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the     risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where     the mesh position is not under direct visual control.      Until now direct mesh visualization was impossible. A recent development of MRI visible     meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation     after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative     chronic groin pain the mesh position can now directly be identified with Magnetic Resonance     (MR) imaging preventing unnecessary explorative surgery.      In this study the investigators plan to perform MRI scans to assess mesh position and     deformation 90 days postoperatively and correlate it with the clinical status and pain score     (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh     position in relation to the operative technique, patients will be randomized to minimally     invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge     this is the first study investigating the impact of the three most common surgical hernia     procedures on postoperative mesh position and deformation and its correlation to the clinical     findings focussing on hernia recurrence and chronic groin pain.   "
39340|NCT02770690|"     While propofol is widely used an anesthetic induction medication, it causes the mild to     moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol     injection pain.   "
39341|NCT02770677|"     COPD patients will be recruited and randomly assigned into one of each group: 1) Control     group or 2) Yoga group. In Yoga groups, subjected will be asked to participate in Modified     Dantien Yoga training for 12 weeks (3 times/week, 60 min/time). The subjects will be     evaluated their pulmonary function, functional fitness performance, dyspnea score, and     quality of life at baseline and after 12 wk training.   "
39342|NCT02770664|"     Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126     immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment     Elevation Myocardial Infarction (STEMI).   "
39343|NCT02770651|"     The purpose of this study is to evaluate the incidence of late incomplete stent apposition     (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting     stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus     zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa,     CA, USA) implantation in patients with AMI at 12 months.   "
39344|NCT02770638|"     This study aims to establish clinical evidence for the use of scoop stretchers in the sports     setting for spinal immobilisation and transport compared to the traditionally used long back     boards through measuring tissue interface pressures over forty five minutes. All participants     will be placed on both the scoop stretcher and the long back board for forty five minutes     each, with at least 45 minutes between the two tests. A special mat that measures the     pressure of the body against the board will be used to determine the pressure forces at     certain points of the body touching the board (in mmHg). The participants will also be asked     every five minutes during the experiment to rate the comfort of the device. Pressure measures     from each participant on each board will be collated and assessed along with each     participant's reported pain scores and comfort rating. The measurements from the tissue     pressures will be analysed in real-time from the software connected to the pressure-mat and     therefore show if pressures increase over time. A comparison between boards will be made.   "
39345|NCT02770625|"     The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with     Type 1 Gaucher disease.   "
39346|NCT02770612|"     The specific aim of this study is to use a shared decision making tool to allow women who     have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will     be prescribed at discharge, within a range from 0-40 tablets. The study investigators will     document additional information from medical record abstraction (age, race/ethnicity, medical     and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic     management during CD, duration and complications of CD, length of stay, pain medication use     and pain scores on each postoperative day between CD and discharge). The investigators will     then follow up with the participants by telephone at two weeks after discharge to assess the     amount of opioid used, frequency of prescription refill, disposition of unused medication,     and participant satisfaction with their post-cesarean pain control. The investigators     hypothesize that the use of a shared decision making tool will decrease the amount of opioid     prescribed while still providing participants with satisfactory pain control.   "
39428|NCT02769546|"     The primary objective is to administer a cross-sectional survey to directly compare the     differences patients and physicians hold regarding ovarian cancer prognosis and survival,     complications arising from treatment, and counseling on advance directives, living wills,     palliative care, and hospice services. Overall, the project will pinpoint opportunities for     better patient physician communication regarding prognosis and end-of-life care and allow for     more informed and tailored decision-making.   "
39347|NCT02770599|"     Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn`s disease and     Ulcerative colitis) both complex disorders requiring a long-term management, with significant     healthcare resource consumption. Traditionally IBD patients has been treated by a variety of     health care professional including doctors with specialist qualifications, assistant doctors,     general practitioner or scarcity of follow-up-service. Lately there has been a shift in the     health care service from conventional follow - up (CF) to a rising numbers of health care     models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT-     models have been identified as important for continuity in patient centred care where nurses     have a key role within the team by enhancing patient care. Patients have directly access to     the IBD nurse who performing independently consultations at the IBD - Policlinic. This study     will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient     reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes     including adherence. This will be a retrospective clinical quality survey with a single time     point measurement, with consecutive recruitments of patients in the course of a 12-month     period. Data will be collected from medical records and patient questionnaires. Investigators     plan involving 300 participants aged >18 and < 80 recruited from Medical departments in North     Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD -     MDT. The study have approval from the local Ethics committee and application to the Data     protection Officer has been submitted. All participants are asked for provide written     consent. The results can potentially contribute; to a better utilization of health care     resources, improve quality of health and quality of care. In a nurse-perspective, this     organising model can be valuable in recruiting nurses by presenting a new challenging task     concept, and identify the gaps in their own knowledge and skills. A well-established MDT can     also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical     spaces for the gastroenterologist.   "
39349|NCT02770573|"     Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials,     nano-hydroxyapatite based, in the therapy of the dental sensitivity.      Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite&White     ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. The pain experience was     generated by a cold stimulus directly to a sensitive tooth surface and assessed using the     Visual Analogue Scale (VAS). The response was recorded before the application of the     materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and     12-week controls (POST-4).   "
39350|NCT02770560|"     Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to     inadequate dialysis dose, need to catheter replacement with as consequence progressive     exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution     to dissolve the clotting formed in of around the catheter lumen. There are few studies on the     optimal approach of TCC-related thrombosis with thrombolytic containing locking solution     (dose, number of administrations, timing of administration - intra or interdialytic use). The     primary objective of this retrospective study was to compare the efficacy of inter versus     intradialytic Urokinase containing locking solution on restoration of the TCC blood flow. The     investigators also assess the question of multiple administrations of Urokinase are more     efficient than one single administration   "
39351|NCT02770547|"     This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological     intervention that could improve the mobility and exercise tolerance of patients with     intermittent claudication. Thermotherapy is a simple, easily applicable therapy that enhances     exercise tolerance in patients with chronic heart failure by improving peripheral vascular     endothelial function.   "
39352|NCT02770534|"     The primary aim of this study is to investigate the reported enhanced coagulation status     (prothrombotic status) in patients with sickle cell disease using 2 laboratory tests;     thromboelastography (TEG) and Endogenous Thrombin Potential (ETP), and comparing the results     to healthy race matched controls to ascertain if there is a significant difference. Race     matching of the control participants is being carried out due to the well reported racial     differences in coagulation parameters that exist in healthy individuals. The investigators     are aiming to study the clotting state in sickle patients on regular transfusion therapy and     those on hydroxycarbamide, both treatments offered to sickle patients to ameliorate the     condition. The study will assess the reported prothrombotic state using TEG and ETP.   "
39353|NCT02770521|"     The aims of this study are to evaluate:        -  The safety and tolerability of a single dose of treprostinil given subcutaneously (as an          injection just under the skin)        -  The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a          single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.      The study has two parts. Participants may only enroll in one part.   "
39354|NCT02770508|"     The purpose of this study is to compare the safety and efficacy of a combination of a QD     regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir     boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated     tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve     HIV-1-infected patients eligible to start ARV therapy according to current     guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria     and none of the exclusion criteria.   "
39366|NCT02770352|"     The objective of this proposal is to create a database for obstetric fistula patients at     Bwaila Hospital containing their demographics, obstetric history, fistula history, physical     exam findings, intraoperative and postoperative results. Data collection will be prospective     starting in 2011 upon institutional review board (IRB) approval to last a minimum of five     years and will have a retrospective component tracing back to January 2010. Primary goals of     data analysis will be to determine the risk factors for fistula formation, risk factors for     poor surgical outcomes and long-term incontinence, social and economic impact of fistula     repair, and the ability of various physical exam findings to predict likelihood of successful     repair. It is expected that findings will lead to improved surgical management of obstetric     fistulas both locally and internationally.   "
39429|NCT02769533|"     This study is focusing on patients presenting with suspected malignancies of the pituitary     gland who are considered to be good surgical candidates.The primary end-point of the study is     to determine the sensitivity of OTL38 uptake and expression in identifying those nodules when     excited by an imaging probe.There will be a single dose of 0.025 mg/kg for intravenous     injection over approximately 60 minutes, two to three hours, prior to surgery.   "
39355|NCT02770495|"     It is assumed that gut inflammation and lesions characterizing flares of Crohn's disease (CD)     result from an aberrant T-cell mediated immune responses characterized by a complex balance     between peripheral and lamina propria regulatory and effector T cell subsets. Because most of     CD patients who undergo a surgery experienced a postoperative endoscopic recurrence of the     disease (70 % at one year) leading to a clinical recurrence (10 % per year), the model of     postoperative recurrence in CD represents a privileged situation that mimicks what happens in     the gut of CD patients in clinical remission before the occurrence of further flares. It is     likely that the same factors which underlie the immunopathogenesis of CD at its early stages     also contribute to disease recurrence in the postoperative setting. Indeed, the postoperative     state is performed for intent of disease remission and this situation represents probably an     ideal setting to investigate the dynamics of most of T cell subsets in the peripheral and     mucosal compartments because one may argue that removal of the diseased segment of bowel     resets the disease to its earliest phases, providing an interesting window to better     understand which T cell subsets predispose to disease recurrence.      That is the reason why this model will be used in the present project i) to understand better     the immunopathogenesis of CD relapse; ii) to identify novel and promising immune     cell-associated biomarkers capable to predict relapse of the disease and finally iii) to     identify potential specific therapeutic target associated with T cell subsets involved in the     initiation of disease.   "
39399|NCT02769923|"     The investigators will assess the usability and immune response following fractional dose     inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID     adapter by West Pharmaceutical services Inc. and Star Intradermal syringe by Star Syringe     Ltd.) and compare the response with the one achieved with fIPV administered with traditional     BCG needle syringe.   "
39356|NCT02770482|"     The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal     fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has     justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant     results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this     challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40     (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate     the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the     total amyloid burden. Literature data on this topic are sparse and to date, no report has     been published evaluating the utility of this marker in the diagnostic strategy for AD.   "
39357|NCT02770469|"     The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education     and Relationships) program was to examine the effectiveness of one of the first     linguistically and culturally tailored intervention programs to increase quality of life     among Korean American breast cancer survivors.   "
39358|NCT02770456|"     This randomized controlled trial with fish oil supplementation to pregnant women conducted in     areas of China, which are generally low in fish intake and low income, aims at answering the     following primary questions:        -  Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth        -  Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth        -  Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of          spontaneous delivery in the preterm period   "
39359|NCT02770443|"     Randomized study of medication withdrawal in patients who have recovered LV function in     Dilated Cardiomyopathy.   "
39360|NCT02770430|"     Steroids are still the first line treatment for established severe     acute-graft-versus-host-disease (aGVHD), with a response rate of 30-50%, and there is no     established and effective therapy for severe steroid-refractory (aGVHD). The outcome for     patients is poor and overall survival low, with few patients alive at 2 years.      In the case of failure after corticosteroid treatment, different therapeutic options have     been introduced as second or third-line strategies. In this scenario, infusion of ex vivo     expanded mesenchymal stromal cells (MSCs) has emerged as an additional tool for treatment of     GVHD.      The purpose of this work is conduct a study in patients with refractory and/or resistant GVHD     corticosteroids treatment. It will be randomized into two groups: one group that will receive     the MSCs and the other group will follow the acute GVHD steroid-resistant and/or refractory     treatment according to the routines of the Bone Marrow Transplantation (BMT) service of     Hospital de Clinicas de Porto Alegre. It will be evaluated aspects of immune recovery early     after MSCs infusion.   "
39361|NCT02770417|"     Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD)     suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a     combination of physical inactivity and muscle oxidative stress. Pilot data (not published)     clearly show that patients with COPD have significantly lower carnosine, which is a pH     (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared     to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in     trained and untrained healthy subjects. This study will assess if muscle carnosine can be     augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive     beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be assessed     to compare baseline muscle carnosine levels.      The aims of this study are to:        1. Investigate baseline muscle carnosine levels to confirm the pilot data in a larger          sample of patients with COPD compared with healthy elderly subjects        2. Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients          and whether it has an influence on exercise capacity, lower-limb muscle function and          quality of life        3. To investigate baseline and post supplementation structural and metabolic muscle          characteristics and markers of oxidative stress and inflammation in COPD patients and          it's association with muscle carnosine levels   "
39362|NCT02770404|"     This is a Phase 1, randomized, double-blind, single-center, placebo-controlled,     sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in     Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or     placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to     receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover     period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or     400 mg, respectively, of nafithromycin or matching placebo on Day 1.   "
39381|NCT02770157|"     A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short     children born small for gestational age.   "
39382|NCT02770144|"     The investigators have partnered with financial coaching organizations to establish what the     investigators have termed a Medical-Financial Partnership (MFP) that offers financial     coaching to improve financial and mental health.The investigators will evaluate the MFP's     impact on child overall health rating.   "
39367|NCT02770339|"     The purpose of this study is to determine the proportion of children presenting to a     pediatric emergency department with an acute mental health/behavioral crisis or clinical drug     toxicity who have a match or mismatch between the genes for drug metabolizing enzymes and     their current or recent drug therapy. The investigators will utilize a readily available and     FDA-approved cheek swab DNA test --GeneSight®--in these children that categorizes patients     into 3 different type of groups - RED, YELLOW, and GREEN based on individuals' abilities to     metabolize psychotropic drugs . Specific objectives include:        -  The relationship of genomic mismatch to serum drug concentrations, either low or high        -  The proportion of children with a genomic mismatch who present to PED with intentional          self-injury.        -  The relationship between match versus mismatch and self- and caregiver-reported outcomes          of functioning, drug efficacy, and drug tolerability.        -  Examine the proportion of children/adolescents who present to PED with an adverse drug          reaction to one or more psychotropic with a genomic mismatch.        -  Quantify the specific adverse reactions related to a mismatch of genotypes.   "
39368|NCT02770326|"     The purpose of this study is to test the safety of FMT in patients with C. difficile and     cancer. In previous other studies, FMT has been shown to cure C. difficile when antibiotics     have failed, but most of these studies have not included patients with cancer. The     investigators want to prove that FMT is safe in this group of people so that doctors will     feel more comfortable prescribing it for their patients with cancer.   "
39369|NCT02770313|"     The goal of this study is to determine how effective repeated fasting over 26 weeks (6     months) is at improving risk parameters that are surrogate endpoints for cardiovascular     diseases, metabolic dysregulation and cognitive impairments.      Subjects will be randomized 1:1 to water-only fasting or to their ad libitum usual diet, with     randomization performed within strata based on fasting history (≤180 hours or 181-720 hours     of total fasting for >12 consecutive hours per episode in the previous two years). Subjects     will be assessed at 4, 13 and 26 weeks following randomization.   "
39370|NCT02770300|"     The primary goal of this project is to test the safeness and clinical effectiveness of a     novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed     at Wearable Robotics srl, for the force assistance of stroke patients during     robotic-rehabilitation.      The secondary study aim is to design and test an automatic personalized robot-based upper     limb motor rehabilitation protocol targeting the specific kinematic performance of each     patient.      Finally, the study also aims to define the neuro-biomechanical state of the patient and its     evolution during the therapy by studying cortical signals and muscular synergies. This     information will be used to improve the personalization of the robotic treatment by targeting     not only the motor performance but also the cerebral and muscular activity of the patient.      The study is longitudinally designed in order to test the safeness and clinical effectiveness     of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized     robotic therapy from the beginning until the end of the treatment. Moreover, in order to     estimate the long-term clinical effectiveness of the treatment, the assessment methods     proposed in the clinical trial will be repeated one month after the end of the treatment.   "
39371|NCT02770287|"     The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons     pubis and Labia, and will result in improvement in general skin appearance including an     improvement in skin irregularities and skin laxity.   "
39372|NCT02770274|"     To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg     twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients     undergoing peripheral angioplasty or stenting or both for the management of peripheral     arterial disease.   "
39373|NCT02770261|"     The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy     in patient with hypertension and primary hypercholesterolemia.   "
39374|NCT02770248|"     The purpose of this study is to evaluate differences between treatments in mean change from     baseline in 24-hr IOP at Week 4.   "
39375|NCT02770235|"     In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An     association was shown between AGE measured by biopsy (invasive) and DE patients with diabetes     (increase of AGE level in the corpora cavernosa). To date no studies have explored the link     between DE and the measure of AGE by a non-invasive method of Auto-fluorescence (AF) Skin     (AGEReaderTM).      If the hypothesis of an association between DE and AGE measured by AF was checked, screening     for erectile dysfunction and measurement of AGEs could help to improve the overall management     of diabetic patient (including cardiovascular) and their quality of life.   "
39376|NCT02770222|"     The primary objectives of this 2-part drug interaction study are as follows:        -  To evaluate the effect of gemfibrozil on the pharmacokinetics (i.e., amount in the          blood) of selexipag and its metabolite ACT-333679 (Part I).        -  To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its          metabolite ACT-333679 (Part II).   "
39377|NCT02770209|"     This study is aimed at evaluating the feasibility and effectiveness of a completely natural     tissue engineered cartilage, composed of a self-made tissue engineered oriented scaffold and     autologous chondrocytes, for repairing articular cartilage damage following injury. And it is     also aimed at investigating the safety of tissue engineered cartilage transplantation.   "
39378|NCT02770196|"     The purpose of this study is to better understand how participation in cost-subsidized     community supported agriculture programs paired with tailored education can affect diet     quality and energy balance among children in low-income households.   "
39379|NCT02770183|"     The rational of the study is the description of the evolution of systolic cardiac function     post-stunning, evaluated by transesophageal minimally invasive echocardiography (hTEE). The     uses of these non-invasive methods have proved to be accurate for the qualitative and     semi-quantitative determination of the contractile function of the left ventricle and the     volume status of the patient. Furthermore the use of this technique has been demonstrated to     be a reliable method to analyze the stunning recovery infarction after controlled cardiac     arrest during the extra-corporeal circulation.   "
39380|NCT02770170|"     The overall purpose of the study is to assess the efficacy of three different doses of BI     655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus     nephritis in order to characterize the dose-response relationship within the therapeutic     range, and select the target dose for phase III development.   "
39384|NCT02770118|"     The goal of this proposed research is to test the hypothesis that long-term mild sleep     restriction (SR), as occurs frequently in adults and adolescents, leads to a positive energy     balance and weight gain.      Aim 1. To determine the effects of SR, relative to habitual sleep (HS), on food choice and     energy intake (EI) in adults at risk of obesity.        -  Hypothesis 1a. EI, assessed by multiple weekly 24-hour recalls, will be greater during a          period of SR relative to HS. This will be mostly due to increased fat and carbohydrate          intakes.        -  Hypothesis 1b. Neuronal responses to food stimuli, assessed by functional MRI (fMRI)          after 6 weeks of SR or HS, will indicate increased activity in networks associated with          reward and food valuation (insula, orbitofrontal cortex) during a period of SR relative          to HS. These responses will be correlated with intakes of high carbohydrate and high fat          foods (hypothesis 1a) and neuropeptide Y (NPY). Moreover, activation of the default mode          network (DMN) will be suppressed to a lesser extent after SR compared to HS.      Aim 2. To determine the effects of SR, relative to HS, on energy expenditure (EE) via     independent and complementary approaches.        -  Hypothesis 2a. EE, assessed by doubly-labeled water (DLW), and physical activity level,          monitored daily by actigraphy, will be lower during SR relative to HS.        -  Hypothesis 2b. Brown adipose tissue (BAT), assessed by positron emission tomography and          magnetic resonance combined scanner (PET/MR) using 18F-fluorodeoxyglucose (18FDG-PET)          and fat fraction (FF) measurement under cold stimulation, will be greater after SR          relative to HS. This would suggest higher adaptive thermogenesis after SR compared to          HS. BAT activation will also be correlated with NPY.      Aim 3. To determine whether SR alters body weight and adiposity relative to HS.        -  Hypothesis 3a. SR will lead to weight gain and increased total adiposity, as assessed          using magnetic resonance imaging (MRI), relative to HS.        -  Hypothesis 3b. Increased adiposity after SR will be correlated to an adverse          cardio-metabolic risk profile (increased glucose, insulin, triglycerides, leptin,          reduced high-density lipoprotein cholesterol and adiponectin) and neuronal responses to          food stimuli (Hypothesis 1b), and EE (Hypothesis 2a & 2b). Failure to stimulate BAT with          SR will be associated with greater gain in adiposity.   "
48856|NCT02646150|"     This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging     to qualitatively assess adequate distal perfusion after endovascular revascularization in     Critical Limb Ischemia   "
39385|NCT02770105|"     L-theanine and caffeine are nutritional compounds that are naturally found in tea. Our recent     findings using an EEG paradigm are consistent with the findings of others, indicating that     intake of L-theanine and caffeine reduce the time needed for a person to differentiate     between two visual stimuli and react to only one stimulus. In order to understand how these     compounds give rise to these improvements, the investigators need to study how these     compounds are related to various areas of the brain. To achieve this, the investigators plan     to scan the brains of nine participants after they take either 1) L-theanine alone, 2)     caffeine alone 3) the combination of both L-theanine and caffeine as compared with a placebo     (distilled water), to see which has the greatest impact on attention and on regions in the     brain that bring about attention.   "
39386|NCT02770092|"     Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic     obstructive pulmonary disorder (COPD), negatively influencing their quality of life,     treatment response and survival. Loss of muscle protein is generally a central component of     weight loss in CHF and COPD patients, but patients also have reductions in fat mass and bone     density, independent of the severity of the disease state. The purpose of this study is to     provide detailed insight in disease related gut function by obtaining information on gut     permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients     compared to matched healthy controls. This will provide required information that is     necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD.   "
39387|NCT02770079|"     Aim of the study:      To define insulin requirement during pregnancy and to identify the rapid changes in insulin     sensitivity around parturition and the first 6 months post partum. Such knowledge would be     clinically useful and markedly improve insulin treatment before and after parturition for     women with type 1 diabetes and serve to identify the best possible timing of testing women     with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.      Method:      Botnia clamp in women before, immediately after delivery and 6 months post partum. The     investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6     months post partum with 20 normal women investigated at the same time points. In addition the     investigators will collect feces samples from the mother and baby in order to determine     microbiota.      Perspectives:      Diabetes is a common condition with important implications for pregnancy outcome and     long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is     expected to have beneficial consequences both for the pregnant women and the future     generation.   "
39388|NCT02770066|"     A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA)     in high-risk patients with renal artery stenosis selected on the basis of common national     criteria, and with a common follow-up protocol for all three Danish centres offering PTRA   "
39389|NCT02770053|"     The purpose of this study is to determine whether enlarging the apical foramen causes     postoperative pain in teeth with necrotic pulp and apical periodontitis.   "
39390|NCT02770040|"     The purpose of this study is to identify whether an Accelerated or Intensified Infliximab     induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an     open label multi-centre randomised controlled trial.   "
39391|NCT02770027|"     After obtaining approval from the Institutional Review Board of our institution, written     informed consent is obtained from patients undergoing colon surgery are enrolled in this     prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES     (n=15).      All recruited patients will be given patient identification number (PIN) for the present     study of 01-30 according to their order of interview and recruitment. Investigators will     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30     (Envelop number).      According to the color of the card, attending anesthesiologists will give crystalloid for     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.      Patient data and statistical analyses:      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be     determined from the patients' medical record after patient's discharge.      All statistical analyses will be performed after the 30th patient's discharge and data     acquisition   "
39392|NCT02770014|"     Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation)     in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study.      This research study is evaluating a new blood test that is capable of detecting an EGFR     mutation in cancer without a biopsy.   "
39430|NCT02769520|"     The purpose of this study is to determine whether pembrolizumab, when given after salvage     surgery, is effective in increasing the time a person with squamous cell cancer of the head     and neck remains disease-free following locoregional disease recurrence.   "
39431|NCT02769507|"     The present study aims to investigate whether transcranial direct current stimulation (tDCS)     reduces auditory hallucinations in patients with psychosis. In addition, the neuronal changes     of tDCS will be examined.   "
39393|NCT02770001|"     Background: In genetic studies, the quality of DNA samples is tested first. Samples that are     low-quality are not used. Some studies involve minority ethnic groups. And example is admixed     African American. These studies often have small sample sizes. It is important to make sure     samples are not discarded unnecessarily. This may happen by using quality control (QC)     thresholds for homogenous groups. These may not be appropriate for an admixed group.     Researchers want to study samples that failed certain QC tests. They want to see if this has     to do with the ancestry of the outliers or the quality of the samples.      Objectives:      To study samples that fail heterozygosity and sample genotype call rate QC. To see if the     failing rates have to do with the ancestry composition of the outliers or the quality of the     samples.      Eligibility:      No new participants. Researchers will review data that has already been collected.      Design:      Researchers will study DNA samples in a lab.      The samples will not include data that can identify the person the sample came from.   "
39400|NCT02769910|"     The purpose of this project is to investigate the effect of capsaicin-induced neurogenic     inflammation with three different intensities on itch subsequently induced by histamine and     cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation     significantly increases susceptibility to itch provocations with cowhage and histamine.   "
39394|NCT02769988|"     Background:      The Teen Health Information Literacy Project is an after-school program for high school     students. It gives them skills to access valid and reliable health data. It also aims to grow     young health advocates. Researchers want to find out more about the impact the program has     had on students. They want to use this feedback to improve the program.      Objective:      To gain feedback about the Teen Health Information Literacy Project.      Eligibility:      Young people who participated in the Teen Health Information Literacy Project. The project     was run by Area Health Education Centers (AHECs) and sponsored by the National Library of     Medicine (NLM).      Design:      The study will be explained to students during a program session. They will take consent     forms home to their parents.      Participants will split into 6 focus groups. Each one will be conducted at an AHEC project     site.      The focus group will be a 90-minute discussion between participants and an evaluator from the     NLM. The evaluator will be present either in person or by video conference.      The evaluator will ask participants questions, which may include the following. What did they     like and dislike about the program? Why did they decide to participate? What have they     learned? Would they recommend this program to another student? How has the program affected     their interest in health-related careers?      The discussion will be audio-recorded. The evaluator will use an automated tool to convert     recordings into text. After that, she will destroy the audio.   "
39395|NCT02769975|"     Background:      Endocrine glands give off hormones. Researchers want to learn more about the disorders that     affect these glands in children. These disorders might be caused by changes in genes. Genes     contain DNA, which is the blueprint of how a cell works. Researchers want to identify the     genes involved in endocrine and metabolic disorders. This might help develop new ways to     diagnose and treat the disorders.      Objective:      To study the inheritance of endocrine or metabolism disorders.      Eligibility:      Children ages 0 18 with known or suspected endocrine or metabolism disorders.      Family members ages 0 100. They may participate in the DNA part of the study.      Design:      Participants will be screened with a review of their medical records. Their parents or     guardians will allow the records to be released.      Participants will have a clinic visit. This may include a physical exam and medical history.      Parents or guardians will give their consent for the study. Participants may have tests,     surgery, or other procedures to help diagnose or treat their condition. These could include:      Blood, urine, and saliva tests      Growth hormone test      Pituitary and adrenal function tests      Picture of chromosomes      Imaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey.      Genetic tests      Sleep study      Medical photographs      If surgery is done, a tissue sample will be taken.      Participants may have follow-up visits for diagnosis and treatment.      Participating relatives will have one visit. This will include medical history and blood and     saliva tests. The blood and saliva will be used for DNA testing.   "
39396|NCT02769962|"     Background: CRLX101 consists of a sugar molecule cyclodextrin linked to a chemotherapy drug     called camptothecin. The combined molecule or nanoparticle drug conjugate travels through the     blood. Once inside cancer cells, the chemotherapy drug is released from the molecule.     Olaparib is a drug that may stop cancer cells from repairing the DNA damage caused by     chemotherapy. Researchers want to see how safe it is to give CRLX101 and olaparib together     and to see how well the combination treats a specific type of lung cancer called small cell     lung cancer (SCLC).      Objectives:      To test the safety and maximum dose of CLRX101 and olaparib together. To test how well they     treat small cell lung cancer.      Eligibility:      Adults 18 and older with small cell lung cancer.      Design:      Participants will be screened with standard cancer care tests.      Participants will get the 2 study drugs in 28-day cycles. CRLX101 will be given every 2     weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a     day most days. Participants will keep a pill diary.      For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits.      At study visits, participants may have:      Blood and hair samples taken      History and Physical exam      Questions about health and side effects      Pregnancy test      Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. .      CT scan      Injection of CRLX101 (twice per cycle)      <TAB>Olaparib prescription <TAB>      Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will     have a physical exam and blood tests. They may have a tumor biopsy. The study team will call     the patient every 3 months for follow up after completing the study treatment.   "
39397|NCT02769949|"     Background: Some patients with unusual genetic conditions are referred to the National     Institutes of Health (NIH). They may not be eligible to join current research studies.     Testing such patients is a good way to improve the skills of research staff. The findings     could lead to new processes and research.      Objectives:      To recruit a diverse group of pediatric subjects with genetic disorders. To give clinic staff     hands-on experience working with these patients.      Eligibility:      Children any age with a known or suspected genetic disorder.      Design:      Participants will be screened with medical history and physical exam. They may have lab and     other tests.      Family members may give DNA samples.      Participants will have:      Medical history      Physical exam      Height, weight, and other measurements taken.      A clinical evaluation of their disorder.      They may have:      Blood, urine, and saliva samples taken      Imaging tests. These may include x-rays, scans, ultrasound, or skeletal survey.      A sleep study      A visit with other specialists at NIH      A genetic test from a commercial lab      Medical photographs taken      Other tests      Participants may have follow-up visits. They may get medical or surgical treatment.   "
39398|NCT02769936|"     Impairments in plasticity and working memory in schizophrenia have been hypothesized to     reflect dysfunction at the N-methyl-D-aspartate glutamate receptor (NMDAR). However, the     specific mechanisms through which the NMDAR is involved in working memory versus plasticity     differ. Towards gaining a deeper understanding of how NMDAR signaling relates to individual     cognitive functions in healthy adults and patients with schizophrenia, the investigators used     a single dose of d-cycloserine (DCS) as an experimental probe to examine the effects of     enhancing NMDAR signaling on plasticity versus working memory in healthy adults and     individuals with schizophrenia.   "
39456|NCT02769182|"     The main objective of this research is to develop and validate a technology-based solution     that addresses the diminished mobility, increased fall risk and impaired cognitive function     that are so common among older adults, enabling them to live longer successfully and     independently.   "
39401|NCT02769897|"     The study aims to evaluate the possible effects of an exercise program, nutritional and     psychological, postural orientation and guidance of oral health on body composition, physical     activity levels and lifestyle, physical fitness and health and motor performance, the factors     risk of cardiovascular disease, eating habits, the cognition levels, the psychological     profile, the body posture of children and adolescents with overweight and obesity,     considering the presence of risk genotype associated with the development of obesity. In     addition, identify the effects of orientation for oral health on the quality of life and     healthy oral habits.   "
39402|NCT02769884|"     This study trials a prototype artificial pancreas system that consists of a Roche insulin     pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model     probabilistic predictive control) algorithm housed on an android cell phone. The system doses     insulin based on CGM sensor glucose levels and the experimental algorithm.      The aim of this clinical study is to determine the efficacy of the MMPPC controller in     adolescents and adults with type 1 diabetes in a hotel setting.   "
39403|NCT02769871|"     The investigators aim to examine the effect on smoking cessation rate by showing stroke     patients who are active smokers images of their strokes.   "
39404|NCT02769858|"     The proposed study aims to establish the feasibility of light therapy for postpartum     depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate     relationships between circadian shifts and mood changes using a novel, home-based circadian     biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).   "
39406|NCT02769832|"     The purpose of this research study is to see if Abraxane and Gemcitabine given together will     be effective in treating small cell lung cancer that has progressed after one line of     treatment.   "
39407|NCT02769819|"     This study is designed to identify patients' features predictive of difficult endotracheal     intubation using a flexible fiberscope.   "
39408|NCT02769806|"     The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM     patients undergoing post-operative MRI for monitoring of tumor progression.   "
39409|NCT02769793|"     The purpose of this study is to determine whether levodopa/benserazide dispersible is     effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.   "
39410|NCT02769780|"     Nexus is a collaboration between academic institutions, advocacy and industry to answer     important questions about narcolepsy. It is a web-based observational study of     patient-reported outcomes in adult patients with narcolepsy, with follow-up every six months.      Nexus website: www.narcolepsyregistry.com   "
39411|NCT02769767|"     HLA-DRB1 * Gene and some genes involved in inflammation and immunity (IL-7R, GPC5, CTSS) have     been linked to risk of MS and the response to treatment with immunomodulators. This research     aims to estimate the risk that confers some variations in the sequence of these genes.   "
39412|NCT02769754|"     This prospective randomized study aims to determine the influence of the use of local     hemostatic on the incidence of local complications derived from the edge of transection:     biliary fistula or bleeding, after scheduled hepatic resection.   "
39413|NCT02769741|"     This study will assess the nutritional effect of cashews on LDL-C concentrations and     secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and     women with moderately elevated cholesterol.   "
39414|NCT02769728|"     The aim of the study is to explore short and longer-term effects of the Endobarrier™     implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps.     In addition changes in gut peptides and gut permeability after implantation of a removable     duodeno-jejunal bypass device to induce diabetes remission in obese subjects with     sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body     weight and body composition, the change in global cardiovascular risk from baseline to 12     months, estimated using the UKPDS risk engine will be recorded.   "
39415|NCT02769715|"     Removable partial dentures (RPDs) are traditionally fabricated by lost-wax casting technique,     a time-consuming and very laborious manual technique. Recently, fabricating removable partial     dentures using computer designing and laser sintering techniques have been introduced. The     purpose of this study was to evaluate the patient satisfaction with new computer-generated     removable partial dentures and compare it to the traditional removable partial dentures.   "
39432|NCT02769494|"     This study aims at evaluating efficacy and safety of topical using Mesalazine     Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's     disease.   "
39433|NCT02769481|"     The purpose of this study is to investigate the effect of bexagliflozin compared to     glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in     subjects with type 2 diabetes mellitus (T2DM).   "
39660|NCT02766504|"     the study aims to evaluate the role of airway ultrasound as a new evolving modality in     assessment and management of airway in surgical patients   "
39416|NCT02769702|"     Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis     often responds adequately to topical corticosteroids, there are many patients for which this     treatment is either inadequate or not tolerated. A patient with inadequate response to     treatment would manifest uveitis activity by slit lamp examination determination of anterior     chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension     (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid     administration, leading to glaucoma and permanent visual loss. Moreover, systemic     corticosteroids may be required at a dose unsafe for chronic administration. In these     situations, an immunosuppressive medication is often added as a steroid-sparing agent. If     and when there is clinical response to the added immunosuppressive, the oral and/or topical     corticosteroid dose can be reduced or eliminated to avoid toxicity.      There are several reasons for believing that Acthar might be beneficial in the treatment of     uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has     another important mechanisms of action mediated by its binding of melanocortin receptors.     Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In     animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory     cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there     is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules.     In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of     VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal     tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin     receptor binding by Acthar.   "
39457|NCT02769169|"     The purpose of this study is to determine whether double-dose Ranibizumab are effective to     regress the polyps and benefit to the visual outcome in the polypoidal choroidal vasculopathy     (PCV).   "
39417|NCT02769689|"     Progressive multifocal leukoencephalopathy (PML) is the most feared complication when     natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of     PML increases after 18 months of treatment. When switching from NTZ to another disease     modifying treatment (DMT) in these MS patients with an active disease, there is a high risk     of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary     before initiating a new DMT.      The primary purpose of this protocol is to investigate the impact of high dose of oral     methylprednisolone, given once a month during the washout period between NTZ and Fingolimod     (FTY).   "
39418|NCT02769676|"     The current postpartum care model of a single visit 4-6 weeks after delivery does not     optimally address contraceptive needs. By this visit, many women have resumed sexual     activity, potentially putting them at risk for unintended and rapid repeat pregnancy. In     addition, many women with pregnancy-related Medicaid lose insurance coverage at this time,     making it difficult to obtain long-acting reversible contraception (LARC) if desired.     Therefore, an earlier postpartum visit may remove barriers to improve access to LARC thereby,     reducing unintended and rapid repeat pregnancy. Our primary objective is to determine whether     an additional 3-week postpartum visit, compared to usual postpartum care, will affect the     initiation of LARC by 6 weeks postpartum.   "
39419|NCT02769663|"     The study assesses cognitive complaints in newly diagnosed patients with obstructive sleep     apnea with no medical-comorbity affecting cognition. Cognitive complaints will be compared to     healthy controls matched on age, sex and educational level. Factors related to cognitive     complaints will also be assessed, including anxiety and depressive symptoms, complaints of     fatigue and sleepiness, quality of life, psychological coping strategies and objective     measures of cognition. Patients starting treatment for sleep apnea (continuous positive     airway pressure or mandibular repositioning device) will be reassessed on all measures after     6 months of treatment to study the impact of treatment as usual on cognitive complaints and     its related factors.   "
39420|NCT02769650|"     The hypothesis of this study is that Stress-MRI is a clinically significant method of     myocardial perfusion assessment after coronary angioplasty with stenting of right coronary     artery (RCA) chronic total occlusion (CTO) is performed.   "
39421|NCT02769637|"     Mucus in the airways of patients with CF represents an area for bacteria proliferation,     microbial infection and inflammation. Similar to the lung, the esophagus provides an     environment for bacterial to grow. The overall goal of this proposal is to characterize the     esophageal microbiota of children with CF that are treated or untreated with acid blockade     medication and to measure its possible impact on respiratory disease to develop novel     treatment strategies.   "
39422|NCT02769624|"     In this pilot study investigators propose to explore the effects of a locally delivered     inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood     flow, venous pressure response and vascular function in stable Fontan patients. Investigators     will also assess the effects of resting and acute rises in exercise induced systemic venous     pressure on liver stiffness and will also assess whether treprostinil will attenuate the     acute stiffness increase that investigators expect to see. This will be a prospective,     randomized, double-blinded placebo controlled, crossover trial. Following recruitment and     informed consent, each participant will undergo three study visits, including baseline     testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and     visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.   "
39423|NCT02769611|"     This study evaluates the effect of ruboxistaurin for its safety, tolerability, and     effectiveness in treating adult patients with heart failure. Patients will receive 1 dose of     oral ruboxistaurin.   "
39424|NCT02769598|"     Fighting against the pain caused by the disease or by the diagnostic and therapeutic     procedures for children is a daily and essential concern of health care in the pediatric     sector. The quantification of pain is needed to effectively adjust analgesic therapy while     limiting the side effects of treatment. Nowadays many scales are validated for children, but     they are based on one-off measures and hetero assessments are often subjective and dependent     on many factors including the presence of staff to children's sides.      Recent developments in the analysis of the cardiac signal in real time under the influence of     autonomic control, have led to the development of a new painful stress quantification index.     A monitor has recently been developed and provides an index of nociception and analgesia (ANI     index). The validation of this nociception index has not been validated for pediatric care in     a sector where particular attention is given to control pain.      The main purpose of this study is to show the consistency of the index compared to a     validated pain scale and used routinely in non-sedated children hospitalized in pediatric     intensive care units. The caregiver will have the opportunity to fine tune the effective     treatment.   "
39425|NCT02769585|"     Randomized study evaluating self-hypnosis versus certified diabetes educator training for     weight loss in type 2 diabetics.   "
39426|NCT02769572|"     This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to     evaluate the efficacy of moxibustion for osteoarthritis of the knee.   "
39427|NCT02769559|"     The data gathered here will be used to evaluate the efficacy and safety of the mammary     reduction in patients with macromastia.   "
39435|NCT02769455|"     Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional     content at a glance, in order to help consumer make informed choices, has been identified as     of major interest by public health specialists of many countries. French health authorities     are currently considering the endorsement of a FOP nutrition label, but no specific format     has yet been determined. A more simplified FOP nutrition label has been put forward in     France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label     is well perceived and understood by consumers. The introduction of a FOP nutrition labelling     system has been identified as challenging in certain population groups, due to their lower     level of nutrition knowledge and unhealthier diets.      The aim of the investigators is to evaluate the impact of FOP nutrition labels on the     nutritional quality of the shopping cart in an online experimental supermarket in various     nutritionally at-risk populations. Two FOP systems will be tested to a control situation     without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and     present in a portion of food products sold in France, and the 5-Colour Nutrition Label     (5-CNL).      Three 3 arm parallel arm randomized trials are designed, each targeting a specific     population. The methodology and interventions are identical across trials. Trials will be     conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3)     Older subjects with identified chronic diseases. The intervention consists in the application     of FOP nutrition labels on all food products, either the RI label, currently in use in some     products in France, and the 5-CNL label. A control situation with no FOP will also be used.     Participants will be asked to perform a shopping session in an experimental online     supermarket, in one of the three experimental conditions described. The main outcome will be     the overall nutritional quality of the shopping cart, assessed using the mean Food Standards     Agency Nutrient profiling system score of the items in the shopping cart.   "
39436|NCT02769442|"     A randomized prospective comparison of two FDA approved intravenous catheters in the     emergency department setting. The Terumo SurFlash Plus offers novel technologies that promise     to increase intravenous access success rates and decrease blood contamination of the     insertion site. This study would analyze these properties in our busy, urban emergency     department setting where time and safety of intravenous access are most critical.   "
39438|NCT02769416|"     The NCTT is a prospective, multicenter, observational research network for subjects with     chronic spinal cord and/or chronic traumatic brain injury.   "
39439|NCT02769403|"     The purpose of this research study is to determine if using HeartMath's biofeedback with     emWave Pro daily mindfulness practice: is a practical and effective intervention to improve     job satisfaction and performance of physicians, advance practice clinicians, and nurses;     improves patient satisfaction; and affects resting blood pressure and heart rate when     comparing baseline to follow-up measures.   "
39440|NCT02769390|"     The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block     provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone      It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years     old, following eletive hypospadias surgery, under general anesthesia and caudal epidural     block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus     clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg.     The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure     will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs,     activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at     24 h will be avaiable.   "
39441|NCT02769377|"     To determine if glucometer combined with mobile-phone based data transfer system would be     useful for patient diabetes to manage their glycemic control.   "
39442|NCT02769364|"     Decision-making for treatment of metastatic breast cancer after the second line of     chemotherapy was limited by the lack of established predictive factors of benefit for further     chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall     survival improvement in the third-line setting or beyond. The purpose of this study was to     define the clinical profile of metastatic breast cancer participants achieving long-term     benefit from chemotherapy with eribulin in the third-line setting or beyond.   "
39443|NCT02769351|"     In patients with advanced volume overload, minimally invasive ultrafiltration treatment in     the acute phase can have a positive effect on clinical outcome. The aim is to collect     treatment data in the context of a prospective registry of the safety and performance of     minimally invasive ultrafiltration. The data will be recorded via an electronic case report     form (eCRF); the eCRF runs on a server located in Germany and complies with current data     protection regulations. It is intended to include about 300-500 patients with advanced volume     overload at a minimum of 10 sites. In addition, data on a disease management programme     (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The     treatment data from each patient will be recorded over 12 months. An interim analysis will be     performed after 150 patients have been observed for 6 months. The knowledge about     ultrafiltration in volume overload obtained from the registry, in some cases in combination     with a disease management programme, is intended to improve the body of evidence. In     addition, the data will be used for hypothesis generation.   "
39444|NCT02769338|"     This program will seek to implement a quality improvement program to improve the care of     Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The     investigators will evaluate the implementation and effectiveness of the quality improvement     program.   "
39445|NCT02769325|"     This is a double blinded, randomised controlled trial that will compare atropine to placebo     for postoperative pain in laparoscopic gynaecological surgery   "
39447|NCT02769299|"     The overall objective of this proposal is to determine the utility of sensitive imaging and     biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation     doses to the heart. We will focus specifically on patients receiving photon or proton chest     radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury,     as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.   "
39448|NCT02769286|"     Treatment efficacy of osimertinib will be assessed in patients with lung cancer harboring     activating epidermal growth factor receptor (EGFR) mutations (cohort 1) and those harboring     T790M (cohort 2) which were detected from circulating tumor DNA   "
39452|NCT02769234|"     In a previous study, NCT00582127, two age-matched cohorts, one clinically diagnosed with mild     Alzheimer's disease and the other healthy controls, were tested with a hand-held EEG/ERP     system to determine if the cohorts could be discriminated using the EEG/ERP measures. This     study proposes to retest the AD cohort 18-60 months after their first test to characterize     the change in EEG/ERP measures correlated with the longitudinal change in neuropsychological     testing.   "
39453|NCT02769221|"     This study compare the intubation success rate between video laryngoscope and rigid video     stylet in cervical spine surgery patients. Half of patients will receive endotracheal     intubation by video laryngscope, other half of patients will receive endotracheal intubation     by rigid video laryngoscope.   "
39454|NCT02769208|"     The purpose of this study is to evaluate whether two different central air purification     technologies reduce air pollutant exposure and beneficially influence health as evaluated     with a suite of biological markers related to cardiovascular and respiratory disease risk.   "
39455|NCT02769195|"     This study is a secondary, pooled analysis of two completed phase 3 clinical trials:      (i) GSK-HGS1006-C1056 (BLISS-76): A Phase 3, Multi-Center, Randomized, Double-Blind,     Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006,     LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus     Erythematosus (SLE); and,      (ii) GSK-HGS1006-C1057 (BLISS-52): A Phase 3, Multi-Center, Randomized, Double-Blind,     Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006,     LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus     Erythematosus (SLE)      The study will assess the discriminant validity of a proposed measure of low disease activity     (the Lupus Low Disease Activity State, LLDAS) in patients with SLE.   "
39458|NCT02769156|"     This pilot and feasibility study is focusing on patients presenting with suspected     malignancies of the lung and pleura who are considered to be good surgical candidates. The     primary end-point of the study is to determine the sensitivity of OTL uptake and expression     in identifying those lung and pleural nodules when excited by an imaging probe. There will be     a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, two to     three hours, prior to surgery.   "
39459|NCT02769143|"     Women in the postmenopausal period suffer hormonal changes that contribute to a number of     negative factors to health, such as reduced bone mineral density and loss of muscle mass,     which contribute to the increased incidence of falls and consequent risk of fractures. Among     the possibilities to alleviate these symptoms are mainly drug treatment and the systematic     practice of physical exercise. Exercise stands out for not offering adverse effects. One form     of exercise that has been recently investigated is the whole body vibration, another form of     exercise well accepted by the population is the Pilates method.      Taking into account the lack of literature on the benefits of vibration training; and also     the Pilates method on bone mineral density, muscle strength, flexibility, postural balance,     fear of falling and the quality of life of postmenopausal women, explains the importance of     this work.   "
39460|NCT02769130|"     This pilot study evaluates the safety and feasibility of losartan in pediatric patients with     pulmonary vein stenosis.      It is an open label single arm interventional study. The patient population involves     pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given     losartan for 1 year. Outcomes include measures of safety/adverse events and progression of     pulmonary vein stenosis.   "
39461|NCT02769117|"     The purpose of this study is to evaluate sequential fracture healing with radius/ulna     fractures and compare ultrasound to radiographs.   "
39462|NCT02769104|"     The investigators designed this study to investigate the effect of aromatase inhibitors (AI)     plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone     receptor-positive breast cancer.   "
39463|NCT02769091|"     The purpose of this study is to assess the effect of TEV-45478, as compared with placebo, on     liver health and liver fat content in patients with T2DM who also have Nonalcoholic     Steatohepatitis (NASH).   "
39464|NCT02769078|"     The overall objective of this proposal is to execute a real-world database analysis to     evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF)     patients in the U.S.   "
39465|NCT02769065|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of     TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally     in healthy participants and participants with mild cognitive impairment (MCI) or mild     Alzheimer disease (AD).   "
39466|NCT02769052|"     Objective: to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation     (TENS) self-applied for the treatment of pain and the impact of this therapy on biomechanics,     quality of life and sexuality of women with deep endometriosis.   "
39476|NCT02768922|"     This study aims at contributing with scientific evidence to the field of aphasia     telerehabilitation. In Norway today, there is an unmet need for language training in post     stroke aphasia and not all patients are offered language training. Early start of aphasia     rehabilitation and satisfying intensity do not seem to be standard clinical practice.     Language training by telemedicine could improve this situation, and this study seeks to     answer the question whether aphasia rehabilitation delivered by telemedicine can improve     language function in aphasia early post stroke.   "
39477|NCT02768909|"     Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in     Venezuela.   "
39478|NCT02768896|"     Voltage fluctuation as a result of brain activity will be recorded into the computer using an     EEG device.   "
40001|NCT02762032|"     This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin     microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1     of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo     (control) to take twice daily for 14 weeks.   "
39467|NCT02769039|"     Treatment resistant motor features, such as postural instability and freezing of gait are     common in people with Parkinson's disease and major contributors to morbidity and mortality.     This project will use sleep studies, quantitative motor assessments and magnetic resonance     imaging to examine the relationship between abnormally increased muscle activity during rapid     eye movement sleep and the development and progression of treatment-resistant postural     instability and gait disturbances. Specifically, the investigators will test the hypothesis     that anticipatory postural adjustments (weight and pressure shifts) during gait initiation     are significantly reduced in people with Parkinson's disease who have abnormally elevated     muscle activity during rapid eye movement (REM) sleep compared to individuals will     Parkinson's disease whose REM sleep muscle activity is normal. In addition, the investigators     will test the hypothesis that the level of RSWA at baseline is predictive of measures of     motor decline (postural stability and gait) and alterations in the structure and function of     locomotor brainstem networks. Since sleep disorders can emerge years before a diagnosis of     Parkinson's disease, establishment of a link between sleep and treatment-resistant posture     and gait disorders will help identify individuals at risk of developing these disabling motor     features of disease.   "
39468|NCT02769026|"     This multicenter study will validate a panel of serum, imaging, and clinical biomarkers to     classify patient outcome early after out-of-hospital pediatric cardiac arrest. Results are     expected to have a positive and immediate impact in advancing clinical care and outcomes for     these children. This work will provide clinicians, families, and researchers with superior     tools to assess the severity of brain injury early after resuscitation in order to know who     is at risk of brain injury and may benefit from neuroprotective interventions, to monitor     response to these interventions, to plan rehabilitation strategy, and to optimize the design     of research studies that test novel interventions to improve neurological outcome after     cardiac arrest.   "
39469|NCT02769013|"     Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in     an area of co endemicity.   "
44698|NCT02700646|"     The purpose of this study is to learn more about developmental behaviors and to examine     changes in developmental progress related to motor activities among a group of infants who     received open heart surgery within the first three months of life.   "
39470|NCT02769000|"     Evaluate safety and toxicity/adverse events associated with delivery of low dose whole brain     irradiation in patients with early Alzheimer's dementia according to the National Institute     of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and     Related Disorders Association (NINCDS-ADRDA) criteria.. As a secondary goal it will establish     whether or not the intervention with low dose whole brain irradiation stabilizes or decreases     cerebral amyloid deposits and whether these correlate with the recognized progression of     Alzheimer's dementia. The investigators will also collect information from the FDG and     Amyvid® PET Scans to determine if there is any correlation between neurocognitive/quality of     life scores and changes in amyloid plaque size, number and location.   "
39471|NCT02768987|"     Physical inactivity occurs among 65% to 95% of youth with type 1 diabetes (T1D) and based     upon limited evidence may contribute to the rapidly growing incidence of overweight among     this population. The purpose of the present study is to pilot test a 12-week intensive     lifestyle program for adolescents with overweight and T1D utilizing group exercise classes     adapted for this population, supplemented with coping skills training and diabetes     self-management education to address problem solving behaviors that limit their physical     activity and weight control. Our primary aim is to evaluate the changes in physical activity     adherence, anthropometrics, and self-management behaviors following this program among     sedentary adolescents with T1D and overweight (n=25, OW) compared with sedentary adolescents     with T1D and normal weight (n=25, NW). We hypothesize that the OW group will achieve improve     physical activity adherence and anthropometrics to the same or greater extent as the NW group     and previous Bright Bodies cohorts, and that these changes will correlate with improved     exercise-related problem solving. Our secondary aim is to evaluate changes in adipocytokines     and epigenetic factors related to the etiology of overweight/obesity following our physical     activity intervention. We hypothesize changes in these biomarkers will correlate with changes     in anthropometry variables and partially explain any differences in response between the     groups and individuals should those occur.   "
39472|NCT02768974|"     This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with     active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized     to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.   "
39473|NCT02768961|"     The objectives of this study are:        1. To perform a systematic screening and evaluation of the prevalence of infection by          hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV)          in the prison population.        2. To perform an adequate characterization of patients and the characteristics of HCV          infection in this population.        3. To evaluate the effectiveness and security in the prison population of an          interferon-free antiviral regimen.        4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of          persistent infection, reinfection and super-infection in a prison population, in the          short, medium and long term.   "
39474|NCT02768948|"     The severity of the diabetic nephropathy is proportional to proteinuria rate and degree of     renal interstitial fibrosis. Despite many treatments available today, diabetic nephropathy is     responsible for a quarter of cases of end-stage renal disease (ESRD) requiring the use of     renal replacement therapy or kidney transplantation. It develops as follows: chronic     hyperglycemia of diabetes abyss renal glomeruli that allow proteins in the urine room. In     response, the tubular epithelium produces monocyte chemoattractant protein-1 (MCP-1) that     attracts monocytes circulating in the renal interstitium. Monocytes then differentiate into     M1 or M2 macrophages. M1 macrophages increased MCP-1 production while M2 macrophages produce     transforming growth factor beta (TGF-β) pro-fibrogenic. Renal fibrosis is negatively     correlated with the glomerular filtration rate itself proportional to the number of nephrons.     The decrease in the number of nephrons majorises secondarily proteinuria by the onset of     focal segmental glomerulosclerosis lesions. Production of MCP-1 increases with the renal     proteinuria because M1 macrophages earning kidneys reinforce the production of MCP-1, and     fibrosis worsens because M2 macrophages infiltrate in turn kidneys and produce TGF -β.      A way of limiting renal fibrosis would be to decrease renal monocytic infiltration by     promoting the differentiation of monocytes towards macrophages M2. Although more numerous, M2     macrophages no longer benefit the kidneys because the decline of M1 macrophages decrease     renal MCP-1 production. Ex vivo IL1-β orients the differentiation of monocytes towards     macrophages M1 and IL-4 to M2. By cons in vivo, the differentiating factors are poorly known.     It is remarkable that metformin and telmisartan increase M2 macrophages M1 macrophages and     decrease, respectively, in humans and mice. Moreover, telmisartan reduces proteinuria more     than losartan in diabetic nephropathy in humans and Metformin decreases the amount of TGF-β     intra-renal mice. This effect of telmisartan is independent of the type 1 receptor of     angiotensin II (AT1R) since it is not obtained with losartan.      Telmisartan is a partial agonist of peroxisome proliferator-activated receptor gamma     (PPARgamma), the working assumption is that telmisartan fosters the transition of monocytes     to macrophages M2 form, and limit the recruitment of more monocytes in the kidneys and     therefore proteinuria and renal fibrosis. To show this, it will be compared the ability of     monocytes to differentiate ex vivo in M1 or M2 macrophages in diabetic nephropathy patients     treated with losartan or telmisartan then it will characterize the role of PPARgamma in the     monocyte / macrophage transition. Finally, it will be compared the urinary excretion of amino     terminal propeptide of procollagen type 3 (PIIINP), considered a marker of renal fibrosis in     patients receiving losartan or telmisartan.   "
39479|NCT02768883|"     The immediate goal of the Imperial County CER Asthma project is to identify strategies to     improve asthma control among children 0-17 years old and the asthma control behaviors of     their families, their health care providers, and the communities in which they live. Our     long-term goal is to improve the quality of life of children with asthma and potentially     reduce families' economic and social burdens of uncontrolled asthma   "
39480|NCT02768857|"     This study evaluated the effects of an integrated program of touch-observation and task-based     mirror therapy on sensorimotor function in nerve injury patients. Before the return of     protective sense (Value of Semmes-Weinstein monofilament test > 4.31), half of the     participants received 15 minutes of mirror therapy program, followed by 20 minutes of regular     hand therapy and 20 minutes of physiotherapy.While the other half received 15 minutes     protective sensory reeducation programs, 20 minutes of regular hand therapy and 20 minutes of     physiotherapy in each treatment session. Once the patients had regained the protective sense     (Value of Semmes-Weinstein monofilament test < 4.31), the discriminative sensory reeducation     program was started for the participants in both groups. The hypothesis was that using the     mirror therapy for sensorimotor reeducation in the early phase after nerve repair would yield     better results with regard to the returning of sensation, sensorimotor control ability and     hand function than using a classical reeducation program alone.   "
39481|NCT02768844|"     The overall purpose of this project is to to quantify the physiology of neonatal drug     withdrawal and develop non-pharmacological techniques to help improve the therapeutic     management of Neonatal Abstinence Syndrome (NAS).   "
39522|NCT02768311|"     Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems     as well as a few studies on the prevalence of pain after root canal treatment by rotary     systems, And in particular, comparing the amount of pain after treatment, between systems     RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of     applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after     endodontic treatments.   "
39482|NCT02768831|"     In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in     pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion     while an inadequate seal may impact ventilation and potentially increase the risk of     aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective     tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible     leak and measuring the difference between the inspired and expired tidal volumes (TV). This     is a prospective study to compare these two methods used to create a tracheal seal and     measure the intracuff pressure after a satisfactory tracheal seal is established.   "
39483|NCT02768818|"     The investigators aimed at evaluating the effectiveness of probiotics ingestion in changing     maternal microbiota and preventing gestational diabetes in overweight and obese women.      To achieve these goals, obese (BMI> 30 kg/m^2) or overweight (BMI> 25 kg/m^2) pregnant women     with risk factors were enrolled in the study and randomized to the supplementation with the     probiotic VIVOMIXX® or with placebo.      The endpoints of this study are to evaluate if the dietary supplementation with the probiotic     VIVOMIXX® modifies the maternal fecal microbiota (bifidobacteria and lactobacilli) and     related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase), and if this     if this is linked to an improvement of the intermediate metabolism (positive Oral Glucose     Tolerance Test at 24-26 weeks).   "
39484|NCT02768805|"     This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the     immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The     study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent     VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure     criteria. The study will also help to define the optimal dose, establish potential     competitive advantages, and support the design of future studies.   "
39485|NCT02768792|"     Rationale:The purpose of this research study is to test the effectiveness of the standard     high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab     on day 14 as induction therapy in patients with relapsed and refractory acute myeloid     leukemia (AML). Patients who achieve a response to treatment will continue on the study drug     (pembrolizumab) every 3 weeks for up to 1 year maintenance therapy.      Purpose:This is a study about a new investigative drug, pembrolizumab (MK-3475) that is being     studied in a clinical research trial together with standard chemotherapy (HiDAC) in relapsed     and refractory AML. The study will also explore the association between potential immune     biomarkers and clinical outcomes with pembrolizumab; therefore all patients will have blood     and bone marrow samples collected before and after treatment to determine the dynamic nature     of immune signatures pre and post-treatment.   "
39486|NCT02768779|"     Hair samples from subjects on antiretroviral therapy, both HIV- and HIV+ patients with HIV     RNA <50copies/mL for >6 months will be analyzed to investigate the influence of race, hair     color and hair treatment on ARV response.   "
39487|NCT02768766|"     The purpose of this study is to find out what effects, good and/or bad, intermittent dosing     of the drug Selumetinib will have on subjects with uveal melanoma. Selumetinib is a drug that     blocks (or turns off) methyl ethyl ketone (MEK), a protein activated in some uveal melanoma     cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop the cancer from growing.   "
39488|NCT02768753|"     The purpose of this study is to compare the therapeutic effects between the axillary     bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic     thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the two     approaches.   "
39489|NCT02768740|"     We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult     medical intensive care units. Patients presenting septic shock were rapidly administered one     of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during     seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300     mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of     treatment.   "
39490|NCT02768727|"     The dual objectives of this study are to determine if the phenomenon of neural inertia is     present in humans and to determine whether the order of neurocognitive function is invariant     among anesthetic agents. This study will enroll 12 healthy volunteers, ages 20-40 years, who     will receive xenon gas (concentrations ranging from 0% to 75%) delivered via inhaled route     through the ENHANCER 3000.   "
39491|NCT02768714|"     This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least     180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised     (1:1) to receive either Eurofarma's pegfilgrastim (n = 90) or Neulastim (n = 90) in 8 to 10     sites in Brazil. Subjects will undergo a maximum of 4 cycles of myelosuppressive chemotherapy     (21 days per cycle).   "
39493|NCT02768688|"     This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5     healthy human subjects as visualized by diffusion tensor MRI. The study is designed to     measure clinically established, safe imaging of DTI and cerebral blood flow at baseline,     during a continuous intravenous infusion of dexmedetomidine at doses designed to produce     anesthesia-induced unconsciousness to simulate natural sleep, and again on return to     wakefulness.   "
39494|NCT02768675|"     The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility     assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal     kyphotic corrective constructs.   "
39495|NCT02768662|"     This is an open-label extension study of a single intratympanic injection of OTO-104 given     every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study     104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of     OTO-104) in order to be eligible for this open-label extension study.   "
39496|NCT02768649|"     The purpose of this study was to assess the safety and tolerability of injections of RBP-7000     in subjects with stable schizophrenia   "
39497|NCT02768636|"     Heart rate variability can represent physiological and psychological levels via sympathetic     and parasympathetic variables on autonomic nervous function. Omega-3 has shown that it can     effect on physiological and psychological with many good results. The pathways to explain     about its effect had been studied in many contexts. Effect to autonomic nervous function by     Omega-3 is our interesting question.   "
39498|NCT02768623|"     Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4     million Canadians and over 300 million people worldwide. Unlike most other chronic diseases,     asthma affects a significant proportion of children - an estimated 21% in Ontario. Asthma is     also the leading cause of hospitalization for children in Canada and is a significant cause     of school and work absenteeism. Though asthma is generally considered a chronic disease, it     can be fatal in some instances - in 2009, an estimated 91 Ontarians died of this condition.     Effective management of asthma can prevent exacerbation and more severe negative health     consequences. In fact, estimates show that over 80% of the asthma-related deaths could be     prevented through proper education. However, evidence also shows that over 55% of patients     with moderate to severe asthma do not have their asthma symptoms under control, despite     regular doctor visits. Less than a third (31%) of asthma patients report receiving an asthma     action plan from their physicians, although such plans are associated with fewer ER visits,     lower hospitalization rates and improved lung function. Hence, there is a clear opportunity     to improve the management of asthma and reduce the incidence of related complications.      Given the scientific evidence of pharmacists effect on asthma management there is a strong     rationale for introducing an asthma-specific pharmacist-led intervention for Ontarians     suffering from this chronic disease. However, the implementation of such a program should be     preceded by a pilot test to ensure that the program parameters are optimized to drive     improved patient outcomes and maximum quality of service. The primary goals of this research     project are to examine the impact of a pharmacist led asthma management intervention on     patient health outcomes and to determine the optimum program structure to ensure quality of     service delivery.      This study employs a mixed-methods study design. Investigators will begin with a cluster     randomized controlled trial and end with exit interviews.This study will consist of a     prospective, randomized controlled trial conducted in the community setting. A total of 12     pharmacies across the Greater Toronto Region will be recruited for this study. Each of these     pharmacies will be randomly assigned in a 1:1 ratio to either the intervention group or the     control group. All data will be analyzed using statistical software. Significance level will     be set at 0.05. Pharmacy level descriptive characteristics, including mean and standard     deviation for the number of patients will be reported. There is a low perceived risk for this     study; however, the investigators will take every precaution to ensure this study is     conducted in an ethical manner, including protecting patient confidentiality and anonymity.   "
39499|NCT02768610|"     Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and     analgesic properties. This study was designed to evaluate the inhibitory effects of     preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal     intubation in elderly patients being treated for hypertension.      Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of     Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly and     assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg     dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood     pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate     (HR) were recorded preoperatively at ward, immediately after study drug administration, and     at 1, 3, and 5 minutes after endotracheal intubation.   "
39500|NCT02768597|"     The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker     ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere     with either a +2 mm or a +6 mm offset.   "
39501|NCT02768584|"     Clarify the determinants of the construction of a Therapeutic Alliance (AT) between     paramedical staff (nurses and caregivers ) and adult patients in a functional unit of     full-time general psychiatric Whether the quality of Therapeutic Alliance influences the     continued support outpatient , after completion of full-time hospitalization.   "
39502|NCT02768571|"     This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized,     double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute     stroke patients with severe motor involvement. Primary objective is to demonstrate the     efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio     of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of     FMA at baseline) in patients with subacute stroke. Secondary objectives are to evaluate the     safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with     severe motor involvement randomized to administration of Cerebrolysin combined with     rehabilitation for 3 weeks show better outcome on global function (Korean version Modified     Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS),     cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal     Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and     block test, B&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion     tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.   "
39503|NCT02768558|"     Patients with Stage III unresectable non-small cell lung cancer will receive thoracic     radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2 weeks for a     year.   "
39557|NCT02767856|"     This study is designed to answer the question: What if the Intermittent Occlusion     (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment     only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks?      Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and     randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2)     Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.   "
39504|NCT02768545|"     NPC1L1 is a key transporter in the enterohepatic cycle of cholesterol. Initial in vitro and     in vivo data show that blocking this receptor with ezetimibe results in delaying infection in     these models. The investigators hypothesize that HCV has an enterohepatic cycle, being     secreted in bile and reabsorbed either in the canalicular membrane or in the intestine by     association with NPC1L1, following a path similar to the cycle of cholesterol in humans. To     prove this hypothesis the investigators propose to assess the effect of ezetimibe treatment     in HCV infected individuals undergoing liver transplantation to avoid or delay HCV infection.     For this purpose, the investigators propose to administrate ezetimibe 10 mg/d for 12 weeks to     12 patients with chronic hepatitis C infection listed for a liver transplantation.   "
39505|NCT02768532|"     Vedolizumab (VDZ) is a monoclonal antibody which has shown its efficacy in Crohn's disease by     inducing and maintaining clinical response/remission. The French marketing authorization was     obtained for Crohn's disease in patients in failure with anti-TNF (Tumor Necrosis Factor)     agents.      For Crohn's disease patients treated with vedolizumab, a strong association between     vedolizumab serum levels and clinical response to induction and maintenance was demonstrated     by anterior studies.      It could be of paramount interest to early identify Crohn's Disease patients under     vedolizumab who will be responders to vedolizumab induction and to identify those who will     achieve clinical remission under maintenance therapy with vedolizumab.      Researchers decided to assess the clinical response to vedolizumab induction at week 10. For     clinically non-responders at week 10, an additional dose of 300 mg of vedolizumab will be     infused at week 10 and then every four weeks.   "
39506|NCT02768519|"     The purpose of this study is to determine the indicative bioavailability of a single oral     dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after     oral dosing.      Eleven male and female healthy participants aged 45 years and over will be entered into this     phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to     evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of     OTS167 when administered by the oral route. Correlative studies include evaluation of safety     endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate the     safety and tolerability of oral dosing from lower dose.   "
39507|NCT02768506|"     Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a     variable limb length between 250 cm and 300 cm or gastric bypass.      Results on weight loss, comorbidities resolution, complications, re-operations, need of     supplements are registered.   "
39508|NCT02768493|"     The recent study revealed that high-volume caudal block caused reduction in cerebral blood     flow velocity and cerebral oxygenation. It was supposed to be associated with increased     intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of     diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to     evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing     urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before     urologic surgery will be divided into high dose group (n=40) and low dose group (n=40).     Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine     for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15%     ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after     caudal block measured by optic nerve ultrasonography.   "
39509|NCT02768480|"     The study is a randomized clinical trial, controlled, open label that aimed to compare two     groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by     primary care (control group) and patients followed by primary care and supported by phone     calls (intervention group).   "
39510|NCT02768467|"     Prior studies have been performed to understand the optimal way to minimize the morbidity     rate of buccal mucosa. While some studies have reported primary closure to be inferior to     healing by secondary intention, this appears to be true for large defects greater than 2 cm     in width. For small defects for which the wound can be closed without tension, the most     recent study has shown improved pain outcomes in the immediate post-operative setting,     although no difference is seen long term whether or not the wound was primarily closed.     However, for larger defects, standard practice is to allow delayed healing by secondary     intention.      The use of Alloderm graft placement for donor site coverage was first described in Armenakas'     group. Alloderm is an acellular dermal lattice from human allograft skin. The only study to     report the use of Alloderm failed to find a significant improvement in patient outcomes;     however, very small defects were included in this study and the control group underwent     primary closure, which has been shown to be inferior for large defects. Importantly, no     increase in post-operative pain was noted, although there was some increased swelling     reported. From experience, patients with moderate and large (>2 cm width) defects following     buccal mucosa harvest benefit from Alloderm placement with decreased post-operative pain,     more rapid resumption of normal diet and mouth function with no associated increase in     morbidity of the procedure. This study aims to determine whether this is a reliable     improvement in technique.      This study will clarify how the cheek heals after the buccal mucosa is removed during     reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix     or no stitches after the surgery. Subjects will be evaluated up to six months to determine if     the outcomes of the tissue matrix graft are better for the subject.   "
39511|NCT02768454|"     To study the outcome of antibiotics stewardship   "
39512|NCT02768441|"     The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release     dexamphetamine will be studied. These individuals have received this medication before in a     previous trial where the pharmacodynamics were investigated. This trial will last 5     consecutive days during which blood samples will be drawn for pharmacokinetics analyses.     Dried blood spots will also be collected for the clinical validation of the bioanalytical     method wherein these are used.   "
39513|NCT02768428|"     Objective: To compare the effectiveness between Video and Handbook on providing knowledge of     TACE.      Study Design: A prospective, randomized, controlled trial.   "
39514|NCT02768415|"     The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral     vinorelbine can shrink or slow the growth of pretreated HER2 negative metastatic breast     cancer.   "
39515|NCT02768402|"     The purpose of this study is to assess the safety and performance of the Caisson     Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of     severe symptomatic MitralValve Regurgitation (MR).   "
39516|NCT02768389|"     Patients may participate in this research study if they have glioblastoma. (a brain tumor)     that has come back after being treated. Standard treatment for this cancer is a chemotherapy     drug called bevacizumab. This research study involves bevacizumab in combination with a     special diet called the Modified Atkins Diet (MAD).      The purpose of this study is to research if patients can stay on the MAD when it is added to     the standard bevacizumab treatment.   "
39519|NCT02768350|"     The purpose of this study include (1) To investigate the efficacy of ventilator     hyperinflation technique to re-expand lung atelectasis on patients with critical trauma who     intubated and mechanical ventilation in the intensive care unit, (2) To investigate the     effectiveness of ventilator hyperinflation technique to improve airway clearance on patients     with critical trauma in the intensive care unit, and (3) To explore the acute responses of     ventilatory functions to ventilator hyperinflation technique on patients with critical trauma     who intubated and mechanical ventilation in the intensive care unit.   "
39520|NCT02768337|"     Proof of principle phase 1b / randomised phase 2 study of afatinib penetration into cerebral     metastases for patients undergoing neurosurgical resection, both with and without prior     low-dose, targeted radiotherapy.   "
39521|NCT02768324|"     Sepsis is a life-threatening condition that arises when the body's response to infection     injures its own tissues and organs. Common signs and symptoms include fever, increased heart     rate, increased breathing rate, and confusion. Clinically, sepsis patients with diarrhea     often result in a bad prognosis. Gut microbiota consists of a complex community of     microorganisms that live in the digestive tracts of animals. The gut microbiota comprises the     largest and most diverse reservoir of mutualistic microorganisms associated with animals. The     aims of this study is to determin the effect of gut microbiota on the prognosis of Sepsis, by     using 16s pyrosequencing, comparing the blood culture result.   "
39523|NCT02768298|"     The purpose of the study is to determine the effect of LCZ696 vs. Enalapril on improvement of     excercise capacity in patients with chronic heart failure with reduced ejection fraction   "
39525|NCT02768272|"     The investigators have design a randomized double blind clinical trial to know the incidence     of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical     dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses     versus patient controlled epidural analgesia. The role of the epidural technique (epidural     versus combined spinal-epidural) in the incidence of BP will be also evaluated.   "
39526|NCT02768259|"     -  Measuring the incidence and prevalence of PAH in Egyptian patients with different types          of MCD        -  Determination of survival & the risk factors of mortality.   "
39527|NCT02768246|"     Ventilation of a bearded patient with the commonly used face mask has low efficiency because     of difficulties to achieve a tight seal around the mouth and nose.      The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor     (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the     need for a face mask.   "
39528|NCT02768233|"     The aim of this study is to evaluate the influence of personality profiles in patients with     MOH and to evaluate the effect of a custom-made educational programme as an add-on to     standard treatment as compared to standard treatment alone in MOH patients using a randomized     controlled trial (RCT) design.   "
39529|NCT02768220|"     Single-center open-label multiple dose randomized two period cross-over study to examine     Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin     administration.   "
39530|NCT02768207|"     This is a single arm, multicenter, open label, and non-randomized clinical study on adult     participants with unresectable or metastatic melanoma. The study will be conducted in two     phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis     triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical     outcome for the participants treated with vemurafenib plus cobimetinib. The length of the     study will be approximately 38 months.   "
39531|NCT02768194|"     This will be a single centre, single blind, randomized, three treatment, three period     crossover design, modified, in situ, study in healthy participants. In this in situ model the     tubule occlusion properties of dentifrices will be evaluated by comparing an experimental     dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral     water) over a ten day period.   "
39555|NCT02767882|"     The primary aims of total knee replacement are improvement in functional activities and     reduce pain due to degenerated knee joints. However, there are around 20-30% of patients     would develop significant pain problem despite uncomplicated total knee replacement. It     accounts for major post-operative problems and burdens.      Dexamethasone is glucocorticoid which is associated with anti-inflammatory response. It is     well known to have prophylaxis effect for post-operative nausea and vomiting. Perioperative     single dose of systemic dexamethasone have shown to be useful for reduction in pain and     cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that     dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after     surgical procedures. However, this dose recommendation is not surgery specific. It is     essential to have more RCTs evaluating the optimal dose of steroid for pain management after     hip and knee surgery.   "
39532|NCT02768181|"     Background:        1. Burden: The prevalence of stunting among the under-five children in Bangladesh was >55%          in 1997, which reduced to 41.9% in 2011. This reduction took 14 years to achieve with          existing interventions, and till today Bangladesh remains among the countries with the          highest stunting prevalence.        2. Knowledge gap: In the Lancet series on Maternal and Child Nutrition, Bhutta et al (2013)          modelled the effect of 10 direct interventions on lives saved and economic costs in 34          countries which contains 90% of the children with stunted growth. Their findings          suggested that at 90% coverage, these interventions could cut down under-5 year          mortality by 15% and avert one-fifth of stunting. The total additional annual cost was          estimated at $9.6 billion. There is a dearth of primary research, however, to determine          a feasible, effective bundle of interventions for developing countries.        3. Relevance: This study will review and test different sets of nutrition-specific          intervention bundles in a cohort of pregnant women and the subsequent impact on the          length-for-age Z score (LAZ) of their offspring from that pregnancy.      Hypothesis: Five selected nutrition-specific interventions implemented during early pregnancy     and during first two years of child's life in different bundles will cause a shift of 0.4 in     mean HAZ score among children at 24 months of age compared to those in comparison arm.      Methods: The investigators propose a community-based randomized trial (CRCT) to evaluate the     effectiveness of different combinations of the five selected nutrition-specific interventions     and identify the best combination for improving childhood HAZ. Selected interventions include     prenatal nutrition supplementation; intensive counselling on prenatal nutrition, exclusive     breastfeeding and timely complementary feeding; and complementary food supplementation during     6-23 months. The proposed study area is Habiganj district, Sylhet division. 125 clusters     (each ~2000 population or ~450 households) will be selected from 12 homogenous unions in 2     adjacent sub-districts. The clusters will then be randomly assigned to any one of the 5 study     arms. Data would be collected at baseline and followed up, including on nutritional intake     and anthropometric measurements of mothers and offspring. Primary outcome measure/variable     would be mean HAZ of offspring at 24 months. Secondary outcome variables include nutritional     intake during pregnancy, maternal weight gain, exclusive breast feeding up-to 6 months, and     birth weight.      Implications: The investigators expect that the results will serve to inform and shape future     health policy decisions related to promotion of maternal and child health.   "
39533|NCT02768168|"     The purpose of this study is to investigate the efficacy of dezocine pretreatment on     dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).   "
39534|NCT02768155|"     A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of     subjects with osteoarthritic (OA) knee pain   "
39535|NCT02768142|"     Throughout the history, the neonate was dependent on maternal touch and care for survival. In     modern obstetrics, with hospital care the neonates are seldom separated from their mothers     after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk     production, lactation and improve maternal and neonatal outcome.      Oxytocin is the primary hormone responsible for uterine contraction and prevention of     postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.      The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was     found to decrease postpartum milk production, postpones early lactation and decreases     exclusive breastfeeding.      During the typical CD, the neonate is usually presented for a short while to the mother and     breastfeeding is usually delayed at least a number of hours until after the surgery and the     recovery period.      Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to     start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin     secretion increases with ESTS and during breastfeeding.      The aim of this study is to examine blood loss that occurs after Natural CD compared to     standard CD without an ESTS contact.   "
44723|NCT02700321|"     The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more     efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal     intubation after crash induction in non severely hypoxemic patients   "
39536|NCT02768129|"     The goal of this study is to investigate the role of central neural pathways in mediating     chronic pain. The aim of the study is to test the effect of stimulating brain regions that     are part of a network underlying central pain processing using a non-invasive brain     stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have     used tDCS to target both sensory related cortical areas and those important for higher-order     representations of pain. This study will target brain regions important for the behavioral     response to the chronic sensation of pain. The hypothesis is that stimulation of these brain     regions can modulate not only the affective component of pain, but ultimately also improve     functioning and quality of life. This hypothesis will be tested by treating study     participants eighteen and older with chronic low back pain (CLBP) of greater than six months     using tDCS. To be part of this study, participants must meet all the inclusion and exclusion     criteria.   "
39537|NCT02768116|"     A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active     Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary     Bifurcation Lesions.   "
39538|NCT02768103|"     The number of people in the United States who have survived SCI is estimated to be     approximately 273,000 persons. Around 50% of the injuries are to the cervical spine resulting     in tetraplegia. An important rehabilitation goal in this population is recovery of upper limb     function, which could decrease medical costs and improve their quality of life.     Re-establishing active grasp and pinch strength to the hand can be accomplished by surgeries     that transfer the tendon of a strong muscle to restore strength to a paralyzed muscle, but     the outcomes of the surgeries are variable. The investigators have demonstrated in an ongoing     study, the functional gains after surgery can be improved with a focused therapy program to     retrain the transferred muscle. The propose of this study is to examine the cortical     mechanisms that drive successful muscle re-education after surgery. Understanding the neural     (brain) activity associated with functional performance can help to predict who will respond     to therapy and will guide evidence-based rehabilitation programs to improve upper limb     function in tetraplegia.   "
39539|NCT02768090|"     This study will investigate a new diagnostic technology in order to expand current     understanding of inflammatory and neoplastic cutaneous disease processes such as eczema,     psoriasis, granuloma annulare, cutaneous lymphoma, squamous cell carcinoma, basal cell     carcinoma and melanoma. Protein fragments found in sweat will be collected using a diagnostic     skin patch and analyzed with mass spectrometry. The goal of this study is to identify     specific protein fragment biomarkers that may further current understanding of cutaneous     diseases. The protein expression patterns derived from sweat will be compared to conventional     histopathologic, immunohistochemical, flow cytometry, in-situ hybridization, polymerase chain     reaction, and mass spectrometry analyses of cutaneous biopsy specimens. The insight gained     from this research will be used to promote advances in disease prevention and early     diagnosis, identify prognostic indicators and new therapeutic targets.   "
39540|NCT02768077|"     This clinical study is a double-blind, randomized, placebo-controlled trial to investigate     the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients,     symptoms which have a significant impact on the quality of life of these patients.   "
39558|NCT02767843|"     This pilot study will examine the efficacy and safety of continuous negative external     pressure (cNEP) for the treatment of chronic snoring in people without obstructive sleep     apnea.   "
39541|NCT02768064|"     During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted.     The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).      All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion     of a standard temporary electrode through the femoral vein. The temporary PMK is associated     with a small but significant rate of complications.      The PMK is usually removed immediately at the end of the TAVI procedure, only when using the     Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications,     and thus the PMK is later removed in these cases.      PMK Complications seen include:        -  Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in          some cases with Tamponade        -  Infection        -  Electrode dislocation causing In-effective pacing (and/or sensing)        -  Prolonged bed rest        -  Prolonged hospitalization        -  Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of          patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was          associated with the temporary PMK.   "
39542|NCT02768051|"     Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time     in humans, in subjects undergoing ablation for the treatment of atrial flutter.      Prospective, single-center, non-randomized, open label, single arm study. Ten consented     subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will     undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure)     and post procedure follow up. All subjects will have a follow up visit within 24 hours post     procedure.   "
39543|NCT02768038|"     The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic     inflammatory bowel diseases (IBD)   "
39544|NCT02768025|"     Background: As smoking regulatory policies, including the WHO FCTC (Framework Convention on     Tobacco Control), are enforcing, demand for smoking cessation treatment is being increased.      According the trend, development and evaluation of the medical guideline, Induced     participation of medical personnel and available in Korean medical clinic, is needed.     Purpose: To evaluate the satisfaction and effect of traditional & complementary medicine     (T&CM) tobacco control program Methods: Recruited subjects were divided into control and test     groups. They treated two times a week during the first three weeks and once a week during the     last week.      Program participation rates and drop rates, satisfaction, amount of smoking before and after     programs      , smoking-related key variables, nicotine dependence test (Fagerstrom test), Expired CO     amounts, urinary cotinine amount, withdrawal symptoms, the change in quality of life(EQ-5D)     are measured.   "
39621|NCT02767024|"     Single center, prospective, randomized, non-blinded research study comparing intravenous     vasodilator infusion vs. inotropic infusion in patients admitted to the hospital or in the     emergency room at Montefiore Medical Center presenting with the diagnosis of acute     decompensated systolic heart failure with low cardiac output but no hypotensive.   "
39545|NCT02768012|"     Antidepressant-induced sexual dysfunction (AISD) affects the majority of women taking     antidepressants and reduces medication compliance: however there is a paucity of     evidence-based strategies for the management of this condition. Mindfulness-based cognitive     therapy (MBCT) has been shown to be effective in the treatment of non-antidepressant-induced     sexual dysfunction and may be beneficial in the treatment of AISD. The investigators propose     a randomized, controlled, proof-of-principle trial to establish preliminary evidence of     efficacy of MBCT in AISD and to inform the design of a larger trial to evaluate its     effectiveness   "
39546|NCT02767999|"     Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients   "
39547|NCT02767986|"     Background:      Culture can affect the way a person thinks about illness. This can affect how they seek help     for illness. It can also affect how they choose a treatment and follow it. This can lead to     health disparities among certain groups of people. Breast and colon cancers are the most     common cancers for Latinos. Even though they get these cancers at lower rates than other     population groups, Latinos are more likely to be diagnosed with these cancers at advanced     stages. Researchers want to study what Latina women immigrants believe causes breast and     colon cancer and other factors they think play a role in disease. This understanding could     lead to better interactions between Latinos and their doctors.      Objective:      To learn more about what Latina immigrants believe causes breast and colon cancer and other     factors they think play a role in disease.      Eligibility:      Women ages 18 and older who:      Were born in Latin America      Speak Spanish      Have never had breast, ovarian, or colon cancer      Design:      Participants will be interviewed in person or over the phone. This will take up to an hour.     The interview will be recorded. Participants will answer questions about:      Their family s cancer history      What they think causes breast and colon cancer      What they think plays a role in disease   "
39548|NCT02767973|"     Purpose: This screening protocol is designed to assess PMN (neutrophil) responsiveness to     wood smoke particles (WSP) and the effect of the GSTM1 null genotype on this response. The     researches will identify persons responsive and resistant to the inflammatory effect of WSP.     It is anticipated that the GSTM1 genotype will be a risk factor for increased response to     WSP.   "
39549|NCT02767960|"     This study valuates the serum Tenascin-C concentration in patients with acute coronary     syndrome.   "
39550|NCT02767947|"     A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study   "
39551|NCT02767934|"     This phase II clinical trial studies how well pembrolizumab works in treating small amounts     of cancer cells that remain after attempts to remove the cancer has been made in patients     with acute lymphoblastic leukemia. Monoclonal antibodies, such as pembrolizumab, may     strengthen the immune system and help it to target remaining cancer cells.   "
39552|NCT02767921|"     This pilot clinical trial studies the side effects of recombinant EphB4-HSA fusion protein     before surgery in treating patients with transitional cell carcinoma of the bladder, prostate     cancer, or kidney cancer. Recombinant EphB4-HSA fusion protein may block an enzyme needed for     tumor cells to multiply and may also prevent the growth of new blood vessels that bring     nutrients to the tumor. Giving recombinant EphB4-HSA fusion protein before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed.   "
39553|NCT02767908|"     The present study is proposed to build on the investigators demonstration of the     effectiveness of default delivery of smoking interventions in hospital inpatients by testing     a multi-component intervention to prevent relapse to smoking after hospital discharge. The     proposed intervention is designed to integrate easily with existing services, and hence be     widely implemented if shown to be effective   "
39554|NCT02767895|"     Patients undergoing elective revascularization of their peripheral artery disease will be     randomized to a prehabilitation program or usual care prior to their scheduled procedure.   "
39559|NCT02767830|"     A 12 month long program focused on making good food choices and exercise directed at 8-12     year olds and their caregivers. The program will consist of monthly educational meetings each     teaching a new nutritional and exercise concept. Children will be given weekly exercise     schedules and their adherence to the program will be assessed. The study will culminate with     an annual children's race in May.   "
39560|NCT02767817|"     The purpose of this study is to assess the safety and efficacy of injectable collagen     scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain     injury.   "
39561|NCT02767804|"     The primary purpose of this study is to evaluate the efficacy and safety of X-396     (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that     have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.   "
39562|NCT02767791|"     The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years     and became less frequent. CINV include early (occurring within 24 hours of chemotherapy     administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.      Preventive treatment, such as Glucocorticoids, 5-HT3 receptor antagonists and NK1 receptor     antagonists, are administered according to the classification in 4 grades of expected CINV        -  Very low: <10% occurrence of CINV;        -  Low: 10 to 30% occurrence of CINV;        -  Average: 30 to 90% occurrence of CINV;        -  High: > 90% occurrence of CINV. These treatments have been the subject of          recommendations. Despite these available treatments, some patients still complain of          vomiting, or more frequently nausea and loss of appetite.      Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as     complementary treatment, mainly in the acute phase and to a lesser extent in the delayed     phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture     needles, electro-acupuncture or acupressure.      Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and     postoperative nausea, but, to our knowledge, there are no studies published on the effect of     auriculotherapy on CINV.      These complementary treatments have virtually no side effects. In our institution, a simple     treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular     point treated) is regularly use in patients who present CINV despite preventive treatment and     most of them are relieved.      The investigators propose a clinical trial in this population to assess symptoms improvement     in patients presenting CINV after their first administration of chemotherapy despite adapted     preventive treatment. Experimental treatment with semi-permanent needles takes place during     administration of the second session of chemotherapy. CINV are evaluated through the MAT     score (Multinational Association of Supportive Care in Cancer Antiemesis Tool.     Http://www.mascc.org/) that measures the frequency and intensity of nausea and vomiting in     the 24 hours following the session and during the 4 days after administration Chemotherapy.   "
39630|NCT02766894|"     Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate,     deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch     statistical analysis for underlying factors are done.   "
39631|NCT02766881|"     To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in     women with low to moderate risk DCIS who have had breast conserving surgery   "
39563|NCT02767778|"     The main purpose of this multicentric, prospective, randomized, placebo-controlled,     double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe     tool to promote recovery in acute ischemic stroke patients.      124 patients with acute ischemic stroke will be recruited and randomly assigned to real or     sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min     daily, for 5 consecutive days, starting within 48 hours from the onset of stroke.      The primary outcome will consist of reduction of the expected infarct growth at MR measured     in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness,     safety and tolerability of pulsed ELF-MF in acute ischemic stroke.   "
39564|NCT02767765|"     This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular     (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and     histologically or cytologically confirmed cancer.   "
39565|NCT02767752|"     This is a single center, randomized, double-blind, placebo-controlled phase II trial that     will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as     adjuvant treatment for 6 months in patients with surgically resected pancreatic     adenocarcinoma.   "
39566|NCT02767739|"     Community intervention trial, randomized, to promote regular PA and social and cultural     support activities for 9 months in older-adult primary care users and assess their effects on     cardiovascular risk factors and health-related quality of life.   "
39567|NCT02767726|"     Cervix cancer is a major global health concern. A way to screen and immediately treat     precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized     difference imaging and conventional imaging are used to identify suspicious lesions. We aim     to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have     3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to     colposcopy impression versus MobileOCT.   "
39568|NCT02767713|"     Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac     surgery. This prospective study was conducted to investigate the mechanisms of development of     POCD following cardiac surgery taking into account surgical technique (with use or no use of     extracorporeal circulation). The investigators focused on the role of inflammatory and stress     response to surgical procedure as potential factors involved in the pathogenesis of cognitive     dysfunction. Systematic inflammatory response in patients undergoing on-pump or off-pump     surgery was analyzed by measuring serum levels of C reactive protein (CRP) and occurrence of     systemic inflammatory response syndrome (SIRS). Stress response to surgery was evaluated     following cortisol levels and its daily variations. The degree of cognitive dysfunction was     assessed based on serum levels of S100β. The effect of dexamethasone on the levels of stress     and inflammatory response biomarkers, serum levels of S100β, as well as on the development of     POCD was compared with control group that received normal saline.   "
39569|NCT02767700|"     The tumor tissue of patients with pancreatic cancer will be submitted to next-generation     sequencing (NGS) and these data will be evaluated with an oncology treatment decision support     (TDS) software tool that is a medicinal product class 1 (CE-marked). This software will make     evidence-based suggestions for drugs likely to be effective, ineffective, or toxic (FDA     approved biomarkers). For patients fit for second-line therapy, the resulting recommendations     will be judged by the tumor board.   "
39570|NCT02767687|"     This study evaluates whether noninvasive ventilation with continuous positive airway pressure     affects tissue perfusion in patients after cardiac surgery.   "
39571|NCT02767674|"     The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP     as first-line treatment of elderly patients with Diffuse large B cell lymphoma   "
39572|NCT02767661|"     The study is designed to compare the clinical benefit following treatment with aromatase     inhibitor in combination with metronomic capecitabine versus aromatase inhibitor alone in     women with hormone receptor-positive, Her2-negative advanced breast cancer who have not     received prior systemic anti-cancer therapies for their advanced/metastatic disease.   "
39573|NCT02767648|"     The goal of the study is to characterize the epidemiologic data of the neonatal and infant     cholestasis.   "
39574|NCT02767635|"     The aim of the study is to compare two different injection sites of low dose botulinum toxin     type A with steroid in treating lateral epicondylalgia.   "
39575|NCT02767622|"     This study included 20 patients listed for liver transplantation in addition to 20 age- and     sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations     were performed for both patients and controls before and 6 months after liver     transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B,     Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver     transplantation.   "
39576|NCT02767609|"     This study will test a new MRI sequence that measures cerebral blood flow (CBF). Because this     technique for measuring CBF is new, there is little information on what the normal values for     different regions of the brain should be. Information from the study will be used to     establish normative CBF values for the brain, improving the reliable use of this technique     for the diagnosis of brain injury or disease.   "
39577|NCT02767596|"     The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide to     achieve glycemic control in type 2 diabetes patients, in patients with failure of long acting     GLP-1 analog.      Patients who fail to achieve significant improvement in diabetes control on basal insulin and     Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks. The     primary outcomes will be changes in HBA1C and weight.   "
39578|NCT02767583|"     Background / rational:      Obesity is associated with significant comorbidities including type 2 diabetes (insulin     resistance), heart disease, stroke, hypertension, sleep apnea syndrome, dyslipidemia, cancer,     hepatobiliary diseases, orthopedic complications and psychosocial impact 1 .      Peripheral neuropathy is a known complication in the type I and II diabetes and glucose     intolerance and metabolic syndrome in 2. Outside of diabetes (type I and II) that are     associated with cardiovascular risk high vascular, presence of metabolic syndrome constitutes     in itself a well demonstrated vascular risk factor. Its definition requires the presence of     three elements from the following 5: abdominal obesity (high waist circumference), high blood     pressure, high fasting blood sugar, high triglycerides and / low HDL-cholesterol 3.      This peripheral neuropathy predominantly affects sensory fibers of small poorly myelinated     diameter (Aδ fibers and C) and autonomous sensory fibers and is called small fiber neuropathy     4. The cardinal sign of NAION is the presence of neuropathic pain but abnormalities in     physical examination are often absent and conventional electromyography is faulted to make     the diagnosis. These small fibers are also constituent of the autonomic nervous system and     causes damage autonomic dysfunction that can manifest the cardiovascular system (hypotension,     cardiac conduction disorders), digestive, sweat, sphincter. neuropathy of the diagnosis of     small fibers is suggested clinically by the presence of neuropathic pain often contrasting     with a normal clinical examination. The confirmation is based on electrophysiology with     various techniques and quantification of intra-epidermal nerve fibers.      Main objective / secondary:      Primary objective :      To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese     patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C     autonomic      Secondary objectives:        -  Evaluation of the prevalence of occurrence of peripheral neuropathy by Sudoscan® during          follow-up after treatment of obese patients with bariatric surgery (months) M1, 3, 6, 9,          12.        -  Correlation of results obtained Sudoscan® quantitative sensory testing (QST) Thermotest®          evaluating small sensory fibers Aδ, among non-operated non-diabetic obese patients and          in the postoperative follow-up (months) M1, 3, 6, 9, 12.        -  Characterization of electromyographic parameters (motor and sensory conduction) in          patients with a skin conductance measured by lowered Sudoscan® and / or a threshold of          sensitivity to pain increased Thermotest®.        -  Correlation between the presence of a small fiber neuropathy in non-diabetic obese          subjects with clinical and biological parameters collected.      Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5     patients included / week of 15 patients collected in central obesity / week) including 12     months of inclusion.      Number of topics to include: 100 over a period of one year to adjust to the rhythm of the     inclusions.      As mentioned, patients will be a measure of impedance of the skin to products chlorine ions     by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for     the detection of violations neuropathic (cf. references and CE certificate attached to the     dossier).      The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see     references and CE certificate attached to the dossier).      Our center has gained experience of these techniques for the detection of peripheral     neuropathy in several patient populations (diabetes and cancer in particular); manipulators     (doctors and technicians) are trained in these techniques.   "
39579|NCT02767570|"     Nearly one out of every two Americans will develop knee osteoarthritis by age 85. Over 20     million Americans, including nearly three million Veterans, currently have painful knee     arthritis that limits their daily activity or recreation. The vast majority of those     individuals will be prescribed anti-inflammatory drugs that provide some pain relief but do     not slow the progression of the disease. Often people with knee arthritis are told they must     live with the pain until they become appropriate candidates for knee replacement surgery, but     that can require tolerating the pain and limiting function for many years. Because of other     health issues, some individuals are never acceptable surgery candidates. What is desperately     needed are better conservative approaches for treating these patients. Two such approaches     will be tested and compared in this study.   "
39582|NCT02767531|"     Patients with Type I Hyperlipoproteinemia (T1HLP) have a rare form of hypertriglyceridemia     marked by significant chylomicronemia and recurrent episodes of acute pancreatitis. T1HLP is     caused by a deficiency of lipoprotein lipase or one of its cofactors. Many patients are a     challenge to treat, as the only effective therapy available is an extremely low fat diet.     This diet is exceedingly difficult to follow, and despite adherence, many patients still have     chylomicronemia and develop acute pancreatitis.      Specific Aim: To determine the efficacy of a gastric and pancreatic lipase inhibitor,     Orlistat, in reducing serum triglyceride levels in patients with T1HLP.   "
39583|NCT02767518|"     This is a 2-group study comparing the effect of a prehabilitation program to usual care on     quality of life and clinical outcomes in patients undergoing elective repair of their     thoracic aorta.   "
39584|NCT02767505|"     This is nationwide registry-based randomized clinical multicenter trial in which patients     will be randomized to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary     endpoint are weight control over 5 years and the amount of severe adverse events.     Additionally the investigators have predefined a number of secondary endpoints, and the trial     has a sufficient number of patients to allow comparisons across subgroups.   "
39585|NCT02767492|"     This study will include patients who are diagnosed with knee OA and are recommended for a     knee injection. Study subjects will be randomized to receive either the standard of care knee     injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked     for permission for a baseline knee aspiration prior to the knee injection. At 6 months     post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be     followed for 1 year post-injection to include range of motion measurements and     patient-reported pain/functional outcome measurements. X-rays will also be taken at the     1-year post-injection appointment.   "
39586|NCT02767479|"     Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and     CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication     rates are compared. Patients who have ever failed in eradication by CAM-based regimen are     treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg     bid, AMPC 750 mg bid and MNZ 250 mg bid.   "
39587|NCT02767466|"     Using a single blind within-subject design, 16 patients with neurological disorders were     randomly exposed to two different treatments: physical therapy and robotic assisted gait     training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was     used to assess the effects on the treatment on distinct affective states. The subscales of     the MSS were tested for pre-post changes and different effects between treatments with     non-parametric tests.   "
39588|NCT02767453|"     The purpose of this study is to determine the limited effectiveness of drains during Total     Shoulder Arthroplasty. Drains are used during joint arthroplasty procedures to decrease     infection rates, swelling,and the number of dressing changes required during a hospital stay.     The use of drains has been heavily investigated in the hip and knee replacement literature,     but there have been no investigations regarding their use in shoulder replacements, despite     frequent use.      Clinical benefit has not been consistently documented regarding drain usage in hip and knee     arthroplasty and the investigators hypothesize that they are of limited utility in total     shoulder arthroplasty as well. The investigators will perform a prospective investigation of     total shoulder arthroplasty patients- dividing them into two groups- half will receive a     drain at the time of surgery and the other half will not be receiving a drain.   "
39600|NCT02767297|"     To determine the relative bioavailability of the capsule (reference) and tablet (test)     formulations of FDL169 in healthy adult males and females, and to evaluate the     pharmacokinetic (PK) profile FDL169 tablets (test formulation) in both healthy adult males     and females, and subjects with cystic fibrosis (CF).   "
39589|NCT02767440|"     Current models of outpatient childhood obesity treatment focus on the child's health habits,     with limited efficacy. In part, this may be because childhood obesity is highly sensitive to     parental lifestyle habits, who are often not a direct target of child obesity interventions.     This study aims to target weight loss among overweight parents of 2-16 year old children with     obesity enrolled in the Duke Healthy Lifestyles Program (HL) in order to augment child body     mass index reduction. The intervention,  Families on Track is a digital health intervention     platform using the Interactive Obesity Treatment Approach (iOTA).   "
39590|NCT02767427|"     The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine     wipes provide no added benefit to decreasing microbial activity or preventing surgical site     infections.      Patients will be randomized to the chlorhexidine or no additional intervention groups.     Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no     additional intervention. Those randomized into the chlorhexidine gluconate home-application     group will be asked to shower the night before surgery, and to use a standardized     pre-packaged chlorhexidine gluconate wipe (that the patients would receive at their     pre-surgical consultation) on their surgical site after thoroughly drying those areas. The     patients will be asked to use a second wipe in each area the morning of surgery. The surgical     sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these     two groups will be randomized separately. All patients will undergo a standardized     preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol     solution. Then, the surgical site (either the anterior portion of the neck or the posterior     area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with     chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon     preference. Cutaneous samples will be taken from the surgical site of each patient at each     time point.   "
39591|NCT02767414|"     The primary purpose of this study is to validate the sensitivity and specificity of the     Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold     standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).      The secondary aims are to:      Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in     detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase     Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu     Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the     convenience, comfort and ease of use of the Respirio Flu Test.   "
39593|NCT02767388|"     Broadly speaking, the goal of this study is to better understand the influence of     chemotherapy treatment on the cognitive and neural mechanisms underlying human behavior.     Extant literature lacks diversity in studied cancer populations and treatment protocols, and     provides limited understanding of the cognitive abilities that are impaired by chemotherapy.     To overcome these limitations, this study will employ a sophisticated battery of tests on an     understudied cancer population. Eligible participants will either be patients diagnosed with     hematological malignancy (HM) or demographically matched healthy control patients.      After HM diagnosis and treatment protocols have been established, patients will be inducted     into the longitudinal study comprised of three visits: 1) after diagnosis but prior to     chemotherapy treatment (baseline), 2) after one treatment cycle (one month post-baseline),     and 3) after three treatment cycles (three months post-baseline). Patients will undergo a     test battery designed to measure specific behavioral and neural mechanisms of attention;     tests will either be computer-based cognitive tasks or simulated driving tests that immerse     patients into virtual driving scenarios. During each test, EEG will be concurrently measured     through non-invasive scalp electrophysiology recordings; EEG recordings will reveal     underlying neural mechanisms affected by chemotherapy. Additionally, neuropsychological tests     of vision, attention, and memory will be administered, as well as questionnaires to evaluate     health, mobility, and life space. Finally, blood samples will be collected to examine levels     of circulating inflammation-specific proteins typically present in cancer patients. This     study will allow us to better understand the mechanisms through which chemotherapy influences     cognitive performance. Results from this study will influence the administration of     chemotherapy treatments so that patients can continue to receive the highest medical care     while maintaining optimal cognitive abilities and quality of life.   "
39594|NCT02767375|"     To study if the addition of HAIC following complete removal of early stage liver cancer of     HCC will prevent or delay the recurrence of the disease. Half of the participant will receive     two cycles of the HAIC after the hepatectomy, while the other half will return to the     baseline surveillance schedule.   "
39595|NCT02767362|"     This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese     women who are to undergo surgical staging for endometrial cancer.   "
39596|NCT02767349|"     An open-label study of the pharmacokinetics (PK) and safety of MNK-155 in postsurgical     adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will     assess the safety of administering multiple doses of MNK-155 in this population.   "
39597|NCT02767336|"     Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for     Use and Marketing Claims Evaluation.   "
39598|NCT02767323|"     Cognitive decline and dementia have become important public health issues in our time as     medical science has increased lifespan and our society becomes progressively older. A great     deal of the cognitive decline due to aging can be explained by decline in working memory     (WM), a mental function central to cognition in which aging deficits appear almost     universally. Attempts to use WM training to increase WM ability in older adults has had some     success, but the transfer of performance enhancements caused by this training to other     cognitive skills is controversial. Another intervention that shows much promise is     noninvasive stimulation of cerebral cortex using transcranial magnetic stimulation (TMS),     which has been shown to increase performance in many cognitive tasks. Here, the investigator     proposes to use fMRI-guided TMS enhancement paradigm to stimulate dorsolateral prefrontal     cortex (DLPFC), a region involved not only in the maintenance of items in WM, but also in     their manipulation, in order to create WM performance enhancements that will be long lasting     and that will transfer to other cognitive tasks as well. This will be achieved through three     studies. In the first the investigator will stimulate both old and young healthy adults while     they perform different WM tasks that will increasingly engage DLPFC in order to demonstrate     enhancement of WM performance that is greater in the older adults. In the second and third     studies, older adults will receive active or sham TMS over two weeks of daily sessions while     they perform the WM tasks. In the second study, the investigator hopes to demonstrate that     the cumulative effect of multiple TMS sessions, in tandem with the synergistic effects of     simultaneous TMS + WM training, create WM performance enhancements greater than those found     with WM training alone, whose effects are long-lasting, continuing a month following the     course of TMS sessions. In the third, the investigator will investigate whether the WM     enhancements generated by the two weeks of TMS sessions will generalize to other cognitive     tasks. Success of these studies will provide proof in principle for long-lasting,     transferable effects of TMS in remediating WM and more general cognitive deficits due to     aging, and point to a possible non-invasive brain stimulation therapy for cognitive decline     in healthy aging and in dementia.   "
39599|NCT02767310|"     The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20     mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.   "
39601|NCT02767284|"     This study evaluates the relative performance of different methods to measure the human     spectral contrast sensitivity function (CSF).   "
39604|NCT02767245|"     Thyrotoxicosis is a hypermetabolic state in which there is increased utilization of thiamine.     Thiamine deficiency has been observed in association with hyperthyroidism. Several studies     documented that thiamine treatment could improve signs and symptoms of congestive heart     failure, or even improve left ventricular ejection fraction in patients without     thyrotoxicosis. This pilot study aims to evaluate prevalence of thiamine deficiency and     assess improvement of cardiovascular function after receiving thiamine supplement in     thyrotoxic patients.   "
39605|NCT02767232|"     The purpose of this study is to determine if the use of adjunctive catheter-directed     thrombolysis (CDT), which includes the intrathrombus administration of rt-PA     (Activase/Alteplase), can prevent post-thrombotic syndrome (PTS) in pediatric patients with     symptomatic proximal deep vein thrombosis (DVT) as compared with optimal standard     anticoagulation alone.   "
39606|NCT02767219|"     This is a phase III randomised controlled pilot study which aims to assess the effectiveness     of the use of bevacizumab in patients who have undergone trabeculectomy surgery, which appear     to be showing early signs of failure.   "
39607|NCT02767206|"     The study aims to evaluate the feasibility of transnasal endoscopy in patients with portal     hypertension, cirrhotic and non-cirrhotic. The incidence of the procedure's adverse effects,     the patient's tolerance and his/her opinion about the exam are analyzed. In addition, the     interobserver matched for the discoveries found in the study is carried out.   "
39608|NCT02767193|"     single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective,     placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the     following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells     with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with     pegylated interferon.   "
39609|NCT02767180|"     An ICU-specific questionnaire for patient reported outcome measures (PROM) after critical     care will be tested in a study of 650 patients recruited six months to three years after     discharge from the ICU, and 150 controls who have not been critically ill, matched for age     and sex. The questionnaire is sent by mail after an invitation letter followed by a phone     call and returned in a pre-stamped envelope. It is then scanned and data imported digitally.     Medical data from the ICU-stay can be added. Further analyses after comparison with the     control population and item reduction will follow.   "
39610|NCT02767167|"     Iodine is an essential trace element necessary for the synthesis of thyroid hormones which     are critical for human growth and development throughout the lifecycle. Iodine is     particularly important during pregnancy and infancy for brain and neurological development.     Severe iodine deficiency during pregnancy can cause severe mental impairment and stillbirth     while mild-to-moderate deficiency has been associated with impaired infant development. As     such, pregnant women and women of child-bearing age are particularly vulnerable to the     effects of iodine deficiency.      Globally, 241 million (30%) school aged children are iodine deficient. Historically, the UK     and Ireland were believed to be iodine sufficient but concern has been expressed in the last     decade regarding the iodine status of the UK and Irish populations. A study of Irish women in     2004 reported 55% of pregnant women in their sample population to be moderately iodine     deficient and 53% of non-pregnant women to be moderately iodine deficient. A study of UK     schoolgirls found that 51% were mildly iodine deficient and 16% were moderately deficient.     Importantly, the prevalence of iodine deficiency was highest in Northern Ireland where 85% of     those sampled were iodine deficient.      Iodine is known to interact with selenium in the conversion of the thyroid hormone thyroxine     (T4) to the metabolically active triiodothyonine (T3) hormone. Selenium is also important for     immune, cardiovascular and cognitive function. Selenium status has been reported to be     moderately low using pooled English data on blood selenium concentrations from 1984 to 1992.     In addition, the latest National Diet and Nutrition Survey reports that selenium intakes are     below recommendations for several population groups including women of childbearing age where     mean selenium intakes are 76% of the recommended 60µg/day. This national survey also reported     that 49% of women aged 19-64 years failed to meet the lower reference nutrient intake of     40µg/day.      Milk and dairy products are the major source of iodine for the UK population and are also a     source of selenium. The contribution of milk and dairy products to iodine and selenium     intakes is greatest in adult females (35% and 6% respectively). Observational evidence has     repeatedly reported milk consumption to be positively correlated with iodine status and     iodine intakes. Research in Iceland and New Zealand has reported that milk consumption is not     associated with selenium status; however it is unknown if this is true for the UK population.      To date, no randomised controlled trial has examined the effect of milk consumption on either     iodine or selenium status. The possibility of increasing iodine and selenium intake by     increasing milk consumption, a widely available and consumed foodstuff, in a population group     vulnerable to micronutrient deficiency should be investigated. This would add valuable data     to the knowledge base for iodine, where there is ongoing debate over the most appropriate     means of increasing iodine intake amongst women of childbearing age in the UK where salt     iodisation, the key strategy in preventing deficiency, is not implemented.      The aim of this study is to investigate the impact of cow's milk consumption on the     biological status of iodine and selenium among women of child-bearing age.      The study will be a 12 week randomised-controlled human intervention study. Participants will     be randomised to consume additional semi-skimmed milk in the Following amounts, control group     (0mls/day), intervention group (430mls/day or 3l per week).   "
39611|NCT02767154|"     This study will compare two priming solutions for extracorporeal circulation, one based on     Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure     during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ     functions.   "
39612|NCT02767141|"     Children without consistent access to sufficient and nutritious food show sustained     disadvantages. To improve food security, households utilize three types of coping strategies-     participating in governmental feeding and financial assistance programs; obtaining food from     nongovernment providers; and using individually developed strategies. To understand the     interdependencies among strategies and decision-making processes used to select them, the     investigators conducted a two-phased, mixed-methods study using a socio-ecological     theoretical framework. First, employing a cross sectional, observational design the     investigators administered in-person surveys to 320 adults in very low food secure (VLFS)     households with children. Over 1 year later, the investigators repeated select questions and     conducted in depth interviews with a cohort (n=28) of participants. Descriptive statistics     defined magnitude of associations among strategies. Following bivariate analysis, the     investigators assessed interdependencies and factors affecting relationships with log-linear     models. The investigators analyzed interviews using an hierarchically ordered, analytical     coding structure. With Qualitative Comparative Analysis (QCA), the investigators developed     typologies of VLFS and created models treating food security as an outcome. The association     of soup kitchen use and nutritionally risky behavior was altered by Supplemental Security     Income (SSI) or Social Security Disability Insurance (SSDI). Food safety-related risky     behavior level related to intensity of food pantry use by participation in school food     programs. Supplemental Nutrition Assistance Program (SNAP) did not affect the association     between soup kitchen use and risky food safety behaviors. Key interview constructs included     becoming and being short of food; coping strategies; decisions used to inform choice of     strategies; and managing a devalued social status. Improved income stability was a necessary     condition for improving food security.   "
39613|NCT02767128|"     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered     orally in healthy adult volunteers. It is a randomized multiple treatments, single dose     study.   "
39614|NCT02767115|"     The aim of this study was to formulate a mucoadhesive gel of grapes seed extract (GSE)     followed by short-term clinical study for the effectiveness of this gel onto the pocket depth     (PD), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) when applied in     periodontal pockets as an adjunct treatment for chronic periodontitis.   "
39615|NCT02767102|"     Melatonin (MLT) is a bioactive compound in red wine. The investigators will investigate the     serum and salivary concentrations and antioxidant power of MLT after the intake of a glass of     red wine. Twelve healthy volunteers were recruited to receive both 125 mL of red wine rich in     MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind     design. Serum and salivary MLT will be measured by liquid chromatography coupled to mass     spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion     reducing antioxidant power (FRAP) will be analyzed.   "
39616|NCT02767089|"     The purpose of this study is to further access the utility of biochemical and clinical     biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against     which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult     healthy volunteers.   "
39617|NCT02767076|"     To identify the value of using the ultrasound in applying a commonly used regional     anaesthetic procedure (spinal anaesthesia) when compared with the conventional landmark     guided approach, regarding the efficiency of the anaesthetic technique, incidence of     associated common complications and patient's satisfaction.   "
39640|NCT02766764|"     Two hundred and thirty women with expected poor ovarian response undergoing IVF/ICSI will be     randomly divided into 2 equal groups using computer generated random numbers. Group 1 will     receive DHEA 25 mg (DHEA 25mg, Natrol , USA) t.d.s for 12 weeks before starting IVF/ICSI     cycle in addition to Growth hormone (GH; Somatotropin, Sedico, Egypt) 4 IU on day 6 of human     menopausal gonadotropin (hMG) stimulation in a daily dose of 2.5 mg subcutaneous (sc) until     the day of human chorionic gonadotropin (hCG) triggering Group 2 will receive an oral placebo     t.d.s. daily for 12 weeks before ICSI in addition to a sc placebo similar to GH daily from     day 6 of stimulation until the day of hCG trigger.   "
39641|NCT02766751|"     This study is designed to look at two different programs that may help people who are HIV+     and have pain and depression. The investigators are trying to understand how to help people     learn to live better lives even with these chronic illnesses.   "
39618|NCT02767063|"     Patients will be randomized in phase II trials to continue on the same TKI versus one of the     alternative treatment approaches. If a patient is not eligible for one of the treatments, he     (she) will be randomized between the options for which he (she) is eligible.      The trial will start with current available treatment options (experimental arms). New     available treatment options may be open at any times later on. Authorized TKIs are imatinib,     nilotinib, dasatinib, bosutinib and ponatinib.      For all options the treatment duration is for a minimum of 12 months and will be continued in     the absence of adverse events following investigator decision. Each therapeutic option will     be detailed in term of combination modalities, dose, dose adaptation, specific warnings,     specific exclusion and inclusion criteria. The decision to introduce a new option will depend     on the general pace of recruitment and on the assessment of the potential efficacy and safety     of the new treatment, and will be implemented after scientific review by a protocol     amendment.      Primary objective:      A. To select molecules in combination or sequentially with imatinib, nilotinib, dasatinib,     bosutinib or ponatinib potentially able to produce a 25% increase in the Cumulative Incidence     of MR4.5 as compare to control.      Secondary objectives:      A. To determine the safety of selected therapies      B. To determine the rate of MR4 by 12, 24, 36, 48 months in experimental and control arms      C. To determine the rates of MR4.5 by 24, 36, 48 months in experimental and control arms      D. To determine the rate of undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies)     by 12, 24, 36, 48 months in experimental and control arms      E. To estimate treatment free remission (TFR) in patients eligible for discontinuation     studies      F. To investigate the relationship between biological activity and the clinical efficacy of     the selected therapies      G. To assess the effects of the treatments on the number and clonogenicity of CML stem cells     and other biological markers of interest      H. To estimate duration of response, progression-free survival, event free survival and     overall survival.   "
39619|NCT02767050|"     The following observational study evaluates incidence of caries in smoking and smokeless     tobacco based on habit history by clinical examination and DMFT index.   "
39620|NCT02767037|"     Currently, there is no clear diagnostic test that can be used to confirm the diagnosis of     Parkinson's disease, or a biomarker that can track its progression. Patients with Parkinson's     have many abnormalities of the autonomic nervous system, which may be related to Parkinson's     changes outside of the brain. A new device called the SudoScan, which measures autonomic     sweating changes, may be a simple way to test for autonomic changes in Parkinson's.      The investigator plan to see whether SudoScan can identify Parkinson's disease and whether     SudoScan abnormalities might be present even in early (prodromal) Parkinson's stages.      The investigator will assess SudoScan in a group of Parkinson's patients, normal healthy     controls, patients with non-Parkinson's neurodegeneration, and patients with REM sleep     behavior disorder (an early/prodromal Parkinson's state). Abnormalities will be correlated     with standard autonomic tests and with skin biopsy findings Parkinson's degeneration in the     peripheral autonomic fibers.      If the investigator can find a reliable way to diagnose and follow Parkinson's disease, he     will be able to correctly identify Parkinson's (even in its earliest stages). This will     improve the chance to find protective treatments against Parkinson's, by preventing false     diagnosis and by providing a new marker to track disease progression.      If successful, the investigator will aim to validate the findings on a large sample of     Parkinson's and also to track changes over time in the original cohorts   "
39622|NCT02767011|"     Abstract:      It is intuitive that post discharge surgical complications are associated with increased     patient dissatisfaction, and directly associated with an increase in medical expenditures. It     is also easy to make the connection that many post hospital discharge surgical complications     including surgical site infections could be influenced or exacerbated by patient     co-morbidities. The authors of a recent study reported that female gender, obesity, diabetes,     smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive     pulmonary disease, dyspnea, and neurologic disease were all of among significant predictors     of surgical site infections after vascular reconstruction was performed. The main concern for     optimal patient care especially in geographically isolated areas of West Virginia is to have     early, expeditious, and prompt diagnosis of early surgical site infection with subsequent     indicated interventions. This theme will lead to patient satisfaction, minimizing third party     interventions and decrease the total cost associated with these complications. Nevertheless,     it seems reasonable to believe that monitoring using telehealth technology and managing the     general health care patients receive after a hospital vascular intervention will improve     overall health and reduce post-operative complications.      Aims/Objectives:      1. The primary objective of the current project is to compare early and late outcomes for     patients who receive post discharge health care monitoring (which includes using Telehealth     electronic monitoring; THEM) to patients who receive standard of care (SOC) and routine     discharge instructions and no monitoring.      Methods:        1. Randomize patients who are scheduled to have revascularization interventions with groin          incisions to receive either telehealth electronic health care monitoring or normal          standard of follow-up care.        2. Follow patients for 4 weeks, record any 30-day hospital readmissions or complications.          In addition, have participants complete the follow-up survey questionnaires.   "
39623|NCT02766998|"     This is a prospective, single center, safety and feasibility trial to evaluate the use of     autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be     identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital     heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram.     At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a     sterile fashion and the umbilical vein will be dissected free and preserved until first     clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will     be followed until their Stage II palliative procedure.   "
39624|NCT02766985|"     The purpose of this study is to make a standardized and scalable Rasch-built clinical     severity scale to help in finding genetic and environmental modifiers of disease in     Facioscapulohumeral muscular dystrophy (FSHD).   "
39625|NCT02766972|"     Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date.     Therefore, advanced techniques are required to achieve an optimal result in treating these     patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to     facilitate microsurgical clip-reconstruction has been studied prospectively in a joined     neurosurgical, anesthesiological and cardiological study.   "
39642|NCT02766738|"     This study aims to test which of three exercise programs, previously demonstrated valuable     for residential aged care adults, has the greatest benefit for walking speed and the     spatiotemporal parameters that define it. The programs to be included are:        1. The GrACE program and        2. The GrACE plus Gait specific training.   "
39643|NCT02766725|"     The aim of this study was to develop and characterize in situ thermosensitive gels for the     vaginal administration of sildenafil as a potential treatment of the endometrial thinning     that occurs as a result of the use of clomiphene citrate in induction of ovulation in women     with World Health Organization type II EU gonadotrophic anovulation.   "
39644|NCT02766712|"     This is a two arm randomized, paired prospective study comparing the percentage of time spent     above Contact Force (CF), Force Time Integral (FTI) and other lesion parameters in the     setting of pacing versus non-pacing. This study is designed to compare the percentage of time     spent above CF 10 grams between paced and non-paced lesions at 15 pre-determined lesion     locations.   "
39626|NCT02766959|"     This single-site, within-subject experimental basic research study is designed to analyze the     hypothesis that allele-specific expression of the bitter taste receptor T2R38 in taste tissue     of individuals heterozygous for the taste receptor gene TAS2R38 correlates with that in nasal     epithelium, and is responsible for differences in acyl-homoserine lactone-induced respiratory     defenses. Subjects will include 100 predominantly European adults without chronic     rhinosinusitis who will be undergoing a sinonasal procedure for reconstructive purposes. All     subjects will provide saliva samples for genotyping, from which 25 subjects heterozygous for     TAS2R38 (AVI/PAV) will be identified. These individuals will be asked to complete a beverage     frequency questionnaire and taste test prior to the procedure that will evaluate for a number     of compounds, among them bitter ligands specific to T2R38. Their tongue will also be     photographed to evaluate the anatomy of their fungiform papillae, the mushroom-like     structures on the tongue which contain taste buds. Subjects will subsequently provide nasal     epithelium and taste tissue, which will be processed to 1) evaluate for allele-specific     expression of TAS2R38 mRNA in both the taste and nasal tissue, with the nasal tissue     concurrently being cultured in an air-liquid interface system to 2) assess the AHL-induced     respiratory defenses of ciliary beat frequency (CBF) and nitric oxide (NO) production. Should     subjects require a subsequent sinonasal procedure for clinically-determined reasons, taste     and nasal tissue will again be obtained and analyzed for TAS2R38 mRNA, allowing for 3)     longitudinal evaluation of mRNA expression level.   "
39627|NCT02766946|"     Ventilatory support during critical phase result in inactivity of respiratory muscles     especially diaphragm muscle. These inactivity also result in change of contractile capability     and quick muscular atrophy.      The aim of the study is to visualize the evolution of diaphragm thickness by echography     during Mechanical Ventilation for patients with septic shock or acute respiratory distress     syndrome and to compare with the evolution for patients under non-invasive ventilation and     those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10     (if patient still under a mode of ventilation or in the unit).      The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy,     which is not involved in ventilation, in order to assess respective effect of ventilatory     inactivity and undernutrition linked to intensive care.   "
39628|NCT02766933|"     The natural history and response to therapy of chronic hepatitis B infection in West Africa     are currently poorly understood. In this study, employees of the Cameroon Baptist Convention     Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will     be offered enrollment. Disease monitoring and treatment will be provided following current     WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens     will be frozen for future analysis.   "
39629|NCT02766907|"     Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic     membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize     the ocular surface integrity and intraocular lens calculation before cataract surgery.   "
39632|NCT02766868|"     Patients with refractory and relapse lymphoblastic leukemia had poor outcome even with marrow     ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. In this study, we focus on a new     treatment strategy with high-dose chemotherapy regimen consisting of     fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning     regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.   "
39633|NCT02766855|"     The aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the     treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.   "
39634|NCT02766842|"     Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent     structures, such as lymph nodes, is still showing advancements especially with the increased     use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine     needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The     purpose of the study is to compare between the currently used, ProCore needles and the new     biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.   "
39635|NCT02766829|"     The study aimed to compare successful spinal needle placement between crossed leg sitting     position and traditional sitting position in patients underwent urology surgery.   "
39636|NCT02766816|"     Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World     Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study     will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study     will also assess lot-to-lot consistency among three lots of BBio bOPV.   "
39637|NCT02766803|"     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of     reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated     ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces     androgen production.      This study is designed to evaluate the endocrine and metabolic effects of simvastatin and     resveratrol on PCOS.      Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects     of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering     20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined     according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after     3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and     the fasting insulin level.   "
39638|NCT02766790|"     TA-65 MD® is pure, natural, plant-based compound that can help maintain or rebuild telomeres.     A telomere is a region of repetitive DNA at the end of a chromosome, which protects the end     of the chromosome from deterioration. They shorten during cell division and eventually signal     an irreversible state of growth arrest known as cellular senescence. The length of a person's     telomeres is an indicator of his or her overall health status; short telomeres have been     associated with cellular aging and dysfunction.   "
39645|NCT02766699|"     The purpose of the Cerebral EDV study is to determine the safety and tolerability of     EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The     study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is     effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).   "
39646|NCT02766686|"     ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients     suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe     genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events     (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain     assessment of quality of life, biochemical recurrence and recurrence free survival as well as     overall survival and economic comparison between photon and proton therapy.   "
39647|NCT02766673|"     Currently several dose schedules of Albuterol are administered via nebulization to infants in     the neonatal and infant intensive care unit (N/IICU). As Albuterol is not FDA approved for     this population (under 2 years) there is no standard recommended dose. Aerosolized Albuterol     is one of the most widely used therapies that are utilized for infants with chronic lung     disease. The common practice in the N/IICU is weight base dosing of all medications. This     contradicts the aerosol science recommendations, which advise not to titrate doses by weight     as the patient naturally self-regulates their dose according to the change in minute     ventilation with age. In addition, the wide use of aerosolized Albuterol in the infant with     Bronchopulmonary Dysplasia (BPD) has little current evidence of efficacy in this disease.     Understanding the appropriate dose for effective treatment as well as the indication for use     in the BPD population would provide the clinician with useful guidelines.      The investigators propose to analyze the safety and efficacy of aerosolized albuterol in     infants with BPD comparing the recommended dose per aerosolization literature with the common     dosing practices at The Children's Hospital of Philadelphia (CHOP) as well as placebo.   "
39648|NCT02766660|"     The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL),     macula and optical disc parameters obtained by optical coherence tomography (OCT), and     intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO)     and healthy controls.   "
39649|NCT02766647|"     This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is     approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds     of white blood cells (WBC) known as neutrophils. This type of white cell is important in     fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by     increasing the number of neutrophils that are produced in the body.      This is important for patients who have low neutrophils due to chemotherapy, other treatments     such as bone marrow transplant or certain other conditions with symptoms/problems related to     low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in     the body compared to Neupogen®.   "
39677|NCT02766270|"     The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO     II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that     lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation     (TERTp-mut) had dismal clinical outcomes. These results suggested that current treatment     strategies are not adequate for this subtype of lower-grade glioma.      The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy     with temozolomide followed by adjuvant temozolomide for lower- grade glioma patients with     IDH-wt and TERTp-mut.   "
39650|NCT02766634|"     This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is     approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds     of white blood cells (WBC) known as neutrophils. This type of white cell is important in     fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by     increasing the number of neutrophils that are produced in the body.      This is important for patients who have low neutrophils due to chemotherapy, other treatments     such as bone marrow transplant or certain other conditions with symptoms/problems related to     low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in     the body compared to Neupogen®.   "
39651|NCT02766621|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of     PF 06823859 in healthy subjects.   "
39652|NCT02766608|"     This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung     function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320     μg, and open-label Symbicort® TBH (200/6 μg) administered BID.   "
39653|NCT02766595|"     Children referred for routine EEG studies for suspected absence seizures will be asked, upon     caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine     position and while sitting up. We aim to demonstrate that hyperventilation is more effective     in eliciting absence seizures in a sitting position than while lying down.   "
39654|NCT02766582|"     Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the     Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary     peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin     every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by maintenance     pembrolizumab IV.   "
39655|NCT02766569|"     The IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II     device in patients with closure of secundum atrial septal defects (ASD II).   "
39656|NCT02766556|"     The present study was designed to test the hypothesis that dexmedetomidine added to     ropivacaine for interscalene brachial plexus blocks for elective shoulder surgery would     enhance the duration and effect of analgesia when compared with ropivacaine alone, and their     influence on serum IL-6, cortisol, IL-1beta, IL-8, and substance p.   "
39657|NCT02766543|"     A prospective, multi-center, single-arm study, planned in 110 patients. The primary objective     of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging     (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate     tissue of patients with localized, organ-confined prostate cancer.   "
39658|NCT02766530|"     The investigators will use integrated PET/MR for the goals below:        1. Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced          MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to          monitor treatment response.        2. Use of dynamic and static PET to monitor treatment response for NAC, and to investigate          the correlation of PET results versus MRS, DCE MRI.        3. Compare clinical staging by PET/MR and by clinical assessment.        4. On pre-chemotherapy studies, to investigate the association of molecular marker status          with the dynamic and static PET, MRS and DCE MRI parameters.   "
39661|NCT02766491|"     Cerebral palsy (CP) has a prevalence of 1.5-3 per 1000 live births, making it the most common     neurological disorder among children in Europe. One of the most frequently observed problems     in CP is hypertonia, i.e. increased muscle tension, which can result in contractures.     Stretching therapies are widely used as a treatment for contractures, but with highly     variable success. Therefore, efforts are needed to improve the efficacy of stretching     interventions. The investigators hypothesise that increasing the stiffness of the tendon     relative to the muscle, by resistance training, prior to stretching will improve the efficacy     of stretching interventions in children with CP. In a RCT design the investigators will     compare a group of children receiving a combined strengthening-stretching intervention of the     calf muscle to a control group receiving conventional stretching exercises in combination     with upper limb exercises. Outcome measures will include muscle-tendon structure and gait     analysis to assess functional improvements. This research will improve the understanding of     muscle responses to stretching interventions in children with CP and can lead to more     effective stretching therapies.   "
39662|NCT02766478|"     Genistein is a natural supplement that comes from soy. The purpose of this study is to see if     genistein has any effect on preventing or reducing heart disease and diabetes risk in men     receiving Androgen Deprivation Therapy for prostate cancer. A combination of nutritional     measures, blood markers and imaging tools will assess body composition, lipid levels and     insulin resistance. Information from this pilot study will increase understanding of     interventions which may prevent or reduce health risks during prostate cancer treatment. This     project involves 24 men who will receive androgen deprivation therapy for prostate cancer.   "
39664|NCT02766452|"     The objectives of this study were to evaluate the effect of a preoperative educational DVD on     parents' knowledge acquisition, participation and anxiety related to their child's care in     the recovery room (RR). It also aimed at evaluating the DVD in terms of children's     postoperative distress, pain, analgesic requirements and length of recovery.   "
39665|NCT02766439|"     between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg     etanercept injection subcutaneously twice a week. The follow-up time of the study was 24     weeks.   "
39666|NCT02766426|"     Sincev the adipose tissue as been identified as a metabolic active tissue that produces and     regulates pro-inflammatory factors, the investigators studied the relationship between     cytokine changes and maternal body composition.      The investigators evaluated plasmatic pro- and anti-inflammatory cytokines levels in pregnant     women with BMI >25 Kg/m^2 undergoing a lifestyle change program, and if this is related with     changes in body composition.      Women enrolled in the study were provided nutritional advices about lifestyle: a proper     nutrition and a constant physical activity (30 minutes/day, 3 times/week, according to the     American College of Obstetricians and Gynecologists Guidelines) in an integrated counselling     with a dietitian and a gynaecologist, both attendant since the enrollment.      Plasma pro- and anti-inflammatory markers were investigated at enrollment (9-12 weeks) and at     36-38 weeks.      Furthermore, the investigators used the bioimpedance analyzer to evaluate changes of body     composition (i.e. fat mass and fat free mass) at first and third trimester.   "
39667|NCT02766400|"     Individuals with cognitive impairments after stroke sustain significant disability in their     daily tasks, and account for a significant proportion of stroke-related healthcare costs.     This loss of independence is costly because individuals with stroke-related cognitive     impairments require more rehabilitation and more resources to support their living, whether     in institutional or community settings. The proposed study examines the effects of directed     and guided training on the recovery of independence with daily activities in adults with     stroke-related cognitive impairments in acute rehabilitation. The investigators predict that     patients in both groups will demonstrate significant improvement in independence with daily     activities in the first 12 months after rehabilitation admission, but that patients who     receive guided training will demonstrate significantly more improvements than patients who     received directed training.   "
39668|NCT02766387|"     Lower limb amputation (LLA) is a major public health problem, with significant human and     financial impact. Epidemiological data remain scarce in the literature. The primary objective     of the equipment of lower limb amputees is to give a walking ability and autonomy that are     closest to the previous state before the amputation. About microprocessor-controlled     prosthetic knees (MPKs), there are currently three in France who benefit from support by     health insurance : 3C100 knee C-leg (Otto Bock HealthCare, Duderstadt, Germany), the Rheo     Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360 (Proteor, Saint Apollinaire, France).     These prostheses have the common feature of being equipped with a single-axis prosthetic     knee, controlled by a microprocessor, wich allows to adapt instantly to the user's walking     speed changes. They are indicated in the proximal amputations of the lower limbs from knee     disarticulation included. Their prescription can only be made by a doctor of Physical     Medicine and Rehabilitation. These prostheses are subject to four criteria attribution and     reimbursement by the List of Products and Services Refundable (LPPR = Liste des Produits et     Prestations Remboursables). This criteria are the ability to: have a walking speed greater     than or equal to 4 km/h, walk 2km continuous, descend an inclined slop of 15% and to walk     down the stairs step by step. These criteria must be validated after a minimum trial period     of 15 days.      These attribution criteria raise the question today of how they are measured, no     recommendation defining this procedure. While many standardized assessment tests of different     gait parameters are available and used in clinical research, the attribution criteria are not     being built in reference to these tests.      The overall objective of the study is to evaluate the diagnostic value of two simple clinical     tests, the 2 and 6 minutes walk tests, to assess functional performance in patients with     transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).   "
39669|NCT02766374|"     The goal of this research study to see whether biofeedback therapy helps treat asthma, and if     so, how it works. Biofeedback is a treatment method that can teach how to bodily control.     Biofeedback is widely used to help people relax. In this study however, the investigators     want to learn if a specific type of biofeedback actually improves asthma in a way that might     allow the reduction or elimination of other controller treatments like     inhaled-corticosteroids.   "
39694|NCT02766049|"     The aim of this study was to assess tolerability and safety of three different formulations     of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV     chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with     HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable     impact was also assessed.   "
39670|NCT02766361|"     The study consists of a clinical trial comparing a new structured group intervention,     denominated Cognitive-Behavioral Rehabilitation, to treatment as usual (TAU) for bipolar     patients. The new approach is a combination of cognitive behavioral strategies and cognitive     rehabilitation exercises, consisting of twelve weekly group sessions of 90 minutes each. To     be included in the study, patients must be diagnosed with bipolar disorder, type I or II, be     18 to 55 years old, in full or partial remission and have an IQ of at least 80. A     comprehensive neuropsychological battery, followed by mood, social functioning and quality of     life assessments will occur in three moments: pre and post-intervention and after 12 months.   "
39671|NCT02766348|"     Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will     receive only chemotherapy.   "
39672|NCT02766335|"     This phase II trial studies how well anti-B7H1 monoclonal antibody MEDI4736 (MEDI4736) works     in treating patients with stage IV squamous cell lung cancer that has come back after     previous treatment. This is a non-match sub-study that includes all screened patients not     eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as MEDI4736, may be     able to shrink tumors. MEDI4736 may be effective in treating patients with squamous cell lung     cancer.   "
39673|NCT02766322|"     The investigators wish to study the effects of alcohol on three forms of bariatric surgery,     Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and laparoscopic adjustable gastric     banding (LAGB). The surgery is not part of the clinical trial. If insurance does not cover     the procedure, then the patient is responsible for payment of the surgical process. The     investigators are doing pre and post surgery testing to provide a better understanding of the     effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and     elimination from the body, 2) the effects of alcohol on mood, and 3) the effects of alcohol     on driving.   "
39674|NCT02766309|"     This study aims to examine the relation between health status and self-assessment of health     condition, their relation to healthcare services utilization, and also to identify the     profile of those who assess their health condition as mediocre to poor in general population     and according to nationality.   "
39675|NCT02766296|"     PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause     significant distress and impairment to the affected individuals. The current project aims to     examine whether computerized emotional working memory training (eWMT) can help improve     working memory capabilities and reduce trauma-related emotional symptoms among individuals     with elevated trauma-related symptoms. Participants will be randomly assigned to one of the     two computerized training programs. At baseline, post-training, and 1-month follow-up,     participants will be assessed with respect to their emotional symptoms and working     memory-related cognitive performance. Pending successful outcomes, this study will provide     important knowledge that will guide the future efforts to develop an effective, accessible,     and cost-efficient intervention program.   "
39676|NCT02766283|"     To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in     pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice     setting.   "
39737|NCT02765490|"     The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12),     safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335,     odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected     subjects without cirrhosis.   "
39678|NCT02766257|"     Long surgical wait-times and limited hospital capacity are common obstacles to surgical care     in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to     these problems. The aim is to study the introduction of ambulatory surgery in a pediatric     hospital in SSA.      This is a cross-sectional descriptive study which took place over 6 months. It includes all     the patients assigned to ambulatory surgery in the Pediatric University Hospital in     Ouagadougou, Burkina Faso.   "
39679|NCT02766244|"     Three patients were recruited for assessment of ICG fluorescence in burns.   "
39680|NCT02766231|"     Type & Design:      Post-market, international, multicentre Prospective, parallel groups, open-label, baseline     controlled      Objectives:        1. Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS          designs        2. Incidence of adverse events and identification of possible risk factors for          unsatisfactory results        3. Mid-term survivorship of the implants   "
39681|NCT02766218|"     The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with     mother-toddler dyads who participated in a study that is testing the effects of a     multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain     in obese women. Specifically, dyads will be invited to participate in home-based assessments     to videotape an evening meal, have anthropometric measures taken, and complete study     questionnaires. The overall goal is to understand factors related prospectively to responsive     feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18     and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which     factors are most strongly predictive of child zBMI change from birth to 36 months.   "
39682|NCT02766205|"     The aim of the proposed study is to identify predictors of covert atrial fibrillation (AF) in     Embolic Stroke of Undetermined Source (ESUS) patients and develop a prognostic score for the     identification of covert AF in this population.   "
39690|NCT02766101|"     The purpose of this study is to examine whether an exergaming, aerobic physical education     (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and     classroom functioning among children with behavioral health challenges attending a     therapeutic day school. After following an approved consent/assent process, children     attending the school were randomized by classroom to take part in either 7 weeks of the     experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout     period, children then crossed over into the other arm.   "
39691|NCT02766088|"     The purpose of this study is to describe the burden of DENV illness among household members     aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.   "
39683|NCT02766192|"     Background: The poor prognosis and public health burden of PTSD necessitates the development     of more effective and broader treatment approaches. In the etiopathogenesis of PTSD, trauma     memories become ingrained into key brain areas through conditioned learning and are triggered     by various situations of daily life. The brain glutamate system plays a key role in the     process of trauma learning and trauma memories via long-term potentiation. Ketamine     administration modulates the glutamate system and has been used in the treatment of     depression and PTSD. Previous studies demonstrate that a single low dose of ketamine rapidly     improves symptoms of refractory PTSD and treatment resistant depression. Unfortunately the     observed response is short-lived (4-7 days, maximum up to 2 weeks) and multiple doses often     produce unacceptable side effects. TIMBER (Trauma Interventions using Mindfulness Based     Extinction and Reconsolidation for trauma memory) psychotherapy, is a manualized and     translational mindfulness based cognitive behavioral therapy specifically designed to target     trauma memories and their expressions in PTSD patients. The placebo controlled pilot study     examined the efficacy of a protocol combining a single infusion of low dose ketamine     (0.5mg/kg) and TIMBER psychotherapy in subjects suffering from chronic PTSD. The objective of     this pilot study was to optimize and individualize treatment of chronic PTSD using a rapid,     effective, trauma specific, user friendly and inexpensive approach that uses cutting edge     psychopharmacological combined with novel psychotherapeutic approaches.      Methodology: The randomized, double blind, placebo-controlled pilot study used a crossover     design. Ten subjects with refractory PTSD were assigned to one of two arms: one arm (n=5)     received combined ketamine infusion and TIMBER therapy (TIMBER-K arm) and the second (n=5)     received combined placebo (normal saline) infusion and TIMBER therapy (TIMBER-P arm). All 10     subjects received a short version of TIMBER therapy after 10 minutes of onset of the infusion     in which reactivation of trauma memories was initiated in a controlled manner using     standardized scales and scripted narrative of the index trauma. This was followed by a     standardized mindfulness based cognitive therapy module to quickly de-escalate the arousal     symptoms followed by induction of detached observation and reappraisal of the trauma     experience. After completion of the 40-min infusion, all subjects were trained on the full     version of TIMBER therapy using methods of mindfulness based graded exposure therapy and a     twice-daily schedule of home practice was initiated. The investigators are currently in a     process of recruiting fifty more subjects to examine the effects in a larger sample.   "
39684|NCT02766179|"     The objectives of this study is to compare short-term outcomes of CPAP and Adjustable     thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a     randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary     outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ     ESS, and AHI or RDI, respectively.   "
39685|NCT02766166|"     CHAOS is based on the investigator's new and exciting results from pre-clinical and large     longitudinal multi-center observational clinical studies of critically ill patients and     asymptomatic community-based adults with little or no advanced disease.      By integrating approaches from the physical, biological, computational, statistical and     clinical sciences, this observational study will test the hypothesis that early diagnosis of     subclinical signatures of critical illness encoded within physiological signals complements     conventional clinical predictors by providing unique prognostic insight.      The primary goal is to reduce mortality, morbidity and complications by early identification     of individuals with brewing subclinical critical illness and adverse events before overt     clinical presentation (e.g., cardiac arrest, arrhythmias, hemorrhage, respiratory failure,     circulatory collapse). This will provide the necessary lead time for healthcare providers to     deliver early, more effective and/or preventive therapies. Through innovative approaches,     CHAOS also meets the challenge of medical errors to reduce missed diagnosis, misdiagnosis,     preventable harm and variability in provider adherence to best practice guidelines.      The goal is to validate predictive algorithms and identify subclinical signatures of illness,     ranging from asymptomatic adults in the community to very sick patients in the hospital. The     overall goal is to make healthcare more precise, effective, efficient, safe and timely while     reducing costs, preventable harms and adverse events.   "
39746|NCT02765373|"     This study is a prospective, controlled phase IV clinical trial among postmenopausal patients     with hormone receptor-positive breast cancer.The main purpose is to compare the effects of     steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of     breast cancer patients.   "
49657|NCT02635672|"     Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and     recommended phase 2 dose (RP2D) of BAY 1251152 in patients with solid tumors and aggressive     non-hodgkin's lymphoma (NHL).   "
39686|NCT02766153|"     Myeloproliferative disorders (MPD) include chronic myeloid leukemia (CML) (Ph +) and     essential thrombocythemia (ET), the polycythemia vera (PV), myelofibrosis (MF) called SMP Ph.     CML is the ultimate model of carcinogenesis. SMP is a characterized by a malignant monoclonal     proliferation of a pluripotent hematopoietic progenitor determined by the presence of a     balanced translocation between chromosomes 9 and 22 (Ph chromosome) which leads to major     changes of a large number of cell functions. Investigators now believe that within the bone     marrow exist two types of hematopoietic niches' niche osteoblastic / endosteal and vascular     niche, controlling the maintenance and differentiation of hematopoietic stem cell pool. The     endosteal niche, is a hypoxic region near the endosteal trabecular, which provides protection     to deeply dormant stem cells. Data from the literature suggest that in the SMP, especially     CML, the interaction of malignant stem cells with the microenvironment niche Endosteal could     favor their survival and resistance to treatment. The therapeutic management of CML was upset     by the use of tyrosine kinase inhibitors (TKIs). However, despite these advances, even in     situations of undetectable residual disease, it has been observed relapses of the disease     stopped TKI leaving suggest that there is a resistance of leukemic stem cell to TKI.      Work in the group Bipoa Bio Engineering and Pathophysiology Osteo-Articular helped develop     a 3D model of ex vivo bone formation, which can mimic the endosteal niche. the goal is to     apply this model to the SMP of hematopoiesis by referring to normal hematopoiesis. it will be     tested the hypothesis that the endosteal ex vivo recess of the 3D modeling allows to     highlight a special interaction can promote the persistence of the leukemia stem cell despite     the use of effective therapies.   "
39687|NCT02766140|"     The present trial will be performed to evaluate whether SHR1020 in combination with docetaxel     in patients with Local Advanced or Metastatic or recurrent Non Squamous NSCLC is more     effective as compared to placebo in combination with docetaxel. A secondary aim is to obtain     safety information as well as information on quality of life of patients treated with SHR1020     in combination with docetaxel.   "
39688|NCT02766127|"     Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering     material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic     due to radiotherapy for head and neck cancer.      Methods: A total of 17 patients were selected for the study. The study was conducted as a     split-mouth randomized clinical trial comparing: 1) VF 2) Universal Dentin Sealant (UDS), 3)     Clearfil Protect Bond (CPB) and 4) Flor-Opal® Varnish (FOV). Basal and stimulated salivary     flow was recorded for each patient according to the method described by Sreebny. The pain     experience was generated by a cold stimulus directly to a sensitive tooth surface and     assessed using the Visual Analogue Scale (VAS). The response was recorded before the     application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks     (POST-3) and 12-week controls (POST-4).   "
39689|NCT02766114|"     Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm     length.   "
39695|NCT02766036|"     The aim of this study is to determine the impact of Propolis on proteinuria reduction and     protection of the glomerular filtration rate in chronic renal failure patients.   "
39696|NCT02766023|"     This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that,     following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel,     Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week     incidence of BV recurrence when compared to placebo. The primary objectives of this study     are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as     compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with     MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by     comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.   "
39697|NCT02766010|"     1. Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring          Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH,          Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium,          Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine,          Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac          index, stoke volume and blood gases compared with the simultaneous results from hospital          references device (when available)        2. Hypothesis- Human physiological biomarkers may be measured from the color distribution          of the internal or external (skin) tissue. The technology of the TensorTip device is          based on the color distribution of the peripheral blood tissue, which enables the          measurement of certain biomarkers and vital signs under consideration   "
39698|NCT02765997|"     This is an open label, interventional, randomized phase II trial comparing StemRegenin-1     (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood     (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1     randomization will be employed with a higher chance of being assigned to the experimental     arm.   "
39699|NCT02765984|"     Trans vaginal ultrasound with a partially full bladder will be done at gestational age     earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial     cavity and the distance between the implantation site and the internal cervical os . Doppler     assessment of the retrochorionic blood flow at the area behind the maximum chorionic tissue     to detect resistance index.   "
39700|NCT02765971|"     540 consented women for being enrolled in this clinical trial and candidates for elective     cesarean section will be divided into 3 groups:        -  Group A, 180 women will receive sugarless gum after their operating room discharge by 3          hours for at least half an hour at two hours interval.        -  Group B, 180 women will receive laxatives after their operating room discharge by 3          hours.        -  Group C, 180 women as control group, they will not receive neither gum nor oral fluids.          They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds          .   "
39724|NCT02765659|"     This implementation study is testing whether community members can use a 3-step model     (prepare, roll-out and sustain) to implement an efficacious peer group HIV prevention     intervention with fidelity and effectiveness in a single district in Southern Malawi. A     collaborative partnership including university researchers and district government, health     system and traditional leaders will support community volunteers in implementation. Both the     implementation process and the effectiveness of the intervention when implemented by     communities will be evaluated.   "
39701|NCT02765958|"     Sleep is a fundamental need for human and is associated with the working performance and the     disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased     largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more     important recently. In clinical settings, the analysis of daily sleep quality depends on     actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really     convenient for patients. In this trial, the investigators will measure the subjects' ECG     signal and movement using a portable ECG device with motion sensor. On the other hand, the     sleep stages are also obtained from the current wide-established measurement-     polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our     algorithm of artificial neural network. Then, the investigators can obtain the preliminary     analysis of sleep quality can be obtained by using ECG device with our algorithm. It is     helpful for doctors to realize the patent's sleep quality quickly   "
39702|NCT02765945|"     This is the second phase of a study designed to determine the immunological effects of     long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis     (phase 2). The results indicate that six months of moderate intensity exercise reduces bone     resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral blood     mononuclear cells.   "
39703|NCT02765932|"     This is a prospective study looking at the impact of psychosensory therapy and how it can     diminish pain and consumption of pain medications. The primary study objective is to evaluate     the change in Visual Analogue Score (VAS) score assessing for pain from Baseline, every day     of inpatient stay, 7 days after leaving hospital (via phone), and 3 months post-op(via phone)     and to correlate the psychosensory therapy and overall use of pain medications/narcotics.   "
39704|NCT02765919|"     The purpose of this study is to compare two diffrent brachytherapy treatment option in     locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is     effective in locoregional control and more convenient in terms of cost and time than 7 Gy     brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.   "
39705|NCT02765906|"     Preeclampsia is a life-threatening condition unique to pregnancy which occurs in 5-8% of all     pregnancies. It contributes to a large proportion of maternal mortality worldwide and these     deaths largely result from delayed diagnosis.      A number of studies have shown that patient knowledge about preeclampsia is poor and that     patient education can improve patient awareness. The investigators would like to find out     what type of patient education is most effective. The investigators propose a three arm     randomized controlled trial (RCT) where the first arm will receive a graphic card depicting     signs and symptoms of preeclampsia, the second arm will watch an educational video on     preeclampsia, and the third arm will have no visual form of patient education; they will be     exposed only to the counseling they receive with their routine prenatal care. The card and     video were both developed by the Preeclampsia Foundation and in a prior RCT the card was     shown to be a useful educational intervention. This study would expand on this previous data     by comparing the graphic card to an informational video available on the Preeclampsia     Foundation's website     (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant     -woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an     educational tool. Patients in the arm receiving the graphic card for educational intervention     will be allowed to keep this card. Primiparous patients seen in the ambulatory prenatal     clinic and Maternal Fetal Medicine (MFM) clinic will be enrolled at 18w0d-24w6d gestation. At     the time of enrollment baseline preeclampsia knowledge, demographics, and patient anxiety     before and after initial exposure to the educational interventions will be assessed. A follow     up assessment of knowledge of preeclampsia will be obtained at 32-36 weeks gestation to     measure retention of knowledge. Patient medical records will be reviewed for delivery     outcomes which will be recorded and compared.   "
39706|NCT02765893|"     This is a prospective, comparative randomized study. Our study population includes women with     pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy.      The two groups will include the study group, who will have their Foley catheter removed 6     hours post-op, and the control group who will have an indwelling Foley catheter overnight.     The two groups will be assigned according REDCap randomization system.   "
39709|NCT02765854|"     This randomized phase II trial studies how well ixazomib and dexamethasone or ixazomib,     dexamethasone, and lenalidomide work based on the presence of the rearrangement of a gene     called nuclear factor of kappa light polypeptide gene enhancer in B-cells 2 (NFKB2) in     treating patients with multiple myeloma that has returned after a period of improvement or     does not respond to treatment. Ixazomib may stop the growth of cancer cells by blocking     enzymes called proteasomes needed for cell growth. Drugs used in chemotherapy, such as     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide     may stimulate the immune system against cancer cells and may also prevent the growth of new     blood vessels that tumors need to grow. It is not yet known whether ixazomib and     dexamethasone, or ixazomib, dexamethasone, and lenalidomide are more effective in treating     multiple myeloma.   "
39710|NCT02765841|"     This is a Phase 3 single-arm, open-label, international, multi-center clinical trial to     evaluate the efficacy and safety of lomitapide in pediatric patients with HoFH who are     receiving stable lipid-lowering therapy, including LDL apheresis. The study is comprised of a     12-week Run-in Period, a primary 24-week Efficacy Phase, followed by an 80-week Safety Phase.   "
39711|NCT02765828|"     This purpose of this study is to determine if tongue strength and tongue ultrasound     measurements differentiates patients with untreated late-onset Pompe Disease (LOPD) from     patients with acquires/hereditary myopathies or neuropathies. It is hypothesized that     abnormalities in tongue function and structure in patients with LOPD may be useful in     discriminating this condition from others that have similar presentations.   "
39712|NCT02765815|"     This is a prospective, single-center, single-blinded, randomized, case-control study. The     study is conducted by a single investigator at an orthopedic surgery institute, with a     minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared     with the surgeon's standard method (detailed below) for pain management intraoperatively.   "
39725|NCT02765646|"     The objective of this study is to demonstrate the clinical performance of the Tryton Side     Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to     treat de novo bifurcated lesions involving both the Left Main (LM) and Circumflex Coronary     Artery(LCX).   "
39726|NCT02765633|"     The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal     participants at risk of thrombosis.   "
39772|NCT02765035|"     The aim of this post-market study is to confirm that the microprocessor controlled prosthetic     knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring     additional benefit to the users primarily on level walking and secondarily in safety, stair     and hill mobility, activities of daily living, satisfaction and preference.   "
39713|NCT02765802|"     Lambda is the pegylated form of interferon lambda-1a (IFN-λ), a conjugate of recombinant     human interleukin 29 (rIL-29) and a linear polyethylene glycol (PEG) chain. IFN-λ and     interferon alpha (IFN-α) share the common interferon (IFN)-stimulated gene induction pathway     that leads to broad-spectrum antiviral activities. Since IFN-α has demonstrated     anti-hepatitis delta virus (HDV) activity in patients with chronic hepatitis delta (CHD), it     is postulated that pegylated IFN-λ could also induce HDV ribonucleic acid (RNA) decline in     patients with CHD. Based on IFN-λ's more limited receptor distribution and previous data from     studies involving treatment with IFN-λ in patients with hepatitis B virus (HBV) or hepatitis     C virus (HCV), it is postulated that Lambda treatment could be associated with fewer adverse     effects than IFN-α treatment. This Phase II study is designed as randomized, open-label study     of Lambda 120 or 180 μg subcutaneous (SC) injection weekly for 48 weeks in patients with     chronic HDV infection, and the primary objectives of the study are as follows:        -  To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a          48-week treatment period.        -  To evaluate the effect of treatment with 2 different doses of Lambda on HDV RNA levels.   "
39714|NCT02765789|"     Anti-glomerular basement membrane (GBM) glomerulonephritis is a rare autoimmune disease     mediated by anti-GBM antibodies and characterized by acute renal failure due to diffuse     crescentic glomerulonephritis. Established treatment is cyclophosphamide and corticosteroids     to suppress anti-GBM production and daily plasma exchange to remove circulating anti-GBM     antibodies. The vast majority of patients with anti-GBM glomerulonephritis develop     irreversible end-stage renal failure despite this treatment. Immunoadsorption may lower     anti-GBM titres more effectively than plasma exchange. The goal of this interventional open,     non-randomized pilot study is to study the efficacy, adverse events, logistic feasibility and     costs of immuno-adsorption for the removal of anti-GBM antibodies in patients with acute     renal failure due to anti-GBM glomerulonephritis. Eight patients with acute renal failure due     to anti-GBM glomerulonephritis with or without accompanying pulmonary involvement will be     treated with daily immunoadsorption, instead of plasma exchange, until anti-GBM titres are     undetectable. All other aspects of the treatment (e.g. immunosuppressive treatment, renal     replacement therapy) will be standard. The primary study parameter is the number of days that     anti-GBM antibody titre is above a toxic level, defined as >30 ELISA units. Secondary study     parameters are the tolerability and adverse events of immunoadsorption, the logistic     feasibility defined as the time interval between diagnosis and start of first     immunoadsorption treatment and costs of immunoadsorption.   "
39715|NCT02765776|"     RAL is considered one of the better-tolerated antiretroviral medications, due to limited side     effects and few long-term safety concerns. Five-year clinical trial outcomes and clinical     experience have demonstrated durable virologic suppression in both treatment-naïve and     treatment-experienced patients, including patients with extensive antiretroviral history and     documented antiretroviral resistance. Studies have also exhibited low adverse effect rates     and reliable long-term safety lending to improved tolerance. Several trials have evaluated     the reduction in adverse effects in patients switched from various antiretroviral agents to     RAL. Treatment-naïve studies have demonstrated a lipid-neutral effect in patients on     RAL-containing regimens. When transitioning patients from a ritonavir-boosted PI regimen,     statistically significant decreases in total plasma cholesterol, low-density lipoprotein, and     triglycerides were demonstrated. Given its negligible interaction with the cytochrome P450     system, RAL displays minimal drug-drug interactions, making it a good option for ageing     patients on multiple medications.      This is an observational retrospective cohort in real world to describe RAL data, including     NUC-sparing regimens, in aged HIV patients. It is a phase IV study. 90 patients will be     enrolled from the Department of Public Health and Infectious Diseases of Sapienza     University of Rome. More than 4000 HIV patients are followed at this Department of Public     Health and Infectious Diseases of Sapienza University of Rome. More than 50% of these     patients are ≥ 50 years. From 10 to 12% are treated with a raltegravir based- regimen.      The primary endpoint will be the description of the proportion of participants with an HIV-1     viral load < 50 copies/mL.      The secondary endpoints will be:        -  Change from Baseline in CD4+ T-cell counts, CD8 cell counts, CD4/ CD8 ratio        -  Proportion of subjects with laboratory alterations        -  Proportion of patients with adverse events (AE), serious adverse events (SAE), also          according to their severity   "
39716|NCT02765763|"     This is a placebo-controlled blinded clinical evaluation of day and night skin care creams     supplemented by Medicell Technology's composition of defensins and supportive molecules     determine the skin hydration and anti-aging properties of the topical test articles after     repeated application to the skin of human subjects.   "
39717|NCT02765750|"     The patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. Group     A and B patients will listen to a positive message under general anesthesia. Group C patients     will not listen to the message. The postoperative pain, analgesic consumption and frequency     of nausea, vomiting and emergence agitation episodes will be documented and compared between     the 3 groups.   "
39721|NCT02765698|"     The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission     Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about     specific sites in the body that the endometrial cancer may be present. If the PET/MRI is     accurate and successful in providing this information, then women in the future may be able     to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.   "
39722|NCT02765685|"     This is a biomedical study on a medical device. 120 patients will participate in this study     and will be split into 2 groups:        -  60 patients in the usual care group: these patients will receive the usual care          proposed by their doctor for 12 months.        -  60 patients in the ODRA group: these patients will wear the ODRA brace for 12 months          in addition to their usual care. They will be instructed to wear the brace for at least          6 hours per day, 5 days per week and to take it off during rest periods when lying down.      The distribution of patients in the groups will be randomized. For this study, patients will     be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months     and 12 months.   "
39723|NCT02765672|"     The main objective of this study is to discern if an Occupational Therapy Driving     Intervention (OT-DI) improves fitness to drive abilities of Combat Veterans and also     investigate if results leads to reduced driving errors on the driving simulator and an     on-road test. The driving behavior of 260 Combat Veterans will be studied on a driving     simulator at baseline after which they will be randomized into control and intervention     groups. The intervention group will receive sessions of Occupational Therapy Driving     Intervention by a trained driving rehabilitation specialist. The control group on the other     hand will receive driving safety education sessions by a driving safety professional. Both     groups will be evaluated for driving performance on the driving simulator to ascertain     whether there have been changes in the number of driving errors at two and three months upon     enrollment. Caregiver responses on driving behavior of Combat Veteran and public driving     records from The Department of Motor Vehicles will be analyzed to for changes in number of     driving errors.   "
39727|NCT02765620|"     Chemo-radiotherapy and targeted therapy are widely used as non-surgical treatments for solid     tumors. Early assessment of treatment response is considered efficient and helpful to     clinical management and personalized therapy.RECIST 1.1 criteria was accepted widely.     Complete response (CR), partial response (PR), stable disease (SD), and progressive disease     (PD) are defined in the RECIST criteria. This type of classification divides intrinsically     continuous data (tumor size) into 4 bins, losing statistical power for ease of nomenclature     and convenience. The 18F-FDG PET exam is based on metabolic information and considered to     overcome limitations of anatomic imaging and more suitable for assessment of therapeutic     response.PERCIST 1.0 proposes a series of detailed and unambiguous regulations about     standardization procedures to ensure the reproducibility. Complete metabolic response (CMR),     partial metabolic response (PMR), stable metabolic disease (SMD), and progressive metabolic     disease (PMD) are defined in the PERCIST criteria.      So far, there have several studies using metabolic-based PERCIST criteria in patients with     solid tumors, including lung cancer, digestive tumor and lymphoma, etc. But all of these     studies had limitations of small study sample, thus were need to be further investigated.     Compared to RECIST, the advantages of PERCIST were to evaluate chemotherapy, especially     targeted therapy, to distinguish PMR and SMD patients from SD group in RECIST, and to better     predict the response rate. Recently, several studies applied PERCIST criteria to evaluate     neoadjuvant chemotherapy in pancreatic cancer and rectal cancer, and revealed the metabolic     response results were well related to pathology. All these studies conclude PERCIST criteria     could help making clinical therapeutic decisions. Moreover, several studies have shown that     PERCIST has advantage in predicting early response of several malignant tumors.      The aim of this multicenter study is 1) to evaluate treatment response in newly diagnosed and     pre-therapeutic patients with solid tumors who are going to receive a baseline , an early     follow-up (after a certain period of treatment cycle) and a final (after treatment) 18F-FDG     PET/CT; 2) to compared PERCIST criteria to RECIST 1.1 criteria in prediction treatment     response, especially in early stage of treatment; 3) to reveal the value of PERCIST criteria     in clinical therapeutic management and tailed therapy.   "
39728|NCT02765607|"     In this observational study investigators examine the presence of circulatory oscillations in     blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.   "
39729|NCT02765594|"     Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the     world.There is to date no curative therapy for patients with IgAN.It is considered that     dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and     interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in     the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable     impact on immune activation by the reduction of circulating activated immune cells that     including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells,     reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha.     Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard     the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the     potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect     effect. This will be a single center, prospective, randomized, controlled study to assess the     utility of hydroxychloroquine in IgAN patients.   "
39730|NCT02765581|"     The purpose of this study is to evaluate the efficacy of verum acupuncture (VA) for the     prevention of migraine without aura compared to non-penetrating sham acupuncture (SA) and     usual care alone (UC). This study also aims to determine whether the intensity of deqi     sensations and psychosocial factors (including patient expectations, patient personality     traits, patient-doctor relationship, traditional Chinese medicine constitution, depression,     anxiety, sleep quality, etc.) are associated with clinical outcomes.   "
39831|NCT02764333|"     This is a Phase 2 clinical trial, which tests two investigational drugs: TPIV200/huFR-1 (also     called TPIV200), which is a vaccine consisting of proteins from the folate receptor alpha     mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help un-block     parts of the immune system. The aim of this study is to find out whether these drugs, when     given together are safe, and whether they are effective in treating cancer.   "
39731|NCT02765568|"     Coronary revascularization improves survival for patients with coronary artery disease.     However,many patients are left with poor physical and mental health. Traditional cardiac     rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to     traditional cardiac rehabilitation programming may however provide superior understudied     benefits to patients with poor physical and mental health. Nordic walking (NW) and     high-intensity interval training (HIIT) are two examples of alternative programs for cardiac     rehabilitation, which may provide superior physical and mental health benefits when compared     to traditional MICE. The main purpose of this project is, therefore, to determine the short     and long term physical and mental health benefits of alternative cardiac rehabilitation     modalities, including NW and HIIT on exercise capacity, quality of life and depression after     a 12-week program.   "
39732|NCT02765555|"     The purpose of this study is to assess the safety, tolerability and PK profile of a single     dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than     risperidone.   "
39733|NCT02765542|"     The purpose of the study is to evaluate the feasibility and potential impact of an automated     phone system in monitoring and improving self-care and health outcomes among patients with     depression in Bolivia.   "
39734|NCT02765529|"     Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been     reported in part due to the rising in life expectancy. For instance, exposure to air     pollution, and in particularly to fine particles has been classified by the International     Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly     population particularly sensitive. However, no validated biomarkers have been identified to     assess the exposure to fine particles maybe correlated to cancerogenesis.      AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution     exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses     of fine particles.      Secondly, the study aims to analyze, according to age, the leukocytes response to the urban     pollution exposure.   "
39735|NCT02765516|"     The objective of this study is to utilize information on associations between genetic     predisposition pertaining to multiple single nucleotide polymorphisms (SNPs) and the degree     of responsiveness of low-density lipoprotein cholesterol (LDL-C) lowering to plant sterols     (PS). The predictive potential of SNPs associated with PS responsiveness will be evaluated     using a randomized human intervention trial examining responsiveness of lowering blood LDL-C     levels to PS intervention.   "
39736|NCT02765503|"     The aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of     accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy     delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous     cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus,     nasopharyngeal and stage I-II glottic carcinomas.   "
49677|NCT02635412|"     This is a randomized controlled trial to investigate the optimal timing of delivery in     clinically stable women with a suspected morbidly adherent placenta.   "
39738|NCT02765477|"     The number of patients with cardiovascular implantable electronic devices (CIED), including     ventricular pacemakers, continues to increase. However, there are no accurate     electrocardiographic (ECG) criteria to diagnose acute myocardial infarction (AMI), even if     due to acute coronary occlusion (ACO), with a ventricular pacemaker in situ. In this     retrospective, multicenter, case-control study the investigators will examine ECG criteria to     diagnose ACO in patients with ventricular paced rhythms. During this process, the     investigators will also create a database from which investigators will be able to answer     multiple additional questions on this population of patients.   "
39739|NCT02765464|"     Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly     increase mortality, length of stay, and costs, however detection has proven difficult as     markers like elevated creatinine and decreased urine output may take days to manifest and are     late indicators of AKI. The combination of two urinary biomarkers, Tissue Inhibitor of     Metalloproteinase 2 (TIMP-2) and Insulin-like Growth Factor Binding Protein 7 (IGFBP-7), has     been shown to increase within 12 hours following renal insult, allowing assessment of risk     for developing acute kidney injury. Therefore, the investigators plan to assess if acute     kidney injury in critically ill trauma patients can be determined earlier using urinary     TIMP-2 and IGFBP-7 via the NephroCheck testing system. These markers have not been     specifically evaluated in trauma patients at risk of AKI.   "
39740|NCT02765451|"     This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of     clinical research in non-academic health institution. The randomization, in open     label,determines the duration of the interventions. Half of participants will receive the     interventions during 2 years, while the other half during 1 year.   "
39741|NCT02765438|"     Balance disorders are sometimes treated with exercises performed on unbalanced surfaces. The     BOBO system allows connection of a standing platform attached to any of these surfaces, to     a screen, where the user can control games with his or her body movements. In this study, the     lower limb muscle activity of healthy individuals will be monitored during different games in     order to assert the the ability of each game in strengthening certain muscle groups.   "
39752|NCT02765295|"     This is a multi-center, randomized, double-blind, parallel-group trial. After a 2-week run-in     period, eligible patients will be, based on the randomization codes kept in sealed envelopes,     randomly assigned to receive usual care (mucolytics and/or chest physiotherapy) plus oxygen     inahaltion (1 hr daily for 12 consecutive months) or hydrogen inhalation (1 hr daily for 12     consecutive months) provided by the sponsor. At 3 months after the end-of-treatment, a     follow-up visit will be scheduled for all patients.   "
39753|NCT02765282|"     Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician     per standard care.   "
39754|NCT02765269|"     The purpose of this study is to determine whether the Intelligent Pain Management System     (IPMS) could make recording and interfering pain timely among cancer patients with pain. The     system's usability, feasibility, compliance, and satisfaction will also be assessed.   "
39755|NCT02765256|"     To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage     and antibiotics with or without an antifungal) in the management of active Crohn's Disease     (CD) that is refractory to conventional, immunosuppressive therapy.   "
39742|NCT02765425|"     The research objective of this study is to determine whether an intervention and associated     robotic device called Assisted Movement with Enhanced Sensation (AMES) can be used to     enhance balance recovery following an unexpected loss of balance by conditioning areas of the     brain involved in lower-limb (LL) motor control. It is hypothesized that AMES can improve     balance recovery, gait, and reduce falls in near-frail elderly people by improving LL     strength, speed, and coordination.      AMES, is a medical intervention and robotic device originally developed to aid patients'     recovery from injuries to the central nervous system that limit movement. Earlier published     studies demonstrated a unique property of AMES, namely that it is capable of reducing     sensorimotor impairment in the severely impaired, an underserved population of patients with     brain and spinal cord injuries. AMES applies assisted movement, biofeedback, and sensory     stimulation simultaneously and non-invasively to the upper or lower limb, the initial intent     being to address impairments such as weakness, spasticity, sensory loss, and dyssynergia     (i.e., co-contraction). These reductions in impairment are achieved through cortical     plasticity. In the present study, the same methodology will be applied to the lower limbs of     the near-frail elderly to reduce falls by training faster reaction times, stronger reactions,     and more coordinated recoveries from slips and trips   "
39743|NCT02765412|"     The overall goal of this project is to test two strategies for implementing a shared decision     making tool to be used by providers while talking to patients about lung cancer screening.     Eight participating sites will be randomized to compare standard implementation with     intensive implementation. The investigators will also determine the effect of allowing     providers to design their own risk threshold algorithms into a lung cancer screening decision     aid, Decision Precision. Additionally, the investigators will determine the factors that were     most important for successful implementation of the shared decision making tool. Finally, the     investigators will survey patients to evaluate the effects of Decision Precision on patient's     knowledge of the risks and benefits of lung cancer screening, the quality of their decision     making, and their satisfaction with care.   "
39744|NCT02765399|"     This study aims to evaluate the mechanisms underlying the effect of incretin therapy on     lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of     liraglutide on hepatic de novo lipogenesis.   "
39745|NCT02765386|"     When providing amplification post-implantation to residual acoustic hearing in the implanted     ear, the lower frequency boundary can be modified to minimize or avoid overlap between the     frequencies coded through acoustic hearing and those presented through electrical     stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of     modifying this parameter will be investigated in this study. To avoid the research being     confounded by prior bias for a particular frequency allocation, the study will be conducted     with newly implanted recipients.      This study will also investigate whether tests which measure the ability to use low frequency     hearing and objective measures can predict the preferred Fc and speech performance benefit.   "
39747|NCT02765360|"     Patients with severe respiratory diseases such as chronic obstructive pulmonary disease     (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive     ventilation (NIV). NIV consists of a machine (ventilator) that is blowing air inside a     patient's airway through a mask. NIV provides patients with a bigger breath. Bigger breaths     help patients to have a more oxygen and less waste gas (or carbon dioxide) in their body.      These changes can improve outcomes and quality of life. In order to provide appropriate     ventilation for each patient, the ventilator can generate different types of blowing:        -  Continuous positive airway pressure (CPAP) which delivers a constant flow of air through          the mask        -  Pressure support ventilation (PSV) which delivers a constant flow of air through the          mask and, on top of that, delivers more flow when the patient begins to inhale        -  Volume targeted ventilation which delivers a flow of air through the mask that is          adjusted breath by breath in order to achieve a preset volume.      These different type of blowing have consequences on patient comfort as well as on the     improvement of their ventilation.      To assess the improvement of the ventilation, currently blood tests are used, however, these     reflect overall output and may miss more subtle changes in breathing that could affect how     patients feel.      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of     sensors around the chest that provides information on how well the lungs are being filled     with air by the ventilator. It allows a non-invasive assessment of the effect of NIV on lung     ventilation in real-time.      The investigators hope to use the EIT technology to assess in real-time patients lung     ventilation when they are using the NIV. The investigators hope that EIT will provide     information on which type of blowing is more effective and more comfortable than the others.   "
39748|NCT02765347|"     The investigators intends to carry out a randomized, cross-over, prospective study which will     last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the     effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM     based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.   "
39749|NCT02765334|"     A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER)     system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute     and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to     chronic stroke patients.   "
39750|NCT02765321|"     This is a population-based natural experiment study aimed to examine the effect of a     multi-approach intervention focused on physical activity and healthy eating promotion to     individuals living in Jaguariuna city (São Paulo, Brazil).   "
39751|NCT02765308|"     Uveitis is a disease that affects over 2 million people around the globe, and can ultimately     lead to blindness. The proportion of patients with uveitis who become blind has not been     reduced over the past 30 years, and this is therefore an area that demands further research.     One of the major causes of blindness in uveitic patients is the development of uveitic     glaucoma, which occurs in 10-20% of uveitic eyes. This is likely to occur for reasons related     to the uveitis itself, but can also be caused as a side effect of the corticosteroids used to     treat uveitis. The raised IOP in uveitis is more difficult to treat than other types of     glaucoma.      To enable more effective treatment of uveitic glaucoma, the investigators need to understand     more clearly the mechanisms which underlie this process. The investigators therefore propose     a study to examine the contribution of altered aqueous dynamics to the development of raised     IOP in uveitis.   "
39756|NCT02765243|"     Patients with refractory and/or recurrent neuroblastoma have poor prognosis despite complex     multimodel therapy and therefore, novel approaches are urgently needed. The investigators are     attempt to treat this disease using T cells genetically modified with a 4th generation     lentiviral chimeric antigen receptor (CAR) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified     T cells can recognize and kill neuroblastoma through the recognition of GD2, a surface     protein expressed at high levels on neuroblastoma but not on normal tissues. This study will     evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory     and/or recurrent neuroblastoma.   "
39757|NCT02765230|"     The purpose of this cross-sectional study is to compare bilateral anterior segment     parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric     cataract extraction with primary IOL implantation to explore any possible interocular     differences and their possible relationships.   "
39758|NCT02765217|"     Recent studies showed that intestinal microbiota consist more than thousand bacteria, and     these microorganisms play the role as balance and continuity of the anatomical and functional     integrity gastrointestinal tract. Chronic diseases, nutritional factors, lifestyle factors     and medications including antibiotics changes the host microbiota in short or long-term     period. Antibiotics are the most commonly used drugs in pediatrics routine practice. Although     frequency and severity of side effects alter the choice of drug, mild complications may be     taken into consideration for treatment by a physician in the profit and loss balance. Our     study group (PROBAGE Working Group) have been recently showed that Lactobacillus reuteri DSM     17938 reduced the duration of diarrhea in children with acute infectious diarrhea, and are     safe and well-tolerated. In this study the investigators aim to evaluate the potential effect     of Lactobacillus reuteri DSM 17938 on the prevention of antibiotic associated diarrhea in     children.   "
39759|NCT02765204|"     The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell     glucagon release.   "
39760|NCT02765191|"     A study of renal blood flow and renal oxygenation measured by magnetic resonance after a     standardized fluid challenge and blood pressure elevation in critically ill, resuscitated,     septic patients.   "
39761|NCT02765178|"     Tourette syndrome is a complex neuropsychological disorder with both motor and vocal tics     associated with multiple psychological co-morbidities. Apathy has not been widely studied in     patients with Tourette syndrome. Apathy can result in decrease in self-care and disease     control. In this study investigators will compare the occurrence of apathy in the adolescent     Tourette syndrome population (at the UF center for movement disorders and Neurorestoration)     to an age and gender matched control population. Investigators will also assess the role of     commonly used medications in the Tourette population (neuroleptics and selective serotonin     receptor inhibitors) in the occurrence of apathy.   "
39762|NCT02765165|"     This is a multicenter, open-label, Phase 1/2, dose-escalation and dose expansion study of a     CXCR4 inhibitor, USL311, alone and in combination with lomustine in subjects with advanced     solid tumors (Phase 1) and subjects with relapsed/recurrent GBM (Phase 2). The study is     designed to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of     USL311 alone and in combination with lomustine.   "
39763|NCT02765152|"     The purpose of this study is to verify the additional effects of rhythmic specific training,     discrete specific training additional to conventional therapy on the upper limb after chronic     stroke subjects on the outcomes: motor control and functionality.   "
39764|NCT02765139|"     The objective of the study is to evaluate the impact of Engaging Men in Accountable Practice     (EMAP) on the prevention of violence against women and girls in North and South Kivu (DRC).     The study is conducted jointly by the World Bank's Africa Gender Innovation Lab and the     International Rescue Committee (IRC). EMAP is a program developed and implemented by the IRC     to engage men to reflect on how to reduce and prevent intimate partner violence through 16     weekly group discussion sessions. The study is a cluster randomized control trial in which     two groups of 25 self-selected men in 15 communities receive the EMAP intervention while in     15 other communities, 50 self-selected men receive an alternative intervention. Key outcomes     examined include: (i) Experience of past year physical, sexual and psychological violence     reported by women whose partners are EMAP participants; (ii) Participant's gender attitudes     and behaviors, conflict and hostility management skills; (iii) Power sharing and     communication within the couple.   "
39765|NCT02765126|"     Vaccines can have non-targeted or heterologous (also called non-specific) immunological     effects on the immune system i.e. effects other than inducing an immune response against the     disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological     effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal     influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult     control subjects (30-50 years).   "
39766|NCT02765113|"     1. Background: Blepharospasm refers to orbital and periorbital orbicularis muscle          spontaneous spasmodic contraction. Continuous spasm can be long or short, the          performance of non spasm will strongly closed repeatedly. At present, the pathogenesis          of blepharospasm is not clear, in addition, there is no particularly effective          treatment.        2. Purpose：compare two different surgical methods, observe the improvement of symptoms and          prognosis of patients with blepharospasm.        3. Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but          clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open          difficulties and the symptoms are worse when tension, anxiety, insomnia, light          stimulation and wind outside stimulation. At the same time, in the clinic，the          investigators found that facial nerve and trigeminal nerve combing can improve the          clinical symptoms of the patients. Therefore, the investigators speculated that over          activity were related to clinical symptoms and corneal reflex pathway of blepharospasm          patients.        4. Research content: the blepharospasm patients were randomly divided into two groups,          prospective comparative analysis of two different surgical methods for the treatment of          blepharospasm. One group of patients were performed facial nerve combing and          microvascular decompression, the other group of patients were performed facial nerve,          trigeminal nerve combing with microvascular decompression, to observation of          postoperative clinical improvement of two groups of patients.        5. Expected results:To define a surgical method for the treatment of blepharospasm, and to          promote the use of the academic and clinical practice.   "
39767|NCT02765100|"     The purpose of this study is to better understand the relationship between bipolar disorder,     body weight, and inflammation in the body. People with bipolar depression will be offered a     place in a pilot study looking to see if the antibiotic minocycline added to current     psychiatric medications has an effect on mood. A separate consent form will be provided for     the pilot study. Numerous studies have documented the presence of altered immune function and     elevation of inflammatory markers in patients with depression. Studies suggest that major     depression is accompanied by immune dysregulation and activation of the inflammatory response     system. While a small number of studies have found elevated inflammatory markers in bipolar     mania, very little has been reported about inflammation in bipolar depression, and none of     these studies have addressed the relationship of inflammatory markers with obesity in bipolar     disorder.   "
39768|NCT02765087|"     The purpose of this study is to determine the diagnostic utility of the device 'Electronic     Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the     current gold standard.   "
39769|NCT02765074|"     Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of     several cytokines, which leads to the destruction of bone and cartilage tissue in multiple     joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard     for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to     detect early erosive changes and is unable to evaluate periarticular bone loss.      High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm in     width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis of     cortical bone erosions, this one is also able to evaluate the volumes of erosion and the     evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process     and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal     antibody, developed and investigated in several clinical trials in RA. This biotherapy, in     association with methotrexate (MTX) or given in monotherapy, is efficient in RA with     inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically     systemic inflammation, structural progression and improves clinical symptoms and quality of     life.      Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone loss.   "
39770|NCT02765061|"     Coronary artery disease is a common medical disease in many populations. The pathogenesis of     this disease is very complex. Surgery is one of the treatment choices. Assessing the risk     factors will improve the surgical outcome. In this study some biochemical parameters were     evaluated to find out the relationship between these parameters (electrolytes and albumin vs)   "
39771|NCT02765048|"     The purpose of the study is to adapt and test an evidence-based trauma treatment program for     adolescent girls with histories of child maltreatment. The study adapts the CBITS (Cognitive     Behavioral Intervention for Trauma in Schools) program for delivery within community-based     settings for use with girls assessed and/or served by the child welfare system. The study     utilizes a randomized clinical trial that evaluates the effectiveness of the adapted program     entitled GAIN (Girls Aspiring toward Independence) compared with a usual care group. Primary     outcomes of the intervention are mental health symptoms such as PTSD, depression, and     internalizing and externalizing behaviors. Other outcomes include aggressive behaviors,     revictimization, and aggression-related beliefs, self-efficacy, and behavioral intentions.   "
39774|NCT02765009|"     Most ICU patients develop a positive fluid balance, mainly during the two first weeks of     their stay. The causes are multifactorial: a reduced urine output subsequent to shock state,     positive pressure mechanical ventilation, acute renal failure, post-operative period of major     surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable     arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in     relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually     in a cumulated positive fluid balance of more than 10 litres at the end of the first week of     stay. A high number of studies have showed that such a positive fluid balance was an     independent factor of worse prognosis in selected populations of ICU patients: acute renal     failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk     surgery. However, little is known about the putative causal role of positive fluid balance by     itself on outcome. However, in two randomized controlled studies in patients with ARDS, a     strategy of fluid balance control has been demonstrated to reduce time under mechanical     ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding     fluid overload is now recommended in ARDS management, there is no evidence that this approach     would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute     renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied     early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure.     There is a place for a prospective study comparing a conventional attitude based on liberal     fluid management throughout the ICU stay with a restrictive approach aiming at controlling     fluid balance, at least as soon as the patient circulatory status is stabilized. The latter     approach would use a simple algorithm using fluid restriction and diuretics based on daily     weighing, a common procedure in the ICU, probably more reliable than cumulative measurement     of fluid movements in patients whose limits have been underlined.   "
39775|NCT02764996|"     This will be an exploratory observational trial of rescue acupuncture for the treatment of     acute migraine in military beneficiaries to gain information to inform the power analysis of     a larger, more definitive trial. Researchers do not seek to definitively answer the question     of whether this acupuncture protocol is effective; rather, we seek to estimate the proportion     of migraine episodes that result in headache-free status 20-30 minutes, 2 hours, 4 hours, and     24 hours after an acupuncture treatment. Acupuncture treatments will be subject dependent,     and points could include the N point (on scalp); various auricular points to include Shen     Men, Point Zero, thalamus and Omega-2; body points to include Liver 2, Liver 3, Gall Bladder     20, bladder 10; and surface release over tense areas in the neck or shoulders. Researchers     will document the points used, and data will be aggregated to determine overall     effectiveness. Sub-group analysis by points will be performed to determine if there is more     usefulness in 1 point or combination of points. These estimates will inform statistical power     calculations for a future randomized controlled trial (RCT) that directly compares the     effectiveness of Rescue Acupuncture with medical management of acute migraine with rescue     medication. Researchers will also assess the feasibility of this study protocol as well as     patient receptivity and satisfaction.   "
39776|NCT02764983|"     Driving is a portal into general life functioning, and impaired driving skill can pose a     serious threat to the combat veterans (CV), passengers and others; and involves increased     risk of subsequent injuries, medical expenses and legal sequelae. Motor vehicle crashes (MVC)     among post deployed CV are one of the top four causes of injury and disability,     hospitalization, and outpatient visits across the military, and are a leading cause of death     among Army service members. The risk of motor vehicle (MV) death is significantly increased     in years immediately following return from the battlefield. In sum, the effects of Traumatic     Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and other blast related injuries,     combined with the battlefield mindset and lack of community reintegration programs place CV     at risk for MVC and fatalities. On-road assessments, the gold standard, presents a risk for     crash or adverse advents in this population of CV. Alternately, simulated driving evaluation     measures driving performance in a safe, accurate and objective manner with evidence of     absolute and relative validity when compared to real world (on-road) driving. Knowing     participants can or cannot safely resume driving, and providing rehabilitation for those with     a potential for resuming safe driving could result in: increased safe driving behaviors;     avoidance of injuries, collisions, citations and participants residua; and resuming safe     driving with its attendant benefits in the realms of family functioning, participation in     society and satisfaction with life. The overarching objective of this proposal is to discern,     after clinical and simulated driving performance testing , if Occupational Therapy Driving     Intervention (OT-DI) can improve the safe driving performance (less errors) over the short     term (immediately following intervention) and intermediate term (3 months).   "
39777|NCT02764970|"     Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened     regarding there baseline heart rate. If heart rate was > 75, patients were pretreated with     10mg bisoprolol (group 1) or 10mg bisoprolol plus 7.5mg ivabradine (group 2) to reduce heart     rate one our before CCTA was performed.      Heart rate, additional use of i.v. bradycardic agents, motion artefacts, radiation dose and     drug tolerance was monitored.   "
39778|NCT02764957|"     Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of     developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is     derived from unroasted coffee beans and has substantial amounts of polyphenols primarily     chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence     over Mets components including blood pressure, blood glucose, inflammation, oxidative stress,     insulin resistance and blood lipids. Up to our knowledge no study has been conducted on     humans in the field of GCA influences on Mets patients. Therefore, this study is planned to     evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood     pressure, lipid profile in patients with metabolic syndrome.   "
39779|NCT02764944|"     This study evaluates the feasibility of endo-laparoscopic full-thickness resection with     simple suturing technique which did not expose gastric mucosa to peritoneum (simple     non-exposure EFTR) in patients with gastric tumor.   "
39780|NCT02764931|"     The research aims to investigate the effects of gluten-free oats to the gastrointestinal     health in celiac disease patients and healthy subjects. The effects of gluten-free oats on     the several intestinal parameters, on the composition of the gut microbiota as well as on the     metabolic profile of celiac patients and healthy controls will be studied. The study is     divided into two parts.      Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over     study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants     for the part 1. The study will be conducted with a cross-over setting, where the subjects     will go through exposure meals and SmartPill ingestion three times (two different oat     products and placebo) in a randomized order. The study meals are identical in appearance and     fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which     will send data on intestinal pH, pressure and temperature to the external portable device.     Before and during the passage of capsule the subjects will fill a symptom and food diary. The     capsule will exit the body in 1 to 3 days and the data collected by the external device will     be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and     a blood sample. In addition, 36 hours urine samples will be collected.      In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls     will be recruited and they will be divided into four groups: oat-avoiding celiacs (1),     oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4).     Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a     fecal sample will be collected from the subjects. The gut microbiota will be analyzed from     the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood     samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing     techniques.   "
39781|NCT02764918|"     The purpose of this study is to investigate the incidence of Cryptosporidiosis in Bangladeshi     children and describe the acquired immune response to the pathogen as well investigate the     potential of human genetic susceptibility.   "
39782|NCT02764905|"     This will be a feasibility study. Individuals that have undergone an evaluation day at the     center for successful aging with diabetes with a Glycosylated hemoglobin (A1C) of >=7.5 and a     Montreal Cognitive Assessment (MoCA)<26 will be approached and invited to participate. The     participants will be divided into 2 groups: 1) information communication technology (ICT)     group - an intervention based on weekly SMS that will remind the individual to implement his     personal treatment plan and will raise the awareness to the importance of self-care in     diabetes; 2) intensive cognitive-physical rehabilitation group that will include a 2 phase     multi-disciplinary intervention. The 2 phases: a) Intensive phase: weekly 4 hour group     meeting which will include computerized cognitive training, aerobic, balance and strength     exercise and group discussion that will be dedicated to cognitive rehabilitation strategies     development and implementation with emphasis on disease management and physical activity as     well as psycho-education on various disease management aspects (medical and nutritional) b) a     consolidation phase: monthly 2 hour group discussions on challenges of implementation and     coping strategies. Outcomes will include change in A1C (primary), change in strength, aerobic     capacity as well as quality of life and cognitive function (secondary). Additionally, team     members and participants will fill out a structured questionnaire regarding their evaluation     of the program aiming at refinement of the intervention.   "
39783|NCT02764892|"     The main purpose of the study is to identify the best dose of V81444 to use in future trials     in patients with Parkinson's disease. The study will also explore the effects of V81444 on     brain activity and blood flow with tests of mental ability (cognitive function tests). It     will also check how safe V81444 is and how well it is tolerated after dosing.   "
39784|NCT02764879|"     The study was aimed to investigating changes in periodontal parameters and superoxide     dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3     FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements     reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in     postmenopausal women.   "
39785|NCT02764866|"     The study seeks to determine the prevalence of sleep disordered breathing in a population of     patients diagnosed with lung cáncer.   "
39786|NCT02764853|"     Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at     developing an intervention for Black women living with HIV to address psychosocial factors     (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and     prescribed traditional gender roles) that have been associated with medication nonadherence     or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.   "
39787|NCT02764840|"     Resistance exercises from elastic tube has been used as part of the rehabilitation and     maintenance of muscle tone levels in different scenarios, from disease conditions to the     sports universe. There is the convenience and low cost of the instrument, which can provide     impact on clinical and economic framework in case of spillage of use strategies. In a recent     search, the investigators were not observed data on the reliability and reproducibility of a     specific test for this tool and in this sense, it seems pertinent to undertake research on     the topic. Objectives: To determine the reliability and reproducibility by comparison with a     isokinetic muscle strength test located â fatigue held in elastic tube and compare the     results of a training protocol for muscle strength gain in both methods, elastic tube and     dynamometer. Methods: Participants will perform the muscular endurance test localized     fatigue, on two occasions, with an interval of seven days between them. Everyone will     accomplish so much in the elastic tube, as in the isokinetic dynamometer. It will be held     evaluator analysis intra and inter evaluator. After first stage of the study to determine the     reliability test, the participants will undergo three weeks of training to gain muscular     endurance, distributed in two groups G1 (training in the elastic tube) and G2 (training in     isokinetic dynamometer) previously randomized. It will use the intra-class correlation     coefficient with 95% confidence interval to check the repeatability and the Kappa coefficient     with 95% confidence interval for reproducibility. To compare the responses of training, the     distribution will be made as to the normality of the data by the Kolmogorov-Smirnov test. In     the case of normal distribution, the Student's t-test for unpaired data and Mann-Whitney will     be adopted if there is no normal distribution.   "
39788|NCT02764827|"     Pollen allergen extracts are prepared locally and checked for efficacy by comparison to     imported allergens and specific IgE.   "
39789|NCT02764814|"     Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional     treatment in patients with moderate to severe Dry Eye Disease (DED)   "
39790|NCT02764801|"     The primary objective of this trial is to evaluate the sensitivity and specificity of 2D and     4D contrast enhanced ultrasound for monitoring transarterial chemoembolization (TACE)     response 1-2 weeks and 1 month post treatment as an alternative to contrast-enhanced magnetic     resonance (MRI) or computed tomography (CT) imaging   "
39791|NCT02764788|"     Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, and one     of the most frequent causes of referral to the pain management unit. It affects mainly women;     they are referred by a rheumatologist, an internal medicine physician or by their family     physician.      FM produces various degrees of disability and pain, and has an important impact on quality of     life. Sleep disorders, fatigue and cognitive dysfunctions are almost always part of the     clinical presentation. The wide range of symptoms and signs, the unknown etiology, the lack     of efficacy of pharmacological treatments make management of FM a very difficult task. In     France the consensus includes limitation of pharmacological treatment, encouraging physical     rehabilitation and referring the patients to a specialized pain clinic where     multidisciplinary management will be undertaken. In our hospital the investigators favor non     pharmacological therapies and propose to the FM patients to learn relaxation and     self-hypnosis, physical rehabilitation and use of trans cutaneous electrical     neurostimulation.      Auriculotherapy (AT) is a complementary therapy, based on the idea that the ear is a     microsystem which reflects the entire body, represented on the auricle, the outer portion of     the ear. Mapping of the auricle has been described, according to the fact that pathology of     different organs can induce specific changes in the auricle, for example color change or     sensitivity. Treating specific areas, which somehow would be connected to the affected     organ could also improve the functioning of the body or relieve pain. AT uses placement of     needles at points tailored to the patient's pathology. Whatever the mechanisms involved, the     effectiveness of ATis currently supported by randomized controlled trials. It is validated by     WHO since 1987, mapped in an international nomenclature initially proposed by Nogier.      The investigators regularly use AT in FM patients in our pain management unit to alleviate     symptoms as pain, sleep disorders, anxiety. The investigators established a clinical trial in     this population to assess impact of FM (assessed with Fibromyalgia Impact Questionnaire)     following 3 months of AT management (Primary Outcome). Sleep disorder, fatigue, anxiety and     depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. The     remnant effect of AT is also evaluated, 3 month after the end of the treatment by the same     tests.   "
39792|NCT02764775|"     Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive     diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization,     surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum     of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the     Headpod. Video will be taken to document changes.   "
39805|NCT02764606|"     CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the     value of new serum markers to predict the occurrence of metastases in patients with     early-stage non-small cell lung cancer. This would represent a rational to develop     personalized follow-up and prevention strategies   "
39793|NCT02764762|"     The purpose of this study is to determine the effect of triple combination therapy with an     anti-integrin [vedolizumab intravenous (IV)], a tumor necrosis factor (TNF) antagonist     [adalimumab subcutaneously (SC)], and an immunomodulator (oral methotrexate) on endoscopic     remission in participants with newly-diagnosed Crohn's disease stratified at higher risk for     complications.   "
39794|NCT02764749|"     Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as     cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced     cholesterol and decreased cardiovascular risk. Cranberries are a rich source of     (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether     cranberries can improve vascular function when given over relevant time periods and in     relevant populations is not known. Therefore, it is the overall hypothesis of the study     proposal that chronic consumption of cranberries can improve endothelial function, a     prognostically validated surrogate of cardiovascular risk. This study also aims to reveal     which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma     and urine metabolite peaks will be correlated with vascular outcomes and genome-wide     expression microarrays will be performed to reveal cell signaling pathways associated with     cranberry (poly)phenol-mediated cardioprotective events.   "
39795|NCT02764736|"     The specific aim of this trial is to determine whether initiating moderate- or high-intensity     atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation     and lowers average Epogen utilization. Statin naive patients on maintenance HD will be     started on 20mg atorvastatin daily for weeks and then titrated up to 40mg atorvastatin daily     for an additional 12 weeks. Patient's inflammatory markers (ferritin, CRP) and weekly Epogen     usage will be monitored.   "
39796|NCT02764723|"     The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with     isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing     lower limb orthopedic surgery.   "
39797|NCT02764710|"     The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and     augmentation surgery is unknown. This is a comparative open label interventional trial     comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate     with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome     is the postoperative surgical site infection in the standard versus the short treatment arms.     Secondary outcomes are drug-related adverse events and Clostridium difficile infection.   "
39833|NCT02764307|"     Background: Nebulizers design influences efficiency of aerosol delivery. Performance of     nebulizers is commonly tested by breathing simulators with static parameters. However,     breathing patterns vary in adults.      Objectives: The purpose of this study was to evaluate drug deposition of different types of     nebulizers testing with breathing patterns of healthy subjects.   "
39798|NCT02764697|"     Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory     reaction involving ocular tissue and vasculature. The inflammation usually causes pain,     redness, photophobia and blurred vision. This inflammation, is typically treated with     regional or systemic therapy. The regional therapy typically consists of topical     corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a     steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to     evaluate the possible effectiveness of H.P. Acthar in patients with active ocular     inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.   "
39799|NCT02764684|"     Objective:      In this study the investigators aim at investigating:        1. probiotics ability to modulate the microbiome and microbial translocation,        2. if probiotics affect the level of cholesterol, triglycerides as markers of          cardiovascular risk factors and        3. if a reduction of microbial translocation is associated with a reduction of inflammation          in the gastro-intestinal tract.      Design:      The study is a prospective clinical intervention trial of 40 HIV-infected patients.      Method:      The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to     each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention,     the investigators will collect blood samples, feces samples and make a positron emission     tomography-magnetic resonance scans.   "
39800|NCT02764671|"     The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml     Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.   "
39801|NCT02764658|"     The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a     biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than     CRP for confirming COPD severity and acute exacerbation frequency. It was related to the     1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an     immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in     mice. Previous report showed that voluntary wheel running and fluid flow shear stress that     promote the expression of the Prg4 and association with pulmonary inflammation. COPD patients     are characterized by a progressive decrease of lung function that is associated with     increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to     decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and     improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The     current study aimed to study in the pulmonary inflammation and the effectiveness of pulmonary     recovery in COPD Patients：The mechanism of PRG 4.   "
39802|NCT02764645|"     This is a single center, prospective study:      The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the     control group.   "
39803|NCT02764632|"     Insertion of a nasogastric tube (NGT) in anesthetized patients can be a disappointing     experience. Many techniques have been explained to improve success rate along with increasing     safety, such as forward displacement of the larynx, tube rigidity improvement methods,     pushing it down directly through pharynx or using a guide tube. Failure of insertion under     general anesthesia reached 50% in some publications   "
39804|NCT02764619|"     A randomized, double-blinded, placebo-controlled study to evaluate the effect of     spironolactone in addition to conventional treatment compared with placebo in patients with     paroxysmal and persistent atrial fibrillation with preserved left ventricular ejection     fraction by T1 mapping, structure and function of left atrium and ventricle assessed by     transthoracic echocardiography and cardiac magnetic resonance (CMR), the number of recurrent     episodes of atrial fibrillation and biomarkers measured in blood.   "
39808|NCT02763527|"     Background: Smokers attended to outpatient clinics present an excellent 'teachable moment'     for smoking cessation interventions. This protocol paper describes the rationale and methods     of a large randomized controlled trial which aims to evaluate the effectiveness of     negotiating self-determination to reduce cigarette consumption among smokers attending     outpatient clinics      Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong     Kong. Subjects in the intervention group will receive a brief intervention on smoking     reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think     about a smoking reduction schedule for themselves after the negotiation with the counsellor.     Subjects in the control group will receive a brief advice on quitting plus a leaflet on     smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted. The     primary outcome measure is biochemically validated abstinence at 6 months. Secondary outcomes     are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day point     prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in     cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12     months.   "
39809|NCT02763514|"     The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3     polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory,     attention, working memory, executive function), subjective mood, alertness and mental fatigue     after 26 weeks daily supplementation.   "
39810|NCT02763501|"     Comparison of participants in a randomised controlled trial (RCT) with observational data     from patients operated in Sweden during the same period of time. The primary objective is to     compare effects from a complex surgical intervention from RCT and observational data.   "
39811|NCT02763488|"     This study will evaluate blood flow restriction training as a rehabilitation modalities     following total knee arthroplasty in order to determine if patient reported outcomes and     objective functional outcomes can be improved through post-operative rehabilitation compared     to standard physical therapy modalities currently in use.   "
39812|NCT02763475|"     The main goal of this study is to evaluate the anti-relapse prophylactic activity of     inoculating Natural Killer (NK) cells as consolidation therapy of acute myeloid leukemia in     paediatric patients with cytologic remission. The patients included have intermediate risk of     relapse and no indication for allogeneic hematopoietic stem cell transplantation.      After the standard induction and consolidation chemotherapy treatment, patients will receive     five days of fludarabine to try to kill any minimal residual disease and prevent NK cell     rejection. Two different NK cells infusions will be performed within one week (day 0 and 7).     Interleukin 2 (IL-2) will be administrated to increase the cytotoxic activity of NK cells.   "
39813|NCT02764567|"     Lab sampling for clinical trial participants can be a stressful and painful experience. Most     trial participants will have blood drawn for lab samples at multiple study visits. The     participants must fast for up to ten hours before the blood sampling, in many cases, and     patients often report a painful experience if more than one venipuncture occurs. In addition,     the number of collection tubes can increase the anxiety level of the patient and the     phlebotomist.      This project proposes to evaluate if essential oil aromatherapy results in less pain and /or     anxiety when compared to usual care.   "
39814|NCT02764554|"     The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of     Lenvima (lenvatinib) in normal clinical practice setting.   "
39815|NCT02764541|"     This research study is evaluating how well Breast Cancer responds to preoperative treatment     with Endocrine treatment in combination with a drug called Palbociclib or Endocrine treatment     alone as possible treatments for Hormone Receptor Positive Breast Cancer.   "
39816|NCT02764528|"     The purpose of the handwashing intervention trial is to determine whether an interactive,     storytelling approach to promoting handwashing with soap by health care workers can improve     mothers' handwashing behavior during the first month of her child's life.   "
39817|NCT02764515|"     This is a multicenter, randomized, double blind, double-dummy and controlled clinical trial     aimed to compare the clinical efficacy and safety of Kunxian Capsule, a compound of Chinese     traditional medicine, and the active comparator,Methotrexate for the treatment of rheumatoid     arthritis. The primary end-point is that Kunxian Capsule is not inferior to Methotrexate both     in efficacy and safety.   "
39818|NCT02764502|"     Introduction Several attempts have been made to improve or facilitate epidural space     detection beside conventional loss of resistant technique. Recently many sophisticated     equipment's and techniques have been described which did not received widespread popularity.      Objectives The Investigator describes and assesses the validity of using Pressure Gauge     Manometer to confirm correct detection of lumber epidural space, in an inexpensive way.      Methods Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the     interspinous ligaments ( nearly 2cm mark on the needle).A3-way stopcock is connected to the     hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml     syringe. Using a 75 cm extension tube set and create a 30 mm Hg pressure gradient between     manometer and the tip of epidural needle , the needle is advanced slowly using both hands     while monitoring the manometer reading and is stopped when the pressure suddenly dropped (     the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space     ).   "
39819|NCT02764489|"     The purpose of this study is to:        -  1. To compare the pharmacokinetics (PK) of Factor Eight Inhibitor Bypassing Activity          (FEIBA component Factor II (FII) and safety of FEIBA reconstituted in a reduced volume          of sterile water for injection (SWFI) versus regular volume SWFI, administered at the          standard infusion rate of 2 U/min/kg        -  2. To evaluate the safety of infusing reduced volume FEIBA at increased rates of 4 and          10 U/min/kg in comparison to the standard rate of 2 U/min/kg   "
39820|NCT02764476|"     The purpose of this study is to design and test the safety and feasibility of virtual reality     technologies and experiences of egocentric avatar embodiment in the application of physical     and cognitive behavior therapy in functional neurological symptom/conversion disorder.     Investigators hypothesize that patients will safely use and accept this modality of treatment     and will show evidence of a decrease in symptom frequency.   "
44852|NCT02698592|"     The purpose of this study is to determine whether the Thermocool SF ® system is at least as     effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of     cavo-tricuspid isthmus dependent atrial flutter.   "
39821|NCT02764463|"     This prospective clinical study evaluated the performance of indirect, posterior     occlusal-retained, fiber-reinforced-composite restorations.      Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62 years     old ( 33 male, 25 female) received 65 FCRFPD prosthesis.      All restorations were made indirectly on a plaster model using unidirectional E-glass fibers     (Vectris- Ivoclar Vivadent, liechtenstein) in combination with a laboratory resin composite     (Signum, Heraeus-Kulzer) and cemented according to the instructions of resin cement Variolink     II (Ivoclar Vivadent). After baseline recordings, patients were followed at 6 months and     thereafter annually up to 15 years. The evaluation protocol involved technical (chipping,     debonding or fracture of tooth/restoration) and biological failures (caries).   "
39822|NCT02764450|"     This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I     and Class II restorations made of microhybrid composite and applied using two polymerisation     protocols,   "
39823|NCT02764437|"     The investigators have identified areas of the brain that are activated in response to     disease-related emotional information, following whole lung allergen challenge in asthma.     They propose that activity in these central nervous system locations, as measured by fMRI, is     associated with the intensity of allergic inflammation, provoked by segmental bronchial     challenge, in the absence of significant airflow obstruction. The investigators predict that     this relationship will be mediated by changes in expression of genes in the IL-1β/IL-17     pathway.   "
39830|NCT02764346|"     This study will look at the use and impact of smartphone application (app) for adolescents     with ongoing pain caused by their juvenile idiopathic arthritis (JIA).The current project     will include three studies. First, the investigators conducted usability sessions with     adolescents with JIA to refine the app so that it is usable, acceptable and understandable.     The aim of this study is to look at (a) how regularly the iCanCope with Pain app is used     and (b) any effect the app has on young people's health. This study will compare two groups     of young people: one that is using the new app, and one that receives usual medical care.   "
49597|NCT02636452|"     In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom.     Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate     cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.   "
39824|NCT02764424|"     Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures     is a daily and essential concern for the caregiver neonatologist. The quantification of pain     is needed to effectively adjust analgesic therapy and by the way, to limit side effects.     Several pain scales are now validated for newborns but they are based on one-off measures and     hetero assessments often dependent on many factors including the operator.      Recent developments in the real time analysis of the cardiac signal under the influence of     autonomic control, have led to the development of a new painful stress index. A monitor has     recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index     (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic     Evaluation - in newborns). It is based on the study of the heart rate variability and the     variations of the sympathetic and parasympathetic indices to stimuli. The validation of this     nociception index has not been validated in a neonatal unit where special attention is paid     to pain control.      The main purpose of our study is to show the consistency of this NIPE index (adapted to     newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children,     hospitalized in intensive unit and neonatal intensive care unit from the University Hospital     of Saint-Etienne (France).      The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and     42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of     our university hospital (Saint-Etienne - France), who have to acute painful stimuli related     to their care.   "
39825|NCT02764411|"     Capillary Malformations (CM) affect a significant proportion of otherwise healthy children     and may lead to psychological discomfort if left untreated. A significant proportion of     untreated lesions undergo soft tissue thickening and darker discoloration later in life due     to progressive ectasia of the affected vessels. While laser treatment is available, its use     may be limited due to need for repeated sedation/general anesthetic use, partial response and     cost.      The investigators propose to conduct an open-label, prospective, cohort study using Onreltea     ( Brimonidine) gel for treatment of facial capillary malformations in children. The study     medication will be applied topically on affected area of the skin daily for 12 weeks. Follow     up visits will occur at at Week 1,4,8,12, and 16 to assess the efficacy and safety of the     proposed treatment.      The study second aim is to explore the feasibility of conducting a multicenter placebo     controlled study.   "
39826|NCT02764398|"     Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective     ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear     but may be attributed to an autonomic nervous reflex induced by catheterization of the     ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia     and catheter stimulation might be a support cause of these SCRE.      Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma     are prospectively included in this observational study. Endovascular procedures are performed     under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium.     SCRE are strictly pre-defined and included arterial hypotension, bradycardia and     bronchospasm. SCRE are recorded and the factors influencing their occurrence are     investigated.   "
39843|NCT02764177|"     Whilst the effects of manipulating the macronutrient content of foods on appetite and energy     intake has been relatively well studied at rest, little is known about these responses in a     post-exercise context. The effect of post-exercise nutrition on recovery from or adaptation     to exercise has been well studied. However, many exercisers do so for weight management and     thus any post-exercise nutrition might impact on energy balance and might need to be     carefully considered. This study will examine the impact of manipulating the composition of a     recovery drink consumed after resistance exercise on subsequent appetite and energy intake.   "
39844|NCT02764164|"     Youths diagnosed with early onset schizophrenia will demonstrate amelioration of auditory     hallucinations after one week of twice daily treatment with transcranial direct current     stimulation (tDCS).   "
39845|NCT02764151|"     This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in     patients with malignant gliomas.   "
39827|NCT02764385|"     This study will compare the effectiveness of two approaches for delivering smoking cessation     advice in the primary care setting. Ask-Advise-Connect (AAC) is a strategy that uses the     electronic health record (EHR) to prompt clinical staff to Ask if the patient smokes, Advise     them to quit and, if they're interested, Connect them to Quitline (QL) counseling services.     The connection occurs when a QL counselor is notified of the patient's interest, and then     calls the patient to enroll in treatment. AAC has been shown to be very effective at     enrolling patients, however, it was found that less than 42% of patients who agreed to be     referred were successfully contacted by the QL after 5 call attempts. This indicates that     many patients that are referred are not ready for cessation, but may feel obligated to accept     the referral from their primary care team. This presents an opportunity to improve the     patient centeredness of the referral process.      To overcome these limitations, the investigators propose pairing it with a patient-centered     smoking cessation approach called the Teachable Moments Communication Process (TMCP). The     investigators' team developed this communication strategy, which incorporates patients'     concerns into a partnership-oriented discussion about smoking cessation. The investigators     propose that combining these two approaches could increase appropriate referrals to the QL,     increase the likelihood of successful patient contact and enrollment, and increase the     patient's rating of the value of the experience.   "
39828|NCT02764372|"     The aims of the present study were to:        -  Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on          Kinect, to augment upper extremity neurorehabilitation services.        -  Provide preliminary evidence of clinical efficacy of the approach in increasing arm          activity and health related quality of life of persons post stroke or with MS.      Main results suggest that the serious games approach was positively received in terms of user     experience and motivation to use, with the participants showing also improvements in     functional abilities of the treated arm.   "
39829|NCT02764359|"     Obesity alters the movement through the body of several antibiotics, including vancomycin.     Based on literature to date, total body weight should be used to determine dosages and     shorter dosing intervals may be needed. However, hospitals have different approaches to     managing vancomycin in this patient population. The most common example is not exceeding a     dose of 2,000mg of vancomycin at one time in these patients. However, some institutions     including the Charleston Area Medical Center do not have a set maximum one time dose. To     date, a study has not been done comparing two different dosing regimens in obese patients to     determine if having a maximum dose cap is beneficial.      This research study is attempting to add to the limited existing body of literature regarding     vancomycin dosing in obese patients. The investigators hypothesize that optimizing the     initial or loading vancomycin dose that obese patients receive will decrease the time to     target concentrations. For this study, obese adult patients will be randomized to receive     either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose     of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine     differences in the time needed to achieve target vancomycin concentrations and the occurrence     of adverse events.   "
39834|NCT02764294|"     Cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction before     and during the procedure. Especially male patients feel more pain than females during     cystoscopy. The aim of this study is to compare effectiveness of three different distraction     methods on pain, anxiety and satisfaction of the male patients during cystoscopy.   "
39836|NCT02764268|"     Apatinib dose titration in Advanced or Metastatic Gastric Cancer   "
39837|NCT02764255|"     cases with embyos cultured in the standard incubator and evaluated only by morphology are     compared to cases with embryos continuously monitored by the embryoscope followed by embryo     selection based on a multivariable model   "
39838|NCT02764242|"     Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are     important but false positive by crossreactivity can occur. sIgE to recombinant venom allergen     is proposed to help in finding the causative insect.   "
39839|NCT02764229|"     The purpose of this study is to allow subjects completing study LYC-30937-2001 the     opportunity to receive LYC-30937-EC 25 mg.   "
39840|NCT02764216|"     The optimal treatment of HNCUP remains controversial and lacks evidence from prospective     randomized trials. The management of these patients relies primarily on surgery and     radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains     controversial. The main debate concerns the extent of the radiation field. Although     pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes     reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated     with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most     single institution retrospective studies have not shown any advantage for more extensive     irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these     patients.   "
39841|NCT02764203|"     The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on     blood pressure and compare outcome data derived from wearable/digital health devices to data     derived from standard methods. Additionally, the usability of the wearable technology will be     evaluated.   "
39842|NCT02764190|"     Adolescents have some of the highest rates of risk behaviors of all age groups and health     behaviors developed in adolescence can persist into adulthood. These behaviors carry     significant risks for subsequent disease, disability, and healthcare burden. Despite these     risks, health risk screening in primary care is infrequently performed and results are rarely     followed by targeted intervention. In response to the need for screening-linked     interventions, our study team has developed a web-based, electronic Personalized Motivational     Feedback tool which we refer to as Check Yourself. Based on motivational interviewing, a     technique to mobilize personal change, Check Yourself is designed to promote healthy choices     for the multiple behaviors relevant to adolescents as well as to provide information to     providers to promote discussions around health behaviors between providers and adolescents.      Building on electronic health interventions, primary care providers can play an essential     role in helping adolescents to make healthy behavior choices. Emerging evidence suggests that     the consistency of preventive counseling can be increased through provider training and the     provision of screening tools; yet, we know very little about the quality of such counseling,     and if it impacts outcomes that are important to adolescent patients themselves.      This study is a stepped-wedge, controlled trial comparing the effectiveness of an interactive     adolescent-centered training for primary care providers (I-ACT) and Check Yourself to usual     care. This study will take place in six pediatric practices. The purpose of this study is to     determine whether this system of interventions (i.e., I-ACT, Check Yourself, and the summary     report) is more effective than usual care in reducing health risk behaviors, improving     adolescent motivation for health, and improving quality of care among adolescents receiving     primary health care services.   "
39846|NCT02764138|"     Racial and socioeconomic disparities in physical and mental health problems are large,     persistent, and severe; begin during childhood; and stem from in part damage to physiologic     stress response systems caused by chronic stress. Discovery of ways to prevent and/or halt     this progression of damage to a child's stress response system may offer new directions for     combatting health disparities. This project will evaluate the efficacy of a new prevention     program designed to teach preadolescent children effective ways for coping with chronic     stress that will have direct effects on their physiologic stress response systems     (hypothalamic-pituitary-adrenal axis) and ultimately prevent onset of anxiety, depression,     and post-traumatic stress symptoms and disorders.   "
39847|NCT02764125|"     This will be a randomised, crossover, double-blind, double-dummy, active-controlled,     multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with     end-of-dose wearing-off (motor fluctuations).   "
39848|NCT02764112|"     ASSESSING THE ABILITY OF WARFARIN TREATED PATIENTS TO PREDICT THEIR INR Kathleen McNamara,     James Hoehns, Matthew Witry      The international normalized ratio (INR) is the accepted lab test used to measure the     intensity of warfarin effect. The conventional wisdom is that patients receiving warfarin are     unable to correctly determine, in the absence of an INR result, whether or not they are     therapeutic at any given time. Some warfarin treated patients express that they have insight     into what their INR result will be. Various patient related factors may contribute to these     opinions.      Our objective is to assess how accurately patients can guess their INR result before it is     obtained and to describe factors which inform their opinion of what their INR will be.   "
39960|NCT02762565|"     Early detection of breast cancer improves the survival rate and makes treatment less costly.     This study would measure the accuracy a low-cost hand-held commercially viable device, iBE,     for the detection of clinically relevant findings in the breast using the results of current     mammography as a comparison. This research will have no impact on clinical decision making.   "
39849|NCT02764099|"     The proposed research is designed to adapt and test an evidence-based drug abuse prevention     approach for use in youth courts among first-time, non-violent, adolescent offenders. The     ultimate goal is to reduce the adverse health, legal, and social consequences of youth drug     abuse, violence, and delinquency. Planned project activities include conducting: 1) key     informant interviews of youth court directors regarding logistical and intervention features     of effective youth court programming; and, 2) a randomized controlled efficacy trial of an     adapted version of Life Skills Training, an evidence-based drug and violence prevention     program. It is anticipated that the findings will provide critical information on     implementing evidence-based prevention programs for new populations and settings and will     support preparations for a large-scale effectiveness trial in youth peer courts.   "
39850|NCT02764086|"     This is a prospective non-randomised Phase I/II study with patients recruited to escalated     dose cohorts. Escalated dose to the iGTV (internal gross tumour volume), with 60 Gy to the     conventional PTV (planning target volume), will be delivered to successive cohorts of     participants (6-12 participants/cohort) until the maximum tolerated oesophageal dose is     determined. The minimum dose will be 60 Gy delivered via intensity modulated radiation     therapy (IMRT) or volume modulated arc therapy (VMAT), planned on an Average Intensity     Projection (AVIP) dataset.      Standard of care chemotherapy.      There will be two treatment arms; one with patients who are planned to receive neo-adjuvant     or no chemotherapy, and the other with patients who are planned to receive concurrent     chemotherapy.   "
39851|NCT02764073|"     Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and     mortality remains substantially high worldwide. Pulmonary congestion is considered the     leading cause for hospital admissions and death among patients with HF. Physical examination     is crucial for titrating medical treatment in these patients, but despite a good specificity     it is not sensitive enough to detect early elevated cardiac filling pressures.      The N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a recognized powerful predictor     for HF prognosis. Recently, cardiotrophin-1 and galectin-3 have been proposed as new relevant     biomarkers for HF evaluation.      Echocardiography can be also used to noninvasively measure left ventricular filling     pressures. Lung ultrasound (LUS) through interstitial B-line evaluation has been recently     proposed as a bed-side, noninvasive tool to assess interstitial lung water. B-lines correlate     with NT-proBNP and E/e' levels in patients with acute dyspnea, chronic HF or after a stress     test. LUS can also identify clinically silent pulmonary edema, suggesting that it may     complement clinical evaluation to improve hemodynamic profiling and treatment optimization.      Biompedance is a bedside method for total body fluid status assessment. It defines individual     fluid status/compartments/overload on the basis of an individual's normal extracellular     volume and body composition. Recent studies indicate that bioimpedance-derived fluid overload     indices are independent predictors of mortality in renal failure patients.      To date, no study has evaluated bioimpedance performance for fluid assessment in HF patients.     The investigators aim to cross-sectionally compare bioimpedance parameters with clinical     evaluation, LUS, cardiac biomarkers, and echocardiographic characteristics, in a cohort of     incident consecutive patients with HF. Two years patients' survival will be evaluated to     propose the best evaluative algorithm and rank the various methods for prognostic     significance.   "
39852|NCT02764060|"     The aim of this study was to examine in periodontitis patients with visible tongue coating     the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper     versus the use of a regular toothbrush to clean the tongue.   "
39853|NCT02764047|"     Evaluate the effect of supplementation of probiotics on liver changes (histological and     enzymatic), lipid profile and gut microbiota of patients with nonalcoholic steatohepatitis     (NASH).   "
39865|NCT02763891|"     This study evaluates the effect of body suspension and tilting exercises (performed in     Chordata apparatus) on the balance and mobility of subjects with Parkinson disease. Half of     patients will perform the exercise protocol while the other half will receive passive muscle     stretching and maintain the usual routine.   "
39866|NCT02763878|"     The investigators intend to conduct multi-center randomized controlled study to find if Uncut     Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the     long-term complications, affect the quality of life, and improve the prognosis, comparing to     Billroth II anastomosis.   "
39964|NCT02762513|"     This study will be a prospective, single-institution, single-arm phase II study of Axitinib     in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma.     The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously,     with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2     or worse toxicities. This will be followed by clinical and/or radiologic response assessment     after 8 weeks and subsequently every 2 months until disease progression or intolerable     toxicity.   "
39854|NCT02764034|"     The human endometrium is an extremely sensitive target. LLLT can enhance the proliferation     rate of various cell lines, it produces higher rates of ATP, RNA, and DNA synthesis in stem     cells and other cell lines. Thus, LLLT improves the proliferation of the cells without     causing any cytotoxic effects.      The aim of this work is to assess the ability of low level laser therapy in enhancing     endometrial proliferation and increasing endometrial receptivity.      A number of 120 human endometrial samples will be studied, and will be collected from 40     infertile women attending the infertility clinic at NRC. Each human endometrial sample will     be divided into 3 plates, in order to establish 3 main groups of 40 culture plates for single     laser exposure group versus 40 culture plates for multiple laser exposure group and 40 tissue     culture plates for control samples, thus a total of 120 tissue culture plates will be     studied, the study groups will be exposed to low level laser therapy and compared to their     matched controls.. Assessment of number and size of cells after LLLT as a marker of normal     proliferation and b) The expression of Integrin aVB3 alpha v B3, MUC-1 and LIFand the     development of pinopodes on the surface of epithelial cells as markers of endometrial     receptivity and the detection of PTEN tumor suppressor gene as a marker of abnormal     proliferation or premalignant condition will be performed to assess the effect of LLLT on the     endometrial cell culture. This study might offer a new therapeutic modality which might     increase endometrial thickness and enhance receptivity .   "
39855|NCT02764021|"     Scientific evidence for the dietary treatment of type 2 diabetes (T2D) is insufficient. The     study group hypothesizes that a lower carbohydrate content in the diabetic diet than the     recommended 55 energy percentage (E%) will decrease the postprandial glucose excursion. This     will reduce postprandial insulin concentration, which together with lower glucose     concentration leads to less fat accumulation in the liver and muscle tissue, resulting in an     improved insulin sensitivity which together with a reduced glucose load improves the glucose     metabolism. This clinical study will examine in subjects with type 2 diabetes the effect of     highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to     insulin action, pancreatic islet function, lipid metabolism, ectopic fat accumulation,     incretin hormones, low grade inflammation in plasma and adipose tissue, novel measures of     fatty acid metabolism, and heart rate variability, respectively. The studies exhibit the     potential to reform dietary recommendation aiming to prevent and ameliorate type 2 diabetes.   "
39873|NCT02763787|"     The purpose of this study is to investigate the safety and tolerability of single oral rising     doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg     and 800 mg) in groups of 9 healthy male adult subjects, to characterise the preliminary     pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult subjects, to     investigate the effects of single doses of BIA 3-202 on COMT activity in human erythrocytes     and to investigate the effect of food on the pharmacokinetics of a single dose of BIA 3-202.   "
39986|NCT02762227|"     This prospective cohort study is designed to investigate and to compare the diagnostic     performance of contrast-enhanced ultrasonography (CEUS) and multidetector computed tomography     (CT) for gallbladder cholesterol polyps, adenoma and gallbladder cancer.   "
39856|NCT02764008|"     Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the     standard treatment for large and complex renal stones. Although it has lower complication and     morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can     cause distress for patients.      Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation,     which defeat the purpose of this minimally invasive procedure.      Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration     of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting     the role of renal capsule in pain management.      Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy     tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block     offers the option of providing extendable perioperative pain relief without the above side     effects or the physiologic derangement associated with local anesthetics in the central     neuraxial space.      The aim of this study is to determine whether ultrasound guided low thoracic paravertebral     block effective post-operative analgesia as compared to peritubal infiltration analgesia in     patients undergoing percutaneous nephrolithotomy.      Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary     endpoints are visual analogue pain scores, opioid related side effects.   "
39857|NCT02763995|"     Cardiovascular diseases (CVD) are the main cause of death in Spain. In HIV patients, the     uncontrolled viral replication, antiretroviral therapy (ART) and coinfections contribute to     develop metabolic diseases and increase the prevalence of risk factors for CVD. These     patients are aging which results in a higher probability of comorbidities, increased number     of medications, possibility of having a negative outcome associated with medication (NOM) and     increased cardiovascular risk (CVR). Various studies have established that pharmaceutical     care (PC) results in better control of cardiovascular risk factors.      The purpose of this study is to evaluate the impact of pharmaceutical care achieved through     pharmacotherapy follow-up on cardiovascular risk and health related quality of life (HRQoL)     of HIV patients older than 50.   "
39858|NCT02763982|"     The purpose of this study is to determine whether ejection fraction and peak oxygen uptake     have correlation on inspiratory muscle strength, chest wall volumes and quality of life in     individuals with heart failure.   "
39859|NCT02763969|"     The purpose of this study is to establish if BMS-986202 is safe and effective at treating     autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical     studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first     time this drug is given to humans.   "
39860|NCT02763956|"     Degenerative Disc Disease is one of the most common spinal pathologies, affecting up to 10-15     % of adults. The purpose of this study is to evaluate the efficacy of treatment with the     GelStix™ device in a patient population with discogenic pain that had no benefit from     conservative care.   "
39907|NCT02763254|"     To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the     treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and     Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.   "
39861|NCT02763943|"     There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor     control on graft survival disparities in Black transplant recipients. Studies in the general     population indicate that CVD risk factor control is poor in Black patients, leading to higher     rates of renal failure and CV events. However, with the exception of hypertension, there is     paucity in data demonstrating similar results within transplant recipients. Recent analyses     conducted within our transplant program, indicate that CVD risk factors, especially diabetes,     are poorly controlled in Black recipients, which likely impacts graft loss. Since these data     were collected in a retrospective manner, larger analyses are needed to validate these     exploratory findings.      This pilot study is to:        1. Determine if the study is feasible, as measured by the proportions of enrolled to          approached and completed to enrolled.        2. Measure and compare, at baseline versus the end of the intervention, the medication          safety events, including the number of medication errors, medication non-adherence and          medication side effects, in patients enrolled in the study        3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor          control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the          study        4. Measure and compare, at baseline versus the end of the intervention, patient reported          survey results, in patients enrolled in the study        5. Determine if the impact of the intervention is more pronounced in Black recipients, as          compared to non-Black recipients   "
39862|NCT02763930|"     Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese     consumption, with potentially important impact on this key industry in Canada. This is in     part due to the commonly accepted notion that saturated fat in the diet, of which cheese     contributes significantly, increases the risk of heart disease. Yet, a rather large body of     recent evidence suggests that saturated fat may have been unfairly demonized and that its     impact on the risk of heart disease may in fact be less important than originally thought.     This concept that dairy fat increases the risk of heart attacks therefore needs to be     revisited.      The proposed research is designed to investigate which risk factors for heart disease (e.g.     cholesterol, blood pressure) are beneficially modified when low fat (milk) and high fat     (cheese) dairy products are consumed.      Our hypotheses are : (1) Consumption of low fat dairy (milk 1% fat) compared with a     dairy-free control diet reduces daytime ambulatory systolic blood pressure and reduces     inflammation; (2) Consumption of a high fat dairy (GABA-rich cheese) compared with a     dairy-free control diet reduces daytime ambulatory systolic blood pressure and has favorable     effects on LDL particle size, inflammation and HDL-C concentration.   "
39874|NCT02763774|"     This study aims to analyze effects of three types of cardiac rehabilitation protocol on     fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after     coronary artery bypass grafting (CABG) in patients with left ventricular disfunction.     Patients will be randomized and allocated in three groups according to type of exercise     protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.   "
39875|NCT02763761|"     The purpose of this study is to compare the effects of Infliximab and oral prednisone versus     methylprednisolone and oral prednisone in patients with melanoma, lung cancer, or renal cell     carcinoma who have immune related Grade 3-4 diarrhea for up to 3 days or persistent Grade 2     diarrhea for more than 5 days after treatment with Yervoy and/or Opdivo   "
49598|NCT02636439|"     The purpose of this study is to examine the effects of weight loss via hypocaloric diet     (CR)and aerobic exercise (AT) compared to the effects of weight loss via hypocaloric diet     (CR), aerobic training (AT)and resistance training (RT).   "
39863|NCT02763917|"     Background: Asthma and obesity are public health crises that have concurrently risen over the     past decades, affecting millions of children in the United States and disproportionately     affecting low-income minority children in urban areas. The same children at highest risk for     asthma and obesity also have greater exposure to indoor and outdoor pollution. Emerging     evidence suggests that obesity may confer increased susceptibility to health effects of air     pollution.      Methods: Aiming to provide causal-level evidence of these observational findings, we propose     a home intervention study to 1) test whether targeted reductions of indoor Particulate Matter     (PM) concentrations improve the respiratory health of overweight inner-city children with     asthma more than that of lean inner-city children with asthma and 2) investigate mediators of     susceptibility to indoor PM among overweight versus lean children with asthma. We will     accomplish these aims using a 1:1 randomized controlled trial of 200 children with persistent     asthma (half normal weight, half overweight) living in Baltimore City. Participants will be     randomized to receive either two active air purifiers containing high-efficiency particulate     air (HEPA) filters or two sham air purifiers with their filters removed.      Implications: If the aforementioned observational findings are confirmed, implications will     be directly relevant to the over 170 million children around the world now estimated to be     overweight or obese.   "
39864|NCT02763904|"     Protein-calorie malnutrition is a frequent comorbidity in hospitalized patients and there is     evidence that the nutritional status may influence the response to drug treatment, mortality,     susceptibility to infections, the patient's functional status, duration of hospital stay and,     consequently, overall healthcare costs. The causes of malnutrition are manifold. The     underlying disease may in fact lead to an increase in the patient's energy needs, whether or     not associated with a reduction in caloric intake. The same therapeutic treatments can     further worsen the energy balance without considering that the patient can be kept fasting     for the execution of some diagnostic procedures. Therefore, a further deterioration of     nutritional status during hospitalization could occur.      International guidelines underline the utility to set a nutritional support whenever this is     necessary, not only to prevent or treat malnutrition but also improve clinical outcomes. In     this perspective, the improvement of oral diet and the use of oral nutritional supplements     (ONS) represent the first-line strategy of intervention. Previous studies have shown that     nutritional counseling, with or without the use of ONS, in patients with chronic disease is     able to improve the calorie-protein intake, prevent deterioration of nutritional status, as     well as to increase to a certain extent body weight. Particularly, energy-dense are more     effective in increase energy intake. These data have highlighted the importance of a proper     evaluation of the nutritional status of early detection of patients who could benefit of     nutritional support. However, the independent role of the ONS in improving clinical outcome     still needs to be established.   "
39867|NCT02763865|"     The purpose of this study is to determine the effects of Low Frequency Repetitive     Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on     tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET).      Hypothesis: Pre-SMA LF r-TMS will result in a >30% reduction in tremor as measured by the     TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the     pre-SMA effects tremor in patients with ET.      Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing     pre-SMA output, and improving motor control, as determined shortening of the delay in the     second agonist burst, seen in ET patients. At conclusion of this study expect to have     sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of     pre-SMA r-TMS in ET.   "
39868|NCT02763852|"     The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA     3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4     different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of     standard levodopa 100 mg/benserazide 25 mg (Madopar® 125) in adult male and female healthy     volunteers.   "
39869|NCT02763839|"     The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA     3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4     different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of     standard levodopa 100 mg/carbidopa 25 mg (Sinemet® 25/100) in adult male and female healthy     volunteers.   "
39870|NCT02763826|"     The purpose of this study is to determine the optimal transcranial direct current stimulation     (tDCS) amplitude and electrode montage that is both safe and efficacious   "
39871|NCT02763813|"     Monocentric comparative group study comparing the efficacy and short-term tolerance of a     propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the     treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be     equally effective and tolerated.   "
39872|NCT02763800|"     The objectives as stated in the study protocol were as follows:        -  To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202          (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male          volunteers). Part A        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA          3-202 in healthy young males. Part A        -  To investigate the safety and tolerability of a single multiple dose regimen (dose to be          determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single          multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy          elderly volunteers. Part B   "
39987|NCT02762214|"     Prospective multicentric randomized trial to evaluate the role of uterine manipulator on     laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial     cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).   "
39876|NCT02763748|"     Gastric stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation     potential, the incidence increased year by year. The surgical resection is the primary     treatment for it. Although laparoscopic GIST resection has many benefits，due to in lack of     the delicate sense of touch, it could lead to the incomplete resection and disorders of     digestion. More than 33% of postoperative patients have the gastric dysfunction. Laparoscopic     endoscopy combined surgery is different from the past technology. It is a new radical     resection of GIST presented by Japanese scholars. LECS resects the tumor completely by     laparoscopy with the help of the precise positioning and guidance of endoscopy .This method     conforms to the idea of the modern minimally invasive surgery, and avoids many problems，such     as incomplete resection and disorders of digestion caused by excessive tissue resection. our     team will spearhead the GIST treatment of LECS. First of all, the investigators will collect     120 cases of GIST patients, randomly assigned for the laparoscopic group, the LECS,     single-arch the LECS surgical treatment. Secondly, to analyzing the basic treatment and     follow-up data, including the operation time, blood loss, the number of transfer laparotomy,     the number of cut edge positive, the distances of cut edge away from the tumor edge, the     cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time,     cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and     frequency, reflux esophagitis, bile reflux gastritis and other indicators.The purpose of this     subject is to observe the effectivity and safety of LECS and single-arch the LECS, invent     serval LECS equipment patents and provide some references for LECS applying to the minimally     invasive surgery of the digestive tract tumor and multidisciplinary treatment mode .   "
39877|NCT02763735|"     The purpose of this study is to use non-invasive imaging to determine the metabolic phenotype     of the right ventricle in patients with pulmonary arterial hypertension across a spectrum of     disease severity.   "
39878|NCT02763722|"     Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease that has potential     for profound and far-reaching effects on all aspects of children and their families lives,     significantly reducing the quality of life. Atopic dermatitis typically appears in infancy     and nowadays is affecting up to 10-30% of children and 2-10% of adults.      Diminished skin barrier is the essential factor that plays a role in the initiation,     consolidating and exacerbating AD. Treatment options for AD typically address skin barrier     protection or inflammatory components of disease. Proper care using mild and appropriately     formulated emollient preparations may provide significant benefits.      In investigators prior study, more than half of pharmacy-derived emollient preparations     contained potential contact haptens listed in the European baseline series (EBS), used in     diagnosing contact dermatitis.      The primary aim of this study is to demonstrate the efficacy of regularly applied emollient     in an atomiser (in the form of oil-in-water emulsion) in maintenance therapy, in children     presenting from mild to moderate atopic dermatitis.      In this study 3 visits are planned (for a period of 4 weeks). During each visit investigators     will evaluate transepidermal water loss (TEWL), capacitance of outer areas of the stratum     corneum as an indirect assessment of skin hydration. Moreover, investigators will assess     three-them-severityIndex and the Children's Dermatology Life Quality Index (CDLQI).      The product that participants will use in the study, was prepared at investigators request,     in collaboration with the cosmetics company, which according to investigators knowledge at     present, will not be benefited from the audit. The following described study project     (prospective clinical trial, uncontrolled, open-label) will be conducted within the framework     of the statutory tasks of the Department of Pulmonology and Allergology of Children Medical     University of Warsaw and is a non-commercial project.   "
39879|NCT02763709|"     Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders     characterized by generalized weakness developing after the onset of critical illness.     Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case     series of no more than five children. Critical illness polyneuropathy is characterized by     reduction in compound motor action potential or sensory nerve action potential or both with     preserved conduction velocity on electrophysiological studies. These findings can occur very     early prior to the onset of clinical features. Given the dearth of data in children on the     subject, this study has been planned to evaluate the incidence of critical illness associated     polyneuropathy /myopathy in severely sick children admitted.   "
39880|NCT02763696|"     The vaginal microbiota is an important biological barrier for host against pathogens or     opportunistic pathogens. Undermining the balance of the vagina is closely related to     infectious diseases and tumors.      The vaginal microbiota of child-bearing women of age is dominated by Lactobacillus species,     including major four species: Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus     gasseri and Lactobacillus iners, followed by obligate anaerobes such as Gardnerella     vaginalis, Atopobium vaginae, Mobiluncus curtisii, and Prevotella .      Currently, There are almost 99% bacteria can not to be found with bacterial culture. Based on     microscopy and conventional culture method to obtain vaginal microflora information have a     variety of deviation. For this reason, The in-depth study of complex vaginal flora and the     correct understanding of disease faces a serious obstacle. With the development of     High-throughput sequencing technology， metagenomics can get all the composition and     distribution of microorganisms from the sample which traditional knowledge may not be with     microorganism culture method. Therefore, Re-evaluation of existing microflora diagnostic     criteria for clinical diagnosis of the disease is necessary.      In this study, the investigators use high-throughput sequencing technology to detect women of     childbearing age vaginal microflora of metagenomic distribution. Including bacteria, fungi,     viruses, protozoa, and other microorganisms. Based on the study results of metagenomic, the     investigators want to re-cognition thenormal floraof women of childbearing age ,and develop     vaginal microflora microscopic evaluation of the integrity of the reference standard.   "
39881|NCT02763683|"     The purpose of this study is to use a brain imaging method called Pittsburgh B (PIB) Positron     Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET to determine dementia     subtypes in patients with Parkinson's disease. The ultimate goal of this project is to be     able to identify individuals with PD who are at risk of developing dementia, and to     distinguish the underlying cause of dementia.   "
39882|NCT02763670|"     The heart failure is a chronic pathology with prevalence from 2 to 3% of general population,     a death rate of 50% at 6 months for patients with stage IV, and a probability of death or     hospitalization or emergency consultation of 40% at 3 years. The care of patients is     heterogeneous, especially in light of the organization of therapeutic education offered to     patients and patient monitoring modalities.      The aim of this study is to investigate the management strategies for patients with chronic     heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with     previous hospitalization for heart failure.      This is a longitudinal observational multicenter study comparing a management strategy     including patient education and monitoring as part of a hospital dedicated organization and     an organization of care as usually done in France.      The primary endpoint was a composite endpoint of morbidity and mortality involving deaths,     unplanned readmissions and emergency visits for heart failure.      The expected number of patients is 720 patients (360 per strategy). The follow-up duration of     24 months.   "
46903|NCT02671682|"     This observational study investigates the efficacy and safety of immunoadsorption versus     plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated     syndrome who do not fully recover after a high doses of intravenous corticosteroids.   "
39883|NCT02763657|"     Children's understanding of linear-order (e.g., Dan is taller than Lisa, Lisa is taller than     Jess) and set-inclusion (i.e., All tulips are flowers, All flowers are plants) relationships     is critical for the acquisition of deductive reasoning, that is, the ability to reach     logically valid conclusions from given premises. Behavioral and neuroimaging studies in     adults suggest processing differences between these relations: While arguments that involve     linear-orders may be preferentially associated with spatial processing, arguments that     involve set-inclusions may be preferentially associated with verbal processing. In this     study, we use functional magnetic resonance imaging to investigate how and when these     processing differences appear in children from 8 to 14.   "
39884|NCT02763644|"     This is a randomized, SoC-controlled, open-label, multi-center study in patients with TAM     after hematopoietic precursor cell transplantation (HPCT) .      Study will consist of up to 28 days of screening period, 16 weeks treatment period that can     be extended to 45 weeks.Approximately 40 patients will be randomized to receive SoC or LFG316     plus SoC. Patients will be included in the study if they have diagnosis of TAM and poor     prognostic markers.   "
39885|NCT02763631|"     The aim of this study is to assess the benefit of a portable ventilator generating positive     end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway     collapse (EDAC) and tracheobronchomalacia (TBM).   "
39886|NCT02763618|"     This study will investigate the effects of an EEG theta/beta ratio Neurofeedback training     using a case series multiple baseline design. Twelve participants will be assigned to one of     three different groups that have a different time of intervention onset, or include placebo     sessions only. The investigators will examine whether the theta/beta ratio Neurofeedback     training will reduce resting state theta/beta ratio. As a pilot-exploration for future     studies, also performance on a cognitive interference task will be monitored to see if any     improvement after NFT on cognitive performance might be a viable subject for future studies.     All participants (healthy, but selected for above-median theta/beta ratio in previous studies     in this lab) will start with three resting state EEG baseline sessions, the first participant     group then continues with 14 theta/beta ratio Neurofeedback sessions, the second group     continues with six extra baseline EEG measurements, followed by eight Neurofeedback training     sessions while the third group will continue with 14 placebo training sessions only. EEG     resting state theta/beta ratio and interference performance will be measured during every     session.   "
39908|NCT02763241|"     The investigators proposed that the Cleanoze® is superior to the traditional nasal saline     irrigation in term of the ease of use which will resulting in a better quality of life of the     participants. This study will compared the efficacy, adverse reactions, complications and     ease of use of Cleanoze® comparing with normal saline solution   "
39909|NCT02763228|"     The purpose of this research study is to determine whether a physical activity (exercise)     program in the community will improve the functional and overall health status of older women     with a history of breast cancer. The physical activity or exercise program is designed for     all older breast cancer survivors, and in particular for African-Americans and women of lower     socio-economic status, who are the least likely to engage in physical activity.   "
39887|NCT02763605|"     Acanthamoebic keratitis is an important corneal disease which may cause severe complication.     The difficulty in diagnosis, the difficulty in treatment, and the long treatment process are     factors leading to the poor prognosis of these patients. In this retrospective study, the     investigators try to analyze the tissue proven Acanthamoebic keratitis diagnosed in our     hospital. The investigators will focus on the in vivo confocal microscopic results, the     medical history and the medical/surgical treatment outcome. The investigators will collect     the tissue proven cases according to the data provided by laboratory diagnosis department and     pathological department. The in vivo confocal microscopic results will be collected and     analyzed. The investigators will also look through the photography of the external eyes from     data stored in PAC system. The medical history and treatment outcome will be studied from     clinical chart review. From this study, the investigators aimed to find out a easy way of     diagnosing Acanthamoebic keratitis from in vivo confocal microscopy, and find out a better     way for treatment.   "
39888|NCT02763592|"     The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on     allodynic symptoms of localized neuropathic pain after knee surgery.   "
39889|NCT02763579|"     This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study is     designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1     [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment     with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.     Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin +     etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the     induction phase followed by maintenance with atezolizumab or placebo until progressive     disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid     Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD     or symptomatic deterioration.   "
39890|NCT02763566|"     The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in     postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor     receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.   "
39891|NCT02763553|"     The purpose of this study is to assess if an enteral ketogenic feed will cause a ketotic     state in critically ill patients on intensive care.   "
39892|NCT02763462|"     This study is an observational cohort study of hospitalized patients with fever. This study     will collect demographic data, history of illness, signs and symptoms, results of laboratory     tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND     hospitals. Potential study patients will be any patients (both children and adults).   "
39893|NCT02763449|"     The purpose of this study is to understand what happens when someone either becomes more     active or more inactive. This study will measure your energy intake, energy expenditure, and     body composition under normal conditions, when you become active, and when you become     inactive.   "
39902|NCT02763332|"     The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear     the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the     central and autonomic nervous systems, neurotransmitters, hormones, immune system, external     stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly     expressed by the people who suffer from it is pain.      The main goal of the present study is to analyse the effect of the kinesiotaping on the pain,     comfort and postural position of the patient with fibromyalgia.   "
39903|NCT02763319|"     The purpose of the study is to compare the safety and efficacy of MOR208 with BEN versus RTX     with BEN in adult patients with relapsed of refractory DLBCL.   "
39988|NCT02762201|"     This study aims to compare the therapeutic efficiency of implant-secured removable partial     denture (PASI) with the therapeutic efficiency of the metalic standard removable partial     denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The     therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.   "
39894|NCT02763436|"     The first major intervention a newborn infant is facing following birth is clamping of the     umbilical cord. This means separation of the infant from the placenta, the newborn becomes an     independent individual, especially from a cardio-circulatory perspective. Recent literature     focused very much on the appropriate timing of the cord clamping (CC), distinguishing     immediate cord clamping (ICC) from delayed cord clamping (DCC). Although potential benefits     for DCC have been documented, especially for preterm infants, ICC still is the most widely     used procedure. Although the reasons for this are unclear, a lack of understanding of the     issues associated with umbilical cord clamping is thought to be a major underlying factor.      In animal research with fetal lambs it has been shown, that aeration of the lung played a     crucial role in undisturbed cardio-circulatory immediate neonatal transition. Thus a new     concept of DCC was introduced, delaying cord clamping until ventilation/aeration of the lung     was established, calling this Physiological-Based Cord Clamping (PBCC). It was shown, that     PBCC improved not only cardiovascular function in preterm lambs, but systemic and cerebral     oxygenation too. Systemic oxygenation was measured using pulseoximetry, and cerebral     oxygenation was measured using near infrared spectroscopy (NIRS).      Until now, human data for PBCC are lacking. Therefore, the aim of the present study is to     investigate whether PBCC is able to improve systemic and cerebral oxygenation in term infants     delivered vaginally.   "
39895|NCT02763423|"     This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within     the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The     purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell     transplantation is effective in the treatment of patients with severe type 1 diabetes.   "
39946|NCT02762747|"     This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal     hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups     by an independent assessor clinically and radiologist to document the size of seroma after     surgery. Other secondary outcomes will be measured including post-operative pain, discomfort,     analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.   "
39965|NCT02762500|"     The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally     once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score     (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1     at screening.   "
39896|NCT02763410|"     Safety during transfusions is a major issue in medical economics. Despite drastic quality     control measures, transfusion is still a source of short, mid and long-term morbi-mortality.     This can be explained to some extent by changes in the composition of the packed red blood     cell (PRBC) supernatant during storage essentially with the appearance of immunologically     active compounds possibly involved in organ dysfunction on the one hand and post-transfusion     immunomodulation on the other hand. These phenomena impact upon outcomes for cardiac surgery     patients.      In terms of organ dysfunction, kidney failure due to acute tubular necrosis and pulmonary     failure are the 2 main issues. Following cardiac surgery, 11% of patients will present with     transient renal dysfunction characterised by a 25% increase in serum creatinine levels and     3.5% require dialysis. The intensity of acute renal failure (ARF) is correlated to     resuscitation : a 20% increase in serum creatinine levels 2 to 3 days after surgery     significantly raises morbidity rates and a 50% increase raises the mortality rate to 10%.      The precise mechanisms governing post-transfusion immunomodulation have not yet to be     defined. The appearance of soluble type I Human leukocytes Antigen (HLA) molecules (sHLA-I),     the FAS ligand (FAS-L) or cluster designation 40 (CD40-L) in the supernatant of PRBCs along     the storage of blood products may be involved in such phenomena. These molecules are capable     of activating or triggering the death of innate or adaptive immunity cells, especially the     Natural Killer (NK) cells.      Consequently the investigators propose to focus specifically on the detailed composition of     transfused PRBC supernatants in order to identify the candidate molecules responsible for     organ dysfunction or post-transfusion immunoparalysis. The investigators will combine a     clinical approach based on the transcriptional analysis of renal tubular cells in transfused     patients and an ex-vivo approach investigating the effect of the supernatant on immune cells     and the Natural Killer cells of healthy volunteers   "
39897|NCT02763397|"     The existing DBS setting in patients with DBS of the globus pallidus interna (GPi), which     aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed     to stimulate the NbM at a low frequency using the distal electrodes positioned in the     vicinity of the NBM.      This study aims to investigate the neuropsychological effect of low frequency stimulation of     the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were     previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).   "
39898|NCT02763384|"     The outcome of patients with relapsed or refractory adult T-acute lymphoblastic leukemia     (T-ALL) and the related disease T-lymphoblastic lymphoma (T-LBL) is extremely poor with 30%     of the patients responding to first salvage therapy and long-term survival of only 10%.     Therefore, novel therapies for patients with relapsed/refractory T-ALL/LBL represent an unmet     clinical need.      Recent data provide strong evidence that CXCR4 signaling plays a major role in T-cell     leukemia cell maintenance and leukemia initiating activity, and targeting CXCR4 signaling in     T-ALL cells reduces tumor growth in an animal model. In this study, the investigators propose     that the addition of BL-8040 to nelarabine as a salvage therapy for patients with     relapsed/refractory T-ALL/LBL will result in a higher CR rate than nelarabine alone without     an increase in toxicity and will allow patients to proceed to a potentially curative     allogeneic hematopoietic cell transplant.   "
39899|NCT02763371|"     The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study     Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch     versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive     functions in the afternoon. The The Cognition Intervention Study Dortmund Continued (Coco)     connected this two previous studies and investigates the effect of having school lunch versus     skipping it on children's basal and executive cognitive functions later in the afternoon. The     present study the Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) examines     the influence of the gylcemic index of lunch on cognitive performance of school children in     the afternoon.   "
39900|NCT02763358|"     This study is designed to test the usability of the Bite Counter in an attempt to reduce     participants' daily bites while also increasing their daily steps.   "
39901|NCT02763345|"     Community Case Management (CCM) is a clinical decision aid used by frontline Health     Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and     malaria (amongst other conditions). Children identified has having complicated illness are     urgently referred to larger health facilities better equipped to clinically manage these more     complex presentations. There is evidence to suggest HSAs are missing opportunities to refer     seriously ill children, and parents/caregivers are failing to comply with urgent referral     recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of     mobile technology for deploying CCM has been demonstrated in prior research as feasible to     evaluate, acceptable to health workers and parents/caregivers and improving health worker     fidelity to the guidelines, but it is unknown if this translates into increased referral and     referral completion rates. This trial seeks to evaluate the added value of a purpose     developed mobile solution for CCM, called Supporting LIFE electronic Community Case     Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.   "
40000|NCT02762045|"     This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to     evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects     receiving stable highly active antiretroviral therapy(HAART) .   "
39904|NCT02763293|"     Crohn's disease (CD) is an inflammatory bowel disease with a high prevalence. Its etiology is     unknown and is considered a multifactorial disease. It is known that the existence of a     genetic factor, industrialization and development of the country and environmental factors     have great influence on the appearance of intestinal pathology (the Val; Buderus; Molodecky).     CD is a chronic inflammatory bowel disease localized throughout the course of the digestive     tract (oral-anal). The aim of this study is to evaluate the effect of a treatment program     combining technical nonmanipulative appropriate in affected patients (CD) to increase the     overall quality of life and related EC, lower abdominal pain direct and indirect osteopathic     soft, observe the sense of change after treatment, and psychological aspects.   "
39905|NCT02763280|"     Recently, osteoporosis has been recognized as a serious health problem in the elderly, it has     also increased in young • middle-aged layer. Ginseng is history 2, 000 years Korean typical     herbal medicine which is used as a medicinal is known the mystery of Elixir from a long time     ago. A previous study was administered ginseng extract results in animal models induced     osteoporosis, the bone-related biomarkers, including improved bone density and bone mass.   "
39906|NCT02763267|"     It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes     Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or     whether it is the result of an imbalance of a placental hormones. Undiscovered placental     factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To     elucidate the pathophysiology underlying GDM, the investigators will attempt to discover     these factors and characterize pregnancy-associated changes in insulin secretion and     sensitivity in women with and without GDM.   "
39910|NCT02763215|"     This is a 24-month study to assess copper (Cu) parameters in subjects with Wilson Disease     treated with standard of care (SOC) medications. Data will be collected during routinely     scheduled Wilson Disease clinic visits at approximately 6-month intervals.      After providing informed consent, subjects meeting all inclusion and no exclusion criteria     will be enrolled into the study as outpatients. Subject's routine Wilson Disease clinic     visits will be scheduled according to the standard clinical practice at the study center and     at the discretion of the treating physician at approximate 6-month intervals.      At the time of enrollment, subjects will be receiving SOC therapeutic agents for the     treatment of Wilson Disease. If treatment is interrupted or stopped during the course of the     study, subjects will continue in the study and biological samples and clinical data will     continue to be collected for the full 24-month study period. Dosing with SOC agents, which     can include penicillamine, trientine, zinc, or a combination of a Cu chelator and zinc, will     be individualized and managed by the treating physician at the study center according to     standard clinical practice at the site.   "
39911|NCT02763202|"     The purpose of this study is to better enhance transitions of care for the highest risk,     complex patients, Carolinas HealthCare System (CHS) has designed an Integrated Practice Unit,     called Transition Services (CHS-TS).CHS-TS aims to improve patient outcomes through     innovative approaches that leverage analytics and technology, while bridging care     coordination and communication gaps. During their hospitalization, CHS-TS patients enter into     a transition pathway that includes the following key services: integrated access to medical,     pharmacist, and specialty providers; access to CHS disease specific management programs;     dedicated care management services delivered in home and at the clinic; lab and infusion     services; palliative care consultations when appropriate; and paramedicine for 24 hour     support. AIRTIGHT (Aiming to Improve Readmissions Through InteGrated Hospital Transitions) is     a pragmatic, randomized quality improvement evaluation, which seeks to evaluate the effects     of the role-out of CHS-TS services for patients at high risk for a 30-day readmission.     AIRTIGHT will test the hypothesis that patients that receive care through CHS-TS will have a     lower all cause, 30-day readmission rate than patients that receive usual care.   "
39912|NCT02763189|"     The purpose of this pilot study is to compare the time it takes to change a breathing tube     with a new device, performed by two different groups of anesthesiologists; one group will     study on their own how to change the tube, while the second group will also receive expert     training, before either group performs the procedure for the very first time. The     Investigators predict the group who gets expert training will change the tube faster, and     those investigators also need to learn how much faster, before moving to a larger study.   "
39913|NCT02763176|"     This study seeks to assess trends in hCG between the 9th and 12th weeks of gestation. Women     presenting at prenatal care at the study site who are 70 days gestation or less will be     offered participation in the study. 75 consenting women will be asked to provide urine for an     MLPT and to have blood drawn for hCG serum testing at 56-63 days, 64-70 days, and 71-77 days'     gestation, and 75 consenting women will be asked to provide urine for an MLPT and to have     blood drawn for hCG serum testing at 64-70 days, 71-77 days, and 78-84 days' gestation.   "
39924|NCT02763033|"     Investigators are evaluating the feasibility, safety and early efficacy of administering a     commercially available dietary supplement containing potato-based resistant starch to     subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin     immediately prior to the conditioning phase and continue through day 100. Investigators     hypothesize that short term administration of a resistant starch is capable of increasing     levels of butyrate within the intestine that will reduce rates of acute GVHD     (Graft-Versus-Host Disease).   "
39914|NCT02763163|"     These days many studies are conducted testing the symbiosis between the bacteria population     to the human body's functioning. The research of the connection between the skin condition     and the bacteria population is in its early stages. There is a characterization of different     bacteria for different body areas depending on their composition, humidity etc. In addition,     there are preliminary findings of biological receptors that react to the contact with     bacteria on the surface of the skin and turn on the immune system, awakening it to cope with     the new invader. Based on the above information, the investigators hypothesis is that there     is a connection between the degrees of sun exposure of individuals to the growing of     beneficial bacteria populations on the surface of the skin. The study will compare between     the bacteria population on the skin of Israeli subjects, divided to two groups, one with an     excessive exposure to the sun on a daily basis, (such as agricultural workers, lifeguards,     construction, etc.), and the other of the office worker who spend most of the day in a closed     shaded room.   "
39915|NCT02763150|"     The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle     intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women     with overweight or obesity.   "
39916|NCT02763137|"     This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and     efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD)     vs.semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced     Parkinson's disease (PD) who suffer motor fluctuations.The objective of this study is to     assess the plasma pharmacokinetics (PK) of continuous intra-oral administration of LD/CD vs.     intermittent administration of standard oral LD/CD. For purposes of this study continuous     intra-oral administration of LD/CD is defined as oral administration of LD/CD at 5-10 minute     intervals.      Secondary objectives are to assess the safety and tolerability of continuous intra-oral     administration of LD/CD and the effect on PD motor function of continuous intra-oral     administration of LD/CD vs. intermittent administration of standard oral LD/CD.   "
39917|NCT02763124|"     To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce     astigmatism in a pseudophakic population.   "
39918|NCT02763111|"     BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal     antibody to interleukin 17. During BCD-085-2 trial patients with active ankylosing     spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6,     8, 10, 12. Efficacy and safety parameters will be evaluated.   "
39966|NCT02762487|"     The purpose of this study is to evaluate the LINX device in patients who have previously     undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal     reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.   "
39919|NCT02763098|"     Effects of different doses of remifentanil on hemodynamic response to anesthesia induction in     elderly patients ABSTRACT OBJECTİVE: The investigators compared the effects of three     different doses of remifentanil infusion, which have been performed for the induction of     anesthesia in elder patients, on cardiovascular response.      PATIENTS AND METHODS: The present study was designed as a randomized, prospective and     double-blind study. A total of 90 ASA I-II patients over the age of 65 years were enrolled     and each group consisted of 30 subjects. The patients were randomly (by lot) assigned to     receive one of the three doses of remifentanil infusion (0.1, 0.2 or 0.3 µg/kg/min) for two     minutes. Subsequently, 0.5 mg/kg propofol was administered via IV route and, 0.5 mg/kg     rocuronium was administered via IV route at the time eyelash reflex disappeared. Intubation     was performed after two minutes. After recording baseline values of heart rate (HR), systolic     arterial pressure (SBP), diastolic arterial pressure (DBP) and mean arterial pressure (MAP),     these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of induction.   "
39920|NCT02763085|"     Evaluation of a new basic filling restorative material.      In contemporary dentistry, clinicians have essentially three types of material choices for     direct restorations: amalgam, resin composite, and glass ionomer restoratives.      Due to the toxicity of mercury and the subsequent environmental problems, the search for     alternatives continues and search into new composite restorative materials intensifies.     Recognized disadvantages of tooth colored resin based restorative materials are as     polymerization shrinkage, postoperative sensitivity and technical procedure complexity.     Higher rates of occlusal wear and lower toughness are disadvantages of glass ionomer     restoratives.      Therefore, alternative materials are being developed to compensate the disadvantages of     current contemporary tooth coloured restorative materials. Nevertheless, the search for     simplification for restoring missing dental tissues introduced the basic filling concept.      This project aims to study the clinical performance of this new basic filling restorative     material for Class I and Class II cavities. 80 patients are recruited to the project which is     carried out at the School of dentistry, Istanbul Medipol University, Turkey.   "
39921|NCT02763072|"     The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of     two laser systems for improvement of lentigines on the hands.   "
39922|NCT02763059|"     Background and aim: Postoperative pain is an adverse effect of oral surgeries and may     therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen     and dexamethasone protocols in pain prevention and control after surgical implant placement.      Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized     clinical trial, 117 dental implants were placed. The groups received three different     protocols 1 hour before surgery:        1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);        2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or        3. placebo.      Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to     take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and     visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate     scale, hourly for the first 8 hours after surgery and three times a day on the following 3     days.   "
39923|NCT02763046|"     The current study will assess the clinical Assessment of SpondyloArthritis international     Society (ASAS) 20 response to Secukinumab and evaluate to which extent concomitant     nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with     Secukinumab or placebo following an initial run-in phase of stable NSAID therapy. In case of     a positive outcome concerning the NSAID reduction this study could trigger the development of     a guidance concerning NSAID reduction applicable for all Ankylosing Spondylitis (AS) patients     starting a biologic treatment.   "
39955|NCT02762630|"     Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess     normal alignment of the knee joint   "
39925|NCT02763020|"     Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health     that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to     determine whether the fortification of a high sugar food item with a polyphenol-rich     freeze-dried fruit and/or a fruit extract improves blood sugar response and promotes other     positive physiological changes (e.g., satiety) in a dose-response manner. This study will     test four different types of snack bar with various polyphenol doses, and compare blood     response to a snack bar without polyphenols.   "
39926|NCT02763007|"     Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open     label extension trial for 28 weeks followed by 2 year observational study.   "
39927|NCT02762994|"     BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal     antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque     psoriasis, in whom poor response to previous treatment including UV-therapy and biologic     drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1,     2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.   "
39928|NCT02762981|"     The purpose of this study is to assess the safety of the combination of CORT125134, a novel     glucocorticoid receptor (GR) antagonist, and nab-paclitaxel in patients with solid tumors and     to determine the preliminary efficacy of the combination of CORT125134 and nab-paclitaxel in     patients with solid tumors. The structure for the study is a single arm, non-randomized,     open-label, multicenter trial with no control group. The study will be conducted at     approximately 8 sites with approximately 82 evaluable patients.   "
39929|NCT02762968|"     The study will determine whether acute ingestion of a probiotic combined with     beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers     during 8-weeks of advanced infantry training.   "
39930|NCT02762955|"     CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy,     safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD,     Russia) and Humira® when used in patients with moderate to severe plaque psoriasis.   "
39931|NCT02762942|"     Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal     misoprostol for induction of labour, vaginal delivery is achieved in less time compared with     vaginal misoprostol alone.   "
39932|NCT02762929|"     A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of     Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy   "
39933|NCT02762916|"     The current increase in chronic diseases calls for changes to the health system. It is     necessary to promote expert patient in chronic disease. The expansion of new technologies     gives us new tools to face new challenges, providing efficiency, expertise and autonomy. The     characteristics of peripheral arterial disease make possible to promote expert patient and     the self-management. In order to bring these concepts together the telemedicine program was     created to promote expert patient for increasing the quality of life and satisfaction of     patients and improving the efficiency of the health system.      Methods: Randomized clinical trial on patients with peripheral arterial disease in     intermittent claudication grade. They were randomized into two groups: intervention arm (IA)     using CONTECI program for self-managing and control arm (CA), followed as usual vascular     visits.   "
39934|NCT02762903|"     The primary objective of this study is to assess the clinical effectiveness of two different     techniques used for subscapularis tendon repair during total shoulder replacement. The     investigators hypothesize that participants who receive a newer repair technique called a     lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle     dysfunction and rupture as compared to those who receive the traditional tenotomy repair.   "
39935|NCT02762890|"     The purpose of this study is to investigate and compare the postoperative quality of recovery     between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic     gastrectomy.   "
39936|NCT02762877|"     A study to determine the concordance of key actionable genomic alterations as assessed in     tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)   "
39937|NCT02762864|"     To compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change     in        1. time of initial leg pain and time of termination of exercise test by pain, evaluated on          the graded stationary bicycle test,        2. the lower limb perfusion by using MRI blood oxygenation-level dependent (BOLD) and          dynamic contrast enhancement sequences and measures the extracellular volume fraction          (ECV) as an indicator of fibrosis severity in calf muscles, from one to 52 weeks          post-revascularization in patients with peripheral artery disease who have undergone          endovascular revascularization -/+ bypass surgery for moderate to severe claudication or          ischemic rest pain.   "
39938|NCT02762851|"     A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular     events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or     placebo and followed prospectively over three influenza seasons. 3,500 participants will be     enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo,     either of which they will receive annually for three years and then followed over each of the     influenza seasons.   "
39939|NCT02762838|"     BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of     efficacy and safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in combination with     methotrexate in patients with active rheumatoid arthritis.   "
39956|NCT02762617|"     This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will     examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate     (TDF) vaginal ring when used continuously for 84 consecutive days by sexually active women.      The primary objective is to assess the safety of TDF vaginal rings when used continuously for     84 days by healthy, HIV-uninfected, sexually active women, as compared with a placebo vaginal     ring.   "
39957|NCT02762604|"     The investigators propose a single-blind randomized clinical trial to determine if seniors     show improved mobility (walking speed) and cognition following motor imagery (imagined     walking) training. They hypothesize that imagined walking can be used as a rehabilitative     tool for improving walking speed and cognition in the elderly, because it engages and     strengthens similar neural systems as actual walking and cognition.   "
39940|NCT02762825|"     Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and     mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to be     consistently beneficial in treating these problems. However, increasing evidence suggests     that exercise training is effective for both partially reversing exercise intolerance and     improving quality of life in these patients. Most such trials to date have been conducted in     controlled research setting, versus integrating these patients in to a standard CR program.     Also, since functional capacity is related to outcomes in these patients, exercise strategies     aimed at further improving fitness are warranted. One such strategy is using higher intensity     interval training (HIIT) in the CR setting, a strategy shown to be effective in patients with     other types of CVD. This project is designed to test the feasibility of incorporating these     patients into the CR setting, and training them using a methodology (i.e., HIIT) already     shown to yield (in other patients with CVD) greater gains in fitness when compared to what     was achieved using standard MCT alone.   "
39941|NCT02762812|"     BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to     evaluate efficacy and safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in patients with     ankylosing spondylitis.      BCD-055 is biosimilar of infliximab (JSC BIOCAD, Russia)   "
39942|NCT02762799|"     BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety     of single-injection of Leucostim® to healthy volunteers compared to Neupogen®   "
39943|NCT02762786|"     This study aims to examine the effectiveness of musical training in in improving the     psychological well-being, in particular their self-esteem, depression, happiness and quality     of life of children from low income families.Half of the participants will receive weekly     one-hour lessons on musical training for 12 weeks, while the other half are the placebo     controls.   "
39944|NCT02762773|"     The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus     sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain     control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.   "
39945|NCT02762760|"     This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with     pain due to osteoarthritis of the basal thumb joint.   "
39967|NCT02762474|"     This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for     unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy     regimen for local advanced and unresectable esophageal cancer patients.   "
39947|NCT02762734|"     MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt:     it is based on the sending of SMS (or mail or other new media), over a period of 6 months     after their suicide attempt (SA), in order to allow them to recourse to the care more easily     and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter     controlled randomized trial (East of France) and there is a funding from the Hospital. The     proposal trial will test the hypothesis that adolescent suicide attempters who are receiving     SMS (or mail or other new media) from the unit of care in addition to the usual care will do     less SA recurrence, than those who are receiving the usual care.      The primary objective is to determine whether the use of SMS (or mail or other new media) to     keep in touch with adolescent suicide attempters in addition to the usual care, compare to     usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the     SA.   "
39948|NCT02762721|"     The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived     intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA)     tumor samples   "
39949|NCT02762708|"     What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2     diabetes outside of weight loss alone?   "
39950|NCT02762695|"     The purpose of this study is to evaluate whether a new model of health care for chronic     patients, based on Case Management and guided by a nurse which targets the patient´s risk, is     more effective than usual care at Primary Health care in Chile. Additionally, this     intervention would provide a better quality of care and a more efficient health provision.   "
39951|NCT02762682|"     PRIMARY OBJECTIVES      • To describe the vitamin B12 status in children with infantile tremor syndrome(ITS) and Pre     ITS      SECONDARY OBJECTIVES        -  To study the vitamin B12 status in mothers of children with infantile tremor syndrome          (ITS) and Pre ITS        -  To study the blood levels of folate in children with infantile tremor syndrome (includes          Pre ITS) and their mothers.   "
39952|NCT02762669|"     Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity worldwide,     and is caused most commonly by poor uterine muscle contraction after delivery of the baby and     placenta. The first line agent used in the prevention and treatment of PPH is oxytocin, which     acts by binding with the oxytocin receptor (OTR) found on myometrial cells to cause uterine     contraction.      Oxytocin is also used for the augmentation of labor when spontaneous labor has been deemed     ineffective. It is administered intravenously at progressively higher doses, until effective     contractions are achieved and vaginal delivery results. However, if augmentation is     determined to have failed, a Cesarean delivery (CD) is performed.      One of the potential problems with oxytocin use during delivery is that it loses its     effectiveness if the uterus has previously been pre-exposed to its high doses and/or for a     prolonged duration during labor. This phenomenon is termed OTR desensitization, and can     result in the attenuation of myometrial contractility induced by subsequent oxytocin     administration, as well as PPH due to poor uterine tone. Furthermore, oxytocin can produce     potentially fatal maternal hemodynamic adverse effects when administered at high doses, so it     is advantageous to be able to use as low a dose as possible to obtain good uterine muscle     tone.      The objective of this study is to get a better understanding of the signaling pathways     governing desensitization, resensitization and contractility in pregnant human myometrium.     The investigators wish to investigate the effects of increasing recovery period on the     expression patterns of the OTR and its signaling pathways in desensitized pregnant human     myometrium.      This study will help shed light on the molecular mechanisms responsible for desensitization     and oxytocin-induced myometrial contractility, and will provide some insight into potential     therapeutic targets to reduce the incidence of PPH and complications associated with using     increasing concentrations of oxytocin.      The hypothesis is that the expression and phosphorylation patterns of the OTR and downstream     proteins will be altered in desensitized myometrium, and that these patterns will change with     increasing rest periods and re-exposure to oxytocin.   "
39953|NCT02762656|"     The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine     intravenous infusion in reducing postoperative pain for spine surgery patients.   "
39954|NCT02762643|"     A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics     of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each     component administered alone in healthy male volunteers.   "
39961|NCT02762552|"     In acute ischemic stroke, the identification of an etiology is of major importance to prevent     recurrence by providing the best treatment. Because of numerous possible underlying     etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic     tests, which can be invasive, long and expensive. Moreover, many patients receive a diagnosis     of undetermined stroke even after all available diagnosis tests are done, precluding optimal     treatment.   "
39962|NCT02762539|"     Traumatic brain injury (TBI) is major health problem that stands as a significant cause of     death and permanent disability. TBI is considered as global public health epidemic. On     pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary.     Once a primary insult occurs like trauma or ischemia, the secondary injury begins though main     four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3 PUFAs     (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the     ability to impact all four main mechanisms of the secondary injury Patients will be allocated     into one of two groups through a random table generation; Control group in which patients     will follow our local protocol for TBI management without SMOF-lipid infusion. SMOF-lipid     group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for     intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive     oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days   "
39963|NCT02762526|"     Background: The lipoabdominoplasty can lead to respiratory complications in the postoperative     period becoming critical early clinical and functional evaluation of respiratory muscles,     seeking to direct a more effective treatment, which can result in shorter hospital stays and     lower spending on health in patients undergoing such procedures. Objective: To evaluate the     correlation of regional distribution of ventilation system with thoracoabdominal     diaphragmatic mobility in women undergoing surgery lipoabdominoplasty comparing preoperative,     10 ° and 30 ° DPO DPO. Methods: This is a prospective cohort study, which will be evaluated     30 women aged 25 to 55 years undergoing lipoabdominoplasty surgery without respiratory or     prior cardiac comorbidities and body mass index (BMI) ≤ 30 kg / cm2. women smokers are     deleted and / or a history of smoking more than 10 years and unable to understand the     commands to perform the proposed methods. For evaluation of diaphragmatic mobility will be     used high-resolution ultrasound with convex 3.5 MHz transducer. The evaluation of the     regional distribution of ventilation thoracoabdominal system will be made using the     optoelectronic plethysmograph (POE). The strength of the inspiratory and expiratory muscles     is measured through a digital manometer connected to a nozzle with an orifice of 2 mm to     reduce the closing pressure of the glottis. A portable spirometer is used for assessment of     pulmonary function and evaluation of dyspnea will be used modified Borg scale. The data will     be evaluated in the preoperative period, 10 days and 30 days postoperatively. Hypotheses:     Patients undergoing surgery lipoabdominoplasty have decreased diaphragmatic mobility,     strength and respiratory function, in addition to presenting changes in the pattern of     regional ventilation distribution in torocoabdominal system in the postoperative period when     compared to the preconditions surgery.   "
40286|NCT02758301|"     The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients     with heart failure by assessing the relationship between changes in LINQ™ derived data and     other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.   "
39968|NCT02762461|"     This project will investigate worsening of symptoms in endometriosis patients undergoing     artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian     and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with     a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30®     questionnaire is included in the questionnaire.   "
39969|NCT02762448|"     Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin     Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study   "
39970|NCT02762435|"     After written informed consent eligible hospitalized patients will be randomized to one of 3     arms (1:1:1:): control, sham, accupressure (3 points on the hand and wrist three times per     day). Quality of recovery and other measures of patient satisfaction will be recorded.   "
39971|NCT02762422|"     Blood donation has been proposed to be associated with reduced risk of cardiovascular     disease, but the effects of phlebotomy on vascular function in human subjects have not been     well characterized. A prospective randomized double-blind study was undertaken to determine     the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular     endothelial function in the brachial artery.   "
39972|NCT02762409|"     Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce     Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by     the patients of intensive care, implemented at the level of the whole intensive care unit,     reduce the incidence of the depressive symptoms one year after intensive care exit.   "
39973|NCT02762396|"     NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young     adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and     plaques and consequences of stroke are examined by standardized diagnostics.   "
39974|NCT02762383|"     This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in     participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV).     Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA)     after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a     low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety     and tolerability. Secondary objectives are to evaluate histological, virological, and     biochemical effects.   "
39975|NCT02762370|"     This study is a double-blind, randomized, parallel group comparison of the effects of FX006     and Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in the     protocol) on blood glucose in patients with osteoarthritis of the knee and Type 2 diabetes     mellitus.   "
39976|NCT02762357|"     The aim of this study is to show that the performance of Novosyn® Quick suture material is     comparable with other suture material used for episiotomy. In order to show that, various     safety and efficacy parameters have been selected. The outcome regarding these parameters     will be evaluated by a quantitative summary of the available clinical data from the     literature. Study population consists of women with a spontaneous vaginal delivery who     required perineal repair due to an episiotomy.   "
39977|NCT02762344|"     Observational cohort registry: prospective, multicenter independent evaluation of patients     who undergo coronary angiography and/or PCI via radial artery. The purpose of this registry     is to set the incidence of RAO according to ACT values, considered both as continuous and     ordinal variable and its determinants. Coronary angiography and PCI will be performed     according to usual practice.   "
39978|NCT02762331|"     Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac     surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following     CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third     post-operative day. Reduction of AF by various drugs is moderately effective, but involves     either rate control with beta blockers or rate conversion with amiodarone after the     myocardial damage processes initiating AF have already occurred. Decreasing the incidence of     post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could be     more fruitfully approached by targeting the upstream combined processes of inflammation and     coagulation activation induced by the surgical insult and associated ischemia-reperfusion     (I/R). We propose that cell damage induced by oxidative stress and I/R injury could be     prevented and/or inhibited by antioxidant supplementation. Specifically the investigators     hypothesize that high-dose intravenous (IV) vitamin C supplementation will ameliorate ROS and     therefore damp down upstream inflammatory processes, leading to a reduction of downstream     adverse events with demonstrable links to inflammation processes, such as AF.   "
39979|NCT02762318|"     Identify novel genetic variants causing skeletal dysplasia in Qatari populations and to     additionally develop an understanding of how those variants influence skeletal biology at a     molecular and cellular level.   "
39980|NCT02762305|"     The hypothesis of this study is that participation in the Retired and Senior Volunteer     Program (RSVP) Bone Builders program 1 hour, twice per week, for a minimum of 12 weeks will     result in significant positive changes to the health status of older adult participants     compared to controls including increased leg strength, improved balance, improved balance     confidence, increased walking speed, decreased fall risk, and increased life satisfaction.   "
39981|NCT02762292|"     Introduction In patients assisted by mechanical ventilation, the Work Of Breathing (WOB) is     shared between the patient and the ventilator. During weaning from mechanical ventilation,     the WOB performed by the patient must be adequate and efficient to sustain spontaneous     ventilation after extubation. The monitoring of WOB during weaning might allow a better     management of the weaning process. Esophageal pressure (PES) is the reference technique to     measure WOB but alternate tools have been proposed. The main hypothesis is that Indirect     Calorimetry (IC) is valid to track the changes in energy expenditure due to the changes in     WOB in mechanically ventilated children during weaning from mechanical ventilation. The     primary objective of this study is to assess the validity of IC method for the WOB assessment     when compared to PES measurement and Electrical Activity of the diaphragm (EAdi) during a     spontaneous breathing trial (SBT) in continuous positive airway pressure, which is a routine     extubation readiness test which generally induces an increase in WOB.      Methods This is a prospective single center study. All intubated and mechanically ventilated     children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will     be eligible.      Simultaneous recordings of Energy Expenditure, PES and EAdi will be performed during 3 steps:     before, during and after the SBT. Then outcome of patients will be collected.      The investigators plan to study a sample of 15 patients to be representative.      Relevance to the importance of child health in Canada The investigators expect that the     IC-based less invasive method will provide an accurate estimation of WOB assessment. Once     this tool is validated, the interest of IC to (i) early detect an increase in WOB during     mechanical ventilation in children, (ii) to assess the ability to extubate them and (iii) to     optimize nutritional support will be assessed in future studies.   "
39982|NCT02762279|"     Background During ventilatory assistance, optimization of settings is critical to allow a     personalized support and avoid over- or under-assistance. But little data are available in     clinical practice to guide the adjustment of the support. In adults, esophageal pressure     (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical     studies suggest that PES may be useful to guide the management of mechanical ventilation. In     children, the PES measurement could have similar potential benefits, but beforehand the     reliability of PES to estimate PPL needs to be assessed.      Objective The primary objective of this study is to validate the reliability of PES directly     monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate     PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.      Method This is a prospective single center study. Children <18 years old, hospitalized in the     pediatric intensive care unit, requiring invasive ventilation and with at least one chest     tube will be included.      Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured     by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously     recorded.      Expected results We expect that the PES-based methods will provide an accurate estimation of     PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in     children, and further interventional trials would be warranted to evaluate if its use could     allow a reduction of the ventilation support duration.   "
39983|NCT02762266|"     This randomized phase III trial studies how well transarterial chemoembolization (TACE) works     compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation     therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer     have been made (residual) or has come back (recurrent). TACE is a minimally invasive,     image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication     and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may     be able to send radiation directly to the tumor and cause less damage to normal liver tissue.     It is not yet known whether TACE is more effective than SBRT or SABR in treating patients     with persistent or recurrent liver cancer who have undergone initial TACE.   "
39984|NCT02762253|"     This study is being conducted to assess the safety and effectiveness of photochemically     induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and     Ecstasia.   "
39985|NCT02762240|"     Accreditation is used increasingly in health systems worldwide. However, there is a lack of     evidence of the effectiveness of accreditation. The overall aim of this study is to evaluate     the effectiveness of a mandatory accreditation in general practice.   "
39989|NCT02762188|"     Age-Related Macular Degeneration (ARMD) is the most common cause of blindness in the adult     population of the Western World. It affects the macula - the region of the retina most rich     in photoreceptors and responsible for central vision. The ethiology of ARMD remains poorly     understood. Population-based studies have demonstrated a complex ethiology, with     contributions from a combination of genetic and environmental factors.      Two major forms of ARMD are clinically distinguishable: the dry and wet form. The latter     represents the more aggressive clinical subgroup, and is characterized by the abnormal growth     of new blood vessels (neovascularization) under the macula, thus leading to the accumulation     of fluid under the retina, bleeding, progression to fibrosis, and finally loss of central     vision.      The pathogenesis of this neovascularization is not fully understood, although the VEGF     pathway is well known to be involved in angiogenesis and was implicated in the development of     the new vessels under the macula. The VEGFs are the most specific and potent stimulators of     the angiogenesis.      Molecules that bind and inactivate the VEGF have been developed for the treatment of ARMD and     they are applied in ARMD clinic through intra vitreal injections.The difference seen in     response to anti VEGF treatment for ARMD between the patients is suggestive for the presence     of factors influencing the effect of the drug. Some of these could be genetic variants within     genes involved in ARMD pathogenesis or VEGF pathway. Few associations with markers within     genes previously found to be related with the pathogenesis of ARMD have been found. It     remains unknown whether variants involved in the anti VEGF treatment response could influence     the therapeutic outcome.      The purpose of this trial is to evaluate the association between a panel of selected     polymorphic markers in the VEGF pathway and the response to therapy with anti VEGF antibody     for ARMD. The hypothesis is that the individual genotype influences the response to the anti     VEGF. This can lead to identification of genetic biomarkers allowing treatment     individualization and optimization of the visual outcomes.   "
39990|NCT02762175|"     Background      Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized     by intense snoring and repetitive complete or partial obstructions of the upper airway during     sleep together with daytime sleepiness. Several non-invasive therapeutical options exist,     however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA)     surgery is a procedure which changes the upper airway in a permanent way.      Objectives      The investigators aim to develop a prospective database registering 3D volumetric changes of     the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of     life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient     demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters,     orthognathic surgery, polysomnographic and QOL data are being collected during consecutive     visits within the framework of routine practice.      Design      A prospective, observational cohort study      Study center      General Hospital (AZ) Sint-Jan Brugge-Oostende      Population      The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr.     Neyt starting from January 2015.      Endpoints      The investigators aim to collect data that could provide information about the advantages and     disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS     patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and     quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the     OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index     (AHI).      Duration      In light of the continuous improvement of patient care, a database will be maintained from     January 2015 onwards to enable registration of large-scale OSAS patient data.      Conclusions      Development of a database registering 3D CBCT planning, polysomnographic data and quality of     life (QOL) of all consecutive patients eligible for MMA, will provide more information about     potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the     associated biological benefits of this procedure on the upper airway volume, the AHI and     general QOL. Moreover, registration of those results could function as a measurement of     quality of care, or could be used for sample size calculation for future large multicenter     prospective trials.   "
39991|NCT02762162|"     ONASSIST is a registry of coronary ill patients who have had a functional test measuring     anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.   "
39992|NCT02762149|"     Epidural analgesia is commonly used for labor pain relief due to its safety and     effectiveness. Despite a very high success rate, the epidural technique remains a somewhat     blind technique and failures continue to occur. Unfortunately, there are no imaging     techniques that can be used at the bedside to determine the proper positioning of the     epidural catheter. The trans-catheter electric stimulation test (TCEST) has been successfully     used for this purpose. This test is occasionally performed in situations where the immediate     confirmation of the proper epidural catheter location is deemed necessary. The test helps to     predict which epidurals might fail so that appropriate measures could be immediately     implemented.      There has been one duration of electrical stimulus (0.2 milliseconds) that has been used in     the majority of studies and in clinical practice. With this duration of stimulation, the vast     majority of cases show a unilateral motor response of the lower limbs during the TCEST.     Studies on the stimulation of peripheral nerves (nerves in the arms and legs) have shown that     an electrical stimulus with a longer duration is able to stimulate nerves which are farther     away. Since nerves in the epidural space are similar in composition to peripheral nerves, the     investigators expect to see a higher rate of bilateral response with the longer duration of     stimulus. The investigators also hope to show that this bilateral response is predictive of a     better functioning epidural.      The investigators hypothesize that the incidence of a bilateral response to the TCEST will be     higher with the 1.0 ms pulse width compared to 0.1 ms pulse width. Furthermore, the     investigators hypothesize that a bilateral motor response associated with the 1.0 ms pulse     width will be predictive of symmetry of sensory and motor block and of lower consumption of     local anesthetic.   "
39993|NCT02762136|"     Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with     high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although     the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for     alleviating PDS symptoms has been assessed in previous studies, more convinced evidence of     randomized placebo-controlled study is needed.   "
39994|NCT02762123|"     The study is being conducted to assess the effect of BMS-986142 on the single-dose PK     parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for     (cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.   "
39995|NCT02762110|"     Evaluate the feasibility of using a novel imaging test, [18F]ISO-1 PET/CT to image sigma-2     receptor binding in cancer. Correlate uptake with standard and experimental pathology assays     of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18     years, with a known or suspected breast cancer and at least one lesion 1.0 cm in size by at     least one type of standard imaging.   "
39996|NCT02762097|"     Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of     embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in     womb affects chances of pregnancy in women in whom no other causes of subfertility can be     found. Half of the women would have these polyps removed after their consent and the other     half who would not consent would not undergo any such intervention   "
39997|NCT02762084|"     Multicenter, double-blind, randomized, vehicle-controlled evaluates the efficacy and safety     of patidegib gel, 2% and 4% in comparison with vehicle in subjects at least 18 years of age     that meet the diagnostic criteria for basal cell nevus syndrome (BCNS). Subjects will be     randomized to receive patidegib gel 4%, patidegib gel 2%, or the vehicle gel for a 26 week     treatment period.   "
39998|NCT02762071|"     This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for     pain control after total shoulder replacements. Each method will be assessed in terms of post     operative pain scores, pain medication consumption, length of stay, complications (nerve     injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The     aims of this study will be achieved through a randomized controlled trial and     cost-effectiveness analysis.   "
39999|NCT02762058|"     The goal of this study is to investigate the effects of virtual reality based mirror therapy     (VMT) on individuals with acquired brain injury when compared to a control group receiving     traditional mirror therapy (TMT). This is a randomized controlled pilot study in which     patients with hemiplegia will be assigned to VMT or TMT and the impact on upper extremity     function will be observed.   "
40002|NCT02762019|"     Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side     effects among which oral mucositis (OM) is one of the most debilitating. Modifications of     CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor     general conditions and debilitation. Moreover, the use of narcotic analgesics and total     parenteral nutrition may be required, triggering not only a physical deficit but also an     economic burden. Despite the frequency and impact of OM among children with cancer, there is     no consensus on standard therapy for this condition. Previous studies demonstrated that high     power laser therapy can help the maintenance of nutritional status in patients with OM and     can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in     reducing symptoms and in preventing the onset of OM in adult cancer patients but only one     randomized controlled trial, with a limited number of children enrolled, supports its use in     children for treatment of OM induced by chemotherapy.      This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for     treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.      The study involves 8 italian hospitals.   "
40003|NCT02762006|"     The purpose of this study is to investigate the safety and feasibility of administering     investigational drugs (meaning not Food and Drug Administration (FDA)-approved for kidney     cancer) prior to surgical treatment for kidney cancer. The first drug is called MEDI4736, and     the second drug is called tremelimumab. Both of these drugs work by attaching to certain     proteins on immune cells with the goal of stimulating an immune response against cancer     cells. This is a phase 1 trial, with the primary goal of identifying if this treatment is     safe and possible side effects when given prior to surgery for kidney cancer.   "
40004|NCT02761993|"     The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an     adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal     disease.   "
40005|NCT02761980|"     This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose     Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with     fever. Results for the Fixed Dose Combination product will be compared to the individual     components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.   "
40006|NCT02761967|"     This study evaluates whether the use of moderate physical exercise character in water is     beneficial for pregnant women. Half of the participants will carry out moderate physical     exercise character in water, following the protocol developed specifically for this purpose     and called SWEP method, while the other group will not perform physical exercise during     pregnancy.      Concluded the postpartum period, women perform exercises aimed postpartum recovery. The     women's group has conducted exercises during pregnancy postpartum recovery made under the     guidance of LPF method.   "
40007|NCT02761954|"     With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and     the basilar artery (BA) after the caudal block changes.   "
40008|NCT02761941|"     The aim of this study is to investigate the clinical significance of high INR (International     Normalized Ratio) values (>9) in VKA (vitamin K antagonist) treated patients with atrial     fibrillation. The clinical characteristics of these patients will be studied as well as the     clinical presentation. Factors influencing on high INR values will be recorded and the aim is     to seek out patients who have elevated risk of bleeding complications.   "
40009|NCT02761928|"     Observational study of axial spine pain and hyperflexibility. Patients will receive physical     exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's     hypermobility score) and blood / urine / saliva collection. They will also be separated into     pain groups based on their response to injections. A correlation between exam findings and     procedure group will be measured.   "
40010|NCT02761915|"     The purpose of this first in human study is to determine the safety and feasibility of     1RG-CART therapy in patients with relapsed or refractory neuroblastoma. 1RG-CART therapy is a     novel immunotherapy under investigation in which patients have their T-cells (a type of white     blood cell) collected and modified in the laboratory, before they are given back to the     patient. The T-cells are modified to express a chimeric antigen receptor (CAR) which targets     disialoganglioside (GD2), a marker expressed on the surface of neuroblastoma cells.   "
40011|NCT02761902|"     The study is designed to investigate normal polysomnographic respiratory values of Chinese     healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters     of respiratory and sleep architecture，we hope to characterize normal polysomnography values     in Chinese children and adolescents and to establish respiratory reference values for     pediatric polysomnography which based on Chinese children's data.   "
40012|NCT02761889|"     The present study evaluates the clinical outcomes following definitive ultra-high dose per     fraction external beam radiation therapy delivered in patients with organ-confined     adenocarcinoma of the prostate.      Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc     radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance     procedures with emphasis on normal tissue sparing and delivery accuracy via the use of     devices that ensure stability and beam location reproducibility. A rectal balloon with air     filling will be used for prostate target immobilization and anatomical reproducibility, while     a urethral catheter loaded with beacon transponders will be used to ensure set-up     reproducibility and online target tracking. Previously untreated patients with prostate     cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.      Patients will be followed at one month post-treatment and every 3 months for up to 12 months     (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. Acute and late toxicity     evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and     will be assessed through validated Expanded Prostate Cancer Index Composite (EPIC),     International prostate symptom score (IPSS) and International index of erectile function     (IIEF) questionnaires. Serum Prostate Specific Antigen (PSA) values will be drawn on the same     schedule as clinical follow-up. Patients will be continuously monitored for a minimum of 5     years.   "
40013|NCT02761876|"     The purpose of this study is to test if a participatory, agroecological peer farmer-led     education intervention can be effective at improving legume production, food security, and     infant and young child feeding practices in Singida District, Tanzania.   "
40014|NCT02761863|"     This is a prospective study evaluating the effect of expression of CD74 and VEGF on outcome     of treatment in patients with malignant pleural mesothelioma receiving Pemetrexed/Platinum     protocol. The paraffin blocks of the patients will be tested for CD74 and VEGF before     starting treatment using IHC and the results will be correlated with the outcome of treatment     during evaluation.   "
40015|NCT02761850|"     The purpose of prospective cohort study is to describe the developmental profile of     refraction change in a large cohort of Chinese CC patients. The decisive factors to the range     of myopic shift in unilateral CC appeared to be different from that in bilateral CC,     indicating dramatic differences in the etiopathogenesis and refractive prognosis between     bilateral and unilateral CC.   "
40016|NCT02761837|"     The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness,     cost-effectiveness, and implementation of the Breathe Well intervention, which combines     evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care to     improve asthma outcomes.   "
40017|NCT02761824|"     Implementation and Evaluation of an Activity Based Program to Improve Quality of Life     Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction (with     evidenced gathered at three consecutive periods and geographical locations through Quality of     Life surveys).   "
40018|NCT02761811|"     To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath     I™ in patients with pharmacotherapy and uncontrolled hypertension for at least 6 months, then     after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days,     office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.   "
40019|NCT02761798|"     This observational study aims to validate the use of a tablet based audiometer to provide an     accurate, efficient, and cost-effective means for diagnosis of hearing conditions in     controlled and uncontrolled environments in adult and elderly populations.   "
40020|NCT02761785|"     The research aims to investigate the effects of gluten-free oats to the gastrointestinal     health in celiac disease patients and healthy subjects. The effects of gluten-free oats on     the several intestinal parameters, on the composition of the gut microbiota as well as on the     metabolic profile of celiac patients and healthy controls will be studied. The study is     divided into two parts.      Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over     study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants     for the part 1. The study will be conducted with a cross-over setting, where the subjects     will go through exposure meals and SmartPill ingestion three times (two different oat     products and placebo) in a randomized order. The study meals are identical in appearance and     fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which     will send data on intestinal pH, pressure and temperature to the external portable device.     Before and during the passage of capsule the subjects will fill a symptom and food diary. The     capsule will exit the body in 1 to 3 days and the data collected by the external device will     be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and     a blood sample. In addition, 36 hours urine samples will be collected.      In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls     will be recruited and they will be divided into four groups: oat-avoiding celiacs (1),     oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4).     Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a     fecal sample will be collected from the subjects. The gut microbiota will be analyzed from     the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood     samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing     techniques.   "
40037|NCT02761551|"     Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,     only about half of children are vaccinated annually leading to substantial influenza disease     in children and spread of disease to adults. A major barrier is that families are not     reminded about the need for their children to receive influenza vaccination. The     investigators will evaluate the impact of patient reminder/recall (R/R) performed by state     immunization information systems to improve influenza vaccination rates by using three     clinical trials in two states. The investigators will assess effectiveness and     cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The     investigators will disseminate the state immunization information system based     reminder/recall system to all states for use for both seasonal and pandemic influenza     vaccinations with the goal of lowering influenza morbidity.   "
40021|NCT02761772|"     Miscarriage is a common event associated with severe psychological and social morbidity,     further tormenting in women suffering recurrent pregnancy loss (RPL) by at least three     consecutive losses.      Ultrasonography and biomarkers have yet to precisely predict viability in pregnancies with     symptoms of threatening miscarriage.      A novel biomarker Preimplantation Factor (PIF) derived by the developing embryo might be the     key factor for this prediction ameliorating the implantation process by promoting a favorable     local immune system in the uterus.      The investigators aim to establish a prospective early pregnancy cohort (PEP-cohort) that     includes women throughout the first trimester by both assisted reproductive technology (ART)     and spontaneous conceptions. By a combination of consecutive ultrasonographys and blood     samples of known predictors of implantation PIF as a predictor of viability will be     evaluated.      These data are finally compared to the same data in a retrospective cohort of RPL patients     emphasizing the role of PIF.      All collected data will be stored in a Research Biobank for the current studies outlined as     well as potential future studies of reproductive medicine in the first trimester.   "
40022|NCT02761746|"     This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, and Washington,     DC), two-group randomized controlled trial testing a two-session intervention designed to     increase motivation for adherence to antiretroviral treatment (ART) among youth living with     HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the     intervention, Motivational Enhancement System for Adherence (MESA), or the control condition,     System for Health (SH: healthy eating and physical activity information). Both groups receive     the standard of care regarding the initiation of ART. ART adherence (visual analog scale and     hair sample assay) and health outcomes (viral load results, and CD4 counts) are assessed.     Additionally, potential mediators (HIV knowledge, motivation for adherence, and self-efficacy     for adherence) and predictors of intervention response (substance abuse, mental health     symptoms, executive functioning, and stressful life events) are assessed.   "
40023|NCT02761733|"     The primary goal of the proposed study is to investigate the implementation and effectiveness     of the mPOWR (Moving Patient-centered Outcomes through Wellness and Recovery) in diverse     urban and rural community mental health settings. The study compares patient participation     and outcomes using the mPOWR system to a usual care control condition. Four community mental     health agencies participate in the research: two in San Francisco (urban) and two in N.M.     (rural). One site in each setting serves as the mPOWR implementation site and the other     serves as the control site. Service sites were randomly assigned to intervention or usual     care conditions. A quasi experimental design was used; only eligible participants were     enrolled in the study (e.g., exclusion criteria of moderate to severe cognitive impairment,     patient services structured for provision of mPOWR implementation, etc.). The study design     will employ repeated quantitative measures to assess change in outcomes within and across     conditions over time. Qualitative methods in the form of focus group interviews will also be     used to round out the information obtained about patient and provider expectations and     experiences. Primary outcomes of interest include: Short Form Health Survey-12 (SF-12;     physical and mental health aspects of health and well-being); Outcome Rating Scale (ORS;     general well-being, personal well-being, close relationships, and work/school/friend     relationships); Shared Decision Making Questionnaire (congruence of patient's and provider's     participation in therapeutic decision making and patient's understanding of treatment and     treatment options); Working Alliance Inventory (perception of therapeutic alliance); and     Satisfaction Questionnaire (communication patterns between physicians and their patients).   "
40024|NCT02761720|"     The Mobile Mood Tracking App study is a small randomized trial of acceptability and usability     of a mobile phone mood tracking application (mobile app) among women with depressed mood in     pregnancy. The study will be assessing the perceived value and usability of this tool in     pregnancy over eight weeks to test whether women using this app are more likely to receive     assessments and treatments of depressed mood than women not using it.   "
40025|NCT02761707|"     This study seeks to establish the sensitivity and specificity of what appears to be a unique     brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic     nasotrigeminal reflex response - in differentiating early stage PD from normal controls and     from patients with various other neurodegenerative diseases. This study will additionally     compare the biomarker to olfactory testing.   "
40026|NCT02761694|"     An open-label, Phase 1, dose escalation study of ARQ 751 in subjects with advanced solid     tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other     known actionable PTEN mutations   "
40027|NCT02761681|"     This study will develop and then test a web-based guided self-help version of Acceptance and     Commitment Therapy (ACT) to be utilized at college counseling centers (CCCs). ACT is an     evidence-based transdiagnostic therapy found to effectively treat a range of psychological     problems. An ACT program would provide a means of implementing effective treatment for the     range of problems in the CCC setting, while the guided self-help format would reduce     counselors' workload, improving cost-effectiveness and reducing waiting lists. This would     both treat students and train counselors in how to implement the ACT intervention.   "
40028|NCT02761668|"     Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and often     motivation for patients to seek orthodontic therapy. An interdisciplinary approach is     required to control the periodontal infection, reconstruct the defects and realign the     migrated teeth. The optimal timing of active orthodontics after regenerative therapy is a     topic of ongoing debate.      There are no data available from RCTs that have compared the effect of the timing of     orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal     surgery in these patients.      It is the aim of the present randomized clinical multicenter trial to compare 2 different     treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced     periodontitis patients with intrabony defects and pathologic tooth migration in order to     establish whether one treatment modality is superior to the other with regard to clinical     outcomes. A total of 46 patients will be enrolled and randomized into 2 treatment groups that     differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late: 6     months following regenerative periodontal surgery).      Primary outcome measure will be the change in clinical attachment level (CAL gain) at 12     months after regenerative therapy. Secondary outcomes will include changes in probing depth     BOP, gingival recession, radiographic bone height and patient-centered outcomes.   "
40029|NCT02761655|"     Background and Purpose: Previous studies indicate that baseline cognitive abilities,     especially prospective memory (PM) significantly influence medication adherence. However,     there are only three qualified intervention studies on adherences in persons with cognitive     impairment (PWCIs). In addition, family caregivers (FCGs) are often asked to assist PWCIs in     managing their medication but FCGs' medication administration hassles are not intensively     investigated. Therefore, the purpose of this project is to test the effectiveness and     efficacy of a theoretical-based multifaceted memory intervention on medication administration     and quality of life in PWCIs living at home and medication administration hassle of their     FCGs.      Study Design: This is a three-year project (2015, 8, 1-2018, 7, 31). The aims of the     first-year study are: 1.to develop a multifaceted memory intervention based on the paradigm     of prospective memory (PM); 2. to pilot test the feasibility of the multifaceted memory     intervention through a small randomized control trial. The aims of the second- to third year     study are: 3. to examine the effectiveness and efficacy of the intervention (a randomized     control trial). The intervention group will receive a cognitive impairment education,     medication adherence and memory strategies training, while the control group will receive     only the cognitive impairment education program. The duration of the intervention is one     month. There will be 4 data collections (baseline, post-intervention 2 4, 6 months). Sample     size estimation for the pilot study is 5 dyads for each group. Sample size for the randomized     clinical trial is 84 dyads (42 dyads per group). After the attrition rate (10%) is counted,     in total, there will be 200 cases (100 dyads). Implications of this project: This three-year     program can help to identify those who may benefit from memory training and assist those who     may be incompetent living in community. Also this program will extend the current knowledge     of the role of PM playing in medication adherence behavior and its relationships with self     awareness as well as everyday decision making among PWCIs. In addition, health related     professionals can improve PWCI's quality of care and reduce FCG hassle by applying a     theoretical guided practice for memory training.   "
40030|NCT02761642|"     This study will evaluate the efficacy and safety of subcutaneous (SC) r-HuEPO in anemic     participants with breast cancer undergoing chemotherapy.   "
40031|NCT02761629|"     This randomized, multi-center, Phase IV, comparative study will assess the efficacy and     safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or     72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic     hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).   "
40032|NCT02761616|"     This is a retrospective, and observational cohort study to determine the proportion of breast     cancer first relapses, that are biopsied. The duration of the study will be approximately 24     months.   "
40033|NCT02761603|"     Over 30% of American adults have hypertension (HTN) (high blood pressure), and the rate     increases considerably with age; 64% of men and 78% of women over 65 have HTN. High blood     pressure associated with HTN can force of the blood against artery walls with enough pressure     that it can eventually cause health problems, such as heart disease and stroke. HTN is one of     the most significant causes of early death worldwide and one of the most preventable causes     of death. Many studies reveal that lowering blood pressure (BP) reduces the incidence of     diseases of the heart and blood vessels. Non-drug related treatments are known to reduce BP     which can have a great effect on public health. Research suggests that Tai Chi (TC) is     effective in lowering BP in patients with HTN, but because of the low quality of existing     studies there is no definite proof. Also, it is not known how TC reduces BP. One possibility     is that TC practice, which is shown to reduce psychological distress such as anxiety and     depression and reduce the body's responses to stress, can improve the balance of the     autonomic nervous system (the part of your nervous system that controls beating of the heart     and the widening or narrowing of blood vessels). This may lead to lower BP. The investigators     plan to investigate the pathways among autonomic, blood vessel, immune and psychological     factors in relation to BP changes in response to 12-weeks of TC compared with Healthy Aging     Practice-centered Education (HAP-E). 250 older adults (60+ years old) with mild HTN will be     enrolled, and the investigators will take several measurements of heart and nervous system     functioning. The investigators hypothesize that performing TC for 12 weeks will result in     autonomic re-regulation which will improve BP and blood vessel health (Aim 1) and     sympathetic nervous system (part of the nervous system that serves to speed up heart rate,     contract blood vessels, and raise blood pressure) regulation of the immune system (Aim 2).     Lastly, the investigators hypothesize that psychological factors will be related to TC     effects on autonomic regulation (Aim 3). Findings from the investigators study will hopefully     shed light on the pathways by which TC reduces BP. Also, the particular effects of TC     (meditative movement) in an older, hard-to-treat hypertensive population will be better     understood.   "
40294|NCT02758197|"     This randomized controlled trial will evaluate the effectiveness of an interdisciplinary     treatment approach combining medical management with an online Mindfulness-Based Stress     Reduction (MBSR) program in reducing disability and improving quality of life among cancer     survivors living with moderate to severe chronic neuropathic pain.   "
40034|NCT02761590|"     Introduction: The increase in intermuscular adipose tissue (IMAT) can contribute to muscle     weakness and consequently on progression of knee OA. The prescription of exercise protocols     has been used as a treatment strategy to minimize some of the bouts. Circuit training (CT)     involves the combination of strength training and aerobic in the same session and has shown     benefits in body composition and physical function. But the literature is unclear with     respect to the influences of CT in the concentration of IMAT in the population with knee OA.     Objective: To investigate the influence of a 14-week CT protocol in body composition and     thigh IMAT concentration as well as cartilage degradation indicators and systemic     inflammation and its impact on quality of life in patients with knee OA.   "
40035|NCT02761577|"     The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with     previously normal renal function undergoing angiography and comparison between the three     different treatment protocols on renal function.      Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate     (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion.      Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated     lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as     an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 48-72     hours after the procedure   "
40036|NCT02761564|"     Current international guidelines suggest a restrictive transfusion strategy, setting that Hb     level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for     all the patients has been challenged by authors, suggesting a more liberal strategy for     certain cases. At the moment, there is no other parameter considered accurate enough to be     taken into consideration for transfusion strategy management.      This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion     in order to stratify its indication after cardiac surgery.      Monocentric, randomised, single blind study (patient not aware of the group assignments)     Patient inclusion will be made in ICU if the physician decides to perform blood transfusion     according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).      Every patient will go through randomization to be placed in one of the two groups of the     study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2     (group ScvO2), or the control group.      Our main objective is to evaluate the impact of a new transfusion strategy founded on     guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells     transfusion for anemia early after cardiac surgery.   "
40080|NCT02760979|"     This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption     after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30     Denosumab) within a year after surgery.   "
40081|NCT02760966|"     Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the     complication rate in the newborn.   "
40038|NCT02761538|"     The investigators developed the Aviitam® online platform. The purpose of the project is to     test the medico-economic impact related to the utilization of the Aviitam online platform in     primary care.      Primary objective: To assess the cost-effectiveness at 24 months follow-up of the utilization     of the Aviitam® online software in primary care for people with obesity and at least one     comorbidity compared to a usual follow-up in primary care.      Secondary objectives: Weight loss; quality of life ; blood pressure change; changes in lipid     profile, blood glucose and HbA1c; physician satisfaction; patients satisfaction, profiling of     patients and data mining analysis on the collected data.      Method : Overweight & obese patients with associated comorbidities will receive a 24 months     follow-up to assess the impact of the use of the online platform Aviitam®.      Practitioners will be randomized by lot between an Aviitam® group and a control group (usual     care).      A medico-economic analysis will be conducted with a cost-effectiveness analysis and a budget     impact analysis.      With no hypothesis on the primary endpoint, the calculation of the required number of     subjects was based on the quality of life. 150 patients will be included per group Patients     of the 2 groups will be assessed at baseline and after 24 months. The first day of each     month, each patient included in the study will receive a questionnaire to fill online to     evaluate their health care consumption in the previous month and the EQ5D questionnaire , a     standardized questionnaire validated in French to assess the effects on health and to be used     to calculate cost - utility.      Expected results and perspectives Proving the effectiveness of the Aviitam® online program     focused on non-drug therapies and therapeutic lifestyle changes for overweight and obesity     management with reduced health costs, improvement in quality of life, reduction in weight and     improvement of comorbidities.      In terms of public health, the use of the platform Aviitam® can be expect to improve     management of excess body weight and reduced health costs. Furthermore, Aviitam® could be a     valuable tool to support healthcare professionals in outpatient therapeutic education     approaches.   "
40039|NCT02761525|"     The purpose of this study is to determine whether oral topic silver nanoparticles are     effective to reduce potential pathogen microbial loads in mechanical ventilation patients.   "
40040|NCT02761512|"     To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of     therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration     of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.   "
40041|NCT02761499|"     This is a prospective, single arm, multi-center, post-approval study designed to evaluate the     short and long term clinical performance and safety in subjects receiving primary total hip     arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.   "
40058|NCT02761278|"     The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium of     infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and     HOXA11 are well-established markers of implantation. It is uncertain as to whether an     endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and     HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo     implantation.   "
40295|NCT02758184|"     The Purpose of this study is to identify added value of Rotational thrombo-elastometry     (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major     reconstructive spine surgery.   "
40043|NCT02761473|"     Pediatric mastocytosis is an orphan disease, which encompasses several clinically distinct     entities including solitary mastocytoma, urticaria pigmentosa, diffuse cutaneous mastocytosis     and the newly recognized mast cell activation syndrome. The most common form of pediatric     mastocytosis is cutaneous maculopapular mastocytosis (CMPM), also known as urticaria     pigmentosa (UP). There are significant knowledge gaps regarding the genetic basis of     pediatric mastocytosis and the functional activity of mast cells in this condition. The     Pediatric Dermatology and Pediatric Oncology services at the University of Minnesota Masonic     Children's Hospital are seeing significant growth in clinical volumes of pediatric     mastocytosis, including rare, familial cases. The aims of this study are to prospectively     explore germline risk for UP and to perform a mutational analysis to identify somatic     mutations, beyond those currently identified, in pediatric patients with UP.   "
40044|NCT02761460|"     The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing     chemotherapy-induced neutropenia   "
40045|NCT02761447|"     This study evaluates the effectiveness of imagery motor on phantom pain and amputation     process   "
40046|NCT02761434|"     Data from experimental animals and human epidemiological studies have suggested that     hypohydration and/or low water intake is linked to poor glucose regulation and diabetes. The     aim of this study is to investigate the effects of cellular dehydration on glucose in healthy     non-diabetic individuals. METHODS: 60 males and females (30-55 y) will will undergo two     experimental trials (ISO and HYP), consisting of a 2-h intravenous infusion of isotonic or     hypertonic saline on two separate occasions, followed by a 4-h oral glucose tolerance test.     Blood samples were taken from an antecubital vein in 30-min intervals starting at baseline     for assessment of fluid and glucose regulating factors. Thirst will be assessed via visual     analog following each blood sample. Energy substrate oxidation will be calculated via     indirect calorimetry every 60 min.   "
40047|NCT02761421|"     To investigate the motor development, motor function and electrodiagnostics presentation in     IOPD under ERT.   "
40048|NCT02761408|"     The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation     associating dermatitis or mucositis in head and neck cancer patients who accept     chemoradiation therapy   "
40049|NCT02761395|"     1. Evaluate the therapeutic effects, health benefits, and immunological effect of          Al-hijamah in children with beta thalassemia major.        2. Evaluate the extent of clinical improvement, reductions in serum iron and ferritin,          antioxidant status, in those patients.   "
40050|NCT02761382|"     This study evaluates the effects of psychological treatment on pain, quality of life and work     ability among women with endometriosis related chronic pelvic pain in a three-armed,     randomised study. One group will receive mindfulness-based psychological treatment, the     second group will receive a non-specific general psychological treatment (a psychological     placebo) and the third group will be a waiting list control (treatment as usual).   "
40051|NCT02761369|"     The neurobiological underpinnings of obesity point to brain asymmetry in cortical and deeper     brain regions. Furthermore, chemical, structural and functional imbalance in cortical and     sub-cortical brain regions alters reward processing, attentional control and self-regulation     in food-addicted obese individuals. In this study the investigators use TMS with a special     multichannel H-coil developed by their lab to safely stimulate cortical and deeper brain     regions in obese humans. The investigators aim to produce interhemispheric neuroplasticity     (INP) using a paired associative stimulation (PAS) protocol over the DLPFC, to restore     neurobiological functioning, alleviate food addiction symptoms, and promote weight loss.   "
40082|NCT02760953|"     The purpose of this study is to evaluate the safety and efficacy of applying cryoablation as     an adjuvant therapy with TUR to treat bladder tumor.   "
40052|NCT02761356|"     Patients cohort is composed of 50 consecutive patients both male and female with hepatic     malignancies, refered to our nuclear medicine department in the process of radioembolization     between January 2010- August 2015. 26 of the patients were examined with Tc99-MAA and     SPECT-CT and 24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT. Our study     protocol was as follows:        1. Collection of anamnestic data        2. Calculation of liver tumor volume with quantification software        3. Evaluation of the liver tumor involvement        4. Evaluation of liver to lung shunt        5. Calculation dose of SIRTEX        6. Y90 imaging        7. Follow Up   "
40053|NCT02761343|"     This study will evaluate the feasibility of visualization and characterization of arrhythmia     ablation lesions by MRI immediately following standard ablation techniques. The appearance of     the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia     recurrence.   "
40054|NCT02761330|"     This study is geared toward characterizing the recovery of brain activity and cognitive     function following treatments of electroconvulsive therapy and ketamine general anesthesia.   "
40055|NCT02761317|"     The study compares the efficacy of bowel cleansing between the standard preparation (2 L     polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg     bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with     previous colorectal resection.   "
40056|NCT02761304|"     The reduction in the rate of caesarean section is a major public health issue, it has reached     21% in 2010 Fance. Indeed complications to expect during pregnancy and childbirth increase     doubles the risk of fetal morbidity, néonatal and maternal history of when césareinne.     recommendations for clinical practice (RPC) to scarred uterus are being drafted under the     auspices of the National College of obstetrics and gynecology (CNGOF) well highlighting the     health problem public this represents. During 2011, 15% of the 2,700 patients who have     recently given birth to the north of Marseille Hospital were carriers of a scarred uterus     (internal data).The objective of the obstetrician is to ensure the welfare mother and fetus     at the end of pregnancy and childbirth. To do this, the realization of a work being cesarean     allows in some cases to reduce neonatal morbidity related to workflow especially in case of     abnormal fetal pericardial pace that suggest fetal hypoxia. However, a significant number of     caesarean section is performed by the side of caution during the second part of the work to a     suspicion of non-engagement of the fetal presentation. These caesareans are indicated,     rightly, before a clinical doubt about the height of the engagement of the fetal presentation     in order to avoid making a difficult instrumental delivery, potentially harmful to the mother     (perineal tear 3rd and 4th degree) and fetus (head injury, intracranial hemorrhage,     cephalohematoma). A prospective study published in the Lancet estimated 37% error percentage     attributable to the clinical examination in case of doubt on the commitment of presenatation     fœtale. The CNGOF held through PRC publication what to do in case of obstetric clinical doubt     about the commitment of the fetal presentation and not recommended no show against an     instrumental extraction in this situation (RPC 2008).      Ultrasound has revolutionized pregnancy monitoring. Its routine use has in other prenatal     diagnosis of fetal pathologies, it is the other reference screening tool of the most common     obstetric pathology, preterm labor. Its use became widespread in the delivery room, the     presence of an ultrasound machine is recommended by the decrees of perinatal care in     maternity hospitals performing more than 1,500 deliveries per year. It is natural for     conducting ultrasound during labor has emerged, first to help identify the variety of the     presentation of the fetal head and then more recently in aid to instrumental delivery.     Several studies have shown that ultrasound had a sensitivity of commitment over 90% for     predicting the success of instrumental extraction and a vaginal delivery.      To our knowledge, to date, there is no study that investigated the benefit of ultrasound     commitment to reduce the rate of cesarean section during labor. To answer this question, we     want to show that making a commitment in case of diagnostic ultrasound of doubt about the     level of engagement of the fetal head (4% of births) reduces by 30% the rate of caesarean     section fully dilated.   "
40057|NCT02761291|"     Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus(EBV) related malignancy and is an     endemic disease in Southeast Asian countries. EBV had been identified as a therapeutic target     in some EBV related cancer such as lymphoma and NPC. In cancer cell, EBV was in latent phase     and expressed 8-11 genes for maintaining EBV proliferation. After switching to lytic phase,     almost all the EBV encoding genes were expressed including thymidine kinase (TK) and some     highly immunogenetic genes. These latent-lytic phase swifter included DNA methyltransferase     inhibitors, various histone deacetylase (HDAC) inhibitors, radiotherapy and chemotherapy.     Recently, combined chemotherapy and viral lytic therapy, cytolytic viral activation therapy     (CVAT) had been shown some promising result in pilot study of NPC. In our patient derived     xenograft (PDX) animal model drug sensitivity screening, gemcitabine (GEM) was shown to be     the most effective drug. Furthermore, CVAT with GEM + Valproic acid (VPA) + ganciclovir (GCV)     maintaining chemotherapy may benefit but reduce chemotherapy related side effect and     prolonging treatment response duration. The following phase I clinical trial will be proposed     to test the optimal combination of these drugs.        1. Number of patients: total 18 patients are needed        2. Inclusion criteria:(1) used as 2nd line regimen in recurrence/metastasis NPC patients          with tissue proved of World Health Organization (WHO) type II or type III.(2)          Performance status: eastern cooperative oncology group performance status (ECOG PS) ≤2.        3. Chemotherapy regimen: Gemcitabine (GEM, TTY) + Valproic acid (VPA, generic medicine) for          viral activation + Valganciclovir (VGC, Roche) for antiviral medication        4. This treatment cycle of 28 days was repeated maximum 6 times. (Q4wks/cycle, max: 6          cycles)        5. Dosage:      (1) GEM: 600, 800, 1000, 1250 mg/m^2, D1 & D8, intravenously. (2) VPA 12.5 mg/kg/day D1~14,     per os. (3) VGC (2-3) x 450 mg/day D9~15, per os. 6. Objectives:        1. primary: to find the best combination of these 3 drugs in recurrent/metastatic NPC          patients.        2. second: to evaluate the response and disease control rate in this pilot study.      Key words: NPC, cytolytic viral activation therapy, gemcitabine, valproic acid, ganciclovir.   "
40059|NCT02761265|"     Surgical intervention may provide pain relief and improvement in function but one area of     significant clinical interest is the restoration/improvement in gait and functional balance.     Based on the investigators knowledge, there is limited literature on biomechanics and     neuromuscular control of the lower extremities and spine as assessed by objective gait     analysis and balance strategies in adult degenerative scoliosis patients, pre and post     surgical intervention. The purpose of this study is to determine the impact of spinal     deformity on the biomechanics and neuromuscular control of the lower and upper extremities,     and also investigate the impact of surgery on these functions as evaluated by gait and     balance analyses using dynamic EMG, video motion capture and force plate analysis and also to     compare these patients with healthy controls to better evaluate the extent of limitations     before and after surgery.   "
40060|NCT02761252|"     The purpose of this study is to compare concomitant administration of Montelukast and     Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma   "
40061|NCT02761239|"     The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN)     and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human     cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the     laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during     thyroidectomy with intraoperative neuromonitoring (IONM).   "
40062|NCT02761226|"     Implants have become the preferred method of single tooth replacement these days, patients     receiving implant treatments not only expect restoration of masticatory function, they also     expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. To     maintain long-term implant stability, it is important to minimize bone loss around the     implant, as well as the soft tissue atrophy that accompanies it.   "
40063|NCT02761213|"     The aims of the present study is to compare oral sulfate solution (OSS) with low-dose     polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.   "
40064|NCT02761200|"     This exploratory study is designed to ensure the safety of HIV-infected volunteers who     complete research protocols that include an analytic treatment interruption (ATI). This is a     prospective cohort study of volunteers who were diagnosed with HIV during early acute HIV     infection, treated with antiretroviral therapy (ART) and subsequently enrolled in a clinical     study that included ATI. After completion of study participation that involves ATI,     participants will be recruited into this study for continued clinical and laboratory     monitoring.   "
40065|NCT02761187|"     The purpose of this study is to describe contemporary, real-world disease and participant     presentation, therapies, and clinical outcomes in both participants with newly diagnosed and     not yet relapsed [ND] multiple myeloma (MM), and participants with relapsed/refractory [R/R]     MM.   "
40066|NCT02761174|"     The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced     inflammation in terms of redness, swelling and pain in patients with facial vascular lesions     (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated     one month after final IPL-treatment.      The hypothesis is that brimonidine, which has been proved effective in reduction of     symptomatic erythema in patients with rosacea, also may have the ability to reduce     IPL-induced erythema. Since the potential reduction in erythema is caused by     vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.   "
40068|NCT02761148|"     White matter hyperintensity (WMH) has been found to be related with cognitive and emotional     dysfunction. A presumed mechanism is that WMH disrupts the structural connectivity within a     large-scale brain network, thereby impairing the brain's ability to integrate the neural     processes efficiently. It is not yet clear, what the pattern of brain network disruption     relates to WMH and how the brain network disruption induced by WMH has an effect on cognition     and emotion performance. Using multi-model magnetic resonance imaging (MRI) techniques, we     aimed to explore the mechanisms of cognitive decline and depression related with brain     network dysfunction in patients with WMH, and to provide objective imaging marker for early     diagnosis and prevention of WMH associated cognitive decline and depression.   "
40069|NCT02761135|"     Prostate cancer is the most common cancer among men in Sweden. During investigation of     suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to     diagnosis.      The most common technique today is side-fire where the needle enter the prostate in angle     from the probe. In end-fire technique the needle enters the prostate at tip of probe without     angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach     the ventral and apical aspects of prostate.      Today´s standard is at least five cores from each side of the prostate at first biopsy. If     first sample is negative there will usually be another urological exam and a first re-biopsy.      The study aim to compare these two methods in cancer detection. The investigators' hypothesis     is that when using end-fire technique at first re-biopsy, investigators find more cancers     compared to side-fire.      Patients are prospectively randomized into two groups, both assessing 12 core biopsies     according to study protocol.      Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level,     prostate size, digital rectal exam, hypoechogenic zones and length of cancers.   "
40070|NCT02761122|"     Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of     cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and     associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes     toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at     Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive     lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant     peptide of Human Papilloma Virus (HPV) 16.      In line with this recent work which shows for the first time a link between HPV-16 and an     autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis that     HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non     erosive lichen planus or lichen sclerosus.   "
40102|NCT02760693|"     monitoring system and data base for long term follow up of various treatment strategies in a     naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design,     prospective & retrospective   "
40071|NCT02761109|"     Incidence and risk factors for renal, cardiovascular and pulmonary complications after liver     transplantation are not well defined. Blood products requirement is an important aspect of     orthotropic liver transplantation (OLTx) management and has a great impact on patient's     outcome. Transfusions of blood products increase perioperative complications and reduce graft     and patients survival.      The primary endpoint of the study is to evaluate the incidence of renal complication during     ICU stay after liver transplantation using RIFLE criteria; secondary endpoint is to evaluate     the incidence of cardiovascular and pulmonary complications. In addition patients' survival     and the relationship between blood components use with the development of post-operative     complications are evaluated.   "
40072|NCT02761096|"     The aim of this study is to evaluate the effect of acupuncture on inflammation and immune     function after craniotomy. This study will be a single-center, parallel group clinical trial     that will be conducted at Kyung Hee University Hospital at Gangdong, Seoul, Korea.   "
40073|NCT02761083|"     The aim of this study is to show that the performance of Novosyn® Quick suture material is     comparable with standard suture material used in Ophthalmic surgery. In order to show that,     various safety and efficacy parameters have been selected. The outcome regarding these     parameters will be compared in 2 treatment groups. Active control group will receive Vicryl®     Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to     design this study as a randomized trial, because limited clinical evidence is available in     the literature for the active control group (Vicryl® Rapide) which can be used for     comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both     treatment groups.      Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion,     entropion, ptosis, eyelid tumor resection, blepharoplasty)   "
40074|NCT02761070|"     The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide     (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or     progression, comparing to bevacizumab alone.   "
40076|NCT02761031|"     This study will record patient electrocardiograms - as well as various other body signals     (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored     routinely both during and immediately subsequent to surgical operations performed under     general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV),     in concert with the other abovementioned parameters, the investigators seek to forward the     development of novel mathematical models and tools for on-line detection of cardiovascular     and autonomic dysfunction in the perioperative setting.   "
40077|NCT02761018|"     The investigators will recruit DoD beneficiaries, aged 18 years or older and diagnosed as     being Type II diabetic. Patients will be randomized into one of two groups. Group 1 will use     a fitness tracker but will not be able to see other participants data and group 2 will use a     fitness tracker and will be able to see other members daily and weekly results. Outcome     measures will be assessed at baseline, 3 months and 6 months to include hemoglobin A1c,     weight, body mass index, blood pressure, and number of hours and days fitness tracker is     used. The goal is to see if the group randomized into an online community will have improved     activity and outcome measurements compared with those who use the pedometer alone.   "
40078|NCT02761005|"     Patients infected with H. pylori are treated with the individualized regimen which is based     on the mutation of 23S rRNA of H. pylori.   "
40079|NCT02760992|"     The purpose of this study is to identify a suitable dosing regimen of IV baclofen to serve as     a temporary substitute for an oral regimen.   "
40083|NCT02760940|"     Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory     bowel disease, and it accounts for significant loss in the quality of life of these patients.     The aim of the current study is to assess the effect of orally administered iron treatment,     as well as its response predictors in patients with inflammatory bowel disease who are in     remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD)     and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the     Inflammatory Bowel Disease Center at the University Hospital of the Federal University of     Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood     samples will be collected (10 ml) and the following tests will be performed in all the anemia     patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood     count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular     hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin     saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP),     interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and     depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and     Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia,     therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered     anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild     and moderate anemia in remission will be initially treated with oral iron (oral liposomal     iron) and the occurrence of possible symptoms related to oral iron intolerance will be     assessed, as well as the patients' disease activity level and quality of life. The patients     in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment     week. The results of the current study are expected to help assessing the oral iron efficacy     and response predictors, as well as the side effects of the treatment and its impact on the     quality of life of patients.   "
40084|NCT02760927|"     Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with     Oral Endotracheal Tubes with Subglottic Suction   "
40085|NCT02760914|"     The aims of the present project are to study possible differences in inflammatory gene     expression and protein secretion in various compartments of adipose tissue being exposed     during open cardiac surgery in patients with coronary heart disease undergoing coronary     artery bypass surgery.   "
40103|NCT02760680|"     A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic     device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart     failure (CHF) and sleep-disordered breathing (SDB).   "
40086|NCT02760901|"     Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief     dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose     cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC)     ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the     protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.      Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin     nephrotoxicity in humans compared to mannitol and to each other.      Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin     were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving     acetazolamide and 17 patients receiving NAC. Patients` kidney function was monitored using     serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed     using RIFLE criteria. Patients` liver function tests and hematological parameters were also     monitored.   "
40087|NCT02760888|"     The purpose of this study is there difference between the effect of Tramadol orally and     Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in     nulliparous women.   "
40088|NCT02760875|"     Using a population of patients from another study, who was originally randomized to 2     different types of nonoperative treatment after an acute achilles tendon rupture, the length     of the achilles tendon is examined using ultrasound, and foot pressure mapping is performed,     4-5 years after the injury.   "
40089|NCT02760862|"     Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower     abdominal and pelvic surgery under spinal anesthesia were included in this randomized     double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received     intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received     intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours.     Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment     was assessed using visual analog scale.   "
40090|NCT02760849|"     The goal of this clinical research study is to compare the changes in female sexual function     between patients having interval salpingectomy with delayed oophorectomy (ISDO) with those     having risk-reducing salpingo-oophorectomy (RRSO) in women who carry genetic mutations.     Researchers also want to learn how these surgeries affect your quality of life.      RRSO is the standard surgery for patients with certain types of genetic mutations, where the     fallopian tubes and ovaries are removed at the same time.      ISDO is surgery to remove the fallopian tubes first, then the ovaries are removed during a     second, later surgery. Most women with genetic mutations will be encouraged to remove the     ovaries around the ages of 40 to 50. The decision in timing to remove your ovaries will be     made with your doctor.   "
40091|NCT02760836|"     The purpose of this study is to develop and validate a predictive model of clinical outcomes     based on the results of web-based self-reporting symptom diary for Crohn's disease.   "
40092|NCT02760823|"     The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an     adjuvant in the management of patients with acute phosphide poisoning.   "
40093|NCT02760810|"     This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid     pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a     14-day period.   "
40095|NCT02760784|"     A total of 56 patients completed a previous study regarding non-operative treatment for acute     achilles tendon rupture. This study consists of an additional follow up after 4-5 years     depending on original date of injury.   "
40096|NCT02760771|"     Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty     (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the     induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation aims     at facilitating the crossing of the aortic annulus, accurate valve positioning and does also     provide information on the anatomy of the valve complex. However, BAV has been shown to have     a number of potentially detrimental effects.      There is limited experience for the balloon expandable Edwards THV on the need for     predilation (BAV). Experience so far has only been documented from smaller, uncontrolled case     series.      The investigators aim to document the incidence of several kinds of complications in a large,     multicenter registry / prospective controlled cohort study to identify associations between     patient related variables and outcomes.   "
40097|NCT02760758|"     This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor     (NNI) in healthy volunteers and HCV infected individuals   "
40098|NCT02760745|"     Febrile shivering in the pediatric population is assumed to be related to a Severe Bacterial     Infection (SBI). Research supporting this assumption is scant. The purpose of this study is     to describe the frequency of febrile shivering in the pediatric population arriving at the     emergency department and to define its role in predicting a SBI.   "
40099|NCT02760732|"     This study was to investigate the effect and safety of drug eluting balloon combined for     treatment of unstable angina.   "
40100|NCT02760719|"     This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with     salbutamol in the treatment of children under 2 years, hospitalised for acute viral     bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution     with salbutamol three times daily, the other half will receive standard supportive care,     which is the cornerstone of the bronchiolitis management.   "
40101|NCT02760706|"     Study hypothesis: Post-processed SDCT images provide additional diagnostic value over     conventional CT datasets.      The CT examination would be a clinically-necessary, standard-of-care CT performed as per the     clinical indication. The protocol and scan parameters for the CT exam will be similar to that     of an equivalent scan performed with any other CT scanner. There would be no additional     scanner of injection of any drug specifically for the study. The conventional CT images     generated by the scanner will be used for clinical purposes as routinely practiced.   "
40104|NCT02760667|"     The objective of this study is to assess the efficacy of induction chemotherapy followed by     transoral surgical treatment and neck dissection, in definitive management of moderately     advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out     Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary tumor,     and neck dissection for the management of cervical lymph nodes.      The primary outcome measure will be disease specific survival (DSS). The secondary oncologic     outcome measures will be locoregional control, relapse free survival, overall survival, and     Quality of Life (QOL).   "
40105|NCT02760654|"     The purpose of this pilot randomized wait-list controlled trial is to test the efficacy of an     online cognitive behavioral pain management website called Proactive Self-Management Program     for Effects of Cancer Treatment (PROPSECT) to reduce worst pain intensity for individuals     with chronic painful chemotherapy-induced peripheral neuropathy (CIPN) and to explore the     mediating effect of PROSPECT-induced changes in anxiety, fatigue, depression, and sleep     disturbance on worst pain intensity. Another aim of this study is to determine whether     PROSPECT will decrease CIPN symptom severity (e.g. non-painful numbness and tingling),     average pain severity, and physical impairment. Lastly, since this intervention has never     been tested in individuals with painful CIPN, the investigators will assess patients'     perceptions of acceptability and satisfaction with the intervention.   "
40106|NCT02760641|"     The purpose of this study is to determine the effects of change in diet quality (carbohydrate     restriction versus fat restriction) on body composition, fat distribution, cardiometabolic     risk factors, physical function, and quality of life in aging adults with obesity.   "
40107|NCT02760628|"     The First Twenty® (TF20) was recently developed as a not-for-profit, web-mobile program for     firefighters (FFs) specifically focused on improving fitness and nutrition knowledge and     practices. The program was designed by FFs with backgrounds in tactical fitness, marketing     and program development professionals, and nutrition and exercise scientists. Preliminary     data suggests the program is well-received by FFs and results in significant improvement in     body composition and physical fitness. One innovative approach for the eventual dissemination     of TF20 to VFFs is through their fitness-for duty medical exams. The synergy created by     linking the TF20 intervention components, feedback to the VFFs from their medical exam, and     health messages from their physician is predicted to maximize the impact of this much-needed     intervention. The goal of the proposed project is to tailor TF20 for use in a clinic based     setting (CB-TF20) for VFFs and to pilot test it in comparison to the American Heart     Association's Life's Simple 7 (LS7), a web-based diet and physical activity     knowledge/behavior and lifestyle program. The specific aims are to: 1) Conduct formative     research with key stakeholders in the VFF community (e.g., physicians, department leadership,     VFFs) to determine best practices for implementing a clinic-based, web-mobile health and     wellness program with VFFs and medical providers; 2) Develop a clinic-based version of TF20     (CB-TF20) and beta-test it with VFFs; and, 3) Conduct a 6 month, 2-arm, pilot cluster (i.e.,     department) randomized clinical trial (PCRCT) to determine the comparative effectiveness of     the revised CB-TF20 to LS7 on body composition, Framingham Risk Scores, and diet/physical     activity knowledge and behaviors among VFF with BMI >25.0kg/m2; and conduct an evaluation of     the CB-TF20 materials and technology. This innovative R34 study is a critical step in     providing a much needed intervention for VFFs and those providing their annual examinations.   "
40108|NCT02760615|"     The purpose of this study is to evaluate in a step-wise approach the disease drug-drug     interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome     P-450 (CYP) substrate drugs by modulating pro-inflammatory cytokines in participants with     ulcerative colitis (UC) or Crohn's disease (CD) who are treated with vedolizumab.   "
40109|NCT02760602|"     The main purpose of this study is to investigate the safety and efficacy of the study drug     solanezumab in participants with prodromal Alzheimer's disease (AD).   "
40110|NCT02760589|"     The purpose of the study is a clinical evaluation with special regard to magnetic resonance     imaging and functional performance at least one year after injury / surgery in all three     groups (subjects who underwent InternalBrace surgery, subjects who underwent surgery with a     semitendinosus graft and subjects who were treated conservatively).   "
40111|NCT02760576|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
40112|NCT02760563|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
40113|NCT02760550|"     The objectives of this policy-related survey are as follows:      i. to study updated trend and prevalence on secondhand smoke, smoking-attributed health     effects, cessation services; ii. to investigate the level of public support on current and     future tobacco control measures and taxation policies; iii. to address the timely impacts of     smoke-free policies, substantiate public support on further tobacco control measures and     assist Hong Kong Council On Smoking and Health (COSH) in shaping policy direction for     government.      Purpose of the study is to provide evidence and support for smoke-free policy development in     Hong Kong.   "
40161|NCT02759926|"     In this study, the investigators aimed at evaluating the role of bitter taste receptors in     the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium     benzoate (DB) or quinine hydrochloride were compared with placebo administration for their     effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed state),     gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin     (CCK)) and food intake. Differences between lean and obese subjects will be evaluated.   "
40114|NCT02760537|"     The study was conducted between April 2013 and October 2014. In the parent study, 600     foreign-born Asian American adults 18 years of age and older were drawn from the community in     the Baltimore Washington Metropolitan Area. Using a non-probability sampling method,     foreign-born Asian American adults, 18 years of age and older, were recruited from the     community.      After providing informed consent, all the participants were asked to complete a     self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the     assistance of a bilingual interviewer when necessary. Then, all of the participants were     instructed and given 5 to 10 to minutes to read culturally integrated and linguistically     appropriate educational material (e.g., Photo novel) developed and validated for efficacy     from a prior study.      All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb     (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600     completed the survey and screening. A week later, they received the results of the screening     test. Based on the screening results, all participants were categorized into three groups:     (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We     sent the results by mail to participants who were unprotected and protected. Among those 600     screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335 (55.8%)     had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were susceptible     to HBV infection (unprotected).      LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were     randomly assigned to either the intervention (n=124) or the control (n=108) groups by     computer-automated random assignment. Randomization was used to assure equivalence between     groups on key factors that may potentially influence the outcome of HBV vaccinations: gender,     age, education, length of stay in the U.S.      LHWs conducted phone interventions by reminding participants of a series of vaccinations at     months 1, 2, and 5 among those assigned to the intervention group. Those in the control group     received a list of resources along with their results by mail that offered free vaccinations,     such as local health departments. Seven months after mailing the results, those unprotected     were followed up by phone to ask about their status of the series of vaccinations and about     promoters or barriers to vaccinations.   "
40115|NCT02760524|"     The major goal of this study is to determine whether Neuro-Emotional Technique is a viable     treatment option for decreasing distress in cancer patients. The potential advantages of NET     are: 1) it is designed specifically to address distressing stimuli and unresolved emotional     memories; 2) it is a brief, time-limited intervention; and 3) its multi-modal design may     appeal to and benefit a broader range of patients than a single mode intervention   "
40116|NCT02760511|"     Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the     epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently,     study of anthocyanin pigments has drawn more and more interest since several epidemiological     studies have demonstrated their health-promoting properties, such as reducing lipid     accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear     need for advancing understanding with regard to effective amounts of intake for these     phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of     anthocyanin in healthy volunteers.   "
40117|NCT02760498|"     To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal     or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally     advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central     review.   "
40118|NCT02760485|"     The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib     in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell     lymphoma (DLBCL)   "
40119|NCT02760472|"     Most fatty acids, important for development and especially the Omega-3 fatty acids for the     brain development are transferred in the third trimester with means that in the premature     infant this transport via the placenta is interrupted and the infant is dependent on the     concentrations in breast milk which vary depending on the mother's diet and her stores. It     has even been suggested that low Omega-3 would be a cause of premature delivery. Many     countries have much higher levels of Omega-3 fatty acids in breast milk than found in Sweden     and breast milk substitutions are generally now supplemented with the Long Chained Poly     Unsaturated Fatty Acids (LCPUFA). Therefore the supplementation to be given can not be seen     to give any risks for the infant. On the contrary, several studies have shown that mother who     eat equal to or less than twice fish a week during pregnancy give birth to infants with     impaired development.      Low Omega-3 levels in premature infants between gestational ages of 23 and 40 weeks can be     one reason for Retinopathy of Prematurity (ROP) development. Restoration of Omega-3,     Dokosahexaenacid (DHA) and Eikosapentaenacid (EPA) to normal in utero levels may prevent ROP     by allowing normal vessel growth and survival. An increase of Omega-3 levels bringing levels     to within physiological range may prevent development of ROP.   "
40120|NCT02760459|"     To compare the effects of perioperative intravenous Dexamethasone with a placebo on the     severity of persistent postsurgical pain after total knee arthroplasty.   "
40121|NCT02760446|"     Validity and Reliability of French Version of the Confusion Assessment Method for the     Intensive Care Unit (psychometric validation study after translation/back translation process     assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)   "
40122|NCT02760433|"     The purpose of this study is to determine how safe and effective the study drug Olokizumab     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully     responding to treatment with an existing medication called a tumour necrosis factor alpha     inhibitor   "
40123|NCT02760420|"     The purpose of this study to assess the effectiveness of no antibiotic treatment for fast     breathing, community-acquired childhood pneumonia in a malaria-endemic region of Malawi.   "
40124|NCT02760407|"     The purpose of this study is to determine how safe and effective the study drug Olokizumab     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully     responding to treatment with methotrexate (MTX).   "
40125|NCT02760394|"     Hyperbaric oxygen therapy (HBOT) is proposed as a possible in vivo angiogenic stimulator for     improving microvascular myocardial perfusion and anginal symptoms as assessed by myocardial     perfusion imaging and angina questionnaire in patients with chronic stable ischemic heart     disease, when no other means to relief symptoms and/or ischemia are available.   "
40160|NCT02759939|"     Right For Me is a study that aims to improve the conversations patients and health care     providers have about birth control. Right For Me will test two different strategies for     improving these conversations. The first strategy is to give patients a video to watch that     encourages them to ask three specific questions in their health care visit, as well as a     prompt card that reminds them of the three questions. The second strategy is to give health     care providers a set of decision aids that describe available birth control methods, as well     as training in how to use them with patients during the health care visit. Right For Me will     test whether introducing one or both of these strategies leads to better conversations than     providing health care as usual.   "
40126|NCT02760381|"     Adenomas and hyperplastic polyps are polypoid lesions that can occur in any part of the     colon. Currently all polyps should be resected endoscopically, however adenomas have the     potential to develop into colorectal cancer whereas hyperplastic polyps do not. This approach     enables the lesions to be evaluated under the microscope. Currently only the pathological     diagnosis can distinguish exactly between adenomas and hyperplastic polyps. Acetic acid (AA)     chromoendoscopy is already widely used in order to improve optical determination of mucosal     lesions in the upper gastrointestinal tract. In the colon only few studies investigated the     impact of AA in differentiating normal mucosa from suspicious mucosa. The aim of the present     study is to evaluate the value of spraying acetic acid as an adjunct for optical     characterization of colon polyps. Using AA may be beneficial for determining optical     diagnoses of colon polyps during real time colonoscopy. This is a single-arm proof of     principle study. If colon polyps are found during colonoscopy a 1.5 percent AA solution will     be used for chromoendoscopy. Endoscopists are encouraged to use the Narrow Band Imaging (NBI)     function of the endoscope prior to the use of AA. After AA is sprayed endoscopists will     diagnose the polyp optically. Endoscopists have to predict adenomatous or non-adenomatous     histology based upon optical features of the polyp. All polyps will be resected     endoscopically so that histopathological diagnoses can be determined. After completing the     trial the investigators aim to compare optical and histopathological-based diagnoses of     polyps. Histopathological diagnoses will serve as the gold standard. Based upon this     information the accuracy of the optical diagnoses will be calculated. The investigators     hypothesis is, that optical-based diagnosis using NBI and AA will be accurate in > 75% of all     polyp cases.   "
40127|NCT02760368|"     The purpose of this study is to determine how safe and effective the study drug Olokizumab     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully     responding to, treatment with methotrexate (MTX).   "
40128|NCT02760355|"     In this pilot study, the investigators plan to treat patients with chronic hepatitis C due to     HCV genotype 3 infection using an interferon-free regimen consisting in the administration of     ribavirin and sofosbuvir/ledipasvir - a combination of a nucleotide RNA polymerase inhibitor     with a non-structural protein 5A inhibitor. Patients will undergo a euglycemic     hyperinsulinemic clamp, using tracers, and indirect calorimetry to assess whether the viral     suppression induced by this regimen will be capable of reversing the glucose metabolic     alterations induced by HCV in both the liver and extrahepatic compartments. Adipose and     muscle tissue biopsies will also be performed to assess some specific molecular changes     induced by HCV.   "
40129|NCT02760342|"     The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K     and metformin in healthy non-elderly male subjects.   "
40178|NCT02759705|"     This analytical descriptive study aims to describe the fertility and sexuality male adult     subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk     factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual     self-esteem and a semen analysis will be realized at first consultation, semen analysis     results wil be explained at second consultation. It is assumed that fertility and sexuality     exstrophic men are impaired.   "
40130|NCT02760329|"     The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive     lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study     which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or     Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and     receive standard medical care as determined by their treating physician. Patients enrolled in     NOVELTY will be followed up yearly by their treating physician for a total duration of three     years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study     will collect data currently lacking to allow for multinational data collection to fill     regional/local gaps and improve comparability across regions.   "
40131|NCT02760316|"     A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple     ascending doses of AZD9567.   "
40132|NCT02760303|"     Adolescence and young adulthood may be particularly stressful developmental periods due to     the numerous transitions into new roles and the need for increased independence. Stress can     affect metabolic control in older adolescents and young adults with T1D directly through its     impact on cortisol and other hormones that affect insulin metabolism.      The proposed study is a pilot randomized clinical trial using a three-group randomized,     repeated measures design to assess the efficacy of two treatments (Mindfulness Based Stress     Reduction (MBSR) and Cognitive Behavioral Therapy or (CBT) versus an attention control     condition for older adolescents and young adults with poorly controlled Type 1 diabetes. As a     pilot study, the goal of the research is to test recruitment and retention procedures,     finalize intervention measures, training, and fidelity protocols, and estimate effect sizes     for a larger clinical trial.   "
40133|NCT02760290|"     Cesarean section will performed via intraperitoneally and extraperitoneally. During     postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel     movement, discharged time will be compared.   "
40134|NCT02760277|"     The main purposes of this study are to see if it is safe to use a new medication called     vamorolone for more than two weeks in children with Duchenne muscular dystrophy (DMD), to see     if vamorolone works for the treatment for DMD, and to see how any potential side effects     compare to those seen in boys using steroids.   "
40135|NCT02760264|"     The purpose of this study is to determine whether a new medication called vamorolone is safe     and well-tolerated by boys with Duchenne muscular dystrophy (DMD) ages ≥ 4 and < 7 years old.   "
40136|NCT02760251|"     The study aims to investigate immunomodulatory effects of thrombopoietin-receptor Agonist     (TPO-RA) in patients with primary ITP, who failed first-line therapy or who became intolerant     to it. It is hypothesized that the early phase of this autoimmune disease may exhibit a     stronger immunomodulatory potential in response to a stimulus, such as romiplostim. Such a     process may subsequently be capable to induce regulatory mechanisms or tolerance.      Romiplostim (a thrombopoietin-receptor agonist, TPO-RA) will be administered subcutaneously     once weekly over 22 weeks with a starting dose of 1mcg/kg body weight. The dose will be     adjusted based on platelet counts as described in the summary of Product Characteristics     (SmPC).   "
40137|NCT02760238|"     The mandate of this MPN registry is to collect clinical information, including molecular     results, from consenting patients with a variety of MPNs at different time points during the     course of their disease.   "
40138|NCT02760225|"     This is a two center, single arm, investigator sponsored trial (IST) with the PET tracer     89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-Pembrolizumab in a     registered indication: locally advanced metastatic melanoma or non-small cell lung cancer     before Pembrolizumab treatment.   "
40188|NCT02759575|"     The purpose of this research study is to test the safety and the benefit of adding     pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of     care treatment for cancer. The standard of care treatment will include chemotherapy and     radiation for 7 weeks.   "
40139|NCT02760212|"     Fibromyalgia is a common disorder affecting approximately 2% of the Canadian population.     Patients diagnosed with fibromyalgia commonly present with chronic, widespread pain as well     as fatigue, depression, mood disturbances, and cognitive symptoms. As a result, fibromyalgia     has a negative impact on the patient's quality of life, and a negative financial impact for     them, society, and the healthcare system, through lost wages and delayed diagnosis. Therefore     a more direct and conclusive method of diagnosis is needed.      Recently, fibromyalgia diagnosis has been based on the modified American College of     Rheumatology Preliminary Diagnostic Criteria for fibromyalgia. To assist with diagnosis,     recent evidence shows that compared to healthy people, people with fibromyalgia present with     differences on functional MRI (fMRI) whole brain scans, as well as differences in a     functional blood biomarker challenge test, known as fm/a. The fm/a determines the function of     the immune system in response to a stimulus, and has been used previously to show that people     with fibromyalgia have a severely blunted immune response.      Despite the number of treatment options available, interventions for chronic pain remain     largely ineffective. In light of its demonstrated effectiveness, safety, and ease of use in     previous studies, radial shockwave therapy (RSWT) has been selected for inclusion in the     present study. The main objective of this study is to determine the efficacy and effect of     RSWT compared to placebo on the symptoms frequently reported in association with     fibromyalgia. In addition, the fm/a and brain activity associated with pain patterns (fMRI)     may assist in early diagnosis and prediction of treatment success in patients with     fibromyalgia.   "
40140|NCT02760199|"     AMG 211 is a bispecific single-chain antibody construct of the bispecific T-cell engager     (BiTE®) class that targets human carcinoembryonic antigen (CEA, CD66e) on (tumor) cells and     cluster of differentiation 3 (CD3) positive T-cells. AMG 211 is a potentially new targeted     drug in the treatment of relapsed/refractory gastrointestinal adenocarcinoma, since those are     CEA expressing tumors. A well-known challenge in current drug development using targeted     therapies is the high level of heterogeneity of target expression that is present in specific     tumor types. Radio-labeling of AMG 211 with the positron emission tomography (PET)     radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of AMG 211     distribution in cancer patients. By performing a 89Zr-AMG211 PET scan prior to treatment with     AMG 211, the uptake of the tracer in the primary and metastatic tumor lesions and normal     organ distribution can be evaluated. By performing a 89Zr-AMG211 PET scan during AMG 211     continuous intravenous (cIV) treatment the investigators will be able to evaluate the impact     of prolonged steady state exposure of AMG 211 on tumor and tissue uptake. The 89Zr-AMG211 PET     imaging study may help to identify patients more likely to benefit from AMG 211 therapy.   "
40141|NCT02760186|"     Prospective interventional trial in lowlanders evaluating effect of acute exposure,     acclimatization and re-exposure to high altitude.   "
40142|NCT02760173|"     The long-term goal of this research is to advance our knowledge of how the brain combines the     information of multiple sensory systems coding for spatial orientation and how adaptation to     vestibular imbalance influences spatial orientation. In healthy human subjects verticality     perception is accurate while upright. After prolonged roll-tilt, humans show a systematic     bias in perceived direction towards the previous roll-tilted position (so-called post-tilt     bias). Here we evaluate different potential explanations for this bias using both     vision-dependent and vision-independent paradigms of verticality perception.   "
40143|NCT02760160|"     To assess the effect of orally administered grape powder on the sunburn reaction in humans.   "
40144|NCT02760147|"     The aim of this study is to evaluate the ventilator settings advice given by the BEACON care     system in fitting with best level of support in patient under mechanical ventilation in     Pressure Support mode.   "
40145|NCT02760134|"     Percutaneous nephrolithotomy (PCNL) is a well-established treatment modality for renal     stones. It offers a high stone free rates and less invasive than open surgery. Nevertheless     PCNL is an invasive and technically demanding procedure with inherent risks and     complications. The most troublesome morbidities are bleeding and injury to the kidney and its     adjacent structures. Complications of PCNL tend to be associated with the accuracy of tract     placement and the size of the nephrostomy tract. To improve the safety of PCNL, there is a     trend toward using smaller and smaller nephrostomy tracts . With the smaller nephrostomy     tract, there also arise the problems of compromised visual field and increased difficulty in     stone extraction. Increase irrigation using pressure pump might improve the visualization and     the passive egress of the stone fragments, but it also may concomitantly increase the     intra-luminal pressure.      The present system of Super-Mini percutaneous nephrolithotomy (SMP) was developed to address     many of these deficiencies. The basic components of SMP system are an 8.0 F miniaturized     nephroscope with a newly designed irrigation-suction sheath with enhanced irrigation     capability and modified nephrostomy sheath with continuous negative pressure aspiration. Its     design was intended not only to prevent the excessive intrarenal pressure but also improve     the visualization and the stone fragments extraction.      Little was known about renal pelvic pressure in vivo during SMP and about any correlation it     might have had with postoperative fever and urosepsis. We measure the renal pelvic pressure     during SMP to determine whether it will improve the renal pelvic pressure and improve the     incidence of postoperative fever.   "
40146|NCT02760121|"     The purpose of this proposal is to compare the physiological effects of acetazolamide (AZ)     and methazolamide (MZ) on the control of breathing and hypoxic pulmonary vasoconstriction.     The first objective is to assess the effects of AZ and MZ on the control of breathing in     normoxia and hypoxia. To achieve this the ventilatory interaction between oxygen and carbon     dioxide will be measured and effects compared between placebo, AZ, and MZ conditions. In     addition, the isocapnic and poikilocapnic hypoxic ventilatory response and hypercapnic     ventilatory response will be measured with each drug. The second objective is to assess the     effects of AZ and MZ on the control of the pulmonary vasculature during hypoxia. Pulmonary     pressure and cardiac output will be measured during 60 minutes of poikilocapnic hypoxia.   "
40189|NCT02759562|"     This primary objective of this study is to the effect of andecaliximab (GS-5745) on     pre-bronchodilator forced expiratory volume in 1 second (FEV1) in adults with cystic fibrosis     (CF) after 8 weeks of treatment.      There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be     administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be     administered for 8 weeks. Part 2 will be initiated after completion of Part 1.   "
40147|NCT02760108|"     One person in every 500 has Parkinson's and around 127,000 people are living with the     condition in the UK. The aim of the study is to identify new genes that predispose or cause     Parkinson's Disease or Parkinsonism. There is a pressing need to study the genetic makeup of     family members both with and without Parkinson's. As families share a common genetic     background, it is easier to find new Parkinson's genes by studying the genetic makeup of     people with Parkinson's alongside other members of their families. We are particularly     interested in studying the genetic makeup of two groups of people:        1. those who developed Parkinson's before the age of 45; and        2. those who have a family history of other relatives affected by Parkinson's.      By identifying genetic factors that cause Parkinson's, we hope to understand more about the     condition. Doing so will lead to the development of better diagnosis, improved disease     models, and we hope in time, to the development of better treatment.   "
40148|NCT02760095|"     The overall objective is to determine the impact of EED on zinc absorption and homeostasis,     and its impact on the absorptive capacity of vitamin A absorption of young children (18-24     months of age) in an austere setting with high rates of diarrhea, stunting, and     micro-nutrient deficiencies.   "
40149|NCT02760082|"     The study will based on qualitative methods investigate motivational factors among patients     diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress     provoking factors and physical activity (NESPA). The aim is to gain knowledge on motivational     factors for using a digital tool for collecting data on NESPA and incorporate this knowledge     into a form which can be used in requirement specifications for such a digital tool.   "
40150|NCT02760069|"     This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with     three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl     alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.   "
40151|NCT02760056|"     This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3)     in subjects with multiple sclerosis   "
40152|NCT02760043|"     This study will evaluate if the addition of dexamethasone to a local infiltration analgesia     mixture will improve functional outcomes following total hip and knee arthroplasty.   "
40153|NCT02760030|"     This phase II clinical trial studies how well fulvestrant and palbociclib works in treating     older patients with breast cancer that responds to hormone treatment (hormone responsive)     that cannot be removed by surgery. Estrogen can cause the growth of     estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight     estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells.     Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for     hormone responsive breast cancer.   "
40179|NCT02759692|"     Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical     performance of two FDA-approved contact lens.   "
40180|NCT02759679|"     The study aims to optimize and define a reproducible and non-invasive method for canine     assisted lung cancer detection, using human breath samples from patients and controls for     training and testing purposes.   "
40154|NCT02760017|"     Among the plants most used in folk medicine for the treatment of diabetes are the species of     the genus Bauhinia (Fabaceae), popularly known in Brazil as pata-de-vaca. Of these,     Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Due     to this fact it is included in the Medicinal Plants List of the Brazilian Public Health     System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its     chemical composition and its pharmacological potential. From the chemical point of view the     main components identified in hydro alcoholic extract of the leaves are O-glycosylated     derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical     studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic extract     of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic activity     of B. forficata in clinical level was performed in only two studies, both with few patients,     and questionable methodological quality that used tea as a pharmaceutical form, a fact that     allows us to question the validity of data considering the risks of no dose reproducibility     ingested by patients during the study. Thus the investigators here intend to determine the     effects of a standardized extract of B. forficata in the control of patients with diabetes     mellitus   "
40155|NCT02760004|"     The primary goal of this study is to develop, evaluate, and share a new low-cost program for     Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for     women during pregnancy and after childbirth.   "
40156|NCT02759991|"     The aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in     women of child bearing age in preventing HEV disease during pregnancy among women in rural     Bangladesh.   "
40157|NCT02759978|"     Infective endocarditis (IE) is a frequent and serious complication of implanted intracardiac     prosthetic material, with a high morbidity and mortality. Therefore, this study aims to     improve outcome of IE, with a focus on patients with intracardiac prosthetic material. In     this study the investigators deal with research questions about both the diagnosis     (microbiological, imaging, and expert opinion) and treatment of IE (with antimicrobial agents     and surgical), in order to improve these clinical components and ultimately aim to improve     outcome.   "
40158|NCT02759965|"     The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within     48 hours after elective hip surgery and that there is an association between exaggerated CNS     inflammatory response or impaired inflammatory resolution and postoperative cognitive     dysfunction within one week and at three months postoperatively.   "
40159|NCT02759952|"     Mutations in the PDE6A gene - encoding the -subunit of the rod cGMP-phosphodiesterase -     account for 1% of autosomal recessive retinitis pigmentosa (arRP) through impaired regulation     of cGMP levels in the rod outer segment. This study aims for a detailed clinical     characterization of patients with PDE6A mutations in preparation of a clinical gene     replacement study (phase I/II safety trial).   "
40307|NCT02758028|"     The aims of the present study are:        1. To raise the awareness of smoking cessation service among youth smokers in Hong Kong;        2. To provide smoking cessation quitline service to youth smokers; and        3. To provide training to teenagers as peer smoking cessation counsellors.   "
40162|NCT02759913|"     Prospective multicenter study of subjects who were recently diagnosed with amyotrophic     lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord diseases,     muscle diseases and neurological diseases such as multiple sclerosis, multifocal motor     neuropathy, myasthenia gravis and spinal muscular atrophy) or who are currently undergoing     diagnostic procedures for the aforementioned diseases.      Approximately 300 subjects will be enrolled. Subjects will undergo a lumbar puncture (LP) for     cerebro-spinal fluid (CSF) collection; blood collection for serum, plasma, RNA, and DNA     (optional); urine collection (optional); and skin biopsy (optional) in a single visit. No     study treatment will be administered.      Subjects will be managed and treated by their respective physicians; choice of therapy or     laboratory tests will not be impacted by the study. Clinical diagnosis may be confirmed by     the subject's physician and communicated to the study's Principal Investigator (PI) by     scheduled telephone calls.   "
40163|NCT02759900|"     This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment     of a number of different skin disorders   "
40164|NCT02759887|"     In order to treat individuals with Down syndrome (DS) better and more efficiently and to gain     more insights on its relation to Alzheimer's disease (AD), a comprehensive understanding is     needed for its progression in the early or preclinical phase using various biomarkers. DS is     a significant risk factor for the early development of AD, with plaques and tangles typically     developing by age 35. A better understanding is needed of early markers of the disease in DS     patients. Additionally the DS population represents a unique group - due to this elevated     risk for AD - to examine biomarkers that may translate in general outside of the DS     population to individuals at risk for developing late onset AD. In this proposal, the     researchers will assess the longitudinal changes of various biomarkers in a cohort of     individuals similar in design to the cross-sectional sectional study in the preliminary data.   "
40181|NCT02759666|"     This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to evaluate     the safety and tolerability of SHR3162 in participants with advanced solid tumors.   "
40296|NCT02758171|"     The primary objective of this trial is to investigate the bioequivalence of one fix dose     combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination     of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single     dose under fasted conditions.   "
40165|NCT02759874|"     The Institute of Health Economics is conducting a study to determine how a breathalyzer     linked to a cloud based alcohol monitoring system changes alcohol consumption during     pregnancy in women with alcohol dependency issues.      IHE posits that the ability to self-monitor blood alcohol concentration and the ability to     share sobriety via email or text with loved ones and counselors may reduce alcohol     consumption and thus reduce the possibility of delivering a child with FASD.      The study will provide useful evidence for tailoring future optimal maternal and child     healthcare for women, with the potential of decreasing healthcare utilization by prevention     of FASD. Breathalyzer device usage plus secure document sobriety should improve patient     monitoring convenience and demonstrate reductions in alcohol use outside of traditional     office visits and patient self-reports.   "
40166|NCT02759861|"     To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with     Genotype 1 HCV infection   "
40167|NCT02759848|"     Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD)     has not been well known. This study was designed to investigate the effects of history of TB     on the long-term course of COPD.   "
40168|NCT02759835|"     Background:      Some non-small-cell lung cancers (NSCLC) have a mutation in a gene that makes a protein     called EGFR. This particular cancer can be treated with certain drugs such as Erlotinib     (Tarceva), Gefitinib (Iressa) and Osimertinib (Tagrisso). But many tumors become resistant to     these drugs because of a second mutation. Researchers want to test if adding local ablative     therapy (LAT) extends the benefits of the drug, Osimertinib. LAT can include techniques such     as surgery, radiofrequency ablation, cryotherapy or radiation therapy.      Objective:      To test if re-taking osimertinib after LAT is safe, tolerable, and effective for people whose     NSCLC has progressed after initial treatment with osimertinib.      Eligibility:      Adults ages 18 and older with certain types of NSCLC. Participants will be divided into     various groups as described below.      Design:      Participants will be screened with:      Medical history      Physical exam      Blood, urine, and heart tests      Tumor scans      Eye exam      Review of tumor sample.      Participants will take the study drug by mouth once a day. They will continue until they can     no longer tolerate it or their disease worsens. They will keep a dosage diary.      All participants will start each 21-day course with physical exam; blood, urine, and saliva     tests; and electrocardiogram. They will have scans every 6 weeks and echocardiogram every 3     months.      Groups 1 and 2 will:      Start osimertinib right away.      Have LAT if their disease gets worse and is suitable for LAT. If LAT cannot be performed or     LAT consists of a procedure other than surgery, a tumor biopsy will be performed.      Re-start osimertinib after LAT, or other treatments if not suitable for LAT.      Group 3 will:      Have LAT.      If LAT consists of a procedure other than surgery, a tumor biopsy will be performed.      Start osimertinib after LAT.      After participants stop taking the drugs, they will have a final visit. This will include:      Medical history      Physical exam      Heart and blood tests      Participants will be called every year for follow-up.   "
40169|NCT02759822|"     This is a prospective observational cohort study of haploidentical transplantation with     post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning for     acute myeloid leukemia (AML) and myeloablative conditioning for acute lymphoblastic leukemia     (ALL).   "
40170|NCT02759809|"     In Canada, the leading cause of long-term disability in children is being born at very low     birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant     care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement     of donor milk or preterm formula as not enough mother's milk is available. As the ideal     supplement for prolonged feeding and its long-term effects is currently unknown, this study     is a prospective follow up of VLBW infants who in hospital were fed: donor milk or preterm     formula and/or mother's milk. Areas of development to be assessed include: cognition,     language, motor skills, brain structure/function, and body composition. A DNA biorepository     will also be created.   "
40171|NCT02759796|"     It is a single-center, prospective, randomized and controlled study focused in microsurgical     autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography     for the study of the vascularization of DIEP flaps. The aim of the study is to determine     whether there are differences in complications and aesthetic results when ICG is used to     discard the poorly vascularized areas of the flap. The study includes adult women undergoing     unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There     are two groups. In group 1, the investigators use the usual clinical criteria to discard the     poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the     flap.   "
40172|NCT02759783|"     Metastatic spread of cancer from its primary site to distant organs is the commonest cause of     death from cancer. The term oligometastases describes an intermediate metastatic state, in     which cancer exists as a limited number of metastases at first, before cells acquire the     ability to metastasise more widely. For the large majority of solid cancers, once metastatic     disease has been diagnosed the chances of cure are small. There are several situations where     this is not the case, but it is not known if stereotactic body radiotherapy (SBRT) for     oligometastatic disease will alter outcomes or whether the toxicity burden of this treatment     is justified. SBRT is targeted radiotherapy which destroys cancer cells in the area of the     body it is aimed at however low dose radiation may be received by surrounding tissue.      It is difficult to quantify incidence of patients with multiple primary cancers developing at     intervals that are representative of oligometastatic stage IV disease, (defined for the     purposes of this trial as ≤ 3 metastatic sites). However an increase in the use of     surveillance imaging, together with improved diagnostic sensitivity has led to the diagnosis     of patients with asymptomatic oligometastatic relapse becoming a more common clinical     occurrence. The CORE study is a randomized controlled trial that will be conducted in     patients with cancer in one of three primary sites where oligometastatic disease relapse is a     common clinical scenario: breast, prostate and non-small cell lung cancer (NSCLC). The study     will evaluate the use of SBRT in this patient population.      Eligible patients who consent to participate in this clinical trial will be randomized to     receive standard care or standard care plus SBRT we hope to recruit approximately 206     patients to the study and the primary outcome measure is progression free survival.   "
40210|NCT02759289|"     Investigators will recruit 250 subjects; Group A will consist of 100 prediabetic patients     with an A1c of 5.7%-6.4%. Group B will consist of 100 patients with uncontrolled T2D defined     as either a) an A1c of 6.5%-7.9% without diabetes medications or b) an A1c ≥ 8.0% with or     without diabetes medications. Group C will include 50 participants without T2D or known     cardiovascular disease to serve as control comparisons.   "
40211|NCT02759276|"     Nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and inflammatory     biomarkers have been used to study endothelial function in patients with resistant     hypertension, stages 1 and 2 hypertension and normotensive. This was a cross-sectional study.   "
40173|NCT02759770|"     Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis     of patients; the mortality is up to 40%. Although experience many years of research and     exploration, the effective methods for the treatment of acute respiratory distress syndrome     is still relatively limited at present, including lung protective mechanical ventilation     respiratory support, fluid management, glucocorticoid and other integrated organ function     maintenance measures. It is currently the research of acute respiratory distress syndrome     aims at the early discovery and takes effective measures to prevent its occurrence, hoping to     improve the prognosis of patients. According to risk factors is established through the     analysis of lung injury score early warning system, the early identification of acute     respiratory distress syndrome patients at high risk, before the occurrence of acute     respiratory distress syndrome take corresponding preventive measures can effectively reduce     the incidence rate and mortality. So far, domestic and foreign research on the establishment     of acute respiratory distress syndrome scoring early warning system is less. Cardiac surgery     has significant characteristics, type of operation, location, operation, intraoperative blood     transfusion and oxygenation, postoperative factors, are likely to be the factors of acute     respiratory distress syndrome. As far as investigators know, so far there are few specialized     for acute respiratory distress syndrome predicting lung injury after cardiac surgery. This     study will be completed after the implementation of individualized dynamic lung injury score     evaluation of cardiac surgery patients, identification of high-risk acute respiratory     distress syndrome patients, to assist clinicians in early decision, take preventive measures.     This study will improve the prognosis of acute respiratory distress syndrome patients after     cardiac surgery; it is of great significance to improve the level of intensive care after     cardiac surgery.   "
40174|NCT02759757|"     Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal     of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain.      Study design: Three-arm, randomized controlled trial with a blinded assessor.      Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID)      Patients: Sixty-three patients with chronic nonspecific low back pain.      Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as     described by the manufacturer's manual. The patients assigned to the placebo group will     receive a Micropore tape and the control group will not receive any intervention. All groups     will be assessed before and 30 minutes after intervention      Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity.      Limitations: Therapists will not be blinded.   "
40175|NCT02759744|"     Background:      Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less     aggressive disease are limited. Researchers want to test a device that destroys cancerous     tissue with laser energy. They want to see if using it with ultrasound is more comfortable     than using it with magnetic resonance imaging (MRI).      Objectives:      To test a cooled laser applicator system to treat prostate cancer lesions. To see if     ultrasound imaging is a practical and feasible treatment with laser ablation for focal     prostate cancer treatment.      Eligibility:      Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.      Design:      Participants will be screened with standard cancer care tests. These can include physical     exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures.     Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the     prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the     rectum.      Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be     put in the bladder. Ultrasound will guide the laser applicator directly to the tumor.      The cooling catheter will be removed. A different catheter will be put in the urethra to keep     the bladder emptied.      The next day, participants will have a physical exam and a PSA blood test.      Participants will have 6 follow-up visits over 3 years. At each visit, they will have a     physical exam and lab tests. At some visits, they will also have an MRI or other scans and a     prostate biopsy.   "
40186|NCT02759601|"     This study is being carried out to assess the best dose of a new drug, called tefinostat, in     treating liver cancer.      Tefinostat is a new drug that blocks enzymes called histone deacetylases (pronounced     dee-as-et-isle-azes). Cells need these enzymes to grow and divide. Blocking them may stop     cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors or     'HDAC inhibitors'.      Tefinostat has never been given to patients with liver cancer before so we don't know which     dose is best at treating liver cancer. To find this out we will be testing one dose and if     that is safe we will then test a higher dose and so on. Eventually we will find the best     dose; we do not know when this will be. When we find the best dose we will treat another 39     patients with this dose.      The aim of this study is to find the best dose of tefinostat without causing side effects. We     will be looking closely at any side effects you might experience from this treatment.   "
40176|NCT02759731|"     Background:      Chronic graft versus host disease (cGVHD) can affect people who had a hematopoietic stem cell     transplant using donor cells. It is often fatal. It is usually treated with high doses of     steroids. But that helps only about half the people in the long term. Researchers want to see     if a drug called baricitinib can help people with cGVHD that has not responded to therapy.     The drug inhibits the proteins involved in communication in the immune system. These proteins     may play a role in cGVHD and other inflammatory diseases.      Objectives:      To test the safety and effectiveness of baricitinib in people with cGVHD that has not     responded to therapy.      Eligibility:      Adults 18 and older with cGVHD that has not responded to therapy.      Design:      Participants will be screened with a medical history, physical exam, and blood and urine     tests. They will have lung and heart tests and chest scans.      Baseline visit: Participants will have:      Medical history      Physical exam      Blood tests      Tests for infectious diseases      Skin, eye, and teeth evaluations      Rehabilitation and occupational medicine evaluations      Photos of any lesions      Gynecology evaluation (females)      The study will occur in 28-day cycles. Participants will take the study drug by mouth every     day for 3 cycles. Some will take it for 3 or 6 more cycles.      Participants will have a few visits during each cycle. They will repeat some previous tests.     They may also have scans and questionnaires.      Participants will have a visit when they stop taking the drug and another 3 months later.     They will repeat a few study tests. They will have follow-up calls for 2 years.   "
40177|NCT02759718|"     Chromogranin A (CgA) is a glycoprotein with a molecular weight of 49 to 52 kDa produced by     chromaffin cells of the adrenal medulla, enterochromaffin-like (ECL) cells, and endocrine     cells of the stomach and pancreas, and it is the precursor to several functional peptides     including vasostatin and pancreastatin.      Importantly, CgA can be measured in the serum or plasma or detected within the secretory     vesicles as a general diagnostic biomarker for neuroendocrine tumors (NETs), and plasma CgA     levels also provide information regarding tumor burden and response to treatment. It has a     sensitivity and specificity between 27% and 81%.      Some studies have noted an association between CgA concentrations and tumor location or     degree of differentiation. It has also been proposed that plasma CgA levels are more     frequently elevated in well-differentiated tumors compared with poorly differentiated tumors     of the midgut. Some other clinical series have provided evidence of an association between     plasma CgA levels and the extent of disease, tumor burden, or presence of metastases, and     high baseline levels of CgA are suggestive of a poor prognosis.      However, there exist still controversies the effectiveness of serum CgA levels on diagnostic     relevance, treatment response after surgical resection or sandostatin analog,     clinicopathologic features of pancreatic neuroendocrine tumors (PNETs).      To date, moreover, a precise association between CgA levels and survival has not been clearly     demonstrated, although a number of studies suggest that this relationship may exist. There,     especially, is no relevant data on value of serum CgA level for clinical usefulness in Korean     population.   "
40223|NCT02759120|"     The purpose of this study is to compare the effect of standard care, versus standard of care     plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients     diagnosed with idiopathic pulmonary fibrosis (IPF).   "
40182|NCT02759653|"     BACKGROUND: In 30-40% the cause of ischemic stroke remains undetermined. Most likely, this     category hides an additional number of strokes caused by artery-to-artery embolisms due to     unidentified atherosclerotic disease, or caused by cardioembolism. Both types are associated     with a high risk of recurrent ischemic events and multiple cerebral infarctions.      Large-artery atherosclerosis of the brain-supplying arteries is the assumed underlying cause     in 10 to 15% of ischemic stroke, mostly deriving from the extracranial carotid artery.     Carotid intima-media thickness (cIMT) measured by 2-dimensional (2D) B-mode ultrasonography     and estimation of the overall atherosclerotic plaque burden aids future risk prediction.     Arterial wall changes, artery caliber variations, degree of stenosis, local hemodynamic     alterations and certain plaque characteristics are important for the evaluation of plaque     vulnerability and vascular risk stratification. Transcranial Doppler monitoring (TCDM) is a     non-invasive bedside examination eligible for detection of microemboli in the human cerebral     circulation.      HYPOTHESIS: Atherosclerotic stenosis and plaque characteristics can be more accurately     assessed by the combination of routine 2D ultrasound, contrast enhanced ultrasound (CEUS),     and 3-dimensional (3D) ultrasound. TCDM, CEUS and 3D visualization of the carotid plaque     improve the differentiation of stroke etiology and quantification of plaque vulnerability,     and aid the prediction of future risk for cerebrovascular events in the individual patient.      AIMS: Assessment of prevalence and frequency of Microemboli signals (MES) in unselected     patients with cerebral ischemia, the influence of antithrombotic drugs on MES, and the     relationship between MES and recurrent stroke or Transient ischemic attack (TIA).      Categorization of atherosclerotic carotid artery disease by use of routine and advanced     neurosonographic techniques combined with anamnestic and clinical data.      Development of a visualization solution tailored for 3D visualization of carotid arteries and     semi-automatic plaque segmentation.   "
40183|NCT02759640|"     This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects     with solid tumors. HS-10241 will be administered orally once daily.   "
40184|NCT02759627|"     Stroke is one of the major cause of morbidity and mortality and the leading cause of     disability in adults all around the world. Stroke survivors can suffer several neurological     impairments and deficits which have an important impact on patient's quality of life and     which increase the costs for health and social services. After stroke, impairments in ADLs     and functional status, deterioration in health related quality of life can be seen.      Although most of the stroke survivors experience some level of neurological recovery, nearly     50%-60% of stroke patients still experience some degree of motor impairment, and     approximately 50% are at least partly dependent in activities-of-daily-living (ADL). Gait     recovery, performing activities of daily living and regaining independence in ADLs are the     main focus of stroke rehabilitation programs.      Robotic technologies are becoming more promising techniques for the locomotor training in     stroke patients. Achieving a functional walking level is one of the target of robotic gait     training and it has been shown that Robotic-Assisted Gait Training (RAGT) improves walking     function in stroke patients. Having a functional gait level may help the stroke patients to     regain independence in ADLs and improve quality of life.      The purpose of the present study was to investigate the effects of RAGT on functional status,     ADLs and health related quality of life.   "
40185|NCT02759614|"     This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be     randomly assigned to treatment group (1:1) through a dynamic randomization process with use     of the following stratification factors: sex (female/male), disease stage (stage IIIb vs.     stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).   "
40187|NCT02759588|"     The purpose of this study is to determine if GL-ONC1 oncolytic immunotherapy is well     tolerated with anti-tumor activity in patients diagnosed with recurrent ovarian cancer and     peritoneal carcinomatosis.   "
40190|NCT02759549|"     The purpose of this study is to determine if an avatar-based depression self-management     intervention (eSMART-MH) once a week for the duration of the participant's radiation     treatment will significantly reduce depressive symptoms. Investigators also seek to explore     how women with breast cancer describe their mood using prompted and unprompted speech through     electronic social media and interviews.      Participants will be randomized into the eSMART-MH group or the theater testing (attention     control) group. In addition to the assigned interventions, participants will be asked to     complete questionnaires and interviews with the study staff.   "
40191|NCT02759536|"     Boron Neutron Capture Therapy (BNCT) has been used in the treatment of several types of     malignant tumors, including malignant melanoma, high-grade gliomas, and advanced head and     neck cancers. Theoretically, it represents a more precise radiotherapy in that it could spare     normal cells while destroy malignant ones. However, its value is largely restricted by the     fact that it could only be performed in the nuclear research reactors, the only neutron     source at the time. In 2010, the world's first in-hospital neutron irradiator (IHNI) had been     constructed in Beijing, China, and this study aims to evaluate whether IHNI has the potential     to serve as an effective in-hospital neutron source for BNCT.   "
40274|NCT02758457|"     The objective of this study was to compare the 5-year survival and clinical behavior of     single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal     framework. If failures occurred, the further aim of the study was to delineate the factors     contributing to the failure. The null hypothesis stated that the survival of zirconia-based     restorations would be no worse that those made with metal-based material.   "
40192|NCT02759523|"     Increased portion sizes of foods high in energy density (calories per gram of food) have been     implicated in the obesity epidemic. Numerous studies show that children and adults eat more     from larger portions of food than they do from smaller portions, a response known as the     portion size effect. Despite the robust and consistent nature of these findings, the     mechanisms underlying the portion size effect are not known. The long-term goal of this     research is to identify the neural mechanisms involved in the portion size effect so that     this information can be used to develop effective weight-management strategies. Differences     in neural response to food cues, as demonstrated by functional magnetic resonance imaging     (fMRI), can help clarify the factors that determine susceptibility to large portions. The     goal of this study is to identify brain regions activated in response to portion size and     energy density and relate these neural responses to laboratory eating behaviors in children.      The investigators hypothesize that high relative to low energy density food images will be     associated with increased activation in regions of the brain involved in reward- and sensory-     processing and that large relative to small portion size food images will be associated with     increased activation in regions of the brain involved in cognitive control. In addition, the     investigators hypothesize that these brain responses will influence the relationship between     portion size served and energy intake at laboratory meals.   "
40193|NCT02759510|"     Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in     obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral     vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in     cardiac output (CO) reduction.Norepinephrine acts not only as an α adrenoceptor receptor     agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure     the same asphenylephrine, meanwhile produce positive inotropic effect including increasing     heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid     the decline of CO. The purpose of this study is to evaluate the effect of norepinephrine and     phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.   "
40194|NCT02759497|"     One of the most common and serious complications in decompensated cirrhotic patients (DCPs)     is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial     peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections,     pneumonia and cellulitis.      Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly     produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and     macrophages can also produce these proteins. The induction of SAA and CRP synthesis is     triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell     types, but mainly from macrophages and monocytes at inflammatory sites   "
40195|NCT02759484|"     The MATCH2 Study (The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension) is     a randomized controlled trial comparing two educational approaches to improve glucose and     blood pressure control in African American and Latino adults with type 2 diabetes. The study     is being designed and implemented using a Community Based Participatory Research approach to     optimize the two educational approaches. One approach, Enhanced Home Based Education, adapts     a Community Health Worker (CHW) intervention from the protocol of the prior Mexican-American     Trial of Community Health workers (MATCH). The other approach, Enhanced Clinic Based     Education, uses a Certified Diabetes Educator (CDE) to deliver dietary and general     self-management education. The study seeks to determine if Community Health Workers working     as part of the primary care clinical team can reduce health disparities and improve outcomes     among patients with type 2 diabetes.   "
40196|NCT02759471|"     This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing     study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens     (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit,     subjects will return for follow-up evaluations after 2 weeks, and 1 month.      Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison     lenses.   "
40228|NCT02759055|"     Nearly one in three adults has prediabetes, a condition that substantially increases the risk     of heart attacks and stroke. The increased cardiovascular risk associated with prediabetes     can be effectively managed by lifestyle changes or medication therapy, but recent data shows     few prediabetes patients are treated effectively. In this project, we will adapt, implement,     and evaluate a proven electronic health record-linked, web-based clinical decision support     system to identify patients with prediabetes and provide prioritized treatment     recommendations to patients and providers in a rural health system. The results of the     project will provide a template for implementation of more efficient and effective rural     healthcare and have the potential to substantially and improve cardiovascular quality of care     and clinical outcomes of millions of rural Americans with prediabetes.   "
40197|NCT02759458|"     The purpose of the proposed study is to evaluate a new anchor for rotator cuff repair, the     Smith & Nephew Healicoil anchor. This anchor utilizes a small open-construct design to     promote bone-in growth and potentially allow for the release of bone marrow factors into the     repair site. In vivo ovine studies comparing the Arthrex BioComposite Corkscrew FT rotator     cuff anchor to the Arthrex SwivelLock anchor have shown superior bone in-growth.      Thus, this study consists of three separate aims in order to clinically and biochemically     investigate the capabilities of the Healicoil anchor and its efficacy in rotator cuff repair.     One, evaluate the bone in growth of the anchor compared to a standard poly-ether ether ketone     (PEEK) anchor. Two, analyze the marrow elements that are released into the repair site     through the open construct. Three, compare the functional outcomes of patients with rotator     cuff repairs using the Healicoil anchor compared to a traditional Twinfix PEEK anchor.   "
40198|NCT02759445|"     Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac     dysfunction. In general, patients consuming alcohol more than five years are at risk for the     development of dilated cardiomyopathy. As only few data about immediate changes in left     ventricular function after acute excessive alcohol ingestion are available, this study sought     to close this gap.      Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12     hours after alcohol excess and after 4 weeks of complete alcohol abstinence. Echocardiography     will performed at baseline and at follow-up regarding conventional parameter [as left     ventricular ejection fraction (LVEF), transmitral early (E) and late (A) Doppler flow     velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation time (IVRT)] and     myocardial deformation data [as layer specific global circumferential (endo GCS, mid GCS, epi     GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain].   "
40275|NCT02758444|"     The overall objective is to determine the impact of EED on total daily zinc absorption of     young Bangladeshi children (18-24 months of age) in an austere setting with high rates of     diarrhea, stunting, and micro-nutrient deficiencies..   "
40291|NCT02758236|"     This study is a prospective observational cohort study of TB patients who are treated or     evaluated at 7 study sites. Patients presenting with cough for 2 weeks or longer with at     least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be     enrolled in the study. The signed informed consent will designate their willingness to     participate on this study.   "
40199|NCT02759432|"     Low-volume high-intensity interval exercise training may improve aspects of health and     fitness in young people, but the effect of this type of exercise on quality of life has yet     to be assessed. The investigators aim to examine the effect of a 4-week school-based     low-volume high-intensity interval training programme (called the Fun Fast Interval Training     [FFIT] activity project) on physical fitness and quality of life in adolescent school pupils.     Approximately 145 English adolescents aged 11-12 years will be approached and invited to take     part in the study. Participants will be healthy female volunteers, recruited from one school     in Northeast England. Using a non-randomised design, one school year group will be assigned     to take part in the intervention, and a second year group assigned to the control     condition.Those in the intervention group will complete a 4-week school-based high-intensity     interval exercise training programme. The intervention will take place twice per week, and     comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and     basketball drills), each interspersed with 90-s rest. Participants will be encouraged to work     maximally during the 45-s repetitions. Control participants will be instructed not to change     their lifestyle, dietary or physical activity habits during the intervention period, and     maintain their normal school physical education routine. Study outcomes will be 20 m shuttle     run test performance, health-related quality of life, standing broad jump performance, hand     dynamometer performance, waist circumference and 10 m and 20 m sprint performance.   "
40200|NCT02759419|"     To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored     trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these     trials until lack of patient benefit as assessed by investigator, or commercial availability     and reimbursement.   "
40201|NCT02759406|"     This is a six (6) month, randomized, un-blinded, study to assess the safety and performance     of the Palmaz Mach-5 Grooved Coronary Stent System vs. the Palmaz Bare Metal Coronary Stent     System.   "
40202|NCT02759393|"     The purpose of this study is to investigate whether dexlansoprazole can be as effective as     double dose PPI to achieve SSR in high BMI cases with reflux esophagitis in Los Angeles     grades A & B.   "
40203|NCT02759380|"     The purpose of this study is to evaluate if a diet with a high content of phytoestrogens can     slow down the prostate tumor proliferation. Phytoestrogens are found in food items such as     soy, rye, and seeds.      Two hundred thirty men with prostate cancer will be included in the study and followed until     surgery (at least 6 weeks). Half of the study participants will receive general information     about healthy food choices and a package of foods with high content of phytoestrogens to add     to their food. The other half will get the same information but not receive the food-package.   "
40204|NCT02759367|"     This study evaluates the safety of increasing dietary potassium intake in a hypertensive     population that may be at risk for hyperkalemia.   "
40205|NCT02759354|"     To describe long-term persistence of Hepatitis B and pertussis antibody responses in healthy     4- to 5 Year old children previously vaccinated with VAXELIS or INFANRIX hexa   "
40230|NCT02759029|"     Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy     are declining, and an alternative strategy is needed urgently. The investigators sought to     compare the efficacy of pretreatment antimicrobial susceptibility-guided vs.     clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a     region with high rates of multiple drug resistance.   "
40231|NCT02759016|"     Intravenous BI 836826 in combination with ibrutinib in relapsed/refractory Chronic     Lymphocytic Leukemia (CLL) patients who have been pre-treated with at least one prior line of     systemic therapy, and who are eligible for treatment with ibrutinib. Objectives of the trial     are to determine the recommended Phase 2 dose of BI 836826, to investigate the number of     patients with a complete response and to document the safety and tolerability of BI 836826     when given in combination with ibrutinib   "
40321|NCT02757846|"     We propose a radiomics approach to identify prognostic biomarkers of HCC and provide patients     with some reasonable advice for their therapies.   "
40206|NCT02759341|"     The Tako-Tsubo Cardiomyopathy (TTC) and the Cardiac Syndrome X (CSX) are respectively acute     and chronic heart diseases, which mimic myocardial infarction and stable angina pectoris     without alterations of large coronary vessels. The causes and the most appropriate and best     treatment for these diseases have not been yet clarified, but there are indications, that     mental and psychosocial aspects may also contribute to these two diseases. So far, there is     no study, which has comprehensively evaluated the interactions between mind and heart in     these two conditions.      The purpose of this study is to search for possible differences in mental activity, response     to stressful events and function of specific areas of the brain deeply involved in relation     between mind and heart.      45 subjects will be recruited and divided equally into: patients with CSX, patients with TTC     (at least 6 months ago) and patients with previous acute myocardial infarction (at least 6     months ago). All participants will undergo a clinical interview and several questionnaires     that assess various mental functions, the stress response and the quality of life. In     addition, in a separate visit the participants will undergo a Magnetic Resonance Imaging     without contrast medium that helps to assess function of specific areas of the brain.   "
40207|NCT02759328|"     Commercial interactive game consoles including the Nintendo Wii™ and the Sony Playstation     Eyetoy™ have been used in stroke rehabilitation with variable success and seemed to be safe,     feasible and effective treatment options. The more recently released Xbox Kinect™ game     console has superiorities to the others such as not requiring any special controller and     having a more sensitive sensor which provides more accurate motion-capturing. However, there     is limited evidence on clinical utility of the Xbox Kinect™ in stroke rehabilitation.     Currently it has been designed for physically and mentally healthy people just like previous     consoles. Therefore, the safety and feasibility of the system should be evaluated in first     place before using it as an alternative or adjunctive training method in stroke patients. To     the best of our knowledge, no studies have evaluated the clinical feasibility of the Xbox     Kinect™ in stroke rehabilitation. The aim of this pilot study was to evaluate the feasibility     and safety of the Xbox Kinect™ training of upper extremity in subacute stroke rehabilitation.     The secondary aim was to evaluate its efficacy on upper extremity motor and functional     recovery.   "
40208|NCT02759315|"     The study is a single-center, multiple-arm investigation of co-administration of Uprifosbuvir     (MK-3682) 450 mg and Ruzasvir (MK-8408) 60 mg in participants with chronic Hepatitis C Virus     (HCV) Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6. The impact of the study treatment regimen     on Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks     after ending study treatment) for each HCV Genotype will be evaluated in cirrhotic     participants and non-cirrhotic participants.   "
40209|NCT02759302|"     POMT2 mutation is known to cause Walker Warburg Syndrome and Muscle-Brain-Eye syndrome.     Recently it has been connected to limb girdle muscular dystrophy (LGMD), a disorder     characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and     pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into     more than 31 different types. LGMD with POMT2 mutations is a new phenotype - type 2N. Very     few patients with the LGMD2N phenotype has been reported. In this study, the investigators     examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle     involvement using MRI.   "
40212|NCT02759263|"     Executive dysfunction can profoundly impact all dimensions of a child's development.     Impairments in executive function are a central component of the neurodevelopmental phenotype     associated with CHD, and manifest as behavioral dysregulation and problems with attention,     working memory, and organization/planning abilities. Identifying effective treatment     strategies is vital for providing optimal care for these patients. The Cogmed executive     function intervention, an evidence-based computerized neurocognitive program, improves     outcomes in several pediatric populations. The investigators propose to conduct a pilot study     to evaluate its efficacy in reducing morbidities in patients with CHD. This is a single     center, single blinded 2-arm randomized controlled trial to test the immediate post-treatment     and 3-month follow-up efficacy of Cogmed intervention versus standard of care in adolescents     with CHD.   "
40213|NCT02759250|"     To characterize the safety profile of ARGX-110 administered as mono- or combination therapy     to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).   "
40214|NCT02759237|"     The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been     demonstrated to be safe and effective for high through extreme risk patients with symptomatic     severe native aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic     valve failure. Per DCGI systematic post marketing surveillance requirement, the purpose of     this PMS plan is to provide local post marketing surveillance data regarding the safety of     Medtronic CoreValve System Family   "
40215|NCT02759224|"     An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics     of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual     Tablets in Healthy Adult Volunteers   "
40216|NCT02759211|"     There have been no published studies to date on the effects of backwards walking in persons     with MS. Thus it is important that the investigators explore different methods for treatment     to help improve balance and gait and prevent injury in persons with MS with gait disturbances     and balance impairments.The overall goal of this research is to collect pilot data on the     effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait     and balance assessments in persons with Multiple Sclerosis compared to forward walking.   "
40217|NCT02759198|"     The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in     patients with knee osteoarthritis.   "
40232|NCT02759003|"     In patients with amyotrophic lateral sclerosis (ALS), non-invasive mechanical ventilation     (NIV) is usually initiated in an in-hospital regime. The investigators evaluated if NIV     initiated in an outpatient setting can be as effective as regards patients' adherence. The     investigators also evaluated factors predicting NIV adherence and disease progression.   "
40233|NCT02758990|"     The purpose of this study is to study interactions between genes, lifestyle environmental     factors like foods, nutritional supplements and non-invasive medical devices and health     factors that can be measured without specialized medical equipment in order to develop     lifestyle recommendations tailored to individual genetics for a host of common chronic health     conditions.   "
40218|NCT02759185|"     Posttraumatic stress disorder (PTSD) is a debilitating disorder experienced by a subset of     individuals following life-threatening trauma, such as sexual and physical assault, natural     disasters, and military combat. Despite there being a number of treatments for PTSD, there is     a need to help people who have treatment-resistant PTSD and do not benefit from these     treatments as many individuals continue to experience marked PTSD symptoms following     treatment. In response to overwhelming demand, several U.S. states have passed laws allowing     the medical use of cannabis (marijuana) by individuals with PTSD. Unfortunately, there has     been very little scientific evidence on suitability of cannabis as an alternative therapy for     PTSD. The purpose of this study is to find out if cannabis can reduce PTSD symptoms in 76     military veterans with treatment-resistant PTSD. Four different types of smoked cannabis will     be evaluated using a triple-blind cross-over placebo controlled design. Study participation     will last 8.5 months. Participants will select a community observer, a friend or relative who     can be contacted by the researchers, who will report on the participant's health and     well-being throughout the study. After screening and meeting study requirements, participants     will be randomly assigned to receive one of four types of cannabis that vary based on THC and     CBD content. During the study, each participant will smoke two of the four types of cannabis,     up to 1.8 grams per day, for a 3-week period. Participants can smoke their daily 1.8g     cannabis at any time, using as much as they need. After each 3-week cannabis use period, they     will stop smoking marijuana/cannabis for two weeks where no cannabis use will be allowed.     Study findings will help researchers better understand the risks and benefits associated with     cannabis use among veterans with PTSD, information that can be used to aid in shared     decision-making among people with PTSD and their doctors or therapists.   "
40219|NCT02759172|"     The four year SPIRIT Trial, or Suicide Prevention Intervention for at-Risk Individuals in     Transition, will recruit 800 pretrial jail detainees at risk for suicide. Each participant     will be randomly assigned to today's standard care or to Safety Planning Intervention (SPI)     method and then followed for one year after release. Outcomes include suicide events, suicide     attempts and ideation, psychiatric symptoms, functioning, treatment utilization,     problem-solving, belongingness, and cost-effectiveness.   "
40220|NCT02759159|"     Alzheimer's disease (AD) is one of the major brain diseases which received more attention in     recent years. The disconnection syndrome is the main pathophysiological mechanism leading to     cognitive decline in AD patients. Both animal experiment and clinical observation have     demonstrated that acupuncture can generate treatment effect on AD patients by moderating the     neural pathway directly. However, the underlying mechanism remains unclear. By using resting     state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and     neurology sciences, investigators will explore the multi-modality data analysis; compare     brain connectivity and network parameters changes between pre- and post- acupuncture     treatment; analyze the correlation between fMRI changes and neuropsychology test. The present     study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide     theoretical evidence from the perspective of functional connectivity.   "
40221|NCT02759146|"     In order to optimize symptom management, there must be a shift from fixed interventions one     size fits all to adaptive interventions tailored to individual patients. Our multistaged     interventions use the sequential multiple assignment randomized trial (SMART) design. This     design will operationalize the decision rules for switching from one intervention to another     for individual patients. Our team's work to date with breast and lung cancer patients has     shown efficacy for two home-based symptom management interventions, reflexology and     meditative practices, delivered by or with friend or family caregivers. The sustainability of     use of these two evidence based therapies and improvements in symptom outcomes will be tested     during weeks 5-8 and at the week 12 follow up of 331 patients based on power analysis,     against a control group. By sequencing two evidence based interventions, the proposed     research will impact research and practice by determining how to maximize the benefit of     symptom management during cancer treatment.   "
40222|NCT02759133|"     This is a monocentric, non-inferiority, randomized cohort study with an open 1:1 ratio     comparing the impact of iodine seed tumor localization (arm B) vs. standard localization     using a metal guide (arm A) on the quality of the surgical resection margins in parallel     groups with an interim analysis in patients with breast cancer.      Randomization will be performed using histologic status stratification: in situ ductal     /invasive lobular +/- an in situ component / invasive ductal +/- an in situ component.   "
40224|NCT02759107|"     The main purposes of this study are to determine:        -  The safety of LY3298176 and any side effects that might be associated with it.        -  How much LY3298176 gets into the bloodstream and how long it takes the body to get rid          of it.        -  How LY3298176 affects the levels of blood sugar.      This study includes 3 parts (A, B and C). Part A involves a single dose of LY3298176 taken as     a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in     duration, including screening. Parts B and C involve 4 doses of LY3298176 taken once weekly     (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in     duration, including screening. Each participant will enroll in only one part.      This study is for research purposes only, and is not intended to treat any medical condition.   "
40225|NCT02759094|"     Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety     and effectiveness of RefluxStop for the treatment of GERD.      The used medical device RefluxStop is an implantable single use sterile device to ensure     maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or     eliminate GERD.   "
40226|NCT02759081|"     This prospective, randomize, controlled trial will compared cap-assisted water exchange with     water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis     that that cap-assisted water exchange is more efficient and causes a shorter insertion time.   "
40227|NCT02759068|"     Preferred music improves cognitive function in patients with disorders of consciousness     (DOC). However, it is still unknown whether it is a general effect of music (because of its     acoustic features) or an autobiographical effect (because of its emotional and meaningful     contents).      The aim of the present study was to investigate the effect of sensory modality (auditory     versus olfactory) and preference (preferred versus neutral) of the testing context on the     performance of four items from the coma recovery scale-revised   "
40252|NCT02758743|"     The purpose of this study is to validate the novel hypothesis that regular use of Acetium     Lozenge is promising novel method to assist in smoking cessation.      The aim of this confirmatory study is to affirm the promising results obtained in a previous     smoking intervention trial with Acetium lozenge. If successful, the trial gives adequate     power to confirm, that the Acetium lozenge represents a breakthrough in the development of     smoking intervention methods.   "
40234|NCT02758977|"     Surgical resection has offered the best option for prolonged survival in patients with     colorectal liver metastases. Limiting factor for major liver resections is the size of the     future liver remnant (FLR). In case of normal liver function, 30% of the total liver volume     is considered to be sufficient to maintain adequate liver function after resection. In an     attempt to further increase resectability criteria for patients with too small FLR surgical     and interventional maneuvers such as portal vein embolization and portal vein ligation in     two-stage hepatectomies have been implemented, but they need an interval of 4-8 weeks to     achieve sufficient hypertrophy. In order to obtain adequate but rapid parenchymal hypertrophy     a new surgical two-step technique, ALPPS, was introduced for oncological patients requiring     extended hepatic resection with limited functional reserve. Both procedures can be performed     with acceptable morbidity and mortality.      The investigators conclude that it is time to perform a randomized study comparing the two     surgical approaches in regard to oncological outcome.   "
40235|NCT02758964|"     EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of     cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after     TAVR.   "
40236|NCT02758951|"     Patients with potentially resectable peritoneal metastases arising from colorectal cancer are     randomised to (1) cytoreductive surgery with HIPEC and perioperative systemic therapy versus     (2) cytoreductive surgery with HIPEC without perioperative systemic therapy.   "
40292|NCT02758223|"     PACT is a non-randomized multicentre phase I/II study to evaluate the feasibility and safety     of the prophylactic administration of donor derived TCM. Patients with Acute Myeloid Leukemia     (AML) or Myelodysplastic Syndrome (MDS) who are planned to undergo a HLA -matched (9/10 or     10/10) allogeneic hematopoietic stem cell transplantation and who are either 50+ years old or     have a high comorbidity score are included according to criteria as described below. TCM will     be applied in escalating doses to a maximum of 30 patients who have received T cell depleted     Human leukocyte antigen (HLA)-matched alloHSCT grafts and qualify for TCM transfer.   "
40237|NCT02758938|"     The goal of this study is to test the usability of updated biofeedback game software     developed to help train the muscles involved in lower urinary tract dysfunction (LUTD)     through electromyography (EMG) controlled video games.      A Windows-DOS based biofeedback game system is currently used at the investigator's     institution to help treat LUTD in pediatric patients. This system, however, is outdated and     needs to be replaced with updated hardware and software. A new updated system was recently     created by University of Wisconsin-Madison (UW) Biomedical Engineering students. This system     utilizes a FDA approved EMG device (SRS Medical Aware™ EMG Dual Muscle Monitor) paired with     biofeedback game software that was developed by the students. The investigators wish to test     the usability of the new software to identify areas that need improvement to make the     software more user-friendly.      This study will evaluate the end users' (i.e., physician, biofeedback nurses, patients)     perception of the updated software. In determining usability, we hope to 1) decrease risk of     end user error; 2) make the software intuitive (easier to use); 3) decrease reliance on the     user manual; 4) decrease need for training; and 5) increase understanding of software     operation. This will be an ongoing study in which we continuously monitor the usability of     the software as it is updated based on end-user feedback. The investigators plan to do all     usability testing under the same IRB protocol. If further testing involves items not     discussed here, a new change will be made to the IRB application.   "
40238|NCT02758925|"     Forty percent of patients with diffuse large B cell lymphoma (DLBCL) have primary refractory     or relapsed disease (R/R). For these fit patients, standard treatment in second line therapy     is high dose therapy with autologous stem cell transplantation (ASCT). In 48% of DLBCL no     ASCT is possible due to progressive disease. For these patients or ineligible to     transplantation patients, salvage therapy is often rituximab-gemcitabine-oxaliplatine regimen     with an overall response rate (ORR) about 50%.      Bendamustine in combination with rituximab, used as a single agent in the setting of R/R     DLBCL patients, have shown an ORR of 62.7% and 45.8% with a good safety profile.      Bendamustine and cytarabine (BAC) showed high synergy in inducing cell death in mantle cell     lymphoma and DLBCL cell lines. In a recent phase II study, the combination of cytarabine with     Rituximab and Bendamustine (R-BAC) in patients with mantle cell lymphoma who were previously     untreated, refractory or relapsed was evaluated.      The efficacy and safety of the R-BAC association will be evaluated in this phase II trial     enrolling 78 patients with relapsed or refractory DLBCL.   "
40239|NCT02758912|"     The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic     parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers.      The study consists of four steps:        -  Step 1. Screening - selecting healthy volunteers for inclusion in the study;        -  Step 2. Assignment in one of the study group, prescription of the study drug;        -  Step 3. Samples collections for pharmacokinetic analysis;        -  Step 4. Evaluation of pharmacokinetic data.   "
40240|NCT02758899|"     The purpose of this study is to determine the relevant significance of diabetes on cervical     disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile in     patients undergoing anterior cervical discectomy and fusion for cervical spondylosis.     Additionally, to compare the level of degenerative cervical disc glycosylation in patients     with and without diabetes.      Hypothesis: Patients with diabetes and degenerative cervical disc disease have higher levels     of disc tissue glycosylation, and higher levels of glycosylation are correlated with poor     outcomes.   "
40241|NCT02758886|"     The purpose of this study is to determine whether an animal visitation programs on college     campuses are effective in the treatment of college student stress reduction during     preparation for final examinations.   "
40261|NCT02758626|"     This is a phase 2, crossover study of Ataluren for the treatment of nonsense mutation Dravet     syndrome or cyclin-dependent kinase-like 5 (CDKL5) deficiency, resulting in drug-resistant     epilepsy. Patients will receive 12 weeks of ataluren or placebo during each treatment period.     Treatment Period 1 will be followed by a 4-week Washout Period. Based on ataluren PK and     pharmacodynamic data, the 4-week washout period is deemed an appropriate length of time to     eliminate any ataluren drug effects. Following the Washout Period, patients will crossover to     receive the opposite treatment during Treatment Period 2 as follows: Patients receiving     ataluren during Treatment Period 1 will receive placebo during Treatment Period 2. Patients     receiving placebo during Treatment Period 1 will receive ataluren during Treatment Period 2.   "
40242|NCT02758873|"     One in every 11 children in the United Kingdom (UK) has asthma. Children with asthma cough,     wheeze and have difficulty breathing. The symptoms which children experience can mean they     miss school and makes it difficult for children to take part in playground games and sports.     Some have to be admitted to hospital. In fact, in the UK a child is admitted to hospital     every 18 minutes because of their asthma.      Effective medicines are available, but a child's response to these medicines is currently     unpredictable. This project focuses on an asthma controller medicine called salmeterol.     According to reports, tens of thousands of children may be taking this medicine in the UK,     but evidence suggests it might not work for around one in seven of them. The study team are     investigating whether a new approach to treatment, where prescribing is personalised     according to a child's genetic make-up, improves the child's quality of life and provides     better control of their asthma. Treatment that is tailored in this way to a person's genetic     features is often called 'personalised medicine'.      At the moment, doctors commonly prescribe salmeterol to relieve asthma symptoms if children     do not benefit enough from other medicines. But evidence suggests salmeterol may not work     properly in children with a certain genetic makeup.      The study team are investigating whether it helps to take children and young people's genetic     makeup into account when deciding whether to give them salmeterol or an alternative medicine     called montelukast. A simple and inexpensive saliva test can provide the information needed     to guide decision making.   "
40243|NCT02758860|"     The Diverticular Inflammation and Complication Assessment (DICA) is an endoscopic     classification for diverticulosis and diverticular disease of the colon.      The aim of the study is to show that DICA classification is a valid parameter to predict the     risk of acute diverticulitis occurrence/recurrence and the need of surgery in patients     suffering from diverticulosis/diverticular disease of the colon.   "
40244|NCT02758847|"     The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue     loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated     balloon angioplasty in the tibial arteries was terminated. The investigators objective is to     establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive     disease in patients with critical limb ischemia (CLI) and tissue loss.      The investigators objective is to establish the safety and efficacy of drug coated balloon     (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and     tissue loss.   "
40245|NCT02758834|"     The purpose of this study is to determine plasma phytosterols half-lives in preterm infants     who received intravenous soy oil-based lipid emulsions.   "
40246|NCT02758821|"     PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC)     testing on health care worker prescribing behaviour in patients presenting to primary     healthcare centres with an acute fever or recent history of fever.      SECONDARY OBJECTIVES To assess the impact of CRP testing on clinical outcomes within the 14     days of follow-up.      To assess the correlation between CRP results and clinical outcomes on the day 5 of the     enrolment.      To estimate the impact of CRP testing on antibiotic consumption after first consultation.      To explore the attitudes of health centre staff towards the POC CRP test. To identify the     prevalence of key pathogens in febrile patients in these settings.      To validate the ability of CRP to discriminate between viral and bacterial pathogens in a     subset of patients with a microbiologically confirmed diagnosis.   "
40247|NCT02758808|"     The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000     patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US.     The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to     have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of     well-characterized patients with interstitial lung disease (ILD) for participation in     retrospective and prospective research   "
40248|NCT02758795|"     The aim is to evaluate the effect of ingestion of a modified bovine milk protein on     circulating markers of inflammation in healthy men and women aged 50-70y.The focus is healthy     ageing, i.e. delaying the deterioration in health status in older adults. Loss of lean tissue     mass, termed sarcopenia is a consequence of aging per se, modified by nutrition and lifestyle     behaviour. Advancing the prospect of 'successful aging' a 6-month period of protein-based     nutritional support has shown preservation/accrual of lean tissue. Chronic low-grade     inflammation is common in ageing and is a compounding factor leading to 'anabolic blunting',     i.e. a reduced sensitivity of lean tissue to enhance the synthesis of lean tissue mass in     response to protein feeding. Using a simulated human gastrointestinal digestion model we have     recently shown proteins to have an anti-inflammatory bioactivity in vitro. This study     investigates whether the anti-inflammatory response is retained, post-digestion in vivo.   "
40249|NCT02758782|"     To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) -     Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as compared     to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over     two years in patients with ankylosing spondylitis (AS).   "
40250|NCT02758769|"     Examine the effectiveness and safety of the abatacept administration in biologic-naïve     rheumatoid arthritis patients who have moderate disease activity despite treatments with     conventional synthetic disease modified anti-rheumatic drugs.   "
40251|NCT02758756|"     The proposed study will assess whether either massage or an Integrative Medicine practice     called Reiki can alleviate fatigue in subjects receiving hormonal treatments. Reiki is     classified by the National Center for Complementary and Integrative Health as a     biofield/touch therapy, and Reiki practitioners believe that their gentle therapy promotes     healing and well-being by unblocking and balancing energy flow and re-establishing     homeostasis within the human energy field. The study is a three-arm randomized clinical trial     in 99 breast and prostate cancer patients who are undergoing hormonal therapy (i.e., androgen     deprivation therapy (ADT) for males or an aromatase inhibitor (AI) for females) and currently     experiencing fatigue. Subjects will be studied during ten weeks of hormonal therapy with two     weeks of baseline assessments followed by a four-week intervention, and a four-week     post-intervention period. Arm 1: Subjects will receive two Swedish-style massages. Arm 2:     Lower-dose Reiki intervention - Subjects will receive two Reiki treatments. Arm 3:     Higher-dose Reiki intervention - Subjects will receive four Reiki treatments.   "
40253|NCT02758730|"     This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase     I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of     AFFITOPE® PD01A, adsorbed to aluminium oxide in 30 patients with PD-GBA over a treatment     period of 8 weeks. Patients will be randomized in a 2:1 ratio to two different treatment     groups: A) 75 µg AFFITOPE® PD01A, adsorbed to aluminium oxide and B) placebo (= 1 mg     aluminium oxide).      Over a study duration of 52 weeks, each patient will receive 3 injections of AFFITOPE® PD01A     or placebo during the participation in the clinical trial. Patients will either receive 75 µg     AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide or placebo (=1mg aluminium oxide). The     treatment group consists of 20 PDGBA patients, the placebo group of 10 PDGBA patients. Male     and female patients aged 40 to 80 years can participate in the trial.      AFF010 is part of the project MULTISYN funded by the European Commission     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602646).   "
40254|NCT02758717|"     This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older     patients with untreated Hodgkin lymphoma. Monoclonal antibodies, such as nivolumab, may block     cancer growth in different ways by targeting certain cells. Biological therapies, such as     brentuximab vedotin, use substances made from living organisms that may stimulate or suppress     the immune system in different ways and stop cancer cells from growing. Nivolumab and     brentuximab vedotin may work better in treating older patients with untreated Hodgkin     lymphoma.   "
40255|NCT02758704|"     This study will be a randomized controlled trial designed to analyse the impact of stress on     the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric     residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS)     environment where they will be asked to perform a standard neonatal intubation procedure.     Subjects will then cross-over to the second scenario within a short window (1-2 weeks).     Outcome measures include: endotracheal intubation success rate and assessment of the     procedure performance by video-review using a standardized checklist rated by two independent     reviewers. Stress level will be measured using salivary cortisol, heart rate and a     standardized anxiety questionnaire.   "
40256|NCT02758691|"     Recent research has suggested insulin may be involved in how human's form and recall     memories. This study is designed to look at how nasal insulin is used in the brain.     Specifically, how insulin alters the various connections within brain regions that occur     while adults perform simple attention and memory tasks. This study is divided into two parts:     blood draw procedure and fMRI (functional Magnetic Resonance Imaging) procedure. The blood     draw procedure is designed to look at the effects of intranasal insulin using a Precision     Olfactory Delivery (POD) device on the blood levels of glucose and insulin. Those asked to     participate will receiving a low-dose saline solution and low-dose of insulin through a nasal     spray followed by a blood draw session to measure your blood glucose and insulin levels over     a 90 minute period.      Participation in the fMRI (functional Magnetic Resonance Imaging) procedure will involve     receiving a low-dose of insulin or a saline solution through a nasal spray using a Precision     Olfactory Delivery (POD) device and brain scan using Magnetic Resonance Imaging (MRI). During     the scan, participants will complete a series of memory tasks reflected on a computer screen.     The trial will be randomized and double-blinded.   "
40257|NCT02758678|"     Purpose:      Selectins are vascular cell adhesion molecules involved in adhesive interactions of     leukocytes and platelets and endothelium within the blood circulation.      Plasma soluble P selectin (sP-selectin), is a one of member of selectin family, an adhesion     molecule and component of the membrane of the platelet alpha granulate has been proposed as a     one marker of platelet activation. In this study we evaluate of expression of P selectin on     platelets of blood between serum samples from lung cancer and healthy individuals.   "
40258|NCT02758665|"     A prospective, open-label, multicentre phase-II trial of ibrutinib plus venetoclax plus     obinutuzumab in physically fit (CIRS ≤ 6 & normal creatinine clearance) and unfit (CIRS > 6 &     creatinine clearance ≥ 50 ml/min) patients with previously untreated chronic lymphocytic     leukemia (CLL) with TP53 deletion (17p-) and/or mutation   "
40259|NCT02758652|"     Epithelial ovarian cancer is the most lethal gynecological malignancy in developed countries     and the fifth most common cause of cancer-related death in women. Poor prognosis is due to     challenges in early diagnosis and development of inevitable resistance to chemotherapy in     majority of patients despite of good initial treatment response. The purpose of this     prospective study is to analyze variation in microRNA expression in prediction of primary     treatment response and the role of microRNAs in development of chemoresistance in epithelial     ovarian cancer.      • Objectives: To screen microRNAs from prospectively collected plasma, urine and tumor     samples from patients diagnosed with epithelial ovarian cancer. Samples are analyzed for     microRNA expression and differential expression is correlated with primary treatment     response, progression-free survival and overall survival.      • Methods: Plasma, urine and tumor samples are collected at primary surgery (open surgery or     diagnostic laparoscopy) or interval debulking surgery, at 1st, 3rd and 6th neoadjuvant or     adjuvant chemotherapy and at progression for high-throughput screening of microRNA expression     by array technology.   "
40260|NCT02758639|"     Parental cancer can cause substantial behavioral and emotional distress in both parent and     child. Parents struggle with talking with their child about their cancer and supporting the     child during treatment. Over 73% of patients with children desire information and services to     support their children yet only 9% of these families report receiving this support. The     purpose of this study is to evaluate the Wonders & Worries psychosocial intervention designed     for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a     randomized controlled clinical trial (RCT) evaluating the Wonders & Worries group and     individual intervention for school age children (5 -14 years old) who have a parent with     cancer. Families will be enrolled at the time of initial parent consultation, given informed     consent, and then randomized either to the intervention group of 30 families or the     wait-listed control group of 30 families. Both groups will be given a series of standardized     validated assessment instruments including the Revised Children's Manifest Anxiety Scale     (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at     baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures,     families in the wait-listed control group will be enrolled into the intervention. Parent exit     interviews for both groups will be used to measure parent-reported child outcomes and program     utility.   "
40262|NCT02758613|"     The main purpose of this study is to investigate the safety and tolerability of the study     drug known as LY3009104 in healthy Chinese participants. The study will measure how the body     absorbs, breaks down and gets rid of LY3009104. The study will last about 20 days, not     including screening. This study is for research purposes only, and is not intended to treat     any medical condition.   "
40276|NCT02758431|"     This study plans to learn more about heart and vascular aging in men. In some men as they get     older, testosterone levels fall below the normal range for young men. Also, as men get older     cardiovascular health worsens. This can lead to high blood pressure and heart disease. In     this study we want to find out what causes cardiovascular health to worsen in older men. Also     we want to find out what happens when testosterone levels are lowered for a short time.     Specifically, we want to see if the reduction in cardiovascular health in older men with low     testosterone levels is because of damage to mitochondria. Mitochondria are the main power     supply of the cells in our body. The results from this study will help to understand why     cardiovascular health declines in older men with low testosterone levels compared to younger     men and older men who have higher testosterone levels. Knowing this information will help to     develop therapies to prevent heart disease in men.   "
40263|NCT02758600|"     Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and     greater quality of life in patients with coronary arterial disease. Evidences on the     cardiovascular and gas-exchanges responses during and right after early exercise-based     rehabilitation of this patients are limited. Objective: The investigators aim to analyse     breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6MWT)     and shuttle walk test (SWT) in patients with or without left ventricular dysfunction (LVD)     after CABG. In addition, the investigators will investigate oxygen consumption and     cardiopulmonary responses during the early exercise-based rehabilitation in the first days     after surgery. Methods: According to the left ventricular ejection fraction (LVEF), subjects     will be allocated into two groups: with LVD (LVEF < 45%) and without LVD (LVEF > 45%).     Patients will be submitted to the 6MWT and SWT linked to portable spirometric-telemetric     device before and 6 days after CABG. During the first days after surgery, patients will be     evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption     during the portable cycle ergometer protocol. Clinical outcomes as time to hospital     discharge, pulmonary complications and occurence of arrythmias will be assessed during     inpatient time until hospital discharge. Incidence of mortality, hospital readmission and     angina recurrence will be evaluated in a one-year follow up.   "
40264|NCT02758587|"     This study will explore whether defactinib (a FAK inhibitor) can be safely and tolerably     combined with pembrolizumab (a PD-1 inhibitor) and will look for early indications of     improved anticancer immunotherapy. It will focus on three key cancers, all in clear need of     improved therapies - NSCLC, pancreatic cancer and mesothelioma.   "
40265|NCT02758574|"     The study will compare standard catheter directed thrombolysis to ultrasound accelerated     thrombolysis for the treatment of acute submassive pulmonary embolism (PE). The study     population will include patients eligible for catheter directed thrombolysis (CDT) for     submassive PE. Subjects will be randomized to, either, standard catheter-directed     thrombolysis or ultrasound-accelerated thrombolysis (USAT).   "
40266|NCT02758561|"     This pilot study will assess the feasibility and acceptability of an educational workshop on     pelvic floor disorders and its potential impact on decisional conflict.   "
40267|NCT02758548|"     The purpose of this study is to determine the accuracy of the Novel point of care test (POCT)     total IgE assay in atopic patients.      120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled.     Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous     samples will be collected and sent to a reference laboratory for measurement of serum total     IgE using the reference immunoassay method.   "
40268|NCT02758535|"     Percutaneous image-guided parenchymal renal biopsy has been used to detect the different     pathologies of renal parenchyma, to define the degree of reversible changes, and to define     when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to     have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle     renal biopsy is usually based on tissue sampling under guidance of either sonography or     computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial     technique. In coaxial technique, the introducing needle is placed in the renal parenchyma;     then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in     noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although     there are some reports regarding the comparison of coaxial and noncoaxial methods of renal     mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been     described in the literature. In this prospective study, the investigators sought to compare     the procedural time and the complication rate of coaxial technique with those of noncoaxial     technique in percutaneous renal parenchymal biopsy.   "
40269|NCT02758522|"     The objective of this study is to compare the therapeutic efficacy of three regimens of     insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.   "
40270|NCT02758509|"     Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral     treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with     ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially     in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in     genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy     but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve     great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of     DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to     evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies     (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European     guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained     virological response on gastroesophageal varices (GOV).   "
40271|NCT02758496|"     The purpose of this study is to evaluate the safety and efficacy of Magnetic EEG/ECG-Guided     Resonance Therapy (MeRT) on subjects with Autism Spectrum Disorder (ASD).   "
40272|NCT02758483|"     BACKGROUND: The treatment with continuous glucose monitoring system (CGMS) offers improved     glycemic control for patients with type 1 diabetes. However, patients with type 1 diabetes     usually intake foods with sugar, even without hypoglycemic episodes, and the use of advanced     carbohydrate counting method may increase the calories and carbohydrate intake.      OBJECTIVE: To evaluate and compare the influence of sucrose-free diet or sucrose-added diet     on glucose variability in patients with type 1 diabetes.      METHODS: The study was a simple-blind, two-way crossover design in which patients with type 1     diabetes will receive a control diet (a diet with a little quantity of sugars) or test diet     (with foods containing moderate quantity of sucrose in composition) during two-days each.     During the intervention, all foods and drinks intake will have to be documented to allow     quantitative estimation of dietary intake, to verify adherence to the diets. After one-week,     each patient will return for download CGMS.      PURPOSE: The research proposal adds knowledge about the glucose variability in patients with     type 1 diabetes who use foods with sugar in theirs habitual dietary intake.   "
40273|NCT02758470|"     The objective of this research is to assess the effects of acetazolamide and methazolamide on     respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted for     the respiratory and plantar flexor muscles and the difference in pressure/torque produced by     supramaximal nerve stimulation used to assess muscle fatigue between conditions.   "
40277|NCT02758418|"     The purpose of this study is to determine the differential efficacy and effectiveness of a     self-help treatment for adjustment disorders administered in two different formats: 1)     computerized program applied over the Internet and 2) traditional bibliotherapy sent by     e-mail. In addition, both treatment modalities included in the study will be compared with a     waiting list control group.      It is expected that, on the one side, both intervention groups will improve significantly     compared to the waiting list control group, and the computerized program applied over the     Internet will be more effective than the treatment through traditional bibliotherapy sent by     e-mail. On the other side, it is expected the self-applied online treatment program to have     less drop-outs and be better accepted and valued by the patients than the bibliotherapy     condition.   "
40278|NCT02758405|"     Brief Summary:      Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with     a pump that could only provide continuous infusion of the freezing medication in combination     of pushes of medication activated by the patient, a technique called patient controlled     epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this     continuous infusion of medication is not as effective as previously thought, and suggested     that instead of continuous infusion, intermittent programmed pushes should be used. The     investigators now have devices that are able to do that. Programmed intermittent epidural     bolus (PIEB) is a new technological advance based on the concept that boluses of freezing     medication in the epidural space are superior to continuous epidural infusion (CEI). The     investigators are currently using pumps set up with PIEB, in addition to what the patient can     deliver herself (PCEA). Studies have shown that delivering analgesia in this manner prolong     the duration of analgesia, reduce motor block, lower the incidence of breakthrough pain,     improve maternal satisfaction and decrease local anesthetic consumption. The investigators     have recently concluded a study at MSH using PIEB where they observed excellent results.     However, some patients exhibited higher than necessary sensory blocks. The investigators     believe that the technique can be optimized by using the same dose of the freezing     medication, but using a smaller volume of local anesthetic at a higher concentration. This     optimization may also further reduce the amount of medication used by each patient.      The hypothesis of this study is that there is an optimal interval time between PIEB boluses     of 30 to 60 minutes at a fixed volume of 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml     that will provide women the necessary drug requirements, thus avoiding breakthrough pain and     need for PCEA or physician intervention.   "
40279|NCT02758392|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and     immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose     administration and a single Subcutaneous (SC) dose administration in healthy participants.   "
40280|NCT02758379|"     The objective of this clinical trial is to study the early safety and feasibility of the     Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely     and effectively deliver localized shockwave energy for balloon dilatation of calcified,     stenotic, de novo coronary lesions.   "
40281|NCT02758366|"     The standard therapy of glioblastoma (GBM) consists of gross total resection followed by     focal irradiation to the tumor bed with concomitant and adjuvant temozolomide (TMZ). The     association of valproic acid and TMZ during radiotherapy improves survival of GBM.     Preclinical studies suggested that doxorubicin had a strong antineoplastic activity against     human gliomas. Moreover, some studies showed that the continuous infusion of anthracyclines     in patients with solid tumor ensured a better safety profile compared with bolus     administration.      Based on these findings, the purpose of this study is to evaluate safety and efficacy of     prolonged administration of doxorubicin in combination with radiotherapy, temozolomide and     valproic acid in pediatric and adult patients with newly diagnosed GBM and diffuse intrinsic     pontine glioma (DIPG).   "
40282|NCT02758353|"     The purpose of this study is to test the feasibility of the scale-up of sulphadoxine-     pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local     Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the     introduction of community-based distribution of SP in addition to ongoing health facility     distribution during antenatal care (ANC) visits. In addition, the study examined for the     effect of SP use by participants during pregnancy on the head circumference of live newborns     and on the odds of a baby being a stillborn. Finally, the investigators also sought to     quantify the costs associated with program scale up SP to deliver at least three doses of SP     per participant via a government operated distribution program.   "
40283|NCT02758340|"     The study will compare the number of women who deliver vaginally after artificial initiation     of labor pains(i.e. induction of labor) by two methods. Half of the women would receive     tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's     balloon catheter both.   "
40284|NCT02758327|"     The objective of the study is to demonstrate a change in osmolarity over time when moderate     to severe dry eye subjects are treated with TheraTears lubricating drops.   "
40285|NCT02758314|"     Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating     T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1     (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer     patients, particularly in those with lung cancer, has not been sufficiently studied. The     purpose of this study is evaluate the expression of PD1 and PDL1 in subpopulations of     peripheral blood and tumor cells patients with lung cancer non-small cell (NSCLC),     associating with clinicopathological features of the patients studied.   "
40287|NCT02758288|"     The investigator's aim in this study is to evaluate the impact of a new standard of care     protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching     from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with     BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular     filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.   "
40288|NCT02758275|"     The purpose of this study is to improve the adherence of therapeutic regimen in people with     hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing     intervention Teaching: Individual, is more effective to increase adherence of therapeutic     regimen in people with hypertension arterial and/or diabetes mellitus type 2, than usual     care.   "
40289|NCT02758262|"     The goal of this project is to identify brain mechanisms by which Noninvasive brain     stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver     NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind     study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to new     therapeutic avenues to treat this eating disorder.   "
40297|NCT02758158|"     Thyroid cancer affects 6,000 Canadians each year. Nodules on the thyroid are detected using     ultrasound imaging and surgery is the most common treatment. However, most nodules are     benign, and therefore a biopsy is needed to decide whether surgery is necessary. Ultrasound     imaging is very sensitive for localizing nodules, but does not differentiate between     cancerous and benign ones. To address this limitation of US imaging, investigators have     designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel     imaging system that performs complimentary imaging modalities (ultrasound (US), photoacoustic     (PA)) that could potentially help diagnose nodules without the need for biopsy and     unnecessary surgery.   "
40298|NCT02758145|"     The investigators will compare two groups, an intervention group with a control group. Each     employee of the University Hospital of Lausanne (CHUV) and the University Medical Policlinic     of Lausanne (PMU) who will do his recruitment visit at the occupational medicine unit of the     CHUV between 04/25/16 (end of previous influenza epidemic) and 31/10/16 (the day before the     start of the next influenza vaccination campaign) and exert a function in regular contact     with patients will be eligible. Depending on his employee number (assigned by the human     resources administration, independent of any parameter), he will be placed in the     intervention group G1 (odd number) or in the control group G2 (even number). The information     concerning the distribution of these two groups will be noted in the computerized medical     records of the employee at the occupational medicine unit (Medipho4D software, secured     database). Thereafter, the employee will be received by the nurse of the he occupational     medicine unit for a recruitment visit according to the usual process. The nurse will perform     the study intervention in addition to the usual procedure if it is stipulated ''intervention     group'' on the employee's record in the database or only perform the usual steps if it is     stipulated ''control group''. At the beginning of the next influenza vaccination campaign     (mid-November 2016), employees in the intervention group will receive a letter reminding then     about the intervention given during the recruitment visit and inviting them to get     vaccinated. During the next influenza vaccination campaign (11.01.16) and until the end of     the influenza epidemic that will follow (April 2017), each employee will have the opportunity     to be vaccinated at the different vaccination stalls set up by the occupational medicine     unit. For each employee vaccinated, the date of vaccination and vaccine name is entered in     the electronic medical records of the occupational medicine unit (Medipho4D software) by a     nurse or a secretary of the unit. At the end of the human influenza epidemic (April 2017),     the data will be extracted from the database (Medipho4D software) and anonymized by an     individual not implicated in the study. Data from two groups will be analyzed and compared to     assess whether the intervention conducted among newly hired employees promotes influenza     vaccination.   "
40299|NCT02758132|"     This is a correlative study to characterize serum metabolites associated with bone     deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not     currently receiving bone targeting agents.   "
40300|NCT02758119|"     The objective of this study is to compare two forms of pre-training (an online narrative     presentation and a serious game) to prepare 2nd year medical students for a hands-on training     with physical simulators about out-of-hospital cardiac arrest management.   "
40301|NCT02758106|"     BACKGROUND: Endotracheal intubation and prolonged immobilization of patients receiving     mechanical ventilation may reduce expectoration function. High frequency chest wall     oscillation (HFCWO) may ameliorate airway secretion movement; however, the vigorous     oscillation may influence ventilator settings and change instantaneous cardiopulmonary     responses. The aim of this study was to investigate these issues. METHODS: Seventy-three     patients aged >20 years who were intubated with mechanical ventilation for pneumonic     respiratory failure were recruited and randomly classified into two groups (HFCWO group,     n=36; and control group who received conventional chest physical therapy (CCPT), n=37). HFCWO     was applied with a fixed protocol, while CCPT was conducted using standard protocols. Both     groups received sputum suction after the procedure. Changes in ventilator settings and the     subjects' responses were measured at pre-set intervals and compared within groups and between     groups.   "
40302|NCT02758093|"     As people age with HIV, the synergistic effects with normal age-related cognitive declines     will accentuate and/or accelerate declines in cognitive functioning which can be detected as     early in one's 40s. Although interventions are needed to protect/improve cognitive     functioning, one intervention already exists to improve speed of processing. NINR/NIA     (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N =     2,802 community-dwelling older adults) has the ability to enable older people to maintain     their cognitive abilities as they age even 10 years after training. As shown in the ACTIVE     Study, this intervention uniquely improves driving, instrumental activities of daily living     (IADL), health-related quality of life, self-rated health, internal locus of control, and     protects one from depression; these represent areas of needed intervention for adults with     HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing     declines are associated with poorer driving simulator performance and more self-reported     at-fault automobile crashes; such speed of processing declines on driving alone represent a     significant public health concern. These studies also demonstrated that Speed of Processing     Training improved this cognitive ability and translated into improved performance on a timed     measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year     longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with     HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training     conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of     laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized     computer-contact control (sham) condition.      AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this     cognitive ability at post-test, year 1, and year 2 after baseline.      AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday     functioning at post-test, year 1, and year 2 after baseline.      Exploratory AIM: Determine whether improvement in speed in speed of processing and/or     everyday functioning over time mediate improvement quality of life (e.g., depression, health     related quality of life).   "
40303|NCT02758080|"     A molecular profile of a patient with hematologic malignancy, for whom standard-of-care had     failed, is identified using next generation sequencing. Patients are assigned to early     clinical trials of targeted agent based on the molecular profiling or physician's choice. The     improvement of outcomes in the intention-to-treat population is investigated.   "
40304|NCT02758067|"     To demonstrate that the effectiveness of brexpiprazole (2-4 mg/day) on quality of life is     non-inferior to that of risperidone (4-6 mg/day) in adult patients with schizophrenia.   "
40305|NCT02758054|"     The study proposes to evaluate a patient navigation intervention among a sample of 340     individuals referred for CT-based lung cancer screening in an urban safety-net setting.   "
40306|NCT02758041|"     This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial     inflammatory acne vulgaris.   "
40308|NCT02758015|"     Food will decrease stomach acidity due to its buffering effect.This has implications when     providing drugs that are dosed with food but require higher levels of stomach acid, such as     some medications commonly used for HIV patients. This study will attempt to determine the     dose of betaine hydrochloride (over the counter acid supplement) at which the effect of food     on stomach acid could be countered. Additionally, this study will evaluate the ability of a     natural supplement (betaine hydrochloride) to affect the gastric pH following a standardized     meal in healthy volunteers. The investigators predict that 4500mg of betaine hydrochloride     will have the greatest effect on gastric pH.   "
46917|NCT02671500|"     This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir     (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in treatment-naive     and treatment-experienced participants with chronic hepatitis C virus (HCV) infection.   "
40309|NCT02758002|"     There is growing awareness of the importance of electrical rotors to the maintenance of     atrial fibrillation (AF). Recent work in our laboratory has found that AF evolves over time,     from rapid, focal activation, next to transitional rotors, and finally to stable, long     duration rotors, whose locations are frequently separate from the transitional rotor sites.     This project will test the hypothesis that mapping and ablation of the transitional rotors     sites may prevent atrial fibrillation from progressing to sustained atrial fibrillation, and     therefore increase the AF initiation threshold. The investigators will test this hypothesis     during clinically-indicated electrophysiology study prior to ablation of symptomatic AF.   "
40310|NCT02757989|"     Comparison of survival in patients with or without a matched donor at 36 months   "
40311|NCT02757976|"     This trial will compare two strategies for patients with Heart Failure, Left Ventricular     systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT.     The experimental group is LVendo CRT   "
40312|NCT02757963|"     This non-randomized, interventional study will be conducted in a general practice setting to     assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO)     screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed     to have BPH on full urologist assessment of diagnostic test results. The tool may help a     General Practitioners (GP) to identify subjects who may have BPH for further tests and     improve the speed of referrals to specialists when this is appropriate. The utility of the     screening tool will be compared to the validated tool in wide clinical use, the International     Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the     primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary     tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of     this screening tool will be used for further investigation. All subjects testing positive on     the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and     offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1).     The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist     to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP     will make a diagnosis of probable BPH based upon screening results and lab tests which     suggest that they are related to BPH and not other causes of such symptoms. The GP will phone     the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has     probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject     does not have probable BPH, then it will be considered that the subject has completed the     study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment     performed by an urologist. This assessment includes a DRE and a brief physical exam and     review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of     progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to     this study will be screened for probable BPH to yield 500 subjects being referred to an     urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow     for GP and urologist visit scheduling.   "
40313|NCT02757950|"     The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered     during pregnancy in a maternal immunization program in Brazil.   "
40315|NCT02757924|"     To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on     symptoms of formula intolerance in healthy term infants.   "
40316|NCT02757911|"     X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects     boys. It is a primary immunodeficiency disorder which results from an inability of the white     blood cells called phagocytic cells (or phagocytes) to kill invading bacteria and fungi.     These cells have difficulty forming the free radicals (most importantly the superoxide     radical due to defective phagocyte NADPH oxidase complex) which are important in the killing     of ingested pathogens. In X-CGD (which accounts for two thirds of CGD patients), the defect     lies in a gene which makes up a critical part of the NADPH-oxidase complex (the catalytic     subunit; gp91-phox protein). Therefore they kill bacteria and fungi poorly, and the patients     suffer from severe and recurrent infections. This also results in inflammation which can     damage parts of the body such as the lung and gut.      In many cases, patients can be adequately protected from infection by constant intake of     antibiotics. However, in others, severe life-threatening infections break through. In some     cases, inflammation in the bowel or urinary systems results in blockages which cannot be     treated with antibiotics, and which may require the use of other drugs such as steroids.     Development of curative treatments for CGD is therefore of great importance.   "
40317|NCT02757898|"     The purpose of this research is to study how red blood cells (RBCs) survive in a person's     circulation, and how that survival may be different in red blood cells that are donated and     stored prior to being transfused. Investigators will study this by collecting blood samples     from participants, labeling RBCs with a naturally occurring vitamin, biotin. The RBCs will     then be re-infused back into the participant and blood samples will be taken weekly for 10     weeks to assess the number of labeled cells in the samples.   "
40318|NCT02757885|"     The purpose of this study is to learn if it is possible and safe to treat persons with severe     sickle cell disease (SCD) by bone marrow transplant (BMT) from human leukocyte antigen (HLA)     half-matched related donors. Preparation before transplant includes the chemotherapy drugs     hydroxyurea, fludarabine, thiotepa, anti-thymocyte globulin, and cyclophosphamide. It also     includes radiation.   "
40319|NCT02757872|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 US men and women investigating whether taking dietary supplements of vitamin D3     (2000 IU) or omega-3 fatty acids (Omacor (R) fish oil, 1 gram) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. The VITAL Kidney Function in Hypertension ancillary study will evaluate the     effects of vitamin D or omega-3 fatty acids on kidney function among participants with     baseline hypertension.   "
40320|NCT02757859|"     This randomized clinical trial studies how well high volume washing of the abdomen works in     increasing survival after surgery in patients with pancreatic cancer that can be removed by     surgery. High volume washings may remove free floating cancers present after surgery and help     prolong survival in patients with pancreatic cancer.   "
40519|NCT02755233|"     Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM     before and during treatment with ipilimumab are performed. A reduction from baseline of     forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus     indicative for pulmonary toxicity.   "
40322|NCT02757833|"     Female participants with an episode of late-life depression (LLD) and age-matched control     participants with no history of mental disorder will attend a one hour Magnetic Resonance     Imaging (MRI). A 3 Tesla MRI scanner will be used to measure levels of glutathione (GSH) in     the brain via magnetic resonance spectroscopy (1H MRS).   "
40323|NCT02757820|"     The aim of this randomized trial will be to evaluate the clinical performance of the I-gel,     air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery     under general anesthesia.   "
40324|NCT02757807|"     The aim of this study is to determine if patients with ED taking PDE5 inhibitors (e.g.     Viagra, CIalis, Levitra, Stendra) and experiencing performance anxiety will benefit using a     user-friendly stress reducing phone app, Serenita. The study is internet based with no office     visits.   "
40325|NCT02757794|"     Prematurity tends to increase in France in recent years and more children born extremely     premature infants survive. If severe impairments have stabilized, the majority of former     extremely premature children have neuropsychological disorders and moderate appearance     behavior disorder, but with a significant impact both family, school and social persisting     into adulthood.      Executive functions (EF), in general, and working memory (MT), in particular, are frequently     altered in older children preterm infants compared to controls born at term.      The identification process of loss in certain diseases, as well as improving knowledge of     brain functioning, and development with the possibility of neuronal plasticity has led     research teams to develop intervention programs focused on process cognitive qualified of     remediation cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered     cognitive functions. MT can be improved by encouraging the operation of the spots mental     stimulant. These programs are effective on MT but do not have the expected impact on other     FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive     remediation remains controversial.      Improving mental functions untrained as nonverbal MT, attention and secondarily learning is     possible but still unproven on wide population. Similarly, randomized trials are needed to     test this type of cognitive remediation among preschoolers old very premature.   "
40326|NCT02757781|"     The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual     in improving attitudes of primary care professionals on the empowerment of patients with     chronic diseases.   "
40327|NCT02757768|"     The purpose of the study is to assess the efficacy, safety, and tolerability of mirabegron     versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin     hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia     (BPH).   "
40328|NCT02757755|"     This study will examine the safety of ascending doses of AB-SA01 when topically applied to     intact skin of healthy adults.   "
40329|NCT02757742|"     The purpose of this study is to establish a quantitative LGE mass based scoring system     (including LGE mass on cardiac magnetic resonance , clinical features, specific medical     histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated     cardiomyopathy patients with reduced left ventricular ejection fraction   "
40330|NCT02757729|"     This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic     Dermatitis patients.   "
40331|NCT02757716|"     To evaluate addiction remission and addiction transfer after bariatric surgery.   "
40332|NCT02757703|"     Various vasoactive drugs are recommended to use in combination with endoscopic variceal     ligation (EVL) in treating acute esophageal variceal bleeding (EVB). The efficacy and drug     choice of vasoactive agents under Taiwan's National Health Insurance program remain to be     validated.      The aim of this prospective cohort study was to assess the efficacy of somatostatin, compared     with terlipressin in cirrhotic patients who have acute EVB and received EVL and the     preference of vasoactive agents in real-world clinical practice.      From April 2010 through April 2015, cirrhotic patients with significant upper     gastrointestinal bleeding were screened. Eligible patients with acute EVB were non-randomly     assigned to receive early administration of somatostatin (group S) or terlipressin (group T)     infusion, followed by EVL. A decision to use vasoactive drugs depended on the physician's     favorite. In group S, somatostatin by intravenous bolus (250 μg) followed by 250 μg/hour was     continued for 3 days. In group T, terlipressin was started with 2mg bolus injection and     followed by 1 mg infusion every 6 hours for 3 days.   "
40333|NCT02757690|"     Traditionally, laparoscopy has been based on 2-dimensional (2D) imaging, which has     represented a considerable challenge for those approaching this technique. Thus,     3-dimensional (3D) visualization technology for laparoscopy has been proposed, since the     early 1990s, as a way to facilitate laparoscopic performance. However, early 3D laparoscopic     technology was limited in terms of image quality, so that its use had not been implemented.     More recently, industry has developed novel 3D systems where the imaging is similar to     stereoscopic vision, in which the depth perception is achieved by different unique images     received by each eye. Thus, more recent studies have suggested a possible advantage provided     by these new 3D systems during laparoscopic performance. However, comparative assessments of     new generation 3D vs 2D laparoscopy remain limited, especially in the hepatobiliary and     pancreatic field.      To assess the benefits and harms of use of three dimensional systems versus two dimensional     systems during laparoscopic distal pancreatectomy.   "
40334|NCT02757677|"     The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based     Angiography (OCT-A) softwares in the diagnosis and management of glaucoma.   "
40346|NCT02757521|"     Investigators will study approximately 64 patients with Treatment-Resistant Bipolar     Depressive Disorder, defined as a failure of at least 1 antidepressants in the current     depressive episode and 2 lifetime medication failures. The study will last approximately 6 to     8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long     inhalation treatments over a week.   "
40972|NCT02749331|"     An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the     safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic     neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose.   "
40390|NCT02756949|"     This randomized controlled trial evaluates the provision of individual patient laboratory     results to newly diagnosed HIV positive smartphone users through a secure application (app)     as a method to get them linked to and retained in care, and engage with educational materials     purposefully developed to explain their results. Message prompts will also be used to alert     patients that their results are ready and provide information on how to link to care, and     assistance to re-link to care if they fall out of the health system for any reason. Prompts     will be sent to patients to remind health care workers if they are due for repeat laboratory     monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6     months. The control group received standard of care.   "
40520|NCT02755220|"     This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in     Aortic Valve Replacement and Mitral Valve Replacement in Chinese population   "
40335|NCT02757664|"     Background: There is no consensus regarding the treatment of insertional tendinopathies. The     good results of the eccentric training in the management of the non-insertional Achilles     tendinopathy were not reproducible in the insertional disease. Shock wave therapy is     described as an alternative to these patients.      Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents     better results that the eccentric strengthening associated to placebo.      Design: Double blinded (outcome assessor and patient) randomized clinical trial, with the use     of placebo, in parallel groups.      Materials and Methods: Nine-three patients with chronic insertional tendinopathy will be     enrolled in a randomized trial. Participants will be divided in two groups, one containing     the combination of shock wave and eccentric exercises as treatment and the other     comprehending the exercises assembled to placebo. The assessment of outcomes will occur in 2,     4, 6, 12 and 24 weeks of the beginning of the study. Patients will be evaluated for pain,     activity and function by the VISA-A (the Victorian Institute of Sport Assessment-Achilles     [VISA-A] questionnaire).   "
40336|NCT02757651|"     This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen     peroxide) for safety and activity in sensitising large cancerous lumps in the breast to a     standard course of radiotherapy in women with poorly controlled symptoms. Laboratory research     and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitiser     ('KORTUC') based on very dilute (0.5%) hydrogen peroxide injected into cancers under local     anaesthetic twice a week during radiotherapy greatly increases the effectiveness of standard     doses of radiotherapy alone. The side effects are limited to mild/moderate discomfort at the     injection site for up to 24 hours reported by Japanese breast cancer patients in whom this     treatment has been tested. Complete tumour shrinkage in 70/71 (98%) primary breast cancers up     to 5 cm diameter have been reported by Japanese collaborators.   "
40337|NCT02757638|"     Understanding how foods and nutrients are digested, absorbed and metabolized when weight is     stable and during weight loss induced by bariatric surgery procedure using the technologies     of genomics, transcriptomics, proteomics, metabolomics and fluxomics (omics) will enable     generation of new hypotheses that could explain the inter-individual differences in weight     loss and could lead to optimization and individualization of therapies designed to lose     weight.   "
40338|NCT02757625|"     To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous     IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years     old] requiring sedation under intensive care unit   "
40339|NCT02757612|"     The aim of this study was to report the effect of laser diode on the treatment of burning     mouth syndrome (BMS)      Patients were randomly allocated to two different groups:      the first one (group A) underwent Laser diode whereas the second one (group B) received Laser     diode inactive   "
40340|NCT02757599|"     Background: Transvaginal ultrasound training of novices is performed differently with respect     to the orientation of the ultrasound image. There is no international consensus on the     orientation of the transvaginal ultrasound image and no evidence to support whether one     orientation is superior to the other in terms of educational outcome and learning curves.      The aim of this study is to assess the effects of transvaginal ultrasound training when     orienting the image top-down versus bottom-up, which can open for the discussion concerning a     uniform transvaginal ultrasound education. This study may improve ultrasound novices'     learning and potentially ensure that future clinicians perform transvaginal ultrasound     examinations in the same manner.      Hypotheses: The investigators hypothesize that the orientation perceived by ultrasound     novices, as the most intuitive will result in lower cognitive load during training and result     in shorter learning curves and improved transfer of skills to various settings and cases.   "
40341|NCT02757586|"     CLL is a disease of the elderly, identifying effective therapies with better toxicity     profiles is thus a high priority, and targeted therapies may allow attainment of this goal.   "
40342|NCT02757573|"     The aims of the study is to investigate the right ventricular responses to mild hypercarbia     after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial     catheter and transesophageal echocardiography.   "
40343|NCT02757560|"     The overall goal of the proposal is to use a saturated fatty acid (SFA)- enriched, high fat     diet to rapidly induce insulin resistance (IR) to provide insight into underlying proximal     mechanisms of reduced insulin signaling. Specifically, investigators will identify the     initial changes in metabolite concentrations/or pathway signaling (pathways will be used to     broadly refer to these mechanism specific measures) and therefore the mechanisms most likely     responsible for the development of IR during this high fat nutritional challenge.     Investigators have assembled a multidisciplinary team that is versed with dietary studies,     fatty acid metabolism, measurement of IR and potential mechanisms and mediators of IR, and     has experience working with monocytes and the two tissues, muscle and adipose tissue, that     are particularly relevant for understanding the effects of high fat diets on IR.   "
40344|NCT02757547|"     The goal of the present clinical trial is to determine whether low frequency (0.5 Hz) rTMS     can induce long term depression in epileptogenic cortex and thus suppress cortical     excitability at the epileptic focus.   "
40345|NCT02757534|"     The purpose of this study is to provide oral domperidone to patients with gastroparesis,     between the ages of 18 and 60 years of age, who have failed standard treatment. Standard     therapy at the University of Iowa is eating blended foods, liquid diet, Eryped syrup (125 mg     TID) 30 minutes before meals, or reglan (20 mg BID).   "
40391|NCT02756936|"     An open label randomized, single dose, two-way crossover bioequivalence study to determine     the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm     Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma,     UK) in Healthy Human Volunteers Under Fasting Condition   "
40521|NCT02755207|"     The purpose of this study is to evaluate the potential diagnostic and prognosis value of     circulating microRNAs compared with cTnI for suspected ACS patients at the emergency     department (ED) and intensive care unit (ICU).   "
40347|NCT02757508|"     This study is to gather information on school feeding programs and to measure the effect on     linear growth and cognitive performance when providing a high-quality milk protein source or     a combination of a high-quality milk protein source and rice proteins as a nutritional     supplement to school children in Ghana. Children will receive a meal with a protein powder     supplement with vitamins and minerals mixed into it. Participation is expected to last for 9     months.      1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary     schools (60 per school). Participants will be randomized to one of four groups: Control:     Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF     recommendations.      For groups 1-3 the same vitamin/mineral mix will be used along with Group 1.     Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the     sugar lactose.      Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk     protein powder and the plant protein is a rice protein concentrate and the sugar lactose.      Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein     powder with the sugar lactose.      At baseline measurements-weight,height,mid-upper arm circumference,and body composition will     be taken, fasting blood spot test will be administered to measure levels of Insulin and     insulin like growth factor, and computer based cognitive testing. Demographic information     will be collected along with a dietary survey. Primary outcomes are cognitive performance on     standardized tests and change in height-for-age z-score over the supplementation period, 9     months total. Questionnaires will be administered to collect demographic data and dietary     information.      At the mid-point all measurements will be taken again and cognitive testing will be repeated.      At the end of the study all measurements will be taken again, cognitive testing repeated,     blood spot samples taken again, and a short survey will be administered about the protein     powders.   "
40348|NCT02757495|"     Emergence agitation (EA) is common phenomenon in pediatric patients undergoing general     anesthesia by inhalation agents. The incidence of EA was reported to range from 18% to 80%.     Sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, Different     strategies have been suggested to decrease the incidence and severity of EA. No gold standard     technique for treating EA after sevoflurane anesthesia is currently available. The main     question is can caudal dexmedetomidine be used for this purpose?   "
40349|NCT02757482|"     The purpose of this study is to examine the effects of patient training about the safety of     warfarin therapy on related knowledge levels and on International Normalized Ratio (INR)     control.   "
40350|NCT02757469|"     Premature ovarian insufficiency (POI) is a life-changing condition that affects women in     their reproductive age. There is a lack of reports which focus on how to improve the     reproductive outcome of these women who wish to conceive spontaneously or use assisted     conception with their own oocytes. However, one could surmise that it is important to lower     gonadotropin levels into the physiological range before embarking on any treatment, even if     natural conception is the only choice for the woman/couple.   "
40351|NCT02757456|"     Arterial calcification is very common in the incident hemodialysis population, ranging     71-83%.Given that cardiovascular disease is a major cause of mortality in the hemodialysis     population, medial arterial calcification may contribute through increased risk of sudden     death and congestive heart failure. Applanation tonometry is the method of choice to measure     pulse wave velocity and pulse wave analysis. The primary objective will be to assess the     effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter     and gait speed as the physical functioning parameter. The secondary objectives will assess     the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP,     hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin,     hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.   "
40352|NCT02757443|"     There is evidence on the role of the phosphotransfer system in the energy metabolism of the     heart, with altered energetics playing an important role in the mechanisms of heart failure.     Phosphocreatine plays an important part in the energy heart system. The investigators have     just performed a systematic review and meta-analysis of randomized controlled trials (RCTs)     and matched studies that compared phosphocreatine with placebo or standard treatment in     patients with coronary artery disease or chronic heart failure or in those undergoing cardiac     surgery. Patients receiving phosphocreatine had lower all-cause mortality as well as improved     cardiac outcomes when compared to the control group, however, the quality of the included     studies was low. Thus, the investigators plan to conduct an exploratory high quality RCT to     investigate whether providing phosphocreatine compared to placebo improves the myocardial     protection in high-risk patients scheduled for cardiac surgery and to determine the best     research endpoint for future trials.   "
40353|NCT02757430|"     The objective of this registry is to assess and characterize the use and performance of the     EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a variety     of electrophysiological (EP) procedures and clinical settings. This registry will assess the     clinical performance of the system in a controlled, real-world environment after commercial     release.      Up to 500 subjects will be enrolled in up to 50 sites worldwide.      Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no     long-term follow-up required for this registry.      The anticipated registry enrollment is about 6-7 months.   "
40354|NCT02757417|"     To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during     gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result     in shorter cystoscopy times.   "
40355|NCT02757404|"     Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.   "
40356|NCT02757391|"     The goal of this clinical research study is to learn if it is safe to deliver a CD8+T cell     therapy to patients with advanced gastrointestinal cancers.      This study will use your tumor cells (either from a fresh biopsy or from leftover tissue     samples) and blood to help create a T cell immune-based therapy designed specifically for you     based on what the study doctor and research staff can learn about the type of mutated     proteins (a type of genetic change) in the tumor.   "
40357|NCT02757378|"     This study evaluates whether different explanations given to patients with long lasting back     pain influence a physical therapy treatment technique. Half of the patients will receive an     explanation of the proposed treatment technique focusing on how their joints are moving and     not moving. The second half of the group will receive the same treatment technique as the     first group, but their explanation of the technique's purpose will focus on how their brain     interprets the information. The study aims to determine if patients have a different response     to the treatment based on the words chosen to explain the technique.   "
40392|NCT02756923|"     Investigative trial to evaluate the role of a glial cell lined derived neurotrophic factor     (GDNF) in regulation of spermatogonial renewal and testicular function. Goal of the trial is     to provide greater information on the mechanisms that effect stem spermatogonial maintenance     renewal and proliferation in its relation to male infertility.   "
40358|NCT02757365|"     Though the pathogenesis of prostate cancer (PCa) is still obscure, it has been reported, by     investigators previous studies and some other researches, that PCa is often combined with     tissue inflammation which is closely related to prostate specific antigen (PSA) level.     Inflammation could play an important role in the process of occurrence and development of     PCa, however the mechanism is unknown. Inflammatory cytokines could not only mediate     inflammatory reactions, but also participate in the growth, proliferation, invasion and     progression of tumor cells. It has been found that non-steroid anti-inflammatory drugs     (NSAIDs), such as aspirin, can effectively prevent several inflammation related tumor, and     coincidentally, PCa is also closely associated with inflammation. Moreover, latest researches     demonstrated that hormone therapy could induce tissue inflammation in PCa, in which a large     quantity of immune B cells were attracted into the focal and then a lot of cytokines, such as     IKK-β, NF-κB, were released. These cytokines could inhibit apoptosis and promote the growth     of tumor cells, which might be a possible mechanism for long-term inflammatory infiltration     inducing the occurrence of PCa and the transformation to castration-resistant prostate cancer     (CRPC). Based on these proofs, investigators presume it could be possibly an effective way to     prevent the occurrence of PCa and the transformation from androgen-dependent prostate cancer     to CRPC by means of long-term oral aspirin. In this study, investigators intend to explore     the possible effect of anti-inflammatory therapy on the progress of transformations from     inflammation to PCa and from androgen-dependent prostate cancer to CRPC. Investigators plan     to conduct both clinical trials in four groups, including the control group, the NSAIDs     group, the antibiotics group and the NSAIDs+antibiotics group, and a basic experiment in     vitro to assess the effectiveness of anti-inflammatory drugs and elucidate the specific     molecular mechanism.   "
40359|NCT02757352|"     The main purpose of this study is to evaluate the safety and efficacy of the study drug known     as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants     with nonradiographic axial spondyloarthritis (nonrad-axSpA).   "
40361|NCT02757326|"     This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of     sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple     myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been     treated with proteasome inhibitors and immunomodulatory agents will receive increasing doses     of oral ABC294640. The starting dosage for ABC294640 will be 250 mg bis in die (BID) which is     known to be safely tolerated as a single agent, and the ABC294640 dose will be escalated to     two additional dose cohorts of 500 and 750 mg BID using Bayesian model average continual     reassessment method (BMA-CRM) for dose finding. It is expected that 18 patients will be used     to determine the maximum tolerated dose (MTD) for ABC294640 in refractory or relapsed MM. Up     to 56 additional patients will be treated on the phase II portion of the study at the MTD or     maximum dose used in phase I, with interim stopping rules for futility.      Pharmacokinetic (PK) and pharmacodynamic (PD) assessments of ABC294640 will be conducted on     Day 1 of Cycle 1. Bone marrow biopsy will be obtained prior to the initiation of ABC294640,     at the end of cycle #3 and at the end of cycle #6. In addition to serum protein     electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chain     measurement, correlative studies will be performed to measure sphingosine kinase 2 (SK2)     activity, sphingosine metabolites, and additional biomarkers in CD138+ myeloma cells.   "
40362|NCT02757313|"     Marijuana is one of the most widely used substances. However, marijuana intoxication is not     fully understood in relation to driving. This study will help the investigators learn more     about the potential impairments related to marijuana intoxicated driving. A combination of     MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to     measure intoxication and impairment. This study will also assess levels of marijuana in blood     and saliva samples. This study takes place in Hartford, Connecticut.   "
40363|NCT02757300|"     After approval of the Institutional Review Board and written patient´s informed consent     patients with indication for surgery of the sinuses were randomly assigned to one of the two     study groups. After standardized anaesthetic management and PONV prophylaxis routinely     applied the patients were screened for mucosal injury on second postoperative day.     Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV     were recorded throughout the hospital stay.   "
40364|NCT02757287|"     Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily     injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th     stimulation day until ovulation induction with a bolus of another injection of a     gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid     untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular     aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone     (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous     injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a     contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception,     avoiding the LH surge. It has been described the usefulness of orally administered     medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during     COS.      In donors, by administering a single injection of FSH-CTP and oral desogestrel since the     first menstruation day, the total number of injections administered is reduced and less     discomfort is experienced without adverse impact on ovarian response. No description of the     hormonal and ovarian response under this protocol has been published   "
40365|NCT02757274|"     This will be a prospective collection of pre-defined parameters on the treatment of male     stress urinary incontinence by an artificial urinary sphincter (AUS) and male sling. The data     collection will be undertaken from multiple centers in Europe. The participation will be by     open invitation to all members of the Female & Functional Section of the EAU (ESFFU) along     with other urologists undertaking these procedures. There will be a call via the European     Association of urology (EAU) to all European Urologists to register for database entry. There     will be no restriction on the number of patients enrolled as long as they are consecutive.     The aim is to have a long term collection of the data set from as many centers as possible.     An initial assessment for the robustness of the data collection will be undertaken at 3     months by a nominated steering committee. However, the first clinical evaluation of the data     collected will commence at 1 year by the steering committee. Thereafter, the evaluations will     be performed after every 2 years.   "
40408|NCT02756715|"     Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx     of blood flow. syndecan-1 was a marker of glycocalyx.      The purpose of this study is to prove the variation of level of serum syndecan-1 between     preoperative and postoperative period.   "
40366|NCT02757261|"     Bruxism is a repetitive activity of the masticatory muscles characterized by grinding and/or     clenching one's teeth or parafunctional movements of the mandible. The aim of the proposed     controlled clinical trial is to evaluate muscle activity, bite force and salivary cortisol in     children aged six to eight years with bruxism. The children will be randomly allocated to     four groups, each with 19 participants: Group 1 will receive low-level laser therapy at     acupuncture points; Group 2 will use an occlusal splint; Group 3 will receive placebo laser     therapy; and Group 4 will be the control group without bruxism. Low-level laser (786.94 nm,     0.04 cm2, 70 mW and 20 s per points) will be applied directly on the skin at six acupuncture     points on each side. The BTS TMJOINT electromyograph will be used to determine muscle     activity and a digital gnathodynamometer will be used to measure bite force. Two saliva     collections will be performed in the participant's home at 9 am and prior to going to sleep,     with at least one hour of fasting and followed by oral hygiene with water. Evaluations will     be performed before as well as one and six months after treatment. The findings will be     computed and submitted to statistical analysis. Descriptive statistics will be used first for     the determination of point estimates, precision and validation using analysis of variance     (ANOVA) for the evaluation of residuals and parametric tests will be used for the     determination of pre-treatment conditions. Interval estimates will be used for the variables     of interest to determine the prevision of the estimates and perform comparisons. When     necessary, transformation methods or non-parametric tests will be used in the data analysis.     The chi-square test, Student's t-test and ANOVA will be employed, with the level of     significance set at 5% (p < 0.05).   "
40367|NCT02757248|"     This is a phase I study of the combination of volasertib and romidepsin in patients with     relapsed/refractory peripheral T cell lymphoma (PTCL) or stage IIB-IV cutaneous T cell     lymphoma (CTCL). This study will determine the maximum tolerated dose (MTD) of this     combination by treating cohorts of patients at a certain dose combination. The investigators     will use a Bayesian design to determine the dose combination for the next cohort of patients     and to determine the MTD. Overall response rate as well as adverse events will be monitored     and reported.   "
40368|NCT02757235|"     The study will be a multicenter randomised controlled trial of the use of irrigation fluid of     body temperature versus irrigation fluid of room temperature during burr hole evacuation of     chronic subdural hematoma.   "
40369|NCT02757222|"     The primary objective of the study is to establish the safety of using a moderate escalation     of radiotherapy dose in advanced/poor prognosis OPC and LH cancers receiving curative     radiotherapy.      The study will also explore the efficacy (improvement in complete response rates at 2 years)     of dose escalation in intermediate and high risk OPC and LH cancers patients.   "
40370|NCT02757209|"     This is a randomized, multi-center, active-controlled, repeated measures design study in male     and female patients 60 years of age and older with persistent asthma or COPD.      Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano     delle Murge (Ba), Tradate.      The primary efficacy parameter of the study is inhaler device usability (expressed as total     number of repeated attempts required to achieve optimal use).   "
40371|NCT02757196|"     a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial     performed in 5 departments of hematology in China   "
40372|NCT02757183|"     The INTELLIH (brand name of the mobile health application) Diabetes Study is to understand     the usage of a mobile health application, IntelliH, and connected wireless devices such as     glucometer by the diabetic patients and ascertain if there are any improvements in short-term     health outcomes.   "
40373|NCT02757170|"     Patients of acute & chronic liver failure have long been assumed to have coagulopathy & are     given blood products prophylactically as well as during various interventions. But these     patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation     parameters are insufficient to assess coagulation status of these patients because they     reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives a     comprehensive report of hemostatic profile including platelet function. Studies using TEG     have suggested that defects in prohemostatic drivers are counterbalanced by changes in     antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a     entity with acute decompensation on underlying chronic liver failure. Since there is paucity     of data regarding coagulation abnormalities in these patient, study is needed to assess     predictability power of TEG in these patients with respect to coagulation abnormalities in     patient with ALF and CLD ( cirrhosis) and healthy controls.   "
40374|NCT02757157|"     The purpose of this study is to evaluate the metabolic load during a single session of     moderate intensity walking in water compared to walking on land (over-ground) in people with     chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with     peak exercise metabolic response.      The hypothesis is that the metabolic load of walking at a moderate intensity in water will be     greater than walking on land.   "
40375|NCT02757144|"     This is a dose block-randomized, double-blind, placebo- and active-controlled, single and     multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety,     tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in     healthy male volunteers.   "
40376|NCT02757131|"     Bedrest and lack of mobility in the inpatient hospital setting hastens the functional decline     of elderly patients and is associated with increased risk of complications such as falls,     delirium, venous thrombosis, and skin breakdown. These adverse health effects drive increased     cost as patients spend additional time in both the acute (hospital) and post-acute care     settings. Physical activity is thus widely recognized as an important factor for improving     outcomes in hospitalized patients; however, numerous challenges to its implementation exist.     Specifically, although it has been found that with small increases in physical activity such     as increasing number of steps by only 600 daily for inpatients, length of stay can be reduced     by nearly 2 days, usual care in many hospitals, including the Cleveland Clinic, does not     include exercise, and physicians do not all regularly order physical activity for their     hospitalized patients. Even when activity is recommended or ordered, compliance and execution     of the orders has been spotty and/or negligible. It is therefore clear that the current     system for the provision of ambulation is ineffective. The investigators hypothesize that a     graded protocol of ambulation which can be implemented by a dedicated patient care nursing     assistant (PCNA) multiple times daily will provide significant benefit to patients without     the labor and cost requirements of full-time nursing and physical therapy expertise. The     objective of this study is to assess the feasibility and effectiveness of dedicated     ambulator-assisted physical activity in elderly inpatients. The primary hypothesis is that an     ambulator-assisted intervention for hospitalized elderly inpatients will prove feasible and     may result in improved hospital outcomes, including less need for inpatient rehabilitation     and shorter length of stay in the hospital. This study will provide pilot data for a larger     randomized trial.   "
40377|NCT02757118|"     After obtaining approval from the Institutional Review Board of our institution, written     informed consent is obtained from patients undergoing cardiac surgery are enrolled in this     prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES     (n=15).      All recruited patients will be given patient identification number (PIN) for the present     study of 01-30 according to their order of interview and recruitment. Investigators will     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30     (Envelop number). After printing the envelope number outside envelope, all sealed envelopes     with cards will be conveyed to and kept in pharmacy department.      According to the color of the card, attending anesthesiologists will give crystalloid for     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.      Patient data and statistical analyses:      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be     determined from the patients' medical record after patient's discharge.      All statistical analyses will be performed after the 30th patient's discharge and data     acquisition   "
40378|NCT02757105|"     This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After     qualifying for the study and signing informed consent, patients will undergo a two-week     observation period during which stool consistency and frequency data and symptom data will be     collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo.     Patients will continue on treatment for 8 weeks. Each medication will be given once daily.   "
40379|NCT02757092|"     Pulmonary rehabilitation has been demonstrated by evidence-base medicine to reduce the     pulmonary complications after thoracic surgery. According to the literature reviews, these     studies did not specifically point out the proper timing for the intervention of pulmonary     rehabilitation on patients with thoracic surgery; moreover, interventions about pulmonary     rehabilitation that focused on long-term training have not been studied. The purpose of this     study is to determine whether Pulmonary rehabilitation are effective on patients who had     thoracic surgeries.   "
40380|NCT02757079|"     The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep     diaries and the safety of NPC-15.   "
40381|NCT02757066|"     The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d)     versus placebo to sleep latency with electronic sleep diaries.   "
40382|NCT02757053|"     Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery     (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post     season on high school football players. One set of players will wear the Guardian Cap on     their five star rated helmets and the other will wear five star rated helmets only. The     investigators will compare outcomes of ImPACT scores and MRI findings between the two groups     to see if there is a statistical difference in reduction of injury and to establish what the     baseline level of MRI findings related to injury from high school football is as well as what     the baseline level of injury is prior to the start of the season.   "
40383|NCT02757040|"     The purpose of this study is to determine whether the combination of As2O3 and ibrutinib is     synergistic in chronic lymphocytic leukemia   "
40384|NCT02757027|"     After obtaining approval from the Institutional Review Board of our institution, written     informed consent is obtained from patients undergoing CABG surgery are enrolled in this     prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES     (n=15).      All recruited patients will be given patient identification number (PIN) for the present     study of 01-30 according to their order of interview and recruitment. Investigators will     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30     (Envelop number).      According to the color of the card, attending anesthesiologists will give crystalloid for     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.      Patient data and statistical analyses:      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be     determined from the patients' medical record after patient's discharge.      All statistical analyses will be performed after the 30th patient's discharge and data     acquisition   "
40385|NCT02757014|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
40386|NCT02757001|"     Spanish registry of retrievable vena cava filters.      This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology     (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive     Techniques) of the University of Zaragoza (Spain).      A software tool hosted on the official website of SERVEI and the journal Intervencionismo     will be used for data collection a(https://estudios.watsoncme.com).   "
40387|NCT02756988|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
40388|NCT02756975|"     Prostate tissue biopsy is performed with either transrectal or transperineal approach. These     two methods are usually based on tissue sampling with an ultrasound-guided core needle     biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial     technique or with a coaxial technique. In conventional transperineal technique, biopsy needle     is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can be     placed over the perineum; then, the direction of the biopsy can be changed by tilting the     coaxial needle. In this prospective study, the investigators sought to compare the procedural     time and the complication rate of coaxial technique with those of noncoaxial technique in     transperineal prostate biopsy.   "
40389|NCT02756962|"     The investigators will prospectively determine whether the relapse-free and overall survival     in patients who have cleared their leukemia-associated mutations treated with standard     consolidation chemotherapy is superior to what is expected based on historical controls. The     investigators will also prospectively determine the relapse-free and overall survival of     patients who have not cleared their mutations. Because the relapse rate of patients with     persistent mutations is expected to be high, treatment with either standard of care     consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating     physician.   "
40393|NCT02756910|"     A new wireless axillary thermometer from Raiing Medical uses a proprietary system,     iThermonitor (WT701), to provide better estimates of core temperature than a conventional     axillary probe. Improvement results in part because the axillary probe measures and records     temperatures continuously every 4 seconds and includes software to compensate for ambient     temperature and positional changes including arm abduction.      Whether the iThermonitor is sufficiently accurate for clinical use remains unknown. The     investigators thus propose to evaluate the system in perioperative patients who often     experience thermal perturbations over a range of several °C. Specifically, the investigators     propose to determine the precision and accuracy of iThermonitor in surgical patients and     during the initial hour of recovery. As in previous studies, the investigators will consider     the thermometer sufficiently accurate for clinical use if most Raiing temperatures are within     ±0.5°C of the reference temperature.   "
40394|NCT02756897|"     The goal of this clinical research study is to learn if venetoclax given in combination with     ibrutinib can help to control CLL or SLL. The safety of the drug combination will be also     studied.   "
40395|NCT02756884|"     This is a single center, open label, prospective, randomized, controlled study in patients     with non- revascularizable moderate or severe lower extremity Peripheral Arterial Disease     (PAD) receiving autologous stem cells therapy (minimally manipulated). This study will enroll     a maximum of 10 subjects in this study. The patients will be divided into two groups. One     group will receive Adipose Derived Stem Cells (ADSCs) alone and the other group will receive     low frequency ultrasound before the addition of ADSCs. The randomization will be 1:1. If the     results of this pilot study are not clearly different, there will be a need for a phase II     study to support the results.      Baseline, 6 week, 3 month and 6 month assessments of 6 min walking distance (6MWT), Ankle     Brachial Indexes (ABIs)/Toe Brachial Indexes (TBIs), Transcutaneous Partial Oxygenation     (TcPO2) and Rutherford assessments will be performed for the study group. Prior to the stem     cell treatment, the ultrasound group patient will receive noninvasive transcutaneous pulsed     focused ultrasound around the involved vessel(s) in the affected extremity. All patients will     then receive 200 million autologous stromal vascular fraction cells containing adipose     derived stem cell therapy: 1/3 of the cells will be delivered intra-venous proximal to the     lesion (not retrograde), 1/3 of the cells will be delivered intra- adventitia proximal to the     lesion and 1/3 of the cells will be delivered by intra- muscular injection along the vessel     path (20-30 injections each separated by1.5 inch). Standard therapy for PAD patients will not     be interrupted for the duration of the study. Standard therapy for PAD is defined as     cardiovascular general measures like lifestyle changes, smoke cessation, exercise,     cardiovascular rehabilitation, etc. All participants have already received maximal     non-surgical therapy. Safety will be monitored on an ongoing basis.   "
40396|NCT02756871|"     The purpose of this study is to assess the effectiveness of CBT based online guided self-help     intervention for perfectionism at reducing symptoms of perfectionism and Axis I disorders     post-treatment and at six-month follow-up.   "
40397|NCT02756858|"     This open label extension study is designed to provide continued access to ANAVEX 2-73 for     eligible subjects with mild to moderate Alzheimer's Disease who have previously participated     in the Anavex sponsored study ANAVEX2-73-002.   "
40398|NCT02756845|"     This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec     administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct     injection   "
40399|NCT02756832|"     The purpose of this study is to observe clinical response to treatment with alogliptin     benzoate (Vipidia) utilization patterns in standard clinical practice.   "
40400|NCT02756819|"     The purpose of this study is to estimate antihypertensive effect of azilsartan medoxomil     (Edarbi®) therapy on blood pressure in participants with overweight or obesity in routine     clinical practice of hypertension (HTN) treatment in the Russian Federation and in the     Republic of Kazakhstan..   "
40401|NCT02756806|"     Evaluate safety and efficacy with the enlighten laser for tattoo removal.   "
40402|NCT02756793|"     A multicenter randomized phase II trial of stereotactic body radiotherapy for     oligo-progressive non-small cell lung cancer. Eligible patients will be randomized in a 1:2     ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy     (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon as     possible following randomization, and subjects will be followed until next disease     progression. The primary outcome is progression-free survival (PFS).   "
40403|NCT02756780|"     'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to     provide social support and improve mental wellbeing amongst those affected by cancer, whether     patients, carers or staff. Research has already demonstrated that these choirs can reduce     depression and anxiety amongst participants and improve social support networks and quality     of life as well as preliminary evidence that they can reduce levels of stress hormones and     improve immune function. The aim of this study is to establish more about the psychological     benefits of regular choir singing and explore whether the biological changes noted in pilot     studies can be sustained over time. This could identify whether choirs have the potential to     optimise health in people affected by cancer, helping to put patients in the best position to     receive treatment or maintain remission and supporting those who care for someone with     cancer, whether professionally or informally.   "
40404|NCT02756767|"     The goals of this study are to assess the feasibility of weekly administration of site     specific patient reported assessments using an electronic platform and to explore the     correlation between patient reported outcomes as well as known dosimetric prognostic factors     in patients with lung, breast, head and neck, or pelvic malignancies   "
40405|NCT02756754|"     The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a     prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma     concerning the efficacy on blood pressure control. The safety of the procedure is one of the     secondary outcomes.   "
40406|NCT02756741|"     The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a     third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on     day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high     price of albumin. In the current randomized control trial investigators compared the effect     of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose     (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid     and blood.   "
40407|NCT02756728|"     The purpose of this study is to investigate the safety and efficacy of administering BI-505     in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma     patients.   "
40441|NCT02756286|"     The purpose of this study is to refine a new assessment tool for Attention     Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to     discriminate between individuals with ADHD and healthy controls.   "
40409|NCT02756702|"     Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing     surveillance plan for the product under investigation For this PMCF only CE-marked medical     devices will be used within their intended purpose and no additional invasive or other     stressful examinations are to be carried out (acc. to MPG §23b).   "
40410|NCT02756689|"     The investigators are performing a randomized controlled-trial investigating starting     cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley     catheter. This is a pilot study to establish the efficacy of this method in decreasing time     as in inpatient and evaluate patient satisfaction.   "
40411|NCT02756676|"     This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative     program on quality of life in patients with Parkinson's Disease.   "
40412|NCT02756663|"     The purpose of this study is to investigate the anti-myeloma effect of panobinostat given at     two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2 i.v.)     and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in     patients with relapsed or relapsed and refractory multiple myeloma. Safety and efficacy will     be evaluated. Treatment will be administered in 4-week cycles until patients discontinue due     to disease progression or unacceptable toxicity or for other reasons.      Patients who discontinue the study treatment for reasons other than documented disease     progression will be followed for disease assessments every 8 weeks until progression. All     patients will be followed for survival until 3 years have passed from their entry into the     study, or they have discontinued the follow up earlier.   "
40413|NCT02756650|"     Primary objective of the study is to evaluate the safety and efficacy of canakinumab on the     clinical and inflammatory findings of Behced Disease patients with neurologic and vascular     involvement.   "
40414|NCT02756637|"     The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs     value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline     NLR is correlated with overall survival after curative treatment for BC and 2) that baseline     NLR is correlated with the survival benefit of NAC. The study will look at the data from     participants of the SWOG 8710 study.   "
40415|NCT02756624|"     This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution   "
40416|NCT02756611|"     The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax     monotherapy in approximately 250 participants with relapsed/refractory CLL including those     with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received     prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg     once daily. The dose must be gradually increased over a period of 5 weeks up to the daily     dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the     treatment period, participants may continue on into a 2-year follow-up period.   "
40417|NCT02756598|"     Patients scheduled for elective cardiac surgery are preoperative evaluated using different     personality type, stress and anxiety tests.      Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus     1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and     propofol 0.06 mg/kg/min).   "
40418|NCT02756585|"     Traumatic brain injury (TBI) is a leading cause of post-injury hospitalization, disability,     and death worldwide. In Nova Scotia, approximately 50% of major trauma reported is head     trauma. TBI is predicted to be the most common and expensive neurological condition in Canada     through the year 2031.      Families and medical teams must often decide on the appropriate level of care for patients     with severe TBI and frequently need to consider withdrawal of life support measures. These     decisions have implications for patients with severe TBI, costs to the health care system,     and rates of organ donation.      A reliable method for neurological evaluation at the time of the patient's arrival to the     hospital is important, because it is possible that many patients with severe TBI already have     permanent brain damage. Assessing this brain damage with clinical tests is difficult because     of the nature of patients' injuries and the sedative medication they receive at the time of     their hospital admission. Current standard imaging technique for these patients is severely     limited in the assessment of the extent and severity of the brain damage.      Advanced diagnostic imaging, called Computed Tomography Perfusion (CTP), can help detect     permanent brain damage. However, CTP of the head is not currently done for patients with     severe TBI when they arrive at the hospital. The investigators want to test whether CTP of     the head can detect permanent brain damage among patients with severe TBI.   "
40419|NCT02756572|"     This clinical trial studies how well early stem cell transplantation works in treating     patients with high-grade myeloid neoplasms that has come back after a period of improvement     or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine,     cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving chemotherapy before a donor peripheral blood cell transplant     helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem     cells) and cancer cells. When the healthy stem cells from a donor are infused into the     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood     cells, and platelets. The donated stem cells may also replace the patient?s immune cells and     help destroy any remaining cancer cells. Early stem cell transplantation may result in more     successful treatment for patients with high-grade myeloid neoplasms.   "
40420|NCT02756559|"     Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process     of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction.     Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have     showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in     sepsis. The present research further study the regulatory mechanism of those miRNAs in     lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a,     miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in     regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new     targets for sepsis treatment.   "
40421|NCT02756546|"     This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in     plasma of SLE patients and difference in their expression among groups with different     systemic lupus erythematosis disease activity index (SLEDAI) scores.   "
40422|NCT02756533|"     COPD is characterized by non-reversible chronic airway obstruction. Its evolution is     punctuated by successive exacerbations precipitating the progression of the disease and its     co-morbidities. The most severe exacerbations are the source of frequent hospitalizations     that strongly affect the patient's quality of life and are associated with increased     mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult     their doctor too late which may lead to delays in care. However, the early detection and     management of these exacerbations can reduce their impact and in particular avoid     hospitalization or shorten their duration.      In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in     COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. The     investigators have demonstrated in a previous study that the analysis of parameters from     software embedded in the NIV device can reliably predict the occurrence of an exacerbation.     The investigators hypothesize that the daily transmission via a telemonitoring platform of     the ventilation parameters of patients, together with an ad hoc warning system, would reduce     the rate of hospitalization for COPD patients treated at home with NIV thanks to the early     detection and early treatment of these exacerbations.      The purpose of the study is to compare if a program of telemonitoring using the parameters     stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory     symptoms in COPD patients versus standard care over a one year period.   "
40423|NCT02756520|"     The purpose of this study is to characterize the patient and disease profile under the     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),     focusing on the progression of chronic renal insufficiency, calcium and phosphorus     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as     the persistent dietary education to ensure compliance in a large group of pre-dialysis     patients.   "
40424|NCT02756507|"     Anxiety and depressive disorders are common in adolescents, however they are often     unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral     therapy (CBT) is efficient for children and adolescents. School settings are appropriate     environments to deliver such interventions for vulnerable youths. Given youth's access and     predilection to use technology, a video-based prevention program was developed. The present     study aims to investigate the efficacy of a transdiagnostic REBT prevention program for     internalizing symptoms in adolescents, implemented in a school setting.      Classes from different Romanian public schools will be randomized in either intervention or     wait list group.   "
40425|NCT02756494|"     Stroke is the fifth leading cause of death in the United States and the leading cause of     disability. However, in China, stroke is one of the most frequent causes of death and chronic     disability. Ischemic strokes in adults younger than 45 years of age were regarded as a     relatively uncommon event in the proportion of <5% of all ischemic strokes.   "
40426|NCT02756481|"     To characterize treatment patterns and healthcare resource utilization among adults diagnosed     with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela.   "
40427|NCT02756468|"     Background. Pancreatic cancer surgery is associated with very high risk of postoperative     morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated     with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to     monitor bacterial infections and guide antibiotic therapy and has been shown to have better     predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood     cell count (WBC).      Purpose. The investigators designed a monocentric pilot study to test if PCT might be a     sensitive and reliable marker of AL after pancreatic surgery   "
40428|NCT02756455|"     Background. Gastric cancer surgery is associated with high risk for postoperative morbidity     and mortality. Anastomotic leak (AL) is one of the worst complications associated with     relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor     bacterial infections and guide antibiotic therapy and has been shown to have better     predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood     cell count (WBC).      Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive     and reliable marker of AL after gastric surgery   "
40429|NCT02756442|"     Introduction:      The pregnancy brings about physiological and hormonal modifications which cause sleep     disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the     pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The     limited airflow causes micro-awakenings that enter in the frame of the high resistances     airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at     pregnant women.      Objectives:      To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman     with or without gestational diabetes      Methods :      It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who     consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going     to compare the breathing disorder during sleep of a control group with a group of women with     gestational diabetes. A polysomnograph will be run at the included patients' home.      Expected results :      The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep     events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational     diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that     limited airflow in association with micro-awakenings in the RERA have a negative impact on     the glucose metabolism and favor the gestational diabetes.   "
40442|NCT02756273|"     During the creation of an ileostomy, a bridge device is systematically placed in an aim to     reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to     justify this issue.      Moreover the placement of a bridge device increases the difficulty of nurse cares and is     associated with its own morbidity.   "
40445|NCT02756221|"     The study will evaluate the change in gastrointestinal (GI) flora following probiotic     supplementation, and expected to lead to an increase in the intestinal epithelial integrity     and to improvement in its health. Concurrently with the reduction in the amount of toxins in     the GI tract following an intensive exercise, a lower incidence of symptoms of discomfort     will improve the quality of the training sessions which will be exhibited by an improvement     in endurance capacity and in physiological responses to rigorous exercise. Half of the     participants will receive probiotic supplement while the other half will receive a placebo.   "
40430|NCT02756429|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia. Because of its major impact     on the general morbidity and risk of stroke, AF is a great concern for public health. Several     mechanisms, including endothelial dysfunction and inflammatory processes, have been     postulated as predisposing factors for AF, as well as for stroke.      Both clinical and experimental studies highlight inflammation as a predisposing factor for AF     and its complications. Nevertheless, the source of high inflammatory proteins in patients     with AF is still unknown. We hypothesized that multilevel intracardiac and extracardiac (left     femoral vein, coronary sinus, left atrium, pulmonary vein) measurements of several     inflammatory proteins (VEGF) would help assessing the extent and the source of inflammation     in AF patients.      The measurement of von Willebrand factor (vWF) levels in multiple vascular sites would also     help to define the site of endothelial dysfunction and of production of this thrombogenic     factor.      Although AF is associated with an increased risk of stroke, the risk is not homogeneous.     Permanent and persistent AF are associated with similar thromboembolic risk to that of     paroxysmal AF.   "
40431|NCT02756416|"     This study aims to quantify perfusion, assess arterial vasoconstriction, and confirm     reversibility using 3T ASL-MRI and MRA in 10 patients with suspected RCVS. Acquiring these     data at multiple time points during RCVS progression, the investigators will assess the     relationship between vasoconstriction and downstream perfusion and determine the role of     these imaging techniques in early and accurate diagnosis of RCVS. The investigators also aim     to investigate whether early imaging abnormalities can predict RCVS complications and     clinical outcomes.   "
40432|NCT02756403|"     This study, a double blinded randomized controlled trial, is being done to compare side     effects of commonly used antibiotic regimens prior to same day abortion procedures.      In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks     gestation) will be randomized to receive one of the three commonly used antibiotics     (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior     to their abortion procedure. Approximately, 30-60 mins after study drug administration, the     procedure will be performed.      A sub-study will be completed on 40 women who consent to endometrial sampling and to have     their blood drawn.   "
40433|NCT02756390|"     This research study is evaluating the effectiveness of a 3-session behavioral intervention     for insomnia in cancer survivors. This is a behavioral intervention study, and no medications     are involved.   "
40434|NCT02756377|"     Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with     gingivitis as compared to non-alcoholic chlorhexidine mouth wash.      Methods & Material: Twenty-four subjects, without systemic diseases, with plaque-induced     gingivitis will be selected for this study. The patients were treated with scaling and root     planing at the baseline; Oral hygiene instructions were given that included brushing twice-     daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2     minutes, these patients were randomly ,equally divided into two groups, Group A: perform     daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetyl pyridinium,     (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day     with 10ml of the chlorhexidine(Kin Laboratories, Spain), On day 0,7,15 and day 21 of each     phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of     each volunteer were measured.   "
40435|NCT02756364|"     The primary purpose of this study is to compare the progression free survival (PFS) of     participants treated with the combination of fulvestrant plus daily MLN0128 and fulvestrant     plus weekly MLN0128 versus participants treated with single-agent fulvestrant.   "
40436|NCT02756351|"     The study is a first step in establishing the safety and efficacy of the CytaCoat technology     when applied to a medical device such as a nasal prong and the clinical data generated will     serve as a basis for continuous studies in clinically significant settings such as the     neonatal care units.   "
40437|NCT02756338|"     The purpose of this study is to evaluate the safety and feasibility of performing the     BioMonitor 2 insertion procedure in an office setting.   "
40438|NCT02756325|"     Infertility-the inability to conceive despite one year of properly timed unprotected     intercourse-is a common problem. Of all types of male factor infertility, non-obstructive     azoospermia may be the most difficult for couples. Importantly, patients with non-obstructive     azoospermia are asked to make difficult decisions in terms of reproductive choice; surgical     attempts at identifying sperm (microdissection testicular sperm extraction) are often offered     to these patients without a guarantee of being able to identify sperm. New methodologies in     terms of evaluation of azoospermic males PRIOR to the couple embarking upon IVF are needed     urgently. The other potential benefit of non-invasive determination of testis function and     spermatogenesis would be the potential targeting of sperm extraction procedures. We     hypothesize that quantitative MRI employing advanced functional metrics will be sensitive to     functional and metabolic differences between subsets of azoospermic cases and will improve     upon current characterization of patients with this condition. Moreover, it is believed that     these techniques will provide complementary information, such that they may be combined in a     synergistic fashion for targeted extraction methodologies.   "
40439|NCT02756312|"     Although bench data and retrospective studies have provided a promising picture of the     possible influence of anesthetic technique on the risk of tumor progression, current evidence     from RCTs is inadequate to show whether the type of anesthetics might influence tumor     progression.There are many thousands of patients with a cancer diagnosis undergoing surgery     every year, and in the context of biological plausibility, it should lead to the urgent     undertaking of RCTs to further evaluate the association between the anesthetic management and     postoperative malignant glioma progression.   "
40440|NCT02756299|"     Obstructive sleep apnea (OSA) is a common disorder with serious complications. Positive     airway pressure (PAP) is the first line treatment of OSA, which eliminates obstructive     events, reduces daytime sleepiness, and improves quality of life, especially in those with     excessive daytime sleepiness. However, despite the benefits of the PAP treatment, overall     acceptance and adherence rates are not fully promising. Less is known regarding the PAP     adherence rates in Turkey. In the current study, the researchers primarily addressed if an     intensified patient education strategy including the polysomnography (PSG) charts viewing     followed by frequent follow-ups would improve the compliance rates at long-term in patients     with OSA.   "
40447|NCT02756195|"     The study objective is to decrease neonatal mortality and morbidity by elucidating the     etiology of system failures during perioperative care.      In Aim 1 the investigators will use a novel event discovery method, based on the construct of     the nonroutine event (NRE), to efficiently capture dysfunctional clinical microsystem     attributes and potentially dangerous conditions. A NRE is defined as any event that is     perceived by care providers or skilled observers as a deviation from optimal care based on     the clinical situation.      In Aim 2, the investigators will perform a comparative analysis of prospectively collected     NRE data to the data collected by conventional event reporting methodologies.      In Aim 3 the investigators will collaborate with the Tennessee Initiative for Perinatal     Quality Care (TIPQC) to conduct practical pilot testing of tools and measures developed and     refined in the first two Aims.      Products from Aims 1 & 2 will include:        1. a taxonomy of NREs and outcomes for perioperative neonates;        2. neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection          tool;        3. comparisons of 5 established event reporting systems, including their rates, costs and          benefits; and        4. a guide to prototype neonatal safety surveillance and risk prediction for hospitals and          NICUs.      Aim 3 will capitalize on TIPQC's robust network of NICUs, neonatologists, and patient-level     outcome data to conduct a pilot implementation evaluation of the methods and tools developed     and refined in Aims 1-2.   "
40448|NCT02756182|"     A comparative study will be conducted and the patient will undergo a conventional urodynamic     study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP)     measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal     pressure (Pabd) will be collected concurrently in the sitting position and at various fill     volumes for the bladder.   "
40449|NCT02756169|"     Investigators propose this study in order to answer the following research question: An     educational intervention and breastfeeding support at postpartum will increase the frequency     and total breastfeeding duration in the intervention group? This is a randomized (with     control and intervention groups) study, open and parallel (1: 1 ratio between study groups)     with 200 pregnant women in the second or third trimester, according to their body mass index     (BMI, kg / m2) with excess weight (BMI> 29 pre-pregnancy weight) and that will address their     pregnancy in the public health services and hospitals belonging to the Health Ministry of 5     districts: Coyoacán, Magdalena Contreras, Tlalpan, Xochimilco and Alvaro Obregón in Mexico     City.      The intervention group and the control group will have the same characteristics for     eligibility.      The main phases to develop the study are PHASE 1. INTERVENTION DESIGN PHASE 2. IMPLEMENTATION     OF THE INTERVENTION. PHASE 3. FOLLOW-UP The intervention will be offered at 3 times: 1)     Educational intervention (a workshop) to pregnant obese women. The workshop will be held by     an International Board Certified Lactation Consultant (IBCLC) to promote exclusive     breastfeeding and to encourage a better breastfeeding performance in accordance with the WHO     recommendations. The workshop will be held at convenient times and will be conducted for     groups of 8 to 10 participants; 2) Immediate breastfeeding support at hospital by an IBCLC     and; 3) The women will be exposed to early telephonic follow-up during the first week of     their children´s life and each month until six months of life. Then, if the breastfeeding     continues, each two months until the first year of their children´s life.      At the first month postpartum, investigators will visit participants at home, both the     control group and the intervention group, for collecting information on breastfeeding     practices, for taking a breast milk sample to estimate its fatty acids content, and a blood     sample (serum) to obtain the C-Reactive Protein. Also, the investigators will take     anthropometric measurements of the children to evaluate their growth (weight, length, and     skinfold thickness). Investigators will ask for breastfeeding practices and diet of the     participants through a 24 hours recall.      The results of this intervention group will be compared with the control group: pregnant     obese women without the educational intervention or telephonic follow-up.   "
40450|NCT02756156|"     Combining interscalene block with infraclavicular block for humerus surgery provides a unique     surgical anaesthesia and postoperative analgesia.   "
40451|NCT02756143|"     Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.   "
40452|NCT02756130|"     This clinical trial is a Phase II, single center, open label, proof-of-concept study     evaluating the efficacy of birinapant in combination with platinum based chemotherapy. This     pilot study is aimed at determining the efficacy of carboplatin and birinapant co-therapy in     treating patients with advanced newly diagnosed or recurrent high grade serous carcinomas.     Only bio-assay positive patients will be enrolled   "
40453|NCT02756117|"     This study aims to assess the effect and breakdown of lysine administration, specifically     examining whether it leads to increased plasma 2-AAA in healthy humans.   "
40454|NCT02756104|"     ALS is a devastative disorder characterized by motor neuron degeneration. Median survival is     3 years after onset, but may vary from a few months to more than 30 years. Various factors     have been suspected to play a role in such a variation, but recently, it has been described     that regulatory T-lymphocytes (T regs) may mediate ALS progression and survival. Vitamin D is     an hormone know to regulated T reg function in vivo and in vitro. It have recently     demonstrated that vitamin D (VD) levels correlated with ALS prognosis. The investigator want     to go further in the study of the immune processes that could modulate prognosis in ALS. This     could allow proposing VD as a potential treatment of ALS in a future trial. More largely,     this could reinforce arguments in favor of an immune intervention to attenuate the severity     of this devastating disorder.   "
40468|NCT02755922|"     Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal     stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft     treatment, improving bone neoformation.The objective was to evaluate the effectiveness of     AMSCs application in mandibular fractures to reduce regeneration time and increase bone     quality.   "
40469|NCT02755909|"     The study aims to investigate the effect of pre-anesthetic education on patients undergoing     cardiac surgery   "
40470|NCT02755896|"     Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600     centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given     every other day (arm 2). Patients will complete treatment in one week. All patients will be     followed a month after the completion of treatment then q6 months for the first year, then     yearly for the next 10 years.   "
40472|NCT02755870|"     This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind,     escalating single- and multiple-dose study to evaluate the safety, tolerability, and     pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to     this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase.     The SAD Phase will be conducted first followed by the MAD phase of the study.   "
40473|NCT02755857|"     This open-labelled, single arm study is a follow-on from Study MPG010 to compare the relative     bioavailability of Lozanoc 65 mg Capsules against Lozanoc 50 mg Capsules and Sporanox 100 mg     Capsules in patients requiring itraconazole anti-fungal prophylaxis.   "
40455|NCT02756091|"     Cervicocerebral artery dissection is a major cause for stroke in young adults. While     knowledge of cervical artery dissection (CeAD) has increased thanks to a number of high     quality studies, knowledge on intracranial artery dissection (IAD) is limited. Due to     treatment and publication bias little is known about the natural history of IAD. Overall, IAD     is assumed to have a more severe course than CeAD, with a more ominous outcome in patients     with subarachnoid hemorrhage (SAH). Furthermore, little information is available on the risk     of recurrent IAD as well as on the risk of recurrent ischemic and haemorrhagic events in     non-Asian patients. Radiological diagnosis of IAD can be challenging given the small size of     intracranial arteries, and the subtle and non-specific radiological signs which tend to     evolve over time. The optimal treatment of IAD is unknown. There are no randomised trials and     only observational studies with relatively small sample sizes are available, thus providing a     very low level of evidence.      Finding the factors that are decisive for outcome and recurrence after intracranial artery     dissection is key to an improved management of this potentially severe disease predominantly     affecting young patients. By using standardised protocols for diagnosis, imaging and     follow-up, the investigators intend to obtain large representative patient samples in order     to fill the gap of evidence.   "
40456|NCT02756078|"     This is a randomized, double-masked dispensing study where subjects will randomized into one     of two lens sequences to wear each of two contact lens types for a 4-week period with each     lens type.   "
40457|NCT02756065|"     Washington University Early Recognition Center is conducting a research study to examine     brain functional connectivity and network patterns in participants with bipolar disorder and     schizophrenia.   "
40458|NCT02756052|"     Recent changes in medical training environments and restrictive work-hour regulations have     greatly impacted trainees, limiting the number of opportunities to gain proficiency in     procedural skills. Reports suggest that medical residents lack confidence in their ability to     perform certain medical procedures, and program directors often do not believe their     residents can operate independently in major procedures. Simulator based task training (SBTT)     has provided a safe and ethically appropriate method of skill acquisition but training     opportunities remain limited. Methods to enhance motor learning during these training     opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an     emerging form of non-invasive brain stimulation that has been shown to improve motor     learning. tDCS has been shown to enhance increasingly complex skill acquisition. The     investigators propose to examine if tDCS can improve the acquisition and retention of     laparoscopic surgical skill. The investigators propose a double blind, sham-controlled     randomized trial applying tDCS during evidence-based SBTT of medical students and surgical     residents, to determine if brain stimulation can enhance training effects and long-term skill     acquisition. Even a modest enhancement carries the potential to transform medicosurgical     skills training.   "
40459|NCT02756039|"     Clinical experience investigation (CEI) is to be conducted to confirm the following to     characterise safety and efficacy of Tagrisso Tablets in actual clinical use.        1. Incidence of adverse drug reactions (ADRs) in actual clinical use        2. Factors which may affect safety and efficacy of the product (especially analysis of the          incidence and risk factors of interstitial lung disease (ILD) events)        3. Information of ADRs not expected from Precautions for Use of the package insert in          Japan   "
40460|NCT02756026|"     The purpose of the study is to establish a protocol for collecting representative samples of     breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN)     supplementation on milk MN concentrations. The investigators will determine which     breastfeeding episode during the 24 hour period best represents the maternal status; and     within the episode whether fore, mid or hind milk samples be collected in future studies.   "
40461|NCT02756013|"     The purpose of this study is to evaluate the side effects and effectiveness of giving     standard paclitaxel chemotherapy in doses based on actual body surface area in combination     with standard dosed carboplatin chemotherapy for overweight women.   "
40462|NCT02756000|"     The study will compare clinical outcomes between complete revascularization during     hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days     and intervention based on outpatient non-invasive ischemia testing in patients with     multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial     infarction.   "
40463|NCT02755987|"     This is an expanded access study with ANG1005 treatment for two individual patients from     Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III     Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with     Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.   "
40464|NCT02755974|"     The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995     and designed to study COPD exacerbations and their impact on health-status and disease     progression.   "
40465|NCT02755961|"     Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And     most phosphate in human is derived from the food. The purpose of this study is to evaluate     the efficacy of nutritional consultation and education on phosphate binder among dialysis     patients.   "
40466|NCT02755948|"     Respiratory viruses including influenza and respiratory syncytial virus (RSV) are among the     most important causes of severe disease globally, infecting everyone repeatedly throughout     life. Understanding of how to prevent infection is incomplete but boosting immunity with     vaccines remains the best strategy. T cells have been shown in animals to be essential for     clearing respiratory viral infection and are likely to be helpful if stimulated by vaccines.     However, where these cells originate from and how they develop in the human lung are still     unclear. The investigators will inoculate volunteers with influenza or RSV to examine the     relationship between T cells in their blood and lungs and the outcome of infection. By     tracking these specialised cells, the investigators aim to develop a better understanding of     how they are generated in order to harness them with future vaccines.   "
40467|NCT02755935|"     To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532     electrode array.   "
40471|NCT02755883|"     This randomized controlled trial will evaluate, among 54 stage early stage lung cancer     patients, whether a behavioral intervention versus an educational Control group results in     improved function at 6-months.   "
40474|NCT02755844|"     Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025 deaths/     year). The 5-year overall survivals of patients at diagnosis with locally advanced and     metastatic carcinomas are about 50% and 15% respectively. Beyond first line treatment with     platinum-based chemotherapy, there is lack of effective drug in this disease, which explains     the poor prognosis of patients.      The prognosis of metastatic endometrial cancer patients is poor, and few drugs have been     shown to be effective beyond first chemotherapy line.      Endometrial carcinomas are characterized by frequent alterations of PI3K-AKT-mTor; IGF1R and     of DNA repair pathways. Phosphatase and tensin homologue (PTEN)-phosphoinositide 3-kinase     (PI3K)-mammalian target of rapamycin (mTor) and DNA repair pathways interact, and inhibition     of PI3K-AKT-mTor signaling pathway may alter DNA damage repair.      Metronomic cyclophosphamide regimen may increase the anti-proliferative effects of olaparib     because it is an alkylating agent, and it exerts anti-angiogenic effects, with a favorable     toxicity profile.      Metformin may increase the anti-proliferative effects of olaparib because it downregulates     IGF1R and PI3K-AKT-mTor pathways, with no additive toxicity.   "
40475|NCT02755831|"     Prospective, randomized controlled trial. Pregnant women in early pregnancy will be     randomized to either the Sleep Study + CPAP group (n = 180) or to a Standard Prenatal Care     group (n = 180). Subjects in the Sleep Study + CPAP group will complete a sleep study     (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the AHI ≥5 as indicated, in     early and late pregnancy, whereas the other group will receive standard prenatal care. All     subjects will complete a sleep study again at 12 weeks postpartum.   "
40476|NCT02755818|"     Approximately 20 million people in the United States have some form of kidney failure. People     with kidney failure have an increased chance of having low levels of high density lipid     (HDL), so called good cholesterol. Patients who are overweight or obese also have low     levels of HDL. The investigators are trying to find out whether causes of low HDL are the     same in people who are overweight and in patients with kidney failure so that in the future     doctors can better treat low HDL cholesterol levels. People with low levels of HDL are more     likely to have heart attacks and strokes and are more likely to lose kidney function. This     study hope to learn more about how kidney failure causes low HDL cholesterol levels.   "
40477|NCT02755805|"     Cognitive impairments occur frequently after stroke, and are associated with significant     long-term activities of daily living (ADL) disability and poor quality of life. This research     study will undertake an innovative approach addressing cognitive impairments, by examining a     new patient-centered functionally-relevant rehabilitation intervention that teaches     individuals with cognitive impairments to manage their deficits to reduce ADL disability.   "
40478|NCT02755792|"     This study is aimed to investigate the efficacy of an 12-week Chinese calligraphy training     program for enhancing cognitive and emotional functions of older adults with mild cognitive     impairment. Participants are tested with several cognitive tests and electroencephalography     (EEG), psycho-physical parameters and brain activities are recorded. Results are compared at     pre-intervention, post-intervention, and 6-month post-intervention to provide evidence of     benefits of Chinese calligraphy practice.   "
40479|NCT02755779|"     Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is     common to discover Incidental breast lesions on chest CT.      The goal of this study is to investigate the incidence and appearance of incidentally     discovered breast masses on chest CT.   "
40480|NCT02755766|"     While studies have shown that better outcomes are associated with brace wear compliance in     the scoliosis and clubfoot populations, compliance rates are still poor. Reasons identified     by patients, parents and research for not complying with prescribed brace wear include the     inconvenience or irritability of the child when in the brace in the case of clubfeet, and     fear of looking different from peers, clothes not fitting properly, or discomfort in the case     of scoliosis. While reasons for noncompliance are many and can be complex, there has been     some research to indicate that personality traits may play a role in brace wear compliance.      The primary purpose of the proposed study is to determine if personality traits are related     to compliance patterns for individuals undergoing brace treatment for AIS or Clubfeet.   "
40481|NCT02755753|"     The purpose of this study is to evaluate whether Rebamipide facilitate the healing of     inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).   "
40482|NCT02755740|"     This project aims to promote quitting, and reduction for those who do not want to quit, among     female smokers through training female youth as smoking cessation and reduction ambassadors     (SCRA). The objectives are to:        1. Promote age and gender-specific smoking cessation and reduction to the female population        2. Deliver a smoking cessation and reduction ambassador training workshop to equip and          empower female youth with the knowledge on the adverse effects of smoking on female          smokers and the skills in smoking cessation and reduction and in raising public          awareness of the harmful effects of smoking on female smokers.        3. Have the trained female youth to deliver a brief advice (AWARD) to female smokers to          help them to quit or reduce smoking and refer them to the female-specific smoking          cessation hotline or the Department of Health Quitline for further assistance if needed.   "
40500|NCT02755493|"     This project proposes to both develop and test adaptive automation countermeasures for the     effects of stressors such as sleep deprivation (SD) on human performance related to robotic     tasks, and investigate the relationship between human trust and appropriate use of these     countermeasures.   "
40547|NCT02754869|"     This project involves the development, validation and application of a novel test using MRI     to assess gastrointestinal motility a vital process that mixes the contents of our digestive     tract. This process frequently becomes deranged in conditions like chronic constipation,     Parkinson's and Crohn's disease.   "
40551|NCT02754817|"     This study is conducted in Europe. The aim of the study is to investigate the effectiveness     of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2     diabetes mellitus.   "
40552|NCT02754804|"     Vascular claudication is a common cause of functional limitation. This painful condition is a     source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient     leading gradually to a state accented inactivity. The characterization of the claudication as     it results from a proximal or distal ischemia has never carried out. Investigators will     analyze dynamic pedometer parameter throughout walking tests in PAD patients with     claudication   "
40483|NCT02755727|"     Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with     repetitive use of the forearm extensor muscles. Though often self-limiting in nature there     are a proportion of patients who fail to respond to conservative treatments such as rest,     activity modification, physiotherapy and the use of a brace. Though previously a common     treatment modality steroid injections have been shown to be detrimental in the longer term.     Present practice is to offer those patients who do not respond to conservative treatment     surgical debridement. Though often effective this is an invasive procedure. Platelet rich     plasma injections may offer a viable alternative in chronic cases however there is no     systematic evidence of its efficacy.      Methods 12 patients, diagnosed with chronic lateral epicondylar tendinopathy, will be     randomly assigned to receive either open surgical debridement or platelet rich plasma     injections. Following treatment, they will be followed up at intervals of 6 weeks and 3, 6     and 12 months. The outcome of each treatment will be assessed using validated outcome scoring     measures specifically designed for upper limb pathology. The results of this pilot study will     be used to construct a larger randomised control trial.   "
40484|NCT02755714|"     Exercise Induced Laryngeal Obstruction (EILO) is a condition not uncommon in otherwise     healthy young people. EILO is caused by posteromedial collapse of supraglottic structures or     medialization of the vocal folds, or both, during high intensity exercise. There are     currently no treatments available that is properly evidence based. However, case reports     suggest a possible effect from the asthma drug Ipratropium Bromide (Atrovent®). The current     project is an open label pilot study, aiming to test if Atrovent can influence the occurence     of EILO, either postponing the onset during exercise or fully prevent the condition to occur.   "
40485|NCT02755701|"     To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic     patients with ascites.   "
40486|NCT02755688|"     Atrial fibrillation (AF) is the most common heart arrhythmia. Many people do not have     symptoms and are not aware they have AF. Others may feel dizzy, short of breath, feel very     tired and become aware of a fast and irregular heart beat (palpitations). The main     complication of AF is an increased risk of stroke and incidence of heart failure. There are     two key aspects of treatment for AF. The first is protection from stroke, treated with oral     anticoagulants. Treatment of AF is either by controlling the rate (frequency of contraction)     or controlling the rhythm (restoring regular contraction). Rate-control is generally employed     first with an intent to reduce the rate at which the lower pumping chambers contract and     improve their efficiency. Appropriate medication is used and with this treatment strategy it     is accepted that AF will be present as the long term heart rhythm. If symptoms persist     despite medication the preferred strategy is to restore sinus rhythm (SR) and regular     contraction in all pumping chambers of the heart. This can be done with electric shock     treatment (DC cardioversion) together with long-term tablet medication, or by a more     definitive 'cauterisation' therapy (catheter or thoracoscopic surgical ablation). In this     study the investigators will study patients with symptomatic long standing persistent AF     (continuous AF for more than 1 year) who have tried and failed drug and/or electrical     therapy. At present the investigators do not know what the best ablation technique is for     treating symptomatic, long-standing persistent AF (LSPAF). Catheter ablation (CA) is the most     widely available invasive treatment available for AF. Thorocoscopic surgical ablation (SA) is     not widely available but our hospitals have the expertise to conduct this procedure. CA has     been shown to achieve modest degrees of success in restoring normal SR with the caveat that     most patients do require 'multiple' procedures (usually two or three). SA offers patients an     alternative choice of therapy with a keyhole surgical thoracoscopic) approach. It may have a     higher single procedure success rate although there is the potential for greater complication     rates. The investigators aim to examine this in detail to help us understand which approach     might be better for managing LSPAF.   "
40487|NCT02755675|"     uPAR PET/CT as a prognostic marker in non-small cell lung cancer.   "
40488|NCT02755662|"     ESTAMPS is a randomized clinical trial with a crossover design:      Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs     (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway     volume      secondary objectives: To evaluate the maximal mandibular propulsion according to the type of     MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact     of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on     mandibular positioning   "
40489|NCT02755649|"     The main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab     compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult     patients with severe AD who are not adequately controlled with, or are intolerant to, oral     Cyclosporine A (CSA), or when this treatment is currently not medically advisable.      The secondary objective is to assess the safety and tolerability of 2 dose regimens of     dupilumab compared to placebo, administered with concomitant TCS, in adult patients with     severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when     this treatment is currently not medically advisable.   "
40490|NCT02755636|"     Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and     premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools     designed to assist patients and primary care providers (PCPs) in applying evidence-based     principles of health behavior change to reduce four cancer risk behaviors—cigarette smoking,     risky drinking, noncompliance with national guidelines for physical activity, and overweight     and obesity—and depression among at-risk patients. The intervention is based on the     Transtheoretical Model of Behavior Change (TTM, the stage model) and includes     computer-tailored interventions and text messages for patients and a clinical dashboard for     providers. The efficacy of the intervention will be assessed in a cluster-randomized trial     involving 780 patients recruited from 12 federally qualified health centers randomly assigned     to intervention or usual care.   "
40501|NCT02755480|"     Patients with bone marrow cancer are more susceptible to chest infections than healthy     adults; marrow ablation treatment further compromises their immune status and increases the     risk of fungal opportunistic infection, which is associated with a high fatality rate.     Therefore, it is critical to achieve early and accurate diagnosis of fungal infection when     these patients become febrile. At the Mount Sinai Hospital (MSH) and the University Health     Network (UHN), the standard of care (SOC) to exclude a chest infection in immunocompromised     (IC) patients is chest computed tomography (CT) using low dose CT (LDCTT).   "
40502|NCT02755467|"     To evaluate the safety and effectiveness of the laser treatment for the treatment of spider     angiomas.   "
40545|NCT02754895|"     This trial is part of a multi-phase study to develop and test positive psychology (PP)     interventions in patients hospitalized for an acute coronary syndrome (ACS).Using a factorial     design, the investigators will: (a) assess the optimal frequency of exercise completion, (b)     determine the utility of 'booster sessions' after an initial 8-week intervention, and (c)     determine the relative merits of utilizing PP exercises alone versus an intervention     combining PP with motivational interviewing (MI).   "
40491|NCT02755623|"     The potential of non-invasive Transcranial Magnetic Stimulation (TMS) as a therapeutic tool     for improving schizophrenic symptoms, in particular resistant hallucinations, has been     increasingly studied over the past decades. Several studies have demonstrated that     low-frequency patterns of repetitive TMS (rTMS) applied over the left Temporoparietal     Junction (TPJ), which are known to decrease local activity, significantly reduced auditory     verbal hallucinations in schizophrenic patients. In spite of highly promising results, a high     level of inter-individual variability in the responses to non-invasive brain stimulation     treatments, and the fact that rTMS may prove ineffective in some patients, keep spurring     controversy about the efficacy of these approaches (as currently performed), as well as about     how to increase its efficacy and consistency. Accordingly, the objectives of this project are     to better understand the impact of rTMS on the brains of patients with resistant auditory     hallucinations, and to use this information not only to better understand this condition but     to develop more efficient and consistent therapies. Thus, in this study, the investigators     focus more specifically on resistant auditory hallucinations in schizophrenia, which is a     common symptom in schizophrenic patients, and can be treated by rTMS. The investigators     hypothesize that there is a baseline difference in anatomical and/or functional connectivity     between responder and non-responder patients who are treated with rTMS. Therefore, our     project will aim to determine some anatomical and functional connectivity markers of response     to rTMS treatment in patients with schizophrenia   "
40492|NCT02755610|"     Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal     Disease (ESRD) patients under the PD First policy of the Universal Coverage (UC) scheme.     The increased demand has resulted in not only supply chain logistical problems, but also     product quality concerns. Peritonitis, the main complication and main cause of failure in     Continuous Ambulatory Peritoneal Dialysis (CAPD) patients, could be caused by product defect.     This cluster randomized trial will be conducted in participating Peritoneal Dialysis Outcomes     and Practice Patterns Study (PDOPPS) centers in Thailand to assess if a check list     intervention could reduce peritonitis rate and increase the number of product defect report.   "
40494|NCT02755584|"     Background:      Cellular senescence is the aging of cells. It is a complex process that may be connected with     aging and age-related diseases. It is unknown if these cells appear around wound sites in     humans a few days after skin injury and if there are differences in young and old     individuals. This study is being done to look at how cells in your body respond to small skin     wounds. This information may help treat age-related diseases.      Objective:      To study how cells in the body respond to small skin wounds.      Eligibility:      Healthy adults ages 20-39 or 70+      Design:      Participants will be screened with medical history, physical exam, and blood sample. They     will fast before the screening visit. Women will have a urine pregnancy test.      Participants will have 3 study visits over about 3 weeks.      Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine     test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two     small pieces of skin will be removed. They will keep the area covered until the next visit.      Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured     and photographed.   "
40495|NCT02755558|"     In this study, the investigators varied both the energy density and portion size of milk     served with a meal commonly consumed by preschool children. The milk used in this study is     commercially available and reflects typical variations in energy density. The primary aim of     the study is to investigate the independent and combined effects of milk energy density and     portion size on preschool children's intake of the milk and the simultaneously served meal.     The effect of milk energy density and portion size on children's total energy intake at the     meal will also be evaluated.   "
40496|NCT02755545|"     The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of     use in adult men and women with mild to moderate facial acne, at least 5 inflammatory     lesions, and at least 10 - 100 non-inflammatory lesions.      Objective:        1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week          2, week 6, week 12, and week 24 as compared to baseline and compare between treatments        2. To characterize the effectiveness of the acne treatment in Investigator's Global          Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to          baseline and compare between treatments        3. To characterize the effect of the acne treatment in clinical grading of efficacy          parameters through digital images at week 6, week 12, and week 24 as compared to          baseline and compare between treatments        4. To characterize the effect of the acne treatment in subject self-assessment          questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to          baseline and compare between treatments   "
40497|NCT02755532|"     Introduction: The risk of systemic toxicity when using bupivacaine is a persistent problem,     making its pharmacokinetic study crucial to the safety of regional anesthesia (RA). Little     evidence exists regarding the effect of different concentrations of this drug on peak plasma     levels. The present study compares two bupivacaine concentrations to establish how the     concentration and exchange area affect the peak plasma level of this drug during axillary     brachial plexus block. Latency and postoperative analgesia periods were also compared.      Methods: 32 patients were randomly assigned to two groups. In the 0.25% group, 10 ml of 0.25%     bupivacaine was injected per nerve; in the 0.5% group, 5 ml of 0.5% bupivacaine was injected     per nerve. Peripheral blood samples were collected every 15 min during the first hour and     every 30 min during the second hour to establish serum level dosage. High-performance liquid     chromatography coupled with mass spectrometry was used for the analysis.   "
40498|NCT02755519|"     To optimize the confirmatory tests for primary aldosteronism.   "
40499|NCT02755506|"     The study aims to evaluate the role of endobronchial ultrasound elastography in     differentiated diagnosis of benign and malignant thoracic lesions   "
40517|NCT02755259|"     To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with     pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation     (RHC).   "
40587|NCT02754349|"     This study aims to evaluate the reliability of measurements of arterial stiffness (pulse wave     velocity (PWV), pulse wave contour analysis (PWA), central augmentation index (AIx) and pulse     pressure (PP)) in atrial fibrillation (AF). For this purpose 30 AF patients scheduled for     electrical cardioversion will be included. PWV and PWA measurements will be carried out     before and after cardioversion.   "
40503|NCT02755454|"     The goal of this study is to determine specific perfusion patterns for radiation induced lung     changes and residual/recurrent lung malignancies in patients treated with stereotactic body     radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent     lung cancers. Currently CT is often unable to make a clear differentiation between benign and     malignant changes in the lung after SBRT treatment necessitating additional wait time to     perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want     to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to     obtain perfusion values of post treatment lung changes and lung tumours. The investigators'     hypothesis is that CT perfusion values will help differentiate benign post radiation changes     from residual/recurrent tumour in the lung with higher confidence and may help avoid     unnecessary delays in cancer treatment.   "
40504|NCT02755441|"     All incident cases of idiopathic pulmonary fibrosis (IPF) in Denmark will be offered     inclusion during a 2 year period and followed up for at least 1 year with measurements of     serum biomarkers and measurements of disease progression.   "
40505|NCT02755428|"     This project intends to transplant human embryonic stem cells derived retinal pigment     epitheliums into subretinal space of patients to treat dry age-related macular     degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat     dry AMD.   "
40506|NCT02755415|"     Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted     gait training system for acute stroke survivors. It is anticipated that robot-assisted gait     rehabilitation will achieve significantly better gait and quality of life outcomes than the     standing table rehabilitation.   "
40507|NCT02755402|"     Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but     underrepresented among those who are treated, despite many studies showing that treatment is     feasible and effective in this population.      The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is     a potential occasion for disengagement and loss to follow-up. This is especially true with     hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial     situation can change rapidly.      By using new technologies that can quickly provide clinical results, like Xpert HCV Viral     Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a     patient needs treatment rapidly or not on the day of the initial visit.      The aim of this study is to explore whether an accelerated pre-treatment evaluation can     result in an improved linkage-to-care (defined as linkage to health care, addiction or social     services) and, eventually, linkage-to-treatment among PWID.   "
40508|NCT02755389|"     This is a randomized clinical trial investigating the utility of apneic oxygenation via nasal     cannulae in the post-induction setting for the purpose of prolonging the safe apneic time.     Three groups will be compared, a control group at 0 L/min, a 15 L/min and a 60 L/min group.     The primary outcome will be the difference in the partial pressure of oxygen in arterial     blood (PaO2) between groups throughout the nine-minute apneic period.   "
40509|NCT02755376|"     Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL)     injury using stem cell.   "
40510|NCT02755363|"     The purpose of this study is to determine whether the selected osteopathic techniques have a     positive impact on the residual volume decrease in patients with chronic obstructive     pulmonary disease with severe and very severe airflow limitation in comparison to the manual     therapy not aimed to decrease hyperinflation (placebo).   "
40511|NCT02755350|"     Daily oral PrEP will be delivered to men who have sex with men (MSM), female sex workers     (FSWs) and young women (YW) as part of a defined package of HIV combination prevention     intervention for 12 months in 5 sites in Kenya. The project will assess adherence, adverse     events, side effects, user satisfaction, cost, facility preparedness and provider     competencies. PrEP eligibility and screening tools for MSM, YW and FSWs will be piloted and     validated. Pregnant women will be enrolled in a sub-group and followed through 12 months     post- partum to measure mother and infant outcomes that include health status, birth     outcomes, birth defects, risk behavior and PrEP adverse effects. With lessons from initial     PrEP studies in West and Central Africa, this project will apply good participatory practice     guidelines through 1) continuous engagement with communities of FSWs, YW and MSM and 2)     development and use of a communication engagement and advocacy strategy that will provide     correct information, address attitudes and concerns whilst increasing demand for PrEP uptake.     The actual cost of delivering HIV combination prevention which includes PrEP will also be     assessed and cost effectiveness modeled.   "
40512|NCT02755337|"     To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome     after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General     Hospital, Surabaya, Indonesia.   "
40513|NCT02755324|"     Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma     mansoni cercariae until 10 volunteers are found infected.   "
40514|NCT02755311|"     The role of transarterial chemoembolization (TACE) as the standard therapy for     intermediate-stage hepatocellular carcinoma (HCC) is being challenged by increasing studies     which showed that liver resection (LR) is a safe and feasible procedure with better survival     outcomes than TACE does.      In light of this, the investigators have constructed a Markov model to simulate comparing LR     and TACE in the treatment of intermediate-stage HCC. The results suggested that LR may     provide survival benefit over TACE for the treatment of intermediate-stage HCC in cirrhotic     patients. However, validating the simulated result by a study with higher quality (e.g.     prospective clinical trial) would be of great value in providing a more convincing finding.     Therefore, based on the established Markov model, the investigators aimed to prospectively     compare the treatment efficacy and safety of LR with TACE for consecutive patients with     intermediate-stage HCC.   "
40515|NCT02755298|"     The study seeks primarily to determine the chronic clinical effect of AZA on exercise     capacity (6MWD) compared to placebo.   "
40516|NCT02755272|"     The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy     (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic     triple negative breast cancer.      Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells.     Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and     metastatic non-small cell lung cancer. However, it has not been approved as a treatment for     breast cancer.   "
40522|NCT02755194|"     Some medications taken by the breastfeeding women are excreted into milk, posing a potential     risk of toxicity to the infant. The first line of evidence required for toxicity risk     assessment is prediction of drug levels in milk. However, pharmacokinetic (PK) information of     drug excretion into milk is largely lacking, or limited to data from case reports. This makes     it difficult to provide population-level prediction of drug levels in milk. The lack of data     on this topic jeopardizes not only maternal adherence to drug therapy during breastfeeding     but also establishment of breastfeeding, even if the drug is considered safe during nursing.     Clearly, this clinical problem in drug safety is an important women's health issue, affecting     both mother and infant. Drugs in Lactation Analysis Consortium (DLAC) is a drug-in-milk     monitoring network, which is designed as a platform for efficient collection of patient milk     samples in a real world setting to generate population predictions of drug excretion levels     into human milk.   "
40523|NCT02755181|"     This study aims to use resting-state and task based functional Magnetic Resonance Imaging     (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline     personality disorder.   "
40524|NCT02755168|"     Caesarean section is one the most common operations worldwide, its rates are globally     increasing. A multitude of efforts had been done aiming at reduction of Caesarean section     related maternal morbidities; most of them are related to technical modifications of how to     open and how to close the abdominal and uterine incisions . The comparative studies of blunt     versus sharp extension of the uterine incision showed a reduction of the incidence of     unintended extension from 8.8% to 4.8% .      The vulnerability of the lower uterine segment for tears are related to stage of labor. The     frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in     first and second stages of labor respectively.      The original techniques of fetal head extraction entail the introduction of the obstetricians     hand or other instruments into the lower uterine segment . This puts the lower uterine     segment at risk of damage and incision extensions with its consequences of increased blood     loss, increased operative time, infection adhesions and blood transfusion. Adherence to the     available the generated good quality evidence bases practice in Caesarean section is     anticipated to decease such morbidities.      The idea of the present technique was derived from the fact that during vaginal delivery the     main task of obstetrician is to support the perineum while the fetal head extends to get out     through birth canal.   "
40525|NCT02755155|"     Primary purpose : mortality at Day 28      Secondary purposes :        -  Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care          Unit (ICU)        -  Duration of increasing doses of norepinephrine infusion to maintain target mean arterial          pressure        -  Number of care-related infections within ICU   "
40526|NCT02755142|"     This study is planned to detect a dose-efficacy relationship between the chosen dose levels     of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with     newly diagnosed malignant glioma.   "
40527|NCT02755129|"     The aim of this study is to evaluate sit-stand phases and gait speed detection using an     externally worn Reveal LINQTM compared to an external reference (3D accelerometer, and/or the     Computer Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands   "
40528|NCT02755116|"     Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic     techniques have improved and pressure to reduce health-care costs has increased. While there     are many benefits to recovering from surgery within the home, a significant disadvantage is     the lack of rapid access to a healthcare provider when postoperative complications occur.     Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent     studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after     ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years,     history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in     the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in     the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative     ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to     prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the     incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel     strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be     administered preoperatively. This study will evaluate whether there is a difference in the     incidence and severity of PDNV between patients who receive oral olanzapine versus placebo     prior to general anesthesia for ambulatory gynecologic surgery.   "
40529|NCT02755103|"     The current study will modify an already existing therapy for individuals with substance use     disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance use     disorders (SUD) treatment who suffer with both PTSD and SUD. Mindfulness meditation has been     shown to help individuals to cope with stress and regulate emotions. Through meditation     practice women will experience less distress related to PTSD symptoms and reduced substance     use in response to emotional triggers. Women enrolled in intensive SUD treatment at a     community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based     Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone. The MBRP     group sessions will replace 90 minutes of TAU group therapy. Measures of feasibility of     implementation, acceptance and adherence will be obtained. Preliminary efficacy for substance     use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months'     follow-up.   "
40530|NCT02755090|"     This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of     inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl     and midazolam, for pain management in adult women having a pregnancy termination procedure     between 12 and 16 weeks gestational age.   "
40531|NCT02755077|"     Upper airway obstruction commonly occurs after induction of general anesthesia. The aim of     this study is to determine if head rotation improves the efficiency of mask ventilation of     anesthetized apneic adults.   "
40532|NCT02755064|"     With this study, the investigators hoped to learn if the rate at which food empties from the     stomach affects blood sugar values. Using data from this study, we hope to improve our     ability to control blood sugars in individuals with type 1 diabetes mellitus.   "
40533|NCT02755051|"     Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8     sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD     (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be     assessed at the end of session 3. Treatment enactment will be assessed throughout treatment,     post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent     sleep) will be collected at baseline, post-treatment, and 1-month follow-up.      Study Flow:      Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16     --->Follow-up (wk 17-18)      Session:        1. Sleep education        2. Sleep scheduling, limit setting, and stimulus control        3. Teaching relaxation strategies and other adaptive coping skills        4. Parenting strategies (differential attention, rewards, consequences)        5. Identification of maladaptive & adaptive cognitions        6. Problem solving & communication skills        7. Sleep restriction; bright light to change circadian rhythms        8. Review gains and plan for long-term maintenance   "
40534|NCT02755038|"     The investigators hypothesis is that we can determine estrogen and progesterone levels in the     hair by using the immune method and we can show a significant difference in the levels of     these hormones in both groups of women: pre- and postmenopausal women. If indeed it would     then be possible in future to carry out research that can find a relationship between the     levels of these hormones and various diseases   "
40535|NCT02755025|"     The SOFA score is a severity of illness and prognostic score used in the ICU. It has also     recently been adopted as part of the definition of sepsis. This study will prospectively     evaluate the usability of automated SOFA scoring for ICU patients within an electronic     patient monitoring dashboard. It will also assess for changes in physician ordering (volume     and types of orders) after automatic scoring is implemented.   "
40536|NCT02755012|"     This study takes place in rural Mam-Mayan communities of Guatemala characterized by high     rates of childhood stunting. It aims to characterize women's exposure to nutrition, infection     and psychosocial stressors vs. resilience factors, to evaluate the cumulative impact of     maternal-level factors (nutritional, infectious, psychosocial), social factors (autonomy,     social support, domestic violence), and household factors (socioeconomic status, food     security) on early infant growth, and to evaluate whether maternal cortisol may be a mediator     in the vertical transmission of stress.   "
40537|NCT02754999|"     In this open-label study, eligible and consenting adult patients admitted to the hospital for     critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL,     but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one     or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of     the acute anemic episode.   "
40538|NCT02754986|"     This study assesses autonomic nervous system function by power spectral analysis of RR     interval dynamics in ultrafiltration subjects without blood pressure variation.   "
40539|NCT02754973|"     Background: Despite the evidence that regular physical activity can have beneficial effects     on the physical and psychological well-being of cancer patients, a review of the literature     reveals that a majority of young cancer patients fail to attain the same levels of physical     activity that they had before contracting the disease. There is scientific evidence that     physical inactivity induces muscle catabolism and atrophy and cardiovascular diseases, which     may lead to a further increase in fatigue and a decrease in the functional capacity of cancer     patients. Empirical evidence is needed to explore an appropriate strategy for promoting     physical activity in such patients.      Purposes: To examine the effectiveness of an integrated experiential training program with     coaching by healthcare professionals in promoting regular physical activity, reducing fatigue     and enhancing quality of life among Hong Kong Chinese childhood cancer patients.      Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated     post-test, within and between subjects design will be conducted. Recruitment of subjects will     be carried out in a paediatric oncology ward of a Hong Kong acute care hospital.      Intervention: Participants in the experimental group will join an integrated experiential     training program with coaching by healthcare professionals, which contains 28 home visits by     a designated nursing student as a coach for a 6-month period. Those in the placebo control     group will receive an amount of time and attention (home visits by research assistants) that     mimics that received by the experimental group.   "
40540|NCT02754960|"     Background: Repeated bleeding from gastrointestinal vascular malformations remains to be a     major therapeutic challenge.      Methods: The investigators performed a randomised, double-blind, placebo-controlled, single     centre study to assess the long-term efficacy and safety of thalidomide 100mg qn p.o. or     placebo 100 mg qn p.o. administration for 4 months in subjects with recurrent     gastrointestinal bleeding due to vascular malformations. Patients with at least six episodes     of bleeding in the prior year due to vascular malformation were randomly grouped, prescribed     a four-month regimen of either 100mg of thalidomide or 100 mg of placebo orally one time     daily, and monitored for at least one year. The primary end point was defined as the patients     whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was defined based on     a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any     visit after treatment. Secondary outcomes included the changes from baseline in participants     dependent on blood transfusions and transfused packed red cell units, bleeding episodes,     bleeding durations, and hemoglobin levels at 12 months. Statistical significance was defined     at P < 0.05.   "
40541|NCT02754947|"     The goal of this study was to identify the etiology of events and demographics of patients     that experience complications requiring activation of the Rapid Response Team (RRT) during     the first 24 h following anesthetic care.   "
40542|NCT02754934|"     This study evaluates, if the movement of the cervical spine, assessed via a specific     questionnaire by the patient, is a valid and reliable tool and could be used in daily     clinical routine.   "
40543|NCT02754921|"     The aim of this study is to compare Ultra-perc single stage dilator technique with Ciaglia     Blue Dolphin ballon dilatation technique for intubated unweanable ICU patients with respect     to procedure difficulties and complications.   "
40544|NCT02754908|"     This study aims to examine the effects of musical training on improving the neurocognitive     function and psychological well-being of children surviving brain tumours. Half of the     participants will receive weekly 45-minute lessons on musical training for one year (52     weeks) while the other half are the placebo controls.   "
40553|NCT02754791|"     Bloodstream infections cause significant morbidity and mortality and their prompt     identification is an essential part of modern medicine. False positive results in blood     cultures are primarily due to contaminants. It has been estimated that up to 50% of positive     blood cultures represent contamination. These false positive cultures, at the microbiological     laboratory level, require significant additional resources for workup. Additionally, they     result in unnecessary antibiotic treatment and hospitalization days, causing needless harm to     patients. Various methods have been implemented in order to reduce blood culture     contaminants, including modifying the solution used for sterilizing the skin and feedback on     contamination rates. However, it has been shown that the bacteria which colonize the human     skin are not only on the surface but in fact colonize deeper surfaces as well. The SteriPath     device diverts the initial 1-2 ml blood so as to remove any potential skin plug with     contaminants. Thus, the principle object of this study is the determination of the rate of     contamination of blood culture taken prior to initiating intervention versus the rate of     contamination using three interventions: Monthly feedback via departmental report card, a     chlorhexidine plus alcohol wipe and the SteriPath device. Secondary objectives will include     ease of use of the wipes and the SteriPath device and an estimate of the sensitivity of     SteriPath device use to true bacteremia. If the various interventions will be shown to reduce     contamination, researchers will also attempt to estimate the financial effects of those     reductions, comparing intervention cost to estimated savings related to reduced     contamination.   "
40554|NCT02754778|"     Evaluation of practicability in survey and test procedures and of successful implementation     of complex interventions - feasibility analysis based on a pilot study: Influence of     conditional workout postpartum on arterial stiffness among women with status after     preeclampsia, superimposed preeclampsia or HELLP-syndrome   "
40556|NCT02754752|"     The goal of this clinical research study is to compare 3 types of interventions (involving     electro-acupuncture and standard care) that are given to women with chronic post-surgical     pain after a mastectomy. Researchers want to find out which intervention may be most     effective in relieving breast pain. The safety of these 3 interventions will also be studied.   "
40557|NCT02754739|"     An increased risk of incident diabetes with statin therapy have been reported in several     studies. However, it is not recommended to limit the use of statin for this reason since the     absolute risk increase was small, and the cardiovascular event rate reduction with statins     overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin     may have different effect on the development of incident diabetes. In the West of Scotland     Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by     30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the     improvement in insulin sensitivity, has been reported. In this clinical trial, the     investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin     secretion, glycemic control, and adiponectin level in participants with prediabetes or early     diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.   "
40558|NCT02754726|"     The purpose of this study is to find out if the study drugs nivolumab, albumin- bound     paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective     when combined to treat advanced pancreatic cancer.   "
40559|NCT02754713|"     The study will aim at investigating novel plasma or imaging biomarkers in patients with acute     pericarditis. All participants will be treated according to established clinical     recommendations for the diagnosis and treatment of acute pericarditis.      Study participants will undergo blood sampling for measurements of plasma biomarkers     potentially involved in the pathogenesis of acute pericarditis. Imaging datasets from     available imaging tests will be used to quantify imaging biomarkers. Patients will be     followed up prospectively for up to 18 months. The prognostic value of plasma and/or imaging     biomarkers for development of complications such as atrial fibrillation, pericarditis     recurrences, constrictive pericarditis and/or the need to switch to 2nd line treatment will     be sought.   "
40560|NCT02754700|"     This study will identify the most optimal, focused approach for biofeedback in adolescent     females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized,     pre/post-testing design will be used to identify biofeedback training effects. The     investigators will also determine the effects of hip strategy on retention of decreased knee     abduction load with focused biofeedback. A six-month follow-up design will be used to test     retention of real-time biofeedback intervention.   "
40561|NCT02754687|"     The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone     Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.   "
40562|NCT02754674|"     1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome          using two anterior cruciate ligament reconstruction techniques ; transportal technique          with flexible reamer and single bundle outside in technique with remnant preservation.        2. Subjects: anterior cruciate ligament (ACL) injury 66 patients             -  Double bundle transportal technique with flexible reamer: 33             -  Single bundle outside in technique with remnant preservation: 33   "
40563|NCT02754661|"     The primary objective of this multicenter, prospective, randomized study is to assess the     diagnostic yield of CCE versus CTC in a screening population.   "
40564|NCT02754648|"     Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than     laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with     ovarian endometrioma or not?   "
40565|NCT02754635|"     Induction of labor at term versus expectant management among women with abnormal maternal     biochemical markers. A randomized controlled trial   "
40588|NCT02754336|"     This pilot study compares the effect of working memory training and neurofeedback in     non-medicated children age 7 to 13 years with ADHD. Half of the participants will receive     working memory training, while the other half will receive neurofeedback.   "
40714|NCT02752698|"     Central South University in collaboration with Tianjin University developed the first     domestically produced Chinese minimally invasive surgical (MIS) robot system which named     Micro Hand S in 2013. Recently, as the domestic surgical robot research project's main     section, this new MIS robot had been authorized to enter the clinical trial stage by the     Ethics Committee of the Third Xiangya Hospital at Central South University.   "
40566|NCT02754622|"     Many patients who are admitted to the intensive care unit (ICU) experience muscle weakness.     This muscle weakness occurs whilst patients are unconscious, immobile in bed and on a     breathing machine (ventilator). It can develop very quickly, as soon as they become unwell.     The investigators know that this weakness can make it harder for patients to regain their     normal level of functional ability, such as standing and walking independently. Physical     rehabilitation, delivered by physiotherapists, is important for patients as they recover from     their critical illness to help them regain strength and to practice the ability to perform     physical activities. These activities include sitting on the edge of the bed, standing,     stepping on the spot and walking.      However it is difficult to know how hard it is for patients who are recovering from critical     illness to perform these types of activities - in other words, how much energy is required.     Some patients may find certain activities harder or easier than others. By knowing the energy     requirements of patients whilst they take part in different physical rehabilitation     activities, physiotherapists may be able to be more accurate with prescribing exercises and     designing rehabilitation sessions for patients to practice achieving those activities.      In this study, the investigators will measure the energy requirements of the patients when     they take part in physiotherapy-led physical rehabilitation they will have during their     admission. To do this, the investigators will use a different ventilator to the one normally     used to help their breathing. This ventilator works in exactly the same way, but has an extra     component built into it to measure energy requirements. After the rehabilitation session, the     patient will return to using their normal ventilator.   "
40567|NCT02754609|"     This trial is a Phase 1b multicentre, multinational, randomized, double-blind with     single-blind arm and open label extension phase, placebo controlled, clinical trial     evaluating the safety and predictability of an escalating gluten consumption to activate     Coeliac Disease (CeD) in (a) a small cohort of people with diet-managed CeD treated with a     placebo (n=10), and in (b) cohorts following low (L3-10; n=40) and medium (L3-20; n=10) dose     hookworm inocula.      The investigators 4 aims for the study are:      Aim 1: Undertake a multiple-phase and escalating gluten challenge assessing safety to gluten     exposure in hookworm-naïve and hookworm-infected people with CeD.      Aim 2: This phase Ib study recognizes that the evidence supporting this novel intervention is     rudimentary and addresses amongst others the following questions: (a) The importance of L3     dose on Participant health, and (b) the importance of L3 dose on the safety of escalating     gluten challenge and (c) the need for a comparator group should a phase II trial be     warranted.      Aim 3: Examine the changes in intestinal T cell responses induced by hookworm infection and     gluten exposure.      Aim 4: Assess the impact of hookworm infection and purified hookworm-derived proteins on     gluten peptide-specific immune responses ex vivo.   "
40568|NCT02754596|"     This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant     to timolol ophthalmic solution.   "
40569|NCT02754583|"     SWIFT is a series of 3 cluster-randomized trials designed to assess several alternative     strategies for trachoma control in communities that have been treated with many years of mass     azithromycin distributions. The first trial (named WUHA) compares communities that receive a     comprehensive Water, Sanitation, and Hygiene (WASH) package to those that receive no     intervention. The second trial (named TAITU-A) compares communities randomized to targeted     antibiotic treatment versus those randomized to mass antibiotics for trachoma, and the third     trial (TAITU-B) compares communities randomized to targeted antibiotics versus those     randomized to delayed antibiotics.   "
40570|NCT02754570|"     The aim of this study will be to determine the effects of pilocarpine as an adjunct     medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and     compare these effects to latanoprost alone.   "
40571|NCT02754557|"     The purpose of the study is to compare the efficacy of a physiologically-augmented     breath-focused mindfulness-based intervention to reduce symptoms of dissociation that are     associated with psychological trauma, as well as symptoms of posttraumatic stress disorder     (PTSD). The study will evaluate whether physiological augmentation produces a greater change     in dissociative symptoms, meditative engagement and attentional control, compared to     non-augmented mindfulness. The augmentation comprises physiological feedback in the form of a     vibration on the wrist. Vibrations are delivered by a device that will be placed on a     participant's arm; the device vibrates in proportion to the person's breath.   "
40572|NCT02754544|"     The goal of this clinical research study is to learn if using a larger than the standard     mapping grid currently used at MD Anderson during brain tumor surgery or a high-definition     grid for electrocorticogram (ECoG) brain mapping can help better identify which areas of the     brain are active during specific limb movement and speech. In this study, the result of two     types of ECoG mapping grids will be analyzed.      ECoG mapping will take place during participant's scheduled surgery. Before the procedure,     participant will be assigned one of the two types of mapping grids. The mapping grid will be     placed directly on the surface of participant's brain during surgery. Participant will not be     able to feel this. The grids contain electrodes attached to a computer to record brain     activity. A wireless digital glove will be used with the high-definition grid. The glove     records hand movements, while the grids shows the areas of the brain that are active during     the hand movements.   "
40573|NCT02754531|"     This study aims to compare the accuracy of measurement between ultrasonography and Cole     formula in predicting uncuffed endotracheal tube diameter.   "
40585|NCT02754375|"     Biological markers of depressive states have been studied, but their usefulness to predict     the therapeutic response is unknown. This issue is major in all depressive states which have     not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic     stimulation) is a non-pharmacological alternative in the treatment of depression, but its     effects on cerebral functioning are not known in episodes which have resist to conventional     treatments. The investigators will include 50 depressive patients who have failed to respond     to two successive antidepressant medication, and propose them a treatment with low frequency     rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission     tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in     order to measure induced metabolic changes and their correlation with clinical states.     Patients who have responded to rTMS acute treatment may continue this therapeutic for six     months, and the investigators will assess if efficacy maintenance is related with cerebral     metabolic variations   "
40574|NCT02754518|"     This study intends to measure the effects of valsartan/sacubitril compared to baseline     standard medical heart failure therapy on reverse remodeling using echocardiographic     endocardial surface analysis techniques to assess changes in ventricular volume, function,     and shape. Furthermore, Metaiodobenzylguanidine (MIBG) scintigraphy and the heart to     mediastinum ratio will be used to assess Left Ventricle (LV) volume regression and risk     reduction. The investigators also intend to measure the effects of valsartan/sacubitril on     exercise capacity as assessed by the 6 minute walk test and peak Volume of Oxygen (V02) on     cardiopulmonary exercise testing. Additionally, the investigators will examine the impact of     valsartan/sacubitril on functional status and quality of life using the Kansas City     Cardiomyopathy Questionnaire (KCCQ) and Qualia Health (a novel iPhone application that     incorporates Fitbit technology to provide a real time daily 6 minute step count and     assesses quality of life using a series of short targeted questions. The investigators will     also measure Brain Natriuretic Peptide (BNP), N-terminal of the Prohormone Brain Natriuretic     Peptide (NT-proBNP), and Rho-kinase (a biomarker associated with heart failure) levels at     multiple time-points throughout the study period.   "
40575|NCT02754505|"     Background: Few studies showed that early rehabilitation on the Intensive Care Unit (ICU)     results in a better functional outcome at hospital discharge and reduced hospital stay.     Effects of early rehabilitation at the general ward directly after transfer from the ICU on     the length of stay (LOS) in hospital and on the functional outcome are missing.      Methods: In a prospective randomised controlled trial (RCT) 53 consecutive     critical-illness-survivors were enrolled at nine ICUs. Early rehabilitation program     (protocol) consisted of exercise therapy, active breathing techniques and electrical     stimulation after discharge from the ICU to ward-based care. The usual care group received     physical therapy as ordered by the primary care team after discharge from the ICU. LOS at the     general ward after transfer from the ICU was recorded. Furthermore,     Early-Rehabilitation-Barthel-Index (ERBI), Visual-Analogue-Scale for pain (VAS),     3-Minute-walk-test (3min), Beck-Depression-Inventory (BDI), State-Trait-Anxiety-Inventory     (STAI), and Medical-Research-Council-scale (MRCS) were assessed.   "
40576|NCT02754492|"     To verify that platelets collected on the Trima Accel system with Version 7.0 software     enhancements and stored in 100% plasma meet the FDA requirements for leukoreduction (< 5.0 ×     10^6 residual white blood cells [WBC] per transfusable unit).   "
40577|NCT02754479|"     To evaluate the safety and effectiveness of the Excel V system for the treatment of lower     extremity spider veins on the ankles.   "
40578|NCT02754466|"     The present study aims evaluate the oral health conditions of schoolchildren and its relation     to growth, development and well-being. Also, it seeks to evaluate different restorative     interventions performed at school premises in primary teeth and its impact on the quality of     life.   "
40579|NCT02754453|"     There are three different phases to this study:        1. Screening phase to determine if you are eligible to participate in the study.        2. Study phase, which will entail diet and activity, exercise and then finally self          monitoring goals.        3. End of treatment phase where you will be asked to complete questionnaires.   "
40580|NCT02754440|"     To verify that platelets collected on the Trima Accel system with Version 7.0 software     enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for     leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).   "
40581|NCT02754427|"     Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance     model with arm assessment pre-surgery followed by ongoing surveillance and targeted     physiotherapy treatment after breast cancer surgery may improve early detection and     management of arm morbidity. This study aims to determine the effect of prospective     surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance     group compared to control group at 12-months after breast cancer surgery.   "
40582|NCT02754414|"     This is a platelet transfusion study. The purpose of this study is to measure the life span     and quality of platelets stored in a refrigerator. Participants will give platelets by     apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own     stored platelets will be tagged with a radioactive isotope and infused back into the     participant. This will enable us to track how many transfused platelets survive after storage     in the refrigerator.   "
40583|NCT02754401|"     200 patients took part in the questionnaire and were examined using the PSI. Thereafter the     participants were divided into two groups, non-periodontitis persons (group 1; PSI 0-2) and     periodontitis persons (group 2; PSI 3-4). The answers were evaluated using a point system     ranging from 0 to 8, based on known periodontal risk factors and their assumed degree of     influence. Receiver-operating characteristic (ROC) curve analyses were applied to examine the     overall discriminatory power, sensitivity and specificity, and corresponding cut-off points     of the self-reported periodontal disease scale.   "
40584|NCT02754388|"     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis     of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought     to be the best screening tool for lung cancer. However, there is growing concerns about     radiation exposure, high cost, and high rate of false-positive screening result.     Epidemiologic studies from western countries showed that cigarette smoking is the major cause     of lung cancer, and other risk factors may include age, environmental pollution, occupational     exposures (included of radon exposure), gender, race, and pre-existing lung diseases.     Adenocarcinoma is the major type of lung cancer in Taiwan and is less attributable to     smoking. The investigators need a different risk prediction model adapted to the     investigators country.      National Taiwan University Hospital Chu-Tung Branch initiated the lung cancer screening by     LDCT since June 2015. Many people can get the LDCT screening with affordable price with the     subsidy from enterprise donation. The purpose of this study is observing those participants     with 2-year follow-up. Furthermore, those data may connect with another study of Low dose     computed tomography screening study in nonsmoker with risk factors for lung cancer in Taiwan     （Non-smoker study）which is implemented in other hospitals in Taiwan.   "
40741|NCT02752347|"     Compare the impact of using rapid maxillary expanders on masticatory muscle activities     (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient     (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of     the same preadolescent unilateral crossbite patient before the expansion and after one month     of the completion treatment period using surface electromyography device.   "
40589|NCT02754323|"     There are different definitions of stress according to each discipline. In psychology, it is     defined according to the individual's ability to adapt. The medical approach focuses on the     reactions of the body to stress situations. And the organizational approach seeks to define     in terms of sources of stress situations. According to a national interprofessional agreement     on stress at work in 2008 is defined as a condition that occurs when there is an imbalance     between the perception of a person with constraints imposed by its environment and the     perception that it has its own resources to cope.      Stress at work      INRS emphasizes prevention to fight against the cost of work stress and seeks to develop     methods and tools objectification stressful situations. The social cost of workplace stress     would represent 10 to 20% of the expenses of the branch for employment injuries /     occupational diseases of the Social Security According to a survey by the European Agency for     Safety and Health at Work conducted in 1999, stress is the cause of 50 to 60% of all lost     working days. The cost of occupational stress assessed by INRS represent 830 million euros in     2000 in France.      Media coverage of working conditions related suicides has prompted some companies to     communicate about work stress and develop actions.      According to the study of Sumer in 2003, 61% of employees have a highly stressful job and 27%     complained of work-related health problems.      However, the 2009 survey shows that job stress is a major risk factor for mental health and     is associated with decreased job performance. Burnout sets in stages idealistic enthusiasm,     stagnation, frustration, apathy. Therefore, it is essential to track the state of chronic     stress as soon as possible to prevent burnout.      Stress testing procedures      The major problem is that there is not now comprehensively measure of stress. The measurement     models that are available to date, all incomplete, can be classified according to two     categories.      First, the general patterns that measure only partially stress but which can be used in any     type of fields. One application of self-KARASEK and the imbalance of effort / reward     SIEGRIST. These two models are mainly used for epidemiological studies on job stress.      Second, the specific models that provide a more comprehensive measure but we can only use in     the area from which they come. These measure specific stressors (organizational, professional     and emotional) in the study population.      The main objective of this study is evaluate the feasibility and validate the measurement of     chronic stress by CODESNA tool. The method is to compare the measured result by the CODESNA     tool to measure stress questionnaires collected by the Maslach Burnout INVENTORY and KARASEK.     This method explores finely enough constraints and allows a comparison of national data.   "
40590|NCT02754310|"     Repeated exposure to simulated cases has been shown to improve performance, but repeating the     same scenario may impair the ability of learners to transfer their knowledge and skills to     slightly different situations. The objective of this study is to compare the use of repeated     versus varied simulation cases for teaching the management of pediatric asthma exacerbation     to 3rd year medical students.   "
40591|NCT02754297|"     In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate)     will be personalized, i.e. administered activity of LuTate will be tailored for each patient     to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.      The purpose of this study is to:        -  Assess the objective (radiological), symptomatic and biochemical response rates          following an induction course of personalized PRRT;        -  Assess the overall, the disease-specific, and the progression-free survival following          P-PRRT;        -  Correlate therapeutic response and survival with tumor absorbed radiation dose;        -  Evaluate the acute, subacute and chronic adverse events following P-PRRT;        -  Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed          radiation doses to organs at risk;        -  Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20          patients (sub-study funded by the Canadian Institutes of Health Research).      This study also has a compassionate purpose, which is to provide access to PRRT to patients.   "
40592|NCT02754284|"     This study is carried out to explore the short-term and long-term efficacy of the functional     collagen scaffold in guiding laryngeal soft tissue regeneration.   "
40593|NCT02754271|"     Exercise training for older hemodialysis patients can greatly improve many of the negative     effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet     to be incorporated effectively and systematically into routine care. Exercise programs remain     rare. When such programs are implemented, their participation rates vary, and they neglect     home and community-based activities, as well as the involvement of family caregivers to     support and reinforce exercise. This study is intended to address these limitations by     introducing a highly accessible and compelling educational film, Fit for Dialysis, designed     to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis     patients, and exercise counseling and support by family caregivers, nephrologists, and     nurses. The objective of this clinical trial is to determine whether and in what ways Fit for     Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of     exercise-based principles of wellness in the context of end-stage renal disease. Ultimately     Fit for Dialysis could be used as a model for dialysis education that supports guideline     recommendations that exercise be incorporated into the care and treatment of dialysis     patients.   "
47338|NCT02666001|"     The study is being conducted to assess the effect of multiple doses of BMS-663068 on the     exposure of methadone in subjects on a stable dose of methadone, and the exposure of     buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and     norbuprenorphine.   "
40594|NCT02754258|"     The Problem: Obesity is one of the leading causes of chronic disease and death. The efficacy     of diet and exercise to sustain weight loss over the long term is weak. While pharmacotherapy     is more effective than behavior intervention in maintaining weight loss the effects are often     not sufficient to achieve optimal health benefits. Current drug treatments may be sub-optimal     because they do not directly target the rewarding value of food, drive to eat, food liking,     and impulsivity for eating energy dense snack foods, all of which influences both quantity     and quality of food intake and impacts adherence needed to maintain weight loss.      The Solution: The limitations in current anti-obesity agents are potentially addressed by     Methylphenidate (MPH). We showed that MPH reduces food intake, dietary fat intake, hunger and     food reward, as increase resting energy expenditure in obese and non-obese adults;however, no     controlled field trials have been conducted in obese individuals without ADHD.      Objectives/Hypotheses: Primary: To test the effects of MPH on energy intake in obese men and     women. Secondary: to examine the effects of MPH on energy expenditure, body weight,     impulsivity, food reward, and olfaction. The investigators predict that compared to placebo,     MPH will show reduced appetite, along with reduced impulsivity, food reward, and smell     function.      Deliverable: This study may be the first to establish the short-term efficacy and safety of     using MPH for weight loss, and if successful, data will inform a larger trial that can     potentially identify MPH as a novel therapeutic agent for treating obesity and related     chronic diseases in a predisposed population.   "
40595|NCT02754245|"     The aim of this study is to externally validate a new emergency department overcrowding     estimation tool (SONET) developed at John Peter Smith Health Network (JPS).   "
40728|NCT02752516|"     A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study     the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable     regimen for subsequent research.   "
40596|NCT02754232|"     Problem:      Training is an important part of the treatment and rehabilitation of patients with chronic     obstructive pulmonary disease (COPD) because training can increase the patient's muscle mass,     lead to higher physical performance, reduce difficulties in breathing and hereby increase the     patients' capacity to make use of the medical treatment.      Rehabilitation is provided by hospitals training centres/outpatient clinics. However, the     transport is too tiring for the patients, which is why they decline taking part in it. This     can mean a worsening of their condition and an increase in readmissions.      Solution:        -  To develop a better treatment for patients with severe COPD: Telemedical training of          patients with COPD in teams.        -  To develop a cross-sectoral practice for the telemedical training patients will use,          thus decreasing the readmissions of OUH's patients with severe COPD        -  To optimize the patient's journey in and across sector borders by using Lean methods.      Perspective:      The study is expected to contribute to improving treatment of severely ill patients with COPD     cross-sectorally. The results are expected to contribute to reducing readmissions and raising     the level of evidence in telemedical research on training patients with severe COPD. The     study's findings may be of use in relation to other patient groups who have difficulties     coming to training.      Background:      This research project has its starting point in a pilot project. Its goal was to determine     whether severely ill COPD patients could train at home and earlier than normal. Evaluation     showed patients found it reassuring to train with the help of the COPD briefcase. They found     it increased their physical and mental well-being.      Method:      To gain knowledge of the effect of telemedical training. The patient's strength, daily     activity level and quality of life will be measured by conducting a randomized controlled     trial including 125 patients - 62 in the intervention group and 62 in the control group.      Qualitative research methods will be used to explore the user perspective concerning     patients, family and health professionals. The method is critical psychological practice     research.      A Lean method consultant from University Hospital Odense (OUH) will be involved in developing     the best clinical pathway for the patients and the professionals.   "
40597|NCT02754219|"     The objective of the study is to compare the pharmacokinetics profiles and safety of     Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral     dose of Evogliptin   "
40598|NCT02754206|"     The purpose of this study is to understand how biochemical markers in blood, balance     disturbances, and cognitive performance are related to brain blood flow changes after a     concussion.   "
40599|NCT02754193|"     A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C)     during 24 hours ± 1h versus normothermia (37°C ± 0.3 °C), comparative open trial will be     conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.      The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between     33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality     in comparison with the normothermia group (37°C ± 0.3°C).   "
40600|NCT02754180|"     Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With     R1 Resection and/or Positive Lymph Nodes after curative resection.   "
40601|NCT02754167|"     Anticalins® are engineered human proteins that are able to bind specific target molecules.     The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin     and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall     investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of     PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.   "
40602|NCT02754154|"     The purpose of this study is to compare the risk of major bleeding event among nonvalvular     atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.   "
40603|NCT02754141|"     The purpose of this study is to assess the safety and tumor-shrinking ability of experimental     medication BMS-986179 when combined with Nivolumab, in patients with solid cancers that are     advanced or have spread.   "
40604|NCT02754128|"     The purpose of this study is to compare a motor learning (ML)-based gait-related training     intervention to a functional lower limb strength training intervention, with a concurrent     evaluation of functional, neural and participation outcomes for children and youth with     Cerebral Palsy (CP).      This study is a two-group, parallel arm RCT in which twenty-two children with CP in GMFCS     Levels I-II will be randomly allocated to a 6-week, 16 session program of: (i) ML based gait     training or (ii) lower limb strength training. Outcome assessments occur pre/post/4-months     post-intervention.   "
40615|NCT02753985|"     This is a qualitative study which explores the role that partners play in breast cancer     survivors adherence to aromatase inhibitors and management of their side effects. Both     patients and their partners will be interviewed (separately) in order to capture multiple     perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary     method of data collection will be face-to-face semi-structured interviews. These interviews     will be audio-recorded.   "
40742|NCT02752334|"     This study evaluated the motor and sensory block duration and the postoperative analgesic     effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular     brachial plexus block Anesthesia. Motor and sensory block duration were considered as a     primary endpoint.   "
40743|NCT02752321|"     The purpose of this study is to determine whether the addition of a mobile or web based     multimedia discharge application (eDischarge) to the discharge process is effective in     improving patient experience, engagement, and clinical outcomes in the early post discharge     period.   "
40605|NCT02754115|"     Peritoneal carcinomatosis is a common event in the natural history of colorectal and other     digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal     chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients     with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer,     gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient     survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and     pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C)     and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all     microscopic metastasis.      CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during     debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC     phase, and even in the early postoperative period, with resultant significant morbidity and     mortality. Despite that most of the reported patients are in American Society of     Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the     morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team     of anesthesiologist, surgeons and intensivist and other ancillary services can result in good     outcome. This study will see the challenges faced by the team regarding the     pathophysiological alterations during the CRS with HIPEC in the perioperative period.   "
40606|NCT02754102|"     To determine the phototoxic potential of a topically applied article in human subjects.   "
40607|NCT02754089|"     The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as     Somagh on body weight.   "
40609|NCT02754063|"     Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and     its intensity is directly related to the neurological outcome. The thresholds for     irreversible tissue damage following TBI indicate a particular vulnerability of injured     brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in     the intensive care unit (ICU).      The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP)     - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To     prevent ischemia due to elevated ICP, current international guidelines recommend maintaining     CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as     assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite     optimization of CPP and ICP, and have been independently associated with poorer patient     outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an     independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2     was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort     studies of severely head-injured patients. On the basis of these findings, it is hypothesized     that an early optimization of brain oxygenation, together with keeping ICP and CPP within     recommended values, could reduce the volume of vulnerable lesions following severe TBI and     possibly improve neurological outcome.   "
40610|NCT02754050|"     The device is intended to endoscopically transect polyps in the gastrointestinal tract     (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is     captured, retrieved and submitted for pathological analysis. The Tandem Snare is an     intervention tool inserted through the colonoscope for the resection and removal of polyps     sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the     polyp, lift it up, resect and remove it without losing it. This is a feasibility study aiming     to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in     screening, diagnostic or surveillance colonoscopy.   "
40611|NCT02754037|"     The goal of this study is to evaluate non-invasive imaging techniques for determining liver     steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue     scarring).In addition, the study group will be using other test measures including personal     demographics, laboratory blood test results, and imaging measurements to determine the     severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis),     inflammation, and fibrosis.   "
40612|NCT02754024|"     In the past years several shoulder reconstruction systems with different types of prostheses     and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a     wide range of pathologies and revision situations. The aim of the present study is to report     radiological and clinical outcome with a stemless shoulder implant with hollow screw     fixation.   "
40613|NCT02754011|"     The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced     or metastatic breast cancer HER2 negative patients and divided into 2 parts:        -  STEP 1: a dose escalation part (n= up to 30) to evaluate the safety profile and          pharmacokinetics and to define the MTD and RP2D to recommend in a phase II.        -  STEP 2: an expansion cohort part to confirm the safety and tolerability of ribociclib          and capecitabine association on a longer follow-up, and to obtain preliminary evidence          of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients.          Up to 14 patients in each cohort, taking into account patients already included in step          one at this DL, may be enrolled, for a total of 28 at the RP2D.   "
40614|NCT02753998|"     The primary objective of this double-blind study is to compare the frequency of primary     patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either     by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by     conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with     paclitaxel).      The other objectives of the study are:        1. To compare the frequency of primary patency at 3 months and 12 months.        2. To compare the rate of restenosis > 50% at the site of angioplasty at 3, 6 and 12          months.        3. To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous fistula          deteriorating back to preoperative flow rate (within 20% of preoperative flow rate).        4. To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate < 500 ml /          min.        5. To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis.        6. To compare, at 3, 6 and 12 months, the medical costs related to direct medical care,          initial treatments, monitoring, diagnosis and treatments of complications.   "
40616|NCT02753972|"     Background: Mindfulness-based interventions may be effective in reducing the stress that may     increase both obesity and inflammation.      Purpose: The purpose of this study was to examine the effects of a mindful eating     intervention on weight loss and health-related outcomes.      Methods: Thirty-six obese, postmenopausal women were randomized to a six-week Mindful Eating     and Living (MEAL) intervention or an active control group (CONT) consisting of nutritional     counseling, goal setting, and group support. Weight, body mass index (BMI), waist-hip ratio     (WHR), binge eating, interleukin-6 (IL-6) and C-reactive protein (CRP) were assessed at     baseline and four follow-up periods up to one year.      Results: Multilevel analyses showed that the MEAL group had reductions in weight, BMI, WHR,     binge eating, IL-6, and CRP; the CONT group had reductions in weight, BMI, and binge eating.     The reductions in binge eating, IL-6, and CRP were greater for the MEAL as compared with the     CONT group.      Conclusions: This study suggests that a mindfulness-based eating intervention may promote     weight loss and reduce a variety of health-related risk factors in post-menopausal women who     are obese.   "
40638|NCT02753686|"     Although randomized controlled trials (RCTs) provide evidence of efficacy, generalization of     these results to patients in the real-world setting is challenging, given RCTs are conducted     in highly selected patient populations.      An understanding of the effectiveness and safety of approved cancer therapies in routine     clinical practice is essential in order to optimize the management of these patients and to     identify treatment and safety gaps.      This is the first Canadian study to describe real-world treatment patterns/sequencing,     effectiveness and safety for postmenopausal HR+ HER2- advanced breast cancer patients. This     registry incorporates an observational prospective cohort design and will enroll 320     postmenopausal HR+ HER2- advanced breast cancer women that have been previously exposed to     non-steroidal aromatase inhibitor (NSAI) therapy being treated with endocrine therapy (ET) or     ET in combination with targeted therapy (TT).   "
40617|NCT02753959|"     Patients with NMD can suffer from a range of respiratory problems due to respiratory muscle     weakness. Cough muscle weakness worsens secretion clearance from the airways, and increases     the risk of infection. As a result, these patients often require chest physiotherapy or are     supported with devices to aid clearance (such as mechanical insufflation-exsufflation) to     reduce the risk of infection. Although evidence supports the use of these devices, the     optimal technique or settings on the device are not clear.      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of     sensors around the chest that provides information on how well the lungs are being filled     with air. It allows a non-invasive assessment of the effect of each secretion clearance     technique on lung ventilation in real-time.      This study aims to compare how well the lung is filled with air between three different     techniques for secretion clearance (clearing mucus and phlegm from the airways), in order to     determine which of the techniques is the most effective, in patients with NMD.   "
40618|NCT02753946|"     The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin)     as non-inferior to piperacillin/tazobactam in overall success (clinical cure and     microbiologic eradication) for the treatment of hospitalized patients with complicated     urinary tract infections (cUTI) or acute pyelonephritis (AP).   "
40619|NCT02753933|"     This study aims to evaluate whether direct access from General Practitioners (GPs) to     Magnetic Resonance Imaging (MRI) for patients with chronic headache decreases overall NHS     costs and increases patient satisfaction compared to clinical practice with referral to     Neurology Services.   "
40620|NCT02753920|"     Voiding difficulties are common after prolapse and incontinence surgeries. All patients after     vaginal prolapse surgery must complete a voiding trial if they are to be discharged home     without a catheter. Accepted protocols for voiding trials after prolapse and incontinence     surgeries do not exist. The purpose of this study is to compare two different types of     postoperative voiding trials to determine which leads to less postoperative issues, such as     urinary retention requiring catheterization. You are being asked to participate because you     are having a vaginal apex suspension surgery.   "
40621|NCT02753907|"     Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30     kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group     (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50)     maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice     and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and     lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8     week alongside other cardiovascular disease risk factors.   "
40622|NCT02753894|"     The objective of this study is to examine the clinical dose range of ASP1585 based on the     efficacy, safety, and feasibility of treatment in chronic kidney disease patients on     hemodialysis with hyperphosphatemia.   "
40623|NCT02753881|"     Patients with primary and secondary liver cancer may participate in this study. The purpose     is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on     the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization     (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an     injection of small beads to block the tumor-feeding arteries. Doxorubicin is a     chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin     pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive     super-selective CTACE (i.e., delivered in close proximity to the tumor).   "
40624|NCT02753868|"     The purpose of this study is to examine the effect of cycling at mild to moderate intensity     during hemodialysis treatment on cardiovascular function in a crossover design.   "
40625|NCT02753855|"     The purpose of this study is to characterize plasma and urinary concentrations of telavancin     following intravenous administration of a single dose of telavancin in healthy subjects who     are normal weight, overweight, and obese.   "
40626|NCT02753842|"     This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with     women (MSW) in a double-blind, three-way randomized crossover trial with conditions of     fitted, thin, and standard condoms. The study will provide fitted condoms in 56 sizes based     on combinations of length (approximately 10 mm increments) and circumference (approximately 2     mm increments), with user-determined size based on a paper template measurement instrument.      Participants will be randomly assigned to the sequence in which the crossover intervention     conditions (fitted, thin, and standard condoms) occur, with five study condoms provided for     each condition. Participants will attend at least four, and up to seven, biweekly study     visits.   "
40636|NCT02753712|"     The purpose of this study is to demonstrate improvement of peripheral airway resistance     (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).   "
40637|NCT02753699|"     The purpose of this study is to follow-up with participants from feeder studies who achieved     sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability     of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma     and post-treatment safety over time.      Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301     (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks     with a maximum of 3 visits. No treatment is involved.   "
40639|NCT02753673|"     The purpose of this study is to develop a questionnaire to measure patient expectations of     breast-conserving therapy (breast-conserving surgery and radiation). This questionnaire will     assist both surgeons and patients by helping provide valuable information to patients about     what to expect during and after surgery.   "
40640|NCT02753660|"     The aim of this study was to compare the successful spinal puncture among patients with     pendant position in comparison with those who used traditional sitting position for caesarean     section.   "
40641|NCT02753647|"     This is a prospective, single-arm, open-label phase II study of Chidamide in combination with     R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma     patients.   "
40729|NCT02752503|"     The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in     subjects with alcohol use disorder and comorbid BPD.   "
40627|NCT02753829|"     The sample of this randomized controlled trial was obtained in the Cardiovascular Prevention     and Rehabilitation Unit, of the Hospital Centre of Porto, Santo Antonio General Hospital. The     target population was individuals who have completed the training phase of cardiovascular     rehabilitation program, volunteers and referenced by the responsible for the service.      This study has as main objective to analyze the influence of a specific exercise program,     maintenance phase of cardiovascular rehabilitation , in home care context, for a period of 6     months, using a virtual format (computer and Kinect) or a conventional format (paper manual)     in subjects with coronary artery disease. It was intended to analyze the immediate effect of     exercise program on body composition and food consumption patterns, functional muscle     strength of lower limb, level of physical activity: total volume of activity as well as the     profile of this intensity, kyphotic index, balance, cognitive and executive function, as well     as in the quality of life.      The aim is also to examine the effects, approximately 3 months after the end of the exercise     program, in the lipid profile, the level of physical activity: total volume of activity as     well as the profile of this intensity and cardiovascular fitness: maximum double product ;     metabolic equivalents; and proof and recovery time.      The individuals were distributed at random, every 3 individuals, using the capabilities of     Microsoft Excel 2010 RANDBETWEEN command, by three groups: the experimental group 1- a     cardiovascular rehabilitation program, in home care context, using a computer and Kinect,     virtual format, the experimental group 2- in cardiovascular rehabilitation program, in home     care context, using a paper-based manual, conventional format, and control group-only subject     to education for cardiovascular risk factors.      The program defined 3 training sessions per week. The rehabilitation program was oriented by     the guidelines for exercise prescription.      Participants perform the a program of specific exercises independently and individually, with     remote supervision, using communication (phone, email, etc.) and a routine scheduled     individual meetings.   "
40628|NCT02753816|"     Major surgery can result in blood loss that can require a blood transfusion during and/or     after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's     as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and     studied in patients undergoing open-heart surgery, liver transplantation, and urologic     surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to     major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and     possibly decreased hospital costs related to your stay.      In this study, prior to each surgical procedure to treat the participants burn injury, the     participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid     that looks like the tranexamic acid medicine, but does not have any active ingredient in it.     In this study, both the tranexamic acid and the placebo are considered research.   "
40629|NCT02753803|"     A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate     the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone     30 mg after oral administration in healthy male subjects   "
40630|NCT02753790|"     Some cancers can spread, or metastasize, to the brain. When they do, treatment often involves     surgery and/or radiation. Optimal treatment of brain metastases would maximize disease     control and minimize toxicity (or side effects), and improve the quality of life of patients.     A common type of radiation used for brain metastases is called whole brain radiation, which     treats not just the cancer that can be seen on scans (i.e., gross disease), but the smaller     sites of cancer that may not be visible (i.e. subclinical disease). Fractionation is used to     describe repetitive treatments in which small doses (fractions) of a total planned dose are     given at separate clinic visits. The most common dosing regimen is 30 Gray (Gy), using 3 Gy     per fraction over 10 fractions. Previous studies have suggested that using intensity     modulated radiation therapy (IMRT) may be a safer way to deliver higher doses to gross     disease and lower doses to the rest of the brain that may contain subclinical disease. This     approach may spare the rest of the brain from radiation complications and side effects.      The goal of this study is to determine whether using IMRT to treat brain metastases is more     effective than current standard whole brain radiation in controlling gross disease and     whether patient quality of life and hair loss is improved compared to previous studies using     whole brain radiation.   "
40631|NCT02753777|"     Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that     pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will     require the availability of validated disease severity measures that can be used to define     primary outcomes.   "
40632|NCT02753764|"     This is a double-blind, placebo controlled 4 week crossover study to investigate the efficacy     and safety of AZD7624 (an inhaled p38 inhibitor) in corticosteroid resistant (CR) asthmatics.     For the purpose of this study 10 symptomatic CR asthma patients with a FEV1% predicted <80%     and normal bronchodilator response, 10 CS asthmatics and 10 healthy controls will be     recruited.   "
40633|NCT02753751|"     This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them     to usual care versus an electronic alert coupled to a best practices order set.   "
40634|NCT02753738|"     Background:      Conclusive evidence states that the serotonergic system mediates neuroplasticity from early     embryonic development until brain maturation in adulthood. This study aims to demonstrate     that selective serotonin reuptake inhibitors (SSRIs) enhance learning-dependent     neuroplasticity in vivo, hereby contributing to the investigators understanding of the     mechanism of action of therapy with SSRIs.      Objectives:        1. To prove a positive influence of SSRIs on structural remodeling during learning,          reflected by enhancements of gray and white matter microstructure, connectivity and          functionality in brain regions involved in learning processes.        2. To show that this effect is topologically specific, i.e. that enhancements of plasticity          markers are found in different regions depending on their involvement during the          performance of specific learning tasks.      Study design:      Randomized, double-blind, placebo-controlled, longitudinal mono-center study. 80 healthy     subjects will undergo three MRI scanning sessions: 1. baseline, at study entry, 2. after 3     weeks of facial/emotional (n=40) or Chinese character-meaning learning (n=40) and 3. after 3     weeks learning of new associations under administration of an SSRI or placebo.      Methods:      MRI measurements will be performed on a 3 Tesla PRISMA MAGNETOM MR scanner. Changes in gray     matter microstructure will be assessed using high-resolution structural MRI and analyzed with     voxel-based morphometry (VBM). Diffusion tensor imaging (DTI) enables non-invasive     investigation of neuroplasticity in the human brain based on the reduction in mean     diffusivity associated with swelling of astrocytes after increased synaptic activity.     Resting-state functional MRI (fMRI) will allow for the measurement of changes in functional     coupling between brain regions, and fMRI during tasks will assess differential activity in     brain regions during learning.      Relevance and implications:      This study aims to provide evidence that SSRIs facilitate cytoarchitectonical restructuring.     In addition to expanding the investigators current knowledge on the trophic effects of SSRIs,     the results of this study will also elucidate interactions between the serotonergic system     and changes to neuronal networks during learning as well as their behavioral consequences. By     probing the neurobiological correlates of the antidepressant and anti-anxiety effects of     SSRIs, this study will provide a rationale for targeted interventions that harness the     neuroplasticity enhancing properties of SSRIs to facilitate therapeutic processes.   "
40635|NCT02753725|"     This study will be a randomized double blind placebo controlled clinical trial among children     undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a     dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to     Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery     determined by the time when the mouth gag will be removed. The main outcome will be incidence     of ED at the recovery room using Watcha scale and secondary outcomes will be delay in     emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.   "
40642|NCT02753634|"     Osteoarthritis (OA) is a growing burden in an aging society. There are few proven treatments     and hence disability contributes to poor quality of life and direct/indirect costs to     society. OA symptoms include both increased pain and reduced mobility. Strength training and     aerobic exercise has been shown to improve symptoms in OA; however, the impact of targeted     mobility and balance training in patients with osteoarthritis is unclear. The investigators     propose a novel, low-impact exercise modality that improves balance and gait. The results of     this research project should improve patient options and improve knowledge in OA management.   "
40643|NCT02753621|"     The overall objective of this study is to observe the effect of group Vocal performance     training and performance experience on patients' reported symptoms and quality of life. The     effectiveness of PD medications varies significantly in different patients depending on their     symptoms. By using music-based interventions to improve symptoms that may be inadequately     treated by medications, the investigators hope to improve quality of life in PD patients.     Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in     Parkinson disease (PD) is a controlled crossover behavioral intervention study of once     weekly choral classes for patients with idiopathic PD (progressing toward a group     performance) and once weekly discussion/support group meetings.   "
40644|NCT02753608|"     The study goal consists in the sequential collection of exhaled breath condensates (EBC) from     patients receiving invasive ventilation. Subsequent Raman spectroscopy aims at the     identification of putative biomarkers that could enable rapid early distinction of     Ventilator-associated pneumonia.   "
40645|NCT02753595|"     The primary objective for the study is as follows:      For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of     eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in     participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast     cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the     metastatic setting.      For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in     combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC     previously treated with up to 2 lines of systemic anticancer therapy in the metastatic     setting.   "
40646|NCT02753582|"     The primary objective is to determine the effect of SOD enzyme on frailty and health related     quality of life among Indonesian pre-frail elderly.      The secondary objective is to determine the effect of SOD enzyme on anti-oxidant status,     morbidity, and hospitalization among Indonesian pre-frail elderly.      The study hypothesis:        1. SOD enzyme can improve frailty status and health related quality of life among          Indonesian pre-frail elderly.        2. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.        3. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.        4. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.   "
40647|NCT02753569|"     This feasibility study will aim to assess the potential for functional imaging biomarkers     (18FDG PET-CT and DW-MRI) to differentiate immunotherapy induced inflammation, indicative of     response from non-response in patients with stage IV non-small cell lung cancer (NSCLC).   "
40648|NCT02753556|"     ScreenFlow is a chronic obstructive pulmonary disease (COPD) screening tool currently being     studied and iteratively developed that incorporates a questionnaire administered on a tablet     and data from a digital peak flow meter to calculate a risk score to identify the risk of     developing moderate-to-severe COPD for the participant. The purpose of this study is to     assess the usability of ScreenFlow deployed as a free-standing kiosk and observe where users     encounter trouble navigating the system. The kiosk will be situated in a public area of a     hospital where passersby can approach and fill out a ScreenFlow survey if they meet the     eligibility criteria. A subset of participants will be asked to participate in a follow-up     questionnaire about their experience using the system and about any follow-up action they may     have taken caused by their results from the ScreenFlow screening.   "
40649|NCT02753543|"     This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in     combination with previous chemotherapy in peripheral T cell lymphoma patients who did not     achieve complete response after 3 cycles of chemotherapy in interim evaluation.   "
40685|NCT02753075|"     This study will investigate the longitudinal efficacy of two experimental oral rinses, one     containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per     Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal     hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice     daily brushing with a standard fluoride toothpaste.   "
40651|NCT02753517|"     Extended hepatectomies of 4 or more segments are complicated by high rates of morbidity and     mortality, mainly related to hepatic liver failure. Nowadays, preoperative assessment of the     future remnant liver is just performed through its volumetric measurement by computed     tomography. Nevertheless, this volumetric assessment does not reflect the hepatocellular     function of the future remnant liver that can be disturbed in case of vascular and/or biliary     obstruction, chemotherapy-induced liver injuries or steatosis in overweight patients.     Literature data (albeit originating from a single centre in Europe) have suggested that     (99m)Tc-mebrofenin hepatobiliary scintigraphy could be useful in evaluating the function of     the future remnant liver. The aim of this prospective multicentric study is to determine the     predictive value of hepatobiliary scintigraphy in assessing the risk of postoperative liver     failure of extended hepatectomies of 4 or more segments in noncirrhotic liver.   "
40652|NCT02753504|"     The purpose of this study is to investigate the safety/tolerability and     pharmacokinetics/pharmacodynamics of CKD-519   "
40653|NCT02753491|"     This study designed for primary care practionars for chronic care in primary care. A new     model of motivational short interview used for intervention. The aim of this study is to     develop diet and exercise regimens in type 2 diabetic patients.   "
40654|NCT02753478|"     Hypothermia may reduce infarct size in patients with acute myocardial infarction if provided     before reperfusion. Human studies using systemic cooling methods failed to show a reduction     in infarction size. The use of selective intracoronary hypothermia may overcome the problems     of systemic cooling.      The hypothesis of this study is that in patients with acute myocardial infarction, the     induction of intracoronary hypothermia is safe and feasible.   "
40655|NCT02753465|"     During surgery for rectal cancer, there is considerable controversy regarding the optimal     level of ligation of the inferior mesenteric artery. Several studies have demonstrated the     benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to     achieve block dissection of lymph node metastases along the root of the inferior mesenteric     artery. In contrast, other studies have shown a significant decrease in blood flow after     inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia and     the long-term outcomes were not significantly different between high ligation of the inferior     mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty     tissues and nodes in the angle between the inferior mesenteric artery and the left colic     artery and the artery was ligated below the left colic artery. In the present clinical trial,     the investigators perform laparoscopic surgery with this management strategy in rectal     cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term     outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric     artery with preservation of the left colic artery for rectal cancer.   "
40656|NCT02753452|"     In Canada, between 3.6% and 7.7% of children under 19 years old are thought to have a chronic     health condition that results in disability or limits to activity. These young people have     difficulty finding jobs, attending school, living independently, and forming relationships     with other people. These poorer life outcomes are partly the result of a lack of life skills.     Life skills include the ability to solve problems and set goals, which allows youth to deal     with the demands of everyday life. Several children's treatment centres in Ontario offer     short-term residential immersive life skills (RILS) programs to provide youth with these life     skills to help them take on adult roles. RILS programs are very promising in terms of making     a long-term difference in youths' lives because they provide a place where youth can learn by     doing, working with peers and taking risks in a safe environment. However, we do not yet know     how well skills that are learned in RILS programs are kept up as time passes or how well RILS     programs support broader skills, such as the ability to make one's own choices.      The proposed research will examine these issues and will ask the following questions:        1. What opportunities are youth given when they participate in RILS programs? What specific          strategies do RILS service providers use to support youth in learning life skills?;        2. How do youth experience and perceive their participation in a RILS program, before,          during and after they take part? What do their parents expect and experience in terms of          their child's participation?; and        3. What changes do youth experience, particularly in terms of their ability to make choices          for themselves and their sense of being able to cope with things that come up in their          lives? The study will involve youth from several treatment centres in Ontario over the          next three years.      Youth who are attending RILS programs will be compared with:        1. youth who are similar to the RILS youth, but who are taking part in a life skills          program that is not residential;        2. youth who applied to a RILS program and were accepted, but who will take part in the          program in a different year; and        3. a group of youth who are similar to the RILS youth but who are not taking part in any          life skills program.      Youth will provide data at four time points: before the program starts, immediately after the     program finishes, three months after the program is over and 12 months after the program is     over.   "
40657|NCT02753439|"     A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the     investigators augment unilaterally and compare periodontal parameters in between.   "
40658|NCT02753426|"     The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID)     will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic     kidney disease.   "
40659|NCT02753413|"     The purpose of this study is to assess the safety and reactogenicity of a single     intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant     women aged 18 to 45 years.   "
40660|NCT02753400|"     To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor     biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.   "
40661|NCT02753387|"     Surgical site infections are an important health indicator for hospitals and a significant     medico-economic issue.      The aim of the study is to assess the impact of chlorhexidine mouthwash performed before     surgery on the bacterial colonization of the pharyngeal mucosa.   "
40662|NCT02753374|"     This study is a multicenter, prospective cohort study of patients diagnosed with cystic     fibrosis, the clinical information of recruited patients, including clinical manifestations,     lung function, chest imaging, quality of life and other indicators, will be followed for 10     years.   "
40663|NCT02753361|"     There is limited information on using the ultrasonography for block placement concerning     lipoma excision. A new type of regional blockade, performed under ultrasound, can ensure     proper block placement with accurate local anesthetics deposition. Investigators hypothesized     that ultrasound guidance can reduce the number of needle passes to complete the block     placement. Investigators will compare namely ultrasound guided regional blockade and     traditional method regarding the number of needle passes to complete the block placement.   "
40686|NCT02753062|"     This is an open-label, multi-center, prospective, single arm phase 2 trial of the combination     of bendamustine and rituximab in patients with PTLD, monomorphic cluster of differentiation     antigen 20(CD20) positive DLBCL. The investigators want to investigate the efficacy and     safety of the combination of bendamustine and rituximab in patients with previously untreated     PTLD, monomorphic CD20 (+) diffuse large B-cell lymphoma.   "
40664|NCT02753348|"     Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the     Copenhagen area 2016-2018.      Newborns are examined with echocardiography, electrocardiogram, measurements of oxygen     saturation and analyses of umbilical cord blood.      The main objectives of the baseline assessments in Copenhagen Baby Heart are to assess the     prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the     yield of routine echocardiography shortly after birth and to establish reference values for     echocardiography in Danish neonates.      Prospective follow-up of the birth cohort is planned with the purpose to assess the life-long     development of cardiovascular disease as well as other conditions and to study associations     between both pre- and postnatal exposure and disease, including life style, environmental and     genetic factors.   "
40665|NCT02753335|"     The intention of this trial is to investigate whether combined Graded Motor Imagery (GMI) and     Desensitization (D) among patients with CRPS is clinically more effective than only D and to     study changes in connectivity in the Default Mode Network before and after treatment.   "
40730|NCT02752490|"     The objective of this study is to determine if a strategy of indicated compared to liberal     oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is     that women who undergo a strategy of indicated compared to liberal oxygen administration in     labor will have lower rate of cesarean delivery and fetal acidemia at birth.   "
40896|NCT02750319|"     This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone     alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting     >30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days     after major thoracic surgery.   "
40666|NCT02753322|"     Stroke is one of the most common chronic disabling conditions in Hong Kong. People after     stroke may suffer from certain degree of physical impairment and disability. Resuming safe     ambulation in the community appears to be a big challenge to them as it always involves the     simultaneous performance of two or more tasks (dual task) such as walking and talking with     someone, walking and recalling the shopping list etc. Numerous studies has demonstrated that     the interference from dual tasks (dual task interference) may significantly impact the     recovery of the functional walking. To date, the relevance of dual task walking to daily     community is widely documented and the ability of managing dual task is therefore     particularly important. Evidences supported that dual task training showed its promising     effect on the balance and walking performance amongst people with neurological disorders,     such as chronic stroke. In light of this, the introduction of dual task based balance and     walking training into physiotherapy program for stroke patient may enhance the balance and     walking performance and hence promote successful community ambulation. Yet, there is limited     evidence on its effect in sub-acute stroke.      Objective: To examine the effectiveness of a dual-task based balance and walking training     program on performance and dual task interference in balance and walking ability, balance     self-efficacy and incidence of falls in people with sub-acute stroke   "
40667|NCT02753309|"     This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during     treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.   "
40668|NCT02753296|"     The aim of this research study is to develop a patient decision aid (PDA), and evaluate     whether its integration within oncology services enable cancer services to effectively     support and provide evidence based resources for women's fertility preservation decisions,     following a diagnosis of any cancer type.   "
40669|NCT02753283|"     The purpose of this research study is to find out if denosumab (Prolia®), an injection given     in the arm under the skin every 6 months, works to treat bone loss and prevent it from     worsening in older men and women (ages 65 and older) who have osteoporosis and reside in     long-term care (LTC) facilities.   "
40670|NCT02753270|"     Foam sclerotherapy has been established as another option of treatment for varicose veins of     the lower limbs. Its advantages are the application to patients with high surgical risk and     immediate return to usual activities. Comparing to laser and radiofrequency, it has lower     cost and is less painful. Nevertheless, it requires more re-interventions due to venous     recanalization.   "
40671|NCT02753257|"     Valtari Bio has early proof of concept clinical data of a multi-omic peripheral blood     biomarker profile that can be used to determine stroke from no stroke in the emergency     setting. The objective of this observational cohort clinical study is to determine the     clinical utility of this multi-omic biomarker profile.      Primary Study Aims:        1. The diagnostic tests characteristics of a multi-omic biomarker diagnostic for stroke          (ischemic stroke, transient ischemic attack (TIA) and hemorrhagic stroke) versus no          stroke (stroke mimic).        2. The ability of a multi-omic biomarker profile to differentiate ischemic stroke from          hemorrhagic stroke and TIA.   "
40672|NCT02753244|"     This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in     Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to     evaluate the effects of training on patients' cognitive performance   "
40673|NCT02753231|"     The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits     on hepatic metabolism and cardiovascular health as well as on selected physical fitness and     mental health outcomes among adolescent overweight/obese from Bogota, Colombia.   "
40674|NCT02753218|"     The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731     on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam     in healthy male subjects.   "
40675|NCT02753205|"     Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable     hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine     during laparoscopic lower abdominal surgery, might help to attenuate the increment of     intracranial pressure and the investigator would observe the optic nerve sheath diameter     using ultrasonography.   "
40710|NCT02752750|"     In this explorative longitudinal study 50 patients with Alzheimer's disease (AD) and 50     age-matched control subjects will be recruited for their 2 years follow-ups and undergo     extensive cognitive testing and quantitative 3 Tesla magnetic resonance imaging (MRI).     Regional differences of susceptibility and R2* relaxation rates in deep gray matter and the     neocortex will be evaluated in AD patients and controls and related to the patients´     cognitive status at baseline.   "
40711|NCT02752737|"     Cryo AF Global Registry a prospective, global, multi-center, observational Post-Market     Registry   "
40762|NCT02752074|"     The purpose of the study is to assess the efficacy, safety, and tolerability when combining     pembrolizumab with epacadostat or placebo in subjects with unresectable or metastatic     melanoma   "
40840|NCT02751047|"     The investigator will compare the feasibility of manual ventilation and pressure-controlled     mechanical ventilation during facemask ventilation in children. The hypothesis is that the     incidence of gastric insufflation would be lower during pressure-controlled mechanical     ventilation when compared to manual ventilation.   "
40712|NCT02752724|"     The purpose of this prospective randomized clinical trial is to determine if patients     receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT)     rather than standard of care will have improvement in symptoms of depression after a course     of ECT treatments. The investigators hypothesize that utilization of ketamine for induction     of general anesthesia during ECT treatments will improve symptoms of depression better, than     standard care.      This study is ONLY open to patients eligible to receive healthcare services through the     Department of Veterans Affairs at the VA Puget Sound, which means service in the active     military, naval or air service or separation under any condition other than dishonorable.     Qualifications for VA health care benefits can be found at va.gov.   "
40713|NCT02752711|"     To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying     children who are at very low risk of clinically-important traumatic brain injuries after     minor head trauma has not been validated prospectively in an independent population. Our goal     was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French     pediatric population in multiple clinical settings.   "
40676|NCT02753192|"     Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and     older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is     classically characterized by a symptomatic triad that includes rest tremor, akinesia and     hypertonia and although the motor expression of the symptoms involves mainly the limbs, the     muscles implicated in speech production are also subject to specific dysfunctions. Motor     speech disorders, so-called dysarthria, can thus be developed by PD patients. The main     objective of our project is to evaluate the physiological parameters (acoustics), perceptual     markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context     of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be     physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree     of impairment of such parameters should be associated with the pathology and be present     universally in all patients, even if they speak different languages; that should be also the     case of prosodic markers, whereas impairment of speech intelligibility may participate to the     psychosocial impact in communication alteration.      PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60).     Their global motor disability will be assessed with dedicated clinical rating scales, without     (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched     volunteers will provide the normal reference for between-group comparisons. Along with the     off and on medication clinical examinations, several speech tasks will be recorded. Moreover,     speech organ functions will also be assessed during the same examination. The psychosocial     impact of dysarthria will be evaluated via self-questionnaires; it will be analysed a     posteriori, as well as the speech intelligibility evaluation, and both will strengthen the     overall speech assessments. This global investigation will represent a unique opportunity to     provide the most precise and reliable description of PD patients' speech and its impacts on     intelligibility and quality of life. Challenging and interdisciplinary aspects are combined     in our project, which original cross-linguistic approach involves an international     collaboration definitely new in the field of motor speech disorders.   "
40677|NCT02753179|"     Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability     during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to     a severe impairment of their quality of life. However, correcting saccades during rapid head     movement, called covert-saccades, have been more recently identified. These saccades, which     occur during the head movement in patients with vestibular hypofunction, present a very short     latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease     oscillopsia and visual impairment. The objective of this study is to evaluate the potential     functional benefice of these compensatory movements in a population of 20 patients with     chronic bilateral areflexia, in a cross-sectional study.   "
40678|NCT02753166|"     To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours     following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the     periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and     emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin     conductance) in response cued reminders of the trauma; e) enhances the likelihood of     remission of PTSD symptom severity.   "
40679|NCT02753153|"     This study aims at assessing the hard and soft tissues remodelling of the alveolar crest     after extraction socket managements in the aesthetic areas:        -  3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at          the time of implant placement. (Outcomes 1: Hard tissues analyses )        -  Impressions, models and 3D analyses of the treated area allowed studying external soft          tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues          analyses )   "
40680|NCT02753140|"     Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in     locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab     with radiotherapy after neoadjuvant chemotherapy.      The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and     Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.   "
40681|NCT02753127|"     This is an international multi-center, prospective, open-label, randomized phase 3 trial of     the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus     standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer     (CRC).   "
40682|NCT02753114|"     Acute painful conditions make-up a large proportion of pre-hospital transports in British     Columbia (BC) yet Basic Life Support (BLS) paramedics have limited options to provide     analgesia and therefore adequate and timely pain relief is often significantly delayed.      Inhaled nitrous oxide is commonly used as a pre-hospital analgesic and is considered usual     care for pre-hospital providers in BC, but its utility in severe pain is uncertain.     Moreover, nitrous oxide is limited in its effectiveness by a short duration of action,     nausea, vomiting, and the necessity for patient cooperation.      IN Ketamine has been shown to provide rapid, easily-administered, and well-tolerated     analgesia in many settings. The investigators believe that the addition of IN ketamine to     usual care with nitrous oxide inhalation for adults experiencing moderate to severe intensity     acute pain in the pre-hospital setting will result in improved pain severity, improved     patient-reported comfort, and improved patient satisfaction.   "
40683|NCT02753101|"     Chronic pain can result from injured or inflamed nerves, as happens in people suffering from     sciatica and CRPS. These nerve injuries or regions of nerve irritation are often the cause of     pain in these conditions, but the current diagnostic tools have proven quite limited in     pinpointing these areas. Several studies have implicated involvement of sigma-1 receptors in     the generation and perpetuation of chronic pain conditions, while others are investigating     anti sigma-1 receptor drugs for the treatment of chronic pain. Using [18F]FTC-146, a sigma-1     receptor (S1R) detector and experimental radiotracer, and positron emission     tomography/magnetic resonance imaging (PET/MRI), we hope to learn the best approach to     identifying the site of nerve injury/inflammation (or other tissue injury/inflammation) as     they related to painful conditions, and, therefore, help identify the source of pain     generation. We will characterizing the disease in patients suffering from complex regional     pain syndrome (CRPS) and chronic sciatica, with the overarching goal of optimizing or     developing improved pain treatment regimens.      The broad objectives of this study are:        -  To determine the dosimetry of [18F]FTC-146        -  To evaluate the safety of [18F]FTC-146 after a single administration        -  To evaluate the pharmacokinetics and ability of the radiotracer to reflect S1R          expression in healthy subjects and specific patient subpopulations .      The study is not designed to induce any physiological/pharmacological effect.   "
40684|NCT02753088|"     The objective of the clinical study of the medicinal product for medical use: to compare     efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with     relapsing-remitting multiple sclerosis.      Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to     March 23, 2016.      Number of patients, involved into the study of the medicinal product for medical use: 158     patients.   "
40687|NCT02753049|"     This Mentored Patient-Oriented Research Career Development Award - (K23) seeks to provide the     advanced knowledge, skills, and experience for the candidate's career transition to an     independent nurse scientist. Her long term goal is to become a leading nurse scientist in     designing, implementing, and evaluating technology supported behavioral interventions     targeted for improved disease self-management (i.e. medication adherence, retention in care)     among human immunodeficiency virus (HIV)-infected, ethnic minority adolescents and young     adults. With an extensive background in pediatric HIV nursing and completed NIH funded pre     and post-doctoral interdisciplinary research traineeships, the candidate has begun to develop     the knowledge-base and skills necessary for this goal.      This award details a 3-year scope of mentored career development through which she will gain     the foundation for future research endeavors. Specifically, the goals of this proposal are     to: 1) conduct a novel research project under the mentorship of an interdisciplinary team of     expert researchers; 2) acquire expertise in health informatics for implementation of     technology supported behavioral interventions, health disparities, and advanced qualitative     and mixed methods design and analysis through firsthand experience, didactic interactions     with mentors, and graduate level coursework; 3) build a network of colleagues and     collaborators within New York University and elsewhere through this research and     participation at national and international meetings; and 4) prepare and submit a federal     research grant (R-21) based upon the skills and findings from this award period.      The specific research project through which she will accomplish these goals is a proof of     concept study, Adherence Connection for Counseling, Education, and Support (ACCESS), and     addresses the challenge of adherence to antiretroviral treatment among HIV-infected     adolescents and young adults. A mixed method design is proposed and the specific aims are to:     1) Characterize the feasibility and acceptability of a peer led, mHealth cognitive behavioral     intervention delivered via remote videoconferencing using smartphones; 2) Obtain initial     estimates of the biobehavioral impact of ACCESS on HIV virologic outcomes and self-reported     ART adherence, beliefs and knowledge about antiretroviral treatment, adherence self-efficacy,     and healthcare utilization (retention in HIV care). In summary, the ACCESS adherence     intervention is consistent with the National Institute of Nursing Research (NINR) call for     the development of novel interventions to deliver personalized care and real-time health     information for patients.   "
40688|NCT02753036|"     Neurotoxic phenomena are among the most common and difficult to treat side effects of     chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a     well-recognized adverse reaction in the peripheral nervous system. Side effects of     chemotherapy in the central nervous system, however, particularly changes of cognitive     function (in non-medical literature referred to as chemobrain) are diffuse and difficult to     attribute to individual cytostatic drugs. The primary purpose of this study is to assess     cognitive function in patients with ovarian and breast cancer before and after systemic     chemotherapy with paclitaxel with standardized neuropsychological tests and compare the     outcome to patients with benign gynecological tumors and breast cancer without chemotherapy     treatment, respectively. Secondary parameters include the assessment of olfactory function,     total neuropathy score and cytokine profiles.   "
40689|NCT02753023|"     Critical patients in emergency room are seriously situations that need quickly diagnosis and     treatment. Different predictors of prognosis can be related with mortality and morbidity     in-hospital and in long-term. In Brazil, this kind of registry is not available. The aim of     the study is analysis and report data about critical patients in Emergency Departments over     all country, showing demographic, clinical and prognosis data about that in Brazil.   "
40690|NCT02753010|"     The gastric emptying of 400 ml 12.6% carbohydrate rich drink is investigated in elderly     women, age 75-100, with acute hip fracture. The emptying time will be assessed by the     paracetamol absorption technique, and lag phase and gastric half-emptying time compared with     two gender-matched reference groups: elective hip replacement patients, age 45-71, and     healthy volunteers, age 28-55.   "
40691|NCT02752997|"     Patients admitted for heart failure that are provided discharge medication services by a     pharmacist are less likely to be readmitted within 30 days of primary admission.   "
40692|NCT02752984|"     Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally     Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why     DVT develops.   "
40693|NCT02752971|"     The infiltration of the surgical wound is an effective strategy for postoperative analgesia.     Nonsteroidal antiinflammatories are useful in this way.      Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or     bupivacaine plus diclofenac sodium infiltrating wound appendectomies.      Method: Comparative, double blind, American Society Anesthesiologist classification     I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3     (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic     consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.   "
40694|NCT02752958|"     This multicentre, non-comparative design study will monitor the impact of long term     management of DH with daily use of a sensitivity toothpaste on the quality of life of a     population of sensitivity sufferers. Changes in oral health related quality of life will be     monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will     be conducted in participants in good general health, with pre-existing self-reported and     clinically diagnosed tooth sensitivity at screening.   "
40695|NCT02752945|"     This is a feasibility trial designed to test the feasibility and acceptability of a one-day     Cognitive Behavioural Therapy (CBT) workshop intervention (DISCOVER) for young people aged     between 15-18 years, who are on local child and adolescent mental health services (CAMHS)     waiting lists, awaiting treatment for difficulties with anxiety and/or depression.     Participants will be randomised to receive either the DISCOVER workshop (in addition usual     care) or to continue usual care.   "
40696|NCT02752932|"     Primary objectives:        1. Evaluate the feasibility of rapidly accruing 30 participants with recurrent metastatic          head and neck squamous cell carcinoma for the development of patient derived xenographs          (PDX) from fresh, real time biopsies in which sensitivity to < 4 Ontario funded          chemotherapeutic regimen will be tested. Written feedback to the primary oncologist will          be provided.        2. There is also a curative intent cohort of 30 participants undergoing surgical resection          with curative intent. These PDX models will undergo exome sequencing with written          feedback.        3. Feasibility in both surgical and recurrent cohorts will be a measure of i) engraftment          rate, ii) patient status at the time of drug testing completion and iii) rate of          accrual.   "
40697|NCT02752919|"     The study involves a single dose of galunisertib taken by mouth by Japanese participants and     non-Japanese participants. The study will evaluate the relationship between the effect of the     study drug on the electrical activity of the heart, as measured by electrocardiogram (ECG)     and how much of the study drug gets into the blood stream and how long it takes the body to     remove it. Ths study will last about 42 days for each participant.   "
40725|NCT02752555|"     This study is the first to evaluate the effect of oral supplementation with antioxidants     combined with lifestyle modification for severe male factor partner of couples undergoing     ICSI.   "
40698|NCT02752906|"     The aim of the study is to describe the safety and antibody response to revaccination with     MenACYW conjugate vaccine in persons who received their first quadrivalent meningococcal     conjugate vaccine dose at ≥ 10 years of age.      Primary Objective:        -  To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal          serogroups A, C, Y, and W following the administration of a booster dose of MenACYW          conjugate vaccine compared to those observed following the administration of a booster          dose of a licensed Meningococcal Conjugate Vaccine (MCV4) in subjects who were first          vaccinated with 1 dose of MCV4, 4 to 10 years before the booster dose.      Secondary Objectives:        -  To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured          using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after          vaccination in a subset of subjects        -  To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W          measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination      Observational Objectives:        -  To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured          by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination        -  To describe the safety profile of MenACYW conjugate vaccine compared to that of a          licensed MCV4 after booster vaccination.   "
40699|NCT02752893|"     The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate     novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor     receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop     novel treatment strategies and dissect signaling pathways underlying drug sensitivity and     resistance.   "
40700|NCT02752880|"     Type 2 diabetes mellitus is a chronic metabolic disease that seriously affects patients     worldwide, and it is always among the top 10 causes of death in Taiwan. To date, still many     patients who take more than three kinds of oral hypoglycemic agents could not effectively     control their glycohemoglobin levels in clinics. Hypoglycemia as well as weight gain are     common side effect with insulin therapy, and many patients in Taiwan are not willing to     receive insulin injection. It is common for diabetic patients treated with Chinese herbal     medicine in China currently, and some therapeutic effects have been published in     international journals. In this study, we will evaluate whether Chinese herbal medicine, YH1,     enhances the glycemic control and is safe as add-on medication in poorly controlled type 2     diabetes patients.      A total of 80 poorly controlled type 2 diabetes patients with glycohemoglobin ≥ 9% from     Endocrinology and Metabolism clinics or Internal Chinese Medicine clinics will be enrolled in     this randomized double-blind placebo-controlled trial. Subjects will be randomly assigned to     receive either YH1 (6 g) or the placebo three times per day for 12 consecutive weeks. All     subjects in both groups will also continuously receive their oral hypoglycemic agents without     any dose or medicine change. During this 12-week period, the glycohemoglobin, fasting plasma     glucose, 2h postprandial glucose, waist circumference, body weight, and body mass index will     be assessed. In addition, insulin resistance, β -cell function, lipid profile, liver and     renal function will also be evaluated. Independent statisticians will perform the data     analysis at the end of the trial.   "
40701|NCT02752867|"     The purpose of this study is to explore the pathogenesis of cognitive impairment after acute     cerebral infarction by applying the multimodal function MRI to dynamically observe the     changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of     the brain ,and to provide a visual instrument for evaluating the therapeutical effects of     Chinese medicine through the application of multimodal function MRI to observe the changes of     the neurotransmitter in certain area in the brain before and after the treatment.   "
40702|NCT02752854|"     one measurement of pain threshold in high altitude and in low altitude using pressure     algometer and Situational pain scale.   "
40703|NCT02752841|"     Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney     stone burden in calcium kidney stone formers   "
40705|NCT02752815|"     This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed     by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in     the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.   "
40706|NCT02752802|"     The purpose of this study is to evaluate the amount of contrast media (CM) saved using the     DyeVert system in diagnostic angiographic procedures compared to a control group.   "
40707|NCT02752789|"     This is a multi-center, prospective, single cohort, observational study of pediatric heart     transplant recipients designed to determine the impact of preformed versus de novo human     leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens     cardiac myosin and vimentin, on chronic allograft function. In addition, the investigators     will explore mechanisms of action and predictors of DSA, rejection and altered     pathophysiology.   "
40708|NCT02752776|"     Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis patients     with or without prior exposure to systemic therapy.   "
40709|NCT02752763|"     Dry eye is a significant adverse effect of isotretinoin causing patients to use ophthalmic     medications. For this reason, many patients using isotretinoin are referred to ophthalmology     clinic because of discomfort symptoms. In the literature, there are studies suggesting     superiority of Autologous serum drops regarding effects on ocular surface when compared to     artificial tear. In addition, Autologous serum was also used in several corneal pathologies     with successful outcomes. No data regarding use in the ocular adverse effects of isotretinoin     was found in the literature; however, investigators think that it may be an effective     alternative in the treatment of dry eye developed during isotretinoin use due to positive     effects on ocular surface, epithelial regeneration and anti-inflammatory effect. Autologous     serum can be a choice of ophthalmologists in routine practice by increasing number of     comprehensive studies investigating effectiveness, safety and long-terms effects of     Autologous serum therapy.In this study, it was aimed to investigate dry eye development in     the patients receiving systemic retinoic acid therapy and to compare effectiveness of     Autologous serum and Preservative free artificial tear in the patients with dry eye disease.   "
40767|NCT02752009|"     This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure     in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who     have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant     therapy).   "
40715|NCT02752685|"     This is a single-arm open-label multi-cohort Phase II study evaluating the     safety/tolerability and clinical activity of the combination of nab-paclitaxel and the     antibody against programmed cell death 1 (PD-1), pembrolizumab, in patients with human     epidermal growth factor receptor (HER-2) negative metastatic breast cancer (n=50). There will     be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort with     30 subjects and a hormone receptor (HR)-positive cohort with 20 subjects. There will be an     initial safety run-in with 12 subjects from the TNBC and HR-positive cohort (~ 6 patients     from each cohort). If no unexpected toxicity is observed (as defined in the study protocol),     then enrollment will continue to complete both cohorts (30 total TNBC, 20 total in HR     positive cohort). The subjects from the run in safety part will be included in the Phase II     analysis. Tumor expression of programmed cell death ligand 1 (PD-L1) is not required for     enrollment in the study, but will be assessed as possible predictive marker.   "
40716|NCT02752672|"     Dithranol (known in the U.S.A. as anthralin and in Germany as cignolin) is one of the oldest     and safest topical anti-psoriatic treatments. However, despite explorative investigations,     the skin disease-clearing mechanisms of dithranol remain poorly understood (Painsi et al,     JDDG 2015). The purpose of this study is to investigate the therapeutic mechanisms of     dithranol in psoriasis.   "
40717|NCT02752659|"     Early detection and treatment of onset or worsening of breast cancer-related lymphedema     (BCRL) can potentially prevent or postpone the condition to progress into a chronic     progressive condition or eliminate the risk of infections in the arm (cellulitis).     Self-surveillance for BCRL by routinely measuring own arm circumference could potentially     enable early detection of onset or worsening of lymphedema. The aim is to determine whether     women who have received surgery for breast cancer, can perform self-measures of arm     circumference in a reliable and valid manner using written and video supported instructions     without in-person teaching by a physiotherapist.   "
40718|NCT02752646|"     This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs     ketorolac 0.5% among patients undergoing cataract surgery.   "
40719|NCT02752633|"     This exploratory pilot study was an open-label, crossover, single-center and non-randomized     clinical trial designed to compare the effect of the standardly employed doses of allopurinol     (400 mg/day) and febuxostat (80 mg/day) on the urinary 2,8-dihydroxyadenine (DHA) excretion     in patients with adenine phosphoribosyltransferase (APRT) deficiency.   "
40720|NCT02752620|"     This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment     of subjects with chronic nonspecific low back pain.   "
40721|NCT02752607|"     Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and     pulmonary embolism (PE), is the third most common cardiovascular disorder after myocardial     infarction and stroke. VTE occurs in about 1 person per 1,000 per year, increasing     dramatically in patients with cancer to about 25 per 1,000 per year. Among the known risk     factors of VTE, cancer is one of the most potent. Patients with cancer have a 7- to 28-fold     higher risk for VTE than non-cancer patients. VTE has important implications for the care of     cancer patients, including reduced life expectancy, high rates of VTE recurrence both while     on and after stopping anticoagulation, the need for chronic anticoagulation with related     adverse drug reactions, and delays in cancer therapies. Clinical dilemma: Current clinical     guidelines recommend a minimum of 3-6 months of anticoagulation with weight-adjusted low     molecular weight heparin (LMWH) in cancer patients with VTE. However, there are no     recommendations beyond the initial 6 months of therapy due to the lack of data on extended     duration therapy for cancer-associated thrombosis (CAT). This leads to variability in     physician practices, with some continuing weight-adjusted LMWH therapy beyond 6 months. This     poses concern because, while the goal is to prevent recurrence of VTE, the risk of major     bleeding with prolonged weight-adjusted LMWH therapy is significant. Potential solutions:     There is a lack of data to inform on VTE treatment in cancer patients beyond the initial 3-6     months of anticoagulation. We propose that after a minimum of 3-6 months of therapeutic dose     anticoagulation, the use of prophylactic doses of LMWH will have an acceptable and adherence     profile in cancer patients with VTE. The data obtained from this study will help inform     physician practices. Design: This is a multicentre, open-label study of enoxaparin (40 mg     subcutaneous injection, once daily) for additional 6 months after an initial minimum     3-6-month course of therapeutic dose anticoagulant therapy. Patients: 150 patients with VTE     secondary to cancer will take part in this multicentre study conducted in 8 Canadian centres     within Quebec, Ontario and Nova Scotia. Study Outcomes: The primary objective of the study is     to determine the rate of recurrent VTE in patients receiving prophylactic dose enoxaparin for     secondary VTE prophylaxis after an initial minimum 3-6 months of anticoagulation. The     secondary objective is to determine the safety profile of prophylaxis dose enoxaparin for     secondary VTE prophylaxis after an initial 3-6 months of anticoagulation. This includes     determining for all subjects: 1) cumulative incidence of major bleeding events; 2) cumulative     incidence of clinically relevant non-major bleeding events; 3) cumulative incidence of minor     bleeding event, and 4) overall survival during follow-up.   "
40722|NCT02752594|"     Dental caries is a multifactorial disease effecting majority of the human population.One of     the etiological factor causing dental caries is salivary mutans streptococci. Reducing the     levels of this bacteria in the saliva can significantly reduce the incidence of dental     caries. A non-invasive intervention, such as the administration of probiotics reduced the     salivary mutans streptococci levels.   "
40723|NCT02752581|"     The study was designed to investigate efficacy of suction drains in arthroscopic knee     surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were     randomised, and suction drain was applied to one group, and the other group as the control     group without a suction drain.   "
40724|NCT02752568|"     300 recurrent implantation failure patients will be alternatively assigned to assisted     hatching , endometrial scratch , and no treatment ,100 patients in each group   "
40726|NCT02752542|"     Depression currently affects close to 2 million Canadians and is the leading cause of     disability worldwide. Pharmacological treatments (antidepressant medication) and     psychological treatments such as cognitive-behavioural therapy are available for depression,     but the majority of those who receive treatment have an unsatisfactory response. On average,     the combination of pharmacological and psychological treatment achieves better results than     either treatment alone. However, the apparently superior results of combination treatment may     be due to the fact that different individuals preferentially respond to pharmacological or     psychological treatment. The invesitagtors have discovered several clinical factors and     biomarkers that predict poor response to commonly used antidepressant medication: history of     childhood maltreatment, loss of interest and reduced activity, a biomarker of systemic     inflammation, and a genetic marker of sensitivity to environment. Indirect evidence suggests     that the same factors may indicate the need for psychological treatment, but their usefulness     as differential predictors of psychological and pharmacological treatment outcomes remains to     be established.      The investigators will test the hypothesis that a pre-determined set of clinical variables     (history of childhood maltreatment, loss of interest and reduced activity) and biomarkers     (serum C-reactive protein, a marker of systemic inflammation, and short alleles of the     serotonin transporter gene promoter polymorphism) differentially predicts response to     antidepressants and to cognitive-behavioural psychotherapy with clinically significant     accuracy.      If this hypothesis is supported, the resulting predictor will allow personalized selection of     treatment for depression, leading to improved outcomes and healthcare efficiency. Additional     objectives include replication of additional predictors and integrative analyses aimed at     refining the treatment choice algorithms.   "
40727|NCT02752529|"     Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of     Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and     build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506     metabolic differences.   "
40768|NCT02751996|"     This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study     with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus   "
40731|NCT02752477|"     The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)     technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce     postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery     when compared with traditional opioid-containing techniques. It is expected that this OFA     regimen will have a measurable reduction on postoperative opioid consumption and pain scores     in CPPs.   "
40732|NCT02752464|"     Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including     cardiovascular disease, diabetes, and obesity-related cancers.The successful management of     overweight/obesity requires management of nutrition and physical activity over time. For     racial/ethnic minority and low-income populations, who face both higher prevalence of obesity     and chronic diseases compared to others, interventions promoting behavioral change are a     national health priority. From the available range of behavioral change intervention     strategies, there is a growing knowledge base that documents the efficacy of peer support     interventions for improving self-care, quality of life, and behavioral change. In this study,     the investigators will examine the following research question: What is the preliminary     efficacy and degree of implementation and acceptability of an intervention approach in which     peer counselors provide evidenced-based counseling about nutrition and physical activity     behaviors for weight management to public housing residents using a computer-assisted program     called CuesWeight?   "
40733|NCT02752451|"     Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy     skills after receiving prior training with different simulation systems.   "
40734|NCT02752438|"     Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive     to conventional mechanical ventilation both in children and newborns, there is no data on its     success and the factors that affect its success in the literature.   "
40735|NCT02752425|"     Speech is a privileged means of communication for humans: its trouble can thus prove being     extremely handicapping. Standard speech therapy is limited in some cases by the lack of     sensory feedback available to the patient (hearing, surgery, neural damage, etc.).      The present study aims at quantify the contribution of the tongue articulatory visual     feedback offered by ultrasound echography to speech trouble rehabilitation.      Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and     10 childrens with important speech troubles due to central nervous system damage.      The principle is to conduct standard speech therapy sessions, alternating series of sessions     with the use of visual feedback and sessions without visual feedback.      The progress will be regularly measured by means of standard batteries of speech articulation     tests.   "
40737|NCT02752399|"     The purpose of this study is to verify the applicability Six minutes walk test and Shuttle     walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Patients     will undergo three functional tests, being the six-minute walk test, shuttle walk test and     cardiopulmonary exercise test on a cycle ergometer, associated with evaluation of metabolic     and ventilatory variables and cardiac monitoring throughout the test.   "
40738|NCT02752386|"     The purpose of this study is to test whether a novel form of biofeedback training can help     individuals regulate their pain more effectively.   "
40739|NCT02752373|"     This is an open label prospective study of the impact on healthcare utilization of a surface     Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic     (GTC) Seizures.   "
40740|NCT02752360|"     Intestinal anastomosis plays an important role in various general surgeries, but the     complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided.     Although many ways are put up to solve this problem, there are still many imports need to     improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal     anastomosis easily and less complications, have been produced.The major goal of this study is     to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in     surgery of intestinal anastomosis.   "
40744|NCT02752308|"     From September 2014 to March 2015, 57 consecutive patients with hypospadias who are candidate     for surgery will be enrolled in this randomized clinical trial.      Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of     the study and all parents will sign a written informed consent.      Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity.     Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection ,     parents' disagreement with the protocol and any cardiac problem that made epinephrine     injection contraindicated.      All selected patients will randomly allocate to one of the two groups: group A will receive     caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive     general anesthesia before surgery and CEB afterwards. The surgical procedures will be     performed by a single pediatric urologist (FA). The surgical technique will be tubularized     incised plate in all cases.      Intraoperative blood loss will be determined by weighing all surgical gauzes used during     procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to minimize     the effect of water vaporization on gauzes weights.      In addition to blood loss, operation time, dose of fentanyl used during procedure and length     of the urethral plate defect will be recorded for each patient by trained nurses.      Demographics and disease characteristics as well as operation details will be compared in the     two studied groups.   "
40745|NCT02752295|"     This study intents to determine who will benefit from an intensive brief stress coping     intervention week (ISCIW) as secondary prevention for real world affective disorder patients.   "
40746|NCT02752282|"     This study is a counseling intervention for new LNG-IUS users. The study explores the use of     video technology to deliver anticipatory counseling on LNG-IUS side-effects, adjustment     periods and bleeding changes to women newly using the LNG-IUS for contraceptive purposes. The     primary aim is to understand if anticipatory counseling delivered via video can increase     LNG-IUS satisfaction and continuation of the device in the first 6 months of use.   "
40782|NCT02751814|"     Objective is to examine the physical activity and screen-time behaviors of children enrolled     in licensed childcare centers before and after the enactment of new state regulations.   "
40898|NCT02750293|"     Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per     day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint   "
40747|NCT02752269|"     According to the literature available pulmonary hypertension is present in 12 to 23% of     patients suffering from Sjögren Syndrome. However epidemiological data are based on     non-invasive measurements using echocardiography. Furthermore, no data are available     regarding exercise hemodynamics in those patients.      This study investigates pulmonary hemodynamics at rest and during exercise in patients     suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary     hypertension (PH) will be offered further investigations including right heart     catheterization.   "
40748|NCT02752256|"     Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during     air ambulance transfer   "
40749|NCT02752243|"     Multi-site, non-randomized Phase I/II study involving children and adults.   "
40750|NCT02752230|"     This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine     0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of     this study is to evaluate two local anesthetics and determine if there is an advantage of     administering one medication compared over the other. The intent is show that one local     anesthetic.allows for improved pain control as per the pain scale ratings of the test     subjects.   "
40751|NCT02752217|"     Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory     pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung     function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in     elderly with Isolated systolic hypertension.   "
40752|NCT02752204|"     The aim of this clinical trial is to see if the drug called AZD2014 is effective and safe to     use to treat patients with relapsed or refractory Diffuse Large BCell Lymphoma (DLBCL). The     trial will also be looking at combining the antibody (Rituximab) with the drug AZD2014 in a     small number of patients to see if this can be done without increasing the toxicity. 36     patients will be recruited to the trial. 30 will receive AZD2014 alone and the remaining 6     will receive AZD2014 plus rituximab. AZD2014 will be given as a 125mg tablet that is to be     taken twice a day for 2 days out of every 7 (i.e. on days 1 and 2 of every week). Rituximab     will be given via IV infusion on day 1 of every 28 days (once every 4 weeks) for a maximum of     6 cycles.   "
40753|NCT02752191|"     The standard clinical cardiovascular MRI practice for children with CHD frequently involves     the use of gadolinium-based contrast agents (GBCA) to enhance tissue contrast. Most GBCAs are     small molecules that quickly cross the capillary wall and access the interstitial space, a     process which diminishes the signal contrast between blood vessels and surrounding tissue.     Therefore, these types of GBCA are most useful for first-pass MR angiography, wherein the     images are acquired quickly during the initial 15-30 seconds post-injection when the GBCA     concentration is much higher in the arteries than in the interstitial space. For young     children with complex CHD, the stringent requirements for high spatial resolution, and the     need for cardiac gating and good blood-myocardium contrast in order to provide detailed     evaluation of intracardiac structures are not compatible with conventional GBCA-based     first-pass MR angiography. Even with Ablavar® (gadofosveset trisodium), an FDA approved GBCA     with longer intravascular half-life than other GBCAs, cardiac-gated Ablavar®-enhanced MRI may     be insufficient for young children with CHD based on our institutional experience and on data     from the literature; there remains diminished blood-tissue contrast during the     high-resolution cardiac-gated MRI. Furthermore, there have been safety concerns regarding     gadolinium deposition in brain tissues after repeated GBCA exposure as well as concerns of     nephrogenic systemic fibrosis (NSF) associated with GBCA injection in young children < 2     years old who may have immature renal function. The long-term health consequences of these     effects in the pediatric population are unclear. For the above reasons, we seek to study the     diagnostic imaging effectiveness of Feraheme (Feraheme®), an FDA-approved drug for parenteral     iron supplementation, as an MRI contrast agent in children with CHD. Although Feraheme® has     been approved for the treatment of iron deficiency anemia secondary to renal disease,     Feraheme® has been used as an off-label MRI contrast agent at select medical centers.   "
40763|NCT02752061|"     Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity     and mortality between low- and middle- income countries (LMICs) and high-income countries.     Individuals present with advanced stage disease resulting in minimal chance for cure or     long-term survival.      The Potlako project will implement and evaluate a multifaceted intervention to test the     hypothesis that a package of enhanced coordination of care including an electronic messaging,     transportation support, and training targeted at generalist clinicians at primary and     secondary level facilities, can reduce time to diagnosis and stage at diagnosis for     HIV-infected individuals with cancer.   "
40764|NCT02752048|"     The objective of this study is to evaluate the efficacy after 24-week repeated oral doses of     TAS-205 in patients with Duchenne Muscular Dystrophy (DMD) in an exploratory manner.   "
40754|NCT02752178|"     This is a study to characterise the role of inflammatory processes in depression. There is     compelling evidence that inflammation is often associated with, and can cause, depression. It     is currently less clear that antiinflammatory drugs have meaningful antidepressant effect.     One of the goals is to identify the subset of depressed patients that is most likely to     respond better to an antiinflammatory drug than to a conventional antidepressant. The     investigators will therefore undertake a study of patients with a diagnosis of major     depressive disorder including four groups: i) incompletely responsive patients who have     demonstrated failure to respond consistently or completely to standard treatment, ii) those     who have responded well to treatment and are not currently depressed, iii) untreated patients     who are currently depressed, iv) healthy volunteers with no history of depression.     Participants will undergo a clinical assessment, an interview with a trained member of the     research team and will complete self-rated questionnaires. Investigators will collect blood     and saliva samples to measure certain immune markers. They will also perform magnetic     resonance imaging (MRI) scans to look for MRI markers in the brain and investigate brain     inflammation in a subsample of these patients using positron emission topography (PET) and     cerebrospinal fluid (CSF) sampling (also called lumbar puncture).   "
40794|NCT02751645|"     The investigators primary objective is to determine if acute normovolemic hemodilution (ANH)     for pediatric cardiac surgical patients decreases the volume of blood products transfused     during surgery and the immediate post-operative period as compared to usual care. This study     will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing     either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for     the use of cardiopulmonary bypass.   "
40795|NCT02751632|"     A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a     step-wise clinical approach for the treatment of ultra high risk patients and reduction of     risk for psychosis and other deleterious clinical and/or functional outcomes.   "
40755|NCT02752165|"     In the US, children from minority ethnic and racial backgrounds suffer disproportionately     from asthma and account for substantially more emergency department (ED) visits and     hospitalizations than non-minority children. While NHLBI guidelines recommend daily     preventive medications for all children with persistent asthma to prevent morbidity as well     as ED visits and hospitalizations, many children who should receive preventive medications     are not receiving them. This is in part because children presenting to the ED for an acute     asthma exacerbation rarely receive preventive asthma care, due to the ED's focus on acute,     episodic care. The NHLBI guidelines recommend that children follow-up with a primary care     provider (PCP) within 1-4 weeks of the ED visit. The post-ED follow-up visit is an     opportunity for the PCP to prescribe effective preventive asthma medications, step-up     medication for children who demonstrate poor control, promote adherence, and provide     education on asthma self-management and trigger control. However, rates for follow-up after     an asthma-related ED visit are extremely low, and preventive care is delivered inconsistently     even when children are seen in follow-up. In the investigators' prior work they have found     that a provider prompting intervention can enhance the delivery of guideline-based preventive     asthma treatments at the time of a primary care office visit and ultimately reduce morbidity.     They have also found that telemedicine can link children with persistent asthma to a provider     for optimal chronic illness management. The goal of this project is to use a novel     telemedicine-based program to facilitate primary care follow-up and promote the delivery of     guideline-based preventive care for high-risk children presenting to the ED for an asthma     exacerbation. The investigators will utilize a 2-group randomized trial to test the TEAM-ED     intervention. The intervention includes: 1) a telemedicine assessment at the child's school     within one week of discharge from the ED and completed by a PCP, 2) 'point-of-care' prompting     to promote the provision of guideline-based preventive care during the telemedicine visit,     and 3) two additional telemedicine-assisted follow-up assessments to assure optimal response     to treatment and tailor the care regimen as needed. The investigators will assess the     effectiveness of the program in reducing respiratory morbidity and improving preventive     asthma care, with follow-up assessments at 3, 6, 9, and 12 months.   "
40756|NCT02752152|"     The primary objective of the study is to evaluate and compare, in at-risk populations, the     efficacy of three different counseling methods in terms of propensity to come back for a HIV     re-test. Secondary objectives are to evaluate and compare the efficacy of the counseling     methods in terms of reported risk behavior and HIV knowledge as well as their acceptability     and cost-effectiveness, describe the distribution of duration from HIV primary infection to     detection, and estimate the prevalence of chronic hepatitis B and C, and syphilis in     HIV-uninfected participants of targeted populations.   "
40757|NCT02752139|"     The purpose of this study is to determine the relationship between sleep disorders and     cerebral hemodynamics.   "
40758|NCT02752126|"     A randomized phase II study of palliative radiation of advanced central lung tumors with     intentional avoidance of the esophagus. Patients will be randomized between standard of care     palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy     (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following     randomization and subjects will be followed for 1 year after completion of their radiation     therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal     Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).   "
40759|NCT02752113|"     Diabetes mellitus is a wide-spread disease accompanied by strongly increased morbidity and     mortality due to micro- and macrovascular complications. However, in studies with patients     suffering from diabetes mellitus type 2 (DM 2), early changes and impairments in large and     small blood vessels as well as organ damage (e. g. to the kidneys) have been only     insufficiently investigated (1). The newest substance class in oral antidiabetics, i. e.     SGLT-2-inhibitors (such as empagliflozin) cause an increased renal excretion of glucose. In     addition, the concurrent increased sodium excretion brings about an improvement of vascular     function and thus a decrease in blood pressure. In the EMP-REG-OUTCOME study (2), the     cardiovascular mortality rate was significantly lower in the empagliflozin group (3.7% versus     5.9%; 38% relative RR) compared to placebo.For another new substance class, the     dipeptidylpeptidase-4-inhibitors, a number of pleiotropic effects have been described (3). In     one of our recently conducted trials, we could demonstrate a positive effect of linagliptin     on renal an inflammatory parameters compared to placebo (4). Thus, the combination of both     substance classes with regard to positive effects on micro- and macrocirculation, even though     not sufficiently proven as yet, suggests itself. The therapy with metformin and long-acting     insulin (BOT), as well as a twofold oral medication is possible according to the     recommendations of the Deutsche Diabetes Gesellschaft (DDG) and the positional paper of the     American Diabetes Association (ADA). Accordingly, the aim of the present paper is the     analysis of the effects of a combined therapy with empagliflozin plus linagliptin compared to     metformin plus insulin glargine on renal and vascular changes in type 2 diabetes mellitus.   "
40760|NCT02752100|"     Along with the improvement of living standard, the prevalence of Lower extremity arterial     occlusive disease (LEAOD) is also increasing, which has become an important cause of lower     extremity amputation and greatly affected the patients' life quality. Currently, percutaneous     transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been     regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects     of lower extremity interventional treatment, varied in different reports. It was reported     that the therapeutic effects were influenced by some traditional risk factors, including age,     gender, smoking, and so on. More risk factors are still unknown. The difference of     therapeutic effects, the endpoint events were compared between interventional and     conventional treatment group to analyze the effect of interventional treatment on LEAOD and     explore its risk factors.   "
40761|NCT02752087|"     This study of healthy participants will evaluate the concentration of a test LY900014 and a     reference LY900014 formulation in the bloodstream and how it affects the blood sugar levels.     The whole study, including screening, will take up to 8 weeks to complete.   "
40766|NCT02752022|"     Electronic cigarettes (e-cigarettes) have proved very popular and a meteoric rise in their     usage is currently under way. People purchase them as an aid to giving up smoking, to reduce     cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban     smoking, and in order to continue smoking with decreased health risks. Although the safety     and impact on health of electronic cigarettes, especially after long-term use, has not been     evaluated, they are generally considered to be far safer alternatives to cigarette smoke.     Electronic cigarettes do not generate polycyclic aromatic hydrocarbons, a potent class of     carcinogenic chemicals generated during the combustion of tobacco and making important     contribution to the cigarette-induced cancer. However, carcinogenic tobacco-specific     nitrosamines have been encountered in e-cigarettes being detected in some nicotine cartridges     as contaminants, albeit at very low concentrations in comparison with tobacco smoke.     Consequently, it is imperative to ascertain the toxicity risk (if any) of consuming nicotine     intake through electronic cigarettes. This European Commission funded study will monitor     levels of carcinogenic tobacco-specific nitrosamines in urine of heavy smokers who give up     smoking and completely transition to e-cigarette use for a period of 4 weeks. Levels of other     compounds which are known to be associated with smoking toxicity, such as DNA adducts and DNA     methylation, will also be monitored in biological fluids of these subjects. Finally,     cigarette craving, mood, anxiety, social anxiety, well-being status and stress hormones will     be measured in smokers transitioning to e-cigarettes for 4 weeks to assess the psychological     effect of the transition. The results from the study will provide important information on     the safety and effectiveness of e-cigarettes for smoking cessation which investigators     anticipate to drive policy.   "
40769|NCT02751983|"     An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public     health policy both call for treatment targeting high-risk populations, such as Veterans     hospitalized due to suicidal intent and/or attempts. Psychiatric hospitalization is a     critical opportunity to provide treatment to reduce the risk of suicide and lay the     groundwork for functional recovery. Yet, there are no interventions specifically for suicide     prevention that meet Veterans Health Affairs' quality recommendations requiring the provision     of evidence-based, recovery-oriented psychotherapy, which are also feasible to use during a     typical inpatient stay. The proposed study seeks to take a first step toward filling this     gap. In consultation with experts in the field, the authors have developed a protocol     applying a recovery-oriented, evidence-based treatment approach to Veteran inpatient care.     The proposed pilot study will provide critical information to inform final revisions of the     treatment manual and research design for a future study evaluating the efficacy of the     intervention.   "
40770|NCT02751970|"     This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive     systems by retention rate of resin restorations placed in non carious cervical lesions with     four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1     step self-etch adhesive systems.   "
40771|NCT02751957|"     This Mentored Career Development Award will lay the foundation for a career focused on     addressing 2 specific Grand Challenges in Global Mental Health priorities: 1) improving child     access to evidence-based mental health care, and 2) reducing the duration of untreated     illness by developing culturally-sensitive early interventions. The proposed research aims to     assess the acceptability, feasibility, and impact of a brief caregiver-mediated early autism     intervention adapted for use in a low resource setting. Data from this pilot study would     inform scalable early autism intervention programs for implementation in underserved, low     resource, and low-literacy populations globally.   "
40772|NCT02751944|"     This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell     membrane versus placebo in reducing exercise-induced joint pain & stiffness & cartilage     turnover in healthy post-menopausal women. Half of the study participants will receive NEM,     once daily, orally while the other half of the study participants will receive placebo, once     daily, orally.   "
40773|NCT02751931|"     A study to evaluate the efficacy, safety and tolerability, and pharmacokinetics of mirabegron     after multiple-dose administration in the pediatric population.   "
40774|NCT02751918|"     Anetumab ravtansine is developed for the treatment of patients with recurrent     platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the     maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated     liposomal doxorubicin in this indication.   "
40775|NCT02751905|"     The primary objectives of the study are: To determine the mass balance and routes of     elimination of BIIB074 and its known metabolites following administration of a single oral     dose of BIIB074 in healthy male participants and To describe the pharmacokinetics (PK) of     BIIB074 and its known metabolites and the disposition profiles of total radioactivity in     whole blood and plasma following a single oral dose. The secondary objectives of this study     are: To assess the safety and tolerability of BIIB074 in healthy participants and To identify     and characterize any additional metabolites of BIIB074 in plasma, urine, and feces.   "
40776|NCT02751892|"     Long-term maintenance of physical activity behaviour change post-intervention remains     challenging. This study is investigating the feasibility of a behaviour change intervention     based on Self-Determination Theory in people recovering from colorectal cancer and its     effects on behaviour change 6 months post-intervention.   "
40777|NCT02751879|"     This is a non-interventional, multi-country, multi-site study based on existing data from     medical records of patients treated with Gi(l)otrif® as part of the routine treatment     according to the approved label. Data from real-world will help to understand if dose     modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and     effectiveness are as in trial settings. Furthermore, data on modified starting doses, the     underlying reasons and effects on safety and outcome are needed.   "
40778|NCT02751866|"     Nutritional intervention in overweight middle aged individuals with subjective memory     complaints.   "
40779|NCT02751853|"     Aim of the study is to assess the effects of abruptly increased afterload on left ventricular     contractility and relaxation in patients with heart failure with preserved ejection fraction     (HFPEF), patients with heart failure with reduced ejection fraction (HFREF), and patients     without HFPEF or HFREF.   "
40841|NCT02751034|"     The purpose of this study is to compare the efficacy and safety of the study medical device,     Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction     of nasolabial folds   "
40780|NCT02751840|"     Background. The prevalence of obesity has increased in the last two decades. To maintain body     weight energy expenditure (EE) should be equal to energy intake (EI). A low EE predisposes     individuals to weight gain and to obesity that can also results from low resting metabolic     rate (RMR). Caffeine (Caf) is an active food ingredient and is widely consumed globally, and     has an important impact on energy balance. Caf reduces appetite (EI) and increases EE, thus,     Caf has a potential role in body weight reduction. Caf causes higher total daily energy     expenditure (TDEE) in normal weight (NW) people compared to obese (OW). Moreover Caf is     linked to decreased fat oxidation in OW. There are differences between OW and NW in Caf     pharmacokinetics, but no differences reported between NW and OW females in its effects on     RMR. There is a gender difference in the influence of Caf on metabolism. The investigators     are aware of no previous studies which compared the effect of Caf on the RMR of NW and OW     men.      Objectives. 1) To compare the effect of Caf and coffee on resting metabolic rate (RMR) values     in healthy normal-weight (NW) men and overweight (OW) men. 2) To develop Caf intake frequency     questionnaire (in Hebrew)      Hypothesis. RMR values will be higher and respiratory exchange ratio (RER) values will be     lower in NW compared to the values measured in OW men.      Methods. 33 men (16 NW and 17 OW) were reported to the laboratory on 4 separate occasions     (placebo, Caf tablets, coffee and decaffeinated coffee). During the lab sessions they were     undergo complete anthropometric measurements and RMR measured (one of the study conditions)     using indirect calorimetry. Additionally, respiratory exchange ratio (RER) which is     calculated as the ratio between CO2 production (VCO2) and O2 consumption (VO2) (VCO2/VO2),     blood pressure and heart rate (HR) response recorded.      The importance of this study is that the results will contribute to the scientific basis of     weight control and health interventions programs (diet and physical activity) in overweight     men.   "
40781|NCT02751827|"     In order to assess the important issue of the safety of antiangiogenic TKI in geriatric     population we set up this project which aims to identify, among clinical, biological,     pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI     (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 75 year-old.   "
40783|NCT02751801|"     Hypophosphatasia (HPP) is a genetic disorder caused by mutation in the tissue-non-specific     alkaline phosphatase gene (TNSALP). It causes impaired bone mineralisation, fractures, tooth     loss, muscle weakness and possibly other adverse health outcomes.      The infantile-onset forms are severe, and were often fatal until the recent availability of a     treatment (Asfotase Alfa). The childhood-onset forms are less severe, and the adult-onset     form is mild, and often unrecognised or misdiagnosed as osteoporosis.      The less severe forms of the disease are not well described, and because there has been no     available treatment there has not been much research in adults. However, now that treatment     is available there is a possibility of a clinical trial in adults. To know whether there is a     need for a trial there is a need to determine if there is a significant personal and economic     burden associated with the less severe forms of HPP.      The study consists of a clinical interview and notes review of adults and children with     confirmed (by biochemical and genetic testing) HPP attending metabolic bone clinics in     Sheffield to establish their clinical problems and healthcare use. There are currently about     26 adults and 8 children attending clinics in Sheffield.      The information will be used to plan a data search and health economic analysis of the burden     of HPP from the UK Clinical Practice Research Database in collaboration with Pharmatelligence     (a healthcare data group based within the University of Cardiff).   "
40784|NCT02751788|"     The goal of this project is to examine the physical activity and screen-time environment of     licensed childcare centers before and after the enactment of new state regulations.   "
40785|NCT02751775|"     The objective is to establish community priorities for strategies to improve young children's     health behaviors based on focus groups of stakeholders in the greater Baton Rouge area.   "
40786|NCT02751762|"     The purpose of this study is to quantify the serious risks of misuse, abuse, and addiction     associated with long-term use of opioid analgesics for management of chronic pain, among     patients prescribed ER/LA opioid products.   "
40787|NCT02751749|"     The study uses a replicated randomized single case design. Participants were 12 individuals     with chronic pain problems and residual problems after undergoing a multimodal pain     rehabilitation. They also had comorbid emotional problems. Treatment consisted of 10 weeks of     Internet delivered, therapist guided CBT based self-help treatment based on the Unified     Protocol.   "
40788|NCT02751736|"     The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy     repair operation in patient with rectal cancer improve a bowel function.   "
40789|NCT02751723|"     The aim of this non-investigational study is to determine the symptoms and disease burden at     the time point of diagnosis and in the further course of an incurable cancer disease. The     needs and preferences of patients suffering from cancer (ovarian carcinoma, breast cancer,     malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer,     cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) are examined by     various validated questionnaires. The data obtained by these questionnaires are collected     together with information obtained by the treating physicians at four time points during the     study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor     therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after     patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative     project offers the chance to identify medical services deficits and risk circumstances for     the burden of treatments in an oncology-palliative setting and to optimize the quality of     patient care.   "
40790|NCT02751710|"     This trial is being conducted to determine the impact of whole body FDG PET-CT vs.     conventional staging in the management of patients presenting with clinical Stage III breast     cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be     randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients     with lobular only histology will be entered into a separate single arm prospective study and     will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen & pelvis and a bone     scan.   "
40791|NCT02751684|"     The investigators want to identify and show differences in standards and procedures of     in-hospital rapid sequence induction by collecting data with an online survey for     anaesthetist in Europe.   "
40859|NCT02750800|"     This study aims at evaluate the effect of adalimumab with patient support program (PSP) on     clinical, health economic, patient reported outcomes in patients with rheumatoid arthritis,     ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease and ulcerative     colitis in the routine clinical setting in Hungary.   "
40792|NCT02751671|"     Background:      The investigators recently evaluated a new bladder stimulation technique to obtain     clean-catch urine in infants aged less than six months. In this study, the reported success     rate was of 52%. Measuring the transversal bladder diameter prior to the procedure with     emergency point-of-care ultrasound (ePOCUS) could likely increase success rates for this     technique as it has been described for bladder scans prior to performing urethral     catheterization.      Objective:      The aim of this study is to evaluate if using emergency point-of-care ultrasound to measure     bladder volume improves clean-catch urine collection success in patients less than 6 months     of age when compared to children undergoing this technique without a prior ultrasound.      Methods:      This will be a randomized controlled trial performed in a tertiary paediatric emergency     department. Participants will include all infants younger than 6 months of age who need a     urinary culture and/or analysis requested by the attending physician. The intervention will     consist of the use of emergency point-of-care ultrasound by a trained research assistant. The     primary outcome will be the rate of success of the procedure. Secondary objectives will be to     evaluate time to collect urine samples and to determine which transversal bladder diameter     correlates with more than a 90% success rate for the procedure. Independent variables will be     sex and age. In both groups, trained research nurses will collect clean-catch urine samples     using bladder stimulation techniques. The success rate of the CCU procedure in both groups     will be calculated. The time required to collect urine samples will be analysed. In group 1,     the investigators will determine the transversal bladder diameter corresponding to a success     rate for the procedure of > 80%. It is estimated that, in the worse-case scenario, the     evaluation of 200 participants will provide a 95% confidence interval smaller than 10% for     proportions. In addition, 20 participants with a successful CCU sample would allow to     evaluate 2 risk factors using univariate and multivariate analysis.      Expected results:      This study will demonstrate that use of emergency point-of-care ultrasound increases success     rates of stimulated clean-catch manoeuvres and may avoid invasive urethral catheterizations     in young children.   "
40793|NCT02751658|"     The bacteria live in community and in some cases it is the combination of several     microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome     follows from this finding. Investigators hypothesize that the microbial community water point     is a pathobiome influencing installation and transmission of pathogens associated with care   "
40875|NCT02750592|"     Assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections     up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal     anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy     and safety data will be used to support the registration of secukinumab in Japan for the     treatment of active AS.   "
40796|NCT02751619|"     Thoracotomy is one of the most painful surgical incision. Uncontrolled acute post-thoracotomy     pain reducing deep breathing exercises and secretion clearance increased the incidence of     postoperative pulmonary complications including atelectasis, hypoxemia, and postoperative     pulmonary infections. Thus, an effective analgesia is crucial in order to reduce     perioperative morbidity and hospitalization time and also to prevent chronic post-thoracotomy     pain.      Thoracic epidural analgesia and thoracic paravertebral analgesia are currently the standard     strategies for thoracic surgery but the difficult of performing them in all patients and     their potential complications are all factors that limit their use. Systemic administration     of opioids is the simplest and common strategy to provide analgesia but it may be associated     with several undesirable effects, such as respiratory depression, sedation, nausea,     constipation and vomiting.      In the recent years, preventive analgesia is become one of the most promising strategy of     postoperative pain control. It is based on the concept of administering analgesic drugs     before the occurrence of nociceptive input in order to prevent central sensitization. The     efficacy of preemptive analgesia is unclear and there is no a consensus on its efficacy on     controlling pain after thoracic procedure.      Pain following thoracotomy has a multifactorial genesis including surgical incision,     intercostal nerve injury, pleural inflammation, and damage of pulmonary parenchyma and of     diaphragm. Thus, a multimodal analgesia that intercepts the signalizing at numerous locations     could be more effective than a single strategy targeting one site along the pain pathway.      Thus, in the present study, the clinical hypothesis was that the preemptive analgesia of the     skin using a new tool as the Lidocaine patch 5% would improve the analgesic effects of     systemic morphine analgesia for controlling post-operative pain following thoracotomy.   "
40797|NCT02751606|"     This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in     combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.   "
40798|NCT02751593|"     The project was undertaking by Peking University People's Hospital and other well-known     hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of     ITP in pregnancy.   "
40799|NCT02751580|"     This pilot clinical trial studies how well telehealth works in patients during post radiation     therapy visits. A telehealth virtual office visit can be performed from the patient's home or     workplace, decreasing time spent traveling to visit site, time spent in waiting room, and     cost to patient. Studying telehealth may improve quality of life in patients during post     radiation therapy visit.   "
40800|NCT02751567|"     To evaluate the potential of a test material to produce a photoallergic response.   "
40801|NCT02751554|"     The purpose of this study is to help develop a special PET/CT scan to help the investigator     to develop a new drug and see where this drug goes in the body and how long it stays in     diseased and normal tissue. The drug is called PU-AD. In this study, the investigators will     give a tiny dose of PU-AD, a dose which they expect to be much too small to affect the     disease. This tiny dose will be labeled with (attached to) a very small amount of radiation     (called Iodine-124 or 124I) so that the investigators can follow where it goes in the body by     using a PET/CT scanner. Doing this will help the investigators figure out how to best give     higher doses of PU-AD to other patients in the future, and will help the investigators see if     this tiny dose of PU-AD with radiation (124I-PU-AD) might be used in the future to detect     disease using a PET/CT scanner.   "
40802|NCT02751541|"     To determine the phototoxic potential of a topically applied article in human subjects.   "
40803|NCT02751528|"     The purpose of this study is to determine whether ETBX-021 is safe and effective in the     treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.   "
40804|NCT02751515|"     To evaluate the potential of a test material to produce a photoallergic response.   "
40805|NCT02751502|"     Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be     randomized to receive either a bimanual-to-unimanual device home training program (10     subjects) or a conventional non-device home training program (10 subjects) for a period of 6     weeks.      The specific aims of this proposal are to:      Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI     (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized     that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater     compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home     training program.      Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in     the pediatric population with hemiplegia following ABI.      It is hypothesized that individuals receiving device-based bimanual-to-unimanual training     will show improvement in active range of motion across upper limb joints compared with a     conventional home training program.   "
40807|NCT02751476|"     This study builds evidence on the importance of using safe drinking water during the     nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following     hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will reduce     exposure to pathogens that cause diarrhoeal disease, thereby reducing diarrhoea incidence     among enrolled children. 2.Reductions in pathogen exposure and diarrhoeal disease will result     in shorter recovery pe-riods for children with SAM. The study will evaluate the effectiveness     of safe drinking water in reducing SAM treatment cost and duration and will provide     recommendations for improving SAM treatment protocols.   "
40808|NCT02751463|"     To evaluate the potential of a test material to produce a photoallergic response.   "
40809|NCT02751450|"     This single centre, comparative design study will be used to investigate the efficacy of an     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity     (DH) after short term use compared with a standard fluoride dentifrice.   "
40810|NCT02751437|"     The investigators will explore the effect of current intravenous feeding (parenteral     nutrition (PN)) formulations on blood arginine levels and the genes that are involved in body     nutrition and fighting infection in premature babies. They will also investigate the effect     of supplementing arginine on these genes. The investigators will undertake a single centre     exploratory physiological study in 12 very premature infants receiving PN. 4 of these infants     will be supplemented with arginine. The investigators will record nutritional intake and     routine biochemical testing data (which includes amino acid levels) collected over the first     10 days of life. They will take blood for analysis at prespecified intervals for microarray,     ammonia and IGF-1 levels. Microarray findings will allow the investigators to describe the     effect of arginine on gene activity in preterm infants.   "
40830|NCT02751177|"     RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor     receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is     assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF     genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique     with those achieved using the standard genotyping techniques and formalin-fixed paraffin     embedded samples.   "
40811|NCT02751424|"     A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled,     dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic     (PK) profile of GSK3342830 after administration of single intravenous (IV) infusion in Part 1     and repeat IV infusion in Part 2 in healthy subjects. Part 1 will investigate escalating     single IV doses of GSK3342830. Part 2, will investigate escalating repeat IV doses of     GSK3342830 with repeat dosing for 15 days as follows: a single IV infusion on Day 1, TID     (three times a day) IV infusions on Days 2 through 14 (approximately every 8 hours), and a     single IV infusion on Day 15. The planned starting GSK3342830 dose in Part 1 is 250 milligram     (mg) administered as a single IV infusion. The dose is planned to increase in subsequent     cohorts to 500, 1000, 2000, 4000, and less than or equal to (≤) 6000 mg. Part 1 will be     divided into 6 cohorts (A-F) and each cohort will enroll 10 subjects (6 in active and 2 in     placebo). Dose escalation will be conducted only if it is supported by the preliminary     safety, tolerability, and PK results from the preceding dose levels in the study. The repeat     dose escalation component (Part 2) of this study will be planned to be initiated after     completion and evaluation of the all single dose cohorts up to and including 4000 mg.   "
40812|NCT02751411|"     The study is aimed at the efficacy and safety evalutation of the study treatments through a     2-weeks study period and the subsequent follow-up-   "
40813|NCT02751398|"     This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2     DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the     impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic     dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint     is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on     functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients at     resting diastolic function. This is single-center, randomized, double-blind,     placebo-controlled, parallel-arm intervention study.      This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction     assessed. The dose of dapagliflozin will be 10 mg as approved.      For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was     performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal     exercise capacity were assessed before and after treatment. This study will be randomized,     double blind, placebo controlled, to minimize the risk of bias.   "
40814|NCT02751385|"     Investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a     combination of ethinylestradiol and levonorgestrel (Microgynon®)   "
40815|NCT02751372|"     To determine the phototoxic potential of a topically applied article in human subjects.   "
40816|NCT02751359|"     The purpose of this double-blind, placebo-controlled study is to determine the analgesic     effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have     intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor     Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of     analgesics.   "
40817|NCT02751346|"     This single-center, cross-sectional survey and sensory examination is conducted to determine     the prevalence, sensory characteristics and risk factors of PPSP in patients who underwent     cystectomy at Washington University/Barnes-Jewish Hospital between 2009 and 2015. Based on     data from other lower abdominal surgeries, the investigators hypothesize that 10-15% of     patients undergoing cystectomy will develop PPSP.   "
40818|NCT02751333|"     Esophageal stents are commonly used for benign esophageal pathology, especially strictures or     esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting     factor to stent placement is the high migration rate of the stent. Investigators are trying     to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign     esophageal disease in comparison with standard, fully covered self-expanding metal stents     (FCSEMS) placement without fixation.   "
40857|NCT02750826|"     This randomized phase III trial studies whether weight loss in overweight and obese women may     prevent breast cancer from coming back (recurrence). Previous studies have found that women     who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk     of their breast cancer recurring, as compared to women who were thinner when their cancer was     diagnosed. This study aims to test whether overweight or obese women who take part in a     weight loss program after being diagnosed with breast cancer have a lower rate of cancer     recurrence as compared to women who do not take part in the weight loss program. This study     will help to show whether weight loss programs should be a part of breast cancer treatment.   "
40819|NCT02751320|"     This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period     crossover, incomplete block design, in situ caries study in healthy adults who wear a     removable bilateral mandibular partial denture. The denture will be modified to accommodate 4     gauze-covered specimens of human dental enamel (4x3mm) that have been previously     demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type     will be used with each participant). After 14 days of twice daily product use off-site, the 2     S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion     specimens removed at the study site after a further 14 days of product use. To determine the     remineralization ability of the treatments, all specimens will be analyzed by transverse     microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally     analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by     quantitative light fluorescence (QLF).   "
40820|NCT02751307|"     Metformin has been used for alleviating metabolic abnormalities in patients with     schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in     clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a     lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles in     clozapine-treated patients with pre-existing metabolic abnormalities.      Methods:      In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or     1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia having     pre-existing metabolic abnormalities. The recruited patients underwent physical and     laboratory evaluations at week-4, week-8, and week-12.   "
40831|NCT02751164|"     A retrospective analysis of the Case Mix Programme database to evaluate the association     between day and time of admission to critical care and acute hospital outcome for unplanned     admissions to adult, general critical care units in England, Wales and Northern Ireland.   "
40821|NCT02751294|"     This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution     profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets     exhibiting different dissolution profiles in healthy subjects. This is a single-centre,     2-arm, randomized open-label, parallel-group study in healthy subjects. All subjects will     arrive in the unit approximately 24 hours prior to dosing and will be discharged after the     72-hour post-dose assessments are completed. Subjects will return for outpatient visits on     Days 7, 14, 21, 28, and 56 after dosing. A total of 14 subjects (n=7 subjects in each arm)     are planned to be enrolled. All subjects will receive a single dose of study medication     (2x150 mg TQ tablets + 30 mg TQ SIL in solution) and participate through a 56-day post dose     follow-up visit. To enable the application of peripheral microsampling in planned paediatric     studies, a comparison of the measured pharmacokinetic (PK) exposure via peripheral blood     collection (via microsampling) to venous collection will also be performed in this study.   "
40822|NCT02751281|"     The purpose of this study is to determine which type of percutaneous nephrolithotomy is     better in large kidney stones   "
40823|NCT02751268|"     The purpose of this study is to determine whether bilateral infraorbital and infratrochlear     nerve block in patients undergoing septorhinoplasty are effective in preventing emergence     agitation.   "
40824|NCT02751255|"     Multiple myeloma (MM) patients who develop bortezomib and lenalidomide-resistant disease have     a very poor survival of only a median of 9 months, indicating that new agents are urgently     needed. Recent studies have shown that daratumumab as a single agent is effective and well     tolerated in these heavily pretreated MM patients. However, approximately 60% of patients do     not achieve a partial response, and ultimately all patients will develop progressive disease     during daratumumab therapy.      The investigators have demonstrated that levels of the target antigen CD38, and expression     levels of the complement inhibitory proteins CD55 and CD59 determine the susceptibility of     the MM cells towards daratumumab. In addition, MM cells have lower CD38 expression levels and     higher levels of CD55/CD59 at the time of progression. Importantly, all-trans retinoic acid     (ATRA) upregulates CD38 levels and downregulates CD55/CD59 levels on MM cells, both in     daratumumab naïve cells and in cells that are resistant to daratumumab because of previous     exposure to this drug. These alterations in expression explain the strong synergy between     ATRA and daratumumab, both in MM cells derived from daratumumab naïve patients and from     patients with daratumumab-refractory disease.      These data form the preclinical rationale for clinical evaluation of ATRA and daratumumab in     MM patients.   "
40825|NCT02751242|"     The study team hypothesizes patients at risk for diuretic resistance can be identified early     in their Emergency Department (ED) or hospital stay by evaluating their urine sodium and     potassium concentration after an initial dose of IV loop diuretic. The goal of this pilot     study is to prospectively study urinary electrolyte excretion and determine patterns of     diuretic responsiveness. This study would be utilized to power an interventional study which     aims to study alternative methods of treating patients who are identified as having a poor     response to diuretics in the ED and hospital. This would be expected to have a significant     impact on a patient's hospital course, length of stay and adverse events.   "
40826|NCT02751229|"     The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest     Open Proud' among adolescents with mental illness.   "
40827|NCT02751216|"     This study is an interventional, observatory single center trial investigating the functional     connectivity of the electrical brain activity in high frequency/high density spinal cord     stimulation in failed back surgery syndrome patients with back and leg pain.   "
40842|NCT02751021|"     Little is known about potential relationships between sleep apnea, plasma aldosterone and     diastolic dysfunction which is a very frequent finding among patients requiring permanent     cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation     tests are expensive and access is limited. A specific algorithm available in a recent     pacemaker allows assessing breathing variations using minute ventilation sensor, with a good     agreement between the respiratory disturbance index and polysomnography results for the     diagnosis of severe sleep apnea.      The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm     for the diagnosis of obstructive sleep apnea in patients presenting with diastolic     dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone     levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this     specific population.   "
40858|NCT02750813|"     The purpose of this study is to compare the lens fit characteristics, specifically lens     centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact     lenses.   "
40828|NCT02751203|"     Unintentional injury is the leading cause of death for young children in the United States     (U.S.) and is responsible for more child deaths than they next three causes combined, that     is, homicide, suicide, and cancer. Each year approximately 9,000 children die, 250,000 are     hospitalized and more than 9,000,000 children are treated in emergency departments for     preventable injuries. Child and adolescent unintentional injury deaths have not declined to     the same extent that other diseases have, and resources directed at reducing child injury are     not commensurate with the burden it poses. More than 50% of these injuries occur in and     around the home, where young children spend most of their time.      Unlike diseases such as cancer, there is no need to wait on a cure...there already is one.     Many of these injuries can be prevented through the use of safety equipment and by following     safety recommendations. Using known, effective countermeasures can prevent or reduce the     consequences of a child being injured yet these devices are not routinely utilized. Barriers     related to identifying hazards, finding credible information and recommendations, and     obtaining the safety products best-suited to the features of your home make creating a safe     home challenging for caregivers. Interventions for increasing home safety behaviors have     ranged from educational materials, health care provider counseling, safety product     distribution, hands-on experiential learning in a safety resource center--these have all been     evaluated with varying degrees of effectiveness, however, wide-reaching interventions to     reach large/substantial caregiver audiences, are needed. Offering tailored safety information     on multiple topics via a single platform, combined with the ability to acquire safety     devices, is a more efficient means to reach a large segment of the population and may help     reduce the aforementioned barriers.      Thus, there is an urgent need for mobile technologies to reduce barriers by helping parents     identify injury hazards in their homes, consolidate credible injury prevention     recommendations, organize information by room or feature, tailor by child age, facilitate the     acquisition and installation of safety products, encourage and track progress, thereby     increasing the likelihood that parents accomplish these important life-saving safety tasks.   "
40829|NCT02751190|"     In the present study the investigators aimed to investigate the relationship between surgical     methods and chronic pain in over 20 000 patients who underwent groin hernia repair in Sweden   "
40832|NCT02751151|"     The study will draw patients from the Transplant Dermatology specialty clinic, where the     investigators see organ transplant recipients (OTR) for regular screening and serve as a     regional referral center for this population. Enrollment will be limited to 20 patients.     Inclusion criteria are organ transplant recipients status, active immunosuppression for at     least 5 years, and history of at least one NMSC.   "
40833|NCT02751138|"     Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite     intensive research efforts and a multimodal management that actually consists of surgery,     radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the     current observational study is to determine immune phenotypes in individual patients with GBM     at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties     (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT),     epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as     progression free and overall survival, Karnofsky index (progression free survival     (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes,     biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages,     myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could     predict a positive response to specific immunological therapeutic strategies and select the     individual therapeutic plan for an individual GBM patient.   "
40834|NCT02751125|"     This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges using     biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an implant     into the new bone in a prosthetically guided position.   "
40835|NCT02751112|"     This study is a proof of concept that will assess the Predictor's kit performances. The test     will be performed by several technicians, in immunological laboratories of several sites in     France.      In this study, couples of donor / recipient in the frame of a graft of CSH will be     included.   "
40836|NCT02751099|"     Bone disorder is a significant problem in chronic kidney disease (CKD), becoming almost     universal in stage 5 CKD patients. Besides the healthcare costs, bone disorder is associated     with life-threatening complications, including fractures and cardiovascular (CV) events.     Kidney transplantation provides circa 68% decrease in mortality and improves co-morbidity.     Still, bone disease persists after transplantation.      The investigators hypothesize that bone-derived hormones can induce CV events in kidney     transplanted patients. Therefore, early evaluation of the bone health is recommended, and     prevention of its complications is required. Bone biopsy, an invasive and expensive method,     is the gold standard for bone disorders diagnosis. Therefore, non-invasive predictors for     bone disease are necessary. Classical biochemical markers of bone formation and resorption     have shown a low sensitivity and low specificity. New markers, as fibroblast growth factor 23     (FGF23), and its cofactor klotho, and sclerostin are promising new markers for predicting     CKD-associated bone and CV disease after transplantation.      This study assesses the phenotype of bone disease after transplantation (given by bone     histology) and its correlation with serum FGF23, klotho and sclerostin, in order to evaluate     its performance predicting CKD-associated bone and CV disease.   "
40837|NCT02751086|"     The overall purpose is to develop and maintain a multi-institutional database comprising of     information regarding surgical, clinical and oncological features of patients that will be     treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent     follow-up.      The main objective is to compare the three surgical arms on surgical and clinical outcomes,     as well as on the oncological follow-up.   "
40838|NCT02751073|"     The purpose of this study is to learn more about the microbes (bacteria) that live in the     vagina and the bladder. The investigators are doing this research study to understand the     relationship between microbes (the microbiome) and the occurrence of urinary tract infection     following surgical removal of the uterus and pelvic organ prolapse repair. The investigators     expect Lactobacillus and Gardnerella will be the dominant organisms for most women.     Non-Lactobacillus dominant microbiome communities will be more common in women who ultimately     develop postoperative urinary tract infection.   "
40843|NCT02751008|"     Low bone mass and osteoporosis are underdiagnosed in childhood in our environment and its     prevalence is unknown. In most cases they are secondary to chronic diseases that conduct to a     poor bone health condition and thereby a risk of fracture increased. The aim of this study is     to identify patients with risk factors for low bone mass and determine their Bone Mineral     Density (amount of bone) by performing bone densitometry and compared with healthy population     of the same characteristics. Also the investigators want to evaluate bone quality by     application of Trabecular Bone Score to images obtained by densitometry. As secondary     objectives the investigators intend to correlate the data with with clinical variables to     identify the most important in bone health clinical factors. In addition to measuring bone     quality and quantity demographic and clinical process related to bone quality base and     variables will be collected.   "
40845|NCT02750982|"     This is a prospective investigation of the effects of Laughter therapy (LT) on perceived     stress, self-efficacy, mood and other wellness measures in people with the following     neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury,     Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord     injury.   "
40846|NCT02750969|"     The investigators like to learn whether Lidoderm patch (lidocaine 5%) helps tinnitus     patients.      so far it is known that lidocaine I.V do helps tinnitus but until now it is not clear if     other means of drug delivery (e.g lidocaine patch) help tinnitus.      The investigators are going to compare 1 day of treatment with lidoderm patch cream Versus     (VS.) tegaderm patch (containing no drug) in treating tinnitus patients.   "
40847|NCT02750956|"     The primer aim of the study was to determine serum and gingival crevicular fluid (GCF)     endocan levels in periodontal diseases pathogenesis supported with vascular endothelial     growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.   "
40848|NCT02750943|"     This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and     baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in     healthy adult volunteers with moderate gingivitis. This study will evaluate the efficacy of a     dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control gingivitis     and gingival bleeding following 12 weeks twice daily brushing, compared to a negative control     dentifrice.   "
40849|NCT02750930|"     Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an     adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and     has been approved by the United States (US) Food and Drug Administration (FDA), the European     Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single     group, multicenter, extension study to Study 200952. This extension study will provide     extended safety, tolerability and immunogenicity data for the albiglutide liquid drug     product. This extension study will comprise 2 study periods: treatment (26 weeks) and     post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part     in this extension study.   "
40850|NCT02750917|"     The purpose of this study is to assess efficacy and safety of lornoxicam compared with that     of etoricoxib after total knee replacement.   "
40851|NCT02750904|"     This purpose of the study is to develop and test a new website to help people who have     bipolar disorder quit smoking.   "
40852|NCT02750891|"     This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent     and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.   "
40853|NCT02750878|"     The purpose of this study is to determine if addition of a handout to the standard consent     process for the trans-obturator tape (TOT) mid-urethral sling procedure will improve     patients' understanding, recall and satisfaction with their procedure. The information     provided in the handout will include the procedure details, the accompanying risks and     benefits, as well as the expectations and alternatives to the TOT procedure. The aim of the     investigators is to improve and standardize the current process for surgical consent for     patients undergoing a mid-urethral sling procedure, specifically the TOT. The investigators     hypothesize that addition of a handout will improve patient's preoperative comprehension by     an absolute value of 10% compared to the standard consent process. The investigators further     hypothesize that the handout will improve patient satisfaction and recall of the surgical     procedure details post operatively.   "
40854|NCT02750865|"     In this study the investigators will advance research on the development of easy to use     technologies to empower patients. This is a scalable approach that has a significant     potential to reduce suffering for palliative care patients and their caregivers. The     investigators will adapt existing tested empathic conversational agents (ECA) for home-based     cancer care management and inpatient bedside counseling to provide the following functions:        1. medication counseling;        2. physical activity promotion;        3. symptom management and continual screening for adverse events; and        4. alleviation of stress and anxiety        5. spiritual needs assessment; and        6. advanced care planning.      Data from the system will be monitored by a health professional, who communicates with     members of the patient's care team. In this project, this activity will include facilitating     referral for palliative care services.      The investigators will conduct pilot studies both at Boston Medical Center and at     Northeastern University that will test system usability (Northeastern University and BMC) as     well as interview burden (BMC only).      The investigators will conduct a Randomized Control Trial (RCT) to evaluate the agent     technology, comparing usual care (UC) versus usual care plus the agent (UC+ECA) for patients     21 or older, with a life expectancy of < 1 year, from outpatient clinics at Boston Medical     Center (BMC). Each subject will be enrolled along with a caregiver surrogate subject. In     addition to baseline data collection, there will be monthly phone surveys for six months;     intervention subjects will use the system for a six-month period of time. In addition, the     investigators will conduct a randomized trial within the intervention group to compare     subjects getting functions 1-4 (above) versus subjects getting the augmented intervention     with all six functions. The intervention will include a nurse management interface to monitor     clinical alerts generated by the system to stimulate interventions by the clinical staff.   "
40855|NCT02750852|"     Aim of these study is to create an algorithm, using data from patients that undergoing total     hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.   "
40856|NCT02750839|"     Aim of the study is to analyze results of treatment of proximal humerus fractures with     mini-invasive technique and plate fixation.      In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray     results will be statistically analyzed to evidence any connection between clinical outcomes     and osteoporosis.   "
40861|NCT02750774|"     High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are     associated with many unfavourable maternal and neonatal outcomes.      Adherence to lifestyle recommendations could be a major determinant of the efficacy on     preventing unfavorable outcomes, namely among overweight/obese women. Previous studies     investigated adherence to specific dietary patterns and their effect on pregnancy outcomes;     however, no study has investigated adherence among overweight/obese pregnant women and its     effect on the onset of several maternal-neonatal outcomes.      This study aimed to determine whether the prescription of a lifestyle program, consisting of     a customized low-glycemic index (GI) diet and a physical activity program, in overweight and     obese women could affect the occurrence LGA babies. It also aimed to determine whether this     kind of prescription influences the adherence to healthier eating habits, and how this, in     turn, can influence the occurrence LGA.   "
40862|NCT02750761|"     This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active     metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a     single IV (Part A) or oral suspension (Part B) administration to hospitalized participants     ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4,     respectively).   "
40863|NCT02750748|"     To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone     compared to an intramuscular dose of naltrexone.   "
40864|NCT02750735|"     In the last few years, a new clinical entity has emerged which includes patients who consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named     non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators     suggested the term non-celiac wheat sensitivity (NCWS), because it is not known to date     what component of wheat actually causes the symptoms. Nickel is the fourth most used metal     and the most frequent cause of contact allergy in the industrialized world. As a natural     element of the earth's crust small amounts are found in water, soil, and natural foods,     especially plant ones. Nickel allergy not only affects the skin but also results in systemic     manifestations. Systemic nickel allergy syndrome can have cutaneous (urticaria/angioedema,     flares, itching), and/or gastrointestinal (meteorism, colic, diarrhoea) signs and symptoms.     In this study, the investigators evaluated 1) the frequency of Nickel allergy and Systemic     Nickel allergy syndrome in NCWS patients, and 2) the clinical, serological, and histological     characteristics of NCWS patients with contact dermatitis Nickel positive in comparison to     NCWS patients without contact dermatitis.   "
40865|NCT02750722|"     The investigators aim to compare a single bout of moderately intense cycling exercise     incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling     exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the     lungs in adult patients with cystic fibrosis.      The investigators further aim to analyze the short-term variability of resting diffusion     capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.   "
40866|NCT02750709|"     The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1     (TP1)) and Nitisinone 10 mg Tablets High Compritol (Test Product 2 (TP2)) are bioequivalent     to the reference product Orfadin 10 mg capsules.   "
40867|NCT02750696|"     Aim: The aim of this study was to compare the analgesic efficacy of two combinations of     opioid and non-opioid analgesics for acute periradicular abscesses.      Methodology: This study included 24 patients who sought emergency care in a Brazilian dental     school. The patients were randomly divided into two groups: Codeine/Acetaminophen - oral     prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or     Tramadol/Acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus     acetaminophen (500 mg) on the same schedule. Patients recorded pain scores in a pain diary 6,     12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale.   "
40868|NCT02750683|"     Norepinephrine (NE) is a potent vasopressor used in septic shock to reverse hypotension.     Early infusion of NE was associated with a favorable clinical outcome in a large cohort of     patients . When administered early, NE increases cardiac output (CO) in patients with septic     shock . This effect was suggested to be mainly related to an increased cardiac preload via     the α-adrenergic-mediated decrease in systemic venous capacitance . Whether NE exerts a     positive effect on cardiac contractility through β1-adrenergic stimulation is unclear. On the     one hand, the sensitivity of β1-adrenergic receptors can be abnormally reduced in septic     conditions. On the other hand, such a sepsis-induced down-regulation of β1-adrenergic     receptors may occur relatively late and thus, might not be observed when NE is administered     early. Our study was designed to examine the inotropic effects of NE when administered in the     early phase of human septic shock   "
40869|NCT02750670|"     This is a pilot study to determine the overall survival rate and toxicities of obinutuzumab     given with GDP chemotherapy for relapsed or refractory CD20+ aggressive non-Hodgkin lymphoma.     Patients who have CD20+ and progressed R-CHOP therapy will be enrolled into the study. About     30 patients are planned to be enrolled from Princess Margaret Cancer Centre.      If the enrollment is very slow then additional site may be included. Patients will receive     Obinutuzumab +GDP for 3 cycles intravenously. CT scan will be used to evaluate the response     rate after cycle 2 and PET-CT will be used after cycle 3. Responders (complete metabolic     response, partial metabolic response) should proceed to autologous stem cell transplant     (ASCT). Patients who have progressed after three cycles or less are to have their protocol     treatment discontinued, with subsequent treatment at investigator discretion. Patients will     be followed up to 24 months from transplant done or last chemo. Mandatory tissue submission     and optional tissue and blood submission are required for the correlative component of this     study.   "
40870|NCT02750657|"     Researchers are looking for better ways of understanding and treating pancreatic cancer. The     purpose of this study is to see how useful it is to look for changes and characteristics in     your genes (molecules that contain instructions for the development and functioning of the     cells) and the genes within the tumour. These characteristics may be useful in choosing     treatments for patients in the future. Changes (mutations) in genes have been shown to be an     important characteristic in cancers. Looking at differences in genes in patients with     advanced pancreatic ductal adenocarcinomas and comparing this information with response to     their initial chemotherapy treatment may help to learn which treatments may be better for     certain patients after initial treatment.   "
40871|NCT02750644|"     Until the irruption of the Carotid Revascularization Endarterectomy versus Stenting Trial     (CREST), carotid stenting (CAS) has been mainly offered to those patients considered at high     risk for open carotid endarterectomy (CEA) based on the available data from large randomized     clinical trials. High risk has been defined as (1) patients with severe comorbidity (class     III/IV congestive heart failure, class III/IV angina, coronary disease involving ≥ 2 major     vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary     disease, severe renal failure) and (2) Technical/challenging anatomical criteria (previous     neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy     restenosis, inaccessible lesions or tracheotomy). Several recent studies have called medical     high-risk into question for CAS indication.      The purpose of this study is to evaluate the safety and perioperative and long-term     effectiveness in patients with significant carotid artery stenosis with high-risk criteria     (for CEA) treated with carotid stenting and proximal protection device (MOMA®) compared to     patients with standard-surgical-risk features.   "
40872|NCT02750631|"     Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times     ending at their desired sleep time. Beginning the morning following their Wake Night,     patients sit in front of a bright light, continuing morning bright light and specified sleep     time for six weeks with weekly visits measuring depressive symptoms.   "
40873|NCT02750618|"     UX023-CL205 is a multicenter, open-label, Phase 2 study in children from 1 to 4 years old     with XLH to assess the safety, PD, and efficacy of KRN23 administered via subcutaneous (SC)     injections every 2 weeks (Q2W) for a total of 64 weeks.   "
40874|NCT02750605|"     The purpose of this trial is to compare short- medium long-term results in treatment of PAD     (peripheral arterial disease) in the crural arteries with either drug coated balloon or     conventional balloons in a prospective , randomized, single center study      Results will be defined as:      Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization),     Primary patency, Clinical success, Serious adverse events, and the patients will be     followed-up for 1 years.      Primary endpoints:      Primary Patency at 12 months      Secondary endpoints:      Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse     events, TLR (clinical driven),   "
40893|NCT02750358|"     This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an     androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+)     triple negative breast cancer (TNBC).   "
40876|NCT02750579|"     Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and     high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the     rate of cardiovascular death and recurrent myocardial infarction in this clinical setting.     The recommendation regarding the timing of intervention in this clinical setting is derived     from old trials and has a weak level of evidence. In fact, there are no conclusive randomized     trials in the contemporary era providing guidance on the optimal timing of intervention. In     addition, the optimal timing of this critical intervention has not been studied since the     development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of     pretreatment with a P2Y12-ADP receptor antagonist before intervention. Early intervention in     intermediate and high-risk non ST-elevation ACS is not well validated to date. In addition,     the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact     on the potential benefit of an early intervention.      Based on these evidences, we hypothesize that with the current protocols of care without     pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (<2 hours) would be superior     to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST     elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences.   "
40877|NCT02750566|"     Concussion or mild traumatic brain injury (TBI) is a challenging injury for physicians to     manage and is among the most serious disabling neurological disorders. Physician awareness     regarding manifestations of TBI and subsequent treatment are paramount to reduce the burden     of disease. Advancements in treatment of mild TBI have been slow with a lack of consensus on     treatment methods that show universal success. This gap in treatment choices provides an     opportunity for osteopathic manipulative treatment (OMT) to fill. OMT is a hands-on manual     therapy that can be integrated to help treat post-concussive symptoms. Previous studies have     shown that OMT can help resolve imbalance and tinnitus in elderly populations and case     studies have shown that this manual therapy may assist in patient recovery. The investigators     hypothesize that OMT will decrease return to play/work time, will show an improvement in     balance, and will decrease concussion symptoms as compared to counseling.   "
40878|NCT02750553|"     This is a randomized, placebo-controlled, single & multiple dose escalation study to     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The     study will be conducted with starting dose of 5 mg followed by dose escalation groups up to     100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug     or placebo.   "
40879|NCT02750540|"     DREAM-01 is an early phase 1, open label, dose-escalation and variable osmolarity study to     compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3     formulations of a tenofovir (TFV) enema. The goal of the study is to identify the dose and     osmolarity of a TFV enema for human immunodeficiency virus (HIV) pre-exposure prophylaxis     (PrEP) which achieves the desired colonic mucosal mononuclear cells (MMC) tenofovir     diphosphate (TFV-DP) target concentrations that have previously been shown to confer     protection from HIV acquisition in men who have sex with men (MSM).   "
40880|NCT02750527|"     This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6     years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9)     routine check-ups and any voluntary visits to the pediatricians office.   "
40881|NCT02750514|"     The purpose of this study is to determine whether Nivolumab, in combination with other     therapies, is more effective than Nivolumab by itself in patients with advanced Non-Small     Cell lung cancer.   "
40882|NCT02750501|"     Protocol 0000498 is a multi center, open label study to evaluate the safety, tolerability and     fat absorption of sustained Relizorb (immobilized lipase cartridge) use for patients with     cystic fibrosis and exocrine pancreatic insufficiency who receive enteral tube feeding.   "
40885|NCT02750462|"     The aim of the trial is to compare immediate angiography in survivors of out of hospital     cardiac arrest (OHCA) without ST-segment elevation versus delayed/selective catheterization     with respect to 30 day mortality.      The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).   "
40886|NCT02750449|"     To evaluate the potential of a test material to produce a photo allergic response.   "
40887|NCT02750436|"     Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint     pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch     blocks. Outcomes examined will include performance times and success rates.   "
40888|NCT02750423|"     Investigators are seeking to learn how well different cooling temperatures along with     different blood flow pathways to the brain reduce the risk of injury to the brain in     participants planning to undergo elective aortic arch and hemiarch surgery. Participants will     be randomized to receive a cerebral protection strategy of either: deep hypothermic     circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic     circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).     Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests,     MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow     ups.   "
40889|NCT02750410|"     The main purpose of this study is to evaluate the efficacy and safety of combination therapy     with dulaglutide and insulin in Japanese participants with type 2 diabetes.   "
40890|NCT02750397|"     HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from     an HIV+ deceased donor will be followed to determine the safety and efficacy of this     practice. HIV+ individuals who receive a solid organ transplant from HIV-uninfected donors     will also be followed.   "
40891|NCT02750384|"     This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen,     parallel group study in 42 subjects   "
40892|NCT02750371|"     Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It     was observed that durable memory impairments could arise at irradiated patients if     radiotherapy is applied on medial temporal lobes.      However, results concerned studies of anterograde memory and none, this day, estimates the     impact of radiotherapy on autobiographical memory which also involves hippocampus.      The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation     on autobiographical memory.      Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for     who radiotherapy is indicated will be recruited.   "
40899|NCT02750280|"     This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem®     plus standard local wound care versus standard local wound care alone in the treatment of     diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks     and ulcer recurrence with a 2 year follow-up.   "
40900|NCT02750267|"     The overall aim of this proposed research is to determine the safety, feasibility and     efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and     night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple     48 hours in an out-patient setting.   "
40901|NCT02750254|"     Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapy     for patients with hematologic malignancies including acute myeloid leukemia (AML),     myelodysplastic syndrome (MDS), and acute lymphoblastic leukemia (ALL); however, human     leukocyte antigen (HLA)-matched donor availability continues to be a major hurdle.     Historically, HLA haploidentical donor hematopoietic cell transplantation (haplo-HCT) was     associated with high incidences of graft rejection and excessive non-relapse mortality (NRM),     but recent advances utilizing post-transplant cyclophosphamide (PT-Cy) have revolutionized     haplo-HCT and the outcomes are now comparable to allo-HCT using more traditional HLA matched     related and unrelated donors. However, graft-versus-host disease (GvHD) continues to be a     problem and is associated with significant morbidity and mortality in allo-HCT patients     including those who receive haplo-HCT on PT-Cy platform. The aim of this early phase study is     to investigate the safety and overall efficacy of azacitidine in reducing the incidence and     severity of GvHD when added to PT-Cy based haplo-HCT platform for patients with AML, ALL, or     advanced MDS.   "
40914|NCT02750085|"     This is an investigator-initiated, industry-funded, multi-centre, international study that     will be carried out prospectively at hemophilia treatment centres across Canada, the Czech     Republic and Australia with SickKids as the coordinating site. The study will use a central     laboratory not directly affiliated with any of the participating sites. Enrollment target is     50 participants, both adult and pediatric with severe hemophilia A receiving Advate, who will     each complete a 2-point and 6-point pharmacokinetic (PK) sampling. The main aim is to compare     the results of a 2 sample PK using clinically practical time points and myPKFiT™ (a     web-based, population PK Bayesian tool) to a 6 sample population PK to determine whether the     results obtained are in good agreement.   "
40902|NCT02750241|"     Breast cancer survivors, from diagnosis until the end of life, go through many transitions.     One major transition is the significant decrease of physical activity immediately after     diagnosis. Despite the known benefits of physical activity—speeding recovery time and reduced     cancer recurrence risk—only 1 in 3 survivors met physical activity recommendations of 150     minutes of moderate-intensity activity per week. Physical activity interventions have shown     effectiveness in helping breast cancer survivors increase physical activity during treatment,     but limited evidence-based physical activity interventions have been incorporated into the     clinic and community. To address this limitation, the investigators are partnering with the     UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink     Warrior.      The goal of this study is to compare an intervention that uses active games versus an     intervention uses pedometer to encourage physical activity such as walking within breast     cancer survivors in active cancer treatment. The study will include breast cancer survivor     between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical     activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants     will be randomized to participate in the support group using the active video game-based     physical activity intervention (Wii and Xbox active games) or to participate in the existing     UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators     hypothesize that by engaging in active video gaming, breast cancer survivors will be     motivated to initiate and maintain physical activity during treatment. This will ultimately     increase functional capacity and prevent functional disability in breast cancer survivors.   "
40903|NCT02750228|"     The purpose of this study is to track post-discharge outcomes on prematurely born infants who     are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to     report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac     events in these infants. The goal is to identify risk factors associated with adverse     outcomes in prematurely born infants who are sent home with a PDA.   "
40904|NCT02750215|"     This research study is studying capmatinib as a treatment for advanced non-small cell lung     cancer with MET exon 14 skipping, where the participant has already received prior therapy     with a MET inhibitor.   "
40905|NCT02750202|"     Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in     South Africa. Medical and destructive therapy for small warts is generally very effective,     however unique problems posed by large or extensive genital warts are not so easily solved     and treatment of affected patients remains very challenging. Recurrences are common     especially among immune-compromised women. This study will test whether giving the     quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior     to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment     with HPV vaccine can play a role in the control of both malignant and benign HPV disease in     women with and without HIV infection through stimulation of the antibody response. In     addition, HPV types and other associated diseases will be studied in women receiving HPV     vaccine and placebo.   "
40906|NCT02750189|"     The purpose of this study is to estimate a direct/indirect medical cost and to provide     evidence establishing efficient strategies to reduce medical costs of COPD in Korea.   "
40907|NCT02750176|"     A single arm design will be used to assess the feasibility and preliminary efficacy of a     closed-chain rehabilitation protocol for patients with full thickness rotator cuff tears of     the shoulder. Full thickness rotator cuff tears will be documented using MRI or ultrasound     images. 30 participants will be recruited for this study. The rehabilitation protocol will     include two stages: stage 1, physical therapy, and stage 2, gym program. Stage I will include     a total number of session between 12 and 24. The number of session included in stage 2, will     depend on the total number of session completed during stage 1. The total duration of both     stages will 5 months.   "
40908|NCT02750163|"     Aim of this study is to evaluate the effect of paracetamol administration on the     microcirculation, on the plasmatic levels of free hemoglobin and on the oxidative stress of     septic patient with fever.   "
40909|NCT02750150|"     Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is     present in 40% of cases. It has a very early onset and this coagulopathy is associated with     increased mortality. It must be detected and treated early, as illustrated by the military     medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP)     requires a thawing step.The French army has encouraged the development of a freeze-dried     plasma of innovative because viral inactivation and universal blood grouping, well tolerated,     with a reduced risk of TRALI. This sophisticated therapeutic product can be administered     after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used     is currently reserved for military purpose in overseas operations and needs to be evaluated     for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of     an immediate availability of plasma.   "
40910|NCT02750137|"     Ametop was introduced into the formulary as it was deemed more efficacious for intravenous     cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be     higher compared to other studies. This lead to a prospective observational study to look at     the incidence and severity of skin reactions following routine clinical application of     Ametop.   "
40911|NCT02750124|"     The main purpose is to develop and test an IT-infrastructure to provide more individualized     ways of inviting and reaching women who have not participated, despite having been invited     with annual reminders, in cervix cancer screening program during a ten year period.   "
40912|NCT02750111|"     Determine the incidence of hypoglycemia during / after sexual intercourse among young adults     with type 1 diabetes using continuous -type sugar meter IPRO for a week.   "
40913|NCT02750098|"     Comparison of aqueous and plasma glucose level in diabetic patients      High glucose concentrations in aqueous humor are thought to be related of diabetic ocular     injury, including cataract and diabetic keratopathy. The primary mechanisms are nonenzymatic     glycation, oxidative stress and activation of polyol pathway. However, glucose concentrations     in aqueous humor of diabetic patients was only examined in a few patients in the past.      This study will compare glucose concentration in blood plasma and aqueous humor in diabetic     patients undergoing cataract surgery. Perioperative Hemoglobin A1c concentrations will also     be examined. Correlation between these parameters will be analyzed.   "
40915|NCT02750072|"     This study will investigate the incidence and severity of anterior knee pain comparing two     different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended     suprapatellar incisions. Half the patients will be randomized to the gold standard     infrapatellar approach with the other half being randomized to treatment with the     percutaneous semi-extended suprapatellar approach.   "
40916|NCT02750059|"     Primary objective: To compare telmisartan therapy + antiretroviral therapy (ART) versus ART     alone during acute Human Immunodeficiency Virus (HIV)a infection in reducing systemic immune     activation and trafficking of activated and HIV-infected cells to the central nervous system     (CNS), and limiting establishment and persistence of the CNS reservoir of HIV.      At 48 weeks (during the telmisartan therapy) and 72 weeks (~6 months after cessation of     telmisartan augmentation), the investigator expect subjects in the telmisartan group will     have reduced levels of blood and CSF immune activation markers, reduced brain inflammation,     lower CSF HIV ribonecleic acid (RNA) and improved neuropsychological testing performance.      Secondary objective: In subjects who are willing to undergo the optional inguinal lymph node     biopsy, the study will determine whether subjects receiving telmisartan plus ART for 48 weeks     develop less lymphoid tissue fibrosis than subjects receiving ART alone for 48 weeks.      Subject population: Male and female subjects age ≥ 18 years old with acute HIV infection who     are identified and enrolled in SEARCH 010/RV254 protocol will be asked to co-enroll in this     study.      Number of subjects: 21      Duration of follow-up: 72 weeks      Study design: 21 acutely HIV-infected subjects will be randomized 2:1 to treatment with     telmisartan + ART (n=14) vs. ART alone (n=7) for the first 48 weeks followed by ART alone in     both arms to week 72. Blood and CSF, magnetic resonance imaging (MRI), and neuropsychological     testing and exam will be collected at baseline, week 48 and week 72. Inguinal lymph node     biopsy is an optional procedure that will be offered at baseline and week 48.   "
40917|NCT02750046|"     RATIONALE: Collecting and storing bone samples from patients with osteoporotic and     nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon     learn more about the relationship between bone mineral density (BMD) and a special vessel     subtype (type H vessel).      PURPOSE: This research study is looking at changes of a special vessel subtype in bone     samples from patients with osteoporotic and nonosteoporotic fracture.   "
40918|NCT02750033|"     The research team will develop an intraoperative handheld device for assessing surgical     margins during Mohs surgery. The device technology is based on multimodal optical     spectroscopy (MMS), combining three optical spectroscopy techniques into one device. The     researchers will first acquire proof of concept MMS measurements within the Mohs surgery     suite immediately after surgical excision and prior to histological processing. MMS     measurements will be acquired directly on the patient from the NMSC excision site. The final     outcome of this study will result in the sensitivity and specificity of MMS compared to     histopathology during Mohs surgery. These results will allow for the estimation of the     potential benefit of an intraoperative margin assessment technique.   "
40930|NCT02749877|"     Cancer survival comes at a price: pediatric cancer survivors have a high risk for a wide     range of cognitive difficulties, particularly survivors of cancer involving the central     nervous system (CNS, e.g., brain tumors [BT]) are prone to neurocognitive impairments in     areas such as executive functions, working memory, attention, memory, visuospatial and motor     skills, processing speed as well as language. The aim of this interdisciplinary longitudinal     study is to extend empirical knowledge on training and transfer effects in children with a     history of cancer. It is hypothesized that early cognitive and physical interventions affect     the remediation of pediatric cancer survivors in terms of cognitive functions. These changes     are further hypothesized to be associated with white matter changes.   "
40973|NCT02749318|"     This is a pilot study to determine whether knowledge gained by an individual of genetic risk     for severe periodontitis changes the patient's health behavior as measured by an increased     frequency of their preventive dental office visits. In addition to the primary objectives of     the study, the overall design and logistics will be used to inform a possible future study.   "
40919|NCT02750020|"     Current study is the fourth wave of the policy-related survey on tobacco control in Hong     Kong. It aims to investigate the level of public support on current and future tobacco     control measures and taxation policies and to address the timely impacts of smoke-free     policies, substantiate public support on further tobacco control measures and assist COSH in     shaping policy direction for government. In total, 5000 subjects will be randomly selected     for a telephone interview. The subjects will be categorized into three groups, i.e. never     smokers (1667), ex-smokers (1667) and current smokers (1667). They will be required to answer     a questionnaire via telephone. All data shall be collected using a Computer Assisted     Telephone Interview (CATI) system, which allows real-time data capture and consolidation. All     interviews shall be conducted anonymously. Analysis of survey data will aim to identify     current opinion on tobacco control policies and implications for future policies. Analyses     will be controlled for confounding variables as required by stratification into sub-groups     based on important pre-defined characteristics and/or by multivariate analysis. Comparison     with past trends and, where possible, extrapolation of future trends will be explored.     Weights will be applied to adjust for the sex and age of Hong Kong population, and to handle     the over-sampling issues of current smokers. The data analysis will be conducted by     statisticians.   "
40920|NCT02750007|"     This study is conducted in China. The aim of this trial is to assess the tolerability to     HS-20004 with titration administration in type 2 diabetic patients.   "
40921|NCT02749994|"     A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design     clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and     rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.   "
40922|NCT02749981|"     Pharmacokinetics of cefazolin in children undergoing cardiac surgery.   "
40923|NCT02749968|"     This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall     trauma.   "
40924|NCT02749955|"     This study evaluates the feasibility (reach, adoption, safety and implementation) and initial     efficacy (higher linkage to care) of the Partner Services Pre-exposure Prophylaxis (PS-PrEP)     intervention versus phone based Pre-exposure Prophylaxis (PrEP) treatment at 3 months post     randomization among a sample of high risk individuals 18 - 35 years from clinic-based     recruitment and internal referrals from social network based projects. The evaluation of the     intervention will be used to strengthen routine department of public health services linkage     to PrEP care.   "
40935|NCT02749812|"     The investigators propose a multicentric controlled randomized trial whose goal is to     evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous     positive airway pressure) and constant CPAP (constant positive airway pressure) in 800 severe     obstructive sleep apnea syndrome (OSAS) patients according to their profile of pressure     variability.   "
40936|NCT02749799|"     The purpose of this study is to assess patient satisfaction when DFD-01 is used topically     twice a day for moderate plaque psoriasis.   "
40990|NCT02749097|"     This is a randomized, placebo-controlled, single dose escalation study to investigate the     safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be     conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Eight     subjects will be randomized in 3:1 ratio in each cohort to receive the study drug or placebo.   "
40925|NCT02749942|"     Objective The objective of this study is to investigate if long-term ambulatory remote     ischemic conditioning can improve symptoms and signs of peripheral arterial disease in     patients with type 2 diabetes.      Background Peripheral arterial disease (PAD) is a vast socioeconomic challenge in the     community of diabetes patients, causing foot ulcers and lower extremity amputations. The main     treatment option for the complication is operative revascularisation. Thus there is a need     for new treatment modalities for diabetes patients with PAD.      Remote ischemic conditioning (RIC) is at non-invasive non-pharmacological treatment which has     been shown to attenuate tissue damage caused by ischemia e.g. in hearts subjected to     ischemia. RIC treatment consists of brief repetitive periods of ischemia induced in an     extremity e.g. an arm. Recent findings show that six week RIC treatment improves healing of     diabetic foot ulcers, suggesting a possible effect on the underlying pathological causes of     ulcers e.g. PAD.      Hypothesis The investigators hypothesize that RIC treatment can improve markers of     inflammation, vascular and neuronal function and the sense of empowerment in type 2 diabetes     patients with reduced peripheral blood supply.      Aim to conduct a single center double-blinded randomized placebo controlled study     investigating the efficacy of home based 12-week RIC treatment on markers of vascular,     neuronal function, inflammation and serum lipid composition in 40 type 2 diabetes patients     from Steno Diabetes Center with non-critical PAD.      to qualitatively investigate the experience of empowerment related to the use of Remote     Ischemic Conditioning (RIC) treatment and the mechanisms affecting if and how participants     take up the RIC treatment.   "
40926|NCT02749929|"     Approximately 15,000 persons in Norway suffer from a wrist fractures during a year, making it     the most prevalent fracture in this country. Treated conservatively, a cast is used for 4-6     weeks before removal. After discontinuation of the cast, physiotherapy is implemented to aid     in improving range of motion and regaining function of the injured wrist. The pain after     injury can affect the patient to a greater or lesser extent, and it is common to prescribe     sick leave for shorter amounts of time after the injury.      Studies suggest that a physiotherapy intervention with Low Level Laser therapy (LLLT) may     reduce pain and swelling after acute trauma, and potentially promote healing. The aim of this     study is to evaluate the effect of LLLT on pain and function at 2, 4, 8 and 26 weeks after     injury.   "
40927|NCT02749916|"     This study aims to compare image-based characteristics of carotid walls between symptomatic     side and the opposite side. The design of this study is phase IV, prospective observational     study.   "
40928|NCT02749903|"     This study will test any good and bad effects of the study drug called enzalutamide.     Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope     to learn if the study drug will shrink the cancer by at least 30% compared to its present     size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary     gland cancer, but it has already been FDA-approved to treat other cancers.   "
40931|NCT02749864|"     The hypothesis of this investigation stresses that the current understanding of the     prevalence of HCV infection in the general population and in different subgroups will serve     to lay out medium- and long-term measures for action geared toward reducing the disease     burden through preventive, research, screening and therapeutic measures.      Aim: To determine the prevalence of seropositivity and chronic infection with the HCV and to     analyze the associated factors. To analyze and infer different screening strategies for HCV     infection based on the at-risk groups/cohorts of elevated prevalence detected.   "
40932|NCT02749851|"     The purpose of this study is to test the application of newly generated magnetic resonance     imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The     primary objective is to validate and establish the utility of placental MRI in pregnant     women. The study will be entirely MRI-technology based with collection of placental tissue at     the time of infant delivery for later correlative studies.   "
40933|NCT02749838|"     Purpose of the Protocol:        -  To prospectively identify cancer patients whose tumors express specific molecular          markers targeted by therapeutic agents, for the purpose of selecting the most clinically          appropriate anticancer therapy, including clinical trial opportunities.        -  To collect and analyze biospecimens from cancer patients, using primarily standard of          care laboratory methods, for the purpose of determining the expression of specific          genotypic and phenotypic disease markers of scientific and medical interest.        -  To create a protocol database, including case and disease stage-matched clinical and          therapeutic history data in addition to patient biomarker profiles, to serve as:             -  a systematic collection of data for comparing patient data to clinical trial               selection criteria for the purpose of informing a clinical investigative site of               available clinical trials matching patient clinical status;             -  a collection of clinically matched, comprehensive molecular results for scientific               and research and development applications.   "
40934|NCT02749825|"     This research study looks at Testosterone levels in patients receiving Trelstar versus those     receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer     by the FDA.   "
41053|NCT02748278|"     IVF is a well-established method to treat various causes of infertility. Some studies have     suggested that ethnicity affects the success of IVF. This is a prospective study involving     two tertiary IVF units in Hong Kong and Australia. The IVF outcome between Chinese and     Caucasians will be compared.   "
40937|NCT02749786|"     Rosacea is a common disease characterized by inflammation and vascular abnormalities of the     facial skin and ocular surface. It it considered to be a syndrome encompassing various     combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema,     ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is     characterized by persistent vasodilation, increased vascular permeability, and vascular     hyper-reactivity of the microcirculation of the central part of the face. The purpose of this     study is to develop gene expression profiles of papulopustular rosacea compared to those of     normal skin. The investigator hopes to better understand the abnormal gene functions that     might contribute to this condition. This understanding may lead to the development of     additional and better treatments for rosacea.   "
40938|NCT02749773|"     The aim of this study is to determine whether different needle gauges influences the quality     of the aspirated oocytes during in-vivo fertilization (IVF).   "
40939|NCT02749760|"     This is a study of the muscle stabilizers of the elbow with respect to the prevention of     Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring     training and end of season for approximately 5 years. Pronator, flexor digitoum superficialis     (FDS), and wrist flexion strength will be measured and correlated with upper extremity     injuries and time missed from pitching. The investigators will also be measuring loss of     strength over the season. The goal is to learn whether strength in these muscles prevents UCL     injuries and finally whether these muscles can be strengthened to avoid such injuries.   "
40940|NCT02749747|"     -  Introduction: Estrogen hormonal therapy associated or not with progestagen is the          standard therapy for the treatment of hot flushes. However some women are not candidates          for hormone replacement therapy for medical reasons or for choice.        -  Main goal: Reducing the number of hot flushes per week        -  Materials and Methods: A double-blind sulpiride versus placebo that includes selected          randomized patients which show symptoms of menopause. Study conducted at Hospital de          Clínicas de Porto Alegre (Brazil) for 8 weeks of intervention. The expected result is a          significant reduction in the number of hot flushes / day evaluated by daily          questionnaires   "
40941|NCT02749734|"     The purpose of this study was to determine the safety and therapeutic effect of sub-retinal     transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in     patients with macular degeneration diseases, and explore new treatment modalities for macular     degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).   "
40942|NCT02749721|"     The purpose of this study is to explore patterns of Brain Network Activation (BNA) changes     from baseline to endpoint on 1) efficacy of core symptoms of Major Depressive Disorder (MDD)     and 2) improvement of cognitive dysfunction with acute treatment with flexible dose     vortioxetine in adult outpatients with MDD and subjective complaints of cognitive     dysfunction.   "
40943|NCT02749708|"     The purpose of this study is to evaluate the use of IRX5183 in 1) patients with relapsed     and/or refractory AML and 2) patients with high-risk MDS or chronic myelomonocytic leukemia     (CMML).   "
40944|NCT02749695|"     The placental drug Melsmon® is effective for correction of insomnia and other climacteric     symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and     Placebo, but it was more significant in patients who used Melsmon®.   "
40945|NCT02749682|"     The purpose of this study is to asses the effect of chronic constipation on formation of     inguinal hernia using Constipation Severity Scale.   "
40960|NCT02749487|"     Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status .     It is a cost effective and readily available , and simply calculated , so that why     investigators try to use it as a predictor of short term survival in the critically ill     patients   "
40946|NCT02749669|"     For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the     emergency unit. They are described as inappropriate hospitalization because they don't     require the use of technical platform or diagnostic neither therapeutic procedures under     medical supervision. Those are inappropriate because the patient could have a paramedical and     social care at home or in more efficient structures. The hospital remains the place of remedy     for social and health situations whose resolution was not possible because of a lack of     infrastructure available, of patient or his relative information, or a lack of coordination     in medico-social establishment.      These inappropriate hospitalizations involve an increase of length of stay that enhancing the     fragility and vulnerability of the elderly. They have deleterious effects as decompensation,     comorbidities and loss of autonomy.      Moreover, the suffering of natural or informal caregivers is also an important public health     question; Caregivers may have a serious disease resulting from caring their relative. That     leads to increase their consumption of health care and medical goods.      This comprehensive study will highlight the deficiencies of the actual health care through     the analysis of the speech of the different parts involved (main study). Simultaneously, a     comparative analysis of the costs of health care will be conducted (economic combined study).   "
40947|NCT02749656|"     The purpose of this study is to evaluate efficacy and safety of 0.25% Desoximetasone cream     (Topoxy®) compare with 0.25% Desoximetasone cream (Topicorte®) in the treatment of scalp     psoriasis.   "
40948|NCT02749643|"     Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on     functional outcome measures of upper limb prosthetic users.   "
40949|NCT02749630|"     This study is a randomized, observer-blinded, placebo-controlled study to evaluate safety,     tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV)     UTTR1147A. The study will consist of a repeat dose escalation in healthy volunteers (HV) and     a repeat dose escalation in Ulcerative Colitis (UC) patients across multiple sites.   "
40950|NCT02749617|"     This pilot study will investigate the impact of dexamethasone (DEX) on anti-Xa levels in     participants taking apixaban 2.5 mg twice a day by mouth (PO BID). Investigators propose a     prospective, cohort study of 24 participants with multiple myeloma, in whom a     lenalidomide-dexamethasone (LEN-DEX)-based myeloma treatment regimen is indicated. Eligible     participants will initiate thromboprophylaxis with apixaban prior to starting their     DEX-containing regimen and continue until the end of cycle 3. Anti-Xa levels, D-Dimer and     plasma drug concentration will be measured.      This pilot study looks to investigate this potential interaction between apixaban and     dexamethasone to see if it warrants further investigation in a larger study.      The sample size of 24 provides 90% power to detect a primary outcome of ≥ 50% reduction in     peak anti-Xa levels from baseline. Secondary outcomes include changes in plasma apixaban     levels, D-dimer, and symptomatic venous thromboembolism (VTE) and bleeding during a 3-month     treatment period.   "
40951|NCT02749604|"     GreenLight laser PVP currently gains wide acceptance as a minimally invasive treatment for     benign prostate enlargment and the emergence of ejaculatory sparing techniques made it     feasible to get both benefits: relief of lower urinary tract symptoms and preservation of     ejaculation. However evaluation of actual infravesical de-obstruction following such     techniques remains a grey zone in the literature without an objective assessment of the     degree of de-obstruction. Furthermore, the impact of maintaining ejaculation on different     domains of the sexual function using comprehensive assessment tools was not compared in     ejaculatory sparring vs. non-ejaculatory sparring approaches.   "
40952|NCT02749591|"     The aim of this study will be to determine and compare the immediate and longer-term effects     of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and     robot-assisted therapy.   "
40953|NCT02749578|"     The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of     atorvastatin in healthy male subjects and female subjects not of child-bearing potential.   "
40954|NCT02749565|"     The investigators will compare the circulating fibrocyte proportion in asthmatic patients     with obstructive sleep apnea (OSA) and not with OSA In addition, the investigators will     compare the expression of epidermal growth factor receptor (EGFR), endothelin A receptor     (ETAR) and connective tissue growth factor (CTGF) The association of those factors and annual     decline of forced expiratory volume in 1 second (FEV1) will be performed   "
40955|NCT02749552|"     Obesity is a prevalent, destructive, and costly chronic disease. In 2008, 37% of Canadian     adults were measured as overweight, and 25% as obese. Obesity is a risk factor for a number     of serious health problems, including type 2 diabetes, asthma, gallbladder disease,     osteoarthritis, chronic back pain, several types of cancers (i.e., colorectal, kidney,     breast, endometrial, ovarian and pancreatic cancers) and cardiovascular disease (i.e.,     hypertension, stroke, congestive heart failure and coronary artery disease). In 2008, it was     estimated that the annual economic burden of obesity in Canada was $4.6 billion. Given the     economic strain and widespread health risks of obesity, there is a clear need to provide     effective interventions for obesity.      The purpose of the proposed study is to examine the role of ACT-based interventions in     long-term weight maintenance. The proposed study will examine the role of value consistent     behaviour, acceptance skills, and mindfulness skills in promoting long-term weight-related     health behaviours. Acceptance and Commitment Therapy (ACT) is an empirically supported     psychological intervention that emphasizes value consistent behaviours, acceptance skills and     mindfulness skills.   "
40956|NCT02749539|"     Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder     problems.   "
40957|NCT02749526|"     Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC     neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.   "
40958|NCT02749513|"     The purpose of this study is to demonstrate that orally administered itraconazole, a commonly     used antifungal medication, can inhibit Hedgehog pathway signaling in patients with     esophageal cancer, including adenocarcinoma (EAC) and squamous cell carcinoma (ESCC).   "
40959|NCT02749500|"     The purpose of this study is to test the hypothesis that early independent adaptive     bimanual-to-unimanual training of arm and hand movements, assisted with specially designed     mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor     control and function in patients with post-stroke hemiparesis.   "
40962|NCT02749461|"     The aims of this validation study are the testing of the Bernese Pain Scale for Neonates'     (BPSN) psychometric properties. The variability of pain reactions related to behavioral and     physiological patterns across time will also be examined. Furthermore, the influence of     contextual factors on the variability of pain reactions across gestational age groups will be     explored. The results will be used for modifications of the BPSN to account for contextual     factors in future clinical pain assessment in neonates.   "
40963|NCT02749448|"     Background: Sulfur mustard (SM) is a potent alkylating agent that targets several organs,     especially lung tissue. SM exposure leads to serious changes in morphological structure of     airway system, which is associated with chronic obstructive pulmonary deficiency following     exposure to SM. With extensive progress and achievements in tissue repair through stem cells     therapy, consideration of lung tissue has been increased due to the high prevalence of     pulmonary problems. Several factors such as selection of cell types, required conditions for     growth and proliferation of stem cells, and the process of entering into the body to repair     damaged lung tissue are considered as the most important problems in this issue. Accumulating     studies, both in animals and human with mesenchymal stem cells (MSC) support the hypothesis     of therapeutic effects of these cells in various disorders. In this study investigators aimed     to evaluate safety and potential efficacy of systemic MSC administration for treatment of     chronic lung injuries in SM-exposed patients.      Methods: Patients will receive 100 million MSC cells every two months for three injections     within 6 months. After each injection, parameters including safety, pulmonary function     testing (PFT), quality-of-life indicators, 6 minute walk test (6MWT), and expression of     inflammation and oxidative stress genes will be evaluated.   "
40964|NCT02749435|"     A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to     evaluate if the provision of a digital disease management tool improves glycaemic control in     participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End     of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for this     study will be conducted as part of normal, standard care. The main objective of this study is     to evaluate the effect of adding this tool to participants' current standard care for T2DM on     glycaemic control, other variables of importance in T2DM (eg, weight, blood pressure, and     lipid levels), and participant-reported outcomes (PROs), such as satisfaction with treatment     and adherence to their antihyperglycaemic treatment   "
40965|NCT02749422|"     This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility and     explore the neurophysiologic and clinical effects of repetitive transcranial magnetic     stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of a     control group will be used to see whether epilepsy patients, who suffer from a higher degree     of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can benefit     from a TMS intervention can benefit as much as a healthy matched population. Investigators     will also be looking at functional connectivity between the hippocampus and cortical regions   "
40966|NCT02749409|"     Patients diagnosed traumatic rib fracture and need admission will be included. Patients will     be divided two groups.The experimental group will be given parecoxib after visiting emergency     department. The control group will be given Narcotic agent such as morphine for pain control.     The outcome such as numerical rating scale (NRS) and hospital length of stay will be     recorded.   "
40967|NCT02749396|"     Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult     females in their childbearing ages. Little evidence is available regarding the association     between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four     marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry.     Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study     to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β     products for comparison with the ongoing European IFN-β Pregnancy Registry.   "
40968|NCT02749383|"     This study is a Phase II, single center, randomized, double-blind, placebo-controlled study     in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of     the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle     for up to 4 weeks.   "
40969|NCT02749370|"     evaluate the efficacy of etanercept in adult subjects with moderate to severe plaque who have     failed therapy with apremilast (Otezla)   "
40970|NCT02749357|"     INTRODUCTION:      The ability to move and transfer own body in an effective manner, is frequently affected in     people with a spinal cord injury with a negative impact in mood and quality of life, in such     a way, that achieving an effective locomotion, is one of the main objectives in the     rehabilitation program in a spinal cord injured patient.      There are different modalities of locomotion training in spinal cord injury, being the     robotic orthosis among them, and offering until now, positive outcomes. However there´s still     a lack of evidence of the optimal training characteristics, in order to establish the best     time, number of sessions, and progression scheme. For these reasons, establishing the effects     of different locomotion training programs will provide the necessary data in order to develop     an effective training program for the maximum benefit of the patient.      OBJECTIVE To determine the effect of different training programs with robotic gait orthosis     for patients with chronic motor incomplete spinal cord injury (SCI) (American Spinal Injury     Association Impairment Scale (AIS) C / D) in short and long term.      METHODS AND DESIGN. The design of the study consists on a randomized, blinded to the     observer, clinical trial.      Patients from the National Institute of Rehabilitation (INR) with spinal cord injury, AIS C     and D, with at least 6 months of evolution, and who are able to walk with or without gait     auxiliary, will be eligible.      Informed consent will be obtained from all subjects prior to participation. Patients will be     randomly assigned to either one of the two different training groups: intervention or control     group.      The control group will be submitted to training sessions of 30 minutes, and the intervention     group will have training sessions of 60 minutes.      Both groups will receive a training period of six weeks, five days a week.      Throughout the training period, gait assessments with the GaitRite instrument, will be     performed, and repeated at 6 and 12 months after completion of the training as part of follow     up. The data obtained from the GaitRite will be compared within each group, in order to     determine which type of training is more effective      Statistical analysis will be performed using SPSS, considering all P < 0.05 as statistically     significant.   "
40971|NCT02749344|"     This is a pilot study of a novel protocol for preparation of the endometrium for     frozen/thawed embryo transfer whereby estrogen is not administered during the proliferative     phase and progesterone is administered through vaginal suppositories in accordance with     endometrial thickness only, disregarding the day of ovulation. Progesterone supplementation     commences once the endometrium is at least 7 mm, a follicle is demonstrated on TVS, and     ovulation has not yet taken place. The day of ET is scheduled according to the unit's working     days and progesterone suppositories are commenced 48 hours before the scheduled embryo     transfer.   "
40974|NCT02749305|"     This qualitative study will identify which domains are most important to metabolic and     bariatric surgical patients, their families/partners, and their caregivers and which valid     patient-reported outcome measures (PROMs) will best capture this information. Patient and     caregiver feedback will be gathered on the local, regional, and national implementation PROMs     in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program     (MBSAQIP) as well as on patient-reported results and data presentation.   "
40975|NCT02749292|"     The purpose of this study is to determine the best management strategy to maintain remission     in patients with ANCA vasculitis who have been treated with rituximab induced B cell     depletion for at least two years. This study will compare intermittent B Cell depletion upon     B cell return or intermittent B cell depletion upon serologic relapse.   "
40976|NCT02749279|"     The most important drugs for evidence based lipid lowering treatment (LLT) in CHD are     statins. All patients with established CHD should be treated with statins irrespective of low     density lipoprotein (LDL) cholesterol (LDL-C) levels. The goals of treatment are LDL-C below     1.8 mmol/L (70 mg/dL) or 50% LDL-C reduction when target level cannot be reached.     Unfortunately, several patients cannot achieve treatment targets also related to the serious     problem of adherence to therapy, which includes also LLT.   "
40977|NCT02749266|"     The purpose of this pilot study will be to assess the impact of chiropractic Activator     adjustments on spatial cognitive abilities through initial assessment and testing in a     healthy population aged 18 to 35.   "
40978|NCT02749253|"     This pilot study is designed to investigate the feasibility of sudarshan kriya yoga (SKY)     program in adults with post traumatic stress disorder (PTSD) resulting from a wide range of     trauma experience.      SKY incorporates standardized collection of breathing techniques which are known to     positively influence the autonomic nervous system and stress response system. Both these     systems are dysregulated in PTSD.   "
40979|NCT02749240|"     At risk youth face various adversities including homelessness, social isolation, substance     abuse and other mental illnesses. Thus far, the investigators have successfully partnered on     programs of housing, social and recreational interventions in this population. The     investigators now wish to assess the feasibility of delivery of an innovative     bio-psycho-social intervention, Youth Empowerment Seminar (YES!), developed by their partner,     the not-for-profit Art of Living Foundation. Therefore, the aim of this research is to     conduct a proof of concept study to determine the feasibility of a novel YES! program as an     intervention for at risk youth.   "
40980|NCT02749227|"     This is a phase II, open-label, 12-month pilot study in 10 patients with silent corticotroph     pituitary tumors testing the hypotheses that Pasireotide LAR (long-acting release) treatment     of patients with silent corticotroph pituitary tumors and elevated plasma Proopiomelanocortin     (POMC) levels will reduce plasma POMC levels and this will be associated with a reduction in     pituitary tumor size. Pasireotide LAR 40 mg will be administered monthly. Baseline and     monthly visits on therapy will monitor plasma levels of POMC, other pituitary function,     safety labs, glucose tolerance, physical examination, and visual fields. Pituitary magnetic     resonance imaging (MRI) will be done at baseline, 6 months and 12 months of therapy. The     eligible patient population will consist of adult patients with known silent corticotroph     pituitary tumors and elevated plasma levels of POMC.   "
40981|NCT02749214|"     The purpose of this study is to determine the potential for a Parkinson's Disease (PD)     -specific breath signature as a non-invasive screening tool for identifying PD patients with     inflammation, tracking the progression of disease, and responsiveness to various therapeutic     interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological     disorders include any disorder involving the brain or the nervous system, for example memory     disorders, stroke, movement disorders and many other conditions.      The study will lay the foundation for future studies in which breath fingerprinting could be     used as a screening technique. Investigators will also be looking at how the breath     fingerprint correlates with inflammatory proteins in the blood.   "
40982|NCT02749201|"     To assess gastric wall thickness using transmitted light intensity.   "
40983|NCT02749188|"     The urinary tract infections are common in children. It is estimated that about 3% of girls     and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt     diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae.      Currently, there are different methods of urine collection, such as suprapubic aspiration,     the survey, the collection bag and the jet medium collection.      They have in common to be time-consuming, invasive in some cases, providers of contaminated     levies for others and impossible in children incontinent for the last.      A Spanish study developed a new collection technique, for kidney and bladder stimulation,     noninvasive, in the new-born to 30-day months. The results are promising with a success rate     of over 85% within a period of about 45s.      No study has looked at a broader pediatric population, including children from birth to age     of acquisition of walking.      We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in     infants who have not acquired the works for which a urine sample is required.   "
40997|NCT02749006|"     Bipolar-I Disorder is a common condition that is characterized by periods of mood elevation     however periods of chronic and recurring depressive episodes are more common and can be     severely disabling. Effective treatments exist, however a significant portion of bipolar     depressed patients do not respond to, or have difficulty tolerating many of these     interventions. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive     neuromodulatory technique that is effective in major depression and there is evidence for its     efficacy in bipolar depression which needs to be assessed in larger randomized controlled     trials. This study is a randomised, double-blind, sham-controlled trial over four weeks. The     primary objective is to assess improvement in depressive symptoms in acute bipolar-I     depressed patients on treatment with intermittent Theta-Burst Stimulation (iTBS) in     comparison to sham-rTMS.   "
40998|NCT02748993|"     This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in     children with atopic dermatitis.   "
40999|NCT02748980|"     The purpose of this study is to investigate the prevalence and degree of coronary arterial     microcirculaiton dysfunction of non- obstructive coronary artery disease in patients with     type 2 diabetes. Furthermore, the risk factors of coronary arterial microcirulation would be     screened and identified.   "
40984|NCT02749175|"     Cricoid force is applied during airway management to prevent pulmonary aspiration of     regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia     assistant. Currently this is performed WITHOUT monitoring and the force applied is determined     by the individual's educated hand that is derived from his/her experience from past     training and practice. Studies have shown that the actual force applied by nurse and     anaesthesia assistant is inconsistent and deviates from the optimal force. Under application     of cricoid force results in ineffective cricoid pressure and the risk of pulmonary     aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia,     long Intensive Care Unit stay and even death. Over exertion of cricoid force results in     distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion     and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation     crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on     manikin with and without direct feedback. Nurses were instructed to apply a range of force of     30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was     used. Unblinded nurses performed significantly better with feedback using the load sensor     then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid     force is developed to give feedback and guide the operator to exert and maintain the TARGET     cricoid pressure during rapid sequence induction (RSI).      In this study we aim to verify the sensor system with a manikin and compare the forces     applied by nurses with the sensor system and without.   "
40985|NCT02749162|"     The effect of perineural dexamethasone administered as an adjuvant in prolonging the duration     of analgesia continues to be under debate. The investigators performed a prospective     randomized study to evaluate the effect of perineural dexamethasone in different     concentrations in postoperative analgesia in femoral nerve block for anterior cruciate     ligament reconstruction.   "
40986|NCT02749149|"     This study will assess the benefit in using a frailty score to quantify accurate risk     pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity     and disability-free survival post-operatively.   "
40987|NCT02749136|"     The purpose of this study is to assess the feasibility and efficacy outcomes of neoadjuvant     modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable     pancreatic cancer.   "
40988|NCT02749123|"     A comparison of transdermal patches for efficacy, side effects and quality of life for     patients with back pain and arthritis. The three arms in the trial were; prescription     strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.   "
40989|NCT02749110|"     This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to     the French opportunistic cervical cancer screening program, of an organized screening with     the proposition by the family physician of a pap-test (usual care) versus a self-collected     vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized     in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that     organizing the screening for these women involving their family physician will major     participation, and that the self-sampling option will amplify this increase.   "
40991|NCT02749084|"     This is a INTERVENTIONAL TRANSPLANTATION STUDY WITHOUT DRUGS.      The INTERVENTION is represented by the INFUSION of DONOR T REGULATORY CELL-ENRICHED     LYMPHOCYTES to PATIENTS suffering from REFRACTORY CHRONIC GVHD after ALLOGENEIC HEMATOPOIETIC     STEM CELL TRANSPLANTATION.      The study includes a DOSE ESCALATION PHASE followed by a MTD PHASE as detailed in the     following chapter.      The primary objective of the dose escalation study will be SAFETY, leading to the definition     of the MTD of T reg cells. For the MTD study the primary objective will be the OVERALL     RESPONSE RATE at three months after the 3rd Treg infusion.      The study is single center single arm open label and includes a DOSE ESCALATION phase     followed by an EXTENDED PHASE with the MAXIMUM TOLERATED DOSE (MTD).      The aim of the study is to assess whether multiple infusions of donor-derived purified T     regulatory cells (T reg DLI) in patients with steroid-refractory chronic GVHD is safe and     whether it may induce clinical remission of GVHD.   "
40992|NCT02749071|"     The purpose of this investigation is to demonstrate the safety and effectiveness of Lower     Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease     (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study.     After the implant procedure, subjects will be randomized to either the Treatment Group     (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an     additional open-label phase in which all subjects will receive electrical stimulation.     Subjects continue on stimulation treatment in an extended open-label follow-up phase through     5 years post-stimulation.   "
40993|NCT02749058|"     The purpose of our study is to evaluate the differences in functional activities and     proprioception after surgery in subjects who underwent hip prosthesis implant with     capsulotomy or capsulectomy.   "
40994|NCT02749045|"     The overall purpose of this research study is to identify the disparity in ischemia     measurement between fractional flow reserve (FFR) used in the cardiac catheterization     laboratory and myocardial perfusion stress- single-photon emission computed tomography     (SPECT). This study aims to determine the correlation between simultaneous FFR and SPECT     obtained using regadenoson in the catheterization laboratory.   "
40995|NCT02749032|"     The present study is a phase I, single-centre, double-blind, randomized, cross-over (3     treatments, 3 treatment periods and 6 sequences), stratified (background medication:     metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on     treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out periods     between treatment periods lasting 21 days minimum.      The study was designed to directly compare the effects of vildagliptin and sitagliptin on     incretin hormone responses, glycaemia, and insulin as well as glucagon secretory responses in     patients with type 2 diabetes.   "
40996|NCT02749019|"     This is an open-label positron emission tomography/computed tomography (PET/CT) study to     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in breast     cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be     injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT     images.   "
41000|NCT02748967|"     The purpose of this study is to assess the safety and tolerability of different doses of     ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20     years of age.   "
41002|NCT02748941|"     Cerebrovascular accident (CVA) constitutes a major health public problem. This represents the     second cardiovascular death cause. CVA is ischemic in 80% of cases. Atheroma of large     arteries, mainly carotid, is involved in about 20% of cases.      After several high grade studies (NASCET, ECST, ACAS, ACST), carotid surgery is based on     stenosis calculation by Doppler ultrasound, CT angiography, MRI angiography or arteriography.      The composition of the plaque, showing its vulnerability, is associated with embolic risk and     stroke. The therapeutic strategy based only on the narrowing of the arterial lumen is not     satisfactory enough to prevent the occurrence of a transient ischemic attack (TIA) or an     ipsilateral stroke due to carotid stenosis. Thus, new techniques emerge, to evaluate in vivo     the inflammation of the plaque, its embolic consequences or the mechanical stress it     undergoes. These techniques are: High Resolution MRI (HR MRI), evaluation of the Gray Scale     Median (GSM) level, study of the plaque vascularization with Contrast Enhanced ultrasound     (CEUS), High Intensity Transient Signals (HITS) by transcranial Doppler, micro RNA profile     (mi RNA). These different modalities must be combined in order to increase the efficiency.      Based on these encouraging results, the investigator aim at evaluating the ability of     different methods or their combination to predict the occurrence of ischemic stroke or TIA     due to emboli from a carotid atherosclerotic plaque. Before considering a cohort study, he     investigator want to evaluate the performance of each of these new methods in the     characterization of carotid plaque instability. Performance evaluation will allow us to     choose secondarily the most relevant association.      The investigator propose, as a first step, to make a case-control study with these methods,     the cases are patients who had an ischemic stroke (authenticated by both the clinical exam     and brain MRI) on the same side as the carotid stenosis and the controls are patients with     carotid stenosis but without ischemic stroke. This study is a cross-sectional study because     it simultaneously measures the occurrence of the event (ischemic stroke) and the     characteristics of the atheromatous plaque.      Over a 2 year period, 45 symptomatic patients and 105 asymptomatic patients will be included     with a carotid stenosis with at least a 50% caliber constriction according to NASCET     criteria. (North American Symptomatic Carotid Endarterectomy Trial).   "
41003|NCT02748928|"     Prospective, one arm, baseline-controlled, clinical study for the evaluation of the     UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat     and circumference reduction.   "
41004|NCT02748915|"     The primary objective of this research is to evaluate the relationships between multiple data     from cochlear implant (CI) adult users to and to estimate predictive models of their fitting     parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP)     will be collected intra-operatively and the correlation with demographic data (deafness     duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory     performances and subjective measures used for implant fitting (hearing threshold and most     comfortable level) will be calculated. In a second group of experienced users (more than     9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR)     will be collected after 9 months of CI experience and after 12 months or more of use.     Correlation analyzes with demographic data, performance and fitting parameters will be     performed as well. Statistical predictive models for both fitting at the activation or in     experienced users should be developed according to the correlation analysis.      The secondary objective is to evaluate the effects of simultaneous stimulation on hearing     performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in     patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural     condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and     compared in the different conditions.   "
41005|NCT02748902|"     The purpose of this study is to determine if ingenol mebutate 0.05% gel is safe and effective     in treating common warts on the hands.   "
41006|NCT02748889|"     This is an open-label study with two parts, a Phase I study and a randomized Phase II study.     This study will be conducted at approximately ten sites in the United States. Approximately     178 patients will be enrolled in this trial.   "
41007|NCT02748876|"     Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients     with severe heart failure to improve symptoms and survival. Approximately one third of     patients treated with CRT do not notice significant improvement in their symptoms and this     may be due to inadequate co-ordination between the upper and lower chambers of the heart     (atrioventricular dyssynchrony).      The investigators propose a new method to achieve atrioventricular synchrony in CRT based on     measurements of electrical conduction from within the heart. Patients referred for CRT     implantation at Castle Hill Hospital are eligible to participate. During CRT implantation,     additional measurements, will be recorded from within the heart. After implantation, device     settings will be adjusted to either standard or electrophysiologically-optimised settings     with cross-over at 4 months.      The investigators hypothesis is that patients with optimised settings will derive additional     benefit compared to patients with standard pacemaker-determined settings.   "
41008|NCT02748863|"     The aim of the study is to demonstrate efficacy, safety and tolerability of 2 mL pre-filled     syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.   "
41009|NCT02748850|"     Aldehyde dehydrogenases (ALDHs) are cellular enzymes responsible for detoxifying aldehyde     resulting from the metabolism of endogenous and exogenous xenobiotic cellular constituents.     Although ALDHs are considered to play an important role in tumorigenesis, the role of ALDH     activity in cancer stem cells, and more particularly that of the acute leukemia must be     specified.      Several studies have shown that ALDHs are potent apoptogenic compounds on normal or cancer     cells. Therefore, the cells that were damaged and their increased ALDH activity does not die     by apoptosis but become highly proliferating. This result is a plausible mechanism for the     evasion of apoptosis, a characteristic shared by many cancer cells.      On this basis, it is proposed an innovative approach to cancer chemotherapy through     inhibition of one of the protective mechanisms against apoptosis, ie the increase in ALDH     activity than cancer cells put involved in overcoming the lethal effects of damaged roads.     ALDHs of inhibitors they may have immediate application as anti -cancer in vivo? The limited     experimental data obtained so far on human tumor xenografts in immunodeficient mice and the     absence of data on the in vivo toxicology do not allow direct passage to clinical trials.     Indeed, some members of the ALDH superfamily are expressed constitutively in some vital     organs they protect against the deleterious effects of xenobiotics and adverse endogenous     metabolites. Consequently, if ALDHs should be inhibited, of the collateral damages for the     normal cells could occur. However, when normal cells have not undergone deleterious exposure,     these harmful metabolites are not or in very small quantities, which do not require high     levels of ALDH activity, and therefore without harm to the inhibition of cell of these     enzymes.      From a hematological point of view, it seems essential to test the therapeutic index of the     inhibitor of ALDH DIMATE between normal hematopoietic cells and leukemic stem. Indeed, in the     pathophysiology of acute leukemia, the leukemia stem cells are of major importance because     they are much more resistant to chemotherapy than more differentiated cells and thus causing     the high rate of relapse observed in acute leukemia despite the high rate of complete     remission often obtained. In this study, it will be tested in vitro sensitivity of the     cluster of differentiation 4 and cluster of differentiation 38 (CD4/CD38) highly purified of     leukemic origin or normal to the DIMATE compound. The objective will be to analyze the     effects of DIMATE on the parameters of the proliferation, the apoptose, the cytokinins of     secretions and the changes transcriptomic in general, in order to better define the     therapeutic index of this compound and to determine all the precursory hematopoietic normals     and leukaemic cellular effects. The reversible cytostatic of DIMATE effect on normal cells     but its irreversible apoptotic effect on cancer cells is an advantage to try to eliminate.   "
41010|NCT02748837|"     This is the open label, multicenter Phase 1 study which consists of a dose escalation to     determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary     evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican     3 positive advanced solid tumors until unacceptable toxicity or disease progression.   "
41012|NCT02748811|"     GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail,     elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive     geriatric assessment and intervention before and during treatment with chemotherapy.      The hypotheses are: Optimizing the health conditions and functional status of frail elderly     patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will     lead to a higher grade of completing the planned chemotherapy and at higher dose intensity.     This will also result in a higher overall survival and improve quality of life.   "
41013|NCT02748798|"     The goal of this research is to optimize the MRI system to obtain ideal lung images using     Hyperpolarized (HP) Noble and Inert Fluorinated Gases as contrast agents. Lung coils tuned to     the frequencies of these gases will be used. This study will take place at TBRHSC in the     Cardiorespiratory Department and in the Research MRI facility.   "
41014|NCT02748785|"     To investigate whether a short term discontinuation of methotrexate (MTX) will improve the     vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease     activity in a randomized clinical trial.   "
41015|NCT02748772|"     The purpose of this study is to determine whether Endostar pumping into vein with Thalidomide     are more effective in the treatment of Advanced Colorectal Cancer (ACRC).   "
41016|NCT02748759|"     Anterior Cruciate Ligament (ACL) injuries by trauma are a prevalent pathology. In the USA,     about 200.000 injuries are estimated per year, half of which implicate a total rupture of the     ligament. Data indicates that the number of ACL injuries is increasing in young athletes and     presents a common problem, especially people playing agility sports.      One of the most widely used methods for the post-surgical mobilization after ACL is the use     of Continuous Passive Motion (CPM) devices. These machines are meant to drain residual fluid     from the articulation and maintain the mobility of the joint and muscles in the knee. Even     though studies show that, an early mobilization after surgery is beneficial to the     rehabilitation of the knee joint, recent studies are questioning the efficiency of the CPM     when compared with the goal of application. While literature suggests that efficacy of CPM     are related with the magnitude of knee flexion and the Range of Motion (ROM) achieved some     studies show that the range of motion measured by the CPM is considerably less than the     actual ROM.      As other therapy that provides an effective mobilization of the knee joint, the Specific     Manual Physical Therapy method (Kaltenborn method) takes in account the physiological     combination of rotation and gliding of the two joint surfaces. This technique mobilizes the     femorotibial joint by controlling the tibial plateau anteroposterior during flexion and     posteroanterior during extension of the knee. Therefore, in the past 30 years there are not     studies comparing ROM measurements obtained with CPM and manual physical therapy methods.      It is hypothesized that the benefits of the early passive mobilization after ACL     reconstructive surgery are diminished by the limited efficacy of currently used CPM devices.     The aim of our study was to determine the range of motion achieved with the passive     mobilization using a CPM device compared with a manual method (Kaltenborn method) and to     assess that ROM measurements provided by the CPM correlates the real ROM.   "
41017|NCT02748746|"     Bio-electrical impedance analysis and Tissue Dielectric Constant measurements are objective     methods in clinical usage to detect lymphedema in early stage. The aim of this study is to     reveal comparative relation these two methods on detecting lymphedema in an early stage.The     another aim of this study is to determine impedance ratios and lymphedema index (L-dex) by     using bio-electrical impedance analysis in patients after breast cancer surgery.   "
41018|NCT02748733|"     The purpose of this study is to validate the concept of adapted automated PD a modified     Peritoneal Equilibration Test (PET), will be performed in children on chronic PD. Instead of     a single 4 hour standard dwell, two double mini PET using the same type and total volume of     dialysate and the same total dwell time (150min) will be performed in randomised sequence. An     double mini test consists of two identical dwells, reflecting routine PD, the other one of a     short small dwell followed by a long, large dwell as suggested from adapted PD regimes     successfully applied in adult PD patients.   "
41019|NCT02748720|"     Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the     time of transition at birth. For that stabilization during resuscitation is successful, it is     essential for proper ventilation. This transition is performed with non-invasive respiratory     support and administration of positive pressure ventilation to establish adequate functional     residual capacity. The problem is that a peak inspiratory fixed during ventilation, and     adequate tidal volume is assumed, but usually not measured, unable to correct the peak     pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events     may hinder or impair the effectiveness of the ventilation, with the consequent deterioration     in the prognosis of the newborn.   "
41020|NCT02748707|"     This is a phase II randomized clinical trial to study the effect of COX-2 inhibitor Celecoxib     and EGFR tyrosine kinase inhibitor Erlotinib alone or in combination on molecular markers of     apoptosis and angiogenesis.   "
41021|NCT02748694|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)     of TAK-041 following oral single and multiple doses in healthy participants.   "
41022|NCT02748681|"     Study Objectives:      Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in     stroke patients, with adherence rates for CPAP therapy of only 30%.      The primary objective of this study is to determine whether CPAP adherence in stroke patients     with obstructive sleep apnea can be improved by a CPAP training strategy during     rehabilitation combined with a telemedicine monitoring system after discharge.      The secondary objective is to compare recording quality as well as subjective and objective     sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in     the management of sleep apnea in stroke.      Further the investigators aim to study changes in nocturnal systolic blood pressure due to     CPAP therapy with the pulse transit time method.      Finally, the investigators intend to study the relationship between CPAP compliance, sleep     and medical and neurorehabilition outcome parameters.      Design:      Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared     with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to     severe OSA.      Setting: Neurorehabilitation center in Vienna, Austria      Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with     moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended     polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of     out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal     AHI< 10) at the neurorehabilitation unit.      Interventions: Patients will be randomized to either standard care with an autotitrating CPAP     device or an autotitrating CPAP device that transmits physiologic information (i.e.,     adherence, air leak, residual AHI) daily to a website that will be reviewed by their homecare     provider. If any problems are identified, the patient will be contacted by his homecare     provider by telephone. Neurologists performing sleep and neurological scoring will be blinded     to the randomization.      Measurements: Recording of the different measuring systems, subjective and objective sleep     quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP     determined by means of a non-linear algorithm and an individual one-point calibration of the     pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH, Germany)     and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.   "
41023|NCT02748668|"     The objective of the study is to predict outcomes of patients on extracorporeal membrane     oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to     clinical outcomes using data collected in the ECMO Registry at Spectrum Health.   "
41024|NCT02748655|"     The purpose of this study is to determine whether consumption of alkaline ionized water is     effective for accelerating sports recovery.   "
41025|NCT02748642|"     This randomized, observer-blinded, placebo-controlled, single and multiple ascending-dose     study will be conducted in two parts to evaluate the safety, pharmacokinetics, and     immunogenicity of BITS7201A. Part A will be an ascending, single-dose, sequential-group study     where participants will be randomly assigned to active drug or placebo. Part B will be an     ascending, multiple-dose, sequential-group study where participants will be randomized to     active drug or placebo. Total length of the study is anticipated to be approximately 12     months.   "
41026|NCT02748629|"     The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness     following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein     Operation with lightweight polypropylene mesh.   "
41027|NCT02748616|"     In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic     acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators     will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or     Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile     infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing     the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid     composition (80% deoxycholic acid) to maintain growth suppression.   "
41028|NCT02748603|"     An observational, retrospective, multicenter, blinded adjudication study to evaluate the     clinical appropriateness of Percutaneous Coronary Intervention (PCI) indication and execution     in patients with stable Coronary Artery Disease (CAD) and in patients with acute coronary     syndrome without ST-segment elevation (NSTE-ACS) (ratio 4:1). Half of the included patients     will be diabetic. Also the implementation of selected, key guideline recommendations will be     examined.      At least 400 patients will be retrospectively selected among 22 Catheterization Laboratories     in Italy in the region of Lombardia and Veneto.      This study will be conducted in compliance with Good Clinical Practices (GCP) including the     Declaration of Helsinki and all applicable regulatory requirements.   "
41029|NCT02748590|"     Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active     ulcerative colitis.   "
41030|NCT02748577|"     Primary Objective of this study: To assess experimental heat pain responses (pain intensity,     pain unpleasantness, pain catastrophizing, emotional reactivity) in migraineurs vs. healthy     controls.      The current tools of migraine pain measurement are inadequate to distinguish the overall     burden of suffering, as there is an over reliance on a single numerical pain score to     represent the entire pain experience. Measuring and targeting the affective component, in     addition to the sensory component of pain, may capture this discrepancy in disease burden.     The affective component of migraine pain may be just as important as the sensory component to     target and measure since it significantly impacts outcomes, disability, and has therapeutic     treatment implications.      Quantitative sensory testing (QST) is a robust lab paradigm (not a clinical experience) that     delivers one painful noxious thermal stimuli and asks for simultaneous pain intensity and     pain unpleasantness scores. By using this in the research, investigators will be able to     differentiate the sensory (pain quality—what the pain feels like) from the affective (how     awful/unpleasant the pain feels) components of experimental pain in normal controls vs.     migrainuers.      No previous studies have evaluated differences in experimental pain intensity vs. pain     unpleasantness in migraineurs vs. controls. As migraine pain uniquely involves many altered     sensory phenomenon (e.g., photophobia, phonophobia), it cannot be assumed that responses to     experimental pain in migraine will be the same as other clinical pain syndromes. Further,     different clinical pain syndromes have distinct responses to pain intensity vs. pain     unpleasantness.   "
41031|NCT02748564|"     This study will evaluate the safety and tolerability of IL-2 when given in combination with     pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells     to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the     ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may kill more     tumor cells.      There are two parts to this study:        -  Phase Ib: To determine the safety and side effects of increasing doses of IL-2 in          combination with pembrolizumab        -  Phase II: Once the maximum tolerated dose of IL-2 is determined, additional patients          will be treated to determine if it is effective against the cancer.   "
41032|NCT02748551|"     Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to     90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2     Lymphadenectomy is the main option for treatment. Conventional open approach is still the     current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as     minimally invasive surgery has gained popularity for the treatment of early gastric cancer in     East Asia. Several studies indicated that laparoscopic procedures both total and subtotal     gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by     experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on     the oncologic efficacy.      Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy     for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and     oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal     gastrectomy for treatment gastric cancer.   "
41033|NCT02748538|"     A randomised controlled trial to evaluate the effect of face-down posturing on retinal     displacement and distortion following retinal detachment repair.   "
41034|NCT02748525|"     This study aims to combine the use of IV CCK administration followed by oral milk during a     HIDA scan to further stimulate the gallbladder contractility and decrease the number of false     abnormal HIDA scans and unnecessary cholecystectomies in some patients.   "
41035|NCT02748512|"     A controlled, multi-center study to evaluate the utilization and safety of the MK II inserter     and the safety of the Fluocinolone Acetonide Intravitreal (FAI) insert in subjects with     non-infectious uveitis affecting the posterior segment of the eye.   "
41036|NCT02748499|"     This study aimed to test the effects of a 12-month Healthy Beat Accupunch (HBA) exercise     program on the perceived health status and sleep quality of the community-dwelling older     adults.   "
41037|NCT02748486|"     The purpose of this study is to determine whether modules of Metacognitive Training: Jumping     to Conclusions and To empathize... are effective in the treatment of patients with     schizophrenia. Also it was investigated whether these modules have specific impact on     cognitive biases severity.   "
41039|NCT02748460|"     This is a multi-centre, multinational, prospective, non-interventional study in females with     a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a     long term manner is planned, and in subjects who were previously exposed to UPA in the long     term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive,     eligible, patients will be invited to enrol from approximately 100-150 European Union (EU)     clinical practice sites in approximately 15 countries. Patients will be followed for an     observation period of 60 months (5 years) from treatment start. Investigators are to manage     and treat patients according to their standard medical practice.      The specific objectives of the study are to assess the long term safety, including     endometrial safety, of Esmya in standard medical practice and the prescription patterns of     Esmya in standard medical practice.      The exploratory objective is to assess patients' quality of life in a long-term treatment     setting.   "
41064|NCT02748135|"     The purpose of this study is to assess the safety and tolerability profile of TB-403     (humanized monoclonal antibody against placental growth factor (PlGF)) in pediatric subjects     with relapsed or refractory Medulloblastoma.   "
41040|NCT02748447|"     Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo     intensive care is an important risk factor for risk of neurodevelopmental impairment. Near     infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation.     Automated Fraction of Inspired Oxygen (FiO2) adjustment can maintain arterial oxygen     saturation (SpO2) within a target range and may reduce risk of fluctuation of cerebral     oxygenation.      Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2     within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to     SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with     supplemental oxygen.   "
41041|NCT02748434|"     Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy     through short-term continuous glucose monitoring has shown inconsistent results and it is yet     unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators     propose to enroll at least 20 people who participated in phase 1 and who were determined to     have subclinical lipohypertrophy to examine the correlation between glycemic control and     amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose     and continuous glucose monitoring.   "
41042|NCT02748421|"     In our study , the investigators will use the microscope with OCT ( Lumera with RESCAN OCT )     coupled to assess the extent , depth and change of retinal architecture in the perioperative     period . Thus , they will evaluate what the optimal maneuvers of dissection of macular     membranes to obtain a more satisfactory result of the rearrangement in the retinal layers .     Furthermore , the use of OCT perioperative may dispense with the use of dyes , decreasing the     concentration used or reduce the exposure time. Thus, they can get the potential decrease in     retinal toxicity may be generated by them.   "
41043|NCT02748408|"     This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.   "
41044|NCT02748395|"     The purpose of this study is to determine whether the injection of triamcinolone and     lidocaine is effective in relieving chronic abdominal wall pain.   "
41045|NCT02748382|"     Despite evidence of the physiologic benefits and possible lower mortality associated with low     chloride solutions, normal saline remains the most wildly used fluid in the world. Given     uncertainty about the impact of lower chloride versus higher chloride solutions on mortality,     it is unlikely that clinical practice will change without new and direct RCT evidence.     Editorials published in leading critical care journals have called for RCT's to address this     important clinical question. The proposed feasibility RCT will investigate the feasibility of     a large-scale trial directly comparing low chloride versus normal chloride for resuscitation     in septic shock on patient-important outcomes such as mortality and AKI.   "
41047|NCT02748356|"     As a collaborative effort between MedStar National Rehabilitation Hospital (NRH), Children's     National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI)     Center for Genetic Medicine Research, Georgetown University, and MedStar Georgetown     University Hospital, the overall objective of this study is to develop, validate, and assess     a patient-initiated, probiotic-based, selfmanagement protocol that is initiated at the time     of urinary symptoms. The self-management protocol will allow patients to manage urinary     symptoms and avoid potentially unnecessary antibiotic use, and provide a readily-available     means of maintaining health, function, and independence throughout the lifespan.   "
41048|NCT02748343|"     The purpose of this study is to compare use of a tissue-engineered bone to use of a standard     allograft bone to treat bone defect in patients. The hypothesis is that use of the     tissue-engineered bone is effective and safe to treat the bone defect in patients.   "
41049|NCT02748330|"     This will be a single-center, randomized, open-label, active-controlled, parallel-group study     to investigate the platelet inhibition of Ticagrelor versus Clopidogrel with acetylsalicylic     acid (ASA) as background therapy in approximate 40 patients with stable coronary artery     disease (SCAD) and type 2 diabetes mellitus (DM) after recent successful elective     percutaneous coronary intervention (PCI) by evaluation of the P2Y12 reaction unit (PRU) by     VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on treatment day 15±2.   "
41050|NCT02748317|"     As a collaborative effort between MedStar National Rehabilitation Hospital (NRH)/MedStar     Health Research Institute (MHRI), Children's National Medical Center (CNMC) Department of     Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, and     Georgetown University Medical Center, the overall objective of this study is to develop,     validate, and assess a patient-initiated, probiotics-based, self management protocol that is     initiated at the time of urinary symptoms. The self-management protocol will allow patients     to manage urinary symptoms and avoid potentially unnecessary antibiotic use, and provide a     readily-available means of maintaining health, function, and independence throughout the     lifespan.   "
41051|NCT02748304|"     The purpose of the study is to observe the effect of sorafenib combined with aspirin in     preventing the recurrence in high-risk patients with hepatocellular carcinoma.   "
41221|NCT02746055|"     To determine the prevalence of 5 specific corneal dystrophies in a subgroup of patients     seeking refractive surgery, and to use that information to inform them and their refractive     surgeons of the presence of the corneal dystrophies so that they may make safer choices when     considering refractive surgery.   "
41052|NCT02748291|"     There are over 8.75 million people in the United Kingdom with osteoarthritis in their knees.     The effect of this condition can be debilitating. Symptoms are due to wear and tear of the     knee joint. Some people can suffer with knee pain and stiffness. This study will look at     whether walking improves the symptoms of knee osteoarthritis.      Investigators will recruit anyone with knee pain over the age of 45 years in Nottingham.     Participants will undergo a full assessment by a qualified Doctor. After assessment,     Participants meeting the eligibility criteria will be invited to join the study. Participants     will be randomly allocated into 2 groups. One group will receive standard health and exercise     advice. The other group will be allocated a walking activity. This group will undertake 6,000     walking steps each day. Participants will provide pedometers to monitor this walking     activity.      The effect of walking will be compared using questionnaires. These will look at pain levels,     quality of life and physical activity. The participants will complete these questionnaires     before the study, at the 6 week midpoint and at the end of the 12 week intervention.   "
41054|NCT02748265|"     This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved     for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and     intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia     either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).   "
41055|NCT02748252|"     With aging of the persons living with HIV, cardiovascular diseases now account for     substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its     incidence doubles every decade over 55 years of age.      The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute     phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are     referred to these units in the first hours of a stroke and not to their infectious disease     units which is a loss of chance.      It would also be important to know whether HIV patients need specific protocols for stroke     emergency management.      The study aims to compare the functional prognosis after the first occurrence of an ischemic     stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by     HIV.   "
41056|NCT02748239|"     A new diabetes education program for the initiation of non-intensive insulin therapy in type     2 diabetic patients (MEDIAS 2 CT) was developed.      In the evaluation, this new developed program is compared with an education programs which is     currently used for diabetes education. It is expected that the new developed program (MEDIAS     2 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic     control. If non-inferiority can be demonstrated superiority of this program will be tested.   "
41057|NCT02748226|"     1. Study design: multicenter retrospective and prospective observational study        2. Study Cohort :             1. Retrospective cohort: This cohort retrospectively enrolls patients with lower               extremity artery disease who underwent endovascular treatment from January 2006 to               the date of approval by IRB in the participating hospitals. Informed consent was               waived by IRB.             2. Prospective cohort: This cohort prospectively enrolls patients with lower extremity               artery disease who undergo endovascular treatment from the date of approval by IRB               to July, 2018 in the participating hospitals. Informed consent will be obtained               prior to enrollment.        3. Baseline clinical and lesion characteristics, procedural and post-procedural data,          clinical outcomes, hemodynamic, and imaging follow-up data are investigated. Primary          patency and target lesion revascularization rates of the total cohort and patient          subgroups are evaluated. Risk factors of restenosis and target lesion revascularization          are determined.   "
41058|NCT02748213|"     This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin)     and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with     previously untreated HER2-positive advanced and/or metastatic breast cancer.   "
41059|NCT02748200|"     In this phase 1 trial, the investigators will prospectively evaluate 3 different external     beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to     40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of     abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of     fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is     delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a     simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3     different dose levels will be implemented in order to increase the biological equivalent dose     (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.   "
41060|NCT02748187|"     Cognitive behavioural analysis system of psychotherapy (CBASP) is one of the only     psychological models and treatments that has been designed specifically for patients     diagnosed with chronic depression. CBASP in combination with antidepressants has been found     to be the most effective treatment for chronic depression. Despite an increasing amount of     research into this intervention, researchers are less aware of the role that specific and     common ingredients are accounted for in outcomes. Given that CBASP is a treatment model     endorsed by the National Health Service Scotland (NHS Scotland), gaining a deeper knowledge     and understanding about the active ingredients involved in their success ensures current     practice is embedded in an evidence base. Conducting this research adds to the gap in the     literature and identifies areas in which further exploration is warranted. Given the emphasis     on therapist variables in relation to treatment outcomes, the results of this research will     have wider implications from a service resource perspective. Training may be altered or needs     emphasised in line with the results of the study to ensure most efficacious outcomes.      Limited research has looked at therapist and client variables that may contribute to     therapeutic alliance/engagement, and clinical outcomes. The current study proposes to explore     two variables that are hypothesized to contribute to outcomes based on the theoretical     framework CBASP is grounded on, namely therapist and client attachment style and reflective     functioning. This will be done by providing CBASP to a small number of participants and     gathering outcome data from therapists and clients at each therapy appointment. Participants     will also complete the Adult Attachment Interview (AAI), a semi structured interview which     can also be coded for reflective functioning. This is a proof of concept case series design     that aims to provide an analysis of individual psychological change in relation to the above     variables of interest.   "
41061|NCT02748174|"     This is a naturalistic study of 100 migraineurs and 75 post concussive headache patients who     will be asked to record their headaches, medications, sleep and other behaviors in a     smartphone app called Curelator. The software was developed to identify possible headache     triggers. We seek to determine whether there might be protective headache factors. Patients     will be given audio files with relaxation therapies. We seek to understand whether this self     relaxation therapy and/or traditional evidence based behavioral treatment recommended during     a patient visit is protective against migraine attacks.   "
41062|NCT02748161|"     Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and     are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization     (DEB-TACE). During the DEB-TACE procedure, very small beads are mixed in with a chemotherapy     drug, doxorubicin, and delivered to the tumor through an arterial catheter.      The DEB-TACE procedure allows the treatment to be delivered directly into the liver. It also     causes arterial embolization, the process in which a blood vessel is blocked. Treatment of     HCC using DEB-TACE may help delay tumor progression and can downstage (decrease the size) the     cancer in order to meet the criteria which may allow patients to become candidates for liver     transplantation. The purpose of this study is to compare tumor response and medical outcomes     for patients who undergo DEB-TACE with standard endhole catheter versus Surefire® Infusion     System.   "
41063|NCT02748148|"     The purpose of this study is to identify challenges and successes associated with     implementing an enhanced medication therapy management service in primary care practice.   "
41065|NCT02748122|"     This feasibility pilot is intended to understand whether adolescents with Type 2 Diabetes     (2DM) can be transitioned to a continuous subcutaneous insulin injection (CSII) and if so,     assess whether CSII is a feasible treatment modality and improves quality of life (QOL) in     adolescents with T2DM over 3 month period.   "
41066|NCT02748109|"     Our central hypothesis is that chronic balance deficits after mild traumatic brain injury     (mTBI) result from impairments in central sensorimotor integration (CSMI) that may be helped     by rehabilitation. There are two objectives of this proposal; the first objective is to     characterize balance deficits in people with mTBI. The second objective is to use a novel     auditory bio-feedback (ABF) device to improve measures central sensorimotor integration and     balance control.   "
41067|NCT02748096|"     Patient-specific instrumentation guides have previously been used to improving surgical     accuracy and ease of implantation during Total Knee Replacement but have received less     attention for implanting Unicompartmental Knee Replacement. The aim of this prospective study     is to compare the accuracy of implantation and functional outcome of mobile bearing medial     Unicompartmental Knee Replacement implanted with and without patient specific instrumentation     by experienced knee surgeons.   "
41068|NCT02748083|"     This trial attempts to evaluate the effects of intensive transcranial direct-current     stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting     state brain network connectivity, especially increasing connectivity in the tasks related     network, and increasing activation the DLPFC in a working memory task. Half of the     participants will be randomized to tDCS group, while the other half will be randomized to     receive sham tDCS.   "
41069|NCT02748070|"     While oral steroids have been shown to be effective in the management of patients with     chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without     polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit     in this disease state, steroids are often prescribed as a component of post-operative care     after sinus surgery for patients without polyps. Oral steroids carry with them significant     adverse effects, and should be prescribed thoughtfully. The aims of this study are to     determine if oral steroids in the peri-operative period improves patient outcomes in CRS     without polyps.   "
41070|NCT02748057|"     The study will assess the safety and tolerability of MK-0653H (Ezetimibe 10 mg+ Rosuvastatin     2.5 mg) and MK-0653H (Ezetimibe 10 mg+ Rosuvastatin 5.0 mg) through up to 52 weeks in     Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10     mg or Rosuvastatin up to 5 mg.   "
41071|NCT02748044|"     The prevention and treatment of diseases via artificial intelligence represents an ultimate     goal in computational medicine. The artificial intelligence for systematic clinical     application has not yet been successfully validated. Currently, the main prevention strategy     for rare diseases is to build specialized care centers. However, these centers are scattered,     and their coverage is insufficient, resulting in inadequate health care among a large     proportion of rare disease patients. Here, the investigators use deep learning to create     CC-Cruiser, an intelligence agent involving three functional networks: pick-up networks for     diagnostics, evaluation networks for risk stratification and strategist networks to     provide assisted treatment decisions. The investigator also establish a cloud intelligence     platform for multi-hospital collaboration and conduct clinical trial and website-based study     to validate its versatility.   "
41072|NCT02748031|"     Photography is considered as one of the most important means to promote evidence-based     medical practice in pediatric ophthalmology.This study is to investigate the feasibility of     congenital cataract morphological classifications and monitoring using slit-lamp-adapted     anterior segmental photography in a large cohort that included uncooperative children.   "
41073|NCT02748018|"     The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed     Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A     diverse population of patients with type 1 diabetes will be studied. The study population     will have a large range for duration of diabetes and glycemic control, as measured by     glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior     diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous     Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)   "
41074|NCT02748005|"     The study evaluates the effect of Fenugreek seed extract (Furosap) in management of     symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek seeds     extract are known to possess protodioscin and the extract is reported to improve sperm count,     sperm morphology and protective effect on male reproductive system. All the participants will     receive one capsule (500 mg) of furosap once a day.   "
41075|NCT02747992|"     Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after     breast cancer surgery when used in addition to general anesthesia or sedation. However, major     breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.   "
41157|NCT02746913|"     The purpose of this study is to compare two methods for assessing patients with pelvic organ     prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely     accepted and well-studied method for diagnosing occult stress urinary incontinence     preoperatively, but an ambulatory pessary trial is a less expensive option that is available     to a wider group of practitioners and evaluates patient while they are engaged in their daily     activities.   "
41076|NCT02747979|"     A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of     combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules     removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.      There are two phases of study for each subject. Phase 1 (screening phase). During this phase,     each potential subject will be evaluated to determine if he/she is eligible for the study.      Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per     week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3     months.   "
41077|NCT02747966|"     A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable     Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at     various age range and both sexes are recruited to observe their access flow, access     recirculation and cardiac function and assess their relationship.   "
41078|NCT02747953|"     The program will provide early access to the investigational drug gilotrif in patients with     advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or     gefitinib.      The Compassionate Use Programme will also provide additional safety information on gilotrif     use.   "
41098|NCT02747680|"     This research study is designed to investigate the effect of hypoglycemia (low blood sugar)     on blood flow to and biochemistry in the brain.   "
41079|NCT02747940|"     Brain signatures as objective measures of acute pain have been characterized with     functional magnetic resonance image and machine learning technology. As compared to acute     pain, chronic pain leads to greater socioeconomic burden. However, measures for chronic pain     remain subjective and suboptimal, and the brain signatures for chronic pain are largely     unknown. Chronic migraine and fibromyalgia are two prototypes primary chronic pain disorders     with high disability and intractability with prevalence of around 2% for both diseases. These     two chronic pain disorders have shared clinical presentations (abnormal pain sensitivity,     mood and sleep disorders), pathophysiology (central sensitization) and medical treatment     (anti-depressants), despite different body parts are involved (head vs. whole body). The     present integrated project aims to characterize both common and disease-specific brain     signatures of chronic pain by investigating these two chronic pain disorders. Our findings     may shed some light on the key mechanisms of pain chronification, and may pave the way for     the optimization of diagnosis and prognostication, as well as formulation of personalized     medicine in chronic pain, so as to improve life quality of these patients and to reduce     socioeconomic loss.      The present project includes three interdisciplinary sub-projects (plus one animal study, not     listed here):      A: Clinical studies for chronic migraine and fibromyalgia: endophenotypes and pain     chronification B: Functional neuroimaging of chronic pain: multimodal quantitative analysis     of brain connectomes C. Data stream mining technology for multimodal physiological signals of     chronic pain: real-time tracking and clinical correlation      The specific aims of the present projects include:        1. Identification of common and disease-specific brain signatures for chronic pain          (sub-projects A, B, C)        2. Investigation of clinical indicators with predictive values by machine learning analysis          of big data (sub-projects A, B, C)        3. Elucidation of the specific anatomical structures or neural networks underpinning pain          chronification based on clinical neuroimaging (sub-projects A, B) In this 1st-year pilot          study of the 4-year longitudinal study, we will establish experimental platforms for          each sub-project, start to recruit participants and perform endophenotyping, as well as          have a preliminary integration for sub-projects A, B and C.   "
41080|NCT02747927|"     The purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue     Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any     of the four dengue virus serotypes in 4 to 16 year old participants.   "
41081|NCT02747914|"     Leg spasticity is common problem encountered with a large proportion of patients suffering     with multiple sclerosis (MS) with an increasing severity as the disease progresses. It mostly     affects the antigravity muscles that significantly complicates transfer, increases fatigue     and makes walking more difficult. Hence, leg spasticity often interferes with patients'     mobility and significantly influences their quality of life. A great number of     multidisciplinary rehabilitation studies has shown a significant effect of numerous specific     functional changes in patients with secondary (SP) and primary progressive (PP) MS but there     are no reviews related to spasticity. The positive therapeutic effect of modulating     Transcranial Magnetic Stimulation ( TMS) methods on spasticity is shown in only two studies,     in patients with relapse remitting clinical form in the remission phase of the disease. The     effect of TMS on clinical measures of lower limb spasticity, functional inability and the     quality of life in patients with SPMS and PPMS will be examined in this study. The objective     to this study are to to explore whether rTMS boosted exercise therapy (ET) treatment can     bring more improvement in lower limb spasticity than ET treatment alone in these patients.   "
41082|NCT02747901|"     The investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on     muscle strength and functional performance outcomes in patients with TKA during early     postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to     control, KT and CT groups (nC=nKT=nCT=37).   "
41083|NCT02747888|"     Thyroid cancers can occur sporadically, but can also be found as tumors that cluster in     families with other cancers or genetic syndromes. Researchers are studying thyroid cancer in     children and families, with a particular interest in understanding genes and other factors     that may put individuals at risk for developing thyroid cancer and thyroid nodules.        -  In this study, family and medical history information is collected alongside a blood or          saliva sample for genetic studies.        -  Individuals with a past or present childhood thyroid cancer/nodule or a thyroid cancer          suspected to be inherited in their family are invited to participate.   "
41084|NCT02747875|"     The purpose of this study is to determine if methadone improves postoperative pain control in     pediatric patient's undergoing cardiac surgery.   "
41085|NCT02747862|"     The primary objective of this chart review study is to evaluate the outcomes of subjects with     Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous     Polyposis (FAP) who have not undergone surgical resection of the colon.      A secondary objective of this study is to compare 1) the colonoscopic and pathology histories     including history of ampullary adenoma in the duodenum over family generations, 2) the use of     chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic     surgical resection of the colon with those that have elected to continue routine colonoscopic     surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary     adenoma and level of dysplasia, etc) which may influence management decisions.   "
41086|NCT02747849|"     The investigators believe in order to strengthen the evidence in support of transcutaneous     foot stimulation in this population the investigators need to move forward with a randomized     comparison study using the TENS device on the hand and foot as a control.   "
41087|NCT02747836|"     This study evaluates the ability of ultrasound to measure the movement of tendons and nerves     within the human carpal tunnel.   "
41222|NCT02746042|"     To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the     treatment of chronic rhinosinusitis (CRS) in adults.   "
41088|NCT02747823|"     This study aims to investigate the bioequivalence of new formulation of bevacizumab called     CBT124 and safety when compared to two already marketed formulations, one approved in US and     other in EU of Avastin(Registered Trademark). Adult healthy male aged 18 to 50 years (both     inclusive) can participate in this trial.      Participants will be randomised (allocated by chance) to either a test formulation or one of     the two marketed formulations of bevacizumab. Drugs will be administered intravenously once     only. The study will compare the safety, tolerability, pharmacokinetics (PK) (the levels of     drug in the blood), pharmacodynamics (PD) (what the drug does to the body) and immunogenicity     (body's immune response) of the 3 drugs. In order to measure this, blood samples will be     collected at various points after treatment has been given.   "
41117|NCT02747433|"     Stroke is the leading cause of long-term disability in older adults in the United States. At     six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke     each year continue to have motor impairments that inhibit functional use of the weaker arm     during daily activities and negatively impact quality of life. Rehabilitation robots provide     clinicians with new treatment options to improve movement and arm function after stroke. The     purpose of this pilot study is to develop and test a therapy called the Active Learning     Program for Stroke (ALPS). We are combining this therapy program with robot-assisted therapy     and a home program for the stroke-affected arm and hand.   "
41089|NCT02747810|"     Background: Previous animal model studies at the University of Pittsburgh have shown a     significant impact on inhibiting bladder over activity and increasing bladder capacity with     neuromodulation techniques, specifically tibial nerve stimulation. This has been translated     into adult clinical trials through the department of urology. Through the use of a     commercially available subcutaneous nerve stimulator placed on the dorsum of the foot,     researchers were able to demonstrate a significant increase in bladder capacity and the delay     of voiding sensation for up to 5 hours after stimulation in eight healthy subjects. This     prompted the clinical trial approved under IRB PRO13020474 which is currently enrolling     patients.      The incidence of night-time overactive bladder leading to nocturnal enuresis (bed wetting) is     very common in the pediatric and teenage population, particularly in patients without daytime     bladder over activity symptoms. When behavioral modification (i.e. refraining from night-time     fluid consumption and bladder irritants, and bed wetting alarms for timed voiding) fails     which it often does there is a paucity of effective and safe treatment options. Medications     can be tried, but generally these are from the tricyclic antidepressant family and carry     significant side effects limiting the use.      Aim: Researchers aim to utilize the same technology currently being studied under IRB     PRO14080250. Electrical stimulation will be applied to the foot via skin surface electrodes     for a minimum of 1 hour before bed for 2 weeks to 5 normal subjects. Normal Subjects will be     asked to complete a questionnaire about any skin irritation or experiences of toe twitching     while wearing the newly designed TENS device, during a return visit with Dr. Stephany. The     primary outcomes of this study are safety and functionality of the New TENS unit   "
41090|NCT02747797|"     Lucitanib is an oral multi kinase inhibitor designed to block the action of certain molecules     called angiogenic factors that may cause tumors to grow. These factors are called vascular     endothelial growth factor (VEGF), platelet derived growth factor receptor (PDGFR) and     fibroblast growth factor (FGF). Lucitanib is experimental and not approved by the FDA for the     treatment of cancer.      The purpose of this study is to look at the effects of lucitanib in cancer patients whose     cancers harbor aberrations in FGFR, VEGFR, PDGFR or other markers predicted to be sensitive     to lucitanib. This study will also look for biomarkers in samples of blood and tumor tissue     to identify patients most likely to respond to lucitanib. Biomarkers are substances such as     genetic material (DNA and RNA) and proteins found in blood and tumor tissue that might show     if a cancer patient will respond or not respond to a drug.   "
41091|NCT02747784|"     The purpose of this open, monocentric randomized, parallel-group, controlled trial is to     compare two different computer-based cognitive training programs regarding the efficacy to     prevent the 3-months incidence of postoperative cognitive dysfunction in female patients     after elective urogynecological or breast cancer surgery.   "
41092|NCT02747771|"     This study aims at evaluating the effectiveness of group-based cognitive behavioral therapy     for trichotillomania at three clinical sites in Norway.   "
41093|NCT02747758|"     This study evaluates the effect of additional transcranial direct stimulation (tDCS) on pain     in patients with chronic neuropathic pain undergoing treatment with regional     anaesthesiological techniques.   "
41094|NCT02747745|"     The growing number of persons with dementia (PWDs) calls for policy changes and service     innovation. Recent case management (CM) research is recognized by its positive impacts on     family caregivers (FCGs) of PWDs. However, research gaps are identified, including the     paucity of theoretical based CM practice and a lack of mediator effects. Therefore, the     original purpose of this five-year project was to implement a theoretical-based randomized     controlled CM intervention for FCGs of early to moderate PWDs at home based on a stress model     and tailor to needs prioritized by FCGs. This project was funded by the Minister of     Scientific and Technology for the first two years and accomplished the first two aims: 1.     First year: to develop and test the psychometric properties of related instruments and     protocol (cross-sectional study); 2. Second year: to conduct a feasibility test for the CM     intervention (a pilot RCT). The purpose of the current project is to achieve aim 3 (three     years): to implement a 4-month CM intervention (the main RCT). In total, there will be 2 home     visits, 2 phone calls to the dyads, and receiving telephone calls from the FCGs during the     working hours. Investigator will collect 4-time point data at T0 for base line data, T1     (after the recruitment, 4 th month, the first follow up), T2 (after the recruitment, 6th     month, the second follow up) and T3 (after the recruitment,12 th month). Investigator will     recruit 76 dyads in three years (38 dyads for each group)(n = 152 in total). The primary     outcomes are FCG QoL and PWD behavioral problems, while the secondary outcome is the     percentages of PWD status (i.g. nursing home admission) and the frequency of PWD acute     hospitalization. Investigator will also test of mediator effect of FCG self efficacy using     statistical analysis method such as Hierarchical Linear Modeling (HLM).   "
41177|NCT02746653|"     The use of the TroClose1200™ will be done in at least one 12mm planned access port per the     TroClose1200™ Instruction for Use. The procedure will be performed routinely. Adverse Events     and device malfunctions, if any, will be recorded. Subjects will be hospitalized in     accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days),     at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which     healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit,     the hernia signs will be evaluated by ultrasound.   "
41095|NCT02747732|"     This is a phase 2 study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (ibrutinib), in     combination with bendamustine and rituximab (BR) in subjects with previously treated     aggressive B cell non Hodgkin lymphoma (aB-NHL) including any subtype of diffuse large B cell     lymphoma (DLBCL) primary mediastinal B cell lymphoma (PMBCL), double and triple hit DLBCL,     transformed indolent lymphoma, unclassifiable aggressive B cell lymphoma between DLBCL and     Burkitt lymphoma. Patients with CNS involvement (primary or secondary) will be excluded.     Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent,     orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase     currently FDA approved for the treatment of relapsed Mantle cell lymphoma (MCL), Chronic     Lymphocytic Leukemia (CLL) and waldenstrom Macroglobulinemia (WM).It is under constant     investigation for the treatment of other B-cell malignancies. The initial approval of     ibrutinib was received on 13 November 2013 by the United States Food and Drug Administration     for the treatment of adult patients with MCL who have received at least 1 prior therapy.     Ibrutinib has not been approved for marketing for the treatment of aggressive B cell lymphoma     although Phase I trial in this setting has already been published. In Israel ibrutinib is     registered for the treatment of MCL and CLL.   "
41096|NCT02747719|"     Both light and exercise are effective countermeasures for space and ground-based crews for     circadian phase resetting and alertness levels. The investigators propose to test the     combined effects of these two countermeasures to determine whether adding exercise to light     stimuli will further improve circadian phase resetting and alertness.   "
41097|NCT02747706|"     There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days     of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization     visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the     community) can be effective in reducing hospitalizations for asthmatic children.      This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to     reduce asthma-related pediatric hospitalizations and emergency department visits.   "
41099|NCT02747667|"     Late in-the-bag intraocular lens (IOL) dislocation occurs up to 30 years after cataract     surgery and the prevalence ranges from 0.1% to 3.0%. Before the introduction of the     continuous curvilinear capsulorhexis, late dislocation was very uncommon but since then     several case reports and case series were observed. In-the-bag IOL dislocation is a     well-known postoperative complication, especially in eyes with weak zonules as seen in     pseudoexfoliation syndrome (PXF), high axial myopia, uveitis and retinitis pigmentosa (RP).      In this retrospective study, medical records of all patients with IOL related problems after     implantation of one hydrophilic acrylic single-piece lens at the Department of Ophthalmology     Graz, Medical University Graz, Styria, Austria are reviewed. Characteristics and predisposing     factors for late in-the-bag, out-of-the-bag IOL dislocations, and haptic complications will     be investigated and compared amongst each other or control patients. Incidence rates for each     IOL complication will be calculated. For in-the-bag dislocations odds ratios for each     predisposing factor will be calculated.   "
41100|NCT02747654|"     Isoniazid (INH) is an essential component of first-line anti-tuberculosis (TB) treatment.     However, treatment with INH is complicated by polymorphisms in the expression of the enzyme     system primarily responsible for its elimination, N-acetyltransferase 2 (NAT2), and its     associated hepatotoxicity. The objective of this study was to develop an individualized INH     dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot     study.   "
41101|NCT02747641|"     The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the     treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary     endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale     (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by     patient filled Vulvovaginal Atrophy.   "
41102|NCT02747628|"     Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective     laparoscopic cholecystectomy under general anesthesia were included in this randomized     controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group     patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h).     Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP,     postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis,     respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12     hours postoperatively. Postoperative Patient`s and Surgeons` satisfaction, Intraoperative     bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.   "
41103|NCT02747615|"     Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II     were included in this randomized study who were divided into the study group of 30 patients     who had been transfused autologous blood and the control group of 30 patients who had been     transfused only allogeneic blood. Parenteral iron preparation was given to all patients of     the study group after each donation. Intraoperatively all patients of the study group     received 2 grams of intravenous tranexamic acid. This study was conducted through the     laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for     both groups in the pre-operative and the post-operative period and the assessment of the     amount of transfused blood units in both groups.   "
41104|NCT02747602|"     To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after     administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard     breakfast.      To evaluate the effect of a high fat diet on serum ketone body levels after administration of     CT oil with a high fat breakfast versus a standard breakfast.   "
41105|NCT02747589|"     In this study, the investigators intend to evaluate the use of a commercially available     neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. The NeuroPace     RNS System has a proven record of safety and reliability was approved by the FDA in November     2013. The RNS System is indicated for use in patients with epilepsy and includes a skull     implanted neurostimulator. No modification to the RNS System is required for this study. This     study will use this device to better understand the effect of stimulation on the visual parts     of the brain.      The main purposes of this study are to confirm the desired location to implant a device in     the visual cortex, determine the amount of energy needed to elicit vision, and assess the     nature of the vision that is produced. This information is important to have early in the     process of designing a visual cortical prosthesis that could eventually be used for     commercial use.   "
41106|NCT02747576|"     Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social     deficits, including specific skills such as facial affect recognition which is the ability to     recognize the emotional expressions of another person. Because the underlying mechanisms of     these deficits are poorly understood, the investigators propose to examine social-cognitive     skills (i.e. facial affect recognition) and indices of brain integrity, including an     established core neural network of face perception in MB survivors and healthy controls. By     comparing these outcomes between survivors of MB and healthy controls, investigators seek to     identify the areas of the brain that help individuals recognize emotions.      Primary Objective:        -  To evaluate social cognition in adolescent and young adult survivors of pediatric          medulloblastoma.      Secondary Objective:        -  To examine indices of brain integrity and function and their association with facial          affect recognition in survivors of pediatric medulloblastoma.   "
41107|NCT02747563|"     Patients with know prostate cancer (PCa) under active surveillance and aged matched controls     without evidence of PCa will have a PSA blood test prior to and following standardized     digital rectal examination   "
41108|NCT02747550|"     The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous     two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.   "
41118|NCT02747420|"     This is a prospective, single center, double-blind, randomized, controlled trial comparing     the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder     Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.   "
41119|NCT02747407|"     This research trial studies qualitative, qualitative, and functional studies over the first     year in measuring immune system response in patients with brain tumors. Measuring the number     of immune cells, whether these immune cells work correctly, and response to 2 vaccines at     several times during the first year of treatment may help find out how active the immune     system responds to fight infection and cancer.   "
41109|NCT02747537|"     This study proposes to treat patients with the combination of sorafenib and irinotecan.     Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors possess     a non-synonymous mutation in Raf, PDGFR, VEGFR, Flt-3, KIT, JAK, STAT, RAS, MEK, or ERK will     be eligible for the study. Very few phase 2 clinical trials have been performed in pediatrics     using targeted agents in combination with conventional chemotherapy agents. Furthermore,     since some combinations such as the combination of this study (sorafenib and irinotecan) have     shown additive/synergistic effects in preclinical studies, therapy selecting for those     patients who possess mutations targeted by the TKI of the study, may unveil activity that has     not been previously observed. Thus, the investigators hope to determine whether the addition     of additive/synergistic chemotherapy will increase efficacy of the targeted agent and/or     increase tumor susceptibility to the targeted agent, resulting in increased anti-tumor     activity.   "
41110|NCT02747524|"     This study applied a matched cluster, controlled design, using community cluster as the unit     of randomization. Communities were first matched during the formative research phase and     randomized into treatment (Vita Mamba + deworming) or control (deworming) groups, using a     simple experimental 1:1 design. The principal investigator generated the random allocation     sequence and assigned the cluster to groups. Children were followed longitudinally for Hb     concentration and anthropometric measures were taken at baseline (November 2014) and endline     (June 2015). Parents were surveyed at baseline for household-level socioeconomic and     demographic information; environmental conditions including water, hygiene, and sanitation;     and child diet and morbidities.      All children in the intervention schools received the Vita Mamba once per school day from     November 2014 to June 2015, for approximately 26 weeks. Children in both groups received     Albendazole at baseline in November 2014. Compliance was monitored by teachers and tracked by     collection of empty packages. Lessons learned from another school feeding trial by the study     team were applied to increase compliance such as opening the packages for the children     immediately prior to consumption to discourage selling or sharing later with family members.     Vita Mamba was developed for the urban school trial by the research team with representatives     from Edesia (a US-based nonprofit manufacturer of ready-to-use foods with expertise in     research and development) and Nutriset (the parent company in the PlumpyField network). Meds     & Food for Kids, a nonprofit manufacturer of ready-to-use foods in Haiti using locally     produced peanuts, produced the Vita Mamba for this trial. Vita Mamba (50 g) contains 260 kcal     and meets >75% of the Recommended Dietary Allowance (RDA) for critical micronutrients (S1     Table).   "
41111|NCT02747511|"     Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain     scores in patients who present to the emergency department (ED) with a complaint of headache.     A total of 150 patients age 13-55 presenting to the emergency department with headache will     be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and     side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by     telephone at 24 hours.   "
41112|NCT02747498|"     The purpose of this study is to compare the clinical outcomes depending on catheter ablation     strategy for repeat ablation procedure among the patients with recurred atrial fibrillation     after de novo catheter ablation. After randomization, the investigators will conduct     circumferential pulmonary vein isolation alone in a group, and additional posterior box     isolation and anterior linear ablation in the other group. Non-pulmonary vein foci ablation     will be done in all patients. The investigators will compare clinical recurrence rate,     complication rate, and procedure time, etc.   "
41113|NCT02747485|"     New strategies are needed to early detect myocardial involvement in these diseases.     Histological studies showed that diffuse fibrosis and cardiomyocyte hypertrophy precede the     LV remodelling (dilatation) observed by cardiac imaging. Quantification of LV diffuse     myocardial fibrosis using magnetic resonance imaging (MRI) could reach this goal. Recently,     contrast enhanced cardiac MRI has been used to measure the extracellular volume fraction     (ECV) of the myocardium, and it has been able to detect diffuse myocardial fibrosis. In     diseases in which increased collagen deposition enlarges the extra-cellular space, the ECV     can act as a fibrosis index. ECV is correlated with the amount of fibrosis measured by     histology. Left ventricular overloads induced by regurgitant VHD result in cardiomyocyte     hypertrophy and diffuse fibrosis. Other methods can be used to estimate the degree of     myocardial fibrosis such as the serum level of galectine-3 or ST2. Moreover, although the     pathophysiological mechanisms leading to the occurrence of myocardial fibrosis differ in     patients with various cardiac diseases, the cellular effectors of fibrotic remodelling are     common and involve similar signalling pathways. At the cellular level, key progression of     ventricular hypertrophy is associated with increased cardiomyocytes apoptosis and fibrosis,     suggesting that these two processes are responsible for the transition.      To our knowledge, no study has analysed the impact of the rate of myocardial diffuse     fibrosis, non-invasively estimated by ECV, in the risk of LV dysfunction during MR and AR,     especially after surgery. The measurement of ECV could become an important tool for risk     stratification in left-sided regurgitant VHD. Thus, it would provide an early marker of LV     myocardial involvement before the occurrence of global remodeling, might help physicians in     surgical decision, and would improve prognosis. This is an innovative original project     because it uses modern imaging modalities to answer to a crucial question. The clinical     implications would be important because this work would modify the international surgical     indications of MR and AR in order to finally improve the prognosis of patients with this     frequent heart disease. Moreover, investigators will analyze the genetic factors that can     influence the myocardial reaction resulting from these regurgitations, which will improve the     quality of this work and offer new future perspectives.      Investigators hypothesize that the ECV measurement could be used as an early predictor of LV     dysfunction in the left-sided valve regurgitations.   "
41115|NCT02747459|"     The purpose of Sensory Supported Swimming is to provide a sustainable, low cost recreational     swim program for children with ASD. A secondary purpose is to train general recreation     providers and swim instructors to meet the unique needs of children. Specific aims include     both program development and research aims as described below.      Specific Aims:      1. Provide more opportunities for families of children with ASD to access a recreational swim     program at low cost. (program development) 2. Increase the capacity of swim instructors and     general recreation providers working with children with ASD. (Research) 3. Increase physical     activity for children with ASD in a way that is a good match for their individual sensory     needs. (Research) 4. Increase safety among children with ASD in and around the water so they     and their families can swim safely. (Research) 5. Transition swimmers with ASD from a     learn-to-swim program to an inclusive swim team. (Program Development) Hypotheses        1. The Sensory Supported Swim Program will increase physical activity of children with ASD.        2. The Sensory Supported Swim Program will increase safety of children with ASD in and          around the water.        3. The Sensory Supported Swim Program will increase the capacity of general recreation          providers and swim instructors to serve children with ASD.   "
41116|NCT02747446|"     The metabolic effects of 7-day weight-maintenance diets containing 10% total energy as acacia     honey or a fructose:glucose mixture will be assessed in a group of healthy male volunteers.     Primary outcome is plasma total triglyceride concentrations after ingestion of standardized     breakfast and lunch containing 25% energy as honey or fructose:glucose mixture; secondary     outcome is glucose tolerance and suppression of endogenous glucose production after ingestion     of 75 g glucose. Results obtained with 10% honey and 10% fructose: glucose mixture diets will     be compared to results obtained with a weight-maintenance, isocaloric diet in which starch is     substituted for honey or fructose:glucose mixture   "
41120|NCT02747394|"     Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits     that interfere with learning, socialization and emotion regulation. Extensive research     focused on the animal models of FXS show that targeted pharmacological agents can normalize     synaptic connectivity and reverse cognitive and behavioral deficits. This translational work     has led to multiple national and international controlled trials in humans with FXS now     underway. However, in contrast to the heavy focus on medication treatments, there have been     no controlled trials to empirically-validate cognitive or behavioral interventions for FXS.     The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the     efficacy of Cogmed, a cognitive training program proven to enhance working memory and     executive/frontal function in a variety of clinical populations. Demonstration of effective     Cogmed training for FXS would represent a major advance in the field, one that may also     generalize to other forms of intellectual disability. Furthermore, it is critical to     determine whether the targeted pharmacological treatments can accelerate learning and     cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for     testing hypotheses focused on combined efficacy of medication and cognitive training.   "
41121|NCT02747381|"     This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on     the the pulmonary function of adult asthmatic Egyptian patients   "
41122|NCT02747368|"     The aim is to study the use of Ocusweep system especially in driving health evaluation and     compare the results produced by Ocusweep system to those of conventional devices. The main     focus is in patients suffering from wet age-related macular degeneration. The study aims to     find out how frequently these patients do not meet the European Union health criteria of safe     driving and how Ocusweep finds these patients from a population of patients being treated in     a busy medical retina clinic. The tests of Ocusweep system are compared against conventional     visual field tests, contrast sensitivity tests, visual acuity tests and tests showing     anatomical changes related to wet age-related macular degeneration (optical coherence     tomography, fundus photography and fluorescein or indocyanine green angiography).   "
41123|NCT02747355|"     In adrenal tumors, the investigators will examine if there is any correlation between WIESS     criteria, prognosis of the tumor, and the different labeling index of the following     proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN,     SEMAPHORIN-3A.   "
41124|NCT02747342|"     This is a multicenter, dose-escalation phase 1 trial to evaluate the safety and tolerability     of SHR3680 given orally to subjects with metastatic castration-resistant prostate cancer     (mCRPC) as monotherapy.   "
41125|NCT02747329|"     The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience     V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting     in relatively high bleeding risk patients with coronary artery disease using OCT.   "
41126|NCT02747316|"     Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk     for iron deficiency. Studies in our laboratory have shown that this is mainly the result of     reduced dietary iron absorption because of increased hepcidin concentrations. During     pregnancy, women have a large increase in iron needs because of the expansion of maternal     blood volume and fetal needs. Iron deficiency anemia in infancy can impair cognitive     development. Whether maternal adiposity impairs absorption and transfer of iron to the fetus,     and thereby increases risk of iron deficiency in the mother and the infant is unclear.   "
41127|NCT02747303|"     The objective is to to compare 2 mm vs 0 mm PTV margins with respect to local PFS and risk of     radionecrosis when treating intact brain metastases with LINAC-based frameless SRS   "
41128|NCT02747290|"     This is an open-label positron emission tomography/computed tomography (PET/CT) study to     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in     prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD     will be injected intravenously. Visual and semiquantitative method will be used to assess the     PET/CT images.   "
41129|NCT02747277|"     This observational study aims at finding out if individual with autoimmunity exhibit     increased numbers of B cells that express two types (instead of one type) of antibodies, and     if B cells of individuals genetically susceptible to autoimmunity display defects in the     biological process of tolerance, which removes B cells that participate in autoimmunity.   "
41491|NCT02742532|"     The purpose of this study is to determine whether oxytocin will decrease craving to use     alcohol and stress reactivity following exposure to laboratory-induced stress among Active     Duty Service Members with a dual diagnosis of alcohol use disorder and post-traumatic     anxiety.   "
41130|NCT02747264|"     The purpose of the Electronic Patient Self-Reporting of Adverse-events: Patient Information     and aDvice (eRAPID) programme is to determine whether eRAPID (an online system for patients     to self-report symptoms and side effects) can enhance patient care and improve the safe     delivery of cancer treatments. The investigators hypothesise that patient symptoms will be     detected earlier with more timely admissions and a reduction in overall hospital contacts. It     is predicted that staff will save time recording symptoms and side effects and will be able     to focus attention during clinical contacts on more severe side effects. eRAPID is a     cost-effective approach to supporting patient self-management and reducing hospital/General     Practitioner (GP)/community contacts.      The majority of the research will be run with systemic patients. This particular part of the     research is a feasibility study in radiotherapy (RT) patients to test the platform in a     different patient group.   "
41131|NCT02747251|"     This study evaluates the addition of a high dose of simple home-based elastic band     strengthening exercises to usual care in patients with subacromial impingement syndrome. Half     of the participants receive instructions in simple home-based elastic band strengthening     exercises in addition to usual care, while the other half receive usual care.   "
41132|NCT02747238|"     The investigators believe that ultrasound guided CSE technique will help junior resident     rotating for the first time on the labor and delivery floor to place more accurately the     epidural needle in the midline position as compared to placing the epidural needle via     palpation of anatomical landmarks. This will result in increased ability to place the spinal     component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline     placement of the epidural catheter, and increase the likelihood of adequate symmetrical labor     analgesia/anesthesia.   "
41207|NCT02746250|"     The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent     Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare     the results with healthy individuals.   "
41133|NCT02747225|"     Previously published studies have indicated that there exist difference in electrical     properties (EPs), i.e., the conductivity and relative permittivity, between malignant and     adjacent normal tissue, which will be useful in the early detection of cancers. However the     EP information mainly based on ex vivo measurement of cancer tissues, and few data in vivo     were published. The purpose of this study is to in vivo measure the electrical properties of     the malignant tissues.   "
41134|NCT02747212|"     Previously published studies have indicated that there exist difference in electrical     properties (EPs), i.e., the conductivity and relative permittivity, between malignant and     adjacent normal tissue, which will be useful in the early detection of cancers. While the EP     informations of cancer tissues are not sufficient enough. The purpose of this study is to     measure the electrical properties of the excised malignant tissues obtained from cancer     surgeries.   "
41135|NCT02747199|"     This is a prospective, non-randomized, single center clinical trial to assess neointimal     coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of     12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using     OCT and CAS   "
41136|NCT02747186|"     Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal     dosages, and a lower dosage of the buffered drug might be used with an effect equal to higher     dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published     data exist comparing buffered local anesthetics at lower drug concentrations to current     dosages commonly used in dental and oral surgical procedures   "
41137|NCT02747173|"     Prospective observational study to assess bone predictive biomarkers for TKI response in RCC     patients with bone metastasis and HRQoL with TKI in these patients as well as the sensitivity     and specificity of whole body magnetic resonance versus bone scintigraphy and versus CT in     the assessment of metastatic lesions at bone level and at other sites.   "
41138|NCT02747160|"     The purpose of this study is to examine the feasibility and acceptability of and patient     adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety     in older adults (65 years and older) with cancer and their primary informal caregiver. This     study will also examine whether the intervention has a clinically significant impact on     patient anxiety (primary outcome) and depression, distress, and quality of life (secondary     outcomes).   "
41139|NCT02747147|"     Prospective, randomized, single-center study to evaluate the ability of the device to collect     good quality blood samples from patients with peripheral IV access over the length of their     stay.   "
41140|NCT02747134|"     In the present study researchers aim to investigate the effectiveness of an intervention     combining emotion regulation and mindfulness skills in a single 10-week program. A total of     75 individuals with major depressive disorder (MDD) diagnosis in complete or partial     remission participated in this randomized controlled trial (RCT) comparing an intervention     including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program.     After treatment, participants were followed for a 1-year period. Researchers results indicate     that ER+M was not more effective than the treatment used with the control group in preventing     depression relapse. Participants allocated to the ER+M group showed a significant decrease on     global psychiatric symptoms, whereas those in the control group did not. Further studies are     needed in order to better determine the combined effects of mindfulness and behavioral     activation.   "
41141|NCT02747121|"     External inspections are widely used as means to improve the quality of care. Despite their     widespread use, there is limited knowledge about whether and how they affect the quality of     care. This study uses inspection with detection and treatment of sepsis in hospitals as a     case to evaluate the effect of inspections on the quality of care and to explore how     inspections affect the hospitals.   "
41178|NCT02746640|"     In case of a cardiac arrest it is very important to quickly provide high quality     cardiopulmonary resuscitation (CPR). For reasons of patient safety the investigators want to     assess the frequency, the quality and the outcome of cardiopulmonary resuscitations in the     Inselspital Bern.   "
41233|NCT02745899|"     the investigators hypothesis is that milk consumption, either in the acute phase and through     prolonged exposure, does not cause or increase respiratory symptoms or airway inflammation.     the investigators aim to objectively prove this by examining respiratory symptoms and signs     and objectively measuring parameters of airway inflammation and hyper responsiveness after     consumption of cow milk or soy milk substitute.   "
41142|NCT02747108|"     This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and     brief counseling about screening test results on weight and key health behaviors among     Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of     two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test     Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood     sugar levels. Participants will receive brief counseling about the results from their primary     care provider or someone authorized to speak on their behalf. Participants randomly selected     for the Brochure Group will review a handout from the VA National Center for Health Promotion     and Disease Prevention (NCP) on recommended screening tests and immunizations. All     participants will be asked to complete a survey prior to study group assignment, immediately     after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.   "
41143|NCT02747095|"     The CT examination on IQon Spectral CT would be a standard of care CT performed as per the     clinical indication. The conventional CT images generated by the scanner will be used for     clinical purposes as routinely practiced. And therefore, the primary study aim is to assess     the impact of IQon Spectral CT scanner and applications on the clinical workflow of the site     as well as the diagnostic confidence levels of the physicians reading the CT cases.      In addition to the aim mentioned above, the investigators would like to develop     recommendations for the clinical application of the spectral images in routine use. Such     recommendations could include optimization of scanning protocols, optimization of     reconstruction parameters; evaluate the utility of iodine maps and other supported materials.   "
41144|NCT02747082|"     The aim of this randomized clinical trial is to compare the antibacterial effects of 1%     sodium hypochlorite (NaOCl) and 2% chlorhexidine gluconate (CHX) during retreatment of teeth     with apical periodontitis (AP).   "
41145|NCT02747069|"     This study will evaluate the accuracy of both an electronic stethoscope and electrocardiogram     (ECG) to evaluate heart rate in neonatal patients in the delivery suite.      The initial phase of this study will assess the electronic stethoscope use on stable neonates     on the neonatal care prior to use in the delivery room.   "
41208|NCT02746237|"     Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on     single and multiple ascending doses of KAR5585 in healthy adults.   "
41657|NCT02740361|"     This is an international, multicenter, randomized controlled trial of an internet-based CBT     intervention for depression (Deprexis) conducted in five MS centers in the US and Germany.     The trial consists of a three-arm primary trial phase and an extension phase targeted at     maintenance.   "
41146|NCT02747056|"     The research aims at clarifying the impact of autism on personal identity in adulthood. Two     studies will be made in order to compare adults with autistic spectrum disorders without     intellectual deficiency and controls. In the first study (Study A), the investigators will     ask subjects to tell autobiographical memories and to specify their characteristics by     answering focused questions. In the second study (Study B), the investigators will ask     subjects to say the self statements which define them. Then, subjects will have to tell and     to specify the characteristics of the autobiographical memories linked to these self     statements.   "
41148|NCT02747030|"     In central retinal vein occlusion (CRVO) a blood clot blocks the venous outflow of the entire     retinal circulation. This leads to retinal and vitreous hemorrhages, retinal edema and     neovascularization. The development of a microneedle and surgical stabilizer made it possible     to perform a prolonged (10 minutes) retinal vein cannulation with infusion of Ocriplasmin.     Ocriplasmin has the advantage over tissue Plasminogen Activator (tPA) that it already is an     active enzyme and a strong fibrinolyticum. This study aims to investigate the feasibility and     safety of local intravenous Ocriplasmin for CRVO.   "
41149|NCT02747017|"     The primary objective of this observational study is to estimate the 90-day response rates to     treatment for a first episode of C. difficile infections (CDI) in adult transplant     recipients.   "
41150|NCT02747004|"     The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus     tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive     (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.   "
41151|NCT02746991|"     This is a phase 3, multi-center, randomized, masked, controlled study to evaluate the safety     and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the     management of subjects with chronic non-infectious uveitis affecting the posterior segment of     the eye. Patients will be randomized to receive either a sham injection or the FAI insert and     will be observed for three years following treatment.   "
41152|NCT02746978|"     Shepherd Center is bringing a more patient-centered focus to educational, peer-support, and     technology resources offered to patients with spinal cord injury and their families and is     evaluating these changes.      Approximately 740 patients have provided information about healthcare utilization following     inpatient rehabilitation. This information will help Shepherd Center staff follow utilization     trends and plan programs targeted at the high-use areas.   "
41153|NCT02746965|"     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and     its safety among schizophrenia patients. Half of the participants will be randomized to MST     group, while the other half will be randomized to receive electroconvulsive therapy (ECT).   "
41154|NCT02746952|"     The purpose of this study is to evaluate the safety and tolerability of ascending doses of     UCART19 in patients with relapsed / refractory (R/R) B-cell acute lymphoblastic leukaemia     (B-ALL) and to determine the maximum tolerated dose (MTD).   "
41155|NCT02746939|"     The study is designed to examine whether curriculum, designed in partnership with teachers at     Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able     to influence the behavior and health literacy of students. This information will be collected     in surveys before and after the students are given the curriculum during the school day.   "
41156|NCT02746926|"     3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for     each test and every subject will test all 3 different formulations. After swallowing     tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14     days, subjects will take a different formulation of tafamidis and tafamidis blood     concentrations will be measured periodically for 8 days. After another 14 days, the last     formulation will be tested in the same way.   "
41158|NCT02746900|"     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many     countries, including the United States. In singleton gestations a short cervical length (CL)     on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.      Different strategies have been adopted for prevention of SPTB. Growing interest has focused     on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use,     does not require anesthesia, can be used in an outpatient clinic setting, and it is easily     removed when necessary. However, a recent systematic review and meta-analysis of randomized     clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of     the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal     outcome. The evidence supports the use of vaginal progesterone in singleton pregnancies with     short cervix, while cervical cerclage seems to be beneficial only in the subgroup of women     with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior     SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized     studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical     cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7     However, even if the statistical significance were not reached, they found a reduction in     SPTB <35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs 31.2%;     relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in singletons     without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15).      Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in     prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without     prior SPTB.   "
41159|NCT02746887|"     This is a follow-up cohort study of 8 years old children born preterm at Seoul National     University Children's Hospital in Korea from 2008-2009.      The children will visit outpatient clinics for examinations regarding growth, obesity and     other risk factors related to metabolic syndrome.      The purpose of this study is to compare growth and risk factors of metabolic syndrome among     children born preterm and children born healthy term at school age   "
47352|NCT02665806|"     This study is designed to compare ciclesonide nasal spray once daily with fluticasone     propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal     polyposis, in order to relieve symptoms of these patients.   "
41160|NCT02746874|"     More than 300,000 total knee joint replacement surgeries are performed per year in the United     States and safe, effective management of post-operative pain in these patients, often     elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be     challenging and often require a multidisciplinary, multimodal approach. Opiates have been a     mainstay of treatment in the post-operative period with varying degrees of success and     complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled     pain inhibits early mobilization and hinders post-operative physical therapy.      A new paradigm for treating post-operative pain following total knee replacement may be the     use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the     knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the     anterior capsule and thereby decrease post-operative pain. There are several publications     that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis     however the use of RFA in the preoperative management of pain in patients undergoing total     knee joint replacement has not been investigated.      The aim of this study is to determine if patients undergoing unilateral total knee     replacement obtain any post-operative pain relieving benefits from C-RFA of the articular     sensory nerve supply when performed prior to surgery, as compared to sham controls who     receive only local anesthetic injections of these same nerves without the benefit of ablation     treatment.   "
41161|NCT02746861|"     The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African     American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients     with poorly-controlled diabetes.   "
41162|NCT02746848|"     For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson     syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal     surgery and others, it is important that short time treatment with minimal side effect should     be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract     Eye Drop (AMEED) as a natural substance for acceleration of corneal healing   "
41163|NCT02746835|"     Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary     falls prevention program. This program consisted on an adapted exercise program.      Two sessions per week were performed, during 6 weeks supervised by a physiotherapist.      At the end of this program, measures of physical condition and of self-efficacy were repeated     to determine its related-effect.   "
41164|NCT02746822|"     Thirty patients with acute ST-elevation myocardial infarction treated with primary PCI and     aspiration of thrombus material from the infarct related coronary artery will be included.     Both cellular and non cellular content of the thrombus will be examined with morphological     and immunohistochemical methods and related to time from onset of symptoms to PCI, as well as     to the degree of myocardial necrosis. Furthermore, mRNA expression of selected signal     molecules will be performed. In addition, peripheral venous blood samples will be drawn and     analyzed for signalling molecules and corresponding mRNA expression in circulating     leukocytes.   "
41165|NCT02746809|"     The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R     transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic     aortic stenosis who are considered at high or extreme risk for surgical aortic valve     replacement.   "
41166|NCT02746796|"     The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in     unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)     not previously treated with the first-line therapy. Part 1 is intended to evaluate the     tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur /     gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin).     In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX     therapy), taking into account the condition of each subject. Part 2 is planned to evaluate     the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.   "
41201|NCT02746341|"     Evaluate the clinical progression in patients with MPS IIIA who are untreated with any     investigational product and to obtain standardized assessments: neurocognitive, behavioral,     sleep-wake habits and effect of MPS IIIA on the quality of life of patients and their     families.   "
41202|NCT02746328|"     This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024     9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+     breast cancer.   "
41203|NCT02746315|"     This trial is conducted in China. The aim of this trial is to assess the safety and     tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects   "
41167|NCT02746783|"     This study will assess the effect of a different dose of the seasonal flu vaccine 2013-2014     on the immune response to improve the investigators understanding of cellular and humoral     immune responses induced. The scope of this study is to determine the profile of cellular     activation and antibody production in the ageing immune system following flu immunization.      This study will enroll 100 male or female subjects ≥65 year old. These persons will be deemed     to be  at risk  in case of influenza infection and should be vaccinated according to Swiss     Federal Office of Public Health. A medical doctor from the CHUV will inform the patients     about the present study and ask them whether they would be willing to participate in the     study.      All subjects will be distributed between the two groups according to a computer-generated     randomization sequence. The randomization will be done in blocks to ensure balance across     groups. The participants and site staff will not be blinded due to the different     administration assignments.      Group 1 subjects will receive a single dose and group 2 subjects a double dose of MUTAGRIP®     manufactured by Sanofi Pasteur containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2);     B/Massachusetts/2/2012. Vaccine immunogenicity and safety will be assessed 1, 2, 4 and 24     weeks after vaccination.      Study duration per volunteer is 6 months after vaccination.   "
41168|NCT02746770|"     Spanish population with unilateral peripheral vestibular disorders.   "
41169|NCT02746757|"     The study was designed to investigate whether glucagon like peptide-1 is a mediator of     protection of endothelial function induced by remote ischemic conditioning in     ischemia-reperfusion   "
41170|NCT02746744|"     A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early     Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.   "
41171|NCT02746731|"     The purpose of this study is to determine whether a combined cardiorespiratory and     strengthening training prior to colorectal surgery decreases the rate of surgery-related     complications.   "
41259|NCT02745561|"     Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular     endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and     safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in     esophageal cancer patients.   "
47380|NCT02665442|"     This Study is designed to determine the outcome and effect of implementation of Esophageal     Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation     catheter ablation procedure.   "
41172|NCT02746718|"     A breach of respiratory function may be one of the elements more or less early or predominant     clinical picture of neuromuscular diseases. It is considered that the obstructive syndromes     represent 64% and restrictive or mixed syndromes 36% of chronic respiratory insufficiency,     approximately 7% due to a neuromuscular disease. The frequency and type of impairment are     dependent on the underlying pathology.      The neuromuscular restrictive respiratory failure (IRR) remains partially unknown     pulmonologists, especially because the signs of muscle weakness are sometimes difficult to     detect. However, respiratory diseases are a major concern in neuromuscular diseases because     they can have an impact both on sleep (not sleep, ...) on the daily activities     (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients.     Moreover, they represent a significant morbidity and mortality factor. Chest tightness may in     some cases reveal the disease and thus constitute the chief complaint of a patient with a     neuromuscular disease. In late-onset Pompe disease, lung disease is the predominant clinical     symptoms in about 30% of patients.      An algorithm was developed to guide practitioners and help them in their diagnostic approach     to the cause of the IRR (diagnostic algorithm ATS / ERS 2005). However, this algorithm does     not allow precise identification of the neuromuscular causes.      At the patient level, this can have an impact by extending the time before placing a     diagnosis. In Pompe disease, the average time to diagnosis reached 7.9 years. However, there     are for this disease a simple and rapid diagnostic test. Therefore, a greater awareness of     practitioners with regard to the particular Pompe disease and neuromuscular diseases in     general may be beneficial to patients.      This study aims to:      i) awareness pulmonologists to the possibility of neuromuscular an IRR.      ii) characterize the frequency of neuromuscular origin of IRR in a broad population of     patients with concomitant signs muscle weakness.      iii) reduce the time to diagnosis by directing patients to neuromuscular reference center     early.   "
41173|NCT02746705|"     This study will test the tolerability and preliminary efficacy of transcranial direct current     stimulation (tDCS) combined with a cognitive training program, remotely-delivered using a     telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will evaluate the     efficacy of tDCS to evaluate two of the most debilitating symptoms of MS: cognitive     impairment and fatigue.   "
41174|NCT02746692|"     Sports medical experts recommend considerable amounts of regular physical activity in order     to improve strength, motor control, endurance and flexibility. However, only a small share of     the population is able to meets the corresponding international guidelines. One reason for     this is supposed to consist in private scheduling problems and the high time expenditure.     Against this background, high-intensity intermittent training methods with short durations     have become popular.      The present study aims to evaluate the effectivity of a high -intensity functional circuit     training (the FIT15 program) in improving body function.      Thirty healthy individuals will be included in the randomized, controlled two-armed parallel     group trial. In the intervention group, the participants will perform the FIT15 program, a     group-based high-intensity circuit training based on functional movement patterns (e.g.     squats, push-ups, burpees, jumps, rope-skipping). The training will be carried out three     times a week, each 15 minutes for a total of six weeks. In the control group, the     participants will exercise three times a week (in total for six weeks) at moderate intensity     on an ergometer according to the cardiopulmonary exercise guidelines of the American College     of Sports Medicine. Outcomes assess prior and following the six-week training period     encompass body fat and muscle mass (bio impedance analysis), aerobic exercise capacity     (spirometric exercise testing including lactate analysis), postural control (force plate),     maximum strength of the leg extensors and shoulder muscles (1 repetition maximum) and     psychometric variables (e.g. physical activity readiness questionnaire).   "
41175|NCT02746679|"     The purpose of this study is to determine whether mindfulness based stress reduction are     effective on improve anxiety, depression and quality of life in women with intrauterine     adhesion   "
41176|NCT02746666|"     The purpose of this study is to investigate the impact of pharmacist behavioral     intervention's influence on breast cancer patients' quality of life. Croatian randomized     controlled trial. Targeted population: general population of breast cancer patients under the     first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23     questionnaire result from the baseline to after 3 week cycle.   "
41204|NCT02746302|"     This trial is conducted in China. The aim of this trial is to assess the safety and     tolerability of HS-20004 in healthy Chinese subjects.   "
41492|NCT02742519|"     To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI),     in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance     regulator (CFTR) gating mutation   "
41179|NCT02746627|"     Problems with diabetes management in adolescents with type 1 diabetes are common - occurring     at rates as high as 93% - and have serious health consequences, including poor blood sugar     control and risk for later complications. Therefore, the investigators proposed to test a     positive psychology intervention for adolescents with type 1 diabetes aimed at increasing     motivation for diabetes management; specifically, to increase the frequency of blood glucose     monitoring. This intervention will boost positive mood in adolescents (age 13-17) through     tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a     way to improve motivation for diabetes management. In addition, this study will explore the     use of technology, by comparing telephone-administered vs. automated text-messaging versions     of the intervention, to determine which mode of delivery is more appealing, convenient, and     beneficial for adolescents in managing their diabetes.      Participants and parents will complete questionnaires on mood and diabetes management during     a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes     management will be collected from participants' electronic medical records.   "
41180|NCT02746614|"     People with intellectual and developmental disabilities (IDD) usually present limitations at     adaptive behavior and motor skills, which lead to limitations/barriers in the daily     independent functioning of this population. The main goal of this research is to analyze the     efficacy of a Psychomotor Intervention Program on adults with and without IDD, through an     assessment of their progress both in adaptive behavior competences and motor proficiency     skills.   "
41181|NCT02746601|"     The purpose of the research is to identify the prevalence of preconception health (PCH) risk     factors in the Wellington-Dufferin-Guelph (WDG) catchment area and to determine whether or     not a client-driven electronic preconception health risk assessment tool My Health     eSnapshot, for use during healthcare visits, will increase preconception health knowledge     and behaviour change among women of reproductive age (15-49 years).   "
41182|NCT02746588|"     To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences     three or more miscarriages, primarily this happens during the first trimester.      These miscarriages often needs medical evacuation or a D & C. Surgery or retained tissue     increases the risk of complications as infection and/or adhesions, known as asherman     syndrome, which may result in subfertility.      Recently chronic infection in the endometrium has been proposed to contribute to the     condition, as protocols including treatment with antibiotics have led to birth at term for     some of these women.      Using the very minimal invasive office hysteroscopy, the investigators aim to describe the     uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities     in the endometrium and chromic infection.   "
41183|NCT02746575|"     Perioperative cardiac adverse events [heart injuries caused by general anesthesia and     surgical procedures] are a significant public health issue, with more than 60,000 deaths per     annum in patients having surgery for non-heart related issues. There are virtually no     evidence-based medical strategies for effective prevention of these events. Preoperative drug     treatment with beta blockade drugs used for high blood pressure, perioperative therapy with     lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high     blood pressure, and aspirin have all been investigated as potential mitigating treatments,     but without positive clinical outcomes and, in some cases, creating more hemodynamic     instabilities that result in heart injury. In light of this, investigators propose to     evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately     after surgery and to assess the value of high-sensitivity cardiac troponin level testing of     the blood in predicting those patients who would benefit most from perioperative beta blocker     therapy.   "
41184|NCT02746562|"     The purpose of this study is to compare conventional fresh embryo transfer with a freeze all     and transfer later strategy in assisted reproductive technology in terms of ongoing     pregnancy rates, live birth rates as well as perinatal outcomes.   "
41185|NCT02746549|"     In this study we want to compare the accuracy of two methods to measure renal perfusion by     MRI spin labelling technique: the first measurement done with the 1.5 T MRI versus the second     one obtained with the 3.0 T MRI (Siemens MRI device).      Additionally we want to compare the changes of renal perfusion caused by physiological     stress. The used stress test is the cold pressor test done at the forehead.   "
41186|NCT02746536|"     Background: Commonly, patients with chronic obstructive pulmonary disease (COPD) present     dyspnea, dynamic hyperinflation (DH) and important peripheral muscle deoxygenation when     performing their activities of daily living (ADLs). The slow chest compression (SCC)     technique is a physiotherapy strategy that could maybe reduce DH, dyspnea and peripheral     muscle deoxygenation in patients with COPD. The aim of the study is to analyse the effects of     SCC in DH, dyspnea and peripheral muscle deoxygenation induced by exercise tests.      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient     pulmonary rehabilitation program in Florianopolis, Brazil      Subjects: Patients with COPD (GOLD B-D).      Interventions: Patients will randomly receive or not the SCC after six-minute step test     (6MST-SCC and 6MST-NonSCC) and after six minute walk test (6MWT-SCC and 6MWT-NonSCC)      Main measures: At baseline and 1 minute after the tests, the inspiratory capacity (IC) will     be assessed by the slow vital capacity (SVC) maneuver. At baseline, immediately after, and 1     minute after the tests, the dyspnea score will be assessed. The physiological responses and     the peripheral muscle deoxygenation will be assessed during the tests and 1 minute after     them.   "
41187|NCT02746523|"     To investigate long term affects of multiple concussions on the cognition, balance,     proprioception, and biomarkers in retired National Hockey League players   "
41188|NCT02746510|"     Background:      Nowadays, despite a large number of studies about schizophrenia and genetics, clinical red     flags for syndromic forms of schizophrenia remain poorly documented.   "
41189|NCT02746497|"     As a natural part of the menopause the ovaries production of sex hormones declines. This can     lead to different menopausal related symptoms. About two-thirds of postmenopausal women     experience hot flushes and 10-20% find these hot flushes very stressful.      The aim of this study is to determine and evaluate the efficacy of acupuncture on menopausal     symptoms; in particular hot flushes. The study will be a randomized controlled trial. Primary     outcome is change in hot flushes. Secondary outcome is change in other menopausal related     symptoms.   "
41190|NCT02746484|"     The Ability research project, funded in Italy within the Smart Cities and Smart Communities     funding program (MInistry of University and Research, Operational Regional Programme,     Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development     2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart     Health Community able to provide innovative trajectories for people with cognitive     impairment, putting them at the core of a continuous and intertwining treatment and support     from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with     special focus on home-based care.      Within this framework of the Ability project the investigators test the efficacy of the     home-based motor-cognitive rehabilitation program delivered with two different approaches:     the Ability platform versus the usual care program   "
41191|NCT02746471|"     The Reveal LINQ Registry will generate reliable long-term real world data of product     performance, economic valuation, site-of-service procedural information.   "
41192|NCT02746458|"     The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be     conducted in a patient population of individuals recovering from a traumatic diaphyseal     fracture of the femur. Although the intervention can be used for any patient with muscle     weakness following trauma, the persistent thigh weakness that follows a femur fracture     provides a perfect model for evaluating the effectiveness of the REPAIR protocol.   "
41193|NCT02746445|"     The purpose of this study is to continue to evaluate the long-term effectiveness of Magnetic     EEG/ECG-Guided Resonance Therapy (MeRT) in children with Autism Spectrum Disorder (ASD). No     active MeRT treatment will be performed in this study.   "
41263|NCT02745509|"     The investigators study aims to explore the potential function of extensive intraoperative     peritoneal lavage in improving the overall survival and progression-free survival for locally     advanced gastric cancer after curative resection.      Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer     are improved by extensive intraoperative peritoneal lavage.   "
41194|NCT02746432|"     Research Problem:      Surgical stress induces inflammation and postoperative immuno-suppression, which are risk.      factors for both post-operative complication and possible disease recurrence. Colorectal     cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males.     Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of     death in these patients. Despite the new era of laparoscopic surgery, still surgical stress     is present and equally traumatic to the conventional open colorectal resection, earlier     studies showed no major differences in post-operative inflammatory and immunological     reactions. The previous studies revealed the anti-inflammatory effects of the     hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in     cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative     inflammation.      The hypothesis is Can intraoperative hyper-insulinimic euglycemic infusion reduce post     operative inflammation and immunomodulation in colon cancer patients undergoing a curative     surgery?      Research methodology Triple blinded randomized controlled study with estimated sample size of     144 patients of non-metastatic colorectal cancer patients operated at King Saud University     Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients Consented will     undergo computer randomization to receive intraoperative hyper-insulinimic normoglycemic     infusion (experimental) or standardized insulin sliding scale and saline (control). A common     preoperative and postoperative pathway with standardized management and pain control in both     groups.      Outcomes will be measured via a battery of laboratory test consist of routine labs,     inflammatory markers and immunological markers to be repeated at fixed timed intervals. All     patients will be followed by regularly for 5 years.      Research objectives      Primary outcomes to examine:        -  The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in          patients undergoing colorectal cancer surgery.        -  The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion      Secondary outcomes:        -  Thirty days post-operative morbidity.        -  Overall survival rate.        -  Disease-free survival rate.   "
41195|NCT02746419|"     This study will test the safety and efficacy of the Vessix Renal Denervation system in the     reduction of pain in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).   "
41196|NCT02746406|"     In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will     be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry     method. In the home setting a human factor/usability study will be conducted to measure the     subject's ability to perform a successful SMIP assessment at full and empty bladder with the     Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean     intermittent catheter (CIC).   "
41197|NCT02746393|"     The San Francisco General Hospital (SFGH) Health Advocate Staff II Study is a Randomized     Controlled Trial (RCT) that collects survey data and non-invasive biological data from     caregivers and children visiting a pediatric urgent care center. Families will be randomized     according to a pre-determined randomization schedule into one of two social needs-focused     interventions (the Health Advocates Program or a 211 Information active comparator arm). All     patients in the study will be followed over a six month period to capture information about     changes in social needs, health and health care utilization.   "
41198|NCT02746380|"     This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate     the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in     subjects with active Rheumatoid Arthritis despite Methotrexate therapy.   "
41199|NCT02746367|"     The purpose of this study is to validate a set of signatures, based on a panel of proteomic     markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive     episode.   "
41200|NCT02746354|"     The objective of this study is to engage patients with chronic pain and other key     stakeholders in an iterative process of pilot-testing a validated patient generated     instrument, the Measure Yourself Medical Outcome Profile (MYMOP), to support primary care     encounters and provide a direct comparison between a strategy of incorporating patient     reported outcomes into the package of care for complex pain patients and usual care. The     specific aims of this phase of the project are to: 1) adapt the MYMOP for use in the primary     care setting well-integrated into everyday practice flow, and 2) evaluate whether the     utilization of the MYMOP data in routine primary care encounters results in improvements in     patient symptoms and functioning over time as well as increased satisfaction with the visit     for patients and primary care providers. To achieve Aim 2, the investigators will compare the     reported outcomes and health care utilization from participating patients in this study for     whom the MYMOP-based instrument will be used in routine clinical care to a matched group of     chronic pain patients who will not receive the MYMOP-based assessment but will otherwise have     similarly collected data. This also allows us to evaluate of the extent to which use of the     tool adds patient-centered information to more conventional instruments. In addition to these     two aims, for a third aim, the investigators plan to collect qualitative data from patients,     their family members, Kaiser Permanente Northwest (KPNW) health care providers, and KPNW     administrators to better understand the needs of this subpopulation of patients.   "
41205|NCT02746276|"     Children with severe malnutrition who are admitted sick to hospitals have a high mortality,     usually because of infection. All children with severe malnutrition admitted to hospitals are     treated with antibiotics. However, policymakers are not sure that the current antibiotics are     the most effective. It is possible that the antibiotics that are currently used as     second-line should be used first. Finding this out will need a large trial comparing     different antibiotics. To prepare for such a trial the investigators first want to make sure     that the doses given are correct for malnourished children. The investigators also want to     check whether malnourished children more commonly carry resistant bacteria in their feces     than well-nourished children. The study is important because the types of antibiotics and the     doses needed to fight infection may be different in malnourished children because of the     changes in their body due to malnutrition and the types of bacteria present.   "
41206|NCT02746263|"     The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the     treatment of acute moderate to severe pain in combination with standardized     patient-controlled analgesia (PCA) in adult subjects following total knee replacement.   "
41209|NCT02746224|"     This is an interventional, controlled and randomized single-center clinical trial with     patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy     or laparoscopic low anterior resection for rectal cancer.      All patients included in the study (study 1) are randomized into two groups (group 1A and     group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric     vein (IMV) and in the group 1B the surgical technique initially dissects the inferior     mesenteric artery.      The patients who will undergo a colorectal anastomosis will be included in the study 2 and     will be randomized to group 2A and group 2B: in group 2A the patients will have a     latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal     anastomosis.      Study hypothesis:      Study 1: the surgical technique that initially dissects the IMV presents a greater number of     total resected lymph nodes compared to the technique that initially dissects the IMA.      Study 2: latero-terminal anorectal anastomosis has a better anorectal functional outcome than     termino-terminal anorectal anastomosis.      Primary outcome measures:        -  Study 1:To compare the total number of resected lymph nodes and the distance to the          surgical margins between the two arms (1A and 1B).        -  Study 2: to compare the anorectal functional outcome at 12 months after surgery or          ileostomy closure between the two arms (2A and 2B). The anorectal function will be          assessed by the scores of the validated Colorectal Functional Outcome Questionnaire          (COREFO) and the validated scale LARS (Syndrome anterior resection of the rectum).      Secondary outcome measures:        -  Study 1: to compare the duration of surgery, bleeding and need for surgical conversion          between the two arms (1A and 1B). Another objectives are to compare the incidence of          postoperative complications (measured by the Clavien-Dindo classification) and survival.        -  Study 2: to compare the quality of life and anorectal functional outcomes at : 6, 12, 18          and 24 months after intervention (or ileostomy closure) between the two arms (2A and          2B). The anorectal function will be assessed by the validated COREFO questionnaire and          the LARS scale. The quality of life will be assessed by the validated questionnaire of          quality of life: SF-36. Another objective is to compare the incidence of postoperative          complications assessed by the Clavien-Dindo classification and the incidence of          anastomotic leakage.   "
41210|NCT02746211|"     A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99)     virus for use in other Influenza challenge studies for the development of Influenza vaccines,     antiviral agents and to better understand the host response to Influenza infection.   "
41211|NCT02746198|"     The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and     duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication     therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory     study.   "
41212|NCT02746185|"     The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous     dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority     open label randomized multicenter trial with blinded adjudication of outcome events.   "
41213|NCT02746172|"     The aim of this research is to investigate the potential use of specific metrics in assessing     the quality and optimising an individual's cochlear implant fitting. Assessment of the     sensitivity and specificity of specific metrics that are potential predictors of inaccurate     T-levels and C-levels is important to determining best methods for streamlined high quality     fitting, providing the potential for feedback to the individual and clinic, as well as     automated adjustments for optimisation. Ultimately the objective is to increase clinical     capacity for managing both the installed base and new candidates for cochlear implantation.   "
41214|NCT02746159|"     The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic     abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.     Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and     followed clinically for a minimum of 12 months.   "
41215|NCT02746146|"     The main objective of this study is to show that the systematic use of a prognostic score as     early as possible after the initiation of dialysis in patients over 70 years of age and with     a good prognosis at 3 years of dialysis results in an increase in the number of entries on a     kidney transplant waiting list at 12 months after the initiation of dialysis.      This prospective assessment is carried out as part of a historico-prospective before-after     study in parallel with a survey of changes in national practices over the same time period     via a here-elsewhere type study.      Historical data (i.e the. before period) will include incident dialysis cases during the     calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. after     period, which is represented by the current declaration); since a preliminary study     demonstrated that the data are comparable from 2011 to 2013, we will use the average of data     thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology     and Information Network) registry data and will be validated by investigators at each center.   "
41216|NCT02746133|"     The purpose of this study is to characterise the patient and disease profile under the     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),     focusing on the progression of chronic renal insufficiency, calcium and phosphorus     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as     the persistent dietary education to ensure compliance in a large group of pre-dialysis     patients.   "
41217|NCT02746107|"     Randomized study concerning the effect of the number of risk diagrams (with treatment +/-     without treatment), the period of stroke risk estimation (one year or five years) and the     target of prescription (the patient with atrial fibrillation or the physician himself,     imagining she/he has atrial fibrillation) on the intention to prescribe or not oral     anticoagulation.   "
41218|NCT02746094|"     The primary objective of this study is to evaluate changes in erectile function (EF) before     versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy     (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile     Function) scores.   "
41219|NCT02746081|"     In patients with IDH1-R132X-mutant solid tumors treated with BAY1436032:        1. Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended phase II          dose (RP2D) of BAY1436032;        2. Evaluate the pharmacokinetic (PK) properties and pharmacodynamic (PD) effects of          BAY1436032;        3. Look for preliminary evidence of clinical efficacy in patients treated with BAY1436032;        4. Evaluate effect of standard high-fat, high calorie meal on the PK of BAY1436032.   "
41298|NCT02745054|"     The goal of SOAR is to characterize the clinical and economic impact of clinicians' responses     to major bleeding complications and pre-procedural concerns for bleeding risk in patients     treated with oral anticoagulants (warfarin, anti-Xa orals, and anti-thrombin (IIa) orals) who     present to the ED or in the hospital with acute illness or injury, with the eventual aim of     informing the development of improved approaches to the management of OACs in the ED.   "
41223|NCT02746029|"     Heart murmurs are commonly discovered in young children during clinical encounters in general     practice. Heart murmurs might signal a structural cardiac disease that need to be treated,     such as atrial septal defect. Thus, children with heart murmurs are routinely referred to     comprehensive cardiac examination at a paediatric hospital department featuring     echocardiography ('gold standard'). However, the great majority of such murmurs are innocent     or physiological; ie., they do not represent a cardiac disorder. The prevalence of such     innocent murmurs during routine random auscultation is estimated at 30 %.      It would be advantageous if patients with a heart disease to a greater extent could be     identified at the general practitioners' office:        -  Healthy children would not be exposed to comprehensive cardiac examination        -  The burden on the family would subside.        -  Scarce medical resources in highly specialized departments would be better allocated, to          the benefit of patients with real heart disease.      The primary aim of this study is to establish the predictive value of cardiac markers in     children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac     ultrasound examination in general practice; b) To establish age-adjusted reference range for     cardiac markers in children, and c) To explore aspects of cardiovascular physiology in     children.      The investigators will include a total of 500 children aged 4 weeks to 10 years who is     consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for     assessment of heart murmurs. All participants will be subjected to clinical examination,     symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other     biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also     undergo echocardiography performed by a general practitioner who has not received formal     training in pediatric cardiology. The value of possible predictors will be assessed through     the construction of Receiver Operating Characteristics (ROC) curves, and calculation of     negative predictive value.   "
41224|NCT02746016|"     This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula     intolerance in healthy term infants.   "
41225|NCT02746003|"     Background (brief):        1. Burden:           Excessive salinity is common in groundwater aquifers across south-western coastal          Bangladesh. Higher adult mean systolic and diastolic blood pressure and increased risk          of gestational hypertension has been observed among those who drank tube-well water with          high sodium content.        2. Knowledge gap:           Managed Aquifer Recharge (MAR) systems, that inject freshwater into shallow aquifers,          reduce drinking water salinity, have been successfully installed in the south-western          area, providing year-round freshwater. However, the health benefits and risks of MAR          water have not been measured.        3. Relevance:      If drinking MAR water can reduce hypertension in adults and pregnant women, while showing     minimal risk of microbiological and chemical contamination, scale up can be considered.      Hypothesis (if any):      Mean systolic and diastolic blood pressure will be lower among the adult population who drink     MAR water compared to people drinking saline or brackish groundwater Objectives: To determine        1. If providing access to MAR water for drinking and food preparation reduces blood          pressure among the adult population > 20 years of age.        2. If providing access to MAR water for drinking and food preparation during pregnancy can          reduce blood pressure among pregnant women.        3. If MAR water is contaminated with E coli and fecal coliforms.        4. Whether the MAR water is contaminated with dissolved constituents mobilized from aquifer          sediments that are known to be harmful to human health.      Methods:      A stepped-wedge RCT will be conducted among communities before and after the intervention     roll out. Study investigators will collect baseline information from all sites in the first     monthly block (step) when no one will drink MAR water. There will be promoters who will     convey messages regarding exclusive use of MAR water for drinking and cooking, at home and     elsewhere. Measurements will be made by trained research assistants once every month. MAR     water, pond water, groundwater and household stored water samples will be collected and     tested once every month.   "
41226|NCT02745990|"     In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and     function were associated with intermittent or sustained systemic inflammation (ISSI). Since     EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic     properties. Based on its potential for neuroprotection, the prospective randomized and masked     study was designed to determine whether rhEPO （500u/kg) was also effective in improving     developmental outcomes for extremely low gestational age newborns.   "
41227|NCT02745977|"     Breast feeding is the most nutritious form of nourishment in infants and is recommended for     at least the first four months of life. Breast fed infants may develop milk protein     intolerance. The management of breast milk protein intolerance differs from that of cow's     milk protein intolerance in formula fed infants. Because breast milk is considered by many to     be nutritionally superior to formula and results in maternal infant bonding mothers are often     told to continue breast feeding. Despite the lack of evidence based data to support or refute     the modification of the mother's diet, it is suggested that they eliminate their own intake     of dairy products strictly and avoid supplementing with a cow's milk based formula.     Investigators are doing this study to demonstrate that the deletion of dairy from the diet of     a breast feeding mother will not cause breast milk protein intolerance to resolve.   "
41228|NCT02745964|"     The purpose of this study is to investigate and compare the incidence of the postoperative     sore throat between LMA supreme and I-gel.   "
41229|NCT02745951|"     The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of     administering Heliox in cardioplegia during cardiac surgery and whether it has the potential     to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.   "
41230|NCT02745938|"     Mitochondrial disorders are a group of inherited disorders causing malfunctional     mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore     give symptoms from every tissue, especially those with high energy needs as the brain, heart     and muscles. The symptoms are often unspecific in terms of muscle weakness and fatigue, which     delays the first contact to the doctor and further delays the diagnosis.      The aim of this study is to investigate if it is possible to use GDF-15 (Growth and     Differentiation Factor 15) as a biomarker for mitochondrial disease and compare the results     with that of healthy controls, metabolic myopathies and muscular dystrophies. The     concentration relative to exercise will further be investigated.   "
41231|NCT02745925|"     The main iron regulatory protein in the human metabolism is hepcidin. In normal weight,     healthy subjects, hepcidin is regulated through the iron status of the body: low iron status     results in low hepcidin concentrations, which facilitates dietary iron absorption. In     obesity, which is an inflammatory state, hepcidin concentrations are increased and iron     absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether     lowering the chronic low-grade inflammation during a limited treatment period and thereby     lowering hepcidin concentration can improve iron absorption is uncertain.   "
41232|NCT02745912|"     The purpose of this study is to determine the effect of multiple oral doses of     naltrexone/bupropion on the pharmacokinetics (PK) of a single oral dose of metformin.   "
41553|NCT02741726|"     The purpose of this study is to compare the effects of dual acupoints and single acupoint     transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of     Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.   "
41722|NCT02739516|"     The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH)     co-administration with human chorionic gonadotrophins trigger for women with unexplained     infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI)     cycles .   "
41234|NCT02745886|"     The fact that metformin treatment has been associated with reduced risk of cancer and     cardiovascular disease raises the possibility of a beneficial role of metformin for other     age-related diseases. The actions of metformin resemble the effects of calorie restriction     (CR) to some extent, and microarray analyses have shown that metformin induces a gene     expression profile that aligns with that of CR in animal. The aim of the study is to     investigate whether metformin treatment can induce dietary restriction-like state in human.      Sixty overweight subjects will be included in this study, and participants will be divided 3     groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet     group, and CR group. All subjects will be treated 6 months. At the end of this study, blood     samples and muscle samples will be obtained.   "
41235|NCT02745873|"     The toxic nature of lead has been recognized ubiquitous for than 2,000 years and today it is     a persistent and common environmental contaminant in most parts of the world. Vitamin C is a     strong antioxidant and a metabolic co factor playing an important role in many biological     processes and biochemical functions (hydroxylation reactions). The research objective is to     assess the effect of oral ascorbic acid supplementation 500mg and 250 mg once a day for 4     weeks on Blood Lead level among school going urban adolescents, using a cluster randomized     trial study design. Ascorbic Acid (vitamin C) 250 and 500 mg will be administered in two     study arms.   "
41236|NCT02745860|"     Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the     tablet developed for children.   "
41237|NCT02745847|"     The safety and efficacy of re-irradiation with stereotactic body radiotherapy for relapsed     pancreatic cancer will be evaluated.   "
41238|NCT02745834|"     Case-control study to evaluate gait parameters during different conditions between patients     who suffer from chronic ankle instability and healthy individuals.   "
41239|NCT02745821|"     Comprehensive assessment of coronary physiology (fractional flow reserve (FFR), coronary flow     reserve (CFR) and index of microcirculatory resistance (IMR)) in patients with diabetes     mellitus and coronary artery disease (CAD).   "
41240|NCT02745808|"     The intent of this clinical study is to answer the questions: 1) is the proposed treatment     feasible; 2) is treatment effective in improving the disease pathology of patients with     diagnosed diabetic erectile dysfunction.   "
41241|NCT02745795|"     The objective of the study is to investigate the efficacy of motivational interview     intervention with adolescent students at a school environment on the adhesion to a     therapeutic plan to loose weight.   "
41242|NCT02745782|"     This study sought to comprehend the relationship between syncope and dental related therapy.     If the relationship between dental related therapies and syncope is proved, clinical dentists     will be remained to monitor changes of patient's blood pressure during root canal procedure.   "
41245|NCT02745743|"     The purpose of this study is to identify the most appropriate dose that can be safely     administered and that can have an effect on blood cancer cells. Once that safe dose is     identified, additional patients will be asked to join the study to further evaluate the     safety and effectiveness of the study drug. The study will also investigate the     pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics     (study of what the drug does to the body), which may provide information about the effects of     BAY 1251152. The study will also measure some biological markers (markers of biological     activity in your body) that can be used to predict the response and safety of the proposed     treatment.   "
41246|NCT02745730|"     Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure     pleasantness after consumption of four different milkshakes with added sugars or sweeteners.   "
41247|NCT02745717|"     Aim: To evaluate if additional cord blood transfusion could accelerate the hematopoietic     reconstitution in severe aplastic anemia(SAA) patients receiving immunosuppressive therapy     (IST).      Study design: open-labed, prospective, multicenter, randomized control study Number of     subjects: 60 each group      Treatment:      IST group: ATG (Thymoglobuline®, Genzyme) 3.5mg/kg/d×5d plus oral cyclosporine A (CSA) Cord     blood transfusion group: In addition to the same dose and course of ATG and CSA , one unit of     cord blood having no more than 2 HLA-A, B or DRB1 mismatches is transfused 24h after last     dose of ATG administration.   "
41248|NCT02745704|"     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with     sequential treatment of pegylated interferon alpha and NAs.   "
41260|NCT02745548|"     In order to better understand radiation-induced lung toxicity, the investigator proposes a     novel functional avoidance approach that incorporates central as well as peripheral BSS     segments in the treatment planning process in order to quantify and account for their     respective radiosensitivities. Specifically, the investigator proposes a systematic study     that involves acquiring pre- and post-SAbR high-resolution CT and SPECT V/Q scans from lung     cancer patients who receive radiotherapy, followed by auto-segmentation of the BSS elements     using virtual bronchoscopy.   "
41261|NCT02745535|"     This study will evaluate the safety, tolerability, and efficacy of     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C     infection who have failed to eradicate hepatitis C despite previous combination directly     acting antiviral therapy.   "
41262|NCT02745522|"     The current study aimed to investigate whether oxytocin (OXT) had effect on placebo     analgesia.   "
41328|NCT02743624|"     The indications for mechanical ventilation (MV) include excessive work of breathing, with or     without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge     because it is based on criteria understudied, often subjective and observer-dependent.     Despite several studies, to our knowledge has never been done before is the precise     definition of the optimal range of ventilatory support. Novel and recognizable diagnostic     techniques will be applied. No single parameter of the breathing pattern has good accuracy     for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of     muscle relaxation may have good accuracy for the adjustment of ventilatory support.   "
41249|NCT02745691|"     The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to     change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients     diagnosed with lung cancer. Participants will be enrolled in three groups according to their     primary therapy (A. Surgery, B. Radiochemotherapy, C. Targeted therapy). Various combinations     of therapies are permissible, resulting in a total of eight subgroups (A.1 Surgery alone     and/or before any adjuvant therapy, A.2 Surgery [late effects], B.1 Chemotherapy alone, B.2     Radiotherapy alone, B.3 Sequential radiochemotherapy, B.4 Concurrent radiochemotherapy, C.1     Targeted therapy alone, C.2 Targeted therapy in combination with any other therapy).      According to sample size calculations we will include a total of N = 400 patients. N = 120 of     these patients will be asked to fill in the questionnaires at a second time point, of which a     subgroup of n = 60 will be subjected to test-retest analyses (patients who are clinically     stable and indicate no change on an anchor question over the two assessment points), and     another n = 60 will be subjected to test-retest analyses (those who indicate a change to the     worse or to the better).      Standard psychometric analyses will be employed to evaluate the hypothesized scale structure     of the QLQ-LC29 and its internal consistency, convergent and discriminate validity, as well     as test-retest reliability and responsiveness to change.   "
41250|NCT02745678|"     The purpose of this study is to investigate a novel thermosensitive topical gel formulation     for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.   "
41251|NCT02745665|"     This is a pilot study with the purpose of measuring vascular function, assessed by evaluating     arterial stiffness (pulse wave velocity and augmentation index) and endothelial function     (flow mediated dilatation), in elite/amateur symptomatic male cyclists with unilateral     Endofibrosis (EF), compared to asymptomatic males cyclists and to a group of age matched     healthy males (non-athletes).   "
41252|NCT02745652|"     Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage to     continue postnatal. Conservative treatment is more recommended in these cases. There are many     physical therapy modalities proposed to treat CTS without knowing which modality is better     than the other. So the aim of this study to compare the effect of two modalities in treating     CTS in postnatal females.   "
41253|NCT02745639|"     This was a prospective phase II study on patients with locally advanced rectal cancer or     local recurrence, to evaluate the pathological response and resectability of a neoadjuvant     treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy (     XELOX).   "
41254|NCT02745626|"     Orthodontic treatment has been traditionally carried out with fixed appliances involving the     use of stainless steel brackets and archwires. The challenge has been to move teeth and their     roots effectively while minimizing iatrogenic damage such as root resorption and gingival     inflammation. In recent years, with the development of new appliances and brackets such as     self-ligating brackets and clear aligners there have been reports of improved periodontal     status, less iatrogenic root damage and improved hygiene during treatment. Although these     treatment modalities have been rapidly accepted in clinical practice, both clinical and basic     science research data regarding their overall biological compatibility to support higher     levels of evidence based dentistry (e.g, randomized clinical trials) is lacking. In other     words, their advantages and disadvantages in this regard have not yet been scientifically     evaluated. Such quantification will provide invaluable information for improvements in these     treatment modalities.      A randomized controlled clinical trial will be conducted with strict inclusion and exclusion     criteria to test the following hypothesis (H) up to 18 months into treatment:      H-1: There is no difference in the amount of root resorption caused by the three different     appliances.      H-2: Gingival health is not affected by the 'type of appliance' being used to correct the     malocclusion.      H-3: There is no difference in the amount of bacterial count and the type of appliance being     used for orthodontic treatment.      The hypothesis will be tested with the following specific aims (SA):      SA-1: To investigate the amount of orthodontically induced inflammatory root resorption     generated by treatment.      SA-2: To evaluate the periodontal health of the patients with the different appliance     systems.      SA-3: To determine the changes in Streptococcus mutans and total bacterial counts contained     in the plaque of orthodontic patients.      SA-4: To ascertain whether there is an association between the microbial count and the type     of appliance being used for orthodontic treatment   "
41255|NCT02745613|"     This study investigates weather a family history of type 2 diabetes affects exercise induced     improvements in insulin sensitivity in the hispanic population   "
41256|NCT02745600|"     The main objective of the project is to bring the existing radio frequency ablation (RFA)     model for liver cancer treatment (Project IMPPACT, Grant No. 223877, completed in February     2012) into clinical practice. Therefore the project will pursue the following objectives:      i) to prove and refine the RFA model in a small clinical study; ii) to develop the model into     a real-time patient specific RFA planning and support system for Interventional Radiologists     (IR) under special consideration of their clinical workflow needs; iii) to establish a     corresponding training procedure for IR's; iv) to evaluate the clinical practicality and     benefit of the model for use in the routine workflow in a user survey and expert forum.   "
41257|NCT02745587|"     At least 40% of the patients with prostate cancer (PC) present with positive lymph nodes     (N1). The optimal treatment strategy for these patients remains controversial. Although     androgen deprivation therapy (ADT) is still often initiated as only treatment, the results     are disappointing. Recent studies support the use of more aggressive therapies including     external beam radiotherapy (EBRT) and ADT. The retrospective studies supporting the     additional use of EBRT in N1 PC patients are however not conclusive regarding to the extent     of radiation field.      Even after an EPLND, there might be a role for pelvic EBRT in irradicating microscopic     disease. However pelvic irradiation irrevocably results in increased toxicity. Moreover, in     node negative (N0) PC patients the addition of pelvic EBRT has not resulted in improved     outcome in randomised trials. However in the setting of Tumor Node Metastasis pathological     stage (p)N1, proven on pathological examination, PC patients this has never been evaluated so     far. This trial aims to answer the question whether or not pelvic EBRT is beneficial in     pathological N1 PC patients. It is also important to realise that not all pathological N1 PC     patients have similar outcome. There is a significant impact of number of positive lymph     nodes on outcome, with two positive nodes being suggested as a significant cut-off value in     predicting survival in pathological N1 PC patients. By stratifying the patients according to     the number of lymph nodes involved this study will add to the proper selection of those     patients who will benefit most of pelvic EBRT and avoid toxicity in patients who have no     benefit of pelvic EBRT.      Additionally, small RNAs constitute potentially valuable markers for the diagnosis,     prognosis, and therapeutic choices in PC patients. Blood samples will be collected to examine     the potential role of miRNAs as a biomarker and to develop a prognostic signature for     clinical relapse-free survival.      The results of this trial will serve as a base for developping new trials in order to     optimise the treatment of patients with pathological N1 PC.   "
41258|NCT02745574|"     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter     hospitalizations, and less post-operative pain as compared with traditional laparotomies.     However, there is marked interindividual variability of post-operative shoulder-tip pain     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours     after surgery.      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic     nerve irritation causes referred pain to C4. Therefore, we should try to do is that if we     could reduce carbon dioxide retention in the pelvic cavity.      This clinical controlled trial is tried to find out the practical and clinical maneuver to     reduce post-operative should-tip pain following laparoscopic surgery.   "
41264|NCT02745496|"     The clinical trial aims to address the critical challenge of differentiating aggressive from     indolent prostate cancers by correlating prospectively collected MultiParametric (MP)     Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical     prostatectomy specimens (reference standard).      The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound     guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to     the suspicious areas identified by MRI.      The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer     aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within     the prostate gland for guiding biopsies.      Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better     inform clinicians and patients to improve risk stratification and facilitate decision making     on subsequent treatment.      Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy,     which could obviate the need for multiple biopsies.   "
41265|NCT02745483|"     The purpose of this study is to compare the therapeutic outcomes and safety of the study     patients who received radiofrequency ablation (RFA) using separable clustered electrodes with     those of a matched historical control group who had received RFA using multiple     internally-cooled electrodes.   "
41266|NCT02745470|"     The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of     brain activation and connectivity obtained by functional magnetic resonance imaging in lean     and obese type 2 diabetes   "
41267|NCT02745457|"     Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel     diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the     literature that body composition, composed of fat mass and lean mass is altered in children     with IBD compared with controls. Evidence regarding the effect of different therapeutic     approaches on body composition in children with IBD is scarce and inconsistent. Furthermore,     most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for     body composition assessment, while information on the usefulness of air displacement     plethysmography (ADP) for this assessment is lacking.      Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and     at various intervals during follow up.      Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider     Children's Hospital.      Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative     colitis (UC).      Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and     lean mass at diagnosis and during treatment.      Secondary outcome measures: Correlation of body composition to skin fold, mid arm     circumference measurements, BMI, inflammatory markers, gender, disease activity and physical     activity.   "
41268|NCT02745444|"     The key objective of this pilot study is to assess the molecular mechanisms of renal     pre-conditioning by a one-week low-calorie diet in humans.      The protective effect of the low-calorie diet and also of the protein-restriction in donor on     transplant qualities and functions in receptor will also be investigated.      Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome     through tissue samples as well as blood samples for comparison of low-calorie diet,     protein-restriction and no-diet groups.   "
41269|NCT02745431|"     The current study aimed to investigate oxytocin effect on the response after the experience     of being liked or disliked.   "
41270|NCT02745418|"     Caucasian male and female participants age 18 years of age and older will be enrolled in this     study if they have known birch or peanut allergies or known to be non-atopic. Participants     will undergo skin testing to confirm their allergies if not completed in the last 12 months.     Medications and medical history will be captured with a focus on atopic disorders.     Participants will undergo birch and peanut patch testing to assess penetration and if     potential correlation exists with filaggrin genotyping and phenotyping. Blood samples will be     drawn from participants and DNA isolated for genotyping of null mutations in filaggrin.   "
41271|NCT02745405|"     This study examined how wearing a fat suit might lead individuals to experience the negative     effects of weight based stigmatization, including psychological, behavioral, and     physiological consequences. It also aimed to test using the fat suit as a possible     intervention tactic to reduce weight stigma.   "
41272|NCT02745392|"     This is a randomized, double-blind, multi-center, parallel-group study designed to compare     the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle     systems to placebo.   "
41273|NCT02745379|"     In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal     fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the     patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft     (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by cone     beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.   "
41274|NCT02745366|"     In this study the buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad     tissue of the patients receiving posterior mandible augmentation. In the test group the     patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft     (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The control group receivesFDBA     (without any cells)+PRF. In all the groups the combination are placed between the recipient     site and the block graft obtained from lateral ramus. The results will be evaluated by cone     beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.   "
41275|NCT02745353|"     The purpose of this study is to compare the effect of naloxegol versus the patient's usual     care in treating opioid-induced constipation, as well as the effect on the patient's quality     of life and how much pain is experienced. Also, the purpose of this study is to compare     whether treatment with naloxegol versus usual care has any impact on the number of hospital     or clinic visits or telephone calls to the patient's physician that are related to     constipation, and to determine the patient's preference for continuing to receive naloxegol     as treatment for opioid-induced constipation.   "
41316|NCT02744820|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of     multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2     diabetics.      The secondary objective is to explore the effect of multiple oral doses of GMC-252 on     pharmacodynamic(PD) parameters in type 2 diabetics.   "
41276|NCT02745340|"     Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide.     It has been published in small trials or case series that the addition of acetate is     associated with a rise in nitric oxide production of vascular smooth muscle cells,     endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore     clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure     drops, induction of proinflammatory cytokines and activation of complement and leukocytes     have been described with acetate.      Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis),     Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects.     Both dialysate additives (citrate and acetate) are commercially available and are used world     wide in dialysis centers.      The investigators hypothesize that substitution of acetate by citrate reduces the     cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity     and Augmentation index) and might improves quality of life in the participants. Furthermore     the investigators speculate that citrate in the dialysis solution could reduce systemic     inflammation in the participants of the study.   "
41277|NCT02745327|"     The purpose of this study is to assess the impact of small intestine bacterial overgrowth     (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.   "
41278|NCT02745314|"     BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in     the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with poor     prognosis, the most frequent cause of heart surgery in the elderly and associates high health     costs. No variables have been identified as determinants of morbidity and mortality of these     patients and there are not algorithms developed for treatment decision-making in this     particular population. The FS as a functional reserve indicator could be a prognostic and     interventional treatment tolerance marker, and should be included in the selection of     patients for surgical treatment. The FS and cardiovascular disease (CVD) share biological     substrates among which an inflammatory state associates poor prognosis.      OBJECTIVES .- To evaluate the effectiveness of the diagnosis of FS to characterize the     prognosis of elderly patients with severe symptomatic AS representative of clinical practice.     In addition, to examine the contribution of an inflammatory state to the relationship of FS     with the prognosis of severe, symptomatic AS.      METHODS .- Prospective study during 12 months of 200 patients > 74 years old with severe     symptomatic AS. During the index visit the main clinical characteristics will be recorded and     in addition we will perform a comprehensive geriatric assessment, FS assessmet according to     Fried et al criteria (strength, walking speed, physical activity, fatigue, unintentional     weight loss) and determination of inflammatory markers (C-reactive protein and     interleukin-6). During follow-up, measures of functional impairment (basic and instrumental     activities of daily living, walking speed and timed set up & go test), hospitalizations,     death and quality of life will be determined.   "
41279|NCT02745301|"     To assess the persistence of bladder cancer-specific biomarkers in urine collected     pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel     of sensitive and specific bladder cancer biomarkers will be used to establish a signature of     disease in pre-operative patients with a positive diagnosis for bladder cancer by current     standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these     markers will be assessed, as well as the degree of non-specific signal attributable to other     sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers. Finally,     post-operative urine will be assessed for the presence of these markers. To the extent this     biomarker panel can be determined to be specific and sensitive, it may serve as an indicator     of the degree to which the surgical intervention successfully eradicated the underlying     disease. The investigators also aim to assess the stability of a biomarker signature in urine     but evaluating several patient specimens over various time points throughout the day.   "
41280|NCT02745288|"     Mandibular resection which is an important component of maxillofacial cancer surgery is an     extremely painful procedure associated with severe sympathetic response needing high doses of     opioids. Inferior alveolar nerve block is a common nerve block used by dentists for     mandibular dental extractions. The aim of this trial is to study the effect of this block for     intraoperative analgesia in maxillofacial cancer surgeries requiring unilateral mandibular     resection.   "
41281|NCT02745275|"     Canadians are living longer than ever before. However, many in our society age with long term     chronic medical conditions which have a major impact on their need for healthcare, their     quality of life and well-being. Encouragement of lifestyle practices which promote healthy     aging and self-management techniques to deal with chronic disease is important in improving     peoples' well-being      The purpose of this study is to study the impact of peer delivered education and support for     seniors living in the community to see if training given to other seniors improves healthy     ageing behaviours and their health literacy.   "
41282|NCT02745262|"     The main objective of the study is to evaluate the overall survival and disease-free survival     in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation     (COS) for fertility preservation versus women of the same age, type and stage of breast     cancer, who have not been subjected to COS.   "
41283|NCT02745249|"     Inadequate maternal nutrition is likely to undermine the potential impact of infant and young     child feeding (IYCF) improvements made in the Alive & Thrive (A&T) first phase because it is     linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These     babies do not respond to growth promoting feeding practices as well as normal newborns do. In     Phase 2, Alive & Thrive decided to focus on integrating a package of maternal nutrition     interventions in a large-scale maternal, newborn and child health program (MNCH). This     proposed evaluation aims to assess the feasibility of integrating maternal nutrition     interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized     evaluation design.   "
41293|NCT02745119|"     This multicenter open-label extension study is designed to evaluate the safety and     tolerability of lampalizumab intravitreal injections in participants with GA secondary to     age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176     (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the     parent studies who received investigational lampalizumab, as well as lampalizumab-naive     participants exposed to sham comparator. All participants will receive open-label     lampalizumab in the present study.   "
41284|NCT02745236|"     Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an     irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms     as well as increases the person's risk of stroke and heart failure. With an ageing     population, increasing rates of AF and limited access to specialists, new methods of care,     like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide     sustainable care.      The objective of the project is to evaluate the effect of Nurse Practitioner-led care in     people with AF on their quality of life.      The Canadian Healthcare system is overwhelmed, with increasing costs and wait times.     Contributing to these issues, is AF is the most common arrhythmia accompanied with costly     complications including stroke and heart failure. Currently family or emergency room     physicians ask general cardiologists or specialized cardiologists, to provide care to     patients with AF. Unfortunately, there is limited access to their services. NP's are nurses     who have taken extra education at University to treat patients and prescribe medications.     This research project involves an NP who has specialized training in AF patient management.      By utilizing an NP to provide care for patients with AF, the investigators hope to improve     patient's quality of life and satisfaction with care. This may also reduce complications of     AF.   "
41285|NCT02745223|"     A study to establish safety, tolerability, and efficacy of PresbiDrops (CSF-1) in presbyopic     subjects.   "
41286|NCT02745210|"     Despite the decline in fatal traumatic brain injury (TBI) incidence in recent years, TBI     morbidity remains a public health challenge and is the leading cause of disability in the     United States To combat these effects, new research is needed to identify mechanisms of     injury that will lead to potential targets for therapeutic interventions that improve     neurological outcome. One promising area of research is the cerebral metabolic dysfunction     following TBI. Studies of post-traumatic cerebral metabolism have shown that cerebral     metabolic rate of glucose (CMRglc) decreases for a period of days, weeks or months after     injury with the duration and degree of hypometabolism correlating to level of consciousness     and a strong predictor of long-term neurological outcome. However, specific changes in     intermediary carbohydrate metabolic pathways have not yet been identified. In addition, the     role of astrocyte metabolism in the post-injury metabolism has not been studied. This study     uses in vivo 13C magnetic resonance spectroscopy (MRS) at 3 Tesla, a novel method in the     clinical study of TBI, to non-invasively study the metabolic fate and flux of glucose     (metabolized in both neurons and astrocytes) and acetate (metabolized in astrocytes) through     metabolic pathways during the hypometabolic period. In addition, the investigators will study     the association of decreased cerebral perfusion with changes in glucose and acetate     metabolism following TBI, as changes in cerebral perfusion could profoundly affect cerebral     metabolism by limiting substrate availability.   "
41287|NCT02745197|"     This study evaluates a nutritional supplement in the treatment of pancreatic cancer in     adults. Half of the participants will receive the nutritional supplement, while the other     half will receive a placebo.   "
41288|NCT02745184|"     Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized     by a progressive damage of lung structure and decline in lung function.This study intends to     carry out an open, single-center, non-randomized, self control phase I clinical trial. During     the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in     vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy     after lavage. After twelve-month observation, the investigators will evaluate the safety and     efficacy of the treatment by measuring the key clinical indicators.   "
41289|NCT02745171|"     Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of     degenerative and progressive, with changes in the nigrostriatal pathway, and decreased     concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting     tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy,     physical therapy is also considered a useful tool for the treatment of motor disorders of the     disease. The role of physiotherapy aims to stimulate the security and independence of     patients with PD in carrying out activities and to preserve and improve physical function.     Some studies have shown the negative effect of the disease on quality of life and functional     mobility. Few studies have been conducted to evaluate the effects of long-term therapy in PD,     but many report the beneficial effects of a rehabilitation program in a short period of time.      Objective: To continually assess the effects after the completion of a physical therapy     program in patients with Parkinson's disease.      Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital     of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in     stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental.     Patients who are recruited will undergo an assessment using the scales of assessment of     functional mobility, quality of life and motor examination before starting physical therapy     at the end of treatment and two months after completion of treatment, and the intervals     assessments of a month.   "
41290|NCT02745158|"     The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry is a global,     non-interventional, voluntary database that captures demographic and disease data directly     from FOP patients and their caregivers via a secure, web-based patient portal. A physician     portal (in development) will allow physicians to enter clinical data about their patients.     The objectives are to organize the international FOP community for participation in clinical     trials; to enable FOP patients worldwide to report data in a shared forum; to improve the     collective understanding of FOP natural history; and to advance the understanding of FOP     treatment outcomes.   "
41291|NCT02745145|"     The purpose of this trial is to compare two doses of abituzumab with placebo and determine     whether abituzumab is more effective, safer, will be better tolerated and can provoke better     immune response than placebo in the treatment of patients with SSc-ILD who already receive     constant doses of mycophenolate.   "
41292|NCT02745132|"     The overall aim of this study is to evaluate the prevalence of cognitive impairments and     brain anomalies in Chronic Hepatitis C infected individuals and to investigate likely changes     in cognition and brain structure and function after treatment with Direct-acting Antivirals     (DAAs).   "
41294|NCT02745106|"     The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in     patients with chronic thromboembolic pulmonary hypertension after pulmonary     thromboendarterectomy.   "
41299|NCT02745041|"     -  Haemorrhage in severe trauma is a significant cause of mortality and is potentially the          most preventable cause of death in trauma patients        -  Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe          trauma        -  Hypo/dysfibrinogenaemia plays an important role in TIC        -  Early replacement of fibrinogen may improve outcomes        -  Fibrinogen replacement is potentially inadequate in standard fixed ratio Major          Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate        -  The majority of centres utilise cryoprecipitate for additional fibrinogen          supplementation as part of a MHP        -  Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed          ratio MHP        -  It is clear early intervention in severe traumatic haemorrhage is associated with          improved outcomes - CRASH 2 and PROPPR studies        -  Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not          supported by high level evidence        -  Benefits of FC - viral inactivation, known dose, easily reconstituted, can be          administered quickly in high dose and stored at room temperature in the trauma          resuscitation bay        -  No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients        -  Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment          algorithm        -  It will be a pilot, multi-centre randomised controlled trial comparing FC to          Cryoprecipitate (current standard practise in fibrinogen supplementation)        -  Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved          quicker with a more predictable dose response using Fibrinogen Concentrate compared to          Cryoprecipitate        -  It is imperative that robust and clinically relevant trials are performed to investigate          fibrinogen supplementation in trauma before widespread adoption makes performing such          studies unfeasible   "
41300|NCT02745028|"     Children with a radionuclide gastric emptying test with abnormal results will undergo a     second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose     of the study is to determine if a single dose of monosodium glutamate can shorten the gastric     emptying time.   "
41301|NCT02745015|"     The aim of this study is to investigate the effects of non-surgical periodontal treatment on     the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus     patients and confirmed chronic periodontitis will be selected and randomly assign to two     groups. The treatment group will receive immediate full-mouth scaling and root planing     whereas the control group will be scheduled to receive periodontal treatment at the following     3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical     attachment loss will be recorded at baseline, at six weeks and at three months. Glycated     haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three     months following enrolment.   "
41302|NCT02745002|"     Electromagnetic navigation systems have proved feasible for precise intraoperative guiding     during videobronchoscopy and endobronchial ultrasound transbronchial needle aspiration     (EBUS-TBNA), based on maps made of preoperative CT images. PET--CT, PET--MRI and fMRI can     point out malignant lesions.      When fused into a research navigation system, functional imaging can add information of     optimal sampling points in lung cancer staging. Correct image registration is then     fundamental. This study is a build--on to NCT02493023, assessing the position and image     registration accuracy and clinical feasibility of a multimodal image guiding system in     patients referred for lung cancer staging by EBUS--TBNA.   "
41303|NCT02744989|"     This project aims to provide the proof of concept for transcranial direct-current stimulation     (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to     investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial     response to a first frequently prescribed antipsychotic medication. An early optimization of     the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is     that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In     this study, stimulation is an add-on treatment to antipsychotic medication, and will be used     in a broad variety of patients, i.e. in patients with varied durations of illness, various     symptoms profiles, and various levels of treatment response. This in turn will allow the     determination of the extent to which results can be generalized to varied patient     populations, as well as the extent to which various therapeutic targets (e.g. different     symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS.     Despite interesting preliminary results, our team is unable to describe optimal non-invasive     brain stimulation (NIBS) response markers.      This study is a randomized, double blind, controlled, French multicenter study (11 centers).     The investigators plan to include 138 patients with persistent symptoms in schizophrenia.     Sixty-nine subjects will receive active tDCS and 69 subjects will receive sham tDCS     (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as     measured by the number of responders, defined as a decrease of at least 25% of symptoms as     measured by a standardized clinical scale score (PANSS) between baseline and after the     10-session tDCS regimen.      Furthermore, the participants believe that an in depth understanding of the cortical effects     of tDCS could constitute an important step towards improving the technique and developing     treatment response markers. An analysis of the effects on cortical activity and plasticity     markers could be an interesting approach.   "
41304|NCT02744976|"     Prediabetes is a disorder of glucose metabolism that reflects the natural history of     progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have     impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing     percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and     coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent     restenosis after bare metal and drug-eluting stent implantation more frequently is observed     in patients with high fasting-insulin levels and IR. Although IR has a significant role in     the progression of atherosclerosis in prediabetic patients, the importance of managing     prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment     has been officially approved for prediabetes. According to American Diabetes Association     recommendations, metformin is the only drug that could be considered in the treatment of     prediabetic patients with a high risk of developing diabetes. Metformin is a safe and     inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events     in patients with type 2 diabetes as well as the progression of atherosclerosis in     non-diabetic animal models. This study was designed to analyze coronary plaque     characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to     evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic     patients at 24 month follow up.      The study hypothesis is that more pronounced coronary atherosclerosis progression as well as     in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin     treatment attenuates the progression of atherosclerosis in patients with prediabetes.   "
41305|NCT02744963|"     This trial evaluates the effect of providing primary care patients with free and convenient     access to a set of essential medicines. Half of the participants will receive free and     convenient access to these essential medicines, while the other half will have usual access     to medicines.   "
41317|NCT02744807|"     This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe     intrauterine adhesions and compare recurrence of adhesion in women with and without CE.   "
41723|NCT02739503|"     This study set out to investigate whether antenatal ultrasound evaluation of the Fetal Head     Circumference (FHC) could potentially possess a predictive role in determining women at     increased risk for operative delivery or cesarean section.   "
47381|NCT02665429|"     This is a study of emergency physicians' prescribing patterns related to opioid (narcotic)     medications. We are trying to determine whether giving providers access to their own     prescribing data influences their prescribing patterns.   "
41306|NCT02744950|"     Surgical defects on the scalp require closure via various techniques of suture placement. A     traditional technique requires both dermal (deep) and epidermal (superficial) placement of     sutures to close the defect; this is referred to as intermediate or complex linear repair.     However, the scalp is a location with high tension, and thus the closures take an hour or     longer to perform. A type of suture placement referred to as the pulley stitch requires     placement of a few stitches along the defect. The pulley stitch can be used in areas of high     tension to close a large defect. The purpose of this study is to compare the scar results and     time taken to perform scalp closures via only pulley stitches or via intermediate/complex     linear repairs.      To my knowledge, no such study has been performed to compare the two techniques. Such a study     would be useful in demonstrating comparable scar appearance and reduce the time to perform     scalp closures.   "
41307|NCT02744937|"     Objectives: To determine whether TRUS-guided prostate biopsy performed in patients continuing     low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of     bleeding complications.      Eligibility: Men over 40-year-old with an elevated serum prostate-speciﬁc antigen level     and/or abnormal digital rectal examination ﬁndings are candidates for PB.      Design of trial Prospective Randomized Trial Study treatment: Continuing low-Dose aspirin     before transrectal prostate biopsy Primary endpoint: The incidence, duration, and severity of     bleeding complications Statistical analysis and sample size estimation: Fisher's exact test     or chi-square test will be used to explore the differences between two groups for categorical     variables, and Student t-test will be used for continuous variables. Under the assumption of     a difference of 25% of bleeding complications in each group, with α=0.05 and power=0.80, 60     subject are needed in each arm. Assuming the drop-out rate to be 20%, the targeted recruit     number is 150 in total.   "
41308|NCT02744924|"     To develop and implement a physical activity promotion intervention for older adults with or     without chronic disease living in an urban environment.   "
41309|NCT02744911|"     Telehealth, increasingly recognized in the neurology field as a solution to access issues for     people with Parkinson's disease, improves access to speech therapy, particularly those living     in rural areas or with travel barriers. The SpeechVive device, developed by SpeechVive, Inc.,     is a treatment solution that is easy to use and effective. In an NIH funded study, the     SpeechVive device improved communication in 90% of individuals with PD by improving volume,     articulation, and speech rate. The investigators propose to eliminate the one drawback of the     SpeechVive device, namely that it currently must be programmed by a speech-language     pathologist for each patient in person. The overall goal of this project is to develop a     telehealth platform for the SpeechVive device that will enable video conferencing for     treatment and remote programming of the SpeechVive device for each patient. Once the platform     has been developed, the investigators will conduct a study to examine effectiveness and the     patient and caregiver satisfaction with telepractice using the SpeechVive device.   "
41310|NCT02744898|"     The purpose of this study is to evaluate the safety of treatment with carboplatin and     Abraxane in this patient population and determine the nature and degree of toxicities     following treatment. The single stage open label Phase II feasibility study is designed to     estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with     no more than two dose level reductions.   "
41311|NCT02744885|"     The purpose of the research is to determine if participants who take Crave Crush will     report lower cravings and palatability ratings of candy as compared to subjects who receive     the placebo. Participants are self-selected university students who pass our table and     verbally agree to participate in a research study about taste preferences. Data will be     recorded anonymously.   "
41312|NCT02744872|"     Lung transplanted patients experience marked decrease in renal function post transplant     mainly due to cyclosporine induced renal changes. Calcium channel blockers may improve renal     function in cyclosporine treated transplant recipients through their effects in avoiding     cyclosporine-induced renal vasoconstriction and facilitating renal sodium output.      The aim of this study is to examine if calcium channel blockade administered before lung     transplantation prevent cyclosporine induced nephropathy.      The design is an intention to treat randomized double blinded single center study. Patients     are randomized to two groups, one that received felodipine and one that receives placebo.      Study population is all patients listed for lung transplantation in Denmark in the study     period.      Intervention is tablet felodipine titrated to 10 mg, one daily dose in 12 weeks      Primary endpoint is change in renal function as measured by glomerular filtration rate using     chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) in the felodipine treated     group compared with the placebo group.   "
41313|NCT02744859|"     Investigators will run a field study evaluating the impact different labels have on the     purchasing of sugar sweetened beverages. This field study will take place in a hospital     cafeteria.   "
41314|NCT02744846|"     The objectives of the proposed study are to assess the effects of different types, timing,     and amount of antibiotic use in the first two years of life with (Specific Aim 1) body mass     index (BMI) and obesity at ages 5 and 10 years and (Specific Aim 2) growth trajectories to     age 5 years. In Specific Aim 3, the investigators will address how big the effects of     antibiotics on obesity are within subgroups of the population, such as different     racial/ethnic groups and whether the child's mother got antibiotics while she was pregnant.      The data for this study will come from electronic medical records of about 600,000 children     from 42 healthcare systems within 10 Clinical Data Research Networks (CDRNs) across the     United States. The investigators will get information on antibiotic prescribing in the first     two years of life, then virtually follow these children to ages 5 and 10 years to see what     their BMIs are, and how many of them are obese by clinical standards (i.e., body mass index     exceeding the 95th percentile for age and sex).      In the main analyses, the CDRNs will not send any individual data to a central site. Rather,     using sophisticated computer programs, the study's coordinating center will send questions     to the data, thus protecting the privacy of patients' and the healthcare systems' records.     In some analyses, to check how well this distributed research network approach works, we     will work with individual records whose identifying information has been stripped off     (de-identified data).      In our Secondary Aim, the investigators will employ focus groups of parents and in-depth     interviews with clinicians to explore how best to put the findings into everyday practice.      Throughout the study, in addition to employing privacy-protecting approaches to analyzing and     sharing data, the investigators will adhere to principles of inclusion, patient-centeredness,     stakeholder engagement, effective governance, and protection of human subjects. At the end of     the two-year project, the investigators will propose avenues for dissemination of the     scientific findings and other products.   "
41315|NCT02744833|"     This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution     in patients with distal calf vein Deep Venous Thrombosis (DVT).   "
41318|NCT02743754|"     Kidney injury is a serious complication of cardiac surgery that occurs in up to 30% of     patients and increases the risk of adverse outcomes. Kidney injury initiates when oxygen     supply to the kidney drops below levels that are needed for normal cellular function, causing     tissue oxygen deficiency (hypoxia), activation of the inflammatory cascade, and oxidative     stress. Together, these events further impair tissue oxygenation, culminating in impaired     kidney function due to cellular injury and death.      There are no effective therapies for kidney injury after cardiac surgery, but there is     evidence that recovery is possible if the processes of injury - i.e., impaired oxygen     delivery, increased inflammatory response, and oxidative stress - are ameliorated soon after     the onset of injury. Hyperbaric oxygen therapy (HBOT) - which entails the intermittent     inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than one absolute     atmosphere (> 760 mmHg) - has been shown to positively affect all of these processes (i.e.,     to improve tissue oxygenation, reduce inflammation, and reduce oxidative stress). Thus, we     hypothesized that HBOT will reduce the severity of kidney injury after cardiac surgery if it     is initiated soon after onset of injury. This hypothesis has not been tested in humans, but     is supported by animal studies.      In this first-in-human, unblinded, controlled pilot trial, 20 adult patients who develop     severe kidney injury soon after cardiac surgery will be randomized (after obtaining informed     consent from the patient or surrogate) to standard-of-care or early HBOT. Severe kidney     injury will be defined as a ≥30% drop in kidney function within 6 hours of surgery (as     determined by change in creatinine from before surgery to Intensive Care Unit (ICU)     admission). This degree of injury occurs in ~ 2% of patients and is associated with a 12-fold     increase in the risk of complete kidney failure (requiring dialysis) or death. Patients will     be excluded if they have any relative or absolute contraindications to HBOT (e.g., severe     ventricular dysfunction, ventricular assist device, severe respiratory dysfunction,     pneumothorax, bronchospasm).   "
41319|NCT02743741|"     This is a prospective single arm, multicenter study will evaluate the efficacy and safety of     Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin     receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has     progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible     patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will     undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based     on individualized dosimetry, as well as creatinine clearance and hematological parameters.     Patients will be evaluated progression free survival at 12 months from last dose. Patients     who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be     followed until progression and acts as control group.   "
41320|NCT02743728|"     The incidence of perinatal stroke is relatively common, as high as 1 in 2,300 births, but     little is known about the resulting changes in the brain that eventually manifest as cerebral     palsy (CP). More importantly, no therapy has been devised to mitigate these specific     maladaptive changes leading to hemiplegic CP. However, motor signs that indicate the infant     is beginning to develop CP often do not become evident for several months after the diagnosis     of perinatal stroke. This delays therapy. We view the first several months after perinatal     stroke as a window of opportunity because it is known to be a critical period of     development. During this period, a well-designed intervention could minimize maladaptive     changes in the brain. To design such a science-based rehabilitation protocol for young     infants during this window of opportunity, we must first develop efficient and reliable     assessments to detect and measure maladaptive cortical reorganization in the brain.      Therefore, the main purpose of this study is to examine early brain reorganization in 3-5     months old infants with unilateral perinatal stroke using magnetic resonance imaging (MRI)     and non-invasive transcranial magnetic stimulation (TMS). In addition, the association     between the brain reorganization and motor outcomes of these infant participants will be     identified.      In this study, the MRI scans will include diffusion tensor imaging (DTI) - an established     method used to investigate the integrity of pathways in the brain that control limb movement.     Infants will be scanned during nature sleeping after feeding. The real scanning time will be     less than 38 minutes. TMS is a painless, non-surgical brain stimulation device which uses     principles of electromagnetic induction to excite cortical tissue from outside the skull.     Using TMS as a device to modulate and examine cortical excitability in children with     hemiparetic CP and in adults has been conducted previously. In this infant study, we will     assess cortical excitability from the motor cortex of both the ipsilesional and     contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation     system. Additionally, the investigators will assess infants' spontaneous movement quality     using the General Movement Assessment (GMA) procedure. This will allow the investigators to     examine the relationship between measures of motor pathway integrity and early signs of     potential motor impairment.   "
41321|NCT02743715|"     Neuromodulation techniques for the treatment of Obsessive-Compulsive Disorder (OCD) have     expanded with the greater understanding of the brain circuits involved in this disorder.     Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique     that has been studied as an alternative for strategy for treatment-resistant OCD. The main     study is a randomized, sham-controlled, double-blinded trial tDCS for OCD patients     unresponsive to cognitive-behavioral therapy and/or selective serotonin reuptake inhibitors.     Forty-four patients will be randomized to two groups: active or simulated intervention. The     intervention consisted of delivering an electric current of 2mA to the cathode, positioned     bilaterally in the cranial region corresponding to the supplementary motor cortex, and the     anode positioned in the deltoid (neutral region), during 30-minutes, for four consecutive     weeks. The primary outcome was the reduction in baseline YBOCS scores before and after of     tDCS treatment. Secondary outcomes include measures of depressive and anxiety symptoms,     genetic markers, motor cortical excitability and performance in neurocognitive tests.   "
41322|NCT02743702|"     The main objective of this study is to determine whether the Respiratory Physiotherapy allows     improvement or maintenance of respiratory function in children with Neuromuscular Diseases,     against respiratory deterioration that occurs in the group of subjects who did not receive     this treatment. And to determine whether decreasing the number of respiratory infections and     secondly the need for antibiotics and the number of emergency room visits and hospital     admissions related to these.   "
41323|NCT02743689|"     The aim of the study is to identify the incidence of early postoperative delirium in     intensive care patients after cardiac surgery and detect possible risk factors associated     with increased risk for developing delirium after cardiac surgery.   "
41324|NCT02743676|"     This is a global, multi-center, observational registry of participants with suspected or     confirmed infection with avian influenza A H5N1. Data are collected through retrospective     abstraction, from detailed case reports that may be published and available in the public     domain, or as incident cases received directly from the treating physician or other medical     personnel.   "
41325|NCT02743663|"     The study will ascertain the ability of preschool lung function tests to distinguish healthy     children from those with wheeze, and to differentiate phenotypes of wheezy children (high and     low risk for asthma as defined by API) in order to predict response to therapy, and to     explore the correlation between preschool lung function test results and symptoms, in order     to develop objective methods for monitoring asthma.   "
41326|NCT02743650|"     The goal of this pilot study is to determine whether oral sodium bicarbonate can raise low     serum bicarbonate concentration in people without chronic kidney disease (CKD). Participants     will take sodium bicarbonate for six weeks, followed by a four week washout period.   "
41327|NCT02743637|"     This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated     dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage     solid tumors.   "
41329|NCT02743611|"     This study will evaluate patients with relapsed or refractory Acute Myeloid Leukemia (AML) or     advanced hypomethylating agent-resistant myelodysplastic syndrome (MDS) who will have     autologous immune cells, called T cells, collected via apheresis. The T cells will be     reinfused according to a dose-finding schedule after the patient has been identified as     having adequate lymphopenia to provide for homeostatic expansion of the adoptively     transferred, engineered T cell therapeutic product. As a safety measure, these T cells have     been programmed with a self-destruct switch so that they can be destroyed if they start to     react against tissues (Graft versus host disease).   "
41330|NCT02743598|"     This study will test the effect of liraglutide on cognitive function in HIV-infected     overweight or obese subjects with type 2 diabetes.   "
41331|NCT02743585|"     Septic shock carries high mortality, which may be exacerbated by inappropriate initial     therapy. Inappropriate therapy may result from unanticipated antimicrobial resistance.     Conversely, positive blood cultures may result from contamination, leading to unnecessary     therapy and procedures and possibly prolonged hospitalization. Clinicians may also resort to     broad spectrum antimicrobials and be hesitant to de-escalate while awaiting susceptibility     results.      The investigators hypothesize that rapid identification of pathogens and antimicrobial     resistance will ameliorate the above problems and improve time to optimal therapy, avoid     unnecessary therapy and ultimately improve patient outcomes. While there are a number of     in-vitro and uncontrolled clinical studies, there is a paucity of well-designed clinical     trials objectively examining the real-world clinical and health-economic impact of such     technology. To date only one randomised trial has been performed in the US     (ClinicalTrials.gov NCT01898208), at a setting with low endemic rates of antimicrobial     resistance. This is a companion study to NCT01898208. The investigators aim to study the     clinical impact and cost-effectiveness of a strategy for rapid pathogen and resistance     detection in a setting with a moderate to high levels of antimicrobial resistance.   "
41332|NCT02743572|"     The purpose of this study is to determine whether iron-fortified PN is effective in the     preventative and treatment of preterm infants. Preterm infants are at risk for anemia     especially in preterm infants. Anemia effects growing development, clinical prognosis,     cognition, movement, learning ability and behavioral development.      As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral     iron administration is an efficacious method for investigators to select. For most preterm     infants, the use of parenteral nutrition(PN) is very common during the first ten days of     life, so the investigators hypothesis that iron-fortified PN may have a preventative and     treatment effect on preterm infants using PN as a supplementation of oral nutrition;     Iron-fortified PN can also improve iron store status of preterm infants. The higher     concentration of iron used in this study, the larger preventative or treatment effect on     preterm infants anemia; it is safe to add small dose of iron agent to PN.   "
41333|NCT02743559|"     Fractures in children are common and the incidence is increasing. They are more common in     children who have small, narrow and weak bones. Studies have shown that fractures in early     childhood are associated with later bone strength.      There are several (i) non-modifiable (age, gender, race, genetics) and (ii) modifiable     factors such as nutrition (vitamin D & calcium intake) and exercise that can contribute to     bone strength.      Low calcium is associated with an increased risk of fracture. Vitamin D plays a pivotal role     in bone health by increasing the absorption of calcium from the gut. Investigators know from     the previous research that there is a reduction in bone strength in children whose mothers     had lower vitamin D levels during pregnancy.      Bone growth can also be achieved by loading of bone during childhood in the form of regular     sport activities such as gymnastics and exercise programmes. Equally it can be achieved by     using whole body vibration (WBV). WBV is the application of vibratory stimulus to the body in     a synchronous fashion by which the bones are made much stronger reducing the risk of fracture     in later life. Thus WBV can be used as a means to assess bone responsiveness to mechanical     stimulation. Studies have shown that standing on a vibrating platform for 10 minutes a day     can significantly increase the bone mass. Investigators' own research has also shown that     healthy boys when made to stand on a vibration platform for 10 minutes daily for 5 days     increased the strength and quality of their bones.      Thus the role of diet and mechanical loading are of considerable interest in determining     their role in bone health and the prevention of fractures.      Maternal Vitamin D Osteoporosis Study (MAVIDOS) is a large study conducted recently at 3     different big centres (Sheffield, Southampton and Oxford). Results from this study have shown     that giving a higher dose of vitamin D to pregnant women every day from 14 weeks of pregnancy     increased the strength of the bones in their infants. In the proposed study Investigators aim     to show how vitamin D supplementation during pregnancy affects the response of bone to     vibration in children whose mothers participated in the MAVIDOS study in Sheffield. These     children will be 4 years of age when they participate in this study.      The results of this study will help inform public health policy on vitamin D intake during     pregnancy. This will also help the investigators identify a possible risk factor for poor     bone health in children.   "
41334|NCT02744781|"     This study examined whether there is an association between the presence of lumbar     intervertebral disc degeneration (LDD) and the size and symmetry of the cross-sectional areas     (CSAs) of the trunk muscles in combat sports athletes. Participants in this study were     collegiate combat sports athletes. All intervertebral discs from L1/2 to L5/S1 in all     athletes were assessed using MRI and a comprehensive grading system of LDD (grades I-V). All     151 athletes were divided into 2 groups: LDD and non-LDD. CSAs of trunk muscles at the L3/4     disc level were measured on MRI.   "
41335|NCT02744768|"     This study aims at exploring the activity of a frontline approach based on dasatinib plus     steroids administration as induction treatment, followed by the infusion of Blinatumomab, in     adult Ph+ ALL.   "
41336|NCT02744755|"     Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid     Arthritis   "
41337|NCT02744742|"     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient     tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess     blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome     (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS     undergoing allo-HSCT remains in discussion. In this prospective randomized controlled study,     the safety and efficacy of G-CSF+ Decitabine + BUCY and BUCY myeloablative conditioning     regimens in patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT are     evaluated.   "
41338|NCT02744729|"     This is an open-label single photon emission computed tomography / computed tomography     (SPECT/CT) study to investigate the safety and diagnostic performance of     99mTc-HYNIC-3PEG4-E[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of     nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously     injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative     method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse     events will be collected from the patients.   "
41339|NCT02744716|"     This study aimed To investigate the effects of estrogen in combination with aspirin and     intrauterine balloon on the uterine endometrial repair and reproductive prognosis in patients     after surgery for severe intrauterine adhesion .   "
41340|NCT02744703|"     Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin     cause degradation of the collagen proteins and loss of bond strength in adhesive     restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal     MMPs. It is hypothesised that dentin pretreatment with CAPE, as an MMP inhibitor, would be     beneficial for the bonding of resin material and tooth substrate over the course of time.     This study evaluated the effect of 5 % CAPE pretreatment on the microtensile bond strength of     a nanohybrid resin restoration applied with total-etch or self-etch adhesive systems on 10     patients (12-18 yrs). Two standard cavities (3 x 3 x 4 mm) prepared on the occlusal surfaces     of one of the two premolar teeth in each patient were randomly assigned into four treatment     groups (n=10); 5% CAPE pretreatment and total-etch adhesive (TC), Total-etch adhesive     (control) (T), 5% CAPE pretreatment and self-etch adhesive (SC), Self-etch adhesive (control)     (S) followed by restoration and 3 months of intra-oral functioning. After teeth extraction,     the specimens were stored in distilled water+thymol solution at 4°C to inhibit microbial     growth and used in one week period. Dentin-composite sticks were obtained from each     restoration for µTBS tests and scanning electron microscopy (SEM) evaluation. Failure mode     analysis was performed microscopically. Data were analysed statistically using Repeated     Measure ANOVA (p < 0.05). Dentin pretreatment with CAPE solution (5%) for 60 seconds     significantly increased the composite resin restorations' bond strengths to dentin applied     with either total-etch or self-etch adhesive system. Thus it can be used as an MMP inhibitor     prior to the the resin restorations. However further long term clinical studies are needed to     support the use of CAPE pretreatment along with self-etch and total-etch adhesive systems.   "
41341|NCT02744690|"     This study is a randomized, double-masked trial to examine the response to trabeculectomy     surgery. In this study, patients will be randomized to receive MMC via subconjunctival     injection or topical sponge application.   "
41342|NCT02744677|"     The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards     Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal     of 25% in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit with a     clinical indication for intervention.   "
41343|NCT02744664|"     This trial is to designed to assess the efficacy and safety of Cryotherapy combine with     Icotinib for Advanced NSCLC Patients harboring EGFR mutation.   "
41344|NCT02744651|"     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this     study is as follows:      - Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle     aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal     tumors in the upper GI tract.   "
41345|NCT02744638|"     The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt     containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L.     rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3     weeks following a standard antibiotic treatment with metronidazole.   "
41346|NCT02744625|"     The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and     without sedation) and in vasopressor-dependent patients   "
41347|NCT02744612|"     This phase II trial studies how well ibrutinib and brentuximab vedotin work in treating     patients with Hodgkin lymphoma that has returned (relapsed) or does not respond to treatment     (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Monoclonal antibodies, such as brentuximab vedotin, may interfere     with the ability of cancer cells to grow and spread. Giving ibrutinib together with     brentuximab vedotin may be a better treatment for Hodgkin lymphoma.   "
41348|NCT02744599|"     This is a small trial to test feasibility of an idea for a potential device. The     investigators tested the feasibility of prompting a volunteer to breathe when their breathing     had slowed down during administration of anesthetic drugs.   "
41349|NCT02744586|"     The aim of this study is to determine whether a Strengthening our Vows (SOV) intervention     will reduce HIV exposures from concurrent partnership (CP) when compared to the control Good     Health Package Plus (GHPP), in addition to couples' voluntary HIV counseling and testing     (CVCT), among concordant HIV-negative couples living in Zambia.   "
41350|NCT02744573|"     There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The     analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.   "
41351|NCT02744560|"     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.     Excess liver iron is clearly recognized as a co factor for the development of advanced     fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents     the most available noninvasive technique to assess the level of iron in the liver.there is     evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and     liver failure in those with chronic liver disease.   "
41352|NCT02744547|"     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.     Excess liver iron is clearly recognized as a co factor for the development of advanced     fibrosis in patients with hepatitis virus C infection. Hyaluronic acid serum levels correlate     with histological stages of liver fibrosis in hepatitis C patients, so it has a good     diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is evidence     that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure     in those with chronic liver disease.   "
41353|NCT02744534|"     The purpose of this study is to see if using Positron Emission Tomography (PET) scan and     transrectal ultrasound (TRUS) guided biopsy together (creating a 3-dimensional ultrasound)     will detect prostate cancer more accurately than the standard 2-dimensional approach which     uses only the TRUS to guide the biopsy.   "
41800|NCT02738502|"     The overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as     treatment simplification (switch) in pretreated pregnant women, associated with neonatal     prophylaxis with nevirapine, constituting a PMTCT strategy without any Nucleoside Reverse     Transcriptase Inhibitor (NRTIs) .   "
41374|NCT02744261|"     The purpose of this study is to (a) adapt existing user sensory perception and experience     (USPE) items/instruments generated for rectal gel/cream formulations to include USPEs     specific to suppository forms for rectal and vaginal use; (b) for both male and female     cohorts: to capture the experience of suppository use in the context of receptive anal     intercourse (RAI); and (c) for female cohort only: to capture the experience of suppository     use in the context of vaginal-penile intercourse (VI), and to compare USPEs of suppository     use in the context of RAI to USPEs of suppository use in the context of vaginal-penile     intercourse.   "
41354|NCT02744521|"     Introduction: Finding and successfully treating all tuberculosis (TB) patients is the     cornerstone of the Global Strategy to Stop TB. However, many patients in resource-limited     countries remain undiagnosed. Prisons are a well-known source of undetected TB. Thus, there     is a need to find feasible interventions to find and treat TB patients in these settings.      Objective: The objective of this study is to evaluate whether empowering and involving inmate     peer educators in TB control has an impact on increasing TB case detection rate and improving     treatment success in resource-limited prison settings.      Methodology: This is a matched cluster randomized control trial where randomization to the     intervention and treatment groups will be carried out within pairs. Eight matched prison     pairs will be randomly selected for this study in which eight prisons from each pair will be     randomly assigned to the intervention and the remaining to the control group. Trained prison     peer educators at the intervention sites will organize and provide education about TB every     two weeks on a regular basis for one year. Peer educators will also perform routine TB     screening, using a screening protocol to identify presumptive TB cases for a referral.     Identified presumptive TB cases will then be linked to the prison health personnel for a     referral to nearby hospitals. The TB diagnosis will be carried out at the referral sites     using the routine direct smear microscopy and/or chest X-ray (Radiography). Tuberculosis case     finding in the control sites will follow the existing referral system (self-referral to     nearby hospitals) and the diagnosis will be undertaken using direct sputum microscopy and/or     chest X-ray as in the intervention sites. The data will be entered using Epi Data entry     version 3.1 software and analyzed using SPSS version 20.0. Considering prisons as a unit of     analysis, the mean Case Detection Rate (CDR), Treatment Success Rate (TSR) and the percentage     of patients symptomatic for > =3 months will be compared within pairs using the paired t-test     or sign test as appropriate.   "
41355|NCT02744508|"     Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk     factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is     related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is     the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV     preventive effect of palonosetron and combination of palonosetron and dexamethasone.   "
41356|NCT02744495|"     To investigate the role of postoperative nausea and vomiting risk factors assessment after     cardiac surgery. We designed a randomized controlled study comparing standard care (no risk     factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting     after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and vomiting     by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery,     depending on risk factors (if risk score is over 2) in the intervention arm.   "
41357|NCT02744482|"     This is an experimental study, prospective, comparative. This clinical trial is randomized     and double-blind, Residronate versus placebo.      The study aims to demonstrate the effectiveness of risedronate in pain management, after 18     month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were     compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the     second a placebo.      Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive     days each month.      Evaluations are planned evry 6 months.   "
41358|NCT02744469|"     Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one     patient to another. The purpose of this study is to know to which extent, each of these     various microbes is involved in tuberculosis disease in Benin. This study will also find out     whether the type that affects a patient, depends on patient characteristics and whether the     difference affects the outcome of the treatment. Finally the study will also help to find out     whether diagnostic tests are reliable for all types of the microbe. This information will be     used after the study to inform decision making in order to improve tuberculosis control.   "
41359|NCT02744456|"     Many patients want to know which blood pressure medication is the best for them. In this     study, we will test the feasibility of a new approach to determining the best blood pressure     medication for individual patients by performing an N-of-1 trial in which patients will have     the opportunity to test a series of 3 blood pressure medications at escalating doses while     carefully measuring their blood pressure and side-effects. At the end of each of these N-of-1     trials, we will ask patients to complete a questionnaire in which they rate their level of     satisfaction with this approach to learning about which is the best blood pressure medication     for them.   "
41360|NCT02744443|"     Leucine supplementation could be useful to support muscle anabolism. This study aims to     investigate the effects of leucine supplementation on muscle mass and muscle strength in     young subjects undergoing resistance training.   "
41361|NCT02744430|"     The study will be a prospective randomized double-blind placebo-controlled trial of     mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography)     scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.   "
41362|NCT02744417|"     The aim of this prospective interventional study is to verify the efficacy of smoking     cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of     chronic periodontitis patients. Smokers willing to quit received periodontal treatment and     concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A     single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes     and applied a structured questionnaire in order to collect demographic and behavioural     information. Further, expired carbon monoxide concentration were measured with a monoximeter.     A pooled subgingival plaque sample was collected from the deepest periodontal pocket from     each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans,     Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using     (RT-PCR).   "
41363|NCT02744404|"     In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of     age) is conducted using molecular diagnostics at central laboratories. However, test volumes     are growing and many parts of the country do not have close or easy access to laboratories.     Test samples are transported over large distances and this can introduce testing delays,     especially for patients in rural and remote areas of the country. There are growing numbers     of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing     interest in using these technologies to alleviate critical testing needs. This protocol     describes an observational study looking at the patient impact of implementing POC EID     technologies within the routine standard of care at seven facilities.   "
41373|NCT02744274|"     The aim of this pilot study is to investigate the efficacy of acupuncture in prevention of     chemotherapy induced peripheral neuropathy. The study adapted a single center, randomized,     assessor- and participant-blinded, controlled, and parallel-design approach to investigate     whether acupuncture can prevent or postpone the occurrence of peripheral neuropathy and     improve quality of life.   "
41364|NCT02744391|"     This study will elucidate the neurobiology of slowing and LLD, identify a novel therapeutic     target for depression, and contribute to the development of personalized treatment regimens     for LLD. The multimodal neuroimaging methods detailed in this application will provide     information about the neurobiology of aging-associated slowing and LLD at molecular,     structural, and functional levels of analysis. These data will fill a crucial gap in our     knowledge regarding what are the physiologic and functional consequences of dopamine     depletion occurring across the lifespan in individuals without PD. Results from this project     also will allow us to evaluate a novel therapeutic approach to LLD, which could have large     public health ramifications given the prevalence, frequent treatment resistance, and     chronicity characteristic of LLD. Even apart from patients with LLD, cognitive and motor     slowing exact a large public health burden in terms of impaired functioning and increased     morbidity and mortality, and this burden will only grow as the population ages. It is     critical to develop treatments capable of altering the negative health trajectories     associated with slowing in order to help older adults maintain independent functioning and     live longer with an increased quality of life. Finally, while PET and MRI may prove critical     to understand the neurobiology of slowing and LLD, their invasiveness and expense limit their     roles in informing treatment decisions in clinical practice settings. For this reason the     investigators are also assessing the influence of genetic moderators such as interleukin-6     (IL-6) and catechol-O-methyl-transferase (COMT) genotype on baseline dopamine functioning and     response to L-DOPA. This may facilitate the identification of both high-risk individuals and     those most likely to benefit from treatment interventions.   "
41365|NCT02744378|"     This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in     symptomatic Oral Lichen Planus.   "
41366|NCT02744365|"     The Biobank includes data and biological specimens of women from three original studies: 1)     First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia     And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3)     Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and     4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following     Combined Iterative Screening.   "
41367|NCT02744352|"     The purpose of this study is to compare infraclavicular brachial plexus shot single shot     block to continuous catheter nerve block done in adult patients who have under gone surgery     to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of     recovery and quality of sleep up to 72 hours post operatively will be used for comparison.   "
41368|NCT02744339|"     The primary objective of this study is to      • Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary     hypertension and heart failure with preserved ejection fraction      The secondary objectives of this study are to        -  Assess safety and tolerability of riociguat in this study population        -  Assess changes in dimensions of left and right ventricles and cardiac function          parameters using cardiac magnetic resonance imaging   "
41369|NCT02744326|"     The investigators will conduct a prospective study and a randomized controlled trial (RCT)     involving children and adolescents presenting with a primary mental health (MH) concern to     the emergency departments (EDs) of Children's Hospitals and Clinics of Minnesota (CH). The     investigators will characterize the primary MH concerns of 800 patients and assess their     baseline access to and utilization of external resources. All enrolled patients will be     followed 3-months after their initial visit to determine ED revisits and identify factors     associated with connection to outpatient care. The RCT portion of the study will involve 200     patients discharged from the ED with a referral to an outpatient MH provider, and will test a     novel text-message communication method by which parents/caregivers can be encouraged to     complete follow-up care for their child. The experimental group will receive tailored text     message reminders regarding follow-up appointments.      Relevance: Pediatric ED visits for MH issues are increasing, but the current system of     managing these patients is not optimal. More information is needed to accelerate change and     to efficiently invest in improving services available to MH patients. Specifically,     information is needed on which MH populations need to be targeted, and on simple,     reproducible interventions which improve connection with community resources. The proposed     study will collect vital information needed to develop programs that improve outcomes and     reduce ED revisits in pediatric patients visiting the EDs at CH with primary MH concerns, and     will set the stage for future work focused on improving core and outcomes for MH youth.   "
41370|NCT02744313|"     This study will focus on a population of antipsychotic (AP) naïve adolescents and young     adults and will measure fat accumulation in relation to exposure to atypical antipsychotic     medications.   "
41371|NCT02744300|"     Women with a history of gestational diabetes mellitus (GDM) have an increased risk of     developing type 2 diabetes later in life. In our 2012 pilot study we created and tested a     web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention     Program (DPP), modified specifically for women with a recent history of GDM. This program,     delivered in the first year postpartum, encouraged weight loss, dietary changes, and physical     activity. The purpose of the current study, called Balance After Baby Intervention 2     (BABI-2), is to study a larger group of women with two years of follow-up. We will assess     whether women assigned to the intervention group lose more weight and decrease their risk     factors for type 2 diabetes.      Participants assigned to the BAB lifestyle intervention will receive support from a lifestyle     coach and gain access to a website with online presentations that contain healthy eating and     physical activity educational tips.      Participants assigned to the post-GDM follow-up group will have access to a website     containing links to information about diabetes prevention.   "
41372|NCT02744287|"     In this protocol, patients with non-resectable pancreatic cancer will have autologous T cells     collected via apheresis and genetically modified using a retrovirus to express the anti-PSCA     Chimeric Antigen Receptor (CAR). The T cells will be reinfused according to a dose-finding     schedule after the subject has been identified as having adequate lymphopenia to provide for     homeostatic expansion of the adoptively transferred, engineered T cell therapeutic product.   "
41448|NCT02743091|"     This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary     hypertension (PH) in patients with end-stage kidney disease (ESKD).   "
41375|NCT02744248|"     Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP     magnetic resonance imaging (MRI) contrast agent in healthy subjects.      Secondary:        1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy          subjects.        2. To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.        3. To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy          subjects.   "
41376|NCT02744235|"     The purpose of this study is to compare two popular portable sleep monitoring devices—the     Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app—to the gold standard     Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep     efficiency, and sleep staging. Specifically, this study will investigate the validity of the     Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in     comparison to conventional Polysomnography (PSG).   "
41377|NCT02744222|"     International multi-center double-blind comparative randomized clinical trial to evaluate     efficacy, safety and tolerance of BCD-054 (JSC BIOCAD, Russia) 120 mcg or 180 mcg     intramuscularly, biweekly and Avonex® (Biogen Idec Limited, Great Britain) 30 mcg, weekly,     for treatment of patients with remitting multiple sclerosis   "
41378|NCT02744209|"     This study will test whether immune functions in individual cancer patients can be     characterized in a quantitative manner using new technologies that analyze nucleic acids from     peripheral blood cells and whether those quantitations can be used to predict the response     outcomes of patients being treated with Pembrolizumab.   "
41379|NCT02744196|"     The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a     dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA     seropositive previously untreated with biological therapy, compared to standard therapy with     methotrexate.   "
41380|NCT02744183|"     In healthy individuals, the body responds to glucose (sugar) ingestion by reducing the amount     released from the liver. At the same time, skeletal muscles increase the rate at which they     remove the glucose from the bloodstream, via the actions of the hormone insulin. This ensures     that blood glucose levels remain in a controlled range. However, in developed countries,     diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent, due to     dietary modifications and a reduction in physical activity. As one of the prominent barriers     to regular physical activity is a lack of time, finding ways to maximize the health benefits     of exercise is a priority for researchers.      The investigators want to understand potential differences in the effects of six weeks of     aerobic training, with the exercise performed either after breakfast or after a prolonged     fast. Specifically, this research aims to investigate whether there is a difference in the     change in processes implicated in glucose regulation and secondly, in subsequent eating and     physical activity behaviors. By investigating these changes this work will explore how     exercise and nutrition can be optimized to benefit health and weight loss.   "
41381|NCT02744170|"     Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by     increasing oxygenation and reducing dyspnea. In clinical practice there are three common     oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid     oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF     involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation.     Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in     COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery     is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be     considered that the lower weight of demand oxygen delivery system might enable patients for     higher physical activity level and mobility in daily life.      The effects of These three oxygen delivery systems shall be investigated by a randomized,     controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test     and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF,     DDL or DDK) in randomized order.   "
41382|NCT02744157|"     The aim of the present study was to describe a structured intervention to reduce     cardiovascular risk in a clinical setting and to study the effects of the program on     lifestyle habits and quality of life in individuals at risk after six months and one year.   "
41383|NCT02744144|"     The purpose of the study is to explore the microbiology in war-associated wounds of     hospitalized patients from the Syrian armed conflict. Cultures collected from acute wounds     with clinical signs of infection will be analyzed.   "
41384|NCT02744131|"     Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E&P     cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS(     polycystic ovary syndrome)women from India.      Intervention:      Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with     BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for     getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged     menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at     enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference,     Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks),     Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid     Profile, FAsting blood sugar & 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25-     hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays)      Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood     sugar); GTT(glucose tolerance test)   "
41449|NCT02743078|"     This phase II trial will investigate the efficacy and safety of the addition of Optune (Tumor     Treating Fields or TTF Therapy) to bevacizumab for patients with bevacizumab-refractory     recurrent glioblastoma.   "
41430|NCT02743325|"     Supraventricular tachycardia ablations of the Conformité Européenne (CE)-certified (since     2013) CartoUnivuTM module (Biosense Webster, Diamond Bar, USA) allows a seamless combination     of a fluoro image and Carto® 3 System maps into a single view. This helps to reduce     fluoroscopy levels and reduce exposure time for physicians, staff and patients to as low as     reasonably achievable. The UnivuTM technology will be compared in a randomized manner to the     conventional radiofrequency Ablation.   "
45172|NCT02694432|"     This pilot study will evaluate the feasibility of adding an online mind-body-behavior program     to an existing behavioral self-management support platform that has been modified to promote     achievement of blood pressure goals.   "
41385|NCT02744118|"     This study adapts the Public Health Service (PHS) 5As model for use with adolescent marijuana     users and pilot the intervention to test feasibility and acceptability in pediatric primary     care settings. The specific aims are as follows:      Aim 1: Develop a marijuana screening and brief counseling intervention for adolescents based     on the Public Health Service 5As model and previously developed adolescent smoking cessation     intervention.      Hypothesis 1: The 5As model can be adapted for use as a marijuana screening and counseling     intervention for adolescents.      Aim 2: Test the feasibility and acceptability of the 5As marijuana screening and brief     counseling intervention in pediatric primary care practice.      Hypothesis 2a: Pediatric clinicians will find the 5As intervention feasible and acceptable     for addressing marijuana use in routine clinical visits with adolescents and their families;     and      Hypothesis 2b: Adolescents will find the 5As intervention delivered by their clinicians to be     acceptable in the context of routine preventive services delivery.   "
41386|NCT02744105|"     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.     Excess liver iron is clearly recognized as a co factor for the development of advanced     fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is     a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients     regardless of the degree of iron overload. There is evidence that suggests Spirulina may help     to protect against liver damage, cirrhosis and liver failure in those with chronic liver     disease.   "
41387|NCT02744092|"     The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin     vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention     strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban,     or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin.     The information gained will empower cancer patients and physicians to make more informed     choices about anticoagulation strategies to manage VTE.   "
41388|NCT02744079|"     Women post breast mass biopsy with ER+ cancer will be randomized to two diets--45 of them to     a ketogenic insulin inhibiting diet, 20 to a low fat diet simulating their existing diet, but     with added fruits and vegetables. The initial biopsy will be evaluated along with the     surgical specimen pathology to compare changes in biomarkers, particularly of proliferation     (Ki-67) and apoptosis (TUNEL).   "
41389|NCT02744066|"     Before they are born, babies are protected from hearing very loud noises by their mother's     bodies. After delivery, they are exposed to many loud noises that are potentially harmful.     These noises happen in the neonatal intensive care unit (NICU). The purpose of this research     project is to test the fit and the ease-of-use of a new device that may protect infant's     hearing in the NICU.   "
41390|NCT02744053|"     The goal of this clinical research study is to learn if investigational imaging scans can     help researchers predict which patients may respond to treatment. The results of these     investigational scans will be compared to the results of standard digital mammograms (DMs)     and ultrasound (US).      The investigational imaging scans being used on this study are:        -  Tc99m Sestamibi Molecular Breast Imaging (MBI), and        -  Dynamic Contrast Enhanced Molecular Resonance Imaging (DCE-MRI).   "
41391|NCT02744040|"     The overall objective is to determine the influence of timing of ART initiation and alcohol     consumption on HIV disease course, including detailed analysis of important events occurring     shortly after HIV acquisition. ART initiation immediately after HIV infection (during Fiebig     stages I-II) largely results in smaller HIV reservoir and lower HIV-associated systemic     inflammation, which has been linked to non-AIDS morbidity and mortality. Immediate ART also     reduces HIV-associated bacterial translocation and may prevent dysbiosis, an alteration of     the intestinal microbiota that has been linked to increased systemic inflammation. Immediate     intervention is not, however, generally feasible and more information is required about the     consequences of starting ART at later time-points, but still early after acquisition. The     proposed study will be conducted in Lima, Peru, in the cohort of 180 MSM with acute (Ab-, HIV     RNA+) or recent (≤ 3 months) HIV infection. Alcohol use disorder is present in ~50% of     HIV-infected MSM in our cohort, which is four times higher than that seen among males in the     general Peruvian population. Although the role of alcohol use in HIV pathogenesis and disease     course remains unclear, some studies show a correlation with accelerated disease progression.     In animal models and clinical studies, both acute and chronic alcohol consumption have been     linked to bacterial translocation and activation of the innate immune system, which can lead     to increases in pro-inflammatory cytokines. The effects of alcohol resemble early     post-infection changes in bacterial translocation and pro-inflammatory cytokines induced by     HIV and their impact on HIV disease course before and after ART initiation remain unexplored.      Specific Aim 1: To determine the relative long-term benefits of immediate vs. early vs.     delayed ART initiation. The investigators will study outcomes after 1.5 and 3.5 years in MSM     diagnosed with acute or recent HIV infection. The investigators will examine outcomes in 3     groups based on time of ART initiation: a) immediate: during FI-II (N~30), b) early: during     FIII-V (N~50) or c) delayed: at 24 weeks after diagnosis (N~80). The investigators anticipate     that CD4+ T cell counts and peripheral inflammatory markers in the FIII-V group and the     delayed group will approach those in the immediate treatment group (FI-II) over time; in     contrast, they expect that those started ART at early or delayed time points will have     persistent changes in the GI microbiome and in the HIV reservoir.      Specific Aim 2: To determine the impact of alcohol use on the relative long-term benefits of     immediate vs. early vs. delayed initiation of ART. The investigators will examine the impact     of alcohol use on critical events in HIV infection. They hypothesize that dose-dependent     alcohol-induced changes will compound the negative effects of HIV and lead to greater levels     of dysbiosis and inflammation, higher early plasma HIV RNA, and greater seeding and     persistence of HIV DNA in participants with high-level alcohol use. The investigators will     assess viral load, GI microbiome and metagenomics, pro-inflammatory cytokines, production of     msRNA and analyze the impact on alcohol use in all subjects prior to ART initiation and among     ART-adherent participants with persistent viral suppression.   "
41392|NCT02744027|"     Lymphatic Anomalies (LA) is characterized by proliferation of lymphatic tissue causing     deterioration of pulmonary function. Understanding changes in lymphatic anatomy in these     patients is hindered by the difficulty of imaging the lymphatic system. Dynamic Contrast     Enhanced MR Lymphangiogram (DCMRL) may be useful in investigating pathological changes in the     lymphatic system.   "
41393|NCT02744014|"     Rationale: Recent investigations suggest that, through certain concentration/meditation     techniques, it is possible to modulate autonomic activity. The results of a recent randomized     controlled trial investigating the Wim Hof Method have shown a direct biological effect on     in-vivo cytokine production and are strongly encouraging the clinical evaluation of the     technique's efficacy in immune-mediated inflammatory diseases.      Objective: To investigate whether an add-on mindset & physical therapy program based on the     Wim Hof Method can safely and efficaciously be applied in patients with active axial     spondyloarthritis.      Study design: Prospective open-label randomized controlled trial, safety and efficacy.      Study population: Twenty-four patients with active axial spondyloarthritis between 18 and 45     years of age.      Intervention: A 30-day training program of add-on mindset and physical therapy for axial     spondyloarthritis, using the methodology as designed and instructed by Wim Hof. It involves     breathing techniques, training of mindset and concentration, and gradual cold exposure.      Main study parameters/endpoints: Safety evaluation of the program is the primary aim of the     study. Secondary endpoint is the modulation of serum CRP levels. Exploratory objectives     include modulation of clinical disease activity (ASDAS), quality of life (SF-36, EQ-5D),     depressive symptoms (HADS), and predictive role of generalized and specific outcome     expectancies (EPQ-N, LOT-R, VAS scales).   "
41394|NCT02744001|"     The purpose of this study is to determine how daily diet relates to eating choices.   "
41395|NCT02743988|"     In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for     supplemental oxygen will be randomized to either Sequence of two different oxygen target     ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation,     cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary     outcome is time with arterial oxygen saturation < 80%.   "
41396|NCT02743975|"     There is a need for better visualization of resection margins and detection of small tumor     deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal     adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The     biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer     tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A     can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled     by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize     that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer     visualization using a NIR intraoperative camera system. In this pilot intervention study the     investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to     detect pancreatic cancer tissue intraoperatively.   "
41397|NCT02743962|"     Bladder pain syndrome is a condition where pain is experienced when the bladder fills with     urine and eases briefly when the bladder empties. There can also be a constant need to     urgently empty the bladder.      The internal pelvic floor muscles in people with bladder pain syndrome can be tense and     painful, and relaxing and stretching them may improve symptoms; reducing bladder pain,     urgency and how often people have to empty their bladder.      This pelvic floor release is done by specialist physiotherapists.Therapeutic wands, such as     the TheraWand®, are used routinely throughout the United Kingdom to allow people to relax and     stretch their pelvic floor themselves. Using a therapeutic wand has been shown to be safe and     to reduce pelvic pain, improve bladder and bowel symptoms and relax the pelvic floor muscles.     However, this research was conducted mostly in men with pelvic pain.      The aim of this study is to find out if using a therapeutic wand at home as well as having a     specialist physiotherapist massage the pelvic floor gives any added benefit than just having     the physiotherapy treatment. The investigators hope to find out if the therapeutic wand gives     women a way of managing their symptoms independently in their own homes.   "
41398|NCT02743949|"     The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole     for preventing heartburn symptoms over a 4-week treatment period in participants who have a     partial response to treatment with esomeprazole.   "
41399|NCT02743936|"     This is a prospective randomized cross over study of healthy volunteers undergoing continuous     positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and     without the addition of nasal cannulas. Mask leak will be measured by the ventilator after 60     seconds of spontaneous resting ventilation, with each subject serving as his or her own     control.   "
41400|NCT02743923|"     The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results     in a prolonged progression free survival compared to cisplatin-pemetrexed as first line     treatment in patients with KRAS mutated non-small cell lung cancer.   "
41401|NCT02743910|"     This study is being done to see if it is possible to use blood samples to predict response to     treatment in breast cancer patients receiving preoperative (or neoadjuvant) therapy. Research     has shown that most breast cancers release tumor-specific DNA into the blood (that is, DNA     that is specific to the tumor cells or cancer). This DNA can be detected in blood testing     known as plasma tumor-DNA or ptDNA. This DNA is separate from that found in the blood and     tissue samples which serve as the instruction book or genetic code for the cells that     make-up the human body. The changes in ptDNA before and after treatment, as well as after     surgery, may also help investigators to understand more about a patient's risk of cancer     returning and long-term outcomes.   "
41402|NCT02743897|"     This study is being conducted to determine safety and effectiveness of transplanting kidneys     from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant     waitlist, who will then be treated with Zepatier after the single kidney transplantation.   "
41403|NCT02743884|"     An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each     patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of     warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be     heat transfer, determined from inflow and outflow temperatures and fluid flow rate for     cooling and warming modes.   "
41404|NCT02743871|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and     pharmacodynamics of PF-06817024 in healthy volunteers who may be mildly atopic and in     participants with chronic rhinosinusitis with nasal polyps   "
41405|NCT02743858|"     This study is being done to find out how many women develop lymphedema after an axillary     lymph node dissection. The investigators also want to look for reasons why some women get     lymphedema and others don't. Specifically, the investigators want to do tests on the breast     tissue that is removed at the time of surgery to see if they can identify inflammation in the     breast tissue, which may increase a woman's risk for lymphedema. The investigators will also     ask the patient to answer questions to see how much their quality of life is affected by     lymphedema, and whether this study can help women by detecting lymphedema earlier.   "
41407|NCT02743832|"     The purpose of this study is to determine whether cervical lymph node dissection is     necessarily performed in the presence of early-stage oral squamous cell carcinoma.   "
41408|NCT02743819|"     Phase II study evaluating the benefit of the combination of anti-PD1 (pembrolizumab) and     anti-CTLA4 (ipilimumab) antibodies in advanced melanoma. The study will determine the     response rate of the combination and evaluate other clinical parameters such as     progression-free survival and safety of the combination following anti-PD1/L1 antibody. The     study will also provide the opportunity to investigate blood or tumor based factors that may     predict response to anti-PD1 antibody in combination with anti-CTLA4.   "
41409|NCT02743806|"     The purpose of this study is to monitor ongoing safety in subjects with ulcerative colitis     (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying subjects     who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for     whom continued treatment with vedolizumab is desired because there is no other comparable     product available or the subject may be expected to develop worsening of disease if they were     to modify treatment.   "
41410|NCT02743793|"     Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ     transplant recipients to prevent their bodies from rejecting the new organ. Some organ     transplant recipients can stop taking anti-rejection medicines without rejecting their     transplanted organ (this is called 'tolerance'). The purpose of this study will collect     samples and data from 'tolerant' liver or kidney transplant recipients in order to find out:      The purpose of this study is to collect samples and data in order to find out:        -  How long liver or kidney transplant recipients can remain tolerant;        -  What happens in the tolerant recipient's body over time; and        -  If there are patterns in the body that are linked to tolerance.   "
41411|NCT02743780|"     The purpose of this study is to determine if the clinical profile of topical-ocular MGV354     merits further development for the indication of lowering intraocular pressure (IOP).   "
41480|NCT02742675|"     The goal of this clinical research is to learn if treatment with androgen deprivation therapy     in combination with surgery or radiation therapy can prolong the progression-free survival of     oligometastatic prostate cancer than androgen deprivation therapy alone. The safety of this     treatment combination will also be studied.   "
41412|NCT02743767|"     The purpose of this study is to determine if five simple adaptations in airway management of     patients undergoing general anaesthesia can reduce minor and major airway complications.      After a first detection of causes of airway complications during general anaesthesia     investigators initiated five different interventions in airway management, which were:     immediate bag-valve mask ventilation after administering of muscle relaxants, optimized     preoxygenation, introducing of a preinterventional checklist, increased usage of video     laryngoscopy and immediate change of provider in case of failed intubation.      In a second phase of this observational study investigators want to evaluate if these five     interventions can reduce minor and major airway complications during general anaesthesia.      Additionally, investigators want to record how many critical incidents (CIRS) occur during     this observational period and how many of them will be reported by the involved stuff.   "
41413|NCT02743546|"     The purpose of this study is to determine whether duvortuxizumab and ibrutinib can be     combined safely and to establish the maximum tolerated dose (MTD) in Part 1 and the     recommended Phase 2 dose (RP2D) and to further explore the safety of duvortuxizumab in     combination with ibrutinib at the RP2D in participants with diffuse large B-cell lymphoma     (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic     leukemia (CLL) in Part 2.   "
41414|NCT02743533|"     The Silesian Cardiovascular Database is an observational study of all patients hospitalized     due to cardiovascular diseases. The date include information on the clinical characteristics,     treatment modalities and prognosis in this population.      The data include information on all the applicable diagnostic and therapeutic procedures,     prognosis and hospitalization costs. Likewise, data have been collected specialist care     outpatient visits and primary health care patients were hospitalized.   "
41415|NCT02743520|"     The purpose of this research study is to learn about arrhythmia detection in obstructive     sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having     irregular heartbeats. This study will determine how often patients with OSA have irregular     heartbeats. This study will also define which OSA patients are most likely to have irregular     heartbeats.      The participant is being asked to be in the study because the participant has been diagnosed     with obstructive sleep apnea (OSA).   "
41416|NCT02743507|"     Bundled payment is a new payment reform that encourages health care providers to improve     quality and contain costs of care. These arrangements are being rapidly expanded across the     country, but evidence about their impact are lacking. This study will use Medicare claims     data to evaluate the effect of participation in a large Medicare bundled payment program on     the quality and costs of care for common medical and surgical conditions.   "
41417|NCT02743494|"     The purpose of this study is to determine whether Nivolumab will improve overall survival,     disease-free survival, or both compared with placebo.   "
41418|NCT02743481|"     Background:      The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and     Iowa. It also included people who worked with pesticides in Iowa. They answered a     questionnaire and gave data about their children born since 1975. Researchers want to link     this data to public data like birth and death certificates. They want to study how early life     exposures to farms are linked to cancer and other bad health outcomes.      Objective:      To study data to find links between early life farm exposure and negative health outcomes.      Eligibility:      There will be no human subjects.      Design:      Researchers will get public data in the two study states. This will come from things like:      Birth certificates      Driver s licenses      Voter registration      Death certificates      Based on these plus the AHS data, they will create a study group. It will be called Early     Life Exposure in Agriculture (ELEA).      Researchers will link ELEA data to cancer data. This will identify prevalence of cancer.      They will study parents answers on the AHS. The topics include farm practices and pesticide     use. They will determine ELEA exposure to pesticides.      Researchers will analyze the cancer and pesticide results and look for links.   "
41419|NCT02743468|"     Background:      Respiratory diseases affect more than 1 billion people worldwide. They are a growing public     health concern. The lungs are constantly exposed to environmental factors such as dust,     fumes, microbes, and pollutants. But much is still not known about how these pollutants lead     to respiratory illnesses. Researchers want to collect samples from lungs and blood to see how     genetics and environmental pollutants affect cellular responses or functioning.      Objectives:      To study how cytochrome P450 epoxygenase pathway enzymes affect macrophage function in the     lungs and inflammatory responses.      Eligibility:      Adults ages 18 60 who can have a bronchoscopy.      Design:      All study visits will take place at the NIEHS Clinical Research Unit in Research Triangle     Park, NC.      At study visit 1, participants will be screened with medical history and physical exam. They     will have blood and urine tests. They will take tests that measure their lung function. They     will answer questionnaires. Before the visit, they will be given a list of medicines they     cannot take. They also must not have caffeine on the day of their visit. The visit will last     about 3 hours.      At study visit 2, participants will give blood samples. They will undergo bronchoscopy. For     this, they will get an intravenous line in a vein to get sedatives. Their airways will be     numbed. Cells will be collected from their lungs. They will fast for 8 hours before the     visit. They must have someone else drive them home from the visit. The visit will last about     3-4 hours.      Participants will get a follow-up phone call about 1 day after study visit 2.   "
41420|NCT02743455|"     This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the     safety, reactogenicity, tolerability, and immunogenicity of MVA-BN-YF in Flavivirus-naïve     healthy male and non-pregnant female adult subjects. There are six dose groups in this study.     Subjects who have never received a licensed or investigational smallpox vaccine will be     randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a     double-blinded fashion. Subjects who have previously received two, 1 x 108 TCID50 doses of     MVA-BN between 19 and 45 days apart by SC or IM routes will be enrolled in Group 6 and will     be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be     utilized. The first two subjects (1st sentinel group) one at each clinical site will be     randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without ISA 720. Subjects     and study personnel will be blinded as to whether ISA 720 was administered.   "
41421|NCT02743442|"     Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and     anatomic limits have been widened in order to extend neurosurgical applications. For many     years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale,     California, USA) has been greatly developed, especially in urology and gynecology.      Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a     minimally invasive perspective.      A robot-assisted preliminary series demonstrated the ability to approach the sella via oral     approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the     complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and     secondary atrophican rhinitis, and empty nose syndrome.      The investigators recently published a cadaveric study of transoral robotic-assisted skull     base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17).      In this study, the investigators will propose a new minimally invasive technique of pituitary     surgery by transoral approach assisted by the da Vinci robot in patients with pituitary     adenoma.   "
41422|NCT02743429|"     In this trial, monoclonal anti-Disialoganglioside GD2 (GD2) antibody ch14.18/CHO will be     assessed for the treatment of patients with relapsed or refractory neuroblastoma. The     antibody is used as a single agent applied in a new treatment schedule associated with less     side effects.   "
41423|NCT02743416|"     The STROKESTOP II study is a proposed study to determine if the biomarker NT-proBNP together     with single-lead ECG can be used as a primary population screening tool for silent atrial     fibrillation, and builds on previous results from the STROKESTOP study.   "
41424|NCT02743403|"     The project aims to compare the use of carboxiterapia ( therapeutic administration of carbon     dioxide) with the use of active TENS and placebo TENS using the VAS scale as a parameter. The     therapy used was started in the 30s , with carbonated water baths, and , lately, is involved     in the therapeutic arsenal of numerous diseases , Both for treatment of diseases when for     aesthetic treatments , especially for the gynoid lipodystrophy. However, the therapy presents     CO2 in clinical practice, limiting factors for its use , such as pain at the injection site ,     small bruises or welts due to several punctures and feeling of crepitus. To try to combat     these  side effects  that can last up to 30 minutes, the TENS was used in order to     determine whether the use of this electric current helps at improvement of discomfort.   "
41425|NCT02743390|"     Resistant hypertension (RH) is characterized by high blood pressure (BP) in spite of     concurrent use of three or more antihypertensive agents of different classes, combined at     optimal doses. Currently it has been largely discussed the influence of inflammation in RH.     The BP variation promotes increased expression of pro-inflammatory cytokines, such as tumor     necrosis factor-alpha, interleukins 1 and 6. It was showed that treatment with TNF-α     inhibitor improves BP and endothelial function, and reduces arterial stiffness in patients     with rheumatoid arthritis. Recently, it was demonstrated that TNF-α levels are increased in     RH subjects compared to normotensives. This study aims to assess whether the acute inhibition     of TNF-α changes hemodynamic parameters, such as mean BP levels in RH.   "
41426|NCT02743377|"     Background:      McCune-Albright Syndrome (MAS) is a disorder that affects the bones, skin, and some     hormone-producing tissues. It is associated with a mutation in a gene. This gene affects     enzymes in the brain and body. Researchers want to learn more about one of these enzymes,     Phosphodiesterase 4 (PDE4), in people with MAS.      Objective:      To see if people with MAS have higher levels of PDE4 than people without MAS.      Eligibility:      People ages 18 and older who have MAS and participated in protocol 98-D-0145, Screening and     Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright     Syndrome. Healthy adult volunteers are also needed.      Design:      This study requires 1 to 4 outpatient visits to the NIH Clinical Center. Some visits may take     place on the same day.      Participants with MAS will be screened with medical history and physical exam. They will have     blood and urine tests.      Participants will have a magnetic resonance imaging scan.      Participants will have a full body positron emission tomography (PET) scan. A small amount of     a radioactive chemical, [11C](R)-rolipram, will be given through an intravenous tube.      Participants will have a brain PET scan with [11C](R)-rolipram. For this, a thin plastic tube     will also be put into an artery at their wrist or elbow crease area.      For the scans, participants will lie on a bed that slides in and out of a scanner. They may     wear a plastic mask to hold their head in place. They will have blood drawn.      Participants with MAS will be interviewed about their thinking and mood. They may complete     questionnaires about how they feel or think.   "
41427|NCT02743364|"     This randomized phase II trial studies how well simvastatin works in reducing pancreatitis     (the inflammation of the pancreas) in patients with pancreatitis that occurs more than once     (recurrent), has worsened quickly (acute), or has persisted or progressed over a long period     of time (chronic). Simvastatin may decrease the inflammation of the pancreas by modulating     the immune response responsible for inflammation. It is not yet known if simvastatin may be     an effective treatment for pancreatitis.   "
41428|NCT02743351|"     This study is a Phase 1, Non-randomized, Open-label/Phase 2 Randomized, Blinded Study of     ProTmune (ex vivo programmed mobilized peripheral blood cells) Versus Non-programmed     mobilized peripheral blood cells for Allogeneic Hematopoietic Cell Transplantation (HCT) in     Adult Subjects Aged 18 to 70 years with Hematologic Malignancies. A maximum of 70 total     eligible subjects will be enrolled and treated in the trial at approximately 15-20 centers in     the US and EU.   "
41429|NCT02743338|"     This study includes two consecutive sub-trials.      Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most     important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but     lately, adverse effects related to SR have been reported. A treatment method with     similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears to     have similar effects to SR but without the adverse effects. The first sub-trial thus aims at     directly comparing SR and SC. The second sub-trial aims at evaluating any additional effects     of CBT-i components given as an add-on treatment to a randomized selection of half     participants in each original treatment arm.   "
41479|NCT02742688|"     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel     extract on decrement of body fat. The investigators measured decrement of body fat parameters     , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored     their blood pressure.   "
41431|NCT02743312|"     The goal of this pilot study is to test the protocol for investigating the longer-term     effects of torso weighting on physical activity, number of falls, and muscle activation (when     muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. The     hypotheses of this study include: torso weighting will (1) increase physical activity, (2)     decrease the number of falls, and (3) improve the timing and coordination of muscle     activation during balance perturbations.   "
41432|NCT02743299|"     The objective of this study is to determine whether healthcare professionals trained in CPR     can deliver more effective ventilations during CPR using the Handivent, a novel     turbine-driven ventilator as compared to bag-valve-mask ventilations, using a manikin model.     The investigators believe the Handivent will deliver a more accurate respiratory rate and     tidal volume, with lower intrathoracic pressure during CPR.   "
41433|NCT02743286|"     Sedentary behavior, characterized by excess sitting time during waking hours, is detrimental     to health and increases cardiometabolic disease risk, independent of moderate-to-vigorous     physical activity. The mechanisms that mediate this are unknown and there are no     evidence-based methods known for effectively intervening on sedentary behavior. The     consequences of prolonged sitting time are of particular interest in older adults as     sedentary behavior and cardiometabolic disease risk both increase with aging and     moderate-to-vigorous physical activity may not be feasible. This pilot study will assess     interventions for sedentary older adults designed to interrupt prolonged sitting time.     Interrupting sitting time through sit-to-stand transitions, and standing and walking breaks     increases muscle use and blood flow in the lower parts of the body. Thus, the investigators     believe that frequent sit-to-stand interruptions of sitting time are the most efficacious     sedentary behavior interventions, compared to simply reducing sitting time or less frequent     walking breaks, for improving health outcomes and healthy aging. The investigators     hypothesize that frequency of sit-to-stands during a 5-hour sitting period will result in     health benefits that can be observed with a simple 2-minute standing interruption, and that     this will be associated with improvements in metabolism and endothelial function. This pilot,     10-participant study will 1) generate preliminary data for a revised Program Project Grant     application to the National Institute of Aging (NIA) that focuses on postmenopausal women,     the fastest growing aged population with high life-time risk of cardiometabolic risk. This     pilot study will inform sitting interruption modality design for two projects in the     investigators' Program Project Grant application: Project 1: Sedentary Behavior Interrupted:     A randomized crossover treatment trial of acute effects on biomarkers of healthy aging in the     laboratory (86 participants) and Project 2: Sedentary Behavior Interrupted: A randomized     trial of 6 month effects on biomarkers of healthy aging and physical functioning in the real     world (660 participants). The current design of this pilot study is enhanced by and     responsive to feedback from our initial NIA submission. This pilot study will increase our     knowledge about how sedentary behavior and sitting interruption interventions influence     healthy aging in postmenopausal women.   "
41434|NCT02743273|"     Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum     creatinine and a decrease in urine output. However, applying this definition to neonates     remains challenging because of the normal renal physiologic features that serum creatinine     levels are expected to increase in the first days after birth, and impaired sodium     reabsorption and concentrating ability.      Because of several limitations of early detection of AKI, investigators are focused on     identifying biomarkers that predict AKI before an increase serum creatinine level.      Investigators will collect urine from preterm infants before and after administrating     ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators     will analyze urine by proteomics. To verify those biomarkers, investigators will use initial     urine on the first day of life from preterm infants who diagnosed AKI within 7 days after     birth without any risk factors for AKI and enrolled institutional bio-repository.   "
41435|NCT02743260|"     The objective of the present study is to contribute to establishing in vivo phenotyping     procedures for organic anionic transporter polypeptide 1B1 (OATP1B1), organic cation     transporters 1 and 2 (OCT1/2), multidrug and toxic compound extrusion transporters 1 and     2,kidney splice variant (MATE1/2K), organic anion transporters 1 and 3 (OAT1/3), and     p-glycoprotein (P-gp) transporters via a cocktail approach. To this end, marker substrates     for each of the respective transporters are administered as single doses in one period each     and as a cocktail in one period to 24 healthy volunteers, and phenotyping metrics are derived     from plasma and urine concentrations.   "
41436|NCT02743247|"     Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney     transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil,     therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic     interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction     between two drugs is still not well understood. Therefore, an open-label, three period,     single dose trial is planned to investigate the drug interaction between tacrolimus and     mycophenolate mofetil.   "
41437|NCT02743234|"     Randomized open label clinical trial to compare the clinical and microbiological efficacy of     fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium     difficile infection   "
41438|NCT02743221|"     The main purpose of this study is to evaluate the progression-free survival (PFS) in patients     receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control     arm) as first-line treatment for unresectable metastatic colorectal cancer in patients     non-eligible for intensive therapy.   "
41450|NCT02743065|"     The purpose of this multicenter registry is to gather the safety, efficacy and survival data     in advanced HCC patients treated with HepaSphere in China in order to evaluate the     application of HepaSphere deTACE in treating advanced HCC patients   "
41724|NCT02739490|"     Introduction: The stability of the pelvis is of great importance in body balance as a whole,     can be improved by training the pelvic muscles fillet (MLP), which is characterized by low     intensity isometric synchronous and the deep muscles of the trunk. This study aims to     determine the effect of a stability program target, with the training of the MLP region on     pelvic stability.   "
41451|NCT02743052|"     Purpose: Cancer associated intravascular coagulopathy is the primary mechanism of     cancer-related stroke, particularly in those without conventional stroke etiologies.     Randomized clinical trials have investigated efficacy of vitamin K-dependent oral     anticoagulant (warfarin), low-molecular-weight heparin (LMWH) and non-vitamin K-dependent     oral anticoagulant (NOAC) for the prevention of systematic venous thromboembolism. However,     relatively little is known about the biological changes underlying intravascular coagulopathy     and mechanisms of anticoagulation therapy in patients with cancer-related stroke. The aim of     this study is to evaluate to determine the biological markers for intravascular coagulopathy     causing stroke and for monitoring the effects of anticoagulation therapy, in patients with     active cancer and stroke.   "
41452|NCT02743039|"     The Northwestern University Two-Generation Child and Family Outcomes Study (NU2Gen) of the     Community Action Project of Tulsa County's (CAP Tulsa's) CareerAdvance® program examine the     effects of CareerAdvance® on child outcomes (e.g., child academic achievement and behavior).   "
41439|NCT02743208|"     In recent years, short femoral stems have been introduced. Short stems are designed based on     traditional stems with good clinical results. The assumed benefit of short stems is that they     are easier to use in mini-invasive surgery, and that preservation of proximal periprosthetic     bone stock is better. Preservation of periprosthetic bone in the proximal femur is thought to     secure long time anchoring of the implant, and reduce the risk of loosening. In addition, a     good proximal bone stock makes later revision surgery less technically demanding. However,     the short stem design could compromise the stability of the prosthesis, and there has been     reported diverging results regarding correct positioning of short stems. This may be due to     the lack of inherent aiming provided by the tip of the traditional long stems. We want to     clinically evaluate the stability and bone remodelling pattern of a new short femoral stem     based on a standard stem with excellent long time results. In addition we will compare the     two different stems regarding positioning, when using a newly developed guiding broach for     the short stem, and the standard broach for the long stem. Finally, patient reported clinical     outcome scores will be evaluated with respect to implant and biomechanical reconstruction.      The aim of this study is to evaluate whether this specific short femoral stem is stable, safe     to use, and if it provides the expected beneficial effects on bone remodelling.   "
41440|NCT02743195|"     The gastrointestinal (GI) ecosystem is a complex network of bacterial cells, host cells and     tissues that change with age. Fewer numbers and less diversity of beneficial bacteria and     greater number and diversity of non-beneficial bacteria occurs with age and conditions     associated with accelerated aging (i.e. obesity, high fat diet)(1,2). This imbalance of the     microbiota contributes to increased inflammation of the gastrointestinal lining and changes     to the integrity of the intestinal cell wall.      Prebiotics, such as non-digestible carbohydrates, can induce the growth or activity     microorganisms that contribute to the well-being of the host. Recent studies have shown that     prebiotic treatment can have beneficial effects on glucose levels, lipid metabolism, and     inflammatory markers in an obese population(3). The polyphenol blend is rich in anthocyanins,     which is a unique subgroup of flavonoids that have been demonstrated to impact the microbiome     and have anti-inflammatory properties(4,5,6,7). This open-label study will assess the     benefits of a prebiotic and polyphenol blend in healthy obese adults.   "
41441|NCT02743182|"     Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common     form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients     includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon     (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen s     (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has     been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high     probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine     HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg     loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding     PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.   "
41442|NCT02743169|"     The investigators hypothesize that spatial analysis of the location data of ambulance calls     can improve prehospital care provided by Aman Foundation in Karachi, Pakistan by decreasing     ambulance response times for high acuity patients. In Aim 1, the investigators will develop a     conceptual framework for prehospital care in low- and middle-income countries (LMICs) to     anchor this project in Aims 2 and 3. In Aim 2, the investigators will analyze the location of     calls to identify geographic areas with delayed responses for patients with higher severity     of illness. As part of their quality assurance/quality improvement practices, Aman Foundation     routinely collects location data from GPS devices in their ambulances for each call. Based on     the analyses in Aim 2, in Aim 3 the investigators will position ambulances where there are     clusters of delayed ambulance calls for high acuity patients to improve response times. This     period will be compared with a previous, control period and will be analyzed to identify     possible new clusters.   "
41443|NCT02743156|"     Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous     coronary interventions. Despite various efforts, very few preventive measures have been shown     effective in reducing its incidence.      The final volume of contrast media utilized during the procedure is a well- known independent     factor affecting the occurrence of CI-AKI.      Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during     percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise     information for guiding PCI, thereby reducing the usage of contrast media. Accordingly, the     recent MOZART study demonstrated that IVUS may lead to a 2-3-fold decrease in the volume of     contrast media during PCI.      In the present study, the hypothesize that IVUS guidance, and its consequent reduction in the     volume of contrast media, will in decrease the risk of CI-AKI after PCI, in comparison to     standard angiography-guided intervention.   "
41444|NCT02743143|"     Patients with schizophrenia have disabling symptoms and cognitive deficits that limit     motivation, drive, social- and occupational performance, quality of life and self-efficacy.     Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory     trials suggest that exercise improves cognitive functioning, symptoms, and quality of life,     and reduces the risk of cardiovascular disease. However, due to this illness, the     participation in regular exercise is challenging. In this study it will be tested if patients     with schizophrenia can participate in long-term exercise therapy, and whether long-term     supervised exercise therapy is more beneficial than today's usual care.   "
41445|NCT02743130|"     Berries have been shown to improve postprandial glucose and insulin responses to sucrose.     During processing and storage of berry products, sucrose is inverted to glucose and fructose.     The effects of berries on the glycemic response induced by inverted sugar are not known. The     purpose of this study is to determine whether berries are effective in lowering the     postprandial glucose and insulin responses induced by inverted sugar.   "
41446|NCT02743117|"     This prospective annual release study is designed to evaluate the safety of 1 new influenza     virus vaccine strains to be included in FluMist Quadrivalent for the 2016-2017 influenza     season   "
41447|NCT02743104|"     The purpose of this study is to determine whether ketamine or propofol, drugs used for     procedural sedation during paediatric bronchoscopy, results in higher operator satisfaction     and better side effect profile.   "
41453|NCT02743026|"     Indigenous youth are disproportionately represented in new HIV infection rates in Canada.     Limited studies have evaluated longitudinal effects of arts-based approaches to HIV     prevention with youth. The authors present a rationale and study protocol for an arts-based     HIV and sexually transmitted infections (STI) prevention intervention with Northern and     Indigenous youth in the Northwest Territories (NWT), Canada. This is a multi-centre     non-randomised cohort pilot study using a pre-test/post-test design with a 12-month     follow-up. The target population is Northern and Indigenous youth in eighteen communities in     the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools.     Participants will be involved in an arts-based intervention, Fostering Open eXpression among     Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the     intervention, and a 12-month follow up.   "
41454|NCT02743013|"     This clinical pharmacology study is performed to evaluate the total systemic exposure and the     lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in     healthy volunteers.   "
41455|NCT02743000|"     The proposed study will examine the role of reward and emotion in women with and without a     history of binge eating. It is important to understand how the brain responds to reward and     emotion in binge eating in order to identify different pathways toward binge eating and     provide individualized targets for treatment. This is particularly important in light of the     fact that for many patients, the current treatments for binge eating are not effective.   "
41456|NCT02742987|"     CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study     evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and     platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with     percutaneous coronary intervention (PCI).   "
41457|NCT02742974|"     The aim of this study is to determine if the incidence of post-operative complications can be     decreased by the implementation of intra-operative, minimally invasive hemodynamic monitoring     (MIHM) via FloTrac™ and EV1000™ in trauma patients.   "
41458|NCT02742961|"     Pain is common after knee replacement surgery and can impact a variety of patient outcomes.     Peripheral nerve blocks provide improved pain control and may improve function. However,     their impact on other outcomes is poorly described. Therefore, this comparative effectiveness     study will estimate the independent association between nerve blocks and health outcomes     after knee replacement surgery.   "
41459|NCT02742948|"     Objective: To determine the optimal time for intravenous antibiotic prophylaxis     administration in pregnant women undergoing elective cesarean section to minimize postpartum     infectious complication for both the mother & neonate.      Study Design: A randomized comparative study. Setting: The Obstetrics and Gynecology     department of Kasr El Aini hospital (Cairo University - Egypt) in the period from April 2016     to September 2016.      Methodology: Six hundred pregnant women aged from 20 to 40 years old with singleton living     healthy fetuses undergoing elective lower segment caesarean section (LSCS).They will be     randomized into three groups: group A in which 200 women will receive IV ceftriaxone (2g) 60     minutes before skin incision, group B in which 200 women will receive IV ceftriaxone (2g)     immediately with skin incision & group C in which 200 women will receive IV ceftriaxone (2g)     immediately after umbilical cord clamping. Outcomes include postoperative maternal & fetal     infectious morbidity.   "
41460|NCT02742935|"     This is an open-label, single center, non-randomized, dose escalation phase I trial to     evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The     primary objective is to assess safety and tolerability of SHR-1210 and identify recommended     phase II doses of SHR-1210 in patients with advanced solid tumors.   "
41461|NCT02742922|"     To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in     patients with a history of self-harm   "
41462|NCT02742909|"     To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on     pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was     administered as a continuous infusion for 24 hours , pulmonary artery pressure and other     hemodynamic parameters were monitored by Swan- Ganz catheter.   "
41463|NCT02742896|"     Erectile and Cognitive function by using the questionnaire and assessment form before sinus     conversion   "
41464|NCT02742883|"     Current therapies for diffuse, intrinsic pontine glioma (DIPG) provide very limited benefit     to the patient. The rationale for the use of Antineoplaston therapy in this protocol study     derives from experience with subjects from prior Phase 2 studies and Compassionate Exemption     patients treated with Antineoplaston therapy at the Burzynski Clinic.      This study is designed to analyze the efficacy and safety of Antineoplaston therapy in five     separate DIPG patient cohorts, which are defined by age and prior therapy. This is a two     stage study with 20 patients in each cohort being enrolled in the first stage and an     additional 20 patients being enrolled in the second stage, if pre-determined efficacy     endpoints in the first stage are realized.   "
41501|NCT02742402|"     The aim of the study is to evaluate whether patients with early equivocal appendicitis can be     observed instead of immediate diagnostic imaging. Half of the patients are randomly assigned     to observation group, while the other half will undergo diagnostic imaging. The hypothesis is     that resolving appendicitis is common in these patients. Thus, in observation group there     will be fewer patients with appendicitis diagnosis and observation reduces the use of     diagnostic imaging and surgery.   "
41478|NCT02742701|"     Diabetes prevalence in palliative care is 10-15%. Most hospice patients are treated with     insulin. The target glucose level is high in order to decrease the risk of hypoglycemia.     Glucose level is usually monitored using capillary blood glucose once to three times daily.      The aim of the research is to simplify this pattern of care in end-of-life patients. It will     evaluate whether the non invasive measurement of glucose in urine could replace the     measurement of capillary blood glucose. The first objective will be to assess the performance     of the measurement of glucosuria using urinary dip stix to predict that the blood glucose     level is within the target range.      Due to the high glucose target, hyperglycemia is extremely frequent. However, symptoms of     hyperglycemia are unfrequently reported. They may be unspecific and/or masked in end-of-life     patients due to terminal disease and medication. The second objective of the study will be to     define symptoms of hyperglycemia in these patients.   "
41465|NCT02742870|"     Diffusion-weighted sequences have been routinely performed for years to study the pelvis.     They have been so far mainly qualitatively interpreted, that is to say as the absence or     presence of an hypersignal at a high b value. The quantitative analysis involves placing the     region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual     placement is very operator dependent, and does not reflect the entirety of the studied mass.      In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating diffusion     analysis is flourishing. However, the quantitative analysis of the diffusion is still little     studied for tumor heterogeneity analysis, including in the gynecological sphere.      The investigators will therefore retrospectively evaluate the apparent diffusion coefficient     (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging     resonance analysis of adnexal masses and confront the results with the anatomo-pathology     results, for patients having undergone surgery, and/or with the clinical and imagery     follow-up results.      The investigators goal will be to improve the performance of conventional MRI in the analysis     of adnexal masses.      The expected benefits of this study are:        -  a correlation with the histology analysis or the clinical monitoring        -  an improved prediction of the malignancy of the tumor        -  an improved magnetic resonance imaging performance for adnexal masses, with better          surgical therapeutic management        -  an improved negative predictive value, thereby ultimately limiting unnecessary surgical          explorations.   "
41466|NCT02742857|"     This is the proof of concept study with multi-modality approach (using intra-thecal bioactive     peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as     adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury     to document possibility of reversal of brain death (BD).   "
41467|NCT02742844|"     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size     reduction) and safety (by monitoring occurring adverse events) of the investigational     medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.   "
41468|NCT02742831|"     This is a pilot randomized controlled trial of a behavioral intervention focused on improving     parenting skills and preventing child neglect in families of children with special health     care needs. The intervention focuses on problem solving, distress tolerance, and emotional     regulation skills.   "
41469|NCT02742818|"     Prospective randomized trial comparing effectiveness of two different forced-air warming     blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal     aortic aneurysm repair (EVAR).   "
41470|NCT02742805|"     The proposed research is intended to determine if supplementation of relatively high dose     vitamin D in chronic urticaria patients receiving omalizumab will result in continued     symptomatic control of hives after the discontinuation of omalizumab.   "
41471|NCT02742792|"     The objective of the study is to evaluate the impact of strength training on sleep apneas in     the elderly. Individuals aged between 65 and 80 years and that presenting apnea-hypopnea     index between 20 and 50 events per hour, measured by out-of-center portable polysomnography,     will be recruited. Those included will be randomized to two groups: Intervention: consisted     of 12 weeks, twice a week, of strength training; or control: consisted of lifestyle     recommendations.   "
41472|NCT02742779|"     The purpose of this study is to evaluate the safety and tolerability of single and multiple     orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including     Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a     multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution     formulation, and Part 4- a MD part using a solution formulation. Effects of food on     pharmacokinetics (PK) will also be explored.   "
41473|NCT02742766|"     This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind),     three part study. The primary objective of the study is to characterize the safety, and     tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28     daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single and     multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day, repeat-dose,     dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose study in     obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available prior to     escalation decisions. Data from Parts 1 and 2 will be available prior to initiation of the     three parallel cohorts in Part 3. A dose escalation meeting will be held to review these data     and document the decision to proceed as planned or make any alterations in dosing, if     indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30 subjects,     respectively.   "
41474|NCT02742753|"     The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on     physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish     children by collecting and analyzing patient level observational data already available in     existing regional and national databases.   "
41475|NCT02742740|"     The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting     protocol adherence and retention, providing anticipatory guidance and answering questions,     serving as a conduit to capture information about complaints or adverse events, providing a     venue for communicating about updates. The Study Buddy will use the web-based ECA     infrastructure developed for use on another project. We will use web browsers on tablets     provided to study participants to access the Study Buddy, providing anywhere, anytime access     to its functions. Usability metrics will include session time, satisfaction, and error rates.   "
41476|NCT02742727|"     The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell     immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.   "
41477|NCT02742714|"     This clinical study is designed to evaluate the PillCam SBC system performance in 50     established or suspected inflammatory bowel disease (IBD) patients by visualizing and     assessing their small and large bowel.   "
41502|NCT02742389|"     The purpose of this study is to determine whether an intervention (pre-procedure telephone     call by the investigators) will reduce anxiety in women undergoing urodynamic testing (UDT)     compared to usual care. Our hypothesis is that women who receive the intervention will report     less anxiety immediately before UDT than women who receive usual care.   "
41503|NCT02742376|"     This study compares the gait pattern of individuals with weight bearing difficulties walking     on the floor, a soft surface, or with special shoes (Kyboot).   "
41481|NCT02742662|"     The study will evaluate whether a technology-based lifestyle intervention program using     primarily a smartphone platform is an acceptable and effective way for treating obesity. The     goal of the program is to achieve weight loss and enhance the health of overweight or obese     subjects by improving their diet and activity via smartphone applications as compared with     conventional in-person weight management programs.   "
41482|NCT02742649|"     The purpose of this study is to determine if a combination of two drugs (bimatoprost and     timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular     pressure (IOP) than either of the drugs delivered alone.   "
41483|NCT02742636|"     Objective: The aim of this study is to evaluate if direct removal of the urine catheter after     an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical     hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter     removal after surgery, which is the current treatment. In addition, we want to investigate     patient's experience on this subject.      Study design: Randomized Controlled trial, non-inferiority study.      Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for     benign indication or low-grade malignancy.      Intervention:        -  Group A (treatment group): the patients in this group will have their catheter directly          removed in the OR after LH.        -  Group B (control group): the patients in the control group will have their catheter          removed according to the regular protocol of the hospital (at least 6 hours in place).   "
41484|NCT02742623|"     This study aims to collect patient reported outcomes and assess treatment satisfaction in     active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).   "
41485|NCT02742610|"     This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management     (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving     outpatient psychiatric treatment. This project is expected to result in the development of an     effective intervention that will produce preliminary data showing increased short-term     cessation success in depressed smokers receiving outpatient psychiatric treatment. It is     anticipated that this smoking cessation intervention will have potential for broad reach to     outpatient psychiatric treatment programs and have a significant overall impact in reducing     smoking-related morbidity and mortality by enhancing smoking cessation rates in at-risk     populations.   "
41486|NCT02742597|"     The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is     to reorient the health care system from a single disease focus to a multimorbidity focus;     centre on not only disease but also the patient in context; and realign the health care     system from separate silos to coordinated collaborations in care. PACE in MM will propose     multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be     grounded in current realities (i.e. Chronic Care Models including Self-Management Programs),     that are linked to Primary Care (PC) reform efforts. The study will build on this firm     foundation, will design and test promising innovations and will achieve transformation by     creating structures to sustain relationships among researchers, decision-makers,     practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is     mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 4 other provinces:     British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). The Team's     objectives are: 1) to identify factors responsible for success or failure of current CDPM     programs linked to the PC reform, by conducting a realist synthesis of their quantitative and     qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1,     by aligning them to promising interventions on patient-centred care for multimorbidity     patients, and to test these new innovations' in at least two jurisdictions and compare among     jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and     tested/proven in Objective 2, and to conduct research on different approaches to scaling-up.     This registration for Clinical Trials only pertains to Objective 2 of the study.   "
41487|NCT02742584|"     This is a multicenter, prospective, randomized comparative study in which patients are     randomized to one of four different bladder volumes and a Cough Stress Test (CST) is     performed in both the standing and sitting positions. The goal is to assess the agreement of     each CST method with both urodynamics diagnosis of Stress Urinary Incontinence (SUI) and the     24-hour pad test. The primary outcome is to determine what CST method best correlated with     either test in the diagnosis of SUI.   "
41488|NCT02742571|"     Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic     Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality,     morbidity and nutrition in ICU   "
41526|NCT02742077|"     The purpose of this study is to evaluate the safety and performance of the CorPath 200 System     in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in     percutaneous vascular interventions.   "
41489|NCT02742558|"     To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM,     Investigators will conduct a clinical trial study Bangladeshi healthy adults and children.     Cholvax is locally produced orally administered whole cell inactivated bivalent cholera     vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now     producing the oral cholera vaccine, Cholvax with technological support from International     Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP)     standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in     terms of strains and formulation. By this transfer of technology, it expected that the     vaccine will become available for use in public health programs in Bangladesh and in the     future in other cholera-affected countries in Asia and Africa to control endemic cholera, as     well as to help control large-scale epidemics and outbreaks.      Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots     (lot-to-lot consistency).   "
41490|NCT02742545|"     This study evaluates the efficacy of MayoExpertAdvisor (MEA), a knowledge delivery tool, to     improve adherence to best practices for patients with hyperlipidemia, atrial fibrillation and     heart failure. Half of the clinicians will receive MEA, while the other half will not receive     MEA.      The investigators hypothesize care teams with access to MEA will act upon recommendations at     a higher rate than those care teams in the standard of care arm without access to MEA.   "
41493|NCT02742506|"     Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged     patients. However, it is still difficult to understand what precisely in music causes a     positive effect : are they emotional components, familiarity or preference which improve     cognition or is there any specific effect of music? Moreover, it is not yet possible to     characterize the neural and functional links between the brain systems solicited by music and     those associated with other cognitive functions enhanced by music.      Finally, researches on brain-damaged patients have not exploited the potential effect of     music on the level of alert and perceptual awareness, while this type of stimulation could be     a valuable tool to improve cognition in patients with a disturbance of consciousness and     alertness.      The main objective is to describe the impact of music on the brain's response to     self-referential or neutral stimuli in brain-damaged patients with persistent consciousness     disorder after a coma and in healthy participants.   "
41494|NCT02742493|"     The present study aims to assess the effectiveness of three different retention schemes used     to maintain tooth position after orthodontic treatment with fixed orthodontic appliances     (stability) and to evaluate possible association between retention scheme and gingival     recessions on the lingual surfaces of the lower anterior teeth seen for up to 5 years     post-treatment. Moreover the possible association between primary relapse tendency and long     term occlusal stability will be evaluated.   "
41495|NCT02742480|"     SEDMAN study is a prospective multicenter investigator initiated study (IIS). The main idea     is to look by Genome Wide Association (arrays that determine more than 1 million     polymorphisms) genetic risk factors associated with response to dabigatran. To conduct the     study, the goal is to recruit 300 patients with ischemic stroke with cardioembolic etiology     treated with dabigatran and 200 treated with Acenocoumarol to determine if genetic risk     factors are associated with the occurrence of any bleeding or vascular event in a year     follow-up.   "
41496|NCT02742467|"     The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group,     three-armed superiority trial which is aimed at comparing the efficacy of three free     combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure     (ASBP) in black African hypertensive patients.   "
41497|NCT02742454|"     The purpose of this study is to determine whether providing ventilatory assistance prior to     umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in     extremely preterm (EPT) infants, compared to standard care of providing ventilatory     assistance after cord clamping.   "
41498|NCT02742441|"     This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and     safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with     plaque psoriasis.   "
41499|NCT02742428|"     Patients with significant ascites and advanced ovarian cancer (AOC), undergoing complex,     cytoreductive surgery are at risk of malnutrition, poor quality of life and the risk of hypo-     or hypervolemia in a perioperative period. All these factors may cause hemodynamic     consequences during anesthesia and surgery, and elevate the risk of morbidity and mortality.      The objective of the study is to evaluate, whether slow ascites evacuation for a few days     before the surgery for AOC, could 1) influence the hemodynamic consequences of ascites on     systemic circulation in patients undergoing surgery, 2) improve patient's quality of life and     3) ability to feed correctly before treatment starts, and thus lower the risk of     perioperative morbidity.      Eligible patients are those with significant ascites, diagnosed or suspected for AOC, who are     scheduled for primary surgery (both upfront cytoreduction or laparoscopic evaluation before     neoadjuvant chemotherapy), that cannot be performed within next 7 or more days, for any     reason. Patients will be asked to fill in quality of life questionnaire (QLQ). Clinical data,     a Subjective Global Assessment (SGA) will be recorded. Patients will be randomized to either     intervention arm A - insertion of vascular catheter into abdominal cavity and slow,     systematic, daily ascites evacuation, or to observation arm B - standard of care with just     observation (acute large volume (>5000ml) paracentesis allowed if needed). Patients in both     groups will be encouraged to use oral nutritional support. Randomization will be open, 1:1,     for every eligible, consecutive patient. After 7 days patients will be interviewed, asked to     fill in QLQ, patient's experience on the treatment survey, a SGA will be recorded. During the     first hour of the surgery hemodynamic data from anethetic charts will be recorded along with     other clinical data concerning patient's characteristics, surgery details and 30-day     postoperative follow-up. A template is provided.      The hypothesis of the study is that slow, systematic ascites evacuation few days before     surgery for advanced ovarian cancer can facilitate hemodynamic control of systemic     circulation of patients undergoing surgery, and improve patients' quality of life, feeding     ability before treatment starts. Secondary we would expect lower risk of perioperative     morbidity and mortality.   "
41500|NCT02742415|"     Since there is a limited amount of evidence on the feasibility and outcomes on the use of     hand massage in patients undergoing cancer treatment, the purpose of this study is to     evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing     chemotherapy, and to measure its influence on their symptoms.   "
41725|NCT02739477|"     This study aims to evaluate favipiravir high dose tolerance in male survivor of Ebola Virus     Disease (EVD) with Ebola Virus (EBOV) RNA in semen. This is a dose escalation study with 3     cohorts of 6 patients, each dose level including 2 sentinel patients.   "
41504|NCT02742363|"     The investigators aim is to explore associations between specific types of cancer therapy,     age at treatment and the presence of dental abnormalities in adolescence.      The study will help identify unique dental changes, malformations and or missing teeth that     appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy     and or radiotherapy) given in childhood.      Materials and methods:        -  Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age          of 0-10 years old.        -  The following data will be collected: Demographic information, Medical Status, Cancer          therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic          examination.   "
41505|NCT02742350|"     Heart surgery procedures are still widely used worldwide for the treatment of patients with     heart problems, and rates of complications in the postoperative period related to them remain     high. In these patients, physical conditioning programs result in improved functional     capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle     training is also emerging as a valuable strategy in the treatment of cardiac patients. The     study of the interaction between cardiac rehabilitation and high intensity IMT about these     changes is not yet understood in this population. The aim of this study is to assess the     effects of inspiratory muscle training high intensity associated with cardiac rehabilitation     exercise performance of patients in the postoperative period of CABG surgery.   "
41581|NCT02741349|"     The aim of the present prospective study is to further develop and validate a composite risk     score predicting both ischemic and bleeding risk, based on epidemiologic, clinical,     biological, and/or morphologic complementary data. First, the investigators will assess the     predictive performance of current clinical risk scores. Second, the investigators will assess     the potential predictive value of additional markers. Third, the investigators will aim to     develop a new risk score.   "
41506|NCT02742337|"     • Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs     (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify     genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis     patients have been inconclusive. Furthermore the presence of epigenetic signatures in     rheumatoid arthritis patients has not been established. This protocol is the first step to     identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or     medication selection in rheumatoid arthritis patients. Subsequent research into such     epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic     signatures (EGS) exist the business need for such tests will thus be supported.   "
41507|NCT02742324|"     Phase 1/2, open-label, multi-center, trial, aiming at to identify the most efficacious dose     combination that also satisfies certain safety requirements. It consists in a dose finding     study to assess the safety of the combination of different doses of both ruxolitinib and     peg-IFN alpha-2a, and a secondary randomized evaluation of the optimal doses found in the     first part of the study to a total maximal number of 42 evaluable patients.   "
41508|NCT02742311|"     In this prospective observational trial the effect of the Endoscopic discectomy microinvasive     therapy should be examined in (approximately 500) adult patients with low back pain.   "
41509|NCT02742298|"     Study Objectives:        1. Determine the correlation between quantitative muscle ultrasound (QMUS), electrical          impedance myography (EIM) and currently accepted measures of physical function.        2. Determine the reliability of EIM measures performed in the home through use of a hand          held device.        3. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.   "
41510|NCT02742285|"     Measurement of the concentration of antimalarials in the blood of the general population     helps estimating the overall drug pressure and is used in efficacy studies. The current     sampling standard for drug measurement is plasma obtained by venous puncture. The use of a     Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions     easier, but concordance with usual venous sampling is not yet established.      The current work will allow validating the concentrations of lumefantrine measured in the DBS     samples collected during the field trials and validate the use of DBS for future studies. In     addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations     supplies throughout most malaria endemic countries, this study may improve our understanding     of lumefantrine and artemether distribution in the blood compartments and generate knowledge     for further developing analytical methods for drug measurement.      The overall purpose of this study is to validate the dried blood spots as a sampling method     for the analysis of lumefantrine.      The primary objective is to assess the concordance between lumefantrine plasma and dried     blood spots (DBS) concentrations.      The investigators also aim at describing lumefantrine's distribution in the different blood     compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total     in whole blood.   "
41511|NCT02742272|"     The purpose of this study is to develop a clinical decision rule for patients seen in the     pediatric emergency department for possible intracranial pathology. This a prospective study     evaluating patients presenting with headache and migraine. The study is observational and     does not impact patient care.   "
41512|NCT02742259|"     The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC)     analysis system will be validated in patients diagnosed with metastatic prostate cancer. It     will demonstrate substantial performance equivalency to a CTC Assay predicate device.   "
41513|NCT02742246|"     Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment     for reducing alcohol use   "
41514|NCT02742233|"     To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients     with diabetic foot ulcers, the investigators randomly divided the participants into two     groups: saxagliptin with regular treatment group，placebo with regular treatment group. The     clinical data are collected at the given time point. This study aimed to observe the     potential protective effect of DPP4i on diabetic ulcers.   "
41515|NCT02742220|"     The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood     pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60     patients which will be randomized into 2 groups (30 per group), IHT and control group (CG).     IHT group will training isometric contraction for 8 weeks. The GC patients will be encouraged     to increase the level of physical activity. In the pre and post-intervention, brachial and     central blood pressure will be measured.   "
41527|NCT02742064|"     The purpose of this study is to determine if a mobile sensing platform can passively and     objectively detect the presence of clinically significant mood disorder symptomatology and     symptom progression over time. Meeting this goal will allow for improved risk categorization,     prediction of relapse, and measurement of disease progression in a lifetime prevalence     population.   "
41516|NCT02742207|"     Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many     patients in order to regain sinus rhythm. In a previous retrospective study a complication of     acute renal failure was found in 17% of the patients after cardioversion.(The incidence and     prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman     Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described     after cardioversion is pulmonary edema.      In this prospective study the investigators aim to evaluate the risk of acute renal failure     post cardioversion. In addition the investigators would like to evaluate hemodynamic changes,     fluid balance and sodium levels in patients post cardioversion as a potential mechanism for     both acute renal failure and pulmonary edema post cardioversion. In order to assess     hemodynamic changes the investigators will use a non-invasive FDA approved device called     NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and     peripheral vascular resistance in a non-invasive, fast and accurate way.   "
41550|NCT02741765|"     This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional     (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor     (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with     Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective,     randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2     Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study     will look at BDNF-TrkB signaling and cortical plasticity.   "
41517|NCT02742194|"     Regarding its complex pathogenesis and clinic-epidemiological meaning, different strategies     are needed for the treatment of obesity. Ginger is the rhizome of a plant with thermogenic     and anti-inflammatory effects, and may be a promising alternative as add-on strategy in the     treatment for obesity. The primary objective of the current study is to assess whether     consumption of ginger as an add-on strategy to restrictive diet is effective to reduce fat     body percentage, increase basal metabolic rate and improve loss weight.      The secondary objectives are:        -  to assess the effect of nutritional intervention in quality of diet and weight loss.        -  to evaluate the effect of ginger on behavioral symptoms and peripheral biomarkers in          overweight subjects.   "
41518|NCT02742181|"     This will be a prospective randomized control trial with a total of 142 patients. Patients     who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy     reversal with small bowel resection that subsequently develop postoperative ileus will be     eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized     at the time of diagnosis of postoperative ileus to receive Entereg as rescue therapy or to     receive conservative standard care.      Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from     the time of randomization until the return of bowel function or 5 days. Both groups will be     treated with conservative standard care, including bowel rest, reduction in oral diet, and     placement of nasogastric tube as clinically indicated.      All patients will follow a standard ERAS pathway after surgery, with early feeding and     ambulation, along with opioid minimizing measures as is our standard postoperative protocol.      Primary outcome will be hospital length of stay. Secondary outcomes will include time to     return of bowel function, 30-day morbidity/mortality, complications, reoperation and     readmission.      Total number of patients: 142 Patients in each study group: 71   "
41519|NCT02742168|"     This is an open-label SPECT/CT (single photon emission computed tomography / computed     tomography) study to investigate clinical study of 99mTc-3PRGD2 SPECT/CT in diagnosis and     efficacy evaluation of breast cancer. Diagnostic group: for patients in suspicion of breast     cancer. The standard of truth for diagnosis was based on histopathologic findings after     surgical removal of the tumor or a definite diagnosis from fine needle aspiration biopsy. A     single dose of nearly 0.3 mCi/kg (milli-Curie/kilogram) body weight of 99mTc-3PRGD2 ( ≤ 20 µg     3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method     will be used to assess the whole-body planar and lesions SPECT/CT images.      Efficacy evaluation group: for patients firstly diagnose with malignant tumors (breast     cancer), and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy. The     standard of truth for diagnosis was based on histopathologic findings after fine needle     aspiration biopsy. A single dose of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg     3PRGD2) will be intravenously injected into the patients before treatment, the second period,     sixth period. Visual,semiquantitative method will be used to assess the whole-body planar and     lesions SPECT/CT images. By comparing with result of the other related imaging, for instance,     PET/CT (positron emission tomography/computed tomography), CT (computed tomography), MRI     (magnetic resonance imaging), Doppler Ultrasound, Mammography, etc.   "
41520|NCT02742155|"     The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on     families of infants with infant sleep disturbances.   "
41521|NCT02742142|"     This study was a randomized clinical trial lasting for 24 months in two study sites, Hong     Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will     be recruited from elderly social centers located in different districts in the two study     sites (260 & 274). Baseline clinical examination was conducted by a single calibrated     examiner in the social centers using an intra-oral LED light, mouth mirrors and probes.     Subjects were randomly allocated into two study groups and receive interventions accordingly.     Follow-up examinations at 6-month intervals were carried out to assess the clinical outcomes,     i.e. whether new root caries developed and whether the active root caries found at baseline     become arrested. Results of this study could provide the much needed evidence to guide the     dental professionals in Hong Kong and China, and possibly worldwide in deciding on the most     appropriate intervention for the prevention and management of this common dental disease of     the older adults.   "
41522|NCT02742129|"     A randomized, double-blind, placebo-controlled crossover study to assess the effect of     inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing.     Approximately 100 participants will be enrolled in this 2*2 crossover study.   "
41523|NCT02742116|"     The objectives are to:        1. Assess patient's views and preferences in receiving expanded carrier screening        2. Perform qualitative study on post testing counselling on screen positive individuals and          at risk couples   "
41524|NCT02742103|"     This study is a phase 2, multicenter, double-blind, randomized, placebo controlled,     parallel-group study to investigate the renal safety and tolerability of multiple dose     intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate     renal impairment (RI) and acute myocardial infarction (AMI).   "
41525|NCT02742090|"     This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a     single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK     inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)   "
41528|NCT02742051|"     This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of     neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus     cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative     breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast     cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by     imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18     weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine     the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with     ER-positive, HER2-negative breast cancer, and to compare the objective response rate.     Secondary aims are to compare the response rate by clinical palpation, pathological complete     response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the     percentages of peripheral blood CD8+ T cells, T helper cells (Th), regulatory T cells (Treg),     and NK cells (pre- versus post- neoadjuvant therapy).   "
41529|NCT02742038|"     Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and     2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic     areas of Chile were invited to participate. Oral health education component was given to     children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child     was delivered to the parents at baseline and in each of the follow-up visits. The     experimental group was treated with fluoride varnish every six months while the control group     received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of Caries     Incident Cases, increment dmft index   "
41530|NCT02742025|"     The main objective of this study is to evaluate the impact on preoperative anxiety of an     education and information program conducted prior to non-urgent coronary angiography     performed in patients hospitalized at the Nîmes University Hospital.   "
41531|NCT02742012|"     The present study is designed to validate an multimodal indicator of anesthetic depth     (Schneider G et al. 2014, Anesthesiology 120, 819-28).      The indicator previously developed shall now be tested on an independent set of data.      The investigators will include 250 patients undergoing general anesthesia in 3 German     tertiary care centers.      The design is strictly observational - the anesthetic regime is at the discretion of the     clinician and will not be influenced.   "
41532|NCT02741999|"     This protocol seeks to enroll smoldering multiple myeloma (SMM) patients with λ light chain     (LC) involvement, a group of patients for whom standard of care is observation not treatment.     Patients with SMM have a precursor plasma cell disorder from which light chain amyloidosis     (AL) often evolves. In this trial they will have blood and bone marrow cells evaluated by     molecular testing to determine their clonal λ LC variable region (VL) germline gene. The     repertoire of clonal germline genes employed in AL is restricted; 70% of cases of AL involve     just 7 germline donors, 5 of which are λ germline donors. The hypothesis that will be tested     with this protocol is that the presence of VL germline genes associated with AL in patients     with a pre-existing diagnosis of λ SMM will be indicative of risk of progression to AL.   "
41533|NCT02741986|"     Brief Summary: The goal of this study is to implement and test an intelligent perioperative     system (IPS) that in real-time predicts risk for postoperative complications using routine     clinical data collected in electronic health records. The accuracy of computer-generated risk     scores will be compared to physician's risk scores for the same patients. Physicians will be     also asked to provide the opinion regarding the computer-generated risk scores using     interactive interface with the program. The information regarding the risk scores performance     will be collected during the two 6-month periods. The accuracy of IPS and physicians will be     compared at the end at those two time periods.   "
41534|NCT02741973|"     The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for     school sports to evaluate potential effects in stress reduction and concomitant psychological     parameters.   "
41535|NCT02741960|"     This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and     safety of add-on metformin to conventional immunosuppressants in systemic lupus erythematosus     (SLE).      The purpose of this study is to evaluate: 1) the effect of metformin on reducing disease     flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of     metformin on body mass index (BMI); 4) the safety of metformin.   "
41536|NCT02741947|"     The trial was an experimental two-centers, randomized, double-blind, two-sequence,     non-inferiority cross-over study.      Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to     participate in the study entered a 4 weeks period if not on stable regimen of Madopar®     (run-in period). Following the run-in period, there were two maintenance periods of 4 weeks     each, for a total duration of 8 weeks.      Patients were assigned randomly (1:1) by a computerized randomization system to one of two     formulation sequences maintaining the dose stabilized during the run in:        -  generic-originator        -  originator-generic At the end of maintenance period 1, the patients in each formulation          group underwent an overnight switch to the same dose of the alternative formulation. The          dose was kept stable during the whole length of trial. Clinical evaluations were          performed at the end of each period. The tablets were encapsulated to maintain the          blindness.      A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14     subjects.      Population: out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5     years, receiving L-dopa/benserazide.      The total duration of the trial was approximately 8 weeks for patient divided in two     maintenance periods of 4 weeks each.   "
41537|NCT02741934|"     This study evaluates the cognitive and behavioral outcomes including image findings of     school-aged children who were born preterm compared with who were born term gestational age.   "
41538|NCT02741921|"     The investigators sought to compare the time to intubation and success rate of the     endotracheal intubation using standard double-lumen tube and video tube ETView DL in an adult     cadaver model in normal and difficult airway conditions.   "
41726|NCT02739464|"     This study will measure efficacy of early in-patient exercise as an adjunct to current     Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to     assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10)     carried out soon after admission until hospital discharge (including during the BICU stay and     time on ventilation).   "
41549|NCT02741778|"     Of the esophagogastric junction adenocarcinoma (AEG) is a 5 cm region of adenocarcinoma of     the esophagus and stomach. Due to the special anatomical location, the biological behavior of     esophageal cancer and gastric cancer are not the same. For the resection of esophageal     gastric junction adenocarcinoma, the main treatment method for the treatment of surgical     treatment.      For the type II type of esophageal gastric junction adenocarcinoma, the mainstream of the     traditional surgical approach for the left chest to open the chest, for the lesions of the     small type of esophageal gastric junction adenocarcinoma can be performed minimally invasive     Ivor-Lewis esophageal resection.      There is no reasonable standard for treatment of type II type esophageal gastric junction     adenocarcinoma. The investigators sum up the experience of the past in the minimally invasive     resection of esophageal cancer, and combine domestic and foreign research results. Pioneered     by laparoscopic mobilization of the stomach and dissection of the abdominal field lymph node     + thoracoscopic (left thoracic approach) to free the esophagus and cleaning + mirror under     the purse string forceps esophagogastric aortic arch anastomosis under lower mediastinal     lymph node, corresponding to the operation is the traditional through left thoracotomy     combined with open operation on diaphragm. Can achieve the same with the traditional surgical     resection of the tumor, while taking into account the characteristics of minimally invasive     surgery. This study intends to provide a minimally invasive surgical treatment of the chest     laparoscopy combined with minimally invasive surgery and traditional thoracotomy. Comparison     of different surgical methods for patients with the safety of surgery, oncology resection     range, the incidence of short-term complications. The effect of different surgical methods on     the survival rate and quality of life of the two groups were compared with the postoperative     follow-up. The surgical treatment of esophageal carcinoma with a reasonable level of type II     type of esophageal gastric junction adenocarcinoma is improved, and the surgical treatment of     esophageal gastric junction adenocarcinoma is improved.   "
41539|NCT02741908|"     Obesity is a chronic illness and multifactorial etiology, related to genetic factors,     environmental and behavioral. Features association with several metabolic abnormalities in     childhood, leading to increased risk of cardiovascular disease in adult life. The treatment     involves lifestyle change, with balanced diet guidance and encouraging physical activity. The     treatment in this age group have brought limited data, in addition to high drop-out rates. A     unique type of food guidance is the equivalent calorie count, where calories are converted     into points. The objective of this study was to evaluate the variance of Z score of body mass     index (ZIMC) of obese adolescents undergoing orientation of two groups of low-calorie diet:     traditional and based on the points system, as well as evaluate anthropometric variables,     body composition, food intake, metabolic changes and self-monitoring.      METHODS: randomized clinical study with duration of 24 weeks, with 66 adolescents with an     average age of 13.7 ± 0.7 years of both genders, with scores of BMI >= 2 to <= 4 curve     adjusted for gender and age of the World Health Organization. Were verified weight, height,     blood pressure and waist circumference, intensity of physical activity and self- monitoring,     as well as performed the nutritional guidance to each visit. Laboratory parameters, applying     the scale of binge eating, pubertal, stage and body composition were evaluated at the     beginning and end of the action. The patients were divided into two groups: one that received     guidance of traditional low-calorie diet and meet the food consumption record (RCA), three     days (Group A) and another that received low-calorie diet guidance based on the system of     points and meet the daily RCA (Group B).   "
41540|NCT02741895|"     This study will evaluate whether information on postoperative ambulation from Fitbits can     improve surgeons' ability to monitor ambulation and identify patients at risk for prolonged     length of stay, 30-day readmissions, and discharge to transitional care after major surgery.   "
41541|NCT02741882|"     It is suspected that zika virus infection during pregnancy is associated with microcephaly.     The objective of this study is to investigate the occurrence of rash accompanied by three or     more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the     case-control design.   "
41542|NCT02741869|"     The purpose of the study is to evaluate whether PDT (MRSAid™) is effective in eradicating SA     from hemodialysis patients who are known to harbor this organism inside their nose.   "
41543|NCT02741856|"     Research has shown that increasing the dose of radiotherapy improves outcomes in patients     with lung and head and neck cancers. This study aims to see whether this is also the case for     patients with tumour of the oesophagus. This trial will compare the effects of the standard     dose of radiotherapy to a higher dose whilst closely monitoring the side effects.      A comparison will also be made regarding the effects of the standard drugs used in     chemotherapy (cisplatin and capecitabine) with an alternative combination (carboplatin and     paclitaxel) in patients that do not show a response to chemotherapy with standard drugs early     on in treatment.      All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy.      How the study will be conducted:      Prior to the commencement of treatment each patient will have a special scan called a PET     scan. Patients will receive a second PET scan two weeks after the start of standard     chemotherapy. The changes between the two scans will then be used to allocate treatment into     the different arms of the study. All study subjects will be randomised to receive either the     standard radiotherapy dose or the high radiotherapy dose. The participants that do not     respond to the first cycle of standard chemotherapy will be eligible to take part in the     aspect of the trial looking at an alternative chemotherapy regimen. Patients will be     randomised as follows;      On the basis of the second PET scan, patients who are not responding to standard chemotherapy     will be allocated by a computer to one of the four groups detailed below:        -  Standard chemotherapy and standard dose of radiotherapy        -  Standard chemotherapy and higher dose of radiotherapy        -  Alternative chemotherapy and standard dose of radiotherapy        -  Alternative chemotherapy and higher dose of radiotherapy      Patients who are responding to standard chemotherapy (or where the response is unknown or     those who were not eligible for PET scan portion of the study) will be allocated by a     computer to one of two groups detailed below:        -  Standard chemotherapy and standard dose of radiotherapy        -  Standard chemotherapy and higher dose of radiotherapy      The arms within each of the groups above (responders and non-responders) will be equal in     size and patients will be allocated randomly by a computer.      This study will also compare the way that this treatment affects the two different cell types     found in oesophageal tumours.      The effects of the different treatment, together with the costs of the different treatment     and the effects on quality of life will be analysed to see which is more effective for each     of the different groups.   "
41544|NCT02741843|"     The purpose of this study is to test the effectiveness of brief face-to-face patient     education in increasing uptake of influenza vaccine among Chinese elderly in the community.   "
41545|NCT02741830|"     This cross sectional, two cohort study seeks to investigate both anatomic outcome and     subjective, functional outcome of uterosacral ligament suspension versus robotic     sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and     complication rate for each procedure.This study will provide a better understanding about the     durability of these procedures and long term complication.   "
41546|NCT02741817|"     The study is going to compare two different doses of aspirin for the treatment of heart     disease in combination with the anticlotting medication ticagrelor. One of these doses of     aspirin, 75 milligrams (mg) once a day, is the current standard treatment dose of aspirin     used to treat heart attacks and angina. The other, 20 mg twice a day, is lower than the     standard but there is growing scientific evidence that, when given with ticagrelor, this     might offer advantages over the usual dose.   "
41547|NCT02741804|"     The purpose of the Lifestyle Intervention Study is to investigate the influence of a     micronutrient supplement in combination with a comprehensive lifestyle intervention program     on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Patients will be     placed on supplement or placebo throughout their 18-month study participation. Patients will     also be given lifestyle training on nutrition, physical activity, cognitive and social     activity, meditation and sleep, which have all been proven to positively affect cognition     over time. Throughout their participation, patients' cognitive functioning will be monitored     with comprehensive imaging, neuropsychological testing, blood testing and study compliance.   "
41548|NCT02741791|"     To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with     treatment resistant major depressive disorder (MDD).      This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting     of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is     being conducted in subjects with treatment resistant MDD.      Subjects will be considered to have treatment resistant MDD if they have had a historical     inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response     to treatment with bupropion during the open-label, lead-in period.   "
41560|NCT02741622|"     Acute aerobic exercise improves affective stats in patients with mental illnesses. Brain     derived neurotropic factor (BDNF) may be a biological mechanism that contributes to the     affective benefits. The magnitude of the increase of serum BDNF might be exercise intensity     dependent, but no study has compared low high-aerobic-intensity training at 90-95 % of the     maximal heart rate (HRmax) with long-slow-distance training at 70 % of the HRmax in patients     with depression.      The aim of this study is to compare changes in serum BDNF levels after high-aerobic-intensity     training and long-slow-distance training in a intra-individual design in patients suffering     from depression. The results will give indications of a possible difference in BDNF response     between aerobic intensities and may be uses as pilot data for calculating sample size.   "
41554|NCT02741713|"     The standard practice for arthroscopic shoulder surgery at our institution is a general     anesthetic with a long-acting interscalene block for post-operative pain control, which can     reduce the amount of opiates needed after surgery. The interscalene block is effective in     providing analgesia to the majority of the shoulder joint and has been shown to reduce     post-operative pain scores after arthroscopic shoulder surgeries. However, there is a subset     of arthroscopic shoulder surgery patients who have pain in the axilla even in the setting of     a functioning interscalene brachial plexus nerve block. One of our surgeons has reported a     high incidence of axillary pain in patients who undergo a sub-pectoral biceps tenodesis as     part of their arthroscopic procedure. A newly described nerve block approach to the nerves     that supply sensation to the axillary region called the PECS Pectoralis 1 & 2 block may     provide additional analgesia to these patients.      The purpose of this prospective, randomized, observer and patient blinded, single-center,     sham block trial is to determine if the addition of PECS blocks to an interscalene block will     reduce the severity of axillary pain following arthroscopic shoulder surgery that involves a     sub-pectoral biceps tenodesis. Secondarily, the study will assess the duration of PECS 1 & 2     and whether the block reduces post-operative opioid usage. We hypothesize that the addition     of the PECS 1 & 2 block will reduce the severity of axillary pain at 6hrs and reduce     postoperative narcotic usage for the first 24 hours.   "
41555|NCT02741700|"     The objective is to test the efficacy of a patient-centered, culturally relevant narrative     intervention, or storytelling, based on the solid conceptual foundation of the narrative     communication theory and the constructs of the Health Belief Model (HBM) to improve     medication adherence and outcomes in chronic diseases among African-Americans (AA), using     gout as an example. Gout is a chronic disease associated with chronic symptoms and disability     interrupted by intermittent acute flares, similar to Chronic Obstructive Pulmonary Disease     (COPD) and Congestive Heart Failure (CHF) that leads to joint destruction if not treated     appropriately. Due to the intermittently symptomatic nature of chronic conditions, patients     often don't perceive disease severity and susceptibility to disease complications, and,     therefore, may not balance the barriers and benefits to medication adherence. Storytelling in     the patients' own voices has the power to directly and more effectively confront a patient's     barriers to medication adherence, reinforce the benefits and provide useful cues to action.     Storytelling promotes patient engagement when the patient identifies with the storyteller and     can lead to a patient's recognition of the need to treat the condition and improve health     outcomes, as shown by a meaningful improvement in blood pressure in a recent clinical trial     in AAs with hypertension. The success of this project, combined with other published data,     will represent a major step toward demonstrating the effectiveness of storytelling to improve     medication adherence in chronic diseases and will address two VA research priority areas,     i.e., health care disparities and health care delivery.   "
41556|NCT02741687|"     The purpose of this study is to compare sitagliptin with a placebo for the prevention of high     glucose after general surgery.   "
41557|NCT02741674|"     The main goal of this research project is to conduct a comparative effectiveness research     study involving existing data in the PCORnet Common Data Model to provide accurate estimates     of the 1-, 3-, and 5-year benefits and risks of the three most common bariatric procedures -     Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy - with a focus     on outcomes that are important to adults and adolescents with severe obesity: 1) changes in     weight, 2) rates of remission and relapse of diabetes, and 3) major adverse events.   "
41558|NCT02741661|"     This study is a retrospective analysis where coronary arteriograms are being analyzed to     determine whether the presence of tortuous coronary arteries correlate with any specific     measures of left ventricular mass or left ventricular function on echocardiography.   "
41559|NCT02741648|"     The purpose of this trial is to study the effect that anemia and Red Blood Cell (RBC)     transfusions have on oxygen levels in the digestive tracts of Extremely Low Birth Weight     (ELBW) infants and to look for possible markers in a baby's blood, urine and/or stool that     may lead to a better understanding of what makes an ELBW infant at risk for digestive tract     problems such as necrotizing enterocolitis.   "
41561|NCT02741609|"     This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing     Borrelia spirochetes from human serum in subjects with early or late Lyme disease.      This is an 8 month study. Subjects entering the study will have two blood samples collected     one month apart if they have early Lyme disease and one blood sample collected if they have     late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and     exclusion criteria will be entered into the study. Subjects will be assigned a subject number     upon entry and this number will be retained throughout the study.   "
41562|NCT02741596|"     This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in     preventing acute angioedema attacks in patients with Type I and Type II HAE.   "
41563|NCT02741583|"     prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma     rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and     asthma control.   "
41564|NCT02741570|"     The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study     regimen as first line treatment in patients with recurrent or metastatic squamous cell of the     head and neck cancer   "
41596|NCT02741154|"     study the effect of aromataze inhibitor induction together with short stimulation protocol by     gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before     ICSI   "
41597|NCT02741141|"     In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was     21 % and 16% to 38% in case of dystocia.      The definition of  dystocia  is traditionally based on the research led by Friedman in the     1950's on a restricted population sample. Several studies over the last years seem to     indicate that the different phases of labour are longer than originally described by     Friedman.      Our current hypothesis is that the application of a new definition of dystocia would enable a     more appropriate management of labour.   "
41644|NCT02740530|"     This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS),     known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility,     particularly gait stability and variability, and executive dysfunction in older adults. The     study will be conducted in forty older adults (≥60 years) with a diagnosis of executive     dysfunction.   "
41565|NCT02741557|"     The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination     (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25 mg     versus co-administration of the separate tablet formulations of DTG 50 mg plus RPV 25 mg, in     the fed state. This pivotal bioequivalence study, is to serve as a pharmacokinetic (PK)     bridge to the ongoing Phase 3 trials with the separate agents. This study will be conducted     under fed conditions to appropriately mimic the conditions in the Phase 3 trials. This is a     single-center, randomized, open-label, 2-period, single-dose, crossover study. A minimum of     86 healthy adult subjects will be randomized such that a minimum of approximately 82     evaluable subjects complete the study. The total duration of participation of a subject in     this study will be approximately 8 weeks which includes a screening visit within 30 days     prior to the first dose of study drug, two treatment periods each with a single dose of study     drug and a follow-up visit within 12-17 days after the last dose of study drug. There will be     a washout of at least 21 days between each dose of study drug.      A blinded (for treatment) review of DTG and RPV plasma concentration data for approximately     the first 40 subjects will be conducted. If the within-subject coefficients of variation     (CVw%) for either DTG or RPV maximal drug concentration (Cmax) values are >=31%; a sample     size re-estimation will be employed and additional subjects (beyond the 86 planned) will be     randomized for treatment in the study. Following the re-estimation, it is possible that up to     approximately 154 healthy adult subjects (68 new subjects in addition to the planned 86     subjects above) will be randomized such that a maximum of approximately 146 evaluable     subjects could complete the study.   "
41566|NCT02741544|"     To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter     referred to as Revlimid) in all patients who are treated with it under the actual condition     of use pursuant to the conditions of approval.        1. Planned registration period This period started on the date of initial marketing of          Revlimid and will end at the time when the planned number of patients to be enrolled is          reached.        2. Planned surveillance period This period started on the date of initial marketing of          Revlimid and will end on the day when the approval condition related to all-case          surveillance is terminated.   "
41567|NCT02741531|"     The purpose of this study is to determine if partially filling the bladder after     laparoscopic/robotic gynecologic surgery (for benign disease) shortens the time required to     spontaneously void for patients to determine if this subsequently shortens patient stay times     in the Post Anesthesia Care Unit (PACU) following surgery. This intervention would be     compared to the current standard of care, which involves removing the patient's Foley     catheter with an empty bladder and then giving the patient up to 6 hours to void in the PACU.   "
41568|NCT02741518|"     This is a randomized controlled pilot study to assess the microbiological and clinical     impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators     will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or     higher) after providing written informed consent. The study participants will be randomized     1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an     induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12     weeks total. The placebo group will receive a placebo capsules for induction followed by     monthly intake of oral placebo capsules for 12 weeks.   "
41569|NCT02741505|"     The primary purpose of this study is to explore the underlying mechanisms that link sleep to     Alzheimer's disease (AD), with special focus on the clearance of metabolites in the     extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to     determine regular daytime activity and sleep patterns. Subjects will then undergo partial     sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG).     Participants will be be asked to stay awake and active all day after the partial sleep     deprivation with a new actigraphy secured by a hospital band to assure participants remain     awake. They will seep inside an MRI machine for 90 minutes on the following night during     their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow     imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.   "
41570|NCT02741492|"     This study is designed to evaluate pain control of continuous transversus abdominis plane     (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that there     will be improved pain control when compared with sham blocks.   "
41571|NCT02741479|"     The purpose of this research is to determine if a specific type of elasticated athletic tape     (Kinesio Tex Tape) increases muscle activation among professional level dancers.     Investigators will determine if changes in muscle activation with the elasticated tape differ     from changes experienced with no tape and/or sham tape, and if it coincides with subjective     sense of muscle activation.   "
41572|NCT02741466|"     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.   "
41801|NCT02738489|"     This is an open-label, single center, non-randomized, dose escalation phase I trial to     evaluate safety and tolerability of SHR-1210 in patients with advanced Melanoma. The primary     objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II     doses of SHR-1210 in patients with advanced Melanoma.   "
41573|NCT02741453|"     Central venous catheter placement is a common procedure in the intensive care unit and is a     required skill for all residents working in the critical care setting. Central venous     catheters (CVC) are placed for a variety of reasons including administration of caustic     medications, administration of fluids or blood products for rapid resuscitation, access for     hemodynamic monitoring or transvenous pacing, temporary vascular access for dialysis, or     inability to obtain peripheral IV access. CVC's are routinely placed in the internal jugular     vein in the Vanderbilt medical ICU and ultrasound guidance is used. Placement of the CVC on     the right IJ instead of the left IJ is commonly preferred due to the more direct path to the     superior vena cava. However, placement in the left IJ may be necessary for a variety of     reasons. The investigators intend to compare the standard practice of residents and nurse     practitioners placing IJ CVCs in the medical ICU against mandatory screening of the right and     left IJ prior to selection of the CVC placement site. The investigators will accomplish this     by assessing the relative first pass stick and overall success rates, the rate of aborted     procedures, and the rate of complications between standard practice and mandatory screening     of bilateral internal jugular veins prior to CVC site selection.   "
41574|NCT02741440|"     Background:      Spinocerebellar ataxia type 7 (SCA7) is disease in which people have problems with     coordination, balance, speech and vision. It is caused by a change in the ATXN7 gene. A     mutation in this ATXN7 gene causes changes in eye cells, which can lead to vision loss. There     is no cure for SCA7 but researchers are looking for possible treatments. Researchers need     more information about SCA7. They want to collect vision and neurology related data from     people with SCA7. They want to learn how and what changes in the eye and brain when the ATXN7     gene isn t working properly.      Objective:      To learn more about SCA7 and its progression.      Eligibility:      People ages 12 and older with SCA7.      Design:      Participants will be screened with medical history and genetic testing from a previous     National Eye Institute study or their personal physician.      Participants will have at least 7 visits over 5 years. They will have 2 visits during the     first week of the study. Then they will be asked to come back every year for the next 5     years. Each visit will last several days and will include:        -  Medical and eye history        -  Several eye tests: some will include dilating the pupil with eye drops and taking photos          or scans of the eyes.        -  Electroretinography (ERG): Participants will sit in the dark with their eyes patched for          30 minutes. After this, the patches will be removed and contact lenses put into the          eyes. They will watch flashing lights and information will be recorded.        -  Neurological exams: Sensation, strength, coordination, reflexes, attention, memory,          language, and other cognitive functions will be tested.        -  Brain MRI: They will lie in a machine that takes pictures of the brain.        -  Blood and urine tests        -  Optional skin biopsy: About 3 millimeters of skin will be removed for more research          testing; this is half the size of a pencil eraser.   "
41575|NCT02741427|"     The purpose of this study was to compare the whitening effect of a toothpaste containing blue     pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the     subject's perception about tooth color improvement and; and evaluate the safety and     acceptability of these products.   "
41576|NCT02741414|"     Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even     falls into an unacceptable range. A major cause of treatment failure is associated with     antibiotic resistance and poor patient compliance. However, the refractory infection of H.     pylori is still existing, although patients have good compliance and receive standardized     treatment. This phenomenon is likely attributed to the different ratio of sensitive and     resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in     vitro, the difference between phenotype and genotype or the influence of micro-environment in     the stomach. In order to solve the refractory infection of H. pylori, investigators performed     a muti-center study together with other 14 institutions. In this study, investigators will     select the patients with refractory infection of H. pylori after two standardized treatment     from patients with first eradication therapy of H. pylori infection. Then, investigators will     perform a high-throughput sequencing for patients in groups. Finally, investigators will     compare the differences between the patients with first successful eradication and patients     with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and     genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.   "
41577|NCT02741401|"     The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a     prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical     Centre located Sittard-Geleen, The Netherlands concerning patients who underwent surgery for     gastrointestinal malignancy. During 5 consecutive days, the intervention group received     postoperatively hand-foot massage administered by trained volunteers.      The aim of this study is to investigate the effect of complementary therapies concerning     quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who     underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).   "
41578|NCT02741388|"     This is an open label, multicenter, dose escalation, phase Ib study to determine the     recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and     preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell     malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation     phase will be followed by an exploratory expansion phase in the same population with 12     patients enrolled in each group, who will receive selinexor at the RP2D.      The 3+3 design will be applied for dose escalation. The escalation will be performed     independently in two distinct groups:        -  Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles)        -  Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles)      The choice of the conventional immunotherapy regimen which will be administered to each     patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before     patient's inclusion. Different dose levels for selinexor administration will be examined     sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per     3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg     flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing     weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will     continue until the MTD is exceeded or until the highest dose level defined in the study (DL3)     is reached.      Dose escalation to the next planned dose level will be decided by the DEC based on the number     of DLTs observed during the DLT assessment period.      The dose escalation phase will be followed by an exploratory expansion phase in the same two     groups (Groups A and B), depending on the decision of the Independent Data Monitoring     Committee (IDMC) after review of safety data at the end of dose escalation part.      Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the     IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the     investigator's choice).   "
41579|NCT02741375|"     Aim: To investigate the efficacy of cerebral oximetry (CO) as an auxiliary diagnostic tool in     confirming brain death (BD).      Materials and Methods: This observational and interventional study was performed on patients     with suspected BD in emergency departments and intensive care units. CO monitoring was     performed for at least 6 h, and cerebral tissue oxygen saturation (ScO2) was recorded. Basal     ScO2 values (basal ScO2), ScO2 values after 6 h (end ScO2), mean ScO2 values during     monitoring (mean ScO2), and minimum (min ScO2) and maximum (max ScO2) ScO2 values observed     during monitoring were recorded for all patients. Patients with diagnosis of BD confirmed by     the organ transplantation and brain death committee were enrolled as the BD group and other     patients as the non-BD group, and cerebral oxygen parameters were compared.   "
41580|NCT02741362|"     This is a Phase I-II open- label single-dose study in subjects with significant refractory     Rheumatoid Arthritis (RA), relapsing Systemic Lupus Erythematosus (SLE) or Sharp's Syndrome     (SS).      This study will enroll a minimum of 20 subjects for RA, 20 subjects for SLE and 20 patients     for SS. 6 week data of serum Tumor Necrosis Factor- alpha (TNFa), Interleukin- 6 (IL-6), C-     Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Cluster of Differentiation     (CD)4 +CD25 + Forkhead box P3(Foxp3) + regulatory T cells, Disease Activity Score for 28     joints (DAS-28) score and pain score will be collected in all patients who are enrolled in     the study for the RA group (Baseline and 6 weeks after). For the SLE group, Transforming     Growth Factor- beta (TGF-β), TNFa, IL-6, Interleukin- 17 (IL-17), CD3+CD8-IL17A+ T helper-17     (Th17) cells, CD4+CD25+Foxp3+ regulatory T cells and the Systemic Lupus Erythematosus Quality     of Life Questionnaire (SLEQoL) score will be collected in all the subjects of this group. SS     group will undergo the assessments of RA and SLE. Prior to the stem cell treatment, the     patient will be assessed for 6 weeks by all the previously mentioned markers. Then, patients     will receive the infusion of stromal vascular fraction cells containing the adult adipose     derived stem cells 'aADSC' (single intravenous dose). The disease- modifying anti-rheumatic     drugs (DMARDs) or the standard SLE treatment will not be interrupted with the exception of     systemic steroids (excluding minimal maintenance dose of one steroid) during the duration of     the study. Follow up visits will take place at 6 weeks, 3 Months and 6 Months after the cell     infusion. Safety will be monitored on an ongoing basis, and an interim safety review will be     conducted by the Investigator(s) and Sponsor after the first 10 patients have been enrolled     and treated in each group.   "
41582|NCT02741336|"     Insomnia is a highly prevalent, often debilitating, and economically burdensome condition.     Reviews of the literature indicate that there are ethnic differences in sleep behavior, with     African Americans objectively and subjectively reporting more disordered sleep than Caucasian     Americans.Chronic insomnia can have a significant impact on mental and physical health     outcomes and has been associated with impaired cognitive performance, particularly, in areas     of speed, attention, working memory, and executive function. In order to understand the brain     mechanisms in sleep disorder both during resting state as well as during cognitive     processing, the investigators will assess resting state EEG (during eyes-closed and eyes-open     conditions) as well as ERP tasks for assessing decision-making and reward processing. The     primary objective of the study is to evaluate the effect of a tailored, telephone-delivered     cognitive behavioral intervention, versus a self- monitoring control condition, on symptoms     of insomnia and its neurodynamic correlates.      Hypotheses: Among Blacks subjectively reporting symptoms of insomnia, those randomized to the     tailored, telephone-delivered CBT-I, compared with those randomized to the self-monitoring     control group, will have: Hyp. 1: Greater reduction in symptoms of insomnia as measured by     the Pittsburgh Sleep Quality Index. Hyp. 2: Greater neurophysiologic improvement (ERP, ERO)     in the intervention condition in response to laboratory paradigms Hyp 3: Greater improvement     in psychosocial functioning including reduction in depression and increase in quality of     life.   "
41583|NCT02741323|"     Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate     the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.   "
41584|NCT02741310|"     Single center, parallel-group, double-blind, placebo-controlled concomitant therapy study in     healthy subjects   "
41585|NCT02741297|"     The primary objective of this study is to characterize the real-world outcomes of spinal cord     stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the     trunk, including unilateral or bilateral pain associated with the following: failed back     surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION     Spinal Cord Stimulator System with MultiWave Technology.   "
41586|NCT02741284|"     Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is     common practice on Labor and Delivery units in the United States. Despite the broad use of     oxygen, it is unclear if this practice is beneficial for the fetus. The purpose of this study     is to compare oxygen to room air in patients with Category II fetal heart tracings with     regard to neonatal acid-base status, subsequent tracings, and production of reactive oxygen     species   "
41587|NCT02741271|"     This study will compare the efficacy and safety of mometasone furoate/formoterol fumarate     (MF/F) 100/10 mcg to mometasone furoate (MF) 100 mcg, both administered twice daily (BID) by     metered-dose inhaler (MDI), in 5- to 11-year-old children with persistent asthma. This study     will evaluate the change in forced expiratory volume in one second (FEV1) from baseline as a     measure of pulmonary function   "
41588|NCT02741258|"     This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity     due to radiotherapy in patients with post-surgery breast cancer.      Mepitel film will be placed on the skin of the patients just before the start of the     radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of     skin toxicities mepitel film will be placed until resolution of toxicities.   "
41589|NCT02741245|"     This study will evaluate the efficacy and safety and tolerability of 2 dose levels of     MK-0653H in Japanese participants. The primary hypotheses are that the administration of     MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe     and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol     (LDL-C) after 12 weeks of treatment.   "
41590|NCT02741232|"     In this study, the investigators will compare the intraoperative opioid consumption for     patients undergoing breast cancer surgery. The patients will be divided in two groups, the     first one will receive a pectoral nerve block right after induction of anesthesia and the     second one, the control group, will not receive the pectoral block. Our hypothesis is that     the pectoral nerve block reduces the opioid consumption during the surgery.   "
41591|NCT02741219|"     The purpose of this multicenter study is to evaluate the effectiveness and safety of     dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean     section   "
41592|NCT02741206|"     This is randomized control trial of a brief intervention called Bellevue ROSE (Reach Out Stay     Strong Essentials). Bellevue ROSE is a manualized and highly structured interpersonal     intervention that provides women with psycho-education about maternal depression and     strategies for strengthening social support and connectedness. Investigators use motivational     interviewing strategies to improve treatment compliance and resource acquisition   "
41593|NCT02741193|"     The aim of the study is to examine the degree of concordance between presurgical     neuronavigation guided TMS (nTMS) and direct cortical stimulation (DCS) in identifying hand     motor cortex in adults undergoing epilepsy surgery.      Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation     will be delivered to hand primary motor cortex, with positive and negative functional sites     determined through surface electromyography (EMG).      The study will involve patients ages 12-60 years, with planned neurosurgery involving     implantation of intracranial subdural electrodes including over the precentral gyrus.      Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation     will be delivered to hand primary motor cortex, with positive and negative functional sites     determined through surface electromyography (EMG).      The primary outcome measure will be spatial correlation between topographic maps of hand     motor representation obtained through nTMS compared to direct, extra-operative cortical     stimulation performed as part of routine clinical care. A secondary outcome measure will be     safety and tolerability of TMS in the epilepsy patients.   "
41594|NCT02741180|"     The primary purpose of this study is to improve the quality of Magnetic Resonance Imaging in     patients with heart arrhythmia. Investigators will recruit 105 patients with arrhythmia and     30 control volunteers over 3 years and will use two arrhythmia-tolerant imaging methods for     diagnosis.   "
41595|NCT02741167|"     The purpose of this study is to assess the dynamics of inflammatory parameters in presence or     absence of infectious complications after cytoreductive surgery with hyperthermic     intraperitoneal chemotherapy.   "
41598|NCT02741128|"     The aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a     population of special interest, such as HIV-positive adults.      Primary Objective:        -  To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults.      Secondary Objectives:        -  To describe the humoral immune response to each dengue serotype at baseline and after          each injection of CYD dengue vaccine in HIV-positive adults.        -  To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults.        -  To describe changes in CD4 count and HIV RNA viral load after each injection of CYD          dengue vaccine in HIV-positive adults.      Observational Objective:        -  To describe the FV (YF, Dengue) serological status in the study population at baseline.   "
41599|NCT02741115|"     This study will evaluate the clinical efficacy and safety of udenafil, an orally     administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of     adolescent subjects who have undergone the Fontan procedure.   "
41600|NCT02741102|"     This study will examine the feasibility of initiating a uterine transplant program for     Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators     plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients)     After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation,     Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of     follow-up is planned.   "
41601|NCT02741089|"     This monocentric, non-interventional observational registry study was designed in order to     obtain data of patients with the indication for a flexible bronchoscopy to control and     optimize a guideline conform therapy of these patients.   "
41603|NCT02741063|"     to investigate whether oxytocin alter attentional bias towards emotional expression faces in     individuals with high and low autistic traits, and the brain mechanism of this effect   "
41604|NCT02741050|"     The goal of this proposal is to test the efficacy of a primary care-delivered, print-based     physical activity intervention for Latinas with type II diabetes. The investigators will test     the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited     through UCSD Health System primary care to either the adapted web-based physical activity     intervention or standard of care, and assessing physical activity gains at six and 12 months.     The ultimate goal is to develop a print-based physical activity intervention for diabetic     Latinas that could be widely disseminated through primary care.   "
41605|NCT02741037|"     Mexican American women have significantly elevated rates of obesity and type 2 diabetes. The     proposed study tests a novel intervention that capitalizes on an existing important family     dyad (mothers and their adult daughters) to foster clinically significant and long-lasting     health behavior change. If found to effective, this intervention strategy has great potential     to address health disparities in this, and other, at-risk populations.   "
41619|NCT02740855|"     During the ethanol sclerotherapy procedure, the investigators will record doses of and time     of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes.     Furthermore after every ethanol injection the concentration will be measured every minute for     5 minutes. To do so, the investigators will attach a breath alcohol testing device to the     expiratory carbon dioxide measuring unit. Since this is the new standard of the university     hospital Berne all patients undergo the same procedure. There is no study specific     intervention. In this study the investigators will only document the breath alcohol levels,     doses and timing of ethanol injections. All other data will be obtained from the anesthesia     information system. During the two months of the study, the investigators will also record     endtidal ethanol concentration after anesthesia in the postoperative care unit discharge from     the unit.      The intention is to show the correlation between injected ethanol doses and measured endtidal     ethanol concentration over the entire time of the intervention.   "
41606|NCT02741024|"     This will be an open-randomised non-inferiority study to test the hypothesis that the risk of     recurrent parasitaemia after 42 days is not worse in the group receiving the     Artesunate-Amodiaquine (ASAQ) regimen than in the group receiving the Artemether-Lumefantrine     (Coartem®) regimen. Children with uncomplicated malaria meeting the inclusion criteria will     be enrolled (after their parent/caretaker has given informed consent), treated on site with     the drugs under evaluation and followed-up for a period of 42 days. Drugs will be given under     direct supervision, either at the clinic or at home. Follow-up shall consist of a fixed     schedule of clinical and laboratory examinations. Based on clinical and laboratory findings,     children will be classified as therapeutic failures (early or late) or adequate responders.      The proportion of cases experiencing an in vivo therapeutic failure during the follow-up     period will provide an estimate of the efficacy of the drug regimens. A Polymerase Chain     Reaction (PCR) analysis will be carried out to differentiate true recrudescence due to     treatment failure from episodes of re-infection. This proposal is compliant with the latest     WHO recommendations for anti-malarial efficacy monitoring in high, medium or low transmission     zones11.   "
41607|NCT02741011|"     Aim of this study is to evaluate the necessity of the radiological examinations of mentally     handicapped or uncooperative patients.   "
41608|NCT02740998|"     Despite many years of research, controversy persists as to whether hormonal contraception     promotes HIV acquisition. A number of observational studies on depot medroxyprogesterone     acetate (DMPA) injection showed an increase in HIV risk and no evidence of increased risk     with oral contraceptive pills. There are no human studies currently published on the impact     of the levonorgestrel intrauterine device (LNG IUD) on HIV transmission risk and minimal data     on the effects of the etonogestrel subdermal implant (ESI) on risk of HIV acquisition.     Establishing whether any of these highly effective contraceptives increases the risk of HIV     infection would have far-reaching public health implications, particularly in areas of high     HIV prevalence such as sub-Saharan Africa, where injectable contraception accounts for nearly     half of contraceptive use.      Perturbations in the normal vaginal microbiota, or community of microorganisms inhabiting the     vaginal body niche, have long been known to affect the risk of transmission of HIV. Studies     have shown altered vaginal microbiota with DMPA injection and preserved vaginal microbiota     with the LNG IUD, but no studies have compared these methods head-to-head or used     culture-independent sequencing methodology. The investigators propose a prospective pilot     study to evaluate the impact of different long-acting progestin contraceptive formulations on     the vaginal microbiome. Specifically, the investigators aim to identify and compare     metagenomics profiles associated with DMPA, LNG IUD, and ESI contraceptive use by community     analysis of vaginal swab samples from women collected longitudinally after contraceptive     method initiation. The investigators hypothesize that DMPA will increase community diversity     in the vaginal microbiota, whereas the LNG IUD and ESI will not affect the balance of     microorganisms in the vagina. Women who are planning to initiate DMPA, LNG IUD, and ESI     contraception as well as controls not seeking contraception will be recruited for the study     from Boston Medical Center (BMC), a tertiary care center with a racially and     socioeconomically diverse patient population. Women will have longitudinal follow-up with     self-sampling of the vagina for sexually transmitted infection testing and metagenomics     analysis at method initiation, 2-3 months, and 6 months. Establishing the safest long-acting     progestin contraceptive alternative will promote effective contraception use and lower rates     of HIV acquisition worldwide.   "
41609|NCT02740985|"     This is a Phase I, open-label, multicenter study of continuous oral dosing of AZD4635     administered as a single agent and then in combination with a PD-L1 antibody, durvalumab. The     study design allows an escalation of dose with intensive safety monitoring to ensure the     safety of the patients. The primary objective of the study is to determine the maximum     tolerated dose of AZD4635 in combination with durvalumab.   "
41610|NCT02740972|"     The main objective of this study is to evaluate the safety of a high (80mg/kg) and low     (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with     Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives     include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.   "
41611|NCT02740959|"     This study is for an add-on study to the main study (Protocol No.: PH-CP012). The     information of patients from main study will be collected by questionnaire survey and     actigraphy measurement to evaluate the relationship between fatigue, depression and sleep     disorder and the efficacy of PG2 after treatment.The association between symptom cluster and     circadian rhythm will be also further explored.   "
41612|NCT02740946|"     This study aims to evaluate the effect of 5 months of exercise therapy for patients with     irreparable rotator cuff tears.   "
41613|NCT02740933|"     This research study is studying a drug called Demeclocycline that may help brain surgeons see     tumors with a microscope during surgery.   "
41614|NCT02740920|"     Studies have shown that the study drug, pembrolizumab, works by helping the immune system. In     this way, pembrolizumab may help to slow the growth of melanoma or may cause cancer cells to     die. Compared to standard treatments, pembrolizumab seems to lengthen the time patients lived     overall and the time without their cancer getting worse.   "
41615|NCT02740907|"     Objective:      Premolar autotransplantation represents an effective therapeutic option for the treatment of     juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the     osteoinductive potency of the method, however, to date no quantitative data has been     provided. The objective of this prospective clinical study was to quantitatively assess the     bone and soft tissue levels after autogenous premolar transplantation by clinical and     radiographic parameters.      Materials/Methods:      In the study 26 premolars were transplanted in 20 patients after traumatic dental injury     (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were     evaluated. Based on a standardized photo documentation, the relative soft tissue level was     measured in comparison to the healthy adjacent teeth. Radiographic findings involved the     evaluation of root resorption, pulp canal obliterations and the relative bone height. Patient     satisfaction was determined using a standardized questionnaire.   "
41616|NCT02740894|"     Not significantly increased survival in T/T   "
41617|NCT02740881|"     Adolescent substance abuse results in significant negative outcomes and extraordinary costs     for youths, their families, communities and society (societal costs estimated at over $400     billion annually and greater than costs for any other health problem). There is a clear     public health need for improving and expanding the delivery of evidence-based treatments for     adolescent substance use, but despite this clear need, there is a large divide between     science and practice. This project will develop a cost-effective, easily accessible,     web-based Training Support System (TSS) for Contingency Management that incorporates ongoing     training, feedback, and support provided to both counselors and their community-based     agencies.   "
41618|NCT02740868|"     Aim of this study is to evaluate image quality and reproducibility of Xenon-129 Magnetic     Resonance Imaging (MRI) and to evaluate changes in lung structure and function in     participants with cystic fibrosis (CF) and asthma compared to healthy controls using     Xenon-129 MRI.   "
41620|NCT02740842|"     Alive & Thrive (A&T) is a multi-year initiative to improve infant and young child feeding     (IYCF) practices. During Phase 1 (A&T-1, 2009-2014), funded by the Bill & Melinda Gates     Foundation, A&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices     in three countries - Bangladesh, Ethiopia, and Viet Nam.      In 2014, IFPRI in collaboration with DATA conducted the endline survey in Bangladesh. The     overall findings of the evaluation indicate that A&T's work in Bangladesh is a remarkable     success story of scaling up what has been challenging to date in the field of nutrition:     complex, high intensity and at-scale behavior change communications interventions.      In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF     practices, expansion of operations and promoted practices into new areas, and diffusion of     IYCF information, two years after the termination of external project support.   "
41621|NCT02740829|"     Peripheral glucagon action increases hepatic glucose production. In rodents hypothalamic     action of glucagon paradoxically suppresses glucose production. Intranasally administered     peptides have been shown to preferentially enter the central nervous system. We assessed the     effects of intranasal glucagon on hepatic glucose production   "
41622|NCT02740816|"     The purpose is to investigate how menstrual blood differs from systemic blood to evaluate if     menstrual blood could be utilized as a natural and non-invasive access to blood for regular     health monitoring and early diagnostics.   "
41643|NCT02740543|"     Asthma is a heterogeneous disease, and although much is understood about mechanisms of     inflammation in allergic asthma, less is known about mechanisms of irritant-induced asthma     (IA). Understanding the underlying similarities and differences in mechanisms of these two     types of asthma will help focus current treatments and lead to development of new therapies.     There is a longstanding NYU/Bellevue Asthma registry (NYUBAR), with a large population (N =     900) of asthma cases and controls, a program that has been housed at the CTSI (formerly     GCRC). The destruction of the World Trade Center (WTC) resulted in massive dust, gas and fume     exposures to local residents, workers and cleanup workers and individuals involved in rescue     and recovery and adverse respiratory health effects of this disaster are reported more than 7     years after 9/11. Many responders, as well as those exposed as residents or local workers,     have developed IA, asthma that arises after a lag from an environmental exposure . The WTC     Environmental Health Center (WTC EHC) is one of the three New York City (NYC) WTC Centers of     Excellence and the only one that focuses on treatment and monitoring of local workers and     residents. As such, it has a large population of individuals with irritant-induced asthma. It     has been proposed to use participants from the NYUBAR and the WTC EHC to expand the knowledge     of irritant and allergic asthma. Non-invasive studies allow for the assessment of airway     inflammation, a non-specific response to environmental exposure and injury. Recent     technologies also allow for assessment of microRNA (miRNA), small RNAs that regulate gene     expression at the post-transcriptional level and thus serve as a pathway to regulation of     inflammation. The hypothesis will be tested in that airway inflammation in irritant and     allergic asthma may be similar, but result from divergent miRNA regulatory pathways expressed     in sputum cells. These studies will provide preliminary data for future studies that will     help identify biological pathways to categorize these asthma phenotypes and target future     treatment interventions.   "
41623|NCT02740803|"     Caries prevalence has declined significantly since the introduction of fluoridated     toothpastes. Since then, different toothpaste formulations and concentrations have been     introduced to the market with varying levels of efficacy. There are several commercially     available toothpastes to choose from and only with the aid of sound methodological research,     can the best evidence-based oral education advice be delivered.      This is a double-blinded randomised controlled trial that aims to measure the salivary     fluoride concentration following tooth-brushing with several toothpaste formulations. Power     calculations were performed using PASS 11.0 software, and calculations showed that 3     participants are needed in each group in order for results to be considered as significant.     We will aim to recruit five to seven participants in each of the 12 groups. Research will be     publicised by means of flyers and circulating emails amongst University of Leeds students.     Information sheets will be provided to all participants and informed consent will be     obtained.      Each participant will brush with one of 6 different formulations of toothpastes either with     or without water rinsing post-brushing. Participants will randomly be assigned to groups     using an online random team generator. Saliva will be collected six times once before     brushing and at 1, 15, 30, 60 and 90 minutes post-brushing. Samples will be analysed using     fluoride ion-specific sensitive electrode connected to an ion analyser.      A statistician's help will be sought for analysis of the results. After the analysis stage,     the codes of the toothpastes will be broken.   "
41624|NCT02740790|"     Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16     and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response     in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26     years age group and 27-45 years age group in terms of immunogenicity.   "
41625|NCT02740777|"     To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose     immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle     vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in     adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6     months) in young females aged 18 to 26 years.   "
41626|NCT02740764|"     Aging is often associated with multiple chronic conditions conducting increased consumption     of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of     drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy,     increases the iatrogenic risks and can lead to adverse events such as falls, cognitive     decline, increased use to the health system: hospital admissions, emergency room visits, and     institutionalization. These problems are common since about 20% of emergency room use in     elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events     related to drug prescriptions could be avoided.      Interventions to optimize drug therapy showed a reduction in the number of potentially     inappropriate medications, but their impact on health, has rarely been evaluated. If an     association with death has been established, the link with the loss of functional autonomy,     which leads to reduced quality of life and significant cost of care, has not been     investigated. The evolution towards functional disabilities, frequent with aging has many     causes, among which some could be prevented. The optimization of drug prescriptions could     thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse     events, such as falls or cognitive decline and improving the management of chronic diseases.     Our hypothesis is that an optimization program of the drug prescribing may slow progression     to functional dependence. To assess the effect of the optimization program of drug     prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial     will be conducted in geriatric and memory consultations.      Expected results The implementation of the OPTIM program should enable optimization of drug     prescribing in elderly patients and therefore slow or prevent progression to addiction. It     should also help to develop and strengthen collaboration and communication between the team     of geriatric consultation, the clinician pharmacist and referring physicians in town (private     practice). In addition, pharmaceutical notice sent to referring physicians should help raise     awareness of the prescription of drugs in these patients.   "
41627|NCT02740751|"     Herbal teas with galactogoge effects have been used extensively in recent years in order to     increase the amount of breast milk in lactating mothers. We also investigated whether a     sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these     mothers. Plain water was used as placebo.   "
41628|NCT02740738|"     To investigate the association between grip strength and preoperative pain threshold as     measured by pressure algometer and validated pain outcome surveys.   "
41629|NCT02740725|"     Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a     complementary method of patching in amblyopia therapy.      Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic     children (25 male/25 female) less than 10 years with either best corrected visual acuity     (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of     VA≥2 lines between two eyes will be included. Patients will be classified in the case and     control groups (25 in each), randomly. Patching will be recommended in both, cases will also     received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with     conjugate colored filters. Patching was continued for one month more in both groups. VA and     stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one     month after I-BiTTM treatment.   "
41630|NCT02740712|"     The purpose of this study is to assess pharmacokinetic concentrations of multiple probes     alone followed by assessment of the same drug pharmacokinetic concentrations when the patient     has steady-state exposure to rucaparib followed by cycle-by-cycle treatment with rucaparib     continuing until disease progression or other reason for discontinuation.   "
41642|NCT02740556|"     There is limited data outside of clinical trials on adherence to once daily     ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication     adherence including untreated psychiatric illness and substance use disorders, cognitive     impairment, and low health literacy. The goal of this study is to evaluate the baseline level     of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to     the level of adherence in patients provided with additional adherence support. Medication     adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device     that measures the dosage and time a medication was taken. Using cellular technology,     AdhereTech can be used passively to collect data on when a medication is taken, when a refill     is needed, and how often the bottle is opened. AdhereTech also can be used actively to     monitor adherence and provide feedback to subjects using the device. When actively     monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up,     sounding chimes, and sending phone/text/email alerts to remind patients to take their     medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the     form of a dashboard for medical providers (MDs and NPs) and an application (or app) for     patients. The app allows patients to become active participants in their treatment by     enabling them to set medication reminders, record doses taken, and communicate their     adherence to their medical provider using the provider dashboard.   "
41631|NCT02740699|"     Background:      Coronary artery disease causes plaque in arteries. This can cause stroke or heart disease.     Drugs called statins might shrink plaque. Researchers want to study how CT scanning can     determine if an individual s arterial plaque has decreased while taking statins.      Objectives:      To measure the change in coronary artery plaque volume in people treated with high-intensity     statin therapy using CT and MRI scans. To study the metabolic activity of plaque in arteries.     To determine how well plaque measurements from heart CT scans can be replicated.      Eligibility:      Men ages 45-75 and women ages 50-75 who are good candidates for statin treatment      Design:      Visit 1: participants will be screened with:        -  Medical history        -  Blood tests        -  Heart MRI and CT scan: An IV inserted into an arm or hand vein removes blood and injects      contrast, and medicine if needed. Participants lie on a table that slides into a machine that     takes pictures of the body. For the CT scan, if their heart rate is too high, they get     medicine to lower it. They breathe in a special way, holding their breath for 5 seconds.      Participants will begin high-intensity statin treatment.      Participants will have 7 more visits over 3 years. All visits include blood tests and     medication review. Some may also include:        -  Statin treatment adjustment        -  CT scan        -  MRI scan        -  Physical exam      Participants may join the PET Substudy. This includes 5 more visits during the study. These     include:        -  Getting an IV in an arm vein        -  Blood tests        -  PET scans: They fast 12 hours before.      Participants may join the Reproducibility Substudy if they had a slow heart rate during their     first CT scan. This includes 1 additional heart CT scan 4 weeks later.   "
41632|NCT02740686|"     This study will examine the inflammatory response to exercise encompassed as part of a     standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary     disease (COPD). Patients will be split into two groups, frequent exacerbators or infrequent     exacerbators, dependent upon exacerbation history to compare responses to pulmonary     rehabilitation amongst phenotypes.   "
41633|NCT02740673|"     Little is known about the causes and degree of cognitive dysfunction in patients with Chronic     Obstructive Pulmonary Disease (COPD), especially their driving abilities. The purpose of the     study is to examine the cognitive skills of patients with COPD by using a driving simulator     and to examine correlations to factors that may predict cognitive dysfunction in these     patients.   "
41634|NCT02740660|"     The purpose of this study is to determine whether taking a combination of caffeine and     albuterol three times per day will increase muscle and decrease fat in your child's body and     to determine how these medications make your child feel. Albuterol is approved by the FDA for     the treatment of asthma. It is not approved to increase muscle and decrease body fat in     children.   "
41635|NCT02740647|"     Orthognathic surgery is the state of art of the maxillofacial surgery, it fix and normalize     facial abnormalities and create a harmony between the different tissues compounding the face     (bone, soft tissue and dental structures). It is a common procedure and it is done in order     to correct a dentofacial and skeletal deformities.      There is an inevitable risk of complications with this type of surgery. While postoperative     infections are the most common complication (2% to 33.4%).      preoperative administration of antibiotics have been proven to be effective in reducing the     postoperative infection rate, while, the quality of the currently available literature in     prescribing continues postoperative antibiotics is questionable and there is still no     consensus on its efficacy.      Unwise administration of antibiotics may cause several unwanted side effects such as     gastrointestinal symptoms, allergy reactions, high costs, etc… while the most worrisome side     effect is a bacterial resentence.      The objective of this study is to investigate the efficacy of postoperative antibiotics. And     will try to state a consensus in prescribing postoperative antibiotics. By conducting a     prospective, randomized, double-blind, placebo-controlled study, that will explore and     analyze the efficacy of postoperative administration of Amoxicillin Clavulanate versus     placebo in reducing the rate of postoperative infections in 60 healthy patients.   "
41636|NCT02740634|"     This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain     of patients with Atypical Alzheimer's Disease and how burden may change over a two-year     period.   "
41637|NCT02740621|"     In this study, the risk of opioid medications on coronary heart disease in adults is     investigated. Patients with the necessity of a coronary angiography and control patients with     a non-cardiac disease of the same hospital are inquired with a standardized questionnaire     about demographic and clinical risk factors for heart attack. An impact of opioid medications     on coronary heart disease is hypothesised (MIOP).      In addition, all patients with coronary angiography should be consulted twice (after 3 and 6     months) to find out how many of these patients have developed a refractory angina pectoris     (TRAPS).   "
41638|NCT02740608|"     This study is designed to determine if a rejected liver is viable using normothermic machine     liver perfusion (NMLP). It aims to        1. establish the suitability of livers which have been declined by all UK liver transplant          centres by monitoring their function on the NMLP machine; and,        2. transplant the liver if its function on the machine is satisfactory allowing it to be          transplanted.   "
41639|NCT02740595|"     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and     sham control, on endothelial function and markers of oxidative stress.   "
41640|NCT02740582|"     The purpose of this study is to determine the effects of tolcapone on decision making and     alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol     drinkers.   "
41641|NCT02740569|"     Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary     involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known     regarding the prevalence of OSA in scleroderma and its association with pulmonary     involvement.   "
41655|NCT02740387|"     This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral     Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at     3-month intervals for a total of 4 injections total.   "
41656|NCT02740374|"     The purpose of this study is to determine whether the use of ROTEM, during spinal surgery is     effective on diminishing the total blood loss and the risk of Allogenic Transfusion of Blood     Products vs control cases without ROTEM assessment.   "
41646|NCT02740504|"     A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The     device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen     Easy, which uses chest effort bands.      The RR was measured over a short duration on subjects sitting upright in a chair, with the     non-contact sensor at various distances from the subject. A total of 20 subjects were tested,     from both genders, selected to represent a wide range of age and body mass index   "
41647|NCT02740491|"     The main objective of this study is to describe the evolution in quality of life (QLQ-C30)     for patients receiving breast cancer care at 3, 6 and 12 months after a remission     consultation.   "
41648|NCT02740478|"     The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in     performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects     over a number of hours when the subjects are lying still or in bed asleep   "
41649|NCT02740465|"     This prospective, multicenter, cohort study is designed to validate Anxiety Inventory     Respiratory Disease questionnaire in patients with Chronic Obstructive Pulmonary Disease     (COPD).      The primary purpose of this study is to assess the validity of the Anxiety Inventory     Respiratory (AIR) scale in detecting anxiety in relation to the DSM-V criteria in patients     with COPD.        -  To evaluate associations between COPD symptom scores assessed by the CAT questionnaire          and MMRC dyspnea scale and measures of depression and anxiety        -  To evaluate associations between physiologic measures of lung function (spirometry) and          exercise tolerance (6 minute walk) and measures of depression and anxiety        -  To evaluate associations between exacerbations of COPD and the prevalence of anxiety and          depression in a cohort of COPD patients   "
41650|NCT02740452|"     The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical     technique versus standard technique.      The aim of the study is to compare (laxity, instability, and safety) these two types of     treatment by using a prospective, randomised multicenter analysis.   "
41651|NCT02740439|"     The proposed work will investigate the effects of avocados on abdominal obesity and glycemic     control among overweight/obese adults.   "
41652|NCT02740426|"     This clinical trial is designed to evaluate the efficacy of single immediate intravesical     chemotherapy instillation in the prevention of bladder recurrence after diagnostic     ureteroscopy for upper tract urothelial carcinoma (UTUC) patients.   "
41653|NCT02740413|"     The overall aim of the study is to describe demographic and clinical characteristics,     treatment patterns and outcomes, in the populations of hemophilia patients treated with     BeneFIX and ReFacto/ReFacto AF in Sweden   "
41654|NCT02740400|"     This is a randomized controlled trail aiming at comparing the diagnostic value and safety of     endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided     transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients     eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly.     The diagnostic indicators such as sensitivity, specificity, and accuracy are compared between     the two groups. Post-procedure complications are recorded.   "
41802|NCT02738476|"     The primary purpose of this investigation is to report the short-term clinical outcomes (2-3     years) of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.   "
41658|NCT02740348|"     The purpose of this trial is to determine whether setting up a follow-up appointment for     patients who received treatment and were discharged from the emergency department increases     their compliance with the follow-up appointment. We are enrolling patients who need a     follow-up visit, have health insurance but report do not have a primary care doctor. Patients     are randomized to one of three treatment groups: (1) assistance setting up a follow-up     appointment by a research assistant using ZocDoc; (2) ZocDoc information given to the subject     to set up follow-up appointment by him/herself; or (3) usual discharge instructions by ED     staff. Subjects are phoned approximately 2 weeks after the ED visit and asked whether they     completed a follow-up visit, satisfaction with their ED visit, satisfaction with their     follow-up visit, and additional ED treatment and recovery.   "
41659|NCT02740335|"     To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K     Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is     clinically non-inferior to that Beriplex® P/N (Kcentra).   "
41660|NCT02740322|"     The sensitivity and specificity of the Hum Test is being investigated in it's ability to     detect conductive hearing loss. The hum test is simply elicited by asking the subject to hum     to him or herself for a few seconds at both a high and low pitch that is comfortable for the     subject. The subject is then asked if the hum was heard on one side more than the other (left     or right), or if the sound was equal on both sides. To simulate conductive hearing loss, ear     plugs will be placed in one of the subject's ears. We will elicit the hum test as well as the     standard Weber test and audiogram across two conditions, with an ear plug and without an ear     plug. From this, it is hoped to assess how the Hum Test compares to the audiogram (gold     standard) in detecting conductive hearing loss as well as how it compares to the standard     Weber test. If the Hum Test demonstrates strong sensitivity and specificity in detecting     conductive hearing loss, it could have application as being utilized as an alternative to the     standard Weber test, or in a setting where a formal physical examination may not yet be     possible but where the etiology of a patient's hearing change could be quickly assessed     remotely and thus the urgency of intervention/ consultation could then be determined.   "
41672|NCT02740166|"     Esophageal variceal bleeding is a severe complication of portal hypertension. Banding     ligation plus non-selective beta-blockers is the current recommendation for prevention of     recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is     not well defined. This study aims at comparing the rebleeding rate and adverse effects in     patients using or without using propranolol after eradication of esophageal varices.   "
41822|NCT02738216|"     This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning them     to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a     series of educational workshops focused on perinatal health, the Mom and Baby Wellness     Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor     all participants in the study for safety and clinical deterioration, and measure a variety of     symptom outcomes over the course of the intervention period during pregnancy, as well as at a     postpartum follow-up.   "
41661|NCT02740309|"     Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be     screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety     Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology     clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm     diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial     risk assessment as well as medical and socio-demographic inventories. The investigators will     include youth that meet full criteria for major depressive disorder and any anxiety disorder,     dysthymic disorder, and any adjustment disorder. The investigators will also include patients     with subclinical symptoms that have significant psychosocial stressors in addition to their     medical illness. Patients will be excluded if they have active suicidal ideation with plan     requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders,     or significant intellectual disability/developmental delay. Participants meeting inclusion     criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink     social worker or treatment as usual (TAU), which is a facilitated community referral for     mental health treatment.   "
41662|NCT02740296|"     Depression is one of the most common symptoms of multiple sclerosis (MS) with a life-time     prevalence of major depressive disorder (MDD) of up to 50%. Depression occurs more frequently     in MS than in other chronic diseases including other neurological and inflammatory disorders     and may contribute to lower quality of life, cognitive problems, difficulties at work, and     poorer long term health outcomes. Despite its clinical relevance, the biological mechanisms     which may be responsible for the high risk for MS patients to develop depression are unknown.      In this observational study, investigators explore the molecular mechanisms responsible for     the impaired regulation of immune cells in relapsing-remitting (RR) MS patients with     depression. Investigators will compare the molecular and phenotypical profile of immune cells     obtained from RRMS patients with clinical depression (n=50), matched MS patients who do not     suffer from depression (n=50) as well as matched healthy controls (n=50) and matched patients     with depression but without a comorbid neurological disorder (n=50).   "
41663|NCT02740283|"     The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an     early diagnosis method of GDM in low risk pregnant women. By investigating maternal and     neonatal outcomes that are associated with the early OGTT and regular OGTT results, the study     will provide a evidence for the most appropriate time to perform an OGTT in pregnant women.   "
41664|NCT02740270|"     The purpose of this trial is to explore the clinical utility of two investigational     antibodies in patients with advanced cancer or lymphomas.      This is a multi-center, open-label Phase I/Ib study. The study consists of two dose     escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in     combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test     different dosing schedules.      The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation     part to assess the activity, safety and tolerability of the investigational products in     patients with specific types of cancer and lymphomas.      Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.   "
41665|NCT02740257|"     The primary objective of Part One of this study is to determine the sensitivity of an     automated total body digital photography (TBDP) app to detect color and size changes in the     human skin, and whether a new lesion has arisen.      The primary objective of Part Two is to test the sensitivity and specificity as well as     feasibility of field use of an automated TBDP app to detect pigmented and non-pigmented skin     lesions in high risk populations.   "
41666|NCT02740244|"     The aim is to evaluate the evaluate the clinical interest and the safety of repetitive     transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst     stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar     disorder.   "
41829|NCT02738125|"     This study assesses the long‐term effectiveness of adalimumab in subjects starting a     treatment for ulcerative colitis in real life conditions, namely to describe the time to loss     of clinical benefit in a time to event approach.   "
41667|NCT02740231|"     Osteoarthritis (OA) is the most common joint disease affecting millions of people around the     world, for which there is unfortunately no cure. Among existing therapies,     viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an     established place in the symptomatic treatment of knee OA.      The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in     two phases. With results obtained in the first phase the best dose of JTA-004 is determined,     and the efficacy of the selected dose will then be confirmed in the second phase.   "
41668|NCT02740218|"     This is a retrospective, multi-center observational cohort study. This study will be     implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20     sites) and Sweden (approximately 25 sites), followed by a selected number of countries in     Europe, depending on apremilast local availability. The design of this apremilast     retrospective study aims to provide clinical information regarding the treatment initiation     and outcomes in psoriasis patients when prescribed apremilast in real world settings. In     addition, this study is aiming at capturing physicians' and patients' treatment goals when     initiating apremilast and whether these goals are achieved following apremilast use. This     study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients     must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with     plaque psoriasis and have been treated with apremilast during the previous 5-7 months to     participate in this study. They must not be involved in any other clinical study involving     apremilast.   "
41669|NCT02740205|"     The purpose of this trial is to evaluate the efficacy and safety of the implementation of an     Algorithm for enteral nutrition support compared with usual standard practice in non-critical     hospitalized patients: ASNET algorithm.   "
41670|NCT02740192|"     This is a randomized, double blinded, standard of care controlled clinical trial. All adult     patients over eighteen desiring total knee arthroplasty will be eligible. The study compares     pain control, opioid consumption, and physical exam findings in patients undergoing total     knee arthroplasty between patients receiving adductor canal block and those who receiving     periarticular injection alone.   "
41835|NCT02738047|"     Pharmocogenomic test assessment in the medication regimen and disease management for patients     under drugs known with genetic variation.   "
41673|NCT02740153|"     Urea cycle disorders (UCD) are genetic disorders caused by the liver's inability to breakdown     ammonia from proteins; ammonia then accumulates and is toxic to the brain. UCD cause brain     damage and intellectual and developmental disabilities and even death.      Treatment for UCD is either conservative management which involves a low-in-protein diet,     drugs, and amino acid supplements or liver transplantation; each carry their own risks.      This study aims to help patients to make decision about different management alternatives by     providing them with scientific information that is currently lacking.      Aim 1 of this study will compare survival, neurocognitive function, and patient reported     quality of life. Aim 2 of this study will consist of interviews and focus groups with     patients, their families, and their medical providers to determine important issues to     consider when deciding whether to continue conservative management or opt for liver     transplantation.   "
41674|NCT02740140|"     This observational epidemiologic study with nested cross-sectional and longitudinal aims will     evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent     tuberculosis, intestinal helminthiasis) in recent US immigrants.   "
41675|NCT02740127|"     During penile prosthesis surgery, participants are given general anesthesia in combination     with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the     tailbone, in addition to general anesthesia, which can lower the need for pain drugs.      The goal of this clinical research study is to learn how effective CNBs are in participants     who are having penile prosthesis surgery compared to participants who only have general     anesthesia by studying how long participant stays in the hospital and the level of pain they     have after surgery.   "
41676|NCT02740114|"     Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites.     Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes     to make them able to stay in the body for longer periods of time. This has been done with     bupivacaine to create liposomal bupivacaine.      The goal of this clinical research study is to compare the effects of bupivacaine to those of     liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers     want to compare how long the drugs work to numb the wound and how long patients take to     recover from surgery.   "
41677|NCT02740101|"     To examine potential differential effects of receiving various social feedback on achieving     personal goals,and whether oxytocin would modulate these effects.   "
41678|NCT02740088|"     This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic     valve could predict aortic stenosis progression in moderate aortic stenosis.      Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation     including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up     echocardiography. The study design is an observational trial. Primary endpoint was a change     in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year.     Secondary endpoints include changes in aortic valve area, and symptom occurrence.   "
41886|NCT02737358|"     The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to     assist in initial cessation and/or relapse prevention in adult cigarette smokers.   "
41679|NCT02740075|"     After cardiac surgery patients are transported from the operating room (OR) to the intensive     care unit (ICU) while intubated. Two principal methods of oxygenation and ventilation are     used: (1) a transport ventilator or (2) a Mapleson Bag-Mask hand ventilating circuit. The     choice of method is largely determined by the preference of the the anesthesiologist who is     transporting the patient. The investigators postulate that the choice of either method might     alter respiratory and hemodynamic parameters felt to be important for the immediate     management of post-cardiac surgery patients. The investigators will prospectively record     end-tidal carbon dioxide (ETCO2) (primary end-point) and change in minute volume, heart rate     (HR), Blood pressure (BP), pulmonary artery (PA) pressures and cardiac output during     transportation and upon arrival in the ICU. All of these variables are measured routinely but     are not recorded. The investigators will compare patients transported with a ventilator to     patients transported with a Mapleson circuit.   "
41680|NCT02740062|"     This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for     evaluation and treatment of neuropathic pain. The NIBS system evaluates brain neuronal     network activity and customizes a personalized treatment utilizing low current non invasive     brain stimulation technology for neuropathic pain with central component. this is single     meeting trial which includes brain activity evaluation and a single treatment and sham     treatment. The goal of the study is to evaluate the central brain component of neuropathic     pain subjects, and the effect of conventional tDCS treatment.   "
41681|NCT02740049|"     Asthma is a long term disease of the lungs. In asthma patients the sensitive airway tubes     narrow in reaction to something that irritates the airways such as allergens or environmental     pollutants. There is currently no cure for asthma and new medicines or combinations of     medicines are needed that will be of benefit to patients particularly those with a more     severe disease.      Activation of certain signal molecules inside the lung cells may participate in the     development of asthma and the response to allergens. Blocking these signal molecules     specifically with medicines might therefore be beneficial in the treatment of asthma. In this     study we want to test a new medicine that specifically targets a subset of signal molecules     that are associated with the allergen response in the lung. In particular, we want to test     this medicine on cells obtained from the lungs of asthma patients. Understanding the effects     of this new medicine on these asthmatic lung cells will give vital information on how this     new medicine works before we can test it in asthma patients.   "
41682|NCT02740036|"     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted     on hard of hearing participants to grant quality control prior to product launch. The aim of     the investigation series is to ensure zero-defect overall performance of the new hearing     systems as well as maximum benefit for the participant with the devices in comparison to     previously outstanding Phonak Hearing Systems and to equivalent competitor devices.   "
41683|NCT02740023|"     Phonak Hearing Systems pass through different development and study stages. At an early     stage, feasibility studies are conducted to investigate new algorithms, features and     functions in an isolated manner.   "
41684|NCT02740010|"     The purpose of this observational, non-controlled, multicenter trial with a retrospective     design is to evaluate the visual performance of one cohort of patients who received the     multifocal intraocular lenses (MIOL) MINI WELL® following refractive lens exchange (RLE) or     cataract surgery. Primary outcome were: Uncorrected Distance Visual Acuity, Best Corrected     Visual Acuity, Best Corrected Near Visual Acuity, onset of halos and glare (during night     vision). It was also evaluated: Distance-Corrected Contrast sensitivity without glare,     reading speed with the best correction for distance, and Defocus Curve under photopic     conditions. ADE/SADE/USADE and AE/SAE were secondary outcomes.   "
41685|NCT02739997|"     This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and     efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg for     the treatment of Complicated Intra-abdominal Infections (cIAI) in Japanese participants.     Efficacy will be primarily assessed by clinical response defined as complete resolution or     significant improvement in signs and symptoms of the index infection.   "
41686|NCT02739984|"     The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab     taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein     cholesterol (LDL-C) in subjects with type 2 diabetes mellitus and high blood cholesterol on a     maximally tolerated oral dose of statin of at least moderate-intensity.   "
41687|NCT02739971|"     The purpose of this study is to investigate whether dietary intake of pre-formed advanced     glycation end products (AGEs) modulates brain function measured by MRI) and cognitive     function measured by a thorough neuropsychological battery. In a 6 months randomized parallel     study of adults above the age of 65, with mild cognitive impairment (MCI) and type 2     diabetes. The investigators will compare two groups numbering 60 subjects each. Both groups     will be advised on a diet appropriate for type 2 diabetes in the elderly by a nutritionist.     In addition, the intervention group will be instructed on how to cook a low-AGE diet , with     the aim of achieving a 40-50% lower AGE content, and they will be closely followed throughout     the study to ensure compliance. Since diet is a modifiable lifestyle, diminishing AGEs     consumption by cooking in lower temperatures (higher cooking temperatures being associated     with higher AGE production) may be a simple non-invasive intervention which has potential of     delaying or preventing cognitive decline which is associated with dementia.   "
41688|NCT02739958|"     The aim of this prospective, randomized clinical study is to compare between propofol and     isoflurane on perioperative immune cell populations and function in patients undergoing total     laryngectomy surgery.   "
41689|NCT02739945|"     The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at     the elbow after open release or endoscopic release.   "
41789|NCT02738645|"     From 2003 when Severe Acute Respiratory Syndromes (SARS) appeared，many new types of     respiratory viruses emerge in endlessly. Therefore, the epidemiology and the clinical     character has changed quietly, especially severe pneumonia. This cohort study aim to obtain     the contents of severe pneumonia patients in Respiratory Intensive Care Unit (RICU). Through     the clinical data analysis, the investigators could get the information of the pneumonia     caused by different reasons, such as morbidity and mortality, risk factors, clinical symptoms     and radiographic changes, the respiratory support parameter and so on. The investigators hope     the result could guide them do the clinical work of severe pneumonia better in the future.   "
41690|NCT02739932|"     The primary study aims are to determine the clinical, behavioural and social predictors of     SMI development in youth, and to investigate whether neuroimaging can distinguish youth who     will develop SMI from those who will not.      The study's secondary aims are to examine the proportions of the cohort that make transitions     between the different clinical stages of risk, and to determine the proportions that have     poor outcomes, defined as ongoing or increased symptoms, secondary substance misuse, poor     social or role functioning, i.e., non-participation in education, or employment, and new     self-harm.      Investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes     youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group;     n=160), youth at risk due to a family history of a SMI (family high risk (FHR); n=40), and     healthy controls (HC; n=40). From this cohort, clinical, social and cognitive data, as well     as imaging data will be gathered to create a multi-layered snapshot of these individuals     and provide full-level characterization. Investigators will use the full range of clinical     and imaging data generated from this cohort to develop novel prediction algorithms     incorporating key variables that predict the development of SMI.   "
41691|NCT02739919|"     The aim of this research is to use a controlled laboratory setting to determine whether     bacteria isolated from kidney stones of patients play a role in the formation of     non-infectious kidney stones. It is well known that struvite stones are associated with     active bacterial infection, however the role of bacteria in the formation of non-infection     stones (like calcium oxalate) is not well characterized and there are theories that bacteria     are involved in the making of these stones.   "
41692|NCT02739906|"     This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial     in subjects with type 1 diabetes mellitus.      Each subject will be administered individualised single subcutaneous doses of BioChaperone     Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin®     Normal) immediately before ingesting a standardised mixed meal.      Following trial drug administration, PK and PD assessments will be carried until 6 hours     after start of the standardized test meal.      The total trial duration for an individual subject will be up to 11 weeks.   "
41693|NCT02739893|"     The aim of this study is to see if use of ScopeGuide, as compared to the traditional     colonoscope, improves successful completion of colonoscopy procedures as evaluated by ease of     completion, time to completion, and reduction in the number of mechanical loops and external     maneuvers required to advance the scope. Other outcome measures include looking at the amount     of sedation required (independent of weight) and polyp rate detection.   "
41694|NCT02739880|"     The main objective of this study is to measure changes in the thickness of the vaginal lining     (epithelium + underlying stroma) between 0 and 8 weeks after injection.   "
41955|NCT02736461|"     In patients suffered from floor fractures, there are 21.9% complaining about diplopia before     fracture repair surgery and 20.8% after operation. Even after 6 months, there still are 16.4%     had similar conditions. Investigators are planned to find predicting factors to prevent such     conditions from happening.   "
41695|NCT02739867|"     Among patients with a first episode of unprovoked venous thromboembolism (VTE), the     contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these     cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of     platelets is a promising, highly accurate biomarker for cancer detection, but its clinical     utility in patients with unprovoked VTE is unknown. The objective of the present study is to     evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in     patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of     other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.   "
41696|NCT02739854|"     The purpose of this study is to identify the prevalence rate and risk factors for pulmonary     complications in patients with critical trauma who intubated and mechanical ventilation.   "
41697|NCT02739841|"     The purpose of this study is to explore acute hemodynamic responses to VHI technique in     critical traumatic patients with pulmonary complications in the intensive care unit.   "
41698|NCT02739828|"     The objective of this study is to assess quality of life (QoL), skin pain, work     productivity/activity and health related problems in Swedish patients with moderate to severe     HS before and after 6 months treatment with Adalimumab. The patients will be treated in     accordance with normal routine clinical care.   "
41699|NCT02739815|"     This study aims to define a safe prophylactic intravenous TXA dose with an advantage over     others in reducing total blood loss volume at secondary uncomplicated LSCS.   "
41700|NCT02739802|"     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.   "
41701|NCT02739789|"     This research study identifies neural pathways regulating negative moods during rejection by     combining transcranial direct current stimulation (tDCS) and fMRI in a sample of healthy     controls.   "
41702|NCT02739776|"     The purpose of this study is to describe infrared thermographic imaging as a tool for the     assessment of epidural block in obstetrics patients   "
41703|NCT02739763|"     The investigators wish to understand how resistance to malaria develops and how this affects     the growth rate of malaria in individuals who have past exposure to malaria.   "
41704|NCT02739750|"     Chronic Kidney Disease (CKD) is associated with bone changes and very high fracture rates. A     component of bone is marrow. Bone marrow fat is increased in patients with CKD compared to     those in the normal population of the same age. It is not clear if there will be changes in     the marrow fact content in those with CKD on Pioglitazone. In people with normal kidney     function, thiazolidinedione group of drugs have had variable effects on bone marrow fat     content, as measured by MRS. This is important as changes in marrow fat are likely related to     changes in the bone in patients with chronic kidney disease.   "
41705|NCT02739737|"     No consensus exists among biomedical journals on the subject of blinding during the peer     review process. Some journals attempt to remove all identifiers of authorship from potential     manuscripts before delivering to referees for peer review while others prefer to leave the     authorship transparent. Although peer review remains the gold standard for manuscript     evaluation, the lack of a standardized blinding process between editorial offices may be a     source of publication bias and make comparisons of manuscripts published in different     journals more difficult to interpret.      Proponents of a blinded peer review system believe that knowledge of authorship may leave     referees vulnerable to biases about those authors' previous research, perceived expertise,     institution, nationality, or gender. This shifts judgment away from the merits of the     scientific work and introduces pre-conceived notions about the identity and background of the     author into the review process. Conversely, supporters of transparent authorship argue that     knowledge of author identity makes it easier for the referee to provide more appropriate     critiques. Open author identification allows referees to compare the current manuscript to     previously published work by the author, and to recognize or identify potentially important     conflicts of interest.      The investigators therefore propose an experimental study to address the question of whether     blinding affects the likelihood a reviewer will recommend acceptance of a study being peer     reviewed. The investigators plan to work in partnership with a journal to have a fabricated     manuscript peer reviewed by a large number of reviewers; the authors will send this test     manuscript out either in blinded form (authors' names/institutions not shown to reviewers) or     in open form, with the names of several well-known, well-regarded authors and their     institutions visible to peer reviewers. The manuscripts will otherwise be identical.      The partnering journal, Clinical Orthopaedics and Related Research allows both open and     blinded peer review, regularly employing both approaches (authors can choose what kind of     review they prefer when they submit to CORR), and so the reviewers are unlikely to be     troubled by seeing a manuscript in either format.      The primary goal of this study is to determine whether the identification of a manuscript     with a prominent group of authors (open authorship) will affect the likelihood that reviewers     will recommend the manuscript for publication.      Additionally, the investigators plan to purposely place several errors in the manuscript, and     tally how often reviewers detect these mistakes, to determine whether reviewers read the work     of prominent authors less critically.      The investigators will also compare the reviewers' grading of the (identical) methods     section, to determine whether the identification of a manuscript with prominent authors     results in higher reviewer grades for methodological rigor.      This study tests the following specific hypotheses:        1. The visibility of prominent author names and institutions on test manuscripts will be          associated with increased likelihood that the manuscript will be recommended for          publication by peer reviewers. (Primary Study Endpoint)        2. The visibility of prominent author names and institutions will be associated with a          decreased likelihood that purposefully placed errors in the experimental manuscript          will be detected by the reviewers.        3. The visibility of prominent author names and institutions will be associated with          increased scores given by reviewers for the methods section, despite the fact that the          methods sections of the experimental manuscript will be identical.      NOTE:      All elements of the research protocol were approved by the University of Washington Human     Subjects Review Committee, including the study's opt-out design for reviewer recruitment,     since it was considered important that reviewers not know that the paper they evaluated was     part of a study. To minimize the potential for harm, the authors chose as the topic of the     fabricated test manuscript an intervention that could not be immediately put into practice at     reviewers' own centers (a particular team-training process in the operating room). In     addition, participating reviewers were informed which paper was the test manuscript at the     completion of data collection, so that they did not pursue this sort of team training based     on the results of the fabricated study.      To reduce the risk of an observer (Hawthorne) effect, it was important to minimize the     likelihood that participant reviewers would learn of the study while it was in progress. To     this end, the investigators elected not to pre-register the study in a trial registry.   "
41719|NCT02739555|"     Osteoid osteoma (OO) is a benign osteogenic tumor occurring in children and young adults,     responsible for intense bone pain, which has a tendency to spontaneously heal with     mineralization of the nidus, but extremely slowly. This healing may be accelerated in     patients taking NSAIDs regularly during a few years. The long delay for healing and intense     pain, explain why patients are quickly directed to surgeons or specialized radiology     departments for tumor ablation. But percutaneous treatment or surgical excision destruction     can expose the patient to a substantial risk in terms of neurologic or joint damages,     depending on the location. Bisphosphonates treatment may be an effective alternative to     percutaneous treatment by accelerating the natural history of OO.   "
41706|NCT02739724|"     Introduction      Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies.     Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results     of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So     it seems interesting to conduct a new study about this technic. Aim of this study is to     compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic     laparoscopy (CL).      Materiel and Methods      We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years     requiring laparoscopic surgery for adnexal pathology with stratification for procedure     (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in     two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative     pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative     complications, duration of procedure, postoperative quality of life and immediate     postoperative pain.      We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic     scale 0-10). The estimated size of population number is 54 per group and 108 for the study.      Expected results      We expected a significant decrease of postoperative pain with SPA technic. This data will be     interesting to promote use of SPA technic for adnexal surgery.   "
41707|NCT02739711|"     Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion     success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction     and angiographic evidence of no-reflow.   "
41708|NCT02739698|"     A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed     with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical     surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues     (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia     intraperitoneal intraoperative chemotherapy with paclitaxel   "
41709|NCT02739685|"     The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting     bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total     occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.   "
41710|NCT02739672|"     randomized, open-label, single dose, replicate crossover clinical trial to compare the     pharmacokinetics of TAH tablet in comparison to the co-administration of telmisartan,     amlodipine and hydrochlorothiazide in healthy male volunteers   "
41711|NCT02739659|"     The aim of this research project is to assess the feasibility and safety of carbon-ion     radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer   "
42093|NCT02734667|"     The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM)     on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope     to learn about how continuous glucose monitoring affects glycemic variables and     diabetes-related distress.   "
41712|NCT02739646|"     Rationale: The representation of the breast on the somatosensory cortex has not been     precisely located. Therefore, a pilot study with healthy subjects is needed to localize the     sensibility of the breast on the somatosensory cortex with the use of a 7 Tesla fMRI.      Objective: To determine the exact localization of the representation of the sensibility of     the breast and nipple-areola complex on the somatosensory cortex. Secondly, to assess whether     there are differences in representation between individuals of the same sex and between both     sexes.      Study design: A single center pilot study carried out in the Maastricht University Medical     Center, the Netherlands.      Study population: A total of 10 female and 10 male healthy individuals will be recruited.      Intervention: Every subject will undergo a functional MRI scan with stimulators applied to     the bare breast in a fixed pattern. These stimulate the skin and sensory nerves of the breast     and nipple-areola complex in a random sequence.      Main study parameters: The hemodynamic response after stimulation of the skin of the breast     and nipple-areola complex, representing neuronal activity in that region, is measured. Within     the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the     various stimulation conditions are assessed, and the representation of the breast on the     somatosensory cortex is mapped.   "
41713|NCT02739633|"     Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and     Metastatic Adenocarcinoma of the Pancreas.   "
41714|NCT02739620|"     Exercise training has beneficial effects in cancer survivors to minimize some of the side     effects of cancer and its treatment and improve long-term prognosis, but there are numerous     hurdles for individuals diagnosed with, and being treated for, cancer to participate in     exercise programs. The goal of this research study is to begin to evaluate whether exercise     training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal     muscle size and function in cancer survivors.   "
41715|NCT02739607|"     Objectives        1. To test the effectiveness and acceptability of an augmented internet-supported          transdiagnostic intervention in Romania.        2. To assess the cost-effectiveness of the Internet version of the transdiagnostic program          as compared to a standard treatment/usual care.   "
41716|NCT02739594|"     This multicenter, open-label trial will randomize participants with multiple myeloma to a     regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity,     measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an     absolute value of 30 milliliters per minute (mL/min) or lower.   "
41717|NCT02739581|"     The patients will be randomized into two groups        1. Endoscopic Variceal Ligation with Non Selective Beta Blocker        2. Placebo with Endoscopic Variceal Ligation   "
41718|NCT02739568|"     The first objective of this study is to demonstrate the efficacy and safety of pitolisant     given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,     to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea     (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by     nCPAP but still complaining of EDS.      The secondary objectives of the study include assessing the long-term tolerance as well as     the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of     Open Label Extension period and further investigating the co-variates or co-medications that     affect the pharmacokinetics of pitolisant in the target population.   "
41720|NCT02739542|"     The purpose of this investigation is to systematically study the efficacy of Tecfidera in     those individuals who possess incidental white matter anomalies within the brain following a     MRI study that is performed for a reason other than for the evaluation of MS (multiple     sclerosis).   "
41721|NCT02739529|"     Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks     for gynecologic cancer (adult solid tumor): a phase I trial.   "
41727|NCT02739451|"     Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised     patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a     nasal cannula or mask [with or without a bag and with or without the Venturi system] to     achieve SpO2≥95%.      Oxygen therapy may be combined with non-invasive ventilation [NIV] providing both     end-expiratory positive pressure and pressure support. However, in a recent trial by our     group, non-invasive ventialtion [NIV] was not superior over oxygen without NIV.      High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to     standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of     higher flow rates [of up to 60 L/min] via nasal cannula devices, with Fraction of inspired     oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and     constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved     breathing-effort efficiency, and higher positive airway pressures associated with better lung     recruitment.      Clinical consequences of these physiological benefits include alleviation of dyspnoea and     discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for     intubation in patients with severe hypoxemia, and decreased mortality in unselected patients     with acute hypoxemic respiratory failure However, although preliminary data establish the     feasibility and safety of this technique, HFNO has never been properly evaluated in     immunocompromised patients.      Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard)     oxygen, minimising day-28 mortality   "
41728|NCT02739438|"     The carry out a prospective cohort study of healthy volunteers, assessing differences between     baseline pulmonary inflammation, response to LPS inhalation and endothelial function, as     measured by flow mediated dilation between, electronic cigarette uses, cigarette smokers and     non smokers.   "
41729|NCT02739425|"     The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical     routine practice. On the one hand this allows evaluation of the equivalence of the two     techniques. On the other hand this ensures that patients do not experience any possible     disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as     efficient as conventional sentinel node mapping.      The programme will compare the Sentimag® with the conventional sentinel lymph node detection     with radioactive tracer combined with blue dye (in centres using the combined technique) and     thereby determine whether the new technique is equivalent to the standard technique for SLNB.   "
41730|NCT02739412|"     A common complication of organ transplantation is 'rejection' of the transplanted organ. This     occurs when the body's immune system tries to attack (or reject) the transplanted organ.      Drugs known as immunosuppressants (anti-rejection medications) are prescribed for patients     after transplantation to prevent rejection. But, anti-rejection medications are associated     with significant side effects including high blood pressure, high blood sugars, and high     cholesterol - all of which may increase the risk of heart and vascular complications.     Anti-rejection medications also increase the long-term risk of some types of cancer.      Sometimes, liver transplant patients who stop taking anti-rejection medications do not     experience rejection of their transplanted liver and the liver keeps working. These patients     are said to tolerate the transplanted liver, and this condition is referred to as     tolerance. Doctors are working to learn more about why some liver transplant patients     develop tolerance after receiving a transplant, while others do not.      Studies have shown that patients who develop tolerance have an increase in a type of immune     cell called regulatory T-cells or Tregs. This means Tregs may be important in preventing     rejection of a transplanted organ.      Studies have also shown that a human cytokine (a type of protein), called interleukin-2     (IL-2) aids in increasing the number of Treg cells in the body, and IL-2 has been given to     patients to successfully treat disorders of the immune system such as graft vs host disease -     a serious condition sometimes seen in patients after bone marrow transplantation.      The purpose of this investigation is to study if low dose IL-2, given to liver transplant     patients by subcutaneous (under the skin) injections, over a 4 week period of time, will     cause an increase in the number of Treg cells in the blood.      In addition, investigators will learn about the kinds of side effects low dose IL-2 will     cause and how severe those side effects will be.   "
41731|NCT02739399|"     In patients under general anesthesia, episodes of hypotension are often treated with     phenylephrine. The effect of phenylephrine is conventionally attributed to afterload     increase.      The aim of the study is to describe the time course of the effects of phenylephrine on the     cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive     alpha-mimetic, could be beneficial for preload optimisation.   "
41732|NCT02739386|"     The research questions to be addressed by this study are as follows:        1. What is the prevalence of ipilimumab use among adults with a history of autoimmune          disease that received treatment with ipilimumab for advanced melanoma?        2. Do melanoma patients with a history of autoimmune disease experience complications that          require hospitalization related to their underlying autoimmune disease following          treatment with ipilimumab?   "
41733|NCT02739373|"     The main purpose of this study is to measure the amount of study drug (BMS-986189) in the     blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a     single dose.   "
41735|NCT02739347|"     This study proposes to assess the effect of trans-cranial direct current stimulation (tDCS)     on cognitive control, working memory, functional, clinical, and cognitive outcomes in     schizophrenia patients.   "
41736|NCT02739334|"     The purpose of this study is to learn whether a combination of two research-proven programs,     a responsive caregiving parenting program and a childhood obesity prevention program, will     have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators     hypothesize that the children participating in the intervention will have significantly lower     BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of     fruits and vegetables, and minutes of physical activity.   "
41777|NCT02738801|"     A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase     IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety,     tolerability, PK and PD of GLPG1690. Male and female subjects aged 40 years or older will be     screened to determine eligibility. The screening period will be up to 4 weeks. At baseline,     eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo     administered for 12 weeks. The subjects will visit the study center at screening, baseline,     week 1, 2, 4, 8 and 12 and for a follow up visit 2 weeks after the last administration of     study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital     signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/BALF samples,     Spirometry, St George's respiratory questionnaire, high-resolution computed tomography     (HRCT).   "
41737|NCT02739321|"     The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To     Sleep System™ in improving the sleep quality of children with Autism Spectrum Disorder (ASD).     The Sound To Sleep System™ is a mattress foundation designed to improve sleep quality in     individuals with ASD and sleep disturbance by providing mattress vibrations that accompany     and sync with auditory stimulation. For the present study, the primary objectives are as     follows:      * SA1 - To determine whether the use of the Sound To Sleep System™ in ASD-affected children     with sleep disturbances is well tolerated as defined by group drop-out proportion due to     issues with the mattress technology.      The study will also explore the following objectives:        -  SA2 - To determine the efficacy of the Sound To Sleep System™ in improving sleep quality          as measured by parent reported sleep quality in ASD-affected children with sleep          disturbances. (Please note SA2 was changed from clinician-rated to parent-rated because          we were not able to collect clinician-rated sleep quality information).        -  SA3 - To determine the tolerability of the Sound To Sleep System™ as defined by study          drop-out due to any reason and caregiver ratings of ease of mattress technology use.        -  SA4 - To determine whether use of the mattress technology improves functioning as          defined by secondary outcome measures.   "
41738|NCT02739308|"     The aim of this study is to investigate the influence of a 12-week proprioceptive training     program on the neurofunctional control and the incidence of ankle sprains in fencing     athletes. The study will be developed in six stages: familiarization, pre intervention,     intervention, post intervention follow-up of three and six months. In the pre intervention     stage will evaluate muscle strength inverters, everter, dorsal plantar flexors and ankle     flexors through the isokinetic dynamometer; the reaction time of these muscles during Lunge     Test; neuromuscular control during the Star Excursion Balance Test and performance in Drop     Vertical Jump Test. In the intervention athletes will perform proprioceptive training for 12     weeks, three times a week, lasting 30 minutes. In the post intervention, the follow up of     three to six months will be held the same pre intervention of the tests and recording the     incidence of injuries occurred during the study. The expected result at the end of the study     is to improve all variables, increasing the performance of athletes and decreasing the     incidence of ankle sprains.   "
41739|NCT02739295|"     NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis.     This is a prospective randomized controlled trial.      Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of     G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at     admission and will be followed until 3 months after discharge.   "
41740|NCT02739282|"     The investigators aim at studying therapeutic drug monitoring of newer generation     antiepileptic drugs (AEDs) in people with epilepsy, using state of the art Ultra-performance     Liquid Chromatography coupled to Tandem Mass Spectrometry:        -  to assess the tangible benefit of individualising therapy through therapeutic drug          monitoring in term of clinical response and adverse events        -  to assess the reliability and added value of salivary therapeutic drug monitoring This          will be assessed through a randomised trial of either systematic or rescue therapeutic          drug monitoring in people requiring treatment adjustment; outcome will be assessed in          term of tolerance and treatment response in a survival analysis to assess the benefit of          systematic therapeutic drug monitoring. For each blood samples taken in those studies, a          saliva probe will be collected and its reliability ascertained retrospectively.   "
41741|NCT02739269|"     This is a prospective randomized trial to compare the use of AFC and serum AMH as the basis     for gonadotrophin dosing in in-vitro fertilization treatment.      The hypothesis is that the use of serum AMH as the criterion for determination of     gonadotrophin dosing in IVF treatment results in more optimal ovarian response than AFC.   "
41742|NCT02739256|"     The primary aim of this study is to determine if normal bladder function (the ability to     empty the bladder during spontaneous urination) after surgical repair of pelvic organ     prolapse returns faster in patients who have a retrograde voiding trial the day of surgery     versus patients who have a retrograde voiding trial on postoperative day one. Half of     participants will have a voiding trial 4 hours after surgery, while the other half will have     the voiding trial postoperative day one.   "
41743|NCT02739243|"     Background and study aims: Being a caregiver for someone with cancer can be very difficult     emotionally. For many the patient is a family member or friend, and so this can cause the     caregiver a great deal of psychological distress. There are currently very few studies     looking into the effectiveness of psychological treatments for distressed caregivers of     cancer patients. This study is looking at tailored group therapy program for carers of cancer     givers. The aim of this study is to find out whether this program can help to lower levels of     distress in cancer caregivers and help them to better cope with caring for someone with the     illness.   "
41744|NCT02739230|"     The goal of this research project is to evaluate the effectiveness of a novel treatment to     control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and     eliminate risks associated with catheters is the use of Exparel injection into the joint at     the time of surgery.   "
41745|NCT02739217|"     This is a Phase 2, single-centre, single-arm, open-label study of the safety, tolerability,     and effects on biomarkers of PBI-4050 in subjects with Alström syndrome for a treatment     duration of 24 weeks.   "
41746|NCT02739204|"     The research and development of novel anti-tumor agents in oral cancer is slow, the     investigation of repositioning use of currently available drugs in clinical, such as a     selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential     alternative strategy.   "
41747|NCT02739191|"     Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower     extremity orthopedic trauma to prevent infectious complications.   "
41748|NCT02739178|"     The study will measure the impact of sanitation access on women and girl's social and     emotional health, behaviors, and quality of life in rural India before and after a sanitation     intervention compared to a comparison group that will receive the same intervention at a     later date.   "
41749|NCT02739165|"     The purpose of this study is to assess the efficacy and safety of the intravenous drip     infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis     (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group     comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as     the primary endpoint.   "
41750|NCT02739152|"     Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation     Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately     treated cases can lead to severe sepsis or septic shock; being characterized by high     mortality and morbidity.      Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment     very difficult in particular on Emergency Department (ED) patients due to their infectious     illness background and the frequent comorbidities. Also, the severity of the condition may     not be apparent at initial contact with ED personnel: patients may arrive at ED with mild     clinical manifestation and rapidly progress to critical illness, or rather at the opposite     others have benign evolution despite a similar symptoms. In these conditions, the main     challenge of ED clinicians is differentiating mild infections from life-threatening ones in     the heavy workload of ED environment Objective of TRIAGE project is to identify and validate     biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency     Department.      Targeted population is adult patients freshly admitted at ED, whom blood samples will serve     to validate candidate markers.   "
41751|NCT02739139|"     The manufacturers of AlphaBRAIN(TM) claim that their product, when taken as directed, has     beneficial effects on cognition. The active ingredient in AlphaBRAIN, Huperzine A, is a     naturally occurring compound found in firmoss and also thought to be an acetylcholinesterase     inhibitor. Numerous clinical studies have been undertaken to investigate the effects of     Huperzine A on cognition and have demonstrated benefit to cognition in both individuals     diagnosed with neurodegenerative diseases as well as performance on academic tasks by     students. However, to our knowledge, there are no randomized controlled trials evaluating the     effects of AlphaBRAIN(TM) on cognition. Thus, the purpose of the current study is to assess     the effects of daily oral administration of AlphaBRAIN(TM) on cognitive functioning, as     compared to placebo, after 45 days of treatment.        1. To evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on the change          in a battery of standardized neuropsychological tests (see attached).        2. A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo          given orally on sleep.   "
41793|NCT02738593|"     third generation of EGFR-TKIs is the newest target therapy for NSCLC. However, we did not     known the specific mechanisms for those non-responders and patients grow resistance.Next     generation sequencing is current the most sensitive and specific method to exam gene     mutation, diversion etc.      By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and     resistance.   "
41752|NCT02739126|"     Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous     origin is of utmost importance. Due to it's markedly favourable safety profile, a     bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a     meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in     comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success     rate), is sub-optimal.      There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe     (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be     advanced more peripherally to obtain a biopsy.      Therefore identifying what type of USS probe is better for a given PPL will aid in improving     the diagnostic yield.      In this study, investigators compare these two types of probes in the ability to diagnose a     PPL.      The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS     arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too     small to accommodate an aspiration needle)   "
41753|NCT02739113|"     Earlier protocol for cultivated oral mucosal epithelial transplantation (COMET) requires     trypsin/EDTA to isolate epithelial cells from tissue, and uses murine 3T3 cells as feeder     cells, which results in biosafety concern. This study uses collagenase instead of     trypsin/EDTA to isolate epithelial cells, and does not use 3T3 cells co-culture, so as to     make an animal ingredient-free cell culture product. The purpose of the study is to evaluate     the feasibility of the new protocol of COMET in clinical use.   "
41754|NCT02739100|"     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via     hemodialysate and via two different intravenous routes in adult patients with chronic kidney     disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.   "
41755|NCT02739087|"     Currently catheters used in heart catheterization procedures are guided throughout the heart     chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to     radiation. With this study protocol the investigators will use MRI technology to take     real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic     energy; therefore, it does not expose participants to radiation energy.   "
41756|NCT02739074|"     Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal or     gastric) has become a standard technique validated. The rate of high technical and clinical     success (76 to 91% in 3 months) and the lower morbidity in the literature explains that     validation. However this treatment is done at the cost of a higher median number of treatment     sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and potentially     high costs. The constant improvement of therapeutic endoscopy equipment was allowed to see     the advent of metal prosthesis completely covered by a membrane allowing them endoscopic     extraction with ease. It has thus been recently developed short prostheses, of large diameter     (up to 15/16 mm), with broad flange (or stent diabolo) to be considered for use in the     drainage of digestive peri collections. Few studies respectively determined the effectiveness     of this type of prosthesis in the drainage of peri digestive collections Under echo endoscopy     and treatment of necrosis of pancreatic origin. The purpose of this work is to evaluate     multicenter prospective clinical and technical efficiency of laying completely covered stent     diabolo in echo endoscopy for the treatment of necrosis of pancreatic origin.   "
41778|NCT02738788|"     The goal of this study is to track the intraoperative changes that occur in the airways of     patients undergoing 1) laparoscopic surgeries in the Trendelenburg position, and 2) spinal     surgeries in the prone position, as well as the regression of these changes postoperatively.     These surgeries are known to cause edema and swelling of the soft tissues of the head and     neck, temporarily worsening airway anatomy, but there is little data quantifying these     changes, and no studies have investigated the time course required for the airway to return     to its baseline after extubation. This would be important clinical information given that     airway management is always a major concern perioperatively. The investigators will test     hypotheses by evaluating patients' airways preoperatively, immediately post-extubation, and     at regular intervals thereafter using the Modified Mallampati Score class (MMS), in which a     patient's airway is scored from class 1 to 4 (in which 4 indicates the highest likelihood of     a difficult intubation) based on the visibility of the soft palate, uvula, and faucial     pillars inside the oral cavity.   "
41757|NCT02739061|"     This study intends to explore the pathogenesis of obsessive-compulsive disorder(OCD) by using     biological technologies such as genetics and imaging, and to evaluate the efficacy of group     cognitive behavioural therapy in OCD among the Chinese people. We also prepare to explore the     synergistic effect of the pharmacological treatment combined with group cognitive behavioural     therapy in OCD, and to find the biological and psychological index which can predict curative     effect.      This research includes case control study and randomized controlled single-blind study. At     baseline, we compare the dimensions of clinical symptoms, genetics and imaging between OCD     patients and healthy controls. The OCD patients are randomly assigned into pharmacological     treatment, psychological treatment or pharmacological combined with psychological treatment     for a 12-week treatment. After a 12-week treatment, the OCD patients will be divided into     valid and invalid groups according to the results of our randomized controlled study by     researchers: to our valid group, patients will continue the current treatment, and to the     invalid psychological or pharmacological treatment group, patients will have a 12-week     combined treatment. From the baseline, we will have a 9-month follow up for both OCD patients     and healthy controls.   "
41808|NCT02738398|"     Prospective study of the effects of image acquisition and reconstruction parameters on     accuracy of FDG PET/CT mediastinal nodal staging in NSCLC   "
41809|NCT02738385|"     Several studies have shown relationship between exercise intensity and improvement     cardiometabolic health. It has been suggested that high intensity interval training and also     moderate training generate positive effects on metabolic risk factors. For these reasons, it     is necessary to clarify which type of training, is more effective to improve cardiometabolic     health in latinamerican population.   "
42038|NCT02735382|"     This study is designed to assess whether completely electronic, HIPAA-compliant, EHR-based,     closed-loop referrals for tobacco cessation from primary care clinics to a state telephone     tobacco quitline service can increase the number/percentage of adult tobacco users receiving     evidence-based tobacco dependence treatment when compared to paper-based fax referrals.   "
41758|NCT02739048|"     1. The overall objective of the study: By evaluating the curative effect of CSAP in localized     prostate cancer, locally advanced prostate cancer and metastasis advanced prostate cancer,     and the change of state in cellular immunity and humoral immunity before and after CSAP.     Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as the     change of immune status before and after CSAP.      2. The main content of the study:        1. Included in the samples are patients in hospitals for CSAP. The sample capacity are          planned to be 80. The main purpose of the study is to observe the overall survival rate          , disease free survival rate, the progress time of the PSA biochemical recurrence as          well as the disease progress time.        2. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T,          CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after          cryoablation within 1 month, 3 months and 6 months.        3. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio          (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the          activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2 weeks          and 1 month.        4. Before cryoablation, detect the expression and distribution of Follistatin-Like1          (FSTL-1), Besides, verify the connection between the number and activation ratio of          tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on          the immune response.   "
41759|NCT02739035|"     Compare the outcome following manipulation under anesthesia for stiffness in a randomized     controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time     of manipulation to a control group receiving manipulation alone.      Outcomes will include pain, range of motion, as well as subjective outcome scores.   "
41760|NCT02739022|"     This is a pilot study designed to test feasibility of a psychotherapeutic intervention for     the critically ill patients in intensive care units. Intervention is named Early     Psychological Support for the Critically Ill (EPSCI)   "
41761|NCT02739009|"     This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for     the assessment of safety, tolerability and pharmacokinetics of single ascending doses of     MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to     severe atopic dermatitis.   "
41762|NCT02738996|"     Type-2 diabetes, a common non-infectious disease, is the result of impaired insulin function     and insulin production in the body. In type-2 diabetic patients, postprandial glucose     control, lipid control and reduction of insulin resistance are crucial to deter the     development of diabetes related complications (e.g. retinopathy, nephropathy, neuropathy and     cardiovascular diseases), pancreatic β cells failure, morbidity and mortality. Currently,     diet, exercise and standard oral medicines are used to treat type-2 diabetes. However,     providing the most effective treatment to control postprandial glucose and lipid; and to     preserve the pancreatic β cells is challenging because poor metabolic profiles are still     detected in type-2 diabetic patients. Therefore, understanding the factors influencing the     poor metabolic profiles and adjunct therapy to manage type-2 diabetes are really important to     tackle this disease.      In modern society, people are spending most of their waking time in sedentary behaviour,     which is primarily prolonged sitting. Prolonged sedentary time is associated with increased     postprandial glucose, lipid and insulin resistance. In contrast, frequent interruption of     prolonged sitting with short light activity break reduces postprandial glucose, triglyceride     cholesterol and insulin resistance. However, how frequently patients should interrupt     sitting, potential longer-term effect of short activity break on reduction of postprandial     glucose, triglyceride cholesterol and insulin resistance, and the knowledge, beliefs and     experiences on the use of technology to decrease sedentary behaviour and improve glycaemic     control are not investigated in type-2 diabetic patients. Therefore, it would be relevant to     investigate this to prove the therapeutic role of frequent short activity break in sedentary     time in the management of type-2 diabetes.      Primary Research Objective:        1. To investigate the dose-response effect of frequency/number of light intensity walking          breaks of sitting on postprandial glucose, insulin, C-peptide and triglyceride          cholesterol level.        2. To investigate the potential longer-term effect of light intensity walking breaks of          sitting on glucose control using 24-h glucose data.      Secondary Research Objectives: The secondary objectives are        1. To obtain data to inform the development of a future feasibility trial investigating the          feasibility, compliance, adherence and longer-term effect of different frequencies of          light intensity walking breaks in sitting time on glycaemic excursions in free-living.        2. To explore the knowledge, beliefs and experiences of those with Type 2 diabetes on the          use of technology to decrease sedentary behaviour and improve glycaemic control, that          could be used in the feasibility trial   "
41763|NCT02738983|"     Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small     cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability.     Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors     (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic     radiotherapy has also been evaluated in several phase II trials. The aim of study is to     investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type     EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.   "
41764|NCT02738970|"     This study involves a two-part design. Part 1 is designed to determine the optimal dose of     subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable     exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be     compared using a compilation of pharmacokinetic (PK) parameters such as area under the     concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum     concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm     the dosing regimen in women with EBC on the basis of safety, tolerability, and PK     assessments.   "
41765|NCT02738957|"     Few studies have investigated breastfeeding in twins, and none have addressed the effect of     antenatal counseling on breastfeeding twins.The purpose of this study is to investigate the     effect of antenatal breastfeeding counseling on the breastfeeding rates in twin pregnancies.   "
41779|NCT02738775|"     This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in     patients with relapsing forms of multiple sclerosis   "
41766|NCT02738944|"     Background: Community Health Centers care for over 20 million rural, low income and minority     Americans every year. Patients often have complex mental health problems such as     Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers     located in rural areas face substantial challenges to managing these patients due to lack of     onsite mental health specialists, stigma and poor geographic access to specialty mental     health services in the community. As a consequence, many rural primary care providers feel     obligated, yet unprepared, to manage these disorders, and many patients receive inadequate     treatment and continue to struggle with their symptoms. While integrated care models and     telepsychiatry referral models are both promising approaches to managing patients with     complex mental health problems in rural primary care settings, there have been no studies     comparing which approach is more effective for which types of patients. Objectives: The     central question examined by this study is whether it is better for offsite mental health     specialists to support primary care providers' treatment of patients with PTSD and Bipolar     Disorder through an integrated care model or to use telemedicine technology to facilitate     referrals to offsite mental health specialists. We hypothesize that patients randomized to     integrated care will have better outcomes than patients randomized to referral care. Methods:     1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be recruited     from Community Health Centers in three states (Arkansas, Michigan and Washington) and     randomized to the integrated care model or the referral model. Patient Outcomes: Telephone     surveys will be administered to patients at enrollment and at 6 and 12 month follow-ups.     Telephone surveys will measure access to care, therapeutic alliance with providers,     patient-centeredness, patient activation, satisfaction with care, appointment attendance,     medication adherence, self-reported clinical symptoms, medication side-effects, health     related quality of life, and progress towards life goals. A sub-sample of patients will be     invited to participate in qualitative interviews to describe their treatment experience using     their own words. Likewise, primary care providers will be invited to participate in     qualitative interviews to voice their perspective.   "
41767|NCT02738931|"     Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other     antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1)     infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by     many patients and offer the potential for increased patient adherence and consequently a     reduced likelihood of virological failure and viral resistance.      The purpose of the present study is to evaluate the relative bioavailability of two     experimental FDC tablets of DTG and 3TC relative to co-administration of the single entity     products in healthy adult subjects.      This study will be conducted as a randomized, open label three-way, crossover design with 6     treatment sequences in approximately 30 subjects. Each subject will have a screening visit     within 30 days prior to the first dose of study drug, three treatment periods each with a     single dose of study drug and a follow-up visit within 7-14 days after the last dose of study     drug. There will be at least 7 days washout between dosing periods. The total duration of     participation of a subject in this study will be approximately 9 weeks.   "
41768|NCT02738918|"     BACKGROUND: Antibody-mediated humoral rejection is currently a critical question in renal     transplant recipient with immunological risk factors such as pre transplant donor-specific     anti HLA antibodies (DSA). The immunosuppressive management of the patients is still not well     defined and improving both short and long-term graft outcome remains a challenging question.     Recent experimental data suggest that Belatacept could induce B cell anergy , induce     regulatory B cell and decrease Ig production. These findings are strengthened by the results     of both phase II and III clinical studies, showing a significant lower incidence of DSA in     patients treated with Belatacept compared to recipients receiving a conventional     immunosuppressive regimen with calcineurin inhibitors (CNI).      Primary objective will be the incidence of clinical and subclinical humoral rejection     (According to BANFF 2011 Criteria). Secondary objectives will include one-year graft and     patient survival, renal function at M12 (MDRD), incidence of cellular rejection (M 12), level     of proteinuria (M3 and M12) and DSA outcome (outcome of DSA MFI at JO, M3 and M12). Inclusion     period will be of two years. DSA identification and quantitative analysis before and after     transplantation will be centralized in only one HLA laboratory Unit (Hospital Saint Louis)     for providing results homogeneity.      According to previous clinical studies, the incidence of Acute Antibody Mediated Humoral     Rejection is close to 20% in patients with mild immunological risk defined by the presence of     DSA at the time of transplant with mean fluorescence intensity (MFI) between 1000 and 3000     (Luminex). In order to demonstrate a significant reduction (40%) of AAMR and sAAMR incidence,     91 patients will be included in this study. Results will be compared to a cohort matched for     age, sex, immunological risk factor (DSA), time of transplant, transplant center and grafted     with a similar immunosuppressive regimen including CNI instead of Belatacept   "
41769|NCT02738905|"     The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide     (TMAO) levels in patients with end-stage renal disease.   "
41770|NCT02738892|"     This prospective non-intervention cohort study will enroll women in the first or early second     trimester of pregnancy and follow them through delivery and 42 days postpartum.      Infants will also be followed until 42 days after delivery. Detailed medical and obstetrical     information will be collected, as well as biological samples, in order to better elucidate     the biological mechanisms leading to preterm delivery among Zambian women, in an effort to     identify new strategies for prevention.   "
41772|NCT02738866|"     This study is being done to look at the role of continuing palbociclib treatment in     combination with another type of hormonal therapy (fulvestrant) after disease progression of     palbociclib in combination with an aromatase inhibitor.   "
41773|NCT02738853|"     The study objective is to evaluate safety and efficacy of the Medtronic TAVR 2.0 system in     patients with severe symptomatic aortic stenosis who are considered at high through extreme     risk for surgical aortic valve replacement   "
41774|NCT02738840|"     A post market study evaluating the St Jude medical MR conditional neurostimulation systems.   "
41775|NCT02738827|"     Laser treatment of pTa low grade bladder tumours in the outpatient department      Number of Subjects/Centres Planned: 20 patients will be included in this study. The study     will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen,     Denmark.      Primary Objective: To show that small pTa bladder tumours safely can be removed with diode     laser in an outpatient department Secondary Objective: To evaluate the patients experience     with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale     Score (pain evaluation).   "
41776|NCT02738814|"     This study aimed to verify the effects of propofol for treatment on emergence agitation (EA)     after sevoflurane anesthesia in pediatric strabismus surgery.   "
41790|NCT02738632|"     Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of     Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with     Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by     Telmisartan/Amlodipine Combination   "
48119|NCT02655770|"     The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective     in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac     MRI. Secondary if the treatment has any effect on the perfusion of the heart on a     cardiac-MRI.   "
41780|NCT02738762|"     Earlier studies showed a benefit in survival when glutamine was given intravenously and these     studies lead to recommendations that glutamine should be given to critically ill patients.     The ESPEN guidelines recommend 0,2-0,4 g/kg/d intravenous glutamine added to standard     parenteral nutrition .      Until recently it was not possible to obtain a plasma glutamine level fast enough to consider     the result for clinical decision making. With the availability of a Point of Care (POCT)     measurement of plasma glutamine level a measurement can be performed short after the     collection of blood. This offers the possibility to identify a patient with a low plasma     glutamine level shortly after admission and use repeated measurements for evaluation of the     response to supplementation of glutamine.   "
41781|NCT02738749|"     Congestive heart failure (CHF) represents a major health care concern in the United States.     Currently, risk stratification of sudden cardiac death and the need for implantable     cardioverter-defibrillator (ICD) placement are essentially dependent upon assessment of left     ventricular ejection fraction (LVEF). Nevertheless, the predictive value of LVEF is     suboptimal, alternative testing for risk assessment for the development of sudden cardiac     death in the heart failure population is desirable.      At the genome level, the investigator has focused on the role of SCN5A gene mutations in     arrhythmogenesis. Lymphocyte SCN5A mRNA processing may serve as a surrogate marker to assess     SCN5A function at the cardiac level and may correlated with arrhythmic risk in high risk     populations. This study will determine if SCN5A variant levels are predictive of appropriate     ICD therapies in patients with a newly implanted ICD.   "
41782|NCT02738736|"     Hypertension is a leading risk factor for cardiovascular disease (CVD) globally, accounting     for 25-35% of the population-attributable fraction. Sodium (salt) intake is a key determinant     of blood pressure, and reducing sodium intake has emerged as an important target for     population-based interventions to prevent CVD. However, there is considerable uncertainty     about the optimal level of sodium intake that is associated with lowest CV risk, and whether     optimal levels differ for different populations and individuals. International and national     guidelines recommend low sodium intake (<2.3g/day, or lower) in all persons, and advocate a     population-wide approach to reducing sodium. Most of the world's population (~95%) consume     between 3 and 6g/day of sodium (mean intake 4.0g/day), which means that most people will     require a major change to their diet, to achieve the guideline target (<2g/day). While there     is convincing evidence that high sodium intake (>5g/day) is associated with an increased risk     of CVD, compared to low or moderate intake, the evidence that low sodium intake (<2.0g/day)     is associated with a lower risk of CVD than moderate intake (2.0-5g/day) is inconsistent and     inconclusive. The investigators plan to conduct a Phase IIb clinical trial to evaluate the     role of low sodium intake (versus moderate) on cardiovascular biomarkers.   "
41783|NCT02738723|"     As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the     aim of this study is to evaluate the efficacy and safety of stereotactic body radiation     therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP     regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung     cancer   "
41784|NCT02738710|"     This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between     infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy   "
41785|NCT02738697|"     Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second     leading cause of cancer-related death. Surgical resection is still the main radical approach     for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further     improvement of prognosis of HCC patients. The conventional risk factors of recurrence     including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the     microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after     hepatectomy. The investigators' previous study showed that the recurrence rate is more than     50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only     independent risk factor for the overall and disease-free survival of HCC patients in multiple     variables analysis. It is important to reduce the recurrence and prolong the survival of     patients after hepatectomy with effective adjuvant therapy. Reported at 2014 American Society     of Clinical Oncology (ASCO) annual meeting, A phase III randomized, double-blind,     placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent     recurrence of hepatocellular carcinoma (STORM trial) failed to meet the primary     endpoint-recurrence free survival (RFS). Given the inspiring result of a recent trial, which     compared with single agent of doxorubicin, the oxaliplatin-containing regimens (FOLFOX)     showed significant improvement in OS, objective response rate (ORR) and disease control rate     (DCR) in Asian (especially China) HCC patients. Based on these rationales, the investigators     design the current prospective randomized clinical trial to evaluate the effect of adjuvant     chemotherapy with FOLFOX to prolong the overall survival and reduce the recurrence in HCC     patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant     follow-up.   "
41786|NCT02738684|"     This project aims to do a small sample exploratory study, to predict EGFR-TKI targeted     therapy gefitinib' s efficacy in late stage lung adenocarcinoma patients (phase IIIB or IV),     who have negative tissue EGFR gene mutation, positive plasma free nucleic acid EGFR gene.   "
41787|NCT02738671|"     The purpose of this study is to explore the relationship between diabetes and cognitive     impairment by olfactory function assessment and functional MRI.   "
41788|NCT02738658|"     Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with     metallic stent implantation remain with effort angina despite optimal medical treatment and     absence of stent restenosis at 1 year. The most plausible cause of persistent effort angina     after stent implantation is microcirculatory dysfunction. Coronary circulation matches the     myocardial blood supply and oxygen consumption. Metallic stent implantation has been related     with endothelial dysfunction and impaired coronary blood flow reserve (relation between     coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year.      Bioresorbable Vascular Scaffold (BVS) has been shown to improve the endothelial function and     to improve the angina symptoms at 1 year. However, the coronary blood flow of BVS has never     been tested.      Main objective: To determine differences in the blood average peak velocity at maximal     hyperemia with adenosine infusion between patients treated with bioresorbable and metallic     coronary stents at 1 year after stent implantation.      Methodology: A total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent     (EES) versus everolimus-eluting BVS implantation in patients with stable coronary disease. At     1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor drugs.     A pressure/Doppler wire is advanced distally to the treated segment and the endothelial     (acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor function is     assessed with quantitative coronary angiography and pressure and Doppler measurements. Angina     test questionnaires are obtained at different time-points of the study.      Expected results: A difference between patients treated with BVS and EES of 12.0 cm/sc in the     maximal average peak velocity (APV) under maximal hyperemia (with adenosine administration)     is expected, as assessed by Doppler measurements, at 1 year after stent implantation. The     study is powered to assess superiority in terms of maximal APV favoring patients treated with     BVS.   "
41799|NCT02738515|"     The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the     effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing     (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo     gel alone in patients with chronic periodontitis (CP).   "
48120|NCT02655757|"     This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor,     on Progression of Coronary Intermediate Lesion.   "
41791|NCT02738619|"     Vitamin D as adjuvant to subcutaneous specific immunotherapy in patients with allergic     rhinitis Specific allergen immunotherapy is the treatment of choice for patients with     persistent allergic rhinitis. Some strategies to accelerate immunological and clinical     changes to ensure an early response and improve adherence are needed. The administration of     vitamin D along with conventional treatments in allergic patients with asthma or atopic     dermatitis, pathophysiological entities like allergic rhinitis, reduces the severity of     symptoms in less time.      Primary endpoint. To evaluate the efficacy of vitamin D in terms of reducing the time of     therapeutic response to subcutaneous specific allergen immunotherapy.      Compare the time of clinical improvement and adherence to treatment among the group receiving     vitamin D against the group receiving placebo Analyze the relationship between vitamin D     values, total serum IgE, serum eosinophil and nasal cytology in both groups before and after     treatment Assess the safety of vitamin D by serum calcium. TH17 and Treg quantify cells     before and after treatment. MATERIAL AND METHODS This is a interventional, prospective     clinical trial randomized placebo-controlled, double-blind study including paediatric     patients (children 3-12 yr old) with allergic rhinitis, with parallel group: Immunotherapy +     Placebo and Immunotherapy + Vitamin D. Patients prior informed consent include more patients     being female and male of 3 to 12 years old. They will be randomized and in the same     proportion. The sample was calculated using the G Power program to achieve an effect size of     0.65, with alpha = 0.05, statistical power = 80% and 20% losses to mean difference of 2     independent groups, the result was 80 patients, 40 per group. Monitoring will be conducted at     0, 3 and 6 months, assessing clinical and laboratory parameters with the questionnaire RQLQ,     TNSS, CARACT KIDS, ARIA, GINA.      ANALYSIS It will be analyzed in SPSS. The results are expressed by descriptive statistics.     For comparison of means will be used t student. It will be analyzed with ANOVA, variance for     repeated measures in time, general linear model, structural equations, multivariate analysis,     analysis of the main components. P values <0.05 were considered statistically significant.   "
41792|NCT02738606|"     The goal of this clinical research study is to compare the effect of having liver resection     with standard of care chemotherapy to having standard of care chemotherapy alone in patients     whose colorectal cancer has spread to their liver and lungs.   "
41794|NCT02738580|"     Serum concentrations of the different hormones involved in follicular steroid genesis during     a cycle of controlled ovarian stimulation with recombinant FSH or HMG will be compared in     this study. Serum Progesterone (P) levels at the end of Controlled Ovarian Stimulation (i.e.     the day of triggering) have been related to cycle outcome, in terms of ongoing pregnancy and     live birth rates. Large cohort studies show that P levels above a certain threshold are     associated with poorer cycle outcome. The mechanisms behind P elevation are not well     understood yet. It has been shown that P levels are positively related to ovarian response     and to the dose of FSH given during COS. Furthermore, it has been well documented that P     levels at the end of stimulation are significantly higher when recombinant (r) FSH is used     for COS when compared to HMG, either in a GnRH agonist long protocol or in a GnRH antagonist     protocol. Some authors suggest that this finding is explained by the fact that COS with rFSH     provides a higher oocyte yield than when hMG is given, so the higher P levels observed would     be explained by the larger number of follicles developed when rFSH is used. On the other     hand, other authors explain this event by a different follicular esteroidogenesis when HMG is     used for COS compared to rFSH The hypotheisis behind this assumption is that rFSH enhances P     synthesis from its precursor pregnenolone in the granulosa cells. This P is unable to be     further metabolized into androgens because of the lack of 17-20 lyase in the human granulosa     cells, and therefore is delivered into circulation. On the other hand, when HMG is given for     COS, the ∆4 pathway is promoted, and pregnenolone will be catabolized in to     Dehidroepiandrostenodione (DHEA), in the theca cells, and this one to Androstenodione, which     will be finally aromatized in to estrogens. This mechanism will explain the lower P and     higher E2 levels observed in HMG cycles in comparison to rFSH cycles.   "
41795|NCT02738567|"     The use of vasopressor supplement materials to local anesthetics is commonly used in     procedures in various fields of dentistry, ENT (ear, nose, and throat), Plastic Surgery, Hand     surgery and gastroenterology. Epinephrine is used to constrict small blood vessels, thus     reducing bleeding during a medical procedure, reducing the toxicity by reducing systemic     absorption of local anesthetic, and prolonging the duration and intensity of neural blockage     created by the local anesthetic.      There are descriptions in the literature of cases in which the use of lidocain and adrenaline     caused adverse cardiac events such as arrhythmias, edema and increase in blood pressure     during ENT and dentistry procedures. As far as we know there has never been a systematic     examination of the incidence and severity of arrhythmias during procedures with local     anesthesia.      The purpose of the study:        1. To examine the prevalence and types of arrhythmias in patients undergoing a medical          procedure performed under local anesthesia        2. Examine whether adding adrenaline to the local anesthetics affects the incidence of          arrhythmia Determining the prevalence and types of arrhythmia will help determine the          need for monitoring and type of monitoring required during procedures under local          anesthesia.      The patients:      500 patients undergoing surgery or a medical procedure in which a local anesthetic is used at     Meir Hospital. Patients with a medical history of known cardiac arrhythmia will not be     included.      Methods:      Patients will undergo the medical procedure prescribed for them, using local anesthesia with     or without adrenaline, at the discretion of the surgeon, in accordance with the usual routine     being applied nowadays. The amount and type of anesthesia used will be registered. In     addition to the routine monitoring that is currently performed (blood pressure cuff and     non-invasive blood oxygen saturation) a continuous ECG monitoring device will be connected     prior to the beginning of the surgical procedure, until the patient is discharged from the     recovery room. The ECG monitoring results will be analyzed to detect arrhythmia. Side effects     being reported by patients (palpitations, dizziness, fainting, CPR {cardiopulmonary     resuscitation} ) will be recorded. In cases that an arrhythmia is detected, the type of     arrhythmia and the presence of clinical symptoms will be investigated.   "
41796|NCT02738554|"     Treatment cessation in chronic hepatitis B is associated with high rates of disease relapse.     However patients who achieve the seroclearance of hepatitis B surface antigen (HBsAg) (<0.05     IU/mL) show good off-treatment durability after treatment cessation. Through the     quantification of HBsAg, the study aims to investigate how low should quantitative HBsAg be     before once can achieve successful disease control after treatment cessation.   "
41797|NCT02738541|"     The purpose of this study was to determine the anti-calculus effect of dentrifice containing     5% sodium pyrophosphate and potassium pyrophosphate in a triple-mask placebo controlled     randomized clinical trial.   "
41798|NCT02738528|"     Parkinson's disease (PD) is characterized by dopaminergic neurons degeneration of the     substantia nigra, in the midbrain, resulting in the presence of motor disorders, such as     tremor, rigidity, bradykinesia, and postural instability. Researches have shown that mental     rehearsal in learning motor skills through mental practice (MP), which associates the     physical practice to somatosensory imagination to action, causes positive effects in several     motor tasks, such as the speed of motion, muscle strength performance and accuracy. Thus,     this study aims to report the effects of MP as a tooth brushing training strategy in people     with Parkinson's disease. This project was approved by the Ethics Committee in Research with     Human beings of UFPE and attempt to compare the presence of bacterial biofilm before and     after 8 weeks of brushing through the mental practice training, based on O'Leary's index. The     sample consisted of 35 people, divided into two groups: Intervention Group consists of 17     people with Parkinson's, in stages I to III of the disease, who underwent brushing     orientation associated with PM, and the control group people without the disease, who     received only orientation brushing. Then, the data were evaluated by factorial ANOVA 2x2 and     post hoc Tukey test considering p <0.05. It was observed that after the intervention was a     significant improvement of the control dental biofilm.   "
48140|NCT02655497|"     The purpose of this study is to determine the effectiveness of cognitive strategies in     improving participation in daily activities within older adults who report subjective     cognitive decline.   "
41803|NCT02738463|"     Intrauterine growth restriction ( IUGR )is defined as fetal growth slower than the normal     growth potential of a specific fetus because of genetic or environmental factors. Recently     several studies have highlighted the role of many biomolecules as markers for IUGR.     Measurement of maternal serum ferritin has also been used as a predictive marker for     increased risk of IUGR. Iron deficiency has its known deleterious effect in pregnancy but     iron loading may be associated with oxidative damage to cells and tissues. It has been shown     in various studies that lower level of transferritin receptor expression in placenta is     associated with preeclampsia and IUGR. This can lead to decrease extraction of iron by     placenta from maternal serum leading to increase maternal serum ferritin. This fetal iron     deficiency leads to increase in fetal corticotropins and fetal cortisol, causing inhibition     of fetal growth   "
41804|NCT02738450|"     The purpose of this study is to test in adults with Down Syndrome the safety, tolerability     and immunogenicity of a vaccine, ACI-24.   "
41805|NCT02738437|"     The aim of this study was to investigate the beneficial effect of bone cement in combination     with wire cerclage on the stability of the sternum following median sternotomy.      One half of the patients received only wire cerclage the other both bone cement and wire     cerclage.   "
41806|NCT02738424|"     Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone     marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in     normal bone marrow, called apparent diffusion coefficient (ADC). Histological and technical     factors appear to be the cause, but the possible influence of the employed post-processing     software has never yet been evaluated. The purpose of this study is to determine if there is     variability in lumbar bone ADC related to the post-processing software.   "
41807|NCT02738411|"     The main objective of this research is to study the links between changes in the intestinal     microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and     the presence / absence of a TH1 immune status at 36 months of age.   "
41810|NCT02738372|"     Background: Shoulder pain is the third most common musculoskeletal condition presenting to     physicians or physiotherapists ) in primary healthcare after low back and neck pain being a     significant cause of morbidity and functional disability in both working and general     population. Despite the large group of individuals seeking for primary care services, about     50% of patients with shoulder pain still report persistent pain after 12-18 months. As a     result, socio-economic burdens are considerable due to extensive use of heath care services,     sickness absence, disability pension, and loss of productivity as well as, patient´s     suffering.      Aims: the primary aim of this study was to evaluate what biopsychosocial factors predict a     better and/or poor outcome in patients with Chronic shoulder pain. The secondary aim was to     analyze the role of central sensitization in predicting a better and/or poor outcome in     patients with Chronic shoulder pain.      Hypothesis:        1. A high level of physical inactivity, kinesiophobia, fear avoidance and pain          catastrophizing and low level of self-efficacy will ease the perpetuation of Chronic          shoulder pain.        2. The presence of central sensitization will predict a poor outcome in patients with          chronic shoulder pain.   "
41811|NCT02738359|"     Efficacy of colonoscopy, colon capsule and fecal immunological test for colorectal cancer     screening, in first degree relatives of patients with colorectal neoplasia: a prospective     randomized study.   "
41812|NCT02738346|"     The purpose of this study was to determine prospectively in all patients with SCLC in second     line therapy that progression-free survival with the expected reintroduction of platinum /     etoposide is greater progression-free survival in the standard arm (topotecan ) in patients     who have relapsed at least three months after initial chemotherapy with platinum-etoposide   "
41813|NCT02738333|"     This study will evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir     (LDV/SOF) fixed-dose combination (FDC) and the safety and tolerability of LDV/SOF FDC and     sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 HCV (hepatitis C     virus) infection.   "
41814|NCT02738320|"     The purpose of this study is to develop a consumer friendly web-based interface between     Nursing Home Compare (NHC) and an e-coaching/decision-aid tool (NHCPlus) and determine if use     of NHCPlus facilitates and enhances access to and use of NHC.   "
41815|NCT02738307|"     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,     acclimatization and re-exposure to high altitude on global cognitive function.   "
41816|NCT02738294|"     The aim of the present study was to assess whether it was necessary to conduct magnifying     endoscopy with narrow band imaging (ME-NBI) targeted biopsy compared with endoscopic forceps     biopsy (EFB) from white light endoscopy in diagnosing early gastric cancer (EGC). Meanwhile,     the investigators proposed the most cost-effective way to diagnose EGC.   "
41817|NCT02738281|"     The purpose of this study is to advance understanding of the natural history of Rett syndrome     (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including CDKL5, FOXG1,     and individuals with MECP2 mutations who do not have RTT including the range of clinical     involvement and to correlate genotype-phenotype over a broad spectrum of phenotypes. While     much has been learned about RTT, improvements are required in understanding the role of     factors such as X chromosome inactivation, genetic background, and others including the     environment, on the great variability observed even between individuals with the same MECP2     mutation. These data will be essential to the development and conduct of clinical trials that     are anticipated from ongoing studies in animal models for RTT. This study will not include     clinical trials, but should set the stage for such trials and other translational research     projects (e.g., development of biomarkers).   "
48616|NCT02649270|"     The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for     psoriasis in India. The first trial in China is to evaluate the tolerability, safety,     pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with     psoriasis.   "
41818|NCT02738268|"     Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the     treated area, also known as radiodermatitis (RD).      Currently, there is a wide variety of strategies to manage RD, including creams, gels,     ointments, wound dressings. However, up to now, there is still no comprehensive,     evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a     promising, non-invasive technique for treating RD. In a recent study conducted in our     research group, LLLT prevented the aggravation of RD and provided symptomatic relief in     patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the     first prospective study investigating the potential of LLLT for RD. In the current study, we     want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in     head and neck cancer patients.   "
41819|NCT02738255|"     Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and     obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth     breathers. Research indicates that nasal breathing not only may improve sleep apnea but it     also increases circulation, blood oxygen, and carbon dioxide levels, slows the breathing     rate, and improves overall lung volumes. Thus, the investigators will test whether a     single-use Varnum mouthpiece can improve pharyngeal collapsibility and OSA severity in mouth     breathers.   "
41820|NCT02738242|"     The Novus system intended to provide ankle dorsiflexion and knee flexion or extension in     individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury     or disease. The primary objective of the study is to evaluate the usability of the Novus     system among these patients and to gain subjects' feedback regarding the device when used on     a daily basis.The secondary objective is to obtain information about the performance of the     system as a gait assistive device and to evaluate the subject's Quality of Life while using     the system.   "
41821|NCT02738229|"     Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this     are dehydration, pain and hospitalisation. The objective of this randomized controlled trial     is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms     associated with acute herpes gingivostomatitis in children. This study will involve 80     children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days.     The primary outcome measure will be the duration (in days) of feeding and/or drinking     difficulties.   "
41823|NCT02738203|"     For both intrauterine device (IUD) insertion and endometrial biopsies (EMB) currently there     are no standardized clinical guidelines for pain management. The investigators aim to explore     whether adequate pain relief is possible through self-administered, non-invasive means alone.     Reducing pain associated with IUD insertion and/or EMB may benefit patients and providers.     When patients are comfortable during their procedure, it is likely the provider can more     quickly and with fewer complications perform the insertion and/or EMB. The investigators     propose to explore the effect of a locally applied vaginal lidocaine gel in place of the     standard of care pain management, no intervention, prior to IUD insertions, and EMB.      They hypothesize that lidocaine gel is superior to placebo at decreasing procedural pain at a     variety of time points throughout the procedure. This is a superiority, blinded, randomized     controlled trial.   "
41824|NCT02738190|"     This is a randomized controlled trial that compares two different priming composition     (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under     10 kg of weight. The two approaches are both employed at the moment but there is actually no     evidence on the superiority of one over the other. This study is aimed to test the hypothesis     that Albumin is superior to fresh frozen plasma in terms of minor bleeding and transfusional     requirements.   "
41825|NCT02738177|"     Ninety healthy pregnant women candidate for surgical evacuation after confirming 1st     trimester pregnancy loss were enrolled in the study. They were randomized in three groups;     misoprostol group in which 30 candidates were receive 2 tablets of misoprostol (i.e. 400 ug)     4 hrs prior to surgical evacuation, Effox group in which 30 candidates were received 2     tablets of Effox (i.e 40 mg) 4 hrs prior to surgical evacuation & combination therapy group     in which 30 candidates were received 1 tablets of misoprostol 200ug & 1 tablets of Effox 20     mg 4 hrs prior to surgical evacuation. For all participants, the route of administration was     the intravaginal route 1ry outcomes included cervical consistency & dilatation immediately     before the procedure. 2ry outcomes included total duration of the operation and the     occurrence of drug-related side effects   "
41826|NCT02738164|"     Investigators aim to evaluate the SEPSIS 3 criterion for sepsis and septic shock in a     prospective manner.      Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population     of emergency patients with infection   "
41827|NCT02738151|"     Primary Objective:      To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated     hemoglobin (HbA1c) change.      Secondary Objectives:        -  To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® on:        -  Change in Fasting plasma glucose (FPG);        -  Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG          profile;        -  Percentage of patients reaching HbA1c targets <7% or ≤6.5%;        -  Percentage of patients reaching HbA1c targets <7% or ≤6.5% without severe and/or          confirmed hypoglycemia        -  Percentage of patients requiring rescue therapy.        -  To assess the frequency of occurrence and diurnal distribution of hypoglycemia by          American Diabetes Association (ADA) category of hypoglycemia.        -  To assess the safety in each treatment group.        -  To assess the treatment effects in each treatment group on Patient Reported Outcomes          (PRO).   "
41828|NCT02738138|"     The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults     with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1     co-infection.   "
41830|NCT02738112|"     Hyo-mandibular suspension has been previously studied as a treatment for obstructive sleep     apnea (OSA) and has shown to be highly effective.      This is a prospective, multi-center, registry during which 30 subjects with OSA will be     considered for hyo-mandubular suspension treatment. After obtaining informed consent and     meeting all inclusions and exclusion criteria, subjects will be treated using the Encore     System. Subject follow-up with the physician or nurse will occur at one (1) week, one (1)     month, three (3) months, and twelve (12) months.      This study will assess the effectiveness of hyoid suspension in reducing the apnea-hypopnea     index (AHI), and improving the Epworth Sleepiness Scale (ESS), snoring (VAS) and functional     outcome (FOSQ) for the treatment of obstructive sleep apnea (OSA). In addition, the study     will evaluate the effect that the change in hyoid position has on the airway anatomy.   "
41831|NCT02738099|"     Method: Single center, prospective, non-randomized, unblinded case series of all patients     presenting with a cardiac arrest. The proposed study will collect data on all comatose     patients presenting with cardiac arrest. The primary end point is death from any cause at 30     days from admission.      Significance: Develop criteria to guide an invasive strategy for comatose patients presenting     with cardiac arrest, and so avoid ineffective or even futile therapy which carry its own     significant risks for patients in the future. The criteria, in turn, can serve as the basis     for a prospective, randomized trial in the future.   "
41832|NCT02738086|"     This pilot study will use mobile-health technology to deliver an intervention designed for     lasting physical activity behavior change. The study will assess the feasibility of using the     Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation.     This intervention will be delivered using wrist-worn wearable activity sensors and a     home-based tablet computer to allow real-time physical activity feedback and video interface     between the participants and the therapist.   "
41833|NCT02738073|"     Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen     to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has     been shown effective in decreasing blood loss both intra-operatively and in the immediate     post-operative period in elective hip and knee arthroplasty patients. Both the timing and     dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has     also been shown to decrease as result of TA administration. Despite the support for TA     utilization that exists in the arthroplasty literature, the data is scarce regarding its     administration during surgical treatment of hip fractures. This is patient population who is     at high risk for transfusion due to symptomatic post-operative anemia. This study aims to     investigate whether TA's advantageous effects in the arthroplasty patient population can be     extrapolated to the more unstable, heterogeneous hip fracture patient population. If the     study is able to show a difference in blood loss and transfusion requirement, the long term     implications of this with regards to cost and mortality can be significant.   "
41834|NCT02738060|"     To investigate the effect of baked milk in immunotherapy of cow's milk allergy.   "
41836|NCT02738034|"     Systemic arterial hypertension is a disease with high prevalence in several countries,     including Brazil. Many studies have correlated hypertension with accelerated loss of     cognitive function, especially executive functions. There is some evidence that working     memory (WM) is compromised in these populations. However, some computerized training has been     developed to rehabilitate the WM, and among them the investigators highlight the Cogmed.     Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance     of WM and attention of hypertensive patients, as well as the impact of training in the     structure and brain function.   "
41837|NCT02738021|"     A Stepped Care pathway for managing postpartum depression (PPD) in pediatric primary care     settings will be used to (1) understand context for implementation feasibility (2) evaluate     benefits for mother and child.      The proposed pilot project will be conducted as part of a quality improvement effort in the     Department of Pediatrics at Gouverneur Health Services to improve management of postpartum     depression during pediatric primary care visits. This project will test the feasibility of a     stepped care approach to identifying and managing depression among mothers of infants (0-6     months). This study will provide preliminary data on the feasibility of the care management     protocol, implementation and fidelity measures, and training/consultation methods within a     real world pediatric care practice. These data will inform and support the preparation of a     large-scale NIH grant.      Specific research questions include:        1. To pilot the feasibility of using a Stepped Care Approach to identify and mange maternal          depression within primary care pediatric care visits, with a focus on mothers of infants          0-6 months.             1. Train non specialty MH providers to systematically identify maternal depression.             2. Assess how effective integration of maternal depression intervention is as part of               well baby visits.        2. To o examine the impact of STRONG, a brief 3-session IPT-based preventive intervention,          on maternal and child health outcomes (e.g., maternal depression symptoms, child receipt          of acute care services). Secondary outcomes include maternal social support and          parenting practices.   "
41838|NCT02738008|"     Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be     evaluated for safety and efficacy.   "
41839|NCT02737995|"     Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative     capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients,     but the relationship to exercise intolerance and mitochondrial oxidative capacity is unknown.     This is a pilot study to determine the feasibility of the use of specialized 31P-MRS and MRI     techniques for measurement of skeletal muscle bioenergetics in patients with heart failure     with and without functional iron deficiency.   "
41887|NCT02737345|"     1. Further characterize the incidence of hyperfibrinolysis in cirrhotics        2. Correlate hyperfibrinolysis with             1. hepatitis C             2. alcoholic liver disease             3. the subset of a&b with renal failure with and without dialysis        3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics   "
41888|NCT02737332|"     The purpose of this study is to evaluate the serum testosterone levels in patients with     Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as     Compared to Abiraterone Acetate   "
41840|NCT02737982|"     The application of sex-gender medicine is strongly recommended by World Health Organization     and other international organization. In fact, it is emerging that, although men and women     are affected to the same cardiovascular diseases (CVD), however they have different risk     factors, disease progression and response to pharmacological and not-pharmacological     treatments. Consequentially, the identification of biomarkers and therapeutic approaches     taking into account sex gender differences (SGD) is relevant to develop a really     evidence-based medicine.      With the aim of translate in clinical setting the more recently available basic research     evidences on estrogens and androgens balance involvement in modulation of     ischemia-reperfusion myocardial damage, the investigators planned to conduct a research study     on patients, affected by suspected or known ischemic heart disease (IHD) undergoing     angiography and/or percutaneous coronary interventions (PCI), aged more than 18 years of both     sex in ratio 1:1. Thus, in this setting, the goals of this proposal are:        1. To assess the sex-gender difference in entity of microvascular reperfusion damage in          patients with IHD undergoing urgent or elective PCI;        2. To evaluate estrogen/androgen-dependent and -independent effects in gender-related          differences on myocardial ischemia reperfusion damage occurring during PCI;        3. To investigate the differences in terms of platelet biology between men and women          affected by IHD undergoing urgent or elective PCI, matched for age and clinical          cardiovascular and metabolic characteristics;        4. To verify sex-driven interplay between response to PCI procedure, platelet function, sex          hormones and entity of reperfusion and myocardial damage, as well as, the impact on          clinical outcomes during a 1-year follow up.      This research study wants to explore and consequently elucidate biological mechanisms     responsible for sex-based differences in vivo human models of ischemia reperfusion myocardial     damage. Moreover, the investigators expected to clarify the impact of biological variables     evaluated on clinical outcomes after reperfusion therapeutic intervention.   "
41841|NCT02737969|"     This is a pilot study of patients undergoing structural heart disease procedures that utilize     TEE and fluoroscopic guidance at the New York University (NYU) Langone Medical Center.     Patients in this study will undergo their procedure utilizing the TEE/Angio fusion software     prototype. This protocol is primarily intended to ascertain the potential utility of the     software prototype in the study population and to provide data and feedback to improve the     workflow and algorithms of the prototype. As such, a primary outcome variable and statistical     analysis plan have not been identified. However, procedural time, measures of radiation     exposure (dose area product, total radiation dose, fluoroscopy time), degree of residual     valvular regurgitation or paravalvular regurgitation as applicable, and complications will be     recorded.   "
41842|NCT02737956|"     This study is to build a Xinjiang people registry and surveillance system for acute     myocardial infarction(AMI) in2012-2015years to obtain real-world information about patient's     basic information, patient characteristics, diagnostic test mode, the program of treatment     and hospitalization outcomes including mortality, treatment complications, the cost of     hospitalization and follow-up terminal events (death, major adverse cardiac events, minor     adverse cardiovascular events)of xinjiang AMI patients; And to propose scientific precaution     strategies aimed to prevent effectively from the incidence of AMI; And to optimize the     management and outcomes of AMI patients through implementation of guideline recommendations     in clinical practice, and analysis and development of effective treatment strategies; And to     create cost-effective assessment system.   "
41879|NCT02737449|"     The primary objective is to prospectively study the comparative effectiveness and comparative     safety of approved therapies for RA in a Japanese cohort of patients treated by     rheumatologists. Specifically the effectiveness and safety of newer classes and dosages of     disease modifying anti-rheumatic drugs (DMARDs); e.g. higher dose methotrexate (MTX),     non-tumor necrosis factor (TNF) biologics, and Janus Kinase (JAK) inhibitors) will be     compared with anti-TNF biologics.   "
41843|NCT02737943|"     40 Egyptian Cases with split-thickness skin graft receiving treatment at Zagazig University     Hospitals. Study Duration:6 Months .Description of Agent or Moist Exposed Burn Ointment     (MEBO).      Intervention:      Objectives: Primary: to determine the efficacy of MEBO versus standard care in improving the     healing speed and re-epithelization process of skin graft donor and recipient sites.     Secondary to determine the efficacy of MEBO in decreasing recovery time, rate of infections,     rate of complications, total treatment costs and its effect on improving pain alleviation.      Description of Study Design: Arm 1 20 MEBO at sites of donor graft and recipient at time of     operation and in dressing Arm 2 20 Standard cream Zagazig University Hospital (Antibiotics &     analgesics) Estimated Time to Complete 5 months   "
41844|NCT02737930|"     The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake     inhibitor commonly used for depression, enhances visual recovery after an acute ischemic     stroke.   "
41845|NCT02737917|"     To determine the impact, if any the application of oxygen during the apnea period of rapid     sequence intubation has on patients being intubated in the emergency department.   "
41846|NCT02737904|"     This randomised controlled trial aims to explore the effectiveness of a four week programme     of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of     spasticity in people with moderate to severe Multiple Sclerosis.   "
41847|NCT02737891|"     Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2     Diabetes Mellitus   "
41848|NCT02737878|"     Dementia is one of the most pressing health care issues of the 21st century. Evidence     suggests that exercise enhances cognitive function in healthy older adults. Most research has     focused on aerobic training (AT). Therefore, investigators aim to assess the individual     effects of AT and resistance training (RT), as well as the interaction effect of combining     the two types of exercise training, on cognitive function in older adults with mild cognitive     impairment.   "
41849|NCT02737865|"     Focal nodular hyperplasia (FNH) in liver is the second common benign hepatic tumor. It     usually shows hypervascular mass on imaging studies and it is not easy to differentiate with     other hypervascular malignant tumor. For diagnosis of FNH, contrast-enhanced ultrasonography     (US) has been used to detect 'spoke-wheel sign', which can be typically seen in FNH. However,     temporal window of vascular phase using contrast-enhanced US (CEUS) is very short (about 10     sec) and coordination of patient`s respiration during US exam is absolutely needed. Thus, the     investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for detection of     'spoke-wheel sign' in patients with proven FNH, which enable to detect slow micro vascular     flow without using CEUS.      First, to compare the detection rate of 'spoke-wheel sign' between CEUS using sonazoid     (Perfluorobutane, GE healthcare) and SMI.      Second, to compare the accuracy of size measurement between gray-scale US and SMI (reference     standard: CEUS using sonazoid.)   "
41850|NCT02737852|"     To evaluate the safety of a new personal lubricant when used at least four times weekly for     two weeks (including at least twice weekly during sexual intercourse for subjects with     monogamous male partners), in a population consisting of healthy females.   "
41889|NCT02737319|"     The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention     of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.   "
41890|NCT02737306|"     This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to     evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD     prophylaxis treatment for prevention of acute GVHD in adult patients with AML or MDS     undergoing allogeneic stem-cell transplantation.   "
41851|NCT02737839|"     Chronic disease self-management is the ability of the individual, in conjunction with family,     community and healthcare professionals to manage symptoms, treatments, lifestyle changes and     psychosocial, cultural and spiritual consequences associated with a chronic condition.     Self-management strategies have been successfully used in supportive care and survivorship in     oncology. Stepping On, a multi-component program using a small-group learning environment,     reduces falls by 31%. It empowers participants with knowledge about fall-risk, exercise,     medications and environmental hazards to self-manage their risk of falls over 7 weeks of     educational sessions, followed by a home visit. The research in this proposal will yield the     adaptation of the effective group-education-based fall-prevention intervention Stepping On,     tailored to cancer patients, feasible for testing in a multi-institutional trial, and     ultimately scalable in the oncology setting.   "
41852|NCT02737826|"     Chronic opioid therapy for pain can be associated with significant risks, and a significant     number of patients maintained on chronic opioids have continued pain and/or poor functioning.     When patients need to or want to come off their opioid pain medications, there is little to     guide physicians as to how to best help them do so, and it is not known how patients do after     coming off opioid medications. The goals of this study are (1) to evaluate two medications in     assisting patients in coming off their opioid pain medications and (2) determining outcomes     after discontinuing opioids.   "
41853|NCT02737813|"     Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect     the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric     bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher     cardiac output than those who received phenylephrine   "
41854|NCT02737800|"     Investigators compare ICSI results for endometrioma patients with or without cyst aspiration     if more than 5cm &with or without GnRh agonists for all endometrioma patients   "
41855|NCT02737787|"     The purpose of this study is to test the safety of a combination of an investigational WT1     vaccine and another drug called nivolumab. This is the first time that the WT1 vaccine and     nivolumab are being used in combination.   "
41856|NCT02737774|"     This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety     of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR     mutation.   "
41857|NCT02737761|"     The purpose of the study is to understand how positive emotions (e.g., optimism, happiness)     are associated with health behavior adherence in patients with heart failure (HF), as well as     whether performing exercises to improve positive emotions may help to improve health behavior     adherence as well.   "
41858|NCT02737748|"     Primary objective:        1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)          for Phase I in terms of Incidence of treatment-related AEs and SAEs (including          infections and bleeding)        2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor          site wounds (DSW) in terms of The healing time from DSW creation to 100%          re-epithelialization      Secondary objective:        1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds          (DSW) in secondary efficacy endpoints        2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)          in secondary safety endpoints   "
41859|NCT02737735|"     To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor     treatment of Chinese Herbs based on syndrome differentiation   "
41860|NCT02737722|"     Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or     II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS     score of 0 to 3 and DFI wound score of 1 to 3.   "
41861|NCT02737709|"     By detecting the blood concentration of paclitaxel (PTX), Investigator assume this research     can identify the individual differences of PTX pharmacokinetics (PK) parameters (TC>0.05     refers to the duration of paclitaxel plasma concentration above 0.05 µmol/L) in Chinese     non-small cell lung cancer (NSCLC) patients, and find the correlation between PK results and     PTX toxicities and Effectiveness, acquire the optimization method of PTX, and finally try to     explore the individualized PTX pharmacokinetically-guided dosing strategy. Orally administer     rosiglitazone, which is a substrate of CYP2C8 the same as paclitaxel, before chemotherapy     injection. Detect the blood concentration of rosiglitazone, analyze the correlation of     rosiglitazone pharmacokinetic parameter and paclitaxel exposure, and explore the effect of     rosiglitazone as an in vivo probe of paclitaxel exposure.        1. The variability of paclitaxel concentrations in the patient population dosed by body          surface area (BSA), and the limitation of BSA-based dosing of paclitaxel.        2. Verify that paclitaxel TC>0.05 is the most relevant predictor of haematological toxicity          and clinical outcomes.        3. Define a dosing algorithm based on paclitaxel TC>0.05 of paclitaxel and quantify its          effect on both reducing toxicity and improving Effectiveness.        4. The effect of using dose modification and administration of G-CSF based on toxicity          determined by paclitaxel TC>0.05 measurement.        5. Construct a trial outline with the aim of reducing grade 4 neutropenia toxicity and          ensuring the clinical outcome by using individual dose adjustments based on the dosing          algorithm.        6. Detect the blood concentration of rosiglitazone after orally administration, explore the          effect of rosiglitazone as an in vivo probe of paclitaxel exposure based on CYP2C8          activity. Attempt to establish a model to predict the paclitaxel exposure of patients          base on rosiglitazone blood concentration before chemotherapy.   "
41862|NCT02737696|"     The investigators are developing an interactive, web-based program for youth ages 12-17     focused on the prevention of prescription opioid abuse because to the investigators     knowledge, no science-based, interactive program focused on the prevention of prescription     opioid abuse among youth exists. This program is grounded in a scientific understanding of     risk factors for prescription opioid abuse among youth, employs informational technologies     which are effective in promoting relevant knowledge and skills, and presents program content     using strategies shown to be highly appealing to adolescents. In the completed Phase 1 of     this project, the investigators developed and demonstrated the scientific, technical and     commercial merit and feasibility of a prototype of a web-based, prescription opioid abuse     prevention program for youth. In Phase 2, the investigators will complete the development of     all components of the multimedia, prescription opioid abuse prevention program and conduct a     randomized, controlled trial with youth to evaluate the effectiveness of the web-based     prevention intervention in increasing knowledge about key issues relevant to prescription     opioid abuse among youth, skills acquisition relevant to preventing their misuse, negative     attitudes about prescription opioid misuse, and perceived risk associated with their misuse.     The investigators will also assess the program's effectiveness in reducing intentions to     misuse prescription opioids as well as actual rates of such use. If this tool is shown to be     effective, the investigators plan to embed it in a suite of science-based,     technology-delivered tools focused on the prevention and treatment of substance use disorders     that have been developed and deployed in a wide array of settings by the investigative team.   "
41863|NCT02737683|"     Patients with indigestion were often found in gastroenterology clinic, those who about 20 %     was caused by organic, while the rest of patients are showed abnormal inspection, and these     are so called functional dyspepsia. Functional dyspepsia is a chronic and repeated occurrence     of digestive disorders, patients often visit hospitals frequently and unable to get fully     cured. Current Symptom diagnoses are based on Rome III criteria as diagnostic criteria.     Although functional dyspepsia condition should combine with physical and mental treatments,     due to the reasons behind the complex, there is still no effective classification could be     acted in health education and drug intervention.   "
41864|NCT02737670|"     The objective of this prospective randomized and double blind controlled study is to evaluate     the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic idiopathic     subjective tinnitus.   "
41865|NCT02737657|"     The primary purpose of this study is to describe the tolerability of canagliflozin and any     sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms     of the percentage of patients with at least one episode of hypoglycaemia, in patients with     T2DM who fast during Ramadan.   "
41866|NCT02737644|"     The study is a nested case-control study and the purpose is to describe the status of key     nutrients(eg.folic acid and vitamins) supplementation among pregnant women in Shanghai, to     find out the association between the level of serum key nutrients during peri-conceptional     period and the incidence of congenital heart defects (CHD) in newborn, and to provide better     preconception care.   "
41867|NCT02737605|"     The purpose of the study is to assess the effects of esketamine on QT/QTc intervals and     electrocardiogram (ECG) morphology at therapeutic exposures of esketamine and noresketamine     (intranasal administration) and supratherapeutic exposures of esketamine (intravenous     administration) in healthy adults.   "
41868|NCT02737592|"     To evaluate the safety of a personal lubricant when used at least four times weekly for two     weeks (including at least twice weekly during sexual intercourse for subjects with monogamous     male partners), in a population consisting of healthy females.   "
41869|NCT02737579|"     This study will evaluate the use of x-ray fused with MR images as an imaging tool to help     guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.   "
41904|NCT02737124|"     Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will     take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be     given a similarly looking placebo pill. A multitude of post-op variables will be included,     mainly pain scores and morphine equivalent doses at different time points.   "
41870|NCT02737566|"     The primary objectives of this study are 1) to evaluate the longer-term impact of an     adjunctive, low-cost financial incentives intervention (relative to standard care) on smoking     abstinence rates among socioeconomically disadvantaged individuals participating in a     clinic-based smoking cessation program and 2) to identify treatment mechanisms and contextual     factors associated with cessation outcomes among intervention participants using both     traditional and ecological momentary assessment approaches. Those randomized to the financial     incentives intervention will have the opportunity to earn small gift cards for     biochemically-verified abstinence through 12 weeks post-quit. We hypothesize that individuals     who are randomly assigned to the adjunctive CM intervention will have significantly higher     rates of biochemically-verified abstinence at the 26-week post-quit follow-up than those     assigned to Usual Care. In addition, we hypothesize that several factors related to     socioeconomic disadvantage will be directly associated with non-abstinence, especially     greater stress/adversity, limited psychosocial resources, greater negative affect, greater     nicotine dependence, and poorer treatment adherence. The primary study endpoints will include     self-reported tobacco use/abstinence, expired carbon monoxide (CO) levels (i.e., the amount     of carbon monoxide present in an individual's breath when they breathe out), and saliva     cotinine levels at 26 weeks post-quit attempt, though smoking status will be assessed at all     visits. Traditional questionnaire measurement and ecological momentary assessment (EMA) will     be utilized to measure potential treatment mechanisms including motivation, self-efficacy,     and treatment adherence. Other variables including stress/adversity, psychosocial resources,     negative affect, nicotine dependence, and treatment adherence will also be assessed.   "
41871|NCT02737553|"     Laparoscopic tissue removal is one of the most challenging parts for the laparoscopic     surgery. For this reason, electromechanical morcellation has long been used to facilitate the     tissue removal in gynecology. However, electromechanical morcellation has long been performed     inside the abdomen without any containment. Therefore, this practice has recently undergone     increased scrutiny because of important concerns related to tissue dissemination during     intracorporeal power morcellation. Thus, the US Food and Drug Administration released a     safety communication discouraging power morcellation in laparoscopic hysterectomy and     myomectomy procedures in April 2014.      As a result of this serious concern, the enclosed laparoscopic power morcellation has been     come into prominence in gynecological surgery. Besides the removal of the tissues through     vagina with posterior colpotomy is considered an another solution for this critical problem.      In the literature the comparison for the two techniques for tissue removal is considerably     scarce. Therefore researchers are aiming to prepare a trial to compare the laparoscopic     enclosed electromechanical morcellation and tissue removal thorough vagina with posterior     colpotomy according to surgical time, postoperative pain and postoperative sexual function.   "
41872|NCT02737540|"     The main objective of this study is to confirm the existence of risky decision making in a     non strategic situation (Iowa Gambling Task) and a deficit of decision making in social     situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of     trust (Trust Game) in elderly depressed patients with a history of suicide attempts in     comparison with older depressed patients without a history of suicidal acts and healthy     subjects.   "
41873|NCT02737527|"     This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar     sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in     shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and     safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates to     fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to sympathetically     maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the     informed consent will be enrolled.   "
41874|NCT02737514|"     Interval (missed) cancers and lower than expected mortality reduction of proximal colon     cancers in the United States and elsewhere after screening colonoscopy drew attention to     quality indicators. Missed adenomas which are more likely to be in the proximal colon may be     contributing factors. An independent predictor of the risk of interval cancers is adenoma     detection rate. In pilot observations, the investigators showed that water exchange enhanced     adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized     controlled trial will compare water exchange with water immersion and traditional air     insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that     compared with air insufflation and water immersion, water exchange produces a significantly     higher adenoma detection rate in the right colon   "
41875|NCT02737501|"     A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in     ALK-positive Advanced Lung Cancer Patients   "
41876|NCT02737488|"     The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy     (TST) decreases children's mental health symptoms (such as acting out, not controlling their     emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events can     include experiencing or witnessing violence, excessive bullying, war, car accident, serious     injury, getting mistreated or anything else that makes one feel scared or frightened.     Children/teens who experience traumatic events have been shown to be at higher risk of poor     mental and physical health. Trauma can impact family life, school life and interpersonal     relationships well into adulthood. Unfortunately, most children who have experienced     traumatic events do not undergo treatment. Although promising treatments do exist, most do     not address the complexity of trauma, particularly related to ongoing stress and threats to     safety in their environments. One hundred and twenty eligible youth will be randomized to     receive either treatment with TST at NYU's Child Study Center or trauma treatment as usual     (TAU) at a community mental health clinic.      It is hypothesized that:        -  Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress          Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to          youth receiving treatment as usual (TAU) in the community.        -  Youth receiving TST will demonstrate a greater decrease in symptoms of depression,          anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.)          at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU.        -  Youth receiving TST will have fewer acute mental health service events, such as          psychiatric hospitalizations and ED visits compared to youth receiving TAU.        -  Greater fidelity to the TST model is associated with better treatment outcomes among          youth receiving TST.   "
41877|NCT02737475|"     The purpose of the study is to determine the safety and tumor-shrinking ability of     experimental medication BMS-986178, when given by itself or in combination with Nivolumab     and/or Ipilimumab, in patients with solid cancers that are advanced or have spread.   "
41878|NCT02737462|"     <Part I - Phase I trial> The phase I clinical trial is to identify the MTD (Maximum Tolerated     Dose) and DLT (Dose Limiting Toxicity) of CG200745 PPA. Initial dose of CG200745 PPA is 150     mg/m^2, and it will be extended to 225 mg/m^2, 300 mg/m^2 or it will be reduced to 75 mg/m^2     based on the results of the cohort of 3 subjects per dose level.      Based on the 3+3 dose escalation study design, CG200745 PPA is to be administered as in four     different cohorts according to the dose level. Each cohort consists of 3 or 6 subjects.      <Part II - Phase II trial> In the phase II clinical trial, the subjects will be administered     with the dose which is to be identified as a recommended dose based on the results of Phase I     study. The whole one cycle is consisted of 28 days, same as the phase I. The entire treatment     period is 6 cycles and tumor assessment is evaluated every 2 cycles.   "
41880|NCT02737436|"     The investigators plan to conduct functional MRI scanning with a group of mothers who are     blindly and randomly assigned either intranasal oxytocin or a placebo. The purpose of this     investigation is to explore how oxytocin may modify early maternal brain and behavioral     responses to infant cues. This study will examine, for the first time, a potential     pharmacological intervention for maternal neglect which targets core neurobiological     deficits. This may eventually be used to supplement and augment other psychosocial and     behavioral interventions.      In addition, the investigators will examine sex differences in parental brain and behavioral     responses to oxytocin by also recruiting the male partner of enrolled mothers to participate     in a similar protocol.   "
41881|NCT02737423|"     The main objective of the study is to assess the effect of vitamin D treatment on painful     diabetic neuropathy in Pakistan.      This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single     dose of 600,000 IU of Vitamin D.      All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to     participate in the study. The change in painful diabetic neuropathy scores was assessed using     DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at each     visit.   "
41882|NCT02737410|"     Background:      Resilience refers to a class of variables highly relevant for wellbeing and coping with     stress, trauma, and chronic adversity. Despite its significance for health, resilience is     hardly examined empirically and suffers from poor conceptual integration. Irritable bowel     syndrome (IBS) is a functional disorder with altered psychological stress reactivity and     brain-gut-microbiota axis, which causes high chronic strain. Gut-focused hypnotherapy (GHT)     is a standardized treatment for IBS targeting at resilience. An increase of resilience by GHT     has been hypothesized but requires further investigation.      Aims of the study were construct validation and development of an integrational measure of     different resilience domains by dimensional reduction, and investigation of change in     resilience in IBS patients by GHT.      N=74 Gastroenterology outpatients with Irritable Bowel Syndrome (Rome III criteria) were     examined in 7 resilience domains, quality of life, psychological distress and symptom     severity. n=53 of these participate in 7 to 10 Gut-directed Hypnotherapy group sessions     (Manchester protocol). Post-treatment examinations were performed 10 months after last GHT     session.   "
41883|NCT02737397|"     The purpose of this study is to determine the safety and efficacy of a combination product     for the prevention of veisalgia. Common symptoms of veisalgia following the moderate     consumption of alcohol includes headache, fatigue, and thirst. It is the investigators     hypothesis that a combination of two drugs can alleviate or significantly reduce these     symptoms when taken before the start of moderate alcohol consumption.   "
41884|NCT02737384|"     The purpose of this study is to evaluate selective depletion of naïve CD45RA+ T cells from     allogenic peripheral blood stem cell graft in children transplanted for combined immune     deficiency. The aims of this procedure are to prevent graft versus host disease (GVHD) while     preserving anti-infectious response from donor memory T lymphocytes.   "
41885|NCT02737371|"     Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study.     Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group     consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each     subject will be dosed for 10 days and will be on study for approximately 7 weeks. Each     subject will participate in one treatment cohort only, residing at the Clinical Research Unit     (CRU) from Day -1 (the day before dosing) to Day 15 (120 hours post the last dose). The dose     will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses     divided over the 24-hour dosing period.      All subjects will return for a post-study visit 8 to 10 days after the last dose of study     medication.      Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety     and pharmacokinetic data of each cohort prior to each dose escalation.   "
41891|NCT02737293|"     This project will evaluate the daily intake of whole eggs in the Mediterranean Diet (Med     Diet). Cholesterol levels are normally related to cardiovascular disease (CVD) risk. Dietary     fat and the total diet makeup are well known modifiers of CVD risk. The Med Diet has been     shown to decrease blood lipids (fats) and reduce inflammation. Cholesterol intake from eggs     may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat)     levels. This study is being done to test how the addition of eggs to a Med Diet affects blood     lipids and other risk markers for CVD.   "
41892|NCT02737280|"     Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen     saturation is low. In earlier observational clinical studies, the use of high flow nasal     cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of     intubation and intensive care. This study is a randomized controlled trial in two pediatric     university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen     therapy in infants with bronchiolitis.   "
41893|NCT02737267|"     This study evaluates the relationship between several genetic variants and the response to a     hypocaloric diet, in order to design a genetic test which permits prescribe the more     personalized diet for each individual according to her genotype. Half of the participants     will assigned to a moderate high protein diet, while the other half will assigned to a high     carbohydrate diet.   "
41894|NCT02737254|"     The purpose of this study is to investigate the effects of oxytocin and a cognitive bias     modification (CBM) procedure on children's trust in their mother.   "
41895|NCT02737241|"     HoLEP (Holmium laser enucleation of the prostate) entails dissection of the whole median and     lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the     apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate     bed then intravesical morcellation of the enucleated adenoma.      The investigators are going to compare safety and efficacy of low power; LP-HoLEP vs. high     power; HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH (Benign prostate     Hyperplasia).   "
42028|NCT02735512|"     This pilot research trial studies how well myeloid derived suppressor cells (MDSC) clinical     assay works in finding and monitoring cancer cells in blood and urine samples from patients     with or without localized or metastatic bladder cancer. Studying samples of blood and urine     from patients with or without bladder cancer in the laboratory may help doctors identify and     learn more about biomarkers related to cancer and may help doctors improve ways to diagnose     and treat patients.   "
42029|NCT02735499|"     Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder   "
41896|NCT02737228|"     <Part I - Phase I trial>      The phase I clinical trial is to identify the MTD (Maximum Tolerated Dose) and DLT (Dose     Limiting Toxicity) of CG200745 PPA in combination use of Gemcitabine and Erlotinib. Initial     dose of CG200745 PPA is 187.5 mg/m^2, and it will be extended to 250 mg/m^2, 312.5 mg/m^2 or     it will be reduced to 125 mg/m^2 based on the results of the cohort of 3 subjects per dose     level.      Based on the 3+3 dose escalation study design, Gemcitabine and Erlotinib are administered as     fixed doses, whereas CG200745 PPA is to be administered as in four different cohorts     according to the dose level. Each cohort consists of 3 or 6 subjects.      <Part II - Phase II trial>      In the phase II clinical trial, the subjects will be administered with the dose which is to     be identified as a recommended dose based on the results of Phase I study. The whole one     cycle is consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles     and tumor assessment is evaluated every 2 cycles.   "
41897|NCT02737215|"     Background. Atrial fibrillation is one of the most common complications in the postoperative     period of coronary artery bypass grafting (CABG) surgery and usually associated with     increased length of hospital stay and higher hospital costs. Among the main mechanisms     involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental     elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the     effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation     after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter     randomized controlled study to compare the incidence of atrial fibrillation between the     intervention group and the control group, both monitored seven days with Holter.   "
41898|NCT02737202|"     This study is being done to determine if there is a potential benefit of saracatinib in LAM     subjects. Based on the information of this trial, additional clinical development trials will     be needed. The study will also test the tolerability of 125 mg of saracatinib given once     daily over a 9 month period.   "
41899|NCT02737189|"     Endovascular treatment of acute ischemic stroke has shown strong benefit in several     prospective randomized trials in the anterior circulation and endovascular therapy for     basilar artery occlusion has shown promising results in several single-arm studies. This has     led to a broad adoption of these techniques which are now considered standard of care in many     institutions despite the lack of adequate evidence to prove their benefit. Indeed, the rates     of symptomatic intracerebral hemorrhage in these studies have consistently been around 5%     which raises the question as to whether patients could actually be harmed as opposed to     helped by these procedures. This is a prospective, multi-center, randomized, controlled,     open, blinded-endpoint trial, with the aim to evaluate the hypothesis that mechanical     embolectomy with the Solitaire device is superior to medical management alone in achieving     better outcomes in subjects presenting with an acute ischemic stroke caused by occlusion of     the basilar artery within 6-24 hours from symptom onset.   "
41900|NCT02737176|"     This study is to verify the efficacy of tobacco cessation in patients with oral diseases;     periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.     Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation     intervention for the subjects, attending doctors implement standard treatments for their oral     diseases. Improvement of each disease is evaluated between smoking cessation intervention     group and non-cessation intervention group.   "
41916|NCT02736968|"     This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment     study to compare placebo to once daily doses of 6mg auranofin for adults with asymptomatic     amebiasis or giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm)     and 68 with giardiasis (34 per arm); Power based on 60 subjects with amebiasis and 60 with     giardiasis completing the study. Primary objectives are 1) to compare the proportion of     subjects with parasitological response (no detection of cysts or trophozoites of E.     histolytica on microscopic exam or negative antigen detection) by Day 7 for E. histolytica     infections and 2)to compare the proportion of subjects with parasitological response (no     detection of cysts or trophozoites of G. lamblia on microscopic exam or negative antigen     detection) by Day 5 for Giardia infections. The length of this study is set for 3.5 years;     subject participation is 7 days treatment (amebiasis) and 5 days (giardiasis) with follow-up     until day 28   "
41901|NCT02737163|"     The treatment of hydrocephalus is the most time consuming, and arguably the most important     role of the pediatric neurosurgical service at most children's' hospitals. Despite many     technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay     of hydrocephalus treatment. While often lifesaving, CSF shunting procedures are associated     with high complication rates and account for a disproportionate share of health care     expenditures and morbidity.      Programmable CSF shunt valves, through which CSF flow and pressure can be adjusted by quick     and painless transcutaneous reprogramming, have been implanted for more than 15 years in the     developed world. Reprogramming these valves relies on rotational magnetic forces, which are     applied by neurosurgeons and neurosurgical advanced practice providers. Inadvertent     reprogramming (IR) can occur when patients with these valves are exposed to magnetic fields     in the environment, which may lead to serious symptoms that may require urgent reprogramming     and/or surgery.      The concurrent proliferation of magnetically sensitive programmable CSF shunt valves and     household items that generate substantial magnetic fields has caused concern among patients,     parents and providers about the potential consequences of inadvertent valve reprogramming.     This growing concern led the FDA to issue a warning to individuals with programmable valves     in 2014, which deemed the programmable valves safe for use but vulnerable to IR when     household devices such as tablets or cell phones are placed within 2 inches of the valve. The     FDA recommended further study, stating that no systematic evaluation had been performed     regarding the prevalence of accidental valve adjustments.      By evaluating each of the patients with magnetically susceptible CSF shunt valves, during     each of the routine points of contact with the service, investigators aim to define the     prevalence of inadvertent shunt reprogramming, to correlate with the presence and absence of     symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt     reprogramming based on exposure to common environmental items.   "
41902|NCT02737150|"     Aim of the study is to demonstrate equivalence of second-generation self-expandable valves     (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards     Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia     with respect to safety and efficacy in high-risk patients with severe aortic stenosis     undergoing transcatheter aortic valve implantation.   "
41903|NCT02737137|"     In clinical practice, local anesthetic injection pressure monitoring is performed manually or     by a pressure transducer according to the availability of the equipment or preferences of     clinicians. To date, no comparative study has measured the advantages of this measure during     PNB.      The aim of this study is to evaluate injection pressure monitoring in order to reduce the     risk of intraneural injection during peripheral nerve blocks   "
42030|NCT02735486|"     The primary aim of the study was to investigate the acute effect of ginger drink consumption     on the risk markers of cardiovascular disease.   "
41905|NCT02737111|"     This study aims to further understand the experiences of children, their parents and siblings     around the time when the child and their family are informed of a diagnosis of an inherited     cardiac condition (ICC). The researchers are interested to understand how families experience     the process of receiving a diagnosis of an ICC, and explore experiences from multiple     perspectives within the family (i.e. parents, children and siblings).      The Primary Project Objective:      How do children, their parents and siblings experience the communication of a diagnosis of an     inherited cardiac condition (ICC)? What is found to be helpful and less helpful?      The Secondary Project Objective:      To explore qualitatively how families experience the communication of a positive diagnosis     for an inherited cardiac condition for a child and will seek the perspectives of the child     with the diagnosis, their siblings and parents.   "
41906|NCT02737098|"     The Veterans Health Administration (VHA) provides care to 3.3 million Veterans living in     rural areas, comprising 36% of all VHA enrollees. In 1995, VHA began expanding its system of     Community Based Outpatient Clinics (CBOCs) in order to improve access for the geographically     dispersed Veteran population. There are now approximately 900 CBOCs delivering a range of     services to approximately 64% of VHA enrollees. While these CBOCs have dramatically improved     access to first class primary care services, it has been more challenging to deliver     specialty mental health care to rural Veterans. Evidence based specialty mental care     practices developed for large VA Medical Centers are often not feasible to deploy in small     CBOCs and thus not accessible to rural Veterans. Rural Veterans with posttraumatic stress     disorder (PTSD) treated at CBOCs experience little to no improvement in their symptoms over     time. A major contributor of poor PTSD outcomes is that trauma-focused evidence-based     psychotherapy is not being provided to Veterans in the CBOC setting. Moreover, travel     barriers prevent most rural Veterans from receiving trauma-focused evidence-based     psychotherapy at large VHA Medical Centers (VAMC). Telemedicine Outreach for PTSD (TOP) is a     technology-facilitated virtual care clinical intervention that is designed to enhance access     to evidence based psychotherapy and pharmacotherapy. The VHA Office of Rural Health and     Office of Connected Health and Telehealth Services intend to deploy the TOP intervention     nationally. This project will lay the ground work for this national implementation     initiative.      The goal of this implementation project is to support the national deployment of the TOP     intervention and evaluate its clinical effectiveness in routine care. The specific aims are     to compare the cost and effectiveness of alternative implementation strategies to promote     uptake of TOP and assess impact on access and PTSD outcomes.      The project will be conducted at 6 VAMCs and affiliated CBOCs without on-site psychologists     trained in trauma-focused evidence-based psychotherapy. The total anticipated sample size     will be 600.      The TOP clinical intervention is delivered by a virtual care team comprising a CBOC provider,     and a telephone care manager, telepsychologist and telepsychiatrist located at the VAMC. The     telephone care managers will coordinates care. The telepsychologists will deliver of     trauma-focused evidence-based therapy. The telepsychiatrists will provide psychiatric     consultation. The standard VA implementation strategy will follow standard procedures for     deploy clinical practices in the VA include disseminating support materials, providing     technical assistance and transfer funds to hire clinical personnel. The enhanced     implementation strategy will add external facilitation to the standard VA implementation     strategies. External facilitation will begin with an assessment of the current workflow at     the VHA Medical Center and the affiliated CBOCs. The external facilitation team will then     generate a clinical workflow chart that describes the current process of care. With advice     from the external facilitation team, local staff will then incorporate the clinical process     of the TOP intervention into the current clinical workflow chart.      The project will compare the standard VA implementation strategy to the enhanced     implementation strategy. All VAMCs will receive the enhanced implementation strategy if they     need it, but the time period during which they will receive the enhanced implementation     strategy will be randomized. This will allow us to determine whether more patients are     reached by the TOP intervention during standard implementation compared to enhanced     implementation. This design will also allow us to document improvements in perceived access     and PTSD outcomes for patients at sites that successfully implement the TOP intervention.     Data will be collected from patient survey and chart review for all patients sampled for the     evaluation. Participating patients will complete a baseline survey and 3 follow-up surveys.     The reach implementation outcome measure will be specified as the proportion of sampled     patients who received the TOP intervention. PTSD outcomes will be specified as a continuous     change in patient self-reported symptom severity between baseline and follow-up. Perceived     access will be measured using items specifically developed for the project. Provider adoption     will be assessed with qualitative interviews of all CBOC clinicians treating a sampled     patient as well as members of the TOP intervention team. Costs - The investigators will     measure the cost of both implementation strategies both prospectively and retrospectively.     The investigators will collect data on implementation activities during both the standard VA     and enhanced implementation strategies.   "
41907|NCT02737085|"     The main purpose of this study is to explore the sequential therapeutic effect of     CD19-targeted and CD20-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of     Diffuse Large B Cell Lymphoma(DLBCL)   "
41908|NCT02737072|"     The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C     Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in     participants with advanced refractory solid tumors.   "
41909|NCT02737059|"     This research study was being done to study the effect of codeine and Naloxegol for 3 days     compared to placebo on the movement of food through the colon of healthy individuals. Codeine     is a commonly used pain-relieving drug that often causes constipation as an unwanted side     effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation     induced by Codeine.      The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and     colonic transit induced by codeine in healthy participants.   "
41910|NCT02737046|"     The investigators propose to use Belinostat in combination with AZT as consolidation therapy     for the treatment of ATLL.   "
41911|NCT02737033|"     This study evaluates the use of Rhodiola rosea in the attention of adults with Attention     Deficit/Hyperactivity Disorder (ADHD). Half of participants will receive Rhodiola rosea     800mg, while the other half will receive 800mg of placebo.   "
41912|NCT02737020|"     This study evaluates the use of Rhodiola rosea in the treatment of Attention     Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola     rosea, while the other half will receive placebo.   "
41913|NCT02737007|"     This is an open-label, single-centre, non-randomized study to investigate the     pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy     male subjects.      Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The     study will provide an early readout on human pharmacokinetic parameters. The results of this     study will be used to estimate the potential duration of anti-parasite effect in humans,     define predicted clinical oral doses, and hence inform about the compound's potential safety     margin.      Each subject will participate in the study for up to 8 weeks, and will have a screening     visit, one treatment period, eight outpatient visits, and a follow-up visit.   "
41914|NCT02736994|"     The aim of this study is to evaluate the effect of PIP toothbrush cleaner® on the microbial     composition and Candida albicans colonization of denture biofilm formation. Additionally, its     effect will be compared to that of cleansing tablets.   "
41915|NCT02736981|"     This is a 3-arm randomized controlled trial to test the efficacy of three novel motivational     approaches to weight loss with 18-25 year olds. Participants will be 18-25 year olds with a     BMI of 25-45 kg/m2, randomized to: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous     Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a     6-month behavioral weight loss intervention, followed by a 6-month no-treatment follow up     period.   "
41917|NCT02736955|"     This Phase 3b, rollover study will provide subjects who completed a Phase 3 valbenazine     (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for     the treatment of TD until valbenazine is anticipated to be available commercially or they     complete 72 weeks of treatment. This study will allow enrollment of up to 75 medically stable     male and female subjects with TD who previously participated in and completed the     NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.   "
41918|NCT02736942|"     Background Surgery for mid and low rectal cancer is associated with relative high rates of     incomplete mesorectal excisions and high rates of circumferential resection margin (CRM)     involvement resulting in significant number of local recurrences. Moreover, patients with mid     and low rectal cancer suffer from high rates of morbidity, permanent colostomies and     impairment of quality of life. The transanal TME (TaTME) has been developed to improve the     quality TME in mid and low rectal cancer.      Study design The COLOR III trial is an international multicentre randomised study comparing     short- and long-term outcomes of TaTME and laparoscopic TME for rectal cancer. The study will     include a quality assessment phase before randomisation to ensure required competency level     and uniformity of the new TaTME technique and the laparoscopic TME. During the trial clinical     data will be reviewed centrally to ensure uniform quality.      Endpoints Primary endpoint is involvement of CRM. Secondary endpoints include morbidity and     mortality, residual mesorectum (postoperative MRI), local recurrence, disease-free and     overall survival, percentage of sphincter saving procedures, functional outcome and quality     of life.      Statistics In laparoscopic TME the percentage of involved CRM is estimated 7%. To detect a     reduction to 3% with a two-sided level of significance of 5% and a power of 80% a total of     1098 patients is needed. Randomisation will be in a 2:1 ratio in favour of the TaTME     procedure. It will be stratified for T-stage, preoperative radiotherapy, height of the     tumour, gender and BMI. All analyses will be on intention-to-treat basis.      Main selection criteria Patients with a histologically proved single mid or low rectum     carcinoma (0-10cm from anal verge) on MRI, eligible for TME surgery with a curative intent,     are included. Main exclusion criteria are T4 tumours, T3 tumours with a suspected involved     mesorectal fascia (MRF) after neoadjuvant therapy, patients with concomitant metastases or     other malignancies, with malignancies in their medical history or with signs of acute     mechanical obstruction by the tumour.      Hypothesis The hypothesis is that TaTME will result in a better mesorectum specimen quality     with a lower rate of involved CRM and therefore lower rate of local recurrence. Furthermore,     the TaTME procedure will potentially enable more sphincter saving procedures and will have     positive effect on functional outcome and health related quality of life.   "
41919|NCT02736929|"     Some individuals who are exposed to traumatic events experience both psychological and     cardiovascular changes that affect their health and well-being. The purpose of this study is     to learn more about how reducing the psychological symptoms (such as those that occur with     posttraumatic stress disorder, or PTSD) affects cardiovascular systems that regulate heart     and blood pressure.   "
42031|NCT02735473|"     This is a randomized, double-blind, placebo-controlled trial of choline supplementation in     children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are     cognitive measures.   "
41920|NCT02736916|"     Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with     limited stage small cell lung cancer (LD-SCLC). However, PCI is also associated with several     side effects, such as decline in memory and other cognitive functions. This provides the     rationale to explore the clinical feasibility of hippocampal avoidance during WBRT. Previous     studies have demonstrated the dosimetric capabilities of IMRT to conformally avoid the     hippocampus without detriment to the radiation dose the remaining brain receives. The aims of     this study is to evaluate the therapy efficacy and the safety profile of hippocampal-sparing     whole-brain radiation therapy (HS-WBRT) for PCI in patients with LD-SCLC.   "
41921|NCT02736903|"     Despite the racial disparities in rates of chronic diseases and behaviors linked to chronic     diseases, there have been relatively few RCTs of interventions to increase physical activity     in African American women. Although some studies found significant improvement on physical     activity, most focused on individuals and did not take into consideration the social contexts     in which the participants' behaviors occurred. Understanding how online social networks     facilitate behavior change can bridge important gaps in the way technology can be used to     intervene on health among underserved populations. The primary objective of this study was to     test the efficacy of a mobile app (PennFit) intervention in increasing participants' daily     active minutes objectively recorded by a fitness tracking device (Fitbit zip). In the control     group, participants used the PennFit app to record and monitor their own physical activity     progress. In the online social network intervention, participants were randomized to 4-women     networks and were able to see and compare their own recorded physical activities with     activities of the other three women in their network. Participants in a network had access to     an online chatting tool to chat with one another. The secondary objective was to understand     the intervention's mechanisms through mediation analysis on theoretical variables.   "
41922|NCT02736890|"     Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI).     Current existing treatment including both pharmacologic and non-pharmacologic are limited by     marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the     potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal     cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A     has been shown in both pre-clinical and clinical studies to help with nerve pain. The     researchers propose a double blinded placebo controlled crossover study to study the effects     of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord     injury.   "
41923|NCT02736877|"     The investigators will evaluate 30 patients with surgical indication for corneal     transplantation. Participants will be divided according to the following diseases diseases:     keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about     the risks and benefits of the study and sign an informed consent form. In the preoperative     evaluation will be submitted to a complete ophthalmologic examination with complementary     tests, such as optical coherence tomography.      One group of participants will undergo corneal surgery using the OCT Lumera microscope RESCAN     - ZEISS and another group with a conventional microscope. Everyone will have their filmed and     documented surgery. The team of surgeons will answer the questionnaire on the surgical     difficulty about the ease of assessing corneal transplantation. After surgery, participants     will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.      Surgeries and study procedures will be performed by the same team of surgeons and performed     by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.   "
41924|NCT02736864|"     The study assesses patients with cured pulmonary tuberculosis by compulsory notification data     of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients     will be invited by telephonic contact. After eligibility and exclusion criteria evaluation,     those included will be assessed in order to know structural and functional repercussions of     pulmonary tuberculosis sequelae.   "
41966|NCT02736318|"     Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile     osteochondral graft. To avoid having to harvest autograft material from the knee, a processed     allogeneic osteochondral can be used instead autograft. The surgical technique is to implant     in the osteochondral defect one to three products in the defect.   "
41925|NCT02736851|"     The aim of the study is to investigate if a home-based structured physician-directed,     nurse-managed telemedicine program can increase adherence to a home exercise program and     decrease neck pain and disability.      The study is carried out in 100 consecutive patients with chronic non-specific neck pain.      All patients referred to a rehabilitation Institute for an out-.patient visit complete a     stretching exercise program and are instructed and encouraged to perform exercises regularly     once at home. At the end of the rehabilitation, the patients are randomized into two groups     of 50 patients each. Patients of the first Group are allocated to a home-based telemedicine     (HBT), while those of the second group receive only the recommendation to continue exercising     at home (Control group). The HBT intervention consists of fortnightly scheduled phone calls     to patients over the 6-month course of the study. A nurse-tutor encourages the patient to     perform regularly physical activity and prescribes exercises.      Adherence to home exercises is evaluated 15 days and 6 months after the end of the outpatient     rehabilitation, while pain intensity and neck disability are assessed and compared in the two     groups at entry and 6 months after the end of the outpatient rehabilitation .   "
41942|NCT02736630|"     Primary objective of the study is to project the incidence rate of perioperative hypothermia     under general anesthesia in patients who go under minimum 1 hour long elective surgery in at     least 25 hospitals/medical centers in Turkey .      Secondary objectives are to determine the patient risk factors associated with perioperative     hypothermia, to determine the surgery risk factors associated with perioperative hypothermia,     to determine the other risk factors associated with perioperative hypothermia, intraoperative     infusion volume and effect of warming, intraoperative irrigation volume and effect of     warming, intraoperative blood infusion volume and effect of warming, to determine     complications related to perioperative hypothermia, to improve patient temperature management     awareness and processes.   "
42037|NCT02735395|"     The aim of this study was to compare the clinical and microbiological outcomes of different     dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and     amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized     chronic periodontitis (GChP).   "
41926|NCT02736838|"     Objectives: 1. To analyze the changes in peripheral tissue oxygenation in tissues subjected     to different pressure regimes in healthy humans. 2. To analyze changes in microvascular flow     in peripheral tissues subjected to different pressure regimes in healthy humans. 3. To     determine thresholds of tissue perfusion flow and transcutaneous oxygen depending on exposure     levels and angling pressure in healthy volunteers. 4. To evaluate the distribution of tissue     perfusion flow and transcutaneous oxygenation in real clinical situations in residential care     and acute hospital care in patients at risk for impaired skin integrity.      Methodology:      Experimental non-controlled, non-randomized study in two phases: preclinical and clinical.     The first phase, will be conducted in healthy volunteers and the second, in patients at risk     for impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in areas     at risk of pressure ulcers by Doppler laser will be evaluated in subjects lying on a     capacitive surface to measure pressure with 10,249 points of measurement, which will be     subject to different body systems to generate different levels of pressure and monitor     changes in tissue perfusion and oxygenation up to 4 hours, to know the implications for     repositioning interventions in patients at risk.   "
41927|NCT02736825|"     Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one     of two treatment groups. Subjects meeting all entrance criteria will receive study treatment,     then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365     days post treatment. Study images will be obtained pre-treatment, immediately post-treatment,     and at each follow-up visit for qualitative and quantitative assessments of efficacy.   "
41928|NCT02736812|"     In severe bleeding due to trauma, a fall in coagulation factors maintains and promotes     bleeding. The plasma allows, through its contribution of coagulation factors, early     prevention or correction of this post-traumatic coagulopathy. The main objective is to show     the effectiveness of pre-hospital administered FLYP during treatment of a traumatic     hemorrhagic shock, in the occurrence or the treatment of a post traumatic coagulopathy.      Study Design      This is a Randomized controlled multicenter open study in two parallel groups. Eligibility     criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood     pressure <70 mmHg] or [systolic blood pressure between 71 and 90 mmHg AND heart rate > 108],     or Shock Index >1.3 at some point in the medicalized care. Two groups of 70 patients will     receive either FLYP+ the usual treatment for post traumatic hemorrhagic shock as given in the     recommendations for best practice, or saline perfusion but no FLYP, as given in the     recommendations for best practice. The primary endpoint is the variation in the level of     Prothrombin (PR), between the PR at hospital admission and the PR originally taken in the     pre-hospital period.- The secondary endpoints are: compilation of technical and logistical     difficulties encountered before, during and after administration of FLYP ; the change in     fibrinogen level between fibrinogen level at hospital admission and fibrinogen level     originally taken in the pre-hospital period. The study must confirm the link between     causality of early administration of plasma in improving post-traumatic coagulopathy. The     study must show safe usage in out-of-hospital situations and the ability of medical staff to     meet the requirements of the health authorities in terms of product use as well as in terms     of traceability of the victims and the treatment they received.   "
41929|NCT02736799|"     The Vibrant capsule is a novel vibrating device for the treatment of gastrointestinal     disorders. The effect of different vibrations on the motor functions of the gastrointestinal     tract are unclear. The study will focus on the stomach in healthy volunteers.      The study will compare the effects of Vibrant capsule treatment and Sham capsule treatment on     gastric emptying and gastric motility in healthy volunteers.   "
41930|NCT02736786|"     This study is an observational study evaluating the clinical outcomes of mucosal sparing     proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients.     Subjects will be screened at outpatient clinic visit appointments and interested qualified     subjects will be consented and offered participation in this study. Once consent has been     obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects     will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No     study-specific visits or evaluations will be required. Patients will be evaluated according     to the physician's standard practice and discretion. Patient data will be drawn from the     patients' medical records and reported by means of a web-based electronic data collection     (EDC) system. Patients will be considered on study until 24 months of observation has     occurred, withdrawal of consent, lost to follow-up, or study closure.   "
41931|NCT02736773|"     The aim of this study is to evaluate the volume of madibular bone after placement of a     xenograft in a fresh extraction socket in human. The surgery protocol is flapless, and the     teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3     walls intact and the buccal wall at 80% . This study will include 30 patients.   "
41932|NCT02736760|"     This study is a multicenter study investigating the clinical efficacy of repetitive     daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to     prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly     allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5)     will be performed within 18 months. In the control group, cryosurgery will be performed at     visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.      In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and     other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion     preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin     layer to the whole face. Within 30 min after MAL application patients expose themselves to     daylight for 2 hours. In the control group, cryosurgery will be performed using liquid     nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at     visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by     documenting all existing and newly appearing AKs in the face.   "
41943|NCT02736617|"     This phase II trial studies how well obinutuzumab works in combination with ibrutinib in     treating patients with mantle cell lymphoma that has returned (relapsed) or that does not     respond to treatment (refractory). Obinutuzumab binds to a protein called cluster of     differentiation (CD)20, which is found on B cells and some types of leukemia and lymphoma     cells and help the immune system kill cancer cells. Ibrutinib blocks a protein called     Bruton's tyrosine kinase (BTK), which may help keep cancer cells from growing. Giving     obinutuzumab in combination with ibrutinib may kill more cancer cells.   "
41956|NCT02736448|"     This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic     neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%),     somatostatin receptor (SSR) positive and 18-FDG positive will be enrolled in the study and     will be randomly assigned to 2 different arms:        -  Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq          per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR        -  Arm Lu-PRRT: Lu-PRRT (at 3.7 gigabecquerel (Gbq) per cycle x 7 cycles) followed by          SS-LAR.   "
41933|NCT02736747|"     The stroke has been described as the third cause of death and main cause of disability in the     worldwide population. About 60% of the survivors are able to walk following the     rehabilitation process, however deficits on lower limbs functions often persists in most     cases, affecting the gait and functional mobility. In this sense, several interventions are     applied in the clinical practice to optimize the functional performance. Cryotherapy is one     of the most used techniques aiming to reduce spasticity temporarily, allowing the training of     functional tasks, such as walking. The aim of the present study is to evaluate the immediate     effects of cryotherapy (ice pack) on neuromuscular performance, proprioception, passive     resistance of dorsiflexors and plantarflexors muscles, and also on gait performance in     chronic post-stroke subjects. Eighteen chronic hemiparetic subjects will participate in this     crossover placebo-controlled trial. The order of intervention (cryotherapy or placebo) will     be randomized. Fifteen days of washout period will be considered. The cryotherapy/placebo     will be applied on the posterior area of the leg for 20 minutes. Initially Fugl Meyer will be     applied. All other assessments will be performed before and after intervention: spasticity     level, classified according to Modified Ashworth Scale; temporo-spatial and angular     parameters for trunk, hip, knee and ankle during gait, using a motion analysis system     (Qualysis AB, Gothenburg, Sweden); the proprioception (joint position sense), passive     resistance to stretching, isometric and isokinetic torques during contractions of     plantarflexors and dorsiflexors of the ankle, evaluated through isokinetic dynamometer.     Concomitantly, bilateral activation of soleus, gastrocnemius, tibialis anterior and peroneus     will be assessed by electromyography during isokinetic dynamometer assessment and gait. The     following electromyographic variables will be analyzed: maximum activation amplitude, muscle     onset, coactivation index between agonists and antagonists. For statistical analysis,     normality (Shapiro Wilk) and homogeneity (Levene) tests will be applied. If the variables     have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures     will be applied. Otherwise, non-parametric statistics (Friedman test) will be applied. A     significance level of 0.05 will be considered for all statistical tests.   "
41934|NCT02736734|"     Stress is well known to affect visceral sensitivity and gastrointestinal function in general.     A majority of patients with gastroesophageal reflux disease (GERD) report stress as an     important factor triggering symptom exacerbation. A real-life stressor could exacerbate     heartburn symptoms in GERD patients by enhancing perceptual response to esophageal acid     exposure. In Irritable Bowel Syndrome (IBS) patients, visceral hypersensitivity is a major     pathophysiological mechanism and stress is shown to trigger or exacerbate symptoms.      A possible mechanism of stress−induced visceral sensitivity could be the barrier dysfunction.     Indeed, in a study performed by our group, in human, an acute psychological stressor induces     hyperpermeability in a mast cell dependent fashion and exogenous peripheral     corticotrophin-releasing hormone (CRH) recapitulated its effects on barrier function. This     increase in intestinal permeability is a phenomenon which appears as a prerequisite for     visceral hypersensitivity. Furthermore, few studies indicate that human intestinal motility     is probably modulated by CRH. It has been shown that the brain-gut axis in IBS patients has     an exaggerated response to CRH.To our knowledge, the acute effect of exogenous CRH on     esophageal motility has not been studied before.   "
41935|NCT02736721|"     This study will evaluate the efficacy, safety and tolerability of long-term use of     peginterferon alfa-2a in participants with CML who have previously participated in     peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not     available) or ML17228 (NCT number not available) and treating physician has decided to     continue treatment with peginterferon alfa-2a within the frame of another clinical study.   "
41936|NCT02736708|"     Primary sclerosing cholangitis (PSC)        1. Prospectively validate interpretation criteria for the characterization of PSC          strictures        2. Prospectively evaluate the accuracy of pCLE for the characterization of PSC strictures          (differentiation between malignant vs. non malignant strictures), using the newly          developed interpretation criteria        3. Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures   "
41937|NCT02736695|"     This study is designed to learn more about overall tau burden in the brain of patients with     Primary Progressive Aphasia (PPA).   "
41938|NCT02736682|"     Delivery by Cesarean section is increasing worldwide and this is the most important risk     factor for post partum infection where there is a 5-20% risk of developing post partum     infection than women who deliver vaginally Provision of single dose broad spectrum     intravenous antibiotics 30-60 minutes before cesarean section has been found to be as     effective as multiple doses in reducing post operative infections. At Mulago National     referral Hospital mothers who have had elective and are at low risk of post partum infection     also receive multiple doses of intravenous antibiotics for up to 7 days. The rationale of the     study is to further inform us that single dose preoperative antibiotic prophylaxis is     effective in prevention of post operative infection in mothers delivered by elective cesarean     section.   "
41939|NCT02736669|"     This research study will compare two weight loss programs that provide different     recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in     an effort to determine if fixed calorie reduction or varied calorie reduction is more     effective for weight loss.   "
41940|NCT02736656|"     This is a multicenter, open-label extension study aimed to assess long-term safety and     efficacy of SPN-812 ER when administered alone or in conjunction with an Food and Drug     Administration-approved Attention Deficit Hyperactivity Disorder (ADHD) medication in the     treatment of ADHD in pediatric subjects who have participated in a previous blinded study of     SPN-812 ER. All pediatric subjects who complete a blinded study of SPN 812 ER will have the     option to participate in this study in which all subjects receive SPN-812 ER. After an     initial dose, subjects will enter an dose optimization phase for three to nine weeks.     Following optimization, subjects will return to the clinic every 3 months or until the     subject discontinues or the study ends at 36 months.   "
41941|NCT02736643|"     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis     of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought     to be the best screening tool for lung cancer. However, there is growing concerns about     radiation exposure, high cost, and high rate of false-positive screening result. Epidemiology     data for LDCT screening in Taiwan is lacking.      National Taiwan University Hospital Chu-Tung Branch (NTUHCT) initiated the lung cancer     screening by LDCT since June 2015. Many people can get the LDCT screening with affordable     price with the subsidy from enterprise donation. The purpose of this study is establishing     local epidemiological result via telephone follow-up and patients' medical records     retrospectively.   "
41986|NCT02736058|"     Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly     decrease the intra-operative complications as well as the maternal morbidity and mortality.     In this trial researchers aim to set up some pre-operative sonographic criteria that would     help in planning the surgical procedure as well as setting up a surgical classification for     the abnormally adherent placenta.   "
41944|NCT02736604|"     Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant     postoperative discomforts and lead to serious complications of aspiration of gastric     contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The     incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain     high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and is     associated with significant morbidity. It may also result in delayed discharge, which is     particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more     susceptible to PONV than men and breast surgery, which is primarily done in an outpatient     setting, is associated with high incidence of PONV, ranging between 15% and 84% in the     absence of prophylactic treatment.      Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the     incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms:     (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic     system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has     been demonstrated to increase the incidence of PONV in some studies but not in others. The     present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia     on the undesirable clinical outcome of PONV.   "
41945|NCT02736591|"     300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or     intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using     computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg (     DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a     placebo similar to growth hormone (GH) daily from day 6 of stimulation until the day of human     chorionic gonadotrophin (hCG) trigger. Group 2 will receive an oral placebo t.d.s. daily for     12 weeks before ICSI in addition to GH (Somatotropin, Sedico, Egypt) 4 IU on day 6 of hMG     stimulation in a daily dose of 2.5 mg subcutaneous (SC) until the day of hCG triggering.      Patients included in the study will be subjected to full history taking and clinical     examination. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will     be assessed and the antral follicular count (AFC) will be assessed using a vaginal ultrasound     scan. AFC will be defined as the number of follicles measuring 3-10mm.      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin     (hMG) stimulation until the day of hCG administration. On the day of hCG administration,     ovarian ultrasound scan will be performed using a transvaginal probe. Oocytes will be     aspirated 34-36 hours after HCG administration. Oocytes will be fertilized and embryos will     be transferred. Both groups will be compared regarding the proportion of ongoing pregnancy.   "
41946|NCT02736578|"     This phase I/II trial studies the side effects and best dose of cetuximab-IRDye 800CW when     used with intraoperative imaging and to see how well they work in finding pancreatic cancer     in patients undergoing surgery. Cetuximab-IRDye 800CW may help doctors better identify cancer     in the operating room by making the cancer visible when viewed through a special imaging     device.   "
41947|NCT02736565|"     Ewing's sarcoma characterized by the t(11; 22) (q24; q12) translocation at several but     prioritized breakpoint sites, resulting in the EWS/FLI1 fusion gene is the second most     frequently diagnosed primary malignant bone tumor in the US with an annual incidence, from     birth to age 20, of 2.9 cases per million population. The survival rate for patients with     high-risk recurrent disease (relapse < 2 years) is < 10% at 5 years. Moreover, of patients     who progress after second line treatment, eighty percent do not achieve a second complete     response and of these patients < 10% survive one year. Refractory patients to both frontline     and second line therapy have even worse prognosis.      The EWS/FLI1 gene is well known as the driver gene of Ewing's sarcoma. We designed a novel     pbi-shRNA™ EWS/FLI1 Type 1 LPX which has demonstrated sufficient specificity, safety and     efficacy in animal testing to justify Phase I testing. Clinical safety (no ≥ grade 3 product     related toxic effect) and target specific activity has been observed with other bi-shRNA     products involving 147 cancer patients (698 separate dose administrations) (BB-IND 14205;     BB-IND 14938). Moreover, safety has been observed with IV delivery of pbi-shRNA™ EWS/FLI1     Type 1 LPX in murine and swine testing via multidose IV administration.      Study testing of pbi-shRNA™ EWS/FLI1 Type 1 LPX will involve patients (≥age 8) with advanced     Ewing's sarcoma. The first 3 subjects enrolled onto the study as well as the first subject     enrolled into each dose cohort must be 16 years of age or older. pbi-shRNA™ EWS/FLI1 Type 1     LPX will be given via intravenous infusion twice a week for 4 weeks (e.g. Mon and Thurs,     preferred) for a total of 8 infusions of the product per cycle followed by a 2 week washout     period. Patients will be accrued in 3-patient dose escalation cohorts using the following     escalation schema (50% to 33% to 25% to 25% to 25%) at a starting IV dose of 0.04 mg/kg.   "
41948|NCT02736552|"     The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year     as adjuvant chemotherapy after D2 resection in patients with gastric cancer.      Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority     to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.   "
41949|NCT02736539|"     This study is designed as a randomized double-blinded treatment trial among travelers' to     geographical areas with moderate-severe rates of traveler's diarrhea. Travelers will be     randomized to receive CBS 2004 or masked placebo to be taken daily while traveling. The test     article or placebo will be taken starting 7 days prior to travel.   "
41950|NCT02736526|"     The purpose of this study is to determine the long-term effect and security of the surgical     treatment and observation only on ocular alignment, binocular stereopsis, and quality of life     in children with moderate intermittent exotropia.   "
41951|NCT02736513|"     Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be     assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.      In case of isolated CNS progression which may or may not be accompanied by asymptomatic     systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose     intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT)     will be administered; treatment with AZD9291 will be interrupted and re-initiated at a     standard dose after the end of radiotherapy course in the absence of symptomatic systemic     progression. The treatment will be continued until symptomatic systemic progression,     unacceptable toxicity or further intracranial progression following brain radiotherapy     administration (whichever occurs first). All patients will be followed until death or 5     years.   "
41952|NCT02736500|"     The aim of this phase I-II study is to evaluate the efficacy and toxicity of PRRT with     177Lu-DOTATATE (Lu-PRRT) associated to metronomic chemotherapy with Capecitabine in patients     affected by aggressive FDG-positive gastro-entero-pancreatic NET. Moreover to analyze the     effects of the capecitabine metronomic schedule on the level of circulating angiogenetic     factors.   "
41957|NCT02736435|"     The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment of     uterine fibroids in Northwestern Ontario, which is a rural and remote setting.   "
41958|NCT02736422|"     Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI)     provides novel regional functional images of the lungs. Over the past 14 years researchers at     Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been     developing and evaluating different MRI techniques to investigate different aspects of the     lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these     new methods in volunteers with healthy and diseased lungs. This proposed study is to further     test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This     protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance     imaging in the lungs and monitoring the transient changes in vital signs during and following     the gas inhalation. This includes evaluation of pulse sequences to image xenon in the heart     and brain as well as in the lungs of volunteers.   "
41959|NCT02736409|"     This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in     adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE)     who have completed participation in the SHP621-301 induction study (NCT02605837). The primary     objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of     efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire     (DSQ) score.   "
41960|NCT02736396|"     The study objective is to correlate global cognition and episodic memory performance to     resting state fMRI functional connectivity. This is a non-treatment, prospective, natural     history data collection study in a cross-sectional cohort of patients with cognitive     impairment.   "
41961|NCT02736383|"     To determine if TXA utilization is effective at reducing transfusion rates in elderly     patients undergoing surgery for treatment of a hip fractures.   "
41962|NCT02736370|"     The purpose of this observational study is to assess the rate of return to work, rate of     return to activities, functional outcome measures and pain scores in operatively repaired     rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle     fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or     before the first post-operative visit.   "
41963|NCT02736357|"     The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000     non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that     identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and     other exposures), host genetic, tumor, and treatment factors, as well as the interaction     among these factors, on short and long-term outcomes. These efforts will identify new     approaches to improve the survival and well-being of NHL patients.   "
41964|NCT02736344|"     The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug     combination product comprising:        -  Stent - mounted Cobalt Chromium (CoCr) alloy based stent        -  Delivery System - Rapid Exchange (RX) Coronary System        -  Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and polymer coating          (CarboSil®)        -  Ridaforolimus drug - Chemical Abstracts Service (CAS) Registry Number: 572924-54-0 The          product is indicated for improving coronary luminal diameter in patients with          symptomatic heart disease due to lesions in vessels with reference diameters of 2.5mm to          4.25mm, including complex lesions.   "
41965|NCT02736331|"     Primary objective is to assess the effect of the intake of different types of fruits on     memory and attention.      Secondary objective is to assess effect of intake of different types of fruits on metabolic     markers, including glucose, insulin, total cholesterol and triglyceride and the     pharmacokinetic profile of the anthocyanins.   "
41967|NCT02736305|"     Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in     angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1     Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR).     Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular     endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have     shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with     bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone     in the management of ovarian cancer both as part of frontline adjuvant treatment and as     second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been FDA     approved for the treatment of patients with metastatic colorectal cancer who have failed     prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.   "
41968|NCT02736292|"     A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in     Training: Clinical Applications, will be piloted to determine the feasibility, acceptability,     accessibility, and preliminary effects within this population.   "
41969|NCT02736279|"     Objectives: Dimethyl fumarate (DMF) therapy may cause a measureable change in bacterial     species of the gut. The primary objectives of this study are:        1. Determine whether a measureable change in bacterial species representation follows the          institution of DMF.        2. Determine whether a specific pattern of change in the microbiota phylotype with DMF          therapy correlates to onset and severity of gastrointestinal disturbances (heartburn,          nausea, flatulence, and diarrhea).        3. Determine whether any instability of microbiota phylotype representation persists          following the institution of DMF or whether stabilization relates to resolution of          gastrointestinal disturbances.        4. Determine whether there is a correlation between a pre-existing functional bowel          disorder and development or severity of gastrointestinal disturbances and of peripheral          eosinophilia.      Design: Double-blinded, prospective, single-center pilot study.      Patient Population: Individuals 18 years or older, with a confirmed diagnosis of a relapsing     form of multiple sclerosis.      Treatment Groups: This study will be an open-label prospective study design with respect to     MS immunomodulatory therapy choice. Study group will be defined as subjects with a relapsing     form of multiple sclerosis, as defined by the McDonald criteria, choosing to begin DMF     therapy.   "
42004|NCT02735824|"     Individuals with suspected primary immunodeficiency will be studied and the results compared     with healthy controls. Primary immunodeficiency may manifest as recurrent, severe or unusual     infections as well as signs and symptoms of immune dysregulation such as autoimmunity or     lymphoproliferation.   "
42005|NCT02735811|"     Multicentric, observational, retrospective registry including patients underwent ICD     implantation for any indication. The primary aim of the registry is to evaluate the long-term     outcome of patients receiving an ICD.   "
41970|NCT02736266|"     Patients with T2-T4a N0 urothelial bladder carcinoma (UBC) with residual disease after     transurethral resection of the bladder (TURB, surgical opinion, cystoscopy or radiological     presence) will receive 3 cycles of pembrolizumab (MK-3475) at the dose of 200mg 3 weekly     prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 3 weeks     of the last dose (accounting for a total of 9 weeks).      Computed tomography (CT) scan and fluorodeoxyglucose positron emission tomography     (FDG-PET)/CT scan will be done during screening and before surgery. After cystectomy,     patients with the evidence of pathologic stage T3-4 (pT3-4) and/or pathologically     node-positive disease will be managed according to local guidelines. Further anti     programmed-death (PD)-1 or anti PD-ligand 1 (PD-L1) therapy will not be given     post-operatively.      PD-L1 status will be centralized and assessed on TURB specimen using an anti-PD-L1 antibody     (Ab) and a prototype immunohistochemical (IHC) assay. PD-L1 positivity will be defined as any     staining in the stroma or in ≥1% of tumor cells.      Pathologic complete response (pCR) is the primary endpoint. All patients enrolled who receive     at least 1 cycle of study drug will be includes in the intention-to-treat (ITT) analysis.      The alternative hypothesis (H1) is pCR ≥20% and null hypothesis (H0) pCR≤10%. A 2-stage     design will be used to estimate the number of pts required. Out of 90 pts overall, with the     first stage of 49 pts, ≥6 pCR will be required in the first stage, and ≥13 pCR in the whole     study population (80% power and a 2-sided test of significance at the 10% level).      Correlative research on tissue/blood samples will include immune-cell profiling in tumor and     blood during Pembrolizumab, cytokine assessment, and molecular profiling of tumor samples.   "
41971|NCT02736253|"     In this study, it was aimed to evaluate the independent risk factors for osteomyelitis,     amputation and major amputation of the diabetic foot infection in the forward direction     without using standard scoring procedures.   "
41972|NCT02736240|"     The purpose of this study is to investigate and valuate the immunogenicity and safety of the     13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants     and toddlers (the youngest could be 6 weeks old)   "
41973|NCT02736227|"     Most patients who get a liver transplant must take immunosuppressants for the rest of their     lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney     disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug     that may stabilize or improve kidney function for patients with chronic kidney disease (CKD)     that has been caused by immunosuppressants. EVL is used for standard of care treatment to     prevent transplant liver rejection in combination with other immunosuppressants, such as     tacrolimus. The overall aim of this study is to examine a combination of two different     immunosuppressants and EVL to determine if patients may have stabilized and/or improved     kidney function without liver rejection. This study will look at how safe it is to slowly     withdraw one anti-rejection medication while continuing to take the other medicine, and     whether this can be done without liver rejection occurrence.   "
41974|NCT02736214|"     Many women and men in fertile age are at risk for sexual transmitted infections and unwanted     pregnancies, and have insufficient knowledge of health promoting lifestyle prior to     conception. There is a need to increase awareness among people in fertile age about how     sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy     outcomes. Previous studies on preconception health and care have mainly focused on women. The     aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife     could increase men's reproductive knowledge. The second aim was to evaluate men's experiences     of the intervention.   "
42001|NCT02735863|"     This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered     at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are treated with     darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI).   "
42323|NCT02731664|"     The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach,     duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of     action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper     gastrointestinal tract in man.   "
41975|NCT02736201|"     Objective: To determine the effectiveness of the capacitive diathermy in the     mechanosensitivity, morphological, functional and contractility changes in patients with     lumbopelvic pain.      Design: A pilot study, single blind, randomized controlled clinical trial, approved     previously by The Princess University Hospital Ethics Committee (Feb 11, 2016) and the     European University clinical intervention review board (CIPI/054/15).      Setting: Faculty of Health Sciences, Exercise and Sport. European University of Madrid.      Patients and intervention: A sample of 20 patients with bilateral lumbopelvic pain, between     18 and 60 years old, will be recruited and randomized into 2 intervention groups. The     instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+     T-CaRe®on; n = 10) and the instrumental manual therapy with the switched off capacitive     diathermy electrode (IMT+ T-CaRe®off; n = 10) will be bilaterally treated for 4 weeks (1     treatment per week during 10 minutes) in the lumbopelvic region.      Outcome measurements: Control variables such as the age, sex, height, weight, body mass     index, Borg scale physical activity and distress respiratory test will be measured at the     beginning of the treatment. Dependent variables such as the pain intensity, the pressure pain     threshold, the contractility, the stiffness, the adverse effects, the Oswestry and Schöber     test, as well as the ultrasound imaging cross sectional area and thickness of the skin,     subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus     anterior, externus oblique, internal oblique and transversus abdominis) will be assessed     before and after each intervention by a blinded examiner.      Analysis data: The statistical analysis will be performed with a 95% confidence interval and     the Statistic Package Social Sciences (SPSS) 22.0.   "
41976|NCT02736188|"     This open-label extension study of Ace-ER will assess the long-term safety and efficacy of     Ace-ER treatment over a period of 24 months. Approximately 165 subjects from the UX001-CL202,     UX001-CL301 and UX001-CL203 studies will be eligible to enroll in the study.   "
41977|NCT02736175|"     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular     lens implantation.   "
41978|NCT02736162|"     The primary objective of this study is to assess the retention rate of perampanel when given     as secondary monotherapy in routine clinical care.   "
42019|NCT02735629|"     The study is an investigation to assess the capacity of ascending doses of CX1739 to     antagonize the respiratory depressive effect of remifentanil. The study will also investigate     whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or alter the     BIS measure of sedation and will evaluate the safety of CX1739 when used in conjunction with     remifentanil.   "
41979|NCT02736149|"     Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World     Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening.     This study is a Phase 2, open-label, multicenter, extension study to evaluate long-term     safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study     EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind, placebo-controlled     clinical trial) and meet the eligibility criteria for Study EIG-UBX-002. The primary     objective for this study is:      - to obtain long-term safety and tolerability data for ubenimex (150 mg administered three     times daily [TID]) in patients with PAH (WHO Group 1).   "
41980|NCT02736136|"     This study aims to investigate the effects of an early intervention (joint observation and     video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who     have given birth to a very premature baby will be randomly allocated to either the early     intervention or usual care whilst the infant is still hospitalized. Participants will be     followed up at one month and six months. It is predicted that participants who received the     early intervention will report higher maternal parenting self-efficacy than those who are     not.   "
41981|NCT02736123|"     This study plans to test the pathologic complete response (pCR) rate of the combination     biotherapy regimen consisting of nivolumab plus ipilimumab versus nivolumab alone in patients     with advanced but operable melanoma. Evaluation of the presence of tumor-infiltrating CD8+ T     cells as well as that of PDL1 expression and IDO expression will be associated with clinical     response (pathologic and/or radiologic). The study will test the radiologic/clinical     preoperative response rate, recurrence free survival (RFS) and overall survival (OS). It will     evaluate the safety of neoadjuvant nivolumab and neoadjuvant nivolumab-ipilimumab. Up to 66     patients will be randomized in 1:1 ratio.   "
41982|NCT02736110|"     This registry study will compile information from patients that are scheduled to receive or     have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to     treat osteoarthritis in the knee.   "
41983|NCT02736097|"     Recently clinical guidelines categorize pneumonia in to three types: community,     healthcare-associated, and hospital-acquired. Much of the existing research to describe the     epidemiology of pneumonia in critically ill patients comes from single-center studies or from     retrospective database analyses, which limit generalizability and lead to over-prescription     of broad-spectrum antibacterial agents. This will be a prospective, multicenter     epidemiological study to characterize pneumonia epidemiology in critically ill adult     patients.   "
41984|NCT02736084|"     The investigators developed a novel, telephone-based, 12-week positive psychology     intervention and will assess its feasibility and short-term impact in adults with type 2     diabetes (T2D) and suboptimal health behavior adherence. Participants will receive a positive     psychology (PP) manual, complete exercises (e.g., writing a gratitude letter, performing acts     of kindness), and review these activities by phone with a study trainer over the 12-week     study period.      Specific Aim #1 (Feasibility and acceptability (immediate impact); primary aim): To assess     whether PP exercises administered over the phone are feasible and linked with immediate     benefit in patients with T2D, as measured by ratings provided pre- and post- each exercise.      Hypothesis: The PP exercises will be feasible (i.e., 4 of the 7 PP exercises will be     completed by a majority of participants, and participants will have a mean score of at least     7 out of 10 on ratings of ease of completion for the exercises. The PP exercises will also     have adequate immediate impact (i.e., mean ratings of 7/10 of exercise utility post-exercise     and ratings of optimism post-exercise that are significantly higher than pre-exercise).      Specific Aim #2 (Changes in clinical outcome measures): To determine whether the PP     intervention is linked to improvements in psychological well-being, during and after the     intervention period (6 & 12 weeks), via measures of optimism, gratitude, depression, and     anxiety. To examine whether the brief PP intervention is associated with improvements in     self-reported outcomes related to health (diabetes self-care, diabetes distress, health     related quality of life), during and after the intervention.      Hypothesis: Participants will have higher mean scores on all psychological outcome measures     at 6 and 12 weeks compared to baseline. Participants will also have higher mean scores on all     health-related outcome measures at 6 and 12 weeks compared to baseline.   "
41985|NCT02736071|"     Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into     three equal groups. To ensure blinding the double dummy technique will be used in which group     1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2     will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will     received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the     drugs will be given 2 hour before the procedure. An independent person will generate the     allocation sequence using computer generated random numbers.      Patient's perception of pain will be assessed for each group during the procedure,     immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).   "
42058|NCT02735122|"     This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of     1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial     products of acetaminophen 1000 mg administered as two 500 mg tablets, and ibuprofen (IBU) 400     mg following third molar (wisdom tooth) extraction.   "
41987|NCT02736045|"     Prior research has demonstrated that during residency years, in particular training to obtain     a medical specialty, work burnout is a very prevalent problem. Work burnout is defined as a     syndrome of dysfunction in three domains, emotional exhaustion, depersonalization, and a     reduced sense of personal accomplishment. (Maslach et. al., 1981). Often, burnout has been     associated with poor sleep quality and negative affectivity, such as depression and anxiety.     In fact, our preliminary data demonstrate that burnout in medical residents affects sleep     quality, and increases negative emotions. Strikingly, burnout in medical residents negatively     impacts working performance as well as patient-physician interactions, and hence may affect     the quality of health care. However, lacking are studies aimed at understating how work     burnout affects cognitive performance and decision making in medical residents. The proposed     study will provide essential groundwork in demonstrating the link between burnout and     impaired cognitive performance. In addition, the proposed study will demonstrate feasibility     for a future trial to test whether an intervention, emWave, integrating a computer based     stress management (resilience training), can have a positive impact on residents with high     burnout symptoms. The amelioration of psychological risk factors in medical residents may     lead to improved physician-patient relationships in the service of improved quality of care.   "
41988|NCT02736032|"     Traditionally, the use of GnRH-a suppression was considered essential for adequate     endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several     studies, however, have questioned its necessity for controlled endometrial preparation. Using     a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing     folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation     without GnRH-a.   "
41989|NCT02736019|"     Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and     endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the     investigators will use the double dummy technique in which group 1 will receive Tramadol     100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to     Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a     placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a     placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An     independent person will generate the allocation sequence using computer generated random     numbers.      Patient's perception of pain will be assessed for each group during the procedure,     immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).   "
41990|NCT02736006|"     Diving disorders and particularly Decompression sickness (DCS) represent a major concern in     recreational and occupational pressure-related activities. As a result of decompression from     higher to lower ambient pressure bubbles which are formed in vascular flow and in tissues     take part in embolism then resulting in DCS. Individual factors such as vascular or     respiratory defects are now considered to increase the risk of this dysbarism disease.   "
41991|NCT02735993|"     This cardiac registry study will collect information from patients with ischemic or     non-ischemic heart failure that have been treated with adipose-derived regenerative cells     (ADRCs) delivered via intramyocardial injection.   "
41992|NCT02735980|"     The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to     participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will     evaluate how the body processes the drug and how the drug affects the body. The study will     also evaluate the association between tumor response and the participant's perceived quality     of life.   "
41993|NCT02735967|"     The aim of this study will be to evaluate the effects of the use of manual therapy and     diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed     with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain     intensity and pain threshold the pressure.   "
41994|NCT02735954|"     To learn more about the positive and negative long term medical effects of marijuana use.     Information obtained during this study may identify new markers that influence the     development of lung diseases such as COPD. The Investigators are also interested in learning     more about the effects of marijuana use for insomnia and how it may or may not affect sleep.   "
41995|NCT02735941|"     The purpose of the study is to investigate phospholipid ligands and their receptors in     inflammatory bowel diseases and colon cancer. Several new species of lipids have been     recently discovered which are able to transmit information to cancer cells in the large     intestine. The lipids and their responsive receptors build an axis that is thought to     influence the development of inflammation and cancer.   "
41996|NCT02735928|"     Patients with first recurrent resistance ovarian cancer and disease progression with     peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine     the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a     combination of cisplatin and doxorubicin.   "
41997|NCT02735915|"     The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine     as well as safety up to 10 years after the first dose of initial vaccination course. This     study will also assess immune responses after re-vaccination with 2 additional doses of the     HZ/su administered at ten years after first dose of initial vaccination course from study     Zoster-003 (NCT00434577).   "
41998|NCT02735902|"     The main objective of this study is to demonstrate that a single anticoagulant therapy is     superior to a combination of anticoagulant and antiplatelet therapy on the net clinical     benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI)     according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC2 (other     complications; Kappetein et al 2012)..   "
41999|NCT02735889|"     The objective of this study is to compare the effect of different levels of carbonation     isocaloric beverages on glycemic response (using protocol based on standardized glycemic     index testing methodology), gastric emptying and satiety. It is hypothesized that carbon     dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance     satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would     have important health implications for the beverage industry.   "
42000|NCT02735876|"     This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1)     versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or     refractory (R/R) mantle cell lymphoma (MCL).   "
42002|NCT02735850|"     This will be a phase II trial testing if the combination of SBRT and L19-IL2 improves the     progression free survival in patients with limited metastatic non-small cell lung cancer     (NSCLC). Treatment will be divided in two cohorts: patients eligible for ablative     stereotactic body radiotherapy to all metastatic sites (treatment with curative intent) and     patients not eligible for stereotactic body radiotherapy to all sites (life prolongation).   "
42003|NCT02735837|"     Aim:      The purpose of this study is to investigate the effect of nonsurgical periodontal therapy     plus subgingivally doxycycline gel 3% on glycemic control in type 2 diabetes mellitus (type 2     DM) patients who have periodontitis.      Materials and methods:      A total of 24 type 2 DM patients with periodontitis will be selected for the study, and     randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type     II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than     110 have), and also with periodontal disease are chronic moderate (at least in three areas     Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical     examination and radiographic signs are being); Takes place. The initial HbA1c Patients should     be between 7-9 percent over the past three months has changed his medication also found the     necessary explanations on how to do that consent, Plaque index (PI) by Loe & Silness,     bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its     absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. Group     1: (12 patients) was treated with oral hygiene instruction, scaling and root planing, and     doxycycline gel for 15 days; and Group 2: (12 patients) has the same treatment but with     placebo gel, After 12 weeks their periodontal condition and Fasting blood sugar (FBS),     glycated hemoglobin (HbA1c) level, will be reevaluated.   "
42006|NCT02735798|"     This is a single arm pilot study of 64Cu-MM-302 and unlabeled MM-302 in combination with     trastuzumab in 10 patients with advanced HER2+ cancer with new or progressive brain     metastases. Patients will receive standard imaging at baseline, including FDG-PET/CT plus MR     brain imaging. Patients will subsequently start protocol therapy with MM-302 and trastuzumab     given on day 1 of an every 21-day dosing cycle, at the recommended phase 2 dose of 30 mg/m2.     Patients will receive 64Cu-labeled MM-302 (3-5 mg/m2 doxorubicin) three hours after unlabeled     dose of MM-302. Integrated MR/PET imaging of the brain and whole body will be performed at     two time points following 64Cu-labeled MM-302 administration: (1) within 3 hours (+/- 1 hour)     of labeled drug injection, and (2) 24 hours (+/- 6 hours) post-injection. Patients will     continue to receive subsequent doses of unlabeled MM-302 plus trastuzumab every 3 weeks until     clinical or radiographic disease progression (either in the brain or systemically) or     unacceptable toxicity, whichever occurs soonest. MR brain imaging and FDG-PET/CT scans will     be performed every 9 weeks to monitor for treatment response and disease progression.   "
42007|NCT02735785|"     The Harnessing Online Peer Education (HOPE) intervention combines social media with a     psychology-based interventions to change behavior. This intervention is being applied to     reduce prescription drug abuse among patients with chronic pain.   "
42008|NCT02735772|"     A new technique for Applying sutures to the white line in paravaginal repair.   "
42009|NCT02735759|"     The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry     device and its use in detecting circulating emboli.      Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the     device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating     emboli in vivo in patients with venous thromboembolism at diagnosis, during and after     anticoagulation therapy.   "
42010|NCT02735746|"     The purpose of this study is to to compare lung function data generated by applying High     Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic     images of the lungs breathing to determine whether different modalities of imaging provide     similar data on lung movement and function. HFFLI may detect changes in lung function in     patients undergoing External Beam Radiotherapy for cancer.   "
42011|NCT02735733|"     To determine if a balloon tamponade catheter filled with cold saline is more effective than a     catheter filled with room temperature saline in controlling post partum hemorrhage.   "
42012|NCT02735720|"     The use of TEVAR is increasing rapidly and patients even in younger patients. However,     current endografts are several orders of magnitude stiffer than the native aorta.     Pre-clinical and clinical studies have reported acute aortic stiffening after TEVAR resulting     in hypertension, elevated pulse pressure, cardiac remodeling, reduced coronary perfusion, and     finally, heart failure. These effects are markedly profound in young patients, as their     hearts and aortas are more compliant. Previous studies on adverse cardiovascular remodeling     have important limitations, such as retrospective design, use of echocardiography (with low     reproducibility and high operator-dependency), and mixed populations. A systematic assessment     of the deleterious effects of TEVAR is still missing.      The objective of this study is to perform a prospective, non-randomized controlled, study in     which blood pressure, heart rate, ECG, echocardiography, CT, MRI, intra-luminal hemodynamic     assessment, computational modeling and biomarkers are used to assess cardiovascular     remodeling following TEVAR. This study targets patients with thoracic aortic aneurysms (TAA)     or penetrating aortic ulcers (PAU) treated with TEVAR. A control group will consist of TAA     and PAU subjects who do not require endovascular treatment.      The specific aims of the study include: 1) Quantification of cardiovascular remodeling     following TEVAR in TAA or PAU patients. 2) Validation of computational modeling of thoracic     aortic hemodynamics following TEVAR using the above clinical measurements. Once validated,     computational analyses will be performed to virtually assess the impact of more compliant     endografts on cardiac and aortic hemodynamics. 3) Investigation of diagnostic accuracy of     ECG, BNP, NT-pro-BNP and Troponin T, for cardiac remodeling compared to MRI, the reference     method.      This study will assess the impact of thoracic aortic stent grafts on the cardiovascular     system through non-invasive measurements. Although there are no direct benefits for the     enrolled subjects, future aortic patients might benefit from better patient management with     improved aortic endograft designs and long-term outcomes.   "
42013|NCT02735707|"     Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia   "
42014|NCT02735694|"     This study is being conducted to determine whether cycloserine is effective for the treatment     of sleep apnea. Cycloserine is an antibiotic that has been extensively used in the treatment     tuberculosis. However, more recently it was shown to enhance memory responses. Cycloserine     may enhance the response of respiratory muscles to apnea and potentially reduce the severity     of sleep disordered breathing.   "
42015|NCT02735681|"     Meibomian glands (MG) are modified sebaceous glands associated with the tarsus (collagenous     structural component) of the upper and lower eyelids. Meibomian glands produce lipid-based     secretions which are an integral and stabilizing part of the tear film. In blepharitis and     ocular rosacea (two known causes of obstructive meibomian gland dysfunction (o-MGD),     inflammation of the lid margins causes blockage of the meibomian gland orifices, changes in     glandular secretions, and dropout of the glands themselves. This limits the production,     secretion, and quality of meibum. With less oil in the tear film, the aqueous portion of     tears is not stable and evaporates quickly which leads to dry eye.   "
42016|NCT02735668|"     The main objective of the study is to determine whether the invasive physical therapy and     motor control exercises of shoulder joint together are more effective than motor control     exercises of shoulder joint and/or shoulder conventional exercises.   "
42017|NCT02735655|"     This is a 10 minutes web based survey aims at exploring the current, global state of     digestive endoscopy training among physicians to identify what are the unmet needs and how to     improve it.   "
42018|NCT02735642|"     Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention     services.The GIRLS study will rigorously compare two 'seek' recruitment strategies, three     'test' strategies, and two enhancements to an adaptive (SMART trial design) 'linkage' to care     intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western Kenya.     Additionally, we will evaluate a scalable primary prevention messaging intervention to     support identified HIV-negative young women in reducing HIV risk and adhering to recommended     HIV re-testing recommendations. We will also conduct an economic evaluation, using cost     effectiveness analyses to determine the relative utility of each seek, test, link, and     prevention interventions.      Lessons learned will inform Government of Kenya, and other key policymakers, implementing     partners and agencies throughout sub-Saharan Africa that are exploring policies about     appropriate scale up of these multiple seek, test, link, retain, and prevention strategies to     realize the dream of an AIDS-free future for adolescent girls and young women.   "
42020|NCT02735616|"     By Investigating the heart rate variability (HRV) of 15 patients after stroke and compare it     to the HRV of 15 orthopedic patients, the investigators hope to achieve 3 main goals:      1. To describe the 24-hour circadian rhythm of heart rate among patients after stroke in the     sub-acute phase during 3 days. 2. To examine the differences in the circadian rhythm of heart     rate along 3 days between patients after stroke in the sub-acute phase and control group     matched by age and gender. 3. To describe the reaction and examine the differences in     reactions of the heart autonomic system during rest, paced breathing and activity in both     groups- stoke and control.      The HRV will be monitored by Polar watch and the activity will be measured by accelerometer,     both will be attached to the patients at the beginning of the trial and will stay on them for     3 whole days.   "
42021|NCT02735603|"     The purpose of this study is to evaluate the potential effect of naltrexone and bupropion     extended-release combination on cardiac repolarization in healthy participants.   "
42022|NCT02735590|"     Effective tuberculosis (TB) control requires that people who progress from latent     Mycobacterium tuberculosis (MTB) infection (LTBI) to TB disease are identified and treated     before they infect others. A prognostic correlate of risk (COR), based on messenger     ribonucleic acid (mRNA) expression signatures, which prospectively discriminates between TB     cases and healthy controls, has been constructed and validated. Based on published microarray     case-control datasets, the COR has 87% diagnostic sensitivity and 97% specificity for     prevalent TB disease; and in two nested case-control studies, 70% prognostic sensitivity and     84% specificity for incident TB disease occurring within one year of sampling (HIV uninfected     persons). Diagnostic and prognostic performance of the COR has not yet been tested in a     prospective cohort.      COR+ status is not directly associated with LTBI; and may, or may not, be amenable to     preventive therapy. Although effective in the short-term, preventive therapy is not     recommended for treatment of LTBI in HIV uninfected adults living in high TB burden     countries, due to rapid loss of protection; and treatment burden. A 3-month, 12-dose,     once-weekly preventive therapy regimen of high dose Isoniazid (INH) and Rifapentine (3HP) has     been recommended as equivalent to 6 months of daily INH for treatment of LTBI in low TB     burden countries by the World Health Organization (WHO).      A 'screen & treat' strategy, based on serial mass campaigns to provide targeted, short-course     preventive therapy only to COR+ persons at highest risk of TB disease, may offer the solution     for durable, community-wide protection in high TB burden countries. The efficacy of 3HP for     prevention of incident TB disease in COR+ persons has not yet been tested in a clinical     trial.      Primary Aims        1. Test whether preventive therapy (3HP) reduces the rate of incident TB disease, compared          to standard of care (active surveillance), in COR+ persons.        2. Test whether COR status differentiates persons with cumulative prevalent or incident TB          disease from persons without TB disease.      Secondary Aims        1. Estimate whether COR status differentiates persons at high risk for incident TB disease          from persons at low risk for incident TB disease        2. Compare prognostic performance of the COR for incident TB disease with Interferon-gamma          release assay (IGRA).   "
42023|NCT02735577|"     This study combines functional MRI with medication treatment in order to understand the     neural mechanisms by which disulfiram, a currently approved medication for alcohol use     disorder, changes behavior. Disulfiram is a medication that prevents drinking by causing a     highly unpleasant physical reaction when alcohol is consumed while it is being taken. Thus,     it provides a means for studying the general neural mechanisms by which awareness of risks     impacts behavior change in alcohol use disorder.   "
42024|NCT02735564|"     Bariatric surgery is considered an effective long-term intervention for the treatment of     obesity and associated complications. While bariatric surgery has been shown to result in a     large sustained weight loss, the degree of weight loss and maintenance thereafter varies     greatly. The Heads Up Surgical Demonstration Project (Heads Up) is a 5 year project examining     weight loss after an intensive medical intervention (IMI) and the 2 most widely used     bariatric surgeries (roux-en-y gastric bypass or RYGB and sleeve gastrectomy or SG). Baseline     data are collected prior to surgery and follow-up data are collected at 6 months and annually     thereafter. A recent meta-analysis revealed that RYGB resulted in greater weight loss and is     more effective in resolving obesity related comorbidities than SG, although SG has been shown     to result in a reduction of perioperative complications and reoperations1. Full elucidation     of the mechanisms leading to variation in success for weight loss interventions is crucial to     understanding the most effective and reliable treatments for obesity and associated     comorbidities.   "
42222|NCT02732990|"     Exercise intolerance is a major limiting symptom in patients with CHF. However the poor     correlation between the hemodynamic parameters of left ventricular performance at rest and     exercise performance has led to the concept that peripheral factors such as muscle perfusion     and muscle metabolism play a role as determinants of exercise capacity.   "
42025|NCT02735551|"     This prospective randomized controlled study will evaluate if Long Acting Reversible     Contraceptive (LARC) forward counseling in combination with same-day LARC placement increases     overall LARC uptake within a community college population compared to LARC forward counseling     and referral to a secondary clinic for LARC placement. The study will be conducted at Mount     Hood Community College (MHCC) in Oregon. Participants will be enrolled into three groups. All     groups will receive the same standardized contraceptive counseling (LARC forward     counseling) and participants will be able to choose between a LARC method and short-acting     method of birth control.   "
42026|NCT02735538|"     The trial detected mRNA expression of several bone repair-related genes, including Runx2, in     the femoral head and neck of patients with osteonecrosis of femoral head (ONFH) . Runx2     expression was compared with that of identical tissue from osteoarthritis patients to     identify expression in necrotic femoral head tissue, which will help clarify the role and     possible clinical significance of Runx2 in femoral head necrosis, bone repair and     reconstruction.   "
42027|NCT02735525|"     The proposed trial is a pilot to test a smartphone application (app) that will ultimately     allow patients to take and transmit photos of their postoperative wounds from home and relay     other symptom information. This protocol covers the single-institution pilot study of the     app's use in the period between hospital discharge and a patient's first follow-up clinic     visit. The investigators will recruit vascular surgery patients either preoperatively in     clinic or in the post-operative, pre-discharge period following surgery to participate in the     pilot. Using a training protocol refined in the usability-testing phase of the project,     patients will be trained to use the smartphone and the wound surveillance app prior to     discharge. Patients will use the app from home to take send digital images of their     postoperative wounds and answer a short survey, all of which will be transmitted to a secure     database maintained by the University of Wisconsin (UW) Department of Surgery and accessible     only to UW-employed study personnel. These data will be evaluated by one of three vascular     surgery service nurse practitioners (NPs) daily and entered into the medical record. Patients     who have concerning findings either in their images or in their survey answers will be     contacted for further evaluation. Smartphones will be provided to patients who do not have     one of their own, through a partnership with AT&T. Sociodemographic and comorbidity data     collected from the medical record will be kept at UW Department of Surgery on a secure server     and accessible only to UW employed study personnel.   "
42032|NCT02735460|"     Andago V2.0 is a recently developed overground gait and balance training device. Many     patients in neurorehabilitation suffer from gait disorders, most typically after stroke.     Since pharmacological therapies are basically not available, neurorehabilitation plays an     important role in the treatment of such patients. The Andago V2.0 may represent a useful     device in the rehabilitation of stroke and other neurological patients featuring a severe     gait disorder. Therefore a study has been designed to investigate the usability of the Andago     V2.0 in the setting of a neurorehabilitation clinic. The primary outcomes of this study are     the usability and acceptance of the investigational medical device (IMD). Usability is mainly     measured by the time spent for the set-up and release of the participant, achieved training     times and distances, the number of stumbles, collisions and emergency stops and the error     messages during the session. Besides patient and therapist satisfaction with the Andago V2.0     is recorded.   "
42033|NCT02735447|"     Sporadic inclusion body myositis (sIBM) is a rare idiopathic inflammatory myopathy     characterized by chronic proximal leg and distal arm asymmetric muscle weakness. Its     prevalence is estimated between 10 and 100 cases per million, over the age of 50. Little is     known about the natural course of the disease, the delay between onset and diagnosis, the     patterns of disease management and treatment in routine practice, as well as the burden for     patients.      The objectives of the PGRx-sIBM study will be to describe:        -  The epidemiology of the disease (estimation of the prevalence, age at onset, delay          between onset and diagnosis, diagnosis process, etc.)        -  The patterns of disease management and treatment in routine practice        -  The burden of the disease for patients and their informal caregiver, as well as the          quality of life of patients        -  The burden of the disease for informal caregivers      This will be an observational (non-interventional), cross-sectional (transversal) study.      Study setting The PGRx-sIBM will take place in France, Italy, Switzerland and Spain.     Recruitment centers will be public and private practices and hospitals from urban or rural     areas. In each recruitment center, at least one physician will act as a study investigator,     in charge of identifying and recruiting patients.      Inclusion of patients      Patients will be included by their specialized physician (neurologist, Internal Medicine)     during a regular outpatient visit, provided that they meet the following inclusion criteria:        -  The patient has been diagnosed with sIBM, as per the physician judgement and regardless          of the date of diagnosis        -  Male or female        -  Age ≥ 45 years old        -  The patient does regularly live in the country of inclusion        -  The patient or his/her proxy can read and respond to a telephone interview        -  The patient agrees to participate      Exclusion criteria will be:        -  The patient refuses to participate or the written Consent Form is not signed        -  The patient or his/her proxy cannot be reached by telephone. All eligible patients will          be invited to participate in the study, during a 3 to 6-month period of time.      The target sample size will be of 190 patients (≈15-20 in Switzerland, ≈50 in Spain, ≈50 in     Italy and ≈70-75 in France).   "
42059|NCT02735109|"     The confocal microscope is a noninvasive imaging technique that provides high-resolution     images to a depth of 250 microns, such as optical cuts in three dimensions in the thickness     of the skin.      This is a single-center prospective descriptive study at the University Hospital of Nice in     gynecology and dermatology.      The aim of the study is to describe the characteristics reproducibly for confocal microscope     of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma.      The patients seen in consultation with vulvar lesions suspicious looking will be included.      The results will be compared systematically to the histological results of biopsies of     lesions (gold standard).   "
42295|NCT02732041|"     Asynchrony during mechanical ventilation has been poorly described in patients suffering from     acute respiratory distress syndrome. The purpose of this study is to describe the frequency     of asynchronies (ineffective efforts and double triggering) in these group and evaluate     potential risk factors and prognosis implications.   "
42034|NCT02735434|"     Health anxiety is a prevalent, disabling disorder associated with extensive health care     expenditures. The lack of easily accessible, evidence-based psychological treatment combined     with delayed diagnostic recognition constitute barriers to receiving treatment.      Aim        1. To develop an internet-delivered treatment program, based on 'Acceptance and Commitment          Therapy' (ACT), for patients with health anxiety.        2. To test the feasibility and effectiveness of the treatment programme in a randomized,          controlled trial, comparing the treatment with an active control condition.      Methods 150 patients aged 18 years and older can self-refer through a web-page to apply for     participation. Before inclusion patients will undergo a video-diagnostic interview. Patients     are randomly assigned to 12 weeks of either, 1) active treatment: consisting of     internet-based ACT (iACT) with 7 therapist-guided modules of self-help text, exercises,     patient videos and audio-files, or 2) active control condition: consisting of an     internet-based discussion forum (iFORUM) with 7 topics of discussion.      All patients will complete self-report questionnaires at baseline, before randomization, at 4     and 8 weeks into treatment, after end of treatment, and at 6-month follow-up.   "
42035|NCT02735421|"     This is a multi-centre, randomized, investigator blinded, vehicle controlled trial using     intra-individual comparison (right half-face versus left half-face).      Subjects will have each half-face randomized to one of the two following treatments:        -  Adapalene 0.3% - BPO 2.5% gel (TactuPump® Forte).        -  Vehicle gel      The main objective of this trial is to evaluate the effect of Adapalene 0.3% - benzoyl     peroxide (BPO) 2.5% gel versus vehicle gel on the risk of formation of atrophic acne scars in     moderate to severe acne subjects.   "
42036|NCT02735408|"     Lumbar pain is a quite prevalent pathology in general population within general and sporting     population, which comes to mean high sanitary and sport costs. This concrete pain´s nature is     often unspecific, but it seems that one of the main risk factors that predispose to suffer     from it are changes in the paravertebral-lumbar musculature stiffness.      Since one decade approximately, it has proliferated, especially within sportsmen and women     the use of a therapeutic technique: the neuromuscular bandage best known as Kinesiotape (KT).     This treatment seems to accept different applications, despite there´s still a lack of     scientific evidence for several of its supposed effects. One of the theories about its use     technique is that the bandage strain generates different effects in musculature stiffness.     Thus, when the bandage is applied over the skin with a pre-stretching of the elastic bandage,     it can cause arise of stiffness and strength muscle empowerment. On the other hand, if the     bandage is applied without strain, the opposite result would appear, relaxation and strength     muscle decrease.      For trainers and therapists is important to know if the KT effect differs over the bandage     technique, since the application could be different according to the specific troubles     reported by the athletes. For example, talking about cyclists, who keep constantly a hold     rachis lumbar flexion, could be interesting to normalize the lumbar musculature stiffness, by     placing the bandage with certain strain to achieve a mechanic effect. Nevertheless, talking     about other sports like weightlifting, the bandage effect should be the stiffness arisen as a     preventive measure, for avoiding injuries derived from the lack of motor control in the     lumbar region. These lumbar-region muscle problems affect to popular and majority sports like     football, so lumbar pain is very frequently reported by football players, normally due to an     agonist-antagonist musculature unbalance. In all these terms, the use of KT would be     interesting in order to reduce the musculature strain degree.      Tensiomyography (TMG) is showing as one of the most useful and reliable instrument for the     musculature stiffness assessing, due to its velocity, harmlessness, sensing and high     reproducibility. Taking in consideration that the maximum deformity measured by the TMG is     inversely related with the muscle stiffness, and whereas this project pretends to modify that     stiffness by means of the KT application, it seems obvious that TMG is the most suitable     measurement instrument.      All these precedents considered, the present project pretends to analyze the effects of     different KT strain application along 48 hours with strains techniques of 100%, strain 50%     and strain 0% in the normalization of the paravertebral-lumbar musculature stiffness, by     means of TMG monitoring.   "
42039|NCT02735369|"     The present study is intended to evaluate the efficacy and safety of topical OC-10X     Ophthalmic Suspension in patients diagnosed with proliferative diabetic retinopathy (level     61, 65, 71, or 75). OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound,     known as OC-10X, which is a selective tubulin inhibitor under development for the treatment     of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When     administered as a topical eye drop, OC-10X has both anti-angiogenic (inhibition) and     angiolytic (regression) properties in animal models of choroidal neovascularization (CNV).     Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without     the traditional toxicity and works downstream independently of growth factors. As     demonstrated by OcuCure's preclinical data, tubulin inhibition, using OC-10X, may be a     promising new approach to the treatment of PDR and AMD. Like AMD, PDR is a major cause of     blindness in adults and is also caused by the growth of abnormal blood vessels. Importantly,     the Phase I Study found that OC-10X can be safely applied topically in human eyes without     adverse ocular or systemic effects.      Currently, there are few options for the treatment of PDR. Clinical options, such as laser     photocoagulation or vitrectomy, require surgery and can permanently impair patients' vision.     With few treatment options available, administration of OC-10X as a topical therapy, along     with its novel mechanism, has the potential to provide benefits to patients with ocular     diseases associated with angiogenesis.   "
42040|NCT02735356|"     This phase 0 trial studies how well itraconazole gel works in treating patients with basal     cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.   "
42041|NCT02735343|"     Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the     ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment     of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research     arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at     15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache     severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At     24-48 hours post intervention we will contact subjects and assess their pain and assess their     satisfaction with their migraine pain management as part of this study. Subjects'     participation will last up to 48 hours post headache.   "
42042|NCT02735330|"     To study the effect of Intra operative Coeliac plexus alcohol neurolysis combined with Frey's     procedure for effective pain relief in patients with Chronic Calcific Pancreatitis in a     single centre setting with a Randomized Controlled Trial.   "
42043|NCT02735317|"     Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The     most frequently occurred radiation-related side effect is probably the radiation-induced oral     mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy. When     severe, oral mucositis increases the risk of infection and may compromise clinical outcomes     by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. In     China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine,     is commonly prescribed when NPC patients begin to suffer from radiation-induced OM. However,     the incidence of radiation-induced OM is still quite high. Oral Ulcer Gargle (FORRAD®) is a     proprietary viscous liquid mucoadhesive hydrogel formulation. It creates a palliative barrier     over injured mucosa, to prevent and to cure radiation-induced OM. The objective of this     randomized phase II study is to assess the efficacy and safety of Oral Ulcer Gargle (FORRAD®)     as an intervention for radiation-induced OM in the treatment of NPC, compared with the     commonly used quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12,     and procaine.   "
42044|NCT02735304|"     This clinical study seeks to address four independent questions that are all part of the     delivery of care associated with the provision of a single item of treatment; an indirect     restoration (known as a 'crown') to restore and cover a damaged tooth. The provision of a     crown requires a series of sequential clinical and laboratory stages stages:        1. Stage 1 - Preliminary impression. Taking a pre-operative impression of the tooth to be          crowned. This will be used to enable the fabrication of the temporary crown after the          tooth has been prepared. This is standard care and follows established clinical          protocols.        2. Stage 2 - Preparation of the tooth. This involves cutting the tooth back to make space          for the crown that will be fabricated to replace the missing structure.        3. Stage 3 - Taking an impression of the prepared tooth. From this a duplicate model will          be made to fabricate the crown. To take the impression, the dentist will need to gently          push the gums away from the tooth by fractions of a millimeter so that the margins of          the preparation are clearly discernible.        4. Stage 4 - Provision of a temporary restoration that will provide satisfactory function          for a limited period of time, until the definitive crown can be fitted. This temporary          crown is designed to have a finite short-term durability and have an ease of manufacture          and subsequent removal; hence the use of a specific cement that will enable this.        5. Stage 5 - Fitting of the definitive restoration. This is designed to be a durable          restoration, with a mean life expectancy measured in years, but which is ultimately          determined by a number of clinical, biological and patient specific parameters.          Definitive restorations are fitted with cement designed to retain the crown in permanent          manner.   "
42045|NCT02735291|"     This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or     refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells that     have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to     tumour cells that express the EPCAM protein on the cell surface.The study will determine if     these modified T cells help the body's immune system eliminate tumour cells.The trial will     also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body     and the impact of this treatment on survival.   "
42046|NCT02735278|"     In optometry, binocular coordination is measured subjectively. The result is subjective     fixation disparity. In research different experiments have proven, that subjective and     objective fixation disparity are different. A binocular eyetracker has to be calibrated.     There are two well known calibration methods: associated and dissociated calibration.     Objective fixation disparity is measured in arcMin. Therefore, the precision of the     eyetracker plays a crucial role. Now, the investigators try to compare dissociated     calibration with polarized filters and associated calibration under different test paradigms.   "
42080|NCT02734836|"     This is a prospective, nonrandomized, single-arm study using the Zilver PTXTM stent in     patients with Superficial Femoral Artery (SFA) disease (total occlusions or significant     stenosis). 20 patients will be enrolled if they have claudication and/or critical limb     ischemia, and identifiable SFA disease on angiogram requiring percutaneous peripheral     intervention (PPI). We would like to study the vessel apposition and expansion immediately     after initial implantation as well as evaluation of late stent malapposition and neointimal     hyperplasia at the 12 months follow up after Zilver PTXTM stent implantation using     intravascular OCT imaging. Follow up visits will take place at 1 month, 6 month, 12 month and     13 month after the procedure.   "
42047|NCT02735265|"     Virtual reality balance training has already been used in stroke rehabilitation, and previous     studies supported that could improve balance ability. Although the treatment effects were     supported in studies, there are still limitations in clinical intervention and the study     power is not enough.      Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60     patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly     assign participants to standard treatment plus virtual reality group (N=30) and standard     treatment only group (N=30). There are total 12 sessions (2 times weekly) for both groups.     Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow     up in post 3 month).Investigators will also record the pleasure scale and adverse event after     every training session. Hypothesis is that Kinect for Xbox intervention can significantly     improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the     conventional rehabilitation. It may help to develop a new clinical model of virtual reality     training for patients with chronic stroke.   "
42048|NCT02735252|"     This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic     prostate cancer. Whenever possible, a new bone lesion or new/progressing soft tissue lesion     will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be     enrolled in parallel into one of five patient cohorts based modality of planned or recently     initiated systemic therapy, as well as disease setting: (A) Androgen signaling inhibitor, (B)     Immunotherapy, (C) Chemotherapy, (D) Targeted therapy, or (E) Castration-sensitive disease.     Patients in cohort E will be enrolled in one of two groups: Group 1 (treatment-naïve), and     Group 2 (pre-treated) (see previous section for definition). Patients enrolled in Cohorts     A-D, as well as Cohort E group 1, will undergo baseline tumor biopsy prior to initiation of     next line of systemic therapy. For patients enrolled in Cohort E, group 2, patients will     undergo the first tumor biopsy between 6-8 months after first dose of LHRH analogue delivered     as treatment for metastatic prostate cancer.   "
42049|NCT02735239|"     This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in     combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced     oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable     OC. The immunotherapy will be given for a 4-week period before starting the standard     chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study     will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2     (Cohorts B, C, and D).   "
42071|NCT02734953|"     Pulmonary hypertension is characterized by an increase in the pressures in the blood supply     to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall     pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary     vasculature, PVR will increase with exercise instead of decreasing as it would in normal     patients. Based on published evidence, the investigators intend to investigate the effects of     inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have     separately and previously had an implanted pulmonary artery monitoring device (CardioMems by     St Jude Medical, Inc.) placed.   "
42050|NCT02735226|"     The Shanghai Stroke Service System（4S） has been established as the network of stroke care in     greater Shanghai metropolitan area. The system includes 11 territorial-care hospitals and     their comprehensive stroke unites that provide 24h/7day acute stroke care to a population of     40 million in Shanghai. The System comprised of two consecutive phases, the acute phase that     emphasized on providing thrombolysis, and the in-hospital phase that concentrated on the     effort of recovery and secondary stroke prevention. The novel electronic data aquisition     system provides the contiguous data of clinical care of stroke patients from the acute phase     of management to inpatient rehabilitation. This system has been implemented and maintained as     an ongoing quality of stroke care project that monitored the process of routine stroke care     in Shanghai. It is funded by the Shanghai Municipal Commission of Health and Family Planning.     Our analysis of the project was approved by the Ethics Committee, which agreed that no     written informed consents were needed since the study only was consisted of a     population-based retrospective data analysis.   "
42051|NCT02735213|"     The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to     traditional laser therapy in central serous chorioretinopathy.   "
42052|NCT02735200|"     After obtaining the approval from the IRB of University of Dammam and informed consent from     550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency     were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical     examination was performed to rule out any diseases and complete blood picture, serum calcium,     phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be     done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and     ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The     participants were divided into two groups of 350 in study arm and 200 in control arm. All     participants were instructed not to change their dietary habits and life style till the study     was over. The study group of women were instructed to apply to apply Top-D (Proniosomal     Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram     of Aloe vera gel. The participants had no knowledge to which group they belong. A second     blood sample was taken at the end of 4 months and the data was entered in the data base and     analyzed using SPSS Inc version 19.   "
42065|NCT02735031|"     Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect     hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes     a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the     end-result of a process of habituation to recurrent hypoglycemia that is potentially     reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition     to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1     diabetes. This study will test the hypothesis that treatment with the GLP-1RA, exenatide,     added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with     type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled cross-over trial,     patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic     symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic     hypoglycemic glucose clamp study.   "
42092|NCT02734680|"     The purpose of this study is to find the best model of combination of intraoperative     radiotherapy(IORT) and postoperative radiochemotherapy for pancreatic cancer.   "
42053|NCT02735187|"     Patients will be screened up to 28 days before start of treatment. During the screening     visit, the purpose and procedures of the study will be explained to potential patients and     informed consent will be obtained.      At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible     patients will be randomized to treatment of the target area with either 30 minutes (group30)     or 15 minutes (group15) blue light at 600 mW/cm². Additionally, two study areas with similar     clinical symptomatology will be determined and will be randomized to blue light treated area     and Daivonex treated area.      After randomization, patients will be trained on a demonstrator device (no actual treatment     to ensure investigator is blinded as to which group the patient is randomized to) as well as     the Daivonex cream. After patients have been instructed, treatment of the areas will be     applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks.     During those 12 weeks, patients will return to the study site for safety and effectiveness     assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week     of treatment to check for any adverse events or problems in handling the device or the cream.     The visit at week 12 serves as end of treatment visit. The patients will be followed-up for     another 4 weeks. Treatment responses will be photo documented.   "
42054|NCT02735174|"     This is a pilot study to improve the partnership between Cincinnati Children's Medical Center     (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to reduce     childhood asthma in the inner city schools of Cincinnati and CCHMC. We are calling this     project asthma-free schools and bringing it to neighborhoods where the incidence of asthma     is especially high. We have designed this study to work with school-based asthma care     programs. Children with high-risk asthma will be asked to participate. High-risk will be     defined as poorly controlled asthma, frequent school absences, and/or need for daily     controller asthma medications. We will use a commercially available inhaler cap sensor to     help track medication use and symptoms through a smartphone. The study visits will be done     mostly at the school using telehealth technology similar to Skype.   "
42055|NCT02735161|"     The aims of the current study is to explore if different exercise training protocols affect     fatigue post-exercise, and if sarcoidosis-related fatigue and maximal and sub-maximal     cardiopulmonary exercise test (CPET) variables change after a 4-weeks exercise training     period.   "
42056|NCT02735148|"     Stroke is one of the most common causes of acquired adult disability. The majority of stroke     survivors have mobility difficulties such as poor standing, decreased walking speed, balance     disturbances, and increased risk for falls. Improving mobility, functional walking and     balance are the main goals of stroke rehabilitation. Robotic technologies are becoming more     promising intervention for the locomotor training in stroke rehabilitation. Static or dynamic     balance deficits act crucial role on gait performance among stroke survivors. Therefore it is     important to determine the effects of BWSTT in improving balance in persons with stroke.     Although it has been demonstrated that BWSTT improved balance and gait performance in stroke     patients, it is not clear whether the improvements are greater compared with those associated     with other gait rehabilitation methods. To the investigators knowledge, there are also     limited studies in the literature concerning the effects of BWSTT on falling risk in stroke     patients. The strong evidence is needed about the effectiveness of BWSTT including     comprehensive determinants of balance with combined and isolated intervention groups.This     study aims to compare the effects of BWSTT with combined and isolated intervention on     balance, gait and fall risk in patients with subacute and chronic stroke. The investigators     hypotheses are that after stroke:        1. the combination of BWSTT with conventional training may lead to more improved balance          parameters;        2. when applied as an isolated intervention, BWSTT or conventional training may lead to          similar results.   "
42057|NCT02735135|"     The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant     pressure mattresses in terms of peak skin pressures measured at the sacral area.   "
42296|NCT02732015|"     The goal of this clinical research study is to compare rolapitant with fosaprepitant in     controlling or preventing nausea and/or vomiting that may be caused by chemotherapy in     patients with sarcoma.   "
42060|NCT02735096|"     The human body uses vestibular feedback in coordination with visual and somatosensory     information to maintain balance and posture. However, various inner-ear disorders due to     aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular     feedback, which makes it difficult for an individual to maintain balance. This study     investigates the use of a hidden and noninvasive balance device EquiCue™ V1 developed by     Innervo Technology for vestibular substitution. EquiCue™ V1 is a retainer-like intraoral     electronic balance aid entirely worn inside the oral cavity and provides in-situ sensory     feedback of head tilting and motion on the roof of the mouth. The feedback is delivered by     applying small and controlled electrical pulses at precise locations on the palatal surface     according to an encoded pattern. This pilot study is to determine how this alternative     sensory feedback on the roof of the mouth can be used to improve balance for patients with     vestibular loss.   "
42061|NCT02735083|"     The purpose of this study is to evaluate the long-term safety and efficacy of UCART 19     administration to patients with advanced lymphoid malignancies.   "
42062|NCT02735070|"     The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the     symptomatic treatment of the common cold compared to Resfenol® comparator.   "
42063|NCT02735057|"     Management of elderly patient with cancer is a therapeutic challenge and a public health     problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women     respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other     70 % are considered unfit for surgery for various reasons, including ageing.      Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for     surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5     weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and     life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 %     respectively, in patients with a median age of 64 years. CRT has not been properly evaluated     in patients more than 75 years, and other combined chemotherapy are challenging.   "
42066|NCT02735018|"     The study aim to evaluate systemic response of patients when 2 different concentrations of     Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.   "
42067|NCT02735005|"     Heterogeneous modalities of aging lead to describe three categories of elderly patients:     1-healthy without frailty, 2- healthy with frailty, 3- patients with chronic disease(s) and     frailty. Frail people have a high risk of losing functional independence and as a consequence     they require more help for day to day life. It is known in elderly that physical activities,     nutrition, social environment are important to maintain functional independence.      For patients with disabilities, less is known about the occurence of dependance with aging.     That is of growing importance because life expectancy of disabled patients has increased a     lot during last decades, and because caregivers, often parents, also become elderly and     frail.      So the investigators will require tools to anticipate prevention and supportive needs for     this specific population.      The goal of this study is to evaluate if the participants (disabled patients over 40 years     old) of a well-defined region in the south-east of France (400000 inhabitants), and to assess     their needs, using the Functional Autonomy Measurement System (SMAF) developed for assessment     of the elderly, by Rejean Hebert & Nicole Dubuc's team in Sherbrooke University     (Quebec/Canada).   "
42068|NCT02734992|"     Research to date suggests that individuals with headache use avoidance as a way to manage     their pain. Despite the wide use of avoidance as a coping mechanism of headache triggers,     very little empirical evidence exist to support its effectiveness in headache management. New     treatment approaches, such as Acceptance and Commitment Therapy (ACT), emphasize acceptance     of headache and valued-living as alternatives to avoidance, have demonstrated preliminary     support in helping individuals reduce headache-related disability and improve quality of     life. Though, ACT has received empirical support for various chronic pain conditions, very     little evidence exists as to its effectiveness for head pain problems. The current study will     examine the effects of an ACT-based intervention when added to medical treatment as usual     (MTAU) vs. a wait list control group comprised only of MTAU, on improving quality of life and     decreasing disability among headache sufferers.   "
42069|NCT02734979|"     To investigate whether addition of the Biobridge scaffold to the standard surgery for     vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema     of the upper arm.   "
42070|NCT02734966|"     The purpose of this study is to investigate the safety, effective dosage and treatment of     Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared     with the Tiopronin Injection.   "
42072|NCT02734940|"     The investigators objective is to assess the effectiveness of an opioid sparing multimodal     approach for enhancing the recovery in Cardiac Surgical patients. This model would use a     combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine)     drugs.   "
42073|NCT02734927|"     In order to control a behaviour, investigators need to realise goal directed actions and to     priories some actions. This control is required in unusual situation. Appropriate actions are     selected and coordinated according to context and aim.      Several studies try to draw a model of executive function. Recently, Koechlin has suggested a     three levelled organisation to explain how the prefrontal cortex controls actions.      Contextual control is useful to answer appropriately with the immediate context. Episodic     control allows selecting the action according to specific information given before. Sensorial     control is the automatic response when a stimulus is presented.      Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal     cortex. Chambon and al (2008) have identified a dysfunction of contextual control in     schizophrenia.      As the prefrontal cortex is involved in motivational process, it seems interesting to study     potential links between executive function and motivation. A study from Kouneiher shows     contextual and episodic activation of motivation in healthy population.      Investigators aim to study the way motivational process are recruited in schizophrenia.   "
42074|NCT02734914|"     This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS)     with automatic control of renal pelvic pressure for the treatment of upper urinary calculi     using a prospective, randomized design. Half of participants will receive suctioning flexible     ureteroscopy with automatic control of renal pelvic pressure, while the other half     participants will receive retrograde intrarenal surgery using the classic flexible     ureteroscopy.   "
42075|NCT02734901|"     Accumulating evidence from epidemiological and human intervention studies indicates that the     cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related     to their (poly)phenol content. Raspberries are rich in phenolic and polyphenolic compounds,     in particular procyanidins, ellagitannins and anthocyanins, but also phenolic acids. At     present, a small number of randomized controlled trials investigating the effects of berry     (poly)phenols on validated surrogate markers of cardiovascular disease risk have shown     promising results. However, to date, very few human studies have specifically investigated     the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects.     Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time     in the blood and urine. Therefore, the investigators will investigate the presence of plasma     and urinary raspberry-derived metabolites 24h post-consumption. To the investigators     knowledge, the effects of red raspberry consumption on vascular function in humans have not     been investigated before. This information is necessary for the planning of long-term studies     aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims     to investigate the potential role of red raspberry (poly)phenols in the modulation of     vascular function by monitoring changes in vascular function together with the major     (poly)phenol derivatives/metabolites in plasma.   "
42076|NCT02734888|"     Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2)     Tobacco cigarette smokers, 3) Electronic cigarette users.   "
42077|NCT02734875|"     This stepped wedge randomized intervention will apply machine learning algorithms in an     electronic health record system to identify primary care patients with non-valvular atrial     fibrillation (AF) who are at high risk of stroke and not on anticoagulation therapy. An     Anticoagulant Management Service (AMS) will offer support to primary care providers regarding     treatment for relevant patients (either warfarin and novel oral anticoagulants).      This study seeks to:        1. increase the proportion of appropriately anticoagulated patients with AF,        2. understand the reasons for lack of anticoagulation, and        3. document the proportion of patients with AF who are appropriately not anticoagulated          (e.g. patient refusal, contraindication).   "
42081|NCT02734823|"     This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy     on ovarian reserve and fertility in patients with chronic myeloid leukemia or     gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone     levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more     about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.   "
42082|NCT02734810|"     Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and     amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be     formulated without enteric coating for administration either as a capsule or as a dosing     solution dissolved in water or juice. The purpose of the present study is to provide efficacy     and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral     Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).   "
42096|NCT02734628|"     The objective of the study was to investigate the efficacy of Bepanthen® wound healing     ointment compared to placebo in a superficial abrasive wound model. The primary objective was     the re-epithelization at Day 5.      The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15,     assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36     (investigator and subject), and documentation and analysis of safety parameters.   "
42097|NCT02734615|"     To characterize the safety and tolerability, identify recommended doses and regimens for     future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of     LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients     with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine     therapy.   "
42083|NCT02734797|"     Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to     comorbidities and complications that are likely to develop before, during and after     transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which     affect appetite and cause gastrointestinal toxicities that limit food intake. During     transplant, painful mucositis makes it difficult to consume adequate nutrients and often     children will require nutrition support such as parenteral or enteral nutrition. Energy     imbalance and physical deconditioning following transplant can result in loss of lean body     mass and functional impairment; these nutritional side effects are exacerbated if the child     develops graft-versus-host disease. After transplant, a substantial number of childhood     cancer survivors become overweight and develop metabolic syndrome. However, little is known     about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as     obesity), the psychosocial factors that affect dietary intake and how the quality of the     child's food intake and physical activity level throughout the transplant process might     affect body composition and clinical outcomes. In this exploratory study, we will monitor     nutritional status in pediatric patients undergoing HCT. This study will test the feasibility     of collecting patient-reported dietary intake data along with anthropometric, body     composition, functional status and psychosocial measurements that may influence dietary     intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis     will inform future interventional studies.   "
42084|NCT02734784|"     Chronic periodontitis (CP) is an infectious disease resulting in inflammation of the     supporting structures of the teeth, progressive loss of bone loss and insertion. The aim of     this study is to evaluate the effects of antimicrobial Photodynamic Therapy (aPDT) as     adjuvant to periodontal surgery treatment (PST) in patients diagnosed with generalized severe     chronic periodontitis (GSCP). Twenty patients with a clinical diagnosis of CP will be treated     in a split-mouth design study to either aPDT associated with surgical access for scaling and     root planning (SASRP) or SASRP only. aPDT will be performed by using a laser light source     with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will     occur in only one episodes. All patients will be monitored for 30 and 90 days after PST.     Clinical assessment of plaque index, probing depth, clinical attachment level and bleeding on     probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the     PST. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the     PST) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard     hybridization. Data obtained will be statistically analyzed.   "
42085|NCT02734771|"     This is a study incorporating brentuximab vedotin and dose attenuated rituximab,     cyclophosphamide, doxorubicin, and prednisone (R-CHP) into initial therapy for elderly     patients with DLBCL. Vincristine will be omitted from the standard R-CHOP regimen given the     overlapping toxicities with brentuximab vedotin.   "
42086|NCT02734758|"     This study will evaluate whether a gene marker can improve the identification of atrial     fibrillation in patients with ischemic stroke, and evaluate whether the decision to     anticoagulate could be improved by a marker of atrial fibrillation.   "
42087|NCT02734745|"     This is an open-label, mono-centre, interventional study.The aim of this trial is to assess     accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott,     CA, USA), in patients with type 1 diabetes.   "
42088|NCT02734732|"     This study will examine if a single dose of Ciprofloxacin and Trimethoprim/Sulfamethoxazole     are equivalent for prophylaxis immediately prior to prostate biopsy, when a patient has a     suspected prostate cancer.   "
42089|NCT02734719|"     Bonestim system for osteoporosis treatment uses surface electrical stimulation of     neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing     contractions of the spinal column muscles. The primary aim of this clinical study is to     determine if the Bonestim therapy can improve bone density. A secondary aim is to determine     whether the applied treatment increases postural stability and facilitation of daily life     activities.      Inducing of contractions of the spinal column muscles in this manner could be new treatment     options for the patients with reduced mobility and the patients with serious     contraindications for drugs.   "
42090|NCT02734706|"     To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242),     taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on     serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic     adults after 9 weeks of product consumption.   "
42091|NCT02734693|"     A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12     years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom     setting.   "
42094|NCT02734654|"     Background: In patients undergoing lung lobectomy, lung collapse and re-expansion after     resection is associated to severe oxidative lung injury. The researchers hypothesized that     remote ischemic preconditioning (RIPC) could reduce oxidative lung injury and improve the     oxygenation parameters.      Methods: We designed a single-centre, randomized, prospective and double-blind study,     conducted in fifty-three patients with non-small cell lung cancer undergoing elective lung     lobectomy.      Fifty-three patients were randomly assigned to 2 groups: 26 patients received limb RIPC (3     cycles: 5 min ischemia/5 min reperfusion induced by an ischemia cuff applied on the thigh)     and 27 controls.      Time course of oxidative stress marker levels was simultaneously studied in exhaled breath     condensate (EBC) and blood at four specific time points: T0, pre-operatively; T1, during     operated lung collapse and one-lung ventilation (OLV); T2, immediately after resuming     two-lung ventilation (TLV); T3, 120 min after resuming TLV.      EBC 8-isoprostane was the primary outcome. Secondary outcomes included PaO2/FiO2, other     pulmonary oxygenation variables, other oxidative markers (NO2-+NO3-, H2O2) and pH.   "
42095|NCT02734641|"     The purpose of this study is to examine whether iron therapy in patients with intravenous     iron deficiency anemia causes an increase in appetite. And whether this increase is mediated     by the hormone ghrelin.   "
42098|NCT02734602|"     This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic     density, and to determine whether ketamine administration will reverse the synaptic loss in     vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in     vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses     synaptic loss to determine whether ketamine administration could restore some of the     structural changes associated with depression and PTSD.      After a screening process to determine eligibility, all subjects will participate in an MRI,     and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive testing     and a stress test may also be done on scan days.   "
42099|NCT02734589|"     Changing the microbiota has become the most intriguing target for intervention in     inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's     disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though     dietary interventions in UC are just getting underway. However these interventions are less     likely to be effective for the more severely inflamed or refractory end of the spectrum.     Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most     studies have been unsuccessful in establishing remission and especially prolonged remission.     The investigators hypothesize that this is due to selection of random donors and the     inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful     tool to modulate the microbiota. The investigators propose to modify FT using a novel     protocol and approach that we have developed. We have developed a unique diet that is geared     to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators     intend to condition both donor and recipient with the diet to achieve optimal conditions for     transplant to succeed for both donor and recipient .The investigators intend to evaluate this     protocol in adults with active UC that are refractory to medications. The investigators will     start with a randomized controlled trial involving 76 transplanted patients, however in the     first pilot stage The investigators will enroll 34 patients, and extend the study if there is     a trend for better outcomes with the dietary conditioning protocol. Furthermore, The     investigators hope to identify successful donors during this period to use during the study     extension.   "
42100|NCT02734576|"     There have been few published studies that examine the efficacy and safety of endovascular     treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited     experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show     that venous sinus stenting could represent a viable alternative for refractory pulsatile     tinnitus patients with venous sinus stenosis. The purpose of our study is to evaluate the     safety and efficacy of this procedure in a controlled fashion, using strict inclusion and     exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to     provide robust data regarding the safety and efficacy of venous sinus stenting for patients     with pulsatile tinnitus.   "
42101|NCT02734563|"     The aim of this study was to evaluate collagen turnover in patients with multiple hernias   "
42102|NCT02734550|"     This prospective randomized multicenter study evaluates whether the decision to prescribe     antifungals guided by (1,3)-β-D-glucan in comparison to standard of care shortens time to     antifungal therapy and reduces mortality in patients with severe sepsis or septic shock and a     high risk of invasive candida infection.   "
42103|NCT02734537|"     This phase II trial studies how well radiation therapy with or without cisplatin works in     treating patients with stage III-IV squamous cell carcinoma of the head and neck who have     undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink     tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. It is not yet known if radiation therapy is more effective with     or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.   "
42104|NCT02734524|"     The main purpose of this study is to explore if the combination of autologous NK cell     infusion and chemotherapy can increase the therapeutic efficiency in the treatment of     non-small cell lung cancer compared with chemotherapy alone.   "
42114|NCT02734394|"     The purpose of this project is to help to manage the many cancer treatment side effects     through cardiovascular and resistance exercise, and education with the goal of using program     outcomes to contribute to current research.   "
42115|NCT02734381|"     The number of elderly patients admitted to the Emergency Department (ED) is dramatically     increasing.   "
42143|NCT02734017|"     The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will     be randomized in two groups:        1. group receiving a pharmacist-led standardized medication review (experimental group);          and        2. group not receiving the medication review (control group).      The patients will be followed up at 30 days after initial hospitalization. Outcome measures     include the number of readmissions; patient satisfaction, quality of medical admission     prescription and number of consultation after initial hospitalization.      Discussion: A randomized controlled trial will provide the highest level of evidence on the     impact of pharmacist-led standardized medication review on early hospital readmission for     extreme age population.   "
42105|NCT02734511|"     Relieving symptoms of patients hospitalized in a palliative care unit is a priority. Although     they receive appropriate care, they may still experience pain refractory to analgesia or/and     to conservative treatment during care procedures. For instance, pain can be caused by the     bandaging of carcinological or ischemic wounds, or by the mobilization of traumatic injuries     which cannot be specifically treated.      Although these types of situations are rare, they remain unacceptable, especially at the end     of life.      According to current recommendations, a short-term sedation treatment can be administered     although detailed procedures for this type of sedation have not been very much documented. In     reality, midalozam is often used in those cases but it has drawbacks, which is why the     investigators have looked into alternatives.      Propofol, which is already widely used in anesthesia and emergency medicine to manage painful     procedures, seems to be an interesting molecule because of its pharmacological properties. It     allows to quickly reach deep sedation and thus obtain a certain level of comfort for the     patient, but also ensures a prompt awakening as soon as care procedures are over, which     limits respiratory side effects.      The results from a preliminary study encouraged us to go further and to present a prospective     study conducted in multiple centers in order to evaluate the efficiency and safety of a     procedural sedation administered by trained doctors who are not anesthesiologists on     terminally ill patients with refractory pain hospitalized in a palliative care unit.   "
42106|NCT02734498|"     The purpose of this treatment study is to compare the effectiveness of different electrode     placements used in Electroconvulsive Therapy (ECT) in the treatment of catatonia. In this     study Electroconvulsive Therapy will be compared to medications used in the treatment of     catatonia. Medications will be administered by the primary team as part of standard of care.     Medications are not primarily being used as a part of this research study.      This treatments study, will be able to compare response rate of catatonia to right unilateral     electroconvulsive treatment (RUL ECT) and Bilateral electroconvulsive treatment (BL ECT).     Also having a control group of catatonia patients, which will not be treated with ECT will     provide additional information on early ECT treatment of Catatonia.   "
42107|NCT02734485|"     Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease,     counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely     limited in AP, therefore it would be very useful to find new ways to improve motor and non     motor symptoms in PSP. The Brainway Deep Transcranial magnetic stimulation (DTMS) is a new     technology of TMS using a particular coil, i.e. H-coil, able to stimulate deeper regions of     the brain. Only few studies in literature have evaluated the efficacy of DTMS in Parkinson's     Disease and parkinsonism; in particular in PSP patients, a case report showed an improvement     in language.   "
42108|NCT02734472|"     Essential hypertension is a complex trait which results from interaction between     environmental factors and genetic factors. The aim of this study is to investigate the     effects of interaction between environmental factors and genetic factors on long-term blood     pressure (BP) based on two established cohorts including the cohort of Hanzhong adolescent     hypertension study and the cohort of Mei county adult salt-sensitive hypertension study.     Firstly, the Hanzhong cohort-based follow-up study is designed to observe the track of BP     during the whole life time, and to explore the effects of many risk factors (such as     salt-sensitivity, obesity et al) on long-term BP and the occurrence of hypertension, and also     to analyze the relationship of different polymorphisms of sodium and potassium     metabolism-related gene with BP changes and target organ damages. In addition, by using DNA     samples collected from subjects of Mei county adult salt-sensitive hypertension studyin     which all participants had completed a chronic salt loading and potassium intervention trial,     we attempt to examine the single nucleotide polymorphisms (SNPs) of sodium and potassium     metabolism-related genes, as well as the relationship between these SNPs and BP responses to     dietary sodium/potassium intervention, long-term BP change, the risk of hypertension and     target organ damages were analyzed. This study would enable us to further explore the     etiology of essential hypertension as well as to identify new genetic markers for predicting     early hypertension and target organ damage.   "
42109|NCT02734459|"     Each patient will be randomized to receive one dose of the test article in one eye and one     dose of the reference formulations in the contralateral eye. One eye will be selected as the     initial eye for cataract surgery and aqueous humor collection and hence will be dosed and     operated on first. Followed by the second eye which will be dosed no early than a week     followed by aqueous humor collection as per specified time points and no later than 35 days     following the first eye again prior to the cataract surgery.   "
42110|NCT02734446|"     The purpose of this project is to evaluate in a randomized clinical trial, double-blind,     controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938     and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in     children with mild / moderate persistent asthma .   "
42111|NCT02734433|"     This is a Phase I, non-randomized, open-label, multiple dose study of pexidartinib in Asian     subjects with advanced solid tumors. The study will be conducted in a dose escalation to     assess the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and     preliminary antitumor activity of pexidartinib.   "
42112|NCT02734420|"     The aim of the proposed study is to assess the clinical effect of photodynamic therapy (PDT)     on dentin with carious lesions in primary teeth. Patients with primary molars exhibiting deep     carious lesions on the occlusal surface indicated for restorative treatment will be randomly     allocated to three groups: Group 1 - traditional caries removal with a low-speed drill; Group     2 - PDT + PapaMblue (carious tissue removal agent) modified with methylene blue; and Group 3     - PDT with methylene blue 0.05%. PDT will be performed with low-level laser for the treatment     of the carious tissue. Dentin samples will be removed before and after PDT for     microbiological analysis. The microbiological samples will be cultured in Brucella blood     agar, Mitis Salibarius-bacitracin agar and Rogosa SL agar. The teeth will then be restored     using high-viscosity glass ionomer cement, with clinical and radiographic follow up at six,     12 and 24 months. The data will be submitted to descriptive statistics.   "
42113|NCT02734407|"     The Endurance Trial is a Phase IV open label clinical study to assess the need for ongoing     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) endpoint.     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on     the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment     criteria will be eligible for focal laser treatment every 90 days   "
42116|NCT02734368|"     The purpose of this study is to determine the MRI characteristics of Chronic Obstructive     Pulmonary Disease subjects both at baseline and yearly for a period of 5 years, and to     correlate these biomarkers with pulmonary function tests, CT scan, 6 Minute-walk tests, and     respiratory questionnaires.      The central hypothesis is that quantitative assessment of the lung through magnetic resonance     imaging of hyperpolarized 3He can detect early alterations in structure and function which     are precursors to clinically apparent COPD and that these precursors can be used to predict     progression of disease earlier and better than established clinical methods.      Novel assessments using 3He MRI will lead to new information about COPD and will be critical     for characterizing disease response to therapy. A secondary hypothesis is that a variety of     technical improvements in the techniques of hyperpolarized gas MRI will accelerate the     translation of this relatively new modality to clinical use.   "
42117|NCT02734355|"     The objective of the study was to estimate the efficacy of telmisartan and amlodipine     combination on the restoration of left atrial mechanical function after atrial fibrillation     catheter ablation.   "
42147|NCT02733965|"     The improvement of the care pathway of oncology patients through Clinical Pharmacy activities     for outpatients (such as pharmaceutical consultation) should be implemented and evaluated.      In order to improve the care pathway of patients on anticancer oral therapies, The     investigators suggest in this research project to integrate into the medical care a Clinical     Pharmacy follow-up for the patient at the hospital in the form of pharmaceutical     consultations. These pharmaceutical consultations carried out in coordination with the     hospital clinical teams also aim to make the link between the hospital and community     pharmacists.   "
42118|NCT02734342|"     Osteoarthritis (OA) is a condition that causes cartilage loss, bony remodeling, joint     stiffness and generalized muscle weakness. 90% of OA presentation has been reported within     the leg; with 44% affecting the knee joint. Knee OA is expected to increase by 50% over the     next twenty years due to an ageing population, obesity, and societal trends such as lack of     activity. Only 13% of knee OA sufferers reach the recommended levels of exercise therefore an     understanding of how psychological and functional relationships effect exercise engagement,     which in turn would provide a more comprehensive rehabilitation programme for patients with     knee OA. The aim of this study is to investigate exercise in knee OA and it it's correlation     with fear of movement, using a mixed methods approach. Quantitative methodology will     investigate lower limb exercises for pain and function and fear of movement. The desired     outcome of the study will show that a reduction in pain with patient specific exercise will     also reduce the fear of movement and allow patients to self-manage their symptoms without     fear. Other quantitative factors such as intensity of exercise and postural stabilization     using the Y balance test will also be utilized to review the functional relationship of     muscle strength and balance to kinesiophobia. A semi-structured interview will be completed     at the end of the course of treatment to highlight what patients think about exercise as an     intervention. Participants aged forty-five and above with specific clinical symptoms will be     invited into the study and will be asked to attend eight exercise sessions within a class     environment, which will last for 1 hour within the Physiotherapy Department.   "
42119|NCT02734329|"     Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been     proved to enable tumor excision with relatively better renal function preservation comparing     with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a     randomized clinical trial in single center. The investigators want to explore this technique     to T1 RCC patients in randomized clinical trial in multiple centers.   "
42120|NCT02734316|"     The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in     patients undergoing endoscopic procedures is still not completely clear. Current European     guidelines are based on weak data. This observational study aims to evaluate the     peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.   "
42121|NCT02734303|"     Background:      The first nuclear bomb test took place in New Mexico in July 1945. This was called the     Trinity test. Researchers want to learn how it affected the health of people who lived in New     Mexico at the time of the test. To do this, they want to learn about the diet and daily life     of those people at that time. They want to study Native Americans, Hispanic/Latinos, and     non-Hispanic/Latino whites.      Objective:      To learn about the health risks for people who may have been exposed to radiation from the     Trinity nuclear test.      Eligibility:      People who:        -  Are Native American, Hispanic/Latino, or non-Hispanic white        -  Are age 70 and older        -  Lived near the fallout region of the Trinity test and know about lifestyle and dietary          patterns in New Mexico in the 1940s and 1950s      Design:      Participants will be screened with a questionnaire.      Participants will answer questions in an interview or a focus group. This will be at a place     like an office, tribal or community center, or library. It will take up to 2 hours. The     interview or group session will include:        -  Questions about their and their family members activities and eating habits in the 1940s          and 1950s        -  A card-sorting exercise: There will be cards with pictures and names of certain foods.          They will sort the cards into 2 piles: those that were consumed and those that were not.        -  Filling out a chart of their family members and the foods they ate      If participants give permission, their interview or group session will be recorded.   "
42122|NCT02734290|"     The goal of this study is to establish the safety and tolerability of pembrolizumab when     administered in combination with either of two chemotherapy regimens (weekly paclitaxel or     capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.   "
42123|NCT02734277|"     To further our understanding of the immunologic mechanisms underlying maintenance and loss of     beta cell function by evaluating the relationship between longitudinal changes in beta cell     function and changes over time in biomarkers known to be associated with a response to immune     modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov     records NCT00129259 and NCT00965458).   "
42124|NCT02734264|"     The purpose of this study will be to investigate the incidence of both Amebiasis and     cryptosporidiosis in Bangladeshi children and examine genetic variation in innate and     adaptive immunity with respect to these infections. Novel diagnostics to these infections     will also be investigated.   "
42125|NCT02734251|"     The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the     effects of Relora supplementation on responses to induced stress produced by a combination of     cognitive and physiologic stressors in healthy men and women. The effects of the supplement,     compared with a placebo, will be evaluated using measures to assess anxiety [State-Trait     Anxiety Inventory-Part 1 (STAI-Part 1), mood [Bond-Lader Visual Analog Scale (VAS)],     hypothalamic-pituitary-adrenal axis activation (salivary cortisol) and cognitive function     (cognitive flexibility, reaction time, processing speed, attention, sustained attention,     working memory, and executive function). Testing will be completed at the beginning and end     of 7-d supplementation periods with the active and placebo products to assess both the acute     effects and the acute-on-chronic effects following one week of daily use.   "
42126|NCT02734238|"     The objective of this study is to determine whether maintaining a eugonadal state, during     severe, sustained energy deficit, attenuates physiological decrements, particularly the loss     of lean body mass, and maintains mental performance.   "
42127|NCT02734225|"     Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's     proprioceptive system increasing instability. After total knee arthroplasty intervention, it     is recommended that the patient performs a rehabilitation procedure to minimize deficits     caused by surgery. In this job it is essential to insist on the importance of recovering     balance after total knee arthroplasty intervention, and assess a specifically designed     protocol to restore its function. An intervention which includes a dynamometric platform as a     training method was proposed. The randomized clinical trial compared a control group that     performed balance exercises on parallel bars, unstable plates, ramps and stairs against an     experimental group that included dynamometric platforms training as a differentiator.   "
42128|NCT02734212|"     Veterans with PTSD report that stigma and fear of stigma have a chilling effect on their     participation in mental health treatment. Despite the widely-documented effects of stigma on     the recovery of individuals with mental illnesses and research demonstrating harmful     consequences of internalized stigma, including decreased hope, self-esteem, personal     motivation, and persistence regarding illness management, no interventions are currently     available to assist Veterans with PTSD in combating the impact of internalized stigma. The     goal of this research is to develop and pilot-test an intervention to provide Veterans with     PTSD the skills to cope effectively with stigma and to mitigate the internalization of     stigmatizing beliefs and stereotypes. To accomplish this purpose, Ending Self Stigma (ESS),     an intervention composed of evidence-based methods for combating internalized stigma for     serious mental illness, will be modified and tested to address issues particular to PTSD.   "
42129|NCT02734199|"     This study aims to understand the long-term health, social, and economic impacts of     transitioning a community to Highly Effective Reversible Contraception (HER-C).   "
42130|NCT02734186|"     Background:      Schistosomiasis is a chronic infection. It is caused by parasitic worms called Schistosoma     haematobium (Sh) that are spread by snails that live in rivers. It can lead to liver problems     or bladder cancer. Praziquantel (PZQ) is a drug used to treat this infection. After taking     it, some people develop increased resistance to reinfection with Sh. Some people with Sh     infection can be infected with another worm called Mansonella perstans (Mp). Mp is spread     through a biting insect called a midge. It rarely causes symptoms. However, researchers think     that Mp infection could affect the body s response to PZQ treatment for or risk of     reinfection with Sh.      Objective:      To find out the effects of Mp infection on the response to PZQ treatment for Sh infection.      Eligibility:      Men and women ages 14-80 who:        -  Live in Tieneguebougou, Bougoudiana, or surrounding villages in Mali        -  Are not pregnant        -  Have Sh infection        -  Have no other chronic medical conditions      Design:        -  Participants will be screened with:             -  Medical history             -  Physical exam             -  Blood and urine tests             -  Stool samples        -  Participants will be treated with a single dose of PZQ by mouth.        -  After receiving PZQ, participants will return to the clinic for blood and urine tests at          the following times:             -  4, 8, 24, 48, and 72 hours later             -  5, 7, 9, and 14 days later             -  1, 3, and 6 months later      Participants who are infected with Sh at the 6-month visit will get another treatment with     PZQ.   "
42131|NCT02734173|"     There is compelling data supporting the pursuit of research into the effects of HCV     antivirals on metabolic homeostasis. As a further rationale and justification, the experience     with HIV antiretrovirals has clearly demonstrated that antiviral medications can produce     profound changes in glucose metabolism, lipid profile and other measures of metabolic     homeostasis. This establishes biological plausibility for this focus of research in HCV.      The new knowledge created from this research will:        1. Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral regimen.        2. Provide insight as to whether there are metabolic advantages with RBV-free compared to          RBV-containing HCV regimens. This is particularly relevant given the current uncertainty          regarding the need for RBV in IFN-free, oral DAA regimens.        3. Provide insight into the impact of cirrhosis on metabolic milieu before, during and          after HCV antiviral therapy   "
42132|NCT02734160|"     The main purpose of this study is to evaluate the safety and efficacy of the study drug known     as galunisertib administered in combination with the anti-programmed cell death-ligand 1     (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.   "
42142|NCT02734030|"     This study aims to compare the knee extensors' mechanical, morphological and myoelectric     properties between subjects affected by anterior knee pain and a healthy control group. The     investigators hypothesis is that patients with anterior knee pain present a reduction in the     knee extensors' mechanical, morphological and myoelectric properties due to chronic muscle     inhibition produced by the syndrome. In addition, the study also aims to evaluate whether     there are differences in methodology for application of the Interpolated Twitch Technique for     evaluation of the quadriceps muscle inhibition by comparing the use of supramaximal     electrical stimulation on the femoral nerve (gold standard) with stimulation on the motor     point (new methodology) in healthy subjects and individuals affected by anterior knee pain.     The investigators hypothesis is that the stimulation on the motor point is less     discomfortable than on the femoral nerve and muscle inhibition results are less variable     (with lower dispersion) due to such lower discomfort   "
42133|NCT02734147|"     Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis     with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult,     and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence     continues to rise, making sepsis the most expensive inpatient disease.        1. Recent research has described the therapeutic benefits associated with ascorbic acid          treatment for sepsis.        2. Researchers objectives are to perform a randomized-controlled clinical trial          investigating the ability of ascorbic acid(vitamin C) administration to decrease organ          dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in          sepsis leading to tissue hypoxia, mitochondrial dysfunction, and ATP depletion, gives          rise to organ failure.        3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death          than patients with organ failure alone. Critically ill patients may have an increased          requirement for ascorbic acid in sepsis and these patients frequently have levels below          normal. Ascorbic acid administration, has been shown to correlate inversely with organ          failure (human literature) and directly with survival (animal studies).      4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective     effect on several microvascular functions including improving capillary blood flow,     decreasing microvascular permeability, and improving arteriolar responsiveness to     vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe     sepsis is an important task as investigators continue the institutional focus on sepsis care.   "
42134|NCT02734134|"     The purpose of this study is to compare the outcomes of two different treatment options     commonly used to manage periprosthetic joint infection (PJI), an infection around the     artificial knee or hip.   "
42135|NCT02734121|"     The purpose of this study is to determine the effectiveness of a pre-consultation decision     support workshop for breast reconstruction after breast cancer, in facilitating the     decision-making process, compared to routine pre-surgical education.   "
42148|NCT02733952|"     Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In     Trans-Abdominal Myomectomy   "
42194|NCT02733354|"     Based on real cases, daily life scenarios of peritoneal dialysis and hemodialysis patients     were shooted and edited into video films, including environment of home dialysis, dietary     patterns, water intake, sports mode, daily work, short time of travel and other activities,     covering a certain natural day of either peritoneal or hemodialysis and some important time     points in the way of life, such as nursing and treatment for common complications of the     corresponding dialysis mode. The videos will also show the advantages and disadvantages of     the two modes of dialysis. According to their actual living conditions, patients will decide     the right dialysis modality that suite them well, thus improving dialysis compliance and     psychological adaptability.   "
42136|NCT02734108|"     Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite     the obvious thinness and extreme behaviors for weight loss. The result is a massive weight     loss and / or pathological thinness. The care of anorexia is difficult and few treatments     have proved to be effective in adults.      Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an     electrical current of low intensity. It allows to modulate the corticospinal excitability:     two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull     according to the region which is desired to influence the operation.      Although tDCS was shown to no noticeable side effects, it is first necessary to assess the     feasibility and safety of this technique in these physically frail patients. A recent pilot     study suggests the acceptability, safety and efficacy of tDCS program in patients with     anorexia nervosa.      Given these preliminary data and the extreme seriousness and vulnerability of patients with     resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of     this technique in patients suffering from resistant anorexia nervosa. The current data are     too preliminary to consider a randomized controlled trial, the investigators hope, initially,     replicate the data from this pilot study in a second sample with a more rigorous and     comprehensive assessment methodology .   "
42137|NCT02734095|"     A prospective, single-center, real-world study on intravascular ultrasound measurements after     percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal     lesions.   "
42138|NCT02734082|"     Many studies have shown that acute cerebral dysfunction can impair cardiac function and     autonomic control of blood pressure, heart rate and vascular tone, however, the size of the     stroke is rarely reported. Involvement of the insular cortex seems to predispose to cardiac     damage and autonomic dysfunction. However, it is not clear whether cardiac dysfunction is     merely a marker of large strokes or location of the stroke is critical.   "
42139|NCT02734069|"     This study evaluate the association of body composition (mainly free-fat mass), clinical and     biochemical parameters with development of toxicity in patients under treatment with     Carboplatin/Paclitaxel in advanced NSCLC.   "
42140|NCT02734056|"     Patient satisfaction is becoming increasingly important to hospital administrators as a     metric for quality of patient care services because it is now being linked to reimbursements     (Maher 2015). Patient satisfaction is a complex problem, and may be affected by a variety of     factors. A recent study found that higher patient satisfaction was associated with patients     who received music therapy during their hospital stay (Mandel 2014). Given that music may     positively affect patient satisfaction, we are designing a study to examine the effects of     patient-preferred music on patient satisfaction in women undergoing labor epidural placement.   "
42141|NCT02734043|"     The objective of the study is to provide a road map that can help organizational leaders     understand how to sequence their financial and human capital investments related to bundled     payment arrangements. Although specific strategies will vary between organizations, providing     evidence from a health system with extension experience bundling care for orthopedic joint     replacements can be instructive for other providers entering new building arrangements.     Insights from the experience of the health system can help other organizations prioritize     effort and focus energy around strategies that increase the likelihood of succeeding under     Comprehensive Care for Joint Replacement (CJR) and other bundled payment contracts.   "
43100|NCT02721524|"     This study aims to compare whether De Vega's Suture annuloplasty is equally effective in     reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring     annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement.   "
42144|NCT02734004|"     The purpose of this study is to look at the effectiveness, safety, and antitumor activity of     study drugs MEDI4736 in combination with olaparib. It will also examine what happens to the     study drugs in the body and investigate how well the combination between MEDI4736 and     olaparib is tolerated.   "
42145|NCT02733991|"     A premarket, international multicenter, prospective, open label, adaptive, randomized     controlled study.      The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and     SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous     insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia.     The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events     when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at     evaluating the difference in glycemic parameters and HbA1c.   "
42146|NCT02733978|"     Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and     microtrauma with high impact on quality of life, management of DUs is a great challenge for     clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone     has multiple therapeutic effects in wound healing due to the property of releasing nascent     oxygen, which has been shown to stimulate antioxidant enzymes.   "
42180|NCT02733536|"     The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed     in patients with immobilized cervical spine by unexperienced physicians.   "
42149|NCT02733939|"     This randomized controlled trial aims to recruit a total of 320 dyads composed by persons     with dementia living in community settings and their primary informal caregivers. In the     intervention group, persons with dementia will have a home monitoring kit installed in the     household while participants in the control group will receive their usual care. The kit     includes home leaving sensors, smoke and water leak sensors, bed sensors as well as automatic     lights that monitor the individual's behavior. Alerts (text message and/or phone call) will     be sent to the caregiver if anything unusual occurs. All study participants will receive     three home visits by project administrators that have received project specific training in     order to harmonize data collection. These will take place at enrollment and 3 and 12 months     following installation of the home kits. At every home visit, a standardized questionnaire     will be administered to all study participants to assess their health, quality of life and     resource utilization. The primary outcome of this trial is the amount of informal care     support provided by primary informal caregivers to the Person with Dementia.   "
42150|NCT02733926|"     This study evaluates the effect of vegetation cover on certain Interleukin-10 and     immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten     that does not have forest floor and agricultural land in the backyards, or alternatively they     will be in a kindergarten that does have forest floor and agricultural land in the backyards.   "
42151|NCT02733913|"     Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF),     however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA)     reconnection, the cause of recurrence has been not yet fully clarified.      The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It     was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore     the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have     been conducted. Some study showed the efficacy of GP ablation for AF patients.      According to the previous reports, heart rate (HR) increased, and heart rate variability     (HRV) reduced after PVI. These are considered to be due to autonomic denervation caused by     catheter ablation of GP.      For the best of investigators knowledge, there have been no data on heart rate turbulence     (HRT) of baroreflex sensitivity (BRS) concerning PVI.   "
42152|NCT02733900|"     In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis     of the femoral head and its structural evolution by the association of the micro scanner     analysis and Raman spectrometry performed on the femoral heads removed during hip     replacements. The study of femoral heads will allow the analysis of bone tissue at two     different scales, both correlated with the biomechanical properties of the bone. Also, the     association with preliminary MRI analysis will provide pathogenic explanations correlated to     these modifications.   "
42153|NCT02733887|"     The lymph nodes or masses,positron emission tomography/computed tomography (PET/CT)     standardized uptake values(SUV) results, whole body magnetic resonance imaging(MRI)     intravoxel incoherent motion(IVIM) sequence D, D*, f values and MRI volumes of lymphoma     patients were compared before and after the chemotherapy in this project prospectively to     provide data for evaluating the dependency and differences of PET/CT and whole body MRI in     lymphoma staging and therapeutic evaluation. Long-term therapeutic effect indexes obtained in     follow-up visits of patients such as Overall Survival(OS), Progression Free Survival (PFS)     etc. were used to evaluate the diagnostic sensitivity and differences of MRI and PET/CT. The     research could provide a new method of nonionizing radiation iconography for physicians to     give appropriate treatments and predict prognosis.   "
42154|NCT02733874|"     A multi-center, randomized, single blind, positive controlled trials that assess the     effectiveness, safety and cost-effectiveness analysis in patients with mild to moderate     psoriasis vulgaris and compare Compound Clobetasol Propionate Ointment to Calcipotriol     Betamethasone Ointment.      Objectives of Study：        1. Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment          in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;        2. Compare the cost-effectiveness analysis of two treatment programs.   "
42165|NCT02733731|"     Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on     senile atrophic compared as compared to estriol cream in aged woman.      Design: A randomized double-blind controlled trial.      Setting: The hospital ward.      Participants: 200 postmenopausal woman with senile vaginitis (mean age 56).      Intervention: The traditional chinese medicine oil and estriol cream were separately     intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1     month.      Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall,     vaginal discharge, and PH changes.   "
42166|NCT02733718|"     This study aims to compare the differences between three different feeding regimens on     intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.   "
42155|NCT02733861|"     With the development of oral medicine,dental implants has become a very popular solution to     remediate the loss of teeth and dental rehabilitation. For the last few decades, the     immediate loading protocol have become more and more popular because the increasing demands     of shortened treatment time. Implant stability is considered one of the most important     parameters in implant dentistry. It affects the healing and successful osseointegration of     implants. For any implant procedure, successful implant integration is a prerequisite     criterion, which depends on a series of procedure-related and patient-dependent factors. It     also has been considered that preoperative measurement is critical and may give valuable     information to predict loading time and survival of the implants.      In this clinical study, the samples were collected from patients with single teeth missing     who came from the department of prosthodontics from the School of Stomatology of the Fourth     Military Medical University.The prospective cohort study was used to investigate the     correlation between different factors and the early stability of the implants. And then,     using the correlation between different factors and the early implant stability gives     predictable data about implant stability and then evaluate the accuracy and reliability.   "
42156|NCT02733848|"     Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB)     that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB     some patients have incomplete carbohydrate absorption in the small intestine which leads to     inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators     further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and     snacks will improve carbohydrate absorption and lead to more stable glucose levels in     patients with post-RYGB hypoglycemia.   "
42157|NCT02733835|"     This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil     algorithm which would benefit labouring mothers who are unable or unwilling to receive     epidural analgesia   "
42221|NCT02733003|"     This study seeks to implement the Women's Health CoOp (Cooperative) (WHC) intervention into     HIV treatment centers (HCT), antenatal, and substance treatment clinics in South Africa to     translate the evidence-based intervention into real-world settings. Implementation, service,     and patient outcomes will be evaluated through an iterative stepped wedge design.   "
42158|NCT02733822|"     Naloxone is the standard treatment in response to cases of suspected opiate overdose.      Buccal formulation of naloxone is a novel alternative to the licensed naloxone injection     which, by removing the risk of accidental needle-stick, may be safer and easier to     administer.      Current UK policy allows the emergency administration of naloxone by any member of the     general public (Strang, Kelleher, Best, Mayet, & Manning, 2006), and the preventative     provision of naloxone to drug users and their family members (take-home naloxone) is     possible on a prescription basis. Thus, buccal naloxone may be particularly suitable for     administration by family members who are providing interim overdose management care while     awaiting the arrival of an ambulance.      The aim of this study is to examine the bioavailability and dose proportionality of buccal     naloxone compared with the licensed injection standards (intravenous, intramuscular).      The investigators hypothesise that buccal naloxone is not inferior to the injection reference     in absorption kinetics, i.e. time elapsed till peak concentration (Tmax; primary outcome),     peak plasma concentration (Cmax), overall absorption (AUC), bioavailability (F%) and,     duration of action (mean terminal half-life; T1/2).      The investigators propose a pharmacokinetic pilot investigation with within-subjects     (crossover) design, comparing two doses (0.8 mg; 1.6 mg) of buccal naloxone hydrochloride     solution to the licensed intramuscular (IM; 0.8 mg) and intravenous (IV; 0.8 mg) routes of     injection. The investigators will invite four healthy (i.e., non-opioid using) male     volunteers (n=4, not powered), each of whom will attend four experimental sessions at     counterbalanced sequence. Each volunteer will receive naloxone hydrochloride doses of 0.8 mg     IM, 0.8 mg IV, 0.8 mg buccal, and 1.6 mg buccal, with only one dose administered per session.      Blood concentrations will be measured at selected times during each session to establish     speed of naloxone absorption, time to peak concentration, estimated half-life, and overall     bioavailability. This dose-ranging pilot will inform future work by providing preliminary     data on buccal naloxone absorption into the bloodstream and by establishing feasibility of     the buccal route for naloxone delivery.   "
42159|NCT02733809|"     It has been shown previously that gene expression profiling signature (a set of dysregulated     genes) can be used for molecular classification, diagnosis, and prognosis of several types of     cancers. In This study the hypothesise that resistant tumor may be due to genetic mutations     and/or other alternative pathways that could be the reason to overcome the Sorafenib and     still proliferate.      Primary objectives To evaluate the primary and secondary potential mechanisms by which HCC     patients on Sorafenib treatment would be resistant to therapy and also identify the favorable     genetic makeup of patients responding to treatment.      Measures of primary outcome:        -  cDNA microarray analysis on the MAP kinase pathway.        -  mRNA quantification of genetic expression (RT-PCR) for identification of upregulated          genes, and confirmed by corresponding proteomic testing (by Mass Spectroscopy) in the          serum for potential serum markers. Secondary Objectives Progression free survival: Time          to disease progression in patients in Saudi Arabia with HCC receiving Sorafenib:          [defined as time, in weeks, from the baseline visit to progression of the disease or          death from any cause] will be diagnosed using the RECIST criteria based on a trimestrial          abdominal CT evaluation.        -  Survival rates and Predictors of survival:             -  Survival defined as the time from baseline visit to death from any cause [in               weeks].             -  Variables identified in multivariate regression analysis from overall treated               patients independently associated with survival till study completion or death.               Justification and Value to the Kingdom Sorafenib in the treatment of advanced HCC               is a recent development. Since the only current effective treatment for advanced               HCC is resection or transplantation and the list for these procedures are               ever-growing due to the confounding effect of the lack of infrastructure in the               Kingdom, selecting treatment for patients who are more likely to respond to               Sorafenib treatment The Long-Term Comprehensive National Plan for Science,               Technology and Innovation will help to reduce costs of managing HCC. Among Saudi               Arabia population, there are a unique set of patients here (e.g. non-alcohol               related HCC, genotype 4 HCV patients and genotype D HBV patients, high percentage               of obese patients i.e. NASH) which is different from other parts of the world.               There is increasing incidence of HCC in Saudi Arabia. Due to available expertise in               management of HCC patients in the participating institutions in the study, this               project will represent a bridge for the transfer of technology so that our research               staff and doctors will have more expertise in carrying out these techniques               independently. This study will also run in parallel to the on-going initiative to               start a HCC biobanking establishment which will provide the samples needed to carry               out our genetic studies in future. Finally, since the use of Sorafenib (at present,               the only approved treatment for advanced HCC) in the treatment of advanced HCC is a               new field, the findings of our study will have important implications in the               management of HCC, both locally and internationally.      HCC is the third most common cancer in Saudi Arabia. In 2001, HCC was the second most common     cancer affecting Saudi males and the eighth most common cancer affecting females. Most of     patients (90%) present at a more advanced stage when symptoms prevail.      Given the high prevalence of HCC in the Kingdom, it is pertinent to study why some patients     are resistant to Sorafenib compared to others. Elucidation of the differences in mechanisms     among responders and non-responders to Sorafenib therapy will enable physicians to make     better decisions in terms of treating Saudi HCC patients.   "
42160|NCT02733796|"     This is a prospective observational laboratory evaluation of the persistence rate of zika     virus (ZIKV) infection in semen by real-time Reverse Transcriptase Polymerase Chain Reaction     (RT-PCR), and assessment of ZIKV replication-competence in semen by isolation of ZIKV.     Evaluation of the persistence of ZIKV and its replication-competence in semen samples will     increase the understanding of the risk of sexual transmission of ZIKV infection in the     post-viremic phase in non-epidemic settings.   "
42161|NCT02733783|"     The primary aim of the study is to create a model; in order to examine the effects of neural     trauma in patients that are healthy individuals, induced by controlled nasal fractures during     rhinoplasty, and the regeneration process in the weeks/months that follow. This study     includes monitoring of subjective nasal symptoms with a visual analogue scale (VAS) score,     peak nasal inspiratory flow (PNIF) measurements, collection of nasal secretions and nasal     provocation (response to capsaicin and cold dry air (CDA) exposure).   "
42162|NCT02733770|"     Obesity if a health endemic problem over the entire world. Bariatric surgery is the best     chance for those patients with morbid obesity to loss weight and to maintain the loosed     weight.      Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric     by pass due to the recognized changes in the homeostasis of the hormonal secretion responsive     to the hunger status. After sleeve gastrectomy we observe many patients with thrombus of the     portal vein system. This phenomena may be attributed to changes in the portal flow due to     devascularization of the great curvature of the stomach.      The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound     before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass, were     the vascularization is not changed by the surgery.   "
42163|NCT02733757|"     Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure     (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate     the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and     ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and     peribulbar anesthesia.   "
42164|NCT02733744|"     This research study is studying an intervention called fecal microbiota transplantation     (FMT). Patients who are scheduled to undergo Hematopoietic Stem Cell Transplantation are     invited to take part in this clinical trial to undergo empiric FMT soon after hematopoietic     engraftment. The primary endpoint will be to assess the feasibility of FMT in this population     and to assess safety.   "
42186|NCT02733458|"     The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide,     pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line     treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma,     nasal type.   "
42167|NCT02733705|"     Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer.     This procedure causes pain to the patients who does not received the sedative drugs or     analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such     as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists     usually give intravenous propofol with intravenous opioids but the visual analogue score     after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown     that there was no difference in pain score between periprostatic nerve block plus opioid and     periprostatic nerve block only. So, this study is to find out whether opioids is need for     TRUS biopsy.   "
42168|NCT02733692|"     Smartphone applications and mobile technologies offer users the potential to access critical     information (e.g., proper condom use, directions to testing sites, and other sexual and     reproductive health services) when it is needed most. Relevant findings will identify areas     where existing interventions may be leveraged and adapted to work among young women of color     in an urban setting and their networks. As SRH smartphone apps continue to proliferate, this     study will expand researchers', developers', and health educators' limited knowledge about     the feasibility, acceptability and preliminary efficacy of a sexual health educational app     tailored with and for young Black and Latino women, aged 18-25 in NYC, including whether this     app acts as a gateway to sexual health educators, clinical and other service providers. If     proven effective, findings from this study will identify areas where existing interventions     may be leveraged and adapted to work among a YBLW and their networks, and potentially adapted     for other high needs communities.   "
42169|NCT02733679|"     This study aims to investigate the link between the Ataxia Telangiectasia Mutated (ATM) gene     and metformin response. This link has been identified from large studies of the human genome,     and this study aims to confirm this link in a clinical study. The ATM gene is involved in DNA     repair - if a person inherits a faulty copy of this gene from both their parents, they have     a genetic condition called Ataxia-telangiectasia (A-T).      A-T is associated with, among other things, a resistance to insulin, which causes fatty liver     and diabetes. This study will recruit people who have A-T, but have not developed diabetes,     and compare this group to healthy controls, i.e. people who do not have A-T or diabetes.     The study will compare how the groups respond to two drugs used to treat diabetes (metformin     and pioglitazone), with the intention that this will guide the management of diabetes in A-T.      This is an, open label unblinded study recruiting 15 people with A-T and 15 age and gender     matched controls. Each participant will have three study visits to the Clinical Research     Centre at Ninewells hospital in Dundee - one at baseline, a second after 8 weeks of metformin     and the final visit after eight weeks of pioglitazone. During each visit we will carry out a     number of investigations to study the insulin resistance of A-T and how it responds to     metformin and pioglitazone.   "
42170|NCT02733666|"     Lateral humeral condyle fractures are the second most common elbow fractures in children.     Displaced and rotated fractures require stabilization and reduction. Kirschner wires     (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a     new fixation method involving absorbable screws. The investigators aimed to determine if it     is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing     the functional outcomes obtained using screw fixation vs. K-wire fixation.   "
42171|NCT02733653|"     The purpose of this study is to evaluate the safety and effectiveness of the Jetstream     Atherectomy System for the treatment of Japanese patients with symptomatic occlusive     atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal     arteries (PPA).   "
42172|NCT02733640|"     The investigators sought to evaluate the influence of pantoprazole, indicated as less     effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with     stratification of the population according to the presence of cytochrome (CYP) 2C19     polymorphism.   "
42173|NCT02733627|"     The primary objective of this trial is to investigate the safety and tolerability of BI     1467335 in healthy male and female subjects following oral administration of multiple rising     doses over 28 days.      Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement     biomarkers of BI 1467335 after multiple dosing.   "
42174|NCT02733614|"     18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to     assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and     civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a     double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246     for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8     weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period     between treatments. Subjects will be assessed at baseline and then every 2 weeks during the     trial using the CAPS.   "
42175|NCT02733601|"     National, prospective, multicentre, non-interventional epidemiological study, conducted among     oncologists and breast surgeons in community and university hospitals, from the public sector     in Algeria.      The study will collect information on the characteristics, and breast carcinomas patterns of     patients whose breast cancer diagnosis was confirmed by an anatomopathologist. The study will     be conducted over a representative, but not exhaustive sample of Algerian female patients.   "
42176|NCT02733588|"     The primary objective of this study is to test an optimized control system for sensor-guided     (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical     setting in patients with severe hypoglycemia following bariatric surgery.   "
42187|NCT02733445|"     The purpose of this study was to determine how often and how likely patients are to develop     Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy     for Chronic Myelogenous Leukemia (CML).   "
42188|NCT02733432|"     The purpose of this study is to determine if two topical formulations of CD101 are safe and     effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC)     compared to oral fluconazole.   "
42216|NCT02733068|"     A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection     Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human     Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy     Females Aged 18-30 Years.   "
42177|NCT02733575|"     This study aims to develop and test the feasibility of a new therapy called Compassion     Focused Therapy (CFT) for psychosis. This therapy helps people with psychosis manage     distressing experiences by building internal feelings of safeness and affiliation, and by     providing contexts, practices and insights that facilitate the development of compassion to     self and others. The focus is on helping people feel safe in relation to their experiences     and their social worlds. CFT is a promising new approach that has been successfully provided     for people with a range of mental health difficulties. It is also firmly based in the most     up-to-date knowledge and science about how the mind works (both normally and under stress).      9 participants will be recruited from NHS psychological therapies services for people with     psychosis in South London and Maudsley (SLAM) NHS Foundation Trust. Following a short     baseline period they will receive up to 26 weekly sessions (about 6 months) of CFT with a     clinical psychologist, and will provide interview and questionnaire research data at five     different points during the study. At these assessment points, data will be gathered on     participants' experiences, mood, perceptions of their position in the social world, and heart     rate variability.      The initial therapy protocol has been developed by psychologists with expertise in CFT,     alongside people with lived experience of hearing voices and having distressing beliefs.     However, it will continue to be developed and evolve as the study progresses, and as more is     learnt (e.g. from the service-user participants) about applying the model in this population.     At the end of this study, the aim is to have all the information needed to run a randomised     controlled trial of this therapy.   "
42178|NCT02733562|"     Sleeve gastrectomy is one of the most common surgical procedures performed today for patients     that undergo bariatric surgery. One of the primary reasons for morbid obesity is unhealthy     eating habits and the belief that changes in those habits can ensure the success. Objectives:     The investigators aimed to explore the effect of different eating habits prior to the     bariatric surgery on the surgery success and on different aspect of quality of life. Design:     The investigators conducted this study on patients that underwent sleeve gastrectomy as the     first bariatric operation.   "
42179|NCT02733549|"     Dizziness is one of the most common complaints among patients admitted to the emergency     department (ED). In most cases, the etiology remains unclear. Dizziness has a broad     differential diagnosis. The initial symptoms of ALD can include many general complaints. Aim     of this study is to investigate whether SOD is a symptom of ALD, the necessity of liver     function tests for patients with SOD in the ED, and a cost analysis of liver function tests.   "
42181|NCT02733523|"     Motivations:      Socio‐economic and education determinants have a big impact on health outcomes, in terms of     worse health status in populations living in more disadvantaged conditions. Social capital,     self‐management and health literacy are some of the intermediate determinants, with the     potential to mitigate health inequalities through interventions driven by local health     agents. These three determinants are intensely interlinked and have, separately, impacts on     self‐perceived health. Social capital is defined in this project as an umbrella concept,     which includes quantitative aspects of social resources (structural social capital: social     networks and contacts, social and civic participation) as well as qualitative or subjective     aspects (cognitive social capital: perceived social support, feeling of belonging and trust)     and covers relations between subjects at a micro or individual level (family and friends) as     well as at a macro or community level. Health literacy is understood as cognitive and social     skills which determine the motivation and ability of individuals to gain access to,     understand and use information in ways which promote and maintain good health. Both are key     aspects for self‐management behaviours. The target of our research project are older people     living in urban socioeconomically disadvantaged areas, since ageing is in itself an     inequality axis and urban environments concentrate the highest health disparities.      Objectives: With the aim to reduce health inequality, an intervention has been designed to     promote self‐management, health literacy and social capital among older people who perceived     their health as fair or poor and are living in urban socioeconomically disadvantaged areas     with the aim of improving their self‐perceived health. Secondarily, the efficacy of the     intervention will be analysed in terms of increasing self‐management, health literacy and     social capital (social support and social participation), quality of life, mental health and     healthy lifestyles.      In third place, behavioural health patterns will be identified in relation to health     literacy, social capital, gender, socioeconomic and educational level, and they will be     linked to the intervention efficacy levels.   "
42182|NCT02733510|"     -  The purpose of this study is evaluating the impact of steroid pulse therapy (SPT) on SCR          revealed on PB in KT recipients maintained on TAC/MMF and corticosteroid.        -  In our institution, since routine protocol biopsies are performed at 2 weeks, 1 year,          and 2 years after renal transplantation, it is practically difficult that graft survival          is used as an endpoint for randomized controlled trials.        -  From a meta-analysis for 31 observational studies , acute rejection was associated with          an increased risk of graft loss risk ratios ranged from 1.2 - 10.5. Furthermore, chronic          allograft nephropathy and graft survival is strongly correlated with acute rejection          episode during the first year after renal transplantation.        -  Therefore, the aim of this study is to investigate the effect of early steroid pulse          therapy for the reduction of acute rejection episode during the first year after KT in          the patients who will show subclinical changes at 2-week protocol biopsy.        -  The histological feature at 1 year PB, graft function (represented by serum creatinine          level and eGFR) during the 1st year of KT were compared between SCR group and non-SCR          group.        -  Additional benefits including early detection of polioma BK virus associated nephritis          (BKVAN) and relapsed underlying disease are also evaluated.   "
42183|NCT02733497|"     Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of the     hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy     Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory     to medical treatment .      The cardiac sympathetic activity is mainly controlled by cervical sympathetic fibers but     anatomic studies have showed that accessory fibers from the T2 and T3 sympathetic ganglia     come to the heart and influence its function.      Heart Rate Variability (HRV) is a simple and non-invasive method based on electrocardiogram     to evaluate the sympathovagal balance at the sino-atrial level. Several studies have found     that ETS caused a decrease of heart rate (HR), an increase of HR variability (HRV) and a     shift of sympathovagal balance toward parasympathetic tone but remains unclear if these     changes are associated with the extend of ETS.      Thus, in the present study the investigator performed a prospective analysis of HRV function     in patients with EPH undergoing different sympathetic denervations as sympathectomy and     sympathicotomy with the hypothesis that cardiac autonomic changes could be associated with     the extend of sympathetic resection.   "
42184|NCT02733484|"     The purpose of this study is to determine whether the probiotics will be effective in the     treatment of obesity   "
42185|NCT02733471|"     This study evaluates the efficacy and safety of the administration of lidocaine spray in     oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the     other half will receive a placebo.   "
42189|NCT02733419|"     This is an open-label, randomized and multi-center study to compare the efficacy and safety     of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with     HIV-1 infection. Participants will receive an initial 28 week induction treatment with     enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to     (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be     randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24     weeks (up to Week 52).   "
42190|NCT02733406|"     Hypotension will often complicate induction of anaesthesia. The investigators want to test     the hypothesis that Target Controlled Infusion, as opposed to Velocity Controlled Infusion,     leads to less degree of hypotension.   "
42191|NCT02733393|"     The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG)     block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label     preliminary pilot study to determine if SPG block has potential utility to manage ISP in     post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.   "
42192|NCT02733380|"     This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide     combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in     relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).   "
42193|NCT02733367|"     This is a Phase 3, open-label, single-group, non-randomised, observational study of the     safety and biochemical disease control of Infacort® in neonates, infants and children with AI     who have completed study Infacort 003. All subjects who have satisfactorily completed study     Infacort 003 will be offered the opportunity to take part in Infacort 004.   "
42195|NCT02733341|"     Major heart attacks are caused by a number of factors, the two major of which are furring up     of a coronary artery with atheroma and then sudden clot formation on this area leading to a     blockage and interruption of blood flow. The clots that lead to heart attacks are largely     made of clotting blood cells (platelets) that in health repair blood vessels and inhibit     spontaneous bleeding. One of the main treatment strategies for heart attacks is to make these     cells less sticky. Aspirin is a main stay of anti-platelet treatment in the United Kingdom     (UK) and in addition one of three other oral antiplatelet agents acting on the same platelet     activation pathway (P2Y12 receptor) is licensed for use. When a patient is admitted with a     major heart attack, they are treated with emergency primary percutaneous coronary     intervention (PPCI) a technique where a wire and balloon are used to reopen the coronary     artery and then usually a stent (a slotted metal tube) is placed to keep the artery open.     Aspirin and one of the P2Y12 inhibitor agents are given to prevent further clots and all have     been shown to reduce negative events following heart attacks and angioplasty with stent     insertion. There are increasing data, including from our own institution, showing that in the     setting of heart attacks, the oral P2Y12 inhibitors are poorly absorbed and have little     effect at the time of most need, i.e. soon after dosing while the primary PCI is being     performed.      All three current P2Y12 inhibitor agents are taken in tablet form immediately before the     emergency PPCI procedure. It appears that in healthy stable patients these agents take at     least 30 min to 2 hours to have an adequate effect. In heart attack patients the angioplasty     procedure is usually performed well within this timescale. Furthermore, patients who are     having a heart attack do not have normal drug absorption with blood being diverted away from     the stomach and gut activity being suppressed by other drugs such as morphine.      In this current study, patients with major heart attacks will be given our standard oral     agent, Ticagrelor, or the newer intravenous agent Cangrelor prior to PPCI.   "
42196|NCT02733328|"     The study aims to recruit 156 (54 Acute Kidney Injury (AKI);102 non-AKI) patients undergoing     Cardio pulmonary bypass (CPB) surgery, including those with Chronic Kidney Disease (CKD) and     multiple co-morbidities. Urine and blood samples collected pre-operatively and then 0, 3, 6     and 18 hours post-CPB will be stored at -80oC until batch analysed for NGAL using the Abbott     and BioPorto assays. AKI - defined as a ≥50% rise in serum creatinine (SCr) over baseline, or     the requirement for renal replacement therapy (RRT). SCr will be measured pre-operatively     (baseline), then 12 hourly for the first 48 hrs post-CPB and thereafter 24 hourly for 5 days.     Clinical data collected will include patient demographics, co-morbidities, drug history,     pre-operative renal function, surgery details (type, length, CPB time etc.), length of     Intensive treatment unit and hospital stay and post-operative complications. Data will then     be analysed comparing the two NGAL tests to find out which is superior, whether it is better     to use blood or urine and to define optimal NGAL cut-offs and sample timing for predicting     AKI. Both the Abbott and BioPorto assays will subject to a laboratory method evaluation prior     to the analysis of any patient specimens in order to verify that their performance is     acceptable and meets the manufacturer's claims. This will involve measuring the standard     parameters used to assess laboratory assay performance e.g. imprecision (reproducibility),     linearity, recovery and method comparison etc.   "
42197|NCT02733315|"     The Diabetes Conversation Map Program (DCMP) is a novel, group-based, interactive diabetes     management education program that has been shown to help patients adapt to their disease. So     the investigators aimed to examine the long-term effectiveness of the DCMP among diabetes     patients in Taiwan.   "
42198|NCT02733302|"     The control of diabetes is related both to food, treatment but also to physical activity.     Despite these recommendations and these positive findings, patients are always sedentary     because of brakes in the practice of a regular physical activity.      It is therefore interesting to consider the representations of patients and particularly on     the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the     sum of the will and means that an individual has to achieve its goals. Will be discussed in     this study to identify a relationship between the level of hope for patients and their     ability to permanently change their behavior in regular physical activity as part of the     goals set during the week of therapeutic education patient.   "
42199|NCT02733289|"     Standard evaluation and follow-up data regarding complications of curative radiation     treatment for cervical cancer.   "
42200|NCT02733276|"     Fatigue is a common symptom in inflammatory bowel diseaseI and persists despite clinical     remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.     Acupuncture has been shown useful in the treatment of fatigue in various chronic diseases.      This study evaluates the effect of electroacupuncture in the treatment of fatigue in patients     with quiescent inflammatory bowel disease.      Patients with inflammatory bowel disease and severe fatigue (FACIT-F score <38) who agree to     participate in the study will be randomized to three different treatments: electroacupuncture     vs. sham electroacupuncture vs. control group.   "
42215|NCT02733081|"     This is a randomized controlled trial that compares traditional IUD insertion with that of a     no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD     placement is safe and effective without pre-procedural assessment of uterine size, direction,     or depth.   "
42201|NCT02733263|"     Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal bulk     by enhancing growth of specific microbial populations; however the effect of RMD on     bifidobacteria and total fecal weight is not clear. The purpose of this research study is to     determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce     beneficial changes in gastrointestinal function, the fecal microbiota profile (increased     number of healthy bacteria in stool) and immune processes resulting in improved quality of     life.   "
42202|NCT02733250|"     The purpose of this study is to determine the optimal dose of nab-paclitaxel to be safely     administered in combination with pembrolizumab in patients with advanced inoperable non-small     cell lung cancer. The study is also aimed at evaluating the efficacy of the combination     therapy.   "
42203|NCT02733237|"     To investigate whether intranasal oxytocin (40 IU) treatment can influence the tolerance of     infidelity in males and females.   "
42204|NCT02733224|"     we intend to evaluate the association between non-adherence to Lenalidomide in Multiple     Myeloma (MM) patients and overall response rates and time to progression (TTP).      Adherence will be measured in several ways, including by electronic monitoring, which is the     gold standard method.   "
42205|NCT02733211|"     The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes     mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial     glucose to aid in the management of their diabetes. The product automatically adjusts basal     insulin delivery and delivers correction boluses in response to real-time glucose     measurements by CGM to maintain blood glucose within the desired range, to improve metabolic     control without increasing the risk of hypoglycemia.      The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the     safety and efficacy of night closed-loop control using the MD-Logic automated insulin     delivery system compared to sensor augmented pump therapy in poorly controlled patients with     type 1 diabetes at home The objective of this pilot study is to evaluate the safety and     efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly     controlled type 1 diabetes at patient's home   "
42206|NCT02733198|"     To evaluate the effect of a prognosis-guided vs standard medical therapy in the: 1) duration     of hospital stay; 2) cost-effectiveness; 3) satisfaction and quality of life; 4) in-hospital     and 30-day all-cause mortality; and 5) 30-day readmissions in normotensive patients with     acute symptomatic pulmonary embolism (PE).      Design: Prospective, randomized, controlled, single blind trial. Normotensive patients with     acute symptomatic PE will be randomly assigned to follow a prognosis-guided treatment, or to     receive usual care.      Setting: Respiratory, Medicine and Emergency Departments in 15 Spanish hospitals.      Analyses: Data for the primary and secondary end points will be analyzed according to the     intention-to -treat principle. The intention-to-treat analysis will include all randomly     assigned patients. For the efficacy end points, investigators will use the Mann-Whitney U     test. We will also use competing risk regression models according to Fine and Gray. For the     safety end points, comparisons will be made with the use of the chi-square test. Separate     analyses will be done in key prespecified subgroups of patients, according to age and     hospital size.   "
42207|NCT02733185|"     Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled     factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and     minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial     infarction (MI).   "
42208|NCT02733172|"     The investigators plan to extensively phenotype a large sample of Vulvodynia (VD) patients     using functional and structural brain imaging together with genetic, physiological, and     biological parameters.   "
42209|NCT02733159|"     This study is to determine that pembrolizumab is safe and tolerable at the selected dose for     the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of     2. All patients will receive pembrolizumab.   "
42210|NCT02733146|"     To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones     in cardiac arrest patients.   "
42211|NCT02733133|"     This study will assess the potential of Testagen® TDS-Testosterone to enable transfer of     Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has     been applied and the potential of product to raise serum androgen levels in those women.   "
42212|NCT02733120|"     The objective of this study is to gain preliminary information and knowledge on metabolic     profile in ASD. The benefit of this study will be to expand our insight of the potential     relationship in metabolic processes and neuropsychological functions in ASD. For example,     based on the obtained data of the study we can determine whether there is a link between the     tryptophan pathway and cognitive functions in autism. The project is based on a systematic     and multidisciplinary approach using tracers for delineating the mechanism by which the     metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD.     Using an innovative approach to the evaluation of amino acids has not been used in adults     with ASD. In addition, the obtained data of the study holds promise to develop specific     markers (metabolic and/or neuropsychological) for guiding the identification those     individuals with increased risk of developing mood disturbances or cognitive impairment, and     for predicting the therapeutic effect of a specific nutritional interventions in subjects     with ASD.   "
42213|NCT02733107|"     The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer     treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular     endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung     cancer which is recommended by NCCN guideline. The investigators wondered whether these two     drugs have synergistic effects when treating advanced non-small cell lung cancer patients who     failed to previous at least 2nd line treatments. Thus, the aim of this trial is to     investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated     advanced non-small cell lung cancer.   "
42214|NCT02733094|"     The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17     therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration     until week 16) for the treatment of pyoderma gangrenosum.   "
43253|NCT02719522|"     This is a prospective, single-arm, multi-center post-market observational study assessing the     performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects     undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.   "
42217|NCT02733055|"     Determine the effects looking in certain direction or moving the eyes in a certain way have     on the ability of a subject to maintain equilibrium in different circumstances (eyes     open/closed, and standing on hard or compliant surface, with the head straight or rotated     right or left, flexed or extended).   "
42219|NCT02733029|"     The purpose of this study is to determine the feasibility and efficacy of detecting kidney     transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid.   "
42220|NCT02733016|"     Seinäjoki Adult Asthma Study is a single-centre 12-year follow-up study of a total cohort of     259 patients having new-onset asthma that was diagnosed at adult age. The study was divided     in two parts: the collection of the original cohort (phase I;n=259) and follow-up visit     (phase II; n=203). The aim of this study is to increase the understanding on the diagnostics     and diagnostic process, organisation of the long-term asthma care, therapeutic outcomes,     prognosis and the factors affecting the prognosis of new-onset asthma diagnosed at adult age.   "
42223|NCT02732977|"     Heart failure is a growing throughout pathology in Europe. It is a public health issue and an     economic issue. The management to be effective needs to be early but specific. Generic     treatment (medication, rehabilitation, hygienic dietary measures) known for over 15 years and     has demonstrated its effectiveness, come s'ajouter solutions specific, technically complex     and expensive to implement. Because of the potential risk to the patient and their cost to     the company, these new techniques need to be adapted to each case. The passage of a generic     simple treatment for everyone in the single treatment tailored to each patient requires     decision support tools for the clinician. These tools or decision trees are developed using     mathematical and statistical models fed by all patient data (imaging, biology physiology ...)     before and after implementation of treatment. Predictive response models of a treatment     applied to a particular pathology can thus be generated.      It is this type of models applied in systolic heart failure complicated by mitral     regurgitation and / or cardiac synchronization that will be generated in this project from     150 patients included in 3 European clinical studies (London, Brussels, Caen). In Caen we     will include 30 patients in this single-center study   "
42224|NCT02732964|"     The aim of this study is to evaluate the effect of perioperative music on maternal anxiety,     hemodynamic response to spinal anesthesia, postoperative pain medication requirement, and     overall maternal satisfaction.      Investigators hypothesize that women exposed to perioperative music will have greater overall     satisfaction with the delivery experience. Investigators also hypothesize that perioperative     music will lower anxiety levels of women having a scheduled cesarean delivery, result in a     less profound degree of spinal-induced hypotension prior to cesarean delivery, and result in     a lower requirement of analgesics postpartum.   "
42225|NCT02732951|"     This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal     thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12     weeks in patients with mild vision impairment due to center-involved DME   "
42226|NCT02732938|"     The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of     PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the     dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309     and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the     enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine     versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.   "
42227|NCT02732925|"     The purpose of this study is to determine whether surgical treatment, balloon kyphoplasty is     more effective compared to conservative treatment alone (sham procedure) when assessing     clinical, translational, radiological & patient outcomes in patients with multiple myeloma.      Subjects will be recruited to the study if they have VAS score ≥ 6 and has given informed     consent to participate in the Melody Study will be randomised to Arm 1 Sham Procedure and     Conservative treatment or Arm 2 Balloon Kyphoplasty and Conservative treatment. Subjects     recruited to Arm 1 (Sham Procedure and Conservative treatment) can cross over into Arm 2     (Balloon Kyphoplasty and Conservative Treatment) if they have a VAS score ≥ 6 between 8-12     weeks.   "
42228|NCT02732912|"     The aim of this study is to determine whether routinely providing patients admitted to     hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients     having a better quality of sleep and/or longer, more satisfying sleep.   "
42229|NCT02732899|"     To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA     in subjects with exudative age related macular degeneration (AMD) with persistent     intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal     anti-vascular endothelial growth factor (antiVEGF) treatment.   "
42230|NCT02732886|"     This study is to compare the efficacy and safety of Medifoam® and Betafoam®, which is a new     dressing that contains povidone-iodine, in patients with diabetes foot ulcer. 70 patients (35     each arm) are targeted to be enrolled in this study. Treatment follow periods are 8weeks.   "
42231|NCT02732873|"     The REKREATE project will be an international, multi-centre, non-randomised, prospective     single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold     following the provision of informed consent. A study period of 1 year and extended follow up     period of up to 3 years is planned , to enable a thorough and complete assessment of the     performance of the device when implanted to replace removed or damaged meniscal tissue in     humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold,     which has been developed for repair of defects of the meniscus.   "
42232|NCT02732860|"     By obtaining clinical specimens from participants with triple negative breast cancer (TNBC),     colorectal cancer (CRC) and other select tumor types to establish and profile as freshly     implanted tumors in mice, the aim of this study is to identify agents with predicted activity     in the host patient while also potentially providing them with personalized cancer treatment     options   "
42233|NCT02732847|"     Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract     infections (which are mostly viral).      This trial will test the hypothesis that if the clinician post-dates the delayed prescription     by 2 days, rather than dating it on the day the patient is seen, there will be a further drop     in the rate of antibiotic use.   "
42234|NCT02732834|"     The purpose of this study is to better understand communication between patients with lung     cancer and their doctors. The investigators are also interested in patient's perceptions of     the quality of communication with his/her doctor and how these perceptions may impact patient     outcomes. The doctor is participating in this study and has given us permission to approach     his/her eligible patients for study participation.   "
42235|NCT02732821|"     This study is performed to study Gastric Per Oral Endoscopic Myotomy G-POEM as a less     invasive, effective alternative to surgery in patients presenting with gastroparesis.   "
42236|NCT02732808|"     This study is a prospective before & after clinical trial to investigate the efficacy of     double stimulations during both the follicular and luteal phases in patients with poor     ovarian response undergoing IVF and intracytoplasmic sperm injection (ICSI) cycles.      The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan     institute. The study is conducted according to the Declaration of Helsinki for medical     research. All participants provide informed consent after counseling for infertility     treatments and routine IVF/ICSI programs.      All the patients who diagnosed as poor ovarian responders (POR) based on the Bologna criteria     are eligible for participation in this study. In order to define the poor response in IVF, at     least two of the following three features must be present: (i) advanced maternal age or any     other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test     (ORT). Two episodes of POR after maximal stimulation are sufficient to define a patient as     poor responder in the absence of advanced maternal age or abnormal ORT.      Stage one of treatment protocol First stimulation performs by Clomiphene citrate (Ovumid®,     Iran Hormones Company) 25 mg/day with co-treatment of Letrozole (Letrofem®, Iran Hormones     Company) 2.5 mg/day are given from cycle day 3 onwards. Letrozole is only given for 4 days     and clomiphene citrate is continuously used before the trigger day. Patients start to inject     human menopausal gonadotrophin (HMG) (Menopur®, Ferring, Switzerland) 150 IU every other day     beginning on cycle day 6. When one or two dominant follicles (18 mm in diameter) observed,     the final stage of oocyte maturation will be induced with triptorelin 100 μg (Decapeptyl®;     Ferring GmbH, Germany) follows by ibuprofen 600 mg (Ibuprofen-Najo® , Coated Tablets, Najo     Company, Iran) is used on the day of oocyte maturation triggering and the day after. After     the first oocyte retrieval, human menopausal gonadotrophin and letrozole are administrated to     stimulate follicle development, and oocyte retrieval will be carried out a second time when     dominant follicles have matured. All highest-quality embryos (including grade 1 and grade 2,     eight-cell blastomere embryos) will be cryopreserved by vitrification method on the third day     after oocyte retrieval.      Stage two of treatment protocol:      Transvaginal ultrasound evaluation performs after oocyte retrieval to determine whether to     continue the second ovarian stimulation. The criterion for continued stimulation is the     presence of at least two antral follicles 2-8 mm in diameter. A total of 225 IU HMG     (Menopur®, Ferring, Switzerland) and letrozole 2.5 mg (Letrofem®, Iran Hormones Company) is     administered daily from the day of, or the day after, oocyte retrieval. The initial second     stage follicular monitoring is conducted 5-7 days later, and then for follow up every 2-4     days, by using a transvaginal ultrasound evaluation, to record the number of developing     follicles. Letrozole administration is discontinued when the dominant follicles reached     diameters of 12 mm, given that large follicles have redundant LH and FSH receptors, and good     response to exogenous hormone stimulations. Daily administration of medroxyprogesterone     acetate 10 mg (Progestrone®, 5mg bid; Aboureihan, Iran) is added beginning on stimulation day     12 for cases in which post-ovulation follicle size is smaller than 14 mm in diameter and     stimulation needed to continue for several more days. This performs to postpone menstruation     and avoid oocyte retrieval during menstruation, to prevent the risk of infection from the     procedure. When three dominant follicles reached diameters of 18 mm or one mature dominant     follicle exceeded 20 mm, the final stage of oocyte maturation is induced again with     triptorelin 100 μg (Decapeptyl®; Ferring GmbH, Germany) by injection. Again, ibuprofen 600 mg     (Ibuprofen-Najo® , Coated Tablets, Najo Company, Iran) is used on the day of oocyte     maturation triggering and the day after. Transvaginal ultrasound-guided oocyte retrieval was     conducted 32-36 h after GnRH agonist administration. All retrieved oocytes were treated same     as in the study stage one.   "
42259|NCT02732509|"     The purpose of this study is to determine how chronic inflammation influences skeletal muscle     protein metabolism and metabolic function in humans. The investigators will evaluate acute     responsiveness to a single bout of exercise in men and women who are either lean or     overweight/obese. The investigators will explore the relationship between circulating     inflammatory markers and anabolic, proteomic, and transcriptional responses to acute     exercise. The investigators will measure skeletal muscle protein synthesis in the     postabsorptive state and in response to a single bout of exercise.   "
42237|NCT02732795|"     Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is     estimated to comprise 530,000 procedures in children under 15 years of age. Historically, the     leading cause for these procedures was recurrent infections; however, more recently surgical     indications include sleep disordered breathing and obstructive sleep apnea (OSA).     Pre-operative polysomnography (PSG) is recommended for all children with suspected OSA prior     to undergoing AT, although it is unclear whether sleep disordered breathing characteristics     predict post-operative outcomes or complications.      Obesity has become an epidemic in our pediatric population. More recently, an increased     population of obese children are presenting for AT with upper airway obstruction with or     without tonsillar hypertrophy, which is similar to the adult etiology of OSA. Obesity is a     multisystem disease, causing fatty liver and cardiac disease, defects in glucose metabolism,     insulin resistance, leptin resistance, and creates a state of chronic inflammation. Markers     for inflammation, including TNF-α, CRP, leptin, IL-6 and IL-10, are abnormal in obese     patients and have also been linked to more severe OSA disease in children even after     controlling for BMI.      In pediatrics, medication dosing is based on an actual body-weight calculation, however,     recent reports suggest that this dosing method is over-dosing patients with obesity.     Therefore, increased respiratory complications after surgery may be related to inappropriate     intra-operative opioid dosing.      Specific Aim 1 (SA1): To compare analgesic-guided opioid dosing using actual body weight     (ABW) based dosing versus ideal body weight (IBW) dosing for adenotonsillectomy in children     with OSA (BMI >/=75%).      The investigators hypothesize that 1) weight-based opioid dosing compared to dosing based on     ideal body weight leads to increased respiratory complications defined by (a) upper airway     obstruction, (b) hypoventilation, and (c) oxygen desaturation without affecting pain scores     immediately after adenotonsillectomy. In addition, the investigators believe 2) that there     will be little statistically significant difference in pain scores between ABW and IBW for     these patients.      Specific Aim 2 (SA2): To determine whether biomarkers related to obesity, chronic     inflammation, and OSA predict post-operative respiratory compromise after AT. The     investigators hypothesize that inflammatory and obesity-related biomarkers are elevated in     overweight children with OSA, more so in obese children with OSA, compared to lean children     with OSA.   "
42238|NCT02732782|"     This is a prospective single blinded randomised controlled trial with a 12-week intervention     period and a half-year follow-up period. The main purpose is to determine the effects of     isometric exercise on mechanical, morphological and functional tendon properties versus     eccentric exercise in chronic Achilles tendinopathy.   "
42239|NCT02732769|"     the Mask fixation isn't a new solution for the immobilization of the patient's head and has     been used in current practice for long years.      This trial is attempting to compare these two technical possibilities of head fixation by     mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and     specifically for each step of the procedure. It will also evaluate other parameters such as     the effectiveness of these two strategies and tolerance.The expected benefit is an     improvement of the comfort for the patients.   "
42240|NCT02732756|"     Adolescents with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their     typically developing peers. Observational studies indicate that inadequate sleep is     correlated with impairment in adolescents with ADHD, but it remains unknown if sleep is     causally related to impairment. This study will use an experimental sleep restriction and     extension protocol to evaluate sleep as a contributor to clinically significant impairment     and possible target for intervention in adolescents with ADHD.   "
42241|NCT02732743|"     The primary objective is to assess the efficacy and safety of the Food Supplement     Physiomanna® Baby in pediatric patients with a history of functional constipation      The secondary objective of the trial is to evaluate the adherence to product's administration     in the enrolled children.   "
42242|NCT02732730|"     To assess the acceptance rate, adherence, acceptability, and continuation of oral     pre-exposure prophylaxis (PrEP) among young southern African women.   "
42243|NCT02732717|"     Recent years, women with infertility have become more and more and thus assisted reproductive     technology has been applied in a broad range. And the quantities of twin pregnancies are     larger and larger. However, complicated twin pregnancy subsequently increased including     selective intrauterine growth restriction (sIUGR), twin growth discordance, twin transfusion     syndrome (TTTS) and intrauterine fetal death (IUFD). The occurrence of complicated twin     pregnancy has been the leading cause of morbidity and mortality in twin and mother.     Meanwhile, twin pregnancy, especially monochorionic type has suffered from higher rate of     chromosomal anomalies and structural anomalies. Therefore, it is important that more     attention should be paid to the prediction, clinical evaluation and the occurrence of     chromosomal anomalies and structural anomalies in complicated twin pregnancy.      So far, prenatal ultrasound has been acknowledged as the best method for prenatal diagnosis     and evaluation in twin pregnancy. By means of the application of prenatal ultrasound, the     detection of fetal chromosome, and secondary correlation analysis, the investigators try to     build prenatal ultrasound monitoring system of twin pregnancy and provide evidences for the     choice of intervention and delivery time, in order to decrease the morbidity and mortality of     twin and improve perinatal short and long outcomes.      The goals of this study are as below: (1) primary goal: the prediction of complicated twin     pregnancy by using prenatal ultrasound; (2) primary goal: the clinical evaluation of     perinatal outcomes in twin pregnancy by using prenatal ultrasound; (3) secondary goal: the     analysis of the correlation between prenatal ultrasound and fetal anomalies.   "
42244|NCT02732704|"     The purpose of this research study is to collect information about a new treatment for severe     aortic regurgitation, which affects the aortic valve in the heart. Aortic regurgitation is a     condition where the heart's aortic valve does not close tightly and allows some blood to leak     back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and     shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve     replacement surgery.   "
42245|NCT02732691|"     The purpose of this research study is to collect information about a new treatment for severe     aortic stenosis, which affects the aortic valve in the heart. Aortic stenosis is a narrowing     of the aortic valve opening, which decreases blood flow from the heart and causes symptoms     such as chest pain, fainting and shortness of breath. The preferred treatment for severe     aortic stenosis is aortic valve replacement surgery.   "
42260|NCT02732496|"     The investigators will conduct a randomized placebo-controlled trial of a computerized     intervention targeting working memory in 30 children with comorbid     Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).   "
42271|NCT02732353|"     To measure the absorption kinetics and postprandial amino acid availability after ingestion     of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle     protein synthesis and the postprandial muscle protein synthetic response to minced beef and     hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein     synthetic response is measured and compared during the early postprandial period (0-3 hours)     after ingestion of the two meat products.   "
42246|NCT02732678|"     Adrenergic processes stimulated by epinephrine and norepinephrine drive to the development of     tumor growth and metastasis. Beta-adrenergic receptor (BAR) antagonists have shown efficacy     against melanoma, breast cancer and prostate cancer. The non-specific BAR inhibitor     propranolol has been used as the gold standard treatment in pediatric patients with benign     infantile hemangioma which express high levels of beta adrenergic receptors potentially     explaining their sensitively to propranolol. BAR have been shown to be expressed across a     diverse panel of vascular tumors, with the highest expression in malignant vascular tumors     including angiosarcoma. Several reports indicate positive results from beta-blockade in     patients with moderately threatening vascular tumors. It remains to be determined if more     malignant vascular tumor such as the angiosarcomas are susceptible to propranolol. Besides,     due to the lack of adequate therapies for angiosarcoma (doxorubicin or paclitaxel and finally     cyclophosphamide in third line) and to the poor prognosis of this rare and aggressive tumor,     there is a strong need for the development of treatments against this tumor type. Recently     using a panel of angiosarcoma cell lines. demonstrate that beta-adrenergic inhibition blocks     cell proliferation and induces apoptosis in a dose dependent manner. Moreover, using in vivo     tumor models they demonstrate that propanolol shows remarkable efficacy in reducing the     growth of angiosarcoma tumors. Based on these proofs of mechanisms in vitro and in vivo and     due to the well established safety propranolol in humans, investigators propose to determine     among a wide range of propranolol dose (80 mg/d ; 120 mg/d and 160 mg/d) the optimal one     based on bivariate efficacy-toxicity outcome in patients with angiosarcoma treated by     cyclophosphamide. Because these two drugs have different pharmacological mechanisms, the aim     is to determine the optimal dose of propranolol having the best systemic cardiovascular     tolerability and the best potential antiangiogenic effect in addition with cyclophosphamide.   "
42247|NCT02732665|"     In this study, glycosaminoglycan (GAG) profiling in subjects first diagnosed with metastatic     ccRCC is hypothesized to be useful in monitoring drug response and predict the outcome of a     CT scan. To this end, regularly measured plasmatic and urinary GAGs in prospectively enrolled     subjects will be correlated to drug response as evaluated by the designated clinician based     on CT scans. A positive correlation indicates that this test can successfully detect patients     that are not responding to treatment before the scheduled follow-up in which CT scans are     performed. Data on the extent of metastasis (number of metastatic sites) will be collected to     assess whether the biomarker level correlates accordingly.   "
42248|NCT02732652|"     In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion     of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early     actionable clinical decisions are desirable. For example to screen population at risk or to     distinguish benign masses from RCC before patient is referred to surgery. To this end, the     plasmatic and urinary GAGs will be measured in prospectively enrolled subjects and the     resulting scores correlated to the post-surgical definitive diagnosis and eventual RCC size.     A positive significant correlation is suggestive that GAG profiling can be used to guide     clinical intervention in a subject at risk or referred to nephrectomy because of suspicion of     RCC. The biomarker in patients with high risk RCC will be monitored to observe its     correlation with disease progression. Also, the biological significance of this positive     correlation will be evaluated using gene expression profiling. This data may also be used to     improve further the diagnostic accuracy of the proposed biomarker.   "
42249|NCT02732639|"     This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon     (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD).     Treatment was followed by 24 weeks of treatment-free follow-up.   "
42250|NCT02732626|"     This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation     lines in addition to pulmonary vein isolation may improve the outcome in patients with     persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.   "
42251|NCT02732613|"     The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's     recommendation based on the patient's ideal weight. But sometimes the patient is tall and     slim, the actual weight is much less than the ideal weight. This phenomenon might affect the     success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal     Mask Airway size based on ideal weight could improve the success rate of insertion;     therefore, this study was designed to prove whether this conclusion also applies to the tall     and thin patients.   "
42252|NCT02732600|"     In August 2014, the White House issued an Executive Action mandating that 25 VA medical     centers place Peer Specialists (Veterans recovered from mental illness who are trained to     support other Veterans with mental illness) on Primary Care Teams. Research shows that the     success of adding new staff to existing teams can be improved by outside aid and     facilitation. This quality improvement project will evaluate whether providing expanded     support to half of the Primary Care Teams will lead to better outcomes when compared with     teams that do not get extra support.   "
42253|NCT02732587|"     The purpose of this alcohol-interaction pilot study is to provide information on the effect     of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses,     including stimulation, sedation, intoxication, body sway and physiological responses. The     investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol     related responses. This is a within subjects open label study in which the investigators plan     to run 8 subjects to obtain 5 completers.   "
42350|NCT02731313|"     The primary objective is to evaluate the concordance between human epidermal growth factor     receptor 2 (HER2) status determined by the participating laboratory and by the centralized     laboratory. HER2 status of samples was tested by the participating laboratories     (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH] methods)     and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH).     Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.   "
42254|NCT02732574|"     Respiratory dysfunction following cardiac surgery is well documented and due in part to the     location of the incision and nature of the surgery. Post-operative pulmonary complications     (PPCs) remain a significant problem following cardiac surgery, sometimes causing prolonged     length of stay in hospital as well as increased morbidity and mortality; with the greater     risk to older adults and individuals with obstructive lung disease. Positive expiratory     pressure (PEP) therapy is thought to increase lung volumes and facilitate secretion     clearance. The purpose of this study is to investigate whether the addition of oscillating     PEP therapy to standard postoperative treatment is more effective in decreasing the incidence     of PPCs and increasing functional capacity at time of discharge in 'high risk' patients     undergoing elective cardiac surgery.   "
42255|NCT02732561|"     This is a trial of the use of cranial electrostimulating therapy for depression and anxiety     among homeless adults.   "
42256|NCT02732548|"     This study is being conducted to collect data on the performance of Miromatrix Wound Matrix     (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.   "
42257|NCT02732535|"     This study will determine the role of the NK cells before and after bariatric surgery. The     investigators selected patients with NAFLD.      A Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.   "
42258|NCT02732522|"     To analyze whether there is a statistically significant difference in the modifications     present in the uterine cervix 6 hours after administration of misoprostol 50 µg through     vaginal versus sublingual routes.   "
42261|NCT02732483|"     Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases     mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed,     controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate     is still high, even after successful hemostasis with APC or electrical coagulation.     Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes     than those who are not. So excellent bleeding control in gastric cancer is most important in     GI hemorrhage of gastric cancer.      Recently developed hemostatic powder [Endo-Clot(TM)] is easy to use and have proven its     usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try     to find out feasibility & safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.   "
42262|NCT02732470|"     Systemic Lupus Erythematosus (SLE) is chronic and systemic autoimmune disease that mainly     affecting women and leading to organ damages especially skin, joints, kidneys, central     nervous system and heart. In SLE, immune system dysfunction leads to autoantibodies,     autoreactive T cells and pro-inflammatory cytokines production. These elements will initiate     and maintain organ damages. Patients with SLE have disease flares followed by period of     remission. Flares can occur because of stress, infections, surgery, pregnancy or ultraviolet     exposition. Furthermore the chronic nature of SLE is an important factor of depression in     these patients.      Qi Gong is an ancient Chinese practice based on relaxation movements, posture and breathing     in order to harmonize the body and mind. This practice improves the general state by reducing     fatigue and improving sleep. The beneficial effect of Qi Gong in medicine has been studied in     several diseases including cancer, diabetes, arterial hypertension and fibromyalgia. Qi Gong     seems interesting in depressed patients but also to reduce stress in healthy subjects.      The aim of this study is to evaluate the effects of Qi Gong on quality if life in patients     with SLE. Patients will have two lessons of 60 minutes per week for three months and a     collective lesson of 90 minutes per week for three months. The teacher of Qi-Gong will     evaluate adherence to the practice of Qi Gong every week. Clinical and biological data will     be collected at baseline and at 2th, 4th, 6th, 9th and 12th month. Different evaluation     scores and neurotrophin levels will be collected at baseline and at 6th month.   "
42264|NCT02732444|"     Chronic Obstructive Pulmonary Disease (COPD) patients in Long-Term Home Oxygen Therapy (LTOT)     have a reduction in airflow that is not totally reversible. This obstruction may be     associated with an abnormal inflammatory response of the lungs as a result of inhalation of     toxic particles, particularly to cigarette smoke. Furthermore, COPD patients also present     limited symptoms to physical exercise, significant extrapulmonary effects, including weight     loss, nutritional abnormalities and skeletal muscle dysfunction. Hyperinflation has been     identified as a major cause of dyspnea and is currently believed to be already present in the     early stages of the disease, causing limitations in physical capacity. The progressive     exertional dyspnea is most associated with impairment to activities of daily living,     decreased quality of life and worse prognosis. Traditionally, the severity of COPD is defined     by the degree of obstruction, as measured by forced expiratory volume in one second (FEV1)     after bronchodilator use (post-BD) and can be classified as mild, moderate, moderately severe     and very severe disease. In the group of patients with Advanced Pulmonary Disease (APD),     those with partial pressure values of oxygen (PaO2) lower or equal to 55mmHg, or arterial     oxygen saturation (SaO2) lower or equal to 88% in ambient air; or those with PaO2 values     between 55-60 or SaO2 lower than 90%, with evidence of pulmonary hypertension or polycythemia     require LTOT, over 15 hours / day, with evidence of increased survival. The aim of this study     is to evaluate the erythrocyte membranes stability in COPD and APD patients in LTOT compared     to healthy subjects. It is a cross-sectional, observational study with evaluation of     erythrocyte membranes stability among the groups as well as lung function, physical testing,     laboratory analysis, oxidative stress and quality of life questionnaires. As red blood cells     are the cells responsible for the gas exchange in the lungs and peripheral tissues, and since     the patients with COPD and APD have gas exchange impairment compared to the healthy group, it     is expected to find a difference in erythrocyte membranes stability and levels of oxidative     stress among the groups.   "
42265|NCT02732431|"     Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric     practice, there is no way to determine the children with an increased risk. The aim of the     study is to determine the reliability of four questionnaires used in pediatric patients in     screening of OSA in Down syndrome children.      Prospective study where patients are evaluated on airway diseases and aeroallergens     sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by     completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an     overnight polysomnography (PSG), in University Hospital in Nice.   "
42266|NCT02732418|"     This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and     compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL     or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the     abdomen, in women of reproductive age with confirmed ovulatory baseline cycle   "
42267|NCT02732405|"     To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients     with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non     responders to PR.   "
42400|NCT02730663|"     The purpose of this study is to evaluate the safety and effectiveness of endoscopic     ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of     pancreatic pseudocyst.   "
42268|NCT02732392|"     The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a     prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is     a very important element in the coverage (care). He allows to determine the local extension     of the disease and the type(chap) of therapeutics to implement(operate) after the surgery.     The standard cleaning out at present recommended by the European company (society) of urology     at the patients at intermediate or high risk of second offense (recurrence) after local     treatment(processing), has to concern the obturating pit, the internal and external iliac     territories. However this type(chap) of cleaning out does not seem to solve all the problems     of locoregional stratification. Indeed, several studies concerning the radio-controlled     cleaning out highlighted that 10 in 30% of ganglions.   "
42269|NCT02732379|"     The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or     ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in     patients with postoperative nausea and vomiting.   "
42270|NCT02732366|"     The purpose of this study is to test the feasibility and preliminary efficacy of a     group-based fall prevention program for older adults.   "
42272|NCT02732340|"     The purpose of this study is to compare triple-branched stent placement with hemi-arch     replacement in the treatment of acute DeBakey I aortic dissection . The investigators design     a prospective, multi-center, randomized, open-label, parallel-group, optimal effect     comparative clinical trial.   "
42274|NCT02732314|"     This is a 13 week randomized, double blind, parallel group, in home use study among     approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic     dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity,     age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12     week treatment phase. During the washout phase, subjects will be provided with a bar soap for     bathing and showering and must refrain from using any other products on their body (excluding     the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the     treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment     phase, the subjects will be required to use only the provided bar soap for bathing and     showering and will apply their test product twice per day, once in the morning and once in     the evening. No additional creams, moisturizers, lotions or cleansers other than those     provided will be permitted for the duration of the study. Normal facial or hair care products     are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff     shampoo, acne products, etc).      SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit,     subjects will have an active inflammatory lesion site and adjacent non-lesion,     non-inflammatory site identified and marked for all instrumental and biopsy evaluations at     Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and     self-assessments will be performed throughout the study. Tolerability will be evaluated by     incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site     reactions/infections, and lab evaluations throughout the study. There will be additional     consumption and compliance checks as well as dermatologic evaluations to ensure the subject's     condition does not become extensively worse at each visit. A subset of subjects will have 2mm     punch biopsies collected from the designated lesion and non-lesion sites at 3 time points     throughout the study. The subset of subjects will be determined by subject willingness to     participate in the biopsy portion as well as dermatologic evaluation and determination of     biopsy candidacy.   "
42275|NCT02732301|"     The purpose of this study is to investigate the frequency and grade of gastrointestinal     dysfunction in patients after thoracic cardiovascular surgery, and to search for biomarkers     of gastrointestinal dysfunction. All adult patients undergoing elective cardiac surgery     requiring cardiopulmonary bypass at Örebro University Hospital, Örebro, Sweden, are asked for     participation in this study. All participating patients sign informed consent at the     inclusion. The first three postoperative days the function of the gastrointestinal tract is     scored according to a rating scale (grade 0-4), along with other clinical parameters. Plasma     blood samples are collected from each patient preoperatively and the first three     postoperative days. The plasma samples are stored in a biobank for later determination of     plasma proteins. In the analysis, the patients are divided according to the gastrointestinal     rating scale and the plasma protein expression, gastrointestinal complications and all-cause     mortality are compared between the groups.   "
42276|NCT02732288|"     Patients with severe brain injuries often have slow accumulating recoveries of function. In     ongoing studies, we have discovered that elements of electrical activity during sleep may     correlate with the level of behavioral recovery observed in patients. It is unknown whether     such changes are causally linked to behavioral recovery. Sleep processes are, however,     associated with several critical processes supporting the cellular integrity of neurons and     neuronal mechanisms associated with learning and synaptic modifications. These known     associations suggest the possibility that targeting the normalization of brain electrical     activity during sleep may aid the recovery process. A well-studied mechanism organizing the     pattern of electrical activity that characterizes sleep is the body's release of the     substance melatonin. Melatonin is produced in the brain and released at a precise time during     the day (normally around 8-10PM) to signal the brain to initiate aspects of the sleep process     each day. Ongoing research by other scientists has demonstrated that providing a small dose     of melatonin can improve the regular pattern of sleep and help aid sleep induction. Melatonin     use has been shown to be effective in the treatment of time change effects on sleep (jet     lag) and mood disturbances associated with changes in daily light cues such as seasonal     affective disorder. We propose to study the effects of melatonin administration in patients     with severe structural brain injuries and disorders of consciousness. We will measure the     patient's own timing of release of melatonin and provide a dose of melatonin at night to test     the effects on the electrical activity of sleep over a three month period. In addition to     brain electrical activity we will record sleep behavioral data and physical activity using     activity monitors worn by the patients. Patient subjects in this study will be studied twice     during the three month period in three day inpatient visits where they will undergo video     monitoring and sampling of brain electrical activity using pasted electrodes (EEG), hourly     saliva sampling for one day, and participation in behavioral testing.   "
42277|NCT02732275|"     This will be a First-in-Human, Phase 1, multi-center, non-randomized, open label study of     DS-3201b, Histone-lysine N-methyltransferase EZH1/2 dual inhibitor to assess its safety and     tolerability, identify a maximum tolerated dose (MTD)/ tentative recommended phase 2 dose     (RP2D), and assess its pharmacokinetic/dynamic properties in Japanese subjects with     Non-Hodgkin's Lymphoma.   "
42278|NCT02732262|"     Postoperative pain control is required after major abdominal surgery, including laparoscopic     colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control     mainly in Europe.      The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain     control after laparoscopic colorectal surgery in Korean.   "
42279|NCT02732249|"     Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with     either amoxicillin or metronidazole are no longer recommended as empirical ﬁrst-line therapy     to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown     whether the addition of bismuth overcome antibiotic resistance. This study is designed to     evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H.     pylori first-line eradication.   "
42280|NCT02732236|"     Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity,     prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL     patients' cohort for several observation study   "
43295|NCT02718937|"     The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585     compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b     virus.   "
42281|NCT02732223|"     Atherosclerosis, one major cause of morbidity and mortality worldwide, is a complex and     multifactorial disease triggered especially due to high level of plasma lipids and that     involves three mainly conditions: chronic inflammation, dyslipidemia and oxidative stress.     Taking into account the high costs of disease management, eminent suboptimal response and low     compliance to drug therapies, the combined use of natural bioactive compound able to reduce     atherosclerosis risk could provide an additional protection. In this study, the effects of     three bioactive components, namely omega-3 fatty acids, plants sterols and polyphenols     present in green tea, will be evaluated over atherosclerosis biomarkers in individuals with     dyslipidemia controlled by drugs. It will be carried out a randomized, double-blind,     placebo-controlled, crossover clinical study, with participation of 70 subjects. At each     intervention period, study participants will receive a packaged for the functional or placebo     treatment. Functional treatment packaged will be composed by omega 3 softgels (fish oil), a     chocolate containing plant sterols and green tea. Placebo treatment will be composed by corn     oil softgels, regular chocolate, and anise tea. Subjects will be advised to consume the     softgels and chocolate twice a day after main meals and to drink two cups of tea per day.     After evaluation of inflammation, dyslipidemia and oxidative stress biomarkers, subjects with     the greatest response to the functional treatment will be selected for additional 6 weeks of     functional intervention associated to a reduction of the hypolipidaemic drugs intake, which     will be prescribed individually after evaluation of the responsible physician.   "
42282|NCT02732210|"     The objective of this study was to describe persistence with Prolia® 60 mg administered     subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.   "
42283|NCT02732197|"     Background: This study was designed to investigate the effect of sedation on the occurrence     of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1     Cesarean section (C/S) under spinal anesthesia.      Methods: After institutional ethics committee approval, prospectively collected data of 1824     parturients undergoing C/S were reviewed. Parturients with high preoperative anxiety scores     (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with     thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included in     the analysis. Hemodynamic parameters were documented and maximum systolic arterial pressure     (SAP) reductions from the baseline after spinal anesthesia were calculated. Incidences of     hypotension (SAP≥30% decrease from baseline or <100 mmHg) and bradycardia (HR<55 beats/min),     and related-ephedrine and -atropine requirements were noted. Our primary endpoint was to     compare the maximum SAP reductions from the baseline values in Groups S and NS. Secondary     endpoints were incidences of hypotension and bradycardia, required ephedrine and atropine     doses, newborn Apgar scores at 1st and 5th min.   "
42284|NCT02732184|"     This is the first study of the safety of increasing dose levels of AEB1102 in patients with     Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will     also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid     levels and the antitumor effects of AEB1102.   "
42285|NCT02732171|"     This is a single center, prospective cross-sectional study of women who have completed     therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for     relapse.      Patients will undergo screening bone marrow aspirate to test for presence of disseminated     tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment     into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).   "
42286|NCT02732158|"     This prospective, nonrandomized, feasibility study will compare laboratory measures at the     beginning and end of the study period in adults consuming a nutritional study product.   "
42287|NCT02732145|"     To determine the sensitivity and specificity of Three Rings Vulvoscopy for detection of     vulvar dermatosis using histopathology as the reference standard.   "
42288|NCT02732132|"     The primary aim of this study was to investigate the efficiency and safety of midazolam plus     ketamine versus fentanyl plus propofol administered to children undergoing UGE and to     determine the most appropriate sedation protocol.   "
42289|NCT02732119|"     The purpose of this study is determine if the triplet combination of ribociclib, everolimus     and exemastane is effective in the treatment of locally advanced/metastatic breast cancer     following treatment with a CDK 4/6 inhibitor   "
42290|NCT02732106|"     Human adipose tissue is now recognized as an acceptable, highly abundant source of     adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of     cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and     vessel-associated cells. Autologous adult regenerative cells are thought to promote healing     of scarred or injured tissue. While the investigators are learning more about the exact     mechanisms every day, it is believed that this heterogeneous population of cells influences     the local environment via cell-to-cell signaling, immune modulation, and differentiation into     other cell types. The use of ADRCs in the treatment of many different medical conditions     (including cardiovascular disease, soft tissue defects, wound healing, and many more) is     being evaluated in numerous clinical and preclinical studies around the world. While there is     a considerable amount of information regarding the cellular composition of ADRCs isolated     from healthy donors, basically there is no much data regarding the ADRC composition from     cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia     patients, that would otherwise be thrown away in waste, will be provided to researchers who     will study these cells with the objective to characterize ADRCs derived from patients with a     heart disease and to compare if a heart disease state does impact ADRC cell composition.   "
42291|NCT02732093|"     In this study investigators will evaluate the effect of stellate ganglion block on stress     response of intubation in comparison to traditional antistress measures in adult patients   "
42305|NCT02731898|"     A prospective, international and multicenter, non interventional single-cohort study, which     will enroll consecutive adult patients who have received mechanical ventilation (invasive and     noninvasive ventilation) for at least 12 hours during a 1-month period, and will follow each     patient for the duration of mechanical ventilation, up to 28 days. The main objectives will     be to analyze the mortality and clinical outcomes in ventilated patients and secondly, to     evaluate the practices of liberation from mechanical ventilation, the failure of non invasive     ventilation in the ICU, and to analyze the clinical outcomes in specific populations of     critically ill patients with the need of mechanical ventilation.   "
42292|NCT02732080|"     After reopening of the infarct related artery by primary percutaneous coronary interventions     (PPCI), microvascular damage at the related myocardial territory is not terminated     immediately. This ongoing nature of microvascular damage leading to myocardial malperfusion     is related to final infarct size. However, time course of the microvascular impairment     /obstruction after PPCI in patients presented with ST-elevating acute myocardial infarction     (STEMI) is not known. Routine primary percutaneous coronary interventions (PPCI) for     ST-elevation acute myocardial infarction (STEMI) includes balloon angioplasty (or     thrombectomy) followed immediately by stent implantation. However, stent implantation     performed in this thrombotic setting may lead to a further microvascular damage by causing     more distal embolisation and by inducing distal microvascular spasm by stretching the     coronary vessel wall. Furthermore, sudden exposure of distal microcirculation to a high     distal intracoronary pressure achieved by immediate stent implantation may exaggerate     myocardial oedema which contributes microvascular damage substantially by external     compression. However, results of studies investigating the efficacy of delayed stenting     (24-48 hours later) in patients in whom TIMI -3 flow was achieved after balloon angioplasty     were inconsistent.      In this study, STEMI patients undergoing PPCI, in whom epicardial reperfusion was achieved     (TIMI-3 flow) by wire crossing or by balloon angioplasty or aspiration thrombectomy, will be     randomised to immediate and delayed stenting groups. Delayed stenting will be performed at     the time when coronary auto regulation was recovered which is going to be determined based on     the continuous intracoronary hemodynamic monitoring after reperfusion.   "
42293|NCT02732067|"     Death rate in anesthesia is one of the most valuable methods to assess the safety of     anesthesia practice among different types of patients.      In this study, the investigators will follow the death among patients who underwent surgery     under anesthesia whether regional or general over the next two years from 2016 to 2018.   "
42294|NCT02732054|"     This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in     HIV-infected adults with low CD4 cell count in northern Thailand.   "
42310|NCT02731833|"     This single centre, comparative design study will be used to investigate the efficacy of an     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity     (DH) after short term use compared with a standard fluoride dentifrice   "
42297|NCT02732002|"     Work-related injuries of the shoulder complex represent a challenge for clinicians due to the     large variety of clinical entities involved and the broad anatomic structures that are     potentially affected. Furthermore, commonly performed orthopedic tests have demonstrated     limited accuracy for the actual diagnosis of the injury. Although considerable research has     been performed to standardize a model for shoulder injury management, a comprehensive     approach integrating both a clinical and functional based status of the pathology and adapted     rehabilitation prescription remains lacking.      The present study protocol aims to complement previously published shoulder injury management     algorithms. Potentially, the multi-component, individualized and progressive multi-etiologic     shoulder injury management model for rehabilitation could become a new effective strategy for     reducing the time required to regain functional capacity and symptom recovery among patients     with work-related shoulder injuries.   "
42298|NCT02731989|"     In addition to the manual preoperative examination, the undescended testicle will be measured     ultrasonographically. The compared data will help us to evaluate the routine need for     preoperative ultrasonographic evaluation of the undescended testicle.   "
42299|NCT02731976|"     Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD)     for four weeks were studied. Per participant, nine stool samples were collected: one at     baseline, four during the GFD period, and four when they returned to their habitual diet.     Microbiome profiles were determined using 16S rRNA sequencing and the samples were next     processed for taxonomic and imputed functional composition. Additionally, participants kept a     3-day food diary and six gut health-related biomarkers were measured.   "
42300|NCT02731963|"     Colorectal surgery is highly associated with septic complications, therefore, multiple     approaches have been used to reduce this complications, one of the most used is mechanical     bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation     might not be necessary.   "
42301|NCT02731950|"     Effective pain relief after cardiac surgery has assumed importance with the introduction of     fast track discharge protocols that requires early weaning from mechanical ventilation.     Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of     atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound     has shown to improve early postoperative pain in various surgical procedures.      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in     animal and human models of pain.   "
42302|NCT02731937|"     The main purpose of this study is to collect clinical raw scan data and Scanner user feedback     using dual energy CT (computed tomography) scan modes on the investigational CT scanner.     Additionally, image quality using prototype reconstruction algorithms that are in development     will be evaluated and compared to standard-of-care images acquired with regulatory cleared     diagnostic CT scanners for feasibility assessment and engineering development. Compared to     standard clinical single energy (kilovolt,kV) scanning, dual energy (kV) scanning s provides     more information about the material composition of the scanned patient and may allow for     improved tissue, tumor characterization, and improved image quality.   "
42303|NCT02731924|"     The primary purpose of this study is to determine the accuracy of ultrasound (US) in     diagnosing appendicitis in emergency department (ED) patients, as compared to the criterion     standards of computed tomography, operative reports, or discharge diagnosis.      The secondary purposes of the study include evaluation of the effect of ultrasound for     appendicitis on the patient length of stay in the emergency department, the diagnostic     utility of specific ultrasound findings in the diagnosis of appendicitis, the role of body     mass index (BMI) in the utility of ultrasound for appendicitis and relation of ultrasound     findings to the Alvarado score. The study will also examine the inter-rater agreement between     point-of- care sonographers' interpretation and blinded reviewers' interpretation of the     ultrasound images.   "
42304|NCT02731911|"     This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in     clinical practice.   "
42306|NCT02731885|"     The goal of this study is to determine the impact of the food on the absorption of the     ABX464.   "
42307|NCT02731872|"     The purpose of our study is to establish whether domiciliary use of the Airvo warm passover     humidifier can reduce the number of exacerbations in patients with respiratory insufficiency.     Participants must have a diagnosis of chronic obstructive pulmonary disease (COPD) and be in     long term oxygen therapy (LTOT). The following questions will be investigated:      Do outpatients receiving long term oxygen therapy benefit if this is delivered through an     Airvo humidification system. The proposed benefits under investigation are:        1. a reduction in the number of exacerbations and thus hospital admissions?        2. an increase in quality of life (QOL)?        3. an improved lung function and thus increased physical activity?   "
42308|NCT02731859|"     The purpose of this study ist to determine long-term safety and efficacy in weight reduction     and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal     bypass-sleeve EndoBarrier® in a national registry.   "
42309|NCT02731846|"     The primary purpose of this study is to assess the equivalence of closed triple therapy     Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) to open triple therapy (FF/VI +     UMEC), with a comparison of both triple therapies to dual therapy (FF/VI) on lung function.      This is a phase III, 4-week, randomized, double-blind, parallel group, multicenter study     comparing FF/UMEC/VI (100 micrograms [mcg]/62.5 mcg/25 mcg) delivered via a single ELLIPTA®     inhaler ('closed' triple) + matching placebo ELLIPTA inhaler, FF/VI + UMEC delivered via two     ELLIPTA inhalers ('open' triple) and FF/VI via a single ELLIPTA inhaler + matching placebo     ELLIPTA inhaler, all once daily. The total duration of subject participation will be     approximately 7 weeks, consisting of a 2-week run-in period, 4-week treatment period and a     1-week follow-up period.      ELLIPTA is a registered trade mark of the GSK group of companies.   "
42311|NCT02731820|"     The purpose of this study is to investigate whether the use of alkali compounds, i.e.     potassium citrate (K3C6H5O7, hereinafter KCitr) is effective in preventing the progression of     osteopenia.      A randomized clinical trial (RCT, placebo-controlled, double-blind) has been planned to     evaluate the effect of the daily administration of KCitr (3 g/die, K 30 mEq).      The efficacy will be evaluated by comparing the circulating levels of bone turnover markers     at the baseline and after the treatment (3, 6 months).   "
42312|NCT02731807|"     This study is a pilot research study in humans to determine the steady state pharmacokinetic     profile of TA-65 after oral dose of formulated and unformulated forms. There will be eight     (8) subjects of healthy men and women (non-child bearing). TA-65 is supposed to supplement     the diet to increase general health through telomerase activation.The active ingredient in     TA-65 activates an enzyme called telomerase. However, the active ingredient has poor oral     bioavailability in humans. This study is created to enhance the bioavailability in telomerase     with different formulations; powder and capsule form.   "
42313|NCT02731794|"     The investigators designed the randomized prospective study to evaluate the differences of     inflammatory response and clinical outcome after on-pump beating coronary artery bypass     grafting undergoing left ventricular assist versus biventricular assist in patients with     severe left ventricle dysfunction.   "
42314|NCT02731781|"     Traumatic brain injury (TBI) is the major cause of disability and death among the younger     population. In the Pediatric population Head trauma may be responsible for primary and     secondary brain damage. Primary brain injury results from a direct mechanical damage at the     time of injury, whereas secondary injury is caused by further cellular damage that develops     hours or days post injury. Intracranial Injury in Infants (III) may be hard to diagnose in     the abcence of neurological deficit or early deterioration. On the other hand, symptoms such     as vomiting and restlessness may be present even in the case of minor head injury, and     unnesessary scaning (CT) may be performed in many centers just because clinical judgment is     problematic in this particular age. Some intracranial injuries may be imminent, such as     evolving Epidural hematoma (EDH) in infants, and early diagnosis may be lifesaving and     leading to excellent outcome. In adults, GCS has been accepted as the most usuful tool for     emergency evaluation of head injured patients. In children, several scores were introduced,     including the Children's Coma Score (CCS), however they have been found problematic to use in     the very young population, since accurate evaluation of communication in CCS is hard, and     there is insufficient relevant parameters uncorporated into the score that may have     significant importance in this particular age group. In TINS (Trauma Infant Neurological     Score) we characterized the clinical parameters and the mechanism of trauma in a simplified     method. As previously published, this score has been used by us and by other groups, in     retrospective studies. Still, in the lack of prospective studies using TINS, there are no     optimal guidelines to perform computed tomography (CT) in this unique population, and TINS     has not prospectively been challenged as a predictor tool for outcome. In this prospective     study we will approach these issues.   "
42315|NCT02731768|"     The purpose of this study is to evaluate whether a social support-enhanced, technology-based,     behavioral weight control intervention can improve weight loss over existing best practices.   "
42316|NCT02731755|"     A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole     grains contain a wide range dietary components including potentially vasoactive phenolic     acids. In this proposed human trial, the investigators aim to establish whether consumption     of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h     post-intake) in markers of cardiovascular disease risk relative to an energy matched control     intervention in healthy men with high-normal to mildly elevated blood pressure.   "
42318|NCT02731729|"     The purpose of this research study is to learn whether patients whose disease grows after     being treated with nivolumab or pembrolizumab respond to ipilimumab (Yervoy®) alone or in     combination with nivolumab (Opdivo®).   "
42319|NCT02731716|"     To design an innovative payment system that improves upon fee-for-service (FFS), incorporates     behavioral economic principles, and improves work satisfaction among primary care physicians     (PCPs) while improving quality and reducing health spending at the state level. Second, to     test the incremental effectiveness of two additional interventions: (1) shared financial     incentives between physicians and poorly controlled diabetes and (2) social comparisons     ranking physicians on quality metric performance and total cost of care.   "
42320|NCT02731703|"     This study will identify and enroll patients already scheduled to receive guided maxillary     implant placement with palateless overdenture. Standard clinical practice will be followed     for this multi-stage process. The study purpose is to evaluate the degree of satisfaction     during the standard progression in order to determine at which post edentulous stage patients     achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).   "
42321|NCT02731690|"     This is an open-label multi center study to evaluate the safety of Aceneuramic Acid Extended     Release (Ace-ER) Tablets for patients with GNE Myopathy.The primary objective of this Phase 2     study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM subjects with severe     ambulatory impairment. The study will also assess efficacy to ensure that the full spectrum     of patients with GNEM are evaluated.   "
42322|NCT02731677|"     Sleep disorders correspond to a non-motor symptom present in DP, being represented by daytime     sleepiness and maintenance insomnia. This study aims to evaluate the effects of acupuncture     on sleep disorders in patients with PD assisted by Pró-Parkinson Program at University     Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the Ethics     Committee for Research with Human. It was included patients with diagnosed with Idiopathic     Parkinson's disease, Mini Mental State Examination (MMEE) according to education, stages 1, 2     and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's disease (PDSS), a     self-administered scale designed to assess nighttime sleep problems, sleep disorders and     excessive daytime sleep. Twenty-two subjects were allocated in two groups: experimental and     control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11     - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental group. The control group     no suffered intervention. The paired analyzes were performed using the Wilcoxon test and the     independent analyzes using the Mann-Whitney test.   "
42324|NCT02731651|"     Laparoscopic surgery has played a pivotal role in all surgical fields in modern medicine. It     has some well known advantages over open surgery. For this reason laparoscopic surgery is     know the first choice for many surgical procedures, even in gynecology. On the other hand,     despite the advantages of laparoscopy carbon dioxide (CO2) pneumoperitoneum is not free from     side effects. Experimental studies and limited clinical studies showed that pneumoperitoneum     leads to a decrease in the blood flow to intra-abdominal organs during laparoscopic surgery.     This is also known as ischemia, leads to the production of free O2 radicals. The desufflation     of the abdominal cavity at the end of the procedure reduces the increased abdominal pressure     and increase the perfusion of intra-abdominal organs. However this will not stop the     production of free radicals. This reperfusion period even exaggerate the release of free     radicals. This phenomenon is called as ischemia/reperfusion (I/R) model that leads to release     of various free radicals, which are the most important mediators of oxidative tissue injury     and consequential organ dysfunction. Recently both oxidative tissue injury and consequential     dysfunction have been shown in ovarian tissue in experimental animal studies. But the data     related to human ovary is still scarce. Thus the aim of the study is to evaluate the effect     of I/R injury related to CO2 pneumoperitoneum on human ovary.   "
42325|NCT02731638|"     Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical     trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers.     There is currently little evidence to guide the treatment of fungal keratitis beyond topical     anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used     as well. This study will provide evidence to guide the treatment of fungal keratitis in the     future. The purpose of this study is to determine differences in microbiological cure for     3-day repeat cultures between different antifungal treatments. For this study, there will be     1:1 randomization to one of these two treatment groups: 1) topical natamycin plus     intrastromal voriconazole injection or 2) topical natamycin alone.   "
42326|NCT02731625|"     The purpose of this study is to investigate the performance benefits of supplementing Army     standard Physical Readiness Training (PRT) with a defined kettlebell (KB) deadlift and swing     training program as compared to standalone PRT. Power and performance will be measured on     horizontal (broad) and vertical jumps, 40 yard sprint, 60 yard shuttle, and the Army Physical     Fitness Test (APFT). It is hypothesized that the unique force distributions of kettlebell     training will promote improved power, particularly across the horizontal plane, when compared     to standalone Army PRT. Findings will potentially provide insight as to how Army units can     effectively utilize kettlebells to further diversify their training programs.   "
42327|NCT02731612|"     This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to     assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression)     who are in remission from an episode. Participants who show cognitive impairment at the     screening visit will be enrolled into the study and randomized at the baseline visit to     receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.   "
42328|NCT02731599|"     The first aim of this study was to evaluate the effect of a gait training using treadmill     with visual and auditory cues in patients in stages IV Hoehn & Yahr (H&Y). The second aim was     to compare the obtained data of these patients in advanced stages with those in mild to     moderate stages.   "
42329|NCT02731586|"     As Regenerative Medicine is the next level in medicinal sciences, the use of mesenchymal     cells have become prevalent, Similarly now stem cells are being used in dental research as     well in various clinical applications.This study aims to evaluate the overall effect of     osseointegration by use of Allogenic Mesenchymal Stem cells while placing dental     implants.Healthy subjects will be chosen and dental implants placed bilaterally one with     standard surgical protocol and other with the use of Allogenic Mesenchymal Stem cells.The     implant stability is checked using Resonance frequency analysis(RFA).The RFA values are     statistically evaluated at various intervals and observations will be analysed on both test     and control side.   "
42330|NCT02731573|"     This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months     post operation as well as the safety over a period of 6 months, by preventing sternal     infection post cardiac surgery in patients above the age of 18, including high risk patients     for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized     controlled study.   "
42331|NCT02731560|"     A study to determine the efficacy and safety of rituximab in Pakistani patients with     rheumatoid arthritis (RA) who have been inadequately controlled with standard disease     modifying anti rheumatic drugs (DMARDs).   "
42332|NCT02731547|"     A two armed randomized trial is evaluating the effect of the medical-student-delivered     school-based intervention Education Against Tobacco on the smoking behavior of adolescents in     7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the     change in smoking prevalence between the two groups.   "
42333|NCT02731534|"     The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated     Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with     Iron-deficiency Anemia (IDA)   "
42334|NCT02731521|"     The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma     brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in     isocitrate dehydrogenase (IDH) mutated gliomas and IDH wild type gliomas.   "
42335|NCT02731508|"     Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may     restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and     suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance     after-effects of rehabilitation. In this double-blind, randomized controlled trial,     investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary     motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor     functional outcome, ipsilesional motor circuit excitability using transcranial magnetic     stimulation (TMS) and magnetoencephalography (MEG) measures.   "
42399|NCT02730676|"     This study assesses the nicotine pharmacokinetic (PK) parameters in adopters of electronic     cigarettes following a 12-hour tobacco and nicotine abstinence. The PK results of this study     will be compared to historical data on smokers obtained in prior studies, as well as on naïve     and short-term users of electronic cigarettes.   "
42336|NCT02731495|"     Traumatic brain injury is the leading cause of death and disability in young adults. Green     tea Epigallocatechin -3-gallate (EGCG) supplementation might favorably influenced many of the     processes mention in the secondary insult of TBI including neuroinflammation and     antioxidative damages.      The investigators aim to investigate whether treatment with Epigallocatechin -3-gallate     favorably affect outcomes in traumatic brain injury patients. Therefore, in the current     randomized double-blind clinical trial, 30 patients (15 patients in each group) with moderate     to severe head trauma admitted to university hospital intensive care unit will included.     Patients will either receive a daily oral dose of 400 mg EGCG or placebo for 7 days. The     major outcomes includes duration of mechanical ventilation, Glasgow Coma Scale (GCS), and     S100 protein level.   "
42337|NCT02731482|"     This study will investigate the short-and long-term effects of the home-based pulmonary     rehabilitation on peripheral muscle strength, functional capacity and quality of life in     patients with bronchiectasis. The participants will be randomized into two groups: control     group (usual care and recommendations for practice exercise) and training group, that will     perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight     weeks, three times a week. At baseline, immediately after finishing and after six months the     patients will undergo assessments.   "
42338|NCT02731469|"     BCD-131 is pegylated darbepoetin beta. BCD-131-1 is open clinical trial to evaluate     pharmacokinetics, pharmacodynamics, tolerance, safety and immunogenicity of single injection     of increasing doses of BCD-131 to healthy volunteers compared to Mircera® and Aranesp®.     Clinical trial will be conducted in two stages. On first stage the optimal dose for     therapeutic use of BCD-131 will be determined (subcutaneous injections). On second stage the     determined dose will be injected subcutaneously and intravenously.   "
42339|NCT02731456|"     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,     acclimatization and re-exposure to high altitude on psychomotor vigilance to measure     sustained attention.   "
42340|NCT02731443|"     Prospective observational study on epilepsy patients undergoing partial brain resection     surgery (i.e. anterior temporal lobectomy) to assess the change in dream content before and 3     months and 1 year after surgery using anonymized dream-recall questionnaires. A control group     of epilepsy patients undergoing diagnostic depth electrodes placement will complete the same     questionnaires pre- and postoperatively to asses the factor 'general anesthesia' as a     potential confounder.   "
42341|NCT02731430|"     this study compares the use of intrathecal morphine, to multimodal analgesic techniques for     postoperative pain management following laparoscopic bariatric surgery.   "
42342|NCT02731417|"     There are no set national guidelines for the management of postpartum bladder. There is     little evidence on the management of postpartum urinary retention and many hospitals have     implemented their own postpartum bladder care protocols.      Acupuncture has been implemented as an alternative course of treatment for urinary retention     with reports of spontaneous restoring of micturition in all of the patients. The     investigators aimed at examining if acupuncture is a useful tool to treat postpartum urinary     retention.   "
42343|NCT02731404|"     Background: Positive pressure pneumoperitoneum (PP) may involve adverse pathophysiological     changes, including increased intra-thoracic and ocular pressure, when combined with standard     ventilation. High frequency jet ventilation (HFJV) was reported to reduce the adverse     cardiovascular effects during laparoscopic cholecystectomy.      Aim: To study the effects of HFJV on intra-ocular pressure changes (reflecting intra-cranial     pressure) during laparoscopic surgery under PP.   "
42344|NCT02731391|"     To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.   "
42345|NCT02731378|"     A multicentre, randomized, open-label, parallel-group, active controlled non-inferiority     study   "
42346|NCT02731365|"     The purpose of this clinical study is to allow the investigation of local field potential     (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP     biomarkers observed as a function of disease symptoms, medication effect, fluctuations in     disease, and changes resulting from adjustments from current standard practices of DBS     programming. The data collected and LFP markers identified will serve as guidelines for     future stimulation predicted programming.   "
42347|NCT02731352|"     The purpose of this study is to assess the efficacy and safety of apatinib in locally     advanced 131I-refractory/resistant differentiated thyroid cancer   "
42348|NCT02731339|"     The aim of this study was to investigate the relationship among sagittal spinal curvatures,     mobility, and low back pain in women with and without urinary incontinence.   "
42349|NCT02731326|"     Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly,     is a major health problem. The long-term goal of this project is to use a personal, mobile     heart monitor to help patients better recognize recurrent AF and improve patients' ability to     better manage their condition. A total of 300 patients with a history of AF will be included     in the study, with 150 patients receiving an iPhone with the mobile monitoring device and     educational text messaging and the remaining 150 patients continuing with their regular     medical care. Each patient will be included in the intervention period for 6 months. The rate     of recurrent AF and treatments meant to manage AF and other heart conditions will be     determined for both groups. Patients in both groups will complete a series of questionnaires     at the start and end of the 6 month study period to look at differences in quality of life     and knowledge of AF.   "
42862|NCT02724618|"     There is a growing body of evidence exploring the role of curcumin as a radioprotector     against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor     cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate     cancer patients undergoing radiotherapy.   "
42351|NCT02731300|"     Background: Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic syndrome with high     pharmacoresistance. The treatment outcomes are still unsatisfied. The investigator previous     study of cathodal transcranial direct current stimulation (tDCS) in children with focal     epilepsy showed significant reduction in epileptiform discharges. The investigator     hypothesized that cathodal tDCS when applied over the primary motor cortex (M1) combined with     pharmacologic treatment will be more effective for reducing seizure frequency in participants     with LGS than pharmacologic treatment alone.      Material and Method:      Study participants were randomized to receive either:        1. pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS over          M1 for 20 min or        2. pharmacologic treatment plus sham tDCS. Measures of seizure frequency and epileptic          discharges were performed before treatment and again immediately post-treatment and 1-,          2-, 3-, and 4-week follow-up.   "
42352|NCT02731287|"     Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.     Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a     non-selective beta-blocker, is an emerging treatment which has been reported to be effective     and safe for the treatment of IH, especially for superficial hemangiomas. Investigators     hypothesize that treatment with topical timolol in the first two months of life, before the     proliferative phase or in early proliferative phase, may prevent from further growing and the     need to treat with oral propranolol.   "
42353|NCT02731274|"     The main purpose of this study was to investigate if a six months period of physical     exercise, could improve motor memory consolidation in elderly people on pedal dexterity   "
42354|NCT02731261|"     The main purpose of this study was to investigate if a six months period of physical exercise     could improve motor memory consolidation in elderly people.   "
42355|NCT02731248|"     Pulse oximetry screening of newborn infants increases early detection of critical congenital     heart disease and minimises the risk of circulatory collapse before surgery. This study     provides an update on the implementation of pulse oximetry screening in Turkey   "
42356|NCT02731235|"     In a randomized-controlled study the effect of high-intensity training, 5 days a week at home     for 12 weeks is tested in patients with lacunar stroke.   "
42357|NCT02731222|"     The objective of this study is to determine the degree of correlation between the clinical     severity of chronic venous disease and the prevalence of onychodystrophy. The completion of     the study will require a previous synthetic explanation of the aforementioned two diseases,     emphasizing the factors which have an impact on the proposed analysis.   "
42358|NCT02731209|"     The aim of the investigators work is to describe the urodynamic results in the CKD (chronic     kidney disease) grade 4 patients and to verify observations that urinary catheter may improve     kidney function in those patients.      100 patients with CKD grade 4 will do urodynamic examination.      All patients will be randomized into two groups / the intervention group that will be     inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be     monitored by creatinin values and the investigators will measure the time to dialysis in the     two groups.   "
42359|NCT02731196|"     Low back pain is common, costly and affecting up to 80% of the population with the lumbar     discectomy being a frequent spinal procedure for disc herniations. Pain & mobility     impairments persist in patients following microdiscectomy with long term issues of back pain.     The question remains as to why some patients recover quickly and without lasting difficulties     while other patients persist with prolonged disability following the same surgery. The     purpose of this study is to determine how to guide the patient towards full function and     evaluate the timing to initiate strengthening, neurodynamics and a walking exercise program.   "
42360|NCT02731183|"     Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with     life-threatening condition, and it is often related with bacterial overgrowth. Fecal     microbiota transplantation (FMT) results in restoration of the normal intestinal microbial     community structure. The investigators planned to observe the eﬃcacy of FMT in the treatment     of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal     tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and     remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and     gastrointestinal quality-of-life index(GIQLI) were evaluated.   "
42361|NCT02731170|"     this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive     Rehabilitation Treatment in Advanced Stages of Parkinson's Disease.      In the last years, several evidences highlighted the need of a multidisciplinary and     intensive approach to achieve good results in early stage of disease.      Hypothesis is that this approach is effectiveness also in moderate and advanced stages of     disease   "
42362|NCT02731157|"     The objective of this proposal is to test the feasibility of red blood cell (RBC)     rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of     RBC rejuvenation in this population to determine if a larger clinical trial powered to     definitively characterize the benefits of rejuvenation is warranted.      This is a small pilot study is to see if restoring important energy molecules (ATP and     2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution     (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects     will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6     transfusions (over approximately a 6-month period) in a pre-defined order to maximize     detection of any signal.   "
42363|NCT02731144|"     In this pilot randomized prospective controlled trial the investigators intend to compare the     use of a nutritional therapy based on caloric intake determined by indirect calorimetry and     high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake     usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).   "
42364|NCT02731131|"     This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy     and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination     with ribavirin in participants with CHD.   "
42410|NCT02730533|"     This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients     who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The     primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication     can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal     lesions.   "
42365|NCT02731118|"     Glaucoma is a complex and chronic eye disease which damages the optic nerve. One of the main     risk factors for the progression of glaucoma is IOP.      The aim of the study is to examine if Salovum, an anti-secretory factor (AF), can reduce the     level of the intraocular pressure (IOP) in the eye of patients affected by glaucoma.      Anti-secretory factor (AF) is an endogenous protein which controls the transport of water and     ions across the cell membrane. AF plays an important part in the immune system and has an     anti-secretory and anti-inflammatory effect.      The investigators' hypothesis is that Salovum can restore a normal salt-water balance in the     eye, which in turn would lower the IOP. This would eliminate or reduce the risk of subsequent     visual impairments/neurological damage.   "
42366|NCT02731105|"     Study to compare two gels that are used to treat acne vulgaris. It will be compared the     tolerability and effectivity following application of two combination topical acne products     clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide     2,5% gel (Epiduo® Gel).   "
42367|NCT02731092|"     To evaluate the safety and tolerability of three different lactoferrin doses in preterm     infants   "
42368|NCT02731079|"     Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies     have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the     investigators are unaware of any studies that compare outcomes between devices from the two     main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this     study is to compare intraoperative characteristics, such as time to create sleeve,     intraoperative bleeding, and time needed to load each cartridge, and post-operative     characteristics, such as any complication requiring readmission (leak or hemorrhage), further     surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy     with Covidien devices and Ethicon devices. Currently the investigators predominantly use     whatever device is cheaper, but cost should not be the primary decisive factor if one device     is superior to the other. If one device has better clinical outcomes, it should be the     preferred device regardless of cost. If neither proves superiority, the investigators can     justify using cost to determine which device to use in patient care.   "
42369|NCT02731066|"     This research will evaluate nutrition requirements for missions at high altitude (i.e. >7800     feet above sea level) and the information obtained can be used to optimize nutrient content     specifications for combat rations.      The objectives are:        1. Determine whether loss of lean body mass resulting from negative calorie balance over a          22-d period at high altitude can be prevented by increasing dietary protein intake.        2. Determine the efficacy of carbohydrate (glucose and fructose) supplementation on aerobic          exercise performance at sea level, acute exposure to high altitude, and in response to          22-d period of negative calorie balance at high altitude.        3. Determine cognitive function, sleep patterns, and behavioral responses to high altitude          and underfeeding.        4. Determine appetite and eating behavior in response to high altitude and sustained          underfeeding.        5. Examine the effects of high altitude, negative calorie balance, dietary intake          manipulations on gut health.   "
42370|NCT02731053|"     The purpose of this pilot study is to test the effectiveness of French adaptation of the     Blues program, a school-based indicated depression prevention intervention. The program will     be delivered by the endogenous psycho-social staff of 3 Montreal secondary schools to     adolescents with sub-clinical depressive symptoms and compared to a no-intervention     (Informational Brochure only) control condition, designed to represent the usual     intervention in these schools.   "
42371|NCT02731040|"     The purpose of this study is to determine whether women who have atypical subtrochanteric and     diaphyseal femoral fractures after treatment with bisphosphonates for osteoporosis, have a     genetic predisposition to these unusual fractures.   "
42373|NCT02731014|"     The aim of this trial will be to examine the short and long term effectiveness of dry     needling on pain, disability, and patient perceived improvements in patients with neck pain     attending physical therapy. The investigators hypothesize that patients who receive dry     needling, manual therapy, and exercise will achieve greater reductions in pain and disability     in the short (4 weeks) and long term (6 and 12 months) compared to those who receive sham dry     needling, manual therapy, and exercise.   "
42374|NCT02731001|"     The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis     and esophagitis grade II or higher by the use of proton therapy compared to photon     radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life,     loco-regional control, survival and late radiation induced side effects.   "
42385|NCT02730858|"     The purpose of this research study is to test a new way to deliver oncology and palliative     care for patients with metastatic breast cancer.        -  The goal of this study is to test a model where oncology and palliative care work          together to care for participants with metastatic breast cancer who were recently          admitted to the hospital or have new or worsening cancer involving their brain or the          fluid around the brain or spinal cord.        -  The investigators are studying whether participants who receive care from both teams          have better communication about their care and improved quality of life and mood          compared to those receiving care from only their oncologists.      The purpose of this randomized clinical trial is to conduct a randomized trial testing the     impact of the collaborative palliative and oncology care model or standard oncology care     models among patients with poor prognosis metastatic breast cancer. Participants assigned to     the intervention arm will participate in a series of structured palliative care visits,     following tailored clinical practice guidelines previously developed for patients with     metastatic breast cancer.   "
42915|NCT02723929|"     The purpose of this study is to investigate the effects of transcranial direct current     stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and     functional limitations in people with osteoarthritis of the knee. The investigators     hypothesize that there will be a decrease in pain levels with active stimulation, when     compared to sham stimulation.   "
42375|NCT02730988|"     Intentional weight loss in obese, older adults remains controversial. Although caloric     restriction, resulting in significant weight and fat mass loss, ameliorates many clinical     consequences of obesity, recommendation of intentional weight loss in aging remains     controversial. Reluctance stems, at least in part, from loss of lean and bone mass known to     accompany overall weight loss and potential exacerbation of age-related risk of disability     and fracture. Accordingly, current treatment guidelines call fhttp://google.wfu.edu/or     weight-loss therapy that minimizes muscle and bone losses for older persons who are obese and     who have functional impairments or medical complications that can benefit from weight loss.      Amount of dietary protein consumed during caloric restriction may be a key determinant in     maintaining fat-free mass during weight loss. Adequate dietary protein is essential for     skeletal muscle anabolism; and, epidemiological evidence in older adults point to a salutary     effect of protein intake above the current RDA (0.8 g/kg/day) on body composition. Indeed, a     recent position statement by the PRO-TAGE study group advises consumption of 1.0-1.2 g/kg/d     in older adults during weight-stable conditions to aid in the maintenance of lean body mass     and function. Practical achievement of this level of protein intake is often difficult for     obese, older adults undergoing weight loss, yet may be critical to offset weight     loss-associated lean mass loss. Preliminary data from our group show a lean mass sparing     effect of high protein consumption during caloric restriction. In post-menopausal women     undergoing a 5-month intentional weight loss program, consumption of a high (1.2 g/kg/day)     versus low (0.6 g/kg/day) protein diet was associated with 50% attenuation (17% vs. 37%) of     lean mass loss. While promising, results have yet to be translated to functional changes in a     tightly controlled trial of weight loss in obese, older adults.      The primary goal of this study is to determine whether adherence to a high protein (≥1.0     g/kg/d) weight loss program results in improved physical function by favorably affecting body     composition compared to weight stability in obese, older adults. This will be accomplished by     conducting a 24-week trial in 124 obese (BMI 30-40 kg/m2), older (65-79 years) men and women,     at risk for mobility disability, randomized to either: (1) high protein intake (≥1.0 g/kg/d;     n=62) during weight loss, or (2) weight-stable control (n=62).   "
42376|NCT02730975|"     ABIFOOD study is a randomized open-labelled, phase I study to evaluate food effect in the     pharmacokinetic parameters of abiraterone acetate (AA) at reduced doses, versus AA in fasting     conditions at conventional doses, in castration resistant prostate cancer (mCRPC) patients     who have progressed to docetaxel.   "
42377|NCT02730962|"     The purpose of this study is to determine whether changing the microbial composition in the     colon can improve metabolism of sugar in people who are on the verge of developing diabetes     (pre-diabetics). Study participants will undergo a fecal microbiota transplantation (FMT)     using material from lean donors, as well as a series of tests prior to and after the     transplant. The investigators will examine any changes in fecal bacterial composition     associated with FMT and determine if any observed changes have an influence on blood sugar     metabolism.   "
42378|NCT02730949|"     The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral     supplementation in addiction to folic acid compared to folic acid alone on glycaemic control     as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin     therapy.      A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50     years (13 males, 13 females), with disease duration > 1 year and BMI >25, attending as     outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome   "
42379|NCT02730936|"     This prospective early feasibility clinical study will collect information regarding the     safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue     during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e.,     Class II and Class III) surgical fields.   "
42380|NCT02730923|"     The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined     with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an     interesting therapeutic option for endometrial cancer with a manageable toxicity profile.      The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial     to evaluate the safety and efficacy of a combination treatment associating anastrozole to     AZD2014 in advanced endometrial cancer patients.      The study is divided in 2 steps :        -  A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014          + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled          (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of          product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014          will be applied in case of toxicity.        -  A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the          AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).   "
42381|NCT02730910|"     This study will determine the bioavailability of anthocyanins and phenolic compounds from two     purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched     wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product.     The purple wheat granola bars are an example of a food product that requires much less     intensive preparation and cooking, compared to the crackers. A comparison of bioavailability     between these two products should provide insights about how different processes and food     matrix influence anthocyanin bioavailability and metabolism.   "
42382|NCT02730897|"     Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS)     compared to open surgery in patients with cStage-I NSCLC . This finding questions the     oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar     and intrapulmonary lymh node dissection. However, these retrospective studies did not include     analysis of central tumor location, although central tumors have a reported higher chance of     N1 upstaging . Possibly, this creates a selection bias as surgeons might select central     lesions deliberately for open surgery in line with initial VATS feasibility reports   "
42383|NCT02730884|"     The goal of this clinical research study is to learn if rigosertib can help to control MF in     patients with anemia. The safety of this drug will also be studied.   "
42384|NCT02730871|"     The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering     effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to     Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular     hypertension.   "
42396|NCT02730715|"     This study aims to study the effects that two standard of care immunosuppression induction     regimens have on regulatory T cells (Treg) in live donor renal transplant recipients. Both     regimens are currently used in this hospital for early immunosuppression induction but the     effects on Treg numbers and function is not well understood and likely will impact long term     immune function.   "
42397|NCT02730702|"     This is a study whose focus is on understanding the clinical utility of rectal ultrastructure     in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering     Spectroscopy (LEBS).   "
42398|NCT02730689|"     The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg     and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered     alone in health male volunteers.   "
42386|NCT02730845|"     The present study will be carried to evaluate the efficacy of intra-articular 0.5 bupivacaine     with intra-articular or intravenous alpha-2agonist; Dexmedetomidine; for intraoperative     anesthesia and postoperative analgesia after arthroscopic knee surgery.      Arthroscopic knee surgery is one of the most common minimally invasive orthopedic procedures     in recent practice which is frequently performed as a day surgery procedures. It can be done     under general, regional or local anesthesia (LA) with or without sedation. It is associated     with varying amount of postoperative pain. Postoperative pain negatively influences patient's     early ambulation, rehabilitation and psychology which consecutively prolonged the hospital     stay.      Intra-articular administration of local anesthetic for knee arthroscopy is a well-documented     procedure that offers many advantages over other anesthesia types. Many anesthesiologists are     still trying to improve the technique of local anesthetic administration through using many     combinations with LA solutions in order to administer safe anesthesia to those patients and     to obtain a pain-free knee with good operating conditions.      Dexmedetomidine is a highly selective α2 adrenergic agonist. It has analgesic, sedative,     anxiolytic, hypnotic, sympatholytic, antihypertensive properties with anesthetic sparing     effects. It becomes an attractive alternative to the current opioids because it does not have     a respiratory depressant or addictive effect.   "
42387|NCT02730832|"     Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no     scales to evaluate the oral health of patients with schizophrenia. The only scales that do     exist are for the population at large, children or the elderly. Given the severely     deteriorated oral health in these schizophrenic populations, it is important to have a tool     to evaluate their perception of the quality of their oral health so as to better orientate     prevention programmes.      The aim of this study is to validate a tool to measure the perception of oral health in     patients with schizophrenia.      To do this, patients will be invited to complete a series of self-questionnaires relative to     the concept of oral health.   "
42388|NCT02730819|"     The purpose of this research study is to gather information on the effectiveness and     tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA)     approved topical medications for the treatment of moderate to severe melasma.   "
42389|NCT02730806|"     The purpose of this interventional study is to evaluate the effectiveness of the NLP PTSD     protocol in the event of PPPTSD in comparison with the common practice protocol. The study's     main hypothesis is that the implementation of both protocols will be equally effective and     result in reduction of the overall PTSD level.   "
42390|NCT02730793|"     This study is designed as a masked, two center, randomized, placebo-controlled pilot study to     evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects     with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth     University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential     subjects will be identified in each site's CF clinic.   "
42391|NCT02730780|"     This study aims to assess the natriuretic peptide response to dietary salt loading in     African-American individuals compared with white individuals.   "
42392|NCT02730767|"     Exercise can play a major role to mitigate or even prevent late effects in cancer survivors,     such as cardiovascular disease, obesity, osteoporosis, fatigue, depression, reduced quality     of life, mental health and physical performance.      The objective of this study is to assess the effect of an exercise program of 1 year on     cardiovascular health, obesity and diabetes, osteoporosis, physical fitness, mental health     and quality of life in childhood cancer survivors. The investigators will recruit childhood     cancer survivors aged 16 years and above from three Swiss paediatric oncology clinics and     randomize them into an intervention and a control group. The intervention group will be asked     to increase physical activity for 1 year by at least 2.5 hours of intense physical activity     weekly. Regular feedback will be given via a step counter, an online activity diary, and by     the centre staff. The control group participants will keep their activity level constant. All     participants will be seen after 3, 6 and 12 months to assess health and quality of life     parameters over one year. After 1 year, the control group is offered to receive the same     intervention to profit as well from an active lifestyle.      If the program shows to be effective, a complete package will become available to interested     centres treating paediatric cancer patients in Switzerland to promote exercise in all     survivors. The program will allow clinicians without previous experience in exercise     counselling to improve the care of their patients.   "
42393|NCT02730754|"     This study aims to determine which factors are related to change in diabetes-related distress     and change in depressive symptoms after three years of follow-up in Asian adults with type 2     diabetes mellitus in primary care. The investigators will explore the impact of patient     demographics, cardiometabolic control, medications adherence, health-related quality of life,     self-efficacy and self-management behaviors on diabetes-related distress and depressive     symptoms.   "
42394|NCT02730741|"     The mechanisms of diarrhoea under metformin are poorly known. Recent data indicate that a     change in gut flora might be responsible for this intestinal disorder. The effect of     metformin on the gut flora has been extensively described. It has been shown that the     therapeutic effect of metformin depends on the microbiota. In agreement with these data, a     recent publication has shown that metformin's main site of action in humans was the     intestine. In light of these results, it now seems plausible that metformin's effect on the     gut flora is responsible not only for its therapeutic effect but also for its undesirable     digestive effects. In this respect, Lactobacillus rhamnosus has shown anti-diarrhoeal effects     (approximately 50% reduction in diarrhoeas) in the contexts of infection-caused dysbiosis and     post-antibiotic dysbiosis.      Hypothesis: Taking into account the favourable effect on intestinal dysbiosis-induced     diarrhoeas observed with Lactobacillus rhamnosus, we put forward the hypothesis that     Lactobacillus rhamnosus Lcr35® will have a favourable effect on metformin-induced diarrhoea.   "
42395|NCT02730728|"     The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous     catheter nerve block done via the adductor canal method in adult patients who have under gone     total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go,     ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be     used for comparison.   "
42863|NCT02724605|"     The aim of the study is to detect if the storage duration of red blood cells has impact on     some biochemical parameters after intra operative transfusion in pediatric trauma patient   "
42401|NCT02730650|"     This study will be a prospective study of patients who undergo platelet-rich therapy (PRT)     for facial rejuvenation at NYU Langone Medical Center. PRT has been increasingly used for     wound healing, fat grafting, hemostasis as well as facial enhancement. PRT involves injection     of patient's own platelets and fibrin, and has evolved as a less invasive technique for     facial rejuvenation compared to more traditional techniques. Through the use of pre and post     treatment photos, in addition to the FACE-Q Questionnaire and a clinician assessment, it is     our hope that we will confirm the rejuvenating capabilities of PRT.   "
42402|NCT02730637|"     This study examines the clinical relevance of early biomarkers to detect and prevent acute     kidney injury. High-risk patients for developing acute kidney injury will be screened at     initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In case     of elevated readings patients will be randomized in two arms: The control group will be     treated with standard care, the intervention group will receive an early nephrologic     consultation.   "
42403|NCT02730624|"     This is prospective study to assess the pharmacodynamics (t>MIC) of 4.5 g every 6 h of     piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following     administration by a 30 min infusion.      Clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs, APACHAE     II score, BUN, Cr and fluid balance will be collected.      Fifty patients will be enrolled in this study. Piperacillin pharmacokinetic study will be     carried out during the piperacillin/tazobactam therapy.      Each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe sepsis     or septic shock, blood samples (approximately 3 ml) will be obtained by direct venipuncture     at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after piperacillin/tazobactam therapy.      Concentration of piperacillin in plasma will be simulated in Monte Carlo technique to get     PK/PD index and reported to % PTA and % CFR.   "
42404|NCT02730611|"     Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract cancers     (GBTC) observed in Western populations may be related to obesogenic lifestyle factors and     their metabolic consequences, such as metabolic syndrome (MetS), inflammation and altered     production of bile acids (BA). Such lifestyle behaviours may induce changes in the gut     microflora which in turn affect BA profiles, increasing their carcinogenicity. Some elevated     BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve     gastrectomy may change bile acid composition.      The aims of this study are:        1. whether specific presurgical bila acid profiles are predictive of efficacy of vertical          sleeve gastrectomy, reflective of liver function and metabolic dysfunction;        2. whether specific presurgical bile acid profiles are predictive of the efficacy of sleeve          gastrectomy   "
42405|NCT02730598|"     Osteoarthritis of the knee (KOA) is the most common cause of disability in older adults.     Osteoarthritis involves a loss of cartilage, which acts like a cushion between the bones as     well as changes in the bones of joints. Once the joint cartilage is gone, the body does not     produce new cartilage. Joint damage can contribute to pain. Currently, treatment for pain     associated with knee osteoarthritis includes exercise. However, exercise at a medium- to     high-intensity level can be problematic for people with knee pain. Because exercise is a     common treatment for knee pain but many people experience pain during exercise, researchers     hope to find a safer and more effective exercise method to strengthen the muscles around the     knee.      Both aerobic exercise and resistance exercise are recommended for the treatment of people     with knee pain. However, pain can be a barrier to participating in exercise at a moderate or     vigorous intensity. Electrical stimulation of muscles holds potential to allow effective     exercise to be completed at tolerable intensities. Transcutaneous electrical nerve     stimulation (TENS) is the use of very low electric currents produced by a device to stimulate     the nerves, to treat pain. Neuromuscular electrical stimulation (NMES) uses low electrical     current to cause muscles to contract.      By doing this study, the investigators hope to learn if a hybrid training system (HTS), using     a combination of NMES and walking, is effective in strengthening muscles in people with knee     pain, aching or stiffness.      In this pilot study, the investigators will use walking with TENS as conventional exercise.      Randomized controlled trial will be conducted to compare the effect of walking augmented by     HTS with walking without HTS. The investigators will evaluate the relative advantages of     training that combines HTS with conventional walking exercise on the improvement of muscle     strength, physical function, and pain relief in obese women with frequent knee symptoms.      Study Hypotheses: Compared with walking with sensory TENS, walking with HTS will:        -  1 increase quadriceps muscle strength.        -  2 decrease knee pain.      Exploratory Hypotheses:        -  3 improve physical function.        -  4 increase PPT (improve central sensitization).        -  5 improve self-reported quality of life.   "
42406|NCT02730585|"     The diagnosis of acute appendicitis is difficult and despite important advances in medical     sciences, detailed patient questioning and precise medical examination are the main keystones     of the diagnosis of acute appendicitis and up to now, results still unsatisfactory.   "
42407|NCT02730572|"     The primary purpose of this study is to identify whether, after adjustment for confounders     via stratification on a propensity score and adjustment for calendar year, the combined     endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of     immediate release [IR] methylphenidate, 3. beginning a new attention deficit hyperactivity     disorder [ADHD] medication, or 4. stopping both Concerta and the long acting [LA]     methylphenidate {authorized generic [AG] methylphenidate or equivalent generic [EG]     methylphenidate} that was begun on the index date), differs between participants who switch     from branded Concerta to the EG formulations versus participants who switch from branded     Concerta to the AG formulation.   "
42408|NCT02730559|"     The primary focus of this proposal is to address growing concern of overweight/ obese     adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled clinical     trial to compare the effectiveness of Motivational interviewing (MI) interventions with the     parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be recruited     from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad will have     more success due to the possible synergetic effect compared to adolescents alone. The study's     primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary outcomes     include overall improvement in their lifestyle and their responses to the MI intervention.   "
42409|NCT02730546|"     This phase Ib/II trial studies the side effects and best way to give pembrolizumab with     combination chemotherapy and radiation therapy before surgery and to see how well it works in     treating adult patients with gastroesophageal junction or gastric cardia cancer that has     spread from where it started to nearby tissue and can be removed by surgery. Monoclonal     antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting     certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Giving pembrolizumab, combination chemotherapy, and radiation therapy before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed.   "
42411|NCT02730520|"     Worldwide, respiratory diseases have a significant impact on morbidity and mortality of     individuals.Tobacco, lifestyle and certain allergens such as dust mites play an important     role in the prevalence and morbidity of these diseases. Scientific literature indicates that     sensitization to allergens and respiratory diseases (asthma, rhinitis, chronic obstructive     pulmonary disease) are closely linked. Moreover, smoking has an effect on allergen     sensitivity.      To make a diagnosis of allergic sensitization, skin tests are performed in the patient. One     of the methods used is the technique of prick test. In practice, a drop of purified     allergen extract is placed on the patient's skin (arms or back). A little dosis of the     product is then injected in the epidermis. If fifteen minutes later, there is an edematous     reaction, its diameter is measured in millimeters. From 4 mm, it is considered that the     patient is sensitized to the tested foods or allergens.This technique is painless and     convenient to patients of all ages, including newborns or conversely very aged patients.      This is a retrospective study based on the encoding and statistical analysis of data     collected in patients followed within the Immuno-Allergology Service of the CHU Brugmann     Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens     tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF),     blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree,     cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.      At least 1400 files will be analyzed.      Patients will be distributed in six age groups.The results of the allergen skin tests will be     encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for     each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI     and residential area on the allergic reactivity will also be assessed in the overall     population and within each age group.      The main objective is to evaluate the effect of age on the skin test positivity. The     secondary objective is to highlight the environmental factors that have an impact on allergic     diseases.   "
42412|NCT02730507|"     Lumbar degenerative diseases (LDD) are an increasingly common condition affecting millions of     patients worldwide. LDD can impact not only function, but can also become markedly disabling     and cause severe chronic pain. Recent studies support the idea that analysis of sagittal     balance is a crucial keypoint to optimize the management of lumbar degenerative diseases,     especially when spinal instrumentation is intended.      The first treatment of these pathologies is a medical treatment (medications, physical     therapy and exercise). Surgical treatment is frequently necessary if the symptoms worsen and     is generally a posterior spinal fusion with instrumentation (screws, hooks and rods) and bone     graft. Basic principle of the surgery is to realign the spine along the rod.      Despite documented techniques for surgical planning, it appears that a significant number of     patients are ultimately under-corrected after surgery Realignment failure has not only been     associated with poor functional outcome but also major complications, such as pseudoarthrosis     and rod breakage, which often results in additional surgical procedures.      From a pragmatic point of view, there are two main reasons for realignment failure: poor     surgical planning and poor execution. One of the assumptions is that perioperative manual     bending of the rod may not always allow the surgeon to restore the sagittal parameters as     intended.      A new concept of patient-specific rod (PSR) is now being proposed by a French manufacturer in     order to enable an optimal correction and surgical stabilization of the spine. PSR are     designed to fit with the patient's unique sagittal spine profile and with surgeons' surgical     planning. However, no relevant clinical data is currently available to support the expected     medical benefit of this new technology.      The objective of the study is therefore to carry out a study hypothesizing that the use of     PSR could improve the percentage of patients whose sagittal profile is optimally corrected     after spinal surgery, as well as the patient's quality of life.   "
42413|NCT02730494|"     The primary objective of this study is to study the vaginal flora colonisation equivalence     between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0     (V1) and Dend of treatment.   "
42414|NCT02730481|"     This is a multicenter, open-label, safety study. Eligible subjects will be adults with     advanced malignancies. The study includes a pretreatment and treatment phase. The     pretreatment phase consists of screening and baseline periods. The treatment phase consists     of 4-week treatment periods and a follow-up period.   "
42415|NCT02730468|"     The purpose of this study is to evaluate the performance of the Karius Infectious Diseases     Plasma Sequencing Assay in patients who present to the emergency room with sepsis.   "
42416|NCT02730455|"     The primary objective of the study is to assess the clinical effects of natalizumab versus     placebo in acute ischemic stroke on clinical measures of functional independence and     activities of daily living. The secondary objective of the study is to explore dose and     exposure response and the clinical treatment effects of natalizumab versus placebo in acute     ischemic stroke on the following: measures of independence, activities of daily living,     neurologic function, quality of life, cognition, and safety and tolerability   "
42417|NCT02730442|"     This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV     over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8,     after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4     days (Days 5 to 8). Up to twenty subjects will be included in two cohorts which will undergo     the same dosing schedules of fluconazole and F901318 and undergo the same procedures. The     first cohort will consist of 12 subjects studied in two groups of six subjects each. If there     is clearly a difference in F901318 kinetics detectable before and after dosing with     fluconazole in this first cohort, the second cohort will not be studied. If there is no clear     difference, the second cohort will also be studied to give a final result. In this cohort,     based on the pharmacokinetic findings in cohort 1, the dose of F901318 may be increased to up     to 4 mg/kg to establish a dose suitable for phase 2 evaluation. PK sampling for plasma     F901318 will continue from before the first dose up to and including 72 hours after dosing.     PK sampling for fluconazole will continue from before the first dose and up to 72 hours after     the fifth dose. A follow up visit will be conducted 7 +/- 2 days after discharge from the     clinical unit following completion of blood sampling following the second dose of F901318 and     the fifth dose of fluconazole.      The second part of the study will take place if no appreciable change in the pharmacokinetics     of either F901318 or fluconazole has been observed in either the first or the second cohorts     in the first part of the study. This second part will enrol 12 subjects. These subjects will     receive fluconazole 800 mg daily for one day (Day 1) and 400 mg daily orally for 4 days (Days     2 to 5) in combination with F901318 which will be given in a dose of up to 4 mg/kg IV bid for     one day (Day 1) followed by 7 doses of intravenous F901318 up to 2.5 mg/kg bid (Days 2 to 5).     Pharmacokinetic profiles of F901318 and fluconazole will be obtained during dosing and over a     72-hour period following the final dose of both compounds.   "
42418|NCT02730429|"     This randomized double-blind, placebo-controlled phase 2 trial is evaluating superiority of     Letrozole-palbociclib combination versus letrozole-placebo combination in ER positive     endometrioid adenocarcinoma of endometrium   "
42419|NCT02730416|"     This study will evaluate the role of addition of an anti-angiogenic agent     (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance     treatment in primary advanced or with first relapse of endometrial cancer.   "
42420|NCT02730403|"     This is an observational, ancillary study intended to describe opioid use among opioid use     disorder patients following their discharge into the community from inpatient detoxification     and/or short-term residential treatment programs affiliated with parent study CTN-0051, which     assessed the comparative effectiveness of extended release injectable naltrexone (XR-NTX,     Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of     relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high     affinity partial agonist indicated for maintenance treatment of opioid dependence, as     pharmacotherapeutic aids to recovery.   "
42421|NCT02730390|"     The primary objective of this post marketing surveillance (PMS) is to determine the safety     and efficacy of probucol in lowering the level of serum cholesterol in the blood.   "
42422|NCT02730377|"     This trial is conducted globally. The aim of the trial is to investigate efficacy in     controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment     vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects     with type 2 diabetes.   "
42424|NCT02730351|"     This is a multicenter, randomized, double-blind, double-dummy, crossover study with two     2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in     up to eight study visits and have a follow up phone call approximately a week after the last     clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM     and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM     and continue over a period of approximately 24 hours. Subjects will be required to attend     three clinic visits during this 24-hour period. An exercise challenge (using a treadmill)     will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment dose     in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7.     Spirometry will be conducted at specified visits and prior to and after each exercise     challenge.      Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to     four weeks with intranasal corticosteroids followed by a repeat screening visit to determine     eligibility prior to entry into the study.      Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram     (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized     treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind     Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately     7-days after completing Treatment Period 2. The total duration of study participation is     approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis.      The primary objective of the study is to evaluate the protective effect of fluticasone     furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP)     250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult     subjects aged 12 to 50 with persistent asthma.      ELLIPTA, ACCUHALER, and DISKUS are registered trademarks of the GlaxoSmithKline group of     companies.   "
42425|NCT02730338|"     A Study to determine if high intensity aerobic and resistance training plus psychosocial     support increases overall survival compared to psychosocial support alone in patients with     metastatic castrate-resistant prostate cancer.   "
42426|NCT02730325|"     The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated     and compared to matching placebo in two distinct patient populations:      I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium     difficile (C. difficile) at time of admission and are receiving vancomycin.      II. Hospitalized UC patients who tested negative for C. difficile at time of admission.   "
42427|NCT02730312|"     The purpose of this study is to determine the safety and tolerability of weekly intravenous     (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after     the first dose, and then to determine the MTD after second and subsequent infusions.   "
42428|NCT02730299|"     This study is an open-label, controlled, multicenter, international, Phase III, randomized     study of transplantation of NiCord® versus transplantation of one or two unmanipulated,     unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid     leukemia, myelodysplastic syndrome or chronic myeloid leukemia, all with required disease     features rendering them eligible for allogeneic transplantation.   "
42429|NCT02730286|"     Objective: To evaluate what factors contribute to activity limitations in subjects with     rheumatoid arthritis considering the International Classification of Functioning, Disability     and Health model.      Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using     instruments to measure five constructs of the component activities.   "
42430|NCT02730273|"     This investigation is designed to evaluate the performance (leak and comfort) as well as the     participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea     (OSA) participants. An important factor in this investigation will be the testing of two     different seal sizes on the participants (medium and large size). A total number of 12     participants who currently use nasal or nasal pillow masks will be recruited for the trial.     Participants have been selected based on their anthropometric measurements collected in     previous trials (CIA-103). Participants from previous NZ trials may be recruited into this     trial with their consent. All the participants will be recruited from the Fisher & Paykel     Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District     Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).      Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight     polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be     collected from the participant during the first visit, 7 days of CPAP usage data will be     downloaded and stored for analysis. The participant will use the trial device on their usual     Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration     of the trial.   "
42431|NCT02730260|"     Social support is poorly understood but likely to influence outcomes of behavior change     efforts. Social support may take a directive or nondirective approach. In directive support,     the person attempting a behavior change is told what to do and even what to think. In     nondirective support, the person attempting the behavior change decides what to discuss. In     some contexts, interactions of race or income with social support have been reported. This is     a randomized controlled trial of directive and nondirective coaching in the context of a     smoking quitline offered to employees of two large corporations.   "
42432|NCT02730247|"     The subjects who take part in this clinical research study have advanced non-small cell lung     cancer (NSCLC) that has been previously treated with other drugs. If they join this study,     they would receive ramucirumab (Cyramza ®) in combination with nab-paclitaxel (Abraxane®).     Ramucirumab given with nab-paclitaxel is considered an investigational drug combination to     use in this type of cancer because giving these two drugs together has not been approved by     any regulatory authority like the US Food and Drug Administration (FDA) for NSCLC cancer.     Ramucirumab works by slowing or stopping the growth of cancer cells. Nab-Paclitaxel works by     blocking the ability of cancer cells to break down the internal 'skeleton' that allows them     to divide and multiply. With the skeleton still in place, the cells cannot divide and they     eventually die.   "
42433|NCT02730234|"     The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and     adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR)     at 6 months follow-up when compared to historic data from PTA alone in the treatment of     femoropopliteal (FP) arterial In-stent restenotic (ISR) disease.      This is a prospective, multicenter, single arm study evaluating the investigational use of     Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of     FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category     (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old     balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the     field.   "
42456|NCT02729935|"     Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the     supra-pubic region; reported postoperatively in patients who have had urinary catheterization     intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for     preventing CRBD in patients undergoing catheterization after transurethral resection of     bladder tumor (TURBT).   "
42434|NCT02730221|"     A prospective observational study in the Intensive Care Unit and the Medium Care Unit in a     university hospital in Amsterdam. Recent studies show that administrative tasks occupy more     than 30% of the workload. One-third of these administrative tasks is unrelated to care. The     administrative workload of physicians and nurses will be observed and quantified using two     different methods. The amount of time physicians and nurses are logged on into the patient     data management system (PDMS) will be measured and the time spent on different work tasks     will be monitored with a work sampling method. Two different patient data management systems     will be compared.   "
42435|NCT02730208|"     The primary purpose of study is to evaluate the treatment effect of VX-661 in combination     with ivacaftor (VX-661/ivacaftor) on chest imaging endpoints using low-dose computed     tomography (LDCT) at Week 72, and to evaluate the safety of VX-661/ivacaftor through Week 72   "
42436|NCT02730195|"     This phase II trial studies how well pioglitazone hydrochloride and tyrosine kinase inhibitor     (TKI) therapy works in treating patients with chronic myeloid leukemia (CML) that has come     back after a period of improvement (relapsed) after a first TKI discontinuation. TKI may stop     the growth of cancer cells by blocking certain enzymes need for cell growth. Although TKI     therapies are effective against CML, there are residual cancer cells called leukemia stem     cells that are able to hide from TKIs. Pioglitazone is a drug approved by the Food and Drug     Administration to treat diabetes and has been shown in laboratory studies to increase CML     stem cell death when given together with TKI therapy. Giving pioglitazone with TKI therapy     may be effective in treating patients with CML.   "
42437|NCT02730182|"     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,     acclimatization and re-exposure to high altitude on postural control   "
42438|NCT02730169|"     The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese     subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24     weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a     6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268     subjects.   "
42439|NCT02730156|"     Prospective interventional trial in lowlanders evaluating effect of acute exposure,     acclimatization and re-exposure to high altitude   "
42440|NCT02730143|"     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,     acclimatization and re-exposure of high altitude on nocturnal breathing pattern.   "
42441|NCT02730130|"     The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on     the patient and areas of cancer in their body that did not receive radiation therapy.   "
42442|NCT02730117|"     Does Early Initiation of Renal Replacement Therapy Have an Impact on 7-day Fluid Balance in     Critically Ill Patients with Acute Kidney Injury with Positive Furosemide Stress Test?: a     Multicenter Randomized Controlled Trial   "
42443|NCT02730104|"     The purpose of this trial is to assess time to disease progression of patients with locally     advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide     Depot. This is an observational study therefore all data collected will be in accordance with     the routine practice of physicians.   "
42444|NCT02730091|"     This study is designed to evaluate the clinical effects of the addition of metronomic oral     vinorelbine to letrozole and anastrozole. The study will compare the efficacy and     tolerability of oral metronomic vinorelbine administered in combination with letrozole or     anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer     without resistance to Aromatase Inhibitors (AI).   "
42445|NCT02730078|"     The purpose of the clinical trial is to evaluate the effectiveness of a relatively simple and     short value-based emotion-focused educational programme in adults with type 2 diabetes     (VEMOFIT) on diabetes-related distress, depressive symptoms, illness perception, medication     adherence, quality of life, diabetes self-efficacy, self-care and clinical outcomes.   "
42446|NCT02730065|"     Introduction: Cerebral small vessel disease (SVD) is associated with age-related disabilities     including dementia, depression, physical and functional impairment. Chinese are more prone to     developing SVD than Caucasians. Physical exercise may improve multiple negative consequences     associated with SVD.      Objective and hypothesis to be tested: To examine the effects of a 24-week structured aerobic     dance training on cognition, mood, physical and daily functions in stroke and dementia free     older adults with SVD, and whether such effects are mediated through improved cerebral     vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired in SVD.      Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic     dance training upon cognition, mood, physical and daily functions on 110 community dwelling,     stroke- and dementia-free persons aged ≥65 with MRI evidence of significant SVD, defined as     the presence of multiple (≥2) lacunes and/or early confluent or confluent WML.      Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured     therapist-led group aerobic dance training with home practice or simple stretching plus     health education control group.      Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using     Transcranial Doppler at baseline, weeks 12, 24 and 36.      Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed     using mixed effects models. Mediation effects of CVR between aerobic dance training and     treatment outcomes tested using mediation models.      Expected results: In persons with significant SVD, aerobic dance training improves cognitive,     mood, physical and daily functions and such effects are mediated by changes in CVR.   "
42455|NCT02729948|"     This pilot clinical trial studies how well tethered capsule endoscope works in screening     patients with Barrett esophagus (BE), a condition where the lining of the esophagus has     changed or has been replaced with abnormal cells that may lead to cancer also called     esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer,     patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients     are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered     capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to     it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the     esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using     the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients     with BE without the need for sedation or anesthesia, thus eliminating the associated risks     and costs associated with EGD.   "
42447|NCT02730052|"     The proportion of hypertensive patients achieving adequate blood pressure control meeting     guideline targets remains low. Of those patients on blood pressure lowering drugs, only 50%     reach control.      Objectives:        1. Test the feasibility of telemonitoring of blood pressure in uncontrolled hypertensive          patients.        2. Investigate whether telemonitoring enabled self-measurement of blood pressure leads to          faster blood pressure control than self-measurement without telemonitoring.        3. Secondary endpoints include adverse effects, assessment of quality of life, adherence, a          log of technical problems, and cost-effectiveness.      Methods:      Randomised parallel-group study consisting of 4 stages.        -  Screening to check for eligibility.        -  Randomisation in a 1:1 proportion to control or experimental arm: In the control arm,          doctors will receive reports on the self-measured blood pressure based on diary cards;          in the experimental group, doctors will receive weekly reports via telemonitoring.        -  Treatment period: Doctors will adjust treatment according to the present guidelines of          Hypertension. Blood pressure control is a home blood pressure below 135 mm Hg systolic          and 85 mm Hg diastolic. Once blood pressure control is achieved the treatment period          ends.        -  Late follow-up: Assessment of blood pressure control at home 3 months after completion          of the treatment period by means of telemonitoring.      Sample size: 120 patients per group. Patients: recruited at clinics from Uruguay and     Argentina.      Main Inclusion Criteria:        -  Women and men, age range 20 to 80 years.        -  Uncontrolled hypertension and new diagnosed hypertension with a self-measured blood          pressure at home of 135 mm Hg systolic and/or 85 mm Hg diastolic or more;        -  Patients should be willing to accept adherence checking during follow-up and sign an          informed written consent.      Exclusion Criteria        -  Patients emotionally or intellectually not capable of measuring their blood pressure at          home;        -  A clinical or social context, which is suboptimal for the self-measurement of blood          pressure;        -  Pregnancy;        -  Alcohol or substance abuse or psychiatric illnesses;        -  Participation in another study. Expected outcomes: blood pressure control will be          achieved faster in the telemonitoring group.   "
42448|NCT02730039|"     The purpose of this project, entitled Meaning-Centered Psychotherapy Training for Cancer     Care Providers, is to develop a multi-modal training program in Meaning-Centered     Psychotherapy (MCP) for multidisciplinary cancer care clinicians who provide psycho-oncology     and psychosocial palliative care services for cancer patients.   "
42449|NCT02730026|"     The control of pain, swelling and trismus in patients undergoing oral and maxillofacial     surgery is frequently performed through the administration of non-steroidal anti-inflammatory     drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and     crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and     ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg     omeprazole) in 50 patients aged 18 years or older that require removal of both lower third     molars symmetrically positioned. After collection, data will be analyzed by means of graphs     and tables to allow the appropriate analyses. Paired t-test will be used to compare the     duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of rescue     medication and postoperative pain parameters (visual analog scale). Data of mouth opening     and swelling will be statistically analyzed through analysis of variance (ANOVA) followed     by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results     will be presented as mean ± standard deviation of the mean.   "
42450|NCT02730013|"     This is a 3 month cluster randomized controlled trial using a square-stepping exercise     program (a.k.a. mind-motor exercise) in retirement and long-term care residences to improve     global cognitive functioning in older adults with and without cognitive impairments. The     investigators intend this project to be pragmatic and therefore will include residents with     dementia and walking aids if the participants wish to participate. The primary outcome is     global cognitive functioning, secondary outcomes include: single and dual task gait (only     completed with those without dementia), oculomotor functioning, and functional fitness. The     investigators hypothesize that there will be improvements in primary and secondary outcomes     in the intervention group.   "
42451|NCT02730000|"     Given the clinical damage caused by errors commonly made during the dosage and handling of     glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated     ionomer has been recommended for final restorations. However, the initial cost of the     encapsulated MIC is higher when compared to the material handled manually. The objective of     this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV     Riva Self Cure and Equia used as a restorative material in atraumatic restorations     (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and     occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC,     (3) assess whether the child's caries experience influences the longevity of atraumatic     restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP     municipality. Randomization will be performed in a stratified manner by the conditions: type     of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV -     Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and     18 months by two trained examiners blind to the groups (intra- and inter-rater agreement     above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival     analysis and log-rank test. To evaluate the association between longevity and variable Cox     regression test will be applied. For the cost analysis will be used analysis of variance.   "
42452|NCT02729987|"     The purpose of this pilot study is to explore the effect of an online facilitated discussion     group on engagement with a stress management intervention delivered to employees in the UK     via the Internet. The investigators primary hypothesis is that the intervention group with     access to an online facilitated discussion group (delivered via a message board) will show     greater engagement than the intervention group that does not have access to the discussion     group. The investigators also hypothesise that participants in the intervention groups will     improve significantly on psychological distress and subjective wellbeing measures compared to     the waiting list control group, and that the group with access to the online facilitated     discussion group will show the greatest improvement.   "
42453|NCT02729974|"     This study evaluates the use of rapid tests for hematocrit and clotting function in women     undergoing surgery for placenta accreta. Half of participants will have these rapid tests     performed during surgery to guide blood product transfusion and the other half will have     standard lab tests performed to guide transfusion.   "
42949|NCT02723487|"     The primary objective of this study is to assess differences in postoperative pain     experienced by pediatric patients having transversus abdominis plane block block with     bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv     analgesia after Laparoscopic surgery.   "
42478|NCT02729649|"     ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable     for extended home rehabilitation and prolonged hospital rehabilitation without therapist     supervision. The device contains several games which are structured as exercise for disabled     patients. The primary aim of this study is to correlate efficacy of the arm training with     ArmAssist robot system to conventional care modified by duration and structure of exercise.     The secondary aim of this study is to measure the correlation between standard clinical     assessment scales and ArmAssist-based assessment metrics.   "
42457|NCT02729922|"     CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the     pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to     help management of selected heart failure patients. Heart failure patients with NYHA class     III heart failure, irrespective of the left ventricular ejection fraction, and a previous     hospital admission for heart failure in the past 12 months, without stage IV or V chronic     kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a     registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily     heart failure hospitalizations, heart failure related quality of life and re-admissions.   "
42458|NCT02729909|"     The purpose of this study is to evaluate the efficacy and safety of oral administration of 24     ug of lubiprostone twice daily (BID) for 4 weeks in participants with chronic idiopathic     constipation (CIC) compared with placebo.   "
42459|NCT02729896|"     This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of     obinutuzumab + Atezo + Pola in participants with relapsed or refractory FL and rituximab +     Atezo + Pola in participants with relapsed or refractory DLBCL. The study will include an     initial dose-escalation phase designed to determine the recommended Phase 2 dose (RP2D) for     Pola in this treatment combination, followed by an expansion phase in which Pola will be     given at the RP2D. All participants will receive induction treatment with obinutuzumab +     Atezo + Pola for 6 cycles. FL participants achieving a complete response (CR), partial     response (PR), or stable disease (SD) at the end of induction (EOI) will receive maintenance     treatment with obinutuzumab + Atezo and DLBCL participants achieving a CR or PR at EOI will     be eligible to receive consolidation treatment with rituximab + Atezo.   "
42460|NCT02729883|"     This pilot clinical trial studies Take the Fight in supporting and empowering patients with     cancer through their treatment process. Patients with cancer are faced with many obstacles     created by the current state of the healthcare system. The purpose of Take the Fight is to     train college students, also called patients' navigators or strategists, to assist and     support patients to navigate into the healthcare system and receive the care they need. The     strategists are matched with patients and attend/coordinate most patients' medical     appointments. The strategists also advance communications between the patient and the medical     staff to facilitate both the exchange of medical information as well as increase the     patient's compliance with treatment. Take the Fight may improve the health and quality of     life outcomes of cancer patients during critical treatment periods by increasing treatment     compliance, eliminating barriers to better care, and increasing clinical trial participation.   "
42461|NCT02729870|"     Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The     investigators investigate oral glucose gel for its effectiveness in rapidly reducing     ketoacidosis and for improvements in oral hydration therapy success.   "
42462|NCT02729857|"     The aim of the study is to understand more about how different fatty acids modulate     postprandial lipid metabolism and inflammatory response.   "
42463|NCT02729844|"     NeoLifeS is a cohort follow up study that prospectively collects data of regular care of     children born preterm in the University Medical Center Groningen (UMCG) and aims to improve     the quality of care for these children.      NeoLifeS-Heart is a sub-study that focuses on the problem that a high proportion of preterm     infants develop cardiovascular disorders. Related to the immaturity of their lungs, preterm     infants are at risk to develop the condition Bronchopulmonary dysplasia (BPD). Also, the     vasculature of the lungs is often not fully developed, making them more vulnerable for the     development of Pulmonary Hypertension (PH), a high blood pressure in the lungs. 15-20% of the     infants with extremely low birth weight are believed to develop PH, this proportion has been     suggested to raise to 50% in infants with severe BPD. The presence of PH significantly     worsens the prognosis and survival of these children.      The condition PH is insufficiently characterized. Knowledge of incidence, prevalence, risk     factors for the development of PH and survival, will be the first step in improving detection     strategies, possible treatment options and thereby prognosis and survival of these children.      Objective: To determine the incidence and prevalence of PH in preterm infants. In addition we     aim to identify risk factors for the development of PH and determine the survival and     prognosis of these preterm infants.      Study design: A prospective cohort study. Study population: All preterm infants, admitted at     the neonatology UMCG, born <30 weeks and/or birth weight < 1000 gram, who participate in     NeoLifeS Primary parameters: The occurrence of PH (Incidence and Prevalence).      Secondary parameters:        -  Maternal and neonatal patient characteristics that are potential risk factors for the          development of PH,        -  Morbidity-score (quality of life and hospital admissions) and mortality.   "
42464|NCT02729831|"     This study is a 2X2 factorial randomized trial that will the examine the comparative     effectiveness of two patient decision aids for hip and knee osteoarthritis as well as the     impact of a surgeon-focused intervention.   "
42465|NCT02729818|"     Microperimetry is a relatively new and extremely sensitive method of assessing visual     function. It projects light stimuli onto a defined area of the retina to map retinal     perceptual thresholds. Participants look at a focal point and press a button to indicate when     they have seen a light stimulus. The stimuli vary in intensity to find the participant's     visual sensitivity.      Microperimetry is carried out in low light conditions. Before testing, participants must     adapt to the low light conditions in a process called 'dark adaptation.' Currently there is     no consensus on the optimal time needed for dark adaptation. Investigators know that visual     sensitivity differs in differing light conditions. Failing to sufficiently dark-adapt may     therefore adversely affect test results.      The aim of this study is to establish the optimal length of dark adaptation for     microperimetry performance in healthy volunteers. On day 1, participants will undergo     training field tests to reduce a learning effect affecting the results. Tests will then be     performed following 5 mins adaptation, 10 mins adaptation and 30mins adaptation, On day 2,     participants will perform testing following no adaptation time, 15 mins adaptation, and 20     mins adaptation. Statistics will be used to determine the effect of adaptation time on     average threshold measures.   "
42476|NCT02729675|"     The purpose of this project is to study the efficacy of a delivery system to offer fresh     fruits and vegetables (F&V) at discount prices for purchase at worksites in conjunction with     educational interventions on increasing employees' F&V consumption in comparison to an     intervention receiving fruit and vegetable markets alone or a comparison intervention.   "
42477|NCT02729662|"     A longitudinal clinical study to investigate the changes before and after administration of     tolvaptan in patients whose clinical course is monitored prior to the approval of tolvaptan     will employ a method different from that used in the TEMPO study.   "
42676|NCT02727062|"     This research is being done to evaluate whether or not the Oral Mucositis (OM) Pain App (a     smartphone application) is a feasible and valid tool to assess pain from radiation sores     (also referred to as mucositis) when treating head and neck cancers with radiation. The     mobile app will be designed to help people better understand the pain from the radiation     sores.   "
42466|NCT02729805|"     Preventive analgesia is when an administered analgesic drug provides reduction in pain beyond     its duration of action. This can be used to reduce acute postoperative pain and prevent     occurrence of chronic post-surgical pain.      According to the International Association for the Study of Pain (IASP), chronic pain can be     defined as pain that persisted beyond the time of normal tissue healing (usually 3 months)     and that was not related to other causes. Mastectomy is associated with a high incidence of     chronic post-surgical pain. Breast cancer is the most common malignancy affecting females     around the world. Many undergo mastectomy as part of curative treatment. However, a     significant proportion of patients experience chronic post-surgical pain. This results in     significant negative impact on physical, psychological and social wellbeing.      Ketamine is an intravenous anaesthetic drug with analgesic effects. It can be used to treat     both acute and chronic pain. A recent meta-analysis of different surgeries showed that     patients receiving ketamine had a modest but statistically significant reduction in incidence     of chronic post-surgical pain. In a small sample single dose pilot study, patients given low     dose intravenous ketamine intraoperatively had a statistically non-significant reduction in     incidence of pain around the surgical scar at three months after radical mastectomy.     Randomized control trials with larger sample sizes are needed to determine the effectiveness     and optimal dosing regime of ketamine for reduction of chronic post-mastectomy pain. It is     therefore hypothesized that intravenous ketamine given intraoperatively will reduce the     incidence and severity of chronic pain after modified radical mastectomy. A double blind     randomized controlled trial comparing placebo group with two different doses of ketamine is     proposed.      The mechanism of action of ketamine in reducing pain is complex and multiple. How ketamine     can prevent and reduce chronic pain is unknown. Ketamine has been shown to reduce immediate     gene expression at site of mechanical injury. Transient Receptor Potential Vanilloid 1     (TRPV1) and Transient Receptor Ankyrin 1 (TRPA1) are receptors shown to mediate acute and     chronic pain. Ketamine, shown to affect gene expression, may alter the expression of TRPV1     and TRPA1 via epigenetic mechanisms.   "
42467|NCT02729792|"     Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment for medically     refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical     neurons using externally applied, powerful, focused magnetic field pulses. Dozens of studies     and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral     prefrontal cortex (DLPFC) produces statistically significant improvements in MDD, even when     medications have failed. However, other possible targets may also yield improvement in     symptoms.      In an attempt to enhance the therapeutic efficacy of current interventions for TRD, attention     has turned to identifying domain-specific biomarkers in hopes of ultimately individualizing     and predicting treatment response. Unfortunately, the precise nature of this relationship is     less than clear, as reflected by the fact that even now there are no established biomarkers     that are used routinely in clinical practice to aid in diagnosis. This study also seeks to     examine a comprehensive suite of biomarker measurements (MRI, neurophysiology, and     genomics/proteomics) before and after rTMS treatment.   "
42468|NCT02729779|"     Chronic low back pain is potentially disabling for the elderly, and physical exercises are     considered the best treatment for this problem. The Pilates method has been proven effective     in the improvement of pain and function in patients with low back pain. However, the evidence     about the effectiveness of Pilates method in the treatment of elderly patients with low back     pain is scarce. Thus, the aim of this study is to investigate the effectiveness of the     Pilates method compared to aerobic exercise in elderly with chronic non-specific low back     pain. This randomized controlled trial with two arms and blinded assessor will include 74     patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific low     back pain persisting for more than three months and pain intensity greater than 3 points in     the Pain Numerical Rating Scale. The elderly will be randomized into two groups: Pilates     Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with     aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week     with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity and     general disability assessed eight weeks after randomization. Secondary outcomes will be: pain     intensity and general disability evaluated six months after randomization; global impression     of improvement, specific disability and dynamic balance, muscle strength of the gluteus     maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight     weeks and six months after randomization. We expect that the results of this study contribute     to the clinical decision-making with respect to pain reduction and, consequently, improving     balance and functionality of elderly with chronic low back pain.   "
42469|NCT02729766|"     Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is a     new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is     expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered     glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent     osmotic diuresis. This mechanism could result in a therapeutic effect in patients with     hypotonic hyponatremia as in the syndrome of inappropriate antidiuretic hormone (ADH)     secretion (SIAD). Because patients with SIAD usually have several comorbidities and different     medications, studies investigating the physiological effects are difficult to interpret.     Therefore a model to study the possible physiological effect of SGLT2-inhibitors in hypotonic     hyponatremia as in SIAD is needed.      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on     serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.   "
42470|NCT02729753|"     This study will evaluate the CryoBalloon™ Full Ablation System for the ablation of human     esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to     the objective of the study   "
42471|NCT02729740|"     The primary objective of this study is to gather post market data on the Penumbra SMART Coil™     System in the treatment of intracranial aneurysms and other malformations.   "
42472|NCT02729727|"     To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the     ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy   "
42473|NCT02729714|"     The purpose of this study is to see if the study drug, suvorexant, is safe and effective in     treating symptoms of insomnia in people with Parkinson's Disease. It is anticipated that a     total of 20 subjects, 30 to 80 years of age, with Parkinson's Disease and symptoms of     insomnia will participate in the study at this site   "
42474|NCT02729701|"     The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated     by peri- and post-menopausal women at moderate risk for development of breast cancer.   "
42475|NCT02729688|"     Objective of this study are to compare the interface pressure by applying ordinary elastic     bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who     could apply the optimal pressure with OEB and CPG-EB.   "
42522|NCT02729077|"     This study investigates the incidence of postoperative respiratory complications (PRCs)     including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery,     and failure to wean from ventilator within 48 hours of surgery - in patients with and without     risk factors for OSA undergoing elective, non-cardiac surgery (NCS).   "
42479|NCT02729636|"     Functional electrical stimulation (FES) is multi-pad system that allows fast optimization of     stimulation patterns for achieving strong dorsiflexion/plantar flexion and automatic     real-time control of ankle joint during FES assisted walking. The main aim of the present     study is to compare the effects of functional electrical stimulation gait training after     stroke and overground conventional physical therapy. With the assumption that the advanced     method of functional electrical stimulation will improve gait parameters and functionality in     patients with foot drop before and after FES treatment the objectives of this study are to     examine the effects of functional electrical stimulation using FES:a method on indicators of     walk and function in patients with foot drop before and after FES treatment.   "
42480|NCT02729623|"     Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of     standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological     treatment for neuropathic pain. The objective of this study is to explore the     pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler,     (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating     dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg /     20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis Inhaler     device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events will be     monitored following the inhalation.   "
42481|NCT02729610|"     To investigate if bronchial blocker is more suitable for one-lung ventilation during     thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the     double-lumen endobronchial tube.   "
42482|NCT02729597|"     The natural history of brain affection in myotonic dystrophy types 1 and 2 is still unknown.     The investigators designed a 5-year longitudinal neuropsychological and neuroimaging     follow-up study to address this issue. Myotonic dystrophy type 1, myotonic dystrophy type 2     patients, and healthy controls were enrolled. All participants undergo clinical-neurological     examinations, neuropsychological analyses according to a 13-item neuropsychological test     battery, and 3T-brain MRI including voxel-based morphometry and diffusion tensor imaging at     baseline and at follow-up using identical examination protocols.   "
42483|NCT02729584|"     The study aims at evaluating in normal weight and obese subjects those factors such as taste     sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid     and energy metabolism in order to design personalized nutritional strategies.   "
42484|NCT02729571|"     Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage).     The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants,     randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose (5x10E05 CFU/0.1mL)     (n=9 in each group). Upon favourable safety review by the DSMB for all 18 adults up to day 28     after study vaccination, the second stage will commence in thirty-six (36) HIV unexposed, BCG     naïve, newborn infants, randomized 1:3 to receive BCG Vaccine SSI or MTBVAC at one of three     different dose levels ( (n=9 in each group).   "
42485|NCT02729558|"     Objective: To improve local control following complete resection of a single brain metastasis     using fractionated local stereotactic radiotherapy, whilst maintaining neurological     functioning, neurocognition and quality of life.      Study design: Multicenter randomized phase III, with at least three high-volume Dutch centers     participating in the trial. Stratification on primary tumor type and age.      Study population: Patients undergoing complete resection of a single brain metastasis,     confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan.      Study intervention: Patients will be randomized between observation alone (standard arm) and     local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study     arm).      Main study parameters: Primary objective: local control rate at 6 months. Secondary     objectives: local control rate at 12 months, neurological functioning, freedom from clinical     neurological progression, performance status, quality of life, toxicity, steroid use,     neurocognition and overall survival.   "
42486|NCT02729545|"     This study evaluates the efficacy and safety in improving ovarian function of polycystic     ovarian syndrome in adults. Half of patients will receive Dong's extra-point acupuncture     therapy, while the other half will receive Diane-35 as the control group.   "
42487|NCT02729532|"     A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study     the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB     diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic     cascade before starting TB treatment; and 4) loss to follow-up after initiation of TB     treatment.   "
42488|NCT02729519|"     Balloon predilatation of the aortic valve has been regarded as an essential step during the     transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested     that aortic valvuloplasty may be harmful and that high success rate may be obtained without     prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and     using new generation balloon expandable prothesis is associated with a better net clinical     benefit in comparison with procedure performed with pre dilatation.   "
42523|NCT02729064|"     Intranasal insulin is reported to improves memory performance in patients suffering from     cognitive impairment. The investigators have previously shown that intraoperative insulin     administration preserves both short and long-term memory function after cardiac surgery.     Applying intranasal insulin bypasses blood-brain barrier and cause elevation of insulin     concentrations in the cerebrospinal fluid without major effects on peripheral insulin level.     Patients undergoing major surgery are exposed to carbohydrate and insulin metabolism     alteration. The goal of the study is to study the effect of intranasal insulin on blood     glucose, plasma and cerebrospinal insulin concentration in patients undergoing cardiac     surgery or endovascular thoracic aneurysm repair.   "
42554|NCT02728661|"     PACE is a patient-centered weight loss program that was developed specifically for knee     replacements based on input from stakeholders, including knee replacement patients, physical     therapists, and orthopedic surgeons. In this pilot study, participants undergoing knee     replacement will be randomized to either start a weight loss program before surgery (PACE) or     after surgery (Delayed PACE). Both programs will receive a 14-week intervention and complete     assessments at baseline (up to 6 weeks prior to surgery), 12 weeks after surgery, and 26     weeks after surgery.   "
42489|NCT02729506|"     Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common     malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new     patients a year. The intermediate stage of HCC is controlled by radiological interventions     such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y     radioembolization is increasingly being used in clinical practice, there is no high quality     clinical evidence to justify this. To date, no prospective studies have been performed     comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized     controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients     with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients     in each arm from. Investigators will compare between the two groups the time to progression     (TTP) as the primary outcome and also examine time to local progression (TLP) as well as     other factors like overall survival, response to therapy, toxicities and adverse events,     quality of life and treatment-related costs.   "
42490|NCT02729493|"     This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or     refractory liver cancer with an infusion of the patient's own T cells that have been     genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour     cells that express the EPCAM protein on the cell surface.The study will determine if these     modified T cells help the body's immune system eliminate tumour cells.The trial will also     study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and     the impact of this treatment on survival.   "
42491|NCT02729480|"     The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation     for the treatment of neuropathic pain.   "
42492|NCT02729467|"     The purpose of this study is to assess the effects of itraconazole, a strong cytochrome P     (CYP)3A4 and p-glycoprotein (PgP) inhibitor, and rifampicin, a CYP3A4, uridine     5'-diphospho-glucuronosyltransferase (UGT), and PgP inducer, and an inhibitor of organic     anion-transporting polypeptide (OATP), on the single-dose pharmacokinetics (PK) of     JNJ-53718678 in healthy adult participants.   "
42493|NCT02729454|"     Introduction Although drug therapy is the mainstay of treatment for Parkinson's disease, the     therapy also has its importance by means of exercises which maintains the muscular activity     and preserve mobility. One of the techniques that has been used for physical therapy is the     mental practice of the mental simulation of movement, aiming at learning or improvement of     motor skills through the cortex areas of activation responsible for the movement of     preparation before it is executed. In patients with Parkinson's disease motor anticipation     this system is compromised, culminating in the march changes and increased risk of falls.     Objective: To evaluate the effects of mental practice on physical therapy on the march and     the risk of falls in people with Parkinson's disease. Method: The study is defined as a     randomized clinical trial with systematic recruitment. Recruitment will be conducted at the     Clinic of Neurology, Hospital das clinics Federal University of Pernambuco (Pro-Parkinson     Project: Neurology) and the intervention will be held at the same hospital physiotherapy     clinic. Both the control group and the trial will be subjected to 15 therapy sessions twice a     week, lasting 40 minutes for physical therapy and 15 for mental practice.   "
42494|NCT02729441|"     The investigators conducted a single center study controlled study involving 20 patients with     Type 2 Diabetes and hypertension who were randomly assigned to receive ramipril 10mg or     perindopril 8mg. The primary endpoint was difference in urine albumin-creatinine ratio at     night time and during the day. Secondary endpoint was measurement of blood pressure.   "
42495|NCT02729428|"     The overall goal of observational study is to examine the age-related and habitual exercise     training status-related differences in structural and functional changes in the human brain,     detected by magnetic resonance (MR) imaging.   "
42496|NCT02729415|"     Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of     Caucasian men and women, respectively, over the age of 50. The percentage of men and women     affected over the age of 70 increases to 80% and 60% of Caucasian men and women,     respectively. Although alopecia is considered a minor dermatologic condition, it is seen as a     serious condition with major life consequences by those with alopecia and has been associated     with increased incidence of myocardial infarction, hypertension and hypercholesterolaemia.     Androgenetic alopecia is associated with feelings of anxiety, depression and various     personality disorders among men and women due to physical appearance. Depression, anxiety,     aggressiveness, impaired quality of life and social inadequacy have been documented. The     presence of alopecia in women is particularly stressful.      ADSCs (Adipose Derived Stromal Cells), also called Stromal Vascular Fraction (SVF) cells,     include regenerative cell populations derived from adipose tissue and thus are potentially     important to multiple disease processes and therapeutic applications for the repair and     regeneration of acute and chronically damaged tissues. It has been postulated that SVF cells     may promote hair regeneration by increasing the hair-inducing ability of dermal papillae (DP)     cells.      The general objective of this study is to conduct a safety and feasibility study of a single     injection of autologous adipose-derived SVF cells for the treatment of alopecia.   "
42497|NCT02729402|"     The subjects will be age 65 years and older, with no upper limit of age range with hearing     loss that are candidates for standard-of-care cochlear implant.      Cognitive tests will be administered preoperative, and postoperative at 6 and 12 month     intervals.   "
42498|NCT02729389|"     The purpose of this research study is to investigate how social standing in a game of     Monopoly may influence behavior.   "
42499|NCT02729376|"     This is an open label, single dose, 1 period study of [14C] galeterone.   "
42537|NCT02728882|"     This single-arm, multicenter Phase 2 study will treat the patients who have Recurrent or     refractory diffuse large B cell lymphoma with an infusion of the patient's own T cells that     have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to     tumour cells that express the EPCAM protein on the cell surface.The study will determine if     these modified T cells help the body's immune system eliminate tumour cells.The trial will     also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body     and the impact of this treatment on survival.   "
42701|NCT02726737|"     The purpose of this prospective, randomized, double blind study was to evaluate the effect of     a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior     alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic   "
42500|NCT02729363|"     Our goal is to improve the self-management of pain and stress in adult outpatients with     sickle cell disease (SCD) by determining the feasibility of a self-managed guided relaxation     (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid     analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such     as GR, are rarely used. Little is known about the effects or mechanisms of GR on pain and     stress, in adults with SCD. Emerging evidence from the hypothalamic pituitary adrenal (HPA)     axis theory offer insights for understanding the mechanisms. Adding GR as a supplement to     analgesic therapies will address the paucity of self-management strategies for controlling     pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain     and stress in outpatients with SCD. GR is an intervention where outpatients with SCD are     directed to listen to and view audio-visual recordings while they visualize themselves being     immersed in that scene.   "
42501|NCT02729350|"     The goal of this research study is to improve the self-management of pain, stress, and     cognitive/affective symptoms that may result in adult inpatients with sickle cell disease     (SCD) by determining the feasibility of a self-management guided relaxation (GR) stress     reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are     primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are     rarely used, particularly, in inpatient settings. Little is known about the effects or     mechanisms of GR on pain, stress, and cognitive/affective symptoms in adults with SCD     hospitalized with pain. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis     theory offer insights for understanding the mechanisms. Adding GR as a supplement to     analgesic therapies will address the dearth of self-management strategies for controlling     pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain     and stress in inpatients with SCD. GR is an intervention where inpatients with SCD are     directed to listen to and view audio-visual recordings while they visualize themselves being     immersed in that scenario.   "
42502|NCT02729337|"     The investigators propose to develop a comprehensive, text messaging-based HIV prevention     program for Ugandan adolescents 18-22 years of age.   "
42503|NCT02729324|"     Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC).     Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays,     radiation dermatitis is still common. It has an impact on pain and quality of life, and if     severe, may lead to interruption of the radiation schedule for the patient. Trolamine     (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for     preventing acute radiation-induced skin toxicity in China. However, as long as grade ≥2     radiation dermatitis is developed, trolamine is not allowed to use any more. Medical     Radiation Protectants (FORRAD®) is a new kind of topical agents for prevention and treatment     of radiation dermatitis. It could be used during the course of radiotherapy, even when grade     ≥2 dermatitis is developed. This randomized phase II study is aimed to assess the     effectiveness and safety of Medical Radiation Protectants (FORRAD®) for the prevention and     treatment of acute radiation-induced dermatitis of grade 3 or higher during IMRT for patients     with NPC, compared with trolamine.   "
42504|NCT02729311|"     Preventing Loss of Independence through Exercise (PLIÉ) is a unique, multimodal movement     program for people with dementia (affected individuals) that is taught by trained instructors     and combines physical, mental and social activities. The Paired PLIÉ Program is an adapted     version designed for pairs of affected individuals and care partners. The goal of this study     is to perform a randomized, controlled trial (RCT) with a delayed start design to examine the     effects of the Paired PLIÉ Program on function and quality of life in affected individuals     and care partners.   "
42505|NCT02729298|"     TP-0903 is a novel oral inhibitor that targets AXL kinase. Preclinical studies have shown     promising antitumor activity of TP-0903 as a single agent against a variety of tumor types in     both in vitro and in vivo studies.      This first-in-human study is conducted to identify the maximum tolerated dose (MTD) and     dose-limiting toxicities (DLTs) of TP-0903 administered orally to patients with advanced     solid tumors.      The study will investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary     anti-tumor activity profiles.   "
42506|NCT02729285|"     The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients.     Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar     anesthesia saves operative time and money compared to general analgesia, the intraoperative     pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been     demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy,     posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so     forth. The aim of the investigators study is to determine the safety and preemptive analgesic     effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under     retrobulbar anesthesia.   "
42507|NCT02729272|"     The aim of this randomized trial was to compare the degree of surgical smoke obstructing     vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in     colpotomy during total laparoscopic hysterectomy.   "
42509|NCT02729246|"     The main purpose of this project is to further explore the metabolic effects and the     mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. The     project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both     pre-diabetic as well as diabetic subjects with obesity will be included. This part of the     project focuses on patients with manifest T2D and they will be assigned to surgical and     non-surgical intervention, respectively, in a strictly controlled and randomized manner.   "
42553|NCT02728674|"     This is a web-based randomized survey to evaluate management of respiratory symptoms among     physicians in Sweden. The aim of this study is to determine if there is a gender bias in the     diagnosis of COPD and how often physicians identify that chronic refractory breathlessness     requires treatment as compared to refractory pain.   "
42743|NCT02726191|"     The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of     two novel computerized cognitive enhancing software packages for improving cognitive and     behavioral outcomes in patients with epilepsy.   "
43196|NCT02720263|"     The purpose of this study is to evaluate the safety and tolerability of multiple ascending     oral doses of ASP4345 in patients with schizophrenia. In addition, this study will evaluate     the pharmacokinetics of multiple ascending oral doses of ASP4345 in patients with     schizophrenia.   "
42510|NCT02729233|"     Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). UC is an     ongoing disease of the colon or large intestine. Studies have shown that leakiness of the gut     plays a major role in the development of UC. Leakiness of the gut is a condition that is a     result of damage to the intestinal lining, making it less able to protect its internal     environment as well as to filter needed nutrients and other substances. Some bacteria,     toxins, and waste not normally absorbed may get into the blood stream.      Golimumab is an FDA approved medication used for the treatment of moderate to severe     ulcerative colitis. The investigators have evidence to suggest that measuring the leakiness     of the gut using a tool called a confocal laser endomicroscope may be able to predict how     well a patient's body will respond to treatment of UC with golimumab. Confocal laser     endomicroscopy (CLE) is an FDA approved technique that can look at the cells of a patient's     gut during colonoscopy to assess the leakiness of gut.      The objective of this study is to determine how the leakiness of the gut in patients with UC     can predict response to golimumab therapy.   "
42511|NCT02729220|"     The purpose of this study is to find out if subjects with chronic obstructive pulmonary     disease have signs of accelerated ageing in their airways.   "
42512|NCT02729207|"     The safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in     comparing with placebo in the treatment of acute pain due to ankle sprain   "
42513|NCT02729194|"     Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular     endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which     are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA approved     for advanced renal cell carcinoma (RCC) with a clear cell component. Conventional Pazopanib     dosing WITHOUT FOOD is with an initial dose of 800 mg by mouth daily. Investigators     hypothesize that administration of pazopanib with low fat meal would be safe and feasible     with secondary implications of higher pazopanib levels; potentially translating into greater     anti-tumor efficacy in advanced renal cell cancer, with significant cost savings. In the     proposed pilot study, investigators seek to test the feasibility and practicality of this     approach and gather preliminary data on adverse effects and the safety profile. Investigators     hope to ameliorate any potential for greater toxicities with a dynamic dosing design that     incorporates adverse events from each cycle into dosing for the next cycle and a structured     symptom specific plan.   "
42514|NCT02729181|"     The investigators hypothesize that treatment with non-invasive spinal decompression reduces     discogenic low back pain (LBP), decreases visual analog pain scale scores, increases     activities of daily living and decreases medication use.   "
42515|NCT02729168|"     An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine     INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.   "
42516|NCT02729155|"     This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to     evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for     prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography     and angioplasty   "
42517|NCT02729142|"     The optimal management of calcium and phosphate metabolism regulation in chronic kidney     disease (CKD) is important in preventing fracture risk and vascular calcification and thus     morbidity and mortality, global and vascular.      Kidney transplant in a CKD context, usually with a pre-existing underlying renal     osteodystrophy, malnutrition, chronic inflammation, hypogonadism and immunosuppression     protocols still often made up of high-dose corticosteroid therapy, are all theoretical     factors of post-transplantation bone disease. For other solid organ transplants, even though     there is generally no underlying renal osteodystrophy before the transplant, the proportion     of osteoporotic patients at the time of transplant is substantial. The bone risk in the     immediate post-transplant period is notable.      Patients' follow-up is based on biological, radiological and histological tools. Bone     densitometry (DXA) is used to measure bone mass. However, recent international     recommendations do not consider DXA as a valid tool to assess bone health in CKD patients.     Moreover, it is less informative than peripheral quantitative tomography resolution     (HR-pQCT). This latest technique, available in Lyon and Saint-Etienne, is more precise,     allowing a three-dimensional study of the trabecular microarchitecture and compartmental     volumetric bone density (total, cortical, trabecular), while similar to DXA in terms of     radiation (less than 5 μSv). The prevention of cardiovascular risk factors is also part of     the daily care of patients with a regular cardiac monitoring (heart ultrasound) and vascular     (blood pressure, Doppler of the supra-aortic trunks).      TRANSOS study aims to evaluate in a prospective cohort (longitudinal follow-up of 6 months),     the bone status in patients receiving solid organ transplantation in the University Hospitals     of Lyon and Saint-Etienne, using DXA and HR-pQCT (at baseline and month 6), in combination     with classical biological and cardiovascular monitoring. Transplantation is an important     activity in these two hospitals and this protocol provides the same bone follow-up for all     solid organ transplants, with a reliable, efficient, non-invasive and low-dose radiation     tool.      The primary objective of TRANSOS study is to evaluate changes in tibial cortical density     between the baseline and the 6th month post-transplant measured by HR-pQCT.   "
42518|NCT02729129|"     Air pollution exposure is a major environmental and public health concern. The findings from     controlled exposure studies have given biological plausibility to the epidemiological     associations, and have defined important pathways that may be amenable to intervention.     Ultimately, there is a need to address how one may protect the public from these detrimental     effects. Two studies have been performed assessing the cardiovascular effects of wearing a     face mask in a highly polluted urban area in China in healthy volunteers and patients with     coronary heart disease. These demonstrated lower blood pressure and increased heart rate     variability when wearing a face mask as compared to not. The investigators aim to test if     wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the     well-known adverse cardiovascular effects.   "
42519|NCT02729116|"     This study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute     urinary tract infection caused by Extended Spectrum Beta Lactamase producing Escherichia coli     or Klebsiella pneumoniae in Post-kidney transplantation. Patients are treated with     intravenous (IV) antibiotics follow by oral sitafloxacin or IV ertapenem.   "
42520|NCT02729103|"     This study will evaluate treatment patterns, mortality, healthcare resource utilization, and     costs in patients with prostate cancer with bone metastases (primary objectives).     Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this     patient population (secondary objective). The study is descriptive in nature and is meant to     provide a greater understanding of the patterns of therapy observed in real-world clinical     practice (in the absence of clear guideline recommendations with regards to treatment     sequencing), to contribute to a greater understanding of the major cost drivers (thus     better-informing payers), and to examine real-world mortality in such patients.   "
42521|NCT02729090|"     The Peripheral Arterial Disease prevalence is around 3-10 % of the world population. Exercise     plays an important role in treating these patients.   "
42524|NCT02729051|"     This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus     UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized,     double-blind, parallel group multicenter study. This study will test the hypothesis that the     difference in trough forced expiratory volume in one second (FEV1) between treatment groups     is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study     will also test the hypothesis that the difference between treatment groups is greater than     the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the     aim of providing a new treatment option for the management of advanced Global Initiative for     Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation     frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung     function, health related quality of life (HRQoL) and symptom control over established     dual/monotherapies. This study has a 2 week run in period where subjects will continue to     have their existing COPD medications. At randomization, subjects will discontinue all     existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram     (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio     for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit     1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit     5). A follow-up visit will be conducted at 1 week after the end of treatment period or after     early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There     will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects     will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The     total duration of subject participation will be approximately 27 weeks, consisting of a     2-week run-in period, 24-week treatment period and a 1-week follow-up period.   "
42525|NCT02729038|"     This study will be conducted to determine if altered renal function affects the plasma     pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal     impairment are required. The objective of this study is to compare the pharmacokinetics of     gepotidacin administered as a 750 milligram (mg) intravenous (IV) dose in normal healthy     subjects compared with subjects with mild, moderate, and severe renal impairment, and with     subjects with end stage renal disease (ESRD). This is a Phase I, nonrandomized, open-label,     parallel-group, multi-center, multi-part study. In Part 1, up to 16 subjects with normal     renal function will be matched to approximately 8 subjects with moderate renal impairment,     and approximately 8 subjects with severe renal impairment and/or subjects with ESRD not on     hemodialysis for a total of approximately 32 subjects. In Part 2 (optional), approximately 4     to 8 subjects with normal renal function (if enrolled), approximately 4 to 8 subjects with     mild renal impairment, and approximately 4 to 8 subjects with ESRD on hemodialysis will be     enrolled for a total of approximately 12 to 24 subjects. The duration from Screening to the     Follow-up Visit will be approximately 44 days for Part 1 and approximately 50 days for Part     2.   "
42526|NCT02729025|"     A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9)     inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).   "
42527|NCT02729012|"     The main objective of RinASol project is to assess in patients with seasonal Allergic     Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard     saline solution on nasal inflammation by means of nasal cytology.      The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom     Score 5)   "
42528|NCT02728999|"     Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign,     robotic-assisted gynecologic procedures at Lutheran General Hospital.      Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep     Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which     is 30 degrees.      Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and     the difference in Trendelenburg between the two arms. Additional outcomes included will be     end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and     arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and     conversion to laparotomy.   "
42529|NCT02728986|"     The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management     when two different compression systems are used.   "
42530|NCT02728973|"     Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark,     this is a new concept for the integration of the latest study of the surgical, anesthesia,     and nursing. The purpose of optimization measures, reduce patient trauma stress, promote     early rehabilitation of patients. The investigators plan to compare the feasibility, clinical     effectiveness, and cost savings of an ERAS program with traditional treatment program at a     major teaching hospital in China.The investigators will apply ERAS plan or traditional     treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively.     And data Compare the two programs about the incidence of postoperative complications,     postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.   "
42531|NCT02728960|"     The primary purpose of this study is to validate the High Definition Fiber Tracking     (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in     Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and     normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to     develop a statistically sound range for the metrics derived from HDFT.   "
42532|NCT02728947|"     To study the profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in     patients with early-stage Parkinson's disease   "
42533|NCT02728934|"     The purpose of this study is to compare the proportion of patients with an infusion reaction     in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.   "
42534|NCT02728921|"     To study if plasma volume expansion is influenced by the rate at which a colloidal solution     is administered in patients with a systemic inflammatory response induced by major abdominal     surgery.      Randomization will be performed postoperatively at the day of surgery with a 1:1 ratio with     no stratification and the study drug will be given as a slow (3 hours) or rapid (30 minutes)     intravenous infusion.   "
42535|NCT02728908|"     An open study evaluating the diagnostic accuracy of a microwave-based device to detect     traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with     confirmed vs excluded TICH   "
42536|NCT02728895|"     The purpose of this study is to assess the initial tolerability, safety and recommended phase     2 dose of vedolizumab intravenous (IV) administered for Graft-Versus-Host Disease (GvHD)     prophylaxis along with standard GvHD prophylaxis therapy (in participants undergoing     allogeneic hematopoietic stem cell transplantation [allo-HSCT]).   "
42582|NCT02728297|"     Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of     palmo-axillo-plantar hyperhidrosis   "
42538|NCT02728869|"     Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in     children aged less than 5 years worldwide and are reported to infect nearly every child by     the age of 5 years. About 90% of all rotavirus-associated fatalities occur in low income     countries in Africa and Asia and are related to poor health care. In view of high global RVGE     burden, the World Health Organization (WHO) on 5th June 2009, recommended the inclusion of     rotavirus vaccine in all the national immunization programs.      Currently available rotavirus vaccines, RotaTeq® and Rotarix®, are WHO prequalified vaccines     which are stable for recommended duration at storage temperature between 2-8 °C. However, if     these vaccine are exposed to temperatures above 30 °C, the vaccine has to be discarded due to     lost potency. It is very difficult to maintain the cold chain required to conserve the     vaccine potency particularly in developing and low income countries, resulting in large     amount of vaccine being wasted and in worst case scenario, endangering the lives of potential     recipients. The WHO estimates that nearly half of freeze-dried and quarter of liquid vaccines     are wasted each year. One of the biggest contributors to this wastage is disruption of the     cold chain systems.      Hilleman Labs new Rotavirus vaccine is a lyophilized heat stable rotavirus vaccine comprising     of five live attenuated reassortant rotaviruses similar to RotaTeq®. The new heat stable     rotavirus vaccine (HSRV) formulation offers a stability profile of 9 months at 45 °C and 12     months at 37 °C. This new heat stable formulation (HSRV) could be transported in     non-refrigerated supply chain significantly reducing the cost and complications associated     with transporting vaccine to remote corners of the developing world. Heat-stable rotavirus     vaccine (HSRV) has a potential to sustain high temperatures frequently encountered in regions     where majority of rotavirus burden exists and has potential to partially or completely     eliminate cold chain dependence.      The current study has been designed to test for the first time in humans, the safety and     tolerability of the new heat stable rotavirus vaccine (HSRV) in adults; followed by safety     and immunogenicity in infants of age 6-8 weeks, as compared to the licensed RotaTeq® vaccine.   "
42539|NCT02728856|"     To evaluate the human eye irritation potential of two test sunscreen formulation   "
42540|NCT02728843|"     The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in     patients with Parkinson's disease. Participants will be randomized to receive one of four     different dosages of deferiprone or placebo, and will take the assigned study product twice a     day for nine months.   "
42541|NCT02728830|"     The ultimate goal of the study is to identify potential biomarkers, immune gene expression     signatures, and co-stimulatory pathways that may be used to understand the effect of immune     checkpoint inhibitors on gynecologic cancers.   "
42542|NCT02728817|"     The Radial Artery Deviation And Reimplantation (RADAR) technique is a new approach for the     construction of hemodialysis arteriovenous fistula. In this technique, the radial artery     pedicle is deviated towards the minimally dissected cephalic vein at the wrist. The aim of     this study is to compare the safety and efficacy of this technique with the traditional     end-cephalic to side-radial arteriovenous fistula, currently used as a first line vascular     access in hemodialysis patients.      The hypothesis is that the minimal dissection concept used in the RADAR inhibits venous     juxta-anastomotic neointimal hyperplasia and stenosis, and lead to higher rates of maturation     and patency.   "
42543|NCT02728804|"     This clinical trial studies the use of the financial impact assessment tool in patients with     colorectal cancer that has spread from the primary site to other places in the body.     Gathering information about patients with colorectal cancer over time may help doctors better     understand the financial impact of cancer and help patients avoid financial problems during     treatment.   "
42544|NCT02728791|"     Correlation study between the data provided by two measurement systems, trans- pulmonary     thermodilution and ClearSight © (non invasive), to determine the interest in routine use     (cardiac output, cardiac index, stroke volume and blood pressure).   "
42545|NCT02728778|"     The main objective of the trial is to test whether a single application of botulinum toxin A     into the glabellar region will lead to emotional stabilization in borderline personality     disorder through paralysis of facial muscles/attenuation of negative emotions.   "
42546|NCT02728765|"     To study the frequency of obstructive sleep apnea (OSA) and continuous positive airway     pressure (CPAP) treatment response in patients with non-alcoholic fatty liver disease     (NAFLD).      It is hypothesized that CPAP treatment may improve the activities of NAFLD in those with     concomitant OSA.      A screening study for OSA followed by a randomized controlled trial of patients with biopsy     proven NAFLD being followed up at the hepatology clinic.      Home sleep study, Epworth sleepiness score (ESS), paired proton magnetic resonance     spectroscopy (MRS), transient elastography by fibroscan, serum cytokeratin-18 fragment, liver     function tests and liver biopsy (only for those with fibroscan evidence of advanced liver     fibrosis).      Patients with confirmed symptomatic OSA will be randomized to receive auto CPAP or     subtherapeutic CPAP as control over 6 months.      Primary outcome: changes in intrahepatic triglyceride content (IHTG) measured by proton-MRS     after 6 months of auto CPAP versus subtherapeutic CPAP.   "
42548|NCT02728739|"     The purpose of this study is to determine the prevalence of moderate-to-severe Mitral     Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.   "
42549|NCT02728726|"     The study is designed to determine whether patients who receive sugammadex immediately after     tracheal extubation will exhibit a decrease in the incidence of postoperative residual     paralysis and an associated decrease in the incidence of postoperative respiratory     depression.   "
42550|NCT02728713|"     The purpose of this study is to determine if there is a measurable change in visual function     as a direct result of the application of osteopathic cranial manipulative medicine. The study     will also attempt to determine whether any changes noted remain after withdrawal of the     treatment.   "
42551|NCT02728700|"     This pilot phase I/II trial studies the side effects and how well sirolimus and mycophenolate     mofetil work in preventing graft versus host disease (GvHD) in patients with hematologic     malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological therapies, such     as sirolimus and mycophenolate mofetil, use substances made from living organisms that may     stimulate or suppress the immune system in different ways and stop tumor cells from growing.     Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell transplant may be     better in preventing graft-versus-host disease.   "
42552|NCT02728687|"     Treatments for painful diabetic peripheral neuropathy (PDPN) are not very effective and have     multiple side effects. To find out if a menthol cream alone or with added mannitol treats     PDPN effectively, 90 participants with PDPN, after one month of observation, will receive     randomly assigned menthol cream or the same cream with mannitol added for 3 months with a     crossover for 3 additional months. At time 0, 1,4 and 7 months their BPI pain severity and     interference scores, DN4 scores, cream % effectiveness and side effects will be compared.   "
43248|NCT02719587|"     The investigators primary objective in this clinical intervention study, therefore, was to     explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary     markers (in patients with chronic periodontitis.   "
42555|NCT02728648|"     Oxycodone has been in clinical use for decades. It is an effective alternative to morphine     for moderate to severe acute or chronic pain and has been found to improve quality of life.     The drug has been used parenterally or orally as perioperative analgesia or for cancer pain     relief (Kalso 2005). Despite of its long clinical experience, prescribing errors and misuse     may lead to addiction and accidental overdose (Berling et al. 2013, Boyle and Dosenbaum     2014). Currently, little is known about the pharmacokinetic properties of intravenous     oxycodone among paediatric patients in this region even though the drug has been used in     children in other countries such as Finland. Therefore, a pharmacokinetic-pharmacodynamic     study of oxycodone among Malaysian pediatric patients is warranted.   "
42556|NCT02728635|"     The purpose of this study is to collect data to help researchers better understand the     different ways that women or men store fat (apple shape versus pear shape).   "
42557|NCT02728622|"     A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer     resistant or refractory to platinum and taxane.   "
42558|NCT02728609|"     The purpose of this study is to compare the pro-inflammatory and anti-inflammatory cytokines,     protein content, and white blood cell (WBC) count present in the peritoneal fluid and plasma     of trauma patients who undergo one of two different methods of open abdominal closure.     Following analysis of the peritoneal fluid and serum samples, comparison of the results     between the two groups will be completed and correlated with the overall organ function.   "
42559|NCT02728596|"     This randomized clinical trial studies prophylactic colony stimulating factor management in     patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and     with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop     febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low number     of neutrophils (a type of white blood cell) in the blood. Febrile neutropenia increases the     risk of infection. Colony stimulating factors are medications sometimes given to patients     receiving chemotherapy to prevent febrile neutropenia. Colony stimulating factors are given     to patients based on guidelines. Some clinics have an automated system that helps doctors     decide when to prescribe them when there is a high risk of developing febrile neutropenia.     Gathering information about the use of an automated system to prescribe prophylactic colony     stimulating factor may help doctors use colony stimulating factor when it is needed.   "
42560|NCT02728583|"     The main aim of the study is to investigate the effect of daily consumption of a margarine     enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.      The study also aims to investigate the effect of plant sterols and fish oil on fasting total     cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein     cholesterol (HDL-C) and non-HDL-C.      At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations     will be explored.   "
42561|NCT02728570|"     The investigators have hypothesized that dietary flavonoids reduce insulin resistance and     subclinical inflammation secondary to reductions in intestinal inflammation and permeability     and that these events are mediated through alterations in gut microbiota composition. To test     this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets     that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53%     en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High     Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6     weeks each in a randomized cross-over design with endpoints determined in duplicate during     the last week of each diet period.   "
42562|NCT02728557|"     This study will assign patients to two types of psychotherapies in treating people with a     major depression disorder, expressive versus supportive techniques, and will examine their     ability to benefit from treatment based on their attachment orientation. This is a four month     protocol, with a year follow up period, will compare patients receiving supportive-expressive     treatment with either expressive focus or supportive focus.   "
42563|NCT02728544|"     Post exercise irisin levels in PWS patients Obesity, short stature, hypogonadism, hypotonia     and impaired cognition are the major clinical features of Prader-Willi syndrome (PWS), a     complex neurogenetic disorder due to lack of expression of paternal genes in the chromosomal     region 15q11-13. Abnormal body composition with decreased muscle mass and increased fat mass     contributes to low resting energy expenditure in PWS. Severe caloric restriction in the range     of 800 kcal per day along with daily exercise regimens are needed to prevent weight gain and     complications of obesity in this population.      Brown adipose tissue (BAT) once thought to be present only in infants, but now known to be     present in adults as well, differs from the more abundant white adipose tissue (WAT) by     dissipating energy through thermogenesis as a result of increased activity of the     mitochondrial uncoupling protein (UCP-1). Recently evidence shows that exercise activates     mitochondrial UCP-1 in subcutaneous WAT cells resulting in conversion of WAT to BAT-like     adipocytes (Beige or BRITE adipose tissue). Various factors including natriuretic peptides,     interleukin-6 and myokines (irisin, fibroblast growth factor 21, and ß-aminoisobutyric acid)     appear to mediate the effects of exercising muscle on subcutaneous adipocytes.      Decreased amount and/or activity of BAT might contribute to the lower energy expenditure and     extreme difficulty in weight-control in PWS. Lower levels or decreased myokine production     could result in failure to convert subcutaneous WAT to Beige or BAT-like adipocytes, and     therefore minimize or negate the otherwise beneficial metabolic effects of exercise. Direct     measurement of peak oxygen uptake in PWS adults show that this population has markedly lower     VO2 values compared with normal BMI-matched controls. BAT activity in vivo can be accurately     measured only by performing PET/CT scans which include administrating radioactive tracers.     For ethical reasons, direct assessment of BAT is not possible for purposes of clinical     research in PWS individuals.      The investigators propose to study humoral responses to exercise in 16 (8 males) PWS     adolescents and young adults and compare results with responses in a similar number of sex,     age, and BMI-matched controls. At an initial one-hour meeting study participants will learn     to perform aerobic (treadmill) exercise and resistance training under the supervision of an     experienced exercise physiologist. Exercise intensity will be assessed by direct measurement     of VO2 max. On a different day, a blood sample will be drawn before and immediately at the     conclusion of the same exercise regimen. Blood samples will be assayed for irisin,     interleukin-6, atrial natriuretic peptide, FGF-21, in addition to glucose, growth hormone,     cortisol, norepinephrine, and lactate.      The investigators hypothesize that PWS participants will show weaker humoral responses to     similar exercise regimens compared to normal control subjects. Data showing lower levels of     myokines, such as irisin, following exercise in PWS might suggest that inadequate conversion     of WAT to BAT-like adipocytes in subcutaneous adipose tissue results in decreased     thermogenesis and abnormally low energy expenditure in this population. Potentially,     development of pharmacologic agents which mimic irisin or other myokines by activating UCP-1     and converting WAT to BAT-like adipocytes could offer a new approach to weight-control in PWS     individuals.   "
42564|NCT02728531|"     Given the established role of high dose cytarabine (HiDAC) combined with rituximab, along     with recent data showing the encouraging efficacy of bendamustine, the investigators seek to     integrate the synergistic effects of these medicines in alternating cycles as induction     therapy prior to autologous stem cell transplant (ASCT). Based on prior experience with     bendamustine and rituximab (BR) based induction therapy, the investigators seek to evaluate     the efficacy and safety of stem cell mobilization in this pilot study   "
42565|NCT02728518|"     The investigator's goal in this study is to evaluate the efficacy and safety of nebulized     amikacin versus intravenous amikacin in patients with hospital and ventilator acquired     pneumonia in surgical patients admitted to the intensive care units infected with gram     negative bacilli   "
42566|NCT02728505|"     Single-center, prospective, placebo controlled trial of tolerability and safety of     low-concentration SinuSurf sinus irrigation solution in normal subjects. Forty (40) healthy     subjects aged 18-65 will be enrolled in the study.   "
42567|NCT02728492|"     Quisinostat besides its own efficacy, which can potentially lead to better results of     polychemotherapy and increase the mean time to progression, it may be demonstrated that     Quisinostat leads to sustained tumor sensitivity to platinum drugs. In this study safety and     tolerability of multiple administrations of Quisinostat in doses ranging from 8 mg to 12 mg     combined with standard backbone chemotherapy in patients with non-small cell lung cancer     (second line) and ovarian cancer (second and subsequent lines) will be investigated.   "
42568|NCT02728479|"     Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating     blood vessels in the treatment of peripheral artery disease.      The aim of this registry is to collect prospectively and systematically clinical research     data from patients undergoing PTA. This registry is an open-end observational study to assess     the characteristics and outcomes in patients with undergoing PTA.   "
42702|NCT02726724|"     The Endotracheal intubation (ETI) of a neonate is a procedure that usually attracts a large     number of observers. The fear of being judged by others could cause an increased level of     stress, especially on the junior trainees. Little research has focused on the effect of the     audience on the level of stress and therefore, on the success rate of complicated procedures     in neonatal intensive care.      Hypothesis:Investigators hypothesize that time to successful intubation (in seconds) will be     longer with the presence of observers.   "
42569|NCT02728466|"     There is a question regarding the role of higher flavanol oligomers (procyanidins) and of     intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol     intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are     absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are     not absorbed and are catabolized by the colonic microflora. The catabolites enter the     circulation. Phenolic acids and valerolactones represent a significant proportion of these     catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular     effects of these colonic microbiome-derived flavanol derivatives have not been studied so     far. The purpose of the study is to determine the timecourse of endothelial function along     with flavanol catabolites & metabolites during acute, sustained, and acute on sustained     ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol     free control.   "
42570|NCT02728453|"     Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk     secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not     addressed by currently available treatments. The abnormality results from obesity-induced     volume overload, increased blood pressure, and myocardial fat accumulation. By improving     metabolism, body weight, and blood pressure, Empagliflozin addresses the root causes of type     2 diabetes-associated myocardial disease. We will assess left ventricular mass, function, and     lipid content in patients with type 2 diabetes mellitus using cardiac magnetic resonance     imaging and spectroscopy as well as echocardiography before and after empagliflozin or     glimepiride treatment. We expect to observe improvements in left ventricular mass, function,     and fat content with empagliflozin. The results of the study will help to position     empagliflozin as an antidiabetic agent with the added value of protecting the heart.   "
42571|NCT02728440|"     Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of     Patients with Idiopathic Hypogonadotropic Hypogonadism   "
42572|NCT02728427|"     Compared with traditional open proctectomy, laparoscopic surgery is associated with less     pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes     have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery     was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some     studies show that the rates of urinary tract infection, second catheterization, and urinary     symptom are lower with suprapubic catheterization (SPC) than with transurethral     catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage     removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.      Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC.     Therefore, investigators perform this prospective randomized trial to compare SPC using CVC     with TUC in laparoscopic surgery for rectal cancer.   "
42573|NCT02728414|"     The purpose of this study is to determine whether the probiotics is effective in the     treatment of type 2 diabetes.   "
42574|NCT02728401|"     The aim of this investigation is to longitudinally quantify host gene expression and serum     proteins in children with infectious and non-infectious SIRS. The investigators hypothesize     that children with non-infectious SIRS, with bacterial infection associated SIRS, or with     viral infection associated SIRS will exhibit distinct patterns of host gene expression and     serum proteins. The investigators further hypothesize that it should be possible to discover     sets of mRNA or protein biomarkers that will permit unambiguous diagnosis of non-infectious     SIRS, SIRS associated with bacterial infection, and SIRS associated with viral infection.   "
42575|NCT02728388|"     The investigators wish to determine the time to disease progression for benign neurofibromas     treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy     (PDT) in patients with neurofibromatosis type 1 (NF1).      The investigators also wish to measure tumor size for control and treatment tumors in order     to gain insights into tumor growth rates.   "
42576|NCT02728375|"     This research project focuses on the evaluation of an engaging exercise and cognitive     computer game-based platform and embedded assessment tools for use in clinical practice and     its transition to use in the home, and elementary classrooms. The goal of our research     program is to produce innovative therapeutic point-of-care and cost-effective delivery system     leading to better long-term health outcomes for toddlers and children with neurodevelopmental     disabilities. The program is grounded on our technological developments and on current     research documenting the benefits of computer-aided learning tools, exercise gaming     applications in rehabilitation and principles of adaptive learning and neuroplasticity. We     will conduct a randomized controlled trial to study the feasibility and effectiveness of a     computer-aided, game-based repetitive task practice (RTP) program designed for training of     fine and gross motor skills of the hand-arms and psychomotor skills (which) in young children     with CP.   "
42577|NCT02728362|"     To investigate the functional outcomes and prevalence and severity of knee pain for patients     undergoing suprapatellar nailing of tibial shaft fractures.   "
42578|NCT02728349|"     The purpose of this study:      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics     characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the     advanced Glioblastoma Patients ;   "
42579|NCT02728336|"     The goals of this project are to: 1) explore the potential use of magnetic resonance imaging     (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2) use     the MRI-derived data together with a computer model of the cardiovascular system to study the     relative roles of different factors in the mechanical effects of dyssynchrony in failure, and     in the response (or lack thereof) to CRT.   "
42580|NCT02728323|"     In many countries, caesarean section (CS) rates have been increasing. The international     literature is unclear regarding the analgesic efficacy of the transversus abdominis plane     block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method     of performing this block has been matched with the obtained analgesic effect after a CS. The     primary goal of the study was to determine whether a correctly performed ultrasound-guided     TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute     postoperative pain during the first 72 hours after surgery   "
42581|NCT02728310|"     The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration     (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization     through an additive or synergistic effect because it can maintain continuous inhibition of     nociceptive afferents   "
42583|NCT02728284|"     The purpose of this investigation is to evaluate newer methods of performing cardiovascular     MRI (CMR) that will provide new kinds of information related to the interplay between the     cardiac and the respiratory cycles, such as the interaction between the left ventricle and     the right ventricle during respiration . The primary statistical objective is to provide     preliminary indications of the relative utility of the investigational imaging software in     terms of image quality and suitability for routine clinical use. Image quality will be     expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and     subjective Likert-type qualitative assessments independently provided by each of multiple     blinded readers for each image. Suitability for routine use will be assessed in terms of     imaging time and a binary indicator of whether, in the opinion of the investigator, adverse     procedural complications (not expected) were encountered during a given imaging session.   "
42584|NCT02728271|"     Churg-Strauss syndrome is a rare autoimmune inflammatory disease affecting medium- and     small-sized blood vessels, causing asthma, abnormalities of the blood, lung diseases, and     neuropathy. The main cause of death in these patients is heart attack. Without therapy, the     5-year survival in patients with Churg-Strauss syndrome is 25%. Although with the 5-year     survival is increased to 62% with the appropriate therapy, many patients remain refractory to     therapy. The long term outcome of these patients remains grim.      The aim of this research study is to determine if suppressing the immune system using a     combination of high dose chemotherapy, antibodies, and radiation followed by stem cell     transplant will abolish the 'bad' immune system and let the patient's body establish a new     immune system that does not attack the blood vessels.   "
42585|NCT02728258|"     This phase II trial studies how well copanlisib works in treating patients with endometrial     cancer that has not decreased or disappeared, and the cancer may still be in the body despite     treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
42586|NCT02728245|"     Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs.     upfront surgery to save ovarian reserve in young women with ovarian endometrioma   "
42587|NCT02728232|"     This trial is set to detect the impact of bilateral internal iliac artery ligation on the     amount of intra-operative blood loss during the hysterectomy procedure done for the     management of abnormally invasive placenta   "
42588|NCT02728219|"     The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma     with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP     conversion.   "
42589|NCT02728206|"     This study will evaluate the antiviral efficacy, safety, and tolerability of     sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus     (HCV)-infected adults who are undergoing liver transplantation.   "
42590|NCT02728193|"     The aim of our study was to elucidate the difference in the rates of complication,     hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and     overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for     minimally invasive treatment of very early stage HCC.   "
42591|NCT02728180|"     The main purpose of this trial is to determine whether Xingnaojing, intravenously     administered within 24 hours of symptom onset, improves the 3-month outcome in participants     with acute ischemic stroke.   "
42592|NCT02728167|"     The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR)     results in reduced blood loss compared to standard liver resection in patients with LM.This     is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II     study.   "
42593|NCT02728154|"     Gut microbiota play an important role in normal cardiovascular function and pathophysiology     of cardiovascular diseases. Patients with heart failure (HF) have substantial hemodynamic     changes which lead to intestinal hypoperfusion and congestion and eventually change gut     morphology, permeability, function and composition of gut microbiota and cause translocation     of microbial and endotoxins into the blood stream. Additionally, metabolites derived from gut     microbiota modulate the pathophysiology of HF. Patients with HF have intestinal overgrowth of     pathogenic bacteria and increased gut permeability. Accumulating evidence demonstrates that     antibiotic treatment benefits patients with acute coronary syndromes and reduces the     incidence of ischemic cardiovascular events. Taking the strong association of gut microbiota     with HF into account, it is reasonable to speculate that gut microbiota could contribute to     the progression of pre-HF with preserved ejection fraction (pre-HFpEF) to HF with preserved     ejection fraction (HFpEF). Pre-HFpEF remains poorly understood, yet has high prevalence and a     significantly high risk for death in comparison to patient without pre-HFpEF. We hypothesize     that altered gut microbiota is involved in the initiation and establishment of HF and     pre-HFpEF.   "
42594|NCT02728141|"     Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain     threshold. The opioid system is involved in sucrose's ability to reduce pain and distress     during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and     sucrose analgesia. In order to compare response to pain and sucrose during heel stick in     neonates with and without iron deficiency, healthy full-term Chinese infants were randomized     to receive sucrose or water by syringe beforehand, in conjunction with heel stick for     metabolic screening.   "
42595|NCT02728128|"     The purpose of this study is to identify if circulating platelet cyclic adenosine     monophosphate (cAMP) levels can be used as a biomarker of milrinone efficacy in children     following cardiac surgery or undergoing heart transplant.   "
42596|NCT02728115|"     Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a first-in-human, dose     escalation study in which participants with Huntington's Disease will receive 3 intravenous     injections and will be followed for 5 years to evaluate safety and preliminary evidence of     effectiveness.   "
42599|NCT02728076|"     This study examines the feasibility to deliver accelerated partial breast irradiaiton (APBI)     before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller     volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D     (three dimensional) conformal external beam irradiation. 3D-conformal external beam     irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is     used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks     after completion of the APBI, the cancer will be surgically removed.   "
42600|NCT02728063|"     The main objective of the study is to evaluate the effect on intestinal permeability of a     supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from     irritable bowel syndrome (IBS) with diarrhea predominance.      Secondary objectives of the study are to evaluate the effects of supplementation with     Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea     predominance on intestinal permeability, inflammation of the digestive tract, symptoms and     comfort.      Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel     Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and     non-inclusion listed below.   "
42601|NCT02728050|"     This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte     colony-stimulating factor [G-CSF]), cladribine, cytarabine, and mitoxantrone hydrochloride,     when given together with sorafenib tosylate and to see how well they work in treating     patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome     (likely to be more aggressive). Drugs used in chemotherapy, such as filgrastim, cladribine,     cytarabine, and mitoxantrone hydrochloride work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Sorafenib tosylate may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Giving filgrastim, cladribine, cytarabine, and     mitoxantrone hydrochloride together with sorafenib tosylate may kill more cancer cells.   "
42602|NCT02728037|"     This study will be a randomized, controlled, double-blinded, single-centre superiority trial     with two parallel groups. The primary outcome will be average myofascial pelvic pain in the     two weeks following final injection treatment as assessed using the visual analogue scale.     Randomization will be performed as block randomization with a 1:1 allocation ratio,     stratified based on opioid use at the time of study enrollment. In total, 60 participants     will be recruited and randomized, with 30 being assigned to each treatment arm. The study     will be restricted such that half of the participants enrolled will be current concomitant     opioid users (for any reason) and half will have not used opioid drugs within the 3 months     preceding enrollment in the study.      A third non-randomized arm of 30 participants who are on the waiting list for the chronic     pain clinic will be enrolled and compared to the two randomized arms. Among this patient     population and in the setting of the Chronic Pain Clinic it was determined that it would not     be acceptable to randomize participants to a no-treatment control group. As such, an active     treatment is being used as comparator in the randomized trial. In order to assess     participants in the absence of treatment this third non-randomized arm will serve as a     no-treatment control group.      Eligibility criteria for this third arm is the same as the main study, with the exception of     stratification and restriction by opioid use status. Participation in this third arm will not     exclude a participant from randomization into one of the two main arms of the study.     Therefore, across the three arms, up to 90 patients will be enrolled in this study.   "
42603|NCT02728024|"     The study is undertaken at three German neurosurgical centers (Ulm, Mainz, Stuttgart) between     March 2014 and March 2015. Inclusion criteria were age ≥ 18 and ≤ 80, diagnosis of glioma     WHO° II-IV, absence of aphasia impairing communication or consent. In an outpatient setting     all eligible patients with gliomas were screened for distress (Distress Thermometer (DT)) and     their need for psychosocial support (Supportive Care Needs Survey-SF34-G (SCNS)).     Simultaneously their HRQoL was assessed (EORTC QLQ-C30+BN-20 Vers. 3).      Patients at different disease stages were asked to fill out the questionnaires. At two study     centers patients were asked to complete the questionnaires prior to their appointment with     personal instructions in randomly selected cases. At the third study center, they completed     the questionnaires after their outpatient appointment with personal aid and instructions. At     the time of investigation, patients were at different stages of treatment (chemotherapy,     radiation, re-chemotherapy, re-radiation, none, etc.).   "
42604|NCT02728011|"     The purpose of this study was to examine the feasibility and efficacy of computerized     cognitive exercises from Scientific Brain Training (SBT), compared to the computer game     Tetris as an active placebo, in a pilot study of adolescents with     Attention-deficit/hyperactivity disorder (ADHD).   "
42605|NCT02727998|"     The purpose of this study is to combine a single infusion of Ketamine with 7-days of trauma     focus psychotherapy to relieve post traumatic stress disorder (PTSD) symptoms more     effectively. This treatment has the potential to produce a significant therapeutic effect     that otherwise would take months to occur.   "
42606|NCT02727985|"     The primary purpose of this study is to compare opioid use post-spinal cord stimulation     implant at 1, 3, 6, 9 and 12 month intervals in patients who were provided with a weaning     schedule by the Neuromodulation team (experimental group) versus those who wean on their own     or with their family doctor (control group; standard care) to determine if one strategy is     superior to the other.      The secondary objectives will be to further characterize change in opioid use as it relates     to pain scores, quality of life and disability from baseline to follow-up assessments. The     investigators will examine changes in opioid-related adverse events and medication costs to     help understand the impact of opioid weaning on the patient and the system. The investigators     will also compare worker's compensation patients with non-worker compensation patients to see     if they follow the same result pattern.   "
42607|NCT02727972|"     This research study is designed to look at the involvement of the glutamate system in     depression. Each subject will undergo a screening appointment to determine study eligibility.     Thereafter, the study will take 2 or 3 visits depending on schedule availability and will     consist of one MRI scan, and PET scan. Subjects will also participate in cognitive testing.     Depending on camera time, staff availability and subject schedule, total study participation     may last 1-2 months.   "
42703|NCT02726711|"     The purpose of this study is to learn more about the regulation of the veins of the abdomen     by the autonomic (involuntary) nervous system, and how this may affect high blood pressure.     Normally, the autonomic nervous system controls how much blood flows in the veins. In people     with high blood pressure, however, the autonomic nervous system is changed. This change may     affect the way blood flows in the veins of the abdomen which may play a role in their high     blood pressure. About 32 participants will be screened for the study. The investigators     estimate 16 will be eligible to participate in all of the study days.   "
42608|NCT02727959|"     The IBSEN III study will investigate the incidence of inflammatory bowel disease in South     Eastern Norway and describe the clinical course of the disease. The investigators will map     newly diagnosed and treatment naive IBD patients at various levels (epidemiological,     clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and     microbial) as a basis to improve targeted and individualized treatment and care. The     investigators will include incident IBD patients at all local- and university hospitals in     the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The     investigators will use standardized and validated registration methods allowing comparability     with previous national and international IBD cohorts, link data to national health registries     and collect blood, feces and biopsies for bio banking.   "
42609|NCT02727946|"     Early intervention and resuscitation based upon a lot of clinical, laboratory findings make a     big difference regarding outcome in poly trauma patients, the study uses the dynamic lactate     change and the difference between arterial and venous CO2, oxygen tension or content as     indicators for tissue perfusion.   "
42610|NCT02727933|"     The primary objective of this study is to describe the safety of the combination of Daklinza     (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C     (CHC) genotype 1b patients in real-life conditions when used according to its registered     indications.   "
42611|NCT02727920|"     This study is designed to test the efficacy of energy drinks. This is a double-blinded,     crossover, randomized clinical trial, measuring the effect of the test drinks compared with     placebo drink in 200 participants aged 18-70 years.   "
42612|NCT02727907|"     Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with     the use of active comparator and placebo. Total duration of therapy of about 2 years. Study     hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original     drug Rebif®.   "
42613|NCT02727894|"     The purpose of this study is to determine whether colorectal cancer diagnosed by screening     (primary screening colonoscopy, colonoscopy after FOBT) has a better pTNM classification than     colorectal cancer diagnosed byl other diagnostics (diagnostic colonocopy, CT, MR etc.).   "
42614|NCT02727881|"     A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2%     Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will     receive injections of ranibizumab. In addition, patients will receive either Squalamine     lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to     primary endpoint   "
42615|NCT02727868|"     The evaluation of the impact of environment on the incidence of cancer is a major public     health issue. Increased knowledge in this area is necessary for the implementation of primary     prevention means with appropriate preventive measures but also to the implementation of     secondary prevention measures with targeted screening actions.      Among the environmental exposures that may lead to cancer, mutagenic environments are of     major importance, and the causal link between environmental genotoxicity and cancer has been     established for a long time. It is also well established that susceptibility to mutation is     highly variable among individuals. This is explained by genetic polymorphisms of genes     involved in metabolism and in genome stability.      The identification of biomarkers of exposure to mutagenic environments is necessary for     assessing the impact of an environment in humans. Some studies in animals have shown that the     PIG-A gene may be a biomarker of exposure to a mutagenic environment. In particular, a     significant increase in erythrocyte PIG-A mutants has been demonstrated in rats after a     genotoxic exposure to cisplatin, but it has so far not been evaluated in humans. One study of     healthy volunteers shows that the frequency of PIG-A mutated cells in humans can be estimated     efficiently and reliably.      The PIG-A gene meets all the necessary criteria for a sentinel gene for tracking of     spontaneous somatic mutation frequency or induced a mutagenic environment: ubiquitous     expression, phenotypic change linked to a mono-allelic mutation viability of mutated cells ,     spectrum off inactivating mutations (deletions, substitutions, chromosomal rearrangements).     Finally, the detection of the disappearance of glycosylphosphatidylinositol on the plasma     membrane is easily achievable by flow cytometry.   "
42616|NCT02727855|"     To evaluate the preventive impact, demand, acceptability, uptake, feasibility, and     cost-effectiveness of a two-dose regimen of the OCV Shanchol in children living in urban     slums in Bangladesh, Investigators will conduct a targeted mass immunization programme, using     an innovative approach successfully deployed by the Bangladesh government in its recent     countrywide campaign of MR vaccination of 52 million children aged 9 months to 14 years (<15     years). Investigators will undertake a census of a geographic population of approximately     300,000 persons, with GIS locations of each household. This census will be updated every 6     months during the follow-up period to permit tracking of births, deaths, and migrations,     including changes in location of each individual's residence. Following the initial census,     the OCV will be offered to all non-pregnant individuals aged 1 to 14 years. Operational     research and economic studies will evaluate the coverage, feasibility, acceptability, demand,     costs and cost-effectiveness of this vaccination programme.   "
42617|NCT02727829|"     The aim of the present study is to assess the effects of brachial plexus block on     microcirculation using pefusion index and capillary filling time.   "
42618|NCT02727816|"     The aim of this non-dispensing study is to evaluate the clinical performance of different     hydrogel contact lens designs.   "
42642|NCT02727504|"     Investigators sought to demonstrate that the increase in the stroke volume during a     dobutamine stress echocardiography might impact the prognosis of a patient addressed for a     low flow low gradient suspected severe aortic valve stenosis.   "
42758|NCT02725983|"     Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal     therapy (SPT), on the psychological, behavioral and clinical parameters of patients with     gingivitis, outlined by evidence and a theory-based framework.   "
42704|NCT02726698|"     The purpose of this study is to study clinical factors and (blood) biomarkers related to     progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with     special reference to hypercoagulability. All patients will be continuously monitored for     their atrial rhythm to assess AF progression, either through an implantable loop recorder     (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both     in combination with the CareLink home monitoring system. Remote monitoring and interrogation     will be installed and used on a daily basis.   "
42619|NCT02727803|"     The goal of this clinical research study is to learn if giving cells called natural killer     (NK) cells after receiving 1 of 3 pre-treatment plans and a UCB transplant can improve     response in patients with MDS, leukemia, lymphoma, or MM. The safety of this treatment and     whether NK cells can lessen the risk of graft versus host disease (GVHD) will also be     studied.      If the disease is CD20 positive, you will also receive rituximab on this study in addition to     what is described above. CD20 is a type of marker for white blood cells. White blood cells     help protect the body from infections.      NK cells may kill cancer cells that remain in your body after your last chemotherapy     treatment. The NK cells will be separated from umbilical cord blood. The device used in the     laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then     be grown in the lab to increase the number of NK cells that can be given to you by vein.      Based on your genes, your NK cells may not recover as quickly after transplant. Before the     transplant, blood will be collected for genetic testing as part of standard screening tests.     If the genetic test shows that your NK cells will not recover as quickly after transplant,     you will receive the NK cell infusion.   "
42620|NCT02727790|"     The epidemic nature of type 2 diabetes mellitus, along with the downsides of current     treatments, has raised the need for therapeutic alternatives. The aim of this study is to     evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral     electrical stimulation (PES) as an alternative treatment for diabetes.   "
42621|NCT02727777|"     The goal of this clinical research study is to learn if TAK-228 can help to control relapsed     lymphoma. The safety of this drug will also be studied.   "
42622|NCT02727764|"     This study will evaluate the safety and tolerability of a single intra-articular     administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV) type     5 vector in subjects with RA and active arthritis in the joint.   "
42623|NCT02727751|"     This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects     with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III     criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks)     studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total     based on previous protocol and this study.   "
42624|NCT02727738|"     Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the     control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD)     untreated patients.   "
42625|NCT02727725|"     -  The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization          Transfer and Inversion Recovery) sequence provides at least as good visualization and          detection of sub-endocardial scarring, fibrosis, and acute infarction as the current          gold standard Inversion Recovery (IR) Turbo-Flash sequence.        -  The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in          detecting small sub-endocardial scarring than the inversion recovery segmented gradient          echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the          accepted current gold standard for the detection of myocardial viability.   "
42626|NCT02727712|"     This study intends to compare the combination of general anesthesia (GA) and single-shot     bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing     off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA)     perioperative management of patients, committed to reducing patient's physical and     psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to     establish an more effective perioperative management during off-pump coronary artery bypass     surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation     safely.   "
42627|NCT02727699|"     This XanADu Phase II study in mild Alzheimer's Disease (AD) is to assess the safety,     tolerability and efficacy of Xanamem™ in subjects with mild dementia due to Alzheimer's     Disease. Subjects will be randomized to receive either 10mg once daily Xanamem™ or Placebo at     a 1:1 ratio in a double-blinded fashion.   "
42628|NCT02727686|"     Delayed post-operative hyponatremia occurs in 5-20% of patients following pituitary surgery     and typically occurs on post-operative day 5-10.This decline in sodium can occur rapidly and     have serious consequences such as altered mental status, seizures, coma, and even death.     Despite significant research into patient demographics and risk factors, the investigators     have not been able to predict which patients will suffer from delayed post-operative     hyponatremia to date. At the Barrow Neurological Institute, physicians currently utilize an     outpatient screening protocol to monitor patients' sodium levels after surgery, but this has     yet to be effective for reducing readmissions following pituitary surgery. The etiology of     delayed post-operative hyponatremia has been linked to water and sodium dysregulation in the     post-operative period. It has been shown that post-operative day 1-2 sodium levels are     statistically lower in patients who develop delayed hyponatremia, however, the numerical     differences are not large enough to guide clinical management. The investigators propose that     a water load on post-operative day 1 may expose underlying sodium/water dysregulation in the     early post-operative period. This would improve physicians' understanding of the     pathophysiology of post-operative hyponatremia, and it may help to serve as a screening tool     for these patients in the future.   "
42629|NCT02727673|"     The aim of this study is to establish a platform of detecting and sorting circulating tumor     stem cells from peripheral blood in HCC patients; to investigate the relationship between     circulating tumor stem cells and their effects on postoperative recurrence and metastasis, in     order to provide a new therapeutic target for hepatocellular carcinoma treatment.   "
42630|NCT02727660|"     This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD     exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6     μg, all administered BID.   "
42672|NCT02727114|"     To optimize a medical device for intradermal injection, knowledge concerning the thickness of     epidermis and dermis at the proximal forearm is required. Since scientific knowledge is     lacking, the investigators will examine the skin thickness (epidermis and dermis) of children     (aged 8 weeks to 18 years) using imaging technology (High Frequency Ultrasound). The     investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to     a specific combination of parameters age, gender, and BMI.      Based on these results, the investigators can define which needle type and length is needed     to correctly perform injections into the dermal layer   "
42631|NCT02727647|"     Title: Comparison of different prophylaxis regimens for hemophilia A pediatric patients     Principal Investigator: Assistant Professor Darintr Sosothikul, MD Research Question: Does     different factor VIII dosage effect outcome of hemophilia treatment in term of breakthrough     bleeding, number of hospital stay and day-off from school? Type Research: Clinical research      Study design: Single center clinical trials      Concise methodology:        1. Study Population: Children with hemophilia A who received treatment at KCMH from May          2015 to March 2016 will be enrolled in this study. The consent will be obtained before          the study.        2. Observation and measurement:             1. History, interesting clinical data and laboratory data will be recorded in Clinical               record Form (CRF)             2. Measurement:           i. Complete blood count (CBC), Factor VIII level, Factor VIII inhibitor level ii. Number          of breakthrough bleedings, number of hospital stay and day-off from school iii. Joint          score from Hemophilia Joint Health Score 2.1 iv. EQ-5D-5L quality of life assessment          score        3. Data analysis: The p-value of less than 0.05 will be considered statistically          significant. Mann-Whitney test will be used to test correlation of these variables (CBC,          Factor VIII level, Factor VIII inhibitor level, Number of breakthrough bleedings, number          of hospital stay, day-off from school, Hemophilia Joint Health Score 2.1, EQ-5D-5L          quality of life assessment score) Sample size: 16 patients      Potential impacts:      The outcomes of different factor VIII concentrate dose between 15-20 U/kg/dose 2 times/week     and 35-40 U/kg/dose 1 time/week will be revealed. These outcomes include number of     breakthrough bleeding, number of hospital stay, day-off from school, joint health and quality     of life. The result of this study will guide further study on optimal dose and duration of     factor VIII treatment of hemophilia A patients in the future.   "
42632|NCT02727634|"     The heart is essentially a hydraulic pump which ensures adequate delivery of blood through     generating pressure and forward flow of blood. The energy delivered by the heart is     uncommonly measured clinically, and todays gold standard involves placing a plastic catheter     into the lung arteries. The investigators have developed an ultrasound based approach to     calculate this energy without the need for catheters through the heart. This novel approach     is called ultrapower. Ultrapower involves the instantaneous multiplication of the cardiac     output and the arterial blood pressure. The study aims to use the ultrasound based approach     to investigate Cardiac Power in the coronary artery bypass graft population.   "
42633|NCT02727621|"     Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the     depth of sedation and provides analgesia, cardio protection, renal protection, and     neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor     agonist that modulates the release of catecholamines from the central and autonomic nervous     systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are     calm and cooperative (1). No other sedative agent has this feature, and sedated patients     frequently awaken in a confused state. Investigators are conducting this study project to     compare between dexmedetomidine based and propofol based anesthetic techniques with regard to     hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB     for coronary revascularization.   "
42634|NCT02727608|"     This is a dual centre, single arm, exploratory study of the possibility to use eculizumab     (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the     islets in patients with diabetics accepted for islet transplant.   "
42635|NCT02727595|"     The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex     implant, a button and suture type implant device and instruments for the correction of the     first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.   "
42636|NCT02727582|"     Multidrug-resistant (MDR) tuberculosis (TB), defined as simultaneous resistance to isoniazid     and rifampin, has been declared a global emergency. Treatment outcomes are poor, driven by     toxicity and limited efficacy of the 2nd-line anti-TB drugs.      Although there is evidence that both anti-TB activity and most of the toxicity of the key     drugs are related to drug exposure, the pharmacokinetic/pharmacodynamic (PK/PD) relationships     in patients with MDR-TB are poorly characterized. Moreover potential synergy of drug     combinations has not been identified in the context of MDR-TB, dosing has not taken into     account the concentrations needed to suppress resistance, and the role of minimum inhibitory     concentrations (MICs) in dosing is poorly studied.      There are therefore opportunities to optimize drug doses and combinations to improve     efficacy, and reduce toxicity. Based on this observational study of patients on standard     treatment for MDR-TB, our proposal builds on novel methodologies we have developed, largely     for drug sensitive TB:        1. The application of computational analytical techniques to tease out the individual          contributions of anti-TB drugs used in combination        2. The development of a treatment response biomarker model based on time-to-positivity in          liquid culture of serial sputum samples.        3. The in vitro determination of PK targets for anti-TB activity and the suppression of          resistance using the hollow fiber models of Mycobacterium tuberculosis (Mtb) (HFM-TB).      Thus the research will enhance our understanding of current modalities of TB treatment, while     contributing research approaches for future regimen optimization.      This protocol describes the clinical research component (points 1&2).      Aim 1: To characterize the effects of 2nd-line drug exposures on treatment response in MDR-TB     patients. The 2nd-line drugs to be examined are those comprising the standardized regimen     used in South Africa: kanamycin, pyrazinamide, moxifloxacin, ethionamide and terizidone.      Hypothesis: Amongst patients on standard MDR-TB treatment, variation in drug exposure has a     quantifiable impact on the rates at which viable Mtb are cleared from the sputum.      Aim 2: To identify drug exposures associated with the risk of treatment-related toxicities in     patients on a standard 2nd-line regimen for MDR-TB.      Hypothesis: The risks of specific toxicities associated with kanamycin, pyrazinamide,     moxifloxacin, ethionamide and terizidone are linked to drug concentrations.   "
42637|NCT02727569|"     This study aims to compare two types of visual field test; retinal sensitivity values     obtained with the reference standard Swedish Interactive Thresholding Algorithm (SITA) of the     standard visual field test and with a newly developed test algorithm. The new test is a     visual field test presented on a flat-panel monitor and has two modes: differential light     sensitivity (DLS; equivalent to the standard visual field test) and the Moorfields Motion     Displacement Test (MMDT). DLS sensitivity and DLS measurement variability will be determined     and compared between the SITA algorithm of the standard visual field test and the new visual     field test on the flat-panel monitor. The measurement variability of the MMDT will be     quantified.      The long-term goal is to reduce test variability below that observed in SITA by 20%, whilst     producing comparable measurements (contrast threshold values) for comparable test duration.   "
42638|NCT02727556|"     In functional dyspepsia (FD), abnormal cognitive and emotional changes such increased     sensitization, anxiety, and depression scores have been reported in addition to the     peripheral changes in gastrointestinal tract functions. In this study, investigators will     evaluate the activity of autonomic nervous system, emotional response, and visual attention     to food and non-food images in 30 male and female FD patients and 30 age/gender-matched     healthy volunteers. These data will provide a new finding of the influence of impaired     cognitive processing of food on symptom generation in functional gastrointestinal disorder     patients.   "
42639|NCT02727543|"     The purpose of this study is to evaluate the impact of the Medisafe smartphone application on     blood pressure control and self-reported medication adherence for patients with uncontrolled     blood pressure.   "
42640|NCT02727530|"     The main goal of this study is to get to know if applying manual therapy will reduce the     infant colic symptoms for to improve quality of life of babies and parents.   "
42641|NCT02727517|"     This study evaluates the hypothesis that delayed compared to early umbilical cord clamping     will improve neonatal transition in terms of circulation and breathing during resuscitation.   "
42643|NCT02727491|"     With Institutional ethics board and Health Canada approval, pediatric patients (ages 3-12)     undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be     randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and     again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at     the same time points. The primary outcome is an integrated assessment of perioperative pain     scores and opioid use for 24 hours postoperatively. Secondary outcomes include nausea,     vomiting, respiratory depression, and bleeding for 24 hours postoperatively. Our hypothesis     is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The     improved pain control will be apparent through reduced opioid consumption and integrated pain     scores. This will result in a reduced incidence of opioid-related side effects and adverse     events.   "
42644|NCT02727478|"     This effectiveness-implementation study is a part of the larger study BETA-PD (Balance,     Elderly, Training and Activity in Parkinson's Disease), which has the long-term goal to     reduce the risk of falling in people with Parkinson's disease (PD) by improving balance, gait     and physical activity level. The main hypothesis is that highly challenging balance training     will lead to greater gait and balance ability, increased levels of physical activity and an     improved health related quality of life. The main aims of the study are to evaluate the     effectiveness of the HiBalance program in real-life clinical settings, while exploring     facilitators and barriers for program implementation on a wider scale.   "
42645|NCT02727465|"     At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which     can cause meningitis, blood poisoning and other serious illnesses. Most people carry these     bacteria and never become ill, yet a very small proportion go on to develop these illnesses     which can result in life long disabilities or death. The mechanism by which this happens is     poorly understood and has been studied in various ways, usually focussing on the bacteria or     on the individual, but none has given a definitive answer. This study will be the first of     its kind and will assess the interaction between the host and the bacteria at the genetic     level, through genetic mapping, helping us to understand what makes some people susceptible     to this infection.   "
42646|NCT02727452|"     The randomised study analyzes the effects of immediate bonding (skin-to-skin contact) on     different psychobiological and somatic outcomes of mother and child. The investigators     compare 3 bonding conditions. Cortisol and Oxytocin are also measured during the bonding     process.   "
42647|NCT02727439|"     It is well recognized that chronic exercise protects against the development of     cardiovascular diseases. However, the responses of vasculature to acute exercise (AE) are not     well known and not consistent in literature. Acute exertional exercise can induce large,     transient increases in arterial pressure and development of metabolic acidosis which can be     associated with pro-inflammatory response involving oxidant stress and circulating cytokines     known to impair endothelial function.      The aim of this study is to test the impact of a single exposure to exhausting training on     microvascular reactivity in healthy sedentary subjects and athletes.   "
42648|NCT02727426|"     It is well accepted that high-salt (HS) intake is an essential risk factor in development and     progression of hypertension. Results of some recent studies suggest that some of the     deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may     occur in normotensive individuals and are associated with impaired endothelial function.     However, the effects of acute salt loading on endothelial function and vascular reactivity in     young healthy individuals are still scarce and inconsistent.      The purpose of present study is to determine whether one week of HS intake affects     microvascular reactivity in young healthy subjects without changes in BP. In addition, the     investigators sought to evaluate if potential HS diet-induced microvascular dysfunction is     associated with changes in oxidative stress level and/or with modification of immunological     response in young healthy subjects.   "
42649|NCT02727413|"     The study aims at the comparative examination of pre-, intra- and post-operative release     profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery     under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative     valvular heart disease. Specific attention will focus on the distinction between mediator     release associated with infection and that resulting from CPB. Concomitantly identification     and characterization of infectious pathogens in the circulation and in valvular samples will     be carried out, together with the search for resistance-coding transcripts.   "
42650|NCT02727400|"     Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the     synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg     quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo     maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so     that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the     oocyte. The goal of this work is to analyze the mitochondrial function and energy production     in oocyte donors compared with a group of women of advanced maternal age subject to a same     ovarian stimulation Protocol   "
42651|NCT02727387|"     Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy,     radiotherapy and maintenance therapy.   "
42652|NCT02727374|"     Fear to fall has been proven to be a risk factor affecting those geriatric patients who have     previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy     and psychological combined intervention, aimed at reducing the fear to fall in the     aforementioned patients   "
42653|NCT02727361|"     Dystonia is defined as a syndrome of sustained muscle contractions resulting in repetitive     movements and abnormal postures. DYT1 is the most common form of genetic dystonia, but the     link between genomic mutations and phenotypic expression remains largely unknown.     Furthermore, secondary forms of dystonia have highlighted the role of the basal ganglia,     particularly the putamen in the pathophysiology of the disease. Experimental results in a     genetic model of dystonia in rodents suggest that cholinergic inter-neurons (ACh-I) of the     putamen play a critical role in the pathological process of plasticity in the     cortico-striatal synapse. However, these results have not been demonstrated in humans.   "
42759|NCT02725970|"     The Dietary Guidelines for Americans provide recommendations for making better food and     physical activity choices that promote health and help prevent disease. Yet, few Americans     meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight.   "
42654|NCT02727348|"     Background:      Dysautonomia refers to the abnormal function of the autonomic nervous system including     sympathetic and parasympathetic nervous system. Diabetes mellitus causes secondary     dysautonomias (1). The Survey of Autonomic Symptoms (SAS) is a simple and validated tool to     assess the presence and severity of autonomic symptoms (2).      Diabetic patients also suffer from chronic neuropathic pain. After amputation surgeries, up     to 78% of these patients may develop post surgical neuropathic pain (3). The self-report     version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) is     validated as a diagnostic tool to assess patients with neuropathic pain (4). This scale will     be used to assess if there is any changes in the pain experienced after diabetic foot     surgery.      Currently, both spinal anaesthesia (SAB) and ultrasound guided femoral and sciatic peripheral     nerve blocks (FSNB) are acceptable anaesthesia for dysautonomic diabetic patients with     diabetic foot ulcer going for wound debridement, Ray's amputation and below knee amputation     (5)      Many studies have compared multiple perioperative parameters of patients undergoing lower     limb surgery under peripheral nerve blocks versus spinal anaesthesia. These parameters     include preparation time, anaesthetic complications (e.g. hypotension, nausea and vomiting,     post-dural puncture headache, urinary retention), patient satisfaction and postoperative pain     control (6,7,8).      The investigators want to study if patients with dysautonomia have a different haemodynamic     response to spinal anaesthesia or peripheral nerve blockade changes compared to patients with     normal autonomic function.      Secondarily, the investigators would also study if there is a difference in post operative     pain control as well as incidence in chronic pain in patients who receive spinal anaesthesia     versus peripheral nerve blockade.   "
42655|NCT02727335|"     Description of clinical and anatomical features and long-term follow-up for patients with ALK     rearrangement and treated by crizotinib   "
42656|NCT02727322|"     The specific aim of this randomized double-blind placebo-controlled trial is to determine if     extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic     urinary tract infection (UTI) compared with placebo for patients undergoing short term     indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary     retention following pelvic organ prolapse and/or urinary incontinence surgery.      Consented patients who undergo urogenital surgery and fail their post-operative voiding trial     will be randomized to either extended release nitrofurantoin 100mg or an identical appearing     placebo capsule to be taken daily while performing CISC or while indwelling catheter is in     place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of     surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and     incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women.      Primary and secondary outcomes will be evaluated with Student t test and chi squared or     Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to     nitrofurantoin prophylaxis from 33% to 13%, with 80% power, and a two-sided alpha of 0.05,     and a 10% dropout rate, we should recruit a total of 154 patients.   "
42657|NCT02727309|"     This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in     treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival     (PFS), 3-month PFS, 6-month PFS and 1-year PFS.   "
42658|NCT02727296|"     To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on     the incidence of acute rejection in recipients of living, donation after circulatory death     (DCD) and donation after brain death (DBD) donor kidneys.   "
42659|NCT02727283|"     GSK3179106 is a potent and relatively selective inhibitor of RET kinase which has been     designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients .      This is a randomized, double-blind (sponsor unblind), placebo-controlled, dose escalating,     four period, single-dose crossover, first time in human study to assess the safety,     tolerability and pharmacokinetics of GSK3179106 in normal healthy subjects.      The study will be composed of 2 cohorts, each having screening (21 days prior to first dose     of study drug), Treatment, and follow-up periods (7-10 days after their last dose [Day 1 of     dosing period 4]). The Treatment period will include 4 dosing periods. Subjects will     participate in either Cohort 1 or Cohort 2. The total duration of the study for each subject     will be approximately 10 weeks. A sufficient number of healthy subjects will be screened to     enrol 16 subjects who complete the planned study procedures. Each dosing period will be     staggered so that only 2 of the 8 subjects will be administered study drug initially. Once 24     hours (h) have elapsed, and provided there are no safety concerns, the remainder of subjects     scheduled for that dosing period may be dosed. A review of safety and tolerability will occur     prior to administration of the next dose level. This same procedure will be followed for each     escalating dosing period. Subjects assigned to Cohort 1 will participate in 1 placebo and 3     dose escalating periods. Subjects assigned to Cohort 2 will participate in up to 4 dosing     periods which include up to 2 escalating doses and placebo in Periods 1 and 2, and a pilot     food effect in Periods 3 and 4. Within each cohort, subjects will return for their next     scheduled dosing period approximately 14 days after administration of the study drug during     the prior dosing period. Cohort 2 will proceed after completion of the treatment periods in     Cohort 1. Each subject will be enrolled in only one cohort. The planned dose range is 10     milligram (mg) to 200 mg in Cohort 1. The actual doses to be administered may be adjusted     based on safety, tolerability, and pharmacokinetic data at previous dose levels; these dose     adjustments may involve either an increase or a decrease in the planned dose for both Cohorts     1 and 2. There are no formal hypotheses being tested in this study.   "
42660|NCT02727270|"     The objective of this study is to evaluate the cortisol awakening response with persons with     PD and moderate levels of stress as compared to controls and persons with PD and low levels     of stress. These data are desired so experience can be gained with measuring stress levels     subjectively and objectively in persons with PD.   "
42661|NCT02727257|"     In this study the Investigators explore two questions: if the attentive reaction times     differs in parkinsonian patients from health controls and if an intensive, focused and     aerobic rehabilitation program (Multidisciplinary Intensive Rehabilitation Treatment - MIRT)     tailored mainly for motor problems, could have a specific positive effect on multiple choices     Reaction Times (RTs) as an indirect marker for an effect on attentional-executive frontal     circuits. The hypothesis is that the MIRT could have a positive effect on the top-down     control mechanisms, since the continuous feedback given by physiotherapist during exercises     and the use of cues and devices (such as treadmill plus and stabilometric platform),     stimulate the selective attention processes that enable goal-directed, internally-driven     decision, helping the patients to overcome externally-driven decision based on stimulus     salience and novelty   "
42662|NCT02727244|"     This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and     Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.   "
42673|NCT02727101|"     The goal of the present study is to evaluate (screen) a large number (12) of different dual     therapies of perampanel + another AED (PMP+) for a large, 75-100% seizure frequency     reduction. The design of the study will differ from usual AED studies. The study will be (i)     open label, with (ii) a small n per group, n=6, with (iii) outcome measures a 'blockbuster     effect': (a) ≥75 seizure frequency reduction; and (b) seizure freedom.   "
42674|NCT02727088|"     Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50%     worldwide, probably directly related to the difficulty of the procedure. A successful     pulpotomy allows the preservation of a vital radicular pulp into the root canal. The presence     of a biological tissue into the root canal is definitely more efficient than a complete     filling with an inert material. It has been shown on animal and human studies that this pulp     stump in contact with the biomaterial is able to regenerate a dentinal plug, with the same     architecture as physiologic dentin.      Primary objective : To compare the success rates of root canal treatment (reference) and     conservative treatment (pulpotomy) for treating inflamed dental pulp on permanent mature     teeth.      Secondary objectives : (1) To describe the clinical and biological prognostic factors of     these two treatments; (2) to assess the additional value of biomarkers expression levels as a     prognostic tool for clinical decision making (radical vs. conservative treatment); (3) to     assess the impact of treatment on post-procedural pain.      This trial aims to demonstrate the non-inferiority of conservative pulpal treatment over     endodontic treatment.      Patients consulting in one of the seven study centers, presenting one of the indications     retained for the trial and giving written informed consent will receive the treatment     (endodontic treatment or conservative treatment) allocated by randomization (stratified over     the clinical diagnosis of the pulp status).      The follow up of patients include, a phone call at D15, and visit at 1, 6, 12 and 14 post     operative months. Clinical examination and Xrays at 6, 12 and 24 months) will be used to     evaluate the success or failure of the treatment.      During the treatment, a sample of pulp tissue will be withdrawn and transferred to a     molecular biology laboratory for analysis of inflammation biomarkers. The aim of this part of     the sudy is to assess a putative relationship (1) of regulation of biomarkers expression and     clinical diagnosis, and (2) of regulation of these biomarkers and success rate of pulpotomy.      Success/failure evaluation:      The primary endpoint is the time to necessity of endodontic reintervention (analysed as a     time to failure). This study will use an Intention To Treat analysis as its main assessment ;     a secondary assessment accounting for peroperative conversions will assess the practical     impact of these conversions. We will distinguish        -  Direct failure (means that the failure is directly correlated to the treatment) : the          reintervention need is due to the evolution of the treated tooth. This includes delayed          onset of desmodontitis, periodontal space enlargement and/or periapical/periradicular          radiolucency (PAI>2) demonstrating an infection of the root canal system (filled by          either pulpal stump or filling material).        -  Indirect failure (means that the cause of the failure is not directly related to the          endodontic treatment choice) : any event leading to endodontic reintervention indication          NOT caused by radicular infection or restoration failure attributable to inadequate          restoration. For example : new need of post-placement for treatment of loss of another          tooth, unexpected progression of periodontal disease.      Both these failure modes are of interest for analysis : the direct failure time is an     indication if the intrinsic value of a therapy, whereas the gross (direct+indirect) failure     time is an indication of its clinical relevance (a good therapy applicable in rare cases may     be less interesting than a mediocre but widely applicable one).      Statistical analysis:      The classical methods of descriptive analysis will be used to describe the raw results.      In order to make inferences directly on possible clinical results, this study will be     analyzed in a Bayesian framework.      This study has been designed in reference with a frequentist demonstration of     non-inferiority.      A non-inferiority trial with first and second species error rates α and β has the same     operational characteristics as a superiority (unilateral trial) of error rates alpha and     beta, which in turn needs the same study size as a comparison (=bilateral) trial with error     rates α and 2β.      The final planned size of the trial is established as follows :        -  Ideal plan : a nonparametric comparison (logrank test) fulfilling these goals according          to this plan needs 158 patients overall under perfect information assumptions (no loss          to follow-up, single analysis)        -  Loss to follow-up : the expected loss to follow-up will cause about 22% of included          patients to drop out of the study before final analysis this leads to include 194          patients overall.      Sequential analysis : since we wish to be able to follow the progress of the study, and to     interrupt it if the main goal is reached, we choose to use a sequential analysis. A Pocock     scheme needs to increase the sample size by 16% , leading to plan to recruit 226 patients     overall.   "
42675|NCT02727075|"     This study aims to characterize the diagnostic performance of immunological testing of occult     gastrointestinal bleeding in stool in the population aged over 75 years with iron deficiency     anemia.      As secondary objectives, the study aims to:        -  determine a threshold of positivity optimizing the immunoassay performance for the study          population, in accordance with the probabilities of error (false positives, false          negatives) and weights (defined by expert consensus) allocated to these errors.        -  Assess the benefit of a double measure of bleeding (two stools) by immunoassay compared          to a single measure.   "
42663|NCT02727231|"     The main objective of this study is to determine whether day and night closed-loop insulin     delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy     in adults with type 1 diabetes and HbA1C<7.5%.      This is an open-label, multi center, randomized, crossover design study, involving a 2-4 week     run-in period, followed by two 4 weeks study periods during which glucose levels will be     controlled either by an automated day- and night closed-loop system or by subjects usual     insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed     subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C<7.5% will be     recruited through diabetes clinics and other established methods in participating centers.      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery     system. Subjects will have regular contact with the study team during the home study phase     including 24/7 telephone support.      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by     CGM during home stay. Secondary outcomes are time spent with glucose levels above and below     target, as recorded by CGM, and other CGM-based metrics.   "
42664|NCT02727218|"     prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will be     divided into two groups, the first group will undergo early chest tube removal - after three     hours, the second group will have late chest tube removal according to the department's     protocol.      the study aims to prove the possibility and non inferiority for early chest tube removal for     thoracoscopic surgeries with non complicated surgical course.   "
42665|NCT02727205|"     STUDY TITLE:      A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat     Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine     Transdermal System), 1 mg/24 hr in Healthy Volunteers      TEST DRUG / INVESTIGATIONAL PRODUCT:      Rotigotine Transdermal System, 1 mg/24 hr      INDICATION STUDIED:      Bioequivalence - Irritation and Sensitization      STUDY DESIGN:        -  Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study        -  One-half (½) of the test patch and one-half (½) of the reference patch was applied daily          to the same site for each product over a 21 day period followed by a rest phase and a          challenge phase   "
42666|NCT02727192|"     Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with     prevalence expected to rise significantly the coming decades. The occurrence of AF is     associated with significantly increased mortality as well as morbidity of which     cerebrovascular accidents is the most important. Unfortunately treatment options remain     limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential     for toxicity and adverse events are recognized. Recent year's catheter ablation of AF     continues to gain acceptance for symptomatic treatment, but recurrence rate are high with     need for continuous medication. Thus there is a need to better understand what causes     development and triggers episodes of AF as well to introduce new treatment options.     Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore     gained interest. Many patients with AF have chronic sleep apnea, and in the present study we     want to explore the interaction between SA and AF. The hypothesis of the present study is     that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well     as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis we will     implant a Reveal device that continuously records the hearts rhythm of 100 patients with     paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be     examined, and the patients will then be randomized to treatment of SA or not and the     influence on total AF burden recorded both before and after ablation.   "
42667|NCT02727179|"     This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with     colorectal liver metastases. Half of participants will be operated on by laparoscopic     approach and the results obtained will be compared with the results from the other half of     patients operated on by open approach.   "
42668|NCT02727166|"     Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we     hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a     prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods.     Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with     abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will     receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A     gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms     and gas retention for 3 h) will be performed before and at the end of the intervention phase.     Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal     bifidobacteria counts will be measured before and at the end of the intervention.   "
42669|NCT02727153|"     Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in     colonic laparoscopic resections because of faster recovery and less perioperative     complications.      Objective. Aim of this study is to assess safety and feasibility of discharging patients     operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first     flatus has passed and in the absence of complication-related symptoms.      Design & Settings. Non-inferiority, open-label, single center, prospective, randomized study     comparing Ultra to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.      Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384     patients were assigned to Ultra E.R.A.S. and 381 to Classic E.R.A.S.      Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality,     along with surgical complications, re-operation and readmission rate were recorded and     compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission     and re-operation rate.      Limitations. It is a single center experience; it is not double-blind, with the intrinsic     risk of intentional or unconscious bias; exclusion criteria because of non compliance may     be considered arbitrary.   "
42670|NCT02727140|"     The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit     of a supportive hatha yoga intervention for patients with hypertension using antihypertensive     drugs. Patients will be randomized into 3 groups comparing hatha yoga with yoga postures,     breathing and relaxation techniques to a hatha yoga intervention without yoga postures (only     breathing and relaxation techniques) as well as to a wait list control group.   "
42671|NCT02727127|"     In this project, investigators intend to carry out the first simultaneous, in vivo, imaging     study of lithium content and sodium ion homeostasis in the brain of Bipolar Disorder (BPD)     patients under Lithium therapy.   "
42677|NCT02727049|"     The purpose of this research is to:        1. determine the normal or existing dynamic biomechanics of college athletes and        2. test the effectiveness of osteopathic manipulative medicine in the treatment of athletic          injuries.      Motion capture using Vicon systems allows researchers to quantify characteristics of a body     such as the range of motion of the hip or shoulder during an athletic technique such as     kicking or shooting a basketball into the basket. The quantified information has been used     before to better understand human mobility and performance. Osteopathic manipulative medicine     (OMM) is manual medicine applied to joints, muscles, and connective tissue with a goal of     improved body functions. Research demonstrating effectiveness of OMM on the musculoskeletal     and associated connective tissue systems health includes, among others, prospective clinical     trials of OMM for treatment of neck pain, low back pain, and acute first- and second-degree     ankle sprains.   "
42678|NCT02727036|"     The purpose of this randomized control trial is to compare the effect of pumpkin seed oil     2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of     lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function,     serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in     postmenopausal women.   "
42679|NCT02727023|"     The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump     Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure     the canabinomimetic effects of osteopathic treatment.   "
42680|NCT02727010|"     Background Women with rare diseases resulting in motor disabilities wishing to become mother     face a major challenge. The investigators hypothesize that provided with adequate support,     they are able to achieve a successful pregnancy and to offer their child a safe family     environment.      Methods To test this hypothesis, the investigators shall conduct a prospective observational     prospective survey of a consecutive series of volunteer pregnant women or mothers of children     less than 14 months, with motor impairment, participating in a program of parenting support     developed in our institution.      Primary outcome: social environment, child development, mother-infant attachment, mother-     infant interactions Secondary outcome: social and demographic characteristics, severity of     motor impairment, associated impairment, perinatal morbidity for the mother and the infant     (composite indicator), emotional status, and the needs expressed by women regarding the level     of medical or social care.      Analysis The investigators shall describe the distribution of the primary outcome     measurements in the subgroup of women with motor impairment related to a rare disease. The     investigators shall compare this distribution to the expected distribution in the general     population, and to that observed in women with motor impairment unrelated to a rare disease.     The investigators shall also study primary outcome measurements as a function of the severity     of maternal disability, of the mother's social characteristics and emotional status.      The investigators shall also describe the distribution the distribution of perinatal     morbidity globally, and as a function of the potential explanatory variables mentioned above.      The investigators shall also report on the opinion of women regarding the support they were     offered so far, and the support they declare they should benefit from.   "
42681|NCT02726997|"     The goal of this clinical research study is to learn about the safety of giving the     combination of MEDI4736 (durvalumab), carboplatin, and paclitaxel to patients with high-grade     epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer. Researchers     also want to learn how the study drug combination may affect DNA and RNA (the genetic     material in cells) and proteins.   "
42682|NCT02726984|"     Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based     on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition of     the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke.     Identification of new predictive factor of ipsilateral ischemic stroke in patients with     carotid plaque could help to screen high risk patients and to guide the treatment. The aim of     the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently     symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study.     Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50%     NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and     tissue-to-background ratio (TBR) will be measured among carotid plaques.   "
42683|NCT02726971|"     This single-center,prospective,randomized,controlled trial is conducted to evaluate the     efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic     adhesiolysis in patients with moderate-severe adhesion.   "
42685|NCT02726945|"     This is a pivotal study. The study will examine the safety and efficacy of autologous     adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for     pain, function and stiffness in the knees of osteoarthritic subjects.   "
42686|NCT02726932|"     The purpose of this study is to analyze the correlation between intra-abdominal view and     patient recovery in secondary peritonitis, and to create a new classification based on these     results. Additionally, a variety of inflammatory markers from blood samples will be collected     in order to analyze their correlation with patient outcomes.   "
42687|NCT02726919|"     The goal of the present study is to obtain pilot data on efficacy and safety of clobazam     add-on treatment on adults with drug-resistant focal epilepsy.      This will be an open label study comparing seizure frequency during 12 weeks of baseline     observation period with seizure frequency during 16 weeks of clobazam adjunctive treatment.     10 adults aged 18-65 with focal seizures that have failed to respond to ≥ 4 antiepileptic     drugs (AEDs) +/- respective surgery will be enrolled. Following a baseline of 12 weeks     patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in     whom seizure diaries have been kept prospectively prior to study screening visit,     retrospective baseline will be accepted. Patients will be titrated up to either seizure     freedom, to side effects or to 40 mg/day, whichever comes first. Titration rate will be not     be forced. It is anticipated that the majority of subjects will have a 4 week-long titration     period. After maximum dose is achieved, maintenance treatment will last for 12 weeks.   "
42688|NCT02726906|"     The purpose of this study is to examine the effects of modifiable lifestyle factors including     exercise and healthy living on brain health. The investigators will compare 2 types of     interventions, moderate aerobic walking vs. healthy living education, over 6 months to     evaluate changes in brain health, cognition, and physical function in older adults with     cognitive concerns.   "
42689|NCT02726893|"     About 30% of patients were reported to suffer inadequate bowel preparation.   "
42705|NCT02726685|"     The purpose of the research is to investigate the effects of respiratory training on     respiratory and functional performance in patients with stroke.   "
42706|NCT02726672|"     The purpose of this study is to assess the effect of a training of the inspiratory muscles     against resistance at home during 10 weeks in multiple sclerosis patients with a severe     disability.   "
42690|NCT02726880|"     The fifth revision of the Diagnostic and Statistical Manual for Mental Disorders includes in     its research appendix a potential new diagnosis—Internet gaming disorder. This condition     primarily affects adolescent boys and young adult men, who rarely seek treatment on their     own. More often, parents express concerns about their child's game playing behaviors. This     psychotherapy development study will evaluate feasibility and effect sizes of an intervention     designed to help parents reduce their child's gaming problems; the intervention allows for     child participation, but it is geared toward parents, regardless of whether or not their     child is willing to participate. A total of 40 parents concerned about their child's gaming     behaviors will complete self and parental report inventories and structured diagnostic     interviews regarding gaming, substance use and psychosocial functioning. Children who elect     to participate will complete parallel versions of the instruments. Participants will be     randomized to a control condition consisting of referral for mental health issues and family     support services or to a 6-week behavioral intervention designed to assist with better     monitoring and regulating the child's game playing behaviors. Gaming and other problems will     be assessed pre-treatment, at the end of treatment and at a 4-month follow-up. This study     will be the first to evaluate the reliability and validity of a parental version of the fifth     revision of the Diagnostic and Statistical Manual for Mental Disorders criteria for internet     gaming disorder in a clinical sample, and it will assess associations of internet gaming     disorder with substance use, mental health conditions, and family functioning as well. This     study will be the first randomized trial of an intervention designed to assist parents in     reducing their child's gaming problems, and results will help guide future development of     interventions for Internet gaming disorder. To evaluate the feasibility and acceptability of     this intervention, the proportion of parents assigned to the intervention who complete 6     sessions will be examined, as will the proportion of youth who attend the sessions. Parent     and child ratings of satisfaction with the intervention will be assessed. To examine the     effect size of the intervention on reducing gaming, parental reports of proportion of days on     which their child played games and durations of game playing will be compared between     conditions, controlling for baseline indices.   "
42691|NCT02726867|"     The purpose of the study is to evaluate the efficacy and safety of levetiracetam , lacosamide     and ketamine treatment of refractory status epilepticus. This will be a randomized,     open-label, four-arm pilot study comparing time to cessation of refractory status     epilepticus, determined by continuous EEG monitoring, in patients with refractory status     epilepticus. Patients with status epilepticus who have been treated with standard dose     lorazepam (or midazolam) and ≥ 1000 mg phenytoin with documented levels of ≥20 mg/ml and     continue to have clinical status epilepticus for ≥1-24 hours after phenytoin loading will     receive intravenously (i.v.) either 4000 mg levetiracetam, 600 mg lacosamide (Group B), 2.5     mg/kg ketamine or phenobarbital 15 mg/kg phenobarbital (Group D)   "
42692|NCT02726854|"     The main research purpose Evaluation of objective response Apatinib second-line treatment of     advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS).      Objective to study the objective and exploratory secondary research To observe the Apatinib     in second line treatment of advanced pancreatic cancer disease control rate (DCR), patients     with overall survival (OS) benefit, treatment effects on quality of life (QOL) score and drug     safety evaluation, To investigate the relationship of apatinib as second-line treatment of     advanced pancreatic cancer and the expression of vascular endothelial growth factor     receptor(VEGFR) in the serum   "
42693|NCT02726841|"     Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent     implantation is superior over standard thoracoabdominal aortic repair.   "
42694|NCT02726828|"     this study investigates the analgesic efficacy and other possible effects of ketamine,     morphine, and both together when administered intrathecally for control of postoperative pain     following lower abdominal cancer surgeries.   "
42695|NCT02726815|"     Primary Objective      The aim of this research study is to develop a comprehensive inventory of symptoms that occur     in children with advanced cancer who are receiving a specialist palliative care service.      Secondary Objectives        -  To assess correlation between parent, child and nurse scores on the Memorial Symptom          Assessment Scale (MSAS).        -  To identify symptom prevalence in children with advanced cancer as identified by the          child/young person (CYP), nurse and parent (to be analysed separately for parent, child          and nurse).        -  To identify whether there are any symptoms missing from the age appropriate MSAS as          identified by the CYP, nurse and parent (to be analysed separately for parent, child and          nurse).        -  To identify whether any items on the age appropriate MSAS are not relevant to the          population being studied (to be analysed separately for parent, child and nurse).        -  To identify which symptoms cause the most distress as identified by the CYP, nurse and          parent (to be analysed separately for parent, child and nurse).        -  To identify degree of severity of each symptom as identified by the CYP, nurse and          parent (to be analysed separately for parent, child and nurse).        -  To identify which symptoms occur most frequently as identified by the CYP, nurse and          parent (to be analysed separately for parent, child and nurse).        -  To assess the trends between phase of illness and symptom profile, severity and          distress.   "
42696|NCT02726802|"     This study aims to compare the self-report functional outcome measures, medical readiness and     healthcare utilization (overall cost of imaging, prescription medications for pain, and     follow-up visits) of soldiers with musculoskeletal injuries first seen by a physical     therapist versus primary care provider.   "
42697|NCT02726789|"     The REP 201 protocol is a small exploratory study assessing the antiviral effects and     tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks)     in treatment naive patients or in patients already receiving entecavir and continuing     entecavir with treatment.   "
42698|NCT02726776|"     Suspension syndrome refers to a potentially life-threatening condition that can occur in     unconscious persons after prolonged suspension in a harness. To date, our understanding of     the pathophysiology and appropriate treatment is based primarily on case reports and expert     opinion. The main pathophysiological hypothesis implicates blood pooling in the lower     extremity and lack of return via muscle pumping. However, a recent French study could not     support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in     the pathophysiology of suspension syndrome. The aim of this study is to better understand the     pathophysiological basis of suspension syndrome and to develop practical recommendations for     prevention and treatment.   "
42699|NCT02726763|"     In this study, the investigators are testing transcranial direct current stimulation (tDCS)     in breast cancer survivors. In this pilot study, the investigators want to learn if it is     feasible to use this device in memory rehabilitation.   "
42700|NCT02726750|"     The goal of this clinical research study is to find markers that might help predict why some     patients with monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple     myeloma (SMM) develop multiple myeloma, while others do not.      Markers that will be studied may include participant's age, level of proteins in blood and     urine, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells,     and bone abnormalities.   "
42707|NCT02726659|"     The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial     of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II     postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar     disorder in the postpartum treatment will receive either a placebo or celecoxib add-on     treatment. Patients will be monitored regularly to assess psychiatric symptoms and side     effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib     in bipolar postpartum depression.   "
42708|NCT02726646|"     Summary The aim of this study is to evaluate through clinical, microbiological and     immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid)     containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this     study, 40 patients will be selected, with an average age between 30 and 59 years old of both     genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba     Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites     with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth.     Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease     carriers or antibiotics used in the 6 months preceding the study. All patients will receive     oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival     sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB +     DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20     patients who will receive the following treatments: periodontal debridement ultrasound for 45     minutes associated with the local administration of 1 mg microspheres containing doxycycline,     or just mechanical debridement, for each selected site. Will be assessed the following     clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP),     Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment     Level (RCAL). The microbiological evaluation will be made by means of polymerase chain     reaction - real time ( real time - PCR) to detect bacteria: Porphyromonas gingivalis,     Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and     Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine     levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α. The analysis     of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and     MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the     initial visit. The results are compared statistically by analysis of variance with repeated     measures with 5% significance level.   "
42709|NCT02726633|"     A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the     diagnosis of lung cancer.   "
42710|NCT02726620|"     The purpose of this study is to determine whether a decision support system can improve the     adherence to thresholds for low blood pressure by anesthesia providers, which in turn     prevents their patients from having organ injury.   "
42711|NCT02726607|"     The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women     before, during and after delivery and evaluate the HITSystem impact on prevention of     mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0     intervention will support a range of PMTCT outcomes including retention in care, ART     adherence, and integration of maternal and pediatric HIV services in low-resource settings.   "
42712|NCT02726594|"     The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and     to measure examination conditions and factors that may affect the image quality and thus the     diagnostic accuracy. For this purpose a total of 1000 participants enrolled in the study,     consisting of healthy volunteers (N = 300) as well as patients (N = 700), that are assigned     to the clinically indicated MRI scan. In this study, individual regions of the body are     studied by MRI (for example, knee, ankle, head or spine). For all participants of the study,     the investigation for each region examined is exactly the same except that a single external     factor is changed or is different. Such variable factors may include: the tube diameter of     the magnet, weight of the coil, which is closely attached to the examined area of the body,     the height adjustment of the table on which the participants lie, the duration of the study     protocol and the generated volume during the investigation. Participants are involuntarily     subjected to the particular MRI scanner and setting by availability of USZ Radiology     disposition. For the evaluation of the data, participants will be matched in terms of the     body regions being examined and based on being part of the patient or subject group. Due to     the fine different experimental conditions, the influence of these factors on study patient     comfort, as wells as the image quality and thus the diagnostic accuracy will investigated. By     this approach, the relevant factors will be examined in isolation. Only by exploring the     patient's perception/comfort during an MRI scan, the patient-orientated design of the study     conditions can be improved and thus the possibilities of modern MRI technology can be fully     utilized in clinical practice.   "
42714|NCT02726568|"     This trail is to designed to assess the efficacy and safety of high dose Iconitib for NSCLC     patients harboring EGFR mutation with brain metastases.   "
42715|NCT02726555|"     Double-dose statin regimen achieves merely 6% of decrease in low-density lipoprotein     cholesterol (LDL-C) levels, whereas the risk of side effects increased largely. The     investigators' previous pilot study (NCT01686451) has suggested that red yeast rice was of     similar lipid-lowering efficacy while was associated with less fatigue than statins. The     purpose of this study is to evaluate the efficacy and safety of combined therapy with red     yeast rice and low-dose atorvastatin in persons with mild atherosclerotic cardiovascular     disease and who qualified for statin therapy according to national guidelines.   "
42716|NCT02726542|"     Fatty liver disease is an increasing problem in overweight and obese young adults. The     purpose of this study is to test the effect of growth hormone on liver fat in obese young     adults ages 18-25y with increased liver fat.   "
42717|NCT02726529|"     The purpose of the research is to find out how well a new nutrition program works for     elementary school students and their families. This program is called Brighter Bites.     Brighter Bites is a school-based program that teaches students and their parents about the     importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy     ways. This project is being carried out at six elementary schools in Houston, Texas. Up to     600 first grade students and their parents/guardians are expected to join this project.   "
42718|NCT02726516|"     Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise     performance, oxidative stress and muscle damage.      The hypothesis is that supplementation with PRJ-205 improve aerobic performance   "
42925|NCT02723799|"     This study aims to:      I. Develop and pilot test the effectiveness of a Hope Promotion Program compared with the     standard treatment protocol, in hope, comfort and quality of life, based on a population of     palliative patients followed at Oncology day care unit.      II. Evaluate perceptions and acceptability of Hope Promotion Program among palliative     patients submitted to the intervention program.   "
42719|NCT02726503|"     The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for     anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of     the study will be 30 months. All patients will start administration of lenvatinib within 1     week of enrollment and receive the study drug 24mg orally once daily at almost the same time.     1 cycle consists of 4 weeks. Treatment term starts on the day 1st of drug administration of     cycle 1 and administration will be continued until patients meet withdrawal criteria. Safety     and efficacy assesment will be conducted on a regular basis during the trial. Tumor     evaluation will be conducted at 4weeks, 8 weeks, 12 weeks, 16 weeks and at every 8 weeks     after the 16th week since initial administration. When study drug administration     terminated,tests of the drug termination will be conducted within 7 days of withdrawal and     final observation will be conducted at 30 days after the last dose. Survival survey will be     conducted at follow-up term. After the termination of the study drug, survival follow up     survey will be conducted every 12 weeks unless patients withdraw enrollment of this study.   "
42720|NCT02726490|"     A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management     of diabetes in pregnancy.   "
42721|NCT02726477|"     The purpose of this study is to assess the efficacy and safety of Wuling San, a traditional     Chinese medicine, in reducing arm volume excess in women with stage I-II breast cancer     related unilateral lymphedema.   "
42722|NCT02726464|"     This is an observational study that evaluates the characteristics of Platelet Rich Plasma     used in the therapy and treatment of musculoskeletal injuries and degenerative joint     diseases.      A sample of the PRP will be tested for platelet and microparticle content using dynamic light     scattering to determine if there is a relationship between the composition and the treatment     outcome.   "
42723|NCT02726451|"     The primary objective of this study is to determine the efficacy of Sensi Peel®, Rejuvenating     Serum, and the C&E Strength Max skin care products in subjects who undergo full facial     rejuvenation, with a botulinum neurotoxin A and/or hyaluronic acid filler, in improving the     appearance of the skin, patient satisfaction with aesthetic appearance, and the projected     first impressions.      The secondary objective of this study is to examine patient satisfaction with the continuous     use of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max products.   "
42724|NCT02726438|"     Debio 1450 is being developed for the treatment of staph (staphylococcal) infections. How     fast and completely an antibiotic penetrates into bone is used to determine how effective it     might be to treat infections related to bones or joints. Since bone has fewer blood vessels     than other tissue (for example lung tissue or the skin), drugs have a harder time getting     into them. It is important to find out how much of the antibiotic can get into the bone to     help patients with bone infections.   "
42725|NCT02726425|"     This study evaluates the comparative effectiveness of a diabetes self management (DSM) group     medical visit in the virtual world (Second life) verses a face-to-face format, aimed to     increase physical activity and improve glucose control among Black/African American and     Hispanic women with uncontrolled diabetes mellitus.   "
42726|NCT02726412|"     This study aims to describe the postoperative functions of patients with ischaemic lower     extremities after undergoing revascularisation surgery . Primary endpoints will focus on     complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to     the general ward. This include Aldrete scores and other complications that can be registrered     descriptively. Furthermore, the study seeks to compare the complications outcomes between     acute and elective revascularisation surgery.   "
42727|NCT02726399|"     The purpose of this study is to compare any good and bad effects of using ramucirumab along     with the usual trastuzumab and chemotherapy to using the usual chemotherapy and trastuzumab     alone.   "
42729|NCT02726373|"     Objective: To compare effects of an intermittent and continuous walking program on walking     endurance and fatigue in people with multiple sclerosis (MS).A randomized crossover     prospective method was used.The intervention consisted of eight 6-minute-long walks (2x/week     for 4 weeks). The continuous condition consisted of 6 continuous minutes of walking. The     intermittent condition consisted of three 2-minute bouts with 2-minute rests. After a 4-week     detraining period, participants performed the second training condition.   "
42731|NCT02726347|"     The study is looking at the pneumonia vaccine and the immune system response to this vaccine.     The information gathered from this study may be important for your doctor to take care of     patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary     Disease (COPD), or elderly patients. It is important that your immune system builds a strong     defense to the vaccine so that you are better able to fight a bacterium that can cause     pneumonia. Some disease prevent the immune system from building a strong defense and these     patients will not benefit from the vaccine.   "
42732|NCT02726334|"     The purpose of this study is to determine the maximum tolerated dose (which will be the dose     recommended for a Phase 2 study), safety, tolerability and pharmacokinetic profile (study of     movement of the drug within the body, including absorption and distribution) of the study     drug, BNC101 when administered intravenously as a single agent or in combination with     chemotherapy in patients with metastatic colorectal cancer who have failed at least 1 or 2     lines of chemotherapy.   "
42733|NCT02726321|"     Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with     alterations in the sensitivity of carotid and subclavian baroreceptors.      Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the     autonomic modulation of the heart rate variability (HRV).      Methods: This is a prospective cross-sectional study. The carotid IMT is determined by B-mode     and duplex ultrasonography. The cardiovagal function was determined through linear and     nonlinear measures of HRV. Linear regression models, adjusted for demographics,     comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will     be used to evaluate the association between HRV parameters and carotid IMT.   "
42734|NCT02726308|"     Postoperative nausea and vomiting (PONV) are the most common and distressing side effects     following Laparoscopic cholecystectomy   "
42939|NCT02723617|"     The objective of this study is to evaluate the effects of different quantities of lean beef     (0.5, 2.5, 5.5 oz/day) on lipids, lipoproteins, and vascular health endpoints in the context     of a modified Mediterranean dietary pattern that is representative of foods typically     consumed in the United States.   "
42735|NCT02726295|"     Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment     remains challenging. There exist effective pharmacological therapies for chronic     constipation, however, many patients do not well respond to current medications. Evidence     suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic     constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic     constipation, there are limited data regarding the efficacy of E.coli Nissle 1917 (Mutaflor®)     in these patients. Therefore, this study aimed to investigate the efficacy of E.coli Nissle     1917 (Mutaflor®) in patients with chronic constipation.   "
42736|NCT02726282|"     To explore how a clinical sample of patients with thyroid nodules (men and women) with no     history of thyroid cancer would make decisions about treatments based on different     terminology used to describe papillary thyroid cancer (with and without the cancer term).   "
42737|NCT02726269|"     The goal of this trial is to compare the non-inferiority efficacy and safety of two different     treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily     (PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g twice daily     (CLA, reference), each during 10 days, over Helicobacter Pylori (HP) eradication. Both     schemes will be tested in treatment-naive patients, with biopsy-based diagnosis for HP     infection. One month after finishing each treatment, C13-urea breath testing will be required     to verify HP eradication. Biopsies will also be taken to identify Clarithromycin-resistance     mutations in HP strains by fluorescence in situ hybridization (FISH).   "
42738|NCT02726256|"     The prevalence of type 2 diabetes has consistently increased and type 2 diabetes can cause     many types of vascular complications. Diabetes develops due to glucose intolerance. Early     detection and intervention in the stage of glucose intolerance makes it afford to prevent     overt diabetes and its complications. This study was designed to make a cohort of korean     patients with glucose intolerance to construct a long term database about clinical     characteristics of these patients.   "
42739|NCT02726243|"     Build a collection of fecal microbiota in order to determine the characteristics of gut     microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).   "
42740|NCT02726230|"     Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and     child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to     build front line health worker (FLW) capacities and reach to communities and households, as     well as to strengthen public health facilities and quality of care to increase maternal and     neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal     districts in western and central Bihar.received Ananya, while 30 districts did not. Data were     collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months     at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to     assess Ananya effects on quality and quantity of FLW home visits, postnatal health behaviors,     and among older infants/toddlers, complementary feeding and vaccination. Difference in     difference analyses were used to assess Ananya outcome effects in this quasi experimental     study.   "
42741|NCT02726217|"     CareSmarts is a theory-driven behavioral intervention designed to improve self-care among     patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c>8%), through multiple     mediators, including cuing, education, self-efficacy, social support, and health beliefs.     Individuals will be randomly assigned with equal allocation to either the CareSmarts     intervention or to usual care for 6 months.   "
42742|NCT02726204|"     The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can     assist task performance during 3D arm movement tasks under various experimental conditions in     healthy individuals and patients with stroke. This study is designed to test motor learning     with the robotic rehabilitative device CAREX under three conditions in healthy subjects and     subjects with post-stroke hemiparesis.   "
42744|NCT02726178|"     Background: Inflammation may depress respiration in neonates. The aim of this study was to     establish a link between post-immunization inflammation and cardio-respiratory events (CRE).      Methods: Randomized double-blind controlled study of infants born <32 weeks gestation     receiving the 2 months vaccine. Infants were randomized into an ibuprofen treatment group and     a placebo control group. C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels were     assessed before and after immunization. CRE were recorded for 72 hours. Heart rate     variability (HRV) was assessed by polysomnography.   "
42745|NCT02726152|"     The investigators propose a study to compare two methods of closing the stump of the appendix     during an emergency excision of the appendix using a keyhole approach. One similarly designed     study has been undertaken in another institution but there were not enough patients recruited     to the study to allow meaningful conclusions to be drawn.      Any patient over the age of 16 years whom the investigators suspect to have acute     appendicitis will be considered for recruitment to the study. During their exploratory     keyhole surgery, if the surgical team feels that excision of the appendix is indicated then     the patient will be randomly allocated to either polymer clips or endoloops to the part of     the procedure where the stump (base) of the appendix is closed.      The main aim is to determine if polymer clips shorten the duration of the operation. The     investigators will also determine if there is a difference between the rates of     complications, the time spent in hospital and the number of times the participants had to be     readmitted to hospital within 30 days.   "
42746|NCT02726139|"     Commercial one and two-stage factor VIII assays may not detect some clinically significant     inhibitor antibodies. The purpose of the proposed study is to standardize and validate a     platelet-based factor VIII activity assay with greater sensitivity to clinically important     inhibitory antibodies. Investigators will evaluate the platelet-dependent inhibitory activity     vs. conventional inhibitory activity in stored patient plasmas and correlate to bleeding     histories   "
42864|NCT02724592|"     Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries.     Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early     carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect     of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.      Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second     permanent molars at eruption will be allocated in this randomized, controlled, single blinded     study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.   "
42747|NCT02726126|"     Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber     laminectomy under general anesthesia were included in this randomized controlled double-blind     study. Patients were randomly divided into 3 groups 25 each, C group patients received     transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of     postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative     monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory     depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours     postoperatively. Postoperative Patient`s and Surgeons` satisfaction, Intraoperative bleeding     and plasma cortisol (µg / dl) postoperatively were also assessed.   "
42748|NCT02726113|"     The study population will be 80 adult men who have been diagnosed with prostate cancer who     are scheduled to have their prostate surgically removed at either the Medical University of     South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men     will be randomized into two groups: one group will take vitamin D3 supplementation and the     other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of     the study and again after two months, just prior to the surgical procedure (prostatectomy).     Prostate tissue will be obtained from the surgical procedure and studied for the effect of     vitamin D on the prostate cancer cells.   "
42749|NCT02726100|"     It's a community-based parallel-arm cluster Randomized Controlled Trial (RCT). An interactive     mobile health management system will be developed to support lay family health promoters and     healthcare staff to improve clinical outcomes for family members with Type 2 Diabetes     Mellitus (T2DM). 2,000 participants from 80 communities will be chosen from an urban (Beijing     province) and a rural setting (Hebei province).   "
42750|NCT02726087|"     This is a single-center, single-blind, all comer, randomized controlled trial. Patients     scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at Virgen de la     Victoria Universitary Hospital, Málaga, Spain, will be eligible. Ninety-six patients will be     randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full     sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta     error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life     EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).   "
42751|NCT02726074|"     This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of     perampanel added to monotherapy for partial onset seizures with or without secondarily     generalized seizures (total seizures).   "
42752|NCT02726061|"     The investigators have developed an interactive, multimedia computer-based depression     treatment program (Dartmouth Research Problem Solving Therapy; DrPST). DrPST is based on an     evidence-based psychotherapy called Problem Solving Therapy in which depressed patients     identify problems in their lives and work through a structured format for solving these     problems. The investigators have subjected DrPST to Phase 1-3 feasibility, acceptability and     efficacy trials which have been positive and without adverse events. The purpose of the     current study is to make DrPST available through the Employee Assistance Program (EAP) at     Dartmouth-Hitchcock Medical Center and the Faculty and Employee Assistance Program (FEAP) at     Dartmouth College in order to assess the feasibility, acceptability and effectiveness under     naturalistic conditions.   "
42753|NCT02726048|"     This investigation is designed to evaluate the performance, comfort and ease of use of the     Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy   "
42754|NCT02726035|"     The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in     adolescents and adults of normal intelligence.   "
42755|NCT02726022|"     Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment     with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this     non-interventional, open-label study. The primary aim is to evaluate quality of life     according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the     Greek population.   "
42756|NCT02726009|"     The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate     long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced     hormone-dependent prostate cancer requiring androgen deprivation therapy.   "
42757|NCT02725996|"     To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment     group(Control group)' in patient undergone curative resection(RFA or operation) for     hepatocellular carcinoma in China.   "
42760|NCT02725957|"     This will be a double-blind, randomized, placebo-controlled, single ascending dose study     performed in healthy subjects.      The study will include up to four escalating dose cohorts with eight (8) subjects in each     cohort.      In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV     administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2).      All subjects, regardless of their treatment arm assignment, will undergo the same evaluations     and will receive the study drug at the clinic. Each subject will continue to be followed for     one week post dosing.   "
42761|NCT02725944|"     PROACTIA is a prospective, event-driven observational study. It aims to propose a composite     scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in     patients after acute cryptogenic stroke and transient ischemic attack (TIA).   "
42762|NCT02725931|"     The aim of this study is to investigate whether providing feedback on physical activity (PA)     levels to patients with Chronic Obstructive Pulmonary Disease (COPD) is feasible and enhances     daily PA and health-related outcomes during pulmonary rehabilitation (PR).      Patients will participate in a 12-week PR program and a PA-focused intervention. Patients'     daily PA will be monitored during the first (W1), seventh (W7) and 12th (W12) weeks of the PR     program using the activity monitors GT3X+ (ActiGraph, Pensacola, FL) and feedback will be     given to them in the following weeks. Each participant will also receive individualised     recommendations to improve or maintain their PA levels, based on the results of the previous     week.      It is expected that, by receiving individualised feedback and goals regarding their PA levels     during the PR program, patients with COPD will become more active and improve their     health-related outcomes.   "
42940|NCT02723604|"     The overall purpose of this study is to examine the efficacy of prophylactic low-level laser     therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients     receiving combined modality therapy consisting of chemotherapy and radiation therapy for head     and neck cancer.   "
42763|NCT02725918|"     The study is a prospective, multi-center, open-label, randomized, and controlled phase II     clinical trial. The investigators hope to figure out the better chemotherapy regimen for the     post-EGFR-TKI failure setting. The primary objective of this trial is to compare     progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin and     single-agent pemetrexed treatment arms.      The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease     progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2     arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500     mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged     by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as     maintenance until progression or intolerable toxicities. Patients in arm B will receive     pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.   "
42764|NCT02725905|"     Eight U.S. medical schools will be participating in the study: Weight Management Counseling     in Medical Schools, also known as MSWEIGHT. This is a five-year randomized controlled trial     (RCT) designed to compare the efficacy of two approaches to learning weight management     counseling: 1)traditional education (TE) and; 2) multi-modal educational intervention (MME).      The study aims are to refine and compare the efficacy of MME to TE on observed student weight     management counseling skills measured through the primary outcome, the Objective Structured     Clinical Examination (OSCE).   "
42765|NCT02725892|"     National, prospective, multicentric, non-interventional registry-based study, conducted among     oncologists, pulmonologists in community and university hospitals, from the public sector in     Algeria.      The study will collect information on the characteristics, and lung carcinomas patterns of     patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.   "
42766|NCT02725879|"     Thyroid hormone (TH) and fibroblast growth factor 21 (FGF-21) are reported to share common     metabolic pathways and underlying mechanisms in terms of energy balance, thus affecting both     thermogenesis and resting metabolic rate (RMR). Although FGF-21 levels has been studied in     children and adolescents regarding obesity, body composition and insulin resistance, data in     children and adolescents diagnosed with Hashimoto's thyroiditis are lacking. Therefore, the     purpose of this study is to measure the RMR in children and adolescents diagnosed with     clinical hypothyroidism due to thyroiditis Hashimoto just before starting levothyroxine     treatment and after six months achieving an euthyroid state, and to detect any association     between serum FGF-21 levels and RMR.   "
42767|NCT02725866|"     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)     has been shown to be safe and effective in randomized controlled clinical trials with strict     inclusion and exclusion criteria under well controlled conditions.      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±     RBV, used according to local label, under real world conditions in Greece in a clinical     practice patient population.   "
42768|NCT02725853|"     Many people who have had a stroke have problems recovering the use of their affected arm and     these problems may persist for a long time. The investigators' research will test new ways to     boost recovery by using non-painful brain stimulation together with training of arm movements     using basic science principles. The training program will be done using the latest technology     in rehabilitation such as virtual reality and robotics. The investigators will compare three     groups of patients who have had a stroke. Each group will receive different combinations of     brain stimulation and arm training. Another aspect of this proposal is that the investigators     will do the same training programs in three different countries - Canada, Israel and India.     In this way, the investigators will combine knowledge and skills to create training programs     that can be applied anywhere in the world and that are not necessarily limited to high-income     countries. Also, by combining expertise, the investigators will help to build the capacity to     do research in India, a middle-income country that has great potential to contribute new     knowledge to rehabilitation medicine.   "
42781|NCT02725684|"     The purpose of this study is to assess whether the use of genomics can help identify patient     specific treatment choices in cancer. In order to test this, the investigators plan to use     genomic sequencing technology to identify patient specific mutations in glioblastoma     multiforme (GBM) as compared to normal cells to identify mutations. Further analysis will     identify potential treatment targets and whether there are any drugs that could be used for     these particular mutations. Follow up clinical data will be assessed to see if this     individualized method of choosing treatment options can improve clinical outcomes in patients     with GBM.   "
42769|NCT02725840|"     Through improved early detection and treatment, the number of long term breast cancer     survivors continues to increase. There are now 2.8 million breast cancer survivors in the     U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive     radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence.     Even with advanced radiation techniques for dose conformality to minimize exposure of the     highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical     pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early     diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for     the long term care of these survivors.      The investigators' goal is to better identify breast cancer patients at high risk for     experiencing severe pulmonary toxicity requiring medical intervention, provide a means to     identify toxicity early on, and tailor treatment and/or early intervention on a per-patient     basis.   "
42770|NCT02725827|"     This is a randomized-controlled trial evaluating the effect of the use of hyaluronan     (HA)-enriched embryo transfer medium on the live birth rate in women undergoing frozen-thawed     embryo transfer. For half of the women, hyaluonan-enriched medium will be used as embryo     transfer medium. For the other half of women, control will be used.   "
42901|NCT02724111|"     The investigators aim to investigate operating conditions, postoperative recovery and overall     satisfaction of surgeons between deep neuromuscular blockade (NMB) group and restricted NMB     group during spinal surgery under general anesthesia. The investigators hypothesize that this     study can present good surgical conditions, postoperative recovery outcomes and overall     satisfaction of surgeons in deep NMB group, thereby proving the advantages of deep NMB as     well as flaws of restricted NMB in spine surgeries.   "
42771|NCT02725814|"     Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures,     such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for     reducing babies' pain during painful procedures. Unfortunately, sucrose is not used as often     as it could be to reduce babies' pain. This may be due to lack of certainty about the least     effective amount of sucrose to use and concerns about the long-term effects of repeated use     of sucrose on infant development. Factors within the hospital units where babies receive care     may also influence caregivers' decisions to use sucrose. In this research the investigators     will conduct two main studies. In the first study the investigators determined the lowest     amount of sucrose needed to manage babies' pain effectively. In the second study the     investigators will explore (a) if this amount of sucrose can manage pain when it is used     repeatedly for all painful procedures while the baby is hospitalized and (b) whether     consistent use of sucrose influences the development of babies when they are 18 months old.     During the second study, the investigators will also examine the hospital units where the     babies receive care. They will look at staff support for research, time and resources and     other factors that promote and prevent sucrose use. The results of these studies will be used     to determine the best management of babies' pain during painful procedures in hospitals to     achieve the best outcomes.   "
42772|NCT02725801|"     Appropriate patients undergoing going immediate breast reconstruction with tissue expanders     following mastectomy will be randomized to receive one-port or two-ports tissue expanders.     Their clinical course, complications, and outcome will be analyzed.   "
42773|NCT02725788|"     A multi-center randomized control trial comparing the dressing wear times of two different     transparent film dressings when used to secure peripheral intravenous catheters of     hospitalized adult patients.   "
42774|NCT02725775|"     This study is a 10-week intervention study to examine the acute and chronic effects of daily     intake of a 100 % orange juice drink vs control drink on cognitive performance. The study     aims to determine if there are any benefits of whole orange juice intake on cognitive     performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an     improvement in performance at week 10).   "
42775|NCT02725762|"     The purpose of this research study is to determine if photobiomodulation is an effective     treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the     disease.   "
42776|NCT02725749|"     Objectives: The objective was to compare low level laser therapy (LLLT) therapy versus low     LLLT therapy in combination with an exercise or exercise only on pain, range of motion (ROM),     functionality, and activity limitation in patients with subacromial impact syndrome.      Design: Randomized and placebo-controlled clinical trial.      Setting: The setting for the study was the Municipal Clinic of Barueri, São Paulo, Brazil.      Participants: 60 patients with subacromial impact syndrome were randomly assigned in three     groups.      Interventions: Group I, experimental (n=21) treated with low level laser therapy and     exercises; Group II, experimental (n=21) treated with exercises; and Group III, experimental     (n=18) treated with low level laser therapy. Laser used were GaAs (904 nm, 60 mW), in     continuous emission. The participants received application of laser three times or week for     eight weeks, on 9 shoulder points (3 Joules/point) per session.      Main outcome measures: Visual Analogic Scale (VAS) score, Shoulder Pain and Disability Index     (SPADI), goniometer, Modified-University of California at Los Angeles Shoulder Rating Scale     (UCLA), recorded before and after treatment.   "
42777|NCT02725736|"     To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of     calcium channel blockers (Nifedipine) among women with multiple gestation who present with     threatened preterm labor.   "
42778|NCT02725723|"     Spinal stenosis is a prevalent diagnosis, which is handled in a heterogeneous manner by     clinicians. Moreover, when using steroidal epidural injections, successful treatment is     currently defined as the satisfaction of the patient from the treatments, a subjective and     non-quantifiable indicator.      In this experiment, the investigators aim to evaluate thermographic images as an objective     method for assessing the efficacy of steroidal epidural injections, the most common invasive     treatment for pain associated with spinal stenosis   "
42779|NCT02725710|"     This is a randomized controlled double-blind placebo-controlled trial evaluating the impact     of gabapentin given preoperatively on perioperative pain scores for women receiving uterine     aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a     prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the     abortion setting.   "
42780|NCT02725697|"     The purpose of this observational study is to investigate the treatment of complaints     following sports injuries with Traditional Chinese Medicine by therapists in Switzerland.   "
42808|NCT02725333|"     Background: There is no evidence that shoulder stabilization effectively corrects the     glenohumeral translation in unstable shoulders, explaining residual apprehension in certain     patients. The purpose of this study was to analyze the effect of surgical stabilization on     glenohumeral translation.      Methods: Anteroposterior and superoinferior translations were assessed in patients, before     and after shoulder stabilization, through a dedicated patient-specific measurement technique     based on optical motion capture and computed tomography.   "
42782|NCT02725671|"     Cardiogoniometry is a technique to process and evaluate vectorcardiography from regular ECG     acquisitions. Vectorcardiography has a long tradition in cardiology for providing     comprehensive information on myocardial function and integrity. In recent years, computer     assisted analysis has allowed automated interpretation of vectorcardiography with promising     results in comparison to standard ECG for identifying patients with coronary heart disease.     This study aims to investigate the utility of cardiogoniometry for noninvasively identifying     patients who are at risk from coronary heart disease.   "
42783|NCT02725658|"     The purpose of this research study is to help us learn if an experimental imaging device     called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during     chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the     end of the treatment. This study will also help us understand the biological reason for how     DOSI works.   "
42784|NCT02725645|"     The purpose of the present study is to analyze the influence of four backpack loading     conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck     and lumbar muscles of elementary school children.   "
42785|NCT02725632|"     This study is designed to test whether SCN5A mRNA processing is altered in OSA patients,     which may contribute to their increased arrhythmic risk, and whether processing of SCN5A mRNA     is modulated by CPAP treatment.      Specific aims:        1. Compare sodium channel splicing variants in mild, moderate, or severe OSA patients at          baseline to at 1 month after CPAP treatment. In addition, the baseline splicing variants          of SCN5A in the OSA patients will be compared to an age-matched control group.        2. Hypoxia-associated upstream regulators of SCN5a mRNA splicing, Hypoxia-inducible factor          1-alpha (HIF-1α), RNA Binding Motif Protein 25 (RBM25) and LUC7-Like 3 Pre-MRNA Splicing          Factor (LUC7L3), will be examined in OSA patients before and after 1 month of CPAP          treatment.   "
42786|NCT02725619|"     This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus     Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and     moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in     levels of activity/functional connectivity within the neural circuits involved in emotion     regulation and social perception. Matched typically developing children without autism and/or     anxiety will be scanned twice, 16 weeks apart, to enable interpretation of treatment-evoked     change relative to normative development.   "
42787|NCT02725606|"     The purpose of the present trial is to evaluate the safety, tolerability and     pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast     cancer patients. Moreover, the efficacy will be assessed preliminary.   "
42788|NCT02725593|"     A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the     comparative efficacy and safety between dapagliflozin and Placebo.   "
42789|NCT02725580|"     The proposed clinical trial is the first human, open-label, single dose study of     self-complementary AAV9 carrying the CLN6 gene delivered one-time intrathecally inserted by a     lumbar puncture into Batten CLN6 Disease subjects. One cohort of patients with Batten CLN6     Disease, with confirmed diagnosis, will undergo gene transfer. A minimum of six patients will     be enrolled into the cohort.   "
42790|NCT02725567|"     The purpose of this study is to evaluate the safety of ivacaftor treatment, and PK of     ivacaftor and metabolites in subjects with cystic fibrosis (CF) who are <24 months of age at     treatment initiation and have a CF transmembrane conductance regulator (CFTR) gene gating     mutation   "
42791|NCT02725554|"     The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve     Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo     System utilizes a minimally invasive procedure to implant a neurostimulator. This technology     includes an octopolar electrode array stimulator with an embedded receiver. The energy source     is a small, external, rechargeable transmitter, which is worn by the patient. The StimRelieve     Halo System eliminates the implantable pulse generator, which has been the most common reason     for reoperation or discomfort with existing devices.      For this study, all subjects will be randomized at enrollment into either a delayed or     immediate continuation group. The immediate continuation group will immediately continue with     the stimulation therapy after the 30-day trial period and will be monitored for a total of 12     months. The delayed activation group will have their device turned off after the 30-day trial     period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed     activation group will have their devices reactivated.      All subjects will immediately receive the permanent stimulator(s). The permanent stimulators     can easily be removed if non-responders are identified. The wireless technology eliminates     the need for externalized extensions, IPG's and thus reoperation. Additionally the outcome is     highly dependent on placement of the stimulators. By eliminating the need for a staged trial,     infection rates and incidence of pocket pain will decrease.      In this study, subjects will undergo a 30-day trial in order to demonstrate effectiveness.     Immediate activation of all devices will be done in the post-op period based on sensory     response and subject comfort. Subjects will be seen at 14-days post-implant to assess patient     compliance with the device, assess clinical response and to adjust programming parameters if     not responding. Subjects will be seen at 1 month post-implant and headache diaries and     questionnaires will be reviewed. Subjects not responding to the therapy by at least a 30%     reduction in headache days will be deemed non-responders and will be withdrawn from the study     and can choose to have the device removed. After the trial period, all responders will follow     their random assignment determined at enrollment (delayed or immediate continuation). All     subjects will be monitored for a total of 13 months. Adverse events will be monitored     throughout the study.   "
42792|NCT02725541|"     This is an open label, neoadjuvant phase II study to evaluate the objective response,     toxicity, and safety of trastuzumab emtansine in patients with newly diagnosed HER2-equivocal     breast cancer. Trastuzumab emtansine at a dose of 3.6 mg/kg will be intravenously     administered every 3 weeks for a total of 6 weeks. Patients who achieve a partial or complete     response after the 6-week treatment (responders) will continue on trastuzumab emtansine for     an additional 12 weeks.   "
42793|NCT02725528|"     This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both     the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus     limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms     of improved quality of life and reducing recurrence of the disease without serious     complications. Since collagenase injections are costly it is also important to know if this     novel intervention is cost-effective from the patient, Ministry of Health and societal     perspectives.   "
42794|NCT02725515|"     The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus     Erythematosus (SLE) disease activity improvement achieved by a brief course of     disease-suppressing steroid therapy   "
42795|NCT02725502|"     Type 1 diabetes is an autoimmune disorder characterized by beta cell destruction resulting in     insulinopenia. Currently it is being treated with insulin. Dipeptidylpeptidase inhibitors     (DPP4 inhibitors e.g. linagliptin & sitagliptin) has been used for type 2 diabetes mellitus     (T2DM) traditionally. Previous studies has shown that it is also effective in type 1 diabetes     mellitus (T1DM), but the mechanism of action not well understood. This study will evaluate     possible mechanism of action of linagliptin in T1DM patients.   "
42796|NCT02725489|"     In this study, the researchers want to learn more about Vigil and durvalumab in advanced     women's cancers: 1) how much of Vigil in combination with durvalumab (MEDI4736) can be given     with an acceptable level of side effects, 2) the effects of Vigil and durvalumab in     combination (good and bad), 3) if Vigil will cause changes in cancer cells that may help     durvalumab attack the cancer, and 4) whether or not Vigil and durvalumab will slow your     cancer or stop your cancer from getting worse.      Combining Vigil with durvalumab will allow the former to induce (or increase) the     infiltration of activated T cells into tumors, and in addition, to enhance PD-L1 (programmed     cell death ligand 1) expression. Consequently, the response rate of historically low or     un-responsive cancer will be increased with the combination of Vigil and anti PD-L1.   "
42797|NCT02725476|"     The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related     Disease (RD) activity   "
44014|NCT02709564|"     The aim of the study is to compare the effectiveness of sublingual administered prostaglandin     E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to     decrease blood loss during and after the operation.   "
42798|NCT02725463|"     Although cochlear implants can restore hearing to individuals who have lost cochlear hair     cell function, there is no adequately effective treatment for individuals suffering chronic     imbalance, postural instability and unsteady vision due to loss of vestibular hair cell     function. Preclinical studies have demonstrated that electrical stimulation of the vestibular     nerve via a chronically implanted multichannel vestibular prosthesis can partially restore     vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility     study of a multichannel vestibular implant system will evaluate this approach in up to ten     human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other     causes of inner ear dysfunction.   "
42799|NCT02725450|"     The main purpose of this study is to ascertain whether the application of Motor Imagery     together with normal practice improves fine motor skills in disabled individuals.   "
42800|NCT02725437|"     The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability,     and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one     of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.   "
42801|NCT02725424|"     This is a randomized,phase II,open-label study, The purpose of this study is to determine the     optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer     according to their Her-2 expression status.      The primary endpoint of this study: pathology response rate the second endpoints of this     study:pathology complete response rate R0 resection rate Progression-free survival ( PFS)     Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse     event(AE)   "
42802|NCT02725411|"     This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5     mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary     objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg     administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the     long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7     administrations).   "
42803|NCT02725398|"     Gastrointestinal cancer has developed into a serious health problem in China. 80%-90%     patients were detected at middle and later stage. The five-year survival rate for advanced     cancer patients is less than 10%. The main reason of the bad clinical diagnosis and treatment     is that the present technical method is difficult to achieve early diagnosis. Endoscopy with     biopsy is still the main method for confirming gastrointestinal cancer. But it is limited to     identify early tumors and it leads to the low diagnostic rate of early tumors and the poor     overall therapeutic effect.      Confocal laser endoscopy (CLE) can obtain pathologic information of lesion in real time and     improve the diagnostic rate of early tumors. Probe-based confocal laser endomicroscopy(pCLE)     is a new technology recently. Since its laser probe is applicable to all conventional     endoscopes, pCLE greatly increased its clinical application. However, gastrointestinal     motility has greatly influence on pCLE imaging quality and inspection effect owing to the     poor stability of the small probe manipulation. Scopolamine (654-2, in China) is clinically     used to inhibit bowel peristalsis, but its effect is still not ideal and its side effects are     common.   "
42804|NCT02725385|"     This research trial studies stress and coping in caregivers of younger patients with cancer.     Learning how caregivers of children with cancer experience and cope with chronic stress may     help to develop effective programs for reducing caregiver stress.   "
42805|NCT02725372|"     Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety,     tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in     symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2   "
42806|NCT02725359|"     Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human     body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain     and discomfort for the patients.      a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to     their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative     and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant,     sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity     and has recently been used to treat musculoskeletal pain conditions.      Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary     advancement to improve success and safety of regional anesthesia. Analgesic effect of US     guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has     not been reported yet.      The aim of this study was to evaluate the analgesic effect of preemptive oral single dose     tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The     investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores,     analgesic consumption, analgesic related side effects.   "
42807|NCT02725346|"     A computer-assisted solution for acromioplasty is presented. The software allows surgeons to     better plan the surgical procedure by visualizing dynamic simulation of the patient's     shoulder joint during everyday activities. Impingements are dynamically detected and the     exact location and amount of bone to be resected is precisely computed. As a result, the     success of the acromioplasty does not only rely on the surgeon's experience or previous     recommendations, but on quantitative data. Although the clinical validation of this 3D     planning support is currently under evaluation, it may allow to recover more effectively     postoperative joint mobility, to get a better relationship with pain and a better healing     rate of the rotator cuff tendons.   "
42809|NCT02725320|"     The overall purpose of this work is to use a prospective cohort study to examine     patient-specific but shoulder-extrinsic factors and how they influence the results of rotator     cuff surgery. There are undoubtedly many factors that play a role in patient outcome,     however, this project will focus on three: the effect of gender on outcome, the effect of     mood disorders and coping style on outcome, and the effect of patient height and reach on     outcome after rotator cuff surgery. It is hypothesized that these factors will have a     significant influence over outcomes.   "
42810|NCT02725307|"     This study evaluates a novel noninvasive method to dynamically monitor the effect of     percutaneous transluminal angioplasty on arterial pulse wave   "
42955|NCT02723409|"     The primary objective of the study will be to determine which of five traditionally used     umbilical reconstructive techniques offers superior aesthetic results. Additionally,     secondary objectives of post-operative complications such as hypertrophic scar formation will     also be measured.   "
42811|NCT02725294|"     This observational study will examine the care-seeking behaviors of Veterans with chronic     obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack     of access to care leads to delays in getting care for COPD exacerbations. Participants will     complete a baseline in-person visit and receive calls every two weeks for one year to monitor     for COPD exacerbations. Detailed information about each exacerbation and time to care will be     obtained. A sample of participants and their caregivers will participate in more in-depth     interviews. Approximately half the participants will also use a remote inhaler monitor to     record their albuterol inhaler use to see if this approach can identify early exacerbations.     Results from this study will be used to develop an intervention that will assist Veterans in     the early identification, evaluation, and treatment of exacerbations, and will be integrated     with the VA primary care team.   "
42812|NCT02725281|"     Investigators observed that during the Extracorporeal Shock Wave Lithotripsy (ESWL)     non-pharmacological methods used for reducing the level of the pain and anxiety among the     patients with the urinary stones are not sufficient and the effectiveness of these methods is     controversial. There are very few studies, which investigated the effects of music on the     pain and anxiety during ESWL. In addition, any randomized clinical trial related to the use     of stress ball for relaxation and distraction on the reduction of pain and anxiety during     lithotripsy has not been found in the relevant literature. Investigators also evaluated that     further evidence-based studies are necessary. Thus, investigators aimed to investigate the     effectiveness of stress ball and music for reducing the pain and anxiety of the patients     during ESWL in this study.   "
42813|NCT02725268|"     The primary purpose of this study is to determine if MLN0128 in combination with weekly     paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.   "
42814|NCT02725255|"     Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to     IPs is greatest in school-age children who typically have the highest burden of infection. In     2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of     antihelminthic drugs to deworm children in developing countries. Though initially effective,     there is concern that MDA might not be sustainable over extended periods especially     considering the large children populations and the high frequency of dosing. Further, the     MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to     favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for     alternatives that are not only affordable and sustainable but easier to implement in the long     term with a minimal chance of development of resistance. The investigators propose to develop     and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that     have been shown to have antihelminthic properties. The investigators intend to evaluate its     efficacy when given through school feeding programs and compare the outcome with albendazole-     the recommended MDA agent for deworming school children. The investigators will design and     formulate the product and test it among children in three primary schools in Western Kenya.   "
42815|NCT02725242|"     This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5     µg/d in the period of step down in well controlled asthmatic patient.   "
42816|NCT02725229|"     the objective of the present study was to compare the efficacy of TENS and parasternal block     with local anesthetic infiltration in relieving pain during the first 24 h period following     median sternotomy.   "
42817|NCT02725203|"     A two-armed, cluster randomized controlled trial will be conducted comparing the Activate     intervention with care as usual in 31 general practices in the Netherlands, in which     approximately 279 patients at risk for cardiovascular disease will participate. The Activate     intervention focuses on increasing physical activity and is developed using the Behavior     Change Wheel (BCW). The activate intervention consists of four nurse-led consultations     divided over a 3-months period. Primary outcome is the level of physical activity measured     with an accelerometer. Potential effect modifiers are age, body mass index, level of     education, social support, depression, patient-provider relationship and baseline amount of     minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months     of follow up.      Nurses will be trained in delivering the intervention by a one-day training and coaching     sessions supervised. A process evaluation will be conducted.   "
42818|NCT02725190|"     The purpose of this study is to assess the impact of sleep deprivation on subjective     inspiratory endurance in healthy subjects.   "
42819|NCT02725177|"     Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with     active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)   "
42820|NCT02725164|"     Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx     during airway surgery. Investigators sought to measure the concentrations of anesthetic gases     that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed     tracheal tubes during spontaneous and controlled ventilation.   "
42821|NCT02725151|"     Known before diagnosed heart failure and used diuretic therapy patients will be admitted in     this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be     used for management of Acute Heart failure therapy. And investigators will calculation     correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers     will not interfere to standard recommended treatment protocol, researchers will correlated     the urine amount and changed vital signs with therapy with Vena cava inferior diameter.   "
42822|NCT02725138|"     We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in     the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in     this double blind, placebo controlled, randomized trial.   "
42823|NCT02725125|"     This single-arm, multicenter Phase 2 trial will treat the patients who have relapsed or     refractory stomach cancer with an infusion of the patient's own T cells that have been     genetically modified to express a chimeric antigen receptor(CAR) that will bind to tumor     cells that express the EPCAM protein on the cell surface.The study will determine if these     modified T cells help the body's immune system eliminate tumor cells.The trial will also     study the safety of treatment with CAR-T, how long CAR-T cells stay in the patient's body and     the impact of this treatment on survival.   "
42824|NCT02725112|"     This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6     sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence)     healthy male and female subjects who, at the time of screening, are between the ages of 18     and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be     replaced at the Sponsor's discretion. Screening activities will be completed within     approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6     treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6     periods with subjects receiving single doses of pregabalin ER 330 mg target release rate     tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate     tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and     pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments     will be administered following a 600- 750 calorie, 30% fat evening meal.   "
42825|NCT02725099|"     To examine chewing versus traditional oral administration of ticagrelor in ST-elevation     Myocardial Infarction (STEMI) patients on platelet reactivity.   "
42826|NCT02725086|"     A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare     Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of     Leucostim® and Neupogen® in Healthy Adult Volunteers   "
42827|NCT02725073|"     To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and     a flexible laser probe in locally advanced hilar cholangiocarcinoma.   "
42828|NCT02725060|"     The purpose of this study is to see if some people with postural tachycardia syndrome (POTS)     have higher levels of immune proteins (autoantibodies) directed against receptors of the     autonomic nervous system, and if these autoantibodies make a difference in their POTS     symptoms. The investigators also want to see if the levels of these autoantibodies stay the     same over time.   "
42829|NCT02725047|"     The purpose of this study is to verify the effect of cryotherapy in pain control, function     and quality of life in individuals with knee osteoarthritis.   "
42830|NCT02725034|"     The purpose of this study is to assess whether high definition endoscopy with Optic     Enhancement can reduce the biopsy number needed per patient for the detection of gastric     intestinal metaplasia without the loss of corresponding diagnostic yield   "
42831|NCT02725021|"     A two armed randomized trial is evaluating the effect of the medical-student-delivered     school-based intervention Education Against Tobacco on the smoking behavior of adolescents in     7-11th grade of secondary school. The primary endpoint is the change in smoking prevalence     between the two groups.   "
42832|NCT02725008|"     Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the     pediatric emergency department.   "
42833|NCT02724995|"     This study will help the investigator understand the pathogenesis of different rare genetic     conditions and to establish database of rare genetic databases. This would ultimately help to     provide more accurate diagnosis through advanced genomic diagnostic testing and databases     established from this study. This knowledge would in turn help in the clinical management of     other affected family members and other individuals affected with similar conditions.     Understanding of pathogenesis of the disease would also enable the investigator to develop     targeted therapies for rare genetic diseases, and also to collaborate on the targeted     therapy-related clinical trials.      The investigator plans to store the results of this study in databases. These results will be     shared with other researchers or doctors, who research, diagnose or treat the individuals     with similar diseases.      The investigator will only share the data that is collected and not the biological samples.   "
42834|NCT02724982|"     Body image satisfaction and self- esteem level are important to be known among students in     order to intervene in a correct time. Body dissatisfaction is one of the factors leading to     negative self-perception, low mood, depression, and eating disorders. This may be detrimental     to students in their academic performance. However, the correlations of body image     satisfaction towards body mass index and self- esteem among university female students are     still unclear in Malaysia. Thus, the purpose of this study is to determine its relationships     among Chinese female students. university female participants will be included with     convenience sampling method. Participants will completed Ronsenberg Self- Esteem Scale and 8     items version of Body Shape Questionnaire. These 2 scales used to measure level of self-     esteem and body image satisfaction. Body mass index will be calculated from self- reported     height and weight. The data will be analysed by using descriptive and correlation methods.   "
42835|NCT02724969|"     The purpose of this pilot randomized trial is to determine the effectiveness, feasibility,     and acceptability of a mobile, semi-automated text message-based intervention (MILK) to     prevent perceived low or insufficient milk supply (PIM) among mothers without prior     breastfeeding experience. PIM is the leading cause of premature breastfeeding cessation, and     prior work shows that it is often rooted in low breastfeeding self-efficacy and     misconceptions about lactation physiology and trajectory. The MILK intervention is designed     to address PIM, as well as other common breastfeeding problems via semi-automated text     messages of prenatal and postpartum breastfeeding education and support. Messages are     time-sensitive (e.g., specific to gestational age, time since delivery) and based on the     Breastfeeding Self-Efficacy (Social Cognitive) Theory; they are also modeled from pilot work     that investigated how first-time mothers view, manage and describe breastfeeding problems.     Messages were vetted with clinical lactation experts, as well as pregnant and postpartum     women with no other children.      The MILK intervention will be trialed against a control intervention group, who will receive     general perinatal education through the national Text4Baby system. The investigators will     recruit approximately 186 healthy, pregnant women at 13-25 weeks gestation from Magee Women's     Hospital clinics and outpatient sites. Women will be randomized via computer-generated simple     randomization to the experimental or control intervention. Both groups will receive text     messages 3-5 times per week from week 25 of pregnancy through week 8 postpartum. Measured     outcomes of interest will include perceived breast milk supply, breastfeeding confidence,     maternal anxiety, breastfeeding exclusivity, and breastfeeding duration. Data will be     collected at baseline (13-25 gestational weeks), 34-36 gestational weeks, and at 1, 2, 4, and     8 weeks postpartum via online survey or telephone call. To assess the potential longer-term     impact of the intervention, breastfeeding continuation and exclusivity will be reassessed via     telephone at 6 months postpartum. Between group and group x time differences in outcome     measures will be examined graphically and via linear mixed modeling. To inform modifications     to MILK, telephone interviews will be conducted with a subset of participants in each group     to assess and compare intervention use, burdens and challenges, and suggested alterations (8     weeks).   "
42902|NCT02724098|"     The aim of this study is to investigate the pharmacokinetics of subcutaneously administered     dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously     administered dexmedetomidine will be calculated. In addition, the investigators will report     the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels,     vital signs such as systemic blood pressure, heart rate and sedation. The investigators will     also monitor the local and systemic safety and tolerability of subcutaneously administered     dexmedetomidine.   "
42836|NCT02724956|"     SIGNIFICANCE      Since the introduction of the first Laryngeal Mask Airway, the Classic LMA, the use of     Supraglottic airway (SGA) devices has experienced a remarkable evolution, and SGAs are now     routinely used in clinical anesthesia. Some of the newer SGAs have a built-in gastric     drainage channel to facilitate efflux of gastric fluid and gas, and to allow the insertion of     a gastric tube. These devices are referred to as Second Generation SGAs. One of the SGAs on     the market is the LMA Supreme which is a single-use modification of the older, reusable LMA     Proseal (Teleflex). The Supreme has a pre-curved rigid airway tube similar to the Ambu Aura     SGAs. The concept of a curved airway tube is to imitate the airway anatomy during device     placement, thus making insertion relatively easy and smooth. Due to the similarities between     the AuraGain and the Supreme, a randomized, prospective clinical study with a detailed     evaluation of the performance of these two devices will be conducted. A clinical evaluation     of device insertion and function, both as a ventilatory device and an intubation conduit,     oropharyngeal Leak Pressure (OLP), and functionality of the gastric drainage channel will be     performed in elective patients with normal airway anatomy. Moreover, a fiberoptic assessment     of the glottic view via the SGA device and signs of airway morbidity will be investigated.      SPECIFIC AIMS      The purpose of this study is to compare, the use of the Ambu AuraGain and Teleflex LMA     Supreme regarding OLP, rate of successful intubation and ventilation, ease of SGA insertion,     anatomical fit of the SGA, functionality of gastric drainage channel, and post-operative     complications.   "
42837|NCT02724943|"     A systems approach emphasizes the linkage between individual behavior change strategies and     social and physical environmental changes, which act synergistically to facilitate (or     inhibit) healthy eating and active living. The hypothesis of this study is that among     low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems     approach to child obesity will reduce body mass index (BMI) compared to primary prevention     alone.   "
42838|NCT02724930|"     This study will test the effectiveness of using enhanced facilitation strategies on     implementation of an automated Interactive Voice Response (IVR) system as a means to remotely     deliver in-home self-management support to Veterans with chronic pain. The implementation     intervention uses an enhanced facilitation approach paired with automated case finding and     direct patient outreach to encourage uptake of Cooperative Pain Education and Self-management     (COPES). A nested effectiveness study will measure pre-post differences in pain-relevant     outcomes (pain intensity, physical functioning and physical activity). The investigators will     use a stepped wedge cluster design in which clusters will be randomized to the timing of the     introduction of enhanced COPES implementation. Investigators will assess the efficacy of the     facilitation based implementation strategy by evaluating COPES uptake in the implementation     settings.   "
42839|NCT02724917|"     The purpose of this study in patients with schizophrenia is to evaluate the safety,     tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with     placebo when administered as repeated daily oral doses.   "
42840|NCT02724904|"     This research study is assessing the feasibility of reduced intensity allogeneic     hematopoietic stem cell transplantation (HSCT) as a possible treatment for relapsed /     refractory non-Hodgkin lymphoma involving the central nervous system (CNS). HSCT is the     transplantation of stem cells, usually derived from bone marrow, peripheral blood, or     umbilical cord blood.   "
42841|NCT02724891|"     Patient-reported outcomes are commonly used in healthcare. Examples include validated     symptom-based questionnaires and health diaries. In the field of Female Pelvic Medicine and     Reconstructive Surgery there are many questionnaires and diaries that have been validated for     a paper-based administration. As technology is incorporated into delivery of medical care and     research, investigators need to consider how to collect data electronically while ensuring     that this new format is equivalent to the paper questionnaires they rely on. In this study,     the investigators aim to validate a series of validated questionnaires and symptom diaries     administered via the web and smartphone for a more streamlined care for the patients.   "
42842|NCT02724878|"     This research study is studying the combination of Atezolizumab and Bevacizumab as a possible     treatment for Advanced Non-Clear Cell Kidney Cancer.   "
42843|NCT02724865|"     Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires lifelong     care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer     life expectancy and increase in weight in the general population, its prevalence is expected     to rise. Patients with mild and moderate OSA are treated primarily with an oral appliance at     present time. Different oral appliances are available, but most used is the mandibular     advancement device (MAD). This study focuses on two different types of MAD: the classic     Herbst appliance, which is attached to the mandible and the maxilla and has an iron bar to     regulate the open space; and the Somnodent, which consists of two separate splints, fixed on     the mandible and the maxilla, but has no iron bar attached.   "
42844|NCT02724852|"     This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in     HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups     who had no protective antibodies to at least one of the three viruses.   "
42845|NCT02724839|"     The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition     sessions for primary care patients aged 6 -12 years who are overweight or obese and who want     to eat healthier and be more active.   "
42846|NCT02724826|"     A randomized controlled, multicenter trial comparing qigong and exercise therapy concerning     pain intensity, treatment expectations, disability, neck movements and quality of life in     subjects with non-specific, long-term NP after three and twelve months.   "
42860|NCT02724644|"     The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the     treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as     Cellulite).   "
42861|NCT02724631|"     This is the first of three planned phases designed to evaluate the feasibility and     tolerability of TubeClear® to restore patency in occluded Pediatric Enteral Access Devices.     Based on preliminary data obtained from this phase of the study, subsequent phases will     continue to evaluate feasibility and tolerability (Phase IIA) and ultimately compare efficacy     of TubeClear® to the Children's Hospital of Philadelphia (CHOP) Standard Treatment to restore     patency in occluded Pediatric Enteral Access Devices (EAD) (Phase IIB).   "
42847|NCT02724813|"     Stroke results in long-term disability for many people, and particularly for survivors of     stroke who have cognitive impairments. However, a decreasing proportion of stroke patients     are able to access or receive publicly funded rehabilitation. The investigators have shown in     previous studies that in-person delivery of the Cognitive Orientation to daily Occupational     Performance (CO-OP) rehabilitation approach to promoting attainment of everyday life goals     has resulted in improvements in functional independence and executive function. In a small     pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI) (n=3), the     investigators found the delivery method was feasible and that participants were satisfied     with the treatment and demonstrated clinically significant improvements on personally     meaningful activities. The investigators will investigate the feasibility, preliminary     efficacy, and cost-effectiveness of delivering CO-OP in an online format to reduce disability     post-stroke. The study design is a single-blind (assessor), randomized wait-list control     trial with a one-month retention follow-up. All therapy and testing sessions will be     delivered online. We hypothesize that participants will demonstrate improvement in everyday     activities and community participation.   "
42848|NCT02724800|"     The purpose of this study is to directly compare the effectiveness of two interventions for     insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for     Insomnia (CBTI).   "
42849|NCT02724787|"     Impulsive aggression (IA) is common among Veterans with posttraumatic stress disorder (PTSD),     and PTSD is one of the most prevalent post deployment mental health conditions affecting     Afghanistan and Iraq Veterans. An inability to manage one's emotions (emotion dysregulation)     is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based     psychotherapies are two critical missions for the Veterans Health Administration.      This research supports these missions by providing a 3-session emotion regulation training     (Manage Emotions to Reduce Aggression) to Veterans in order to teach them how to manage     emotions and prepare for PTSD treatment. This is an open trail, so all Veterans who meet the     inclusion criteria will be allowed to receive the treatment. Each Veteran's level of     aggression and emotion dysregulation will be measured at the beginning and end to the     treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel     equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and     ultimately recover from PTSD.   "
42850|NCT02724774|"     Treating mothers' perinatal depressive and other mental health symptoms alone does not     prevent impaired parenting quality and adverse infant outcomes. The goal of this research is     to conduct a randomized controlled trial to evaluate the effectiveness of adding a     research-based 10-week home visiting parenting program to evidence-based mental health     treatment, to counter the pernicious effects of mothers' symptoms on parenting quality and     infant development. Participants will be English and Spanish-speaking low-income mothers who     began publicly funded mental/behavioral health treatment in pregnancy at their primary care     community health centers.   "
42851|NCT02724761|"     Our double-blinded, randomized control trial will assess the effect of nebulized racemic     epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures.     The investigators have had success in managing post-operative dysphagia in patients     undergoing ACDF with the administration of this drug. Half of the participants will review     nebulized epinephrine. The other half will receive placebo.   "
42852|NCT02724748|"     To compare the effects of an educational intervention to usual practice (no specified staff     education) on improving treatment culture and supporting team climate in staff members, which     further could reduce the need for the use of coercive methods in psychiatric care.   "
42853|NCT02724735|"     All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue     study drug and be asked to provide consent to be followed in this 6-month study, at their     final safety visit. The study will consist of an enrollment visit, followed by bi-monthly     in-clinic visits with monthly telephone visits between in-clinic visits.   "
42854|NCT02724722|"     Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present     in the public and easily contacted by children through air, foods, and skin. This study aims     to examine whether the use of family-based behavior intervention by providing simple flyers     plus face-to-face health education point-by-point and give one bag containing stainless     steel-made tableware for eating out use to study children's mothers or main-care givers can     significantly decrease melamine and phthalates exposure by measuring urinary melamine and     metabolites of phthalates (especially DEHP metabolites) in study children and their mothers     or main-care givers, when compared to those provided simple flyers only.   "
42855|NCT02724709|"     The progress in surgery of the aortic root and the evolution of transcatheter aortic valve     replacement as an alternative to surgical treatment in selected patients have refocused the     need for quantitative imaging of the aortic root during transcatheter aortic valve     replacement and valve-sparing aortic root surgery. In this study, we aim to assess the     ability of semi-automated quantitative modeling (eSie Valves, Autovalve prototype version,     Siemens Medical Solutions, USA) of the aortic valve and root in patients with clinical normal     aortic valve and root, who are indicated for both 3D transesophageal echocardiography (TEE)     and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale. Measures of     the aortic valve and root obtained by 2D TEE, 3D TEE and CT are compared, and the ability of     the semi-automated 3D TEE modeling software is tested. Given the workflow advantages of     automation, this 3D TEE approach may enhance the clinical adoption of routine 3-dimensional     imaging beyond CT.   "
42856|NCT02724696|"     RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the     objective of territorial coverage by regional expert centers and systematic discussion of     patients management at national tumor board.   "
42857|NCT02724683|"     The purpose of this study is to determine whether drainage with the usage of a fine,     patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and     effective method in the management of symptomatic malignant ascites. Complications' rate of     the procedure and patients' quality of life, nutritional status and experience on the     treatment are main endpoints.   "
42858|NCT02724670|"     MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with     prostate carcinoma.   "
42859|NCT02724657|"     To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of     asthmatic children with mouth breathing.   "
42865|NCT02724579|"     This phase II trial studies how well reduced doses of radiation therapy to the brain and     spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of     brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using     chemotherapy and radiation therapy have been shown to be effective in treating patients with     WNT-driven medulloblastoma. However, there is a concern about the late side effects of     treatment, such as learning difficulties, lower amounts of hormones, or other problems in     performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill     cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine     sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor     cells and may also reduce the late side effects of treatment.   "
42866|NCT02724566|"     Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a     glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in     healthy overweighed volunteers has been previously assessed in a phase I clinical trial     (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof     of concept to the population targeted by future innovative insulin-sensitizing therapies:     patients living with type 2 diabetes.   "
42867|NCT02724553|"     Previous studies attempted to understand the dysphotopsia phenomenon by examining intraocular     lens type, anterior capsule depth, iris-to-lens depth, lens refractive material, clear cornea     incision wounds and anterior capsulorrhexis. However, there is limited literature in     understanding haptic orientation and negative dysphotopsia; postulated theories and anecdotal     reports relate to horizontal haptic orientation and the lateralization of rays such that     light is received both in smaller width and anterior to the peripheral retina; however, no     formal studies currently exist.   "
42868|NCT02724540|"     The primary aim of this trial is to estimate the duration of hepatic progression-free     survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial     Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary     hypothesis is that chemoembolization will be nearly twice as durable as bland embolization;     thatis, the hazard ratio for HPFS will be 1.76 or better.   "
42869|NCT02724527|"     Cavosonstat (N91115) is being studied as a potential novel therapy for cystic fibrosis (CF),     and this study assesses a target population of patients who are heterozygous for F508del-CFTR     and a gating mutation that is approved for treatment with ivacaftor (G551D, G1244E, G1349D,     G178R, G551S, S1251N, S1255P, S549N, or S549R).   "
42870|NCT02724514|"     Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy.     Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been     studied. At present, no objective and standardized tools exist to evaluate breast lymphedema.      The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance     to determine if it is possible to measure the extent of the fluid in the breast.   "
42871|NCT02724501|"     This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial     cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed     world. The studies in this program span the spectrum from fruit flies to humans, as part of a     synergistic partnership that will significantly enhance our understanding of the molecular     genetic events involved in the development and progression of endometrial cancer. The     discovery of new targets for therapy, and the ability to evaluate these in subsequent     clinical trials is a significant strength of this scientific interaction, which may result in     cures for patients with primary and relapse endometrial cancer and prevention of this cancer     in women who are at high risk.   "
42872|NCT02724488|"     Two part prospective study to:        1. investigate the feasibility of performing ultra-deep sequencing of plasma derived          circulating tumor DNA (ctDNA) in individual patients with advanced solid tumors who are          currently being treated with immune checkpoint inhibitors (ICIs) and        2. obtain fresh tumor biopsies and serial blood samples to investigate the clonal evolution          of tumors under the selection pressure of ICIs.   "
42873|NCT02724475|"     Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second     most-common cause of cancer mortality. Liver resection is the first-line curative treatment     for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from     25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and     advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no     effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in     eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray     (γ-knife) can also be used to treat patients with PVTT. But there still lack of     evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view     of this, we aim to implement a randomized controlled study to find out an effective treatment     for intermediate and advanced hepatocellular carcinoma patients with PVTT based on     evidence-based research.   "
42874|NCT02724462|"     The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides     higher quit rates than the current standard smoking cessation app.   "
42875|NCT02724449|"     The purpose of this study is to obtain information concerning the safety and effective use of     a protective barrier film in patients experiencing severe incontinence associated dermatitis.   "
42950|NCT02723474|"     Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body weight)     hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the Apparent     Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation.   "
42951|NCT02723461|"     Comparing continuous intravenous oxytocin infusion with pulsatile administration of     intravenous oxytocin for augmentation of the first stage of labor.   "
42903|NCT02724085|"     This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose,     inpatient study to assess the safety, tolerability, and pharmacokinetics of TP‑271 in healthy     subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be     enrolled in this study.   "
42999|NCT02722837|"     This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir     (SOF)/velpatasvir (VEL; GS-5816) fixed dose combination (FDC) for 12 weeks in participants     with chronic hepatitis C virus (HCV) infection.   "
42876|NCT02724436|"     Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second     most-common cause of cancer mortality. Liver resection is the first-line curative treatment     for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from     25% to 45%. Transarterial chemoembolization (TACE) is the major treatment option for the     unresectable primary or secondary liver malignancies. Yittrium-90 (Y-90) is a pure     beta-emitter, without any toxic effect or immune rejection. There are ample data that support     the use of Y-90 microspheres for primary and metastatic liver tumors. The aim of our study     was to compare the clinical outcome of radioembolization with Y-90 and TACE and provide a new     strategy for the treatment of intermediate and advanced hepatocellular carcinoma with portal     vein thrombus by conduting a randomized trial.   "
42877|NCT02724423|"     This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects. Subjects     will receive a single intranasal dose of NRL-1 of either 5 mg, 10 mg, 15 mg or 20 mg and will     be based on the subject's body weight.   "
42878|NCT02724410|"     To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy     on complication rates and resource utilization following appendectomy for perforated     appendicitis   "
42879|NCT02724397|"     Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging     systems used in endoscopy which are recently developed. BLI was developed to compensate for     the limitations of NBI. BLI shows a bright image of the digestive mucosa, enabling the     detailed visualization of both the microstructure and microvasculature. However, BLI still is     not able to obtain sufficient brightness for distant lesions. The newly developed LCI system     (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength     narrow-band laser light combined with white laser light on the basis of BLI technology. LCI     makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize     a slight difference in color of the mucosa. This is a study to determine if using LCI of the     colon, rather than the usual white light on the colon, will improve the detection of flat     adenomas and serrated polyps. The polyps are called serrated because of their appearance     under the microscope after they have been removed. They tend to be located up high in the     colon, far away from the rectum. They have been definitely shown to be a type of precancerous     polyp and it is possible that using LCI will make it easier to see them, as they can be quite     difficult to see with standard white light. LCI/BLI enables endoscopists to accurately     describe the pit pattern of adenomas. By comparing White Light Endoscopy and LCI/BLI, it will     show if there is any comparable advantage to using one or the other for lesion detection and     assessment.   "
42880|NCT02724384|"     The purpose of this study is to evaluate the safety and preliminary efficacy of using     electrical plasma to treat toenail fungus.   "
42881|NCT02724371|"     The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size     Ultra High Profile (UHP-L) Breast Implants.   "
42882|NCT02724358|"     In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a     randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE     on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high     expression of Notch1.   "
42883|NCT02724345|"     To evaluate and analyse the clinical effect and application value of postoperative adjuvant     TACE treatment in patients with different expression levels of CK18 using randomized     controlled study and provide evidence for the necessity of postoperative adjuvant TACE.   "
42884|NCT02724332|"     To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with     overexpression of ASPH after radical surgery using randomized controlled study and provide a     new anti-recurrence treatment for HCC patients after operation.   "
42885|NCT02724319|"     It is well established that clopidogrel-induced antiplatelet effects is suboptimal in many     patients who are thus exposed to an increased risk of adverse cardiovascular events. Studies     have shown that genotypes of the cytochrome P450 (CYP) 2C19 enzyme, which is a key     determinant of clopidogrel metabolism, contribute to these findings. Prasugrel and ticagrelor     are alternative agents whose effectiveness is not dependent on CYP2C19 genotype. A boxed     warning on the Food and Drug Administration (FDA)-approved clopidogrel labeling warns of     reduced effectiveness in patients with the LOF genotype and recommends alternative therapies     in these patients. The availability of an assay recently approved by the FDA, SpartanRX,     which provides results within one-hour facilitates performing genetic testing as a clinical     test in real-world practice. We therefore propose to 1) examine the feasibility of     implementing CYP2C19 genotyping using SpartanRX as standard of care for patients undergoing     cardiac catheterization at UF Health Jacksonville providing the opportunity for clinicians to     embrace genotype-guided antiplatelet therapy in those who proceed to PCI and 2) determine if     CYP2C19 genotype-guided antiplatelet therapy reduces the risk for major adverse     cardiovascular outcomes after PCI.   "
42886|NCT02724306|"     The present study will use a randomised controlled trial design to investigate whether     moderate to vigorous intensity physical activity (MVPA) will affect the physiological risk     markers associated with the development of bowel cancer in individuals previously diagnosed     with a bowel polyp. The study will also investigate the effects of the programme on long-term     exercise behaviour and changes in psychological variables. A selected sample will also be     part of individual interviews at baseline and 12 months to gauge narrative accounts of     personal, psychological and sociological beliefs surrounding participation in physical     activity. The findings of this study might inform better practices for the prevention of     bowel cancer in high risk populations.      After a screening colonoscopy, eligible participants will be randomised to either an active     lifestyle programme (ALP) or a standard care group (SC). Participants in ALP will be offered     supervised exercise sessions and motivational interviewing for 6 months. Intervention     components will cease after 6 months, but participants will be followed-up at 12 months to     investigate maintenance to physical activity over the long-term. The SC will not be offered     the intervention until the end of the study. Participants in both groups will be invited for     assessments at baseline, 3, 6, 9, and 12 months. These include measurements of body     composition, cardiopulmonary fitness, physical activity behaviour, and psycho-social     variables.   "
42887|NCT02724293|"     This study compares analgesic efficacy, and safety of three different doses of peri-operative     pregabaline to placebo following radical cystectomy.   "
42888|NCT02724280|"     H. pylori infection plays a very important role in gastric carcinogenesis, progressing from     chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally     cancer. It is difficult to diagnose H. pylori related gastritis and gastric atrophy on the     basis of endoscopic findings. Histology is currently considered to be the gold standard for     detecting H. pylori infection. The reliability of detecting H. pylori infection     histologically depends on the site, number, and size of gastric biopsy specimens. The blind     biopsy sampling of normal appearing mucosa has the risk of missing pathology and sampling     errors. Most studies conclude that as well as on expertise in staining and visualizing the     bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy     sampling, and neither the original nor the revised version of the Sydney system reliably     identifies more than half the cases in patients with confirmed gastric atrophy.   "
42889|NCT02724267|"     The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of     individual therapy using randomized controlled study, in order to acquire the evidence of     evidence-based medicine and create a new program of targeted internal radiation therapy in     advanced HCC patients.   "
42890|NCT02724254|"     This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety,     tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074     5% Gel for up to 16 weeks in condyloma patients   "
42891|NCT02724241|"     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and     sham control, on sympathetic nerve activity and markers of oxidative stress.   "
42892|NCT02724228|"     This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety,     Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective     is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in     children with ACH who have completed two years of treatment in the 111-202 study.   "
42893|NCT02724215|"     In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for     sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and     worse clinical outcome early after SAH.   "
42894|NCT02724202|"     The purpose of this study is to test the safety and find the response rate of combining the     dietary supplement, curcumin, with the standard of care, FDA-approved chemotherapy drug     5-fluorouracil (5FU, Adracil) and see what effects (good and bad) that the combined     treatments have on colon cancer.   "
42895|NCT02724189|"     This pilot study will intend to assess the feasibility and acceptability of MyPreOp (online     pre-operative assessment tool). The study will aim to assess the quality of the MyPreOp     assessment in comparison to standard practice of a nurse led face to face assessment. The     investigators will also assess the acceptability of MyPreOp amongst patient participants and     staff participants.   "
42896|NCT02724176|"     Papillary thyroid cancer (PTC) is the most common subtype of thyroid cancer.      The most common site of PTC nodal metastases is the central neck, which has a reported rate     of lymph node metastases as high as 50%~70%.      Central neck dissection has important value to ensure accurate clinical staging and surgical     planning.      As a novel lymphatic tracer, carbon nanoparticles (CN) have been applied successfully in the     detection of sentinel lymph nodes in breast and gastric cancers, while not been used as a     lymphatic tracer for PTC. The goal of this study was to evaluate whether the use of CN     facilitates the detection of lymph nodes, increases the number of metastatic lymph nodes     removed, accurately reflects the metastatic condition of the central neck, and has the     potential to protect the parathyroid glands.   "
42897|NCT02724163|"     The main purpose of this study is :        1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses)          is tolerated and can be safety delivered in combination with cytarabine plus          mitoxantrone or liposomal daunorubicin in induction        2. To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin          (anthracycline) & cytarabine as induction therapy.        3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of          doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with          induction chemotherapy.        4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine &          cytarabine (FLA) in standard risk patients.        5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant          (HSCT) conditioning regimens of different intensity: conventional myeloablative          conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning          (RIC) with fludarabine/busulfan.   "
42898|NCT02724150|"     Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in     the management of acute peptic ulcer bleeding   "
42899|NCT02724137|"     The purpose of this study is to:        1. Determine whether the Physical Therapy (PT) & Fitbit® intervention should proceed to a          full-scale clinical trial. This decision will be based on three hypotheses: Treatment          promise (Hypothesis 1A): People in the PT & Fitbit® will walk 1250 more steps/day and          spend 7 min/day more in moderate to vigorous physical activity (MVPA) than the control          at discharge and at 6 months and 12 months, Safety (Hypothesis 1B): < 5% will have          adverse events because of the intervention, A research assistant will collect data on          adverse events that occur from the time of randomization until the last follow-up visit          3 months after discharge from PT. An adverse event is any unfavorable or unintended          diagnosis, sign, symptom, or disease temporarily associated with the study intervention,          which may or may not be related to the intervention. Adverse events include any new          events not present during the pre-intervention period or events that were present during          the pre-intervention period which have increased in severity. Major adverse events, such          as infection, re-hospitalization or development of new comorbidities will also be noted.          Recruitment (Hypothesis 1C): 75 recruited, 90% to complete trial, and 85% complete visit          at 6 months and 12 months.        2. To evaluate the short- and long-term adherence of the PT & Fitbit® intervention.          Short-term Adherence (Hypothesis 2A): 90% of subjects in the PT& Fitbit® group will wear          the Fitbit® and participate in goal setting and behavioral counseling while in PT.          Long-term Adherence (Hypothesis 2B): 75% of PT & Fitbit® will wear the Fitbit® at 6          months and 12 months.        3. To quantify changes in potential underlying mechanisms for increased physical activity.          (Hypothesis 3): Change in self-efficacy for physical activity, walking endurance and          participation in daily activities will be associated with improvements in physical          activity.        4. To assess intervention fidelity (Hypothesis 4): (4a) using the electronic medical          record, the treating PT will check off that they 1) reviewed physical activity recorded          by the Fitbit® and 2) discussed step goals for all study subjects randomized to the          intervention group. (4b) treating PTs will be asked to audio record five-intervention          interactions/week using a digital audio recorder. A research assistant will then assess          whether the PT 1) reviewed physical activity and 2) discussed step goals. Lastly, the          duration of the intervention will be noted.   "
42900|NCT02724124|"     The purpose of this study is analyze the effects of static stretching and active warm up,     isolated and associated, in functional performance of the lower limbs in college volleyball     athletes.      Study hypothesis:      H0: The stretching and / or warm up, alone or in combination, do not alter the functional     performance of volleyball players.      H1: The stretching and / or warm up, alone or in combination, alter the functional     performance of volleyball players.   "
42904|NCT02724072|"     The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™     Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending     thoracic aorta, with or without involvement of ascending aorta.      The study will also assess safety and early clinical outcomes in patients who receive an     extension procedure within 1 year of Thoraflex™ Hybrid Device implantation.      Lastly the study will assess the safety and clinical outcomes of patients who receive a     Thoraflex™ Hybrid Device for treatment of a ruptured aorta.      Patients will be followed for 3 years.      The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1     year post-procedure.   "
42905|NCT02724059|"     The study will include 30 patients with hilar/mediastinal lymph nodes detected by thoracic CT     either there was a known lung malignancy (for staging purpose) or not (for diagnosing     purpose).      All patients will undergo to EBUS-guided TBNA. Elastography will be performed on all lymph     nodes that will be candidates for EBUS TBNA. Mediastinoscopy or other invasive procedures     will be performed if EBUS-guided TBNA doesn't provide representative material.   "
42906|NCT02724046|"     This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the     contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic.     One third of enrolled villages will receive standard care; in one-third of villages,     household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin;     and in one-third of villages, the entire village will be offered a single dose of oral     ciprofloxacin after the notification of the first case in the village.   "
42907|NCT02724033|"     The investigators would like to compare the therapeutic and cost effectiveness of established     therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck     area an intervention known for analgesia but for which the antiemetic effects hasn't been     entirely explored.      The rational is based on the knowledge of the anatomical innervation of the inner ear and the     role of the parasympathetic nervous system in the emetic act. A lot of focus has been given     on its counterpart the sympathetic nervous system and its role in painful conditions. The     investigators believe that the nerve blockade of the parasympathetic innervation can have     some beneficial effect in the post-surgical patient.   "
42908|NCT02724020|"     This study will evaluate the efficacy and safety of single-agent MLN0128 and the combination     of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with     metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular     endothelial growth factor (VEGF)-targeted therapy.   "
42909|NCT02724007|"     The aim of this study is to validate international versions of the International     Classification of Disease Injury Severity Score (ICISS) in adult trauma patients admitted to     four public university hospitals in urban India.   "
42910|NCT02723994|"     This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent     chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the     study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy     regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the     recommended dose determined in Part 1.   "
42911|NCT02723981|"     Prospective, multi-centre, randomized, open-label, parallel comparisons to evaluate        -  the incidence of bleedings (COSTA-Bleed) and        -  the incidence of ischemic and bleeding events (COSTA-Outcome) following a therapy with          the abluminal sirolimus coated bio-engineered stent (COMBO stent) in association with          short-term single antiplatelet therapy as compared to a guidelines-based strategy in          patients with coronary artery disease with an indication for chronic oral anticoagulant          therapy.   "
42912|NCT02723968|"     Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose     prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring     relies on oral glucose tolerance test . However, this test is neither sensitive nor specific.      The aim of this study is to compare sensitivity and specificity of different methods for GM     monitoring in children and adolescents with CF.      Continuous GM system (CGMS) will be used as the reference method. Results will be compared to     those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT),     homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model     assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C).     Patients will be classified into three groups according to CGMS: normal glucose tolerance,     impaired glucose tolerance and diabetes mellitus.   "
42962|NCT02723318|"     The investigators have partnered with financial coaching organizations to establish what the     investigators have termed a Medical-Financial Partnership (MFP) that offers financial     coaching to improve financial and mental health. The investigators will evaluate the MFP's     impact on cognition using the Patient Reported Outcomes Measurement Information System     (PROMIS) Cognition Short form 8a.   "
48678|NCT02648464|"     This safety pilot study evaluates the effect of hydroxychloroquine on preventing recurrent     cardiovascular events among myocardial infarction patients. Half of the participants will     receive hydroxychloroquine, whereas the other half will receive placebo during six months.   "
42913|NCT02723955|"     GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody     intended for the treatment of cancers of different histology. This is a first-time-in-human     (FTIH), open-label. multicenter study designed to investigate the safety, pharmacology, and     preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the     aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and     in combination with pembrolizumab or other immune therapies. The study is comprised of two     primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as     dose escalation phase and Part 1B as dose expansion phase; Part 2: GSK3359609 combination     therapy with Part 2A dose escalation phase and Part 2B dose expansion phase. Each part and     phase of the study includes a screening period, a treatment period, and a follow-up period.     The primary objective of the study is to determine the safety, tolerability, maximum     tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.   "
42914|NCT02723942|"     The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell     immunotherapy for GPC3 positive hepatocellular carcinoma.   "
42916|NCT02723916|"     High quality and effective parenting in the preschool years is connected with long term     positive child behavior and mental health outcomes. The purpose of the study, Parent     Training in Pediatric Primary Care: A Self-directed Tablet-based Approach, is to test the     outcomes and implementation of a tablet-based parent training program in Pediatric Primary     Care. Testing and evaluating the implementation of digitally delivered programs is important     to increase the ease, reach, sustainability, and integration of mental health prevention into     primary care settings.   "
42917|NCT02723903|"     A comparative study is conducted on the patients with suspected coronary artery disease     (CAD). The patient will undergo coronary angiography after a somatic symptom scale (SSS)     survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized     Anxiety Disorder 7-items (GAD-7). Patient is then treated according to the checklist score     and coronary angiography result. The efficacy, sensitivity and specificity of the SSS     checklist will be evaluated during following up.   "
42918|NCT02723890|"     To investigate the efficacy and safety of using the novel Tyto device for remote physical     examination by co-investigators as compared to a standard medical physical examination by     physicians.   "
42919|NCT02723877|"     This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation     followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics     of PQR309 in combination with standard dose of eribulin in patients with locally advanced or     metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion     part).   "
42920|NCT02723864|"     Background:      The drug cisplatin treats certain cancers when given with other chemotherapy drugs.     Researchers think combining cisplatin with 2 other drugs could block proteins that support     cancer cell growth. The other drugs are ABT-888 (veliparib) and VX-970. They want to test if     this drug combination slows the growth of cancer and is safe.      Objectives:      To test the safety and tolerability of VX-970 and veliparib combined with cisplatin in people     with advanced refractory solid tumors. To determine the maximum tolerated dose of these     drugs.      Eligibility:      People ages 18 and older with:        -  Solid tumors that have progressed after treatment or for which no treatment exists        -  Normal organ and marrow function      Design:      Participants will be screened with:        -  Medical history        -  Physical exam        -  CT scan or MRI        -  Blood and urine tests      Participants will get the study drugs in 3-week cycles:        -  Cisplatin in a vein on 1 or 2 days        -  VX-970 in a vein on 2 days        -  Veliparib by mouth twice a day on 6 days      In each cycle, participants will have 5 physical exams and blood tests 5 times.      In some cycles, participants will have CT scans or MRIs.      In cycle 1, participants may have 2 tumor biopsies. A small piece of tissue is removed by     needle.      Participants will keep a study diary. They will write when they take the drugs and if they     have side effects.      Participants will stay in the study as long as they tolerate the drugs and their tumors are     not getting worse.      Participants will have a phone call about a month after their last dose.   "
42921|NCT02723851|"     Acute Myocardial Infarction (MI) is still the leading cause of death in the western world.     Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In     average it takes between 2-3 hours from the beginning of the chest pain. The damage to the     heart in these 2 hours is critical and often irreversible. Thus an early warning test or     device is highly warranted.      Corsens has developed a noninvasive device using several sensors applied to the chest and a     detection system able to recognize the ischemic origin of chest pain. This clinical study is     intended for evaluating the safety and efficacy of the Corsens technology while use for     myocardial infarction detection   "
42922|NCT02723838|"     The purpose of this study is to investigate the safety and efficacy of intratumoral REOLYSIN®     therapy alone and in combination with standard neoadjuvant gemcitabine and cisplatin in     muscle-invasive bladder cancer.   "
42933|NCT02723695|"     The cochlear implant is an electrical hearing aid that restores the perception of surrounding     sounds and speech intelligibility in profoundly deaf patients. During surgery, the     labyrinthine break necessary for insertion into the cochlea of the implantable part may cause     a malfunction of the vestibular system which can induce dizziness, balance and perception (of     the gravitational vertical) disorders. Vestibular compensation and new sonic interactions     could alter the balance control and the visual and postural spatial orientation perceptions.      The usual treatment includes the monitoring of the patient's quality of life, of the     vestibular function and of hearing. This study adds an assessment of spatial orientation and     of posture.   "
42934|NCT02723682|"     A 24-hour urine pilot study was conducted as part of the 2013 NHANES to test the feasibility     of implementing a 24-hour urine collection as part of NHANES in 2014.   "
42923|NCT02723825|"     Background: Epiphysis of distal end of tibia fracture is quite common in children epiphysis     injury, because of the complex damage mechanism and often leads to growth retardation and     joint deformity, the patient's physical and mental damage larger; also epiphysis injury     restoration requires higher standard and more difficult to fixed, and methods are being     actively explored to improve the curative effect and prevent the sequelae. Our hospital     pediatric department of orthopedics expects to conduct prospective study through multi center     to study the influence of factors such as the tibia epiphysis fracture of distal injury's     mechanism and initial and residual displacement and treatment etc. on patients' prognosis of     late growth disorders, joint deformity and ankle function.      Methods and analysis: To join the multi center research collaboration group of the south     pediatric department of orthopedics (including Pediatric Department of orthopedics of Wuhan     Union Hospital, Wuhan Tongji Hospital, Hunan Children's Hospital, Wuhan women and children's     Hospital, Foshan Hospital of traditional Chinese medicine, Shenzhen children's Hospital,     Guangzhou city women and children's Medical Center), the formation of multi center research     network, writing program, including the inclusion and exclusion criteria, grouping and     follow-up time, method. Participating in the working group meeting, listening to the expert's     opinions to improve research programs, formulate the tracking table of distal tibial     epiphyseal fracture, and starting to implement after approved by the medical ethics committee     of each hospital. The hospital is responsible for supervision in the whole process of project     implementation, and building the real-time reporting system, and it is the responsible person     of pediatric department of orthopedics of Foshan Hospital of TCM to do the random inspection.     After the completion of data collection, data entry and statistical analysis conducted by the     pediatric department of orthopedics in Foshan Hospital of TCM.      Ethics and promotion: The research is approved by the hospital medical ethics committee of     the south pediatric orthopedics multi center cooperative research group. Single blind method     is performed for children in the course of the study. Research data is shared by all     participating units and joints promotion of research results.      Registration: To register and update the study on the United States NIH ClinicalTrials.gov     website.   "
42924|NCT02723812|"     An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal     influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3     years old   "
43000|NCT02722824|"     Investigation efficacy of a non-invasive wearable electrostimulator device where the     supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally     and extracranially.   "
42926|NCT02723786|"     This is a phase 2 study to evaluate the efficacy, safety, tolerability and pharmacokinetics     of GSK1070806 in subjects undergoing renal transplantation. GSK1070806 is an anti-interleukin     18 (IL18) monoclonal antibody, which binds to IL-18 and inhibits signaling through the IL-18     receptor. Recipients of donor kidneys, retrieved after circulatory death of the donor, will     be administered a single intravenous infusion of GSK1070806 to test whether inhibition of     IL-18 can reduce the rate of Delayed Graft Function (DGF) and graft rejection. Subjects will     be followed for 12 months post dose/transplant. Up to 40 adult subjects will be enrolled in     this study.   "
42927|NCT02723773|"     The purpose of this study is a long-term follow-up of the two studies 110390 and 113077     (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK     Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2     additional doses in two subgroups of older adults.   "
42928|NCT02723760|"     This is an open-label SPECT/CT (single photon emission computed tomography/computed     tomography) study to investigate the diagnosis and efficacy evaluation performance of     99mTc-3PRGD2 in rheumatoid arthritis patients. A single dose of nearly 11.1 MBq/kg body     weight of 99mTc-3PRGD2 (≤20µg 3PRGD2) will be intravenously injected into the patients.     Visual and semiquantitative method will be used to assess the whole-body planar and lesions     section SPECT/CT images. Adverse events will also be observed in the patients.   "
42929|NCT02723747|"     The purpose of this study is to validate a full-automated post-processing software for     quantitative perfusion of the myocardium with magnetic resonance imaging.   "
42930|NCT02723734|"     The primary purpose of this study is to determine whether a tumor test recently developed by     GenomeDx Biosciences known as Decipher® can predict aggressive prostate cancer with the same     accuracy in African-American men (AAM) as in non-African-American men (NAAM). The Decipher®     test was developed from samples derived mainly from men of European origins and little is     known about its performance in AAM. It is important to study whether this test can be used in     AAM who are known to experience the highest rates of prostate cancer as well as death from     prostate cancer. The use of the Decipher® test result to predict how well a patient will do     before treatment may make it possible for doctors to distinguish aggressive disease from low     risk prostate cancer and modify treatment accordingly. Thus, patients that do not need     additional therapies may be spared from unnecessary side effects and those that are at risk     may be provided with more aggressive therapy to improve survival. This study is being done to     learn whether the Decipher test can really affect these outcomes.   "
42931|NCT02723721|"     Non-invasive lentigo maligna (LM) is characterized by an in situ proliferation of melanoma     cells, limited to the epidermis. It is found most commonly on the head and neck of elderly     persons, with a peak incidence in the seventh or eighth decade. If untreated, it may develop     into invasive melanoma. The gold standard treatment for LM is surgery using a 5-10 mm margin.     However, the lesions can be large, and conventional surgery can be difficult, particularly on     the face.      Then, there is a need for a topical non-surgical treatment of LM. Ingenol mebutate     (IM)/Picato® is able to induce cell apoptosis and an inflammatory reaction in the epidermis     and superficial dermis.      Thus, the investigators hypothesize that the topical use of Picato® could induce the cure or     a prolonged remission of non-invasive LM.      Because of the exploratory phase of this study (no case report and no clinical trial at the     early phase of designing this study, only one case report at the time of submission of this     form) the investigators will conduct an open label study limited to patients who are not     eligible to, or who refuse surgical treatment of their LM.      The main objective of this study is to determine the proportion of patients with complete     response (CR) obtained 2 months after one or two cycles (for patients who did not respond to     the first cycle) of topical treatment by IM 150 µg/g for non-invasive LM of the face (head     and neck).   "
42932|NCT02723708|"     The purpose of this study is to see if a non-medication intervention can increase motivation     in individuals with ADHD by observing brain activity using magnetic resonance imaging (MRI).   "
42935|NCT02723669|"     This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets     (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label,     Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.   "
43076|NCT02721836|"     The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit     of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to     nutrition counselling. Further, the potential of both interventions to influence the gut     microbiome will be inquired.   "
42936|NCT02723656|"     This is a population-based randomized controlled trial of 600 patients with a diagnosis of     cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that     will inform critical questions regarding the relative efficacy of care coordination options,     the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will     react to proactive tobacco related communications. Investigators will compare the reach and     efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm     1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm     randomized design at two urban cancer centers, and will explore cancer survivor attitudes and     preferences about proactive tobacco treatment.   "
42937|NCT02723643|"     The incidence and prevalence of hypertension is increasing while the controlled rate is     extremely low in China. A substantial percentage of participants with uncontrolled     hypertension are correctable if potential associated factors are identified and corrected.     Therefore, it is clinically relevant to investigate and identify these potential associated     factors of uncontrolled hypertension so as to increase controlled rate and reduce     hypertension-associated health and economic burdens in the future. Investigators plan to     conduct a prospective registry study in a single-center to initially investigate the     potential associated factors of uncontrolled hypertension in cardiovascular outpatient     department. Furthermore, investigators plan to evaluate the effects of potential associated     factors correction on hypertension controlled rate and cardiovascular outcomes.   "
42938|NCT02723630|"     This will be a randomized, single dose, open-label, three-treatment period crossover study in     healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the     level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.   "
42941|NCT02723591|"     This study will compare the incidence of a two-part composite endpoint consisting of de novo     donor specific antibody formation or a designation of immune activation  on peripheral     blood molecular profiling in patients maintained on twice daily, immediate-release tacrolimus     versus those maintained on Astagraf XL in the first two years post-transplant.   "
42942|NCT02723578|"     Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase,     dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the     folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural     mesothelioma and non-squamous non-small cell lung cancer. Preclinical and clinical studies     showed that pemetrexed had cytotoxic activity in many kinds of cancers including colorectal     cancer. Erlotinib is a tyrosine-kinase inhibitor of EGFR, which was approved for the     treatment of non-small cell lung cancer. Erlotinib also showed activity to colorectal cancer     cells. Recently, Zhang et al. demonstrated synergistic cytotoxicity of pemetrexed and     gefitinib in preclinical study.      In this multicenter, non randomized, open label phase II study, investigators aimed to     evaluate the efficacy and safety of Pemetrexed and Erlotinib combination.   "
42943|NCT02723565|"     This study will evaluate the heart, lungs and diaphragm of patients who fail a trial of     spontaneous breathing to determine the physiological mechanism of weaning failure.   "
42944|NCT02723552|"     TEPHRA investigates the effect of exercise on blood pressure and other cardiovascular factors     in young adults with different birth histories. TEPHRA will recruit 200 participants from     18-35 years old with elevated blood pressure (100 participants pre-term born and 100     full-term born). Half of the participants from each birth group will be randomised into a 16     week supervised aerobic exercise intervention trial and the other half will be controls.      Participants will complete 3 main study visits:        -  Visit 1: Baseline visit conducted at beginning of study        -  Visit 2: 16 weeks into study (upon completion of structured exercise intervention for          the exercise group)        -  Visit 3: End of study (52 weeks) Each visit will repeat the same set of cardiovascular          measures including CPET, echo, blood pressure, vascular stiffness, and other measures.           50 participants from each group will complete an MRI sub-study of the heart, brain, and          liver.   "
42945|NCT02723539|"     This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with     moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In     Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1     (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to     Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to     receive either topical application of MBN-101 or topical application of vehicle, applied     directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum     of 21 days. All patients will also receive systemic antibiotic treatment.   "
42946|NCT02723526|"     As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a     liquid biopsy, these circulating tumor cells (CTC) can show how a patient's cancer evolves     and responds to treatments. The purpose of this study is to determine whether sequentially     analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed     metastatic hormone-sensitive prostate cancer patients can predict the outcome of these     patients.   "
42947|NCT02723513|"     The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance     imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years     born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term     to characterize and probe the relationship between lung structure and function using imaging.   "
42948|NCT02723500|"     Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and     Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion     Coefficient (ADC) and ventilation defect volume obtained by analysis of hyperpolarized 129-Xe     MRI.   "
42952|NCT02723448|"     The goal of the investigator is to utilize Aclarubicin to treat patients with Retinal     Vasculopathy with Cerebral Leukodystrophy (RVCL), a rare and devastating genetic disease with     no available specific treatment. RVCL results from a mutation in the tail end of the TREX1     (Three Prime Repair Exonuclease 1) gene, a major deoxyribonucleic acid (DNA) repair enzyme.     The RVCL-specific mutations cause expression of a truncated and mislocalized protein. RVCL is     an inherited disorder whose symptoms begin at middle age and initially predominantly affects     the eye and brain. Because it is an 'autosomal dominant' disease, it strikes both males and     females equally. A person with RVCL has a 50-50 chance of transmitting the gene to each     child.      The investigator's published studies demonstrated in a mouse model for RVCL and in vitro     studies with patients' cells that defects were corrected by use of Aclarubicin, an     anthracycline antibiotic often used to treat cancer. Thus, there is a strong rationale for     conducting a clinical trial of aclarubicin in patients with RVCL.      The dosage to be initially administered to RVCL patients initially will be < 10% of that     typically used in cancer therapeutics and will be given monthly on four consecutive days for     six months. Patients will undergo assessments every six months to determine disease response.     Patients that do not have clear objective response may be dose escalated by 1 dose level with     permission of the principal investigator permitting the patient has not previously     experienced any toxicities requiring dose modifications. We will evaluate the safety and     clinical efficacy of Aclarubicin for the treatment of RVCL and evaluate its effects on     cellular function. This work will generate the first clinical research data on the     investigational product's utility in treating RVCL.   "
42953|NCT02723435|"     This phase II trial studies the side effects and how well midostaurin works in treating older     patients with acute myeloid leukemia with change in genetic material post-hematopoietic cell     transplantation. Midostaruin may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving midostaruin post-transplant may improve patient     outcomes.   "
42954|NCT02723422|"     The primary purpose of this this randomized interventional study is to determine if increased     level of home-based rehabilitation coupled with a pre-TAVR consultation visit in     transcatheter aortic valve replacement patients will improve functional status and quality of     life and will decrease hospital readmission.   "
42956|NCT02723396|"     Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory     improvement in motor function reported by around 50% of patients affected by Parkinson's     Disease (PD) after sleep and before taking their first dose of dopaminergic medications. This     study aims at systematically characterizing SB in PD patients in an ecological setting and to     explore the relationships between nocturnal and diurnal sleep and subjective and objective     measures of motor function. A better understanding of this phenomenon is mandatory for future     research on this topic.   "
42957|NCT02723383|"     Background: Alcohol is the leading psychoactive substance consumed in France, with about 15     million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA)     considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for     women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its     incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness,     extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without     appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.      Methods/Design: This prospective, randomised, controlled study versus placebo will be     conducted in twelve French intensive care units (ICU). Patients with an alcohol intake higher     than the NIAAA threshold, under mechanical ventilation, will be included. The primary     objective is to determine whether Baclofen is more efficient than placebo in preventing     restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation     duration, length of ICU stay, cumulative doses of sedatives and painkillers received within     28 days of ICU admission. Restlessness-related side effects are defined as unplanned     extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device     removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be     guided by creatinine clearance assessment once a day.      Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA     is a randomised study assessing the capacity of Baclofen to prevent agitation in     mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is     expected to end in June 2018.   "
42958|NCT02723370|"     The purpose of this study is to compare the effect of physician education about evidence     based practices for colonoscopy alone, versus physician education plus a multi-component     staff implementation strategy to improve adequacy of bowel preparation. Additionally the     investigators will examine implementation factors that influence adoption of the evidence     based practices.   "
42959|NCT02723357|"     The investigators have partnered with financial coaching organizations to establish what the     investigators have termed a Medical-Financial Partnership (MFP) that offers financial     coaching to improve financial and mental health. The investigators will evaluate the MFP's     impact on mental health using the Kessler-6 emotional distress scale.   "
42960|NCT02723344|"     Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability     to and aggravation and perpetuation of adverse consequences among those with co-occurring     mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study begins the     process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic to     treat chronic symptoms associated with co-occurring mTBI and PTSD among Veterans. By looking     at the impact of probiotic supplementation on biological signatures of increased     inflammation, as reflected by the gut microbiota, gut permeability, and biomarkers of     peripheral inflammation, this study may lead to the identification of a novel intervention     for the treatment of symptoms associated with these frequently co-occurring conditions.   "
42961|NCT02723331|"     The objective of this study is to estimate the R0 resection rate in patients with Resectable     Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal     Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of     combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).   "
42963|NCT02723305|"     This study plans to learn more about how to measure the way the the body's energy system     works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This     is important to know so that investigators understand how hormones and an extra X chromosome     relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.   "
42964|NCT02723292|"     As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is     partnering with the City of Rochester Department of Recreation and Youth Services to evaluate     the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth     registered at 11 selected Recreation Centers (RCs). A youth development program with     demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has     never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will     also measure program fidelity obtained in RCs.   "
42965|NCT02723279|"     The purpose of this study is to compare the efficacy of electrical pudendal nerve stimulation     (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.   "
42966|NCT02723266|"     The purpose of this study is to modify an existing Reproductive Health intervention for     adolescents with diabetes for Gestational Diabetes and make it culturally appropriate     American Indian/Alaska Native adolescents. The intervention will then be evaluated for     effectiveness in AI/AN female teens at risk for GDM.   "
42967|NCT02723253|"     Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced     rectal cancer with a positive impact on locoregional control and survival.However, patients     with T4 rectal cancer show high risk of local recurrence after conventional treatment.     Therefore investigators designed a prospective Phase II study on patients with locally     advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of     pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with     concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.   "
42968|NCT02723240|"     A two-part, phase I open label, dose escalation and expansion study to assess safety,     pharmacokinetics and clinical activity of NUC-3373, a nucleotide analogue, in participants     with advanced solid tumours.   "
42969|NCT02723227|"     The investigators have partnered with financial coaching organizations to establish what the     investigators have termed a Medical-Financial Partnership (MFP) that offers financial     coaching to improve financial and mental health. The investigators will evaluate the MFP's     impact on family economic strain and parental stress.   "
42970|NCT02723214|"     The purpose of the present study is to compare the characteristics, i.e. efficacy, duration,     safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the     standard frame-based stereotactic technique.      Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis     could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible     lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the     probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for     open craniotomy.      Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless     fiducial-less method using an optical based navigation system and a mini frame apparatus -     trajectory guide.   "
42971|NCT02723201|"     The purpose of this study is to assess the relative bioavailability of solid oral     formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation     and to evaluate the food effect and potentially the dose proportionality of the optimal oral     solid formulation.   "
42972|NCT02723188|"     The aim of this study is to examine the effects of transcranial electrical stimulation on     processes associated with fear extinction in healthy humans.   "
42973|NCT02723175|"     Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and     combined CBT+ tDCS on clinical pain and functioning among a sample of patients with     fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS     technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this     trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a     chronic pain-management approach.   "
42974|NCT02723162|"     This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC)     on neural circuitry function and treating nicotine addiction. Healthy adult nicotine     dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four     PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO.     Following 1 week of medication, participants will be contingently reinforced for 3 days of     smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI)     techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task.     Participants will be followed over the next 3 weeks of treatment and clinical variables will     be assessed.   "
42975|NCT02723149|"     This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention     reduces cannabis use compared to a control condition containing no active components of AAT.     Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or     control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed     to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham     conditions. Substance use and cognitive assessment will identify changes in MJ use patterns     and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance     imaging marijuana cue reactivity task, we will determine differences in neural response in     reward regions before and after 3 weeks of either AAT or sham treatment.   "
42976|NCT02723136|"     This study addresses the effectiveness of a smartphone application to improve academic     performance among medical students. Participants will be randomised to receive an application     developed by a team of physicians and engineers, designed to review key concepts in internal     medicine and its subspecialties. The primary outcome will be the number of correct answers in     a multiple choice test 4 weeks after randomisation.   "
43073|NCT02721875|"     The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose     (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of     intravenous volasertib as monotherapy or in combination with azacitidine in patients with     myelodysplastic syndrome (MDS) after hypomethylating agents (HMA) treatment failure.   "
42977|NCT02723123|"     Non-invasive respiratory support is routinely provided to extremely preterm infants following     disconnection from mechanical ventilation, in the form of continuous positive airway pressure     (CPAP) or non-invasive positive pressure ventilation (NIPPV). However, these modes remain     sub-optimal due to lack of synchronization and upper airway defensive mechanisms that     potentially hinder their effectiveness. Non-invasive Neurally Adjusted Ventilatory Assist     (NIV-NAVA) is a novel mode that may overcome some of these problems but has not been     investigated in this population. Investigators hypothesize that there will be significant     differences in cardiorespiratory behavior in extremely preterm infants receiving CPAP, NIPPV     and NIV-NAVA during the immediate post-extubation period.   "
42978|NCT02723110|"     Recent genetic association studies have identified variants in the Peptidyl-Glycine     alpha-amidating mono-oxygenase (PAM) gene that increase the risk of diabetes likely through a     defect in beta-cell function. This has been followed up and supported by novel kinetic assays     and cellular studies. This investigation will recall heterozygous carriers of the risk allele     at rs78408340 and age, BMI and gender matched controls from the Oxford Biobank. The study     will compare the incretin effect, glucagon-like peptide-1(GLP-1), insulin, glucose levels and     PAM protein activity in individuals both with and without the risk variant. The aim of the     study is to gain mechanistic insight into the effect of the variant on human physiology and     diabetes pathogenesis.   "
42979|NCT02723097|"     The objective of this protocol is to test the feasibility and acceptability of the Relaxation     Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body     skills and interventions to decrease medical and mental health symptoms and build resilience,     in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical     effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower     respiratory symptoms (LRS) and improve psychosocial functioning.   "
42980|NCT02723084|"     The purpose of this study is to evaluate the efficacy and safety of 8 weeks of treatment with     the combination regimen ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12     weeks in Hepatitis C Virus Genotype 2 (GT2) infected participants.   "
42981|NCT02723071|"     This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy     of ocrelizumab in participants with progressive follicular NHL.   "
42982|NCT02723058|"     The purpose of this study is to pilot test an adapted collaborative care model for homeless     mothers with depression.   "
42983|NCT02723045|"     To determine if there is a difference in the quality of life in between patients who     undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty   "
42984|NCT02723032|"     By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses     which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen     therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor     is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses     using a closed-loop system.   "
42985|NCT02723019|"     Mi Puente (or My Bridge) is a culturally-tailored, interdisciplinary approach designed to     support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as     they navigate the multi-level barriers that contribute to inequities in health care access     and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi     Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership     between inpatient and outpatient care settings to meet the integrated (i.e., physical and     behavioral) health needs of Hispanics who are hospitalized with multiple chronic     cardiometabolic conditions and one or more behavioral health concern(s). Participants will be     tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the     US/Mexico border region of South San Diego County, CA. The proposed randomized controlled     trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge     procedures) in improving hospital utilization, patient-reported, and cost effectiveness     outcomes. Electronic medical records (EMR) will be used to identify eligible patients and     examine primary outcomes.   "
42986|NCT02723006|"     The purpose of this study is to determine the initial safety profile and initial antitumor     activity of the combination treatments (immune checkpoint inhibitors [nivolumab, ipilimumab]     with investigational drugs [TAK-580, TAK-202 (plozalizumab), vedolizumab]) in the 3 arms when     administered to participants with advanced melanoma.   "
42987|NCT02722993|"     To assess the effect of a probiotic product, when co-administered with antibiotics, on     gastrointestinal symptoms following antibiotic treatment in children.   "
42988|NCT02722980|"     The aim of the current study is to evaluate the efficacy of a probiotic product on bone     mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The     primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of     12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes     in bone turnover markers during the period of 12 months.   "
42989|NCT02722967|"     This study will assess the helpfulness of the integrated call center in optimizing use of the     Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or     Bipolar Disorder taking oral aripiprazole.   "
42990|NCT02722954|"     The purpose of this study is to test the efficacy and safety of an experimental drug,     demcizumab, when given in combination with pembrolizumab. Demcizumab is a humanized     monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the     growth of cancer stem cells, the remaining cancer cells, and it may also impair the     productive growth of new blood vessels, which tumors need to grow and spread.      This study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the     Sponsor in this consent form.   "
42991|NCT02722941|"     The purpose of this study is to learn more about ways to prevent or delay relapse of multiple     myeloma (MM). This study will determine the best dosing schedule of LBH589 maintenance     therapy as well as the safety (side effects) and tolerability of LBH589 maintenance therapy     after autologous hematopoietic cell transplant (HCT).   "
42992|NCT02722928|"     The aim of this study is to compare the incidence and volume of postoperative pneumocephalus     in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a     conventional 1:1 oxygen/air gas mixture.   "
42993|NCT02722915|"     The aim of the study is the examination of brain plasticity on verbal auditory hallucinations     (AVH) after neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback.     During the training of fMRI neurofeedback subjects are trained to regulate consciously the     connectivity of areas which are associated with hallucinations.The aim is to improve     perceived hallucinations' intensity in everyday life of the patients as well as investigating     the impact of neurofeedback on resting-state networks in the brain. As control groups,     control subjects without AVH and participants with AVH, but no psychiatric diagnosis will be     included.   "
42994|NCT02722902|"     Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased     metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state     to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is an     early hallmark in the development of diabetes. Recent evidence suggests that a low carnitine     availability may limit acetylcarnitine formation, thereby reducing metabolic flexibility.     Thus, when substrate flux in the muscle is high, acetyl-CoA concentrations increase, leading     to inhibition of pyruvate dehydrogenase (PDH) and thereby reducing glucose oxidation. The     conversion of acetyl-CoA to acetylcarnitine relieves this acetyl-CoA pressure on PDH. To     provide more direct insight into the effect of carnitine in preventing metabolic     inflexibility and insulin resistance and to further explore the mechanism of action is the     focus of this research. Here, we hypothesize that the capacity to form acetylcarnitine may     rescue lipid-induced insulin resistance. To this end, insulin resistance will be induced by     lipid infusion in healthy volunteers and it will be tested whether carnitine co-infusion can     alleviate insulin resistance.   "
42995|NCT02722889|"     Aim of this study is to measure length of the ascending aorta in adults and to investigate     the clinical implication of 'elongation' of the aorta.   "
42996|NCT02722876|"     The purpose of this study is to evaluate the efficacy of a cross-education rehabilitation     intervention following anterior cruciate ligament reconstruction on ameliorating the acute     losses to function and performance. The cross-education phenomenon describes the strength     gain in the opposite, untrained (surgical) limb following unilateral resistance training of     the 'trained' (non-surgical) limb.   "
42997|NCT02722863|"     This Post-Marketing Surveillance will be conducted in accordance with the local regulation of     New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination     period (01Sep2011~31Aug2017). Each subject will be observed at least for 4 days during the     surveillance period.   "
42998|NCT02722850|"     In this parallel group study, participants were randomized to either 1 of 3 conditions (a)     fruit and vegetable consumption, (b) dietary fat and added sugars, or (c) physical activity.   "
43001|NCT02722811|"     Primary aim: evaluate efficacy of subcutaneous injection of etanercept for moderate and     severe knee osteoarthritis.      Second aim: investigate the potentiality of serum cytokines (TNF-α, Interleukin 1-α (IL1-α),     IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of subcutaneous     injection of etanercept for moderate and severe knee osteoarthritis.   "
43002|NCT02722798|"     The purpose of the study is to evaluate the efficacy and safety of KRN23 after its 48-week     once every 4 weeks repeated subcutaneous administration to Japanese and Korean patients with     Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome by a multicenter, open-label,     intraindividual dose adjustment study   "
43003|NCT02722785|"     Background:      For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the     perioperative course of therapy is associated with severe deconditioning which includes     weight loss and poor physical function, which are strong predictor of post-surgical     complication and survival . A strong rationale exists to explore how to develop supportive     interventions aimed at maintaining/improving muscle function (lean body mass and muscle     strength) during the pre-surgical phase.      This study explores the safety, feasibility and efficacy of structured pre- and     post-operative exercise training in patient undergoing surgery for cancer of the     gastro-esophageal junction.      Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ     scheduled for treatment af Rigshospitalet, Copenhagen, Denmark.      Methods: In a case-control design, patients will be allocated to either an exercise training     intervention group, or a usual-care observational group, based on geographical location.     Forty patients will be included in this case-control study and allocated by geographical     region as follows; 20 training intervention-cases living in the greater Copenhagen area, and     20 observational control subjects living outside the greater Copenhagen area.      All patients will undergo a total of 5 assessments during the perioperative trajectory; twice     prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and 15     weeks post-surgery, and at 1-year follow-up).      Assessments include measures of body composition by DXA scan and bioelectrical impedance     analysis: systemic inflammation in fasting blood sample; quality of life by self-report     questionnaires; physical function by handgrip strength and sit-to-stand test.      As optional procedures, we will collect biological tissue from tumor, muscle and fat biopsies     and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will collect blood     samples before, during and after an acute exercise bout exercise in order to explore the     acute systemic changes in exercise-regulated biomarkers.   "
43004|NCT02722772|"     Primary aim: evaluate efficacy of intra-articular injection of etanercept for moderate and     severe knee osteoarthritis.      Second aim: investigate the potentiality of serum cytokines (TNF-α, Interleukin 1-α (IL1-α),     IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of intra-articular     injection of etanercept for moderate and severe knee osteoarthritis.   "
43005|NCT02722759|"     In this prospective study different methods of haemoglobin measurement in term and preterm     neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the     Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@,     Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin     measurement by an automated hematology analyzer (labHb, Siemens Advia®).   "
43074|NCT02721862|"     This is a randomized double-blind placebo-controlled trial with a total of 100 patients who     are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic     Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of     three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for     gallstones.   "
43006|NCT02722746|"     Epidural analgesia via continuous epidurally infused local anesthetic agent (LA) is widely     and very successfully used routinely for perioperative pain control in patients undergoing     major orthopedic and abdominal surgery since 1928. The choice currently depends on the     preference of the APS physician in charge of the case. A frequent unwanted side effect of     epidural block is hypotension due to the epidurally injected LA blocking the sympathetic     nerves and thus the patient's response to hypotension, which is usually due to hypovolemia     and/or an unopposed parasympathetic (via the vagus nerve) nervous system. The purpose of this     research study is to see if adding epinephrine, to the epidural anesthetic will decrease     possible side effects, such as low blood pressure, and lead to a better effect of the     epidural anesthetic.   "
43007|NCT02722733|"     The purpose of the study is to compare safety and efficacy of stem cell mobilization using     G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's     lymphoma and non-Hodgkin's lymphoma patients.   "
43008|NCT02722720|"     The aim is to compare the safety of using transfemoral and transradial approach in patient     undergoing carotid arteries stenting.   "
43009|NCT02722707|"     This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for fecal     incontinence. This device is indicated for the treatment of fecal incontinence in patients     who are not candidates for or have previously failed conservative treatment and less invasive     therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).   "
43010|NCT02722694|"     The primary objective of this study is to demonstrate superior efficacy of abatacept 125mg     administrated SC weekly comparing to placebo after 24 weeks treatment in Chinese subjects who     have active rheumatoid arthritis, are receiving methotrexate and experiencing an inadequate     response to methotrexate. This will be estimated by the proportion of subjects meeting the     American College of Rheumatology (ACR) criteria for 20% improvement (ACR20).   "
43011|NCT02722681|"     'Spinal lipoma' is a condition, present from before birth, in which fatty tissue (lipoma) is     attached to the lower end of the spinal cord, tethering it within the vertebral canal. The     cord normally moves up and down with respiration, whereas tethering prevents this movement,     and can lead to progressive neurological deterioration. The cord and spinal nerves become     stretched and their blood supply is damaged irreversibly. Disability may include weakness or     pain in the lower body, and urinary disorders in young children. Treatment is surgical, to     remove the lipoma and mobilise the spinal cord, with 60 such operations performed per year at     Great Ormond Street Hospital. This project aims to develop lipidomic biomarkers in order to     predict which children with spinal lipoma are at highest risk of neurological deterioration,     and require early surgery, while providing evidence to adopt a more conservative approach for     those at lower risk.   "
43012|NCT02722668|"     This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body     irradiation (TBI) preparative regimen with modifications based on factors including     diagnosis, disease status, and prior treatment. Single or double unit selected according to     current University of Minnesota umbilical cord blood graft selection algorithm.   "
43013|NCT02722655|"     The aim of this study is the identification of complications in diabetes mellitus pediatric     patients and to compare the clinical, anthropometric, and biochemical characteristics between     children in the different types of diabetes mellitus.   "
43014|NCT02722642|"     Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid     secretions. Inflammation results in progressive destruction of the normal lung architecture,     in particular the elastic fibers of bronchi. Currently there is no effective drug for     bronchiectasis. This study intends to carry out an open, single-center, non-randomized, self     control phase I/II clinical trial. During the treatment, bronchial basal cells (BCCs) will be     isolated from patients' own bronchi by bronchoscopic brushing and expanded in vitro. Cultured     cells will be injected directly into the lesion by fiberoptic bronchoscopy after lavage.     After six-month observation, the investigators will evaluate the safety and effectiveness of     the treatment by measuring the key indicator-- the CT imaging of dilated bronchi as well as     four secondary indicators including the pulmonary function, laboratory factor level,     incidence of acute exacerbation and the patients' self-evaluation.   "
43015|NCT02722629|"     The aim of the study is to estimate the prevalence of respiratory aspiration in patients with     COPD, in a tertiary hospital of Buenos Aires.   "
43016|NCT02722616|"     This research study is being done to collect data and analyze the motion of soft tissue in     the abdomen (liver, pancreas, stomach and intestines) of people who have pancreatic and liver     cancer as well as healthy volunteers.      During the study researchers will look at the movement of organs in the abdomen that     naturally occurs with breathing and with a bowel movement.      This study will examine the differences between abdominal soft tissue motion in healthy     volunteers and in cancer patients with the goal of developing a better way to manage and     minimize the abdominal soft tissue motion. Accurate location of the tumor is very important     in treatment delivery and reduction of toxicity.   "
43018|NCT02722590|"     The objective of this post-marketing surveillance study is to observe the safety profile of     Fycompa film-coated tablets 2/4/6/8/10/12 milligrams (mg) in a normal clinical practice     setting.   "
43019|NCT02722577|"     Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the     successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).   "
43075|NCT02721849|"     A randomized controlled trial to investigate the efficacy of yoga on tension type headache     and / or migraine in adolescents between 12 and 16 years, consisting of a four group design     which includes an 12 week yoga course and a three-month follow-up period. Both adolescent and     one parent will be randomized either to yoga or no treatment. Primary outcome will be pain     frequency in adolescents considering pain catastrophizing of parents.   "
43020|NCT02722564|"     This will be a prospective survey study. The participants will all be volunteers of legal     drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then     will be asked to verbally estimate their current blood alcohol concentration and if the     subject feels they are able to drive. At that time, their BAC level will be measured     objectively using a breath alcohol test (BAT) device. The participant will not be told their     objective value. This will continue with a verbal estimate and actual BAT reading after every     drink until the participant reaches a minimum BAC of 0.10. At this time, participants will     continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As     their blood alcohol level decreases, the investigators will ask the participant to estimate     their level every hour along with an actual reading until reaching 0.08. Statistical analyses     will be used to determine how accurate self estimation is in regards to blood alcohol     content.   "
43021|NCT02722551|"     Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter     Mitral Valve   "
43022|NCT02722538|"     The purpose of this study is to determine if TAR-200, an investigational drug-delivery     system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between     diagnosis and radical cystectomy (RC).   "
43023|NCT02722525|"     Learning about the impact of anti-androgen treatment has on cardiac function in patients with     prostate cancer may help plan treatment and help patients live more comfortably. This pilot     clinical trial will utilize cardiac magnetic resonance imaging (MRI) before a patient starts     hormone therapy and after 4 to 7 months of hormone therapy. The objective is to measure the     impact of hormone therapy (anti-androgen treatment) on cardiac function in patients with     prostate cancer.   "
43024|NCT02722512|"     The purpose of this study is to determine whether Heat Shock Protein Peptide Complex-96     (HSPPC-96) Vaccine is an feasible and safe treatment for pediatric patients with     newly-diagnosed High-Grade Gliomas or recurrent, resectable High-Grade Gliomas and     Ependymomas.   "
43025|NCT02722499|"     The aim of this study is to test the efficacy of financial incentives augmented     telephone-delivered diabetes education and skills training intervention in improving HbA1c     levels in African Americans (AA) with type 2 diabetes (T2DM).   "
43026|NCT02722486|"     The investigators aim to compare rehabilitation progress between control patients who will     undergo routine vestibular rehabilitation exercises and experimental patients who will     undergo exercises using a vibrotactile balance belt (Sensory Kinetics Balance Rehabilitation     System) in addition to their routine vestibular rehabilitation regimen during recovery from     diseases affecting the vestibular system. The results of this pilot study will help to     determine if the vibrotactile balance belt is a useful supplement to traditional vestibular     rehabilitation techniques in children suffering from vestibular impairment.   "
43038|NCT02722330|"     The aim of this clinical investigation is to evaluate objective and subjective hearing     performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System,     compared to the unaided hearing performance. Comparison of audiological test results with the     same sound processor on a Baha Softband will also be performed. Short term safety parameters     will be collected.   "
43039|NCT02722317|"     It was realized a case study in a batterer intervention program, where 86 men accepted to     participate. It was used the Centers for Disease Control and Prevention - Follow up     questionnaire, adapted to be used in Brazil.   "
43040|NCT02722304|"     The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of     weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects     with A1PI deficiency and Chronic obstructive pulmonary disease (COPD).   "
43041|NCT02722291|"     This study is aimed at presbyopic patients that do not require magnifying glass at close     rage. The purpose of this study is to investigate the functional and physiological changes in     eye induced by pinhole glass.   "
43027|NCT02722473|"     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for     250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of     life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the     initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the     improvement of mortality and neurological outcome has been achieved over the last decade     thanks to the systematic implementation of a period of targeted temperature control between     32 and 34 ° C in patients who benefited from the realization of at least one electrical     external shock.      There are theoretical and clinical arguments to think that achieving the same way a period of     targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest     with a non- shockable rhythm on arrival can also benefit from this procedure. However other     arguments are against this hypothesis including an increase in the risk of infection ,     worsening of the patient's hemodynamic status with no benefit to him. To answer this     question, we conduce a randomized multicenter study testing the potential improvement of     neurological outcome through this procedure targeted temperature control between 32.5 and     33.5 ° C in these patients.      NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain     biomarker) of two temperature target for targeted temperature management (33°C or 37°C) after     cardiac arrest in non-shockable rhythm.   "
43028|NCT02722460|"     The aim of the study is to determine surrogate markers for prognostication of unfavorable     outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These     patients are comatose. Conscious patients are unsuitable for prognostication.   "
43029|NCT02722447|"     The treatment of isolated distal deep vein thrombosis remains one of the most debated issues     in the field of venous thromboembolism and only very few studies have directly addressed the     issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this     study is to assess the long-term risk of recurrent venous thrombotic events in patients with     a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a     standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.   "
43030|NCT02722434|"     This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous     electrical nerve stimulation (TENS) therapy work in treating patients with     chemotherapy-induced peripheral neuropathy (a nerve problem that causes pain, numbness,     tingling, swelling, or muscle weakness in different parts of the body). MC5-A scrambler     therapy is a type of treatment for nerve pain that uses electrodes placed on the skin, where     electricity is carried from the electrodes through the skin and blocks the pain. TENS is a     procedure in which mild electric currents are applied to some areas of the skin. It is not     yet known whether TENS therapy is more effective than MC5-A scrambler therapy in treating     chemotherapy-induced peripheral neuropathy.   "
43031|NCT02722421|"     The purpose of this study is to determine whether increasing the dose of the levonorgestrel     subdermal contraceptive implant will overcome a detrimental drug-drug interaction with     efavirenz based antiretroviral therapy.   "
43032|NCT02722408|"     The purpose of this study is to assess the efficacy, safety, and tolerability of multiple     doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.   "
43033|NCT02722395|"     This study is a research and development initiative established to explore the use of     magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer     patients planning procedures for stereotactic body radiation therapy (SBRT).   "
43034|NCT02722382|"     Objective: The investigators will change the health system to improve care patients receive     as they transition through earlier stages of kidney disease toward kidney failure. They will     study whether these changes lead to patients' improved health and well-being.      Methods: The investigators will conduct this study in Geisinger Health System kidney     specialty clinics. The study will implement 'Patient Centered Kidney Transitions Care' which     will (1) give doctors tools to help them recognize when patients should prepare for kidney     failure and help them support patients' early and informed treatment decisions; and (2) add a     'Kidney Transitions Specialist' to the health care team to help patients learn about kidney     disease, learn self-care skills, make informed decisions, get psychosocial support, and     coordinate their care. Four (4) clinics will be randomly assigned to provide Patient Centered     Kidney Transitions Care, and four (4) to provide their usual care. The investigators will     study differences in patients' outcomes among those treated in clinics providing Patient     Centered Kidney Transitions Care compared to those treated in clinics providing usual care.      Patient Outcomes: Patients have told us they want to have 'control' over their disease     transitions and to have the best quality of life possible. The investigators will measure     patients' empowerment, confidence with their self-care, their decisions to start self-care     treatments for kidney failure, and their hospitalizations. They will also measure whether     doctors record patients' treatment preferences in the medical record before patients develop     kidney failure.      Patient and Stakeholder Engagement: This study responds to reports from hundreds of patients     and caregivers who want better care. Patients and caregivers from around the US are part of     our investigative team, and they will participate in all aspects of our study. The     investigators are also engaging key stakeholders in the kidney community, including patients,     providers, payers, and regulators.      Anticipated Impact: If effective, Patient Centered Kidney Transitions Care will provide a     model of care can improve the lives of patients and families with kidney disease across the     US.   "
43035|NCT02722369|"     To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ)     is associated with an improved clinical outcome (progression free and overall survival)     compared with chemotherapy alone in patients with small cell lung cancer (SCLC)   "
43036|NCT02722356|"     The proposed study is a prospective, randomized, active control, open label study. One     hundred sixty subjects undergoing elective cesarean section will be randomly assigned to one     of two groups (n = 80 per group): the oxytocin protocol group or the standard practice group.     The oxytocin protocol group will receive oxytocin boluses along with a regulated infusion     according to a stepwise algorithm following delivery of the placenta. The standard practice     group will receive oxytocin via a free flowing (wide-open) infusion with a concentration of     30 IU per 500 mL of 0.9% normal saline following the delivery of the placenta. Primary     outcomes include uterine tone (adequate or inadequate) as assessed by the surgeon, amount of     time required to establish adequate uterine tone following the delivery of the infant, total     dose of oxytocin required to establish adequate uterine tone, and total calculated blood loss     based on pre-operative and post-operative hematocrit concentrations. Secondary outcomes     include total estimated blood loss as agreed upon by the surgeon and the anesthesia provider,     use of additional uterotonic drugs, mean arterial pressure, and incidence of oxytocin side     effects (nausea, chest tightness/pain, and ST-segment changes).   "
43037|NCT02722343|"     This single site study is designed to describe and measure the efficacy of oral versus     vaginal dosing of TFV-based products, specifically emtricitabine/tenofovir disoproxil     fumarate oral tablets (Truvada) vs tenofovir intravaginal rings (IVR).   "
43044|NCT02722252|"     The centre for Medically-Assisted Procreation (MAP) of Dijon CHU has two high-technology     embryo culture systems, with incubation characteristics that are potentially superior to     those provided by classical culture systems. Indeed, these two systems, available in only two     MAP centres in France, make it possible to maintain a stable temperature and gaseous     environment during the in-vitro development of the embryos.      It is necessary to observe the development of the embryos to determine which embryos have the     highest implantation potential. These observations are done from time to time by microscope     for one system and continuously using an incorporated video camera for the other     (cinematographic study). The MAP centre in Dijon wishes to compare the interest of these two     systems.   "
43045|NCT02722239|"     The aim of this study is to demonstrate bioequivalence of fixed dose combination     Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg,     (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol     Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2 x 500 mg)     (Merck Santé S.A.S., France) which are already registered in the Russian Federation.   "
43046|NCT02722226|"     Objective Sedation is a depression of consciousness varies between anxiolysis and general     anesthesia. It is used to facilitate diagnostic tests and minor surgeries. Respiratory     complication is the main side effect of the sedation. His Early diagnosis and adequate     management prevent serious complications such as hypoxic brain damage or death. A development     of a learning program of sedation is required. Simulation as a teaching tool has improved the     clinical expertise of learners. The objective of the study is to evaluate the impact of a     simulation based medical education program on the performance of non-resident     anesthesiologists for the management of complications related to sedation.      Methods This trial is randomized, controlled and single blinded. Non-resident     anesthesiologists, without prior training on sedation, are included and randomized to receive     or not a simulation based sedation learning. This program includes a pharmacology sedatives     learning, teaching technical skills for airway management on low fidelity mannequin and     high-fidelity simulation scenarios of these complications. Two evaluators, single-blinded,     visualise the recorded performance of residents in simulation session. The evaluation is     based on a performance checklist developed by Delphi technique. It compares the performance     of the residents within the same group before and after the simulation based medical     education program and to compare groups of residents.      Data analysis The sample size is based on similar simulation studies. The results are     compared with the variance analysis for repeated measures. The difference in performance     before and after simulation is compared using a t test.      The investigators hypotheses that improved performance scores following the simulation based     medical education would put the dot on the importance of simulation as a learning tool.   "
43047|NCT02722213|"     The guideline-recommended standard of care for patients who have experienced a heart attack,     heart failure, or other coronary event or procedure is exercise-based cardiac rehabilitation     (CR). Despite proven benefits, traditional CR is severely underutilized. Moreover, what is     typically lacking from traditional CR programs is effective psychosocial risk management.     This represents a critical gap in care given the well-documented psychosocial needs of this     patient population.The objective of this feasibility study is to conduct a pilot randomized     controlled trial (RCT) of Mindfulness-Based Stress Reduction (MBSR) versus usual care in     CR-eligible cardiac patients. Randomization will be stratified within two strata based on     participation in CR (yes/no) among CR-eligible patients. The primary goals of this pilot     study are to: 1) obtain estimates of treatment effects and variability; 2) evaluate     recruitment and retention strategies; and 3) examine the safety of the MBSR protocol in     CR-eligible patients.   "
43048|NCT02722200|"     The purpose of this study is to examine if glucocorticoids will change neural activation in     regions of the corticolimbic-striatal system that regulate feeding.   "
43049|NCT02722187|"     This study is to set the place of microsurgery in surgical treatment od varicocele in     infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while     the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.   "
43050|NCT02722174|"     The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders     clinically associated with impulsivity and in health controls, to: 1) investigate if the     different populations have a distinct behavioral profile, and 2) to investigate if there are     specific measures that are reliable and sensitive measures of impulsivity across diagnoses.   "
43051|NCT02722161|"     To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and     [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a     single oral dose of [14C]BI 1482694 given to healthy male volunteers   "
43052|NCT02722148|"     This is a prospective single center clinical trial of allergen-specific immune     signature-guided dietary elimination therapy to assess the clinical effectiveness of this     technique.   "
43053|NCT02722135|"     This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for     further development by evaluation of DLT in course 1 and the safety of volasertib when added     to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after     failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in     paediatric patients with AML when added to standard intensive salvage chemotherapy will be     collected.   "
43054|NCT02722122|"     This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy     Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.   "
43055|NCT02722109|"     Researchers want to compare proton stopping ratios, used for proton beam therapy planning,     calculated based on single energy CT and dual energy CT images; with the intension of improve     upon the proton range determination.   "
43056|NCT02722096|"     Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is     the best primary vascular access for hemodialysis in patients with end stage renal disease.     The primary complications are common, of the order of 10-36 %, including lack of maturation     and dominated by stenosis and thrombosis.      Local anesthesia associated with sedation is a validated method of anesthesia for made     arteriovenous fistula but does not cause the motor block and not blocking vasospasm,     deleterious to the surgery. Multiple injections necessary to cover the operating zone expose     patient to pain and to intravascular injection of local anesthetics.      Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic     block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It     enables an increased flow rate at an early time fistula and faster maturation.      However, studies included low numbers of patient or are non-randomized. They cannot concluded     a significant difference in the complication rate of arteriovenous fistula at an early time     depending on the type of anesthesia .      This study aims to demonstrate that axillary block for surgical creation of arteriovenous     fistula allows a reduction of complications at 6 weeks compared to local anesthesia   "
43057|NCT02722083|"     The purpose of the study is to explore the onset of effect of an antihistamine in a     controlled environment.   "
43058|NCT02722070|"     The main objective of the study is to explore and map brain areas involved in processing and     perception in patients suffering from neurological pathologies and condition. The     investigators hypothesize for example, that a change (compare to healthy subjects) in the     perceptual maps and body representation could be detected and characterize in patients     suffering from impairments of peripheral nerve conduction.   "
43059|NCT02722057|"     The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco®     (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe     the long-term safety and effectiveness of Kalydeco in CF patients with the R117H-CFTR     mutation overall and in patients ≥18 years. The long-term safety and effectiveness of     Kalydeco will be examined in totality through the evaluation of the primary outcome measures.   "
43060|NCT02722044|"     The purpose of this study is to evaluate the usability of an auto-injector (AI) for the     delivery of M923 in patients with rheumatoid arthritis (RA)   "
43072|NCT02721888|"     Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic     syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be     associated with lipid abnormalities (such as hypertriglyceridemia and decreased     HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities     (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type     2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated between     3 and 5%).      Animal studies have shown that liraglutide is able to decrease liver fat content, but the     effect of liraglutide on liver fat content in patients with diabetes remains unknown.      In addition, human studies with liraglutide have shown significant modification of plasma     lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the     mechanisms responsible for these liraglutide induced lipid modifications are not yet known.      Because increased in liver fat content and hypertriglyceridemia are associated in patients     with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver     fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver     fat content assessment and kinetic study with stable isotope to study lipoprotein     metabolism).      This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in     patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide     therapy (1.2 mg/day).      Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in 10     patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month period     of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a 2-day     hospitalization      For the main study, 3 visits will be performed:        -  a first visit at T0, before starting the treatment with liraglutide, including clinical          and biological measurements and liver fat content assessment by proton-spectroscopy        -  a visit at 3 months including clinical and biological measurements        -  and a visit at 6 months including clinical and biological measurements and liver fat          content assessment by proton-spectroscopy      For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will     been performs during a 48h-hospitalization before starting the treatment with liraglutide and     after 6 month-treatment with liraglutide   "
43061|NCT02722031|"     Hypoxemia is usually observed during ICU stay. Nevertheless, the prevalence of hypoxemia     among patients admitted in ICU is not well known, in partly due to a lack of a consensual     definition. Some of these patients meet the criteria of Acute Respiratory Distress Syndrome     whom the definition has been recently modified in 2011. Many uncertainties are remaining in     considering the patients with ARDS: prevalence of the category of mild ARDS, the proportion     of patients with invasive mechanical ventilation, the therapeutic modalities and the     prognosis, in particular, the move towards a more severe ARDS category. Finally, many     patients with hypoxemia do not meet ARDS definition. The prevalence of this population in ICU     is unknown, likewise its prognosis. In this way, it would be interesting to compare, for each     levels of hypoxemia (mild, moderate and severe) the prognosis of the patients with and     without ARDS.      The main objective of the SPECTRUM study is to assess the prevalence of hypoxemia in     French-speaking Intensive Care Unit in 2016 in using a single-day point-prevalence study     design. Two periods of inclusion have been, actually, planned: from the 29th Mars to the 31st     Mars and from the 5th to the 7th April. In each participating center, the day of the study     will be chosen among these periods.   "
43062|NCT02722018|"     This is a phase 1, randomized, open-label, single center, crossover study to investigate the     effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy     participants of non-childbearing potential. This study is divided into three parts.     Participants in each part will be randomized to one of three treatment sequences. Part 1     study in 4 periods will investigate the effect of formulation on the pharmacokinetics (PK) of     GDC-0810 administered with low-fat food. Each participant in this part will receive a single     dose of GDC-0810 dose level A following consumption of a low fat meal (30 minutes after the     start of the meal) in each treatment period. Part 2 is an optional Phase I study in 3 periods     to investigate the effect of formulation on the PK of GDC-0810 administered with low-fat food     in healthy female participants of non-childbearing potential. Part 3 study in three periods     will compare the PK of a Phase III prototype tablet formulation selected from Parts 1 and 2     of the study with the Phase II tablet formulation (both administered 30 minutes after the     start of a low fat meal) at dose level B and to investigate the PK of the Phase III prototype     formulation administered in the fasted state.   "
43063|NCT02722005|"     The investigators have partnered with financial coaching organizations to establish what the     investigators have termed a Medical-Financial Partnership (MFP) that offers financial     coaching to improve financial and mental health. The investigators will evaluate the MFP's     impact on health related quality of life using the Patient Reported Outcome Measurement     Information System (PROMIS) 10 Global Short Form.   "
43064|NCT02721992|"     The investigators have recently observed retrospectively that the occurrence of Graves'     Orbitopathy in patients with Graves' disease is less frequent in patients with normal     cholesterol levels, in line with another recent observation suggesting that statins play a     protective role in Graves' patients from developing Graves' Orbitopathy. The present study is     designed in order to investigate the possible association between Graves' Orbitopathy and     high cholesterol level as well as the relation between Graves' Orbitopathy degree and high     cholesterol level   "
43065|NCT02721979|"     This phase II trial studies how well ARN-509 (androgen receptor antagonist ARN-509) works in     treating patients with prostate cancer who are in active surveillance. Testosterone can cause     the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist     ARN-509 may fight prostate cancer by blocking the use of testosterone by the tumor cells.   "
43066|NCT02721966|"     The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or     300 mg in the management of axial manifestations in PsA patients who have failed to respond     to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according     to assessment of spondyloarthritis international society (ASAS) recommendations for the     treatment of axial spondyloarthritis (AxSpA).   "
43249|NCT02719574|"     This Phase 1/1b study will utilize a multicenter, open-label dose-escalation design to     evaluate the safety, PK, and PD of FT-2102 (single agent) and FT-2102 + azacitidine     (combination agent) administered via one or more intermittent dosing schedules. Approximately     48 patients will be enrolled in the dose-escalation portion of this study in one or more     schedules followed by approximately 14 patients in expansion cohorts   "
43067|NCT02721953|"     Butyrate is a short chain fatty acid (SCFA) produced by bacterial fermentation of undigested     starch in the gut. Butyrate carries out different effects at intestinal and extraintestinal     level, including: immune regulation with anti-inflammatory effect at intestinal and systemic     level and modulation of gut microbiota. Many of these effects result from an epigenetic     mechanism. Shown in an animal model of obesity induced by a high fat diet (HFD), that     butyrate can exercise very effective protective action against obesity through the     stimulation of intestinal satiety hormones. Shown always in murine model of obesity induced     by HFD, that butyrate is effective in preventing and treating obesity and insulin resistance.     After 5 weeks of treatment with butyrate was observed a reduction of 10.2% of body weight,     30% of fasting glucose and 50% insulin resistance.      In an animal model of metabolic syndrome with NAFLD researchers have recently demonstrated     that the administration of butyrate is able to significantly reduce insulin resistance, liver     damage, dyslipidaemia through a modulation of the inflammatory process.      Pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of     butyrate is safe and well tolerated. The peak serum levels occurs 4-6 hours after oral     administration.      All of these data makes plausible a possible positive effect on insulin resistance in the     obese child.   "
43068|NCT02721940|"     This study was mainly aimed to evaluate the efficacy of local administration of enriched bone     marrow mononuclear cells, platelets and zoledronic acid for the clinical prevention of     collapse of the early-stage osteonecrotic femoral head.   "
43069|NCT02721927|"     Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were     forced to leave their homes and sought refuge in neighboring countries.   "
43070|NCT02721914|"     The main goal of this study is to get to know if applying both, massotherapy plus     hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low     back pain. It actually reduces the inability produced by the pain and improve the patient's     quality of life as well as the join range of the lumbar spine, way more than these two     therapies applied separately.   "
43071|NCT02721901|"     The purpose of this study is to further develop the integrated Eating Aversion Treatment     (iEAT) manual, which is designed to address chronic food aversion in children with chronic     food refusal. This study will evaluate the feasibility and efficacy of the iEAT manual when     it is used in the home home environment with caregivers.   "
43077|NCT02721823|"     Patients with ulcerative colitis often suffer significant limitations to their quality of     life, which are also conditioned by particular stress and psychosocial accompanying symptoms     of the disease. A multimodal program for stress-reduction and lifestyle-modification has been     shown to be effective in promoting the quality of life. The study will examine the promotion     of the quality of life of patients with ulcerative colitis and the positive Influence on     stress, psychological symptoms and physiological parameters. 92 patients with ulcerative     colitis will be randomized in an Intervention group and a control group for 10 weeks. The     primary outcome is the disease-specific quality of life, the secondary outcomes are stress,     psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter     and the microbiome.   "
43078|NCT02721810|"     A no-cost intervention may improve adherence with a recommendation for higher-quality,     lower-cost care for patients with critical illness endorsed by a collaborative of critical     care societies. The investigators propose prompting consideration of functional outcomes.     This trial will help establish the impact of the intervention on practice patterns including     proxy engagement and elements of shared decision-making.   "
43079|NCT02721797|"     Ehlers-Danlos Syndrome (EDS) is an inherited disease of collagen, found in connective     tissues, such as skin. EDS patients suffer from joint and skin problems (skin     hyperextensibility, joint hypermobility) along with a large range of other disorders,     including, delayed wound healing with atrophic scarring, easy bruising, tissue fragility,     gastrointestinal and gum problems. There are many different types of EDS, with different     mechanisms of action, and not all of these are well understood. This study will used advanced     microscopy techniques called atomic force microscopy (AFM) and scanning electron microscopy     (SEM) to analyse the changes in collagen as a result of EDS, compared to normal collagen.     These changes will be viewed at the micron and nanoscale level (between 1,000 to 100,000 x     magnification), and will focus on the differences in collagen construction through a process     called cross-linking. These changes could potentially help clinicians understand the root     cause of EDS symptoms, and provide a deeper knowledge of cross-linking disorders in collagen.     Increasing our knowledge of how collagen is affected in EDS patients, may lead to improved     treatment options for patients.   "
43080|NCT02721784|"     The evaluation of the radiological changes in localised or locally advanced prostate cancer     after androgen deprivation therapy and external beam radiotherapy using multi-parametric MRI     (multi parametric magnetic resonance imaging) and VERDICT (Vascular, Extracellular and     Restricted Diffusion for Cytometry in Tumours) sequences.   "
43081|NCT02721771|"     Preeclampsia remains a leading cause of maternal morbidity and mortality, in both the     developed and developing world. It is a complex, multisystem disease which, in its severe     form, affects the cardiovascular, renal, hepatic, neurological and haematological systems.     The University of Cape Town-associated medical institutions alone were responsible for the     treatment of 800 women in 2014, who were classified as having preeclampsia with severe     features. Given the complexity of the disease, anesthetic management for Caesarean section in     these patients remains very challenging.      Recent studies have begun to demonstrate novel markers of preeclampsia severity, including     point-of-care ultrasound (POC-US) and acid-base (AB) abnormalities. For example, pilot     studies have demonstrated that approximately 25% of women diagnosed with severe preeclampsia     show signs of increased intracranial pressure and elevated lung water as evaluated by point     of care ultrasound. These findings could serve as noninvasive markers of disease severity,     and thus may be used to predict maternal and fetal outcome in preeclamptic women. Point of     care ultrasound is playing an increasing role in perioperative diagnosis, and newer, less     expensive devices are continuously being developed, and will in all likelihood play an     important role in South Africa in the near future.      In a recent trial performed at the University of Cape Town, a comprehensive acid-base     analysis in severe preeclamptic women demonstrated significant abnormalities in independent     acid-base determinants. In addition, strong indications were found that changes in acid-base     status in preeclampsia are more pronounced earlier in pregnancy and are associated with     urgent deliveries. As in other clinical arenas in critically ill patients, acid-base     abnormalities are associated with increased lung water, increased intracranial pressure, and     outcome, and we hypothesize that similar associations might be found in severe preeclamptic     women. Therefore, one aim of this study is to evaluate the association of venous acid base     abnormalities (an inexpensive and readily available test) observed in late onset severe     preeclampsia and organ manifestations identified with ultrasound, a well-validated and robust     tool for identifying these manifestations. Investigators will further examine the association     between ultrasound findings and/or venous acid-base abnormalities with urgent delivery. It is     intended to do a subsequent comparison between early- and late onset preeclampsia, when a     suitable tertiary site has been identified.   "
43083|NCT02721745|"     While the scientific community understands quite well why muscles ache after prolonged     exercise, the origins of mental fatigue remain totally mysterious. Existing theories remain     at a psychological level, with scarce supporting evidence. Mental fatigue typically occurs     after long episodes during which humans exert control on motor or cognitive processes,     instead of executing routine or stimulus-driven behaviours. However, work organization     (especially in risky job like airplane control or medical profession) and pathologies due to     an overload of work (like burn-out) seems to be directly linked to neural fatigue. One of the     consequences of neural fatigue is to alter decision-making. As an example, the choice between     an immediate monetary reward and a larger but delayed monetary reward (the so called     intertemporal choices) are susceptible to fatigue state of its underpinning neural network.      The investigators are proposing an exploratory study of neural fatigue, induced either in a     natural way (by performing cognitive tasks for hours) or by transcranial stimulation, using     three main physiological measures (Electro-encephalography to measure neural activity,     indirect calorimetry to measure the metabolic cost of a cognitive effort, and pupillometry to     measure cognitive effort).      This study should allow to better understand the consequences of neural fatigue on cognitive     functions like decision making as well as the associated physiological variables.   "
43084|NCT02721732|"     The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475)     can help control the disease in patients with advanced cancer.   "
43113|NCT02721355|"     H. pylori positive patient volunteers that passed the selection criteria are recruited and     divided into a test and a control group. Both groups are treated with a current treatment     regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day) but     only the test group received IgY-containing food supplement as an adjunctive measure for 15     days. The subjects are examined before and 4 weeks after the treatment initiation by Urea     Breath Test (UBT) and gastro-endoscopy.   "
43116|NCT02721316|"     To evaluate the impact of a specific nursing management (personalized and close, through     consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the     suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in     patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.   "
43085|NCT02721719|"     The cause of Inflammatory Bowl Disease (IBD) is not known, but studies from patients with IBD     have found that these patients make unusually strong immune responses to their own intestinal     tissues and to bacteria that normally live in the healthy gut. These overactive immune     responses might result from an imbalance of T-lymphocytes, which are a type of white blood     cell that recognize and respond to threats like infection or damaged tissues. In healthy     tissues, a type of T-lymphocytes called T-regulatory cells control excess inflammation by     preventing other T cells, called T-effector cells from responding. We believe that     T-regulatory cells are somehow less active in IBD, resulting in damage to intestinal tissues     by the T-effector cells.      T-lymphocytes, including both T-regulatory and T-effector cells, are guided to different     parts of the body by 'alpha4beta7-integrin' molecules. Vedolizumab or Entyvio works by     blocking this homing molecule so that T cells do not reach the intestine, but stay in the     blood where they cannot aggravate your IBD. This study will help in understanding how     Vedolizumab helps to heal or decrease the symptoms of your Ulcerative Colitis.      The effect of Vedolizumab on different types of T cells in the human intestine has not yet     been studied. However, the investigators think that Vedolizumab will shift the balance of T     cells in the intestine towards more healing T-regulatory cells and less damaging T-effector     cells. The purpose of this study is to measure the different types of T cells in     participants' blood and intestinal tissue before and during Vedolizumab treatment.   "
43086|NCT02721706|"     Objectives: To evaluate the cost-effectiveness of implementing a malnutrition screening tool     CIPA at the Hospital Universitario Nuestra Señora de la Candelaria (HUNSC), comparing the     impact on health and the healthcare costs of hospitalised patients who are screened for     malnutrition and of patients following standard clinical practice. Methodology: The study     will consist of a controlled trial on patients admitted to the Internal Medicine and General     and Digestive Surgery wards at the HUNSC. In both wards patients will be randomised to a     control or to an intervention group. The control group will follow usual hospital clinical     care, while the intervention group will be administered the screening tool CIPA for early     detection of malnutrition cases and they will be treated according to the screening results.     The following variables will be evaluated: length of stay in hospital, mortality,     readmissions and in-hospital complications. Cost-effectiveness analysis will be undertaken     measuring effectiveness by Quality-Adjusted Life Years (QALYs). Cost per patient will be     measured by identifying health care resource utilisation, and the cost-effectiveness measure     will be the Incremental Cost-Effectiveness Ratio (ICER). Investigators will calculate the     incremental cost per QALY gained related to the intervention. This analysis will allow to     quantify the costs (incurred and saved) related to the introduction of the malnutrition     screening tool CIPA in the hospital context and to measure the health impact of screened     patients.   "
43087|NCT02721693|"     The primary purpose of the study is to investigate if physical exercise is associated with     myocardial damage, expressed by elevated troponin T, in patients with COPD.   "
43101|NCT02721511|"     This is a, prospective, single center, open-label, pilot study to evaluate the safety and     efficacy of the subcutaneous administration of a novel furosemide formulation. The results of     this pilot study will be reviewed to determine the safety of the subcutaneous treatment     regimen and to evaluate patient selection criteria for possible at home treatment. The intent     is to conduct a future follow on study looking at the feasibility of at home treatment of     patients referred to a hospital for treatment of fluid overload.   "
43158|NCT02720757|"     The primary objective of this NIS is to measure changes in physical functioning, a surrogate     for physical activity and exercise capacity, in COPD patients on treatment with Spiolto®     Respimat® in routine daily treatment after approximately 6 weeks.      A secondary objective is to evaluate the patient's general condition (physician's evaluation)     from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of     the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto®     Respimat® at Visit 2.   "
43088|NCT02721680|"     The goal of the proposed project is to provide the Army with a brief, well-validated,     internet-based training program for enhancing Awareness Training and resilience skills. This     project will address the needs outlined for the Military Operational Medicine Research     Program, particularly with regard to enhancing Psychological Health and Resilience. The     fundamental approach of the project directly addresses the need to develop psychological     resilience among Service members and families to promote well-being and prevent behavioral     health outcomes. Addressing this need is crucial, as military personnel are often required     to serve under dangerous and emotionally stressful conditions. Prolonged stress or exposure     to very intense life threatening experiences, such as those encountered in combat or other     hazardous duty deployments can increase the risk of developing mental health problems     including depression, anxiety, or post-traumatic stress disorder (PTSD). One possible way to     minimize the effects of these stressful experiences on Service members is to strengthen their     emotional flexibility, adaptability, and capacity to cope with adversity before they find     themselves faced with such situations. To fill this need, the investigators propose to     provide the military with a web-based program that focuses on enhancing Awareness Training, a     core set of trainable awareness skills that collectively include the capacity to understand,     perceive, control, and use emotions effectively.      While the previous pilot program was successful in some ways, it needs further research     before it is ready for widespread use. The investigators therefore propose to build upon the     existing strengths already in the program and redesign the weaker modules to be more     effective. Over the course of a four-year study, the investigators propose to develop this     program. The proposed Awareness Training program is brief, web-based, easily accessible, and     sufficiently focused such that it could be completed by large numbers of military personnel     with minimal time burden, leading to rapid enhancement of awareness skills. Such a program     could have a significant effect in promoting resilience, interpersonal functioning, and brain     health among Service members and their families, while reducing the likelihood of mental     health problems among those returning from exposure to potentially traumatic experiences.      The central hypothesis is that a set of well designed and targeted training modules     addressing core awareness ability domains will significantly enhance measured awareness     skills, will translate into improved performance on militarily relevant metrics, and will     lead to better mental and emotional health, as well as well being during stressful situations     and subsequent cognitive processing.   "
43089|NCT02721667|"     Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension are     at high risk for cardiovascular disease and death. Most of this risk is mediated through high     blood pressure (BP). However, seniors are also at risk for side effects from BP lowering     medication. These can be life threatening and costly. Therefore, BP monitoring is required to     ensure BP levels are in the recommended range (neither too high nor low).      Home BP monitoring can be used to ensure that BP is in the right range and is recommended for     all patients with high BP. Studies in other health care systems show that, to optimally     perform home monitoring, the readings should be teletransmitted (electronically sent to the     care provider). Additional studies indicate that BP control improves when health care     providers (usually pharmacists or nurses) are specifically assigned to review teletransmitted     BP readings and, using protocols, make therapeutic adjustments. However, a study needs to be     conducted within the Canadian healthcare system to prove that telemonitoring±case management     is cost-effective. In addition, proof that seniors consider telemonitoring to be usable and     acceptable is required.      The investigators will conduct a 200 patient randomized trial in community-dwelling seniors     that will compare home BP monitoring alone to telemonitoring plus case management, to     comprehensively assess cost-effectiveness, usability, and acceptability. Our partners include     TeleMED, a medium sized Canadian technology company with a wealth of experience in medical     data management and transmission; Pharmacare, which will provide case-management services.     The study will take place in seniors' supportive living residences; by virtue of residing in     these institutions, these seniors have complex care needs. This intervention, if effective,     cost-effective and safe, can be widely implemented.   "
43090|NCT02721654|"     The aim of PLUS is to conduct a multi-centre, blinded, randomised, controlled trial (RCT) to     determine whether fluid resuscitation and therapy with a balanced crystalloid solution     (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid     resuscitation when compared with the same treatment using 0.9% sodium chloride (saline)   "
43091|NCT02721641|"     This study is designed to provide continued access to intravenous (IV) Herceptin and to     evaluate long-term outcomes and overall safety in participants with stable disease and human     epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who     have completed a prior study with IV Herceptin.   "
43092|NCT02721628|"     Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus   "
43093|NCT02721615|"     About a thousand people a year in the United Kingdom survive a spinal cord injury but are     left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims is     more than half a billion pounds. We propose that after spinal cord injury, cord pressure at     the injury site rises, damaging the spinal cord further by secondary ischaemia. The value of     measuring and reducing cord pressure after spinal cord injury is unknown.      The injured spinal cord is compressed by bone malalignment and cord swelling. Current     management involves realigning and fixing the bony fragments using metal screws, rods and     plates. We hypothesise that: 1. Bony realignment alone does not adequately decompress the     swollen cord, which remains compressed against the surrounding dura. 2. That duraplasty     reduces intra spinal pressure more effectively than bone realignment alone. 3. Localised     hypothermia reduces intra spinal pressure and improves metabolism.      We will develop a novel method to measure cord pressure and metabolism at the injury site     after spinal cord injury and determine whether the cord pressure rises, for how long, and     with what impact on spinal cord metabolism.      This is a pilot study to find out whether spinal cord pressure and metabolism can be measured     after spinal cord injury and whether they are effected by treatment choices.   "
43094|NCT02721602|"     The current study proposes to study the feasibility and acceptability of the Families     Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed     with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful     recruitment, measurement and randomization of patients and their families will provide data     for our aim of assessing feasibility. Patient and family participation in the intervention     and feedback via the post-intervention surveys will provide data for our aim of     acceptability.   "
43095|NCT02721589|"     This is an open-label, single center, non-randomized, dose escalation phase I trial to     evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors The     primary objective is to assess safety and tolerability of SHR-1210 and identify recommended     phase II doses of SHR-1210 in patients with advanced solid tumors   "
43096|NCT02721576|"     This is a perspective, multicenter,single arm, open label, Phase 2 study to evaluate the     efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in     patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary     objective (ORR) will be done as defined in the protocol.   "
43097|NCT02721563|"     This is a perspective, multicenter,randomized controlledtrial,Phase 2 study to evaluate the     efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in     patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary     objective (ORR) will be done as defined in the protocol.   "
43098|NCT02721550|"     This is a perspective, multicenter,single arm, open label, Phase 2 study to evaluate the     efficacy and safety of treatment with CMNa combined with preoperatie concurrent     chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma .     Analyses of primary objective (pathologic Complete Response) will be done as defined in the     protocol.   "
43102|NCT02721498|"     This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF)     patients from the Royal Brompton Hospital, London investigating outcome measures used in     airway clearance trials.      Each participant will attend the research facility for two visits. Participants will be     randomly assigned to the order that they perform the study sessions. Visit A will involve a     period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of     airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.      Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS),     lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a     supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the     session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected     throughout the ACT or rest sessions and for 30 minutes after each of these sessions is     completed. Questionnaires asking patient views on the OMs will be completed at the end of     each study visit.      Analysis will be based upon differences in outcome measures and in-between study days.   "
43114|NCT02721342|"     Most chronic kidney diseases have a progressive evolution characterized by the gradual loss     of glomerular filtration rate (GFR), electrolytic imbalance, reduced erythropoietin synthesis     and activation of vitamin D. On many occasions, the progressive deterioration of renal     function occurs, even when the etiologic factors responsible for the kidney disease are     treated and/or eliminated as a result of an auto-sustained mechanism of inflammation and     fibrosis. Moreover, chronic nephropathies are often associated with high blood pressure and     increased urine protein excretion, being both risk factors of progression toward kidney     failure. Many clinical studies have shown the efficacy of antihypertensive therapies,     particularly the blockade of renin-angiotensin system, to lower the abnormal urinary protein     excretion. Moreover, control of blood pressure and proteinuria slow the rate of renal     function decline and in some cases even lead to recovery of kidney function avoiding the need     for renal replacement therapies. The set of measures to achieve these results encompasses the     term of renoprotective therapy. However these achievements have been obtained in the     setting of clinical trials, and need confirmation in the daily clinical practice.      To this purpose a standardized multidrug intervention model that aims at normalizing the     excretion of urinary proteins and stabilizing the renal function has been developed for the     outpatient-clinic and named Remission Clinic.      The applicability of this protocol is aimed for all nephrology and diabetology centers.     Through the use of a dedicated database computer network, it will be possible to share     clinical, laboratory and treatment data, recorded for each patient enrolled in the Remission     Clinic program. With this system, it will be possible to verify if the multidrug approach of     the Remission Clinic will allow to improve the clinical course of chronic proteinuric     nephropathy. All participants (centers) may access to the Remission Clinic website developed,     updated and maintained by the Department of Bioengineering of the Mario Negri Institute,     Bergamo, Italy.   "
43103|NCT02721485|"     Salt fluids are used extensively for acutely ill patients who are admitted to hospital. Two     salt fluids commonly used are Normal Saline and Ringer's Lactate. Both are used to rehydrate     patients, restore fluid volume and help stabilize blood pressure and failing organs. Both     salt fluids have been used for several decades. Until recently, it was thought the fluids are     essentially equivalent other than some minor differences related to the concentration of salt     components (sodium and chloride) and buffers (Ringer's Lactate has lactate as a buffer).     Recent data suggest that salt fluids containing less chloride like the Ringer's Lactate,     cause less acid in the blood, less kidney failure, and less death. However, the studies to     date are small and weak in their design and it is possible that there are no important     differences that affect patients. Hence, the research team will conduct a robust pragmatic     clinical trial where several academic and community hospitals will be randomized to use     either Ringer's Lactate only or Normal Saline only for a period of three months. The trial     will yield high quality and robust data to determine if Ringers Lactate reduces death and     re-admissions to hospital. Before embarking on this large-scale trial, it is important to     conduct a smaller (pilot) trial to evaluate if the larger trial will be feasible and not too     costly. In this small trial involving no less than 4 hospitals, the investigators will     determine how well the fluid interventions are adhered to in each hospital, record how long     it takes to receive approval from research ethics boards and be ready to start the study. The     investigators will also record challenges and develop solutions related to the operations of     the trial, and describe important clinical and outcome data essential for the design and     planning of the large trial.   "
43104|NCT02721472|"     The purpose of this study is to evaluate the relationship between plasma DNA levels and     micro- and macro-circulatory vascular remodelling in patients with sickle cell disease   "
43105|NCT02721459|"     The main purpose of this study is to determine the maximum tolerated dose (MTD) and     recommended phase II dose (RP2D) of XL888 when administered orally with vemurafenib plus     cobimetinib in participants with BRAF V600 mutated melanoma and to evaluate the safety and     tolerability of this combination.   "
43106|NCT02721446|"     The purpose of this study is to find out which types of written stroke messages may help high     risk stroke patients take action to improve their health.   "
43107|NCT02721433|"     The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs.     4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal     events within the Canadian Health Care System. This study will use an integrated consent     model that involves oral consent rather than a written informed consent writing process as     the study is comparing standard schedules and not a new administration schedule.   "
43108|NCT02721420|"     Background and rationale: Children hospitalised with severe anaemia in Africa are at high     risk of readmission or death within 6 months after discharge. No strategy specifically     addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria     chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in     children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect     was in addition to the effect of insecticide-treated bednets. There is now need to design and     evaluate effective delivery mechanism for PMC within the health system.   "
43129|NCT02721147|"     The central goal of this study is to examine the feasibility, acceptability, and preliminary     efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes,     and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility,     acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers     exist that limit participation in intensive sexual QOL interventions for breast cancer     survivors, an innovative secondary aim will investigate the perspectives of study-eligible     patient candidates who opt out of participating in the pilot trial. We expect that we will be     able to identify the participation barriers and intervention preferences of breast cancer     survivors with sexual concerns who opt out of the intensive trial in order to inform the     development of different interventions for future study.   "
43109|NCT02721407|"     The goal of this clinical trial is to study the feasibility and efficacy of     anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating     recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells.     Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically     against cancer cells, has emerged as a promising therapeutic strategy. Among the many     emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell     malignancies have demonstrated remarkable potential. CARs combine the variable region of an     antibody with T-cell signaling moieties to confer T-cell activation with the targeting     specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to     MHC down regulation by tumors. However, defined by the recession of evaluable lesions, the     persistence and efficacy of CAR-T cells are still restricted by the target selection.     Previous clinical studies largely utilized CD19 for the in vivo targeting of CAR-T cells,     which preferentially become refractory or resistant due to the heterogeneity of lymphoma.     This clinical investigation is to test a hypothesis whether anti-CD22 CAR-T cells work more     effective in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells.   "
43110|NCT02721394|"     The current project aims to assess the feasibility of conducting Functional Communication     Training in the UK with a small sample of young children (aged under 9) in an NHS setting.     Two delivery formats will be assessed in order to demonstrate the feasibility of conducting     FCT via different delivery methods within an NHS context. Participants will be four children     aged under 9 who have an identified intellectual / developmental disability and display     either self-injury, property destruction, or aggression at home. In addition, one family     carer per child will be coached to implement the intervention, either following researcher     intervention, or from the beginning. Data will be collected on challenging behaviour,     communication responses, family carer confidence in managing behaviour, fidelity of     intervention implementation, family quality of life, and acceptability of the intervention.   "
43111|NCT02721381|"     The specific objectives of this project are to conduct a randomized control trial to examine     the effect of a novel, telehealth parent training intervention for children with autism     spectrum disorder (ASD), ImPACT Online, on parent and child outcomes. The investigators will     compare the benefits of the self-directed and therapist-assisted delivery formats, and     examine moderators and mediators of treatment outcomes. The investigators anticipate that     both the self-directed and therapist-assisted models of ImPACT Online will be effective     methods for teaching parents to use evidence-based intervention strategies and for increasing     parent self-efficacy compared to a web-based information control group. Participants will be     randomly assigned to one of three groups. One-third of participants will be in the     therapist-assisted group; one-third will be in the self-directed group; and one-third will be     in a web-based information control group.   "
43112|NCT02721368|"     The purpose of this study is to determine whether Neuramis® Volume Lidocaine is effective in     the temporary restoring the mid-face volume.   "
43117|NCT02721303|"     This study plans to learn more about how age and weight impact appetite and food intake.     Specifically, this study is being done to see whether age and obesity impact appetite and the     brain's response to food. In this study the investigators will be evaluating how participants     brains respond to food images as well as your food-related behaviors and hormones. The     investigators will be comparing older individuals aged 65 to 85 years who are normal weight     compared to those who are obese. The Investigators will then compare older aged individuals     to younger adults aged 21 to 45 years.   "
43118|NCT02721290|"     In this study, we will be comparing two approaches to the femoral block. The first or     classical approach and one that is the most popular in our institution is used by combining     ultrasound guidance and neurostimulator to do the block. The second is performed with the     ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and     injecting. The primary endpoint of the study is the sensitive cutaneous block distribution     using both techniques.   "
43119|NCT02721277|"     Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable     to absorb adequate enteral nutrients secondary to insufficient intestinal length or function.     In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1     g/kg/day which often limits the growth capacity of parenteral nutrition-dependent infants.     Inadequate growth is directly related to poor neurological outcomes, failure to facilitate     mechanical ventilation, and less growth of the neonate's already damaged intestine.     Ultimately, these outcomes can lead to severe disability and death. To mitigate these     deleterious effects and optimize growth, parenteral nutrition-dependent infants with     cholestasis who are not adequately growing on 1 g/kg/day of soy-based lipid emulsion must     have a greater intake of lipids to meet their needs for weight, length, and head     circumference growth.      SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides     essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less     susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain     triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish     oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and soy-based     lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic infants.     SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day. Because     this product includes both omega-6 and omega-3 lipids, it provides the benefits of the     omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid     requirements. Its use in situations in which growth is inadequate in babies who must be     restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase     their chances of both a good neurological outcome and survival.      The aim of this research study is to determine if the unique formulation of SMOFLipid will     cause less hepatic inflammation compared to soy only intralipids.   "
43120|NCT02721264|"     Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological     evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at     Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide     informed consent will be included in the study.   "
43121|NCT02721251|"     Obstructive sleep apnea (OSA) is highly prevalent among Veterans, and is associated with     significant mortality and multiple morbidities. Available treatments have had limited     effectiveness in treating OSA and alleviating associated morbidity. The investigators'     previous research found a reduction in OSA severity of approximately 25% following modest     exercise training. That this effect occurred independent of weight loss raises the exciting     possibility that exercise combined with weight loss could reduce OSA by at least 50% and have     unique health benefits for OSA patients. Following screening and baseline assessments, 90     overweight Veterans ages 18-60 years with OSA will be randomized to one of three 16-week     treatments: (1) exercise training; (2) 10 % weight loss; and 3) exercise + weight loss.     Changes in OSA and related morbidity will be compared between treatments.   "
43141|NCT02720991|"     A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of     sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.   "
43122|NCT02721238|"     Consecutive cirrhotics who present to emergency department of Institute of Liver & Biliary     Sciences with documented or suspected sepsis induced hypotension will be randomized to     receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At     admission, all patients will undergo physical examination and baseline investigations to     identify site of sepsis. The aim of study is to compare the efficacy of using 20% human     albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial     pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial     pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20%     albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the     intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence     of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after     one week will be studied.   "
43123|NCT02721225|"     More than 20 million infants worldwide, representing 16 per cent of all births, are born with     low birth weight, 96 per cent of them in developing countries. Bangladesh having one of the     highest incidence rate (21.6%) in the world.The short-term consequences of LBW is 12 times     higher perinatal mortality. It is estimated that LBW causes 60 to 80 % of neonatal deaths.     For the survivors, the effects are long lasting and largely irreversible. Infants born LBW     are at 2-4 times greater risk to develop acute diarrhea, pneumonia or acute respiratory tract     infection than their normal birth weight counterparts. Adults born with LBW suffer increased     risk of high blood pressure, coronary heart disease (CHD), non insulin dependent diabetes     mellitus, obstructive lung diseases, or renal damage.      Genitourinary (GU) infection, as a major risk factor for low birth weight deliveries     affecting a very large number of women both in the industrialized and the developing world.     In Bangladesh, there was a high incidence of UTI in 21-25 years age group (44.61%). The     bottom line for GU infection is that lactobacilli, healthy bacteria lose their dominant.     Recently, the protective role of the commensal microbiota has come into focus for its     infection-inhibiting function. Lactobacilli that colonize the gastrointestinal tract or     vagina can either significantly modulate the colonic microbiota by increasing the number of     specific prebiotic bacteria such as lactobacilli and bifidobacteria or reducing undesired     intestinal colonization of pathogenic bacteria. Prebiotic like Fructooligosaccharide (FOS) is     known to promote growth of normal healthy flora like lactobacilli (LAB). FOS supplementation     in early pregnancy improves vaginal or gut microflora with LAB , which will control GU     infection and improve pregnancy outcome and promote infant's growth and development   "
43124|NCT02721212|"     54 inpatients participants were randomly divided into two groups (experimental and     conventional). Individual of experimental group were treated according to an established     protocol for ARMEO Spring (30 minutes/session with Armeo Spring and 30 minutes/session with     conventional treatment 5 days/week for 6 weeks). The conventional treatment consists of     passive and active assisted mobilization of the upper limbs, traditional training based on     the Bobath concept. Inpatients of control group were treated with conventional treatment with     training session of 60 minutes 5 days/week for 6 weeks. All patients were evaluated by a     blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at     follow up 6 weeks later (T2). We assessed the impact on functional recovery (Functional     Independence Measure - FIM scale), strength (ARM Motricity Index-MI), spasticity (Modified     Ashworth Scale-MAS) and pain (Numeric Rating Pain Scale -NRPS).   "
43125|NCT02721199|"     Acute exacerbations of COPD contribute to significant morbidity and mortality in the United     Kingdom (UK). The ability to assess response to treatment during exacerbations that require     hospitalisation would allow clinicians to better risk stratify patients for higher or lower     level in-patient or out-patient care. Current methods of detecting clinical deterioration are     validated in general medical populations and may lack sensitivity and specificity in patients     with respiratory morbidity. The use of respiratory muscle EMG to assess neural respiratory     drive (NRD) has been demonstrated to be a predictor of readmission in patients admitted to     hospital with COPD. The technique has been applied on 'spot' readings of limited duration due     to the need for hand analysis of the data. It has been performed by a trained clinical     physiologist who removed any interference data and standardised the data gathered. New     automated software allows for longer periods of observation, mostly unsupervised, and as a     result, the NRD measurements are more likely to be affected by various sources of     variability. The influence of clinical and physiological factors as they occur during routine     clinical management, such as administration of bronchodilator medication, time of day of     readings or proximity to chest physiotherapy, are not yet understood. This trial is designed     to gather data to better understand these relationships with NRD.   "
43126|NCT02721186|"     The overall aim of this study is to determine the effectiveness of two rounds of mass drug     administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD)     primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on     Unguja Island, Zanzibar.   "
43127|NCT02721173|"     The combination therapy of retinoid and clindamycin for acne is preferred because it targets     multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby     improving outcome. Literature review reveals that till date there is no published comparative     study assessing safety and efficacy of tazarotene plus clindamycin and adapalene plus     clindamycin. So the present study has been designed to compare these two combination therapy     in acne vulgaris.   "
43128|NCT02721160|"     The government of Burundi is implementing a new financing scheme in health centres. The     objective is to provide additional financial compensations to health centres on the basis of     their performance in nutrition activities: it consists in the introduction of criteria     focusing on malnutrition prevention and care activities in the existing performance based     financing (PBF) system.      The general objective of this study is to assess the effects of this new financing scheme, to     document its impact and to study the chains through which it occurred. This study will     provide key evidence for countries with an existing PBF scheme and confronted with     malnutrition problems on the appropriateness to extend the strategy to nutrition services. If     this impact evaluation brings positive results, this may have implications for the global     fight against malnutrition.   "
43142|NCT02720978|"     Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of     8-10% of births. Since the duration until delivery is important in avoiding the risk of     complications, several studies have been performed in order to understand what is the     preferred way to manage this condition of PROM in women that are not in active labor. In the     largest random study that has been performed 20 years ago, there was found an advantage for     labor induction with oxytocin over labor induction with Prostaglandin or waiting. However,     the most important component - the BISHOP score, that affects the decision of the labor     induction way, was not reported and was not taken into consideration.   "
43130|NCT02721134|"     Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and     prompt implementation of the etiological treatment. The bacterial infections are the most     common and are associated with high morbidity and mortality. Diagnosis is based on the     detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor     antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often     based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination     of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis,     gram + and gram - are circulating and often present in small amounts; they can be detected by     sensitive and specific tools following a pretreatment of the blood sample (innovative     technology Bacti-DIAG).      The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a     suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary     objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams)     in the patient's care including diagnosis and treatment.      All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS)     sepsis suspects will be included: in addition to the samples taken for routine care of the     patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or     SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas     under the ROC curves for the detection of gram + and gram will be calculated and associated     detection limits will be determined to meet the objectives of the study.      It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and     analyze biometric and biological data based on the subsequent evolution of the patients. The     care of patients will be blinded to the results of the new biomarker Bacti-DIAG   "
43131|NCT02721121|"     The purpose of this study is to compare the clinical outcomes depending on catheter ablation     strategy for persistent atrial fibrillation. After randomization, investigators will conduct     circumferential pulmonary vein isolation alone in a group, and additional posterior box     isolation and anterior linear ablation in the other group. Investigators will compare     clinical recurrence rate, complication rate, and procedure time, etc.   "
43145|NCT02720939|"     Specific Aims:        1. To generate induced-pluripotent stem cells (iPSCs) from peripheral blood mononuclear          cells (PBMCs) isolated from whole blood of ASD probands and healthy controls.        2. To derive neural progenitor cells (NPCs) and neurons from iPSCs of ASD probands and          healthy controls and compare differences between patients and healthy controls to          investigate the cellular phenotype of ASD and uncover the pathophysiology of the          disease.   "
43146|NCT02720926|"     Standard 3+3 dose escalation design of TKI258/XELOX in advanced gastric/gastro-oesophageal     and colorectal cancer.   "
43147|NCT02720913|"     The COR-KNOT technology (LSI SOLUTIONS, Victor, New York USA) was developed to replace suture     tying with a faster procedure during surgery. While preclinical studies confirmed the speed     of COR-KNOT use, no clinical studies have quantitatively compared the speed of suture     fixation delivered by the COR-KNOT device with the speed of conventional hand-tied knots.     COR-KNOT is expensive, costing 189 $ per application. Given this added expense, it is     important to quantify the time-saved by application of this technology.   "
43148|NCT02720900|"     The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota     and metabolites in children with autism spectrum disorders.   "
43132|NCT02721108|"     Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on     women's lives and the (National Health Service) NHS.      CPP may be related to internal organs, the nervous system or psychological factors and is     often difficult to treat. Surgery and drugs have risks and side effects, are expensive and do     not help all patients.      Psychological treatments have potential to improve CPP but are not consistently available.     Mindfulness meditation teaches people to accept their sensations and emotions in the present     moment. This can help to accept pain better, which enables patients to focus on daily     activities and improve their quality of life. It has been shown to help in headache, back     pain and depression. Usually mindfulness meditation is taught by attending courses for 8     weeks.      The investigators want to find out in a full-scale trial if mindfulness meditation, taught by     using a smartphone app, can help CPP patients.      In preparation for this full-scale study the investigators will conduct the MEMPHIS study to     answer the following questions:        -  How many patients are willing to participate?        -  How often they use the app?        -  Reasons for not wanting to participate/not using the app -           - Which health questionnaires are the most useful ones?        -  How many patients will be required for the full-scale trial?      Patients will receive the usual treatment and be divided into three groups        -  using a 60-day mindfulness meditation app,           -- using comparison app with progressive muscle relaxation but no meditation        -  no app      Patients will complete health questionnaires, may be asked to comment in a focus group and     record pain, medication changes, surgery and emergency medical visits   "
43133|NCT02721095|"     evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl     compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting     hypokalemia   "
43134|NCT02721082|"     The purpose of this study is to determine the impact and efficacy of a new approach to     smoking cessation treatment versus the traditional approach.   "
43135|NCT02721069|"     This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1   "
43136|NCT02721056|"     The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of     NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and     activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.   "
43137|NCT02721043|"     The purpose of this study is to test the safety, tolerability, and immunogenicity of     Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic     malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence.     Each patient's tumor is sequenced and peptides that correspond to the tumors are made. These     peptides combined with the adjuvant Poly-ICLC (Hiltonol®, Oncovir) make PGV001. The adjuvant     Poly-ICLC is added to boost the immune response to the peptides and together will expand     immune cells to target cancer.   "
43138|NCT02721030|"     This is a prospective cohort to describe clinical characteristics, predictors of poor     outcomes both during hospitalization and at home, functional status, and quality of life     among patients aged 13 years or more, consecutively admitted with acute decompensated heart     failure at Mbarara Regional Referral Hospital.   "
43139|NCT02721017|"     The purpose of this study is to determine whether cryoanalgesia provides better pain control     for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.   "
43140|NCT02721004|"     This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid     arthritis participants receiving tocilizumab as per the product label.   "
43143|NCT02720965|"     The main objective of this study is to compare the efficacy of continuous nerve blocks with     single injection in terms of perioperative patient satisfaction after scheduled orthopedic     ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain     Catastrophizing Scale (PCS) and type of surgery.      Secondary objectives comprise the assessment of pain, readmission rates, patient     mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about     quality of recovery will be performed on day 1, about quality of life on day 45 and presence     of neuropathic pain will be screened at 3 months. An economic study will also be conducted,     including work resumption at 3 months.      This is a multicentric prospective study. Three hundred patients will be randomized in two     parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump     versus single local anesthetics injection.      The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary     endpoints will include assessment of pain, opiates consumption, sensitivity and motricity     scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and     heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery     (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4)     at day 90.   "
43144|NCT02720952|"     The study will be conducted in a total of 24 subjects before their 6th birthday, requiring     replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or     hypopituitarism.      The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged     between 2 and < 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to <2     years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only     if again no safety concerns emerge, then 6 neonates aged from birth to <28 days will be     enrolled (Cohort 3).      The decision to continue after each cohort will be based on the recommendation of an     Independent Data Monitoring Committee (IDMC).   "
43149|NCT02720887|"     The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers.     However, their impact on health remains little evaluated.      Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and     toxicity in the fetus has been studied in many animals. The investigators seem interesting at     first to establish the mineralogical load in the amniotic fluid in humans.      The first objective of this study is to determine the mineralogical NP load, quantity and     composition, in the amniotic fluid in pregnant women.   "
43150|NCT02720874|"     This research will evaluate a multifaceted patient-centered intervention in a sample of     socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that     capitalizes on a partnership between the extended rheumatology healthcare team and each     patient in order to promote understanding, uptake and adherence to the principles of     treat-to-target strategy. The primary hypothesis of this study is that the addition of a     multifaceted intervention incorporating integrated multidisciplinary rheumatologic care,     nurse-directed self-management education and supportive follow-up, and technology-based at     home RA symptom monitoring and reporting to clinical guideline-based care will increase RA     remission rate at 6 months.   "
43151|NCT02720861|"     To explore the prevalence of genetic polymorphism on RNF213 rs112735431 gene in     non-cardioembolic ischemic cerebrovascular disease in Thai patients.   "
43152|NCT02720848|"     This is a randomized clinical trial examining the use of a stiffening wire to increase depth     of maximal insertion during double and single balloon enteroscopy.   "
43153|NCT02720822|"     Breathlessness is an overwhelming symptom affecting tens of thousands of Australians every     day. For many people, it persists even when all the underlying causes have been optimally     managed (chronic breathlessness). In these circumstances, it often occurs at rest or with     minimal exertion.      Evidence from a number of clinical studies suggests that a small, regular dose of morphine     helps to reduce safely the sensation of breathlessness. However, it is not well established     which patients derive more benefit and what is the net clinical effect of this treatment     (weighing benefits and harms).      This is a phase III, multi-site, randomised, double-blind, placebo-controlled trial with     patients with chronic obstructive pulmonary disease (COPD) and severe chronic breathlessness     which will explore several important questions:        -  Are regular, low doses of morphine at four possible doses over 3 weeks more effective          than placebo at improving breathlessness?        -  Does increasing the dose in people who already are experiencing some benefit provide          even greater reduction in worst breathlessness?        -  Does the medication have any effect on daily activity and quality of life?        -  What are the common or serious side effects of this intervention?        -  Does the benefit from the medication outweigh the side effects it produces?        -  Are there specific characteristics of people who are more likely to receive benefit from          extended release morphine?      Participants will receive once daily extended release morphine (plus laxative, docusate with     senna), or placebo (placebo laxative) in addition to their usual medication for up to 3 weeks     at increasing doses.      Participants will have a medical interview and physical examination to collect some general     health information, and baseline measurements including; daily activity, symptoms, and     quality of life. A small amount of blood may be required to check eligibility. Further blood     samples may be taken at week 1 and 3 to enable testing on how individuals respond to opioids,     further consent will be obtained for these samples.      Data on benefits, side effects, and medical care will be collected during comprehensive     weekly visits. Participants will also fill out a simple diary twice daily for weeks one to     three of the study, and for one day each week during an optional 3 month extension stage.      The outcome of this study may enable better management of symptoms and activity in people     COPD with medicines that are shown to be effective and safe.   "
43154|NCT02720809|"     Health2016 is a general population cross-sectional study aimed at completing af monitoring     program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar     studies have been performed in 2006, 2010, and 2013.   "
43155|NCT02720796|"     Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived     xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The     purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model     in predicting patient clinical response to the same drug treatment.   "
43156|NCT02720783|"     The primary objective of the study is to evaluate the local tolerability of the new     Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone     products and placebo. Pharmacokinetics of the study products after single and multiple     applications o.d. for 3 days, overall local and general tolerability, safety and comfort of     use will also be evaluated.   "
43157|NCT02720770|"     This study evaluates the effect on height of a two year treatment with growth hormone in 19     children with X linked hypophosphatemic rickets.   "
43193|NCT02720302|"     The present study is a public health project with the aim to treat overweight in children     9-11 years of age. After the first consultation the children are randomized to either     continue the treatment at The Child Obesity Clinic, Child Department or to have the following     2-3 consultations on distance with Lync. Last visit for all children is on the Child Obesity     Clinic after approximately 12 months. Follow up after at least 1 years will be performed.   "
43160|NCT02720731|"     The combination of motor disabilities, chronic pain, cognitive disabilities limiting the     possibilities of communications and repeated potentially painful rehabilitation, exposes     patients with motor disabilities to a high risk of induced pain in the specialized     establishments. Induced pain is difficult to detect and is therefore little assessed and     treated. Currently, little is known about the prevalence and conditions of occurrence of such     induced pain as the clinical characteristics of patients (children, adults, severity of     disability), the types of care and the nature of the institutional admission (medical or     medico-social). Secondary objectives are to identify risk factors related to the induced pain     and patient characteristics, as well as to create an easy-to-use weekly continuous pain     assessment tool in a routine clinical set-up.      All daily life procedures or treatment carried out in children and adults with motor     disability are collected for 5 days and 1 night. Collected data are clinical and demographic     characteristics of patients, the intensity of the pain assessed by the care professional     (FLACC-r) or the patient himself (VAS).      Clinically, the uncomfortable and painful procedures and risk factors for pain identified by     this study will help the development of targeted preventive measures within institutions.     Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain,     leading them to observe the behavior of patients, to admit any pain related to an act of     daily life, and to ask for the medical profession to anticipate the painful experience.   "
43161|NCT02720718|"     Background      Excess weight and obesity is the fifth leading risk factor for global death. Bariatric     surgery is considered as the only effective long-term treatment for morbid obesity.     Laparoscopic Roux-en-Y gastric bypass is one of the best surgical procedures, since it     achieves excellent long-term results with a low complication rate. Intestinal anastomosis is     a very complex and time-consuming procedure in laparoscopy, mainly due to the difficulties of     knotting the suture in a limited working area. Barbed sutures may enhance this procedure by     eliminating the need for knot tying.      Objective The aim of this study is to compare the safety and efficacy of knotless barbed     sutures (Stratafix) and continuous sutures (Vicryl) for closing the gastrojejunal and     jejunojejunal anastomosis in obese patients undergoing gastric bypass.      Study design      This is a prospective randomized study. Patients will be randomly assigned to one of two     groups: traditional suture group or knotless suture group. Randomization will be realized by     sealed envelopes according to a computer-generated sequence of random numbers, which will be     opened for the surgeon just before starting the anastomosis. During the surgery the     gastrojejunal and jejunojejunal anastomoses will be performed with a stapler (Echelon 45     Endopath) and closed with a traditional (Vicryl) or knotless (Stratafix Unidirectional)     suture. The same surgeon, experienced and specialized in laparoscopic gastric bypass     technique, will perform all procedures.      Study population      Two hundred patients undergoing laparoscopic Roux-en-Y gastric bypass.      Main study parameters/endpoints      The primary outcome measure will be the rate of anastomosis-related complications (leakage,     bleeding, gastric fistula, anastomotic stenosis) at 4 weeks and at 6 months post-op (safety).     The secondary outcome measure will be the time spent on closing the gastrojejunal and     jejunojejunal anastomosis (efficacy).   "
43162|NCT02720705|"     The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in     preschool children undergoing tonsillectomy operations in the prevention sevoflurane     agitation.   "
43163|NCT02720692|"     The primary objective of this study is to evaluate the safety and tolerability of N1539 in a     variety of post-surgical conditions.   "
43164|NCT02720679|"     The purpose of this study is to collect and store samples and health information for current     and future research to learn more about the causes and treatment of blood diseases. This is     not a therapeutic or diagnostic protocol for clinical purposes. Blood and bone marrow as well     as health information will be used to study and learn about blood diseases by using genetic     and/or genomic research. In general, genetic research studies specific genes of an     individual; genomic research studies the complete genetic makeup of an individual.      It is not known why many people have blood diseases, because not all genes causing these     diseases have been found. It is also not known why some people with the same disease are     sicker than others, but this may be related to their genes. By studying the genomes in     individuals with blood diseases and their family members, the investigators hope to learn     more about how diseases develop and respond to treatment which may provide new and better     ways to diagnose and treat blood diseases.      Primary Objective:        -  Establish a repository of DNA and cryopreserved blood cells with linked clinical          information from individuals with non-malignant blood diseases and biologically-related          family members in order to conduct genomic and functional studies as outlined in the          secondary objectives.      Secondary Objectives:      Utilizing the biorepository, investigators aim to:        -  Identify novel mutations that associate with disease status in individuals with          unexplained non-malignant blood diseases.        -  Identify modifier genes in individuals with defined monogenic non-malignant blood          diseases.        -  Identify genetic variants associated with treatment outcomes and toxicities for          individuals with non-malignant blood disease.   "
43165|NCT02720666|"     This study is an open and single-center Phase I clinical research on patients with advanced     pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to     determine the safe and reasonable dosage and dosing regimen.   "
43166|NCT02720653|"     Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which     affects 12.5% of the adult population across all racial and ethnic groups. Previous research     has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with     complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals     in the United States with chronic rhinosinusitis. This proposed investigation will be used to     predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights     into mechanisms of olfactory dysfunction in this population.   "
43167|NCT02720640|"     The aim of this single-centre study is to assess the safety and efficacy of the Retina     Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual     impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The     study is sponsored by the University of Oxford and funded by the National Institute for     Health Research (UK).   "
43168|NCT02720627|"     This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression     potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve     hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris.     Adrenal suppression effects and systemic safety are an important safety concern. The current     study is designed to investigate these potential concerns under maximal use conditions.   "
43169|NCT02720614|"     The purpose of this study is to evaluate the safety of accelerated hypofractionated     three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy     for patients with unresectable stage III non-small cell lung cancer.   "
43170|NCT02720601|"     Biliary tract cancers that progress after first line treatment can be difficult to treat.     There is a great need for an effective, tolerable, easy to administer second-line regimen.     Previous early phase studies demonstrated that the combination of two chemotherapy drugs,     irinotecan and capecitabine had activity in this setting. The goal of this study is to     determine whether this drug combination, as a second-line treatment, can improve progression     free survival in patients with biliary tract cancers.   "
43171|NCT02720588|"     Specific Aims: This study aims to examine the hypothesis that individuals with Autism     spectrum disorder (ASD) and their unaffected siblings shared alterations in gray and white     matter volume and their associated intrinsic functional connectivity, to build upon limited     literature about neuroimaging endophenotypes of ASD. The investigators also aim to test     whether these shared differences are associated with behavioral autistic traits.   "
43172|NCT02720575|"     The objective of this study is to test the bioavailability of vitamin D in bread.   "
43182|NCT02720445|"     The purpose of the study is to see if daily transdermal nicotine is able to produce a     significant cognitive, clinical and functional improvement in participants with MCI. Neuronal     nicotinic receptors have long been known to play a critical role in memory function in     preclinical studies, with nicotine improving attention, learning, and memory function.      The study will enroll 300 participants for a 2 year period. Participants will be randomized     (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day,     or placebo skin patch.   "
43173|NCT02720562|"     Resting state functional MRI is widely used for studying brain functional networks. However,     in-scanner head movement and other non-neuronal noise can disproportionately bias     connectivity estimates, despite various preprocessing efforts. To address these issues, the     technique combining data acquisition with multiecho (ME) echo planar imaging and analysis     with spatial independent component analysis (ICA), called ME-ICA, has been develop to     distinguish BOLD (neuronal) and non-BOLD (artifactual) components based on linear echo-time     dependence of signals, and has been demonstrated to successfully remove non-neuronal     confounds. Nonetheless, such research approach has never been applied in psychiatric     populations. The study aims to fill in the gap as shown in the following.   "
43174|NCT02720549|"     Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is     a common problem which influence poor outcome in subjects undergoing valvular heart surgery.     The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart     surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote     ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury     in previous animal studies and stoke patients. Therefore, the investigators are trying to     evaluate the clinical effect of remote ischemic postconditioning on postoperative renal     dysfunction in subjects undergoing valvular heart surgery with bypass.   "
43175|NCT02720536|"     Extended evaluation of deferasirox film-coated tablet (FCT) formulation   "
43176|NCT02720523|"     A Phase 2b/3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Japanese     Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of     Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an     Inadequate Response to csDMARDs.   "
43177|NCT02720510|"     This is a multicenter, open-label, randomized phase II study which will enroll 112 newly     diagnosed symptomatic multiple myeloma patients in a 1:1 fashion. Patients will be enrolled     at approximately 20 centers in the United States.      Patients will undergo stem cell mobilization with plerixafor plus Granulocyte Colony     Stimulating Factor (G-CSF), according to investigator discretion, after 4 cycles of induction     therapy. Study treatment interruption for stem cell collection may not exceed 30 days. All     patients will receive one additional cycle of study treatment after stem cell collection and     then proceed to autologous transplant using melphalan 200mg/m2(140mg/m2 for patients > 70     years), as conditioning.      After Autologus Stem Cell Transplant( ASCT), patients still on study will initiate     maintenance therapy within the 60-120 day period following ASCT, provided they have adequate     blood count and clinical recovery. Patients in the RVD arm will initiate maintenance therapy     with lenalidomide alone, and patients in RVD-panobinostat arm will receive lenalidomide +     panobinostat maintenance. Lenalidomide will be dosed orally at 10mg/day continuously in both     arms, increasing to 15mg/day after the first 84 day cycle. Panobinostat will be dosed at 10mg     three times a week, every other week. Total planned duration of maintenance therapy will be 3     years.      Patients will remain on study treatment until they complete the maintenance phase, or until     they experience disease progression, unacceptable toxicity, or at the discretion of the     Investigator.   "
43178|NCT02720497|"     Objectives and Rationale: With up to 20% of U.S. service members returning from Iraq and     Afghanistan with PTSD symptoms, a critical need exists for treatments that are both effective     and efficient, enabling the greatest number possible to be treated to remission. As a highly     efficacious treatment and the one with the most scientific support, Prolonged Exposure (PE)     is recommended by the Institute of Medicine and being rolled out by the Departments of     Defense and Veterans Affairs to help heal our war fighters' psychological wounds. A major     barrier to that roll-out, however, is that PE is typically delivered in 90-minute sessions.     This is difficult for military mental health providers, who because of large patient loads     and pressure to see as many patients per day as possible, limit therapy sessions to 60     minutes. The primary aim of this randomized clinical trial is to determine whether PE     sessions can be reduced to 60 minutes without compromising the treatment's high success rate.     Preliminary evidence suggests that patients may greatly benefit from PE even when the time     spent recalling and recounting the trauma memories during sessions (a key procedure called     imaginal exposure) is shortened to fit into a 60-minute session. To test this hypothesis, the     trial will enroll 160 San Antonio-area active duty service members who will be randomly     assigned to receive PE treatment with 60- or 90-minute sessions. In an additional effort to     learn more about how PE helps patients recover - and thereby gain insights to further enhance     treatment benefit - the study investigators will examine what causes reductions in PTSD     symptoms during PE by examining self-reported and physiological markers (e.g., heart rate     reactivity) between the two treatment groups.      Research Applicability and Impact: If PE can be shown to maintain high success rates with     shorter sessions, more military clinicians could offer this powerful therapy, as it would fit     within time constraints of their heavy workload. This would potentially help thousands of our     nation's warriors recover from the devastating psychological effects of PTSD and maintain     their military careers, heal hurting relationships, and reengage in meaningful life     activities. This study would further benefit the military and the general public by enhancing     the readiness of our Armed Forces and reducing the public cost of service members' lost work     time or veterans' disability benefits. Overloaded VA providers and even civilian therapists,     who often limit sessions to 60 minutes due to insurance reimbursement requirements, may also     be more likely to utilize the shorter treatment format, increasing access to evidence-base     care for veterans and civilians. In addition, insights from the study's examination of     biomarkers and underlying mechanisms of PE could be used to enhance care for service members,     veterans, and the general public. Study risks are minimal, as a small proportion of patients     may see temporary symptom increases as they deal with traumatic memories, but this is part of     the recovery process. Patients receiving the shorter treatment sessions potentially may     realize a lower level of treatment benefits, but preliminary evidence suggests there is good     reason to believe their treatment will be equally as successful as those receiving     traditional PE.   "
43179|NCT02720484|"     The primary objective will be to assess overall response rate of nivolumab in patients with     metastatic or locally advanced adrenocortical carcinoma. Nivolumab was recently approved by     U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma, non-small     cell lung cancer and renal cell carcinoma. It is considered investigational for the treatment     of advanced or refractory adrenocortical carcinoma. Investigational means that the drug is     not approved by the USFDA or not approved for the indication under investigation. Nivolumab     could shrink adrenocortical carcinoma but it could also cause side effects. Researchers hope     to learn if the study drug will shrink the cancer and hopefully to relieve symptoms that are     related to the cancer.   "
43194|NCT02720289|"     This study compares a video-based social learning method to the traditional didactic method     as a new way to teach caregivers about child passenger safety, including how to install a car     seat. Half of the caregivers will attend the video-based social learning class, while the     other half will attend the traditional didactic class. The investigators hypothesize that the     video-based social learning method will lead to an equal or greater increase in caregiver     child passenger safety proficiency when compared to the traditional didactic method.   "
43195|NCT02720276|"     The purpose of this exploratory study is to investigate how a predetermined outdoor walking     program (12 weeks) is best delivered to individuals with stroke over 18 years, either by     smartphone and the Short Message Service (SMS) or video link.      Furthermore, the aim is to investigate how the study design works in practice and determine     the effects of the outdoor walking exercise program in combination with a leg exercise on     physical functioning (walking capacity, gait speed, mobility and grip strength).   "
43180|NCT02720471|"     Clinical study, comparative, prospective, interventional, randomized, single-center,     single-blind The fast resumption of the walking after surgery of total prosthesis of hip     (PTH) requires an effective analgesia from the immediate post-operative period. In France,     whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional     anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of     the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States,     the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon     supplanted the techniques of traditional ALR. However, no French study compares the IAL with     the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us     that it is more effective in terms of post-operative analgesia with Analog Visual Scales     decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the     upright posture in bipedal support as well as the resumption of the walking would be earlier.      The main objective is to show that the post-operative analgesia by local peroperative     infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block     associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of     hip, with decrease of the consumption of morphine within first 72 post-operative hours.      The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest     and with the mobilization during various times (in post-surgery care room, then at H4, H8,     H12, H24, H48, H72), the period between the end of intervention (out of the operating room)     and the first support by the upright posture in bipedal support), the period between the end     of intervention and the resumption of the walk, the satisfaction of the patients at the exit     of the hospital, the duration of hospitalization after the surgical operation and the     possible unwanted events (systematic toxicity of the local anesthetics, the infection of     prosthesis, disease thromboembolic venous) during the hospitalization.   "
43181|NCT02720458|"     Persistent insomnia has a high prevalence in French general population affecting between 15.8     % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP)     who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line     treatment. French Health authorities recommend restricting the consumption of both hypnotics     to no more than 4 weeks, considering their potential adverse effects (memory impairment,     altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence.     However, it appears that a majority of patients become chronic users. Therefore,     discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge     due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound     insomnia).      Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT)     principles improve sleep and daily life quality leading to hypnotic taper and maintain of     hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4     components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene     education. This therapy is dependent on a therapeutic alliance between practitioner and     patient. Unfortunately, there are an insufficient number of trained CBT experts especially in     France.      The implementation of an internet-delivered self-help program based on time-in-bed     restriction and stimulus control may be an issue within the context of general practice.      Online programs based on CBT principles have been proved to be effective in improving the     sleep and daytime functioning in this population, but the studies were realized in small     patients groups.      Investigators hypothesis is that a simple and internet-delivered short-term program based on     sleep restriction therapy and stimulus control (following to a GP consultation) may     facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia     disorder still reporting sleep complaints in comparison with a tapering alone (no access to     the self-help program).   "
43199|NCT02720224|"     This study is being conducted to further understand the elimination pathways, metabolite     profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).   "
43183|NCT02720432|"     This current study proposes to analyze the feasibility and effects of the two most used     therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in     very young infants (less than one year) with perinatal stroke and with a high risk to develop     hemiplegic CP.   "
43184|NCT02720419|"     The purpose of this study is to evaluate the relative effectiveness and safety of Synergy     stent compared to other drug eluting stents.   "
43185|NCT02720406|"     The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two     different doses in pediatric patients undergoing tonsillectomy operations   "
43186|NCT02720393|"     Participants will be randomly assigned to either regular or no-carrageenan prepared diets to     determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin     A1c is the primary outcome measure.   "
43187|NCT02720380|"     This study has the aim to assess the effectiveness of the Buteyko method as an adjunct     therapy in the treatment of children with asthma.   "
43188|NCT02720367|"     The purpose of this study is to determine if GemRIS, an investigational drug-delivery system     is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive     bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors     (TURBT)   "
43189|NCT02720354|"     [11C]-dimethyl-diphenyl ammonium ([11C]-DMDPA) - A Phase I, Open‑label, Safety and     Tolerability, Radiation Dosimetry, Biodistribution, First‑in-Human Study of a Novel     11C‑labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging   "
43190|NCT02720341|"     Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the     ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke,     spinal cord injury)   "
43191|NCT02720328|"     The purpose of this study is to investigate the preventability of serious adverse drug     reactions (ADRs) related to the use of direct oral anticoagulants (DOACs). The investigators     also aim at identifying the underlying causes of these preventable ADRs. The endpoint     measurements will be compared with a group of patients taking vitamin-K antagonists (VKAs).     For this purpose, a protocol for a prospective observational study was developed. The study     was approved by the Ethics Committee of the CHU UCL Namur (site Godinne) and the Cliniques     Universitaires Saint-Luc. Patients admitted to the emergency department of these two teaching     hospitals with a thrombotic or a bleeding event while under DOAC or VKA are included. After a     comprehensive medication history, the appropriateness of prescribing is evaluated, using an     adapted version of the Medication Appropriateness Index. Causality, severity and     preventability of adverse events are assessed by two pharmacists and two hematologists using     predefined scales. Second, for cases of serious and preventable ADRs, semi-structured     interviews are performed with general practitioners to understand the underlying causes of     medication errors. Based on the results, risk-minimization strategies that specifically     target the problems encountered in clinical practice will be proposed.   "
43192|NCT02720315|"     Acute musculoskeletal (MSK) injuries, including strains, sprains or contusions, are a common     reason patients seek emergency care. Pain control is an essential component of treatment.     Within the orthopedic literature, there is robust body of research supporting the use of     cryotherapy for post-operative patients and injured athletes. However, within the emergency     department (ED), studies have been focused on pharmacologic analgesia. The absence of     evidence on optimal method or impact of ice therapy for acute MSK injuries contributes to     inconsistent practice patterns that may impede symptom control or increase narcotic usage.      The specific aim of the ICED investigation is to evaluate the effectiveness of intensive     cryotherapy for the treatment of pain due to acute MSK injuries treated in the ED. Secondary     outcomes include length-of-stay (LOS), patient satisfaction, and narcotic usage.   "
43197|NCT02720250|"     Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on     vascular health in overweight and/or hypertensive patients.      However, there is a lack of studies showing the effect of everyday consumption of omega-3     fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in     healthy population.      This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on     microvascular reactivity and lipid profile in young healthy subjects.   "
43198|NCT02720237|"     The purpose of this study is to compare the effectiveness of two interventions [a Brief     Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy     (MET+CBT) Intervention], against each other and with an assessment-only control, in improving     both alcohol- and HIV-related outcomes, among hazardous and heavy drinking HIV-infected     antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.   "
43200|NCT02720211|"     Nearly all migraine sufferers report sensitivity to light during a headache and a significant     proportion of sufferers report light sensitivity between attacks. Light is also a common     trigger for migraine headaches. Spectacle lenses that have been treated with tints and     spectacle lenses that have been treated with thin-films have both been shown to reduce light     sensitivity and headache in patients with migraine. At this time, it is not clear which     spectacle lens treatment is superior. The purpose of this trial is to determine if there's a     significant, therapeutic advantage to either spectacle lens treatment. Both treatments could     be a novel, non-invasive adjuvant in the treatment of migraine.   "
43201|NCT02720198|"     This study's primary objective is to compare the efficacy and tolerability of switching     patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new     treatment (quetiapine) to the participants' existing treatment with people diagnosed with     depression (major depression disorder).      The secondary objective is to examine the response and remission rates following the switch     from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with     examining changes in neurocognitive and apathy measures after the switch.   "
43202|NCT02720185|"     Primary Objective:      To determine if dasatinib, an inhibitor of the Src family kinases, can prevent the nuclear     translocation of the epidermal growth factor receptor (EGFR) in Stage I-III, nuclear EGFR     positive, triple negative breast cancers (TNBC).      Secondary Objectives:        1. To examine the safety and tolerability of dasatinib in patients with operable TNBC        2. To explore potential intracellular mechanisms which impact dasatinib effect on cellular          localization of EGFR in operable TNBC.        3. To examine the pathologic complete response (pCR) rates to standard neoadjuvant          chemotherapy in nEGFR+ TNBC        4. To examine breast cancer recurrence rates and patterns of metastatic recurrent in nEGFR+          TNBC   "
43203|NCT02720172|"     The overall objective of this two-group randomized controlled trial is to gather preliminary     evidence on the efficacy and safety of early postoperative exercise for improving disability,     pain, and general physical health in patients after anterior cervical discectomy and fusion     (ACDF) surgery. Our central hypothesis is that an early home exercise program (HEP) performed     within the first six weeks after surgery will decrease disability and pain and improve     general health, through increases in physical activity and self-efficacy and reductions in     fear of movement. The results of our randomized trial will advance research on postoperative     management for patients with cervical spine surgery and provide evidence in line with a     value-based healthcare approach for optimizing outcomes.   "
43204|NCT02720159|"     The purpose of the clinical study is to characterize the efficacy and safety of a     Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform     for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus     allowing a proper biobarrier around the implant.   "
43205|NCT02720146|"     Poor corneal epithelialization problem can be found in a lot of ocular surface disorders,     including limbal insufficiency, dry eye, chemical burn and neurotrophic disorders. Delayed     corneal epithelialization under any circumstances can lead to corneal infection, corneal     melting, corneal opacity, pain or blurred vision. It is thus important to develop     pharmacological methods to promote corneal epithelial wound healing in those patients.     Previously, various epitheliotrophic growth factors, autologous serum, cord blood serum, etc.     have been proved to be effective in promoting corneal epithelial wound healing. However,     those topical agents have the drawbacks including the difficulties during preparation,     expensive price, non-standardized quality and the risk of contamination during preparation.     It will be clinically important to find other blood derivatives which are effective,     convenient for use, stable in quality and being cheap.      During the recent few years, various platelet related blood derivatives have been proved to     contain a lot of epitheliotrophic growth factors, and can promote wound healing. Among those     products, platelet lysate has the benefits of being commercially available. It can avoid     the complicated producing procedure, and has stable quality. Although platelet lysate has     been widely used in various medical fields, especially in culturing mesenchymal stem cells,     its potential in promoting corneal epithelial wound healing has not been proven. The purpose     of this project is to explore the possibility of using platelet lysate to treat patients with     poor corneal epithelialization problem, and compare its epitheliotrophic ability with other     blood derivatives. The cultured human corneal epithelial cell line will be used for all     experiments, and will be cultured with media containing different blood products: (1) control     group without blood derivatives, (2) fetal bovine serum, (3) human serum, (4) platelet lysate     commercial product—UltraGro, (5)platelet lysate commercial product---PlatMax. MTS assay will     be used to measure proliferation ability. Scratch-induced directional wounding assay and     Boyden chamber chemotaxis assa will be used to measure cell migration. Scanning electron     microscopy, transmission electron microscopy, transepithelial electric resistance (TEER) and     immunohistochemistry with junctional proteins will be used to measure cellular     differentiation. Through these experiments, the investigator aim to understand whether     platelet lysate can replace other blood derivatives, and be used for treating patients with     corneal epithelialization problem.      Beside, current medications in dry eye are all manufactured, transported and used in the form     of liquid form. However, it is more disturbing in transporting, commercializing, storing and     the limitation of expiration date for current medications compared with powder form     medications. Therefore, improving the convenience of utilizing and storage without at the     expense of the efficacy of blood-derivatives has become a critical issue. Our study also     aimed at trying to produce platelet-related derivatives (including platelet lysate) and human     serum into the form of dry powder and resuspended it with preservative-free artificial tears.     The investigator would compare the epitheliotrophic ability of the liquid form of blood     derivatives and the powder form of blood derivatives.      Since human serum is needed for comparison , the investigator proposed this IRB to collect     human serum from healthy volunteers。   "
43206|NCT02720133|"     Ramadan Fasting has multiple effects on the variation of hematological and biochemical     parameters.   "
43207|NCT02720120|"     This study is in two parts and will evaluate the safety, tolerability and efficacy of     escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination     with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation     study, at one of the following dose levels of ocrelizumab [400, 1000, 1500, and 2000     milligrams (mg)]. In Part 2, participants will be randomized to explore tolerability and     efficacy of doses which have been shown to be tolerated in Part 1.   "
43208|NCT02720107|"     The purpose of this single visit extension study is to explore immune status in RRMS patients     treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be     compared to short-term changes in immune status (baseline to month 6) after treatment start     with fingolimod as assessed in the original Biobank study (CFTY720DDE01).   "
43209|NCT02720094|"     This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB     LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender     women who have sex with men (MSM and TGW).   "
43210|NCT02720081|"     The purpose of this trial is to compare the safety, tolerability, and efficacy of adding     MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving     montelukast alone. Participants will have a specific genetic marker for clinical efficacy of     MK-1029.   "
43211|NCT02720068|"     This is a safety and pharmacokinetics study of MK-4280 as monotherapy and in combination with     pembrolizumab (MK-3475) in adults with metastatic solid tumors for which there is no     available therapy which may convey clinical benefit. Part A of this study is a dose     escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in     combination with pembrolizumab. Part B is a dose confirmation design to estimate the     recommended Phase 2 dose (RPTD) for MK-4280 in combination with pembrolizumab in participants     with advanced solid tumors.   "
43212|NCT02720055|"     A randomised controlled trial to compare two different rehabilitation work books used in     patients with wrist fracture.   "
43213|NCT02720042|"     The purpose of this study is to collect additional data on safety and performance of Phasix™     Mesh in subjects requiring VHWG Grade 3 midline hernia repair.   "
43214|NCT02720029|"     Monitoring and quantification of reflux events in high risk critically ill inpatients and     lower risk general medical/surgical inpatients, with comparison to relevant clinical     variables.   "
43215|NCT02720016|"     Untreated posttraumatic stress disorder (PTSD) is a costly condition associated with     impairment in functioning across a host of psychosocial domains including occupational and     academic functioning, marital and family functioning, parenting, and socialization.     Impairment is not limited to Veterans with PTSD because the entire family is affected,     particularly the Veteran's intimate partner. PTSD symptoms can produce negative effects on     both members of the dyad. Despite the need for treatment, many Veterans and their families do     not access PTSD-related services due to a number of barriers to accessing care (e.g., living     in rural or remote areas where no specialty services exist, concerns about stigma around     using mental health services, limited clinic hours to accommodate patient schedules). The     objective of this study is to assess whether providing Cognitive-Behavioral Conjoint Therapy,     in which PTSD symptoms and intimate relationship functioning are addressed, to Veterans and     their romantic partners in their homes via clinical video teleconferencing leads to better     outcomes compared to office based treatment.   "
43218|NCT02719977|"     CX5461 is a new type of drug for many types of cancer, particularly cancers that cannot     easily repair damage to their cells. This may help to slow down the growth of cancer or may     cause cancer cells to die. CX5461 has been shown to shrink tumours in animals and has been     studied in a few people and seems promising but it is not clear if it can offer better     results than standard treatment.   "
43219|NCT02719964|"     The objective of this proposal is to evaluate the effectiveness of rehabilitation for visual     attention deficits in U.S. military service members across three programs: Visual Attention     and Working Memory Programs (UCR Games), Speech Pathologist-Directed Treatment, and General     Cognitive Rehabilitation Games (Lumosity).      In addition to the above prospective component, this study also has a retrospective component     in which archival data collected from routine clinical care will be examined for analysis.     The investigators hope to gain a better understanding of the unique and cumulative influence     different cognitive rehabilitation programs have on improving attention complaints in mTBI.   "
43220|NCT02719951|"     Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in     autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers   "
43221|NCT02719938|"     The objective of this study is to generate preliminary data for a large multi-site randomized     clinical trial of a model of palliative care consultation for patients with advanced     dementia, and for their family caregivers.   "
43222|NCT02719925|"     The goal of clinical trial is to evaluate the effect of one month of consumption of mineral     water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy     consumers having magnesium daily intakes below the recommended dietary allowance (RDA).   "
43223|NCT02719912|"     This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter     heart valve (THV) for mitral valve replacement in subjects at high risk for conventional     mitral valve replacement or repair surgery.   "
43224|NCT02719899|"     Background:      Researchers want to better understand the body s immune response to calorie restriction. To     do this, they are asking healthy volunteers to fast for 24 hours. Researchers will test     immune response before and after fasting.      Objectives:      To explore the benefits of calorie restriction on immune health.      Eligibility:      Healthy volunteers ages 21 to 37 with a body mass index between 22 and 29.      Design:      Participants will be screened with medical history, physical exam, and blood tests.      Participants will visit NIH after an overnight fast. Their baseline immune response will be     taken. They will give blood and urine samples. Then they will be given breakfast. This visit     will take about 2 hours.      Participants will fast (not eat or drink anything except water) for the next 24 hours. They     will return to NIH the next morning. Their immune response will be taken. They will give     blood and urine samples. Then they will be given breakfast. Their immune response will be     taken 3 hours later. They will give a blood sample. This visit will take about 4 hours.   "
43225|NCT02719886|"     The purpose of this randomized controlled trial is to compare the frequency of the diagnosis     of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week     intervals.   "
43226|NCT02719873|"     A study will carried out over a period of one year , all obese pregnant women as diagnosed     with BMI at the time of 1st ANC visit and before labor ,observation of events during both     intra-partum &postpartum periods it will be recorded.outcome will compared with normal other     pregnant women   "
43227|NCT02719860|"     The overall objective of this study is to determine the effect of high tea consumption on     biological markers of oxidative stress that mediate lung cancer risk.   "
43228|NCT02719847|"     The goal of this clinical research study is to compare the results of EBUS-TBNA with the     results of PET/CT scans to learn about the accuracy of these ways to find evidence of early     stage lung cancer.   "
43229|NCT02719834|"     Behavioral expressions, such as agitation and aggression, affect up to 90% of persons with     dementia and are a major source of patient and caregiver distress, nursing home placement,     anti-psychotic medication use, restraints, and increased health care costs. The purpose of     the research study is to investigate whether reducing pain reduces behavioral expressions of     Alzheimer's disease (agitation and aggression).   "
43230|NCT02719821|"     The goal of this project is to refine and evaluate the feasibility of a brief, behavioral     intervention to improve the recovery following hematopoietic stem cell transplantation     (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to     improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue,     and depression after HSCT. If the intervention is feasible and acceptable to patients, a     future study will test the effects in a larger trial, with the long-term goal of improving     the care and quality of life of cancer survivors recovering from HSCT.   "
43250|NCT02719561|"     Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer     patients. Despite this, there has been virtually no research evaluating treatment for     cancer-related fatigue in this young patient group. The investigators are undertaking a small     qualitative study to co-design a fatigue intervention, that will then be evaluated in future     research to assess its effectiveness.   "
43501|NCT02716259|"     The purpose of this study is to investigate whether basic periodontal therapy aim to reduce     subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, has     an impact on the vascular function of patients suffering from established cardiovascular     disease.   "
43231|NCT02719808|"     500 pregnant patients with HBeAg-positive and HBV-DNA> 106copies /ml who will do their     pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled     into the study. There will be five groups to be observed. Four groups are taking tenofovir to     prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus     treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine     infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked     by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta     after treating with tenofovir and explore the mechanism of tenofovir blocking HBV     intrauterine infection. The safety of Tenofovir will be assessed as well.   "
43232|NCT02719795|"     The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce     chronic pain at 3 months after modified radical mastectomy（MRM）surgery.   "
43233|NCT02719782|"     Hepatocellular carcinoma (HCC) recurrence rate is high among liver transplant patients, while     treatment measures are limited. This study plans to recruit 10 patients with Hepatitis B     virus (HBV) related HCC who underwent liver transplantation and are confirmed to have     recurrent HCC. The objective of the study is to assess the safety, tolerability and     effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target     population.   "
43256|NCT02719483|"     The purpose of this study is to determine whether radial extracorporeal shock wave therapy in     combination with traditional physical therapy is safe and effective for the management of     spastic plantar flexor muscles in patients with cerebral palsy younger than averaged three     years of age.   "
43234|NCT02719769|"     The Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood     Culture Identification & Antimicrobial Susceptibility Testing is designed to validate the     clinical performance of the Accelerate ID/AST System for positive blood culture     identification and susceptibility testing in a clinical setting. The data from this study     will be used to support the 510(k) submission for FDA clearance and global registrations of     the device intended for in vitro diagnostic use.   "
43235|NCT02719756|"     This study will test the hypothesis that early use of combination therapy with dapagliflozin     and metformin will provide good glycemic control with low glycemic variability and without     hypoglycemic episodes, and will be better tolerated than up-titration of metformin     monotherapy. The study will also correlate these benefits with glycated hemoglobin.   "
43236|NCT02719743|"     The purpose of this study is to assess the safety and immunogenicity of different     formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35     months of age.   "
43237|NCT02719730|"     This study will assess the impact of a randomized intervention aimed at increasing     consumption of whole grain foods among children from low-income households that participate     in the Special Nutrition Assistance Program (SNAP, or food stamps). A total of 60 obese     children (8 to 16 years) will be recruited from a clinical population (Healthy Eating Active     Living Program) at University of California San Francisco (UCSF) Benioff Children's Hospital     Oakland. Participants and their caregivers will all receive education about whole grain     foods, and will be randomized to either an intervention or control group. The intervention     group will receive a monthly reimbursement allotment of up to 10% of their usual SNAP benefit     for specific whole grain foods purchased during the three month study period. The control     group will not have the financial incentive for purchasing whole grain foods during the 12     week study period. The investigators will assess the feasibility of the intervention, the     impact of the intervention on household grocery purchases, and the impact on the child's     anthropometrics, dietary intake of whole grain foods (24-hour recall), and markers of     metabolic risk.   "
43238|NCT02719717|"     This research program consists of a prospective, multi-institutional Phase 2 trial and an     economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy     compared to traditional techniques.      It will be left up to the study credentialed surgeon investigator to decide the suitability     of PA branches for sealing. This will be decided intra-operatively based on anatomy, vascular     dissection and length as well as patient specific factors.   "
43239|NCT02719704|"     The main purpose of this study is to analyse the effect of a multicomponent intervention,     applied during one scholar semester, on body composition, strength, flexibility,     cardiorespiratory fitness, lipid and metabolic profile, and body image of students from sixth     to ninth grade. This is a non-randomized controlled design. Approximately 568 schoolchildren     of grades sixth through ninth were recruited from 2 public secondary schools in     Florianópolis, Brazil. The main component of the intervention entitled MEXA-SE (move     yourself) consisted of the implementation of three physical education classes per week with     aerobic exercises, strength and flexibility activities. In addition, play activities in     school recess, and educational activities on physical activity, sedentary behaviour, eating     habits and body image were performed. Data collection was performed before and immediately     after 14 weeks of intervention. The primary outcomes included the body composition, strength,     flexibility, cardiorespiratory fitness, lipid and metabolic profile, and body image. Other     variables included were: physical activity level, sedentary behaviour, and blood pressure     level. Other components of the lifestyle (e.g., eating habits), psychological (e.g.,     self-rated health) also were evaluated in the participants. Descriptive analysis, two-way     ANOVA for mixed models and ANCOVA will be applied for within and between comparison groups,     if the premises of this test are met. The level of significance for the study was 5% for     two-tailed tests.   "
43240|NCT02719691|"     This is a phase Ib study designed to evaluate the safety and toxicity of the combination of     Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in     patients with previously treated metastatic TNBC.   "
43251|NCT02719548|"     A prospective, randomized, 2-phase/crossover, single center premarket feasibility study. In     phase I the comfort will be assessed, the occurence and types of adverse events will be     recorded and the assessment how and if the different breast shield designs interact with the     lacting breast during pumping. Phase II takes place at home; assessment of adverse events     will be recorded and the assessment how the subjects perceives the comfort of the soft edge     breast shield during mid term use at home.   "
43252|NCT02719535|"     The aim of the proposed study is to investigate the predictive value of corneal biomechanical     properties in corneal reshaping therapy and the role of these parameters in determining the     amount of myopia reduction.   "
43241|NCT02719678|"     The effect of systematic health examinations and screening of the general population is under     debate. Recently, a large Danish randomized study found that systematic screening of risk     factors and lifestyle advice in the general population did not have a preventive effect on     coronary heart disease, stroke or all-cause mortality. However, there are still very few     completed randomized studies, and the effect on other diseases remains unclear. The purpose     is to investigate whether repeated health examinations with screening of various risk factors     in an unselected population prevent long-term incidence of ischemic heart disease, stroke,     total and cause-specific mortality, diabetes, dementia, chronic obstructive pulmonary disease     and various forms of cancer. A preliminary protocol was submitted and approved by the Danish     Data Protection Agency before the registry-based data on primary and secondary outcomes were     received by the investigator.   "
43242|NCT02719665|"     The purpose of this study is to understand the effects of fish oil supplement (containing     parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which     dose of the fish oil supplement is the most effective. The name of the fish oil supplement is     SPM Emulsion.   "
43257|NCT02719470|"     In order to explore the question how an intensive, goal-based and aerobic rehabilitation     treatment, addressed to act on motor and mental aspects, affects motor and functional     symptoms in PD patients with normal cognition and with different level of cognitive     impairment. Hypothesis is that a specific rehabilitation program based on motor-cognitive     training and repetition, can affect positively the rehabilitation outcome regardless of     baseline cognitive profile.   "
43258|NCT02719457|"     the aim of this study to assess the relationship and compare physiological response between     spot marching exercise test and 6 minute walk test in patient with chronic obstructive     pulmonary disease   "
43259|NCT02719431|"     The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the     pharmacokinetics of warfarin in healthy adults volunteers.   "
43970|NCT02710136|"     This research is being done to look at the body's response to cockroach extract, an allergen,     when sprayed into the nose. The spraying of the cockroach extract into the participant's nose     is called Nasal Allergen Challenge (NAC). The purpose of this study is to evaluate the safety     and tolerability of a intranasal cockroach extract given to participants with asthma.   "
43243|NCT02719652|"     Intracranial atherosclerotic disease (ICAD) is an important cause of ischemic stroke. The     occurrence of stroke caused by symptomatic ICAD is significantly different compared with     asymptomatic ICAD (19% vs 3.5%), suggesting that plaque vulnerability may be responsible for     the difference. Based on the previous high-resolution magnetic resonance vessel wall imaging     (HR-MRI) results, the investigators hypothesis that the feature of intracranial plaque     enhancement is an important imaging biomarker of plaque instability, which is closely related     to stroke. The investigators will establish the ICAD cohort and use HR-MRI to investigate the     composition, morphology and the enhancement pattern of symptomatic ICAD plaques. These     findings will correlate with biochemical markers, and stroke recurrence, in order to explore:        1. plaque characteristics and the enhancement features between symptomatic ICAD and          asymptomatic ICAD        2. the relationship between plaque enhancement and the composition of plaques;        3. relationship among enhancement features of symptomatic ICAD plaques, biomarkers with          different clinical significance,        4. evolution of enhancement features of symptomatic ICAD plaques under intensive medical          therapy.      The investigators aim to explore the correlation between vulnerable plaque stratification and     clinical outcomes, to explore the value of vascular responses in the pathogenicity of ICAD     vulnerable plaques, as well as to provide objective basis for the establishment of the     evaluation criteria of intracranial atherosclerotic vulnerable plaques.   "
43244|NCT02719639|"     Real-world data on the effects of a fixed-dose combination Long-acting beta agonists +     long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol     administered in a single device, in COPD patients who need treatment with two long-acting     bronchodilators, is not available. This is a self-controlled study design enrolling consented     COPD patients who will be treated with Spiolto Respimat according to the approved Summary of     Product Characteristics (SmPC).   "
43245|NCT02719626|"     Rutgers University will partner with the Meals on Wheels America (MOWA) and affiliated     agencies in five states to conduct a study designed to improve food safety nutrition and     emergency preparedness among homebound elderly recipients of home delivered meals (HDM). This     population is at increased risk for food borne diseases, as a result of unique physiological     and behavioral factors, and is particularly vulnerable to any disruptions in the food system     because of their lack of mobility.      A multi-method research approach will be used with a target sample of 1,000 MOWA homebound     elderly clients. Methods include the use of a novel UPC scanning technology that quickly and     comprehensively catalogues all of the food in the clients' homes, a home food safety audit,     and a face-to-face interview.      The goal of the study is to provide an improved understanding of the unique food safety     threats to this at-risk population, suggest easy, cost-effective ways of reducing known food     safety risk factors, and provide clear guidelines about the amount and types of food most     needed by this population in emergency situations. Dissemination of research findings and     recommendations will be done through a partnership with EDEN and MOWA, both of which have     national constituencies poised to act on the recommendations.   "
43246|NCT02719613|"     The purpose of this study is to continue to provide elotuzumab and/or other study drugs to     subjects who have participated on a prior protocol investigating elotuzumab who are not able     to receive commercial drug supply.   "
43247|NCT02719600|"     Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics.     Despite cognitive and motor difficulties, there is a possibility of intervention based on the     knowledge of motor learning. However, it is important to study the motor learning process in     individuals with DS during a virtual reality task to justify the use of virtual reality to     organize intervention programs. The aim of this study was to analyze the motor learning     process in individuals with DS during a virtual reality task. Methods: A total of 40     individuals participated in this study, 20 of which were with DS (24 males and 8 females,     ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender     to the individuals with DS. To examine this issue, we used software that uses 3D images and     reproduced a coincidence timing task.   "
43254|NCT02719509|"     This is a prospective observational study evaluating the diagnostic utility of cardiac     ultrasound in patients who present to the emergency department with undifferentiated chest     pain or shortness of breath. Emergency department providers will be interviewed before and     after the completion of a cardiac ultrasound to determine if the ultrasound resulted in any     changes in management. Other outcomes include determination of incidence of unexpected     findings.   "
43260|NCT02719418|"     The purpose of this study is to assess if accumulation of anti-Xa activity occurs after     repeated daily administration of prophylactic doses of tinzaparin in patients with severe     chronic kidney disease (CKD) requiring thromboprophylaxis for non-surgical conditions.      It is anticipated that tinzaparin used at a fixed dose for thromboprophylaxis in severe CKD     patients (eGFR ≤ 30 ml/min /1.73 m2) at risk for venous thromboembolism (VTE) will not     bioaccumulate at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level     between day 2 or 3 and day 5.   "
43261|NCT02719405|"     Primary Endpoint      -The percentage of subjects who develop tolerance to cow's milk protein by 12 months post     randomization to study formula.      Secondary Endpoints        -  Tolerance             -  The transcriptional profile of milk-specific T cells by clinical outcome.             -  Growth and Weight Velocity             -  Stool Consistency and Frequency             -  The estimated frequency of milk-specific T cells by clinical outcome.             -  The TCR diversity of milk-specific T cells by clinical outcome.             -  The milk allergen component-specific IgE, IgG4 and IgA by clinical outcome.        -  Safety             -  The rate of reported adverse events by treatment group.   "
43262|NCT02719392|"     The purpose of the Pilot Study Investigating the Efficacy of Minocycline and n-acetylcysteine     for Bipolar Depression is to test the effectiveness of minocycline, n-acetylcysteine, and     combined minocycline and n-acetylcysteine pharmacotherapy in order to fill the gap in     treatments for bipolar depression. The treatment of bipolar depression remains the greatest     unmet need in the management of this lifelong and chronic psychiatric disorder.   "
43263|NCT02719379|"     Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control     (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung     condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine     (PPSV23). The purpose of this study is to increase awareness of vaccination to late     adolescents with asthma and smokers (social aspect of study), and to recommend vaccination     (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled     in research to determine whether late adolescents with and without asthma (smokers) have     distinctive pneumococcal vaccine response patterns and whether such patterns are associated     with subsequent variance in asthma outcomes.   "
43264|NCT02719340|"     Although long-segment posterior spinal fixation might provide more rigid fixation, the     procedure increases perioperative morbidities in the elderly. The present study reviews the     results of short-segment decompression and reconstruction in thoracolumbar fragile fractures.   "
43265|NCT02719327|"     The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by     2050. Compared to the general population, Veterans have a greater risk of AD, likely in part     due to their increased incidence of traumatic brain injury, post-traumatic stress disorder,     depression, and other vascular-related health issues. Based on available data, 423,000 new     cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies     to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to     evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid     (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD     pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with     increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD     would be reduced by 50% in this population and could have a profound effect on Veteran     quality of life and healthcare costs.   "
43266|NCT02719314|"     Glucocorticoids remain to be among the most important and most frequently used     anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic     (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially     if higher dosages have to be given over longer periods of time. The available data describing     frequency and severity of these adverse effects are fragmentary. This statement is especially     true for glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory     rheumatic diseases or (in part) psoriasis(arthritis). The state of knowledge and scientific     data, being sparse, is partly conflicting and often derived from over-aged projects or     studies. Therefore, there are urgent needs to work on various current questions     systematically and at the highest scientific level possible. In order to address these needs,     we aim at collecting and analyzing disease- and bone-related data from patients with chronic     inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids, and to build a     respective GIOP-Databank. Patients will attend for diagnostics, and where necessary therapy     and follow-up of GIOP, according to current guidelines. Clinical, laboratory and instrumental     examination results from more than 1000 patients in the first three years of the project are     planned to be documented in a prospective database.   "
43267|NCT02719301|"     Study will compare measurements made with Necklace device for stroke volume/cardiac output     with values from a FDA-approved reference device. The gold standard that will be used is     Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the     Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the     reference device and the Necklace.   "
43268|NCT02719288|"     Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons     due to tendon adhesion complications. Functional recovery is compromised by limiting     post-operative range of motion, mobility, and can lead to considerable amount of     post-operative pain for the patient.      Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and     anti-scarring agent and promoting wound healing towards regeneration.      Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of     CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators     hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the     overall functional recovery of the patient.   "
43294|NCT02718950|"     The purpose of this study is to access liraglutide influence brown adipose tissue recruitment     and its thermogenic effect through hypothalamic activation in obese individuals.   "
43269|NCT02719275|"     Suicide is the 2nd leading cause of death for teenage youth in Canada, and every year tens of     thousands of young people engage in suicidal behaviors. Many young people manifest red-flag     behaviors in the digital realm before these incidents occur. The faceless nature of online     communication often emboldens youth to reveal details about their mental state: leaving     tell-tale signs or bread crumbs of their suicidal intentions or behaviors.      This research will examine the content of adolescents social media entries to find red flags     and detect patterns in social media interactions of adolescents that could be predictive of     subsequent suicide risk. The study participants will be patients admitted to Child and     Adolescent Psychiatry Emergency unit at BCCH, subdivided into two groups: those admitted due     to suicidal behaviors, and those admitted for non-suicidal behaviors. The text of social     media activity for the month prior to emergency admission of the two groups will be     collected, anonymized, and analyzed using text-analytic algorithms. The objective of the     study is to find patterns and indicators of social media entries, prior to admission, that     would have been predictive of suicidality.      The implications of successful outcome of this project for mental health care of children and     adolescents reaches well beyond the scope of this study. An objective method to predict risk     of suicidal behaviors in youth has application in almost all pediatric clinical settings. The     outcomes of this project will also serve as the foundation for further utilization of social     sensing technology to identify, predict, and prevent many other mental health crises in     children and adolescents.   "
43270|NCT02719262|"     The investigators recent study has found that ambient melamine exposure can cause the     increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in     this year, the investigators will examine whether the intervention by installing ventilation     in the workplace and providing personal protective equipment and education can decrease     ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury     such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).   "
43271|NCT02719249|"     Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or     transplant in west of France.   "
43272|NCT02719236|"     The purpose of this study is to compare the direct anterior approach and the direct lateral     approach in primary total hip arthroplasty, regarding the postoperative function and pain,     complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle     damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate     aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical     outcomes.   "
43273|NCT02719223|"     Rationale and objectives        1. Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with          less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis          (HD). The investigator will follow the hemodynamic parameters during the dialysis          sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.        2. By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate          the hemodynamic parameters and compare the two renal replacement treatment modalities,          and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.   "
43274|NCT02719210|"     All the children with acute liver failure who are candidates for transplant but have     constraints for transplant will be randomized either to receive standard medical therapy or     high volume plasma exchange along with standard medical therapy with the aim to assess the     effect of high volume plasma exchange on transplant free survival.   "
43275|NCT02719197|"     The primary purpose of this first-in-man study is to investigate whether a new drug for     neurological disorders is safe and well-tolerated when administered orally to healthy male     adults   "
43276|NCT02719184|"     The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125     COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125     COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ     genotype). Soluble and imaging biomarkers will be investigated addressing different aspects     of disease pathways postulated to be relevant for COPD progression.   "
43277|NCT02719171|"     The overall purpose of this trial is to assess clinical efficacy and safety of different     subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic     arthritis in order to select doses for further clinical trials.   "
43278|NCT02719158|"     This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled,     blinded study in which eligible subjects with either unilateral or bilateral acute otitis     media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12     mg OTO-201, or sham into the affected ear(s).   "
43279|NCT02719145|"     This cross sectional study will be carried out on 30 subjects who will be recruited from the     outpatient clinic of Chest Department, Tanta University Hospital.      They will be classified into 3 groups:      Group I: It will include 10 healthy volunteer subjects. Group II: It will include 10     asthmatic patients. Group III: It will include 10 COPD patients. miR-7, miR-20a, miR-21,     miR-22, miR-145 and miR-155 will be measured in serum samples from all subjects   "
43280|NCT02719132|"     This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV     study.      The primary objective is to compare the effect of dapagliflozin 10 mg once daily in     combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose     titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life     and treatment satisfaction in patients with type 2 diabetes.   "
43281|NCT02719119|"     Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are     obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of     EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in     order to compare the long-term results of EVL when performed at two different results from     monthly and bi-weekly treatments.   "
43282|NCT02719106|"     The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster     stent compared to other drug eluting stents.   "
43523|NCT02715960|"     In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by     Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases     invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on     the curative effect and find the relationships between genetic variants and the response of     Acitretin Capsules to treatment of Psoriasis Vulgaris.   "
43283|NCT02719093|"     Two common SNPs are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G     variant is regularly analyzed to characterize the exon 10 haplotype. In the last years, it     has been showed an influence of FSHR 2039 A>G on FSH levels, testicular volume, sperm     concentration and the total sperm count. A recent Cochrane review showed a beneficial effect     on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor     subfertility. Which FSHR polymorphism can benefit from FSH treatment is clinically very     important, in particular for what regards nonidiopathic patients. In many andrological units,     patients underwent adiuvant therapy with purified or recombinant FSH after varicocelectomy.     FSH treatment in patients after varicocelectomy could improve spermatogenesis, but there     aren't multicentric trials that confirm its validity. Usually, in our hospital only patients     with a morphologic aspect of hypospermatogenesis underwent therapy with purified or     recombinant FSH, because this therapy is not much useful in patient with Partial     Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to correlate     non responder patients who underwent FSH adiuvant therapy after varicocele surgery with a     p.N680S FSHR polymorphism. Moreover the investigators suppose that non responder patients     can beneficiate from a high-dose therapy with FSH. This is a prospective intervention study     in which are recruited males with OligoAstenoTeratozoospermic (OAT) and varicocele. The     partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar technique) and     needle aspiration testicular cytology (Foresta technique).   "
43284|NCT02719080|"     This study was designed to observe the cerebral state obtained via wavelet analysis     (HXD-I,Beijing Easymonitor Technology Co.Ltd, China) and evaluate the emotion in various     states in anesthesiologist and surgeon. And we also explore the association between the     characteristic of cerebral state and the emotion.   "
43285|NCT02719067|"     The significance of this project is the first longitudinal study to investigate the changes     of neurocognitive functions of children and adolescents with ASD and to identify the     potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging     technique (Tract-based automatic analysis, TBAA; multi-echo resting-state fMRI in addition to     single-echo resting-state fMRI). The success of this project will fill the gap of our     understanding of longitudinal changes of brain function by neuropsychological and imaging     approaches of ASD in Han Chinese in Taiwan, and is anticipated to facilitate the progress of     translational research in ASD.   "
43286|NCT02719054|"     Investments in Early childhood Development (ECD) programs produce higher economic return     through maximizing human potential. In developing countries over 200 million children do not     reach their developmental potential. Early nutritional support and psycho social stimulation     are essential for optimum development of children. Mothers are usually the key providers of     childcare.      Depression is reported as a leading cause of disease burden for women and maternal mental     health is identified as one of the major predictors of child development.      In Bangladesh, almost 60% children are at risk of poor development due to high prevalence of     Low Birth Weight (22%), under nutrition (41%), poverty, and sub-optimal stimulation. About     one third of Bangladeshi mothers suffer from depression. Early stimulation interventions in     Bangladesh have showed moderate improvements to children's development. This indicates that     there are still some gaps in the pathway to delivery. So, it is crucially important to     address maternal mental health along with any Early Childhood Development intervention at     community level to get bigger impact.      In Bangladesh mothers with sub clinical depressive symptoms often do not seek treatment due     to the stigma attached to it. Depressed mothers who do not receive treatment often fail to     provide sufficient stimulation and care for their children and in turn compromise benefits of     early stimulation programs. Rahman and colleagues (2008) tested an innovative model of     community-based depression management using Cognitive Behavioral Therapy in Pakistan and     reported improvement in maternal depression 6 months postpartum.      The study plans to combine the above treatment of depression with an evidenced-based Early     Childhood Development program to achieve maximum benefits on reducing maternal depressive     symptoms as well as improving children's overall development.   "
43287|NCT02719041|"     The main goal of this study is to employ a novel proteomic approach to identify predictive     tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R)     targeted therapy in epithelial ovarian cancer. It is expected that these predictive     biomarkers will be applied to increase the response rate in selected groups of patients.   "
43288|NCT02719028|"     Identified the efficacy of Antroquinonol (Hocena 50mg) in triglyceride, lipid-lowering and     fatty liver.   "
43289|NCT02719015|"     The goal of this clinical research study is to find the highest tolerated dose of rAd.CD40L     (also called ISF35) when given with pembrolizumab to patients with melanoma. Researchers also     want to learn if the highest tolerated dose of ISF35 and pembrolizumab can help to control     the disease.      The safety of this drug combination will be also be studied.   "
43290|NCT02719002|"     Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the     sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already     irreversible and the clinical picture may even continue to deteriorate for several years     after the end of synthetic antimalarial use. In opposition, the early termination of     hydroxychloroquine in patients showing recent alterations on the multifocal electroretinogram     (nfERG) allowed he reversibility of toxic damage over a six month period. It is therefore     critical to detect early retinal anatomic changes during retinotoxicity screening before the     occurrence of irreversible anatomical and functional consequences.      The usual patient monitoring consists of an annual eye examination, detecting subjective     functional abnormalities (visual acuity, color vision, central visual field testing) or     macular lesions (eye fundus). These abnormalities show a constituted infringement and do not     contribute to the early diagnosis of synthetic antimalarial maculopathy.      The mfERG is an objective examination, able to detect retinal damage whilst still reversible.     It is recommended during the annual monitoring and is, today, the gold standard for the     screening and diagnosis of synthetic antimalarial maculopathy. However, its realization is     time consuming, requires a good patient cooperation and is difficult to access due to the few     ophthalmology centers offering it. In practice, it is rarely done as a systematic annual     screening for patients on long-term synthetic antimalarial treatment. It is often limited to     second-line studies (for patients already showing functional or anatomical abnormalities)     whereas its interest lies in the detection of early lesions.      The Optical Coherence Tomography Spectral Domain (OCT-SD) is a non-invasive eye examination,     commonly used since nearly 10 years. A special image analysis provides a panoramic viewing of     the state of the photoreceptor layer, and a non-invasive detection of any anatomical changes,     even subtle, within this layer.      The concordance between the en face OCT and the mfERG in the screening of synthetic     antimalarial maculopathy is considered in this study.   "
43291|NCT02718989|"     The purpose of this study is to determinate whether the application of electric currents     produce changes in the excitability of alpha moto neurone. Moreover evidence whether the     effect of the electric currents can change the tone of the muscle under stimulation in     healthy volunteers   "
43292|NCT02718976|"     The main objective is to complete a double-blinded randomized controlled crossover trial of     lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance     imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy     volunteers.      The investigators will assess block procedure-related parameters, anatomical spread of local     anesthetic, and motor and sensory effects.   "
43293|NCT02718963|"     The purpose of this study is to determine the synchronized electrical stimulation device     effective in the treatment of dysphagia.   "
43296|NCT02718924|"     Investigators hypothesized that the impact of surgery in terms of inducing a hypercoagulable     state is more evident in morbidly obese pregnant women as opposed to their non-obese     counterparts. The aim of this study is to investigate the change in coagulation status of     morbidly obese and non-obese pregnant women following cesarean section delivery using     thromboelastometry. This observational study would also make it possible to calculate the     sample size for a future prospective controlled clinical trial to compare the incidence of     Hypercoagulability in morbidly obese parturients as opposed to their non-obese counterparts.     To the best of our knowledge, no other work has been done any in this area.   "
43297|NCT02718911|"     The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1     receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in     participants with advanced solid tumors.   "
43298|NCT02718898|"     The main purpose of this study is to evaluate the efficacy and safety of the study drug     ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.   "
43299|NCT02718885|"     The overall objective of the study is to examine the changes within the gut microbiome after     the supplementation of inulin and its effect on markers of mineral metabolism and bone     turnover.   "
43300|NCT02718872|"     This project is responsive to the identified gap of lack of tobacco cessation training     programs in Latin American & Caribbean countries. Currently, smoking rates in the Latin     American and Caribbean region are high, and previous surveys show that health professionals     do not have enough skills to help smokers to quit. In consequence, in absence of trained     health professionals, many smokers who visit health care services are under-treated. The     Fruitful Project aims to adapt an original on-line course developed in Spain to the reality     of the three Latin American countries (Bolivia, Guatemala and Paraguay) and disseminate     evidence-based tobacco cessation interventions among health care professionals.   "
43301|NCT02718859|"     The purpose of this study is to evaluate the safety and efficacy of the combined therapy     using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic     cancer.   "
43302|NCT02718846|"     A multicenter, randomized, open-label clinical study with a concurrent control group to     assess the effectiveness and safety of combined therapy with Isobide solution and Meniace     tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease   "
43303|NCT02718833|"     This research study is studying a combination of study drugs as a possible treatment for     relapsed and refractory Multiple Myeloma. The interventions involved in this study are     elotuzumab, pomalidomide, bortezomib, dexamethasone.   "
43304|NCT02718820|"     Squamous cell carcinoma of the head and neck, which accounts for 90% of head and neck     cancers, is the tenth most common cancer worldwide with over 650000 new cases per year. The     major risk factors for HNSCC development comprise alcohol and tobacco consumption. During the     last decades human papilloma virus infection (HPV) has been identified to contribute to the     development of oropharyngeal HNSCC in a subgroup of patients5. Standard treatment options     include surgery, (chemo)radiation and chemotherapy. Despite improvements of treatment     regimens the recurrence rate of stage III/IV disease after curative therapy is about 30-40%.     In locoregionally unresectable recurrent or metastatic disease palliative poly-chemotherapy     is the mainstay of therapy.The median survival time of these patients is 6-8 months. Based on     the results of the EXTREME study a combination regimen containing a platinum drug, 5     fluorouracil (5-FU) and weekly cetuximab has become standard of care in this setting. For     patients, who progressed after platinum based therapy, treatment options are scarce. Besides     platinum drugs, taxanes such as paclitaxel or docetaxel were shown to be of particular use in     this setting. Apart from that there has been increasing preclinical and clinical evidence     that immune-checkpoint inhibitors such as pembrolizumab might play a role in HNSCC. Thus, it     is the aim of this study to test if the combination of docetaxel and pembrolizumab after     platinum failure is an effective and safe regimen.   "
43305|NCT02718807|"     Pre-made rapid prototyping models will be used to increase patient education versus current     methodologies.   "
43306|NCT02718794|"     Teaching and learning of difficult airway management are considered to be an essential skill     in anesthesiology. As a result, doctors and nurses in anesthesia have to be vigilant in every     step including airway assessment, equipment preparation and strategic planning of the     process.      During the one-year training program, nurse anesthetist students intensively study theories     and practical skills in anesthesia, using manikins to living patients. Difficult airway     management has become a distinguished means in the training curriculum. In addition, the     educational tool in the anesthesia curriculum is typically simulation-based learning (SBL)     and problem-based learning (PBL) courses. As a result, we designed a cross-over study to     determine the learning achievement of nurse anesthetist students in difficult airway     management. The objectives were to study the learning achievement and relative growth of     knowledge of the two learning techniques: SBL and PBL.      Thirty-six nurse anesthetist students in Academic Year 2015, volunteered to join the study     project. After signing the consent form, they were randomly put into two groups: A (n = 17)     and B (n = 19). As designed by the cross-over study, students in group A attended SBL and     after 6 weeks, they focused on PBL, and vice versa for group B.      The 40-item, multiple choices exam was developed in regard to difficult airway management     guidelines. The correctness and appropriateness of the test (content validity) were     determined by three board-certified anesthesiologists. The try out of the test was performed     by 10 novice nurse anesthetists. The index of item objective congruence was 0.82 with Kuder     Richardson 21 of 0.8. The assessed criterion-referenced item difficulty and discrimination     index were 0.4-0.6 and 0.6-0.8 respectively.      The pretest (X1, X2) were post-test ((Y1, Y2) were performed in the consequence. The relative     growth of knowledge (G1, G2) was calculated as follows:      G1 = 100 (Y1 - X1) / (F - X1) % G2 = 100 (Y2 - X2) / (F - X2) %      Where F was the full scores of the learning course      Statistics analysis The test scores and relative growth of knowledge between the two groups     were expressed as mean and standard deviation. Comparison between the two groups was     performed by repeated measure ANOVA. Statistically significant differences were considered     when there was a p value of < 0.05 with a 95% confidence interval.   "
43318|NCT02718638|"     Oxidative stress and inflammation are cardiovascular risk factors in patients with chronic     kidney disease (CKD) undergoing hemodialysis (HD). Nuclear transcription factors play roles     in the coordinated expression of genes involved in inflammation, such as nuclear factor Kappa     B (NFkB) that increase the cytokines synthesis and Nuclear factor erythroid 2-related factor     2 (Nrf2) that increase the transcription of genes encoding enzymes of phase II detoxifying     and antioxidant enzymes. The aim of this study was to evaluate the effects of resistance     exercise program on the expression of transcription factors Nrf2 and NF-kB in HD patients.   "
43524|NCT02715947|"     To investigate the influence of genetic factors on the curative effect , to find the     relationships between genetic variants and the response of Methotrexate to treatment of     Psoriasis Vulgaris.   "
44015|NCT02709551|"     Aim of the study is the evaluation of the effects (psychological and physiological) of an     hrv-biofeedback training, a mindfulness training and a combination of both training methods     for stress reduction.   "
43307|NCT02718781|"     In recent years, Hong Kong has been undergoing rapid changes with macro social and economic     trends. The increasingly complex and diverse family structure contribute to concerns     regarding the well-being of families in Hong Kong, including their health, happiness and     harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the     increasing needs of promoting healthy active lifestyle among Hong Kong families. In this     connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on     FAMILY Holistic Health, will be conducted in order to increase the awareness of the     importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components -     train-the-trainers programs, community-based family interventions and public education     events. It is expected that trainees from the train-the-trainers programs will acquire     adequate skills to organize community-based health education programs effectively.     Participants of the community-based family interventions will gain knowledge on family     holistic health and live a healthy active lifestyle. Attendees of the public education events     will become more aware of the importance of FAMILY 3Hs.   "
43308|NCT02718768|"     This is a multi-center prospective observational study that will capture detailed information     about the treatment and long term outcomes of 450 patients with PNI resulting from upper     extremity trauma. The study will focus on a young adult population to include individuals     ages 18-65. Patients with PNI will be recruited during the hospitalization for initial     treatment of the upper extremity injury. Additional patients may be identified during clinic     visits for on-going treatment of upper extremity injuries as nerve injuries evolve or upon     referral from outside physicians. However, all eligible nerve injuries must be treated within     6 months of the initial upper extremity trauma. Outcomes will be assessed at 3, 6, 12, 18 and     24 months following diagnosis of the nerve injury. All assessments will take place in the     clinic and will include a patient interview and a brief exam to evaluate sensory and motor     function.   "
43309|NCT02718755|"     The goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and     erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed     or refractory hematologic malignancies. The safety of these drugs will also be studied.   "
43310|NCT02718742|"     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation     maintenance therapy works after cisplatin-based chemotherapy and surgery in treating patients     with high-risk bladder cancer. Maintenance therapy, such as paclitaxel albumin-stabilized     nanoparticle formulation, can help keep cancer from coming back after it has disappeared     following initial chemotherapy.   "
43311|NCT02718729|"     Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a     subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and     esophageal anastomosis than the other parts of the alimentary tract due to technical     difficulties in accessing these areas and their easily compromised blood supply.      Anastomotic leakage is the most feared complication following rectal resection and     anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with     mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of     patients.      Anastomotic leakage leads to increase the rate of secondary interventions, re-operations,     longer postoperative hospital stay, increased cost, and major impact on the patient's quality     of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy     with decreased the disease survival. Furthermore anastomotic leakage itself may increase the     local recurrence, a reduction in overall survival, and a large proportion of patients are     left with a permanent stoma.   "
43313|NCT02718703|"     Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of     a new Blood Glucose Monitoring System.   "
43314|NCT02718690|"     The purpose of this study is demonstrate the importance of density current of TENS in the     effect about H-reflex in healthy volunteers.   "
43315|NCT02718677|"     This NIS aims to evaluate the efficacy and the safety of ReFacto AF in the Standard     Prophylaxis Treatment of children with severe hemophilia A in Romania   "
43316|NCT02718664|"     Healthy volunteer food-effect study to determine the effect of food on uracil and     dihydrouracil levels in plasma   "
43317|NCT02718651|"     Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of     a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell     lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI)     crizotinib has produced remarkable results for ALK-positive patients, however the current     diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy.      The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next     generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC     patients. Furthermore, this test will be performed on blood samples, making it minimally     invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can     be employed as an easy accessible and comprehensive source of information to diagnose     ALK-positive disease, but also as a means of monitoring patient response during treatment.     Quantitation of the the amount of ALK rearrangement will give information about which     patients benefit from treatment and when treatment is no longer effective. The project will     be a multicenter study where blood samples will be collected every 6 weeks from patients     treated at four major hospitals in Denmark.      This study will benefit future patients with lung cancer, as it will improve both the     monitoring and evaluation of their treatment. Monitoring patients during treatment will     provide more knowledge of disease progression and the effect of ALK-TKI treatment,     contributing to a greater selection of patients, who will respond to treatment. This will     potentially allow effective treatment to continue longer than with conventional methods   "
43346|NCT02718274|"     The aim of this project is to investigate the feasibility, affordability as well as the     health and social impact of introducing HIV self-testing to rural communities through     existing community-based volunteer services.   "
43525|NCT02715934|"     Diabetes education is a very important part of diabetes care. Most people with diabetes     receive care in primary care practices where diabetes education is not always available. This     project tests a model designed to improve access to diabetes education services.   "
43502|NCT02716246|"     Open-label, dose-escalation clinical trial of scAAV9.U1a.hSGSH injected intravenously through     a peripheral limb vein   "
43319|NCT02718625|"     This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of     pressure ulcers for participants in a long-term care facility. After meeting study criteria,     participants will be randomly assigned for application of SANTYL® or SoloSite® to their     pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term     care setting, the removal of dead skin (debridement) with SANTYL® resulted in more     participants achieving complete debridement, more rapidly than when SoloSite® is used. The     goal of the present study is to confirm the results of the earlier study, demonstrating     superior debridement outcomes for pressure ulcers of patients in long-term care as compared     to ulcers managed with SoloSite®.   "
43320|NCT02718612|"     Uraemic sarcopenia is complex, and progressive . As older persons are particularly     susceptible to renal failure and this accelerates the physiological muscle wasting in this     patient group. Hence sarcopenia is an important factor of functional impairment in elderly     patients suffering from chronic kidney disease. On the other hand, overweight has become     increasing common in dialysis patients, and is paradoxically reported to be associated with     better survival. It remains unclear if adipose tissue in overweight in elderly dialysis     patients is a source of proinflammatory mediators, which could contribute to protein-energy     wasting (PEW), cardiovascular disease, and increased mortality. This study attempts to     explore the prevalence of Sarcopenic Obesity (SO) in a cohort of hemodialysis patients with a     more well defined criteria. In addition, this study aims to examine the association between     sarcopenia and SO with metabolic and cardiovascular risk factors in these patients.   "
43321|NCT02718599|"     To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during     hepatobiliary surgery   "
43322|NCT02718586|"     The aim is to test if serum level of myokines are associated with protein energy wasting,     inflammation and atherosclerotic vascular disease among Taiwanese dialysis patients. Some     novel myokines levels, anthropometric parameters, cardiovascular risk factors, and presence     of endothelial dysfunction will be examined in 250 subjects. The distribution of some     recently identified myokines such as irisin, myotatin etc levels will be studied and     correlated markers of malnutrition, endothelial dysfunction, inflammation and insulin     resistance. In the present study, the investigators will further follow and investigate     whether serum myokines levels are associated with long-term mortality from all causes and     from cardiovascular disease.   "
43323|NCT02718573|"     The objectives of the study are to determine the impact of interferon-free treatment for the     hepatitis C virus (HCV) on peripheral blood immune cell phenotype and soluble immune-related     proteins in blood, while controlling for genetic polymorphisms known to impact HCV-related     immune responses, and to determine the impact of the therapy on the emergence of     drug-resistant HCV. The study design is informed by the researchers recent investigations of     patients receiving HCV treatment. About 4% of patients who had not undergone liver     transplantation experienced hepatic decompensating or another serious event. There were     several cases of bacterial infection and two cases with elevated markers of autoimmune     processes. These events suggest that treatment altered immune responses. About 25% of     patients who had undergone liver transplantation experienced hepatic decompensating or     another serious adverse event. The long term goal is to understand the pathophysiology of     these complications and determine whether HCV treatment can cause an immune reconstitution     syndrome in susceptible patients, while improving antimicrobial defenses in others   "
43324|NCT02718560|"     The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in     Parkinson's Disease.   "
43325|NCT02718547|"     The Investigators propose to examine the effect of lowering the intraocular pressure on     macular edema in Participants diagnosed with diabetic macular edema. Our theory is based on     the assumption that lower intraocular pressure means higher Ocular Perfusion pressure, which     may cause an improvement in retinal perfusion and thus an improvement in retinal oxygenation     and reduced edema   "
43326|NCT02718534|"     This study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy     took place within 48h with therapy took place after 48h for patients with stroke (modified     Rankin Scale Score 3-4).   "
43327|NCT02718521|"     Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive     sufficient hydration before application of contrast to prevent CIN, but hydration could     obviously increase the preload for congestive heart failure (CHF) patients. Isosorbide     Dinitrate could reduce cardiac preload and afterload by expanding vein and artery.so adequate     hydration therapy combined with intravenous infusion of isosorbide dinitrate could better     prevent contrast-induced nephropathy theoretically.This prospective, randomized,     double-blind, comparative clinical trial randomly selected 264 patients with estimated     glomerular filtration rate, (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary     angiography to receive either the convention hydration (n=200) or the hydration therapy     combined with intravenous infusion of isosorbide dinitrate(n=200).   "
43328|NCT02718508|"     The objective of this trial is to test feasibility and acceptability of an e-parenting skills     intervention with parents of injured adolescent alcohol users (12-17 years old) as compared     to standard care at three pediatric trauma centers. To examine these questions, the     investigators will randomly assign adolescent and parent dyads (n=75) to one of two groups.     One group will continue to receive the institutional standard care of a brief alcohol     intervention delivered by clinical staff to the adolescent with no parenting skills     intervention. The second group will continue to receive the same institutional standard care     plus the parent will receive an e-parenting skills intervention consisting of: the online     parent training program, Parenting Wisely(PW), plus text messaging and a web-based message     board. Study participants will be injured adolescents, 12-17 years old, admitted to the     inpatient service of the trauma center, and with a positive CRAFFT (mnemonic acronym of first     letters of key words in the screening tool) screen for alcohol use. Adolescents' alcohol use     will be measured at study enrollment and at 3 and 6 months after discharge. Adolescents'     alcohol related negative consequences will be measured at study enrollment for the 6 months     prior to hospitalization and again at 6 months after hospital discharge. Parenting skills     will also be assessed at 3 and 6 months.   "
43370|NCT02717962|"     The purpose of this phase 2, single arm, biomarker-driven study is to determine if treatment     of O-6-methylguanine-DNA methyltransferase (MGMT) unmethylated recurrent glioblastoma with     VAL-083 improves overall survival (OS), compared to historical control.   "
43329|NCT02718495|"     This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The     first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose     (SAD) treatment group. The second group will enroll adult subjects with CF, including those     on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane     conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group.     Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for     a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will     enroll adult subjects with CF, including those on background treatment with KALYDECO® and     those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts.     Approximately 136 subjects will be enrolled.   "
43330|NCT02718482|"     Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the     Ifosfamide treatment of patients with relapsed osteosarcoma   "
43331|NCT02718469|"     The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the     strength of the immune response.   "
43332|NCT02718456|"     The study will evaluate interventions to improve engagement in HIV care following HIV     diagnosis through a voluntary counseling and testing program. The specific aims are to (1)     determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer     counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on     ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a     third to standard counseling and referral, a third to receive CD4 testing at the VCT with     results return by phone after 1 weeks, and a third to receive the same CD4 testing combined     with peer counseling. These combined investigations will create a comprehensive understanding     of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve     measurable outcomes in applied settings.   "
43333|NCT02718443|"     VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine     safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA     vaccine VXM01   "
43334|NCT02718430|"     Phase I study in patients with metastatic colorectal cancer with liver metastasis under     second or third line therapy to examine safety, efficacy, and immune biomarkers after     treatment with VXM01   "
43335|NCT02718417|"     This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of     avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients     must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian     (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for     platinum-based chemotherapy.      The primary purpose of the study is to demonstrate if avelumab given as single agent in the     maintenance setting following frontline chemotherapy or in combination with     carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by     observation in this population of newly diagnosed ovarian cancer patients.   "
43336|NCT02718404|"     The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve 3 Tesla     MR-HIFU device for treating painful bone metastases.   "
43337|NCT02718391|"     This phase II, randomized, open-label trial aims to assess whether the vaccination increase     RFS in disease free melanoma patients after surgery. Patients will be randomized between     Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or     homogenate (6 vaccines every 4 weeks) and observation.   "
43338|NCT02718378|"     The current study is designed as a phase Ib multiple dose study to evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral     administration for 28 days.   "
43339|NCT02718365|"     The purpose of this study is to evaluate whether the long-term outcome and safety of wedge     resection are comparable to segmentectomy for the surgical treatment of early stage (IA)     non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and     suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected     population of patients with Stage I NSCLC. However, one critical question needs to be     addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al.     reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge     resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the     mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO     nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that     the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive.     Therefore, these lesions are potential candidates for wedge resection. This randomized     clinical trial is to assess whether wedge resection can be established as a standard     treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.   "
43340|NCT02718352|"     Many buprenorphine treatment programs do not have services dedicated to adolescents and young     adults. As a precursor to developing and evaluating an adolescent and young adult     buprenorphine treatment program at APT Foundation Inc, we propose to conduct a 1 year     prospective study of 16 to 25 year old treatment-seeking individuals enrolled in the APT     Adolescent and Young Adult Suboxone Program   "
43341|NCT02718339|"     Prospective randomized clinical trial to assess the effect of in-hospital intensive     counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma.      The study population will include asthma patients admitted to internal Medicine departments     and medical ICU at Soroka University Medical Center, due to asthma exacerbation.   "
43342|NCT02718326|"     The primary objective of the study is to assess the efficacy of intravitreal (IVT)     aflibercept compared to sham treatment in the improvement of moderately severe to severe     nonproliferative diabetic retinopathy (NPDR).   "
43343|NCT02718313|"     The purpose of this study is to investigate the type of the cardiac disease using     transthoracic echocardiography in patients whose preoperative electrocardiography shows the     intraventricular conduction delay.   "
43344|NCT02718300|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of the     combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.   "
43345|NCT02718287|"     This is a cluster-randomized study of a home visiting program targeting mothers of children 0     to 2.5 years of age with the objective of improving global child development. The program,     Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the     poorest Region (V) of the state of Fortaleza, Brazil.   "
43347|NCT02718261|"     Data show that episodes of bleeding may often be observed in critically ill patients with     dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a     clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease (ESRD)     may be considered a high risk population in regard to e.g. development of gastrointestinal     (GI-) bleeding.      In the current prospective subanalysis SIREN of the randomized placebo-controlled clinical     trial SUP-ICU (NCT02467621), the investigators seek to elucidate whether the subpopulation     of critically ill patients with acute kidney injury requiring renal replacement therapy (RRT)     benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.   "
43348|NCT02718248|"     To refine a novel intervention using a combination of a smart phone application with best     practice psychotherapy for men who have presented to hospital with intentional self-harm. The     outcome will be change in baseline of scores on a depression rating scale the PHQ-9 at six     weeks. Moreover, the investigators will ask clinicians and participants about the     acceptability of the intervention and the acceptability of using routine data sources as     outcome measures. This will inform methods of recruitment for the larger cluster randomized     controlled trial and the creation of a treatment manual.   "
43349|NCT02718235|"     With this prospective, multicenter trial the investigators aim to establish the     Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective     study, as a new tool for risk stratification of patients after resection of hepatocellular     carcinoma that can be widely used in the clinical practice. The investigators expect to show     that this score is a prognosticator for overall survival and also disease free survival.     Further, it should be demonstrated that the HCCIS is a risk stratification tool that is     independent from clinical or descriptive parameters. Additionally, the investigators plan to     elucidate that the respective HCCIS risk groups are not only different with respect to     immunological infiltration but are also different with respect to tumor biology. The finding,     that tumors of the respective risk groups show different tumor biology leads to the     assumption that different therapy strategies need to be applied. Therefore, in a     translational approach we aim to build up a data base with HCC tumor organoids and test the     effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS     risk groups.   "
43350|NCT02718222|"     Studying the impact and performance of institutionalizing immediate post-partum IUD services     as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania,     and Nepal.   "
43351|NCT02718209|"     The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together     with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in     real time during surgery.   "
43352|NCT02718196|"     The specific aims of this study are : 1) To pilot test the alpha build prototype of the sleep     training smartphone application using a sample of parents looking for sleep training advice     online. 1a) To assess the efficacy of the application in helping parents with the sleep     training process 1b) To assess the 'workability' of the application 2) Use feedback to guide     the next round of development with the goal of building out the applications functionality     and increasing usability.   "
43353|NCT02718183|"     OBJECTIVES: The aim of this clinical randomized, double-blind clinical study was to assess     the markers levels of RANKL IL-1B and OPGL, involved in the external cervical resorption as a     primary outcome, and change color effectiveness in patients undergoing intracoronary     bleaching.      METHOD: 46 volunteers (50 teeth) participated with discoloration on non-vital teeth, with the     endodontic treatment in good condition. Patients were randomly located into two study groups     according to product G1 = 35% hydrogen peroxide (n = 25) and G2 = 37% carbamide peroxide (n =     25).      The intracameral bleaching was performed with a walking bleaching technique of 4 sessions     Gingivocrevicular transudate samples were taken to determine levels of Il1b, RANKL, and OPGL     with absorbent paper (Periopaper®), they are obtained from six sites per tooth bleaching: 3     vestibular and three palatine (mesial, middle and distal), in 6 opportunities:      Baseline, after 4-sessions of intracameral bleaching and a one week after treatment. Total     proteins are quantified by Bradford ® system and from the eluted sample of RANKL, IL 1b and     OPGL levels measured by ELISA (Quantikine®; R&D Systems Inc.).      The color was evaluated in each session with Vita EasyShade spectrophotometer is used with     the CIEL*a*b system to measure the total variation in color (ΔE), between the baseline and     the different evaluation times.   "
43354|NCT02718170|"     Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation     to plate and screw fixation for unstable extra-articular metacarpal fractures.   "
43355|NCT02718157|"     The primary purpose of this clinical investigation is to verify the performance of the     GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to     the a Culture, a conventional method for detection of Streptococcus agalactiae in     vaginal/rectal swab specimens from antepartum women.   "
43356|NCT02718144|"     This is a multi-center, open-label, phase I/IIa trial, dose-escalation study with a 3 + 3     cohort design to determine the recommended dose of estetrol for the treatment of patients     with advanced breast cancer. After completing phase I part of the study (i.e. 4 weeks of     treatment), patients will receive further treatment for 8 weeks at their individual phase I     dose level (phase IIa part of the study).   "
43357|NCT02718131|"     The current study proposes adding BMP-2 (INFUSE), an anabolic agent, at the surgical site of     TPA repair in children with NF1, compared to a control group of patients treated surgically     without BMP-2. The following Specific Aims will be addressed: 1) to determine if use of an     osteogenic agent (BMP-2) at the time of surgical repair of TPA in NF1 patients will result in     improved bone healing; 2) to document safety of BMP-2 in a pediatric NF1 population; and 3)     to collect, process, and preserve biologic specimens at the time of surgery for future     studies.   "
43391|NCT02717689|"     This study explores if a composite biomarker strategy predicts exacerbation risk in patients     with asthma on high dose inhaled corticosteroid (+/-long-acting beta agonist) treatment and     to evaluate the utility of this composite score to facilitate personalised biomarker specific     titration of corticosteroid therapy in this population.   "
43539|NCT02715752|"     This study measured the changes in health-related complaints by analyzing charts of     individuals, who are infected with a latent virus, who have used Gene-Eden-VIR/Novirin.   "
43358|NCT02718118|"     This study is designed to evaluate the safety, efficacy, and subject and investigator     satisfaction of 2 different injection volumes of Dysport in the glabellar lines.        1. To determine the proportion of composite responders (based on blinded evaluator and          subject assessments) who achieve at least a 1-point reduction from baseline in glabellar          line severity score (GLSS) at maximum frown line on Day 30.        2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.        3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2          visit (subject and blinded evaluator).        4. To assess the subject's satisfaction with the treatment.        5. To evaluate investigator satisfaction of treatment outcome.        6. To evaluate subject psychological well-being.        7. To evaluate subject age appraisal.        8. To evaluate all adverse events during the course of the study.   "
43359|NCT02718105|"     Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per     embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?   "
43360|NCT02718092|"     This is a multi-center, single-blinded, randomized trial comparing AXIOS FCSEMS (Fully     Covered Self Expanding Metal Stent) and plastic stents for EUS (Endoscopic Ultrasound)-guided     management of infected and/or symptomatic WON (Walled Off Necrosis).      Patients will be randomized to either FCSEMS or plastic stents for EUS-guided drainage of WON     in a 1:1 manner. Following EUS-guided drainage patients in both groups will be assessed pre-     procedure, pre -discharge, weeks 1, 6 and months 3, 6, 12 and 24 months. Information will     also be collected from any subsequent hospital admissions related to their walled-off     necrosis.   "
43361|NCT02718079|"     The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to     Jan 2018 at Institute of Liver & Biliary Sciences, New Delhi. Study group will comprise of     patients with acute liver failure (ALF) who have no option for liver transplant (due to any     reason) or have contraindications for liver transplant or have no prospective living donor     and will be assessed for enrollment in the trial.   "
43362|NCT02718066|"     A Phase 1b/2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with     Nivolumab in Patients with Advanced Solid Tumors Including Melanoma, Renal Cell Carcinoma     (RCC) and Non-Small Cell Lung Cancer (NSCLC).      The Primary objective of this study will be:      • To evaluate the safety and tolerability of HBI-8000 when combined with a standard dose and     regimen of nivolumab, to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2     Dose (RP2D) and to evaluate frequency and severity of toxicities of this combination     treatment      Secondary objectives will include:        -  To explore the efficacy of study treatment as measured by Objective Response Rate (ORR),          Disease Control Rate (DCR), Clinical Benefit Rate (CBR), Duration of Response (DoR),          Progression-Free Survival (PFS) in all patients treated at RP2D        -  To obtain pharmacokinetics of twice weekly HBI-8000 when administered in combination          with nivolumab administered once every two weeks        -  To characterize the effect of HBI-8000 on the electrocardiogram QT interval corrected          (QTc) interval.      Dose Escalation Phase (1b) will include up to 18 patients, followed by Cohort Expansion Phase     (2) including up to 20 patients per tumor indication at MTD and/or RP2D.   "
43363|NCT02718053|"     The purpose of the study is to evaluate the reliability of spasticity measurement with     Lokomat   "
43364|NCT02718040|"     This study is designed to        1. evaluate the naturalness of facial expressions in motion (2D video images), by treating          investigator assessment        2. evaluate naturalness of facial expressions (photographs), by treating investigator          assessment        3. evaluate perceived attractiveness and age of subject (2D videos), by treating          investigator assessment        4. evaluate aesthetic improvement, by subject and treating investigator assessments        5. evaluate subject satisfaction        6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment        7. evaluate marionette lines (MLs) severity, by treating investigator assessment        8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis        9. evaluate all adverse events reported during the study.   "
43365|NCT02718027|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Alport     disease from plasma.   "
43366|NCT02718014|"     The present study was evaluated periodontal status in pre and post-menopausal women with     periodontitis following non-surgical therapy.   "
43367|NCT02718001|"     Early feasibility study to evaluate the safety and function of the Edwards Lifesciences     CardiAQ™ Transcatheter Mitral Valve   "
43368|NCT02717988|"     This double-blind, placebo-controlled, single ascending dose study is designed to demonstrate     safety, tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers. The results of     this study will guide selection of dose levels for future multiple dose studies in healthy     volunteers and adult patients with moderately to severely active rheumatoid arthritis.   "
43369|NCT02717975|"     It is estimated that over 10% of men above the age of 60 will experience an episode of     urinary retention over a period of 5 years and will need urethral catheter. Some of these     patients are discharged from the hospital with urethral catheter, for them to attend a Trial     Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after     catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient     get the urge to pass urine and empty the bladder.      The main objective of this study is to see the effect of catheter valve on the length of     clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed.      In this study after randomization, patients in Group A (catheter valve group) will be given a     catheter valve before they are sent home with the catheter.They will be asked to close the     valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250     mls in bladder with natural filling) before their appointment. It is very likely that by the     time these patients are seen in the TWOC clinic their bladder is already full and they will     void soon after removal of catheter.The patients in Group B (control) will go home with free     drainage catheter and urine bag (standard catheter removal). These patients on arrival, in     the TWOC clinic will have an empty bladder when their catheter is removed, they will then     drink plenty of fluids in the clinic and wait for their bladder to be full before they void     spontaneously.      This study will last for one year after approval by ethical committee.      The time saved in this process would lessen patient anxiety, lead to more patients being     reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.   "
43371|NCT02717949|"     There still remains the question if hepatitis C eradication with all oral therapy will lead     to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is that     oral HCV therapy will lead to a high rate of hepatitis C eradication which will correlate     with a reduction of the size and extent of low-grade lymphoma. The hypothesis of this study     is that subjects with hepatitis C,regardless of genotype, who have low grade lymphoma, when     treated for hepatitis C without pegylated interferon will have a regression of low grade     non-Hodgkin's lymphoma. In this pilot study we will evaluate the effect of     Sofosbuvir/ledipasvir or sofosbuvir/ribavirin based antiviral therapy on the course of a     subset of HCV-related low grade B cell non-Hodgkin's lymphoma      Primary Objective This study will assess the safety, as measured by adverse events, in     subjects receiving hepatitis C treatment.      Secondary Objective The secondary objective of this study is to assess the rate of overall     response of B cell non-Hodgkin's lymphoma defined as either as partial response or complete     response according to revised international working group criteria for non-Hodgkin lymphoma.      Primary Endpoint Safety and tolerability of sofosbuvir/ledipasvir or sofosbuvir/ribavirin in     subjects with B-cell non-Hodgkin's lymphoma will be assessed by number of adverse events and     serious adverse events. In addition, the study will assess the number of subjects who had to     stop treatment due to adverse events or serious adverse events. The study will also examine     the number of subjects in which treatment for lymphoma had to be given due to clinical     progression.      Secondary Endpoints The secondary endpoint(s) of this study is to (1) Assess the rate of     overall response of B-cell Non-Hodgkin's lymphoma defined as either as partial response or     complete response according to revised international working group criteria for non-Hodgkin     lymphoma. (2) Determine the rate of sustained viral response in subjects with low-grade     lymphoma.   "
43372|NCT02717936|"     Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool     using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared     to regular H&E staining. The investigators therefore plan to include 73 participants with a     confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.   "
43373|NCT02717923|"     This is a single arm, open-label clinical trial to evaluate the efficacy and safety of     maintenance treatment with capecitabine plus cetuximab after first-line modified     fluorouracil, leucovorin, and oxaliplatin(mFOLFOX6) plus cetuximab for patients with KRAS     wild-type metastatic colorectal cancer.   "
43374|NCT02717910|"     This feasibility study evaluates acceptability and preliminary effectiveness of a digital     health game as an intervention supporting tobacco-related health literacy in 10- to     13-year-old early adolescents. One third of the study participants will receive the health     game, on third a web page with similar content and one third will act as a control group     without intervention.   "
43375|NCT02717897|"     The purpose of this study is to test blood and tissue samples of people with Ulcerative     Colitis (UC) to see what effects vitamin D may have on the immune system. This research is     being done because it could lead to the development of new treatment for people with     inflammatory Bowel Disease (IBD).   "
43376|NCT02717884|"     The objective of the phase I part of the trial is the determination of the maximum tolerated     dose (MTD) of TCP (Tranylcypromine) in combination with fixed-dose ATRA (all-trans-retinoic     acid) and with fixed-dose AraC (Cytarabine) and to derive the recommended phase II dose     (RP2D) in patients with non-APL AML or MDS for whom no standard treatment is available or who     failed azanucleoside treatment.      The objective of the phase II part of the trial is a first evaluation of the efficacy of TCP     at the RP2D in combination with fixed-dose ATRA and with fixed-dose AraC as basis for further     investigations of TCP   "
43377|NCT02717871|"     To assess the safety and efficacy of PACK-CXL (photoactivated chromophore for infectious     keratitis cross-linking) as a firstline treatment for infectious corneal infiltrates and     early corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.   "
43378|NCT02717858|"     This trial is conducted in Europe. The aim of this trial is to investigate the effects of     liraglutide on gallbladder emptying in overweight and obese subjects.   "
43379|NCT02717845|"     Malalignment of the knee joint causes arthritis in later life. Currently there are three     surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and     high tibial osteotomy (HTO). The former two very much focus on treating the effect of     malalignment, i.e. removing the arthritic joint. However, HTO addresses the cause of the     arthritis, namely the joint malalignment. This preserves the patient's joint and it means     that a patient will start using the unaffected part of the knee joint more.      HTO involves cutting a wedge out the tibia to correct the alignment of that bone with the     knee joint, to redistribute load from the affected medial part to lateral part. To keep the     tibia in the new position, a medical nail device is attached to keep it in place and allow     new bone to regenerate within the wedge. Currently, the market leader for HTO is the TomoFix     (by DePuySynthes company) plate and nail device. As the name suggests, TomoFix is fixed at     surgery and therefore the change in bone angle cannot be changed afterwards. It does mean     that patients can be weight-bearing on the affected leg soon after the HTO procedure. A new     CE-marked device is being tested in an interventional trial; it is produced by Ellipse     Technologies. This device is an extendable nail and inserted intramedullary; following     surgery the nail is tend slowly extended over a period of time until the bone correction is     satisfactory.      The CISKO imaging study will assess whether there is a difference between the TomoFix and     Ellipse system in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3     and 6 months post-operatively. This will be quantified by two independent radiological     reports. A secondary objective is to investigate patient satisfaction and also patient pain     levels at these time intervals. The degree of bone healing is usually the main factor holding     clinicians back when it comes to advising patients on what activities they can return to     post-operatively. A difference in bone healing between the two systems may impact on the     advice clinicians can give patients regarding recommencing more intense activities such as     recreational sports, which ultimately could positively impact patients' health and     well-being.   "
43380|NCT02717832|"     The overall goal of this project is to identify factors that protect some obese adults from     becoming insulin resistant. Identifying mechanisms that help protect some obese adults from     developing insulin resistance could lead to novel, targeted therapeutic and/or preventative     strategies for obese adults who are insulin resistant.   "
43381|NCT02717819|"     The purpose of the study is to investigate if an increased protein intake, in the form of a     protein-enriched, milk-based supplement, can enhance the beneficial effect of resistance     training, offered during hospitalization and 12 weeks post discharge, in older patients. This     will in part be evaluated from measures of muscle strength, muscle mass and physical     functioning. Also, the study population's acceptance of the intervention product will be     assessed along with measures related to 'cost-effectiveness'.      A sub-study will be performed in a sub-group (n=30) to investigate if bio-impedance analysis     (BIA) correlates with Dual-Energy X-ray absorptiometry (DXA) at single time points, and to     see if it is possible to track changes in lean body mass. In addition, the reliability of the     bio-impedance analyzer will be evaluated.      Also, the prevalence and classification of sarcopenia will be assessed at baseline, and     correlations to nutritional status will be investigated (n=120).   "
43392|NCT02717676|"     Previous studies concluded that striae gravidarum assessment appears to predict the     occurrence of perineal tears and recommend training the health personnel to calculate the     total striae score which can help them decide if episiotomy is to be given or not. Episiotomy     definitely seems to be preventive for perineal tears but giving episiotomy for the same is     still debatable as episiotomy in itself is associated with morbidity. the hypothesis is     episiotomy done in patients with high score will definitely protects against perineal tears.     So, the aim of study is to determine whether assessment of striae gravidarum score could     predict occurrence of tears during labor or not, and if episiotomy will prevent perineal     tears in women with high score.   "
43382|NCT02717806|"     The PATHway system is designed to help patients remain physically active and maintain a good     cardiovascular health. It proposes a novel approach that aims to empower patients to     self-manage their CVD, set within a collaborative care context with health professionals.     This will be achieved via a patient-centric holistic approach that specifically addresses the     above barriers. It involves an internet-enabled and sensor-based home exercise platform. It     is represented by several modules with an exercise module as the core component which will     provide individualized rehabilitation programs that use regular, socially inclusive exercise     sessions as the basis upon which to provide a personalized, comprehensive lifestyle     intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable     patients to both better understand and deal with their own condition and to lead a healthier     lifestyle in general.      The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle     and health related physical fitness and cost-effectiveness of the PATHway intervention in     patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).   "
43383|NCT02717793|"     1 repetition maximum (RM) and Maximum Voluntary Contraction (MVC) with digital dynamometer     are popular method of measuring muscle strength. The types of muscle contraction involved in     both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with digital     dynamometer involves isometric muscle contraction (IMMC). There are several risks involved in     measurement of 1RM, such as delayed onset muscle soreness (DOMS) and unsafe for pathological     joints etc, this can be reduced if IMMC is used in measuring strength. Though both cannot be     equated as they are different type of contraction, therefore the purpose of this study was to     compare between 1RM measurement and isometric MVC using a digital hand-held dynamometer in     healthy females. Twenty nine young females (mean age = 20.77 ± 1.28) without any weight     training experience (mean BMI = 20.43 ± 1.85) volunteered for the study. It was a crossover     trial where 48 hours of rest period was given between each measurement technique. The result     showed moderate correlations (r = 0.365-0.847) between 1RM and MVC. A simple linear     regression analysis revealed a significant estimated regression equation for dominant and     non-dominant hands. [Dominant, Y=0.391x + 1.472; Non-Dominant, Y=0.251x + 2.629; (Y: 1RM, x:     Isometric)] with low standard error of estimation value of (Dominant, 0.74; Non-dominant,     0.80). The result also showed no significant difference between these derived equations and     Brzycki 1RM prediction equation. Therefore, it was concluded that both prediction equations     can be used interchangeably to predict the strength of a person, and thus IMMC can be used to     predict 1RM in healthy females.   "
43384|NCT02717780|"     The investigators aim to assess the respiratory effect of short half-life agents in balanced     anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea     syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane versus     a regimen of fentanyl-sevoflurane. Each patient will undergo three respiratory portable     polygraphies: the night before the surgery ; the first night following the surgery ; the     third night following the surgery.   "
43385|NCT02717767|"     The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of     white corpuscles is altered during pneumonia. In presence of bacterial growth on lung     samples, the measure of autofluorescence of white corpuscles could help the clinicians to     discriminate bacterial colonization from acute infection.   "
43386|NCT02717754|"     This multi-center, randomized, double-blind, multiple-dose, placebo-controlled,     parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its     carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized to     receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered     intravenously twice daily (BID). The anticipated time on study treatment is 5 days.   "
43387|NCT02717741|"     Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular     Endothelial Growth Factor Receptor (VEGFR).      This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and     preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are     conducting in Cancer Hospital Chinese Academy of Medical Sciences.   "
43388|NCT02717728|"     There is currently no standard of care or best practice for managing post-operative pain for     patients undergoing hip arthroscopy. Perioperative pain with these procedures can be     substantial. It has been shown that up to 90% of patients in the Post-anesthesia care unit     (PACU) following hip arthroscopy report pain scores of 7/10. Poor pain management following     hip fracture surgery directly results in increased time spent in high cost health care areas     and delayed time to ambulation. Continuous regional anesthesia following hip arthroplasty has     been shown to reduce narcotic consumption and related side-effects (reduction of     post-operative pain, delirium, and length of stay).      The purpose of this research is to evaluate the effectiveness of a fascia iliaca nerve block     in reducing post-operative pain within the first 24 hours following hip arthroscopy.     Additionally, the pharmacokinetics of the drug ropivacaine will be studied via laboratory     analysis of blood samples. Ultimately, the objective of this research is to develop a     standard of care or best practice for the management of post-operative pain following hip     arthroscopy. This study will include the entire age range of patients who are seen for hip     arthroscopy at Boston Children's Hospital, for which there is a 35 year age limit. Both sexes     will be included in the study.      The study design will be real catheter versus a sham catheter(control). All subjects will     receive general anesthesia. The catheters (real or sham) will be administered after the     induction of general anesthesia and before the beginning of the surgery until 24 hours after     recorded PACU admittance time. The anesthesia team placing the block will not be blinded. The     orthopaedic surgeon (Dr. Yen) and all evaluators will be blinded to the absence or presence     of a real catheter. In the case of a sham catheter, the anesthesia team will rig a pump to     look like it is dispensing local anesthesia.      To determine the pharmacokinetics of ropivicaine during standard fascia iliaca block,     following induction of general anesthesia, a large bore IV catheter will be inserted for the     purpose of blood draws (all patients).   "
43389|NCT02717715|"     This study aims to determine the effect of a supervised home-based physical fitness program     on the aerobic capacity, quality of gait and health related quality of life in people with     chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term     lifestyle change will be investigated.   "
43390|NCT02717702|"     Acute Coronary Syndrome (ACS) is a serious heart condition that is a leading cause of death     in America. Cardiac stress testing is currently the best test to non-invasively identify     which patients might be having ACS and may need more invasive testing such as a cardiac     catheterization (placing a tube in the heart) for coronary angiogram (invasive mapping of the     blood vessels of the heart). However, stress tests require imaging by highly trained     specialists and even then may not correctly categorize a small minority of patients being     evaluated for ACS.      Advances in blood tests may now allow detection of the very early stages of heart blood     vessel blockage via a simple blood test. The investigators seek to determine whether these     blood tests can help to better identify patients with ACS. The study will also store any     extra blood sample that may be left over for future use.   "
43393|NCT02717663|"     The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions     and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm     randomized factorial trial to increase MVPA adoption and maintenance among inactive adults.     Using neighborhood walkability and socioeconomic status, participants will be recruited from     four neighborhood types: high walkable/high SES, high walkable/low SES, low     walkable/high SES, and low walkable/low SES. We will evaluate synergistic or antagonistic     effects of interventions and neighborhood factors on MVPA adoption by 12 months and     maintenance by 24 months.   "
43394|NCT02717650|"     Exercise testing has become clinically important in the management and ongoing evaluation of     patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation     previously linked to lower mortality risk (1).      Lower exercise capacity generally correlates with more severe lung disease (2,3) and landmark     studies suggest that low exercise capacity as measured by peak oxygen capacity (VO2peak) and     rate of decline in lung function (FEV1) are strong predictors of mortality (1,4). However not     all studies have found pulmonary function tests (PFTs) to be reliable predictors of maximal     exercise capacity (5), especially in relatively well preserved lung function (6,7).      The wide distribution in physical capacity between fit individuals and end stage disease adds     to complexity of assessment. Independent factors of age, genetics, habitual exercise,     nutritional status and musculoskeletal conditions are all known to influence physical     capacity in patients with CF (8,9).      Maximal exercise testing places additional stress on cardiovascular, respiratory and     peripheral systems providing more information around multiple influences on disease     progression including degree of limitation in these major systems (10,11) and is useful for     assessment of exercise desaturation, more common (but not always present) in advanced lung     disease (5,12).      With prediction of exercise performance and functional capacity from PFTs unreliable and the     understanding that health status correlates better with exercise tolerance there has been an     increase in maximal exercise testing for patient management (13). Many international centers     now regard exercise testing as highly important with many assessing maximal exercise capacity     annually to monitor disease progression, identify physical status and drive changes in     medical, physiotherapy or nutritional management (14,15).      The main vision is to develop a standardized incremental step test protocol suitable for     adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in     line with current exercise testing recommendations (15). To develop a more useful field test     to assess exercise tolerance and a more user friendly test than the currently available     laboratory exercise test to allow for early detection of decline in physical function in the     day-to-day clinical setting. To date no studies have been published in adults with CF where     an incremental exercise step test has been investigated to assess exercise tolerance or     determine maximum oxygen uptake (VO2max).   "
43395|NCT02717637|"     All patients undergoing an elective caesarean section under spinal anesthesia will, according     to the hospital routines, receive 10 mg oxycodone slow-release tablet when arriving at our     postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1 hour, 2 and 6 hours     after administration in order to investigate bioavailability.   "
43396|NCT02717624|"     To characterize the safety profile of acalabrutinib in combination with bendamustine and     rituximab in subjects with treatment naive and relapse/refractory Mantle Cell Lymphoma (MCL)   "
43397|NCT02717611|"     A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects     with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy   "
43399|NCT02717585|"     Fibromyalgia (FM) is a chronic pain disorder associated with a wide spectrum of sleep     disorders. In fact, insomnia and waking unrefreshed are currently considered part of the     criteria for diagnosis. Recent studies show that sleep quality and symptoms of FM are     inversely correlated. Obstructive sleep apnea (OSA) is a sleep disorder characterized by     repeated episodes of complete or partial blockage of the upper airway. Nonrestorative sleep     and fatigue are common symptoms of FM and OSA and may suggest related pathophysiology or     co-morbidity that is yet to be diagnosed. This prospective randomized controlled clinical     trial will enroll adult FM patients who screen positive for OSA by the STOP-Bang     questionnaire. OSA will be confirmed by a laboratory polysomnography (PSG) study. After     undergoing further baseline questionnaires and investigations, patients confirmed to have FM     with moderate to severe OSA will be randomized to one of two different treatments: 1)     Treatment for FM at the Chronic Pain Clinic together with Continuous Positive Airway Pressure     (CPAP) devices for their OSA OR 2) Control group receiving treatment for FM at the Chronic     Pain Clinic only.   "
43400|NCT02717572|"     In the current study, the investigators plan to expand the knowledge of Positron Emission     Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of     fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent     diffusion coefficients (ADC) measurements, in a broad population of patients with malignant     solid tumors.   "
43401|NCT02717559|"     In this study the investigators will examine patients who have undergone unilateral ACL     reconstruction surgery to determine which structural and functional characteristics of the     knee two and ten years post reconstruction surgery, aspects of the original injury and     repair, and patient characteristics are risk factors for osteoarthritis after ACL     reconstruction surgery.   "
43402|NCT02717546|"     The objective of this observational prospective study is to systematically document the     clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied     to distal tibia fracture treatment and confirm safety and performance of the screws.   "
43434|NCT02717130|"     An Open-label, Multi-center, Longitudinal, Within-subject Comparison Study to Evaluate the     Effects of Aripiprazole Once Monthly in Subjects with Schizophrenia on 30-, 90-, and 180- day     Re-hospitalization Rates Following Hospital Discharge Compared with Retrospective     Re-hospitalization Rates while on Oral Antipsychotic Medication.   "
43540|NCT02715739|"     This study aims to compare the predictive performance of two different approaches of the     international classification of disease injury severity score (ICISS) using data from four     public university hospitals in urban India.   "
43403|NCT02717533|"     The objective of the proposed study is to demonstrate that serial blood volume analysis (BVA)     using RI-BVA (BVA-100, Daxor, NY) can be used to guide changes in prescription of dry weight     for hemodialysis patients. The knowledge of a patient's ideal BV and degree of hypervolemia     using these measurements can be used to change the prescription of DW in an objective way     instead of the current standard of practice, which is based on subjective prescription of dry     weight. A first study was conducted to determine the rate of plasma volume (PV) re-expansion     for each patient as a guide to rate of fluid removal (results published, refer to citations).     A second study was conducted in order to assess the value of a BVA measurement in guiding     prescription of clinical DW. A follow up BVA would then be done in order to check if patients     were closer to ideal BV than prior to changing dry weight.   "
43500|NCT02716272|"     The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s)     would delay tumor progression in patients with unresectable MPM, experiencing disease     progression after one or two lines of chemotherapy including at least first-line with     pemetrexed and platinum, without altering significantly the quality of life of patients.   "
43404|NCT02717520|"     The primary objective of this study is to evaluate long-term clinical performance of a glass     hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five     years. The secondary objective is to evaluate the suitability of intraoral impressions for     the assessment of wear of teeth and restorative materials over five years. For that purpose     the replica method and scanning 3-D laser equipment and matching software will be used.      The first null hypothesis is that there would be no difference in clinical performance     between restorative materials after five years. The second null hypothesis is that wear     between the restorative materials will be the same after five years.      This is a multicentre, controlled clinical study conducted in Croatia, Italy, Turkey and     Serbia. Eligible participants are all adults aged 18 or over with indication of restorative     treatment on vital teeth in posterior molar region, limited to two surface in a healthy     subjects. Exclusion criteria are presence of full dentures or crowns and bridges in occlusal     contact with teeth indicated for restorative treatment, severe bruxing and unstable     physiological or medical health, pregnancy and lactation, radiation therapy or using drugs.     Each patient is receiving two restorative treatment (GIC-EQUIA Forte and composite resin     material Tetric EvoCeram) each of which will be localized on molar teeth on either side of     the mouth. Two independent examiners will evaluate the restorations at each site one week     after placement and at one, two, three, four and five years according to the FDI criteria.     After, three and five years recall, impressions of both restorations is taken and the casts     is analysed by a 3D laser scanner.   "
43405|NCT02717507|"     This randomized phase IIb trial studies how well low-dose carvedilol works in preventing     heart failure in cancer survivors exposed to high dose anthracyclines for management of     childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much     greater risk for developing heart failure compared to survivors who didn't get any     anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and     can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular     complications.   "
43406|NCT02717494|"     The purpose of this study is to determine the safety, reactogenicity, immunogenicity,     transplacental antibody transfer and interference with infant responses to childhood     vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10) or     pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.   "
43407|NCT02717481|"     Examine a new method based on fusion between ultrasound (US) and previous     ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm     and measure the changes over time and following invasive repair procedure.   "
43408|NCT02717468|"     In high-risk patients, it is now recommended to guide the intraoperative volume replacement     via the stroke volume.      Today, the most commonly used technique for estimating the stroke volume is the arterial     waveform analysis in the radial artery. This technique has the disadvantage of being invasive     and increasing the time dedicated to anesthesia during the surgery.      The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has     developed a continuous monitoring technology and non-invasive arterial pressure, cardiac     output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of     blood pressure by this technique was validated in cardiothoracic surgery but studies about     monitoring cardiac output or stroke volume are inconclusive and contradictory.      The objective of this study is to compare the use of non-invasive monitoring of stroke volume     by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in     major surgery.   "
43409|NCT02717455|"     This phase I trial studies the side effects and best dose of panobinostat in treating younger     patients with diffuse intrinsic pontine glioma that is growing, spreading, or getting worse     (progressive). Panobinostat may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
43410|NCT02717442|"     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of     Meniere's disease.   "
43411|NCT02717429|"     The investigators propose to conduct a randomized feasibility study of mindfulness meditation     training (MMT) relative to an active cognitive training control group and waitlist control     group in improving emotional regulation in individuals with MS. Individuals will complete     pre- and post-assessments of emotional functioning through a week of daily diary entries, as     well as self-report measures and a behavioral paradigm. Additionally, all participants will     complete an evaluation of neuropsychological functioning, before and after intervention.   "
43412|NCT02717416|"     Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital     admission, and has significant associated morbidity and mortality, especially in the elderly.     The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds     settle with conservative measures, endoscopic therapy is the established method for treating     those bleeds for which this is not sufficient. Despite advances and increased expertise in     managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained     unchanged for several years.      EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper     gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in     non-variceal upper gastrointestinal bleeding. This is a multicenter, prospective, randomized     study.   "
43509|NCT02716142|"     the aim of the study is To compare the effectiveness of rectally administered prostaglandin     E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered     misoprostol before myomectomy to decrease blood loss during and after the operation.   "
43448|NCT02716948|"     This phase I pilot trial studies the side effects of stereotactic radiosurgery and nivolumab     in treating patients with newly diagnosed melanoma that has spread to the brain or spine.     Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high     dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal     antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and     spread. Giving stereotactic radiosurgery together with nivolumab may be a better treatment     for melanoma.   "
43449|NCT02716935|"     The purpose of this study is to assess the effect of a mixture of prebiotics included in a     food supplement on microbiota diversity and functionality, and to explore its subsequent     effects on linear growth velocity and morbidity.   "
43413|NCT02717403|"     Objectives:      The overall goal of this study is to use the principles of chronic disease management to     develop and test an online social networking intervention using the FB platform in a     randomized controlled trial. Our specific objectives are as follows:      Aim 1: To develop and establish an independent closed community in FB for patients with     rheumatoid arthritis, providing an educational platform for disease self-management and the     potential for engaging in social networking with peers (Phase 2).      Objective 1. To beta test the features and navigation buttons and panels in the newly     developed website and FB group.      Objective 2. To evaluate the contents, ease of use and satisfaction with the newly developed     website and FB group by patient advocates (consultants to the study) who participate as     members of the Facebook community.      Aim 2: To evaluate the efficacy of the FB community intervention combined with an educational     website to improve patients' self-management (including knowledge, which is the primary     outcome), decision making and patient-reported outcomes compared with the educational website     alone (Phase 3). We hypothesize that participation in an online closed community offering     evidence-based information combined with peer interaction and support will improve patients'     knowledge.   "
43414|NCT02717390|"     The Investigators propose to conduct a pragmatic randomized controlled trial of 350 one to     four year old children and their caregivers to study the effectiveness of 1) the Bright By     Three (BB3) intervention for promoting children's language and socio-emotional development     and 2) a modified version of the Safe 'N Sound (SNS) intervention for reducing safety hazards     and injuries. The SNS intervention will serve as a control for the BB3 group and vice versa     so that all study participants will receive a clinically meaningful intervention. In     collaboration with primary care clinics that serve low-income and minority children, the     Investigators will recruit and randomize 350 twelve to fifteen month olds and their     parents/caregivers to one of the two intervention arms and deliver the interventions over a 2     year period.   "
43415|NCT02717377|"     This study is designed to test the effects of six 5 minute microbursts of physical activity     spread across the day as compared to either a sedentary control condition or a single 30     minute bout of moderate intensity physical activity on cognitive function, self-reported     energy levels, aspects of eating behavior and measures of metabolic health. The primary     hypotheses are:        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase          afternoon cognitive function as compared to a no exercise condition.        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase          afternoon cognitive function more than a single 30 minute AM bout.      Secondary exploratory hypotheses include        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase          self-reported energy levels, reduce orexigenic appetitive measures and improve measures          of metabolic health as compared to a no exercise condition.        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase          self-reported energy levels, reduce orexigenic appetitive measures and improve measures          of metabolic health more than a single 30 minute AM bout.   "
43416|NCT02717364|"     This study is a local, prospective, non-interventional, non-controlled, multicenter,     observational study (regulatory postmarketing surveillance). Each physician will enroll     patients who have received at least 1 dose of Yervoy, and each patient will be followed for     up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy     use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile     of Yervoy under routine, daily practice   "
43417|NCT02717351|"     To evaluate the Sun Protection Factor efficacy on human skin.   "
43418|NCT02717338|"     The purpose of this study is to determine whether enhancing blood donor competence, autonomy,     and/or relatedness increases intrinsic motivation to donate and improves donor retention.   "
43419|NCT02717325|"     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.   "
43420|NCT02717312|"     The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS     is millions every year. CS is one of the most frequently performed operation for women. As a     consequence many women have a scar in their uterus. Cesarean scar may be associated with     complications in later pregnancies. In recent years there have also been a few reports     indicating that cesarean scar could potentially be associated with menstrual disorders and     infertility. The impact of cesarean scar defect on long term welfare or quality of life is     not clear.      In some women with a history of CS it is possible to recognise a defect in the site of     previous uterotomy years after the performed CS by sonographic examination. This defect in     the scar, also called as a niche, is a consequence of incomplete healing of the scar in the     lower part of uterus. To date there is uncertainty relating to the factors that lead to poor     healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later     pregnancies are not properly known.      The purpose of this study is to investigate the prevalence and the risk factors of cesarean     scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility,     further deliveries and quality of life will be investigated.      This study is a prospective observational cohort study. Women at the age of 18-45 years who     will give birth by elective or emergency CS will be asked to participate. Women are recruited     within two days of CS. Women with known uterus anomaly or von Willebrand disease will be     excluded.      The prevalence of scar defect will be evaluated by transvaginal sonography and     contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and     3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after     the CS.      The following definition for CS scar defect will be used: myometrial discontinuity with a     depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical     cavity as seen on transvaginal sonography with or without saline infusion.      The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects     will be asked to report the number of menstrual bleeding days once a month during 3     consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the     end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to     menstruation.   "
43421|NCT02717299|"     The purpose of this study is to compare the patient reported outcome measures of total knee     replacement patients who received intra operative sensor guided technique for soft tissue     balancing to a group of patients who receive surgeon guided soft tissue balancing.   "
43422|NCT02717286|"     The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a     challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to     evaluate the clinical survival of direct composite resin restorations in first permanent     molars (FPMs) that are affected by MIH, comparing two adhesive systems.   "
43423|NCT02717273|"     This study will be to prospectively determine differences in Surgical Site Infection (SSI) if     a prolonged course of post-operative antibiotics are used following liver transplantation.   "
43510|NCT02716129|"     The primary endpoint of this study is to investigate the effect of adding nalbuphine to     intrathecal morphine on quality of postoperative analgesia and Morphine related side effects     post- cesarean delivery.   "
44016|NCT02709538|"     To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS     formulations for the treatment of perennial allergic rhinitis (patients 12 years of age and     older)   "
43424|NCT02717260|"     Inhibition control deficits is a major risk factor in the transition to the act in suicidal     patients. Neuroimaging studies have shown that this failure was associated with hypoactivity     in the prefrontal cortex (PFC), a brain area involved in the control of impulsivity. It was     recently shown that a noninvasive brain stimulation session applied on the PFC reduces     transiently impulsivity in healthy volunteers. Noninvasive brain stimulation modulates the     activity and connectivity of neural network connected to the stimulation site. The     investigators assume that a repetition of noninvasive brain stimulation sessions on the PFC     will allow a more intense and longer lasting effect on impulsivity and cognitive control in     healthy volunteers compared to a single session and to placebo stimulation. The investigators     assume that this behavioral change will be accompanied by a change in brain activity measured     by resting EEG for the patients in the active group. A more intense and longer lasting effect     is an essential step to transfer these results to patient populations.      The main objective is to study the effect of bilateral stimulation of the PFC by transcranial     random noise stimulation (tRNS) on the inhibition control measured by the cognitive motor     inhibition capacity (Go NoGo test). The secondary objectives are to study the effect of tRNS     on verbal inhibition (measured with the Hayling test); on anxiety (measured with the     State-trait anxiety inventory (STAI)),on angry (measured with the State-trait anger     expression inventory (STAXI)) on verbal and nonverbal inhibition (measured by the Stroop     test), on impulsive behavior (measured by the Barrat impulsiveness scale (BIS 10)) and on the     neuronal electrical activity measured by EEG.   "
43425|NCT02717247|"     Obesity is worldwide a public health problem. According to World Health Organization (WHO),     overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults     die each year. Food addiction is one of the causes of obesity that may benefit from new     therapeutic options.   "
43426|NCT02717234|"     To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood     marker of nutritional intake   "
43427|NCT02717221|"     The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive and     repeatable detecting EGFR-activating mutational status.   "
43428|NCT02717208|"     To evaluate the safety, local tolerability and pharmacokinetic characteristics after     administration of eye-drop HL036 in healthy Korean male volunteers   "
43429|NCT02717195|"     To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in     patients with treatment-resistant schizophrenia (TRS)   "
43430|NCT02717182|"     Interest in patient therapeutic education (PTE) is increasing: in France PTE was included     within the 2009 Hospital, Patient, Health and Territory law as an essential component of     the patient healthcare pathway.      PTE is a complex intervention: its delivery is variable and may vary according to its     content, functioning, providers, targeted patients, environment and even its objectives.     These differences impact the expected results and make difficult the evaluation of PTE     interventions. To overcome this difficulty, it is essential to describe precisely the     intervention, the processes and the implementation of PTE that are usually not known. PTE     interventions need today a global understanding of their mechanisms constituting their     complexity.      CONCErTo study aims at developing a classification of the different elements composing a PTE     intervention that can impact their results and can ensure their continued existence.      Mechanisms implemented during PTE interventions will be analyzed by a qualitative research.     The investigators wish to identify organizational, pedagogical, psychosocial, medical or     contextual elements that can impact the results, the patients' participation and the     continuity of the program.      The perspective of this research is to improve the understanding of PTE by providing thorough     description of the interventions. This work will help stakeholders to better interpret the     results of their interventions, to improve the transferability, the implementation and     finally to determine which are the elements able to improve patients' health status.   "
43431|NCT02717169|"     Background: The interactions between human beings and wearable technology like activity     trackers equipped with biometric sensors can be linked to health related new learning     concepts/instructional methods supporting deep knowledge acquisition, situated,     self-regulated and active learning. This personalized, long term interactions where specific     information is pushed to the learner contributes to deepen the personal understanding related     to the concept of and knowledge about health and has an impact on long term health action     process.      Design and methods: In order to understand the behavioural change process, a multiple case     study including 35 higher education students in Hong Kong from an undergraduate course, BSc     Exercise and Health is currently conducted. Each student uses a wearable device (activity     tracker) over a period of five months, reflects weekly on emerging personal data, documents     their thinking and action in the ePortfolio, and engages in an online forum. The participants     enter their experiences with the biometric data, lifestyle adaptations (e.g. more steps),     special situations (e.g. hike, heart rate changes during activity) and how these experiences     lead to specific searches and actions on the web and/or in their real social network. The     ePortfolio will allow the students to critically reflect on their progress and for the     researchers to intervene at any time on the issues related to the participants' postings.     EHealth literacy is used as indicator for the health action process of the participants.     Evidence regarding change in eHealth at the beginning and end of the intervention will be     collected with a standard questionnaire detecting eHealth their literacy scale.      Scope: By reflecting on the information from their personal activity tracker and documenting     it in their own ePortfolio, the students will continuously learn to analyse, search and     critically assess health related personal and available digital information, organize it,     present and discuss it with peers/tutor. This in turn will enhance critical thinking, raise     questions about health related topics, stimulate further inquiry deepen their knowledge about     personal health, inducing a healthier lifestyle.   "
43432|NCT02717156|"     This phase II trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab     work in treating patients with urothelial (bladder) cancer that has spread from the primary     site to other places in the body or has come back and does not respond to certain     chemotherapy drugs. Combinations of biological substances in recombinant EphB4-HSA fusion     protein may be able to carry tumor-killing substances directly to urothelial cancer cells.     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells     to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab together     may be a better treatment for patients with urothelial cancer.   "
43433|NCT02717143|"     Acute myocarditis is a serious illness affecting a young population with a very variable     course (of full recovery at the onset of dilated cardiomyopathy (DCM), or even sudden death).     Very few studies have examined the predictors of death and serious cardiovascular events in     acute myocarditis and have carried on numbers of restricted patients. What little data     results in a lack of a precise recommendation on the management and the follow-up period of     patients.      This observational study should identify serious prognostic factor for cardiovascular events     in order to provide a support strategy and more appropriate monitoring of myocarditis.   "
43435|NCT02717117|"     Crohn's disease (CD) is becoming more common. One of the main features of this disease is     weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems     have a strong negative effect on the patients' quality of life but the causes of these     problems are not well understood.      Enteroendocrine cells are nutrient sensors in the bowel that secrete special chemicals     (called hormones) that control appetite and the movements all the gut. The investigators     think that this control mechanism goes wrong in Crohn's patients and they have set off to do     more research on this. Looking at the inside work of the gut has always been difficult and at     times unpleasant for patients, however recent developments in magnetic resonance imaging     (MRI) are allowing the investigators to study the workings of the gut in greater detail and     without discomfort for the patients.      Before studying the Crohn's patients it is necessary to run a set of pilot experiments in     healthy volunteers using a test meal and subsequent MRI imaging to look at the motion of the     gut. This validation stage of the methodology is essential before embarking in more detailed     studies in the patients.   "
43436|NCT02717104|"     The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug     Coated Balloon Catheter in a heterogeneous patient population in real world clinical     practice.   "
43437|NCT02717091|"     The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and     nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.   "
43438|NCT02717078|"     This study will investigate the use of a low biologically available and high protein diet     (LoBAG) for treatment of type 2 diabetes mellitus. Subjects with type 2 diabetes will be     recruited and asked to adhere to this diet or a control diet for 12 weeks. Food preparation     will be done by subjects at home, following instruction from the study team including a     dietitian. The study will test the hypothesis that the LoBAG diet will lead to a greater     reduction in hemoglobin A1c (HgbA1c) than a control diet over 12 weeks of intervention.   "
43439|NCT02717065|"     Characterizing the nature and severity of tinnitus in individuals presents a particular     challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the     effect on quality of life. Different methods are used to measure each parameter. Loudness is     measured using a technique called minimum masking, in which the subject is presented with a     broadband white noise and asked to adjust the loudness level until they can no longer hear     their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the     Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These     questionnaires assess the perceived severity of the tinnitus and the effect on everyday     activities and quality of life. A visual analog scale (a scale from 0-10) is used as a     general subjective measurement of tinnitus severity. In the first part of this study, we will     measure each of these parameters over a series of sessions to establish a baseline     variability for each individual.      The second part will look at the influence of context-specific visual information on auditory     perception. This involves watching silent videos of a person speaking, with and without an     additional tone designed to match the subject's tinnitus. The effect of this audiovisual     feedback on the subject's perception of tinnitus will be assessed using a subjective rating     scale and the minimum masking task.   "
43440|NCT02717052|"     The study at hand is the first to investigate ketamine's SERT binding in humans, by utilizing     the highly selective SERT radioligand [11C]DASB and positron emission tomography.   "
43441|NCT02717039|"     The purpose of this research is to identify genomic markers that can predict heparin-induced     thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly     used to prevent blood clots and the investigators may be able to identify genomic markers     which can be used to prevent heparin use in people who will get HIT.   "
43442|NCT02717026|"     Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal     vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial.     Different imaging modalities might provide divergent results. Thus, quantification of such     differences is valuable.      The present study aims to reveal and quantify differences in vessel morphology between fundus     photography, fundus angiography, and optical coherence tomography in health and disease.   "
43443|NCT02717013|"     This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB)     on body composition and strength changes during weight loss. When overweight and obese     persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone     mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and     strength, and it is thought that HMB may also preserve muscle, bone, and strength during     weight-loss.   "
43444|NCT02717000|"     Rationale:      Non-alcoholic fatty liver disease (NAFLD) is the most widespread liver disorder in Western     society (prevalence 20-30%). It is strongly associated with overweight and obesity. The     majority of patients have simple steatosis. However, in about 15-30% of the subjects, a     chronic inflammatory state develops that is referred to as non-alcoholic steatohepatitis     (NASH), which leads to an overall increase in morbidity and mortality due to the progression     to fibrosis, cirrhosis and in some cases, hepatocellular carcinoma (HCC). The term NAFLD     comprises both simple steatosis and NASH. Most patients with NAFLD have no or few, mainly     aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH     and in the end, liver-related morbidity and mortality.      To date, liver biopsy is the most sensitive test for detecting and staging NAFLD, and is the     only reliable method for differentiating between NASH and simple steatosis. However, the     procedure of obtaining a liver biopsy is invasive and associated with patient discomfort,     significant complications and high costs. In addition, liver biopsy is prone to sampling     error and inter- and intra-observer variability, due to the small size of liver biopsy     samples. This method is therefore not suitable for screening large numbers of subjects at     risk, or for follow-up of patients with NASH over time. Hence, only subjects at high risk     (usually based upon elevated aminotransferase levels, which is not specific for the presence     of NASH) are biopsied, leading to an underestimation of NASH prevalence and undertreatment.     Further insight into disease mechanisms and risk factors for NAFLD and in particular NASH is     warranted, to enable early diagnosis, adequate therapy and preventive measures to improve     health status of these individuals. Accurate and less invasive methods to evaluate NASH, and     NAFLD, are urgently needed.      Objective: The primary objective of this study is to establish non-invasive tools (e.g.     biomarkers and imaging) to accurately diagnose patients with NASH. The secondary objective is     to show an association between the levels of identified markers and disease severity.      Study design:      Eligible subjects will be included via the outpatient clinics Zuyderland in Heerlen, the     Catharina hospital in Eindhoven and MUMC+ in Maastricht. A subset of eligible subjects has     undergone a liver biopsy for clinical reasons. It is estimated that about 85% of subjects     will be asked to undergo a biopsy for study purposes only. Liver biopsies for study purposes     will be performed during a surgical procedure, e.g. bariatric surgery or cholecystectomy.      Blood, faeces and exhaled air will be collected and a FibroScan (+CAP) will be performed     during a study visit. An MRI will be performed, to estimate the degree of steatosis.     Furthermore, anthropometric data (weight, height, abdominal and waist circumference and blood     pressure (BP)) will be collected.      The participants in the group undergoing liver biopsy during bariatric surgery will be asked     permission to be approached for follow-up measurements 3 months post-surgery. As they will     lose weight, which is associated with improvement of hepatic steatosis, this enables     assessment of possible changes over time. A routine follow-up visit post-surgery will take     place after 3 months. The follow-up measurements will be combined with this visit, minimizing     the burden for the participant. The measurements will consist of blood, faeces and exhaled     air collection and a FibroScan (+CAP) will be performed during a study visit. Furthermore,     weight, height, BP and abdominal and waist circumference will be measured.      Study population:      Subjects with proven NAFLD by histology or NAFLD proven by imaging, who are undergoing     surgery (i.e. bariatric surgery or cholecystectomy) will be asked to participate in this     study. Furthermore, all subjects have to be between 18 and 65 years old.      Main study parameters/endpoints:      Non-invasive tool based on biomarkers and imaging to diagnose NASH.   "
43445|NCT02716987|"     The purpose of this study is to determine the relationship between TAK-831 plasma exposure     and the extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following     single oral dosing of TAK-831 in healthy participants.   "
43446|NCT02716974|"     To assess the safety of treating men with oligometastatic prostate cancer with the following     therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant     androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control     with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic     radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen     deprivation. Androgen blockade will be the same throughout the course of treatment.   "
43447|NCT02716961|"     It is still a challenge for urologic surgeon to prevent the post transurethral resection of     bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor.     Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which     contains mainstream GC treatment scheme. It is common to observe clinically moderate-high     risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can     eliminate remained tumor cells especially those from mucosa basal cells so as to improve the     prognosis of patients. Our clinical trial aims to investigate whether the utilization of     combination of GC treatment scheme and epirubicin instillation would decrease the recurrence     of moderate-high risk NMIBC.   "
44017|NCT02709525|"     The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in     human dental sockets.   "
43462|NCT02716766|"     The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX)     regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.   "
43450|NCT02716922|"     Preterm birth remains the most common cause of perinatal morbidity and mortality. A short     cervi- cal length on transvaginal ultrasonography has been shown to be one of the best     predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical     cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without     prior PTB. However maybe the meta-analysis did not reach the statistical significance due to     the small sample size   "
43451|NCT02716909|"     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many     countries, including the United States. In singleton gestations a short cervical length (CL)     on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.      The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of     cervical pessary has been assessed in several populations including singletons with short CL,     unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical     trials (RCTs) have been published, and several are ongoing. However, no consensus on the use     of cervical pessary in pregnancy or guidelines for management have been assessed.   "
43452|NCT02716896|"     Currently the standard treatment of muscle invasive bladder cancer is the complete removal of     bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught with     complications and risk of death. The researchers hope to learn if chemoradiation (i.e. using     chemotherapy and radiation), also an acceptable treatment for muscle invasive bladder cancer,     can be used a good alternative therapy option.   "
43453|NCT02716883|"     In this study Investigators are going to do early amniotic membrane transplantation (AMT) for     bacterial keratitis.   "
43454|NCT02716870|"     Fructose-containing sugars have been implicated in the epidemics of obesity, diabetes and     related cardiometabolic disorders. This view is supported by lower quality evidence from     ecological observations, animal models, and select human trials. Higher level evidence from     controlled trials and prospective cohort studies have been inconclusive. Whether sugars     contribute to cardiometabolic complications independent of their calories remains unclear. To     address the uncertainties, the investigators propose to conduct a series of systematic     reviews and meta-analyses of the totality of the evidence from controlled trials to     distinguish the contribution of fructose-containing sugars from that of energy in the     development of markers of cardiometabolic risk. The findings generated by this proposed     knowledge synthesis will help improve the health of consumers through informing     evidence-based guidelines and improving health outcomes by educating healthcare providers and     patients, stimulating industry innovation, and guiding future research design.   "
43455|NCT02716857|"     The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily     (BID) in patients with moderate-to-severe chronic low back pain   "
43456|NCT02716844|"     Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain,     functional status and quality of life of the patients diagnosed with osteoporosis.      Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group patients     joined exercise program regularly that was held 3 times a week, 1 hour a day, during 6 weeks     with physiotherapist. Control group patients continued their normal daily lives without any     exercise. After 7 patients quit the study for various reasons, 40 women with primary     osteoporosis (control group n=20, exercise group n= 20), completed the study and were     assessed at the beginning and at the end of 6 weeks. As assesment' measurements Tampa     Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill), Pain     Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed Up-     Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back Scratch     Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis (QUALEFFO-41),     Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale (SLS) and Health     Assesment Questionnaire (HAQ) were performed.   "
43457|NCT02716831|"     The purpose of the study is to test a novel, acceptance-based behavioral treatment for     bulimia nervosa (BN) in adults. This treatment is a type of individual psychotherapy called     Nutritional Counseling And Acceptance-Based Therapy (N-CAAT) that enhances existing cognitive     behavioral therapy (CBT) for BN by incorporating acceptance-based behavioral strategies and     nutritional counseling to help patients eliminate BN symptoms.   "
43458|NCT02716818|"     This study is a parallel arm, randomised, open-label study, including dose titration and     admissions for four overnight stays for 24-hour endocrine profiles. It will compare the     efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement     therapy in the treatment of congenital adrenal hyperplasia (CAH) over a treatment period of 6     months. Dose titration decisions in both treatment groups will be made by a central     independent physician, blinded to the treatment arm, using information generated from the     24-hour endocrine profiles. Each treatment arm will be subject to the same titration rules     throughout the study, ensuring that opportunities for optimisation and control of androgens     are the same in both groups.   "
43459|NCT02716805|"     This is an open-label, multicenter, Phase 1 study of checkpoint therapy, tremelimumab and     durvalumab, administered to subjects with multiple myeloma who are at high risk for relapse.     Checkpoint therapy will be administered prior to and for 2 cycles post autologous stem cell     transplant (ASCT). This will be followed by up to 6 additional monthly cycles of durvalumab     alone.   "
43460|NCT02716792|"     This study will evaluate renal function in participants with metastatic bone disease due to     breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams     (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate     in the 2 groups of participants will also be compared. The anticipated time on study     treatment is 7 months, and the target sample size is 318 individuals.   "
43461|NCT02716779|"     This study examined the influence of ribavirin on the initial virological response in     treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were     randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000     milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon     (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks.     Following the initial 6 weeks, all participants received combination therapy with PEG-IFN     alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response     after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks     outside of the study.   "
43463|NCT02716753|"     All couples planned for IVF will be asked to participate. After information and received     informed consent they will be randomized into two groups.      At the time for ovum pick up during an IVF procedure either half of the amount of seminal     plasma or the same amount of physiological NaCl solution will be installed around the     external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl     solution will be prepared according to a prearranged randomization list by a technician.      The success rate will be the number of diagnosed pregnancies and live births.   "
43464|NCT02716740|"     Despite the demonstrable health and quality of life benefits, there are unknowns within     consequences of obesity surgery. Weight loss composition is poorly understood. The objective     is to have a significant loss of body fat and a limited loss of muscular weight.      A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and     1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little     loss' and is defined by a contribution of muscular weight lower than 15% of the total weight     loss. The other one is called 'big loss' and is defined by a contribution of muscular weight     higher than 15% of the total weight loss. Causes of these different phenotypes are unknown     for the moment.      Some amino acids have an anabolic potential. Leucine induces a muscular protein synthesis in     clinical situations like hepatic cirrhosis, and some populations like new born and older     people.      Assuming that, a leucine-enriched essential amino acid supplementation will have a benefit     effect on the muscular mass. That is testing the influence of the quality of protein     consumed, more than the quantity. An anabolic substance (amino acid here) can lead to gain of     muscle only if it is associated to regular physical training, all patients will follow a     physical training.   "
43465|NCT02716727|"     Purpose: To compare the quality of impressions made with a cordless gingival displacement     procedure versus impressions made with a corded technique. The devices and materials used in     both procedures are FDA-approved, marketed, and will be used according to label.      Participants: Approximately sixty (60) adult patients who are treatment planned for indirect     restorations (crowns) at the UNC School of Dentistry. Procedures (methods): Participants will     be randomized to receive either the cordless gingival displacement procedure (Aquasil Ultra     Cordless, Dentsply), or the corded technique (Ultrapak, Intradent) followed by impression     with Aquasil Ultra, Dentsply. Participants will complete the Faces pain scale. Impressions     will be photographed, digitally scanned, and evaluated.   "
43466|NCT02716714|"     This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp     & 0.05% on trunk and extremities in Korean patient with actinic keratosis.   "
43467|NCT02716701|"     Exercise therapy in MS patients has proven benefits on mobility, mood, motor function and     quality of life. While the beneficial effects of exercise on cardiovascular and     musculoskeletal function are well known, there has recently been increased focus on the     positive effects of exercise on brain structure and function. The goal of this study is to     determine whether exercise can promote beneficial changes in brain function in MS patients.   "
43468|NCT02716688|"     To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older     patients with esophageal cancer.   "
43469|NCT02716675|"     This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)     VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG)     persons who have sex with men, in North America, South America, and Switzerland.   "
43470|NCT02716662|"     The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with     ALS. The reason why the investigator wants to use AC-1204 in patients with ALS is to     determine if, by taking AC-1204, the body will make substances called ketone bodies. Further,     if AC-1204 is well tolerated, the investigators want to change the amount the participant     takes, to determine if the amount of ketone bodies in the blood increase in accordance with     increases in the amount of AC-1204 the participant takes. The investigators want to do this     study because when the investigators gave AC-1204 to mice with ALS, findings suggest the     disease course is altered for the better and that the cause of this change is due to the     presence of ketones in the blood. If AC-1204 can be proven to be safe and able to cause     ketones to increase in the blood, the investigators will likely do subsequent studies to     determine if the presence of ketone bodies will slow or stop the progression of the disease.     However, this study is not designed to determine if AC-1204 will stop or slow the progression     of ALS. It is designed to only determine if patients with ALS can tolerate AC-1204, if ketone     bodies are produced and if the amount of ketone bodies produced increases with increasing     dose.   "
43471|NCT02716649|"     In this project, we derive survival risk ratios (SRR) based on International Classification     of Disease version 10 (ICD-10) injury codes to validate the ICD Injury Severity Score (ICISS)     in data from four public university hospitals in India.   "
43472|NCT02716636|"     The purpose of the study is to investigate whether the speed of tenaculum placement affects     perceived patient pain during office transcervical procedures.   "
43473|NCT02716623|"     The purpose of this study is to learn if bladder cancer patients can follow a diet and     exercise program during treatment and whether the program will improve results of their     treatment.   "
43474|NCT02716610|"     Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501     inhaled human insulin   "
49088|NCT02643095|"     This study will be done with subjects who already habitually wear scleral contact lenses. The     study lens is made with a material that is already widely available and has a new design. It     will be fit by the investigators and will be assessed and at one week and 1 month.   "
43498|NCT02716298|"     This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear     modality over approximately 1 month in comparison to the lotrafilcon B lens.   "
43499|NCT02716285|"     Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS)     symptoms in several meta-analyses. However, the level of evidence is moderate and peppermint     oil remains relatively under-used in IBS. Therefore, the investigators will conduct a     multicenter randomized, placebo controlled trial to investigate the effects of an eight-week     peppermint oil treatment in IBS patients according to current European Medicines Agency (EMA)     / US Food and Drug Administration (FDA) guidelines. To improve efficacy and to reduce side     effects, the investigators aim to study the use of a new peppermint oil formulation, a     colon-targeted-delivery capsule that will release the oil in the (ileo-) colonic region     specifically.   "
43475|NCT02716597|"     The role of albumin in sepsis has been controversial for decades. Although hypoalbuminemia     has been associated with worse outcomes in sepsis, definitive evidence does not exist that     replacing albumin in these patients improves outcomes. However, subgroup analyses from large     clinical trials indicate that albumin may reduce mortality in septic shock, and in     particular, may reduce the time a patient requires vasopressor support. Given this     background, we are conducting this study to evaluate the role of albumin replacement in the     patient with resolving septic shock to determine if albumin administration reduces the time a     patient requires vasopressor support, reduces the time required for central line, and     ultimately whether any potential benefit in terms of reduction of vasopressor support is     associated with ICU length of stay and other outcomes. The approach is unique from larger     trials of albumin in that it is a septic shock study geared at a particular phenotype of the     patient in septic shock and evaluating a specific intervention at a specific time point in     the course of septic shock.   "
43476|NCT02716584|"     Impairments in social integration, characterized by low marriage rates, few friendships, and     a high frequency of living alone, affect the vast majority of Veterans with schizophrenia.     The primary aim of this proposal is to test the efficacy of a novel rehabilitation treatment     approach, engaging in physical exercise, at improving two determinants of social integration     which are impaired in schizophrenia: cognition and affect.   "
43477|NCT02716571|"     This study on manufacture of MG4101 (allogeneic natural killer cell) to use for     Hepatocellular carcinoma(HCC) after Transarterial Chemoembolization(TACE) will be harvested     WBC(white blood cell) and plasma from healthy donors, or plasma from healthy donors by     leukapheresis or plasmapheresis procedure.   "
43478|NCT02716558|"     It is a clinical trial which employs a split mouth design to assess the retention of a     moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants     on a representative sample of 7- 12 year old school children of a district in Belgaum,     Karnataka, India.   "
43479|NCT02716545|"     Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or     chronic gastrointestinal bleeding, consequently is in dire of effective treatment. The     investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was safe     and effective. This trial intends to investigate the efficiency of endoscopic intervention to     the hemorrhage due to GIVM. What more, the research tends to suggest standardizing clinical     paths for small bowel bleeding due to GIVM.   "
43480|NCT02716532|"     This study will be targeting patients suffering from acute brain injury (ABI), including     those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid     hemorrhage (aSAH).      This clinical study is an open-label, non-randomized, single-center, exploratory metabolic     study.      The primary objective is to determine changes from baseline (before enteral administration of     Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI     patients upon Peptamen AF nutritional support.   "
43481|NCT02716519|"     This study is designed to assess the comparative effectiveness of SANTYL® versus standard of     care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of     care of an ACO. After meeting study criteria, participants will be randomly assigned to apply     Santyl or standard care to their pressure ulcer or diabetic foot ulcer for up to 6 weeks.     Participants will be followed for one year from the date of randomization to assess ulcer     status and ulcer complications.   "
43482|NCT02716506|"     The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse     (POP) surgery. In this multi center study the population consists of POP operations done in     Finland year 2015.The study is prospective and validated questionnaires are used to measure     the symptoms of POP and the quality of life before and six months after the operation.     Methods and complications of surgery are reported by doctors in all 40 participant hospitals.   "
43483|NCT02716493|"     Exercise-based rehabilitation improves physical function, fatigue and quality of life in     patients with thoracic neoplasia. Consequently, the need for rehabilitation across the     continuum of care in oncology is growing rapidly. However, the implementation of this type of     intervention is limited because of many barriers such as patients' symptoms and poor     accessibility to programs. In this context, healthcare systems should develop and implement     new approaches to dispense these services. Consequently, telerehabilitation is a promising     strategy to improve access and adherence to rehabilitation.      OBJECTIVES To investigate the feasibility, adherence and satisfaction of a home-based     telerehabilitation program (TELERP) with real-time physiological parameters acquisition in     patients with unresectable thoracic neoplasia receiving chemotherapy and to explore its     effects on patients' functional capacity.      METHODS Five patients receiving chemotherapy followed an 8-week TELERP using real-time     monitoring combined with interactive exercises. The TELERP included supervised (15) and     unsupervised (9) strengthening and cardiovascular exercise sessions at a rate of 3     sessions/week. The feasibility of the TELERP, adverse outcomes, technical issues, program     adherence and satisfaction were analysed. Prior to and after the program, a six-minute     walking test (6MWT), a timed up and go (TUG) and a timed stair test (TST) were done to assess     functional capacity   "
43484|NCT02716480|"     The goal of clinical trial is to evaluate the impact of use of health-connected devices and     of an Internet-based Intensive follow-up on physical activity recovery during the 6-month     period after bariatric surgery in obese patients.   "
43485|NCT02716467|"     Living with breast cancer and forms of treatment, among them radiation therapy can cause both     side effects such as pain, fatigue and skin changes that affect the well-being, as anxiety,     feelings of isolation and changes in routine, which generate existential conflicts and allow     the origin of the spiritual anguish phenomenon, which in turn, aggravates the physical and     emotional symptoms and the ability to fight the disease. Thus, this study aims to evaluate     the effect of intercessory prayer on levels of spiritual distress, religious / spiritual     coping, psychological morbidity (anxiety and depression) and amylase levels salivary present     in patients with breast cancer radiotherapy.   "
43486|NCT02716454|"     This study compares the efficacy of early surgical with medical treatment in patients with     ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal     ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up     pharmacological therapy.   "
49089|NCT02643082|"     Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes     and Resistance With Moderate to Severe COPD.   "
43487|NCT02716441|"     This proposal's objective is to challenge and expand the current definition of rotator cuff     healing by investigating tendon retraction - broadly defined as medial translation of the     repaired tendon away from the bone with or without a defect - as a common and clinically     predictive structural outcome following rotator cuff repair. The investigators' central     hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon     of rotator cuff healing that is significantly and meaningfully correlated with clinical     outcomes. The investigators' approach is to characterize tendon retraction using an array of     implanted radio-opaque markers, and investigate its relationship to pre-operative tissue     quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a     125-patient prospective cohort study. These patients will complete validated questionnaires     pre- and 6 weeks post-operatively, and repeat these questionnaires as well as undergo MRI     (repair integrity), CT imaging (tendon retraction by radio-opaque markers) and strength     testing at 3, 6, 12 and 24 months.   "
43488|NCT02716428|"     Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir     and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in     treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.   "
43489|NCT02716415|"     The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and     Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper     dermatitis among Neonates and Infants.   "
43490|NCT02716402|"     The purpose of the study is to examine previously examined patients with cyanotic congenital     heart disease to assess how many of the patients have obtained additional blood clots since     they were examined 8 years ago.   "
43491|NCT02716389|"     The measurement of cervical spine range of motion (ROM) figures among the most common aspects     of clinical diagnosis. Good reliability has been demonstrated for assessments using     ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in     contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in the     sagittal plane), separating the respective components provides less reliable results. Current     research suggest that this is due to the participants' determination of the zero position.     This position is influenced by possible disposed treatments and, in particular, by the     subject in case of subjective determination. The present study therefore aims to examine the     test-retest reliability of separate ROM assessments using a bulls eye spirit meter.      Twenty healthy participants will be included in the trial that adopts a two-armed randomized,     crossover design. With a washout-period of one week in between, each subject participates in     two sessions in a randomised order. In both sessions, cervical ROM (flexion/extension,     rotation, lateral flexion) will be measured twice (with a five-minute wait period). In all     measurements, the zero position will be determined by means of a bulls eye spirit level. The     difference of the two sessions consists in the design of the waiting period. In one session,     the subjects will keep the mask carrying the ultrasound markers on their head. In the other     session, the mask will be removed during the break.   "
43492|NCT02716376|"     To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after     radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian     tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby     better hearing and ear related quality of life after cancer treatment.   "
43493|NCT02716363|"     Current guidelines recommend the use of rotational atherectomy (RA) for preparation of     heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or     adequately dilated before planned stenting (bailout situations). RA emerged in the 1990s as     one of several tools to treat luminal obstruction via physical removal of plaque. Although     initially explored as an alternative to balloon angioplasty, RA has shown favorable acute     results in facilitating stent delivery and adequate expansion, particularly those affected by     heavy calcification.Drug-eluting stents (DES) have substantially reduced re-stenosis rates in     randomized clinical trials evaluating simple de novo coronary artery lesions and have also     shown favorable results when implanted in complex lesions and patients, but higher event     rates are observed when treating such subsets compared with simple lesions even with newer     generation DES. However, there are limited data on evaluating the safety and effectiveness of     RA followed by DES implantation for heavily calcified lesions in contemporary practice.     Recent randomized controlled trial shows that RA before paclitaxel eluting stent implantation     as first generation DES was not superior to paclitaxel eluting stent implantation without     prior RA in reducing the primary endpoint of in-stent late luminal loss at 9 months,     indicating that RA does not increase the efficacy of DES in patients with moderate to severe     calcified lesions. However, there were only 15 (12.5%) crossovers from standard therapy to     rotablation because of failure of balloon or stent delivery or suboptimal balloon expansion     despite the use of a noncompliant balloon. Accordingly, procedural and fluoroscopy times were     longer in the elective RA and procedural complications occurred equally in both elective RA     and bailout RA. These findings might cause by a substantial portion of enrolled population     have moderate calcified lesions, but not severe calcified lesions. In particular,     everolimus-eluting stent (EES) as newer generation DES could act synergistically in heavily     calcified lesions as RA could avert stent coating damage and EES could effectively suppress     neointimal proliferation. Therefore, we compare in-hospital and long-term efficacy or safety     of elective RA versus bailout RA and low-volume operator versus high-volume operator in     patients with severe calcified lesions treated with EES.   "
43494|NCT02716350|"     To investigate the potential of B-GOS to beneficially influence the wellbeing and ageing in     healthy adults (52-65 years old). The study will consist of a 4 month randomised double blind     parallel treatment period with either B-GOS of Placebo, and 1 month follow up period without     treatments.   "
43495|NCT02716337|"     The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is     of utmost importance. Standard fortification is the most commonly used supplementation     practice but it does not consider the native variability of human milk. Data on efficacy and     safety of prolonged target fortification are scarce. The investigators performed a     prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to     test efficacy and metabolic safety of target fortification in these preterm infants.   "
43496|NCT02716324|"     The purpose of this study is to explore whether using an online patient portal plus a Care     Manager is more effective than using an online portal alone in managing care for children     with ADHD. Doctors at The Children's Hospital of Philadelphia currently use the online     patient portal to help gather information from parents and teachers on ADHD symptoms,     treatment, and medication side effects. The Care Manager is a person who meets with     participants during the study to discuss their child's ADHD care. The Care Manager     communicates with the child's doctor and teacher to communicate a parent's goals and     preferences for their child's ADHD care.   "
44189|NCT02707289|"     Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites,     during up to 3 years and transferred to Given Imaging. Demographical data and medical history     will be collected. Capsule transit time in the different sections of the GI will be     evaluated.   "
43503|NCT02716233|"     A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an     extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the     adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering     ASNase results in the depletion of asparagine circulating in the blood, which starves the     leukemic cells and results in their death. But indeed the use of ASNase varies between     protocols considering the different brands, the dose and the administration modalities.     Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of     reducing the immunogenicity of the native ASNase.      This is a French prospective multicentric cohort study of children and adolescents with ALL,     stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3     groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).      It aims to answer to two different issues:        1. Randomized question: what is the best way to administer pegaspargase? A cohort of          children and adolescents with standard or medium risk ALL will be randomized to receive          during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of          ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or          1250 IU/m2 per dose during consolidation and delayed intensification according to the          initial arm of randomization.        2. Non randomized question: In the High/Very High Risk groups, a non randomized          intensification of the scheme of asparaginase administration is proposed during          induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered. All          patients will receive 2500 IU/m2 per dose during consolidation and delayed          intensifications.   "
43504|NCT02716220|"     BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute     clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary     artery lesions.   "
43505|NCT02716207|"     The maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with     CyberKnife SBRT will be evaluated.   "
43506|NCT02716194|"     1. To assess tolerability and safety of BAX 826 after a single infusion in previously          treated patients (PTPs) with severe hemophilia A        2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE        3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)   "
43507|NCT02716181|"     A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the Атопик     Soothing Cream in Children with Mild to Moderate Atopic Dermatitis   "
43508|NCT02716168|"     Background International guidelines underline the importance of strengthening the     coordination and continuity of cancer care. The different roles of general practitioners and     oncologists with regard to treatment, follow-up and rehabilitation during and after cancer     treatment are often obscure to cancer patients. Parallel courses of healthcare are often     taking place instead of coordinated care characterized by continuity and partnership between     care providers. Patients may feel uncertain about the health professionals' skills and area     of responsibility. Healthcare seeking and support during and after cancer treatment may,     therefore, be inappropriate, leaving patients feeling insecure and lost between care     providers.The study aims to design and evaluate a new way of communication and shared     decision-making that brings the patient, the oncologist and general practitioner together in     a shared video-consultation in the early phase of chemotherapeutic treatment. The effect of     the intervention in addition to usual care will be tested in a randomized controlled trial at     Vejle Hospital in the Region of Southern Denmark. Based on sample size calculation,     investigators intent to include 300 patients at the Department of Oncology and their general     practitioners. Results and process outcomes will be evaluated qualitatively and     quantitatively, questionnaires to patients, general practitioners and oncologists, and data     from registers.   "
43511|NCT02716116|"     The purpose of this phase 1/2 study is to evaluate the safety, pharmacokinetics, and     anti-tumor activity of oral AP32788 in patients with non-small cell lung cancer (NSCLC). The     trial will be conducted in two parts: a dose escalation phase, followed by an expansion     phase. The goal of the dose escalation phase is to determine the safety profile of orally     administered AP32788, including the maximum tolerated dose (MTD), dose limiting toxicities     (DLTs), recommended phased 2 dose (RP2D) and pharmacokinetic profile. Once the RP2D is     established, the expansion phase will assess the preliminary anti-tumor activity of AP32788     in 4 histologically and molecularly defined NSCLC cohorts. Approximately 105 patients will be     enrolled.   "
43512|NCT02716103|"     In this study, the investigators seek to evaluate bone marrow and blood samples and treatment     responses to see if Minimal Residual Disease (MRD) can be used as a predictive method of     response to treatment in amyloidosis.   "
43513|NCT02716090|"     This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo®     medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other     half will receive Epiduo®.   "
43514|NCT02716077|"     Adult patients with histologically proven melanoma who will be treated with pembrolizumab     will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG     uptake will be correlated with lab and pathology results.   "
43515|NCT02716064|"     TAPESTRY-CM pilot study is a 12-week pilot test of the TAPESTRY-CM using a web application     (APP) to help patient manage their diabetes and hypertension and other chronic conditions by     assisting them in setting goals and connecting them to their healthcare team.   "
43516|NCT02716051|"     Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in     detection of nodes in patients with cell lung cancer (NSCLC).      However, the cardiorespiratory synchronization in the MRI, allowing acquisition of     synchronous images with breathing and heart movements should increase the sensitivity of     detection of pathologic mediastinal lymph nodes.      Given its high sensitivity, whole-body MRI with diffusion could possibly be at least as     informative as PET, while being less expensive, not radiant.      The purpose of this study is to evaluate the performance of whole-body MRI with diffusion     with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are     known to be less well detected by MRI) compared to PET.   "
43517|NCT02716038|"     This is a research study to test the effectiveness of nab-paclitaxel + carboplatin +     MPDL3280A for treatment of non-small-cell lung carcinoma (NSCLC), which is a type of lung     cancer. The study aims to determine if chemotherapy combined with immune-based therapy can     lead to improvement in tumor response rates over historical response rates with chemotherapy     alone.   "
43518|NCT02716025|"     Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included.     All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal     endoscopy and rapid urease test. Measurement of serum zinc level was done for all the     included patients in addition to twenty five age and sex matched healthy control subjects.   "
43519|NCT02716012|"     This is a First in Human study of a new single agent (MTL-CEBPA) in patients with advanced     cancer of the liver. The study is in two parts: dose escalation followed by a dose expansion;     both parts of the study will recruit advanced hepatocellular carcinoma patients with     cirrhosis. All participants will be refractory to or ineligible for loco-regional therapy     including surgery, radiofrequency tumour ablation, transarterial chemoembolisation or     sorafenib.      MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES® liposomal     nanoparticle and is designed to activate the CEBPA gene.   "
43520|NCT02715999|"     The purpose of this research study is to find the best way to decrease pain in children whom     have had low abdominal surgery. Investigators will perform two technique of trunk block;     Transversus abdominis plane or Quadratus lumborum block .The method used is often chosen by     which one the doctor has more experience using. The Investigator plans to find out if one of     the methods is more effective and/or safer than the other method.      The results of this study will help learn how to best control pain in children having surgery     low abdominal surgery.   "
43521|NCT02715986|"     Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant     depression whose effectiveness has been demonstrated. However, the brain mechanisms     underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic     action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of     glial cells. In addition, functional imaging of resting state type have shown, among     depressed patients after ECT, increased functional connectivity . These results were     reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it     seems appropriate to continue research neuroanatomical correlates subtending neurofunctional     processes responsible at the same time improving the clinical depressive. The investigators     suggest using an original technique never used in this type of population: Functional     magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will allow     us to study the impact of ECT on brain structures involved in major depressive disorder:     hippocampus.   "
43522|NCT02715973|"     Children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to 3     yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously     prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/mL, prepared from     locally available, affordable, socially acceptable food items - milk, sugar, edible coconut     oil, egg and custard powder as base) in addition to standard nutritional counseling by a     trained dietician (Group A). The control group (Group B) in comparison will receive standard     nutritional counseling from a trained dietician but will not receive any additional     nutritional supplement. All the children will be followed up at 1 month, 3 months, 6 months,     9 months and 1 year after inclusion. Clinical, nutritional assessment and laboratory data     will be collected at each visit. Additionally IL-6 levels will be done at each visit in     children of both arms of the intervention group.      The outcomes of interest will be growth and improvement of nutritional status parameters,     hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {SBP (Spontaneous     Bacterial Peritonitis), HRS (Hepatorenal Syndrome), etc and outcome (improvement, death or     Liver Transplantation}.      All children will receive individualized standard treatment for infantile cholestasis     syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for SBP     (Spontaneous Bacterial Peritonitis)/cholangitis (to at risk children) and drug therapy     wherever indicated (steroids/ copper chelation/ UDCA).   "
43526|NCT02715921|"     Fitness in patients with Cystic fibrosis (CF) is an important biomarker associated with     higher survivability and improved quality of life. CF patients are encouraged to maintain an     active lifestyle, however, while physicians are able to prescribe airway clearance measures     or specific medications, there is no prescription for exercise or avenue to promote exercise     outside the clinic or hospital.      The advent of ubiquitous computing has transformed the landscape of healthcare delivery. Thus     far, exercise training in CF have either required patients travel to a gym or relied on home     visits or telephone calls. Virtual visits provide a novel and innovative platform to deliver     a live stream of exercise sessions with two-way video and audio capabilities, allowing     individualized attention to exercise for CF patient from the comfort and privacy of their     homes. Applications of tele-exercise, or tele-rehabilitation, have been shown to be as     effective as in conventional physical therapy following orthopedic surgeries and, in stroke     patients, to optimize patient outcome by prolonging duration of treatment and preventing the     observed decline after the termination of therapy. For CF patients, the latter is especially     important given the impact of hospitalizations for acute exacerbations on exercise tolerance.     In this particular population, where cross-contamination risks limit use of group exercise     activity, using two-way video telecommunication allows participation in exercise programs     while adhering to the standards of CF management regarding infection control.      This study would be the first to evaluate implementing tele-exercise and remote monitoring     program on pediatric CF patients. Our pediatric CF patients will be enrolled in a six-week     exercise program that is streamed live from an instructor into their computers at home via a     HIPAA compliant telemedicine platform. Remote monitoring devices, such as accelerometers and     wireless heart rate monitors, will evaluate baseline habitual activity and intensity of     exercise, respectively. The goal of this study is to show that tele-exercise program is a     feasible and convenient and cost-effective method to enhance CF care for our patients.   "
43527|NCT02715908|"     To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg     subcutaneous weekly injection when co-administered with MTX   "
43528|NCT02715895|"     Compared with breast milk and another commercially available formula, infants' growth rate     after 12 weeks' Friso formula with different ways of processing feeding will be assessed.   "
43529|NCT02715882|"     Randomized Single-blind Placebo-controlled Clinical Study of Safety and Tolerability of     CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer, With Different Doses     and Regimens   "
43530|NCT02715869|"     Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart     from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).   "
43531|NCT02715856|"     The goal of this study is to learn about performing follow-up care using mobile devices     (smartphones or tablet computers) after surgery.   "
43545|NCT02715674|"     This study will compare the effectiveness of postoperative incentive spirometry and     noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients.     Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a     CPAP (continuous positive airway pressure) group (G-CPAP, n:20)   "
43532|NCT02715843|"     This is an active treatment, extended access study open solely to those subjects who have     successfully completed the Core and Repeat Dosing portions of the MT-3724_NHL_001_US clinical     study and who, in the investigator's judgment, (i) have not had progressive disease while on     MT-3724 treatment (i.e.; have shown a complete or partial response or stable disease), (ii)     have experienced no clinical or laboratory toxicities that would contraindicate further     MT-3724 dosing and (iii) have no acceptable and better alternative treatment available to     them.   "
43533|NCT02715830|"     It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in     which 40 procedures to treat one artery (standart) or more than one artery in the same     procedure.      The aim of this study is to know if this strategy increase healing velocity and limb salvage.   "
43534|NCT02715817|"     The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and     therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the     balance of poststroke hemiparesis patients and the impact on quality of life.   "
43535|NCT02715804|"     The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant     Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment),     compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in     participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal     adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.   "
43536|NCT02715791|"     The TAPESTRY-HC-DM approach is designed to support self-management of chronic disease by     strengthening connections between patients and the primary healthcare system through health     connectors -both volunteers and technology including the TAPESTRY Healthy Lifestyle App and     McMaster Personal Health Record (PHR). It will explore whether strengthening primary care     connections across patients, providers, and community organizations through TAPESTRY-HC-DM -     i.e., the deployment of volunteer health connectors coordinated by a community organization,     the use of the TAPESTRY Healthy Lifestyle e-Application by patients, and care coordination     processes by the interprofessional primary healthcare team - can increase self-efficacy in     managing chronic conditions.   "
43537|NCT02715778|"     Although the last decade has brought major advances with respect to our knowledge of certain     risks associated with fetal exposure to psychiatric medications, critical information     regarding the long-term neurobehavioral impact of fetal exposure is lacking. With a     prevalence rate of selective serotonin reuptake inhibitor (SSRI) use across pregnancy in     Western countries noted to be as high as 5-8%, this study aims to close the gap in knowledge     regarding long-term neurobehavioral sequelae of in utero exposure to this class of     antidepressants. Importantly, the assessment of the impact of antenatal psychotropic     medication use must be conducted with an appreciation of the potential direct and indirect     effects of maternal psychiatric illness during pregnancy and throughout childhood. The     outcomes of this study will help to inform the care of reproductive age women treated with     psychiatric medications as they, along with the clinicians prescribing for them, weigh the     relative risks of using these agents during pregnancy.   "
43538|NCT02715765|"     Schizophrenia is a serious mental health disorder that affects approximately 1% of the     population. Auditory hallucinations are present in as many as 50-75% of patients with this     diagnosis. The hallucinations experienced by patients vary greatly and can severely impact an     individual's ability to function on a daily basis. In approximately 25-30% of these patients,     medication is an ineffective mechanism for managing these symptoms. These hallucinations are     known as medication refractory auditory hallucination (MRAH). For those whose auditory     hallucinations do not respond to medication, non-surgical brain stimulation (NBS) has     recently shown promise as a therapeutic intervention. Two specific types of NBS, called     transcranial direct current stimulation (tDCS) and transcranial random noise stimulation     (tRNS), seem particularly well suited to treating MRAH. They have yet to be compared to each     other in large samples of patients with MRAH. The goal of the study is to investigate whether     tRNS and tDCS are effective in the treatment of MRAH and if one is better than the other when     compared directly.   "
43541|NCT02715726|"     Primary Objective:      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in     comparison to ezetimibe as add-on therapy to stable maximally tolerated daily statin therapy     in high cardiovascular (CV) risk patients with hypercholesterolemia in Asia.      Secondary Objectives:        -  To evaluate the effect of alirocumab on other lipid parameters: eg, Apolipoprotein (Apo)          B, non-HDL-C, total cholesterol (TC), lipoprotein a (Lp[a]), high-density lipoprotein          cholesterol (HDL-C), triglycerides (TG), and Apo A-1.        -  To evaluate the safety and tolerability of alirocumab.        -  To evaluate the development of anti-alirocumab antibodies.        -  To evaluate the pharmacokinetics (PK) of alirocumab.   "
43542|NCT02715713|"     The primary goal of this pilot study is to investigate the association between testosterone     deficiency and the presence of abnormalities in the function of the autonomic nervous system.     If such association exists, then we will investigate the effect of testosterone replacement     therapy on correcting these abnormalities.   "
43543|NCT02715700|"     This study will evaluate the effects of multiple doses of MK-1439 (doravirine) on the     pharmacokinetics of methadone in participants requiring methadone maintenance therapy. The     primary hypothesis is that the Area Under the Concentration-Time curve to 24 hours (AUC0-24)     of (R)-methadone is similar when a maintenance regimen of methadone is administered with or     without multiple daily doses of MK-1439.   "
43544|NCT02715687|"     Post-operative atrial fibrillation (POAF) is the most common complication encountered after     cardiac surgery; reports show POAF to occur in ~ 35% of patients after CABG. Prophylactic use     amiodarone was found to be effective, however, due to serious extracardiac adverse effects     therapy is probably appropriate just for patients at high risk for POAF.      the common practice for management of POAF is treatment with intravenous Amiodarone until     return to sinus rhythm, following which the drug is given orally. Our protocol involves     continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of     200mg per day.      This protocol is a common practice in many cardiac surgical departments worldwide,     nevertheless, it is not evidence-based protocol and it was never examined as such.      This study is a randomized placebo controlled trial, to evaluate the requirement for     post-discharge treatment with oral Amiodarone.   "
43546|NCT02715661|"     This project will examine the association between (cardio)vascular disease, blood supply to     the brain, and cerebrovascular endothelial activation. Also, we will investigate the impact     of exercise rehabilitation on brain vascularization, cerebrovascular endothelial function and     blood flow control.   "
43547|NCT02715648|"     The investigators propose to conduct a randomized controlled trial to evaluate whether     administration of phenazopyridine prior to the procedure decreases office cystoscopy time.     Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.   "
43548|NCT02715635|"     The principal research objective is to determine whether inorganic nitrate in the form of     beetroot juice compared to placebo control prevents the systemic inflammation that underlies     typhoid vaccine-induced endothelial dysfunction   "
43549|NCT02715622|"     The objective of this prospective, multi-center post-market study is to prospectively collect     uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic     assisted hernia repair.      The outcomes that will be collected include various routine clinical parameters, short term     patient reported outcomes (quality of life, pain scores) and long term hernia recurrence     information. Patients will be treated according to standard of care at the surgeon's     institution and patients will be followed up to collect information related to complications     information and patient satisfaction associated with the hernia repair procedure.   "
43550|NCT02715609|"     The proposed study will be a multi-institutional, phase I/II study of disulfiram (DSF) for     patients with presumed glioblastoma multiforme (GBM) based on magnetic resonance imaging     (MRI) or biopsy, including administration before surgery and during adjuvant     chemoradiotherapy. Patients will be treated with 3 days of preoperative DSF/copper (Cu) prior     to their surgery (or biopsy), which will be followed by collection of blood and tumor samples     during surgery for analysis of drug uptake. After the surgery, patients will receive standard     radiation therapy (RT) and temozolomide (TMZ) with the addition of concurrent DSF/Cu.   "
43551|NCT02715596|"     Evaluates the effect of EPA supplementation in terms of muscle mass in patients with squamous     cell carcinoma of the head and neck locally advanced   "
43552|NCT02715583|"     Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease     planning to undergo Ra-223 therapy may be eligible for this study. Positron emission     tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging     will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care     99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy   "
43553|NCT02715570|"     PC945 is a new medicine being developed for treatment of fungal lung diseases. The main     purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     single and repeat doses of PC945   "
43563|NCT02715440|"     Intervention randomized controlled open study with 2 parallel arms . The objective of this     study is to evaluate the feasibility of stopping the benzodiazepines treatment in elderly     living in nursing homes.      It will check that the judgment of these molecules has no pejorative effect on sleep or     behavior of residents and does not induce withdrawal syndrome. Two patient groups will be     constituted. One will begin a gradual withdrawal of benzodiazepines in six weeks. The other     group will continue his treatment and withdrawal will be proposed after 8 weeks by his     general practitioner (delayed intervention).      Effects on sleep will be assessed by wrist actimetry for 10 weeks and a sleep diary . The     repercussions of withdrawal on behavior will be rated by the NPI scale.   "
43715|NCT02713464|"     This study examines (a) whether introduction of public, health provider, and maternal     education about risks of jaundice will decrease the occurrence of ABE compared with baseline     prevalence (before-after design) or (b) whether antenatal or postpartum instruction to     mothers will decrease the incidence of ABE compared with those who did not received     instruction (concurrent opportunistic controls in phase 2).   "
43554|NCT02715557|"     In Phase I of this SBIR project, 3C Institute (3C) developed a working prototype of an     innovative computer-based coping skills educational program for adolescent substance abuse     treatment completers. For Phase I, 3C developed and tested two customizable intelligent     educational modules to teach coping skills in order to help adolescents avoid relapse, along     with a brief instructional game for each segment. The Phase I prototype also included an     online Parent Guide to inform parents about the uses and benefits of the product. Phase I R&D     provided strong support for the quality and value of the prototype as well as the viability     of the proposed educational package and its promise for preventing substance abuse relapse     with adolescents. Phase I results supported excellent quality of the product through high     ratings of quality, appeal, and value. High feasibility and usability was also demonstrated     through high ratings for ease of use, usability, and potential effectiveness.      The goal of this Phase II SBIR project is to modify and expand the relapse prevention program     developed in Phase I in response to customer feedback and to evaluate the efficacy of the     full program with an RCT pilot clinical study. This product will be an adaptable software     program for aftercare therapy. In Phase II, the investigators will build on the Phase I     findings to modify and extend the existing content and develop the full program, which will     include: an introductory module as well as interactive lessons and skill-building games for     five coping skills modules. The Phase II product will also include a HelpCenter to support     sustained, quality use of the product during commercialization.   "
43573|NCT02715310|"     In order to estimate the effect of fluid management in regard to postoperative complications     this observatory study will document every kind of fluid intervention peri- and     intraoperatively.   "
43574|NCT02715297|"     This multi-center randomized controlled phase II trial will investigate the impact of     stereotactic fractionated radiotherapy to the resection cavity of complete resected recurrent     glioblastoma on progression free survival. As secondary endpoints, overall survival, safety     and toxicity as well as early response criteria on MRI, quality of life and neurocognitive     function will be assessed. Chemotherapy will not be part of the protocol, however, additional     treatment will be possible upon investigators best choice.   "
43575|NCT02715284|"     This is a multicenter, open-label, first-in-human Phase 1 study evaluating the     anti-programmed death receptor 1 (anti-PD-1) antibody TSR-042 in patients with advanced solid     tumors who have limited available treatment options. The study will be conducted in 2 parts:     dose escalation and cohort expansion. The cohort expansion may include up to 5 tumor types,     including endometrial and Non-Small Cell Lung cancer.   "
43555|NCT02715544|"     Recent research suggests a majority of Hong Kong's toddlers (aged 2 to 4) are much less     active than is recommended and are increasingly engaged in sedentary behaviour, which places     them at risk of becoming overweight or obese. The proposed project will test whether     connecting families to nature positively influences physical activity (that is, active     playtime) and healthy eating routines in children aged 2 to 4. The investigators have     recently conducted a pilot study Play & Grow (P&G), a programme based on the most successful     international preschool interventions described in the literature. In addition to adopting     healthy eating and physical activity intervention elements, the programme was enhanced by     including a novel third element: connectedness to nature (CN). To test the effectiveness of     this enhanced intervention, the plan is to run a family-based randomised controlled trial     (RCT). The intervention will include 240 families with children aged 2 to 4, will take the     form of one-hour activity sessions for parents and children held once a week for 10 weeks.     The investigators will assess lifestyle-related habits before, immediately after the     completion the intervention, at 6 months and one year after the intervention. Created for     this purpose, a novel measuring tool for connectedness to nature, Nature Relatedness Scale     (NRS), will be validated and tested for reliability prior to the RTC. The results of RCT are     intended to be used to understand which components of the intervention were most effective.     The objectives of this project will be achieved over a 36-month period, and it is expected to     contribute to a close examination of key components of successful healthy lifestyle promotion     programme during early childhood. The investigators predict that is that the new element CN     will significantly improve the intervention. Finally, the overall aim is that connecting     families to nature will result in sustainable lifestyle changes that remain with them for a     lifetime.   "
43556|NCT02715531|"     This study will evaluate the safety, tolerability and pharmacokinetic variability of     atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and     5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU +     cisplatin.   "
43557|NCT02715518|"     The aim of the study is to compare clinical outcomes following fractional flow reserve     (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related     artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel     disease      Prospective, open-label, randomized, multicenter trial to test the clinical outcomes     following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in     patients with acute AMI with multivessel disease.   "
43558|NCT02715505|"     This study is designed to assess the safety and exploratory efficacy of using HSC835 in     patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.   "
43559|NCT02715492|"     Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are     inoperable because of late presentation and underlying cirrhosis. It represents the fifth     most common tumor in the world and the third most frequent cause of mortality amongst     patients with cancer.      Due to the worldwide difficulties in finding liver for transplantation, hepatic resection     (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter     arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable     HCC or for patients not eligible to be operated on .      TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which     could prevent recurrence and improve long-term survival .   "
43560|NCT02715479|"     The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of     Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176   "
43562|NCT02715453|"     Frailty has been associated to a worse outcome in acute coronary syndromes, but the best     management of frail patients after an acute coronary syndrome remains unknown. The aim was to     investigate the benefit of an intervention on frailty in frail patients after an acute     myocardial infarction.      Patients survivors after an acute myocardial infarction (with and without ST-segment     elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points)     according to the Fried's scale measured 24 hours before hospital discharge, will be included.     The participants will be randomized to 2 strategies: a) intervention on frailty in addition     to the usual care by the cardiologist, and b) conventional strategy consisting only of the     usual care by the cardiologist. A multidisciplinary team (physicians, nurses and     physiotherapists and nutritionists) will carry out the intervention on frailty The study     contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included     patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year.     The secondary endpoint will be the clinical events, both cardiovascular and not     cardiovascular events, including recurrent events (cumulative events analysis), for the total     follow up (3 years in the case of the first included patient). The hypothesis is that an     intervention on frailty will improve frailty status and the clinical outcomes in frail     patients after an acute myocardial infarction.   "
44190|NCT02707276|"     The primary aim of this study is to assess the efficacy of Low Field Magnetic Stimulation     (LFMS) in treating symptoms of depression and anxiety in older adults suffering from bipolar     depression. The investigators also aim to assess any cognitive benefits from regular LFMS     treatments in older adults suffering from bipolar depression.   "
43564|NCT02715427|"     Enhanced rehabilitation programs are based on new therapies and treatment combinations to     reduce the length of hospitalization, duration of postoperative convalescence, morbidity, but     also the overall cost of care. The operating stress and hypercatabolic conditions surrounding     the surgery are sources of complications. In this enhanced rehabilitation approach, the     principle is to fight through a series of actions against this surgical stress. Several North     American studies, Chinese, Scandinavian or Batavian have shown the feasibility and the     interest of enhanced perioperative rehabilitation in liver surgery. Nevertheless, there is     not until now French data concerning the assessment of enhanced rehabilitation in liver     surgery. The main objective of the study is to compare the effectiveness of the     implementation of a multimodal management program after liver surgery in a French university     center compared to conventional care. Secondary objectives of the study are to compare an     enhanced rehabilitation program in liver surgery versus conventional treatment in terms of     morbidity and mortality in the immediate postoperative period and until day 90, length of     hospital stay, blood loss and the delay to bowel mobility recovery. Compliance to the program     in both groups will also be evaluated.   "
43577|NCT02715258|"     The purpose of this study is to investigate the effect of bexagliflozin in lowering     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).   "
43578|NCT02715245|"     In this research, investigators pretent to evaluate the effectiveness of clinical,     functional, psychological and social impact of an intervention model based on shared care     between the Mobile Rehabilitation and Physical therapy team (MRPTT) and nurse case managers     of Primary Care in a sample of patients with multiple chronic diseases (comorbidities) and     their caregivers. A non-randomised controlled trial.   "
43565|NCT02715414|"     A multiple family group (MFG) is a family-centered, group delivered, evidence-informed,     manualized intervention that targets the most common reason for referral to publicly funded     clinics: youth oppositional defiant and conduct disorders. This study will employ a mixed     methods Type II effectiveness-implementation hybrid research design.In collaboration with the     NYS Office of Mental Health (OMH), this longitudinal study will be conducted across the NYC     OMH licensed child behavioral health clinic system (n=134). The investigators will use mixed     methods, and involve 268 providers and 2,688 adult caregivers of youth (7 to 11 years).      The following Specific Aims guide this study: To examine 1) short-term and longitudinal     impact of MFGs on urban youth with ODD and CD (replication); 2) family-level mediators (e.g.     parenting, family process) of child outcomes; 3) clinic (readiness to adopt an innovation,     leadership support and climate) and provider level moderators (preparedness, motivation and     fidelity) of MFG implementation and integration and; 4) the impact of CITs on clinic and     provider level moderators of MFG implementation and integration. In this RCT, clinics will be     stratified by borough (Manhattan, Queens, Bronx, Brooklyn, Staten Island) and randomly     assigned within borough to 3 study conditions: 1) MFG+CITs; 2) MFG (with standard research     training and consultation) or; 3) Standard Care. Data will be collected baseline, 8 and 16     weeks and 6 mo. follow-up) in Phase 1 (focus on implementation) and Phase II (integration).   "
43566|NCT02715401|"     To investigate the pharmacokinetic properties and safety after administration of HCP1303 and     co-administration of HGP1201, HIP1402 under Fed Condition in healthy male volunteers   "
43567|NCT02715388|"     Evaluate the use of Elbit's digital electro-optical systems for generating detailed high     quality video imaging during surgery, and thus improving the surgeon's visualization,     performance and outcome.   "
43568|NCT02715375|"     This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double     blind study with an allocation ratio of 1:1. The study population is children between the     ages 6 to 17 years, with mild to moderate persistent asthma. The purpose of the study is to     determine whether the CREON2000A, an environmental control device, will decrease asthma     severity, as measured by the Composite Asthma Severity Index (CASI), in children with mild to     moderate persistent allergic asthma over a twelve month period.   "
43569|NCT02715362|"     Intravenous infusion of CART cells in the treatment of solid tumors may be not a suitable     choice. Because by intravenous infusion, T cells first entered into the blood circulation,     but the number of T cells accumulated at the tumor site is limited, while the probability is     high that CART cells contact with normal tissue where target protein is expressed, leading to     a more potential off-target side effect. In this study, CART cells infused to the body is     mediated by the method of transcatheter arterial infusion(TAI), which is one kind of tumor     intervention therapy pathway. We hope by this means could improve the local CAR-T cell     numbers，meanwhile reduce the potential side effects.   "
43570|NCT02715349|"     Families with a patient with schizophrenia and the patient are randomly assigned to receive     either a 3 session psychoeducation program, or no psychoeducation. Other treatment for     schizophrenia and other mental illness are provided as usual.   "
43571|NCT02715336|"     Individuals undergoing In Vitro Fertilization must undergo controlled ovarian     hyperstimulation (COH) to produce enough quality eggs for fertility treatment. Ovarian     follicular responsiveness to COH with gonadotropins is extremely variable between patients     and even from cycle to cycle for the same patient. Achieving an ideal follicular response is     critical to the success of assisted reproduction treatment (ART). Patients have been     classified as 'poor', 'normal' or 'high' responders, which dictate the amount of     gonadotropins that they receive. It is still important to develop treatments with high     efficacy, lower multiple birth rates, and a lower complication rate for each of these groups.     In an era of evidence-based medicine and with special emphasis on reducing IVF risks (mainly     OHSS and pregnancies with multiples), it is very important to find optimal and safe ovulation     induction and triggering regimens for each patient population.      The use of GnRH agonist (GnRHa) triggering among high responders in order to reduce or     eliminate OHSS is an example of an important breakthrough in the clinical management of IVF     patients. Although GnRHa triggering was shown to be as effective as human chorionic     gonadotropin (hCG) at inducing oocyte maturation more than 20 years ago, its use to trigger     ovulation was not possible until the introduction of GnRH antagonists for pituitary     suppression.      Another prominent trend in ART in recent years has been the introduction of dual triggering,     which involves a combination of GnRHa plus hCG for triggering. This regimen creates     simultaneous lutenizing hormone (LH) and follicle stimulating hormone (FSH) surges by the     GnRHa, which resembles physiologic ovulation triggering, together with sustained LH-like     activity from the hCG, which stimulates the corpus luteum to excrete sufficient hormonal     endometrial support. Since its introduction, dual triggering has been gaining popularity due     to outstanding results in retrospective studies among both normal and high responders.     Moreover, in spite of the encouraging retrospective reports, prospective randomized     controlled trials (RCT) on dual triggering have not been reported to date. The aim of the     current proposed study is to compare the efficacy of dual triggering and conventional     triggering among the three IVF populations (high, normal and poor responders).   "
43585|NCT02715154|"     Current cesarean section often chooses spinal anesthesia. And in order to avoid the impact of     drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or     analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and     other psychological reactions in cesarean section. Although the placental transfer and the     foetal metabolism of dexmedetomidine have been reported and the result show no adverse     effects on neonates, but the placental transfer of dexmedetomidine in intravertebral     anesthesia area was lack of systematical research. This study intends to use of     dexmedetomidine in the cesarean section under epidural anesthesia and investigate its effects     on the parturients' haemodynamics and the neonates' placental transfer and metabolism.   "
43572|NCT02715323|"     Ocular surface disease, especially dry eye and scleritis, commonly affects patients with     autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however     the full subset of immune cells activated is unknown. Recent experimental studies show that     dendritic cells and T cells in the cornea are critically associated with corneal nerve     innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of     dendritic cells and corneal nerves. The investigators propose to investigate how ocular     surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology     interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA),     Systemic lupus erythematosus (SLE).      The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells,     and dendritic cells) can be quantified using minimally invasive impression membranes     (Eyeprim). Clinically, the research team is experienced in measuring features of ocular     surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M.     The investigators also aim to harvest conjunctival immune cells using impression cytology and     quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell     density and distribution will be assessed using CCM; in collaboration with the group who have     pioneered this technique.      The investigator anticipate that alterations in corneal nerve and dendritic cell parameters     will correlate with immune activation/inflammation, deterioration of tear function and     increased systemic severity of the rheumatological disease. In addition, the investigators     hypothesize that the lower the corneal nerve density, the higher the number of corneal     dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a     better mechanistic understanding of local corneal and systemic immune activation and the     development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and     nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new     therapies in autoimmune patients with severe dry eye.   "
43579|NCT02715232|"     The aim of this study is to prove the modulatory influence of sex hormones on serotonergic     neurotransmission by determining the enzymatic processes involved in serotonin synthesis and     degradation using positron emission tomography (PET) in humans in vivo with the radiotracers     [11C]AMT and [11C]harmine.   "
43580|NCT02715219|"     Asthma is an important chronic disease that causes a significant public health problem and     the commonest medical conditions treated in health clinics giving rise to considerable     morbidity and mortality. Several studies suggested that improvement of patient knowledge has     become a key component of asthma management. In the study setting the education material for     Asthma patient is available however the proper cannel to deliver it to patient remains a     puzzle to the researcher, therefore this study is trying to close the gap between Asthma     education material and patient.The aim of the study is to investigate the effectiveness of an     Asthma Education Program (AEP) result in improvement of patient's knowledge, medication     adherence and inhaler technique.This is an experimental study a clinical trials. Data will be     gathered utilising three an adapted instrument to assess patient knowledge of their disease,     medication adherence and inhaler technique. Patients who are came to Asthma Bay in Emergency     Department, Respiratory Clinic for routine follow up and admitted to ward will be recruited     as study subjects. Subject who are agree to enrol in the study will be randomized into     intervention and control group. Subjects in intervention group will be undergone one session     of an AEP, however there are no intervention for control group but continue routinely follow     up in Respiratory Clinic. To obtain the study result descriptive and inferential statistical     analysis will be performed. To analyse the statistical significant of the change in patients'     health outcome the pre and post of AEP independent t-test or chi-square test will be used.The     expected finding of this study is to determine the effectiveness of AEP result in of     patients' knowledge regarding asthma disease, medication adherence and inhaler technique, pre     and post of AEP.      Keywords: asthma, asthma education program.   "
43581|NCT02715206|"     The purpose of this study is to determine if a new substance use prevention curriculum for     rural middle schools is effective in reducing substance use and to study how prevention     curriculum get implemented by teachers.   "
43582|NCT02715193|"     This is a randomized, placebo-controlled, double-blind study to evaluate safety, tolerability     and pharmacodynamics of REMD-477 in subjects who have Type 1 diabetes and are currently     receiving insulin treatment. This proof of concept study will determine whether glucagon     receptor blockade using a single dose REMD-477 can improve short-term glucose homeostasis in     people with Type 1 diabetes.   "
43583|NCT02715180|"     The almost evidences of the optimal hand position during compression had been based on chest     computed tomography (CT) or chest plain films of patients for investigating the effective     location for compressing the left ventricle of the heart during cardiopulmonary resuscitation     (CPR).      However every study was conducted at full inspired state of respiration. A prospective cohort     study to evaluate the proper hand position during CPR based on expired respiratory state CT     as the health screening would be needed.   "
43584|NCT02715167|"     The hypothesis is that a high fractional exhaled nitric oxide can predict the response to     inhaled corticoids in chronic cough.   "
43748|NCT02713035|"     Patients with atopic dermatitis and eczema often struggle with habitual scratching that is     not well-controlled even with optimal medical therapy. Our goal is to create a behavioral     intervention to help children with eczema reduce scratching. The investigators hope that the     intervention will improve clinical outcomes and quality of life, as well as provide an easily     implemented way for clinicians to educate patients and parents about behavioral modification     techniques.   "
43586|NCT02715141|"     Rationale: Since January 2014 the Dutch screening programme for bowel cancer has been     implemented. Screening will increase the demand for surveillance. Although patients in whom     adenomas have been removed are at increased risk of progressing to cancer, solid evidence on     the reduction of death from CRC through the current colonoscopy-based surveillance is     lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high     individual burden and high costs. Therefore, there is need for new surveillance strategies.     Stool-based molecular testing (Cologuard®, consisting of a stool DNA test and an     immunochemical assay for human hemoglobin) or Faecal Immunochemical Testing (FIT) may serve     as an alternative for colonoscopy surveillance.      The aim of this study is to compare the accuracy of an established molecular stool test     (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced     neoplasia) in a surveillance population. These outcomes will be used to model various     strategies of stool-based molecular surveillance to inform health policy decisions.   "
43587|NCT02715128|"     Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Among     others, deficient cognitive control over emotional distraction is a central characteristic of     MDD (Ochsner & Gross 2005; Disner et al. 2011; Beck 2008). Hypoactivation of the dorsolateral     prefrontal cortex (DLPFC) has been linked with this deficit (Dolcos & McCarthy 2006).     Moreover, aberrant functional connectivity patterns have been found in MDD patients (Kaiser     et al. 2015). Transcranial direct current stimulation (tDCS) is a non-invasive brain     stimulation method that has been largely investigated in experimental neurosciences and tDCS     of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. So far,     prefrontal tDCS has been shown to enhance cognitive control over emotional distraction in MDD     patients (Wokenstein & Plewnia 2013). Also, tDCS-induced connectivity changes found in fMRI     studies comparing resting-state networks configurations before and after prefrontal tDCS may     reflect a state of enhanced alertness (Keeser, Meindl, et al., 2011; Park et al., 2013).      The aim of this study is to investigate the neurophysiological correlates of tDCS effects in     MDD patients. For this purpose, functional magnetic resonance imaging (fMRI) data is     collected during the execution of a cognitive control task as well as during a resting-state     condition following real or sham tDCS. It is hypothesized that prefrontal tDCS as compared to     sham a) reduces distractibility by compensating for deficient DLPFC activity and b) enhances     functional connectivity in networks associated with externally directed attention or     cognitive engagement.      In this placebo-controlled study patients with a diagnosis of MDD receive a single treatment     with prefrontal tDCS (anode over electrode position F3, cathode over F4, 20 min, 2mA     intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp     out periods only without intermittent stimulation). Before, during, and after the treatment     resting-state measurements in the fMRI scanner are conducted. Subsequently, participants     perform the cognitive control task (in dependence of Plewnia, C., Schroeder, P. A., &     Wolkenstein, L. (2015)) in the scanner. The patients are assigned to either the real or sham     tDCS condition according to a randomised, double-blind parallel design.   "
43588|NCT02715115|"     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the     treatment of Rett syndrome in children and adolescents.   "
43589|NCT02715102|"     Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic     surgery without a distant history of cancer will have their blood drawn for measurement of     circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the     early detection of lung cancer.   "
43590|NCT02715089|"     The purpose of this study is to explore the precise treatment in hepatobiliary cancer     patients and evaluate drug safety, progression free and overall survival. This trial study is     based on genetic tests, then therapeutic target drugs are administered according to the     genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications,     or translocations) may benefit from precise treatment which targets particular genetic     abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary     cancer patients better.   "
43591|NCT02715076|"     The purpose of this study is to determine:        1. the effect of ambient temperature on the rate of core temperature change from 1 to 3          hours after induction of anesthesia (linear phase of the hypothermia curve) in major          operations lasting at least a couple of hours and        2. whether the relationship between ambient temperature and rate of core temperature change          is different for patients who are or are not warmed with forced-air.   "
43592|NCT02715063|"     Several studies have shown relationship between exercise intensity and improvement     cardiometabolic health such as body composition, endothelial function, blood pressure and     blood lipids. It has been suggested that high intensity interval training and also strength     or resistance training generate positive effects on metabolic risk factors, nevertheless the     comparison between both types of training and their combination has not yet provided     conclusive evidence. Also, it has been shown that dietary restriction has similar or more     positive effects that exercise alone and the effect is greater when it is combined with     exercise. For these reasons, it is necessary to clarify which type of training, in     combination with a dietary restriction, is more effective to improve cardiometabolic health   "
43593|NCT02715050|"     The effects of phototherapy has been widely studied by some research groups. The     investigators know that there are positive results with light application to improve muscle     performance and delay fatigue. However, there are few studies showing its´ effects on     muscular training. Therefore, the aim of this study was to assess the effects of phototherapy     applied at different times during 12 weeks of strength training. For such, 48 volunteers,     healthy male, from 18 to 35 years old were recruited to perform a strength training protocol     for the anterior muscle of the thigh development. Volunteers performed the training protocol     three times a week for 12 weeks. There were assessed isometric peak torque in isokinetic     dynamometer, concentric peak torque, 1-repetition maximum test in the leg extension and leg     press machines and bilateral thigh perimetry.   "
43594|NCT02715037|"     Prospective, observational study of the microbiology of patients referred to a tertiary care     center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.   "
43595|NCT02715024|"     The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin     alone or in combination with solifenacin for the treatment in men with lower urinary tract     symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.   "
43596|NCT02715011|"     The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and     identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and     to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2.   "
43597|NCT02714998|"     The investigators aimed to investigate the effects of salpingectomy and Methotrexate     administration on ovarian reserve in ectopic pregnancy.   "
44483|NCT02703454|"     The study is designed as a prospective, multicenter, single-blind, randomized study to assess     the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the     treatment of symptomatic PAF. The subjects will be blinded to study treatment for the     duration of the study period.   "
43598|NCT02714985|"     Retrospective laboratory evaluation of the detection rate of CHIKV infection by real-time     Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on urine. Urine and serum samples     from patients with confirmed CHIKV infections from an endemic area (Aruba) and from ITM will     be analyzed. The results will be evaluated on a case-by-case basis: time since onset, patient     characteristics, severity of symptoms, serology results.      The positivity in-time of CHIKV RNA in urine will be evaluated in comparison with viremia.     Patients with suspected acute CHIKV infection will be asked (by written informed consent;     annex 1) to provide urine samples within 72 hours after onset of disease, followed by urine     samples on day 7, day 10, day 14 and three urine samples 3, 4 and 12 weeks after onset. They     will be asked to provide serum samples within 72 hours after onset of disease, followed by     serum samples on day 7, day 10, day 14. In total, twenty patients with an initial positive     result of CHIKV RT-PCR on serum will be included for follow-up. The number of urine samples     that will be tested is 140.   "
43599|NCT02714972|"     Objective: to gain experience in children and younger adolescents with in-home use of an     algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to     suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety,     and initial efficacy data      Study Design: randomized controlled trial, with randomization on a night level within subject     Patient Population: Youth 6.0 - <15 years old with type 1 diabetes treated with daily insulin     therapy for at least one year and an insulin infusion pump for at least 6 months who have     HbA1c < 10.0%.      Sample Size: 30 subjects      Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in     activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at     enrollment, following CGM and system assessment run-in phases, at start of clinical trial     phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use      Major Efficacy Outcomes:        -  Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.        -  Secondary: time spent in hypoglycemia (<70 mg/dl, 3.9 mmol/L) and time spent in          hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.      Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood     glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and     diabetic ketoacidosis   "
43600|NCT02714959|"     The purpose of this study is to determine whether low-dose IL-2 is effective in refractory     autoimmune encephalitis.   "
43601|NCT02714946|"     The purpose of this study is to prospectively compare percutaneous radiofrequency ablation     (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.   "
43602|NCT02714933|"     The aim of this study is to compare a new Magnetic Resonance Imaging (MRI)protocol, including     a new MRI sequence for visualization of lung parenchyma, to computed tomography as the gold     standard for the evaluation of thoracic region in children.   "
43628|NCT02714595|"     This study is designed to provide evidence of efficacy of S-649266 in the treatment of     serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.   "
43835|NCT02711891|"     This study evaluates topical loperamide 5% gel in reducing pain during repeat finger lancing     (finger stick) in healthy adults. Half of participants received 5% loperamide gel applied to     their fingertip prior to their second lance and the other half received the gel only.   "
43603|NCT02714920|"     Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The     therapeutic choice depends on the stage of the disease and the habits of the medical teams.     Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the     existing strategies has proven its superiority.      Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the     ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in     non-tumor tissues can also explain the toxicity of cancer treatments.      Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer a     good strategy for identifying biomarkers or indicators of treatment response. This study will     explore the capacity of a comprehensive functional approach that addresses several pathways,     based on the use of three innovative patented technologies, to classify the tumor response of     HNSCC patients to treatments according to their DNA Repair Enzyme Signature.      Our hypothesis is that taking into account various clinical parameters (e.g. patient and     tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature     would create patients' profiles and optimize their management.   "
43604|NCT02714907|"     The purpose of this study is to validate the quality of the ECG-signal acquired with the     Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial     fibrillation based on the ECG signal from the C3 monitor concurs with the current monitoring     methods used in clinical practice.   "
43605|NCT02714894|"     The purpose of this study is to investigate the relationship between glutamate and related     brain chemicals and treatment response to clozapine in patients with treatment-resistant     schizophrenia.   "
43606|NCT02714881|"     The objective of this study is to elucidate the relationship between inflammation and     lipoprotein atherogenicity, and to determine the relative contribution of inflammation and     lipids to CV risk in RA. The central hypothesis of this study is that inflammation and     lipoprotein atherogenicity is tightly linked such that both factors are important to assess     CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by a     consideration of routine lipids alone.   "
43607|NCT02714868|"     The purpose of this study is to determine the extent to which Project TEAM (Teens making     Environment and Activity Modifications) is an effective, socially valid, and feasible     intervention that prepares youth with developmental disabilities ages 14-21 to respond to     environmental barriers and increases participation in school, work, and the community.     Project TEAM is a manualized intervention co- facilitated by a disability advocate and a     licensed professional. The intervention includes eight group sessions and two experiential     learning field trips. In addition, young adults with disabilities serve as peer mentors on     field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes     are to: increase youths' knowledge of environmental factors and modification strategies;     reduce the impact of environmental barriers on participation; increase self-efficacy and     self-determination; and increase participation in a personal activity goal in the area of     education, employment, or community life. This project builds on a participatory action     research partnership with disability community stakeholders to address the following research     questions: (1) To what extent do youth with disabilities participating in Project TEAM     achieve intervention outcomes? (2) What are the characteristics of youth with disabilities     who most benefit from Project TEAM? (3) To what extent are goals, procedures, and outcomes of     Project TEAM important and acceptable (socially valid) to youth with disabilities?.   "
43608|NCT02714855|"     The present study will be conducted to assess the following research questions in real-life     conditions in France:      What are the patient and disease characteristics, comorbidities and treatment history in NVAF     patients initiating a new Anticoagulant (AC) treatment, according to treatment currently     available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles     different from one treatment pattern to another when initiating a new AC treatment?      What are the HCP's reasons for discontinuing the previous AC strategy for initiating and     choosing the newly initiated AC treatment in NVAF patients?      What are the conditions of newly-initiated apixaban prescriptions in NVAF patients:     prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?   "
43609|NCT02714842|"     This is a single-centre, open-label, randomised, three-arm crossover study with a fourth     fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the     study. This study is designed to correlate the gastrointestinal transit behaviour of     delayed-release diclofenac sodium tablets with their pharmacokinetic (PK) absorption     profiles.      The investigators will be looking at:        1. The behaviour of the tablets (when, where and how quickly they break up)        2. The gastric emptying time of the tablets (when they leave the stomach)        3. The gastrointestinal transit of the tablets (how long they take to travel through the          gut)        4. Blood levels of the drug (diclofenac)   "
43610|NCT02714829|"     A Randomized, Subject-Assessor Blind, Multi-center, Clinical Study of Injectable Ceramics     Bone Graft Substitute Containing rhBMP-2   "
43611|NCT02714816|"     MGT005 is a natural history study to collect longitudinal prospective data from patients with     Leber Congenital Amaurosis associated with defects in RPE65.   "
43612|NCT02714803|"     The aim of this study is to compare of different massage techniques plus conservative     aplications in low back pain treatment.   "
43613|NCT02714790|"     Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as     medullary expression of WT1 gene), performed at Baseline and during treatment according to     clinical practice. MRD results will be relate to treatment outcome and survival analysis     variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)   "
43614|NCT02714777|"     The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to     8 years old) receiving elective surgery, the impact of general anesthesia on autonomic     nervous system and their kinetics of early postoperative course (24 hours).   "
43615|NCT02714764|"     The purpose of this study is to define the natural history of Alexander Disease, a     leukodystrophy that causes neurological dysfunction. Investigators will obtain clinical     outcome assessments to measure how the disease affects a patient's gross motor, fine motor,     speech and language function, swallowing, and quality of life. The data obtained from this     study will be used for the design of future treatment trials.   "
43616|NCT02714751|"     Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can     develop adverse effects. Patient-ventilator asynchronies can be present from the beginning of     MV, it can be associated with poor outcome and it can develop clinical changes. The aim of     this study is to evaluate if the knowledge of the presence of asynchronies by the healthcare     team can help to reduce its incidence, improving outcomes of critically ill patients.      A prospective, single-center, before and after study will be conducted in the ICU of Hospital     de Sabadell. The study will have 2 phases: a first observational period where the incidence     of asynchronies will be assessed, and a second period where a daily information of the     presence of asynchronies to the healthcare team will be done with the aim to reduce the     incidence.      A continous record of asynchronies and clinical variables will be done during ICU stay.   "
43617|NCT02714738|"     The purpose of this study is to determine whether the incidence of tourniquet pain is     decreased if infraclavicular nerve block is administered, compared to axillary brachial     plexus block, for surgical interventions at the level or distal to the elbow.   "
43618|NCT02714725|"     This study is designed to explore the possible effects of dexmedetomidine infusion on     sublingual microcirculation in patients undergoing on-pump coronary artery bypass graft     surgery   "
43619|NCT02714712|"     The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins     (HDL) and one of entry factors for hepatitis C virus (HCV). The investigators aimed to     examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which     encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian     chronic hepatitis C (CHC) patients.   "
43620|NCT02714699|"     The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac     potassium on the pain scores during office hysteroscopy   "
43621|NCT02714686|"     In this experiment, the investigators will study the effect of a mass media family planning     campaign on contraception related behavior. The study takes place in Burkina Faso, a country     with an average of six children born to each woman, and a modern contraceptive prevalence     rate (mCPR) estimated at 15% in 2010 at the national level, as per the Demographic Health     Survey (DHS) 2010 report on Burkina Faso.      The aim of this study is to provide robust evidence on the efficiency and cost-effectiveness     of an intense three-year mass media campaign focused on family planning. The campaign will     diffuse messages about the financial and health benefits of family planning, and information     on the different types, sources, advantages, and disadvantages of different contraceptive     methods. The study will target women at the age of reproduction in rural areas of Burkina     Faso to measure the effect of the intervention on total and modern contraceptive prevalence     rates, perceptions of family planning, contraception-related behavior, and general gender     norms.      Burkina Faso is an ideal place to evaluate the impact of a radio campaign because a high     percentage of the rural population listens to local radio which is in the local language.     Radio station areas are distinct because they target very local languages and their reach is     limited by government decree, which allows for the implementation of a randomized control     trial.   "
43768|NCT02712762|"     This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host     Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival     redness and tear stability. Hence, the investigators expect to find an increased in     inflammatory cell population in GVHD conjunctival samples.   "
43622|NCT02714673|"     It is a multicenter, prospective, observational study of standard care. This study analyses     the care of patients on long term effective anticoagulation therapy (ADELC) during a primary     hip or knee arthroplasty.      The objectives of the study are to:        1. Identify clinical practices set up for patient care        2. Assess the type and the frequency of perioperative complications        3. Look for factors, related to patients or treatments, associated with the occurrence of          these complications.      The main objective is to estimate the risks, adjusted and not, of postoperative complications     associated to a long term anticoagulation by comparing patients under anticoagulation to a     control group of patients having the same interventions but who are not under     anticoagulation.   "
43623|NCT02714660|"     This mixed methods study aims to answer the question: What is the work of being a patient     with type 2 diabetes mellitus? .   "
43624|NCT02714647|"     The purpose of this study is to determine if priming attention prior to practicing a motor     task will have an effect on the ability to acquire and learn that motor task. The     investigators hypothesize that the acquisition and learning of a motor task will improve if     attention is primed prior to practicing that motor task when compared to a group who does not     receive the prime.   "
43625|NCT02714634|"     Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent     inflammatory arthritide, are non responders to the consensual 1st line of treatment :     methotrexate. In these patients, it is well demonstrated that the addition of other     immunomodulatory drug(s) often results in a significant improvement. However, the best option     regarding the drug(s) to add remains unclear. Rheumatologists are currently used to adding a     targeted biologic therapy, such as anti-TNFα, and more recently abatacept or tocilizumab.     Triple therapy using 3 conventional disease-modifying drugs (DMARDs),     methotrexate+salazopyrine+hydroxychloroquine could be an alternative option to biologics, all     the more as they have a more favorable safety profile and a much lower cost. Uncertainty     remains regarding the superiority of biologics on triple therapy in methotrexate insufficient     responders (IR). Investigators decided to address this issue by performing a randomized     controlled pragmatic trial.   "
43626|NCT02714621|"     The primary objective of this pilot study is to determine whether or not it is feasible to     use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an     acceptable safety profile when conventional treatment options are not available. The ultimate     goal is to be able not only to offer a viable method of symptom palliation in patients with     recurrent pelvic tumours and improve their quality of life; but also to control tumour growth     and extend life in a group of relatively young patients with isolated local recurrence.   "
43627|NCT02714608|"     Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is     being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in     patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency)     and explore the optimal dosage   "
43629|NCT02714582|"     Hospitals face the challenge to continually improve their quality of care. In order to     achieve this goal, they have to focus on both improving clinical practice and increasing the     involvement of patients in the healthcare process. Both factors are equally important to     quality of care. The World Health Organization highlights the role that patients and their     family could play in the improvement of healthcare. Active patient participation reduces     communication errors, increases patient empowerment and is associated with positive health     and psychosocial outcomes. A possible strategy to improve patient participation through     communication can be bedside shift report (BSR).      Bedside shift report is a process where shift-to-shift report between nurses is, if approved     by the patient, executed at the patient's bedside in order to improve the patient's     involvement. Bedside shift report has the potential to result in more patient satisfaction,     better clinical outcomes, improvement of health education and enhanced team coherence.     Preliminary research indicates that BSR decreases safety incidents and adverse events and     readmissions, positively influences staff satisfaction, offers beneficial financial effects     by reducing nurses' overtime, and allows direct patient care to start earlier.      Despite of these effects, rigorous and large-scale scientific research on this topic is     lacking. Currently, the available evidence is scarce and mostly consists of single case or     small-scale studies. Longitudinal results on effectiveness and sustainability of BSR are also     unknown or inconclusive. There is a need for an increased number of controlled studies to     evaluate the impact of BSR on patient, staff and economic outcomes and its longitudinal     results.      The aim of this study is four-folded:        1. The development and fine-tuning of a BSR-intervention and implementation protocol by          using diagnostic interviews, co-design, and pilot studies.        2. A quantitative evaluation of BSR in comparison with care as usual on patient-related,          clinical, and nurse-related outcomes.        3. A qualitative evaluation of the feasibility, appropriateness and meaningfulness of BSR          as a method to improve communication and patient participation with a particular          interest in the experience of benefits and disadvantages by healthcare professionals and          patients.        4. A process evaluation of BSR to determine the intervention fidelity and to assess the          evolution of BSR over the period of the study (e.g. adaptations, consistent practice).      The study design was based on the Medical Research Council-framework for developing and     evaluating complex interventions. Power calculation indicates a minimum of 5 experimental     wards with 35 patients should be included in the study. The hospital, the specialization of     the ward and the nurse-patient ratio will be used for the matched controlled assignment.   "
43630|NCT02714569|"     The purpose of this two-part study is to evaluate the safety and tolerability of the study     drug known as LY3202328 in healthy overweight participants in Part A, and those with     dyslipidemia (abnormal blood fats) in Part B.   "
43631|NCT02714556|"     Pregnancy is associated with physiological changes affecting the cardiorespiratory system as     a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of     this prospective observational study is to examine the perioperative changes in ventilation     inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath     washout and forced oscillation techniques.   "
43642|NCT02714413|"     Individuals in the United States now consume a substantial proportion of their total energy     as added sugars. The consumption of caloric sweeteners has been steadily increasing over the     last four decades. The potential health consequences of this practice have been subject to     considerable debate. In addition to weight gain, higher consumption of sugar-sweetened     beverages is associated with development of metabolic syndrome and type 2 diabetes. These     findings support the current dietary guidelines that encourage consumers to limit their     intake of added sugars. There is a need for a sugar substitute that is safe, palatable and     has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar is     possibly D-allulose also referred to in the literature as D-psicose. The present proposal is     to address the efficacy of D-allulose in reducing postprandial blood glucose level in a     random sample of Caucasian and African American population. Specifically the effect of     D-allulose ingestion on the glucose and insulin response to a standardized oral glucose load     will be studied.   "
43632|NCT02714543|"     Oral submucous fibrosis is a chronic, insidious disease caused by arecanut use and is     associated with both significant morbidity (including burning sensation and reduced oral     opening) and an increased risk of malignancy. Treatment of Oral SubMucous Fibrosis has     largely been symptomatic and is associated with high recurrence rate. Aloevera has     immunomodulatory, anti-inflammatory, wound healing, antioxidant and antineoplastic     activities. All such properties of Aloevera suggest the possibility of its use in the     management of oral submucous fibrosis.      In the present study, 74 patients of Oral SubMucous Fibrosis were randomly divided into 2     groups (Group A & B). Group A patients were instructed to drink 30ml of aloe vera juice twice     daily before food and to apply 5mg (approx 1 scoop) of aloe vera gel over the lesion 3-4     times daily for 3 months. Group B patients were given intralesional injections of 1.5ml     Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also     prescribed SM Fibro (Alpha lipoic acid 50mg, Beta-carotene 10mg, Elemental copper 1mg,     Elemental selenium 75mcg, Lycopene 5mg, Vitamin E 10 IU, Zinc sulphate 27.45mg in form of the     capsule) for 3 months. Patients were assessed for burning sensation, interincisal     mouthopening, cheek flexibility and tongue protrusion at an interval of 1, 2 and 3 months.   "
43633|NCT02714530|"     The purpose of this study is to determine if erlotinib given orally along with concurrent     palliative irradiation to lung cancer improves local control compared to those treated with     radiotherapy alone.   "
43634|NCT02714517|"     The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in     patients affected by neuropathy.   "
43635|NCT02714504|"     Patients admitted for autologous or allogeneic hematopoietic cell transplantation,     induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid     leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with     dermatologic examination. In the presence of any skin lesion in the extremities, direct exam     and fungal culture will be performed. If these exams indicate the presence of Fusarium     species, patients will receive anti-mold azole prophylaxis   "
43636|NCT02714491|"     Aim of the study is to define if the auditory stimulation during stepping verticalization     sessions with Erigo is able to modify the cerebral electric activity or improve     consciousness in patients affected by vegetative state or minimally conscious state.   "
43637|NCT02714478|"     The purpose of the study is to evaluate the effect of Equistasi device on quantitative and     qualitative gait characteristics in patients affected by hemiparesis.   "
43638|NCT02714465|"     Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic     resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery     (GKS) by treatment with hyperbaric oxygen therapy (HBO)   "
43647|NCT02714348|"     Helminth infection is associated with low vaccine immunogenicity. Pregnant women are     particularly sensitive to helminth infection.      Since most vaccines are given shortly after birth, an effect of parasites on infant     immunogenicity is of particular concern. Therefore, within this study the investigators aim     to investigate if maternal infection influences vaccine immunogenicity in the newborn.   "
43639|NCT02714452|"     The overall aim of this study is to evaluate the effects, meaning and significance of a     person-centred and thriving promoting model for residential aged care in Australia, Norway     and Sweden. More specifically, the following research questions will be explored:        1. Can a person-centred and thriving promoting care model increase residents' thriving, and          have a positive impact on residents' perception of the caring environment?        2. Can a person-centred and thriving promoting care model increase relatives' satisfaction          with care, and have a positive impact on their experience of visiting their relative,          and perception of the caring environment?        3. Can a person-centred and thriving promoting care model increase staff's job          satisfaction, decrease stress of conscience, and have a positive impact on their          perception of the caring environment and person-centred care?        4. What meaning and significance do relatives and staff ascribe to the intervention? The          study is designed as a multi-centre, controlled group before-after design with          participating sites in Victoria (Australia), Oslo (Norway) and Västerbotten (Sweden).          Two residential aged care facilities at each site will be allocated to either          intervention or control, in total three intervention and three control facilities          divided over the three sites.      Care staff at the intervention facilities will participate in a 12-month education on how to     integrate aspects of person-centredness, thriving and a caring environment into daily care     practice. Participating staff will work together with their colleagues and members from the     research group to create a reflective and creative learning environment that builds on and     develops the staff members' clinical experience and skills, and combines it with theoretical     and research-based knowledge.      At the control facilities, care staff will participate in a 2-hour lecture on the theoretical     and philosophical foundations of person-centredness, thriving and a caring environment, and     then continue with practice without further involvement from the research team.      Evaluation data will be collected by study specific questionnaires before the education     starts, immediately after the education and at a 6-month follow-up. In addition, focus group     interviews and individual interviews will be conducted with a selection of staff members and     relatives at the intervention facilities to explore meaning and significance of the     intervention.   "
43640|NCT02714439|"     The purpose of this study is to evaluate a different type of medical equipment called     High-Resolution Microendoscope (HRME) for the diagnosis of cervical pre-cancerous lesions     and cervical cancer. The investigators want to compare patients' clinical findings using the     current equipment used in clinic with the clinical findings using new equipment we are     testing on this research project. If the new equipment is proven to give comparable findings     with current equipment being used, doctors might be able to offer a diagnosis and treat     cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to     come back before women would receive the indicated treatment. Study subjects are being asked     to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP     smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to     have a colposcopic examination to determine the reason for abnormal results and receive     treatment.   "
43641|NCT02714426|"     Attentional control, or individuals' ability to choose which stimuli in the environment they     attend to and which they ignore, declines with older age. Studies from the past two decades     suggest that mindfulness meditative practice, such as a standardized mindfulness based stress     reduction programs, may increase the efficiency of attention networks.To date, the majority     of studies that have related mindfulness meditation practice to attentional control have been     based on retrospective self-reported mindfulness or cross-sectional measurement in     experienced meditators. More recent experimental studies using pre-post training designs have     shown that meditation-naïve individuals can experience attentional improvement with     mindfulness intervention. This study seeks to elucidate the time course and process by which     such attentional improvements might be achieved.      This research study investigates change in attentional control as participants progress     through an 8-week mindfulness-inspired training (MIT) intervention, and has two specific     aims: 1) to determine the time course of change in attentional components such as cognitive     control and sustained attention as a consequence of MIT; attention will be measured weekly     for 3 weeks before, 3 weeks after, and during 8 weeks of MIT. 2) To investigate the extent to     which change in attentional performance is coupled/correlated with markers of emotion     regulation, perceived mindfulness, and perceived mind wandering.   "
43769|NCT02712749|"     The Investigators verify the effectiveness of Binaural Beats as premedication instrument in     elderly patients submitted to major surgery, in order to reduce the preoperative stress and     possibly limit the use of sedatives and anti-anxiety medications.   "
43643|NCT02714400|"     The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low     arousal threshold may wake up too early during a respiratory event, before upper airway     muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the     respiratory arousal threshold could potentially improve the quality of sleep and sleep     disordered breathing. Agents that raise arousal threshold are therefore likely to benefit     some patients with OSA. The overall goal of this project is to determine the importance of     the arousal threshold in OSA, determine which patients might benefit from a raised arousal     threshold, and test this hypothesis by using pharmacological manipulation of the arousal     threshold to achieve this goal.   "
43644|NCT02714387|"     The purpose of this observational epidemiological study is to investigate the management and     the complications associated with Non Traumatic Neuro-Vascular Diseases. Data will be     analysed to answer pre-defined scientific projects and to improve management of these     conditions.   "
43645|NCT02714374|"     The purpose of this study is to evaluate the safety of the investigational product GL-ONC1.     GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer     drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as     smallpox vaccine in millions of people worldwide.   "
43646|NCT02714361|"     Iron is one of the most vital elements in humans as it plays a role in physiological     functions such as transferring and storing oxygen, transporting electrons and catalysing     numerous reactions, from oxidative metabolism to cellular proliferation. Iron deficiency can     be attributed to poor absorption that leads to insufficient iron to meet body requirements.     Oral iron supplements have been extensively used to treat iron deficiency and iron deficiency     anaemia. However, the use of iron compounds in fortifying foods is one of the best practical     approach to combat iron deficiency, while improving diet and food pattern involves long-term     goal which can be challenging. Vitamin D has recently been shown to affect hepcidin levels,     which in turn has effects on iron status but there are a limited number of studies     investigating the hepcidin profile in humans following iron supplementation, and few data are     available, especially in humans, despite its role as a primary iron absorption and     homeostasis regulator. Although several studies have been carried out using iron fortified     products, there is limited data on the potential effect of vitamin D on iron metabolism     amongst iron deficient women in particular. Therefore, the present study aims to investigate     the effect of vitamin D3 supplementation (1500 IU) consumed with iron fortified breakfast     cereals on haematological indicators and hepcidin response in iron deficient women.   "
43685|NCT02713854|"     To determine the predictive value of attachment rate of human embryonic stem cells     (hESC)-derived trophoblast spheroids (BAP-EB, embryo surrogate) onto endometrial epithelial     cells (EEC) on success of IVF treatment and to use the model to identify EEC surface     biomarkers for endometrial receptivity.   "
43648|NCT02714335|"     Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian     especially Southeast Asian, it would be great interests to investigate the potential     polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Meanwhile,     it is also interesting to study the expression of Preferentially Expressed Antigen In     Melanoma(PRAME) and Epidermal growth factor receptor (EGFR) mutation status as well as to     find out significant factors which may affect their expression such as smoking status,     histological types, tumour size and stages in Taiwan.   "
43649|NCT02714322|"     To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with     moderate-to-severe chronic plaque psoriasis   "
43650|NCT02714309|"     Consuming whey protein may have beneficial effects on health, principally by having an impact     on blood glucose metabolism, but also by affecting appetite. The purpose of this project is     to investigate the effect of consuming whey protein preload prior to breakfast, following a     bout of low/moderate intensity exercise (brisk walking), on glucose and lipids in the blood     as well as on appetite.      It is hypothesised that the consumption of whey protein before a meal after prior     low/moderate intensity exercise may positively affect postprandial handling as well as     appetite sensations and consequently reduce intake at a subsequent meal.   "
43651|NCT02714296|"     This study is an open, prospective, comparative diagnostic studies aimed at improving the     colonoscopy results, by optimizing the way of preparation for endoscopy   "
43652|NCT02714283|"     The purpose of this study is to provide patients and their physicians with greater     understanding of the risks and benefits of commonly used therapies for treatment of non-CF     bronchiectasis   "
43653|NCT02714270|"     Paperless partograph is a technique used for monitoring the progress of labor before     delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.      The study will be carried out to find out the effectiveness of paperless partograph in     management of labor and its effect on maternal and neonatal outcomes   "
43654|NCT02714257|"     The investigators propose a 36-month multi-center randomized effectiveness trial to compare     the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching     (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients     with a previous fragility fracture (FF).      The investigators will also examine the impact of the intervention on several secondary     outcomes like: loneliness, physical function, and bone strength. The investigators will do     this by following a Pragmatic trial design: 1) limiting exclusions to increase     representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting     measures to those practicable for use in usual care.   "
43677|NCT02713958|"     This experimental research aims to examine the efficacy of Telerehabilitation treatment using     a computerized system (MediTouch) in improving the upper limb function post elbow fractures.     24 participants aged 18-80 who are post surgery to fixate elbow fractures or arthrolysis of     the elbow will be invited to participate in the study. The subjects will be matched into two     groups according to age and fracture type to study and control groups. Both groups will be     treated for a month in ambulatory clinic in the hospital and will do self-practice at home     according to a intervention protocol. The subjects in the experimental group will receive two     treatments in Telerehabilitation and one treatment in the clinic weekly, and the subjects in     the control group will receive three treatments in the clinic every week. Activity daily     living (ADL), Range of Motion, Hand strength disability and pain will be assessed before and     after the intervention in order to asse the efficacy of the intervention.   "
43655|NCT02714244|"     Diastolic function may be evaluated by different measurements on transesophageal     echocardiography (TEE). They include mitral inflow velocities obtained by pulsed-wave doppler     (PW) : peak early diastolic velocity (E) and late diastolic velocity (A). Mitral annulus     velocities, early diastolic (e') and late diastolic (a') are obtained by tissue doppler     imaging (TDI). The ratio E/e' reflects left ventricular filling pressure and, as such, might     be a predictor of fluid responsiveness.      The aim of this study is to evaluate the predictive value of the mitral valve E/e' ratio for     fluid responsiveness among patients undergoing coronary bypass graft surgery. Fluid     responsiveness being defined as an increase in stroke volume of ≥ 15%.      After induction of anesthesia, patients will have their diastolic function evaluated by means     of E/e' and other measures. They will then be administered an intravenous bolus of 500 mL of     Lactate Ringer® along with passive leg raising (PLR). Stroke volume and fluid responsiveness     will be assessed by the thermodilution method (Swan-Ganz catheter) and the FloTrac® device.     Fluid responders will be compared to non-responders to evaluate the relationship between E/e'     ratio and fluid responsiveness.   "
43656|NCT02714231|"     The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral     hyoscine butyl bromide during intrauterine device insertion.   "
43657|NCT02714218|"     The purpose of this study is to evaluate two different dose combinations of nivolumab and     ipilimumab in the treatment of melanoma.   "
43658|NCT02714205|"     A randomized, double-blinded, placebo-controlled trial of uninterrupted transdermal nitrate     therapy in 140 peri- or postmenopausal women who have frequent hot flashes. Women will be     randomly assigned to uninterrupted use of transdermal nitrate therapy (participant directed     dose-escalation of 0.2 to 0.6 mg/hr) or identical-appearing placebo patches for 12 weeks.   "
43659|NCT02714192|"     The purpose of the study was to determine if administration of an exercise stress test within     the first ten days after a sports related concussion would delay or otherwise interfere with     recovery.   "
43660|NCT02714179|"     The investigators designed a prospective randomized study to investigate the efficacy of     intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores,     patient satisfaction, total morphine consumption and the incidence of morphine‑related side     effects in patients undergoing cesarean section.   "
43661|NCT02714166|"     To evaluate the human eye irritation potential of one test sunscreen formulation.   "
43662|NCT02714153|"     To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within     the Superior Vena Cava in lead extraction patients.   "
43686|NCT02713841|"     The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled     insulin administration with 3 different inhalation regimens and with subcutaneous insulin     administration.   "
43663|NCT02714140|"     Despite worldwide efforts to promote HIV Counseling and Testing (HCT), rates of testing     remain low. Understanding how high risk groups decide to test and adapting available testing     options to their preferences has the potential to broadly improve HCT uptake and     cost-effectiveness. This study proposes to use a Discrete Choice Experiment, a survey method     increasingly used by health economists for the design of patient-centered health care     options, to rigorously quantify HIV testing preferences among two high-risk populations,     identify their preferred testing options, and evaluate, in a pragmatic randomized controlled     trial (RCT), the effect of a preference-based HIV counseling and testing (PB-HCT)     intervention on testing uptake. At a time of heightened focus on health preferences research     and patient-centered care, this study evaluates the critical link between preference-based     intervention design and efficacy. If the RCT indicates that PB-HCT increases testing rates,     the testing options evaluated in this R01 can be offered to high-risk populations in the     study area, and the preference elicitation method and tools can be used to inform the design     of testing options that better match the preferences of other high-risk populations and in     other settings.   "
43664|NCT02714127|"     The aim of the study is to develop robust analytical protocols for first-void urine sample     preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for     improved diagnosis of cervical (pre)cancer lesions.   "
43665|NCT02714114|"     The aim of the study is to develop robust analytical protocols for first-void urine sample     preparation and antibody assays to monitor natural and/or vaccine induced immunity against     HPV (Human Papillomavirus).   "
43666|NCT02714101|"     Children with Autism Spectrum Disorder have difficulty engaging in activities. This study     examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4     to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline     assessments, 9 to 12 intervention sessions, and 4 follow-up sessions.   "
43667|NCT02714088|"     High-intensity interval training (HIT) has been demonstrated to be an effective strategy to     improve markers of health and fitness across a wide range of healthy and clinical     populations. Currently however, there is only limited evidence which has examined the     effectiveness of HIT in older adults (>50 years). HIT is an appealing strategy in this group     as it has the potential to impact both cardiorespiratory and muscular fitness, which both     play an important role in maintaining functional fitness and quality of life in a     time-efficient manner. Developing an understanding of novel strategies for delivering this     type of exercise training may ultimately provide a viable alternative to traditional modes of     exercise training for a broader range of participants. As such, the purpose of this study is     to evaluate the effects of a novel, high-intensity interval training exercise protocol to     improve physical fitness in adults aged over 50 years. This research also aims to evaluate if     this type of training intervention is feasible in this population, through analysis of     adherence and intervention fidelity.   "
43678|NCT02713945|"     This study evaluate the efficacy of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-COA) reductase     inhibitors, also known as statins in the treatment of growth and skeletal abnormalities in     children with Noonan syndrome. Half of patients will receive simvastatin while the other half     will receive a placebo.   "
43679|NCT02713932|"     The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a     prospective Italian registry including several centers performing TAVI, collecting baseline,     procedural and outcome data.   "
43770|NCT02712736|"     The purpose of this study is to assess the healthcare-related quality of life (HRQOL), the     impact of risk of liver transplant and risk of malignancy on HRQOL, and the complementary and     alternative medicine use in patients with PSC.   "
43668|NCT02714075|"     Rice can only be fortified with ferric pyrophosphate (FePP), which is of low bioavailability     in human subjects. Compounds such as citric acid/trisodium citrate (CA/TSC) or sodium     ethylene-diamine tetraacetic-acid (EDTA) could serve as absorption enhancers. Recent findings     from single meal studies indicate CA/TSC to have an enhancing effect on iron absorption from     FePP-fortified rice. In contrast, ZnO has been suggested to have detrimental effects.     Furthermore, in vitro findings suggest an increased iron solubility from iron and     EDTA-co-fortified rice - but the bioavailability in humans remains to be investigated. These     effects should thus be investigated in 'real-life' conditions, when fortified rice is     implemented in a complete diet administered throughout several days in a target population     for a rice fortification program.      Objective: To assess iron absorption from the diet from different iron fortified rice     formulations in iron deficient anaemic children.      The investigators aim to conduct an iron absorption study in 30 Ghanaian school-age children     investigating different fortification approaches in a multiple meal randomized, cross over     study.   "
43669|NCT02714062|"     The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in     obese adolescents.   "
43670|NCT02714049|"     Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study     medication alone vs. study medication and sex therapy for 12 additional weeks.   "
43671|NCT02714036|"     This is a multi-center, open-label study of MN-166 (ibudilast) in subjects with ALS. To be     eligible subjects must meet the El Escorial criteria of possible, laboratory-supported     probable, probable, or definite criteria for a diagnosis of ALS. Safety, tolerability, blood,     neuro-imaging biomarkers, and clinical outcomes will be collected on all subjects. Subjects     will receive study drug for 36 weeks.      The study will consist of a Screening Phase (up to 6 weeks), an Open-Label Treatment Phase     (36 weeks) and a Off-Treatment Follow-up Phase (4 Weeks).      Number of Subjects (Planned):      Approximately 35 subjects are planned to be screened with the goal of enrolling 25 subjects.   "
43672|NCT02714023|"     Patients who are diagnosed with acute appendicitis consented and then randomized into two     arms of the trial. In one arm, patients receive irrigation of the abdomen during surgery with     normal saline, or salt water. In the other arm, patients receive irrigation of the abdomen     during surgery with sterile water. Sometimes patients receive no irrigation if none is     determined to be needed at the time of operation by the surgeon. We then followed patients     after surgery for 30 days. The hypothesis of this study was that the use of sterile water as     irrigation fluid during surgery in patients who have acute appendicitis will decrease the     chance of a post-operative abscess or infection.   "
43673|NCT02714010|"     This is a multi-center phase III randomized controlled study, designing to access whether the     efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer     (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain     radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary     outcomes included overall survival (OS), objective response rate (ORR), evaluation of     cognitive function, quality of life (QoL) and adverse events.   "
43674|NCT02713997|"     Patients with severe chronic pancreatitis may be candidates to have their pancreas removed     and their islets transplanted into the liver to reduce the risk of diabetes mellitus, a     procedure called total pancreatectomy with islet autotransplant (TPIAT). However, over half     of patients who have a TPIAT will need to remain on some supplemental insulin life-long after     the procedure. We will study therapies that may reduce damage to transplanted islets, and     thereby improve long-term outcomes.      Two promising anti-inflammatory therapies are available to protect islets from damage at the     time of transplant: (1) the Tumor Necrosis Factor (TNF)-alpha inhibitor etanercept and (2)     the serine protease inhibitor alpha-1 antitrypsin. Both agents are commercially available for     clinical trials. Proof-of-principle for etanercept has been demonstrated in type 1 diabetic     allotransplant recipients, in whom a 10 day course of etanercept early post-transplant     significantly improved long-term insulin independence, due to better survival of the     transplanted beta cell mass in the engraftment period. Alpha-1 antitrypsin (A1AT) reduces     inflammatory cytokines, protects against cytokine-induced beta cell apoptosis, and prolongs     islet graft survival in mice and intraportal IAT non-human primates.      This initial 3-arm drug-treatment clinical trial will investigate the use of Etanercept and     A1AT to improve IAT function at 90 days and 1 and 2 years post-TPIAT compared to standard     care. Forty-five patients undergoing TPIAT will be randomized 1:1:1 to receive either: 1)     etanercept (50 mg on day 0; 25 mg on days 3, 7, 10, 14, and 21), 2) alpha-1 antitrypsin (90     mg/kg IV days -1, +3, 7, 14, 21, 28) or 3) standard care. Patients will have mechanistic     assessments drawn in the early post-operative period including inflammatory cytokines and     chemokines and measures of beta cell loss. Metabolic testing will occur at 90, 365, and 730     days post-TPIAT, including mixed meal tolerance testing, IV glucose tolerance testing, and     glucose-potentiated arginine-induced insulin secretion (GPAIS).   "
43675|NCT02713984|"     Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid     tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers.     Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency     targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its     adverse effects including cytokine storm response and any other adverse effects. In addition,     CAR-T cells persistence, tumor elimination and disease status after treatment will be     evaluated.   "
43676|NCT02713971|"     Background: In this study, a new biofeedback system for balance and gait rehabilitation     (Gamepad) was developed. The system, based on wearable inertial sensors, provides users with     real-time visual and acoustic feedback about their movement during functional tasks. Gamepad     was applied on subjects with Parkinson's disease (PD) in a pilot randomized controlled trial     to investigate its feasibility and efficacy versus conventional physiotherapy. The     investigators hypothesized that Gamepad system can be easily applied in clinical settings and     that biofeedback training with Gamepad provides larger improvements of balance and gait in PD     subjects, respect to conventional physiotherapy.      Methods: Forty-two PD patients underwent a 20-session training for balance and gait (45     minutes per session, 3 sessions per week). Participants were randomized into Gamepad Group     (biofeedback rehabilitation with Gamepad system), and Control Group (conventional     physiotherapy). Clinical and instrumental assessments were performed by a blind examiner     pre-, post-intervention and at 1-month follow-up.   "
43713|NCT02713490|"     This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately     300 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine     HCl (10-15 mg).   "
43771|NCT02712723|"     The purpose of this study is to determine if ribociclib in combination with letrozole for 24     weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative     Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with     letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.   "
43680|NCT02713919|"     Background: Up to 64% of cancer patients experience pain, and as many as 40% of patients with     pain do not receive adequate pain management. And while potential to reduce pain has been     shown in several interventions that support patients' self-management, effects have been     moderate. Purpose: This multicenter mixed methods study primarily aims to evaluate the     efficacy of the adapted German PRO-SELF© Plus Pain Control Program (PCP) on pain intensity,     to explore the intervention's effect on associated symptoms and other patient and family     caregiver (FC) outcomes, and to explore patients' and FCs' experiences with cancer pain     management.      Methods: A nested concurrent mixed methods design will be used for this multi-center study,     that is, a randomized controlled trial (RCT) will be combined with a qualitative substudy.     Participants will be randomly assigned to a 6-week intervention or usual care group; outcomes     will be evaluated at 6 weeks post-randomization. The primary outcome will be pain intensity.     A total sample of 210 patients with cancer pain and approximately 105 FCs will be recruited     from the oncology outpatient clinics of the University Hospitals Basel, Zurich and Bern. The     intervention is designed to implement structured and tailored components (information,     skill-building, nurse coaching) and aims at improving patients' pain self-management. Data     analysis will follow an intent-to-treat strategy and generalized mixed models will be used.     For the qualitative substudy, 60 patients and FCs of both groups will be interviewed. Data     will be systematically summarized.   "
43681|NCT02713906|"     The purpose of this study is to assess the positioning of customized guides designed from     patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total     knee arthroplasty.   "
43682|NCT02713893|"     The primary objective of the study is to evaluate local tolerability of the new     Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone     products and placebo. Pharmacokinetics of the study products after single and repeated     applications once a day for 15 days, safety of the investigational products and comfort of     use will also be evaluated as secondary objectives.   "
43683|NCT02713880|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of     Transthyretin-Related Familial Amyloidotic Polyneuropathy from plasma. Testing for clinical     robustness, specificity and long-term stability of the biomarker.   "
43684|NCT02713867|"     The primary objective of this study is to show that PFS (progress-free survival) rate at 6     months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks is non-inferior     to nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC     (non-Sq and Sq).   "
43687|NCT02713828|"     Patients with advanced or metastatic, gpNMB-expressing Squamous Cell Carcinoma (SCC) of the     lung who have failed a prior platinum-based chemotherapy regimen will receive glembatumumab     vedotin.      Glembatumumab vedotin consists of an antibody (a type of human protein) attached to a drug     called Monomethyl Auristatin E (MMAE) that can kill cancer cells. Glembatumumab vedotin is     intended to work by specifically directing the drug to the cancer cell. It attaches to a     molecule on the cancer cell called gpNMB, and then releases the MMAE inside the tumor cell,     which in turn causes the cell to die.      The purpose of this study is to see whether glembatumumab vedotin is effective in treating     people who have advanced or metastatic squamous cell lung cancer that contains gpNMB, to     examine how the body handles the drug and the side effects associated with glembatumumab     vedotin.   "
43688|NCT02713815|"     The motivational-cognitive psychotherapy and repetitive transcranial magnetic stimulation     (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.   "
43689|NCT02713802|"     Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single     doses of Cudafol(R) and Diprivan(R) in healthy subjects.   "
43690|NCT02713789|"     To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg     and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction     longer than six months that is attributable to an underlying, stable medical condition.   "
43691|NCT02713776|"     During rectal or complex digestive surgery with multiple digestive resections and     anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated     that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year     with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not     controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients     to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte     abnormalities and acute renal failure. This risk implies parenteral correction which may     extend hospital stay and delay home return.      Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive     secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not     routinely used for the treatment of patients with high-output enterostomy and their efficacy     in the indication (off-label) was only tested in small case series. Pasireotide (SOM230,     SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for     whom surgery is not an option or for whom surgery has failed.      As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual     medical treatment associated with an oral fluid restriction has never been demonstrated     before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled     trial evaluating its impact on reduction of the effluent volume.   "
43772|NCT02712710|"     The purpose of this study is to investigate the effect of functional knee brace in the     subjects with medial compartment knee OA.   "
43773|NCT02712697|"     The present study was designed to identify the efficacy and safety of Integrative Medicine by     joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy.     Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and     Metabolomics.   "
43692|NCT02713763|"     The therapeutic goals in the management of pancreatic neuroendocrine tumors (pNET) are the     control of symptoms and tumor growth control in order to improve patient survival.      In recent years, data from two phase III studies with targeted therapies, sunitinib and     everolimus, have broadened the possibilities for treatment of patients with neuroendocrine     tumors of the pancreas.      Unfortunately, patients progress and development of new active drugs and evaluating the best     treatment approach is decisive.      Given the lack of data comparing the activity of different treatment strategies, final     decisions are based on medical experience and consensus of experts. In this context,     different questions are still unanswered, as which is the best sequence of treatment and if     all patients can benefit from all available drugs.      Neuroendocrine pancreatic tumors are highly vascularized tumors in which cells may be     dependent on this pathway for growth throughout the entire history of the tumor and in which     inhibition of this pathway is crucial. On the other hand, this aspect has not been endorsed     by the population of patients with pNET who have previously failed treatment with sunitinib.      In this scenario we will assess retreatment with sunitinib to evaluate the activity of this     drug in the context of therapeutic rescue in patients with metastatic pNET.   "
43693|NCT02713750|"     This study will create a model of reproductive health services for HIV-positive female     adolescents in Asia.   "
43694|NCT02713737|"     The investigators hypothesized that heated humidified high-flow nasal cannula oxygen(HFNC)     along with high quality of sleep, in comparison with noninvasive positive pressure     ventilation (NIV), could reduce the release of inflammatory marker C-reactive protein(CRP),     which as independent predictor of atrial fibrillation（AF）, further lower the incidence of     new-onset AF following coronary artery bypass grafting(CABG).   "
43695|NCT02713724|"     This study investigates whether an individualized exercise program, including a personal     trainer, can improve cardiovascular status quantified with ultrasound to assess coronary flow     reserve and other non-invasive techniques. The subjects in the study will be divided into two     groups; one group will have a personalized exercise- and nutrition program and the other     group will have acess to a gym membership, but no personal trainer.   "
43696|NCT02713711|"     The purpose of this study is to compare the effectiveness of artificial balneotherapy (AB),     phototherapy (PT) and artificial balneophototherapy (BPT) in the treatment of plaque     psoriasis, evaluating the plaque area, alteration of skin pigmentation, Psoriasis Area and     Severity Index (PASI) score determination and quality-of-life assessment by Short Form 36     Health Survey (SF-36) and Psoriasis Disability Index (PDI) scores during the month of     treatment. Methods: Experimental study, prospective, randomized, single-blind. 14 subjects     participated from the city of Talca, Chile medically diagnosed with psoriasis, more than one     plaque in the skin without topical treatment voluntarily. All subjects completed the study     that consisted of 12 sessions.   "
43697|NCT02713698|"     The main purpose of this research is to develop a population pharmacokinetic and     pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia,     using BIS as a pharmacodynamic endpoint.      A covariate analysis will be performed in order to account for variability in pharmacokinetic     and pharmacodynamic parameters. The influence of age and obesity on propofol pharmacokinetic     parameters will be particularly addressed.   "
43698|NCT02713685|"     60 ASA grades- I, II or III patients, undergoing lower limb surgeries, will be randomly     allocated in 2 groups of 30 patients each. In group S- subarachnoid block with 0.5%     Bupivacaine (hyperbaric) 2.5ml will be given in lateral position and group B received femoral     3 in 1 block in supine position(with landmark technique) with 20 ml of 0.25% of Bupivacaine,     followed by Sciatic block in lateral position with 20 ml of 0.25% Bupivacaine. Onset and     duration of sensory and motor block, time of first analgesic requirement, VAS Scores at end     of block and surgery, hemodynamic effects, patients' and surgeon's satisfaction will be     evaluated.   "
43699|NCT02713672|"     The cytochrome P450 (CYP) is a group of metabolic enzymes, from which the 2D6 and CYP2C19     polymorphisms are specifically related to the metabolism of psychiatric drugs. The prevalence     of CYP2D6 and CYP2C19 polymorphisms differs among ethnicities. Depending on the number of     functional alleles, individuals are classified as Poor Metabolizer (PM), Intermediate     Metabolizer (IM), Extensive Metabolizer (EM) or Ultra Rapid Metabolizer (UM).      Research has suggested that PM genotype is a predisposing factor for antipsychotic-induced     side-effects. Besides susceptibility for side effects and lower quality of life, also, a     relationship between phenotype and costs of care has been shown.      Guidelines recommend that PM, IM and UM genotypes need dose adjustment, to optimize the     effectiveness of the drug and/or to reduce side effects. No research has been done to     investigate cost-effectiveness of implementation of genotyping in daily clinical psychiatric     practice.      This study investigates the effectiveness of implementation of CYP2D6 and CYP2C19 genotyping     in psychiatric patients in Curacao and analyzes the costs of genotyping versus health     benefits.   "
43700|NCT02713659|"     This study is testing the effects of early literacy promotion compared to standard literacy     promotion at The Children's Hospital of Philadelphia. Eligible participants and their     families will be consented and randomly assigned into either a standard literacy program or     an early literacy program. Standard literacy will consist of the receipt of books and reading     promotion beginning at 6 months of age, while early literacy will consist of the receipt of     books and reading promotion beginning in the newborn period. In both groups, participants     will receive weekly text messages until the child is 6 months old (the text messages will     either about reading or safety) and have follow-up study visits at 6, 12, 18, and 24 months.     The study will examine the effects of the intervention on language development and reading     behaviors.   "
43714|NCT02713477|"     Primary Objective:      To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide     fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes     mellitus (T2DM).      Secondary Objectives:        -  To assess the pharmacokinetics (PK) of lixisenatide following administration of 2          different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese          patients with T2DM.        -  To assess the postprandial glucodynamic response to insulin glargine/lixisenatide          fixed-ratio combination compared to insulin glargine alone in Japanese patients with          T2DM.        -  To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio          combination in Japanese patients with T2DM.   "
43701|NCT02713646|"     Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular     compressions (NVC) on the patients with idiopathic trigeminal neuralgia (ITN). However, due     to lack of stereoscopic vision, this traditional method sometimes can not meet the     requirement on identifying the existence and details of NVC, especially when the aberrant     vessels turn out to be delicate veins. The three dimensional analytic techniques, such as     curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be     helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo     and dynamic views, so as to assist to design the surgical plan.      Furthermore, the frequent ﬁnding of NVC on MRI studies of asymptomatic patients incited the     creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross     perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the     root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve     may correlate with the severity of facial pain due to atrophy of the nerve in most cases of     ITN, and is likely secondary to the micro-structural abnormalities, such as axonal loss,     demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume     (V) of the cisternal trigeminal nerve will be assessed to determine whether it can be a     useful biomarker for predicting the degree of ITN.   "
43702|NCT02713633|"     This prospective study, Randomized Trial of Indwelling Double-J Ureteral Stent Versus     Externalized Modified-Salle Stent for Pyeloplasty will consist of four steps: 1.) Enrolling     subjects in the study and signing the consent form 2.) Randomly divide subjects into 2     groups, group 1 will have internal stent and group 2 will have external stent 3.) At the time     of stent removal in the clinic or in the OR subjects parents/ subjects will fill a     questionnaire about pain after the procedure, stent care and stent tolerance and 4) Data from     the questionnaires and procedure cost will be collected and all the data will be analyzed   "
43703|NCT02713620|"     This is a follow up study from the published article entitled Comparison of immunogenicity     and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination     in HIV-infected adults: a randomized, controlled trial by Chaiklang K, Wipasa J, Chaiwarith     R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov     12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov;     NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using     either four standard doses or four double doses compared with the current standard regimen of     three doses in HIV-infected adults in northern Thailand. In addition, the investigators     evaluated the efficacy of the HBV vaccination with the current standard regimen of three     doses between healthy adults and HIV-infected patients.   "
43704|NCT02713607|"     Lipidome and microbiome analysis in subjects with acne on doxycycline. Investigators will     look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome.      Investigators will look at the changes between acne subjects and control participants, but     also the changes that occur after the use of antibiotics and how this is altered.   "
43705|NCT02713594|"     The study is designed to test the hypotheses that financial incentives can increase both     participation in smoking cessation treatment and resulting cessation rates, when they are     offered to BadgerCare Plus (Medicaid) smokers as part of their health care.   "
43706|NCT02713581|"     The primary objective of this study is to search for, in vitro, elements associated with     IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant     and pro-inflammatory factors) and to describe their prevalence in female patients with a     history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary     embolism) compared to control women.   "
43707|NCT02713568|"     Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to     term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates     of fetal weight are poor. Historically, ultrasound has been used as a second line in such     cases but the accuracy of this imaging modality in the mid- to late third trimester is also     limited.      Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to     guide obstetric interventions, when a fetus is small or large for dates. It frequently is the     single most important component guiding interventions, such as induction of labour or     Caesarean section.      Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected     macrosomia in the 3rd trimester, the investigators believe that these estimates should not be     used to make important obstetric decisions regarding mode and timing of delivery and that a     more accurate method of assessment could produce better outcomes by restricting interventions     to those foetuses at greatest risk. Some publications have already demonstrated that magnetic     resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound      The goal of the present study is thus to compare the performance of magentic resonance     imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the     prediction of neonatal macrosomia.   "
43708|NCT02713555|"     Roux-en-Y Gastric Bypass surgery (RYGB) ameliorates type 2 diabetes within days after     surgery. Studies indicate that the gastric sleeve procedure has comparable effect on type 2     diabetes, but to what extent and how is not fully elucidated. This study investigates the     effect of the surgeries on incretin levels, glucose effectiveness and hepatic insulin     sensitivity.   "
43709|NCT02713542|"     This study is primarily investigating the effectiveness of Autologous Conditioned Plasma     (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.   "
43711|NCT02713516|"     Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for     anxiety disorders. Investigators aim to enhance this therapy with the use of virtual reality     exposures and to make therapy more available and accessible for patients with anxiety     disorders. The societal benefit of increased access to therapy is that, if successful, it     will increase the number of patients who receive appropriate treatment for an anxiety     disorder.   "
43712|NCT02713503|"     The purpose of this study is to evaluate a variety of technologies in a driving simulator.     Specifically, this research will provide a direct comparison of driver performance measures     under various modes of mobile device interaction.   "
43716|NCT02713451|"     No clear recommendation exists for the level of oxygenation of intensive care patients. In     Acute Respiratory Distress Syndrome (ARDS), pulsed oxymetry (SpO2) have to be kept between 88     and 95 percent and oxygen alveolar pressure between 55 and 80 mmHg (PaO2). These     recommendations are common but do not lie on high scientific knowledge and level of proof. In     the major studies of these fifteen last years that changed ARDS management, PaO2 was kept     around 85 and 90 mmHg despite current recommendations of 55 to 80 mmHg of PaO2.      Many recent review and cohort studies pointed the risk of excessive oxygenation especially     following cardiac arrest, stroke or traumatic brain injury. However, these data come in     majority from cohort or database study without strong definition of hyperoxia. Data coming     from prospective studies are scarce and tend to show better outcome of patients with lower     objectives of oxygenation in ICU.      High oxygen (O2) level may be deleterious especially on inflammatory lungs. It could enhance     injuries due to mechanical ventilation. O2 could be responsable of  hyperoxia induced lung     injury .      The investigators showed in a precedent study that comparing a restrictive oxygenation versus     a liberal oxygenation was feasable and do not expose patients to major adverse events. More,     mortality at 60 days has tendency to be lower. The investigators therefore ask if a lower     objectives of PaO2 in comparison with the level usually seen in last studies on ARDS could     improve ARDS patients outcome.      The aim of this study is to show that a restrictive oxygenation in comparison with a liberal     oxygenation strategy in patients with ARDS would lower mortality at 28 days.   "
43717|NCT02713438|"     AIMS: The project aims at investigating of the effects of three types of planning (individual     planning, collaborative planning, and dyadic planning) on physical activity.The influence of     three planning interventions are compared with an active control condition, including     physical activity education.      PARTICIPANTS: The effects of the interventions are evaluated among parent-child (aged 10-14)     dyads, with a minimum of 50 dyads enrolled into the each arm of the trial (a total of 200     dyads). The interventions consist of six planning sessions.      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after     the first intervention session, at post-intervention (after six intervention sessions are     completed), and at 6-, and 12-month follow-ups.      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of     planning (individual, dyadic and collaborative) are secondary outcomes.   "
43718|NCT02713425|"     This research study aims to test the feasibility and effectiveness of using an entertaining     video game as an addition to traditional therapy for the treatment of anxiety disorders in     youth, particularly those youth who may have limited access to mental health treatment in the     traditional clinical setting.   "
43728|NCT02713295|"     This study estimates the treatment goal achievement rate, depicts the implementation of the     Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and     transitioning, and assesses patient adherence and persistence with adalimumab therapy in the     routine clinical practice in Greece.   "
43729|NCT02713282|"     The purpose of this study is to estimate the proportion of participants fulfilling criteria     for symptomatic remission following a transition to 12 months treatment with flexible-dose     paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia     previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at     least 4 months.   "
43719|NCT02713412|"     To determine whether the changes in blood pressure (BP) which occur following meals in normal     people and patients who have substantial falls in BP after a meal postprandial hypotension     (PPH)) are associated with changes in cardiac function. Eligible subjects who have been     previously diagnosed with PPH will report to the Queen Elizabeth Hospital, on two occasions,     following an overnight fast. Subjects will be cannulated and have a BP cuff placed around     their upper arm. Following this, subjects will ingest either a drink containing 75 grams of     glucose and 150mg of a C13 Acetate (which is metabolised and excreted in the breath, enabling     noninvasive measurements of gastric emptying), made up to 300mL water, or on the other study     day, 300mL water alone. The order of the study days will be randomised. Following the drink,     for 3 hours, measurements will be taken at regular intervals of BP, heart rate, breath     samples (on the study day with the Acetate only), blood samples (for measurement of blood     glucose and gut hormones) and transthoracic echocardiography (TTE) (for assessment of end     systolic and diastolic cardiac volume, cardiac output, cardiac contractility and diastolic     function). After the 3 hours of measurements, the cannula will be removed and subjects will     be offered lunch prior to leaving the department. Following lunch, on one study day, subjects     will have their autonomic nerve function tested noninvasively, using an ECG.   "
43720|NCT02713399|"     A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia,     astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately,     cannot be prevented. There are different tools to correct them, like spectacles, contact     lenses, and refractive surgery. Many different contact lenses are available, the two large     groups create rigid contact lenses and soft contact lenses. It is a common knowledge that the     presence of a contact lens in the eye divides the tear film into the prelens and postlens     tear film layers. In the present study we want to investigate the variability and     reproducibility of prelens and postlens tear film thickness measurements.   "
43721|NCT02713386|"     This phase I/II partially randomized trial studies the side effects and the best dose of     ruxolitinib phosphate when given together with paclitaxel and carboplatin and to see how well     they work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or     primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving ruxolitinib phosphate together with paclitaxel and carboplatin may be a better     treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.   "
43722|NCT02713373|"     This phase I/II trial studies the side effects and best dose of cetuximab when given together     with pembrolizumab in treating patients with colorectal cancer that has spread from the     primary site (place where it started) to other places in the body (metastatic) or that cannot     be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block     tumor growth in different ways by targeting certain cells.   "
43723|NCT02713360|"     The hypothesis is that there is a significant difference in anxiety scores between     intervention and usual care group after intervention.      The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and     (ii) to investigate the effect of screening followed by randomisation to intervention with     consultations based on cognitive therapeutic principals to reduce anxiety in patients with     ICD or usual care.   "
43724|NCT02713347|"     Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) are common     serious illnesses. Despite disease-specific medical care for CHF and COPD, people with either     illness are often left with poor quality of life (i.e., burdensome symptoms, impaired     function). Furthermore, while CHF and COPD are leading causes of hospitalization and     mortality, few people with either illness engage in advance care planning, the process of     considering and communicating healthcare values and goals. The investigators are conducting a     randomized clinical trial to study a symptom management, psychosocial care and advance care     planning intervention to improve quality of life. The study is important because it aims to     improve quality of life and provision of care according to peoples' goals and preferences in     common, burdensome illnesses. Furthermore, this study will generate information that supports     the broader dissemination and implementation of the intervention and informs the development     of future palliative care and team-based interventions in the VA.   "
43725|NCT02713334|"     The objective of this protocol is to characterize advanced cancer patients' responses to     learning their secondary findings arising from tumor genomic profiling, and the process and     outcomes of their decisions to communicate these results to their families.   "
43726|NCT02713321|"     Type 2 diabetes is common in the United States; about 1 in 10 people have the disease.     Diabetes can cause devastating health events, such as hospitalizations, kidney failure,     blindness, amputation, heart attack, stroke, painful nerve damage (neuropathy), and death.     There are many barriers for patients with diabetes that get in the way of controlling risk     factors, following recommendations, and getting the care they need from the health system to     help prevent these complications; this is especially true for those with other health     problems too. Those living in poverty and racial/ethnic minorities are more likely to have     complications from diabetes, and less likely to get recommended care from health systems. In     order to improve care and outcomes for people with complex medical problems, several states     have started the Medicaid Health Home (HH) program, including New York State (NYS) in 2012.     This program is for people with two or more chronic health conditions, such as diabetes and     heart disease, people with HIV, and people with a serious mental health condition. HHs are     meant to manage and coordinate care, by helping health care providers, social service     agencies, community-based organizations, and health insurance plans work together. Similar     programs have been shown, on a smaller scale, to improve some results for patients with     diabetes, such as lab tests indicating level of diabetes control. Studies have not yet looked     at how a large program like HHs impacts the way healthcare is delivered and impacts the     health events that matter most to patients with diabetes. Also, few studies include     stakeholders on the research team, even though they stand to benefit the most from such     programs, and have the experience needed as patients, clinicians, advocates, and     administrators to guide efforts. The investigators have gathered a research team that     includes scientific investigators along with a diverse group of partners, including patients,     clinicians, and program administrators. The investigators plan to use two data sources that     show what happens to individual patients over time: 1) NYS Medicaid insurance data 2) the New     York City-Clinical Data Research Network (NYC-CDRN). The NYC-CDRN has identified a group of     patients with diabetes from 7 large health systems; it has also developed a system for     putting together the same set of information for each patient, and removing any identifying     information. The investigator will look at patients who have diabetes and are part of a HH     and study what happened to them over time. The investigator will also look at a comparison     group of patients who are very similar to the HH patients, but they did not join a HH, and     follow them over time. The investigator will then compare these two groups to each other. The     investigator will look at the quality of healthcare they received and their health outcomes.     The investigator will focus on health outcomes that are meaningful to patients. This study     can provide important knowledge about the effects of the HH program on patients with     diabetes.   "
43727|NCT02713308|"     Observational, retrospective and perspective study with acute and chronic endpoints   "
43730|NCT02713269|"     The goal of this clinical research study is to find out if combining thermal ablation (using     a laser to heat tumor tissue in order to shrink the tumor size) and spine stereotactic     radiosurgery (SSRS--a method for giving radiation) can help control cancer that has spread to     the spine.   "
43731|NCT02713256|"     An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks     treatment in patients with Graves' disease   "
43732|NCT02713243|"     The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid     diarrhea and to assess its safety and tolerability profile in patients with primary bile acid     diarrhea (pBAD) to guide decision-making regarding further clinical development in this     indication.   "
43733|NCT02713230|"     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in     approximately 120 adult subjects undergoing primary unilateral total shoulder arthroplasty or     rotator cuff repair with general anesthesia   "
43734|NCT02713217|"     Integrating mental health treatments into the primary care delivered at Community Based     Outpatient Clinics(CBOCs) that are geographically accessible to rural Veterans is a major     priority for the Department of Veterans Affairs. However, there is no scientific evidence     that integrating mental health and primary care is clinically effective at smaller CBOCs that     have limited mental health staffing. The goal of this proposed project is to implement a     blended combination of integrated care models that have been adapted for smaller CBOCs     using telemedicine technologies, and evaluate the acceptability and effectiveness of the     blended, telemedicine-based, integrated care model. If clinical outcomes are improved     compared to usual care, findings will be used to justify and facilitate the implementation of     this telemedicine-based integrated care model at smaller CBOCs in order to increase rural     Veterans' access to effective mental health treatments.   "
43735|NCT02713204|"     The primary objective of the study is to compare the efficacy of intravitreal     (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).   "
43736|NCT02713191|"     The randomized controlled trial will compare efficacy and safety of dexmedetomidine to     midazolam for sedation during endobronchial ultrasound   "
43737|NCT02713178|"     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in     approximately 300 adult subjects undergoing primary unilateral TKA under general or spinal     anesthesia.   "
43774|NCT02712684|"     In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic     strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar     detection of clinically significant prostate cancer?   "
44524|NCT02702921|"     This prospective, randomized, controlled, multi-center study will collect and compare data     from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein     transection) and powered vascular stapler.   "
43738|NCT02713165|"     Raisins contain a significant amount of dietary fiber and polyphenolic compounds that     represent an important substrate for microbiota fermentation which generates potentially     beneficial end products, such as short-chain fatty acids. The mammalian gut contains a     phylogenetically as well as functionally diverse microbiota that contributes to host     physiology. To date, little is known about how increased raisin intake affects human gut     microbiota composition.      This research study will assess the effects of adding raisins to the diet of healthy adults     on the bacteria from feces of human subjects and resulting self-reported GI symptoms as well     as markers of immune function. The hypothesis is that by adding raisins to the diet this will     result in changes in gut microbiota. Furthermore, the changes in microbiota will largely be     beneficial, as evaluated by an increase in butyrate producers and bacteria associated with     anti-inflammatory properties.   "
43739|NCT02713152|"     This study aims to investigate a potential link between Obstructive Sleep Apnoea (OSA) and     Open Angle Glaucoma (OAG); initially by determining whether the prevalence of OSA is higher     in patients with OAG in comparison to people without glaucoma and if OSA is an independent     risk factor for OAG. It will comprehensively phenotype glaucoma patients for variables that     may be associated with both OSA and OAG.   "
43740|NCT02713139|"     The purpose of this study is to determine the efficacy and safety of the association     clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when     compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g     (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.   "
43741|NCT02713126|"     Participants with heart failure with preserved ejection fraction will undergo 12 weeks of     cardiac rehabilitation for exercise training (ET) and be randomized to either nebulized     sodium nitrite inhalation solution or placebo inhalation solution (normal saline) through the     training period. Study drug is administered 3 times daily during daytime hours with one of     these doses being immediately prior to onset of ET sessions throughout the 12 week trial. The     objective is to determine if the inhaled sodium nitrite improves the clinical responses and     tolerability of ET.   "
43742|NCT02713113|"     the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2,     and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in     laparoscopic bariatric surgery.   "
43743|NCT02713100|"     In recent years, there has been an emphasis on assessing patient's pain on presentation to     emergency departments. The Joint Commission mandates that all patients who present with pain     must have a pain assessment performed and addressed early in their care. Most emergency     departments are using a self-reported assessment of pain using a 1-10 scale of pain. This     self-reported level of pain is used to determining appropriate treatment. The Joint     Commission has only dealt with somatic pain and has not addressed psychological related pain.      Many authors have written on psychological pain. It is described as introspective experience     of negative emotions such as anger, despair, fear, grief, shame, guilt, hopelessness,     loneliness and loss. The assessment of psychological pain has been used to describe patients     with depression and suicidal thoughts and behaviors.      Study Significance The significance of this study is to determine if patients can communicate     the level of psychological pain using the level of agitation as a surrogate marker. Studies     have demonstrated that the staff's assessment of a patient's level of agitation is not based     on an agitation scale nor uses any patient self-assessment of their level of agitation. If a     self-assessment of a patient's level of agitation can be determined early in their care in     the emergency setting, a proactive approach to treatment can occur. Proactive agitation     treatment has the potential of reducing a patient's agitation and increasing their level of     comfort. This early intervention can reduce the progression of agitation and the risk of     injury to patients, families and staff.      Hypothesis The study null hypothesis is that the self-rated agitation scale will not have a     significant level of correlation with the other measures of agitation (Brief Agitation     Measure, Positive And Negative Syndrome Scale and Agitation Calmness Evaluation Scale). The     secondary null hypothesis is that there is no difference between the level of agitation and     the level of psychological pain, assessed with the Psychological Pain Assessment.   "
43744|NCT02713087|"     Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in     Anesthetized Patients with Cerebral Tumors      Sponsor-investigator: Klaus Ulrik Koch M.D.      Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C,     Denmark      Objective:      To investigate whether phenylephrine and ephedrine causes different alterations in     microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients with     brain tumors. Using MRI and PET, the study will assess whether there is a difference in     deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral     metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine      Method:      Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are     infused intravenously under general anesthesia. MRI is performed in 20 patients before and     after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS     monitoring will be used in either scanner. After scanning patients are transported to the     operating theatre and the craniotomy is performed. After removal of the bone flap subdural     ICP is measured and recorded.      MRI to analyze CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine     and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and     phenylephrine and calculation of OEF. During each PET/CT scan session oxygen saturation and     hemoglobin concentration is measured.      Data from the proposed studies will add substantial new knowledge to the investigators     current understanding of the effects of vasopressors on cerebral circulation. This     information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the     choice of the optimal method to manage cerebral perfusion pressure during craniotomy for     brain tumor.   "
43745|NCT02713074|"     The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning     wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike     many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.   "
43746|NCT02713061|"     This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22     days in healthy Japanese adults.   "
43747|NCT02713048|"     Troponin is a major diagnostic criterion of acute myocardial infarction (AMI) which confirms     myocardial damage and necrosis. In out-of-hospital cardiac arrest (OHCA) patients its     dynamics and diagnostic value is often controversial and has not been well described. Most of     prior studies were retrospective, using first generation troponin assays and assessing only     admission troponin. The aim of this work is to correlate dynamics of sensitive troponin I     with urgent coronary angiography.      Patients resuscitated after OHCA will be prospectively divided in three groups based on the     results of their urgent angiographies. Serial assessment of sensitive troponin I will be     obtained over initial 48 hours.      We expect admission troponin will not be predictive of AMI. Over next hours troponin levels     will be highest in patients with acute coronary lesion, lower in stable obstructive coronary     disease and insignificant in non-obstructive coronary disease. We also expect significant     difference in highest values and dynamics of troponin in sub-group with spontaneous     reperfusion (TIMI flow 2 and 3) comparing to patients with coronary occlusion (TIMI flow 0     and 1). In patients with non-obstructive disease we expect troponin levels to correlate with     duration of cardiac arrest, number of external electric shocks and cumulative dose of     adrenaline administered.   "
44202|NCT02707120|"     Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered     innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the     regeneration deterioration and development of corneal ulceration, their fusion, and     perforation The main characteristic in the NK is a decrease or absence of corneal     sensitivity.   "
43749|NCT02713022|"     The investigators want to find a better way to predict the risk of having fatty tissue     inflammation by using a different approach to finding out body fat composition. In this     study, the investigators want to estimate the body fat composition using a DEXA scan. DEXA     stands for dual energy X-ray absorptiometry. It is the standard and established test to     determine bone mineral density (how strong the bones are) to diagnose osteoporosis. This test     can also be used to determine the body composition including percent body fat and lean mass.     The investigators will compare the participants DEXA scan results for body fat composition to     the inflammation found in the breast tissue from the mastectomy to see if there is a     relationship. If successful, this may help us predict which patients may be at risk for     breast cancer in the future. In addition, the investigators will compare the participants     DEXA scan results for body fat composition and inflammation found in the fat tissue from the     mastectomy or prostatectomy to the level of exercise activity as measured by a short     questionnaire to see if there is a relationship. The investigators will also measure the     participants waist to hip ratio.      Finally, at the time the participant has blood drawn for their standard presurgical testing,     the investigators will also test the blood for prediabetes using a blood test called     hemoglocin A1c. The investigators will also measure for the participants waist to hip ratio,     and a Hgb A1c blood drawn will be take at the time of presurgical testing. If not feasible,     Hgb A1c can be drawn at a separate visit prior to the DEXA scan. If successful, this may help     us predict which patients may be at risk for breast cancer in the future.   "
43750|NCT02713009|"     Research shows high levels of vitamin D deficiency in pregnant women in Northern Ireland.     Body composition is a determinant of vitamin D status. Vitamin D is a fat soluble vitamin and     therefore may be hidden within the adipose/fat tissue in overweight/obese individuals. All     pregnant and breastfeeding women are advised to take a daily supplement containing 10μg     vitamin D. The investigators hypothesise that overweight/ obese pregnant women have a lower     vitamin D status than their leaner counterparts at the start of pregnancy and may need a     higher daily supplementation to achieve a sufficient status.      The investigators propose a randomised supplementation study where pregnant women (n 240)     from the Western Health and Social Care Trust Area will be invited to take part.      Inclusion criteria: pregnant women first trimester, without current pregnancy related     complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) > 18.5kg /m².      Participants will be randomised to receive either 0μg (placebo) plus a multivitamin or 10μg     vitamin D plus a multivitamin from 12 weeks gestation until delivery. The multivitamin     already contains 10μg vitamin D; Therefore participants will be randomised to receive a total     of 10μg or 20μg vitamin D.      Blood samples (20mls) will be taken at 12, 28 and 36 weeks gestation. A sample of blood will     be taken from the cord after delivery. Vitamin D status is the main outcome measurement. All     blood samples will be analysed for vitamin D and other associated metabolites. Data will be     collected on health and lifestyle, supplementation use and food intake. Body composition     measurements will be recorded at each appointment and infant anthropometric measurements will     be taken from the maternal notes after delivery. Findings from this research will be used to     inform nutrition policy on appropriate vitamin D supplementation levels in pregnancy which     may be dependent upon pre pregnancy BMI.   "
43751|NCT02712996|"     The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can     help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse     is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact     effects this drug may have on adults with attention deficits caused by TBI have been     investigated prior. The exact effects this drug may have on children with attention deficits     caused by TBI are not known, but the investigators expect that Vyvanse will be of some help     in treating this population as well.   "
43752|NCT02712983|"     The purpose of this study is to support the selection of a safe and tolerable tobramycin     inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P.     aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa     colonization.   "
43753|NCT02712970|"     A staging system was defined based on morphological extent of disease (stage I to stage IV     for primary disease, and stage R for recurrent disease). Specific surgical technique was used     for each stage. Demographics, perioperative data, short-term and long-term outcomes were     evaluated according to the disease stage.   "
43754|NCT02712957|"     The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in     patients with pain associated with osteoarthritis of the knee.   "
43755|NCT02712944|"     The purpose of this trial is to evaluate the effect of testosterone replacement in men with     renal failure (on dialysis) who also have low testosterone. Specifically, the investigators     will assess the change in requirement of Erythropoietin Stimulating agents.   "
43756|NCT02712918|"     The purpose of the current study was to examine Brief Behavioral Activation Treatment for     Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly     depressed inpatients. The study is a systematic replication of a randomized controlled trail     from 2003, that provided initial support for BATD With inpatients. The current study compared     BATD to Treatment as Usual in a randomized controlled trial.   "
43757|NCT02712905|"     This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with     advanced malignancies. The study will be conducted in 2 parts. Part 1 (dose escalation) will     determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum     tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will     further determine the safety, tolerability, efficacy, PK, and PD of the selected dose(s).   "
43758|NCT02712892|"     Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of     the general population. The devastating complication of IA is its rupture, resulting in     subarachnoid haemorrhage that can lead to severe disability and death. Unfortunately, there     are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of     an IA in a given individual. Also, there is no pharmacological drug available to prevent the     rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive     with a significant risk of procedural morbidity. Thus, still now, the management of patients     with IA remains extremely challenging and still controversial. Although the pathogenesis of     IA has been the subject of many studies for the last decade, the mechanisms underlying IA     formation, growth and rupture are still mostly unknown and relevant animal models of IA are     not available. Familial history of IA predisposes to IA formation and rupture and increasing     evidence suggest a genetic component of IA formation, with heterogeneous modes of inheritance     and penetrance. This project, gathering neuroradiologists, geneticists and vascular     biologists, addresses the urgent need to understand the pathogenic mechanisms of IA to     develop diagnostic and predictive tools of risk of IA. The investigators propose to identify     IA-causing variants by whole-exome sequencing in familial forms of the disease. The     investigators hypothesises that the functional analysis of the causal/susceptibility variants     thus identified will provide clues to understanding the pathological mechanisms of IA     formation, and the bases for developing diagnostic tools. This project aims at meeting this     challenge. Based on preliminary data that already allowed to identify such a variant, and the     combination of genetic and functional investigations, the specific objectives of this project     are: - To identify IA-causing variants in familial forms of the disease by whole-exome     sequencing; - To understand the function of these genes/variants in the formation and rupture     of IA by molecular and cellular approaches and generation of relevant animal models; - To     discover potential biomarkers of risk of IA formation and/or rupture.   "
43759|NCT02712879|"     Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the     drainage system to define moderate bleeding postoperative cardiac surgery and define the     population.   "
43760|NCT02712866|"     Background: Infiltration of GI by T lymphocytes is a pathogenic mechanism both in ulcerative     colitis (UC) and in Crohn's disease (CD). Vedolizumab (VDZ) is a humanized monoclonal     antibody binding with high affinity to α4β7 integrin blocking α4β7+-MAdCAM-1 interaction,     hence blocking a key step in GI lymphocytes T infiltration. VDZ has demonstrated a     therapeutic effect in UC and CD. Investigators still lack of adequate biomarkers to predict     clinical response to biological treatments, specially avoiding invasive procedures.      Objective: Study whether circulating CD4+ and CD8+ α4β7+ memory T lymphocytes and some of     their surface markers might be molecular markers of response to VDZ treatment in patients     with UC and CD.      Methods: Prospective (pilot) study including 24 adult IBD patients (12 UC patients and 12 CD     patients (patients with fistulizing perianal disease will be excluded) with active disease     and prior failure to anti-TNFα treatments starting treatment with VDZ. They will received VDZ     in standard induction (300mg intravenously, 0-2-6 weeks) and maintenance schemes (300mg     intravenously, every 8 weeks).      Epidemiological and clinical data from every patient will be recorded prospectively. Disease     activity at weeks 0, 2, 6 and 14 weeks will be evaluated through validated clinical scores,     biological parameters and fecal biomarkers.      At week 14 response to the treatment will be evaluated by ileocolonoscopy or enteroMRI.      Peripheral blood will be obtained from every patient at baseline, before the third infusion     of VDZ (6th week) and before the first maintenance dose (14th week).      Blood lymphocytes will be isolated and multicolor flow cytometry will be performed on stored     circulating memory T cells.      Percentage and absolute values of circulating CD4+ and CD8+ α4β7+ memory T lymphocytes as     well as several surface markers related to their activation state (HLA-DR, CD25), Th17     phenotype (IL23R, CCR6, intracellular IL17A) and Th1 phenotype (INFγ)will be assessed on     α4β7+ memory T cells.   "
43761|NCT02712853|"     The goal of this project is to identify specific miRNAs that are increased or decreased in     the saliva of children with developmental delay and are useful for screening toddlers for     ASD. Such a screening tool would improve the specificity of diagnosis, streamline referrals     to developmental specialists, and expedite the arrangement of early intervention services.   "
43762|NCT02712840|"     The purpose of this study is to determine whether the chances of becoming pregnant are better     when day the single best day 5 embryo (blastocyst) resulting from an in vitro fertilization     (IVF) cycle is transferred into the uterus immediately, or after freezing the embryo and     transferring it into the uterus in a subsequent cycle, separate from the ovarian stimulation     used in the IVF cycle. The investigators hypothesize that in good-prognosis patients,     vitrified-warmed elective single embryo transfer will result in higher implantation, clinical     and on-going pregnancy and live birth rates than fresh elective single embryo transfer at the     blastocyst stage.   "
43799|NCT02712359|"     The purpose of this study is to evaluate the persistence of hepatitis A antibodies,     approximately 8 years and 10 years post vaccination with the complete series of Havrix (2     doses) and the partial series completion (1 dose).   "
43800|NCT02712346|"     The primary goal of the study is to determine the safety and tolerability of ambrisentan. It     is also expected that ambrisentan will improve blood flow in the lungs, decrease     inflammation, and reduce pain in sickle cell patients. An additional goal is to evaluate the     use of select biomarkers in evaluating sickle nephropathy.   "
43801|NCT02712333|"     This study aims to detect serum metabolite changes, as well as other health indicators with     the intervention of air purifiers on a randomized, crossover, double-blind trial.   "
43802|NCT02712320|"     This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after     the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain     eligible for continued treatment with androgen deprivation therapy. Subjects participating in     Protocol FP01C-13-001-EX will be followed for safety only.   "
43763|NCT02712827|"     The placement of mesh is important in hernia surgery as it helps to reduce recurrence, yet     the method of fixation of mesh may cause pain after surgery. In laparoscopic hernia repair,     surgeon uses different methods to fix the mesh in large hernia defects or bilateral inguinal     hernias. Progrip is a special mesh developed by manufacturer that it can be self-gripped to     tissue, as a result no fixation is required after placement. There are few data about Progrip     in laparoscopic hernia repair. In this randomized controlled trial we would like to compare     the use of Progrip with the conventional mesh in laparoscopic hernia repair. Surgery is     performed in the usual manner; prior to placement of mesh, surgeon will get the randomization     result for that particular patient: Progrip and non-Progrip group. No fixation is required     for Progrip group, while fixation with fibrin glue is needed for non-Progrip group.     Intraoperative data (e.g. mesh deployment time, operative time, etc) will be collected.     Patients will be assessed in clinic at 2-week, 3-month, 6-month and 1-year interval after     surgery. Additional visits may be arranged if considered necessary. At follow up patient will     be seen by surgeon first to review the wound condition and to look for any recurrence; while     other post-operative data including total analgesic usage (number of tablets), return to     normal activities (days), return to work (days), pain score etc will be assessed and recorded     by a trained nurse who is blinded to the treatment that patient received. Any hernia     recurrence will be recorded and treated accordingly. Primary aim of this study is to look for     any difference of the 2 groups in terms of postoperative pain and quality of life scores.   "
43764|NCT02712814|"     The proposed study will evaluate a clinical algorithm for the diagnosis and treatment of     provoked vestibulodynia (PVD). The algorithm, distinguishes between four subtypes of PVD:     hormonally mediated PVD, hypertonic pelvic floor dysfunction, congenital neuroproliferative     PVD and acquired neuroproliferative PVD, based on a patient's history and physical exam. The     study will follow patients diagnosed with PVD, for one year, and evaluate the treatment     outcome in the different subgroups. Investigators hope that conducting a prospective study,     showing clinical benefit and improved outcome for patients classified according to this     method may change the common practice of trial and error based treatment, and will improve     clinical results.   "
43765|NCT02712801|"     This is a multi-center, randomized, controlled, open clinical trial. The trial will be     carried out in five provinces in China. Pregnant women with HIV infection and at high risk of     mother-to-child transmission of HIV will be identified. Their newborn babies who are at high     risk HIV infection will be recruited and randomized into intervention and control groups.     Children in intervention groups will receive ART and intensive HIV testing after birth.     Children in control group will receive routine prevention of mother-to-child transmission     services. All the included children will be followed up and their development and infection     status will be recorded and compared.   "
43766|NCT02712788|"     The purpose of this study is to evaluate the usefulness of adding Milrinone to the current     standard treatment for cerebral vasospasm.   "
43767|NCT02712775|"     Liver transplantation is the sole therapy for end-stage liver diseases and acute liver     failure in children and adults. However, use of this life-saving technique is limited due to     a severe shortage of donor livers. The number of transplants currently performed is     approximately one-third of the number needed to accommodate the more than 16,000 patients     awaiting an organ in the US. Over 20% of patients on the liver transplant waiting list die     prior to transplantation due to organ shortages. The median waiting time in 2011 was over 300     days. Poor immediate graft function and primary non function (PNF) are clinically significant     events, especially in recipients of marginal livers (elderly donors, extended cold storage     time, or steatosis). PNF has dramatic effects on patient morbidity and mortality,     necessitating prolonged and expensive stays in intensive care units, and re-transplantation     is the only life-saving therapy in patients with failing liver grafts due to PNF. This     further exerts greater burden on the already scarce donor organ pool. Furthermore, biliary     strictures and ischemic cholangiopathy, as a result of severe ischemia reperfusion injury,     cause prolonged hospital stay, long-term complications, and increased costs. Targeted     treatments, such as the one proposed in this application, will reduce the need for     re-transplantation, reduce biliary injury, and potentially increase the number of donor     organs available.   "
43775|NCT02712671|"     Human Immunodeficiency Virus (HIV) is the strongest individual risk factor for the     reactivation of tuberculosis (TB) after previous exposure to Mycobacterium tuberculosis     (MTb). This risk is reduced but not completely eliminated when HIV is treated with     antiretroviral therapy (ART). Both the British HIV Association (BHIVA) and National Institute     of Health and Care Excellence (NICE) suggest testing for latent TB infection in HIV infected     individuals, but use different criteria. The cost -effectiveness of either approach has not     been assessed, nor is testing widespread. A certain proportion of HIV infected subjects in     Africa have MTb detectable in their sputum despite not having symptoms (such as cough or     weight loss), nor changes on a chest x ray. It is unclear if this happens in lower TB     prevalence areas such as the United Kingdom (UK). We intend to test a cohort of HIV infected     subjects for evidence of latent TB using a tuberculin skin test (TST) and Interferon Gamma     Release Assay (IGRA), ask about symptoms (using a standardised questionnaire) and to induce     sputum using a saline nebuliser, to detect MTb using microscopy and culture, and newer     nucleic acid amplification (genetic) techniques. Some patients, despite being exposed to TB     in the past, will not mount a response using an IGRA or TST, which maybe due to an abnormal     immune response. This lack of response seems more common in HIV. By investigating the number     of patients with positive TST, IGRA, chest X ray and evidence of MTb in their sputum, in the     context of place of birth, previous exposure to TB, CD4 count and other medications, we can     assess the cost- effectiveness of systematic TB screening and the use anti-TB antibiotics to     prevent reactivation of TB. In time, we will be able to answer important questions about the     time taken to reactivate TB in individuals with HIV who do or don't take preventative anti-TB     medications in the UK.   "
43776|NCT02712658|"     The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle     fatigue in trained young men.   "
43777|NCT02712645|"     This study is being performed to collect blood for the development of noninvasive tests that     can screen for or diagnose cancer. Blood samples will be collected from women who are     scheduled to have breast biopsies.   "
43812|NCT02712190|"     The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation     on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and     patients with lung disease.   "
43869|NCT02711449|"     To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative     pain after laparoscopy for suspected appendicitis and to test whether preoperative     methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea     or vomiting, reduce duration of convalescence and increase overall quality of recovery after     laparoscopy for suspected appendicitis.   "
43778|NCT02712632|"     The GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet     the planned inclusion criteria. The study aims to investigate biomarkers associated with     diabetes progression, therapeutic response, diabetes complications and related traits, and     specifically to investigate mechanisms of action and response to metformin. The study will     specifically target patients who have been diagnosed within the past 2 years and follow up     will be by linkage to electronic health record data. Up to 6,000 patients will be recruited     into the study over a period of 2-3 years with a primary aim to identify 1000 of these     patients who should be suitable to be started on metformin therapy.      Most patients will undergo a single screening visit lasting approximately 20 minutes     conducted on an outpatient basis. Patients commenced on metformin therapy will need to attend     a second clinic visit to be carried out between 4-6 months after initiation of metformin     therapy.      Up to 9 health boards will be approached regarding participating in the study, and it is     estimated that between 4-6 diabetes patients will be recruited into the study each week, at     each site.      All screened patients will provide consent for data linkage and longitudinal follow up and     their samples and data will be used to supplement the SHARE/SDRN bioresource. The collection     into the resource will be managed by the co-ordinating centre study team based at the     University of Dundee/NHS Tayside. The resource will be hosted by the Tayside Biorepository     and access to samples and data will be managed by the Tayside Biorepository on behalf of the     whole of Scotland.   "
43779|NCT02712619|"     Two doses of metformin with 12 hour interval        -  low dose group (375/250 mg)        -  high dose group (1000/1000mg)   "
43780|NCT02712606|"     A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo,     Irvine, CA, USA) in children with cyanotic congenital heart disease   "
43781|NCT02712593|"     This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite     concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a     placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will     receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and     one quarter will reveive the placebo.   "
43782|NCT02712580|"     This study will determine the effect of the wireless micro current stimulation in pediatric     deep dermal burns and scald injuries. The clinical trial ist designed as a blinded,     placebo-controlled, randomized, prospective, single-center study.   "
43783|NCT02712567|"     SARC021C is a nonrandomized, open-label, multicenter, continuation study designed to provide     access to TH-302 for patients currently receiving and benefiting from single agent TH-302     therapy as part of the Phase III TH-CR-406/SARC021 study.   "
43784|NCT02712554|"     The purpose of this study is to assess the abuse potential of CL-108 tablets, including the     abuse deterrent effects of promethazine, following oral administration, relative to     hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid     users.   "
43785|NCT02712541|"     The purpose of this study is to determine whether there is an association between adverse     physical and/or psychological outcome in ICU survivors and the caregiver burden for their     relatives.      We hypothesize that relatives to ICU survivors with an incomplete physical and/or     psychological recovery three months after ICU stay report a higher caregiver burden.   "
43792|NCT02712450|"     According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French     911) calls concern elderly patients above 75 years of age. For these patients, the clinical     pathway should be decided on the basis of the symptomatology described during the call, but     also with the gathering of specific data such as medical social and psychological evaluation.     These items allow the regulating doctor to assess comorbidity, on-going treatment,     psycho-cognitive status, previous hospitalisations, social situation, and patient     expectations and needs.      However, data collected in order to assess the situation on the phone and take the     orientation decision are mainly limited to the severity of clinical symptoms. Medical,     psychological and social aspects are rarely gathered, for several reasons :        -  Phone call shortness : emergency calls should be treated quickly        -  Regulating doctors are not trained to take in account the specificities or geriatric          patients in their decision making. Besides, they are not informed about alternatives to          the hospital emergency department, such as geriatric channel system.      An observational study was performed in 2012 on 692 calls about elderly patients referred to     the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency     department. Regardless of severe cases hospital regulation, 55% of the least serious cases     (liberal regulation) were transferred to an emergency department.      Regulation is inadequate to elderly patients for whom 1) the situation assessment and the     appropriate decision making require specific items that are not known by regulating doctors,     2) the medical care and the clinical pathway could be improved by the knowledge of on-field     geriatric channel, 3) the emergency department care is particularly long, 4) and could be     pernicious to younger patients.      1920 patients will be recruited between January 2016 and August 2017, including a 6 months     wash-out in order to train regulating doctors. This training will include geriatric patient's     specificities, and geriatric channels. A 12% difference between the 2 groups (before and     after the training) is expected, considering a 80% statistical power. The design is a time     series experiment.   "
44203|NCT02707107|"     Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses     of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.   "
43786|NCT02712528|"     Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine     the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac     surgery include patient's recovery in cognitive function from the postoperative residual     effects of anesthetics, such as opioids and sedatives, administered during intraoperative     period. Therefore employing anesthetic regimens which can provide earlier recovery in     cognitive function would be beneficial in facilitating fast-track cardiac surgery with     earlier postoperative extubation and discharge from the intensive care unit (ICU).      Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative     hypnosis in the ICU.      The present study compares the time for reaching BIS greater than 90 after using 2 different     anesthesia regimens for cardiac surgery, remifentanil-based regimen and     sevoflurane-sufentanil balanced regimen.      Analyzing the changes immediately after cardiac surgery would be useful to determine the     degree of patient's postoperative emergence.      Materials and Methods:      During study period, patients undergoing elective coronary artery bypass graft surgery in     Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen     consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS     40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min)     balanced regimen in Group S.      All patients get intravenous patient controlled anesthesia consisting of alfentanyl and     ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered     during postoperative 2 hours in Group R.      As a primary objective, inter-group difference in the time for achieving BIS greater than 90     is determined.   "
43787|NCT02712515|"     Essential tremor (ET) is among the most common movement disorders, and is the most prevalent     tremor disorder. It is a progressive, degenerative brain disorder that results in     increasingly debilitating tremor, and afflicts an estimated 7 million people in the US (2.2%     of the population) and estimates from population studies worldwide range from 0.4% to 6.3%.     ET is directly linked to progressive functional impairment, social embarrassment, and even     depression. Intention (kinetic) tremor of the arms occurs in approximately half of ET     patients, and is typically a slow tremor (~5-10Hz) that occurs at the end of a purposeful     movement, and is insidiously progressive over many years. Based on direct and indirect     neurophysiological studies, it has been suggested that a pathological synchronous oscillation     in a neuronal network involving the ventral intermediate nucleus (Vim) of the thalamus, the     premotor (PM), primary motor (M1) cortices, and the cerebellum, may result in the production     of ET. In spite of the numerous therapeutic modalities available, 65% of those suffering from     upper limb tremor report serious difficulties during their daily lives. Deep brain     stimulation (DBS) has emerged as an effective treatment option for those suffering from     medically refractory ET. The accepted target for ET DBS therapy is the Vim thalamus. Vim     projects to PM, M1, and supplementary motor areas (SMA) and receives afferents from the     ipsilateral cerebellum. Moreover, electrophysiological recordings from Vim during     stereotactic surgery have identified tremor cells that synchronously discharge with     oscillatory muscle activity during tremor. Clinical and computational findings indicate that     DBS suppresses tremor by masking these burst driver inputs to the thalamus. The overall     goal is to investigate the neural signatures of tremor generation in the thalamocortical     network by recording data during DBS implantation surgery. Investigators will record data     from the macroelectrode implanted in the Vim for DBS therapy, and through an additional     6-contact subdural cortical strip that will be placed on the hand motor cortical area     temporarily through the same burr hole opened for the implantation of the DBS electrode.   "
43788|NCT02712502|"     Inflammatory paranasal diseases are among the most common diseases in ENT In Russia, puncture     method has been conventional approach to treatment of maxillary sinusitis. However, this     procedure is associated with a number of drawbacks A promising trend for the treatment of     purulent sinusitis is a reasonable antibacterial therapy Fluoroquinolones, particularly     levofloxacin, are highly active against pneumonocci and are more active vs. the drug products     of the second generation against intracellular agents (Chlamydia spp., Mycoplasma spp., M.     tuberculosis, rapidly growing atypical mycobacteria (M. avium, etc.).      Due to high activity against the agents causing bacterial upper and lower respiratory tract     infections they are sometimes called respiratory fluoroquinolones   "
43789|NCT02712489|"     A roll-over observational study (ISS T-003 EF-UP) is being conducted to extend the follow-up     of the volunteers of the ISS T-003 trial in order to evaluate the persistence of vaccine     immunogenicity as well as of the immunological and virological effects induced by the     therapeutic immunization with Tat.   "
43790|NCT02712476|"     Although mannitol is used for brain relaxation during neurosurgery and in the treatment of     raised intracranial pressure; there is not a consensus on its safe and effective dose, the     duration of its administration and its use in combination with loop diuretics. This study     aimed to compare the effects of the mannitol alone and in combination with furosemide in     different doses, on the brain relaxation, electrolyte, lactate levels of the blood,     peroperative fluid balance and the volume of the urine in supratentorial mass resection     surgeries.      This prospective, randomized, double blind, placebo controlled study included fifty one     patients (ASA I-III) scheduled for elective supratentorial mass resection surgery. The     patients were randomized into three groups for investigation of the effects of mannitol alone     and in combination with furosemide in different doses. Blood sodium, potassium, chlorine,     lactate, urine and osmolarity levels were recorded. The brain relaxation score (BRS) was     evaluated twice by the surgeon using a 4 point scale (1=very good, 2=good, 3=bad, 4=very     bad); at dura opening, and 30 minutes after the administration of the study drug.   "
43791|NCT02712463|"     The primary purpose of the study is to compare the rate of hospitalization associated with     psychotic relapse in participants with schizophrenia treated one year before with oral     antipsychotics and one year after with long acting injectable atypical antipsychotics.   "
43793|NCT02712437|"     Women with early stage breast cancer may experience difficulty falling asleep or staying     asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia.     Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of     medications for sleep and an overall decrease in quality of life.      The investigators have developed an internet-based website that is designed to help people     manage symptoms typically experienced by breast cancer survivors, including insomnia,     fatigue, pain and overall poor quality of life. The investigators want to learn whether this     type of treatment can reduce chronic insomnia and improve the way subjects feel using both     questionnaires and a special form of a wrist watch. This information may help the     investigators better manage sleep difficulties in subjects who experience these symptoms     after diagnosis of their breast cancer.   "
43794|NCT02712424|"     DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed     with BCG to determine if immunization reduces the risk of TB infection   "
43795|NCT02712411|"     To investigate the pharmacokinetic properties and safety after administration of HCP1303 and     co-administration of HGP1201, HIP1402 in healthy male volunteers   "
43797|NCT02712385|"     BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI with     TIA survivors often being left with considerable functional impairment. TIA and strokes share     common risk factors with cardiovascular disease. Cardiac rehabilitation post-myocardial     infarction has shown significant reductions in morbidity and mortality, with home-based     programmes producing better adherence and similar outcomes to hospital-and community-based     programmes. However, the value of rehabilitation programmes for stroke prevention following a     TIA or minor stroke is unclear.      AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Rehabilitation     Manual', for TIA/minor stroke patients can be developed, using MRC guidelines for developing     complex health service interventions, from an approved home-based cardiac rehabilitation     programme (the 'Heart Manual') and to undertake feasibility and pilot studies of the novel     programme.      METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first TIA/mild     stroke will be invited to participate. The novel home-based programme manual will be     developed following systematic reviews of the literature and qualitative exploration with the     target population, using focus groups. A feasibility study will initially be undertaken     lasting 6 weeks and then developed into a pilot trial of 12 weeks duration. The feasibility     will recruit to 3 different treatments: (1) standard care; (2) standard care plus the manual;     (3) standard care, manual plus a pedometer. Whilst for the pilot study there will also be 3     arms but this will include: 1) control group; 2) manual and pedometer supported by telephone     follow-up with a GP; 3) manual and pedometer supported by telephone follow-up with a stroke     nurse. Interviews and focus groups will be employed to assess the interventions'     acceptability. The intervention, 'The Healthy Brain Rehabilitation Manual' will be refined     and modified at all stages of the research.      CONCLUSIONS - The findings will inform the development of a novel secondary prevention     programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients and of a     trial to test its effectiveness and longer-term potential to improve outcomes for TIA/stroke     patients.   "
43798|NCT02712372|"     This is a Phase I, first-in-human (FIH) study to assess the safety, tolerability,     pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD4831 after single and multiple     ascending doses in healthy male subjects   "
43803|NCT02712307|"     The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4)     versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults,     adolescents and children with streptococcal tonsillitis. Patients are recruited from 17     primary Health care centres in the south of Sweden. Adult men and women, youth and children ≥     6 years of age who are visiting the primary Health care for sore throat with suspected     tonsillitis and meeting the criteria in accordance with current treatment recommendations for     pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the     tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for Group A     streptococcus (GAS) will be included in the study. Patients will be randomized to be     prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary     including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days     after last intake of PcV the general practioner make a clinical judgement if the patient has     recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or     new symptoms of sore throat is present, if adverse events have been noted or of any extra     physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus     group A, C and G are made at randomization and five to seven days after last intake of PcV. A     study nurse will contact the patients one month and three months after the last treatment day     for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or     possible complication, those patient records will be examined.   "
43804|NCT02712294|"     Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic     response, pulmonary function and exercise capacity.      Non-pharmacological interventions are low cost and can significant enhance outcomes in these     patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable     therapeutic approach in patients with functional limitations, particularly those that present     with difficulty to perform exercise protocols.      Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality     of life of patients with PH.      Material and methods: prospective randomized controlled study with a control group (GC, n9)     and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk     test (6MWT) were assessed before and after the NMES protocol.      Results: the GE presented with a significant improvement in distance walked in the 6MWT,     cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and     social aspects of the questionnaire Short Form Health Survey-36.      Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved     exercise capacity, quality of life and lung function testing.   "
43805|NCT02712281|"     The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent     training intervention designed to assist parents in increasing the variety of foods eaten in     children with Autism Spectrum Disorder (ASD). The goal of the Autism MEAL Plan is to include     specific techniques to manage mealtime behavioral challenges and introduce new foods.   "
43806|NCT02712268|"     This study tested the efficacy of an easy-to-use checklist aimed at supporting the     therapeutic reasoning of physicians in order to reduce inappropriate prescribing and     polypharmacy in elderly adults admitted to an internal medicine unit.   "
43817|NCT02712125|"     Objective: To assess the influence of maternal isosorbide mononitrate (IMN) vaginal     supplementation in improving liquor volume in women with isolated oligohydramnios.      Study Design: Prospective randomized interventional study. Materials and Methods: 100 women     with singleton pregnancy about 28-36 weeks, with isolated oligohydramnios [amniotic fluid     index (AFI) < 5] were enrolled in the study. Before the proposed intervention, the antenatal     risk factors were studied. Patients received 20 mg isosorbide mononitrate (IMN) vaginally.     Patient were followed after 24 hours then weekly. The treatment was continued till the liquor     improved significantly or until delivery. Outcome measures; mean increase in liquor,     intervention delivery interval, and neonatal outcome were studied.   "
43807|NCT02712255|"     THE AIMS: The project aims at investigating of the effects of three types of planning     (individual planning, collaborative planning, and dyadic planning) on physical activity.The     influence of three planning interventions are compared with an active control condition,     including physical activity education. PARTICIPANTS: The effects of the interventions are     evaluated among dyads of patient and his/her partner. The patients with physical     activity-related chronic diseases (cerebrovascular diseases or diabetes) will be enrolled. A     minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The     interventions consist of six planning sessions.      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after     the first intervention session, at post-intervention (after six intervention sessions are     completed), and at 6-, and 12-month follow-ups.      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of     planning (individual, dyadic and collaborative) are secondary outcomes.   "
43808|NCT02712242|"     Backgroung: Various agents are used to reduce post-operative complications associated with     palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted     to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.   "
43809|NCT02712229|"     The overall goal of this study is to test whether a nurse-led intervention to improve     provision of primary palliative care within oncology practices (CONNECT) can decrease     morbidity for patients with advanced cancer and their caregivers.      The specific aims are to:      Aim 1. Assess the effects of CONNECT on patient quality of life (primary outcome), symptom     burden, and mood at 3-month follow-up.      Aim 2. Assess the effects of CONNECT on caregiver burden and mood at 3-month follow-up.      Aim 3. Assess the effects of CONNECT on healthcare resource use over 1 year of follow-up.   "
43810|NCT02712216|"     The purpose of this research study is to determine which sites are best suited for     laparoscopic entry of bariatric trocars in the morbidly obese population.   "
43811|NCT02712203|"     Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated     measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in     their second year of life.The purpose of this study is to assess the effect of the age at     administration of the first dose on the reactogenicity and immunogenicity of the measles     component of these vaccines.      In addition, this study will evaluate if the effect of the age at first dose is modified by     the type of vaccine administered.   "
43813|NCT02712177|"     Bexsero™ is a four component serogroup B meningococcal vaccine (4CMenB) licensed in Europe,     Canada, and Australia in 2014. Prelicensure studies and post marketing surveillance data     showed that 4CMenB has a high reactogenicity especially when coadministered with other infant     routine vaccines [1-2]. While this suggests that coadministration causes an interaction     resulting in a greater risk of adverse events following Immunization (AEFI) only the AEFI     after the 4CMenB dose and not those occurring after routine vaccine immunizations were     reported, underestimating the total risk associated with immunization at separate visits. For     financial and practical reasons, coadministration of infant vaccines is preferred to separate     visits. Separate visits may however be preferred if the sum of the AEFI risk at each visit is     significantly smaller than the risk with coadministration and/or if the AEFI has a lesser     severity. The purpose of this study is to recalculate the risk of occurrence and severity of     AEFI with the coadministration of Bexsero™ and routine vaccines compared to separate     injections to assess the interaction occurring with co-administration. Investigators will     also estimate the risk of recurrence of AEFI at subsequent immunizations with the 4CMenB and     assess if this risk varies with separate or coadministration with routine vaccines. To     achieve these purposes, investigators will perform a secondary analysis of the data of three     randomized controlled trials (clinicaltrials.gov identifiers: NCT00657709, NCT00847145 and     NCT00721396) that evaluated 5025 children aged 2 to 14 months of whom 4535 were randomized to     receive 3 to 4 doses of 4CMenB concomitantly or alternatively with routine vaccinations     (DTaP-IPV-HepB/Hib [Infanrix Hexa™], PCV7 [Prevenar™] or MMRV [Priorix-Tetra™]) [1,2].   "
43814|NCT02712164|"     The purpose of this single-center, randomized, prospective cohort study is to evaluate the     clinical outcome and negative-pressure wound therapy (NPWT) mediated modulation of the     biologic milieu of a modified NPWT dressing on split-thickness skin graft (STSG) donor sites.   "
43815|NCT02712151|"     Laparoscopic cholecystectomy is associated with considerable postoperative pain and     surgeon-administered local anesthetic infiltration is the standard practice for achieving     post-operative analgesia. However, recent studies have shown that pediatric patients continue     to experience significant pain during the first 24 hours.      The investigators plan to conduct a prospective, double-blinded, randomized study where     patients will be designated into either a test group receiving an ultrasound-guided     transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and     peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block     with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and     surgical team will both be blinded as well as the research personal in the postoperative     period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing     laparoscopic cholecystectomy will be included.      The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single     shot transversus abdominis plane and rectus sheath blocks, are superior to local wound     infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain     related behavior and facilitating functional recovery.   "
43816|NCT02712138|"     Development of a new mass spectrometry based biomarker for the early and sensitive diagnosis     of a Gilbert disease from plasma. Testing for clinical robustness, specificity and long-term     stability of the biomarker.   "
43861|NCT02711553|"     The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or     merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or     metastatic biliary tract cancer.   "
43818|NCT02712112|"     Recent preclinical study has suggested a potential possibility that imatinib might promote     tumor growth in the presence of secondary resistance mutations [10]. This result imply that     intermittent dosing schedule of imatinib rechallenge might be better than continuous dosing     schedule in terms of controlling tumors harboring secondary resistance mutations. In     addition, in these heavily pretreated patients, even mild grade of toxicity may significantly     impair quality of life, and intermittent dosing schedule may have an advantage in this     context. Therefore, investigators hypothesize that intermittent dosing schedule of imatinib     rechallenge might be feasible and effective in patients with TKI-refractory GISTs. This study     will assess the feasibility of intermittent imatinib dosing schedule in patients with GISTs     who had failures from both imatinib and sunitinib.   "
43819|NCT02712099|"     The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of     morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative     findings.   "
43820|NCT02712086|"     The main objective will be to evaluate the effect at 5 weeks of nutritional management     associated with protein supplementation (adapted to the post-operative period) on the     maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.      Secondary objectives will assess protein intake, food safety, the effect of protein     supplementation on body fat in the entire body and the metabolic rate and the impact on     quality of life and post-operative joint pain.   "
43821|NCT02712073|"     In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold     standard in France for colorectal cancer screening in populations at risk. However, it has a     number of limitations. The quality of the bowel preparation is a critical step for the     successful completion of this examination. The occurrence of interval cancers raises the     problem of missed lesions. A literature review showed that there were differences between the     endoscopy units on quality standards for bowel preparation. The rate of unprepared     colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516     colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate     substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008.     The establishment a predictive score for quality of bowel preparation based on a     self-administered questionnaire completed by patients during the pre-colonoscopy     consultation, would help identify patients at risk of poor preparation in order to optimize     the prescribed preparation in this consultation.   "
43834|NCT02711904|"     Condition of the State: (terminated, recruiting, etc.) Terminated      Study Design: Main Objective:      Compare the frequency and intensity of coughing at the time of extubation with two infusions     of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through     the technique of target controlled anesthesia   "
43822|NCT02712060|"     Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited     connective tissue disorders characterized by joint hypermobility, skin hyperextensibility,     and tissue fragility. EDS features such as genetically related cartilage defects,     craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to     cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires     that EDS patients might be more frequently affected by OSA and sleep disturbances than the     general population. However, the actual prevalence of OSA in children and adolescents with     EDS is unknown.      The primary objective of this study is to assess the prevalence of OSA in children and     adolescents with EDS (25) compared to a matched control group (25). The secondary objective     of this pioneer study is to assess the quality of life in children and adolescents in EDS in     comparison to healthy children and adolescents.   "
43823|NCT02712047|"     For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2     receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric     oxide (FeNO) is a non-invasive airway inflammation marker.      In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose     study, the duration of action of fluticasone furoate (FF) will be determined by monitoring     the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in     asthmatic subjects.      Subjects who meet the eligibility criteria will participate in the following two treatment     periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will     be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be     followed by a 21-day monitoring/washout period before crossing over to the next treatment     period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored     up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).   "
43824|NCT02712034|"     The primary aim of this study is to measure and explain the impact on long-term opioid use     when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health     system (A-CHESS).   "
43825|NCT02712021|"     Lycra garments have recently been used for children with cerebral palsy, with favorable     effects on alignment, biomechanics and neuromuscular activity. The aim of the present study     is to determine the efficacy of a Lycra suit in improving motor function and static balance     in children with cerebral palsy. The children included in this study will be part of a     prospective project on children with cerebral palsy, older than 4 years of age, and their     families regularly followed at the Child Neurology Unit of the Catholic University of Rome.   "
43826|NCT02712008|"     The primary objective of the study is to compare the efficacy of intravitreal     (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in     improving best corrected visual acuity (BCVA) in patients with diabetic macular edema (DME).   "
43827|NCT02711995|"     Botulinum toxin is the common treatment of choice for patients with Essential Voice Tremor     (EVT), but results are not universally beneficial to all patients. Inconsistent results are     noted in the literature and are consistent with the PI's clinical experience. Injection     augmentation, a well-established treatment for glottic insufficiency, which is a prominent     factor in the clinical presentation of Essential Voice Tremor (EVT), has not been studied. By     treating patients at separate times with botulinum toxin and injection augmentation in an     unblinded prospective crossover treatment study, we can assess functional outcomes of these     two treatments with the population of patients with Essential Voice Tremor (EVT).   "
43862|NCT02711540|"     Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke     rates following TAVI are roughly 3%. There are several device and procedure related     characteristics which may increase the risk of stroke. We will examine if there is a signal     in the UK registry. This will be important is TAVI is to be extended down to lower risk     patient cohorts.   "
43828|NCT02711982|"     The pathophysiology of Traumatic Optic Neuropathy (TON) include a primary and secondary     mechanism of injury. At present, no studies validate a particular approach to the management     of TON. There are three management lines for these patients that include 1)observation     only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical     intervention. Studies have shown that forces applied to the frontal bone and malar eminences     are transferred and concentrated in the area near the optic canal. The tight adherence of the     optic nerve's dural sheath to the periosteum within the optic canal is also thought to     contribute to this segment of the nerve being extremely susceptible to the deformative     stresses of the skull bones. In this study, investigators aim to make a randomized controlled     trial to certify the efficiency of optic nerve canal decompression for TON patients.   "
43829|NCT02711969|"     An open study to evaluate the safety of apatinib mesylate (YN968D1) 1,000mg monotherapy in     patients with unresectable locally advanced or metastatic Gastric cancer failed to standard     therapy.   "
43830|NCT02711956|"     This is an open label, non-randomized, Phase 1b, dose escalation and dose confirmation study     of ZEN003694 in combination with enzalutamide in patients with mCRPC.   "
43831|NCT02711943|"     Chronic prostatitis is a common disease in men with the following typical symptoms decreasing     the ability to work and quality of life: pain, urination disorders, copulatory dysfunction.      Following study is conducted to study Levofloxacin in chronic prostatitis.   "
43832|NCT02711930|"     Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in intensive     care units (ICU). This syndrome is associated with high morbidity and mortality. In     management of ARDS patients, lung protective ventilation and prone ventilation are key     strategies which have shown survival benefits in recent years and now become standard part of     care in these patient. Prone positioning used for surgeries in operation room has been     reported with ocular complications, of which vision loss is one of the devastating     complications. There is scarcity of literature on effect of prone positioning on intra-ocular     pressure (IOP) in critically ill patients. The purpose of our study is to evaluate the effect     of prone position on IOP in critically ill patients and follow up for other ocular     complication among survivors.   "
43833|NCT02711917|"     Different concentration of sevoflurane was given to maintain anesthesia. The dose of propofol     to maintain BIS between 40-60 and the consumption of rocuronium was recorded and evaluated.   "
43836|NCT02711878|"     The purpose of this study is to see if exercise is helpful for improving memory,     concentration thinking abilities, physical function, and quality of life for adults aged 50     to 89 years living with HIV and who have two or more cardiovascular disease risk factors. The     study will test two kinds of intervention exercises: one group will walk for exercise and the     second group will stretch for exercise. Members of both interventions will be asked to     participate in one-on-one interviews/assessments, measures of physical functioning, and some     sessions with others who are also enrolled in the study.   "
43837|NCT02711865|"     The main goal of this study is to employ a novel proteomic approach to identify predictive     tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R)     targeted therapy in epithelial ovarian cancer. It is expected that these predictive     biomarkers will be applied to increase the response rate in selected groups of patients.   "
43838|NCT02711852|"     This long-term, continued treatment study will evaluate the long-term safety of duvelisib in     patients with hematologic malignancies that were previously treated with duvelisib in a     previous sponsor-approved study.   "
43839|NCT02711839|"     In order to response the increasing of aging population cause losing ability that need     long-care needs, the project entitled 10-year long-term care program from Executive Yuan in     2007 is carried out to assist economically disadvantaged and disabled elderly to acquire     daily nutrition. Therefore, the long-term care resident's nutritional status got more     attention than before. Out of control in blood glucose will not only increase bed sores and     urinary tract infection in tube feeding residents but also rise medical expenditures. The     nutritional status of long-term care institutions, anyang homes and nursing home are     generally bad in nutrition management due to high cost of nutritional supplements from     foreign imports that cause the burden of families. In this study, we will recruit diabetic     subjects that divide into white sweet potato group (experimental group) and commercial     formula group (control group) by using randomized, parallel and open clinical study through     tube feeding in sixty days.   "
43840|NCT02711826|"     The purpose of this study is:        -  To see if polyTregs and/or donor reactive darTregs can reduce inflammation in a          transplanted kidney.        -  To find out what effects, good or bad, polyTregs or darTregs will have in the kidney          recipient.        -  To find out what effects, good or bad, taking everolimus after polyTregs or darTregs          will have in the kidney recipient.   "
43841|NCT02711813|"     The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in     patients with active Systemic Lupus Erythematosus, not adequately controlled with current     concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and     pharmacodynamic parameters in this study population.   "
43932|NCT02710630|"     The primary objective of this trial is to investigate the relative bioavailability of five     different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1,     Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule     formulation of Dabigatran Etexilate.      The secondary objective is to evaluate and compare several pharmacokinetic parameters between     the treatments.   "
44525|NCT02702908|"     This study aims at estimating the incidence of second primary malignancies as well as the     overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant     prostate cancer (mCRPC) patients not treated with radium-223-dichloride.   "
43842|NCT02711800|"     The investigators seek to conduct the first open-label trial of probiotics in young children     to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the     feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the     middle-lower GI tract. Self-report measures and a laboratory task will be collected from     children, ages 9-13 years of age, and self-report measures from their primary caregivers     prior to and following a 30-day probiotic administration. Children who score above cutoff in     anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited     sample size and the iterative nature of intervention development, criteria for success at the     pilot phase are based primarily on clinical rather than statistical criteria. The study     personnel will do their best to keep and ensure the privacy and confidentiality of our     participants; however, some of the risks of this study may include psychological discomfort,     legal risks, and loss of confidentially.   "
43843|NCT02711787|"     Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an     easily applied innovative solution to rehabilitation, because the hand can perform grasp and     release activities wearing the device by mean of a flexible and light orthosis. Our objective     on this research was to the robotic assisted motion and activity in additional to     physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.   "
43844|NCT02711774|"     Intracranial Pressure ( ICP ) monitoring is an essential component of traumatic brain injured     ( TBI ) patients management. The clinical signs of raised ICP may be unreliable and may     reflect relatively late cerebral decompensation. ICP may be monitored by invasive or non     invasive techniques. While invasive techniques show the real time values of ICP, they are     associated with many complications like, intracranial bleeding and infection, occlusion of     the catheter tip by blood, debris and difficult to locate ventricle in presence of cerebral     oedema. All these drawbacks of invasive methods can be averted by employing non invasive     techniques of ICP monitoring. Although they do not show a real time value but are excellent     tools to detect presence or absence of raised ICP. Elevated ICP can be detected by     Computarised tomographic scan (CT) or Magnetic resonance imaging (MRI) but , these techniques     are time consuming and require transportation of a patients who may be unstable .The quick     and non invasive nature of ultrasonography is fast becoming popular for rapid detection of     elevated ICP at bedside in emergency and ICU by monitoring the optic nerve sheath diameter (     ONSD ). Its limitations notwithstanding, ultrasonographic ONSD monitoring is likely to be     more reliable than clinical assessment in the diagnosis of intracranial hypertension     especially, when patient is under sedation which precludes proper clinical examination.     Therefore, in recent years ,among non invasive methods, bedside ocular ultrasonography to     monitor ICP has gained popularity.      Carbon dioxide being a potent modulator of cerebral vascular tone, alters the ICP by changing     the size of cerebral vasculature and thereby, cerebral blood flow (CBF) and this action     occurs very rapidly, over e period of few minutes. In a range of PaCO2 20mmHg to 80 mmHg the     cerebral blood flow changes in a linear manner. End tidal carbon dioxide concentration(EtCO2)     is a surrogate measure of PaCO2 (especially in a haemodyanimically stable patient with     healthy lungs ) and is routinely monitored continuously in patients subjected to general     anaesthesia. To date there is very little literature on the effects changing EtCO2 on ONSD .     This prompted us to conduct this study to find out the effects of different levels of EtCO2     on ONSD.   "
43845|NCT02711761|"     prospective randomized double-blind controlled study   "
43846|NCT02711748|"     The study aims to assess the regularity of the proceedings in the case of a patient with     bradycardia ECG.   "
43847|NCT02711735|"     Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa     trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant     Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time point     of vaccination starts at 16 weeks upon start of standard MDR-TB treatment (cohort A), and if     clinically safe as evaluated by an independent panel of experts (DSMB), another cohort of     patients will be vaccinated at 12 weeks upon start of standard MDR-TB treatment (cohort B).     All the patients will be followed up 8 weeks after vaccination.   "
43848|NCT02711722|"     Title: Reduced Unloading in NAVA Improves distribution of Ventilation in ICU patients.      Objectives:        1. To investigate if NAVA targeted to moderate respiratory muscular unloading results in          redistribution of ventilation to the dorsal regions of the lungs        2. To verify if the redistribution of ventilation translates to a better gas exchange and          to a potentially lung protective ventilation strategy (lower airway pressures)        3. To verify the possibility to set NAVA at different levels of unloading, based on          Neuro-Ventilatory Efficiency.      Study Design: Randomised Crossover of Pressure Support and NAVA at different levels of     unloading.      Population: Adult Intubated patients at the Neurosurgical ICU, ventilated for more than 48h,     in weaning phase from mechanical ventilation.      Study duration: 2,5h Number of subjects: 12   "
43849|NCT02711709|"     The purpose of this study is to define the natural history and causes of chronic critical     illness (CCI) in surgical intensive care patients who have had sepsis. The investigator wants     to study a sub-population of sepsis patients that have intra-abdominal sepsis. The purpose of     this research study is to define the acute changes in frailty (weakness, slowness, loss of     muscle mass), comorbidity (medical problems) and disability (difficulty with mobility and     performing routine daily functions) after having an infection that is located in the     abdominal cavity or torso. The investigator believes having severe infection contributes to     acute and permanent changes in these areas, especially in those of advanced age.   "
43850|NCT02711696|"     The study assessed whether compete healing of duodenal mucosa in celiac patients with     persistent Marsh I-II lesion after 1 year of gluten free diet (GFD):        -  could be achieved by adoption of a diet based exclusively on naturally gluten free          products, with the elimination of commercially available processed food (GCED, Gluten          Contamination Elimination Diet);        -  may depend upon time of exposure to GFD.      Investigators studied two cohorts of celiac patients, both on GFD, for at least one year:        -  cohort A: patients re-biopsied after three months on GCED;        -  cohort B: patients re-biopsied after a minimum of further two years on standard GFD.   "
43895|NCT02711111|"     Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or     both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally     treated with a protraction facemask in order to stimulate forward growth of the upper jaw.     This treatment option is often inducing unwanted side effects including mesial migration of     the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects     are often difficult to achieve with this approach, more pronounced class III malocclusions     cannot be addressed by face mask therapy. These children cannot be treated during childhood     and end up in major orthognathic surgery at full-grown age. To be able to treat also the more     pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment     methods were developed which uses skeletal anchorage.   "
43851|NCT02711683|"     Alzheimer's disease (AD) is the commonest cause of dementia. There is no effective treatment     to cure the disease. Cholinesterase inhibitors, such as donepezil, are widely recommended to     patients with mild to moderate AD. But the cognitive function of most of the patients using     donepezil gradually aggravate, with Mini-Mental State Examination(MMSE) score falling by 2     points per year on average, and donepezil cannot effectively delay AD progress.      DL-3-n-butylphthalide(NBP) is a synthetic chiral compound containing L- and D-isomers of     butylphthalide. It is developed from L-3-n-butylphthalide, which was initially isolated as a     pure component from seeds of Apium graveolens in 1978 by researchers of Institute of Medicine     of Chinese Academy of Medical Sciences. Studies in the past several decades have demonstrated     that NBP is effective in alleviating oxidative damage and mitochondria dysfunction, improving     microcirculation. NBP was approved by the State Food and Drug Administration of China (SFDA)     as a therapeutic drug for treatment of ischemic stroke in 2005 Not only for ischemic stroke,     NBP has been reported to increase the expression of N-methyl-D-aspartate subtype glutamate     receptor 2B(NR2B) and synaptophysin in hippocampus of aged rats after chronic cerebral     hypoperfusion and increasing brain acetylcholine level, which are important processes     involved in learning and memory. It could alleviate the learning and memory deficits induced     by cerebral ischemia in rats. A multicentre, randomized, double-blind, placebo-controlled     trial conducted by Professor Jia investigated that NBP was effective for improving cognitive     and global functioning in patients with subcortical vascular cognitive impairment without     dementia and exhibited good safety over the 6-month treatment period. The pathogenesis of AD     involved mitochondria dysfunction and microcirculation dysfunction, which are the action     targets of NBP. Investigators observed that MMSE score lowering slowly when using NBP     treatment in patients with mild to moderate AD already receiving donepezil. But investigators     lack of system evaluation and follow-up. Hence, investigators hypothesized that NBP may have     therapeutic efficacy for patients with AD and designed the present study.   "
43852|NCT02711670|"     Thiazide diuretics will be more effective in lowering urine calcium excretion if taken at     night as compared to the daytime. It will therefore be more effective in reducing kidney     stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to     have increased risk of kidney stones at night time.   "
43853|NCT02711657|"     To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and     severe asthma and healthy controls.   "
43854|NCT02711644|"     Research has shown that a woman's lifestyle during pregnancy can predict the future health of     a mother and her child. Improving the health of a mother during pregnancy can lead to the     best health outcomes for mother and child in the short and long-term period. Currently there     is a lack of understanding about how best to support women to achieve healthy weights during     pregnancy. The aim of this study is to understand if additional lifestyle support, such as     discussions about healthy eating and physical activity provided by a healthcare provider     throughout pregnancy can help women achieve weights concordant with gestational     recommendations.      The healthcare providers in this study will be Registered Dietitians (RD). The intervention     RD will be trained in Healthy Conversations, a supportive method of communication that     utilizes open-ended questions to support patient-centered behaviour change. This allows women     to explore health issues, identify barriers and discover solutions for improving their own     health. This supportive prenatal counselling will occur with the intervention group     concurrently while completing lifestyle questionnaires with the study RD. During these     conversations, health goals will be made and will be followed up at future visits. The     control group will complete the lifestyle questionnaires with the control RD; they will not     receive additional lifestyle support at these visits. Women will be randomized into one of     the two study groups and will be blinded to their study allocation. All participants will     complete two in person visits and two follow-up telephone calls. Data will be collected on     diet, physical activity, gestational weight gain, delivery, and infant outcomes.      After this research is complete, the investigators hope to better understand the quantity and     quality of additional support that may help women in Alberta achieve guideline concordant     weight gain during pregnancy. If interventions can help women gain weight within the     guidelines, pregnancy-related complications can be reduced. This information is also aimed at     providing a better understanding of healthcare system requirements (i.e., type of providers     and care model) in supporting women achieve healthy weights in pregnancy. The findings from     this project have the potential to improve prenatal healthcare delivery across the province.   "
43855|NCT02711631|"     Regular exercise in patients who have heart disease is highly beneficial and improves quality     of life and survival. Exercise training is considered a core component of cardiac     rehabilitation (CR), which is a multicomponent program delivered to patients who have heart     disease. However, it is severely underutilized because people simply don't have the time or     the resources to travel to a CR centre to attend rehab appointments.      The investigators have developed a novel virtual reality (VR) based CR exercise system     (MedBike). This system consists of an exercise bike attached to a VR world; it makes exercise     engaging and fun. Furthermore, patients can be monitored during exercise remotely over the     internet. The investigators intend to perform a pilot randomized controlled trial in which 10     patients are assigned to the MedBike system and 10 to standard CR. The investigators think     that the MedBike system will increase exercise program compliance by providing an enjoyable     and engaging exercise experience which can be performed in the comfort of one's own home. The     investigators think that this will improve fitness (primary endpoint) in these patients. If     the investigators demonstrate that home based exercise is feasible, the investigators plan a     larger study to prove that it is something that should be broadly implemented in patients     with heart disease.   "
43856|NCT02711618|"     Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape     contour I V3 for non-invasive fat reduction.      The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the     abdomen.   "
43857|NCT02711605|"     Male volunteers who suffer from Pseudogynecomastia and seek noninvasive breast fat reduction     will be enrolled into two arms to receive three biweekly UltraShape treatments.   "
43858|NCT02711592|"     The objective of this study is to see how pain management and its outcomes are effected when     pharmacogenomic testing is used to determine patient specific pain medication and dosing. Our     goal is to determine if through the use of analgesic genetic testing, TKA post-operative     patients will see a decrease in narcotic consumption, postsurgical opioid- related adverse     reactions, and length of stay, overall NRS pain scores and while maintaining or improving     their satisfaction scores.   "
43859|NCT02711579|"     the purposes of this study are to evaluate the acute electrophysiological response in brain     cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the     electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg     twice-daily for 7 days) in healthy volunteer   "
43860|NCT02711566|"     Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke     survivors. Robots can be programmed to interact with patients by guiding their movements, by     monitoring their performance and by quantifying the type and degree of their impairment.      A distinctive element of multiple sclerosis is the involvement of a variety of functional     systems, in a way that is highly subject-specific. This requires a personalization of     treatment, and continuous adaptation to changes in condition. This points to a need for     integrating patient assessment, definition of rehabilitation protocols, their administration     and the assessment of their outcome.      The goal of this study is to assess, in persons with MS, the efficacy of a type of     robot-assisted training that was specifically designed to counteract incoordination and     muscle weakness (typical of MS), tailored to individual type and degree of impairment, when     compared to simple movement training.   "
43863|NCT02711527|"     This is a randomized, open-labelled study to study the effect of the different acupoints     combination under TCM treatment principles by fNIRS.      The investigator aim to recruited 36 depression subjects and go through 6 acupuncture     treatment sessions in 3 weeks. They will be divided into 2 groups by randomization. (Group A     n=18, Group B n=18) The participants will receive 2 acupuncture session per week for 3     consecutively weeks. In each treatment session, all subjects in both groups will receive the     same amount of needle insertion ( total 14 needles) , all needles will be retained for 30     minutes. The whole treatment will last for around 45 minutes. No sedation will be conducted.      Subjects in Group A will receive 14 needles based on the TCM theory Soothing liver-qi     stagnation, all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝     (LR 3), Ligou蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan膝關 (LR 7), Ququan曲泉 (LR 8), Zhangmen章門(LR13),     Qimen期門 (LR14).      Subjects in Group B will receive 14 needles based on the TCM theory Soothing liver-qi     stagnation and Tonifying the heart and the spleenand Invigorating the Yang Qi, all     needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), ,     Sanyinjiao 三陰交 (SP 6), Xuanzhong懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui     百會(DU 20), Shenting神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu     (abbreviation: TDP) 特定電磁波譜 will be applied to Group B immediately after the needle     insertion. This TDP device is a infra-red heat lamp which is commonly used by acupuncturists     and Chinese Medicine Practitioner as a therapeutic substitute for moxibustion. The procedure     will be lasted for 30 minutes in 30-40 cm above the specified acupoint Qihai 氣海(RN6) and     Guanyuan 關元(RN4).   "
43864|NCT02711514|"     Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs     published literature   "
43865|NCT02711501|"     The aim of this study was to investigate if using lasers instead of scalpel for flap     advancement in bone augmentation procedures would reduce post-operative swelling and pain.   "
43866|NCT02711488|"     The objective of the project is to develop, implement and evaluate a prevention program for     obesity among adolescents in Brazil combining the primary care health system implemented in     the country in recent decades with primary prevention at schools.   "
43867|NCT02711475|"     Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal     polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or     carcinoma in this kind of polyps is very low, a remove and discard technique has been     proposed.      The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes     equipped with high definition, magnification and optical filters.   "
43868|NCT02711462|"     This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator     blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation     study in healthy subjects, females of non childbearing potential and males between the ages     of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7     cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are     anticipated in the Multiple Dose (MD) portion of the study.      Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and     2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety     and tolerability. FDA review and agreement to move forward will take place before the     remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.      A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The     duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include     weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two     doses).   "
43870|NCT02711436|"     The aim of the study is to compare orbital and central nervous system (CNS) imaging with     Computed Tomography (CT) scan to that of Fast Magnetic Resonance Imaging (Fast MRI) in     children with mild, moderate or severe orbital cellulitis with medical indications for     imaging.   "
43871|NCT02711423|"     This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in     healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a     single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly     assign participants to receive a single open-label SC dose of ganenerumab at different dose     levels according to safety assessments from Part I.   "
43872|NCT02711410|"     Background:      Clopidogrel, an antiplatelet prodrug, is widely used for prevention of the recurrent     cardiovascular events. CYP2C19 is one of the crucial enzymes for the activation of     clopidogrel. Recent studies, mostly done in cardiovascular patients, showed association of     the CYP2C19 genotypes with recurrent cardiovascular events. However, prospective data on the     impact of the genetic variants in stroke patients are limited.      Methods:      Five hundred and eighteen Japanese non-acute stroke patients treated with clopidogrel were     registered at 14 institutions. Three CYP2C19 variants (CYP2C19*2, *3, *17) were genotyped and     the patients were classified into three clopidogrel metabolizer groups inferred from the     CYP2C19 genotypes: extensive (EM: *1/*1), intermediate (IM: *1/*2 or *1/*3), and poor (PM:     *2/*2, *2/*3, or *3/*3). The CYP2C19*17 carriers were excluded from the analysis. The     antiplatelet effects of clopidogrel were assessed by Adenosine diphosphate (ADP) -induced     platelet aggregation and vasodilator-stimulated phosphoprotein (VASP) phosphorylation,     expressed as VASP index. The endpoint was the composite incidence of stroke, transient     ischemic attack, myocardial infarction, revascularization, other thromboembolic disease, or     cardiovascular death during 2 years of follow-up.   "
43873|NCT02711397|"     Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients     should be followed-up with dietary interviews and serologic tests for CD markers to ensure     adherence to the diet. However, none of these methods offer an accurate measure of dietary     compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in     stools as a marker of GFD adherence in CD patients and compare it with traditional methods of     GFD monitoring.      We performed a prospective, non-randomized, multicentre study including 188 CD patients on a     GFD and 73 healthy controls on a gluten-containing diet. Subjects were given a dietary     questionnaire and fecal GIP quantified by ELISA (iVYLISA GIP-S kit). Serological anti-tissue     transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies     were measured simultaneously.   "
44526|NCT02702895|"     MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize     qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore     socio-contextual and trial specific issues which affected participants' adherence to the     dapivirine vaginal ring (VR).   "
43874|NCT02711384|"     Introduction: Sevoflurane is the most volatile anesthetic used during CPB. In addition to the     cardioprotective effect, Sevoflurane also promotes reduction in systemic vascular resistance     and also an important role in anesthesia maintenance during surgery, preventing patients     awaken in the intraoperative. To avoid the awakening during surgery, assessment of the level     of consciousness through the bispectral index (BIS) has been the most common method used by     anesthesiologists. During cardiac surgery the most critical moment may be the patient is     awaken during the warm up phase of CPB. The monitoring of this phase with the BIS has become     efficient as to alert the anesthetist that the patient may be waking up.      Aims: The primary endpoint of this study is to determine the ideal minimum dose of     sevoflurane (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery     have no intraoperative awareness.      Methodology: Dixon's up-and-down technique is a commonly used method to define MAC (27-30).     The anesthetic concentration applied to the first patient is estimated by clinical     experience. If there BIS values below 50, the concentration of inhalational anesthetic in     subsequent patient is decreased by 20%. If the BIS show values greater than or equal to 50     for a period ≥ 1 minute steadily, the concentration is increased by 20% in the next patient.     In each series of patients, the pairs of independent cross in order measurements are     identified. Logistic regression is used to determine the ideal minimum dose of sevoflurane     (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery have no     intraoperative awareness.   "
43875|NCT02711371|"     The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and     how social and emotional brain function are altered in dependent cannabis users relative to     healthy non-using control subjects after a 28 supervised abstinence period. Previous research     in cannabis users has predominantly focused on cognitive functions. Moreover, studies have     implicated that observed deficits in cannabis users may regenerate after a prolonged     abstinence period. Findings might provide important information with respect to relapse     vulnerability.   "
43876|NCT02711358|"     The aim of the investigators study is to test the analgesic effect of rectal indomethacin     during Intrauterine device insertion.   "
43877|NCT02711345|"     A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway     alterations.   "
43878|NCT02711332|"     This is an open, single-centre trial investigating the impact of haemolysis after capillary     blood collection to the measured potassium concentration in Plasma healthy subjects. Each     subject will have four capillary blood collections on different fingers. Two on the right and     two on the left hand. Additionally as a reference a venous blood collection will be     conducted.   "
43879|NCT02711319|"     to optimize the functional outcome in early phase of gait rehabilitation in subacute     incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to     gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger     improvement of gait function than with physical therapy alone.   "
43880|NCT02711306|"     Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical     features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired     glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of     pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary     fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat     concentration, and weight management, and has other health benefits.The purposes of this     study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and     diabetic patients.   "
43881|NCT02711293|"     Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the     potential to reduce key barriers to ART care retention. The primary endpoint of this trial is     the effect of CHW-led home delivery of ART on the proportion of patients with a suppressed     HIV viral load after six months follow-up. This is a cluster-randomized controlled trial set     in Dar es Salaam's Temeke district. The unit of randomization is a healthcare facility with     its surrounding neighborhoods. We matched all 18 healthcare facilities offering ART services     in Temeke district into pairs based on having a similar number of patients currently on ART.     In each pair, one cluster was randomized to the intervention and one to the control arm. The     intervention consists of monthly home visits by CHWs to provide counseling and deliver ART to     patients who are stable on ART, while the control is the standard of care (facility-based ART     care and CHW home visits at least every three months without ART home delivery). In addition,     within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led     nutrition counseling and half to standard counseling.   "
43882|NCT02711280|"     The purpose of this study is to determine whether Propofol and Sevoflurane affect the     oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.   "
43883|NCT02711267|"     The overall aim of this clinical study is to investigate the ability of dermal open flow     microperfusion to assess bioequivalence and non-bioequivalence of acyclovir formulations in     the skin of healthy volunteers.   "
43884|NCT02711254|"     The purpose of this study is to evaluate improvement in pain and function following     implantation of a new device, called the Phantom Knee System, in patients needing unloading     of the medial compartment of the knee   "
43885|NCT02711241|"     The purpose of this study is to find out an optimal way of analgesia in case of acute     infectious gastroenteritis the investigators are going to compare two medicines that are used     on everyday basis (without being ever before subject to scientifical study): Dipyrone and     papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of     treatment is included in study   "
43908|NCT02710942|"     The goal for this pilot study is to assess the acceptability of two online self-guided     programs for migraines. The programs are part of the investigators' collection of my     Wireless Headache Interventions (myWHI). The Specialized Program for Headache Reduction     (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage     headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users     to discover their headache triggers and provides recommendations for managing them. This     pilot will also assess the feasibility of the study protocol to inform a full scale     randomized controlled trial (RCT).   "
43886|NCT02711228|"     The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous     injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune     deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL)     evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to     determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK     outcomes on weekly and biweekly IgPro20 therapy.      Patients who have received and/or are currently receiving immunoglobulin G (IgG) in     intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet     inclusion/exclusion criteria.      The study consists of two parts. In Part 1 of the study enrolled subjects will receive     IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24     weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly     treatment with IgPro20 for 52 weeks, for both groups.      Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a     PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.   "
43887|NCT02711215|"     Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft     and are the current first line of pharmacological antidepressive treatment. Yet, there is a     missing link between this first molecular step in their mechanism of action and observed     clinical improvement. We have determined to establish a framework combining genuine molecular     and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human serotonergic system     in order to predict antidepressant treatment response.      Objectives:        1. To predict antidepressant treatment response from data obtained using hybrid PET/MR with          acute pharmacological challenge.        2. To discriminate healthy from depressed subjects using this paradigm.        3. To establish models connecting regional changes in occupancy of serotonin transporters          (5-HTT) following citalopram infusion, with changes in brain activation and connectivity          of major resting-state hub networks.      Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.      Materials and methods:      40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS     mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural     imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a     bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT     occupancy with drug challenge, applied after 70min, in a single session. Scanning will be     terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment     with repeated evaluation of response for 3 months.   "
43888|NCT02711202|"     The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on     two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade     (infliximab) monoclonal antibodies in the early posttransplant period followed by either     monotherapy based on tacrolimus or sirolimus.   "
43902|NCT02711020|"     The purpose of this study is to perform an efficacy study of Personal Construct Therapy,     which focuses on the construction of self and others, for women diagnosed with fibromyalgia     who have also comorbid depressive symptoms. To that aim, it will be compared with Cognitive     Behavioral Therapy, which is an already well-established treatment in this area.   "
43915|NCT02710851|"     This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the     novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO.,     LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would     be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo     vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6     month schedule. This is a double-blind study.   "
43889|NCT02711189|"     Background:      Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may     affect how the body responds to alcohol. Researchers believe oxytocin may be a possible     treatment for alcoholism.      Objective:      To test whether the hormone oxytocin affects the brain reward system. To see if it affects     how people respond to alcohol and other rewarding things in life like food and seeing loved     ones.      Eligibility:      Men ages 21-55 who have an alcohol use disorder.      Design:      Participants will have two 6-day inpatient study visits. They will have:        -  Study medication or placebo given twice daily as a nasal spray.        -  Height and weight measured.        -  Medical history.        -  Blood and urine tests.        -  Breath tested for alcohol.        -  Electrocardiogram.        -  An alcohol administration session. In a bar-like room, where participants will consume          four alcoholic drinks.        -  Magnetic resonance imaging (MRI). The MRI scanner is a metal cylinder in a strong          magnetic field. Participants will lie on a table that slides in and out of the cylinder.          A device called a coil will be placed over their head. Participants will complete tasks          on a computer screen.        -  In another alcohol session. they will drink an alcoholic beverage then answer questions.          Participants will get a tab for eight more drinks ($3.00 per drink). They may drink any          of the drinks or take the money. Participants will hold and smell a glass of water and          their favorite alcoholic drink.        -  Heart rate and blood pressure will be monitored.        -  Saliva samples will be collected        -  Computer tasks and questionnaires.      About one week after the end of visit 2, participants will return to clinic for a follow-up     visit. Symptoms and side effects will be evaluated.   "
43890|NCT02711176|"     This study is conducted to investigate whether the efficacy of single-dose triple therapy     (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to     double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the     treatment of H pylori infection.   "
43891|NCT02711163|"     The aim of this study is to assess the hypoallergenicity of a new thickened extensively     hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a     double blind placebo controlled food challenge, followed by a 3-month open feeding period.   "
43892|NCT02711150|"     The purpose of this study is to assess whether application of an epidural positioning device     to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target     area for neuraxial needle insertion. Lumbar ultrasonography will be performed in 30 pregnant     women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural     positioning device applied. For each position, the size of the 'target area', defined as the     visible length of the posterior longitudinal ligament will be measured at the L3-L4     interspace.   "
43893|NCT02711137|"     This is an open-label, dose-escalation/dose-expansion study of INCB057643 in subjects with     advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or     a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further     evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in     select tumor types including solid tumors, lymphomas and other hematologic malignancies.   "
43894|NCT02711124|"     The aim of this study is to evaluate whether increased level of hemoglobin A1c (HbA1c)     correlates to higher level of platelet reactivity assessed by impedance aggregometry in     patients with diabetes mellitus undergoing elective coronary artery bypass grafting (CABG).   "
43909|NCT02710929|"     Specific Aims:        1. To find the genetic variations associated with spatial working memory performance in          patients with ADHD by using genome-wide association studies (GWAS);        2. To find the genetic variations associated with spatial working memory performance in          healthy subjects by using GWAS;        3. To recruit a validation sample and to replicate the findings from the initial GWAS;        4. To test whether genetic variations significantly associated with spatial working memory          are also associated with ADHD.   "
43896|NCT02711098|"     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for     250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of     life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the     initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the     improvement of mortality and neurological outcome has been achieved over the last decade     thanks to the systematic implementation of a period of targeted temperature control between     32 and 34 ° C in patients who benefited from the realization of at least one electrical     external shock.      There are theoretical and clinical arguments to think that achieving the same way a period of     targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest     with a non- shockable rhythm on arrival can also benefit from this procedure. However other     arguments are against this hypothesis including an increase in the risk of infection ,     worsening of the patient's hemodynamic status with no benefit to him. To answer this     question, we conduce a randomized multicenter study testing the potential improvement of     neurological outcome through this procedure targeted temperature control between 32.5 and     33.5 ° C in these patients.      IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two     temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in     non-shockable rhythm.   "
43897|NCT02711085|"     This study will explore the contribution of stress-system activity to pain and functional     disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of     symptoms after 3, 6 and 12 months post-injury.   "
43898|NCT02711072|"     SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice     to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative     analgesia. high incidence of side effects was noted. is there any alternative?   "
43899|NCT02711059|"     The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism     (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be     useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after     biochemical cure of pHPT.   "
43900|NCT02711046|"     Long standing oral submucous fibrosis(OSMF) is associated with involvement      of the oral submucosa and the muscles of mastication leading to difficulty in mouth      opening. Various surgical modalities are mentioned for release but each has its own     limitations.The aim of the study was to evaluate the change in mouth opening in patients of     OSMF after excision of fibrous bands followed by coronoidotomy and surgical defect coverage     by single stage nasolabial flap.   "
43901|NCT02711033|"     This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy     with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric     cancer and compares the early results of this procedure with open total gastrectomy.   "
43903|NCT02711007|"     After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade     osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored     apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure     of first-line or second-line chemotherapy. Patients >14 years, progressing after standard     treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression     or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4     months. Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR),     defined as no progression at 4 months and safety.   "
43904|NCT02710994|"     This is a randomized, open-label, two-way crossover study to investigate the     pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and     Losec in Healthy Male Volunteers   "
43905|NCT02710981|"     This is a prospective self controlled clinical trial. Women with clomiphene Citrate failure,     and thin endometrium were recruited (N = 42). In their 6th (Clomiphene citrate only) cycle,     women continued on Clomiphene citrate 100 mg/ day for 5 days, and had sonographic measurement     of their endometrial thickness , and Doppler evaluation of their uterine arteries on the day     of HCG administration. In 7th cycle, women (N = 36) were given usual dose of Clomiphene     citrate supplemented with sildenafil vagina gel (5 gm, containing 50 mg sildenafil) twice     daily from cycle day 8 till the day of HCG injection. Endometrial thickness and uterine     artery Doppler were measured on the day of HCG administration.   "
43906|NCT02710968|"     Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal     membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that     minimize ventilator-induced lung injury, morbidity and mortality rates for babies with     congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of     prenatal lung compression and the subsequent impairment of pulmonary function following     delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate     the severity by relating the circumference of the lung contralateral to the hernia to the     fetal head circumference lung to head ratio (LHR) and by noting the degree of upward     herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR),     prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While     overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR <25% is     associated with survival between 11-24%.      The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore     adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal     egress of lung fluid during pulmonary development leading to increased lung tissue stretch,     increased cell proliferation, and accelerated lung growth. European colleagues have developed     intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal     balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group     published summary results of FETO showing an improved survival in 175 patients with isolated     left CDH from 24% to 49%. Our goal with this pilot study is to study the feasibility of     implementing FETO therapy in the most severe group of fetuses with left CDH (O/E LHR < 30%).     which will be considered in two subgroups. Those with and O/E LHR <25% (severe group) and     those with an O/E between 25 to <30% (less severe group).   "
43907|NCT02710955|"     The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation   "
43929|NCT02710669|"     Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two     compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will     randomize participants to (R)-propafenone, (S)-propafenone, or placebo.   "
43910|NCT02710916|"     Glaucoma is the first cause of irreversible blindness worldwide with more than 60 millions     people affected in 2010. It is defined as a neurodegenerative disease characterized by a     progressive loss of retinal ganglion cells (RGC), visual field deterioration and optic nerve     excavation. Intraocular pressure (IOP) is the most common risk factor. Despite its severity,     its impact on quality of life and an existing treatment that can delay visual field damages,     there is no recommended strategy to screen the disease. Clinical evaluation of optic nerve     head excavation performed either by ophthalmologists or glaucoma specialists is highly     inter-observer dependent and limits its accuracy to diagnose glaucoma. Additionally, up to 30     to 40% of nerve fiber layer may be lost before detecting first visual field defects, thus     making this tool not accurate enough for screening purposes.      Spectral-Domain Optical coherence tomography (SD-OCT) imaging technology allows precise and     reproducible measurements of optic nerve head structures and retinal layers mainly related to     the speed of acquisition and an axial resolution of 5 microns. New SD-OCT parameters have     been developed to improve its diagnostic accuracy for glaucoma disease. The investigators     therefore investigate performances of SD-OCT to discriminate glaucoma patients and controls.     All subjects will undergo SD-OCT imaging (Spectralis™ OCT, Version 6.3, Heidelberg     Engineering, Germany) and other study procedures in one single visit. All examinations     performed on the subjects are non-significant risk.   "
43911|NCT02710903|"     A maximum of 220 subjects with a minimum of 25 years will be recruited and examined for this     1-7 visit, up to 35 days research study: Subjects will be genotyped to identify variants of     the interleukin-29 (IL29) and interleukin-28B (IL28B) genes and placed in one of the 4     groups: 50 subjects with dominant allelic variants with healthy periodontium, 50 subjects     with dominant allelic variants with periodontitis, 50 subjects with IL29 (rs30461) or any of     IL28B (rs11083519; rs8105790; rs8099917) single nucleotide polymorphism's (SNP) variants and     healthy periodontium, and 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519;     rs8105790; rs8099917) SNP variants and periodontitis. Visits will consist of outpatient     procedures including oral examinations, oral prophylaxis or periodontal scaling and root     planing, collection of gingival crevicular fluid, dental plaque, saliva, and blood samples.     Analysis will include salivary DNA isolation and pyrosequencing to determine IL29 and IL28B     genotype, mediator analysis of gingival crevicular fluid, dendritic cell differentiation and     inflammatory mediator analysis, and whole-genome shotgun sequencing plaque analysis. Clinical     outcomes will include measurements of periodontal disease progression and inflammation, such     as clinical attachment level (CAL), pocket depth (PD), bleeding on probing (BOP), gingival     index (GI), and plaque index (PI).      Primary Objective: To determine the impact of IL29 and IL28B SNP variants on periodontal     disease expression and local inflammatory response during stent-induced biofilm overgrowth.      Secondary Objective: To evaluate in vitro the impact of IL29 and IL28B SNP variants on     cell-mediated, innate inflammatory response.   "
43912|NCT02710890|"     EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of     intravenous (iv) Lacosamide (LCM) in pediatric subjects >= 4 to < 17 years of age with     epilepsy.   "
43913|NCT02710877|"     The study aims to determine whether the use of automated intermittent devices for labor     analgesia could prevent the increase of instrumental deliveries, with same analgesia.      Moreover it will evaluate if automated devices can allow a reduction of health-care burden.   "
43916|NCT02710838|"     The gastric cancer is the second most frequently diagnosed cancer and the third leading cause     of cancer death in China.80%-90% patients were detected at middle and later stage.The     five-year survival rate for advanced gastric cancer patients is less than 10% due to the     shortage of effective treatment method.The five-year survival rate for early gastric cancer     patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do     not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main     method for confirming gastric cancer.But it is limited to identify early gastric cancer and     it leads to the low diagnostic rate of early gastric cancer.      Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric     cancer, since the first report in the 1990s, people have been exploring in this field.     Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it     makes mucosal lesions highlight,and avoids the interference of background light.If specific     target molecular is linked to the contrast medium,the specific imaging of the lesion can be     presented. What is more,due to the strong penetration power of infrared light,its imaging     depth also increases significantly.Indocyanine green had also been demonstrated safe in     clinical studies and widely used. On this basis,we apply for the research about near-infrared     endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared     endoscopy to diagnose early gastric cancer and clinical value.   "
43917|NCT02710825|"     Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by     EVENDOL scale surgery on children with congenital heart disease   "
43930|NCT02710656|"     A randomized multicentric study for endovascular treatment of patients with obstructive     disease in the SFA (superficial femoral artery) and in the popliteal artery.   "
43931|NCT02710643|"     Phase II prospective multicenter study for stage I/II Follicular Lymphoma treated with     involved-field radiotherapy (IFRT) at doses of 24 Gy) with or without Ofatumumab for 8 weekly     doses on molecular basis. Patients with positive basal Bcl-2 will be followed every 3 months     and with Bcl-2 detection every 6 months for 3 years. Patient with negative basal Bcl-2 will     be followed every 3 months without further Bcl-2 detection.      Ofatumumab treatment will be administered to:        1. Patients with positive basal PCR for Bcl-2-IgH rearrangement in BM and/or PB, resulting          still positive after IFRT;        2. Patients with positive basal PCR for Bcl-2-IgH in   "
43918|NCT02710812|"     The proposed study is an observational, prospective, multicenter study of patients undergoing     neoadjuvant therapy for medium-low rectal cancer.      Recently the investigators have published the findings of a multicenter Italian phase II     study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in     patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy     (pCRT), showed a major clinical response and underwent a transanal local excision. Based on     these results, an organ-sparing approach for patients showing a major clinical response is     feasible without reducing the good results obtained with the standard treatment. While a     phase III trial is the best way to compare the standard treatment with the organ-sparing     approach (local excision or wait-and-see) it is impracticable and likely unethical. An     observational study is therefore one of the best way to evaluate the impact that an     organ-sparing approach may have on oncological outcomes, quality of life, and bowel function     for patients with rectal cancer who, after a pCRT, show a clinical major/complete response.      This phase II trial is designed to test the hypothesis that conservative treatments, in     patients with low-mid rectal cancer who undergo a major or complete clinical response after     neoadjuvant treatment, will be safe and effective compared to standard surgery.      The investigators will compare rectum-sparing approaches to standard surgery, firstly in     terms of rate of organ preservation at 2 years. Additionally they will compare survival     outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete     response, correlation between major and complete clinical response.      To add value, the investigators will measure QoL in patients treated with rectum-sparing     approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal     amputation).      Rectum-sparing approach can be considered clinically acceptable if percentage of conservation     of the rectum at two years is not less than 50%.      The collected data on 164 patients who underwent rectum-sparing allow to test the     hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial     test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it     obtains a frequency of conservation of the rectum of not less than 87 cases.      The analysis results will be reported in accordance with STROBE guidelines (von Elm et al.,     2008). For all analyzes, continuous variables are described using the mean and standard     deviation of position and appropriate measures when appropriate. Categorical variables will     be described using the contingency tables.   "
43919|NCT02710799|"     The aim of this study is evaluate the effects of telephone teleconsultations to primary care     physicians (compared to the state's referral protocol) in the referrals waiting list for     endocrinological appointments.   "
43920|NCT02710786|"     To evaluate effect on comorbid disease and weight loss five years after Roux-en-Y gastric     bypass (RYGB) surgery for morbid obesity.   "
43921|NCT02710773|"     Gait impairment is a common cause of disability in patients who have experienced a stroke and     recovery of walking is a priority goal. Gait outcome is a significant factor that influences     a patient's chance of returning to the social life activity and rehabilitation is an     effective treatment for restoring gait in these patients. Learning to walk backwards     correctly has been recommended to improve the movement components required for walking     forwards. Several studies demonstrated that during backward walking the muscle activity is     higher, more oxygen consumption, metabolic and cardiorespiratory activity are required and     the same motor program is used comparing to during the forward walking. It has been suggested     that backward walking therapy may be promoted as a treatment strategy to improve gait in     stroke patients.      The main goal of this project is to investigate the effectiveness of the backward walking     therapy on gait improvement and spasticity in post stroke patients.   "
43922|NCT02710760|"     The purposes of this study are (1) to determine whether child nutrition-focused adoption     encouragement messages focused on Quality Protein Maize (QPM) and the availability of small     quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for     young children, and (2) to determine whether consumption encouragement messages and     techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to     and health outcomes for young children.   "
43923|NCT02710747|"     To value the accuracy of the dosing algorithm published by the International Warfarin     Pharmacogenetics Consortium in Chinese patients after heart valve replacement.      To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose     and actual dose in the Chinese patients.   "
43924|NCT02710734|"     The aim of this study is to evaluate a risk-adapted approach to the treatment of muscle     invasive bladder cancer. Each baseline transuretheral resection of bladder tumor (TURBT)     sample will be sequenced while proceeding with neoadjuvant accelerated methotrexate,     vinblastine, doxorubicin, and cisplatin (AMVAC) chemotherapy. Based on the mutational profile     and the post AMVAC TURBT findings, patients will be treated with active surveillance     (experimental arm), or standard of care intravesicle therapy, chemoradiation or surgery. We     hypothesize that this approach will lead to non-inferior metastasis-free survival at 2 years,     while preserving the bladder and thus quality-of-life for a proportion of patients.   "
43925|NCT02710721|"     The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a     supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high     metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life,     reduction of side effects and possible reduction in tumor progression.   "
43926|NCT02710708|"     The primary objective is to assess the safety profile of YAZ in Chinese women, including     adverse drug reactions (ADRs).      The secondary objectives are to investigate the rate of unintended pregnancies, the cycle     control for subjects with and without preceding abortion, the bleeding pattern of subjects     with and without preceding abortion (including the abortion-related bleeding pattern) and the     efficacy in moderate acne vulgaris.      Another objective is to investigate the effect on dysmenorrhea.   "
43927|NCT02710695|"     Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little     evidence exists about orthopaedic patient understanding of the common methods of managing     musculoskeletal pain. Therefore, it is our aim to determine which discussion method best     improves patient comprehension of common methods of managing pain.   "
43928|NCT02710682|"     Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent,     painful syndrome of the elbow. It is refractory to conservative treatment measures, including     rest, excentric and concentric exercises in approximately 20% of patients after 6 months.     Corticosteroid injections can provide relief in the short term. Mini-open surgery may be     proposed when the conservative treatment fails and studies have shown an efficacy of 70%.     Ultrasound-guided tendon fenestration is a minimally-invasive technique which stimulates the     physiological healing mechanisms of the tendon and appears promising for the treatment of     chronic tendinopathies. To our knowledge, no studies have compared the US-guided fenestration     technique to mini-open surgery for the treatment of chronic lateral epicondylosis.      The primary objective of this pilot study is to compare the efficacy of US-guided     fenestration to mini-open surgery to reduce pain and improve functional status in workers     suffering from chronic lateral epicondylosis refractory to 6-month conservative treatment.      This is a prospective single-blind randomized pilot study. Sixty-four subjects will be     randomized into two intervention groups for treatment either by US-guided fenestration or     mini-open surgery. The primary outcome of the study will be the Patient Rated Tennis Elbow     Evaluation (PRTEE) score at 6 month post-procedure.   "
43933|NCT02710617|"     The objective of this study is the evaluation of system accuracy following ISO 15197:2013     (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood     glucose monitoring systems intended for self-monitoring of blood glucose by patients are     stipulated.      However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+     and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use     only on behalf of the IDT with one reagent system lot for each BGMS.      Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)   "
43934|NCT02710604|"     This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of     CMX157 at increasing dose levels.   "
43935|NCT02710591|"     In Duchenne Muscular Dystrophy (DMD) there is an imbalance between the levels of calcium and     sodium in the muscles cells which is thought to be important in the damage which occurs     overtime. Sodium/proton type 1 exchanger (NHE-1) inhibition is an innovative pathway that has     proved to efficiently prevent the accumulation of muscle damage (inflammation and fibrosis)     in animal models of muscular dystrophies and heart failure. Based on prior safety and     efficacy results in animal and humans, NHE-1 inhibition with Rimeporide represents a new     therapeutic approach with no restriction on age and on genetic subtypes which could be     combined to other treatments that restore or augment dystrophin.This study examines the     safety and tolerability and effects on the muscles of rimeporide, in patients aged 6 to 14     years with Duchenne Muscular Dystrophy (DMD).   "
43936|NCT02710578|"     Given the known driving behavior of Driving Under the Influence of Alcohol and some of its     parallel to driving under the influence of cannabis, this supplemental study aims to validate     the sensitivity of the primary and secondary outcome measures employed in a cannabis and     driving study currently in progress.   "
43937|NCT02710565|"     Participants who are scheduled to have an endo bronchial ultrasound (EBUS) trans bronchial     needle aspiration (TBNA) will provide additional samples. These samples will then be sent to     Imperial College London to see whether a cell line can be grown.      If growth is successful then the samples will be returned to our pathology department to see     if grading is possible and then to compare these results with the previous diagnostic     samples.      The cell line samples will not be used for patient diagnosis.   "
43938|NCT02710552|"     The aim of the study is to compare the efficacy and safety of low-dose combination of three     antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in     arterial hypertension   "
43939|NCT02710539|"     Randomized comparison of once-daily fixed combiNation versus free-drug combination of three     antihypertensive agents in arterial hypertension   "
43940|NCT02710526|"     Phase II, open label, randomized, two treatment group study designed to evaluate the steady     state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous     administrations of CAM2038.   "
43941|NCT02710513|"     The purpose of this study is to evaluate the healthy properties of a dietary intervention     based on an innovative pasta enriched with prebiotic fibers (barley beta-glucans).      The hypothesis is that the gut microbiota and metabolome, the nutritional status, the     redox/subclinical inflammation parameters and the markers of cardiovascular risk may improve     in healthy subjects.   "
43942|NCT02710500|"     The proposed clinical trial is a double-blind, randomized controlled study with direct     intramuscular injection of rAAVrh.74.MHCK7.DYSF.DV gene vector to the extensor digitorum     brevis muscle (EDB). Two cohorts of subjects with dysferlin deficiency, each with proven     mutations will undergo gene transfer. A minimum of three subjects will be enrolled into each     cohort.   "
43943|NCT02710487|"     Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory     improvement in motor function reported by around 50% of patients affected by Parkinson's     Disease (PD) after sleep and before taking their first dose of dopaminergic medications. The     aim of this study is to test the hypothesis that objective and/or subjective improvement of     motor function might be due to a carry-over effect of Rapid Eye Movements (REM) sleep at     awakening from this sleep phase.   "
43944|NCT02710474|"     The purpose of this study is to compare neurodevelopment and activity in infants born very     preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family     Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).      The study investigator hypothesizes that FNI will improve: i) neonatal     electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and     physiological), and iii) infant behavior and neurodevelopment at 18 months corrected age     (CA).      The two-part study aims to:        -  Part I - replicate efficacy from an earlier trial by conducting the study at multiple          sites to allow for greater generalizability.             -  SC, approximately 90 infants plus the parents             -  FNI, approximately 90 infants plus the parents             -  Term Controls, approximately 25 infants plus the parents - if enrollment not               reached, enrollment may continue in Part II        -  Part II - examine effectiveness by implementing FNI unit-wide so that every baby          receives the intervention.             -  FNI, approximately 90 infants plus their parents   "
43945|NCT02710461|"     The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols     in the modulation of markers of metabolic syndrome. Most of the previous works about     polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As     a consequence, an important amount of dietary polyphenols, the so-called non-extractable     polyphenols are ignored. In contrast, the effect of both extractable and non-extractable     polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as     present in the food matrix and metabolites derived from microbial fermentation will be     evaluated.   "
43946|NCT02710448|"     The study is to treat metformin dose-escalation diabetic subjects of all stages of renal     failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a     possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients     by stage is considered, 60 patients in total.   "
43947|NCT02710435|"     The purpose of this study is to collect long term data of the Neovasc Reducer System in     subjects with refractory angina pectoris.   "
43948|NCT02710422|"     The use of dehydrated human amnionic membrane allograft improves erectile function recovery     (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic     assisted radical prostatectomy (RARP) compared to a control group with no allograft.   "
43949|NCT02710409|"     Influenza is an acute respiratory disease caused by influenza viruses. There are three types     of the virus including A, B and C. Both type A and type B viruses can cause acute febrile     respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough,     sore throat, nasal congestion and general malaise. The main transmission of influenza is     through those highly contagious aerosol droplets containing influenza virus passed from     infected people to susceptible population. Each year in the fall and winter infection of     influenza is widespread in various age groups, with high incidence rate. Although influenza     is generally a self-limiting disease, but in children, the elderly (especially those above 65     years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases such     as diabetes or other certain diseases) and those with poor immunity function, influenza can     easily lead to serious flu complications such as pneumonia, resulting in severe increase of     morbidity and mortality.      In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced     by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct     in healthy Chinese subjects aged 3 years and older.   "
43950|NCT02710396|"     The primary objectives are to determine if tumor genetics (non-synonymous mutation burden >     200 mutations and mutational smoking signature [transversion high]) can predict durable     clinical benefit (DCB) to pembrolizumab. The secondary objective is to determine if a     combined genetic and immune (PD-L1, immune signature) analysis can predict durable clinic     benefit better than either test alone. The exploratory objectives are to identify and     validate candidate neoantigens in vitro; and explore mechanisms of resistance to     pembrolizumab.   "
43951|NCT02710383|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of a cystic     fibrosis disease from plasma   "
43952|NCT02710370|"     The purpose of this research study is to determine how gastric bypass surgery effects     metabolism in obesity and Type 2 Diabetes. One mechanism that has been investigated in animal     models is change to the biology of the small intestine (Roux limb) and how glucose and other     fuels are metabolized (or how the body digests and uses sugar and other fuels). This study     will evaluate the role of the intestine in the beneficial metabolic effects of gastric bypass     surgery. It specifically will examine whether the intestine increases its metabolism and its     activity, and whether this results in an increase in fuel utilization. Thirty two (32)     subjects will be recruited (18 with and 14 without Type 2 Diabetes). At the time of gastric     bypass surgery, a small piece of intestine that is usually discarded will be collected. At     three time points over the first year after surgery, intestinal samples will be obtained by     endoscopy or insertion of a lighted flexible tube through the mouth. Blood samples will be     taken at all time points, as well. All samples will undergo comprehensive metabolic analyses.     Comparisons will be made between the two groups to understand the metabolic changes over time     and if there are differences between the two groups.   "
43953|NCT02710357|"     The aim of this study is to assess the cost-effectiveness of the mandibular overdenture     retained by a single implant. The study hypothesis is that SIMO is more effective but more     costly than the conventional denture, though this incremental cost is relatively low for the     offered effectiveness in terms of clinical and patient-reported outcomes.   "
43954|NCT02710344|"     The overarching aim of this study is to evaluate whether telehealth leads to better mental     health outcomes and decreased use of acute and crisis-based mental health care services by     randomly assigning 300 people with serious mental illness (SMI) and psychiatric instability     receiving services at 1 of 2 community mental health centers (CMHCs), each of which offers     integrated behavioral and primary health care, to either Health Home Usual Care alone or     telehealth plus Health Home Usual Care for 12 months, with assessments at baseline, 3, 6 and     12 months.   "
43955|NCT02710331|"     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids     on simulated driving and related cognition.   "
43956|NCT02710318|"     Immunization is one of the most effective public health interventions. Yet, nationally     coverage has consistently fallen short of national goals, and has remained for the most part     stagnant. The continued presence of vaccine-preventable diseases poses a threat to public     health. In addition to needed improvement of immunization coverage for the general     pediatric/adolescent population, some children with chronic medical conditions need specific     additional immunizations, yet many fail to receive them.      Immunization reminders for providers in the electronic health record (EHR) are a type of     clinical decision support (CDS) that can reduce missed immunization opportunities. One     limitation of these reminders is that they generally depend only on data local to the EHR,     which can be incomplete due to record scatter, leading to inaccurate alerts. An Immunization     Information System (IIS), also known as an immunization registry, is a population-based     system that collects immunization data primarily for children and adolescents from providers     at a regional or state level.      The investigators seek to couple bidirectional exchange of IIS immunization information and     forecasting tools with patient level medical history from the EHR to deliver accurate,     patient-specific EHR immunization reminders.   "
43957|NCT02710305|"     hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and     considered to be the traditional and the gold standard in the assessment of the patency of     the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study     reported the patients complained of moderate to severe pain during the procedure. It is     reported that some patients undergoing hysterosalpingography was more stressful and anxiety     and effect on pain scores.   "
43958|NCT02710292|"     The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE)     for Investigator-rated successful lens centration in Japanese population.   "
43968|NCT02710162|"     Individuals with th Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment     (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and     aspiration pneumonia. These sequelae necessitate timely identification of at risk individuals     to ensure optimal management of oral intake and pulmonary function. The purpose of this study     is to evaluate the discriminant ability of several non-invasive screening tools at detecting     swallowing impairment in individuals with ALS.   "
43969|NCT02710149|"     The main purpose of this study is to explore the therapeutic effect of CD20-targeted chimeric     antigen receptor T(CAR-T) cells in the treatment of B cell malignancies.   "
43959|NCT02710279|"     Suicide is a major health problem that causes annually a million death worldwild. In the     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an     individual's predisposition and stressful condition. We hypothesized that the sensitivity to     social exclusion may represent a core component of the suicidal vulnerability Recent evidence     also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social     stressors are particulary strong and specific triggers of inflammatory response.      To sum up, patients carrying a suicidal vulnerability are expected to present greater     responses to social rejection in terms of inflammatory activity and psychological pain.      The aim of the study is to evaluate the psychological and inflammatory responses to a social     stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the     moderating effect of childhood abuse, attachment, trait rejection sensitivity and social     isolation.      In the second part of the study, we will also investigate the prospective association between     inflammatory responses induces by laboratory paradigms of social rejection and the occurrence     of social distress, suicidal ideation and psychological pain in response to social exclusion     events in real life (using ecological momentary assessment).   "
43960|NCT02710266|"     Liver resection have been a primary treatment option for lesions found in the liver. With     improvements in surgical technique and perioperative patient management, morbidity and     mortality related to liver resection have been greatly reduced. However, many patients with     hepatocellular carcinoma have underlying liver disease. Severity of underlying liver disease     plays an important role in decision making of resection extent. Therefore, liver failure and     decreased liver function following liver resection still remains to be an critical issue.      Postresection liver failure is generally defined by serum total bilirubin greater than 3mg/dL     and prothrombin time of less than 50% of normal (INR >1.7). Pathophysiology of postresection     liver failure is not yet well known. However, sepsis after liver resection, small-for-size     syndrome (SFSS), and ischemia/reperfusion injury are known to have important roles in     persistant liver injury after resection.      After a liver resection, kupffer cells are drastically decreased and innate immunity of the     patient is also damaged. This process causes the patient to be vulnerable to infection. In     addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered and     liver regeneration is affected.      Complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of     hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute     inflammatory cytokines.      Recent studies have reported on many promising effects of the synthetic protease inhibitor,     such as Gabexate mesilate. These include antioxidant effect, inhibition of acute inflammatory     cytokine reaction, and anticoagulatory property. Based on these effects, synthetic protease     inhibitor have gained attention in the role of hepatocyte protection after liver resection.      Currently, there is a report on the hepatocyte protective effects of Gabexate Mesilate on     ischemia/reperfusion injury caused by the Pringle maneuver. However, with the advances in     surgical technique and equipment, many surgeons now perform liver resection without Pringle     maneuver. Therefore, this study was designed to determine effects of Gabexate Mesilate in the     liver resection performed without Pringle maneuver.   "
43961|NCT02710253|"     The goal of this clinical research study is to learn if using radiation therapy can help to     control the cancer after the disease has gotten worse after receiving immunotherapy.   "
43962|NCT02710240|"     A specific aim is to determine if Indocyanine Green (ICG) administered pre-operatively, then     imaged intraoperatively using our camera will aid in the identification of suspected central     nervous system (CNS) tumors. A secondary aim is to understand if the use of ICG during     surgery correlates to MR imaging findings including elevated Cho/Cr ratio, rCBV, Ktrans and     contrast enhancement.   "
43963|NCT02710227|"     Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep     quality, sleep timing parameters and circadian preference were evaluated using the Pittsburgh     Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite Scale for     Morningness (CSM) respectively   "
43964|NCT02710214|"     Duavee is a hormone receptor modulator that has been approved for the treatment of menopausal     symptoms in menopausal women. The goal of this 8-week randomized, double blind, placebo     controlled pilot study, is to determine whether this medication alleviates menopausal     symptoms in women with MS. The investigators will secondarily determine whether addressing     menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering worsening     inflammation.   "
43992|NCT02709850|"     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated     triglycerides and subjects with familial hypercholesterolemia.   "
43965|NCT02710201|"     Objective: Physical activity confers numerous health benefits, yet few adults meet     recommended physical activity guidelines. The impact of brief messages providing feedback on     physical activity was tested in this study. Methods: Young adults were randomly assigned to     one of three conditions: (1) feedback on how active others were, (2) feedback on how active     others were plus a message of approval or disapproval depending on whether the participant     was more or less active than average, or (3) no feedback (control condition). Participants     used pedometers for eight weekdays and recorded their step counts each evening. The group     receiving feedback on how active others were got information about the average number of     steps taken by group members the previous day. The group that also received approval or     disapproval received feedback about the group average, as well as a sad face if the     participant was below the average or a happy face if the participant was above the average.     The control group received no feedback throughout the study. Impacts of these feedback     messages were compared on number of steps taken during the study.   "
43966|NCT02710188|"     The purpose of this study is to find a modified release oral tablet formulation for this     drug, which will be safe and well tolerated.   "
43967|NCT02710175|"     Infertility is defined as the inability of a couple to achieve pregnancy over an average     period of one year (in women under 35 years of age) or 6 months (in women above 35 years of     age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or     both. It can be either primary or secondary.      Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy     as well as fertility, regardless of the presence of disease in women of reproductive age. In     particular, hypothyroid women are at an increased risk of menstrual disorders and infertility     because of altered peripheral estrogen metabolism, hyperprolactinaemia and abnormal release     of gonadotropin-releasing hormone.      The prevalence of subclinical hypothyroidism characterized by aberrant high serum     thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile     women are reported to be approximately 20% and it is a primary cause of subfertility.      Indeed, average TSH levels in infertile women were reportedly higher than those in normal     fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve     in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical     hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve     fertility to successful pregnancy.      This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers et     al., 2013).      On the other hand, female fecundity decreases with increasing age, primarily because of     decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging     to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and     differentiation. It is produced by the granulosa cells from pre-antral and small antral     follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely     correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker of     ovarian age in women of reproductive age.      Expectedly, ovarian function may be affected by impaired thyroid function, although this     association has not been elucidated. In this study, we will evaluate the relationship between     thyroid function and AMH levels by comparing them in infertile patients and healthy fertile     women.   "
43971|NCT02710123|"     Adolescents with concussion will be randomly assigned to a treatment group where they will     receive sub-threshold exercise, or assigned to a placebo group where they will receive     structured stretching exercises. Both groups will receive standard medical coverage with     regular clinic visits. All participants will record symptoms daily on a dedicated web site.     All participants will be evaluated at time 1 with (1) structured physical exam, and (2)     structured exercise stress test which is terminated when there is symptom exacerbation. The     primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for     two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of     symptoms, and (3) confirmed by a physician based on a structured physical exam.   "
43972|NCT02710110|"     Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are     hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of     fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4%     of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions are     currently lacking. Although the use of exercise in ALS is controversial, recent evidence     suggests that mild to moderate intensity exercise applied early in the disease slows disease     progression, improves motor function, preserves motor neuron number, reduces muscle     hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human     clinical trials.      This research study is designed to determine the impact of respiratory strength training on     breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis     (ALS).   "
43973|NCT02710097|"     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids     on simulated driving and related cognition.   "
43974|NCT02710084|"     This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin     as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a randomized,     placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12     weeks (phase 2). The purpose is to evaluate the effect of intranasal oxytocin on impairments     in attention, social memory, socialization, language, and repetitive behaviors.   "
43975|NCT02710071|"     Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.     They often develop high blood pressure. We are not sure what drug is best to treat the high     blood pressure. This study will give the patients nebivolol or hydrochlorothiazide (HCTZ) for     6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24 hour     monitoring.   "
43976|NCT02710058|"     The investigators are conducting a study entitled 'Experience of Arab American Women with     Breast Cancer: In-depth Interviews' through which they hope to learn more about Arab women's     experience with breast cancer.   "
43977|NCT02710045|"     The purpose of this study is to investigate for the broad immunological effects of     administering measles vaccine (MV) and diphtheria-tetanus-whole cell pertussis vaccine (DTP)     to 9 month old Gambian infants, either alone or together. Effects on vaccine-specific immune     responses, innate immunity, and immune memory were studied. The hypothesis is that when MV     and DTP are given together there will be more inflammation and this will interfere with     generation of immunity to the vaccine and to other non-vaccine related stimuli.   "
43993|NCT02709837|"     This project aims at assessing        -  the impact of heat treatment on the bioavailability of meat carnosine and amino acids,        -  the interaction between masticatory efficiency and heat treatment of meat on the          bioavailability of carnosine and amino acids        -  the effect of dietary calcium on tomato lycopene bioavailability.   "
44045|NCT02709161|"     The purpose of this study is to determine the clinical efficacy of augmenting     cognitive-behavioral therapy with real-time functional magnetic resonance imaging     neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive     autobiographical memories.   "
43978|NCT02710032|"     The investigators propose a social network-based PrEP adherence intervention as part of a     comprehensive, context-specific approach to HIV prevention for TW in Lima, Peru. In order to     be effective, PrEP-based prevention strategies need to address not only biological efficacy,     but also individual behavioral decision-making processes, interpersonal partnership contexts     of risk, peer norms of sexual behavior and PrEP adherence, and structural access to     prevention technologies. Using a health promotion behavioral model that combines Social     Action Theory with social network theories of information dissemination and collective     behavior change, the investigators propose to develop and refine a network-based intervention     that promotes PrEP adherence in the existing social networks of TW. Formative research will     outline individual, partner-level, and network-based contexts of sexual risk behavior,     patterns of social network interactions, anticipated adoption and use of new prevention     technologies, and optimal content for a PrEP adherence intervention. Findings will be used to     define the elements of a prevention intervention using social networks of TW and social media     technologies to generate, implement, and reinforce social norms of PrEP adherence and risk     behavior reduction for TW.   "
43979|NCT02710019|"     The purpose of this study is to determine whether the Back to Reality series video games -     Harry's Journey, Harry's Journal, and Pathways to care map - are effective at educating     homeless and street involved youth, registered at the Youth Services Good Shepherd Hamilton,     about the emotional, social, and psychiatric sequel of problematic underage substance use.     The objectives of the video games are to promote early detection and awareness of mental     health and substance use problems among youth.   "
43980|NCT02710006|"     The purpose of this trial is to evaluate the feasibility and reliability of automatic volume     calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and     uterine cavity will be acquired during three-dimensional ultrasonography and     sonohysterography. After that independent observers will measure offline the uterine cavity     volume using automatic volume calculation using SonoAVC general software, and VOCAL software.   "
43981|NCT02709993|"     The purpose of this study is to determine the safety and efficacy of Tumor Associated Peptide     Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of hematologic     malignancies.   "
43982|NCT02709980|"     The current study seeks to evaluate cognitive behavior therapy for insomnia (CBT-I), a     non-medication treatment, in recent TBI patients compared to a sleep education control     intervention. Patients will participate in CBT-I treatment (or sleep education treatment)     weekly for six weeks, and will have a 3-months follow-up visit in order to examine the     efficacy and time course of treatment. In addition, participants will complete several     self-report questionnaires in order to examine sleep and neuropsychiatric symptoms throughout     treatment.   "
44018|NCT02709512|"     This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme     versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate     synthetase 1 expression. Malignant pleural mesothelioma have been found to require arginine,     an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the     malignant pleural mesothelioma cells will starve and die.   "
43983|NCT02709967|"     Background Adolescent pregnancies carry risks to the young mothers and the baby. Keeping     girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young     rural girls have given birth by the age of 18 years, and the pregnancy rates are particularly     high among girls who are out-of-school. Approximately 50% of girls never enroll in secondary     school. Widespread myths and negative social norms are barriers to adolescent girls using     modern contraceptives, thus contributing to high rates of early pregnancy. However, there is     little robust research from Africa on how sexual and reproductive health programmes can be     delivered in a way that actually affects early marriage and pregnancy rates.      Purpose To measure the effect on early childbearing rates in a rural Zambian context of (1)     economic support to girls and their families, and (2) combining economic support with a     community intervention to enhance knowledge about sexual and reproductive health and     supportive community norms      Design Cluster randomized controlled trial with three arms with clusters being rural basic     schools (With grades 1-9) with surrounding communities.      Study population The participant population will be girls enrolled in grade 7 in January in     2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka,     Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano.      Study size Approximately 5000 girls and 157 clusters, that is 1000 girls and 31 clusters in     the control arm and 2000 girls and 63 clusters in each of the intervention arms. The     rationale for having different numbers of clusters is that we expect larger differences     between each of the intervention arms and the control arm than between the two intervention     arms themselves.      Intervention One intervention arm will be offered economic support in the form of monthly     cash transfers to the participating girl and her parents and payment of school fees in 2017     and 2018 if the girl attends junior secondary school. The second intervention arm will be     offered the same economic support combined with a community component comprising community     meetings about the value of education for adolescent girls and the risks related to early     childbearing, and a youth club for girls and boys (both in- and out-of-school).   "
43984|NCT02709954|"     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids     on simulated driving and related cognition.   "
43985|NCT02709941|"     The purpose of the current study is to investigate the effects of a novel breathing training,     called inspiratory muscle strength training (IMST), on sleep patterns, breathing and blood     pressure for patients diagnosed with mild, moderate and severe sleep apnea.   "
43986|NCT02709928|"     Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of TD-0714 in healthy adult and elderly subjects   "
43987|NCT02709915|"     This study is undertaken to explore in patients with uncontrolled T2D treated with insulin,     whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG     expression and will be more effective for weight loss and for achieving glycemic control and     reduction of total daily insulin dose compared to an isocaloric diet with 6 small meals     distributed evenly along the day   "
43988|NCT02709902|"     Bioequivalence with Clinical Endpoints.   "
43989|NCT02709889|"     To assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific     delta-like protein 3-expressing advanced solid tumors.   "
43990|NCT02709876|"     A single arm, single center trial to evaluate the safety and efficacy of autologous purified     populations of bone-marrow derived stem cells in patients with Retinitis Pigmentosa (BM-SCs)     through a 48 month follow up period.   "
43991|NCT02709863|"     This study will compare the effects of sevoflurane, desflurane and total intravenous     anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal     transsphenoidal surgery of pituitary gland. Participants will be divided into three equal     groups. The first group will receive sevoflurane, second grup will receive desflurane and     third grup will receive total intravenous anaesthesia. Investigators are also going to     evaluate blood gas analysis.   "
43994|NCT02709824|"     Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.      A prospective, cross-over, randomized clinical trial will be carried out in triple blind to     compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without     anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the     study includes two sequential stages: in the first phase, the immediate objective and     subjective evaluation of dental discoloration by spectroscopic and questionnaire-based     analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A     wash-out period between the cycles of 21 days will be performed.      In the second phase, a long-term (after 6 months) subjective evaluation of dental     discoloration will be obtained by means of clinical photograph visual analysis and new     questionnaires.   "
43995|NCT02709811|"     Electrochemotherapy (ECT) is a non-thermal tumour ablation modality. It consists of the local     potentiation, by means of local reversible electroporation of tumour tissues, of the     antitumor activity of non-permeant or poorly permeant anticancer drugs already possessing     intrinsic cytotoxicity. ECT has proved to be effective in the treatment of various cutaneous     tumour nodules of any origin. Mostly ECT is offered to patients in case of multiple cutaneous     metastases, when they cannot be excised, due to their number or localization. This study     investigate the application of ECT in the treatment of liver metastases from colorectal     adenocarcinoma, for which other thermal cytoreductive methods would be risky compared to the     supposed expected clinical benefits.   "
43996|NCT02709798|"     The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could     reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac     magnetic resonance imaging) in patients with STEMI after primary PCI   "
43997|NCT02709785|"     The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced     Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse     and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical     to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium     chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque     and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste     perception, malodor and calculus.   "
43998|NCT02709772|"     10 Clinics within Stanford Health Care are randomized to receive or not receive provider     alerts for 5 commonly overused tests and treatments.   "
43999|NCT02709759|"     The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized     controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care     clinics (one in the Northeast and one in the South). The first study factor will compare     brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized     normative and HIV-specific feedback. The second factor compares an interactive text messaging     (ITM) intervention vs. no text messaging. The final factor compares intervention of low     intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5     sessions over 9 months.   "
44000|NCT02709746|"     Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive     symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical     Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).   "
44001|NCT02709733|"     The loss of motivation has emerged as a critical symptom in schizophrenia that is     consistently linked to functional disability for affected individuals. Despite advances in     treatment, there have not emerged any effective treatments for this loss of motivation, which     ultimately hinders our ability to promote recovery for individuals with schizophrenia. To     address this critical unmet therapeutic need, this study aims to investigate a novel     computerized motivation rehabilitation program using virtual reality to treat motivation loss     in schizophrenia.   "
44002|NCT02709720|"     Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as     induction therapy and subsequent concomitantly with radiotherapy (RT) in patients with lung     cancer (NSCLC) locally advanced unresectable   "
44003|NCT02709707|"     Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users   "
44004|NCT02709694|"     In patients with Crohn's Disease, symptoms of inflammatory back pain (IBP) precede changes on     plain X-rays by years, and MRI changes of axial inflammation precede development of X-ray     changes. Sacroiliitis on MRI without x-ray changes (i.e.Non radiographic SpA) is a valid     diagnostic criterion for Spondyloarthritis (SpA) and leads to earlier diagnosis of SpA in     patients with IBP. It is unclear when MRI changes occur, and if they precede clinical     symptoms of IBP. There are reports of asymptomatic sacroiliitis noted on MRI in Crohn's     patients. This is important, as MRI evidence of inflammation may be the first sign of     incipient SpA. Inflammation in other regions of the axial skeleton in SpA patients has also     been documented, but its significance is unknown. The prospect of undiagnosed and untreated     inflammation is concerning, as it can lead to significant morbidity. Moreover, relationship     between MRI evidence of axial inflammation-likely a proxy for systemic inflammation- and     patient reported outcomes (e.g. ASDAS-CRP= Ankylosing Spondylitis Disease Activity Score- C     reactive protein, BASDAI= Bath Ankylosing Spondylitis Disease Activity Index, SF-12 = Short     Form- 12, HBI= Hervey Bradshaw Index and PROMIS-29= Patient Reported Outcome Measurement     Information System-29), has not been reported. Recent unpublished data from Dr. Longman's lab     (collaborator) suggest a distinct intestinal dysbiosis in Crohn's associated SpA. But     relationship between this microbiome and MRI changes is yet to be determined.      Identifying inflammation earlier on MRI- in the absence of clinical symptoms will provide an     opportunity to intervene early with available therapies, such as- biologics etc. Asymptomatic     MRI changes could be a marker of underlying systemic inflammation- which is a risk factor for     poor outcomes in Crohn's associated SpA. Studying association between whole spine MRI changes     with patient reported outcomes) may facilitate informed clinical decision making to initiate     targeted therapy to prevent progression of structural damage. Understanding microbial     dysregulation in this population, and correlation with MRI changes, could lead to development     of therapy targeted to restore intestinal symbiosis.   "
44005|NCT02709681|"     This is a retrospective cohort study of Sickle Cell Disease (SCD) patients attending 32     treatment centers across Italy. The aim of this study will be to report the Italian     experience with the use of hydroxyurea in a large cohort of SCD patients and to evaluate the     benefits and safety of this intervention for the prevention and management of a wide range of     clinical morbidities   "
44006|NCT02709668|"     A randomized double-blind placebo controlled study of reduced B vitamins in patients with     major depression who were positive for one or both of the common MTHFR polymorphisms was     conducted between 8/1/2014 and 4/3/2015. Homocysteine levels and MADRS scores were used as     primary measures. The study was designed to test safety and efficacy of reduced B vitamins in     MDD associated with MTHFR. This study examines the data from the trial to see effects, effect     sizes, and further, if demographic factors and other patient characteristics correlated with     findings.   "
44008|NCT02709642|"     The purpose of this study is to determine if a financial deposit contract is a successful     method of helping people to maintain their weight loss. A deposit contract is an agreement in     which participants put their own money at risk, with the goal of earning it back by     achieving a goal, in this case maintaining prior weight loss. The study will also evaluate     the interventions using survey research to assess the feasibility and acceptability of the     interventions.   "
44009|NCT02709629|"     The current study examines the efficiency of a home-based computerized cognitive training     (CT) intervention targeting older adults with diabetes.The primary aim of the study is to     evaluate the effects of CCT on cognitive and disease management in non-demented older     diabetes adults. Investigators will also evaluate the effect of the intervention on a range     of secondary outcomes, including mood, caregiver burden, self-efficacy, and for a small     sub-sample, on brain activity as reflected in changes in task-related blood-flow on fMRI.   "
44010|NCT02709616|"     Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is     designed to perform a personalized clinical trial by first analyzing the expression of tumor     associated antigens in patients with newly diagnosed glioblastoma and then immunizing the     patients with personalized DC-based cellular vaccine. In addition, allogeneic peripheral     blood mononuclear cells (PBMCs) will be used as cellular vehicle for immunization. Safety and     efficacy will be observed in the study.   "
44011|NCT02709603|"     Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to     relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an     antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to     relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor     gynecological procedures. So the efficacy of hyoscine use are still controversial and no     previous studies investigated its efficacy for pain relief in HSG procedure.   "
44012|NCT02709590|"     The aim of our study is to determine the efficacy of oral diclofenac potassium combined with     lidocaine cream on the pain scores during HSG.   "
44013|NCT02709577|"     The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier     Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.   "
44019|NCT02709499|"     Cardiovascular diseases are the leading causes of morbidity and mortality in Brazil and     surgical procedures to treat these disorders have grown dramatically in recent years. Since     the first heart surgery in successful open field in humans, conducted in 1953 by John Lewis,     many techniques have been used to improve the outcome of surgery and reduce their side     effects. The low-level laser therapy (LBP) has been widely used in clinical practice for pain     relief purposes, reducing inflammation and stimulating tissue healing. However, the effect of     this therapy has been little elucidated in patients with cardiac disease. The objective of     this study is to evaluate the effect of low level laser therapy on the inflammatory profile     and cardiac tissue healing markers of patients in the postoperative period of CABG surgery.   "
44020|NCT02709486|"     Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth     factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important     breakthrough in the treatment of chronic pain and is under clinical investigation for the     treatment of pain associated with osteoarthritis or other chronic pain conditions.      The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and     2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects     with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy     benefits with a favorable safety profile when administered intravenously in previous Phase 3     clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg     dose based on data from previous studies.   "
44021|NCT02709473|"     Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway     in patients especially at risk of aspiration. Propofol and rocuronium are generally used     agents for RSI. However, the difficult airway scenarios are always valid for these patients,     even without predictive signs of difficult airway. Therefore, it is important to decrease the     rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with     the aid of a reversal agent in case of difficult airway. The short acting opioids such as     remifentanil may be helpful to reduce the dose of rocuronium in RSI.   "
44022|NCT02709460|"     Laparoscopic hysterectomy is associated with complications in form of infections and     subsequently dehiscence of the vault. This is a serious complication. The infection may be     related to the frequently observed postoperative hematoma following traditional laparoscopic     hysterectomy where the uterine artery is coagulated and divided at the cervical entry into     the uterus.      By coagulation of the uterine artery laterally close to the internal iliac artery this     problem may be eliminated due to the much less bleeding observed during this procedure.   "
44023|NCT02709447|"     Girls in the juvenile justice system are at high risk for dating violence exposure as well as     co-occurring problems with delinquency and sexual risk taking. Despite the multitude of     negative outcomes associated with dating violence, no evidence-based preventive interventions     exist for juvenile justice girls. This study will advance scientific knowledge by testing the     efficacy of a promising, skills-based intervention (Date SMART) on reducing dating violence,     delinquency and sexual risk outcomes for a broad range of court-involved, non-incarcerated     girls.   "
44024|NCT02709434|"     Fatigue is a very frequently reported symptom in patients with inflammatory bowel disease     (IBD), whether it is Crohn's disease (CD) or ulcerative colitis (UC). Sometimes the fatigue     may be easily explained by other symptoms or tests which show that the disease is active. For     example patients may be anaemic (have a low blood count) which can in itself lead to a     feeling of being tired all the time. Treatment of the disease can make some of these patients     feel less fatigued.      However, 4 or 5 out of every 10 patients with IBD which is felt to be in remission (ie not     active disease) report fatigue. This can have far-reaching implications for patients in their     everyday lives, with issues around work or school, close relationships, travel and leisure     being profoundly affected. The CCUK funded research on fatigue and IBD, led by Professor     Christine Norton and Wladzia Czuber-Dochan at King's College London, has identified fatigue     as being a significant issue facing patients and has also highlighted that few doctors offer     help and support beyond treating the disease itself when active. This is partly because     fatigue itself has been difficult to measure and so any study designed to treat fatigue would     be limited by being unable to quantify any improvement in a meaningful way.      Fortunately the King's College group have developed a 'fatigue score' which is a simple     questionnaire that is able to quantify the severity of fatigue. The aim of our study is to     assess the effect of a structured support and educational programme on the levels of fatigue     in patients with inactive IBD who report moderate or severe levels of fatigue. A secondary     component of our study is to see if there are any associations between fatigue levels and     disease activity or other parameters such as quality of life, anxiety or symptoms of     overlapping irritable bowel syndrome.      Patients will be approached in the out-patient or telephone clinics and the study will be     explained with written information and any questions will be answered. If they agree to being     involved they will be asked to complete the fatigue and a number of other questionnaires in     addition to having the standard assessment of symptoms, blood tests and a stool specimen.     Patients with active disease will be excluded from the subsequent group interventions but the     data they have provided to this point will still be helpful in our understanding of fatigue     in IBD. Patients identified as being in remission following the initial assessments will be     offered the opportunity to be involved in the next stage of the study. The stool samples will     also be analysed for the microbiome ie which bacteria are present as some studies suggest     that patients with IBD may have a reduced diversity of bacteria in their intestines.      Half of this group will be randomised to active intervention and half will act as a control     group for the rest of the study. The active intervention will involve completion of activity     diaries over the following two weeks and then analysis of the diaries and agreement on     behaviour changes designed to help fatigue. This will be supported by written information and     three, monthly small group sessions to reinforce and support these changes.      At the end of the study all patients will again complete the fatigue and quality of life     questionnaires and have their disease activity assessed by symptom scores, blood and stool     tests. The baseline results and the final results will be analysed to see if there is any     improvement in fatigue in the group undergoing the programme of support and behaviour change.      This is only a small pilot study but if it demonstrates that the intervention is feasible and     may help with fatigue then a larger study will be performed to try and confirm our initial     findings.      Our ultimate aim is to find a simple intervention to empower patients to deal with the     difficult task of living with IBD and the fatigue that this can bring.   "
44025|NCT02709421|"     Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most     frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been     proved to be effective in reducing the incidence of PEP. It has been widely used to prevent     PEP in patients, especially those with potentially high risks of PEP. However, rectal     indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients     receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients     receiving rectal indomethacin remains unclear. The aim of the study was to identify potential     risk factors in high-risk patients whose received administration of prophylactic rectal     indomethacin after ERCP.   "
44046|NCT02709148|"     The purpose of this study is to use an investigational device to record brain activity for     12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The     goal of the study is better understanding of brain activity in Parkinson's disease and how     they relate to DBS and pharmacological management, not to bring new devices to market.   "
44026|NCT02709408|"     Among antibiotic-resistant organisms, the Gram-negative bacteria are now the most important     challenge because of the rapid worldwide spread of mechanisms conferring resistance to     multiple drugs. The most recent and worrying problem is the emergence and spread of     carbapenemases. Additionally, carbapenem-resistance is known to be very frequent among     Acinetobacter baumannii isolates for many years. Overall, the therapeutic options available     against carbapenem-resistant Enterobacteriaceae (CRE) and A. baumannii (CRAB) are very     limited. The best available treatment (BAT) against CRE is unknown, which is a challenge for     therapeutic decisions and also for the design of randomized trials with new drugs. The     generic objectives of EURECA are to obtain high‐quality observational data to inform the     design of randomized controlled trials for complicated intraabdominal infections, pneumonia,     complicated urinary tract infections and bloodstream infections due to Carbapenem-resistant     Enterobacteriaceae (CRE) and carbapenem-resistant Acinetobater baumannii, and to provide     cohort data that could eventually be used as historical controls for future comparisons with     new drugs targeting CRE. This will be achieved by a prospective, multinational cohort study     of patients with targeted infections due to CRE and CRAB, and by matched case-control-control     studies.   "
44027|NCT02709395|"     This study is designed as an open, prospective, single arm, multicenter study in order to     investigate patient satisfaction, perception and compliance for the novel Navina Smart, a     transanal irrigation (TAI) system. Approximately 30 male and female subjects who are     currently practicing TAI, will be followed during a 4-week period of use of Navina Smart.     Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and     TAI frequency will be collected via patient reported outcome (PRO) questionnaires.   "
44028|NCT02709382|"     This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and     female subjects with normal and impaired renal function. The study will be composed of five     groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal     impairment, end stage renal disease patients on hemodialysis (6 patients) and their     respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).   "
44051|NCT02709083|"     This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in     treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in     which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature     blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth     of cancer cells by blocking some of the enzymes needed for cell growth.   "
44029|NCT02709369|"     The purpose of this study is to explore the functional and physiological effects associated     with the use of High-resolution, relational, resonance-based, electroencephalic mirroring     (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and     neuropsychological disorders. This is a non-randomized, open label, and unblinded     before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common     denominator (heart rate variability, HRV), across a variety of relevant conditions, as well     as changes in clinical symptoms inventories, to generate hypotheses and pilot data for     investigation in future proposals.   "
44030|NCT02709356|"     Evaluate and compare the changes in brain ketone and glucose uptake after taking two     different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with     Alzheimer's disease and a control group.   "
44031|NCT02709343|"     This study is designed for lung transplant patients who have developed chronic lung allograft     dysfunction (CLAD). Consented patients will receive 4 intravenous doses of allogeneic,     bone-marrow-derived MSCs (2*10^6 cells/kg/dose) or matching placebo over a period of 2 weeks     with a 12 month follow up.   "
44032|NCT02709330|"     This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial     utilizing a historical control group. Participants will receive a Lunasin regimen and will be     asked to register for an account of PatientsLikeMe website, where after the initial in-clinic     visit, they will be asked to enter specific data.   "
44033|NCT02709317|"     Veterans who are taking prescription opioids for chronic pain and are engaging in risky     drinking are at heightened risk for drug interactions, including overdose and other negative     effects, particularly if they are also using benzodiazepines. In this application, the     investigators propose to test an integrated prevention intervention, designed to reduce rates     of risky drinking in veterans receiving prescription opioids to treat their chronic pain.     This adaptive, patient-centered intervention provides integrated clinical assessment, brief     intervention, monitoring, and extended prevention services delivered through a combination of     clinical visits, telephone calls, and text messages. The investigators propose to conduct a     study in which veterans (N=300) who are on daily doses of prescription opioids and screen     positive for risky alcohol use will be randomized to receive 12 months of an adaptive     integrated prevention intervention (IPI) or to standard care (SC), which consists of a Brief     Intervention (BI) with 2 follow-up contacts. Potential participants will be veterans at the     Philadelphia VA, and surrounding areas, or the Pittsburgh VA who, based on pharmacy records,     are using opioids daily to treat chronic pain. An initial evaluation will identify     individuals who also engage in risky alcohol use based on NIAAA-recommended guidelines and     meet other inclusion criteria to be enrolled in the study. The evaluation will also identify     the use of other medications (e.g., benzodiazepines) that could interact negatively with     opioid use. For veterans randomized to the IPI condition, a BI is first provided to reduce     alcohol to non-hazardous levels and the effects are monitored for one month. Veterans who     reduce alcohol use to non-hazardous levels during this one-month period continue in a     monitoring track, consisting of tailored text messages and brief monthly telephone contacts.     Veterans who continue to drink at risky levels are instead placed in a track that provides     tailored text messages and more frequent telephone calls. In addition to monitoring, these     calls provide further prevention/BI services to help the veteran reduce alcohol use to     non-hazardous levels. Key components of these services are motivational enhancement and     development of more effective ways to cope with stress and other triggers for risky alcohol     use. All participants will be followed up at 3, 6, 9, 12 and 18 months after baseline. The     primary outcome at each follow-up point will be a dichotomous measure of any risky drinking     since the prior follow-up (yes/no). Secondary outcomes will include self-reported frequency     of heavy drinking, biological measures of alcohol use, other drug use as determined by urine     toxicology tests, opioid overdoses, and ratings of depression and pain. Repeated measures     analyses will compare the IPI and SC conditions on primary and secondary outcomes assessed     across an 18-month follow-up. Analyses will also test hypothesized moderation and mediation     effects.   "
44034|NCT02709304|"     This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease     pain and discomfort associate with Foley catheters upon awakening from general anesthesia in     the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial     colony counts from urine obtained from the surgical patients after insertion of the Foley     catheter prior to prophylactic antimicrobial administration.   "
44071|NCT02708823|"     A common complication after surgery is a temporary state of confusion called postoperative     delirium (PD) affecting particularly elder patients. In 2014, a computer program for tablet     computers named Delirium Risk Profile (DRP) was developed at the University Hospital Basel to     assist preoperative screening. The aim of this study is to generate normative data with     cognitively healthy participants for the DRP.   "
44072|NCT02708810|"     To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a     single institution prior to multi-institutional enrollment.   "
44035|NCT02709291|"     Early childhood disruptive behavior problems lead to significant costs to families and     society, but can be reduced with behavioral parent training interventions. To increase the     public health impact of these interventions, their feasibility, accessibility, and     acceptability in high-need, underserved communities must be ensured. This pilot project will     systematically adapt and pilot-test the delivery model of an existing effective parent     training intervention for implementation in rural Appalachia, a region with many documented     health disparities, high levels of poverty, and shortages of mental health providers.     Community health workers in 5 rural Appalachian counties will be trained to deliver a     behavioral parent training intervention. Each worker will deliver the intervention to 4     parent-child dyads.   "
44036|NCT02709278|"     TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge     administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will     also look to evaluate and compare the amount of BCG recovered from the lungs and from the     skin, following challenge by either the aerosol or the intradermal route.   "
44037|NCT02709265|"     This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing     healthy volunteers following a single dose of amikacin/fosfomycin, using the PARI     Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer. Three doses (30/12     mg, 60/24 mg, 90/36 mg amikacin/fosfomycin) will be evaluated. Following this evaluation, a     single dose and nebulizer will be chosen to further evaluate systemic, bronchoalveolar, and     urine pharmacokinetics in spontaneously breathing healthy volunteers.   "
44038|NCT02709252|"     Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one     of the best parameter to predict fluid responsiveness in patients under general anaesthesia.     Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the     pneumoperitoneum has been recently seen suggested as a limitation to their interpretation.     The aim of this observational study is to compare changes in ΔPP and PVI related to     autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in     patients undergoing elective surgery.   "
44039|NCT02709239|"     The purpose of this study is to learn how much DHA to give to mothers in order to provide     enough to the baby. Researchers will also learn if there are differences in development of     the baby up to 12 months after birth.   "
44052|NCT02709070|"     There is little evidence showed that adjuvant therapy had been shown to extend the survival     of patients with hepatocellular carcinoma (HCC) receiving surgical resection. We investigated     whether injections of highly-purified Cytotoxic T lymphocytes prolongs recurrence-free     survival of patients after resection for HCC.   "
44053|NCT02709057|"     The aim of the study is to compare the effect of lifestyle intervention (diet and physical     activity) by applying modern approaches to lifestyle changes on the prevention of incident     T2DM and the worsening of hyperglycemia in people with high number of T2DM risk alleles and     in people with low number of T2DM risk alleles compared to corresponding control groups.   "
44040|NCT02709226|"     Background:      A glioblastoma is a tumor in the brain. It is treated with surgery, chemotherapy and     radiation therapy. However, most people s tumors come back after therapy. When the tumor     grows back, surgery or chemotherapy may not be possible or may no longer work. Repeat     radiation therapy or re-irradiation, is an option for treating these tumors when they regrow.      Objective:      To find out the safety and highest tolerated dose of re-irradiation for people who have     recurrent glioblastoma.      Eligibility:      People ages 18 50 who have glioblastoma that has been treated with radiation but has regrown.      Design:      Participants will be screened with:      Medical history      Physical exam      MRI of the brain: They will lie in a machine that takes pictures of the brain.      Participants will have baseline tests before they start therapy. These will include:      Blood tests      Neuropsychological tests: These test things like memory, attention, and thinking.      Quality of life questionnaire      Eye and hearing tests      Participants will get a CT of the brain prior to radiation start in order to plan the     radiation treatment. Once the plan is completed, they will receive radiation once a day     Monday Friday for a total of 10 17 treatments. They will lie on their back for about 10     minutes while they get the treatment.      Participants will be monitored for side effects.      After they finish treatment, participants will have visits 1, 2, and 3 months later. Then     they will have them every 2 months for 3 years. These will include:      Medical history      Physical exam      Blood tests      MRI of the brain.      Quality of life questionnaire      Neuropsychological tests (at some visits)      After 3 years, participants will be contacted by phone each month.   "
44041|NCT02709213|"     The aetiologies of computed tomography-diagnosed acute colitis remain surprisingly unknown.     Moreover, no diagnostic tool or clinical score allow to quickly determine or at least     stratify the exact cause of colitis in patients admitted at an Emergency Ward and to direct     them to the appropriate therapeutic care. The aims of the present study are to describe the     presentation and aetiologies of acute colitis, and to develop diagnostic methods to guide     patients admitted for acute colitis to the appropriate therapeutic care, particularly     colonoscopy.   "
44042|NCT02709200|"     This is a prospective study looking at the effects of dexmedetomidine on pacemaker function     in patients who have surgery for congenital heart disease utilizing cardiopulmonary bypass     (CBP). For the purpose of the study, no change in intraoperative care will be dictated. The     use of dexmedetomidine will be left up to the discretion of the treating physicians. The     study will involve only the collection of data regarding the amplitude required to capture     and specific demographics and intraoperative features including cross clamp time, time on     CPB, and vasoactive agents that were and are being administered. In addition to these data,     it will be noted whether dexmedetomdine was used or not and whether it is being administered     on arrival to the CTICU.   "
44043|NCT02709187|"     An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the     pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a     fixed dose combination compared with coadministration of separate constituents in healthy     adult volunteers   "
44044|NCT02709174|"     Objective: To evaluate whether trimester specific d-dimer levels and brain natriuretic     protein (BNP), along with the modified Wells score (MWS), is a useful risk stratification     tool to exclude pregnant women at low-risk of pulmonary embolism (PE) from diagnostic imaging     with radiation exposure.   "
44047|NCT02709135|"     Approximately 8-10 million patients complaining of chest pain present to an Emergency     Department (ED) annually in the United States. These patients are a challenge to healthcare     providers, who are tasked with determining whether these symptoms are due to an acute     coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of     care for patients with acute chest pain, our group recently validated a risk stratification     pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on     higher-risk patients, who are more likely to benefit from testing.While the HEART score has     been well validated in the ED setting, it has yet to be implemented in a prehospital setting.     Paramedics are often the first providers to evaluate and begin treating patients with     symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a     combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI     (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often     have difficulty distinguishing high-risk patients from low-risk patients.Thus,     multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine     have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT®     point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the     feasibility and accuracy of HEART score and POC testing in the prehospital setting the     investigators propose a quality surveillance study of a limited implementation of the HEART     score with POC troponin testing.   "
44048|NCT02709122|"     The study aims to determine the level of knowledge and skills to recognize and decompression     of tension pneumothorax   "
44049|NCT02709109|"     The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in     saline compared to saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of     age, homozygous for the F508del-CFTR mutation, and being treated with Orkambi   "
44050|NCT02709096|"     This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate     the comparative reduction of Propionibacterium acnes in-vivo following once daily topical     administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.   "
44054|NCT02709044|"     The aim of this study is to establish the influence of early administration of a bolus of     intravascular fluid in patients with a diagnosis of acute pancreatitis on the course and     outcome of disease.   "
44055|NCT02709031|"     Cicletanine, which has been approved and launched for hypertension in France and Germany, has     promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in     vitro, animal and human studies that cicletanine's optimal dose in diabetes and other     challenging, critically-unmet needs is likely to be higher than that for hypertension.     Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects are     documented to be potassium loss and sodium loss from thiazide-type activity (one of the     therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be     reversed safely by magnesium. This trial explores the ability of magnesium to enhance     cicletanine safety at higher doses in a trial involving patients with hypertension     complicated by diabetes.   "
44056|NCT02709018|"     This study is being conducted to determine if losartan, an angiotensin receptor blocker     (ARB), is safe and effective in the treatment of posttraumatic stress disorder (PTSD)     symptoms. The study is also intended to determine if certain genetic markers are useful in     predicting PTSD symptom reduction with losartan. Approximately 160 subjects with chronic PTSD     ages 18-65 will participate in this study across five sites. Subjects will be assigned by     chance to take either flexibly dosed losartan (up to a maximum dosage of 100 mg) or placebo     (which resembles the study drug but has no active ingredients), once a day for 10 weeks.     Furthermore, it is hypothesized that CC homozygotes for rs4311 SNP in the ACE gene will have     a superior response to losartan on PTSD symptoms compared to T carriers.   "
44057|NCT02709005|"     This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial     enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to     receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary     objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to     vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5%     Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.   "
44058|NCT02708992|"     This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q     8-hour schedule) alone and also co administered with a single 1000 mg oral dose of     azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels     of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and     whether there are significant changes in cefixime PK after co-administration. The primary     pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg     doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds     2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg     doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin,     achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to     evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen     of 800   "
44059|NCT02708979|"     The high worldwide prevalence of overweight and obesity as well as metabolic and disease     consequences, are well-documented. The positive energy balance underlying obesity is     attributable to excess energy intake and/or insufficient energy expenditure. However, it     seems that the increase in mean body weight can be sufficiently explained by increases in     mean energy intake. It has been proposed that this overeating is partly caused by increased     availability of highly processed energy dense, high reward foods. Psychosocial stress and     sleep insufficiency is pervasive in industrialized societies. A growing body of evidence     suggests stress to be involved in obesity, although it is unknown whether stress is a cause     or consequence. Stress affecting dietary intake; skewing intake towards greater consumption     of highly palatable energy dense foods, also referred to as high reward foods. A causal     relationship between stress and reward seeking behavior is supported by findings from animal     studies reporting rewarding behavior by consumption of sweet tasting food in response to a     stressor.      Our aim is to investigate differences in purchases of particular food-items in free living     individuals, during a stressful (upcoming exam) and non-stressful (no upcoming exam) period.      Hypothesis: Participants will purchase more high reward foods during the pre-exam period,     compared to the control non-exam period.   "
44060|NCT02708966|"     Prediabetes (PD) was defined as an state in which glucose levels are above normal but not     enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as     impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c     (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the     prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with     IGT, it is expected that by 2035 this number will increase to 417 million people affected.     Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including:     increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose     utilization in various ways and inhibition of glucose uptake in the intestine.   "
44061|NCT02708953|"     Headaches have been listed as 1 of the 10 most disabling conditions worldwide. (Stovner et     al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these     complaints. (Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach     to the conservative care of this condition has yet to be determined. The primary aim of this     study is to determine whether individuals with CeHs will respond to a program of thoracic     spine thrust manipulation in isolation. This may further the current body of evidence by     offering an alternative, potentially safer approach to the conservative care of individuals     with this condition. Additionally, results of this study may serve to drive a larger scale     Randomized Clinical Trial (RCT) by offering information regarding feasibility of recruitment     of individuals with chronic CeHs as well as timing and dosing of the intervention.   "
44062|NCT02708940|"     This research project aims to evaluate the feasibility and effectiveness of a new approach to     tailored mobile applications using the Chorus Participatory Mobile Framework. PHP and IOP     program participants—patients and therapists--will be consented and enrolled by study staff.     Study participants will be invited to workgroups specific to their program to discuss the     usability of Chorus and be asked to complete surveys on demographics, satisfaction,     self-efficacy, and involvement with Chorus and usability of the tool.   "
44204|NCT02707094|"     The purpose of this study is to determine the efficacy of self treatment with the     Biomodulator device to decrease chronic low back pain (LBP) in active duty service members.     In addition, the study will track the use of pain medication and the impact of pain on     symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).   "
44063|NCT02708927|"     In addition to the physical, cognitive and psychological symptoms experienced by individuals     with Multiple Sclerosis (MS), there is new research which indicates that some individuals     with MS have a deficit in emotional processing, specifically, facial affect recognition.     Emotional processing is defined as a central aspect of social cognition. Models of social     cognition indicate that emotional processing is an essential component of interpersonal     relationships. The failure to accurately perceive other's emotions has been shown to lead to     difficulty in social relationships, misinterpreting other's affect, and consequently,     inappropriate responding.      However, even though a significant number of individuals with MS have impairments in     emotional processing, we do not yet have an understanding of how these impairments affect the     social functioning of individuals with MS, including the impact of these deficits on family     structure. It is well-known that MS impacts one's social functioning including factors such     as employment, daily living activities and interpersonal relationships. Recently a strong     correlation was observed between reduced social participation in MS and quality of life.     There is evidence to suggest that emotional processing deficits lie at the heart of this     reduced social participation in persons with MS, leading to decreased social functioning and     thus reduced quality of life. However, to date, this hypothesis has not been tested.   "
44064|NCT02708914|"     The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to     UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure     receiving hemodialysis.   "
44065|NCT02708901|"     The purpose of this study is to assess the effects of a 6-months supplementation with     probiotic Vivomixx® on inflammatory and gastrointestinal (GI) biomarkers, gastrointestinal     disturbances, behavioral and developmental profiles, and neurophysiological features in     preschoolers with Autism Spectrum Disorders (ASD) with or without GI symptoms.   "
44066|NCT02708888|"     The aim of this study is to further explore the effects of additional customized trunk     exercises on clinical and biomechanical gait performance. Despite of the evidence     demonstrating the importance of trunk control after stroke, studies about the effects of     trunk rehabilitation on gait performance are inconsistent. The findings of this study might     lead to new scientific insights in the importance of the trunk during gait rehabilitation in     people suffering from stroke submitted to a rehabilitation hospital.   "
44067|NCT02708875|"     Insulin resistance (or pre-diabetes) is diagnosed using the oral glucose tolerance test.     However, high blood glucose levels during this test may adversely impact on microvascular     function. Investigators will determine whether a liquid mixed meal challenge (from     carbohydrate, protein and fat) is a more appropriate test for assessing microvascular-derived     insulin resistance.   "
44068|NCT02708862|"     Four methods of preoxygenation will be compared in healthy volunteers   "
44069|NCT02708849|"     The purpose of the study is to characterize the effects of a single, sub-anesthetic dose of     ketamine in rs-fMRI in healthy subjects. Post-ketamine rs-fMRI data will demonstrate a     pattern of increased global brain connectivity (GBC) in fronto-temporal cortex.   "
44070|NCT02708836|"     Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal     tube has been shown to favorable with respect to limiting emergence phenomena such as     coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and     tachycardia.      Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher     ventilation pressures may be required, in those patients who are perceived to be high risk     for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow     the anesthesiologist to have little accessibility the airway.      The aim of this study is to investigate an airway management technique that would allow for     the benefits of the ETT in terms of a secure airway for the duration of the surgical     procedure as well the potential for less emergence phenomena seen when emerging with an LMA.   "
44134|NCT02708004|"     This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid     homeostasis in healthy subjects.   "
44073|NCT02708797|"     Migraine with aura (MA) is an independent risk factor for stroke and is associated with     silent brain infracts and T2 white matter hyperintensities on MRI. Previous studies using     Transcranial Doppler (TCD) have shown an impairment of cerebral autoregulation in MA     patients. Studies with positron emission tomography have demonstrated an activation of brain     stem areas during migraine attack. An increased density of brain stem grey matter as measured     on MRI with voxel based morphometry (VBM) has been found in MA patients. As brain arteries     and arterioles are innervated by ascending tracts from aminergic brainstem nuclei, th study     hypothesize a negative correlation between the density of brainstem nuclei and the efficiency     of cerebral autoregulation in MA patients compared with controls.      Brainstem grey matter density will be studied with a MRI Philips 3 Tesla with a 32-channel     antenna and voxel-based morphometry (VBM) cerebral autoregulation will be measured in the     time domain using Transcranial Doppler (TCD) and the Mx method.      MA patients will be studied in a headache-free period. MRI and Transcranial Doppler (TCD) are     non-invasive technics and will be performed on the same day.   "
44074|NCT02708784|"     The aim of the project is to develop new Magnetic Resonance (MR) imaging techniques for     better diagnosis and monitoring of patients with muscular disorders.      Muscle quality in patients with Late Onset Pompe Disease (Acid Maltase Deficiency type 2) and     in patients with Myotonica Dystrophy will be evaluated, by determining muscle strength in     relation to muscle size and muscle strength in relations to fat-muscle ratio.   "
44075|NCT02708771|"     Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with     acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in     serum albumin   "
44225|NCT02706821|"     The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover     human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose.     The investigators measures changes in diabetes associated parameters, including fasting blood     glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.   "
44076|NCT02708758|"     There is a lack of international uniformity in the approach to the screening and diagnosis of     gestational diabetes mellitus (GDM). The new diagnostic criteria by the International     Association of Diabetes and Pregnancy Study Groups (IADPSG) based on data from the study of     Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have created controversy because of the     lack of clinical evidence of treatment benefit for mild GDM and the treatment effects on     perinatal outcomes. The purpose of the present study is to know the efficacy of treatment to     reduce adverse pregnancy outcomes in Mexican women diagnosed with GDM by IADPSG criteria.   "
44077|NCT02708745|"     The overall goal of this project is to determine whether integrating a novel parent-report     measure of vaccine hesitancy into pediatric primary care is effective in improving acceptance     of childhood vaccines among vaccine-hesitant parents.   "
44078|NCT02708732|"     This study is a prospective, cross-sectional survey to be administered to real patients in     remission from DLBCL using a 15-minute postal or online survey. The project is designed to     describe the impact of DLBCL remission on health utility and quality of life. Data collection     will occur over a 4-month period.   "
44079|NCT02708719|"     The purpose of this study is to determine the minimal important difference (MID) for the     1-minute-sit-to-stand-test (STST) with an anchor-based method.   "
44080|NCT02708706|"     This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid     under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating     adhesive capsulitis.   "
44081|NCT02708693|"     To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of     steroid injection alone using clinical and electrophysiological parameters in patients with     carpal tunnel syndrome   "
44082|NCT02708680|"     The purpose of this study is to determine the safety and tolerability of entinostat used in     combination with atezolizumab in patients with Advanced Triple Negative Breast Cancer     (aTNBC). Additionally the purpose of the study is to assess how effective entinostat and     atezolizumab are in combination in patients with aTNBC.   "
44083|NCT02708667|"     Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug     Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung     cancer (NSCLC) and its administration has achieved considerable success. However, adverse     effects inevitably occurred and the most common one was hepatic toxicity, appearing as     elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the     investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and     explore whether there is any biological marker to diagnose this side effect in an early     stage, which may realize individualized therapy with more efficacy and less side effects.   "
44084|NCT02708654|"     Using a 2-arm, randomized controlled trial (RCT) among CHF patients at the University of     Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering     to improve outcomes among CHF patients at high risk of readmission.   "
44085|NCT02708641|"     This is a phase II study to evaluate the effect of pembrolizumab on the duration of remission     in acute myeloid leukemia. Pembrolizumab is given after complete remission is obtained in     those with AML at least 60 years old who are not candidates for allogeneic stem cell     transplant. The primary purpose of this study is determine if the time to relapse can be     extended. Additionally, the safety and tolerability of pembrolizumab will be closely     monitored.   "
44086|NCT02708628|"     To investigate the efficacy of prophylactic use of a topical gel containing extract of allium     cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the     second cesarean section.   "
44087|NCT02708615|"     This study compares two different types of speculum insertion to determine the level of     discomfort they might cause. This study compares the straight horizontal insertion (SHI) of     the speculum and the vertical insertion and rotation (VIR).      Participants are randomly assigned to one of the two insertion groups and are not told which     group they are in until the examination is over. Participants rate their level of discomfort     immediately after insertion of the speculum.      Basic demographic information (e.g., age, ethnicity, number of vaginal deliveries, menopausal     status, etc.) and clinical information are also collected to determine if other factors     influence the level of discomfort experienced.      *NOTE* This is NOT a paid study.   "
44088|NCT02708602|"     Labor and delivery is a unique physiological experience of women. Inappropriate length of     labor progress during vaginal delivery may produce great risks for mother and fetus.     Especially the slow progress is one of the most important reasons for the occurrence of     cesarean section during vaginal delivery, which still with a high incidence in recent     years.Previous studies have found that there was a significant correlation between the     genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal     delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic     receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship     between the genetic polymorphisms and labor process after labor analgesia.   "
44089|NCT02708589|"     In this study, patients undergoing the bariatric surgery will be assigned to take either     probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery.     Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will     be compared in two groups.   "
44090|NCT02708576|"     The purpose of this study is to determine the safety and tolerability of NGM313, both single     dose and multiple doses, in normal healthy overweight and obese adult participants.   "
44091|NCT02708563|"     Feasibility study to randomize non-vigorous newborn infants born through meconium-stained     amniotic fluid to endotracheal suctioning or immediate resuscitation.   "
44118|NCT02708212|"     The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However,     the optimal sequence of performing a same-day BDE has not been well-established.The primary     aims of this study are to compare the sedative doses and patient discomfort between the study     groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed     by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess     colonoscopy performance, including the cecal intubation time and adenoma detection rate     between the two endoscopic sequences.   "
44119|NCT02708199|"     Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal     follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance     Containment Tier I.   "
44092|NCT02708550|"     Epidemiological studies have shown that patient transfer is a risk factor for back pain, back     injuries and long term sickness absence, whereas consistent use of assistive devices during     patient transfer is associated with reduced risk of back injury. In consequence, Danish     hospitals have made great efforts to increase knowledge, availability and use of assistive     devices to reduce work-related physical strain due to patient transfer. Yet, a recent survey     among more than 300 nurses and nurses' aides showed that two thirds rarely uses assistive     devices during patient transfer. Thus it seems relevant to investigate barriers,     opportunities and practical solutions for increasing use of assistive devices among     healthcare workers. The purpose of this study is to evaluate a participatory organizational     intervention for improved use of assistive devices during patient transfer.   "
44093|NCT02708537|"     The hypothesis is growing semen samples with plasma rich in growth factors (PRGF), because it     could improve sperm motility in patients subsidiary TRA, ultimately improving pregnancy     rates.   "
44094|NCT02708524|"     This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational     contact lens with currently-marketed contact lenses. The objective of the study is to     evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.   "
44095|NCT02708511|"     This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography     (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer     antigen (CA)6 is an antigen (substance) found on the surface of several types of cancer cells     such as cancer of the ovary and breast. Diagnostic procedures, such as copper Cu     64-DOTA-B-Fab PET/CT, may help identify CA6 positive tumors and allow doctors to plan better     treatment.   "
44096|NCT02708498|"     The research on ageing during the last couple of decades has increasingly focused on     questions regarding the quality of life and life satisfaction of the old people. Yet the     research indicates that when it comes to the final stage of life, the end includes     unnecessary suffering and the quality of life drops. Palliative care has traditionally been     provided successfully to younger persons dying from incurable illnesses while older people     dying of multiple morbidities or old age has received far less of this type of care.     However, sixty percent of all people who died in Sweden in 2010 were at least 80 years old     and it is well known that dying among older people often is a prolonged period of suffering.     One reason might be that it is more difficult to identify when the final stages of life     begins for older persons.      The purpose of this project is to implement and evaluate how a knowledge-based model for     palliative care in nursing homes affects the quality of life and the participation in the     care process for older persons in nursing homes and their next of kin. A second aim is to     explore the staff's implementation process of palliative care and the role of the leadership.     The final aim is to investigate which factors (barriers and facilitators) that affect the     implementation process of this model.   "
44097|NCT02708485|"     The aim of this study is to evaluate the effect of a 3-month walking program on brain energy     metabolism in patient with mild Alzheimer's disease (AD). Two groups of sedentary patients     with mild AD are followed and compared over a 3-month period of time: Control (non-active)     and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks)     groups. All the participants are evaluated on their cognition, brain volumes (MRI) and brain     fuel consumption (PET scan with 18-FDG and 11C-AcAc) at the beginning and at the end of the     study.   "
44098|NCT02708472|"     This clinical trial is an investigator-initiated open label study designed to evaluate the     safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.   "
44099|NCT02708459|"     Comparing different drugs used in Transversus abdominus plane analgesia after donor     hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group,     and Dexmedetomedine group according to the used drug   "
44100|NCT02708446|"     The primary goal of this study is to directly compare repeat doses of sublingual and buccal     routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order     to determine if sublingual route confers an advantage with respect to efficacy and median     time to complete abortion.   "
44171|NCT02707523|"     The proposed study will be a randomized, double masked, placebo-controlled pilot trial of     azithromycin treatment in children with RSV-induced respiratory failure.   "
44101|NCT02708433|"     Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal     dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage     not buffered. Clinical data are needed to confirm these anecdotal data. No data exist     comparing buffered local anesthetics at lower drug concentrations to current dosages commonly     used in dental and oral surgical procedures   "
44102|NCT02708420|"     Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus     presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or     reduction of this increment is important for hemodynamic control. In this randomized single     blind study, the aim of this study is to compare the hemodynamic responses of two different     laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass     surgery patients.   "
44103|NCT02708407|"     This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically     effective treatment for patients with severe heart failure and moderate chronic kidney     disease, thus improving quality of life and symptoms.   "
44104|NCT02708394|"     This study will investigate the molecular mechanisms of atypical-antipsychotic induced     insulin resistance. This will be accomplished by administering olanzapine or placebo to     healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues     known to play an important role in insulin resistance pathophysiology.   "
44105|NCT02708381|"     The main purpose of this study is to pilot a real time electronic consultation with an     Oncogeriatric Information Team (OGIT) located at Moffitt using Total Cancer Care (TCC).     Investigators want to see for which type of patients this information is the most useful, and     work out the practical ways of making this process work.   "
44121|NCT02708173|"     This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People     Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old     and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus     Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine after     7 days.   "
44106|NCT02708368|"     CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and     includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular     diseases in the context of renal insufficiency. Clinical pictures of peripheral artery     occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours     among other main risk factors (smoking, obesity, etc.) additional cardiovascular     complications. For this reason it makes sense to monitor these patients regularly. For this     purpose the determination of different biomarkers would be appropriate for control of the     course of disease.      During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP     were established as indicators for the disease activity, as diagnostic criteria for the     existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death)     within the scope of CKD-MBD. For the clinical routine care application of these parameters     standard operating procedures (SOP) are missing for the determination method relating to     optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the     reproducibility of study results and to transfer these parameters in the clinical daily     routine for risk stratification.   "
44107|NCT02708355|"     The purpose of this pilot study is to investigate the association between gastric acid     suppression and relief of 24 hour heartburn following treatment with the proton pump     inhibitor (PPI) drug esomeprazole in frequent heartburn patients.   "
44108|NCT02708342|"     RESEARCH METHODS Study Design Observational, Retrospective, Single-center, Single-arm Study     of patients treated with raltegravir plus abacavir and lamivudine.   "
44109|NCT02708329|"     The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques     in patients with bifurcation lesions in the CTO segment.   "
44110|NCT02708316|"     Research already found that patients with autistic spectrum disorders lack of Prevotella     intestinal type, then schizophrenia patients may also show the specific intestinal type, so     investigators want to detect the gut metagenome of schizophrenia patients by high-throughput     DNA sequencing to find specific intestinal type, so as to achieve the purpose of     schizophrenia diagnosis. According to the detection of inflammatory factors in the blood,     nerve growth factor in the cerebrospinal fluid, to find the mechanism of the     gut-microbes-brain axis.   "
44111|NCT02708303|"     The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a     consistent evaluation tool for patients undergoing foregut surgery in order to standardize     and validate outcome measures.   "
44112|NCT02708290|"     Visual puzzles have been used for centuries to facilitate early development in kids. Mental     Imagery Therapy for Autism (MITA) is a unique, early-intervention application for children     with Autism Spectrum Disorder (ASD). The app includes bright, interactive puzzles designed to     help children learn how to mentally integrate multiple features of an object, an ability that     has proven to lead to vast improvements in general learning. Success with MITA puzzles could     overtime result in significant improvements in a child's overall development, specifically in     the realms of language, attention and visual skills.      SCIENCE BEHIND THE PROJECT:      MITA is based on Pivotal Response Treatment (PRT), one of the best-supported therapies for     children diagnosed with ASD. MITA aims to develop one of four pivotal skills targeted by PRT:     a child's ability to notice and to respond to multiple visual cues presented simultaneously.     This ability is typically impaired in individuals with autism, leading to what is commonly     described as stimulus overselectivity, or tunnel vision. Improving the capacity to discern     and respond to multiple cues has been shown to reduce stimulus overselectivity, which in turn     leads to vast improvements in general learning.      The visual exercises follow a systematic approach for developing a child's ability to notice     multiple characteristics, or features of an object. MITA starts with simple exercises that     teach a child to attend to only one feature, such as size (see screenshot 1) or color     (screenshot 2). Over time, the exercises get more difficult and require the child to attend     to two features simultaneously, such as both color and size (screenshot 3). In order to solve     these puzzles, a child must learn how to hold two pieces of information in their mind (both     the size and the color of an object) and make a decision based on the combination of these     features. Once a child has practiced attending to two features, the program moves on to     puzzles that require attending to three features, such as color, size and shape (screenshot     4), and then eventually to puzzles that involve attending to an ever-increasing number of     characteristics.      As a child progresses through MITA's systematic exercises, he or she is developing the     ability to simultaneously attend to a greater number of features, reducing the propensity     towards tunnel vision, and thus developing an essential component of language. The ability to     mentally build an image based on a combination of multiple features is absolutely necessary     for understanding syntax, spatial prepositions and verb tenses.      MITA is designed for early childhood and intended for long-term, daily use. It is designed to     be engaging and educational, as well as adaptive and responsive to the individual abilities     of each child.   "
44113|NCT02708277|"     The purpose of this study is to compare the outcome of loop intrauterine contraceptive device     and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine     adhesions in patients with infertility.   "
44114|NCT02708264|"     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many     countries, including the United States. Multiple gestations are at increased risk of SPTB. A     short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good     predictor of SPTB, in both singletons and twins.      The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of     the cervical pessary has been assessed in several populations including singletons with short     CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized     clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on     use of the cervical pessary in pregnancy or guidelines for management have been assessed.   "
44115|NCT02708251|"     The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive     method that may be underutilized due to fear of pain during insertion. Although providers     frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there     is no evidence for any pain reduction. Women can experience high levels of pain when the IUD     is placed inside the uterus, and fear of this pain could be a reason that women decide not to     use this method.   "
44116|NCT02708238|"     A multicenter prospective, randomized comparative study will be conducted in infants with     colic, according to Rome III criteria. Enrolled infants will be assigned at random to receive     Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), L reuteri DSM     17938 (108 CFU) or simethicone. Treatment will be given to subjects for 28 days and they will     be followed for 4 weeks. Treatment success will be assessed at the end of study period. Daily     crying and fussing times will be recorded in a structured diary, and maternal questionnaires     will be completed to monitor changes in infant colic symptoms and adverse events.   "
44117|NCT02708225|"     Medical clowns are known to assist in relaxing children and allowing better cooperation     during performance of medical procedures.      The ability of medical clowns to improve the motivation of children to perform active tasks     was never examined to date.      The investigators would like to examine the influence of the clowns' presence on the     performance of pulmonary function test.   "
44123|NCT02708147|"     This study aims to evaluate the recovery of children with bronchiolitis with and without     physical therapy treatments.      The experimental group will receive educational information and 5 sessions of physiotherapy     with the same protocol, at home or in physical therapy office. The control group will only be     evaluated.      For both the experimental and control groups the lung sounds are recorded and the Wang's     respiratory severity scale calculated initially and on the 3th, 5th and 21st days and     computorized. After 3 months of the initial contact, there will be an interview by the phone     about relapses or other clinical signs of bronchiolitis until then.      It is expected that the children receiving physiotherapy have a better recovery than the     control group.   "
44124|NCT02708134|"     This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests.      The purpose of the study is to determine the association between chest compression mechanics     (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the     investigators will determine the association of post cardiac arrest care with patient     outcomes.   "
44125|NCT02708121|"     This pilot trial will test feasibility and acceptability of a primary care-based intervention     that aims to increase the portion of patients who enter evidence-based behavioral weight loss     treatment.   "
44126|NCT02708108|"     This study tests the ability of a focused dietary, exercise, and activity intervention to     reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to     improve disease response and reduce toxicity.   "
44127|NCT02708095|"     The main purpose of this study is to evaluate the efficacy and safety of the study drug known     as baricitinib in participants with systemic lupus erythematosus.   "
44128|NCT02708082|"     Study consists of five visits over a one to three month time period.   "
44129|NCT02708069|"     The goal of this project is to develop and test e-Unstuck, an e-learning intervention that     (1) provides advanced training to parents of children with Autism Spectrum Disorder without     Intellectual Disability (ASDwoID) on how to implement the evidence-based Unstuck and On     Target (UOT) curriculum at home and (2) is built on 3C's proprietary, state-of-the-art,     Dynamic e-Learning Platform, an established platform with high ratings of quality, value,     usability, and feasibility from end users. As a result of the pilot efficacy test, the     investigators hypothesize that (1) parents who interact with the e-Unstuck software will     report greater knowledge and use of UOT principles, less parenting stress and greater     parenting sense of competence, and improved child executive function (EF) and social skills     compared to control parents, (2) parents who spend more time engaged with the intervention     will show greater improvements in outcome variables, and (3) parents who interact with the     e-Unstuck software will find the software to be of high quality, value, usability, and     feasibility.   "
44130|NCT02708056|"     The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing     profound neuromuscular block induced by rocuronium in infant patients   "
44131|NCT02708043|"     The current study retrospectively assesses laryngeal mask airway use during pediatric     adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction     levels.   "
44132|NCT02708030|"     This randomised trial is undertaken to assess whether MAD or LGIT is non-inferior to KD with     regard to seizure control at twenty-four weeks among children with drug resistant epilepsy.     The hypothesis of the study is that in 1 to 15-year-old children with drug resistant     epilepsy, use of Modified Atkins Diet (MAD) or Low Glycemic Index Therapy (LGIT) as an add on     to the ongoing anti-epileptic drugs would not be inferior to ketogenic diet by >15% in terms     of seizure reduction from baseline seizure frequency at 24 weeks.      The primary outcome of the study is to determine the efficacy of MAD as compared to KD and     LGIT as compared to KD for seizure reduction in drug resistant epilepsy following 24 weeks of     dietary therapy in 1 to 15-year-old children on anti-epileptic drugs. The change in seizure     frequency will be estimated as percentage change in seizure reduction at 24 weeks as compared     to baseline.   "
44133|NCT02708017|"     The purpose of this study was to compare the analgesic efficacy of the ultrasound guided     bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for     postoperative analgesia after laparoscopic cholecystectomy   "
44135|NCT02707991|"     Effective all-oral medications are finally available to cure hepatitis C virus, which affects     more than 4 million Americans and one-in-four people living with HIV. However, many barriers     exist that prevent people with HIV/HCV co-infection from getting this curative treatment,     including low knowledge, competing demands, and drug interactions with HIV medications.      This study evaluates if a hepatitis C nurse case management intervention in an HIV primary     care clinic will improve patient attendance to hepatitis C care and help people start     hepatitis C treatment earlier. Half of the participants will receive brief case management     with a nurse, while the other half will receive usual clinic care.   "
44136|NCT02707978|"     The purpose of this research study is to evaluate tau distribution in the brain of subjects     with: FTD caused by different genetic mutations, any mutation carriers (with or without     symptoms), any non-mutation carrier, any sporadic FTD, normal controls.   "
44137|NCT02707965|"     Some epilepsy patients are described as GB when they have worsened seizures or side effects     related to switching between brand name and generic, or between generic antiepileptic drug     (AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible     reasons for patient problems with the drug switching. Factors that will be studied in GB     epilepsy patients include physiologic, psychological, and genetic factors, including in this     protocol whether brand and generic AEDs are pharmacokinetically similar in GB individuals.   "
44138|NCT02707952|"     The purpose of this study is to evaluate the efficacy and safety of ABT-493/ABT-530 in     Japanese adults with chronic hepatitis C virus infection.   "
44139|NCT02707939|"     Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the     world. Approximately 1% of the population worldwide is affected by this disorder. Children     with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on     very rigid and predictable schedules and routines. Any changes in their schedules can often     trigger negative emotional outbursts. The need to come to the hospital for procedures can be     one such trigger. The purpose of this study is to examine the post anesthesia behavior     outcomes of children with ASD.   "
44140|NCT02707926|"     Hypothesis:      Antiretroviral drugs (ARVs) with enhanced LT penetration characteristics in vitro and in     macaques will translate into an ARV regimen with increased LN and GALT concentrations and a     faster decay and more potent suppression of HIV replication in LT in HIV-infected persons.      Objectives:        1. Determine lymph nodes (LN) and gut-associated lymphoid tissue (GALT) pharmacokinetics          (PK) in HIV-infected persons on an antiretroviral drug (ARV) regimen.        2. Determine virological responses of antiretroviral therapy in plasma, peripheral blood          mononuclear cells (PBMCs) and lymphoid tissue (LT).   "
44141|NCT02707913|"     The purpose of the study is to compare the bioavailability of a generic product of amlodipine     with that of a reference product when administered to healthy volunteers under fasting     conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future     Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the     reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine     obtained from two formulations will be used to access the interchangeability of the products   "
44142|NCT02707900|"     The purpose of this research study is to 1) evaluate the safety of a series of injections     with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help     scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the     immune system can be made stronger to eliminate the activated HIV virus.   "
44143|NCT02707887|"     The purpose of this study is to:        1. determine if a smartphone enhanced treatment for LETS ACT (LETS ACT-SE) is associated          with increased long term treatment engagement, and in turn, improved long term treatment          outcomes, and        2. use functional magnetic resonance imaging (fMRI) to identify the effects of LETS ACT-SE          on the neuromarkers of reward sensitivity.   "
44144|NCT02707874|"     This is a clinical study to investigate and compare a new programmed intermittent bolus (PIB)     delivery method for continuous popliteal sciatic nerve block for pain relief in patients     undergoing major ankle surgery compared with the current practice of continuous local     anesthetic infusion (CI).   "
44145|NCT02707861|"     Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system     cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in     combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited     treatment options. This study will collect further information on the safety and tolerability     of intravenously administered (IV) ibalizumab combined with an optimized background regimen     for treating multi-drug resistant HIV-1 infection, and will provide continuing access to     ibalizumab for patients completing a prior ibalizumab clinical trial.   "
44146|NCT02707848|"     This 3-year school-based epidemiological study on child and adolescent mental disorders aims     to obtain the prevalence rate and identify the psychosocial, individual, environmental, and     familial risk factors for mental disorders including learning disability, autism spectrum     disorder, attention-deficit hyperactivity disorder, oppositional defiant disorder, conduct     disorder, mood disorders (major depression, dysthymia, bipolar disorder), anxiety disorders,     phobia, obsessive compulsive disorder, sleep disorders, eating disorders, and substance use     disorders in Taiwan.   "
44147|NCT02707835|"     The ultrasound imaging could be used to examine the thickness of dermis and the space between     dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to     other measurement of edema is unknown.      The purpose of this study is to investigate        1. The reliability of measurement of edema using ultrasound imaging, and the correlation of          measurement of ultrasound with other measurement tools.        2. The different effect of edema control by manual lymph drainage technique and epidermis          taping technique, and the cost-effective assessment.      Our hypothesis :        1. The measurement of edema with ultrasound imaging is a reliable method and correlate with          other edema measurement with moderate correlation.        2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and          epidermis taping, and different cost-effectiveness analysis.   "
44148|NCT02707822|"     The purpose of the study is to identify factors that may influence tacrolimus (TAC)     pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on     pharmacokinetics of TAC in Taiwanese.   "
44149|NCT02707809|"     The microcirculation is altered in acute kidney injury and chronic kidney disease. The     microcirculation is poor in end-stage renal disease patients receiving hemodialysis. Kidney     transplant can improve the life quality of these patients. However, surgical stress and     inflammatory response may cause microcirculatory dysfunction and intestinal injury. Moreover,     the transplanted kidney would suffer from the ischemia and reperfusion injury, and it may     result in acute kidney injury. In ischemia and reperfusion injury animal model,     dexmedetomidine has been proven to attenuate kidney and intestinal injury. In our previous     study of surgical stress and pain stimulation rat model, we found that dexmedetomidine     attenuate the intestinal microcirculatory dysfunction. In patients receiving coronary artery     bypass graft surgery, dexmedetomidine increases urine output and decreases postoperative     serum level of neutrophil gelatinase-associated lipocalin.      This study aims to investigate whether perioperative dexmedetomidine infusion may attenuate     microcirculatory dysfunction, kidney injury, and intestinal injury for patients undergoing     kidney transplant.   "
44150|NCT02707796|"     Oxygen reserve index (ORI) measured by multiple wave pulse co-oximeter is a new technological     development in medical science. Our aim in this study is to identify the correlation between     arterial oxygen pressure (PaO2) and ORI, and to identify the specificity and sensitivity of     ORI as a tool to prevent hypoxia and hyperoxia in abdominal surgery patients.   "
44151|NCT02707783|"     The aim of the study is feasibility of complete coronary revascularization with bioresorbable     vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of     consecutive patients with stable and unstable angina in Russian population.      The hypothesis of this registry study: 1) Complete coronary revascularization with BVS     implantation will be feasible to perform in at least 70 percent of patient population with     stable and unstable angina qualified for revascularization after coronary angiography, 2)     Complete revascularization with BVS is as safe and effective as revascularization with     standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published     literature comparators in matched populations).      Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres.     12 month clinical observation and 5-year clinical follow-up is expected.   "
44152|NCT02707770|"     Pulmonary rehabilitation (PR) is an exercise program tailored for patients with chronic lung     disease that is a core part of the management of patients with Chronic Obstructive Pulmonary     Disease (COPD). Many COPD patients develop low oxygen levels (desaturation) during exercise     and this is often discovered when they are being evaluated for PR. Current practice is to     administer oxygen to COPD patients with exercise-induced desaturation, but this is based on     very limited evidence. This limited evidence relates to a short-term increase in exercise     capacity and it is not known if this translates into longer term increases in activity or     whether providing these patients with oxygen improves outcomes after PR.      In addition it is not known if patients given ambulatory oxygen continue to use it after     completing PR. Evidence for a beneficial effect of oxygen would provide a more solid evidence     base for its use. Conversely demonstration of no effect would allow reassessment of the use     of oxygen and whether the costs are justified. Therefore the aims of this study are to assess     the effects of oxygen on outcomes from PR and assess the usage of ambulatory oxygen following     completion of PR.   "
44153|NCT02707757|"     Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two     current possible treatments for anaemia which are iron and erythropoietin stimulating agents     (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and     haemoglobin, but these markers are known to be inaccurate. The current clinical protocol     therefore tends towards overuse of both agents which can be associated with toxicity, and the     reliance on these markers prevents retrospective assessment of treatment responsiveness. This     study is designed to investigate the factors which predict which agent would produce a better     response. Patients with a fall in haemoglobin will be given treatment with either iron or an     increased dose of ESA as they are currently, but allocated at random rather than by poorly     performing biochemical markers. The iron treated and ESA treated groups can then be analysed     for factors which predict response in o   "
44154|NCT02707744|"     It is an observational study in patients with heart failure investigating the incidence of     arrhythmias using a wearable device which can monitor heart rhythm for up to 14 days. In     addition to gathering routine clinical information, research assessments include a symptoms     questionnaire and a corridor walk test. Patients will be followed for clinical events     (interventions for arrhythmias, hospitalisation, death) for up to 5 years.   "
44155|NCT02707731|"     This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing     stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol     samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart     rate, respiratory rate and oxygen saturation before and after hydrotherapy.   "
44156|NCT02707718|"     Monocentric prospective study on consecutive patients attending the emergency department and     suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of     interest in sepsis.   "
44157|NCT02707705|"     Preoperative anxiety before cesarean section is common and may be severe. Stress consequences     are often deleterious for the mother and for the upcoming newborn. Means to reduce anxiety     before cesarean section are limited. Anxiolytic drugs are avoided in the context of the birth     of a newborn. Auricular acupuncture has been shown to relieve anxiety disorders. The aim of     this study is to evaluate the anxiolytic effect of auricular acupuncture administered before     an elective cesarean section. Anxiety will be measured at T0: inclusion (approximately 1-2     hours before cesarean section) and T1: departure to surgical unit (approximately 30 minutes     to 1 hour after T0). Patches (needle or needle-free) will be set up at T0 just after the     initial anxiety assessment (anxiety Visual Analog Scale aVAS).   "
44158|NCT02707692|"     The purpose of this study is to determine the impact of Pneumococcus and Influenza vaccines     on the HIV transcriptional activity in individuals who are virologically suppressed for at     least 48 weeks on similar ART. The proposed study is a randomized double-blinded control     trial conducted over 28 weeks. Randomized interventions will be injections of Influenza     vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but     in a randomized order.   "
44159|NCT02707679|"     Patellofemoral Pain Syndrome (PFPS), also known as the anterior knee pain, is one of the most     common musculoskeletal disorders. Most of the patients suffer from knee pain for long time.     The aim of this study was to investigate the short-term effects of Mobilization with movement     and Kinesiotaping on pain, function and balance in patient with PFPS.   "
44160|NCT02707666|"     This is a single institution, single-arm, window of opportunity pilot trial of pembrolizumab     in patients with resectable malignant pleural mesothelioma. All patients will undergo a     pretreatment PET/CT scan for clinical staging and a VATS procedure to acquire pretreatment     tissue. Three cycles of pembrolizumab will then be administered (200 mg IV every 21 days). A     PET/CT scan will then be repeated to assess response to pembrolizumab and then surgical     resection will be performed via an extended/pleurectomy decortication at least 4 weeks after     the third dose of pembrolizumab. Standard adjuvant chemotherapy consisting of cisplatin and     pemetrexed for 4 cycles (every 21 days) will be given starting about 6-8 weeks following     surgery, after a new baseline CT scan is obtained. Restaging CT scans will be obtained to     assess response after every two cycles of chemotherapy. After the completion of standard     chemotherapy, optional adjuvant treatment with pembrolizumab will be given to eligible     patients for 1 year post-surgery.   "
44161|NCT02707653|"     This study will investigate the use of misoprostol for first-line treatment of incomplete     abortion at tertiary hospitals in Myanmar.   "
44162|NCT02707640|"     This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study     of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary     fibrosis (IPF) receiving background pirfenidone therapy.   "
44185|NCT02707341|"     The primary objective of the Corrona Psoriasis Registry is to study the comparative safety of     approved psoriasis therapies in a national cohort of psoriasis subjects treated by     dermatologists. This includes assessing the incidence and nature of adverse events of special     interest, including malignancy, in a real world population of psoriasis patients on new     biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the     epidemiology and natural history of the disease, comorbidities, current treatment practices,     and comparative effectiveness.   "
44186|NCT02707328|"     This study is looking at determining the maximum safe dose of CyberKnife when given with     chemotherapy for unresectable adenocarcinoma of the pancreas.   "
44163|NCT02707627|"     A new era of outcomes for pediatric burn patients has begun as burn care continues to     improve. Unfortunately, complete restoration of burn-injured skin may be limited by the     development of hypertrophic scarring. Treatment with ablative fractional carbon dioxide laser     therapy is one of the newest forms of scar therapy available. Although laser therapy has only     been adopted by burn clinicians within the last several years, early evidence suggests that     it may offer significant benefits. At present, a well-designed randomized controlled trial     that evaluates the effectiveness of laser therapy for improving hypertrophic burn scars in     children has not yet been conducted. Thus, the proposed study will answer the following     research question: In children aged 1 to 18 years with a hypertrophic burn scar, is the     addition of ablative fractional carbon dioxide laser therapy to standard scar management more     effective at improving the appearance and texture of the scar compared to standard scar     management alone, as measured by the Vancouver Scar Scale from baseline to month 12?     Ultimately, the completion of this study may lead to a fundamental change in the standard     treatment of pediatric hypertrophic burn scars. In addition, the study findings will also be     applicable to children and adults with scars resulting from other etiologies.   "
44164|NCT02707614|"     This study aims to describe the postoperative functions of patients after undergoing open or     robotic prostastectomy. Primary endpoints will focus on complications in the post-anaesthesia     care unit (PACU) which prevent dischard from PACU to the general ward. This include Aldrete     scores and other complications that can be registrered descriptively. Furthermore, the study     seeks to compare what influence open versus robotic prostastectomy have on peri- og     postoperative complications.   "
44165|NCT02707601|"     This study will evaluate efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) as measured by the     proportion of participants achieving hepatitis C virus (HCV) RNA below the lower limit of     quantification (LLOQ) 12 weeks after the last dose of LDV/SOF (sustained virologic response     (SVR) 12).      This study will consist of 2 parts. In Part 1, the participants will be randomized to switch     from stable antiretroviral (ARV) therapy to either E/C/F/TAF or F/R/TAF. The participants     maintaining HIV-1 RNA < 50 copies/mL and tolerating E/C/F/TAF or F/R/TAF through Part 1 will     continue to Part 2 where they will receive the LDV/SOF treatment.   "
44166|NCT02707588|"     The general aim of the study is to evaluate the anti-tumour activity and the tolerance     profile of Pembrolizumab + RT in comparison to cetuximab + RT in patients with locally     advanced HNSCC and to explore potential correlations between treatment outcome and the immune     landscape.   "
44167|NCT02707575|"     The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes     with exudative age-related macular degeneration (AMD) before therapy with intravitreal     Ranibizumab, and identify associations with visual and anatomical outcome after treatment.   "
44168|NCT02707562|"     32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting     of three consecutive treatment periods: two 1-week periods followed by one 2-week period,     evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days     follow-up period.      During the course of the study, subjects will be examined for any side effects that may occur     (safety and tolerability).      Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in     pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837     present in the blood (pharmacokinetics) will also be determined.   "
44169|NCT02707549|"     Fluid management of children during neurosurgery is not well established. Hypotonic     solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse     operative conditions. This study compares two different isotonic solutions administered     perioperatively regarding acid base and fluid electrolyte disturbances.   "
44170|NCT02707536|"     The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in     extraction socket healing with or without particulate bone graft. The hypothesis of this     study is that PRF will enhance the extraction socket healing and new bone formation when     compared to extraction sockets grafted without PRF.   "
44172|NCT02707510|"     The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency     And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and experiences     from an inter-professional perspective to mitigate distress among patients with an advanced     cancer diagnosis. GRACE is a six-session, empirically anchored intervention emphasizing a     Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach involving     psycho-education and process-oriented experiences. The curriculum includes themes illustrated     via PowerPoint slides with semi-structured delivery, video presentations, a variety of     mindfulness meditation practices, and selected readings that serve to reflect and capture the     theme for the week of the curriculum.   "
44173|NCT02707497|"     The purpose of this study is to determine whether recombinant human thrombopoietin(rhTPO) can     rapidly increase the platelet counts, shorten the time of the platelet returned to normal,     reduce platelet transfusion and bleeding events, decrease the length of ICU stay, and     eventually reduce the 28-day mortality in septic shock patients with thrombocytopenia.   "
44174|NCT02707484|"     Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or     chronic gastrointestinal bleeding, currently lacks of effective treatment. The investigators'     previous study first confirmed thalidomide treatment of GIVM bleeding was safe and effective.     This prospective multi-center randomized controlled clinical trial intends to investigate the     efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM.   "
44184|NCT02707354|"     Gastro-intestinal graft versus host disease (GVHD) is a major source of morbidity and     mortality amongst allogenic hematopoietic stem cell transplantation (Allo-HSCT). The     diagnosis is based on histological findings that involve colonic biopsies with a risk of     bleeding, especially in case of thrombocytopenia. Moreover the diagnosis is frequently made     at a clinical stage of the disease, after the appearance of gastro-intestinal symptoms.     Endo-microscopy is a novel endoscopic technique that allow optical biopsies during a     conventional endoscopy and has proved its efficiency in several indications. In a pilot study     the investigators showed that it had good sensibility and sensitivity compared to histology     as gold standard. Therefore this study aim to identify endo-microscopic criteria allowing the     early diagnosis of GHVD before its clinical manifestations.   "
44175|NCT02707471|"     Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent     recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone     receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in     our preliminary work, 65% of breast cancer patients taking AET reported one or more     non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the     past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly     related to non-adherence and early discontinuation of treatment. Poor adherence to AET due to     symptoms may compromise the effectiveness of AET. Prior to conducting a clinical trial, we     will conduct user testing of the self-management intervention protocol with 20 women. In the     proposed randomized clinical trial, 400 women who are taking AET for breast cancer will be     randomly assigned to one of two conditions: 1) a self-management intervention for improving     adherence and symptom management, or 2) a general health education control condition. The     self-management intervention integrates three key theory-based strategies for improving     adherence to AET: coping skills training for managing symptoms (e.g., arthralgia, vasomotor     symptoms), behavioral strategies for improving medication adherence, and symptom and     medication education. The intervention addresses the specific symptoms a woman is     experiencing and is designed to meet the needs of women who are at high risk for     non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management     intervention is administered by a nurse via the telephone, and combines the use of phone     calls and tailored interactive voice messaging based on information exchanged during phone     sessions and real-time adherence data obtained from smart medication bottles. Women randomly     assigned to the control condition will receive a general health education intervention that     is delivered by a nurse via the telephone. This study will take place in the Duke Cancer     Institute breast clinic and in community hospitals that are members of the Duke Cancer     Network, which will allow access to women receiving care outside the medical center setting     and increase generalizability of findings to a variety of settings. Adherence to AET will be     assessed over the 18 month period following study enrollment using wireless smart medication     bottles that provide real-time adherence data. Patient-reported outcome measures assessing     symptoms, perceived necessity of AET, concerns about AET, and self-efficacy will be obtained     at baseline and 3, 6, 12, and 18 months. To increase the likelihood of later implementation     of the self-management intervention, the cost effectiveness of the intervention will be     evaluated.   "
44176|NCT02707458|"     DEPEND is an open-label but dosage-masked trial of the retired cholesterol-lowering drug     probucol as an agent to increase availability of apolipoprotein E (apoE) in the cerebrospinal     fluid (CSF) of cognitively intact older persons at risk of Alzheimer's dementia. Absorption     of oral probucol is variable. In a sample of 23 cognitively intact persons over age 55,     DEPEND will therefore develop an algorithm to prescribe individualized dosing to achieve     plasma concentration that will likely increase availability of CSF apoE. These persons will     then use their individualized dosage for 12 months to assess longer-term effects of the drug     on CSF apoE concentration, while monitoring closely for evidence of adverse consequences of     use.   "
44177|NCT02707445|"     This study evaluated epidemiology and clinical outcome of clopidogrel related various     genotyping in Korean patients who had undergone percutaneous coronary intervention as a all     comer registry form.   "
44178|NCT02707432|"     The study will determine the feasibility and efficacy of adapting an evidence-based     intervention (EBI) to reduce cardiovascular disease (CVD) risk factors in rural African     American communities and determine the acceptability of mobile technology in these     communities to support behavior change.   "
44179|NCT02707419|"     Postoperative rehabilitation is required for a successful outcome following total knee     arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to     strengthen quadriceps, to restore normal gait, and to recover independence in activities of     daily living. In the last decade action observation treatment, in addition to conventional     physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is     growing evidence of the applicability of action observation training in rehabilitative     medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of     cerebral palsy and of aphasia.      Nevertheless those are small studies and one of them included a mixed population of hip and     knee arthroplasty.   "
44180|NCT02707406|"     The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft.      The purpose of the study is to evaluate the safety, incidence and rate of wound closure     following application of the product compared to standard of care in the treatment of     difficult to heal diabetic foot ulcers.   "
44181|NCT02707393|"     In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation     (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors     (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen (RIC),     consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related     mortality and toxic late effects. Strict post-transplant monitoring and reintroduction of TKI     as well as donor lymphocyte infusions (DLI) in case of relevant residual disease are part of     the protocol.   "
44182|NCT02707380|"     This study is designed to investigate the effect of a structured resistance training program     on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type     2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator     will compare the experimental group receiving resistance training to a control group made of     patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise     modalities during their sessions, which is the current standard of care.   "
44183|NCT02707367|"     Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning is a     highly interactive web-based tool that provides guidance for providers and people in     recovery, and promotes widespread implementation of Person-Centered Recovery Planning (PCRP).     The Recovery Roadmap prototype was developed and tested by the Center for Social Innovation     (C4), in partnership with Yale University's Program for Recovery and Community Health (PRCH),     under a Phase I Small Business Innovative Research (SBIR) grant funded by the National     Institute of Mental Health (NIMH) (1R43MH100712). Phase II will refine the prototype Roadmap     to streamline content, provide additional handouts and exercises for providers and clients to     complete together, expand the audio/video vignettes and case studies, and add interactive     online coaching and support for providers. Phase II also involves a robust evaluation of the     Roadmap, using a quasi-experimental design in a fully powered trial. Approximately 26     community-based mental health programs will be randomized into Recovery Roadmap (RR) or     Illness Management and Recovery (IMR) conditions [in New York study sites, this practice is     referred to as Wellness Self-Management (WSM)]. Participants will include both providers and     clients, and data will include one pre-test and three post-tests with providers and clients,     interviews with providers and administrators, network analytics, and administrative client     data. This phase will culminate with the dissemination of findings and preparation for Phase     III commercialization.   "
44187|NCT02707315|"     This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the     treatment of potentially resectable adenocarcinoma of the pancreas   "
44188|NCT02707302|"     The purpose of this study is to support the rational use of iodophor-impregnated surgical     adhesive drapes for preventing wound infections after total hip arthroplasty.   "
44191|NCT02707263|"     The primary purpose of this study is to demonstrate that a continuous infusion of intravenous     (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic     levels of heparin in high-risk critically ill medical patients as compared with guideline     recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the     anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used     to demonstrate that Intravenous administration is more effective.   "
44192|NCT02707250|"     Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by     considerable pain after surgery. More recently transversus abdominis plane (TAP) block was     extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The     subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable     supraumbilical analgesia.   "
44193|NCT02707237|"     Providing verbal counseling supplemented with both written and pictorial information then     verbal counseling alone is a more effective method of counseling parents with threatened     preterm delivery   "
44194|NCT02707224|"     A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of     DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in     comparison to each component administered alone in healthy male volunteers   "
44195|NCT02707211|"     To test whether active pneumococci immunization can alleviate inflammation and improve     cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic     disorders.   "
44196|NCT02707198|"     This study is being conducted to investigate the potential benefits of probiotic intake for     preventing antibiotic associated diarrhea and Clostridium difficile infection in patients     undergoing a systemic antibiotic treatment. The primary research question is: can daily     intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea     and Clostridium difficile infection in patients during antibiotic treatment?   "
44197|NCT02707185|"     METHODS:      Subjects:      All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents     and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and     training in CPR techniques according to their department training policy.      Study Assessment Tool:      An objective assessment tool has been developed and tested in medical code scenarios during     training sessions recently done in the simulation lab. The tool has five domains: Airway,     Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists     of 3-8 tasks and skills (attachment A).      Design:        -  Phase I: In groups of five to six subjects, residents and nurses will undergo baseline          assessment in CPR techniques in the simulation lab. Subject will be presented with a          clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by          observers based on the previously described assessment tool and will be video recorded.        -  Phase II: All study subjects who completed phase I assessment will undergo standardized          debriefing and demonstration of proper CPR techniques after reviewing their individual          baseline videotape followed by repeated demonstration in CPR techniques during a          clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge retention          will be assessed periodically.        -  Phase III: Rates of survival to hospital discharge and survival at 24 hours in          hospitalized patients after cardiopulmonary arrest collected by the CPR committee and QA          department longitudinally for one year after completion of project training (phase II)          will be reviewed and compared to the same period one year earlier (CPR outcome data are          being collected since 2005 at St. Luke's-Roosevelt Hospitals).   "
44198|NCT02707172|"     The aim of the study is to evaluate the effectiveness in removing chemical exposure on hand,     the investigators compare removal efficiency of Di-(2-ethylhexyl)phthalate (DEHP) on hands by     hand washing with soap and water vs. water only. In two three-day N-of-1 trials, residual     DEHP was measured in a single female adult who washed exposed hands with soap-and-water or     water-only. Subsequently, a crossover study was performed by randomly assigning another 28     subjects equally to wash with soap-and-water or with water-only, and then each one received     the other treatment 24 hrs later.   "
44199|NCT02707159|"     The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of     diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%.     Treatment with chemotherapy can improve efficacy, but still the median progression-free     survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median     overall survival is less than one year. There is a urgent need for tools for predicting the     efficacy of the treatment. The current trial aims at investigating the biomarker potential of     circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by     gemcitabine and nab-paclitaxel.   "
44200|NCT02707146|"     This project focuses on improving the patient-provider primary care visit interaction by     addressing the need to align patient and provider priorities in a way that incorporates     patients' goals and preferences while supporting the clinical work of their providers.   "
44201|NCT02707133|"     Choroidal nevomelanocytic lesions have a high prevalence affecting up to 7% of the entire     population and are increasingly incidentally identified during routine eye check- ups in     community optometry services. Given the tendency to err on the side of caution, there is     evidence of excessive referrals challenging service delivery in both tertiary eye units and     specialist ocular oncology services. Although previous studies have examined the natural     history and risk factors for growth of choroidal nevomelanocytic lesions, optimal delivery of     management remains uncertain. Management approaches display diversity with respect to the     number and type of baseline investigations, the duration and frequency of monitoring of     relevant patients. Utilisation of the skills of allied health professionals in appropriate     cases would allow streamlining service delivery in a socialised healthcare system, maximise     capacity, and allow community services to play an enhanced role. However, the evidence for     this model of delivery is lacking. Within existing models of care for these lesions, patients     are faced with delays, need for more than one attendances to the hospital and increased     anxiety around prognosis.      This project aims to answer the question of whether these low-risk, bland incidental findings     might possibly be managed by allied health professionals with the use of clinical imaging and     specific algorithms to make appropriate management decisions. We aim to validate a model of     service delivery on a virtual basis that will accommodate for capacity pressures to accept     all relevant referrals, while offering a safe service and optimising patient experience of     care. We will thus validate the setting up of a virtual choroidal nevomelanocytic clinic in     terms of safety and patient acceptability. More specifically, the degree of agreement between     management decisions made by non-medical graders on the basis of imaging data alone as     opposed to gold standard decisions (clinical and imaging tests combined) is examined. Health     economics analysis of the proposed service delivery model will be undertaken to demonstrate     cost-effectiveness.   "
44205|NCT02707081|"     Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV)     lidocaine infusion for postoperative pain control after cesarean section.      Study design: prospective randomized, double-blind, placebo-controlled study. Patients and     methods: Initially, 165 pregnant full-term females, indicated to be underwent elective     cesarean delivery for various indications were randomized equally to either group C (control,     IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV     (intravenous lidocaine infusion).Five patients were excluded from each group for various     reasons. The outcome measures were postoperative pain scoring, total pethidine consumption     and the need for postoperative analgesia.   "
44206|NCT02707068|"     This study seeks to test the feasibility of a self-management manual with minimal telephone     support by a healthcare professional. The study will also explore the acceptability of the     intervention manual to patients.   "
44207|NCT02707055|"     Background:      Hormones are naturally occurring chemicals in the body. Ghrelin is a hormone that stimulates     appetite. It may also stimulate alcohol cravings and use. Researchers want to learn more     about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings.      Objective:      To test if the drug PF-05190457 decreases alcohol craving.      Eligibility:      People ages 18 65 who have:      Alcohol use disorder      No other serious medical problems      Woman must be postmenopausal or have had surgery to prevent pregnancy.      Design:      Participants will stay on the inpatient unit here at the Clinical Center for two 2-week     stages, which will be separated by at least 2 days. The inpatient phase include:      Taking the study drug or placebo by mouth twice daily      Blood tests      Tasting several sweet solutions      Physical exams      Smokers will smoke cigarettes through a device that gives information about how they smoke a      cigarette.      Exposure to alcohol, water, and food cues in a bar-like room. Participants answer questions     on a computer.      Blood pressure and heart rate are monitored through an arm cuff and sensors on the chest.     Saliva is collected      through cotton rolls in the mouth.      MRIs: Participants lie on a table that slides in and out of the cylinder, and a coil is     placed over the head.      They complete tasks on a computer screen while in the cylinder. This lasts up to 2 hours.      Wearing a virtual reality headset, walking around a virtual room, and selecting virtual food     and drink.      Participants will have 8 hour long follow-up visits in our Outpatient Clinic These include:      Counseling to abstain from alcohol use. Sessions may be videotaped.      Physical exams   "
44208|NCT02707042|"     More than 250 million courses of antibiotics are prescribed annually in the ambulatory care     setting in the United States alone, including more than 40 million in children under 18 years     of age. The perception that antibiotic use has minimal attendant adverse side effects     contributes to the over-utilization of antibiotics in clinical circumstances when they are     not strictly indicated. We have learned much about the human microbiome. The emerging view is     of profound life-long bi-directional interactions between our microbiota and our cells.     Perturbations in the microbiota affect metabolic, immune, and cognitive physiology in     experimental animal models. When a person takes an antibiotic, the antibiotic diffuses via     the blood into all body compartments, selecting for resistance. We propose to examine the     effects of two commonly used antibiotics (the beta-lactam, amoxicillin and the macrolide     azithromycin) on human microbial populations and on metabolic and immune physiology, studying     healthy human volunteers in a randomized controlled clinical trial at the NIH Clinical     Center. Our hypothesis is that in addition to acutely perturbing the human microbiome, these     agents will have measurable metabolic and immunologic effects, with residual effects in the     weeks that follow. To test this hypothesis, we will assess the effects of a brief therapeutic     course of antibiotics on microbiome and metagenome composition. After an initial evaluation     period, antibiotics will be given for 7 days or 5 days (depending on the antibiotic), and     there will be a post-treatment evaluation. A control group will receive no drug intervention.     Specimens will be obtained from multiple sites at each of 10 time points occurring before,     during, and after antibiotic administration, and used for estimating bacterial and fungal     composition and gene content. We will also assess the effects of the antibiotic course on     markers of innate and adaptive immunity as well as markers of metabolic and hormonal     physiology. A subgroup of subjects will be studied in the clinical center metabolic chamber     to assess 24-hour energy expenditure and its components (sleeping, diet-induced, and activity     energy expenditure), as well as macronutrient oxidation rates (carbohydrate, fat, and     protein), during 3 of the 10 study visits. In addition to the primary data analyses, we will     build a model that integrates the temporal data to begin to understand the complex     intertwined physiology between microbiome and host.   "
44218|NCT02706912|"     Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking,     commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in a     computer-based virtual world in which stroke patients practice activities of daily living     (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE) motor     recovery and assesses system usability and user acceptance.   "
44209|NCT02707029|"     Background:      Researchers want to better understand pain by studying people with and without different     kinds of pain. To do this, researchers will expose people to pleasant and unpleasant     sensations. They will ask them questions about their pain. Researchers also want to see if     these people are eligible for other research studies at the National Center for Complementary     and Integrative Health.      Objectives:      To study the experience of pain. Also to find people eligible to join other NIH studies.      Eligibility:      People 12 years and older with and without pain disorders.      Design:      Participants will be screened by phone.      Participants will have one required visit. This may include:        -  Medical history        -  Physical exam        -  Questionnaires about themselves and their pain experience        -  Blood and urine tests        -  MRI: They will lie on a table that slides into a cylinder. They will feel different          sensations while completing tasks on a computer. This lasts 15 minutes to 2 hours.        -  Quantitative sensory testing: They will be exposed to different pictures, sounds,          tastes, and smells. They will also be exposed to pleasant and unpleasant sensations.          These could include:             -  Burning, itching, or cold sensations             -  Pinpricks             -  Pressure and pinches        -  Electrocardiogram: Stickers on the chest record heart activity.        -  Straps placed around the chest to measure breathing.        -  Small sensors on the fingers or palms to measure pulse and sweating.      Over the next 3 months, participants may have up to 4 other study visits. These last 2 to 4     hours each. They include repeats of some of the tests in the required visit.      Participants may be recorded at the visits.   "
44210|NCT02707016|"     The investigators aim to reduce the incidence of emergence delirium in children aged 2-7     years old by using two different doses of sevoflurane during inhalatory induction of     anesthesia.   "
44211|NCT02707003|"     Multi-center observational trial with study device blinded in order to assess in parallel     standard monitoring and intervention practices related to management of respiratory     compromise in the post-anaesthesia care unit (PACU)   "
44212|NCT02706990|"     The aim of this study is to evaluate the in vivo kinematics of TKA performed with two     different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica     PS) design by means of fluoroscopic analysis during activities of daily living (rising from a     chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of     femoral rollback will be analyzed to assess if they are motor-task dependent and correlated     with clinical outcomes.   "
44213|NCT02706977|"     The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel     handheld system, RETeval, and evaluate contrast sensitivity testing in detecting pre-clinical     retinopathy on a tablet device.      Investigators also seek to assess if a medication called Sinemet™ CR can improve the     electrical functions of the eye in participants with diabetes mellitus. This study will     include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic     controls. Participants with diabetes mellitus and electroretinogram (ERG) delays will be     randomized to a low or high dose Sinemet CR group.   "
44214|NCT02706964|"     Currently, once a distant breast metastasis has been diagnosed, 65% of patients will succumb     to their cancer within 2 years, and 80% will succumb by 5 years. The current National     Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer do not     recommend surveillance imaging for earlier detection of distant metastases, even for     high-risk breast cancer patients. Whereas, the standard-of-care treatment of the small     isolated (few in number) breast cancer metastases is to perform surgical resection or locally     ablative radiation therapy, however, the follow-up of breast cancer patients (including those     with a >= 30% risk of developing metastases) is to wait for clinical symptoms to appear     before using a dual positron emission tomography (PET) and diagnostic quality computed     tomography (CT) PET/CT scan, magnetic resonance imaging (MRI), computed tomography (CT) or a     bone scan to identify the site and extent of spread. Unfortunately, once metastases become     symptomatic they are often too large and/or numerous to treat with curative intent. The     current national care guidelines that advocate against intensive surveillance for distant     metastases are based on two studies performed in Italy from 1985-1993 that concluded that the     available imaging and treatment tools of the day did not prolong 5-year survival. Since then,     however, there have been major improvements in imaging and treatment technology. To be     treatable the metastases must be limited in number and limited in size, typically 6 or fewer     metastases, each of size 5 centimeter or less. This state of metastatic presentation is     called oligometastases. Numerous pilot studies have achieved dramatically improved overall     and disease-free survival when oligometastases are treated using a combined systemic plus     locally-ablative therapy of each oligometastasis. A scientific concern with the     aforementioned research studies involving ablation of isolated oligometastases, was that they     were not carried out with consistent use of surveillance imaging. Instead, these studies     effectively preselected patients for enrollment based upon having an existing oligometastatic     presentation. The primary objectives of the research study are to: (1) determine the     feasibility of the stated interventions in a multi-institutional setting; (2) document the     patterns of early metastatic spread of breast cancer; (3) document the proportion of     high-risk breast cancer patients that have an oligometastatic presentation within this     proactive imaging protocol, and (4) provide a basis to determine how to optimize future     surveillance imaging protocols with respect to the time to progression, rate of tumor growth     and organs that are affected.   "
44215|NCT02706951|"     This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX)     monotherapy in subjects with moderately to severely active rheumatoid arthritis who have had     an inadequate response to methotrexate treatment.   "
44216|NCT02706938|"     BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and     nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and     absenteeism. Head of bed elevation, as a low-cost non pharmacologic anti-reflux treatment is     nowadays recommended, but its clinical impact in patients with nocturnal symptoms remains     unknown due to inconsistent results and methodological limitations among different clinical     trials, most of which were performed before the widespread use of proton pump inhibitors in     clinical practice.      HYPOTHESIS: Head of bed elevation is a useful treatment for patients with gastroesophageal     reflux disease and nocturnal symptoms, and has a positive impact in quality of life in these     patients.      STUDY OBJECTIVE: To assess the effectiveness of head of bed elevation for treatment of     patients with gastroesophageal reflux disease and nocturnal symptoms, and to determine the     impact of this intervention in quality of life of these patients.      METHODS: Randomized single-blind single-centre controlled clinical trial with a 2x2     cross-over design. A sample of 124 patients attending to the outpatient gastroenterology unit     at Clínica Fundadores in Bogotá city, who meet the inclusion criteria and have no exclusion     criteria will be selected to participate. Included patients will be randomized to raise the     head of bed with standard 20 cm-height wooden blocks or to sleep without bed inclination     during the first 6 week period. After a 2 week washout period, allocation will be crossed and     participants will be followed again during a second 6 week period. During the trial, every     patient will receive standard pharmacological treatment with a proton pump inhibitor and/or     sodium alginate. After allocation concealment, the researchers in charge of statistical     analysis and reporting results will be blinded for the non pharmacological intervention under     study. Primary outcome is a significant symptom change according to Reflux Disease     Questionnaire (RDQ) validated form. Secondary outcomes include impact on quality of life     according to Short Form 36 (SF-36) validated questionnaire, patient preference and adverse     events of non-pharmacological intervention. Statistical analysis will be carried out with the     Statistical Package for Social Sciences (SPSS) 16.0 for Windows. Differences with a p<0,05     will be accepted as statistically significant.   "
44217|NCT02706925|"     To investigate safety, tolerability and pharmacokinetics, following single doses of BI 443651   "
44219|NCT02706899|"     This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A;     33A) and azacitidine in subjects with previously untreated International Prognostic Scoring     System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).   "
44222|NCT02706860|"     This study aims at comparing different perioperative statin regimens for the prevention of     post CABG adverse events.      This was a randomized, prospective clinical trial. Ninety four patients scheduled for     elective, isolated on- or off- pump CABG were randomly assigned to one of 3 treatment groups;     80 mg atorvastatin/day for 2 days preoperatively (N=37), 80 mg atorvastatin/day for 5-9 days     preoperatively (N=28) or 40 mg atorvastatin/day for 5-9 days preoperatively (N=29). The     corresponding preoperative doses were restarted postoperatively (post-op) when patients were     able to take the medication orally and were continued for one month. Cardiac troponin I     (TnI), Creatine Kinase (CK-MB) and C-reactive protein (CRP) were assayed preoperatively and     post-operatively at 8, 24, 48 hours, and at discharge. Marker levels were compared among the     three groups. The incidence of post-operative major adverse cardiac and cerebrovascular     events (MACCE) was assessed including; 30-day all-cause mortality, myocardial infarction,     atrial fibrillation, ventricular tachycardia/ventricular fibrillation, stroke and     target-vessel revascularization. The incidence of renal or hepatic impairment and     post-operative infections were also assessed. A Quality of life (QoL) questionnaire     (EQ-5D-3L) was administered preoperatively and 1 month after CABG.   "
44223|NCT02706847|"     The comparison of safety and efficacy of two doses of ABT-494 versus placebo in participants     with rheumatoid arthritis on a stable background conventional synthetic Disease Modifying     Anti-Rheumatic Drug (csDMARD).   "
44224|NCT02706834|"     The purpose of this study is to evaluate the safety and tolerability of single oral doses of     TAK-828 in healthy non-Japanese and Japanese participants.   "
44226|NCT02706808|"     The objective of this study is to assess whether supplementation with resistant starch from     the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product     (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both     patients under conservative treatment, such as dialysis treatment), as well as exerting a     beneficial effect with respect to reducing levels of inflammatory markers of oxidative     stress, uremic toxins and in addition, markers of cardiovascular disease.   "
44227|NCT02706795|"     This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of     daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).   "
44228|NCT02706782|"     Pancreatic carcinoma typically has a high recurrence rate and very poor prognosis. Surgery is     the best choice for the treatment of pancreatic cancer, but for those advanced pancreatic     cancer patients，when surgery is not available，chemotherapy combined with radiation therapy or     interventional therapy is commonly used in the treatment，but the prolonging survival effect     is not obvious. And now, some clinical researchers use CAR-T cells in the treatment of     pancreatic carcinoma, according to the existing results, therapeutic effects are not as good     as expecting. One of the most likely reasons is that they continued to use the intravenous     infusing of CART cells to patients, when the T cells into the blood circulation, will result     in decreased tumor activity and more potential adverse effects. We believe that a suitable     TAA targeted-CAR-T cells will be an effective way to treat cancer, as long as the pathway of     the cell infused to the body can not only improve the drug concentration of the tumor site     but reduce the potential off-target side effects. In order to achieve this goal, it is     probably the best choice to use vascular intervention to mediate CAR-T cells infusion.     Mesothelin is a cell-surface antigen implicated in tumor invasion, which is highly expressed     in pancreatic carcinoma but low-level expressed in mesothelia. We design a 2nd CART cells     targeted with mesothelin, and use vascular intervention mediated CAR-T infusion to patients.     We hope deliver anti-mesothelin CART cells locally can reducing the side effects while     enhancing the antitumor affect by more CART cells accumulate in tumor sites while less can     reach normal mesothelial tissue.   "
44229|NCT02706769|"     National guidelines advocate the use of paracetamol in conjunction with strong opioids for     cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the     analgesic benefit of paracetamol in this large patient group. The investigators aim to     establish if paracetamol in combination with strong opioids provides superior analgesia for     cancer related pain over strong opioids alone.   "
44230|NCT02706756|"     1. Purpose: 1) compare three conservative treatment approaches for subjects with          femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome          comparatively across groups.        2. Interventions will be provided based on randomized assignment. Group 1 will receive          treatment based on identified impairments and treated twice weekly to address said          impairments with hip manual therapy and exercise, as well as a prescriptive exercise for          strengthening and mobility of the hip. Group 2 will receive only the prescriptive          exercise program. Group 3 will be a control group (supervised neglect)        3. Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for          assessment of the primary outcome measure of the HAGOS. Secondary analyses will include          chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and          expectations measures), or other appropriate comparative measures. None of the proposed          treatment is considered outside of 'standard of practice'.   "
44231|NCT02706743|"     The aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the     quality of life(QOL) in differentiated thyroid cancer patients and to identify independent     factors affecting changes in the QOL.   "
44232|NCT02706730|"     This is an open-label extension study of a single intratympanic injection of OTO-104 given     every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study     104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to     be eligible for this open-label extension study.   "
44233|NCT02706717|"     The purpose of the study is to evaluate whether the probiotic Visbiome Extra Strength reduces     inflammation in HIV-infected men and women when compared to a placebo (inactive medication     like a dummy pill). The study will evaluate whether taking Visbiome Extra Strength by mouth     for 24 weeks is safe and well-tolerated for HIV-infected persons on antiretroviral therapy     (ART). Probiotics are germs such as yeast or bacteria that are found in food and supplements     that are used to improve the health of the digestive system. Many people refer to probiotics     as helpful bacteria. These bacteria live in the body and help the body work normally. In     some medical conditions, including HIV infection, helpful bacteria are replaced with bacteria     that can change the normal intestinal function and increase inflammation. The investigaors     will test whether giving a probiotic can restore normal intestinal function and decrease     inflammation.   "
44234|NCT02706704|"     The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg)     adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration,     given at zero, 2 weeks then every four weeks, in subjects with active non-infectious     intermediate-, posterior-, or pan-uveitis.   "
44235|NCT02706691|"     This phase IIa trial studies how well pan fibroblast growth factor receptor (FGFR) kinase     inhibitor BGJ398 works in treating patients with FGFR1-3 translocated, mutated, or amplified     head and neck cancer that has returned after a period of improvement. Pan FGFR kinase     inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.   "
44236|NCT02706678|"     The objective of this study is to evaluate the effects of tacrolimus sustained-release     capsules replacing cyclosporin on kidney function of renal transplant recipients.   "
44237|NCT02706665|"     The purpose of this study is the evaluation of possible relationships and correlation between     PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during     general anesthesia.   "
44246|NCT02706548|"     Many persons with chronic health conditions fail to take their medications as prescribed,     resulting in declines in health and function. Unfortunately, current interventions for     medication nonadherence are not very effective. This objective of this study is to test a new     intervention, the Integrative Medication Self-management (IMedS) intervention to improve     medication adherence in adults with chronic health conditions.   "
44238|NCT02706652|"     Background:      People's genetic markers and other genetic characteristics can affect their response to drug     therapy. Researchers want to screen people for these markers and characteristics. They want     to do this before the people are screened for studies at the National Cancer Institute. That     should save time that can be lost when people go through the whole screening for a study only     to find out they cannot join. The data collected may also be used to select the proper dose     of anticancer agents that are being studied.      Objective:      To screen people for genetic markers and/or baseline characteristics. These will be used to     determine if they can enroll in a clinical trial. They may also be used to select the proper     dose of anticancer agents that are being tested.      Eligibility:      Adults 18 and older who are being considered for or being treated in a National Cancer     Institute study      Design:      Participants will have their blood drawn for genetic tests.      Some participants will have a cheek swab.      Participants genetic data will be stored for future research. It could be shared with other     researchers....   "
44239|NCT02706639|"     Background:      DNA tells the body how to grow and function. Williams-Beuren syndrome (WS) and Supravalvular     Aortic Stenosis (SVAS) are rare diseases caused by changes in a part of a person s DNA.     Symptoms of both conditions include vascular problems including narrow blood vessels and     supravalvular aortic stenosis (SVAS) or supravalvular pulmonary stenosis. Individuals with WS     may also have developmental challenges and personality differences. Researchers at the NIH     want to find out why only some people with WS and SVAS have severe symptoms. They want to     collect samples and data to see what DNA or environmental changes affect the severity of the     disease.      Objective:      To identify the DNA differences or environmental changes that change the severity of WS and     SVAS from person to person.      Eligibility:      People ages 0 85 with either WS, SVAS, and/or an SVAS-like condition      Children and people with WS must have a parent or legal guardian to consent or help answer     questions.      Design:      Participants will be screened with questions and medical history.      Participants will have a 60-minute visit. They will provide blood or saliva samples.      They or their parent/guardian will:      Answer questions about how WS and SVAS affect them.      Sign a form releasing their medical records for the study.      If participant s regular doctor recommends surgery, researchers will ask the surgeon for skin     or tissue samples that they might otherwise discard. These will be used to create stem cells     to study in a lab.      For up to 20 years, participants will have annual questionnaires by phone, email, or mail     about their WS or SVAS.      Participants may also be contacted if:      They need to provide a new blood or saliva sample.      Researchers need any other data.      There is a follow-up study.   "
44240|NCT02706626|"     The purpose of this study is to evaluate the safety and effectiveness of this investigational     drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small     cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got     worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act     on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).   "
44241|NCT02706613|"     Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive     symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise.     Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and is     a structured programme of exercise training and education. Pulmonary Rehabilitation     encourages and enables patients to improve their exercise capacity incrementally over the     course of a six-week programme. An established evidence base has placed PR at the centre of     interventions for COPD and its provision is mandated by NICE as a key pillar of integrated     care.      Currently, the provision of PR in the NHS is limited to group sessions run over an     established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise     capacity, access to PR classes can be problematic for some patients. Also, staff and facility     resources limit delivering the programme at scale. An online PR programme developed by my     mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an     alternative provision of this important intervention.      The study aims to compare this online PR programme to conventional face-to-face PR as     currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from     Portsmouth Hospital and local Participant Identification Centres.They will then be assessed     for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake     a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as     'myPR'. Pre and post programme measurements including walking distance and quality of life     questionnaires will then be compared between each arm of the trial, to ensure that the online     PR is not inferior to the conventional face-to-face PR.   "
44412|NCT02704377|"     This pilot clinical trial studies quality of life and supportive care preferences following     radiation therapy in prostate cancer survivors. Studying quality of life and supportive care     preferences in patients undergoing radiation therapy may help identify the effects of     treatment on patients with prostate cancer.   "
44242|NCT02706600|"     There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive     Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such     as chronic cough, breathlessness and reduced tolerance to exercise. National Institute for     Health and Care Excellence (NICE) recommends that patients with COPD have a self management     plan (SMP). The utilisation of SMP's has been shown to reduce healthcare utilisation, improve     quality of life, and reduces the need for hospitalisation. Currently SMP's are delivered to     patient in a paper format, myCOPD is a web based self management system which has been     developed by Healthcare professional and patients encompasses the principles of Self     management and offers a viable solution to a national recommendation.      The study will compare paper self management plans against the online version myCOPD. The     study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital     for an exacerbation or flare up of their COPD. Patients will be given an information sheet     during their admission and prior to leaving hospital be asked if they wish to participate in     the study. Patients will participate in the study for no less than two months and a maximum     of three months. 30 patients will receive written self management and 30 will receive online     self management. There will be a total of 4 visits for the duration of the study.      The screening visits will comprise of written or verbal consent, Demographics, Medical,     exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler     technique assessment and delivery of either a written self management plan. The telephone     visits will comprise of verbal consent and completion of the COPD Assessment Test. The End of     Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and     healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler     technique.   "
44243|NCT02706587|"     The purpose of this study is to determine whether early neuromuscular electrical stimulation     is effective in the prevention of neuromuscular weakness in critical ill patients.   "
44244|NCT02706574|"     The goals of this study are to develop an objective, multi-modal classification scheme and     outcome measures for traumatic brain injury based on several measures: (1) blood-based     biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass     effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of     CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.   "
44245|NCT02706561|"     The purpose of this study is to test two different ways to help men with sexual     rehabilitation.   "
44247|NCT02706535|"     This is a Phase I, single center, two-part, randomized, open label, cross-over study. Part 1     of this study will evaluate the PK, safety, and tolerability of GSK525762 when administered     alone and when co-administered following repeat dosing of itraconazole, a known strong     inhibitor of Cytochrome P450 3A4 (CYP3A4) and a Para-glycoprotein (Pgp) inhibitor. Part 1     will consist of 2 Cohorts with preliminary PK and safety data obtained from Cohort 1     informing Cohort 2. Part 2 (one Cohort) of the study will evaluate the PK, safety, and     tolerability of GSK525762 when administered alone and when co-administered following repeat     dosing of rifampicin, a known potent inducer of CYP3A4. In vitro inhibition data indicate     CYP3A4 may be the major route of clearance for GSK525762 and co-administration of drug     therapies which modulate CYP3A4 (i.e.CYP3A4 inhibitors and inducers) is likely to alter the     exposure of GSK525762 (i.e. increase or decrease exposure, respectively). The data generated     from this current study to justify exclusion criteria on concomitant medications which affect     CYP3A4 or Pgp and also inform potential dose modification in case of co-administration with     medication affecting CYP3A4 activity. All subjects will undergo a screening visit within 28     days of the first dose of study drug followed by one treatment period and a follow-up visit     7-10 days after the last dose of GSK525762. Subjects in Part 1 will participate in the study     for up to 45 days and subjects in Part 2 will participate for up to 56 days.   "
44248|NCT02706522|"     This study is to evaluate the effects of preoperative carbohydrate intake on perioperative     neuroinflammation and development of delirium.   "
44249|NCT02706509|"     A multicenter prospective interventional comparative study that investigate pain management     during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of     oral tramadol or 'verbal anesthesia' on the patients.   "
44250|NCT02706496|"     With aging, the elderly decreased ability to control postural balance will be accompanied by     increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous     studies, it showed that the elderly over 65 years fall each year probability was 30 %, and it     increased with age (Skelton, & Todd, 2004). In view of this, age-related posture control has     become important issues of modern preventive medicine and family care.   "
44251|NCT02706483|"     Multi-center, open-label, long-term safety study   "
44252|NCT02706470|"     The purpose of this study is to determine whether Cyclosporin A (CsA) - an immunosuppressant     drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of     unexplained recurrent miscarriages, as compared with that treated with Dydrogesterone-an     active comparator. The hypothesis is based on the evidence found in vitro and in vivo     experiments that CsA can induce maternal-fetal tolerance so that it may reduce the risk of     miscarriage.   "
44253|NCT02706457|"     Barthel Index and demographic variables of patients were collected to investigate the     question whether the improvements of the functionality improves the Barthel Index over the     years.   "
44254|NCT02706444|"     To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis     graft, investigators would like to perform randomized study comparing the results of drug-     coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous     anastomotic stenosis of AVG in terms of patency.   "
44255|NCT02706431|"     Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a     limited number of studies. Although data are convincing it is of importance to evaluate this     new concept in our department before implementing it into clinical practice.      The general purpose of this project is to evaluate a new ventilation strategy during     ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on     gas exchange.   "
44256|NCT02706418|"     Once participants have been recruited, their grip strength shall be tested and they will all     complete baseline questionnaires to assess functional status and symptom severity.      Following the recruitment stage, participants will be asked to attend Medway Maritime     Hospital once a week for four weeks, to receive the massage protocol. At the first session     participants shall be asked to rate their pain (NPRS), before receiving a massage treatment.     This will be followed by instructions on how to perform self-massage, which they will be     asked to complete daily over the four-week period, and record in a diary. At the remaining     three sessions, participants shall just complete the NPRS prior to receiving the massage     treatment.      After four weeks the group will be reassessed at the same Orthopaedic Clinic they attended     prior to recruitment. They will be asked to complete a final pain score, record any changes     in their condition, repeat the initial symptom questionnaire, and finally preform a grip     strength test. The duration of four weeks was chosen as this is the time-frame within which     the specific massage protocol advises a 'significant symptom improvement' should be seen.   "
44257|NCT02706405|"     This phase Ib trial studies whether anti-cluster of differentiation (CD)19-chimeric antigen     receptor (CAR) lentiviral vector-transduced autologous T cells (JCAR014) and durvalumab are     safe in combination and can work together in treating patients with non-Hodgkin lymphoma that     has returned after a period of improvement or has not responded to previous treatment.     JCAR014 is made of patients' immune cells (T cells) that have a new gene added to them in a     laboratory, which programs them to kill lymphoma cells. Durvalumab is a type of drug called a     monoclonal antibody, targeted to PD-L1 that may help immune cells attack cancer cells more     effectively and thus help JCAR014 work better.   "
44258|NCT02706392|"     This phase I trial studies the side effects and best dose of genetically modified T-cell     therapy in treating patients with receptor tyrosine kinase-like orphan receptor 1 positive     (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic     leukemia (ALL), stage IV non-small cell lung cancer (NSCLC), or triple negative breast cancer     (TNBC) that has spread to other places in the body and usually cannot be cured or controlled     with treatment (advanced). Genetically modified therapies, such as ROR1 specific chimeric     antigen receptor (CAR) T-cells, are taken from a patient's blood, modified in the laboratory     so they specifically may kill cancer cells with a protein called ROR1 on their surfaces, and     safely given back to the patient after conventional therapy. The genetically modified     T-cells have genes added in the laboratory to make them recognize ROR1.   "
44313|NCT02705664|"     The main objective of this study is to compare subject adherence and satisfaction for two     modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL)     and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1%     (Bifonazole).   "
44259|NCT02706379|"     Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock,     which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of     patients with septic shock and improve the prognosis of patients with EGDT. However, in     recent years, the standard of EGDT to determine the existence of the target of septic shock.     Some studies have shown that there may be a manifestation of the deficiency of kidney and     liver and other organs such as kidney, liver and other organs in the recovery of EGDT.     Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when     the target is reached.The aim of this study was to investigate the effects of EGDT as a guide     to the cerebral perfusion and metabolism in order to provide clinical evidence for the     treatment of fluid resuscitation in patients with septic shock.   "
44260|NCT02706353|"     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     APX005M that can be given with pembrolizumab that can be given to patients with metastatic     melanoma.      The goal of Part 2 of this study is to learn if the combination can help to control     metastatic melanoma.      The safety of this drug combination will also be studied.   "
44261|NCT02706340|"     This is an observational study enrolling women who have had a copper intrauterine device     placed immediately after childbirth. The study follows participants for 6 month in order to     evaluate the primary outcome of IUD expulsion within 6 months of delivery.   "
44262|NCT02706327|"     The purpose of this study is to compare computer aided design/computer aided manufacturing     (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and     also to decide whether they are necessary in treatment of painful flexible flatfoot.   "
44263|NCT02706314|"     Critical illness in the ICU setting has high medical and socioeconomic importance. Critically     ill patients frequently develop severe neurologic impairment during their course of disease,     typically presenting as critical-illness-polyneuropathy (CIP), which is associated with an     increased mortality rate. To date neither strategies are available to predict nor to     specifically treat CIP.      Diagnostic tests to determine CIP during the course of critical illness are available through     nerve conduction studies. Further research is needed to find diagnostic tools to identify     patients who are on high risk to develop CIP, which could encourage the evolution of new     therapeutic strategies for CIP patients.      The aims of the study are:        1. An early detection of changes in intramural neuronal networks of human colon samples          induced by human blood serum from critically ill patients in order to predict the          development of CIP        2. The comparison of different diagnostic tests to diagnose and monitor CIP during the          course of critical illness (neurologic examination versus nerve conduction study versus          neuromyosonography)   "
44264|NCT02706301|"     Colorectal cancer survivors experience long-term negative physical and psychosocial     consequences of their disease. There is a critical need to develop novel behavioral     interventions for improving colorectal cancer survivor outcomes. The investigators have     developed a pain management intervention for colorectal cancer survivors that focuses on     addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain     and comorbid psychological distress as a concern during a clinic-based survivorship care     consult will be recruited. Participants will be randomized into either: Telephone-Based     Coping Skills Training (CST) for pain and comorbid psychological distress or standard care.     The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that     teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring)     relevant to managing pain and psychological distress. The standard care control condition     will receive resources and referrals related to managing survivorship health.   "
44265|NCT02706288|"     The purpose of this study is to understand how weight loss by a very low fat plant-based diet     with an exercise program affects metabolic and cardiovascular health in overweight adults at     high risk for disease. Outcome measures will include assessment of insulin sensitivity,     β-cell function, body fat distribution, skeletal muscle and adipose tissue biology,     cardiovascular function, cardiorespiratory fitness, muscular strength, immune function, and     the gut microbiome.   "
44266|NCT02706275|"     The purpose of this study is to determine whether externally warming critically ill afebrile     adult septic patients will improve indices of immune function and/or clinical outcomes.   "
44267|NCT02706262|"     The purpose of this research study is to 1) understand how some, but not all people with     obesity develop obesity related conditions such as type 2 diabetes and cardiovascular     disease, and 2) compare the effects of 3 popular weight loss diets (Mediterranean,     low-carbohydrate, or a very-low-fat plant-based diet) in people with obesity.   "
44270|NCT02706223|"     Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of     the population infected. At best, 25% of those infected will clear the infection     spontaneously, though for those who develop a chronic infection, they may go onto to develop     liver cirrhosis or liver cancers.      The standard of care within the NHS is that patients with a history of intravenous drug use     or those currently on methadone are at high risk of having HCV infection and should be     offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways.     Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go     onto treatment regimens that successfully clear the infection despite regular interactions     with heath care staff.      Pharmacists who have daily interactions with patients receiving methadone are ideally placed     to deliver anti HCV therapy as they have daily contact with this client group and are well     placed to advise on the drug therapy.      The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT)     for HCV treatment in patients attending Community Pharmacies in participating Health Boards     within NHS Scotland. The impact of this approach will be compared with those referred to     standard care pathways on how well participants clear their HCV infection.   "
44271|NCT02706210|"     Dementia is one of the main chronic non-communicable diseases associated with disability,     institutionalization, and mortality among elderly individuals. Alzheimer's disease (AD) and     vascular dementia (VD) are considered to be the main types of dementia. A widely shared view     is that future treatment strategies need to focus on treatment of the earliest stages of the     disease. Mild cognitive impairment (MCI) constitutes an intermediate stage between normal     aging and dementia. Vascular cognitive disorders (VCD) is an umbrella term representing a     wide spectrum of cognitive disorder evoked by or associated with vascular causes. It     encompasses patients suffering from a range of types of cognitive impairment, from mild     impairment to VD. VCD predementia (VCD-P) is at the same stage of MCI. Amnestic MCI (aMCI) is     a subtype of MCI, which is also considered to be the clinical transition stage between normal     aging and AD, and has been applied to detect the emerging dementia. In VCD, infarcts or     profuse white matter disease are considered the cause of cognitive decline. By contrast, AD     is one of the most common progressive neurodegenerative disorders thought to be caused by     amyloid aggregation and the formation of tau tangles. Both VCD-P and aMCI have a deficit in     cognitive domains, and may have the same chief complaints of memory deficit. If it can be     clear which will turn into what type of dementia in patients with cognitive impairment stage,     it can not only make us more early intervention treatment to the patients, but also can save     a lot of social resources and economic costs in clinic. By applying the resting state     functional magnetic resonance (fMRI), structural magnetic resonance imaging (sMRI) and     diffusion tensor magnetic resonance imaging (DTI) multimodal magnetic resonance (NMR)     technology, the project comprehensive analysis comparison of neurodegenerative and blood     vessels of brain function in patients with mild cognitive impairment and structural     abnormalities connection mode. This project in order to reveal the cognitive impairment     disease neural circuits in the development of the network connection and its change rule.     People can further understand the pathogenesis of cognitive impairment, discover new will     provide a scientific basis for prevention, diagnosis and treatment.   "
44272|NCT02706197|"     Tumors with low oxygen levels are associated with poor prognosis and resistance to standard     radiotherapy or systemic therapies. The ability to make repeated oxygen measurements in     tumors could be used to help select the most effective treatment or the best timing to start     therapies. The purpose of this study is to ascertain the safety and feasibility of using an     implantable oxygen sensor, known as the OxyChip, to make oxygen measurements in tumors using     EPR oximetry, a technique related to magnetic resonance imaging (MRI).   "
44273|NCT02706184|"     In patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in     combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is     planned, it shall be investigated whether E. coli Nissle suspension has an effect on duration     and intensity of chemotherapy induced diarrhea.   "
44274|NCT02706171|"     This study is evaluating treatment with CyberKnife for soft tissue sarcomas.   "
44275|NCT02706158|"     Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and     mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and     dietary status have been suggested to play a role in development of preeclampsia. Low intake     of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to     increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3     ratio and high calories consumption are possible risk factors.      Material and Methods: A prospective study will be carried out. Woman medically diagnosed as     high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary     treatment groups. In the dietary treatment group, besides medical care, all woman will get     calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter     until delivery personal extensive nutritional guidance. A 3 day food diary will be collected     at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data     during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be     documented.      In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine     will be recorded.   "
44276|NCT02706145|"     The project will utilize a quasi-experimental design to examine the effectiveness of a     community-level, three-year social norming campaign aimed at changing norms of violence among     youth 10-24, with West Louisville (WL) as the intervention community and East Nashville,     Tennessee as the control community. The project will address the following research questions     (RQs):      RQ1: To what extent is a social norming campaign effective in changing the descriptive and     injunctive norms of violence among youth in WL?      RQ2: To what extent are the descriptive and injunctive norms of violence among youth in WL     related to violent behavior (by type)?      RQ3: To what extent is a social norming campaign effective in reducing population rates of     youth violence in WL?      RQ4: Which forms of media are most effective in reaching youth of different ages with     campaign messages?      RQ5: How is community readiness related to implementation of a community-level social norming     campaign?      RQ6: How is community capacity related to implementation of a community-level social norming     campaign?      RQ7: How does community capacity to address youth violence change over time with the     implementation of a community-level social norming campaign?      RQ8: To what extent is a social norming campaign cost-effective in reducing incidents of     serious violence among youth?   "
44277|NCT02706132|"     The purpose of this study is to determine whether MSCs are safe and effective in reducing the     primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs)     morbidity in ABO-incompatible Liver Transplantation.   "
44278|NCT02706119|"     Analyze the level of metabolic control achieved with a routine of regular insulin in the     parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only     regular insulin in the PN reservoir.   "
44413|NCT02704364|"     The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in     patients with Primary Sclerosing Cholangitis.   "
44279|NCT02706106|"     It is a controlled clinical trial randomized, double-blind evaluator. Will be considered     eligible patients, individuals of both sexes, aged 40 -60, to submit at least four items of     knee osteoarthrosis classification criteria, according to the American College of     Rheumatology, pain above four points in the visual analogue scale (VAS), diagnosed with knee     osteoarthritis and who sought physical therapy treatment.      Patients will be randomized by a number sequence generated by a computer using Microsoft     Excel (Microsoft Corporation, Redmond, Washington), in opaque envelopes by researcher who     will not attend the study.Patients will be divided into two groups: group with knee patellar     hole or group without knee patellar hole. Shortly after the selection of the knee, the     patient will have his eyes blind or cover in order to keep it '' blind '' regarding the type     of knee brace that it would use.      Finally evaluator 1 will cover the knee with a black cloak, making the second evaluator     ''blind '' regarding the type of knee brace that will be used.      Two investigators will carry out the data collection. The first evaluator will collect     information on the clinical characteristics of patients, including evaluation form, numerical     pain scale, which measures the intensity of pain, test Time Up and Go (TUG) test that     measures the basic mobility of movement and test walking eight meters, whose purpose is to     measure the time that the individual takes to walk a distance of eight meters.   "
44280|NCT02706093|"     The overall objectives are to:        1. Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the          whole-body, tissue, and cellular levels.        2. Systematically compare different HIIT regimens to help identify effective doses of          HIIT that may be optimal for improving metabolic health in obese adults.        3. Assess the ability/willingness of obese subjects to adhere to a long-term HIIT program.      Findings from these studies will greatly expand knowledge about the effects of HIIT on     metabolic health, and will provide valuable information for development of programs aimed at     maximizing key metabolic benefits of exercise.   "
44281|NCT02706080|"     Antithrombotics with antiplatelet agents, vitamin K antagonist (VKA), heparin and related     substances, and new oral anticoagulants are prescribed for arterial diseases, especially in     secondary prevention of embolic disease in carrier patients of heart valves and in patients     with fibrillation atrial, and venous diseases, in prevention and treatment.      The prescription of these treatments is increasing especially in older patients associated     with many comorbidities. Today, an estimated number of 900 000 patients under anti-vitamin K     in France, and more than 1.5 million for patients on antiplatelet agents.      Venous thromboembolism (VTE) is common in the general population with an annual incidence of     10-18 cases per 10 000. The most severe form of VTE is represented by pulmonary embolism with     a third of cases. Even if a large literature allows for high grade recommendations on many     areas, there is still some gray areas regarding the long-term outcomes, the early evolution     and tolerance of treatment, including long-term recurrence, the incidence of embolic sequelae     with post-embolic pulmonary hypertension and association with other cardiovascular arterial     accident (acute Coronary Syndrome, Stroke, arterial disease of the Lower Extremities ...).      The major risk of these antithrombotic is bleeding both in terms of morbidity mortality.     Despite this risk, little study focuses on the exact epidemiology of bleeding associated with     the use of antithrombotic. If the frequency of hemorrhagic stroke is low, some populations     particularly at risk of bleeding represent the majority of serious bleeding events under VKA     or anti-platelet. However, the VKA and antiplatelet agents are the first providers of     hemorrhagic serious side effects drugs when looking at all national and international studies     on the iatrogenic with in topped gastrointestinal bleeding and intracerebral hemorrhage     (mortality of about 10 to 15%).      Moreover the recent arrival of new oral anticoagulants (Apixaban rivaroxaban, dabigatran ...)     should profoundly change the management of venous thromboembolism and cardioembolic event.     Because of their risk-benefit, simplicity and convenience of their prescription, the number     of patients treated with these new anticoagulants were to rise rapidly. In addition, many     patients deemed too fragile to be treated with VKA, should be treated with these     treatments. These new anti-Xa and anti-IIa anticoagulants already marketed or about to be.     They have the advantage over VKA: an oral way, their pharmacokinetic characteristics, absence     of biological monitoring, chemical synthesis .... If it is not possible today to give the     advantage to one or the other of these molecules, the choice will be directed by their     pharmacokinetic characteristics, their half life, their method of disposal but also by     patients co-morbidities. Although biological tests are currently available for the monitoring     of these products, therapeutic solutions for severe bleeding does not exist: there is indeed     no antidote for now, though the issue is finding a balance between increased therapeutic     benefit and bleeding risk optimization. But hemorrhagic stroke is the most serious     complications of oral anticoagulant therapy, with substantial documentation for these events     occurring under VKA but little data on those occurring with the new oral anticoagulants     (Apixaban rivaroxaban, dabigatran ...).   "
44282|NCT02706067|"     This study will evaluate the efficacy of a multifactorial approach associated with orlistat     (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination     with diet, physical activity, and/or cognitive behavioral therapy will be monitored.   "
44283|NCT02706054|"     This randomized, double-blind, placebo control, cross-over study tested the hypothesis that     periradicular injections of Meloxicam would reduce recent onset low back pain and improve     physical activity compared to saline injection at 3 months follow-up evaluation   "
44284|NCT02706041|"     Randomized study to compare outcomes of patients undergoing damage control laparotomies     versus definitive closure for which there is surgeon equipoise to randomize.   "
44285|NCT02706028|"     In this randomized, double-blind, placebo-controlled study the effects of underwater     ultrasound (US) therapy were investigated in 48 patients with moderately active rheumatoid     arthritis (disease activity score in 28 joints (DAS28) ≥3.2 and ≤5.1).      Patients randomly assigned to the ultrasound group (N=25) received underwater ultrasound     therapy to both wrists and hands for 7 minutes per session with an intensity of 0.7 W/cm2     during 10 sessions. The control group (N=23) received sham treatment under the same     conditions. At baseline, at the end of treatment (Week 2) and at the follow-up visit (Week     14), the following parameters were evaluated: disease activity - erythrocyte sedimentation     rate (ESR), C-reactive protein (CRP), tender and swollen joint counts, pain on a visual     analogue scale, and DAS28, hand function (fist making, wrist extension and flexion, hand grip     strength), quality of life - Health Assessment Questionnaire (HAQ), and the patients rated     their own condition.   "
44286|NCT02706015|"     This study evaluates the non-inferiority of Cefaliv® compared to Neosaldina® in the treatment     of migraine attack in two hundred and sixteen adults of both sexes with age between eighteen     and sixty five years old. The first Half of participants will receive Cefaliv®, the other     half will receive Neosaldina®.   "
44287|NCT02706002|"     Fluoroscopy is routinely used in trauma cases to evaluate alignment and reduction quality.     Because conventional templating has a high mismatch rate, the investigators sought to explore     whether the investigators could use intraoperative fluoroscopy while implanting the femoral     stem.   "
44289|NCT02705976|"     The aim of this study is to perform a randomized trial comparing the use of the algorithm,     with dosing of warfarin in standard manual dosage clinical practice, in a high quality     anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance     of the algorithm when used in a clinical setup. The results from the study are expected to     increase our knowledge of efficacy by using the algorithm in clinical practice.   "
44290|NCT02705963|"     The purpose of this study is to evaluate the effect of trametinib once daily on the     pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone     (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib     and its metabolite M5 will also be assessed.   "
44291|NCT02705950|"     Hypothesis:      ITB bolus can have antinociceptive effect on neuropathic pain in spinal cord injury patients,     which could depend on the subtype of pain, or on the lesion level, cervical or thoracic     spinal cord injury.      Objective:      To study the effect of intrathecal baclofen bolus on neuropathic pain in patients with spinal     cord injury at cervico-dorsal level.      Primary Endpoint:      Effect of intrathecal baclofen bolus in neuropathic pain (measured using the Neuropathic Pain     Inventory Scale, the Brief Pain Inventory and the Numerical Rating Scale) in spinal cord     injury at cervico-dorsal level.      Secondary Endpoints:        1. Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual          Analogue Scale and Penn Spasm Frequency Scale).        2. Neurophysiological examination (warm perception threshold, heat pain perception          threshold, evoked pain perception and contact heat evoked potentials).   "
44376|NCT02704845|"     The biopsychosocial model is well established in chronic low back pain (CLBP) research.     Nevertheless, researchers to date have overlooked the biopsychosocial aspects of Inflammatory     Low Back pain (ILBP). Most health care providers are biologically oriented in their treatment     of ILBP, neglecting its possible multidimensional nature. It is true that people with ILBP     may present with more complex pain and physical limitations than those with chronic     non-specific low back pain (CNSLBP), but it remains unexplored whether or not these     limitations are affected by the same pain factors that affect CNSLBP patients. This study     aims to explore and compare the biopsychosocial back pain profiles of adults with ILBP and     CNSLBP.   "
44292|NCT02705937|"     Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva     substitutes are disappointing (bad taste, poor efficiency).      The hypothesis stems from the empirical observations that many patients alleviate dry mouth     symptoms by the consumption of dairy products. Through its composition, the dairy product in     itself provides relief for the patient, due both to its physical and biochemical properties,     which could explain these observed improvements, and to elements related to the phenomena of     consumption of food as an alternative to medication. In the latter case, hedonism takes on a     role which has not been previously assessed. Initial work undertaken with the department of     applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new     milk product, to qualify and adapt a product with a health benefit in patients suffering     from xerostomia.      This dairy product has specific taste, texture and lubrication properties and will be tested     in a randomized controlled cross-over study for its efficiency and acceptability versus a     reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at     Dijon and at Besançon University Hospitals.      This way of combatting xerostomia at the interface of patients' diet, such as it is proposed     here, could help improve their quality of life, minimize harmful effects (infection, decay)     and promote adherence to treatments which are responsible for xerostomia.   "
44325|NCT02705508|"     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's     lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the     efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine     (PEG) treatment in this population.   "
44293|NCT02705924|"     Young female counselees (18-30 years) belonging to HBOC families with a known mutation on     BRCA-genes or not, receive a lot of information regarding their cancer risk. Information     sources are numerous and sometimes contradictory. Unfortunately, these women face these     issues at a key moment of there identity construction (self, relationship, sexuality) while     they are not yet concerned by health prevention measures. A special psychoeducational     intervention was designed to help these women to better cope with these difficulties.      Intervention consists in a week-end session in a thermal center (SPA) during which they will     attend short conferences given by specialists (prevention measures, prophylactic surgery,     assisted procreation, epidemiology...) and participate to role games and group sharing.      Intervention will be evaluated using self-questionnaires completed before intervention and     during the following year.   "
44294|NCT02705911|"     The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the     training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it     yields at least similar effects on BP compared to current exercise recommendations.      II. To assess whether isometric handgrip training yields larger BP reductions beyond the     supervised training period at 6 months of follow-up.      III. To determine whether changes in BP following acute exercise and chronic training can be     explained by changes in important physiological mechanisms known to mediate or to be     associated with BP?   "
44295|NCT02705898|"     Building on the large body of evidence for the effect of exercise in decreasing depressive     symptoms and the few preliminary findings of its effect on craving and drinking outcomes, the     purpose of this study is to develop a lifestyle physical activity (LPA) intervention that     harnesses the technological advantages of the Fitbit tracker (plus its web and mobile     platforms) for depressed women with alcohol use disorders (AUDs). The intervention will     provide women with an acceptable, flexible and effective alternate coping strategy during     early recovery, when relapse risk is highest. The overall objective of this work is to fully     develop this LPA+Fitbit intervention, modify it based on initial piloting and feedback to     ensure its feasibility and acceptability for depressed women with AUDs in early recovery,     propose potential mechanisms of its effect, and to obtain preliminary data on its efficacy.   "
44296|NCT02705885|"     Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a     food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas     gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8     weeks the patients were examined against. Parameters including probing depth (PD), bleeding     on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared     to the control group that had used placebo lozenges.   "
44297|NCT02705872|"     The epidural has been recognized for many years as the most effective analgesia method for     obstetrical labor. Several different administration protocols have been evaluated over the     years with the aim of reducing side effects.      Epidurals have been incriminated in the increase of instrumented births. It is indeed     possible that the motor block induced by the epidural reduces the pelvic tonus and the     ability of the mother to push during the second stage of the labor. Furthermore, this motor     block might lead to a ill rotation of the foetal head within the pelvis, which could lead to     instrumentation (suction cups, forceps).      In the investigator's institution, an ongoing study also provided interim that showed that     the use of a low concentration of local anesthetics (as opposed to a higher concentration)     tends to decrease the instrumentation and cesarean sections rate in the institution's     population.However, the optimal administration mode of the local anesthetic in the epidural     remains unknown.      In the last few years, there has been a growing interest for a new method of administration     of the solution within the epidural, by programmed intermittent bolus. This method allows a     better distribution of the local anesthetics in the epidural space, compared to a continuous     perfusion.      This study therefore focuses on the relationship between the use of epidural with programmed     intermittent boluses and the rate of instrumented deliveries and cesarean sections.      The exact mode of administration of boluses is also subject to discussion in the literature.     One can question whether it is preferable to administer smaller boluses more frequently or     larger less frequent boluses. A few studies have investigated this issue and recommend to     administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought     after physiology (ie a wider distribution in the epidural space) and provides equivalent     analgesia to smaller, more frequent boluses.   "
44298|NCT02705859|"     This study is a Phase Ib/II open label, single arm, adaptive multi-centre trial of copanlisib     in combination with trastuzumab in pretreated recurrent or metastatic HER2-positive breast     cancer.      Patients with HER2 positive, metastatic or incurable recurrent breast cancer, following     disease progression during, or after, treatment with at least one systemic treatment regimen     in the metastatic or recurrent setting, will be treated with copanlisib (at 30, 45 or 60 mg     flat dosing IV weekly - depending on the maximum tolerated dose (MTD) determined in the Phase     Ib part of the study) plus trastuzumab (4 mg/kg IV Cycle 1 Day 1 and then 2 mg/kg IV weekly     starting from day 8).   "
44414|NCT02704351|"     The purpose of this study is to retrospectively review our preliminary experience during a     surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following     CPB and cardiac surgery for repair of CHD in infants and children.   "
44415|NCT02704338|"     Separated and expanded the CD4+CD25+CD127- Tregs from peripheral blood of autoimmune     hepatitis patients and administrate the cells (5 x 106 cells/kg) into patients.   "
44299|NCT02705846|"     GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer     predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and     treatment for prostate cancer (PCa). The study includes a cohort of gene mutation carriers     with PCa matched with a control group of men with PCa who are known not to carry a mutation     in the same gene. Clinical data regarding treatment and patient outcome will be collected     retrospectively and prospectively. Archived tumour samples will also be collected for tumour     profiling. A blood or saliva sample will be taken, if the participant consents to this part     of the study, for genetic profiling to investigate any association of other inherited factors     with PCa outcomes. Information obtained from this study will be of critical importance to     support clinical trials investigating the most appropriate management of PCa in this group of     patients at increased risk of prostate cancer.   "
44300|NCT02705833|"     The primary objective of the study is to characterize the medical management of squamous cell     carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease     (between 01July2013 and 30 June 2014) in the real-world setting.   "
44301|NCT02705820|"     Single arm one stage Phase II study: post 4-6 cycles platinum doublet chemotherapy for     patients with metastatic Non Small Cell Lung Cancer (NSCLC) offering Pembrolizumab as     maintenance therapy to non-progressors with primary endpoint: Immune Related Progression Free     Survival (irPFS) at 1 year. Aim to show that this is at least 25% (compared to an expected     12% 1 year PFS based on the Pemetrexed and Erlotinib maintenance trials).   "
44326|NCT02705495|"     In this multi-centre prospective randomized controlled trial the efficacy of segmental     acupuncture in the prevention of recurrent urinary tract infections will be assessed. The     study (acupuncture) group will receive 12 acupuncture treatments according to a standardized     protocol, plus recommendation for use of cranberry products. The control group will receive     recommendation for use of cranberry products only.   "
44302|NCT02705807|"     This study is a Phase IV, open-label, single-arm study to assess the safety and the necessity     of dose adjustment after switching to FLOLAN injection prepared with the reformulated diluent     in Japanese patients with PAH who are receiving higher doses of FLOLAN injection than in     other countries. The objective is to evaluate the safety and tolerability of the thermostable     formulation of FLOLAN injection (that is [i.e.], FLOLAN injection prepared with the     reformulated diluent) when switched from the existing FLOLAN injection treatment (i.e.,     FLOLAN injection prepared with the currently marketed diluent). The study will include a     screening visit, a run-in period of a maximum of 4 weeks with the existing FLOLAN treatment     (i.e., FLOLAN injection prepared with the currently marketed diluent), a 4-week treatment     period with the thermostable formulation of FLOLAN injection (i.e., FLOLAN injection prepared     with the reformulated diluent) and a one-week follow-up visit. Adequate number of subjects     will be enrolled in the study in order to have 10 subjects to complete assessments at 4     weeks, including at least 5 subjects as a subset of subjects who consent to undergo right     heart catheterisation (RHC) over 24-hour and at Week 4. FLOLAN is a registered trademark of     the GlaxoSmithKline [GSK] group of companies.   "
44303|NCT02705794|"     The study title Clinical trial of comparative evaluation of the Modified Mallampati Score     and Modified Mallampati Score along with Thyromental distance, Anatomical abnormality, and     Cervical mobility (M-TAC) in Predicting Difficult Airway  was undertaken to evaluate     prediction of difficult airway by comparing preoperative airway evaluation tests.      Mallampati classification is the most used screening test for detection of difficult     intubation it is a classification of oropharyngeal view. Other tests include sternomental     distance, thyromental distance, Wilson risk sum score, upper lip bite test, protrusion of     mandible, tooth morphology, head extension, mouth opening, body mass index, 3-3-2 rule and     ultrasonography of neck soft tissue. We studied 200 adult ASA I & II patients of either sex,     aged between 18-60 yrs undergoing elective surgery receiving general anesthesia.      Modified mallampati classification had four grades & each grade was given a score, similarly     thyromental distance (TMD), anatomical abnormality (AA) & cervical mobility (CM) was     classified into three grades & each grade was given a score. For M-TAC individual scores were     added.   "
44304|NCT02705781|"     This study conducted in order to validate the functionality and accuracy of the smARTrack™     System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with     nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit     real-time information to an external console. The smARTrack™ feeding tube is equipped with     reflux sensors which alert when gastric contents regurgitating into the esophagus. In     addition, the smARTrack™ feeding tube is equipped with sensors designed to provide     information about the location of the tube thus assisting in reducing the incident of     misplacement during first positioning. The smARTrack™ feeding tube is also automatically and     in real-time stops feeding if the feeding tube moves out of position during ongoing use or     detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide     operator to correctly re-position the tube.   "
44305|NCT02705768|"     The present study has been planned to assess the level of serum neuron-specific enolase (NSE)     in focal seizures and its changes after antiepileptic therapy.   "
44306|NCT02705755|"     This multiple-center, 3-Cohort, single-blind dose escalation (Cohort 1), randomized,     double-blind (Cohort 2), and open-label multiple dose extension (Cohort 3C) study will be     conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the     effect of TD-9855 in improving symptoms of orthostatic intolerance.   "
44307|NCT02705742|"     In this study, investigators aimed to transplant autologous, adipose tissue derived     mesenchymal stem cells to the patients with liver cirrhosis due to HCV. We also aimed to     assess liver tissue regeneration, downgrade of clinical findings and antiviral efficacy.     Finally investigators aimed to establish an alternative treatment modality to liver     transplantation.   "
44308|NCT02705729|"     The purpose of this study is to determine whether two tooth-colored glass ionomer materials     are effective for load-bearing dental fillings.   "
44309|NCT02705716|"     This study will investigate the efficacy of an experimental dentifrice containing 0.454%     weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice     daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice.   "
44310|NCT02705703|"     This study evaluates the effectiveness of Tumor Associated Peptide Antigens (TAPA) pulsed     dendritic cell injections as a potential consolidation therapy for patients with metastatic     solid malignancies (SM). The investigators hypothesize that treatment of patients with     metastatic SM who demonstrate a tumor response, or whose disease remains stable, after     conventional first-line systemic therapy AND who lack an available, potentially curative     therapeutic intervention and whose tumor cells and/or blood express at least one (1) TAPA of     a defined panel of TAPAs will result in TAPA-specific T-cell responses without significant     toxicities. The investigators also hypothesize CD4+ and CD8+ T-cell responses generated     against specific TAPAs may translate into clinical antitumor activity.   "
44311|NCT02705690|"     This study aims to benchmark the performance of an iOS application against the Berg Balance     Scale (BBS), which is the most commonly used assessment tool by clinicians for measuring     balance across the continuum from acute care to community-based care. An iPhone will be tied     around the waist of the participant and concurrent measurements will be taken for five of the     fourteen stances which comprise the BBS.   "
44312|NCT02705677|"     The overarching purpose of this study is to advance understanding of the natural history of     Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including     CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT. Although all these     disorders are the result of specific genetic changes, there remains broad clinical variation     that is not entirely accounted for by known biological factors. Additionally, clinical     investigators currently do not have any biomarkers of disease status, clinical severity, or     responsiveness to therapeutic intervention. To address these issues, biological materials     (DNA, RNA, plasma, cell lines) will be collected from affected individuals and in some cases     from unaffected family members, initial evaluation performed to identify additional     biological factors contributing to disease severity, and these materials will be stored for     future characterization.   "
44327|NCT02705482|"     The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic     agents in adult subjects with select advanced solid tumors.   "
44315|NCT02705638|"     Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who     have persistent or recurrent disease despite standard therapies, does combination therapy     with rituximab and revlimid cause a sustained disease remission?   "
44316|NCT02705625|"     This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel,     Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with     knee osteoarthritis (OA).   "
44317|NCT02705612|"     The purpose of this phase II trial is to determine the feasibility and efficacy of     nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable     locally advanced cervical cancer.   "
44318|NCT02705599|"     To explore the stroke mechanism evolution in patients with intracranial atherosclerotic     stenosis by magnetic resonance imaging(MRI) from current first stroke to follow up stroke     recurrence. Diffusion weighted imaging was to identify basic stroke mechanism. High     resolution MRI and perfusion imaging was to monitor the dynamic changes of vulnerable     atherosclerotic plaque and hemodynamic status including antegrade flow and collateral     circulation.   "
44319|NCT02705586|"     To evaluate the feasibility of a video based mindfulness intervention for stress reduction     and to evaluate the cortisol response in persons with PD and their caregivers. The data from     this project will be used for a future grant application of a stress reduction intervention     in persons with PD.   "
44320|NCT02705573|"     In this project we want to evaluate the effect of mannitol on graft function after renal     transplantation. Due to the unclear situation regarding data of Mannitoleffect and lack of     standardization during the kidney transplant, there is an indication for performing a     randomized trial.      We are planning to perform a double-blind randomized controlled trial . In the study,     mannitol 20% with a dose of 1g / kg / KG will be compared to placebo with NaCl 0.9% in the     dose of 5 ml / kg / KG. Patients will be randomized to receive either the mannitol or NaCl.     The follow-up of the study is a week. Data will be collected, compared and published at the     end of the study. It is planned to include a total of 100 patients in the study.   "
44321|NCT02705560|"     Dietary biomarkers are compounds in biofluids that directly reflect the intake of specific     foods or food groups. Their exploration and use in the field of dietary assessments could     provide an objective measure of actual intake complementing classical assessment methods     (e.g. food frequency questionnaire, 24h recalls). To date, only a limited number of foods     have been covered by validated biomarkers.      The study is part of the international project The Food Biomarker Alliance (FOODBALL). The     study described here has been assigned to assess biomarkers of the intake of milk and cheese.     Up to now, there is an evident lack of data on specific and validated biomarkers of milk and     cheese (dairy products), which belong to the most relevant public health related foods in     Europe. This study will further provide novel insights into the influence of fermentation of     milk-based foods on metabolic effects and postprandial adaptations, which has not yet been     studied in depth before using cheese as fermented product. Outcomes will support and expand     earlier findings on correlation between the intake of fermented dairy products intake and     human health.   "
44322|NCT02705547|"     This study is an exploratory open-label clinical trial of Rosuvastatin in patients with     Friedreich ataxia (FRDA). This is an outpatient trial with the goal of enrolling 10 evaluable     adults with genetically confirmed FRDA who are between the ages of 18-65. Subjects will     receive 10mg of oral Rosuvastatin daily for three months.   "
44323|NCT02705534|"     The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with     sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if <75     kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained     viral response rate at 12 weeks.   "
44377|NCT02704832|"     Randomized trials have already demonstrated that geriatric intervention was able to improve     survival in the general elderly population but only a few have been performed in cancer     patients. At the end, these data are not sufficient to consider geriatric intervention as     validated in this setting. Case Management, coordinated by a geriatrician and a trained     nurse, could improve prognosis of elderly patients with cancer. This approach, can be     integrated in daily oncology practice. This strategy will be compared to usual oncological     management in a randomized phase III trial.   "
44324|NCT02705521|"     This randomised prospective controlled trial will investigate patients with impingement     syndrome who undergo arthroscopic subacromial decompression. The intervention group will     receive physiotherapy aided by automated sensor-based technology which will help them perform     exergames and track their rehabilitation progress. The control group will be treated by     standard physiotherapy protocols. The two groups will be compared using patient reported     outcome measures and assessment of shoulder range of movement before and after the shoulder     surgery.      Data will be collected on patient experience, engagement with the rehabilitation process and     the usability of the sensor-based technology through the use exergames. This will guide     development of methods to quantify patient activation and engagement.      Hypothesis:        1. There will be a significant clinical difference in post-surgical improvement measured by          patient reported outcomes when physiotherapy is aided by automated sensor-based          technology to perform Exergames and track progress, compared to standard physiotherapy          protocols.        2. There will be a significant difference in post-surgical improvement in range of shoulder          movement and patient improvement, measured by patient reported out-comes when          physiotherapy is aided by automated sensor-based technology to perform exergames and          track progress, compared to standard physiotherapy protocols.   "
44328|NCT02705469|"     This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in     patients with mCRPC.   "
44329|NCT02705456|"     This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that     the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a     caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy     with fixed appliances which is comparable to the caries preventive effect provided by the     regular use of a fluoridated tooth paste.   "
44330|NCT02705443|"     The purpose of this study is to further clarify existing research on the early identification     and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology     along with prior research suggests that sDTI has quantifiable amounts of heat (or lack     thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures     (temperature). These signatures will be measured and quantitatively recorded using long-wave     infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their     pathophysiological evolution. Additionally, the LWIT physiological data will be     cross-compared to the gold standard of visual assessment and other current standards of wound     evaluation.   "
44331|NCT02705430|"     The aim of the present study is: to examine some of the mechanisms by which a change in life     style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this     computerized life style regulation reduces the development of diabetic complication in a     small population based study.      (The NewMe™ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living     -www.eco-fusion.com)   "
44332|NCT02705417|"     The purpose of our study is to compare physical examination alone to color Doppler     ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of     vascular access and long-term patency.   "
44333|NCT02705404|"     The investigators are doing this research to see if they can use small tissue samples or     fluid to develop a test that will determine if the tissue samples are related or not related     to each other. The test will use the patient's DNA, which is part of their unique genetic     material that carries the instructions for the body's development and function. Cancer can     result from changes in a person's genetic material that causes cells to divide in an     uncontrolled way and, sometimes, to travel to other organs. Currently, researchers and     doctors know some of the genetic changes that can cause cancer, but they do not know all of     the genetic changes that can cause cancer.   "
44334|NCT02705391|"     We intend to investigate the clinical application of two emerging imaging modalities for     which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing     Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study     will involve multi-disciplinary contributions from nationally recognized sarcoma experts in     Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and     Pathology.      Patients will undergo additional magnetic resonance (MR) imaging at the same time as the     standard imaging.      The ability to compare several imaging modalities within a single cohort of patients     maximizes the potential of the study to impact the future management of sarcoma patients. The     collaborative nature of this study, with essential contributions from many departments will     undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the     advanced imaging experience that is acquired.   "
44335|NCT02705378|"     Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid     induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care     patients, however, is not known. Therefore, the researchers' goal is to investigate whether     naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients     already receiving prophylactic stool softeners and simulant laxatives through a double-blind,     randomized control trial.   "
44336|NCT02705365|"     To develop and implement a patient navigator (PN) program for lung screening and smoking     cessation in community health center primary care practices. This program will be evaluated     in a randomized controlled trial of primary care patients who currently smoke.   "
44349|NCT02705196|"     The purpose of this study is to see if LOAd703 (an oncolytic adenovirus) can be safely given     to patients with pancreatic cancer. The study will also evaluate whether or not intratumoral     injection of LOAd703 will support current standard of care treatment to reduce the size of     the tumor and improve survival of the patients.      Adenoviruses are known as the common cold virus and most individuals have had multiple     infections during their lifetime. Oncolytic adenoviruses are adenoviruses that are modified     so they cannot multiply and spread (known as replicating) properly in normal (e.g. healthy)     cells, but instead, they infect and replicate very well in cancer cells. This strong     replication leads to the death of the cancer cell. Oncolytic viruses have been evaluated in     multiple clinical trials for cancer treatment during the past decade and been proven safe. It     is common to have a fever the first day or two after virus injection since the immune system     will react to the virus infection. The immune system can also kill cancer cells but to do so     it needs to be properly stimulated. Oncolytic viruses alone do not seem to be strong enough     to activate clinically relevant anti-cancer responses. However, it is thought that if     additional immune system stimulators are added to the oncolytic viruses they may be able to     result in clinical relevant antic-cancer responses.      LOAd703 is an oncolytic adenovirus that has been modified to include additional immune system     stimulators. Specifically, genes that stimulate the immune system have been added to the     oncolytic adenovirus. Once the oncolytic adenovirus infects the cancer cells, the genes will     be expressed, resulting in activation of the immune response so it can attack and kill cancer     cells.      In this study, LOAd703 will be given by intratumoral injections. It will be given in addition     to standard of care treatment with gemcitabine and nab-paclitaxel. Because LOAd703 is an     experimental therapy, there will be extra visits for disease monitoring and samples     accordingly to the detailed information below. The LOAd703 is an investigational agent not     approved by the FDA.   "
44337|NCT02705352|"     Full thickness skin grafts are an essential tool in surgery around the eyelids for     reconstruction or rehabilitation following injury or surgery. Common conditions where skin     grafts are needed include cicatricial ectropion, restoration of eyelid function after tumor     removal, burns to the eyelids, or trauma. Early complications, occurring in the first 2 weeks     after surgery, are rare: wound dehiscence, necrosis, infection, bleeding, partial or complete     graft failure. However, late postoperative complications generally categorized as scarring     (including graft hypertrophy and contraction, keloid formation, and hypo/hyper pigmentation)     can limit the success and acceptability of the procedure by patients. Scars form following     any insult to the deep dermis as a result of wound healing. Factors such as age, skin type,     racial pigmentation, genetics, and sex may influence fibroblast proliferation as part of the     healing response, resulting in a suboptimal result. Graft contraction is perhaps the most     worrisome result, since it can result in failure of the initial surgery and may require     additional surgery to correct. Many treatments have been used to manage these complications:     corticosteroid injection, cryotherapy, pressure therapy, radiotherapy, laser therapy,     silicone based products, and antimetabolite therapy. One such antimetabolite, 5-fluorouracil     (5-FU), has been used over the last 15 years as an adjunct or primary treatment to modulate     wound healing and scar formation. Other studies have demonstrated safety for cutaneous and     subcutaneous injection in the periocular region. However, no controlled studies exist. This     prospective, randomized, and double-blinded clinical study will evaluate the use and benefit     of 5-FU versus saline in patients undergoing skin grafting for periocular reconstruction. The     decision for the need for skin grafting will be at the discretion of the attending surgeon     and will be made separate from enrollment in the study. Surgery will be performed as     indicated. The study medication or placebo (normal saline) will be administered 2-3 weeks     after surgery and then every 2-3 weeks afterwards for up to a total of 4 injections. After     the injections, regular scheduled follow-up will be at 3, 6, and 12 months post-op. Outcomes     at each study visit (up to 12 months post-operatively) include graft size, color, contour,     and complications between study treatment group and placebo group.   "
44338|NCT02705339|"     Though patients whose tumors harbor EGFR T790M mutation appear to benefit from rociletinib,     there is a need to understand the molecular mechanisms that lead to primary and acquired     resistance to rociletinib. The investigators propose to conduct a clinical trial of     rociletinib of patients with EGFR-mutant NSCLC with activating EGFR mutations (including exon     19 deletion or L858R mutation), with or without EGFR T790M mutation. In these patients,     pre-treatment and post-progression biopsy specimens will be subjected to genomic analysis to     fully understand the clonal evolution and the molecular mechanisms underpinning treatment     resistance.   "
44339|NCT02705326|"     The purpose of this study is to determine if feedback from a three-dimensional real-time     visualization of the tongue, a program called Opti-Speech, can be used to improve speech.   "
44351|NCT02705170|"     To establish if, in patients with new diagnosis of left ventricular dilatation without     documentation at the coronary artery angiography of significant coronary artery lesions,     there is a damage of the coronary microcirculation at the IMR (index of microcirculatory     resistance) assessment   "
44341|NCT02705300|"     Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it     has serious side effects, which may require hospitalization.      The purpose of this study is to investigate whether the addition of tocotrienol can reduce     the side effects to FOLFOXIRI otherwise leading to hospitalization.   "
44342|NCT02705287|"     The goal of this pilot project is to trace the metabolism of vitamin D in the body in     pregnant and non-pregnant women. At the conclusion of this study the investigators will have     obtained novel information on the absorption and utilization of vitamin D in women and will     have validated a new approach. The long-term goal is to better understand the unique     metabolism of vitamin D during pregnancy.   "
44343|NCT02705274|"     Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth     factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior     to those in eyes that receive standard prompt PRP therapy, however with some visual     functional benefits and less complications with Ranibizumab arm.      Applying Protocol S in real world scenario may add cost burden to the patient as patients     need about 7 injections per year which will cost the patient about 7000 US dollars a year as     minimum The primary objective of this protocol is to determine the visual acuity outcomes at     1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg     instead of Ranbizumab to lower the cost burden   "
44344|NCT02705261|"     The study is an open trial to evaluate a web-based intervention. The intervention focuses on     supporting parents to help their children to overcome problems with anxiety. The children who     are the focus of the study are in the age ranges of 4 - 12 and experience problems with     separation anxiety, social anxiety, or generalized anxiety as identified by their parents.     The program will exclude obsessive-compulsive disorder and post-traumatic stress disorder     that are seen less often in this age group and require somewhat different interventions.   "
44345|NCT02705248|"     The objective of this study is to study the association between insulin resistance and     recurrent spontaneous miscarriage (RSM).   "
44346|NCT02705235|"     Stress is an important determinant of pregnancy health behaviors, maternal physiology and     maternal-infant health outcomes. The purpose of this study is to explain the relationship     between dimensions of lifetime stress and the stress hormone cortisol in pregnant women.     Additionally, the study will examine how coping styles help pregnant women to better manage     stress and improve their health behaviors to achieve the goal of having a healthy baby.   "
44347|NCT02705222|"     The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining     an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of     treatment-specific to the cause.   "
44348|NCT02705209|"     The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since     1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal     cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as     natural medications to treat painful or aching areas in the case of acute or chronic back     pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC)     application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used     to treat musculoskeletal conditions of pain especially of the low back.      Therefore, the aim of the present study was to test effects of a series of ten applications     of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature,     skin sensory functions, pain threshold, and proprioception. Placebo control condition (0%     cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application     of a CPC will have significant effects on the measured parameters.      40 subjects will be randomized into Treatment/control group.   "
44416|NCT02704325|"     The proposed clinical trial study of rAAVrh74.MCK.GALGT2 for duchenne muscular dystrophy     (DMD) patients that will involve direct intramuscular injection to the extensor digitorum     brevis muscle (EDB).   "
44350|NCT02705183|"     Rationale: Bone metastases arise in 50% of all patients dying of cancer, increasing up to 70%     in patients with breast and prostate cancer. The lesions can cause pain and fractures,     leading to diminished quality of life and poorer survival. Current knowledge concerning     adequate, personalized treatment of metastatic lesions of the long bones in patients with     disseminated cancer is insufficient and inconclusive due to lack of large, prospective series     with patient reported outcome measures. One of the debatable issues is the effectiveness of     postoperative radiotherapy. It has become common practise due to professional opinion, but     research evidence is lacking. It is thought that adjuvant radiotherapy improves the     durability of an implant, prevents progression of the lesion, promotes bone healing, improves     limb function, minimises pain and reduces the need for reoperations, however none of these     are certain. Moreover, it is a burden on patient's quality of life (e.g. multiple extra     hospital visits) causing toxicity and possible side effects (e.g. skin irritation). The true     beneficial effect, weighing up the possible pros and certain cons, of adjuvant radiotherapy     is thus unknown.      Objective: The PORT study aims to demonstrate the non-inferiority of 'surgery only' compared     to surgery with adjuvant radiotherapy as treatment of impending and actual pathological     fractures on the pain experienced by patients.      Study design: A multicentre, prospective, randomised non-inferiority trial nested within the     OPTIMAL study.      Study population: All patients with metastases of the long bones undergoing surgery for a(n)     (impending) pathologic fracture in the participating centres.      Study intervention: One study arm (A) will receive surgery with adjuvant radiotherapy; the     other study arm (B) will receive surgery only.      Main study parameters/endpoints: Primary endpoint is patient reported pain according to a     numeric rating scale (NRS). Clinical functioning, radiological status, complications and     survival are secondary endpoints.   "
44352|NCT02705157|"     Rationale: Bone metastases arise in 50% of all patients dying from carcinoma, increasing up     to 70% in patients with breast and prostate cancer. The lesions can cause pain and fractures,     leading to diminished quality of life and poorer survival. Current knowledge concerning     adequate, personalized treatment of metastatic lesions of the long bones in patients with     disseminated cancer is insufficient and inconclusive due to lack of large, prospective series     with patient reported outcome measures.      Objective: The OPTIMAL cohort aims to describe the quality of life and pain perception of     patients after local treatment (radiotherapy and/or surgery) of metastases of the long bones,     for both the entire cohort as well as for specific treatments separately. With this a more     personalized treatment for metastases in the long bones based on expected survival and     impending fracture risk can be provided in order to improve functioning and the quality of     life for the remaining lifetime in patients with disseminated cancer.      Study design: Observational, prospective, multicentre cohort study.      Study population: All patients with metastases of the long bones visiting a radiation     oncologist or orthopaedic surgeon.      Main study parameters/endpoints: Primary endpoints are patient reported quality of life     (including functioning) and pain levels. Complications and survival are secondary endpoints.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Patients in the OPTIMAL cohort will perhaps not directly benefit from their     participation. Participation will contribute to deriving patient-specific treatment     modalities for future patients with bone metastases of the long bones. Risks associated with     participation in the prospective cohort are considered negligible due to the observational     nature of the study. The burden for the patients lies in completion of questionnaires, which     is considered to be in proportion with the potential value of this research.   "
44353|NCT02705144|"     To characterize stem cell compartments in their niches in different clinical situations     (non-diseased compared to emphysematous and fibrotic pulmonary tissue) and to assess their     proliferative and developmental properties in vitro.      To further implement lung organoid culture system in the drug screening and development of     patient personalized medicine.   "
44354|NCT02705131|"     The purpose of this study is to evaluate the therapeutic effect and safety of the Balance     Chiropractic Therapy(BCT) on Cervical Spondylotic Radiculopathy and to investigate the     mechanism of which this efficacy is achieved.   "
44355|NCT02705118|"     Fusion imaging of US and MRI is very helpful for interventional procedure such as     radiofrequency ablation in liver. However, manual registration of US and magnetic resonance     (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians.     Recently, automatic registration function was developed to help the fusion of US and CT/MRI     imaging. The purpose of this trial is to compare the registration time and accuracy of manual     registration system and automatic registration system.   "
44356|NCT02705105|"     The purpose of this study is to characterize the safety and tolerability and determine the     maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of     mogamulizumab and nivolumab in subjects with locally advanced or metastatic solid tumors.   "
44357|NCT02705092|"     The purpose of the study was to examine the immediate effect of subliminal priming with     subliminal reward stimuli on standing balance in healthy young adults. The study also     compared the outcomes with the immediate effects of subliminal priming with supraliminal     reward stimuli.   "
44358|NCT02705079|"     Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for     patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally     recommended under sedation and also carried out in practice here.      The vital signs monitoring to avoid complications is dictated by current national guidelines.     Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In     patients with severe heart disease an ECG recording should be used additionally. Moreover,     the guidelines require that the sedation is clinically monitored continuously to avoid an     unwanted anesthetic stage.      Such evaluation, however, is often difficult under clinical conditions and even     counterproductive, since a constant response and tactile stimulation of the patient (to check     clinically the depth level of sedation ), interrupts endoscopic complex intervention.     However, clinical most relevant aspect is the avoidance of unrecognized transition of     patients from the stage of deep sedation in an anesthetic stage.      Current recommendations do not take into account new study results from a gender perspective,     which showed that women and men need a different wake-up time using the EEG derivation means     by using teh Narcotrend after total intravenous anesthesia, which may be due to different     total doses of sedatives needed. However, the research group has been demonstrated in a     previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective     adaptation of sedation, in particular a more rapid recovery time by a lower dose of the     administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde     cholangiopancreatography-(ERCP).      In the presented study the investigators evaluate the extent of gender differences in the     wake-up time after sedation with propofol during endoscopic ultrasound when using EEG     monitoring.   "
44359|NCT02705066|"     The goal of this project is to determine the effects of 6-week dietary supplementation with     one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical     membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy     middle-aged adults.   "
44360|NCT02705053|"     This clinical trial is a study to assess the performance of an automated glucose control     system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes.     Specifically, the investigators will test zone model predictive control AP that will be     enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios     (CR).   "
44361|NCT02705040|"     This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.   "
44375|NCT02704858|"     NEO100-01 is a Phase 1/2A study of the monoterpene, perillyl alcohol (NEO100)in patients with     recurrent glioblastoma. NEO100 is delivered four times a day by intranasal administration     using a nebulizer and nasal mask for up to 6 months. Four escalating doses will be evaluated     for tolerability, and the maximum tolerated dose will be extended in the 2A phase for a total     of 25 patients. There is no concurrent control. This is the first nasal administration in the     US, after prior oral studies with perillyl alcohol proved ineffective. Nasal administration     of perillyl alcohol is on-going in Brazil   "
44417|NCT02704312|"     Compare dosimeters in both positions (prone and decubitus) for each patient   "
44362|NCT02705027|"     A direct application of jejunal tube feeding is necessary especially in patients with     gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease.     Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of     probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are     beneficial.      While in a randomized trial of Schwab et al. it could be shown that the use of     Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly     faster there are currently no comparative data to use the Easy-In® probe subsequently     developed , which is directly introduced through the working channel of the endoscope, and     thus shortening the procedure time.   "
44363|NCT02705014|"     To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis     in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.   "
44364|NCT02705001|"     This research project is relevant to the identification of the relationship, and its     significance, between patient morality and a number of demographic, clinical and corporate     characteristics. Two separate data sets have been compiled linking the existing intervention     and employment data, one focusing on the admitting nurse and another one considering all the     nurses involved in each intervention. Several statistical experiments will take place to     support or reject the main hypothesis: higher nurse education, satisfaction and staffing     levels result to lower patient mortality.   "
44407|NCT02704442|"     The hypothesis is that pediatric patients with increased levels of anxiety on the day of     surgery, in particular at point of anesthetic induction, will demonstrate decreased     compliance with assessment in ophthalmology clinic postoperatively.   "
44365|NCT02704988|"     Regional lymph node metastasis is a major determinant of local recurrence and overall     survival rates in patients with colorectal cancer. Because of the poor prognosis associated     with the presence of lymph node metastasis, stage III colorectal cancer patients should     receive adjuvant treatment with chemo and / or radiation therapy according to the site of     tumor. Several authors have investigated the use of revealing solutions for lymph node     clearance in colorectal cancer. Most studies comparing conventional histopathological     specimen examination to any lymph node clearing technique showed that the use of revealing     solutions increases the mean number of lymph nodes harvested, usually in a statistically     significant manner. It is still controversial the impact of the use of revealing solutions     for upstaging of lymph node status and consequently for the indication for adjuvant therapy.     Therefore will be conducted a randomized clinical trial to compares the performance of GEWF     and Carnoy solutions for the histopathological examination of patients with colorectal     cancer. The aim of this study is to determine the lymph node revealing solution with the best     performance (increase in the mean number of lymph node harvested and lymph node upstaging) in     patients with colorectal cancer.   "
44366|NCT02704975|"     The purpose of this single-blinded, randomized clinical trial is to determine the     effectiveness of dry needling compared to a standard shoulder rehabilitation program on range     of motion, functional movement, and pain in patients who have undergone shoulder     stabilization surgery. Measurements of the aforementioned dependent variables will be taken     at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It     is hypothesized that the inclusion of dry needling will result in an increase in range of     motion, increase in functional movement, and decrease in pain at an accelerated rate when     compared to rehabilitation alone.   "
44367|NCT02704962|"     The investigators hypothesis is that an antipsychotic drug combination of low-dose olanzapine     plus low-dose trifluoperazine is similar to regular-dose olanzapine monotherapy in efficacy     and safety for treatment of schizophrenia.The goal of this study is to compare the efficacy     and safety of the olanzapine (10 mg/d) and olanzapine (5 mg/d) plus trifluoperazine (5 mg/d)     in the treatment of acute psychotic exacerbations of schizophrenia.   "
44368|NCT02704949|"     One of the most effective strategies to decrease radiation exposure during ureteroscopy is to     use low dose. However, the quality of the image obtained is inferior to full dose image. The     main concern is to maintain the stone free and complication rate despite the inferior quality     of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead     of full dose would impact in a reduction of total radiation exposure despite a possible     increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone     free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone     treatment due too less than optimal fluoroscopy image. All patients over 18 years old     diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled     regarding their treatment options. Patients who failed spontaneous passage or medical     treatment or chose endourologic treatment were included in this study. Patients with abnormal     urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from     the study.   "
44369|NCT02704936|"     Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm     and seminal plasma linking the success or failure of the artificial insemination (IUI)   "
44370|NCT02704923|"     A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for     preventing Ventilator-Associated Pneumonia.   "
44371|NCT02704910|"     The objective of this study is to assess the origins of lateral postural inclination     presented by some Parkinson disease's patients.      Several mechanisms could cause lateral postural inclination. Available data allow to suggest     three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of     perception of corporal axis   "
44372|NCT02704897|"     This study aims to evaluate if a smartphone-delivered tool can help assess for wound     infections, and if this improves access to care and results in earlier treatment.     Participants will be randomised to one of two groups. The intervention group will receive the     smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about     their wound. The trial period is 30 days.   "
44373|NCT02704884|"     The aim of the present study was to determine the effects of fortified soy milk with L.     planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II     diabetic patients with nephropathy.   "
44374|NCT02704871|"     A non-interventional, prospective observational study to assess the performance of SeptiCyte®     Lab to diagnose patients identified as suspected of sepsis in general medical and surgical     wards with infection-positive from infection-negative SIRS   "
44378|NCT02704819|"     Balance is crucial for an individual's mobility and independence. Human balance is achieved     and maintained by a complex set of sensorimotor systems that include sensory input from     vision, proprioception and the vestibular system (motion, equilibrium, spatial orientation).     This information is then integrated by the brain. This complexity leads to undiagnosed or     mistreated patients with balance disorders for long period which can affect their daily     activities.      The EMBalance project is a research project funded by the European Union, involving 10     universities across Europe. Its aim is to create a Decision Support System (DSS) to support     doctors in diagnosing and treating balance disorders. It will be available to primary and     secondary care doctors of different specialties, levels of training and in different parts of     the country.      The DSS will:        -  Be used by primary and secondary health care professionals        -  Assist the doctor on the evaluation and management of dizzy patients        -  Predict how the balance disorder may progress        -  Reduce patient waiting time and the onward referrals        -  Ensure patients receive prompt and efficient treatment plans      The EMBalance randomised clinical trial (RCT) is a proof-of-concept, multicentre,     single-blind, and parallel group study, conducted in Belgium, Germany, Greece and United     Kingdom. At present, the question that this study aims to answer is whether the algorithms     developed for the EMBalance Platform will yield meaningful information and how these     algorithms and platform can be improved, performing an offline comparison of the classical     diagnostic approach and the outcome of the EMBalance platform, without any consequence for     the patient.      Patients who present with balance related symptoms at primary care will be randomised to     either intervention group (non-specialist doctor +DSS) or control group (non-specialist     doctor -DSS). An overseeing expert will then confirm the diagnosis and management decisions     made by the non-specialist doctors in order to determine whether the use of the DSS can help     them in a more precise assessment.   "
44379|NCT02704806|"     Researchers use FCM to analyze the immunol cell feature and its corresponding activation     status, as well as the thromb aspirated through the thromb aspiration device in AMI patients   "
44380|NCT02704793|"     Essential tremor (ET) is a low-mortality, though truly burdensome and debilitating condition     which is known to be the second most common movement disorder of the adult population only     after restless legs syndrome. The prevalence of the disorder in all age groups has been     estimated to be 0.9%. Repetitive transcranial magnetic stimulation (rTMS) is an almost safe     technique which has been used in diagnosis and treatment of many neurologic and psychiatric     conditions. Recent studies have shown that cerebellum has a significant role in development     of ET and that rTMS could exert therapeutic effects on its motor symptoms. In this study     researchers will recruit at least 30 subjects among patients visiting at the Specialty Clinic     of Mashhad Medical University according to researchers exclusion and inclusion criteria and     after signing a written informed consent, will randomly be assigned to either real or sham     rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz rTMS on 90% of     resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive     days and sham treatment will be performed with the same protocol using a small device placed     on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3     mili amperes), to simulate the sensation of real TMS. Subject's ear will be protected with     earplugs during both real and sham stimulations. After 2 months of follow-up, patients will     undergo crossover and receive the other treatment as described above. Patients would be     assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and 30 after     each real or sham treatment session by a blinded researcher. Data will be analysed by another     researcher who is also blind.   "
44381|NCT02704780|"     This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for     the treatment of retained placenta to reduce the need of manual removal of placenta under     general anaesthesia   "
44382|NCT02704767|"     Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant     EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add     apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.   "
44383|NCT02704754|"     Problems sleeping are common after exposure to highly threatening experiences and can occur     with and without a diagnosis of posttraumatic stress disorder (PTSD). Established treatments     for PTSD are limited for addressing insomnia and many insomnia treatments appear to be     limited in the context of PTSD. Suvorexant is FDA approved for insomnia and among approved     drugs has a unique mechanism of action that may be well suited for targetting arousal at     night dysregulated by trauma. The investigators will evaluate the efficacy of suvorexant for     insomnia that developed in relation to trauma exposure, utilizing a placebo control, and     polysomnography to identify biomarkers of response, in a six week trial.   "
44384|NCT02704741|"     The CO2RE laser system is a fractional CO2 laser that is FDA approved under a 510(k) K101321     for dermatologic procedures requiring ablation and coagulation of soft tissues, including the     skin Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina     (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol.      Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment     visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks).      Methodology described in protocol to evaluate efficacy of treatments will be carried out at     each visit at the clinic.   "
44385|NCT02704728|"     The purpose of this study is to assess the safety and tolerability of Bacteroides     thetaiotaomicron (Thetanix®)) capsules in young people aged 16 to 18 years with stable     Crohn's disease.   "
44386|NCT02704715|"     The purpose of this study is to evaluate the postoperative pain after general anesthesia of     orbital diseases and ocular tumor patients.   "
44387|NCT02704702|"     The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and     rosuvastatin when coadministered or administered alone as a single dose or as multiple doses     to healthy male subjects.   "
44388|NCT02704689|"     This is a post-market clinical study of the AccuLIF expandable TLIF cage in patients     requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or     retrolisthesis, at one or two levels, between L2 and S1.   "
44389|NCT02704676|"     The Aim of this study is to determine the relationship between serum concentrations of cancer     antigen-125 (CA-125) and pre-eclampsia severity.   "
44390|NCT02704663|"     In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups:     transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and     patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and     costs.   "
44408|NCT02704429|"     Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus     vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy,     and with conventional immunosuppressive rescue treatment, if indicated. The duration of     therapy will be 12 weeks, followed by 12 weeks of follow up.   "
44409|NCT02704416|"     This trial aims to develop evidence based curative treatment with optimal net benefit for     patients with Brugada syndrome.   "
44391|NCT02704650|"     The purpose of this study is to:        1. Identification and characterization of ovarian carcinoma well-known biomarkers,          carcinoma antigen 125 (CA125) and Human epididymis protein 4 (HE4) and other potential          biomarkers in vaginal fluids obtained from ovarian cancer patients.        2. Quantification and calibration of identified biomarkers in vaginal discharge collected          from ovarian cancer patients in comparisons to samples collected from healthy          volunteers.        3. Comparison analysis of biomarkers levels in vaginal fluids vs. serum.        4. Quantification and calibration of identified biomarkers in vaginal discharge collected          from ovarian cancer patients diagnosed in various stages.   "
44392|NCT02704637|"     HeadSense (HS)-1000 device, a proprietary non-invasive brain monitor, is expected to safely     and accurately monitor physiological signs of the brain with minimal discomfort to patients,     providing information about normal or abnormal brain-related conditions and providing     decision-making support for physicians. The investigators hypothesize that the HS-1000 is     capable of detecting vasospasm using the raw acoustic data derived from the noninvasive     procedure.   "
44393|NCT02704624|"     Thus, the aim of the current study is to assess the influence of vitamin D deficiency and,     consequently, of serum calcium deficiency in the body composition, muscular activity, bone     mineral density, fatigue, and exercise tolerance of CD patients. Secondly, it also aims to     determine the impact of vitamin D supplementation on this population.   "
44394|NCT02704611|"     The aim of this study is to assess the effectiveness of transcranial direct current     stimulation (tDCS) in treating fibromyalgia.      Participants will be randomly assigned to one of the two groups: Group I (Intervention group)     tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over     M1 bilaterally Anodal tDCS for 20 minutes at 1.5 mA (15 s ramp in and 15 s ramp out) will be     applied daily for 10 consecutive days (5 sessions/week) . The anodal electrode (24 cm² with     current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in     group I, and the reference electrode (24 cm² will be fixed over the contralateral arm     (extracephalic).      Daily tDCS was given to prolong and stabilize these long-lasting after-effects. Group II will     receive sham tDCS will be applied using the above described parameters in group I. For sham     tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real     tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However, since none     of the patients have been experienced tDCS previously, they were unaware of which stimulation     is real and which sham is. The investigator responsible for delivering tDCS had no contact     with the patients. All study participants will be followed up by the same evaluation sheet     and by an evaluator who are blinded to the type of intervention she /he has     received.Evaluation will be done pre assessment, post 5 sessions, post 10 sessions, post one     month and post 2 months by using wide spread pain index (WPI) & symptoms severity of     fibromyalgia, measuring visual analogue scale (VAS), Depression and anxiety will be assessed     using Hamilton Depression Scale (HDS) and anxiety scale, pain sensitivity threshold by using     Electronic Von Frey unit EVF4 . Determination of human beta-endorphin level before start     sessions and after end 10 sessions.   "
44395|NCT02704598|"     This is a prospective, randomized study, aiming to evaluate patients with Deep Venous     Thrombosis in lower limbs and the recanalization rates evaluated with DUPLEX ultrasound, as     so the clinical outcomes in patients submitted to oral anticoagulation with Rivaroxaban     versus Warfarin.   "
44396|NCT02704585|"     Time to stable reading of oxygen saturation at the delivery room will be compared between two     different devices.   "
44397|NCT02704572|"     The purpose of this study is to determine the optimal timing of zoster vaccination to induce     both higher cell-mediated immunity and humoral immunity in adult patients aged over 50 with     history of zoster within 5 years.   "
44398|NCT02704559|"     A randomized, open-label, oral dose, crossover study to explore drug-drug interactions     between DWC20155 and DWC20156 in healthy subjects.   "
44399|NCT02704546|"     The purpose of this study is to explore the possible effects of MPH use on physiological     functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic     and anaerobic capacity, to characterize the tendency for muscle break down while performing     monitored moderate physical effort and to assess the physiological strain while performing     moderate exercise in heat load conditions by using the heat tolerance test.   "
44400|NCT02704533|"     MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization with     PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10^5,     1.35x10^6, or 2.7x10^6 PfSPZ per dose and a total dose between 2.7x10^6 and 8.1x10^6 PfSPZ     followed by CHMI with 3,200 fully infectious PfSPZ (PfSPZ Challenge).      PfSPZ Challenge (7G8) to assess vaccine efficacy, safety, tolerability and infectivity of     ascending PfSPZ doses will be assessed in healthy, malaria-naïve volunteers.   "
44401|NCT02704520|"     This trial evaluates a novel imaging method called magnetic resonance tumour regression grade     (mrTRG) to assess how well a tumour has responded to chemoradiotherapy in patients with     rectal cancer. The TRIGGER Trial aims to evaluate mrTRG as a tool for stratifying the     management of patients according to their response to treatment.   "
44402|NCT02704507|"     A randomized, split-face, placebo-controlled, double-blind, single-center clinical trial     comparing topical retinoid on half the face and retinoid plus topical steroid on the other     half.   "
44403|NCT02704494|"     The aim of this study is to evaluate the safety and effects of resveratrol in treatment of     diabetic nephropathy.   "
44404|NCT02704481|"     The primary outcome of this study is to compare the effectiveness of a second complete course     of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following     mifepristone-misoprostol medical abortion.   "
44405|NCT02704468|"     Chronic kidney disease(CKD) patients have high incidence of coronary artery problems event     after renal transplantation. And remain a major cause of mortality. The major risk marker is     arterial stiffness. The cardio-ankle vascular index (CAVI) is a new index of overall     stiffness and can estimated the risk of atherosclerosis.      Fibroblast growth factor 21 (FGF-21) is a metabolic regulator that plays important role in     cardiac remodeling elevated FGF-21 have been reported in coronary heart disease or carotid     artery plaque and could be biomarkers for atherosclerosis disease Investigators aimed to     study the association between CAVI and FGF-21 and their relations to various parameters that     can contribute to cardiovascular disease eg. homocysteine Echocardiogram findings and other     traditional basic factors.   "
44406|NCT02704455|"     This study is a multicenter, prospective cohort study of patients diagnosed with primary     ciliary dyskinesia, the clinical information of recruited patients, including clinical     manifestations, lung function, chest imaging, quality of life and other indicators, will be     followed for 10 years.   "
44418|NCT02704299|"     Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with     Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.   "
44419|NCT02704286|"     The investigators have created an interactive knee osteoarthritis (OA) risk calculator that     estimates a user's risk of developing symptomatic knee OA as well as the user's risk for     undergoing a total knee replacement (TKR) within their lifetime. To test the impact of the     calculator, the investigators recruited OA-free subjects from Amazon's Mechanical Turk.     Participants were randomized to either access general information about OA or use the risk     calculator in addition to accessing general OA information. The investigators hypothesized     that participants randomized to the risk calculator arm would have more accurate perception     of their knee OA risk and would have increased willingness to change risky behavior compared     to the general OA information group.   "
44420|NCT02704273|"     This is a pre-Phase 1 prospective, non interventional clinical assessment study to evaluate     XLMTM subjects aged 3 years and younger. Many of these clinically relevant measures have not     yet been routinely assessed in this population and may provide important insight on the     natural history of XLMTM and for future evaluation of potential therapies.   "
44421|NCT02704260|"     search for a genetic cause of vascular endofibrose   "
44422|NCT02704247|"     The aim of this porject is to test the Cardiospace system that integrates several medical     devices to monitor the cardiovascular system:        -  ECG        -  Brachial blood pressure        -  Continuous finger blood pressure        -  Ultrasound        -  Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the          cardiovascular system of astronauts for research purpuse.   "
44423|NCT02704234|"     Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their     genitals between the vagina and labia (lips of the vagina). They also have pain when they     have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain,     that they cannot have sex.      This research is being done for two reasons. The first reason is to test a set of special     needles called double-blinded acupuncture needles to give acupuncture treatments (one is a     real needle and the other is a fake needle). The second reason is to develop a protocol     (checklist) that will be used in this and future studies, and to identify and resolve any     procedural problems. The protocol will be first tested by the principal investigator who is     also an acupuncturist. The investigator will perform acupuncture using the protocol, if     necessary change the protocol, and then teach a second acupuncturist using the modified     protocol how to use the double-blinded acupuncture needles.      The real needle called the penetrating needle penetrates the skin. The fake needle called the     non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so     it feels like a needle is being inserted. It has a blunt tip.      Participants can't see which needle they are getting acupuncture with because the needles are     housed in a double-blinded needle device which has two tubes (an inner and an outer) that     neither the acupuncturists nor the participants can see through.      If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used     for drug studies to see how well the real medicine works, the investigators can see how     effective acupuncture is. The investigators will be testing these needles to treat     participants with vulvodynia.   "
44424|NCT02704221|"     This study is a feasibility trial, testing the hypothesis that among sedentary mothers of     behaviorally at-risk preschool-aged children, those who receive behavioral parent training     (BPT) programs and concurrently increase their physical activity levels will demonstrate     improved parenting and child behavior outcomes compared to those who receive BPT but remain     sedentary.   "
44425|NCT02704208|"     The Thrive With Me (TWM) trial is testing the efficacy of a mobile enhanced website aimed     at improving Antiretroviral Therapy (ART) adherence for HIV-positive men who have sex with     men (MSM). TWM is a technology-delivered peer-to-peer social support intervention with social     networking and gaming components. In addition to real-time peer-to-peer support capabilities,     the TWM intervention provides participants with Antiretroviral Therapy (ART) adherence     self-monitoring tools, medication dose reminders, and HIV-related informational content.   "
44426|NCT02704195|"     Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on     freezing of gait in Parkinson's disease   "
44427|NCT02704182|"     The objective of this study is to detect the effect of trans-cranial direct current     stimulation on postoperative pain and opioid consumption in total knee arthro-plasty     patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4     sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given     on 4 consecutive postoperative days, group 1 will receive real stimulation with the active     electrode over the leg representation of the motor strip (cortical motor area of the leg) and     the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be     evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line)     after 1st, 2nd, 3rd and 4th sessions.   "
44428|NCT02704169|"     The last decade has seen progressive advances in RT delivery, such as intensity modulated     radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly     precise radiation dose delivery. Together, IMRT and IGRT offer the potential of more     selective treatment of the primary tumour and surrounding neck nodes by reducing the dose     inflicted on critical organs at risk without compromising tumour dose and. IMRT has been     shown to significantly decrease radiation-induced toxicity, and is now considered standard     treatment for H&N tumors. With these advances in delivery technology, the accurate definition     of the target is emerging as the weakest link in the radiotherapeutic treatment chain.     Accurate target definition is the primary link on which all subsequent treatment planning and     delivery depend and is therefore critical for successful RT. Incorrect target definition can     result in poorer outcomes through either less tumour control, more normal tissue toxicity, or     both. Computed x-ray tomography (CT) is the standard volumetric imaging modality for RT     because of its high resolution, accurate definition of anatomy and its intrinsic measure of     electron density necessary for accurate dose calculation. However, its ability to distinguish     between tumour and normal tissue is limited due to a lack of contrast for structures of     similar electron density and image artifacts for objects of high density. This additional     noise can result in large inter-observation variability. Disease visible on endoscopy can be     contoured and registered to the planning CT, allowing inclusion of superficial disease     invisible on the volumetric CT image dataset into the treatment plan.   "
44429|NCT02704156|"     The safety and efficacy of five-fraction stereotactic body radiation therapy treating locally     advanced pancreatic cancer   "
44431|NCT02704130|"     This single-center, prospective randomized controlled trial (RCT) is designed to compare the     outcomes and clinicopathologic results of trans arterial embolization (TAE) and microwave     ablation (MWA) combination therapy with MWA monotherapy for the treatment of early (stages 0     and A) hepatocellular carcinoma (HCC). The primary aim of this study is to test the following     hypothesis: 2-year intrahepatic disease-free survival does not differ between patients     receiving the experimental therapy (MWA + TAE) and patients receiving the standard therapy     (MWA alone) as treatment for early stage HCC. Secondary aims are: 1) to determine the     clinical feasibility of TAE + MWA in HCC patients with a small tumor burden using patient     demographics and disease characteristic data and 2) to determine the effect of TAE on     radiographic tumor characteristics in this patient cohort.   "
44432|NCT02704117|"     The purpose of this study is to test the effects of non-invasive neuromodulation,     transcranial direct current stimulation (tDCS), on brain function in individuals with     obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain     stimulation might change the functioning of regions implicated in OCD, and thereby inform     possible future therapeutic uses.   "
44433|NCT02704104|"     This study is designed to monitor patient safety after excision of skin lesions and     subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5     for controlling bleeding in skin wounds.   "
44434|NCT02704091|"     The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo     regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in     adult subjects.   "
44435|NCT02704078|"     Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly     established modality for diagnostic evaluation of mediastinal lesions. The procedure is     routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New     Delhi since 2012. Transesophageal approach for fine needle aspiration of mediastinal lesions     using the Endobronchial Ultrasound (EBUS) scope [also described as Transesophageal     Bronchoscopic Ultrasound Guided Fine Needle aspiration (EUS-B-FNA)] (also routinely performed     in the department) and has been described as a safe and efficacious modality. EUS-B-FNA is     usually employed when EBUS-TBNA is not feasible or excessive cough or secretions necessitate     switch to esophageal route. We hypothesize that EUS-B-FNA as the primary approach has similar     diagnostic performance as EBUS-TBNA and is associated with greater patient and operator rated     procedure comfort and lesser requirement of anaesthesia medications for evaluation of     patients with mediastinal lesions easily accessible with either of the two approaches.      We propose to undertake a prospective randomized comparison of Transesophageal (EUS-B-FNA)     versus Transtracheal (EBUS-TBNA) approach for fine needle aspiration using the same EBUS     scope in patients referred for endo-sonographic evaluation of mediastinal lesions. A total of     100 serial patients (with Subcarinal and/or Lower Left paratracheal located mediastinal     lymphadenopathy at least >1cm in Short axis diameter) shall be included. After consent and     preliminary investigations, patients shall be randomized equally into the two approaches.     Procedure will be performed under local anaesthesia (topical lignocaine) and i.v. sedation     (midazolam and fentanyl) in the bronchoscopy laboratory. The primary objective will be     comparison of proportion of diagnostic and adequate aspirates in the two groups. Secondary     objectives will include operator rated cough (VAS), Operator rated overall procedure     satisfaction (VAS), dose of midazolam and fentanyl administered, lignocaine dose and total     procedure duration.The primary data analysis shall be for the performance characteristics of     the primary approach. All the aspirates shall be analysed by the same pathologist for final     interpretation.   "
44436|NCT02704065|"     End-stage renal disease related to AA amyloidosis is well characterized but there is limited     data concerning patient and graft outcomes after renal transplantation. The aim of this study     is to evaluate the clinical features of, and risk factors for recurrent AA amyloidosis, as     well as the effects of these factors on the ultimate outcome of renal allografts.   "
44610|NCT02701803|"     In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and     continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by     using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device.     In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing     it with written patient diaries.   "
44437|NCT02704052|"     Venous thromboembolism (VTE) encompasses deep venous thrombosis and pulmonary embolus, and is     the proximate cause of death in over 100,000 hospitalized patients per year. To put this in     better context, VTE kills more people each year than the annual morbidity from motor vehicle     crashes and breast cancer combined. Surgeons commonly provide enoxaparin, a low molecular     weight heparin, for VTE prophylaxis. Enoxaparin's activity is quantified by anti-Factor Xa     (aFXa) levels. Studies of enoxaparin metabolism in patients with traumatic injury, thermal     injury, or those undergoing reconstructive surgery have shown that standard dosing can result     in inadequate aFXa levels, likely from the hypermetabolic state associated with significant     injury. Small studies have associated subtherapeutic aFXa levels with increased risk for life     or limb-threatening VTE events. Prior work from has shown that 2-10% of highest risk surgical     patients have a VTE event despite enoxaparin prophylaxis. The investigators believe that     surgical patients would benefit from an individualized dosing regimen for enoxaparin     prophylaxis and that individualized dosing will decrease observed rates of life or     limb-threatening post-operative VTE events.      This project will critically examine the pharmacokinetics of prophylactic doses of enoxaparin     in surgical patients, and will evaluate how alteration of enoxaparin dose magnitude and     frequency affects peak and trough aFXa levels as well as risk for re-operative hematoma. If     subtherapeutic aFXa levels are observed, the study will design, implement and test a clinical     protocol to optimize post-operative aFXa levels. Although not an explicit Aim, this study     will also provide important preliminary data on VTE rates in surgical patients with in range     and out of range aFXa levels.   "
44438|NCT02704039|"     The goal of this research program is to develop a simple, noninvasive diagnostic device for     assessing skin pathology without the need for a biopsy. The device being studied is a single     system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and     laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this     objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy     of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250     patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for     diagnosing skin malignancy.   "
44439|NCT02704026|"     Malnutrition and growth retardation are common in children with inflammatory bowel disease     (IBD), especially in Crohn's Disease (CD). Malnutrition is associated with disease type,     anatomical location, severity of disease and age of patient. Recently, it is reported that     almost all children with CD and half with Ulcerative Colitis (UC) have reduced lean mass,     however, body fat alteration are not well defined.      The aim of this prospective and observational study was to evaluate nutritional and growth     status and body composition of children with IBD using anthropometric measurement and     bioelectrical impedance during 1 year follow-up.   "
44440|NCT02704013|"     It is a single-center, prospective, interventional, single-arm study. Aim is to investigate     which variables are significantly correlated with prolonged anticholinergic treatment (>6     months) in children with overactive bladder (OAB). Investigated variables will include     urinary neurotrophins and inflammatory cytokines, sonographic biomarkers, symptom score     scale, demographics, and urodynamic findings. Secondary aim is to analyze sensitivity and     specificity of urinary biomarkers in diagnosis and management of OAB compared to urodynamics     and treatment outcome.   "
44441|NCT02704000|"     This study evaluates the efficacy and cost-effectiveness of two platforms for delivering home     visiting programs in the poor urban setting of Sao Paulo's western region: a program     delivered by a newly trained cadre of Child Development Agents, and a program delivered by     Community Health Agents employed by the government as part of the Family Health Strategy     (ESF). The program will randomly select 400 mother-child dyads to follow a curriculum that is     currently being adapted to the local context. The primary outcome of the program will be     cognitive development for children aged 9 to 15 months old at baseline (21-27 months at     endline) The secondary outcomes will include child physical development as well as maternal     mental health.   "
44442|NCT02703987|"     The purpose of this study is to investigate the effect of a fermented infant formula on     lactose digestion in lactose intolerant adults.   "
44443|NCT02703974|"     The study will collect and analyze quantitative data regarding handwashing behaviors among     school-aged children to determine the impact of nudges compared to handwashing and hygiene     education programs.      Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates     of handwashing than traditional handwashing and hygiene education programs.   "
44444|NCT02703961|"     The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The     3 year disease free survival was about 50-70%. The distant metastasis is the main cause of     failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy     (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to     investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin     and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease     free survival would be increased by 10% with this new treatment schedule.   "
44445|NCT02703948|"     This is a multi-center, open-label, single-arm study to assess the safety of an injection     technique with Restylane Silk in lip augmentation and correction of perioral rhytids .   "
44446|NCT02703935|"     Background: Cancer-related fatigue is the most common concern reported by Childhood cancer     survivors. Empirical evidence is needed to find out an appropriate strategy for ameliorating     its impact.      Purposes: To examine the effectiveness of an adventure-based training programme in promoting     regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong     Chinese childhood cancer survivors.      Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated     post-test, between subjects design has been conducted. Recruitment of subjects has been     carried out in an outpatient clinic, and through the Children's Cancer Foundation and     Sunshine Group, which are non-profit voluntary organizations with the aim to provide     education and supportive services to parents of Hong Kong Chinese childhood cancer survivors.      Intervention: Participants in the experimental group have joined a four-day adventure-based     training programme, which contains education talks, a workshop and adventure-based training     activities. Those in the placebo control group has received an amount of time and attention     (leisure activities organized by a community centre) that mimick that received by the     experimental group.   "
44448|NCT02703909|"     Obesity affects more than 78 million adults in the United States and it is estimated that 35%     of the US population is obese. Currently, more than 179,000 bariatric procedures are     performed in the US each year with the majority of these surgeries using laparoscopic     techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but     there is no evidence that a deep NMB improves surgical conditions and that the surgeons can     discriminate between a moderate and deep NMB. There is also evidence that maintaining low     insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal     of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis     that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in     the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize     lower insufflation pressure and decreases postoperative pain requirements after laparoscopic     bariatric surgery.   "
44449|NCT02703896|"     Effect of orally administered two equal and consecutive doses of proton pump inhibitors,     omeprazole, lansoprazole, esomeprazole , rabeprazole and pantoprazole and Histamine 2     receptor antagonists cimetidine, ranitidine,famotidine,nizatidine and lafutidine without and     with a prokinetic agents domperidone, metoclopramide and erythromycin on intragastric pH,     volume and bile refluxate.   "
44450|NCT02703883|"     The purpose of this study was to evaluate the effectiveness of body weight-supported     treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord     injury (SCI) in chronic stage   "
44451|NCT02703870|"     The purpose of this Study is to determine whether non-invasive transcranial direct current     stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual     Cortex.   "
44452|NCT02703857|"     The surgical site infection is one of the most important causes of postoperative morbidity.     The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical     site infections. The recommendations of the French Society of Anesthesia Resuscitation on     antibiotic prophylaxis in long surgeries are based on low documentation, including frequency     and dosage of reinjection.      The main objective of the study is to describe the tissue and plasma pharmacokinetics of     cefoxitin after repeated injections.      This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of     major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic     prophylaxis by cefoxitin.      They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then     every 2 hours until closing.      The primary endpoints are:        -  Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after          start of each infusion cefoxitin        -  Tissue free concentrations of cefoxitin every 20 minutes after the start of the first          infusion cefoxitin until skin closure        -  Urinary concentrations of cefoxitin   "
44454|NCT02703831|"     Two recent studies showed that having two attending spine surgeons performing complex adult     spine deformity surgery instead of one, decreased complications, unplanned surgeries within     30-days [Ames], 90-day readmissions, wound infection, pulmonary embolism/deep vein thrombosis     and post-operative neurologic complications [Sethi]. However, both studies were retrospective     and did not evaluate any cost-savings associated with having two spine surgeons instead of     one performing complex spine deformity surgery.      Most cost-effectiveness studies have used traditional accounting (TA) methods to determine     costs. A few cost-effectiveness studies have used time-driven activity-based costing (TDABC)     [Kaplan] in medicine [Au, Balakrishnan] and none in spine surgery.      Objectives: The objectives of the study are (1) to determine if dual spine attendings reduce     downstream costs compared to a single spine attending for complex spine surgeries using     traditional accounting methods; and (2) to demonstrate an application of the TDABC method to     evaluate the operating room phase during complex adult spinal deformity surgery and compare     it to traditional accounting methods (TA).   "
44455|NCT02703818|"     This is a prospective, multi-center post-market study of the Senza System in subjects with     chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared     to Baseline data collected at the beginning of the study.   "
44456|NCT02703805|"     Building on an earlier pilot study, this randomized controlled trial will compare the     effectiveness of a 12 week community YMCA-based wellness program specifically designed for     people with stroke (Fit for Function) to a standard YMCA membership.   "
44457|NCT02703792|"     This qualitative study uses focus group methodology and purposive sampling with the aim of     obtaining views of Care Home Support Service staff and other stakeholders about their     experiences of a redesigned National Health Service (NHS) Care Home Support Service.     Individual stakeholder focus groups will be conducted with General Practitioners (GP), care     home staff, relatives of residents in care homes, service-user representatives (Total N=32,     across 4 focus groups). This study forms part of a larger evaluation of the CHSS service;     service improvement workshops will be conducted with Oxford Health NHS Care Home Support     Service, Community Nursing and Community Mental Health staff that are working in the 102     participating homes. Each participant who consents will take part in a focus group to explore     their experiences of a redesigned NHS care home support service. Participants will be     involved in the study for up to six months from gaining informed consent until last contact     with the research team when a summary of the research will be sent. The data will be analysed     using thematic analysis and applied with the Reach, Effectiveness, Adoption, Implementation     and Maintenance (RE-AIM) framework.   "
44458|NCT02703779|"     Explore stem cell collection with or without bortezomib with in-vivo purging in multiple     myeloma.   "
44470|NCT02703623|"     The goal of this clinical research study is to find out if the combination of apalutamide     (also known as ARN-509 or JNJ-5602192), abiraterone acetate, and prednisone can be given with     either ipilimumab or cabazitaxel plus carboplatin to control metastatic CRPC. The safety and     effectiveness of these drug combinations and their effect on the immune system will also be     studied.   "
44471|NCT02703610|"     The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of     the comparative efficacy of 4 oral analgesics in the the management of acute musculoskeletal     extremity pain in elderly patients who present and then are discharged from the ED.   "
44459|NCT02703766|"     This study aims to examine the role of weight gain in adipose tissue immune cell influx and     development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic     systemic inflammation is implicated in the development of cardiometabolic disorders in     obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating     obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease.     Proinflammatory cytokines contribute to the initial influx of immune cells into adipose     tissue during weight gain. However, mechanisms regulating these cytokines in the adipose     tissue milieu and the effects of weight gain on adipose tissue are not completely understood.      The study proposes to investigate the molecular events contributing to increased infiltration     of macrophages and T-cells into adipose tissue during weight gain. The central hypothesis is     that in lean subjects (with low body fat mass), healthy fat gain which is associated with     decreased expression of proinflammatory cytokines. However, in obesity (high body fat mass),     adipose tissue is altered, which permits increased expression of inflammatory cytokines and     further fat gain results in influx of immune cells. To test the hypothesis, adipose tissue     from well characterized lean (control, with low body fat) and obese individuals (with high     body fat) at baseline and after a modest 5% weight gain will be used. Adipose tissue samples     after subsequent weight loss will also be examined.      For this study, obesity will be defined by body composition rather than body mass index     (BMI), as several studies have shown that BMI does not adequately define obesity and several     individuals with normal BMI may indeed have high body fat mass. Individuals with body fat     content ≤25% for men, & <35% for women) will be considered lean and individuals with body fat     content >25% for men, ≥35% for women will be considered obese.   "
44460|NCT02703753|"     This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish     who have a high risk on perinatal morbidity because of overweight or obesity. Half of the     patients will receive the lifestyle intervention while the other half will receive usual     care. It is hypothesized that an effective lifestyle intervention directed towards healthy     living, including reduction of overweight or obesity and, if applicable, smoking reduction,     health problems in mothers and their offspring can be prevented.   "
44461|NCT02703740|"     This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in     the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF     (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).   "
44462|NCT02703727|"     Oral anticoagulation therapy (OAC) entails a high potential for adverse events and strict     adherence is needed.Thus, medication review and identification of safety issues and knowledge     gaps about OAC is critically important. The polymedication check (PMC) is a reimbursed     intermediate medication review focusing on adherence and medication management for Swiss     primary care. Investigators aime to assess the impact of the PMC extended with a     semi-structured interview focusing on OAC.   "
44463|NCT02703714|"     This is an open label phase II trial to examine efficacy and safety of a novel combination of     pembrolizumab plus induction GM-CSF in patients with advanced biliary cancers treated at     UCSF.      This phase II study will examine the efficacy and safety of the novel combination of     pembrolizumab plus induction GM-CSF in advanced biliary cancer patients with the hypotheses     that the combination may increase proportion of patients with PFS6 compared to contemporary     historical controls, with acceptable safety.   "
44553|NCT02702544|"     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume,     Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance     cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau)     while lifting the leg at different angles. The measurement lasted 12 minutes.   "
44464|NCT02703701|"     The United States spends over $8,000 per capita annually on health care and its health care     system is more expensive than other developed countries. Even with high per capita costs and     a high proportion of physician specialists, the US lags in health care performance from     patients' perspectives.      The hospital emergency department (ED) is often the portal of entry for patients seeking     health care services and is therefore an ideal setting for initiatives to improve efficiency     of care delivery and patient satisfaction. Reduction in wait times, enhanced information     delivery and ED staff service quality all have a positive influence on patient perception of     health care quality and satisfaction.      Prior studies have attempted to increase patient satisfaction by improving staff     communication and courtesy, implementing a patient satisfaction team in triage, and     delivering information to patients in a timely manner. Another strategy to increase the     efficiency of ED operations is adding a physician to triage to perform brief medical     screenings and initiate necessary patient testing and treatment. This contrasts to usual     practice in which physicians evaluate patients only following registration and nurse     assessment of illness or injury severity.   "
44465|NCT02703688|"     Few treatments have been developed for young children with obesity from diverse backgrounds.     The present study will develop and test an intervention designed to improve preschool obesity     in Latino children. The intervention will focus on improving eating, activity, and sleep     behaviors and the home environment for improved weight status.   "
44466|NCT02703675|"     Research has shown that lowering brain temperature may have good results in heart attack     patients. Lowering brain temperature may be a promising treatment for stroke patients. The     Excel Cryo Cooling device drops brain temperature by cooling the blood in arteries in the     neck. The device is a neck collar with a cooling pack which when shaken can reach low     temperature within seconds. The collar is placed around the patient's neck and the cooling     pack is applied to the front of the neck and held in place. This device provides stable     cooling irrespective of participant size or weight. The objective of this study is to test     the value of using Excel Cryo Cooling device in dropping brain temperature in 3 different     groups of adult participants:      i. Healthy adult volunteers, ii. Adult participants with normal body temperature in intensive     care unit iii. Adult participants with fever in intensive care unit   "
44467|NCT02703662|"     To date, there have been no prospective randomized controlled trials that compare various     biologic mesh materials in the context of abdominal wall reconstruction. As a result, this     proposal describes a 'head to head' randomized controlled trial (RCT) between 2 of the     market's most popular biologic meshes. Strattice (noncross-linked porcine dermis, LifeCell     Inc.) will be compared to Permacol (cross-linked porcine dermis, Covidien Inc.) in a     randomized manner. Although there are significant differences between these mesh products     with regard to procurement, tissue processing and cost, clinical controlled trials are needed     to compare their performance.   "
44468|NCT02703649|"     Letrozole is considered an established treatment for ovulation induction.The most common     protocol is daily dose of 2.5-7.5 mg starting day 3-5 of the cycle for 5 days.Another     described protocol is single high dose 20mg Letrozole given on day 3 of the cycle.      Our aim is to compare the single high dose Letrozole protocol to daily low dose protocol.   "
44469|NCT02703636|"     To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function     measured as change from baseline to week 24 in the total score of Mini-Mental State     Examination (MMSE) in mild to moderate Alzheimer's disease (AD) patients who failed to     benefit from other cholinesterase inhibitors (ChEIs).   "
44472|NCT02703597|"     Objectives:      Objective 1: Conduct focus group discussions with 15 adolescents in order to design     game-based social activities (GSA's) aiming to reduce smoking curiosity and increase positive     connections.      Objective 2: Through a short-term pilot evaluation, compare the use of a smoking prevention     interactive experience (ASPIRE) alone (ASPIRE group) with the use of GSAs along with ASPIRE     (GSA-ASPIRE group).      Hypothesis 2.1: Adolescents in the GSA-ASPIRE group will be more likely to decrease in their     intention to smoke, when compared with adolescents in the ASPIRE group.      Hypothesis 2.2: Adolescents in the GSA-ASPIRE group will be more likely to (a) reduce in     smoking curiosity and (b) engage in positive social influence, when compared with adolescents     in the ASPIRE group.      Exploratory hypothesis 2.3: (a) Smoking curiosity and (b) Positive social influence are     related to the decrease in intention to smoke.      Objective 3: Conduct in-depth interviews with 15 adolescents in order to obtain feedback on     how GSAs can be best improved as part of future research.   "
44473|NCT02703584|"     All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual     trigger are all retrospective. The investigators therefore aim to perform a prospective     randomized controlled study in normal responders, comparing cycles triggered with hCG to     those triggered with hCG+GnRH agonist.   "
44474|NCT02703571|"     Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose     expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer.     Open-label, nonrandomized.   "
44475|NCT02703558|"     This study is a prospective randomized controlled study. Female patients over 18 years of     age, who present for treatment of pelvic organ prolapse and/or stress urinary incontinence at     the Pelvic Floor Center at the Johns Hopkins Bayview Medical Center, and who consent to     undergo a urogynecologic surgical procedure, will be considered for inclusion in the study.     Their histories will be reviewed by their attending surgeon and if they meet inclusion and     exclusion criteria, they will be recruited for participation. The primary investigator and     co-investigators (attending physician, fellows) will determine patient eligibility. Regarding     privacy issues, the patients will be consented for both the procedure and for the study with     careful attention made to emphasize patient confidentiality. When the patient presents for     surgery, they will be randomized to receive either preoperative pyridium or intraoperative     fluorescein or no dye. Given the color differences between the dyes, blinding will not occur.     The process for recruitment will be consistent and any deviations from the protocol will be     reported to the Johns Hopkins Internal Review Board.   "
44572|NCT02702297|"     The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as     well as computerized fetal ECG analysis are suitable clinical parameters to detect an     imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome     (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined     on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.   "
44476|NCT02703545|"     Various centers around the world are currently investigating the feasibility and yield of     surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to     accumulate that surveillance may lead to the early detection of non-invasive precursor     lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to     reduce mortality in these high risk individuals, but before this can be confirmed many     research questions need to be answered. While the numbers of high-risk individuals screened     in each separate screening facility are likely too small to properly address many of these     questions, pooling data comprises a sizable sample size providing unique research     opportunities. The objective of this study is retrospectively review all cases of high-risk     individuals participating in our pancreatic surveillance program in whom 1) a suspicious     precursor lesions was detected for which a pancreatic resection was performed and 2) in whom     an advanced malignant disease was diagnosed. The de-identified information will be entered     into an international multicenter database registry.   "
44477|NCT02703532|"     The objective of this study is to identify the potential benefits of a home-based,     intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation.     Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive     constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized     to traditional caregiver education or a web based intervention for the duration of stroke     survivor therapy. By learning the best way to involve family members in therapy,     investigators hope to decrease the harmful effects of stroke.   "
44478|NCT02703519|"     This prospective, controlled, clinical, intervention study measures the number of uterine     Cesarean section scars and median myometrial thickness of women who underwent two Cesarean     sections six to nine months after their last Cesarean section using transvaginal ultrasound.      It is the purpose of the study to assess if a resection of the uterine scar from a previous     Cesarean section during a second Cesarean section could lead to a decrease in risk for     subsequent pregnancies.   "
44479|NCT02703506|"     This project aims to study the effectiveness of a pain education program in the improvement     of chronic pain and disability/impairment. Assuming the definition established in the United     States in 1975 on the fourth working group of the National Conference on Preventive Medicine:     Health education must be a process that informs, motivates and helps people to adopt and     maintain practices and healthy lifestyles, environmental advocates changes necessary to     facilitate these objectives and professional training and directs research towards the same     objectives.  Once the need of educating patients is stablished on subjects with diseases, it     is necessary to encourage them to actively participate on the control of them and to achieve     significant improvement of adherence   "
44480|NCT02703493|"     This is a Phase I study looking to evaluate the safety of dose escalated stereotactic     radiotherapy (SRS) without exceeding the maximum tolerated dose in patients with high-risk     human papilloma virus (HPV)- unassociated oropharyngeal squamous cancer.   "
44481|NCT02703480|"     The proposed study design is a randomized controlled trial, split mouth design, to compare     the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and     Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE)     membrane.   "
44482|NCT02703467|"     The purpose of this study will be to determine whether there is any role for measuring     Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with     asthma.      The investigators will recruit patients with a range of severity of asthma and health     volunteers. Levels of Hydrogen Sulphide will be measured in exhaled breath and blood. Also     exhaled Nitric Oxide, Spirometry and asthma symptom scores will be measured at each study     visit. Participants will attend either 2 or 4 separate visits.      The investigators will determine whether there is a relationship between exhaled Hydrogen     Sulphide and asthma severity.   "
44484|NCT02703441|"     The research and innovation programme Food´n´Go - Empower aims to develop, test and implement     health technology solutions for active involvement and increased empowerment of elderly     patients and their relatives solving well-known problem areas as malnutrition and inactivity.      The prototype was developed in 2013. The project is a collaboration between departement of     internal medicine in Copenhagen University Hospital, one local municipality and a private     it-company. The technology is a tablet computer, used by elderly patients to order and     register food intake during hospitalization. The tablet is also used to get inspiration for     physical activities during hospital admission and after discharge and for registration of     physical activities.      The aim of this study is to test if an adjusted version of the Food´n´Go technology through     active involvement of the elderly patient can prevent weightloss and loss of muscle strength     during hospitalization and after discharge.   "
44485|NCT02703428|"     The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center     post-market study to evaluate the low profile (14F) Ovation® Abdominal Stent Graft Platform     when used in the endovascular treatment of female patients.   "
44486|NCT02703415|"     Management of acute pain is one of the most important tasks of perioperative pediatric     anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia,     on its 15th annual meeting as a basic human right, irrespective of age, treatment primary     service responsible for the patient care. Pro-inflammatory cytokines increased by surgical     trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen     free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central     sensitivity and hyperalgesia. There has been growing interest in determining the possible     immune consequences of analgesic administration for the management of postoperative pain   "
44487|NCT02703402|"     ABSTRACT: Low back pain is one of the most frequent causes of incapacity. The prevalence of     this syndrome is 60-85% for the survival of the individuals. Among the most promising     strategies of low back pain intervention, is the physical activity that is usually associated     with a long list of health benefits.   "
44509|NCT02703116|"     The purpose of this study is to assess the feasibility, acceptability and test the initial     efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with     STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who     have sex with men) and YTW (young transgender women) on frequency of substance use and     engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis)     care continuum.   "
44488|NCT02703389|"     The amount and speed of emergency department (ED) discharge instructions often make it     difficult for patients/caregivers to know the final diagnosis and to remember instructions.     We hypothesize that a video on ear infections and antibiotics' role in their management will     facilitate caregiver understanding and will increase the likelihood of caregivers properly     following discharge instructions.      To verify this hypothesis, a large multi-centre clinical trial is needed. Prior to this, it     is only ethical to conduct a smaller 'pilot' trial. Previously healthy children (6 months-5     years) diagnosed with mild ear infections at the McMaster Children's Hospital ED will be     eligible to participate. If the child and caregiver decide to participate, before discharge,     the caregiver will either: 1)watch the aforementioned video, 2)be given a pamphlet with the     same information, or 3)standard of care (no additional information). Participants will fill a     knowledge survey before discharge. The research assistant will contact all participants by     phone to determine if the caregiver followed the discharge instructions.   "
44489|NCT02703376|"     This study is safety and proof-of-concept study for oral prednisolone in the treatment of     esophageal stricture after esophageal surgery. The patients who develop the severe esophageal     strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety     and Success rate of this treatment.   "
44490|NCT02703363|"     Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients     with bipolar disorder experience persistent depressive symptoms that do not respond to     standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may     reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central     nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug     in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor,     has also shown promising results in the treatment of depressive symptoms. In this factorial     design, double blind, randomised controlled trial the investigators will determine the     efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in     patients experiencing a depressive phase of bipolar I or II disorder. The investigators     hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement     in depressive symptoms in participants in comparison with placebo.   "
44491|NCT02703350|"     The study will be conducted in participants with type1 diabetes on insulin injection therapy     to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar     levels. Side effects and tolerability will be documented. The study will be conducted in two     parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in     both parts.   "
44492|NCT02703337|"     The study will be conducted in participants with type 2 diabetes on insulin injection therapy     to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar     levels. Side effects and tolerability will be documented. The study will be conducted in two     parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in     both parts.   "
44493|NCT02703324|"     This study will evaluate a blood sugar lowering insulin, LY900014, delivered by an insulin     pump continuously under the skin. The study will be conducted in participants with type 1     diabetes mellitus to investigate how the human body processes LY900014 and its effect on     blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability     will be documented.   "
44494|NCT02703311|"     The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary     (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed     on the beating heart through a transseptal approach. The Cardioband is deployed along the     posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on     the beating heart. A CE mark study with 30 subjects has been completed and documented     reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in     subjects with moderate to severe MR.      Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure     symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa),     severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system     in the post-marketing setting.   "
44495|NCT02703298|"     TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer     therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer     cell lines. The objectives of this study are to determine the safety profile of TRX-818     including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) in     Asians and determine the recommended dose and regimen(s) to initiate Phase 2.   "
44496|NCT02703285|"     The study aims to validate the interpretation of breath sounds by medical personnel   "
44497|NCT02703272|"     The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric     participants is consistent with that in adults (part 1) and to assess efficacy (event-free     survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and     etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI)     background therapy compared to RICE or RVICI background therapy alone (part 2).   "
44498|NCT02703259|"     The purpose of the investigators' study is to assess the efficacy of a single dose of     preoperative gabapentin within an enhanced recovery after surgery protocol in acute     postoperative pain reduction for women undergoing a minimally invasive hysterectomy.     Participants who consent to participate will be randomized to either a control group without     gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery.     The investigators will collect data on postoperative narcotic use, subjective pain as rated     by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.   "
44510|NCT02703103|"     The aim of the study was to evaluate the new mechanical chest compression machine LifeLine     ARM in healthcare professionals in simulated model of cardiac arrest.   "
44511|NCT02703090|"     The primary aim is to utilize near-infrared spectroscopy (NIRS) in patients under general     anesthesia to measure changes in brain blood flow in the bilateral somatosensory cortices and     the prefrontal cortices in response to noxious stimulation.   "
44512|NCT02703077|"     This study compare 2 techniques to treat difficult bile duct stones endoscopically   "
45173|NCT02694419|"     The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few     attentions. There is a lack of evidence to whether the BMI affects the endometrial blood     flow, which is necessary for implantation.   "
44499|NCT02703246|"     In this study the investigators will perform a randomized trial to compare the surgical     outcomes of vaginal versus abdominal morcellation of the uterus during hysterectomy. In     minimally invasive gynecologic surgery small incisions are made in the abdomen and pelvis so     that a hysterectomy can be performed by laparoscopy. The challenge is then to remove the     uterus, which may be quite large, through these small incisions. One option is to morcellate     the uterus and remove the tissue through either a small abdominal incision or an incision in     the vagina. When an organ is morcellated it is cut into smaller pieces so that it can be     removed, section by section, through a small incision. The investigators will compare these     two methods of tissue removal to see whether one results in better surgical outcomes or     increased intra-operative or post-operative complications. The primary outcome will be the     time it takes to perform the surgery (operative time). Secondary surgical outcomes that will     be studied include the amount of blood lost during surgery, post-operative complications, and     readmission to the hospital.   "
44500|NCT02703233|"     This will be a randomized control trial. All patients for whom an emergency provider     determines that abscess drainage or laceration repair are necessary will be considered for     enrollment. The provider must be willing to participate in the study and be certified to use     Nitrous oxide. The investigators providers completed a training course to be certified to use     Nitrous oxide. The patient must be age 18 or greater, consent to participate in the study,     and be able to complete a satisfaction survey. If the patient states there is a possibility     of pregnancy, the investigators will regress to our standard of care and perform a urine     pregnancy test. Patients with a first trimester pregnancy will be excluded. Patients who     agree to enroll in the study will be randomized to Nitrous oxide versus oxygen (to be     administered through the same system), and will complete a survey after the procedure, as     will the provider. There will be a separate block randomization for each procedure. Providers     may select other agents of choice for analgesia/sedation, such as local anesthesia, and pain     medications, based on their clinical judgment. If the patient appears to have inadequate     analgesia during the procedure, the provider can elect to treat as is typically done (pain     medications or local anesthetics) at their discretion. The survey will ask patients to give a     self-reported pain score before and during their procedure (both to be completed after the     procedure). It will also ask the patient/guardian and provider for a satisfaction level with     the analgesia during the procedure. In addition, side effects and procedure start and stop     time will also be documented. In addition to the survey, the investigators will document     clinical characteristics including diagnosis, size of laceration or abscess, additional     medications required and dosages, comorbidities, age, and gender. Other data that will be     gathered will include which adjunctive analgesics/anesthetics were used.   "
44501|NCT02703220|"     Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and     leads to increased morbidity and mortality in this population. The proposal aims to identity     whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing     and eliminating sleep apnea in the elderly via different mechanisms. This proposal will     enhance the investigators' understanding of the pathways that contribute to the development     of sleep apnea in the elderly. The investigators expect that the results obtained from this     study will positively impact the health of Veterans by identifying new treatment modalities     for sleep apnea. A cumulative effect of the investigators' research will fulfill the     long-term goal of improving the quality of life of elderly Veterans suffering from sleep     apnea and its potential life-threatening complications.   "
44502|NCT02703207|"     Cognitive dysfunction in the aging Veteran population is a growing health concern in the     Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the     risk for cognitive dysfunction. The investigators sought to investigate whether these two     highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance     cognitive impairment in the elderly Veteran population. Thus, the investigators will study     whether elderly patients with Overlap syndrome have increased cognitive deficits compared     with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP)     has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive     decline in COPD may be reversible through treatment with long-term oxygen therapy. The     investigators will also study whether treatment with positive airway pressure (PAP) and     supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life     of elderly Veterans.   "
44503|NCT02703194|"     The study has been designed as a 12-month, open-label, randomized, controlled study comparing     the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in     treating patients with IgG4-related disease.   "
44504|NCT02703181|"     The current study is designed to assess the safety, tolerability and pharmacokinetics (PK) of     additional repeat doses of epelsiban in healthy females, and will be the first dosing     experience of repeat dosing at higher doses in women with this compound.      This study is a 14 day, randomized, placebo-controlled, double blind (sponsor unblind),     repeat dose, ascending cohort, dose escalation study in healthy, female volunteers. Upon     successful completion of the Screening period, a subject will be enrolled in the study. The     study will be composed of three periods: Screening, Treatment and Follow-up. A subject's     total time involved in the study will be approximately six weeks.      Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort. Ten     subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo (n=2).   "
44505|NCT02703168|"     This is a follow-up study with patients, who participated in the Straumann clinical study     CR06/03. The objective is the assessment of long-term data (8 and 10 years after     implantation) on the performance of immediate and early (28-34 days post implantation)     non-occlusal loaded Straumann Tissue Level Implants with SLActive surface when used to     support single crowns or 2-4 unit fixed dental prostheses in the posterior maxilla and     mandible.      The primary objective is of the study is to analyse the change in crestal bone levels 8 and     10 years post-surgery compared to 6 months, 1 year, 2 years and 3 years post-surgery in the     immediate and early loading group.   "
44506|NCT02703155|"     The aim of this study is to establish if the self-administered electronic Oral Glucose     Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are     between 10 and 17 years of age with CF.   "
44507|NCT02703142|"     Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical     esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and     strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic     evaluation about reconstructive organs after esophagectomy. The investigators evaluate     endoscopic predictions using classifications in acute phase after esophagogastrostomy.   "
44508|NCT02703129|"     Migraine is a common medical condition. Several studies suggest that obesity and/or weight     gain are risk factors for aggravating migraine course, especially increase the frequency of     headache episodes. The aim of the current study was to evaluate whether nutritional     intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of     patients with migraine.   "
44513|NCT02703064|"     Poly cystic ovary syndrome (PCOS) is the most common endocrine disorder in women of     reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a     hormonal disorder that involves multiple organ systems within the body. Its cardinal features     are Hyperandrogenism and polycystic ovary (PCO) morphology. Women with PCOS may complains     about irregular menstrual periods or heavy menstrual bleeding, infertility, excessive growth     of coarse facial and body hair, obesity, oiliness of the skin, seborrhea, and cystic acne.   "
44514|NCT02703051|"     Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study     conducted at one study center in the United States (US).   "
44515|NCT02703038|"     Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output.     Catches diagnostic management, and therapeutic monitoring of these patients remain highly     variable from one center to another and even from one doctor to another within the same team.     The management protocols are often not standardized or non-existent.      It appears therefore necessary to make an inventory of the management practices of the CS in     France in 2016, prerequisite to a common work of standardization of practices and the     creation of specialized networks to support these complex patients.   "
44516|NCT02703025|"     Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study   "
44517|NCT02703012|"     First clinical application of an algorithm for individual adjustment of ventilator settings     using electrical impedance tomography.   "
44518|NCT02702999|"     The purpose of this study is to see whether women at a gestational age of 30 weeks or more     without comorbidities, does performance of serial 3rd trimester growth ultrasounds increase     the frequency of identifying abnormalities in fetal growth or amniotic fluid, when compared     with women who only receive indicated ultrasounds?   "
44519|NCT02702986|"     10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant     treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating     Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated     as primary objective. Secondary objectives will be QoL after imILT, study of the immune     reaction after imILT, oncological analysis of patients suffering from LAPC submitted to     imILT.   "
44520|NCT02702973|"     The high doses of interferon α-2b therapy in patients with melanomas of the skin may induced     retinopathy, especially in the patients with hypertension or diabetes, so these patients     should be followed up after treatment.   "
44521|NCT02702960|"     This trial is a phase II, single arm, open-label, single center study to assess a     reduced-intensity conditioning regimen, bone marrow transplantation and high dose PTCy in     recipients of a partial liver allograft from a Human Leukocyte Antigen (HLA)-matched or     -haploidentical living related donor in patients with HCC.      The primary objective of this trial is to characterize recurrence-free survival at 1 year     following bone marrow transplantation among recipients of prior partial liver transplantation     from the same donor.   "
44522|NCT02702947|"     Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate Prunus     domestica bark contains three groups of active constituents: phytosterols (including     beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic     esters of long-chain fatty alcohols (including ferulic esters of docosanol and tetracosanol).      The phytosterols, particularly beta-sitosterol, are found in numerous plants and are     anti-inflammatory, inhibiting the synthesis of prostaglandins. Beta-sitosterol has been shown     to be useful in cases of BPH by helping to reduce the normally elevated levels of     prostaglandins in these patients.   "
44523|NCT02702934|"     Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized     controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based     rusks in overweight subjects.   "
44527|NCT02702882|"     The study evaluates the effect of Fenugreek seed extract (Furosap) in management of     symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek seeds     extract are known to possess protodioscin and the extract is reported to improve sperm count,     sperm morphology and protective effect on male reproductive system. All the participants will     receive one capsule (500 mg) of furosap once a day.   "
44528|NCT02702869|"     A system for prospective data-collection is being implemented by the Duke Cleft &     Craniofacial Center so that it may analyze clinical and psychosocial outcomes related to care     of the child with cleft lip and/or palate (CL/P), compare its performance with those of other     cleft centers, and identify opportunities for quality improvement.   "
44529|NCT02702856|"     Validate a non-DRE exosome gene expression test, with an NPV >/= 90% certainty, will exclude     the presence of high gleason grade/ score (>/=7) prostate cancer in a prostate needle biopsy.   "
44530|NCT02702843|"     The Study is designed to compare the effectiveness of Near Infrared Fluorescence     Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying     the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic     Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory     Ducts) during laparoscopic cholecystectomy. The aim is to demonstrate that NIFC performs     better than standard white light (WLI) alone in visualizing and identifying     extra-hepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common     Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before     and after dissection during Laparoscopic Cholecystectomy (LC).   "
44531|NCT02702830|"     This pilot research trial studies magnetic resonance imaging (MRI) and cardio     (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients with     stage I-III breast cancer after treatment with chemotherapy drugs called anthracyclines.     Anthracyclines are related with heart problems, cardiac abnormalities, bone and muscle     dysfunction. Patients with breast cancer who are exposed to anthracycline drugs may also     experience progressive fatigue and exercise intolerance which may limit daily activities and     is an important barrier for patients returning to work. Using MRI and cardio-pulmonary     exercise testing (CPET) may help doctors understand the causes of fatigue and exercise     intolerance in patients receiving anthracycline chemotherapy and this may also allow doctors     to plan better treatments to protect patients' heart, cardiovascular system, bone and muscle     function.   "
44532|NCT02702817|"     Two-year double-masked trial of over-the-counter dosage of naproxen sodium vs placebo in 200     cognitively normal participants with a parental or multiplex first-degree family history     Alzheimer's disease (AD) dementia. Primary outcomes are decline in cognitive function and     slope of change in a summary Alzheimer Progression Score derived from serial assessment of     neuroimaging, biochemical, and sensori-neural biomarker indicators of pre-clinical disease --     all believed likely to reflect progress of preclinical AD in this high risk cohort.     Approximately 2/3 of participants have volunteered also for serial lumbar punctures for     analysis of cerebrospinal fluid. A two-year off-treatment delayed-washout phase is planned to     examine sustained treatment effects and evidence of disease modification.   "
44533|NCT02702804|"     Exercise has been shown to improve quality of life in people with multiple sclerosis but most     exercise programmes are carried out at low to moderate intensities. The next stage in the     management of the condition is to establish if people with mild Multiple Sclerosis can     exercise, safely and effectively at a higher intensity. High intensity interval training     (HIIT) involves repeated bursts of hard exercise interspersed with periods of rest. High     intensity interval trainingcould be a time efficient and safe option for people with Multiple     Sclerosis. Potential improvements are; cardiovascular fitness, resistance to fatigue,     balance, quality of life and attitude to physical exercise.      Participants will attend two sessions per week for 6 weeks. Each session will involve 6-10     sets of 60 seconds of high intensity cycling followed by 60 seconds rest. Potential     participants must have a clinical diagnosis of Mulitple Sclerosis for more than 3 months, an     EDSS score of less than 2.5, aged 18-65, and had no more than one relapse in the last 2     years.      From this study the investigators hope to discover if High Intensity Interval Training is a     safe and enjoyable form of physical activity for people with mild Multiple Sclerosis. This     will then hopefully lead to further large research trials.   "
44534|NCT02702791|"     This randomized control trial will investigate whether the implementation of a telecoaching     program, initiated during pulmonary rehabilitation, is able to increase and maintain physical     activity and general benefits until six months after rehabilitation discharge.      After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be     randomized to either an intervention group which receives an additional telecoaching program     on top of the pulmonary rehabilitation, or to the usual care group, which only receives     rehabilitation program. Apart from the added telecoaching program to the intervention group,     the rehabilitation program will be identical and last for another three months (2 times a     week). After discharge, both groups will be followed up for six months.   "
44535|NCT02702778|"     A four-week, randomized, controlled, open-label trial of DR prednisone in which patients     receive in period 1 one of three-night time doses of treatment (4mg, 7mg or 10mg) for two     weeks followed in period 2 by treatment with 15mg IR prednisone in the morning for two weeks.     Period 1 is randomized and open-label and period 2 is open label. Before enrollment and     randomization patient diagnosis and responsiveness to 15mg IR prednisone in the morning is     established. 45 patients will be randomized, 15 patients in each treatment arm.   "
44536|NCT02702765|"     The aim is to investigate macrophage activation markers and correlations to liver fibrosis in     patients with Wilsons Disease. Researchers wish to investigate associations to neurologic and     metabolic liver function. Researchers will assess this by comparing blood samples with     fibrosis and liver function analyses. This study provides new insight into macrophages and     their involvement in Wilsons Disease.   "
44549|NCT02702596|"     The proposed study seeks to establish the feasibility of universal screening for depression     in an adult primary care safety net setting, measure the effectiveness of a culturally     appropriate depression education intervention to reduce stigma and increase uptake in     depression treatment among Hispanics, and implement a Measurement-Based Integrated Care     (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care     management strategies.   "
44537|NCT02702752|"     The aims of the present study are to measure dynamic changes over time in the plasma level of     SDF-1α in patients with confirmed diagnoses of AMI, AF and CHF and in so doing:        1. Monitor the plasma level of SDF-1α at the diagnosis, during and after the long term          treatment of AMI, AF and CHF. The SDF-1α level of patients is expected to decrease          during treatment of the aforementioned conditions.        2. Correlate the plasma level of SDF-1α in relation to clinical, biochemical          characteristics of Acute Myocardial Infarction(AMI), Atrial Fibrillation(AF) and          Congestive Heart Failure (CHF). In so doing, the investigators expect that SDF-1α will          correlate with the severity of heart disease.        3. Study the dynamic of SDF-1α pertaining to its property as prognostic indicator for the          long term follow up risk of readmission and mortality of patients diagnosed with AMI, AF          or CHF.   "
44538|NCT02702739|"     The proportion of HCV infected patients over age 65 years in Western countries is increasing.     This growth and the advent of new antiviral therapy bring into the question the real world     efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat     dose of ribavirin (RBV) in elderly patients compared to younger patients.   "
44539|NCT02702726|"     The aim of this study is to compare the effects of dietary fats, ingested in two physical     forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI     18-24.9 kgm-2) or overweight (BMI>25kgm-2) adults.   "
44551|NCT02702570|"     The investigators are planning to recruit approximately 30 study participants aged 50 years     and older that will undergo a 4 week attention and emotion regulation intervention. The     intervention systematically targets thoughts, emotions and behavior in order to promote     quality of life and advance successful brain aging. The investigators will assess the     feasibility of recruiting and retaining participants for an attention and emotion regulation     intervention. In addition, the investigators will determine the efficacy of the intervention     to enhance and promote quality of life, sustained attention, emotions, motivation and     cognitive health.   "
44552|NCT02702557|"     This feasibility study investigates if frail elderly and hospitalized patients are able to     perform unsupervised elastic band exercises as a supplement to their usual supervised     physiotherapy sessions and how much training they perform during their hospitalization. It is     also investigated how the frail elderly and the health personnel experiences the unsupervised     elastic band exercises.   "
44540|NCT02702713|"     This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary     intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be     recruited. Subjects will be eligible to the study if they present with two to four of the MS     diagnostic criteria, at least one of them being:        -  fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR        -  HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110          mg/dL).      Each of the four recruiting centres will recruit 200 volunteers. Participants will be     randomly assigned to one of four groups to receive either:        -  Dairy BEF + egg placebo + bakery placebo        -  Egg BEF + dairy placebo + bakery placebo        -  Bakery BEF + dairy placebo + egg placebo        -  Dairy, egg and bakery placebo      Participants will be required to consume all three of the allocated products each day for 12     weeks.      Eligible volunteers will be included and randomly allocated to one of the four groups. At     baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting     centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will     complete questionnaires relating to their satisfaction with the food products, compliance to     consumption of the study food products, and any gastrointestinal side effects or     health-related adverse events that have occurred in the previous 3 weeks.      At each recruiting centre 40 participants will be required to take part in additional     activities, these are: stool sample collection, adipose tissue aspiration, body composition     analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.   "
44541|NCT02702700|"     This clinical study aims to explore intrapleural low-dose Visudyne®-mediated photodynamic     therapy (photo-induction) as a pathway to promote the uptake of systemically administered     Lipoplatin™ in pleural malignancies of patients undergoing video-assisted talcage for their     malignant pleural effusions. Photo-induction is expected to overcome the chemo-resistance of     pleural malignancies for cisplatin-based chemotherapeutics and thereby improve local tumor     control.   "
44542|NCT02702687|"     This randomized controlled trial will include Latino and Black adolescents with asthma ages     10-17 years old and their caregivers. Participants will be recruited from clinics in the     Bronx, NY. The primary aims are to examine the efficacy of peak expiratory flow (PEF)     prediction with feedback versus control feedback on 1) under-perception of asthma symptoms 2)     controller medication adherence and 3) asthma control and emergency health care use. These     aims will be examined across a 1-year follow-up. An exploratory aim examines the hypothesized     pathway that the PEF intervention reduces under-perception of symptoms, shifts illness     representations toward the professional model and increases adolescents' and parents' asthma     management self-efficacy, resulting in greater medication adherence and improved asthma     control.   "
44543|NCT02702674|"     The effect of coadministration of oral propranolol to oxytocin on induction of labor.   "
44544|NCT02702661|"     A prospective randomised controlled trial involving patients undergoing hip arthroscopy.     Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or     Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic.     Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is     assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the     post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery.     Secondary outcome measures were the frequency and the dose of morphine and other medications     consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain     or medications used for pain relief in both the groups.   "
44545|NCT02702648|"     The primary purpose of this first-in-man study is to investigate whether a new drug for     neurological disorders is safe and well-tolerated when administered orally to healthy adults   "
44546|NCT02702635|"     Dynamic contrast-enhanced (DCE) MRI gives quantitative and semi-quantitative information     about the integrity of the vascular system and can be used to quantify blood-brain barrier     (BBB) integrity. The BBB plays a pathophysiological role in diabetes, cognitive disorders     such as mild cognitive impairment, Alzheimer's disease, multiple sclerosis, and chronic     traumatic encephalopathy. Although dysfunctional, changes in BBB integrity for these     conditions are thought to be subtle and close to intact values. Recent studies have shown it     is possible measure small changes in the BBB integrity as an early sign of disease using DCE     MRI. The objective of this study is to apply an optimized DCE imaging protocol and novel     image post-processing to obtain new information about the BBB integrity in trauma. These     techniques show promise for both improving clinical diagnosis, and elucidated the physiology     or various disease processes.   "
44547|NCT02702622|"     The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic     biofortified bananas.   "
44548|NCT02702609|"     Randomized Controlled study to compare the effectiveness of two different treatment     approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge     preservation of an atraumatic extraction socket site compared to allograft with collagen     plug.   "
44550|NCT02702583|"     Febrile neutropenia (FN) is a clinically important adverse effect of myelosuppressive     chemotherapy. If patients present with FN, attention is focussed on well-recognized sites of     origin of infection: the airways, urinary tracts, and skin. However, infections can be only     documented clinically in about two-third of febrile episodes, whereas a causative microbial     pathogen cannot be identified in the majority (>70%) of cases.      Pre-treatment oral evaluation aimed to identify and eliminate oral/dental foci is only     routinely used in patients at high risk for oral complications (i.e. head and neck cancer     patients and stem cell transplantation recipients). However, any patient treated with     myelosuppressive chemotherapy, be it for cure or palliation, is at risk of developing     infection in and/or originating from the oral cavity. Nevertheless, in these patients dental     screening is somewhat randomly employed at the oncologist's discretion.      More insight into the pre-treatment oral condition and its potential role in FN is mandatory,     particularly considering the growing numbers of older patients retaining their natural     dentition and the increase of dental diseases and cancer incidence with age.      In addition, oral diseases may aggravate chemotherapy-induced oral mucositis (OM). OM is     associated with an inflammatory response, which together with ulcerations providing a portal     of entry for bacteria, can result in FN and systemic inflammatory syndrome (SIRS) and/or     sepsis. Evidence suggests that microorganisms are involved in the pathobiology of OM, but no     longitudinal studies using open-end sequencing are available.      Furthermore, comparing bacteria identified in blood cultures in febrile patients with those     of the oral cavity will expand the knowledge on the role of the oral cavity as a potential     source of bacteremia.      The investigators expect that the results will provide a scientific base for subsequent     intervention studies on the efficacy of dental screening and elimination of foci, and other     interventions aimed at modifying the oral environment before and during chemotherapy.   "
44554|NCT02702531|"     Endoscopic surgical procedures are becoming more common in all surgical specialties including     gynecology that was one of the pioneers in this field specialties.      Maintaining a quality field of view is important not only to patient safety but also for the     quality of surgery and reduced surgery time.      The lenses of vision which are located at the distal end of the optical vision are during     endoscopic surgery in direct contact with the anatomical structures. These lenses are found     soiled by several phenomena whose appearance of a mist which constitutes a major obstacle to     a clear field.      The alteration of the vision requires the surgeon extraction optics in order to achieve a     cleaning of the lens. This cleaning is carried out as many times as necessary. Many     strategies have been developed to improve the quality of vision. These methods relate to both     the development of new optical vision but also the development of the lens cleaning material.     In practice, the cleaning is carried out using a sterile swab sterile saline associated with     the betadine iodine.      Recently a new material called FloShield Air System Vision System has been proposed and has     the particularity to combine both anti-fog product and a temperature control system in     contact with the lens in order to fight against condensation and smoke. The purpose of this     is to improve the quality of vision by reducing the fogging phenomenon and no change of the     temperature in contact with the lens (moisture reduction). Accordingly, it is assumed a     reduction in the number of stay and a reduction in the specific operative time associated     with this cleaning.      In this context, we wish to evaluate the effectiveness of FloShield Air System vision system     on the basis of a comparative, prospective, randomized against the reference method (sterile     water solution + Betadine) during endoscopic surgery gynecology.   "
44555|NCT02702518|"     The purpose of this study is to evaluate the tolerability and preliminary efficacy of rhDNase     I eye drops in patients with ocular Graft-vs.-Host disease (oGVHD).   "
44556|NCT02702505|"     Mineral trioxide aggregate has been previously FDA approved as an endodontic filler. Its use     in vital teeth has demonstrated significant color change post-treatment leaving it     ineffective for esthetic use..      The new formulation will be tested to see if has the same effect.   "
44557|NCT02702492|"     This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the     treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).   "
44558|NCT02702479|"     The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its     introduction as a popular sweetener in the United States has led to much concern regarding     its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic     disorders (3).Unlike sucrose which contains equal proportions of fructose and glucose bound     by an α-glycosidic bond, HFCS contains 42-55% of fructose to glucose in a free (unbound) form     (4). Despite these differences in composition, both sugars possess identical energy     contribution on a gram to gram basis (4). However, the higher ratio of fructose to glucose in     HFCS has led to the hypothesis that HFCS may uniquely contribute to cardiometabolic risk,     more so than sucrose, through proposed differences in fructose metabolism, endocrine and     hedonic properties (5). We will conduct a series of systematic reviews and meta-analyses to     assess the role of HFCS versus sucrose under energy matched (isocaloric) conditions on     cardiometabolic risk.   "
44559|NCT02702466|"     The main objective of this work is to demonstrate superiority to three months of a     standardized short course of SPA Therapy of 6 days associated with personalized health     education program compared to conventional therapy in the management of MSDs on the     functional capabilities of the employees in their daily lives (personal or professional)   "
44611|NCT02701777|"     The overall goal is to develop new clinical approaches to restore upper-limb function after     incomplete cervical spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in     controlling upper-limb function. Paired pulse induced spike-timing dependent plasticity     (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs)     resulting in temporary improvements in upper-limb function in humans with incomplete cervical     SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance     plasticity and behavioral recovery.   "
44613|NCT02701751|"     The primary purpose of this study is to examine the effects of chronic exercise training and     an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g.,     glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous     adipose tissue structure and metabolic function in overweight adults.   "
44560|NCT02702453|"     There is increasing evidence that sexual activity is associated with greater resilience and     higher well-being in older adults. Even at a time of stress, and even during a late stage of     illness, men and their partners turn to sexual intimacy to increase a sense of connection,     comfort and support. The Sexual Recovery intervention seeks to address an unmet need of     prostate cancer survivors and their partners who are at risk for poor mental health and     decreased quality of life as a result of sexual dysfunction.      By using technology, the intervention will be widely accessible to survivors, the majority of     whom do not currently have any access to sexual health expertise. The content and format of     the intervention seeks to empower prostate cancer survivors and partners with knowledge and     strategies to improve their sexual function, sexual confidence and their sexual relationship.     The intervention begins prior to and continues following their definitive treatment. This     may, in turn, improve mental health and quality of life.      In a broader sense, this intervention will be transferable. With appropriate modifications,     it can become an accessible sexual health intervention for populations dealing with other     cancers and chronic illnesses.   "
44561|NCT02702440|"     Consumption of sugar-sweetened beverages (SSBs) has been linked to rising rates of overweight     and obesity. The most prominent mechanism to explain the link between SSBs and obesity is     that liquid calories are not perceived by the body; thereby, promoting less satiety, less     energy compensation and more weight gain than does the same energy consumed in solid form.     This view is supported by pooled analyses of acute preload trials that have primarily     measured food intake as the outcome. Though failure of short-term compensation has been     observed with liquid calories, results from these acute preload trials should not be     extrapolated to infer that liquid energy sources lead to weight gain over the long-term. To     date, it is unclear whether liquid calories have differential effects than solid calories on     body weight gain over the longer term. To increase clarity in this issue, the investigators     propose to conduct a systematic review and meta-analysis from long-term controlled feeding     trials to distinguish the contribution of liquid calories from solid calories on body weight     over the long-term. The findings generated by this analysis will improve the health of     consumers through informing evidence-based guidelines and improving health outcomes by     educating healthcare providers and patients, stimulating industry innovation, and guiding     future research design.   "
44562|NCT02702427|"     Invasive infections with CMV and Adenovirus, not responding to virostatic treatment are     treated with virusspecific donor derived or autologous virusspecific T-cells.   "
44563|NCT02702414|"     This is a efficacy and safety study of pembrolizumab (MK-3475, KEYTRUDA®) as monotherapy in     participants with previously systemically treated hepatocellular carcinoma (HCC). Study     participants may receive pembrolizumab once every 3 weeks for up to 35 administrations (up to     approximately 2 years).      The primary objective of this study is to determine the Objective Response Rate (ORR) of     pembrolizumab given as monotherapy in participants with previously systemically treated HCC   "
44564|NCT02702401|"     This is a study of pembrolizumab (MK-3475) in participants with previously systemically     treated advanced hepatocellular carcinoma (HCC).      The primary objectives of this study are to determine 1) Progression-Free Survival (PFS) and     2) Overall Survival (OS) of pembrolizumab plus best supportive care (BSC) compared with     placebo plus BSC. The primary hypotheses of this study are: 1) pembrolizumab plus BSC     prolongs PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, assessed by a     blinded central imaging vendor compared to placebo plus BSC, and 2) pembrolizumab plus BSC     improves OS compared with placebo plus BSC.   "
44565|NCT02702388|"     This is a multicenter, randomized, double-blind study being conducted as a postmarketing     requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower     starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has     a better safety profile in participants with radioiodine-refractory differentiated thyroid     cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.   "
44566|NCT02702375|"     There is an urgent need for stronger evidence to support recommendations for the role of     sugars in diabetes and related cardiometabolic diseases. Although large prospective cohort     studies have shown a significant positive association of fructose-containing sugars-sweetened     beverages with incident obesity, diabetes, heart disease, and stroke, these associations do     not appear to hold true for total fructose-containing sugars and other important sources of     free fructose-containing sugars such as pure fruit juice, yogurt, or even cakes and sweets.     As dietary guidelines have moved away from macronutrient centric recommendations towards more     food and dietary-pattern based recommendations, this inconsistency in the data has not been     appreciated. There remains a focus on free sugars, in the absence of sufficient information     on the role of different food sources of fructose-containing sugars in diabetes and related     cardiometabolic diseases. A systematic review and meta-analysis of prospective cohort studies     is considered to be the Gold Standard of evidence. To provide evidence-based guidance to     support the development of public health policy in relation sugars and the primary prevention     of diabetes, we will conduct a series of systematic reviews and meta-analyses of the relation     of food sources of fructose-containing sugars with incident type 2 diabetes and related     cardiometabolic diseases in prospective cohort studies.   "
44567|NCT02702362|"     In this study researchers will apply transcranial direct current stimulation (tDCS) for 5     consecutive days in chronic patients in minimally conscious state (MCS).   "
44568|NCT02702349|"     The incidence of reactions during penicillin challenge tests among children with suspected     penicillin allergy   "
44612|NCT02701764|"     Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in     some patients, they can persist. The investigators believe that in some individuals, dry eye     symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The     investigators wish to study if a medication, called pregabalin, can protect corneal nerves at     the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6     months after surgery. This medication has been used in a similar way to reduce the frequency     of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied     in LASIK surgery.   "
44819|NCT02699073|"     The purpose of the study is to evaluate the performance of various tumor response criteria     (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity.      Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic     texture analysis (CTTA)   "
44569|NCT02702336|"     The primary aim is to promote healthy lifestyles among young people, through the design and     implementation of health promotion activities carried out by adolescents (12-14 years old) to     scholars of primary education (8-10 years old), using social marketing and peer-led strategy.      The secondary aims are: 1) to increase fruit and vegetable consumption and physical activity     practice in scholars and adolescents; 2) to reduce sedentary lifestyles, sugary drinks and     fast-food in scholars and adolescents.      The EYTO-kids program is a randomized, parallel, intervention program with control group,     with a 2 academic courses, 2015-2016 to 2016-2017 (10 months in total), in Reus (Spain).      To achieve the aims, social marketing and peer-led methodologies will be used at the     intervention design and implementation. Adolescents from secondary education (1st /2nd ESO:     Educación Secundaria Obligatoria-Obligatory Secondary Education) will design and implement     activities to scholars from primary education (3rd/4th primary education).      The adolescents from the intervention group will design and implement activities to implement     them in to children, and the control group will not receive any kind of intervention (only     the assessment).      Participation will occur according to the randomized sample size, where a minimum of 208     adolescents (104 as intervention and 104 as control group), and 602 scholars (301 as     intervention and 301 as control group) will be involved.      The inclusion criteria are: to have signed informed consent (from mother/father/guardian of     the participant), to provide basic demographic data, to assist participating schools and to     answer a lifestyle questionnaire.   "
44570|NCT02702323|"     This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with     pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib     and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other     half will receive TACE therapy alone.   "
44571|NCT02702310|"     This clinical trial studies low- dose total skin electron therapy in treating patients with     stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or     has returned after a period of improvement (relapsed). Radiation therapy uses high energy     electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which     the patient receives total skin electron therapy while standing on a rotating platform.     Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells,     while having fewer side effects, and may allow therapy to be repeated in future if clinically     indicated.   "
44573|NCT02702284|"     The ability to communicate with patients is profoundly impacted by their health literacy -     the ability to interpret documents, read and write prose, use quantitative information and     speak and listen effectively. Limited health literacy is commonplace and associated with     multiple poor health outcomes including frequent readmission's and high mortality. Advance     directives are an important tool in respecting patient autonomy in health care interventions.     Advance directives can also reduce health care costs by avoiding unwanted, unnecessary care     at the end of life. At the University of Florida (UF) Health currently an initiative is     underway to improve the delivery of advance directives to patients in the hospital as well as     the outpatient clinics.      The aim of this research study is to enhance completion rates of advance directives by taking     into consideration a patient's health literacy level. Specifically, the investigators plan to     assess the impact of an ambulatory intervention on the completion rate of advance directives     for patients with adequate and limited health literacy. The hypothesis is that both groups     (adequate and limited health literacy) will benefit from the intervention, but patients with     limited health literacy will show a greater improvement in the advance directives completion     rate.   "
44574|NCT02702271|"     The study is a prospective, non-randomized, multi-center investigation to establish the     safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for     subjects with non-valvular atrial fibrillation who are eligible for long-term     anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a     non-pharmacologic alternative.   "
44575|NCT02702258|"     Specific aims are:        1. To outline and evaluate key active elements of the Mindfulness-Based Blood Pressure          Reduction (MB-BP) intervention. This aim will be achieved using (a) focus groups of          participants undergoing the MB-BP intervention, (b) discussion with experts (including          cardiologists, epidemiologists, mindfulness experts, mindfulness intervention          instructors) prior to, and following pilot testing of MBHT in participants, and (c)          clinical judgment of the investigators performing the intervention.        2. To evaluate impacts of MB-BP on target engagement (pre-post change in effect size) and          longevity of target engagement (follow-up time-points). Follow-up time periods include          10 weeks, 6 months and 1 year.      This study is a prospective single-arm trial during the intervention development phase.     Following this phase, after the intervention has been further developed, a subsequent study     (with a different clinicaltrials.gov ID #) will utilize a randomized control trial design to     further evaluate causation and effect size.   "
44576|NCT02702245|"     This cross-over intervention study aims to investigate the effect of two doses of thylakoids     to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as     appetite regulating hormones in healthy volunteers.   "
44577|NCT02702232|"     Parkinson's disease (PD) is a multisystem neurodegenerative disorder that is increasingly     recognized in our ageing population. It is characterized by cardinal clinical features     including bradykinesia, tremor, rigidity, and postural instability. For most people with PD,     the most serious concern is with the motor system: stiffness, slowness of movement, impaired     handwriting and coordination, poor mobility and balance. However, more than half of all     people with PD have experienced painful symptoms. Most people experience aching, stiffness,     numbness and tingling at some point in the course of the illness. Defazio et al reported that     pain may begin at clinical onset of PD or thereafter as a non-motor feature of PD.5 Aching     muscles and joints are especially common in PD. Rigidity, lack of spontaneous movement,     abnormalities of posture and awkward mechanical stresses all contribute to musculoskeletal     pain in PD.   "
44578|NCT02702219|"     Mobility training in the form of stretching and flexibility training of our skeletal muscle     is a common exercise. However, the evidence are scare and there are only a few studies     comparing the effect of prolonged static stretching (> 90 sec) and dynamic flexibility     training as to which of these methods has the best length-enhancing effect over time.     Further, in clinical practice concerning low back pain, the possibility of a thigh hamstrings     muscles to affect movement control of the spine is often mentioned, a link not fully explored     in a controlled condition. The purpose of this study is to compare the effect of eight weeks     of dynamic flexibility training versus prolonged static stretching on mobility in the     hamstring muscles in adults with reduced mobility in the muscles at the back of the thigh.     The aim is also to compare the sustained effect of flexibility training between the two     groups, eight weeks after completion of the intervention. Furthermore, the aim is to explore     how different forms of flexibility training affects movement patterns of the lumbar spine in     adult persons with reduced mobility in the hamstrings.   "
44579|NCT02702206|"     A randomized controlled trial to compare the effect of ultrasound-guided hyaluronic or     corticosteroid injections in patients with chronic subacromial bursitis.   "
44580|NCT02702193|"     The study conducts a community-based randomized trial comparing an adaptation of Structural     Ecosystems Therapy (SET), Healthy Home, as an enhancement of substance abuse or mental     health outpatient treatment, to outpatient treatment as usual (TAU) among approximately 172     Black, Hispanic and White nonHispanic mothers enrolled in outpatient substance abuse or     mental health services. The study is conducted with a community partner, Banyan Health     Systems, that delivers substance abuse/mental health treatment and primary care. Data is     collected at baseline and 4, 8, and 12 months postrandomization. The Specific Aims of the     proposed study are to: 1) test the effectiveness of Healthy Home for improving physical and     mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2)     test the effectiveness of Healthy Home for improving health and mental health outcomes of     children of mothers in recovery; 3) test mechanisms of action of Healthy Home (self care,     environmental risk, family functioning and stigma); 4) assess implementation and     sustainability factors and the relationship between fidelity and outcomes; and 5) examine the     interactions of ethnicity and ethnicity related factors on outcomes. Healthy Home is a     manualized, strength-based, directive and process oriented family ecosystemic home health     intervention developed to address the needs of mothers and their children affected by     substance abuse and other mental health disorders.   "
44581|NCT02702180|"     This study evaluates inhaled molgramostim (recombinant human (rh) Granulocyte     Macrophage-Colony Stimulating Factor (GM-CSF)) in the treatment of autoimmune pulmonary     alveolar proteinosis patients. A third of the patients will receive inhaled molgramostim     daily for 24 weeks, a third will receive inhaled molgramostim every other day for 24 weeks     and a third will receive inhaled matching placebo for 24 weeks   "
44582|NCT02702167|"     This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive     transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered     twice daily over 15 days, in patients with a diagnosis of bulimia or anorexia nervosa. The     trial will include structural and functional MRI, EEG, and behavioral measures obtained     before, during, and after treatment.   "
44583|NCT02702154|"     This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive     transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered     twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The     trial will include structural and functional MRI, EEG, and behavioral measures obtained     before, during, and after treatment.   "
44584|NCT02702141|"     The study will examine the safety profile of SGN-CD19B administered as a single agent. The     main purpose of the study is to estimate the highest dose that does not cause unacceptable     side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell     non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3     follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity     of SGN-CD19B will be assessed.   "
44585|NCT02702128|"     Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to     compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.   "
44586|NCT02702115|"     The purpose of the study is to evaluate the safety, tolerability of ascending doses of     SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for     genome editing. It inserts a correct copy of the α-L-iduronidase (IDUA) gene into the Albumin     locus in hepatocytes with the goal of lifelong therapeutic production of the IDUA enzyme.   "
44587|NCT02702102|"     This study uses a special type of scan called a positron emission tomography (PET) scan to     take pictures of the brain. During the PET scan, a special dye called 11C-PBR28 is injected     into the body.      11C-PBR28 sticks to parts of the brain where there is inflammation. The purpose of this study     is to see if 11C-PBR28 can detect inflammation in patients with Parkinson's disease dementia     or dementia with Lewy bodies.      11C-PBR28 is considered a drug by the Food and Drug Administration. 11C-PBR28 is not a     treatment for any disease. Rather, 11C-PBR28 can be used to measure inflammation in the     brain.   "
44598|NCT02701959|"     Leafy vegetables are a natural source of dietary nitrate, which may reduce systolic blood     pressure (BP). However, the evidence has been obtained from studies using nitrate solutions     (i.e., potassium or sodium nitrate) or beetroot juice supplementation which have a suitable     placebo for the design of double-blind clinical trials. However, the design of food-based     nutritional interventions is complicated by the fact that an appropriate placebo treatment is     not available and, therefore, it is not possible to meet the criteria for proper double-blind     randomised placebo-controlled intervention trials. In addition, the biological effects of     processed products such as beetroot juice or solutions with a pharmacological grade may be     different from that of fresh vegetables, e.g. due to conversion of nitrate to nitrite in the     mouth during chewing.      Objectives: to investigate whether two sets of lettuce specifically grown with different     nitrate content but otherwise similar composition show different effects on nitrate uptake     and bioavailability in humans. Additionally, the investigators also aim to design human     intervention studies to investigate the effect of intake of lettuce with different nitrate     content on vascular health.      These objectives will be tested by growing lettuce with different fertiliser compositions     resulting in high and low nitrate content and then investigating the bioavailability and     short-term effect on BP in healthy young volunteers in a double-blind cross-over design.     Eligible subjects will consume one meal each of either low or high nitrate lettuce. Urine,     blood and saliva samples will be collected at baseline, for 6 hours after the ingestion and     then again after 24hr. Blood Pressure BP will be measured continuously for 24 hours starting     at baseline. The volunteers will repeat the intervention with the second treatment.   "
44588|NCT02702089|"     14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients     represent a rising proportion of these patients. Whilst the gold standard is often to remove     the tumour and restore bowel continuity, surgeons will often avoid this procedure in this     group of patients as they unfortunately tolerate surgical complications very poorly. Such     surgical complications may present with life threatening sepsis, can prolong hospital stay,     delay further cancer therapy and in the elderly or frail patient often leads to loss of     independence and quality of life. In this setting, there are two alternative procedures     (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in     roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is     anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications     (30%) and a few small retrospective studies have shown this (1-3), however there are no     prospective data to support this view. Whilst some surgeons do choose intersphincteric APE     (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived     limitations in the technique (longer operating time, risk of tumour perforation), which are     unproven. We feel that a larger, prospective dataset is required to demonstrate the     superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have     explored the possibility of a full randomised trial to answer this question, however this is     not feasible due to the difficulty of randomisation of patients. Very little data are     available regarding the use of IAPE in the setting of rectal cancer, however many surgeons     who do employ the technique, specifically adapt their technique in this setting to reduce the     chances of tumour perforation (two stage, stapling off rectum before removing anal canal     separately). It is possible that those surgeons who prefer HP have not considered this, and     combined with the lack of prospective data are reluctant to change technique. We are     confident that if we can demonstrate a significant difference in surgical complication rate     and promote a modification to the IAPE surgical technique then we can significantly reduce     surgical harm to these frail patients.   "
44589|NCT02702076|"     This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of     continuous apomorphine infusion compared to placebo in PD patients with visual     hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.   "
44590|NCT02702063|"     Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical     cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output.     However, its accuracy has been inconsistent. Therefore Martin et al. have compared     measurements with echocardiographic measurements and propose calibration with left ventricle     outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This     study was performed in pregnant women at term. Goal of this study is to validate their     formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up.     Secondary aim is to perform a leg raising test and to compare changes in stroke volume     observed with either EC or TTE.   "
44591|NCT02702050|"     The purpose of this study is to investigate the efficacy of mechanical stimulation on     mastectomy scars in:      (i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii)     reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of     life, in women with breast cancer after mastectomy.   "
44629|NCT02701543|"     To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic     or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal     Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.   "
44592|NCT02702037|"     The novelty with the OPEN study is to evaluate the effects of the simple sit-to-stand     exercise during routine care, in combination with an oral protein-rich supplement, on     functional status and independence in frail older persons. In this study we will also explore     the experiences among older persons in the intervention group as wells as among staff of     promoting the sit-to-stand exercise and nutritional supplement to gain knowledge for     implementation as a daily routine in nursing homes across Sweden.      Hypothesis The main hypothesis of the OPEN study is that physical exercise performed as a     daily routine along with an oral protein-rich supplement, will result in improved functional     status and independence in everyday life activities and thereby enhance health-related     quality of life in older persons living in nursing homes. The primary outcome measure for     functional status will be the number of sit-to-stands that the participant is able to     complete in 30 seconds.      Specific aims Aim I: To study the effects of the sit-to-stand exercise combined with an oral     protein-rich supplement on functional and nutritional status, and health-related quality of     life, and the frequency and incidence of falls, pressure ulcers and incontinence in older     persons living in nursing homes. Furthermore, the cost effectiveness of the combination of     the sit to stand exercise and oral protein-rich supplement vs. the control group will also be     examined.      Aim II: To describe the older persons' perceptions of daily being offered to conduct the     sit-to-stand exercise and to drink the nutritional supplement.      Aim III: To describe staff's perceptions of supporting the sit-to-stand exercise and the     nutritional supplement with older persons living in nursing homes.   "
44593|NCT02702024|"     Placenta percreta is a life-threatening condition that patients are under risk of massive     bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean     hysterectomy is the procedure that is acknowledged worldwide, however, recent studies     discussing conservative treatment with segmental resections were published. Fetal extraction     and segmental resection could be performed from same (single uterine incision) or two     different (double uterine incision) incisions. In this study, the investigators aimed to     evaluate the effectiveness and the results of double uterine incision.   "
44594|NCT02702011|"     To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral     doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive     therapy to insulin.   "
44595|NCT02701998|"     This study involves a randomized controlled trial to test the feasibility, acceptability, and     efficacy of a mobile health (mHealth)-enhanced physical activity (PA) intervention to     increase daily bout-related and total moderate-intensity PA and to reduce sedentary behavior     (SB) in non-physically impaired patients with ischemic stroke or transient ischemic attack     (TIA).   "
44596|NCT02701985|"     This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group     study designed to evaluate the effects of RO5459072 treatment on disease activity and     symptoms of Sjogren's syndrome in adult participants with moderate to severe primary     Sjogren's syndrome. The total duration of the study for each participant will be     approximately 18 weeks (including screening).   "
44597|NCT02701972|"     The preclinical and clinical evidence of safety and efficacy with the BACE device (concept     and feasibility) paved the way for the evaluation of the BACE device in this prospective,     multi-center, single-arm, self-controlled study for safety and efficacy in the treatment of     functional MR in a maximum of 60 adult subjects.      The primary efficacy endpoint will be reduction of MR grade to 1+ or less from the baseline     MR grade through the 6 month study period. Primary safety endpoint will be freedom from major     device and surgery-related adverse events for the duration of the 6 month follow up period.     Patients will be followed up to two years.   "
44599|NCT02701946|"     Total knee arthroplasty (TKA) is one of the most successful procedures in orthopaedic     surgery. Nevertheless, significant postoperative blood loss and requirement of blood     transfusion are still problematic. Total blood loss in TKA can be divided into visible and     invisible blood loss. Visible blood loss (VBL) means blood loss from the surgical field and     wound drainage while invisible blood loss (IBL) means residual blood in the knee,     extravasation into the tissues and loss due to haemolysis.      In usual practice, TKA is performed with a bloodless field using a tourniquet. Thus     intraoperative blood loss can be negligible and postoperative drainage is only considered as     VBLvisible. In terms of IBL, Sehat et al. found that TKA carried a substantial IBL. Their     results shown the mean IBL was 765 ml or 49% of the mean total blood loss after TKA.     Therefore, the true total blood loss was underestimated if not takes IBL into account.      Modified Robert Jones bandage (MRJB) is a bulky compressive dressing that often used in     orthopaedic practice. Various techniques of application have been proposed.      From the previous study, MRJB could make and maintain the anterolateral muscle compartment     pressure for at least 24 hours after TKA. Therefore, theoretically, this bandage can cause     the tamponade effect that helps to reduce tissue edema and postoperative bleeding especially     IBL after TKA. However this potential benefit of MRJB is unclear and the use of this bandage     after TKA is still controversy in clinical practice.   "
44600|NCT02701933|"     In this study, the investigators examine the effects of low-dose ketamine on different     oculomotor, perceptual and cognitive functions. They also examine effects on concurrent brain     activity using blood oxygen level dependent (BOLD) functional magnetic resonance imaging     (fMRI). A sample of N=25 healthy, male participants is required to complete the study. The     design is within-subjects, placebo-controlled, double-blind and cross-over. A targeted     ketamine level in plasma of 100ng/ml is applied. It is hypothesised that ketamine, compared     to placebo, will lead to changes in task performance and brain activity similar to those     observed in patients with schizophrenia.   "
44601|NCT02701920|"     This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a     hat with other common forms of heart rate monitoring such as electrocardiography (ECG),     stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new     heart rate sensor's reliability and accuracy.   "
44602|NCT02701907|"     Adult patients with metastatic or locally advanced solid malignancies (including but not     limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer,     ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having     presented an exceptional and unexpected response to an antineoplastic targeted therapy.   "
44603|NCT02701894|"     With the emerging worldwide epidemic of type 2 diabetes, dietary recommendations to improve     diabetes management have been emphasized in the scientific community. Particular attention     has been drawn to various benefits of replacing saturated fatty acids with unsaturated fatty     acids. Alpha-linolenic acid, the only omega-3 fatty acid that is from plant sources, has been     suggested by animal and cell studies to play a beneficial role in regulating blood glucose     levels. However, human studies have been more inconsistent with their findings. The focus of     this project is to investigate the evidence in the context of ALA and blood glucose     parameters in participants with type 2 diabetes by conducting a systematic review and     meta-analysis of randomized controlled trials.   "
44604|NCT02701881|"     -  Prospective, randomized, controlled, multi-center study        -  A total of 220 subjects with long femoropopliteal lesions will be included according to          inclusion and exclusion criteria.        -  Patients will be randomized in a 1:1 manner into long stenting group versus short          stenting group. and treated with Zilver PTX for long femoropopliteal lesions        -  Patients will be followed clinically for 1 year after the procedure.        -  Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.   "
44605|NCT02701868|"     Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants     in the U.S. are fed infant formula. Despite an almost identical energy density between infant     formula and breast milk, formula fed infants experience greater weight gain in the first year     of life. The investigators propose that unintentional overfeeding, of nearly one additional     day of calories per week, due to the over-scooping of powdered formula contributes     significantly to this phenomenon and potentially to the early development of childhood     obesity, a significant public health problem.   "
44606|NCT02701855|"     This study aims to determine the relationships between retina micro-vascular remodeling and     cognitive function in hypertensive patients.      The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and     60 without MCI).   "
44607|NCT02701842|"     The researchers want to find out more about a standalone software application, ImPACT Online     and how it relates to other commonly used tests of memory, attention and reaction time.     ImPACT Online is a computer-based neurocognitive test for concussion management. The test was     designed to help measure the effects of concussion on cognitive processes (for example,     memory, attention, brain speed) and visual functioning.   "
44608|NCT02701829|"     In our past work it was found that many drivers had high blood pressure, and lifestyles that     led to being overweight and not having cancer screenings performed. The investigators are now     adding to the Health Fairs' usual program different ways of following up with drivers who     attend our Health Fairs. The investigators are doing this because they want to find the best     way to help drivers manage high blood pressure, and reduce cancer risk, by maintaining a     healthy weight and increasing colorectal cancer screening.      * If critically abnormal values are identified during the health fair, under the advisement     of the clinician, the driver may be escorted by trained staff directly to a health care     facility for immediate medical follow-up   "
44609|NCT02701816|"     -  Prospective, single-arm, multi-center registry study        -  A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and          exclusion criteria will be included.        -  Patients will be followed clinically for 12 months after the procedure.        -  Duplex ultrasound, CT or catheter-based angiography follow-up according to participating          hospital's protocol will be performed at 12 months.        -  Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12          months.        -  Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)   "
44614|NCT02701738|"     The primary purpose of this study is to examine the effects of 1-week of overeating on     important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile,     and blood pressure) and factors regulating the structure and metabolic function of fat     tissue. This study will determine how regular exercise during this overeating period impacts     these responses.   "
44615|NCT02701725|"     The investigators will use the Compensatory Reserve Index (CRI) device to monitor hemodynamic     status of patients in the hospital. CRI values of patients will be monitored during their     care in order to verify the compliance of the values to the physiological condition. During     the protocol investigators will document patients injuries, life-saving procedures performed,     response to treatment as well progress to systemic inflammatory response syndrome (SIRS) and     sepsis.      The indices measured in the study will not be a consideration when handling patients. The     medical team will not be exposed to metrics measured.   "
44616|NCT02701712|"     The aim of this study is to evaluate the technical performance of magnetic-resonance guided     radiotherapy (MRgRT) facility at the Princess Margaret Cancer Centre and the impact on the     workflow of the clinical team in this facility.   "
44617|NCT02701699|"     The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using     a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and     responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure     hypoxia may be better and simpler than the approaches used previously. This study will assess     whether or not PET scans can provide useful information about hypoxia in lung cancer.      In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to measure     hypoxia in the patient's tumour. FAZA has already been used in many cancers including lung     cancer. Patients who consent to participate in this trial will receive 1 FAZA PET Scan prior     to their first radiotherapy treatment   "
44618|NCT02701686|"     The purpose of this study is to test the effectiveness of negotiating self determination to     reduce cigarette consumption. A single-blinded multi-centre randomized controlled is     employed.   "
44619|NCT02701673|"     The goal of this clinical research study is to find the highest tolerable dose of belinostat     that can be given in combination with azacitidine, gemcitabine, busulfan, and melphalan to     patients who are scheduled to have a stem cell transplant. If you have diffuse large B-cell     lymphoma (DLBCL), you will also receive rituximab. Researchers also want to learn about the     safety and effectiveness of this combination.   "
44648|NCT02701296|"     To assess pain control after total knee replacement surgery using two different nerve block     techniques. The 2 methods are:        1. Continuous femoral nerve block with ultrasound guided posterior capsular injection        2. Continuous femoral nerve block with ultrasound selective tibial nerve block.   "
44620|NCT02701660|"     Electronic dispensers for polypharmacy are used in home care to assist patients with their     medication management and to improve adherence. Opioid dependent patients with substitution     therapy often exhibit multiple risk factors for non-adherence. The increase of both the age     and associated comorbidities in this population demand for innovative solutions to optimize     medication management. The investigators developed a novel medication supply model with an     automated electronic medication dispenser to simultaneously assist opioid dependent patients     with their medication and objectively monitor their adherence. This study aims to demonstrate     the feasibility of the new supply model.   "
44621|NCT02701647|"     The Purpose of this study is to investigate whether the beneficial effect of treadmill     training on people with Parkinson's disease can be enhanced by repetitive transcranial     magnetic stimulation (rTMS).   "
44622|NCT02701634|"     This study will evaluate the effect of entospletinib on the best overall response rate in     adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic     corticosteroids as first-line therapy for cGVHD.   "
44623|NCT02701621|"     The aim of this study is to compare the effectiveness of a specific aquatic therapy program     on balance with a land-based physical-treatment in patients with Parkinson's disease and to     evaluate the long-term effects in a 6-month follow-up period.   "
44624|NCT02701608|"     Infective endocarditis (IE) is a serious infection with a significant burden for patients and     hospitals (in France, median length of hospital stay = 43 days), partly due to the long     duration of intravenous (IV) antibacterial treatment recommended by international guidelines,     between 4 and 6 weeks in most situations.      A recent survey of practices regarding the management of IE in France showed that a switch     from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are     stable after an initial course of IV antibiotic treatment, with or without valvular surgery.      These practices have not been associated with unfavourable outcome, while significantly     reducing the duration and cost of hospitalization, the risk of nosocomial infection, and     patients' discomfort.      There has been no randomized controlled trial (RCT) in the field of IE over the last 20     years; current guidelines are mostly based on expert advice, in vitro studies, animal     experiments, or clinical studies performed before the 90's.      The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in     the field of IE.      Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such     as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when     orally administrated after an IV period of induction.      It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this     strategy for multisusceptible staphylococci with a benefit regarding costs.      The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch     strategy, making it a comparative effectiveness trial that should be able to feed the next     revision of IE international guidelines and to change practices in IE management.   "
44634|NCT02701478|"     N2O has been used during general anesthesia (GA) for more than 100 years. It is known to have     anesthetic agents sparing effect. But small is know on his real analgesic effect during GA.     So far, the only way to monitor pain during GA was based on vital signs that are not specific     and not sensitive. Few devices tried to evaluated pain under GA during the last 2 decades.     More recently, better devices were proposed such as the Physiodoloris device and the PMD200     device. The first offers an index called ANI based on heart rate variability (HRV)     assessment. The second offers the NoL index based on the analysis of 5 parameters. The aim of     the present study is to evaluate quantitatively the analgesic index of N2O during GA using     the two indices ANI and NoL.   "
44635|NCT02701465|"     The purpose of this randomized clinical trial is two-fold. Firstly to see if patients     suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in     their shoulder, and secondly to investigate how changes in this blood flow are related to     pain experience and shoulder function.   "
44625|NCT02701595|"     Infective endocarditis (IE) is a serious infection with a significant burden for patients and     hospitals (in France, median length of hospital stay = 43 days), partly due to the long     duration of intravenous (IV) antibacterial treatment recommended by international guidelines,     between 4 and 6 weeks in most situations.      A recent survey of practices regarding the management of IE in France showed that a switch     from IV to oral antibiotics is feasible, when patients with left-sided     Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment,     with or without valvular surgery.      These practices have not been associated with unfavourable outcome, while significantly     reducing the duration and cost of hospitalization, the risk of nosocomial infection, and     patients' discomfort.      There has been no randomized controlled trial (RCT) in the field of IE over the last 20     years; current guidelines are mostly based on expert advice, in vitro studies, animal     experiments, or clinical studies performed before the 90's.      The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in     the field of IE.      Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such     as amoxicillin allow a high level of efficacy in the treatment of IE when orally     administrated after an IV period of induction.      It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this     strategy for streptococci, and enterococci IE with a benefit regarding costs.      The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch     strategy, making it a comparative effectiveness trial that should be able to feed the next     revision of IE international guidelines and to change practices in IE management.   "
44626|NCT02701582|"     This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000     system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor     resection complicated by cerebral edema, or complex spinal surgery including multi-level     scoliosis correction, is a more effective way of monitoring fluid.   "
44627|NCT02701569|"     The purpose of this study was to investigate the effect of rebound exercise (mini trampoline     jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.   "
44628|NCT02701556|"     The objective of this study is to evaluate the safety and effectiveness of NNR06     Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE     Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual     contact lens wearers to bilaterally clean and disinfect their contact lenses for     approximately three months.   "
44630|NCT02701530|"     The aim of this trial is to develop a new tailored smoking cessation program for smokers with     low education. Smokers are involved in design of the intervention. The effect of the     intervention is then tested in a randomised controlled trial. Half of workplaces will be     offered the intervention and the other half will be control group, not receiving any offer.   "
44631|NCT02701517|"     The primary aim of the study was to compare the efficacy of the procedure in terms of     event-free survival between patients receiving cyclosporine (CsA) plus either alemtuzumab     (CAMPATH-1H ) or methotrexate (MTX) after matched related donor allo-reduced intensity     conditioning. Secondary aims were: 1. To compare the incidence of infections and     transplant-related mortality between the two arms; 2. to compare the incidence of acute and     chronic GVHD 3. to evaluate hematologic and immunologic reconstitution and evolution of     chimerism and residual disease.      Patients were randomly assigned to received cyclosporine plus alemtuzumab or cyclosporine     plus MTX and were stratified according to diagnosis: Chronic lymphocytic leukemia or Low     grade- non-Hodgkin's lymphoma.      All patients received the same reduced-intensity conditioning (RIC) scheme based on     fludarabine 150mg/m2 (30 mg/m2/day everyday from -8 to -4) plus melphalan 140mg/m2 (70     mg/m2/day everyday from -3 to -2). Regarding the GVHD prophylaxis, patients in group 1 (n=17)     received CsA 1 mg/kg intravenously starting on day -7 and 2/mg/Kg from day -1 plus     alemtuzumab administered at a dose of 20 mg IV on -8 to -4 whereas in group 2 (n=23) pts     received CsA at same doses as group 1 plus MTX given at a dose of 15 mg/m2 intravenously on     days 1 and 10 mg/m2 on days 3, 6 and 11, followed by folinic acid rescue (15 mg in +1 and 10     mg in +3, +6 and +11 intravenously every 6 hours for 4 doses starting 24 hours after each     dose of MTX).      Acute and chronic GVHD were similarly graded by established criteria [20, 21]. In patients     receiving alemtuzumab, CsA was suspended by day +130. They also received donor lymphocyte     infusion (DLI) at a dose of 1 x 107 cluster of differentiation 3 / kg on day +180 in case of     active disease, persistence of minimal residual disease detected by flow cytometry or mixed     chimerism and no GVHD. In case mixed chimerism, donor lymphocyte infusion was performed if     patient hematopoiesis progressively increased. In patients receiving CsA + MTX, CsA was     suspended by day +180. These patients received DLI only in situations specified above.      The statistical analysis has been designed to identify a 20% difference in terms of     disease-free survival (based on the increased incidence of relapse in patients receiving     T-cell depletion).   "
44632|NCT02701504|"     Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous     studies suggested sleep apnea was associated with coronary plaque burden and future adverse     cardiovascular events. Sleep apnea is also associated with a high incidence of atrial     fibrillation in patients undergoing coronary artery bypass grafting. Yet, previous reports     used Berlin Questionnaire and Epworth Sleepiness Scale Questionnaire to diagnose sleep apnea.     However, these screening questionnaires are not as accurate as a proper sleep study. In the     SABOT study, the investigators used the portable sleep device to diagnose sleep apnea, and     evaluate the relationship between sleep apnea and cardiovascular outcomes after coronary     artery bypass surgery.   "
44633|NCT02701491|"     The acute gastroenteritis is a very common problem in children. The frequency and duration of     this condition involves a high discomfort for the child and his family, and significant     costs, in connection with the purchase of therapeutic aids, medical visits, days of work lost     by parents, requiring hospitalization. Vomiting is a typical symptom of the majority of the     cases of acute gastroenteritis and is very often the cause of failure of oral rehydration use     and hospitalization.      To limit vomiting and facilitate oral rehydration have been proposed several pharmacological     strategies. Unfortunately, these therapies are unsuccessful (domperidone), expensive and side     effects (ondansetron and metoclopramide) and therefore contraindicated in patients of     pediatric age.      The administration of some medicinal herbs is able to induce an effective anti-emetic power.     Among the various types of plants studied, the rhizome of Zingiber officinale, commonly known     as ginger is used as an antiemetic in various traditional systems of medicine for over 2000     years. There are several scientific evidence on the beneficial properties of ginger,     including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . It was also     demonstrated that ginger is effective in resolving the post-operative nausea and vomiting and     in pregnant. A recent meta-analysis has confirmed that ginger is effective in     non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy.      To date there are several formulations of the ginger on the market in Italy, and their use is     fairly widespread in children for the treatment of vomiting by acute gastroenteritis in the     absence of clinical evidence of efficacy.      The purpose of the proposed study is to demonstrate the effectiveness of treatment with     ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.   "
44833|NCT02698878|"     The present study aimed to investigate whether a daily intake of lupin protein and a     neuromuscular electrical stimulation training twice a day can improve local glucose uptake     into m. soleus during a 60 day unloading phase with a special unloading device, the     HEPHAISTOS orthosis (HEP).   "
44636|NCT02701452|"     In the literature, the risk of moderate to severe OHSS is 3 to 6% and reaches 31% in high     risk populations 9 days after oocyte triggering with hCG. Many studies report no or a     markedly decreased risk of OHSS after triggering ovulation with a GnRH agonist. However,     criteria to define OHSS are rarely explained and OHSS itself is not thoroughly asserted. It     is well known that OHSS is associated with hypercoagulability. However, no study after     triggering with a GnRH agonist assessed haemostasis in these high-risk patients with high     circulating estradiol levels.      Study design, size, duration: In a French academic reproductive medicine centre, a systematic     prospective observational follow-up of all patients triggered by GnRH agonist for excessive     follicular response will be conducted. Participants/materials, setting, methods: All patients     undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or     more than 20 follicles ≥ 11mm on the day of triggering) will be triggered by GnRH agonist. No     luteal phase support and a freeze-all strategy will be performed. On the day of oocyte     retrieval (T0), at 48h (T1) and at day 7 (T2), OHSS and hypercoagulability will be     systematically assessed. Haemostasis data will be compared to the initial status of each     patient.   "
44637|NCT02701439|"     This study is investigating a better method to see if someone has tuberculosis (TB) as     compared to the method that is being used now.   "
44638|NCT02701426|"     Background:      Obesity increasingly affects young women and contributes to increased maternal, fetal and     neonatal complications. Maternal obesity contributes to the subsequent development of     childhood obesity not only through social and environmental mechanisms but also through     biological processes referring to the original concept of the developmental health and     disease. Data suggest that management during pregnancy through nutrition counseling and     adequate physical activity will help to break the familial vicious circle of obesity. To help     program to be effective it is important to understand the factors that modulate     participation. However, few studies have been conducted to assess the determinants that     influence participation.      Goal:      The main objective is to analyze 15 factors that influence participation in a program     combining physical activity and nutritional counseling among pregnant women with BMI ≥ 25     kg/m2. Secondary objectives are :        -  to identify the data that influence adherence and to show that assiduous women will have          a better control of weight gain and a reduction of maternal and fetal complications.        -  to understand the biological mechanisms involved      Strategy and method:      A prospective research evaluating the participation in an educational program, including     nutritional support and adequate physical activity, will be offered to overweight and obese     pregnant women. The program will last 12 weeks, and will include three workshops on diet of     the pregnant and lactating women, and the young child. Physical activity sessions will be     offered once a week. Fifteen independent variables likely to influence participation will be     analyzed. The association between participation and the risk of maternal and fetal pregnancy     complications related to obesity will be analysed. Meanwhile, more fundamental research will     be considered to determine of the biological factors involved.   "
44649|NCT02701283|"     The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR     system as measured by rates of all-cause mortality or disabling stroke at two years is     noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low     predicted risk of operative mortality for SAVR.   "
44639|NCT02701413|"     For too many women, childbirth results in devastating consequences: involuntary loss of feces     or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe     tears during childbirth may develop these problems. These new mothers avoid leaving home in     order to stay close to a toilet, wear protective pads every day, and avoid activities they     previously enjoyed such as exercise and sexual intercourse. It is not surprising that many of     these women suffer from postpartum depression, and bonding with their newborns is     compromised.      Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during     childbirth. Many researchers have focused on what can be done to prevent these injuries;     however, few have investigated how to help the countless women who have already suffered from     these injuries to the nerves and muscles. In other fields such as orthopedics and neurology,     research shows that electrical stimulation can provoke nerve regeneration after injury.     Applying this technology to women who have recently suffered from nerve injury during     childbirth could have profound and life-changing effects. Investigators hypothesize that     electrical stimulation immediately postpartum will markedly help pelvic nerves regenerate,     minimizing rates of fecal and urinary incontinence for this vulnerable population of new     mothers.   "
44640|NCT02701400|"     This randomized clinical trial studies how well tremelimumab and durvalumab with or without     radiation therapy works in treating patients with small cell lung cancer that has returned     after a period of improvement. Monoclonal antibodies, such as tremelimumab and durvalumab,     may limit the ability of tumor cells to grow and spread by enhancing immune function.     Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving     tremelimumab and durvalumab together with radiation therapy may lead to improved clinical     benefit.   "
44641|NCT02701387|"     The purpose of this study is to determine whether implant thread design impacts bone     remodeling and/or dental implant stability in the early healing period.      The population of this study will consist of a group of subjects who are interested in     replacing two or more missing teeth with dental implants. All implant sites will be healed     and not require bone augmentation for the placement of a standard 4 mm diameter implant.     Subjects first will undergo a brief screening exam. If accepted, comprehensive oral exam will     be completed. Subsequently, enrolled subjects will be scheduled for dental surgery to place     the implant(s). Subjects will return weekly for the first 8 weeks after placement for a brief     post-operative appointment in order to conduct measurements for the study.   "
44642|NCT02701374|"     In Post-Herpetic Neuralgia(PHN) patients:        -  To conduct an explorative investigation of the efficacy and safety of repeated oral          doses of TRK-700 via a randomized double blind comparative study        -  To measure the plasma concentration of TRK-700 and its metabolites   "
44643|NCT02701361|"     Many survivors of the intensive care unit (ICU) suffer from persistent symptoms of     depression, anxiety, and post-traumatic stress disorder (PTSD). In this study, the     investigators will test the impact of mindfulness to address this distress.   "
44644|NCT02701348|"     The purpose of this study is to monitor the change in cancer size in women with breast cancer     on anti-hormone treatment using different types of assessment including ultrasound scan (US),     shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this     corresponds to the changes in the cancer biology.   "
44656|NCT02701192|"     The purpose of the study is to analyze the outcomes of patients with coccygodynia (pain in     and around the coccyx region) treated with coccygectomy (a procedure during which the coccyx     is removed) and to report on the rate of complications of the procedure. The study will also     aim to find pre-operative clinical predictors of good outcomes after coccygectomy. The     investigators hypothesize that coccygectomy will not improve scores on the Short Form-36     (SF-36), Oswestry Disability Scale (ODI), tolerable sitting time, or Visual Analog Pain Scale     (VAS). Also, the investigators hypothesize that there are no independent variables associated     with improved outcomes.   "
44645|NCT02701335|"     Osteoarthritis (OA) of the hand is a major cause of pain and functional limitation, central     sensitization of pain can be one of the causes: this hypothesis opens avenues for research in     the modulation of pain pathways. The peripherally directed therapies may modulate pain     perception bilaterally. This hypothesis opens avenues for future research in the modulation     of pain pathways, perhaps offering targets to optimize peripheral manual and physical     therapies for pain management in hand OA.      Several studies have reported the outcomes of multimodal approach to central sensitization     evaluated by generalized pressure pain hypersensitivity in patients with carpometacarpal     (CMC) OA. Neurodynamic techniques are a form of manual therapy directed to the neural     structures through positioning and movement of multiple joints. Recent technologies have     facilitated the use of robots as tools to assist patients in the rehabilitation process thus     maximizing patient outcomes. These robotic tools assist the patient with carrying out     exercise protocols, optimal for the activity of the control group.   "
44646|NCT02701322|"     The purpose of this study is to determine whether a participation of a medical clown in     videofluoroscopic examination of pediatric speech disorder such as velopharyngeal inadequacy,     improves the collaboration of the pediatric patient, the patient's and the caregivers     subjective experience, and the quality of the examination (shorter exposure to radiation,     shorter time at the radiology suite, more accurate parameters retrieved from the imaging     results).   "
44647|NCT02701309|"     This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence     non-invasively from the intact oral mucosa in children. The prototype device has shown high     sensitivity and specificity in women after delivery for iron deficiency. Children are at     increased risk for iron deficiency and prevention methods are not established jet. Zinc     protoporphyrin-IX is an early indicator of iron deficiency and may be more sensitive than     other established parameters. The prototype device is used to measure the erythrocyte zinc     protoporphyrin-IX/heme ratio in children aged 9 months to 5 years. Children in this age are     at increased risk for iron deficiency as they are growing rapidly and iron deficiency in this     age may affect the neurodevelopment and immune system adversely. It is proposed that these     effects cannot be rectified by iron supplementation in later years. The results from the     non-invasive measurements are compared to reference measurements of the erythrocyte zinc     protoporphyrin-IX/heme ratio from residual blood samples from the same patients and to other     indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin,     transferrin saturation and soluble transferrin receptor.   "
44651|NCT02701257|"     This study will compare two different models of a wearable bionic pancreas device (the     iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1     diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then     give insulin and/or glucagon automatically to regulate the blood glucose (BG).   "
44652|NCT02701244|"     For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a     common treatment option. Radiation treatment is typically delivered to the whole breast, five     times per week, for anywhere from 3 to 8 weeks. The radiation helps kill any cancer cells     that may have been left over following the surgery but causes skin burns. Many studies have     demonstrated that radiation to the whole breast is not necessary, that it can be delivered to     a portion of the breast where the cancer is more likely to recur.      A technique called a Permanent Breast Seed Implant (PBSI) involving the implantation of     radioactive seeds has been developed to deliver the radiation to a portion of the breast. The     procedure is performed on an out-patient basis under local anesthesia and light sedation.     Because the radioactive seeds are permanently implanted in the breast, the patient is able to     live a normal life while the seeds deliver the prescribed radiation to the breast.      Previous studies on PBSI demonstrate that it is a safe and effective alternative form of     radiation for appropriately selected patients after lumpectomy. However, those results have     been obtained mainly from a single institution, with only 4 patients treated in another     center. Further research is still needed to evaluate its safety in a multi-center setting.     The purpose of this study is to ensure the appropriate training of clinicians who will be     performing this procedure and to capture long term outcomes and rare complications if any.   "
44653|NCT02701231|"     The purpose of this study is to determine whether Low-frequency Rotating Magnetic Therapy     System is effective and safe in the treatment of advanced lung cancer.   "
44654|NCT02701218|"     Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be     randomized to treat with single or multiple cycles of canalith repositioning procedure.The     treatment outcomes will be assessed at 7th and 28th days.   "
44655|NCT02701205|"     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy     and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in     the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the     different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke®.     And the second purpose is to assess the efficacy and safety of Qiangke® in Moderate to Severe     Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and     at the first stage they will be randomized divided into three group: full-dose of Qiangke®     group, half-dose of Qiangke® group and placebo group.And the blind stage will last for 12     weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke® for additional     12 weeks.   "
44887|NCT02698124|"     Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects     will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive     and not candidate for intensive induction chemotherapy (iIC)   "
44657|NCT02701179|"     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various     bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often     reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be     significantly improved with control of cough. Use of sedation during bronchoscopy has been     reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is     routinely performed at many centres including ours.      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is     limited literature on the efficacy of lower concentrations (1%) versus a higher (2%) during     bronchoscopic procedures. This study would help to determine whether 1% lignocaine is as     effective as 2% lignocaine for airway anaesthesia during flexible bronchoscopy.   "
44658|NCT02701166|"     Randomized double blind placebo controlled trial to evaluate the antipruritic effect of     bezafibrate in patients with moderate to severe cholestatic itch.   "
44659|NCT02701153|"     This phase II trial studies the side effects of hypofractionated radiation therapy in     treating patients with soft tissue sarcomas that have come back before surgery.     Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter     period of time and may kill more tumor cells and have fewer side effects.   "
44660|NCT02701140|"     The aim of this study is to assess the pleiotropic effects of ticagrelor that could represent     possible mechanisms for its beneficial effects on cardiovascular mortality. We will test     three different hypotheses:        1. Ticagrelor may increase ischemic preconditioning as compared to clopidogrel in patients          with stable coronary disease, showing multivessel coronary artery disease and undergoing          staged PCI.        2. Ticagrelor may improve microvascular perfusion in the myocardium of patients with          multivessel coronary artery disease undergoing staged PCI.        3. Ticagrelor may exert positive effects enhancing the paracrine modulation, migration,          homing and survival of hBMDSC, with a potential impact on the microvascular dysfunction          and on the protective response to ischemia (cellular preconditioning).   "
44661|NCT02701127|"     This is a single center, randomized, single-blind, placebo-controlled study to evaluate the     safety and biochemical effects of niacinamide on metabolic parameters of the kidney in     patients undergoing cardiac surgery.   "
44662|NCT02701114|"     This study is designed to evaluate pain control of continuous adductor canal blocks placed     proximally versus distally within the canal. The investigators hypothesize that there will be     similar pain control between both groups.   "
44663|NCT02701101|"     This is a multi-site, longitudinal study to evaluate the use of the SEM Scanner as an adjunct     to clinical judgment for detection of early pressure ulcers in patients before skin     assessments.   "
44695|NCT02700685|"     This double blind, randomised controlled trial examines the effect of a commercially     available nutritional supplement on behaviour of ADHD patients, as well as on their physical     and psychiatric co-morbidities, and level of oxidative stress and immune activity, as     compared to placebo and standard pharmaceutical treatment for ADHD.   "
44696|NCT02700672|"     The study analyses if cognition and gait speed can predict falls in a community-dwelling     people and ambulant long term care residents   "
44664|NCT02701088|"     Anal canal carcinoma (ACC) represents 1.2% of digestive cancers. Its incidence is increasing.     As epidermoid ACC (95% of ACC) are particularly sensitive to radio and chemotherapy,     concomitant radio-chemotherapy is the standard treatment of locally advanced ACC, with proven     efficacy on locoregional control, anal sphincter preservation, progression-free survival and     complete response rate higher than 80%.      Nevertheless, conventional radiotherapy frequently induces significant non-haematological     toxicities requiring treatment interruptions. Thus, treatment usually includes a chemotherapy     (5-Fluorouracil and Mitomycine-C) and 25 fractions of 1.8 Gy followed by a planned 1-week (or     more) interruption and a boost, for a total 54-60 Gy radiation dose over 9 weeks.      Considering the numerous anatomic pelvic structures, ACC has become a localisation of     interest for Intensity-Modulated Radiation Therapy (IMRT) associated with less toxicity.      However, IMRT induces grade≥3 cutaneous toxicities requiring irradiation breaks. Dose     escalade did not show its interest: 60 Grays remains the standard.      Assuming the deleterious effect of increased overall treatment time on local control and     survival in head-and-neck and cervical cancers and the epidermoid histology of ACC, the     benefit of no irradiation break on ACC tumour control is of interest.      IMRT offers the possibility to deliver different doses to different target volumes     simultaneously by altered fractionation schedule like SIB-IMRT (simultaneously integrated     boost-IMRT). Several SIB-IMRT schedules have been retrospectively evaluated. Similar results     were observed with moderate doses and schedules delivering higher doses with short     interruptions. Nevertheless, standard SIB-IMRT schedule in ACC still not exist.   "
44665|NCT02701075|"     The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that     interferes with pain signal transmission by using nerve fibers as a passive means to convey a     message of normality (sans pain) to the central nervous system. While preliminary research     has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and     failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain     secondary to traumatic musculoskeletal injuries like those experienced in combat has not been     investigated. The purpose of this prospective, double-blind, randomized controlled, study is     to determine if the MC5-A ST is efficacious in altering the biological, psychological, and     social components of the chronic neuropathic pain experience in military Service Members     (SMs) with traumatic musculoskeletal extremity injuries.   "
44666|NCT02701062|"     Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 2 and     HASBLED of => 2 and will undergo a valve or CABG (structural heart) procedure with direct     visual access to the LAA will be eligible to participate based upon the inclusion and     exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 40     sites and will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who not     develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety.     Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index     procedure.   "
44677|NCT02700919|"     The purpose of this study is to compare the efficacy and safety of BCT197 when added on to     standard of care in adult subjects with acute respiratory exacerbations of chronic     obstructive pulmonary disease requiring hospitalization. Additionally, the study will     characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the     study will be 26 weeks. Subjects will receive study treatment administration over a period of     5 days after randomization. It is expected that approximately 255 subjects will complete the     study and follow-up.   "
44678|NCT02700906|"     The investigators hypothesized that lidocain injection is as effective as corticosteroid     injection in management of tennis elbow, and if so, it may replace corticosteroid injection     in the management of tennis elbow.   "
44667|NCT02701049|"     This trial is the final phase of a three phase PCORI-funded study to develop and test     patient-centered approaches to collect sexual orientation and gender identity (SO/GI)     information in the ED. From the results of Phase 1 qualitative interviews and national     quantitative survey and Phase 2 Delphi rounds with the Stakeholder Advisory Board, we have     determined two methods of collection favored by patients and providers to implement in the     trial. The first method, nurse verbal collection, is in alignment with Partners recommended     clinical practice and is therefore a quality improvement (QI) evaluation. The second method,     non-verbal registrar form collection with nurse verbal confirmation, is a research     intervention to evaluate and compare a new patient-centered approach to SO/GI collection. To     compare the patient-centeredness of the two different approaches, satisfaction surveys will     be administered to ED patients and staff members involved in collection.      In summary, the study design (1) evaluates recommended current practice (QI), (2) evaluates a     quality improvement project to increase recommended current practice, and (3) evaluates a new     method of collecting SO/GI (research intervention).   "
44668|NCT02701036|"     The key goals of SPORTAX-NHS is to compare the phenotype of multiple system atrophy of     cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) and to     determine the rate of disease progression in both groups including determination of the     factors that predict the development of MSA-C vs. SAOA, and at which time after onset of     ataxia, a reliable distinction between both disorders is possible.      The planned study will also allow to collect blood samples and other biomaterials from     patients with sporadic ataxia, which will be useful for future genetic and biomarker studies.   "
44669|NCT02701023|"     The aim of this study is to evaluate the feasibility, safety, and efficacy of MitoGel in the     treatment of UTUC in a human subject with low-grade UTUC which is endoscopically unresectable     or rapidly recurring, and in whom nephrectomy would likely result in the need for permanent     hemodialysis. The study drug would be obtained under the single patient access program     approved by the FDA. The patient would then undergo instillation of MitoGel into the affected     kidney. The catheter would be left indwelling in the ureter and would be externalized. The     ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments,     which would occur twice weekly for 3 weeks or once weekly for 6 weeks. Following the final     instillation, the catheters would be removed. The patient would then undergo ureteroscopic     evaluation at 3 months following the final instillation of MitoGel. The total duration of     study would be 3 months. The total number of study patients is 1.   "
45225|NCT02693678|"     Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint .     The study aim is to assess the effect of manual massage, diathermy and sham diathermy the     proprioception of the knee joint in patients affected by DOMS.   "
44670|NCT02701010|"     Researchers aimed to identify the effectiveness of three methods of patient education for     behavioral therapy (BT), including verbal instructions combined with a leaflet on a     structured training program of BT, only verbal instructions on a structured training and only     a leaflet on a structured BT training. Therefore, a randomized controlled trial was designed     to compare effectiveness of those methods of patient education in BT based on the two     validated patient- reported outcome measures (PROMs) for women with overactive bladder.      Idiopathic overactive bladder (iOAB) symptoms in female patients are perceived as normal,     which does not threaten life and not require to be treated immediately. It is necessary to     raise the awareness of iOAB on women. The education and consultancy role of continence nurses     is important in the treatment and care of urinary incontinence (UI) associated with iOAB. In     the study, it was seen that the training to be provided to patients is helpful regardless of     the teaching method used. Also it was found that the method of verbal instructions in the     form of a structured training plus giving a leaflet to patient is the most effective method     of BT for female iOAB.   "
44671|NCT02700997|"     This study seeks to gain a more thorough understanding of the postoperative location of the     sutures placed during uterosacral ligament suspension. Characterization of the surrounding     anatomy in a living model will enhance surgical technique by delineating safer suture     locations and decrease the incidence of morbid complications for patients.   "
44672|NCT02700984|"     The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in     subjects who completed Study Protocol TMI-09-01, COMPASS Trial.   "
44673|NCT02700971|"     This trial will utilize a Molecular MicroscopeTM diagnostic system (MMDxTM) that combines the     molecular and histopathological features of biopsies, plus clinical and laboratory     parameters, to create the first Integrated Diagnostic System. This MMDxTM will be utilized to     phenotype cutaneous melanoma biopsy samples to detect an immune responsive mRNA signature.   "
44674|NCT02700958|"     Contrast-induced nephropathy (CIN) has remained significant and severe complication of     angiographic procedures despite the increasing use of preventative methods. It has been     associated with prolonged hospital stay, high morality and the need for dialysis. Since     classically used creatinine for diagnosing of CIN does not reflect the degree of tubular     injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers and     preventative methods are needed. Remote ischemic preconditioning is a non-invasive and safe     method which in some studies has been reported to protect against contrast-induced     nephropathy. The purpose of this study is to evaluate the effect of remote ischemic     preconditioning (RIPC) (1) as an additional method to standard treatment to prevent     subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect on     functional properties of arterial wall, organ damage biomarkers and low molecular weight     metabolites.   "
44675|NCT02700945|"     The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF)     through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™     Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC)     medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known     origin.   "
44676|NCT02700932|"     This is an open-label, multi-center study. Subjects in this study will receive up to eight     (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064     nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects     will return for one follow‐up (FU) visit at the clinic at 8 weeks following the last     treatment.      Methodology described in the protocol to evaluate efficacy and safety of treatments will be     carried out at each visit at the clinic   "
44785|NCT02699515|"     The main purpose of this study is assess the safety and tolerability of MSB0011359C. Study     consists of dose-escalation part and an expansion part in subjects with metastatic or locally     advanced solid tumors, for which no standard effective therapy exists or a standard therapy     has failed.   "
44679|NCT02700893|"     Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier:     NCT01490580) which is a multicenter double blind randomized controlled trial comparing     atropine+propofol vs atropine+atracurium+sufentanil as a premedication prior to     endotracheal intubation of the neonate.      Primary outcome:        -  Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before          premedication).        -  Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during          premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 -          rScO2/SaO2 .      Hypothesis: atropine + propofol compared to atropine+atracurium+sufentanil does not     increase the frequency of cerebral hypoxemia.   "
44680|NCT02700880|"     The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure     (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed     ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to     prospectively document the clinical course of high-risk cardiac patients with heart failure     and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such     as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator     (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart     transplantation, and to assess the benefit of WCD in heart failure patients with ischemic     cardiomyopathy.   "
44681|NCT02700867|"     The investigators sought to compare the intraosseous access success rates of the proximal     tibia and the proximal humerus using new Intraosseous access device NIO in an adult cadaver     model during simulated resuscitation.   "
44682|NCT02700854|"     This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of     low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled,     mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that     hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is     deleterious to the injured brain and can be safely avoided with low concentration CO2     inhalation.   "
44697|NCT02700659|"     The aim of this trial is to determine the performance characteristics of the Cxbladder test     for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of     urinary tract UC, who have been treated according to standard practice and are undergoing     routine investigative cystoscopy.      The gold standard for determination of clinical truth is cystoscopy, plus any follow up     investigations relating to the current visit.   "
44683|NCT02700841|"     This pilot, randomized phase II trial studies how well depleted immune suppressor stem cell     transplant works compared to standard stem cell transplant in enhancing immune response to     vaccines in patients with multiple myeloma (MM). Chemotherapy and the patient's own stem     cells are effective in treating MM, however there is a risk of disease returning due to poor     recovery of the immune system as shown to poor response to vaccines to prevent infections.     Before chemotherapy, patients' stem cells are collected and certain immune cells called     suppressor cells are removed from the stem cells. Patients then receive chemotherapy to kill     cancer cells and after that the immune depleted stem cells are returned to them to replace     the blood-forming cells that were destroyed by chemotherapy. Giving depleted immune     suppressor stem cells transplant to patients with MM may result in a more robust immune     response to vaccines after transplant and may prevent MM from returning. It is not yet known     whether depleted immune suppressor stem cell transplant is more effective than standard stem     cell transplant in enhancing immune response to vaccines in patients with multiple myeloma.   "
44684|NCT02700828|"     This is a prospective, randomized, double-blind, placebo controlled, single center study to     compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia     treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms     (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed.      The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency     that may contribute to hypotension and lower efficacy of inotropic therapy in this patient     population. Thus, the investigators are planning to measure initial serum cortisol levels and     investigate the cardiovascular effects of low dose hydrocortisone supplementation besides     conventional inotropic therapy in a placebo-controlled fashion.   "
44685|NCT02700815|"     This randomised, controlled multi-centre parallel group trial will assess the efficacy and     tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in     comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of     acute back pain or neck pain   "
44686|NCT02700802|"     The Feed1st proposed program of research will promote health of informal caregivers with a     hospitalized child by testing a self-management intervention that addresses the widely     overlooked problem of caregiver hunger. As many as 54% of parents and other informal     caregivers of hospitalized children struggle with insufficient food to nourish themselves and     their family during and after a hospital stay. Hunger impairs caregiver physical and mental     health by depleting energy for self-care, emotional self-regulation, and supportive     interactions with the child, the family, and the formal caregiver team. The long-term     objective of the Feed1st program is to alleviate hunger and food insecurity among families     with hospitalized children. Established in partnership with nursing and chaplaincy leadership     at our children's hospital and the Greater Chicago Food Depository, the Feed1st program     currently operates self-serve food pantries on four inpatient units and the emergency     department in our children's hospital on Chicago's South Side. Since 2010, Feed1st has     provided nearly 8500 pounds of food to at least 4,000 individuals and 1500 households via the     self-serve food pantries in the children's hospital. Over this same period, our team has also     created a system for efficiently connecting families to community-based resources for hunger     and other basic needs.   "
44687|NCT02700789|"     Study to determine the diagnostic accuracy of the double decidual sac sign to predict an     intrauterine pregnancy prior to ultrasonographic visualisation of embryonic contents using     modern ultrasound technology.   "
44688|NCT02700776|"     The purpose of this study is find out if a protein level in the blood (called PC Cell Derived     Growth Factor or glycoprotein 88 [GP88]), combined with standard mammography screening, can     help detect breast cancer better than mammography screening alone. Earlier research has shown     that a certain glycoprotein 88 (GP88) is higher in women with breast cancer.      In this study, investigators will measure the level of GP88 in the blood of healthy women who     are having mammography screening for breast cancer. The investigator plans to correlate the     results of the mammogram with the GP-88 level.   "
44786|NCT02699502|"     Metabolic therapy in patients with osteoporosis after hip fracture by cooperation     orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching     the follow-up clinic   "
44689|NCT02700763|"     In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients     in this study are diagnosed with advanced melanoma with evidence of brain metastases and are     eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Patients will     undergo a dynamic PET scan of the brain to determine [18F]dabrafenib distribution and     kinetics in brain metastases. In addition, a static total body PET scan will be performed to     visualize whole body distribution and tracer uptake.   "
44690|NCT02700750|"     The investigators will enroll and scan normal eyes of healthy individuals using the     Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest     quality and 40 the best possible one. Each of the participants will be scanned numerous times     using this noninvasive imaging tool, while trying to get as many scans as possible of     different quality. The differences in the parameters between the scans will then be recoded.      Collected data will include age, sex, subjects' refractive status, visual acuity, full slit     lamp exam and the participants' OCT characteristics and measurements.   "
44691|NCT02700737|"     To answer the research question: Would image-based modelling result in different clinical     decisions as compared to clinical practice guidelines?, we will conduct a randomized     controlled experiment in which we will compare the hypothetical decisions made by     interventional cardiologists who are presented with imaging parameters currently recommended     by clinical practice guidelines vs. hypothetical decisions made by interventional     cardiologists receiving an expanded list of parameters, including simulation modelling.   "
44692|NCT02700724|"     This trial is a randomized, multi-center, non-inferiority study comparing observation versus     immediate surgery for low grade, noninvasive bladder cancer.   "
44693|NCT02700711|"     This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine     (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and     urine drug screens.   "
44694|NCT02700698|"     The main goal of this project is to determine whether mitochondrial function in circulating     cells is related to that measured in the muscle fibers of the same subjects.   "
44699|NCT02700633|"     Pacemaker requirement in the immediate post procedure phase following TAVI is approximately     20% depending on device type and patient characteristics. There is a signal from recent     studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60     days. This study aims to address whether there is a mortality advantage to having a pacemaker     in the short term   "
44700|NCT02700620|"     Background: Previous studies on Internet-based treatment with eating disorders have shown     promising results.      Objective: The first aim of this study was to investigate the effects of a tailored therapist     guided internet-based treatment for individuals with eating disorders. The second aim was to     examine the role of knowledge acquisition.      Method: 138 participants were recruited. Screening consisted of online questionnaires     followed by a telephone interview. A total of 92 participants were included after a     semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or     to a control condition (n=46). Treatment consisted of individually prescribed cognitive     behaviour therapy text modules in conjunction with online therapist guidance. The control     group consisted of a waitlist who later received treatment.   "
44701|NCT02700607|"     After obtaining approval from the Institutional Review Board of our institution, written     informed consent is obtained from patients undergoing interventional cerebral aneurysm     coiling procedure are enrolled in this prospective study and randomly allocated into one of     two groups: Group-C (n=10) and Group-HES (n=10).      All recruited patients will be given patient identification number (PIN) for the present     study of 01-20 according to their order of interview and recruitment. Investigators will     prepare 10 yellow and 10 green cards, which will be inserted in 20 thick-paper envelopes.     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 20     (Envelop number). After printing the envelope number outside envelope, all sealed envelopes     with cards will be conveyed to and kept in pharmacy department.      According to the color of the card, attending anesthesiologists will give crystalloid for     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.      Patient data and statistical analyses:      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be     determined from the patients' medical record after patient's discharge.      All statistical analyses will be performed after the 20th patient's discharge and data     acquisition   "
44702|NCT02700594|"     Patients with painful knee conditions often present with hip muscle weakness. This weakness     can lead to, and perpetuate, knee problems. Diminished strength causes movement impairments     that can lead to pathology, functional limitations and disablement. In some cases, this hip     muscle weakness is not caused by simple disuse and muscle shrinkage (atrophy). Hip weakness     may be caused by an inhibitory mechanism that limits the force output of a muscle. The     inhibition is reflexive and is in response to pain or joint dysfunction. Joint     mobilization/manipulation can quickly reduce pain and improve joint function, possibly     decreasing inhibition and increasing strength. Joint mobilization/manipulation may facilitate     strength recovery. By restoring strength sooner, the patient may avoid the deleterious     effects of prolonged muscle weakness and achieve quicker or better outcomes.   "
44703|NCT02700581|"     The purpose of this study is to determine the difference in the impact of moderate positive     end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac     surgery: conventional versus protective ventilation strategy The possible changes in forward     and backward flows (Doppler profiles) of hepatic venous flow at different degrees of PEEP in     conventional and protective ventilation strategies are analyzed by using intraoperative     transesophageal echocardiography (TEE) in patients undergoing cardiac surgery .   "
44704|NCT02700568|"     Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in     metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had     progressed on sunitinib or pazopanib in the first-line setting.   "
44705|NCT02700555|"     A prospective, single center, cohort study for surveillance of metabolic parameters in     patients who will receive chemotherapy after surgical resection of colorectal cancer   "
44706|NCT02700542|"     The New York City Department of Health and Mental Hygiene and Montefiore Medical Center, with     the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on a     study to evaluate the feasibility, health outcomes and return-on-investment of a single,     integrated pest management (IPM) intervention for Bronx, Harlem, and Northern Manhattan     children aged 5 to 12 with persistent asthma who are living in homes with pests. By     demonstrating cost effectiveness, this study could provide the basis for health insurance     coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients     living with pests.      Asthma is the most common childhood disease in New York City, and both prevalence and     hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and     community-level factor associated with asthma disparities is varying exposure to triggers in     the home, most notably cockroaches and mice. Asthma health care costs are significant, and     prevention efforts to reduce triggers could result in improved outcomes and significant cost     savings. Unlike traditional pest control, which relies on pesticides, IPM eliminates pests     and prevents re-infestation by addressing housing conditions conducive to pests and with     safe, targeted use of pesticides. This project targets low-income children with the potential     to significantly improve their health and well-being. A total of 400 families - 400+ children     which includes screened and recruited siblings - will be recruited on to the study.      The study is designed to evaluate an inexpensive and scalable environmental intervention for     asthma that can be replicated in other New York City neighborhoods and incorporated into any     urban healthcare setting in New York State and nationwide.   "
44707|NCT02700529|"     Leukotriene B4 (LTB4) inhibits lymphangiogenesis in the mouse tail model of lymphedema and is     elevated in tissue in patients with lymphedema. Ubenimex is an inhibitor of leukotriene A4     hydrolase (LTA4H), the biosynthetic enzyme for LTB4. This proof-of-concept study is designed     as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times     daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients     with leg lymphedema. The primary objectives for the study are:        -  To evaluate the efficacy of ubenimex in patients with leg lymphedema        -  To evaluate the safety and tolerability of ubenimex in patients with leg lymphedema   "
44708|NCT02700516|"     Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of     patients who receive a renal transplant. The exact prevalence of either recurrent or de novo     GN is unknown since a considerable number of patients never undergo allograft biopsy, leaving     GN underdiagnosed. The aim of this study is to evaluate the effects of recurrent GN on the     prevalence, risk factors, clinicopathological features, and outcome of renal transplant     recipients.   "
44709|NCT02700503|"     This study uses patient engagement to develop a diabetes prevention program focused on     adolescents and families.   "
44710|NCT02700490|"     This study is a cluster randomised controlled trial, which aims to examine the short-term     strategy of addressing treatment gap through increasing primary mental health service     capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a     specialist model of mental health care and an enhanced usual care (task-sharing) framework,     in terms of reducing mental health symptoms, reducing disability, and improving quality of     life, as well as the health services costs (and potentially societal costs) associated with     these outcomes in 400 patients.   "
44711|NCT02700477|"     Trigonella Foenum-Graecum, commonly known as Fenugreek, is a plant that has been extensively     used as a source of anti-diabetic compounds Fenugreek is traditionally used in India,     especially in the Ayurvedic and Unani systems.      Preliminary animal and human trials suggest possible hypoglycemic and anti-hyper lipidemic     properties of Fenugreek seed powder, when taken orally. Fenugreek seeds contain 50% fiber     (30% soluble fiber and 20% insoluble fiber) that can slow the rate of post-prandial glucose     absorption. This may be a secondary mechanism for the hypoglycemic effect.   "
44712|NCT02700464|"     Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder     EpiCheck test compared to the gold standard cystoscopy and pathology in patients under     monitoring for recurrence of bladder cancer.   "
44713|NCT02700451|"     Patients undergoing spine surgery often have considerable pain post-operatively and     frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control     their pain postoperatively. The widespread use of opioids, however, is associated with a     number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation,     dizziness and itching amongst others. Some investigators have suggested that     anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and     acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as     a result, lower opioid-related side effects.      The purpose of this study is to test this hypothesis and determine if postoperative     anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid     required to control pain following surgery. A secondary goal of this study is to examine if     the change in pain medication will lead to decreased overall pain levels, decreased     opioid-related side effects and improved function [quicker ambulation with physical therapy     (PT), earlier return to work, etc.].   "
44714|NCT02700438|"     A prospective randomized study was performed. Compliance with the treatment and healing rate     of chronic anal fissure in patients receiving glyceryl trinitrate ointment (GTO) and subjects     undergoing percutaneous posterior tibial nerve stimulation (PPTNS) were evaluated .   "
44715|NCT02700425|"     The goal of this study is to compare the effectiveness of pacing from a physiologic His     bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in     subjects with heart failure undergoing cardiac resynchronization therapy (CRT). While     placement of left ventricular leads via the coronary sinus has anatomic limitations, we     hypothesis that the achievement of QRS narrowing with His bundle capture will be superior for     improving systolic function by echocardiographic indices (ejection fraction and strain) and     quality of life and decreased rehospitalization and mortality.   "
44716|NCT02700412|"     The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various     doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating     debilitating, drug-resistant epilepsy.   "
44717|NCT02700399|"     The purpose of this study is to determine if the pulse pressure changes are different whether     patients are training in a traditional tilt table as compared to a robotic assisted tilt     table, which induces leg movement.   "
44718|NCT02700386|"     The proposed study is being done to learn more about a particular dose of radiation treatment     for breast cancer that is completed in a shorter amount of time than what has traditionally     been used to treat breast cancer. Subjects are being asked to be in this research study     because they have already had surgery for breast cancer and some cancer cells were found in     their lymph nodes that drain the breast tissue.   "
44719|NCT02700373|"     This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess     the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo.   "
44720|NCT02700360|"     A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the     Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral     Administration in Healthy Volunteers   "
44721|NCT02700347|"     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium     tuberculosis of pyrazinamide in combination with allopurinol. Pharmacokinetics (PK) and whole     blood bactericidal activity (WBA) will be measured in healthy volunteers following     administration of pyrazinamide alone and in combination with allopurinol.   "
44722|NCT02700334|"     Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired     fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of     progression type 2 diabetes mellitus (T2DM).      Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2)     co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion     through urine, so that the blood glucose is improved in patients with T2DM. Although this     mechanism is independent of insulin, there are evidence of improved secretion and insulin     sensitivity, so it is interesting to assess these effects in patients with prediabetes, as     potential therapy for treating such disorders and prevent progression to T2DM.      The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and     insulin sensitivity in patients with prediabetes.      The investigators hypothesis is that the administration of dapagliflozin improve insulin     secretion and insulin sensitivity in patients with prediabetes.   "
44724|NCT02700308|"     Conventional vertebroplasty is an effective option in the treatment of bone lesions     (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at     reinforcing a compressed vertebrae or at risk of fracture.      The main adverse event related to vertebroplasty use is the cement leakages that might be     responsible for significant clinical impairments.      Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on     balloon through the needle into the targeted vertebrae and then inflation of the balloon     prior to cement injection into the space.      In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.      To date, no data from randomized study are available in the population of cancer patients.   "
44725|NCT02700295|"     Orthokeratology has the benefit for slowing down myopia progression and enabling unaided     vision during the day. To investigate proposed possible changes of conventional and     multifocal orthokeratology in the cornea and choroid this study will image both structures     with high resolution optical coherence tomographs over a six month period. Findings will help     to plan larger trials over a longer period of time in adults and teenagers.   "
44726|NCT02700282|"     Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a     progressive decline in lung function.      School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack     carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle     strength is also impaired.      No studies assessed aerobic capacities during children's gait while carrying a backpack.      The investigators hypothesized that backpack carrying will induce an acute decline in lung     function in children with cystic fibrosis compared to healthy children. Investigators also     hypothesized that aerobic capacities will be impaired.   "
44727|NCT02700269|"     Investigators will evaluate approaches using magnetic bead capture, isolation, and surface     tension valve transfer of biomarkers to process capillary blood in order to improve the     sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria     infection. Results will be compared to those obtained using unenhanced capillary blood     specimens directly applied to approved malaria RDTs. Participants seeking care for possible     malaria in Zambia will be recruited to enroll in the study.   "
44728|NCT02700256|"     The purpose of this pilot study is to find out if patients are willing to self-report     symptoms in the first 5 days following discharge, or when they leave the hospital after     ambulatory surgery (ambulatory surgery is when the patient has surgery and then goes home     within 24 hours).   "
44729|NCT02700243|"     In this research study the investigators want to learn more about whether using a fitness     tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in     turn whether it increases exercise tolerance over the period of one year.   "
44787|NCT02699489|"     A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and     open donor nephrectomy within a specified enhanced recovery protocol   "
44730|NCT02700230|"     This phase I trial studies the side effects and the best dose of a vaccine therapy in     treating patients with malignant peripheral nerve sheath tumor that cannot be removed by     surgery (unresectable) or has come back after a period of improvement (recurrent). Vaccines     made from a gene-modified virus may kill tumor cells expressing a gene called neurofibromin 1     (NF1) without affecting surrounding normal cells and may also help the body build an     effective immune response to kill tumor cells.   "
44731|NCT02700217|"     About 1100 living donor nephrectomies are performed in the UK every year contributing to     almost 35% of all the kidney transplants. Laparoscopic surgical techniques are general     employed for donor nephrectomy as they are associated with a shorter hospital stay and faster     return to normal physical functioning. Local anaesthetic infiltration technique with or     without spinal anaesthesia in combination with a general anaesthetic is increasingly being     used as part of enhanced recovery programme across general surgery. The impact of combined     spinal and general anaesthesia along with local infiltration and rectus sheath blocks on     acute pain has not been studied in patients undergoing hand assisted laparoscopic live donor     nephrectomy.      The investigators plan to investigate whether adding a spinal anaesthetic to a conventional     general anaesthetic technique actually influences clinical outcomes of length of hospital     stay and acute pain in patients undergoing hand assisted laparoscopic live donor nephrectomy.      The investigators plan to randomise 90 patients undergoing hand assisted laparoscopic live     donor nephrectomy over 24 month period at Central Manchester University hospitals and divide     them in two groups of 45 each. Group A will receive a general anaesthetic (GA) with spinal     anaesthesia (Spinal group) and Group B will receive a GA with a rectus sheath block (Rectus     sheath group) and local anaesthetic infiltration   "
44732|NCT02700204|"     This is an open-label, two-arm, histological evaluation study.      Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to     receive PicoWay fractional treatment:      Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri     auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece      All subjects will have biopsies from the treated area:        -  at baseline prior to treatment;        -  immediately after treatment (within 30 minutes) or 48 hours after treatment;        -  2 months after treatment. Methodology described in the protocol to evaluate efficacy and          safety of treatments will be carried out at each visit at the clinic.   "
44733|NCT02700191|"     Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be     given the µ-Cor system to be added to their standard care, and randomized 1:1 to an     interventional arm or a control arm.   "
44734|NCT02700178|"     This study will evaluate movement of the arm and forces put through the hand during     activities performed in a manual wheelchair. The goal of this study is to identify what     motions and forces are most likely to lead to the development of pain or pathology and     determine the feasibility of strategies to modify movements and decrease risk.   "
44735|NCT02700165|"     The purpose of this study is to further evaluate the safety and efficacy of non-invasive     reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.   "
44736|NCT02700152|"     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the     UltraShape treatment for non-invasive abdominal fat reduction.      Study subjects will undergo UltraShape treatments on the abdominal area   "
44737|NCT02700139|"     The aim of this clinical trial is to compare the rate of myopic progression in children     wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design is     an aspheric lens which is supposed to slow myopic progression in children by unique     asphericity (proprietary information). Myopic progression is quantified by changes in axial     length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6 months     crossover) with double-masking. Peripheral refraction and ocular aberration will be     evaluated.   "
44738|NCT02700126|"     In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently     used due to brain relaxation and less effect on electrophysiologic monitoring. Response to     propofol can vary between individuals and be associated with clinical factors including age     and weight, and genetic polymorphism. Because the importance of rapid recovery in     neurosurgery with long operation time is emphasized recently, the choice and dose adjustment     of anesthetics should be determined according to clinical and genetic factors. Recently,     researches about genetic variations have been performed with single nucleotide polymorphism     (SNP). The aim of this study is to determine SNPs associated with propofol recovery and     response in Korean adult population undergoing propofol based TIVA for clipping of unruptured     cerebral aneurysm.   "
44739|NCT02700113|"     The purpose of this study is to provide a detailed description of language and cognitive     profiles found among children and adolescents diagnosed with autism spectrum disorders (ASD).     Participants with ASD ages 4-17;12 years who have limited verbal skills will be given     comprehensive behavioral assessments to collect data that will advance our understanding of     language-related processes in individuals with ASD, the knowledge of which will help in     designing future interventions for this population.   "
44740|NCT02700100|"     The study is a prospective, non-randomised, open label clinical study to assess the safety of     the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects > 2 years and < 22 years     of age, undergoing Right Ventricular Outflow Tract (RVOT) reconstruction. It is a first in     man feasibility study which will include 10-12 patients in up to 6 sites in Europe.      The primary objective of the study is to assess the survival rate of subjects at 6 months     following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001).      Secondary objectives:        1. The survival rate of subjects at 12 months following implantation of the Bioabsorbable          Pulmonary Valved Conduit (PV-001)        2. The percentage of conduit failure at 6 months and 12 months, where conduit failure          includes the need for reintervention or reoperation.        3. The pressure gradient across the pulmonary valve will have an acceptable level at 12          months follow up.        4. The pulmonary regurgitation measured will not exceed a moderate grading at 12 months          follow up.        5. To evaluate the usability of the Bioabsorbable Pulmonary Valved Conduit (PV-001) during          the surgical procedure, using exploratory parameters      Long term safety will be assessed up to 60 months post implantation.   "
44741|NCT02700087|"     All neonates, ages 0 to 4 months, presenting to LPCH pediatric ENT clinic for airway     difficulties or stridor will be screened for inclusion. As is consistent with an acceptable     standard of medical care, these children will undergo a flexible nasal endoscopic exam to     make the diagnosis of laryngomalacia, as well as be weighed and a breastfeeding history     taken. If laryngomalacia is present, the study staff with then administer the Infant     Gastroesophageal Reflux Questionnaire (IGERQ) and an airway symptoms questionnaire (ASQ).      Those babies with an IGERQ score of less than sixteen (no more than mild reflux) and an ASQ     score greater than six will be eligible for randomization. The patient will then be randomly     placed in the control group (placebo) or the intervention group (ranitidine 2mg/kg every 12     hours or famotidine 0.5 mg/kg daily). Patients will stay on medication for a minimum of 6     months, or until symptoms resolve. Patients will be seen in follow up at 1, 2, 3, 4, 5, 6, 8     and 10 months. At which time I-GERQ, ASQ and weights will be taken. The primary outcome     measure will be the time for the ASQ score to drop to normal on ranitidine or famotidine     versus placebo.      A secondary outcome will be weight gain in percentile. If the patient's I-GERQ score goes     above 16 at any time in the study, the patient will be crossed over to the treatment arm and     started on medical treatment.   "
44742|NCT02700074|"     The main goal of our study is to find out why some people with Autism Spectrum Disorder (ASD)     do not develop verbal abilities or remain minimally-verbal throughout adolescence and     adulthood. Current research focuses on investigating brain differences related to processing     sounds and initiating speech in adolescents and young adults with ASD varying in language     skills, compared to adolescents who do not have ASD, in order to clarify whether atypical     processes of auditory perception, perceptual organization and/or neural oscillation patterns     may explain why some individuals with ASD fail to acquire functional speech.   "
44743|NCT02700061|"     The purpose of this study is to evaluate and compare the effects of upper limb training with     Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor     function, neurological evaluations and quality of life are assessed for the comparison of the     therapies.   "
44744|NCT02700048|"     This is a single center, single-blind randomized cross over design trial that will compare     the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental     hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators     intend to enroll 18 individuals to obtain the complete data sets from 15 participants.     Expected duration of subject participation is 10-12 weeks. This study will consist of two     2-day intervention visits separated by approximately 8 weeks.   "
44745|NCT02700035|"     This study will complete a multisite randomized controlled trial (RCT) of a family-centered     alcohol and drug prevention program for Anishinabe (Ojibwe) pre-adolescents in 3rd or 4th     grade (Fall 2017) or who are age 8-10 years on June 1, 2017. The 14 week program includes     cultural lessons to strengthen family interactions, decrease substance use, teach parenting     skills, increase social skills, improve refusal skills, and teach coping mechanisms for     adolescents and parents. Session are expected to last around 3-hours, including a meal, youth     and parent breakout sessions, and group based discussions. Parents and adolescents will     participate in a pre-test before the program begins and a series of post-tests after the     program ends.   "
44825|NCT02698982|"     The aim of this study is to demonstrate that in elderly and frail patients, a narrower     control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP     monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of     postoperative cognitive impairment and the hospital length of stay.   "
44746|NCT02700022|"     This phase I/Ib study is designed to establish the safety and maximum tolerated dose (MTD,     which will also be the recommended phase II dose (RP2D)) of the aurora kinase A inhibitor     alisertib when combined with dose-adjusted (DA)-R-EPOCH (rituximab, etoposide, doxorubicin,     vincristine, cyclophosphamide and prednisone) in patients with CD20-positive diffuse large     B-cell lymphoma (DLBCL), transformed follicular lymphoma or Burkitt lymphoma positive for Myc     gene rearrangement (Myc+). Filgrastim or peg-filgrastim is also included with each cycle of     R-EPOCH. Once we identify the MTD, an expansion cohort limited to the Myc+ DLBCL population     will be opened to further characterize clinical activity and safety.      Secondary objectives include estimates of complete response rate (CR) and progression free     survival (PFS). We will also explore for associations between baseline kinome signatures     and/or RNA sequencing and CR, and identify differential kinome and transcriptome prior to and     during treatment.   "
44747|NCT02700009|"     Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective     in previous studies in psychiatric settings, will be disseminated into primary care - a     health care setting where there are significant problems in receiving adequate treatment for     depression. Computer-assisted cognitive-behavior therapy will feature a low-cost method of     delivering therapy designed to be replicated and sustained in other primary care settings.     Feasibility and effectiveness will be tested by randomly assigning 320 primary care patients     with depression to receive either computer-assisted cognitive-behavior therapy or treatment     as usual.   "
44748|NCT02699996|"     This partially randomized pilot trial studies peer mentoring to see how well it works in     promoting follow-up care self-management in younger childhood cancer survivors. Childhood     cancer survivors require lifelong follow-up care to identify, monitor, and treat medical and     psychosocial late effects stemming from their cancer, its treatment, and lifestyle factors. A     peer mentoring program may improve disease knowledge, health motivation, problem-solving     skills, stress management, and communication with caregivers and providers in adolescent and     young adult cancer survivors.   "
44749|NCT02699983|"     This randomized pilot clinical trial studies how well a virtual weight loss program     (SparkPeople) works in helping female African American breast cancer survivors maintain a     healthy weight. Many patients with breast cancer are overweight or gain weight after     diagnosis. SparkPeople is a free web-based weight loss program that features educational and     motivational articles and videos, self-monitoring tools, incentives, social support     communities (including discussion forums, teams, challenges, and expert blogs), and options     for content to be delivered to members' email. It is a comprehensive program that includes     advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet     and exercise), and emphasizes safe weight loss and receiving medical attention regularly when     needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a     healthy weight, which may reduce the risk of cancer returning and patient fatigue, and     improve patient quality of life.   "
44750|NCT02699970|"     The objective of this study is to evaluate precision of the Philips Dx system.   "
44751|NCT02699957|"     The Left Atrial Appendage Occlusion Registry (LAAO Registry™) is designed to assess the     prevalence, demographics, management, and outcomes of patients undergoing percutaneous and     epicardial based left atrial appendage occlusion procedures to reduce the risk of stroke.     Patient-level data will be submitted by participating hospitals on a quarterly basis to the     American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). The     primary aims of the LAAO Registry are to optimize the outcomes and management of patients     through the implementation of evidence-based guideline recommendations in clinical practice,     facilitate efforts to improve the quality and safety for patients undergoing percutaneous and     epicardial based left atrial appendage procedures, investigate novel quality improvement     methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR     data. The secondary purpose of the LAAO Registry is to serve as a rich source of clinical     data to support assessments of short- and long-term safety, comparative and cost     effectiveness research, and as a scalable data infrastructure for post market studies.   "
44752|NCT02699944|"     Despite advancements in implant technology and various techniques of optimization, there is     still around 30% non-responder rate to cardiac resynchronization therapy (CRT). This study     will assess the potential benefit of a body surface mapping technology to optimize CRT     devices in the chronic sub-optimal responder setting.   "
44753|NCT02699931|"     This study evaluates if electric toothbrushes with a 3D action (rotation / oscillation and     pulsation) are more effective than manual toothbrushes in removing plaque and reducing     gingival inflammation in patients under orthodontic treatment with fixed appliances.   "
44754|NCT02699918|"     Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending     check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult     patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a     nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal     nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea     syndrome. Patients with sleep apnea will be treated.      Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and     cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.   "
44755|NCT02699905|"     This study seeks to elucidate the quantitative expression of G - protein receptor 43/free     fatty acid (GPR43/FFA2) receptors in patients with the diagnosis of sepsis and specifically,     its expression as it relates to the severity of sepsis. The investigators hypothesize that     patients with more severe sepsis, as defined by a higher SOFA (Sequential Organ Failure     Assessment Score), will have decreased expression of the GPR43/FFA2 as compared to patients     with lower SOFA scores, consistent with a less exuberant immune response to infection.      Patients admitted to Penn State Hershey Medical Center with a diagnosis of sepsis of any     cause will undergo blood testing of leukocytes to determine the expressed quantity of GP43     during standardized time points of their illness and recovery. No interventions will be made     in the standard clinical management of the patient. Additionally, healthy volunteers will be     recruited to exam baseline GPR43 receptor expression between sepsis and control groups.   "
44826|NCT02698969|"     Diaphragm ultrasonography as a diagnostic tool in order to demonstrate the superiority of     Sugammadex vs. AChEI in facilitating post-operative neuromuscular recovery.   "
44756|NCT02699892|"     This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective     study will examine the efficacy and safety of rituximab in participants who had previously     received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab     will be determined 24 weeks after receiving the first infusion, 24 weeks after the second     infusion repeated courses of treatment (if the participants receive another course of     rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the     participants receive third course of rituximab). Protocol does not specify the criteria for     initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab     will be administered at the discretion of treating physician according to approved label.   "
44757|NCT02699879|"     This single arm, post-authorisation study is designed to evaluate the long-term safety of     pirfenidone in participants with IPF. The enrolment of participants will be completed within     approximately 24 months. Participants will receive pirfenidone according to the physician     discretion and will be followed for 2 years. Treating physicians will collect pre-specified     data at the baseline and every 3 months thereafter, for the duration of the participants'     participation in study.   "
44758|NCT02699866|"     The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow     treatment of patients with single tooth gaps of small dimensions in the lateral and central     incisor positions in the mandible and in the lateral incisor positions in the maxilla. These     positions are reduced-load-bearing compared to more posterior positions.      During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the     clinical practice setting will be investigated.   "
44759|NCT02699853|"     This randomized phase II trial studies how well robotic radical cystectomy (RRC) or open     radical cystectomy (ORC) works in treating patients with bladder cancer. Cystectomy is a     surgical procedure to remove all or part of the bladder (the organ that holds urine) or to     remove a cyst (a sac or capsule in the body). In RRC, the the surgeon makes small cuts in the     abdomen and uses a thin, lighted instrument with a camera attached called a scope. With the     help of a robot, the surgeon removes the bladder and other nearby structures. In ORC, the     surgeon makes a cut into the lower abdomen to expose the urinary tract in order to remove the     bladder and nearby structures. It is not yet known whether RRC or ORC has fewer     complications, better quality of life, and faster recovery time in treating patients with     bladder cancer.   "
44760|NCT02699840|"     The aim of this study is to generate local data on the safety of Menactra® in individuals 2     to 55 years of age in the Russian Federation.      Primary Objective:        -  To describe the safety profile after 1 dose of Menactra® administered in individuals          2-55 years of age under standard health care practices.   "
44761|NCT02699827|"     This study aims at evaluating the effect of adding magnesium sulphate epidurally as an     adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in     patients with preeclampsia undergoing elective caesarian section (CS).   "
44788|NCT02699476|"     The purpose of this study is to compare different combinations of cognitive training in     retired professional football players and military veterans with a history of repeated     concussions and persistent symptoms of impaired memory, concentration, attention, focus, or     thinking.   "
44762|NCT02699814|"     The goal of this project is to develop and pilot test a community-based integrated care model     to improve the prevention, early detection and treatment of child mental health problems that     is replicable, effective, and sustainable. Project procedures include child mental health     screening, on-site brief mental health interventions, referral to specialty mental health,     use of co-located child psychiatrist, detection of need for primary care in specialty mental     health program. Subjects will be enrolled for 1 year, with interviews at baseline and 3, 6     and 12 months.      Dr. Bonnie Zima at UCLA has been contracted by the project funder to design and implement the     evaluation of the project, which includes developing data collection procedures, training     staff on implementation of data collection workflow, coordinating with sites to ensure     evaluation design and IRB protocols are followed, and coordinating with both study sites to     verify data reliability.      Some potential anticipated risks include being uncomfortable answering questions associated     with the measures used in the study, and although unlikely, someone may access participant     information that is confidential. Some benefits include helping to find ways to improve how     to deliver mental health care for children served in publicly-funded primary care and mental     health clinics.   "
44763|NCT02699801|"     Increasing numbers of elderly patients are undergoing cardiac surgery. Elderly patients may     have prolonged recovery following cardiac surgery when compared to other groups of patients,     and are at higher risk of postoperative delirium, postoperative neurocognitive decline and     reduced quality of life following hospital discharge.      The goals of sedation and analgesia for patients following cardiac surgery are multifold and     include postoperative pain relief, the facilitation of ventilation, resolution of hypothermia     and normalization of electrolyte balances. The choice of sedative agent however can impact     postoperative outcomes. Dexmedetomidine has been associated with improved quality of recovery     in patients undergoing major spine surgery and with a reduced incidence of delirium, both of     which can impact a patient's quality of life following surgery. The investigators     hypothesized that the use of dexmedetomidine as a sedative agent immediately following     cardiac surgery in elderly patients would result in improved quality of recovery and a     reduced incidence of delirium in the postoperative period, when compared to propofol. The     investigators were also interested as to whether there was an associated improvement in     neurocognitive outcomes in this population.      Questions:        -  Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients following          cardiac surgery result in improved Quality of Recovery scores when compared with          propofol?        -  Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients following          CABG+/- AVR result in a reduced incidence of postoperative delirium as compared to          propofol?        -  Do these patients subsequently have a reduction in cognitive decline?   "
44764|NCT02699788|"     The goal of this study is to assess a new non-invasive computerized, multiphase, resting     electrocardiogram analysis device in early identification of patients at risk for acute     coronary syndrome. The overall objective is to assess the association between the results     from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency     department with suspected coronary disease.   "
44765|NCT02699775|"     Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity     and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies     demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved     kinematic gait parameters(GP) but surprisingly none of them assessed the effects of     repetitive multifocal BTI on patient's gait pattern and their duration.      The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic     stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after     3 consecutives BTI sessions.   "
44766|NCT02699762|"     To show that the addition of a self-rehabilitation program to standard treatment, involving     repeated BTI and usual physiotherapy, improves impairment and activity limitation of the     paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a     randomised controlled study of patients with spastic hemiparesis following stroke.   "
44767|NCT02699749|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and     maximum tolerated dose (MTD) of TAK-931 in participants with advanced nonhematologic tumors.   "
44768|NCT02699736|"     The EuroSIDA study is a prospective observational cohort study of 20,000+ patients followed     in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest     pan-European cohort study and few studies of a comparable design are available on a global     scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into     the study through 10 cohorts since 1994.      The main objective of the study remains the same as in1994: to prospectively study, clinical,     therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across     Europe in order to determine their long-term virological, immunological and clinical     outcomes.      Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as     the dramatic changes in morbidity and mortality when combination anti-retroviral therapy     (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected     patients, it is important for EuroSIDA to remain in the forefront of investigating the     treatment benefits and adverse effects.      All study documents, study status, newsletters, scientific publications and presentations are     available online and are updated continuously at project website.      In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective     collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort     of consecutive HIV infected patients from across Europe in order to (1) assess the factors     associated with the clinical, immunological and virological course of HIV infection and     HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a     surveillance system to describe temporal changes and regional differences in the clinical     course of HIV and HIV-related co-infections and co-morbidities in Europe.   "
44769|NCT02699723|"     This pilot clinical trial studies how well arsenic trioxide and itraconazole work in treating     patients with basal cell cancer that has spread to other places in the body and usually     cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as arsenic     trioxide, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Itraconazole may     help treat fungal infections in patients with basal cell cancer. Giving arsenic trioxide with     itraconazole may work better in treating basal cell cancer.   "
44789|NCT02699463|"     The investigators wish to prospectively determine the response to CPAP in patients presenting     with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not     reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA     when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to     add to this pool of knowledge and also increase the inclusion criteria to include the AASM     2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the     investigators will add novel information to the field by assessing the benefits of treatment     in both sub-groups of mild OSA.   "
44770|NCT02699710|"     This study is a Phase I, single center, randomized (Parts 1 and 2 only), open-label, 3 part     study. Parts 1 and 2 are 2-way crossover, with 1-fixed sequence, 3-period designs to     investigate the effect of formulation, food and rabeprazole on the PK of GDC-0853 in healthy     male and female (of non-childbearing potential) participants. Part 3 is a fixed-sequence     study with 3 treatments to characterize the steady-state PK of the GDC-0853 tablet; the     effect of simultaneous administration of a single dose of methotrexate on the steady-state     kinetics of GDC-0853; and the effect of dosing GDC-0853 to steady-state on the single dose PK     of methotrexate in healthy male participants.   "
44771|NCT02699697|"     This randomized phase II trial studies how well palliative radiation therapy works in     reducing pain in patients with cancer that has spread from the original (primary) tumor to     the bone (bone metastasis). Palliative radiation therapy using external beam radiation     therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by     cancer.   "
44772|NCT02699684|"     The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses     compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.   "
44773|NCT02699671|"     The purpose of this study is to evaluate the relative effectiveness and safety of     Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug     eluting stents) DES.   "
44774|NCT02699658|"     Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a     broad spectrum of activity. In common with other fluoroquinolones, the main     pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy     is the area under the plasma time-concentration curve/the minimum inhibitory concentration     ratios.      The aims of the study were to:        1. reveal the population pharmacokinetics, and        2. assess the efficacy of various dosage regimens in achieving the probability of target          attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral          levofloxacin was prescribed as the switching therapy after intravenous levofloxacin          treatment.      The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of     levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to     determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens     were predicted to achieve CFR greater than or equal to 90%.   "
44775|NCT02699645|"     An investigator initiated and conducted, multicentre, international, double-blinded,     placebo-controlled, parallel-group, randomised controlled trial to determine the effects of a     fixed low-dose combination blood pressure lowering pill (Triple Pill) on top of standard of     care on blood pressure control and on time to first occurrence of recurrent stroke in     patients with a history of acute intracerebral haemorrhage (TRIDENT).   "
44776|NCT02699632|"     The main goal for this study is to assess concerns and barriers to research participation by     pregnant women through an anonymous online survey     (www.pbrc.edu/ParticipateWhilePregnantSurvey).   "
44777|NCT02699619|"     Femoral neck fractures represent about half of the hip fractures and are further divided into     displaced and undisplaced fractures. Displaced femoral neck fractures are almost always     treated surgically with arthroplasty. However there is an ongoing debate on which implant is     superior for undisplaced fractures.      A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the     original implant consisted of 2 isolated hook pins, the modified design consists of 3     titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of     implant design and improves fixation and load transfer amongst the pins. The superiority of     the modified design is so far only proven preclinically.      The role of the Pinloc in clinical use remains unclear. Investigators are planning a     randomized controlled trial on undisplaced femoral neck fractures to establish a method for     implanting the tantalum markers, to observe the fracture healing process and to further     investigate the role of the Pinloc.   "
44778|NCT02699606|"     The primary purpose of this study is to evaluate objective response rate (ORR) as per     Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a     molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC),     urothelial cancer, esophageal cancer and cholangiocarcinoma.   "
44779|NCT02699593|"     This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test     and control lenses in random succession. The objective is to evaluate materials from     different suppliers.   "
44780|NCT02699580|"     This study is to investigate protective effect of biodegradable collagen implant in scleral     showing after lateral rectus recession in patients with exotropia.   "
44781|NCT02699567|"     The purpose of this study is to determine the effect of common human variants in in taste     related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste perception.   "
44782|NCT02699554|"     Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other     neurological disorders. In this research, the investigators are developing new tools to     quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of     the most common treatments, orthopaedic surgery. The results from this research will empower     clinicians to identify patient-specific factors that contribute to impaired movement and     improve treatment and quality of life.   "
44783|NCT02699541|"     In this study, researchers will test the effectiveness of a self-management education     programme, on self-management behaviours of patients with type two diabetes. Up to 230     consenting participants will be recruited from outpatient diabetes clinics in Jordan, 230     participants will be randomised to one of two groups. Group 1 ( 115 patients) have received     the intervention, which consisted of an introductory session of tailored, face-to-face     education and advice, followed by educational materials to take away, and regular telephone     support at a regularity specified by the patient, over a three-month period. This     intervention is based on behavioural change theory called the     Information-Motivational-Behavioural skills model. Group 2 (115 patients) have received usual     clinical care with no additional intervention. Researchers have assessed the effectiveness of     the intervention by measuring self-care strategies (dietary habits, physical activity and     managing diabetes medications), diabetes control (HbA1c), quality of life and Diabetes     Self-Management Knowledge, Motivation and Self-Efficacy at 3 time points: before the     intervention, at 3 months and at 6 months.   "
44784|NCT02699528|"     To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in     children with attention deficit disorder   "
44790|NCT02699450|"     This is a multiple-center, multiple-dose, randomized, active comparator-controlled,     double-masked, three parallel group, 36-week study in participants with center-involving     diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes     meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA)     will be defined as the study eye. The study will consist of a treatment period (20 weeks) and     an observational period (up to 16 weeks). Treatment naive participants will be randomized in     a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated     with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in     a 1:1 ratio to Arms A and C.   "
44791|NCT02699437|"     The purpose of this study is to determine the prevalence of positive antiphospholipid     antibodies among women with preeclampsia and to determine the effect of antiphospholipid     antibodies on the severity of preeclampsia and the obstetric outcomes   "
44792|NCT02699424|"     This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy.     Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to     the prostate bed and thereafter be classified as either responders or non-responders     depending on PSA response at fifth week of radiotherapy.      A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment     week in order to identify cancer lesions in patients with poor PSA response. Patients with     PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst     patients with poor PSA response may be in need for additional therapy such as radiotherapy to     lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3     lymph node metastases or distant metastases will not receive any more radiotherapy, but     individualized systemic therapy will be started.   "
44793|NCT02699411|"     We will conduct a randomized clinical trial observing forty patients divided into two groups:     one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform     dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform     techniques proprioception (group a); and twenty patients not be treated with dry needling     after ACL surgery, using only proprioceptive exercises to the joint (group B).   "
44794|NCT02699398|"     The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is     superior than domiciliary occupational therapy for inducing functional gains, enhancing     corticospinal excitability, and cortical reorganization.   "
44795|NCT02699385|"     The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration     therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting     associated with acute gastroenteritis (AG) within the first 48 hours of treatment     administration in pediatric participants with AG and mild-to-moderate dehydration.   "
44796|NCT02699372|"     This randomized, single center, adaptive single ascending dose (Part 1) and multiple     ascending dose (Part 2) study is designed to assess the safety, tolerability,     pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus     placebo in healthy volunteers. The anticipated duration of this study is approximately 18     weeks.   "
44797|NCT02699359|"     The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic     signal analysis to calculate ICP on a continuous basis. Initial HS-1000 clinical data also     shows promise in assessing a variety of cerebral hemodynamic parameters such as cerebral     blood-flow, auto regulation monitoring, and cerebrovascular vessels compliance. In the     absence of a non-invasive monitor of intracranial pressure (ICP), the relationships, if any,     that may exist between concussion, timing of the concussion (e.g. acute, resolving, resolved)     and ICP is unknown. The new HS-1000 non-invasive device may provide insight into assessment     of possible ICP changes following concussion in children.   "
44798|NCT02699346|"     The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and     accurately monitor concussed patients with minimal discomfort, potentially providing a new     modality for concussion measurement. The device is based on advanced signal analysis     algorithms that analyze a very low frequency acoustic signal (within the audible range)     generated by the device. The acoustic signal is transmitted using a small transmitter, placed     in the participant's ear, and picked by an acoustic sensor placed in the other ear.   "
44799|NCT02699333|"     Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly.     Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology     is unknown. Understanding the etiology of microscopic colitis is an important step in     developing logical interventions to decrease the burden from microscopic colitis. This     research could provide critical insights into the etiology of this poorly studied condition.   "
44800|NCT02699320|"     There are no reports involved the intestinal microbiota from Chinese infants with short bowel     syndrome (SBS) under different clinical status. Alterations in the microbiota are closely     correlated with the bile acids and short chain fatty acids metabolism as well as the     intestinal immunity. A relatively comprehensive profile composed of microbial structure,     microbial metabolism products and immune biomarkers in SBS infants may facilitate a better     therapy strategy to complications occurred in SBS children.   "
44801|NCT02699307|"     Physical activity is the cornerstone of good diabetes management, and yet effective physical     activity intervention is not available. The investigators developed a lifestyle intervention     based on individual's home activity patterns. The goal of the study is to test the efficacy     of this intervention among older adults with diabetes. In addition to physical activity, the     investigators will also assess if the intervention will improve social participation.   "
44802|NCT02699294|"     This randomised-controlled trial investigates whether a single intervention of manual     pressure release combined with stretching exercise has an effect on muscle length, pain     perception threshold, and respiratory function in subjects with latent myofascial trigger     point in the pectoralis minor muscle or not. First quarter of the participants will receive a     single intervention of manual pressure release combined with contract-relax PNF stretching     exercise of pectoralis minor muscle, second quarter of the participants will receive a single     intervention of manual pressure release combined with Z stretching exercise of pectoralis     minor muscle while, only a single intervention of manual pressure release will be applied to     third quarter of the participants and final quarter of them will not receive any     intervention.   "
44803|NCT02699281|"     Investigators planned to adopt the N-of-1 trial approach to objectively test the     effectiveness of ultra-micronized PEA at an individual level in our older outpatients. 65     years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca' Granda     Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any origin     will be eligible. Each trial will be a placebo-controlled randomized crossover trial     including two um-PEA (600 mg twice a day) and placebo treatment pairs. Investigators will     secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average     effect of um-PEA compared with placebo using a frequentist and Bayesian approach.   "
44804|NCT02699268|"     This is a cross-sectional observational study, aiming to validate the accuracy of tidal     breathing measurements in infants made by VoluSense Pediatrics, a lung function method based     on electromagnetic inductance plethysmography, compared to an ultrasonic flowmeter. VoluSense     Pediatrics consists of a flexible vest placed around the torso of the baby, and changes in     tidal volume and flow is measured. The study will enable a better understanding of the     usefulness of this equipment. The equipment is made by VoluSense Norway AS, and is owned by     Haukeland University Hospital.   "
44805|NCT02699255|"     The investigators study aimed to observe the occurrence of new premature ventricular     complexes and other ventricular arrhythmias after pulmonary vein isolation.   "
44806|NCT02699242|"     The aim of the study is to study whether training by residents or anesthesia assistants, on a     recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance of     fiberoptic intubation in patients.   "
44807|NCT02699229|"     For this study the investigators are looking to do the following:        1. To characterize human lung lesions by nonlinear microscopy using ex vivo tissues.        2. To establish the first spectral/structural database for nonlinear optical microimaging          of normal and abnormal lung tissue.   "
44808|NCT02699216|"     This study evaluates the treatment of Dry Macular Degeneration and the resulting change in     vision with a very, very low current that is similar to what occurs in the body naturally. In     Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no     treatment). After the treatment period of one week, those not treated will be treated. In     Phase 2, all participants will be treated.   "
44827|NCT02698956|"     This is an international, mutli-center, prospective, consecutively enrolled, observational     registry. 2000 patients are planned to be enrolled over one year at up to 150 participating     sites.      300 patients out of the 2000 patients enrolled in the main registry are planned to be     consecutively enrolled in a select few sites for studying the valve performance.     Echocardiogram and angiogram will be taken routinely.   "
45227|NCT02693652|"     A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy     of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus     carriers   "
44809|NCT02699203|"     In addition to its role as the major regulator of glucose uptake into peripheral tissues, the     hormone insulin is also a primary regulator of fat storage and fat burning of the body.     Mechanistic animal studies have shown that high insulin may be the initial trigger for weight     gain and be the proximal cause of obesity. There is currently no quick or non-invasive way of     measuring insulin as research and clinical techniques require collection of a blood sample     followed by a complicated and costly biochemical assay. The investigators will test the     hypothesis that insulin levels can be accurately measured in saliva in humans following meals     that elicit high and low blood insulin responses. Findings will help determine if insulin can     be use as a valid fluid to track insulin changes in humans.   "
44810|NCT02699190|"     The purpose of this study is to establish the ability of Next-Generation Sequencing (NGS)     technologies to provide a diagnosis in a group of participants with suspected leukodystrophy     as determined by clinical symptoms, including MRI imaging, but without a specific genetic     diagnosis. Cost-effectiveness and clinical utility of whole genome sequencing will also be     investigated as part of the study.   "
44811|NCT02699177|"     1. Assessment of a high speed video camera with a green light source for the measurement of          ciliary beat frequency (CBF) in the nasal airways of patients.        2. Assessments of the effect of drugs and other therapies on CBF using the study system.        3. Comparison of results with standard methods such as ciliary brush biopsies   "
44812|NCT02699164|"     This study was conducted with the aim of determining whether or not Non surgical spinal     decompression therapy was effective in remission of herniation, decreasing pain and improving     functional status.   "
44813|NCT02699151|"     Superficial vein thrombosis (SVT) and venous thromboembolism (VTE) are related entities. Only     in the last years a series of observational studies mainly conducted in France could show     that ´isolated SVT´ (without concomitant deep vein thrombosis and/or pulmonary embolism) is     in fact not a benign and spontaneously healing disease but bears a potential for severe     thromboembolic complications once not treated adequately. INSIGHTS-SVT study aims at     collecting representative data on the current management and outcomes of SVT in Germany under     real-life conditions. It will document the implementation of the recently issued national SVT     guidelines issued by the Society for Angiology (DGA) and the Society for Phlebology (DGP).   "
44814|NCT02699138|"     Obstructive sleep apnea (OSA) has traditionally been attributed only to a collapsible upper     airway. However, it is increasingly recognized that multiple additional non-anatomical     mechanisms contribute to the disease. Higher rates of OSA in patients with post-traumatic     stress disorder (PTSD) than in those without PTSD have been reported however the mechanism     behind this increased prevalence has not been investigated. Our hypothesis is that patients     with PTSD have a predisposition to OSA due to a lower respiratory arousal threshold (wake up     too easily) than patients without PTSD. The goal of this project will be to study and compare     the ArTH in patients with PTSD and those without. In addition, we plan to see whether     medications can be used to increase the arousal threshold and treat OSA in patients with     PTSD.   "
44815|NCT02699125|"     Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.     They often develop high blood pressure. We are not sure what drug is best to treat the high     blood pressure. This study will give the patients guanfacine or hydrochlorothiazide (HCTZ)     for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24     hour monitoring.   "
44816|NCT02699112|"     To assess patients with hypercapnic respiratory failure using echocardiography,cardiac output     measurements and markers of neural respiratory drive (EMGpara) prior to, during and after     non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months. The     investigators hypothesize that the improvement in cardiac function and/or respiratory     mechanics over time are associated with ongoing improvements in oxygenation, quality of life     and exercise capacity.   "
44817|NCT02699099|"     The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the     SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and     yellow fever vaccines to children aged 6 months at the first vaccination.   "
44820|NCT02699060|"     This study is proposed to evaluate the role of motoric dysfunctions and burden of different     kinds of refluxate on immune cells and the subsequent course of the disease. This study also     aims to establish a bridge between instrumental findings (pH-impedance test) and clinical     assessments (FSSG questionnaire), aiming to facilitate the use of simple questionnaire     techniques in the clinical setting in the future.   "
44821|NCT02699047|"     Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty     acids from fish oil concomitant chemotherapy in gastrointestinal cancer.   "
44822|NCT02699034|"     The purpose of this clinical study is to evaluate the and performance of the Imricor Medical     Systems, Inc. (Imricor) MR Ablation Catheter when used with related accessories for the     treatment of type I atrial flutter. The Vision Ablation Catheter and its accessories have     been designed for use under fluoroscopic or magnetic resonance guidance. The study will be a     single center study conducted at the Leipzig University Hospital Heart Center in Germany. The     study population will consist of adult patients requiring ablation for type I atrial flutter.   "
44823|NCT02699008|"     High on-treatment platelet reactivity to adenosine diphosphate was a important reason to     cause ischemic events in antiplatelet therapy. Using single testing to definite HPR may miss     the true HPR or over estimate HPR, which may lead to randomized trials failed. It is not     known whether combined multiple platelet function testing could assist to ensuretureHPR and     improve clinical outcomes.   "
44824|NCT02698995|"     Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a     antiinflammatory steroid. Although the perineural administration is off-label, several     studies recognised its analgetic action as an adjuvant for peripheral nerves blockade,     permitting to reduce the concentration of the local anesthetics and extending the sensory and     motor block.Questions remain concerning the mechanism of action, optimal dose, the     lack/degree of toxicity and the comparison with intravenous administration.The aim of this     prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg     or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical     infraclavicular blockade (VIB) anesthesia for upper limb surgery.   "
44828|NCT02698943|"     Posterior capsule opacification (PCO) and glistenings development is among the primary     reasons for sub-optimal visual capacity following cataract extraction surgery. Primary     objective of this study is to evaluate the incidence of PCO and glistenings of the popular     envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who     underwent phacoemulsification at least 1 year prior to their enrollment at the study   "
44829|NCT02698930|"     Acute kidney injury is major complication after open heart surgery. The cause of acute kidney     injury following open heart surgery is related to activation of sympathetic nervous system,     decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory response.      Infective endocarditis patients undergoing open heart surgery have systemic inflammatory     response associated with infective endocarditis. And the inflammatory response can be     aggravated by cardiopulmonary bypass. The incidence of acute kidney injury following open     heart surgery due to infective endocarditis was 50% in a previous report. And this acute     kidney injury was related to the poor outcome and high mortality. Thus, the preventive method     to protect kidney function will be needed in the patients with infective endocarditis     undergoing open heart surgery.      Dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and CNS depressive     effect. And several experimental study demonstrated the renal protective effect.     Intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed and     suppress the sympathetic response resulted by surgical stimulation. And dexmedetomidine was     reported to reduce the level of serum cortisol, epinephrine and norepinephrine during the     operation. Thus, these effects of dexmedetomidine can be expected to reduce the incidence of     acute kidney injury.      Therefore, the investigators hypothesized that dexmedetomidine has renal protective effect     and this effect might be related to the suppression of inflammatory response. Thus, the     investigators will evaluate the incidence of acute kidney injury after open heart surgery due     to infective endocarditis and the level of inflammatory mediators.      The primary end point of this study is the incidence of acute kidney injury after open heart     surgery due to infective endocarditis. And secondary end point is the level of cystatin C     which is related to the renal function, the level of inflammatory mediator and the     postoperative morbidities.   "
44830|NCT02698917|"     The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility, safety     and effect on brain injury markers of targeting low or high normal arterial oxygen tension     (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose,     mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial     design, participants are randomized at admission to intensive care unit to one of eight     groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this     way, investigators will be assessing the feasibility and effect of all three variables at the     same time.      The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after     cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP     levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG     for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h     after cardiac arrest and neurological assessment at 6 months after cardiac arrest.   "
44831|NCT02698904|"     People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be     exacerbated by psychological outcomes including anxiety and depression. Previous studies     suggest that relaxation techniques may have positive effects on pulmonary rehabilitation. The     main aim of this study is to explore both the respiratory and psychological impact of a     quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary Disease     (COPD).   "
44832|NCT02698891|"     This research study is testing the safety and feasibility of delivering the 4 cycles of     'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte     Colony-stimulating Factor (G-CSF) support. The research study is for participants who have     early stage breast cancer and have been recommended to receive a standard chemotherapy     regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a     dose-dense fashion to prevent recurrences.   "
44834|NCT02698852|"     PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects     from approximately 40 interventional cardiology centers will be enrolled to evaluate the     target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be     followed up to 5 years to attain the data of the secondary endpoints.   "
44835|NCT02698839|"     PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry     trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled     to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the     subjects will be followed up to 5 years to attain the data of the secondary endpoints.   "
44836|NCT02698826|"     The broad objective of this study is to test the association between hyperoxia exposure after     resuscitation from cardiac arrest and outcome. After obtaining written informed consent     subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2)     optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between     subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2     optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after return     of spontaneous circulation (ROSC) is associated with increased oxidative stress and worsened     neurological and cognitive outcomes.   "
44837|NCT02698813|"     The overall goal of this study is to evaluate the safety and exploratory efficacy of the     injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid     for the improvement of wrinkles, acne, pitting scar and so on.   "
44838|NCT02698800|"     Under entrained conditions, humans maintain a consolidated nocturnal sleep episode that     coincides with environmental darkness and endogenous melatonin secretion. Various factors,     such as artificial light, can compromise this temporal harmony, resulting in sleep     disruption. Light is the strongest synchronizer of the circadian clock, with direct inputs     via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms.     Evening light exposure can suppress melatonin secretion and worsen sleep. This is critical,     since most individuals routinely expose themselves to light before bedtime. The high     sensitivity of the circadian system to blue wavelength light indicates that modern light     sources such as light-emitting diodes (LED) may have particularly deleterious effects on     sleep. It is possible to selectively filter out blue light while maintaining other visible     spectra with blue-blocking (BB) lenses. Wearing BB lenses before bedtime may present a     simple, affordable, and safe method to improve sleep. None have yet investigated the effects     of BB lenses on subjective and objective sleep in insomnia patients, while simultaneously     exploring the effects on melatonin secretion.   "
44850|NCT02698618|"     The purpose of this study is to determine whether Ticagrelor has a protective effect on     microcirculation during percutaneous coronary interventions in patients with Diabetes     mellitus type II or in a pre-diabetic status.   "
44851|NCT02698605|"     The usability assessment focuses on the actual use of the proposed rehabilitation system to     clarify issues users would face in actual system operation, thus providing a reference for     subsequent system improvement.   "
44839|NCT02698761|"     Sickle cell disease (SCD) is the most common inherited blood disorder affecting 80,000 to     90,000 individuals in the United States.[10] There are 13,000 hospital admissions for a     sickle cell crises, costing $448 million dollars annually.[10] In our hospital, the sickle     cell population is known to have some of the longest length of stays. Between October 2014     and September 2015, there were 89 admissions for a vaso-occlusive crisis with an average     length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater than     20 days.      We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to     determine if pain and length of stay can be reduced in patients with sickle cell disease. We     also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay     and help with pain. We hypothesize increased physical activity and proper sleep, as     implemented in the CPP, are correlated with decreased hospital length of stay and decreased     pain. Additionally, we believe that creating a standardized nighttime environment at the     hospital will help the children stay in their circadian rhythm thus promoting improved sleep     and a more effective inpatient disease management.   "
44840|NCT02698748|"     One of the proposed ideas for malaria elimination includes the use of drugs to interrupt     malaria transmission by exhausting the human reservoir of infection. Theoretically, mass     treatment of an entire population with a very effective and rapid-acting drug (for instance     an ACT), followed by the administration of an effective prophylactic regime during a minimum     of four weeks, so as to outlast the typical development period of Plasmodium parasites in     Anopheline mosquitoes, could achieve the same objective. In this respect, chloroquine (CQ)     would be an appropriate candidate. This drug exhibits two conditions that make it attractive     for elimination campaigns: 1) It has been demonstrated to have an excellent safety profile,     allowing for its use in all age groups including pregnant women and children; and 2) Its     relatively long elimination half life (t1/2=1-2 months) can provide a long post-treatment     prophylactic effect. Recent evidence suggests that CQ sensitivity may be returning in places     where discontinuation has reduced the drug pressure to the parasite populations. In countries     such as Malawi, P. falciparum seems to have regained full sensitivity to CQ, and molecular     markers of antiCQ resistance have nearly disappeared. While this does not support the     reintroduction of CQ as first line therapy, it does suggest that, if proven sensitive in a     given area, it could play a prophylactic role in malaria elimination strategies when used in     combination with other drugs or tools. Thus, we intend to evaluate the potential role of     chloroquine in preventing infections during elimination campaigns by performing a randomized,     single-blind, placebo-controlled trial in asymptomatic Mozambican adults.      Choosing asymptomatic parasitaemic adult males from a malaria-endemic area as our study     population introduces limited risks when administering a drug with an uncertain efficacy (47%     efficacious in 2001-2002). In malaria-endemic areas, this age group has a remarkably low risk     of developing severe disease (irrespective of clinical symptoms), and it is foreseeable that     parasitemia may be well tolerated, and in certain cases, spontaneously cleared from the     individual's blood as a result of the immune system. In the unlikely event of any clinical     symptomatology appearing throughout the follow-up, individuals will be examined by a study     clinician and treated immediately with the country's first-line malaria treatment     (artemether-lumefantrine, Coartem ®).   "
44841|NCT02698735|"     Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited     skin disease for which there is only supportive care. RDEB is due to mutations in COL7A1 gene     that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs)     mediating epidermal-dermal adherence. Approximately 20% of COL7A1 mutations are nonsense     mutations leading to premature stop codons and a truncated C7 with diminished function. The     investigators demonstrated that aminoglycosides such as gentamicin readily induce premature     termination codon (PTC) read through and produce biologically functional C7 in 22 reported     COL7A1 nonsense mutations. Importantly, aminoglycoside-induced C7 reversed the abnormal RDEB     cell phenotype and incorporated into the dermal-epidermal junction. Herein, the investigators     propose the first clinical trial of gentamicin (topical and intradermal) in RDEB patients     with nonsense mutations that the investigators have fully characterized. The milestones     include increased C7 and AFs at the patients' dermal-epidermal junction, improved RDEB     Disease Activity Score, and absence of significant gentamicin side effects.   "
44842|NCT02698722|"     In the United States, it is estimated that there are approximately 630,000 patients who have     ESRD with two-thirds of those patients subsequently receiving maintenance dialysis. Studies     have demonstrated that the initiation and timing of dialysis for those with ESRD seem to vary     widely regionally - confirming the uncertainty of the benefits of chronic dialysis in this     population      Pre-dialysis education programs inform patients of all of their options allowing them to     choose renal replacement therapy that is most consistent with their wishes. Recent evidence     has supported using different methods of delivering education including videos to complement     standard clinical care practices to promote informed decision making. This proposed study     will serve to examine the effectiveness of a dialysis modality video decision support tool to     inform chronic kidney disease patients of different dialytic and non-dialytic therapies.   "
44843|NCT02698709|"     The main purpose of this study is to determine new diagnostic criteria for an eye disease     called keratoconus.   "
44844|NCT02698696|"     This study evaluates the effect of a new cognitive remediation program designed for patients     suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and     neural processes. In this double-blind (patient, outcomes assessor) controlled randomized     trial the investigators compare patients receiving the ECo program for bipolar disorders, to     patients benefiting from the broadly used cognitive remediation program CRT and to patients     receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9     months.   "
44845|NCT02698683|"     Participants were classified as normal or malnourished according to anthropometric measures.     Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte     count was also recorded on the 1st and 7th days.   "
44846|NCT02698670|"     This is an observational, prospective, non-randomized, multicenter, post approval study being     conducted in the United States, Europe and Asia-Pacific Regions.   "
44847|NCT02698657|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid     arthritis (RA) on methotrexate (MTX).   "
44848|NCT02698644|"     Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate     in occluding uterine tubes of women, which would make it an easy approach for occluding tubes     with hydrosalpinx prior to IVF and in tubal sterilization.   "
44849|NCT02698631|"     The ALICIA-FA study will elucidate whether targeting atrial myocardial fibrosis identified by     late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) improves atrial fibrillation     (AF) ablation outcomes.   "
44853|NCT02698579|"     This is a multi-center, long-term safety and efficacy follow-up study for subjects with     cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in Study ALD-102.      After completing Study ALD-102 (approximately 2 years), eligible subjects will be followed     for an additional 13 years for a total of 15 years post-drug product infusion. No     investigational drug product will be administered in this study.   "
44854|NCT02698566|"     This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients     with neovascular age related macular degeneration or macular edema secondary to retinal vein     occlusion.   "
44855|NCT02698553|"     Bupropion is used in psychological disorder mainly in major depressive disorder (MDD). In     China, buproprion Immediate Release (IR) and Sustained Release (SR) tablet have been in     market for the treatment of MDD. Bupropion Hydrochloride (HCl) Extended Release (XL) tablets     formulation is proposed for marketing approval in China for same indication. Therefore, a     pharmacokinetic study is planned to be conducted in Chinese subjects. It is an open label,     single-centre and single cycle study to evaluate the pharmacokinetics, safety and     tolerability of 150 milligram (mg) and 300 mg following single and repeated daily doses.     Approximately 16 males and females Chinese healthy subjects will be enrolled into the study     to get 12 completed subjects.   "
44856|NCT02698540|"     The purpose is to observe the compliance to a high-calorie, high protein peptide-based     nutritional supplement after 3 months in a malnourished population with impaired     gastrointestinal tolerance living in nursing homes and as outpatients.   "
44857|NCT02698527|"     Objective: To compare pain scores on a visual analogue scale during infiltration of local     anesthetic for vulvar biopsies between women who are treated with buffered versus non-     buffered lidocaine      Hypothesis: Patients treated with buffered lidocaine at the site of vulvar biopsy will have     lower pain scores on a visual analogue scale during the biopsy.      Study Design: Double blinded randomized controlled trial      Population: Women undergoing vulvar biopsy at the Women's Primary Care Center and The Program     In Women's Oncology Clinic of a non-infectious vulvar lesion.   "
44858|NCT02698514|"     The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of     sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.   "
44859|NCT02698501|"     The purpose of this study is to determine whether anti-TSLP will decrease airway     hyperresponsiveness in patients with asthma already on daily treatment with inhaled     corticosteroids.      The investigators expect that airway hyperresponsiveness will decrease after treatment with     anti-TSLP, and that this happens due to a change in the type of mast cells with in the lungs.     Also, the investigators expect a decrease in inflammatory cells and mediators measured in     material from the lungs.      Half of the participants will receive anti-TSLP (MEDI9929) on top of their regular asthma     treatment, while the other half will receive placebo on top of their regular asthma     treatment.   "
44910|NCT02697825|"     This study involves observing and comparing Intraocular Pressure and Optic Nerve Sheath     Diameter in steep trendelenburg position. Both observations will be done in same patient over     the surgical duration.   "
44860|NCT02698488|"     Identification of the embryo with the highest potential to implant and establish an ongoing     pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day     by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The     optimal scenario is the transfer of a single embryo which gives rise to a singleton     pregnancy. The current limitations in determination of embryos that have the highest     implantation potential probably contribute to the low rates of pregnancy during IVF     treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a     'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it     provides a chance to evaluate them from the oocyte stage all the way to the blastocysts     stage. Hence, in the first era of IVF, there were number of studies that evaluated this     parameter and associated morphology with IVF success rates. On the other hand, it has been     previously stated that the slight increase in pregnancy rates during IVF treatment is mostly     likely a result of better practices in laboratory than morphological evaluation. Due to the     limitations of morphological evaluation, several researchers have investigated adjunctive     non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.      Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples     needed minimal preparation; analytical analysis was rapid and large amounts of data was     available. Hence, MS might be a promising approach for metabolomic profiling of embryo     culture media.   "
44861|NCT02698475|"     The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric     participants aged greater than or equal to (>=) 6 through less than (<) 12 years with     moderate to severe chronic plaque psoriasis   "
44862|NCT02698462|"     The aim of this study is to identify more persons with advanced neoplasia in the current     national CRC screening, by adding data on family history of CRC (using a validated online     questionnaire) to FIT. In addition, the aim is to identify those persons and their family     members who should not be participating in a FIT based screening but receive surveillance     colonoscopies instead, because of a familial CRC syndrome. It is aimed to increase detection     without affecting participation, thereby increasing the yield of screening.   "
44863|NCT02698449|"     The current study aims to better understand cerebral plasticity mechanisms to optimize     non-pharmacological rehabilitation approaches for patients with traumatic brain injury.   "
44864|NCT02698436|"     This study will compare two different acne treatments for the treatment of acne. Half of the     participants will receive two marketed acne products (cleanser and leave-on topical     treatment), while the other half of the participants will receive a marketed cleanser and a     light-therapy device.   "
44865|NCT02698423|"     The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling     can be used as a primary screening test for unscreened women.   "
44866|NCT02698410|"     The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg     in combination with Temozolomide in subjects with unresectable advanced neuroendocrine     tumours of the lung or thymus as Disease Control Rate at 9 months.   "
46222|NCT02680587|"     Men with oligometastatic prostate cancer lesions will be randomized (1:2) to observation     versus SBRT. The study will NOT be blinded. Within three weeks of the initial treatment     planning, SBRT (1-5 fractions) will be administered.   "
44867|NCT02698384|"     The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor     size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for     starting alternative strategies, and to describe the modalities and the global effectiveness     of alternative strategies.   "
44868|NCT02698371|"     The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in-one     Self-Etch (Futurabond® DC (FBDC)) adhesive and multimode/universal (Futurabond® U (FU) and     Adhese® Universal (AU)) adhesives, with or without selective enamel etching, in non-carious     cervical lesions (NCCL), during 24th months, using Word Dental Federation (FDI) and United     States Public Health Services (USPHS) criteria.      The null hypotheses are:      H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in     similar (no significant differences) clinical (aesthetic, functional and biologic)     behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with DC-SE     and SE-Universal adhesives with SE strategies will result in similar restorations (aesthetic,     functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with     DC-SE and SE-Universal adhesives with SE strategies will result in similar restoration     retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel     pre-etching and Universal adhesives with ER adhesive strategy will result in similar (no     significant differences) clinical (aesthetic, functional and biologic) behaviour/performance     in a period of 24thmonth evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and     Universal adhesives with ER adhesive strategy will result in similar restorations (aesthetic,     functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs     DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result     in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to     NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive     strategies will result in similar (no significant differences) clinical (aesthetic,     functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 -     Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER     adhesive strategies will result in similar restorations (aesthetic, functional and biologic)     success rates over 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC     adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in     similar restoration retention rates in a period of 24th month evaluation; H0 - FDI or USPHS     criteria evaluation outcomes not differ for the same data.   "
44869|NCT02698358|"     -  Prospective, single-arm, multi-center registry study        -  A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion          criteria will be included.        -  Patients will be followed clinically for 12 months after the procedure.        -  Duplex ultrasound, CT or catheter-based angiography follow-up according to participating          hospital's protocol will be performed at 12 months.        -  Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12          months.        -  Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)   "
44870|NCT02698345|"     -  Prospective, multi-center, single-arm registry study        -  A total of 100 subjects with isolated popliteal artery lesions according to inclusion          and exclusion criteria will be enrolled.        -  All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral,          Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting          balloon is allowed • Patients will be followed clinically for 12 months after the          procedure.        -  Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will          be performed at 12 months.   "
44871|NCT02698332|"     The aim of this study is to investigate the effect of diagnostic algorithm for urinary tract     infection (UTI) on appropriate prescribing of antibiotics and use of diagnostics for patients     with symptoms of urinary tract infection consulting their general practitioner.      70 general practices participating in an observational study regarding UTI are randomized to     either receiving a diagnostic algorithm or not receiving anything additional.      The study is observational on the patient level and interventional on the practice level.   "
44872|NCT02698319|"     Crowding in the emergency department (ED) is a well documented problem putting patients at     risk of adverse outcomes. To combat this, most ED's use some form of triage. In the last two     decades systematic triage or process triage has become the norm in most countries but this     approach is supported by limited evidence. Our aim is to develop a faster triage model of     only a few vital parameters, based on a data from a large cohort of unselected ED patients     and evaluate if such a model combined with a clinical assessment by the ED nurse is inferior     to existing triage models in a prospective cluster-randomized trial   "
44873|NCT02698306|"     The investigators will select 30 patients with symmetrical impaction of third molars,     according to Pell and Gregory dental impaction classification, who would be submitted to two     surgical procedures, right and left, and in both surgeries dexamethasone 8 mg was     administered in the pre-surgery phase, and the use of dexamethasone (12 mg/day) for 3 days on     one side and diclofenac sodium (150 mg/day) for 3 days on the other side was continued, in a     randomized, double-blind and cross-over trial so that all patients acted as control of     themselves (split-mouth). Other drugs used in postoperative period, rescue analgesic and     antibiotic therapy will be identical for all patients. The analyzed variables will be the     visual analogue pain scale (VAS), total number of consumed analgesics, swelling and trismus     (objectively), which were statistically analyzed by means of Student's t-test.   "
44874|NCT02698293|"     This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of     patients with pre-malignant tumors and superficial microinvasive disease of the anal canal     and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer     Gliolan orally followed by the administration of red light (629-635 nm) to the tumor from a     laser. The dose of Gliolan will be 40 mg/kg administered approximately 4-6 hours before light     administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients in     each. Patients will be observed for 30 days for the development of DLT. Patients will be     followed up for 24 months for additional toxicity and efficacy data collection.   "
44875|NCT02698280|"     The purpose of this study is to determine whether bevacizumab and nimustine are effective in     the treatment of recurrent high grade glioma and to explore whether there is any subgroup     being sensitive to this therapeutic protocol.   "
44876|NCT02698267|"     The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4     inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study     are to assess the safety and tolerability of BIIB074 when co-administered with a strong     CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of     BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).   "
44877|NCT02698254|"     The goal of this clinical research study is to test the safety of repeat radiation for brain     tumors that came back after the first course of radiation. Researchers also want to learn how     repeat radiation affects your quality of life.   "
44878|NCT02698241|"     The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only),     investigational, feasibility study. The purpose of this study is to characterize safety of     managing heart failure patients with integrated device diagnostics that have an implanted     commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).   "
44879|NCT02698228|"     The goal of the RAPID study is to fundamentally transform the way serious injuries are     managed after earthquakes and other disasters by introducing a novel and cost-effective     method for pain control. The study will enroll patients in the aftermath of a major     earthquake to determine whether regional anesthesia, either with or without     ultrasound-guidance, can reduce suffering from lower limb injuries, the most common     earthquake-related injury, above and beyond the current standard of care for pain control in     these settings.   "
44880|NCT02698215|"     This study is a double-blind, randomized clinical trial using a two group medication design     consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1     mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking     daily smokers who want to quit smoking and reduce drinking.   "
44881|NCT02698202|"     Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D     Digital Mammography only in respect to incidence of advanced cancers (interval and following     round) and interval cancers.   "
44882|NCT02698189|"     This is a study to determine the recommended dose of MK-8628 for further studies in     participants with acute myeloid leukemia (AML) including AML de novo and AML secondary to     myelodysplastic syndrome (MDS) and in participants with diffuse large B cell lymphoma     (DLBCL). The recommended dose will be established by evaluating dose limiting toxicity (DLT),     safety, tolerability, and early efficacy signals.   "
44883|NCT02698176|"     This is a study to determine the recommended dose of MK-8628 (formerly known as OTX015) for     further studies in participants with advanced nuclear protein in testis (NUT) midline     carcinoma (NMC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), or     castration-resistant prostate cancer (CRPC). This is a two-part parallel study: Part A will     establish the recommended dose by evaluating dose limiting toxicity (DLT), safety,     discontinuation, and early efficacy and Part B will enroll participants with NMC only and     will evaluate safety and efficacy in this population.   "
44884|NCT02698163|"     Non-surgical root canal therapy (RCT) represents a standard of treatment that addresses     infected pulp tissue in teeth and protects against future infection while preserving the     tooth for the patient for mainly cosmetic purposes. RCT is offered as the better cosmetic,     cheaper, and less time intensive treatment option for a patient compared to those of dental     implantation. Dental implantation is the alternative to RCT, and they are both originally     offered at the time of the initial consultation. RCT involves non-surgically removing dental     pulp comprising blood vessels and nerve tissue, decontaminating residually infected tissue,     and using a filler material to replace the non-surgically created space where the pulp was     removed. Currently, standard of care treatment for RCT utilizes gutta-percha as the root     canal filling material. Our research group has previously demonstrated NDGP's improvement in     tensile strength compared to those of gutta-percha. This research studies a new type of     filler, gutta-percha modified by the addition of nanodiamond material (NDGP). This is an     equivalence study of NDGP and standard gutta-percha administration.   "
44885|NCT02698150|"     HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients     with severe functional mitral regurgitation undergoing transcatheter mitral valve     edge-to-edge repair with the Mitraclip system.   "
44886|NCT02698137|"     The investigators will prospectively collect patient and procedure-related data in an     observational study in order to detect patient and procedure-related risk factors for poor     outcome (i.e. technical failure of the procedure; procedure-related complications).      Data will be prospectively reported using standard report forms and patients will be followed     up to 30 days to detect late-onset complications.   "
44888|NCT02698111|"     The investigators do the clinical trial (patients with metastatic nasopharyngeal carcinoma     treated with donafenib after failure of standard therapy) to assess safety and efficacy of     donafenib in patients with metastatic nasopharyngeal carcinoma, progressing after all     approved standard therapies.   "
44889|NCT02698098|"     This observational study compares the health and social outcomes between opioid-dependent     individuals who are either recently released from a compulsory drug detention center (CDDC)     or recently discharged from a voluntary treatment center (VTC) providing methadone     maintenance therapy, in Malaysia.   "
44890|NCT02698085|"     Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the     neuromusculoskeletal system. In the clinical practice a favorable effect is observed in     patients with carpal tunnel syndrome, but there is no published studies evaluating the     results os this technique.      The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in     symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a     placebo.      For this purpose the investigators conduct a randomized controlled trial double-blind     (patient and examiner). The investigators included patients diagnosed of carpal tunnel     syndrome (low to moderate intensity) with a neurophysiological test.      Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the     other placebo. Both groups receive 5 treatment sessions.      The variables are measured at the beginning and end of treatment. And also some variables are     measured before and after each session. Patients who participated in placebo group, when the     intervention finish the investigators will be given the opportunity to receive the actual     technique   "
44891|NCT02698072|"     This study evaluates the combination of a therapeutic exercise program and dry needling in     the treatment of knee osteoarthritis in older adults. Half of participants will receive     therapeutic exercise program and dry needling in combination, while the other half will     receive the same therapeutic exercise program and sham dry needling.   "
44892|NCT02698059|"     This is a post-marketing surveillance study to investigate the efficacy and safety of the     Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.   "
44893|NCT02698046|"     This study is design to evaluate the effectiveness of oral iron therapy in patients with     heart failure and identify the central and peripheral mechanisms involved in the improvement     of functional capacity after intervention. The investigation includes subjective and     objective measures on exercise performance and heart function after intervention, and the     tolerability of oral iron treatment.   "
44902|NCT02697929|"     Cirrhotic patients undergoing liver transplantation are at very high risk of post operative     complication such as post-operative residual curarization.      Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly     antagonized with sugammadex.      No one study compared sugammadex versus neostigmine after rocuronium infusion during liver     transplantation.   "
44918|NCT02697721|"     The purpose of this study is to examine if a psycho-educational intervention for caregivers     of patients with dementia will decrease caregiver burden, increase caregiver physical     activity, and decrease the reporting of behavioral and psychological symptoms of the person     with dementia.   "
44894|NCT02698033|"     This protocol is designed to better characterize a sub-population of peanut sensitized     individuals who may be non-allergic, despite significant sensitization, or who may be     allergic, but at high threshold doses. By specifically targeting participants who met the     initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC     MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut,     the investigators anticipate that the investigators will identify individuals who have become     spontaneously tolerant, despite persistent sensitization. The investigators might also find     that clinical sensitivity persists but only with higher thresholds, or that sensitivity has     increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through     to a full serving dose (7.4 gram), the investigators will distinguish participants who react     only at higher doses from those who were not truly peanut allergic, address whether their     sensitivity has changed, and have the opportunity to further investigate their immune     response to peanut allergen.   "
44895|NCT02698020|"     An open randomized control trial investigating the delivery of two levels of inspired oxygen     to newborn infants during general anesthesia.   "
44896|NCT02698007|"     Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung     recognized for many years.      Since the action takes place in the airways and in light of the use of sedation, when     performing, the procedure requires caution to keep potent airway and breathing sufficient     enough.      Most of the bronchoscopy done without the aid of equipment for advanced airway protection.     During the operation done monitoring hemodynamics: such as blood pressure, pulse and     respiratory such as percutaneous oxygen saturation and carbon dioxide.      Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of     airway respiratory activity during positive-pressure ventilation.      Several studies have shown that the use of LMA is a convenient and safe while performing     bronchoscopy for airways and lungs. However, most of the studies were for certain patient     groups such as children, immuno-compromised patients.      Or benefits and safety LMA in front of intubation during bronchoscopy.      Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients     undergoing flexible elective bronchoscopy .      Another objective, to examine whether there is a special group of patients enjoy the LMA more     than others.      Patients will be divided randomly into two groups alternately by order, one patient study     group and the next one to control.      Study group : LMA is inserted under sedation and used during the procedure.      Control group - performing bronchoscopy under sedation without LMA.      About 50 people are needed each group.   "
44897|NCT02697994|"     ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33%     of women, continuous and severe back pain is observed. In management of this pain, sterile     water injection is considered to be an effective method. Aim of this study is assessment of     effectiveness and satisfaction of this method among Turkish women in which analgesic methods     are not extensively used in labour and rates of cesarean section exponentially increases.      Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim     Training and Research Hospital with labour pain and had severe back pain were randomized into     4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis     Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and     180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia,     APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding     scores were assessed.   "
44930|NCT02697552|"     Phase 1, open-label, non-randomized, dose-escalation study to evaluate the safety,     tolerability, pharmacokinetics (PK), and preliminary efficacy of HBI-8000 administered     orally.   "
44898|NCT02697981|"     Background: Nutrition challenges follow bariatric surgery can intensify during pregnancy and     may have a crucial effect on fetus. To the best of the investigators knowledge, the effect of     nutritional counseling on improvement of maternal diet quality and eating habits among post-     bariatric pregnant women has not been evaluated.      Objective: study aims to expand the existing limited knowledge in respect to post bariatric     pregnant women's eating habits and quality of food intake, and to investigate the impact of     nutrition counseling on these factors.      Design: This is a controlled clinical trial comparing post Laparoscopic sleeve gastrectomy     (LSG) pregnant women who received nutritional counseling with age-matched control healthy     pregnant women. Counseling will focus on improving quality of food consumption, eating habits     and behavioral changes in order to improve the mother and the fetus' nutritional status     Nutritional data and eating behavior will be obtained using 24 hours recall dietary records     and the Family Eating and Activity Habit Questionnaire (FEAHQ).   "
44899|NCT02697968|"     Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3     times higher than general population. Conventional approaches for AS have their limitation.     Previous studies demonstrated acupuncture has significant therapeutic effects for AS in     diminishing joint pain, enhancing functional disorders and modifying spinal deformity.     Although acupuncture is effective in relieving pain in AS patients, the evidence is very     limited due to methodological flaws.      Design This study will be a single-arm pilot study in patients with AS. Eligible subjects     will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in     total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in     total) if participants request a prolonged treatment. The acupuncturist, who is a registered     Chinese medicine practitioner, of this trial will not participate in data collection and data     entry.      Objective: To explore the treatment effect of electroacupuncture for relieving pain in     ankylosing spondylitis.      Setting: Hong Kong      Participants: 20 subjects with a diagnosis of ankylosing spondylitis      Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events      Data analysis All data will be double-entered and checked for consistency before conducting     the analysis. Binomial test will be used to analyze the percentage of responders to treatment     compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the     values of all continuous variables between baseline and post treatment. The population for     safety analyses will include all subjects who receive at least one acupuncture treatment.     Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special     attention will be given to those subjects who have discontinued treatment due to adverse     events or who experience serious adverse events.   "
44900|NCT02697955|"     The study investigates the effect of a ultrasound-guided subsartorial saphenous block on     postoperative pain following major ankle and hind foot surgery.   "
44901|NCT02697942|"     This will be a pilot, single center, randomized, controlled trial to slow cognitive decline     in adults undergoing hemodialysis (HD). The investigators will test two interventions     (cognitive training and exercise training) against the standard of care.   "
44917|NCT02697734|"     Purpose of study is to aim to confirm efficacy and safety of osilodrostat for the treatment     of patients with Cushing's disease who are candidates for medical therapy   "
44903|NCT02697916|"     ADAPTABLE is a pragmatic clinical trial in which 20,000 patients who are at high risk for     ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81     mg/day vs. 325 mg/day. Study participants will be enrolled over 24 months. Maximum follow-up     will be 30 months. The purpose of the study is to identify the optimal dose of aspirin for     secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The     primary endpoint is a composite of all-cause death, hospitalization for MI, or     hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding     with an associated blood product transfusion.   "
44904|NCT02697903|"     From the recent scientific literature in the field of biological response to physical     exercise, a significant increase in muscle damage, soreness and inflammation were registered     immediately and even 48 after resistance exercise. In the other hand, from the recent     scientific literature in the field of nutrition it is well established that Pomegranate juice     is a potent antioxidant that can help prevent or treat various disease risk factors. However,     only few studies associated the effect of the pomegranate with the physical exercise. To the     authors' knowledge, there are no studies investigated the acute and delayed effect of     pomegranate supplementation in performance and muscle recovery after exercises involved     muscle of whole body. Therefore, the aim of the present study was to investigate the effect     of natural Pomegranate juice supplementation on the acute and delayed response of muscle     soreness and biochemical parameters following weightlifting training session   "
44905|NCT02697890|"     The objective of this study is to evaluate clinically and radiographically the effect of     Mucograft® seal when used for the ridge preservation procedure in combination with Freeze     Dried Bone Allograft (FDBA) at the extraction site in terms of hard and soft tissue     remodeling after 4 months healing period.   "
44906|NCT02697877|"     The aim of this study is to assess whether myocardial perfusion reserve, measured during     routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has prognostic     value in predicting adverse cardiovascular events. Myocardial perfusion reserve will be     measured with CMR by assessing blood flow through the coronary-sinus - the primary vein in     the heart.   "
44907|NCT02697864|"     3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for     each test and every subject will test all 3 different formulations. After swallowing     tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14     days, subjects will take a different formulation of tafamidis and tafamidis blood     concentrations will be measured periodically for 6 days. After another 14 days, the last     formulation will be tested in the same way.   "
44908|NCT02697851|"     This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and     microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There     will be two study arms, who will take the medications in different orders:      GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for     14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days     wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by     Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total     duration of the study is 57 days (+screening and follow up visits) and patients will have 3     intensive pharmacokinetic days on days 14, 35 and 56.   "
44909|NCT02697838|"     A single arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric     cancer which paclitaxel-resistant.   "
44911|NCT02697812|"     In North America, almost ½ million people undergo coronary artery bypass graft surgery     annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac     surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus     standard-of-care (sternal opening over 30 seconds) and examine the incidence and severity of     chronic post-sternotomy pain (CPSP) and quality-of life 3, 6 and 12 months post-operatively.     The severity of acute post-operative pain will also be measured. Increased retraction time     reduces forces required, which should translate to reduced nerve/tissue damage. If effective,     this simple change in practice could be readily implemented with a major impact for patients     and the health care system overall.   "
44912|NCT02697799|"     In a multicenter, randomized clinical trial of attitudes towards research participation, we     will evaluate the ethics, effectiveness, and cost- effectiveness of three recruitment     strategies for research participation in in a radiation therapy study among patients with     lung cancer, a mobility trial among hospitalized patients, and a smoking cessation trial     among patients with depression.   "
44913|NCT02697786|"     Postoperative brain damage and neuropsychological disorders have been observed in 30 - 80 %     of patients after heart surgery with the use of cardiopulmonary bypass (CPB).They can persist     up to a year after cardiac surgery and are associated with increased hospital mortality and     prolonged intrahospital stay.      Hypoperfusion,hyperthermia,atrial fibrillation,genetic predisposition and systemic     inflammatory response associated with CPB have been identified as pathophysiological     mechanisms.However, some authors consider cerebral embolisation to be the prevalent mechanism     of intraoperative brain injury after cardiac surgery,as gaseous or solid cerebral emboli can     cause ischemia, inflammation and edema,consequently causing cerebral infarctions usually     resulting with stroke,coma,encephalopathy, delirium and cognitive decline. Additionally,they     may impair cerebrovascular reactivity (CVR).      Aortic valve replacement (AVR) preformed by full sternotomy is the standard approach in the     treatment of aortic valve disease. Minimally invasive (MIS) aortic valve replacement has been     shown to reduce postoperative mortality, morbidity, and pain while providing faster recovery,     a shorter hospital stay, and better cosmetic results. However, due to technically more     demanding procedure, MIS may lead to prolonged CPB time and incomplete de-airing of the heart     with an increased risk for cerebral gas embolization. Therefore, the choice of MIS might bear     an augmented risk for brain injury.      Transcranial Doppler (TCD) enables real time detection of intraoperative emboli in the     cerebral arteries seen as microembolic signals (MES), and is an essential neuromonitoring     tool. Several studies demonstrated correlation between the number of MES and the occurrence     as well as severity of postoperative neurological complications. However, the factors     contributing to brain injury have not been elucidated in those studies. The investigators     speculate that impairment of CVR is an important mechanism that persists and prolongs the     duration of brain injury into postoperative period.      The aim of the study is to compare two surgical approaches used for AVR, with focus on the     number of MES and their impact on levels of protein S100B (marker of brain tissue     damage),postoperative CVR and cognitive function With the results,the investigators aim to     help surgeons in selecting the appropriate technique for AVR in individual participants,as     well as to clarify the effect of aortic valve surgery on the brain.   "
44915|NCT02697760|"     To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging     with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart     disease.   "
44916|NCT02697747|"     The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4     interspace will improve resident's long term skill to correctly identify the interspace as     compared to palpation alone.   "
44919|NCT02697708|"     This study is designed to compare the effect of different dietary potassium sources on uptake     and retention of potassium, as well as to determine the effect of potassium intake on blood     pressure and acid-base balance. The study will compare three different sources of potassium     given as a supplement, potatoes or French fries.   "
44920|NCT02697695|"     To evaluate the impact of obesity surgery on chronic inflammation.   "
44921|NCT02697682|"     To investigate the feasibility and short term safety issues of treatment of knee     osteoarthritis with intra-articular injection with the stromal vascular fraction of abdominal     adipose tissue (SVF) harvested and prepared using the Lipogems System.      Hereby we wish to pave the road for a high quality randomized controlled trial investigating     effectiveness of treatment of knee osteoarthritis with SVF looking at patient reported     outcome, function, homeostasis of the joint and cartilage regeneration.   "
44922|NCT02697669|"     Heart failure is a clinical syndrome of exercise intolerance and/or congestion. The potential     roles of myocardial perfusion and metabolic abnormalities in subjects with cardiovascular     risks, metabolic disease and heart failure assessed by nuclear dynamic imaging warrant     further investigations. The study investigators propose that microvascular dysfunction and     abnormal metabolic substrate shift precedes and triggers the onset of diastolic dysfunctions.     The aims are (1) to develop and validate the noninvasive measurement of absolute myocardial     blood flow (MBF) and myocardial flow reserve (MFR) by using dynamic imaging with a CZT     camera, (2) to assess myocardial glucose metabolism by using 18F-FDG dynamic PET, and MBF,     MFR and LV systolic and diastolic function by dynamic SPECT comprehensively in subjects at     cardiovascular risks and metabolic disease, HFrEF and HFpEF, (3) to correlate with peripheral     serum markers and blood mononuclear cells subsets with myocardial perfusion and metabolic     abnormalities, and (4) to test the hypothesis of these imaging and blood markers in diagnosis     and prognostic implications. The study investigators also assess myocardial metabolic     utilization in healthy and mice model of different metabolic disorders (obesity, diabetes     mellitus and hypertension) by using 18F-FDG dynamic micro PET/CT, as an in-vivo measures     which could be used to better understanding the disease mechanism and evaluating therapeutic     strategies.   "
44931|NCT02697539|"     This 12-week prospective, randomized, double-blind, two-center trial evaluated the impact of     a microcrystalline zinc-hydroxyapatite (mHA) dentifrice on plaque formation rate (PFR) in     periodontitis patients. The investigators hypothesized that mHA precipitates cause delayed     plaque development when compared to a fluoridated control (AmF/SnF2), and therefore would     improve periodontal health.   "
44923|NCT02697656|"     Individual Placement and support (IPS) is an evidence-based approach originally developed to     help people with severe mental disorders to obtain and maintain employment. The effectiveness     of IPS for patients with severe mental illness is well documented, but has never previously     been tested for patients with chronic pain. In fact, employment support is rarely provided in     pain clinics, despite an increasing focus on integrating work and health in all patient     treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as     an integrated part of the interdisciplinary treatment for patients with chronic pain in a     hospital outpatient clinic.   "
44924|NCT02697643|"     For behavioral health clinicians who are interested in getting tailored treatment and level     of care recommendations, BH-CDS is a desktop/tablet web-based application that provides     clinicians with data and a rationale for better decision-making to improve patient care.      Few Clinical Decision Support (CDS) systems are available for Behavioral Health, and unlike     existing CDS this product will compile relevant patient data and organize these data into     general treatment recommendations linked to the patient's presenting circumstances, symptoms     and substance use issues.      The BH-CDS solution shall factor patient characteristics into a Latent Class Analysis (LCA)     that will group patients according to their responses with other patients with similar     responses (i.e., a subgroup or class). Once patients have been assigned to a class, the     solution shall present recommendations to counselors that use the software.   "
44925|NCT02697630|"     The purpose of this study is to see if the combination of entinostat and pembrolizumab can be     an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread     to other sites of the body (metastatic disease). Pembrolizumab is an antibody that helps the     immune system to attack cancer cells. Although pembrolizumab has proven clinical efficacy in     treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma     has not been established. Entinostat is a histone deacetylase (HDAC) inhibitor that has     effects on both cancer cells and immune regulatory cells, thus potentially enhancing the     effects of immunotherapy.   "
44926|NCT02697617|"     Funding Source - FDA OOPD      Pioglitazone is currently used in clinical practice to treat diabetes and this study will     examine the potential use of a low dose of the same drug for the treatment of polycystic     kidney disease. The purpose of this study is to determine whether the diabetes drug     pioglitazone (Actos) is a safe and effective treatment of autosomal dominant polycystic     kidney disease when treated in its early stages. Pioglitazone is approved by the FDA for the     treatment of diabetes. Pre-clinical models of polycystic kidney disease have shown that low     dose treatment with pioglitazone decreases the growth of the cysts. The studies also suggest     that effective pioglitazone dosing for polycystic kidney disease may be lower than that used     to treat diabetes. The purpose of this study is to see if pioglitazone might slow cyst     disease in humans.   "
44927|NCT02697591|"     This is an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in subjects with     advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine     the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will     further evaluate the recommended dose determined in Part 1 in subjects with select tumor     types.   "
44955|NCT02697227|"     The goal of this research study is learn if Behavioral Activation Treatment (BATS) or Health     Education/Smoking Cessation counseling (HE), combined with the nicotine patch, can help     people with different types of emotion and attention levels quit smoking.   "
44968|NCT02697058|"     Study Part 1: To assess the safety and tolerability, and to characterize the pharmacokinetics     (PK) of BAX2398 in combination with 5-FU/calcium levofolinate in Japanese patients.      Study Part 2: To compare the efficacy of BAX2398 in combination with 5-FU/calcium     levofolinate versus 5-FU/calcium levofolinate as assessed by Progression Free Survival (PFS)     using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).   "
44928|NCT02697578|"     In hemodialysis patients, deviations of serum concentration of calcium, phosphate or     parathyroid hormone from the values recommended by KDIGO are associated to a negative     outcome. The regulation of calcium, phosphate and parathyroid hormone is complex and each     parameter is not independently regulated. In hemodialysis patient's simultaneous modification     in these three parameters are the result of abnormal mineral metabolism and the treatment     used to correct these abnormalities that usually produce changes in more than one parameter.     The specific objective of this work is an accurate and exhaustive analysis and description of     the complex relationships between clinically relevant parameters in chronic kidney disease     metabolism bone disease. In order to achieve these objectives we have used a machine learning     approach Random Forest able to extract useful knowledge from a large database. The analysis     of the complex interactions between the different parameters needs an advance mathematical     approach such as Random Forest . The second aim of this study is to determine whether     calcium, phosphate and parathyroid hormone, Fibroblast growth factor 23 and calcitriol are     long-term associated with demographic features, mortality, co-morbidity and the therapy     prescribed. Compare the predictions obtained with conventional statistical analysis versus     the new model analysis based on artificial intelligence. Our preliminary results suggest that     there are interactions between some parameters that are strong enough to question whether the     evaluation of a given therapy can be based in the measurement of one single parameter.     Subsequently, we will analyze in a prospective study on incident patients, whether the use of     this new model may predict the cardiovascular risk and reduce the therapy cost.   "
44929|NCT02697565|"     One in four U.S. children under the age of 5 years old are either overweight or obese with     ethnic-minority children being disproportionately affected. Low-income preschool children,     many from ethnic minority backgrounds, receive childcare in federal/state subsidized centers     where daily meals are provided. Nationally, the Quality Rating and Improvement Systems (QRIS)     organization is responsible for rating the quality of childcare centers. However, nutrition     and physical activity policy standards have not been incorporated into QRIS childcare center     policies. Therefore, the goal of this project is to address the 2014 AFRI program area     priority of Childhood Obesity Prevention by building on the phase I Healthy Caregivers,     Healthy Children (HC2) NRI/AFRI funded project (2010-2013), in partnership with the Miami     Dade County Cooperative Extension team, to evaluate the program via randomized-controlled     trial outcomes, and deliver an evidence-based effective childcare center-based     program/toolkit. This project (phase II) will expand HC2 Phase I findings by transferring the     evidence-based HC2 program/toolkit to QRIS childcare centers via a train-the-trainers (TTT)     model. The following specific aims are proposed; (1) to evaluate the TTT model of delivery     for the evidence-based HC2 toolkit's effectiveness versus an attention control on parent and     teacher adoption of healthy lifestyle role modeling behaviors, and policy integration; (2) to     evaluate the impact of a TTT delivery model versus an attention control on child body     composition and short- and long-term behavioral health outcomes, and (3) to disseminate the     HC2 early childhood obesity prevention toolkit TTT model within the QRIS early childhood     network at the Miami Dade County-level.   "
44933|NCT02697513|"     Infection and sepsis are among the leading causes of death worldwide, particularly in middle-     and low-income countries.The Surviving Sepsis Campaign has launched an initiative to improve     sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. In     this prospective before-after study, three interventions will be performed: First four months     period: collection of baseline data on the clinical management of patients with acute     infection. Second four months period: During the first days, a 1.5-day focused training     program will be performed (participants: health care workers of primary care facilities     within the catchment area of the Gitwe hospital and health care workers of the Gitwe     hospital). Then, a simple management protocol to care for patients with an acute infection     will be implemented into clinical practice. During the third four months period, a 'Sepsis     First Aid' kit containing essential resources to treat patients with an acute infection     (antimicrobials, fluids, data documentation sheet) will be distributed to primary care     facilities and the emergency department of the Gitwe hospital. During the 8 months following     the focused training program (periods 2 and 3), data collection will continue. It is     hypothesized that implementation of a simple clinical management protocol and exposure of     health care workers in the Gitwe Hospital area to a focused training program on the     management of acute infections will increase the rate of evidence-based interventions     performed in patients with an acute infection during the first six hours after hospital     admission (administration of oxygen and fluids whenever indicated, timely administration of     antimicrobial drugs, source control measures).   "
44934|NCT02697500|"     This study evaluates how blood serum handling conditions can affect the concentrations of     ~1,000 serum metabolites and attempts to quantify the degree of attenuation and/or potential     bias in epidemiologic associations that may result from less than optimal sample handling     conditions.   "
44935|NCT02697487|"     This is a longitudinal observational study (via electronic records and biospecimens) designed     to utilize health IT advances to collect information from patients undergoing routine care.     This information will be stored in a database. Patients undergoing routine care from their     providers will be invited to participate in the UTSW Depression Cohort. After obtaining     informed consent, the CDRCC team will collect information from available sources and store it     in a secure UT Southwestern network database protected by a security firewall. A schematic     representation of this information processing is shown in the figure contained in section 3     of the protocol. As part of the UTSW Depression Cohort, patients will allow banking of their     specimens. Specimens which are banked may include blood or blood products, urine, tissue     samples, saliva, stool samples or clinical waste products. The study will only enroll     participants comfortable with providing specimens. As the goal of the UTSW Depression Cohort     is to create a national database, CDRCC will engage with patients, providers, and researchers     at local, regional, and national levels. A large number of medical providers are already     screening patients for depression. Structured instruments like PHQ-2 or PHQ-9 are often used.     Hence, the CDRCC will seek collaborations with local, regional and national partners so that     information contained in their health IT initiatives can be included in the this database.     Due to the clinical nature of information collected, the investigators anticipate marked     heterogeneity in the variables and amount of data collected. Database architects will utilize     big data (large volumes of information from diverse sources with variable degrees of quality     and complexity) tools to structure the registry so that additional variables can be added, as     needed. The CDRCC team will maintain a detailed codebook of variables collected in the     database. All statistical analyses will be conducted only on de-identified data. Researchers     may obtain access to this de-identified data by following procedures established by the     CDRCC, which include obtaining IRB approval.   "
44969|NCT02697045|"     Nautralsitic, Open-label, Single Arm, Uncontrolled Study Evaluating the Effects of Long     Acting Injectable (LAI) on Phychosocial Functioning Congitive Functioning and Patient     Reported Acceptability of Treatment 'Reported Acceptability of Treatment' Regarding Quality     of Life Subjective Well-being Under Neuroleptic Medication in Schizophrenia Patients   "
44936|NCT02697474|"     The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of     age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also     evaluate the immune response against hepatitis B one month after vaccination (challenge     vaccination) with a stand alone monovalent hepatitis B vaccine.      Primary objectives:        -  To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after          last priming dose in subjects having received hepatitis B vaccine at birth and a          hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during          A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2])        -  To evaluate the immune response against hepatitis B one month after vaccination with a          stand alone monovalent hepatitis B vaccine (challenge vaccination).      Secondary objectives:        -  To describe serious adverse events (SAEs) reported throughout the trial after          administration of hepatitis B vaccine.   "
44937|NCT02697461|"     Lateral ankle sprains (LAS) and chronic ankle instability (CAI) are common musculoskeletal     injuries that are a result of inversion injury during sport. The midfoot is frequently     involved during inversion injury, is often overlooked during clinical examination, and maybe     contributory to the development of CAI. The purpose of this study is to investigate     multisegmented foot motion using a motion capture system, clinical joint physiological and     accessory motion, and morphologic foot measurements in recreationally active men and women     with and without a history of lateral ankle sprains and chronic ankle instability.     Additionally, the effects of a joint mobilization intervention in patients with diminished     multisegmented foot motion and intrinsic foot strengthening in healthy individuals will be     investigated.   "
44938|NCT02697448|"     Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial     fibrillation   "
44939|NCT02697435|"     Back pain is a huge problem for millions of Americans, including nearly 11 million Veterans.     Our older Veterans suffer the most. Citizens spend billions of dollars, yet consistently get     poor results. Primary Care Providers are often tasked with diagnosing and treating Chronic     Low Back Pain, even though they are often undereducated in the field. These PCPs often use     advanced imaging, usually MRIs to guide care. These images often show degenerative disc     disease and other common pathologies in older adults, even those who are pain free, which can     lead to misdiagnosis and treatment. The investigators believe that Chronic Low Back Pain is a     syndrome, a final common pathway for the expression of multiple contributors that often lie     outside the spine itself. For example, hip osteoarthritis, knee pain, and even anxiety could     all lessen back pain if addressed and treated probably.      Investigators will measure participants' low back pain-associated disability with the     well-validated RMDQ. Data will be collected at baseline and monthly via telephone. The     investigators hypothesize that veterans who receive PCCET will experience significantly     greater reduction in low back pain-associated disability than those who receive IAUC at six     months.      Investigators will also measure participants' low back pain with the 0-10 Numeric Rating     Scale for Pain. Data will be collected at baseline and monthly via telephone. The     investigators hypothesize that veterans who receive PCCET will experience significantly     greater reduction in low back pain than those who receive IAUC at six months.      The goal of this study is to compare patients treated with usual care, which usually starts     with imaging, versus patients who are treated by trained geriatricians who know how to     recognize and address 11 key conditions that commonly drive pain and disability in older     adults. The investigators believe that older patients who receive care tailored to their     needs by educated PCPs will ultimately have less back pain and, more importantly, better     quality of life.   "
44940|NCT02697422|"     The purpose of this study is to test if having a Veteran peer health coach will improve blood     pressure control among Veterans with high blood pressure and at least one other     Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health     messages, discuss goal setting, and action planning around health behavior changes shown to     decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity,     and smoking cessation. Facilitators, barriers, and costs of the intervention will be     determined.   "
44941|NCT02697409|"     A two armed randomized trial is evaluating the effect of the medical-student-delivered     school-based intervention Education Against Tobacco on the smoking behavior of adolescents in     7th grade of secondary school. The primary endpoint is the change in smoking prevalence     between the two groups.   "
44942|NCT02697396|"     This project aims to raise awareness and improve HPV vaccination rates among children of     Mexican American parents through the implementation of a tailored social marketing campaign     which includes text messaging reminders.   "
44943|NCT02697383|"     The purpose of this study is to see what effects, good and/or bad, the combination of     ixazomib and dexamethasone has on the patient and the smoldering multiple myeloma.   "
44944|NCT02697370|"     Patients with severe Haemophilia A need prophylactic factor VIII to reduce their risk of     joint and soft tissue bleeds and to prevent or reduce joint damage. It is common practice to     give enough factor VIII to maintain the trough level above 1% of normal and this has been     supported in retrospective studies.      The amount of factor VIII required to maintain this trough level varies markedly between     patients because their factor VIII half lives are different. This study will assess the role     of regular pharmacokinetic (PK)monitoring and dose adjusted factor VIII to establish whether     this is a more cost effective way of giving treatment and whether it is feasible in routine     clinical practice. Patients will be treated for 6 months with their standard factor VIII     regimen and followed up to establish their bleed frequency. They will then receive     pharmacokinetic adjusted factor VIII to maintain a trough above 1.5% for a year and their     bleed rate compared to standard treatment. If they have increased break through bleeds their     factor VIII will be increased to maintain a trough of 3%.   "
44945|NCT02697357|"     The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation     Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include     partners, family members, children, parents, and friends providing informal care to a     patient. Providing care to someone with cancer can be difficult. The purpose of this     intervention is to improve coping and physical well-being among caregivers, which in turn     will allow them to provide better care for their loved ones. Investigators would also like to     learn about biological factors like stress that may affect one's emotional and physical     well-being. This study will allow to better understand caregivers needs, and further develop     a program to provide services to caregivers within MSKCC community and nationwide.   "
44967|NCT02697071|"     This research study will be a prospective, randomized, double-blind, placebo-controlled     trial. Because ketamine has yet to be directly studied as treatment for acute migraine     headache in the emergency department, the research team is initially interested if ketamine     can reduce pain scores in headache patients and reduce the incidence of recurrence while     exhibiting an adequate safety profile. By using a placebo-controlled study design, the     research team can adequately investigate the effectiveness of the medication in a subgroup     previously not well studied.   "
44946|NCT02697344|"     This phase I/II trial studies the side effects and best dose of R-(-)-gossypol acetic acid     when given together with lenalidomide and dexamethasone and to see how well it works in     treating patients with multiple myeloma, also known as plasma cell myeloma, that has come     back after a period of improvement or has gotten worse after treatment. R-(-)-gossypol acetic     acid may stop the growth of cancer cells by recognizing certain proteins and stimulating     programmed cell death. Lenalidomide may stimulate or suppress the immune system in different     ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone,     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving R-(-)-gossypol acetic     acid with lenalidomide and dexamethasone may work better in treating patients with multiple     myeloma.   "
44947|NCT02697331|"     Aim of the work The aim of this study is to assess the efficacy of the use of vaginal     progesterone as a method of prevention of preterm labour in twin gestations with short cervix     .      Study Design:      The study is designed as randomized ,placebo-controlled, clinical trial . All women with     dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out     patient clinic. Randomization of cases will be done by computer method . 130 women with     dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm discovered on     transvaginal sonogram between 20w to 24w gestational age will be enrolled in the study and     will be distributed in two groups:group P (cases ) and group N (controls) . The randomization     allocation will be 1 : 1 (vaginal progesterone capsule : placebo).   "
44948|NCT02697318|"     The purpose of this project is to demonstrate that there is a new easier method to instill     eye drops in ones own eye that is as effective as applying a drop directly to their open eye.     The benefits of this new method include better medication compliance and reduced patient     anxiety from instilling their eye drops. This secondary benefit should remove the     approach-avoidance response that prompts some patients to delay or give-up on instilling     their drops just to avoid the angst and frustration produced by the challenge.      The new method involves the patient instilling the eye drop onto their closed eyelid and then     blinking the eye drop into their eye. We aim to show that this method has a similar     therapeutic effect as the routine administration of an eye drop to an open eye.   "
44949|NCT02697305|"     Branched chain amino acids (BCAA) are known to exert insulinogenic effect. Whether this     effect is mediated by incretins (GLP-1, GIP) is not known. The aim of the study was to show     incretin effect of BCAA, i.e. whether the oral administration of BCAA elicits higher insulin     and incretin response when compared with IV route of the same dose of BCAA. Eighteen healthy,     male subjects participated in three tests: IV application of BCAA solution (30.7±1.1 g of     BCAA, IV BCAA) second was oral ingestion of BCAA capsules in the same dose (ORAL BCAA) and     third experiment was oral placebo (PLACEBO). Glucose, insulin, GLP-1, GIP, valine, leucine     and isoleucine levels were measured at time interval for up to 4 h.   "
44950|NCT02697292|"     The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment     reduces significantly the number of epileptic seizures in cases of autoimmune epileptic     seizures.   "
44951|NCT02697279|"     In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous     abscesses. Traditional incision and drainage (I&D), with or without packing of cutaneous     abscesses has long been the accepted standard of care. This procedure is often very painful     for the patient. Additionally, compliance with wound care and follow-up can present barriers     to proper care and healing. Research has suggested that incision and loop drainage of an     abscess may be another effective treatment for simple cutaneous abscess. Thus far, research     into this procedure has been limited to the pediatric population with small sample sizes. In     these previous studies, this technique was found to be an effective and less painful     treatment for abscesses. Research has not been done in the adult population using this     procedure. If this procedure is found to be as effective and less painful in the adult     population, then it should be considered as a potential preferred I&D method for cutaneous     abscess in the ED.   "
44952|NCT02697266|"     The purpose of the current proposal will be to examine the clinical performance of both     physicians in training as well as experienced faculty in pre and post call situations. Groups     will be matched for gender, age, experience and employment duration during regular hours     versus immediate post call hour.   "
44953|NCT02697253|"     The goal of this project is to identify predictors of success in the treatment of obesity     after roux-en-y bariatric surgery. The specific aims of this proposal are to:        1. employ behavioral tests of mechanisms that control food intake in normal weight          individuals, to determine which intake control mechanisms lead to changes after          Roux-en-y gastric bypass (RYGBP); and        2. measure behavioral and psycho-social predictors of weight loss and food intake          reduction, so as to determine which are most predictive of successful weight loss and          food intake reduction.      The mechanism investigators propose to account for success is reduction in food intake     brought about by the pattern of hormone release, particularly glucagon-like peptide-1     (GLP-1), and gastric distention, both known to underlie satiation, coupled with     post-ingestive changes in reinforcing value of food and motivation to consume. Tests of the     hypothesis will be done by measuring responses to tasting, working for, and consuming, foods     on sensory, motivational, cognitive, and physiological variables, including amount consumed     and rate of eating under standardized conditions, before surgery and at a two year follow up     visit. In addition the inhibitor exendin-9-39 (EX9) will be infused before a meal to     determine whether blockade of GLP-1 Receptor after surgery partially reverses intake     reduction. Investigators predict that successful patients will show changes that favor     reduction in food intake, rate of eating, motivation to consume, reward value of foods, and a     hormone profile that has been shown to generate satiation and maintain reduction in intake     (e.g. increased Cholecystokinin (CCK), GLP-1, reduced ghrelin). To the extent that     psycho-social and cognitive factors may override physiological brakes to eating behavior, the     subjects may fail to achieve success, and consequently the failure may be predicted from     over-impulsiveness or inability to suppress working for rewarding food stimuli. To test these     hypotheses, a total of 50 patients will be enrolled prior to RYGBP and restudied 2 years     after the surgery. Based on known high attrition in this population and our past 10 year     experience with bariatric research, it is estimated that 100 patients will need to be     enrolled over 2 years to obtain 50 who complete testing at 2 years. EX9 studies will be done     in a subset of 30 completers, only after roux-en-y gastric bypass (RYGBP), 15 failure (<15%     weight loss) 15 success ( >30% weight loss).   "
44954|NCT02697240|"     Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from     sickling of red blood cells, that can lead to pain or organ complications such as acute chest     syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound     important for dilating the blood vessel wall. Citrulline is a substance that is known to     increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of     continuous IV citrulline that can be given to individuals with sickle cell disease     experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side     effects.   "
44956|NCT02697214|"     Over the last two decades, there has been a proliferation of commercially available heart     rate monitors. Recognizing that elite athletes often use heart rate to monitor training and     assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring     systems to the general public. Recently, there has been a move from monitors that rely on     chest straps to measure electrical activity toward more convenient, wrist-worn monitors that     employ optical sensing technology similar to that used for pulse oximetry. While the accuracy     of chest strap monitors has been assessed in a variety of studies, there is no data     concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors'     accuracy is important both for the subjects who rely upon these monitors to guide their     athletic activity and for the physicians to whom these individuals report their heart rate     readings.   "
44957|NCT02697201|"     Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells     for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes     occurs when the cells of the body become resistant to the effects of insulin, and this causes     high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the     heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed     at preventing and treating type 2 diabetes.      Mitochondria are cellular structures that are responsible for turning nutrients from food,     into the energy that our cells run on. As a result, mitochondria are known as the powerhouse     of the cell. Mitochondria are dynamic organelles that can move within a cell to the areas     where they are needed, and can fuse together to form large, string-like, tubular networks or     divide into small spherical structures. The name of this process is mitochondrial dynamics     and the process keeps the cells healthy. However, when more food is consumed compared to the     amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a     leak of partially metabolized nutrients that can interfere with the ability of insulin to     communicate within the cell. This may be a way for the cells to prevent further uptake of     nutrients until the current supply has been exhausted. However, long term overload of the     mitochondria may cause blood sugar levels to rise and lead to the development of type 2     diabetes.      This study will provide information about the relationship between mitochondrial dynamics,     insulin resistance and type 2 diabetes.   "
44958|NCT02697188|"     Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and     one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.   "
44959|NCT02697175|"     To assess the effect of live video-colposcopy on women´s anxiety.   "
44960|NCT02697162|"     Study design is a prospective, randomised, double-blind, and interventional. Primary aim of     the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary     catheters in prevention and reduction of catheter-associated urinary tract infections in     children with neurogenic bladder. Secondary aim is to assess feasibility of antiseptic-coated     intermittent hydrophilic urinary catheters in neurogenic bladder management. Octenidine     chloride will be used as antiseptic.   "
44961|NCT02697149|"     Radiation exposure may put endoscopists at risk when performing endoscopic retrograde     cholangiopancreatography. Although non-radiation endoscopic retrograde     cholangiopancreatography was reported in pregnant women in previous reports, it remains     unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe     when endoscopists were not expose to radiation. This study was to evaluate the effectiveness     and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in     patients with complexity level I/II.   "
44962|NCT02697136|"     The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs.     placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid     vessel wall area as measured by 3TMRI, when administered to patients with familial primary     hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.   "
44963|NCT02697123|"     The purpose of the study is to prospectively assess the prevalence of venous thrombosis in     women hospitalized for Cesarean Section, vaginal delivery or extended antepartum     hospitalization by using Compression ultrasound of the entire proximal venous system of the     lower limb veins.   "
44964|NCT02697110|"     Social interaction (in the form of serve and return exchanges) between child and parent are     crucial for psychosocial, physical and cognitive development. Parents in sub-Saharan     countries are ill-equipped to maximize the benefits from this interaction. The investigators     approach builds on the traditional outlook that it takes a village to raise a child i.e.,     not only the parents but other extended family members play a role as caregivers to young     children. The investigators intention is to use the existing post-natal/child welfare clinics     to deliver an intervention, which uses culturally acceptable videos and active skills     building, to deliver health messages and practical skills to women, with the intention that     they will subsequently engage and teach their partners and other caregivers about early brain     stimulation and child development.   "
44965|NCT02697097|"     Hip Muscle Strength in femoro-acetabular impingement participants versus normal controls.      To investigate the hip muscle strength in a normal control group and compare this to patients     who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and with     confirmed radiological features).   "
44966|NCT02697084|"     Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6%     of anorectal cancers. Incidence is less than 1/100 000 of the general population. However,     the incidence has increased considerably over the past three decades. The main risk factors     are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy     alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of     the most appropriate treatment strategy will condition the patient's prognosis. Consequently,     early assessment of the initial extension of the tumor, its therapeutic response and relapses     constitute determining factors in the management of the disease Despite the good results     obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage     amputation can then prove effective in cases of local or loco-regional relapse. The great     majority of relapses occur within 2 years after treatment. Reported prognostic survival     factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node     involvement.      The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses     principally on the clinical examination although the type and frequency of the paraclinical     examinations are not backed by any consensus.   "
44970|NCT02697032|"     Rationale: The purpose is to evaluate whether non-invasive in vivo imaging of androgen     receptor (AR) presence in metastatic breast cancer patients by means of     18F-fluoro-dihydrotestosterone positron emission tomography (FDHT-PET) can be used to predict     (early) treatment response to, and optimal dosing of, the anti androgen bicalutamide. The     ultimate goal is to contribute to optimal selection of breast cancer patients for anti     androgen treatment. Objective: Feasibility to detect a diffrence in uptake on 18F-FDHT scan     after 6 weeks of treatment with bicalutamide in metastatic breast cancer patients. Secondary     Objectives: to describe whether changes in 18F-FDHT tracer uptake after six weeks associates     with response to bicalutamide, to describe whether changes in AR availability are different     for breast cancer subgroups during treatment with bicalutamide and to describe whether     18F-FDHT tracer uptake is influenced by the amount of AR tumor expression. Study design: This     is a single arm, one stage feasibility study, which will be executed in the University     Medical Center Groningen, The Netherlands. The primary endpoint of the study is to evaluate     the difference in 18F-FDHT uptake in tumor lesions after 6 weeks of bicalutamide treatment in     patients with AR-positive metastatic breast cancer. Patients will be treated with     bicalutamide until progression or unacceptable toxicity is encountered. Study population: The     investigators will include 20 postmenopausal metastatic breast cancer patients with an AR     positive, HER2 negative tumor. Patients should be restaged clinically with bone scintigraphy     and CT scan within a 6 week timeframe of the PET examinations. Intervention: All patients     will receive a baseline FDHT-PET scan and start with bicalutamide treatment 150mg daily.     During follow-up patients will receive one FDHT-PET scan after 6 weeks. Treatment with     bicalutamide will continue until progression or unacceptable toxicity is encountered. Main     study endpoint: The percent difference in 18F-FDHT uptake in tumor lesions after 6 weeks of     monotherapy bicalutamide. A minimum decrease of 20% in 18F-FDHT uptake after 6 weeks compared     to baseline uptake with an α of 0.05 and a power of 80%, is considered clinical significant.   "
44971|NCT02697019|"     The primary aim is to investigate the effectiveness of an Internet-delivered Emotion     Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).   "
44972|NCT02697006|"     The purpose of this study is to collect prospective safety and performance information for     the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung     failure or in high risk percutaneous intervention procedures in catheterization lab.   "
44973|NCT02696993|"     There are 2 parts to this research study: Part 1 (dose escalation) and Part 2 (dose     expansion).      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     nivolumab that can be given either with radiation therapy alone or in combination with     radiation and ipilimumab, in patients with NSCLC. The goal of Part 2 of this study is to     learn if the dose of nivolumab found in Part 1 when given with radiation therapy and     ipilimumab can help to control the disease.   "
44974|NCT02696980|"     The purpose of this study is to test the effect of increasing lung volume with a simple     hand-held device to both prevent, and also to relieve, airway constriction in people with     asthma and a BMI ≥ 35 kg/m2.      Twenty people with late onset non-allergic asthma and a BMI of ≥ 35 kg/m2 will be recruited.     The efficacy of elevating lung volume on both preventing and reversing bronchoconstriction     will be tested. Lung volume will be modulated by breathing out against a small level of     resistance (positive expiratory pressure).   "
44976|NCT02696954|"     Primary Objective        -  To characterize the potential pharmacokinetic interactions of artemether -lumefantrine,          amodiaquine and primaquine in healthy adult subjects.      Secondary Objectives        -  To characterize the pharmacokinetic properties of artemether-lumefantrine, amodiaquine          and primaquine when given alone and in combination.        -  To evaluate the safety and tolerability of co-administered artemether-lumefantrine,          amodiaquine and primaquine.        -  To investigate pharmacogenetic polymorphisms affecting drug levels of          artemether-lumefantrine, amodiaquine and primaquine and their metabolites.   "
44977|NCT02696941|"     SGLT2 inhibitors have been proven to be effective in several preclinical rodent models of     non-alcoholic fatty liver disease (NAFLD). Using a choline deficient diet to recapitulate     some of the histological features of human non-alcoholic steatohepatitis (NASH), it was found     that 5 weeks of SGLT2 inhibition led to significant reductions in hepatic triglyceride     content and improved markers of liver fibrosis. Similarly, 4 weeks of treatment in obese mice     led to improved glucose tolerance, reduced hepatic steatosis and reduced markers of liver     oxidative stress in a dose dependent manner. These findings corresponded with an improvement     in traditional liver function tests including the aminotransferases (ALT and AST). The widely     used antidiabetic agent metformin has been shown in rodent models to increase hepatic insulin     sensitivity and lower liver fat content which is in contrast to the findings in humans where     metformin increases hepatic insulin sensitivity, reduces body weight but does not decrease     liver fat content. The reason for the discrepancy between the animal and human studies, with     regards to liver fat content remains unclear.      The investigators hypothesise the following:        -  SGLT2 Inhibitors have the potential to decrease lipid accumulation in the liver through          reduced de novo lipogenesis (DNL)        -  There will be no decrease in endogenous lipid synthesis (DNL) with metformin and thus no          change in liver fat content.      There are two arms to this study.        -  Arm 1: x10 participants with poorly controlled type 2 Diabetes (T2DM) who have been          recommended to start an SGLT2 inhibitor called dapagliflozin will be recruited.        -  Arm 2: x13 participants with insulin resistance who have not yet started any diabetic          medication will be recruited and will be prescribed metformin at standard clinical          doses.      The two arms will run in parallel and all participants will undergo identical investigations     before and after 3 months of treatment with either dapagliflozin or metformin. Investigations     will include liver magnetic resonance imaging/spectroscopy, fat biopsy, fat microdialysis     sampling, two-step hyperinsulinaemic euglycaemic clamp, breath sampling and stable glucose     and palmitate isotope infusions.      The investigators aim to show that SGLT2 inhibition decreases liver fat whereas we aim to     demonstrate why liver fat remains unchanged in humans, treated with metformin. These data     will provide the first evidence for the use SGLT2 inhibitors in NAFLD, and will be highly     informative for the design of future clinical studies. Moreover, the data gained from the     metformin arm of the study will provide the first mechanistic evidence in humans of the     effects of metformin on hepatic fatty acid metabolism.   "
44978|NCT02696928|"     Feasibility of methylene blue-based combination therapy in the radical treatment of adult     patients with Plasmodium vivax malaria in Ethiopia: a randomised controlled pilot trial      Study rationale:      Elimination has become the goal of malaria programmes in an increasing number of endemic     countries and regions. Primaquine (PQ) is the only registered drug for radical cure of     Plasmodium vivax malaria. Prolonged PQ-based combination therapy carries safety concerns and     resistance to chloroquine (CQ) and PQ is emerging. Methylene blue (MB) has recently been     shown to be safe and effective in the treatment of Plasmodium falciparum malaria in West     Africa. As there is evidence for MB probably being effective against the hypnozoites of     Plasmodium vivax, MB-based drug regimens could be an alternative to PQ-based combination     therapy in Plasmodium vivax malaria.      Study objectives:      The main objective of this trial is to study the feasibility of MB-based combination therapy     in patients with uncomplicated P. vivax malaria in an endemic area of Ethiopia.   "
44979|NCT02696915|"     Fracture femur is a common injury which is associated with excruciating pain. Positioning for     neuraxial blocks is always challenging because even slight overriding of the fracture ends is     intensely painful .It can causing major patient distress which accompanied by well-known     physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and     increased cardiac work that may compromise high-risk cardiac patients.      Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of     the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but     it is also associated with minimal risk as the local anesthetic is injected at a safe     distance from the femoral artery and femoral nerve. It is always safe to perform the fascia     iliaca compartment block prior to spinal anesthesia as the patient can respond during     administration of the local anesthetic and can prevent intra-neuronal injections   "
44982|NCT02696876|"     This is a proof-of-concept study to determine the safety and efficacy of a novel device to     increase the reparative capacity of the knee. The discovery of a resident population of     mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this     reparative cell population having direct access to superficial cartilage and joint     structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel     strategy for joint repair. Current arthroscopic procedures result in the removal of all SF     MSCs due to continuous irrigation throughout the procedure. The current study would benefit     the patient by greatly increasing the reparative capacity of the joint by bolstering MSC     numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the     synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot     formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the     marrow and may result in faster, better quality repair.   "
44983|NCT02696863|"     The main objective is to identify obstacles and elements facilitating the implementation of a     tracking device Broncho Pulmonary Cancer during the course of care.      The secondary objective is to assess patient knowledge and information received on their     previous occupational exposure during their professional activity.      This is a prospective multicenter study of qualitative methodology through in-depth     interviews conducted with patients treated at ICLN and CHU Saint-Etienne   "
44984|NCT02696850|"     The goal of this research project is to explore the impact of the addition of budesonide to     high-volume, low-pressure nasal sinus saline irrigation (aka Neti-Pot-type systems) for     patients with chronic rhinosinusitis with or without nasal polyps.   "
45018|NCT02696408|"     The LLLT has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated     lesions. There are little data in the literature showing its efficacy in prevention of     mucositis in cohorts of patients with hematopoietic stem cells transplantation.      The main objective of this study is to assess the efficacy of a prophylactic low level laser     therapy performed by nurses on the severity of oral mucositis during HSCT.   "
44985|NCT02696837|"     In prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair     using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four     groups. Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation     without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4:     Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant. Apart from standard     monitorization, all patients' intragastric pressures will also be monitored. Patients' age at     presentation, gender, time of surgery, time of anesthesia, intragastric pressure,     intraabdominal pressure, intraoperative findings and complications will be noted and compared     between groups.   "
44986|NCT02696824|"     The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South     Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for     depression and adherence, integrated into the HIV care setting in patients with HIV who did     not achieve viral suppression from first-line treatment. The CBT treatment will be compared     to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described     in study endpoints section below).   "
44987|NCT02696811|"     Studies have shown that certain compounds inside vegetables can reduce the risk of cancer.     Carrots in particular have an association with reduced incidence of colorectal, bladder and     breast cancer. Compounds in carrots, called polyacetylenes, have been studied in isolated     cells that have shown a reduction in cancer cells as well as inflammatory markers which have     been associated with an increased risk of cancer. These polyacetylenes have not been well     studied in the human body and it is unclear whether they are able to affect the biomarkers of     health (disease) including DNA damage and inflammatory markers. The aim of this research     project is to determine whether eating a portion of white carrots every day for 6 weeks can     lead to a reduction in DNA damage and inflammatory markers compared to a control period of 6     weeks consuming a polyacetylene-free diet and a control food of a high fibre oat biscuit.   "
44988|NCT02696798|"     The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor     necrosis factor (TNF) inhibitor-experienced participants with radiographic axial     spondyloarthritis (rad-axSpA).   "
44989|NCT02696785|"     The main purpose of this study is to evaluate the safety and efficacy of the study drug known     as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive     participants with radiographic axial spondyloarthritis (rad-axSpA).   "
44990|NCT02696772|"     Long term maintenance of weight loss is generally poor, which is at least partly due to     increased feelings of hunger associated with restricting what can be eaten. Intermittent     severe energy restriction is a novel dietary strategy that requires individuals to consume a     very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on     the other days in the week. However, the effect of a consuming a very-low energy diet on     appetite regulation, which might represent a key marker of long-term adherence to dieting,     has not been determined. This study aimed to assess the effects of severely restricting     energy intake for 24 h on markers of appetite regulation, energy balance and metabolism     compared to an adequate energy trial.   "
44991|NCT02696759|"     The purpose of this research is to test whether bacteria that normally live in the intestines     play a role in fighting cancer. It is believed that the development and behavior of these     immune cells may be influenced by bacteria and other microorganisms living in the gut. In     turn, the activities of these immune cells could work with anti-cancer therapies to make them     more, or less, effective.   "
45012|NCT02696486|"     The purpose of this is to develop and implement a pilot study that will demonstrate the     ability to recruit, enroll, retain, conduct exercise training, and collect pre and post     outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in     patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).   "
45013|NCT02696473|"     Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and     anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the     polyacetylenes could have an effect in vivo, this study aims to determine whether they are     detectible in human biofluids after the consumption of a portion of carrots and whether a     difference is seen between a large and small portion.   "
44992|NCT02696746|"     To understand the pathophysiological basis of heritable pain syndromes. This will consist of     a number of components:        -  Determine the genetic basis for heritable pain syndromes.        -  Investigate the pain symptoms, psychological co-morbidity and quality of life in          patients with heritable pain syndromes.        -  Use quantitative sensory testing to investigate abnormalities in sensory processing.        -  Use imaging modalities to investigate the neural correlates of pain perception in          heritable channelopathies.        -  In select patients to perform skin biopsy to determine if there has been any damage to          C-fibres.        -  To perform skin biopsy in order to culture fibroblasts and neural crest stem cells for          future studies into the molecular basis of altered pain perception.        -  To use neurophysiological tests, the axon reflex, and conditioning challenges to          determine how peripheral nerves, in heritable channelopathies and unusual pain          syndromes, have been altered.        -  Microneurographic recordings for directly detecting the function of pain fibres in          peripheral nerves. Knowledge gained from the study will be used to aid the further          development of genetic testing and specific pain questionnaires for the diagnosis of          heritable pain syndromes secondary to channelopathies.        -  Ultimately better knowledge of underlying pathophysiology in these heritable pain          conditions may inform the development of novel treatments.   "
44993|NCT02696733|"     Obturator nerve block is an effective method to prevent adductor muscles contraction during     transurethral resection of bladder tumour localized on the lateral wall. Due to prior spinal     anaesthesia the patient does not feel uncomfortable during the blockade and the interadductor     approach gives the possibility to perform it in the lithotomy position. The aim of the study     was to evaluate the safety and effectiveness of ultrasound-guided obturator nerve     identification and blockade for TURBT.   "
45019|NCT02696395|"     Hip replacements are being performed on an increasingly active population, who are likely to     wear their implants out prematurely. New hip replacements have been devised to minimise the     risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the     performance of two established types of hip replacements using Corail and Tri-Lock stems     along with Deltamotion acetabular component. The primary objective of the trial is to compare     the long term stability of these two devices.To do this, the study will use an advanced 3D     Xray technique to detect migration of the components at 3 years. The study will also measure     micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures     and change in bone density.This study is being conducted at a single site, at the Nuffield     Orthopaedic Centre, Oxford.   "
45069|NCT02695745|"     The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in     primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and     mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by     UVB (ultraviolet B) irradiation and topical capsaicin.   "
44994|NCT02696720|"     Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation; in     particular most persons who undergo limb amputation will experience phantom pain. The     neuropathic nature of PLP suggests the involvement of both peripheral and central     neurological mechanisms, including neuroplastic changes in the central nervous system. PLP as     other central nervous system-related pain syndromes remains a challenge for treatment. Scar     hyperalgesia involves peripheral mechanisms and results frim the production of substances     liberated by damaged skin cells. These inflammatory substances lower the pain threshold by     altering the chemical environment of skin nerve endings. Scan hyperalgesia is associated with     secondary mechanical hyperalgesia in the skin area around the scar.      The lidocaine patch 5% is a topical analgesic acting by blocking sodium channels of     peripheral nerve endings and by inhibiting ectopic discharges in sensitized and hyperactive     cutaneous nociceptors. The patch is noninvasive, with minimal systemic absorption resulting     in a reduced risk of drug-drug interaction. In addition, a central analgesic effect of     lidocaine has been suggested. The lidocaine patch 5% is currently licensed for the treatment     of symptomatic postherpetic neuralgia. It also has been successfully used in patients with     other neuropathic pain states, such as entrapment neuropathies, painful idiopathic distal     sensory polyneuropathies and postoperative/post traumatic neuropathic chronic cutaneous pain.     The lidocaine patch has not been studied for the management and prevention of phantom limb     pain.      The aim of the present research is to investigate if a lidocaine patch 5% is effective for     reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent     peripheral nociceptive input from the stump after surgery may drive maladaptive cortical     reorganization leading to chronic central pain and thus promote chronic phantom limb pain.     Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of     peripheral nociceptive afferents and thus decrease the likelihood of developing persistent     phantom limb pain.      This study is designed as a randomized controlled multicentric double blind trial, in which     the effectiveness of applying a 5% lidocaine patch for 6 weeks will be compared with a sham.   "
44995|NCT02696707|"     Several large adjuvant trastuzumab trials have demonstrated improved overall survival, in     participants with early stage breast cancer, with a 33% decrease in risk of death. However,     retrospective analyses of participant outcomes in these trials have demonstrated increased     risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%).      At this time, investigators are unable to predict which participants are at increased risk of     cardiac-related treatment complications. Currently all patients receive regular cardiac     imaging throughout their one year of trastuzumab treatment.      At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains     unknown, and several published consensus guidelines are currently in use as standard of     care.   "
44996|NCT02696694|"     This study aims to investigate the impact of serum progesterone concentrations on the day of     embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary     outcomes, the investigators will investigate if endometrial volume measured by     three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone     levels and with chances of pregnancy.   "
44997|NCT02696681|"     Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for     individuals with HIV with various psychological comorbidities, which the investigators call     syndemics. Syndemics are co-occurring psychosocial problems that interact with each other     and with health behavior such as HIV sexual transmission risk behavior and adherence to self     care.   "
44998|NCT02696668|"     This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance     exercise programme on falls risk, balance confidence and quality of life in older adults who     fall or at risk of falling when implemented in a group setting.   "
44999|NCT02696655|"     (i) To develop a behavioural intervention that supports healthcare professionals to     effectively deliver lifestyle behaviour change of patients undergoing liver transplantation      (ii) To assess the acceptability and feasibility of the behavioural intervention during     routine practice   "
45000|NCT02696642|"     To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab     ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or     renal impairment   "
45001|NCT02696629|"     The prevalence of OSA is 3.5~4.6% in Chinese adults. OSA leads to repetitive hypoxemia,     hypercapnia, and arousal from sleep and is an independent risk factor for hypertension,     stroke, coronary artery disease and congestive heart failure. CPAP is the first-line     treatment for OSA. But many patients do not adhere to therapy.      The upper airway(UA) anatomical abnormality is a prominent risk factor in Asian OSA patients,     which might be improved by surgical strategies. However, surgery shows variable clinical     effectiveness. One important reason for patients responding poorly to single treatment     procedure is that multiple abnormal physiological traits contribute to OSA.      High loop gain is one of the key non-anatomical risk factors. It will be useful to     individualize therapy in OSA by better understanding the reversibility of increased LG, the     interaction of LG and UA anatomical change as well as the condition that trigger reduction of     LG.      The project will test the hypothesis of 1) Elevated LG is induced in some patients and is     reversible by treatment of OSA; 2) Change of LG is related to the improvement of sleep apnea;     3) An elevated LG is related to residual sleep apnea after upper airway surgery, which might     be eliminated by adjunct CPAP therapy after surgery. The results would improve the efficiency     of non-CPAP treatment and provide a potential combined treatment option for those patients     with both elevated loop gain and anatomy risk factors in the Asian population.   "
45002|NCT02696616|"     Investigation of safety and tolerability of BI 655088 following intravenous infusion of     single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088     after single dosing   "
45003|NCT02696603|"     The purpose of this study is to understand variation in the symptoms of Parkinson disease.     This study uses an iPhone app to record these symptoms through questionnaires and sensors.   "
45004|NCT02696590|"     This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in     multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each     method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level,     the durability of the response, the practicality and the possible toxicity.   "
45020|NCT02696382|"     The investigators plan to test an innovative, home-based, short duration, high intensity     exercise program designed for application in the immediate post-hospitalization period in     older Veterans. Preliminary data suggest a more intensive approach to physical therapy in     older adults after hospitalization is safe and maximizes mobility more than usual care. The     Veterans participating in the high intensity exercise program will receive therapy utilizing     higher resistance exercises. Outcomes from this group will be compared to data collected from     the patients receiving standard, lower resistance therapies.   "
45021|NCT02696369|"     This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with     different epinephrine concentration in patients undergoing surgical extraction of impacted     lower third molars   "
45005|NCT02696577|"     Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine     growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine     growth restriction is diagnosed antenatal; however, some of these fetuses, especially if     unscreened during pregnancy, may be detected only in the neonatal period. It is very     important for obstetricians and perinatologists to identify growth restricted fetuses,     because this fetal condition is associated with significant perinatal morbidity and     mortality.      Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon     atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid     end, which is considered the beginning of the chain, thus alpha, and the methyl end, which     is considered the tail of the chain, thus omega. Omega3 improve fetal wellbeing by two     mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and     lactation normalizes intrauterine growth restriction induced changes in adipose deposition     and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation     increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin     receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation     normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic     function in intrauterine growth restriction   "
45006|NCT02696564|"     A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day losartan     on the progression of emphysema as measured by quantitative HRCT compared to placebo   "
45007|NCT02696551|"     This is a retrospective and prospective designed study, included hospitals are 1:1 assigned     into two groups: ①Interventional hospital, which will receive 3-month medical education;     ②Non-interventional hospital, which will not receive 3-month medical education. During 1     month before education, all the electronic records of outpatients and inpatients who visit     the included rheumatologists will be collected and the data of test and evaluation results of     spondyloarthritis (SpA) patients diagnosed according to new Assessment of Spondylo-Arthritis     International Society (ASAS) criteria will be collected from outpatient electronic records     and inpatients medical charts; in the 3 months after education, the same data will be     collected and compared with the data before education, and the impact of medical education on     physician behaviour will be analyzed. Meanwhile, the understanding and acceptance level will     be evaluated by the questionnaire, the differences before and after education and the impact     of education on physician cognition will be evaluated.   "
45008|NCT02696538|"     The purpose of this research study is to investigate how useful three balance tests are in     predicting fall risk in the individual with traumatic brain injury (TBI). These tests are the     Functional Gait Assessment (FGA), the Berg Balance Scale (BBS), and the mini-Balance     Evaluation Systems Test (mini-BESTest).   "
45009|NCT02696525|"     Conduct a prospective study to confirm blood and urine ctDNA detection value in     non-small-cell lung cancer patients.   "
45010|NCT02696512|"     This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention protocol     in patients with severe disorders of consciousness (SDOC).   "
45011|NCT02696499|"     This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2,     proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring     hemodialysis.      The purpose of the study is to determine the efficacy and safety profile of PA101B delivered     via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic     despite using standard treatments.   "
45014|NCT02696460|"     Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A     common analgesia method is the topical administration of local anesthetics directly onto the     wound. However, complete wound debridement is often hampered by insufficient analgesia     leading to interruption of the actual debridement and fragmentation of treatment into more     frequent serial debridement sessions. Alternatively, the inhalation of an nitrous     oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the     investigators have compared the analgesic method of an eutectic mixture of topically     administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50%     N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.   "
45015|NCT02696447|"     The aim of the present study is to determine the frequency and to identify main risk factors     for venous thromboembolism of venous thromboembolic complications in a population of cancer     patients treated with a curative intent by ionizing radiation.   "
45016|NCT02696434|"     This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in     conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from     buprenorphine maintenance prior to the first dose of VIVITROL.   "
45017|NCT02696421|"     Ramadan fasting entails abstinence from eating and drinking between dawn and sunset. During     this month major changes in meal times and patterns, sleeping times and activity occur.     Starvation is known to lead to a compensatory reduction in energy expenditure. However, the     Ramadan fast is not synonymous with starvation as it involves intermittent periods of fasting     followed by gorging. People who fast during Ramadan feel less energetic. However, little is     known about the effects of this religious practice on energy metabolism. .      The aim of this study is to assess energy dynamics before and/or after and during Ramadan     fasting in non-obese participants. Resting metabolic rate (RMR), thermic effect of food     (TEF), active energy expenditure (AEE) and total energy expenditure (TEE) in free-living     conditions will be measured . Indirect calorimetry will be used to assess RMR and TEF, doubly     labeled water will be used to measure TEE and activity monitors will measure physical     activity. In addition, body composition analysis will be performed by bio-electrical     impedance. Blood sample will be taken to exclude medical factors affecting energy metabolism.   "
45022|NCT02696356|"     This is a study of an investigational cancer vaccine called GRN-1201. Treatment with the     GRN-1201 vaccine is a type of immunotherapy. The goal of immunotherapy is to stimulate the     body's immune system (white blood cells) to attack cancer cells and kill them. GRN-1201     consists of 4 different peptides (small parts of proteins) that are expressed by melanoma     cells. The intent of treatment with GRN-1201 is to increase your body's immune response to     melanoma.      To further increase your body's immune response against tumor cells, the GRN-1201 vaccine     will be mixed with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, also known as     sargramostim). GM-CSF is a man-made protein that helps stimulate the immune system and     increase the response against the tumor cells. This is a phase I study which means that this     will be the first time GRN-1201 is given in combination with GM-CSF to humans. It will be     tested in a small number of people to evaluate its safety, find a safe dose, and identify     side effects. The safety of GRN-1201 will be tested at three different doses; the GM-CSF dose     will remain the same.   "
45023|NCT02696343|"     Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via     orosensory entrainment (NTrainer) device technology and serial salivary gene expression     analyses, will be merged to examine the relation between gene expression, oral somatosensory     stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age     (CA) on 180 extremely preterm infants [EPIs] (24 0/7-26 6/7 GA and 27 0/7 - 28 6/7 GA)     enrolled at three neonatal intensive care units: Catholic Health Initiative (CHI) Health St.     Elizabeth (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical     Center (San Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer     treatment groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs     non-BPD). We hypothesize that the combination of the NTrainer® intervention for improved oral     feeding skills, along with objective salivary gene expression data to monitor response to     treatment and feeding development, will result in a novel, objective, and personalized     approach to neonatal oral feeding and reduce the duration of time to attain oral feeds while     improving feeding, growth and neurodevelopmental outcomes at 18 months' CA.   "
45024|NCT02696330|"     Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI   "
45025|NCT02696317|"     The purpose of this study is to evaluate the performance of two commercially-available     silicone hydrogel contact lenses in normal and low humidity environments after at least 7     days of wear.   "
45026|NCT02696304|"     Along with the improvement of childhood acute leukemia treatment, survival rates have     increased. Therefore, the number of long term childhood leukemia survivors has increased     progressively over the last decades. So, the assessment of long term health status in this     population becomes very important. Many studies have shown an increased risk of life     threatening late complications and early mortality. Cardiovascular morbidity and mortality     are particularly frequent. Among these late complications, the metabolic syndrome (MS) is an     important concern since it is associated with cardiovascular morbidity and mortality. The     overall MS prevalence in the French prospective cohort of survivors of childhood acute     leukemia was 9.2% and 18.6% in cases of total body irradiation (TBI) during the leukemia     treatment. Since the median age at MS evaluation was 21 years, this prevalence was very high.     Anyway, the MS pathophysiology in this population is still poorly understood. One of the most     recent hypothesis about the MS mechanism is based on the adipose tissue inability to store     fatty acids: when adipose tissue cannot expanse further to store excess nutriments then     lipids accumulate in other tissues. This ectopic lipids accumulation can cause insulin     resistance and MS.      The investigators hypothesized that the adipose tissue could be damaged by treatments     received during childhood acute leukemia treatment (particularly TBI). This leads to     morphological and functional abnormalities that could promote the insulin resistance and MS.      This ectopic adipose tissue contains less preadipocytes, which could impair its functional     properties.      The primary endpoint of this study is to compare the morphological and functional     characteristics of adipose tissue in patients with a MS who received or not TBI during     childhood leukemia treatment . This comparison will focus on:        -  The adipose tissue repartition and evaluation of the ectopic adipose tissue        -  Fibrosis and inflammation of the adipose tissue        -  Preadipocytes quantification      The secondary endpoint is to describe:        -  for the whole cohort of included patients,        -  the clinical and biological characteristics associated with the MS.        -  Cardiovascular risk factors and nutritional statement        -  Anthropometric measurements        -  Detection of other endocrinal abnormalities possibly associated with the MS        -  Analysis of inflammation blood markers and adipokines quantification.   "
45027|NCT02696291|"     The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral     solution when administered to healthy subjects three times a day (TID) for 7 days.   "
45028|NCT02696278|"     The goal of this study is to examine the effect of increasing children's intake of fiber and     unsaturated fat, through daily servings of hummus and vegetables, on their microbiome     profile.   "
45029|NCT02696265|"     Objective: The purpose of this study is to compare the efficacy and safety of ablation of     Atrial Fibrillation (AF) drivers marked by spatiotemporal dispersions and Complex     Fractionated Atrial Electrocardiograms (CFAEs) to Pulmonary Vein Isolation (PVI) based     ablation in patients with persistent AF.      Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival     compared to a PVI guided ablation.      Patient population: Patients with persistent AF will be randomized based on a 2:1 ratio into     one of two study arms:        -  CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF          aimed at restoring sinus rhythm during ablation.        -  PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter          control of pulmonary vein signals   "
45030|NCT02696252|"     Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an     Automated Applicator vs. a Manual Sensor Applicator   "
45031|NCT02696239|"     The purpose of this study is to evaluate the impact of implementing different types of     suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic     hysterectomy on cost, operative time and post operative surgical outcomes.   "
45032|NCT02696226|"     This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve     Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the     incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on     the incidence of reduced leaflet motion.   "
45033|NCT02696213|"     Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills, is a novel,     community-based, client-centred intervention where skills training is incorporated into     social activities that users want to perform. The trainer also offers problem solving     strategies to help manage environmental barriers and to promote social participation. This     intervention is different from customary scooter training in that customary training is often     very limited and focuses on learning discrete skills outside of the user's normal     environment. The purpose of this study is to explore the feasibility of conducting a     mixed-methods, rater-blinded, randomized controlled trial (RCT) for new scooter users, which     will evaluate the efficacy of SCOOT. We anticipate that the feasibility outcomes will be     strong enough to support the conduct of a subsequent multi-site trial with a sufficient     sample size to enable us to quantify definitive outcomes such as adverse events (e.g.,     injuries and abandonment).   "
45034|NCT02696200|"     Significant morbidity, mortality, and related costs are caused by traumatic brain injury     (TBI). An externally-worn medical device that applies mild jugular compression according to     the principle of the Queckenstedt Maneuver (the Device). Preliminary research suggests that     the Device has the potential to reduce the likelihood of TBI. The currently developed collar     has been approved for studies in humans and the results indicate safety for use during high     demand and maximal exertion activities, This study will investigate the effectiveness of this     device in high school athletes playing a collision sport such as football. The use of helmets     during such a high-risk sport will allow for collision measurement devices to be embedded in     the helmet and will not affect play or fit of equipment. Athletes participating in this study     will be randomly assigned to one of two groups: 1) Device wearing during the season or 2)     Non-device wearing during the season. The helmets of all participants will be outfitted with     an accelerometer which will measure the magnitude of every impact to the head sustained by     the athlete. Effectiveness of the device will be determined via differences in longitudinal     brain imaging and functional testing following competitive football participation. A subset     of athletes who report a diagnosed concussion will also receive additional brain     neuroanatomical and neurophysiological testing within a week following the diagnosed     concussive event. The purpose of the study is to monitor longitudinal changes in brain     structure and function between the preseason and postseason, in a population of football     playing athletes wearing the Device and compared to a similar population not wearing the     device. Secondly, the purpose is to determine the protection of the device relative to amount     and magnitude of sustained head impacts.   "
45035|NCT02696187|"     This study evaluates the effects of KOL-webben (the COPD web), an interactive web-based     system directed towards two target groups; people with chronic obstructive pulmonary disease     (COPD) and health professionals in primary care. KOL-webben include tools that improve health     literacy with a specific focus on 1) increased physical activity and 2) use of appropriate     self-management strategies. Moreover, KOL-webben include knowledge and tools directed towards     staff in the primary care aimed to implement provision of evidence based health promotion     interventions.The feasibility and effects of KOL-webben will be evaluated.   "
45036|NCT02696174|"     This is the Phase 3 of a 3 phase study to determine the feasibility, acceptability and     effectiveness of a health microinsurance scheme in improving health equity and clinical     outcomes for private primary care (PPC) in Kuala Lumpur, Malaysia. This two-arm, pre-post,     quasi-experimental trial consisted of utilizing a HMI scheme (experimental clinic) and normal     OOP payments (control clinic) for 6 months. The HMI scheme enabled subscribed households to     access a defined benefit package at a selected PPC for treatment and follow-up.   "
45037|NCT02696161|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with     involving compression of the median nerve in the carpal tunnel. Rather than other progressive     disease, CTS is characterized by remission and recurrence. Although many conservative     managements of CTS, the effectiveness of these methods is insignificant or only persist for a     short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients     with kinds of musculoskeletal disorders and recent reports showed being beneficial for     peripheral neuropathy in animal studies. Since 2014, two small clinical trials showed the     positive effect of PRP in peripheral neuropathy. One study shown the PRP has therapeutic     effect for peripheral neuropathy in patients with leprosy. In addition, PRP having protective     effect against neurological deficit of facial nerve during superficial parotidectomy.     However, these studies have not entirely proved the effects of PRP on peripheral neuropathy     because these studies enrolled small number of patients and lacked controlled design. In     addition, the PRP was not used for treating CTS so far. The investigators design a     randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP     injection in patients with CTS.   "
46224|NCT02680561|"     The purpose of the study is to characterize the pharmacokinetic profiles of fluticasone     propionate and/or salmeterol when delivered as a single oral inhalation dose of Fp MDPI and     FS MDPI.   "
45038|NCT02696148|"     This trial is conducted in the United States of America. The aim of this trial is to     investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the     body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide     in obese children aged 7 to 11 years   "
45039|NCT02696135|"     Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with     a prevalence of ∼0.2%. The disease affects all age groups, with marked clinical     heterogeneity, ranging from a normal life span without symptoms to poor outcomes such as     sudden cardiac death (SCD), advanced heart failure, or stroke.   "
45040|NCT02696122|"     Different anesthetic techniques have been proposed for carrying out Inguinal hernia repair,     including local anesthesia, regional and general. Even though local anesthesia is a more cost     effective anesthetic technique for such procedure, spinal anesthesia remain a popular     anesthetic technique. Traditionally, anesthesia and surgery studies have assessed outcomes     such as time to wake or hospital stay and the incidence of nausea, vomiting, pain or other     adverse events. Recently, a measurement that probes quality of life from the perspective of     the patient has been considered as a more important factor in clinical studies that wish to     investigate the effect of anesthesia and surgery on patient recovery and satisfaction. There     are no recent data on the application of a validated questionnaire to assess which anesthetic     technique, local infiltration under general anesthesia via laryngeal mask or spinal     anesthesia, would provide better quality of recovery in the opinion of the patients     undergoing inguinal hernia repair. The aim of the study is to perform a randomized clinical     trial comparing the quality of recovery (Quality of Recovery - 40) after local infiltration     under general anesthesia via laryngeal mask or spinal anesthesia for unilateral inguinal     hernia repair. METHODS - Seventy patients aged 18 to 65 years old, with an ASA physical     status I or II, who were scheduled to undergo local infiltration under general anesthesia via     laryngeal mask or spinal anesthesia for unilateral inguinal hernia repair at Santa Lucinda     Hospital will be enrolled in the study. The anesthesia was performed according to the     following sequence: L Group - intravenous (I.V.) propofol and alfentanyl, followed by     laryngeal mask airway (LMA) positioning. The anesthesia will be maintained by propofol. For     local anesthesia, approximately 50 ml of 0.5% ropivacaine will infiltrated along the line of     incision in the subcutaneous plane, followed by peripheral nerve block technique (e.g.,     ilioinguinal-hypogastric nerve block) and local wound infiltration at the fascial level. S     Group - spinal puncture followed by intrathecal 15 mg of 0.5% hyperbaric bupivacaine     injection and sedation with propofol by continuous infusion necessary to reach level 5 on     Ramsay Sedation Scale. After the end of surgery, all patients will be transferred to the     post-anesthesia care unit (PACU). Pain will be assessed every 15 minutes using a 0-10 numeric     pain rating scale and I.V. morphine will be administered to maintain the pain score below 4.     The QoR-40 will be administered by a blind investigator 24 hours after surgery.   "
45041|NCT02696109|"     The purpose of this study is exploring a theoretically guided intervention, Cornerstone,     which provides system 'boundary-spanning' services, including therapeutic services and     mentorship, to transition-age youth with mental disorders. Cornerstone is designed to improve     mental health service engagement and outcomes. The study uses a mixed methods approach to     refine Cornerstone, and a hybrid design examining feasibility, acceptability, and preliminary     impact with a randomized trial, alongside implementation.   "
45042|NCT02696096|"     This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain     activity and behavior associated with decision-making about rewards (DD task), working memory     and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate     dependent participants initiating buprenorphine. While stably using opiates (initial study     appointment) and again during withdrawal (approximately 3 days later), participants will     receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will     receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve     weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to     the first scanning session, weekly for two weeks and biweekly thereafter.      Participation for all individuals will last 4 months. Assessments will occur at baseline, and     weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second     scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12.     All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will     include a taper).   "
45043|NCT02696083|"     To investigate the effect of PEMF treatment when administered twice daily over a 90-day     period by looking at synovial fluid in subjects with osteoarthritis of the knee.   "
45044|NCT02696070|"     This study is designed to evaluate the effectiveness of the Provant Therapy System in     improving localized nerve growth and skin perfusion in subjects with painful peripheral     diabetic neuropathy of the foot.   "
45045|NCT02696057|"     Identification of the effects of spinal stabilization exercises and manual therapy methods on     pain, function and quality of life in individuals with low back pain.   "
45046|NCT02696044|"     The aim of this study is to evaluate the safety and tolerability of triheptanoin in     participants with Rett syndrome using laboratory values, electrocardiogram, rate of adverse     events (AE), and physical exam.This study also seeks to evaluate the efficacy of UX007     (triheptanoin) in improving overall seizure frequency and dystonia.   "
45047|NCT02696031|"     To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to     placebo in patients with non-radiographic axial spondyloarthritis at Week 16 as well as week     52 and long term efficacy and safety up to Week 104.   "
45048|NCT02696018|"     Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on     respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been     introduced in the clinical practice to evaluate diaphragmatic function. In particular, the     investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography.     The aim of this study was to compare the diaphragmatic displacement with traditional weaning     parameters in potentially ready to be extubated patients undergoing a spontaneous breathing     trial (SBT).   "
45049|NCT02696005|"     30 patients suffering from Heart Failure with Ejection Fraction less than 40% start Cardiac     Rehabilitation Programme, serum KLOTHO Hormone level and other labs and Echo measurements     will be taken on the first visit.      After completion of 3-month Rehabilitation Programme the second set of labs and Echo     measurements will be taken.      Than participants will be divided for 2 groups: the patients who wish to continue     Rehabilitation programme for additional 3-month period and the second group that prefer to     stop Rehabilitation programme after completion of the first 3 month period.      For both groups additional set of labs will be taken this time and at the end of the study.      The Aim of the study: to investigate association between serum KLOTHO level, physical     activity and possible correlation with laboratory and echocardiographic parameters in cohort     of Heart Failure patients.   "
45080|NCT02695602|"     This is a prospective, patient blinded, randomized, clinical trial enrolling patients with     symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose     of this study is to compare two different surgical methods, both of which are already in     common use, for the treatment of nasal obstruction in patients with inferior turbinate     hypertrophy.   "
45050|NCT02695992|"     The RATAF II study is a randomized, prospective, parallel group study, designed to compare     the effects of two different drug regimens for rate control in permanent AF (atrial     fibrillation). We will investigate on the difference in effects on exercise capacity,     biomarkers (NT-proBNP (N-terminal pro-brain natriuretic peptide), troponins, hs-CRP), heart     rate, echocardiographic measurements and symptoms.      Our main hypothesis is that six months' treatment with the calcium channel blocker diltiazem     will lower NT-proBNP and increase exercise capacity (peak VO2) compared to treatment with the     beta blocker metoprolol in permanent AF.   "
45051|NCT02695979|"     Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic     liver transplantation.   "
45052|NCT02695966|"     This is a single-centre, prospective, non-randomised research study. The research team will     investigate the feasibility of assessing primary human pancreatic tissue for changes to T     lymphocyte function and localisation in the presence and absence of AMD3100.   "
45053|NCT02695953|"     Posttraumatic stress disorder (PTSD) is a significant personal and societal burden. The     purpose of this study is to examine genetic, epigenetic, behavioral, and brain activity     changes related to PTSD dysfunction and recovery before and after treatment with Cognitive     Processing Therapy.   "
45054|NCT02695940|"     This is a phase 2a trial testing twice daily administration of LEO 124249 ointment 30 mg/g in     the treatment of mild to moderate inverse psoriasis. Patients will be treated for 6 weeks,     and the efficacy and safety will be compared with the treatment of LEO 124249 ointment     vehicle.   "
45055|NCT02695927|"     This project is designed to test a lightweight, portable, computerized pair of glasses that     will help reduce some of the cognitive deficits seen in patients who have suffered damage to     their right cerebral hemisphere.   "
45056|NCT02695914|"     The purpose of this study is to observe inflammatory markers like TNF (tumor necrosis     factor), IL-1 (interleukin-1), IL-6 (interleukin-6),TREM-1 (triggering receptor expressed on     myeloid cells-1), etc, in patient of FUO with excess-heat syndrome and the influence of     Compound Qingre Granule on the inflammatory markers.   "
45057|NCT02695901|"     Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis     and reducing biofilm formation, the side effects of a long-term use are unpleasant for     patients. Melaleuca alternifolia oil has been considered as an alternative because of its     anti-inflammatory properties. However, little is know about the efficacy of its     nanoparticles. The purpose of this study is to compare the effect of 0.12% chlorhexidine     (Periogard ®) and a nanoparticle solution of 0.3% M. alternifolia oil in reducing biofilm     formation in plaque-free and plaque-covered teeth surfaces.   "
45070|NCT02695732|"     To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary     Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.   "
45059|NCT02695875|"     Fibromyalgia is a disease whose incidence rate is increasing and causing a severe disability     to those who suffer it. Currently, other treatment resources are being implemented, such as     aquatic therapy. This therapy seems to provide positive results in different dimensions of     fibromyalgia.      The main objective of the study is to determine the effectiveness of a physical therapy     program in warm water vs. land-based therapy in women with fibromyalgia for pain reduction     and improvement balance at the end of treatment and a month and a half later (follow-up).      The type of study is a randomized controlled opened trial. The sample is composed of 34 women     with age between 35 and 64 years and fibromyalgia diagnosis who will be divided into 2     groups: Aquatic Therapy Group (n=17) and Land-Based Therapy Group (n=17). This study will     have two primary outcomes: Pain and balance. The intensity of pain will be assessed using the     visual analog scale (VAS) and the pain threshold for each one of the 18 tender points will be     assessed using a electronic algometer. Static balance will be evaluated with the Romberg's     test and the dynamic balance with the Timed Up & Go test (TUG) and Berg Balance Scale. Both     type of balance will be recorded in slow motion and then, will be analysed with a motion     software. Secondary outcomes are: The impact of fibromyalgia on patient's lives, that will be     measured with the Revised Fibromyalgia Impact Questionnaire (FIQR); the sleep quality, that     will be assessed with the Pittsburgh Sleep Quality Index (PSQI); the fatigue, that will be     evaluated witn the Multidimensional Fatigue Inventory (MFI); the physical capacity, that     will be measured with the six minute walk test (SMWT) and confidence in balance that will     be assessed with the Activities-specific Balance Confidence scale (ABC).      Each intervention will last one hour and will be made 3 times a week for three months . It     will consist of 4 sections: Warming, exercises for static and dynamic balance training,     stretching and relaxation. Statistical analysis will be made using the Statistical Package     for the Social Sciences software, version 21.0 for Windows. p ≤ 0.05 will be the significance     level set for all analysis.   "
45060|NCT02695862|"     The study is single centered; prospective, parallel arm randomized controlled trial.The     patients will be who presented to Institute of Liver & Biliary Sciences with esophageal     variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be     managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac     rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every     6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will     checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl.     Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg)     followed by Endoscopic variceal ligation. All patients will received prophylactic     antibiotics; antibiotics will be stopped if there will no other indication to continue. After     confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with     emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into     Group -A (Bolus terlipressin at 1mg every 4hourly) and Group-B (Continuous infusion of     terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo     HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient     in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient)     measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS     (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.   "
45061|NCT02695849|"     This is a non-interventional, local, multicenter, cross-sectional study to determine the     prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed     with non-squamous non-small cell lung cancer (NSCLC).   "
45091|NCT02695446|"     The primary objective of this study is to evaluate the skin and plasma concentrations of     minocycline in subjects undergoing treatment of acne vulgaris with oral extended release     minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.   "
45092|NCT02695433|"     The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week     (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control     treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite     index of insulin sensitivity (MISI).   "
45062|NCT02695836|"     This project will evaluate three different strategies to get research findings back to     managers of care units in nursing homes. Feedback will be provided in a timely and effective     way so that it results in improvements in organizational context (modifiable features of the     care unit work environment, such as Formal Interactions, Informal Interactions, Social     Capital or Slack Time), quality of care providers' work life (e.g., burnout, job     satisfaction, general health) and quality of care. Three feedback packages will be tested to     determine the strategy that is most effective at fostering improvements and is also     cost-effective. The project will be carried out in nursing homes in Alberta and British     Columbia. The information developed will contribute to better care for Canadian seniors who     spend their final years in a nursing home.   "
45063|NCT02695823|"     Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain     physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may     occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault.     In addition, intracranial hypertension measured with invasive methods has been described in     certain phases of LT, especially at the time of reperfusion.      The invasive monitoring of the intracranial pressure is not used in these patients, due to a     high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has     been widely developed in recent years : transcranial doppler and recently ultrasound of the     optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.   "
45064|NCT02695810|"     The overall objective is to compare the short-term (3 months) effectiveness of three     glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose     variability, body composition, and cardiometabolic risk factors in overweight or obese     individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).   "
45065|NCT02695797|"     The purpose of the study is to investigate effect of immunotherapy in intractable cryptogenic     epilepsy patients with autoimmune antibody.   "
45066|NCT02695784|"     The influence of the preterm gut microbiota in health and disease has been well established.     However, relatively little is known about how the microbiome changes after discharge and its     relationship with growth, health and disease outcomes in the preterm population. This study     aims to follow a cohort of preterm infants and explore the relationship of the later     microbiome ('after discharge') with later growth and health outcomes in infancy. The study     will also explore the effect of timing of stopping routinely administered probiotics on the     post-discharge microbiome, infant feeding and outcomes such as colic.      The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who     have also taken part in the investigators microbiome study during their NICU stay (SERVIS REC     No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The     investigators will collect stool at and beyond the time of anticipated discharge (beyond 34     weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge     timing of these infants varies, and is usually latest in the most immature infants, allowing     an assessment of the influence of physical location (NICU vs home) as well as increasing age.     Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial     colonisation of the gut and measure infant weight, length and head circumference at each time     point. The investigators will use a parent questionnaire to assess daily crying time,     parents' perceptions of colic severity using a visual analogue scale as well as vomiting and     constipation for the two weeks before sampling.   "
45072|NCT02695706|"     The measured product in this research is a product for topical use, Laboratoires     Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the     improvement in skin hydration as measured by self perception of participant research and     clinical evaluation and improvement in local microcirculation, assessed by instrumental     measurements in feet of the study participants.   "
45073|NCT02695693|"     Computer assisted interventions are becoming very popular as an intervention strategy for     students with autism. There is little data on how effective they are or how their     implementation affects teachers' use of other evidence-based practices. The proposed study     would be the first to examine these questions in a community setting.   "
45074|NCT02695680|"     Real-time optical surface monitoring data will be acquired from 44 human patients with     primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our     institution). A patient-specific 4D model will be developed using the raw 4DCT projections     time-correlated with real-time surface monitoring. In addition, before delivering each dose     fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions,     time-correlated with optical surface monitoring. The acquisitions will be distributed over     three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.   "
45075|NCT02695667|"     Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the     clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive,     and CPAP Responsive   "
45076|NCT02695654|"     Adductor canal block has become popular as effective mean for pain relief following knee     surgery.This block has not been checked in chronic pain patients.The purpose of this study is     to assess the efficacy and safety of adductor canal block on chronic knee pain in patients     with knee osteoarthritis.   "
45077|NCT02695641|"     The primary purpose of this pilot study is to assess the pharmacokinetic profile of low-dose     bevacizumab and its effectiveness in reducing plasma free VEGF-A levels safely in     hemodialysis patients. This information will be used to plan a phase 1 clinical trial     evaluating bevacizumab's role in hemodialysis vascular access failure.   "
45078|NCT02695628|"     This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission     tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in     imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks     blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor.     [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that     have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET     scan and this may help researchers learn whether changes occur in the tumors after treatment,     which can help decide how well the treatment worked earlier than is currently possible   "
45079|NCT02695615|"     We investigated a correlation between maternal anxiety and age, body mass index (BMI),     parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to     emergent or elective C/S under general anesthesia.   "
45081|NCT02695576|"     Title and abstract      1 a. Title: Lumbar fusion or non-operative care for treatment of presumed discogenic pain.      A randomized study.      1 b. Structured summary:      Authors: B. Nyström, B. Schillberg, E. Svensson, T. Stiles.      Corresponding author: Bo Nyström, Clinic of Spinal Surgery, Strängnäs, Sweden. e-mail     address: pgbo.nystrom@gmail.com      Background: At present there is no clear evidence that surgical treatment by fusion operation     is more advisable than non-surgical treatment in patients suffering from unspecific chronic     low back pain (CLBP). By personal experience a subgroup among the CLBP patients is selected,     possibly representing patients with pain from a motion segment/disc, thus making patient     selection more specified. Furthermore, selection of level to fuse based on radiological     findings has not been found reliable. Therefore a mechanical provocation test has been     developed at the clinic. The aim of this randomized study was to compare the outcomes in pain     and pain related functions perceived by this specific subgroup of CLBP patients following     fusion surgery with those following non-surgical treatment.      Methods: Patients with a specified symptomatology and specified clinical signs at examination     were recruited and randomized to either type of treatment, non-surgical (NS) including     cognitive-behavioral therapy and physiotherapy (37 pat.) or surgical (S), including the same     cognitive-behavioral therapy and physiotherapy as in the NS group plus fusion surgery (37     pat.). All patients were thoroughly investigated before start of the study and at follow-up     one year after treatment. The outcomes perceived by the patients were assessed on the     validated questionnaires Oswestry Disability Index (ODI), Roland-Morris, Balanced Inventory     for Spinal Disorders (BIS), Short-Form-36 (SF-36) and Euro-Quol (EQ-5D).   "
45082|NCT02695563|"     The aim of the study is to evaluate the effect of vaginal lactoferrin administration on     amniotic fluid PGE2 level and MMP-TIMP system in women undergoing genetic amniocentesis. Two     groups of patients will be prospectively enrolled: not treated with lactoferrin and treated     with vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.   "
45083|NCT02695550|"     This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive     non-small cell lung cancer.      The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707     is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.   "
45084|NCT02695537|"     The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various     doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating     debilitating, drug-resistant epilepsy.   "
45085|NCT02695524|"     This study evaluate the effectiveness of adding neuromuscular exercises with tactile, visual     and auditory feedback to a strengthening exercises protocol, both emphasizing the     periscapular muscles on improvement of disability in patients with shoulder impingement     compared to patients receiving only strengthening exercise protocol.   "
45086|NCT02695511|"     The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure     whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in     normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and     sleeping) will be measured in a respiratory chamber. Other measures include the activities of     the sympathetic nervous and thyroid axes, oxidative stress in lipids, protein and DNA, organ     size by MRI and echocardiography, and posture allocation (time spent engaging in different     activities and the energy expended during these activities), and activity temperament (the     innate predilection for movement). This set of studies will allow assessment of whether the     previously observed metabolic adaptation in response to 25% caloric restriction is long     lasting (up to two years), associated with reduced thyroid and sympathetic activities and     reduced oxidative damage. The studies of organ sizes (liver, spleen, kidney, heart, adipose     and muscle) by MRI and echo (heart) is essential to determine whether the metabolic     adaptation is related to decreased organ sizes or improved organ energy metabolism     efficiency. The above described measures will be performed at baseline and after 1 and 2     years of a 25% caloric restriction in 50 non-obese humans and in 25 sex-, BMI- and age-     matched subjects who will not engage in caloric restriction.   "
45087|NCT02695498|"     Although many adults with migraines use non-pharmacological treatment options, there is a     lack of research on the use of many mind/body techniques specifically for headache. This     research will further the understanding of the mechanisms, efficacy, and predictors of     mind-body practices in adults with migraines.   "
45088|NCT02695485|"     A retrospective study is conducted with 151 patients who has a soft tissue defect of digit     treated with the sensate flaps from February 2005 to March 2014. Based on the different     regions of soft tissue defects, the patients in the study are divided into four groups: (1)     thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal     finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal     finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region     group treated with Litter flap. The main outcomes are static 2-point discrimination and     Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.   "
45089|NCT02695472|"     The study will consist of a screening period and a randomized treatment. Approximately 220     subjects who meet eligibility during the screening period will be randomized to initiate a     12-week, double-blind treatment with NSI-189 80 milligrams/day (provided as 40 milligrams     twice per day), NSI-189 40 milligrams once a day, or placebo.   "
45090|NCT02695459|"     Phase II, open-label, multicentre national study. Patients with metastatic neuroendocrine     carcinomas of extrapulmonary origin will be eligible. Treatment will be performed as     indicated in the section Investigational drug and reference therapy. Cisplatinum and     everolimus dosing is based upon earlier phase 1 studies (Fury et al. 2012). CTs will be done     at 9 weekly intervals (after 3 courses of chemotherapy;). Patients will be treated until     documented progression according to RECIST 1.1. Enrolment is expected to take between 14 - 16     months. The total study duration is estimated to be 2 to 3 years until publication. Three NET     centres in The Netherlands will participate, (Erasmus Medical Center in Rotterdam,     Netherlands Cancer Institute in Amsterdam and , the University Medical Center of Groningen) A     pre-treatment (and optional post-treatment) tumour biopsy will be included for DNA/RNA     analyses and organoid culture. An additional 5cc of blood will be withdrawn as a germline DNA     reference. A second 5 cc of blood will be included for measuring circulating tumour     transcripts to identify all types of GEP-NET (NETTest).   "
45094|NCT02695407|"     Cardiac output monitoring devices are commonly used in ICU patients. The most precise use     direct measurement, which require artery cannulation. The gold standard is Swan-Ganz     catheter, but it is a very invasive technique. PiCCO (Pulse index Continuous Cardiac Output)     is the alternative way of haemodynamic monitoring. This technology is the easy, less invasive     and cost-efficient tool for determining the main hemodynamic parameters of critically ill     patients. It is based on two physical principles - transpulmonary thermodilution and pulse     contour analysis. Both principles allow the calculation of haemodynamic parameters in     critically ill patients. PiCCO method requires peripheral artery cannulation.      Cannulation may be followed by artery stenosis.      Aims of the study are:        1. to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO          cannula in place.        2. whether 5 days cannulation of radial artery with PiCCO catheter is related to more          frequent stenosis rate.      An additional assessment:      1. to check whether the eventual stenosis is still present after 3, 14 and 30 days after     decannulation - assessment depending on patients availability   "
45095|NCT02695394|"     The aim of this prospective non-interventional neuropsychological one visit study involving     functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple     Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.      In different experiments, the modulation of cognitive and motor responses by visual emotional     information and the ability to discriminate visual emotional stimuli will be tested using     experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI -     activations of brain regions known to be involved with emotional processing will be     evaluated.   "
45096|NCT02695381|"     This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one     time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness     (DOMS) of the upper limbs.   "
45097|NCT02695368|"     The study is a multicenter, double-blind, randomized, controlled trial conducted at three     major university and teaching hospitals with a catchment population of approximately 1     million. In the current study it has been hypothesized that a non-invasive air cleaner     utilizing a plasma chamber can significantly reduce the incidence of surgical site infections     (SSIs).   "
45098|NCT02695355|"     The purpose of this study was to see if the clinical outcome of stimulant medication     (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on     the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant     medication. (ERPs are extracted from electroencephalographic (EEG) registrations during the     performance of an attention task).   "
45099|NCT02695342|"     There is a growing body of evidence demonstrating that older adults with COPD have important     problems with their balance and a high incidence of falls compared to those of a similar age.     This research will explore the feasibility and preliminary effects of a tailored 6-month home     balance exercise program for reducing falls in older adults with COPD.   "
45100|NCT02695329|"     Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of     precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment     compared to conventional instruments   "
45101|NCT02695316|"     The aim of this study is to describe access and communication barriers of migrant women who     do not speak the local language in the Swiss maternity care service provision from the     perspective of users, health care professionals and interpreters.   "
45102|NCT02695303|"     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.   "
45103|NCT02695290|"     There is a medical need for improving treatment of poor performance status patients with EGFR     driver mutations and documenting safety and tolerability of existing agents.   "
45104|NCT02695277|"     This is a prospective, randomized (2:1) multicenter trial to investigate the optimal     treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF)     ablation.The study objective is to compare the efficacy and safety of two interventional     approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with     persistent or longstanding persistent atrial fibrillation.   "
45105|NCT02695264|"     The purpose of this study is to prospectively evaluate the accuracy and safety of     non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000)     device compared to the current invasive external ventricular device (EVD) or parenchymal     (bolt) monitoring devices in the pediatric population.   "
45106|NCT02695251|"     Renal functional reserve is defined as the glomerular hyper filtration induced by a protein     load. Renal blood flow and Glomerular Filtration Rate (GFR) increase in response to a protein     load. Renal functional reserve loss is associated with a persistent hyper filtration state,     seen in first stages of diabetic nephropathy, leading to progression of Chronic Kidney     Disease (CKD). This observation has lead to larger clinical studies that demonstrated the     positive effects of protein restriction on kidney function, and allowed the scientific     community to recommend low proteins diet (less than 0.8 g / kg/ day) to prevent CKD     progression. Nevertheless, the precise mechanisms responsible for kidney hemodynamic and     metabolic changes induced by a protein load, are debated. Uribarri et al have suggested that     renal hemodynamic changes induced by a protein load are mainly due to the Advanced Glycation     End Products (AGEs) content. Indeed, initial studies experimental conditions leading to the     demonstration of renal functional reserve (amino acid or protein perfusion or cooked meat),     were in fact responsible for an AGEs load, based on recent published data.      The aim of this study is to determine whether AGEs alone or proteins in general are     responsible for the mobilization of renal functional reserve, leading to the progression of     CKD.   "
45107|NCT02695238|"     Superiority multicenter prospective randomized study on operative delivery (instrumental     delivery or caesarean section) of prophylactic manual rotation in case of persistent     occipital posterior presentation during the second stage of labor compared to expectant     management. A 15% reduction of operative delivery (instrumental delivery or caesarean     section) is attempt in the prophylactic manual rotation group.   "
45134|NCT02694874|"     Even with optimal anti-malaria therapy and supportive care, severe and cerebral malaria are     associated with a 10-30% mortality rate and neurocognitive deficits in up to 33% of     survivors. Adjunctive therapies that modify host immune-pathological processes may further     improve outcome over that possible with anti-malarials alone. Investigators aim to evaluate a     PPARγ agonist ( rosiglitazone) as adjunctive therapy for severe malaria.   "
45108|NCT02695225|"     Tobacco use remains a significant public health problem and is increasingly prevalent among     vulnerable groups. Appalachians have a high prevalence of tobacco use and are at increased     risk for tobacco-attributable diseases. The efficacy of a scientifically valid tobacco     cessation treatment delivered to Appalachian smokers remains untested. Also, little is known     about the association of social-contextual factors that may modify or mediate the success of     an intervention. These factors may be of particular relevance among disadvantaged smokers.     Geographical patterns of tobacco exposure may also influence one's ability to quit,     especially in pro- tobacco regions like Appalachia. The purposes of this application are to:     1) evaluate the efficacy of a lay-led (LL) intervention in promoting long term abstinence     from tobacco; and 2) examine the association between 12 month abstinence and selected     individual, interpersonal, organizational, neighborhood and community, and societal factors     among adult Appalachian tobacco users exposed to a tobacco cessation intervention. A third     aim is exploratory and includes the characterization of activity patterns using space-time     measures among adult Appalachian tobacco users exposed to a tobacco cessation intervention.     Using a group randomized trial design, 707 Appalachian residents from 6 intervention and 6     control counties will be randomly assigned by county to receive the LL intervention or a     control condition which includes proactive telephone counseling via the Ohio Quit Line. LL     group participants will receive face-to-face counseling, supervised by a county health     department nurse, and delivered by a trained lay educator. A county Extension agent will     assist with recruitment and retention efforts in this project. Social-contextual factors will     be assessed at a baseline interview administered to all participants. Space-time activity     geographical patterns of pro- and anti-tobacco exposures, or features, will be described     among selected participants in four counties during weeks 1, 6 and 12 of treatment. At end of     treatment and 6 and 12 months, LL and control group participants will be reassessed for     tobacco use via self-report and cotinine-validation. Secondary analyses will explore     differential trends over time between the two arms of the study. In a subset of the sample,     pro- and anti-tobacco exposures will be estimated during weeks 1, 6 and 12 of treatment.   "
45109|NCT02695212|"     The primary objective of this study is to evaluate the safety and efficacy of Apremilast in     subjects with moderate Hidradenitis Suppurativa (HS).   "
45110|NCT02695199|"     To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic     varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted     LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with     varicoceles.   "
45122|NCT02695030|"     The MicroVention Low-profile Visualized Intraluminal Support (LVIS*) Device is intended for     use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck greater     than or equal to 4 or a dome to neck ratio less than two), intracranial, saccular aneurysms     arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than     or equal to 4.5mm.   "
45111|NCT02695186|"     Intestinal metaplasia is generally considered a precancerous lesion. Although it is     associated with a very small increase of gastric cancer risk, European Endoscopic Society and     other European academic companies highlighted the increased risk of cancer in patients with     gastric atrophy and IM and the need for staging in cases with high-grade dysplasia.      The production of ROS in the gastrointestinal tract (GI) and their role in the     pathophysiology and pathogenesis of gastrointestinal diseases have not been studied     sufficiently. In the plasma of patients, in the context of the sequence gastro oesophageal     reflux-oesophagitis-metaplasia-dysplasia-adenocarcinoma, have been found simultaneous     formation of DNA adducts and increased myeloperoxidase concentration, which are associated     with oxidative stress, decreased antioxidant capacity (decreased glutathione     concentration).These findings support the role of oxidative stress in the pathogenesis and     malignant transformation.      Metabolic Syndrome (MS) has been recognized as a pro-inflammatory, pro-coagulant state     associated with increased levels of C reactive protein (CRP), interleukin (IL) 6 and     plasminogen activator inhibitor (PAI) 1. It has been reported that the inflammatory and the     pro thrombotic markers, which are associated with increased risk for cardiovascular disease     and DM2, represent only a part of the relationship between IM and cardiovascular mortality.      Several factors influence the pathogenesis of MS, as the pro-oxidant condition of such     patients may increase the risk for developing symptoms and related chronic diseases such as     DM2. Although the exact contribution of oxidative stress on every pathologic condition     included in MS is difficult to determine definitively, it is certain that oxidative stress is     particularly high in the MS.      Regarding the relationship between MS and GI diseases, studies have reported that patients     with MS are almost twice at risk for developing Barrett's esophagus.The relationship between     MS, gastro-esophageal reflux disease (GERD), and the development of IM also requires well     designed prospective studies. It seems however, to be a correlation between obesity and GERD,     as well as between obesity and gastric adenocarcinoma   "
45112|NCT02695173|"     The objective of this study is to compare, by insulin use at the index date, the sex-specific     incidence of hospitalization or emergency department (ED) visit for severe complications of     urinary tract infections (UTI), defined as pyelonephritis and urosepsis, among patients with     type 2 diabetes mellitus (T2DM) who are new users of dapagliflozin with those who are new     users of antidiabetic drugs (ADs) in classes other than sodium-glucose cotransporter 2     (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.   "
45113|NCT02695160|"     The purpose of the study is to evaluate the safety, tolerability and effect on FIX antigen     and activity levels of ascending doses of SB-FIX. SB-FIX is an intravenously delivered Zinc     Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts a correct copy of the Factor     9 gene into the albumin locus in hepatocytes with the goal of lifelong therapeutic production     of the Factor IX clotting factor.   "
45114|NCT02695147|"     A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or     direct aortic approach between January 2011 and January 2016   "
45115|NCT02695134|"     The purpose of the investigators proposed randomized, controlled study is to examine the     effect of 6 one hour treatments of Healing Touch (HT) over 3 weeks on post-cardiac event     patients, while they wait to enter a Cardiac Rehab (CR) program.Patients enrolled in the     Scripps Center for Integrative Medicine (SCIM) Cardiac Rehab Program typically experience a     waiting period of 3 weeks, or sometimes more, before starting the program.      Secondary aims of the proposed study are to evaluate the effect of HT on CR program outcome     measures of METs, BMI, physical and mental well-being, and attendance in this population.      New participants in the CR program who qualify and agree to participate in the study will be     consented and randomly assigned to the Intervention Group who will receive Healing Touch     therapy, or to the Control Group, which will not receive HT.      At baseline both groups will complete the Dartmouth Quality of Life and SF-36 Health Surveys.     The questionnaires will be repeated at the end of the 3 week study period and at the end of     the 3 months SCIM CR program.      An effect size of 15% was chosen, with an alpha level of 0.05, 80% power, 95% confidence     level, and using a two-tailed test, it was determined that a sample size of 56 patients in     each group would be needed for between group comparisons. To account for potential attrition     the study will enroll 124 subjects, 62 in each group.      Our rationale is that Healing Touch, in addition to standard medical care will reduce     post-cardiac event stress and anxiety symptoms in patients waiting to enter a cardiac rehab     program, as measured by the Dartmouth Quality of Life Index and the SF36 questionnaire.     Further, the investigators suggest that Healing Touch treatments will improve patient's final     outcomes of the 12 week CR program.   "
45388|NCT02691546|"     The SCOPE study is an observational, multicenter, prospective cohort study aimed at     evaluating a 2-year screening programme for CKD in a population of older patients, aged 75     years or more, in seven European Countries, in an attempt to investigate whether and to which     extent currently available screening methods may identify older people at risk of worsening     kidney function.   "
45116|NCT02695121|"     The primary objectives of this study are (1) to compare the incidence of breast cancer, by     insulin use at cohort entry, among females with type 2 diabetes who are new users of     dapagliflozin and females who are new users of antidiabetic drugs (ADs) in classes other than     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin     monotherapy, or sulfonylurea monotherapy and (2) to compare the incidence of bladder cancer,     by insulin use at cohort entry and pioglitazone use, among male and female patients with type     2 diabetes who are new users of dapagliflozin and those who are new users of ADs in classes     other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea     monotherapy. Secondary objectives will compare, by insulin use at cohort entry, frequency of     several measures of health care use, baseline characteristics, and incidence of selected     other cancers in males and females between the two exposure cohorts.   "
45117|NCT02695108|"     Neck pain is a very common problem in the population. Most of the patients suffer from neck     pain for long time and the problem becomes chronic. The investigators studied the effects of     scapular stabilization exercise on mechanical neck pain.   "
45118|NCT02695095|"     To compare, by insulin use at the index date, the incidence of hospitalization for acute     liver injury (ALI) among patients with type 2 diabetes mellitus who are new users of     dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin     monotherapy, or sulfonylurea monotherapy.   "
45119|NCT02695082|"     To compare, by insulin use at the index date, the incidence of hospitalization for acute     kidney injury (AKI) among patients with type 2 diabetes mellitus who are new users of     dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin     monotherapy, or sulfonylurea monotherapy.   "
45120|NCT02695069|"     The purpose of this study is to assess the efficacy of random placenta margin incision for     hemorrhage control during cesarean section of complete placenta previa pregnancies.   "
45121|NCT02695043|"     The primary purpose of this research is to increase adherence to outpatient rehabilitation of     chronically underserved individuals with traumatic brain injury (TBI). The intervention will     be a TBI rehabilitation-focused education tool suitable for use with a wide variety of     patients, including those with poor literacy skills and those with Limited English     Proficiency (LEP), hereafter referred to as the Multimedia Multicultural Educational Program     for TBI (MMEPT).   "
45123|NCT02695017|"     The investigator will proceed to assess changes in oxygenation of muscle tissue,     electromyographic activation and strength in healthy subjects. For this, a measurement of all     demographic variables on the first day of the study as well as a familiarity with the     equipment will be performed. Participants will start the intervention 48 hours later to     proceed with the first intervention with one of the exercises in this research (inertial     pulley or regular machine). Later on, 48 hours later participants will perform the latest     intervention that has not yet done, thus generating a crossover study.   "
45124|NCT02695004|"     This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy     male volunteers.   "
45125|NCT02694991|"     Effectively controlling sternal pain during cardiac rehabilitation after heart surgery is     very important as it reduces the risk of postoperative complications.      However, the contraindications and side effects of analgesic drugs may induce physicians to     use them so cautiously that pain may actually be under-treated.      The aim of this open label, controlled study is to assess whether osteopathic manipulative     treatment (OMT) can contribute to pain relief and improve rehabilitation outcomes.   "
45126|NCT02694978|"     To evaluate the safety of 1.020 g of IV ferumoxytol compared to 1.500 g of IV Ferric     Carboxymaltose (FCM).   "
45127|NCT02694965|"     Purpose of the study:      The investigators are proposing that melanomas which respond and develop eventual disease     stability in response to checkpoint inhibitor immunotherapy undergo a genetic program     promoting secondary resistance.   "
45128|NCT02694952|"     Interventional, individually randomized, double (e.g. investigator and participant) blinded,     parallel two-arm, non-inferiority trial to assess the efficacy of EchiTabPlus-ICP compared to     FAV-Africa for the treatment of snakebite with envenoming.   "
45129|NCT02694939|"     The proposed study evaluates the effectiveness of a family-based psychosocial treatment     program for teens with ADHD (Supporting Teens' Academic Needs Daily; STAND) developed to be     delivered in community settings. STAND is BT enhanced by Motivational Interviewing (MI) that     was developed (R34 MH092466) for teens with ADHD through a stakeholder informed process.     STAND consists of ten 50-minute sessions delivered by therapists with community-typical     levels of training and supervision. Across randomized controlled pilot (N=28; N=36) and     efficacy trials (N=128), STAND demonstrates medium to large effects on ADHD and ODD symptoms     and indices of academic and family impairment. In the proposed study, 240 adolescents with     ADHD who present for treatment at one of four community mental health agencies in Miami-Dade     County, FL will be randomly assigned to STAND or agency usual care (UC). Participating agency     therapists also will be randomly assigned to deliver STAND or UC. STAND therapists will     receive a comprehensive treatment manual, three-day training, and weekly supervision from a     project psychologist. Participants will be screened by research staff in the community     setting and enrolled on a rolling basis over 30 months. Participants will be assessed at     baseline, post-treatment, and three-month follow-up. In line with RDoC, multi-method measures     will be obtained for treatment outcome (family and academic impairment), treatment mediators     (executive functioning, parent academic involvement, parent-teen communication,     parent/adolescent motivation, ADHD symptoms), and moderators of effectiveness (patient,     practitioner, service delivery, and organization characteristics). Additional consumer     perspective (satisfaction, therapeutic alliance) and agency fit (therapist competence,     treatment fidelity, need for additional treatment, attendance, therapist attitude toward     treatment, cost effectiveness) measures will also be obtained to evaluate effectiveness. We     will recruit an ethnically diverse sample (65% Hispanic, 19% African-American, 16%     Non-Hispanic White) that is historically underrepresented in research, but ideal for     evaluating therapy effectiveness.   "
45130|NCT02694926|"     Even under established replacement therapy, patients with adrenal insufficiency still suffer     from impaired quality of life and experience adrenal crises. Patient education is regarded as     important preventive measure. In this study a german-wide standardized education Programme     will be evaluated.   "
45131|NCT02694913|"     This is a non-interventional, R01-funded pilot study that will identify serum and cellular     markers in patients' blood samples that can be used as short-term biomarkers of rituximab     response. We hypothesize that serum complement levels, activation of natural killer cells,     and clearance of peripheral B-cells will be accurate biomarkers of rituximab response, and     may be correlated with long-term outcomes.   "
45135|NCT02694861|"     The purpose of this study it to collect real world 30-day and 1-year follow-up data for     patients undergoing TMR with the CardioGenesis Holmium:YAG Laser System either as a sole     therapy procedure or in conjunction with coronary artery bypass graft (CABG) surgery.      The primary objective of this study is to provide ongoing clinical data regarding the     characteristics of the patient population undergoing TMR in community practices. Secondary     objectives include rates of postoperative mortality and MACE at 30-days and 1-year, and     benefit of sustained improvement in angina at 30-days and 1-year.      The study includes two patient populations:        -  Registry Group: Patients from selected centers who previously participated in the ANGINA          RELIEF Registry and are eligible for a one-year, prospective follow-up;        -  Prospective Group: Up to 100 new, prospectively enrolled TMR patients from selected          centers.   "
45136|NCT02694848|"     To evaluate the therapeutic evaluation of combination therapy with aspirin and salvianolate     injection based on the population pharmacokinetics and TEG.A prospective, multicenter,     randomized, controlled clinical trial is used.A total of 120 patients will be recruited and     will be divided into three groups,respectively salvianolate injection group,aspirin group and     salvianolate injection and aspirin group，and the course of treatment is 10 days.   "
45137|NCT02693795|"     Left ventricular (LV) remodeling following myocardial infarction (MI) is an established     prognostic factor for adverse cardiovascular events and the leading cause of heart failure.     Empirical observations suggests that Baduanjin exercise, an important component of     traditional Chinese Qigong, exert potential impacts on cardiopulmonary function. However, the     impact of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering     from recent MI has yet to be assessed. The aim of this trail is to evaluate whether Baduanjin     exercise would prevent the maladaptive progression to adverse LV remodeling in patients     following MI.   "
45138|NCT02693782|"     This is a placebo controlled, cross-over, randomized, double blinded study. The intervention     food products will be taken as diet prebiotic supplements: 1. Wheat Bran Extract rich in     arabinoxylan oligosaccharides : 15g/d (up to 10 g total additional dietary fibre per day). 2.     Placebo product maltodextrin:equal amounts of a digestible carbohydrate.      Primary endpoints are faecal microbiota analysis and faecal metabolite analysis     (particularly, short chain fatty acid). Secondary endpoint is serum cholesterol, glucose, HDL     and bowel function, gastrointestinal tolerance, quality of life and food frequency (by the     use of questionnaires).   "
45139|NCT02693769|"     The purpose of this study is to investigate whether fluticasone/formoterol Breath actuated     inhaler is effective and well tolerated in the treatment of subjects with fixed airflow     obstruction and elevated eosinophils.   "
45140|NCT02693756|"     Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in     patients with neurological diseases or in healthy elderly persons with exercises.      There is evidence that mental practice, also called motor imagery, the imagination of     performing a movement, can also improve an activity or balance. The effective performance and     the imagination of a task activates some overlapping central areas and neural networks, which     might explain the improvements after motor imagery.      The investigators set out to test the feasibility of such a study using an open label     randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is to     evaluate whether the instructions are clear, the intervention and the study procedures are     acceptable and to assess the proportion of participants withdraw from the study (drop outs).     Secondary aims are the assessment of between group differences in the changes of the gait     stability.   "
45141|NCT02693743|"     Suicide was responsible for almost 40,000 deaths in 2011 in America. It is still singularly     difficult to predict who is going to commit suicide and how to establish adequate     interventions. Growing evidence supports the view that suicide is associated with poor     decision making. Suicide is hypothesized to be triggered by stressful situations that create     overwhelming psychological pain in an individual who chooses to terminate his/her own life,     disregarding all future consequences. We have previously demonstrated rewarding impulsive     choice common to both recent suicide attempters and suicidal depressed patients (1).     Consistent with these findings, we hypothesize that high frequency repetitive transcranial     magnetic stimulation (rTMS) of the left prefrontal cortex will improve impulsive response     tendencies as measured by the delay discounting procedure, and this in turn will be     associated with a faster resolution of suicidal ideation. To these effects we will be using a     randomized control trial of rTMS in adult inpatients at the Psychiatric Research Institute     (PRI) hospitalized for acute suicidality. At the conclusion of these studies, we will have     tested the value of decision making in the development of suicide ideation and behavior, as     well as piloted the use of rTMS in the treatment of these patients.   "
45142|NCT02694822|"     This is an open-label, Phase 1, multicenter study to evaluate the safety, PK, and PD of an     anti-CTLA-4 human monoclonal antibody (AGEN1884) and to estimate the MTD in subjects with     advanced or refractory cancer. The study will consist of a 3+3 dose escalation cohort     starting at a near minimally anticipated biologic effect level (MABEL) dose with expansion     cohorts at 1 mg/kg and 3 mg/kg..   "
45143|NCT02694809|"     The main purpose of this study is to determine if taking the study drug, conjugated     estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the     breast tissue of the study subjects. The study drug is approved by the US Food and Drug     Administration in healthy postmenopausal women to treat certain symptoms of menopause such as     hot flashes. Since it is not approved in women with DCIS, its use in this study is     experimental. This study will also look at whether taking the study drug causes any     significant or undesirable side effects in women with DCIS. The researchers hope that this     study will help them determine if taking the study drug is safe in women taking DCIS and if     it can possibly reduce the risk of developing breast cancer in women with DCIS.   "
45169|NCT02694471|"     This investigation aimed to compare the response of older adult and young men to 14 day     bed-rest and subsequent 28 day rehabilitation. Sixteen older (OM: 55-65 years) and seven     young men (YM: 18-30 years) were exposed to 14-day bed rest (BR) followed by 14-day     rehabilitation (R), and 400-day of R. Quadriceps muscle volume, force and explosive power of     leg extensors, single fiber isometric force, peak aerobic power, gait stride length, and     several metabolic were measured before and after BR and after R.   "
45144|NCT02694796|"     The purpose of this study is to evaluate the impact of an intervention combining a workshop     during a balneotherapy and the use after the end of the balneotherapy of a web and     smartphone-based physical activity program using connected devices, on physical activity     level among patients 12 months after they participated in a balneotherapy in thermal care     center.      A multi center randomized controlled trial is setting to evaluate the impact of the     intervention on physical activity recommendations achievement of the patients.      Investigators hypothesize that an intervention including a workshop during a balneotherapy     and an automated physical activity program using web, mobile phone and connected devices will     help patients to be engaged in more physical activities and to reach physical activity     recommendations.   "
45145|NCT02694783|"     Background:      Progressive Multifocal Leukoencephalopathy (PML) is a brain infection in people with a     weakened immune system. Researchers think polyoma virus specific T cells (PyVST) therapy can     treat PML. The PyVST cells are made from blood cells of a healthy relative. They are grown in     a lab to expand the virus-killing cells, then given to the person with PML.      Objective:      To test whether PyVST safely treats PML.      Eligibility:        -  Adults ages 18 and older with PML        -  Healthy adults ages 18 and older who have:             -  Been screened under protocol 97-H-0041             -  A sibling, parent, or child with PML and matching cells      Design:        -  Participants will be screened with:             -  Medical history             -  Physical exam             -  Blood and urine tests        -  PML participants will also be screened with:             -  Cerebrospinal fluid removed by needle in the back.             -  MRI: A dye is injected in a vein. They lie on a table that slides into a cylinder.             -  Questionnaires      Healthy participants will have apheresis: Blood flows through a needle in one arm into     machine that separates blood cells needed for donation. The rest of the blood is returned by     needle to the other arm. Some participants may have a central line placed in a vein instead.     They can have apheresis up to 3 times, at least 28 days apart.      Participants with PML will receive the PyVST cells by needle in the arm. They will stay in     the hospital 1 week. They can do this up to 3 times, at least 28 days apart. After each     infusion, they will have weekly visits for 1 month. Then they will have 4 visits over 1 year.     Visits include repeats of screening tests.   "
45146|NCT02694770|"     This study is to assess the efficacy of Neihulizumab versus conventional therapy and to     evaluate safety, pharmacokinetics and immunogenicity in treating steroid-refractory acute     Graft-vs-Host Disease   "
45149|NCT02694731|"     Participants will complete a 5-week smartphone app-based intervention that teaches mindful     eating skills. One goal is to determine to what extent participants will enjoy using the app     and complete the intervention. The investigators predict that after completing the     intervention, participants will report fewer episodes of eating in response to food cravings.     The investigators will also measure several other biological and behavioral outcomes.   "
45150|NCT02694718|"     The purpose of this study is to determine the pathological complete tumor response rate.   "
45151|NCT02694705|"     Comparison of the preoxygenation efficacy of tidal volume breathing using three different     preoxygenation techniques which are available to providers in the prehospital environment.   "
45152|NCT02694692|"     The primary aim for this study is to determine if maternal Kangaroo Care (KC) provided during     painful procedures in early life will mitigate stress release and will improve     neurobehavioural outcomes in infants, decrease subsequent pain response, and enhance     maternal-child interaction beyond the period of hospitalization.   "
45153|NCT02694679|"     Social network targeting strategies can be used to improve the delivery and uptake of health     interventions. We will enroll approximately 30,000 individuals into a randomized controlled     trial of different targeting algorithms in order to explore how social network dynamics     affect the uptake, diffusion, and group-level normative reinforcement of key neonatal and     infant health behaviors and attitudes in 176 rural villages in the Copan region of Honduras.     Our goal is to develop methods by which global health practitioners can exploit face-to-face     social network interactions in order to maximize uptake of neonatal and infant health     interventions. The villages will be randomly assigned to 16 cells of 11 villages each in a 2     x 8 factorial design of different targeting algorithms.   "
45154|NCT02694666|"     This study is to investigate the effects of controlled whole-body vibration training on     reducing the likelihood of falls among healthy population and people with multiple sclerosis.   "
45155|NCT02694653|"     To evaluate the use of maternal opiates for pain control post cesarean delivery in those     patients that received intravenous acetaminophen 1000 mg in 150 mL of normal saline, infused     30 minutes prior to incision compared to placebo. A comparison of post delivery length of     stay in both study groups will be evaluated for cost effectiveness of the use of     acetaminophen. a secondary purpose is to determine the levels of neonatal acetaminophen in     cord blood at the time of delivery, since this has never been studied.   "
45156|NCT02694640|"     Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained     American Cancer Society volunteers to provide exercise counseling to breast cancer survivors     and the survivors increased their exercise in the short-term. This RCT examines the effects     of three maintenance conditions on survivors' exercise participation at longer follow-ups.     The cost-effectiveness of the three groups will be examined to guide implementation of this     peer mentoring approach in community-based organizations.   "
45157|NCT02694627|"     This study seeks to assess the impact of the MenCare+/Bandebereho fathers'/couples' group     education intervention on men's attitudes towards, and participation in, sexual and     reproductive health, maternal, newborn and child health, and equitable and non-violent     relationships with their children and partners.   "
45170|NCT02694458|"     Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric     therapy. The relationship between exposure to vancomycin and efficacy is admitted but because     of an important intersubject variability, therapeutic exposure isn't usually achieved.      The primary aim of this randomized controlled trial is to evaluate a new early dosage     adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy.      Using a bayesian approach, the purpose is to achieve earlier a therapeutic and non-toxic     exposure to vancomycin.      The primary hypothesis is that an early dosage adjustment strategy using a bayesian approach     will allow patients to achieve the vancomycin pharmacological target faster than with the     usual treatment strategy.   "
45158|NCT02694614|"     The purpose of this study is to evaluate the effectiveness and feasibility of weight loss     counselling via a smartphone-app for patients with overweight/obesity in a 1-year long pilot     study.      The study is organized in the following phases:      Recruitment (-14 to -2). Participants will be informed about the study. Participants agreed     to enter the study and signed an informed consent.      Screening / Baseline measurement (week -2) Inclusion criteria will be checked. Anthropometric     measurements: height, weight, waist circumference, body fat, blood pressure measurement,     blood sampling for blood glucose; HbA1c, Insulin; Triglyceride, HDL-Cholesterol (assessment     Part I). During the visit participants are requested to fill in a paper-pencil questionnaire:     socioeconomic background (only at the beginning of the study), dietary and exercise habits,     health-related quality of life, self-effectiveness (assessment part II). The participants are     introduced to the smartphone assisted coaching.      Introductory phase (2 weeks): Participants take pictures of their meals with the app, which     they send to the dietitian. After the introductory phase, the patients and the dietitians     discuss via app how the patients should change their habits and agree on goals to reduce     their weight.      Phase 1 (12 weeks): Intensive online counselling with the smartphone app, with the agreed     upon goals in mind (5 days per week + one Skype call). Group counselling session with /     without a dietitian are held if necessary. Furthermore, the dietitians make available     information material for patient specific dietary topics online. Week 12: assessment I+II.      Phase 2 (until week 25): The habits that further a weight reduction are being stabilised -     the frequency of the online counselling is reduced (3 days per week), group counselling with     / without a dietitian are held if necessary. Furthermore, the dietitians hand out information     material for patient specific dietary topics.      Phase 3 (week 26-52): This phase is relevant for maintaining the patient's wright. Online     counselling happens once every 2 weeks. Group counselling with / without a dietitian are held     if necessary. Furthermore, the dietitians hand out information material for patient specific     dietary topics. At the end end, the dietitians will again collect data (assessment I+II). The     online counselling process is evaluated with 3 group discussions.      Follow-up (week 104)   "
45159|NCT02694601|"     The aim of the study is to evaluate the effect of a caffeine supplement on the stimulation of     lipolysis and the production of ketones in healthy adults (N=10). Two different doses of     caffeine (2.5 mg/kg of BW and 5 mg/kg of BW) are compared. All the participants have to     follow three sequential visits of four hours each, which included a breakfast with one of the     doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and     repeated blood sampling in order to evaluate ketone concentrations.   "
45160|NCT02694588|"     Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated     barrier diseases with shared inflammatory pathways. Current therapeutic interventions with     anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways     of inflammatory immunopathology. Individual responses to biological treatment can be thereby     be exploited in a systems biology approach that employs a targeted mechanism of action (MOA)     to decipher molecular signatures of therapeutic responses in the context of a distinct     disease entity. Using a translational approach to investigate clinical and molecular     phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking,     the investigators aim to trace common and unique signatures of drug- and therapy-specific     responses.      Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall     by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior     to and during specific therapies with biologicals. In parallel, mucosa samples will be     obtained to define molecular phenotypes during the course of therapy.   "
45229|NCT02693626|"     The primary objective of this proposed three-year (January 01, 2016 to December 31, 2018)     project is to assess whether a program of widely accessed mobile phone-based text message     interventions ('Happy Quit') will be effective at helping people in China who smoke, to quit.     Based on the efficacy of previous studies in smoking cessation, it is hypothesized that     'Happy Quit' will be an effective, feasible and affordable smoking cessation program in     China.   "
45161|NCT02694575|"     This is a cross-sectional observational study aiming to examine and compare the impact of     incretin based therapies i.e. dipeptidyl peptidase-4 (DPP4) inhibitors and glucagon-like     peptide-1 (GLP-1) analogues, on endothelial progenitor cells (EPCs) and its mobilising     factor, stromal derived factor-1 α (SDF-1 α), in patients with type 2 diabetes mellitus     (T2DM) who are well established on those treatments. EPCs provide vascular protection by     means of endothelial repair and neogenesis. This endothelial protective effect may     potentially benefit patients affected by micro or macrovascular complications arising from     vascular injury e.g. cardiovascular disease in T2DM. The study is of particular interest as a     small study has shown an increase in level of circulating EPC in patients treated with DPP-4     inhibitors, thought to be mediated via the up regulation of its mobilising factor SDF-1 α.   "
45162|NCT02694562|"     The purpose of this study is to determine safety and local tumor control of Embozene TANDEM     Microspheres (40um TANDEM) loaded with Irinotecan to treat metastatic colorectal carcinoma     (mCRC).   "
45163|NCT02694549|"     The purpose of this study is to assess the performance and safety of the CaveoVasc® System     for femoral vascular access and for prevention of bleeding from the femoral artery puncture     site.   "
45164|NCT02694536|"     This open-label, single-arm, multicenter trial is designed to evaluate the safety of     erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants     with locally advanced, unresectable, or metastatic pancreatic cancer.   "
45165|NCT02694523|"     This is a randomized double blind, double dummy, active comparator controlled, parallel     design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066     (risankizumab) compared to adalimumab to support registration for the treatment of moderate     to severe chronic plaque psoriasis in adult patients.   "
45166|NCT02694510|"     Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be     measured in preterm infants less than 32 weeks gestation before and 7 days after receiving     either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN)     solutions.   "
45167|NCT02694497|"     Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular     treatment to understand the transmission of anorectal CT infections.   "
45168|NCT02694484|"     Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent     Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a     healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors     are being clinical and laboratory screening to reduce the likelihood of pathogens     transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations     requested by the Agence national de sécurité du médicament et des produits de santé in the     context of clinical research. A sero-matching between donor and recipient CMV is requested.     This recommendation eliminates many potential donors to a recipient. To date, the frequency     detection level of CMV in stool in healthy volunteers with documented positive CMV serology     is not known. In addition, CMV transmission risk via the stool is not established. This study     aims to determine the detection frequency of CMV in healthy volunteers stool samples selected     as potential donors for a FMT and having a positive CMV serology documented   "
45174|NCT02694406|"     As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide     number of immature microvessels. These vessels are characterized by a lack of coverage by     pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth     Factor on both endothelial and epithelial cells of ovarian cystadenocarcinomas. These physio     pathogenic characteristics have been demonstrated to be in line with variations of MR     perfusion parameters.      Unlike many lesions that occur in other parts of the body, biopsy should not be performed in     adnexal masses that demonstrate no evidence of peritoneal disease because it may cause     spillage of cystic contents, potentially leading to iatrogenic up-staging of what may have     been a malignant tumor that was limited.   "
45175|NCT02694393|"     This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis     and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the     burden of Pseudomonas.   "
45176|NCT02694380|"     The goal of this study is to measure the effect of radiation therapy on the activity levels     of patients. This will be achieved by tracking their activity levels during a treatment     course of radiation therapy.   "
45230|NCT02693613|"     The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of     single dose of ASP1517 in healthy non-elderly adult male subjects when administered     concomitantly or in a time separated manner.   "
45177|NCT02694367|"     The present study is based on hypotheses that some as yet unknown genetic factors may result     in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new     information about the underlying genetic causes of RM in the Egyptian population and to     investigate the expression of ERK and p-ERK protein in human placenta and their corresponding     tissue, to assess the significance of MAPK signal pathway in progression of recurrent     miscarriage and PI3K-Akt Pathway.   "
45178|NCT02694354|"     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single     rising oral doses of BI 685509   "
45179|NCT02694341|"     The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage,     including haemorrhage associated with placenta previa by compressing the lower uterine     segment.   "
45180|NCT02694328|"     This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects     with schizophrenia.   "
45181|NCT02694315|"     Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical     Assessment prior to induction of labor as regards induction success.   "
45182|NCT02694302|"     A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its     efficacy, safety over conventional gait training.   "
45183|NCT02694289|"     Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are     admitted for HF, leads to reduced insulin requirements, as measured in units of insulin, with     no negative impact on patient safety.      This is a single center, prospective trial. Subjects will be randomized to initiate metformin     (starting dose 500mg orally once daily up to a maximum dose of 2,500mg daily) OR be placed on     insulin products for management of their type 2 diabetes mellitus.   "
45184|NCT02694276|"     The aim is to evaluate if internet- delivered CBT, based on behavioral activation and     exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will     include 30 patients with symptomatic AF despite optimal medical treatment in accordance with     current guidelines.   "
45185|NCT02694263|"     This study aims to determine if the addition of Canagliflozin (Invokana™) therapy to     monotherapy of metformin is more effective at achieving the double composite endpoint of a     reduction in HbA1c (≥ 0.3%) and weight loss (≥1kg) 3-4 weeks post-Ramadan. The study will     also include patients currently on dual therapy, specifically metformin plus a sulphonylurea,     pioglitazone or repaglinide to determine whether switching to metformin plus Canagliflozin     (Invokana™) is more effective at achieving the composite endpoint compared to those remaining     on previous dual therapy. There are a number of secondary outcomes including weight loss,     rates of hypoglycaemia, blood pressure and a number of biochemical endpoints.   "
45186|NCT02694250|"     This study is being conducted to assess the radiographic (x-rays and CT scans) and clinical     outcomes for the use of DTRAX Cervical Cage with DTRAX Bone Screw for the treatment of     degenerative disc disease at one disc level with accompanying radicular symptoms in the     cervical (neck) spine.   "
45187|NCT02694237|"     The aim of the study is determine which method of informed consent improves comprehension in     college educated patients in a private practice setting.   "
45188|NCT02694224|"     To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in     breast cancer patients based on the CTCAE v4 2010        1. To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first biopsy          as compared to the later one        2. To detect predictive factors among patients who reached pathological complete response          (pCR) as compared to those with no pCR        3. To evaluate the role of the addition of vismodegib in the pCR rate        4. To evaluate clinical responses by breast MRI and rates of breast conservative surgery          after neoadjuvant chemotherapy        5. To evaluate QOL with EORTC QLQ-C30 scale   "
45189|NCT02694211|"     The Stress prevention at work (SPA) project intends to evaluate the method named Productivity     Measurement and Enhancement System (ProMES) as a stress preventive approach among health care     employees.   "
45190|NCT02694198|"     Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester abortion.   "
45221|NCT02693730|"     The purpose of this research study is to improve the understanding of irritable bowel     syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance     imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared     to healthy controls and people with ulcerative colitis, a disease group that has already been     characterized. By doing this correlative and comparative study, the investigators hope to     gain knowledge on IBS in order to keep the field moving in the right direction and becoming     one step closer to discovering effective treatments.   "
45222|NCT02693717|"     The goal of this clinical research study is to learn if Altima (pemetrexed) can help to     control urothelial cancer (bladder, urethra, and/or ureters) that has spread or cannot be     controlled with surgery. The safety of this drug will also be studied. Researchers will also     study how a gene called MTAP may affect the way the study drug works.   "
45191|NCT02694185|"     Ischemic heart disease (IHD) and its treatment carry profound public health and economic     implications. Among Veterans, IHD represents one of the most common causes of death and     disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far     less common than IHD can affect multiple organ systems and requires therapies costing in     excess of $50,000 a year. Optimal treatment of Veterans with IHD and rheumatic disease     requires a number of medications to maintain or improve health. Not taking medications as     prescribed, however, is common and increases the risk of subsequent adverse events (cardiac     death and myocardial infarction [MI]).      To improve medication adherence rates and the cardiac health of Veterans with IHD, the     investigators propose to test a medication adherence intervention. Known as VA SEPPRMACI-ARM     (Secondary Event Prevention using Population Risk Management After PCI and for Anti-Rheumatic     Medications), this intervention will consist of: proactive real-time adherence monitoring of     patients and targeting of individuals if they have not refilled their medication a given     number of days after it was due for refill. The intervention will employ a tailored,     escalating-intensity approach which begins with some combination of personalized short     messaging service (SMS) text messages and interactive voice response (IVR) telephone     technology, depending on patient preference. Patients not completing SMS and then IVR by not     refilling their medication (or declining SMS and not completing IVR) escalate to a trained     research interventionalist. The interventionalist will contact the patient and address     adherence barriers based on the dimensions outlined by the World Health Organization (WHO)     that are specific to each patient. The investigators will test the intervention on IHD     patients who have recently undergone PCI-a cardiac procedure commonly used among IHD patients     to improve the heart's blood flow and in patients starting anti-rheumatic medication. The     investigators will test the intervention at four VA Cardiac Catheterization Laboratories     (CCLs) and have 12 sites serving as usual care controls.   "
45192|NCT02694172|"     The main objective of the clinical trial is to investigate whether overweight type 2 diabetic     patients have a different fecal microbiota profile compared with age, gender, BMI matched     subjects and with lean healthy subjects before and after the consumption of fiber rich cereal     bars.   "
45193|NCT02694159|"     The study goal is to improve the value of care and reduce health disparities by developing a     targeted set of sophisticated and powerful algorithms to improve upon human clinical     judgments. The plan is to use the test case of detecting sepsis in patients in the emergency     department (ED) as the first step in improving the value of care and reducing health     disparities by developing a targeted set of sophisticated and powerful algorithms to improve     upon human clinical judgments. This work will be performed using data from the University of     Pennsylvania Health System where a preliminary Early Warning and Response System for Sepsis     monitors clinical parameters. The premise underlying all this work is that by improving     decision-making, it will both reduce low-value care and health disparities.   "
45195|NCT02694133|"     The study will invite 30 patients to join, and they will be arranged in the face to face     group and telerehabilitation group randomly.      In the telerehabilitation group, the investigators use the mobile device, which with the     camera and speaker, for patients to practice the naming training at home, and assess the     speech ability every 2-4weeks by speech therapist via telerehabilitation platform.      Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as     the assessment tool for evaluation speech ability and functional ability.      The investigators expect that patients can improve their speech ability, functional ability,     and quality of life via telerehabilitation speech therapy.      And the investigators can establish the standard telerehabilitation speech therapy protocol     for aphasia therapy.   "
45196|NCT02694120|"     Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer,     through the recognition and removal of pre-cancerous lesions, which in most cases evolve with     a sequence that goes through formation of high-grade dysplasia (HGD).      The probability of HGD increases with the increase of the lesion of the polyp itself.     Lesions> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions     presents a greater technical difficulty and consequently a decrease in the efficiency. The     rate of incomplete resection reported in the literature reaches 10% while that of recurrence     / residual adenoma 16.4 / 31.7%.      The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost     of endoscopic resection of colic lesions> 2cm in a setting of clinical practice in an     unselected population   "
45197|NCT02694107|"     The purpose of the present study was to measure the effect of proprioceptive training,     short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up.      Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which     would perform proprioceptive exercise, or the control group(n=19, no intervention) .   "
45198|NCT02694094|"     This research is being done to evaluate the short term and long term effects of ketogenic     diets on measures of cardiovascular health. Such measures include cholesterol levels, blood     pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older     who are already on a ketogenic diet for at least 12 months or who are interested in beginning     on the modified Atkins diet may join.   "
45199|NCT02694081|"     The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II     Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.   "
45200|NCT02694068|"     Peritoneal Dialysis (PD) is a technique for treating kidney failure where fluid is instilled     into the body's peritoneal cavity. Fluid and solutes travel across the peritoneal membrane,     and the function of this membrane is critical to successful PD. Studies have shown that     certain demographic and clinical variables explain a very small part of the variability in     baseline function. This study will further explore the common genetic variants that determine     the baseline peritoneal membrane function in patients starting treatment with PD and change     in function upon treatment .      This study will incorporate data from subjects' first ever peritoneal equilibrium test (PET),     changes in the transfer of water across the peritoneal membrane over time, demographic     information, and results from laboratory analysis of DNA, blood, and dialysate. The     investigators hope that this study will provide information on the biological pathways that     account for variability in the peritoneal membrane. This could ultimately lead to the     development of biomarkers to identifying individuals at risk for decline in peritoneal     membrane function over time and/or be used to identify novel therapeutic targets to preserve     or enhance membrane function. Identifying the biological pathways will also increase the     understanding of vascular biology, angiogenesis, and fibrosis that could be applied to other     tissues and other diseases.   "
45223|NCT02693704|"     This study investigates the possible benefits of using binaural spatialization techniques in     digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker     localization tests and preference tests are performed. The results of a diotic (current     rendering) and a binaural (suggested rendering) rendering are compared.   "
45224|NCT02693691|"     The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used     in a real-world setting.   "
45201|NCT02694055|"     The purpose of this study is to evaluate whether the addition of Proactive Case Detection to     Community Case Management will provide an increase in early access to health care and a     reduction in deaths among children aged 0-59 months. Integrated Community Case Management is     the package of community-based services for children delivered by Community Health Workers     (CHW), including diagnosis and treatment of malaria, pneumonia, diarrheal disease and     malnutrition. In many i-CCM interventions, CHWs are stationed in their villages and available     in a passive, reactive manner to provide care to patients who seek them out. This study seeks     to determine whether the addition of proactive case detection by CHWs, in which the conduct     daily door-to-door home visits to find and care for patients, improve early access to care     and reduce child mortality.      Villages will be randomised to receive Integrated Community Case Management (i-CCM) from a     passive CHW or Proactive Community Case Management (Pro-CCM) from a CHW that conducts daily     active case finding home visits. All villages in both study arms will receive additional     interventions that could significantly reduce under-five mortality, including removal of     point-of-care fees, clinical staff training at primary health centres, and improvement in     health centre infrastructure.      All women of reproductive age eligible for inclusion in the study will be surveyed at     baseline, and again at 12, 24 and 36 months. The study hypothesis is a significant reduction     in child mortality in both study arms, with a significantly larger reduction where there is     proactive case detection, or Pro-CCM, by CHWs. An exhaustive survey of 22 847 women of     reproductive age followed for three years will give a study which has 90% power to detect an     absolute difference of 0.75% (and a relative difference of 25%) in under-five child mortality     reduction between the two study arms.   "
45202|NCT02694042|"     Crohn's disease and ulcerative colitis, known together as inflammatory bowel disease (IBD),     are chronic inflammatory conditions of the gastrointestinal tract. Impacts of IBD such as     frequent hospital visits, need for surgery and poor growth, can significantly impact a     child's social and academic life. Dealing with a chronic disease forces children to rely more     heavily on family members for coping strategies to deal with stress. However, a lot of     families do not have the resources (emotional or financial) to provide the level of support     needed. A self management site called Mission is Remission® has been created to help     adolescents and their families deal with the stressors associated with their disease. The     site provides a supportive social network that is centred around learning sessions and active     forums discussing topics related to disease self-management and coping. This site actively     brings together members of the healthcare team and provides support to families who might not     be able to travel for additional appointments outside of routine care. The goal of our     research is to understand whether the changes this social support will increase     disease-specific knowledge, medication adherence, and health-related quality of life. We will     also examine whether these changes may reduce some of the demands placed on the Health Care     system (e.g., reduced number of calls and visits to gastroenterology (GI) doctors, or time     lost from school/work). In addition, this website has been designed to be adapted in the     future to other chronic diseases and will help bring healthcare into the digital age.   "
45203|NCT02694029|"     Female patients treated with radiation for left-sided breast malignancy will undergo     alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep     Inspiration Breath-Hold (DIBH).   "
45204|NCT02694016|"     The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective     effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing     isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological     evaluation preoperatively and at 30d after surgery will establish if there are any     differences in neuropsychological performance between groups. A large array of biochemical     markers will be analyzed from plasma samples taken at different time points. Additionally     skin biopsies from the lower limb will be taken before and after performing RIPC on said     limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical     markers from plasma and tissue samples will be used to asses brain tissue damage,     inflammation and cardiac tissue damage between groups.      This will be a single center prospective randomized study with two groups. A intervention     group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per group.   "
45205|NCT02694003|"     More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems,     whereas less than 25% of typically developing children experience sleep problems. Poor sleep     can have significant consequences for children's physical and psychosocial health, as well     their caregivers' well-being. The impact of sleep problems on daytime functioning is even     greater in children with NDD. Although there are a range of factors that may disturb sleep in     children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia.     There is some evidence that behavioural interventions can be effective in improving sleep in     children with NDD. However, this has not been tested through well-designed, large-scale     randomized controlled trials (RCTs). Moreover, there are a number of significant barriers to     access for insomnia treatment for children; most importantly, sleep interventions are often     only provided by specialists, limiting access to treatment services. Instead, behavioural     insomnia is often treated with advice about sleep hygiene and with the supplement melatonin,     which is, at best, a short-term solution. The investigators, an interdisciplinary team of     researchers, will develop and evaluate the effectiveness of an online sleep intervention that     will be widely accessible and sustainable and will have the potential to dramatically improve     the health of children with NDD and their families.   "
45206|NCT02693990|"     This research study is studying radiation therapy as a possible treatment for meningioma or     tumor on the lining of the brain. The study drug or intervention involved in this research     study is Intensity Modulated Proton Therapy (IMPT)   "
45218|NCT02693834|"     PURPOSE: The purpose of this study will be to identify whether patients in the subacute stage     of stroke, who demonstrate foot drop, will have better gait outcomes when using a Double     Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to determine     whether one week of practice significantly changes gait outcomes with either of the AFO     conditions.      INCLUSION CRITERIA: Twenty participants over the age of 18, of any gender and ethnicity,     diagnosed with first time unilateral stroke, 4 - 20 weeks post-stroke onset, resulting in     hemiparesis with foot drop will be recruited for this study.      EXCLUSION CRITERIA:        1. Not able to receive a double adjustable AFO through their insurance        2. Unable to follow two steps commands        3. Unable to ambulate 20 feet with or without assistive device with a minimum level of          assistance of contact guard assistance.        4. Cerebellar Stroke        5. Inability to ambulate prior to stroke      OUTCOME MEASURES:        1. Six Minute walk test        2. Gait Symmetry and Gait velocity measured with GAITRite for self paced velocity walk and          fast paced velocity walk.      DATA COLLECTION:      Data will be collected three times over two weeks period.      First Visit:      Demographics, Fugl-Meyer Lower Extremity Assessment of sensorimotor function, Mini Mental     State Examination 6MWT and GAITRite measurements using Both types of AFO in a random order.     Afterwards participant will be given one type of AFO (randomly selected) to practice walking     for a week.      Second Visit: 6MWT and GAITRite measurements using the type of AFO they were practicing with.     Then the other type of AFO will be given to practice walking for a week.      Third Visit: 6MWT and GAITRite measurements using the second type of AFO that they were     practicing with the week prior. Patient will be asked which type of AFO they prefer to use.   "
45219|NCT02693821|"     The study's objective will be to evaluate the gabapentine efficiency in orally and long term     used after painfully surgeries.   "
45207|NCT02693977|"     Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in     breathing during sleep. It affects at least 1-3% of the general pediatric population with     greater prevalence among certain high risk groups such as children with obesity, Down     syndrome, craniofacial anomalies, or neuromuscular disorders. Several studies have shown     that, even after having adenotonsillectomy (AT), approximately 30% of children continue to     struggle with OSA. They further found that older children (age > 7 yrs), obesity, and high     pre-operative OSA severity were all risk factors contributing to residual OSA. Despite these     known risk factors, the ability to predict each individual patient's risk of residual OSA     after tonsil surgery is difficult. Determining what tool will best predict residual OSA is an     important step towards more effective post-surgery OSA management.      The purpose of this study is to determine whether sleep endoscopy can predict whether their     AT will be successful as a treatment for OSA. Our hypothesis is that subjects with multiple     areas of obstruction in addition to large tonsils will be more likely to have residual OSA     after AT. Sleep endoscopy is a procedure performed during drug-induced sleep that involves     passing a flexible endoscope through the subject's nose into the back of the throat to look     for sources of obstruction while breathing spontaneously.      This will be a prospective cohort study examining subjects between the ages of 2 and 18 who     are having AT for treatment of obstructive sleep apnea (OSA) and are considered high risk for     residual OSA after surgery. High risk will be defined based on the following criteria:     obesity, Down syndrome, African American race, severe baseline OSA, and age > 7 yrs. Eligible     subjects will be recruited from the pediatric otolaryngology clinic at the time of initial     evaluation for AT. Subjects will undergo a sleep endoscopy under moderate sedation at the     time of AT. All patients will be asked to complete a preoperative sleep study to confirm the     diagnosis of OSA and a postoperative sleep study to determine the impact of AT and the     presence of residual OSA. Secondary outcome measures will include several questionnaires     assessing generic and OSA-specific quality of life as well as subjective measures of     cognitive/executive functioning and daytime sleepiness.   "
45208|NCT02693964|"     The study is aimed to evaluate the differences in bone mineral density (BMD) and Carotid     Intima Media Thickness (CIMT) between postmenopausal women with type 1 diabetes (T1D)     compared to postmenopausal women without diabetes.   "
45209|NCT02693951|"     The purpose of the study is to assess the efficiency and safety of prophylactic use of     antibiotics in endoscopic injection of tissue adhesive in gastric varices.   "
45210|NCT02693938|"     This research study is designed to look at differences in responsiveness to the subcutaneous     injection of a standardized dose of rapid-acting insulin analog and blood glucose variability     during different phases of the menstrual cycle in females with type 1 diabetes (T1D).   "
45211|NCT02693925|"     The purpose of this study is to determine the prevalence of sleep-related breathing disorders     (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of     polygraphy.      Furthermore, the practicability of the underlying diagnostic process in clinical application     is assessed as well as the sensitivity and specificity of polygraphy as compared to the     reference standard of polysomnography. Another aim is to determine the individual     cardiovascular risk profile by pulse wave analysis and risk classification according to     European Society of Hypertension (ESH) and European Society of Cardiology (ESC), ESH/ESC     risk.   "
45212|NCT02693912|"     In this study, the investigators aim to observe the change in alveolar macrophage function     during acute lung injury.   "
45213|NCT02693899|"     Despite advances in their classification and treatment, acute leukemia remain incurable     disease for the majority of patients. It is necessary to identify new prognostic markers of     survival and new therapeutic targets to improve prognosis. Some studies have shown that     Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent     study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an     increase of this marker in the blood of patients responding to treatment. The aim of our     prospective, non-interventional study is to measure the plasma levels of FLT3-L at different     times of the management of patients with acute lymphoblastic leukemia but also myeloid. For     this, analyzes of the samples collected in the usual care will be conducted to study the     relationship between the plasma concentration of FLT3-L and outcomes. If there is any link,     the FLT3-L could serve as a predictor of treatment response.   "
45214|NCT02693886|"     Individualized colonoscopy withdrawal time is determined based on the different grade of     physician experience and quality of bowel preparation.   "
45215|NCT02693873|"     Osteoarthritis (OA) most often affects the hip and knee joints. The first signs and symptoms     of pain, stiffness or swelling are not uncommon in those in their thirties and forties and 10     per cent report symptomatic knee OA by age 60 years. Education and exercise are essential for     people with OA to help them manage their condition better. Exercise can reduce pain, improve     mobility and enhance quality of life. However, doing the right exercises in the right way is     important so that joints are not overly stressed.      The purpose of this study is to evaluate an existing evidence-based program called, Good Life     with osteoArthritis in Denmark (GLA:D). The program has been translated and adapted to the     Canadian context and will now be implemented in a Canadian therapy setting to start to     understand if it is effective. This is the first time this program is being tested in Canada.      While some people have access to self-management programs for OA, these programs often     provide only general exercise guidance and education. GLA:D integrates patient education and     targeted, personalized exercise for people with hip and/or knee OA. Importantly, the     exercises are taught so that individuals learn to incorporate them in their everyday     activities. This research is the first step to understanding if people participating in this     program have pain relief and improved function and if they are better able to manage their     hip or knee OA symptoms. Additionally, this initial evaluation of the program will help     create a better understanding of the challenges in delivering the program. This will be     valuable information for offering future programs assuming success of this pilot study.      It is anticipated that about 60 people (30 hip OA and 30 knee OA) will participate in this     study. These people will be recruited from the Sunnybrook Holland Orthopaedic and Arthritic     Centre in Toronto, Ontario, Canada. All consenting participants will receive the GLA:D Canada     program delivered by Sunnybrook's therapists.   "
45216|NCT02693860|"     10 patients will be enrolled in the initial cohort and will receive two infusions of     unlabeled huJ591 on days 1 and 14. 89Zr-J591 will be administered on day 21 (+ 1 day) and a     positron emission tomography-computed tomography (PET/CT) will be performed week later on day     28 + 1 (visit 4). Approximately 2 to 3 weeks after the 2nd dose of J591, the patient will     undergo radical prostatectomy with or without lymph node dissection (day 31 + 4 days). The     final visit for the study will include a postoperative visit two weeks following surgery.   "
45217|NCT02693847|"     Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia,     southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV     infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a     liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver     disease. Patients are prospectively followed-up according to a uniform protocol of care.     Epidemiological, clinical and laboratory variables are periodically recorded. The primary     outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma),     liver transplant or death. The predictors of these outcomes are analyzed.   "
45220|NCT02693808|"     The purpose of this study is to determine whether injection of autologous fat or     hyaluronic-acid injections in temporal region are effective in the treatment of temporal     hollowing after lateral wall decompression in patients with thyroid eye disease.   "
45231|NCT02693600|"     1. Introduction:           Investigators think that surgery with preservation of healthy joints (hemitrapeziectomy)          in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints,          is better for scaphoid stability by preventing its collapse and thus preserving the          stability of the carpus.        2. Objectives and Hypothesis:           Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better          results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with          total trapeziectomy.           Main Objective:           To demonstrate using the dynamometer that the postoperative key pinch strength higher          using ligamentoplasty with partial trapeziectomy in grades II-III Eaton.           Secondary objectives:           To measure the collapse of the first column of thumb using calibrated radiographic          analysis. Pain (E.V.A Scale). Range of motion (measured with goniometer). Quality of          life (DISABILITIES OF THE ARM, SHOULDER AND HAND questionnaire).        3. Methodology:      It is a single-center randomized trial, parallel-group, in which two types of surgical     techniques (TT - TP) will be compared. Patients will be randomized in this two techniques     will be followed for one year, in routine clinical practice.   "
45232|NCT02693587|"     In Denmark, every 4 birth induced, most often due to prolonged pregnancy, up til 10-12 days     after term. A group (RADS) set up by the Danish Regions has recently recommended induction     with prostaglandins in tablet form (Angusta®). The recommendation is based primarily on the     results of a meta-analysis published by the Cochrane Library, where various prostaglandin     medications were compared.      Vaginal prostaglandin insert (Misodel®) have proved safe in American Studies and is     registered in Denmark for use of induction. Misodel® was not included in RADS's evaluation,     as there are only few studies on the effectiveness and side effects.      In the current study, investigators want to compare two different regimes for the induction     of primipara who use respectively Misodel® and Angusta® as the primary method. The study is     based on prospective collection of data from three divisions in Region Zealand, where     investigators primarily compare the efficacy and safety but also to evaluate women's     experience, the cost of medicine and consumption of resources in the maternity wards.   "
45233|NCT02693574|"     Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the     Eradication of Helicobacter Pylori in Syrian population   "
45234|NCT02693561|"     Smoking is an important public health issue. The self help books may have important     motivational implications which associated with deep breath exercises could cease the habit.     Goals: Verify the effectiveness of the deep breaths exercises from the self help books along     with the two motivational interventions to quit smoking on the anxiety, depression and daily     consumption levels. Method: The study will be both prospective and controlled. Individuals     will be distributed randomly in 4 different groups: The first group will be doing the deep     breath exercises, the second group will read a self help book, the third group will do both     reading and exercises and the fourth group will be the control. Anxiety, depression,     motivational level and the cigarettes daily consumption will be evaluated previously and     after the 15 days intervention. Expected results: Decreasing in anxiety, depression and     cigarette consumption plus an increase in the motivation to quit smoking.   "
45235|NCT02693548|"     SAFEHEART is a large, on-going registry study in molecularly defined patients with     heterozygous FH treated in Spain.   "
45236|NCT02693535|"     The purpose of the study is to learn from the real world practice of prescribing targeted     therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be     a drug target or to predict sensitivity to a drug.      NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant     biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest     participating TAPUR site (see participating centers).   "
45237|NCT02693522|"     The purpose of this study is to evaluate the efficacy and safety of recombinant human growth     hormone on adult growth hormone deficiency   "
45238|NCT02693509|"     Get With The Guidelines-Heart Failure is designed to improve the quality of care in patients     hospitalized with heart failure. The program aims to help ensure that eligible patients are     initiated on guideline recommended therapies and receive appropriate counseling prior to     hospital discharge.   "
45239|NCT02693496|"     Patients with lung nodules may develop a variety of potentially severe symptoms. These     symptoms may impact a patient's quality of life and lead to difficult treatment. Through this     research program, the investigators want to understand the pathogenesis of the changes of     these symptoms.   "
45240|NCT02693483|"     Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean     endometritis.   "
45241|NCT02693470|"     Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic     vascular diseases, including stroke, myocardial infarction, and impaired microcirculations,     among which circulating microparticles play an important role. In severe psoriasis, there are     increased endothelial- and platelet- microparticles that are reduced by TNF-α blockers in     parallel with clinical improvement. However, whether Stelara(ustekinumab) treatment would     decrease the level of microparticles remains unknown.      Objective: The investigators will evaluate the level of microparticles among normal control,     severe psoriasis before and 4 months after ustekinumab treatment.   "
45242|NCT02693457|"     This randomized controlled trial is designed to determine the effect of suction drain usage     on the reduction of postoperative swelling following total knee replacement. Furthermore,     this study will determine the relationship between postoperative swelling and quadriceps     muscle function. This study will be performed in a cohort of patients undergoing bilateral     total knee replacement and the suction intra-articular drain will be randomized to one of the     two operative knees prior to surgery.   "
45281|NCT02692950|"     Rates of advance directive completion among Americans, even those suffering from serious     chronic illness, are notoriously poor. Moreover, the contents of completed advance directives     are often difficult to interpret in the face of a medical crisis. The study aims to examine     patient perceptions of electronic, interactive versions of advance care planning     documentation.   "
45282|NCT02692937|"     The purpose of this study is to compare the effects of neurolysis with the effects of a     exercise program on pain and other symptoms in individuals with chronic whiplash (WAD     II-III).   "
45243|NCT02693444|"     Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness.     The level of pain is often a limiting factor when assessing shoulder range of motion and     strength pre-operatively. Pain itself has even been a cause of weakness due to muscle     atrophy.      The purpose of this study is to further understand the effect pain has by measuring constant     shoulder scores in patients before and after ultrasound guided subacromial (the outer end of     the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to     saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The     saline and lidocaine has been approved for use by the U.S. Food and Drug Administration     (FDA). The constant shoulder score includes your level of pain, activity level, range of     motion and strength measures.   "
45244|NCT02693431|"     Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic     treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them     and those around them, stressful, rarely expressed, but noticeable by the care team. In line     with the recommendations of the High Authority of Health, the multidisciplinary team of     Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University     Hospital offers a therapeutic education program tailored to the needs of children with cystic     fibrosis and their families . The aim is to support children and parents in the acquisition     of self-care skills (knowledge and skills) and coping skills, such as managing stress and     emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the     child, facilitates its expressive capabilities and reduces anxiety.   "
45245|NCT02693418|"     The objective of this study is to determine the magnitude and duration of the reduction in pH     (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g     compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH will be     measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants will     be assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel     (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).   "
45246|NCT02693405|"     Significant advances in primary malignant brain tumors (PBT) treatment have led to     dramatically improved survival, both in children and adults. However, survival has not come     without a cost and aggressive treatment methods associated with significant long-term adverse     effects, often referred to as late effects (Panigrahy & Blüml, 2009). These effects are the     medical, physical, cognitive and psychosocial sequelae associated with cancer and its     treatments that generally emerge two to five years after treatment ends (e.g., Landier &     Bhatia, 2008).      The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One     especially important cognitive domain is executive functioning, which refers to essential     factors such as problem-solving, goal-directed behavior and the ability to maintain stable     interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive     impairments on behavioral regulation and quality of life, few studies were conducted with     survivors of PBT specifically for the assessment of executive functioning. Another     fundamental neuro-cognitive domain is social cognition, which refers to the ability to     understand the intentions and beliefs of others (Frith & Singer, 2008). Social cognitive     deficits are expected to impair autonomy and relationships, but scarce attention has been     devoted to the study of social cognition in survivors of PBT and no study has attempted to     compare socio-cognitive data and measures of health-related quality of life. It is noteworthy     that executive function and socio-cognitive skills improve throughout childhood and     adolescence, and improvements in these skills have frequently been attributed to maturation     of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a     greater impact of the disease and its treatment on these functions in children/adolescents.   "
45247|NCT02693392|"     In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing     therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be     evaluated using standard methodology.   "
45248|NCT02693379|"     The purpose of this study is to determine whether smartphone photos may assist health-care     worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical     examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with     conventional VIA, for human papillomavirus (HPV) positive women.   "
45249|NCT02693366|"     The purpose of this study is to analyze the safety, renal function, metabolic disorders and     quality of life data in patients with focal segmental glomerulosclerosis treated with     endovascular infusion of bone marrow derived mononuclear cells.   "
45250|NCT02693353|"     Prospective, observational cohort study evaluating the association between pre-surgical     existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular     edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.   "
45251|NCT02693340|"     This is a monocentric prospective study for the collection of biological samples (blood and     biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers     of response to biological treatments in inflammatory bowel disease (IBD).   "
45252|NCT02693327|"     This research study will examine the relationship interconnecting medical body health, mental     health, and microbes of the digestive tract in persons living with serious mental     illnesses,as compared to persons without such disorders. Existing research suggests that     interactions between digestive tract microbes and the body may influence brain function     circuits, mood, anxiety state, cognition, behavior, and medical physiology.   "
45253|NCT02693314|"     The purpose of this study is to determine the effects of the two doses of Jarro-Dophilus EPS®     probiotic supplements on fecal lactobacillus and bifidobacteria numbers, transit survival of     administered probiotic strains, fecal microbiota, gastrointestinal function and general     wellbeing in healthy human adults.   "
45254|NCT02693301|"     This study aims to analyze the effects of an exercise program in the pulmonary function,     cardiorespiratory fitness, diet quality index, physical activity, body composition, muscle     function, agility, and psychological health in a group of children with asthma and     respiratory symptoms.   "
45288|NCT02692859|"     Haemophilus influenza type b (Hib) remains a serious global health threat associated with     high mortality and morbidity in young children. In China, The overall impact of Hib-related     infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally,     vaccination has been considered the most effective way to prevent infection against Hib.In     order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib)     conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical     trial is planned to conduct in healthy infants and children in China.   "
45315|NCT02692508|"     The investigators sought to evaluate the morphological and functional changes and prognosis     of participants with unexplainable precordial deep T-wave inversion on ECG and with apical     thickness less than 15mm. The conduction of this study was largely due to the increased     clinical requirement, which reflected the increased awareness among physicians of missed     AHCM.   "
45255|NCT02693288|"     Distal radial fracture reparations by volar plating are often managed under regional     anaesthesia, but are associated with severe pain when the block ends. Acute post-operative     pain may delay rehabilitation, and even be a risk factor for the development of chronic pain.     The use of opioids and the inevitable opioid-related side effects further decrease patient     satisfaction. A multimodal approach to pain management should include local or regional     analgesia technique when possible. In the case of wrist fractures, two methods are available:     peripheral nerve block by the anaesthesiologist or surgical site local infiltration by the     surgeon with a long-acting local aesthetic. Both techniques are commonly used for the     management of postoperative pain after diverse orthopaedic surgeries.      The purpose of this study was to determine the equivalence between ultrasound-guided     peripheral nerve block and local infiltration by the surgeon for short-term postoperative     analgesia after surgical reparation of isolated closed wrist fractures by volar plating under     regional anaesthesia. The quality of postoperative pain, patient satisfaction and adverse     events were recorded for the first 48 hours following surgery.   "
45256|NCT02693275|"     This study is being conducted to create a database for the Quotient® System iPad Test. Using     community sampling, NCS Pearson will compile the results of this study to create a database     against which the results of clinical Quotient tests may be compared to determine patient     performance relative to the expected results for developmental age and gender.   "
45257|NCT02693262|"     Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about     how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient     cardiovascular health and quality of life. Patients are being asked to participate in this     study if they have a history of heart failure and have or are scheduled to be implanted with     a BIOTRONIK ICD that is capable of closed loop stimulation (CLS). CLS is a device setting     that works with the cardiovascular system to optimize their heart rate during physical     activity. This study is comparing BIOTRONIK's CLS setting to a standard accelerometer     setting, which also is able to adjust the heart rate by movement sensors, when necessary.     This study has been initiated by Dr. Hsu and Dr. Adler and is financially supported by     BIOTRONIK, Inc. There will be approximately 15 participants in this trial.   "
45258|NCT02693249|"     The purpose of this study is to investigate the psychological consequences of motor vehicle     accidents and burn accidents in 7-18 years old children and adolescents. The impact of     posttraumatic cognitions on developing psychological symptoms are of particular interest.   "
45259|NCT02693236|"     The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic     cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced     esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin     that transfected DC, which are used for DC-based immunotherapy. Based on the results of our     previously performed preclinical study with DC vaccine combined with CIK cells, the     researcher plan to perform the clinical trial.   "
45260|NCT02693223|"     Get With The Guidelines-Stroke is a program for improving the quality of care for patients     hospitalized with stroke by promoting consistent adherence to the latest evidence-based     clinical practice guidelines.   "
45261|NCT02693210|"     WA16291 is a Phase IIa proof-of-concept study. The primary objective of this study is to     determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal     antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide     in participants with rheumatoid arthritis who have failed prior Disease Modifying     Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to     methotrexate.   "
45262|NCT02693197|"     The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and     T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment     compared to matched healthy control subjects.      The secondary objective is to determine the safety and tolerability of single-dose T -817MA     (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.   "
45263|NCT02693184|"     The purpose of this study is to validate a revised food frequency questionnaire that is     designed to capture vitamin D, calcium and protein intake in a population of elderly men and     women with fragility fractures. Protein, calcium and protein intake will be correlated with     biochemical measures and bone mineral density measured by DXA.   "
45264|NCT02693171|"     The purpose of this study is to assess the incidence of human anti-chimeric antibody (HACA)     in high-risk neuroblastoma patients treated with Unituxin combination therapy.   "
45265|NCT02693158|"     The primary objective of this multicenter, single-arm, observational study is to evaluate the     feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS     Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an     all-comers, real-world population.   "
45266|NCT02693145|"     CoRECT will help identify the important components of a data-sharing partnership between     health departments and HIV care providers, and determine the extent to which a health     department intervention can increase the number of HIV-infected persons out-of-care who: (a)     link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load suppression     within 12 months; and (d) achieve durable HIV viral load suppression over 18 months. We will     also measure the cost-effectiveness of this intervention in regards to improved health in the     individuals (re)-engaged in HIV care and reductions in further HIV transmission in the     community.   "
45296|NCT02692755|"     This study aims to evaluate the hematological safety of palbociclib with letrozole in African     American women with hormone receptor positive HER2 negative advanced breast cancer.     Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment     discontinuation due to neutropenia according to current recommendations for management of     neutropenia   "
45297|NCT02692742|"     Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting     the doses and density of chemotherapy that can be tolerated. The degree and duration of     neutropenia determine the risk of infection. Myelo001, a small orally bioavailable molecule,     has been shown in chemotherapy- or radiotherapy-induced myelosuppression to stimulate     differentiation of peripheral white blood cells (WBC) and bone marrow cells of the     leucocytic, lymphocytic, and erythrocytic lineage. The purpose of the MyeloConcept study is     to determine the safety and effectiveness of Myelo001 in preventing or reducing     chemotherapy-induced neutropenia and myelosuppression in patients receiving chemotherapy due     to breast cancer.   "
45267|NCT02693132|"     Adults who are overweight or obese are typically prescribed a calorie-restricted diet and     physical activity to promote weight loss and improve health. The manner in which physical     activity is prescribed and monitored may influence physical activity engagement. Within the     context of clinical research, physical activity has been prescribed in either a supervised or     unsupervised manner. Supervised physical activity is typically done in a health-fitness     facility under the direct supervision of trained staff. The alternative, unsupervised     physical activity, promotes physical activity participation in a setting that is convenient     to the individual. Unsupervised activity can be done in any environment or at any time that     best suits the individual. Knowing the effects of unsupervised physical activity is important     because of the translation of this type of physical activity to non-research settings.     Therefore, knowing the magnitude of the physiological effects of unsupervised physical     activity compared to supervised physical activity at the same prescribed intensity and dose     is of clinical and public health importance. This study is designed to provide insight on     these important research questions that can inform future research and the application to     clinical, public health, and health-fitness settings.   "
45268|NCT02693119|"     This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center     study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy of     elamipretide (MTP-131) topical ophthalmic solution in this patient population. At the     conclusion of 52 weeks of treatment, subjects will be offered the opportunity to enter an     Open Label Extension for up to 48 additional weeks of treatment.   "
45269|NCT02693106|"     The aim of this study is to evaluate the capacity of different dietary supplements to     increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate,     carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which     multiple blood samples are taken in order to measure ketone production.   "
45271|NCT02693080|"     This pilot clinical trial studies computed tomography (CT) perfusion imaging in predicting     treatment response in patients with non-small cell lung cancer or tumors that have spread     from the primary site (place where it started) to the lungs (metastases) treated with     stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that     uses an injected dye in order to see how blood flow through tissues, including lung tissue.     CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of     lung tumors may be predictive of response to treatment and whether lung perfusion     characteristics can be used to follow response to treatment.   "
45272|NCT02693067|"     This study is intended to determine the safety, tolerability and reduction of biochemical     markers (Chromogranin A or, if deemed appropriate, 5-hydroxyindoleaceticacid) and troublesome     symptoms (particularly diarrhea and flushing) of intralesional injection of PV-10 in subjects     with NET metastatic to the liver that are not amenable to resection or other potentially     curative therapy.   "
45273|NCT02693054|"     Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.   "
45274|NCT02693041|"     Investigators hypothesize that        1. intake of milk products containing probiotics are associated with a reduced risk of          spontaneous preterm delivery.        2. intake of milk products containing probiotics are associated with a reduced risk of          preeclampsia.        3. probiotics decrease the overall inflammatory state in the pregnant woman.   "
45275|NCT02693028|"     Investigators want to investigate if the Lactobacillus Reuteri (probiotic bacteria) given to     pregnant women can be found in different maternal compartments and in the first stool and     oral swab collected immediately after birth of a newborn delivered by cesarean delivery.     Investigators also want to explore if exposure to this Lactobacillus Reuteri alters the level     of inflammation in different compartments of the mother and the infant.   "
45276|NCT02693015|"     This study aims to investigate the extent to which the time to angiography impacts on     survival in patients hospitalised with NSTEMI.   "
45277|NCT02693002|"     Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12     weeks to determine if markers of systolic and diastolic function change by echocardiography     as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).   "
45278|NCT02692989|"     Trauma for hip joint is common in old people. Anesthesia in these types of old patients     carries more risk than the adult population.      In this study the investigators will review patient's records that underwent surgery for hip     trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the     rate of postoperative complications.   "
45279|NCT02692976|"     Prostate cancer is the only type of cancer in which conventional dendritic cells (DC)     treatment has a beneficial effect on the overall survival. In this study investigators aim to     show immunologic efficacy of tumor-peptide loaded natural DC in metastatic     castration-resistant prostate cancer patients (mCRPC).      The immunomonitoring will include:        1. functional response and tetramer analysis of delayed-type hypersensitivity infiltrating          lymphocytes against tumor peptides and        2. type I interferon (IFN) gene expression in peripheral blood mononuclear cells, and        3. proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin, a          immunogenic protein providing T cell help.      The secondary objectives are the safety and feasibility of natural DC vaccinations, the     influence on the quality of life during treatment with natural DC, and the clinical efficacy     of treatment.   "
45280|NCT02692963|"     The Bacillus Calmette-Guérin (BCG) vaccine, a live attenuated Mycobacterium bovis vaccine,     has been used to prevent tuberculosis for almost a century, and it is still the most used     vaccine in the world. There is also circumstantial and indirect evidence that BCG vaccination     can protect against malaria. Investigators hypothesize that BCG vaccination can offer     protection against malaria in the Controlled Human Malaria Infection (CHMI) model.      A total of 20 healthy male and female volunteers will participate in this randomized,     single-blind clinical trial. Volunteers will be randomized to receive either BCG vaccination     (BCG vaccine SSI) (group 1, n=10) or no treatment (group 2, n=10). Five weeks after     vaccination of group 1 volunteers, all volunteers will undergo a CHMI administered by the     bites of five P. falciparum infected Anopheles mosquitoes.   "
45737|NCT02686970|"     The aim of this study is to adapt and validate to the Spanish the European Quality     Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically     ill and dying patients in the ICU.   "
45283|NCT02692924|"     Background:      Gravid diseases are complications in pregnancy. They include gestational diabetes and     preeclampsia. These can cause problems with how a fetus grows. Being pregnant with twins can     make complications more likely. Research suggests that changes in fetal soft tissue may be     the earliest signs of growth problems. These tissue changes are in lean mass, fat mass, and     organ size. 3D images might detect these changes earlier than 2D images. This could help     manage gravid diseases. The NICHD Fetal Growth Studies - Singletons measured fetal growth for     four racial groups, Caucasian, African American, Asian, and Hispanic. Fetuses of obese women     and women with twins were also measured. 2D and 3D images were taken at various stages of     pregnancy. Measurements were taken after birth. Researchers want to expand this study by     measuring organ volumes and body composition by racial group and in twins.      Objectives:      To set standards for body composition and organ volumes by race. To understand the     relationship between gravid diseases and changes in fetal body composition and organ volume     over the course of pregnancy. To find out whether these are different for twins than for     single pregnancies.      Eligibility:      Women who participated in the NICHD Fetal Growth Studies - Singletons and Twins.      Design:      The data will come from the NICHD Fetal Growth Studies - Singletons and Twins.      Researchers will review scans taken in the previous study. They will take measurements from     the scans.   "
45284|NCT02692911|"     Background:      The gallbladder is a small organ below the liver. Gallbladder cancer is a leading cause of     cancer death among women in Chile. Chile also has among the highest rates of gallbladder     cancer and death in the world. Researchers in a high-risk region of Chile want to find out     more about this type of cancer. They especially want to know how inflammation affects the way     it develops.      Objective:      To better understand the causes of gallbladder diseases and factors that may be associated     with them.      Eligibility:      Women ages 50 74 with gallbladder cancer who are covered by the Chilean national health     system.      Other people over age 21 with gallbladder disease.      Healthy adults over age 21.      Design:      Participants may be screened with an ultrasound. They may be asked questions about their     health.      Participants will have an ultrasound of the abdomen. This can be done at the study clinic or     in the hospital or at home. The ultrasound uses sound waves to take pictures of the     gallbladder.      Participants will have a physical exam.      Participants will have their mouths looked at for tooth loss, dentures, and gum redness.      Participants will give a blood sample or saliva sample.      Participants will be asked for access to their medical history. They may be asked to allow     researchers to keep any samples taken during gallbladder surgery.      Participants will answer questions about their medical history. This will include illnesses,     surgeries, medicine use, and family history. It will also include diet and lifestyle habits,     such as places where they have lived and worked.      Some participants will have 3 follow-up visits over 6 years.   "
45285|NCT02692898|"     Background:      The number of people who get tumors of the brain or central nervous system (CNS) is lower     than other cancers. But these tumors cause a higher rate of serious effects and even death.     Researchers want to test existing samples of tissue from these tumors to learn more about     them. This may lead to better treatment.      Objective:      To study stored samples of CNS tumors to learn more about the tumors and explore new ways to     diagnose them.      Eligibility:      The study will use tissue samples already collected at NIH from people with brain or CNS     tumors.      Design:      The participants will have given their consent in a previous study.      Researchers will review the tissue samples and any data collected about them.      Researchers will do lab tests and scans on the samples.      All data will be kept secure.   "
45286|NCT02692885|"     Background:      The body uses energy from calories for basic functions like breathing and digesting food.     Over time, when a person eats more calories than they burn, they may become overweight or     obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue     to learn more about metabolism. That is how the body uses food and other nutrients for normal     function and energy. This research may help to develop new treatments for obesity and related     diseases.      Objective:      To learn more about the role of fat and muscle in metabolism, particularly how fat and muscle     store and use energy.      Eligibility:      Adults 18 years and older who have a planned surgery at NIH in which tissue can be collected     by the surgeon.      Design:      Participants will be screened by their regular NIH doctor. Then researchers will contact them     about this study.      Participants will not have to make extra visits to NIH for this study.      Researchers will collect samples during the participant s surgery. These will be fat tissue     and skeletal muscle tissue. Muscle tissue will only be taken from tissue that is going to be     discarded. Collecting the tissue will not add any time or any extra incisions than what is     required for the surgery.      After surgery, blood will be drawn. Some participants will have this done in the pre-op or     post-op room. Others will have this done during their hospital stay.   "
45287|NCT02692872|"     Background:      Alpha thalassemia is a blood disorder. It is caused by genetic deletions. Part of the DNA is     missing from a group of genes called alpha globin. Alpha thalassemias are some of the most     common genetic deletions. We are testing for alpha thalassemia trait. Alpha thalassemia trait     is when someone has only two out of the normal four alpha globin genes. In some people, they     lead to no symptoms. Others have changes that lead to disease, including mild anemia.     Researchers want to learn more about alpha thalassemia and blood vessels. This may allow them     to develop new treatments for blood diseases such as sickle cell disease.      Objective:      To better understand how alpha globin deletions in healthy people affect blood vessels.      Eligibility:      Healthy volunteers ages 18 50 who self-report African ancestry.      Design:      Participants will provide a one-time saliva sample. This can be by mail, in-person at a study     event, or at NIH.      Participants will get a small kit to collect their saliva sample. The kit has easy     instructions. The sample does not need to be put in the refrigerator.      Participants will spit a small amount of saliva (less than half a teaspoon) into a collection     tube.      Participants will close the funnel lid tightly, and then unscrew the funnel lid from the     tube. They will then close the tube tightly with the small cap provided and shake the tube     for 5 seconds.      Participants will place the tube in the provided envelope and mail it to NIH. The specimen     will be stored and processed in the lab.      Participants may be invited to participate in more research studies, whether or not     researchers find that they have alpha thalassemia trait.   "
45289|NCT02692846|"     Background:      Williams Syndrome (WS) is a genetic disorder. People with WS have less of a protein that     allows parts of the body to stretch than other individuals. Researchers are interested in the     stretchiness of the skin of people with WS and how it may relate to cardiovascular problems     some people with WS develop. They are also interested in identifying exposures such as     medications that may change the elasticity of the skin and vessels.      Objective:      To learn more about the skin and blood vessels in individuals with WS and how those tissues     change over time.      Eligibility:      People ages 5 70 with WS.      People ages 1 70 with a medical condition that affects connective tissue.      Design:      Participants will be screened with a review of their medical records.      Participants will have 1 visit. Participants with WS may do so at a Williams Syndrome     Association family meeting or camp, or at NIH. Other participants will be seen at NIH.      During the visit, participants will have height, weight, and blood pressure measured.      Researchers will listen to the participant s chest and abdomen.      Participants skin will be examined. It may be photographed.      Participants will have photos of their eyes and face taken.      Researchers will use a DermaLab Suction Cup Probe. A small suction cup will be placed on the     arm with a sticker. It will pull lightly on the skin. This allows a computer to measure skin     flexibility.      Researchers will use a SphygmoCor. A probe that looks like a dull pencil will be placed on     the wrist, neck, and groin area. A computer will measure how fast the pulse is moving and     will estimate blood vessel flexibility.      Participants may be invited to have these procedures repeated at a later date (2 years from     now or more).   "
45290|NCT02692833|"     The purpose of this study is to investigate whether biomarkers of cell senescence and aging     can predict the development of acute kidney injury following cardiac surgery.   "
45291|NCT02692820|"     Babies born preterm (before completing 37 weeks in the womb) are at increased risk of     long-term disability and death. The investigators do not fully understand the cause(s) of     preterm birth but it occurs more frequently when the normal, healthy bacteria (called     Lactobacilli) in a woman's birth canal are replaced with unhealthy bacteria. Previous     attempts to get rid of the unhealthy bacteria with antibiotics have not shown to affect the     risk of preterm birth. The reason for this may be that what is required is the replacement of     Lactobacilli in the birth canal. This can be done by asking women to take capsules containing     lactobacilli once daily. To study whether oral Lactobacilli capsules compared with dummy     capsules can reduce the risk of preterm birth, a large study involving approximately 10,000     women would be required. But the investigators do not know whether women would agree to take     part in and complete such a study, and this is what the investigators wish to study in the     small, initial study described here. The results of this study will show whether probiotics     produce the desired biological effects on vaginal bacteria, and whether it would be feasible     to perform the larger, definitive study of their effectiveness in prevention of preterm     birth.   "
45292|NCT02692807|"     The primary aim of this study is to determine the efficacy of hip arthroscopic surgery     compared to a sham surgery (diagnostic arthroscopy only) for patients with symptomatic and     radiological findings related to impingement (FAI) and/or labral tears using a randomized     controlled design (HIPARTI Study: Primary aim and the main paper: primary end point: iHOT 1     year follow-up)).      Our main hypothesis is that surgical procedures of the hip will demonstrate greater efficacy     than sham surgery (diagnostic hip arthroscopy only) for hip related quality of life (iHOT-33)     after 1 year and at further (HIPARTI Study).      The secondary aim of this study is to establish modifiable risk factors associated with pain,     function, work participation and quality of life over 1 year in people aged 18-50 years with     hip impingement and/or labral tears diagnosed at hip arthroscopy. (HARP Study: A separate     paper will be published with this main aim for the HARP Study) Long-term follow-ups for     HIPARTI Study as well as HARP Study will be performed at 2, 5 and 10 years (secondary aims     and separate papers).   "
45293|NCT02692794|"     Deliberate hypotension, reverse Trendelenburg position, and hyperventilation are techniques     utilized during functional endoscopic sinus surgery to attempt to reduce surgical bleeding.     These methods reduce blood flow to the head and neck area and assist in reducing bleeding     during surgery but they may predispose patients to cerebral ischemia. Large scale studies     necessary to conduct adequate statistical analysis regarding the effect of cerebral oximetry     on otolaryngology surgery has not been extensively studied. This study seek to address the     question of whether cerebral oximetry in the FESS population can help evaluate major and     minor post operative morbidity, as well as the quality of recovery from surgery. Cerebral     oximeters are small, noninvasive stickers applied to the forehead of participants and give     the examiners data regarding the level of oxygen saturation around the brain during the     course of surgery. During the course of such procedures, where blood flow to the head and     neck area is intentionally decreased to assist in reducing bleeding during surgery, the     levels of oxygen saturation around the brain may pose as a predictor or major and minor post     operative morbidity, as well as the quality of recovery from surgery. Outcome measures will     include major post operative complications, such as neurological and cardiac complications,     and minor post operative morbidity, such as length of post anesthesia care unit (PACU) length     of stay, nausea, and vomiting. Quality of recovery will also be assessed using a survey     conducted in the PACU and again at the first post operative visit approximately one week     after surgery.   "
45294|NCT02692781|"     MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active     moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM     and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The     peptide is a natural appetite suppressant, secreted by L-cells in the digestive system     following food intake leading to a decrease in gastric emptying, satiety after crossing the     blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being     developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food     intake and increase glycemic control.   "
45295|NCT02692768|"     The purpose of this study is to determine if music therapy interventions as adjunct to     standard surgical care reduces pre- and post-operative pain and anxiety in patients     undergoing total shoulder arthroplasty as compared with patients who receive standard of care     without music therapy.   "
45298|NCT02692729|"     This study aims to evaluate the efficacy and safety of transverse supraumbilical incision     over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.   "
45301|NCT02692690|"     Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart     failure.      Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation     (TENS). It is applied to strengthen the musculature and improve exercise tolerance and     quality of life.      It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients     with Optimizer® pacemaker systems for improvement of heart failure.      This pilot safety study enrolled 6 patients with chronic heart failure and reduced left     ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for     a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to     the study, and all were in clinically stable condition and willing to participate in this     study.      Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF)     on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients     were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the     Optimizer®-system respectively.   "
45302|NCT02692677|"     The purpose of this study is to assess the absorption, metabolism, and excretion of     JNJ-42756493 in healthy male adult participants after administration of a single oral dose of     12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.   "
45303|NCT02692664|"     In this study, patients will be observed who receive an E-liac Stent Graft for treatment of     isolated iliac aneurysms or an E-liac Stent Graft in combination with an E-tegra Stent Graft     for treatment of aorto-iliac aneurysms.      Objectives of this post-market registry are:      Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm     with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and     feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or     bilateral aorto-iliac or iliac aneurysm.   "
45304|NCT02692651|"     Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure     in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among     patients receiving CA, fidaxomicin is superior vancomycin. While these data are encouraging,     many clinicians remain unclear on how to apply these data to patient care. Additionally,     patients were excluded from the trials presented to the FDA if it was expected that they     would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply     these data to the real world patient who requires a long course of CA and develops CDI while     on therapy. We therefore propose an open label, comparative and prospective study of     fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment     of CDI among patients who are receiving a long course of CA.      We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure     for patients with CDI.   "
45305|NCT02692638|"     The goal is to assess the appropriateness of the standard practice of a trial of nonoperative     management for high grade small bowel obstruction (currently up to 72 hours based on     available literature). The investigator will offer early laparoscopic enterolysis (within 24     hours of admission) as the comparator group.   "
45306|NCT02692625|"     The purpose of this study is to evaluate the efficacy of probiotic products on     caries-associated salivary bacterial counts (Streptococcus mutans and Lactobacillus) and its     effect on dental plaque accumulation in a group of preschool children in Saudi Arabia.   "
45307|NCT02692612|"     The purpose of this project is to investigate the age-related differences in force-velocity     muscle characteristics during isolated knee extensions variable in speed and load, during     cyclic movements on a usual and recumbent bike variable in speed and velocity development and     a functional test battery with healthy participants aged between 20-80 years.   "
45308|NCT02692599|"     The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated     mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live     attenuated mumps vaccine as the control vaccine.   "
45309|NCT02692586|"     Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of     emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.   "
45310|NCT02692573|"     Investigators will compare 500 full term babies delivered by SCD randomized into two groups,     prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse     oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry,     respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of     life; beyond the initial 5minutes of life, monitoring as well as infant's management will be     done as per current Weiler hospital protocols. The intervention group will be placed in prone     position for first five minutes immediately after birth, and then changed to supine position.     The control group will be placed supine from birth. Investigators will check for the     incidence and severity of RD, supplemental oxygen need and duration, positive pressure     ventilation (PPV) need and duration or other use of respiratory support (intubation).     Additionally, investigators will record the number of infants requiring admission to the NICU     in each group, days of ventilatory support as well as the length of hospitalization.   "
45311|NCT02692560|"     The investigators are doing a study to learn how to support patients aged 60+ in taking more     breaks from sitting and reducing total sitting time. The goal of the study is to find out if     a sitting time reduction intervention reduces sitting time compared with a control group.   "
45312|NCT02692547|"     The purpose of this study is to collect data on the feasibility of the HLCL system in a camp     setting.   "
45313|NCT02692534|"     In this prospective study, investigators plan to evaluate the outcome of general anesthesia     in the context of patients with a positive cocaine urine test. Patients with a positive urine     cocaine test who do not appear acutely toxic and have normal vital signs may not have an     increased rate of perioperative complications during elective surgery compared to similar     patients with negative urine cocaine screening tests. Patients who are chronic cocaine users     may have a higher anesthetic requirement.   "
45314|NCT02692521|"     The purpose of this study is to discover the incentives and barriers to human milk use and     breast-feeding in the NICU graduate. By better understanding the incentives and barriers we     believe we can define better methods for promoting higher rates and longer duration of human     milk use in this medically fragile population.   "
45337|NCT02692222|"     This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac     Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV     and CO calculated by thermodilution.   "
45316|NCT02692495|"     This study is designed as a prospective cohort study to evaluate the potential of diagnostic     procedures in defining populations of patients self-reporting unexpected and uncontrollable     episodes of body odor and/or halitosis. Our initial cohort is generally healthy individuals     who already underwent multiple diagnostic tests recommended by their physicians and have not     been diagnosed with any known condition. The investigators will analyze results of     gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit to determine     if these tests are useful as potential screening tools for metabolic body odor and halitosis.   "
45317|NCT02692482|"     The aim of the present study is to assess whether the application of a new hydrocellular     polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to     standard care reduces the rate of pressure sores (PU) and their severity especially in the     elderly population admitted for fragility Hip Fractures.   "
45318|NCT02692469|"     Will a laparoscopic Single-Anastomosis Duodenal-ileal Bypass with Sleeve Gastrectomy produce     similar or superior results when compared to a laparoscopic Duodenal Switch, as a primary     surgical procedure for weight loss in bariatric patients over a 5 year period?   "
45319|NCT02692456|"     Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As,     it has Cross-section imaging system to avoids anatomic structures injury, it has high density     resolution that clearly display the retro-peritoneal anatomic structures ,it allow an optimal     puncture site selection and measured the angle and depth of the needle insertion accurately     with display the range of the neurolytic agent diffusion   "
45320|NCT02692443|"     Patients with hypoplastic left heart syndrome and other single right ventricle lesions who     have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that     affect quality of life and adulthood employment. This study will leverage the ongoing     National Heart, Lung, and Blood Institute (NHLBI)-funded Single Ventricle Reconstruction     Study by using innovative graph measures of brain connectivity to elucidate how alterations     of the connectome in children with critical congenital heart disease are associated with     developmental disabilities and their associated clinical risk factors. Improved understanding     of these interrelationships may facilitate development of targeted interventions to improve     outcome in the soaring population of adult Fontan survivors.   "
45321|NCT02692430|"     The purpose of this study is to perform a multicentre registry of cirrhotic patients who had     been submitted to an imagining technique in recent years (angio-CT scan or abdominal MRI), in     order to collect anatomical and clinical information. The main objective will be focused on     the study of portosystemic shunts and their relation with portal hypertension.      Patient with liver cirrhosis submitted to an abdominal angio-CT scan or a MRI from year 2010     to 2014 will be included in the study. The chosen imaging technique will be angio-CT     preferably, but MRI data will also be available. Patients will be identified in every     hospital by means of the registry of coded diagnoses and the lists of complementary tests     performed. Clinical and radiological data of every patient will be collected. The clinical     variables will be obtained from reviewing the patient clinical history. The radiological     parameters will be gathered by means of the systematic review of the angio-CT or MRI.   "
45322|NCT02692417|"     Female sexual dysfunction, including sexual arousal disorder, has a significant clinical     impact, affecting millions of women in the United States alone. Peripheral nerve stimulation,     such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve stimulation (DGNS)     can modulate neural circuits for bladder and fecal continence. The investigators hypothesize     that periodic DGNS and PTNS will modulate autonomic neural circuits and promote improvements     in sexual function in women with sexual arousal disorder. Subjects will be randomized to     receive one of the stimulation approaches. Subjects will have weekly 30-minute sessions     across twelve weeks.   "
45323|NCT02692404|"     In this pilot prospective longitudinal observational study, women who are pregnant and who     will be experiencing childbirth for the first time will be recruited at the third trimester     and observed longitudinally for psychiatric and pain characteristics until 3 months     postpartum. The primary outcome is postpartum depression, assessed by Edinburgh Postnatal     Depression Scale (EPDS). Infants will also be observed for infant development characteristics     over time. Women who choose to receive labor epidural analgesia will be observed, as well as     women who choose to avoid labor epidural analgesia. At baseline, women will complete baseline     surveys as well as a baseline pain sensitivity test (quantitative sensory testing, QST).     During labor, they will complete an electronic pain diary delivered by a bedside mobile     device. Three postpartum assessments will occur over 3 months to assess maternal depression,     other psychosocial variables, and infant development.   "
45324|NCT02692391|"     This is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the     efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ     failure and mortality in patients with AP and positive SIRS score.   "
45325|NCT02692378|"     The purpose of the study is to investigate whether oral sodium bicarbonate supplementation to     ensure a constant bicarbonate profile in haemodialysis patients will primarily lower     predialysis potassium levels and secondary lead to improvements in cardiac function, muscle     mass and dialysis related symptoms.   "
45326|NCT02692365|"     This is an exploratory, national, single-center, open-label study, being conducted at the     Institute of Education and Research of the Syrian-Lebanese Hospital in collaboration with the     Radiology Institute, the Heart Institute of the Faculty of Medicine of São Paulo, Hospital     São Paulo UNIFESP, and the Departments of Physics and Mathematics at the University of São     Paulo in order to detect the presence of calcium flux change, tumor perfusion and electrical     properties of tumor tissue when exposed to RF EMF AM by Cancer-frequency specific in patients     with advanced HCC and correlate these findings with hemodynamic changes assessed by     non-invasive hemodynamic measurements.      This study aims to demonstrate the presence of three mechanisms (hypothesis) that could be     involved in the hemodynamic changes and the specific antitumor effect induced by exposure to     RF EMF AM cancer-specific frequency. This study is not intended to study a therapeutic or     diagnostic procedure. For this reason, will not be considered evolutionary clinical data     during and after the intervention of the study.   "
45338|NCT02692209|"     The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm     FFDM plus DBT versus FFDM alone in the detection of breast cancer.   "
45327|NCT02692352|"     The main objective of this study is to examine the effect of Goal Management Training for     patients with executive difficulties after acquired brain injury in a randomized controlled     trial. The effect on cognitive functioning will be examined, as will the relationship between     treatment effects and lesion location and size. The effect of Goal Management training on     regulating emotions, quality of life and coping will be examined. The generalizability of     treatment effects across etiologies will be explored by comparing effects in three patient     groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors.     Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity     will be used to establish detailed lesion descriptions. Functional MRI data will provide     information on the neural underpinnings of treatment related change. A secondary objective is     to expand the Goal Management Training protocol with increased focus on emotional regulation     and adherence to homework assignment.   "
45328|NCT02692339|"     Multicentre, prospective, observational, open-label, single arm, post-marketing study     intended to record Lenalidomide/Dexamethasone treatment data from patients with     relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the     standard clinical practice and approved Summary of Product Characteristics (SmPC).   "
45329|NCT02692326|"     The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus     continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary     aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital     stay, mortality, nutritional status at two years of chronological age and predisposing     factors to the development of parenteral nutrition associated cholestasis (PNAC) between the     two groups, and to evaluate the adverse effects of the method of cycling used.      This was a single-center, prospective randomized not blinded study was conducted in a level 3     neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic     instability until a stable situation, congenital hepatic disease, preterm infants with     diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of     authorization from the parents or guardians were excluded.   "
45330|NCT02692313|"     Epinephrine is the principal physiologic defense against hypoglycemia in type 1 and longer     duration type 2 DM. Despite this, it is unknown how epinephrine regulates in-vivo endothelial     function and atherothrombotic balance in humans. The specific aim of our study will be to     determine the dose response effects of the key ANS counterregulatory hormone epinephrine on     endothelial function, fibrinolytic balance and pro-atherogenic inflammatory mechanisms in     healthy humans.   "
45331|NCT02692300|"     This study examines the potential link between deep levels of anesthesia and delirium.   "
45332|NCT02692287|"     The Postpartum Haemorrhage (PPH) Butterfly is a simple, low-cost device which has been     developed as a treatment method for PPH. It will be used to stop the bleeding through     compression of the uterus of women having a PPH. It will be markedly easier to undertake than     traditional bimanual compression, whilst also being significantly more acceptable to women     themselves. Use of the PPH Butterfly will provide an alternative management option for PPH     and in some cases should avoid the need for women to have to go to theatre for treatment.     This research will allow the investigators to determine if they have the optimum size and     shape of the device, that it will operate as intended when compressing the uterus, and to     gauge its acceptability to participants and users. In phase I the investigators will recruit     healthy volunteers i.e. women who have delivered their baby vaginally following Induction     of labour (IOL) however these women will not be experiencing a PPH. The device is to be     assessed purely on size, usability and acceptability not for diagnosis or as a treatment     method. Following the delivery participants will be invited to have the PPH Butterfly     inserted vaginally for an average of 2 minutes. It is through this that the investigators     will assess the suitability of the device in its current design, when it is in practice. The     clinician who operates the device will complete a Likert scale questionnaire along with some     open questions following each administration. Participants will also answer a short     questionnaire. .   "
45333|NCT02692274|"     Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in     resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South     Africa during the last 10-15 years. The investigators sought to determine the existing     availability, current usage and future need of POC tests among rural primary healthcare (PHC)     clinics in South Africa's KwaZulu-Natal Province.   "
45334|NCT02692261|"     Sinus augmentation is a predictable method when alveolar bone height is not sufficient for     dental implant placement in posterior maxillary alveolar region..The aim of this prospective,     randomized, controlled clinical study is comparison of hyaluronic acid originated matrix and     equine derived xenograft with only xenograft use in sinus augmentation by micro computed     tomography and histomorphometry.   "
45335|NCT02692248|"     Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with     rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maitenance in     patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell     transplantation (ASCT) An extensive biological study will be conducted in order to further     characterize this population of DLBCL patients and correlate the response obtained with the     biological profile of the tumor.   "
45336|NCT02692235|"     Research project objectives      The primary aims of the current research project are:        1. To investigate the effects of carnitine with leucine supplementation, in comparison to          carnitine supplementation alone, on muscle strength and body composition;        2. To use carnitine supplementation as the anti-inflammatory intervention for exploring the          relationship between inflammation and associated with aging reduction of skeletal muscle          mass;        3. To explore whether nutritional supplementation and resistance training might be combined          to produce synergistic effects in prevention of muscle loss during aging;      Hypothesis        1. Leucine stimulates carnitine transport into the muscle cells, which improve          mitochondrial capacity. Modification in energetic of skeletal muscle affects the body          composition and muscle performance;        2. The carnitine supplementation modulates the blood cytokines concentration.          Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated          with aging;        3. Resistance training combined with nutritional supplementation have more beneficial          effect than resistance training alone in prevention of muscle loss during aging;   "
45340|NCT02692183|"     A cornerstone in PD and ET research is the investigation of neurophysiological changes as     potential bio-markers that could help in tracking disease progression and response to     therapy. Electroencephalography (EEG) could provide a non-invasive and relatively inexpensive     tool for identification of such bio-markers. In this study the investigators will use     high-density electroencephalographic (EEG) recordings, in order to develop a platform of     sensitive and reliable bio-markers for disease progression and response to MR-guided Focused     ultrasound thalamotomy (FUS-T) intervention for tremor.   "
45341|NCT02692170|"     A single center, randomized, double blinded phase I/IIa exploratory study to evaluate     reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in     human adult   "
45342|NCT02692157|"     Healthy adult men who abuse opioids and are physically dependent on them will be invited to     participate in a study to examine the ability of NT-814, a neurokinin (NK) antagonist at the     1 and 3 receptor subtypes, to alter the abuse liability of oxycodone.   "
45343|NCT02692144|"     This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made     through a proprietary baking process combined with slow digestible carbohydrates and fiber     will elicit lower postprandial blood glucose and insulin responses than a Control-cluster     made from general processing procedure and with typical ingredients commonly used in     commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the     Test-cluster contains ~30% less available-carbohydrate (24g) than the Control (33g), the     postprandial responses elicited by the Test-cluster was also compared with those after a     portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25     healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with     fasting serum glucose <7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the     Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at     intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained     similar amounts of total carbohydrates, protein, fat and energy content. Each serving of     Test-cluster and White-bread had equivalent amount of 24g available carbohydrate.      On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by     finger-prick 5min apart and after the 2nd sample, the subject started to consume a test meal.     Subjects were asked to consume the entire test meal within 10 min. At the first bite a timer     was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40, 50, 60,     90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a separate     vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood samples were     obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample.     During the 4hr of the test, participants remained seated quietly. After the last blood sample     participants were offered a snack and then allowed to leave.   "
45344|NCT02692131|"     There is an increasing need for diagnostic modalities able to objectively quantify myocardial     function. Quantification of regional myocardial function with ultrasound is challenging on     its own. Visual assessment of wall motion and thickening requires extensive training [1] and     remains highly subjective [2]. Tissue deformation imaging is a recently introduced technique     which enables the objective assessment of regional myocardial deformation assessed by     ultrasound based strain and strain rate using Doppler Tissue Imaging or Speckle tracking.     There are limited number of studies comparing the myocardial deformation parameters (i.e.     Strain and Strain rate) by 2 different echocardiographic techniques viz Doppler tissue     imaging and Speckle tracking in the perioperative period. In this study, we plan to study the     above said parameters in patients undergoing coronary artery bypass grafting using     transesophageal echocardiography and correlate these parameters with cardiac output by     thermodilution method using pulmonary artery catheter.   "
45345|NCT02692118|"     Sepsis is still a challenge for clinicians since the detailed pathomechanism are still     unknown and until now early markers for sepsis are not defined yet. Immunological pathways     and new mediators defined in animal models are not yet investigated in patients with sepsis.     Therefore the investigators will measure new mediators in patients with septic shock.   "
45346|NCT02692105|"     This study will offer men with intermediate risk prostate cancer who are suitable for, and     interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate     (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard     of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also available as     a standard of care in BC but only when used as a boost in addition with external beam     radiotherapy. In addition, men will be offered the opportunity for testing the aggressiveness     of their cancer using Cell Cycle Progression Gene Profile.   "
45347|NCT02692092|"     HealthEast Care System began the first community-based joint replacement registry (HJRR) in     the U.S. in 1991, and now has more than 30,000 total joints registered. The purpose of the     HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery     by providing timely information to their surgeons and the broader orthopaedic community.      As it moves into the third decade, the HJRR is proud of its role in the development of the     national American Joint Replacement Registry (AJRR) and will remain an important contributor     to the larger national effort in the advancement of orthopaedic science.   "
45348|NCT02692079|"     This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF)     treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony     defects of patients with chronic periodontitis. In each patient, the infrabony defect of one     side of arch was designated as control group (allograft), while the infrabony defect on the     contralateral side of same arch was designated as test group (allograft+T-PRF).   "
45349|NCT02692066|"     Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant     recipients. Current recommendations suggest a 4 week waiting period between vaccination and     transplantation and consideration of booster immunizations if antibody response does not     reach target levels. This four week waiting period can result in delayed transplant,     rejection of an optimal organ, or missed opportunity to vaccinate. However, these     recommendations are not evidence based.      This is a prospective study to look at the immune response to varicella vaccine in children     with chronic liver disease.      Investigators will evaluate:        1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after          vaccination in children with chronic liver disease and        2. the difference in humoral and cell mediated immune response to varicella immunization          between children with chronic liver disease and healthy children.   "
45360|NCT02691923|"     This clinical research will evaluate the diagnostic potential of fluorescein as visualized     through an operating microscope relative to 1) contrast enhancement on co-registered     preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard     histology obtained from biopsy sampling during the procedure.      Subjects will include those people with operable brain tumor with first-time presumed     pre-surgical diagnosis of high-grade glioma or low-grade glioma.   "
45350|NCT02692053|"     Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of     inflammation, which could lead either to hypercoagulability or hypocoagulability. It is     currently not possible to determine the hemostatic status of a given patient. This     instability of hemostatic system is not revealed by classical tests. Thus, a better     characterization of hemostatic status could certainly improve patient care. This study aims     at characterizing disorders of coagulation and fibrinolysis using global tests such as     thrombin generation test or coagulolytic test. Furthermore, the association with biological     markers of interest (such as microparticles, neutrophil elastase or histones) will be     evaluated.   "
45351|NCT02692040|"     A randomised, placebo controlled Phase I study to investigate the safety, tolerability,     pharmacokinetics and pharmacodynamics of G3215 in adult subjects.   "
45352|NCT02692027|"     The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural     Lesotho. Participants who were tested HIV-positive during community-based HIV testing and     counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1     with parallel assignment.      Participants in the control arm follow the standard of care after a community-based HIV test     result: They are referred to the nearest clinic where they will receive baseline laboratory     testing and adherence counseling. After at least 2 clinic visits for adherence counseling     they can start anti-retroviral therapy (ART). After ART-initiation they have to attend     monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention     arm are proposed same day community-based ART initiation combined with less frequent     follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression     at 12 months after having tested HIV-positive during the community-based HIV testing and     counseling campaigns.   "
45353|NCT02692014|"     Coronary drug-eluting stent (DES) has been launched in China for more than ten years.     Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit     the progression of atherosclerosis plaque outside segments. It was shown that the progression     rate of non-target atherosclerosis plaque for patients with DES implantation was 6-10%, which     indicated that current secondary prevention for coronary heart disease (CHD) is far from the     achievement of ideal conditions.      Atherosclerosis has many risk factors based on current CHD guidelines, among which the level     of low-density lipoprotein (LDL) is the most concerned one. Large clinical studies on statins     were performed in the world during the past 20 years. It was demonstrated in these studies     that statins were significant to both primary and secondary preventions of CHD. What's more,     the lower of LDL level is reached, the lower incidence of clinical cardiovascular events is     achieved. However, cardiovascular events were still not avoidable especially for the     secondary prevention of CHD even if the level of LDL was significantly controlled under the     recommended range of guidelines by high dosage of statins.      It was shown in some recent studies that high loading dosage of statins may effectively     control the progression of coronary plaque. However, multiple studies found it was hard to     control the progression of all patients of coronary plaque due to individual difference.      Currently China Food and Drug Administration (CFDA) has not approved the loading dosage of     all statins because of possible high safety issues and confusions about the appropriate     application in Chinese patients, as well as economy burden to Chinese patients with high     treatment cost. How to evaluate individual progression risk of coronary plaque and enhance     risk factors control and the treatment of statins for necessary population, is currently an     issue, which should be solved in the diagnosis and treatment of CHD.      The inhibition in the progression of atherosclerosis plaque is not absolutely dependent on     the decrease of LDL. Large number of studies found other risk factors. For instance, diabetes     and chronic kidney diseases may also be associated with the progression of plaque. However,     the potential impact and control are still uncertain up to date.      Based on these background, we design a retrospective study, Risk Factors Promoting Coronary     Plaque Progression In China (The RIPPER Study), to solve these issues.   "
45354|NCT02692001|"     Childhood obesity is a major problem in Canada. Children are eating larger portions and have     easier access to high-fat, high-sugar foods and drinks. Menu labelling is a promising tool to     teach families about healthier choices. The investigators will study the impact of combining     child-friendly superhero food labels, fun food names, and a traffic light system on the food     choices of children and their parents at SickKids. The investigators will use the hospital     inpatient food ordering system (Meal Train) and look at food orders and eating patterns     before and after introduction of the revised Meal Train menu. Only the design format of the     menu was changed and all menu items remained unchanged. The investigators will also survey     the families on their thoughts about the menu. This study will help doctors and dietitians     develop strategies to deliver nutrition education to families.   "
45355|NCT02691988|"     Rationale: Because long-term use of ICS is associated with an increased likelihood of     side-effects such as increased risk of pneumonia and loss of bone density, it is important to     limit prescription of ICS to patients who have a clear indication for this treatment. In     addition, avoiding unnecessary treatment with ICS could reduce the burden that chronic     obstructive pulmonary disease (COPD) puts on healthcare budgets. The recently updated COPD     guideline of the Dutch college of General Practitioners (NHG) emphasizes the importance of     optimizing medical treatment for COPD patients with only limited room for the use of inhaled     corticosteroids.      Objective: The objective of the study is to investigate whether discontinuation of inhaled     corticosteroids (ICS) for patients without a clear indication for ICS according to current     guidelines results in a reduction of ICS use without adverse health effects for the patients     involved.      Study design: The study is a pragmatic, clustered, parallel group, non-inferiority trial in     Dutch general practices with a follow-up of 26 weeks per patient.      Study population: 620 COPD patients with confirmed chronic airflow obstruction, aged ≥ 40 yrs     who use ICS for at least the prior 6 months without a clear indication.      Intervention (if applicable): Guided ICS withdrawal in optimised COPD management. All study     participants (of both study arms) will receive recommendations on optimal bronchodilator     therapy and a personalized action plan to recognize symptom deterioration in an early stage.      Main study parameters/endpoints: Number of exacerbation-free weeks. Secondary study     parameters: successful cessation of ICS, time to first exacerbation, number of moderate and     severe exacerbations, health-related quality of life, health status, and pneumonias.     Moreover, information on the process of care and costs will be collected.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Many COPD patients use ICS without a clear indication. Long-term use of ICS is     associated with an increased likelihood of side-effects such as increased risk of pneumonia     and loss of bone density and should be avoided in those who do not benefit from it. However,     there is a small subgroup of COPD patients that have reduced numbers of exacerbations because     of their ICS use and it is impossible to identify a priori the patients who this applies too.     Therefore, it is important that the ICS discontinuation is guided to detect potential     deteriorations early on.   "
45356|NCT02691975|"     This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in     patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will     receive SHR3680.   "
45357|NCT02691962|"     This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral     or incisional midline hernia repair in patients across all wound classes (All Comers)     through 24 months post repair.   "
45358|NCT02691949|"     Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality     of life in patients with Sjogren's syndrome. Mycophenolate also has excellent     immunomodulation effects in lupus nephritis. Currently Mycophenolate is only used in lupus     nephritis and organ transplant. It is unknown whether low dosage of mycophenolate mofetil     could be used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.   "
45359|NCT02691936|"     This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2     fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of     vulvovaginal atrophy/GSM.   "
45361|NCT02691910|"     This is a randomized open-label trial to evaluate the efficacy of chloroquine (CQ) alone     compared to chloroquine+primaquine (CQ+PQ) in the treatment of uncomplicated malaria caused     by Plasmodium vivax infection in a endemic area in the westernmost part of the Amazon Basin     of Brazil. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was     28 days. The duration of complete follow up to detect recurrent P. vivax infections by     passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ     treatment (3.5mg/kg total dose) starting on day 28 of the study follow-up.   "
45362|NCT02691897|"     The aim of this study is to assess the efficacy and safety of melatonin in control of blood     sugar in patients with type 2 diabetes mellitus (DM).   "
45363|NCT02691884|"     The aim of the study is to assess the change of fetal heart rate in response to the amount of     pressure exerted on the maternal abdomen. The amount of pressure will be quantified using an     electronic pressure sensor (FSR 400- Round Force Sensor, Interlink).   "
45364|NCT02691871|"     The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750 mg/d     with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients     harboring wild-type EGFR after failure of first line chemotherapy and to determine the     recommended dose for the Phase II trial.   "
45365|NCT02691858|"     Intussusception is one of the most frequent causes of acute bowel and second most common     cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are     either due to pathological lead point or post operative. Treatment of intussusception must     start with medical resuscitation, then radiological or operative reduction of     intussusception.      Our surgery team has used hydrocortisone with the medical resuscitation to improve the     success rate of pneumatic reduction and decrease the number of reduction trials.   "
45366|NCT02691845|"     The investigators propose a randomized clinical trial in which 240 depressed individuals are     assigned to one of three arms, with each successive arm having an added component that may     serve to increase and maintain physical activity:        1. brief advice (BA) to exercise (control condition);        2. BA + supervised & home-based exercise (SHE) + health education (HE) contact control; and        3. BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise          (CBEX).      The primary aim is to assess and optimize the safety, feasibility, acceptability of each     intervention component, as well as barriers limiting their effectiveness in order to prepare     for a larger scale randomized clinical trial.   "
45367|NCT02691832|"     The Double Sensor examined in this trial was developed by Dräger Company and is a novel non-     invasive device for assessing core body temperature. In a preliminary research investigators     have conducted the Double Sensor was found promising for potential use of physiological heat     stress early detection. This follow-up experiment was designed to validate the data during     high and changing body core temperatures and to examine the Double Sensor performance while     integrated into a helmet as in intended application.   "
45368|NCT02691819|"     At the same time in the side branch stent expansion vessels were embedded and balloon     dilatation technique in for Medina1.1.1 type, 1.0.1 type or 0.1.1 type lesions of     interventional therapy for bifurcation lesions, the PCI preoperative and postoperative 6 h,     24h of all patients were at least three times ECG and assay of creatine kinase isoenzyme     (CK-MB) and cardiac troponin T (TNT data analysis); immediately after operation and nine     months after surgery, coronary angiography, quantitative coronary angiography, evaluation of     each main branch and side branch of the lesion degree of stenosis (determination of     bifurcation angle, reference vessel diameter, vessel diameter, minimum) and TIMI flow grade;     using 256 slice spiral CT scanner to scan each main branch lesion and evaluation a side     branch stenosis (determination of bifurcation angle, reference vessel diameter, vessel     diameter, minimum). All patients were followed up for 1 months, 6 months, and 9 months     follow-up. Cardiovascular events included total cause of death, cardiac death, total re     hospitalization rate, recurrent myocardial infarction or unstable angina.   "
45369|NCT02691806|"     Sometimes, during strenuous aerobic activity, activity ceases only when the discomfort that     follows lack of oxygen would be intolerable. Reaching this fatigue condition can cause organ     damage, muscular damage and / or in different tissues of the body. In this study,     investigators aim at developing new indexes, based on hemodynamics measurements from the     peripheral micro - circulation system, for the benefit of early detection of fatigue during     accelerated physical activity.   "
45370|NCT02691793|"     This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive,     FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by     Avatar scan that has progressed following standard therapy or that has not responded to     standard therapy or for which there is no standard therapy.      To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.   "
45371|NCT02691780|"     This study is a single arm, pilot study of Sorafenib in patient with BRAF mutation Refractory     solid tumor and specific sensitivity to Sorafenib by Avatar scan that has progressed     following standard therapy or that has not responded to standard therapy or for which there     is no standard therapy.      To investigate the efficacy and safety of Sorafenib in patient with Refractory solid tumor.   "
45372|NCT02691767|"     This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification     Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has     progressed following standard therapy or that has not responded to standard therapy or for     which there is no standard therapy.      To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.   "
45373|NCT02691754|"     Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but it     is not included in list of drugs than can be prescribed in charge of National Health System     by General Practitioners. The hypothesis is that removing this economical barrier the     investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors (PPI),     often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary outcome,     opioids use was also monitored to see.      Aim of the study is to test if allowing prescription of free paracetamol decreases the     prescription of NSAID in osteoarthritic patients.   "
45374|NCT02691728|"     This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in     patients with Chronic GT1 or GT4 HCV infection and autoimmune disease   "
45375|NCT02691715|"     Investigator will examined the diagnostic effect of the endometrial washing by saline.     Because this technique more less painful and easier compared to endometrial curettage.     Participants will separate into two groups. In study groups before endometrial curettage 5 cc     saline infused to the endometrial cavity then aspirate and put into thin prep to examined.     After this procedure routine endometrial curettage will be done. In control group only     endometrial curettage will be done. Pathologic results of thin prep and curettage will     compared.   "
45376|NCT02691702|"     This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult     and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK)     and pharmacodynamics (PD) of PF 05251749   "
45377|NCT02691689|"     Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is     associated with considerable morbidity and even mortality.      Next to environmental risk factors, the investigators believe that there is an important role     of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the     severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The     investigators hypothesize that the genotype is partly responsible for the phenotypic     variability in patients with congenital shunt lesions, where some develop PAH and others do     not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening     could be a useful additional tool for early detection of patients at risk of pulmonary     vascular disease and PAH development, with new opportunities for prevention or early     treatment.   "
45378|NCT02691676|"     Introduction: The strategy of perioperative fluid therapy has an important impact not only on     the circulating volume and perfusion of organs and tissues but also on the patient's internal     environment. The study aimed at comparing the effects of perioperatively administered     balanced crystalloid infusion solutions containing different amounts of metabolizable anions     on homeostasis.      Methods: In the prospective randomized study, patients were assigned to Plasmalyte (PL) and     Ringerfundin (RF) Groups after their postoperative transfer to an intensive care unit (ICU).     The infusion solutions were parenterally administered at 1000 mL/6 hours. Arterialized     capillary blood was sampled at the time of transfer to the ICU (Time 0), and again at 2 hours     and 6 hours from Time 0. The collected blood was tested for blood gas parameters using the     Astrup method.   "
45379|NCT02691663|"     The purpose of this research study is to determine the effect of a bicarbonate supplement on     kidney function and physical function.   "
45380|NCT02691650|"     Goal of this study is to measure serum cholinesterase activity in patients with traumatic     and/or burns injury admitted to the emergency room by using point-of- care-test system     (POCT). Serum cholinesterase activity, measured using POCT system, might play an important     role in the early diagnosis and prediction of patient outcome in trauma-induced systemic     inflammation.   "
45381|NCT02691637|"     Helicobacter pylori (H. pylori) infection has been associated with a development of atrophic     gastritis and intestinal metaplasia. H. pylori related atrophic gastritis and intestinal     metaplasia have been regarded as pre-malignant lesion. However, the role of H. pylori     eradication treatment in the reversibility of atrophic gastritis and intestinal metaplasia     has not been clearly defined. The aim of the present study was to investigate the     relationship between H. pylori eradication and the reversibility of atrophic gastritis and     intestinal metaplasia in Korean patients.   "
45382|NCT02691624|"     Lymphoscintigraphy is a noninvasive，accurate and effective imaging modality. In this study,     it is used to investigate the imaging characteristics of patients'upper limb lymphatic     drainage before operation, and the influence of operation on it.   "
45383|NCT02691611|"     The investigators hypothesize that environmentally influenced histone modifications regulate     AM mediated inflammation, contributing to a variable clinical course of AATD, and may also     influence or be influenced by the activity of AAT augmentation therapy.   "
45384|NCT02691598|"     Cytokines such as such as TNF-a, IL-1, IL-6 correlate with the severity of     pancreatitis.Neuroendocrine pathways, such as the sympathetic nervous system or     parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2     adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. The investigators     aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous     system, thus relieve inflammation response.   "
45385|NCT02691585|"     Blood pressure (BP) reduced significantly after listening to Indian music among     prehypertensives and hypertensives in all subjects who were given a musical piece composed on     raga 'bhimpalas' (raga that normalizes BP) to be heard daily for 3 months. On retrospection     into the methodology, the effect of a single raga (Bhimpalas) alone had been tested. Heart     rate variability (HRV) recorded once on recruitment and followed up after 3 months failed to     show any change. The acute effect of music on HRV while listening to raga bhimpalas, and the     effect of all ragas listed in Gandharva veda had not been tested. Respiratory rate was not     controlled (affects HRV) and EEG waves were not studied.   "
45386|NCT02691572|"     The study will compare the analgesic efficacy of transversus abdominis plane block and wound     infiltration in parturients undergoing cesarean delivery under spinal anesthesia.   "
45387|NCT02691559|"     Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as PPROM,     prematurity or fetal distress. It is known that fetal urine is the major content of AF since     20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract, umbilical     cord and fetal side of placenta are important sources for AF. Bombesin-like peptides,     8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin, sphingomyelin,     lamellar body in FAF are molecules acting on fetal lung maturation. Varying levels of these     molecules relevant to the stage of lung maturation may constitute an association to AF pHTo     detect the possible effect of AF pH on neonatal respiratory morbidities 1 milliliters of AF     is aspirated during C-section before incision of membranes. pH value of AFs were analyzed by     the blood gas machine (Siemens RAPIDLab®1200 Systems) of NICU. Maternal and neonatal     demographic features and clinical outcomes, incidences of morbidities such as respiratory     distress syndrome (RDS), transient tachypnea of the newborn (TTN) are all recorded.   "
45456|NCT02690649|"     This is an interventional study designed to develop patient focused strategies that improve     adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF).     Outcomes of this work include a novel intervention, as well as information regarding patient     preferences for tailored education.   "
45389|NCT02691533|"     Study population: Patients admitted or seen in OPD (Out Patient Department), Department of     Hepatology.      Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017     Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA     (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).      Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).      Group C -Placebo group      Monitoring and assessment- :- The following tests will be done in these patients:-        1. Complete clinical examination.        2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels        3. BUN (Blood Urea Nitrogen)        4. Serum free fatty acid levels        5. Lipid profile.        6. Arterial ammonia        7. Arterial lactate        8. Blood sugar and serum insulin levels   "
45390|NCT02691520|"     The purpose of this study is to assess the epidemiology of Treatment Resistant Depression     (TRD) in the nationally insured population in Taiwan including incidence, duration of     clinical episodes, and prevalence by age and sex.   "
45391|NCT02691507|"     The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC)     1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.   "
45392|NCT02691494|"     This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in     combination with estradiol/norethindrone acetate for the management of heavy menstrual     bleeding associated with uterine fibroids in premenopausal women.   "
45393|NCT02691481|"     Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical     nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and     enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma     glucose is not yet known.      The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma     glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty     acids (FFA) and serum triglycerides (TG).   "
45394|NCT02691468|"     The purpose of this study is to compare difference of displacement between Polyvinyl     Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position     from supine to lateral in thoracic surgery.   "
45395|NCT02691455|"     Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt     implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.   "
45396|NCT02691442|"     Several reports have compared the duration of action of levobupivacaine and ropivacaine as     local anesthetic. The most widely used method for sensory function evaluation is though means     of a pinprick test. The investigators want to use the novel method of Quantitative Sensory     Testing to better evaluate the anesthetic activity. This method used hot and cold sensation     to assess small nerve fiber function. The investigators will assess the duration of action of     different drugs when used in an inter scalene nerve block in patients scheduled for shoulder     surgery.   "
45397|NCT02691429|"     Our research group tested the toxicity of different dye concentrations extracted from the     acai fruit using a rabbit model. The dye extracted from the acai fruit in concentrations of     10% and 25% was found to be safe for vitreoretinal surgery. This initial research represented     the landmark research for testing this alternative vital dye in a clinical research in     humans.      The aim of the present clinical trial in humans will be to test the applicability of the acai     dye in the identification of the posterior hyaloid and ILM during vitreoretinal surgery in     humans.   "
45398|NCT02691416|"     The purpose of this study was to evaluate differences between propofol postconditioning and     sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.   "
45399|NCT02691403|"     Patients undergoing abdominal procedures often require multimodal postoperative pain     controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a     part of it. The investigators hypothesized that the ultrasound-guided QL block with     transmuscular approach can provide adequate pain relief for colostomy closure as part of a     multimodal pain control.   "
45400|NCT02691390|"     dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for     at least two weeks.   "
45401|NCT02691377|"     The purpose of this study is to determine whether acupuncture is effective and safe in the     treatment of Primary Sjögren Syndrome.   "
45402|NCT02691364|"     Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is     necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in     reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and     preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T     cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory     cells are not known. The main objective of this study is to analyze the effect of     preeclampsia on levels of immune cells.   "
45403|NCT02691351|"     The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing     effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about     conical features and treatment outcomes of each subtype should be accumulated to establish     treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma     was from small case series of single institute. Furthermore, as novel drugs were developed     for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were     treated with those novel drugs are especially required because their outcomes may reflect the     outcomes of currently available treatments. Thus, a multinational, multicenter prospective     registry study is needed to provide information useful for establishing treatment strategies     for T-cell lymphoma.   "
45457|NCT02690636|"     Breast cancer patients operated with modified radical mastectomy or breast conservative     surgery will be randomized for either adjuvant conventional radiotherapy versus     hypofractionated radiotherapy for chest wall and axilla or breast and axilla.      The patients will be recruited for one year and will be followed for 5 years by monitoring     local recurrence, cosmetic outcomes, health economic perspectives, and arm lymph edema.   "
45752|NCT02686775|"     The randomized trial evaluates whether assigning a patient coach to vulnerable lung cancer     patients will empower these patients to participate in the treatment decision process, help     patients navigate the health care system while undergoing treatment and adhere to cancer     treatment and to recommendations for supportive care. Half of the participants will receive     standard care and be offered a patient coach while the other half will receive standard care.   "
45404|NCT02691338|"     The incidence of perioperative stroke in the non-cardiac, non-vascular, non-neurological high     risk surgical population is 2%. It is higher (~5%) for cardiac surgery and carotid     endarterectomy patients, with a stroke associated mortality of up to 60%. These patients     could be immediately treated if their condition was detected on time. Currently, there is no     standard brain monitoring procedure for anaesthetised patients. The purpose of the proposed     study is to optimize and validate an online monitor for neurological deterioration under     anaesthesia based on an easily operatable EEG system comprised of 4 electrodes, a reference     electrode and a newely developed algorithm for analyzing the EEG signal. The monitor aims at     generating an immediate warning at the onset of neurological deterioration. For the purpose     of technology development with a minimal sample size, it is necessary to select a patient     population that demonstrates significant neurological dynamics under anaesthesia. We will     therefore focus on anesthesized patients undergoing neurovascular thrombectomy after CVA.   "
45405|NCT02691325|"     GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor     being developed as an anti-inflammatory and anti-infective agent for the treatment of     inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts.     The aim of Part A and B of the study are to assess the safety, tolerability and     pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557 administered     via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first study in     which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will     investigate the proportion of the systemic exposure that post inhalation is due to the     swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA     device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C     may be run sequentially or in parallel. Part A is a randomized, double blind, placebo     controlled, single dose, dose escalating incomplete block 2-period crossover study in healthy     subjects. Subjects will be randomized to receive either one dose strength of GSK2269557 and     placebo utilizing placebo replacement, or will receive both active dose strengths. Part B is     a randomized, double blind, placebo controlled, repeat dose study in healthy Subjects.     Subjects will be randomized to receive either repeat doses of GSK2269557 or placebo for 10     days. Part C is a, randomized, open-label, crossover design to assess the systemic exposure     of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy subjects, with and     without ingestion of activated charcoal. ELLIPTA is the registered trademark of     GlaxoSmithKline groups of companies.   "
45406|NCT02691312|"     Diabetic retinopathy (DR) causes more new cases of blindness among young adults than any     other disease. More than 90% of individuals with type 1 diabetes (T1D) will have some form of     DR by 20 years after their diagnosis. DR is associated with long-term hyperglycemia and blood     glucose variability, which induces vascular endothelial dysfunction and destruction in the     retina, eventual retinal ischemia, and in the end, widespread neovascularization of the     retina and optic disk. When these fragile vessels bleed, they can cause vitreous hemorrhage     and loss of vision. Eventually the friable vessels fibrose and can result in retinal     detachment or further retinal ischemia.      Major risk factors for the development of diabetic retinopathy are time since diagnosis, age     at diagnosis, and severity of hyperglycemia. Retinopathy most commonly occurs at least three     years after diagnosis and most cases are diagnosed more than five years after the onset of     T1D. Current guidelines from the American Diabetes Association (ADA) and American Academy of     Ophthalmology (AAO) recommend that patients with T1D undergo an initial comprehensive dilated     fundoscopic evaluation once the individual has had diabetes for 3-5 years and has either     reached puberty or 10 years of age, whichever is earlier. These patients should receive a     yearly exam thereafter, or every two years based upon the recommendation of an eye care     professional. However, the prevalence of retinopathy in children is unknown and adherence to     these guidelines, especially in youth, has proven difficult. Thus, it is important to make     these guidelines more evidence based, as retinopathy is often asymptomatic until vision loss     occurs. The first step in this process is the determination of the prevalence of retinopathy     in a general population of youth with diabetes. This should be followed by determining which     children are most at risk, so the guidelines can provide realistic and pertinent guidance to     practitioners.   "
45407|NCT02691299|"     Fruquintinib/Placebo 5 mg, QD, orally administered under fasting conditions for 3 consecutive     weeks followed by one-week off to evaluate the survival benefit of patients with advanced     non-squamous NSCLC treated with Fruquintinib.   "
45408|NCT02691286|"     The aim of the study is knowing the prognostic value of circulating miRNAs in patients     admitted to our hospital with STEMI complicated with cardiogenic shock.   "
45409|NCT02691273|"     It was found that an important part of the factors impeding adherence to medication and a     healthy lifestyle among the chronically ill diabetic patients lies in proper management of     the disease. Since it is a chronic progressive disease the caregiver is the patient     himself.Studies have shown that software system, sending text messages / messages / reminders     daily and answering questionnaires can improve adherence to a change in lifestyle.      This study is an initial pilot study , which examines Feasibility ( Applicability ) of using     a smart application that promotes a healthy lifestyle perseverance parallel use relaxation     techniques .   "
45411|NCT02691247|"     This clinical trial will explore the safety and effect of autologous ex vivo expanded     polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent     onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM     will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or     low dose) or placebo.   "
45412|NCT02691234|"     Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for     the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in     accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of     Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate,     increased cell proliferation and cell activity and decreased cell apoptosis.      The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave     treatment will be done together with the standard conventional treatment for DFUs, compared     to a control group who will receive the same conventional standard of care.   "
45413|NCT02691221|"     The purpose of this study is to increase use and availability, as well as assess the     feasibility of the ReliefLink (RL) application for use in conjunction with standard care to     promote psychological health and prevent suicidal behavior.   "
46650|NCT02675010|"     There are controversies about the best sites -biopsy based -tests for H pylori associated     gastritis. The study is designed to evaluate the optimal site of gastric mucosal biopsy for     identification of Helicobacter pylori, especially in case of gastric atrophy and/or     intestinal metaplasia.   "
45414|NCT02691208|"     The patients were divided into two randomized groups with 24 patients per group, which were     given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes     and the other group followed Kinesiotherapy the same protocol for another 30 minutes     acupuncture using predefined points.      The patients were assessed at baseline, after five weeks and at the end of 10 weeks.     Responded to an evaluation form about their registration and social data. The physical     examination included the assessment of shoulder range of motion, shoulder muscle strength,     circumference of the upper limbs and the presence of pain. Questionnaires of quality of life,     upper limb function and depression.   "
45415|NCT02691195|"     Regional anesthesia improves quality of recovery after surgery in many studies.     Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative     to current regional anesthetic techniques. This randomized, controlled trial is to examine     the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast     tumor resection.   "
45416|NCT02691182|"     Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid     with ADHD and have participated in the 810P301 or 810P302 study are invited to participate in     this study. This is a Phase 3 open label extension (OLE) study with the objective of     collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in     pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After     confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be given     a choice to extend participation in this study every 6 months for up to 36 months.   "
45417|NCT02691169|"     There are several new therapies available to treat men with advanced prostate cancer;     however, the decision making tools needed to determine the best treatment for these patients     are noticeably absent. The prostate-specific membrane antigen (PSMA) is increasingly being     recognized as an important target for prostate cancer imaging and determining the most     effective therapy. Accordingly, a wide variety of agents are being used to image PSMA. One of     these agents is 18F-DCFPyL. In this study the investigators will image men with advanced     prostate cancer using 18F-DCFPyL and a positron emission computed tomography (PET/CT)     scanner. The investigators will compare the results of 18F-DCFPyL PET/CT for the detection of     metastases and monitoring the effects of therapy with conventional imaging (CT, bone scan)     and clinical follow-up. In this way, the investigators will evaluate the benefit of using     18F-DCFPyL PET/CT to decide what is the best treatment strategy for a man with advanced     prostate cancer.   "
45418|NCT02691156|"     Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the     intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific     total bilirubin level and need for intervention has been elusive. This is most likely due to     other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even     interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy     has impacted clinical and family-centered care, and in the extreme preterm infants, it may     have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy     in in order to reduce its use is unique. The investigators have assembled a transdisciplinary     team to examine critical unanswered questions including the role of bilirubin binding     capacity (BBC) of an individual during the first week of life in the context of clinical     modifiers and antecedents for a domain of bilirubin-induced neurologic disorders, that     includes neuro-anatomical, hearing, visual and developmental processing impairments. In this     study, the investigator will evaluate two new innovative nanotechniques to quantify bilirubin     load for the first time in the context of a clinical decision algorithm to identify those     most at risk for any bilirubin-related neurotoxicity. The investigators anticipate that     knowledge gained from this study will lead to ethically testable hypotheses to individualize     the prescription of phototherapy.   "
45419|NCT02691143|"     The purpose of this study is to determine if post-manipulation elastic therapeutic tape (ETT)     with TheraBand® Kinesiology Tape to neck pain patients can impact neck range of motion (ROM)     and post-manipulation pain. A convenience sample of 50 patients, between the ages of 18-64,     who present with acute non-complicated postural neck pain will be recruited from an     outpatient chiropractic clinic. Upon providing consent to participate, patients will be     randomly assigned into 2 groups; Control Group (manipulation only) and Tape Group     (manipulation plus tape). Pain and neck ROM will be recorded at 3 different intervals: (1)     pre-cervical manipulation, (2) within 5 minutes of cervical manipulation, (3) with 24-48     hours after manipulation.   "
45420|NCT02691130|"     Multimeric-001 (M-001) contains conserved, common linear influenza epitopes that activate     both cellular and humoral arms of the immune system against a wide variety of influenza A and     B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune     responses to pandemic influenza vaccine in the adult population. The current clinical study     was designed to assess M-001's standalone and priming action in subjects aged 18-60 years     old.      This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to     receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two     placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.   "
45421|NCT02691117|"     Management of pediatric alopecia is particularly challenging given the chronicity of the     condition, limited therapeutic response and devastating psychological effects. There is a     paucity of safe and effective therapies in this population.      The investigators propose to conduct and open label, prospective cohort pilot study using     topical garlic concentrate ( GarlicRich) for treatment of children with alopecia areata.     Study medication will be applied topically on affected area of the skin daily for 6 months.     Follow up visits will occur monthly to access the efficacy and safety of the proposed     treatment .   "
45422|NCT02691104|"     The investigators are carrying out a feasibility study to explore whether an app for physical     activity in Chronic Obstructive Pulmonary Disease (COPD) is acceptable to people with the     condition and to healthcare professionals who help patients manage the condition.   "
45423|NCT02691078|"     Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA     (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the     111In - DTPA-octreotide.   "
46706|NCT02674282|"     Our purpose is to evaluate maximum oxygen uptake (VO2max) in ACL-injured professional soccer     players and after a six-month period of post-operative rehabilitation, compared to a control     group of healthy professional soccer players.   "
45424|NCT02691065|"     Human immunodeficiency virus (HIV) infection damages body defence mainly by affecting two     important white blood cells called cluster of differentiation (CD4) T cells and monocytes.     This immune dysfunction leads to persistent inflammation, which is partially resolved with     long-term anti-HIV therapy. Importantly, such inflammation increases risk for cardiovascular,     diabetes, and kidney diseases. The causes of this inflammation are largely unknown and     include HIV itself, presence of other infections, lifestyle characteristics like increased     cholesterol levels, obesity, smoking and alcohol abuse. In addition, inflammation can be     driven by certain type of anti-HIV therapy called protease inhibitor (PI). PI has been     associated with an increase of cholesterol and may contribute to inflammation. A new class of     medication that is now available in Canada called integrase inhibitor (II) may have a lesser     or no effect on cholesterol levels. Therefore, it is important to study the effect of II on     cholesterol levels and inflammation.      The purpose of this study is to assess the inflammatory changes, in the blood of persons     treated with PI that will switch to the II or may remain on their PI-containing regimen. By     comparing persons continuing their current PI-based regimen with those who switch to II-based     regimen, we will know if the change from PI to raltegravir (Isentress), a type of II,     decreases lipids and inflammatory markers.      The adult persons living with HIV, who are on PI-based therapy for more than a year, with any     CD4 T cell count and plasma viral load below level of detection, will be invited to     participate in the study. 40 study participants will be selected by randomization (like a     toss of a coin) to either continue PI-based regimen (20 participants) or switch to     raltegravir-based regimen (20 participants) for a period of 12 months. Blood samples of the     study participants will be drawn before, during and at the end of study to evaluate changes     in markers of inflammation, cholesterol level and CD4 T cell and monocyte function. No     experimental anti-HIV medication will be used; change of therapy will include raltegravir     which is one of currently recommended medications to treat HIV in Canada.      This study will be able to answer this important question whether inflammation can be     decreased by switching therapy from PI-based therapy to raltegravir-based therapy.     Ultimately, information provided by this study will contribute to the health of persons     living with HIV.   "
45425|NCT02691052|"     Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine     vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL)     under this combination therapy. In the framework of a German multicenter prospective,     observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under     treatment will be analyzed and data will be compared to existing data of the gemcitabine mono     therapy.      QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over     a 6-month period. Additionally patients are requested to answer a supplementary questionnaire     addressing e.g. fears related to QoL deterioration and side effects of chemotherapy. Primary     endpoint is the proportion of patients with maintained Global Health Status/QoL at 3 months     (10 points threshold). 600 patients shall be enrolled at about 90 study sites in Germany.   "
45426|NCT02691039|"     The purpose of this project is to create a database to collect information about the NEW     Keiki Program. The information collected for this project will be used to evaluate the     program. The NEW Keiki program promotes healthy lifestyles and behavior changes.   "
45427|NCT02691026|"     This is phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475) in     subjects with metastatic or locally advanced/unresectable or metastatic malignant peripheral     nerve sheath tumour (MPNST).      The patients will be treated with pembrolizumab for up to 10 cycles.      Primary objective is to evaluate the percentage of patients with curatively unresectable     MPNST who have achieved clinical response; complete response (CR), partial response (PR), or     stable disease (SD) at 18 weeks as assessed by the Investigator, by using RECIST, v1.1.   "
45428|NCT02691013|"     Sleep deprivation is known to affect brain function but is often ignored in the sickest     patients including those in the intensive care unit after major surgery. In these patients,     the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain     that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test     whether improving sleep quality affects the risk of developing confusion (delirium) in     patients having clot removed from their lung (open heart surgery). In order to improve sleep     quality, the investigators will conduct a study of Ramelteon, a medication that mimics the     activity of melatonin and measure its effects on levels of melatonin and monitor sleep.   "
45429|NCT02691000|"     The Light-Heart study is a randomized, double-blind, controlled trial investigating the     effects of bright white light (BWL) therapy on depressive symptoms, quality of life, and     functioning in patients with Stage B heart failure. The study is a randomized, double-blind,     controlled trial of 8 weeks of morning BWL therapy compared with morning dim red light (DRL)     treatment in older (60 years or older) 122 Stage B (early, asymptomatic) HF patients.   "
45430|NCT02690987|"     The Gut Hormone in Addiction study is a proof-of-concept experimental medicine human study     to answer the following questions:        1. Does the administration of the hormone desacyl ghrelin reduce core behavioural          components of addiction in dependent individuals who have recently stopped smoking          tobacco or drinking alcohol, or overweight/obese subjects?        2. Does the administration of the drug Exenatide reduce core behavioural components of          addiction in dependent individuals who have recently stopped smoking tobacco or drinking          alcohol, or overweight/obese subjects?        3. Does the administration of desacyl ghrelin or Exenatide reduce reward responses to          high-calorie foods and appetite in dependent individuals who have recently stopped          smoking tobacco or drinking alcohol, or overweight/obese subjects?   "
45431|NCT02690974|"     The primary purpose of the study will be to describe the tolerability of treatment with the     optimal dose of LCZ696 (97.2 mg sacubitril / 102.8 mg valsartan bid), over six (6) months, in     patients with heart failure with reduced ejection fraction (HFrEF) in Canada.      The study will also describe the overall tolerability, effectiveness and safety of LCZ696 for     the management of HFrEF over 12 months of treatment, as well as describe the patterns of     LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.   "
45432|NCT02690961|"     The purpose of this study is to assess safety, tolerance and pharmacokinetics of     Multiple-dose Kukoamine B Mesilate in healthy volunteers   "
45433|NCT02690948|"     This phase 2 trial studies how well pembrolizumab with or without vismodegib works in     treating patients with skin basal cell cancer that has spread to other places in the body or     cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, blocks tumor     growth in different ways by targeting certain cells. Vismodegib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     pembrolizumab is more effective alone or together with vismodegib in treating skin basal cell     cancer.   "
45602|NCT02688725|"     Currently, there is no standard recommendation for using imaging studies to check patients     for breast cancer recurrence who have been treated with mastectomy. The investigator proposes     performing in-office ultrasound examinations of these patients to determine if this would be     helpful in identifying an expected 5-7% of patients with breast cancer recurrences following     mastectomy.   "
45434|NCT02690935|"     The primary objective of this study is to demonstrate the superiority of 2L®ALERG over     placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic     rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to     rescue medication intake. The secondary objectives are to compare the allergy symptoms, the     rescue medication intake, the quality of life and the safety in patients treated with     2L®ALERG or with a placebo.      This is a multicentre, randomized, double-blind, two-parallel group, interventional     placebo-controlled study with a notified homeopathic medication, marketed since 2002.      Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a     total of 100 patients included for 80 cases completed.      Screening will be done before the peak of pollination and the treatment will be set up two     months before traditional pollen peak, then visits at 3 months and 6 months, or end of the     peak.      The treatment will consist of 1 capsule daily, fasting morning, following the numerical order     of 1 to 10 capsules for 6 months.      The placebo will have the same form, colour, taste and aspect. The allowed concomitant     treatments are the already established treatments for associated pathologies not liable to     have an impact on the proper conduct of the study and the rescue medications allowed in the     first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye     cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those     above]).      The prohibited treatments are the oral or injectable corticosteroids and the     anti-leukotrienes.   "
45435|NCT02690922|"     The aim of our study is to improve the major molecular remission(MMR) rate and reduce the     cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and     the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy     drugs, lower the side effect brought by which this would be a grateful news for the patients     once this regimens gain a successful result, which is also the final aim of our efforts.   "
45436|NCT02690909|"     The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of     ablation features and technical improvements over previously designed systems into a single     product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of     the sympathetic nerve network surrounding the renal arteries.      This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal     Denervation device and to demonstrate that it performs according to its intended use, i.e.     the treatment of patients with uncontrolled hypertension.   "
45437|NCT02690896|"     The purpose of this study is to examine the effectiveness of support group intervention for     primary caregivers of a person with dementia or similar cognitive impairment.   "
45438|NCT02690883|"     This is a multi-center, randomized, parallel study to evaluate effect of exenatide on     24h-UAER in patients with diabetic nephropathy.      Screening will be made to select eligible participants before intervention. The trial will     include 2-week run-in period of stable doses of glargine plus lispro insulin and 24-week     treatment period. After the run-in period, patients were randomly assigned to one of two     groups for antihyperglycaemic therapies for a total of 24-weeks: glargine plus exenatide and     continued glargine plus lispro insulin. The treatment of exenatide will be initiated by 5ug     bid, and uptitrated to 10 ug bid after 4 weeks and then maintained at 10ug bid until the     completion of the study. Lispro insulin will be initially treated according to the insulin     dosage of previous antihyperglycaemic therapies, and further titrated up at 4-week intervals     until to reach the target fasting blood glucose (FPG).   "
45439|NCT02690870|"     The purpose of this prospective cohort study is to compare IVF outcome between tamoxifen and     clomiphene citrate in mild stimulation.   "
45440|NCT02690857|"     Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant     systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable     role in reducing redox status.      In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower     oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the     next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma     and platelet lipid compositions will be determined.   "
45441|NCT02690844|"     What affect does the use of a mucoadhesive drug delivery system (Mucolox®) compounded with     clonazepam have in the treatment of burning mouth syndrome?      There are no clinical trials reported in the literature that evaluate the use of a     mucoadhesive vehicle to deliver clonazepam into the oral cavity and treat burning mouth     syndrome. The use of a mucoadhesive may help to increase surface contact and elicit a greater     reduction in symptoms.   "
45442|NCT02690831|"     The aim of this study is to assess if an intervention of manual therapy and motor control     exercises combined with an inspiratory muscle training program is more effective than an     inspiratory muscle training program alone in increasing the maximum inspiratory pressure in     patients with asthma. In addition, the study pretends to evaluate the changes caused by the     intervention regarding possible postural changes and thoracic diameter.   "
45443|NCT02690818|"     The purpose of this pilot study is to determine whether regularly scheduled medication     reminder text messages (SMS) are effective in increasing latent tuberculosis infection (LTBI)     treatment completion.   "
45444|NCT02690805|"     The purpose of this research study is to investigate the accuracy of a breast imaging system     that measures the uptake of the injected radioactive tracer by gamma-ray imaging, known as     scinti-mammography (SMM), to diagnose the residual breast cancer after neoadjuvant     chemotherapy (NAC) treatment by comparing to MRI.   "
45475|NCT02690402|"     Older people are a very heterogeneous population characterized by a high interindividual     variability. Functional abilities (walking, transfers ...) used to classify individuals aged     (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS,     2005). Frailty is generally considered as a state that precedes dependent status and, unlike     the latter, is still reversible (Fried et al., 2001). Now, it's necessary to understand and     quantify the indicators above the dependence of the elderly from a multidisciplinary approach     to frailty, is a critical public health issue for developing non-drug therapeutic     interventions adapted to delay the institutionalization. Through this study, it is to     identify risk and protective factors of frailty and their relationships with physical     activity, evaluate them and propose an appropriate care to the patient. This study should     enable the production of new scientific knowledge to improve the health and quality of life     of older people.   "
45445|NCT02690792|"     One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity     and ~8 million of these individuals have a progressive form of the disease, non-alcoholic     steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which     individuals with NAFLD will develop NASH. This is of medical importance since NASH can be a     prelude to the development of end-stage liver disease.      The study of NAFLD has been limited by several factors, including the difficulties associated     with studying liver metabolism in vivo in humans. Our group has pioneered new methods that     use nuclear magnetic resonance (NMR) to measure intermediary hepatic metabolism in humans     with a goal of directly studying the pathophysiology of bland steatosis and NASH. In this     study, these noninvasive methods will be used to characterize and compare the metabolic     alterations that accompany bland steatosis and NASH and test the hypothesis that detects if     hepatic mitochondrial metabolism contribute to both disorders. Such characterization is     fundamental to establishing a rational approach to the prevention and treatment of NAFLD and     may provide simple, non-invasive methods to differentiate benign and progressive forms of     NAFLD.      This proposal will be addressed via separate isotopic studies occurring at different time     points during a prolonged fast. In subjects with NAFLD, these studies will be carried out     before and after treatment with Vitamin E or placebo.      Healthy subjects will participate in initial baseline studies only without Vitamin E or     placebo intervention.      The study is designed to harness the physiologic changes that occur with short- and long-term     fasting to provide a rapid and cost-effective method to accomplish the aims of the     application.   "
45446|NCT02690779|"     The study will consist of a prospective observational period performed in the GI Endoscopy     Lab. The objective is to document the quality of bowel preps in patients undergoing a     screening colonoscopy with and without an educational intervention.   "
45447|NCT02690766|"     Investigators proposed to refine and test the feasibility and acceptability of a 4-month     multi-modal lifestyle intervention in African American female breast or endometrial cancer     survivors diagnosed with type 2 diabetes.   "
45448|NCT02690753|"     The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors     are pressure or pressure combined with shear. Prevention is very important and comprises:     preventive skin care including cleansing and protecting the skin from exposure to moisture,     the systematic repositioning of the patient, the offloading of the heels from the surface of     the bed, the use of adequate bed support surfaces and an adequate nutritional status. The     development and implementation of a risk based prevention plan for individuals identified as     being at risk is strongly recommended. Limited compliance exists towards pressure ulcer     preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in     bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of     rigorously performed research addressing the effectiveness of devices or risk based protocols     to improve compliance. Health care budgets are limited, priorities should be set in the     allocation of health care resources.      The primary aim of this study is to compare the effectiveness of the turn and position system     (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition     frequence in patients at risk. The second aim is to compare the effectiveness of a tailored     protocol versus standard care to improve reposition frequence in patients at risk. The third     aim is to compare the effectiveness of standardized incontinence care versus standard care to     improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a     health economic evaluation will be performed.      The study will be performed in hospital setting (university and general hospitals) in a     random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers.     Patients will be recruited from three types of wards: intensive care units, geriatric wards     and rehabilitation wards. Patients will be included in the study for a period of 8 days.   "
45449|NCT02690740|"     The clinical relevance of an allergen-specific sensitization is proven e.g., by allergen     challenge tests in clinical routine. Several protocols for different challenge tests such as     nasal (NPT), bronchial (BPT) or conjunctival provocation test (CPT) have been proposed.     Beneath others, the CPT is broadly used in both clinical trials and routine because of its     feasibility.      However, there is no internationally harmonized standard regarding the clinical     interpretation of CPT results as well as a lack of validation of a specific outcome score.     Therefore, this trial aims to investigate and validate a new scoring system for CPT results     in order to provide this test as a useful method in future clinical trials.   "
45450|NCT02690727|"     This is a single centre, open label, randomized, two-treatment, two-period, two-sequence,     single dose crossover food effect study in 18 subjects. The subjects will receive the study     medication under either fed or fast during each treatment period.   "
45451|NCT02690714|"     This is a Phase 2/3 pivotal study of ProMetic Plasminogen (Human) Intravenous Lyophilized     solution.      The primary objective of the study is to achieve a consistent increase of individual trough     plasminogen activity levels.   "
45452|NCT02690701|"     This study will evaluate the effect of secukinumab compared to placebo on aortic vascular     inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly     controlled by current psoriasis treatments.   "
45453|NCT02690688|"     Dynamic preload variables like pulse-pressure and stroke volume variation may be used to     predict fluid responsiveness in patients during controlled ventilation. Previous work has     shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic     preload parameters, suggestive of a fluid deficit - despite fluid status had not changed [van     Lavieren M 2014].      The results of this study are limited by the fact that a non-invasive and uncalibrated     hemodynamic monitoring system (Nexfin™) was used.      The present study thus aims to evaluate the effects of abdominal pressure changes on dynamic     preload parameters (PPV and SVV) employing conventional, invasive hemodynamic monitoring     (Vigileo®, Edwards Lifescience) in open abdominal surgery as well as in minimal invasive     surgical procedures with pneumoperitoneum.   "
45454|NCT02690675|"     Objective: To evaluate the effect of Iron supplement with two different amounts (one in the     higher limit and another in the lower limit of the suggested amount) according to the     presence of mutations in the HFE gene in the physical, immune and neurobehavioral development     in the 6 to 12 moth toddlers.      Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital.     Methods: At 6 and 12 months it done clinical history, food registry, biochemist     determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune     response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D,     S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of     Infant Development 2on Edition: 1993). We evaluate the level of language and communication     (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and     environment surroundings (Scale Health General Parental Stress Index).   "
45455|NCT02690662|"     The objective of this study is to evaluate the influence of low-calorie diet on serum and     urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic     abnormalities.   "
45458|NCT02690623|"     Background. Hospitalists predominantly engaged in inpatient care constitute a fundamental,     poorly assessed change in medical care. The University of Texas Houston Pediatrics Department     is developing a Hospitalist Division to staff Children's Memorial Hermann Hospital.     Demonstration of its benefits and cost-effectiveness is important to secure adequate,     sustained hospital or 3rd-party reimbursement.      Design. Prospective step wedged quality improvement (QI) study with pediatric hospitalists     sequentially assuming 24/7 responsibility for each of the 4 pediatric inpatient services over     2-3 years. This design allows within- and between-group analyses and is particularly     desirable for evaluating interventions likely to be beneficial that will be given stepwise to     an increasing % of patients.      Intervention. Faculty of the new Pediatric Hospitalist Division will initially become     responsible 24/7 for 1-2 of the 4 services now staffed by the General Pediatric Division.     Currently, each pediatric service admits every other patient without regard to diagnosis,     resulting in quasi-random patient assignment.      Outcomes: Total hospital days (including 30-day readmissions); intubation; pediatric     intensive care unit (ICU) admissions; parent, nurse, and resident satisfaction; and costs     assessed using state-of-the-art methods and expressed from the health system, medical school,     and hospital perspectives.      Hypotheses. Hospitalists will improve clinical outcomes and parent, nurse, and resident     satisfaction and be cost-effective (primary outcome), assessed by net cost or savings per     hospital day prevented (health system perspective).      Analyses. Frequentist and Bayesian analyses to assess the probability of benefit and of     cost-effectiveness.   "
45459|NCT02690610|"     This prospective study will include 30 patients with hilar/mediastinal lymph nodes detected     by thoracic CT either there was a known lung malignancy (for staging purpose) or not (for     diagnosing purpose).      All patients will undergo to ROSE during EBUS-guided TBNA. Mediastinoscopy or other invasive     procedures will be performed if EBUS-guided TBNA doesn't provide representative material.   "
45460|NCT02690597|"     Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The     actual tools for evaluation of this specific part are complex and time consuming.      To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in     pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety     analogic visual scale by comparison with the actual reference the self-assessment     questionnaire State Trait Inventory Anxiety Y-A form.   "
45461|NCT02690584|"     The purpose of this open trial is to investigate the feasibility, acceptability, and effect     of metacognitive therapy in patients with prolonged post-concussive symptoms after mild     traumatic brain injury.   "
45462|NCT02690571|"     Air pollution is a global environmental and health concern, contributing to onset and     deterioration of respiratory and cardiovascular diseases. As climate change and dependence on     diminishing fossil fuel supplies have taken center stage in political and scientific debates,     renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common     biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a     green fuel, as it is sustainable and of biological origin, and therefore is often predicted     to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have     advantageous ecological impacts, consequences to respiratory health remained largely     unexplored.      The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel     exhaust would result in an acute airway inflammatory response in healthy human subjects, as     shown previously following exposure to petrodiesel exhaust.   "
45463|NCT02690558|"     The purpose of this study is to look at whether adding pembrolizumab (keytruda) to the     combination of gemcitabine and cisplatin will improve shrinkage of the tumor before having a     cystectomy, for people with muscle-invasive bladder cancer (MIBC).   "
45464|NCT02690545|"     The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancer. This research study combines two different ways of fighting disease:     antibodies and T cells. Antibodies are proteins that protect the body from disease caused by     bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which     stops them from growing and causing bad effects. T cells, also called T lymphocytes, are     special infection-fighting blood cells that can kill other cells, including tumor cells or     cells that are infected. Both antibodies and T cells have been used to treat patients with     cancers. They both have shown promise, but neither alone has been sufficient to cure most     patients. This study is designed to combine both T cells and antibodies to create a more     effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted     against the CD30 antigen (ATLCAR.CD30) administration.      In previous studies, it has been shown that a new gene can be put into T cells that will     increase their ability to recognize and kill cancer cells. The new gene that is put in the T     cells in this study makes an antibody called anti-CD30. This antibody sticks to lymphoma     cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies     have been used to treat people with lymphoma, but have not been strong enough to cure most     patients. For this study, the anti-CD30 antibody has been changed so that instead of floating     free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in     this way it is called a chimeric receptor. These CD30 chimeric (combination)     receptor-activated T cells seem to kill some of the tumor, but they do not last very long in     the body and so their chances of fighting the cancer are unknown.      The purpose of this research study is to establish a safe dose of ATLCAR.CD30 cells to infuse     after lymphodepleting chemotherapy and to estimate the number patients whose cancer does not     progress for two years after ATLCAR.CD30 administration. This study will also look at other     effects of ATLCAR.CD30 cells, including their effect on the patient's cancer.   "
45465|NCT02690532|"     This study will assess the effect of gluten on gut barrier function. Investigators at the     Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water     solution), and are hoping to prove its effectiveness in a clinical setting.   "
45466|NCT02690519|"     At least 6 cystic fibrosis patients with the S1251N mutation will be treated for 4 weeks,     consisting of two consecutive treatment periods of two weeks evaluating one dose of GLPG1837     each. After the treatment period, there is a 7-10 days follow-up period.      During the course of the study, subjects will be examined for any side effects that may occur     (safety and tolerability).      Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in     pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837     present in the blood (pharmacokinetics) will also be determined.   "
45467|NCT02690506|"     Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it     was reported that premedication of pregabalin before general anesthesia is effective to     reduce postoperative pain. Up to date, there is no study about the effect of premedication of     pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate the     effect of premedication of pregabalin on the spinal anesthesia.   "
45468|NCT02690493|"     The purpose of this study is to determine whether acupuncture and taping are effective in the     treatment of spastic upper limb after stroke.   "
46707|NCT02674269|"     The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release     of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.   "
45469|NCT02690480|"     This is an international, multicentre, double-blind, controlled, randomized phase II study     comparing the efficacy and safety of fulvestrant in combination with palbociclib versus     fulvestrant plus placebo in postmenopausal women with HR-positive/HER2-negative metastatic     breast cancer who have received ≥5 years of endocrine therapy in the adjuvant setting as     treatment for early disease and remained disease free for > 12 months following its     completion or have de novo metastatic disease. Patients must have at least one lesion     (measurable and/or non-measurable) that can be accurately assessed at baseline and is     suitable for repeated assessment by CT, MRI or plan x-ray. Patients with bone-only disease     must have a lytic or mixed (lytic + blastic) lesion, which has not been previously irradiated     and can be accurately assessed by CT/MRI or x-ray. Approximately 190 patients will be     randomized 1:1 between the experimental arm (approximately 95 patients treated with     fulvestrant plus palbociclib) and the control arm (approximately 95 patients treated with     fulvestrant plus placebo).      Primary Objective:      • To compare the efficacy of fulvestrant in combination with palbociclib versus fulvestrant     plus placebo in terms of the rate of Progression-Free Survival (PFS) at 1 year in     postmenopausal women with HR-positive/HER2-negative metastatic breast cancer previously     treated with endocrine therapy for at least 5 years and remaining disease free for more than     12 months following its completion or have de novo metastatic disease   "
45470|NCT02690467|"     The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm     needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in     patients with diabetes treated with insulin.   "
45471|NCT02690454|"     Ticagrelor is a direct-acting, reversible platelet P2Y12 receptor inhibitor recommended by     the recent European Society of Cardiology guidelines in patients with acute coronary     syndromes (ACS) (class of recommendation I, level of evidence B). Ticagrelor inhibits     platelet function stronger, faster and more consistently than clopidogrel, the former     standard of antiplatelet therapy. In the landmark PLATO trial (Study of PLATelet inhibition     and patient Outcomes), ticagrelor therapy as compared with clopidogrel treatment was     associated with the reduced occurrence of major adverse cardiovascular events and all-cause     mortality, but also resulted in a small, but statistically significant, increase in the rate     of major bleeding. The optimum choice of antiplatelet treatment, aimed to provide each     patient with maximum protection against ischemic events, while minimizing the risk of     bleeding complications, is the challenge of contemporary ACS therapy. The tool which may help     physicians and facilitate clinical decision making is platelet function testing. According to     the guidance of both European and American groups of experts, there are three currently     recommended platelet function tests, namely the VerifyNow device, the Multiplate analyzer and     the Vasodilator Stimulated Phosphoprotein Phosphorylation (VASP) assay. It needs to be     emphasized that none of these three methods is preferred over others. So far there are no     studies linking pharmacokinetic analysis of ticagrelor and its active metabolite with     comparative evaluation of platelet reactivity. The aim of this trial is to assess the     relationship between concentrations of ticagrelor and its active metabolite (AR-C124910XX)     and results of all three recommended platelet function tests in patients with myocardial     infarction. Patients who receive GP IIb/IIIa receptor inhibitor will be excluded from the     primary analysis.      Statistical analysis: The correlation will be assessed using correlation coefficients and     intraclass correlation coefficients. while the agreement between the results of the compared     platelet function tests will be measured using the Kappa statistic and Bland-Altman analysis.   "
45472|NCT02690441|"     Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is     highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for the     development of other severe conditions such as depression and dementia, and effective     treatments are called for. However, recommended treatment for GAD has consistently been found     to yield blunted response rates for older adults compared to younger patients.      The purpose of this study is to evaluate the effects of exercise-augmented cognitive     behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield     better results than standard CBT in terms of greater reduction of symptoms and increased     rates of remission. The investigators will also investigate the effects of treatment on     biological, physiological and neuropsychological measures.   "
45473|NCT02690428|"     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a     tumor specific immunologic response. In laboratory animals the imILT method has also been     shown to induce a so called abscopal effect. This means that when one tumor is treated with     imILT other, untreated, tumors also decrease in size. The immunologic response has previously     been characterized in breast cancer patients after receiving imILT treatment , and presumed     abscopal effects induced by imILT have also been described in a malignant melanoma patient.      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction     of the imILT treatment method in patients diagnosed with solid tumors. The purpose is also to     investigate the functionality and safety as well as understanding of the subsequent     immunological effects. Since immunologically based treatment of various solid tumors is under     intense review with so called immune checkpoint inhibitors this trial will also provide     valuable information on how imILT, in the future, could be combined with these new and, for     some patients, very effective treatment regimens.      The treatment method has successfully been used for treatment of patients with breast cancer     and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T     lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border.     Regulatory T lymphocytes decreased in the regional lymph nodes.      This trial is explorative, prospective, open and non-randomized. Thirty patients diagnosed     with solid tumors will be treated in this trial, which is estimated to be carried out during     a time period of 18 months.   "
45474|NCT02690415|"     Infections due to S. aureus are a major healthcare burden. Currently there is not an     effective way to prevent S. aureus infection. Treatment failure can happen in up to 20% of     patients with SSTI and mean additional cost per patient can be over $1500. Antibiotics are     often prescribed for the treatment of CA-S. aureus SSTI. Current IDSA CA-MRSA guidelines     suggest that incision and drainage alone may be adequate for management of uncomplicated     CA-S. aureus skin abscesses and there is uncertainty about the need of antibiotics. It is not     known whether antibiotics are helpful in decreasing S. aureus colonization rates or     preventing future S. aureus infections. Though resolution of acute abscess after drainage may     be unchanged by antibiotic administration, the impact of managing S. aureus abscess without     antibiotics on ongoing S. aureus colonization and recurrent infection requires further study.     This study seeks to examine whether the management of initial S. aureus abscesses with     incision and drainage in addition to antibiotic therapy is an effective means of preventing     recurrent infection. The prolonged longitudinal follow-up of this study is another unique     characteristic that will enable the investigators to capture data about recurrences of     infections.   "
45499|NCT02690077|"     The purpose of this study is to determine if patient birthing experiences differ between the     family-centered and traditional cesarean methods. We hypothesize that the family-centered     cesarean method will lead to more unique and personalized cesarean birthing experiences     without increasing the risks of adverse neonatal and maternal outcomes from those documented     with the traditional cesarean.   "
46651|NCT02674997|"     The purpose of this study is to investigate the feasibility and acceptability of the     Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported     outcome (PRO) measure to monitor clinical progress in participant-identified goal areas in     individuals with hemophilia A.   "
45476|NCT02690389|"     Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in     general anaesthesia through investigating the role of the Benzodiazepines-GABA system.      Method: 80 patients undergoing abdominal surgery were randomly divided into four groups     (n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group     (propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture +     flumazenil group). Before induction, acupuncture needles were inserted at the points of     Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicitDeQi. Target-controlled infusion     (TCI) of propofol was used for the induction and maintenance of anaesthesia. After 15minutes,     equilibrium of Narcotrend Index (NT index) was achieved, patients were then assigned to     receive different interventions. In EA group and EA+F group, patients received EA for 30     minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was added in     the latter at the end of EA. In C group and F group, patients didn't receive EA, and     flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time point     with EA+F group. HR, MAP and NT index were recorded at different time points up to 30 minutes     after the end of EA.   "
45477|NCT02690376|"     Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI     disorders. But it is uncomfortable for patients and incurs the risk of intubation and     sedation, plus a large proportion of procedures reveal insignificant or no pathology. Capsule     endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe,     non-invasive and well-tolerated. The use of CE is traditionally restricted to the small     bowel, although newer capsules to image the oesophagus and colon are currently in use.     Previous capsules have failed to adequately image the stomach due to its' large volume and     rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Mirocam     Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule.     This is unnecessary in the small bowel where the capsule is propelled along its' tubular     structure by peristalsis, but in the capacious stomach this may allow the capsule to be     steered to examine all areas of the stomach. We have already conducted two feasibility     studies in porcine models with promising results and a trial has already evaluated the     equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing     study is comparing the ability of this technique to examine the stomach against conventional     OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare     the two modalities under other different conditions.      We wish to undertake a prospective single blind controlled trial comparing magnetically     assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal     pathology in patients with gastrointestinal bleeding.   "
45478|NCT02690350|"     U3-1784 is a human monoclonal antibody specifically raised against the Fibroblast Growth     Factor Receptor 4 (FGFR4). The purpose of this study is to assess safety and tolerability of     U3-1784, an FGFR4 human monoclonal antibody, in advanced tumour and HCC patients. The study     is designed to identify a safe and tolerated dose in advanced tumour patients using a 3+3     dosing. The selected dose will then be used to assess safety and tolerability in HCC     patients.   "
45479|NCT02690337|"     This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of     DS-1123a in Japanese subjects with advanced solid tumors.   "
45480|NCT02690324|"     development of skin adhesive patches for the monitoring and prediction of mental disorders   "
45481|NCT02690311|"     Effects of Smartphone Use at Night with Light Emitting Diode Display With and Without Blue     Light in Healthy Adults: A Randomized, Double-blind, Cross-over, Placebo-controlled     Comparison   "
45482|NCT02690298|"     Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate     measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after     calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR     values measured by the ExSpiron™ without prior spirometer calibration to values obtained with     a spirometer calibration. In this study, the MV and TV values will be compared between the     ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a     spirometer   "
45483|NCT02690285|"     The purpose of this study is to identify and analyze the frequency of GSTZ1 haplotypes in a     healthy adult population and determine the pharmacokinetics of Dichloroacetate (DCA)     metabolism based on haplotype analysis.      The DCA drug is the first targeted treatment for Pyruvate Dehydrogenase Complex Deficiency     (PDCD).      This pilot study, focuses on developing a high throughput, sensitive and accurate screening     test for determining glutathione transferase zeta 1 (GSTZ1) haplotype status in individuals     who would be treated with DCA.   "
45484|NCT02690272|"     The kidney transplant remains the privileged treatment of the terminal renal insufficiency.     This care is complex for the patient both on a medical surgical plan and by the psychic     reorganizations. Among the temporary contraindications of transplantation, us retrouvonsdes     psychological reasons. The research work consists in highlighting the psychic mechanisms of     the subjects awaiting kidney transplant.   "
45500|NCT02690064|"     Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise     in patients with CF is related to greater death rates, steeper decline in lung function, and     more frequent lung infections. However, the physiological mechanisms for this reduced     exercise capacity are unknown. The investigators recently published the first evidence of     systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect     that the blood vessels are involved with exercise intolerance in CF. This study will look at     how and if oxidative stress contributes to both artery dysfunction and exercise intolerance     in CF.   "
45501|NCT02690051|"     A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the     treatment of Iliac Lesions.      The objective of this clinical investigation is to evaluate the long-term safety and efficacy     of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used     according to the indications of the IFU.   "
45603|NCT02688712|"     The purpose of this study is to see how effective and safe LY2157299, in combination with     chemotherapy and radiation therapy, might be in treating rectal cancer. Also as part of this     study, research will be done on tumor samples to see if it is possible to predict if patients     will respond to treatment, and blood samples to look at the immune system response to study     treatment.      About 50 people will take part in this study. The study treatment will be given over an 8     week period and the investigators will continue to collect your health information for up to     5 years, as part of this study   "
45485|NCT02690259|"     In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high     risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas     no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative     risk group allocation is known to be erroneous in up to 15% of patients.      A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential     to spare extensive surgery in 80% of high risk patients, identify low risk patients with     nodal metastases, diminish side effects caused by full lymphadenectomy and render some     expensive preoperative risk group allocation measures unnecessary.      A clinically useful SLN technique requires a high technical success rate, a clear definition     of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer     and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic     anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of     colored/ signaling nodes. Therefore, a definition of a SLN requires identification of     efferent/afferent lymph vessels.      Several publications describe sentinel node techniques in EC with a variety of tracers     (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as     radioactive nodes or colored nodes only with no further discrimination. No study relate     to an anatomical description of lymphatic pathways.      The aims of this study is to systematically display the major anatomical pathways with the     use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on     lymphatic anatomy and identification of efferent lymph vessels.   "
45486|NCT02690246|"     Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an     inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and     visceral arteriovenous malformations. The purpose of this study is to provide data about     multiple clinical aspects of HHT and responses to treatment. For comparison of some aspects     also data of non-affected relatives is collected (second cohort). the questionnaire has been     designed primarily for web based entry, but can also be circulated in paper format on     request.   "
45487|NCT02690233|"     This study on minor surgery serves to explore whether a dose-response relationship exists     between surgical stress and endothelial dysfunction in the early postoperative period. The     aim of this explorative and observational clinical study is to closely examine the     endothelial function and its dynamics in the early postoperative period after minor surgery     (lap. inguinal hernia repair). The endothelial function will be assessed indirectly by     EndoPat and plasma biomarkers of nitric oxide bioavailability. The study will contribute to     the understanding of perioperative myocardial injury, which is crucial for optimized     treatment of patients at risk of cardiovascular complications.   "
45488|NCT02690220|"     The purpose of this study is to determine the influence of anterior pelvic prolapse     reconstruction with a titanized polypropylene mesh on patients quality of life.   "
45489|NCT02690207|"     The purpose of this study is to cross-vaccinate and collect safety data in terms of     unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated     Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in     ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).   "
45490|NCT02690194|"     The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the     stress and anxiety levels of patients. The secondary aim is to investigate the effect of     prior stress and anxiety levels on the perceived pain level of undergoing a medical     procedure, reported post-procedure.   "
45491|NCT02690181|"     The objective of this extension study is the initial assessment of safety and immunogenicity     of the second dose of GBS Trivalent Vaccine following the time interval that is close to the     inter-pregnancy interval observed in the general population.   "
45492|NCT02690168|"     Hypoglycemia-associated autonomic failure (HAAF), a condition commonly developed in diabetic     patients, which causes them to have severely low blood sugar levels. This condition makes     clinical management of blood sugar in diabetic patients very challenging. This research seeks     to better understand how diabetic patients develop HAAF, and what can be done to prevent it.   "
45493|NCT02690155|"     To obtain a better understanding on the comparative effectiveness of rivaroxaban versus     VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial     fibrillation) in a real-life setting   "
45494|NCT02690142|"     The purpose of this first-in-human study is to investigate the safety and tolerability of     ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to     moderate-to-severe psoriasis patients.   "
45495|NCT02690129|"     The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the     treatment of threatened miscarriage. All eligible pregnant women will be randomized to either     receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention,     then every 4 weeks up to 28 weeks gestation or termination of pregnancy.   "
45496|NCT02690116|"     The purpose of this study is to test whether Meditative Movement (based on a standardized and     tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other     symptoms in women after treatment for breast cancer than (a) a non-meditative sham Qigong     active intervention and (b) an inactive education / support group.   "
45497|NCT02690103|"     Current treatments for Hepatitis C virus (HCV) have severe side effects and are very     expensive. There is a need to explore effective natural therapies against HCV that are less     toxic and more cost-effective.      37 chronic HCV infected patients were randomized into two groups and treated with PEG     interferon plus ribavirin for the first group or Biobran, an arabinoxylan from rice bran (1     g/day) for the second group. Viremia level, liver enzymes, γ-interferon (IFN-γ) levels in     serum, and toxicity were checked before and three months after treatment.   "
45498|NCT02690090|"     The investigators study is the first step (a pilot study) in determining whether the     manufacturer's recommended dose of a blood thinner called enoxaparin, in adults who are     patients in an intensive care unit and have severely reduced kidney function (less than or     equal to approximately 30% of their normal function) is safe with respect to the adverse     effect of bleeding.      The investigators hypothesis is that studying these patients, going forward in time, without     interfering with their care, to eventually determine if this blood thinner is safe at reduced     doses, is feasible.   "
45502|NCT02690038|"     This study will look at immunoglobulin (Ig) treatment in hospitalized chronic obstructive     lung disease (COPD) patients with frequent exacerbations.      This is a Phase II, pilot randomized double blind control study, meaning this study will help     assess if this research can be expanded to evaluate Ig treatment in patients with COPD. Ig     treatment is a sterile solution of human immunoglobulin proteins given intravenously (in the     vein). Immunoglobulins are part of the immune system and help the body fight infections.     Participants will be assigned to either receiving the Ig treatment or normal saline as a     control product every 4 weeks for 12 months.      Participants will continue on current standard therapy as determined by their treating     physician.   "
45503|NCT02690025|"     A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed     dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.   "
45504|NCT02690012|"     Hypomagnesemia (hMg) is a common side effect of important anti-cancer therapies such as     epidermal growth factor receptor inhibitors (EGFRIs) and platinum-containing anti-cancer     drugs. EGFRIs, including cetuximab (cmab) and panitumumab (pmab), have been estimated to     cause hMg in over 18% and 27% of patients respectively1, while 90% of patients receiving     cisplatin will develop hMg if left untreated. The development of severe hMg may result in     increased symptoms such as fatigue, neuromuscular changes, mental status changes and cardiac     arrhythmias which could result in treatment delays and may compromise treatment efficacy.     Despite the common occurrence of this toxicity, little is known regarding the optimal     magnesium management strategy. As physicians do not know what the best treatment for     patients is, genuine uncertainty (clinical equipoise) exists. Physicians will choose     between different standards of magnesium replacement in their personal practice, using     idiosyncratic decision making processes, without the physician or the patient knowing the     optimal option. This is not good for patients, physicians and society as a whole. Determining     the optimal treatment remains an important medical issue for patients, physicians and     society. This study will use a novel method to allow comparisons of established standard of     care prophylactic treatment using the integrated consent model as part of a pragmatic     clinical trial7. By integrating medical and clinical practices, physicians will be able to     inform their patients about the randomized control trial, akin to a typical conversation     between the physician and patient, without written informed consent. This clinical     interaction would then be documented, as ordinarily done in practice. Medical and clinical     practice will be intertwined with the patients' welfare at the forefront of our best     interests.   "
45505|NCT02689999|"     It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then     gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and     impedance kinetics.   "
45506|NCT02689986|"     Prospective, non-randomized multicenter study on the safety and efficacy of combination     therapy with bendamustine and rituximab for chronic cold agglutinin disease.   "
45507|NCT02689973|"     This longitudinal experimental study tested the effects of three brief interventions: (1)     prompting the formation of plans (or implementation intentions), (2) prompting self-efficacy     beliefs, and (3) prompting planning + self-efficacy in adolescents aged 14-18 years relative     to an active 'education only' control group.      It was hypothesized that participants assigned to the interventions would exhibit a smaller     increase in body fat at 14-month follow-up compared to controls. The study also investigated     whether the combined planning + self-efficacy intervention would have larger effects on the     main outcome (body fat) than single-component interventions. Second, it was hypothesized that     the effects of the intervention conditions on body fat at 14-month follow-up would be     mediated by their respective psychological and behavioral constructs: self-efficacy and     planning at T2 (Mediator 1), and by moderate-to-vigorous physical activity (MVPA) at T3     (Mediator 2). It was expected that the effects of the interventions including the planning     component (i.e., planning intervention and self-efficacy + planning intervention) would be     mediated by respective cognitions, i.e. planning, whereas the effects of the interventions     including self-efficacy component (i.e., self-efficacy intervention and self-efficacy +     planning intervention) would be mediated by self-efficacy. Finally, it was explored whether     the effects of the intervention (both direct and indirect effects, via their respective     psychological variables and MVPA) on body fat would be moderated by the presence of built PA     facilities, located in the proximity of schools.   "
45508|NCT02689960|"     Patients with chronic adrenal insufficiency need to adapt their glucocorticoid replacement     dose in conditions of physical or psychological stress to prevent life threatening adrenal     crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g.     gastroenteritis, severe infectious disease), rapid and highly dosed administration of     glucocorticoids is crucial. The study is conducted to offer female patients the possibility     to perform efficient prednisone self-administration in emergency situations in a way of     administration, which is easy to perform and accepted by the patients. Therefore,     pharmacokinetics and safety of vaginal prednisone administration will be studied and compared     to rectal administration.   "
45509|NCT02689947|"     Prospective single center study to evaluate the safety and effectiveness of Restylane Silk     for treatment of tear trough correction.   "
45511|NCT02689921|"     This is a prospective, single-arm, phase II study of 32 evaluable patients treated with     NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy     for hormone receptor positive (HR+), [i.e. Estrogen Receptor positive (ER+) and/or     Progesterone Receptor positive (PR+)] HER2+ localized, non-metastatic stage I - IIb breast     cancer.   "
45512|NCT02689908|"     The adjustment of radiation dose in many CT protocol are based on body mass index(BMI) or     weight of the patient.      In the literature, neck circumference (NC) has been reported as a new anthropometric     parameter indicating the body mass for the upper body.      NC may be an important landmark in the determination of the low dose protocols for upper body     CT examinations such as neck, chest and coronary CT.   "
45604|NCT02688699|"     The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in     preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD     (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon   "
45733|NCT02687022|"     Wavefront scans are a common form of diagnostic test applied in preparing patients for laser     eye surgery. An optical map of the eye is created by wavefront scanning, and information from     these maps is used to program lasers used to correct focusing errors in the eye. Here the     investigators are comparing how repeatable measurements are with a new wavefront scanner and     one that is already in widespread use.   "
45753|NCT02686762|"     This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects     with a diagnosis of definite NASH with fibrosis (excluding cirrhosis) as determined by the     central histopathologist. Upon successful screening, subjects will be randomized to receive     either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.   "
45513|NCT02689895|"     Highly active antiretroviral therapy (HAART) transformed a once fatal condition into a     chronic, manageable condition. However, it is estimated that 20-40% of patients on 2nd line     treatment (2 nucleotide reverse transcriptase inhibitors [NRTIs] and a boosted protease     inhibitor [PI]) are failing treatment. Figures are thought to be higher in children and     adolescents.      The reason why patients are failing 2nd line treatment is not exactly known. Failure has been     previously attributed to poor adherence. However, some literature shows that some patients on     boosted PIs achieve and maintain viral suppression despite suboptimal adherence (adherence of     80- 95%). Viral factors, like drug resistance, are also implicated in treatment failure.     However, boosted PIs have high genetic barrier to clinically significant mutations.     Therefore, a virus would have to harbour multiple PI mutations for the virus to have reduced     susceptibility to boosted PI regimens. Pharmacological factors such as suboptimal dosing,     impaired absorption and drug interactions may also be responsible for treatment failure.      If sub-optimal adherence is the reason why children are failing 2nd line treatment, then     restoring optimal adherence should result in viral suppression, failure of which might mean     that other causes are contributing to failure. If resistance is the cause of treatment     failure, then this study will provide evidence for advocating for resistance testing and the     use of 3rd line antiretroviral drugs. If children with adequate adherence demonstrate     inadequate drug levels in their plasma, then this study will provide evidence to advocate for     studies to examine reasons for inadequate drug exposure amongst HIV-infected children. These     studies are paramount to optimizing dosing algorithms in this population.      This proposed study will help elucidate reasons for treatment failure in HIV-infected     children on second line treatment with the aim of ultimately optimizing antiretroviral     treatment strategies for this important group.   "
45514|NCT02689882|"     Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®,     ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for     NR have not been reported in humans. This study will use a recently-developed, whole blood     assay for NR to assess the pharmacokinetics of NR at a maximum dose of 1000 mg twice daily,     and will collect history, physical examination and laboratory data to determine the safety     and tolerability of NR in eight, healthy volunteers. In addition, whole blood nicotinamide     adenine dinucleotide (NAD) levels will be measured at each time point, to determine whether     this NR dose significantly raises whole blood NAD levels.   "
45515|NCT02689869|"     Primary Objectives The primary objective of this study is to evaluate the efficacy of the     chemotherapy-free combination of ibrutinib and obinutuzumab (GA 101) in patients with     previously untreated follicular lymphoma (FL) and a high tumor burden. Primary endpoint to be     observed for this is the rate of progression free survival one year after start of therapy.      Hypothesis The hypothesis of the study is that ibrutinib in combination with obinutuzumab     will achieve response rates (CR and PR), rates of MRD negativity and PFS which are comparable     to currently used standard rituximab-chemotherapy combinations such as R-CHOP or     R-bendamustine in subjects with previously untreated FL and a high tumor burden.   "
45516|NCT02689856|"     The objectives of this study are to assess the potential contribution of lidocaine     hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream     preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and     efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I     or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride     or hydrocortisone acetate found in many prescription hemorrhoid products.   "
45517|NCT02689843|"     The aim of this study is to evaluate the effects of three-month course of treatment     modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with     polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine     and high sensitive C-reactive protein (hs-CRP)] levels.   "
45518|NCT02689830|"     The purpose of this study is to assess the feasibility and safety of Prostate Artery     Embolization (PAE) in patients suffering of Acute Urinary Retention (AUR) in the context     Benign Prostatic Hypertrophy (BPH).   "
45519|NCT02689817|"     Hospital-acquired pressure ulcers (HAPUs) are a well-established serious complication of     hospitalization that have serious consequences on patient morbidity and mortality as well as     the cost of care. At the core of the problem for patient-centered targeted prevention of     HAPUs is the lack of knowledge surrounding the magnitude and duration of pressure necessary     to cause pressure ulcers, and the lack of immediate feedback on whether these interventions     do anything to substantially offload at risk areas. Previous studies have been inconsistent     in their findings of an association between duration of time and HAPU occurrence. While     retrospectively this has been investigated, there is currently no substantial prospective,     randomized study.      This study seeks to better understand the interface pressures between the patient and his or     her support surface and how this relates to the development of pressure ulcers. The effect of     patient characteristics and the relationship between total length of time on the operating     table and pressure ulcer development will also be assessed.      The findings from this study will significantly add to strengthening the body of evidence     regarding pressure ulcer development, specifically the relationship between the magnitude of     interface pressure between the patient and the support surface for what duration of time     leads to the development of a pressure ulcer. The results will provide critical insight into     the physiologic targets healthcare providers should use to develop better pressure ulcer     prevention programs, which could ultimately lead to a reduction in the incidence of pressure     ulcers.   "
45520|NCT02689804|"     A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed     differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate     emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The     investigators propose a study to compare serum LNG and UPA levels after administration of a     single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no     difference in PK parameters between women with normal BMI and obese women.   "
45521|NCT02689791|"     A randomized, single-blind, cross-over study was conducted to determine the effect of     replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of appetite     and food intake in healthy adults.   "
45553|NCT02689362|"     This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel     treatment groups, with active control, will be performed in Brazilian study sites under the     sponsorship of Eurofarma Laboratórios S.A.. The enrollment for participants in the study will     start after the relevant ethical and regulatory approvals and will have an estimated duration     of 18 months.      One hundred and forty-four participants with T2DM according to the criteria of ADA who     consent to participation in the study by signing the Informed Consent Form (ICF) will be     enrolled in the study. In order to be enrolled, the patients must meet all the inclusion     criteria and none of the exclusion criteria. The eligible participants will be randomized     1:1:1:1 to receive evogliptin (EVO) at the doses of 2.5 mg/day (N = 36), 5.0 mg/day (N = 36)     or 10 mg/day (N = 36) or sitagliptin (SITA) at the dose of 100 mg/day (N = 36), as a single     daily dose, for 12 weeks.   "
45522|NCT02689778|"     It is estimated that approximately 30% of patients with diabetes develop diabetic     nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through     various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis,     control or blocking these mechanisms are therefore potential therapeutical targets for this     entity. Current treatment options are based on the glycemic control, blood pressure control,     as well as the use of medications such as angiotensin-converting enzyme inhibitors and     Angiotensin II receptor antagonists, these actions are not enough to stop progression.     Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties.     Although the specific mechanism is unknown, pirfenidone interferes with the expression,     secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan     to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients     with type 2 diabetes and nephropathy. The period of time the treatment will be administered     will be of 12 months, 62 patients will be included. The primary outcome will be improvement     in glomerular filtration rate. The secondary outcomes will be number of patients requiring     replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF -     β. Change in these parameters will be evaluated at the end of the treatment period (12     months). Throughout the study the incidence of adverse events will be recorded, wich will     allow us to learn about the safety and security of the drug in this population.   "
45523|NCT02689765|"     Metabolic problems represent one of the major health concerns which are attractive for being     addressed by nutritional interventions, as these are directly connected to dietary     habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes     alleviation properties, but association between anthocyans and prediabetes need to be more     firmly understood and established from robust clinical data. However, there is little human     research that has reported on the efficacy of increased anthocyans bioactive consumption on     insulin sensitivity in pre-diabetes.   "
45524|NCT02689752|"     This will be an open-label, single-center study to evaluate pharmacokinetics and safety of     HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of     HMPL-013 containing approximately 100 microcuries of [14C] HMPL-013. This study will     investigate the absorption, drug biotransformation and mass balance of HMPL-013, seek to     identify the compound's major metabolites and supply information for clinical application.   "
45525|NCT02689739|"     This is a prospective observational study comparing venous Doppler flow in the lower     extremities of pregnant women. Pregnant women with a BMI >/= 30 will be compared to those     with a BMI < 30.   "
45526|NCT02689726|"     A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of     GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged     25 to 65 Years, With Normal Cytology, ASCUS, or LSIL.   "
45527|NCT02689713|"     This study seeks to test if the study drug (voriconazole), when applied topically to a burn     wound on the skin will help to reduce pain.   "
45528|NCT02689700|"     The aim of the study is to determine the total concentration of HCMV- and VZV-specific     IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in     neonatal bloodstream depending on gestational age at birth.   "
45529|NCT02689687|"     This study offers remote monitoring devices for weight and medication adherence, combined     with behavioral economic approaches, to patients with congestive heart failure (CHF). This     pilot study aims to evaluate the feasibility of enrollment processes and intervention     roll-out to inform a randomized controlled trial, to estimate the readmission rate of     participants, and to assess if and how managing clinicians respond to weight gain alerts     entered into a participant's electronic medical record.   "
45530|NCT02689661|"     The primary purpose of this study is to discover modifiable risk factors for the development     of neuropathy, specifically looking at the metabolic syndrome.   "
45531|NCT02689648|"     Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is     largely unknown. The investigators plan to retrospectively analyse a cohort of children who     were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about     symptoms and effects of investigations performed. Furthermore, the investigators plan to     contact the cases for a follow up using a validated questionnaire and analyse the long term     prognosis and risk factors for prolonged severe symptoms.   "
45532|NCT02689635|"     Patients over 18 years of age, admitted to the hospital with HF exacerbation, will be     eligible for randomization to low salt or regular diet. Laboratory tests are routinely     obtained on admission and on the day (or the day before) of discharge (comprehensive     metabolic panel and NT-proBNP) and will be recorded for the study. Daily weights are     routinely recorded, and intake/output will be monitored. At discharge, a Diet Acceptability     Questionnaire will be performed.      After the discharge, participants will return for follow-up visits as needed for clinical     indications. Our study coordinator will document changes of symptoms, changes in therapies,     and capture clinical events like unscheduled hospital visits or visits to the Emergency Room.     Once during the study patients will be asked about their specific food consumption on a prior     day, and the Sodium content will be estimated. The final visit will occur in a year     (approximately 11-13 months after enrollment). Weight, other vital signs, CMP, BNP, and Diet     Acceptability Questionnaire quality of life questionnaire will be collected at this point, if     clinically indicated.      The majority of study information will be collected from routine care for standard clinical     indications. The only components added for study purpose are Diet Acceptability Questionnaire     and collection of the information on consumed foods.   "
45554|NCT02689349|"     The New Enrollment Post-Approval Study is designed to evaluate the long-term safety and     efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate     to severe hearing loss.   "
45605|NCT02688686|"     The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic     cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced     Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector     coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used     for DC-based immunotherapy. Based on the results of our previously preclinical study with DC     vaccine combined with CIK cells, the investigators plan to perform the clinical trial.   "
45533|NCT02689622|"     No prospective study was conducted in elderly patients with cancer to assess the relative     value of disease-related and patient-related prognosis factors. Patient-related prognostic     factors have been highlighted in elderly patients with cancer resulting in the necessity of a     geriatric assessment. The impact on overall survival of all of these factors was recognized     in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes     (HR-MDS). Therefore this information could be crucial to better select geriatric assessment     domains relevant for the prediction and to recommend simplified tool after stratification of     geriatric assessment domains thanks to their predictive value.      The main hypothesis is that patient-related factors will have a better capacity to predict     survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and     that the predictive value will be different among assessment tools which allows a selection     of reduced number of tools for clinical use.      To best knowledge estimation of predictive value of geriatric assessment tools remains     unknown and explains why no standardization of practice exists. In testing all tools at the     same cohort of patients allows to compare different tools and to define minimal and optimal     geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will     allow in a second time to measure the impact of the use of this geriatric standardized     evaluation by comparing patients'care and prognosis according to the use or not by the     doctors of the new scores.      Research outcomes are various medical, economic and ethic. Medical because decision-making     will be improved with simplified geriatric assessment; economic because a better knowledge of     geriatric assessment will improve treatment toxicity prevention and decrease treatment costs.     Ethic will be associated with this project because a better knowledge of geriatric assessment     tools to predict survival and tolerance treatment could improve the choice of best supportive     care if prognosis markers are not favorable to active therapy. This project could induce     important modification of practice in this area to an improved personalized treatment and     simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.   "
45534|NCT02689609|"     The investigators evaluate if there are radiation dosimetric parameters for the prediction of     biochemical and clinical hypothyroidism after intensity-modulated radiation therapy (IMRT)     for non-metastatic nasopharyngeal carcinoma (NPC).   "
45535|NCT02689596|"     The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to     resting state brain activity in healthy males.   "
45536|NCT02689583|"     Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out     with the goal of improving H. pylori eradication and therapies have changed from     single-antibiotic treatments to the current multi-antibiotic treatments. However, the     eradication rate of H. pylori is still less than 80%. The reasons for this low eradication     rate are likely to be multi-factorial, including the reduced activity of antimicrobial drugs,     poor patient compliance or micro-environment in stomach. In this study, to obtain the higher     eradication of H. pylori and discover the different mechanism between the current infection     and refractory infection of H. pylori, it is necessary to perform a prevalence survey for     eradication of H. pylori based on the results from isolation of H. pylori strains, antibiotic     susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and     16SrRNA sequencing.   "
45537|NCT02689570|"     Objective: To investigate whether visceral adipose tissue (VAT) and its adipokines contribute     to early signs of cardiovascular disease, meaning coronary artery calcifications (CAC) and     diastolic dysfunction in type 1 diabetes (T1DM).      Research Design & Methods: A cross-sectional study of T1DM patients without a history of     cardiovascular disease. CAC and VAT are measured using a CT scan. CAC is scored using the     Agatston method. Echocardiography is performed to assess contractile abnormalities. Serum     levels of adipocytokines (adiponectin, leptin, IL-6 and TNF-a) are measured using ELISA     assays.   "
45538|NCT02689557|"     Successfully develop and confirm with the Higher School of Electronics West Plethysmographic     a multichannel recorder to perform measurements staggered volume of the lower limbs at rest,     walking and recovery (6 storied measures on members lower).   "
45539|NCT02689544|"     The purpose of this study is analyze the effects, acute and chronic, static and dynamic     stretching on flexibility and neuromuscular and functional performance in active, healthy     individuals.      Study hypothesis:        1. Static stretching program improves flexibility and reduces neuromuscular and functional          performance in active, healthy individuals.        2. Static stretching program improves flexibility and neuromuscular and functional          performance in active, healthy individuals.   "
45540|NCT02689531|"     The purpose of this study is to better define the intensive care unit population at highest     risk for developing Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia     (HABP/VABP).   "
45541|NCT02689518|"     Clinical and genetic evaluation of individuals treated with intravitreal aflibercept     injection (Eylea) for neovascular age-related macular degeneration (wet AMD)   "
45542|NCT02689505|"     This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating     study of BI 836880 administered intravenously once a week. The eligible patient population     will be patients with advanced solid tumors.      The primary objective of this trial is to determine the maximum tolerated dose (MTD) and     recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety     data will be evaluated as secondary objectives.      Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and     Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the     immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid     tumors.      Dose escalation will be guided by a Bayesian logistic regression model with over dose control     (EWOC) using at least 2 patients per dose cohorts.      Safety criteria will be followed, including adverse events according to Common Terminology     Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination,     vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).   "
45543|NCT02689492|"     The present study will explore the patients satisfaction to COPD medical treatment (i.e.     pharmacological and not pharmacological treatment) in a clinical real-world setting and how     the satisfaction for medical treatment is related to clinical parameters, quality of life,     illness perception and treatment adherence evolution.      Moreover health care resource consumption will be observed during the observation period.   "
45544|NCT02689479|"     In people with type I diabetes, the insulin producing cells in the pancreas have been     destroyed. Presently one can only evaluate the function of the graft through laboratory     tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and     their location are not known. The possibility to study the mass of insulin producing cells is     of importance when developing new treatment regimes, in order to evaluate their efficacy on     this parameter.      The researchers in this study are aiming to develop methods to measure the mass of insulin     producing cells. A method (positron emission tomography, PET) previously used for the     diagnosis of tumors of insulin producing cells may also be used to measure the amount of     insulin producing cells in patients with type I diabetes. They plan to evaluate participants     with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be     used to measure the beta cell mass after islet transplantation.   "
45545|NCT02689466|"     Background:      Dystonia is a movement disorder in which a person s muscles contract on their own. This     causes different parts of the body to twist or turn. The cause of this movement is unknown.     Researchers think it may have to do with a chemical called acetylcholine. They want to learn     more about why acetylcholine in the brain doesn t work properly in people with dystonia.      Objective:      To better understand how certain parts of the brain take up acetylcholine in people with     dystonia.      Eligibility:      Adults at least 18 years old who have DYT1 dystonia or cervical dystonia.      Healthy adult volunteers.      Design:      Participants will be screened with a medical history, physical exam, and pregnancy test.      Study visit 1:      Participants will have a magnetic resonance imaging (MRI) scan of the brain. The MRI scanner     is a metal cylinder in a strong magnetic field that takes pictures of the brain. Participants     will lie on a table that slides in and out of the cylinder.      Study visit 2:      Participants will have a positron emission tomography (PET) scan. The PET scanner is shaped     like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A     small amount of a radioactive chemical that can be detected by the PET scanner will be given     through an IV line to measure how the brain takes up acetylcholine.   "
45546|NCT02689453|"     Background:      Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination     of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better     treatment for ATL.      Objectives:      To test if giving rhIL-15 combined with alemtuzumab improves the outcome of therapy for ATL.     Also, to determine the safe dose of this combination and identify side effects and effects on     the immune system.      Eligibility:      Adults 18 years and older with chronic or acute ATL who have not been helped by other     treatments.      Design:      Participants will be screened with tests that are mostly part of their usual cancer care.     They will sign a separate consent form for this.      Weeks 1 and 2: Participants will have a total of 10 visits. They will:        -  Get rhIL-15 under the skin by needle.        -  Have a physical exam and vital signs measured.        -  Give blood samples.        -  Answer questions about their health and their medicines.      Week 3: Participants will stay in the clinic. They will:        -  Get alemtuzumab infusions in a vein through a small catheter on days 1, 2, 3, and 5..        -  Take medicines to decrease side effects.        -  Have a computed tomography (CT) scan to evaluate the treatment.        -  Have a physical exam and vital signs measured.        -  Give blood samples.      Answer questions about their health and medicines.      Weeks 4, 5, and 6 will repeat week 3, without the CT scan. Some patients will just have     outpatient visits these weeks.      After treatment, participants will have follow-up visits every few months for up to 2 years.     At these visits, participants will give blood samples and have CT scans.   "
45547|NCT02689440|"     The goal of this clinical research study is to learn if giving half of the recommended FDA     approved dose of dasatinib can help to control CML as effectively as the full dose of     dasatinib.   "
45548|NCT02689427|"     The goal of this clinical research study is to learn if a combination of enzalutamide and     paclitaxel can help to control triple-negative breast cancer (TNBC) by shrinking the tumors     in the breast and/or lymph nodes before they are surgically removed. The safety of this     treatment combination will also be studied.   "
45549|NCT02689414|"     The purpose of this study is to evaluate the effect of preoperative remote ischaemic     preconditioning (RIPC) on organ damage and the functional characteristics of arteries in     patients undergoing vascular surgery. In addition, we investigate the connection between RIPC     and changes in the functional characteristics of arteries and low molecular weight     metabolites.   "
45550|NCT02689401|"     This research study is evaluating a new imaging method using MRI (magnetic resonance imaging)     to evaluate lymph nodes for evidence of tumor spread from esophageal cancer. This MRI study     involves an intravenous contrast called Ferumoxytol (FerahemeTM).   "
45551|NCT02689388|"     Post operative delirium is common after hip fracture surgery and is associated with increased     length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can     also decrease a patient's quality of life and increase treatment costs. Anesthesia and pain     relief (analgesia) treatments may also influence the incidence of delirium, but more research     is needed into which techniques are effective in improving patient outcomes, care and     decreasing costs. This pilot study compares the addition of regional analgesia as part of     general anesthesia to determine the incidence of delirium following hip surgery. This is a     collaborative study involving anesthesia, orthopedic surgery and geriatrics in the     improvement of patient care.   "
45552|NCT02689375|"     25 participants with back pain and no previous spinal surgery will be enrolled from a single     NHS site in England.      Participants will have already discussed spinal cord stimulation (SCS) pain management with     their consultant before being invited to participate. Participants will attend for 10 visits     over a period of 66 months. At visit one, study suitability screening and informed consent     will be conducted. Suitable participants will be booked to have SCS trial leads implanted and     an external programmable High Frequency battery trial box as a day case (Visit 2).     Participants will be contacted over the next 21 days to assess how the trial is progressing     and to book a follow up appointment in clinic to remove the trial leads (Visit 3) where a     treatment decision will be made. If a participant is determined as having had a successful     trial they will be listed and implanted with a full HF10 SCS implant (Visit 4). The     participants who proceed to a full HF10 SCS implant will be reviewed in the Clinic at 6, 12,     24, 36, 48 and 60 months post procedure. Their participation in this study will be no longer     than 66 months. A successful trial is defined as a reduction in pain by 30% on a Visual     Analogue Scale. Participants who do not obtain 30% reduction in 21 days is classed as a     failed trial and once the leads are removed will be reviewed in clinic by the investigator     for an alternative treatment plan (Visit 4). If a participant is determined a failed trial of     HF10, they will remain in the study with their consent for the full follow up schedule. The     follow-up for the failed trial cohort can be conducted via telephone to reduce the burden on     this trial group.   "
45606|NCT02688673|"     The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined     with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell     Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected     DC, which are used for DC-based immunotherapy. Based on the results of our previously     preclinical research with DC combined with CIK cells, the investigators plan to perform the     clinical trial.   "
45555|NCT02689336|"     This study proposes to treat patients with the combination of erlotinib and temozolomide.     Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors possess     a non-synonymous mutation in EGFR, ERBB2, or JAK2V617F (JAK2) will be eligible for the study.     Very few phase 2 clinical trials have been performed in pediatrics using targeted agents in     combination with conventional chemotherapy agents. Furthermore, since some combinations such     as the combination of this study (erlotinib and temozolomide) have shown additive/synergistic     effects in preclinical studies, therapy selecting for those patients who possess mutations     targeted by the TKI of the study, may unveil activity that has not been previously observed.     Thus, the investigators hope to determine whether the addition of additive/synergistic     chemotherapy will increase efficacy of target agent and/or increase tumor susceptibility to     targeted agent resulting in increased anti-tumor activity.   "
45556|NCT02689323|"     The purpose of this study is to investigate the modulatory effects of repetitive transcranial     magnetic stimulation (rTMS) on functional connectivity with the insula. Functional     connectivity (FC) measures the interaction between brain regions, and recent neuroimaging     studies have used FC to investigate how addiction affects FC among pertinent brain regions.     rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain     connectivity and could be used therapeutically to treat addiction. However, investigators     first need more information on brain FC and how it relates to behavior, in order to guide     rTMS target selection.   "
45557|NCT02689310|"     The investigators hypothesize that the use of leptospermum scoparium honey as a type of     dressing and/or debridement agent on stage III or IV pressure ulcers has an increased     efficacy and safety compared to the current treatment protocol that includes the use of     hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care.     Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a     treatment for Stage III and Stage IV pressure ulcers will not be inferior to the comparison     treatment of standard of care wound dressings. Moreover, this research design will enable the     research team to determine if the honey based dressings are equivalent to or superior to the     comparison treatment.      Therefore, the investigators specific study objectives are as follows:        1. Primary Objectives: Determine if the use of honey as an alternative treatment will          reduce site inflammation/irritation and pain associated with pressure ulcers compared to          the standard treatment options. Specifically, the investigators will monitor patient          PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue progression,          length of time to heal, patient pain assessments via the Wong Baker Face or Numeric          Scale, wound odors, and incidence of adverse events (measured by allergies, stinging          sensations, bacterial infections that warrant antibiotic intervention, etc.).        2. Secondary Objective: Patients in the honey treatment group will have lower costs per          healed ulcer than patients in the standard collagenase treatment group.   "
45558|NCT02689297|"     The purpose of the study is to evaluate the effect of various oral hygiene regimes on three     volatile sulfur compounds.   "
45559|NCT02689284|"     This main purpose of this clinical study is to learn about the safety and activity of     margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and     gastroesophageal junction cancer.   "
45560|NCT02689271|"     To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer     by better selecting patients who will benefit from diagnostic MRI and by improving the     performance of the mp-MRI itself   "
45561|NCT02689258|"     A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002     for Post-Operative Analgesia Following Abdominoplasty Surgery   "
45562|NCT02689245|"     Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre     cirrhotic,compensated,decompensated and reactivation). All the in and out patient with     Hepatitis B reactivation will be recruited and randomized into two arms.      Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).      Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.   "
45563|NCT02689232|"     All patients with non variceal bleed who are admitted under the Department of Hepatology at     Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide     informed consent.   "
45564|NCT02689219|"     This is a Phase II study to evaluate the activity of brentuximab vedotin in     relapsed/refractory non-seminomatous germ cell tumors (NSGCT).   "
45565|NCT02689206|"     GSK1278863 is an orally available, hypoxia-inducible factor - prolyl hydroxylase inhibitor,     currently being investigated as a treatment for anemia associated with chronic kidney     disease. GSK1278863 has been given as a once daily regimen in clinical studies to date.     However, physicians in countries that use a three-times weekly hemodialysis schedule prefer     to give the anemia medicine at the same time as the dialysis session. This study will test     how well GSK1278863 can maintain hemoglobin levels when given three-times weekly, for 29     days.      This study will describe the relationship between hemoglobin and GSK1278863 given three-times     weekly. The data from this study will allow for conversion of once daily doses to three-times     weekly doses.   "
45566|NCT02689193|"     The IDIS study aims to develop a new rapid diagnostic test for invasive salmonellosis using     samples (blood, urine) collected from patients with fever and healthy controls at the     Institute of Tropical Medicine (ITM) and collaborating centers. The samples are collected     after informed consent and/or assent is given by the participant and are stored in a -80 ⁰C     freezer after processing (centrifugation and/or aliquoting). Basic information regarding the     patient and the samples are coded and stored in a protected Microsoft Access database. The     samples will be shipped to Belgium for proteomic analysis. Identification of Salmonella     specific proteins in the samples will hopefully support the development of a rapid diagnostic     test. Once this test has been developed, the samples will also be used for validation and     evaluation of this test.   "
45567|NCT02689180|"     The ReBIC-1 trial was designed to evaluate the potential clinical risks and benefits of     withdrawing furosemide use in stable, apparently euvolemic, chronic HF outpatients in a     multicentric double-blinded randomized clinical trial.   "
45646|NCT02688153|"     The study purpose is to compare the EDWARDS INTUITY valve system with commercially available     stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with     coronary artery bypass.   "
45568|NCT02689167|"     Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in     accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be     offered participation in this study during the consultation as part of their usual care. The     patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is     initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks on      alternating with 2 weeks off       As soon as a dose or schedule adjustment is required, regardless of cause, the patient will     be randomised 1/1:        -  Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in          accordance with the Marketing Authorisation); 4 weeks on  alternating with 2 weeks          off         -  Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen          (investigational arm); 2 weeks on  alternating with 1 week off    "
45569|NCT02689154|"     The investigators will test a recent mobile technology based (mHealth) behavioral weight loss     intervention (W8Loss2Go), which is designed for children and adolescents, and uses an     addiction model to promote withdrawal from problem foods, snacking, and excessive amounts at     meals. The investigators will test whether this intervention will reduce body mass index     (BMI), help subjects identify and withdraw from problem foods, eliminate snacking, and     reduce the amounts of foods consumed at home meals.   "
45570|NCT02689141|"     A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of     a sequential regimen of bendamustine followed by ofatumumab and ibrutinib followed by     ibrutinib and ofatumumab maintenance in CLL patients.   "
45571|NCT02689128|"     Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and     anesthesia.      The aim of this study is to estimate the incidence and the risk factors of PONV at Jordan     University Hospital over one year period.   "
45572|NCT02689115|"     Rheumatoid arthritis (RA) is a systemic and auto-immune disorder whose primary characteristic     is the chronic inflammation of joints. The objective of this study was to evaluate whether     there was an association between the NF-KB1/IKK epsilon genetic expression and the clinical     activity in RA.      60 RA patients were included in the study, 30 with clinical activity and 30 with clinical     remission The NF-KB1/IKK epsilon genetic expression was performed by real time quantitative     Polymerase chain reaction (qPCR) through the Pfaffl method of relative quantification with     Taqman probes.   "
45573|NCT02689102|"     Often, assessing a classifying diagnosis in patients with interstitial lung disease provides     a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic     surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with     suspected ILD. However, tissue acquisition is associated with morbidity in these patients     with an already compromised pulmonary function. In clinical practice this results in the fact     that only a minor part of patients with an indication for tissue acquisition are actually     undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign     collected with minimal invasive novel optical techniques, to examine whether the addition of     novel optical techniques to the diagnostic process of ILD could potentially limit the need     for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by     providing additional information on biopsy location.   "
45574|NCT02689089|"     This phase IV clinical study trial will be conducted among persons who require treatment for     LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study     is to compare the proportion of people who complete directly observed prophylactic treatment     (DOPT) using the new 3HP regimen to the current standard of 9 months INH.   "
45575|NCT02689076|"     Among older VA patients who have Medicare coverage, 43% use both VA and non-VA     (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters,     treatments and test results provided in the other system. The overall objective of this     project is to examine the impact of VA provider notification of non-VA hospitalization or     emergency department (ED) visit using electronic health information exchange (HIE), along     with provision of post-hospital care coordination services. The investigators will examine     the impact of these approaches on preventing hospital readmission, increasing provider     follow-up, improving patient's self-knowledge, and preventing medication errors. The     investigators will also examine the effect of these approaches on VA and non-VA costs.     Finally the investigators will examine the acceptance of these approaches among VA and non-VA     providers. The study sample will consist of Veterans followed in geriatrics or primary care     clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will     monitor patients for non-VA hospital admission or ED visit using technology provided by     health information exchange organizations. Patients will be assigned to enhanced or control     treatment groups. For both groups the VA provider will receive an electronic notification of     a non-VA hospital admission or ED visit if it occurs. For the enhanced group, a care     transitions coordinator will deliver post-hospital coordination services during a home and/or     VA facility visit and follow-up phone calls over 1 month. The investigators' analyses will     compare effects of notification-plus-coordination versus notification-only on health care     outcomes. The investigators will conduct interviews with intervention team members, patients,     VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to     implementation of these approaches.   "
45576|NCT02689063|"     The purpose of the study is to determine the clinical efficacy and safety of Maxigesic IV,     acetaminophen IV, Ibuprofen IV versus placebo IV for the treatment of acute postoperative     pain after bunionectomy   "
45577|NCT02689050|"     EUS-FNA is the recommended diagnostic examination of choice when patients present with     suspected lower mediastinal lymph nodes on imaging. EUS-FNA is minimal invasive and low in     costs, and although it has a good record in detecting diseases (eg confirm a nodal metastasis     or granulomas) it has limitations in excluding diseases (missing metastases/ or granulomas)     resulting in a false negative rate of 15-20%. Substantial limitations that most likely can be     attributed to areas within the node that are not sampled during EUS-FNA tissue acquisition.     Improved needle based EBUS/ EUS guided nodal diagnostics might result in improved quality of     the fine needle aspirations, reduce in surgical diagnostic procedures , reduced costs and     result in a shorter timebefore-treatment interval.   "
45578|NCT02689037|"     Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on     prevention of events of stroke and death in patients with symptomatic intracranial     atherosclerosis (ICAS) is controversial.      Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in     preventing events of stroke and death in patients with symptomatic ICAS.      Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in     China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT     group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily)     immediately after randomization, and patients in PTAS+MT group will receive surgery within 5     days after randomization. The patients will be followed up for 1 year after randomization and     assessed for events of stroke and death at 30 days and 1 year after randomization, the     incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30     days and 1 year after randomization, incidence of in-stent restenosis at 1 year after     randomization,etc.   "
45579|NCT02689024|"     A broken hip occurs frequently in elderly patients and is often very painful. Side effects of     inadequately treated pain as well as the traditional drugs (administered through intravenous     catheter) used to treat pain are, among others, a confusional state, called delirium. When     pain medication is administered locally, only around the hip joint, pain might be treated     more effectively and these side effects could be prevented. This is called a nerve block.      The current study evaluates the use of a continuous nerve block throughout the complete     hospital admission with a catheter around the hip joint versus the use of traditionally used     pain medication administered though an intravenous catheter in elderly patients with a broken     hip. Half of all patients will receive the nerve block while in the emergency department and     the other half will receive pain medication through the intravenous access.   "
45580|NCT02689011|"     This study aims to compare the incidence of urinary retention and requirement of bladder     catheterization in patients undergoing total knee arthroplasty while receiving either     continuous epidural analgesia or single shot femoral nerve block.   "
45581|NCT02688998|"     In the REaCT-Vascular Access Her2 negative study, the investigator will use a novel method to     allow comparisons of established standard of care vascular access strategies using the     integrated consent model as part of a pragmatic clinical trial.      Determining the optimal vascular access strategy remains an important medical issue for     patients, nurses, physicians and society. A novel method to allow comparison of established     standards of care is needed as part of an increasing internationally mandated incentive to     perform more pragmatic clinic trials.   "
45582|NCT02688985|"     This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in     order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS     or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS     cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV)     infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single     600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to     receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of     ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4     [control group]) will not be a part of the randomization and will be recruited separately,     wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline.     PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by     14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the     start of the study before dosing with ocrelizumab and second LP at Week 52 following the     first dose of ocrelizumab.   "
45583|NCT02688972|"     Football is a sport with congested calendars, which requires muscle recovery strategies such     as cold water immersion (CWI). This recovery technique is well spread through football clubs,     although it lacks a profound physiologic investigation to understand its effects on athlete's     body. Objectives: The main objective of this study is to evaluate the effect of a long-term     CWI exposure in football athlete's.      Study Hypothesis:      H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph     signal, power and perceived of recover when compared with control sample.      H1: The application of Cold water immersion amends the biomarkers, electromyograph signal,     power and perceived of recover when compared with control sample.   "
45584|NCT02688959|"     The investigators will perform a feasibility/pilot trial of two non-pharmacological     interventions for ADHD in college students.   "
45585|NCT02688946|"     Rationale: The interaction between macro and microcirculation remains uncertain.     Microvascular alterations can occur when systemic hemodynamic parameters are within an     acceptable range. Perfusion changes and microvascular alterations may play an important role     in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery.     Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to     anastomosis creation. However, local oxygen delivery may still be compromised as little is     known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field     (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging     modality incorporated in a hand-held device, which illuminates an area of interest and     provides high contrast dynamic images of the microvasculature. DF-imaging enables to     visualize the bowel's microcirculation.      Objective: To describe the human gastrointestinal microcirculation during gastrointestinal     surgery under general anesthesia and to observe whether there is a correlation between bowel     microcirculation and systemic hemodynamic parameters.      Study design: A prospective, single center, observational, clinical, pilot study.      Study population: 70 patients undergoing elective, gastrointestinal surgery during which the     gastrointestinal tract is accessible for DF-imaging.      Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both     the serosal and mucosal side of the bowel during gastrointestinal surgery under general     anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular     Flow Index (MFI).      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The extend of burden and risk associated with participation is negligible. Using     DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is     described in the study procedure. Previous studies did not show any safety concerns.     Measuring will be performed under sterile conditions and the occurrence of tissue damage is     highly unlikely. Patients are under general anesthesia and will thus not experience any     inconvenience.   "
45586|NCT02688933|"     Primary Objective:      To demonstrate that morning injection of Toujeo compared to Lantus will provide better     glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult patients with type     1 diabetes mellitus.      Secondary Objective:      To demonstrate that treatment with Toujeo compared to Lantus will provide:        -  Lower incidence rate of nocturnal symptomatic hypoglycemia;        -  Better glucose control coverage during the last hours of CGM before next basal-insulin          dosing;        -  Less variability in CGM profile.   "
45587|NCT02688920|"     This observational study is conducted to determine how the duodenal layer thicknesses     (mucosa, submucosa, and muscularis) vary with several factors in patients with and without     type 2 diabetes.   "
45599|NCT02688764|"     This a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study     to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in     Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3     clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and     adolescent patients with CKD, and to provide safety and dosing information for this patient     population. The Phoslyra (comparator) group provides information for a descriptive comparison     of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).   "
45600|NCT02688751|"     A single site cross-sectional comparison of paired diagnostic imaging modalities.      This study will show the sensitivity and specificity of CEUS in detecting the various types     of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison     of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time     taken to perform the various types of scan, to allow healthcare costs to be calculated for     each imaging modality.   "
45588|NCT02688907|"     AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein     tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2     (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.      CDK1 (also called cell division cycle 2, or CDC2) activity drives a cell from the G2 phase of     the cell cycle into mitosis. In response to DNA damage, Wee1 inhibits CDK1 to prevent the     cell from dividing until the damaged DNA is repaired (G2 checkpoint arrest).      Inhibition of Wee1 is expected to release a tumor cell from chemotherapeutically-induced     arrest of cell replication. In vitro experiments demonstrate that AZD1775 has synergistic     cytotoxic effects when administered in combination with various DNA damaging agents that have     divergent mechanisms of action. Therefore, the primary objective of the clinical development     of AZD1775 is its use as a chemosensitizing drug in combination with a cytotoxic agent (or     combination of agents) for treatment of advanced solid tumors.      CDK2 activity drives a cell into, and through, S-phase of the cell cycle where the genome is     duplicated in preparation for cell division. Inhibition of Wee1 is expected to cause     aberrantly high CDK2 activity in S-phase cells which, in turn, leads to unstable DNA     replication structures and ultimately DNA damage. Therefore, it is anticipated that AZD1775     will have independent anti-tumor activity in the absence of added chemotherapy.      The tumor suppressor protein p53 regulates the G1 checkpoint. As the majority of human     cancers harbor abnormalities in this pathway they become more dependent on S- and G2- phase     checkpoints. Thus, S- and G2-checkpoint abrogation caused by inhibition of Wee1 may     selectively sensitize p53-deficient cells.      One hundred percent of SCLC has TP53 mutation, therefore we can expect that most of SCLC have     lost G1 checkpoint and has high probability of WEE1 dependency for proper DNA repair and cell     cycle progression. For this reason, SCLC could be a good clinical trial target disease for     WEE1 inhibitor.   "
45589|NCT02688894|"     This protocol is a molecular screening protocol only. No drug intervention study will be     included in this protocol. Based on the molecular profiling, patients may be eligible for     drug intervention study of SUKSES trial.      This procedure can be performed during or after the first-line treatment. DNA will be     extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring     CNV will be tested with DNA from tissue and/or blood.      Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.      Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring     CNV, immunohistochemistry and/or FISH.      Specific methods of each molecular tests will be defined with standard laboratory manual     developed by pathologists.   "
45590|NCT02688881|"     This study is a single arm, pilot study of sirolimus in patient with     Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway     aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar     scan that has progressed following standard therapy or that has not responded to standard     therapy or for which there is no standard therapy.      sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of     sirolimus in patient with Refractory solid tumor.   "
45591|NCT02688868|"     The purpose of this study is to evalute the clinical safety and effectiveness of released     specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.   "
45592|NCT02688855|"     The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or     females that have sustained a closed, unstable ankle fracture that requires surgical     treatment for stabilization. The initiation of the adjunctive treatment is to begin within 11     days of surgical stabilization.   "
45593|NCT02688842|"     The purpose of this study is to evalute the clinical safety and effectiveness of released     specification (38mm) of FirehawkTM Sirolimus target-eluting coronary stent system.   "
45594|NCT02688829|"     This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of     Microport for the first time to assess the preliminary safety and feasibility used in the     human body. And provide evidence for subsequent large-scale, multi-center, randomized     controlled clinical trials, then provide the basis for the formal application of the product     in China.   "
45595|NCT02688816|"     This study will compare the test performance characteristics of visual inspection with acetic     acid (VIA), Xpert HPV, and OncoE6 in HIV-infected women, to inform the possible inclusion of     these molecular tests in future cervical cancer screening   "
45596|NCT02688803|"     Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1%     expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over     express HER2.      TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and     have biologically more aggressive high grade disease. Clinically, patients with TNBC have a     poorer prognosis compared to patients diagnosed with other breast cancer subtypes. Because of     the aggressive phenotype and due to observations that systemic chemotherapy offers     significantly higher benefit in ER negative disease, current treatment guidelines from     provincial and other organizations recommend that patients receive adjuvant systemic     chemotherapy for any TNBC greater than 0.5 cm in greatest diameter or node positive     independent of primary tumor size.      Currently, there is no world-wide standard recommended chemotherapy regimen for the     management of TNBC in the neoadjuvant/adjuvant setting, with treatments varying from region     and institution.      As physicians do not know what the best treatment for patients is, genuine uncertainty     (clinical equipoise) exists. Physicians will choose between different standards in their     personal practice, using idiosyncratic decision making processes, without the physician or     the patient knowing the optimal option. This is not good for patients, physicians and society     as a whole. Determining the optimal treatment remains an important medical issue for     patients, physicians and society. This study will survey opinions on a novel method to allow     comparisons of established standard of care prophylactic treatment using the integrated     consent model as part of a pragmatic clinical trial and attempt to compare head to head     standard chemotherapy regimens in patients with TNBC.   "
45597|NCT02688790|"     The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single     intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of     a single dalbavancin IV infusion.   "
45598|NCT02688777|"     Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an     estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88     million for follow-up care over 6 months post-stroke. Contributing to these costs is the     incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to     an increased incidence of fractures, depression, and mortality. New strategies are needed to     help Veterans post-stroke regain their ability to safely walk without increasing their risk     of falling as well as readily identify those who are a fall risk. This study addresses both     of these needs as it will 1) investigate a new treatment approach, backward walking training,     to determine if it will decrease fall incidence in the first year post-stroke and 2)     determine if backward walking speed early after a stroke can identify those that are at risk     for future falls.   "
45607|NCT02688660|"     Traumatic brain injury (TBI) is the leading cause of death or disability in children. Each     year in the United States, pediatric TBI results in an estimated 630,000 emergency room     visits, 58,900 hospitalizations, and 7000 deaths. The incidence of long-term disability after     severe TBI is high, with over 60% of children requiring educational or community based     supportive services 12 months post-injury. Over 5,000 children require inpatient     rehabilitation after TBI each year and an estimated 145,000 US children are currently living     with disabilities after a severe TBI. Hospital costs for the acute treatment of children with     TBI are estimated at ~$2.6 billion each year, while the gross annual costs accounting for     long-term care and lost productivity approach $60 billion. Therefore, pediatric TBI is a     major public health concern and new ways to diagnose and treat TBI are urgently needed.   "
45608|NCT02688647|"     This study is being conducted to evaluate the safety, tolerability, and activity of 400 mg of     KD025 once-daily (QD) compared to standard of care (SOC) in male and     postmenopausal/surgically sterilized female subjects with IPF.   "
45609|NCT02688634|"     Cleft Lip and Palate surgical repair is one of the most common procedures performed by     Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no     consensus exists regarding the usage of postoperative antibiotics or the effects this might     have on wound complications such as cellulitis, dehiscence, or fistula formation. The     surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological     organisms, indeed the human bite is one of the more clinically and microbiologically     significant injuries to treat. This research study is to elucidate the role, if any, that     prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and     VPI repair and potentially establish a new paradigm of care.   "
45610|NCT02688621|"     The investigators propose a randomized controlled trial to evaluate whether the addition of     financial incentives to a high-quality, online behavioral weight loss intervention produces     better weight losses than the online treatment alone.   "
45611|NCT02688608|"     This study is being done because there are currently no approved and no commonly working     targeted therapies in anaplastic thyroid cancer (ATC). This is an area of urgent need for     patients, not just for approved treatments but also rationally-designed clinical trials     designed specifically for ATC. Patients diagnosed with anaplastic thyroid cancer have a very     high likelihood of dying because of their disease. As such there is a clear need for     improving therapy for ATC.   "
45612|NCT02688595|"     The purpose of this study is to compare the differences in central venous catheter insertion     time, success rate, and complication between the Seldinger and modified Seldinger technique     for ultrasound-guided central venous catheterization in neonates.   "
45613|NCT02688582|"     For this study, a previously developed population pharmacokinetic (popPK) model for cefepime     (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software     program to drive an infusion pump. By entering patient data (such as gender, serum     creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and     given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of     this study is to prospectively validate the popPK model using TCI.   "
45614|NCT02688569|"     This randomized controlled clinical trial will examine the effects of Cognitive Behavioral     Therapy (CBT-) in patients with comorbid chronic widespread pain (CWP) and insomnia.      Specific Aims:        1. To examine the clinical and health characteristics, including sleep, pain, fatigue,          cognitive abilities, and cardiovascular health in patients with comorbid CWP and          insomnia.        2. To examine changes in the primary clinical outcomes, including chronic pain, complaints          of poor sleep, and fatigue compared to the waitlist control (WLC).        3. To examine changes in the secondary clinical outcomes, including mood, daytime          functioning, cognitive functioning, and cardiovascular health compared WLC.        4. To examine the mechanistic variables, including arousal (heart rate variability, HRV),          CS (thermal response) and neural plasticity (brain function and structure) - compared to          WLC.   "
45615|NCT02688556|"     This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of     OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis     sicca to be conducted at approximately 50 sites.   "
45616|NCT02688543|"     Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be     inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a     solution, but waiting lists may be long or certain patients may not be apt for a surgical     intervention. Therefore an alternative pain treatment that is effective and has little side     effects allowing to offer pain relief to those difficult to manage patients would be an added     value in the therapeutic options.      We studies the short and long-term effects of radio frequency treatment of the genicular     nerves in patients with severe pain due to osteoarthritis of the knee.   "
45617|NCT02688530|"     For surgery involving the shoulder, anesthesiologists will often inject local anesthetic     numbing medication near nerves supplying the shoulder in what is called a supraclavicular     nerve block. These nerve blocks cause numbness and weakness in the shoulder leading to     relaxation of the joint which is helpful to the surgeon and allowing for painless surgery     without general anesthesia. After surgery, pain relief is sustained for the duration of the     nerve block.      The primary purpose of this study is to clarify the duration of pain control provided by     supraclavicular blocks when supplemented with varying doses of the steroid anti-inflammatory     dexamethasone when given through the intravenous line (IV). IV dexamethasone is commonly used     for both nausea prevention and block prolongation, but a detailed study of the effect of     varying doses of this medication on duration of pain relief and weakness from the block has     not been studied. The study investigators seek to identify what association, if any, is noted     between IV dexamethasone doses and changes in blood glucose levels after shoulder surgery     with regional anesthesia and sedation. Finally, the study investigators will collect data on     side-effects and postoperative complications, if any, in patients receiving a range of doses     of IV dexamethasone.   "
45618|NCT02688517|"     This research trial studies the use of targeted genomic analysis of blood and tissue samples     from patients with cancer. Genomic sequencing is a laboratory method that is used to     determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing     can be used to find changes in areas of the genome that may be important in the development     of cancer. It may also help doctors improve ways to diagnose and treat patients with rare     cancers with poor prognosis or lack of effective therapy.   "
45619|NCT02688504|"     In France, drugs affecting driving ability directly or by indicating at-risk diseases are     classified in a 4-level standardized classification associated with a graded pictogram.      When the French authorities required this graded pictogram, they commissioned the CESIR-U1     study, a study designed to describe the use of labelled medicines by drivers involved in     serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges     and Toulouse, recruited 679 drivers involved in serious road accidents. When the     responsibility of the driver is taken into account, it appears that the association of risk     factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility.     Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did     not reach significance.      This conclusion is different from the conclusion of CESIR-A, a data linkage study of the     police and the health insurance databases which showed a correlation between the use of grade     2 or 3 labelled medicines and driver responsibility.      This difference between CESIR-U and CESIR-A could be related to a lack of power or to the     characteristics of the subjects included (mostly young men and motorcycle drivers). That is     why it was thought interesting to increase the size of the sample and to include non serious     road accidents (hospitalization < 24 hours) that represent around 73% of accidents.   "
45620|NCT02688491|"     Whether patients with stage III clear cell renal cell carcinoma(ccRCC) should receive     adjuvant targeted therapy or not is still on debate. The investigators invented a assay     consisting of 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000     （EHBP1L1）and cg14391855（RIN1）that was successfully categorise patients with stage III clear     cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93.     Here the investigators randomly assign assay-defined high risk patients of locally advanced     ccRCC into adjuvant targeted therapy group and observation group.Disease free survival and     overall survival are the end points of observation.   "
45621|NCT02688478|"     Phthalates are commonly used plasticizers that have been linked to asthma in epidemiological     studies. The investigators are researching effects of phthalates on airway immunology and     lung function, and on allergic responses by doing an inhaled allergen challenge. After     exposing participants to either filtered air or carefully controlled levels of phthalate in     our exposure chamber we will collect samples from the nose and the upper airways, by rinsing     the nose with saltwater or performing small brushings. The investigators will also collect a     bronchial samples by bronchoscopy after each exposure. After 2 weeks, the entire procedure     will be repeated with the alternate exposure.   "
45622|NCT02688465|"     Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms     that complicate and impair patients' quality of life. Among those disorders are sleep     disorders.      Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long     periods of awakening which occupy 30 to 40% of their night.      Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the     study is to assess changes in the quality of sleep in Parkinson's disease patients treated     with an apomorphine pump.   "
45623|NCT02688452|"     The primary purpose of this interventional, placebo controlled, crossover, double blind,     basic science exploratory study is to investigate whether there is a difference in brain     electrophysiological oscillatory activity in healthy adults before and after oral consumption     of water containing very small bubbles of oxygen (electrokinetically modified water).   "
45624|NCT02688439|"     The primary purpose of this study is to determine whether the leg positioning or distal     tourniquet used during the injection of local anesthetic may decrease the onset time and     prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with     popliteal approach. Patients will be divided randomly into three groups: group 1 will receive     sciatic nerve block, with leg kept in a neutral position after anesthesia (control group);     group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot     over a support placed on the OR table and maintained in that position for 15 min; and     patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the     lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle)     with the leg in a neutral position   "
45625|NCT02688426|"     The low-level laser therapy (LLLT) has been used in many inflammatory disorders.      More recently the LLLT was associated with an improvement in the muscle strength, endurance     and functional capacity.But, these effects were described only in health or athletic     individuals. In this randomized and controlled clinical trails, the investigators will study     the effects of LLLT on functional capacity of the patients with Coronary artery bypass     surgery.   "
45626|NCT02688413|"     Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality     based system for upper limb motor rehabilitation in early post-stroke patients. The study     aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose.     Effectiveness will be evaluated by validated rehabilitation performance scales.     Cost-effectiveness will be assessed by the resource utilization.   "
45627|NCT02688400|"     Osteoarthritis (OA) of the knee is the most frequent cause of knee pain after the age of 50     years. OA is a joint disease characterised by articular cartilage loss associated with     structural changes in the cartilage and adjacent structures. The main symptoms are pain and     functional disability. The goals of OA therapy are to decrease pain and maintain or improve     joint function. There is evidence that diacerein has both a symptomatic and a structural     effect on cartilage, and clinical studies suggest that diacerein therapy significantly     decreases OA symptoms when compared to placebo. Diacerein has been shown to inhibit     interleukine-1 (IL-1β), and down-regulated IL-1β stimulated secretion of metalloproteinases     and aggrecanases, and thereby prevent breakdown of cartilage by these enzymes. Diacerein has     no effect on the synthesis of prostaglandins, and therefore no effect on the upper intestinal     tract. The purpose of this phase III-IV international, multicentre, double-blind,     non-inferiority, randomised, controlled study is to determine the efficacy and safety of     diacerein vs. celecoxib on symptoms after 6 months of treatment, and on structural changes     after 2 years of treatment in knee OA patients as assessed by magnetic resonance imaging     (MRI).   "
45671|NCT02687828|"     This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal     Behcet's disease (BD) patients in routine clinical practice.   "
45628|NCT02688387|"     This study is designed to understand the relative bioavailability (proportion of the     administered dose that is absorbed into the bloodstream) of several fixed dose combinations     (FDCs) tablets of ambrisentan and tadalafil for further development and to provide     pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence     (BE - the relationship between two preparations of the same drug in the same dosage form that     have a similar bioavailability) study. Depending on formulation work, the study will allow up     to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies.     The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE     study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted     state. This is a single centre, Phase 1, single dose, randomised, open label crossover study     with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects.     Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg]     + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently     (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are     identified in this part of the study, then they will be re-formulated and tested in part 2.     If no successful formulations are identified in part 1 of the study, then part 2 will be     utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less,     are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess     food effect and part 3 will not be required. If successful formulations are identified in     this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not     already assessed in this part. Therefore, part 3 is optional and utility is dependent on the     results of the previous study parts.   "
45629|NCT02688374|"     This is a randomized, open-label, single-dose, three-period, crossover, single-center     comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult     participants with a history of cigarette smoking. The participants will be admitted to the     investigational clinic at least 38 hours before dosing and will remain domiciled until the     completion of all study procedures at approximately 24 hours after dosing. Three toothpastes     (one is commercial non-medicated non-nicotine containing chewing gum and other two are     nicotine containing gums) will be provided across the 3 treatment periods. During each of the     3 treatment periods, participants will be under supervision in a non-smoking area and will     abstain from smoking.There will be a total of at least 7 days and not more than 10 days     (clinical furlough period) between treatment periods. Twenty (20) blood samples will be     collected for pharmacokinetic (PK) analysis at baseline and multiple time points following     study drug administration. The trial duration will be approximately 49 days and up to 55 days     from screening to study end including the screening period.   "
45630|NCT02688361|"     This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover     design study in adult male and female healthy participants. Eligible participants will     receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N-     acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral solution,     200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48 hours in     each period. After completion of the second study period (i.e. last pharmacokinetic (PK)     sample on Day 3 of Period 2) participants will be discharged from the clinic.   "
45631|NCT02688348|"     This research trial studies quality of life after bladder-preservation chemotherapy and     radiation therapy (chemo-radiotherapy) in patients with bladder cancer that has spread into     or through the muscle layer of the bladder (muscle-invasive bladder cancer).     Bladder-preservation chemo-radiotherapy is a standard treatment for patients with     muscle-invasive bladder cancer, however, chemo-radiotherapy may cause urinary tract, bowel,     and sexual late side effects that negatively affect patients' quality of life. Studying     quality-of-life in patients with muscle-invasive bladder cancer after chemo-radiotherapy may     help identify the long-term side effects of treatment and may help plan the best treatment in     the future and improve patients' quality of life.   "
45632|NCT02688335|"     This is an interventional study in which patients with a history of habitual snoring will use     the low-pressure CPAP device at home for about 2 weeks. This study is designed to document     the adherence of the snorer, the acceptance and comfort of the therapy, and bed partners'     subjective report of improvement in sleep quality, and/or reduction or elimination of     snoring. Study outcomes will consist of an assessment of the nightly usage time, and     questionnaires that the snorer and the bed-partner have to complete before the start of the     study, after two night's treatment, and at the end of the study period.   "
45633|NCT02688322|"     Acinetobacter species have emerged as agents of serious nosocomial infections in critically     ill patients. Only a few effective antibiotics are currently available for the treatment of     this pathogen and, therefore, sulbactam is being considered as an alternative treatment     option. The aims of this study were to i) reveal the population pharmacokinetics and ii)     assess the probability of target attainment (PTA) of sulbactam in septic critically ill     patients caused by Acinetobacter spp. infections.      The study was conducted in septic critically ill patients caused by Acinetobacter spp. Each     patient received 2 g every 12 h of sulbactam for 10 days, after which PK studies were carried     out on day 4 of sulbactam therapy and a Monte Carlo simulation was performed to determine the     probability of attaining a specific pharmacodynamic target.   "
45634|NCT02688309|"     This study will examine potential factors in the aqueous humor that may contribute to the     development or progression of macular edema or fibrosis (due to any underlying disease) in     patients suffering from these conditions.   "
45635|NCT02688296|"     The objective of this post-market clinical study is to evaluate efficacy outcomes and     complication rates in patients who have received the Fibulock™ Intramedullary Nail.   "
45636|NCT02688283|"     The objective of this trial is to compare a snack with ingredients (whole grains and dietary     fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and     evaluate the effect of the snack on glycemic response and subjective satiety. The test     product will be compared with a control product as well as white bread in a randomized,     controlled, crossover trial including 20 healthy males or females between the ages of 18 and     70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast,     participants will be given each of the study products in a random order at least a week     apart. Glucose and insulin will be measured before product consumption and over a period of     four hours. Visual analog scales to measure subjective satiety will also be administered over     a period of four hours.   "
45637|NCT02688270|"     The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical     cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon.     The symptoms of this disease include pain, tingling, and numbness in the fingers of the     affected hand or hands.   "
45672|NCT02687815|"     This study will determine whether vitamin D3 prevents severe asthma attacks in children who     have a serum vitamin D (25(OH)D) level <30 ng/ml and who are being treated with inhaled     corticosteroids for asthma. Half the participants will receive vitamin D3 at a dose of 4,000     IU/day, and the other half will receive placebo.   "
45638|NCT02688257|"     Patients with large primary operable breast cancers are offered chemotherapy prior to surgery     to shrink the tumour and enable breast conserving surgery. Conventional assessment of     response to chemotherapy relies on a change in tumour size which does not always correlate     with the change in amount of viable tumour. Newer techniques such as functional MRI,     microbubble and optoacoustic ultrasound offer the potential to detect responses to     chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither     modality utilises ionising radiation.      Although MRI is widely used for detecting breast cancer, its ability in assessing functional     responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast     enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of     blood volume and flow. Other functional techniques detect variation in tissue oxygenation:     this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a     special magnetic resonance (MR) sequence called T2* to measure the weakly magnetic effect of     deoxygenated haemoglobin. The investigators wish to develop and validate T2* measurements     which relate to oxygenation of a tumour. The investigators also want to validate other MR     sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood     in the capillary network and the diffusion of water within tissues.      Microbubble ultrasound is an established technique that utilises an intravenous contrast     agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and     enhance spectral and colour Doppler signals obtained from routine ultrasound imaging.     Optoacoustic imaging is new technique where the output signal depends on the oxygenation of     the tissues under study. It utilises a light signal input and measures ultrasound signal     output.      The investigators want to correlate our imaging findings with histopathology after surgical     resection of the tumour.   "
45639|NCT02688244|"     This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in     complicated acute appendicitis performing irrigation of the abdominal cavity or only suction     without lavage.   "
45640|NCT02688231|"     An adequate upper limb function is crucial to independently perform Activities of Daily     Living (ADL). Persons with neurological diseases often experience upper limb dysfunction.     Upper limb function in Multiple Sclerosis (MS) is highly prevalent, increasing with overall     disability level, while the detrimental impact on ADL is higher than in stroke, given that     symptoms often occur bilaterally. In contrast to stroke, it is unknown whether similar     rehabilitation principles and effect sizes apply in MS given that this progressive     neurodegenerative disease is characterized by multiple lesions and atrophy of brain     structures. To date, optimal therapy dosage of upper limb rehabilitation programs are not     known in the MS literature neither were characteristics of responders identified.      The aim of this explorative study is to investigate the intensity dependent clinical effects     of a task-oriented upper limb training in persons with MS with different upper limb     disability levels.   "
45641|NCT02688218|"     The risk of hypoglycemia in individuals with type 1 diabetes increases considerably during     exercise. As a result, many patients with type 1 diabetes experience fear of and reluctance     to pursue physical activity, in order to avoid the discomforting symptoms associated with     hypoglycemia. The bi-hormonal artificial pancreas, a device used for automatic delivery of     insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to     revolutionize the management of this disease. The investigator's group has recently completed     a study of the bi-hormonal artificial pancreas system during exercise, suggesting reduced     hypoglycemia around the exercise period. In order to prepare for a future home study, the     ability to detect, grade, and classify physical activity so as to appropriately adjust system     parameters is vital in helping to prevent exercise induced hypoglycemia in the home setting.      This study is designed to collect 3-axis accelerometry data and heart rate data during a     variety of different home activities, as well as during formal exercise in both healthy     subjects and subjects with type 1 diabetes. Additionally, the investigators will observe the     change in glucose levels before and after exercise in subjects with type 1 diabetes.   "
45642|NCT02688205|"     Shoulder problems cause substantial disability in daily living, work, leisure activity, and     exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly     predictive of impaired health-related quality of life.      Many tests were used for physical examination of the shoulder. The reliability and validity     of the tests have been studied before. However, a systemic review concluded that there was     conflicting evidence in reliability of each or combined tests. Functional examination of the     shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It     includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.      As far as the investigators know, correlation of Cyriax functional examination with the     ultrasonographic findings has never been reported before. Therefore, the aim of this study is     to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings     in patients with shoulder pain.   "
45643|NCT02688192|"     This clinical trial studies a mobile health fitness program for adolescent and young adult     childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk     to have negative late effects from treatment and to develop chronic health conditions. A     sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early     mortality. Physical activity reduces the risk for cardiovascular disease and early mortality,     improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and     it is also positively associated with quality of life. Programs and technologies that promote     physical activity are important because health behaviors adopted by adolescent and young     adult childhood cancer survivors are likely to continue into adulthood. A mobile health     fitness application may motivate adolescent and young adult childhood cancer survivors to     engage and maintain physical activity.   "
45644|NCT02688179|"     Up to 50% of patients over 60 years old develop postoperative delirium following cardiac     surgery. Delirium increases morbidity and mortality, and may lead to long-term cognitive     impairment similar to patients with a diagnosis of Alzheimer's disease. The underlying     mechanisms behind delirium are not understood, and therefore the current prevention and     treatment strategies are inadequate. Several hypotheses exist for the pathophysiology of     delirium, one of which is the role of neuroinflammation. The stress associated with high-risk     procedures such as cardiac surgery may lead to systemic inflammation causing endothelial     dysfunction and disruption of the blood brain barrier (BBB). When this occurs, the brain is     susceptible to neuronal injury via neuroinflammation after which a state of delirium may     ensue. To characterize the mechanisms of neuroinflammation in delirium, the investigators     will explore the biomarkers most closely linked to each step of the proposed pathway.   "
45645|NCT02688166|"     This research study can help understand how cardiac changes may occur with radiation therapy     to the heart based off measurements obtained through biomarkers and cardiac imaging.      Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Cardiac     magnetic resonance imaging (CMR) provides the ability to quantitatively measure cardiac     function and injury. The cardiac biomarkers that will be tested are effective in the     diagnosis, risk-stratification, and monitoring of heart failure.   "
45647|NCT02688140|"     Acute promyelocytic leukemia (APL) is a rare subtype of acute myeloid leukemia (AML)     characterized by consistent clinical, morphologic, and genetic features. According to the FAB     classification APL is designated asM3 leukemia and assigned to the WHO defined type of AML     with recurrent cytogenetic abnormalities, acute promyelocytic leukemia with     t(15;17)(q22;q12), (PML/RARα) and variants.      Despite the dramatic progress achieved in frontline therapy of APL with ATRA plus     anthracycline-based regimens, relapses still occur in approximately 20% of patients.     Moreover, these regimens are associated with significant toxicities due to severe     myelosuppression frequently associated with life-threatening infections and potentially     serious late effects including development of secondary MDS/AML. In a recent randomized     clinical trial in low/intermediate-risk APL (WBC ≤ 10 GPt/l APL0406 trial) a combination of     arsenic trioxide (ATO) and ATRA has been shown to result into better survival with     significantly lower toxicity rates compared to the standard ATRA + idarubicin (AIDA) therapy.     Inspired by the results of this trial the investigators intend to perform a randomized study     in high-risk APL (WBC at diagnosis > 10 GPt/l) comparing standard AIDA-based treatment with     ATO/ATRA combination including low-doses idarubicin during induction. The investigators     propose a modified ATO/ATRA protocol with the addition of two doses of IDA (50% compared to     standard AIDA induction) for induction because of the anticipated need of adding     anthracyclines to control hyperleukocytosis and to achieve long-term disease control in this     high-risk APL population. This is followed by 4 cycles of ATO/ATRA consolidation therapy. As     in the APL0406 study for low/intermediate-risk patients the investigators expect less severe     hematologic toxicity and treatment-related mortality resulting in an improved outcome for     patients in the experimental arm. Furthermore, from the start of consolidation, these     patients (in contrast to the standard arm) can be treated on an outpatient basis, which is     also considered to be associated with an improved quality of life. The study will be     conducted as a European intergroup study.   "
45648|NCT02688127|"     This study evaluate role of tranexamic acid in reducing blood loss among pregnant women     undergoing cesarean section because of placenta previa .Half of participants will receive     tranexamia acid drug While the other half will receive placebo.   "
45649|NCT02688114|"     Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's     esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after     successful RFA treatment in approximately 1/3 of patients. The aim of this study is to     characterize the healing process of the esophageal mucosa, histologically and at the     molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.   "
45650|NCT02688101|"     Multicenter, open-label, dose-escalation and pharmacokinetic study.   "
45652|NCT02688075|"     The purpose of this study is to evaluate canagliflozin use in the treatment of type 2     diabetes mellitus (T2DM) and generate evidence of its effectiveness, safety and     patient-reported outcome (PRO) in a usual clinical practice in Canada.   "
45653|NCT02688062|"     The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold     with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and     complete spinal cord injury, compared to the treatment of surgical intradural decompression     and adhesiolysis only.   "
45654|NCT02688049|"     The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or     neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal     cord injury.   "
45655|NCT02688036|"     The purpose of this study is to determine whether hypofractionated concurrent     chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent     chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.   "
45656|NCT02688023|"     Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of     this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin,     irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with     resectable colorectal cancer.   "
45657|NCT02688010|"     Noise is a hazard for newborn. In 1997, the American Academy of Pediatrics determined that     safe sound levels in the neonatal intensive care unit (NICU) should not exceed 45 dB which     has been rarely achieved. High intensities of noise have several negative effects on preterm     newborns. Also, they are exposed to either continuous bright light continuous near darkness     or unstructured combination of the two during their hospitalizations. The investigators     primary objective is to determine the impact of reduced noise levels and cycled light on     growth parameters and visual development in preterm infants.   "
45658|NCT02687997|"     Prospective study of sleep disordered breathing in a lung cancer screening cohort.   "
45659|NCT02687984|"     Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2     different molecular weights (MW) (low and high MW as test treatments) of poly     (DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to     intermediate MW PLGH polymer following single subcutaneous (SC) injection of RBP-7000 in     subjects with stable schizophrenia.      Secondary Objective:      To evaluate the safety and tolerability of single SC injections of RBP-7000 using a PLGH     polymer of 2 different MW (low and high MW as test treatments) compared to intermediate MW     polymer in subjects with stable schizophrenia.   "
45660|NCT02687971|"     The purpose of this trial is to determine the efficacy and safety of a combined therapy using     thermotherapy (TT) (one session, 50 degrees Celsius for 30) + miltefosine at a standard dose     of 2.5 mg/kg/day for 21 days for the treatment of uncomplicated CL in Peru and Colombia   "
45661|NCT02687958|"     Cisplatin and Etoposide is the standard of care in NEC originating from the gastro-intestinal     tract and lung, based on retrospective studies.      Nevertheless the prognosis of this group of patients is still poor with median survival of     less than 20 months.      Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated to     be active in patients with well and moderately differentiated primitive neuroectodermal tumor     (pNET).      Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR)     pathway is overexpressed in NEC.      Based on the activity of Everolimus in the treatment of patients with well and moderately     differentiated p-NET and on the evidence that even poorly differentiated forms express the     pathway of m-TOR is conceivable that Everolimus could be active even in NEC.   "
45662|NCT02687945|"     The purpose of this study is to determine if outpatient physiotherapy results in improved     and/or more rapid achievement of functional outcomes and quality of life in comparison to     those patients who do not undergo outpatient physiotherapy after total hip arthroplasty   "
45754|NCT02686749|"     This study is a multi-center, randomized, unblinded, clinical trial. The objective is to     determine if catheter-based atrial fibrillation (AF) ablation is superior to medical     treatment in patients with impaired left ventricular (LV) function who have been diagnosed     with symptomatic AF within the past 6 months.   "
46728|NCT02673996|"     Objective: In this pilot study, we will test the hypothesis that patients with POTS (age     18-60 years) will have a higher percentage of functional antibodies to adrenergic receptors     compared with control subjects without POTS.   "
45663|NCT02687932|"     Functional MR is caused by adverse left ventricular remodeling after myocardial injury and     associated with an increased incidence of heart failure and death. Because secondary     functional MR usually develops as a result of LV dysfunction, diuretics, beta blockers,     angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), and     aldosterone antagonists are given to patients with functional MR in line with the guidelines     in the management of heart failure. However, functional MR appears to remain common despite     use of these drugs and current medical treatment is usually insufficient for reducing MR or     reversing the adverse LV remodeling. As LCZ696 is a dual-acting inhibitor of the     renin-angiotensin-aldosterone system (RAAS) and neutral endopeptidase (NEP), LCZ696 has     greater hemodynamic and neurohormonal effects than ARB alone. Investigators try to examine     the hypothesis that LCZ696 is superior to ARB alone in improving functional MR in patients     with LV dysfunction and functional MR.   "
45664|NCT02687919|"     This is a research study. The investigators are inviting participants to participate in this     research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple     Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of     the following: liver disease, kidney disease, diabetes, active heart disease, heart block or     arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet     use, psychosis or other psychiatric disorder likely to impact ability to comply with study     procedures, any change in prescription medication for a mental health problem such as     depression or anxiety in the last three months.      The purpose of this research study is to determine whether or not a modified Paleolithic diet     results in any change in health in persons with RRMS compared to usual care. The     investigators define usual care as the typical or usual physician recommendations for the     treatment of RRMS.      The Paleolithic diet (or Paleo diet), also referred to as the caveman diet, Stone Age diet,     and hunter-gatherer diet, is a modern nutritional plan based on the presumed ancient diet of     wild plants and animals of ancestral humans during the Paleolithic era (a period of about 2.5     million years duration that ended around 10,000 years ago with the development of     agriculture). The diet consists mainly of fish, grass-fed pasture raised meats, vegetables,     fruit, fungi, roots, and nuts, and excludes grains, legumes, dairy products, salt, refined     sugar, and processed oils.      To the investigators' knowledge, most neurologists prescribe medications that may reduce or     prevent future disability, but few prescribe dietary modifications unless needed for other     concomitant disease.   "
45665|NCT02687906|"     A single dose infusion of Carbavance (meropenem-vaborbactam) is being tested for     dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to     less than 18 years of age with serious bacterial infections   "
45666|NCT02687893|"     Growing evidence provided by many observational studies has established a strong link between     decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality     induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the     influence of poor sleep quality on glycemic control of patients with Type 1 diabetes mellitus     (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM has been reported,     and this sleep loss can be attributed in part to nocturnal hypoglycemia. Nocturnal iatrogenic     hypoglycemia is a limitation of current intensive insulin therapies. Although severe     hypoglycemia is associated with adverse events such as seizures and death, less severe     nocturnal hypoglycemia has been linked to broad range of adverse consequences, both acutely     and long term. Hypoglycemia stimulates the sympathetic nervous system as a stress response,     leading to the stimulation of the hypothalamic-pituitary-adrenal axis (HPA). This results in     a counter regulatory hormone cascade, which elicits an excessive cortisol secretion, which is     known to cause sleep disturbance and could impair glucose homeostasis after the hypoglycemic     event. The hyperinsulinemia in T1DM patients promotes HPA hyperactivity as well, which is     also associated with impaired sleep quality by leading to sleep fragmentation, decreased slow     wave sleep and shortened sleep duration. Sleep disturbances due to nocturnal hypoglycemia can     exacerbate HPA axis dysfunction, adversely affecting the sleep-wake cycle.      The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.   "
45667|NCT02687880|"     Many chemotherapy and radiation-containing regimens for cancer or prior to bone marrow     transplantation can cause sterility in children and young adults. In addition, some human     disease conditions (e.g., Klinefelter's) are associated with infertility. Semen     cryopreservation is available as a fertility-preserving option for post pubertal boys and     adult men, but many do not take advantage of this option due in part to lack of information,     illness, and/or time constraints relative to their treatment plan. Currently, no     fertility-preserving options are available for prepubescent boys who are not yet producing     sperm. The primary objective of the proposed study is to 1) Optimize techniques for     cryopreserving testicular tissue, 2) Assess malignant contamination in testicular tissues and     3) develop methods to enrich spermatogonial stem cells and remove malignant contamination     from testicular tissue. In addition, this study will process and cryopreserve tissue and/or     cells for participating patients as a resource for future elective procedures to attempt     fertility restoration.   "
45668|NCT02687867|"     To obtain a better understanding on the comparative effectiveness of dabigatran versus     Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial     fibrillation (NVAF) in a real-life setting.   "
45669|NCT02687854|"     To obtain a better understanding on the comparative effectiveness of apixaban versus VKA     (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial     fibrillation) in a real-life setting.   "
45670|NCT02687841|"     Hospital acquired acute kidney injury is an important negative outcome predictor for     hospitalized patients. Uremic toxins accumulated after a given renal insult. Some of these     uremic toxins are protein bound and may accumulated after renal impairment, owing to both     impaired filtration, and inflammation. Recent animal studies have reported that accumulation     of uremic toxins, namely indoxyl sulfate and p-cresol, would down regulate endothelial     progenitor cells and in turn affect renal recovery. Elimination of these protein bound uremic     toxins with an activated charcoal would help restore endothelial function. We will conduct a     double blinded randomized placebo controlled trial, which aims to determine that if oral     activated charcoal will retard progression of AKI. Also, a panel of markers for endothelial     function will also be determined.   "
45673|NCT02687802|"     The objective of the study is to estimate the incidence of asynchrony and to assess its     relationship with respiratory mechanics. This will be a prospective cohort study, including     patients under invasive mechanical ventilation. Within 48h post intubation, the investigators     will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance     and resistance. Participants will be followed up from intubation to mechanical ventilation     liberation. The investigators will register clinical signs of asynchrony and record     ventilator waveforms continuously and quantify patient-ventilator asynchrony. The     investigators will calculate the total asynchrony index (AI) and of each asynchrony type     (ineffective triggering, double triggering, auto triggering, short cycling and prolonged     cycling). Participants will be followed up until hospital discharge.   "
45674|NCT02687789|"     Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a     disturbance in the vaginal microbiological milieu. Anaerobic bacteria, such as Gardnerella     vaginalis and Atopobium vaginae overgrow the physiologic vaginal flora which is dominated by     Lactobacilli. BV can arise and remit spontaneously but often presents as a recurrent disease.      New findings indicate that the presence of an adherent bacterial biofilm on the vaginal     mucosa seems to be the reason for the recurrence of BV as well as the overgrowth condition by     anaerobic bacteria. Biofilms are defined as a structured consortium of bacteria embedded in a     matrix of extracellular polymeric substances (EPS).      The purpose of this study is to achieve substantial results with respect to tolerability and     safety, and to gain further knowledge on the clinical efficacy of Vaginal suppository WO3191,     the investigation will be performed in a parallel-design, double-blind, randomised,     controlled manner.   "
45675|NCT02687776|"     Observational cohort study examining the perioperative course of copeptin in patients     undergoing elevated-risk surgery.   "
45676|NCT02687763|"     A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and     Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being     considered and/or evaluated for any solid organ transplant (heart, liver or kidney)   "
45677|NCT02687750|"     Testing of a dual tuned proton/fluorine MRI radio frequency coil      Images were collected from plastic fluorine phantoms taped to the upper thigh of health     volunteers.      This trial was performed as part of an application for a Health Canada Investigational Device     Exemption (Protocol # 226949)   "
45678|NCT02687737|"     The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There     are few therapeutic options offered to these individuals. One more recent therapeutic option     is Expiratory Muscle Strength Training (EMST), which has been used successfully to maintain     or increase expiratory force generating pressures, cough function, and swallowing in a number     of disease populations. Recently, the investigators have noted improvements in oral transit     time during swallowing in individuals with Amyotrophic Lateral Sclerosis (ALS) that could     potentially be attributed to improved base of tongue functioning and muscle activation.      There has been one study that demonstrated that breathing training resulted in increased and     prolonged submental (under the chin) muscle activation as evidenced by surface     electromyography. However, no studies have investigated the activation of the tongue muscles     during various swallowing and breathing exercises. A small needle electrode (fine wire EMG)     is standard of care in diagnosing muscular diseases because it can determine amount of muscle     recruitment for muscles throughout the body. This aim of this research study is to examine     the effects of breathing exercises and swallowing exercises on tongue muscle activity in     healthy adults.   "
45679|NCT02687724|"     GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A     nationwide multi-centred randomised controlled trial (RCT) investigating the use of GLM dose     adjustment in ulcerative colitis (UC). The primary objective is to ascertain if dose     adjustment of GLM based on GLM drug levels and FCP levels results in higher response and     remission rates than standard SmPC dosing.   "
45680|NCT02687711|"     Study is the first study after commercialization of brivaracetam. It is designed to collect     real world information on the effectiveness of brivaracetam in patients with Partial Onset     Seizure epislepsy who are treated in standard clinical practice.   "
45681|NCT02687698|"     Parkinson's disease concerns some defects in carbohydrates metabolism involved in the     progress of the pathology. Ketogenic diet has been largely studied as treatment on     drug-resistant epilepsy and other neurologic diseases, but there is little information on the     impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study     is thus to evaluate the effect of a lipid and protein controlled diet on resting energy     expenditure, body composition and symptoms in patients with Parkinson's disease.   "
45682|NCT02687685|"     SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and     maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period     strategy that has proven to benefit the initiation and continuation of human lactation and     decreased hospitalization during the first week of life. This study aims to determine the     effect of the initiation of SSC at birth (immediate vs. early) in healthy, full term newborns     treated at Universidad de La Sabana Clinic, on the duration of exclusive human lactation.      Research question: What is the effect of immediate SSC at birth (immediate vs. early) on the     duration of exclusive human lactation in full-term newborns treated at the Universidad de La     Sabana Clinic?      Methodology: A random blind clinical trial was performed in which full-term healthy newborns     that are attended at the Universidad de La Sabana Clinic are included. The blind participants     will be those persons measuring the results and analysing the data. The sample size is     calculated for a type I error of 5%, a two tailed type II error of 20%, therefore estimating     percentage losses of 30%; 150 infants were included per group. Randomization will be     performed using permuted, size 6 blocks. Descriptive analysis will be conducted using central     tendency and dispersion measurements. A bivariate analysis will be performed to determine     which variables are associated with exclusive human lactation at 6 months. For continuous     variables, the Student t- test will be used for independent samples or the Wilcoxon rank sum     test, in case the assumptions of normality for the t-tests are not fulfilled. The assumption     of normality will be evaluated with the Shapiro Wilk and Kolmogorov-Smirnov test. Categorical     variables in contingency tables will be constructed, assessing independence between variables     with the Chi-square test or Fisher's exact test when the assumption of the number of cases is     not met by the cells in the contingency tables, times two. It will be calculated as a     measurement of the effect of relative risk (RR) with confidence intervals; the adjusted     measurements will be calculated using a multivaried regression Poisson model, variables with     significant results will be used in the bivariate analysis and those with biological     plausibility used for the adjustment. The analysis will be carried out for a two-tailed type     I error level of 5%. The Stata 11 program will be used for the data analysis. An interim     analysis will be performed upon submission of half of the expected events (106), setting     limits for early termination of the trial according to the method proposed by Pampallona and     Tsiatis (1994).      Intervention: There will be 2 SSC randomization groups, early vs. immediate. After completing     the neonatal adaptation process and according to the group assignment, it will proceed to     leave the newborn with the mother in accommodation. Prior to discharge, the IBFAT scale will     be applied. Monitoring will initially be performed with a face valuation between 3 and 10     days of life, then monthly telephone calls for 6 months to verify the status of human     lactation.      Results: To determine whether early versus immediate SSC has an impact on the duration of     exclusive human lactation.   "
45683|NCT02687672|"     This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as     sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in     treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on     the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into     the injured spinal cords of patients.   "
45684|NCT02687659|"     Physical inactivity is a major public health issue. Prescription of physical activity appears     necessary in some situation with cardiovascular risk. It is important to both qualify and     quantify daily physical activity.      The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt)     performance in 12 healthy subjects, wearing this system over the daytime during one week.   "
45685|NCT02687646|"     Sequential administration of MSCs obtained from adipose tissue is an effective and safe     treatment for acute graft versus host disease refractory to first-line treatment. Furthermore     the infusion of these cells produces a biological pattern in patients that relates to the     clinical response.   "
45734|NCT02687009|"     This study evaluates the safety of Niclosamide in patients with colon cancer that are     undergoing primary resection of their tumor. This is a phase I study with three dosage levels     to determine the maximum tolerated dose (MTD).   "
45833|NCT02685709|"     Octreotide capsule is a novel, orally-administered formulation of the commercially-available     injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated     sustained biochemical response up to 13 months in patients with acromegaly previously managed     with somatostatin analog injections (ref).      The purpose of this study is to compare the efficacy safety and patient reported outcomes     between oral octreotide capsules and injectable somatostatin analogs.   "
45686|NCT02687633|"     The investigators are running an intervention study for young children with Tuberous     Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that     may improve social and communication skills in children with TSC. Eligible families will have     a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also be     available to attend the weekly intervention sessions at UCLA.      The intervention will focus on teaching caregivers skills to improve the social and     communication outcomes of their children. The content of the intervention will be     individually tailored to the child's developmental level. The intervention involves     pre-assessments, an intervention period of daily 60 minute sessions for 10 days, followed by     weekly 60 minute sessions for 10 weeks, and post-assessments. The classroom can have up to 3     parent-child dyad and the curriculum focuses on improving social-communication and play     skills.   "
45687|NCT02687620|"     The purpose of this prospective cohort study is to evaluate the influence of serum drug     levels and development of anti-drug antibodies on clinical response to anti-TNF agents in     ankylosing spondylitis(AS) treatment. Secondary aims are to assess the demographic, clinical     and laboratory variables associated with the development of anti-TNF drug antibodies at     baseline or disease course and to reveal the impact of anti-drug antibodies on long-term     efficacy or safety in particular drug survival in AS patients treated in daily clinical     practice.   "
45689|NCT02687594|"     An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide,     sucrose, and starches. It was well tolerated in the clinical development program. The     approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in     adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal     dialysis).      It is of major interest to observe the drug in daily use outside of controlled trial     settings. The Marketing Authorisation Holder wishes to obtain further systematic data within     a non-interventional study to investigate short and long-term safety.      Effectiveness and Treatment adherence during real-life use will be evaluated.   "
45690|NCT02687581|"     This study is designed to evaluate the effectiveness of a novel amblyopia treatment -     Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia.      Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the     amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching     group or 2) 12-hour IO-therapy glasses group.   "
45691|NCT02687568|"     Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for     patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally     recommended under sedation and also carried out in practice here.      The vital signs monitoring to avoid complications is dictated by current national guidelines.     Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In     patients with severe heart disease an ECG recording should be used additionally. Moreover,     the guidelines require that the sedation is clinically monitored continuously to avoid an     unwanted anesthetic stage. Such evaluation, however, is often difficult under clinical     conditions and even counterproductive, since a constant response and tactile stimulation of     the patient (to check clinically the depth level of sedation ), interrupts endoscopic complex     intervention. However, clinical most relevant aspect is the avoidance of unrecognized     transition of patients from the stage of deep sedation in an anesthetic stage.      Current recommendations do not take into account new study results from a gender perspective,     which showed that women and men need a different wake-up time using the EEG derivation means     by using the Narcotrend after total intravenous anesthesia, which may be due to different     total doses of sedatives needed. However, the research group has been demonstrated in a     previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective     adaptation of sedation, in particular a more rapid recovery time by a lower dose of the     administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde     cholangiopancreatography-(ERCP).      In the presented study the investigators evaluate the extent of gender differences in the     wake-up time after sedation with propofol during colonoscopy when using EEG monitoring.   "
45692|NCT02687555|"     The purpose of this study is to determine whether a computerized training, Cognitive Bias     Modification targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma     in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition.     Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional     cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for     Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.   "
45694|NCT02687529|"     To compare the positivity rate of the investigational assay to the currently approved     QuantiFERON-TB Gold In-Tube assay.   "
45695|NCT02687516|"     This study aims to evaluate the effectiveness of Family-based behavioral social facilitation     therapy (FBSFT) in the treatment of severe obesity in children and adolescents compared to     treatment as usual (TAU). The FBSFT condition includes 17 weekly family-based treatment     sessions at the hospital obesity clinic followed by monthly follow-up sessions with their     local nurse and follow-up sessions at the hospital every third month for 2 years. The     treatment targets both child and parent life-style; eating habits, physical activity,     sedentary activity and sleep habits. Behavior modification techniques are employed; such as     self-monitoring, goal setting, reward systems, problem solving and stimulus control. In     addition, FBSFT focuses on facilitating lifestyle change across different settings (family,     friends, school and community) and harnessing social support for healthy habits, which is     considered important for long-term weight control. The TAU condition involves an assessment     day with the multidisciplinary team (pediatrician, dietician, physical therapist and     psychologist) at the hospital obesity clinic. Further a session with the nurse at the     hospital clinic making a plan for behavioral lifestyle changes followed by monthly follow-up     sessions with their local nurse and follow-up sessions at the hospital clinic every third     month for one year.      SAMPLE AND STUDY DESIGN. The sample will consist of children and adolescents (aged 8-16)     referred to the Obesity Outpatient Clinic at Haukeland University Hospital. Criteria for     admission to the clinic is an (IOTF) isoBMI of > 35, or a isoBMI > 30 with obesity related     co-morbidity. Based on current clinic data, estimations suggest that about 60 families of     children with severe obesity will be referred to the Obesity Outpatient Clinic every year and     be offered treatment. Recruitment will start in February 2014 and will continue in 2015 and     2016. After consenting to participation and completion of the initial assessments the     families will be randomized to either FBSFT or treatment as usual (TAU). After one year the     families randomized to TAU will be offered the FBSFT treatment. Measurement points for the     most important outcome measures will be pre-treatment, post-treatment (at approximately 6     months), at 12 months, 18 months and 24 months.      OUTCOME VARIABLES. Anthropometrical measures: Height, weight and waist-circumference,     DXA-scans and bio-impedance measurements for determining the distribution of fat and muscle     tissue. Physiological measures: Blood samples will be drawn in the morning after an overnight     fast. Including measurements of total-cholesterol, HDL, LDL, TG, ASAT, ALAT, gamma-GT,     bilirubin, creatinin, HbA1c and fasting insulin, c-peptide and glucose, TSH, fT4, CRP.     Cortisol measurements from saliva and urine. Measurement of bloodpressure. Food records: The     parents will be instructed to help their children to keep a diary of food and beverage intake     for five days. They will use an electronic kitchen scale to weigh the food. Physical     activity: Physical activity and sleep will be measured by using accelerometers. Psychological     measures: The Child Behavior Checklist (CBCL) is a 138-item rating scale assessing behavioral     and emotional symptoms in children/youth. Children's Depression Inventory (CDI). CDI is a     27-item self-report test assessing symptoms of depression in children (7-17 years).     Self-Perception Profile for Children (SPPC). SPPC is a self-report measure of self-perception     in children aged 8 to 14 years. The Dutch Eating Behavior Questionnaire Child version (DEBQ)     is a measure of disturbed eating patterns in children and youth. The Youth Eating Disorder     Examination-Questionnaire (YEDE-Q) is a self-reported measure of eating patterns and eating     disorder psychopathology. OTHER MEASUREMENTS INCLUDED. The Parenting Scale (PS) is a 30-item     questionnaire designed to measure different parental disciplines with children/youth. The     scores on three sub-scales are calculated - Laxness, Overreactivity and Verbosity. The     Barriers to Treatment Participation Scale (BTPS). The 44-item scale is developed and     validated to address drop-out from treatment with out-patient psychological treatment of     children and adolescents. Child and parent acceptability of the treatment will be measured by     the FBSFT Acceptability Questionnaire.      STUDY AIMS:        1. To evaluate the effect of FBSFT compared to TAU for treatment of severe childhood and          adolescent obesity in an ordinary health care setting on BMI, BMI SDS, body composition,          cardio-metabolic health, eating habits, physical activity as well as psychological          well-being.        2. To identify predictors of treatment success and treatment drop-out with a focus on          family variables and mental health.        3. To evaluate treatment (FBSFT) implementation and treatment acceptability for children,          parents and health care workers and experienced barriers to treatment, and how these          factors influence children's and parents' treatment response.   "
45696|NCT02687503|"     Probiotics are microorganisms that are believed to provide health benefits when consumed. The     term probiotic is currently used to name ingested microorganisms associated with beneficial     effects to humans and animals. Probiotics are popularized in the lay literature for many     different clinical problems. They have been studied in infants and children as a preventive     or treatment for a variety of infections. Studies on the medical benefits of probiotics have     yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be     conclusively proven for most of the studies conducted thus far. The putative benefit of     probiotics in the prevention of infection relates to potential benefits to the innate and     adaptive immune systems of infants.      The goals of this investigation are to study immune system cell function in children who are     taking probiotics.      To accomplish this goal, the investigators propose a pilot study for which blood samples will     be obtained prior to and post probiotic use in children greater than or equal to 12 months-36     months at the end of 3 months.   "
45697|NCT02687490|"     Abraxane in patients with visceral metastases dominant metastatic breast cancer   "
45747|NCT02686840|"     The aim of this work is to compare the effectiveness of vaginal versus sub-lingual     misoprostol for medical treatment of first trimester missed miscarriage.   "
45859|NCT02685371|"     This study will evaluate the effect of deep breathing manoeuvres on inter ventricular     interdependency physiology. By providing further insight in this basic physiology we want to     add more comprehensive data in favor or not of constrictive pericarditis diagnostic criteria     currently used in cardiovascular magnetic resonance.   "
45751|NCT02686788|"     The purpose of this study is to assess the impact of TMP001 in the treatment of patients with     relapsing-remitting multiple sclerosis (RRMS). Therefore the average total number of contrast     enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 during treatment with     TMP001 is compared to the average total number of CELs on brain MRI scans at week -4 and     baseline in these patients .      Based on promising preclinical results, the investigators assume a comparable effect of     TMP001 on reduction of contrast-enhancing lesions as shown for other immunomodulatory     substances in recent clinical studies.   "
45698|NCT02687477|"     This project is focused on the treatment of severe obstructive sleep apnea with pulmonary     artery denervation (PADN). Although it has now been proved that continuous positive airway     pressure (CPAP) is the primary treatment for obstructive sleep apnea, on the other hand,     there is evidence that 25 to 50% of patients can not tolerate CPAP.      The investigators previously reported the safety and efficacy of pulmonary artery denervation     (PADN) for treatment of pulmonary hypertension. Excessive sympathetic activation play an     important role in the occurrence and development of OSA and cause cardiovascular events. It     is worth evaluating the feasibility and tolerance of introducing PADN at the severe stage of     obstructive sleep apnea. Therefore, the purpose of our study is to evaluate the safety and     feasibility of PADN in the treatment of severe OSA.   "
45699|NCT02687464|"     Rationale and Aim: The standard treatment for acute appendicitis in children is appendectomy.     An increasing body of evidence from the adult literature suggests that acute appendicitis may     be treated effectively with antibiotics alone, avoiding the need for surgery. The aim of this     study is to investigate the effectiveness of non-operative treatment of acute appendicitis in     children.      Study design: Pragmatic, parallel-group, unmasked, non-inferiority multicentre randomized     controlled trial (RCT).      Patient allocation: Children will be randomly allocated (age 5-16 years) with a diagnosis of     acute appendicitis to either laparoscopic appendectomy or treatment with antibiotics.     Randomization will be performed using stratification to ensure equal distribution between     groups of presenting clinical and demographic features that may influence outcome including     gender, duration of symptoms and center.      Interventions: One group of children will undergo laparoscopic appendectomy that is the     current standard treatment for children with acute appendicitis. The other group will be     treated with intravenous antibiotics. A treatment pathway specifically designed for this     study will be used.      Primary Outcome: To be meaningful to parents of, and clinicians treating, children with acute     appendicitis, the primary outcome is treatment failure defined as: (i) any additional     intervention related to appendicitis requiring general anesthesia within 1 year of     randomization (including recurrence of appendicitis after non-operative treatment, which we     will treat with appendectomy) or (ii) negative appendectomy. Secondary outcomes are: (i)     complications; (ii) time to discharge following randomization; (iii) number and duration of     hospital admissions.      Sample size and data analysis: The proposed RCT has a 20% non-inferiority margin to test the     null hypothesis that treatment with antibiotics is inferior to appendectomy. Based on data     from collaborating centers and a pilot study that we have performed, we expect recruitment of     978 children in total (90% power) over 19 months allowing for drop out. Follow-up will be for     12 months.   "
45700|NCT02687451|"     The purpose of the study is to evaluate the efficacy, tolerability, safety and     pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe     post-operative pain in pediatric subjects.   "
45701|NCT02687438|"     Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL     mini implants immediately following ethmoid sinus surgery   "
45702|NCT02687425|"     The purpose of this study is to assess the safety and efficiency of adding pioglitazone to     chronic phase chronic myelogenous leukemia patients having received imatinib mesylate who     have acquired a stable molecular response but not complete molecular response.   "
45703|NCT02687412|"     Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS     is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize     hospital stay without an increased readmission rate and reduce healthcare costs, all without     compromising patient safety. It has been used successfully in non-malignant gynecological     surgery, but it has been proven to be especially effective in elective colorectal surgery.     However, no consensus guideline has been developed for gynecological oncology surgery     although surgeons have attempted to introduce slightly modified FTS programmes for patients     undergoing such surgery. NO randomised controlled trials for now.      The advantages of fast-track most likely extend to gynecology, although so far have scarcely     been reported. There is a existing research showed FTS in gynecological oncology provide     early hospital discharge after gynaecological surgery meanwhile with high levels of patient     satisfaction.      The aim of this study is to identify patients following a FTS program who have been     discharged earlier than anticipated after major gynaecological/gynaecological oncologic     surgery and analyze the complication after surgery.   "
45704|NCT02687399|"     The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the     total blood loss associated with the total knee arthroplasty.   "
45705|NCT02687386|"     This is an open-label, sequential dose exploration study of single agent EEDVSMit     administered by intravenous (IV) infusion twice weekly, followed by weekly maintenance     dosing, in children with recurrent/refractory solid or CNS tumours.   "
45706|NCT02687373|"     This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy     children aged 5 months through 9 years of age living within approximately 10 km of the study     clinic(s) (Siaya County Referral Hospital, or Wagai dispensary, a government health facility     in Wagai division) will be eligible for participation in Part 1; healthy infants aged 5     months - 12 months inclusive will be eligible for Part 2.   "
45707|NCT02687360|"     Neuropathic pain is difficult to treat and is associated with the development of mood and     substance use disorders. Most medications are only moderately effective, and deep brain     stimulation is being used to treat sever chronic neuropathic pain. However, this requires     brain surgery. The goal is to investigate the use of transcranial magnetic stimulation (TMS)     directed at the medial prefrontal cortex and anterior cingulate for this disorder. These     brain regions are in the prefrontal cortex, and research from deep brain stimulation studies     indicated that stimulating this region may help treat pain. This is a pilot study to     investigate the use of transcranial magnetic stimulation (TMS) directed at the regions in the     prefrontal cortex using the H7 coil, which was developed to reach these deeper brain     structures. While previous studies have investigated rTMS for pain, none, have used this coil     to target these brain regions. This study will investigate active vs sham treatment in     chronic pain participants.   "
45708|NCT02687347|"     The research hypothesis of this study is: In patients with moderate to severe cancer related     pain, the addition of low dose methadone to an existing opioid significantly reduces pain     severity compared to low doses morphine.   "
45709|NCT02687334|"     The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2)     during anesthesia induction.   "
45710|NCT02687321|"     To evaluate and to compare the effectiveness of CA-125 and HE4 serum levels in epithelial     ovarian cancer (OC) in follow-up in terms of time to detection of elevation after the end of     the first line treatment. To evaluate the lead-time of the rise of marker levels before     epithelial OC recurrence diagnosis by Computed tomography (CT) imaging method. To evaluate     the appropriate HE4 cut-off value for follow-up of patients after the treatment of ovarian,     Fallopian tube and primary peritoneal cancer.   "
45711|NCT02687308|"     Prospective randomized study performing open anterograde anatomical radical retropubic     prostatectomy (RRP2A) using the same technique of minimally invasive surgery described by the     Pasadena consensus for the procedure assisted by robot, compared with the anatomical radical     prostatectomy technique described by Patrick Walsh (RRP). Recent studies have shown benefits     in the minimally invasive surgical techniques approaches, laparoscopic radical prostatectomy     (LRP) and, more recently, robot-assisted radical prostatectomy (RARP). These minimally     invasive techniques were associated with advantages in complications, like intraoperative     bleeding, transfusion rates and in earlier recovery of important genitourinary functions such     as urinary continence and penile erection. But still has not been demonstrated conclusively     advantages as oncological control and it is believed that there are about 200 to 250 cases of     learning curve so that the rates of complications and positive surgical margins become stable     and similar to the open radical prostatectomy. These facts associated with the high cost of     robotic technology still have limited the generalization of this approach in many developing     countries such as Brazil. While the majority of studies made by comparing the radical     prostatectomy (RP), robot X laparoscopic X open, show a slight advantage in the first two,     there is a significant bias in these studies, which is that the surgical technique used in     each procedure differs significantly from minimally invasive and open surgical techniques.     The evolution of minimally invasive radical prostatectomy was based on an entirely different     anatomical benchmark of that described by Patrick Walsh. While robotics and laparoscopic     techniques dissect the prostate, bladder neck and the neurovascular bundle in an antegrade     way, from bladder neck to the apex, the Walsh RRP technique is completely different in     several ways, the dissection is made from prostatic apex to the bladder neck, so the     retrograde direction, the posterior layer of Denonvilliers' fascia, is always included with     the specimen, and urethrovesical anastomosis, usually performed with multifilament     interrupted suture, only for indicating the major differences. The RRP2A will be performed by     incision (open surgery) and will be compared with the anatomical radical prostatectomy     technique described by Patrick Walsh RRP, and performed by the same surgeons.   "
45712|NCT02687295|"     Objective:      The purpose of this study was to investigate the possible effects of green-plant thylakoid     supplementation to a restricted diet intervention study in overweight to obese men.      Methods:      Overweight-obese men (BMI 25 - 35) were treated to a 30 E% restricted diet for one month,     followed by one month of stabilization. Then they were divided in two treatment arms of one     month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). Body measurements     and blood samples were taken throughout the study.   "
45713|NCT02687282|"     Mallampati class change has not been well evaluated during the cesarean delivery. Various     factors regarding to cesarean delivery might influence this changes. The aim of this study     was to evaluate the Mallampati class before and after cesarean delivery and to identify     predictive factors of the changes..      Study Type: Observational Cross-sectional study   "
45714|NCT02687269|"     Despite surgical and medical innovation have reduced mortality rates in cardiac surgery, the     disease severity and operative procedural complexity have increased and morbidity rate is     still high. Ischemia-reperfusion (I/R) injury, redefined in cardiac surgery     post-cardioplegic injury (2) as a whole of ischemia-reperfusion, cardiopulmonary bypass and     surgical trauma, has been recognized as a significant contributor to mortality and morbidity.     I/R injury is classified as reversible or irreversible. Reversible injury includes     arrhythmias, edema, vascular dysfunction and contractile stunning expressed as low output     syndrome without cell death and without apparent signs of infarction or other serum injury     markers. Irreversible reperfusion injury includes apoptosis and necrosis. I/R injury is a     complex process associated with increase of radical, oxidant and cytokines production,     complement and neutrophil activation and endothelial activation leading to microvascular     dysfunction and deterioration of coronary flow reserve. In the hypoxic heart increase     anaerobic lactate production, K+ efflux and membrane depolarization. The intracellular Na+     concentration rises as a consequence of slow Na+ channels inactivation and the induction of     voltage-gated Na+ channel late current component (late INA). Intracellular Na++ accumulation     enhanced activity of reversed-mode Na+-Ca++ exchanger causing intracellular Ca++ overload and     ventricular dysfunction. Therefore inhibition of late INA has been shown to be     cardioprotective. Ranolazine, an FDA-approval antianginal and anti-ischemic agent, high     selective blocker of late INA, inhibits the late sodium current in myocardial ischemia,     decreases Na+ and Ca2+ overload and improves left ventricular function in experimental animal     models. For this reason it was also adjuncted to cardioplegia improving diastolic function in     isolate Langerdoff-perfused rat hearts. The authors test the hypothesis that ranolazine     improve myocardical protection in patients undergoing coronary artery surgery with     cardiopulmonary by-pass (CPB).   "
45715|NCT02687256|"     This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong     insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.   "
45716|NCT02687243|"     Preoperative anxiety (PA) affects up to 5 million children in North America each year and is     associated with adverse medical, psychological, and behavioral effects. Children who are     highly anxious often require more medications during surgical procedures and take longer to     recover. While many attempts have been made to reduce PA in children, existing interventions     are limited by their expense and time intensive nature. Thus, the current lack of effective     and efficient methods of reducing anxiety in children before and after surgery has prompted     us to develop and propose to test a new intervention. The investigators have developed a     novel,interactive tablet based Virtual Reality program, StoryTelling Medicine (STM), to help     reduce anxiety in children undergoing elective surgery, and its associated negative effects.      STM is an age appropriate, customizable program to prepare children for complex surgical     procedures by guiding them through the hospital settings. The investigators will examine if     STM is effective in reducing PA and its adverse effects in children undergoing surgery. If     effective, STM has the potential to improve children's and families' surgical experiences,     and reduce health problems in the hospital setting and beyond.   "
45717|NCT02687230|"     Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing     PET scans. The study is designed to determine the best time and dose of these agents that     result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for     imaging and a clinical assessment. The last study visit is on day 28.   "
45718|NCT02687217|"     The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound     site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them     received no oxygen during the surgical procedure.   "
45731|NCT02687048|"     Falls have significant consequences for older adults, including fracture, disability, and     death (1). Risk factors for falls include both impaired physical and cognitive function (1).     Thus, older adults with chronic stroke are at significant risk for falls (2).      Exercise is an evidence-based approach for reducing falls risk, even among those who are     living with stroke-related impairments (3,4). More recently, mindfulness based meditation is     gaining recognition for its positive impact on both physical and cognitive health (6,7).     Thus, the investigators hypothesize that combining exercise with mindful meditation may be     greater impact on falls risk reduction as compared with exercise alone. To begin exploring     our hypothesis, we will conduct a 12-week proof-of-concept study among 20 older adults with     chronic stroke (i.e., suffered their first clinical stroke > or = 12 months prior to study     entry). Participants will be randomly allocated to either: 1) exercise; or 2) exercise +     mindfulness based meditation. Outcomes will include measures of mobility, balance, and     cognitive function.        1. Rubenstein, L.. Falls in older people: epidemiology, risk factors, and strategies for          prevention. Age and Ageing 2006; 35-S2: ii37-ii41. doi:10.1093/ageing/afl084        2. Tyson et al. Balance disability after stroke. Physical Therapy January 2006: 86          (1):30-38        3. Thomas S, et al.Does the 'Otago Exercise Programme' Reduce Mortality and Falls in Older          Adults?: A Systematic Review and Meta-analysis. Age Ageing. 2010; 39(6): 681-687.        4. Verheyden G, et al. Interventions for preventing falls in people after stroke. The          Cochrane database of systematic reviews, 2013(5).        5. Baer R. Mindfulness Training as a Clinical Intervention: A Conceptual and Empirical          Review. Clinical Psychology: Science and Practice 2003; 10(2): 125-143.        6. Grossman P, et al. Mindfulness-based stress reduction and health benefits. A          meta-analysis. Journal of Psychosomatic Research, 2004;57(1) 35.   "
45720|NCT02687191|"     This study employs a modified continual reassessment method (mCRM) design to estimate the     maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based     on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes     Bayesian methodology to continuously learn the dose-toxicity relationship, which is     characterized by a parametric model.      Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in     cohorts of 3. The total length of time planned for study participation is approximately 3     months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital     confinement period and follow-up visits through Day 91.      Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according     to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)     version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination     of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day     8).   "
45721|NCT02687178|"     To evaluate the efficacy on blood pressure reduction, safety and tolerability of two     different dosages of canrenone as add-on therapy in patients already treated with Angiotensin     Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics     at the maximum dosage.   "
45722|NCT02687165|"     This study will investigate (a) neural and immune mechanisms underlying chronic pain in PTLS     by comparing a group of PTLS patients and healthy participants on brain imaging, sensory, and     immune markers; and (b) assess change in pain, brain imaging (fMRI and MRS), sensory, and     immune markers in response to a combination of SNRI and glutamatergic treatment for chronic     pain in PTLS (Milnacipran and D-cycloserine).   "
45723|NCT02687152|"     The present project is designed to test the hypothesis that arginase contributes to     microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular     complications.   "
45724|NCT02687139|"     In this study the investigators aim to evaluate diagnostic utility of PSMA-targeted     18F-DCFPyL PET/CT in patients with renal cell carcinoma.   "
45725|NCT02687126|"     The purpose of the study is to evaluate the success rate using ultrasound as guidance during     central venous cannulation in pediatric cardiac surgical patients.   "
45726|NCT02687113|"     The purpose of this study is to determine whether fusion technique of pre-radiofrequency     ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve     feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance     alone.   "
45727|NCT02687100|"     The aim of the study is to test the effectiveness of a solutions of beclomethasone repeatedly     instilled through the supraglottic line of the endotracheal tube on post-extubation airway     disturbances related to tracheal intubation. The primary endpoint will be the decrease of the     incidence of sore-throat 15 minutes and 12 hours after extubation. Secondary endpoints will     regard the effects on hoarseness and cough.   "
45728|NCT02687087|"     The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease     dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck     cancer patients.      A parallel group double blind study design has been selected. The primary outcome is change     in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome     will be compared between Visco-ease and the placebo treatment.   "
45729|NCT02687074|"     Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation     could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital     stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space,     increasing EELV and improving comfort, and it has been used to treat respiratory failure     patients. In recent study, HFNC could improve mortality of respiratory failure patients with     P/F<200mmHg in the subgroup. The investigators want to start a randomized controlled study to     evaluate the effects of HFNC on the patients with respiratory failure.   "
45730|NCT02687061|"     The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis     C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology     laboratories will be explored for registered cases of cHB and cHC. Subsequently the     investigators will compare the registered cases with the list of known cHB and cHC patients     in hospital care. Patients lost to follow up will be informed and approached via either the     Public Health Service (PHS) or their primary care physician. Identified patients will be     invited for re-evaluation at the regional hepatitis centre (The North Western Hospital,     formerly Medical Centre Alkmaar) to assess the current status of their chronic disease.     Evaluation will be performed in accordance with (inter-)national guidelines, no extra     interventions will be performed.      After completion of re-evaluation, a final report will be made and send to both patient and     primary care physician with recommendations for further follow-up.   "
45732|NCT02687035|"     The purpose of this trial is to determine the safety and effectiveness of the Edwards Edwards     SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in     patients with symptomatic, calcific, severe aortic stenosis.   "
45735|NCT02686996|"     The aim of this study is to determine whether carnosine supplementation in overweight/obese     individuals can improve insulin secretion and/or insulin resistance by decreasing sub     clinical inflammation.      The investigators hypothesise that carnosine supplementation will reduce type 2 diabetes and     cardiovascular risk factors by lowering chronic low-grade inflammation (CLI), oxidative     stress, advanced glycation end products (AGEs), and advanced lipoxidation end products     (ALEs).      Aim :To determine the capacity of carnosine supplementation to decrease major risk factors     for type 2 diabetes and cardiovascular disease and identify metabolic pathways involved,     specifically by:        1. Reducing diabetes risk (insulin sensitivity; secretory function and glucose tolerance)        2. Improving cardiovascular risk factors (lipids; arterial (aortic) stiffness; central          blood pressure (cBP); endothelial function).        3. Decreasing the CLI, oxidative stress, AGEs, and ALEs, and increase detoxification of          reactive carbonyl species (RCSs).   "
45736|NCT02686983|"     Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids     is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the     pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and     safety of sub-occipital steroid injections with local anesthetic in patients with chronic     migraine.   "
45738|NCT02686957|"     Obstetric fistula, also called vaginal fistula, is a serious medical condition which affects     women in low income countries. Despite the strengthening of research on fistula, there is     little data on the follow-up after fistula repair.      The objective of this study is to analyse the factors associated with the recurrence of     fistula and the outcomes of pregnancy following fistula repair in Guinea. It will target     women who got a closed fistula at discharge after repair in 2012/2015 at three fistula repair     sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé     Regional Hospital and Jean Paul II Hospital of Conakry).      The outcomes of interest are fistula recurrence and pregnancy. The predictors of interest     will include patient characteristics, fistula characteristics, the context of repair and the     context of reintegration.      Participants giving an informed consent after a home visit by the Fistula Counsellors who     managed women during surgery will be interview at enrolment and every six month from     inclusion. The study duration is estimated at 48 months (January 2012 to March 2016)     including the retrospective part.      A sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2%     margin of error (width of confidence interval is 4%) and 95% confidence interval and is     sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and 10%     precision.      The cumulative incidence rate of fistula recurrence will be calculated using Kaplan-Meier     methods and the risk factor analysis will be performed using adjusted cox regression.      For the outcomes of pregnancy, Pearson's Chi Square (χ2) will be used to compare proportions     of pregnancy outcomes between potential predictors and logistic regression models will be     used and associations will be reported as risk ratios with 95% confidence intervals.      Analysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA)     with a level of significance set at P<0.05.   "
45739|NCT02686944|"     The study is a prospective single armed, open label phase I study. Patients with advanced or     metastatic GIST and tumor progression despite ongoing treatment with second, third or fourth     line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the     study. A maximum of 12 patients will be included in this study. The patients will continue     with TKI treatment until the 3 months follow up visit. If further tumor progression TKI will     be withdrawn but if stable disease or objective response the patient will continue with TKI     until progress. The investigational product Intuvax will be injected into a tumor lesion at     two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and     28 days (±3 days) after the second vaccination (patient 7-12 only). Intuvax will be injected     in a viable part of the tumor, using ultrasound-guided or CT technique for correct     administration.   "
45740|NCT02686931|"     Children with developmental disabilities and children's rehabilitation common case     investigation: Long-term follow-up study.   "
45741|NCT02686918|"     The main of this study is to assess the feasibility of a patients follow-up visit receiving     trastuzumab subcutaneous by Advanced Practice Nurse.   "
45742|NCT02686905|"     The objectives in this study are to provide information on the efficacy of transdermal     supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric     patients, and to determine short-term body composition, HbA1c and fasting plasma glucose     outcomes for patients after bariatric surgery.   "
45743|NCT02686892|"     This is a prospective, observational, multicenter, population-based incidence cohort study     which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 1     year in Spain.      In addition, each incident case that gave his/her informed consent, will be followed up for     12 months to determine changes in phenotype or disease location, the need for     immunosuppressive and biologic treatments, and the need for hospital admissions and surgery     during the first year after diagnosis.   "
45744|NCT02686879|"     Hyperopia, also known as farsightedness, is a common type of refractive error where distant     objects may be seen more clearly than objects that are near.      Hyperopia is a known risk factor for amblyopia, (lazy eye), which may occur as a result of a     squint (turn), or due to different levels of hyperopia between each eye (anisohyperopia).      Hyperopia and anisohyperopia often persist into adulthood resulting in impairment to     binocular vision. Current management involves prescribing spectacles or contact lenses to     correct the hyperopia in each eye, usually as a lifelong intervention.      In recent years there has been a great deal of interest in delaying progression of myopia     (short-sightedness) by slowing down the growth of the eye using a particular type of contact     lens termed a centre-distance multifocal design. There have been some encouraging results in     this area to date.      The proposed study here would explore the use of centre-near multifocal design contact lenses     to encourage growth of the eye, thereby reducing hyperopia. There are three elements to the     programme of research:        1. The natural progression of axial growth and refractive error will be measured in          hyperopic and anisohyperopic subjects aged between 5 and 19. In other words, the natural          growth of the eye will be followed without any intervention        2. As a paired eye control study anisohyperopes aged between 8 and 15 will be fitted with a          centre-near multifocal design contact lens in their more hyperopic eye and a single          vision contact lens in the fellow eye, if required. The progression of axial growth and          refractive error will be measured and compared in each eye        3. Subjects' aged between 8 and 15 with similar levels of hyperopia in each eye will be          fitted with centre-near multifocal design contact lenses in each eye. The progression of          axial growth and refractive error will be measured and compared to subjects in the          natural progression study   "
45745|NCT02686866|"     Feeding optimization and nutritional assessment in patients with severe heart failure are     challenging. The prevalence of cardiac cachexia may be underestimated by simple measurements     of body weight and body mass index because many patients show relative reductions in muscle     mass despite being of normal overall weight. Body composition measurement can be essential in     chronic heart failure (CHF) patients to estimate sarcopenia. Chronic heart failure patients     with cardiac cachexia have a mortality two to three times higher than noncachectic patients.     Bedside body composition measurements can reveal developing cardiac cachexia hence can be     useful in prevention.   "
45746|NCT02686853|"     The main purpose of this study is to observe the clinical effect of intrathecal     administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune     Deficiency Syndrome (AIDS).   "
45748|NCT02686827|"     Low Vitamin D3 (VD3) levels have been reported to be associated with the risk of allergic     diseases like asthma. VD3 has been demonstrated in vitro, ex vivo and in animal models to     program the immune system towards anti-inflammatory immune responses. VD3 co-administered     with allergen may be a promising adjuvant to improve the onset and efficacy of allergen     immunotherapy (AIT). A clinical trial will be performed to compare the immune effects, the     tolerability and safety of multiple doses of aVD3 analogue (registered for the intravenous     route) administered by the subcutaneous (s.c.) route in subjects with allergic rhinitis and     healthy controls.      The overall aim is to provide additional (in vivo) support for the use of VD3 as an adjuvant     in allergen-specific immunotherapy, on top of the existing pre-clinical evidence     demonstrating that antigen-presenting cells educate the adaptive immune system towards an     anti-inflammatory response when allergen is seen in the presence of VD3.   "
45749|NCT02686814|"     The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215     aortic valve bioprosthesis.   "
45750|NCT02686801|"     This study evaluates the perinatal factors influencing body composition at discharge in very     preterm infants and the relationship between fat free mass and further neurocognitive     development.   "
45841|NCT02685605|"     INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical     phase III trial which tests if the median progression-free survival (PFS) of patients with     newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of     intraoperative radiotherapy (IORT) to standard radiochemotherapy.   "
45755|NCT02686736|"     The objective of this study is to design and evaluate an internet-based educational strategy     to prevent sexual risk behaviors in Mexican adolescents. Methods: A field trial with one     intervention and one comparison group, with ex-ante and ex-post measurements will be     conducted in 2 public secondary schools. Adolescents between 14 and 15 years of age will     participate. The intervention will be conducted in one school and the other school will serve     as a comparison group, where investigators will observe the usual sexual education that the     school provides. The intervention will be delivered through an internet web page; it includes     four educational sessions that will be provided during a four-week period. The follow up will     last three-months. The information on the study variables will be obtained through an     internet-based self-applied questionnaire and collected on three occasions: when the     adolescents enters to the study (baseline), once intervention is completed (at one month) and     after three months of follow-up (at fourth month).   "
45756|NCT02686723|"     Comparison of two groups of subjets (ACL injury who return to sport) and control group     non-injured about clinical and biomechanical data :        -  clinical test        -  functional test        -  motion analysis of 2 sport exercises        -  tibial translation        -  isokinetic evaluation   "
45757|NCT02686710|"     Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving     either volatile or intravenous anesthesia   "
45758|NCT02686697|"     This is a double-blind placebo-controlled trial to evaluate the effects of the combination of     a cognition enhancing drug, i.e carnosine, with cognitive training in patients with     schizophrenia. All participants will receive the same cognitive training sessions and will be     randomised to either carnosine or placebo for the duration of the combined treatment period     (2 weeks). Before combined training and carnosine/placebo, there is a two-week     carnosine/placebo only phase to examine the effects of carnosine alone on functioning without     training.   "
45759|NCT02686684|"     The primary aim of this study is to explore the effect of dimethyl fumarate on gray matter     (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in     patients with relapsing multiple sclerosis (MS). The secondary objective of this study is to     investigate the effect of dimethyl fumarate on evolution of microstructural changes in normal     appearing white matter (NAWM), as measured by DTI.   "
45771|NCT02686528|"     The purpose of this study is to determine if hip precautions, which are instructions that     limit functional use of a hip replacement after surgery, affect the rate of dislocation in     the first six weeks after primary total hip replacement surgery. The impact of hip     precautions on a patient's return to activities of daily living and overall patient     satisfaction will also be investigated. The overall cost effectiveness of hip precautions     will be determined.   "
45772|NCT02686515|"     The objective of this study is to investigate the effect of dual-task training at impairment,     disability, and participation levels for stroke survivors and investigate possible factors     affecting cognitive-motor interference (CMI) under dual-task conditions. Specifically, we     will compare the immediate and retention effects of dual-task balance training and     single-task balance training on CMI, balance confidence, fall rate, functional performance,     and quality of life in individuals with stroke (Aim 1). The second aim of this study is to     explore how lateralization, stroke chronicity, task type, and task difficulty may influence     patterns of CMI (Aim 2). The third aim of this study is to investigate whether dual-task     balance assessments are more sensitive than single-balance assessment in distinguishing     stroke fallers from stroke non-fallers (Aim 3).   "
45760|NCT02686671|"     Shoulder pain is very common. People receive injections in their shoulder for their painful     shoulder. However, investigators do not know which patient with shoulder pain responds best     to an injection in the shoulder.      Investigators plan to use a Pull Test where the researcher will pull on the arm and resist     shoulder movement to investigate if it helps to determine which patients have better pain     relief with the shoulder injection.      The study will take place in Anchorage, Alaska. There will be two phases in the study. For     each phase, the subjects will complete some questionnaires. Phase I Reliability Testing     will test how consistent two licensed physical therapists are giving shoulder examination     tests and the Pull Test. Phase II Pull Test will comprise shoulder examination findings,     including the Pull Test, done before and after one shoulder injection performed as normal     standard of care by a licensed physician.      For Phase I of the study, up to 20 patients treated for shoulder pain will be recruited from     Advanced Physical Therapy. For Phase II of the study, up to 100 patients with shoulder pain     scheduled to have a shoulder injection will be asked by an investigator if they wish to     participate in the study until a number of 30 subjects qualify for the study. Phase II of the     study will include shoulder tests before and about 20 minutes after the injection and a 4- to     7-day, as well as a 6-week, phone follow-up.      Statistics will be used to analyze the data.   "
45761|NCT02686658|"     The objectives of this study are to evaluate the safety and efficacy of intravitreous     administration of Zimura® when administered in subjects with geographic atrophy (GA)     secondary to dry age-related macular degeneration (AMD).   "
45762|NCT02686645|"     Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of     fecal microbiota therapy (FMT) in the investigators population.   "
45763|NCT02686632|"     Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal     mucosa. It is the most prevalent oral disease and the main indicator of poor oral health     among denture wearers, affecting one-third of all complete denture wearers.      The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and     fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However,     the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy     is common.      The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing     in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of     change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6     months.   "
45800|NCT02686138|"     This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will     evaluate the safety and efficacy of one dose of Tenapanor in subjects with     constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria     and who have active disease as determined after a two-week screening period. Subjects who     qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for     a 26 week treatment period.   "
45764|NCT02686619|"     This multicentre, prospective, randomized, open-label study will compare the safety and     efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation     of cyclosporine, with those of mycophenolate mofetil and long term continuation of     cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction     treatment and followed by 8 month treatment with corticosteroids. The anticipated time on     study treatment is 12 months. Participants who will complete the initial 12-month study and     who will provide written informed consent will be eligible to participate in a 60-month     follow-up phase.   "
45765|NCT02686606|"     Patients with short bowel intestinal failure are recommended to aim for a diet high in energy     and protein. Some patients have difficulties in achieving recommended intakes and additional     nutrition may be provided by oral nutritional supplements. There is very little research     completed on which is the best oral nutritional supplement for patients. The aim of the study     is to see the effect different oral nutritional supplements have on your stoma or fistula     output and levels of hydration.   "
45766|NCT02686593|"     The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML     when used as first salvage for patients to relapse or fail after standard treatment with     daunorubicin/cytarabine induction.   "
45767|NCT02686580|"     This study is designed to assess the effectiveness of porcine cross-linked collagen paste for     the treatment of patients with ano-rectal abscess with underlying cryptoglandular fistula in     ano.   "
45768|NCT02686567|"     The rate of anastomotic leakage after laparoscopic anterior resection（LAR） for medium & low     rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for     deduce the rate. There were several studies, but most of them were not randomized controlled     trial (RCT) studies. There was only one RCT study with enough samples, but it was designed     for open anterior resection, and the patients underwent diverting stoma were excluded, so     there was the selection bias. LAR now is thought to been with the same effect, and it is safe     and feasible. So a RCT investigation for the use of TDT for prevention of anastomotic leakage     after LAR for medium & low rectal cancer is needed.   "
45769|NCT02686554|"     At the time of biomarker-substantiated diagnosis for a given AD patient it remains unclear to     what extent the disease will devastate cognitive abilities within the next years. This is not     only unsatisfying for the patient and the attending physician but also a major problem in the     context of clinical trials that aim to establish new therapeutic agents. In clinical trials     it is critically important to foresee as precisely as possible the course of the disease. The     overall aim of the subproject is to identify a panel of CSF biomarkers to further improve     specificity of diagnosis (disease markers), to measure disease activity and to predict AD     progression (stage and progression markers).   "
45770|NCT02686541|"     The aim of this study is to study the effects of athrectomy followed by percutaneous     transluminal angioplasty using Paclitaxel coated Drug Eluting Balloon (DEB) in treating de     novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic     peripheral vascular disease in an Asian population. The intention is to study the effects of     debulking athrectomy followed by application of DEBs to prevent restenosis, resulting in     improved patency rates The study will prospectively recruit 8 cases treated with athrectomy     followed by DEB. This project is a pilot to investigate the effects of athrectomy and DEB in     reducing re-stenosis rates. It will be a primer for a larger scale randomized controlled     trial (RCT) involving multiple institutions to demonstrate the benefit of athrectomy and DEB     technology to treat de novo versus plain balloon angioplasty with bail-out stenting, which is     currently the most commonly used modality to treat femoral-popliteal lesions. There are no     studies combining the effect of rotational athrectomy and DEBs.   "
45773|NCT02686502|"     This study evaluates the effect and usability of mobile and cloud technology -based     intervention on lifestyle modification in 18-40 year obese and overweight subjects.      The study has a dose-response design with three randomized subjects groups from Mode 1 to     Mode 3 with increasing intensity of intervention (guidance, exercise program, diet, support).     The special focus of this study is on motivation and use of music and mobile health devices     as motivational tools to support individualized exercise training, healthy diet and overall     healthy life style.   "
45774|NCT02686489|"     The goal of the study is to compare the safety and efficacy of molecular water and bland     aerosol therapy (particulate water) in providing adequate humidity to the inspired gas of     spontaneously breathing tracheostomy patients.   "
45775|NCT02686476|"     Fatty liver disease is an increasingly recognized health problem in patients with type 2     diabetes mellitus (T2DM). Sodium glucose co-transporter type 2 (SGLT-2) inhibitors are a new     class of anti-diabetic agents that cause weight loss by inducing glycosuria. The effect of     SGLT-2 inhibitors on liver fat content is not evaluated. Empagliflozin is an orally active,     selective inhibitor of SGLT-2. We hypothesized that Empagliflozin, when added to standard     care for T2DM, would improve fatty liver disease. Therefore, the present study is planned to     evaluate the effect of Empagliflozin on the liver fat content.   "
45776|NCT02686463|"     This trial is designed to compare diagnostic and therapeutic effects of laparoscopy vs.     laparotomy on early malignant ovarian cancer, and to evaluate the efficacy and safety of     laparoscopy in early malignant ovarian cancer.   "
45777|NCT02686437|"     The purpose of this study is to determine the effectiveness of standard tension of     Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain,     disability, and recovery speed during an in-office rehabilitative program. A convenience     sample size of 38 new patients with current shoulder pain will be recruited for this study.     The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder     Score (PENN). After completing the initial paperwork, patients will be randomized into two     groups, control (0% tension) and intervention(increasing tension). At the beginning of each     week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4     weeks patients will complete the PENN.   "
45801|NCT02686125|"     To compile characteristics of real-world outcomes of Boston Scientific Corporation's     commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of     dystonia.   "
45802|NCT02686112|"     The study aims to quantify the relations between first & second trimester bleeding and     maternal & neonatal morbidity. Additionally, the study will help in assessing the risk for     abortions in women with threatened abortions and the risk factors for threatened abortion.   "
45778|NCT02686424|"     Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Despite     advances in therapeutic intervention, the mortality from this disease remains high. As a     result, most patients are now offered varying combinations of surgery, chemotherapy, and     radiation therapy in order to derive benefits from a multidisciplinary approach.     Unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary.     Thus new therapeutic strategy is required for the treatment of gastric cancer.      In the early 1980s, the discovery of cytolytic T cells (cytolytic T lymphocytes, CTLs)     directed against an antigen presented on tumor cells was published. They can kill many     invasive cells by recognizing the tumor specific antigens on the major histocompatibility     complex (MHC) molecules. It is now generally agreed that although tumors express tumor     antigens, they usually lack immunogenicity because of their inability to activate the immune     response. The current view is that tumor cells are antigenic, but not immunogenic. If we can     artificially activate the immune system against the tumor, it may be possible to eradicate     the tumor. This approach is the basis of cancer immunotherapy.      Many tumor antigens have been defined in terms of multiple solid tumors: MART-1/Melan-A,     gp100, carcinoembryonic antigen (CEA), HER-2, mucins (i.e., MUC-1), prostate-specific antigen     (PSA), and prostatic acid phosphatase (PAP) are just a short list. Some immune-based     therapies targeting these tumor antigens are in phase III trials assessing whether immunizing     against these antigens affects overall survival. In gastric cancer, some tumor antigens such     as MAGE-A3, NY-ESO-1, and WT-1 have been reported to be expressed in substantial proportion     of cases. They have the potential to be the targeting molecules for immunotherapy in the     future. In this study, we aim to explore the expression levels of the four tumor markers     (MAGE-A3, NY-ESO-1, WT-1 and PRAME) in gastric cancers of Korean patients and to examine the     correlations of the expression levels of the four markers to clinic-patholoical factors.   "
45779|NCT02686411|"     Objectives:      Primary Objective:      To determine the change of satisfaction with quality of care after an experience on the     Palliative Care Unit (PCU) for both patients and caregivers, as determined by the global     rating survey.      Secondary Objectives:        1. To determine the change of the quality of care as determined by patients and caregivers          utilizing validated assessment tools and global rating survey assessing different          aspects of care after PCU.        2. To determine domains of care that are strongly or poorly provided by the PCU, as          reported by patient and caregiver opinions on quality of care.        3. To determine which demographic features (i.e. cancer diagnosis; time since diagnosis;          reason for transfer to the PCU; gender; caregiver ethnic group; comfort with the idea of          transfer to the PCU; Memorial Delirium Assessment Scale (MDAS), Edmonton Symptom          Assessment Scale (ESAS) and distress thermometer) may correlate with patient and          caregiver relative satisfaction with PCU care measured by global survey and with the          Family Satisfaction with End-of-Life Care.   "
45780|NCT02686398|"     During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study.     The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted     vaccine group) and were immunized with the respective vaccine. Sera were collected prior to     vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI)     antibodies were measured.   "
45781|NCT02686385|"     Intervention - Subjects will be randomized to 2 groups      Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)      Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing      Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1     hour      Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h      Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h        -  Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test          at regular intervals.        -  Stopping rule-Development of sepsis, worsening of Liver functions.   "
45782|NCT02686372|"     Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while     treatment measures are limited. This study plans to recruit 10 subjects with Hepatitis B     virus (HBV) related HCC after liver transplantation. The objective of the study is to assess     the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR)     redirected T cell in the target population.   "
45783|NCT02686359|"     If epidemiological studies indicate relatively low prevalence reported in the general     population, idiopathic burning mouth syndrome (BMS) is a common condition among certain     groups of the population: 30% of menopausal women experience oral burning to varying degrees     . Despite significant progress made in recent years, in understanding the physiopathogeny,     treatment options remain limited and disappointing,resulting in an impairment of the quality     of life. Given the chronic nature of idiopathic burning mouth syndrome, the need to identify     the causes and effective treatment modalities for subjects suffering is essential.   "
45784|NCT02686346|"     This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation     design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin     in Hodgkin lymphoma patients treated with ICE regimen.      The second part, depending on the selected dose after the completion of phase Ib part of the     study, will further explore safety in addition to efficacy of the recommended dose of     Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin     lymphoma.   "
45785|NCT02686333|"     This study examines the use of brief meditation interventions for patients with symptoms of     anxiety and depression who are undergoing dialysis. Half of the participants will receive     meditation interventions 3 times a week, while the other half will receive treatment as     usual. This study will examine whether meditation is feasible and whether it has any effect     on reducing symptoms of anxiety or depression.   "
45786|NCT02686320|"     Rheumatoid arthritis (RA) is associated with a higher prevalence of infections, malignancies,     osteoporotic fractures and cardiovascular diseases. Few data are available regarding the     prevalence and severity of these comorbidities in elderly RA patients. The purpose of this     study is to determine the effect of age on prevalence and severity of comorbidities in RA.   "
45803|NCT02686099|"     The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a     cerclage material into a single sternal closure system. The cerclage material serves to     facilitate sternal approximation, and the plates and screws serve to provide rigid fixation     and prevent sternal movement and separation. The combination of a cerclage material in     combination with plate and screw fixation may also lead to increased stability compared to     either method used as a standalone means of closure.   "
45854|NCT02685436|"     Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined     multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid     laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux     esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and     exacerbations recurrence.   "
45787|NCT02686307|"     During tachyarrhythmias, central venous pressures increases while arterial blood pressure     (BP) decreases. The result is mixed messages to the central nervous system. On one hand, the     unloading of the arterial baroreceptors results in reflex tachycardia and an increase in     sympathetic nerve activity (SNA). On the other hand, the increase in filling pressure and     thus the activation of the cardiopulmonary baroreceptors result in reflex bradycardia and     sympathoinhibition. The investigators have previously shown that during supraventricular and     ventricular tachycardia, arterial baroreflex gain (BRG) predominates with minimal     contribution from the cardiopulmonary BRG. In addition, the investigators found that arterial     BRG directly correlates with BP recovery following tachycardia termination. The roles of the     arterial and cardiopulmonary BRGs during ventricular fibrillation (VF) however, remain     unknown. Furthermore, the role of the arterial BRG in determining 1) BP recovery following VF     induction and 2) the frequency of ventricular tachycardia (VT)/VF events in patients     undergoing implantation of an implantable cardioverter/defibrillator (ICD) remain unknown.     Analysis of the changes in sinus node cycle length during VF inductions in patients     undergoing the implantation of a dual chamber or triple chamber ICD, provide a unique     opportunity at looking at the autonomic changes that accompany VF.   "
45788|NCT02686294|"     The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine     after multiple oral administration of TALION tab., a IR formulation of bepotastine as     reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male     adults. Additionally the safety and tolerability of two drugs will be evaluated.   "
45789|NCT02686281|"     The purpose of this study is to determine the toxicity, tolerability and safety of single     ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.   "
45790|NCT02686268|"     This research study is being performed to better understand a specific form of Amyotrophic     Lateral Sclerosis (ALS) caused by a mutation (or abnormality) of the C9ORF72 gene. This     mutation is the most common genetic cause of ALS, and is present in 40% of ALS patients with     a family history of ALS and 5-10% of ALS patients without a family history of ALS.   "
45791|NCT02686255|"     Many toddlers and children are released home with relatively low hemoglobin levels following     cardiac surgery, and with no careful follow up, at an age at which anemia is common. At this     age, breast milk and its substitute do not provide enough iron, and parents are not adherent     enough to iron supplements. Due to these facts, there is high importance, especially in     children suffering from heart defects, for close follow up on their hemoglobin levels.     Studies following hemoglobin trend post cardiac surgery were never done with children.   "
45792|NCT02686242|"     Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of     hemorrhage, most parturients with placenta previa have to accept cesarean section. In this     study investigators compare the effect of different anesthetic techniques on these patients.   "
45793|NCT02686229|"     The LoG-Glio-Registry is based on a network of german hospitals gathering radiological,     clinical, epidemiological and molecular data on all patients diagnosed with a low grade     glioma.   "
45794|NCT02686216|"     Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease     patients and healthy subjects.   "
45795|NCT02686203|"     evaluating The Investigational Therapy effects on quality of life, pain and patient's     clinical status in adult cancer patients with solid tumors who are no longer candidates for     active oncological therapies.   "
45796|NCT02686190|"     Background: Management of patients with Alzheimer's disease associated with behavioral     disturbances is difficult especially in those with agitation/aggression and insomnia and     nighttime behaviors. No treatment has shown any efficacy to control these disturbances and     psychotropics drugs, i.e. sedatives and hypnotics have numerous adverse effects.      Objective: Assess the effect of bright light therapy on behavioral disturbances of patients     with Alzheimer's disease, especially the effect on agitation/aggression and insomnia and     nighttime behaviours.      Study design: Multicenter non pharmacological intervention trial, controlled, randomized,     open, two-arm design : control group and intervention group.      Centres : Rehabilitation and long term-care units of 4 geriatric hospital wards.      Patients: 120 patients admitted in geriatric hospital wards (30 by centre), with probable     Alzheimer's disease according to DSM-IV diagnosis criteria and agitation/aggression     (associated or not with insomnia or nighttime behaviors) according to the Neuropsychiatric     inventory, nurse scale (NPI-nurse).      Treatments: Intervention group: patients will participate in a program of bright light     therapy realised during a one-hour sessions of occupational therapy,. These sessions will be     realised for groups of 6 patients and will be done every week day, at late morning, for 4     consecutive weeks). During the session, patients will be exposed to 10000 lux-bright light.     Patients of control group will participate in a program of occupational therapy of same     duration and rhythm, realised in standard light conditions (about 300 lux).      Assessment: Patients with be assessed on 3 occasions: inclusion, two and four weeks after the     beginning of the programs. Assessment will comprise ; NPI-nurse scale and Cohen-Mansfield     scale for behaviour disturbances, wrist actimetry for sleep and nighttime behaviours (total     sleep length, nocturnal wake episodes and nocturnal motor agitation).      Judgment criteria: Principal: changes in the agitation/aggression item of NPI-nurse scale.     Secondary: changes of the nightime behaviours item of NPI-nurse scale, the Cohen-Mansfield,     total sleep duration and numbers of nocturnal wake episodes measured by wrist actimetry.      Statistics: Changes in agitation/aggression scores od the two groups will be compared by Mann     and Whitney test.      Expected results and perspectives; If bright light exposure is efficient, professional     caregivers of Alzheimer's disease patients might apply this cheap and non pharmacological     approach to improve behaviour and sleep of these patients. This study might contribute to     better define the place of a non invasive and promising technique, wrist actigraphy, to     assess sleep and behaviour disturbances in psychogeriatric patients   "
45797|NCT02686177|"     GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their     efficacy is documented. However, safety aspects are also important to evaluate with respect     to micro and macrovascular complications associated with T2D. Few studies have properly     addressed the role of GLP-1-based therapies in regulating vascular integrity and     angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2     and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in     type 2 diabetic patients.   "
45798|NCT02686164|"     This is a multicenter, open-label, non-randomized Phase 1 study in participants with advanced     solid tumors, excluding hepatocellular carcinoma (HCC), that have progressed after treatment     with approved therapies, or for which there are no standard therapies available. The study     will also include participants with radioiodine-refractory differentiated thyroid cancer     (RR-DTC). Its primary intent is to determine the effect of lenvatinib on CYP3A4 activity as     well as to assess the safety and activity of lenvatinib in these participants. The study will     be conducted in the following 3 phases: Pretreatment Phase, Treatment Phase, and Extension     Phase.   "
45799|NCT02686151|"     To investigate the effect of letrozole in patients who have high risk of ovarian     hyperstimulation syndrome (OHSS) after oocyte retrieval, the incidence of OHSS were     calculated between letrozole group and supporting treatment group.   "
46729|NCT02673983|"     The aim of this study is to evaluate FTRD (full-thickness resection device) in terms of     obtaining full-thickness biopsies form the gastrointestinal tract endoscopically in the     work-up of patients with gastrointestinal motility disorders.   "
45804|NCT02686086|"     Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of     inhalation therapy. The response to treatments is dose dependent thus applying the most     efficient device to administer the treatment is integral. Evaluation of the efficacy of     nebulisation devices in the treatment of COPD is limited. Technological development in recent     years has led to new devices that optimize lung deposition and reduce the time needed for     treatment.      The aim of this study is to compare the vibrating mesh and jet nebuliser methods of     delivering bronchodilator medication to patients hospitalised with an acute exacerbation of     COPD, with respect to lung function and efficacy in spontaneously breathing patients.   "
45805|NCT02686073|"     Study the rate of progress of labor among nulliparous women belonging to different body mass     index groups, & observe how does this variation in maternal body mass index may affect the     course of labor.   "
45806|NCT02686060|"     While venous access is an essential part of caring for the preterm neonate potential severe     adverse events, including contamination of fluids with bacteria, endotoxins and particulates     could occur (Bethune 2001).      Infusion therapy carries a risk for catheter-associated septicaemia (Geiss 1992) originated     from the catheter tubing, the ports, at the cannula site or from contaminated infusion fluid.     While not all infections lead to septicaemia, immuno-compromised patients such as neonates     are at greater risk, and infection becomes a major problem (Ng 1989) and a major risk factor     for neurodevelopmental disabilities (Volpe 2008). Indeed, it has been postulated that     endotoxins may be involved in the pathogenesis of a proportion of cases of periventricular     leukomalacia, the most frequent brain damage associated with neurocognitive handicaps in the     human neonate (Volpe 2001).      The presence of calcium in parenteral nutrition mixture leads to precipitation due to its     incompatibility with the other components of the admixtures and leads to high concentration     of particles (Athanasiou 2014). Adverse systemic effects of particulate matter including     phlebitis, granulomata formation in the lung (Marshall 1987) and ischaemic necrosis, are a     common finding in necrotizing enterocolitis another serious complication flowing preterm     birth (Ballance 1990). Particle contamination of infusion solutions exists despite a     stringent infusion regiment. The number and composition of particles depends on the     complexity of the applied admixtures (Jack 2010).      Particulate contamination is due to drug incompatibility reactions or their incomplete     reconstitution during the preparation process (Schroder 1994). Various studies have     demonstrated the contamination of infusion solutions with glass particles from opening glass     ampoules, particles from rubber stoppers or conglomerates of the parenteral nutrition     components (Ball 2003). Particles have also been shown to be inherent to generic drug     formulation (Oie 2005). In an intensive care setting the particle burden may rise up to one     million infused particles per day, increasing with the complexity and quantity of the     administered infusions (Walpot 1989).      There are two main IV filter pore sizes; the 0.2 micron filter is used for aqueous solutions,     and the 1.2 micron filter is recommended for larger molecule solutions such as lipids. The     0.2 micron filter has also been reported to remove air, microorganisms and particulate     matter. In addition, endotoxin retention is reportedly achieved by using a positively charged     filter membrane; toxic macro-molecules are released by gram-negative bacteria and are claimed     to be effective for up to ninety six hours (Bethune 2001).      In-line IV filters are currently claimed to be an effective strategy for the removal of     bacteria, endotoxins and particulates associated with intravenous therapy in adults (Ball     2003) and particularly effective in the removal of particles caused from drug precipitate     such as antibiotics (Chee 2002; Ball 2003).      However, evidence of the beneficial effect of in-line IV filters in children and neonates is     much weaker, despite some positive studies (Jack 2012; Boehne 2013; Sasse 2015). In the     population of preterm infants, no study is currently available while particulate     contamination due to infusion therapy carries a higher health risk in this subpopulation.      The benefits of using IV in-line filters in critically-ill preterm neonates remains to be     demonstrated. This intervention in adults has also been challenged by several authors     (Pearson 1996; Newell 1998). Friedland reported that certain drugs such as antibiotics may be     retained in the filters causing a reduction in potency (Friedland 1985). On the other hand,     there are no known adverse effects from the use of IV in-line filters.   "
45807|NCT02686047|"     Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA).     There is no well controlled trial comparing one injection regimen of HA for the treatment of     knee OA. The purpose of this study was to compare the efficacy and safety of one     intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the     treatment of knee OA.   "
45808|NCT02686034|"     This study is a prospective, multi-centre, randomised, double-blind, sham-controlled     investigation designed for comparison of two parallel treatment groups: gammaCore (active     nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine     attacks   "
45809|NCT02686021|"     Postoperative pain is common and particularly outpatients may experience unsatisfactory pain     relief. This randomized, double-blind, crossover study of postoperative pain in outpatients     undergoing split-mouth, third lower molar extraction aims to examine whether or not the     combination of metamizole and ibuprofen is superior to either drug alone.   "
45810|NCT02686008|"     This is an open label pilot study evaluating the pharmacodynamics and safety of single agent     olaparib administered at 300mg bid (twice a day) for 14 days orally in patients with human     papillomavirus (HPV) -positive and human papillomavirus (HPV)-negative head and neck squamous     cell carcinoma (HNSCC)   "
45811|NCT02685995|"     Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled     dialysis catheters.   "
45819|NCT02685891|"     In this study, the investigator evaluates whether there are age-specific diurnal changes in     markers of cortical plasticity in children, adolescents and adults. The question will be     investigated by the quantification of brain metabolites and structural brain volumes using     magnet resonance imaging (MRI) and electrophysiological markers using sleep encephalography     (sleep EEG). In a second step, it will be tested how these markers of cortical plasticity     change depending on a modulation of sleep by applying tones during deep sleep.   "
45820|NCT02685878|"     The purpose of this study is to describe the long-term surgical success, quality of life,     prevalence of depression, fertility rates, and pregnancy outcomes of patients who have     undergone obstetric fistula repair.      This will be a study involving up to 300 women 1-3 years after they have undergone obstetric     fistula repair at the Fistula Care Center in Lilongwe, Malawi.      Patients who underwent obstetric fistula repair between January 1, 2012 and July 31, 2014     will be identified from an existing database of fistula patients. They will then be contacted     and invited to participate in the study. Consented patients will complete a 1-hour pad weight     to evaluate urinary continence, a demographic questionnaire, an incontinence-related quality     of life metric, and a depression metric. The data will be analyzed and then disseminated to     stakeholders.   "
45812|NCT02685982|"     Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with     persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced     social functioning, and impaired quality of life. MDD is estimated to affect approximately 2%     of Canadian women and 1% of Canadian men at any point in time. The World Health Organization     affirms that depression is the leading cause of disability worldwide, with increasing global     economic impact.      Standard treatments for depression include basic psychosocial support combined with     antidepressant medication or psychotherapy. It has been observed, however, that only 50% of     individuals respond to psychological treatment, and only 30-40% of patients achieve full     remission after initial treatment with antidepressants. Music- and sound-related therapies     have the potential to serve as adjuncts to, or facilitators of, medication.      In this study we will examine the effectiveness of a new therapeutic tool, known as Rhythmic     Sensory Stimulation, as an adjunctive treatment for Major Depressive Disorder. Rhythmic     Sensory Stimulation is a non-invasive brain stimulation technique that uses periodic pulses     of light, sound, or tactile stimulus, to induce changes in the patterns of brain activity.     Participants in this study will undertake 30 minutes of daily music intervention     self-administered at home, for 5 days per week, for a total of 5 weeks. We will assess     depression symptoms, sleep quality, quality of life, and brain activity pre- and     post-treatment.      The results of the present study will help to better understand the effectiveness of Rhythmic     Sensory Stimulation to the treatment of mood disorders, and contribute to the development of     future studies to investigate the neural driving effects of therapies based on Rhythmic     Sensory Stimulation.   "
45813|NCT02685969|"     Study to understand factors related with the preclinical stages of Alzheimer's Disease and     investigate markers that predict its progression.      Cross-sectional and single arm study performed on a subgroup of individuals recruited in the     ALFA project.      Study without therapeutic interest for the research participants (440 participants of the     ALFA project who have been selected for being cognitively healthy and in their vast majority     are direct descendants of patients diagnosed with Alzheimer's Disease).      Each study candidate will be selected from the ALFA project (STUDY 45-65 FPM/2012) according     to their clinical characteristics, their compliance to selection criteria and their desire to     participate in this study.      After signing this study's specific informed consent form, the neuropsychological screening     and the brain MRI acquisition will be performed. Once all inclusion criteria are checked, the     PET scans with 18F-Flutemetamol and 18F-FDG will be performed   "
45814|NCT02685956|"     The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative     PCR Test. Precision of results and concordance of results with a reference assay will be     evaluated.   "
45815|NCT02685943|"     Although suicide risk is highly prevalent among the patient population in mental health care,     remarkably little research exists on effective treatments. Among a small set of novel     approaches, CAMS is particularly promising. The investigators compare CAMS to TAU in a     randomized controlled trial at four departments in Vestre Viken Hospital Trust, hypothesizing     CAMS to be the superior approach. Primary outcome measures are suicidal ideation and suicide     attempts, with secondary outcome measures including general symptoms of mental health     problems. Changes in the outcome measures are compared between the two groups from baseline     to 6 and 12 months after patients are included in the study. The study has the potential to     impact the science of treating suicidal individuals and it could benefit the general public     by establishing CAMS as an effective clinical approach for rapidly reducing suicide risk.   "
45816|NCT02685930|"     The purpose of this observational study is to collect prospective data on the occurrence of     bacterial and viral pneumonia in the ICU setting. Current classification systems for     pneumonia promote over treatment with antibiotics as they do not specifically recognize the     presence of culture-negative and viral pneumonia. The investigators will collect data to     determine if a novel pneumonia classification system can be developed that more accurately     links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia,     antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to     clinical outcomes. Additionally, the investigators will collect data on the practice of     antimicrobial stewardship in the ICU setting to determine if further improvements in     antibiotic practices can be accomplished in the future.   "
45817|NCT02685917|"     The quality of cartilage regeneration after marrow stimulation is well documented to be     unpredictable, because they do not regenerate consistent amount of cartilage. To overcome the     shortcomings of the microfracture technique, various augmentation techniques using synthetic     collagen matrix, scaffolds or plug devices have been developed. However, their efficacy     remains unclear. The purpose of this prospective randomized controlled study is to evaluate     whether the microfracture in combination with collagen gel augmentation could improve the     quality of cartilage regeneration in patients undergoing medial open wedge high tibial     osteotomy (HTO) for the treatment of medial unicompartmental knee osteoarthritis (OA).   "
45818|NCT02685904|"     This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to     evaluate the efficacy and safety of ENIA11 in patients with ankylosing spondylitis. The study     period for each patient will be 27 weeks, during which the patient will undergo screening for     up to 21 days, and followed by treatment of 24 weeks and follow up period of 2 weeks. Each     patient will be required to make a total of 9 visits.      After re-confirming the eligibility of patients at Visit 2, eligible patients will be     randomly assigned to either treatment group or control group in a 2:1 ratio. In addition,     patients in the treatment group will receive ENIA11 25 mg twice weekly by subcutaneous     injection while patients in the control group will receive placebo solution twice weekly by     subcutaneous injection from Day 0 to week 12 and then switch to active drug from week 12 to     week 24 and follow up period of 2 weeks.      The efficacy analysis, including ASAS response measures, ASAS5/6, ASDAS, BASDAS, BASFI, BASMI     and individual measures of disease activity, such as numbers of swollen and tender joints,     ESR and CRP, will be evaluated at each visit from Visit 2 (baseline) to Visit 9. Safety will     be evaluated according to the frequency of adverse events, vital signs, physical examination,     laboratory abnormalities, and ENIA11 antibody formation.   "
45821|NCT02685865|"     The research design is a randomized prospective clinical trial comparing Endoscopic     ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be     conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.   "
45823|NCT02685839|"     Elderly care has become one of the most important subjects in Taiwan and frailty syndrome     are the most common problems among the elderly. In view of this trend, Taipei Veteran     Memorial Hospital imported POWER rehabilitation from Japan in 2008. While showing significant     clinical benefits, investigators have found that the system still has certain limitations     (e.g. high cost, requires large space, patients must commute to the center, lacks real-time     objective feedback , boring routines makes staying power to motivate patients for long term     rehabilitation programs.)      To overcome the above limitations, this project proposes an evidence-based rehabilitation     model that accounts for actual clinical need and collaborates with our engineering team to     develop a cluster , wearable and Brain-Computer Interface System version of POWER     rehabilitation system. Combining cloud technology, investigators now introduce     internet-of-things into the POWER rehabilitation procedure. The result will lower the burden     of clinical support personnel, and provide an opportunity to quantify frailty syndromes so     as to allow objective and quantitative scientific evaluation, leading to a more objective     clinical diagnosis.      In addition, this project further proposes a virtual-reality (VR) system for POWER     rehabilitation, as well as designs for the VR sceneries. Through the use of different     animated 3D VR sceneries and interactive game design, investigators can make rehabilitation     interesting and fun for the patients, motivating long-term compliance of the patients,     thereby, improving the clinical outcome of POWER rehabilitation.      This project has the potential to create an innovative solution to address the current     bottlenecks of our rehabilitation treatment model. Successful development of the system will     offer rehabilitation clinicians more treatment options, lower the cost of supporting staff,     reduce commuting cost for the patients, and elevate patient desire to comply with the     treatment program. Finally, the system will not only enhance Taiwan's academic reputation in     the international arena, it will also generate new commercial opportunities for Taiwan and     contribute to Taiwan economic development.   "
45824|NCT02685826|"     This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and     regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone     (dex) in subjects with Newly diagnosed multiple myeloma (NDMM).      The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to     determine the optimal regimen.   "
45838|NCT02685644|"     Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for     treatment of endometriosis. However there is evidence that intervention may effect ovarian     reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the     topic are contradictory and employed research methodology are diverse. There is need for an     adequately powered research with proper methodology to assess actual effects of surgery.   "
45839|NCT02685631|"     This research registry studies Yttrium Y 90 resin microspheres in collecting data from     patients with liver cancer not capable of being removed by surgery (unresectable) for the     radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable     (RESIN) liver tumor registry. The information generated will help doctors better understand     treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes     for patients, as well as guide future research for using Y90 therapy, especially for those     conditions where data is currently very limited or lacking.   "
45840|NCT02685618|"     Objective: Safety and efficacy of low-dose prostacyclin administration and blood pressure     target in addition to standard therapy, as compared to standard therapy alone, in     post-cardiac-arrest-syndrome (PCAS) patients.      Trial Rationale: Therapeutic interventions directed towards the damaged endothelium may     improve outcome for patients with PCAS. Prostacyclin/Iloprost (PGI2) is an endogenous     prostanoid which is formed and released by endothelial cells with anti-platelet, vasodilatory     and cytoprotective properties36 and is expected to be beneficial by protecting and     deactivating the endothelium and by restoring vascular integrity in patients suffering from     endothelial breakdown.      Trial Population: Participants in the trial must be adult patients (≥18 years of age) with     out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause admitted to the Dept. of     Cardiology, 2143, Rigshospitalet, Copenhagen.      Trial Design: Randomized, placebo controlled, double-blind investigator-initiated trial in 40     OHCA patients. 48 hours of active study drug (Iloprost, 1 ng/kg/min) versus placebo (saline)     infusion.      Patients in both randomization groups will be treated in accordance with state-of-the art     therapy including targeted temperature management. Interventions are considered emergency     procedures and study drug infusion should be commenced as soon as possible after sustained     return of spontaneous circulation (ROSC), screening and randomization.      Patients will only be enrolled after informed consent, but as the treatment has to be     initiated earliest possible after the out of hospital cardiac arrest diagnosis i.e., at a     time-point where patients are temporarily incompetent, scientific guardians will co-sign the     informed consent form before inclusion. Next-of-kin and the patients' general practitioner     will co-sign as soon as possible and the patient will provide informed consent whenever     possible.      During the study, blood samples will be taken at different time points. Patients will be     observed and assessed continuously with regards to complications including bleeding. Patients     will be actively assessed as long as the patient is in the ICU. During the extended follow up     period at day 30, 90 and 180 contact will be made with the patients to follow up on safety     events and vital status.      The trial is conducted in accordance with the protocol and is approved by Danish health and     medicines authority, Danish ethics committee and danish data protection agency.      Investigational product: The active treatment in the trial is 1 ng/kg/min Ilomedin®     administered as a 48h continuous i.v infusion. The drugs will be administered according to     the product specifications.      Placebo: The placebo is 0.9% saline administered as a 48h continuous i.v infusion. The i.v     volume of placebo saline to be administered is equal to the administered volume of diluted     (in 0.9% saline) active drug.      Sponsor of study and financial support: This research project is investigator-initiated by     the trial Sponsor Pär I. Johansson in collaboration with the principal investigator Christian     Hassager.      It has not received funding from any commercial sponsors.      Patient recruitment period runs from February 2016 to June 2017. Follow-up data on 30-day,     90-day and 180-day outcome and adverse events will be collected. Initial data analyses will     be done after completion of 30-day follow-up for all patients. Secondary data analyses will     be done after completion of 180-day follow-up for all patients.   "
45825|NCT02685813|"     Neural tube defects cover a group of severe embryo malformations such as anencephaly and     spina bifida. The most severe forms of spina bifida causes numerous disabilities that demand     lifelong treatment by a team consisting of primarily neurosurgeons, pediatricians,     obstetricians, pediatric neurologists, pediatric urologists, gastroenterologists,     psychologists and social workers. The disabilities involve morbidity such as decreased motor     and sensory function caudal to the lesion, hydrocephalus, scoliosis, bladder and bowel     incontinence as well as increased mortality.      In 2004, the Danish Health Authorities introduced new guidelines for fetal diagnostics. These     represented a change of paradigm stating that all pregnant women should be offered a prenatal     examination including an ultra sound scan in week 12-13 of gestation (including risk     estimation of chromosomal diseases) as well as in week 19 of gestation (scanning primarily     for malformations). The examination program was not elaborated to eradicate diseases but to     support the reproductive autonomy of the pregnant women, including the possibility to seek     for termination of the pregnancy in the case of severe disease in the fetus.      Severe spina bifida is one of the malformations that can be diagnosed with the ultra sound     scan in week 19, and since the implementation of the new guidelines from the Danish Health     Authority a study by this research group has shown decreased birth incidence at least in the     Western part of Denmark.      It is still unknown what has caused this decrease as is the exact number of pregnancies and     births complicated by spina bifida in the child; similarly it is unclear whether this decline     is a regional or if it is only a Danish phenomenon.      By extraction of data from the Danish Fetal Database (FØTOdatabasen) which includes     information of all 60.000 pregnancies in Denmark annually, the purpose of this register study     is to investigate the incidence of pregnancies complicated by prenatal diagnosis of spina     bifida in Denmark from 2008 and on, as well as the pregnancy outcome in these cases     (including termination of pregnancy). Furthermore results will be compared to results     obtained by collaborative partners in Sweden and hopefully also in Saudi Arabia.   "
45826|NCT02685800|"     Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility problems.     However, despite ART treatment options have evolved over time, the implantation rate remains     rather low.      A possible role for inherited and acquired thrombophilias has been invoked, especially in     women with previous implantation failures. However, several factors could play a role in     these conditions.      A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes,     independently of the presence of thrombophilia, has been recently suggested.      This register is designed in order to better define all possible variables influencing ART     outcome and improve clinical management of women with previous implantation failures. During     this study the investigators will collect and evaluate clinical data regarding the first     cycle in women with previous ART failures.   "
45827|NCT02685787|"     This randomized trial evaluates the efficacy of counselling for reducing anxiety and     depression in caregivers of patients with dementia. Half of the participants will receive six     hours providing counselling and psycho-social support to caregivers along with a specific     telephone support service - Ad Hoc Telephone Counselling whereas the remaining participants     will receive six hours providing general information about Alzheimer Disease.   "
45828|NCT02685774|"     This study is a randomized, open-label, single dose, 2-way crossover study to compare the     pharmacokinetic characteristics of CKD-395 0.25/500 mg in healthy male volunteers.   "
45829|NCT02685761|"     It is the purpose of this study to evaluate the relationship between a low transverse,     vertical midline, and supra-panicular high transverse skin incisions and the rate of wound     complications in women with a BMI of 40 or greater undergoing a cesarean section for     delivery. So far, the choice of incision for the morbidly obese is based only on case     reports. No randomized controlled trials have been done up to date comparing these methods.     It is our hope that a high transverse incision will have all of the benefits of a low     transverse skin incision, with the added benefit of better exposure offered by a vertical     midline incision, without the added increased risk of subjecting the woman to a vertical     hysterotomy.   "
45830|NCT02685748|"     In this double blind randomized clinical trial the investigators are going to exam influence     of adjuvant Aspirin therapy on soft neurological signs (Heidelberg scale), positive and     negative symptoms (PANSS), cytokine profile and inflammatory factors, as well as on cognition     (MoCA) in young psychotic patients.   "
45831|NCT02685735|"     The objective of this research study is to better understand patterns of recovery after Total     Knee Arthroplasty (TKA). The study will evaluate how pain, activity and cognitive (i.e.,     thinking style) responses determine patterns of recovery, and the study will evaluate the     efficacy of gabapentin versus placebo for improving recovery after surgery.   "
45832|NCT02685722|"     This study for a six-month trials, Randomized, open, and parallel comparison before and after     its own, Stage test includes screening stage, treatment period and follow-up period. In     accordance with chronic wound criteria for the patient, By producing the principle of random     number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according     to the situation of wound healing time and decided to use the secondary treatment, To observe     the clinical efficacy and safety.   "
46166|NCT02681354|"     Mild cognitive impairment (MCI) is accompanied by gait and balance problems while dual     tasking. During a 6 to 8 weeks training with the BioRescue (virtual reality),     institutionalized elderly people with MCI will relearn dual tasks in combination with     balance. Afterwards, the transferring effect on gait in general, balance and cognition will     be examined.   "
45834|NCT02685696|"     Objective:      To investigate if the use of the newly designed Alexis O Retractor leads to improved     intra-operative and post-operative surgical outcomes in the setting of planned elective     Caesarean Sections.      Study Design:      This ethically approved study is designed as a prospective, randomized controlled trial in     planned, first time Caesarean Sections with 200 patients randomized to either the Alexis-O     Retractor group or the conventional group. Patients with wound healing problems, connective     tissue disorders, insulin dependent diabetes, bleeding disorders, previous major abdominal     surgery and chorioamnionitis are excluded. Outcomes include surgical site infection,     intraoperative parameters such as tissue damage, postoperative analgesia requirements and     patient satisfaction scores.   "
45836|NCT02685670|"     This is a single-arm open-label phase I/II study to determine the relative superiority of     αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment     potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer     immunotherapy, treatments aiming to arm patients with immunity specifically against cancer     cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs     against B cell malignancies have demonstrated remarkable potential. In this trial, all     subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells     in equal number to test a hypothesis that CD137-costimulation can promote the persistence and     engraftment of CAR-T cells and this superiority can lead to improved progression-free     survival.   "
45837|NCT02685657|"     The purpose of this study is to increase survival of patients with early and locally advanced     triple-negative breast cancer adding selumatinib to standard preoperative chemotherapy     regimen.   "
45842|NCT02685592|"     This study investigates the efficacy of photodynamic therapy (PDT) in the treatment of     lentigo maligna (LM). Hyperspectral imaging system (HIS) will be used to determine the     margins of LM and to rule out possible invasion. Participants will receive photodynamic     therapy three times consecutively with intervals of two weeks using 5-aminolevulinic acid     nanoemulsion (BF-200 ALA, Ameluz®) as a light sensitizing cream. Four weeks after last     photodynamic therapy the lentigo maligna lesion will be excised surgically from the skin.     Result of the treatment is assessed with histopathological examination and     immunohistochemical staining of removed tissue specimen.   "
45843|NCT02685579|"     Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular     nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.   "
45844|NCT02685566|"     The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training     program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly     trained in the reading and interpretation of FFDM and DBT images.   "
45845|NCT02685553|"     The purpose of this study is to determine whether the use of Near-Infrared Technology can     guide the laparoscopic resection of hypervascular neoplasms of the pancreas.   "
45846|NCT02685540|"     Death rate in anesthesia is one of the most valuable methods to assess the safety of     anesthesia practice among different types of patients.      In the investigators study, the investigator will review the death rate in anesthesia whether     regional or general over the past five years from 2010 to 2014, by examining the patients     records from the hospital database.   "
45847|NCT02685527|"     Isolation of contagious patients is expensive, requires more caregiver time, most of the     patients perceive isolation as a mental strain and it has been shown that the level of care     and observation is lower than in a normal ward. But isolation of contagious patients is     necessary to protect other patients, hospital staff and relatives to prevent spreading of     infection and, in worst case out-break.      There are different isolation regimes available depending on causative agent and mode of     transmission. A community-acquired acute gastroenteritis (GE) is most often caused by     Norovirus while a hospital-acquired acute GE is often caused by toxin producing Clostridium     difficile. Patients infected with Norovirus or Clostridium difficile have to be isolated in     single rooms with strict contact precautions. Patients infected with acute GE caused by other     pathogens can be isolated in a multi-bed room if there is a private toilet.      However, at the time of arrival to hospital it is not known if the patient is contagious. The     indication of isolation has to be made based of a clinical evaluation in risk of isolating to     few or too many patients.      Aim of the study:      To identify anamnestic, clinical and paraclinical variables that can be used as indicators of     the aetiology of infectious GE, thus giving an indication for isolation.      To clinically evaluate a combined RNA (Norovirus) and DNA (Clostridium difficile) fast PCR     analysis test to identify infectious GE compared to gold standard methods.   "
45848|NCT02685514|"     To evaluate the short-term efficiency and safety of HIFU treatment in the relapsed Graves'     disease.   "
45849|NCT02685501|"     As combat women soldiers are required to more intensive daily activity the investigators     believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as     characterized by, anemia iron deficiency and reduced quality of life)) on personal     performance will be more significant in combat women soldiers compared to non-combat women     soldiers. Using cohorts from the same environment will enable the investigators to better     study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such     as nutrition. The study does not include any intervention.   "
45850|NCT02685488|"     Depression is the leading cause of disability worldwide. Because a significant number of     people with depression do not respond to medication or therapy, alternative treatment options     are greatly needed. Recent research has focused on brain stimulation methods due to their     therapeutic utility for treating depression. Yet, current brain stimulation methods have     drawbacks, including invasive surgery and limited precision in targeting specific areas. A     novel brain stimulation method, transcranial ultrasound (TUS), is noninvasive, has greater     spatial precision than most existing methods, and is proven safe for humans. TUS has been     found to increase positive mood in chronic pain patients. In a double blind study, TUS     increased positive mood in over 140 healthy undergraduates at the University of Arizona.      Despite evidence that TUS can increase positive mood in humans, it has yet to be investigated     whether TUS can increase positive mood in humans who are experiencing chronic low mood or     depression. The present study will, for the first time, examine whether TUS can improve     depressive symptoms. Twenty to thirty participants with mild to moderate depressive symptoms     (Beck Depression Inventory Score between 10 and 25) will be randomly assigned to a TUS sham     or TUS activation condition. In the TUS activation condition, TUS will be used to stimulate     the right fronto-temporal area, which has previously been shown to increase positive mood.     Participants in the TUS sham condition will not receive any brain stimulation. Participants     will attend five sessions within seven days or ten sessions within fourteen days. At each     session, in addition to brain stimulation, self-reported mood and depressive symptoms will be     recorded. Furthermore, the investigators will use electroencephalogram (EEG) to record     changes in brain electrical signals during TUS stimulation. Based on prior research, the     investigators predict that mood will increase and depressive symptoms will decrease with TUS     stimulation.   "
45851|NCT02685475|"     Background and objectives: The investigators performed this study to explore whether the     presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus     blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary     hypothesis was that the sensory block duration would be delayed in diabetic patients.      Methods: After obtaining ethics committee approval and written informed consent, 71 patients     were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics     were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL     lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and     secondary outcomes were sensory and motor block onset times, motor block duration,     time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores and rescue     analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes were     assessed by a blinded investigators.   "
45852|NCT02685462|"     This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in     Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA     Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine     and Digoxin   "
45853|NCT02685449|"     This is a randomized, cross-over study. The aim of this study is to compare the post-prandial     glycaemic variability after pure protein meal following with an administration of square-wave     bolus of meal-insulin or without any meal-insulin bolus on the other day.      Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of     blood glucose (10-point curve) and CGMS.   "
45855|NCT02685423|"     Amblyopia is an impairment in spatial vision caused by asymmetry in the quality of visual     input across the two eyes during childhood. It is difficult to treat in adulthood because the     visual system becomes less plastic (able to learn) with age. The purpose of this study is     to determine whether five to ten days of visual deprivation--living in complete darkness--can     enhance plasticity in the visual cortex and thereby facilitate the learning that is needed to     recover visual function in amblyopic adults.   "
45856|NCT02685410|"     As part of Yale's Play2Prevent (www.Play2Prevent.org) program to develop videogame-based     interventions targeting risk reduction and prevention in youth and young adults, this study     is designed to develop a paper prototype and intervention design manual of an online     social-network game, One Night Stan, with the goal of risk reduction and HIV/STI prevention     in young black women. The ultimate plan is to incorporate focus group participants input and     feedback into the development of a conceptual model, intervention manual, and videogame     intervention prototype. This prototype will then be tested using 20 participants and will     utilize a pre-post design to evaluate the effectiveness of the program.   "
45857|NCT02685397|"     This adaptive phase II/III randomized trial is designed to demonstrate that eradication of     oligometastases by SBRT is a promising and emerging way to delay disease progression and     postpone second line systemic therapies in castration-resistant prostate cancer (CRPC)     patients. Only CRPC patients with an oligometastatic recurrence will be eligible to take part     in this trial. All participating patients will receive either the standard of care (i.e. LHRH     agonist in combination with the new generation of hormonal therapy [Enzalutamide]) or the     experimental treatment (i.e. LHRH agonist in combination with the new generation of HT     [Enzalutamide] plus the additional SBRT treatment). The patients will undergo different     evaluations before treatment, such as imaging to confirm oligometastatic recurrence and blood     tests. Patients will be stratified according to the location of metastasis (visceral [with or     without bone metastases] vs. bone metastases alone) and PSA doubling time (≤ 3 vs. > 3     months). As per the standard of care, patients will have PSA testing performed every 6-12     weeks and re-imaging at 6, 9, 12, 18 and 24 months or at PSA progression, whichever occurs     first.   "
45858|NCT02685384|"     This innovative and timely study will measure the impact of Affordable Care Act (ACA)     Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health     outcomes. To assess this natural policy experiment, the investigators will use electronic     health record data from the ADVANCE clinical data research network (CDRN) of the National     Patient-Centered Clinical Research Network (PCORnet).   "
46167|NCT02681341|"     The primary objective of this study is to confirm that properties of CardioCel provide     operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine     pericardium not treated with proprietary ADAPT engineering.   "
45860|NCT02685358|"     Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition.     It is associated with compromised health, early mortality, and substantial economic costs.     PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are     not available in the primary care setting. Instead, patients with PTSD are referred to mental     health settings, yet many patients do not accept these referrals or do not adequately engage     in such services. Thus, this project seeks to improve health care for Veterans by testing the     effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In     this treatment a primary care mental health clinician guides patients in using the PTSD Coach     mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with     common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD     symptoms and increasing use of mental health care, it will provide a tremendous benefit to     Veterans with PTSD seen in VA primary care.   "
45861|NCT02685345|"     The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with     placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.   "
45862|NCT02685332|"     Radiation, Stereotactic Body Radiation Therapy.   "
45863|NCT02685319|"     Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging   "
45864|NCT02685306|"     The primary purpose of this research study is to see whether adding bavituximab (an     investigational drug) to the standard chemotherapy drug taxane, will improve the results of     the treatment for early- stage Triple Negative Breast Cancer followed by Standard- of- Care     surgery   "
45865|NCT02685293|"     This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7     days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003     compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7     days) in subjects with moderate to severe COPD.   "
45866|NCT02685280|"     From 1999 onwards, Deep Brain Stimulation [DBS] has been proposed as an alternative to     capsulotomy in refractory cases of Obsessive-Compulsive Disorder [OCD]. More recently,     several studies with DBS in patients with major depression have been initiated. In Belgium,     there is currently a reimbursement for devices for DBS for OCD, but not for rechargeable     neurostimulators, in these OCD patients.      Although rechargeable neurostimulators are widely used in spinal cord stimulation for pain     and DBS for movement disorders, they have not yet been used in DBS for psychiatric disorders     population. Several possible problems might arise with the use of rechargeable     neurostimulators in this highly specific population.      In this prospective study with a before-after design, we would like to determine if the use     of rechargeable neurostimulators is effective, applicable and safe and capable of diminishing     the need for neurostimulator replacement procedures.   "
45867|NCT02685267|"     This is a prospective randomized phase II clinical trial where patients who are receiving     enzalutamide in the pre-chemotherapy space are randomized upon objective progression     (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same     combination plus enzalutamide.      The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel     in patients who failed or progressed while on enzalutamide would increase progression-free     survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients     alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL)     using validated scales.   "
47535|NCT02663414|"     The objective of this study is to collect post market data on safety and performance of the     Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through     a 24 months post-operative follow-up period.   "
45868|NCT02685254|"     This study aims to examine if structured skills training group therapy for ADHD in adults has     beneficial effects superior to 'treatment as usual' including medication in a controlled     outpatient setting on clinically relevant outcomes including symptoms, functioning and     quality of life measures.      The trial is designed as a multicenter randomized controlled, parallel group study. Patients     are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial     intervention by structured skills training groups by weekly sessions or one with control     condition (treatment as usual). Then after 15 weeks patients in the control condition arm are     switched to the active intervention by 14 weeks of structured group therapy. All patients are     assessed for defined outcomes after six months.   "
45869|NCT02685241|"     Breath analysis is a non-invasive procedure to detect and monitor diseases and it is     particularly attractive for patients who have to routinely check biomarkers, such as     diabetics (blood glucose) or end-stage renal disease patients (creatinine). Preliminary data     in a small study with healthy subjects showed a high correlation between blood glucose levels     and acetone. Therefore, the objective of this study is to correlate biomarkers (glucose level     and creatinine, respectively) with the corresponding target breath components (acetone and     NH3, respectively) detected by portable gas sensors in the general population and to assess     possible predictive models for biomarker estimations from the corresponding target breath     component and predictive models to estimate abnormal biomarker concentrations.   "
45870|NCT02685228|"     The purpose of this study is to investigate the effect of very low dose decitabine combinate     with gemcitabine in the first-line treatment of locally advanced, unresectable and metastatic     pancreatic cancer.   "
45871|NCT02685215|"     Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary     failure and cardiomyopathy affect prognosis.The investigators aim to establish predictive     factors for mortality and morbidity in Intensive care unit (ICU ) and to describe the long     term follow up after ICU discharge.   "
45872|NCT02685202|"     The purpose of this study is to characterize the course of temporomandibular disorder (TMD)     pain in adults with TMD and obstructive sleep apnea (OSA), all of whom are being treated with     mandibular advancement splint (MAS) therapy.      Study participants are 12 adults with painful TMD and comorbid mild to moderate OSA     (apnea-hypopnea index ≥5 and <30).      This is an interventional study in which 12 patients receive MAS therapy for comorbid TMD/OSA     for 16 weeks. It is standard of care to treat mild or moderate OSA with MAS therapy, the the     effect on MAS therapy on TMD pain in people with OSA is unknown. There is no comparison     group. Care is being provided under the direction of a sleep physician by a dentist who     specializes in dental sleep medicine. The investigators expect that as MAS therapy reduces     the severity of OSA, painful TMD symptoms will also reduce.   "
45873|NCT02685189|"     The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data     from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) An     Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For     Exchange Transfusion.   "
45874|NCT02685176|"     This Clinical trial is being conducted to study the effectiveness of heat donation through     head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia.     The purpose of the study is to compare the core rewarming effectiveness of the same amount of     heat donation through the head or torso in treatment of hypothermia using a human model for     severe hypothermia. The information obtained from this study will give a better understanding     of heat-transfer mechanisms. This might help in the ongoing research in hypothermia     treatment.   "
45875|NCT02685163|"     Formation of reactive oxygen species (ROS) contributes to pathogenesis and progression of     several diseases. Polyphenols, have been shown to be beneficial against ROS.      This study evaluate the effects of a natural antioxidant ice-cream,rich in polyphenols, on     oxidative stress, vascular function and physical performance. In this controlled,     single-blind cross-over study, 14 healthy subjects were randomized to assume 100 mg of     antioxidant ice-cream consisting of dark cocoa powder, extract of hazelnut and green tea, or     milk chocolate ice-cream (control ice-cream). Subjects were studied at baseline and two hours     after the ingestion of the ice-creams. Serum polyphenols, antioxidant status (ferric reducing     ability of plasma, FRAP), NO bioavailability (NOx), markers of oxidative stress (D-Roms and     H2O2), endothelium function (FMD and RHI) and exercise tolerance (Stress Test) with     measurement of the double product were assessed.   "
45876|NCT02685150|"     Endoscopic Tri-Modal Imaging which combines Narrow-band Imaging(NBI), Autofluorescence     Imaging (AFI) and White-light Imaging (WLI) could be used to identify the indistinct changes     in the gut caused by reflux disease,either acid reflux or bile reflux, which make it possible     to differentiate reflux disease from functional dyspepsia (FD).   "
45877|NCT02685137|"     This is a randomized, sham-controlled (placebo) trial of a single intramuscular injection of     Stannsoporfin compared to sham (placebo) in healthy term and near-term newborns admitted to     the well-baby nursery and enrolled with intention to treat.   "
45878|NCT02685124|"     This study evaluates the effect of intake of two orange juice varieties in healthy adults.     The participants will receive Bahia orange juice, Cara-Cara orange juice or a isocaloric     control drink in a cross-over study.   "
45879|NCT02685111|"     To compare the efficacy and safety of Day 2 (D2) once a cycle pegfilgrastim with Intermittent     Every Other Days of 5 Shot (D3-11) filgrastim in early breast cancer patients treated with     adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) regimen   "
45880|NCT02685098|"     Patients undergoing semi-elective below knee amputation from complications associated with     atherosclerotic limb ischemia will received intra-muscular injections of allogeneic     Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent     ischemic wound complications after surgery and decrease the incidence of conversion from     below knee to above knee amputation.   "
45881|NCT02685085|"     Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical     foley's cather administration and both techniques performed together.   "
45920|NCT02684578|"     The purpose of this study is to determine whether metformin, an FDA-approved drug for the     treatment of type II diabetes, is a safe and effective treatment to decrease the progression     of geographic atrophy in non-diabetic patients with Age-related Macular Degeneration (AMD).   "
45882|NCT02685072|"     This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of     50 women who smoke and have regular menstrual cycles will be randomized to either     progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks.     TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at     the end of Week 8. All participants will also be provided behavioral treatment for smoking     cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week     period (Week 1) during the mid luteal phase, within a week before menses and the target quit     date will be set for the 5 (+/-2) days after onset of menses. Participants will have     post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of     smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving     and nicotine withdrawal, and measures of response inhibition.   "
45883|NCT02685059|"     To date no targeted agents are available to treat TNBC. Therefore chemotherapy is the only     treatment option. TNBC often has a high amount of tumour infiltrating lymphocytes.     Stimulating the immune cells of TNBC might therefore be an option for these patients to     increase the pathological complete response. pCR is highly correlated with outcome in TNBC.      Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an     additional option for these patients.   "
45884|NCT02685046|"     In this proof-of-concept trial the investigators will study the effects of imatinib treatment     on the biology of mesenchymal-type colon cancers.   "
45885|NCT02685033|"     This clinical study will be a single-center, randomized, open-label, active-controlled,     parallel-group study comparing dalbavancin to standard of care (SOC) therapy in     osteomyelitis.   "
45886|NCT02685020|"     The primary purpose of this study is to assess safety, tolerability of the different vaccine     schedules (different regimen durations and different number of dose administrations) with     Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody     (Ab) responses of the different vaccine schedules.   "
45887|NCT02685007|"     The purpose of this study is to describe ease of use and satisfaction with application of the     pre-rolled TachoSil in laparoscopic procedures within approved therapeutic indication as per     Summary of Product Characteristics (SmPC).   "
45888|NCT02684994|"     This study will take place over approximately 6 months and includes 3 assessment appointments     (where information will be gathered, but no direct treatment provided) and 12 treatment     sessions of cognitive processing therapy if eligible.   "
45889|NCT02684981|"     The aim of this non-interventional study is to describe patient's perception of anticoagulant     treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from     atrial fibrillation (according to its approved indication in the approved dosages of 110     milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K     Antagonist (VKA).   "
45898|NCT02684864|"     Adults with degenerative meniscal tear receiving arthroscopic surgical management or knee     drainage (arthrocentesis) +/- intra-articular steroid injection will be recruited to this     non-interventional cohort study. The aim is to investigate whether measurement of an     individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms     predicts symptomatic and functional outcome suggestive of osteoarthritis (OA) of the knee.   "
45890|NCT02684968|"     Eligible patients will be randomized 1:1 without stratification to bilateral continuous QL     catheters with local anesthetic continuous infusion (QL block + IV patient-controlled     analgesia group) or normal saline continuous infusion (IV patient-controlled analgesia     group).      In the postanesthesia care unit (PACU), patients will be given intravenous boluses of     hydromorphone or fentanyl as needed. Following immediate recovery from anesthesia, patients     will be provided with a hydromorphone IV patient-controlled analgesia pump with standard     initial settings and an option of clinician dose for breakthrough pain. IV patient-controlled     hydromorphone pump settings will be titrated to comfort level (pain score<4) by blinded     clinicians.      Each of the catheters will be connected to patient controlled infusion pump running at a     basal rate of 6mL/hour of 0.1% Bupivacaine or normal saline with on-demand bolus of 5 mL     every 60 minutes to be started in the operating room before the surgical incision.      Opioid consumption first 72 hours or until discharge, whichever comes first will be recorded.      Pain scores during first 72 hours or until discharge, whichever comes first will be recorded     with a verbal rating scale and obtained from the patient's electronic medical records.      The morning of post operative day 1 and post operative day 3 the ORSDS and QOR surveys will     be completed.      Morning of the day of discharge, the overall patient satisfaction with pain management survey     will be completed.   "
45891|NCT02684955|"     Cardiac arrest remains a leading cause of death, currently affecting >250,000 Europeans     outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between     15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest,     the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with     trained resuscitation teams. However, only 5-10% of patients will survive with good     neurological status. A good quality CPR, a short time before initiation of the resuscitation     and a short delay before the first defibrillation have been associated with improved     neurological outcome. Unfortunately it is currently impossible to obtain reliable information     on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring     during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2     (EtCO2). The last one is the only parameter which have been linked with probability of ROSC     and its value gives no indication of the long-term prognosis nor the neurological status.      Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a     noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting     the balance between need and supply of brain oxygenation. This technique has been recently     used in cardiac arrest showing a possible association between rSO2 measured during CPR and     the occurrence of ROSC or survival. The quantitative measurement of the pupillary light     reaction has been described to predict neurological outcome in the hospital for patient     successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility     study has shown that its use was also possible during CPR in the pre-hospital setting.      The investigators aim to study a composite prognostic factor combining quantitative rSO2 and     automated pupillometry measured during CPR. The investigators hypothesized that the rate of     survival with good neurologic outcome at 30 days will be lower in patients with rSO2 <30% for     more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .   "
45892|NCT02684942|"     Purpose: To compare the pain level and quality of life of the two sedation regimens     consisting of diazepam in combination with meperidine or fentanyl.      Materials and methods: A total of 40 patients (160 sessions of brachytherapy), unselected     brachytherapy out patients at Chulabhorn Hospital, Thailand were enrolled with informed     consent and randomized to receive meperidine or fentanyl. Data of perceived pain (according     to standard 10-cm visual analog scales [VAS]), and perceived Quality of life (EQ-5D) were     collected. Patients and all brachytherapy staffs directly involved with the procedure were     blinded about the drug used.   "
45893|NCT02684929|"     Branched-chain amino acids (BCAA) belong among nutrients strongly linked with insulin     sensitivity (IS) measures. Their exact effect on IS appears to be dependent on various     conditions that remain to be better defined . The aim of the current study was to investigate     effects of chronic increase of BCAA intake on IS in two groups of healthy subjects differing     in their basal consumption of BCAA, i.e. vegans and omnivores. Interventional trial was     designed where vegans and omnivores were separately interveined with 15 (women) or 20 (men)     grams of BCAA daily. Examinations of participants are intended to be done at baseline, after     the intervention and wash-out period. Examinations (anthropometry,     hyperinsulinaemic-euglycaemic clamp, arginine test) and blood analyses will be performed at     baseline, after the intervention and after a 6 month wash-out period. Samples of subcutaneous     abdominal adipose tissue (AT) and skeletal muscle (SM, vastus lateralis) obtained before and     after the intervention will be used for various analyses (mRNA levels of selected metabolic     markers, fatty acid composition, mitochondrial activity).   "
45894|NCT02684916|"     The primary aim of the study is to assess the effectiveness of chiropractic manipulation     treatment versus placebo treatment in children suffering from headache for more than six     months.   "
45895|NCT02684903|"     This is a randomized, controlled trial of Parent-Child Interaction Therapy (PCIT) designed to     test the effects of PCIT on self-regulation and behavior in child maltreating (CM) parents     and their elementary-school children. Two hundred-fifty (250) maltreating mothers and their     children (age 5-8 years) will be drawn from Child Protective Services and randomized to the     PCIT intervention or a control condition (services as usual). Key contextual risk factors     will be assessed, including cumulative risk, parent mental health, and parent substance use.     A multirater, multimethod approach to assessment will include neural (EEG/ERP), physiological     (ECG), behavioral, and self-report measures of self-regulation in CM mothers and their     children, as well as standard measures of parenting skills and children's behavior outcomes.     Families will be followed at 6 months for self-regulation, parenting, and child behavioral     outcomes, and to 1 year for CM recidivism. Findings from this proposed study are expected to     have significant implications for optimizing CM parenting interventions by (a) determining     the sensitivity of CM parent and child neurobehavioral self-regulation systems to     intervention, and (b) identifying individual differences in self-regulation that mediate and     moderate response to intervention and long-term maintenance of gains.   "
45896|NCT02684890|"     Tinnitus may affect the ability of patients to detect emotions in spoken language. This study     will compare this ability between tinnitus patients and non-tinnitus patients.   "
45897|NCT02684877|"     The investigators contacted consecutive adult patients admitted to intensive care unit (ICU)     and mechanically ventilated for at least 72 hours to invite them to an interview at hospital.     The investigators administered Mini Mental Status Examination, Functional Assessment of     Chronic Illness Therapy scale for Fatigue (Facit- F) and Short form 36 questionnaires to the     consenting patients.   "
45912|NCT02684682|"     The purpose of this blind randomized clinical trial is to evaluate different frequencies in     self-mechanical control of plaque in individuals with historic of periodontitis and in     periodic and preventive maintenance in order to assess which frequencies are compatible with     maintaining gingival health.   "
45899|NCT02684851|"     The purpose of this study is to determine if patients undergoing acetabular ORIF (open     reduction with internal fixation) who receive tranexamic acid have a reduced risk of     allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for     thromboembolic events compared to patients who receive placebo. Investigators want to     determine the cost-effectiveness related to allogenic blood transfusion as a blood loss     management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic     surgery carries with it a significant risk for blood loss. Current management of     perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood     transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse     reactions. There have been significant efforts to reduce the use of allogenic blood     transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been     used in management of blood during surgery. In order to determine the impact of tranexamic     acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will     conduct a prospective randomized study. Patients undergoing acetabular surgery will be     screened for this study. Patients will be then randomized to placebo or tranexamic acid which     will be administered during and after surgery. The following data will be collected: patient     characteristics, surgery information, blood loss, blood transfusions, wound complication     within 30 days of surgery, and cost.   "
45900|NCT02684838|"     This is a prospective, observational registry in patients who have been prescribed Gliadel     Wafer by the physician as part of usual care.   "
45901|NCT02684825|"     The primary objective of this study is to evaluate whether, in patients with first-ever     atherothrombotic or lacunar stroke without any previous history of atrial fibrillation     (AF)/atrial flutter (AFL)/atrial tachycardia (AT), the detection of AF/AFL/AT (silent or     symptomatic) by using a continuous cardiac rhythm monitoring with implantable loop recorder     (ILR) during the first 12 months of observation is higher than the detection by using a     standard cardiac monitoring (physical exam, 12-lead electrocardiogram [ECG] at baseline, 3,     6, and 12 months and Holter ECG at 3 months) in the same period of time.   "
45902|NCT02684812|"     This is a multicenter, prospective, randomized, open-label trial with blinded endpoint     (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by     computed tomography (CT) within 24 hours after the onset of headache, will be randomly     assigned to the treatment group or the control group. Patients in the treatment group will     receive standard treatment with the addition of a bolus of TXA (1 g intravenously)     immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the     start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients     in the control group will receive standard treatment without TXA. The primary outcome measure     is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale     (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for     treatment allocation.   "
45903|NCT02684799|"     This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess     the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC   "
45904|NCT02684786|"     Pulmonary hypertension Group 2 (PH 2) associated with left-sided heart disease is relatively     common, is associated with a poor prognosis, and unfortunately there are no proven medical     treatments beyond attempts at correcting the left sided heart disease. Many PH 2 patients     have evidence of active constriction of blood vessels from increased nerve traffic. Use of     agents or procedures which produce a reversible chemical blockage of this nerve traffic have     not been systematically tested in PH 2. The investigators will test whether acute     interruption of sympathetic nervous system tone, which local anesthetic block of the stellate     ganglion in the neck, will improve PH2, and also test whether the high blood pressure drug     reserpine, which blocks sympathetic nerve activity, will do so during a one month trial     period.   "
45905|NCT02684773|"     Background: In 2010, approximately 39000 Canadians had end-stage renal disease (ESRD), and     the prevalence rate of dialysis has increased by 189% over the past 2 decades. The annual     mortality rate remains high at ~15%, and cardiovascular events are the leading cause of     death. Intensification of conventional dialysis schedules has been the major focus in recent     years. Currently, most Canadian dialysis patients receive conventional in-center hemodialysis     (CHD), which is administered as a 3-4 hour session 3/week. Recent research has focused on     home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights/week), which may     have substantial cardiovascular benefits, including regression of left ventricular (LV)     hypertrophy, improved LV ejection fraction and enhanced blood pressure control. Nevertheless,     this dialysis modality is only feasible in a highly selected minority of ESRD patients who     can self-manage their dialysis treatment at home. In-center nocturnal hemodialysis (INHD),     administered as 7-8 hours of hemodialysis in hospital for 3nights/week, represents a     promising and practical alternative for many dialysis patients. In a Canadian Institutes for     Health Research (CIHR) supported cohort study, the investigators have recruited 67 patients     and have completed 1-year follow-up. There is a compelling need for longer-term follow-up,     since all the published randomized controlled trials are of short duration (6-12 months),     while renal replacement therapy is a life-long treatment. Furthermore, the observed large     variability of cardiac remodeling in individual ESRD patients remains poorly understood.     Therefore, the current study is an extended follow-up phase (5 years from enrollment) on the     completed 1-year follow-up period and the purpose of this study is to objectively evaluate     the long-term effects of more intensified hemodialysis treatment which the INHD modality     offers.      Need for Long-term and Generalizable Data: In contrast to the seminal Alberta trial which     showed a significant LV mass reduction with home nocturnal hemodialysis, the recently     reported Frequent Hemodialysis Network Nocturnal Trial demonstrated only a trend toward     reduction in LV mass. It is likely that the highly selected participants, inadequate trial     power and duration (12 months) account for the observed results. Currently, it is unknown     whether INHD, which is less intensive but more feasible for most ESRD patients, is associated     with similar cardiovascular benefits in the long term.      Objective:        1. To determine the long-term effects of INHD on (i) LV mass; (ii) global and regional LV          systolic and diastolic function; (iii) myocardial tissue characteristics; (iv) left          atrial structure and function; (v) selected cardiovascular biomarkers in ESRD patients.        2. To examine the determinants and mechanisms of cardiac remodeling in ESRD      Hypothesis: Conversion to INHD is associated with sustained improvements in cardiovascular     structure and function, as compared to conventional hemodialysis (CHD) in patients with     end-stage renal disease (ESRD).      Study Design and Population: This will be a 2-centre, prospective, longitudinal cohort study     of 67 adult ESRD patients (INHD subjects and CHD controls) enrolled in the original study.     All eligible participants who provide consent will undergo cardiac Magnetic Resonance Imaging     (MRI) examination and bloodwork at 5 years since enrollment in the study. Other follow-up     procedures include the following -electrocardiogram, transthoracic echocardiogram, ambulatory     blood pressure monitoring, lateral x-ray of the aorta, and completion of questionnaires.      Outcome: The primary endpoint is the change in LV mass over 5 years, as measured by cardiac     MRI. Secondary endpoints include LV size, global and regional diastolic and systolic     function, left atrial size and function, changes in myocardial tissue characteristics, blood     pressure, serum troponin, norepinephrine, Brain Natriuretic Peptide (BNP), high sensitivity     C-Reactive Protein (hsCRP), interleukin-6, matrix metalloproteinases, fibroblast growth     factor-23, fetuin-A, transforming growth factor-beta, connective tissue growth factor,     clinical events, and quality of life.      Significance: The provision of an enhanced dialysis regimen has emerged as the most promising     avenue through which to modify the dismal cardiovascular outcomes in patients receiving     chronic hemodialysis. INHD represents a means of administering such therapy to a broad     spectrum of dialysis patients for whom home therapies would not be feasible. This study will     be the first to precisely define the long-term cardiac effects of intensified dialysis and to     elucidate the mechanisms of cardiac remodeling in ESRD, using cardiac MRI and other novel     biomarkers. These important observational findings may have a major impact on the optimal     management and outcome of ESRD patients in the real world.   "
45906|NCT02684760|"     PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will     test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral     solution formulation under fasting conditions and the effect of a high fat meal on the     bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and     tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed     under fasting and fed conditions.   "
45907|NCT02684747|"     A total of 40 subjects will be recruited for participation in this study. 20 subjects (10     males and 10 females) will be randomized to the active group (those receiving re-infusion of     autologous blood) and 20 subjects (10 males and 10 females) will be randomized to the placebo     group (receiving NS infusion).   "
45908|NCT02684734|"     Colitis from reactivation of established cytomegalovirus (CMV) colonization can complicate     the clinical course in patients with an acute flare of ulcerative colitis (UC). Accurate and     timely detection of active CMV infection or disease with appropriate anti-viral therapy may     reduce complications associated with acute UC flare. Limited information is available on the     presence of colonic CMV infection in patients with quiescent ulcerative colitis. Prospective     studies on factors associated with reactivation of CMV infection during active UC flare and     its impact on disease progression are lacking.      The hypothesis of this study are as follows: 1) CMV infection is prevalent in patients with     ulcerative colitis irrespective of disease severity; 2) The degree of immunosuppression     directly impacts CMV infection status in patients with ulcerative colitis   "
45909|NCT02684721|"     In a randomised design the study aims to investigate whether an intervention of 8 weeks     home-based exercise in addition to usual care can positively influence the physical capacity,     quality of life, sick leave and use of psychoactive drugs in patients medically treated for     pulmonary embolism.   "
45910|NCT02684708|"     The EuroNet-PHL-C2 trial is an international, multicentre, randomised controlled trial with     the aims to reduce the indication for radiotherapy in newly diagnosed patients with classical     Hodgkin lymphoma without compromising cure rates and to investigate a chemotherapy     intensification randomisation in intermediate and advanced classical Hodgkin lymphoma to     compensate for reduction in radiotherapy.   "
45911|NCT02684695|"     This observational study aims to develop and validate quantitative magnetic resonance imaging     biomarkers as measures of disease activity in juvenile idiopathic arthritis (JIA). This     includes patients with enthesitis-related arthritis (ERA).   "
45913|NCT02684669|"     In several rodent studies, it has been demonstrated that very high doses of opioid     antagonists (i.e., naloxone 3-10 mg/kg) administered after weeks after recovery from an     inflammatory injury may lead to a reinstatement of hyperalgesia and pain behavior. This     latent sensitization has recently been demonstrated also to take place in humans.      The present study examines if it is possible to foresee individuals who will demonstrate a     larger degree of latent sensitization upon challenge with an injury, than others. Using an     enriched design high sensitizers (e.g., the upper quartile of individuals developing large     areas of secondary hyperalgesia following a mild burn injury) are compared with low     sensitizers (lower quartile), regarding the propensity for developing latent sensitization   "
45914|NCT02684656|"     The health care burden of CKD is substantial and growing with 10-15% of the population     affected in both developed and developing countries. It is well established that CKD is     associated with systemic inflammation, which promotes cardiovascular disease and body     wasting. However, causal therapies to treat systemic inflammation, and treat its adverse     consequences remain sparse. As kidney function declines in all forms of CKD, oxalate levels     increase in the plasma, leading to increased systemic exposure to oxalate and consequent     tissue injury. Work from the investigators has shown that elevated plasma oxalate levels     activate the NLRP3 inflammasome which in turn leads to the processing and release of     cytokines. The investigators seek to test the hypothesis that oxalate contributes to the     systemic inflammation observed in patients with end-stage renal disease (ESRD). The     investigators plan to define the association between plasma oxalate levels and signs of     systemic inflammation in patients on hemodialysis. In a second step the investigators will     examine whether hemodiafiltration lowers plasma oxalate more efficiently than hemodialysis     and reduces signs of systemic inflammation. Confirmation of the hypothesis may lead to the     identification of oxalate as a novel therapeutic target for interventional trials aimed at     reducing plasma oxalate in patients with ESRD.   "
45915|NCT02684643|"     This study is designed to study and compare the efficacy and cost-effectiveness of     individualized phosphate-lowering therapy in comparison with regular guideline-recommended     therapy.   "
45916|NCT02684630|"     The purpose of this study is to optimize collected platelet yields in single and double     platelet collections, while maintaining donor postplatelet count of >100,000/µL.   "
45918|NCT02684604|"     Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing     that with it's prevalence in fertile women.   "
45919|NCT02684591|"     A subset of patients with NAFLD that have not been extensively studied are those infected     with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for     NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients     with NAFLD and there are no approved treatment options. We plan to conduct a randomized,     double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of     Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given     over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and     accurate magnetic resonance imaging (MRI)-based technique.   "
45921|NCT02684565|"     Branching chain amino acids (BCAA) have both beneficial and detrimental effects of on     metabolism have been established and therefore warrants further investigation. In the     preliminary study, the investigators found that BCAAs enhanced glucose metabolism in lean     mice while they promoted glucose intolerance in obese mice. In lean mice, BCAAs decreased     adiposity and enhanced glucose utilization and insulin sensitivity in different tissues. But     in obese mice, BCAAs' effects were mediated by impaired insulin signaling in fat tissue.      This study will examine 10 obese subjects with pre-diabetes and examine the effects of taking     BCAA supplement and will monitor the subjects blood glucose, insulin, triglyceride levels and     will have an oral glucose tolerance test on repeated occasions to see if any changes are     noted in their glucose regulation.   "
45922|NCT02684552|"     Patients with cystic fibrosis older than 18 years will performance a Bruce test with non     invasive ventilation (once) after 30 minutes they perform the same test with oxygen     supplementation.      Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.   "
45923|NCT02684539|"     syncope prediction on tilt table   "
45924|NCT02684526|"     To examine the quality of liver images produced when the contrast agent Eovist is used during     MRI.   "
45978|NCT02683811|"     This study evaluates the short- and long-term effects on psychological wellbeing and     health-related behaviours of the updated version of a universal school-based program called     Diario della Salute (DDS-2) in Italian students aged 11-13 years.   "
45979|NCT02683798|"     A study to determine the effectiveness of two weight loss maintenance interventions in     Counterweight Plus, a structured weight management programme.   "
45925|NCT02684513|"     For more than 15 years, traditional fasting regimens prior to scheduled surgeries have been     called into question, yet prolonged preoperative fasting remains common practice. While     prolonged fasting is aimed at reducing the risk of pulmonary aspiration, prolonged fasting is     uncomfortable, has an inconsistent effect on gastric volumes and acidity and may lead to     dehydration without a clear reduction in the incidence of aspiration. Fasting by itself     decreases hepatic glycogen stores, induces a state of insulin resistance and impairs     cardiovascular function. Yet, prolonged preoperative fasting remains common.      Preoperative oral carbohydrate (CHO) consumption improves insulin sensitivity and decreases     the time to return of gut function without increasing gastric volumes or acidity compared to     other clear liquids and fasting. Previous work has shown oral CHO consumption improves     patient well-being to a greater degree than placebo drink (water or flavored water) and     fasted controls. Oral CHO also outperforms a similar volume of intravenous glucose     supplementation. These benefits have reduced hospital stays in a variety of surgical models     by as much as 20%. Further, preoperative CHO supplementation improved postoperative patient     hunger, thirst, anxiety, fatigue and nausea.      The purpose of this research study is to determine if drinking a high carbohydrate beverage     before cesarean section surgery can improve patient well-being, compared to patients who     drink a low carbohydrate beverage or fast before surgery.   "
45926|NCT02684500|"     The purpose of this research study is to determine if the diameter and flow of the superior     mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive     therapy for cerebral artery vasospasm are effected enough to justify withholding enteral     nutrition.   "
45927|NCT02684487|"     Sepsis is a clinical entity that complicates infection. Without early recognition and timely     management, it can rapidly progress to severe sepsis, septic shock, and culminate in multiple     organ dysfunction syndrome. Forty to 70% of septic patients have low vitamin D status, yet     little is known about the impact of vitamin D3 (vitD3) supplementation in this patient     population. As such, the investigators propose a randomized, double-blinded,     placebo-controlled trial to test the hypothesis that early, rapid correction of low vitamin D     status, as an adjunct to established treatment guidelines, will improve clinical outcomes and     measurably alter immune profile in patients with severe sepsis.   "
45928|NCT02684474|"     The purpose of this protocol is to provide treatment with HBOC-201 to patients with     life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201     [hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative to blood     transfusions in severely anemic patients needing a way to enhance tissue oxygenation.     HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified     lactated Ringer's solution, and does not require blood compatibility.   "
45929|NCT02684461|"     The purpose of this research study is to test the effectiveness of three treatment arms that     are designed to improve survival in patients with non-small cell lung cancer. Eligible     subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or     immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.   "
45930|NCT02684448|"     This multi-center, retrospective data collection study will evaluate the feasibility, safety     and performance of the da Vinci® surgical system for patients who have undergone     robotic-assisted inguinal hernia repair, as well as provide information about the learning     curve associated with robotic-assisted (da Vinci®) inguinal hernia repair.      In addition, this retrospective data collection study will evaluate the perioperative     outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative     outcomes with those associated with open hernia repair by the same participating surgeon.   "
45931|NCT02684435|"     The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney     malignancies   "
45932|NCT02684422|"     This study aims to examine features of MRSA that are associated with chronic MRSA infection     and bacterial persistence despite IV antibiotic therapy. Subjects are asked to expectorate     sputum and complete CF symptom diaries both at beginning and end of IV therapy.   "
45933|NCT02684409|"     This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy     adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity     patch application. Subjects will be admitted 2 hours prior to dosing on Day 1, and will     remain in the clinical unit under supervision until the last pharmacokinetic (PK) sample is     obtained. Blood will be obtained at prescribed times for PK analysis and safety assessments     will be performed, including adverse event monitoring, 12-lead ECG test, patch adhesion     evaluations, skin irritation evaluations, and vital signs.   "
45935|NCT02684383|"     Infection with dengue viruses is the leading cause of hospitalization and death in children     in many tropical Asian countries, and the development of a dengue vaccine is a top health     priority. This study will evaluate the safety and immunogenicity of a live attenuated     monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous     flavivirus infection.   "
45936|NCT02684370|"     This is a randomized double blind, double dummy, placebo and active comparator controlled,     parallel design study that is being performed to assess the safety and efficacy of BI     655066/ABBV-066 (risankizumab) to support registration for the treatment of moderate to     severe chronic plaque psoriasis in adult patients.   "
45937|NCT02684357|"     This is a randomized double blind, double dummy, placebo and active comparator controlled,     parallel design study that is being performed to assess the safety and efficacy of BI 655066     to support registration for the treatment of moderate to severe chronic plaque psoriasis in     adult patients.   "
45938|NCT02684344|"     This randomized open-label study will be comprised of 2 cohorts: one control group and one     treatment group. The trial will be conducted as an open label randomized trial to evaluate     the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study     will include pre- and post-surgical evaluations of patients including symptoms of urinary     retention and any adverse effects contributable to the study medication.   "
45939|NCT02684331|"     The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM),     with or without known cardiovascular disease, will be recruited from the diabetes outpatient     clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic     resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.      This study project sets out to answer the following hypotheses:        1. Patients with T2DM have an increased risk of developing diastolic dysfunction. Using          CMR, the investigators wish to measure left ventricle peak filling rate and passive          atrial emptying fraction as a measure of cardiac diastolic function. The investigators          hypothesize that classic T2DM markers such as levels of urinary albumin excretion,          retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM          duration, etc. are associated with pathological findings by CMR.        2. Patients with T2DM have impaired left ventricle myocardial perfusion as determined by          gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk          factors mentioned above, are associated with left ventricle myocardial hypoperfusion as          determined by gadolinium contrast CMR.   "
45940|NCT02684318|"     Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with     olaparib in patients with advanced solid tumors.   "
45941|NCT02684305|"     Induction of labor is one of the most common obstetrical medical procedures performed today.     Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is     undertaken for various maternal and fetal indications and spans 20% of deliveries today.        1. During the past years there has been an additional rise due to elective inductions        2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks          of induced delivery, particularly those associated with post-term pregnancy, rupture of          membranes, oligohydramnios and additional fetal and maternal conditions that pose risks          to mother and fetus.      In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less)     sequential induction with more than one agent is necessary. To date, no trial has compared     the optimal subsequent ripening method after the preliminary use of dinoprostone     (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of     subsequent induction in women admitted for induction of labor with Bishop score <7 or less 24     hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine     induction of labor will be compared: An additional Propess induction for another 24 hours vs.     intravenous oxytocin infusion combined with intra-cervical balloon insertion.   "
45942|NCT02684292|"     The purpose of this study is to evaluate pembrolizumab (MK-3475) in the treatment of     participants with relapsed or refractory Classical Hodgkin Lymphoma. Participants will be     randomized to receive either pembrolizumab or brentuximab vedotin for up to 35 three-week     cycles of treatment.      The primary hypotheses of this study are that treatment with pembrolizumab prolongs     Progression Free Survival (PFS) and Overall Survival (OS) in participants with relapsed or     refractory Classical Hodgkin Lymphoma compared to treatment with brentuximab vedotin.   "
45943|NCT02684279|"     Binge Eating Disorder Extension Study.   "
45944|NCT02684266|"     SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this     study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in     Chinese advanced solid tumor patients by using a 3+3 dose escalation.Preliminary efficacy     will be also investigated in this study.   "
45945|NCT02684253|"     Nivolumab is an antibody (a type of human protein) that is designed to boost your body's     immune system. It does this by allowing immune cells to grow and fight the cancer. Nivolumab     has been approved by the FDA for the treatment of melanoma (a form of skin cancer) and lung     cancer. It is currently under study for the treatment of head and neck squamous cell cancer.   "
45946|NCT02684240|"     This research is being done to determine if Nitazoxanide (NTZ) will cause a significant     decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The     study is being conducted at the GHESKIO Centers in Port au Prince Haiti   "
45947|NCT02684227|"     This clinical research study has two parts: a safety lead-in and Phase 2.      The goal of the safety lead-in is to find the highest tolerable dose of enzalutamide in     combination with carboplatin and paclitaxel that can be given to patients with recurrent or     advanced endometrial cancer.      The goal of Phase 2 of this study is to learn if the study drug combination can help to     control recurrent or advanced endometrial cancer.      The safety of the drug combination will be studied in both parts of the study.   "
45948|NCT02684214|"     The ability of Prevention Plus to improve weight status when delivered by primary care     providers is unknown, and the influence of household food security status as a moderator in     the treatment of childhood obesity has never been examined. Thus, the investigators will     conduct a randomized controlled trial (RCT) examining Prevention Plus delivered by CHS     primary care providers on child zBMI in underserved children receiving their primary care at     CHS who are overweight and obese, and test the moderating effect of household food security     status on Prevention Plus delivered with and without caretaker goals   "
45949|NCT02684201|"     Individuals with upper-limb amputation usually have intact nerves within the residual limb,     and studies have demonstrated that electrical stimulation of those nerves can produce     sensations that appear to emanate from the amputated limb. In this study, investigators will     examine the sensations that are produced by electrical stimulation of these nerves at the     location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to     treat intractable back and limb pain, and the procedure includes a test phase in which     electrodes are temporarily placed under the skin near the spinal cord and removed at the end     of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the     upper back and neck, and stimulation will be applied over the course of multiple testing     sessions, lasting less than 30 days. The electrodes will be removed at the last day of     testing. During each testing session, electrical stimulation will be applied through the     electrodes and a series of tests will be performed to determine the types of sensations     produced by stimulation. In addition to producing meaningful sensations with electrical     stimulation, this study will also test the effect of stimulation on phantom limb sensations     and phantom limb pain.   "
46168|NCT02681328|"     The purpose of this study is to compare the performance of Afirma GEC and ThyroSeq v.2 in     indeterminate thyroid nodules to determine which test can allow more patients to avoid     unnecessary surgery and preserve quality of life.   "
45950|NCT02684188|"     Residents of rural and frontier counties experience significant disparities in health care     access and outcomes when compared to their urban counterparts. The organization of health     care delivery contributes significantly to these disparities. For rural residents with     multiple chronic conditions, transitioning along the continuum of care, between systems of     treatment and support, and between dispersed locations present significant challenges. One     critical challenge involves hospitalization for treatment because it requires travel to     locations at a significant distance from home and disrupts personal and family routines. The     transition back home is also problematic because discharge planning does not adequately     account for limited access to care in rural areas. Indeed, discharge planning has been     recently described as a black hole; fragmented and uncoordinated, and contributing to poor     outcomes and patient dissatisfaction. The specific aim of this research is to ascertain rural     patients' actual experience of the discharge planning process and to involve patients and     rural providers in designing and testing a contextually appropriate rural options discharge     model (ROADMAP) that improves patient outcomes and reduces re-hospitalizations.   "
45951|NCT02684175|"     The objective of this study is to compare remote and in-person audiological cochlear implant     candidacy evaluations (including audiological (hearing) testing and counseling sessions) in a     rural Appalachian region.   "
45952|NCT02684162|"     The goal of this clinical research study is to learn if giving donor lymphocyte cells and     SGI-110 will help control acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS)     in patients who have had an allogeneic stem cell transplant (using someone else's stem cells)     and have relapsed. The safety of this treatment will also be studied.   "
45953|NCT02684149|"     Study objective is to assess the interest of the relational touch before an arterial puncture     to reduce pain on patient in intensive care unit.   "
45954|NCT02684136|"     This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia     co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.   "
45955|NCT02684123|"     Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can     fall out on the scalp or elsewhere on the face and body.      Alopecia areata is an autoimmune skin disease, which means that the immune system is     recognizing the hair follicles as foreign and attacking them, causing round patches of hair     loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss     (alopecia universalis). The scalp is the most commonly affected area, but the beard or any     hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in     males and females of all ages, and is a highly unpredictable condition that tends to recur.     Alopecia areata can cause significant distress to both patients and their families.      In this study, the aim to assess the effects of a new treatment called apremilast in patients     with alopecia areata. A total of 30 patients will be included in the study, which will run     for a total of 52 weeks.   "
45956|NCT02684097|"     The purpose of this study is to assess whether tralokinumab can be a helpful treatment for     alopecia areata. This is a randomized, double-blind, placebo-controlled pilot study of a     total of 30 subjects with moderate to severe alopecia areata involving 30-100% of the scalp.     Expected is 50% of these subjects to have concomitant alopecia areata (AA) and atopic     dermatitis (AD). Subjects with AA alone (15 subjects) will be randomized (2:1) to either     receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks.     Subjects with concomitant alopecia areata and atopic dermatitis (15 subjects) will be     randomized separately in a 2:1 ratio to receive tralokinumab or placebo via subcutaneous     injection every 2 weeks for 24 weeks.   "
45957|NCT02684084|"     This is a 24-week, prospective, multi-center, open-label, randomized, investigator-initiated     pilot study to explore the effects of RBZ (0.5 mg) plus DEX implant (0.7 mg) PRN combination     therapy (n = 30) vs. DEX implant PRN monotherapy (n = 30) in pseudophakic eyes with     center-involved DME that have demonstrated prior incomplete response to 3-6 anti-VEGF     treatments.   "
45958|NCT02684071|"     The purpose of this research study is to test an experimental treatment method for recurrent     or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and     chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that     their use by themselves or together has not been approved by the U.S. Food and Drug     Administration for this usage.   "
45959|NCT02684058|"     The purpose of this study is to investigate the activity of dabrafenib in combination with     trametinib in children and adolescent patients with BRAF V600 mutation positive relapsed or     refractory high grade glioma.   "
45960|NCT02684045|"     The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in     the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.   "
46500|NCT02676960|"     The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI)     instrument on children aged 6 months, 1 year, and 2 years. This procedure is usually done     with sedation but the study will see if it can be done without sedation.   "
45961|NCT02684032|"     This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have     a dose escalation to identify the maximum tolerated dose (MTD) of the combination of     gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and     expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus     palbociclib/letrozole or palbociclib/fulvestrant.   "
45981|NCT02683759|"     Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an     imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of     treatment options are directed at attempting to control the chronic inflammation and     prolonging remission of clinical symptoms. Several studies have proven that curcumin has     well-established anti-inflammatory properties. However, curcumin has poor bioavailability and     prior studies have needed to use high concentrations in order to study the efficacy of the     product. The investigators propose that a bio-enhanced preparation of curcumin will require a     lower dosage to reach and affect its target tissue and will subsequently produce less adverse     side effects.   "
46135|NCT02681757|"     The aim of this study is to compare Mepitel Ag to Triple antibiotic ointment impregnated     Adaptic gauze when used with the soft cast technique to assess overall time to healing, yeast     infection rate and parents perception of pain level at time of dressing change on a scale of     1-10. The hypothesis is that Mepitel Ag in combination with the soft cast technique improves     wound healing in pediatric partial to deep partial thickness hand and foot burns by     decreasing the length of healing time, decreasing the risk of yeast infection, and decreasing     pain associated with dressing changes.   "
45962|NCT02684019|"     Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic     procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging     from conscious to deep sedation leading to general anesthesia.      Propofol sedation for (ERCP) procedures is the most popular current technique that has     generated controversy in the medical field. Propofol can be safely administered because of     its shorter half-life which results in a shorter recovery time than conventional sedation     (opioid and/or benzodiazepine) that makes it widely used for sedation in many     gastrointestinal procedures including ERCP. However, because of its narrow therapeutic     window, the level of conscious sedation can easily go deeper from moderately deep sedation to     near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and     apnea. Depth of sedation could be estimated better when target effect concentration of     propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a     specific range ensures additional safety during the procedure. Scores between 60-80 have been     recommended for sedation. Propofol requirement can be reduced with addition of adjuvants (eg.     Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have analgesic properties     with opioid and anesthetic sparing effects, without clinically significant respiratory     depression.      Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic     properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it     reduced their requirements intraoperatively and can help supplement analgesia     postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia     for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients .      Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel     blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal intravenous     (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology patients .      Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during     ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost     and complications together with more patient and doctor satisfaction in addition to better     patient outcome.   "
45963|NCT02684006|"     This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab     in combination with axitinib and of sunitinib monotherapy, administered as first-line     treatment, in patients with advanced renal cell carcinoma   "
45964|NCT02683993|"     Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible     ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part     of the study, using the study device. These subjects will be randomized into stone breaking     treatment or stone dusting.   "
45965|NCT02683980|"     Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for     surgery will undergo a single treatment for ablation of the prostate using the study     device.Follow up visits are scheduled for the day of release from the hospital and at 1 and 3     months post procedure.      The primary objective of this study is to explore Vaporization efficacy and safety when     treating PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with     recommended settings.   "
45966|NCT02683967|"     The trial aims to investigate whether acupuncture has an effect in increasing clinical     pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing     IVF treatment.   "
45967|NCT02683954|"     The association between endometriosis, obesity and nesfatin1.   "
45968|NCT02683941|"     This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the     efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of     well-differentiated, metastatic and/or unresectable, typical or atypical lung NETs This study     contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Extension Phase.     The DB Phase includes: Screening, Baseline and Treatment period. The OL Extension Phase will     consist of two periods: Treatment Period and Follow-Up Period.      The primary objective will be to compare the antitumour efficacy of Lanreotide Autogel/Depot     120 mg (LAN) plus Best Supportive Care (BSC) every 28 days versus placebo plus BSC, in terms     of progression free survival (PFS), measured by central review using Response Evaluation     Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects with     unresectable and/or metastatic well differentiated, typical or atypical lung neuroendocrine     tumours   "
45969|NCT02683928|"     The purpose of this study is to determine the effect of GBR 830 on biomarkers in AD/ eczema     to enable further studies in this indication.   "
45970|NCT02683915|"     This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term     and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of     serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.   "
45971|NCT02683902|"     To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo     associated with a reduced caloric diet on weight loss, glycemic control and regulators of     hunger and satiety in overweight or obese subjects with different degrees of glucose     tolerance, submitted to hypocaloric diet.   "
45972|NCT02683889|"     This study will evaluate the use of Acthar in patients to undergo renal transplantation and     will measure the rate of FSGS recurrence.   "
45973|NCT02683876|"     The purpose of this study is to identify metabolic signatures associated with malodor     conditions. The investigators will perform state-of-the art metabolomics tests and     bioinformatic data mining to explore if conditions leading to malodor can be screened by     metabolomic profiling of urine samples.   "
45974|NCT02683863|"     The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl     fumarate) its main bioactive metabolite, is capable of entering the central nervous system in     SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or the     amount of study drug in blood) will be tested to compare with PK samples, the amount of study     drug, in spinal fluid (CSF).   "
45975|NCT02683850|"     This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft     gel supplement for four weeks will increase the quality of life in adults with chronic pain.   "
45976|NCT02683837|"     The aim of this prospective randomized study is to evaluate the impact of peroperative     pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia.     All patients are anesthetized with sevoflurane and remifentanil. In the intervention group,     peroperative remifentanil infusion rate is guided by pupillometry. In the other group,     remifentanil infusion rate is guided according to hemodynamic data.   "
45977|NCT02683824|"     This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 positron     emission tomography (PET)/computed tomography (CT) in measuring response in patients with     pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta     [18F]-R01-MG-F2, are a family of membrane receptors that are overexpressed and attaches to     various proteins which sense and respond to contact events that occur at the cell surface and     may improve early detection of pancreatic cancer and improve patient selection for     anti-integrin alpha-v-beta 6 therapy.   "
46136|NCT02681744|"     The purpose of this study was to examine the effects of resistance training on sarcopenic     obesity in older women.   "
45982|NCT02683746|"     This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose,     study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic     response of albiglutide liquid drug product relative to the commercial lyophilized drug     product. The study will specifically evaluate the potential for immunogenicity (example     [e.g.] incidences of anti-drug antibodies [ADA]) and injection site reactions (ISRs).      Albiglutide is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long     half-life to permit once a week injection. Currently, lyophilized albiglutide and the diluent     are provided in a dual chamber cartridge (DCC), single-dose pen injector, requiring     reconstitution prior to use. A liquid formulation of albiglutide will enable the     commercialization of a liquid product in a single dose, ready-to-use prefilled syringe in an     auto-injector.      The primary hypothesis of this study is to test that liquid drug product will provide     glycemic control (as measured by HbA1c change from baseline) non-inferior to lyophilized drug     product for a period of 26 weeks of treatment in subjects with T2DM.      This study will comprise of 3 study periods : screening (2 weeks), treatment (26 weeks) and     for those subjects not entering the extension study a follow-up period (8 weeks).     Approximately 300 subjects will be randomized in a 1:1 ratio to either Albiglutide active     liquid auto-injector (LAI) plus Placebo lyophilized DCC pen injector (lyophilized DCC PI);     or, Albiglutide lyophilized DCC PI plus Placebo LAI.   "
45983|NCT02683733|"     Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an     imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of     treatment options are directed at attempting to control the chronic inflammation and     prolonging remission of clinical symptoms. Several studies have proven that curcumin has     well-established anti-inflammatory properties. However, curcumin has poor bioavailability and     prior studies have needed to use high concentrations in order to study the efficacy of the     product. The investigators propose that a bio-enhanced preparation of curcumin will require a     lower dosage to reach and affect its target tissue and will subsequently produce less adverse     side effects.   "
45984|NCT02683720|"     ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body     weight, muscle mass and function in malnourished elderly compared to standard care.   "
45985|NCT02683707|"     With potent analgesic properties, perceived hemodynamic benefits and limited alternatives,     opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting     peri-procedural pain or nitrate-resistant chest pain. However, large observational studies     suggest that opiate administration during ACS may result in adverse cardiovascular outcomes.     Complimenting this, a number of recent mechanistic studies have demonstrated delayed and     attenuated effects of oral dual anti-platelet therapy (DAPT) on platelet inhibition endpoints     among subjects receiving intravenous morphine. These studies support the hypothesis that     morphine delays the gastrointestinal absorption of DAPT medications. However, no data exist     on the impact of intravenous fentanyl, a systemic opioid analgesic routinely administered     during percutaneous coronary intervention (PCI) procedures, on the platelet inhibition     effects of DAPT. The investigators hypothesize that, similar to morphine, fentanyl     administered at the time of PCI will reduce and delay the effect of DAPT on platelet     function. As such, the primary aim of this study is to test the impact of intravenous     fentanyl on residual platelet reactivity by randomizing patients undergoing PCI to a strategy     of peri-procedural benzodiazepine plus non-systemic local analgesia or to the current     standard of benzodiazepine plus intravenous fentanyl. Given the critical need for rapid and     robust inhibition of platelet function during PCI, this trial has true potential to change     clinical practice, particularly if the investigators demonstrate reduced DAPT absorption and     elevated residual platelet reactivity among patients receiving fentanyl during PCI.   "
45986|NCT02683694|"     During the last decade optical coherence tomography (OCT) extended the possibilities for in     vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of     retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased     scanning speed and image-resolution provides more detailed information of microstructures in     the macula.      Epiretinal membrane (ERM), pseudomaculaforamen, maculaforamen and vitreomacular traction     syndrome are disorders involving the posterior pole of the eyeball with consecutive vision     loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle,     vitrectomy and membrane peeling is usually performed to remove traction and the ERM.      Different study groups showed that intraoperative use of SD-OCT is possible and improves the     Quality of Peeling surgery.   "
46501|NCT02676947|"     An open label study to assess the safety and efficacy of tocilizumab in group 1 pulmonary     arterial hypertension patients   "
45987|NCT02683681|"     This is a registry study. This is an observational, non-randomized, open, long-term project     to collect biological samples (e.g. tissue and blood samples) in addition to clinical     information and laboratory test results, from end-stage patients who undergo LVAD     implantation and/or heart transplantation. There are no investigational treatments, drug or     procedures associated with participation in registry activities.      Data collection will not immediately influence the course of treatment for any patient.   "
45988|NCT02683668|"     The aim of the study is to investigate the effect of tiotropium from different devices on a     panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with     mild-moderate COPD. Comparisons will be made between Tiotropium Handihaler 18 micrograms once     daily and Tiotropium Respimat 5 micrograms once daily   "
45989|NCT02683655|"     The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic     Esophageal Cancer.   "
46014|NCT02683330|"     Psychological difficulties, especially depression and anxiety are the most prevalent     non-motor symptoms in Parkinson's Disease (PD). Pharmacological treatments are not as     effective in PD. Mindfulness courses have received increased popularity and recognition as an     effective way to manage emotional states, and there is ever growing findings of the     effectiveness of mindfulness courses for people with long-term medical conditions. Two small     pilot studies have indicated that mindfulness courses can be helpful for people with PD in     improving symptoms of depression, language functioning and motor symptoms. The investigators     propose to deliver these courses remotely, through Skype video conferences, to make it more     accessible for people with mobility limitations and people who live in rural areas.   "
46015|NCT02683317|"     The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral     feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.   "
45990|NCT02683642|"     Invasive mould infections are emerging causes of morbidity and mortality in ICU patients.     This is attributed to prolonged ICU stay of critically ill patients with many co-morbidities.     Modern medicine and multiple intervention make the patients susceptible to these prevalent     moulds in the environment. In India the high frequency of IMIs in general has been attributed     to environmental and host factors prevalent in this region. Additionally sub-optimal hospital     care practice, frequent demolition and construction activities in the hospital make the     patients susceptible to IMIs. There is no multicentric study available in India describing     the epidemiology of IMIs in India. However, single center studies have reported distinct     epidemiology of IMIs in India. High incidence, different spectrum and risk factors are     possible unique features of IMIs in India.Early diagnosis and optimal therapy improve the     outcome of these patients. The conventional diagnosis including histopathology and culture     has limitations. The tests are of low sensitivity and long turnaround time. The major     challenge is collection of sample from deep tissue. Therefore majority of the patients in     ICUs of India are managed empirically against invasive fungal diseases. The galactomannan     test has improved the diagnosis of invasive aspergillosis. However, galactomannan test is not     well standardized in non-neutropenic patients. Beta-glucan test is used for early diagnosis     of invasive fungal infections other than mucormycosis. But the test is cumbersome for routine     laboratories and expensive. Both tests are not available in majority of Institutions of     India. PCR assay is not standardized and not performed routinely in any Institution.      Due these limitations in diagnosis, there is no uniform management protocol in ICUs of India.     To develop optimal management protocol, we need to know the epidemiology, the right patient     to treat, antifungal drug resistance, optimal drug and duration of therapy etc. The present     study will provide descriptive epidemiology, present status of diagnosis and management     practiced in India to treat IMIs in ICUs. This will help to find the suitable intervention     strategies to improve outcome of IMIs in India.This descriptive observational prospective     study will document the epidemiologic and clinical characteristics, as well as treatment and     outcome data, of patients with IMIs in ICUs in India over one year.   "
45991|NCT02683629|"     To assess the safety of xenotransplantation of NTCELL [immunoprotected     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed     over the duration of the study, by monitoring the occurrence of adverse events and serious     adverse events, including clinical and laboratory evidence of xenogeneic infection in     transplant recipients and their partners/close contacts. Subsequent safety follow-up will     include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.      To assess the efficacy of xenotransplantation of NTCELL [immunoprotected     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease. This will     be quantified by testing the secondary endpoints of the trial as described below (see     Endpoints/Outcome Measures).   "
45992|NCT02683616|"     Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80%     of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the     development of glucose intolerance and T2DM. The project is targeting the gap in providing     effective treatment of metabolic impairments associated with OSA, particularly T2DM. In     contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure)     on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are     disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP     treatment, as investigators suggested recently. Clearly, the search for additional     treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated     levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM     development. The aim of the study is to target adipose tissue and muscle dysfunction leading     to elevated FFA and develop thus novel pharmacological treatments based on lipolysis     inhibition and stimulation of FFA oxidation.   "
45993|NCT02683603|"     the management of Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR)     gram-negative bacilli (GNB) represent a real therapeutic dilemma in intensive care unit     (ICU). Colistin remains an effective agent against MDR GNB. However, because of its side     effects, mainly nephrotoxicity, other modalities than the intra venous (IV) route should be     tried. Several recent data emphasize the interest of inhaled route. The investigators purpose     was to evaluate the effectiveness and systemic toxicity of aerosolized colistin in ventilator     associated pneumonia.   "
45994|NCT02683590|"     For the replacement of the sternum, there is no consensus regarding the most appropriate and     most effective physiologically material. The use of ceramic implant offers significant     operational time saving and biocompatibility coupled with the strength of the material allow     us to realize a more natural operation, limiting the risk of infection and rejection.      Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic     implant on the respiratory capacity at 3 months post surgery.   "
45995|NCT02683577|"     The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a     single dose of telotristat etiprate in subjects with various stages of hepatic impairment     compared to healthy control subjects.   "
45996|NCT02683564|"     This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3     clinical study to evaluate the efficacy, safety and immunogenicity of BOW015     (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA)     despite Methotrexate (MTX) therapy.   "
45999|NCT02683525|"     Primary Objective      Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft     Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic     hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD     prophylaxis.      Secondary Objectives      The following descriptive secondary objectives will be studied:        1. Describe the tolerability and potential toxicity of sitagliptin.        2. Describe the cumulative incidence of grades II-IV acute GvHD by day +100.        3. Describe the cumulative incidence of grades III-IV acute GvHD.        4. Describe the engraftment kinetics of absolute neutrophil count and platelets.        5. Describe the incidence of infections occurring during the 100 days post-transplant.        6. Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant.        7. Describe overall survival.        8. Describe the incidence of chronic GvHD.        9. Describe the cumulative incidence of relapse of the primary hematological malignancy.   "
46000|NCT02683512|"     Database for information on individuals affected with glycogen brancher deficiency, also     known as glycogen storage disease type IV   "
46001|NCT02683499|"     The aim of the study is to assess the marginal fit following preparation finishing with     ultrasonic tips of porcelain veneers compared to the ordinary preparation using burs only.     Two-hundred and forty crowns prepared to receive porcelain veneers (in a split-mouth design).     On one side of the mouth, the prepared surfaces will be finished with ultrasonic tips.     Marginal fit is measured by a 'cement replica technique'.   "
46002|NCT02683486|"     The aim of this study is to assess whether an auto-titrating oxygen system can maintain     constant oxygen saturations (SpO2) in patients who are on long-term oxygen therapy (LTOT)     during activities of daily living.      Currently LTOT is provided at a constant fixed-flow rate e.g. 2 litres per minute all the     time after appropriate assessment. The flow rate is not changed during usual household     activities but is increased for walking. A number of studies have investigated the SpO2 of     patients on LTOT during the daytime in patients' homes. The results have shown that patients'     SpO2 decreases intermittently whilst they are doing activities of daily living such as     watching television, putting away the shopping, having a shower or bath and dressing and     undressing. This is a problem as it can lead to breathlessness, increased stress on the heart     and affect brain function. In order to correct the drop in SpO2 that patients experience     during everyday activities, the investigators have developed an oxygen system, which can     automatically change the amount of oxygen delivered depending on a patients' oxygen     saturations - an auto-titrating oxygen system. In this study, patients on LTOT will be asked     to simulate a series of activities of daily living twice: once whilst on their usual     fixed-flow oxygen therapy and once on the auto-titrating oxygen system. The activities will     be carried out in a hospital setting. During the activities, SpO2 will be recorded     continuously. The main outcome of interest from the study will be the SpO2 throughout the     study on fixed-flow oxygen and the auto-titrating oxygen system.   "
46003|NCT02683473|"     The purpose of this study is to measure energy expenditure during the first 3 months of life     in infants.   "
46004|NCT02683460|"     This study aims to compare the clinical results of patella resurfacing or not under subvastus     approach in total knee arthroplasty. Even though the excellent results of total knee     arthroplasty(TKA), there is persistent controversy over whether or not to replace the     patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons     always performed patella resurfacing during total knee arthroplasty but the others didn't do     that. It's up to surgeon's preference. There were several studies of patellar resurfacing or     not in TKA. But previous studies almost have been done under other approach, not a subvastus     approach.      This study prospectively randomized patients receiving bilateral TKA with patellar     resurfacing or not in each knee. Patients preference and clinical results was investigated in     both knee of same patients who received patellar resurfacing or not during minimum 2 year     follow up.   "
46005|NCT02683447|"     The proportion of older acute care physicians (ACPs) has been increasing. Ageing is     associated with physiological changes and research investigating how such age-related     physiological changes affect clinical performance is lacking. Specifically, Crisis Resource     Management (CRM) consists of essential clinical skills in acute care specialties which when     absent, can significantly impact patient safety. As such, the goals of this study are to     investigate whether ageing has a correlation with baseline CRM skills of ACPs and whether     ageing influences learning from high fidelity simulation.   "
46006|NCT02683434|"     The purpose of our study is to investigate the effects of Kinesio Taping application, which     is applied before the training period, on postural stability in young soccer players.   "
46007|NCT02683421|"     Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects     with active RA and concordance with clinical symptomology.   "
46008|NCT02683408|"     Diosmiplex is a product marketed for the management of diseases due to venous and     microvascular dysfunction. Raynaud's phenomenon is a disorder of characterized by spasm of     small arteries and impaired microvascular flow. This study will examine the effects of     diosmiplex on the frequency and severity of Raynaud's episodes in susceptible people.   "
46009|NCT02683395|"     The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics,     and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid     tumors (including lymphoma), acute myeloid leukemia (AML), or high-risk myelodysplastic     syndrome (MDS).   "
46010|NCT02683382|"     Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and     grittiness of eyes. The objective of this study is to investigate the effects of a     moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around     the eyes.   "
46011|NCT02683369|"     Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose     iron dietary supplement. The investigators seek to determine if the low-dose iron dietary     supplement will restore iron levels to normal range with fewer side effects than typically     experienced at higher doses of iron supplementation.   "
46024|NCT02683200|"     This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body     radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is     a specialized radiation therapy that delivers a single, high dose of radiation directly to     the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI     with SBRT may help doctors to highlight the tissues surrounding the tumor better.   "
46012|NCT02683356|"     Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to     preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain,     restore physiological vasomotion, and avoid late adverse events including restenosis and     scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest     non-inferiority in terms of safety and efficacy compared with metallic DES, several reports     have raised concerns regarding the scaffold thrombosis highlighting the importance of     technical considerations regarding lesion preparation and scaffold expansion. OCT offers the     opportunity to plan the procedure and optimize the implantation of BVS.      The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is     superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a     pre-procedural OCT and applying corrective measures in case of suboptimal treatment result as     indicated by OCT).   "
46013|NCT02683343|"     Carpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective     screening test. Many anatomical aspects of the syndrome have been studied including the     dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators     have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing     surgery for the condition. Assuming that this muscle may have a dynamic role in the     development of the condition, the investigators attempted to quantify this muscle using     ultrasound (US).      The purpose of this study was to devise a technique to evaluate the amount of muscle     overlying the carpal tunnel.      The hypothesis is that patients with carpal tunnel syndrome will have significantly more     muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.   "
46137|NCT02681731|"     Through a series of sequential analyses, retrospective database exploration looking for     linkages and associations between the use of processed electroencephalogram (EEG) and/or     cerebral saturation monitoring and patient outcomes post-cardiothoracic surgery will be     explored.   "
46016|NCT02683304|"     The main objective of this pilot study is to make a first assessment of the discriminating     ability of a dosage of S100B protein for differential diagnosis between primary headaches and     secondary headaches.      For this, the investigators will compare serum S100B protein between two groups of headache     patients presenting at the emergency department: 1 group of primary headache patients and 1     group of secondary headache patients.      If the difference between the two groups proves potentially discriminating, the investigators     will seek to determine the discriminating ability of the S100B protein by calculating the     area under the ROC curve.      The reference diagnostic will be set at one month across the entire clinical picture and     imaging by an expert committee composed of a neurologist, a radiologist and an emergency     physician.   "
46017|NCT02683291|"     There is no consensus on the best immunosuppressive regimen in elderly people. The aim of     this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in     elderly kidney transplant recipients. The investigators will conduct a single-center     prospective randomized study comparing the combination of tacrolimus with sirolimus at     reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate     (tacrolimus + mycophenolate group). The investigators will include all kidney transplant     patients over 60 years of age. The investigators will evaluate estimated glomerular     filtration rate and incidence of cytomegalovirus in 12 month follow-up.   "
46018|NCT02683278|"     This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful     awareness and acceptance treatment (M), and arthritis education as an active control     condition (E) on mental and physical health outcomes among adults with chronic pain due to     fibromyalgia (FM).   "
46019|NCT02683265|"     This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is     designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD.     Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD     (combined, inattentive or hyperactive/impulsive) will be enrolled.      There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include     washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an     eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a     6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR®     responders, and a two-week follow-up call after study completion or early discontinuation to     assess for ongoing adverse events and concomitant medications.      Up to 150 subjects will be enrolled in this trial to allow for subjects who improve     significantly during the behavior training phase and drop-outs. Once 74 subjects have     completed the double-blind phase, no additional subjects will be enrolled in the trial.     Subjects who are already enrolled at that time will be allowed to complete the trial.      The primary objective of this study is to establish that an optimal dose of Aptensio XR® will     result in a significant reduction in ADHD symptoms compared with placebo in children ages 4     to under 6 years   "
46020|NCT02683252|"     Study on quantitative perfusion parameters acquired on MR imaging of patients with     non-tumoral pathology of the musculoskeletal system.   "
46021|NCT02683239|"     This study of up to 7,000 participants will further characterize the safety profile of     fasinumab.      A subset of approximately 1,000 participants at select sites will also participate in a     sub-study to characterize the efficacy of fasinumab.   "
46022|NCT02683226|"     The purpose of this study was to determine whether dual treatment with metformin and     alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in     the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin     resistance and beta cell function.   "
46023|NCT02683213|"     The purpose of this study is to investigate whether routine administration of fluoxetine 20mg     once daily in the 6 months initiated during the acute stroke improves the patient's     functional outcome.      EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind     placebo controlled trial with broad entry criteria and follow up at 6 and 12 months.      The anticipated numbers of participants is 1500 at 30 centers in Sweden. As of 31 January     2016, EFFECTS has recruited 244 participants at 24 active centers.   "
46077|NCT02682511|"     The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study     is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic     SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).   "
46025|NCT02683187|"     This study is being done to determine the role of a hormone, glucagon-like peptide 1 (GLP-1),     on insulin secretion and to study how GLP-1 works in in diabetic individuals as compared to     non-diabetic individuals, under fasting conditions.      GLP-1 is a naturally occurring hormone made in the intestines. It is released into the     circulating blood after eating and helps to control the blood glucose levels by increasing     insulin secretion by cells in the pancreas. However, the exact method by which GLP-1 causes     insulin secretion and how GLP-1 activity is changed in diabetic persons remain unclear. This     research is being done to address these questions and better understand the function of     GLP-1.      In this research, the investigators will use a synthetic form of Exendin-9 to determine the     effects of GLP-1 on insulin secretion in diabetic and non-diabetic persons. Exendin-9 acts as     a blocker of GLP-1 action, allowing us to study the specific effects of the GLP-1 hormone.     Exendin-9 is an investigational compound, which means it is still being tested in research     studies and is not approved by the U.S. Food and Drug Administration (FDA).      In this study, the investigators will also use the drug Sitagliptin, which is an FDA-approved     drug for the treatment of type 2 diabetes mellitus. In this study, use of Sitagliptin is     considered investigational since it is not being used for treatment of diabetes but is     instead being used to understand how GLP-1 works and to better understand how medications     like Sitagliptin work in patients with type 2 diabetes mellitus.   "
46138|NCT02681718|"     The purpose of this study is to compare the efficacy of three approaches in diabetes     management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual     hospital-based care. The goal is to determine the most cost-effective method of diabetes     management among an economically-disadvantaged, minority population.   "
46139|NCT02681705|"     This phase II trial is studying giving radiation therapy together with combination     chemotherapy after surgery to see how well it works in treating children with newly diagnosed     medulloblastoma.   "
46026|NCT02683174|"     Syncope is a common Emergency Department (ED) presentation but the underlying diagnosis is     not apparent in 60% of patients after assessment and serious adverse event rate is 7% at one     month with most having acute cardiovascular events, also more likely to be unexplained after     ED assessment. Many cardiovascular events are due to arrhythmia, difficult for clinicians to     diagnose, as examination and Electrocardiogram (ECG) findings may both be normal and symptoms     have resolved by the time the patient gets to the ED. Currently establishing a cardiac     arrhythmia as the cause of syncope rests on correlating the arrhythmia with symptoms using     monitoring devices such as Holter but these all have significant drawbacks. The clinical     challenge in the ED is therefore to identify the moderate and high-risk patients and refer     them for further investigation and monitoring if appropriate. The logistics of arranging     follow up within a timely period of the patient's ED visit is often problematic for a variety     of reasons including availability of timely specialty outpatient appointments, a lack of     consensus of the specialty to whom the syncope patient should be referred (cardiology,     medicine, neurology, general practice) and availability of Holter and other monitoring     devices. For this reason most high and medium risk patients are admitted to hospital.      Previous syncope clinical decision rules have not been well adopted due to their lack of     sensitivity and specificity probably due to the varied and heterogeneous nature of     potentially serious causes. However, the majority of patients with syncope have no serious     underlying pathology and do not require hospitalisation. Rather than continued attempts at     risk stratification of outcome based on presentation, more research is required into how we     can better improve diagnosis and therefore treatment in order to provide improved patient     benefit. We believe that ambulatory patch monitoring will allow better and earlier arrhythmia     detection and plan to assess the ability of a 14-day ambulatory patch to detect serious     arrhythmic outcomes at 90 days.   "
46027|NCT02683161|"     The study will evaluate the feasibility of integrating an intensive pre- post-surgical     smoking cessation intervention into a hospital setting, and assess measures of postsurgical     recovery as a function of smoking cessation status.   "
46029|NCT02683135|"     Large spikes in blood glucose experienced after meals in people with type 2 diabetes are     known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood     glucose control in people with type 2 diabetes but it is unclear how these two strategies     interact to affect blood vessel function and inflammation. We will examine how following a     short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts     markers of blood vessel function and inflammation. We will also examine how a single low     carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control     and blood vessel function. Findings will help determine the best lifestyle approach for     improving cardiovascular health in type 2 diabetes.   "
46030|NCT02683122|"     The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial     pneumonia in intensive care is not yet defined.   "
46031|NCT02683109|"     This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled     study.      Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of     either FDC of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of     tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose     is to show non-inferiority between the FDC and the free combination of tiotropium and     olodaterol in patients with COPD.   "
46032|NCT02683096|"     Our central hypothesis is that screening newborn infants who either fail their newborn     hearing test or have a diagnosis of small for gestational age (SGA) will lead to better     identification of infants with congenital CMV infection and enhanced rates of therapeutic     intervention. This has the potential to significantly improve outcomes for infants with this     common viral infection. This particular cohort of patients have not been well studied locally     or regionally. In addition, in view of current legislation that will be effective in January,     2016 this is a timely project that will provide preliminary data for future statewide     recommendations around CMV testing of newborn infants. This will be a pilot/feasibility study     to obtain preliminary data for an Illinois Department of Public Health (IDPH) Title V grant.     Although not guaranteed, preliminary discussions with the IDPH are highly encouraging giving     the statewide interest in this topic.   "
46033|NCT02683083|"     Primary purpose of the clinical study is to evaluate the safety, biodistribution and     radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with     HER2+ breast cancer.      Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB     Anti-HER2 VHH1 in patients with HER2+ breast cancer.   "
46034|NCT02683070|"     Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general     anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this     study, the investigators will enroll male patients undergoing elective prostate surgery with     urinary catheterization after anesthetic induction, and compare the efficacy of pudendal     nerve block (PNB) and intravenous tramadol in prevention of CRBD.   "
46035|NCT02683057|"     Our study addresses a previously selected population or by physical activity but not for     semen quality semen donor candidates donation program within the clinic.      Total physical activity was analyzed according to the universally accepted international     physical activity questionnaire (IPAQ) The existence of confounding factors associated She     purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters     determinations will be made to exercise.   "
46036|NCT02683044|"     Randomized, experimental, non-inferiority clinical trial to determine the comparative     effectiveness and safety of two protocols used in the treatment of Erectile Dysfunction (ED)     with Low-Density Shock Waves (Li-ESWT), for patients seen at the Boston Medical Group's     Bogota center. Protocol 1: Consists of five sessions, one per week, with 3000 pulses at 0,15     mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the     body of the penis and 1000 pulses at its base. Total duration: 5 weeks. Protocol 2: Consists     of six sessions, two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4     Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600 pulses     at its base. Total duration: 3 weeks.      Outcome variables: Erection Hardness Score (EHS). International Index of Erectile Function,     5-item version (IIEF-5). Penile blood flow.      Evaluation at 1, 3 and 6 months after completing each of the Li-ESWT protocols.   "
46037|NCT02683031|"     We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+     ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear     stage i.e: cleavage failure to find out if there is any improvement in embryonic     developmental stages.   "
46038|NCT02683018|"     The use of cannabis for severe medical conditions is being legalized in different states,     increasing the mandate to make cannabis legal for medically ill patients. However, there is a     lack of placebo-controlled studies investigating the efficacy of cannabis. Dronabinol     (synthetic, oral Δ-9-THC) is FDA approved for the appetite stimulation in AIDS-related     anorexia and nausea/vomiting in chemotherapy patients. Nabilone, a synthetic analogue of THC,     is approved for nausea/vomiting in chemotherapy patients. These medications have been found     to be effective for these disorders, but there remains an interest in studying cannabis,     partly due to the numerous cannabinoids contained within the cannabis plant. Among these is     cannabidiol, which does not produce subjective effects, but has been shown to have potent     anti-inflammatory effects. In addition, there is data indicating that cannabidiol may be     effective for neuropathic pain and nausea/vomiting.      The goal is to investigate the effects of high CBD/low THC cannabis on symptoms such as pain,     nausea/vomiting, and quality of life in seriously ill participants. While there is data     beginning to emerge that cannabis may have a beneficial effect on these symptoms, there are     few placebo controlled, double-blind studies. Additionally, the administration of cannabis to     medically ill patients may be limited by its subjective effects, such as anxiety,     intoxication, or paranoia. Most cannabis available today has high levels of Δ-9-THC (about     15%). By using cannabis that is high in CBD, but low in - Δ-9-THC, it is hypothesized that     some of these effects can be avoid, while maximizing the therapeutic effects, if any.   "
46039|NCT02683005|"     Sofosbuvir and ledipasvir (LDV/SOF) are new directly acting antiviral drugs for the treatment     of hepatitis C (HCV) that are highly effective, orally administered, well tolerated and     preclinical evaluations in animal models indicate safe administration during pregnancy. This     project will evaluate the safety and pharmacokinetics of antenatal LDV/SOF treatment for 12     weeks during the second and third trimester. If proven to be effective, antenatal treatment     of HCV with LDV/SOF will prevent maternal HCV-related liver disease, perinatal transmission     of HCV, and community transmission of HCV.   "
46040|NCT02682992|"     The overall purpose of this study is to examine the efficacy of prophylactic low-level laser     therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients     receiving combined modality therapy consisting of chemotherapy and radiation therapy for head     and neck cancer.   "
46041|NCT02682979|"     Demographically, the geriatric population is expanding. It is also increasingly found in the     emergency services.However, emergency services are not designed to accommodate these     patients, whose needs are specific. This population is defined by complex physical and     psychosocial needs, included in a comprehensive geriatric assessment too complex to be     carried out in the emergency services.      Many publications focused on ways to prevent potentially avoidable visits to geriatric     patients in emergency services. People rely upon a therapeutic limitation code established     for these patients to determine the intensity of the care that may be given to them. However,     few geriatric patients arriving in the emergency services were already given such a code.      As a consequence, the intensity of the care given to these emergency patients is influenced     by the perception of the functional and cognitive status of the patient, even if part of this     perception is incorrect. Moreover, it is also well established that the outcome of geriatric     patients with severe pathologies at admission is often poor and that there is a need to find     alternatives to the intensive treatment offered.      The goal of this study will be to determine the prevalence of the presence of a therapeutic     limitation code in geriatric patients at hospital admission / admission to the emergency     department, and when they leave the hospital. This will be carried out for all geriatric     patients residing or placed in nursing homes at the end of the hospitalization.The     investigators postulate that establishing a therapeutic limitation code for these fragile     patients, before they leave the hospital for a nursing home, would reduce the number of     future admissions of these patients in the emergency department.   "
46042|NCT02682966|"     This is a prospective study in patients who undergo routine postoperative troponin assessment     after major elective noncardiac surgery. Two groups are created based on postoperative     troponin levels: Postoperative myocardial injury (PMI) group with troponin I levels ≥ 60 ng/L     and a control group with troponin levels < 60ng/L. Our objective is to determine the     association of PMI with CAD and PMI with pulmonary embolism using coronary computed     tomography angiography in patients undergoing major elective noncardiac surgery.   "
46078|NCT02682498|"     This study seeks to determine whether a new sustained-release local anesthetic solution     (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after     surgery will decrease opioid consumption and adverse events in opioid-tolerant patients     presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study)     group will use less opioid in the first 48 hours post-operatively than the control group.   "
46043|NCT02682953|"     This is a pilot study to evaluate the efficacy of hyperbaric oxygen therapy (HBO2) for     mobilizing hematopoietic progenitor cells from bone marrow to blood. These cells are needed     for patients to undergo bone marrow transplantation and some patients fail to respond to     current best chemotherapy. HBO2 has been shown to trigger stem cell mobilization in other     patient populations and we plan to investigate whether this intervention can act in concert     with chemotherapeutic agents to allow poor mobilizer patients to achieve successful bone     marrow transplantation. Twenty patients will be identified by participating hematologists who     have failed to respond adequately to chemotherapy. When it is deemed appropriate to attempt     an additional stem cell mobilization protocol, these patients will be administered     chemotherapy as determined by their primary treating hematologist and additionally receive     daily HBO2 (2.5 atmospheres absolute [ATA] for 90 minutes) for 3-8 days. At intervals, blood     samples will be obtained as is the normal transplantation protocol practice to assess whether     adequate stem cells are present in blood for the patient to proceed with transplantation. The     project is anticipated to take one year to complete.   "
46044|NCT02682940|"     A single center pilot study assessing the Vigilant Diabetes Management System for the     prevention of recurrent mild to moderate hypoglycemia in type I diabetes patients.   "
46093|NCT02682303|"     Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on     balance control in subjects with chronic ankle instability.      Material and methods: Twenty-eight individuals successfully completed the study protocol, of     whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were     assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure     postural sway we used computerized dynamic posturography with Sensory Organization Test and     Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the     composite Sensory Organization Test score, the composite Sensory Organization Test strategy     and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the     centre of gravity sway velocity with open eyes and close eyes during the US test.   "
46046|NCT02682914|"     The main objective of this study is to determine the risk factors and etiologies of ischemic     stroke in Korean young adults. Both well-documented risk factors and little known life-style     related risk factors such as life-style habits, psychological distress including occupational     distress, perceived stress and depression will be evaluated by comparison with healthy     controls using a structured questionnaire. Secondary objectives are to determine stroke     outcomes such as mortality, recurrent vascular events and post-stroke epilepsy in these     patients.   "
46047|NCT02682901|"     The main objective is to demonstrate the effects of early dopaminergic activation on the     autonomic nervous system in subjects with newly diagnosed vs. established type 2 diabetes.     The primary endpoint is the effect of Bromocriptine QR on changes in autonomic function     measured by assessing sympathetic and parasympathetic function using conventional measures of     autonomic function, including power spectral analysis of heart rate as well as peripheral     autonomic function using sudorimetry and laser scanning of peripheral microvascular autonomic     control.   "
46048|NCT02682888|"     to examine the association between trait and defensive network connectivity and the     modulatory effect of oxytocin on it   "
46049|NCT02682875|"     The study evaluates with Artificial Neural Network (ANN) of pain scales in children. Pain of     these patients' will be evaluated by many pain scales in the postoperative period.   "
46050|NCT02682862|"     Single centre, open-label, random order, cross-over trial, recruited over a period of     approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn     subjects may be replaced.      This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in     smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test     called impulse oscillometry.   "
46051|NCT02682849|"     The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active     Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac     surgery.   "
46052|NCT02682836|"     Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life     is a major goal of care. There is a strong body of evidence that exercise can reduce or     manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base     is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a     home-based, self-directed walking program can have similar benefits in women with an MBC     diagnosis. The primary objective is to evaluate whether engagement in physical activity will     reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary     endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study     participants and measuring changes between baseline, 3 months and 6 months in additional     quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and     sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30     patients. Findings from this study will provide preliminary data for a grant application to     test the physical activity intervention in a randomized controlled trial (RCT) in a large     sample of women with metastatic breast cancer.   "
46053|NCT02682823|"     This study is designed to evaluate RLHFs concerning administration of the tocilizumab     autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving     subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle     safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be     assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and health     care professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study     participants. The study will enroll approximately 45 participants with RA across three     cohorts. Group 2 will also include 15 paired CGs to administer the injection, and Group 3     will include 15 paired HCPs to administer the injection. With an expected drop-out rate of     20%, the target enrollment (to achieve a final sample/ratio of 45:15:15) will be 95     individuals overall.   "
46054|NCT02682810|"     This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the     Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.   "
46502|NCT02676934|"     the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for     living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as     effective as FGF control with less cost and more operator satisfaction.   "
46055|NCT02682797|"     Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a     splitting of the neurosensory retina occurs usually in the inferior temporal. Patients     usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer     hole is considered high risk factor for development of a schisis detachment. The most     important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary     treatment is provided. In clinical examination, both can appear very thin and transparent.      Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and     regular follow-up controls have to be conducted for sufficient recognition of progression.   "
46094|NCT02682290|"     This is a proof of concept study. The aim of this study is to assess a device measuring     rheological properties of human sputum of four populations :        -  10 patients with Broncho Chronic Obstructive Pulmonary Disease (COPD)        -  10 patients with asthma        -  10 patients with cystic fibrosis        -  10 healthy volunteers.   "
46095|NCT02682277|"     The polyglucosamine, specification L112, is a medical device and in this clinical trial used     for weight reduction in moderately obese participants following a long term treatment lasting     12 months. The rationale for this study is to show that overweight can be reduced by taking 2     times daily 2 tablets with the main meals.   "
46056|NCT02682784|"     Over one million individuals in the United States meet criteria for cocaine use disorders.     Relapse rates are highest among cocaine-dependent (CD) populations. Social stress is a     significant risk factor for relapse. Data from human neuroimaging studies suggest that     top-down prefrontal cortical inhibition of amygdala activity controls emotional responses     to social stimuli. A growing literature suggests that hypoactivity in the medial prefrontal     cortex coupled with increases in amygdala activity underscore the vulnerability of CD     individuals to relapse. Neuroimaging studies of corticolimbic network activity (functional     connectivity) have been conducted in CD subjects at rest. Compared with healthy controls, CD     subjects exhibited lower corticolimbic connectivity and the degree of corticolimbic     uncoupling was associated with time to relapse. Studies measuring corticolimbic connectivity     during exposure to a social stress task in CD subjects could provide critical insight into     the neurobiologic mechanisms that underscore the sensitivity of CD individuals to social     stress. Moreover interventions that improve corticolimbic connectivity in CD subjects may be     effective therapeutic strategies for preventing relapse in CD populations. Oxytocin (OT) is     an anxiolytic neuropeptide that attenuates amygdala responses to aversive social cues. In     order to better understand the neurobiologic mechanisms that control emotion-related behavior     in CD populations, we propose a double-blind placebo (PBO) controlled study using blood     oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) to measure (1)     corticolimbic functional connectivity during the Montreal Imaging Stress Task (MIST) and (2)     amygdala activity in response to an implicit facial affect recognition paradigm in groups of     CD individuals (CD n=80) and healthy non-dependent controls (HC, n=80). Prior to the scanning     session, participants will receive either intranasal OT (24 IU) or PBO spray (n=40 per     treatment group). The order of the tasks will be counterbalanced.   "
46057|NCT02682771|"     Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory     function and lung function, leading to reduction in lung volume and capacity. Such     dysfunctions are worsen after bariatric surgery to be associated with factors inherent to     this procedure. The objective of this study was to evaluate and compare the effects of the     application of bilevel positive airway pressure and exercises with inspiratory pressure with     linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength,     respiratory muscle strength and prevalence of pulmonary complications after bariatric     surgery.   "
46058|NCT02682758|"     The influence of xenon anaesthesia on transpulmonary pressure and tidal volume distribution     will be investigated in a prospective cohort study in 10 patients of normal weight and 10     obese patients undergoing routine xenon-based, general anaesthesia for surgery.   "
46059|NCT02682745|"     The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine     after single oral administration of TALION tab, a IR formulation of bepotastine as reference     drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults.     Additionally the safety and tolerability of two drugs will be evaluated.   "
46060|NCT02682732|"     The current understanding of acute myeloid leukemia (AML) is that one site of bone marrow     (BM) sampling serves as a window that represents all AML cells distributed throughout the BM,     an assumption that has yet to be questioned. Simulation in mice led to inconsistent     representation of the full BM, which can incorrectly suggest the absence of leukemic cells.     Positron-emission tomography (PET) scan can detect areas of high metabolic activity in the     body using for instance a radioactive sugar. In one report, its use in human AML has provided     proof-of-principle evidence of unequal distribution of AML cells in BM. Accordingly, the     alternative hypothesis is to test if PET scan can demonstrate if BM geography can alter AML     cells spread and home them as distinct areas rather than uniform spread as if they are     distributed in liquid state.   "
46061|NCT02682719|"     The purpose of this study is to determine whether LCZ696 (valsartan/sacubitril) is safe and     has beneficial effects on the heart and blood vessels in patients with high blood pressure     and/or diabetes or other risk factors for developing heart failure (elevated levels of     natriuretic peptide and elevated left atrial volume index). Patients will be randomized to     receive LCZ696 or valsartan (and matching placebo) for 18 months to assess the impact on left     ventricular diastolic function.   "
46062|NCT02682706|"     Brown adipose tissue (BAT) is unique in its capability to convert chemical energy directly     into heat. Active BAT increases energy expenditure and can thereby counteract obesity and     insulin resistance. Currently, the imaging method of choice to assess BAT morphology and     function is 18F-FDG-PET/CT which is expensive and exposes patients or healthy volunteers to     ionizing radiation, thus impeding larger prospective studies.      Magnetic resonance imaging (MRI) could constitute a suitable alternative and preliminary     small-scale studies are promising.      The overall aim of this research proposal is to develop reliable magnetic resonance imaging     techniques to facilitate the study of brown adipose tissue in human adults, specifically in     the context of endocrine disease.      Specifically, investigators want to        1. Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold          induced nonshivering thermogenesis as a measure of BAT activity.        2. Assess the intra-individual variance of BAT volume measured by MRI.        3. Evaluate direct measurement of BAT temperature by functional MRI.   "
46132|NCT02681796|"     The rationale for this study is to investigate the benefits of epidural analgesia in     pancreatic resections in a prospective, single blind, randomized control trial. This study     will evaluate both short and long-term outcomes related to epidural analgesia, providing a     longitudinal and comprehensive perspective to the advantages and disadvantages of this     technique. The investigators hypothesize that the use of epidural analgesia reduces a     patient's consumption of morphine or morphine-equivalent in the post-operative period     following pancreatic resections.   "
46063|NCT02682693|"     Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and     inhibits metastatic progression in multiple mouse models.      In a retrospective analysis it could be demonstrated that elevated expression of RANK was     found in 14.5% of patients overall, with a significant predominance in patients with     hormone-receptor-negative disease. Expression of RANK was associated with a higher     pathological complete response rate but with a shorter disease-free and overall survival. The     ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone     health, and can be administered without added toxicity.      It appears therefore reasonable to test denosumab, a clinically available antibody against     RANKL in patients with hormone-receptor-negative primary breast cancer as an adjunct to     neoadjuvant chemotherapy for its ability to increase pCR rate and improve outcome in relation     to the expression of RANK.   "
46064|NCT02682680|"     A 24-week, randomized, open-label study investigating the efficacy, safety and tolerability     of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline     statin therapy in patients with type 2 diabetes mellitus (T2DM) who are not at target for     glycated hemoglobin (HbA1c) (> 7.0%) and low-density lipoprotein (LDL) cholesterol (> 2.0     mmol/L).   "
46096|NCT02682264|"     The primary objective of this study is to determine the long-term safety of CB-03-01 cream,     1% applied twice daily for an additional nine months in study participants with acne vulgaris     that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.   "
46097|NCT02682251|"     An interventional study to empower congestive heart failure patients who have a cardiac     resynchronization therapy-cardiac implantable electronic device (CRT-CIED) by using a     personal health record (PHR) to directly message them their device data and send alerts based     on percent left ventricular pacing.   "
46065|NCT02682667|"     Background:      Cancer has a major impact in the United States and across the world. In 2015, over 1.5     million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from     people with cancer or a pre-malignant condition. They hope to develop more effective     treatments.      Objective:      To better understand the biology of malignancies and why certain cancers respond differently     to treatment.      Eligibility:      Adults at least 18 years old with cancer or a pre-cancerous condition.      Design:      Participants will be screened with a medical history, physical exam, and blood tests. Their     diagnosis will be confirmed by the NCI Laboratory of Pathology.      Participants will send tissue blocks or slides from their original tumor biopsy.      At least once, participants will have a medical history, physical exam, and blood and urine     tests.      Participants may have the following tests. They may have them more than once:      Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample     cells are taken out. The rest of the blood is returned by a needle in the other arm.      Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the     hipbone. Bone marrow will be taken out through the needle.      Piece of cancer tissue taken by a needle and syringe.      Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission     tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a     machine that takes pictures.      A small piece of skin removed.      Participants will be contacted by phone once a year to find out how they are doing.   "
46066|NCT02682654|"     This study will look to examine the overall performance of a custom fit knee or ankle brace     as a means of providing ankle or knee joint support in subjects that have determined the need     for bracing based upon chronic joint instability and/or joint swelling and pain following     daily activity.   "
46067|NCT02682641|"     Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in     combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL.      An extensive biological study will be conducted in order to further characterize this     population of MCL patients and evaluate the response obtained with the mutational profile of     the tumor.   "
46068|NCT02682628|"     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.   "
46069|NCT02682615|"     Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the clinical     goldstandard of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of     different potential interference factors to the accuracy of measurement (changing     concentration of norepinephrine, generally severity of the basic disease - APACHE II score).   "
46070|NCT02682602|"     The objective of this study is to analyze subjects having a normal hip and compare the in     vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased     hip and then later post-operative to their implanted hip. Ten subjects will have a normal     hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will be     re-analyzed at six months post-operative after implantation of a THA.   "
46071|NCT02682589|"     Randomized, multicenter, phase III trial to compare the short and long outcomes of     laparoscopic CME with open CME in treating patients with locally advanced colon cancer.   "
46072|NCT02682576|"     The objective of the study is to define the analytical repeatability of quantifying     flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using     upper arm cuff occlusion.   "
46073|NCT02682563|"     Background:      Worldwide, diabetic nephropathy or Diabetic Kidney Disease (DKD), is the most common cause of     chronic and end-stage kidney disease. With the increasing rates of obesity and type 2     diabetes (T2DM), many more patients with DKD may be expected in the coming years. DKD is a     multi-factorial condition, involving factors such as obesity, chronic hyperglycemia, advanced     glycation end products, oxidative stress, pro-inflammatory cytokines, systemic- and     glomerular hypertension. Large-sized prospective randomized clinical trials suggest that     intensified glucose and blood pressure control, the latter especially by using agents that     interfere with the renin-angiotensin-aldosterone system (RAAS), may halt the progression of     DKD, both in type 1 diabetes and T2DM. However, despite the wide use of     angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, a considerable     amount of patients develop DKD during the course of diabetes, indicating an unmet need for     renoprotective therapies. Sodium-glucose linked transporters (SGLT-2) inhibitors are novel     glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic     actions 'beyond glucose control', including reduction of blood pressure and body weight. In     addition, SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular     pressure and albuminuria in rodents and type 1 diabetes patients. In rodents, SGLT-2     inhibitors also improved histopathological abnormalities associated with DKD. To date, the     potential renoprotective effects and mechanisms of these agents have not been sufficiently     detailed in human type 2 diabetes. The current study aims to explore the clinical effects and     mechanistics of SGLT-2 inhibitors on renal physiology and biomarkers in metformin-treated     T2DM patients with normal kidney function.      Hypothesis:      Treatment with the SGLT-2 inhibitor dapagliflozin, as compared to the sulfonylurea (SU)     derivative gliclazide, may confer renoprotection by improving renal hemodynamics, and     decreasing blood pressure and body weight in type 2 diabetes.      Study Design:      A phase 4, monocenter, randomized, double-blind, comparator-controlled, parallel-group,     mechanistic intervention trial to assess the effect of 12-week treatment with the     sodium-glucose linked transporters (SGLT)-2 inhibitor dapagliflozin versus the SU gliclazide     on renal physiology and biomarkers in metformin-treated patients with type 2 diabetes     mellitus (T2DM)      Study Endpoints and methods:      Renal hemodynamics, i.e. glomerular filtration rate (GFR, ml/min) and effective renal plasma     flow (ERPF, ml/min) will be measured by the gold-standard inulin- and para-aminohippurate     (PAH) clearance methods, respectively, during both euglycemic- and hyperglycemic clamp; renal     tubular function will be measured by 24-hour urine sodium, potassium, chloride, calcium,     magnesium, phosphate and urea and glucose; markers of renal damage will include urinary     albumin excretion, neutrophil gelatinase-associated lipocalin and kidney injury molecule-1;     blood pressure will be measured using an automated oscillometric blood pressure device     (Dinamap®); body anthropometrics, including body weight, height, body-mass index and waist     circumference, and body fat contents (by bio-impedance analysis) will be measured; blood     samples will be obtained to determine glycemic variables, lipids and markers of inflammation;     systemic hemodynamic variables (including stroke volume, cardiac output and total peripheral     resistance) will be measured by continuous beat-to-beat hemodynamic monitor (NexFin®); heart     rate will be determined by oscillometric blood pressure device; microvascular function will     be measured by capillary videomicroscopy and Laser Doppler; arterial stiffness will be     assessed by applanation tonometry, (SphygmoCor®); additional urine, blood and feces will be     collected for conditional determination of various markers of renal damage/function,     inflammation, oxidative stress and (cardiovascular)-biomarkers and DNA; cardiac autonomous     nervous system (CANS) will be measured by electrocardiography and NexFin®; insulin     sensitivity will be measured by glucose infusion during the euglycemic clamp (M-value);     beta-cell function will be measured by quantification of insulin secretion during the     hyperglycemic clamp.      Expected results:      This active-comparator controlled mechanistic intervention study, using state-of-the-art     methodology will expand our knowledge regarding the potential renoprotective effects of     SGLT-2 inhibitors in human T2DM. The investigators hypothesize that SGLT-2 inhibitors may     confer renoprotection by improving renal hemodynamics, and decreasing blood pressure and body     weight, all important factors in the development of DKD. Ultimately, the investigators expect     that this study will contribute to guiding clinicians in their decision-making process of     individualizing therapies for T2DM patients at risk for, or suffering from, DKD.   "
46074|NCT02682550|"     The NTF_PT_2014 multicenter study aims to collect, store, and analyse plasma and serum from     polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address 1)     how trauma modulates the release of danger molecules, inflammatory mediators, coagulation     factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic     response and regenerative potential on an organ-, cell, and molecular level, and 3) how could     a specific organ- and immune-monitoring predict the clinical outcome.   "
46075|NCT02682537|"     Assessment of resting energy expenditure (REE) by indirect calorimetry (IC) in 1400 healthy     individuals for arithmetical transformation into an bedside tool to estimate energy     requirements in dietary practice (BASAROTs). A multinational, multicenter, prospective     cross-sectional study.   "
46076|NCT02682524|"     A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical     trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of     patients with osteoarthritis of the knee   "
46089|NCT02682355|"     Polymyxin B is already being used extensively in the USA and other parts of the world; its     use is likely to rapidly increase due to the greater burden of infections caused by MDR     Gram-negative bacteria and the growing awareness of the limitations inherent in the clinical     pharmacology of CMS/colistin. Cross resistance exists between the two polymyxins and thus     both must be dosed optimally; but the recently generated scientifically-based dosage regimens     for CMS/colistin cannot be extrapolated to polymyxin B. It is essential that an adequately     powered study is conducted to define the clinical PK/PD/TD relationships of polymyxin B and     identify, using next-generation proteomics, biomarkers for early detection of kidney injury.     This will allow the development of scientifically-based dosage regimens for various     categories of patients and an adaptive feedback control clinical tool for optimized dosing of     polymyxin B in future individual patients.   "
46090|NCT02682342|"     In this study, the investigators will test the hypothesis that acute in vivo exposure to     hyperglycemia increases mitochondrial network fragmentation and mitochondrial reactive oxygen     species production (ROS) production in human arterial endothelial cells.   "
46091|NCT02682329|"     To determine the effectiveness of combining different concentrations of hydrogen peroxide and     carbamide used during tooth bleaching.   "
46079|NCT02682485|"     Rationale: The surgical complication of intestinal anastomotic leak remains a clear and     present danger to patients despite advances in surgical technique and ever more powerful     antibiotics. No surgeon is immune from this complication and leak rates have not changed in     decades. The consequences of a leak (peritonitis, sepsis, death) can be so severe that in the     case of rectal cancer, diverting ileostomies are routinely performed to divert the fecal     stream away from the healing anastomosis. We have recently discovered that certain intestinal     bacteria, with the capacity to express collagenase and cleave MMP9 (Matrix metallopeptidase     9) to its active collagen degrading form, play a key and causative role in anastomotic leak.     These bacteria often escape elimination due to the failure of current antibiotic regimens and     their delivery methods to remain functionally durable at anastomotic tissue sites.      Purpose: This phase II clinical trial will track, in real time, the process of anastomotic     healing and its associated microbiome by performing serial endoscopic surveillance (SES)     following rectal cancer resection. By capturing anastomotic images and the associated     microbial and inflammatory mediators from anastomotic fluids via SES performed at three time     points following rectal cancer resection, we will correlate healing to microbial composition     and inflammatory mediator status. Patients will be randomized and, at each time point, will     receive lavage of their anastomosis with either saline or a triple antibiotic solution     (ciprofloxacin, metronidazole, neomycin). An anastomotic healing score captured during SES     will be compared between the two treatment arms and correlated to microbial and inflammatory     mediator analyses of fluid samples to determine how intestinal microbes influence the process     of anastomotic healing.   "
46080|NCT02682472|"     Admission into a care home for people with dementia has been linked with both positive and     negative psychological outcomes for both the resident and their carers. Whilst some people     with dementia adjust quickly, many never adjust at all or adjustment is complex and linked to     cognitive and behavioural decline (Wilson et al, 2007). Therefore, support for healthy     adjustment is needed.      Recent research (Aminzadeh et al., 2013; Sury, Burns and Brodaty, 2013, Sussman and Dupuis,     2013) has identified factors that influence different relocation outcomes and prevent adverse     reactions. There are currently no interventions that support successful adjustment by     emphasising the positive factors found to influence relocation outcomes while mitigating the     effects of negative influences and addressing any missed pre-admission procedures, reported     in the literature.      The current project seeks to design an intervention that predominantly builds on the work of     Sury et al (2013) and focuses on promoting healthy adjustment through an enhanced best     practice based admission process.      The intervention will be developed through systematic review of the literature and     consultation with professional experts, service users, care home staff and carers. The     current study will serve as a feasibility (pilot) study and test the acceptability of the     intervention design, examine recruitment and dropout and establish sample size for future,     larger studies. It also aims to examine whether the intervention indicates an improvement in     residents' quality of life, mood, overall adjustment and carer satisfaction with care.      All participants will receive a subset of the same intervention, specifically tailored to     their needs and with elements delivered by staff, carer or psychologist. Staff and     researchers will assess the improvement indicators mentioned above using relevant     psychometric measures at baseline, post intervention completion and at one-month follow up.     Indirect measures (interviews and staff field notes) will also be used to indicate     intervention fidelity and feasibility.   "
46081|NCT02682459|"     The natural course of extracapillary glomerulonephritis is severe leading to End-Stage Renal     Disease (ESRD) or death in most cases. Despite immunosuppressive treatment, long-term renal     outcome remains poor since active crescents usually progress to fibrotic scars with     glomerular occlusion and disruption.In experimental models Angiotensin Converting Enzyme     (ACE)-inhibitor therapy targeting the over-expression of angiotensin type 1 (AT1) receptors,     that are responsible for dysregulated proliferation of parietal cell progenitors, blocks the     formation of crescents and their fibrotic evolution. Should these drugs have similar effects     in humans, ACE-inhibitor therapy on top of standard immunosuppression might be instrumental     to prevent ESRD and promote renal function recovery in clinical practice.   "
46082|NCT02682446|"     After endoscopic resection of early gastric cancer (EGC), there remained concerned about the     development of the metachronous gastric neoplasm (MGN). The aim of this study was to evaluate     the role of H. pylori eradication for reducing MGN after ESD and the efficacy of serum     pepsinogen (PG) for predicting development of MGN after endoscopic submucosal dissection     (ESD) for EGC and to evaluate other risk factors for the incidence of MGN. The investigators     enrolled the participants who were tested serum PG I and II at the time of ESD for EGC, from     January 2007 to May 2013 in single tertiary center, retrospectively. The baseline     characteristics of the participants, H. pylori status, and serum pepsinogen were analyzed for     the development of the MGN.   "
46123|NCT02681913|"     Myocardial protection is a major issue in cardiac surgery, since inadequate protection     increases the risk of postoperative cardiac dysfunction. The main principle of myocardial     protection in cardiac surgery is to preserve myocardial function by preventing ischemia with     blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood     cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is     already used as standard care as an initial cardioplegic bolus in minimally invasive port     access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia,     has an added value remains unclear. Therefore the investigators would like to investigate the     effect of the addition of adenosine to standard intermittent warm blood cardioplegia in     patients scheduled for minimally invasive, port access operations (mitral valve surgery).      Half of the participants will receive standard intermittent warm blood cardioplegia, while     the other half will receive intermittent warm blood cardioplegia enriched with adenosine.   "
46083|NCT02682433|"     Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional     problems of the female reproductive system. Many articles examine the efficacy of diagnostic     hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most     of the articles are from the last decade, but the subject has been laid aside in the recent     years. Antonio Simone Lagana and his group have found that there is 100% correlation in     uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78%     correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his     group have found that there is a significant advantage to three-dimensional sonohysterography     over two-dimensional in the diagnosis of uterine cavity diseases. No significant difference     was observed, and 97% correlation was found, comparing three-dimensional sonar and     hysteroscopy. Work rationale is that there is a reason to reconsider the status of the     diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement     in resolution and three dimensional technologies.   "
46084|NCT02682420|"     Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create     an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for     hemodialysis.   "
46085|NCT02682407|"     The purpose of this study is to evaluate the safety and tolerability of OMS721 in subjects     with IgA Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and C3     Glomerulopathy (C3G), including Dense Deposit Disease. The study will also evaluate     Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and     neutralizing antibodies (Nab).   "
46086|NCT02682394|"     Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic     Steatosis in Patients with Pancreatic Cancer   "
46087|NCT02682381|"     Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose     of this study is to evaluate the safety and efficacy of teduglutide in children up to the age     of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to     receive the study drug or to participate in a standard-of-care arm. All participants who     complete the study may be eligible to receive the study drug in a long-term extension study.   "
46088|NCT02682368|"     Both acute gallbladder pathology and diverticular disease are common conditions met in     emergency departments in the western world and comprise the bulk of admissions throughout     general surgical calls. On the other hand both entities need imagistic confirmation and     description to tailor further management, which may be not readily available at the moment of     patient's presentation in A&E's doorstep or after referral to the on call general surgeon.     These delays may lose the window of opportunity for emergency surgery or prolong unnecessary     admission for a patient with known condition which may need just a fast exclusion of a more     advanced stage and then be further treated conservatively or even discharged.      The increased length of stay, as investigators know and expect is rising the costs of     healthcare and this is a very delicate subject in nowadays medical practice. Investigators     think that USS performed at the bedside will help in decreasing the length of stay,     especially for weekend admissions when radiology is not readily available.      Ultrasound scanning (USS) has become very popular over the last half century and the     equipment has become more compact, of a higher quality and less expensive, which has     facilitated the growth of point-of-care ultrasonography — that is, USS performed and     interpreted by the clinician at the bedside. The concept of an 'ultrasound stethoscope' is     rapidly moving from theory to reality.      Since 1993 surgeon-performed US came to the attention at 79th Annual Clinical Congress of the     American College of Surgeons. Nowadays USS was extended successfully to other acute settings,     and in several USA residency programs and several EU countries, bed side imaging is included     in the training curriculum or as stand alone competence for non radiological medical     practitioners.      Alas it is still not the norm across EU or the entire USA despite studies that proved its     usefulness.      As an example, currently in Ireland surgeon performed US is not a popular skill. The present     paper proposes to address this issue at a larger scale than present studies, which tend to be     confined on a limited number of patients and hospitals and different approaches. Currently,     the European Society for Trauma & Emergency Surgery® provides modular USS courses that imbue     surgeons with necessary skills to perform bedside US for conditions like trauma (FAST scan),     acute cholecystitis. Also this paper aims to leap forward, for the more skilled     ultrasonographers in diagnosing and classifying diverticular disease.      The paper will be divided in two parts, the general part (with an extensive literature review     and basic science and gestures for US performing) while the second part will be the original     research.      The closing remark is that by learning and doing these procedures the surgeon performing USS     doesn't undermine his/her radiologist colleague's authority and skill. The big picture is     that some basic tasks are transferrable and if used in an appropriate and methodical manner     the final common goal - the benefit of the patient - is readily achieved.   "
46100|NCT02682212|"     The main objective is to investigate effects of perineal trauma at birth on women´s health     and whether early physiotherapy improves pelvic floor strength. This will be achieved by an     acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women     with symptomes of urinary incontinence according to the questionnaire will be offered     participation in a single-blinded randomized intervention study to compare outcome after     targeted physiotherapy with conventional advice and support. Intervention encompasses weekly     pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information     collected before and after intervention and 12 months postpartum in both groups.      Pelvic floor problems after delivery are common and often persistent, including urinary/fecal     incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and     handicap women in multiple ways, physically, psychologically and socially. More knowledge of     whether interventions and guidelines in this field can improve health and QoL is required.   "
46101|NCT02682199|"     The goal of this prospective observational study is to investigate whether whole brain     radiation leads to measurable xerostomia from parotid gland toxicity.   "
46102|NCT02682186|"     Breast augmentation is among the most popular surgical procedures performed in the world with     approximately 1,773,584 performed in 2013. This surgical intervention generates important     pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is     proposed to the patients .The pectoral nerve block is an innovative technique of locoregional     anesthesia that has already been successfully used in breast surgery. Its realization is     fast, simple, and it would be superior compared with a paravertebral block within the     framework of mastectomy. The interest of this technique has never been assessed in esthetic     breast surgery. The aim of this study is to evaluate the analgesic efficacy of the     association of  Pecs blocks 1 and 2  on pain intensity after breast augmentation surgery.   "
46103|NCT02682173|"     Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in     the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat     distribution in the liver has so far been studied with liver biopsies and single voxel MR     techniques. With this trial investigators present a new, whole organ MR-quantification of     liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.   "
46104|NCT02682160|"     The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily     protein intake in obese patients who underwent a bariatric surgery (in the 3 months following     surgery).   "
46105|NCT02682147|"     This study will use dual energy x-ray computed tomography (DECT) to evaluate the relationship     between heterogeneous perfusion, hypoxia (low oxygen in inspired gas) and induction of     pulmonary vascular dilatation to characterize emphysema susceptibility in a normal smoking     population. The investigators will correlate DECT measures of perfusion with lung injury     measured by single photon emission computed tomography (SPECT). The investigators will study     the effect of pulmonary arterial vasodilation to see if it eliminates indices of persistent     lung injury in smokers that are susceptible to emphysema   "
46106|NCT02682134|"     The aim of this interventional study is to find out the incidence of sore throat among     intubated patients in Jordan university hospital and to find out which is preventive and     effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as     lubricant versus dexamethasone 8 mg intravenously or both.   "
46124|NCT02681900|"     This study tests the effects of a self-affirmation manipulation on (i) acceptance of a health     message detailing the risks of alcohol consumption, (ii) engagement with the health message     and (iii) alcohol consumption at 7-day follow-up. Half of the participants complete a     self-affirmation manipulation, where they reflect on their most important values, whereas the     other half complete a control equivalent, where they reflect on their least important values.     Immediately post-intervention, all participants then receive information about the risks of     alcohol consumption and complete measures of message acceptance and engagement with the     materials. Seven days after intervention, participants self-report their alcohol consumption     in the previous 7 days.   "
46107|NCT02682121|"     Diabetes mellitus (DM) imposes an approximate 2-fold increased risk of atherothrombosis.     Patients with type 2 DM have a 2- to 4-fold increase in the risk of coronary artery disease     (CAD) and atherothrombotic complications. Current evidence indicates that altered platelet     function and reactivity are key determinants of arterial and venous thrombosis in metabolic     syndromes. In addition, venous thrombosis and pulmonary embolism are associated with     increased body mass index, a common feature of type 2 DM and the metabolic syndrome. Altered     platelet behavior, function, and phenotype may be critical factors in these thrombotic     complications as well. The mechanisms that lead to altered phenotype and function of     platelets in DM, and that underlie heightened contributions of platelets to thrombotic     complications in type 2 DM, are nevertheless incompletely understood. In this project, the     investigators will prospectively determine if clinical intervention with metformin--a     commonly-used therapeutic agent that reduces blood glucose, promotes weight loss, and     improves lipid profiles--reverses platelet reprogramming and hyperreactivity in obese     subjects with impaired fasting glucose and thus, at-risk for type 2 DM.      In addition to metformin, all participants will be given lifestyle modification (LSM)     education on diet and physical activity, followed by guidance on how to adhere to the LSM,     depending on random assignment to intervention group (education only (n=26) vs.     implementation intentions alone (n=27) vs. implementation intentions with partner (n=27)).     The LSM coaching for different intervention groups will allow the investigators to test     whether there are more effective ways for adherence than others. Participants in these three     LSM intervention groups will be further randomized to either Metformin (n=40) or Placebo     (n=40), such that participants in the three LSM groups will be randomly and evenly     distributed across the two study medication groups.   "
46108|NCT02682108|"     Several noninvasive radiological techniques have been investigated for the diagnosis of liver     fibrosis and cirrhosis among patients with chronic infection with hepatitis B virus or     hepatitis C virus. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a particularly     appealing method for the diagnosis of liver fibrosis. The aims of this study are to evaluate     the accuracy of DW-MRI in patients with chronic viral hepatitis for determining the stage of     liver fibrosis.   "
46109|NCT02682095|"     The purpose of the study is to get an understanding about what problems patients with     hypertension are facing, how they manage these challenges, how they feel and what     requirements they believe are important to have in their treatment. These factors will later     act as a foundation and incentive for designing an intervention that may result in more     patients achieving blood pressure control with maintained quality of life.   "
46110|NCT02682082|"     The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with     Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable     pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea,     excessive sedation, constipation).   "
46111|NCT02682069|"     This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest     Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are     receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an     adjunctive tool in the assessment of the wound and will be used to guide the targeted     sampling of a wound (punch biopsy method).   "
46112|NCT02682056|"     This study will compare three glucose measurement techniques among diabetic children and     adolescents. The study seeks to determine if a hydrogel microneedle patch, versus a lancet or     intravenous catheter, would be a preferable option for monitoring glucose levels among the     diabetic pediatric population.   "
46114|NCT02682030|"     The investigator is examining the use of one airway clearance medical device compared to the     use of two airway clearance medical devices together in patients with amyotrophic lateral     sclerosis (ALS). More specifically, the investigator wants to know how effective the use of     either a mechanical High Frequency Chest Compression (HFCC) device is on its own or the use     of both a mechanical High Frequency Chest Compression (HFCC) device and Cough Assist together     to maintain a healthy airway and clear secretions.      The first device is a passive form of mechanical High Frequency Chest Compression (HFCC),     which was designed to help clear the airway of mucus and other secretions through mechanical     knocking of the chest area. The second device, called a Cough Assist, aids patients to clear     mucus and secretions that they would otherwise be unable to clear with coughing. This study     will enroll up to 20 people in total at CSMC.   "
46115|NCT02682017|"     Red meat makes a significant contribution to the human diet. The most widely consumed meat     globally is pork which accounts for 36% of overall meat intake with beef and poultry     contributing 22% and 35%, respectively. Pork meat provides a range of important nutrients     including protein, zinc, B-vitamins and a range of important minerals however there is     accumulating evidence to suggest that consuming red meat and processed meat increases the     risk of cardiovascular disease (CVD) and colon cancer. Despite these reports of a negative     impact on health, global pork consumption continues to increase and there are increasing     efforts to improve the nutritional profile of pork meat through the development of novel     porcine feed regimens. The manipulation of pig feed to produce 'healthier' meat and meat     products offers a feasible approach to reduce the risk of preventable disease. Furthermore,     recent projections of an increased global demand for pork and poultry, particularly in China,     have highlighted the increasing strain that will be placed on the supply of grains and the     need to find alternative and sustainable feed ingredients. Macroalgae is emerging as a     potential sustainable source of novel bioactive ingredients for the animal feed industry with     some species known to be a good source of protein, minerals, polyunsaturated fatty acids and     a range of fibre components including fucoidan and laminarin.      The polysaccharides, laminarin and fucoidan, which are found in abundance in brown seaweed,     are gaining increasing attention as a potential bioactive feed ingredients with putative     antioxidant, anti-inflammatory and immunomodulatory activities. Incorporation of a     laminarin/fucioidan mix (LAM/FUC) into the porcine diet was shown to result in lower levels     of lipid oxidation in fresh pork steaks. Numerous studies to date have also investigated the     health promoting effects of LAM/FUC through modulation of the porcine gut microbiota which     was shown to enhance inflammatory cytokine expression in response to pathogen recognition and     also to increase piglet performance post weaning.      The uptake and fate of fucoidan in humans remains unknown albeit after consumption, unaltered     fucoidan has been detected in human plasma after ingestion suggesting at least partial     bioavailability of this compound. A study by Moroney et al. (2015) using an in vitro     bioavailability Caco-2 model provided indications that fucoidan was bioavailable and that it     may have potent antioxidant potential.      The primary aim of this randomised parallel placebo controlled human intervention trial was     to investigate if consuming pork meat from pigs supplemented with a LAM/FUC mix, in addition     to their normal diet, would impact on blood oxidant and inflammatory status of healthy     adults. The secondary aim was to determine the effect of consuming LAM/FUC fed pork meat on     lymphocyte DNA damage, lipid status and immune function in healthy adults.   "
46116|NCT02682004|"     After vaginal delivery, all of the participants will evaluate by using Edinburg depression     scale and venous blood sample will obtain. Postpartum depression will consider the result of     scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin     level will compare between depressed and nondepressed women.   "
46117|NCT02681991|"     Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic     renal failure.      120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).      Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum     indoxyl sulfate will be evaluated.   "
46118|NCT02681978|"     This study evaluates the effect of ivabradine on endothelial function in patients with     coronary artery disease (CAD) after complete revascularization with percutaneous coronary     angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive     ivabradine 5 mg twice daily or to continue with standard medical therapy.   "
46119|NCT02681965|"     Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC     breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical     activity, and 4)quality of life in women randomized to receive the modified LEAN intervention     compared to women randomized to wait-list control (i.e., the wait-list control will receive     the modified LEAN intervention after completing the 6-month study).   "
46120|NCT02681952|"     A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical     Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and     Kremezin in Pre-dialysis Patients With Chronic Renal Failure   "
46121|NCT02681939|"     This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and     biochemical parameters in young overweight and obese subjects. Thirty overweight/obese     volunteers will be divided into two groups. The first group will receive no intervention. The     second group will be supplemented with one capsule of Tulsi orally every morning and evening     in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated     before and after the intervention.   "
46122|NCT02681926|"     Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. A     novel technology was recently developed to allow an automatic points annotation when indirect     parameters of lesion formation reach predefined target values.      The aim of the study was to evaluate, in a prospective and multicenter study, the safety,     efficiency and PVI effectiveness of a new ablation tracking tool (VISITAG; Biosense Webster)     during paroxysmal AF ablation using a contact force sensing catheter.   "
46133|NCT02681783|"     The presence of Pigment Epithelial Detachments (PEDs) in neovascular Age-related Macular     Degeneration (nAMD), Central serous chorioretinopathy (CSR) and idiopathic Poplypoidal     Choroidal Vasculopathy (iPCV) can present a diagnostic challenge in the elderly population;     despite detailed diagnostic testing to differentiate these three conditions, misdiagnosis and     mistreatment still occurs. One potential way of differentiating these three conditions might     be to compare cytokine profiles in nAMD versus CSR versus iPCV. This information may be     useful in creating a diagnostic aqueous cytokine and hormone profile to differentiate between     nAMD, CSR and iPCV.      The primary goal of this study is to compare baseline aqueous cytokine and cortisol levels     between nAMD, CSR, and iPCV patients and age-matched cataract controls. The secondary     objective is to assess intra-group changes in visual and anatomical outcomes in nAMD, CSR and     iPCV patients with PED treated with aflibercept and correlate these changes to baseline     cytokines. We will not be comparing visual and anatomical changes between groups after     treatment in this study.   "
46169|NCT02681315|"     This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6     liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates     of extubation failure in mechanically ventilated preterm infants.   "
46125|NCT02681887|"     In a 12 week double-blind, placebo-controlled randomized trial, 120 subjects with obesity     (BMI≥30 kg/m2) and pre-diabetes (HbA1c, 5.7-6.4%) will be randomly assigned 1:1 to receive     either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour     before bed. The investigators will assess melatonin's effect on insulin sensitivity by     performing a hyperinsulinemic euglycemic glucose clamp and β-islet cell function measured     using a hyperglycemic clamp, as a primary endpoint. The investigator will also evaluating     melatonin supplementation's effect on mean 24-hour ambulatory blood pressure, nocturnal blood     pressure, and potential intermediates including endothelial function using brachial     ultrasound, catecholamine production using 24-hour epinephrine and norepinephrine excretion,     and renin-angiotensin system activation using measurements of plasma renin activity,     angiotensin II, and urine aldosterone excretion. The final endpoint will be to evaluate     melatonin supplementation's effect on cellular cytokine and CC family chemokine expression as     well as high sensitivity C-reactive protein, IL-6, and TNF-α.      There will be a 24 week cohort phase as an extension of the trial. This will be an open-label     prospective study of 50 subjects recruited from the trial who will take 2 mg of     controlled-release melatonin nightly for 24 weeks after completion of the 12-week trial. At     the end of the cohort-phase (36 weeks after entry in the trial), the investigators will again     assess the extended use of melatonin supplementation on 24-hour BP, and glycemic control     (HbA1, fasting glucose).   "
46126|NCT02681874|"     Many behavioral interventions designed to improve dietary patterns for ethnic and     racial/minority preschoolers have produced modest outcomes. A limitation of these     interventions include a failure to address key factors associated with dietary patterns for     these children, such as parental stress levels. Therefore, the identification of intervention     models that target these factors and are effective, acceptable, and feasible among parents of     young minority children is important.      Subjects will be asked to take part in this study because they are the parents of a child     that receives care at a Texas Children's Pediatrics (TCP) clinic where the study is being     done and their child's body mass index has been at or above the 85th percentile.      The purpose of this pilot study is to assess the ease and acceptance of providing an     intervention for parents of children ages 2-5 years in the pediatric primary care clinic. The     purpose is to also assess how well the intervention works in improving the child's dietary     patterns.   "
46127|NCT02681861|"     The purpose of this study is to evaluate the safety and tolerability of single ascending     intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and     female subjects.      This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous doses     and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered     intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF);     explore a potential gender difference in safety, tolerability and pk of single intravenous     dose and single sc doses administrations of ASP6294 as well as determine the maximum     tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294.      Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc.   "
46128|NCT02681848|"     Introduction: Smoking is a major avoidable cause of ill-health and premature death.     Treatments that help patients successfully quit smoking have an important effect on health     and life expectancy. Varenicline is a medication that can help smokers successfully quit     smoking. However, there are concerns that it may cause adverse effects, such as increase in     the occurrence of depression, self-harm and suicide and cardiovascular disease. In this study     the investigators aim to examine the effects of varenicline versus other smoking cessation     pharmacotherapies on smoking cessation, health service use, all-cause and cause-specific     mortality and physical and mental health conditions.      Methods: In this project the investigators will investigate the effects of varenicline     compared to nicotine replacement therapies on: (1) long-term smoking cessation and whether     these effects differ by area level deprivation; and (2) the following clinically-important     outcomes: rate of general practice and hospital attendance; all-cause mortality and death due     to diseases of the respiratory system and cardiovascular disease; and a primary care     diagnosis of respiratory illness, myocardial infarction or depression and anxiety. The study     is based on a cohort of patients prescribed these smoking cessation medications from the     Clinical Practice Research Datalink (CPRD). The investigators will use three methods to     overcome confounding: multivariable adjusted Cox regression, propensity score matched Cox     regression, and instrumental variable regression. The total expected sample size for analysis     will be at least 180 000. Follow-up will end with the earliest of either an 'event' or     censoring due to the end of registration or death.      Ethics and dissemination: Ethics approval was not required for this study. This project has     been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). The     investigators will disseminate the findings via publications in international peer-reviewed     journals and presentations at international conferences.   "
46129|NCT02681835|"     We therefore designed this randomized crossover study to compare C-MAC with Macintosh     laryngoscope in emergency intubation performed by paramedics according to three different     intubator positions.   "
46130|NCT02681822|"     To study the impact of genetic and environmental factors on high-level cognition associated     neural circuits among healthy young Chinese Han subjects.   "
46131|NCT02681809|"     The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal     injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe     non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment     (PVD) in order to reduce the risk of disease progression to proliferative diabetic     retinopathy (PDR).   "
46134|NCT02681770|"     Following solid organ transplantation, adherence to treatment regime (especially with regard     to a reliable intake of immunosuppressant medication) is crucial for transplant survival, and     has an impact on the patients' health and morbidity. Approximately 35 % of graft rejection or     failure cases in kidney transplant patients are due to insufficient levels of adherence or     non-adherence to immunosuppressant medication. Adherence is influenced by both individual and     interpersonal aspects in complex interaction.      This study aims at investigating individual and dyadic functioning of both patients and their     spouses following kidney transplantation. Outcome measures of interest are patient's level of     adherence and both patient and spouse's subjective quality of life.   "
46140|NCT02681692|"     Colonoscopy is widely considered as the main choice for patients with suspected colorectal     disease,and for screening those at high risk of colorectal cancer. However， colonoscope     examination,especially those unsedated ones for screening,may bring much pain to     patients,even induce some severe complications such as perforation.Considering the increasing     need of colonoscopy examination for screening purpose,it has been a problem deserving of     further study that how to reduce pain and ensure safety during the procedure.Some studies     suggest that use of Magnetic endoscopic imaging(MEI) during colonoscopy has the potential to     ease patient discomfort and reduce complications.Theoretically,the MEI could accurately     depict the position of the scope in three dimensions and help avoid forcefully feeding the     colonoscope through loops of vulnerable bowel,thus alleviating patient pain and promoting     procedure safety.However,the problem whether MEI system could help reduce patient pain during     procedure effectively，especially in inexperienced colonoscopists，still remains controversial     for researchers,and no study has been designed to test the hypothesis that MEI may help     decrease the risk of some complications,such as colon perforation.In this study we aim to     evaluate the he efficacy of magnetic scope navigation on patient pain during unsedated     colonoscopy；In addition，we try to construct a simple colon force measurement device ,and by     using this device to observe the variation of force exerted on colon loop ,we expect to find     the potential mechanism of pain-alleviation and explore the possible effect of complication     reduction during colonoscopy under the influence of MEI system.   "
46141|NCT02681679|"     Since a new generation of femtosecond lasers became available for cataract surgery in 2009,     the use of this image-guided system has provided several benefits, including a reduction in     phacoemulsification energy by prefragmentation of the crystalline lens, and the potential     advantages of more precise corneal incisions and capsulotomy formation. However, as with any     new surgical technique, femtosecond laser cataract surgery also has potential complications.     Intraoperative miosis is one of the most common intraoperative complications of femtosecond     laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%.8     Significant pupillary constriction necessitates the removal of the anterior capsule flap,     fragmented nucleus and remaining cortex, which is potentially associated with a higher rate     of surgery-related complications.   "
46143|NCT02681653|"     Sepsis is a common, expensive, frequently fatal and highly complex inflammatory syndrome     wherein multiple cellular and humoral pathways are involved. Since it's a multifactorial     syndrome merely blocking one of the various inflammatory pathways may not suffice to provide     effective treatment and this may partly explain why most of the adjunctive therapies     developed for severe sepsis have yielded disappointing results in rigorous clinical trials.     Statins have varied pleiotropic effects on the inflammatory mediators and there addition to     the current adjuvant therapies in septic shock may help in reduction of mortality. The     present trial aims to study survival benefit and changes in bio-marker levels in septic     shock.      Adult patients (>=18 years) in septic shock and admitted to ICU will be included in the     study. Patients will be randomized as per computer generated random number into the Drug     (Atorvastatin, 40 mg) or matched placebo group. Drug or placebo will be given to selected     patient via nasogastric tube for 7 days. Bio markers (Il-6, TNF-alpha) estimated during the     trial week (Days 1, 4, and 7). All clinical and study personnel and patients remained blinded     to the study group assignment throughout the trial.   "
46144|NCT02681640|"     The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node     metastases in breast cancer.   "
46145|NCT02681627|"     There is increasing amount of evidence which suggests that miscarriage is related to a     primary endometrial problem. Recent cochrane meta-analysis (March 2015) has proven that     endometrial scratch improves live birth in women who underwent IVF.      The aim of the study is to find out if scratch of the endometrium prevents recurrent     miscarriage.   "
46146|NCT02681614|"     This clinical research study tests the Uronav system. Patients with prostate cancer will be     asked to take part in this study.      Uronav system is an investigational device that is used on this study to help place markers     in the patient. These are called fiducial markers and they are placed in the patient to help     plan radiation treatment. Radiation therapy treatment will be planned by the treating     physician and will not be experimental or part of this research study.      This study will also test the similarities and differences of biopsy tissue structures and     the findings from the intraprostatic MRI (internally guided MRI).   "
46147|NCT02681601|"     There are few well-designed studies evaluating the effect of nutrition support in patients     with cancer cachexia. The aim of this study is to examine the effect of dietary prescription     with and without nutrition supplementation in patients with unresectable pancreatic cancer on     body weight, body composition, total calorie intake, quality of life and blood inflammatory     markers.   "
46148|NCT02681588|"     This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand     the potential independent effect of maternal obesity on fetal growth, investigators designed     a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI < 25 kg/m2) or     obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was     screened and treated throughout pregnancy.   "
46149|NCT02681575|"     The purpose of this study is to examine the initial efficacy of a psycho-social,     metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit     Hyperactivity Disorder (ADHD).      It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate     improvements in measures of executive functioning, occupational performance and quality of     life.   "
46163|NCT02681393|"     It is essential that individuals living with stroke engage in physical activity to improve     cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This     objective of this study is to examine the effectiveness of an educational brochure that     promotes exercise in people with stroke, combined with a motivational telephone support, on     maintaining physical activity. Fifty participants with stroke will be enrolled. This study     will provide insight into implementing effective tools that are designed to help individuals     with stroke maintain physically active behaviours in the long-term.   "
46150|NCT02681562|"     Treatment selection for breast cancer is still largely empiric and guided by large randomized     clinical trials on populations of patients. This approach is inadequate for the selection of     individualized chemotherapy regimens. Estimates of benefits for individuals are     extrapolations from the effects seen in these large trials, and do not necessarily apply to     individual patients. The revolution in genomics promises to transform oncology care. By     better defining cancer subtypes, a better understanding of breast cancer biology should help     to guide treatment.      The up-front phase we have decide to adopt play a pivotal role as it is useful for testing a     targeted therapeutic drug such as olaparib wich also requires development of new biomarkers     which may be useful for future studies. With this approach it could be possible to     demonstrate drug target or biomarker effect in clinical setting and models the relationship     between the pharmacodynamics and the pharmacokinetics. Additional benefits of this approach     include the following:        -  It could facilitate rational drug selection, identify therapeutic failures early, and          compress timelines for anticancer drug development.        -  It could provide initial rationale and guiding principles for further drug development          based on studies in humans (rather than xenografts, where tissues of one species are          transplanted to another species).        -  As it focuses on extensively characterizing how a drug works and whether it hits its          intended target (including molecular imaging studies) in a limited number of patients it          could yield results that would optimally inform and expedite the subsequent development          of molecularly-targeted agents   "
46151|NCT02681549|"     The purpose of this phase 2 trial is to study the activity of pembrolizumab in combination     with bevacizumab in patients with untreated brain metastases from melanoma or NSCLC to     determine activity and safety of the drug combination. Furthermore, in patients who undergo     resection of biopsy of a brain metastasis, we will evaluate biomarkers predictive of     treatment benefit, and will also conduct correlative biomarker studies on extra-cerebral     specimens in all patients in whom a systemic biopsy is feasible or in archival tumor tissue     when available.      A total of 53 eligible patients will be enrolled on this trial (20 with melanoma and 33 with     NSCLC). Individual cohorts of the study can be stopped if insufficient activity is observed     in the first stage of that cohort. The study will accrue for approximately 24 months, and     will be open for approximately 12 additional months as patients on study are being followed.   "
46152|NCT02681536|"     The study is performed to compare the outcomes of two stimulation protocols, the minidose     long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.   "
46153|NCT02681523|"     A single centre, single arm phase II study of alternating eribulin and hormonal therapy in 12     patients with locally advanced or metastatic breast cancer who have received at least one     hormonal therapy and at least one chemotherapy in the metastatic setting.   "
46154|NCT02681510|"     This study will focus on enhancing future smoking cessation treatment effectiveness by     piloting a potentially more powerful combination of three FDA-approved pharmacotherapies:     varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment     (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design     of future studies that would use this combination treatment as a cessation tool within the     chronic care arsenal of treatments.   "
46155|NCT02681497|"     This study is a retrospective chart review study aiming to assess the characteristics and     health outcomes of patients with type 2 diabetes treated with canagliflozin when used in     addition to insulin therapy. Furthermore, the project aims to establish an EMR-based cohort     of patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin to allow for     future longitudinal studies that investigate outcomes over a longer follow-up period, and     whether canagliflozin (when used in addition to insulin therapy) has an impact on     diabetes-related healthcare costs.   "
46156|NCT02681484|"     Anthroposophic speech therapy (ATS) has been shown to positively influence heart rate     variability (HRV) and heart rate - respiration coordination in healthy volunteers. This study     was performed to learn more about such improvements and possible alteration in baroreflex     sensitivity (BRS) in hypertensive patients, which characteristically differ in those     regulatory parameters from normotensive patients   "
46157|NCT02681471|"     Aim of this prospective clinical study was to compare two different surgical techniques and     used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP)     syndrome undergoing TURP.      Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical     study. Patients were included one of two groups (Group Monopolar and Group Bipolar).   "
46158|NCT02681458|"     The purpose of this study was about survey of prevalence of fungal infections among drug     users referring to methadone wards of Hospitals in northeast region of Iran   "
46159|NCT02681445|"     The purpose of this pilot study is to evaluate the sensitivity and specificity of a     nanotube-based point-of-care breath-based tuberculosis screening test as compared to the     current standards of care including sputum microscopy, sputum culture, chest X-ray, and     GeneXpert (MTB/RIF).      The primary objective is to determine an initial estimate of the sensitivity and specificity     of a nano-tube based point-of-care test for the diagnosis and screening of active pulmonary     tuberculosis.      Secondary objectives include the collection of user data to test and further develop the     screening platform based on end-user feedback.   "
46160|NCT02681432|"     Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia     intraperitoneal chemotherapy with paclitaxel in ovarian cancer.   "
46161|NCT02681419|"     This study evaluates two different methods of controlling intraocular pressure in nonvalved     aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.   "
46162|NCT02681406|"     Investigators will recruit 280 alcohol dependent patients in treatment programs in the     Philadelphia area to test the efficacy and cost efficiency of a smartphone based application     for treating alcohol addiction (ACHESS) with telephone monitoring and counseling (TMAC).     Participation in the study lasts for 18 months with research visits at baseline, 3 months, 6     months, 9 months, 12 months, and 18 months. The intervention lasts 12 months.   "
46164|NCT02681380|"     Empathy is an important skill to learn for medical student. However, learning empathy remain     difficult. The investigators aim was to assess the efficacy of a specific training, Balint     like, on the empathy abilities of medical students in the 4th year. The investigators planned     a randomized controlled trial in 3 universities.   "
46170|NCT02681302|"     The goal of this study is to determine the safety and clinical effect of combined checkpoint     inhibition administered after autologous hematopoietic stem cell transplantation in each of     six clinical cohorts of high risk and recurrent disease. In addition to assessing the     incidence and severity of adverse events and rates of complete response and progression free     survival, investigators intend to monitor immune reconstitution, phenotype and TCR repertoire     throughout treatment and at the time of disease progression. Investigators will also analyze     the gut microbiome prior to conditioning, throughout treatment, post-transplant and at time     of relapse.   "
46171|NCT02681289|"     Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to     compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application     between preterm and term at-risk infants.   "
46172|NCT02681276|"     Aim: To compare the clinical antimicrobial and adverse effects of irrigation with Sodium     Hypochlorite (NaOCl) 0.5% versus NaOCl 3% during root canal treatment.      Methodology: Consecutive patients referred to a specialist clinic of endodontics are randomly     assigned to have the root canal treatment performed with a concomitant irrigation either with     a buffered 0.5 % NaOCl (Dakin's solution) or 3 % NaOCl. Teeth with vital or necrotic pulps     and retreatment cases were included. Root canal treatment procedures varied but followed the     routines of the Specialist Clinic of Endodontics, Public Dental Health, Gothenburg, Sweden.     Immediately before the root canal filling a microbial sample is taken from the operative     field and the root canal. The bacterial samples were processed at the laboratory as outlined     by Möller (1966). After each visit each patient was instructed to fill in a questionnaire and     assess his or her post-operative pain on a visual analogue scale (VAS), with endpoints 0= no     pain and 10= worst imaginable pain, for seven consecutive days. The Fischer's exact test     was used for statistical analyses of the differences in outcome between the groups.   "
46173|NCT02681263|"     The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI     requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing     Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study     will describe and support the use of high dose (6g/day) of temocillin which could be of     interest for the treatment urinary tract infection due to multi-resistant bacteria having     high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by     monitoring the adverse event and the incidence of eventual Clostridium difficile associated     infection.   "
46174|NCT02681250|"     A Randomized controlled Clinical trial including 96 patients in which aim is to investigate     the clinical outcome of dental implants in titanium-zirconium alloy compared to traditional     titan-4 implants. The hypothesis is set to no difference in the clinical outcome for the two     types of implants.   "
46175|NCT02681237|"     This is a proof of concept study (a study to initially assess the benefit a new drug     indication) of the combination of two investigational drugs cediranib and olaparib in     patients with ovarian cancer whose cancer worsened despite previously receiving a poly     (ADP-ribose) polymerase (PARP) inhibitor (such as olaparib).      The purpose of this study is to find out whether taking cediranib and olaparib at the same     time will be able to stop tumors from growing further or shrink it.      Cediranib works by blocking (inhibiting) several specific proteins in cancer cells called the     vascular endothelial growth factor (VEGF) receptors. These proteins are important in the     formation of blood vessels to the tumor. It is believed that many tumors survive because the     blood vessels on the tumors bring oxygen and nutrients to the cancer cells which enable them     to grow. If the formation of the blood vessels is blocked, the tumor cells may die.      Olaparib, works by blocking a protein called poly [adenosine diphosphate-ribose] polymerase     (PARP). PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA,     molecules that contain important instructions for the development of cells). Many cancers are     thought to develop from damaged DNA. By blocking PARP from fixing damaged DNA, the tumor     cells may die.      Adding cediranib to olaparib, and therefore blocking several different mechanisms for cancer     growth, may stop tumor growth.   "
46176|NCT02681224|"     A single site, double-blind, randomized, placebo-controlled, clinical study comparing the     difference between a novel healing gel and a placebo gel on post laser-resurfacing chests.   "
46177|NCT02681211|"     Patients with migraine headache will be offered the opportunity to participate in this     randomized study evaluating auricular acupuncture versus standard treatment for migraine     headaches for patients in the pediatric emergency department (ED).   "
46178|NCT02681198|"     The purpose of this study is to determine the pharmacokinetics, safety and tolerability of     lofexidine HCl in the presence of paroxetine in healthy adults.   "
46179|NCT02681185|"     The study's goal is to promote accessible and cost-effective diabetes care through electronic     means. Underserved populations including rural areas do not have diabetes specialists.     Previous study data has shown the effectiveness of Internet communication in lowering a     patient's Hemoglobin A1C, a measure of blood sugars, closer to the target number. The     investigators thus wish to test the effectiveness of diabetes care provided by virtual means,     including virtual consultations, online monitoring of blood sugars, diabetes education via     web-based videos, and support/advice provided through phone or email by an Endocrinologist.     The goal is to test if virtual care is a viable means to extend care for diabetes to     underserved populations.   "
46193|NCT02680990|"     This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of     Band Together, a strength-training and walking program (intervention arm) vs. education on     the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI)     malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant     therapy.   "
46180|NCT02681172|"     This phase 4 study will explore, in the context of the present French clinical practice, the     impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for     etiologic determination of the cognitive and functional impairment, but in whom:        1. lumbar puncture was not feasible for medical conditions        2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating          physicians        3. lumbar puncture was refused by the patient   "
46181|NCT02681159|"     Critical incidents in anesthesia is one of the most valuable methods to assess the safety of     anesthesia practice among different types of patients. Most of the studies in this regards     are retrospective with many drawbacks and pitfalls like absence of information in the records     of the patients.      In the investigators' study, the investigators will follow the critical incidents among     patients who underwent surgery under anesthesia whether regional or general over the next two     years from 2016 to 2018, by examining the patients records from the hospital database and     recording the events that occur to the patients.   "
46182|NCT02681146|"     A stepped-wedge cluster design will be used, with the duration of the trial being 50 weeks.     The 'stepped-wedge ' cluster randomised trial is a form of cross-over design with     unidirectional cross-over ( from control to experimental ) but with randomisation of when     each cluster undertakes this transition. In the stepped-wedge design, there is a staggered     roll-out of the intervention, where the time and hence the sequence of units (clusters) that     will start the intervention at each period is determined by random allocation.      The randomisation occurs before the start of the trial. All clusters start the trial in a     control phase with no intervention being delivered at any site, then sequentially cross over     from the control group to the intervention group, until all sites are receiving the     intervention. Outcomes are measured on the study participants in all clusters at every time     period, hence measurement of outcomes takes place at each step in the wedge; each cluster     provides data points in the control and intervention conditions allowing each site to act as     its own control.   "
46183|NCT02681133|"     The primary purpose is to evaluate the level of physical activity in patients with knee     osteoarthritis in a spa treatment and doing epidemiological study about this patient.   "
46184|NCT02681120|"     This is a pilot, non-randomized, single institution, observational study investigating the     effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer     in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Twelve     months after bariatric surgery, 50% of excess weight is generally expected. Eligible women at     elevated risk for breast cancer who are already planning to undergo bariatric surgery will be     consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and fasting blood     draw prior to bariatric surgery, approximately 14 days after bariatric surgery, and     approximately 1 year after bariatric surgery.      In parallel we will also be assessing 40 normal breast tissue specimens as well as blood     samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI,     elevated risk control group for our study. The KTB samples will be matched for general risk     of breast cancer (>20%), age, race and menopausal status.   "
46185|NCT02681107|"     This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which is     expected to be equally tolerated as standard whole breast irradiation (WBI) based on     radiobiologic modeling of the fibrosis response of normal tissues but be more convenient and     less costly than 3-6 weeks of standard WBI. 274 women will be treated. Rates of fibrosis and     cosmesis at 2 years will be compared to data already collected using standard WBI in the     Canadian RAPID trial.   "
46186|NCT02681094|"     The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg     co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or     dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin     monotherapy.   "
46187|NCT02681081|"     The purpose of the study is to identify non-invasive strategies that will optimize the     neurobiological environment and improve learning and memory in the treatment of chronic pain.     The overall aims of the current proposal are to determine if food restriction and/or glucose     administration in conjunction with a relaxation/guided imagery exercise will result in     neurophysiological changes and functional improvements compared to the relaxation/guided     imagery exercise alone.   "
46188|NCT02681068|"     The registry collects cases of patients received fecal microbiota transplantation (FMT) due     to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to     analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to     implement a standardization of FMT in German hospitals and improve patient outcome.     Therefore, a detailed description of completions of FMT are documented on our web-based     survey platform www.ClinicalSurveys.net.   "
46189|NCT02681055|"     This is a multi-center, proof-of-principle, open-label study designed to evaluate the     efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and     Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.   "
46190|NCT02681042|"     The study cohort will consist of up to 50 patients who are candidates for Left Atrial     Appendage (LAA) closure in whom oral anticoagulation is contraindicated.      Subjects evaluated for left atrial appendage closure will be screened for inclusion and     consented prior to their procedure. If the anatomy is favorable for placement of the Lariat®     device, the procedure will be performed at one of the participating centers. If anatomy is     not favorable, the patient will be excluded from the study and managed using best care     practices by his or her physician.   "
46191|NCT02681029|"     Recent improvements in cell culture systems have led to a shift in in vitro fertilization     (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer.     Blastocyst culture and transfer could theoretically provide better synchronization between     the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy     rates and implantation rate following transfer of thawed cleavage embryos and blastocysts     cultured from thawed cleavage embryos.   "
46192|NCT02681016|"     The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary     stent Calypso (Angioline, Russia) in comparison with everolimus-eluting coronary stent     Xience (Abbott Vascular, USA)   "
46575|NCT02675985|"     This study will investigate the safety and feasibility of early intensive physical therapy     for patients diagnosed with subarachnoid hemorrhage. Intervention will begin in the     neurological ICU and continue for 30 days or hospital discharge.   "
46194|NCT02680977|"     In low-income areas worldwide, most patients with Parkinson's disease (PD) cannot afford     long-term Levodopa therapy. A potential therapeutic option for them is the use of a legume     called Mucuna Pruriens var. Utilis (MP), which has seeds with a high levodopa content (5-6%)     and grows in all tropical areas of the world. MP powder is very cheap (total annual cost for     a PD patient: 10-15 US $). The aim of this study is to assess efficacy and tolerability of     acute and chronic use of MP compared to standard Levodopa therapy.      The primary objective of this study is to investigate efficacy of acute levodopa challenge     using MP in comparison to levodopa with a Dopa Decarboxylase Inhibitor (LD+DDCI) and without     (LD-DDCI) and placebo.      The secondary objectives are to investigate safety of acute intake of MP as well as efficacy     and safety of chronic intake of MP over a 8-week period in comparison to usual LD+DDCI home     therapy.   "
46196|NCT02680938|"     The third stage is the interval between delivery of the infant and delivery of the placenta.     This stage averages 10 minutes and is considered prolonged if it lasts longer than 30     minutes, placental separation occurs as a result of continued uterine contractions, continued     contractions control blood loss by compression of spiral arteries and also result in     migration of the placenta into the lower uterine segment and then through the cervix.      The intra-umbilical vein injection of 10 IU of oxytocin is recommended as a first line of     treatment for retained placenta. Despite this recommendation, the method has yet to make its     way into routine practice, probably because of the lack of a large substantive randomized     controlled trial, and lingering doubts over which uterotonic to use and at what dosage.      The purpose of this study is to evaluate the effect of intraumbilical vein injection of     oxytocin on reducing the duration of the third stage of labor and the need for manual     delivery of placenta, ,in addition to reduce blood loss during third and fourth stage of     labor and decrease incidence of rtained placenta in comparison with inraumblical injection of     normal saline.      This is a prospective randomized control trial conducted at Ain Shams University Maternity     Hospital. This study included 240 term pregnant women in labor admitted to the labor ward,     They were divided into Two groups :      Group (A):      The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the     most proximal site to the placenta after clamping and cutting of the umbilical cord.      Group (B):      The control group, 1 mL normal saline will be injected into the umbilical vein at the most     proximal site to the placenta after clamping and cutting of the umbilical cord.   "
46197|NCT02680925|"     The investigator will evaluate the influence of lung protective ventilation on postoperative     clinical outcome in pediatric patients. The hypothesis is that application of low tidal     volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure     (PEEP) would be more beneficial than conventional ventilation in children.   "
46198|NCT02680912|"     This is a two-armed randomised controlled pilot study that investigates the component     efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to     receive either warm needle acupuncture or needle acupuncture. Participants and acupuncturists     will be blinded to group allocation. The primary and secondary outcome measures are WOMAC and     SF36 respectively. Qualitative interviews will be used to gather information on the patients'     experiences and perceptions of the trial and the treatment provided.      It is hypothesised that warm needle acupuncture will lead to a greater reduction in clinical     signs and symptoms than needle acupuncture.   "
46199|NCT02680899|"     The study herein seeks to determine whether students undergoing InSciEd Out curriculum in     mental health and addiction (called My Mind, My Body) experience changes in their mental     health-related knowledge, attitudes, and help-seeking behavioral intentions. The research     group hypothesizes that students undergoing InSciEd Out mental health and addiction     curriculum will exhibit pre-post increases in mental health literacy, decreases in mental     health stigmatization, and increases in mental health help-seeking behavioral intentions.   "
46200|NCT02680886|"     The aim of this study is to show that the performance of Novosyn® Quick suture material is     comparable with other suture material used for skin closure. In order to show that, various     safety and efficacy parameters have been selected. The outcome regarding these parameters     will be evaluated by a quantitative summary of the available clinical data from the     literature.   "
46201|NCT02680873|"     the investigator modified the Sanator's operation by performing a loop rather than Roux-en-Y     bipartition reconstruction and the investigator are reporting the first clinical results of     the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation     therapeutic option for obese type 2 diabetes mellituspatients.   "
46202|NCT02680847|"     Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone     hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.   "
46203|NCT02680834|"     The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area     closure at 16 weeks with a dual action pneumatic compression device compared to multi-layer     bandaging.   "
46204|NCT02680821|"     Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate     ligament (ACL) revision will have a better rotational knee stability and therefore better     patient reported outcome measure (PROM) scores compared to patients, who have ACL revision     surgery without ALL reconstruction.   "
46205|NCT02680808|"     Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using     midazolam as a probe. Twenty healthy male subjects will participate   "
46206|NCT02680795|"     This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat     in patients with relapsed/refractory solid tumors or hematological malignancies who have     heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients     will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype   "
46207|NCT02680782|"     This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001     administered as 200 mg twice daily compared with 400 mg once daily.      This study will also assess the pharmacodynamic effects of X4P-001 administered as 200 mg     twice daily compared with 400 mg once daily on levels of circulating white blood cells (total     and by cell type).   "
46221|NCT02680600|"     Several population pharmacokinetic (PK) models for cefepime in critically ill patients have     been described, all indicating that variability in renal clearance is the main determinant of     observed variability in exposure. The main objective of this study was hence to determine     which renal marker best predicts cefepime clearance.   "
46208|NCT02680769|"     Magnesium (Mg) is involved in several pathways that could be affected in chronic obstructive     pulmonary diseases (COPDs), namely in the contractility and excitability of neuro-muscolar     endothelial cells and low-grade inflammation, a typical state of COPD. In this sense, several     randomized controlled trials (RCTs) confirmed a positive role of Mg in asthma since     long-period oral supplementation of Mg leads to a clinical and spirometric improvement.      Subjects with COPD seem to have a reduced bioavailability of Mg probably due to the use of     drugs that may increase Mg losses (e.g. beta-agonists and cortisones), to a reduced dietary     Mg intake, and heavy smoking. A recent study showed that the administration of endovenous or     aerosol Mg sulphate with beta-agonists acutely improve maximum expiratory flow during COPD     relapses as well as the prolonged treatment with endovenous sulphate Mg led to a reduction in     pulmonary hyperinflation and increase in muscles involved in respiration, with a consequent     clinical and instrumental improvement.      These evidences suggest that a chronic supplementation with Mg could improve COPD in clinical     and instrumental parameters, but, at the best of our knowledge, no study was available in     this sense.   "
46210|NCT02680743|"     Objective:      Congenital cytomegalovirus (cCMV) is the most common non-genetic cause of pediatric     sensorineural hearing loss (SNHL) and an important cause of neurodevelopmental delay. Infants     with cCMV can be symptomatic, asymptomatic, or asymptomatic except for hearing loss.     Symptomatic infants may be more readily identified and quickly referred for intervention     because they may present with classic common clinical findings, but the majority of infants     (85-90%) with cCMV are asymptomatic at birth and do not have the classic clinical,     laboratory, or radiologic findings and therefore often have delayed identification and     intervention. Often, these otherwise asymptomatic infants with cCMV may have early congenital     hearing loss and therefore fail the newborn hearing screen but because they are not     specifically identified as having cCMV there is a delay in seeking further audiology exam and     treatment of the CMV infection.      The overall objective of this proposed research is to investigate how testing newborns for     congenital cytomegalovirus infection (cCMV) after a failed newborn hearing screens can     improve early identification of cCMV infection and therefore reduce the delay in referral of     the newborn to appropriate specialists for intervention.      Eligibility Criteria:      Eligible participants will include newborns in the NBN or NICU who are less than 14 days of     life who fail the standard hearing screening.      Interventions and Evaluations Saliva samples will be obtained from participating infants with     a mouth swab according to an established protocol. The saliva will then be tested for CMV by     qualitative polymerase chain reaction by ARUP Laboratories. Infants who test positive for CMV     infection will then be referred for repeat audiology exam to confirm hearing loss and to     Pediatric Infectious Diseases for evaluation and treatment if necessary. Parents or guardians     of infants who test positive for cCMV will receive counseling on the importance of following     up with these specialists. The primary outcomes measured will be cCMV prevalence data and     time to referral and intervention.      Follow up:      Follow-up will be as clinically indicated and determined by the infant's primary care     provider, pediatric infectious disease physician, and audiologist. It will not be determined     by the study, referral to these services will be the study endpoint.   "
46211|NCT02680730|"     Purpose: A research project will be conducted at the ADD (Attention Deficit Disorder)     Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening     Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or     behavioral regulation. The LPP is designed as a neural exercise to reduce auditory     hypersensitivities, to improve auditory processing of speech, and to improve behavioral state     regulation. These improvements should translate into increase feelings of safety and     calmness, thereby promoting improvement in social behavior.      Participants: 30 participants, males and females between ages 7-55 years, will be recruited     for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of     Toronto.      Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will     have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and     1 month post intervention assessment. Group 2 will have an additional pre-intervention     assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the     stability of the measures prior to starting the intervention. Pre-, post-, and 1 month     followup assessment will include parent and/or self-report questionnaires, and measures of     the individual's auditory processing (SCAN), affect recognition (DARE Dynamic Affect     Recognition Evaluation), heart rate, prosody, RSA respiratory sinus arrhythmia (derived     from non-invasive ECG recording), and middle ear transfer function (MESAS - Middle Ear     Sound Absorption System).   "
46212|NCT02680717|"     This is a study designed to evaluate the comparative effectiveness of topical medications for     the treatment of circumscribed morphea.   "
46213|NCT02680704|"     The purpose of this study is to collect physiologic data from patients with severe brain     injury who require mechanical ventilation in order to describe the impact of ventilation,     specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).   "
46214|NCT02680691|"     The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke   "
46215|NCT02680678|"     Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of     preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid     infusions and their timing via perfusion index and plethysmographic variability index.   "
46216|NCT02680665|"     This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg     under actual medical practice.   "
46217|NCT02680652|"     This is an observational, case--control study with a single blood draw among two cohorts,     patients with CVID and healthy controls. Samples will be analyzed by cytometry (CyTOF) to     simultaneously examine the major signaling pathways of all circulating innate and adaptive     immune cell types as well as whole exome sequencing. The goal is to improve our general     understanding of the human immune response to infections and the diagnosis of CVID.   "
46218|NCT02680639|"     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and     mortality throughout the world, being the fourth leading cause of death in the world.      This study is designed to detect COPD participants with Expiratory Flow Limitation. EFL     occurs when the airways become compressed which usually results when a pressure outside the     airway exceeds the pressure inside the airway.      Participants will undergo study eligibility procedures at visit 1. At visit 2 participants     will undergo a baseline auto-EPAP (Expiratory Positive Airway Pressure) measurement. Then the     order will be randomized to three different treatment methods. Between each treatment there     will be at least a 10 minute washout period in order for CO2 to stabilize and return to     baseline.   "
46219|NCT02680626|"     Pain control after surgery is important for patient well-being and recovery. We are     interested in determining whether we can improve the duration of action of a local anesthetic     procedure (transversus abdominis plane block, or TAP block) by adding magnesium sulfate to     local anesthetics given to patients after total abdominal hysterectomy with or without     salpingo-oophorectomy.   "
46220|NCT02680613|"     The purpose of this study is to determine whether motivational text messages and/or travel     vouchers are effective in increasing cervical cancer screening rates in urban and rural     regions of Northern Tanzania.   "
46225|NCT02680548|"     Injections of local anesthetics (freezing) and steroids are often performed around injured     nerves in individuals with nerve injury-related pain. The current standard of medical care is     to inject a combination of local anesthetics and steroids around injured nerves, but there is     no proof that this is better than injecting only local anesthetic, or even just sterile salt     water. There is evidence to believe that injection of local anesthetic (without the steroid)     can calm the injured nerve, and provide pain relief from a few days up to a few months.     Injection of sterile salt water also has the potential to provide pain relief by breaking     scar tissue around the nerve, thereby relieving compression. The aim of this study is to     compare pain relief and possible adverse effects from these three different treatments for     foot and ankle nerve pain relief.      All 30 participants will be recruited over 9 months from the Altum Health clinic at Toronto     Western Hospital. 10 participants will be randomly assigned to each treatment. Each patient     will receive 3 injections over 3 weeks or so. Participants will have an in-clinic follow-up     at 1 month after the last injection, and a phone follow-up 3 months after the last injection.      This is a small-scale study, and information obtained from this study will help in planning     and conduct of a larger study with more participants. The larger study will help determine     the best possible option for injection in patients with nerve-related injury pain.   "
46226|NCT02680535|"     To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation     of prostate tissue using nanoparticle-directed laser irradiation.   "
46227|NCT02680522|"     Introduction: The Parkinson is one of the most common degenerative diseases of the central     nervous system , mainly characterized by resting tremor , rigidity, akinesia and postural     instability , also featuring the autonomic modulation of heart rate , which can lead to     reduced frequency variability heart . Some activities may modify the modulation , including     rehabilitation using virtual reality. Method: The research is interventional type , quantity     and prospective, where volunteers were chosen for inclusion and exclusion criteria and     divided into two groups , Control and Parkinson's, where they underwent 24 sections with     virtual reality physiotherapy three times a week . Analysis of the autonomic modulation of     heart rate was performed before and after the rehabilitation program with the frequency meter     Polar brand. Statistical analysis was performed in 5.2 Biostat program with Shapiro- Wilk     test to verify the normality , followed by t test to compare the data.   "
46228|NCT02680509|"     The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular     circulation in the affected fingers. This effect is analysed by performing cooling     plethysmography and nailfold capillary microscopy bilaterally, following a unilateral,     single-port thoracoscopic sympathicotomy.   "
46229|NCT02680496|"     The primary objective of the study is to investigate the energy consumption,     cardiorespiratory load and perceived exertion, and how these parameters change, during     walking with robot-assistance compared to walking on a treadmill and walking overground in     stroke patients.      A secondary objective is to investigate whether these changes or differences in energy     consumption, cardiorespiratory load and perceived exertion during walking with and without     robot-assistance in stroke patients are related to changes or differences spatiotemporal gait     characteristics.   "
46230|NCT02680483|"     Prospective registry of all new comers with Atrial fibrillation   "
46231|NCT02680470|"     Using modern technology, investigators will observe participants taking their TB tablets     three times per week using a mobile phone, iPod or computer with camera facilities in the     participants home environment.   "
46232|NCT02680457|"     Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The     long-acting insulin has showed to improve glycemic variability however the behavior of     insulin glargine versus insulin degludec is unknown.   "
46233|NCT02680444|"     Brief and cost-effective interventions teaching emotion regulation techniques can be feasibly     applied to promote mental health in University students. The tools of mindfulness (i.e.,     objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of     negative events) can mutually benefit one another to promote well-being. The current study     explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared     to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect     over five days. Time by condition interactions were analyzed with planned contrasts and     multilevel growth modelling.   "
46234|NCT02680431|"     The purpose of this study is to find blood plasma based biomarkers of disease progression in     neurofibromatosis type 1 (NF1). NF1 is associated with the development of benign cutaneous     tumors as well as a variety of malignancies. Analysis of plasma DNA and chemical composition     may provide tools for diagnosis and follow-up of NF1. The hypothesis of the study is that     NF1-associated tumor burden and malignant transformation of tumors can be detected in plasma.     To test this hypothesis, Finnish patients with NF1 are recruited and blood sample is taken.     Blood plasma is separated and analyzed chemically. DNA is then also extracted and quantified.   "
46235|NCT02680418|"     To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female     subjects.   "
46236|NCT02680405|"     Atopic dermatitis is a skin disorder with an itchy, red skin rash. This may be because     certain proteins are increased in the skin of AD patients. The increased expression of these     proteins play an important role in the development of AD and may increase the risk for     persons with AD to get skin infections and allergies.      There are very few non-invasive ways to diagnose and monitor the development and progression     of atopic dermatitis. The goal of this study is to develop laboratory tests, done on skin     samples collected by tapy stripping, that can be used for early detection and monitoring the     response to treatment for a variety of skin diseases, including atopic dermatitis.   "
46237|NCT02680392|"     This randomized, double blind controlled trial is designed to investigate the potential     benefits of radiofrequency in terms of analgesia and functional outcome, compared to the     conventional continuous adductor canal block, for patients undergoing total knee arthroplasty     for osteoarthritis.   "
46238|NCT02680379|"     The purpose of this study is to determine whether Lovastatin, Minocycline and the combination     Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X     individuals.   "
49445|NCT02638428|"     The purpose of this study is to evaluate the efficacy and feasibility of combination     chemotherapy with target agents according to the result of targeted deep sequencing in     pediatric patients with relapsed/refractory solid tumor or AML.   "
46239|NCT02680366|"     This study evaluates the addition of collagen scaffold loaded with autologous bone marrow     mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the     treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC     scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter     balloon.   "
46240|NCT02680353|"     To determine the postoperative analgesic efficiency of bilateral superficial plexus block,     patients are divided into two groups. Study group received bilateral superficial plexus     block, where control had none. Visual analog scale, opioid consumption and presence of     nausea-vomiting are recorded.   "
46241|NCT02680340|"     The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral     stem revision rate at 10 years.      The secondary purpose of this study is to provide 10 years of safety and effectiveness data     of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance   "
46242|NCT02680327|"     This is a prospective epidemiological pilot study to evaluate the feasibility of recruiting     and retaining patients in a large multicenter study that will audit Advanced Care Planning     (ACP) practices and satisfaction with End Of Life (EOL) communication and decision-making in     patients undergoing cardiac surgery using the current validated questionnaires and     methodology.   "
46243|NCT02680314|"     The goal of this study is to determine whether inducing labor with just one dose of     misoprostol, followed by treatment with oxytocin, will still be effective enough to increase     the chances of having a successful vaginal delivery as compared to using more than one dose     of misoprostol, followed by treatment with oxytocin.   "
46244|NCT02680301|"     The purpose of this study is to        1. Compare efficacy of 0.1% triamcinolone containing wet wrap as an ointment or as a cream          formulation in patients with moderate to severe atopic dermatitis        2. The relative patient/subject acceptance and adherence will also be compared between the          two wet wrap types   "
46245|NCT02680288|"     This is a randomized, cross-over, single-blind, placebo-controlled, single-center,     multiple-panel evaluation of the potential for oral lorcaserin to modify cocaine     self-administration in a laboratory setting. To prevent unauthorized drug use, study     medications will be administered as participants are confined during overnight stays at the     Medical Center. Non-treatment-seeking, regular cocaine users will receive oral treatment with     single doses of placebo, lorcaserin 10 mg (Panel 1), or lorcaserin 20 mg (Panel 2).     Afterwards, the subjective and reinforcing effects of intravenous cocaine will be measured in     a laboratory setting.   "
46246|NCT02680275|"     This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic     Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea     Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.      Patients with reproductive disorders who visited Research Medical Center of Family Health     Problems and Human Reproduction were recruited.   "
46247|NCT02680262|"     The trial will evaluate the effect on participation in organised screening programme of a     human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand     compared with the standard second reminder for regular screening.   "
46248|NCT02680249|"     Three way crossover study to assess the bioavailability of 656 under fed and fasted     conditions.   "
46249|NCT02680236|"     Art therapy offers benefits and support for a range of psychological symptoms caused by     cancer and its treatments, for example anxiety, stress, depression, sleeplessness, identity     or end of life concerns. Persistent post treatment pain that adversely affects quality of     life may be experienced by up to 50% of breast cancer patients. Factors such as depression,     fear, anxiety or lack of sleep are shown to increase pain and suffering in people with     cancer. A multitreatment approach treatment of cancer pain is therefore recommended. Art     therapy offers an opportunity to communicate the experience of suffering in a non verbal mode     and can be offered in addition to other treatment for pain. This pilot study proposes to     explore the effect of art therapy on breast cancer patients' perception of pain, and its     impact on daily functioning by offering four sessions of individual art therapy, spaced     between one to three weeks apart.   "
46251|NCT02680210|"     The study will be conducted over 18 months. The main objective of this study is to explore     the relationships between autobiographical memory and specific cognitive measures, as well as     emotional and behavioural measures in patients who have suffered a moderate to severe TBI.     Secondary objectives are to assess the psychometric properties of a self-defining memories     questionnaire and to characterize autobiographical memory in the TBI population.   "
46252|NCT02680197|"     The study was designed to investigate the efficacy and safety of different doses CHF5259 a     long acting muscarinic antagonist in patients with moderate to severe COPD.   "
46253|NCT02680184|"     A Multicenter, Two-Part, Open-Label, Phase 1b Clinical Study of CMP-001 in Combination with     Pembrolizumab or as a Monotherapy in Subjects with Advanced Melanoma   "
46254|NCT02680171|"     Spatial neglect is a common attention disorder after right hemisphere stroke and is     associated with decreased independence and quality of life. Despite its high prevalence in     the stroke population, there is currently no standard of care for the treatment of neglect.     Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into     clinical care has been limited likely due to the lack of standardized procedures. The     investigators have developed a computerized PA technique designed to better engage patients     and assist clinicians. In this study the investigators aim to evaluate the feasibility and     effectiveness of the computerized PA procedure in a typical health care setting, with the     hypothesis that the PA procedure will improve patient's neglect symptoms.   "
46255|NCT02680158|"     The purpose of this study is to compare acute tear production produced by the Oculeve     Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous     tear deficiency.   "
46256|NCT02680145|"     This is a single center, prospective trial of pessary use prior to reconstructive pelvic     floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in     pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally,     we will assess the impact that preoperative pessary use has on patient self-reported     preparedness for surgery.   "
49446|NCT02638415|"     The purpose of the study is to compare the effect of HVPG-guided individualized therapy and     non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.   "
46260|NCT02680093|"     Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring.     physiological parameter of cervical length will be measured as the differential predictor to     determine their due date. the cervical length will be measured as part of routine gynecologic     examination to women who come for routine over due date follow up.      additional medical data will be collected from the patient medical record.- demographic data,     and all the routine prenatal medical care the women will receive up to the delivery.and     delivery outcomes.   "
46261|NCT02680080|"     The list of medications that prolong the QT interval and can provoke torsade de pointes keeps     expanding. This list includes not only antiarrhythmic drugs, but also medications with no     cardiac indications. All these medications prolong the QT interval because they block a     specific potassium channel on the myocardial cell membrane: the channel for the rapid     component of the delayed rectifier potassium current or IKr. The risk for developing     torsade de pointes for patients taking any of the medications with IKr blockade capabilities     varies from >4% for antiarrhythmic drugs to <0.01% for non-cardiac medications. The risk     depends on the strength of IKr blockade, but also on specific patient characteristics. The     majority of patients who develop torsade de pointes from non-cardiac medications have     identifiable risk factors. In this regard, patients with a congenital long QT syndrome are     prone to develop torsade de pointes when treated with QT-prolonging medications. This is     because, due to their genetically defective ion channels, patients with Long QT Syndrome     (LQTS) have impaired ventricular repolarization and reduced repolarization reserve.     Therefore, it is common medical practice to strongly advise patients with congenital LQTS to     avoid all medications that have IKr channel blocker capabilities. it was reported that some     flavonoids contained in pink-grapefruit juice block the IKr channel. These investigators also     reported that drinking 1 liter of pink-grapefruit juice causes QT prolongation in healthy     volunteers. The magnitude of the QT prolongation provoked by grapefruit juice was small     However, drugs causing minor QT prolongation in healthy volunteers may provoke major QT     prolongation in rare or sick individuals who are then at risk for developing torsade de     pointes. Consequently, one could argue that, until proven otherwise, pink-grapefruit should     be added to the list of drugs that are forbidden for patients with LQTS   "
46262|NCT02680067|"     In this phase 1 study, the lymphatic transport will be examined using Near InfraRed     Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities in healthy     individuals using a MultiSpectral Imaging System (MSImager).   "
46263|NCT02680054|"     The aims of the study are to see if additional insulin doses for the fat and protein in a     meal, given at different times, improve blood glucose levels and are safe and acceptable to     children with Type 1 diabetes using multiple daily insulin injections.   "
46264|NCT02680041|"     This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent     prostate cancer after curative-intent primary therapy and negative or equivocal findings on     standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine     PET/CT. Site clinicians will manage study subjects per standard practices and will document     any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants     will be followed for up to 6 months, with clinical data collected for this study. An     interdisciplinary panel will provide expert guidance to local readers on request. The final     reporting of the PET/CT scan will be a single report by the local reader following any such     discussion.   "
46265|NCT02680028|"     In England each year over 65,000 people fracture their hip. Most of these patients are     elderly females with the fracture occurring after a simple trip or stumble. Approximately     half of these fractures are classified from their relationship to the hip joint capsule as     extracapsular. The majority of these fractures are treated surgically by internal fixation     using, either a plate and screws (sliding hip screw) or nail and screws (intramedullary     nail).      Recent randomised studies from Peterborough involving 1000 patients have indicated that there     are modest benefits for treating this type of fracture with an intramedullary nail in     comparison to a sliding hip screw. This study aims to progress from these earlier studies to     determine if a slightly thinner and shorter intramedullary nail (175mm in length), has any     significant advantages or disadvantages to the standard length (220mm) intramedullary nail.      Both implants to be used in this study are in routine use around the world and are being used     within their licenced indication. The study is therefore using two different designs of     implant within their recommended area of use, but in which there is uncertainty as to which     is the best design.   "
46266|NCT02680015|"     This study examines how the PEERS (Laugeson & Frankel, 2010; Laugeson, 2016)     social-behavioral intervention affects social relationships, and brain development and     function in adolescents and young adults with autism spectrum disorder.   "
46267|NCT02680002|"     The main purpose of this study is to assess the usability of long-term stored H5N1 antigen     and adjuvant. The study is designed to assist in stockpile management by assessing the     safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine     when administered with or without MF59® adjuvant.   "
46268|NCT02679989|"     An intermittent energy restricted (IER) diet may modify cardio-metabolic disease risk factors     compared to an energy-matched continuous energy restricted (CER) diet. A randomised     controlled parallel design trial will determine the impact of a short-term IER diet (2     consecutive days of very low calorie diet (VLCD), 5 days moderate energy restriction each     week for a 4 week period), compared to a CER diet, on insulin sensitivity in healthy     (disease-free) subjects with central obesity.   "
46269|NCT02679976|"     This is a single-visit prospective study to establish a real world Marketed Contact Lens     'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes     and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40     years of age or older, for a 1-visit, 4-hour study for measurements to be taken.   "
46291|NCT02679690|"     Develop an evidence-based intervention aimed at patients with heart failure (HF) using     color-coded cue cards to assist in the selection of foods appropriate to their sodium     restricted diet. The milligram per serving sodium content of foods will be assigned     color-coded green/yellow/red designation according to very low/moderate/high as identified by     the United States Food and Drug Administration's definitions of sodium content.      Assess patient knowledge of foods with sodium content appropriate for consumption on a low     sodium diet before implementation of the intervention by calculating average milligrams of     sodium per serving via choices made through simulated grocery store shopping.      Evaluate application of patient knowledge about low-sodium food choices using a simulated     grocery store shopping intervention by calculating average milligrams of sodium per serving     via choices made using the color-coded card.   "
46328|NCT02679196|"     Multiple ascending dose study to evaluate safety/tolerability, pharmacokinetic and     pharmacodynamics effects of KA2237 (PI3 Kinase p110β/δ Inhibitor) in patients with B Cell     Lymphoma and determine the maximum tolerated dose (MTD) in Part I of the study. In Part II,     patients with B cell lymphoma will be treated with KA2237 at the MTD to evaluate safety and     efficacy in the patient population.   "
46270|NCT02679963|"     This is a multicentre randomised double-blind phase II trial, sponsored by Gustave Roussy and     involving one French center as well as the Spanish Lung Cancer Group (≈20 centers of the     SLCG).      Six hundred patients with diagnosis of stage IIIB/IV NSCLC will initially be registered prior     to receiving the first line platinum-based chemotherapy or during or at the end of the first     6 cycles of inducation platinium based chemotherapy and provide consent for retrieving     archival tissue collection and providing translational blood samples and tumor biopsies.        1. - Induction chemotherapy phase All patients will initially be treated with 6 cycles of          platinum-based induction chemotherapy. Cycle duration will be 21 days. Doublets should          either consist of a pemetrexed-platinum (cisplatin or carboplatin) doublet          (preferentially for non-squamous NSCLC) or a gemcitabine - or vinorelbine - platinum          doublet for squamous NSCLC. Taxanes-platinum doublets will not be accepted.          Translational blood samples will be taken at the beginning of induction chemotherapy for          all patients.           Patients displaying progressive disease or stable disease after induction chemotherapy          will be withdrawn and further optimally managed according to local practice. For them,          an optional tumour biopsy will be performed at the end of the induction treatment.        2. - Randomisation and maintenance phase Only patients who respond to platinum-based          induction chemotherapy will be further randomised between olaparib and placebo. These          patients must have been treated with 6 cycles of chemotherapy. However, patients who          haven't received 6 cycles of the induction chemotherapy due to severe toxicity (grade 3          or 4, NCI CTCAE v4.0) could be randomized only if they had received 4 chemotherapy          cycles at least and if all treatment related toxicities are resolved to a grade ≤ 1 (NCI          CTCAE v4.0).      Treatment will be administered at a dose of 600 mg daily (2 doses of 300 mg [2 tablets of 150     mg] taken approximately 12 hours apart) and cycle duration will be 28 days. Disease will be     assessed every 2 cycles by CTscan (MRI or PET-scan if the scan is not contributive) and     treatment will be administered until disease progression or unacceptable toxicity. Patients     will then be optimally managed according to local practice. Follow-up will be for a minimum     of 15 months from the time of randomization, and until last venue. All randomised patients     will be asked to provide translational blood samples at randomization, on treatment and at     the end of the treatment. Optional tumour biopsies will be performed at randomization, at the     end of the treatment (or at disease progression if available).   "
46271|NCT02679950|"     The current proposal is a pilot study. The Investigators plan to use next generation genome     sequencing (NGGS) to define the molecular and genetic profiles of 3 cases of germ cell tumor     (GCT) (with a component of yolk sac tumor) at the time of the initial diagnosis and 3 cases     of late relapse GCT's, which are characterized by yolk sac tumor (and AFP secreting)     predominant disease.      Investigators seek to demonstrate the feasibility of obtaining tissue biopsies (either     archived or new biopsy) and utilization of NGGS in studying the molecular and genetic     relationships between GCT's (with a component of yolk sac tumor) at the time of diagnosis and     GCT's at the time of late relapse. This study will also provide preliminary information on     genetic alterations, which may be a hypothesis for generating another study.   "
46272|NCT02679937|"     This randomized controlled trial assesses the efficacy of a 6-week, dissonance-based,     weight-gain prevention program (Fit4Duty) designed to reduce unhealthy weight gain among     military service members at-risk for obesity. The Fit4Duty program is an adaptation for the     military of an existing civilian obesity prevention program, Project Health, which reduced     obesity onset by 50% in healthy civilian young adults. Fit4Duty is compared to a nutrition     education control condition and is hypothesized to reduce excess weight gain beyond the     control comparison program during the 2 year period following study participation.   "
46273|NCT02679924|"     Soft tissue augmentation with injectable hyaluronic acid (HA) is a well-established modality     for the correction of facial volume loss, fat atrophy, fine lines, and wrinkles. HA is a     glycosaminoglycan that is composed of repeating D-glucuronic acid and D-N-acetylglucosamine     disaccharide units. Because HA is a natural and inert constituent of the dermis, it     represents an ideal substance for soft tissue augmentation. Current FDA-approved HA fillers     are typically utilized to either directly target specific cutaneous rhytids or to restore     overall contours by placement into fat pads or along bony structures that have remodeled with     age. Restylane® Silk is a transparent injectable HA gel that received FDA approval in June     2014 for use in the lips and peri-oral region. Its unique synthesis results in smaller and     finer particles that demonstrate significant hygroscopic properties and give rise to the     potential for unique applications. One such application concerns the concept of skin     boosting whereby microaliquots of HA are placed into the skin to induce biophysical     improvement in dermal characteristics (1). Using this technique, a recent split-body study by     Streker et al. demonstrated significant aesthetic improvements in face, hands and décolletage     (2). However, there have been no well-controlled studies with validated aesthetic outcomes     utilizing Restylane® Silk in this fashion to date. Because of the unique combination of     ultra-fine product and high water-attracting capability, the investigators hypothesize that     microinjections of Restylane® Silk can be used in a grid-like injection pattern for     rejuvenation of the aging cheek.   "
46274|NCT02679911|"     The main objective of this study is to compare subject's compliance and satisfaction for two     modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl     NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).   "
46275|NCT02679898|"     Obesity is directly related to arterial dysfunction and negatively associated to muscle     strength. High-intensity resistance exercise is the favored modality to offset muscle     weakness, yet, adverse effects on arterial function (pulse wave velocity, wave reflection,     and aortic and brachial blood pressures) have been observed. Conventional unloaded-whole body     vibration training (WBVT) has improved arterial function in overweight/obese women but     appears to be low-intensity. Nevertheless, the effects of moderate-intensity (by adding     external load) WBVT on arterial and muscle function are unknown. Therefore, the purpose of     this study was to examine whether loaded-WBVT would induce greater benefits than     unloaded-WBVT on arterial and muscle function in young overweight/obese women. Furthermore,     we examined whether these changes were similar to healthy lean young women.   "
46276|NCT02679885|"     It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be     found in low concentrations in semen. Because the drug has been associated with     teratogenicity in laboratory animals, the question is raised as to whether the drug can be     detected in female partners of sexually active males who are taking the drug to treat their     multiple sclerosis.   "
46277|NCT02679872|"     Good non-technical skills (NTS) have been shown to prevent adverse events and errors.     Improvements of NTS can be achieved by simulation based-team training.The NTS of the     operating theatre team performing video-assisted thoracoscopic surgery (VATS) is speculated     to differ fra open thoracic surgery, as is the case with technical skills; however, these     have not been investigated. The aim of this study is to explore which NTS the members of the     VATS team perceive to be most important to patient care and safety. Exploration will be done     through a deductive, qualitative analysis of semi-structured group and individual interviews     with VATS team members. A theoretical perspective of Hollnagels Safety-II will be taken using     the taxonomy of Oxford Non-Technical Skills (NOTECHS) system with the aim of informing     patient safety.   "
46278|NCT02679859|"     The primary hypothesis of the BETTER pilot trial is that B-type natriuretic peptide (BNP)     directed medical therapy prior to noncardiac surgery will be associated with improved     cardiovascular outcomes, when compared to standard of care.   "
46279|NCT02679846|"     SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with     Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of     analysis.      The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long     term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This     non-standardised medical practice, which aims at promoting the occurrence of seizures during     the time limit of the monitoring period, exposes patients to significant risks which should     be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal.      SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term     VEEG monitoring on the frequency of seizure-related serious adverse events occurring during     these monitorings and on the ability to obtain VEEG recording of seizures within appropriate     time limits.      10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs     withdrawal will be used systematically, while the other ten EMUs will continue their current     non-standardised practice of AEDs withdrawal, and will serve as a control group.      The setting of the study will include a 6 months evaluation phase, prior to randomisation,     during which the organisational characteristics, baseline EMUs' activity, current management     of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center     will be evaluated.      The standardised study protocol of AEDs withdrawal has been defined on the basis of a     systematic review of all relevant publications in the field.   "
46280|NCT02679833|"     A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with     vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome     variable is the difference in the change of methylmalonic acid after 3 months between the two     study arms.   "
46281|NCT02679820|"     The immediate post cesarean section IUD insertion is a further step towards spreading more     compliance to females in developing countries, with rapid increase in population size   "
46282|NCT02679807|"     This is a randomized, double-blind placebo controlled trial to evaluate the effect of a     probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the     experimental rhinovirus challenge model. A previous study documented that Bl-04 has     significant effects on the innate immune response in the nose and this study will be powered     to assess whether these effects translate into a demonstrable clinical benefit. Volunteers     will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary     analysis will be on the proportion of volunteers who develop a rhinovirus associated illness     in the two treatment groups.   "
46283|NCT02679794|"     The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and     vegetables daily but the average intake of US adults is only 2.6 cups. This low consumption     of fruits and vegetables results in a limited availability of certain nutrients found in     these foods such as carotenoids. Dietary carotenoids have health-promoting properties and are     known to fight against disease. Although, maintaining adequate vitamin D status is critical     for overall skeletal health and the prevention of osteoporosis, vitamin D insufficiency is     also widespread in the United States. Eggs, egg yolk in particular, are known to be a good     source of lipid and may improve the absorption of carotenoids and vitamin D found in     co-consumed vegetables in young and older women. Therefore, the investigators are interested     to see if consuming eggs with cooked vegetables will increase carotenoids and vitamin D     absorption.   "
46284|NCT02679781|"     The general objective of the study is to compare the efficacy of administering midazolam     orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure:     1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum     working time.   "
46285|NCT02679768|"     Very little is known of depressed patients' mental state after being discharged from     inpatient wards where they are provided with a sheltered environment with stable sleep wake     cycle, regular meals, and regular physical and social activities. Our previous usability     study, SAFE I, showed that electronic self-monitoring was a useful tool to gain insight into     patients' condition in the weeks after discharge. Results showed that patients over a four     week period had significant day to day variations in self-rated mood and sleeping schedule     and that the patients' sleep patterns were delayed with 45 minutes.      In the actual study, SAFE II, we are investigating whether an intervention with a strong     focus on the circadian timing of daytime activities, and sleep, coined Circadian     Reinforcement Therapy (CRT), can lead to a faster recovery of depression and prevent relapse     into depression after discharge.   "
46286|NCT02679755|"     A study of palbociclib in combination with letrozole as treatment of post-menopausal women     with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole     therapy is deemed appropriate.   "
46287|NCT02679742|"     A randomized, double-blind, placebo-controlled, parallel study to assess the effects of     β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute     process in older patients with sarcopenia in terms of muscle mass, muscle strength and     physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a     resistance training program or placebo with a resistance training program.   "
46288|NCT02679729|"     This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better     understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects   "
46289|NCT02679716|"     Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. In     computational fluid dynamics (CFD) studies [Kaufmann et al. 2012] 10% of ascending emboli     caused RAO, the residual 90% embolized into the cerebral arteries. As only 20% of patients     with RAO had a history of stroke [Wang et al 2006, Leisser et al 2010-2014], there is a     discrepancy between CFD-studies and clinical observations. Mead et al. [7] postulated small     emboli being washed into the cerebral arteries without causing clinical symptoms of stroke,     whereas similar emboli being washed into the ophthalmic artery would cause RAO.      There is a discrepancy between CFD-study results and clinical observations in RAO patients,     indicating that there could be a high number of RAO-patients having had cerebral ischemies     without symptoms of stroke (as postulated by Mead et al. 2002).      Purpose of the present study is to evaluate hemodynamic pathological changes at the     ophthalmic artery origin in patients with RAO detected with an already existing CFD-model   "
46290|NCT02679703|"     To evaluate the effect of the polarity of the electric current in healing.   "
46292|NCT02679677|"     The typical clinical progression of COPD usually results in a decreased level of tolerable     physical exertion for the patient. The avoidance of strenuous physical activity leads to a     deteriorating level of physical fitness, which further decreases the patient's ability to     undertake physical activities. Recent research has shown that whole body vibration has the     potential to improve physical fitness of participants, including such measures as the 6     minute walking distance. However, information concerning lung function is lacking.      The goal of the study is to test whether the use of whole body vibration training has an     effect on the lung function of patients with stable COPD, or if the previously observed     effects can be attributed to either pharmaceutical therapy or physical therapy interventions.   "
46293|NCT02679664|"     The SAVER pilot is a randomized, open-label pilot study to determine the feasibility of     recruitment. In addition to feasibility data, the investigators will carefully collect     clinical data to determine if rosuvastatin can reduce post-thrombotic syndrome (PTS) in     venous thromboembolism (VTE) patients.      Eligible consenting patients who developed acute, symptomatic, and objectively confirmed     proximal leg deep vein thrombosis (DVT) and/or PE will be randomized and equally allocated to     2 trial arms, either the treatment group (rosuvastatin tablet (20 mg/day) or the control     group (usual care). The pilot trial consists of up to 4 study contacts over 6 months:     screening, randomization, telephone follow-up (90 days), and final study visit (180 days).   "
46294|NCT02679651|"     The investigators hypothesize that there is a difference in plantar tissue thickness, plantar     pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to     healthy, foot-type matched controls. Results will be measured objectively using ultrasound     for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain     and disability index (MFPDI) for pain score. Furthermore, investigators predict that these     results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as     determine which patients would receive greatest benefit from fat grafting to the foot.   "
46295|NCT02679638|"     A Multi-center Cross-sectional quantitative study with a preliminary qualitative study part     aiming to identify and analyze demand factors, supply factors and perceptions affecting     Breast Cancer patients' treatment choices of Breast Cancer patients in 5 key decision points:     participation role in the decision making process, hospital choice, treatment regimen choice,     surgical extent and surgeon choice. 25 patients and caregivers will participate in the     qualitative part and 425 Israeli Breast Cancer patients will participate in the quantitative     study.   "
46296|NCT02679625|"     Accurate assessment of fluid responsiveness (FRes) is central to guiding fluid management in     septic and critically ill patients. As evidence accumulates that both inadequate and     excessive fluid resuscitation are associated with increased morbidity and mortality, it is     simultaneously becoming increasingly clear that current widely used methods to predict FRes     are of questionable accuracy. The optimal technique to predict FRes would be a non-invasive     point-of-care test with not only a high degree of accuracy, but also one which requires     minimal training to perform correctly and may be easily performed repeatedly for serial     evaluation of FRes during the ongoing management of the critically ill patient.      To date, three major ultrasonographic modalities have emerged as viable candidates for the     bedside assessment of FRes: 1) measurement of dynamic changes in inferior vena caval diameter     (IVC-CI), 2) measurement of dynamic changes in peripheral arterial waveform derived variables     (PA Doppler), and 3) echocardiographic measurement of dynamic changes in left ventricular     outflow tract waveform derived variables (LVOT Doppler). In this study, the investigators     will perform the first direct comparison of techniques representing all three of the above     modalities in the prediction of FRes against a non-invasive bioreactance cardiac output     monitor (the Cheetah NICOM™), which has been extensively validated against gold-standard     invasive methods of cardiac output measurement. The investigators will compare the accuracy     of these modalities in both spontaneously breathing and mechanically ventilated patients     using passive leg raise testing (PLR) as a surrogate for volume challenge. In addition, the     investigators will also elicit information from the treating physician(s) on their clinical     assessment of FRes.      The investigators will recruit adult patients in the ED and ICU with sepsis, who have     received an initial bolus of 20-30 cc/kg of IV fluid, and can tolerate the PLR and US     procedures. Prior to US and NICOM measurement, investigators will ask the attending physician     managing the patient regarding their assessment of the their fluid status. Then, separate     investigators will perform US and NICOM measurements independently to ensure blinding. NICOM     data, which has been well validated in septic patients, will be shared with the attending     physician. They will then be asked if this new data will change management.   "
46297|NCT02679599|"     Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not     attending rehabilitation and there is a steep drop off in exercise following rehabilitation     completion. Moreover, little is known about the amount of time that cardiac rehabilitation     patients spend in sedentary behavior, which is associated with increased risk of     cardiovascular morbidity and mortality, independent of time spent in exercise. This pilot     study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone     application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity     physical activity accumulated in bouts of at least 10 minutes in duration (i.e. bout-related     MVPA) and decrease time spent in sedentary behavior. Up to 32 patients will be recruited,     enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1)     B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone. Participants     will complete 7 days of objective activity monitoring to measure daily minutes spent in     bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation     (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks). At     these same time points, participants will complete questionnaires assessing sedentary     behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect. At     baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure     cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning.     Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the     4-week follow-up.   "
46298|NCT02679586|"     This is a single-arm, single-institution pilot study that will collect preliminary data to be     used in the design of a subsequent study to assess whether changes in fDM (Functional     Diffusion Maps) derived from primary breast cancer diffusion weighted MRI images can serve as     an early predictor of response to treatment, and whether the magnitude of the change     correlates with the effectiveness of treatment.   "
46299|NCT02679573|"     The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to     moxifloxacin in the treatment of adult patients with community-acquired pneumonia.   "
46325|NCT02679235|"     BEAT7-001 is a randomised, open label, two parallel group study (supplementation versus     control). Using a multi-modal brain imaging portfolio, this study will assess whether brain     energy metabolism (glucose and ketones), structure or functional connectivity change in older     people with frontal glucose hypometabolism after 28 days on an oral dose of 1 g/kg/day of     triheptanoin.   "
46300|NCT02679560|"     This is an investigator-initiated, single-center, randomized, patient blinded, controlled     trial. The purpose of this study is to compare the effect of a fascia iliaca compartment     block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or     hip fractures admitted to the University of California Davis Medical Center (UCDMC). The     primary endpoint will be the total opioid requirements during the 72 hour randomization     period with secondary endpoints including total daily opioid requirements for days 1-3,     duration of effect and objective pain scores using the numeric rating scale (NRS) during     their hospital stay.   "
46301|NCT02679547|"     Appendectomy is the most common emergent operative procedure performed worldwide. In this     study investigators will investigate if there is a relationship between breast feeding and     appendicitis in adults.   "
46302|NCT02679534|"     Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the     multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that     cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high     as 74% despite the use of analgesics. The highest pain intensity is experienced in the first     24 hours post surgery when patients are still in the ICU, and represents a strong predictor     for the presence and severity of persistent postoperative pain. To maximize pain relief,     massage has been suggested in the recent clinical practice guidelines of the Society of     Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its     opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed     promising pain relief effects of massage when administered to cardiac surgery patients in     acute care units, however, its effects on pain relief while patients are still in the ICU and     when pain severity is highest remain unknown.      This study aims to compare the effect of three 20-minute hand massage administrations within     24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain     interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory     rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding     (i.e., simple touch) and standard care. Other objectives are to describe the location and     quality of pain of cardiac surgery ICU patients.      Hypothesis:      Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity,     unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients     receiving hand holding and to those in the standard care group.   "
46303|NCT02679521|"     Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an     efficient treatment option for heel pain associated with chronic proximal plantar fasciitis     when administered in three sessions. The present study tested the hypothesis that heel pain     associated with chronic proximal plantar fasciitis can also be treated successfully with     rESWT when only two treatment sessions are performed.   "
46304|NCT02679508|"     The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and     the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in     patients receiving maintenance treatment after healed erosive esophagitis (EE), and the     curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.   "
46305|NCT02679495|"     The purpose of this study is to determine whether positive life style interventions (such as     diet modification and smoking cessation) are effective in the prevention of gastric     pre-cancer and cancer occurrences and reccurence of gastric cancer after edoscopica     resection.   "
46306|NCT02679482|"     The purpose of this study is to follow and describe the outcomes of patients after selective     and pascal laser trabeculoplasty treatment for chronic open-angle glaucoma.   "
46307|NCT02679469|"     The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in     healthy Japanese male subjects will be evaluated.   "
46308|NCT02679456|"     This is a randomized, multicenter, evaluator blinded study to evaluate the safety,     tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult     patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent     episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled     and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose     regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of     treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation     period visit) or at any time that a recurrence or clinical failure is suspected, up to the     end of observation period.   "
46309|NCT02679443|"     Folic acid (FA; folate) in the dose of 350-1,000 μg daily should be supplemented, daily,     starting 7 days before the first dose of pemetrexed based chemotherapy and should be     continued while the patient is on therapy and for 21 days after cessation of therapy. Vitamin     B12 injections (1,000 μg i.m.) should also be started 1 week before the first dose of     chemotherapy. However, the evidence for delaying chemotherapy by seven days for the purpose     of giving vitamin B12 and FA supplementation is not robust. Observational and prospective     single arm studies have not shown any increased toxicity if pemetrexed was started earlier     than the recommended duration of supplementation. In a resource constrained setting, this     will lead to one additional visit and 1-week chemotherapy delay which may be inconvenient for     patients.      Hence an open label, randomized control trial is being undertaken to evaluate if there are     any differences in pemetrexed related hematological toxicity amongst patients who receive     delayed initiation of chemotherapy (following 5 - 7 days of vitamin B12 and FA     supplementation; Delayed Arm) as compared to those in whom vitamin B12 and FA supplementation     is starting simultaneously (within 24 hours) of initiation of chemotherapy (Immediate Arm).   "
46310|NCT02679430|"     Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to     uterine fibroid embolization for women, is safe and effective.   "
46311|NCT02679417|"     The type of physical activity such as, aerobic or resistant exercise required to reduce liver     fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The     purpose of this study is to determine whether aerobic exercise should provide improvement of     hepatic fat content and inflammation as well as metabolic profiles and anthropometric     parameters better than resistant exercise.   "
46326|NCT02679222|"     The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils     (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each     oil are evaluated individually or in combination over a 8h-period during which repeated blood     sampling is performed.   "
46312|NCT02679404|"     Multi-center, International, Prospective, Non comparative, Non randomized, Open label.      5,000 patients to be enrolled approximately worldwide.      The objective of this registry is to collect safety and clinical performance post market data     related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance     with the Instructions for Use (IFU).      This observational global registry is intended to collect data without requiring any     deviation from the standard of care and IFU in each participating center. The participating     centers shall include those patients that have provided their informed consent to participate     in this registry in accordance with the local applicable regulations.   "
46313|NCT02679391|"     The primary aim of this study is to compare early surgical complications after abdominoplasty     performed by plastic and general surgeons. Secondary aims were to assess whether specific     guidelines might have impact on the rate of complications. The hypothesis is that general     surgeons have more complications.   "
46314|NCT02679378|"     Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study     comparing ClearSight system to histopathological to determine negative-margins in breast     conserving surgery.   "
46315|NCT02679365|"     In this trial we compare the effect of 2 closure techniques of the rectus sheath during     cesarean sections on postoperative pain. One closure technique is double lock technique and     the other is the conventional continuous non-locking technique.   "
46316|NCT02679352|"     Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint     diseases to relieve pain and restore shoulder function.      Shoulder implants commonly used are characterised by a humeral stem and complications related     to the stem are not infrequent. These include: bone stock loss, intraoperative and     postoperative break around the implant, malpositioning of the humeral component and difficult     eradication of infections inside the bone around the implant.      With the aim of reducing stem-related complications, a novel prosthesis characterised by a     stem-less design has been developed.      The objective of this study is therefore to explore how well people recover after shoulder     replacement with this novel stem-less shoulder prosthesis. This will be assessed over 5 years     in three different countries in Europe using patient completed questionnaires and clinical     and radiographic assessments.   "
46317|NCT02679339|"     Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled     design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be     evaluated in subjects with acute-onset herpes zoster pain.   "
46318|NCT02679326|"     The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the     treatment of Plantar fasciitis (PF).   "
46319|NCT02679313|"     This study will compare near clinical oculomotor parameters (heterophoria, vergence ranges,     AC/A and accommodative findings) measured when lenses and/or prisms are introduced using     three different instruments namely: (i) a standard manual phoropter, (ii) an electronic     phoropter and (iii) a wearable adaptive refractor (VisionFit).   "
46320|NCT02679300|"     Immersion in a virtual reality environment has been shown to reduce pain during a variety of     painful medical procedures, such as wound care for burn patients and dental care. Often,     serious games are used to distract patients from this painful procedures. Recently, serious     games have also been developed for patients with low back pain. Because patients with low     back pain frequently experience pain during exercises, the investigators hypothesize that     exercising with serious games can reduce the pain intensity and the time spent thinking of     pain during exercises. To test this hypothesis, the investigators will conduct a randomized     controlled trial where two groups will be compared: the experimental group will perform one     session of exercises with serious games, while the control group will perform one session of     the same exercises without the serious games.   "
46321|NCT02679287|"     The purpose of this study is to use an investigational type of technology called Closed-Loop     Control (CLC) Medical Platform System to help control blood sugar in people with type 1     diabetes mellitus in a home setting.   "
46322|NCT02679274|"     Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home     residents. Testosterone treatment is among the potentially beneficial treatments in addition     to resistance exercise for improving muscle strength and mass in frail adults. The     investigators have demonstrated that cycled administration of testosterone improves muscle     mass and strength in healthy adults. It is proposed that cycled testosterone administration     may be an effective adjuvant therapy for frail older men and women during rehabilitation     programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC)     rehabilitation will result in improved muscle mass and physical function when compared to     patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled     study, the investigators will test the effects of cycled testosterone administration (2 week     on treatment, 2 weeks off treatment) on body composition and physical function in male and     female nursing home residents undergoing rehabilitative care. Primary outcomes will be     assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip     dynamometers, short physical performance battery (SPPB), and quality of life (QOL)     questionnaires. Data from this pilot project will become the foundation for the development     of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of     testosterone treatment on physical function and independence in frail older adults.   "
46323|NCT02679261|"     Bicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of the     population. The aortic dilation and aortic valve degeneration are common complications in     patients with BAV. Statins have shown a reduction in the expression of metalloproteinases of     the extracellular matrix observed in aortic aneurisms. Several retrospective studies have     suggested the benefit of the statins to reduce aortic dilation in patients with BAV.     Moreover, although statins did not show to be useful in the progression of aortic stenosis,     different studies have suggested a higher profit when the valve affection is not severe. The     objective of this study is to determine whether atorvastatin is effective at reducing the     progression of aortic dilation in patients with BAV.   "
46324|NCT02679248|"     This study will investigate the effect of a nitric oxide supplementation product, Neo40     Daily®, on blood pressure in pre-hypertensive and mildly hypertensive adults. Subjects will     take 2 lozenges per day 12 hours apart for 8 weeks. Half of the subjects will receive Neo40     Daily® and the other half of the subjects will receive placebo.   "
46329|NCT02679183|"     Honey is a natural product that contains multiple nutrients; it is composed of fructose,     glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also     contains more than 180 substances including amino acids, vitamins, minerals and enzymes.     Investigators hypothesized that supplementation of enteral feeds with honey would produce a     bifidogenic effect and stimulate the immune response in preterm infants. Investigators     randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2     weeks and measured their effect on stool colonization, systemic immune parameters and     anthropometric measurements.   "
46330|NCT02679170|"     Prospective Observational Study To Identify Patients With Advanced/metastatic Non Small Cell     Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management under     clinical practice (IDEALK)   "
46331|NCT02679157|"     Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care     Unit Stay - a multinational, observational study      Objectives:        1. To investigate associations between potential risk factors (premorbid factors, in-ICU          treatments/diagnoses and patient status at ICU discharge) and three-month physical and          psychological outcome in ICU survivors.        2. Based on the associations between identified risk factors and adverse outcomes, create          and validate instruments, to be used at ICU discharge, predicting new-onset physical or          psychological problems three months after ICU discharge.      Study design:      Prospective, observational multi centre (10 centres) cohort studies      Outcomes:      Adverse psychological outcome three months after ICU discharge (Posttraumatic Stress     Syndrome-14 (PTSS-14) part B score >45 or Hospital Anxiety and Depression Scale (HADS)     subscale score >10). New-onset physical disability, defined as a reduction in Barthel Index     ≥10 points compared with 2 weeks prior to hospital admission.      Study duration:      Recruitment of patients during 2-4 months in the ten study sites. Follow-up of primary     endpoints 3 months after ICU discharge.      Number of subjects:      The aim is to screen all eligible patients and include 600-1000 ICU survivors during the     recruitment period. The final number of included patients depends on case-mix in the units     and potential exclusions.      Population:      Adult patients (18 years or older) discharged from ICU.   "
46332|NCT02679144|"     Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter,     study for patients with neuroblastoma in remission. In this study subjects will receive 730     Days of oral difluoromethylornithine (DFMO) at a dose of 500 to 1000 mg/m2 BID on each day of     study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are     in remission as a strategy to prevent recurrence.   "
46333|NCT02679131|"     A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in     patients with relapsed/refractory solid tumors or hematological malignancies in patients with     renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based     on their level of renal function (normal, mild, moderate, or severe renal impairment) and     receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or     severe renal impairment.   "
46334|NCT02679118|"     This study will determine the ability of the device to draw a small amount of gas from an     insufflated abdomen during laparoscopic surgery and accurately detect if gaseous content from     the bowel is present.   "
46335|NCT02679105|"     The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy     in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be     treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10     000 SQ-U, or placebo.   "
46336|NCT02679092|"     Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate     pre-operative preparation of the uterine cervix is an important part of preventing     complications of the procedure. Traditionally, the uterine cervix is prepared for the     procedure using water-attracting dilators, which are placed via a speculum exam and cause     discomfort for many women. The objective of this study is to investigate the comparative     effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for     D&E.   "
46337|NCT02679079|"     Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of     NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will     enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette     Syndrome.   "
46338|NCT02679066|"     There is no consensus regarding the need to immobilize the elbow in immediate immobilization     of closed distal radius fractures post-reduction. Decreased functionality of the upper     extremity is a notable morbidity associated with below-elbow splinting of distal radius     fractures post-reduction. Few studies have provided evidence comparing sugar tong splinting     versus short-arm casting as methods of immediate post-reduction immobilization. The study     will randomize patients with close distal radius fractures to short forearm casting versus     sugar tong splinting with close follow up including radiographic and clinical evaluation.      This will provide guidance regarding the need for short forearm cast immobilization versus     sugar tong splinting in early maintenance of reduction of closed distal radius fractures, as     well as functional effects of sugar tong splinting versus short forearm casting.   "
46339|NCT02679053|"     The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as     adon treatment for moderately to severely depressed inpatients. Endpoints are symptom     severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal     axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV).      Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post     (+6weeks) in already existing blood samples.   "
46365|NCT02678715|"     This observer-blind crossover intervention study aims to determine the most effective type of     device as oral mouthguard in modified-Electroconvulsive Therapy (m-ECT) comparing three types     of devices: standard, prefabricated and manufactured in the dental laboratory.      Patients from the ECT Unit of Psychiatric Department of the University Hospital of Bellvitge     will use the three devices at a random sequence during the twelve treatment sessions, so each     device (A, B, C) will be used for two weeks, that is, for four consecutive sessions.   "
46918|NCT02671487|"     The purpose of this study is to determine whether war-traumatize male adolescents with     behavioral and emotional problems who participate in mind-body skills groups will have     improvement in behavioral and emotional problems, aggression, and posttraumatic stress     disorder (PTSD) symptoms, compared to a wait list control group.   "
46340|NCT02679040|"     At present, it is widely admitted not proposing immediate mammary reconstruction when an     adjuvant radiotherapy is indicated because of the significant change of the cosmetic result     (profit) and it whatever is the technique of reconstruction adopted. This is true all the     more as it is about a reconstruction by prosthesis because of the prothetic died risk of     hull(shell).      Teams proposed immediate mammary reconstructions to expanding (carrier) patients of carcinoma     infiltrating, sometimes locally moved forward. For these patients, was not brought     back(reported) by increase of the risk of local or remote relapse.      Two studies estimated afterward the feasibility of the mastectomy with immediate mammary     reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of     morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar     to the patients benefiting from the classic therapeutic plan.      During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is     possible and that by prescribing the chemotherapy and the radiotherapy before immediate     mammary reconstruction, the morbidity is acceptable.      It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative     chemotherapy as regards the global survival.      On the other hand, the rate of histological answer, according to subgroups, is very     different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-,     Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.      The purpose of the investigators study is to estimate the rate of histological response     during the inversion of therapeutic sequence to make sure of the oncologic safety(security),     in particular by molecular subgroups, considering the heterogeneousness of the     results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier Classifications     is the references and will be used here, but the investigators can also use Symmans     classification in addition.      The rate of local and metastatic second offenses(recurrences) will also be estimated.   "
46341|NCT02679027|"     Objectives: The aim of study is to determine the possible usage of tongue movements out of     the mouth in the prediction of difficult intubation.      Method: Two hundred twenty three patients undergoing abdominal surgery with general     anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was     evaluated using the intubation difficulty scale (IDS) score. All intubations were performed     by anesthesiologist to eliminate the differences among the anesthesiologists' experiences.     IDS score were evaluated by anesthesiologists who had no idea about the measurements of the     tongue movements and performed laryngeal intubation in all patients.      To define the tongue movements, horizontal lines were used. Horizontal line were passing     through the mid points of mandible and upper lip height. Patients were asked to protrude     tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in     anatomical neutral position which was sitting down on a chair.   "
46342|NCT02679014|"     A randomized, double-blind, placebo-controlled, two treatment, parallel group study to     investigate the effects of RO5459072, a cathepsin S inhibitor, on the immune response to a     gluten challenge in volunteers with celiac disease. Volunteers with previously diagnosed     celiac disease will be randomized to receive either 100 milligrams (mg) RO5459072 or placebo     twice daily with food for 28 days (Days 1 to 28).   "
46343|NCT02679001|"     This six months non-interventional, observational, post-marketing, multi-center and local     study will evaluate the differences in the use of corticosteroids between RA participants     receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a     TNF-inhibitor as their first biological treatment.   "
46344|NCT02678988|"     The study consists of an eligibility screening period, two study periods involving single     doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover     design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy     participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled     syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The     total duration of the study is up to 16 weeks from screening to follow-up. After screening,     eligible participants will be randomly assigned to one of the two possible treatment     sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by     AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper     arm). All participant groups will receive a total of two TCZ administrations each.   "
46345|NCT02678975|"     Disulfiram (Antabuse®) is a well-tolerated, cheap, generic drug that has been in use since     the 1950s to treat alcoholism. There is now an increasing amount of independent preclinical     data to support disulfiram as an anticancer agent. The potency of disulfiram as an anticancer     agent seems strengthened by copper.      The investigators aim is to investigate disulfiram and copper-supplement as add-on treatment     in glioblastoma patients with recurrence receiving alkylating chemotherapy.   "
46346|NCT02678962|"     The purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of     Multifocal Intraocular Lenses: SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART, LS-313     MF30T.   "
46347|NCT02678949|"     The multiple breath washout (MBW) is one of pulmonary function test that displays flow and     gas concentration plotted against time, and shows an exponential decay in end-tidal gas     concentration (washout curve). A number of of indices to describe the washout curve have been     proposed, the most commonly reported is the Lung Clearance Index (LCI). This is a simple     measure of ventilation heterogeneity derived from MBW, that can be used after challenge with     a short action bronchodilator and in response to inhaled steroids, both in the conductive     airways as acinar. Patients with moderate and severe asthma are characterized by an     abnormality in both, conductive and the acinar airway. Therefore the following research     question could be: what are the abnormalities in the heterogeneity of ventilation in children     with mild and moderate asthma, with respect to the healthy population measured by MBW, and     whether these alterations persist after challenge with inhaled steroids and B2 agonists     short-acting.   "
46348|NCT02678936|"     Anal fistula is a very common disease with a high impact on life quality. The only commonly     accepted treatment option is surgery. A wide range of operations and techniques have been     developed all suffering from a relatively high recurrence rate.      The investigators propose the combination of the mucosal advancement flap with application of     platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis     that by applying PRP the healing rate of complicated anal fistulas can be improved in     comparison to a control group where the operation is performed without addition of PRP.   "
46349|NCT02678923|"     This study will be a proof-of-concept, placebo-controlled, double-blind, randomized trial in     participants with a recent acute coronary syndrome (ACS) to evaluate the efficacy,     pharmacokinetics, safety, tolerability, disease progression measures by IVUS, and     pharmacodynamics of MDCO-216 infusion. Eligible participants will be randomized to receive 5     infusions of MDCO-216 20 milligrams/kilogram (mg/kg) or placebo in a 1:1 ratio.   "
46385|NCT02678455|"     The purpose of this study is to evaluate the safety and immunogenicity of the recombinant     live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in     healthy adults, adolescents, and children in Dhaka, Bangladesh.   "
46350|NCT02678910|"     The purpose of this research is to obtain ovarian tissue from female participants who will     receive therapy which is expected to result in a loss or impairment of ovarian function     and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating     a pregnancy in the future.      Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue     will be used for the participant's future use. There have been 86 pregnancies as a result of     frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function     has been restored in individuals for up to 7 years.      By doing this study, the investigators hope to learn of how to successfully freeze and thaw     ovarian tissue in a manner that permits subsequent use by patients at some point in the     future. Participation may also advance our knowledge of how to successfully mature follicles     and oocytes (eggs) that are contained in these tissues which may help others in the future.   "
46351|NCT02678897|"     The study is two-parted. First part's aim is to map need of pain medication among patients     undergoing medical abortion in early pregnancy (under 9 pregnancy weeks). In second part     investigators compare different administration routes of opiates in patients in medical     abortion with pregnancy weeks 12-20. In both parts plan is to compare teenaged to adult women     and in addition to try to map predicting factors of severe pain.   "
46352|NCT02678884|"     The purpose of this study is to see how useful the information provided from Positron     Emission Tomography (PET) scans can be in the actual planning and delivery of radiation     treatment to patients who have head and neck cancers. Patients participating in this study,     will have (in addition to their routine tests) a PET scan before and during their radiation     treatment. Following the intervention, patients will be followed as per standard practice.   "
46353|NCT02678871|"     Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter     aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for     the prevention of ischemic stroke is very challenging in this population of complex and frail     subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHAMN device     proved promising safety and efficacy results in randomized comparisons with OAC (current     standard of care), the aim of the current study is to assess the feasibility and the early     safety of performing TAVI with the Lotus System and percutaneous LAA closure with the     WATCHMAN device at the same session.   "
46354|NCT02678858|"     The ISST study investigates whether integrated social cognitive remediation and social     behavioral skills therapy is more efficacious in improving functional outcome and treatment     adherence than an active control treatment comprising drill-and-practice oriented     neurocognitive remediation.   "
46355|NCT02678845|"     The purpose of this study is to determine whether treatment of patients with depression     according to the Collabri Model is more effective in reducing symptoms compared to treatment     as usual (TAU)   "
46356|NCT02678832|"     The study, investigates the current physical activity promotion practices among physicians     and nurses, as well as social norms toward physical activity during treatment among cancer     patients and among physicians and nurses who treat or counsel cancer patients.      For this purpose, four large surveys with health care professionals (specialized     practitioners, N=300; general practitioners, N=300; oncology nurses, N=300) and cancer     patients (N=1200, 400 patients each with breast, prostate or colorectal cancer) with a     cross-sectional research design are conducted.      Additionally, a follow-up-study with a sub-sample of cancer patients (N=180) will be     conducted.   "
46357|NCT02678819|"     The purpose of this study is to determine whether a wearable digital cognitive aid has an     effect in the management of simulated crises in anesthesia or intensive care.   "
46358|NCT02678806|"     Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but     the five-year relative survival rate is relatively quite low1-3. For hepatocellular carcinoma     treatment, current options are surgical resection, embolization chemotherapy, radiation     therapy, a variety of ablation therapy, biological and gene therapy, etc. Among them, the use     of radiation therapy is getting more and more attention, and it is changing from the past     palliative treatment to current curable treatment. From an oncologic point of view, a narrow     margin <1 cm and microvascular invasion is not safe and is often associated with higher rates     of recurrence and shorter patient survival.On the other hand, it is also believed that most     intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the     resection margin. To address this issue, the investigators are going to conduct a series of     retrospective and prospective studies to investigate the effect of adjuvant Radiotherapy for     centrally located hepatocellular carcinoma after narrow margin (<1 cm) hepatectomy on tumor     recurrence.   "
46359|NCT02678793|"     Subjects who have completed study 4975-MN-202 will be eligible to receive open-label     treatment with CNTX-4975 200 µg in study 4975-MN-203 if they meet the inclusion/exclusion     criteria.   "
46360|NCT02678780|"     This is a prospective, international, multi-center, open label, stratified, exploratory phase     II study evaluating the efficacy and safety of lenvatinib in patients with     advanced/metastatic, neuroendocrine tumors of the pancreas after progression to a previous     targeted agent (cohort A) or gastrointestinal tract after progression to somatostatin     analogues (cohort B).   "
46361|NCT02678767|"     This project will investigate the ability of a novel MRI contrast agent to identify and     quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of     HIV-infected individuals.   "
46362|NCT02678754|"     This data collection Registry is a multi-center, observational outcomes Database designed to     collect data on the demographics, presentation, diagnosis, treatment, resource use, quality     of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for     treatment of solid tumor cancer.   "
46363|NCT02678741|"     Assess the safety and tumor response of utilizing an autologous tumor lysate,     particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care     (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.   "
46364|NCT02678728|"     Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress     in diverse clinical settings. The investigators aimed to investigate the lung protective     effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic     circulatory arrest, which is associated with systemic inflammatory response, and oxidative     stress.   "
46366|NCT02678702|"     Participants (N=48) are patients with major depression in an outpatient clinic for affective     disorders.      Participants are assessed with clinical interview, polysomnographic evaluation and screening     with Insomnia Severity Index (ISI), Dysfunctional Beliefs About Sleep-scale (DBAS), HAM-D17,     MINI and Sleep Diary pre and post treatment.      Participants are randomly assigned to either treatment as usual or CBT-I. The latter receives     individual as well as group therapy with CBT-I during 6 sessions.      Post-treatment: The investigators will compare changes in polysomnographic measures, sleep     diary parameters, HamD17, ISI and DBAS. Data are analyzed by using Chi-square test,     Wilcoxon-Mann-Whitney U-test and ANOVA. STATA is used for data-processing.   "
46367|NCT02678689|"     This Phase 2 open-label, multicenter study will evaluate the safety, tolerability, and     efficacy of BMN 190 intracerebroventricular (ICV) administration every other week (qow) for a     period of 96 weeks, in patients with CLN2. The study is designed to assess disease     progression in CLN2 patients treated with BMN 190 compared to natural history data from     untreated historical controls.   "
46368|NCT02678676|"     The purpose of this study was to investigate the mortality and macrovascular morbidity as     well as the incidence of malignancies over time, in high-risk diabetic participants who     previously received long-term treatment with either pioglitazone or placebo in combination     with their usual medication for glycaemic management.   "
46369|NCT02678663|"     Complete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may     arise as a consequence of incomplete polypectomy. However, the ideal method to remove small     colorectal polyps remains uncertain. The investigators designed a randomized controlled trial     to assess whether injection-assisted cold snare polypectomy may be noninferior to EMR for the     resection of small (6-10mm) colorectal polyps.   "
46370|NCT02678650|"     It has been reported that volatile anesthetics preconditioning mediates protection of organ     via microRNA. We want to study on the effects of isoflurane preconditioning on expression of     microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.   "
46371|NCT02678637|"     Mitochondrial disorders are a group of inherited disorders causing malfunctional     mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore     give symptoms from every tissue, especially those with high energy needs as the brain, heart     and muscles. The disorders are highly disabling.      The aim of the study is to investigate the relation between muscle strength and contractile     cross sectional area (CCSA) in the leg of patients affected by mitochondrial diseases. The     hypothesis is that there can be a disrupted relationship between strength and CCSA.   "
46372|NCT02678624|"     The purpose of this study is to determine whether treatment of patients with anxiety     according to the Collabri Model is more effective in reducing symptoms compared to treatment     as usual (TAU)   "
46373|NCT02678611|"     This study will investigate the safety, tolerability and potential health benefits of the     dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third     of subjects will receive the low dose Basis, one third will receive the higher dose Basis and     one third will receive placebo.   "
46374|NCT02678598|"     The objective of this study is to evaluate the efficacy of intravenous micafungin for the     empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal     therapy or targeted antifungal therapy patients with invasive fungal infections caused by     Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in     adult patients in China.   "
46375|NCT02678585|"     The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia   "
46376|NCT02678572|"     This study will evaluate two groups of patients who have melanoma that has spread from the     eye to the liver: one group (50%) will get high-dose chemotherapy delivered specifically to     the liver, while the other group (50%) will get one of 4 standard best alternative care     treatments. Patients in each group will get repeating cycles of treatment until the cancer in     the liver advances and will be followed until death. This study will evaluate the effect of     the treatments on how long patients live and how long it takes for the cancer to advance or     respond to the treatment.   "
46377|NCT02678559|"     The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke     volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations     will be measured on preload dependency or preload independency status. The principal purpose     is to determine if variations of stroke volume during standardized ARM can predict the     preload dependency status.   "
46378|NCT02678546|"     Several questionnaires have been developed for clinical research in Traditional Chinese     Medicine. The objective of this study is to evaluate the consistency and relevance of two     questionnaires, the Constitution in Chinese Medicine Questionnaire (CCMQ) and the Body     Constitutions Questionnaire (BCQ).   "
46379|NCT02678533|"     The purpose of this study is to assess the feasibility of Plerixafor used in combination with     G-CSF (Granulocyte Colony Stimulating Factor) in 5 Fanconi anemia patients to mobilize and     collect a sufficient number of peripheral blood CD34+ cells for peripheral blood apheresis,     for further gene therapy study.   "
46380|NCT02678520|"     Compare the incidence of acute rectal, bladder and other acute toxicities between 3-D     Conformal Radiation Therapy (RT/CRT) and Intensity Modulated Radiation Therapy (IMRT) in     Post-Prostatectomy Prostate Cancer Patients treated with post-operative radiation therapy   "
46381|NCT02678507|"     The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to     identify opioid abuse and misuse behaviors among participants who have chronic pain which     requires long-term opioid use.   "
46382|NCT02678494|"     A study examining the effectiveness of neurofeedback therapy for the treatment of Central     Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly     device which can be operated by patients at home.   "
46383|NCT02678481|"     To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy     and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least     one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR     scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be     randomized (1:1) into the two study arms.   "
46384|NCT02678468|"     To evaluate the effect of early vision screening with automated photorefraction device in     high risk children   "
46386|NCT02678442|"     This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue     from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and     cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional     Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in     which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.   "
46387|NCT02678429|"     Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time     intensive process. Using an atlas created using functional tremor responses in the operating     room to determine the optimal settings would lead to a faster response for the patient and     improved quality of life.   "
46388|NCT02678416|"     Compare reduction in pain intensity provided by IV or oral acetaminophen using UVB pain model   "
46389|NCT02678403|"     Purpose: The investigators team recently carried out a proof of concept study testing the     efficacy of one single 45-minute session of 10 Hz TENS prior to walking, versus placebo. In     this randomized study, the investigators found that TENS significantly delayed pain onset and     increased the pain-free walking distance in patients with class II PAD. From these     encouraging results, the investigators now seek to assess the efficacy of an intervention     that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in PAD     (Leriche-Fontaine stage II). Methods/Design: prospective multicentre study / randomized     controlled trial / double blinding.   "
46390|NCT02678390|"     The aim of this study is to compare the effect on ketone production of dietary an MCT     supplement combined or not with physical exercise in two groups of women (N=10/group),     healthy adults and patients with prediabetes. After an evaluation of the metabolism (a 4-hour     visit with multiple blood samples) at the beginning of the study, all the participants are     taken for one-week the MCT supplement alone follow by a one-week period of taking the MCT     supplement in combination with physical exercise. At the end of each period of time, the     4-hour visit for the evaluation of the metabolism is repeated.   "
46391|NCT02678377|"     This double-blind randomized controlled trial seeks to find a better treatment for women with     mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to     determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA     (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary     incontinence better than sling surgery alone.   "
46392|NCT02678364|"     While there have been a considerable number of studies on the impact of additional vitamin D     in the diets of hens on the resulting egg vitamin D content, the effect of consumption of     such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been     tested in a RCT.   "
46394|NCT02678338|"     This phase I trial studies the side effects and best dose of anti-cluster of differentiation     (CD)47 monoclonal antibody Hu5F9-G4 in treating patients with haematological malignancies     including acute myeloid leukemia that has returned after a period of improvement (relapsed)     or has not responded to previous treatment (refractory), or high risk myelodysplastic     syndrome. Monoclonal antibodies, such as anti-CD47 monoclonal antibody Hu5F9-G4, block cancer     growth in different ways by targeting certain cells.   "
46395|NCT02678325|"     The objective of this study is to compare the difference in daily protein intake of     critically ill patients in two standardized enteral nutrition formulas (20% versus 33%     percent) with the same caloric density of 1.2 kcal/ml.      The total amount of protein taken in on day four after starting the early enteral feeding is     defined as primary endpoint.   "
46396|NCT02678312|"     This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the     way the body absorbs, distributes and removes the drug LCZ696. This will help determine the     proper dose of LCZ696 for Part 2 of the study.      The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in     pediatric heart failure patients over 52 weeks of treatment.   "
46397|NCT02678299|"     This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in     combination with bendamsutine, etoposide and , for CD20 positive B-cell lymphomas, rituximab     (P[R]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.   "
46398|NCT02678286|"     The primary objective of this study is to evaluate the analgesic efficacy of N1539 in     subjects with acute moderate to severe pain following abdominoplasty surgery.   "
46399|NCT02678273|"     The investigators will provide an integrated community of care to a socioeconomically     disadvantaged population. This included an extended cycle of care from tertiary care to     primary care and linkages with social care agencies in the community.   "
46400|NCT02678260|"     The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK),     and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to     Japanese patients.   "
46401|NCT02678247|"     The overall objective of this study is to provide a more comfortable and functional     prosthetic socket for persons with transfemoral amputation that will ultimately improve their     quality of life.   "
46402|NCT02678234|"     The purpose of the study is to assess the short term efficacy of the Theraflu Aktiv powder     for oral solution in the Russian population as compared to an untreated group to support the     indication of Short term relief of the symptoms of colds, chills and influenza, including     mild to moderate pain, fever and nasal congestion.   "
46423|NCT02677961|"     Translational studies in cancer research can be impeded by the lack of high-quality clinical     data that can be correlated with research questions. This is particularly true in the case of     rare diseases, such as bone and soft tissue tumors. It is therefore the purpose of this study     to create a prospective EHR-based clinical registry for individuals with bone and soft-tissue     tumors.   "
46432|NCT02677844|"     The purposes of this study are to determine:        -  The effect of single increasing doses of the study drug, abemaciclib, on healthy          participants.        -  The relationship between the amount of abemaciclib and the electrical tracing of the          heart rhythm when abemaciclib is given.        -  How much abemaciclib is found in the bloodstream and how long the body takes to get rid          of it.      Information about any side effects that occur will be collected. The study will enroll two     groups (cohorts) of participants. Each group will complete 4 study periods. This study is     expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All     participants will undergo a follow-up assessment approximately 21 days after administration     of their final dose of study drug.   "
46403|NCT02678221|"     Intrauterine growth restriction (IUGR) is defined as fetal abdominal circumference (AC) or     estimated fetal weight (EFW) < 10th centile. In asymmetrical IUGR the parameter classically     affected is the abdominal circumference (AC). Fetal growth restriction (FGR) complicates     approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and     mortality. This is particularly due to premature delivery, both for fetal and for secondary     maternal indications such as the development of pre-eclampsia.      Consequence of deficient uteroplacental blood flow, including IUGR, pre-eclampsia, and     placental abruption have been implicated in more than 50% of iatrogenic premature births. For     this reason, the problem of severe IUGR forms a substantial portion of the population that     tertiary care centres care for.      The effect of early-onset IUGR is particularly significant: of those born alive, less than a     third will survive their neonatal intensive care unit (NICU) stay without significant     neurodevelopmental sequelae. Survival rates for severely growth-restricted fetuses very     remote from term (<28 weeks' gestation) vary from 7% to 33%.      As these early-onset IUGR children are born very preterm, there are significant risks of     neonatal mortality, major and minor morbidity, and long-term health sequelae.      The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests     compromised uteroplacental circulation and placental hypoperfusion. Currently there are no     specific evidence-based therapies for placental insufficiency and severe IUGR. Non-specific     interventions include primarily lifestyle modifications, such as reducing or stopping work,     stopping aerobic exercise, rest at home, and hospital admission for rest and surveillance.     These interventions, which are not supported by evidence from randomized trials, are used in     the belief that rest will enhance the uteroplacental circulation at the expense of that to     the glutei and quadriceps muscles.      There is evidence from ex vivo and animal models of growth restriction that the     phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves     uteroplacental blood flow (umbilical artery, uterine artery).   "
46404|NCT02678208|"     Postpartum hemorrhage is the most common cause of maternal death across the world,     responsible for more than 25% of maternal deaths annually. Although effective tools for     prevention and treatment of are available, most are not feasible or practical for use in the     developing world where many births still occur at home with untrained birth attendants .     primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24     hours of delivery of the fetus which affects the general condition.      Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide ,     reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of     long-term severe morbidity, and approximately 12% of women who survive postpartum     hemorrhagewill have severe anemia.      Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of     the activation of plasminogen to plasmin. At much higher concentrations it is a     non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen     activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times     greater than that of aminocaproic acid.   "
46405|NCT02678195|"     This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in     children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and     then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.   "
46406|NCT02678182|"     To evaluate the efficacy of maintenance therapies following completion of standard first-line     chemotherapy in patients with locally advanced or metastatic HER-2 positive or HER-2 negative     oesophago-gastric adenocarcinomas.   "
46407|NCT02678169|"     Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters     and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from     symptom onset with an acute ischemic stroke (within the internal carotid artery and internal     carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel     occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first     intention and site routine practice.   "
46408|NCT02678156|"     The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the     performance of Lyoplant® Onlay. To assess the performance of the product, various safety and     efficacy parameters have been selected.   "
46409|NCT02678143|"     The aim of this study is to evaluate the overall safety and feasibility of using     haploidentical or one antigen mismatch unrelated hematopoietic stem cell transplant (HSCT)     for adult patients with severe sickle cell disease (SCD) who undergo a non-myeloablative     preparative regimen consisting of total body irradiation (TBI), cyclophosphamide and     alemtuzumab and graft vs. host disease (GvHD) prophylaxis consisting of post-transplant     cyclophosphamide (PT-Cy), mycophenolate mofetil (MMF), and sirolimus. The investigators     anticipate that this approach will expand the donor pool and offer a safe and less toxic     curative intervention.   "
46410|NCT02678130|"     The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar     interbody device is at least equal in safety and efficacy to other (standard of care) TLIF     devices.   "
46412|NCT02678104|"     A prospective randomized parallel trial will be carried out on 100 patients who have     extraction of single molar tooth. Teeth extractions will be done under local anesthesia. The     patients will be divided randomly into two parallel groups. Group 1: The patients will start     using Chlorhexidine mouthwash on the second day of extraction twice daily for 7 days. Group     2: After extraction, Manuka Honey will be applied topically into the extraction socket.     Postoperative instructions will be given for all patients in addition to the prescription of     ibuprofen 600 mg every 8 hours for 3 days.      Re-evaluation:      Postoperative day 3: tenderness with probing the socket, empty socket, food debris, halitosis     and assessment of pain. For group 2, the intra-alveolar application of honey will be     repeated. Re-evaluation will be repeated in the seventh post-operative day. Acute alveolar     osteitis, (dry socket) is diagnosed if the patient presented between the 2nd and 4th days     with pain or tenderness in the socket with probing, empty socket and food debris with or     without halitosis.   "
46446|NCT02677662|"     Air pollution continues to be a key global issue with many governments focusing great     attention on air quality legislation because of its harmful environmental and health impacts.     Whilst there is much that remains unknown about the mechanisms underlying the negative health     effects of air pollution, it is generally acknowledged that air pollution exposure leads to     an increase in cardiovascular, cerebrovascular and respiratory mortality and morbidity. The     current study will investigate systemic effects during a 72 hour period after a controlled     diesel exhaust exposure.   "
46433|NCT02677831|"     The general aim of this study is to establish a longitudinal cohort of older persons in order     to examine the physiological, environmental and genetic risk factors for physical disability,     frailty, cardiovascular disease, and neuropsychiatric disorders in older persons and to     examine the benefit of healthy lifestyles. The findings from this study will provide     information necessary for the development of effective health policy for aging people.   "
46434|NCT02677818|"     The purpose of this study is to determine whether Plasma Factor VIII Levels are related to     the treatment of bleeding in ischemic stroke（IS）.   "
46413|NCT02678091|"     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid     structures or vascular structures. These masses can be tumors, benign or malignant, or     pseudotumor, mainly represented by specific or non-specific orbital inflammation.      Pathology is of considerable importance for the diagnosis and the treatment of those masses.     However, biopsy or surgical resection of the orbital masses is sometimes difficult and     dangerous outside expert centers.      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,     thus avoid in some cases a biopsy, would be a major contribution for the patients.      Quantitative analysis of the ultrasound exam with doppler of those masses could identify     diagnostic criteria, especially for the lacrimal gland, easily explorable.   "
46414|NCT02678078|"     Characterization of Cancer Tissue Using 3D Biosynthetic Materials. Using liver biopsy from     stage 4 cancer patients, the investigators will evaluate and characterize the metastatic     cells.   "
46415|NCT02678065|"     The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for the     treatment of popliteal lesions in comparison with literature results of stent treatment in     popliteal lesions   "
46416|NCT02678052|"     The purpose of this study is to assess the prevalence of major structural birth defects in     infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed     to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other     biologic agents.   "
46417|NCT02678039|"     This is a prospective, randomized, controlled, and single blinded study. All work performed     at Dartmouth-Hitchcock Medical Center, a tertiary care and level one trauma center for the     state of New Hampshire with 28 operative suites. 100 patients scheduled to undergo     thoracotomies are randomized to receive an epidural placed (for postoperative pain control)     using either a traditional approach by feeling the spine for landmarks or using fluoroscopic     X-ray guidance. Randomization is blinded to both the anesthesia team caring for the patient     in the operating room and to one member of the acute pain team who follows the patient after     surgery and is responsible for evaluating post operative pain control (dermatomal     distribution of sensory blockade and visual analog scale) and pulmonary function (incentive     spirometer use). All patients receive a standardized epidural infusion with local anesthetic     and additional pain medications as needed.   "
46418|NCT02678026|"     Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB)     who developed a dilated cervix detected by manual exam in the second trimester. In     contemporary practice, there are three possible indications for cerclage. History-indicated     cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on     poor prior obstetrical history, e.g. multiple second trimester losses due to painless     dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually     between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) < 25mm in a woman     with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually     between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on     physical (manual) examination.      Randomized trials and meta-analysis of these have shown that UIC is associated with     significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for     history-indicated cerclage and physical exam-indicated cerclage is limited. In the United     States, the national data shows that the rate of cerclage has decreased in the last few     years. The indications of placement of cerclage have recently changed, and so it is important     to evaluate how many women are getting this procedure. With the recent completion of clinical     trials, it is plausible that obstetricians and perinatologists may have become more selective     in terms of the best candidates for cerclage.      The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as     adjuctive therapy in women with UIC   "
46419|NCT02678013|"     Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of     cancer-related death worldwide. Recurrence of tumor within the liver remnant is common, with     a reported 5-year recurrence rate of 70%. Repeat hepatectomy is an effective treatment for     intrahepatic HCC but with a small proportion of resection rate because of the poor functional     liver reserve and postoperative complications. Radiofrequency ablation(RFA) is becoming the     main effective treatment for small HCC (≤5.0cm). The efficacy of RFA for recurrent HCC has     been reported to be comparable to those achieved by surgery with minimal, but higher local     recurrence rate after RFA. It has been reported that immunotherapy in patients who underwent     curative treatment for HCC, adjuvant immunotherapy with activated CIK cells increased     recurrence-free and overall survival. But there is little evidence for adjuvant immunotherapy     of recurrence HCC. Cytotoxic T lymphocytes(CTL), a kind of effective T cells that specific     recognizing and killing antigen targeted cells through cloning amplification after receiving     antigen information from antigen presented cell and playing key role to clear cancerous     cells. So our hypothesis is that RFA combined with immunotherapy (Highly-purified CTL) is     superior to RFA for recurrent HCC. The aim of this prospective study is to compare the     outcome of RFA combined with immunotherapy (Highly-purified CTL) with RFA for small recurrent     HCC after partial hepatectomy.   "
46420|NCT02678000|"     This is a randomized, double-blind, parallel group, placebo-controlled study, in two     sequential parts to evaluate the renal safety, tolerability and pharmacokinetics of LHW090 in     patients with moderately impaired renal function.   "
46421|NCT02677987|"     Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere     with quality of life and can linger long after treatment has ended, yet research examining     cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study     will provide information about systematic light exposure for the treatment of cognitive     impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it     works. This study would facilitate the development of this potential treatment, giving health     care providers and cancer survivors a much-needed tool to help with cancer-related cognitive     impairment.   "
46422|NCT02677974|"     The purpose of the proposed study is to assess the occurrence of bleeding, valve-related     thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when     targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a     5-year follow-up period. The objective will be to compare adverse event rates for patients in     subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to     rates from the previous IDE trial (G050208).   "
46424|NCT02677948|"     This study combines two drugs in the treatment of relapsed/refractory chronic lymphocytic     leukemia (CLL) and small lymphocytic lymphoma (SLL). Investigators are proposing combining     ibrutinib, an orally-administered, small molecule inhibitor of Bruton's tyrosine kinase (FDA     approved for the treatment of relapsed/refractory CLL), with pacritinib, a novel JAK2-FLT3     inhibitor that has shown activity in relapsed lymphoma, including CLL/SLL. Investigators will     first demonstrate the safety and tolerability of Pacritinib when combined with Ibrutinib in a     phase I study, which will help establish the MTD (Maximum Tolerated Dose)of Pacritinib when     combined with Ibrutinib. Once the optimal dose of Pacritinib is established in the phase I     setting, a phase II evaluation will seek to establish the efficacy of the combination of     Pacritinib with Ibrutinib. Patients will receive continuous treatment until progressive     disease and will be followed while on study treatment for a total of 2 years.   "
46425|NCT02677935|"     Worldwide, headache disorders are among the most common medical conditions. Many people with     headache need not experience further pain if the diagnosis and treatment are correct. Most     patients do not have correct diagnosis and treatment. This study tested a model for treatment     of people with headache disorders at primary health-care level in rural areas of Haryana,     India.   "
46426|NCT02677922|"     This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety     and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine     in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The     study population consists of subjects who are not candidates to receive intensive Inductive     chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage and     a Phase 2 randomized stage.   "
46427|NCT02677909|"     In this study, the investigators aim to conduct a pilot test of the AbStats device. The v2.0     prototype is a low-profile set of sensors that fits externally around the abdomen and is     embedded with specialized wireless sensors. The device continuously, safely, and comfortably     monitors intraabdominal acoustic signals, and stores the data in a HIPAA compliant software     system.      The investigators will focus this trial on a high-impact inpatient population: ileus in the     surgical critical care unit. The investigators will compare the device's signal profiles in     patients with ileus vs those who tolerate feeding without high gastric feed residual. Our     study will have the following specific aims:      Specific Aim #1: To measure the sensitivity, specificity, positive predictive value (PPV),     and negative predictive value (NPV) of initiation day (PID 0) AGIS signals in predicting     PID #1 feeding failure. Specific Aim #2: Among patients tolerating feeds on PID #1, to     measure the sensitivity, specificity, PPV, and NPV of AGIS in predicting feeding failure on     subsequent icu days.   "
46428|NCT02677896|"     The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen     deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based     on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.   "
46429|NCT02677883|"     This randomized controlled trial attempts to determine whether the measurement of pleural     pressures during therapeutic thoracentesis affects the development of chest discomfort after     the procedure. During thoracentesis, pleural fluid is drained from the pleural space,     resulting in lung expansion. In some cases, the lung is not completely re-expandable, in     which case continued drainage results in the development of negative pleural pressures and     chest discomfort. Negative pleural pressures may also result in other complications such as     re-expansion pulmonary edema and pneumothorax. The identification of negative pleural     pressures via manometry during the procedure may lead to a reduction in the complication     rate.   "
46430|NCT02677870|"     The purpose of this study is to determine if Amish patients with PKU show responsiveness     after a high dose, prolonged Saproterin trial. The population of interest has a high     frequency of a specific splice site mutation, the 1066-11G>A mutation. This splice site     mutation activates a cryptic splice site resulting in an in frame insertion of 9 nucleotides     preceding exon 11. This leads to protein conformational changes and abrogation of function.     Previous studies of this genotype have indicated <1% residual activity of the PAH enzyme and     an insignificant responsiveness to Saproterin. However, in this specific study Phe levels     were evaluated only over 24 hours after a single-dose BH4 challenge at the standard dose of     20mg/kg.      Based on new clinical information, the investigators hypothesize that if given a prolonged     trial of Saproterin at a higher dose, Amish patients with PKU, specifically those homozygous     for the c.1066-11G>A mutation, will have a significant reduction in Phe levels or an increase     in Phe tolerance and/or improvement in executive functioning and quality of life.   "
46431|NCT02677857|"     At this time, no study has examined the effect of a lifestyle intervention with a reduced     Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic     dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with     University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to     randomize 30 female breast cancer survivors (history of breast cancer stages I [> 1 cm], II,     or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in > 8     hours a day of SB) and inactive (engage in < 100 min/wk MVPA) to one of three, 3-month     conditions:        1. lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk);        2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to >          200 min/wk and reduce SB by 2 hrs/day); or        3. weight management education materials provided via mailed newsletter (Newsletter).      Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie [1200-1500 kcal/day],     low-fat [<30% calories from fat]) prescription that emphasizes intake of fruits, vegetables,     and whole grains, and a cognitive behavioral intervention to assist with meeting activity and     diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB,     LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss;     insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis     that have been found to be positively related to SB and/or adiposity); diet; body     composition; and fitness.   "
46480|NCT02677220|"     The aim of this study is to investigate the clinical benefit for patients implanted with the     Nucleus® CI532 cochlear implant.      The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into     the cochlea through a straightening sheath.   "
46436|NCT02677792|"     The purpose of the current study is examine the feasibility and efficacy of providing a     behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending     a multidisciplinary pediatric obesity clinic and their parents. Participating families will     complete assessments consisting of weight status, dietary intake, physical activity,     health-related quality of life, psychological functioning, home-food environment, parenting     skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month     post-treatment follow-up (Month 5). Family attendance data will be collected during the     behavioral family intervention and children and parents will complete a treatment     satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C,     glucose) routinely assessed through standard medical care in the multidisciplinary pediatric     obesity clinic will be obtained from child medical charts.   "
46437|NCT02677779|"     The study is aimed at comparing debridement either with CO2 laser or traditional surgery in     patients with infected diabetic foot ulcers. The principal endpoint is bacterial load     immediately after treatment.   "
46438|NCT02677766|"     To date, there are no studies that demonstrate that the intervention of Occupational Therapy     (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical     and functional outcome for the patient. For this reason, the investigators propose one     randomized controlled trial that will compare the group receiving the intervention of OT and     the control group, to quantify the level of performance and satisfaction in the activities of     interest of the patient, identified through the COPM. The hypothesis is that the benefit may     be higher, as clinically relevant, in the group of complex patients treated with the proposed     intervention of OT compared to those receiving the usual rehabilitation therapy.   "
46439|NCT02677753|"     The investigators propose a randomized control trial comparing the rate of implantation of     the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without     fluoroscopic guidance.   "
46441|NCT02677727|"     This is a prospective observational study investigating the incidence, characteristics of,     and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20     instrument. Approximately 60 patients will be collected for this study. The duration of this     study will be up to 18 months for each patient. This study will complement a current R01     funded trial (Platinum Study) which evaluates the genetic predisposition of chronic     neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a     similar patient population, it does not evaluate the natural history of platinum induced     neuropathy during active treatment and the first 12 months post chemotherapy. This trial will     fill this gap and add to the investigators knowledge for both natural history and genetic     predisposition of platinum neurotoxicity.   "
46442|NCT02677714|"     The changes to the heart can be evaluated during the course of the chemotherapy with cardiac     magnetic resonance imaging (CMRI) and left ventricular (LV) nuclear scans to look at left     ventricular ejection fraction (LVEF). Serial LVEF evaluation can detect cardiotoxicity,     usually after cardiac damage is present and most likely irreversible. Each patient's     sensitivity to the chemotherapy is different.      The study is being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to     image the cell damage from apoptosis, or cell death, in the heart from the effects of the     chemotherapy. This may allow doctors to identify patients developing cardiotoxicity in the     future. These patients may then benefit from changes in chemotherapy with dose alterations or     changes to alternative drugs.   "
46443|NCT02677701|"     This is a study to examine the effect of combining chronic oral azithromycin with inhaled     tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected     with P. aeruginosa.   "
46444|NCT02677688|"     EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective     control in EBV infection and altered both B and T immune responses to this virus The main     objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of     autologous EBV specific CTL adoptive transfer in adult patients with serologically active SLE   "
46445|NCT02677675|"     The objective of this study was to determine the effectiveness of mobile phone technology     (SMS and telephone call reminders) in improving adherence and treatment outcomes among HIV     positive patients on ART in Malaysia.   "
46481|NCT02677207|"     To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric     performance and residual depressive symptoms in patients who have been diagnosed with     unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major     Depression or Manic Episode.   "
46447|NCT02677649|"     Composition and diversity of intestinal microbiota that are subject to the influence of diet     have a significant impact on health in the gut and whole body via complex interactions     between food constituents, bacteria, and host. Polyphenols are poorly absorbed in the upper     gastrointestinal tract and reach the colon, where they may have a reciprocal relationship     with microbiota. Because how polyphenols mediate gut health and reduce risk for other     pathogenesis remains to be elucidated, we propose to conduct a pilot controlled feeding study     to examine the impact of polyphenols and other constituents in the free dried whole cranberry     powder (FWCP) on composition and diversity of gut microbiota, as well as to substantiate     bioavailability of cranberry polyphenols. The central hypothesis underlying the proposed     research is that FWCP polyphenols will diminish the magnitude of a plant food free diet     induced increase in Alistipes, Bilophila and Bacteroides and will increase Enterococcus,     Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale groups. The     proposed research is novel as no study has examined the specific impact of FWCP polyphenols     incorporated into a plant food free diet on gut microbiota. This proposed study is innovative     because the positive results will demonstrate with a high degree of confidence that the     impact of FWCP constituents on production of beneficial short chain fatty acids, carcinogenic     bile acids, and atherogenic trimethylamine. The results generated from the study using a     plant food free dietary regimen as the background diet will provide definite proof on     microbial modulating actions of FWCP, inform mechanism of actions in urinary tract infection     (UTI), and be used to formulate messages in consumer communications for gut health.   "
46448|NCT02677636|"     This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3     study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up   "
46449|NCT02677623|"     Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to     identify the opening of the ureters to ensure that they are working correctly. Historically,     indigo carmine, an intravenous medication that dyes the urine blue, has been used to help     visualize the opening of the ureters with cystoscopy which is a camera placed inside the     bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus,     investigators need to evaluate other methods for assessing ureteral patency. Ideal     alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are     readily available and are easy to use.      Examples of such agents currently being used to evaluate the ureters, include oral pyridium,     IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by     either dyeing the urine a different color such as pyridium and sodium fluorescein, or by     having a different viscosity to urine such as mannitol. This study will compare three methods     of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium     fluorescein, and pyridium.   "
46450|NCT02677610|"     This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3     study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up.   "
46451|NCT02677597|"     Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal     Squamous Cell Carcinoma   "
46452|NCT02677584|"     Investigators hypothesized that the timing of caffeine administration in either prophylaxis     or treatment of apnea of prematurity will affect the apnea response to caffeine   "
46453|NCT02677571|"     Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic     option for major breast surgery.      102 patients undergoing reconstruction breast surgery will be randomized into two groups:     Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6)     performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.      Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if     pain > 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed     with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.      Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if     pain > 5/10 at rest      Primary Outcome Measures:      Morphine consumption (mg) (Time Frame: 24 hours) in two Groups      Secondary Outcome Measures:      Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the     first 24 hours postoperatively.      Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain     during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids     intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and     60.   "
46454|NCT02677558|"     The purpose of this study is to determine the impact of obesity in pregnancy on maternal     cardiac function. For this, morbidly obese term pregnant women (study group) and term     pregnant women of normal weight are assessed by transthoracic echocardiography.   "
46455|NCT02677545|"     Patients with symptomatic or asymptomatic carotid stenosis in whom carotid artery stenting is     planned are randomised between antiplatelet therapy with ticagrelor plus aspirin or     clopidogrel plus aspirin and examined with brain MRI before and after stent treatment. The     proportion of patients with new ischaemic lesions on MRI after treatment is compared between     the two groups.   "
46456|NCT02677532|"     The aim of the study is to determine wether continuous wound infusion with local anaesthetic     plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided     with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients     undergoing open abdominal aortic aneurism repair.   "
46482|NCT02677194|"     The aim of this study is to assess cutaneous healing process under LED exposition on 10     healthy subjects pre-treated with fractional CO2 laser on mini-zones on forearms.   "
46483|NCT02677181|"     The purpose of this study is to determine the efficacy and safety of combined ATG     （antithymocyte globulin ） regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in     matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).   "
46484|NCT02677168|"     The purpose of this study is to determine whether cNEP (continuous positive external     pressure) is effective in treating obstructive sleep apnea   "
46998|NCT02670447|"     Researchers propose in this project to evaluate predictive factors of non response. It is     defined by the lack of symptomatic remission at month 3, for patients presenting a first     episode of psychosis. It will be performed on objective markers taken from imagery     techniques. The link between evolution of these markers and clinical measures will be     studied.   "
46457|NCT02677519|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5     years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD).      Safety and tolerability will be evaluated by assessing treatment-emergent adverse events     (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The     primary objective of this study is to evaluate the long-term (12-month) safety and     tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed     with ADHD.      Safety and tolerability will be evaluated by assessing treatment-emergent adverse events     (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values     and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and     quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ).      Secondary objectives include assessment of long-term efficacy of Aptensio XR®.      Secondary measures include:        -  Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale          Preschool Version (ADHD-RS-IV Preschool Version)        -  Clinical Global Impressions-Severity Scale (CGI-S )        -  Connors Early Childhood Behavior-Parent Short form [Conners EC BEH-P(S)]   "
46458|NCT02677506|"     This study compares the infraclavicular approach to supraclavicular approach of brachial     plexus block for elbow surgery.   "
46459|NCT02677493|"     This study evaluates the immunogenicity and safety of 'IL-YANG Quadrivalent Influenza Vaccine     Inj.' in healthy male and female adults at the age of 19 or older.   "
46460|NCT02677480|"     The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥     4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9     used placebo tablets and gel. The salivary secretion rates were measured and microbial     samples collected and analysed using cultivation technique twice both at baseline and at the     3-month follow up (1-2 weeks between the appointments).   "
46461|NCT02677467|"     Investigators examine blood-pressure variance, several cardiovascular risk factors of patient     with epistaxis. As a result of collected data, investigators look into correlation between     epistaxis and hypertensive cardiovascular disorder.   "
46462|NCT02677454|"     To evaluate the accuracy of the Flash Glucose Monitoring system (FGM), Abbot FreeStyle Libre,     used today in clinical practice in Sweden in estimating plasma glucose levels. Data will be     collected in ambulatory patients with type 1 diabetes to determine safety, accuracy, and     reliability.   "
46463|NCT02677441|"     This study will evaluate the non-inferiority of conservative management for acromioclavicular     clavicle disjunction, compared with surgical management. Half of patients will be treated     with a specific standardized rehabilitation protocol, and the other half will be treated with     coracoclavicular and acromioclavicular fixation, followed by a another specific standardized     rehabilitation protocol.      Outcomes:      The primary outcome is the non-inferiority of the conservative management over surgical     management of Rockwood III-V Acute acromioclavicular joint dislocation (ACJD) without PICCAT     with American Shoulder and Elbow Surgeons (ASES score) at one year. If the non-inferiority is     reached, the non-inferiority of the conservative management over surgical the management of     Rockwood III-V ACJD with PICCAT using ASES score at one year will be evaluated.      Secondary outcomes were radiological criteria (i.e. comparison of ipsilateral and     contralateral coracoclavicular distance on anterior view; and dynamic posterior shaft of the     cross-body adduction Basamania/Alexander view) return to sports, work absenteeism,     complication rate, cosmetic results, patients satisfaction, Constant score, Single Assesment     Numeric Evaluation (SANE) score, Acromioclavicular Joint Instability (ACJI) score, ASES score     at others timepoints, and range of motion of the implicated shoulder. Finally, multivariable     regression analysis will be performed in order to evaluate the impact of predictors of     interest on ASES score at one year.   "
46464|NCT02677428|"     A significant portion of Veterans who apply for disability benefits have difficulty finding     and sustaining employment, and are concerned that working for pay will jeopardize their     receipt of service-connection benefits. In a completed clinical trial, Veterans who received     Motivational Interview-formatted counseled about opportunities to work and receive     service-connection went on to work for pay significantly more often than controls. The     proposed clinical trial will test this counseling's efficacy when it is delivered by an     automated computer program.   "
46465|NCT02677415|"     Recent observational studies have found an association between general anaesthesia and     increased post-operative mortality in acute ischemic stroke patients undergoing endovascular     treatment. It is unknown whether there is a causal relationship in this observation. The     investigators are performing a large randomised trial of general versus local anaesthesia to     definitively answer the question of whether anaesthetic type alters perioperative outcome.   "
46466|NCT02677402|"     Objectives In this study the investigators examined the changes in common femoral vein (CFV)     and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold     water immersion (CWI) and contrast water therapy (CWT).      Design Ten professional handball players visited the laboratory on three occasions. At each     visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air     (baseline) and then 16-minutes lower limbs TNI (~35°C), CWI (~12°C) or CWT (2:2minutes (~12°C     to ~35°C) ratio), selected randomly.      Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the     end of 16 min immersion.   "
46467|NCT02677389|"     This randomized pilot clinical trial studies how well survivorship care plan works in     promoting technology-based physical activity in breast or colorectal cancer survivors in     Wisconsin. A survivorship care plan may help doctors to better understand how they can help     people who have been diagnosed with cancer to become more physically active. It is not yet     known whether a standardized cancer survivor plan used as part of routine care or a     technology-based physical activity intervention is better in promoting physical activity in     breast or colorectal cancer survivors.   "
46468|NCT02677376|"     To determine the feasibility and success rate of tumor tissue procurement using     molecular-image-directed biopsies of responding and non-responding osseous metastases,     measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.   "
46999|NCT02670434|"     The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on     the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary     hyperlipidemia or mixed dyslipidemia   "
46469|NCT02677363|"     Strength training can increase muscle mass and strength while improving bone density and     reducing risk for osteoporosis and related fractures. Strength training can also lead to     reduced risk for diabetes, heart disease, arthritis, depression, and obesity; and improves     self-confidence, sleep and vitality. Research demonstrates that strength training is     extremely effective in helping aging adults with chronic conditions prevent further onset of     disease and, in many instances, actually reverse the disease process. In Stay Strong, Stay     Healthy Program elderly subjects perform resistance exercise training (RET) twice every week.     Past literature suggests that resistance training improved muscle activity, muscle strength,     muscle mass, and bone mineral density and total body composition, and adiponectin, insulin     sensitivity, fasting blood-glucose (BG), HbA1c1 (long-term marker of BG), blood pressure     (BP), blood triglycerides (TGs) and low density lipoproteins (LDL) in healthy and diabetic     subjects. The purpose of this study is to measure the changes in the above discussed     variables after 8-weeks of resistance exercises.   "
46470|NCT02677350|"     To evaluate the role of allogeneic mesenchymal stem cells for treatment of perianal     fistulizing Crohn disease.      Twenty (20) Crohn's disease patients with complex or multiple perianal or rectovaginal     fistulas will be included and will be scheduled to undergo peri-fistula injections after     meeting all inclusion/exclusion criteria's at baseline.      Following the Pilot Phase of four (4) subjects, sixteen (16) subjects are scheduled to     undergo perianal injections and after meeting all inclusion/exclusion criteria's, will be     evaluated at baseline.   "
46471|NCT02677337|"     This study will consist of three parts: 1) a retrospective chart review of patients treated     for mRCC from July 2013 until the start of the educational intervention; 2) an educational     program for DCN community oncology providers and DCN community patients with mRCC, lasting 8     - 10 months, and 3) a second retrospective chart review of patients treated for mRCC starting     at the time of the educational intervention until the intervention is completed.   "
46472|NCT02677324|"     This research study is studying a targeted therapy as a possible treatment for relapsed or     refractory Waldenstrom's Macroglobulinemia (WM). This study is using the study intervention     ABT-199.   "
46473|NCT02677311|"     This is a prospective case control study. Participants will be enrolled as case subjects or     control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The     chemotherapeutic regimens will be determined per standard of care. Participants will receive     GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic     ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the     interventions. The duration of the study will be approximately 12 months.The study time     includes the time necessary for completion of most cancer treatments in this population,     which approximates 8-12 months, and time to allow complete excretion of the Lupron from the     systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O)     axis. The results of the study will be used to guide a larger study evaluating the efficacy     of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young     subjects receiving chemoradiation.   "
46474|NCT02677298|"     The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of     glabellar lines in comparison with placebo, including efficacy after repeat treatments and     long term safety.   "
46475|NCT02677285|"     This study consists of two clinical series. With the first series investigators monitor the     healing of skin grafts with bioimpedance measurements. The bioimpedance measurement is done     with a purpose built patch that has electrodes in contact with the wound and reference     electrodes.      In the second series the investigators monitor closed operational wounds (breast     reconstruction surgery patients) with bioimpedance measurements. This series is also     conducted with bioimpedance measurements but the wounds are operational wounds.      Both groups will have 20 patients.   "
46476|NCT02677272|"     According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle     Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months     or about 50% per year. These hospitalizations concern for half, transfers to emergency     department (ED). Data from the literature and the PLEIAD study, conducted with 300 NH in     France, confirm that intense flows between NH and ED. These studies also support the idea     that these transfers to ED potentially expose some NH residents to iatrogenic complications,     a risk of functional decline, an increased risk of mortality, and generate additional health     costs. To transfer to ED residents who will benefit from emergency care and not to transfer     to ED residents for whom this transfer generates a higher risk than the expected benefit is     the goal to reach to guarantee the better quality of care for NH residents.      Inappropriate transfer to ED may be defined by the absence of somatic emergency and / or     palliative care known before transferring to ED and / or the presence of advance directives     of non-hospitalization in the resident's file. This is a clinical situation that could be     managed by other means that the transfer to ED without loss of opportunity for the patient.      The primary objective of our study is to determine the factors predisposing NH residents to     inappropriate transfer to ED.      Our hypothesis is that inappropriate transfers to the ED of NH residents are conditioned by     factors accessible to interventions such as the organization of the NH care system or by     improving the management of some diseases in NH. Investigators also hypothesize that the cost     of inappropriate transfers to the ED is considerable. Acknowledgement of costs generated by     inappropriate transfers to ED would allow policy makers to make strategic decisions to     improve care system.   "
46477|NCT02677259|"     Optimizing in vitro fertilization (IVF) success is more important than ever, in light of new     public funding of IVF in Ontario, Canada. In patients undergoing IVF using     gonadotropin-releasing hormone (GnRH) analogues, the luteal phase appears to be compromised,     which may be a result of controlled-ovarian hyperstimulation, significant fluctuations in     hormone levels, the impact of the oocyte retrieval process, or direct compromise of the     corpus luteum. Progesterone support is definitely necessary during the luteal phase to     facilitate implantation but whether estrogen supplementation is also needed remains unclear.     The present study aims to determine whether estradiol support during the luteal phase     improves clinical pregnancy rate in patients undergoing IVF.   "
46478|NCT02677246|"     Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone     damages are caused by both a decrease of bone formation and an increase of bone destruction     after BMT.For long term survivors, bone complications are major determinants of impaired     quality of life. No standard treatment currently exists to prevent those bone injuries.     Denosumab is a treatment which specifically blocks bone destruction for 4 to 6 months in     adults. This trial will study whether it is safe to prescribe Denosumab to children after BMT     in the aim of preventing bone complications.   "
46479|NCT02677233|"     To find out if lower levels of vitamin D is more prevalent in preeclamptic women   "
47000|NCT02670421|"     Will the intervention (Heart SMART program) be feasible in moderate or high stress patients,     who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic?   "
46485|NCT02677155|"     Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin's lymphoma and is     often diagnosed in advanced incurable stage. In our previous trail, Lymvac-1, patients were     treated with sequential intratumoral injections of low-dose rituximab and autologous     dendritic cells, combined with local radiotherapy at the same site. The aim was to overcome     tumor tolerance. In this trial, clinical responses correlated strongly with systemic     anti-tumor CD8+ T-cell responses detected in blood after therapy. The primary aim of the     planned study (Lymvac-2) is to significantly improve rates of immunological and clinical     responses by adding iv anti-PD-1 antibody (Pembrolizumab) relative to the cohort of patients     previously treated with intranodal immunotherapy without Pembrolizumab (Lymvac-1). The study     includes 20 patients with untreated or relapsed FL.   "
46499|NCT02676973|"     The study is a multi-center, randomized, surgical trial of women with symptomatic     post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare     the three available surgical treatments performed in usual practice. The purpose of this     study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical     Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The     primary outcome is measured over time (up to 60 months) using a survival analysis approach.      The investigators hypothesize that treatment failure will not differ between vaginally and     abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of     implantation) will be superior to native tissue apical suspension.   "
46486|NCT02677142|"     Tumours affecting the brain are a very heterogeneous group of diseases. Accordingly,     treatment strategies vary widely depending on child's age, tumour location, its resectability     and histology. As a group, however, the survival rate of childhood brain tumors has improved     in recent years, resulting in an increased number of survivors returning to school and     reintegrating into their communities. Survival for many of them, however, has also come with     severe costs such as neurocognitive and academic difficulties. Cognitive rehabilitation     strategies to address these deficits have been a major focus of recent research. Evidence is     now also mounting for social competence deficits among this population which may persist into     late adolescence and adulthood, thereby negatively affecting long-term survivorship. Thus,     there is an urgency to identify psychosocial interventions, such as social skills programs,     that can reduce the social competence deficits in childhood brain tumor survivors and,     therefore, modify the course of these outcomes to ensure that survivors thrive and become     productive members of society. To date, no rigorous social skills intervention trials have     been undertaken to address the social difficulties of these survivors. The current proposal     is the first study that aims to address this gap by evaluating the efficacy of an innovative,     manualized, social skills intervention program developed for this population using a     multi-centre Randomized Control Trial (RCT).   "
46487|NCT02677129|"     The study is a randomized controlled trial with the aim to examine the feasibility and the     effects of a home-based exercise intervention program on activities of daily living (ADL) in     patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment. Further     outcomes include functional and body status, quality of life, body composition, and     chemotherapy completion rate. Study participants will be randomized to an exercise     intervention group or a wait-list control group   "
46488|NCT02677116|"     The main purpose of this study is to evaluate the safety of different doses of olaratumab and     to determine which dose should be used for future pediatric studies. The present study is     open to children with advanced cancer or cancer that has spread to another part of the body.     The study has two parts. In each part, a specific dose of olaratumab will be given for 21     days, followed by one of three standard chemotherapy regimens. Participants will only enroll     in one part.   "
46489|NCT02677103|"     Calcific tendinitis of the shoulder is a common enthesopathy, and is characterized by     inflammation around calcium hydroxyapatite crystal deposits, usually located in the     supraspinatus tendon, near its insertion place.1 The disease mainly affects individuals     between 30 and 50 years of age, is painful in 50% of patients and frequently leads to     considerable restriction of motion.2,3 It goes through three distinct stages: a precalcific     stage (metaplasia of matrix), calcific stage (calcification of matrix and resorption of     calific deposits), and a postcalcific stage (reconstitution of matrix).      Classifications of calcific tendinitis have been proposed previously. Gartner proposed a     classification based on plain films of the shoulder: type I deposits were sharply outlined     and densely structured. Type III deposits had a cloudy outline and were transparent in     structure. Type II deposits were features of both.4 Type III plaques have a tendency to     resorb. Due to the progress of musculoskeletal ultrasound over the past decade,     classification of the calcific tendinitis based on ultrasound findings was also proposed:     arc-shaped (an echogenic arc with clear shadowing), fragmented or punctate (at least 2     separated echogenic spots or plaques with or without shadowing), nodular (an echogenic nodule     without shadowing), and cystic (a bold echogenic wall with an anechoic area).5 Plaques that     appear fragmented, nodular, or cystic on ultrasound are considered in the resorptive phase.      The treatment of patients with calcific tendinitis is typically conservative. The reported     success rates vary between 30 and 85%.6 If the pain becomes chronic or intermittent after     several months of conservative treatment, arthroscopic and open procedures are available to     curette the calcium deposit, and additional subacromial decompression can be performed if     necessary.7,8 As an alternative, minimally invasive extracorporeal shock wave therapy (ESWT)     has been postulated to be an effective treatment option for treating calcific tendinopathy of     the shoulder, before surgery.9-12 In recent years, radial shock wave has been developed. A     radial shock wave is a low- to medium-energy shock wave that is pneumatically generated     through acceleration of a projectile inside the handpiece of the treatment device and then     transmitted radially from the tip of the applicator to the target zone. Radial shock wave     showed a low pressure and a considerably longer rise time than extracorporeal shock wave. In     radial shock wave therapy (RSWT), the focal point is not concentrated on the target zone, as     occurred in ESWT, but on the tip of applicator. 13 Another new method of conservative     treatment of calcific tendinopathy is ultrasound-guided fine-needle repeated puncture of the     calcific plaque, as shown in previous study.14,15 The new method has the advantage of being     easily operative, cheap, safe, and has a proven high success rate. Although percutaneous     needle aspiration with a large size needle(≥ 18# needle) alleviates symptoms in up to 60% of     patients and resolves the deposits in 40% to 74%,16,17 the larger size needle could result in     tendon injury.      In clinical practice, combination of radial shock wave therapy and ultrasound-guided fine     needle repeated puncture is frequently used and shows promising results, however, scientific     report has been rarely published before.18 The purpose of this study is to compare the     efficacy of RSWT, ultrasound-guided fine needle puncture (USNP), and combination of RSWT and     USNP in the treatment of calcific tendinitis of shoulder.   "
46490|NCT02677090|"     Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years     old.   "
46491|NCT02677077|"     The primary objective of the study is to retrospectively investigate the proportion of     participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions     over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants     with regular MRI follow-up, who have received natalizumab ≥24 month from two different     observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2)     approximately 70 participants from Belgium. The secondary objectives of this study are as     follows: Brain volume change by various measures; Changes in the number and volume of     magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and     without brain volume change.   "
46492|NCT02677064|"     The investigators are doing this research study to assess the percentage of patients     receiving stem cell transplantation for the type of blood cancer you have. They want to know     how many patients get a transplant and why some patients do get a transplant while others do     not. Also they want to explore why some patients elect not to undergo stem cell     transplantation, when it is recommended by their physicians.   "
46493|NCT02677051|"     This study is a double blind treatment trial that will test if sulforaphane improves core     symptoms in autism. The investigators expect to see clinical improvement in some of these     areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators     will be using a preparation that gives specific and reproducible amounts. The investigators     will also test specific chemicals and genes needed for sulforaphane usage to try to     understand differences in response.   "
46494|NCT02677038|"     The goal of this clinical research study is to learn if olaparib can help to control     metastatic pancreatic cancer. The safety of this drug will also be studied.   "
46495|NCT02677025|"     This supplement study is an adaptation of the larger NIH-funded parent study, the Women's     Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance     standard HIV testing practices for alcohol and drug (AOD)-using women across the city of     Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female     adolescents who experience the greatest burden of new HIV infections and are currently     underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the     validation of both the instrument and adapted intervention.   "
46496|NCT02677012|"     During reconstructive surgery that involves autologous fat grafting (AFG -- transplanting     fatty tissue from one part of your body to another), fat tissue is removed from one part of     the body (usually the abdomen or legs) and inserted into another part of the body.      This fat must be cleaned and filtered (processed) before being inserted back into the body.      The goal of this clinical research study is to compare 3 techniques for processing fatty     tissue that is collected during reconstructive surgery. Researchers want to compare the     amount of fat processed and the length of time needed to complete AFG technique and surgery.   "
46652|NCT02674984|"     This study will evaluate the safety and tolerability of combination probiotic BB-12 with LGG     in healthy children with autism spectrum disorder aged 4-15 years. Subjects will be     randomized to BB-12 with LGG orally (LGG dose: 10^9 c.f.u.'s; BB-12: 10^9) for a total of 56     doses or placebo (maltodextrin) at 2:1 ratio. The time on study treatment is 56 days, and the     target sample size is 30 individuals (i.e., 20 in the treatment arm and 10 in the placebo     arm).   "
46497|NCT02676999|"     This project is set to describe by objective measures as the range of motion and     weight-bearing ability of the distal radioulnar joint one to five years after primary     implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and     stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function,     especially the pronation and supination. Unlike other ulnar endoprostheses that replace only     the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid     notch, and is semi-constrained in design.   "
46503|NCT02676921|"     The objectives of this study are :        1. to test the the osteogenic potential of human maxillary sinus schneiderian membrane          (hMSSM).        2. To investigate the expression of mesenchymal stem cell marker (STRO-1), a marker of          mesenchymal progenitor cells using flow cytometry, and Alkaline phosphate expression,          Red alizarin and Von Kossa staining and quantitive PCR.   "
46504|NCT02676908|"     Compression stockings are traditionally worn for a period of time after varicose vein surgery     to reduce pain and bruising. The investigators provide an ambulatory endovenous ablation     service. Patients come to the Veins Unit, receive oral sedation, have their veins treated     with either laser or radiofrequency ablation plus phlebectomies* under local anaesthetic,     recover for an hour and then go home. *Phlebectomy describes the technique of pulling out     small varicose veins through small incisions in the overlying skin. The standard practice of     the Veins Unit is to advise patients to wear class two compression stockings for four weeks     post-operatively. Many patients would prefer a shorter period of time in stockings.      The Nice Guidelines for Varicose Veins has posed the question: 'How long should stockings be     worn for after endovenous ablation?'      Three trials have addressed this issue:      Bakker looked at patients who wore stockings for either two or seven days after laser     ablation only; the group who wore stockings for seven days fared better.      Elderman looked at patients who either wore no stockings or stockings for two weeks after     laser ablation only; the group who wore stockings for two weeks had less pain.      Krasznai looked at patients who wore stockings for either 4 hours or 72 hours after     radiofrequency ablation only; there was no significant difference in post-op pain among     groups.      None of these trials included patients who had phlebectomies at the same time. This study     aims to answer the question 'How long is it necessary to wear compression stockings for after     endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?' The     investigators plan to divide 110 patients into two groups- either 'stockings for 2 weeks'     (trial group) or 'stockings for 4 weeks' (usual treatment group).      Pre-operatively, all patients will fill out a pain score and two short quality of life     questionnaires, one specific to varicose veins. Post-operatively at home, all patients will     be asked to keep a diary of pain and analgesia use. They will also document bruising at seven     days on charts and on a visual scale. At their four week clinic review, all patients will be     asked to fill out a pain and bruising score, a bruising chart and the two short quality of     life questionnaires again.      The group with the best pain, bruising and quality of life scores post-operatively will help     guide duration of compression therapy for future patients.   "
46505|NCT02676895|"     The purpose of this study is to evaluate the safety and the immunogenicity of two different     doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards     testing of the GMMA vaccine in the vaccine target population of children from developing     countries where shigellosis is endemic.   "
46506|NCT02676882|"     The purpose of this study is to assess the effectiveness of the EnBrace HR prenatal     supplement in preventing depression in women with a history of depression who have decided to     stop taking antidepressants during their pregnancy, or treating women who are currently in a     depressive episode while pregnant or planning pregnancy.   "
46507|NCT02676869|"     The purpose of this study is to determine the safety, tolerability and recommended phase 2     dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients     with unresectable or metastatic melanoma.   "
46508|NCT02676856|"     The purpose of this study is to evaluate the efficacy of hematopoietic stem cell     microtransplantation for in acute myeloid leukemia (AML)patients who can not receive     hematopoietic stem cell transplantation (HSCT).   "
46509|NCT02676843|"     The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect     depositions of a protein, called tau, in the brains of people with a mutation in the tau gene     that causes deposition of the protein, and in people without the mutation. A single     18F-AV-1451 scan will be performed on control subjects without MAPT mutations, presymptomatic     mutation carriers, and symptomatic mutation carriers.   "
46510|NCT02676830|"     The purpose of this study is to Evaluation of absorption, metabolism, and excretion of     [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects   "
47001|NCT02670408|"     Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care     for heart transplant patients.   "
46511|NCT02676817|"     The aim of the study is to construct and validate an endomicroscopic score correlated with     microscopic inflammation activity in patients with UC.      Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which     offers the possibility to perform in vivo mucosal microscopic analysis in real time during     endoscopy.      Primary Objectives : Development and validation of a UC endomicroscopic score, after     correlation between pCLE data and histological data using the Geboes' score as a gold     standard during ulcerative colitis.      Secondary Objectives:        -  Identify predictive factors for the response to adalimumab.        -  Identify predictive factors for recurrence in patients with UC in remission (Mayo score          0 or 1).        -  Safety of the pCLE procedure   "
46512|NCT02676804|"     This is a prospective, pre-post intervention study to evaluate the effect of a     high-intensity, aerobic exercise program on outcomes of cognition, mood, gait, balance,     cardiorespiratory fitness, neuromuscular performance, fatigue, sleep, and quality of life for     patients diagnosed with idiopathic Parkinson disease. The primary outcomes will be a     composite measure of cognitive function and the Timed Up and Go (TUG).   "
46513|NCT02676791|"     The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel     arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes     in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is     defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant     recurrence, disease-specific survival and esophageal cancer specific survival.   "
46514|NCT02676778|"     The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in     participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous     T-cell lymphoma (CTCL).   "
46515|NCT02676765|"     The purpose of this study is to determine if sublingual allergen immunotherapy tablets work     by inducing a state of desensitization in mast cells and basophils.   "
46516|NCT02676752|"     This research trial studies skin/soft tissue elasticity in head and neck cancer survivors     with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck     cancer which may lead to skin tightness, pain, and body image issues. Early detection of     lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave     elastography is a technique that provides a quantitative measure of stiffness using a push     pulse to generate shear waves within the tissues. Conventional imaging techniques are then     used to monitor the shear waves generated through the tissue to calculate the shear wave     speed. Shear wave elastography may help obtain an early and accurate measurement of tissue     elasticity in head and neck cancer survivors.   "
46576|NCT02675972|"     Previous studies on the association between blood pressure variation (BPV) in acute ischemic     stroke and functional outcomes yield conflicting result. The obscured definition and     measurement of BPV engenders considerable confounding factors, making it difficult to     interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in     acute non-cardiogenic ischemic stroke.   "
46517|NCT02676739|"     This 12 week randomized placebo-controlled study will compare the effects of 10 mg and 20 mg     of a mixed amphetamine salt, extended release medication (trade name Adderall XR) to placebo     on objective measures of processing speed and memory, as well as on self-reported measures of     cognition and quality of life. To be enrolled in the study, MS subjects must demonstrate     impaired processing speed on the Symbol Digit Modalities Test (SDMT).   "
46518|NCT02676726|"     The purpose of this study is to determine whether or not there are more complications in the     extraperitoneal compared with the transperitoneal approach for laparoscopic aortic     lymphadenectomy for the surgical staging of endometrial or ovarian cancer   "
46519|NCT02676713|"     Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are     infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and     moderate endometriosis increases live birth or ongoing pregnancy rates. There was no evidence     of benefit for post-surgical hormonal suppression of endometriosis compared to surgery alone     for the outcomes of pregnancy rates. Past studies have confirmed that Chinese herbal medicine     can inhibit post-surgical endometriosis recurrence, increase pregnancy rate.This study     evaluates the efficacy and safety of Traditional Chinese Medicine Sequential Treatment of     endometriosis-associated infertility. The study objective is to confirm that clinical     pregnancy rate of patients with endometriosis-associated infertility post-conservative     surgery accepting Chinese medicine activating blood, dredging liver and nourishing kidney     sequential treatment is higher than expectant treatment.   "
46520|NCT02676700|"     This study examines the effect of adding so called Kaatsu training to pelvic floor muscle     training. Half the participants will perform Kaatsu training on their thigh muscles followed     by pelvic floor muscle training. The other half will receive pelvic floor muscle training     alone.   "
46521|NCT02676687|"     Gliomas, especially high grade gliomas and diffuse low grade gliomas, are characterized by     their infiltrative nature. Recently, a new conception of supratotal resection has been     proposed. Given the lack of prospective supporting data, the correlation between supratotal     resection and the survival of patients with glioma need to be established.      Therefore, the investigators aim to do a single center prospective randomized controlled     clinical trial to assess the effect of supratotal resection at least 1 cm beyond the MR     imaging-defined abnormalities on progression-free survival (PFS) of glioma.   "
46522|NCT02676674|"     This is a pre-post open label trial to assess the change in Vitamin D blood levels following     treatment with three doses of topical Vitamin D3 in 20 subjects with existing Vitamin D     deficiency.   "
46523|NCT02676661|"     To investigate the prevalence and risk factors for peri-implant disease in partially     edentulous patients rehabilitated with implants supported crown or bridge so as to provide     evidence for clinical prevention and control.   "
46524|NCT02676648|"     The goal of the research is to optimize an online and mobile multicomponent 12-month diet and     lifestyle intervention for improving the blood glucose control of individuals with type 2     diabetes.   "
46537|NCT02676479|"     The study will involve up to 30 pairs of male and female sexually intimate partners who are     carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of     transmitting the gene. The female partner will be superovulated to mature multiple oocytes     which can be fertilized, inseminated with her partner's sperm through intra-uterine     insemination (IUI). Four to six days after IUI, the female partner will undergo a     non-surgical uterine lavage procedure to recover preimplantation embryos.   "
46538|NCT02676466|"     ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing     major mobility disability by improving or preserving walking ability.   "
46525|NCT02676635|"     Masons have the highest rate of overexertion injuries among all construction trades and rank     second as an occupation for back injuries in the United States. Identified ergonomic     solutions are the primary method of reducing exposure to risk factors associated with     musculoskeletal disorders. However, many construction workers lack knowledge about these     solutions, as well as basic ergonomic principles. Construction apprentices, as they embark on     their careers, are greatly in need of ergonomics training to minimize the cumulative exposure     that leads to musculoskeletal disorders. Apprentices receive safety training; however,     ergonomics training is often limited or non-existent. In addition, apprenticeship programs     often lack soft skills training on how to appropriately respond to work environments and     practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to     integrate evidence-based health and safety training strategies into the mason apprenticeship     skills training to teach ergonomics, problem solving, and speaking up to communicate     solutions that reduce musculoskeletal injury risk. The central hypothesis is that the     combination of ergonomics training and safety voice promotion will be more effective than no     training or either ergonomics training alone or safety voice training alone.      Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated     in a cluster-randomized controlled trial at 12-15 masonry training centers across the U.S.     Clusters of apprentices within centers will be assigned at random to one of three     intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined ergonomics     and safety voice training, or (3) control group with no additional training intervention.     Outcomes assessed at baseline, at the conclusion of training, and then at six and 12 months     post training will include: musculoskeletal symptoms, general health perceptions, knowledge     of ergonomic and safety voice principles, and perception and attitudes about ergonomic and     safety voice issues.   "
46526|NCT02676622|"     Crohn's disease is an 'auto-immune' disorder of the gut. In this condition the body's own     immune system is fighting its gut and causing inflammation and other symptoms. Patients who     are refractory (not responding) to the medications usually used to control Crohn's disease     (medicines like steroids, azathioprine, methotrexate, cyclophosphamide and antibodies like     Infliximab), may consider being part of this study.      In this study, the investigators plan to wipe out (ablate) the 'faulty immune system' with     medicines (immune-ablation) and then give back the patients own stored stem cells (that have     been collected before) - a procedure called autologous (self) stem cell transplant (ASCT).     Once the new immune system regrows again from the stem cells, it is hoped that the 'faulty'     immune cells do not return again and do not fight the gut leading to remission from symptoms     of Crohn's disease. The aim of this treatment therefore, is to reset or re-program the immune     system, so that it does not fight the patient's own body.      Currently, there are very few trials and experience with this procedure in children and young     adults. There have been a few studies that have shown benefit of ASCT procedure in adult     patients. In some patients, the benefit lasted for 1-5 years; but 1 in 5 (20%) participants     were not taking their medications for the Crohn's disease even 5 years after ASCT. Other 80%     needed medications again, but in most cases with better disease control.      In order to potentially improve the long term outcomes of ASCT, the investigators are adding     another medication (in addition to those used in adult studies) called IL-2 (Aldesleukin),     which will be given as an every-other-day injection under the skin (subcutaneous) at very low     doses for 6 weeks after the ASCT and can be taken at home. Low dose IL-2 is known to increase     a type of immune cell called T-regulatory cells (Tregs) that make immune cells less reactive     to self. Study doctors believe that increased population of Tregs after ASCT may lead to a     better control of Crohn's disease- higher percentage of cures or disease control for a longer     period of time compared to the previous adult trials.      Therefore, the goals of this study are-        1. To see if ASCT can be used safely and can provide substantial benefit in young adults          who have refractory Crohn's disease.        2. To see if addition of IL-2 after the ASCT is safe and effective.   "
46592|NCT02675764|"     The objective of this pilot project is to assess the impact of the novel sensory stimulation     technique the investigators have developed in enhancing outcomes of hand therapy as well as     the central nervous system responsiveness in chronic stroke survivors.   "
46527|NCT02676609|"     During this study, we will assess a new smart phone application which aims at helping     patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients,     already trained to carbohydrate counting, will be recruited among those who have been using     this method daily for at least 6 months. They will complete two one-month study phases, using     the application in one phase and counting carbohydrate and insulin doses without the     application in the other phase, with randomized order of each phase. Visits are scheduled at     the start and at the end of each phase to collect data on glucose control and insulin doses.     Questionnaires assessing health-related quality of life and ability of self-management of     diabetes will also be filled by patients before and after each study phase.   "
46528|NCT02676596|"     The purpose of this study is to investigate the safety tolerability, and PK profile of K-312     and its metabolites in healthy Japanese and non-Japanese adults.   "
46529|NCT02676583|"     Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An     inexpensive method and with few evidence in the literature on effectiveness in reducing pain     is the closure of the tonsillar fossa by suture with absorbable sutures. The investigators     will compare the pain after tonsillectomy between closure or not the tonsil fossa.      Study design: Prospective, randomized, double blind, and controlled. Method: Two hundred     otolaryngologic outpatients with indication of bilateral tonsillectomy for repeated     tonsillitis, tonsillar hypertrophy or sleep apnea between 5 and 12 years old will be enrolled     from November 2015 to July 2016. The procedure will be performed by a single surgeon and     similar postoperative medications will be prescribed. There will be two techniques: closure     or not of the tonsillar fossa with catgut points. A questionnaire containing a Faces Pain     Scale - filled 1 and 7 days after surgery- and other data - difficulty of detachment of the     palatine tonsils, hemostasis technique, surgical complications, healing characteristics, day     of total improvement of the pain, day of beginning of normal food intake, presence of     postoperative bleeding, complications and observations raised by the patient - will be     applied.   "
46530|NCT02676570|"     1. Isolate fungal DNA(Deoxyribonucleic acid) from paraffin-fixed tissue specimens to          distinguish and compare Aspergillus species to the existing optical pathological          diagnosis.        2. PCR(polymerase chain reaction) validation.        3. Compare PCR results, microbial results and treatment results with the medical record.   "
46531|NCT02676557|"     The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the     change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study.     In the present study, the investigators intended to investigate whether the changes of the     deep and superficial structures around ONH exist or not using EDI OCT.   "
46532|NCT02676544|"     This is a prospective, open label single center feasibility study to demonstrate basic safety     and effectiveness of prostate artery embolization for the treatment of symptomatic benign     prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.   "
46533|NCT02676531|"     This study is to evaluate the effects of Walking Meditation on vascular function in breast     cancer patients receiving Anthracyclines chemotherapy   "
46534|NCT02676518|"     Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose     intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)   "
46535|NCT02676505|"     The primary purpose of this study is to compare the effects of two different methods of care     during the second stage of labor for nulliparous women (coached versus uncoached pushing) on     the length of the second stage and how this may affect maternal and neonatal outcome.   "
46536|NCT02676492|"     This study will explore the relationship between sleep, learning, cognition, mood and     behaviour in children with Tic Disorders (Tourette Syndrome and Chronic Tic Disorder)     compared to typically developing peers.   "
46539|NCT02676453|"     Objective: The aim of this study was to evaluate the effects of dental hygienist support on     oral health and attitudes to oral healthcare in nursing homes for older people.      Background: Studies in long-term care facilities have indicated that oral health is often     unsatisfactory. It is important that nursing staff are able to assist dependent care     recipients. Dental hygienist support has been suggested as valuable help.      Material and methods: Two nursing homes were randomly selected for intervention and control.     Interventions included weekly support from dental hygienists on oral hygiene procedures,     prescriptions for individual oral hygiene procedures, and oral care organisational issues.     The residents' oral health, measured by dental plaque levels, gingival bleeding and the     Revised Oral Assessment Guide (ROAG), was evaluated before and after three months. Attitudes     among the staff to oral healthcare were collected through a questionnaire.   "
46540|NCT02676440|"     This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy     female and male participants aged over 18 years will participate. There will be two groups of     up to 120 participants. Participants will be randomised to the test groups according the     allocation table prepared by the Statistician.      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.     After enrollment participants will have their teeth that have been allocated for assessment     cleaned using a professional prophylaxis polish by the study dentist. The participants will     then be provided with a standard cosmetic silica Fluoride toothpaste and a toothbrush to use     at home, twice a day for up to four weeks. After this time they will return to the test site     and have the baseline dental assessments. Participants will then be randomly allocated to one     of the two test products which they will use at home, twice a day for the duration of the     study. Dental assessments will be conducted after 13 and 26 weeks of product use at the study     site.   "
46541|NCT02676427|"     The study aims at clarification of venous collapsibility measures with real venous flow     measurements during dynamic maneuver testing fluid responsiveness in septic shock patients.   "
46542|NCT02676414|"     The primary purpose of this study is to assess the effect of participating in the interactive     hypertension education program of the German Hypertension League (DHL©) My blood pressure -     OK! on office systolic blood pressure.   "
46543|NCT02676401|"     This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer     term, following MT-3995-J05 study.   "
46544|NCT02676388|"     The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh     FMT in adults with slow transit constipation.   "
46545|NCT02676375|"     The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic     and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into     three arms of treatment for smoking cessation treatment, receiving either 1. Control:     standard therapy (n=15), including stepwise monotherapy of nicotine patch or bupropion     sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and     nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion,     nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to     the home or living facility. During all treatments, participants will receive weekly smoking     cessation group counseling, as is standard for smoking cessation treatment. At the time of     enrollment, participants will complete a one-study visit lead-in to complete baseline     assessments, psychological and medical evaluation, and comprehensive assessment of drug use     to determine study eligibility. Once determined to be eligible for the trial, participants     will be randomly assigned to one of the treatment arms using a randomization procedure. The     standard therapy treatment arm, or control group, will receive either nicotine patch taper     starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained     release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The     extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine     lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg     daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6     months (as tolerated). The third arm will be identical to the second arm except for the added     home visit intervention.   "
46546|NCT02676362|"     The mechanisms underlying the formation and composition of gingival crevicular fluid (GCF)     and its flow into and from periodontal pockets are not understood very well. The aim of this     study was to evaluate the length of sampling time and sequential sampling of GCF neutrophil     elastase (NE) enzyme activity by using intracrevicular and orifice methods.   "
46547|NCT02676349|"     This is a prospective, randomized phase II trial. The aim of this study is to assess the     efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic     cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without     preoperative chemoradiotherapy with capecitabine.   "
46548|NCT02676336|"     This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the     safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast     health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of     effectiveness.   "
46559|NCT02676193|"     The investigators are addressing two critical areas identified by the FDA: the impact of     cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the     effectiveness of graphic warning labels on communicating risk of tobacco products. In a     randomized controlled trial (RCT), investigators will enroll committed smokers who have no     intention of quitting in the next 6-months. The three study arms will be: a) a plain pack     with all marketing materials removed (PP); b) The Australian graphic warning images     (Australian model-AM); or c) a standard pack with all marketing materials unaltered (ST). The     study includes a three month purchasing intervention and continued follow-up through 12     months. Throughout the study interactive text messaging assessments will be used to measure     acute and persistent impact of labeling and marketing on perceptions of tobacco products,     subjective effects of consumption, awareness of tobacco-related harms, tobacco use behavior,     and quitting motivation. At three separate time points, participants will: a) complete a     web-based questionnaire b) provide a saliva sample for cotinine analysis. The rigorous design     and extensive objective measurements are significant innovations on the currently published     research in this field and should lead to significant advances in tobacco regulatory science.   "
46549|NCT02676323|"     Cancer is the uncontrolled growth of human cells. The growth of normal human cells is     controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs     called histone deacetylase (HDAC) inhibitors. HDAC inhibitors like panobinostat block     enzymes known as histone deacetylases, which stops cancer cells from dividing and causes them     to die. Fludarabine and cytarabine are chemotherapy drugs that are commonly used to treat     pediatric patients with refractory or relapsed acute myeloid leukemia (AML) or     myelodysplastic syndrome (MDS).      The purpose of this study is to test the safety of panobinostat and to find the highest dose     of panobinostat that can be given safely when it is combined with fludarabine and cytarabine.      This pilot study will be done in two parts: The goal of Part 1 of the study is to find the     highest tolerable dose of panobinostat that can be given to patients with AML or MDS, when it     is combined with fludarabine and cytarabine. Once that dose is determined, participants will     be enrolled on Part 2: Dose Expansion, to look at the effect of the     panobinostat/fludarabine/cytarabine combination in patients with leukemia/MDS.      PRIMARY OBJECTIVE:        -  Determine a tolerable dose of panobinostat when given in combination with fludarabine          and cytarabine in pediatric patients with relapsed or refractory AML or MDS.      SECONDARY OBJECTIVES:        -  Characterize the pharmacokinetics of panobinostat after the first dose and at          steady-state.        -  Estimate the overall response rate to the combination of panobinostat, fludarabine, and          cytarabine.   "
46550|NCT02676310|"     This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients     with androgenetic alopecia (AGA).   "
46551|NCT02676297|"     The purpose of this study is to compare the absorption of two different inhalation products     with the reference product in healthy volunteers.   "
46552|NCT02676284|"     This was a prospective, open, non-comparative study in 36 subjects with rhizarthrosis     comparing signs and symptoms before and after a single injection of DUROLANE SJ in the     affected hand. Subjects were assessed pre-treatment and at 1, 3, and 6 months post-treatment.   "
46577|NCT02675959|"     This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and     toxicity of administering Defibrotide prophylaxis for high-risk sickle cell patients     undergoing a familial haploidentical allogeneic stem cell transplantation with CD34     enrichment and T-cell addback. This patient population historically has a risk of developing     sinusoidal obstructive syndrome (SOS) and Defibrotide has demonstrated efficacy in treatment     of SOS.   "
46578|NCT02675946|"     This is a multicenter, open-label, Phase 1 study consisting of a Dose Escalation Phase and a     Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.   "
46553|NCT02676271|"     Background: Varus derotation osteotomy (VDRO) is one of the most popular surgical treatments     for Legg-Calvé-Perthes disease yet its long term results have not been assessed. Our purpose     was to determine the long term clinical and radiographic outcomes of these patients.      Methods: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long     term follow-up study a decade ago were approached for the present study.      All patients were treated in our institution during 1959 to 1983 with proximal VDRO.      The patients were invited to for a medical interview and a physical examination. They were     also asked to fill out questionnaires and to provide or undergo a standing anteroposterior     (AP) pelvic and a lateral hip radiographs during the visit.      Patients were asked to self-grade their hip pain as none, mild, moderate or severe and to     grade their back pain using the Visual Analogue Scale (VAS) between 0-10. Details regarding     daily function, physical activity, work status and family history were obtained. All     participants completed the Harris Hip Score (HHS) with a maximum score of 100 and the Short     Form-36 which is composed of 8 sections and has a maximum score of 100.      The physical examination included an assessment of the hip range of motion, leg length     discrepancy and the presence of a Trendelenburg sign.      Radiographic parameters evaluated were the Tonnis grade (with a score between 0-3), head size     ratio, and the center-edge (CE) angle.   "
46554|NCT02676258|"     The objective of this study is to evaluate a new daily disposable silicone hydrogel soft     contact lens by comparing to an existing daily disposable soft contact lens.   "
46555|NCT02676245|"     To address the content, timing, efficacy, and impact of prenatal education about newborn     screening generally and sample retention specifically.   "
46556|NCT02676232|"     Chronic and recurrent pain is a very important issue in the society, and its treatment is     challenging.      In children, one of the most common pain problems is recurrent abdominal pain. This problem     can affect up to 12% of the children population, and can interfere on daily activities of     both children and parents. Recurrent abdominal pain in children is also associated with other     health problems, and can be related to problems in adulthood. Unfortunately, the current     health system does not have an effective treatment for these children and their families.     This is why the investigators propose an online intervention, DARWeb, for people in this     situation.      DARWeb provides an innovative solution using Information and Communication Technology to     facilitate access. It is also innovative because it is directed towards secondary prevention,     in contrast to the majority of current treatments available for pain problems that are     focused in reducing the impact of pain when it is already severe. Thus, the objective of     DARWeb is to provide information and teach strategies to children and their parents that help     them to cope with pain and prevent pain interference in their daily lives (in the short,     medium and long term).      With this project, the investigators plan, first, to create a new version of their treatment     program (DARWeb V2) from the results of the pilot study. Second, the investigators will test     the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they     will assess the short, medium and long term effects. In addition, the investigators want to     study which of the variables that are addressed in their intervention are responsible for the     potential changes observed.      The investigators expect that their treatment program will be effective to reduce pain in the     short, medium and long term.   "
46557|NCT02676219|"     The study design is a randomised, split mouth, blind with respect to study analysts     (microscopist, image grader) two treatment clinical study in 10 healthy participants with     sound tooth enamel. The study will comprise of a screening visit, pre-baseline visit and 5     subsequent clinic visits. At the screening visit, participants will give consent to     participate in the study. Medical history and concomitant medications will be recorded.     Eligibility will be determined following an oral soft tissue (OST) examination and an     evaluation of dentition exclusions. Two suitable anterior teeth will be identified for study     assessments, these teeth must be at least one tooth apart in the mouth. Saliva samples will     be collected from the participants at set points during the study to look at any changes in     salivary pH.   "
46558|NCT02676206|"     The investigators propose to determine whether listening to classical music during a sedation     procedure decreases the need for procedural sedation medication. It is a two arm study     comparing music vs no music by headphones so that the investigator is blinded to the     intervention. The outcome variable is amount of sedative used and self-reported anxiety level     as reported on a 10 point visual analogue scale (VAS). The music intervention is begun 1     minute prior to the sedation procedure and continued until the subject is completely awake.     Demographics will be collected for all patients. No identifiers are collected. Data will be     compared for a change in VAS variable using non parametric methods.   "
46610|NCT02675530|"     This study investigates the common features of electrophysiological measures in schizophrenia     and effects of NMDA antagonist ketamine in healthy volunteers.   "
46560|NCT02676180|"     DETECT I is a prospective multicentre observational diagnostic study to assess the     performance of the UroMark assay to rule out bladder cancer in patients with haematuria. The     study will recruit consecutive patients attending haematuria clinics as well as patients     referred to urology outpatient clinics for investigation of haematuria. Consenting patients     will be provided with a urine sample collection kit and asked to provide a urine sample. An     additional urine sample for control assay testing will be provided after the clinic     attendance.   "
46561|NCT02676167|"     This developmental research grant award (R21) requests funds to explore the feasibility and     impact of a public health system PrEP intervention in a recently emerging HIV epidemic in     Athens Greece. The investigators propose a modeling approach using an Agent Based Model (ABM)     that moves beyond basic pathogen and transmission patterns to dealing with complex social     interactions, including overlapping social and sexual networks as well as implementation     realities, like finite PrEP resources, delayed linkage to PrEP care and early PreP care     retention based upon empirically collected data in Athens Greece.   "
46562|NCT02676154|"     This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in     patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of     increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary     bladder contractions.   "
46563|NCT02676141|"     This study evaluates if the German Version of the NDI is sensitive to change over time.   "
46564|NCT02676128|"     Inadequate adherence to antiretroviral therapy (ART) can impede successful viral suppression     and consequently lead to negative health consequences. This study aims to refine and test the     efficacy of a mobile health ART adherence application (ARTAA), delivered over a smartphone,     with helping individuals improve their ART adherence.   "
46565|NCT02676115|"     This is a prospective, single-blinded, two-arm, randomized, parallel, pragmatic,     effectiveness trial that will enroll patients undergoing arthroscopic anterior cruciate     ligament reconstruction in order to evaluate the efficacy of using Medipore tape to improve     cosmetic wound healing and scaring.   "
46566|NCT02676102|"     The primary purpose of this 3-phase mixed methods design study is to investigate how     presenting content at varying levels of audience specificity (generic, targeted, and     tailored) influences organ donor registration behavior among black men using video-based     educational programming produced and distributed in partnership with our network of Black     Owned Barbershops (BOBs). Investigators have completed a development phase using digital     video interviewing to both derive and provide culturally specific content for the videos.     This phase of this investigation is a 3 arm randomized control trial (RCT) phase, in which     customers will be randomized to receive the generic, targeted, or tailored video programming     delivered with iPads, after which an immediate organ donation opportunity will be offered     through registration online or with a mailed in application. The final phase of this     investigation will be a failure analysis whereby we will interview a subset of participants     who registered or failed to register one month after their educational session to ascertain     how the programming impacted their decision (Aim 3 - the subject of a future IRB     application).   "
46567|NCT02676089|"     The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI     (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus     glycopyrronum bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine     beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993     200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of     lung functions parameters and rate of exacerbations, as well as to assess its safety and some     health economics outcomes.   "
46568|NCT02676076|"     The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI     (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus     glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine     beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters     and rate of exacerbations, as well as to assess its safety and some health economics     outcomes.   "
46569|NCT02676063|"     The primary objective is to evaluate neonatal characteristics, and biological and clinical     investigations as predictive factors of death, or of severe and moderate neurodevelopmental     disability at 3 years, in a large population-based cohort of full-term and late preterm     neonates with moderate or severe HIE.      Contrary to most previous studies which have often analyzed the accuracy of one factor among     all other clinical investigations, the investigators objective's is to seek a relevant     combination of several factors among the following list:        -  Neonatal characteristics: gestational age and birthweight, maternal disease, acute          intrapartum event, delivery mode, acidosis, neurological examination, place of birth and          neonatal transfer        -  Laboratory investigations: pH, lactates and new biological markers as detailed below        -  Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI   "
46570|NCT02676050|"     Lung cancer is currently a major health problem in the UK. Despite being one of the most     common cancers, lung cancer has a poor prognosis compared to other types of cancer and is the     leading cause of cancer death in the world. As opposed to other organs, the lung is highly     susceptible to inflammatory insults, for example from bacterial infection-induced and     tobacco-induced inflammation. It has long been known that the cellular microenvironment that     nurtures tumour growth and development is linked to sites of chronic inflammation but     molecular insights into how external inflammation boosts or inhibits cancer in the lungs     remains unclear. This study aims to directly visualise the expression of a well known marker     of cancerous tissue, c-MET, and the activity of neutrophils in human lung cancer in vivo in     situ using fibre-based endomicroscopy.   "
46571|NCT02676037|"     Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The     current diagnostic tool is using X-ray which is expensive and includes radiation exposure.     The current study is aimed at using the foot pressure platform as an alternative method for     diagnosis and evaluation of the deformity. The main subjects will be recruited from     orthopaedic outpatient clinics.      The recruited subjects will undergo the non-invasive and radiation free study by walking on a     pressure platform. Then their pressure data will be correlated with their radiological study     which has already been done in the clinic. The aimed outcome of the study is use the foot     pressure platform as first line of diagnosis and evaluation of the Hallux Valgus deformity.   "
46572|NCT02676024|"     In-hospital pediatric cardiac arrest is an important public health problem affecting almost     6000 children a year in the United States. As many as 3% of patients admitted to a children's     hospital require cardiopulmonary resuscitation (CPR). Only a minority of children survive, of     which around 35% go on to have a poor neurological outcome. International consensus     guidelines on science and treatment recommendations for the management of pediatric     resuscitation have existed for decades and are revised periodically by the International     Liaison Committee on Resuscitation (ILCOR) based on available evidence. This consensus is     then used by national councils such as the American Heart Association (AHA) and the Heart and     Stroke Foundation of Canada (HSFC) to make guidelines for care. These guidelines focus on a     structured approach to resuscitation, which emphasizes the rapid implementation of key     interventions such as starting chest compressions, administering epinephrine and     defibrillation. The goal of this study is to improve outcomes after cardiac arrest in     children by improving adherence to consensus guidelines. The investigators aim to achieve     this by conducting a multi-center, prospective, factorial randomized study with participating     sites from the International Network for Simulation-based Pediatric Innovation, Research and     Education (INSPIRE).      The specific aims of this study are to:        1. To evaluate the effectiveness of knowledge-based cognitive aids, namely the Pediatric          Advanced Life Support (PALS) algorithm cards, in healthcare teams.        2. To evaluate the effectiveness of teamwork-based cognitive aids, namely the Cognitive          Aids with Roles Defined (CARD) system, in healthcare teams.        3. To determine if there is a synergistic effect when adding the CARD system to the use of          knowledge-based cognitive aids or indeed whether using both these tools together has          unintended consequences and reduces the added value of each technique.        4. To identify whether additional simulation-based team training in the use of cognitive          aids results in a significant improvement in performance over an e-learning module.      The investigators hypothesize that (i) knowledge-based cognitive aids will significantly     improve the performance of healthcare teams in providing PALS in a simulated setting, (ii)     that teamwork-based cognitive aids (CARD) will significantly improve the performance of     healthcare teams in providing PALS in a simulated setting, and that (iii) adding the CARD     system to knowledge-based aids will have an added and synergistic effect, (iv) that the team     performance in all study arms will improve after simulation based training, but that the     groups with cognitive aids will continue to out-perform the groups without cognitive aids.   "
46573|NCT02676011|"     Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim     of this study was to evaluate the efficacy of atropine sulfate for prevention of brad     arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.   "
46574|NCT02675998|"     This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a     4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety     and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients     on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either     receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.   "
46579|NCT02675933|"     This study is a randomized controlled trial utilizing a patient-centered questionnaire     distributed to parents of children with autism. The study arm will receive the questionnaire     and will be compared to the control arm, which will receive standard of care. The results of     satisfaction surveys will be the primary endpoint of this study.   "
46580|NCT02675920|"     The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of     bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of     HCC.   "
46581|NCT02675907|"     The primary objective of this study is to evaluate the analgesic efficacy of N1539 in     subjects with acute moderate to severe pain following unilateral bunionectomy.   "
46582|NCT02675894|"     To determine safety, ablative zone, technical success rate and early safety data of recently     introduced cool-wet electrode in eligible patients who are indicative for radiofrequency     ablation (RFA) for liver tumors.   "
46583|NCT02675881|"     Increasing ablative zone is an essential part to improve technical success and long term     outcome in patient treated with radiofrequency ablation (RFA).      A combination of dual switching system and separable clustered electrode has been reported to     create large ablative zone in preclinical study.      Based on preclinical study, the investigators conducted a preliminary study in eligible 60     patients to measure whether this combination (dual switching system and separable clustered     electrode) improves technical success rate and local tumor progression rate over a year, in     comparison with historical control group.   "
46584|NCT02675868|"     Noradrenaline is a catecholamine and the cornerstone treatment for the improvement of     hemodynamic parameters in septic shock. Catecholamines exert profound immunomodulatory     effects. Noradrenaline in vitro inhibits LPS-induced pro-inflammatory cytokine production,     however, the actions on immune function in vivo have not been assessed. Furthermore, effects     on the immune system of viable vasopressor alternatives for the treatment of septic patients,     namely phenylephrine and vasopressin, need to be established in humans in vivo.   "
46585|NCT02675855|"     The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration     to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.   "
46611|NCT02675517|"     The primary objective of the study is to measure changes in physical functioning - serving as     a surrogate for physical activity and exercise capacity - in COPD patients being treated with     Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the     patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start     of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after     visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.   "
46677|NCT02674659|"     This research will add resistance training to patients who undergo cardiac rehabilitation     program after coronary bypass surgery, comparing the level of PCSK9 level on that group to     another group who receives conventional rehabilitation program (only aerobic exercise)   "
46586|NCT02675842|"     Radiation therapy to the chest is used in late stage lung cancer, and it often leads to     inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient,     and usually begin within a week of starting radiation therapy. The esophagitis causes pain     and difficulty eating. It can also result in stopping or delaying treatment.Radiation therapy     to the chest is used in late stage lung cancer, and it often leads to inflammation of the     esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin     within a week of starting radiation therapy. The esophagitis causes pain and difficulty     eating. The endocannabinoid system is prominent in the gastrointestinal system, and cannabis     has been shown to greatly inhibit inflammation. The compound     (−)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation and pain.     Cannabidiol is a component of cannabis that does not produce subjective or intoxicating     effects, but also has prominent anti-inflammatory properties.      The goal of this study is to perform a double-blind, placebo-controlled study to investigate     the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation     Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used     , which is a cannabinoid that does not change perception or produce intoxication, and low in     Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the     possible side effects of cannabis in medically ill participants.   "
46587|NCT02675829|"     The purpose of this study is to find out what effects, a drug called ado-trastuzumab     emtansine has on the patient and their cancer which is thought to be controlled by the     abnormal HER2 gene.   "
46588|NCT02675816|"     The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper     Airway System (UAS) in a commercial setting. This study will provide additional clinical     evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA)     using a randomized controlled trial design.   "
46589|NCT02675803|"     This study will investigate the safety and tolerability of VAY736 administered as single     ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous     injections in rheumatoid arthritis patients.   "
46590|NCT02675790|"     The overall goal of the proposed study is to determine the effectiveness of hydroxyurea     therapy for secondary stroke prevention and prevention of other neurological events in     children with SCA with an acute overt stroke.   "
46591|NCT02675777|"     Alcohol use is the third greatest cause of disability and death for US adults. Care for     unhealthy alcohol use is lacking in most primary care settings. This project will implement     two types of evidence-based care for unhealthy alcohol use in the 25 primary clinics of a     regional health system—Group Health (GH). These include preventive care and treatment.     Preventive care consists of alcohol screening, and for patients who screen positive, brief     patient-centered counseling. Treatment for alcohol use disorders includes offering shared     decision making and motivational counseling designed to enhance engagement in one or more     treatment options: counseling, medications, and/or specialty treatment. During a pilot phase,     the research team at Group Health Research Institute partnered with Group Health leaders and     front line clinicians to design, pilot test, and iteratively refine an implementation     strategy in 3 Group Health primary care clinics.      Objective      This study uses state-of-the-art implementation strategies to integrate evidence-based     alcohol-related care into 22 primary care clinics (detailed below). This study is a pragmatic     stepped-wedge quality improvement trial to evaluate its impact on:        1. The proportion of patients who have primary care visits who screen positive for          unhealthy alcohol use and have documented annual brief alcohol counseling;        2. The proportion of patients who have primary care visits who have AUDs identified, and a)          initiate and b) engage in care for AUDs.      Secondary outcomes will include:        1. The proportion of patients who have primary care visits who have documented annual          alcohol screening with the AUDIT-C; and        2. The proportion of patients who have primary care visits who screen positive for severe          unhealthy alcohol use and have AUDs assessed and/or diagnosed;   "
46593|NCT02675751|"     Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.   "
46594|NCT02675738|"     Prospective, observational, cohort study to evaluate the reliability of preoperative work-up     of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral     center. A comparison between the preoperative diagnostic suspicion and the final pathologic     report will be done.   "
46595|NCT02675725|"     Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators     assume that fluid bolus will increase the delivery of oxygen to the cells and resolve the     shock.      The purpose of this study is to asses kinetics of the sublingual microcirculation in one     place during a fluid bolus. It is expected that fluid therapy after normalization of the red     blood cell flow velocity in the microcirculation will result in a decrease in capillary     density through the formation of edema in the tissues. This can be considered to be the     tipping of potentially beneficial to deleterious effects of fluid therapy.      After cardiac surgery patient will be transferred to the ICU for further stabilisation.     Within specific indications the patient will receive a fluid bolus, these indications are     hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus     will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual     microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary     vessel density on one spot during this fluid bolus.   "
46596|NCT02675712|"     This pilot study evaluated whether participating in an African drumming activity for 45     minutes immediately improved mental well-being among 13 adults diagnosed with acute mood     disorders who were attending a private mental health clinic. The drumming intervention was     completed by occupational therapists.   "
46597|NCT02675699|"     This study will test whether parent engagement (recruitment, attendance) in a Childhood     obesity prevention programme (HENRY) can be improved in local authorities randomised to     receive an Optimisation intervention (in addition to standard HENRY) compared to those     continuing to deliver the programme as standard.   "
46598|NCT02675686|"     The discovery of antenatal bilateral renal anomaly poses an essential question: can we     predict postnatal renal function in short, medium and long term? Ultrasound appears     sufficient in severe or mild forms. In the Intermediaries form (normal size dysplastic     kidneys with persistence of amniotic fluid), ultrasound and current markers do not predict     postnatal renal function evolution.      The objective of this study is to estimate the specificity and sensitivity of amniotic     biomarkers profile in the diagnosis of renal functionality in fetuses with bilateral     nephropathy development.   "
46691|NCT02674477|"     This research is being done to study whether using an Internet-based program, called the     Therapeutic Education System (TES), would be helpful for the treatment of substance use and     other psychiatric problems.   "
46599|NCT02675673|"     The purpose of this study is to compare the quality of life (QOL) in head and neck patients     who are given the GJ tube (which is placed in the bowel) versus those who are given the     G-Tube (which is placed in the stomach) for prophylactic feeding. The standard of care for     patients at Princess Margaret Hospital (PMH) is using GJ tubes. Patients who agree to be in     the study will be randomized to either the GJ-Tube or the G-Tube arm. Patients randomized to     the G-tube will receive prophylactic intravenous and oral antibiotics prior to insertion of     the G-tube. Antibiotics will be given for a total of 1 week. A few hours following tube     insertion (on return to PMH ward), patients will complete a single item, visual analogue pain     scale (VAS). Patients will remain in hospital for a minimum of 24 hours and until the patient     and/or family is able to care for the Enteric Feeding(EF) device at home. Patients randomized     to the GJ-Tube may receive i.v medication during the procedure. All Patients will be asked to     fill out several questionnaires at different time- points of the study. All Patients will     have regular assessments to evaluate their overall quality of Life, toxicity, and how they     respond to treatment during the study. Patients will also be assessed after they completed     study treatment.   "
46600|NCT02675660|"     This study represents an initial clinical evaluation of an oral formulation of     L-homoarginine. L-homoarginine and L-arginine are amino acids found in food proteins and are     both substrates for nitric oxide synthase (NOS). L-arginine is available as over the counter     nutraceutical. This study will provide information on the dosing of L-homoarginine in order     to reach high physiological plasma concentrations in humans.   "
46601|NCT02675647|"     The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established     in obese patients.      Results of a preview study show that the standard heparin management based on total body     weight in obese patients during CPB resulted in excessive heparin level, which could lead to     excessive postoperative bleeding.      To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese     patients was proposed.      The main objective of the study is to evaluate the effects of heparin injection, based on     ideal body weight, on intraoperative plasma heparin levels and activated coagulation time     (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB     surgery with heparin management based of total body weight.      The secondary objectives are to evaluate the relationship between heparin level and ACT in     each group of patients and at different time points during CPB, and to compare the incidence     of bleeding, intraoperative transfusions and complications in the two groups of patients.   "
46602|NCT02675634|"     This clinical investigation is intended to explore the performance and safety of two newly     developed ostomy products with regard to the products fit to body properties.   "
46603|NCT02675621|"     An acute, randomized, placebo controlled, double blinded crossover study in health subjects.     Participants will complete 4 intervention arms in random order consisting of a placebo     control beverage, a high dose phenolic beverage, a high dose phenolic beverage combined with     a fruit extract, and a low does phenolic beverage. The primary objective of the study is to     assess the effects of the phenolic compounds, at two different levels, alone and in     combination with a fruit extract, on mood and cognitive performance during extended periods     of cognitively demanding task performance.   "
46604|NCT02675608|"     This study evaluates the effectiveness of the seasonal flu vaccine in adults of different     ages and diabetic disease statuses. These studies will help our understanding of how chronic     inflammatory diseases impact immunologic function and future research on mitigation     strategies.   "
46642|NCT02675114|"     To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve     in patients with severe, calcific aortic stenosis who are at low operative risk for standard     aortic valve replacement (AVR).   "
46605|NCT02675595|"     Hypothesis:      In Women in the second trimester of pregnancy 5D offers an alternative method for fetal     Echocardiography compared to conventional 2D scanning      Question:      Does 5D software technology is as efficient as 2D scanning in fetal echocardiography of     second trimesteric fetuses?      Aim:      This study aims at assessing the accuracy of performance of the 5D as a new scanning     technology in fetal Echocardiography compared to the conventional use of 2D scanning.   "
46606|NCT02675582|"     The primary objectives of this study are to assess the effects of three investigational     drinks containing three botanicals in differing combinations versus a placebo control, on     mood, psychological state, physical response, and cognitive performance during and after     exposure to an observed multi-tasking stressor.   "
46607|NCT02675569|"     This pilot randomized controlled trial (RCT) is multi-center, parallel-arm, and open label.     It will test the feasibility and safety of randomizing elderly patients with end-stage kidney     failure starting hemodialysis with a tunneled/non-tunneled catheter to one of the following     vascular access strategies: (a) attempt at fistula creation (intervention), or (b) continued     use of a catheter (comparator). A total number of 100 participants will be enrolled in this     pilot RCT. The rationale for this trial includes: (1) the importance of the intervention     question related to the choice of vascular access for patients treated with hemodialysis; (2)     lack of evidence from clinical trials for decision-making in this area (only observational     studies are available); (3) existing studies which suggest that fistula use is associated     with better patient outcomes are very prone to selection bias; (4) need for a clinical trial     comparing the impact of the two most frequently chosen strategies for vascular access     (catheter and fistula) in the hemodialysis population; and (5) a feasible and safe trial     design. The results obtained from this pilot RCT will determine the feasibility and safety of     conducting a large RCT, which will be powered for the primary outcome of all-cause mortality.   "
46608|NCT02675556|"     This study is intended to evaluate the safety and potential efficacy of Allogeneic Human     Mesenchymal Stem Cell Infusion versus placebo in patients with Treatment Resistant     Depression.   "
46609|NCT02675543|"     The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery     has its apex in the development of PVR that occurs when retinal cells are exposed to the     inflammatory milieu in the humor vitreous.      This situation is common in complicated retinal detachment, but is amplified after invasive     surgery and by the use of intraocular tamponades that float over a subtle film of liquid     where the inflammatory cytokines and growth factors reach the critical concentration over the     inferior retina.      Many authors have noted that the heavy tamponade are more prone to cause intraocular     inflammation compared to standard silicone oil, especially if they remain for several months     in the eye.      The purpose of this study is to measure the vitreous concentration of some of the most     important cytokines involved in the inflammatory vitreal response.   "
46612|NCT02675504|"     Since the 2000s, the experiences of children and especially their fear during a consultation,     a treatment or examination is food for thought in our establishment. There is no tool     validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create     this tool. The scale self-assessment of the fear that we have developed consists of six faces     representing a gradual level of fear: the child can easily describe their level of fear,     which allows for appropriate care.   "
46613|NCT02675491|"     This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of     DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or     NTRK fusion gene.   "
46614|NCT02675478|"     This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of     quizartinib for Japanese acute myeloid leukemia (AML) subjects.   "
46615|NCT02675465|"     This study is an international, multi-center, study of Pompe disease patients that are     currently receiving enzyme-replacement therapy (ERT). The purpose of this study is to find     out if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults     with Pompe disease.   "
46616|NCT02675452|"     At least one dose level of AMG 176 will achieve acceptable safety and tolerability in     subjects with relapsed or refractory multiple myeloma   "
46617|NCT02675439|"     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics,     pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral     injection.   "
46618|NCT02675426|"     This is a multi center, randomized, double-blind, placebo-controlled phase 3 study in     subjects with moderately to severely active rheumatoid arthritis on a stable dose of csDMARDs     who have had an inadequate response to csDMARDs.   "
46619|NCT02675413|"     This is a prospective study that will explore the mechanisms of efficacy of dimethyl fumarate     (DMF) treatment in multiple sclerosis (MS). Investigators will enroll relapsing MS patients     who are beginning therapy with DMF into a one-year longitudinal study in which blood and     spinal fluid analyses, imaging and clinical studies will be performed to identify and measure     changes associated with DMF therapy.   "
46620|NCT02675400|"     In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of     paternal ADHD in families and children with ADHD symptoms has not been studied, despite the     prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on     treatment on the family and child, and effects of treating fathers relative to mothers with     ADHD. Paternal ADHD is associated with negative parenting and child conduct problems.      The investigators hypothesize that successfully treating parental ADHD in fathers will have a     beneficial effects on the family that will extend to the child. Specifically, the     investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD     medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and     improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral     Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who     have children between the ages of 3 -8.      As in the investigator's previous work, the investigators will bank paternal and child DNA     and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of     stimulant response.   "
46670|NCT02674750|"     This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety     of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse     Large B-Cell Lymphoma (DLBCL).   "
46621|NCT02675387|"     Children in their seventh year of life (age range of 6 to 7 years) will be included in the     study. All children included in the study would have to classified according to the Wright     behavior classification as potentially co-operative and rated as per the Frankl behavior     rating scale as positive (++) Group A and negative (-) Group B . All children included must     have had no prior experience of dental anesthesia and must have at least one tooth requiring     restorative procedure on either side of the maxillary arch. Intervention Description        1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary          arch as is commonly practiced in dental clinics. Information obtained before assignment          of intervention or standard care included age, gender, type of injection given alongside          the vibration device will be recorded beforehand. During the delivery of anesthesia for          all the groups, anticipated and actual pain will be recorded to show the impact of          anxiety on the experience of participants. During the entire process, all participants          will use standard needles with confirmed specification to control for any potential          confounders        2. Buzzy® The use of the external cold and a vibrating Device will follow the          manufacturer's recommendations to ensure that normal clinical scenario is created.   "
46622|NCT02675374|"     This single-institution randomized controlled trial prospective will enrolled 48 patients     scheduled for an aortic valve replacement. The objective of the present investigation is to     determine the role of Polaramine® on reducing hemodynamic instability after separation from     cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play     an important role reducing dysfunction of the autonomic nervous system and hemodynamic     stability after separation from CPB.   "
46623|NCT02675361|"     This study is part of a larger research project known as Swedish Transition Effects Project     Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created     to develop and evaluate transition programs in order to support adolescents with chronic     conditions in Sweden. While STEPSTONES has a generic nature, the first transition program     that will be evaluated targets adolescents with congenital heart disease (ConHD).      This particular study involves a hybrid experimental design, meaning a randomized controlled     trial is embedded in a longitudinal, observational study. This type of design will help to     test the effectiveness of a transition program in order to empower adolescents with     congenital heart disease in the transition to adulthood and check for potential contamination     of the comparison group. We will recruit 210 participants: 140 adolescents will be part of     the randomized controlled trial (70 in the intervention arm; 70 in the comparison arm), and     70 participants will be assigned to the observational, longitudinal arm of the study, which     serves as control group in an intervention-naive center. Over a period of two years, three     assessments will be done during which all participants will be asked to answer a set of     questionnaires.      The intervention to be tested involves patient empowerment, education on their ConHD, dealing     with school, health behaviors required to maintain good health, guidance of parents, a     person-centered transition plan, among others. The study hypothesis is that adolescents with     ConHD who received a structured, person-centered transition program over a 2-year period have     a higher patient empowerment score than adolescents who receive usual care.   "
46624|NCT02675348|"     The aim of this project is to investigate the potential benefits of combining a new protein     beef hydrolysates extract with a regular endurance training programme on (a) body composition     (b) performance (c) muscle structure (d) blood markers of health in athletes. As a second     objective the investigators will analyse potential differences obtained from the ingestion of     the new hydrolysates beef protein extract compared to the ingestion of others commercially     available protein sources such as whey and non protein only carbohydrate contrast nutrients.   "
46625|NCT02675335|"     The purpose of the study is to test the effect of Sitagliptin on the healing of stable,     nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.   "
46626|NCT02675322|"     Danlou tablets are Chinese patent medicine which has been approved in China for the treatment     of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling     remains unclear. This pilot study was designed to determine whether Danlou tablets reduced     adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI).     Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g     q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI.     Major end points were changes in LV volumes and ejection fractions as evaluated by serial     echocardiography in addition to clinical outcomes were also determined.   "
46627|NCT02675309|"     The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of     simvastatin and rosuvastatin in healthy subjects.   "
46628|NCT02675296|"     Acute kidney injury requiring dialysis (AKI-D) has increased considerably over last 15 years.     The national rise in incidence of acute kidney injury has several ramifications in terms of     cost to the health services resulting not only from cost of therapy but also from the later     consequences of AKI from development of chronic kidney disease and cardiovascular disease.     Mortality in patients with AKI-D is very high and remains unchanged in the last decade in     England. In recent years it is becoming clearer that even the national incidence and     case-fatality of AKI is influenced by regional variation. In last three decades, many studies     have reported unwarranted variation in a wide range of procedures, from the performance of     cesarean section and coronary angiography to the treatment of early prostate cancer, stroke,     and the ailments of the chronically ill. In surgical care there is evidence that the     variation may be driven by forces other than patient illness and medical appropriateness such     as access to care and other socioeconomic factors, provider capacity of the local system,     medical malpractice pressure, and distinctly different local practices. Despite the public     health burden of AKI-D in England, it is unclear if regional variation exists in AKI-D.     Variation in incidence of AKI-D in different region of a country may be influenced by patient     and physician demographics of the regions, physician preferences or the nature of the     hospital serving the population. To reduce the incidence and case fatality of AKI-D, it is     imperative to understand if variations in incidence and case-fatality in AKI-D exists in     different regions of the country.      To address this gap in knowledge, the investigators combined national database of hospital     admissions and discharge with census data from office of national statistic over a period of     fifteen years to determine the trend in change in the regional incidence and case fatality of     AKI requiring dialysis in England. The investigators also explored various determinants of     the regional variation in the dialysis requiring AKI.      Methods Data source The investigators extracted 2000-2015 data from the Hospital Episode     Statistics (HES), a data warehouse containing details of all admissions, outpatient     appointments, and A&E attendances at National Health Service (NHS) hospitals in England.      Definitions The investigators identified all cases of AKI by using validated International     Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in any     diagnoses codes, in keeping with the objective of the study. Patients with any of the     following codes were included: N17.0 for acute renal failure (ARF) with tubular necrosis,     N17.1 for ARF with acute cortical necrosis, N17.2 for ARF with medullary necrosis, N17.8 for     other ARF and N17.9 for ARF, unspecified. ARF has been replaced by new terminology, AKI, but     due to lack of ICD10 codes for AKI, the investigators used the ICD10 codes for ARF and     henceforth, will be referred to as AKI in this study. The investigators also extracted all     available secondary diagnosis and up to 24 Office of Population Censuses and Surveys     Classification of Interventions and Procedures, 4th revision (OPCS-4) codes. To identify     patients with AKI-D, the investigators included OPCS code of X40.3 for hemodialysis or X40.4     for hemofiltration in any of the 25 procedures. Patients with chronic kidney disease stage 5     (CKD-5) starting chronic dialysis and end stage renal disease (ESRD) with ICD-10 code of     N18.5 and N18.6 respectively were excluded. The investigators also excluded OPCS-4 codes for     Arteriovenous fistula (L74.2) or Arteriovenous graft (L74.3) during the inpatient admission.     HES data stratifies patient location into 16 different regions. The geographic regions in     England were stratified as per the Office of National Statistic (ONS) into nine regions:     North East, North West, Yorkshire and Humber, East Midlands, West Midlands, East of England,     London, South East and South West. Patients' in geographical locations outside these nine     regions were excluded. Patients who were admitted, but were not discharged during the study     period will not be included in the study. The investigators also obtained completed hospital     discharges from each region to estimate the effect of hospitalization on AKI-D incidence     rates, along with number of nephrology consultants in each region from 2000 to 2015 from     Health and Social Care Information Centre (HSCIC) in the annual census of medical and dental     staff in the NHS. The investigators will also obtain linkage with ONS and UK Renal Registry     (UKRR) for long-term patient and renal outcomes. To obtain population incidence of AKI-D for     each region, mid-year population of the region in each year from 2000 to 2015 was obtained     from the ONS.   "
46629|NCT02675283|"     This study aims to assess whether it is feasible to use a point of care test to increase the     detection of coeliac disease in a pharmacy setting.   "
46630|NCT02675270|"     The goal of this study is to remediate word-finding problems in patients with Primary     Progressive Aphasia (PPA) and to delay the further progression of word-finding impairment.     The current approach is novel in that it contains a prophylaxis component in which the     investigators attempt to strengthen neural connections that remain functional, making them     more resistant to degradation as the disease progresses. While the study is specific in its     targeting of word-finding problems, a successful outcome would bode well for other studies     aimed at prevention or reversal of declining cognitive functions in dementia. Patients with     PPA whose naming of pictures has just begun to show signs of decline will receive practice     with picture naming in two conditions: viewing the picture and repeating the name; and     viewing the picture with its written name, plus reading and writing the name. Naming of     pictures trained in each of these conditions will be compared, at three time intervals     post-training, with naming of pictures tested before the study but never trained. A     scene-description task containing trained items will be used to assess generalization. It is     predicted that the pairing of the picture with its written name, combined with the motor task     of writing the name, will result in a greater ability to name the picture at a later date     than simple practice viewing the picture and repeating the name. Generalization to other     exemplars and to other task situations is also predicted.   "
46685|NCT02674555|"     This is a study to investigate the absorption, metabolism and excretion of [14C] labeled     ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This     study consists of two parts (A and B).   "
46631|NCT02675257|"     This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes     patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes     distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c).     Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care     behaviour, diabetes acceptance and quality of life. The treatment group will be treated with     a cognitive-behavioural group treatment comprising specific interventions to improve     glycaemic control and reduce diabetes distress as well as depressive symptoms. The control     group will receive treatment-as-usual. A total of 212 study participants will be included. A     secondary study objective is to analyse associations of suboptimal glycaemic control,     depressive symptoms and diabetes distress with inflammatory markers.   "
46632|NCT02675244|"     The purpose of the research is to determine whether repairing a tricuspid valve (TV) in     patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral     valve surgery (MVS), would improve the heart health of those who receive it compared to those     who do not.      At this point, the medical community is split in their opinion on whether surgeons should     routinely repair mild to moderate TR in patients who are undergoing planned mitral valve     surgery, and this study will answer this question.   "
46633|NCT02675231|"     The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab     with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+),     human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic     breast cancer after prior exposure to at least two HER2-directed therapies for advanced     disease.   "
46634|NCT02675218|"     Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying     antirheumatic drugs (DMARDs).      Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis,     biomarkers of inflammation, and bone destruction.      Given the demonstration of correlation between joint inflammation and structural progression     at each joint level as well as the opportunity for bone remodeling with resolution of joint     inflammation, researchers expect to observe an improvement in bone micro-architecture     parameters specifically in rheumatoid arthritis patients without remaining joint inflammation     3 months following abatacept treatment initiation.   "
46635|NCT02675205|"     Part of interventional neuroradiology procedures for the treatment of selected cerebral     aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet     therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3     of the patients are low responders due to variation of the biological response to clopidogrel     . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled     trial. It could be an option for APT due to more reproducible response with less     interindividual variability and reduced monitoring. The aim of this study is to demonstrate     the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing     neurovascular stenting for cerebral aneurysm.   "
46648|NCT02675036|"     The purpose of this study is to see whether extraction of the primary canine tooth or     extraction of both the primary canine - and the primary first molar tooth is most effective     in the treatment of palatally ectopic canine teeth in the maxilla. In addition the study will     also measure pain and discomfort in relation to these two treatment alternatives.   "
46636|NCT02675192|"     Aging affects almost all the tissues and physiological functions, and skeletal muscle is the     most affected organ. The progressive decline of the weight and the muscular function linked     to the aging contributes to the lack of autonomy and dependence, but also to an increase of     the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in     13-24% of 60 years old, and 50% of 80 years old and more.      However, strong inter-individual variations of this prevalence of sarcopenia exists. The key     issue is to understand why the biological aging of the skeletal muscle is so different     between people.      In this study, mechanisms involved in biological aging of the skeletal muscle in aging people     (same chronological age) will be specified.   "
46637|NCT02675179|"     The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and     the spiral CT in women having had an obstructed delivery. If this concordance is     demonstrated, it would allow the use of this new technique of imagery, to realize a     pelvimetry during the pregnancy less irradiating for the mother, and the fetus.   "
46638|NCT02675166|"     Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is     estimated as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical complications     can lead to a late risk of death. A regularly support, a therapeutic education, a support of     the psychological difficulties have a positive impact on the quality of life and on long-term     health for patients surviving to a cancer.      The ARCERRA exists, registering around 150 new cases a year. They coordinated, from 2011 to     2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients     diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility and     utility for patients and their physicians of a long-term follow-up coupled with an interview     with a psychologist in Rhône-Alpes-Auvergne.      The primary objective of SALTO-2 project is to know the becoming of young adults that     survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second     objective is in one hand to study the psychological becoming and on another hand, to     ameliorate their lifestyle thanks to different documents created specially for them.   "
46639|NCT02675153|"     Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical     rate. The present clinical trial aims to evaluate the efficacy and safety of sirolimus in the     treatment of stricturing Crohn's Disease.   "
46640|NCT02675140|"     The present study is intended to supplement the preschool anemic children with vitamin A     capsule and de-hookworm administration in poverty Sichuan province. We eventually expect our     study can provide a cost-effective, safe and more beneficial public health strategy to manage     the anemia status of preschool children in poverty area.   "
46641|NCT02675127|"     An open label randomized, single dose, two-way crossover bioequivalence study to determine     the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European     Egyptian Pharmaceutical Industries, Egypt) versus Daklinza 60 mg tablets (Bristol-Myers     Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition   "
46643|NCT02675101|"     Persistent organic pollutants (POPs) are mostly fat-soluble halogenated chemicals with very     long half-lives. POPs are endocrine disruptors, associated with increased risk for diabetes,     alterations in thyroid function, and cardiovascular disease in humans. POPs concentrations     increase with age because of their persistence, bioaccumulation and poor excretion. The     almost ubiquitous presence of endocrine disrupting POPs in US adults is a substantial public     health concern, particularly because there is no established treatment to reduce body     concentrations of POPs. Most POPs are excreted in bile due to their lipophilic nature.     However, a substantial amount is reabsorbed in the small intestine and returns to the blood     stream (entero-hepatic circulation). The objective of this pilot study is to conduct a     6-month randomized controlled trial of Nuts and Olestra to enhance the excretion of POPs     among 45 healthy adults aged 45 to 70 years with BMIs between 18-30 kg/m2. This study has 3     treatment arms: A) Whole nuts with high fat content (almonds and walnuts; 110g total/day,     n=15), B) Olestra: Fat Free PringlesTM potato chips (≈29 crisps, 18g of Olestra/day; n=15),     C) Vegetable oil: Original PringlesTM potato chips (≈29 crisps, 17.4g of oil/day; n=15). The     investigators aim to measure change in concentrations of 24 POPs in feces after 4 days of     treatment and in blood at 6 months.   "
46644|NCT02675088|"     Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy,     and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study     recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could     improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But     intrathoracic progression was still high, either with or without progression elsewhere,     occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe     higher dose can provide better local control(LC) and overall survival. In this study, the     investigators propose to give an increased dose of TRT to determine whether higher dose will     improve 2-year OS, LC and progression-free survival.   "
46645|NCT02675075|"     A disease called Amyotrophic lateral sclerosis (or ALS), which leads to difficulty     swallowing, breathing, and movement, has been found to be higher for those serving in the     military than in the general population. There are approximately 4,200 Veterans with ALS and     roughly 1,000 new cases each year. When doctors attempt to determine the degree to which an     ALS patient is suffering from the disease, they apply tests that are graded by experts.     However, this approach to testing patients may not be very accurate. Researchers aim to use a     system called DESIPHER to listen to ALS patients and find speech mistakes related to their     condition. Researchers believe that, by detecting different types of errors, DESIPHER serves     as a new kind of indicator of medical problems such as difficulty breathing or swallowing,     without human grading. This may also lead to a better system for automatically     understanding ALS patients' speech.   "
46646|NCT02675062|"     The purpose of this study is to determine whether habitual physical activity and sedentary     behaviour improve six weeks and between three to six months after total knee replacement     surgery in people with osteoarthritis.   "
46647|NCT02675049|"     This trial is going to evaluate the safety and effectiveness of intranasal     DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the     optimal dose of intranasal DEX in breast lumpectomy.   "
46653|NCT02674971|"     For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One     dietary strategy that may facilitate reducing energy intake and enhancing weight loss is     consuming a diet low in dietary energy density (ED). The ED of a given food, defined as the     ratio of energy of the food to the weight of the food (kcal/g), is largely determined by     water content, but is also affected by fat and fiber. Although the 2010 Dietary Guidelines     encourage an eating pattern low in energy density (ED) to manage weight, it is currently not     known what the best strategy is for reducing ED in the diet. Eating a greater number of foods     low in ED or reducing the number of foods high in ED may reduce overall dietary ED. As ED is     believed to reduce intake by allowing a greater weight of food relative to total energy     consumed assisting with enhancing feelings of fullness, it is anticipated that either     increasing consumption of low-ED foods in the diet alone or combining an increase in     consumption of low-ED foods with a decrease in consumption of high-ED foods may be the best     strategies for reducing overall dietary ED for weight loss.   "
46654|NCT02674958|"     Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of     endothelial progenitor cells (EPCs).   "
46655|NCT02674945|"     This project attempts to correlate wireless activity data with quality of life and sleep     surveys in order to find a new method of monitoring patients during their treatment.   "
46656|NCT02674932|"     Research has shown that identifying and using one's character strengths in new ways decreases     depressive symptoms and increases happiness in adults in the general population. Recently, we     found that a similar intervention increases the self-esteem and self-efficacy of children and     adolescents being treated in an inpatient psychiatric unit. The purpose of this study is to     better understand the effects that discovering one's character strengths and incorporating     them into coping skills will have on treatment outcomes in patients admitted to a child and     adolescent inpatient psychiatric unit.   "
46657|NCT02674919|"     The purpose of the study is to investigate the efficacy of a 10-week intervention, using the     Nordic Hamstring exercise, on repeated-sprint ability in male sub-elite football players. The     primary outcome measure is total sprint time during 4x6 sprint of 10 meters measured using     dual-beam photoelectric cells. Additionally, eccentric knee flexor strength is measured using     the Nordbord hamstring strength measure. The hypothesis is that strength training of the knee     flexor muscles elicited by the Nordic Hamstring exercise will result in enhanced repetitive     sprint-ability expressed as a decrease in total sprint time. Furthermore, baseline data is     used to assess to correlation between eccentric hamstring strength and active hamstring     flexibility AND sprint performance.   "
46658|NCT02674906|"     The primary aim of this randomized controlled study is to determine whether the use     Anticoagulant Citrate Dextrose Solution--Formula A (ACD-A) in cell salvage reduces     inflammation and oxidative stress in cell saver blood compared to heparin. The secondary aim     is to determine whether any differences in activation can be correlated to any differences in     postoperative clinical outcome.   "
46659|NCT02674893|"     This is an open-label comparative study in three parallel groups. It is expected that 90     patients and/or healthy volunteers will participate in this biomedical research.      Distribution in groups        -  30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue          (group 1)        -  30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins          (group 2)        -  30 healthy subjects (non-diabetics) (group 3)      This study will investigate modifications in eating behaviour induced by Liraglutide in     patients who start treatment with Victoza® and certain aspects, such as liking (hedonic     characteristic of a food), wanting (desire to eat a given food) and salivation in response to     the presentation of a food by taking measurements at D0 (before initiation of the treatment     with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months     and 9 months (only for controls).   "
46660|NCT02674880|"     The objective of this study is to test the effect of HMW-HA on NIV effectiveness in patients     admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of     COPD.   "
46661|NCT02674867|"     The study aims to define and compare the immunological characteristics (lymphocyte     subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory     parameters) and the virological characteristics (study of viral reservoir) between 2 groups     of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before     6 months-of-age (early treatment group) or after 24 months-of-age (late treatment group)     with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months     after the start of cART), whatever the later evolution of the viremia.      Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each     group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures     <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study     of the inductibility of the viral reservoir.   "
46662|NCT02674854|"     To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to     netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%   "
46663|NCT02674841|"     This study investigates if live feedback during home-based exercises will improve the ability     to perform the exercises with the prescribed time under tension (TUT) per repetition compared     with no feedback among adolescents with patellofemoral pain. The hypothesis is that     adolescents who receive live feedback from BandCizer™ will have a mean TUT that is     significantly closer to the prescribed TUT compared to the group not receiving feedback     during the course of the intervention.   "
46664|NCT02674828|"     The purpose of this pilot study is to evaluate the initial efficacy of a reinforcement     intervention to enhance physical activity levels in sedentary adolescents and young adults     with type 1 diabetes (T1D). The intervention will reinforce patients for meeting physical     activity goals, with escalating reinforcers provided when patients achieve continuous weeks     of meeting goals. A 12-week trial will be conducted in which 60 patients will be randomized     to: (1) standard care or (2) standard care plus reinforcement.   "
46720|NCT02674100|"     The purpose of this study is to create a registry to provide insight into treatment selection     and treatment outcome of pancreatic IRE in order to develop an evidence base such that     physicians can provide the best possible care to patients with pancreatic cancer requiring     surgical interventions.   "
46665|NCT02674815|"     Colorectal and thoracic surgical patients are susceptible to poor postoperative outcome     including complications, mortality and increased length of stay. Preoperative physical     fitness is protective against poor postoperative outcome in intra-abdominal and thoracic     surgery.      The current colorectal/thoracic pathway from diagnosis to surgery is about 2 weeks and     therefore interventions of longer duration are not feasible. Clinicians may be presented with     a difficult choice in delaying surgery to perform prehab or cancel the pre-op intervention.      To create greater improvements in aerobic fitness, participants are required to exercise at     high levels of VO2peak (e.g. ≥80% VO2peak). High intensity interval training (HIIT) requires     participants to exercise at high levels of VO2peak (≥80% VO2peak) for short periods (e.g. 15     seconds) followed by a recovery (active or passive) and typically continue this pattern for     30 minutes or until exhaustion.      HIIT programmes are safe and a recent meta-analysis noted that HIIT produced a more     pronounced incremental gain in participants' mean VO2peak when compared with continuous     moderate intensity exercise (+1.78mL/kg/min, 95% CI: 0.45-3.11).      HITT has not been investigated as a preoperative intervention to either optimize fitness     prior to surgery or reduce post-surgical complications. Preoperative HIIT is an intense     intervention which will require significant participant adherence. The safety, cost and     clinical application of such a programme needs to be performed. This feasibility study aims     to assess the ability of HIIT to improve aerobic fitness two weeks prior to surgery and     determine its feasibility.   "
46666|NCT02674802|"     Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and     gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection     rates of Helicobacter pylori is still high, so effectively eradication is necessary. At     present, the eradication therapy has achieved very good curative effect. However, relapse     after eradication is unoptimistic. This study has made an analysis for reinfection after     eradication of Helicobacter pylori Infection include the retrospective and prospective     studies, aims to explore the epidemiological data and related risk factors of Hp reinfection     in China.   "
46667|NCT02674789|"     Ionized magnesium variation is measured during a normal day and again during a day with an     exercise protocol of 90 minutes.   "
46668|NCT02674776|"     This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients     with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule     treatment group and Placebo control group. Randomization codes were established by the     biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of     VAS score from baseline, proportion of improvement with damp-heat retention, change in     C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in     white blood cell count in whole blood cell analysis from baseline, and the number of adverse     events will be monitored and compared between each groups.   "
46669|NCT02674763|"     This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and     RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive     disease.   "
46671|NCT02674737|"     To evaluate the efficacy and safety of appropriate postoperative sedation with     dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was     conducted from October 2015 and December 2015 among patients after gastrectomy. The     investigators are going to enroll patients who received abdominal surgeries. One group     receive sedative along with analgesic and the other group analgesic only for the other group     on the first 24 hours after surgeries and follow up for 3 days.   "
46672|NCT02674724|"     To investigate if resistance training exercises performed twice a week with or without gym     equipment assistance in a 12-week period could improve balance in patients with Parkinson     Disease (PD).      Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and     preserved cognitive function will participate in this study. Patients will be randomized     among three intervention groups: resistance training with free weights, resistance training     with gym equipment and control group. Investigators will use static platform balance     variables to assess the primary end-point outcome measures. For the secondary outcomes     measures, most common clinical functional balances tests for PD will be applied: Berg Balance     Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and     variables from dynamic posturography.   "
46673|NCT02674711|"     The purpose of this project is to assess the impact of an educational video on the use of     prescription opioid medication during a 6-month period following spine surgery. Subjects will     be recruited from the pool of patients coming in for the pre-operative appointment prior to     spine surgery. Patients that consent and enroll will be randomized to receive either a brief     educational video at this appointment or usual care. Patients will be followed after surgery     weekly for the first month, and then again at 6 months to determine their prescription opioid     medication utilization patterns. Prescription data will also be pulled from electronic     medical records.   "
46674|NCT02674698|"     Objectives: The purpose of this proposal is to evaluate the impact of the CNH Dashboard     implementation on the quality of VA Purchased CNH care relative to other CNH facilities, and     to evaluate the quality of Veteran-specific care in purchased CNH facilities by transition     and safety outcome measures derived from Veteran-specific CMS data.      Methods: The investigators will evaluate the effect of the CNH Dashboard release in a     randomized, stepped-wedge dissemination. This dissemination design allows us to determine the     impact of the CNH Dashboard on the quality of purchased CNH facility more systematically than     a single phase roll-out. In each of the 4 steps, The investigators will release the CNH     Dashboard to a randomly selected set of VISNs. Dashboard release will be accompanied by     education.      Findings: The CNH Dashboard has actionable information to leaders in GEC at the local,     regional, and national levels.      Impact: When completed, this program will improve the quality of care Veterans receive in VA     purchased CNH programs as demonstrated by improved selection of CNH facilities and     Veteran-specific measures.   "
46675|NCT02674685|"     Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under     general clinical practices.   "
46676|NCT02674672|"     To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter   "
46678|NCT02674646|"     The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment     parallel to radiation therapy in oncological patients. The trial is designed as a two-armed     trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be     applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy,     thereafter weekly until the end of radiotherapy; the follow-up visits include clinical workup     as well as questionnaires.   "
46679|NCT02674633|"     The purpose of this study is to evaluate the effects of videogame-like digital therapies on     attentional functioning and symptoms in children diagnosed with ADHD.   "
46680|NCT02674620|"     A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of     continued mental and physical rest to minimize symptoms. However, this conservative approach     does not consider the pathophysiological mechanisms and neurological subsystem dysfunction     which mediate persistent signs and symptoms. Recently, developing research is recommending     targeted therapies for specific post-concussion disorders (physiologic, vestibulo-ocular and     cervicogenic). The Buffalo Concussion Treadmill Test (BCTT) is a graded aerobic test that has     emerged as safe, reliable, and effective in distinguishing between post-concussion syndrome     sub-types, quantifying physiological recovery, and guiding return to play decision making. It     has been proposed that the results of a BCTT can be used to prescribe progressively     intensifying whole body aerobic exercise (such as walking or biking), maintained at a     sub-symptom threshold, to improve autoregulatory function with the potential to improve PCS     symptoms. Positive results with BCTT have now made it the standard of care at the University     of Buffalo Concussion Clinic and Pan Am Clinic during the management of sport related     concussions. Despite its increased use in patients with post-concussion syndrome there is     currently no data on the use of exercise treatment in the early stages of concussion     recovery.   "
46681|NCT02674607|"     The aim of this study is to evaluate the possible immunologic effects of spirulina in     children with beta thalassemia.   "
46682|NCT02674594|"     The overall objective of this proposal is to execute a real-world database analysis to     evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF)     patients in the U.S      Primary objective: To determine the proportions of NVAF patients with bleeding-related     hospital readmissions that occur within 30 days of the hospitalization of NVAF patients     treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or     warfarin in the inpatient setting      Secondary objectives:        -  To determine the cost associated with bleeding-related hospital readmissions that occur          within 30 days of the hospitalization of NVAF patients treated with dabigatran,          rivaroxaban, apixaban or warfarin in the inpatient setting        -  To determine the proportions of NVAF patients with all cause hospital readmissions and          the associated costs that occur within 30 days of the hospitalization of NVAF patients          treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.   "
46683|NCT02674581|"     An oral dose in healthy and renally impaired subjects to determine the drug effect for     BMS-663068.   "
46684|NCT02674568|"     The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a     third-line and later treatment for subjects with relapsed or refractory delta-like protein 3     (DLL3) expressing small cell lung cancer (SCLC).   "
46686|NCT02674542|"     Women who have experienced a stillbirth or neonatal death are at higher risk of repeated poor     neonatal outcomes if they have short interpregnancy intervals. Understanding the attitudes     surrounding future fertility and contraception in this population is critical to propose     socially and culturally acceptable interventions to address an unmet need for family     planning.      Participants: Women who have experienced a stillbirth or early neonatal death will be     recruited from the postnatal ward of Bwaila Maternity Hospital in Lilongwe, Malawi.      Procedures (methods): This will be a qualitative study using 20 in-depth interviews and four     focus group discussions of up to 10 women each.   "
46687|NCT02674529|"     The proposed work aims to examine the neural changes associated with fast-acting     antidepressant treatments in order to develop imaging-based biomarkers of treatment response     for depression.   "
46688|NCT02674516|"     This study investigates the relationship between prefrontal cortex activity and antisocial     and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized     controlled trial, participants will undergo three sessions of anodal transcranial direct     current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete     survey and laboratory measures assessing antisocial behavior and risk factors. Heart rate and     skin conductance will also be measured.   "
46689|NCT02674503|"     After hospitalization, many older adults experience more difficulty getting around in the     community and performing one or more of their basic activities of daily living (ADLs) like     bathing or dressing. The goals of this study are to test the effectiveness of a mobility     intervention, compared to usual care, on change in mobility after hospitalization, to     determine the impact on one-year outcomes such as nursing home placement and to identify     which Veterans benefit the most from the intervention. Ultimately, the goal is to improve     recovery after hospitalization and reduce disability in hospitalized Veterans.   "
46690|NCT02674490|"     The investigators will study the effects of transcranial direct current (tDCS) stimulation     during language therapy for naming in individuals with aphasia in the acute and subacute post     stroke period. Naming difficulties are a persistent and common symptom in aphasia after     left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the     mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS)     is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful     electrical stimulation of the brain which modulates cortical excitability by application of     weak electrical currents in the form of direct current brain polarization. It is usually     administered via saline-soaked surface sponge electrodes attached to the scalp and connected     to a direct current stimulator with low intensities. Most studies are conducted in the     chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is     reason to believe tDCS might be most effective in the acute-subacute period. However, only     two studies have evaluated tDCS paired with language therapy in group studies of acute to     subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no     studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post     stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the     investigators will evaluate whether tDCS combined with SALT improves naming in individuals     with aphasia in the acute and subacute post stroke period, more than SALT alone in a     randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis     that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated     with greater gains in accuracy in naming pictures, compared to sham combined with the same     computer-delivered SALT in post stroke aphasia.   "
46692|NCT02674464|"     The investigators refined research aim is to determine if a clinic-based collaborative care     team, including a community health worker (CHW) to deliver community-based contextualized     care, reduces disparities in blood pressure control rates, lowers cardiovascular disease     (CVD) risk, and improves outcomes among patients with hypertension and other common comorbid     conditions when compared to standard of care health system approaches to CVD risk management,     including audit and feedback and staff and provider training.      Collaborative care includes care coordination and care management; regular and proactive     monitoring and treatment to target specific patient needs using validated clinical tools and     rating scales; and regular systematic caseload reviews by the care team and consultation with     experts for patients who do not show clinical improvement. A typical collaborative care team     includes the primary care provider, nurse care manager or coordinator, PharmD, clinical     social worker, nutritionist, and other members of the clinic staff involved in patient care.      Intervention protocols will be designed to address common comorbidities (diabetes,     hyperlipidemia, depression and coronary heart disease), lifestyle factors (dietary intake,     physical activity, and smoking) and medication adherence. The investigators intensive     intervention will treat the whole patient, driven by individual patient goals and     priorities, as opposed to the standard of care, which typically focuses on individual     conditions. This proposed study responds directly to patient desires to feel more equipped to     be involved in their care and manage multiple conditions that contribute to CVD. The     investigators have worked successfully in the past with a broad range of stakeholders,     including community members, patients, providers, and payors, and will continue to engage     them through the research and dissemination process.   "
46693|NCT02674451|"     Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of     coronary angiography, occurring in 10-50% of cases. As would be expected, the incidence of     CIN is much higher in patients with underlying renal dysfunction. Multiple trials have found     CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year     mortality in patients with coronary artery disease. Intravenous contrast dye is felt to cause     renal ischemia as the mechanism of injury. Unfortunately, despite the significant morbidity     and mortality with CIN, there are few therapeutic interventions to reduce the risk with the     exception of hydration and high dose statin therapy. Recently, remote ischemic     preconditioning (RIPC), a process of inducing transient arm ischemia by inflating a blood     pressure cuff to 200 mmHg for 3 repetitive 5 minute cycles, leads to a systemic     cytoprotective response and ultimately reduces ischemic renal injury, myocardial injury, and     even cerebral injury following coronary bypass grafting. While there is significant data     supporting the role of RIPC in reducing systemic ischemic injury in surgical patients, there     is only one small trial studying RIPC in patient's undergoing coronary angiography. The     investigators hypothesize that RIPC will reduce the incidence of contrast-induced nephropathy     in patients with baseline renal dysfunction undergoing coronary angiography for stable or     unstable coronary artery disease.   "
46694|NCT02674438|"     Heart failure is a condition where the heart pump does not function normally causing the     lungs to become congested. The primary symptom of heart failure is shortness of breath, and     this often leads to patients visiting the emergency department for care. Decision-making in     the emergency department is a high-stakes situation, where there is a need for decision     support to guide clinicians to make better decisions about admission to hospital or discharge     home. Many low-risk patients who could potentially be managed at home are admitted to     hospital whereas some patients who are thought safe to discharge are actually high risk and     will have adverse outcomes if they are discharged home from the emergency department.      In this trial, the investigators will study a new strategy for heart failure care, comprised     of a computer algorithm to help doctors make decisions in the emergency department about the     risk of their patient. For low-risk patients who are discharged home from the emergency     department or after a short hospital stay, patients will be referred to a rapid follow-up     clinic where the heart specialist team will rapidly assess and treat patients.   "
46695|NCT02674425|"     Conventional dark-adaptometers are unsuitable as a mass screening tool due to their high     cost, lack of easy portability, need of trained staff and a totally dark room to be operated,     arbitrary testing procedures, associated time waste in clinic and patient burden to mention a     few. Consequently, dark adaptometers are not routinely used as clinical tools for retinal     diagnosis and monitoring despite the inherent benefits over other visual electrophysiology     equipment such as the ERG system, whose cost and features may often be surplus to     optometrists' requirements.      This trial will assess the dark-adaptometry testing performance of a novel light-emitting     system by generating full dark-adaptation threshold functions in normal adult healthy     volunteers.      The novel system has been proposed to overcome the issues associated with current     instrumentation; it is semi-automatic and easy to use without the need of any skilled     operator.      It is envisaged that this system could spread the practice of dark-adaptometry testing and     its adoption by high-street optometrists. This will allow diagnosing a number of retinal     pathologies more quickly and more reliably that, faced with an ageing population, represents     a major asset to the Health Community and the NHS.      This trial will involve 20 healthy volunteers, distributed in equal number in 2 groups of     18-40 and 50-70 years old, respectively. Proven the good health and eye condition of the     participants, one of their eyes will be randomly-allocated and undergo dark-adaptometry     testing 3 times on separate days within 3 weeks.      Testing will clarify whether by using the novel system it is possible to reproduce     state-of-the-art threshold measurements as good or better than those produced by     commercially-available dark-adaptometers. Threshold measurements in the elderly will be     compared with literature data adjusted to exclude aged crystalline lens and pupillary miosis     contributions. Data variability and system usability will be also assessed.   "
46696|NCT02674412|"     This study evaluates the utility of buspirone in patients who have a diagnosis of functional     dysphagia. All participants will be randomized to receive either a placebo pill or buspirone.     Subsequently, we will evaluate whether their swallowing is improved. Participants who were     randomized to receive placebo will then receive buspirone and those who were receiving     buspirone will receive placebo. We will again evaluate whether their swallowing improved.   "
46697|NCT02674399|"     This study is a double-blind, randomized, controlled study with two arms to evaluate     JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening     period, approximately 45 subjects will be randomly assigned into one of the following two     arms in a 2:1 ratio (2 JointStem : 1 positive control). After the last subject completes     6-month visit (Visit 6) and the data management team confirms all data have no issue, the     database will be locked and the blinding will be open for the statistical analysis. Subjects     will then be scheduled for 9-month and 12-month follow-up visits (Visits 7 and 8).   "
46698|NCT02674386|"     A4091064 is a multicenter, long-term observational study of subjects from tanezumab     interventional studies (regardless of treatment group) who undergo a total knee, hip or     shoulder replacement during participation in the study. The study is designed with a total     duration of subject follow-up of 24 weeks after the total joint replacement surgery. There     will be two methods of data collection utilized in this study: interview by site staff via     the telephone and interactive web-response system (or paper if the subject has no access to     the internet).   "
46699|NCT02674373|"     The evaluation of the chemotherapy efficacy for gastric cancer patients is usually evaluated     by computer tomography scans with RECIST criteria that are performed every two months during     the treatment. The management of treatment for gastric cancer needs the development of early     biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early     chemotherapy resistance. In this prospective study, we will compare the monitoring of     circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood     level of CEA and CA 19-9 tumor markers.      Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of     tumor response according to the tumor DNA circulating assessment in gastric cancer treatment,     in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be     continued uselessly, (ii) and to allow a early changing to an alternative chemotherapy     regimen.   "
46700|NCT02674360|"     Cancer patients often report that they are not included in important treatment decisions.     Numerous studies have shown that a training concerning Shared Decision Making (SDM) for     physicians can improve this situation. This does not only lead to a better quality of the     doctor-patient interaction, but may have a positive long term impact on treatment adherence,     the psychological well-being and the coping abilities of the patients. However, previous     experience regarding the implementation of SDM training programs show that it is difficult to     recruit physicians for an external SDM group training due to the extensive workload of the     physicians. In light of the available evidence on the effectiveness of SDM training and the     low motivation by oncologists for traditional SDM group training, this study aims to develop     and evaluate a brief SDM intervention. This intervention is disseminated in two different     ways which both might be attractive for oncologists. On the one hand an individual     face-to-face context-based SDM training is designed and conducted by a trainer at the     workplace of the participating oncologists. On the other hand a web-based SDM online training     is developed. Both SDM interventions are developed on the basis of an SDM manual evaluated in     previous studies.      This study therefore aims to examine the effectiveness of different disseminations strategies     (individualized face-to-face context-based SDM individual training vs. web-based SDM online     training) compared to a control group without any training. It will be analyzed which     improvements in medical SDM competence can be accomplished by the different SDM trainings.     Further the effects of the training on SDM knowledge, quality of the doctor-patient     interaction and SDM self-efficacy expectation will be evaluated.   "
46701|NCT02674347|"     Study to evaluate the safety and tolerability of multiple escalating doses of intravenous     (IV) Zidebactam in healthy adult human subjects.   "
46702|NCT02674334|"     The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on     participants undergoing shoulder surgery in the beach chair position to determine cerebral     desaturation events and to further determine cognitive changes pre and post surgery using the     Mini Mental State Exam.   "
46703|NCT02674321|"     The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of     SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the     pharmacokinetic of SD-809 and its metabolites.   "
46704|NCT02674308|"     The purpose of this study is to assess the long-term safety of vedolizumab versus other     biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).   "
46705|NCT02674295|"     The purpose of this study is to determine the metabolic disposition of radiolabeled     esketamine administered by the oral and intravenous routes in healthy male participants.   "
46708|NCT02674256|"     Introduction and aim      Stress is well known to affect visceral sensitivity in Human. The investigators speculate     that visceral hypersensitivity plays an important role in symptom perception in     gastro-esophageal reflux disease (GERD). The role of acute stress mimicked by corticotrophin     releasing hormone (CRH) administration on esophageal sensitivity has not been studied. The     investigators hypothesize that stress mediated through CRH-release increases esophageal     sensitivity. A first step in the investigation of this hypothesis is to study whether     administration of CRH has an influence on esophageal sensitivity in healthy volunteers (HV).     Therefore, the aim of this study is to investigate the effect of CRH-administration on     esophageal sensitivity in a group of HV.      Methods      The study will be performed in cross-over on 15 HV with no prior history of digestive     disease. Esophageal sensitivity will be tested by multimodal stimulation on two sessions     (placebo and CRH-administration), with an interval at least of one week. The two sessions     will be scheduled by randomization for every subject. After blinded administration of CRH     100µg or placebo IV, esophageal sensitivity will be assessed using a multimodal esophageal     stimulation probe which allows thermal, mechanical, electrical and chemical stimulations of     the esophagus. Esophageal sensitivity will be assessed using Visual Analogue Scale (VAS), the     mood with specific questionnaires (Manikin Self assessment SAM, Profile of Mood Schedule     (POMS, State Trait Anxiety Inventory (STAI)) and the cortisol with salivary samples.      Statistical analysis      Esophageal sensitivity for the different stimuli (heat, mechanical, electrical and chemical)     will be compared between CRH and placebo conditions. To determine the stress-inducing     capability of CRH-administration, the POMS questionnaire, STAI, Manikin self assessment and     cortisol levels after the stress-protocol will be compared with the basal measurements.      Perspectives      If CRH-administration increases esophageal sensitivity, a stress model could be applied to     investigate the influence of a real life stressor on esophageal sensitivity in healthy     subjects. In a third part, a mast-cell stabilizing drug could be tested after administration     of a stressor in order to investigate its role on esophageal sensitivity. In the future, this     might be proposed to refractory GERD in a controlled randomized trial.   "
46709|NCT02674243|"     This is prospective randomized control trial study. The aim of this study is to evaluate the     efficacy of Iodopovidone solution for pleurodesis in palliative malignant pleural effusion     (MPE) patients comparing to Talc. All adult patients who diagnosed MPE by cytology regardless     primary tumor between December 1, 2015 and November 29, 2016 at Maharaj Nakorn Chiang Mai     Hospital, Chiang Mai University, Chiang Mai, Thailand will be enrolled in this study. The     inform and consent will be applied in all patients before treatment. Patients will be     randomized to two groups; Iodopovidone group (intervention group) and Talc group (control     group)   "
46710|NCT02674230|"     This study aims to study the relationships between obesity, circadian rhythm, and aging. The     investigators set up a prospective cohort registry for morbid obesity, obesity, and normal     subjects with annual follow-up. The cohort aims to investigate the pathophysiological,     molecular, genetic, and cellular aspects of the relationships between obesity, circadian     deregulation, and impacts on aging. Clinical data, questionnaires, biological material, and     molecular signatures will be collected and investigated.   "
46711|NCT02674217|"     Multiple sclerosis (MS) is a chronic, inflammatory, debilitating disease that causes     destruction of central nervous system (CNS) myelin, with varying degrees of axonal damage. It     mainly affects young adults and is twice as common in women as in men (1). Studies published     from the 1990s brought animal models and theoretical considerations of hematopoietic stem     cell transplantation (HSCT) being useful in the prevention and treatment of autoimmune     diseases, with clinical responses in some patients, suggesting that high-dose chemotherapy     followed by HSCT rescue could reset the immunological changes through the control of     autoreactive clones, followed by immunological tolerance after immune reconstitution (2);     this led to the conclusion that HSCT may be a viable therapeutic option for MS (1-6).     Autologous HSCT have been done in patients with MS since 1996 and more than 700 HSCTs have     been performed around the world (1-6). Most patients have been treated in small trials or in     multicenter studies. In retrospective analyzes, a progression-free survival of more than five     years after transplant has been observed, the neurological outcomes being considerably more     favorable in patients with the relapsing-remitting type and/or those who showed an     inflammatory pattern in magnetic resonance imaging (MRI) during the pre-transplant screening.     Reports of good results, particularly in the aggressive forms of MS reinforce the     effectiveness HSCT in MS patients with prominent inflammatory activity. The risk of     transplant related mortality in HSCT for MS was conventionally considered very high but has     declined since 2001 to 1.3% (2-6), this probably being the result of the changes in the     conditioning regimens, thus reducing toxicity. Recent data, with more than 700 autologous     transplants for MS in Europe, showed an overall survival of 92% in five years and a     progression-free survival of 46%, the main cause of mortality and morbidity being the     recurrence of the autoimmune disease (2-6). The consensus provides an indication of HSCT in     patients with progressive MS unresponsive to conventional therapy and Expanded Disability     Status Scale (EDSS) (1) between 3.0 and 6.0. The forms of the disease that might benefit from     transplantation are: relapsing remitting, primary or secondary progressive, and the     malignant form, provided there is evidence of inflammatory activity at the time of     transplant indication.   "
46713|NCT02674191|"     Treating hyperdivergent malocclusion accompanied by open bite could be challenging and may be     done by several methods as high pull headgear and posterior bite planes or surgically by     maxillary impaction in adults. Nowadays it's the skeletal anchorage system (SAS) era as     mini-screws and mini-plates ,hence we are aiming for absolute anchorage, and could minimize     patient cooperation and the need for surgical treatment.   "
46714|NCT02674178|"     All women had normal uterine cavity determined by previous hysterosalpingography or     hysteroscopy. Women with abnormally low Gn as hypothalamic hypogonadism , High LH as PCOS and     women with abnormal endocrine functions as abnormal thyroid or adrenal functions were     excluded. Any woman with ovarian cyst or azopermic male partner was also excluded.      The patients were subjected to history taking, including age, duration, type and cause of     infertility and medical history. Full examination including general and abdominal and vaginal     examination was done followed by ultrasound evaluation for presence of 3 or more pre-antral     follicles and exclusion of ovarian cysts.      Basal day 3 hormonal evaluation for FSH, LH and E2 in a natural cycle was done. E2, FSH and     LH levels were determined using Immulite system (Siemens Healthcare diagnostics,UK).The     intra- and inter-assay coefficients of variation were 15% and 16% for E2, 4.8% and 26% for     LH. FSH analytical sensitivity was 0.1 mIU/ml.      All participants underwent long protocol. Daily SC injection of Triptorelin : Decapeptyl 0.1     mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle     and continued till the day of hCG injection. Gn stimulation started after fulfilling     stimulation start criteria of thin endometrium < 5 mm and low E2 < 50 and LH < 5IU/l [18]     with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a     starting dose of 150-300 IU/day depending on patients age and previous gonadotropin response.     then the dose was adjusted according to ovarian response monitored by serum E2 and ultrasound     evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on     alternate days according to the ovarian response to treatment starting on treatment cycle day     (6) for folliculometry and endometrial thickness and pattern.      Triggering by HCG 10000 IU IM (Pregnyl, Organon, the Netherlands) when at least 2 follicles     reached a mean diameter of 18 mm [18]      Cycle cancellation was decided when transvaginal ultrasound scan on cycle day (9) revealed no     adequate follicular growth (<3 mature follicles).      Ovum pick-up (OPU) was done 34-36 hours after hCG injection under transvaginal ultrasound     guide.   "
46730|NCT02673970|"     1. Screen and recruitment: patients will be screened based on their prior history and          intention to initiate treatment with an immune checkpoint inhibitor.        2. Study phase:             -  Collection of baseline demographic data, prior disease history, nature of ICI               therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor               response and survival).             -  Collection of blood samples will be performed every 3 to 4 weeks for the first year               on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy,               disease progression, death or loss to follow-up. Collection of blood samples will               be aligned with the visits necessary for the administration of the ICI therapy.             -  Collection of archival melanoma metastasis tissues will be performed on a               continuous basis and be triggered by availability of such tissue following               therapeutic resections of melanoma metastases.        3. Follow-up phase   "
46715|NCT02674165|"     The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of     the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that     consists of eight sessions lasting approximately two hours each over a twelve- week period.     The comparison group will receive a nutrition intervention during the same time period. The     primary goals of the evaluation are to determine the effectiveness of the HART program on     delaying initiation of sexual intercourse, reducing number of sexual partners, and increasing     abstinent behavior and contraception use among those who were sexually experienced at     baseline.      Over a five semester period, the programs will be implemented in 7 or more schools in the     greater Boston area, with offerings in the fall, the spring and summer, among approximately     780 male and female Haitian students. The programs will recruit 9th & 10th grade Haitian     students who will range in age from 13 to 19 years old. We will implement a randomized     controlled trial in which each semester, students within schools will be stratified by gender     and then randomly assigned to participate in the HART or the nutrition condition. Students     will be recruited annually and enrolled until the summer of 2015. During the spring and     summer of 2012, 120 youth will be randomly assigned to a treatment condition. During year     three, 180 youth will be randomly assigned to condition each semester (360 youth total during     Year 3). During year four, 180 youth will be randomly assigned in the first semester, and 120     youth will be randomly assigned in the second semester (300 youth total during Year 4). The     number of times student-level randomization will occur and the number of groups formed will     vary depending on the size of the 9th and 10th grade Haitian population served in each     school.   "
46716|NCT02674152|"     This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI     836880 administered intravenously. The eligible patient population will be patients with     advanced solid tumours. At any time during the trial, it will not be permitted to escalate to     a dose which does not fulfil the escalation with overdose control (EWOC) criterion   "
46717|NCT02674139|"     The study aims to compare immediate post-placental (within 10 minutes of placenta delivery)     intrauterine contraceptive device (Copper T 380A) insertion versus conventional placement at     6 weeks (often referred to as delayed or interval insertion) regarding the clinical outcomes     (safety, efficacy, expulsion and continuation rates) for women undergoing caesarean section.   "
46718|NCT02674126|"     A newborn's recognition and preference for their mother's voice occurs early in life, very     likely during fetal development. Maternal voice stimuli undergo a unique form of cerebral     processing that lends support for the existence of neurophysiologic mechanisms that reflect a     child's preference for his/her mother's voice. This study aims to evaluate and compare the     effect t of maternal sound listening in children undergoing cardiac surgery on stress     response and physiological parameters.   "
46719|NCT02674113|"     The purpose of this research is to determine differences in outcomes in patients who receive     regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip     arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.   "
46721|NCT02674087|"     The purpose of this survey is to collect data from intrauterine life until the age of 18 of     children born in Haute Vienne.      The interest to realize such survey is to find correlations and interactions that may exist     between the events that occurred during intrauterine life and those that will occur after the     birth of the child. The investigators will examine every aspect of these children's lives     from the perspectives of health, social sciences and environmental health      These are medical events (occurrence of disease, medication), but also socio-cultural for     this child (living environment, exposure to possible contaminants, events in family history).      This cohort aims to include 3000 children a year (whose parents consented to their     inclusion), all born at Haute-Vienne.   "
46722|NCT02674074|"     Measurement of corneal temperature gives indirect information about the ocular blood flow.     For this reason corneal temperature can be used as a surrogate to quantify ocular blood flow.     It can be measured by means of infrared thermography. This test, however, is not used in an     everyday clinical routine so far. In this study is investigated if ocular blood flow     disturbances in glaucoma patients can be diagnosed by means of infrared thermography.      Corneal temperature are measured in normal tension glaucoma patients and healthy controls     before and after cold provocation test. In the group of patients and the group of controls,     subjects with and without a primary vascular dysregulation (PVD) are included. This will     allow to analyze and compare the influence of cold provocation on corneal temperature (and     indirectly ocular blood flow) in these study Groups.   "
46723|NCT02674061|"     This study will assess the efficacy and safety of pembrolizumab (MK-3475) in women with     advanced ovarian cancer who have demonstrated recurrent disease following the front line     platinum-based treatment and debulking surgery and received up to 5 lines of treatment for     recurrent ovarian cancer (ROC) per local standard of care. Participants will receive     pembrolizumab every 3 weeks (Q3W) for up to 2 years.   "
46724|NCT02674048|"     Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to     evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate     actinic keratosis of the face/scalp and to assess physician and patient satisfaction.   "
46725|NCT02674035|"     Thirty women with similar abdominal deformities, who had had at least one pregnancy, were     randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus     sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a     single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a     continuous barbed suture (group II). Operative time was recorded. All patients underwent     ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor     for diastasis recurrence. The force required to bring the anterior rectus sheath to the     midline was measured at the supraumbilical and infraumbilical levels.   "
46726|NCT02674022|"     The purpose of this research study is to screen for metabolic abnormalities that are maternal     risk factors for having a child with autism.   "
46727|NCT02674009|"     The primary purpose for this study is to evaluate the duration of response defined as     duration from first documented response of complete response (CR) or partial response (PR)     until disease progression (as determined by the treating physician) for laBCC patients.   "
46731|NCT02673957|"     This study aims to analyze the way the human body responds to a temporary lack of oxygen, or     ischaemia. Prospective participants will complete a health screen to confirm overall health /     low cardiovascular risk profile.The participants will be required to have pneumatic blood     pressure cuff inflation to 200mmHg on the upper arm for 5 minutes which will then be deflated     for 5 minutes and then repeating the cycle of inflation and deflation a further 3 times.     Blood tests from veins in the forearm would be taken before, during, and after this is done     in order to compare results and establish any change in concentration of local and     circulating compounds.   "
46732|NCT02673944|"     A comparative study will be conducted and the patient will undergo a conventional urodynamic     study. In order to successfully determine if the Peritron+ is capturing vesical pressure     measurements consistent with conventional urodynamics the two sources of Pves will be     collected concurrently.   "
46733|NCT02673931|"     Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain     and kidneys.      This study is designed as a 2-by-2 randomized clinical trial with the purpose of     investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist     Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from     cardio-pulmonary bypass.   "
46746|NCT02673762|"     A PRoBE design study will be used to obtain saliva from patients before undergoing blood     study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes     of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with     multi-marker models for their discriminatory value for distinguishing patients with normal     glucose metabolism from those with disease. Appropriate housekeeping genes will also be     incorporated to allow for the measurement of relative gene expression.   "
46734|NCT02673918|"     The investigators have developed an online rehabilitation platform to guide women in their     home-based upper-body exercises after breast cancer surgery. The platform includes     rehabilitation videos that will guide the women in performing home-based early post-surgery     upper-body rehabilitation tailored for each individual.      The primary objective is to assess the feasibility and acceptability of a home-based     rehabilitation program supported by a supplemental online platform for women after breast     cancer surgery before conducting a larger pragmatic trial in the future. The feasibility of     the platform will be tested in 11 municipalities in Denmark.   "
46735|NCT02673905|"     The purpose of this study is to investigate the efficacy of an engineered cartilage     transplant (N-TEC) in comparison to a cell-activated matrix (N-CAM) for the treatment of     articular cartilage lesions in the knee. The main innovations in this trial are the use of     nasal chondrocytes and the implantation of a tissue in contrast to cells seeded on a matrix.     The goals of the trial are to: (i) evaluate whether implantation of a more mature graft     (tissue therapy) is beneficial for the quality and durability of the repair tissue and the     clinical outcome, (ii)determine the potential of the mature graft to integrate with the     adjacent cartilage and form hyaline repair tissue and (iii) assess the efficacy of each     treatment in correlation to the characteristics of the defect (e.g. acute versus chronic     setting).   "
46736|NCT02673892|"     Improving the patient experience has become a major focus of quality improvement efforts in     Ontario and in health systems worldwide. However, our existing knowledge base is relatively     under-developed, particularly in how patients experience care as they transition from one     care setting to another and the relationship between patient experience and clinical     outcomes. The Patient Oriented Discharge Summary (PODS) is a discharge instruction tool     created by patients, caregivers, health-care providers and design experts. It provides a     written template for providers to engage patients and caregivers when reviewing important     instructions on medications, activity and diet restrictions, follow-up appointments and     worrisome symptoms warranting emergency care following admission to hospital. The PODS also     uses plain and simple wording, large fonts, pictograms, and includes white space for patients     to take notes and provides the option for translation of major headings into the most common     spoken languages. The PODS impact study will study the impact of using the PODS versus usual     discharge instructions on patient experience and health outcomes in a provincial-wide     randomized study across acute care and rehabilitation hospitals.   "
46737|NCT02673879|"     The Second Investigation of the Management of Pericarditis (IMPI-2) Trial will compare the     effectiveness and safety of complete percutaneous pericardial drainage facilitated by     intrapericardial alteplase (recombinant human tissue-type plasminogen activator) to     conventional pericardiocentesis when indicated in 2176 patients with large pericardial     effusion due to tuberculous and non-tuberculous pericarditis. An internal pilot study of 218     patients will initially confirm the feasibility of conducting a large-scale multi-centre     clinical trial of intrapericardial fibrinolysis in patients with large pericardial effusion,     and also provide preliminary safety data, following a dose finding study of intrapericardial     alteplase.   "
46738|NCT02673866|"     The hypothesis of this Phase 2 study is that at least 1 dose regimen of DS-1971a will     demonstrate clinical superiority to placebo in managing pain associated with DPNP, and will     be generally well tolerated.   "
46739|NCT02673853|"     This study aims to establish the incidence of residual paralysis in patients following     administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in     most patients) during supraglottic airway insertion and correlate it with the duration of     time from drug administration to arrival at PACU. The secondary aim is to compare the     incidence of residual paralysis in patients who receive full doses of atracurium (per body     weight) with those who receive mini-doses.   "
46757|NCT02673619|"     Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is     anticipated that topical administration of UMEC will block stimulation of muscarinic     receptors, thereby reducing the overproduction of sweat in subjects who suffer from     hyperhidrosis. This study will assess the clinical effect, pharmacokinetics, safety and     tolerability of topically applied UMEC following once daily topical administration, for 28     days, to the palms, in subjects with primary palmar hyperhidrosis. The study will also     investigate if topically applied UMEC, at the highest possible concentration, will decrease     palmar hyperhidrosis with a systemic anticholinergic adverse event profile similar to or     below that observed with inhaled administration. This is a double blind (Sponsor unblind),     repeat dose, randomized, parallel group, placebo controlled study. Study will enrol up to 55     subjects.   "
46740|NCT02673840|"     Rationale and Aims: Infection by dengue virus (DENV) causes major morbidity and mortality     throughout the world. In 2012, an estimated 3.6 billion people live in areas at risk for DENV     infection, including Singapore. The key pathology of DENV infection is vascular leakage,     which can occur in mild cases and can become life-threatening in severe cases when patients     may develop dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS). Mast cells (MCs)     are strongly activated by DENV with preliminary studies showing that activation levels are     correlated to disease severity in human patients. Thus, the investigators propose to use the     MC stabilizing drug, ketotifen, to limit the immune pathology that is characteristic of     dengue infection and treat dengue-induced vascular leakage. Methods: The ability of Ketotifen     to reduce vascular leakage in DENV patients will be determined by assessing the pooling of     fluid in the pleural cavity (measured by MRI and CXR) after 5 days of drug administration,     evaluated as a percent change compared to baseline fluid levels. Additional measures of     vascular leakage and immune pathology will be compared as secondary objectives. The trial     will be conducted as a randomized, double-blind study comparing the responses of dengue     patients given either ketotifen or placebo (n=55 per arm). Importance of proposed research:     Currently, no targeted treatments exist to limit vascular leakage during DENV infection. If     Ketotifen is identified as effective for preventing pleural effusion and/or plasma leakage in     DENV patients, this would constitute an advance for the clinical management of DENV fever.     This finding would also support a large-scale trial to determine whether Ketotifen can be     used to prevent severe vascular leakage as occurs during DHF/DSS. Benefits/Risks: Ketotifen     has a record of safety and tolerability in humans, regulatory approval, and widespread use.     Side effects are generally mild. The potential exists that, if effective, many of the painful     and life-threatening symptoms of DENV infection that result from plasma leakage would be     improved.   "
46741|NCT02673827|"     Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on     stress and depression levels of individuals with multiple sclerosis.   "
46742|NCT02673814|"     The primary purpose of this research study is to see whether adding bavituximab (an     investigational drug) to durvalumab will improve the results of the treatment for     non-small-cell lung cancer.   "
46743|NCT02673801|"     The purpose of the study is to evaluate an algorithm to screen patients with suspected knee     osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and     patient-reported symptoms. It will be investigated whether the algorithm is able to identify     which patients that are deemed relevant to undergo an orthopedic assessment. This will be     evaluated by estimating the sensitivity of the new algorithm compared to with the traditional     clinical assessment of the patients.   "
46744|NCT02673788|"     This is a follow-up study of the open label, single-center, phase I clinical trial to     evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.   "
46745|NCT02673775|"     The purpose of the study is to better understand the mechanisms of lung injury from ozone     exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone.     Subjects will be asked to produce sputum through coughing after each exposure. The samples     will be analyzed for macrophage activity.   "
46749|NCT02673723|"     Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to     find a safe and effective method for intubation. Awake tracheal intubation which is used to     retain spontaneous breathing is one of the important measures to ensure the safety of the     patients with difficult airway in anesthesia.      Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of     awake tracheal intubation, however, the outstanding problem is serious respiratory depression     after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid     antagonist related to mild respiratory depression and can prevents sufentanil-induced cough     during general anesthesia induction.It is necessary to carry out large-scale, multi-center,     randomized, controlled clinical study to determine whether dezocine prevents     sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe     and effective method for awake tracheal intubation.   "
46750|NCT02673710|"     The purpose of this study is to explore the relationship between sarcopenia, as defined by     computed tomography, treatment related outcomes and other body composition related parameters     in a patient population receiving bevacizumab beyond progression.   "
46751|NCT02673697|"     Prospective, randomized, stratified non blinded multi-center, international, post market     trial assessed in a non-inferiority study.      A minimum of 1234 subjects will be enrolled at approximately 60 worldwide investigational     sites where the device is commercially available.      The primary objective of this trial is to test the safety and efficacy of Perceval versus     standard sutured stented bioprosthetic aortic valves among the intended trial population.   "
46752|NCT02673684|"     The purpose of this study is to evaluate the ability of Neuro-Stim System, a     non-pharmacologic alternative for pain management, to reduce pain and treat insomnia.     Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the     ear and possibly the autonomic nervous system.   "
46753|NCT02673671|"     A feasibility study for assessing and recording myoelectric activity in patients for early     detection of a post-operative ileus (POI) in patients who undergo gastrointestinal surgery     and differentiating the myoelectric signals from those who have normal post-operative return     of GI function.   "
46754|NCT02673658|"     The purpose of this longitudinal study is to examine the ongoing interaction between the     domains of cognitive and motor development in infants with neuromotor disability, and to     compare outcomes of two groups of infants receiving two different types of home-based,     parent-delivered physical therapy intervention, in order to determine which intervention is     more effective in advancing cognitive as well as motor development. Knowledge of the     effectiveness of two types of intervention will lead to improved early intervention for     children with developmental disabilities, as well as future studies to examine ongoing     outcomes.   "
46755|NCT02673645|"     This research aims to continue to study the effectiveness of a promising academic     intervention (implemented by SAGA Innovations) that has previously been shown to     significantly improve academic outcomes for disadvantaged youth. In addition, this study will     begin to investigate the effects of scaling up this promising strategy by exploring variation     in tutor effectiveness and the optimal instructor-student and student-student pairings for     improving academic outcomes.   "
46756|NCT02673632|"     The investigator suggests that PCOS women with high AMH levels are resistant to ovarian     stimulation and may need adjustment of the dose of gonadotrophin.   "
46758|NCT02673606|"     The goal of this project is to examine how estrogen may influence the resting-state     connectivity and the extinction-induced activation of the fear extinction network.   "
48162|NCT02655211|"     This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2)     laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and     will determine the optimal sequence and timing of lasers and usual care.   "
46759|NCT02673593|"     The purpose of the study is to investigate the safety, pharmacokinetics and food effect of     DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.      DS102 capsules will be orally administered for up to 4 weeks, and will be compared against     placebo.      The study will enrol approximately 56 adult subjects.   "
46760|NCT02673580|"     The aim of this study is to compare quality of care and patient experiences in two     outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and     2) Open Access telePRO (patient-initiated telePRO follow-up)   "
46761|NCT02673567|"     This is a single center, randomized, double-blind, placebo-controlled study to assess the     pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125     (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy     subjects.   "
46762|NCT02673554|"     In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic     polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus     bolus administration. The design was a two-way crossover design comparing repeated bolus     injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients were     age- gender- and weight-matched with type 2 diabetes, first degree relatives of such     patients, and healthy subjects. Investigators performed a:        1. Oral glucose challenge;        2. hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50 pmol/kg          body weight at 30 and 120 min); and        3. hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180          min).      To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic     action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives,     and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90     min apart, and compared this to a continued intravenous infusion of GIP.   "
46764|NCT02673528|"     Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall     incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical     removal of the inflamed appendix by using open or laparoscopic appendectomy.      Following laparoscopic appendectomy (LA) proved to be a feasible and at least as safe as the     corresponding open procedure, it has rapidly gained worldwide acceptance. The traditional     approach to LA uses three ports. Over the past decade, successful attempts to perform the     procedure with fewer ports have been reported.      The authors' primary objectives were to 1) identify a simple, safe and feasible way to     perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2)     determine the health related quality of life of the patients and calculate the cost per     quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a     surgical algorithm when approaching to acute appendicitis with the consideration of quality     of health and cost.   "
46765|NCT02673515|"     InterFast is a Cohort study with an embedded randomized controlled pilot trial. Study     participants will be healthy subjects and subjects who already practice Alternate Day     Fasting. The trial will include 100 participants (50 Participants in Alternate Day Fasting     group and 50 participants in the control group). Those participants in the control group will     be asked to participate in a short randomized controlled trial, where they will be either     allocated to an Alternative Day Fasting group or another control visit.   "
46767|NCT02673489|"     The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with     Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients     with liver cirrhosis.   "
46768|NCT02673476|"     This study is being to see how effective and safe ALS-008176 is in treating adults in the     hospital with a Respiratory Syncytial Virus-Related Illness.   "
46769|NCT02673463|"     This study aims to assess whether treatment with a drug called spironolactone, which is an     aldosterone inhibitor, can improve ability to cope with exertion, quality of life and ability     of the heart to relax better in symptomatic patients with atrial fibrillation with preserved     pumping capacity.   "
46770|NCT02673450|"     This study investigates a possible relationship between disturbance of the cyclic expression     of ten different clock genes and development of delirium in patients admitted to an intensive     care unit      It also investigates a possible relationship between disturbance of the cyclic expression of     melatonin and development of delirium in patients admitted to an intensive care unit.      Finally a possible relationship between genetic differences in the PER3 gene and development     of delirium is investigated.   "
46771|NCT02673437|"     Rivaroxaban is a medicine which reduces the formation of blood clots. Acute coronary syndrome     (ACS) comprises a range of disorders, including heart attack and unstable angina, caused by a     sudden reduction in blood flow to part of the heart muscle. This study aims to collect     information on the use of rivaroxaban and its safety when used by patients for the prevention     of atherothrombotic (plaque rupture leading to a blood clot) events following ACS, during the     first three months after starting. This study was requested by the European regulatory body     (EMA) which is responsible for the use and safety of medicines. It will last for     approximately 3 years and is a national study covering the whole of England and Wales. The     study aims to recruit 1193 patients who have been prescribed rivaroxaban and antiplatelet     therapy and 1193 patients who have been prescribed alternative dual antiplatelet therapy for     the secondary prevention of atherothrombotic events following ACS. Each patient will only be     monitored for the first 13 weeks after hospital admission for ACS. Patients who choose to     take part will complete a consent form. The patient's care team will be asked to complete a     baseline questionnaire about the patient at the time the medicine is given and a further     questionnaire up to 16 weeks later, specifically asking about the patient's experiences     whilst on the medication. If anything unusual is reported during the observation period, the     care team may be asked to fill out a followup questionnaire. With the patient's consent, the     study team will also inform the patient's General Practitioner (GP) of their participation in     the study and will ask the GP to complete an abridged questionnaire from the patient's     medical records. The study team will analyse and aggregate the data, carefully protecting     patient confidentiality, to classify adverse events of interest, in particular bleeding     events.   "
46772|NCT02673424|"     To compare the safety and efficacy of FFR (fractional flow reserve)-guided percutaneous     coronary intervention (PCI) strategy with IVUS (intravascular ultrasound [IVUS])-guided PCI     in patients with intermediate coronary stenosis.   "
46773|NCT02673411|"     The purpose of this study is to measure diagnostic performance of ultrasound shear wave     elastography to detect advanced hepatic fibrosis.   "
46774|NCT02673398|"     This phase II trial studies the side effects of and how well neratinib works in treating     older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer     that has spread from where it started to other places in the body (metastatic). Neratinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
46775|NCT02673385|"     In France, the last national perinatal survey show that 6.6% of live births are premature.     For these infants, transfer in Neonatology sector may result in mother-child separation can     last several weeks or months. This hospital can complicate the implementation of the     attachment process that allows parents to recognize their children as their own, to gain     confidence in their abilities to deal with them and establish a relationship with him.      A study of mothers of premature shows the interest of the Brazelton scale to help them     identify the skills their child and adjust their own behavior.   "
46797|NCT02673086|"     The primary aim of this study is to compare needle tip visibility between the coracoid     approach and retroclavicular approach for infraclavicular brachial plexus block in patients     undergoing elective upper limb surgery. Secondary aim is to investigate the differences     between the two groups in the needle shaft visibility, sensorial block success rate, block     performance time, block performance related pain, motor block success rate, surgical success     rate, complications, patient satisfaction, use of supplemental local anesthetic, use of     analgesic.   "
47002|NCT02670395|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of     JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of     JNJ-54416076 when co administered with food compared to administration in fasting condition     (in Part 2).   "
46776|NCT02673372|"     This research project is geared towards geriatric analgesia in the Emergency Department (ED)     with a goal of reducing the administration of opioid pain medications to elderly patients,     thereby avoiding the commonly occurring, severe side effects associated with such     medications, including hypotension, respiratory depression, altered mental status, delirium,     as well as nausea/vomiting and constipation.      The primary outcome of the study will be difference in pain score from baseline to 30 minutes     post-medication administration. The secondary outcomes will be the need for rescue analgesia     and the incidence of adverse side effects and patients' satisfaction with low-dose ketamine     or low dose morphine analgesia in managing their painful conditions in the ED.      This project has the potential to change and modify the ED approach to geriatric analgesia by     virtue of minimizing the use of opioid administration in elderly patients. T   "
46777|NCT02673359|"     The aim of this study to compare vaginal progesterone supplementation to cervical cerclage     for prevention of preterm labor in women with short cervical length and history of previous     midtrimester miscarriage and/or preterm labor.   "
46778|NCT02673346|"     The aims of this study are 1) To assess the prevalence of tobacco use and cessation treatment     preferences among YKHC employees, 2) To assess employee's current levels of perceived stress,     engagement in physical activity, and feelings of resiliency to inform future tobacco     cessation interventions, and to examine the relationship between these factors and tobacco     use, and 3) To assess YKHC employees' perceptions and opinions of the hospital's current     workplace tobacco policy and expansion of these regulations to all YKHC properties.   "
46780|NCT02673320|"     The studied pathology concerns post traumatic cervical spinal cord contusion on narrow spinal     canal.      The pathophysiology remains controversial. This pathology does not enjoy consensus support.     Many questions remain regarding the surgical care and its delay.      The purpose of the study was to demonstrate non-inferiority of early surgical treatment     compared to the same surgery performed with a delay among patients identified as having a     cervical spinal cord contusion on posttraumatic narrowed cervical canal.      In the current state of knowledge and practices, the treatment of post traumatic spinal cord     contusions on narrow spinal canal spinal decompression is performed remote diagnosis. The     generally accepted delay is 15 days.      The surgical technique is a conventional cervical spinal decompression surgery. The type of     decompression (anterior or posterior) is dependent on the compression and therefore the     clinical radiological analysis. The choice of the technique and the surgical approach are     therefore left to the discretion of the surgeon.      After completion of the clinical and radiological diagnosis of post-traumatic spinal cord     contusion on narrow spinal canal, the patient was hospitalized in intensive care or in the     Neurosurgery Service of the University Hospital concerned.      After anesthetic consultation determining the feasibility or not of surgery and in the     absence of other vital injury or involving life-threatening, early surgery within 48 hours of     diagnosis is then considered (according to the assigned group).      The surgical technique is a conventional cervical spinal decompression surgery. Way posterior     surgery, laminectomy for spinal stenosis significant if greater than or equal to 3 floors     will be preferred. In other cases, the type of surgery will be at the discretion of the     surgeon and the opinion of the Staff Neurosurgery.      The surgical procedure is identical in the two groups. Alone, the delay of the surgery varies     : less than 48 hours for the first group and 15 days for the second.      During the different monitoring visits (D0 (surgery), D7, M3, Y1 and Y2), the following     criteria will be assessed : the quality and quickness of the motor and sensory recovery, the     early post-operative evolution and the long and medium term evolution but also disability and     functional sequelaes.   "
46781|NCT02673307|"     The aims of this prospective cross over study was to compare the gastric emptying of 250 ml     water in fasting volunteers, in two situations : without chewing gum or while chewing gum     during 45 min   "
46782|NCT02673294|"     The level of stroke chronicity has been proposed as an influential variable related to     functional balance. However, little is known about the effect of this variable on the     effectiveness and maintenance of gains of physical therapy interventions on balance. The     objective of this study is to determine the influence of time since injury on the     rehabilitation of balance after stroke. Participants will be assigned to a least (6-12     months), a moderate (12-24 months), or a most chronic (> 24 months) group. All the     participants will train for 20 one-hour sessions, administered three to five times a week,     combining conventional physical therapy exercises and customized exercises interfaced on a     balance board that promotes the training of the ankle and hip strategies. Participants will     be assessed before, after the intervention, and one month later with a posturography test     (sway speed and limits of stability) and clinical scales (Berg Balance Scale, Functional     Reaches Test, 30-Second Sit-to-Stand Test, Timed Up and Down Stairs Test, Stepping Test,     Timed Up-and-Go Test, and the 10-meter Walking Test).   "
46783|NCT02673281|"     The purposes of the study are:        -  Study Aim 1. To assess the mechanisms underlying the biological effects of short-term          walnut consumption on appetite with functional magnetic resonance imaging (fMRI) and          assessing neurocognitive function/memory        -  Study Aim 2. To investigate the effects of walnut consumption (48g per day over 5 days)          on appetite and satiety by analyzing molecules which regulate energy homeostasis such as          adipokines, as well as resting metabolic rate which measures energy expenditure.        -  Study Aim 3. To investigate the effects of walnuts (48g per day over 5 days) on insulin          resistance, lipids, and inflammatory markers in obesity as well as the effect of walnuts          when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the          excretion of gut peptides and free fatty acids.   "
47049|NCT02669784|"     Any adult patient age18 and above, scheduled for routine CTA of the chest or chest, abdomen     and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included     in the study. The patient will be administered a low dose of intravenous contrast based on     the study examination.   "
46784|NCT02673268|"     The objective of this study is to demonstrate the feasibility of a mastectomy with     conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate     breast reconstruction using prosthesis.      The interest is to avoid scars on the breast. The scars are limited to the armpit and under     the arm.      The aim is also to study the rate of complications, cosmetic results and quality of life.   "
46796|NCT02673099|"     Introduction: Patients with end stage renal disease are exposed to metabolic and hemodynamic     complications due to the disease itself and as a result of the dialysis treatment related     complications. Uremic toxins due to their middle molecular weight are not effectively removed     during Hemodialysis. Their accumulation leads to chronic oxidative stress and chronic     inflammation state associated with increased morbidity and mortality. In addition, during     each dialysis session oxidative stress (OS) and inflammation are provoked once blood     interacts with the dialyzer.      In recent years the use of Online Hemodiafiltration (OL- HDF) has entered in order to enable     better uremic toxins clearance. This a relatively new method of therapy that allows a larger     volume of blood filtration during a single dialysis therapy compared with standard     hemodialysis. It combines diffusion with convection to clear middle molecular weight     substances more effectively compared with Hemodialysis. This method was found to reduce rates     of cardiovascular morbidity and mortality among dialysis patients.   "
46785|NCT02673255|"     Many plasma donation centers have Tetanus immunization programs that are implemented in order     to collect plasma with high levels of tetanus antibodies. The immunization program requires     participants to receive multiple tetanus vaccinations over a period of time with the goal of     hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a     tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus     disease.      The Tetanus vaccine previously used for these programs is no longer being manufactured.     Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this     purpose. The only other FDA approved Tetanus vaccines currently available for adults in the     US are combination vaccines that also immunize against Diphtheria and/or Pertussis.      In this study, the investigators will evaluate two vaccines that are combinations of Tetanus     and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis     antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur     (Tenivac).      The package insert for these vaccines indicates they should be administered to previously     vaccinated people once every 10 years. However, this study will evaluate whether they are     safe and effective for dosing every 90 days.      The investigators hypothesize that at least 25% of study subjects will have a positive     response to at least one of the five planned doses. Each vaccine will be evaluated     separately.   "
46786|NCT02673242|"     This study is a randomized controlled trial with the aim of evaluating the effect of     homebased inspiratory muscle training (IMT) for patients with COPD in Norway. The     intervention group will train with threshold IMT for 6 weeks. The control group will not     participate in any other training method or sham. Evaluation parameters are maximal     inspiratory pressure, six minute walk test, COPD assessment test, modified Medical research     council dyspnea scale and spirometry.   "
46787|NCT02673229|"     By doing this study, researchers hope to learn if applying Santyl to the burn during the     healing process affects the appearance of the resulting scar.   "
46788|NCT02673216|"     Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse     out-come of pregnancy and a significant proportion is caused by infection. The investigators     aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of     gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously.     Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV)     subclasses, to vaginal fluid inflammation markers, and to the presence of novel     Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative     PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on     selected specimens with the aim to identify markers allowing for a personalised treatment     approach.   "
46789|NCT02673203|"     To investigate whether the daily glucose profiles as assessed by continuous glucose     monitoring for 1 week of normal weight, obese, and diabetic individuals relate to hunger     levels and food intake.   "
46790|NCT02673177|"     This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total     mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter-     preservation outcomes for low rectal cancer.   "
46791|NCT02673164|"     The aim of the SCIENCE study is, in an international multicentre double-blind     placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100     mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in     patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.   "
46792|NCT02673151|"     This trial studies how well gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC     (68Ga-PSMA) positron emission tomography (PET)/computed tomography (CT) works in detecting     prostate cancer that may have come back in patients with elevated prostate-specific antigen     (PSA) after initial treatment. A rise in blood level of PSA, a protein made by the prostate,     after treatment with surgery or radiation in patients without symptoms indicates that the     cancer may have come back (recurrence). PSA however cannot determine whether the disease is     located only in the prostate or other places in the body. 68Ga-PSMA is a radioactive tracer     that targets and specifically binds to tumor cells expressing PSA making them lighting up.     PET and CT make computerizing pictures of areas inside the body where the radioactive     substance is lighting up. 68Ga-PSMA PET/CT may be able to see smaller tumors than standard     imaging and may help determine whether prostate cancer has come back and where it is in the     body.   "
46793|NCT02673138|"     This study will be an open-label, cross-over study as subjects will be studied under both     study conditions - suspension of subcutaneous insulin infusion via pump during treatment with     insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with     insulin and canagliflozin.   "
47050|NCT02669771|"     The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in     patients.   "
47051|NCT02669758|"     The primary objective of this study is to evaluate the long term safety and tolerability of     ALKS 3831 in subjects with schizophrenia.   "
46794|NCT02673125|"     Chromosomal abnormalities are a major cause of pregnancy loss. Preimplantation Genetic     Screening (PGS) using Next Generation Sequencing (NGS) allows the effective detection of     these abnormalities and improves clinical outcomes. However even the transfer of a     chromosomally normal embryo does not guarantee successful implantation. Recent research by     Fragouli, et. al. 2015 has demonstrated a strong association between mitochondrial DNA     quantities (also known as MitoGradeTM) and implantation outcomes in embryos that are already     classified by PGS as chromosomally normal. Investigators have also demonstrated in a clinical     study that MitoGradeTM normal and PGS normal embryos have higher chances of implantation than     MitoGrade elevated PGS normal embryos. Transferring MitoGrade elevated PGS normal embryos     results in less than 10% implantation rates while MitoGrade normal PGS normal embryos     resulted in more than 65% implantation rates. The risk of miscarriage after replacing either     type is very low (about 8%).      In order to understand the complete effectiveness of the test, investigators are conducting a     paired prospective study. This means that investigators will be transferring a MitoGrade     normal and a MitoGrade elevated embryo at the same time to see if one implants better than     the other. It is expected that patients joining this study will benefit from knowing that at     least one embryo is MitoGrade normal PGS normal.   "
46795|NCT02673112|"     To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile     health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth     with persistent concussion symptoms.   "
47003|NCT02670382|"     The objective of this study is to provide critical information regarding both common and     distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.   "
46798|NCT02673073|"     Before a HF patient gets maximally decompensated and visit emergency department, most     patients experience symptoms and signs of on-going decompensation (or pre-decompensation),     which may not be noticed by the patients. If HF patients were aware of symptoms and signs of     ADHF and received early intervention to stop the process of on-going decompensation (or     pre-decompensation), it would be possible to reduce the rate of hospitalization for ADHF or     death. Thus, self-awareness and self-examination of heart failure symptoms, signs and medical     compliance using a patient diary in HF management may improve the outcomes in chronic stable     HF patients. A patient diary with 6 parameters can serve this purpose: body weight, blood     pressure, heart rate, drug compliance expressed as number of remaining pills of previous day,     edema grade, and dyspnea grade.   "
46799|NCT02673060|"     This study evaluates MBC-11 (a conjugate of a bone-targeting vehicle (etidronate) and a     cytostatic agent [ara-C] in patients with malignant tumors with CIBD. This is a first use in     human.   "
46800|NCT02673047|"     This study will describe the prescription conditions of botulinum toxin Type A (Botox®)     injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity     (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in     France.   "
46801|NCT02673034|"     The aim of the study is to investigate the circadian variation in serum-progesterone in women     undergoing controlled ovarian stimulation.   "
46802|NCT02673021|"     Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?   "
46803|NCT02673008|"     Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute     leukemia, but relapse remains an important problem. Therapy options for relapse include     stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI),     and another transplantation used alone or in combination. However, the efficacy of these     interventions is limited. One approach to the relapse problem is to intervene before     hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this     study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in     patients with acute leukemia receiving allo-HSCT.   "
46804|NCT02672995|"     The investigators propose a new treatment strategy of fractionated stereotactic radiosurgery     with concurrent bevacizumab for brain metastases. This phase I dose-escalation study is to     establish the feasibility of this strategy and find the recommended doses.   "
46805|NCT02672982|"     The overall objective of the research is to assess the long-term and cost-effectiveness of a     combined nutrition psychosocial intervention to a stand-alone nutritional treatment of     children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of     Nepal.   "
46806|NCT02672969|"     This study aims to evaluate the pre-post smoke evacuation uses on surgical smoke and     bio-aerosols particles in operating rooms at a university hospital, Thailand.   "
46807|NCT02672956|"     Investigators selected participants who operated by laparoscopic technique due to any     gynecologic indication according to random number table. The ten mm trocar was inserted     supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of     patients. One month after we evaluated umbilical scar by used vancouver scar scale and     compared results of vancouver scar scale.   "
46808|NCT02672943|"     In this three-year project, our research teams are going to consecutively explore these     important clinical, drug and physical rehabilitation treatment effects, noradrenergic     network, autonomic dysfunction and microRNA signalling data as well as the correlations     between them in early Parkinson Disease (PD) patients. The investigators hypothesize that the     explorations of the above insights are unique and can provide an important source data for     Taiwanese Parkinson Disease (PD).   "
46809|NCT02672930|"     Hyperkalemia is a common problem in the emergency services and one of the life threatening     metabolic emergencies. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics,     sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially,     avoiding evolution of serious arrythmias and iv calcium using in the treatment of occured     electrocardiogram (ECG) abnormalities, there is not sufficient level of survey in the     literature. So the aim of this study was to evaluate administration of iv calcium efficiency     on vital signs and ECG.   "
46810|NCT02672917|"     Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9     Positive Malignancies.   "
46811|NCT02672904|"     comparison results of treatment of early stage glottic cancer between two methods of surgical     treatment - CO2 laser and KTP laser   "
47052|NCT02669745|"     This study is experimental and will prospectively assess the proportion of patients in the     two (2) MammaPrint Risk categories in patients of Chinese descent.   "
46812|NCT02672891|"     Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics     emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for the     management of postpartum hemorrhage involve a stepwise approach including the exclusion of     retained products and genital tract trauma. Uterine atony, which is the most common cause, is     dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced     to arrest the bleeding is the uterine tamponade using various balloons and catheters. The     condom catheter uses a sterile rubber catheter fitted with a condom for uterine tamponade .   "
46813|NCT02672878|"     Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will     assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the     treatment of patients suffering from ISR.   "
46814|NCT02672865|"     The purpose of this study is to determine safety and tolerability of adjuvant hyperthermic     intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in subjects with locally     advanced gastric cancer undergoing standard surgical resection. Subjects will be treated with     HIPEC using a single dose each of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90     minutes, during the definitive surgical procedure for gastric cancer. HIPEC will be performed     after resection but before anastomosis.   "
46843|NCT02672488|"     Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got     much more attentions recently. It has been shown that metformin exerts anti-cancer activities     in several cancers, including primary liver cancer. In this phase II study, safety and     efficacy of the combination of metformin and sorafenib will be evaluated in patients with     advanced hepatocellular carcinoma.   "
46815|NCT02672852|"     This is a confirmatory, multicentre, randomized, double-blind, placebo controlled, 104 week     study with a 88 week treatment period and a 16 week follow-up period evaluating the efficacy     and safety of BI 655066 / ABBV-066 (risankizumab) to support Registration for the treatment     of moderate to severe chronic plaque psoriasis in adult patients. This study will also look     at the maintenance of response following randomly withdrawing treatment from those patients     responding to treatment at week 28, as well as the response to re-treatment for patients who     relapse. This study will also assess PK and emergence of anti-drug antibodies as well as the     influence of study treatment on disease specific markers. In a subset of psoriasis patients     with concomitant psoriatic arthritis, the signs and symptoms of psoriatic arthritis will be     evaluated to assess improvement.   "
46816|NCT02672839|"     The purpose of this study is to compare relative oral bioavailability of a capsule     formulation of LGD-6972 to a solution formulation of LGD-6972.   "
46817|NCT02672826|"     The endothelium is a key barrier between blood and tissue compartments. It is a major target     of factors involved in metabolic and cardiovascular pathologies. However, the study of native     human adult endothelial cells is difficult due to the lack of appropriate models and     thereafter the endothelium is actually not easily accessible for clinical investigation.     However, our results recently showed that the endothelium from human adipose tissue exhibit     distinct phenotypes, including endothelial cell number and inflammatory, angiogenic and     senescent state, according to adipose tissue location, i.e. subcutaneous and visceral. It is     well recognized that estrogens favour gluteo-femoral adipose tissue deposit and their deficit     after menopause is associated with increased abdominal and visceral fat mass as well as     metabolic dysfunctions. These perturbations might be prevented with hormonal therapy.     However, no data are available concerning the endothelial cells from gluteo-femoral and     abdominal adipose tissues in women.   "
46818|NCT02672813|"     The primary objective of this study is to access the effect of Pectoral nerve I and II blocks     in breast surgery as measured by consumption of postoperative morphine or its equivalent.   "
46819|NCT02672800|"     The purpose of this study is to evaluate the feasibility and acceptability of a writing     intervention (Reclaiming Yourself), intended to facilitate bereavement for spousal caregivers     whose partners died with dementia.   "
46820|NCT02672787|"     Despite great strides, hypertension remains an incredibly important disease and public health     problem. This study addresses this critical need among ED patients, a unique population of     patients who are (a) likely to benefit from an antihypertensive adherence intervention due to     their high prevalence of uncontrolled blood pressure and poor adherence, and (b) at high risk     for poor cardiovascular outcomes. The protocol provides for a multicomponent intervention     bundle to be tested among ED patients. Successful clinic-based behavioral interventions     generally target a combination of barriers to adherence; bundled interventions have shown     success in a wide range of settings and diseases. In some cases, bundled components were     necessary to achieve blood pressure benefit in a primary care setting; isolated educational     efforts have had mixed success in the ED.   "
46821|NCT02672774|"     The aim of the project is to study the role of minimally invasive imaging methods, such as     magnification endoscopy with narrow-band imaging (M-NBI) combined with confocal laser     endomicroscopy (CLE), in correlation with immunohistochemical analysis, for assessing the     angiogenesis status of patients with gastrointestinal tumors, in particular with colorectal     and gastric cancer. Angiogenesis, i.e. the process of forming new blood vessels, represents     an essential event for tumor growth and metastasis and the importance of its understanding     stems from potential applications for diagnosis, prognosis stratification and mainly from the     possibility of developing and improving targeted therapies. While current methods for     evaluating tumor vascularity are based on immunohistochemistry techniques with microvascular     density (MVD) calculations, these imply repeated tissue sampling and are not feasible in the     context of clinical practice. Imaging techniques might overcome limitations associated with     MDV measuring, obtaining both functional and morphological information and enabling repeated     evaluations that are necessary for the assessment of a dynamic process as angiogenesis during     follow-up of targeted therapies.      NBI is a digitally enhanced endoscopic imaging technique that uses optical filters to     illuminate tissue with light at blue and green wavelengths. These are selectively absorbed by     hemoglobin and, as a result superficial vascular networks are highlighted and morphological     changes in capillary patterns can be described for different lesions. CLE represents a     revolutionary technology that enables endoscopists to collect real-time in vivo histological     images or virtual biopsies of the gastrointestinal mucosa during endoscopy, and has raised     significant interest for the potential clinical applications and numerous research     possibilities. After intravenous administration of fluorescein as a contrast agent, CLE     enables real-time visualization of the tumor vasculature, which is structurally and     functionally altered compared to the normal vascular networks. Therefore M-NBI will be used     for enhanced visualization of morphological changes of the superficial capillaries, while CLE     will be directed towards vascular regions of interest for characterization of these changes     at the microscopic level. Furthermore, imaging studies will be backed by MVD calculation     using immunohistochemical methods, based on tissue samples harvested during endoscopic     procedures.   "
47474|NCT02664220|"     The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for     decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis.     Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal     irrigation.   "
46822|NCT02672761|"     Meditation improves attention and memory by reducing of the increased electric brain activity     induced by a high stress level. This is associated to neuroplastic changes (volume reduction     and/or neuron's density increases) in various brain structures. The question evolves if     memory improvement by a standardized meditation program of 8 weeks (Mindfulness Based Stress     Reduction MBSR) or a specific memory training (My Brain Training MBT) is a specific effect on     brain networking or mediated by a reduced general activity induced by stress reduction. Thus,     meditation or memory training should have differing neuroplastic effects.      The effects of memory function improvement by the respective training will be measured by     MAT, a specific and validated computerized memory and attention test. Brain morphology is     investigated by voxel based morphometry NMR before and immediately after an 8 weeks     intervention period. Stress levels are measured by cortisol profiles of subjects. Compared     were 4 groups- MBSR group- MBSR students after completed training, passive control group-     subjects following an 8 weeks waiting period for the MBSR training without any memory     training, active control MBT group- subjects on an 8 weeks waiting period for the MBSR     training doing an 8 weeks MBT memory training instead, Wellness group - doing a structured     program using relaxing massage and calming computerized chair (Brain Light).      The hypothesis of the study is that MBSR improves memory function better than MBT when     measured by MAT. Compared to both active and passive controls, MBSR training induces specific     morphologic changes in the brain, indicated by a volume change of the voxel based morphometry     method of 5% of a defined brain region. In comparison to smaller and less neuroplasticity     induced by MBT on memory brain regions, MBSR induces greater volume changes on hippocampus     and amygdala and stress reduction than the wellness program.   "
46823|NCT02672748|"     The Growing Resilience research leverages reservation-based assets of land, family, culture,     and front-line tribal health organizations to develop and evaluate home food gardens as a     family-based health promotion intervention to reduce disparities suffered by Native Americans     in nearly every measure of health. Home gardening interventions show great promise for     enabling families to improve their health, and this study aims to fulfill that promise with     university and Wind River Indian Reservation partners. The investigators will develop an     empowering, scalable, and sustainable family-based health promotion intervention with, by,     and for Native American families and conduct the first RCT to assess the health impacts of     home gardens.   "
46856|NCT02672306|"     The primary purpose of this study is to evaluate the safety and the efficacy of (Human     Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease     (AD).   "
46824|NCT02672735|"     The occupation of firefighting is considered to be one of the most dangerous occupations in     the United States (U.S.). As such, a high prevalence of musculoskeletal injuries (MSKIs) have     been observed among the firefighter population. This high rate of MSKI has created an     extremely large financial impact on fire departments across the United States. Therefore,     interest in developing methods of identifying those at risk for developing a future MSKI and     interventions designed to prevent these MSKIs from happening has grown among both the     firefighter population, as well as among researchers and practitioners.      Previous research has demonstrated relationships between MSKI and altered movement patterns.     In addition, researchers have started to demonstrate the ability of functional movement     assessments to predict future MSKI in various populations, including firefighters. Two of     these functional movement assessments include the Functional Movement Screen (FMS) and the     Movement Efficiency (ME) Test, which is a component of the Fusionetics Human Performance     System. These assessments both quantify the overall functional movement quality of an     individual by creating a composite movement score (i.e., Total FMS & Average ME Test scores,     respectively).      In addition, various theoretical models of corrective exercise programming have been     proposed. These programs are designed to restore optimal neuromuscular control and correct     any identified neuromuscular imbalances observed during the movement assessment through the     use of simple and easy-to-follow exercises. The Fusionetics Human Performance System utilizes     one such model, with the goal of improving the functional movement quality of an individual     by correcting the aforementioned neuromuscular deficiencies observed during the ME Test.     Based on this framework, these corrective exercise programs theoretically lower the risk of     MSKI of the individual as well.      However, there is currently a lack of research in the literature examining the influence of     corrective exercise programming on functional movement quality among the active-duty     firefighter population. As such, it remains unknown if a corrective exercise intervention is     capable of significantly improving functional movement quality among active-duty     firefighters. In addition, recent research suggests that various health and fitness measures     are associated with functional movement quality. These measures include total body power     output, lower extremity muscular strength, and core muscular endurance. As such, an     examination of the influence of a corrective exercise intervention on measures of health and     fitness among active-duty firefighters is warranted.   "
46825|NCT02672722|"     Renal parenchymal blood flow can be divided in cortical and medullary blood flow. Changes and     factors affecting renal medullary blood flow have not been studied in detail previously as     investigators/doctors did not have tools to monitor renal medullary blood flow in vivo. Since     Trueta first described renal medullary blood flow, multiple attempts have been made to study     renal medullary blood flow using invasive methods. Recently renal medullary blood flow     measurement using contrast US has emerged as a promising technique that investigators can use     to study renal medullary blood flow in vivo. In this study investigators are aiming to study     changes in renal parenchymal (cortical and medullary) blood flow with exercise in healthy     subject.   "
46826|NCT02672709|"     This study aims to determine the effects of end-stage renal disease on the pharmacokinetics,     pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label     pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for     nine days. The concentration of the drug will be measured with repetitive blood tests the     first and the eighth day of administration (non-dialysis days). The same blood tests will be     repeated before, during, and after dialysis on dialysis days. If the study shows inadequate     or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily     dose.   "
46827|NCT02672696|"     The aim of the study is to compare Tip-Apex Distance values in two groups of patients after     intramedullary nailing of proximal femur. The first group of patients is operated with the     help of a 3D reconstruction device connected to the standard fluoroscopy allowing the surgeon     to visualize directly the exact position of the tip of the trans-cervical screw while the     second group (which is the reference-group) is operated with the help of fluoroscopy alone.   "
46828|NCT02672683|"     The purpose of this study is to evaluate the level of expression of 4 circulating microRNAs     in the serum using RT-PCR. A pilote study with cardiac transplant patients has shown that     expression of these microRNAs could discriminate patients with a histologically proven     rejection from patient displaying a normal endomyocardial biopsy. The signature must be     confirmed in unselected patients and its stability evaluated according to clinical,     biological and immunological parameters of included patients.   "
46837|NCT02672566|"     Constituted vascular intrauterine growth restriction (CVIG) is correlated to an abnormal     placenta development, with an alteration of the maternal-fetal circulation, coagulation     troubles, and apparition of placental infarcts. CVIG represents the third cause of perinatal     mortality in France, and is associated to an important morbidity. For birth-weights < 10th     percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal     weights. 35% of CVIG are linked to vascular causes and are integrated in the placental     vascular diseases.      To answer this objective, researchers propose a multicentric clinical trial, randomized,     open, in two parallel groups, comparing the enoxaparin subcutaneous administration at     preventive doses associated to the usual care (group 1) versus the usual care only (group 2).     The inclusion of 81 patients per group is scheduled, meaning 162 patients in total.     Participation for each patient starts at the first consultation until 1 month after delivery.     Inclusion time is 22 months. Total duration is 26 months.   "
46829|NCT02672670|"     The aim of this proposed PhD study is to test the effectiveness of a newly developed     coping-oriented supportive programme (COSP) for Chinese people with SCI during their early     period of inpatient rehabilitation in Xi'an, China. The objectives of this study are to     develop and validate the COSP in the inpatient rehabilitation hospitals; and to evaluate the     effectiveness of this COSP for the SCI inpatients in two rehabilitation wards on their coping     abilities, self-efficacy, mood status, and life satisfaction, when compared to those     receiving routine care in another two rehabilitation wards. This proposed PhD study is a     quasi-experimental study, using repeated-measures, comparison group design. The study will be     conducted in two rehabilitation hospitals in Xi'an, China. There will be 50 patients in each     of the two study groups (i.e., one intervention and one comparison group). The intervention     group will receive the COSP including 8 weekly sessions, and the comparison group will     receive usual rehabilitation care in brief didactic group-based education. Outcome measures     will be examined at baseline and immediately, 1- and 3-month after completion of the     interventions. The primary outcomes of this proposed study are coping ability and     self-efficacy, while the secondary outcomes include mood status, life satisfaction, and pain.     All data will be analysed using SPSS for Windows, version 21.0. Descriptive statistics will     be employed for demographic and disease-related data and outcome scores. Data analysis for     intervention effects will be based on both Per-protocol (PP) analyses and Intention-To-Treat     (ITT). The missing data will be handled by the Last Observation Carried Forward (LOCF)     strategy. Inferential statistics will be conducted for between-group and within-group     comparison with specific considerations with the measurement level of the data and the     fulfillment of the statistical assumptions of parametric or non-parametric tests, and further     consider to use multivariate analysis of covariance (MANCOVA) or the analysis of covariance     (ANCOVA).This study will provide evidence on the clinical effectiveness of the     coping-oriented supportive programme in improving patients' psychological adjustment to SCI     during earlier stage of inpatient rehabilitation, enhancing their psychosocial adaptation to     the illness and subsequent life satisfaction and hence, integrating this psychosocial     intervention into the conventional treatment and SCI rehabilitation practices.   "
46830|NCT02672657|"     Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite     needs perceived by elderly patients might differ from those of younger patients, there is a     paucity of published data assessing the specific evolution and relevant determinants of     health-related quality of life (HRQoL) in older patients with cancer. Such determinants may     include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional     status or socioeconomic features, but also practical organization of care -frequency,     geographical distance, supporting measures -, or psychosocial and material support - social     network, housing conditions and contextual neighborhood features. Comparatively to dementia     or cancer in younger patients, little is known in the oncogeriatric field of the impact on     caregivers' perceived burden and HRQol of the support they provide to patients. Further, the     potential interactions between patients' and caregivers' HRQoL remain largely unknown, while     caregivers are often themselves old with chronic diseases and/or daily living activities'     limitations.      The DEQOLAGE study is a prospective observational cohort study that aims to describe the     HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first     year following the diagnosis of the disease as well as the HRQoL and burden in their main     caregivers. This study will allow a comprehensive assessment of multiple determinants of     HRQoL operating at different levels, including individual (cancer type/location/stage,     treatment type/intensity, comorbidities, nutritional status or socioeconomic features),     contextual (social network, housing conditions and contextual neighborhood features) and     organizational factors (frequency, geographical distance, supporting measures). We also     hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and     perceived burden. Quality of life measurement will be based on two recent scales specifically     designed for the elderly to confirm their psychometric properties and in-field feasibility.   "
46870|NCT02672124|"     The aim of this study is to evaluate the microbiological safety and the efficacy of a new not     expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro     Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure     and to avoid mismatches by ensuring the same results of the standard techniques in terms of     fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a     better euploid status of the embryos.   "
46831|NCT02672644|"     Study is designed to characterize subject and treating investigator reported outcomes in the     early post-treatment period, following bilateral correction of nasolabial folds using Emervel     Classic and Emervel Deep.        1. to evaluate subject-reported return to social engagement, after the initial treatment          (Baseline/Day 1 visit).        2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30-          subject/investigator reported        3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.        4. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to          post-treatment follow-up time points at day 14 and Day 30 - investigator reported        5. to evaluate all adverse events during the course of the study   "
46832|NCT02672631|"     The aim of this study is to determine whether clinical, sensory and motor development     correlated with the values obtained from Electroneuromyography and DTI in postoperative     follow up patients who underwent primary repair after the total median nerve injuries.      Median nerve is one of three major nerves of hand and forearm and often injure with glass     etc, in follow up of healing; clinical examination and ENMG are often used. Both of these     methods are subjective, noninvasive and objective new method is required. In this context;     differences between intact, recovering and not healed nerve tissue's diffusions have led to     the hypothesis; The recovery of the repaired nerve tissue can be monitored by Diffusion     Tensor Imaging method.   "
46833|NCT02672618|"     The purpose of this study is to explore manifestations of Heart Failure Using Infrared     Thermal Imaging Technology.   "
46834|NCT02672605|"     This study is a randomized controlled trial designed to measure abortion stigma related to     the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive     the validated Individual Level Abortion Stigma Scale either before or after consent via the     Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in     the two groups.   "
46835|NCT02672592|"     Obesity and the metabolic syndrome in men are associated with a high prevalence of     hypogonadism of up to 50%. Increased fat mass leads to augmented release of adipocytokines     and pro-inflammatory cytokines such as IL-1-beta, IL-6 and tumor necrosis factor-alpha which     in turn suppress the hypothalamic-pituitary-gonadal (HPG) axis, leading to hypogonadism. This     pathophysiological interplay is termed hypogonadal-obesity-adipocytokine hypothesis. TestIL     is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to test     the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on HPG axis     and increases testosterone levels in men with metabolic syndrome.   "
46836|NCT02672579|"     This purpose of this study is to validate two measures of chronic itching in kids: itch     severity (ItchyQuant) and the impact on their quality of life (ItchyQoL).   "
46838|NCT02672553|"     The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive     surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full     ster-notomy surgical approach.   "
46839|NCT02672540|"     Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive     crisis who are admitted to the hospital for treatment.   "
47053|NCT02669732|"     The objective of the study is to evaluate change in insulin secretory capacity in patients     with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral     administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In     addition, safety of this regimen will be examined in this study.   "
46840|NCT02672527|"     As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data     regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in     soft tissue sarcoma remain to be assessed.      For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival     data for patients with advanced or metastatic STS are of poor prognosis despite improvement     of results this last years. For example, median overall survival increased from 12,3 months     (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006).      Considering the latest results with and without Trabectedin, the investigators may consider     that comparing Trabectedin with best supportive care is ethically acceptable as long as     patients consent to enter the trial.   "
46841|NCT02672514|"     The aim of this study was to prospectively evaluate MECC compared with conventional     extracorporeal circulation of diabetic patients undergoing elective coronary     revascularization procedures. The investigators focused on the effects of extracorporeal     circulation especially the renal function between both groups.   "
46842|NCT02672501|"     In the conventional treatment options, B cell leukemia could be treated with chemotherapy     drugs or HSCT. But chemotherapy could barely cured leukemia. And HSCT is often limited by     lacking of HLA-matched donors, even if those patients who received HSCT still could be     relapsed. And now, chimeric antigen receptor modified T cell infusion maybe an effective     treatment to solve these problems. The investigators use a 2nd CAR- T with the optimized     hinge and transmembrane domain to treat patients with relapsed or refractory B cell leukemia,     including relapsed cases after HSCT. The purpose of this study is to assess the safety and     efficacy of this 2nd CAR-T cells. At the same time, evaluating the possible and clinical     responses of using donor-derived T cells engineered CAR-T cells.      Detailed Description: This study is being conducted to assess anti-CD19-CAR-T cells safety     and efficacy in treating patients with B cell leukemia. The investigators constructed a 2nd     CAR, CD19 as target protein, 4-1BB as co-stimulator. And optimized the spatial conformation     by a suitable hinge & transmembrane domain sequences. The source of T cells for CAR-T is from     two aspects, one is autologous, the other is donor-derived (only suitable for patients     received HSCT before and relapsed). The infusion dose is (1-5)×106 CAR positive T cells/kg,     and the specific cells numbers depend on the situation of individual CAR-T cells preparation.   "
46844|NCT02672475|"     This phase I trial studies the side effects and best dose of Galunisertib when given together     with paclitaxel in treating patients with androgen receptor negative or triple negative     breast cancer that has spread to other places in the body. Some tumors need growth factors,     which are made by the body's white blood cells, to keep growing. Galunisertib may interfere     with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving     Galunisertib together with paclitaxel may kill more tumor cells.   "
46845|NCT02672462|"     A single center, self-controlled pilot study on safety and efficacy of renal denervation in     treatment of hypertension.   "
46846|NCT02672449|"     The aim of this research project is to test the feasibility and safety of a new treatment     schedule for high risk prostate cancer that allows the administration of high doses to the     prostate tumor with a mixed beam approach of carbon ions boost followed by pelvic IMRT.   "
46847|NCT02672436|"     The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject     with diabetic foot ulcers.   "
46848|NCT02672423|"     The purpose of this study is to measure how much abemaciclib gets into the blood stream and     how long it takes the body to get rid of it when given as capsules versus a tablet(s). The     effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the     tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information     about any side effects that may occur will also be collected.      This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B     will last about 60 days including follow-up. Screening may occur up to 28 days before the     first dose of study drug. Participants are only allowed to enroll in one part.      This study is for research purposes only and is not intended to treat any medical condition.   "
46849|NCT02672397|"     The purpose of this study is to see if an educational intervention provided to pregnant women     in early labor has an effect on their decision to use epidural anesthesia for relief of labor     pain. The study will also investigate differences between Hispanic and non-Hispanic white     women in their attitudes and beliefs regarding epidurals in labor. Previous studies have     shown that Hispanic women receive epidural anesthesia in labor much less frequently than     their non-Hispanic white counterparts. The investigators hypothesize that the rate of     epidural use will be higher in subjects who receive the educational intervention than in     those who do not.      Women who have been admitted to the OHSU labor and delivery unit will be screened for study     eligibility. In order to minimize the influence of socioeconomic factors, only women     receiving Medicaid will be enrolled. Other inclusion criteria include age of at least 18     years, having a fetus of at least 24 weeks gestational age, and being categorized as American     Society of Anesthesiologist category 1 to 3. Exclusion criteria include any condition that     either excludes or mandates neuraxial anesthesia. Midwife patients are also excluded from     this study. Those who meet study criteria will be approached by a member of the study team     and informed consent will be obtained.      Subjects will be randomly assigned to receive an educational intervention about epidurals or     no educational intervention. Hispanic and non-Hispanic subjects will be randomized     separately, yielding four study groups (Hispanic - intervention; Hispanic - control;     non-Hispanic - intervention, non-Hispanic - control). The investigators expect to enroll     approximately 176 women, 44 in each group.      All subjects will complete a survey in early labor and again 1 to 2 days postpartum that asks     about common beliefs and misconceptions regarding epidurals. Subjects in the intervention     group will receive an educational pamphlet and watch a video in their native language     (spanish or english) about epidurals, and have an opportunity to ask questions. Study staff     will collect limited information about the subject's labor and delivery from the electronic     medical record.   "
46850|NCT02672384|"     This study evaluates the diagnostic performances of Point of Care P. gingivalis test in     saliva with serum IgG P. gingivalis, in reference to dental examination as a gold standard in     patients hospitalised in intensive care unit (ICU)   "
46851|NCT02672371|"     The study is a randomized clinical trial that is assessing the effects of sensory training on     pain modulation, cognition, and physical endurance (time to fatigue) in healthy participants   "
46864|NCT02672202|"     To create a data base that will facilitate the enrichment of the insights regarding     post-operative pain development, and to identify those individuals with the potential to     develop this kind of pain. The identification will be based on the individualized pain     modulation profile, composed of a battery of tests as detailed below.   "
47054|NCT02669719|"     This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC     (dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in     patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal     growth factor receptor).   "
46852|NCT02672358|"     This is an open-label, multicenter, non-randomized, single arm, phase II study to assess     efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with     any line, stage IV NSCLC harboring a confirmed BRAF V600E mutation.      Patients will receive oral dabrafenib twice daily and oral trametinib once daily combination     therapy. Patients may continue study treatment until disease progression, unacceptable     adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the     study. Patients who have met the criteria for disease progression (PD) according to RECIST     v1.1 may continue to receive study treatment if the investigator believes the patient is     receiving clinical benefit and the patient is willing to continue on study treatment. After     discontinuation of study treatment, all patients will be followed for survival until death,     lost to follow-up, withdrawal of consent, or end of study.   "
46853|NCT02672345|"     Cardiac surgery has evolved considerably after the advent of cardiopulmonary bypass (CPB), a     feature that allowed more precision and tranquility to the heart surgeon. But their influence     on exacerbation of inflammatory response can unbalance the whole homeostasis so happens     surgical trauma. The attenuation of the systemic inflammatory response in major surgeries     like cardiac surgery for aortic aneurysm appears to represent an important advance in     reducing morbidity and mortality of these patients. Some studies suggest that inhaled     anesthetics such as sevoflurane appear to play an important role in this control, but the     mechanism by which this happens is still unclear. This study has the primary purpose of     analyzing from a clinical study sevoflurane inhalation anesthetic can change the inflammatory     response induced by CPB, significantly reducing the release of inflammatory markers,     especially elastase PMN.   "
46854|NCT02672332|"     This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel     group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.   "
46855|NCT02672319|"     Bleeding from gastroesophageal varices is one of the major complications of cirrhosis. After     successful treatment of the acute bleeding episode, patients who do not receive follow-up     treatment to prevent rebleeding were reported to have a rebleeding rate of 60% within 1- 2     years. The presence of liver cancer and/or portal vein thrombosis has been associated with     recurrent variceal bleeding. In a study of liver cancer patients in Hong Kong, 7.9% of     patients developed at least 1 episode of variceal bleeding over the course of liver cancer.      In patients with portal hypertension from cirrhosis, current guidelines recommend     non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial     bleeding, and either cyanoacrylate injection for variceal obturation or transjugular     intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is     unclear whether the above strategies will have the same clinical effect for patients with     liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding.      Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection     for variceal obturation has been described. In a study of patients with gastric variceal     bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all     patients and 96% of the gastric varices remained obliterated during the follow-up period. To     date, there has been no dedicated study to evaluate the role of EUS guided glue injection for     prevention of future bleeding in patients at high risk for recurrent variceal bleeding such     as those with liver cancer or portal vein thrombosis.      The investigators propose this study to evaluate the feasibility and safety of EUS guided     glue injection for follow-up variceal treatment in patients at high risk for recurrent     variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.   "
46857|NCT02672293|"     Over 20 million people in North America (including 2 million Canadians) have chronic kidney     disease. These individuals die from diseases of the heart and blood vessels more often than     they need dialysis. This is due to hardening of the arteries caused by calcium deposits     inside the blood vessel walls. These deposits damage the vessels, causing them to lose     flexibility. This makes them unable to respond to the changing demands of the body, and     eventually leads to blockages such as stroke and ultimately death.      High levels of phosphate in the blood have been consistently linked to the development of     calcium deposits inside blood vessel walls. The kidney is the only organ in the body that can     eliminate phosphate that is not required by the body. As kidney function becomes worse, body     levels of phosphate increase. However, investigators do not know the time point in the course     of kidney disease that problems begin in the way phosphate is eliminated into the urine by     the kidneys. Investigators will test the response of the kidneys to a phosphate challenge     taken by mouth in subjects who are having accurate measures of kidney function performed by a     method called 'inulin clearance'.      The investigators believe that the results of this study will provide important information     identifying when investigators should be concerned about body levels of phosphate increasing.     This information may lead to changes in the way investigators treat patients by reducing the     levels of phosphate in the diet at a much earlier time point then is presently recommended.   "
46858|NCT02672280|"     The purpose of the present study is to evaluate the safety and exploratory efficacy of the     medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment     of patients with skin defects.   "
46859|NCT02672267|"     The purpose of this study is to assess the safety, tolerability and preliminary efficacy of     human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered     intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).   "
46860|NCT02672254|"     The gold treatment for local invasive cutaneous squamous cell carcinoma is surgical excision.     Nevertheless, surgery is not always an option as a consequence of the age and/or the health     status of the patient. One of the objectives of this study is to assess the effects of     cisplatin concomitantly with a subsequent low-energy X-rays irradiation in vitro. In order to     enhance the effectiveness of this combined treatment, the temporal fractionation of the     platinated compound is expected to be performed.   "
46861|NCT02672241|"     The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in     combination of radio-chemotherapy for the treatment of brainstem tumor in children.   "
46862|NCT02672228|"     This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble     technology (MalariSense) for malaria diagnostics. The MalariSense technology will use a     highly innovative approach based on the transdermal non-invasive detection of vapor     nanobubbles produced by the excitation of malaria-specific hemozoin by safe, low-energy laser     pulse. The objectives of this study will be to determine the sensitivity and specificity of     MalariSense in diagnosing malaria in malaria suspected cases attending a health facility in     The Gambia and to identify factors influencing the diagnostic accuracy of MalariSense   "
46863|NCT02672215|"     A theory-driven, web-based, computer-tailored advice to influence sitting at work was     developed. The study investigated the effects of this computer-tailored intervention to     influence workplace sitting on behavioural measures.   "
48198|NCT02654743|"     This is an open-label, 4-month study examining the effects of Sulforaphane (SF) on behavior     in children with ASD and the correlation between behavior change and urinary metabolites. The     goal is to determine a potential mechanism of action of SF in this population.   "
46865|NCT02672189|"     The current study will evaluate systematically the efficacy and cost-effectiveness of two     internet-based CBT/relaxation programs (one guided, the other self-managed) in reducing the     severity of menopausal symptoms and improving copings skills with regard to hot flushes and     night sweats as well as improving sexual functioning, improving quality of sleep, reducing     emotional distress and improving quality of life in younger breast cancer patients who     experience treatment-induced menopause.   "
46866|NCT02672176|"     The overall goal of this proposal is to enhance the supports and resources available to     patients with diabetes to assist them to achieve their health goals. The investigators will     evaluate an innovative program that uses nurse health coaching, motivational interviewing     techniques, wireless sensors and mobile health (mHealth) technology. In this program,     patients will receive timely, tailored nurse coaching feedback to facilitate behavior change     using mHealth technology, thus bridging bidirectional exchange of meaningful information     among patient, nurse coach and provider. The investigators will conduct a randomized     controlled trial among patients receiving chronic disease management at the University of     California, Davis Primary Care Network. The patients who are eligible for inclusion in the     study will be randomized to one of two arms of the trial: 1) Usual care (Care Coordination)     administered by UC Davis Health Management and Education; or 2) the Patient and Provider     Engagement and Empowerment through Technology (P2E2T2) Program to Improve Health in Diabetes.     The hypothesis is that patients in the P2E2T2 arm of the study will be more engaged in     identifying and achieving health goals related to their diabetes and will achieve better     health outcomes compared to patients receiving usual care.   "
46867|NCT02672163|"     This study aims to evaluate the safety and clinical feasibility of epicardially delivered     autologous atrial appendage micrografts in the treatment of heart failure. The micrografts     consisting atrial-derived cells and their extracellular matrix, are placed on an infarction     scar during CABG surgery.   "
46868|NCT02672150|"     This is a multi site experiment to evaluate the impact of various strategies for increasing     the use of evidence based screening, assessment and linkage to substance use treatment. All     sites collect baseline data and receive a core intervention. Half are then randomly assigned     to get an additional year of coaching to facilitate implementation.   "
46869|NCT02672137|"     Cluster randomized open-label experimental study multi-center of 24 hospitals to either     knowledge translation vs usual care to improve care of patents hospitalized for acute     coronary syndromes.   "
46871|NCT02672111|"     Open-label multi-center, 12-month safety study, consistent with standard practice for     long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly)     and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.   "
46872|NCT02672098|"     This is a phase I prospective study with the primary objective to compare the efficacy and     safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)     in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible     patients consenting to this protocol will undergo their scheduled surgical procedure. After     surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of carboplatin (800     mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using     the closed-abdomen. HIPEC will be continued for 90 minutes in the hyperthermic phase     (41°C-43°C). At 4-6 weeks after CRS, patients will go on to receive 6 cycles of standard IV     platinum-based chemotherapy. The proportion of patients who are without evidence of     recurrence will be assessed at 6, 9, 12 and 18 months after the day of surgery.   "
46873|NCT02672085|"     Background and Rationale:      Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It has     been showed effective in different parts of the body, but current evidences for rotator cuff     PRP infiltration remains poor. Some studies that tested infiltrations on transfixing lesions     showed no statistically significant effect of PRP on tendon healing. The investigators     believe that this might be explained by a flushing effect of PRP into subacromial space or     glenohumeral joint. Therefore, it was decided to focus this study on interstitial lesions, in     which PRP is entrapped into the lesion for a long time.      Objective:      The purpose of this study is to evaluate whether intra-tear PRP infiltrations promotes tear     repair better than needling procedures of torn tendon in participants with supraspinatus     interstitial tears.      As secondary objective, we will study symptoms alleviation in same way. Primary outcome:     Primary outcome: Supraspinatus tear size change from baseline will be compared between cases     receiving two PRP injections and controls receiving torn tendon needling, 6 months after     second injection.      Secondary outcomes: Single Assessment Numeric Evaluation score, Constant score, ASES score,     Shoulder pain disability index, and Visual analogue scale changes from baseline will be     compared between cases receiving two PRP injections and controls receiving torn tendon     needling, 0,1,3, and 6 months after second injection.      Study design: This case-control study is randomized 1:1 between PRP (intervention group) and     needling (Control group). It is a superiority trial that will include 84 patients suffering     from interstitial supraspinatus tears. As adjuvant therapy, patients from each arm will     beneficiate from standard physical therapy program. PRP and needling will be repeated 2     times, at one month interval. First injection will occur up to two months after recruitment.     Clinical follow-up will occur from second injection to one year after second injection, with     clinical parameters evaluation at 0,1,3, and 6 months after second injection, and control MRI     6 months after second injection.      Study Product / Intervention: Supraspinatus tendon needling with intralesional PRP injection.     PRP will be extracted with Regenlab® extraction kit. No other medications used.      Control Intervention (if applicable): Supraspinatus tendon needling with intralesional saline     water injection.      Number of Participants with Rationale: 84 patients will be needed (37 in each group). A 10%     of dropout has been taken in consideration.      Study Duration: 24 months from recruitment of the first patient to the last follow-up visit.     Scientific report will be written within the two months following recruitment of the last     patient.      Study Schedule: First-Participant-In: 01.6.2015 Last-Participant-Out: 30.6.2017   "
46874|NCT02672072|"     I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined     as the presence of job strain as defined by Karasek.      II. Main secondary outcomes        -  ICU nurses stress at one year        -  Burnout        -  Intent-to-leave the ICU        -  Quality of life      III. Design      Prospective, randomized, open study comparing 2 groups of ICU nurses:      Simulation group and Control group      Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to     take into account differences between the ICUs regarding organization, activity, patients…).      This study is observational because nurses can participate to this training when they want.     The fact that nurses are in control group delays their participation to this training but     does not forbid them to particpate. The nurses from control group will participate to     training at the end of study.      IV. Specific measures Control group: none      Simulation group: 5-day specific training with dedicated scenario done by an ICU expert     simulation team      V. Study duration 48 months      VI. Ethical aspects - Reglementary concerns        -  Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière          de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de          l'Informatique et des Libertés (CNIL)        -  Information to the participants prior inclusion      VII. Study population Job strain evaluated in a French study was 59% . The same rate was     observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We     therefore hypothesized that the intervention (simulation) should be able to reduce the job     strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this     study needs to include 185 patients per arm. To take into account few participants who will     not complete the study, we aimed to include a total of 400 ICU nurses.   "
47498|NCT02663908|"     The purpose of this trial is to test if a marketed drug for advanced prostate cancer     (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another     marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer     and cardiovascular disease.   "
46875|NCT02672059|"     In the context of peripheral neuropathy, we will aim to elucidate correlates between sensory     symptoms and:        -  Sensory nerve dysfunction.        -  Cutaneous small nerve fibre innervation density.        -  Psychological co-morbidity.        -  Circadian rhythm disturbance co-morbidity.        -  Functionality and Quality of life.        -  Patterns of human brain activity in a subset of patients that consent to participate in          the FMRI (functional magnetic resonance imaging) component of PINS.           2. We will also collect blood samples in this phenotyped cohort of patients. These blood          samples coupled with detailed phenotype data will investigate potential gene          associations only in the development of painful neuropathy.           3. Knowledge gained from the study will be used to aid the further development of pain          questionnaires, designed to detect patients with painful neuropathy.           4.Knowledge gained from the study will be invaluable in informing on-going          investigations of painful peripheral neuropathy in animal models, both in our laboratory          and others.   "
46876|NCT02672046|"     The aim of the study is to evaluate an algorithm to screen patients with a possibility of     meniscal injury referred to a sports injury outpatient clinic by using patient-reported     symptoms. It will be investigated whether the algorithm is able to identify which patients     are deemed relevant to undergo assessment by a physician (i.e. in case the patient need to     undergo surgery) and which patients are relevant to undergo assessment by a physiotherapist.     This will be evaluated by estimating the sensitivity of the new algorithm compared to actual     relevancy based on the traditional clinical assessment of the patients.   "
46877|NCT02672033|"     This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately     before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin     layer of tissue that covers the lungs and lines the interior wall of the chest cavity).     Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.     Hypofractionated radiation therapy is a type of radiation therapy in which the total     prescribed dose of radiation is divided into fewer but larger doses as compared to     conventional radiation therapy. Giving accelerated hypofractionated radiation therapy     immediately before surgery may improve survival, and may also reduce side effects experienced     by patients with pleural mesothelioma.   "
46898|NCT02671747|"     The study is to pilot-test an innovative, combined urinary/bowel continence workshop in two     Wisconsin communities. Between 8-15 women with incontinence will be enrolled in each of the     two pilot communities and will complete three 90-minute workshop sessions over a 6 week     period.   "
46899|NCT02671734|"     The investigators employed a randomized control study design to evaluate the efficacy of a     video intervention augmenting informed consent discussions in improving parental and youth     informed consent comprehension.   "
46900|NCT02671721|"     The purpose of this pilot study is to identify the optimal way to ventilate patients during     abdominal surgery in order to reduce the amount of post-operative pulmonary complications in     patients at moderate and high-risk for them.   "
46878|NCT02672020|"     Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two     rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers     improved thanks to the French COMETE network originally based on two clinical centers (HEGP     and Cochin) well organized for clinical and biological samples collection. Over the last 10     years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and     oncogenesis of these tumors and identified molecular signatures discriminating between benign     and malignant cancers by integrated genomic approaches. This strategy was highly successful     in delivering new diagnostic applications of genomics technologies that now appear as     potentially suitable for rapid implementation in routine clinical care.      The main objective of COMETE-TACTIC is to provide an easy-to-use identity card of the     adrenal tumors that will allow a personalized à la carte management of the patient and,     when indicated, to the indication of the most accurate molecular targeted therapy.      We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options     proposed to affected patients will require,        1. the transfer to routine practice and the prospective validation of the novel diagnostic          and predictive biomarkers issued from recent discoveries (genetics, genomics,          histological biomarkers);        2. the implementation of the translational research projects based on the COMETE collection          to identify circulating diagnostic, prognostic and therapeutic genetic and metabolic          biomarkers that could be used as non-invasive liquid biopsies.   "
46879|NCT02672007|"     This study aims to investigate these research questions:        1. Is there a difference in the results obtained, when respiratory rate is measured          automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)          compared with a research assistant using a criterion standard approach?        2. Is there a difference in the results obtained, when respiratory rate is measured          automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)          compared with hospital staff's current clinical practice?   "
46880|NCT02671994|"     In a randomized controlled trial, the investigators wish to investigate, if oncologic     treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT,     if needed, in older frail patients with gynaecologic and urologic cancer is superior to     standard assessment (PS and clinical assessment) in oncologic treatment decision.   "
46881|NCT02671968|"     Demonstrate that usage of RT-CGM (Real time continuous glucose monitoring) reduces the     frequency of low CGM-recorded glucose events in patients using MDI (Multiple daily     injections) that are at risk for hypoglycemic events.   "
46882|NCT02671955|"     The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in     participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for     further evaluation in specific tumor types.   "
46883|NCT02671942|"     To evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD     patient.   "
46910|NCT02671591|"     The overarching goal of the proposed study is to determine effective outreach methods     designed to recruit and improve acceptance of high-risk HIV-negative YBMSM to initiate PrEP     and to identify and modify psychosocial and structural predictors of PrEP acceptance.     Specifically, the objective of this pilot study is to test the feasibility of a motivational     interview-based intervention designed to improve PrEP acceptance among YBMSM.   "
46884|NCT02671929|"     The purpose of this study is to determine the feasibility and effectiveness of an     internet-based self help program concerning satisfaction with the treatment and their life,     depression and anxiety. Both study groups get access to the internet-based self-help program.     The intervention group receives additional feedback to their progress in the program from an     online therapist. The investigators hypothesize that (1) at least 75% of the patients in the     intervention group are satisfied or very satisfied with the self-help program, (2) 50% of     the patients in the intervention group work with all eight units and (3) patients of the     intervention group have a higher emotional competence than the patients of the control group     at the end of the self-help program.   "
46885|NCT02671916|"     The goal is to capture the Quality of life and survival of patients one year after the stay     at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the     ICU stay patients will be send a Quality of Life questionnaire they need to fill out and     return. All data will be evaluated together.   "
46886|NCT02671903|"     This is a multi-centre, prospective randomised double-blinded cross over study, recruiting a     sub-population of patients with heart failure.      All patients will be implanted with a CRT (Cardiac Resynchronisation Therapy) pacemaker with     one of the leads positioned on the His bundle in order to obtain direct His-bundle capture.     There will be a 2-month run-in period where the device is not active.      A double-blinded cross-over design will then be employed to investigate the effect of His     bundle pacing. Patients will be allocated in random order to six month treatment periods in     each of the following two states (1) No pacing; (2) AV optimised direct His-bundle pacing.     Endpoint measurements will be taken at baseline, 6 months and 12 months post randomisation.     Treatment allocation will be blinded to the endpoint assessor and the patient.      126 patients will be needed to detect the expected effect size on the primary endpoint with     90% power. A total of 160 patients will be recruited to allow for patient drop-out.   "
46887|NCT02671890|"     This partially randomized phase I trial studies the side effects and best dose of disulfiram     when given together with gemcitabine hydrochloride in treating patients with a solid tumor     that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to     other places in the body (metastatic) and to compare whether disulfiram and gemcitabine     hydrochloride may reduce tumor induced muscle loss. Weight loss occurs in pancreatic cancer     patients and is common in a multitude of other cancers. Patients with metastatic cancer and     weight loss sometimes are not able to receive treatment due to physical weakness or debility.     Disulfiram is a potential inhibitor of muscle degradation and may reduce tumor induced muscle     wasting. Disulfiram may also help gemcitabine hydrochloride work better by making tumor cells     more sensitive to the drug. Drugs used in chemotherapy, such as gemcitabine hydrochloride,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. It is not yet know whether     giving gemcitabine hydrochloride with or without disulfiram is a better treatment for     unresectable solid tumors or metastatic pancreatic cancer.   "
46901|NCT02671708|"     Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to     allogeneic HSCT for low-risk and intermediate-risk acute myeloid leukemia (AML) without     HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT     remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY     myeloablative conditioning regimens in low-risk and intermediate-risk AML undergoing     auto-HSCT are evaluated.   "
46888|NCT02671877|"     The aim of this study is the evaluation of preoperative transnasal fiberoscopy, as a possible     predictor of difficult laryngoscopy and intubation during elective general anesthesia in an     adult population.      Transnasal fibercoscopy is a minimally invasive examination and is routinely performed during     ENT evaluation; on the other hand, current strategies used to predict the ease of intubation     are still not sufficiently sensitive and specific, and an unexpected difficult or failed     intubation at the induction of general anesthesia is a seriuos, and potentially fatal,     emergency in anesthesia.      In literature, a correlation between anatomical and functional parameters highlighted by     fiberoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor     indagated.      If proven, this might give the Anesthestiologist further information about the expected     difficulty of laryngoscopy and intubation, guiding a different - and hopefully safer -     anesthesiological strategy.   "
46889|NCT02671864|"     Experimental data suggest that GLP-1 promote endothelial cell growth and angiogenesis which     may have beneficial effects on the cardiovascular system but harmful effects on the retina .     This project investigate the possible link between incretin therapy and Severe Diabetic     Retinopathy. The prevalence of severe DR in patients exposed to incretin therapy (GLP-1     analogs or DPP4 inhibitors) is compared to that in non-exposed patients to these antidiabetic     classes.   "
46890|NCT02671851|"     Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative     analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.      Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA)     could postpone time to first pain and improve postoperative analgesia in patients undergoing     bilateral reduction mammoplasty.      Design: A historical cohort study. Patients: Of the 70 female patients who underwent     bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional     anaesthesia database.      Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four     patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine     0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were     administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20%     above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit     (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g     and/or paracetamol 3x1g on wards (NRS≥4).      Main outcome measures: The primary endpoint was time to first pain after the surgery.     Secondary endpoints were intra- and postoperative opioid and other rescue analgesic     requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and     vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.   "
47536|NCT02663401|"     This study evaluates the impact of the introduction of a front-of-pack nutrition label on     fods and beverages sold in a campus cafeteria in France on the nutritional quality of     purchases. The design involves one site with the intervention and one control site with the     same consumer and product characteristics.   "
46891|NCT02671838|"     Non-adherence to medications can lead to sub-optimal treatment in rheumatoid arthritis (RA)     patients. In order to improve disease modifying anti-rheumatic drugs (DMARDs) adherence, the     investigators are conducting a randomized controlled trial to test out an intervention to     improve medications adherence among low adherers. This intervention involves the use of a     musculoskeletal ultrasound program which allows RA patients to visualize their joint     inflammation and damage real time while treatment adherence is simultaneously reinforced. In     doing so, the investigators hope to improve patients' understanding of their joint disease     and motivate the participants to adhere to their medications.   "
46892|NCT02671825|"     The purpose of this study is to compare drug blood levels of multiple formulations of inhaled     PUR0200 to each other and to the reference product with and without oral charcoal.   "
46893|NCT02671812|"     The general aim of this project is to investigate the long-term treatment outcome after     implant therapy. The patients' satisfaction with implant treatment will be studied and     correlated to biological and technical problems. The survival rates of implants at patient     level and the degree of bone loss of remaining teeth and implants will be calculated. The     levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects     and at healthy sites will be analyzed in order to study the correlation between cytokine and     bone loss marker levels, and clinical conditions. Independent variables which could be     regarded as significant risk factors or risk predictors on the incidence of peri-implantitis     are aimed to be identified   "
46894|NCT02671799|"     This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for     treatment of moderate to moderate-severe functional mitral valve regurgitation [FMR].   "
46895|NCT02671786|"     Provision of community based health care to severely malnourished children (Age group: 6     months through 5 years) in 16 tribal villages by trained semi-literate village health     workers.        1. Treatment of severely malnourished children.        2. Growth monitoring of all children below the age of 5 years.        3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.        4. Management of resistant or relapsed severely malnourished cases by pediatrician.        5. Intensive behavior change communication of parents of children below the age of 5 years          for proper nutrition.   "
46896|NCT02671773|"     Previous work has determined that there are significant differences in the communities of     bacteria found in the airways of asthmatic patients compared to those found in the airways of     healthy people.      It is not yet clear if these bacterial communities are similar in all patients with asthma or     if they are different in people with more severe asthma, with different types of asthma or     between asthma patients taking different treatment. This is important to know as any     differences in the bacteria present between groups may help to explain why people with asthma     do not have the same features of disease.      This research aims to determine if there are any differences in the number and type of     bacteria found in the airways of asthmatic patients (1) with different severities of asthma     and (2) who use different types of inhaled steroid treatment for asthma.      We will do this by detecting the DNA of bacteria present in phlegm samples from these     patients. We will also take measurements of the different components of asthma to see if the     bacteria are different in people with different types of disease.      As it is not yet clear if the bacteria detected in phlegm samples from one person may differ     on different occasions, we will be taking more than one sample from some patients to see how     similar this is over time.   "
46897|NCT02671760|"     The purpose of this study is to evaluate the effect of a combination drug product containing     diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who     sometimes have difficulty falling asleep or staying asleep, but who do not have chronic     insomnia. The study involves 3 one-night stays in a sleep center in New York City.   "
46904|NCT02671669|"     This is a randomized controlled trial of the feasibility and utility of implementing a     smartphone application (MVN) to maintain compliance with a Heart Healthy lifestyle after     discharge from a cardiac outpatient rehabilitation program. Patients will be randomized into     one of two groups: usual care (control: UC) or Movn mobile application (intervention: MVN).     This study will improve and strengthen data collection from this at-risk patient population     by recording baseline clinical and psycho social measures while gaining insight into     self-reporting of physical activity and frequency between the UC and MVN groups.   "
46905|NCT02671656|"     Lowering the level of uric acid in the serum under 6mg/dL on the long term is a key factor of     gout management success. Monitoring of uricemia in gout patients is therefore important and     is presently done in the laboratory on serum samples obtained after venous puncture. This     study aims at assessing the reliability of immediate uricemia measurement in a blood sample     obtained by a mere fingertip puncture, by the HumaSensplus system, which is commercially     available in the EU. Results obtained by the Humasens device will be compared to those of the     standard measurement technique in serum and with a reference technique (liquid chromatography     and mass spectroscopy). If the device appears reliable, it will allow self-measurement of     uric acid by the gouty patient, in a similar way as diabetic patients measure their glycaemia     following a fingertip puncture. This should improve patient monitoring and management     effects.   "
46906|NCT02671643|"     Purpose: To determine the measurement properties of the asthma control test (ACT) in a     prospective clinical study in an African American adolescent population.   "
46907|NCT02671630|"     Little is known about the effects of computerized cognitive training programs on mild     dementia patients' health. The purpose of this study was to examine the effects of a     community-based computerized cognitive training program.   "
46908|NCT02671617|"     This randomized control trial will determine the effect of short term high intensity interval     training (HIIT) on physical fitness, in an elderly patient group with active cancer, prior to     surgical resection.      Half of the recruited patients will act as a control group and the other half will undergo a     HIIT protocol.   "
46909|NCT02671604|"     In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum,     intraoperative fluid restriction and prolonged Trendelenburg position may cause     rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.      In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative     positioning, fluid restriction and length of surgery on development of RM in RARP patients     during perioperative period.   "
46911|NCT02671578|"     BACKGROUND: The degree of consciousness during nitrous oxide use is still a matter of concern     for both dentists and anesthesiologists. Investigators hypothesized that BIS levels do not     vary according nitrous oxide concentration during minimum to moderate sedation in the dental     treatment.      METHODS: One hundred patients undergoing dental procedures demanding local anesthesia (1.8 mL     of 2% lidocaine with 1:100.000 epinephrine) were enrolled in this study. Initial pain and     anxiety were measured by 11-point numerical and anxiety visual scales, respectively.     Systolic/diastolic arterial blood pressure, SpO2, heart and respiratory rates, and     psychomotor ability (Trieger test) were assessed before, during and after dental treatment.     Sedation levels were evaluated by both BIS and sedation analogic scale at the same intervals.     The duration of treatment along with nitrous oxide concentration and side effects were     observed. Kruskal-Wallis, Friedman and Mann-Whitney tests were used (alpha=5%).   "
46912|NCT02671565|"     Osteoarthritis (OA) is a degenerative joint disease in which there is an imbalance between     the breakdown and repair of the joint tissue. Intraarticular hyaluronic acid (HA) injections     are used for the management of knee OA. Currently, there is limited and inconclusive evidence     supporting use of HA injections for management of knee OA. The primary objective of our study     is to evaluate the effectiveness of HA injections in the management of knee OA. Investigators     will evaluate if HA injections prevent or delay knee OA surgical interventions.   "
46913|NCT02671552|"     This pilot clinical trial compares the imaging results of contrast-enhanced ultrasound to     contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT), the current     clinical standard, in predicting treatment response in patients with kidney cancer undergoing     cryosurgery (a procedure in which an extremely cold liquid or an instrument called a     cryoprobe is used to freeze and destroy abnormal tissue). Using contrast-enhanced ultrasound     that does not involve a dye may help patients avoid side effects from a dye that is usually     used in MRI or CT and may help doctors measure blood flow and determine whether the     cryosurgery procedure treated the kidney tumor.   "
46914|NCT02671539|"     An open label monocentric phase II trial in adult males with a clinical phenotype of     choroideremia and a confirmed molecular diagnosis of a null mutation in the gene encoding     REP1 to assess the anatomical and functional outcomes, as well as the safety of a single     subretinal injection of rAAV2.REP1 in 6 subjects with genetically confirmed choroideremia for     up to 24 months.   "
46915|NCT02671526|"     This study is a validation study to document the acceptability of the revised     Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with     HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to     evaluate the effects of the revised PACR program on the cognitive abilities (e.g., attention,     executive function), functional status and quality of life of individuals diagnosed with     HAND. The secondary objective of the study is to collect relevant data to support a     pre-investigational device exemption (IDE) submission to the FDA required before the pivotal     randomized, controlled trial planned for Phase II.   "
46916|NCT02671513|"     SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor. The purpose of this     study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in     Chinese advanced melanoma patients by using a 3+3 dose escalation.Preliminary efficacy will     be also investigated in this study.   "
46919|NCT02671474|"     A single-center prospective interventional trial. Patients implanted with a sutureless     bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012     will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be     performed. The aim of the CT is to assess valve leaflet motion. Results of the CT     examination, preoperative clinical characteristics, and postoperative clinical data will be     registered. Data will be collected prospectively and retrospectively. Informed consent will     be obtained from patients meeting the inclusion criteria before the initiation of any     study-specific procedures.   "
46920|NCT02671461|"     The purpose of this study is to determine whether BMS-986141 is effective in reducing the     recurrence of stroke in people who recently had a stroke, or a transient ischemic attack     (known as a TIA or mini stroke) and are receiving acetylsalicylic acid (also known as     aspirin or ASA) to treat the stroke or TIA.   "
46921|NCT02671448|"     In this study, the investigators plan to see what happens when a person receives care in the     home setting. They want to find out if caring for a patient who has been treated with an ASCT     in the home setting is feasible. They want to find out what effects good and/or bad this will     have on the patient's recovery and treatment after ASCT. Studies in other institutions have     shown that providing care in the home setting after ASCT is safe, increases patient     satisfaction, and can decrease the risk of infection. It is our hope that this new approach     of providing care in the home setting will prove to be a feasible and safe option for     patients at Memorial Sloan Kettering Cancer Center (MSK).   "
46922|NCT02671435|"     This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the     safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of     Durvalumab (MEDI4736) in combination with IPH2201 in Adult Subjects with selected advanced     solid tumors.   "
46923|NCT02671422|"     At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage     of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of this     NIS is to examine whether genetic/genomic markers (alone or combined with clinical     covariates) could be used to predict OS in NSCLC patients eligible for treatment with     Vargatef®. The investigations in this study are exploratory in nature and considered to be     hypothesis generating. The results from these investigations may help to expand our     understanding of the disease and the response to Vargatef®.   "
46944|NCT02671149|"     The aim of this study is to determine whether drinking plain water when mildly dehydrated     benefits cognitive performance and mood. Volunteers undergo a dehydration protocol designed     to result in minor dehydration. While some participants receive two 150ml drinks of water     others do not. Differences in cognitive functioning are assessed.   "
47055|NCT02669706|"     The main objective of this study is to assess the safety of administering intravenous (IV)     pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with     hematologic malignancies and stem cell transplant recipients. There will also be an     assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic     therapy.   "
46924|NCT02671409|"     The spinal nerve injury in humans often results in neuropathic pain characterized by     spontaneous burning pain accompanied by allodynia and hyperalgesia. In this sense,     lomboisquiatalgia is a neuropathy that is characterized by narrowing the intervertebral     foramen of the lumbar vertebrae, leading a lumbar chronic pain which irradiate to a lower     limb, being a clinical condition of difficult treatment. Neural Mobilization is a noninvasive     technique used by physiotherapists. The technique aims to restore mobility and elasticity of     the peripheral nervous system by tenses which are imposed on the roots, nerves, spinal cord     and their respective meninges. This technique has been standardized in basic research and has     shown promising results. However, clinically, this technique lacks randomized, controlled and     double blind studies. Therefore, the investigators have to evaluate the effects of Neural     Mobilization technique in patients with lomboisquiatalgia. In this study the investigators     will treat patients three times a week, with ten minute treatment time per session, with 25     oscillations per minute for ten sessions. Many tools will be used to assess the effects of     the protocol applied, for example: evaluation sheet, visual analogue scale (VAS), quality of     life assessment - WHOQOL-bref questionnaire of Roland Morris disability, oswestry index on     disability (version 2.0), enzyme-linked immunosorbent assays for the measurement of cytokines     in the blood tissue. In this way, the investigators can contribute and understand the     mechanisms involved in the rehabilitation process.   "
46925|NCT02671396|"     The present study is to examine the effects of a virtual reality based balance training using     the Kinect sensor on postural stability and functional balance in individuals with     Parkinson's disease.   "
46926|NCT02671383|"     This is a switch study to assess the non-inferiority (in terms of efficacy and safety) of     darunavir (boosted with ritonavir, DRV/r 400mg/100mg daily) when compared with lopinavir     (boosted with ritonavir, LPV/r total dose 800mg/200mg daily), in combination with a     nucleoside backbone, administered as a second line therapy in HIV positive individuals.   "
46927|NCT02671370|"     This study there are any associations between objective and subjective outcome measures,     measuring the cervical range of motion and if the restriction matter to the patient.   "
46928|NCT02671357|"     This prospective observational study aims to improve the postoperative course after minimally     invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for     pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced recovery     after surgery (ERAS) program.   "
46929|NCT02671344|"     Microarray experiments to assess the expression of thousands of genes providing vast amount     of information.      Because the molecular requirements in the different processes related to playback,on the     hypothesis that there may be more apt semen samples for technical or other assuming molecular     differences in RNA content messengers or gene expression profile between the They getting     semen samples in gestation versus those who do not.      In an attempt to give a functional data obtained view, it is to find out how many of these     genes in donors who have obtained gestation, they are differentially expressed in playback     related processes against those donors who did not get pregnant.   "
46965|NCT02670876|"     The investigators recruited school bullying perpetrators from the age of 12 to 17 by referral     from the local police department. An anti-bullying intervention based on cognitive-behavioral     therapy (CBT) principles was conducted, and addressed issues related to impulse control,     empathy and communication enhancement. All participants completed brain magnetic resonance     imaging, neurocognitive tests, and questionnaires before and after the intervention.   "
46966|NCT02670863|"     The purpose of this study is to evaluate the safety and efficacy of the experimental formula     supplemented with a prebiotic vs the control formula.   "
47004|NCT02670369|"     The investigators are doing a study to learn how to support patients aged 60+ in taking more     breaks from sitting. The goal of the study is to find out if using commercially available     devices are helpful in reducing sitting time.   "
46930|NCT02671331|"     The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with     duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an     accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric     Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS     procedure is safer and easier to perform as it only requires one anastomosis compared to the     BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic     comorbidities, including type-2 diabetes mellitus. However, the initial publications of the     loop DS still resulted in a small number of patients with total protein malnutrition. For     this reason, the investigators will study the loop DS with a modification of the originally     published technique with a longer common channel limb (300 cm) to reduce the risk of protein     malnutrition For patients with a BMI >50, many are limited to just a sleeve gastrectomy as     other bariatric procedures are technically challenging with increased operative risk. A loop     duodenal switch may be a safer operation with improved weight loss for the super-morbidly     obese patient.   "
46931|NCT02671318|"     Cytomegalovirus is the most important opportunistic infection after kidney transplant, with     increased in mortality, morbidity and higher costs of transplantation. Despite the favorable     efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus,     mycophenolate and prednisone, or the investigators local common regimen, tacrolimus,     azathioprine and prednisone, this combinations are associated with higher incidence of     cytomegalovirus infection, disease and recurrence.      Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease,     and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to     decrease the cytomegalovirus infection recurrence.      Given this, the investigators propose a study of their own initiative that attends local     needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus     recurrence after kidney transplant.   "
46970|NCT02670811|"     The objective of the present work was to evaluate the antihypertensive effect associated with     the consumption of fermented milk with Lactococcus lactis NRRL-B50571 on prehypertensive     subjects.   "
47083|NCT02669342|"     The aim of this study is to determine if the Sharklet catheter, with its unique coating,     reduces infections in participants, when compared to a standard catheter.   "
47084|NCT02669329|"     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized     surface applicator for non-invasive subcutaneous fat reduction in the upper arm.   "
46932|NCT02671305|"     Preterm newborns receiving placental transfusion at birth (a volume of blood coming from the     placenta towards the newborn till the cord is left unclamped) have better neonatal outcomes     (in particular reduction of intraventricular hemorrhage all grade). The placental transfusion     strategies performed in preterm babies at delivery have been delayed cord clamping and cord     milking. Both experimental strategies do not explore the contribution of the start of     breathing on placental transfusion, as performed in a small time frame (30-60 seconds for     delayed clamping and less than 20 sec for cord milking). To assist the newborn bedside near     to the delivering mother, leaving the cord unclamped, would allow to explore the contribution     of breathing,both spontaneously started or assisted by initial steps in stabilization, on     early postnatal adaptation.      The purpose of the present study is to assess the feasibility of a large multicentre trial,     whose primary outcome is the reduction of the composite outcome of severe intraventricular     hemorrhage, chronic lung disease or mortality in babies assisted bedside with placental     circulation intact for 3 minutes.   "
46933|NCT02671292|"     To determine whether reducing loss of control eating (LOC) with Interpersonal     Psychotherapy-Weight Gain (IPT-WG) will be effective for adolescent military-dependents who     report such behavior. The investigators will examine whether IPT-WG influences body weight     gain trajectories and prevents worsening disordered eating, psychosocial problems, and     metabolic functioning among military dependents at heightened risk for adult obesity and     disordered eating. This study will provide key efficacy data for a new promising obesity     prevention program for youth from military families.   "
46934|NCT02671279|"     This is a prospective study of morbidly obese patients that are planned to conduct bariatric     surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior     to the operation and be admitted to hospital for this period. On admission and after     finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance     test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous     adipose tissue.   "
46935|NCT02671266|"     The purpose of the current study is to investigate the effect of an acute administration of     intranasal oxytocin, relative to placebo, on social cognitive impairments among individuals     with body dysmorphic disorder and obsessive-compulsive disorder, compared to healthy     controls.   "
46936|NCT02671253|"     This project focuses on myomectomy patients in reproductive age. The aim is to study both the     molecular characteristics of uterine fibroids and to characterize the clinical effects of     surgical treatment.      Patient series is mainly retrospective and consists of individuals who have undergone     myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the     investigators have started a prospective sample collection starting in October 2015,     collecting samples from myomectomies.      Clinical data sources include medical records, specific questionnaires and a quality of life     -questionnaire filled by patients.   "
46937|NCT02671240|"     Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's     disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid     syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the     drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously     including apathy.      Our goal is to describe the natural history of Behavioral Addiction under the effect of the     evolution of the disease and adapt treatment according to the prior art, through a study of a     larger population of patients than in the few published studies.   "
46938|NCT02671227|"     The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg     sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative     pain in gynecologic laparoscopic surgeries.   "
46939|NCT02671214|"     Identify one or more flat bread mixes that produce a reduction in positive incremental area     under the curve (iAUC) of post-prandial glucose relative to the control product.   "
46940|NCT02671201|"     Emergency ultrasound examinations are increasingly important diagnostic tools in emergency     and critical care medicine. This study wants to analyze different types of education for     undergraduate students. Any method of medical training will be proved theoretical and in     clinical practice.   "
47123|NCT02668809|"     The main goals of this pilot study are to develop a nursing home-customized oral hygiene     protocol, intended to be delivered primarily by dental hygienists and primary care providers,     and to identify potential obstacles and barriers to overcome in designing a subsequent     definitive study on the same topic.   "
46941|NCT02671188|"     Chemokine (C-C motif) ligand 20 (CCL20) is a protein involved in attracting immune cells     including subsets of T cells (for example Th17 cells), B cells, natural killer cells and     dendritic cells to inflamed tissues in conditions such as psoriasis (Ps) and psoriatic     arthritis (PsA). CCL20 acts by binding and activating the chemokine receptor 6 (CCR6) present     on the surface of the inflammatory cells. Levels of CCL20 are increased in inflamed tissues     in psoriasis (Ps) and inflammatory arthritis. GSK3050002 is a humanized Immunoglobulin G     (Ig)G monoclonal antibody, which binds to and neutralizes the action of human CCL20. The     hypothesis is that GSK3050002 will reduce the movement of inflammatory cells into tissues     affected by Ps or PsA, thereby leading to an improvement in disease activity. The primary     objective of this multi-centre, randomized, double-blind (sponsor open), placebo-controlled     trial is to evaluate the safety and tolerability of repeat doses of GSK3050002, and to     understand the mechanism of action (by taking skin and synovial biopsy samples) and potential     for clinical efficacy of GSK3050002 in subjects with PsA. A minimum of 18 subjects and up to     a maximum of 30 subjects will be randomised into the study to either GSK3050002 or placebo in     a 2:1 ratio to ensure that approximately 18 evaluable subjects complete the study. The total     duration of participation in the study will be approximately 21 weeks from screening to last     study visit.   "
46942|NCT02671175|"     This study evaluates the efficacy and safety of 3 months of malaria chemoprevention     post-discharge using dihydroartemisinin piperaquine (DHA-P) in children under 5 years of age     admitted with severe anemia. One half will receive monthly DHA-P and the other half placebo.   "
46943|NCT02671162|"     The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity     of pruritus in patients with end-stage renal disease.   "
47537|NCT02663388|"     The purpose of this study was to evaluate the role of vitamin status and epigenetic     mechanisms on severe obesity related-complications.   "
46945|NCT02671136|"     Diabetes and Periodontitis are both prevalent diseases affecting millions of Americans.     Periodontitis is prevalent among Diabetics. Furthermore, Periodontitis and associated     inflammation can increase insulin resistance in Diabetics and worsens the condition.     Hyperbaric Oxygen Therapy (HBOT) has the potential to improve periodontal treatment outcome     in poorly controlled diabetics. The study will compare periodontal treatment (SRP) outcome     between 2 main diabetic type 2 patient groups receiving medical care treatment: either     Conventional Wound Therapies (CWC) with or without adjunctive Hyperbaric Oxygen Therapy at     LLU Health.      24 poorly controlled diabetic mellitus (DM) type 2 subjects (HbA1c =>7%) with Periodontitis     will be assigned into the study arms HBO therapy and Non HBO therapy, based on their medical     needs.      For all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use     history, BMI, current medication list) and oral health habits will be obtained. Blood samples     for HbA1c determinations, clinical periodontal measurements (plaque index, probing     measurements including pocket depth, attachment levels, gingival index and     bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end     of the study. Subgingival microbial samples will be collected from three randomly selected     sites and analyzed for detection of about 300 of the most prevalent oral bacterial species.     Differences in periodontal clinical outcomes and bacterial profiles will be identified     utilizing ANCOVA (Analysis of Covariance).   "
46946|NCT02671123|"     The purpose of this study is to determine whether co-registration of OCT and angiography     reduce geographic miss defined as stent edge dissection or significant residual stenosis at     stent edge after stent implantation during percutaneous coronary intervention.   "
46947|NCT02671110|"     This study compared the recently developed Transforming Your Life (TYL) weight loss program     to the Diabetes Prevention Program (DPP), considered the Gold Standard in behavioral weight     loss treatment.   "
46948|NCT02671097|"     Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin     pharmacokinetics.      PK of BAY1841788 (ODM-201) after single and repeated administration in male and female     subjects.   "
46949|NCT02671084|"     Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can     represents a problem to the patients resulting in increase of morbidity and mortality.      Patients submitted of coronary angioplasty procedures can release in varying degrees of     creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty.      Possibly patients who will receive sevoflurane experience a higher level of cardiac cell     protection with lower incidence in the release of CK - MB values in excess of 100% baseline.   "
46950|NCT02671071|"     The primary objective of this study is to describe the socio-demographic, clinical     pathological, quality of life and treatment characteristics of patients diagnosed with CC in     Brazil.   "
46951|NCT02671058|"     This study will be an open label, single dose, randomized, 2 way (2 period) crossover study     in healthy adult subjects at a single study center.   "
46952|NCT02671045|"     Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional     cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver     mutations, which when targeted with specific therapies, experience improved outcomes.      Unfortunately, identification of these mutations, although recommended in national     guidelines, has been limited for a variety of factors including small biopsy samples. The     broad application of a sensitive genomic profiling test, which simultaneously examines for     multiple genomic alterations on limited biopsy material, could increase the identification of     patients with actionable mutations and thereby improve survival in NSCLC. The FoundationOne     test meets these requirements. A recent study using the FoundationOne assay identified a     significant number of actionable mutations among NSCLC patients who were previously thought     to be negative for mutations when tested using other approaches.      This is a non-randomized observational comparative study with various cohorts based on     physician diagnostic patterns of care and biologic genomic profile status. Survival and cost     information will be compared based on different use of genomic profiling.   "
46953|NCT02671032|"     The purpose of the feasibility study is to examine audiological outcomes (audiometry and     speech perception) and safety (adverse events and adverse device effects) with the Nucleus     CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for     cochlear implantation.   "
46954|NCT02671019|"     The purpose of this trial is to compare the effectiveness and costs of a five-module     Internet-based treatment program (including therapist support) for harmful alcohol use with     the effectiveness and cost of the same treatment content delivered face-to-face in     specialized addiction treatment. The hypotheses to be tested through this trial are that:        1. The Internet-based treatment program (including therapist support) is as effective          (reducing alcohol consumption) as the same treatment content delivered face-to-face in          specialized addiction treatment.        2. The Internet-based treatment program (including therapist support) is associated with          lower cost per treated individual in relation to the achieved effects (in terms of          reduced alcohol consumption) compared with the same treatment content delivered          face-to-face in specialized addiction treatment.      The design is a two-armed randomized controlled trial, and outcomes are measured in terms of     changes in alcohol consumption, problematic alcohol use as well as alcohol dependence,     depression, anxiety, quality of life and costs for the treatments. A minimum of 350     participants will be recruited and randomized into two groups:      Intervention group 1: All participants in this group will have access to the five-module     Internet-based treatment program for harmful alcohol use and have access to a therapist with     training in psychotherapy (CBT) who assists and counsels the participant throughout the     program.      Intervention group 2: All participants in this group will attend five face-to-face treatment     sessions in specialized addiction treatment.   "
47005|NCT02670356|"     Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in     fish oil and in krill oil. The purpose of this study is to compare the effects of the     recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg     - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300     mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and     inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.   "
48199|NCT02654730|"     The purpose of this study is to evaluate the tolerability and safety of increasing doses of     primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males.   "
46955|NCT02671006|"     A biological tool for quantitative assessment of Chronic Urticaria (CU) is still in need for     monitoring biotherapies. CU is considered as a sudden degranulation of Mast cells / basophils     without any identified cause. It is considered that Mast cell/basophil have an abnormally     high sensitivity in CU and can be triggered with almost nothing (high irritability). In     allergy, basophils degranulation can be reproduced in vitro with allergens. Anti-IgE     (immunoglobulin E) antibody mimics allergen triggering of basophils in a dose dependent     manner. If basophils are abnormally sensitive in CU, it should be reproduced in vitro at very     low stimulation. The main objective of this project is to set up a method to evidence     abnormal basophil irritability and look for clinical significance. As many markers     characterize basophils in different states, researchers shall also look for a profile     possibly associated with CU basophile irritability. Such tests could be useful in CU     monitoring.   "
46956|NCT02670993|"     Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns     essentially 65 years old and older patients. Antalgic and psychotropic treatments have     adverse effects in old people, and have to be used carefully. To improve the pain support and     limit the drug consumption, it is possible to perform therapies without drugs. Among them,     musical intervention represents an interesting complementary support, to deal with physical     and moral pain in AD.   "
46957|NCT02670980|"     This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System     (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or     Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo     ophthalmological examinations in predefined intervals after implantation. Ophthalmological     examinations include funduscopy, slit lamp examination and OCT. All adverse events are     recorded and analyzed. Efficacy is measured using functional vision and visual function tests     before and after implantation as well as with the system on and system off.   "
46958|NCT02670967|"     The present study conducted a meta-analysis of 22 randomly controlled trials to assess the     effects of soluble fiber intake on blood pressure in human subjects.      Using the Cochrane Handbook for Systematic Reviews of Intervention, a systematic review and     meta-analysis was conducted. Information regarding study methods, characteristics, mean BP     and standard deviations were extracted The data from each study were pooled using a random     effects model to estimate the effects of soluble fiber consumption on blood pressure.   "
46959|NCT02670954|"     To evaluate the efficacy and safety of appropriate postoperative sedation with     dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled     study was conducted among patients after abdominal surgeries began in October 2015.The     investigators enroll patients who received abdominal surgeries. One group receive sedative     along with analgesic and the other group analgesic only for the other group on the first 24     hours after surgeries and will follow up for 3 days.   "
46960|NCT02670941|"     The rationale behind the proposed study is to determine the initial effectiveness of     aromatherapy in relief of commonly reported symptoms in cancer patients undergoing     chemotherapy.   "
46961|NCT02670928|"     This study aims achieving of long-term weight loss in T2DM patients by use of comprehensive     lifestyle changes program, providing patients with structured diet, exercise plan, group     behavioral support and group education. Additionally the study is designed to establish     reduction of the body weight leads to the improvement of glycemic and lipid metabolism, and     can also reduce blood pressure level. The study is also directed to show that lifestyle     changes program in T2DM patients can lead to decreasing of hospitalization rate and     healthcare consumption. In order to demonstrate a change from standard of care, data will be     collected from a parallel cohort from the same centers.   "
46963|NCT02670902|"     This research uses a multi-phase approach to adapt and implement an established intervention,     Critical Time Intervention, for a new population and setting among individuals with     co-occurring substance use and mental health problems who are at risk of relapse following     residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify     challenges and strategies of community reentry among individuals with co-occurring problems     in residential substance abuse treatment and their providers and social support networks     (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals with     co-occurring disorders in residential substance abuse treatment to prepare them for discharge     and transition back into the community; and (PHASE 3) conduct a pilot study to examine the     feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced     usual discharge planning services.   "
46964|NCT02670889|"     The purpose of this study is to determine if acetohydroxamic acid (AHA) can prevent     hydrolysis of urea by inhibiting the bacterial urease of gut flora of both healthy control     adults as well as adults with urea cycle disorders.   "
46967|NCT02670850|"     Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more     severe than can be explained by an individual's age and education. One study in the United     States found that MCI caregivers have experienced distress in association with caregiver     burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%.     Understanding the process of family caregiving provides a knowledge base for the health     professionals when developing effective interventions. However, little is known about the     phenomenon of family caregiving to patients with MCI in Taiwan.      Therefore, the purpose of the proposed study is to develop a theoretical model and a     model-based intervention program for family caregivers of patients with MCI in Taiwan, and     pilot test it in a clinical trial.   "
46968|NCT02670837|"     Few but persistent wounds often remain even after successful hematopoietic cell     transplantation for systemic genodermatosis epidermolysis bullosa (EB). The investigators     propose local wound therapy using epidermal skin grafting from the same donor that provided     the hematopoietic graft, or from the same EB individual with a mosaic (naturally gene     corrected) skin. In both cases permissive immune system and skin chimerism is expected to     enable long-term epidermal engraftment and wound healing. The investigators will use FDA     approved vacuum device (CelluTome®, Regulation number 878.4820) that enables painless,     bloodless and scar-free harvesting of epidermis and its transfer on a square of surgical tape     (Tegaderm®) to the recipient as a wound dressing.   "
46969|NCT02670824|"     This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single     escalating dose and repeated doses of CN-105 in healthy adult participants. There will be     about 48 subjects, 36 active and 12 placebo.   "
46971|NCT02670798|"     The long-term goal of this study is to optimize the perioperative care of pediatric spinal     deformity patients, minimizing perioperative complications and increasing cost-effectiveness     of perioperative hematologic management. The objective of the proposed study, which is the     initial step in pursuit of this goal, is to evaluate the effectiveness of thromboelastography     (TEG) to monitor coagulation pathways and direct blood product replacement in pediatric     neuromuscular spinal deformity surgery. The central hypothesis of this study is that TEG will     decrease exposure to allogeneic packed red blood cells (PRBC). The rationale is that proven     effectiveness of TEG in neuromuscular deformity may change the standard of care for     hematologic management in neuromuscular spinal deformity cases and additionally set the stage     for a multicenter trial in idiopathic pediatric deformity.   "
46972|NCT02670785|"     This study will access the safety and efficacy of three doses of estradiol vaginal capsules     in postmenopausal women with vulvovaginal atrophy.   "
46973|NCT02670772|"     The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior     (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV     treatment.   "
46974|NCT02670759|"     This study is designed to assess:        -  The impact of continuous thoracic paravertebral nerve blockade compared to intercostal          nerve blockade on the intensity of postoperative pain following VATS in subjects having          a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.        -  The impact of continuous thoracic paravertebral analgesia on length of stay, opioid          intake, respiratory function, incidence of side-effects and postoperative complications.      The basic hypothesis of this study is that continuous thoracic paravertebral nerve blockade     will provide superior postoperative analgesia following VATS when compared to intercostal     nerve blockade in patients having a PCA device as their primary analgesic modality. Superior     quality of analgesia should contribute to preserve pulmonary function, reduce opioid intake     and related side-effects and shorten the hospital stay.   "
46975|NCT02670746|"     The objective of the study is to prospectively assess the use and treatment outcomes of     nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands.     Additional objectives are to monitor the incidence and reversibility of neuropathy during     treatment, to assess the patient's Quality of life when treated with     nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating     metastatic pancreatic cancer.   "
46976|NCT02670733|"     There are concerns that the use of positive end-expiratory pressure (PEEP) for the treatment     of pulmonary complications in patients with brain injury may potentially elevate intracranial     pressure (ICP), and deteriorate neurological status. It is suggested that both respiratory     system compliance and ventricular compliance would contribute to the elevation of ICP when     PEEP increases. In theory, PEEP may cause elevation of ICP by increasing intrathoracic     pressure and diminish venous return. However, the transmission of PEEP into thoracic cavity     depends on the properties of the lung and chest wall. Experimental study showed that when     chest wall compliance is low, PEEP can significantly increases intrathoracic pressure;     whereas low lung compliance can minimize airway pressure transmission. It is generally     recognized that the lung compliance decreases in acute respiratory distress syndrome (ARDS)     patients due to extensive alveolar collapse. However, it has been report that the elastance     ratio (the ratio between elastance of the chest wall and the respiratory system, where     elastance is the reciprocal of compliance) may vary from 0.2 to 0.8. Therefore, it is     important to distinguish the compliance of the chest wall and the lung when investigating the     effect of PEEP on ICP.      Because intrathoracic pressure (pleural pressure) is difficult to measure in clinical     situations, esophageal pressure (Pes) is considered as a surrogate of intrathoracic pressure.     In the present study, the investigators determine the effect of PEEP on intrathoracic     pressure and ICP by Pes measurement.   "
46977|NCT02670720|"     This is an open-label study designed to evaluate the long-term safety of prophylactic     avoralstat (500 mg three times daily) when given to approximately 150 patients with     hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate     the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.   "
47019|NCT02670174|"     A randomized controlled trial will be conducted to examine the effectiveness of a traditional     home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of     overhead athletes with shoulder impingement syndrome. Primary outcome measures are reduction     of pain and disability, and improvement in functionality and sports performance. Secondary     outcome measures are strength, mobility, flexibility and functional performance.   "
46978|NCT02670707|"     Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause     lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a     cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes     there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF     gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells     to build up in certain parts of the body, where they can damage tissue or form lesions.      For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line     therapy while cytarabine therapy has been used as therapy for patients who develop     recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.      The purpose of this research study is to compare previously used vinblastine/prednisone to     single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study     called a positron emission tomography (PET) scan to more accurately assess areas of LCH     involvement not otherwise seen in other imaging studies as well as response to therapy. We     also want to identify if genetic and other biomarkers (special proteins in patient's blood     and in patient's cancer) relate to the response of patients LCH to study treatment.   "
47006|NCT02670343|"     An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a     single study site. Each study participant received a single oral TU dose immediately prior to     a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of     fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and     post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.   "
47007|NCT02670330|"     The aim is to assess the long-term safety of topical use of ZORBLISA in patients with     Epidemolysis Bullosa.   "
46979|NCT02670694|"     This study will investigate sleep behavior in subjects with Angelman Syndrome, Rett Syndrome     or Prader-Willi Syndrome.      The study will also investigate sleep behavior in healthy siblings of subjects with Angelman     Syndrome, Rett Syndrome or Prader-Willi Syndrome. These individuals will serve as control     subjects.      The study will use questionnaires designed to identify sleep disorders and how they affect     behavior and quality of life.      The principal goals of this study are:        1. To see how common sleep disorders are in individuals with Angelman Syndrome, Rett          Syndrome or Prader-Willi Syndrome;        2. To see how sleep disorders affect behavior in these individuals;        3. To see whether sleep disorders and related behavior problems improve or worsen with age;        4. To see how specific disease conditions relate to sleep disorders and how bad the sleep          disorders are;        5. To develop new treatment options to improve quality of life and behavior issues; and        6. To evaluate current treatment options to improve sleep problems in these individuals.   "
46980|NCT02670681|"     The aim of this intervention study is to evaluate the acute and chronic effects of different     intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of     subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40 to     70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in     acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and     session control. After, the subjects will be randomly allocated into four intervention     groups: mild intensity group, moderate intensity group, high intensity group and control     group. In both phases, the subjects have blood pressure data recorded by ambulatory blood     pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be     registered biological signs of blood pressure (finometer), electrocardiogram (DII derivation)     and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic     modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and     peripheral vascular resistance.   "
46981|NCT02670668|"     The study is to determine the prevalence of potential chemo-response related genes mutation     in TNBC patients between pCR and SD/PD group, which achieved after NAC; and to evaluate     potential relationship between these gene mutations and NAC-response in TNBC patients.Based     on the results,we can further characterize TNBC from a phenotypical and molecular     perspective, in order to identify potential new target agents and to individualize the     treatment.   "
46982|NCT02670655|"     Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic     species across membranes and may have significant benefit for the treatment of actinic     keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT).   "
46983|NCT02670642|"     The purpose of this study is to compare on demand with continuous treatment of endoscopy     negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once     daily, with regards to willingness to continue in the study as a result of satisfactory     treatment over a six-month long term management period, after initial symptom relief.   "
46984|NCT02670629|"     This fractures have been managed with anatomical reduction performed under anesthesia or     using sedatives. In our institution this means prolonged hospital stay, involvement of an     anesthesiologist and the use of an special room in the Emergency Department. This research     protocol was born after reports were published regarding leaving the fractures in an     overriding position and cast with good functional and acceptable radiographical results; said     study was observational, providing valuable but limited information about this treatment     option. On the other hand, our study is a randomized controlled trial between to groups of     patients younger than 11 years old who presented to the Emergency Department with completely     displaced distal radius fractures, they were randomly assigned to one of two groups, either a     closed anatomic reduction and short cast or a closed overriding alignment and short cast.   "
46995|NCT02670486|"     Many women have the need to run to the restroom frequently during the night and day, a     condition called overactive bladder. Embarrassing urinary leakage is also commonly     associated with these symptoms. The investigators believe the primary cause in most cases is     the bladder muscle contracting too frequently but are still not sure exactly why this happens     and if it is triggered by factors in the environment. When bladder testing using pressure     catheters (urodynamics) is done these bladder contractions are often not picked up, even in     women with overactive bladder. This may be partly due to the unnatural environment in which     the testing is done without the presence of the usual visual or audible triggers, such as     running water or seeing a toilet. The investigators propose adding an audiovisual stimulant     to the usual bladder testing to see if this makes it more likely for bladder contractions to     happen. One group of patients would have the usual bladder testing as part of their normal     care. The other group would receive the normal care in addition to hearing a water fountain     in the room and watching a video of things that may trigger overactive bladder symptoms;     seeing public restroom signs in a mall, a toilet bowl being lowered and a kitchen sink with     water running over dishes. The suspicion is that the proportion of patients in whom bladder     contractions are seen will be higher for those with audiovisual triggers compared to those     with the usual care. Women with overactive bladder or leakage with urge who are sent for     urodynamics by their doctor will be asked if they wish to participate in the study.   "
47008|NCT02670317|"     This is a prospective, multicenter, single arm, phase II trial in young patients (18-60     years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma     (DLBCL).      Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with     ibrutinib.   "
47009|NCT02670304|"     Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in     luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one     candidate for the treatment or prevention of ovarian hyperstimulation syndrome.   "
47010|NCT02670291|"     This randomized, sham-controlled, double blind, multicentre clinical trial aims at providing     evidence for the efficacy and safety of continuous theta burst stimulation (cTBS) in the     treatment of auditory hallucinations in patients with schizophrenia. Overall, the study will     include 86 patients. Each patient will receive a three weeks course of daily (5/week)     treatment; 50% of the patients will be treated with cTBS (1200 impulses daily), the other     half with a sham stimulation to the left and right temporoparietal cortex. Sham stimulation     will be applied by an active sham-coil that allows for a double-blind treatment. Follow-up     assessments 1, 3 and 6 months after treatment will investigate the stability of treatment     effects.   "
46985|NCT02670616|"     EBV-positive diffuse large B-cell lymphoma has EBV-mediated oncogenic signaling pathway     activation, and these multiple intracellular pathway can be potential therapeutic target in     this disorder. Thus, EBV-associated protein, LMP1 can induce the activation of various     downstream pathway molecules such as PI3K/Akt and NF-kB activation. The activation of NF-kB     is one of essential factors contributing to prolonged survival and aggressive phenotype of     diffuse large B-cell lymphoma. In a more aggressive subtype of diffuse large B-cell lymphoma,     activated B-cell like type, chronic active B-cell receptor signaling and MYD88 mutation are     known to stimulate NF-kB transcription and activation. As a result, a key molecule mediating     B-cell receptor signaling pathway, Bruton tyrosine kinase (BTK) can have a critical role, and     BTK has been emerging as a therapeutic target in diffuse large B-cell lymphoma. Considering     the close association between B-cell receptor signaling pathway and PI3K/Akt pathway in     diffuse large B-cell lymphoma, targeting BTK might be helpful for improving treatment outcome     of EBV-positive diffuse large B-cell lymphoma.      Ibrutinib, BTK inhibitor has an activity against B-cell non-Hodgkin lymphoma via targeting on     B-cell receptor signaling pathway. As a result, the evidence of antitumor- effect of     Ibrutinib has been accumulated in several types of B-cell lymphoma such as mantle cell     lymphoma. Given EBV-positive diffuse large B-cell lymphoma is known as having poor response     to treatment compared to diffuse large B-cell lymphoma, not otherwise specified (NOS), the     addition of ibrutinib to standard chemotherapy regimen, rituximab-CHOP may provide benefit     these patients.   "
46986|NCT02670603|"     This study is a prospective randomized controlled study of EVONAIL® solution for prevention     or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.   "
46987|NCT02670590|"     Investigators perform a counseling intervention study (6 months) in adult subjects with     evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS);     exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90     ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus     hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model     assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual healthy food     purchase, storage, and cooking were given. Reliable feedback and evidence of patients'     adherence were obtained by scheduled dietician's interviews. Investigators will challenge the     predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score     and of increased physical activity at 6 months in a body mass index changes-balanced model to     detect independent effects, if any, of the studied variable on NAFLD persistence,     amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary     profile score will be calculated by contingency tables and receiver operator characteristic     curve (ROC) analysis..   "
46988|NCT02670577|"     The scope of this study is to measure the impact of MammaPrint on treatment in Hormone     Receptor (HR)-positive HER2-negative breast cancer patients.      In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up     to 1 node), Triple Negative or HER2-positive tumors will be assessed.   "
46989|NCT02670564|"     Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient     genetic variations which influence activity of enzyme metabolizing or acting in the pathway     of prescribed chemotherapy drugs.      This add-on research aims to prospectively investigate variations in several candidate genes     related to all types of chemotherapeutic drugs and TBI used in the main related study NCT     01949129, THE ALL SCTped FORUM study for their potential role as predictive biomarkers of PK     variability and outcome of myeloablative therapy for pediatric patients receiving an     allogeneic hematopoietic stem cell transplantation in acute lymphoblastic leukemia.   "
46990|NCT02670551|"     This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 mg/day or 3     mg/day compared to placebo for treatment of the depressive episode in patients with bipolar I     disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.   "
46991|NCT02670538|"     This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of     cariprazine 1.5 mg/day or 3 mg/day compared to placebo for treatment of the depressive     episode in patients with bipolar I disorder. The safety and tolerability of the fixed-dose     regimens will be evaluated.   "
46992|NCT02670525|"     This research study is seeking to gain new knowledge about Recurrent, Refractory, or High     Risk Leukemias in children and young adults.      This study is evaluating the use of specialized testing called leukemia profiling. Once the     profiling is performed, the results are evaluated by an expert panel of physicians,     scientists and pharmacists. This may result in a recommendation for a specific cancer therapy     or a clinical trial called matched targeted therapy (MTT). The results of the leukemia     profiling and, if applicable, the MTT recommendation will be communicated to the     participant's primary oncologist.   "
46993|NCT02670512|"     Compared to hemodialysis, patients on peritoneal dialysis live longer and healthier, have a     higher quality of life and cost approximately $40,000 less to the healthcare system per     patient per year. However, only 18% of dialysis patients in Canada currently use peritoneal     dialysis because patients often feel isolated from the healthcare team and lack the     confidence to manage treatments by themselves. This study will assess a telehome monitoring     system (eQ Connect™), allowing for up-to-date data transmission and digital interaction     between the patients at home and their healthcare team. From the patients' perspective, this     technology is an easier way to communicate with their healthcare providers, track their     treatment and supplies, and receive training and support. From the providers' perspective, eQ     Connect™ delivers up-to-date patient data and provides an efficient way to keep track of the     patients' progress. This intervention has the potential to improve the patients' clinical     outcomes, quality of life, reduce the costs of dialysis to the healthcare system and     ultimately empower patients to start and stay on peritoneal dialysis.   "
46994|NCT02670499|"     Post Market TKR study   "
46996|NCT02670473|"     The aim of this dispensing study is to evaluate the clinical performance of habitual wearers     of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.   "
46997|NCT02670460|"     Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter,     confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony     with mechanical ventilator breaths.   "
47011|NCT02670278|"     It is well-known that breastfeeding protects infants from illness, especially in the poorest     regions of the world. The full nature of this protective effect, however, is less well     understood. A major barrier to understanding is the fact that almost nothing is known about     the factors that influence the considerable variation in milk composition around the globe,     or about the effects of this variation on infant health. This INSPIRE project represents the     first comprehensive investigation of the global differences in human milk composition along     with the various microbial, evolutionary, environmental, and sociocultural factors that might     influence both milk composition and infant health. An international, interdisciplinary     collaboration of physiologists, nutritional scientists, anthropologists, microbiologists, and     mathematicians will collect biological data from breastfeeding women and their infants, in     concert with extensive anthropologic and ecological data, in both developed (US, Spain,     Sweden) and developing countries (Central African Republic, Gambia, Ghana, Peru, and Kenya).     To test the possibility of a correlation between milk oligosaccharide composition, milk     microbiota, and the gastrointestinal microbiome of infants, milk samples and infant fecal     samples will be analyzed using state-of-the-art biochemical and genomic techniques. This     study will allow important cross-cultural comparisons of milk composition and infant feeding     practices; it also will utilize sophisticated computational methods to integrate the     extensive, diverse body of combined biological and anthropological data to elucidate the     relationships among sociocultural factors, evolutionary history, environmental exposures,     microbial constituents and milk composition. The researchers predict that what is considered     normal milk composition in one population may not support optimal health in another. This     information is crucial to the humanitarian quest to understand how infant nutrition and     overall health can be improved around the world. In addition, this project will provide     extensive research training opportunities for undergraduate, graduate and postdoctoral     scientists.   "
47012|NCT02670265|"     Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many     procedures for diagnostic workup that require fasting periods. In a prospective randomized     monocentric study we evaluate the effect of additional parenteral nutrition on weight loss,     nutritional status, quality of life and length of hospital stay.   "
47013|NCT02670252|"     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient     tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice     between BU-based or TBI-based conditioning regimens still remains controversial. In this     study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in     patients undergoing allo-HSCT for ALL in CR1 are evaluated.   "
47014|NCT02670239|"     Ex vivo lung perfusion (EVLP) is an established strategy to evaluate and optimize high-risk     donor lungs that would otherwise be rejected for transplantation mainly due to the presence     of edema or infection. Extracorporeal circuits may negatively affects pharmacokinetic (PK) of     several drugs including antibiotics, thus exposing patients to risk of therapeutic failure or     drug toxicity. The investigators set out to examine the concentration of imipenem in lung     perfusate and in lung biopsy during EVLP, and its clinical impact.   "
47015|NCT02670226|"     The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to     diagnosis. The second objective is to better understand the pathogenesis of this disease by     the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.   "
47016|NCT02670213|"     This study is conducted in Asia. Tha aim of this study is to investigate Safety and     Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in     Japan.   "
47017|NCT02670200|"     Cancer patients develop a high psychological burden of the underlying disease. To support     patients in outpatient phases psychotherapists are not sufficiently available for establish     regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support     can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet     (called Incobeth®) in cancer patients.   "
47018|NCT02670187|"     The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute     respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe     pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600     individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that     expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of     GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed     by electroporation. The study will also assess immune responses over a 1 year period with     respect to the generation of antibody and cellular responses.   "
47020|NCT02670161|"     The investigators will conduct at NorthShore University HealthSystem pragmatic trials using     the EMR for 10 common neurological disorders. They will demonstrate the feasibility of     subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data     capture at the point of care using the EMR. They will identify the most effective treatments     for common neurological disorders and seek replication by the NPBRN.   "
47021|NCT02670148|"     This study is a randomized controlled trial designed to compare the effects of 4 weeks of     chiropractic care to a waitlist control group on measures of strength, balance, and endurance     in military personnel experiencing non-surgical low back pain.   "
47022|NCT02670135|"     This is a single center, double blinded, randomized, controlled trial. Qualified subjects     will be enrolled and randomized to either one of the two study groups: a) using 0.3%     triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice     (copolymer/fluoride/no triclosan) twice daily.   "
47023|NCT02670122|"     This is an observational, multicenter, single arm, prospective study to evaluate safety and     tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial     chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to     150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).      The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads     with larger volumes without increasing the risk and complications of DEB-TACE.   "
47024|NCT02670109|"     Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express     estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Its incidence is     approximately 180,000 cases per year. TNBC are known to be more aggressive with poor     prognosis specially when no pathologic complete response (pCR) is achieved after neoadjuvant     chemotherapy, with a higher risk of recurrence and a poor survival once that recurrence     occurs. On the other hand, there is not a specific adjuvant or neoadjuvant treatment for     these patients. Since autologous hematopoietic stem cell transplantation (HSCT) allows the     usage of higher doses of chemotherapy, which results in higher cellular destruction with a     decrease of hematological toxicity, it is proposed that this procedure is able to improve     prognosis in TNBC patients with no pathologic complete response after neoadjuvant     chemotherapy.   "
47025|NCT02670096|"     This is a single center pilot study evaluating the immediate effects of low-dose     acetazolamide on respiratory control in subjects with treatment emergent sleep disordered     breathing. The purpose of this study is to assess the immediate effect one-time low-dose     acetazolamide on sleep breathing in (Treatment Emergent Sleep Disordered Breathing) TE-CSA     subjects compared to subjects' baseline evaluation without acetazolamide. Investigators will     also try to determine the immediate effect of one-time low-dose acetazolamide on subjects'     resting ventilation and ventilatory response slope compared to subjects' baseline evaluation     without acetazolamide.   "
47026|NCT02670083|"     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the     efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.     Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab     or placebo every 4 weeks (q4w) for 100 weeks. The final efficacy and safety assessment will     be performed 52 weeks after the last crenezumab dose.   "
47027|NCT02670070|"     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of     gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in     healthy male volunteers.   "
47028|NCT02670057|"     The purpose of this open label pilot study is to evaluate the utility of sphenopalatine     ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.   "
47029|NCT02670044|"     The primary objective for this study is to assess the safety and tolerability as well as     preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in     combination with idasanutlin in patients >/= 60 years of age with relapsed or refractory     acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.   "
47030|NCT02670031|"     Hypertension and aortic stenosis are the two leading conditions that cause thickening of the     heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially     adaptive to maintain optimal heart function. Ultimately, heart failure occurs as a result of     progressive muscle cell death and scarring (myocardial fibrosis). Dedicated techniques using     cardiovascular magnetic resonance imaging (MRI) and novel high-sensitivity cardiac troponin     blood assays are potential markers to detect myocardial fibrosis. Although     hypertension-related heart disease is very common in Singapore, the significance of     myocardial fibrosis is not well understood. In this study, the significance of myocardial     fibrosis in 500 patients with hypertension would be investigated. This will be the largest     study using state-of-the-art MRI to examine the importance of myocardial fibrosis in     hypertensive heart disease.   "
47031|NCT02670018|"     A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the     Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl     Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component     Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets)     Administered in Healthy Male Volunteers.   "
47032|NCT02670005|"     To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI)     assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous     coronary intervention (PCI).   "
47033|NCT02669992|"     There are severel problems associated with the closing of a temporary loop-ileostomy after     surgery for rectal cancer. The purpose of this study is to answer two questions:        1. The choice of anastomotic method - does it influence the postoperative course?        2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?   "
47045|NCT02669836|"     The purpose of this study is to determine whether a posterior fossa decompression or a     posterior fossa decompression with duraplasty results in better patient outcomes with fewer     complications and improved quality of life in those who have Chiari malformation type I and     syringomyelia.   "
47124|NCT02668796|"     This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the     Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem®     (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to     Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.   "
47034|NCT02669979|"     Today's increase of dentate elderly, many of them dependent, is a challenge, both according     to the personal daily oral hygiene and dentistry. This is not only an oral problem, as     research findings point to strong associations between oral and general health, even     mortality. These findings are especially noticeable in elderly and frail individuals.      Dental care is usually performed in stationary dental clinics where the patients are     transported to receive treatment. Dependent elderly dental patients may present many     obstacles to traditional dental care due to cognitive limitations or dementia, mobility or     transport problems. An alternative is domiciliary dental care where the dental staff performs     the treatment by a home visit, in the patients daily living environment. The ability to     handle personal oral hygiene is often decreased in these patients and left to overburdened     nursing staff that often also lack sufficient knowledge about oral health care, why     prophylactic professional oral care is especially important. This type of care can with     rather simple equipments be performed as domiciliary treatment of good quality, while more     advanced dental care may present restrictions in the home environment. However, in the     Swedish dental system with subsidized dental care for dependent and elderly patients, there     are restrictions for the number of prophylactic oral care treatments. The levels vary in     different counties and regions. The rationale for this is probably tradition and economy as     scientific evidence is lacking.      The aim with this project is to develop domiciliary professional oral care. The researchers     will compare the effect of different regimens for domiciliary prophylactic professional oral     care both according to content and frequency. The overall aim is to establish relevant     recommendations for domiciliary prophylactic professional oral care.   "
47035|NCT02669966|"     It is well recognized that a subset of patients who contracts Hepatitis C virus (HCV)     spontaneously clears the virus. Such individuals are anti-HCV antibody positive, yet HCV RNA     PCR negative in the blood. While they have not been considered candidates for live kidney     donation in the past, with the recent availability of novel anti-HCV drugs with >95% cure     rates, they now represent a potential pool of donor candidates, especially since the risk for     transmission of HCV to the recipient is extremely low. The investigators goal is to     demonstrate that live kidney donation from anti-HCV positive, HCV RNA PCR negative     individuals is safe and carries a negligible risk of viral transmission to the recipient.   "
47048|NCT02669797|"     This childhood obesity randomized controlled trial uses innovative methods, such as video     feedback and ecological momentary intervention (EMI) to compare a family meals coaching     intervention to a usual care condition in racially/ethnically diverse children ages 5-7 years     and their families. The intervention utilizes in-home visiting methods targeting family meal     quantity and quality delivered across a three-phased incremental 18-month period compared to     obesity prevention messages delivered during well-child visits and monthly newsletters.   "
47036|NCT02669953|"     Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common     disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of     photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in     the disease process.      The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to     the current routine therapy using aflibercept in eyes with treatment naive, recurrent or     persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy.      20 patients with recurrent or persistent nAMD, previously treated with intravitreal     ranibizumab for up to one year will be included in this trial. Patients will be examined in     monthly intervals over 12 months follow-up.      Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts     at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl.     funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence     fundus image (AF) & red-free autofluorescence fundus image (RF), Color fundus photography     (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry     (MP), as well as Non-invasive OCT based optical angiography (AngioVue).   "
47037|NCT02669940|"     This study seeks to assess the effectiveness, patient reported outcomes, work productivity     and healthcare resource utilization of the interferon-free regimen of Paritaprevir     (PTV)/ritonavir (r) - Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C     (CHC) participants in a real life setting across clinical practice populations.   "
47038|NCT02669927|"     To find an objective, affordable and manageable way to measure frailty in elderly patients     and to examine relationship between peri-operative metabolism of frail older people and     outcome after hip surgery.   "
47039|NCT02669914|"     Brain metastases are the most common intracranial malignancy occurring in 20-40% of all     cancers, and the presence of CNS metastases is associated with a poor prognosis. As such, the     median overall survival of patients with symptomatic brain lesions is a dismal 2-3 months     regardless of tumor type. Because standard chemotherapy largely does not cross the blood     brain barrier at a meaningful concentration, standard treatment is limited and usually     involves surgical resection and/or stereotactic radiosurgery for isolated lesions and whole     brain radiation for multiple lesions. Unfortunately, the median overall survival is only     improved by about 6 months with this multimodality approach2, and there is a paucity of     second-line therapies to treat recurrence. Furthermore, re-resection and re-radiation are     often not feasible options due to concern for increasing complications or neurotoxicity,     respectively. Thus, there is a dire clinical need for additional treatment options for this     patient population.      Checkpoint blockade therapy, in particular PD-1 and PD-L1 inhibition, has recently shown     clinical efficacy in multiple types of solid tumors. The investigators propose to study the     efficacy of checkpoint blockade therapy in patients with solid tumors and     refractory/recurrent brain metastases. The investigators will assess the efficacy of     MEDI4736, a novel PD-L1 inhibitory monoclonal antibody, in this study.   "
47040|NCT02669901|"     The purpose of this pilot-study is to to distribute naloxone auto-injector in a Universal     Precaution manner to patients with opioid substance use disorder. The objectives are to     decrease the number of fatal and nonfatal overdose deaths, to examine and understand the risk     factors for serious opioid toxicity and overdose, and to evaluate the unintentional opioid     overdose risk utilizing an evidence-based screening questionnaire.   "
47041|NCT02669888|"     Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in     children. The aims of this project are:        1. To evaluate the efficacy of indigo naturalis ointment in treating AD topically;        2. To evaluate the safety of indigo naturalis ointment in treating AD topically;        3. To investigate whether indigo naturalis ointment treatment is associated with a change          in total IgE, cytokines, eosinophils, and CRP in patients with AD;        4. To evaluate whether indigo naturalis ointment treatment improves the quality of life in          patients with AD.   "
47042|NCT02669875|"     Portal hypertension (an increase in blood pressure in the portal vein that carries the blood     from the intestine and spleen to the liver) underlies most of the serious complications of     liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis     evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver     blood flow.   "
47043|NCT02669862|"     This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment     groups.   "
47044|NCT02669849|"     The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with     Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific     evaluation of the effects of VX-210 on neurological recovery and daily function after spinal     cord injury.   "
47046|NCT02669823|"     Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate     clinically. This poses a particular threat in low resource areas, where bBSI is often not     diagnosed due to the unavailability of rapid diagnostic means. Even if used appropriately,     the sensitivity of blood culture to diagnose bBSI is estimated to be around 50%. To counter     the high mortality rate associated with bBSI, antibiotics are often prescribed without     microbiological confirmation. Sysmex Company has developed technology that enables the rapid     diagnosis of malaria using a venous blood sample. In addition algorithms based on     hematological parameters can be used to monitor disease severity and progression, as well as     guide further diagnostic testing based on differences seen in these parameters between     various types of disease. The algorithms have been developed and tested in adult populations     from different industrialized countries and in one Asian population. However no data are     available neither from pediatric patients, nor from the sub-Saharan setting where the     epidemiology of infectious diseases is very different from the tested settings. The objective     of the study is to: 1) Assess the sensitivity and specificity of the Sysmex hematology     analyzer based on the new technology to diagnose malaria in subjects older than 3 months, who     present with an acute severe febrile illness in a malaria endemic area in sub-Saharan Africa     2) Test and optimize the value of Sysmex analyzers in disease diagnosis and monitoring in     children older than 5 years and adults, who present with an acute severe febrile illness in a     malaria endemic region in sub-Saharan Africa, to differentiate between severe malaria and     bBSI, or a combination of these infections. 3) Explore the value of Sysmex analyzers in     disease diagnosis and monitoring in children between 3 months and 5 years of age, who present     with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa.   "
47047|NCT02669810|"     The main purpose of this phase I/IIB is to evaluate the safety, the tolerance and the first     efficacy trends of intracardiac injection of ProtheraCytes (autologous PB-CD34+ Stem Cells     after automated ex-vivo expansion with the StemXpand machine) in patients with a De Novo     acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be reinjected     using a dedicated catheter pushed through the femoral artery up to the left ventricle, thus     avoiding open chest surgery.   "
47056|NCT02669693|"     This research is aimed at determining whether the presence of oleuropein in olives (Olea     europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will     be required to consume commercially available olives together with white bread, and their     glycaemic response will be measured. The blood glucose response of bread will be determined     initially as a control/reference. Food samples and control will be consumed in random order.      The recent rise in the cases of Diabetes mellitus in both children and adults has raised a     concern for the need to proffer immediate solutions amongst scientists in the fields of     medicine food science and nutrition. One of the approaches of reducing postprandial     hyperglycaemia and high glucose spikes is to impede digestion and absorption of starch. This     is potentially achieved through the inhibition of the activities of starch digesting enzymes     namely alpha amylase and alpha glycosidase. There are currently some antidiabetic drugs such     as acarbose and miglitol which have been quite efficient in these inhibitory functions but     not without associated side effects and complications such as liver toxicity, etc, arising     from to long term usage of such drugs. It therefore becomes imperative for natural     substitutes from food sources to be explored as better alternatives. At the moment several     plant foods are under investigation as suitable alternatives, and olives appear to be quite     promising in this regard. There are quite a few studies that have reported the inhibitory     activities of olives oleuropein on alpha amylase in vitro but information on in vivo testing     is very scarce.      It is expected that the research outcome will be a gateway to the reduction and control of     the incidence of diabetes mellitus.   "
47057|NCT02669680|"     Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with     acute on chronic liver failure (ACLF) who meet inclusion/exclusion criteria.The objective of     GRAFT-trial is to evaluate efficacy and safety of subcutaneously administered granulocyte     colony-stimulating factor (G-CSF) in patients with ACLF. All patients will receive standard     medical care for ACLF according to the guidelines. Patients in the experimental arm     additional receive subcutaneous injections of G-CSF.   "
47058|NCT02669667|"     This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to     assess the safety and tolerability of MEDI9314 in healthy adult subjects   "
47111|NCT02668978|"     The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in     reducing the incidence and duration of air leaks after lung resection compared to standard     techniques.      Hypothesis: The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in     lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the     incidence and duration of prolonged air leaks as compared to standard surgical measures.   "
47060|NCT02669641|"     The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in     patients diagnosed with hepatic steatosis in treatment with combination Silimarin,     Phyllanthus Niruri and Choline.   "
47061|NCT02669628|"     The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol     sclerotherapy of endometriomas versus conventional surgery.   "
47062|NCT02669615|"     This study is a single-center, open-label study of high-dose Melphalan HCl for injection     (propylene glycol free Melphalan) conducted in 24 patients, who have symptomatic multiple     myeloma and qualify for ASCT.      There will be three distinct evaluation periods in this trial: a pretreatment period, a study     period and a follow-up period.   "
47063|NCT02669602|"     Dynamic prospective cohort of Spanish university graduates. The main objective is to evaluate     the associations between nutrition and lifestyle and chronic diseases.   "
47064|NCT02669589|"     The aim of this study is to evaluate the effect of regional citrate anticoagulation within     the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney     injury (AKI) on filter life span and 90-day all cause mortality.   "
47065|NCT02669576|"     This randomized controlled trial aims to investigate the effectiveness of a mind body day     care clinic program of breast cancer patients undergoing endocrine therapy.   "
47066|NCT02669563|"     The main goal of this study is to test two new radioactive drugs,     4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG) and     3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) in human subjects with congestive     heart failure.      Evaluations of these imaging agents will include their uptake in heart, lungs and liver,     their metabolic breakdown in blood, and their kinetics in the heart. Based on these studies,     the better of the two drugs will be chosen for further studies in patients with heart     disease. After the better compound is chosen, additional measures of its imaging properties,     metabolism and pharmacokinetics will be done in subjects with heart failure.   "
47067|NCT02669550|"     The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the     management of difficult tracheal intubation, and it is considered as a gold standard. The     disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical     practice recently.This study compares FOB and DE for awake orotracheal intubation in obese     patients with anticipated difficult airway.   "
47068|NCT02669537|"     Utilization of the GoPro camera to facilitate vaginal surgical education among residents and     medical students   "
47085|NCT02669316|"     NAFLD is associated with unhealthy lifestyle and obesity, without alcohol habits. An     association of NAFLD with coronary artery disease and with impaired heart function was     reported, but without considering severity of NAFLD and with the bias of including diabetes.     Aim: to challenge if severity of liver steatosis assessed by UltraSound Bright Liver Score     (BLS) can predict the impairment of systolic heart function, assessed by echocardiography     (Ejection Fraction, EF), diastolic function (assessed by E/A ratio), Left Ventricular Mass,     Left atrial diameter.   "
47086|NCT02669303|"     The purpose of this study is to determine whether injection of platelet-rich plasma derived     from patient's blood is effective in treatment of shoulder subacromial impingement syndrome     as compared to the current protocol of methylprednisolone injection.   "
47087|NCT02669290|"     The purpose of this study is to determine whether multiple gated acquisition (MUGA) guided     lead placement improves clinical outcomes for patients needing cardiac resynchronization     therapy (CRT) compared to traditional posterolateral left ventricular lead placement.   "
48200|NCT02654717|"     The purpose of this study is to see how well DFD-07 works in treating actinic keratosis on     the face and scalp during 8 weeks of treatment. The study will also look at any unwanted     effects of the study drug.   "
47069|NCT02669524|"     In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to the     relative insulin deficiency that characterizes these patients. This defect is believed to be     due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Nevertheless, the     impact of the defect on glucose tolerance is not fully understood. The so-called     gastrointestinal-mediated glucose disposal (GIGD) is a measure of glucose handling, which     includes the incretin effect, but also other factors affecting glucose disposal (e.g.     glucagon secretion). Interestingly, patients with type 2 diabetes exhibit elevated plasma     glucagon levels in the fasting state, and glucagon concentrations fail to decrease     appropriately and may even increase in response to ingestion of glucose and show exaggerated     increases after a mixed meal. With the current project the investigators wish to elucidate     how this paradoxical glucagon response observed in patients with type 2 diabetes affects the     GIGD, the incretin effect and postprandial glucose excursions.      Ten patients with type 2 diabetes and 10 healthy matched control subjects will be enrolled in     this randomised, placebo-controlled, double-blinded study. The aim is to examine the effect     of a glucagon receptor antagonist (GRA) on gastrointestinal-mediated glucose disposal (GIGD),     incretin effect and postprandial glucose excursions in patients with type 2 diabetes and     healthy controls. Participants will attend two oral glucose tolerance tests (OGTT), two     isoglycaemic iv glucose infusion (IIGI) and two standardised liquid meals.   "
47070|NCT02669511|"     An open-label, non-randomized, two-stage, multicenter study evaluating clinical efficacy,     safety and pharmacokinetics of PQR309 in patients with relapsed or refractory Primary Central     Nervous System Lymphoma (PCNSL).   "
47071|NCT02669498|"     Two recently published articles need to be cited to explain the rationale for our study since     both studies conclude with contrary findings: The first one is The post-reproductive     Fallopian tube: better removed? and the other is termed Factors associated with age of     onset and type of menopause in a cohort of UK women.      In essence, while Dietl et al suggest to remove the Fallopian tube routinely in every     hysterectomy and every sterilization procedure after 35 yrs of age, Pokoradi et al showed     that pelvic surgical procedures and even simple tubal sterilization are associated with an     earlier menopause. Hence, this is an important issue as early menopause leads to adverse     health status.   "
47072|NCT02669485|"     The aim of this study was to evaluate the impact of fluorescence imaging on the location of     colorectal transection lines based on evaluation of perfusion with indocyanine green, how     it's going to affect surgical planning and its possible benefits in reducing anastomotic     leakage.   "
47073|NCT02669472|"     Live Well, Viva Bien (LWVB) is an NCI-funded, cluster randomized controlled trial (RCT) that     was conducted in 15 subsidized housing complexes to evaluate the efficacy of a multicomponent     intervention comprised of a year-round, discount, mobile fresh F&V market -'Fresh To You'     (FTY)- that was paired with a nutrition education component including included educational     newsletters, campaigns, taste-testings and videos in both English and Spanish. The primary     aim of the LWVB grant was to study the efficacy of FTY combined with a     motivational/educational intervention to see if it increased F&V consumption compared to a     Comparison intervention (attention placebo).   "
47074|NCT02669459|"     The purpose of this study is to investigate if imiquimod can be used as a non-invasive option     in the treatment of residual/recurrent CIN lesions.   "
47075|NCT02669446|"     This a comparative, open label, parallel group, non interventional study which compares the     tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges     containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation     takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by     the physician and by the patient in a dairy.   "
47076|NCT02669433|"     This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients     with dementia with Lewy bodies.   "
47077|NCT02669420|"     The majority of second-trimester pregnancy termination performed in the United States are     performed surgically by dilation and evacuation. The frequency of induction of abortion     increases as gestational age advances. In the late second trimester and early third     trimester, induction is the primary method of termination in cases of fetal abnormalities. In     many other countries, however, induction is the primary method of abortion throughout the     second trimester   "
47078|NCT02669407|"     Patients admitted for acute heart failure and undergoing right heart catheterization will be     enrolled in this study. Subjects will undergo catheterization of the heart to obtain central     cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will     undergo a regional nerve block of the splanchnic nerves. Patients will remain in the     catheterization lab for the duration of anesthetic block and will be continuously     hemodynamically monitored.      This study will be a prospective, uncontrolled clinical trial. The study will not be     controlled as invasive monitoring of hemodynamics will be performed, allowing clear     demonstration of a cause-effect relationship. The goal of the study is to provide proof of     concept.   "
47079|NCT02669394|"     The investigators will conduct a proof-of-concept randomized controlled trial study to     provide preliminary evidence of efficacy of a resistance exercise training program for     maintaining white matter integrity and improving cognitive function in older adults with     vascular cognitive impairment, compared with a stretch and relaxation program.   "
47080|NCT02669381|"     Phenylalanine is an essential amino acid that people need to obtain in their diets. Amino     acids are the building blocks for protein, which is required to form tissues in the body. It     is well known that pregnant women require more protein in their diets, but the exact amount     for each amino acid is undetermined. To find out how much of phenylalanine pregnant women     require, the investigators plan to study pregnant women in early and late gestation with a     modern minimally invasive technique.   "
47081|NCT02669368|"     This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose     rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic     cholecystectomy.   "
47082|NCT02669355|"     Doctor's attire acts as an important criteria in setting up good relationship between patient     and physician. Recent evidence as well as strong viewpoints have highlighted the possible     harm of wearing a white coat. In order to get the patient's perspective on the same, this     observational study is being conducted to determine the effect of wearing a white coat on     patient satisfaction in an Indian setting , in patients who visit rheumatology outpatient     department,in Columbia Asia Hospitals,Bangalore,India.   "
47088|NCT02669277|"     To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed     by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.      The platelet response rate is defined as the percentage of subjects responding to treatment     with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 100 x 10^9/L and absence of     bleeding (complete response) or platelet count ≥ 50 x 10^9/L and at least 2-fold increase the     base line count with absence of bleeding (partial response), within the specified time frame.   "
47089|NCT02669264|"     This study evaluates ADCT-402 in patients with relapsed or refractory B-cell lineage acute     lymphoblastic leukemia (B-ALL). Patients will participate in a dose-escalation phase (Part 1)     and dose expansion (Part 2). In Part 2, patients will receive the dose level identified in     Part 1.   "
47112|NCT02668965|"     The purpose of this study is to determine whether intrauterine hCG can improve the     implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.   "
47090|NCT02669251|"     Background:      Bronchiolitis obliterans syndrome (BOS) is a complication people can experience after     hematopoietic stem cell transplant. It usually affects people with chronic graft versus host     disease (cGVHD). This occurs when donor stem cells attack the cells of the person who     received them. BOS reduces airflow and oxygen levels in the body. It may be caused by     neutrophil elastase in the body. Researchers believe the new drug AZD9668 may help.      Objectives:      To test the safety of AZD9668 and see what dose best inhibits neutrophil elastase in people     with BOS after a stem cell transplant. To study how well the best dose improves lung function     in those people.      Eligibility:      Adults 18 and older who have had a hematopoietic stem cell transplant and have cGVHD and BOS.      Design:      Participants will be screened with a medical history, physical exam, and blood and urine     tests. They will have lung function and heart function tests. They will have computed     tomography scans of the chest.      Study part 1: Participants will take the starting dose of the study drug by mouth twice a day     for 14 days. This is 1 cycle. They will get different doses, for up to 4 cycles.      Study part 2: Participants will take the study drug twice a day by mouth at the dose set in     part 1, for up to 12 months.      Participants will keep medicine diaries.      Participants will have several study visits. These may include:      Repeats of the screening tests.      Bronchoscopy with bronchoalveolar lavage.      Sputum samples taken.      6-minute walking test.      cGVHD assessment and answer questions.      Participants will be contacted after the study for up to 24 months.   "
47091|NCT02669238|"     Endometriosis is a chronic relapsing disease characterized by the presence and proliferation     of endometrial glands and stroma outside the uterus. This is a serious disease, widespread,     difficult to live with for the patients, but also difficult to treat for practitioners who     take care of these patients. It affects 1.6% of the general population, but its incidence is     10 times higher (up 40%) in patients with infertility. It occurs mainly by complex chronic     pelvic pain and a negative influence on fertility.      It is a disease whose complexity can be explained to four levels. Firstly, through its     extremely polymorphic character with intraperitoneal superficial forms, ovarian forms and     deep sub-peritoneal forms.      Secondly by the plurality of the main symptoms which are individually non-specific and the     frequency and / or intensity is not correlated with the severity of the disease. This     non-specificity of symptoms partially explains the long lead misdiagnosis, which vary by 5 to     11 years.      Thirdly, by its prevalence which seems very high and largely underestimated. If its precise     estimate in the general population is so complicated, it seems very high in many studies of     patients supported surgically for gynecological reasons. These very large prevalence figures     are observed when some consultations support the hypothesis of a widespread and probably     insufficiently evaluated disease.      Lately by its management, insufficiently amended, for which there is currently only a few     scientifically supported recommendations.      Chronic pain caused by the disease associated with altered sexuality to a loss of fertility     significantly impacts the quality of life of patients.   "
47092|NCT02669225|"     Background:      Brain activity creates waste products. The body s glymphatic system removes this waste,     especially during sleep. One brain waste product is amyloid-beta (Ab). It plays a role in     Alzheimer s disease. Researchers want to study the effect of sleep on Ab in the brain.      Objective:      To see if sleep affects the amount of waste product removed from the brain.      Eligibility:      Healthy people at least 18 years of age.      Design:      Participants will be screened with a medical history, physical exam, and blood and urine     tests. They will answer questions about drug use, psychiatric history, and family history of     alcoholism or drug use. Participants will complete an MRI screening questionnaire.      Participants will stay in the clinic overnight two times. On one night they will sleep     through the night. On the other night they will be kept awake all night. These overnight     visits can happen in any order.      Participants will wear 2 activity monitors, on the wrist and the ankle.      Participants will have positron emission tomography (PET) scans. A small amount of a     radioactive chemical will be injected through an intravenous (IV) catheter. Participants will     lie on a bed that slides into the scanner. A cap or a special mask may be placed on the     participant s head.      Participants will have magnetic resonance imaging (MRI) scans. The MRI scanner is a metal     cylinder in a strong magnetic field. Participants will lie on a table that slides into the     cylinder. A device called a coil will be placed over the head. Participants will do a task on     a computer screen in the scanner.      Participants will have tests of thinking, memory, and attention. They may be interviewed,     complete questionnaires, take pen-and-paper or computer tests, and perform simple actions.   "
47093|NCT02669212|"     Background:      Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to     long-lasting and disabling fatigue or malaise, inability to recover after exercise, and     physical and emotional discomfort that may occur after a person has an infection. Researchers     want to learn more about its causes.      Objective:      To learn more about PI-ME/CFS.      Eligibility:      Adults ages 18-60 years who have finished at least 7th grade education and either:      have ME/CFS that started after an infection      OR had Lyme disease, were treated, and returned to normal health      OR are healthy volunteers      Design:      Participants will initially have a 2-5 day inpatient visit at the National Institutes of     Health Clinical Center in Bethesda. During the visit, participants will have:      Medical history      Physical exam      Intravenous (IV) line. A thin plastic tube is inserted into a vein.      Blood and urine collected      Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of     their brain. They may get a dye through their IV.      Grip strength tested      Saliva, cheek swab, and stool collected      Tilt table test with measures of body functions such as sweating and breathing, blood     pressure, and heart rate and blood and urine sample collection      Collection of blood cells. Participants can choose to have the blood drawn through the IV or     through a machine that filters blood cells and returns the liquid blood back into the     participant s vein.      Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.      Heart monitoring      Sleep study for participants with PI ME/CFS      Questions about the participant s life and how they are feeling      Questions from a neuropsychologist      Questions from an occupational therapist for participants with PI ME/CFS      Questinos from a nutritionist      After the initial visit participants will return home. Participants evaluated for PI-ME/CFS     during the first visit will have their information reviewed by an adjudication panel of     experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate     in the second study visit.      Eligible participants will be invited back for a second study visit. If a participant was     taking certain medications during the first visit, they may be asked to taper off of them     prior to the second visit and report any problems. They will also receive an activity     monitor, fatigue diary, and nutrition log to use for at least one week prior to their second     visit.      Participants who are eligible will return for a 5-10 day inpatient hospital visit at the     National Institutes of Health Clinical Center. During the visit, participants will undergo     measurements before and up to 96 hours after performing a stationary bike exercise test. The     purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests     will be performed before and after exercise testing. These include:      Sleeping in a room that measures how the body uses energy with EEG monitoring      Eating a controlled diet      Performing vigorous exercise for 10-15 minutes      Questions about how participants are feeling      Questions about what participants usually eat      Samples of saliva, blood, urine and stool      Wearing an activity monitor      Having an Xray that measures body composition      Thinking and memory tests      Heart monitoring      Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic     pulse that affects brain activity.      Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of     their brain. They will do thinking and exercise tasks during the MRI.      Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.   "
47094|NCT02669199|"     The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs)     UC between source sample sweat gland cells wound transplanted effectiveness and safety for     the treatment of large area skin lesions of the subjects   "
47095|NCT02669186|"     The proposed study is a pilot prospective, single-blinded, randomized controlled trial     evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural     killer cell population size and cytotoxicity in patients undergoing exploratory abdominal     laparotomies.   "
47220|NCT02667535|"     This is a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of     Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy     volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and     healthy volunteers will receive 2.0% dose. All treatment will last 7 days.   "
47096|NCT02669173|"     This study involves participants with recurrent glioblastoma brain tumors (GBM). This means     that a participant's brain tumor has either returned after being treated by a previous     therapy, or has continued to progress despite being treated.      The purpose of this study is to provide proof of concept that suppression of MDSCs     (myeloid-derived suppressor cells) is feasible in patients with GBM. Rather than targeting     tumor cells or immune checkpoints, which has been the focus of recent therapeutic efforts,     direct targeting of MDSCs with low dose capecitabine has the potential to reverse the     immunosuppressed microenvironment of GBM and thereby reduce tumors   "
47107|NCT02669030|"     Depression with ongoing insomnia is a common clinical presentation with patients. Clinical     data suggests that patients with insomnia that receive concomitant treatment with a sleep aid     experience a more robust antidepressant response along with a quicker response. The purpose     of this clinical study is to compare the effectiveness of the FDA-approved insomnia     medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to     that of placebo plus antidepressant treatment in patients with depression and residual or     ongoing insomnia.   "
47097|NCT02669160|"     Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance,     gait and movement disruptions. These disorders are related to lesions of the central nervous     system (CNS) that occurs at birth or during the early childhood. The therapeutic management     of CP is essentially based on reeducation, but may also require specific medical treatments,     orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed     in specialized institutions with a significant socioeconomic impact. CP children suffer from     various sensorimotor impairments, which may evolve into orthopedic deformations, justifying     the implementation of restrictive devices. The French High Authority of Health (HAS)     estimates that 50 % of CP children have pains when using contention or verticalization     devices. These pains are mainly nociceptive and are caused by the passive constraint applied     on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients     have led to controversial results regarding the duration of the effect of this therapeutic     approach. However, the improvement is more important when neuromuscular facilitation     techniques are added to the reeducation program. Human neuronal adaptation and plasticity     mechanisms are now understood, with the possibility of a potential partial recovery.     Non-invasive stimulation methods and neurorehabilitation techniques could participate in the     CNS re-calibration. Automated assisted movements have already been used and these processes     showed an increase joint range of motion, bone density and decreased spasticity.      In recent years, exoskeleton devices have been used on subjects with spinal cord injuries     allowing motor performances improvement.      This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing     walking pattern compared with conventional passive standing-up devices. For this clinical     trial, the investigators compare the behavior of CP children using a motorized orthosis     reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in     their usual conventional passive device. The investigators hypothesis is that the Innowalk     improves joints range of motion, enhances selective motor control, decreases the medium-term     spasticity and offers at least the same tolerance as conventional passive devices.   "
47098|NCT02669147|"     This is a prospective observational study to evaluate effectiveness and safety of     Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to     administer Enzalutamide after anti-androgen therapy.      CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and     decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and     observed the practical treatment. Total research term is for 4 years, consists of 2-year case     registration terms and 2-year observational terms.   "
47099|NCT02669134|"     The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR     improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6     months of treatment. In this investigator-initiated, multi-centre, 2:2 factorial design,     randomized, two-arm, double-blinded, cross-over, prospective trial, CRT recipients will be     randomized to 'SonR' atrioventricular (AV) and ventricular-ventricular (VV) optimization or     'fixed settings'. The primary endpoint is an absolute reduction in left ventricular     end-systolic volume.   "
47100|NCT02669121|"     The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4     Bivalent Virus-Like Particle Vaccine against moderate or severe acute gastroenteritis (AGE)     due to genotype-specific (GI.1 and GII.4) NoV strains.   "
47101|NCT02669108|"     The primary objective of this study is to explore feasibility of testis functionality     assessment and testis imaging obtained from Positron Emissions Tomography (PET) /Magnetic     Resonance Imagine (MRI). Using advanced MRI metrics, investigators will study the     three-dimensional structure of normal testis, the levels of specific elements and compounds     in the tissues (which can only be found via these imaging techniques), and the directionality     (and alterations in directionality) of tissue structure. Investigators hope to develop     hypothesis that will in turn suggest bio-markers to be explored in subsequent clinical     trials.   "
47102|NCT02669095|"     This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design,     double-masked clinical trial using an investigational contact lens and a marketed contact     lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear     modality.   "
47103|NCT02669082|"     This study will explore the effect of ramelteon 8 mg once daily for 8 weeks for the treatment     of insomnia patients with depression by using actigraphy.   "
47104|NCT02669069|"     This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation     treatment for tinnitus.   "
47120|NCT02668848|"     The investigators previously found that a blood urea nitrogen/creatinine (BUN/Cr) ratio >15     is an independent predictor of early deterioration after acute ischemic stroke. Another study     was conducted to determine whether urine specific gravity, another indicator of hydration     status and one more easily obtained, is also an independent predictor of early deterioration     or stroke-in-evolution (SIE) in such patients. The investigators also conducted a preliminary     study, enrolling ischemic stroke patients with a BUN/Cr ratio >15 and find daily Bun/Cr based     hydration help to decrease post stroke infection rate and improve 3 months functional     outcome. In this study, daily urine specific gravity will be used to adjust hydration therapy     in ischemic stroke patients with initial Bun/Cr ratio <15. The primary outcome is the post     stroke infection rate in the first 7 days after admission, and secondary outcome is 3 months     functional outcome using mRS.   "
47162|NCT02668289|"     The purpose of this trial is to determine the correlations between various tissue dimensions     and the changes that occur following a single-tooth dental extraction in human adults.      65 adult subjects who are in need of dental extractions will be recruited. Clinical     measurements will be gathered prior to and immediately following the single tooth extraction.     There will be a 2-week post-operative visit to assess healing and a 14-week follow-up for     photographic documentation and clinical measurements of the extraction area.   "
47105|NCT02669056|"     Although significant advances in neonatal care have increased survival rates of preterm     infants born before 28 weeks gestation, a concomitant decrease in neuro developmental     disorders has not been achieved. Cerebral injuries, well documented during the previous     years, in preterm babies are particularly deleterious since they occur in a developing brain.     They affect both white and grey matter by complex mechanisms and the principal targets are     the developing oligodendrocytes and neurons of the subplate. All these criteria define the     encephalopathy of prematurity. Nevertheless, the consequences of prematurity at the level of     the brainstem are not very well known and may explain neuro-developmental disorders with     normal MRI.      The assessment of the motor repertoire is complementary to the neurological examination and     may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed     acquisition in children. The newborn have a rich motor repertoire. GMs play a key role in the     development due to the feedback that they send to cortical neurons and reflect the     maturational stage of the Central Nervous System (CNS). Lesions of the brainstem caused by     prematurity may induce alterations of the motor repertoire.      Dysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently     in very preterm babies reflect brainstem abnormalities. These symptoms are also described in     other pathologies, in Rett syndrome and sudden infant death syndrome (SIDS). In these     pathologies deficits of the 5-HT system have been described and associated with dysautonomia.     It would then be interesting to evaluate 5-hydroxytryptamine (5-HT) levels in very preterm     babies.      The serotonergic system develops very early during gestation and is one of the first     neurotransmitter to appear in the developing brain. The main 5-HT nuclei are located within     the brainstem. 5-HT plays an important role in the homeostasis and the modulation of the     respiratory network. Moreover, previous studies have shown that 5-HT projections to the     spinal cord are involved in posture and in the coordination. It is tempting to think that     5-HT deficits may have some repercussions on the development of the CNS, changing activity     dependent processes, such as spontaneous activity recorded at the spinal level in rodents.      In this project, the 5-HT platelet levels in preterm infants born before 28 weeks will be     compared with newborns. a correlation between the levels of 5-HT with MRI of the posterior     fossa, GMs and dysautonomia different parameters such as heart rate variability,     suction-swallowing and different breathing techniques will be established   "
47106|NCT02669043|"     Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with     anxious depression do not respond as well to currently available antidepressant medications.     Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of     depression within hours in many patients with treatment-resistant depression, has been     associated with superior efficacy in those individuals with anxious compared with non-anxious     depression. In order to understand this unique effect more fully, the current protocol is     aimed at further delineating biomarkers of ketamine's effects among individuals with     treatment-resistant anxious depression compared to those with nonanxious depression.   "
47108|NCT02669017|"     This study evaluates ADCT-402 in patients with Relapsed or Refractory B-cell Lineage Non     Hodgkin Lymphoma (B-NHL). Patients will participate in a dose-escalation phase (Part 1) and     dose expansion (Part 2). In Part 2, patients will receive the dose level identified in Part     1.   "
47109|NCT02669004|"     Patient-controlled Intermittent epidural bolus versus epidural infusion for posterior spinal     fusion after adolescent idiopathic scoliosis.      Scoliosis surgery is commonly performed in adolescent due to idiopathic scoliosis. It is     reported that the postoperative pain after scoliosis surgery that occurs due to Surgical     trauma and severe reflex muscle spasm be severe and excruciating. There are many methods for     postoperative pain management. It is used often opioid , paracetamol and non-steroidal     anti-inflammatory drug with patient- controlled intravenous analgesia (IV-PCA). In addition;     intrathecal opioids, one catheter epidural with intermittent dosing bolus of morphine or     continuous infusion (either opioids or local anaesthetics or both), double epidural catheter     with continuous infusion and intravenous ketamine infusion were preferred other postoperative     pain management models.      Epidural analgesia is accepted procedure with the efficacy and safety profile for     postoperative pain management in major orthopedic surgery including scoliosis surgery.     Epidural analgesia techniques commonly have been used in continuous infusion of local     anesthetics with or without opioid. It was emphasized that there was not adequate data in the     literature to provide argument concerning the use of epidural opioids after spinal surgery.     The objective of this study was to compare the effects and side effects patient- controlled     intermittent bolus epidural analgesia (PCIEA) and patient- controlled continuous epidural     analgesia (PCCEA) with morphine for postoperative pain control in adolescent idiopathic     scoliosis after posterior spinal fusion.      Methods The study was conducted after obtaining written consent from all patients and     guardian, approval from the Inonu University Faculty of Medicine Ethics Committee. This     prospective randomized controlled double-blinded study was conducted 47 patient between 8-18     years, American Society of Anesthesia Classification (ASA) I-II, with idiopathic scoliosis,     scheduled for elective posterior spinal fusion.      Patients with a history of allergy to the drugs used in the study protocol, drug abused ,     preoperative neurologic deficit, inability to use a visual analogue scale, pulmonary, cardiac     and neuropsychiatric disorders were excluded. Exclusion criteria during the study were     accidental perforation of dura, faulty epidural catheter placement, postoperative neurologic     deficit or uncontrollable nausea, vomiting and pruritus.      The patients who were not premedicated were instructed on the visual analog scale (VAS) and     the patient-controlled analgesia (PCA) device that was implanted during the postoperative     period.      Patients were divided into two groups using the envelope drawing method. Patients who     received epidural morphine with PCIEA represented Group 1, epidural morphine with PCCEA     represented Group 2. The anesthetist who collected data and the patients were blinded.      All operations were performed by the same surgical team. The posterior instrumentation with     pedicle screws was applied to thoracic and lumbar spine. Epidural catheter was inserted by     surgeon under direct visualization at the midpoint of the incision and advanced 5-6 cm     cephalad to thoracic 4-5 before surgical closure. Intubated patients was taken to in the     reanimation intensive care unit after operation, IV acetaminophen 15 mg / kg was started     before extubation and repeated every 6 hours.      After extubation and a neurological examination, patients in the PCİEA group received     morphine 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion. In Group 2, PCECA     infusion the following initial setting loading morphine 0.02mg/kg in 8mL, was maintained 0.01     mg/kg continuous infusion 4mL, 0.05 mg/kg 2mL bolus dose. 30 minute lock-out interval. 4 hour     limit was 4 mg/kg.      Pain score, morphine usage, postoperative nausea and vomiting, pruritus, rate their     satisfaction ,sedation scores and motor block were assessed by researchers who were blinded     to the study groups at postoperatively 2., 4., 6., 8., 12., 18., ve 24.hour, in all patients.   "
47113|NCT02668952|"     Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models,     excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid     has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold     under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI     outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The     investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients     (up to 40 enrolled) into 2 study arms and compare renal outcomes.   "
47114|NCT02668926|"     The study will compare the acute emotional and endocrine effects of equivalent doses of     lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and     effects of the amphetamines on aspects of social cognition are investigated.   "
47115|NCT02668913|"     This is a pilot feasibility study assessing the use of a commercial molecular profiling     service in the UK's National Health Service (NHS). The impact of knowledge of a patient's     molecular profile, and the time it takes to generate this knowledge, will be assessed by     analysis of changes in physicians' treatment decisions prior to and following generation of a     patient's molecular profile. Implications for benefit with therapies recommended by the     profile will also be assessed and the following treatment outcomes collected: best response     (based on routine clinical, radiological and biochemical assessment), progression free     survival ratio (post Caris Molecular profiling versus prior treatment) and overall survival.   "
47116|NCT02668900|"     The implantable-cardioverter defibrillator (ICD) is a small medical device used to treat     dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD     can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. ICD     therapy has risks and benefits that should be weighed from each patient's perspective. An ICD     battery needs to be surgically replaced 4 to 7 years to ensure ongoing function. At present,     the majority of these batteries are automatically changed without eliciting patients'     preferences. There is a need for a better way to engage with patients. Patients want to be     involved in their healthcare decisions, yet more than half of patients with an ICD do not     know that ICD replacement is optional. To ensure that patients are receiving treatment that     they value and want, members of the interprofessional team should ensure that treatment     decisions align with patients' expectations, values and preferences. This rests on the     principle of shared decision making in which members of the healthcare team and patients     deliberate together to arrive at a decision which best reflects the preferences and values of     the patient. To facilitate the achievement of this goal, a patient decision aid (PDA) can be     used. As a result, the investigators developed PDA for ICD replacement. The purpose of this     feasibility trial is to collect preliminary data to test the feasibility of conducting a     larger trial, and to evaluate the PDA for its acceptability and ease of use. Eligible and     consented participants facing ICD replacement will be randomized to receive the decision aid     or to usual care. The investigators will assess if this decision aid can improve     participants' knowledge on ICD therapy and the replacement surgery, increase patients'     perceived involvement in the decision, and determine whether their actual choice reflects     their personal values.   "
47117|NCT02668887|"     Within the first year after diagnosis, data on employment and quality of life will be     collected and evaluated in patients with malignant melanoma   "
47118|NCT02668874|"     The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention     rates of sealants placed under Isolite vs. cotton roll isolation. This study will also     compare the patient and operator acceptability and satisfaction of the two isolation     techniques as well as the time consumed for sealant application during the two isolation     techniques.   "
47119|NCT02668861|"     The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing     in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After     Endonasal Endoscopic Sinus Surgery   "
47143|NCT02668536|"     The initial focus of the study will be on safety, sun protection factor (SPF)     characterization, and substantivity (duration of protection) studies. The primary outcome of     the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles     (BNP) formulation in 20-25 healthy volunteers with fair skin.   "
47144|NCT02668523|"     The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near     Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and     intermediate vision.   "
47121|NCT02668835|"     The proposed study will capitalize on the early predictive information stored in an     individual's genetic risk for Parkinson Disease (PD) in combination with the subtle features     of tremors that can be extracted from movement data gathered by modern compact accelerometers     in order to determine if accurate discrimination of essential tremor (ET) from PD can be     achieved. Both of these technologies have a proven but somewhat limited ability to inform     diagnosis of PD or differentiation of PD from ET - especially at early stages of the disease.     The investigators hypothesize that a combination of prior genetic risk and current disease     symptomology can synergize for accurate and early discrimination of PD from ET and ultimately     inform a cost effective approach to movement disorder diagnosis.      In this study, the investigators will collect blood from individuals with confirmed     late-onset diagnosis of PD and ET. Gold standard diagnosis status will be determined via the     Unified Parkinson's Disease Rating Scale (UPDRS) - the accepted clinical gold standard for     Parkinson's Disease diagnosis. DNA will be extracted from blood samples to characterize the     genetic risk of individuals for PD via proven genetic risk models. In addition, participants     will wear a wristwatch-like accelerometer device that will track their movements (tremors) at     high temporal resolution and transmit movement data via a smartphone. Cognitive distraction     tasks will be administered via mobile phones while simultaneously collecting movement data.     Predictive tremor features will be extracted from movement data via signal processing     approaches - e.g. discrete wavelet transformation. A final predictive model combining     movement tracking information and genetic information will be designed in attempt to     distinguish PD from ET individuals.   "
47122|NCT02668822|"     The purpose of this study is to evaluate the efficacy of the etonogestrel (ENG) +     17β-estradiol (E2) vaginal ring compared to placebo vaginal ring in the treatment of     dysmenorrhea at Treatment Cycle 2. This study will also assess the safety and tolerability of     the ENG-E2 vaginal rings over 4 treatment cycles. Primary hypothesis: Relative to the placebo     ring, the ENG-E2 vaginal ring results in a greater proportion of participants with a ≥ 3     point reduction in peak pelvic pain score and no increase in the number of rescue pain relief     (ibuprofen) tablets taken at Treatment Cycle 2 as compared to baseline.   "
47125|NCT02668783|"     The purpose of this study is to assess the etonogestrel (ENG) + 17β-estradiol (E2) vaginal     ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at     Treatment Cycle 2. In addition, this study will assess the safety and tolerability of the     ENG-E2 vaginal rings. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal     ring results in a greater proportion of participants with a ≥3 point reduction in peak pelvic     pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at     Treatment Cycle 2 as compared to baseline.   "
47126|NCT02668770|"     The goal of this clinical research study is to find the highest tolerable dose of MGN1703     that can be given in combination with ipilimumab to patients with advanced tumors. The safety     of this drug combination will also be studied.   "
47127|NCT02668757|"     The HeartHab study is a pilot trial in which coronary artery disease patients (n = 15-30) are     given the HeartHab application. The HeartHab application is a smarthphone based mobile     application that serves as a secondary prevention tool, to support cardiac patients after     their phase II cardiac rehabilitation program. During study period (4-6 weeks), participating     patients will be asked to use the application. HeartHab includes a module devoted to therapy     compliance, one to exercise training prescription and one to risk factor control. HeartHab     aims to motivate the patient to improve his/her self-management skills and hence decrease     cardiovascular morbidity (and mortality).      Motivational aspects and usability data will be collected during study period by means of app     logs and/or questionnaires/interviews.   "
47128|NCT02668744|"     The investigators recently completed an NIH R21 grant, which was a randomized controlled     trial (RCT) to test the effects of a gardening, nutrition, and cooking program in 375     low-income Hispanic students living in Los Angeles. Preliminary results from this study show     that intervention compared to the control students have reductions in BMI parameters and     waist circumference, increases in daily intake of dietary fiber and vegetables, and improved     lipid profiles. The investigators want to expand and replicate this study by: a) using a     cluster randomized school design; b) implementing the program during school hours; c)     increasing sample size; d) lengthening the intervention period to one school year; e)     collecting comprehensive metabolic measurements on the child; f) enhancing family workshops;     g) collecting more parental data; and h) developing and evaluating sustainability strategies.     Thus, the overall goal of this project is to test the effects of a large school-based     gardening, nutrition, and cooking RCT (called Sprouts) on dietary intake, dietary-related     behaviors, obesity, and related metabolic disorders in low-income Hispanic youth and their     families in Central Texas. Sixteen elementary schools will be randomized to either: 1)     Sprouts intervention or 2) Control (delayed intervention). At each intervention school, the     investigators will build edible gardens; form and train Garden Leadership Coalitions (GLCs);     teach 20 Sprouts in-school lessons to the students; and teach nine family-based Sprouts     lessons throughout school year. The following measures will be obtained for students at     baseline and post-intervention: height, weight, BMI, waist circumference, body composition     (via bioimpedance), blood pressure, glucose, insulin, and lipids (via voluntary fasting blood     draws), dietary intake, and related psychosocial behaviors (e.g.,     preference/motivation/self-efficacy to eat FV). The investigators will also measure     anthropometrics, dietary intake, and related dietary psychosocial variables on the parents at     baseline and post-intervention. After the intervention year, the investigators will provide a     series of training workshops and resources to the GLCs and schoolteachers to sustain the     Sprouts program in subsequent years. The investigators will measure the sustainability     employed by each school by process logs/surveys, structured interviews, and school     observations.   "
47129|NCT02668718|"     The purpose of this study is to determine whether adjuvant radiotherapy following radical     prostatectomy in prostate cancer patients with positive margins or capsular penetration     improves biochemical, overall and/or cancer specific survival and whether adjuvant     radiotherapy is reasonably well tolerated when compared to watchful waiting.   "
47130|NCT02668705|"     Both the main and sub-studies will investigate how consent forms and other health care     documents are explained to patients. The findings will be used to create a computer program     that can successfully explain consent and other health-related forms to individuals who have     difficulty reading and understanding consent forms on their own as a supplement to the normal     consent process done in research settings.   "
47131|NCT02668692|"     To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment     of psoriasis in Japanese subjects.   "
47145|NCT02668510|"     A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with Platelet     Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with Resistant     Plantar Fasciitis   "
47221|NCT02667522|"     The purpose of this study is to test causal links between dimensions of positive and harsh     parenting and children's brain responses to rewards and errors, using a parenting     intervention.   "
47132|NCT02668679|"     Background: Performance of endoscopy in children requires more patience, experience, and     expertise than in adults. The anxiety of the children is related to parent's separation, loss     of self-control, unknown surroundings and strange people that are taking care of them, and     frequently unpleasant or even painful procedures. Painful and frightening procedures in     children have been shown to result in short-term physiologic changes and long-term behavioral     changes. The response to unpleasant stimuli with stress and fear may be exaggerated in     children and experienced as pain. Most infants and children and many teenagers need deep     sedation or light general anesthesia to complete a successful and safe procedure. Induction     of general anesthesia is a stressful procedure itself. Strategies to reduce preanesthesia     anxiety include pharmacologic and non-pharmacologic interventions.      However, this evidence is based mainly on self reports rather than objective measurements.     Therefore, objective and non-invasive measurements to be utilized in the current study,     should provide an assessment tools regardless the children's age.      Multiple studies, beginning in the 1970's, have shown that humor has many positive effects on     physical and mental health and well-being. Previous investigations have reported that humor     has beneficial effects on the immune system, stress related to potentially fatal illnesses,     pain tolerance, and mental functions.      Dream doctors (DDs) are professional medical clowns or stage artists, who received training     specifically to understand medical patient's need and to give the patient adjuvant therapy     during hospital admissions or ambulatory treatment.The Israel dream doctors project,     integrates professional medical clowning into the medical services provided at Israeli     hospitals.Studies already proved that presence of medical clowns significantly reduces the     level of anxiety during induction of anesthesia in children. Hypothesis of the study: 1) DDs     lessen the level of anxiety and attention impairment in children undergoing gastroscopies. 2)     DDs improve the satisfaction of children and their parents during gastroscopies.      The aim of this study is: 1) To explore the influence of DDs on the satisfaction of children     and their parents undergoing gastroscopy, utilizing questioners. 2) To explore the effects of     DDs on anxiety and attention of children and their parents, undergoing gastroscopies by means     of GSR, startle response and pre-pulse inhibition (PPI) tests, as well as , and measuring     anxiety-related biologic indices.   "
47133|NCT02668666|"     This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib     in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not     received prior systemic anticancer therapies for their advanced/metastatic disease.   "
47135|NCT02668640|"     The study is a non-interventional, observational study is to assess the effect of Adalimumab     on health-related quality of life and work productivity in patients with Rheumatoid Arthritis     (RA) in China.   "
47149|NCT02668458|"     The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the     intubation procedure with two methods of pre-oxygenation:        1. NIV (Non Invasive Ventilation)        2. HFNC (High-flow nasal canula oxygen therapy)   "
47136|NCT02668627|"     Based on the results of recent randomized controlled trials, current international guidelines     recommend the initiation of endovascular treatment within 6 hours of symptom onset for acute     ischemic stroke. Endovascular treatment may be beneficial in selected patients beyond 6 hour     time window. In particular, treatment response to endovascular therapy may be greatly     influenced by pretreatment collateral status. The aim of this study is to evaluate whether     MRI-based collateral imaging (the Fast Analysis SysTem for COLLaterals, 'FAST-COLL') is     feasible and can predict the response to endovascular treatment in a wide range of patients     with acute ischemic stroke .   "
47137|NCT02668614|"     Skin cancer represents a large problem in today's healthcare setting. The majority of cancer     diagnoses are attributed to malignant skin diseases including its major types: basal cell     carcinoma, squamous cell carcinoma and melanoma. Early diagnoses is critical given early     detection of malignant lesions largely increases chances of successful treatment. The current     gold standard of diagnosis is histopathological examination of biopsied skin. Biopsies are     not only invasive and expensive, they have variable positive predictive value, meaning they     may often be preformed unnecessarily. As such, we have developed a skin scanner, which is     less bulky and expensive that existing similar technologies, as a tool to evaluate skin     lesions prior to determining the need for a biopsy. Our objective is to obtain information in     order to validate this skin scanner in the context of its ability to accurately identify     basal cell carcinoma skin lesions.   "
47138|NCT02668601|"     Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic risks     in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to GDM will     be associated with one or more of three critical factors involved in the development of     diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function     in Hispanic children when compared to non-exposed children matched for ethnicity, age,     gender, and Tanner stage. In a subset of this cohort, we will also examine the effects of     intrauterine exposure to gestational diabetes on the brain pathways that regulate appetite     and body weight in children ages 6 to 15 years old.   "
47139|NCT02668588|"     This is a multicentre, double blind, randomized placebo controlled trial to assess the effect     of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node     Dissection (ALND).      Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.   "
47140|NCT02668575|"     Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor     quality of life, and additional psychosocial stressors; these burdens are particularly     heightened in advanced stages of the disease. Although supportive care (aka palliative care)     has been shown to improve many of these outcomes among patients with illnesses such as     cancer, no clinical trials to date have tested the impact of supportive care for patients     with CF. The purpose of this pilot randomized clinical trial study is to evaluate the     feasibility, acceptability, and perceived effectiveness of an embedded supportive care     intervention, whereby a supportive care specialist will be integrated within the usual care     experience of patients with advanced CF. The investigators will enroll 50 patients with     advanced CF, who will be equally randomized to receive this embedded supportive care     intervention or usual care. Secondary measures include: patient quality of life, mood, coping     style, satisfaction with care, and symptom burden. This study will provide preliminary data     to support the development of a larger, definitive, Phase III randomized clinical trial.   "
47141|NCT02668562|"     Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac     events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line     therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased     bleeding. This may be of particular concern for patients with ACS who require coronary artery     bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before     proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate     the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS     patients initially treated with ticagrelor and to identify potential mechanisms underlying     benefits or complications of early bypass surgery.   "
47142|NCT02668549|"     The purpose of this study is to formulate definitions of doctor/pharmacy shopping and     evaluate its association with abuse/addiction   "
47146|NCT02668497|"     The primary objective is to study the efficacy of botulinum toxin type A (BoNT-A) injected     via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in     Parkinson's disease (PD) tremor. Kinematic assessment tools already developed in past     clinical studies will be used in determining injection parameters. The objective is to study     the composition of PD tremor using kinematic tools which may contribute to the knowledge of     tremor complexity and contribute information that would benefit the development of injection     parameters to improve efficacy and optimization of BoNT-A in tremor management. By injecting     all bothersome tremulous upper limbs in Parkinson's disease patients, the investigators     believe a greater improvement in Quality of Life on more daily tasks can be achieved compared     to the investigator's earlier study in unilateral injections (REB#101749), which already     showed significant improvement.   "
47147|NCT02668484|"     There are different aortic valve prosthesis used for treatment of aortic valve disease     through catheter-based procedures. The current study aims to compare two different aortic     valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.   "
47148|NCT02668471|"     The purpose of this study is to compare the efficacy of ultrasound- guided with the     traditional palpation radial artery cannulation in critically ill children.   "
47150|NCT02668445|"     This is a randomized, counterbalanced crossover design, in which 14 male subjects will     complete two experimental trials. Each trial will be separated by a minimum of at least 12     days (range: 12-30 days). The study aims to investigate the effects of low glycogen     availability on skeletal muscle molecular response after a concurrent exercise day.   "
47151|NCT02668432|"     Purpose/Objectives: Severe sepsis and septic shock are a common cause of new onset atrial     fibrillation (NOAF) in the intensive care unit. Development of NOAF in this setting can     prolong length of stay and increase mortality. Amiodarone is the most commonly used agent     used in this setting to control rate and rhythm. However, limited data exist detailing     appropriate dosing in this setting. The primary objective of this study is to evaluate two     amiodarone dosing strategies, a full loading dose versus a partial loading dose, in patients     with new-onset atrial fibrillation (AF) due to severe sepsis or septic shock to assess the     mean heart rate every 6 hours after initiation of amiodarone infusion to day 7 or death.      Research Design/Plan: Consecutive patients admitted to the medical or cardiac intensive care     unit at University Hospital with NOAF in the setting of severe sepsis or septic shock will be     screened for study inclusion. Data will be collected and stored using Microsoft Excel or     Access and analyzed with JMP 12.0 and SPSS.      Methods: Patients aged 18 years or older who develop new-onset atrial fibrillation in the     setting of severe sepsis or septic shock and in whom the medical team deems appropriate to     initiate amiodarone therapy in will be considered for study inclusion. Patients will receive     intravenous (IV) and oral (PO) amiodarone, as per the standard of care. Patients will be     randomized to a certain quantitative loading dose strategy; either a full loading dose (≥ 5g     IV or ≥10g PO +/- 20%) or a partial loading dose (<4g IV or < 8g PO).      Clinical Relevance: With intensive care unit length of stay (ICU LOS) and mortality being     twice as high in NOAF with sepsis as compared to septic patients without NOAF, the     investigators ultimately aim to identify a management strategy that may minimize this     morbidity and mortality while also minimizing exposure to a drug that may cause serious     adverse effects.   "
47152|NCT02668419|"     The purpose of this study is to determine whether neuromuscular electrical stimulation can     improve exercise tolerance for patients with heart failure and continuous dobutamine use in a     hospital.   "
47153|NCT02668406|"     Clinical samples [blood and voided urine (only for phase A)] from patient recruited at     Sihanouk Hospital Centre of HOPE (SHCH) and HOPE Community Medical Center (CMC) will be     processed (decontamination) and shipped to SRI International with the purpose of design and     validation (proof of concept) and (case/control series) of in-vitro diagnostics for     melioidosis.   "
47154|NCT02668393|"     Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel     in patients with locally advanced or metastatic lung adenocarcinoma after failure of     platinum-based first line chemotherapy.   "
47155|NCT02668380|"     This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for     Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give     patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and     efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.   "
47156|NCT02668367|"     This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple     ascending dose (MAD), 7-day treatment period study in healthy subjects.   "
47157|NCT02668354|"     The aim of this study is to investigate the spectrum of various types of malignant neoplasms     of infancy, according to the experience of South Egypt Cancer Institute, which represents the     largest referral site in Upper Egypt.   "
47158|NCT02668341|"     Analysis of barriers in psoriasis care from the patient's and the physician's perspective and     generation of scientific data on the quality of health care in Denmark, Poland, Spain, United     Kingdom, and Germany   "
47159|NCT02668328|"     The proposed study is an integrative scientific undertaking, reflecting the input of experts     in the behavioral sciences, mHealth technology, computational biology, endocrinology,     biochemistry, and nutrition. The project features a unique translational approach, connecting     behavior and biology in an economical manner that provides mechanistic insights into the     progression of type 2 diabetes (T2D) and the biologic consequences of behavior change. The     project may have profound implications for the clinical management of early T2D.   "
47160|NCT02668315|"     Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients     with blood cancers, but only 25% of transplant candidates have a sibling donor. A matched     unrelated donor can be found for 60% of patients but this number is lower for non-Caucasians.     Cord blood (CB), another source of stem cells, has major advantages over unrelated donors     including immediate availability, better permissiveness in immune mismatches between donor     and transplant recipient, better availability for non-Caucasians, and less graft versus host     disease, a complication frequently seen after transplant which negatively affects quality of     life. Unfortunately, the use of CB is still limited in adults because of the small number of     stem cells. UM171, a molecule with hematopoietic stem cell expansion properties, has been     shown to increase cord blood stem cells 13 fold. In this trial, Investigators will use UM171     treated CB in patients who need a transplant but lack an acceptable donor.This protocol seeks     to test the safety of CB cells expanded with UM171, and to determine the kinetics of     engraftment as well as the minimal cord blood unit cell dose that when expanded achieves     prompt engraftment.   "
47161|NCT02668302|"     Randomized, controlled, double-blinded clinical trial with 40 patients randomized in 1:1     ratio to either treatment (bilateral in-office placement of Propel following ESS) or control     (post ESS standard of care) group and followed for 6 months   "
47178|NCT02668081|"     This study compares the effect of endoscopic sphincterotomy and endoscopic papillary balloon     dilation in the treatment of acute biliary pancreatitis.Participants with acute biliary     pancreatitis will be randomized into either the endoscopic sphincterotomy or endoscopic     papillary balloon dilation groups.Moreover, the investigators compare the results obtained     from the traditional bile/blood culture and metagenomics.   "
47192|NCT02667899|"     Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS     (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients.      Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group     and Control group. Three months after treatments, the result will be analysed and concluded.   "
47163|NCT02668276|"     This research is being done to better understand how a new lab test called the Oncotype DX     Prostate Cancer Assay may impact what treatment men decide to get and how they feel and think     about their choice of treatment. The study will compare men who receive this new lab test     with men who receive the usual counseling given to men after they get a new diagnosis of     prostate cancer. Prostate cancer is sometimes slow-growing and sometimes fast-growing.     Healthcare providers are searching for better ways to predict how each tumor will behave so     that each man can make a better decision about when to receive treatment. The Oncotype DX lab     test uses leftover prostate biopsy tissue to generate a Genomic Prostate Score (GPS). The GPS     is related to the risk of a fast-growing cancer being discovered if surgery is performed to     remove a man's prostate. The goal of this study is to find out if this test helps men when     they are deciding how their prostate cancer will be treated. Treatment options include     surgery to remove the prostate, radiation therapy, or an approach called active     surveillance in which there is no immediate therapy and the tumor is watched using prostate     specific antigen (PSA) tests and repeat biopsies.   "
47164|NCT02668263|"     Seroma formation is a common complication following breast and axillary surgery for breast     cancer. The use of drains is commonplace in practice after mastectomy, although there is     evidence to suggest that they do not affect the incidence of symptomatic seroma formation.     Methods have been adopted in attempts to decrease seroma formation, to varying results, which     include the use of deep sutures. The aim of this study is to evaluate the effect of drains     and quilting sutures on the incidence of seroma formation. Patients undergoing mastectomy and     axillary surgery for breast cancer will be eligible. Patients will be randomized to either     receive a drain, no drain or no drain with quilting sutures. The primary outcome measure will     be the incidence of symptomatic seroma. Secondary outcome measures will be postoperative     length of stay and postoperative pain scores.   "
47165|NCT02668250|"     With the increasing aging population demographics and life expectancies, the number of very     elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly     large proportion of the high-risk surgical group.      Cardiac complications and postoperative pulmonary complications are equally prevalent and     contribute similarly to morbidity, mortality, and length of hospital stay. Specific     optimization strategy of general anesthesia has been tested in high-risk patients undergoing     major surgery to improve outcomes.      Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic,     ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly     undergoing high risk surgery.   "
47166|NCT02668237|"     Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple     severity scores. The etiology is never really identified, and the initial treatment is always     based on probabilistic antibiotics, in the case of an bacterial infection, and by the way,     potentially severe.      Molecular tests (multiplex) allow the simultaneous detection of a huge number of pathogenic     agents, virus and bacteria, are now available.      This project is based on a new strategy of diagnostic, using a multiplex PCR with quick     results, coupled to an antigenic urinary test to allow a complete, quick, etiologic     diagnostic as soon as children are supported in emergency.      Children are randomized in two groups during inclusions : quick diagnostic strategy versus     usual practice. Analyse will be centralized on anti-infectious treatment optimization, with     the aim to better treat patients, minimize the costs, and decrease selection pressure of     multi-resistant bacteria.   "
47167|NCT02668224|"     It is a randomized, controlled clinical trial, in healthy volunteers. They are in two groups     : the test one will perform the vibration training (1h of Vibrasens 3 times a week, 24     sessions) whereas the control group will not be training. The primary outcome is the maximal     voluntary strength.   "
47168|NCT02668211|"     MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of     its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows     precise measurement of micromotion around orthopedic implants and hence, may estimate     long-term fixation to bone.   "
47169|NCT02668198|"     The purpose of this study is to compare the accuracy of using different endoscopic imaging     technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near     focus) for detection of residual neoplastic tissue at site of prior EMR   "
47170|NCT02668185|"     Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational     product   "
47171|NCT02668172|"     The objective of this study is to assess the efficacy of Pasireotide Long Acting Release     (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients     previously controlled with combination treatment of long-acting Somatostatin analogs     (LA-SSAs) and PEGV.   "
47172|NCT02668159|"     The overall goal of this study is to investigate the effects and the mechanisms of action of     a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic     risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to     study the acute physiological effects of fish nutrients and to discover gene/metabolite     networks that underlie these effects.   "
47173|NCT02668146|"     Obtain information on whether the medication Perampanel reduces tremor in people with     essential tremor and is well-tolerated.   "
47174|NCT02668133|"     Background: Community based-intervention trials conducted among infants and young children in     low- and middle-income countries have found that zinc supplementation of young children (in     the form of liquid supplements or dispersible tablets) increases linear growth and weight     gain, and reduces the prevalence of diarrhea and respiratory infections, and lowers all-cause     mortality. Aside from supplements, additional dietary zinc can also be provided through     home-fortification of complementary foods with small-quantity lipid-based nutrient     supplements (SQ-LNS; 20g/d), which are typically formulated as a peanut-based paste enriched     with a vitamin and mineral complex containing 8 mg elemental zinc (as ZnSO4). However, the     efficacy of LNS as a delivery vehicle for preventive zinc supplementation remains uncertain.     Two recent studies, which provided LNS containing 4-10 mg Zn daily for 6-9 months found no     significant differences in plasma zinc concentrations at the end of the intervention period     compared to placebo.      This lack of response may be due to the reduced absorption of zinc when it is part of a     complex food matrix and provided with cereal-based meals; both SQ-LNS and cereal grains     contain moderate to high concentrations of phytate, the main dietary factor known to     substantially reduce zinc absorption. The addition of exogenous phytases is an efficacious     strategy to reduce the phytate content of foods, and increase the bioavailability of dietary     zinc; however, the efficacy of this approach has not yet been demonstrated for SQ-LNS.      Objective: The overall objective of the study is to assess the efficacy of adding exogenous     phytase to SQ-LNS by investigating intra-individual differences in the fractional absorption     of zinc (FAZ) among children who receive additional dietary zinc (8 mg/d) from SQ-LNS with or     without phytase.      Trial approach: The study will be a double-blind randomized controlled clinical trial,     designed to permit within-child comparisons of zinc absorption from SQ-LNS, with or without     exogenous phytase, by using the triple stable-isotope ratio tracer technique. The clinical     study will enroll 34 children between the ages of 18-23 months. The main outcome of interest     is the intra-individual difference in the FAZ from porridge-based meals containing SQ-LNS     with and without phytase. Up to an` additional 36 children will be enrolled in a pilot     feeding study to determine portion sizes of study meals.      Trial setting: Keneba, The Gambia      Trial interventions:      The SQ-LNS (20g) used in this study will be provided by Nutriset, S.A.S. The exogenous     phytase (DSM phytase Tolerase 20000G) is derived from Aspergillus niger; phytase will be     added to the SQ-LNS during the production phase, and will be enzymatically active in vivo at     the time of consumption.      Feeding Protocol and Study Diet: The study diet for the 2day absorption study will consist of     the following: 1) Two stable-isotope labeled test meals per day (porridge made from locally     procured non-fermented cereal, mixed with 10 g of SQ-LNS), with children randomized to     receive either SQ-LNS with phytase or SQ-LNS without phytase on the first day and the     alternative product on the second; 2) One additional standardized meal per day (e.g. rice     with sauce); 3) Low-zinc, low-phytate food (e.g. bananas) consumed ad libitum if requested     (with the exception of 1 hour before and 2 hours after each test meal). Children will be fed     by their caregivers under supervision by a study fieldworker. The SQ-LNS product (without     phytase) will be provided to children twice per day for one day prior to the start of the     stable isotope absorption studies, in order to habituate children to the study diet and     location. Children will attend the study clinic daily for four days and will be enrolled in     the study for a total of ten days.      Zinc absorption studies: The FAZ of zinc will be measured by a triple-isotope tracer ratio     technique, using orally administered extrinsic labels (Zn-67 and Zn-70) and intravenous     Zn-68. Urine samples, collected pre- and post-isotope administration (d 1, 5-9) will be     analyzed for zinc isotope ratios by ICP-MS. FAZ will be calculated based on the mean isotopic     ratios obtained from the enriched urine samples, and based on the tracer:tracee ratio method.     TAZ will be calculated by multiplying FAZ by total zinc intake from the test meals.      Data Collection: The following information will be collected from each subject: brief medical     history; physical examination; weight and height; daily morbidity and pre-intervention blood     sampling for hemoglobin, complete blood count and plasma zinc concentration, malaria and     systemic inflammation (C-reactive protein and α-1-acid glycoprotein).   "
47538|NCT02663375|"     Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery     System implantation in patients presenting severe symptomatic aortic stenosis to collect     continued surveillance data pertaining to safety and performance of the device.   "
47175|NCT02668120|"     Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor     perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was     suspected in patients affected by chronic histiocytic intervillositis. This increase may     correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in     this pathology.      Aim : To confirm the association between high levels of alkaline phosphatase and the     occurrence of chronic histiocytic intervillositis.   "
47176|NCT02668107|"     To compare and analyze the effects on the electromyographic activity of preterm newborns     placed in the hammock position with the activity of newborns not placed in this position.   "
47177|NCT02668094|"     Pain is a common side effect of propofol injection. The purpose of this study was to compare     the efficacy of pregabalin and lidocaine in reducing propofol injection pain.   "
47241|NCT02667262|"     The purpose of this study is to develop and validate a classification model based entirely on     medical claims data that can be used to identify patients experiencing prescription opioid     abuse/addiction among patients receiving extended-release (ER) and/or long-acting (LA)     opioids   "
47179|NCT02668068|"     Pneumoconiosis is a kind of lung disease due to inhalation of dust such as silica(common     named Silicosis), coal and rock dust, characterized by inflammation, coughing, and fibrosis.     Currently there is no effective drug treatment. The whole-lung lavage(WLL) can effectively     clear the protein-like substances and inhaled dust deposited in the alveoli and bronchioles,     as well as the pulmonary alveolar macrophage(PAM) and the resulting induced inflammation,     fibrosis induced factor, serve to improve respiratory function, relieve symptoms of efficacy,     but can't slow down or reverse the progression of pulmonary fibrosis.      By taking large volume whole-lung lavage (WLL) as a conventional therapy, this study intends     to observe and evaluate the safety and efficiency of combined large volume WLL with     mesenchymal stem cell (MSC) transplantation for treatment of Pneumoconiosis. Moreover, the     immune regulation effect between large volume WLL and combined large volume WLL with MSC     transplantation will also be preliminarily investigated and discussed.   "
47180|NCT02668055|"     Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes     the effectiveness of clinical trials for the treatment of difficult to heal wounds and     security.   "
47181|NCT02668042|"     The main purpose of this experiment was to evaluate the activity of tissue engineering skin     substitutes safety and efficacy studies for the treatment of difficult to heal wounds   "
47182|NCT02668029|"     Patients with pulmonary fibrosis often desaturate on exercise. There are no data showing     whether ambulatory oxygen can be useful to improve exercise capacity in this condition.     Ambulatory ambulatory oxygen is often denied to these patients based on studies conducted on     patients with chronic obstructive pulmonary disease, a completely different condition for     physiopathology, prognosis, and response to therapy. We therefore planned a controlled study     to verify the usefulness of ambulatory oxygen in patients with pulmonary fibrosis   "
47183|NCT02668016|"     Front-line clinicians cannot currently test for an individual participant whether symptoms     experienced are the pharmacological result of a statin or due to other phenomena. In this     trial, participants who have previously ceased statins due to side effects will be offered     the opportunity to undergo twelve randomly ordered 1-month periods. There will be four     periods of no medication, four periods of placebo and four periods of statin. The placebo and     the statin pills will be identical in appearance. Participants will record on a daily basis     side-effects experienced. At the end of the study, the one-month sessions are sorted into the     order shown above. The participant can then observe directly how much of the increase in     symptoms seen with statin is also seen with placebo.        1. Hypothesis 1: that >30% of participants enrolling for the study will complete it.        2. Hypothesis 2: Overall >50% of symptom burden is nocebo rather than pharmacological        3. The investigators will define the Nocebo proportion of side effects.        4. Hypothesis 3: that the majority of participants, at 6 months after completion, will          either be taking statins or have declined statins for reasons other than perceived side          effects.   "
47184|NCT02668003|"     It is known from many studies that when patients have developed chronic widespread pain (CWP)     or fibromyalgia that managing such symptoms is extremely challenging for both doctors and     patients. The investigators have shown in a recently completed study funded by Arthritis     Research UK that a course of Cognitive Behaviour Therapy delivered by telephone (tCBT) or an     exercise regime can substantially improve the chances of the symptoms improving. The     investigators now plan to offer this therapy to patients who are at a high risk of developing     CWP (but who have not developed it yet) to see whether its onset can be prevented.   "
47185|NCT02667990|"     22 women Testing orthopedic stilettos compared to standard stilettos and a comfy trainer.      Testing involves pedobar pressures and a validated comfort questionnaire.   "
47186|NCT02667977|"     The study aim is to isolate a single type of patient (pediatric patient with acute     gastrointestinal symptoms) and evaluate the use of hypotonic (0.45 NS) vs. isotonic (0.9 NS)     fluids in these patients in regards to changes in their serum sodium and iatrogenic     hyponatremia.   "
47187|NCT02667964|"     FGF-21 and insulin are key hormones in the regulation of glucose metabolism. Furthermore,     both hormones are influenced by physical activity. The following hypothesis will be tested:     FGF-21 is regulated insulin-dependent during exercise.   "
47188|NCT02667951|"     The illness course and symptoms of dementia is usually very long and characterized with     behavioral, psychological and physical changes. Family caregivers' stresses change during the     illness trajectory as well. The purpose of this study is to compare the costs and     effectiveness of two care models- home-based caregiver-training program model and routine     care model for dementia elders in Taiwan.   "
47189|NCT02667938|"     The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in     patients with Benign Prostatic Hyperplasia and Erectile Dysfunction   "
47203|NCT02667756|"     This observational study seeks to identify and validate novel soluble biomarkers (within     blood, synovial fluid, urine) which contribute to the prognostic assessment of an individual     with an acute knee injury, a group of individuals in which ~50% will progress to symptomatic     radiographic knee osteoarthritis (OA).      150 individuals will be followed over 5 years with clinical assessment including validated     questionnaires, biological sampling and radiological imaging (X ray, magnetic resonance     imaging (MRI)).   "
47190|NCT02667925|"     The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on     platinum salt and surgery whose quality is the major prognostic factor.      A meta-analysis of retrospective series had shown that for every 10% increase in the complete     cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001).     Currently, it is recognized that the best chance of survival conferred to patients whose     initial surgical residue is zero (Harter et al, 2009).      However, even if macroscopically complete surgery and whatever the type of systemic     chemotherapy, peritoneal recurrence remains high for more than 75%.      To reducing it of recurrence, a therapeutic approach is to administer chemotherapy     intraperitoneally.      The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal     cavity.      Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of     an intraperitoneal chemotherapy according to this method with a conventional systemic     chemotherapy. Alberts reported a significant improvement in the median overall survival.     Armstrong shows in addition a decreased risk of recurrence.      It must be remembered that:        -  The establishment of an intra-abdominal catheter does not always ensure complete flow of          drugs into the peritoneal cavity (major postoperative adhesions).        -  There may be problems of catheters becoming blocked and requiring local treatment; these          problems can cause abdominal pain whose care is difficult. Thus almost half of patients          fail to get all six courses of intraperitoneal chemotherapy.      Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP     peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that     the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy     within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003,     Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal     pain sites described by the patient as well as peritoneal recurrence sites found during     monitoring.   "
47191|NCT02667912|"     Objective of this study is to evaluate whether a distal mode of endovascular renal     denervation with the treatment performed primarily in segmental branches of renal artery is     more effective than conventional mode of the intervention with the treatment equally     distributed within its main trunk for the treatment of drug-resistant hypertension.   "
47193|NCT02667886|"     The purpose of the study is to test different doses of X4P-001 given alone and in combination     with axitinib in patients diagnosed with advanced renal cell carcinoma. The goals of the     study are to determine the safety and tolerability of X4P-001, as well as the potential     effect it may have on the body and the cancer tumor.   "
47194|NCT02667873|"     Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of     orally administered SL-801 in patients with Advanced Solid Tumors   "
47195|NCT02667860|"     The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as     superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic     results, analgesia requirements and length of hospital stay. The objective of this study is     to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in     patients undergoing laparoscopic right hemicolectomy.   "
47196|NCT02667847|"     Preoperative anxiety is a complex clinical concept with both physiological and psychological     consequences.   "
47197|NCT02667834|"     Social cognition and interaction training (SCIT), a group-based treatment that aims to     improve both processing social information and functioning, may be an effective treatment for     enhancing the social skills of people with schizophrenia. This study will compare the     effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual     (ETP) in helping people with schizophrenia improve their social cognition and social     functioning so specially on negative symptoms. Many studies show a connection between     negative symptom and social cognition in schizophrenia.   "
47198|NCT02667821|"     The Investigators are performing a study to determine, in patients with chronic/recurrent     neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements,     including manipulation, in vivo using fMRI technology on vertebral and cranial blood flow     dynamics affecting brain perfusion, and extend the current data set on these variables   "
47199|NCT02667808|"     The aim of this study is to identify reproductive health priorities among individuals living     with HIV.This study also seeks to explore factors that influence fertility, family planning,     and sexual behavior among individuals with HIV who are receiving antiretroviral therapy     (ART).   "
47200|NCT02667795|"     It is generally accepted that physically fit patients cope much better with the stress of     surgery and recover faster. Consequently several research studies have tried to increase     people's level of fitness before they have surgery. These previous research studies have     usually required patients to carry out intense, structured exercise programmes that involve     going to a gym. However such programmes are not 'user friendly' especially if people are not     used to taking a lot of exercise. In this pilot study we want to test the feasibility of a     home based programme that tries to increase patients' level of fitness by gradually     increasing the number of steps they walk every day.      Participants will be randomised into one of two groups. One group of participants will be     asked to increase their level of activity by gradually walking further (the exercise group)     and the other group will carry on with their usual level of activity (the usual activity     group) .      Assessments People in both groups will have an assessment on 3 occasions: when they join the     study, just before surgery and 3 months after surgery.      This assessment involves:      Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for     some information about their medical history Completing three questionnaires about how they     are feeling and their quality of life.      People who are randomised to the exercise group will be advised about how many steps to take     based on how they did in the initial walking assessment. The number of days or weeks they     will be asked to take a daily walk will depend on how much time there is between them joining     the study and the date of their surgery. We think this will be about 2 weeks.   "
47201|NCT02667782|"     The aim of this study is to examine which mindfulness-based intervention protocol, MBCT or     MBSR, is more suited for use among local carers of people with dementia (PWD), as measured by     better mental health outcomes in PWD such as reductions in stress and improvements in mental     well-being.   "
47202|NCT02667769|"     This is a prospective study with a crossover design, where fasting with a day of complete     fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods     are compared in a randomized order. Underlying hypothesis is that at the same basal insulin     substitution with the fasting of both protocols , no significant differences in the     glucose-day or -night profiles revealed. So the same conclusions regarding the consistency     of basal insulin dosing revealed during the implementation of the part of patients is rated     as more pleasant when calories and carbohydrates-free food are allowed.   "
47539|NCT02663362|"     The purpose of this study is to develop and refine the techniques for using magnetic     resonance imaging and magnetic resonance spectroscopy to understand the composition and     function of the human body   "
47204|NCT02667743|"     An open-label randomized and controlled clinical trial: This study was to compare the     anticancer efficacy and safety in the First-Line Treatment in patients with Advanced     Non-Small-Cell Lung Cancer with Paclitaxel Micelles for Injection In combination with     Cisplatin versus Paclitaxel Injection Containing Cremophor EL(polyoxyethylenated castor oil)     In combination with Cisplatin in the way of an open-label, randomized controlled clinical     trial.      Treatment Protocol:      The subjects were randomized in the Paclitaxel Micelles for Injection Group and the     Paclitaxel Injection Group by the proportion of 2:1. The centralized randomization method was     adopted in this trial. Since the study was a comparison of first-line treatment, the test for     superiority was adopted. The objective response rate was the primary indicator of efficacy in     this study.      Trial Group:      Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks     constituted one course of treatment.      No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required     for the patients before infusion of Paclitaxel Micelles for Injection patients.      Control Group:      Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks     constituted one course of treatment.      Standard preventive treatment must be given to patients in accordance with the specific     requirements in specifications of Paclitaxel Injection.      Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper     limit.      To estimate the sample size based on objective remission indicators (CR + PR) in the study.     Hypothesis: the objective remission rate of the Paclitaxel Micelles for Injection combined     with Cisplatin in the Trial Group is different with that of first-line treatment of advanced     non-small cell lung cancer, and is also different with that of the Cremophor EL-containing     Paclitaxel Injection combined with Cisplatin in the Control Group. Trial parameter settings:     assuming α = 0.05 and 1-β = 80%, the Trial Group: Control Group is designed as per the     proportion of 2: 1. According to the sample size formula , a total of 426 patients is     required, including 284 patients assigned in the Trial Group and 142 in the Control Group. In     consideration of case expulsion in the process of clinical, enlarged by 10%, actually 468     cases were included in the groups, including 312 in the Trial Group and 156 in the Control     Group.   "
47205|NCT02667730|"     In this 4-arm pragmatic randomized control trial, the investigators hope to decipher whether     the use of non-opioid analgesics (naproxen, celecoxib, acetaminophen) in addition to     standardized physiotherapy during the acute phase of grade I-II ankle injuries will result in     functional differences compared to standardized physiotherapy alone   "
47206|NCT02667717|"     AlgoMIR project born thanks to a meeting between pain professionals and re-education staff.     The goal of this project is to develop and evaluate a program of learning with exercises by     mirror therapy, that could be easily shared with paramedic teams and easily adapted to     different handicaps.      Researchers have chosen to select patients with re-education of the upper extremity to     benefit from rehabilitation sessions either from physiotherapists present in their city, or     of functional rehabilitation hospital units.   "
47207|NCT02667704|"     The trial was designed to investigate whether, and to which extent, multiple doses of     bosentan may influence the plasma levels of nintedanib administered as a single dose.   "
47208|NCT02667691|"     The objective of this study is to evaluate the influence of a 3 months SODB® supplementation     in adipose tissue modulations of overweight women, in comparison to a placebo.   "
47209|NCT02667678|"     The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for     patients infected by HIV with failure in renal function at year 5. The main criterion will be     a degradation of the glomerular filtration throughput measured. It will be compared to     clinical scores of degradation risks of renal function for patients infected with HIV.   "
47210|NCT02667665|"     Examine the construct validity, the test-retest reliability, the concurrent validity with the     standard dementia rating scales and the reactivity of a novel dementia rating scale QuQu     scale: QUick QUestion scale final for the evaluation of patients with Alzheimer's Disease     Dementia and Mild Cognitive Impairment.   "
47211|NCT02667652|"     The purpose of this study is to investigate the curative effect of the length of the jejunum     exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and     reasonable operation parameters.   "
47212|NCT02667639|"     The purpose of this fist in human study is to evaluate the safety and tolerability of RPH-104     in humans.   "
47213|NCT02667626|"     The investigators propose to test the efficacy of the Reproductive Health Survivorship Care     Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young     breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy,     treatments that impair ovarian function and result in significant reproductive health late     effects. These late effects include symptoms of estrogen deprivation such as hot flashes,     fertility concerns, limited contraception options and sexual problems. Together they have a     major, negative impact on quality of life.      Despite substantial research, treatment guidelines and clinical expertise on these issues,     most YBCS and their healthcare providers have limited guidance on how best to manage these     reproductive health late effects. The research team has generated a practical, accessible,     evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their     providers to address this deficit in survivorship care. This clinical trial will test if YBCS     who receive the web-based SCP-R are more likely than controls to improve on at least one of     these reproductive health issues: hot flashes, sexual health, fertility concerns, and     contraception.   "
47214|NCT02667613|"     Studying in a RCT the changes in everyday llife activities of children with CP during     HABIT-ILE or control period, changes being scored by parents and by experts.   "
47215|NCT02667600|"     The aim of this study is to assess the ability of the Triton Device to measure blood loss     among women undergoing elective and non-elective cesarean delivery. This patient population     often experiences significant blood loss during surgery, and measurements of surgical blood     loss are often inaccurate.   "
47216|NCT02667587|"     The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated     (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus     radiation therapy. They will be compared to patients receiving Nivolumab in addition to     temozolomide plus radiation therapy.   "
47217|NCT02667574|"     Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with     locally advanced BCC.   "
47218|NCT02667561|"     This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics     and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days   "
47219|NCT02667548|"     Coronary heart disease (CHD) has a serious health threaten to population. PCI is a     well-proved measure in CHD management. However, the knowledge about the real-life PCI use and     how evidence-based therapies in routine clinical practice is limited. By consecutively     recruiting PCI patients in a large-scale hospital in in Northeast China,this study will     examine various real-life factors, that may affect patients recovery after the procedure.     Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be     established based on the findings, to improve patients outcomes in future finally.   "
47602|NCT02662543|"     This study is designed to estimate the changes in the etiology and epidemiology of acute     gastroenteritis in children aged less than 18 years after the implementation of rotavirus     vaccine in the Estonian national immunization program in July 2014.   "
47222|NCT02667509|"     Myopia has emerged as a major health issue in east Asia, because of its increasingly high     prevalence in the past few decades (now 80-90% in school-leavers), and because of the     sight-threatening pathologies associated with high myopia, which now aff ects 10-20% of those     completing secondary schooling in this part of the world. Similar, but less marked, changes     are occurring in other parts of the world. The higher prevalence of myopia in east Asian     cities seems to be associated with increasing educational pressures, combined with life-style     changes, which have reduced the time children spend outside.   "
47432|NCT02664766|"     The purpose of this research is to examine the effects of long-term aerobic exercise of     moderate intensity on psychological, physiological, biochemical, physiological and     alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical     mechanisms by which exercise may be a healthy alternative to alcohol abuse.   "
47223|NCT02667496|"     Primary Objective:      To compare the effect of repeat doses of Leukine to placebo administered subcutaneously (SC)     on established cortical amyloid load in patients with mild cognitive impairment (MCI) due to     Alzheimer's disease (AD).      Secondary Objective:        -  To evaluate safety and tolerability of Leukine versus placebo.        -  To explore the effect of Leukine versus placebo on cognitive performance.        -  To collect biospecimens for future biomarker research.   "
47224|NCT02667483|"     This is a phase I/II study to evaluate the safety, tolerability, efficacy, and     pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD)     amenable to exon 45 skipping and to determine the dosage for subsequent studies.   "
47225|NCT02667470|"     The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score     (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate     correlation between change of OABSS scores and other measures for OAB symptoms.   "
47226|NCT02667457|"     The study is being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to     image atherosclerotic plaque that may rupture and break off artery walls. This is caused by     apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in     the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up on     any artery in the body.   "
47227|NCT02667444|"     This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel     group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.   "
47228|NCT02667431|"     Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical     health and decrease costs for both patients and the health care system. At the time of     endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a     gynecologic oncologist, but the majority will undergo surgery within weeks of their     diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and     concurrent surgery performed. This would spare the patient two surgeries, decrease the     emotional distress associated with SUI symptoms, decrease the costs associated with SUI for     the patient and possibly improve overall quality of life. The proposed study will compare the     quality of life and clinical outcomes among women with endometrial cancer and SUI that have     concurrent surgery to women that do not have concurrent surgery. The findings of our proposed     research will provide valuable information necessary for woman and clinicians to make     decisions regarding the treatment of SUI, including evidence regarding the risks and benefits     of performing concurrent endometrial cancer and SUI surgery.   "
47229|NCT02667418|"     The purpose of this study is to determine whether fidaxomicin and vancomycin followed by     taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the     treatment of recurrent Clostridium difficile infection.   "
47230|NCT02667405|"     This study investigates the effect of hot packs versus whirlpool and exercise for patients     with distal radius fracture (DRF). Patients with recently healed DRF are randomized into two     groups, with one group receiving hot packs during therapy and the other immersing the arm in     a whirlpool for 3 consecutive therapy visits. The effect of these modalities on range of     motion and volume of the hand are evaluated, with measurements taking place before and     immediately after heat during each visit.   "
47231|NCT02667392|"     Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an     estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88     million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability     contributes to these costs. To walk again is the number one stated goal for Veterans who     have had a stroke. Teaching patients post-stroke to use their weak leg while they are     regaining walking function and to not compensate by over-using their strong leg is necessary     to restore safe, efficient walking ability. This project will determine if providing     biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage use     of the weaker leg during walking training, in addition to therapists' feedback, will help     Veterans regain use of their weak leg, improve their endurance and improve their balance when     walking in challenging environments.   "
47232|NCT02667379|"     Determination of allergenicity of cat dander samples obtained before and after vaccinating     the cat   "
47233|NCT02667366|"     The aim of the study is the examination of effectiveness and cost-effectiveness of a     telephone-based psychotherapy (Tel-PT) for depression compared to treatment as usual in     primary care.   "
47234|NCT02667353|"     To study the potential neurorestorative effects of electroconvulsive therapy (ECT) in     depressed patients by measuring brain derived neurotrophic factor (BDNF) serum levels and     hippocampal volumes in severely depressed patients receiving ECT.   "
47235|NCT02667340|"     To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made     byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of     specific soccer skills, and on cognitive function during and following a simulated soccer     game.      Secondary: To compare fat oxidation and carbohydrate oxidation (based on RER data) during the     game with Generation UCAN vs isoenergetic placebo (glucose).   "
47236|NCT02667327|"     The purpose of this study is to determine whether Granexin gel is safe and effective in the     treatment of diabetic foot ulcers.   "
48213|NCT02654548|"     To investigate whether women with polycystic ovary syndrome who are post-partum excrete     higher levels of sebum in comparison to healthy controls due to high levels of androgens.   "
47237|NCT02667314|"     Meta-analyses indicate beneficial effects of cognitive training and cognitively challenging     video games on cognition. However, cognitive effects of solving jigsaw puzzles - a popular,     visuospatial cognitive leisure activity - have not been investigated, yet. Thus, the primary     aim of this study is to evaluate the effect of solving jigsaw puzzles on visuospatial     cognition. As secondary aims, effects on psychological outcomes (self-efficacy, perceived     stress, well-being) and visuospatial everyday functioning (instrumental activities of daily     living and self-reported cognitive failures in everyday life) are examined.   "
47238|NCT02667301|"     The purpose of the study is to understand the exact mechanism of the activity of paratubal     muscles in opening eustachian tube in patients with the functional eustachian tube and those     with the eustachian tube dysfunction problem.   "
47239|NCT02667288|"     This is an open-label safety study. During this study, the investigator will identify 4     eligible SK Target Lesions on each subject on the trunk, extremities and face.   "
47240|NCT02667275|"     This is a randomized, double-blind, vehicle-controlled, parallel group study.   "
47242|NCT02667249|"     Compliance to the clinical pathway, postoperative complication and total cost of the     hospitalisation of patients undergoing elective cholecystectomy for symptomatic     cholecystolithiasis were collected over two different periods: using a clinical pathway in     form of a paper based check-list (group 1, n=118) or a clinical pathway integrated into the     paper based medical treatment and nursing documentation (group 2, n=123). Outcome measures     were compliance of the clinical pathway and total costs per case.   "
47243|NCT02667236|"     This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101     Solution 40% compared with Vehicle Solution.   "
47244|NCT02667223|"     This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and     hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single     subcutaneous injection. Subjects will remain confined at the research clinic for     approximately 2 days. After discharge, subjects will return to the research clinic 15 times     during 12 weeks.   "
47245|NCT02667210|"     To assess whether the percentage of patients with behaviors suggestive of misuse, diversion,     abuse and/or addiction described in the medical record increases across pre-defined     categories of increasing doctor/pharmacy shopping behavior.   "
47246|NCT02667197|"     The purpose of this study is to determine reliability of codes and data from electronic     medical records to predict and measure overdose and death in patients prescribed opioid     analgesics. The study will compare this electronic data to data manually obtained from     medical charts.   "
47247|NCT02667184|"     The goal of this study is to determine subjective gastrointestinal tolerance response and     differences in breath hydrogen response following the consumption of different types of low     FODMAP oral nutrition supplements. This randomized, crossover study requires participants to     arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete     gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen     analysis at various time points over a 4 hour time period.   "
47248|NCT02667171|"     International and national publications emphasize that COPD rehabilitation is a key     cornerstone in the standard treatment of COPD, based on more than 15 years of research in     COPD rehabilitation. COPD rehabilitation improves quality of life, anxiety and depression and     physical function. COPD rehabilitation including special physical training, patient-directed     education and smoking cessation is core rehabilitation elements, which today are recommended     as mandatory content in standard COPD rehabilitation.      Standard COPD rehabilitation is an established offer in all regions and municipalities in     Denmark. It is however a well-known challenge, that persons with the most severe COPD     symptoms and co-morbidities are most likely not to receive COPD rehabilitation. Frequent     exacerbations, socially isolation, transport distance to rehabilitation are main reasons why     people with severe COPD disease deliberately chooses not to receive COPD rehabilitation. Why     there at present are no rehabilitation alternatives for patients with the most severe COPD     symptoms, supervised COPD Online rehabilitation in groups, delivered by health professionals     in the COPD patients' own home via a computer screen could likely encourage more people to     participate. The number of RCT's investigating the effect of supervised Online delivered COPD     rehabilitation in groups versus established COPD rehabilitation are very limited.      The purpose of this randomized study is to investigate the short-term and long-term efficacy     of 10 weeks of online COPD rehabilitation versus conventional supervised COPD rehabilitation     in people with severe and very severe COPD. The outcome of the intervention is measured on     walking distance, muscle endurance, activity level, quality of life and COPD symptoms     respectively. Outcomes are measures before intervention start, end of intervention. This     study also collects follow-up update after 3, 6 and 12 month. The follow-up data will be in     separate publication.      Hypothesis        1. COPD online rehabilitation provides significant larger improvements than the usual care          on walking distance, muscle endurance, activity level, and quality of life and COPD          symptoms in people with severe and very severe COPD.        2. COPD online rehabilitation and conventional COPD rehabilitation, provides clinically          relevant improvement on walking distance, muscle endurance, activity level, quality of          life and COPD symptoms in people with severe and very severe COPD.   "
47249|NCT02667158|"     To evaluate the reasons patients go to more than one prescriber or more than one pharmacy to     obtain prescriptions opioids and assess whether the percentage of patients reporting misuse,     abuse and/or diversion increases across defined categories of doctor/pharmacy shopping as     defined in Study 4A.   "
47250|NCT02667145|"     Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care     program using assistive technology for treatment of hand osteoarthritis.   "
47251|NCT02667132|"     The aim of this study was to retrospectively review the granulomatous mastitis and evaluated     current approach and treatment.      HYPOTHESIS Although there is no common protocol for the treatment and management process of     GM, the ternary treatment (medical treatment following by surgical procedure,     Steroid+Antibiotic and surgical procedure, respectively) is considered as the most successful     treatment approach.   "
47252|NCT02667119|"     The purpose of the study is to determine the safety and efficacy of an integrated treatment     for substance abuse and posttraumatic stress disorder for young adults. The integrated     treatment includes two established psychosocial treatments for substance abuse (Contingency     Management) and posttraumatic stress disorder (Prolonged Exposure therapy).   "
47253|NCT02667106|"     This Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute,     topical, intranasal administration to healthy male and female volunteers.   "
47254|NCT02667093|"     The purpose of this project is to develop a process to identify highly personalized antigens     that are uniquely expressed by the patient's own leukemia cells that can be used for cellular     immune therapy.   "
47255|NCT02667080|"     The main purpose of the study is to assess to which degree a series of sperm parameters known     to be associated with fertilization and implantation potential in artificial reproductive     technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of     sexual abstinence in males from couples referring for ART treatment.   "
47256|NCT02667067|"     This study is intended to demonstrate that the Simplify® Disc is at least as safe and     effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat     one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as     intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain     or myelopathy due to a single-level abnormality localized to the level of the disc space in     subjects who are unresponsive to conservative management.   "
47257|NCT02667054|"     To determine if RX0041-002 is a safe and effective topical anesthetic.   "
47265|NCT02666950|"     This randomized phase II trial studies how well WEE1 inhibitor AZD1775 with or without     cytarabine works in treating patients with acute myeloid leukemia or myelodysplastic syndrome     that has spread to other places in the body and usually cannot be cured or controlled with     treatment. WEE1 inhibitor AZD1775 may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether giving     WEE1 inhibitor AZD1775 works better with or without cytarabine in treating patients with     advanced acute myeloid leukemia or myelodysplastic syndrome.   "
47258|NCT02667041|"     Major depressive disorder (MDD) is a debilitating illness that affects millions of     individuals in North America and can result in clinical symptoms including loss of pleasure     and feelings of worthlessness, in addition to significant cognitive impairments (e.g.,     memory, attention) that affect daily functioning. Major depression bears a heavy burden for     the individuals and family members afflicted, as well as an enormous health care and economic     cost. Approximately half of major depressive patients seek out treatment for their illness     and only 20% of those individuals report their treatment as satisfactory. Many MDD patients     do not respond to pharmacological therapy following the first course of treatment, resulting     in the need for alternative measures to alleviate the clinical and cognitive symptoms of     treatment-resistant depression and the targeting of these therapies to better suit each     individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a well-accepted,     non-invasive technique that utilizes currents to induce electrical fields that excite     specific brain regions. The current recommended practice of rTMS involves the administration     of a biphasic stimulus waveform; however, a novel method using monophasic pulses may prove     more effective for the treatment of depression. The present study aims to determine the     effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in MDD patients     through electrophysiological recordings of the brain taken before and after 6 weeks of     stimulation. Additionally, the study aims to investigate various biological markers linked to     clinical rTMS response; these brain markers will help in personalizing treatment for     individuals suffering from MDD.   "
47259|NCT02667028|"     Coronary heart disease (CHD) has a serious health threaten to population. PCI is a     well-proved measure in CHD management. However, the knowledge about the real-life PCI use and     how evidence-based therapies in routine clinical practice is limited. In a large-scale     hospital in Northeast China, the investigators will examine various factors of 3007     consecutive PCI inpatient cases from January 1, 2010 to October 31, 2014. The medical records     will be reviewed and abstracted to evaluate the clinical treatment pattern and outcomes.     Basic data and innovative evidence will accelerate evidence-based clinical practice, and     improve patients' outcomes in future finally.   "
47260|NCT02667015|"     The aim of the current study is to develop and pilot test an anxiety sensitivity-based     intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions     include determining whether a broadly-applicable AS-based intervention can significantly     decrease both substance misuse and anxiety. Secondary aims include examining the impact of     this intervention on general functioning and depressive/anxious symptoms. In phase I, an     initial pilot was conducted to examine the feasibility, safety, and patient satisfaction with     the protocol, and to estimate potential efficacy of the protocol. In phase II, participants     will be randomized to the intervention or a control condition.   "
47261|NCT02667002|"     Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to     random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform     and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene     mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane     (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of     nullipara patients. Investigators will investigate which technique keep the vaginal axis is     closer to the original anatomic position.   "
47262|NCT02666989|"     Open label placebo treatment has been tried for irritable bowel syndrome (Kaptchuk et al,     2010), where three weeks of open label placebo proved superior to a wait-listed control     group. Another pilot study demonstrated efficacy in treating children suffering from ADHD     with open label placebo treatment (Sandler & Bodfish, 2007). Recent work has shown that     placebo openly given can have significant analgesic effects for acute migraines (Kam-Hansen     et al, 2014) and for experimentally-induced pain (Schafer at al, 2015). A preliminary attempt     to treat depression with open label placebo proved the feasibility of such a study, but was     too small and brief for conclusive results (Kelley et al, 2012).      We provide here the protocol for a study to assess the effect of open label placebo treatment     for depression.   "
47263|NCT02666976|"     Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump     inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is     to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus     of symptom score, histopathologic findings and inflammatory biomarker.      A prospective study performed at single hospital enrolled 20 patients who were diagnosed     clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal     impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once     daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after     treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary     elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T     lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be     accessed.   "
47264|NCT02666963|"     This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901     following escalating single and multiple oral doses of RTA 901 in healthy adult subjects.      This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD)     and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be     conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of     up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901 or     placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4     will be assessed in each group prior to dose escalation.      Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3     groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio to     receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and     available pharmacokinetics through Day 17 will be assessed in each dosing group prior to dose     escalation.   "
47266|NCT02666937|"     A prospective study in the ICU in a university hospital in Amsterdam. The relationship     between the oxygen saturation measured by pulse-oximetry and the arterial PaO2 is     investigated in the general ICU population in order to investigate which transcutaneous     saturation values are safe.   "
47433|NCT02664753|"     The primary objective of this study is to compare 28 day mortality rates between septic shock     patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy)     versus a similar group of patients not receiving L-Carnitine adjunct therapy.   "
47267|NCT02666924|"     This study aims to determine whether providing language and culturally appropriate cooking     classes to Chinese Canadian individuals with diabetes will help to improve their diabetes     control, knowledge and self care activities. The control group will receive current standard     care of two diabetes education classes led by the dietitian and nurse. The intervention group     will receive standard care and a series of four interactive cooking classes led by a     dietitian, nurse and chef. We will compare the results of blood work, knowledge and self care     questionnaires between the two groups to determine whether there are any benefits to     attending these cooking classes.   "
47268|NCT02666911|"     Investigators will recruit 20 healthy volunteers between the ages of 18 and 80, who have no     history of carpal tunnel syndrome or wrist injury. Images will be captured twice, first with     the 2D transducer and then with the 4D transducer and compared to images captured with the     new 4D transducer, using the same movement data analysis protocols. Investigators will also     assess the inter and intrarater reliability of the 4D transducer images, by using two     different sonographers, both trained in the technique, measuring the same blinded images on     separate occasions, at least two weeks apart. The overall goal of this project is to assess     the reliability, or reproducibility, of measurements in normal subjects using a novel 4D     ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect     motion between SSCT, median nerve and tendon motion for the evaluation and diagnosis of     patients with disorders affecting the carpal tunnel, especially carpal tunnel syndrome (CTS).   "
47269|NCT02666898|"     Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months     /      Study Part 1:      All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days      Study Part 2:      After evaluation at D1 of month 9:      If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at a dose of     420mg daily If patients have BM MRD >10-4 whatever IWCLL 2008 responses or PR they will     receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation     of M16   "
47270|NCT02666885|"     The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the     adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis     the intention is to develop of a multi-parametric decision support system for personalised     medicine by integrating functional imaging, γH2AX-analysis and genetic information.   "
47271|NCT02666872|"     Vaccination greatly reduced mortality and morbidity from many preventable diseases. However,     to avoid the resurgence of these diseases and the human drama associated, high vaccine     coverage should be maintained in the population. Yet in Quebec, vaccine coverage (VC) in     young children remains suboptimal, especially caused by a proportion of parents who are     ambivalent about the safety and effectiveness of vaccines. In this context, the Provincial     Immunization Committee developed in 2010 a Quebec's immunization promotion plan.      Therefore, our research team tested and validated across the Eastern Townships, a vaccination     promotion concept by means of an educational intervention within maternities, based on     motivational interviewing techniques. This intervention has not only significantly increased     the intention of vaccination (+15%) within parents who had received the intervention but also     increased their child vaccination coverage (+7.5% at 7 months). This is the purpose of the     PROMOVAQ study (PROmotion of VAccination in Quebec) This research project evaluated the     impact of an educational strategy based on motivational interviewing techniques within     maternity ward on infants' VC. This strategy has been tested through a provincial study     (Montreal, Quebec, Sherbrooke) including more than 2500 families.      At term, this research program will offer the Quebec's Health Ministry an optimal strategy     for immunization awareness so that Quebec's children may grow healthy and thrive.   "
47272|NCT02666859|"     The proposed project is to develop an effective prosthetic training and rehabilitation     regimen, with the use of virtual reality, to return patients to the highest level of     independence and functioning possible. The Computer Assisted Rehabilitation Environment     (CAREN) system (Motek Medical, Netherlands) will be used to immerse patients into real life     situations while providing real time visual feedback of their motion to improve the training     and rehabilitation of upper limb prosthetic users.   "
47273|NCT02666846|"     This is a randomised, double blind, cross over clinical study in healthy human volunteers     (including pharmacokinetic [PK] sampling and laser Doppler assessment of local blood flow in     a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three     different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s)     in a model of UV-induced inflammatory pain.   "
47836|NCT02659475|"     The goal of this project is to evaluate the effectiveness and tolerability of the novel     weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle     modification counseling in the treatment of binge eating disorder (BED) in overweight or     obese individuals.   "
47274|NCT02666833|"     The purpose of the study is to evaluate the ability and efficacy of using a     polarization-enhanced reflectance and fluorescence imaging device, PERFIS, (see the Device     Brochure) for demarcation of nonmelanoma skin cancer margins prior to surgery. PERFIS is a     harmless and non-invasive device that has been used to image biological tissue both in vitro     and in vivo. In this study it will be used to image nonmelanoma skin cancer lesions prior to     surgery. The use of PERFIS will not affect patient care or treatment decisions in any way. No     extra tissue will be used for imaging.   "
47275|NCT02666820|"     Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been     increasingly accepted as alternative method for removal of large bile duct stones. However,     there were limited studies comparing the efficacy of EST in combined with LBD to EST with     mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of     combined EST- LBD versus EST-ML in the removal of very large bile duct stones.   "
47276|NCT02666807|"     This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear     Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half     will receive placebo.   "
47277|NCT02666794|"     The combined spinal-epidural analgesia during the labor has been associated with changes in     fetal heart rate, which the opinions in literature are not fully consolidated and some     studies have failed to show an increase significant fetal bradycardia following the     combination lock. In addition, it's not clear that these changes found may modify the     perinatal outcome in pregnancies who attend with intrauterine growth restriction (IUGR),     since there are no studies comparing the techniques in this population.   "
49800|NCT02633969|"     The purposes of this study are to evaluate the safety and tolerability and to model the     single-dose pharmacokinetic profile of indomethacin capsules low dose and high dose in     children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.   "
47278|NCT02666781|"     Patients with obstructive sleep apnea (OSA) are more likely to experience postoperative     complications and impact significantly on healthcare resources. In the surgical population,     the type and volume of IV fluid administration may contribute to the worsening of     postoperative sleep apnea but the pathophysiological mechanisms have not been elucidated.     Recent research from general population suggests that intravenous (IV) fluid administration     worsens the severity of OSA by shifting of fluid from the legs to the neck thus increasing     neck size and causing airway collapse. In this novel study, our objective is to examine the     contribution of IV fluid administration and rostral fluid shift from the legs to the neck     thereby leading to worsening of sleep apnea following surgery. In this prospective     observational cohort study, 25 consecutive adult patients, requiring at least 2 days hospital     stay, will be recruited. Following informed consent, patients will undergo portable home     sleep study to determine the preoperative severity of sleep-disordered breathing. On the day     of surgery, leg, neck and total body fluid volumes will be recorded, and patients will     undergo general anesthetic. The results of this study will be used to design future clinical     trials evaluating methods to decrease postoperative OSA worsening, as well as decreasing     OSA-related postoperative complications.   "
47279|NCT02666768|"     This study evaluates the effects of ACTIMMUNE (IFN-γ1b) in children and adults with     intermediate osteoporosis. All participants will receive treatment with ACTIMMUNE for 12     months. The investigators hypothesize that ACTIMMUNE will be tolerated by participants for     the full 12 months and result in decreased disease severity.   "
47280|NCT02666755|"     The purpose of this study is to investigate the sensitivity，specificity and concordance rate     of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by     amplification refractory mutation system(ARMS). Moreover, the investigators correlate our     findings in plasma with survival of advanced patients.   "
47281|NCT02666742|"     The purpose of this study is to learn if taking a drug called Apixaban after an ablation     procedure keeps blood clots from forming and lowers the chance of having a stroke in patients     with ventricular tachycardia (VT).   "
47282|NCT02666729|"     The purpose of this study is to collect information about the success rate of atrial     fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz     ablation catheter.   "
47283|NCT02666716|"     The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to     non-ICU patients. The investigators will determine fluconazole and free fluconazole     concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care.     Switching to oral/enteral fluconazol is allowed after day 3.      A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic     curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken     daily after intravenous therapy.   "
47284|NCT02666703|"     The modern era of cardiac surgery began in early 1950s with the introduction of     cardiopulmonary bypass (CPB). Although it has been clearly shown that CPB is almost     unavoidable for most open heart operations, an undesirable systemic inflammatory response     syndrome (SIRS) is associated with its use. This complex chain of events has strong     similarities with sepsis and may contribute to the development of postoperative complications     and multiple organ failure (MOF). It has been shown that an excessive compensatory     anti-inflammatory response (CARS) after SIRS can lead to immune paralysis and increased rate     of hospital acquired infection. The balance of pro-inflammatory and anti-inflammatory     mediators determines the inflammatory response and the clinical outcome. Accordingly, great     efforts have been focused on therapeutic interventions aimed at reducing the inflammatory     reactions during CPB, including pharmacologic strategies and modification of surgical     techniques or mechanical devices. Such therapies may provide improvements in patient outcome     after open heart operations. Among pharmacologic strategies is the prophylaxis with     corticosteroids, which have been used during open heart surgery for more than 30 years. Many     studies, both experimental and clinical, failed to produce evidence in favor of steroid     treatment. As far as medical devices are concerned, the use of extracorporeal cytokine filter     CytoSorb looks promising in cardiac surgery. It was recently approved by European Medicines     Agency as an active treatment to fight cytokine storm.      Serum paraoxonase 1 (PON1) is a lipo-lactonase, being associated with HDL that has an     anti-inflammatory role and protects against atherosclerosis. Low levels of PON1 are     associated with venous graft occlusion in patients with coronary artery bypass grafting. PON1     reduces monocyte chemotaxis and adhesion to endothelial cells, leading to inhibition of the     differentiation of monocytes into macrophages. The effects of cytokine adsorption therapy on     PON1 are unknown.      The aim of the study is to explore the effects of extracorporeal immunoadsorption during CPB     on pro-inflammatory and anti-inflammatory protective mediators and cellular immune status in     cardiac surgery.   "
47837|NCT02659462|"     prospective cardio respiratory evaluation for patients post the Fontan palliation for single     ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy     volunteers in order to evaluate the functional capacity and the primary etiology for     reduction in functional capacity.   "
47285|NCT02666690|"     RECIST criteria for evaluating tumor response are often inadequate for the evaluation of     anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced     ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response     through the analysis of 7 different parameters. Several studies (four at IGR, involving 117     patients, and a multicenter study involving 400 patients) showed that CEUS allows early     evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly     interesting for the early identification of patients responding (or not) to treatment. Those     are area under curve , and area under the wash-out. To further validate the use of these     parameters, it is essential to measure and describe the level of their intra-patient     variability.   "
47286|NCT02666677|"     This study is an online survey asking for invasive instrumention in trauma patients of an     emergency department   "
47287|NCT02666664|"     The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated     versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is     not adequately controlled by their current therapy.   "
47288|NCT02666651|"     Low blood sodium is a common observation in patients presenting with heart failure and is     associated with increased mortality, prolonged hospital stay, and repeat hospital visits.     Tolvaptan is a new and approved medication to treat low sodium levels in patients who present     with symptoms of heart failure, however, it is not currently available as a treatment option     due to high costs not covered by our provincial plan. In this observational, non-randomized     study the drug will be provided to all subjects free of charge and given only during their     hospital stay. After discharge subjects will be followed for 6 months (3 visits).   "
47382|NCT02665416|"     This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic     activity of RO7009789 in combination with vanucizumab in participants with metastatic solid     tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish     the maximum tolerated dose (MTD) of RO7009789 in this combination. Part II (expansion) is     intended to further characterize the safety and clinical activity profile of RO7009789 among     indication-specific cohorts.   "
47289|NCT02666638|"     The objective of this study is to determine whether these new image acquisition strategies     and techniques using of up to 7T can produce meaningful structural and physiological     information that can serve to improve our understanding of various disease processes in the     clinical setting. 200 Control volunteers will be scanned for approximately one hour, without     contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly     developed imaging software or hardware that conforms to applicable FDA standards and     recommendations. The data (images) for the Control and Experimental Group will be     de-identified by the scan technologist and downloaded to a workstation within the Radiology     Department for offline processing. These images will be reviewed by a trained Radiologist     after the subject has departed.   "
47290|NCT02666625|"     The constitution of a biological samples bank, attached to epidemiological studies Cohort     F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants     that can modulate the iatrogenic risks of these treatments. The main objective is to provide     a biological samples bank to consider, besides the carcinogenic risks, the risk of other     iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and     kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact,     however, is poorly estimated as occurring in adulthood, they are rarely made in relation to     the treatment received in childhood. The overall project is expected to eventually better     define the iatrogenic effects prevention strategies for cancer treatment.   "
47291|NCT02666612|"     Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called     CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly     treated with targeted therapy.   "
47292|NCT02666599|"     The objective of the study is to evaluate the sensibility of the probe Forimtech to detect β+     emission in vivo in humans and its usefulness during elective surgical procedure     Hypothesis:The probe Forimtech is able to allow per-surgery detection of tumoral lesions     sensible to 18F-FDG and to help in the realization of guided biopsies, minimally invasive     surgery or complement of resection of tumors.      The β+ emission detected by the probe Forimtech is correlated to the emission γ detected by     the 18F-FDG.PET/CT   "
47293|NCT02666586|"     To describe the effect and mechanisms of action faba bean powder and fractions (protein,     starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic     regulation in young adults (18 to 30 years).   "
47294|NCT02666573|"     27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this     randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing     pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on     probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to     determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received     subgingival instrumentation and rubber cup polishing with pumice. In addition test sites     received a single application of PDT using Fotosan® and photosensitizer consisting of     toludine blue O solution. The subjects were recalled three and six months later and     re-examined. Site level analysis was performed.   "
47295|NCT02666560|"     To determine the clinical efficacy of auditory cueing using a cross over design to     investigate whether increasing auditory cueing frequency by 20% above self paced cadence     affects gait parameters in children with Cerebral Palsy when performing a functional task.   "
47296|NCT02666547|"     This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of     neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or     18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent     tumor.   "
47297|NCT02666534|"     Surgical excision is the standard treatment for cutaneous SCC. However, many patients     diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser-     assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional     Methylaminolevulinate (MAL)-PDT.   "
47838|NCT02659449|"     The purpose of this study is to determine the impact of compressing therapy on the dexterity     of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board /     Jamar's test)   "
47298|NCT02666521|"     Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency     of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes,     particularly in relation to the clinical use of individual therapies in primary care.      The aim of this study is to provide robust data on the frequency and severity of     hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore     associated risk factors.   "
47299|NCT02666508|"     Dental plaque causes caries and periodontal disease and data are sparse about toothpaste and     plaque removal. Inflammation, caused by dental plaque, is a risk factor for cardiovascular     disease. (CVD) The availability of (Plaque HD (TM), a plaque identifying toothpaste with     targetol technology (TM)), afforded the unique opportunity to test whether there were     statistically significant and clinically important reductions in plaque and inflammation in a     randomized trial of apparently healthy individuals.   "
47300|NCT02666495|"     A reliably effective treatment model for anorexia nervosa is yet to emerge. Recent clinical     trials of psychological therapies over 20-30 sessions, have shown modest benefits. There is     therefore a need to test new treatments to find more effective treatments. Clinical trials of     Schema Therapy have shown low rates of dropout, which is often a problem in the treatment of     anorexia nervosa. Treatment with Schema Therapy, for significantly longer than 20-30     sessions, has been shown to be effective for other complex mental health problems.This pilot     study is therefore designed to pilot the use of individual Schema Therapy for people with     Anorexia Nervosa (iST-AN). This study is a case series pilot study. The study will answer the     principal research question: Does individual Schema mode Therapy, adapted for eating     disorders, have the potential to improve symptoms, quality of life and weight in people with     moderate-severe anorexia nervosa? It will also address secondary research questions: Can     people with moderate-severe anorexia nervosa be recruited to, and kept engaged in, a study of     iST-AN treatment? What is the ideal length of iST-AN treatment? What is the relationship     between self-criticism, body shame, or unhelpful psychological 'modes' and clinical outcome?     Fifteen people with moderate-severe Anorexia Nervosa will be recruited from referrals to a     specialist eating disorders outpatient service. The study will deliver 65 sessions of Schema     Therapy for anorexia nervosa (iST-AN), over a 24 month period, alongside any additional     medical or dietetic management required. Standard outcome measures will be collected at 6     month intervals. The research team have expertise in eating disorders research, schema     therapy for severe anorexia nervosa and are all members of the local clinical service. The     study will take place over a 3 year period.   "
47392|NCT02665286|"     Low back pain is a common cause of visit to emergency department. It is not clear if skeletal     muscle relaxants are of benefit for patients with acute low back pain. This is a randomized     study to determine if skeletal muscle relaxants, when combined with naproxen, improve     outcomes more than naproxen alone   "
47393|NCT02665273|"     This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using     bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only     enrolled if they fail first line therapy with metoclopramide.   "
47301|NCT02666482|"     The Institute for International Internet Interventions for Health (i4Health) at Palo Alto     University proposes to develop digital tools specifically designed to help low income     English-speaking and Spanish-speaking smokers to quit. The investigators aim to test whether     a mobile-based digital intervention designed with systematic input from low-income English-     and Spanish-speaking smokers from a public sector health care system can significantly     improve its acceptability, utilization, and effectiveness. Using human-centered development     methods, the project will involve low-income patients of the San Francisco Health Network in     the design of a web app/text messaging tool. The investigators will also use participants     input to improve the recruitment and dissemination strategies. i4Health will join forces with     the Center for Behavioral Intervention Technologies (CBITs) at Northwestern University to     iteratively develop successive versions of the digital interventions informed by our     human-centered approach.      The full study involves 4 successive outcome studies testing the effectiveness of the Stop     Smoking San Francisco web app.      The first three are single-group non-randomized pre-post studies with 1, 2, and 3-month     follow-ups. These will test gradually improved versions of the app.      The fourth study will involve a randomized trial comparing the initial version (the baseline     version) of the web app to the final version of the web app, to determine if the final     version is significantly better than the baseline version in terms of increased utilization     and abstinence rates.      To join this study, go to: https://stopsmokingsf.org   "
47302|NCT02666469|"     Stroke is one of the leading causes of disability and death in North America and Europe. Up     to 30% of stroke survivors never recuperate completely and suffer from loss of function and     poor quality of life. To improve recovery after stroke, innovative interventions should be a     priority.      Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric     chamber at a pressure higher than 1 absolute atmosphere (ATA). There is a growing body of     evidence that HBOT can enhance ability of brain to changes its structure (neuroplasticity) in     order to recover. Exercise program during HBOT can augment the effect. Although, recent     randomized controlled trials in patients with chronic brain injury showed promising results,     there are no studies demonstrating combine effect HBOT and exercise rehabilitation program on     stroke recovery.      The proposed study investigates feasibility, safety and efficacy of using a combination of     HBOT and exercise program to improve arm function recovery in chronic stroke patients. In     this pilot randomized control trial, investigators will compare the combination of HBOT and     the focused rehabilitation exercise program versus exercise program alone on recovery of arm     function in patients with chronic stroke.   "
47303|NCT02666456|"     Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by     quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk     factors for neuropathic pain development and chronification in painless and chronic pain     patients.   "
47312|NCT02666339|"     Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry,     because of decompensation. That is why therapeutic treatments are delivered quickly to     treat these symptoms and to allow a better relationship with patients. This relationship     patients-nursing staff called therapeutic alliance is needed in psychiatry. Moreover, other     treatments added to the therapeutic ones are used, like mediation, to increase the patients'     state of health.      These last years, numerous studies were based on hortitherapy or care-gardens. It consists in     the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy     of the care-gardens, but most of them showed methodological weaknesses.      That is why the investigators would like to perform a randomized study, controlled, and they     aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult     psychiatry for at least 4 weeks.   "
47304|NCT02666443|"     Brachial plexus nerve blocks provide superior analgesia over opioids while avoiding unwanted     side effects. Single shot blocks with local anesthetic alone usually do not last the duration     of the acute post-surgical pain period. This has led to the exploration of multiple adjuvants     to increase the duration of single shot blocks, the most promising adjuvant being     dexamethasone.      Peri-neural administration is an off-label use of dexamethasone. While no adverse events have     been reported in human clinical studies, logic would dictate that we minimize the dose needed     to produce the desired effect. Most studies thus far have used peri-neural dexamethasone     doses ranging from 4-10 mg. However, Albrecht et al. found no difference in block duration     comparing 4 mg and 8 mg doses while Liu et al. reported equivalent block duration using doses     of 1, 2 and 4 mg.      Recent studies have evaluated whether systemic and peri-neural administrations of     dexamethasone are equivalent, which would in turn imply a site of action. Results have been     mixed. Four studies concluded peri-neural and intravenous administration are equivalent at     prolonging analgesia, though one study had methodological errors, including the     administration of intravenous dexamethasone to all patients. All of these studies used     dexamethasone doses of 8 to 10 mg. One study where a lower dose (4 mg) was used found that     peri-neural administration prolonged block duration whereas intravenous did not.      With that, the rationale of our study is to determine if equivalent block-prolonging     analgesia can be achieved using low dose (1 mg) dexamethasone given peri-neural or     intravenous. Clinical experience at our centre has been that 1 mg dexamethasone added to 20     mL produces similar block duration to that reported in published studies using higher doses.   "
47305|NCT02666430|"     The aim of this extension study is to assess the safety and efficacy of Mylan's insulin     glargine and Lantus® in T1DM patients.   "
47306|NCT02666417|"     Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia     (IDA), which adversely affects their growth and cognitive development. In-home iron     fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA.     However, in areas with a high burden of infectious diseases iron may increase the risk of     unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there     is an urgent need to find safer formulations of iron fortification for African infants. The     investigators recently finished a randomized, double blind controlled intervention trial in     Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS)     in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the     infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402).     Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement     the intervention study, the present study will compare iron absorption from the combination     of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior     consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale     County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP     containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS.     After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and     will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or     isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second     test meal administration, a whole blood sample will be collected by venipuncture for iron     isotopic analysis. Iron and inflammation status parameter will be determined at baseline and     endpoint. A stool sample will be collected at baseline and on the first test meal day. The     gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron     absorption from the iron and GOS containing MNP will inform decisions on type of iron     compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still     cover the infant requirement for absorbed iron.   "
47394|NCT02665260|"     The purpose of this study is to determine if cantharidin is a safe and effective treatment     for molluscum contagiosum in kids   "
47817|NCT02659722|"     The primary objective of this prospective, post-market study is to collect data to assess the     long term outcome of a broad contact modular interbody device in the form of the InterFuse S™     or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc     disease and/or scoliosis. Comparisons will be made with published historical data..   "
47307|NCT02666404|"     Volume resuscitation is the mainstay of treatment in most types of shock, especially in     hemorrhagic and septic shock. Septic shock is a main cause of morbidity and mortality     worldwide. Although there has been a lot of research to evaluate optimal amount and     composition of fluids for volume resuscitation (e.g. colloids, crystalloids, red blood cell     transfusion, albumin, fresh frozen plasma) particularly in the past decade, results remain     inconclusive and to some extent contradictive. The investigators would like to contribute to     the establishment of new endpoints for the guidance of shock therapy focusing on the first 24     and 48 hours, amending the currently used parameters (i.e. cardiac output, heart rate, blood     pressure, central venous pressure) with new measurements (see study specific measurements).     The goal is to decrease the need for renal replacement therapy, thereby eventually reducing     patient morbidity and mortality.   "
47308|NCT02666391|"     The purpose of the present study is to evaluate the safety and exploratory efficacy of the     umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.   "
47309|NCT02666378|"     This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a     method of detecting early signs of damage to the heart that can be associated with adjuvant     therapy of anthracycline (doxorubicin)-based combination chemotherapy followed by treatment     with herceptin (trastuzumab for the treatment of (HER+) breast cancer.   "
47310|NCT02666365|"     Patients undergoing an elective ventral hernia repair will be randomly assigned to receive     either bolus infusion or continuous infusion of the cefazolin as the prophylactic antibiotic.     The blood concentrations of unbound cefazolin would be measured in their blood samples and     the levels compared within the two groups with respect to their minimal inhibitory     concentration (MIC) value.   "
47311|NCT02666352|"     This is a 2-part, non-randomized, open-label, single-dose study to evaluate the     pharmacokinetics (PK) of uprifosbuvir (MK-3682), its metabolites M5 and M6, and ruzasvir     (MK-8408) in participants with moderate hepatic insufficiency (HI) (Part 1) and in     participants with severe HI (Part 2) compared to those in matched healthy particpants.   "
47330|NCT02666105|"     This is a phase II single institutional therapeutic study of exemestane in post-menopausal     women with advanced non-small cell lung cancer (NSCLC) who have failed at least 1, but not     more than 3 previous treatment regimens.   "
47401|NCT02665169|"     This study evaluates the 6 month exercise intervention (Taiji and gym course) combined with     free use of communal recreation facilities in fall prevention.      Morbidity, use of social services and health outcomes of aging women in province of Kuopio,     Finland are also monitored. The study combines a six months supervised exercise, followed by     six months free, but unsupervised, use of recreational facilities and observational period of     second year into total of 2 year follow up duration.   "
47313|NCT02666326|"     Every year > 50.000 people in Denmark are hospitalized with a suspected acute myocardial     infarction (AMI). The majority has other explanations of their chest discomfort and most are     discharged again without any initiation of treatment. Still, the suspicion dictates acute     ambulance deployment, hospital admission to a highly specialized cardiac unit, cardiac     surveillance and cardiac troponin blood sampling. The novel biomarker copeptin, a byproduct     of vasopressin production, is released immediately from the pituitary gland as part of the     hormonal response to AMI. Peak concentrations are reached within the first hour. Previous     studies have suggested the combination of copeptin and cardiac troponin for fast and reliable     rule out of AMI. However, the blood sampling should be performed as soon as possible after     symptom onset, preferably already during the prehospital phase.      We aim, in an open randomized setting, to investigate the combined measurement of prehospital     copeptin and in-hospital high sensitive cardiac Troponin T compared to the standard rule-out     procedure of suspected myocardial infarction. We hypothesize that the combined measurement of     prehospital copeptin and in-hospital high sensitive troponin T:        1. Reduces admission time by 1.5 hours in patients where AMI is ruled out        2. Reduces the time to disposition        3. Is non-inferior compared to the standard rule-out procedure in relation to major adverse          cardiovascular events.        4. Is more cost efficient compared to standard diagnostic strategy   "
47314|NCT02666313|"     Regular exercise is a core component of the long-term management of people with axial     spondyloarthritis (axial SpA). However, delivering long-term exercise programmes is     unrealistic and unsustainable using traditional NHS services. Web-based physiotherapy, has     been developed, a possible alternative service model to support people with axial SpA to     exercise regularly however long-term compliance to the programme (12 months) needs to be     established. The aim of this prospective cohort study is to assess the feasibility,     sustainability and acceptability of a 12 month individualised web-based physiotherapy     programme in people with axial SpA. Fifty people with established axial SpA, will receive 12     months of individualised, remotely monitored, web-based physiotherapy. The primary outcome     will be four weekly compliance rates with the programme over the 12 month period. Secondary     outcomes (baseline, 6 and 12 months) will include function, disease activity, spinal     mobility, quality of life, attitudes and motivations towards exercise, fitness, health     status, employment, physical activity. The number of interactions with health care     professionals and changes in medication will be documented. A subsample of the cohort will be     interviewed at 6 and 12 months to gather participants' views of the web-based physiotherapy     programme and factors influencing compliance with the programme.   "
47315|NCT02666300|"     Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory     complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT)     to decrease or to increase the complications of general anesthesia compared with     Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different     incidence of complications following general anesthesia between TaperGuard ETT and     Cylindrical-shaped ETT under high endotracheal tube cuff pressure.   "
47406|NCT02665104|"     The primary endpoint of our study is to determine whether neurological symptoms (aphasia,     paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery,     and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive     regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters     after the internal carotid artery is clamped, and if there is any difference between the     operated and non-operated sides?   "
47316|NCT02666287|"     Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and     beta2-agonism in a single molecule and is in development for the treatment of chronic     obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled     corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting     beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product in     combination with BAT, for treatment of COPD.      This study is an open-label, six-way crossover, single and repeat dose study to evaluate the     systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the     ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a     single dose, and at the proposed clinical dose, following repeat doses.      This study will consist of screening period, 6 treatment periods, and a follow-up visit. Each     subject will have 3 periods in which they receive a single dose treatment regimen (3     inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a     single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of     those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8,     subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a     minimum of 7-day washout between each treatment periods. All subjects will receive 9     treatments and follow-up procedures will be done 7 14 days after the last dose.      Forty eight healthy subjects will be enrolled into the study, such that approximately 40     subjects complete dosing and PK assessments. The total duration of participation for each     subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the     GlaxoSmithKline [GSK] group of companies.   "
47317|NCT02666274|"     There are many bacteria that naturally live in our gut and are essential for good health.     These bacteria have a variety of helpful functions, such as aiding digestion, synthesizing     vitamins, repressing the growth of harmful bacteria and defending against some diseases. The     desirable bacteria that live in the gut are collectively known as 'gut flora', or more     appropriately, as 'gut microbiota'.      The less desirable resistant bacteria, however, can also be carried in a person's gut for     prolonged periods of time and be found in the stools without causing illness. Persons that     carry the resistant bacteria in the gut are known as carriers and they require no     treatment. Knowing that a person carries resistant bacteria is helpful, because it will     inform the choice of antibiotic if the person were to become unwell or had an intervention     such as surgery in the future.      There is some evidence that resistant bacteria found in the stools can sometimes be passed     from one person to another and eventually make someone ill if they infect (invade) their     body. The investigators do not know how often this may happen, or how much carrying resistant     bacteria in the stools may facilitate the spread of resistant bacteria in the population. It     is important to address these questions and study ways to stop the resistant bacteria from     spreading to safeguard the efficacy of antibiotics.   "
47318|NCT02666261|"     This non-interventional study will collect data from routine diagnostics on HER2 testing of     breast cancer in Germany.   "
47319|NCT02666248|"     This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received     retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol     have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv     Chimeric Antigen Receptor (CAR).   "
47358|NCT02665728|"     The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in     constipated adolescent subjects.   "
47320|NCT02666235|"     Intermittent arm cuff inflation reduces the extent of heart muscle injury at the time of     cardiovascular injury. The intervention is known as remote ischaemic conditioning (RIC)     however the mechanisms by which RIC acts are incompletely understood.      One mechanism that might explain the benefits of RIC is an improvement in coronary artery     function which in turn might help improve blood flow to heart muscle.      The investigators will perform a randomised controlled study of RIC in a minimum of 60     patients with known or suspected angina and in whom coronary angiography with angioplasty     would be considered.      Following informed consent before the invasive procedure, the patient will be randomly     assigned to the intervention group (cuff inflation protocol) or the control group (cuff     placement, no inflation; sham protocol). Following initial coronary angiography, endothelial     function will be assessed by intra-coronary infusion of acetylcholine in incremental doses.     Coronary diameter will be measured after the procedure using quantitative coronary     angiography, by a trained observer blinded to the allocated group. Since a neuro-hormonal     response may potentially mediate RIC, a blood test will be performed before and after cuff     placement in all patients (active and control groups) to measure circulating molecules known     to regulate blood vessel function which may be implicated in a RIC-mediated effect on     coronary artery tone.      This study may provide clinically relevant insights into the mechanisms of action of RIC in     patients with coronary heart disease.   "
47321|NCT02666222|"     The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem®     Hearing Implant in subjects suffering from moderate to severe hearing loss.   "
47322|NCT02666209|"     Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are     currently participating in a clinical trial which is closing. This research study is studying     Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657   "
47323|NCT02666196|"     This is a placebo-controlled randomized phase 1 study to investigate the safety and     pharmacokinetics of DAA-I in a cohort of healthy subjects.   "
47324|NCT02666183|"     This study seeks to test the effectiveness of two arms of an intervention that use     videoconference technology for distance caregivers of patients with advanced cancer. The     study is significant because the intervention will promote involvement of caregivers of     patients with cancer and makes a compelling case for significance based on changing     demographics and lifestyles.   "
47325|NCT02666170|"     The aim of our study is to investigate the effects of six months treatment with alpha-lipoic     acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual     pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral     glucose tolerance test and hormonal assays are evaluated before and after therapy.   "
47337|NCT02666014|"     The laparoscopic technique is commonly employed for abdominal gynaecological surgery in     women. Postoperative nausea and vomiting (PONV) may occur in 30% of women undergoing     gynaecological surgery. In patients with multiple risk factors for nausea and vomiting, the     incidence is up to 80%. PONV has a significant negative effect on patient satisfaction after     anesthesia and is one of the most common causes for unexpected hospital admissions in     day-surgery.      Sugammadex and Neostigmine are both drugs that are used to reverse the effect of muscle     relaxation producing drugs that are commonly used during surgery. Neostigmine has been the     drug of common use for this purpose, but PONV is reported with its usage.      With this research we intend to determine whether the trial drug Sugammadex would reduce the     incidence of PONV in high-risk women after undergoing laparoscopic gynaecological surgery     when compared to Neostigmine.   "
47818|NCT02659709|"     Develop smartphone- and tablet-based application (app) for participants with glaucoma, ocular     hypertension and those at risk.   "
47326|NCT02666157|"     1. The recent development of novel oral anticoagulants (NOACs), including direct thrombin          inhibitor (dabigatran) and factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban),          could potentially overcome many drawbacks of warfarin, and might provide a safer, and          even more effective and convenient alternative approach to warfarin in non-valvular          atrial fibrillation (NVAF), especially in Asians.        2. According to the results of a meta-analysis comparing Asians and non-Asians, NOACs are          preferentially indicated in Asians in terms of both efficacy and safety.        3. There is no randomized controlled trial with sufficient power to directly compare the          efficacy and safety among NOACs in NVAF, not to speak of Asians and Chinese.        4. Indirect comparisons are only based on observation with a lot of limitations such as          heterogeneous background characteristics, difference in study design, and diversity in          time within therapeutic range in control group. The findings from indirect comparisons          are not conclusive but only hypothesis-generating.        5. This investigator-initiated prospective randomized open blinded end-point clinical trial          will directly compare the efficacy and safety among 3 NOACs in patients with NVAF in          Taiwan. We hypothesize that rivaroxaban or apixaban is non-inferior to dabigatran in          terms of the efficacy.   "
47327|NCT02666144|"     This prospective, monocentric, non-invasive clinical study is designed to measure normal     structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer,     and the macula using the Heidelberg Spectralis OCT device. This study is conducted in normal,     healthy volunteers and glaucoma patients. The main goal of the study is to provide an     analysis of the comparability of these parameters between two different software versions and     their respective method of scan centration on the optic disc center. The study will include     at least 40 eyes of 40 subjects; 20 normal, healthy subjects and 20 glaucoma patients. All     subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, and     visual field testing in one single visit. Total study duration (first patient first visit to     last patient last visit) is anticipated to be approximately 4 weeks.   "
47328|NCT02666131|"     The purpose of this study is to determine whether Granexin gel is safe and effective in the     treatment of diabetic foot ulcers.   "
47329|NCT02666118|"     Nerve blocks, or pain medication injected next to the nerve while patients are asleep, are     commonly used for pain management after shoulder surgery and are considered highly effective     in decreasing post-operative pain. There are several different ways to give a nerve block.     All are effective and safe. The purpose of this research is to determine if one of the     available ways to give a nerve block is more effective than the others.   "
47331|NCT02666092|"     Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are     recognized as zoonotic diseases agents, and have a high impact on human health.      Infestation results from the ingestion of living larvae from contaminated fishes. It can be     asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms.     Allergic manifestations are frequently encountered in gastric forms, but allergic symptoms     can also occur in isolation, after ingestion of Anisakidae antigens contained in raw or     cooked fish, and may masquerade as fish allergy.      In this study, we aim to characterize the relationship between Anisakidae and/or fish     sensitization and the presence of allergic manifestations in patients recruited in the     general population and presenting fish allergy resulting from ingestion, cutaneous or     respiratory contact. We will also determine the respective role of Anisakidae or fish     sensitization in patients with fish allergy. Then, we will determine the prevalence of     previous Anisakidae infections among these patients and a matched control population. We will     also compare the performances of serological tests (ImmunoCAP, immunoelectrophoresis and     Western Blot) for the diagnosis of Anisakidae allergy or infection. Lastly, we will explore     the relationship between domestic exposure to Anisakidae or fish antigens and the occurrence     of associated pathologies (Anisakidae or fish allergy/sensitization; Anisakidae infection).   "
47332|NCT02666079|"     This study is a prospective, randomised, controlled multi-centre study to examine outcomes     following wide local excision (WLE) for breast cancer with (treatment arm) or without     (control arm) intra-operative use of the LightPath™ Imaging System.      The intraoperative 18F-fluorodeoxyglucose (18F-FDG) LightPath™ Images will be used to inform     the surgeons about detectable residual cancer, in an attempt to achieve better guided cancer     surgery and complete tumour excision with clear WLE resection margins.      Study sites will use the local criteria considered standard of care to guide decisions to act     on positive margins.      In the LightPathTM arm the resection margin status of the WLE specimen, cavity shavings (if     any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the     LightPath™ Imaging System will be compared with histopathology results.   "
47333|NCT02666066|"     Radiomics, the extraction of large amounts of quantitative image features to convert medical     images into minable data, is an in-development field that intends to provide accurate risk     stratification of oncologic patients. Published prognostic scores only take clinical     variables into account. The investigators hypothesize that a combination of CT/MRI features,     molecular biology and clinical data can provide an accurate prediction of medical outcome.     The long term objective is to build a Decision Support System based on the predictive models     established in this study.   "
47334|NCT02666053|"     The purpose of this study is to estimate the effect of high fat meal and increased gastric pH     on BMS-663068 bioavailability   "
47335|NCT02666040|"     With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to     investigate the benefits in terms of incidence of pain and discomfort, improvement in the     quality of life for the patient after the use of the newly introduced semi-absorbable     prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material     (conventional meshes in polypropylene Prolene®), and in terms of the costs for the     hospital, the National Health System (NHS), and the society of associates for the use of the     ULTRAPRO® in inguinal hernia surgeries.   "
47336|NCT02666027|"     This study is being performed to determine the effectiveness of Fluid Intravenous Alert     (FIVA) in monitoring intravenous fluid delivered to patients under anesthesia in a dimmed     ambient light in the operating room.   "
47339|NCT02665988|"     Transcranial direct current stimulation (tDCS) is an investigational device that has not been     approved for the treatment of any medical condition by the FDA but is allowed to be used for     research purposes. In clinical trials tDCS has been associated with pain relief by decreasing     the intensity and duration of chronic pain. tDCS potentially works by stimulating the brain     by delivering an extremely low-level electrical current to areas below the forehead - areas     associated with chronic pain. It is anticipated that this current will increase brain     activity or the likelihood of brain activity in these areas, affecting individual's ability     to regulate pain.      The purpose of this study is to compare eligible participants in the Pain Management Program     at The Menninger Clinic receiving adjunctive real transcranial Direct Current Stimulation     (tDCS) versus those receiving sham tDCS in the resolution of chronic pain. The primary     objectives are: (1) improving pain tolerance and (2) improving subjective pain experience.     Secondary objectives are: (1) improving subjective experience of sleep quality and (2)     increasing physical activity.   "
47340|NCT02665975|"     The purpose of this study is to compare the effectiveness of a CBT-based internet     intervention with face to face standard clinical care for adults with tinnitus in the United     Kingdom.   "
47341|NCT02665962|"     80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data     have shown that caloric restriction (CR) protects against organ injury and decreases     perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week     perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed     endometrial cancer patients. The intervention will provide individualized CR program, meal     replacement products and nutritional counselling sessions.   "
47342|NCT02665936|"     The purpose of this study is to detect whether the addition of epidural dexamethasone will     prolong labor analgesia.   "
47343|NCT02665923|"     Ultrasound imaging will be used to (1) evaluate gastric antral volumes in children presenting     for anesthesia who have been fasted, and (2) to evaluate time for gastric emptying in     healthy, fasting newborns, and infants following feeding of clear liquids and/or milk     (including breast or formula).   "
47344|NCT02665910|"     Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator     Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment,     Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized   "
47386|NCT02665364|"     The safety and immunogenicity of the IFN-Kinoid (IFN-K) have been evaluated in a phase I     clinical study conducted in subjects with SLE. Preliminary results were promising.      The principal aim of the present study is to confirm the neutralization of the interferon     gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the     immune responses and the safety elicited by IFN-K will also be evaluated.   "
47345|NCT02665897|"     In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney     impairment characteristics, a recent study demonstrated that the serum levels of NGAL     increased at the end of the second trimester in women who subsequently developed     pre-eclampsia compared to the control group.      This correlates well with the endothelial damage that occurs during pre-eclampsia and thus     NGAL can be considered as a promising marker in predicting both early and late onset     pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the     precision, and sensitivity for detection of risk and reliability of using biomarkers for     pre-eclampsia.   "
47346|NCT02665884|"     Diurnal fluctuations of intraocular pressure in EX-Press Valve Blebs in Glaucoma Patients      Intraocular pressure (IOP) reduction is the mainstay of glaucoma management. (1) Open-angle     glaucoma (OAG) is generally managed by decreasing the intraocular pressure (IOP) to a level     that the physician believes will prevent further glaucomatous damage. However, in a     significant proportion of patients, the visual fields continue to deteriorate in spite of     office pressures within the range of normal values (8). It has been suggested that the     progressive damage in some cases could be caused by peaks of IOP or diurnal IOP variability     not detected by tonometry during office hours. It is possible that certain drugs or surgical     interventions are more effective than others in dampening these fluctuations. The purpose of     our study is to compare the diurnal IOP fluctuations in glaucoma patients treated with     medications or Ex-press filtration surgery.   "
47347|NCT02665871|"     This study evaluates the safety of freeze-dried live attenuated influenza vaccine for     intranasal administration in chinese adults aged 3 years and older.80 subjects will be     divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each     groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.   "
47348|NCT02665858|"     Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides     therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains     a limited method of producing quantitative data in evaluating in patients with IIH.      In this study we intend to compare, by using spectral domain optical coherence tomography     (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT)     of the optic nerve of newly diagnosed IIH children to a control group. This will provide a     quantitative measure for follow-up and treatment of this patient group.   "
47349|NCT02665845|"     The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well     established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA)     agents in the form of mesalamine/mesalzine are well established proven therapy in     mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was     shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most     cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is     usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the     flare is controlled. If this is unhelpful, or if the flare is severe to begin with,     corticosteroids are usually prescribed. However, there are very scarce data comparing     steroids versus 5-ASA in the treatment of severe UC exacerbation.      The aim of this study is to compare the efficacy of steroids alone vs. combination of     steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.   "
47350|NCT02665832|"     The purpose of this study is to compare the safety and pharmacokinetic characteristics of     combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers   "
47351|NCT02665819|"     PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and     biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia     Children's Hospital in Holland.      Ensure optimal patient quality of life throughout his life is a priority for the research     teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired     quality of life. It is in this light that will be offered to patients a quality of life     questionnaires during the period of treatment and then periodically during long-term     follow-up.   "
47353|NCT02665793|"     Food allergy affects up to 10% of the population. The mainstay of management involves dietary     avoidance and provision of rescue medication in the event of an accidental reaction. The     Integrated approaches to food allergen and allergy management (iFAAM) collaboration is an     EU-funded academic/clinical/industry consortium with the aim to improve allergen risk     management including food labelling. Much of this work requires the validation of the minimum     'eliciting dose' for the food-allergic population and how this can be translated into risk     management.      A number of studies (including iFAAM and the TRACE study - NCT01429896) have assessed the     eliciting dose for peanut allergic patients, using food challenges where peanut-allergic     individuals are eat incremental doses of peanut under strict medical supervision.      In this extension study, peanut-allergic subjects will have undergone (in a cross-over     manner) three double-blind, placebo-controlled food challenges to peanut:        1. incremental doses of peanut in a water-continuous matrix;        2. incremental doses of peanut baked into a cookie biscuit;        3. a single dose of peanut in a water-continuous matrix.      The differences in eliciting dose, symptom pattern and underlying physiological mechanisms     will provide essential data on how the presentation and consumption of peanut affects the     amount needed to trigger an allergic reaction, to inform industry and food regulators as to     how to best protect the food-allergic population.   "
47354|NCT02665780|"     This study evaluates the short and long term effect of dental cleaning and mouthrinsing for     the treatment of bad breath   "
47355|NCT02665767|"     The investigators investigated the feasibility of the clinical application of     novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the     appendix.   "
47356|NCT02665754|"     The investigators will perform double-blinded placebo-controlled randomized clinical trial     which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy     (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus     (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with     allergic rhinitis (AR), using allergen extracts for allergen-specific immunotherapy (Tyrosine     S, Allergy Therapeutic, West Sussex, UK).   "
47357|NCT02665741|"     The goal of this study is to compare two FDA approved distal colonoscope attachment devices,     in order to identify which device can increase adenoma detection rate the most without     increasing procedure time or risk.   "
47359|NCT02665715|"     Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing     higher peak blood glucose concentration early after meal intake. In the late postprandial     period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some     patients, overt postprandial hypoglycaemia develops, and is typically reported as a     complication 1-5 years postoperatively, when maximal weight loss has been obtained. The     pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of     insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1     (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole     body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces     postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive     hypoglycemia prevented.   "
47360|NCT02665702|"     The aim of this study is to explore whether endostar combined with NVB and DDP as treatment     could improve progression-free surial time (PFS) and to evaluate the safety of the     chemotherapy regimens   "
47361|NCT02665689|"     The aim of the prospective randomized study is to investigate whether a intensified diabetic     control program leads to better final visual acuity and less frequent diabetic ocular     complications in patients with diabetic retinopathy when compared with a normal diabetic     treatment.   "
47362|NCT02665676|"     The aim of this study is to investigate demographic & disease characteristics of pediatric     cancer patients diagnosed with one of embryonal tumors to identify the prevalence, the     spectrum of these disease entities & treatment outcomes in these patients.   "
47363|NCT02665663|"     Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis that     occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants.      Swallowing disorders occur during evolution and involve the prognosis of patients in the     short term by the association of dysphagia with severe malnutrition, and aspiration. The     issue of phoniatric monitoring is to detect early onset of the swallowing disorders to     develop strategies for respiratory protection, food adapted to disturbances, and speech     therapy.      The objective of this study is to compare the tongue force in patients with amyotrophic     lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared     to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole     et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the     measurement of the strength and duration of the pression of the tongue on the palate.   "
47364|NCT02665650|"     The purpose of this study is to establish a dosing regimen for the combination therapy of     AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin     Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.   "
47365|NCT02665637|"     This is a double-blind, two-arm, parallel-group, single-dose study.   "
47366|NCT02665624|"     Adequate bowel cleansing is essential for optimal colonoscopic examination. However, none of     the colonoscopy preparation regimens is safe, efficient and also comfortable. The     investigators' aim was to determine whether adding stewed apricot juice to senna increases     patient comfort and improves bowel cleansing during colonoscopy preparation.   "
47367|NCT02665611|"     Moma call center will provide unique service -Remote monitoring and support for mental health     patients .The aim of this reserch is reducing hospitalization and improve adherence, by     reaching out and there for monitoring very closely .   "
47407|NCT02665091|"     Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years.     Studies in various countries show that both out of school and in school adolescents and youth     are engaged in risky sexual behaviors. Peer-based interventions have become a common method     to effect important health-related behavior changes and address the HIV/AIDS pandemic. This     study therefore aimed to evaluate the effectiveness of peer education in improving HIV     knowledge, attitude, and preventive practices among in-school adolescents   "
47368|NCT02665598|"     Posterior Reversible Encephalopathy Syndrome (PRES) is a clinical-radiological entity, which     is associated with a variety of clinical conditions. The imaging and clinical findings are     typically reversible, but many patients still have permanent neurological sequelae with a     fatal outcome. Up to now there are no consistent conclusions about the factors that affecting     its prognosis. The objective of our study is to discuss the effects of different causes,     different imaging findings and laboratory parameters on the prognosis of PRES and deepen the     understanding of the nature of PRES. This will contribute to predict the prognosis of     patients with PRES and to further investigate the pathogenesis of PRES so as to guide the     clinical treatment and follow-up evaluation. A multi-center retrospective case study will be     performed from January 2016 to July 2017 and a total of 400 patients who meet the criteria     for PRES diagnosis from 10 sub-centers are anticipated included in this research. Patients     will be divided into several subgroups according to the etiology. Date will be collected from     the clinical records，imaging and laboratory data of the patients, including demographic data,     clinical data, imaging findings, laboratory parameters and follow-up data. During the     follow-up, MRI and blood biochemical examination will be performed once more. The imaging     findings of the patients will be assessed by two neuroimaging physicians, any difference     between them will be agreed upon by consensus. Prognosis of the patients will be assessed by     using the modified Rankin scale (mRS) scores. All of the above data is saved into the     database. In this study we will review etiologies and imaging findings, laboratory and     follow-up data of the patients we selected. Univariate and multivariate analysis will be     performed within the group and between groups according to the subgroups. Then we will     discuss the connection between different causes, different imaging findings and laboratory     parameters and the prognosis of posterior reversible encephalopathy syndrome.   "
47369|NCT02665585|"     The aim of the present positive-control study is to analyze and compare the rate of off-table     subclinical neurological events in two groups of patients submitted to carotid artery     stenting (CAS) with two different kind of stents, a close-cell stent, and the new     mesh-covered stent, so to verify if the new model of stent is effective in preventing     postprocedural carotid plaque embolism.   "
47370|NCT02665572|"     In this study, investigators will prospectively evaluate the outcome of renal transplantation     into a defunctionalized bladder by comparing direct transplantation into this     defunctionalized bladder and pre-transplant programmed bladder cycling.   "
47387|NCT02665351|"     Peramivir is the first intravenous neuraminidase inhibitor (NAI) available for treatment of     uncomplicated influenza in adults. Data from placebo-controlled trials in outpatients have     shown antiviral efficacy, safety, and tolerability. Although the unmet need for intravenous     therapy lies mainly with patients hospitalized with complicated diseases, such data are     limited because of feasibility and ethical considerations for placebo-controlled studies.      In this study, the investigators aimed to examine more specifically treatment effects of     peramivir in adults hospitalized with influenza-associated lower respiratory tract     complications (LRTC). Such findings may have important implications on clinical management.   "
47371|NCT02665559|"     Testosterone deficiency is classically associated with the development of metabolic syndrome,     osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and     alteration of the quality of patients life.      Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss     and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand,     abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells     causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular     invasion by lymphoma or Kaposi's syndromes have also been described.      The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients     infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless     of the antiretroviral therapy and CD4-T cell count.      No study to our knowledge has so far assessed exhaustively the clinical features, biological,     therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum     testosterone, SHBG and serum free testosterone, among HIV infected patients in the European     population.   "
47372|NCT02665546|"     Pulmonary Langerhans Histiocytosis Cells (PLCH) is characterized by infiltration of     Langerhans cells and formation of loose granulomas with lymphocytic infiltrate and formation     of nodular and cystic lesions on chest CT, and is often associated with smoking.     Functionally, there may be obstructive and / or restrictive defect, with reduced carbon     monoxide diffusing capacity. Dyspnea and lower exercise tolerance are common in PLCH, but     exercise capacity in this disease is poorly understood and has not been compared to controls.     Besides, the mechanisms involved in limiting exercise are poorly understood and cover     multiple factors such as change in gas exchange, pulmonary hypertension (PH), dynamic     hyperinflation, physical deconditioning and left heart failure. The involvement of pulmonary     circulation in PLCH has unknown prevalence, but contributes to the symptoms. In the PH     classification, PLCH belongs to the group 5, of multifactorial etiology. The definition of     the presence and contribution of dyspnea mechanisms in different severities of PLCH is     important to understanding the disease and individualization of treatment. The objective of     the study is to evaluate the exercise capacity of patients with HCLP, and determinate     mechanisms of dyspnea and lower exercise tolerance beyond its impact on quality of life.   "
47373|NCT02665533|"     The main aim of the study is to investigate the pre-emptive effect of dexamethasone and     diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the     extraction of third molar.   "
47374|NCT02665520|"     Autologous Fat Derived Stem Cell treatment of ED.      To assess safety and primary efficacy of stem cell infusion in refractory ED.      To investigate the success rate and durability of success of using this new therapy in     management of moderate and sever cases of erectile dysfunction.   "
47375|NCT02665507|"     Back pain is a common complaint among pilots. Current treatments include physiotherapy and     chiropractic manipulations. Low-level laser irradiation (LLLI) in the visible to     near-infrared range was shown to reduce neck and low back pain.      The purpose of the study is to evaluate the efficacy of Light Therapy for treatment of back     pain in pilots.   "
47376|NCT02665494|"     Multi-centric, observational, prospective study, designed for pts with diagnosis of     all-stages cholangiocarcinoma, including rare and crossing-over histological types, and     excluding gallbladder cancer and ampullary carcinoma.   "
47377|NCT02665481|"     The purpose of this research is to examine the effects of four interventions on age-related     cognitive decline in healthy older adults. The investigators will examine the effects of     Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based     aerobic exercise, and their combination, compared to a discussion group.   "
47378|NCT02665468|"     On October 1, 2016, the VHA Office of Telehealth and the Connected Health Office will merge     to create a single entity that will be responsible for the implementation and evaluation of     eHealth technologies across the healthcare system. In an effort to successfully fulfill its     mission, the new combined Connected Health/Telehealth Office is pledging $1,100,000 for an     eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of     eHealth technologies across VHA, and to measure their impacts on dimensions of access and     other outcomes. Developed in close consultation with leadership of the new office, the     proposed objectives of the eHealth PEI are to (1) implement a patient-level supported     adoption intervention for secure messaging and evaluate the impact of secure messaging use     through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA's     automated telehealth text messaging system to Veterans and clinical team members.   "
47379|NCT02665455|"     To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when     used at home by pregnant women with diabetes.   "
47383|NCT02665403|"     Hospitalization is a stressful and threatening experience, which can be emotionally     devastating to children. Hospital play interventions have been widely used to prepare     children for invasive medical procedures and hospitalization. Nevertheless, there is an     imperative need for rigorous empirical scrutiny of the effectiveness of hospital play     interventions, in particular, using play activities to ease the psychological burden of     hospitalized children. This study tested the effectiveness of play interventions to reduce     anxiety and negative emotions in hospitalized children. A non-equivalent control group     pre-test and post-test, between subjects design was conducted in the two largest acute-care     public hospitals in Hong Kong. A total of 304 Chinese children (ages 3-12) admitted for     treatments in these two hospitals were invited to participate in the study. Of the 304     paediatric patients, 154 received hospital play interventions and 150 received usual care.   "
47384|NCT02665390|"     This study is focus on percutaneous cryoablation,which was for the treatment of medically     inoperable Peripheral lung cancer.The patients who were agreed to attend the study will     accept the operation. After the operations,they will follow up according to the plan.   "
47385|NCT02665377|"     Prospective, blinded, placebo-controlled trial. Patients: Adult patients (>18 years of age)     undergoing de novo Htx, with a preoperative GFR > 30ml/min, not receiving an ABO-incompatible     organ with an ischemia time of > 6 hours. A donor age > 70 years is an exclusion criteria.      Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia.      Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5     Days after Htx plus after 3 and 12 months.   "
47388|NCT02665338|"     Cigarette smoking causes significant morbidity and mortality in the United States. Smoking     cessation is difficult, with the average smoker attempting to quit five times before     permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain     stimulation for smoke cessation is an exciting new area that builds on advancing neuroscience     knowledge concerning the functional neurocircuitry of addiction. Cortical stimulation can now     be performed non-invasively by transcranial magnetic stimulation (TMS). Several studies have     shown that TMS can reduce cue-elicited craving in smokers. Previous research by group has     shown that a single session of 15 minutes high frequency (10 Hz) repetitive TMS (rTMS) at     100% motor threshold over the left dorsal lateral prefrontal cortex (DLPFC) can reduce     cue-induced craving compared to sham TMS. However, the mechanism by which craving is reduced     by rTMS is poorly understood both at behavioral and neural levels. Neuroimaging studies in     nicotine dependence have revealed cue-related responses in numerous brain areas, including     frontal, parietal cortices and subcortical areas. Recently functional magnetic resonance     imaging (fMRI) studies by the group have shown that cue-induced craving induced brain     activation in ventral medial prefrontal cortex (VMPFC), including medial frontal, orbital     frontal and anterior cingulate. This Chair Research Development Fund (CRDF) pilot proposal     will integrate two new techniques- TMS and fMRI to investigate DLPFC-VMPFC pathway in     smokers. Using double-masked methods investigators hypothesize that cue-induced exposure will     induce brain activity in VMPFC, and 15 minutes rTMS over DLPFC will reduce cue-induced     craving through modulating DLPFC-VMPFC pathway (increased activity DLPFC and decreased     activity VMPFC).   "
47389|NCT02665325|"     Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become     the malignant neoplasm of fastest growing incidence rate. More than 90% thyroid carcinoma is     thyroid differentiated carcinoma（DTC）. Postoperative oral L-thyroxine suppressing thyroid     stimulating hormone (TSH) treatment is the standard therapy in DTC patients. While     TSH-suppressive therapy with L-thyroxine can cause subclinical hyperthyroidism in treatment     of patients with thyroid differentiated carcinoma. The impact of this therapy on cognitive     functions and mood have not been systematically studied. The investigators infer the     subclinical hyperthyroidism caused by TSH-suppressive therapy may impact cognitive function     and mood disorders in DTC patients. The aim of this study is to explore the possible     mechanism of cognitive function impairment in the course of TSH-suppressive therapy by rat     model of total thyroidectomy + TSH-suppressive therapy and clinical trials. The result of     this study may provide clinical and experimental basis for the side effects risk result form     TSH-suppressive therapy in DTC patients.   "
47390|NCT02665312|"     observational prospective study, designed for patients with colorectal cancer receiving for     the first time 5-FU or capecitabine, with or without other chemotherapy combinations.   "
47391|NCT02665299|"     When the DNA inside of human cells undergoes certain alterations (mutations), the cells may     develop into a cancer. The cancer cells may shed this DNA into the blood stream. This     circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory     tests. Measurement of ctDNA has been shown to be useful for following patients with known     cancer. It has also been found in the circulation of some patients with early stage cancer.     The purpose of this study is to examine blood specimens for the presence of ctDNA in     individuals without known cancer who are scheduled to undergo a screening or diagnostic     colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition     at a very early stage before the patient becomes symptomatic. The results of this study     should help define the role of ctDNA in the detection of early stage colon cancer and to     define how sensitive it is (i.e. how well it picks up cancer when it is present) and how     specific it is (i.e. how often is ctDNA found in patients with benign diseases or no     abnormalities).   "
47395|NCT02665247|"     The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood,     anxiety and well-being measures in a sample of college students. College students have a high     prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and     insomnia. Sleep disorders in college students negatively affect mood, social functioning,     physical safety, and academic performance. Rarely recognized by the students themselves,     these conditions are therefore often untreated. Participants in this study will be randomly     assigned to receive the College Sleep Improvement Plan (C-SIP) or a control session.     Participants will be asked to track their sleep as well as complete questionnaires; a subset     of participants will be asked to wear an activity monitor.   "
47396|NCT02665234|"     The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic     Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry     eye disease.   "
47397|NCT02665221|"     The primary purpose of this single center, randomized, open label study in relapsing Multiple     Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect of     Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of     injection site erythema after PLEGRIDY injection.   "
47398|NCT02665208|"     The primary purpose of this study is to understand the feasibility of a text messaging     intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve     smoking cessation among opiate and/or alcohol dependent participants discharged from an     inpatient detoxification unit and enrolled in an office-based buprenorphine program patients     (OBBP). Participants will be randomized to 1) treatment as usual (TAU) comprised of     informational pamphlets and information for a 1800 quit line; and a prescription for a     nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity     of baseline self-reported smoking, or nicotine replacement gum (2mg) #10, for 28 days which     is offered routinely to all inpatients at Bellevue at the time of discharge) versus the     SmokeFreeTXT intervention plus prescriptions for NRT.   "
47399|NCT02665195|"     This study is being done to learn more about how changes in certain genes may be linked to     cancer. Some people with cancer got their disease because they inherited an abnormal     (mutated) gene.      The researchers of this study want to better understand the risks that are linked to genetic     changes in these less well-studied genes. By understanding these risks, we believe that     doctors will be able to give better advice to families with mutations in these genes.   "
47400|NCT02665182|"     This is a single-blinded RCT evaluating the value of up-positioning of the testes as     supportive therapy in patients receiving antimicrobial treatment due to acute bacterial     orchitis.   "
47402|NCT02665156|"     Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with     totally intracorporeal stapled orthotopic neobladder remains a main drawback of this     procedure. According to a recent consensus panel, the benchmark for intracorporeal orthotopic     neobladder should be 5 hours in high volume centers .      This prospective single-stage phase 2 trial is designed to assess the time efficiency of     using robotic stapler versus the conventional motorized staplers (Linear stapler articulated     Endo GIA™, Covidien) in achieving the target outcome (total operative time <5 hr).      Perioperative complications (intraoperative and 30-d postoperative complications according to     the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates,     early functional outcomes (time to recovery of urinary continence), 180-d and 360-d     neobladder stone formation rates will be analyzed to assess the safety and the cost     effectiveness of the procedure.   "
47403|NCT02665143|"     The purpose of this study is to determine if a combination of nintedanib+ induction     chemotherapy can be an effective strategy for patients where outcome of relapse/refractory     acute myeloid leukemia (AML) is poor.   "
47404|NCT02665130|"     Tai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese     population but no data exist concerning metabolic responses to Tai-Chi in COPD patients.     Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a     Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian     population. Classical western style pulmonary rehabilitation will serve as a comparator     Investigators propose a prospective randomized controlled trial in which 120 bronchodilator     naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and <80 %     of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70) are randomized to receive     a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary     Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province,     China) will be recruited.      Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural     location in southern China (Xingning). A qualified UK Physiotherapist will also be involved     in the management of pulmonary rehabilitation program to further make sure the high quality     of pulmonary rehabilitation has been applied. Both arm participants will also receive in an     open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups     (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this     study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol     at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk     distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The     investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.   "
47405|NCT02665117|"     Chlorthalidone (CTD) may produce various metabolic disturbances, including hypokalemia,     activation of Renin-Angiotensin- Aldosterone (RAA) system, oxidative stress, dyslipidemia,     Fibroblast growth factor 23 (FGF23) synthesis, and magnesium depletion. These factors may     interact with each other to contribute to the development of insulin resistances and     metabolic syndrome. Smaller studies have suggested that Potassium magnesium Citrate (KMgCit)     can ameliorate CTD- induced metabolic side effects independent of correction of hypokalemia.     This study will tests if KMgCit ameliorates CTD induced metabolic effects independent of     correction of hypokalemia.   "
47408|NCT02665078|"     The ex-vivo lung will be evaluated by XLTF-UC180 for localization of the tumor. The     ultrasound probe will be put on the lung surface in several different directions to obtain     the cross section with maximum diameter. The ultrasound image with size measurement of the     tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP.,     Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized     endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the     lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images     between deflated and inflated lung. After ultrasound evaluation, the specimen will be     delivered directly to the pathology laboratory and the actual tumor size and histological     diagnosis will be determined. In addition, we will evaluate the differences between US image     and pathological morphology using HE slides of lung tumor. We will work together with the     surgical team to confirm sign off of specimens.   "
47409|NCT02665065|"     The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction     with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic     hematopoietic stem cell transplant (HCT), versus Conventional Care.   "
47410|NCT02665052|"     Loss of arm use and strength are common problems after stroke that greatly affects     independence in activities of daily living. Arm rehabilitation using robot-assisted     repetitive task training has shown to improve motor recovery. However, this type of exercise     cannot be done at home as these devices are large and expensive. This study will test whether     a more portable, less costly, non-robotic repetitive training device called Bilateral Arm     Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a tele-rehabilitation     format will lead to improvement in arm and hand use in patients with chronic stroke. The     investigators plan to test the effectiveness of home based tele-rehabilitation with the     BATRAC compared to a clinic based approach.   "
47411|NCT02665039|"     This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine     and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal     function.   "
47412|NCT02665026|"     The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy     closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and     safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical     resection of rectal carcinoma). This study was expected to demonstrate that the early     preventive ileostomy closure after total mesorectal excision of rectal cancer does not     increase the risk of complications.   "
47413|NCT02665013|"     This trial will assess the effectiveness of a tailored message intervention on decreasing     infant undervaccination.   "
47414|NCT02665000|"     1.1 Aim The investigators wish to validate a structured training program for junior residents     to enhance their learning curves in performing laparoscopic appendectomy.      1.2 Hypothesis To introduce a structured laparoscopic appendectomy training program and     validate its efficacy with the validated GOALS scoring system.   "
47415|NCT02664987|"     This study is planned to investigate the pain control status in cancer patients in 6 South     East Asian countries through evaluation of prescription pattern of analgesics, satisfaction     of pain control, quality of life and assessment of the adequacy of pain control and     relationship among these factors in cancer patients with pain. Cancer pain is undermanaged     and it is hoped that this study will be used as a reference for effective cancer pain     management in these countries.   "
47416|NCT02664974|"     Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized,     clinical trial.      The aim of this study is to evaluate the efficacy of home enteral nutrition on the     nutritional status, the quality of life and tolerance to chemotherapy, in malnourished     patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach,     pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition     (HEN, treatment group) or nutritional counselling (control group).   "
47417|NCT02664961|"     The purpose of the study is to determine the overall response rate of single agent TRC105 and     the combination of TRC105 and bevacizumab in patients with refractory GTN (including     choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic     tumor (ETT)). Up to 30 patients will be treated.   "
47418|NCT02664948|"     The study is a quasi-randomized controlled trial conducted in a Danish University Hospital     including older patients admitted to Emergency Department (ED). 'Early geriatric follow-up'     is a multidisciplinary geriatric service provided to older patients who are discharged to     their home. They receive hospital-visits by a multidisciplinary team no later than 24 hours     after discharge (except on sundays). The team is consisting of a physician and a nurse both     with geriatric expertise. The physician is responsible for the clinical patient care. The     team is available seven days per week/12 hours per day and 24 hour on-call. In the patient's     home, the team has the possibility to perform diagnosing and treatment by assessments,     medication review, blood tests, subcutaneous fluid therapy, blood transfusions, intravenous     antibiotics, rehabilitation and social arrangements. A discharge hand-over supports the     caregivers and the GP.   "
47419|NCT02664935|"     The trial consists of a series of parallel multi-centre single arm phase II trial arms, each     testing an experimental targeted drug in a population stratified by multiple pre-specified     actionable target putative biomarkers. The primary objective is to evaluate whether there is     a signal of activity in each drug-(putative)biomarker cohort separately. A Bayesian adaptive     design is adopted to achieve this objective and statistical details are given in the     Protocol.   "
47420|NCT02664922|"     The purpose of this study is to compare different combinations of anesthetic drugs (cause     loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient     comfort for cardiac electrophysiology procedures. In addition, the investigators are studying     the different anesthetic combinations to determine the best approach in terms of     identification and treatment of arrhythmias.   "
47421|NCT02664909|"     This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1     gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion     following hip hemiarthroplasty surgery.   "
47902|NCT02658617|"     The findings may guide future investigations on novel therapeutic targets in depressive     subjects. Based on the depicted link between personality traits and altered brain metabolism     and function, the latter might be used as supporting objective measures and possible     biomarkers for increased depression risk.   "
47422|NCT02664896|"     Recently, the medical community has learned damage to the knee joint may be one of many     possible reasons for pain in knee osteoarthritis. Psychological factors and other aspects of     brain function seem to play an important role in the pain experience. Although research     studies have examined these factors on an individual basis, no study has examined all of     these factors in the same population. Furthermore, some measures of brain function- having to     do with perception of the painful body part- have yet to be examined in knee osteoarthritis.     The investigators plan to study many of these variables in a group of people with knee     osteoarthritis, as well in some healthy controls (without knee pain), in order to establish     the relative importance of these measures in contributing to pain, as well as validate new     measures of perception in people with knee osteoarthritis. We also plan to use a statistical     tool- known as latent profile analysis- to look at subgroups of knee osteoarthritis pain. The     hypothesis is that different people experience pain in knee osteoarthritis for different     reasons. This study will be the first study to use all of these different variables- which     can be reproduced in a clinical setting- to look for different subgroups of knee     osteoarthritis pain. Ultimately, the goal is to help clinicians better prioritize and target     interventions to individual patients. The investigators believe this will lead to better     outcomes and fewer treatment complications currently associates with pharmaceutical and     surgical interventions that are widely used to treat knee osteoarthritis.   "
47423|NCT02664883|"     This pilot research trial studies the use of the Myeloid Derived Suppressor Cells Clinical     Assay in finding and monitoring kidney cancer. Studying samples of blood and urine from     patients with kidney cancer in the laboratory may aid doctors in the early detection of     cancer, monitor tumor response to therapy, detect the presence of occult spreading of     disease, and identify early return of disease.   "
47424|NCT02664870|"     Osteoarthritis is a condition that causes joints in the human body to deteriorate over time.     This condition affects more than 250 million people around the globe. Currently, the goal of     treating osteoarthritis involves reducing the severity and pain that results from the     disease. The ultimate goal of this study is to identify patients with pre-arthritic joints     (before symptoms or disease characteristics appear) in an effort to find and use treatments     that stop or slow the disease. Joints are filled with a naturally occurring liquid known as     synovial fluid. Molecules (biomarkers) and genetic expression of various cell types within     synovial joint fluid may serve as measures of onset and progression of osteoarthritis. These     samples have the potential to improve diagnosis, classification, and treatment, possibly     changing the natural history of this debilitating disease. The purpose of this study is to     develop a collection of synovial fluid samples from the shoulder, hip and knee for the     analysis of biomarkers and cellular and genetic components therein to better understand the     pre-arthritic joint, progression to disease, and response to interventions.   "
47425|NCT02664857|"     In this study, effect of vitamin D supplementation on postoperative pain and     sedation-agitation will investigate. Children with mental motor retardation between 7-17 age     which dental treatment will be performed under general anaesthesia will be included in this     study. 600 IU vitamin D will apply to group D per orally during 12 weeks. Group P will not     take anything during 12 weeks. At first day and end of the 12 weeks, serum vitamin D,     calcium, alkaline phosphatase, terminal telopeptide C(β-CTX) level will evaluate. At the end     of the 12 weeks general anaesthesia will be performed for teeth check up, flouring, scaling     polishing, tooth extraction, filling applications, amputations, root canal treatment. After     then postoperative pain, sedation and agitation will be evaluate. All data will be     statistically evaluate at the end of the study.   "
47426|NCT02664844|"     In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (>     70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner     the same day. The effect on food intake of the distribution of this exercise into two     sessions during 24h remains to be determined. In addition, a multidisciplinary load of     obesity generates a loss of body weight in the short term, which we do not know the effects     on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of     muscle exercise is unknown.   "
47427|NCT02664831|"     This is a prospective, observational study of inflammatory mechanisms and lipid metabolism     after resuscitation from cardiac arrest during targeted temperature management. Investigators     are focusing on elucidating two biochemical pathways. The first is neuregulin-1 (NRG-1), a     growth factor regulating cell resistance to oxidative stress, cell survival and     proliferation. The second relates to lipid peroxidation and pro-inflammatory lipid     precursors. Participants will undergo blood sampling during 7 days following cardiac arrest,     and analyses performed. Patient characteristics, clinical circumstances, and outcomes will be     recorded and their associations with these inflammatory pathways characterized.   "
47428|NCT02664818|"     The purpose of this study is to assess clinical characteristics, treatment, and outcome of     patients hospitalized with heart failure in China and compared those with other registries   "
47429|NCT02664805|"     To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249     ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.   "
47430|NCT02664792|"     To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the     Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for     staging of non-small cel lung carcinoma.   "
47431|NCT02664779|"     Background: Arrhythmia recognition is a fundamental skill for the provider of advanced life     support (ALS). Acquire it is difficult, leading to the birth of systematic methods in an     attempt to simplify and optimize, however, it has not compared the effectiveness among the     three methods with more evidence among professionals with varying degrees of medical training     (ALS Workshop participants).      Objective: To determine and compare the effectiveness of the three most widespread and with     more evidence systematic methods (10, 6 and 4 steps) for the recognition of arrhythmias in a     short-term and its perceived easiness among ALS workshop participants.      Methods / design: Educational Cuasi experimental trial with pre and post intervention     measurement, blind, with randomized allocation, in 84 ALS workshop participants. Three     systematic methods to recognize arrhythmias will be taught and their effectiveness to     diagnose in a short-term and its perceived easiness will be measured and compared.   "
47434|NCT02664740|"     The primary objective of this study is to compare the efficacy of standard treatment     associated with a topical anti-staphylococcal bacteriophage cocktail versus standard     treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or     susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface     area (%) at 12 weeks.   "
47435|NCT02664727|"     The purpose of this research is to examine the effects of exercise of different intensities     on psychological, physiological, biochemical, physiological and alcohol-related parameters in     individuals with alcohol use disorders (heavy drinkers and alcoholic patients) in order to     investigate possible biochemical mechanisms by which exercise may be a healthy alternative to     alcohol abuse. For that purpose, a control group of individuals that do not exceed the limits     for moderate alcohol use will be included.   "
47436|NCT02664714|"     The aim of this study is to evaluate if the training of pelvic floor muscles, which     associates an individualized treatment progressing to a group treatment, would be more     effective than an individualized training only or groups only.      Methods: Randomized controlled study which will be done from January to December of 2016, on     Laboratory of Women's Health Research, Federal University of São Carlos-SP, Brazil.      Inclusion criteria: women with stress UI, older than 18 years old. The sample size     calculation was performed using the GPower Software (3.1.5, Germany) and it was estimated a     sample of 30 women in each group. The volunteers will be assessed before the intervention by     a urinary symptoms evaluation form, King's Health Questionnaire, miccional diary, PERFECT     scheme and perineometry.      After the evaluation will be performed the randomization of the volunteers by a blinded     investigator and the volunteers will be allocated into three groups:      Group 1: Individualized Training Group 2: Individualized training with progression to group     training Group 3: Group training only      For all groups it will be used the same protocol that was prepared according to the     recommendations of the American College of Sports Medicine. Later, volunteers will be     reassessed after 12 treatments, three months and six months (from the discharge date). It     will be added in the reassessment the Self-efficacy Scale for Pelvic Floor Exercises     Practice.      Primary outcome: severity measures of the King's Health Questionnaire.      Secondary outcome: miccional diary, PERFECT scheme, perineometry and Self-efficacy scale for     Pelvic Floor Exercises Practice. Data normality will be tested by the Shapiro-Wilk test (SPSS     19.0). The comparison between the evaluations will be performed by ANOVA, and the comparison     between groups will be performed by Student t-test (independent measures). In order to     measure the practical significance of the data, the effect size and the confidence interval     (CI) will be calculated. A 5% significance level will be assumed. This study was approved by     the Research Ethics Committee of the Federal University of São Carlos, São Carlos- SP, Brazil     (Protocol 1207393).   "
47437|NCT02664701|"     The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of     Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual     Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months     post-psychotherapy in adults admitted to inpatient care for suicide attempts.   "
47438|NCT02664688|"     The purpose of this study is to compare the effectiveness of pain control and functional     improvement in patients with degenerative spondylolisthesis treated with lumbar     stabilization exercises vs flexor exercises (williams exercises)   "
47447|NCT02664571|"     The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ:     FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis     in non-demented patients with that observed in healthy subjects, patients with ACA and with     lobar hematoma(s) and patients with Alzheimer's dementia without MRI signs in favor of ACA.   "
47439|NCT02664675|"     Recent data found that peri-implantitis may differ from periodontitis at the histological     level in terms of extent and composition of the cellular components. From human biopsies, it     has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger     proportion of granulocytes and macrophages in peri-implantitis lesions compared to     periodontitis lesions. Following experimental peri-implantitis, it has been observed a     continuing bone loss around dental implants after ligature removal; whereas, such a     progression was not observed around teeth after cessation of the experimental periodontitis.     The factors influencing the recruitment and the activation of osteoclasts in both diseases     have not been compared yet.      Hypothesis : The more rapid and more severe alveolar bone destruction occurring in     peri-implantitis compared to periodontitis is due at least in part to differences in the     inflammatory process in these diseases.      Aim: to study the cytokine profile produced by gingival explants from periodontitis or     peri-implantitis sites and to test the consequences on alteration of bone remodelling     activity using in vitro approach.      Materials and methods The investigators will establish a collection of human gingival samples     from patients undergoing surgical treatment of periodontitis or peri-implantitis. The     investigators will test pro-inflammatory cytokines and chemokines release and consequences on     osteoclast differentiation and activity.   "
47440|NCT02664662|"     For the past few years, the survival rate of breast cancer improved due to the advancement of     surgery techniques and popularization of cancer screening. However, prolonged survival rate     is definitely not equal to achieving a sound quality of life among breast cancer survivors.     The health status of cancer survivors might deteriorate according to the severe side effect     of multiple therapies.      Health literacy is the ability to access, understand, evaluate and communication information     as a way to promote and maintain health. Therefore, good health literacy raise the quality of     life of breast cancer survivors by a good competence in searching and using medical     resources. Moreover, how to improve health literacy after cancer surgery becomes an important     part recently. Even if the most fundamental concept has promoted for decades, the clinical     workers still use the identical education of medical care after surgery for breast cancer     survivors. However, the identical education is not appropriate for each of patients. In fact,     each of breast cancer survivors has the different cancer stage leading to accept different     therapy and producing different side effect. Besides, the background and the role of life are     very different from each other. Because of the above reasons, the aim of the study is going     to develop a tailored rehabilitated education, which fit for each breast cancer patients     after surgery in clinic. At the same time, the health literacy ability might be improved by     tailored rehabilitated education. When health literacy level is raised, the breast cancer     survivors have a good quality of life and beautiful health status.   "
47441|NCT02664649|"     ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial.      The objective of this study is to demonstrate superiority of a strategy of anticoagulation     with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who     have undergone a successful TAVI procedure.      The randomization is stratified according to the presence or not of a mandatory indication     for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or     DVT/PE).   "
47442|NCT02664636|"     The main objective is to develop models for the cortical reorganization of motor areas and     inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the     fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to     correlate the latter with the early phases of motor recovery over the same period, as     measured by the test Fugl-Meyer.   "
47443|NCT02664623|"     The main objective of this study is to measure effectiveness at 6 months of personalized     dietary advice versus dietary counseling via delivery of a standard advice sheet for     optimizing dietary calcium intake (assessed by a food survey based on CIQUAL* data) in MS     patients with ambulatory monitoring.      *CIQUAL Data: Table of nutritional food composition available on the ANSES (National Agency     for Sanitary Security of Food, Environment and Labour) website, published by the Observatory     of the Nutritional Quality of Foods. This table includes 1,500 sheets of 58 nutritional     components. The data is integrated into the software for calculating ingesta (DATAMEAL) at     the Nîmes University Hospital.   "
47444|NCT02664610|"     One of the most powerful predictors of stroke is hypertension, with estimates of     approximately 33% of adults in the United States experiencing this condition. Hypertension is     significantly more prevalent in African Americans compared to European Americans.     Importantly, hypertension is a modifiable stroke risk factor.      This proposal will use a community-based participatory research approach to perform a     randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure     in an urban African American community in Flint, Michigan.   "
47445|NCT02664597|"     Background : About 25% of adnexal masses remain indeterminate after transvaginal     ultrasonography, as evidenced by the published literature. According to a multicenter study     conducted in France by Huchon et al., surgery is mainly indicated based on tumor size and     ultrasonographic appearances and a high rate of benignity is finally found at pathology     (83.3%). MRI is the most accurate second-line imaging technique for characterizing adnexal     masses with an accuracy>95%. However, among physicians, a debate exists on the relevance of     MR imaging to characterize adnexal masses possibly due to the absence of standardization of     the MR report. In 2013, the first MR scoring system for adnexal masses named ADNEXMR score     was developed and found to be accurate, with an AUROC>0.94 to distinguish benign from     malignant adnexal masses. Indeed, our hypothesis is that ADNEXMR score that relays the     radiologist's suspicion of malignancy to clinician has the potential aim of improving patient     management, in particular by limiting the number of patients undergoing inappropriate     surgery.      Main objective: To compare the rate of inappropriate surgery that occurs when patients are     managed according to the therapeutic strategy based on ADNEXMR score with the therapeutic     strategy performed in clinical routine.      Primary endpoint: The rate of inappropriate surgical intervention during the two first months     after MR imaging (i.e. unnecessary diagnostic surgery for benign lesions and incomplete     staging for borderline or invasive cancer).      Study design:        -  The study is a prospective multicenter randomized diagnostic study. 606 patients will be          included by 8 hospitals (16 centers).        -  Total duration of the study is 36 months with one year for patient inclusions.        -  At D0, following informed written consent, patients will be randomized in one of two          groups (intervention group or control group). In the intervention group, patients will          undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including morphological          sequences (T2, T1 with and without fat suppression and T1 after dynamic gadolinium          injection) and functional sequences (perfusion and diffusion-weighted sequences).          Prospectively, a senior radiologist analyzes the different MR criteria to characterize          adnexal masses. The reader will classify the mass using ADNEXMR SCORING system and the          patient will be managed according to the score. In control group, the complex adnexal          mass will be managed according to the standard strategy and treatment plan routinely          used by the multidisciplinary team. Clinical, biological, ultrasonographic and/or MR          data and the type of treatment will be recorded. If a surgery is required, surgical          procedure will be performed within the two months after initial diagnostic imaging (as          routinely recommended).      At M6/M12, follow-up will be performed. If the lesion has increased or changed with     suspicious criteria, surgery will be performed as routinely recommended in both groups.      At M24, adnexal masses status will be recorded by clinical and imaging follow up.   "
47446|NCT02664584|"     Background:      Cardiovascular disease (CVD), osteoporosis and dementia are chronic diseases of ageing that     impact adversely on the lives of those affected and have major health, social and economic     consequences. A number of factors are considered to be implicated in these diseases, ranging     from the more established factors to those that are less well recognised. Lifestyle factors     such as diet, body weight, smoking, physical activity and years of education are acknowledged     as risk factors for the development of these chronic diseases of aging. Emerging research     suggests that elevated homocysteine and/or sub-optimal status of the metabolically related     B-vitamins (folate, vitamin B12, B6 and riboflavin) may be associated with a higher risk of     age-related disease. The interplay between relevant genetic and nutrient factors     (gene-nutrient interactions) is considered to be highly relevant in the development (and     prevention) of chronic diseases of ageing, however this relatively new area of research is as     yet poorly understood. The collection of clinical, lifestyle, nutritional and genetic data on     large numbers of patients would permit the investigation of those nutrients which interact     with specific genes to increase the likelihood of a person developing chronic diseases of     ageing.      Aim:      The aim of the TUDA study is to collect detailed clinical, lifestyle, dietary, genetic and     biochemical data to investigate gene-nutrient interactions (particularly from the perspective     of the B-vitamins and vitamin D/calcium) in the development of CVD, osteoporosis and dementia     by studying older adults exhibiting the early stages of these common diseases, namely     hypertension, low bone mineral density, and early memory loss, respectively.      Secondary aim (follow up TUDA investigation):      The aim of this longitudinal investigation is to re-assess clinical, nutritional, genetic and     biochemical factors in relation to the progression of disease outcomes in TUDA study     participants, in subsequent years after initial investigation.      Study design:      A total of 6000 non-institutionalised older Irish people aged over 60 years with early     predictors of either dementia, stroke and osteoporosis (namely early memory loss, high blood     pressure and low bone mineral density, respectively) recruited from three centres (St James's     Hospital Dublin, Ulster University Coleraine and The Clinical Translational Research and     Innovation Centre (C-TRIC), Londonderry) across Ireland. Non-fasting blood samples were     collected from all subjects and routine blood biochemistry profiles and biomarkers of     relevance to B vitamin and vitamin D status were measured. Supplement use was recorded and a     targeted food frequency questionnaire was used to record dietary intakes of specific vitamins     of interest (folate, B12, B6, riboflavin and D) from major food sources, particularly     fortified foods. Physiological function tests including blood pressure, bone health (DXA     scans) and cognitive function tests and anthropometric measures were also taken.   "
47448|NCT02664558|"     Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World     Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening.     This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind,     placebo controlled study comparing ubenimex with placebo in patients with PAH (WHO Group 1)     and have a WHO/New York Heart Association (NYHA) Functional Classification (WHO/NYHA-FC) of     II or III. The Primary Objectives for the study are:        -  To evaluate the efficacy of ubenimex in patients with PAH (WHO Group 1).        -  To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH.   "
47449|NCT02664545|"     The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate     Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate     ligament (ACL) injuries, ACL reconstruction.   "
47450|NCT02664532|"     The purpose of this prospective open labeled randomized study was to compare the     laryngoscopic glottis view as well as ease of intubation between the two blades in     routine intubations in non-difficult airways.   "
47451|NCT02664519|"     Patients with chronic kidney disease (CKD) experience fatigue and exercise intolerance.     Increased oxidative stress in CKD may be a contributing factor. The role of impaired muscle     blood flow regulation has not been fully explored. The investigators hypothesize that     functional sympatholysis is exaggerated in CKD and this is associated with increased     oxidative stress. The investigators also hypothesize that exercise training will improve     functional sympatholysis and oxidative stress   "
47452|NCT02664506|"     The aim of this research is to translate a theory of the cognitive relationship between     verbal short--term memory (STM) and word processing impairments in aphasia to treatment     approaches for language impairment in aphasia. It has been proposed that the co-occurrence of     these impairments is due to a disruption of cognitive processes that support both abilities:     maintenance of activated semantic and phonological representations of words, hereafter the     'activation--maintenance hypothesis'.      This hypothesis will be tested in the context of a treatment approach that aims to improve     word processing and verbal STM abilities.   "
47479|NCT02664155|"     In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC)     anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is     associated with an increased risk of thromboembolic and bleeding complications compared to     patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be     at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate     renally impaired patients were poorly represented and patients with severe renal     insufficiency not at all. So no dose reduction was considered.      Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally     impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in     patients with moderate and severe renal insufficiency.      We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE     patients with moderate or severe renal insufficiency in terms of net clinical benefit     (recurrent VTE and major bleeding) at 3 months.   "
47453|NCT02664493|"     -  Several studies have shown that about 30% of transplanted kidneys with stable function          present with tubule-interstitial mononuclear cell infiltration in protocol biopsies and          therefore meet criteria for acute rejection. This subclinical rejection (SCR) has also          been correlated with subsequent chronic allograft nephropathy and allograft dysfunction.        -  The Banff scheme defines the minimal threshold for acute T-cell mediated rejection as          infiltration of 25% or more of the renal cortex with five or more mononuclear cells in a          focus of tubulitis or intimal arteritis (histological indices i2t2 or v1) and refers to          borderline changes as those with insufficient for a diagnosis of acute T-cell mediated          rejection, including mild to moderate (<50%) cortical infiltration and one to four          mononuclear cells per tubule in cross section (i1t1 or i2t1)        -  No consensus for the treating patients with borderline changes has been reached.          Borderline changes with graft dysfunction are occasionally routinely treated with          steroid pulse and, whereas subclinical borderline changes are simply 'ignored'.          Particularly, a previous study demonstrated that most cases designated borderline by          histopathology are found to be non-rejection by molecular phenotyping        -  The aim of this study is to investigate the effect of early steroid pulse therapy for          the reduction of acute rejection episode during the first year after renal          transplantation in the patients who will show subclinical borderline changes at 2-week          protocol biopsy.   "
47454|NCT02664480|"     Investigators aimed to investigate whether there is an association between ovulation and     salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group     of reproductive women.   "
47455|NCT02664467|"     In a 3 years longitudinal, observational, multicentre study, about 500 women will be     recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after     delivery. The primary aim of the present study is to systematically explore and characterize     risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist     actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of     potential markers during the perinatal period (Life-ON study). Secondary aims are to explore     the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to     investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether     a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3).      The characterization of specific predictive and risk factors for PND may substantially     contribute to improve preventive medical and social strategies for the affected women. The     study results are expected to promote a better understanding of the relationship between     sleep disorders and the development of PND and to confirm, in a large sample of women, the     safety and efficacy of BLT both in prevention and treatment of PND.   "
47473|NCT02664233|"     In order to facilitate the evidence-based goal setting and self-monitoring intervention into     the diabetes education practice, the investigator proposes to use Chronicle Diabetes, an     electronic system provided available to the American Diabetes Association diabetes education     programs, to set patient diet and physical activity goals, and connect patient     self-monitoring information collected from smart phones and fitness trackers to Chronicle     Diabetes system to facilitate educators' monitoring of patient adherence to their goals.   "
47456|NCT02664454|"     Older patients account for around 10% of the population, of which 57% have a long-term     illness, and 33% were admitted in the past year.      Geriatric assessment (GA) is a multidimensional assessment of general health status that can     help identifying deficiencies and followed by a personalized care plan.      Assessment and management of elderly patients is a daily concern for the general practitioner     (GP) but conflicting results have been reported so far relating to the clinical impact of GA     when applied in the primary care setting.      This study protocol aims to assess the effect on morbi-mortality of a complex intervention in     patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that     a GA adapted to primary care, followed by a personalized care plan and combined with     successful interprofessional collaboration can improve clinically relevant outcomes in     elderly patients with chronic conditions such as one-year overall mortality, unplanned     hospital admission, emergency visits, or institutionalization.      The CEPIA study will also help addressing the issue of whether an improved benefit could be     achieved from a systematic nurse-led or a case-by-case GP-led GA.   "
47457|NCT02664441|"     The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist     exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic     parameters in a double-blind, placebo-controlled 36 week randomized trial with an 18 week     open label extension. Following baseline testing, 48 patients will be randomly assigned with     equal allocation to ExQW or matching placebo injection for 36 weeks, followed by an 18 week     open label extension during which all patients receive ExQW. Changes of weight status, body     composition, free-living total daily energy expenditure (EE) by doubly labeled water (DLW),     activity by acetimetry, energy intake (questionnaires and food diary), as well as glucose     tolerance and hormonal parameters of energy homeostasis and insulin resistance will be     assessed before treatment and at the end of the placebo-controlled phase (week 36). Activity,     metabolic outcomes, energy intake will be also assessed at study week 18 (mid treatment of     randomized study), as well as week 54 (end of open label treatment).   "
47458|NCT02664428|"     Study hypothesis: Diet integrated with food prepared with olive, buckwheat, peas and chestnut     flour as in PreBIOil product combination can modify the gut microbiota and the cholesterol     metabolism.      Primary objectives of the study are to assess whether the test product to be able to change:        1. fecal microbiota profile;        2. Plasma cholesterol LDL, total, total LDL and HDL ratio;        3. plasma triglycerides;        4. Apolipoprotein ApoA-I, ApoB, and Lp.      Secondary objectives of the study are:        1. anthropometric indices;        2. secondary metabolites of polyphenols in human biofluids;        3. mass spectrometry plasma and urine metabolite profile;        4. blood glucose and fasting insulin levels; 5,6) C-reactive protein (PRC or hsPRC);      7) urinary isoprostane F2; 8) oxidized LDL in plasma.      Study Design: placebo-controlled, randomized, double-blind parallel trial.      Inclusion criteria: Aged 30-65 years; BMI 20-29,9 kg/m^2. Total Cholesterol 180-240 mg/dl      Exclusion criteria: Fasting blood glucose >150 mg/dl; triglycerides >500 mg/dl; uncontrolled     hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long     term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic     substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco     smoking.      Methodology: Determination of eligibility: for each volunteer aged between 30 and 65 years,     will undergo to clinical and biochemistry evaluation. Clinical visit, clinical tests, and     blood drawing will be performed after an overnight fasting at visit T-1 at the Casa di Cura     Eremo di Arco (TN). In this T-1 visit the eligibility will be established and the     participants will be randomized to receive supplementation with either PreBIOil biscuit     (90g/day) or Control for 8 weeks in a double-blind manner. Clinical tests, blood drawing, and     stool and urine collection will be performed during visits at the beginning and end of each     treatment period (T0 and T1). A 4 day-food diary record will be collected before visits T0,     at the beginning of T0 and before T1.      Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food     questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL     cholesterol, oxidized LDL, serum glucose and insulin, C-RP, Apolipoproteins, Isoprostane;     urinary and plasma metabolite profiling; fecal microbiota analysis.      Safety assessments. Adverse events registration.      Statistical analyses. The differences between the two group will be evaluated with univariate     and multivariate statistical methods. The medium before and after the intervention will be     compared with the General Linear Model (ANOVA) for repeated measures or for paired data.     Simple and multiple linear regressions will be performed to determine the relationships     between independent variables; also we will run the t-test to evaluate differences in     compliance detected in the types of supplementation. The results are expressed as mean +/-     SEM and the differences will be considered significant when P <0.05.      Duration: Subjects will make three visits (visit T-1, beginning visit T0, and end of     treatment period visit T1, week 8 from T0). The treatment duration is 8 weeks; a daily     portion of about 90 g of biscuit is introduced.   "
47459|NCT02664415|"     The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody     (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption     (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.   "
47480|NCT02664142|"     General anaesthesia (GA) is, according to many definitions, the greatest gift presented to     the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of     anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it     is necessary to observe the clinical condition of the patient, and at the same time monitor     the patient's overall condition. With the currently available options of GA management (e.g.     use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in     combination with various methods of topical anaesthesia) the importance of methods measuring     the depth of GA increases. The depth of GA may be defined as a continuous progressive     decreasing of the central nervous system, together with a decreased reactivity to stimuli. In     the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening during     a surgical procedure may result in significant psychological complications (e.g.     post-traumatic stress disorder), and the patient may suffer from a serious long-time     disorder.   "
47657|NCT02661815|"     Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12     months of prior treatment that includes Platinum Chemotherapy are invited to take part in     this study. This research study is studying a combination of a new chemotherapy drug called     Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a     possible treatment for this diagnosis.   "
47460|NCT02664402|"     Background:      People undergo many changes when they have a life-threatening illness. Their values may     change. They may have less fear of illness and death. They may become more spiritual.     Researchers made a questionnaire called HEALS (Healing Experience During All Life Stressors).     They want to use it to better understand these positive changes. They hope to provide better     care for people with serious illnesses.      Objectives:      To develop the HEALS tool to better understand psycho-social-spiritual healing in people with     serious illnesses. Also, to find out how palliative care services help people handle their     illness or stress.      Eligibility:      Adults at least 18 years old at least 91 days after being diagnosed with a life-threatening     illness. They must be getting:      Inpatient or outpatient palliative care at NIH Clinical Center OR      Inpatient palliative care at Suburban Hospital OR      NIH outpatient palliative care provided at Mobile Medical Care Clinic      Design:      Participants will be screened with questions to make sure they are eligible.      Participants will have 1 individual research session. This will be at the NIH Clinical     Center.      Participants will be interviewed by a research team member. They will be asked about changes     in a person s way of living that might happen during or after a serious illness.      Participants will be asked for their thoughts and opinions about the questions. They will be     asked what ideas they may have to make the questions better.      Interviews will be audiotaped.      Participants will be asked some questions specific to their care location and team. These are     to better understand how their services are helping participants.   "
47461|NCT02664389|"     Despite relevant clinical and/or familial presentations suggesting a hereditary     predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic     analysis based on the phenotype are often non contributive. As somatic cancer genes are     limited, the hypothesis is that the targeted next-generation sequencing of 200 genes,     selected for their implications in cancers may contribute to the understanding of many     selected patients' presentation by the identification of germline deleterious mutations, and     may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset     breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.   "
47462|NCT02664376|"     The goal of this study is to determine the prevalence of sarcopenia in a geriatric hospital     ward.      Sarcopenia is defined by a loss of muscle mass, loss of muscle strength and loss of muscle     quality. It is a geriatric syndrome that, to this date, is not systematically tracked in     clinical practice.      In order to detect sarcopenia, the investigators will use the operational definition proposed     by the European Working Group (EWGSOP) involving the measure of three parameters, namely the     speed of walking, the muscle strength and the measurement of the muscular mass.   "
47463|NCT02664363|"     Newly diagnosed glioblastoma subjects who are eligible will be enrolled following surgery to     remove the brain tumor. They will then undergo a leukapheresis to harvest cells for the     generation of the study drug, Epidermal Growth Factor variant III Chimeric Antigen Receptor     (EGFRvIII CAR) T cells prior to beginning standard of care (SOC) radiation therapy (RT) with     temozolomide (TMZ). Once SOC RT with TMZ is completed, subjects will return for the post-RT     brain imaging assessment, and if stable will start post-RT TMZ cycles. During the 3rd cycle     of post-RT TMZ, the EGFRvIII CAR T cells will be infused in dose escalation cohorts.     Following a one month delay between cycles, the subject will resume post-RT cycles of TMZ and     be monitored with blood work and brain imaging as per SOC. Once the maximally tolerated dose     (MTD) is reached in the dose escalation cohorts, an expanded cohort of 12 subjects will be     enrolled to obtain a more precise estimate of the probability of unacceptable toxicity and to     track the EGFRvIII CAR T cells using 111 Indium (111In) labeling. Computed Tomography (CT)     will be done on days 1, 5, and 10 post-infusion to determine intracerebral (IC) localization.   "
47464|NCT02664350|"     Pain is one of the most burdensome symptoms associated with cancer and its treatment, and     opioids are the cornerstone of clinical pain management in cancer patients. Yet, individual     patient responses to opioids vary widely, and the patient's genotype contributes to this     variability. Specifically, cytochrome P450 2D6 (CYP2D6) genotype has important relevance for     response to opioid analgesics that depend on CYP2D6 for bioactivation. Poor metabolizers     (PMs) have lower concentrations of active metabolites of codeine (morphine), tramadol     (O-desmethyltramadol), oxycodone (oxymorphone), and hydrocodone (hydromorphone), compared to     extensive metabolizers (EMs). Morphine and O-desmethyltramadol have 200-fold greater affinity     for the µ-opioid receptor than the parent compound, whereas oxymorphone and hydromorphone     have 40-fold and 10-fold higher receptor affinity compared to their parent compounds,     respectively. Consequently, PMs may fail to derive pain relief from these opioids compared to     EMs. Interestingly, the occurrence of side effects may not differ between PMs and EMs so that     while PMs may get little to no pain relief from certain opioid analgesics, they may still     experience troublesome adverse effects. Intermediate metabolizers (IMs) are also expected to     have reduced analgesic response based on their significant reduction in enzyme activity.     Conversely, individuals with the UM phenotype may have toxic concentrations of active opioid     metabolites, with reports of life-threatening toxicity and death. The µ-opioid receptor gene     (OPRM1) is the primary binding site for endogenous opioid peptides and opioid analgesics, and     may have additional contributions to opioid response. The investigators propose to examine     the effect of CYP2D6 genotype-guided pain management on cancer pain control in study     participants and the additional effect of the OPRM1 genotype on response to opioids.   "
47465|NCT02664337|"     This study is an observational study to test and validate a questionnaire and statistical     model used to determine patient preferences regarding treatment for any one of 11     musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and     femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture,     patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia,     and proximal humerus. This study aims to understand how multiple treatment variables,     including pain, rehabilitation time, cost, and choice of surgical versus non-surgical     intervention, impact patients' decision-making processes and ultimate choice of treatment.   "
47466|NCT02664324|"     The primary objective of this feasibility study is to evaluate the functionality (e.g., as     defined by the primary endpoints) of the fully integrated Multiple Sclerosis Performance Test     (MSPT) device, when used by unsupervised participants with MS, or related conditions, with a     broad range of disability, in multi-clinical-care environments. Secondary objectives include:     Participant perception of usability of device; Participant satisfaction with the device;     Ascertain the impact of different clinical environments on device usability; Ascertain impact     of assistive devices in usability of device; Ascertain functionality of Bluetooth remote as     compared with manual timing.   "
47467|NCT02664311|"     This is a randomized prospective study comparing outcomes of pulmonary vein isolation using     conventional and jet ventilation.   "
47525|NCT02663544|"     This randomized controlled feeding trial aims to determine whether the consumption of     different amounts and types of dairy products affects blood sugar regulation and     cardiometabolic health in men and women with the metabolic syndrome.   "
47468|NCT02664298|"     Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic     rehabilitation in which a prosthesis is supported by osseointegrated implants, was first     introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to     removable prosthesis. However, for patients with a severely atrophic maxilla or mandible,     cranial bone grafting of the jaw is required to increase bone width and height necessary for     implant insertion. An active collaboration between the surgeons from the Oral and     Maxillofacial Department and the prosthodontist from the Department of Dentistry has been     established for continuous quality improvement of the concept of (immediate/delayed) implant     loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone.      The investigators aim to develop a prospective database registering (immediate/delayed)     implant loading data of all patients eligible according to the protocol. Patient     demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected     during consecutive visits within the framework of routine practice.      Development of a database registering immediate functional loading data secondary to cranial     bone-grafting of a severely atrophic jaw, will provide more information about potential     patient, surgical and prosthetic factors influencing long-term biological and mechanical     stability, as well as patient satisfaction. Moreover, registration of those results could     function as a measurement of quality of care, and could be used for sample size calculation     for future large prospective trials.   "
47469|NCT02664285|"     The aim of this study is to determine the surgical site infection rate and the patient's     satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue     after cesarean delivery in women with diabetes mellitus.   "
47470|NCT02664272|"     Multicenter, observational study to evaluate if there is a difference between the final     position of the femoral stem and the last trial rasp when using the SL-PLUS™ MIA Ti/HA     femoral hip stem with the appropriate set of instruments.   "
47471|NCT02664259|"     The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin     bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial     ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without     radiographic fluoroscopy.   "
47472|NCT02664246|"     This review article have included about ten thousand patients undergoing percutaneous     coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new     risk factors and the protecting methods for these factors.   "
47475|NCT02664207|"     The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to     pregnant women with one of the former surgery exclusion factors        -  A BMI of 35-40 kg/m2        -  Diabetes; patients will require good glycemic control        -  History a previous preterm birth, as long as it was followed by a full term birth        -  Structural abnormality in the fetus; abnormality must be minor, not increasing the risk          of prematurity. For example cleft lip and palate, minor ventricular septal defect,          pyelectasis.        -  Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that          is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or          alloimmunization with negative fetal red blood cell antigen status determined by          amniocentesis.      We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including     these factors. Prenatal clinical and outcome information will be collected; safety and     efficacy will be evaluated   "
47476|NCT02664194|"     To evaluate and improve the safety and efficacy of hypothermia as an adjunctive therapy to     percutaneous coronary intervention in patients with acute myocardial infarction.   "
47477|NCT02664181|"     The purpose of this study is to assess whether treatment with the study drug     tetrahydrouridine-decitabine (THU-Dec) in combination with nivolumab is more effective than     treatment with nivolumab alone in patients with NSCLC.      Decitabine is an investigational (experimental) drug that works by depleting DNA     methyltransferase 1 (DNMT1). DNMT1 is an enzyme, or protein that causes chemical changes,     often increased in cancer. Blocking DNMT1 has been shown to reduce tumor formation.     Decitabine is experimental in this study because it is not approved by the Food and Drug     Administration (FDA) for patients with lung cancer. Decitabine is approved by the FDA for     treating patients with a blood disease called myelodysplastic syndrome (MDS, a condition     where the bone marrow does not make blood cells normally).      THU is an investigational (experimental) drug that works by blocking an enzyme that breaks     down decitabine. This enzyme is highly expressed in solid tissues of the body, limiting the     distribution of decitabine into these tissues, including solid cancer tissues. So, THU will     increase the time cells in your body are exposed to decitabine. The idea is that THU will     also increase the time that the lung cancer cells are exposed to decitabine. THU is     experimental because it is also not approved by the FDA, although it has been extensively     used in clinical trials, including several cancer trials.   "
47478|NCT02664168|"     The aim of this study is to assess the prevention of incision healing complications in     patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared     to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a     revision TKA and THA who consent to taking part in the study, and meet the eligibility     criteria will be included onto the study. Patients will be followed up for a period of up to     3 months to determine if there are any latent incision healing complications   "
47658|NCT02661802|"     The purpose of this study was to evaluate the acute effects of oxygen supplementation during     a submaximal exercise test in patients with Eisenmenger's Syndrome.   "
47481|NCT02664129|"     The deficit of awareness of pathology (or insight) is a common symptom in patients with     schizophrenia and has a negative impact on the prognosis of the disease. Current treatments     aren't effective enough on this symptom (Pijnenbord et al., 2013).      Previous studies have shown a positive impact of videos of patients themselves on insight but     they lacked power (Davidoff et al., 1998 ; Vikram et al., 2008 ; David et al., 2012). This     technique needs more investigation. Our study aims to improve the patient's awareness of     pathology with a video of themselves recorded in the acute phase of their illness. Patients     will watch this video after clinical stabilization. This is a randomized controlled and     single blinded trial. A population of 60 patients (30 in each group) will be included. The     impact on the insight, symptomatology, treatment adherence and functional remission will be     evaluated.      The video of patient is useful for a personalized clinical follow-up. Its use for therapeutic     purposes would be innovative and could be extended to other applications in psychiatry,     especially as this tool is readily available.   "
47482|NCT02664116|"     This research will be conducted to see if the oral drug Cambia is as effective in relieving     severe migraine headaches as the injectable drug ketorolac.   "
47483|NCT02664103|"     Primary Objectives:        -  To assess the safety for each cohort of patients on a fixed-dose combination pill of          capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule          (defined as continuous daily treatment without interruption) in patients with metastatic          breast cancer.        -  To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination          pill of capecitabine and cyclophosphamide administered at different doses/regimens by          metronomic schedule in patients with metastatic breast cancer.      Secondary Objectives:        -  To assess antitumor activity of the fixed-dose combination pill of capecitabine and          cyclophosphamide administered at different doses/regimens by metronomic schedule in          patients with metastatic breast cancer given at 3 different doses and schedules (regimen          1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low          dose [OD])        -  Disease Control Rate (DCR)        -  Overall Response Rate (ORR)        -  Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors          (RECIST) criteria (version 1.1).        -  To evaluate the compliance under treatment.        -  To describe evolution of toxicities.        -  To assess safety all along patient's treatment.   "
47484|NCT02664090|"     Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in ICU. This     syndrome is associated with high morbidity and mortality. In management of ARDS patients,     lung protective ventilation and prone ventilation are key strategies which have shown     survival benefits in recent years. Prone positioning has been reported to have hemodynamic     disturbances like hypotension and arrhythmias. The literature till date is unclear with     regards to acute hemodynamic changes which can happen during initiation of prone ventilation     ,with a few studies suggesting decreasing cardiac output and a few increasing cardiac output.     In recent years, trans-esophageal Doppler (TED) has become one of important hemodynamic     assessment tool due to its minimal invasiveness, ease of use with its clinical utility     established by various studies both in operation theatres and intensive care units. In     current study, the investigators would like to evaluate acute hemodynamic effects of prone     ventilation with TED in patients of acute respiratory distress syndrome (ARDS).   "
47485|NCT02664077|"     This study is a randomized, double-blind, post-chemotherapy, adjuvant phase III clinical     trial. The primary aim of this study is to determine the value of regorafenib in improving     disease-free survival (DFS). Patients with Stage III (IIIB or IIIC) colon cancer as defined     by the 7th Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual are     randomized 1:1 to placebo or the experimental agent regorafenib following completion of at     least four months of standard adjuvant therapy (e.g., 5-fluorouracil, leucovorin, oxaliplatin     (FOLFOX) , capecitabine, oxaliplatin (CapeOx), and other).   "
47486|NCT02664064|"     The goal of this study is to evaluate an online Diabetes Prevention Program adapted for     patients with prediabetes in safety net health care settings.   "
47487|NCT02664051|"     This is a randomized, double-blind, cross-over study in healthy volunteers. In the first     part, the duodenum of the participants will be perfused with acid or saline, during which     intragastric pressure will be monitored to assess activation of the duodenogastric reflex.     After perfusion, duodenal biopsies will be collected to evaluate mucosal integrity. In the     second part, healthy volunteers are treated with the mast cell stabilizer disodium     cromoglycate or with a placebo during 14 days. Subsequently, the duodenum will be perfused     with acid and intragastric pressure and mucosal integrity will be evaluated.   "
47488|NCT02664038|"     Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent     in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive     function) reduce ability to benefit from current treatments. These cognitive impairments are     especially common in the early phase of recovery, persist over years and get worse with age.     Recent research suggests that cognitive remediation therapy (CRT) may improve attention,     memory and executive function in other disorders, and the investigators just completed pilot     study with AUD Veterans found significantly greater improvements for those receiving CRT. The     proposed study examines AUD outcomes and neurocognitive improvements when CRT is combined     with a standardized alcohol treatment. The investigators hypothesize that CRT will improve     neurocognition and AUD outcomes more than standardized alcohol treatment alone. Findings will     determine whether CRT augmentation can benefit Veterans with AUDs.   "
47489|NCT02664025|"     Teaching technical skills during medical training can lead to some issues, which can concern     ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific     because it concerns the genital area and it interferes with obstetrical management.   "
47490|NCT02664012|"     The purpose of this study is to measure plasma nicotine uptake parameters, physiological     measures, and subjective effect measures in smokers during and following a single ad libitum     use of three menthol electronic cigarettes versus combustible menthol cigarettes and nicotine     gum.   "
47491|NCT02663999|"     This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK)     study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray     using two dose levels   "
47492|NCT02663986|"     The primary aim of this project is to address the need for an effective school-based     intervention for elementary school-aged students with Organization, Time Management, and     Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that     it can be implemented in school settings. Investigators are learning to adapt an individual,     clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive     Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To     this end, investigators will be collecting data on implementation (such as feasibility and     acceptability), program development (what changes to the individual OST-C program were made     based on findings during this study) and limited outcome data (repeated measures collection     and pre- and post-treatment collection on a small sample, no control group).   "
47493|NCT02663973|"     The principal goal of this study is to describe the epidemiology of breast cancer in the     Brazilian population   "
47494|NCT02663960|"     Anticoagulation is required to prevent clotting in the extracorporeal circuit during     continuous renal replacement therapy (CRRT). Regional citrate anticoagulation has many     advantages regarding bleeding risk and filter survival. However, in clinical practice, its     use worldwide has been limited by cumbersome protocols . In order to establish a simple     scheme for universal application. In Aug 2015, the investigators have adopted a new protocol     using a fixed citrate concentration in the filter of about 4 mmol/L (called fixed group for     short) instead of conventional adjusted citrate doses according to postfilter ionized calcium     levels of less than 0.4mmol/l (adjusted group), and speculated the abilities on efficacy and     safety as well as convenience.   "
47495|NCT02663947|"     Hydrocephalus is a disturbance of cerebrospinal fluid production, flow and absorption leading     to intracranial hypertension. Assessment of the change in intracranial pressure after     ventriculoperitoneal shunt surgery is important in guiding appropriate postoperative     management. The optic nerve sheath diameter measured using ultrasonography has been verified     as a non-invasive indicator of intracranial hypertension in various clinical studies. The     investigators hypothesized that a change in optic nerve sheath diameter detected through     ultrasonography could help ascertain a reduction in intracranial pressure following     ventriculoperitoneal shunt surgery in adult patients without the risk of serious     complications.   "
47496|NCT02663934|"     Management and treatment of older persons living with HIV (PLWH) (≥ 50 years old) is becoming     increasingly more complex as a majority is greater than 50 years old. This proposal will     conduct a prospective controlled intervention trial to assess the quantitative and     qualitative effects of a monitored aerobic/resistance exercise (EXS) program compared to a     social-interaction stretching (SIS) program on brain health (neuropsychological performance     testing and neuroimaging measurements) in older PLWH. These results could influence public     health policy by encouraging PLWH to adopt a more physically active lifestyle and stimulate     the development of effective EXS programs for older PLWH.   "
47497|NCT02663921|"     The purpose of this study is to learn more about the potential effects of visible light on     the skin. More specifically, this study will examine whether an incandescent lamp (light     bulb) or LED light bulb can cause skin to become darker. Investigators will determine the     minimum threshold dose required to achieve immediate pigmentation darkening (IPD), persistent     pigmentation darkening (PPD), and delayed tanning (DT) for Fitzpatrick skin types IV - VI     utilizing two visible light sources.   "
47499|NCT02663895|"     This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis     (SSc) and at least one calcinotic lesion of the hands that is palpable on physical     examination and also measureable on hand radiographs, at one single center. Each subject will     receive treprostinil orally for 12 months, and follow-up evaluations will be performed every     3 months. Our main objective is to determine whether oral treprostinil is safe, and effective     in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of     microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial     in the treatment of calcinosis in patients with SSc.   "
47500|NCT02663882|"     The purpose of this study is to learn more about self-control and adults who smoke     cigarettes. It has been suggested that people can improve self-control by practicing tasks     that require the use of self-control (such as delaying cigarettes or sitting up as straight     as possible). The goal of this study is to learn about whether scores on self-control and     other measures will change after one week of practicing self-control tasks at home. We     believe that adults who smoke cigarettes will show better self-control after practicing tasks     for a week.   "
47501|NCT02663869|"     Clinical hypotheses:      The increasing number of people aging with HIV is a matter of fact. Differences in prevalence     of comorbidities between the general population and HIV-positive patients are mainly driven     by duration of HIV infection rather than chronological age of HIV+ patients.      People aging with HIV display heterogeneous health conditions. Host factors and duration of     HIV infection are associated with increased risk of MM, independently from chronological age     and these factors are responsible of the prevalence difference of comorbidities and MM in     comparison to the general population.      Objectives:      The study objective is to assess the prevalence of, and risk factors for, individual     co-morbidities and multi morbidity (MM) between HIV-positive patients with similar duration     of HIV infection, but 30 years difference. We compared estimates across both groups to a     matched community-based cohort sampled from the general population.   "
47586|NCT02662751|"     The main objective of this study is to compare two post-stroke/TIA (transient ischemic     attack) imaging strategies in terms of the number of clinically important (i.e. requiring     specific treatment according to current recommendations) lesions detected. The first strategy     is the current/usual strategy in each participating centre and the second strategy consists     in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose angiography and     subsequently resorting to elements of the usual strategy if required.   "
47587|NCT02662738|"     This study is to quantify the effect of a natural fruit extract added to a wheat product on     the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE     * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)   "
47502|NCT02663856|"     Understanding the complexity of aging and frailty in chronic HIV infection motivated Italian     team members to begin to build a frailty index (FI) including 37 health variables at the     Modena HIV Metabolic Clinic (MHMC). The validation of FI in HIV patients have been recently     published, and more data comparing FI in HIV infected vs un-infected people, have been     presented at international meeting and are at present submitted for publication.      The research consortium (MHMC, HCC and HHMP) of this study was motivated to begin preliminary     work in consideration of the similar multidisciplinary approach in Ageing care and capacity     to address health status in ageing HIV patients using shared definitions of co-morbidities,     multi-morbidity and measures of Physical Function and Cognition impairment, disability and     quality of life. The investigators wanted to overcome the major criticism intrinsic in the     FI, that is the needs to collects many variables not easily available in most HIV centres.     The the investigators approach is to make patient living with HIV (PLWH), be the source of     health variables taking advantage of information and communication technologies available     with smart phones and fitness tracking device, collecting physiological parameters and     patient related outcomes.   "
47503|NCT02663843|"     Tracheal intubation under general anaesthesia is the gold standard for securing the airway     and for protecting the lungs against gastric aspiration. The conventional technique involves     the use of a metal laryngoscope inserted into the mouth to create an air space, to allow     insertion of an endotracheal tube.      Alternatively, an oral airway device (called a supraglottic device (SGD)) can be used for     tracheal intubation. The SGD is first inserted. A fibrescope is inserted down the shaft of     the SGD and into the trachea. This allows an endotracheal tube (previously pre-loaded onto     the fibrescope) to be railroaded of the fibrescope and into the trachea. This technique is     called 'low skill fibreoptic intubation' as the SGD acts as a guide for the fibrescope. Our     study compares the performance of two SGD: i-gel and air-Q. The investigators will compare     intubation success rate, insertion rate, and times for SGD insertion and intubation.   "
47504|NCT02663830|"     The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in     women undergoing induction of ovulation using clomiphene citrate.   "
47505|NCT02663817|"     The hypotheses of the study are as follows:        -  Mass-based inverse optimization in radiotherapy treatment planning will result in a          reduction of normal tissue and organs at risk (OAR) doses for desired prescription          therapeutic doses to the targets.        -  Dose-mass histograms (DMHs) may be more relevant to radiotherapy treatment planning and          treatment plan assessment than the standard of care, realized through dose-volume          histograms (DVHs)   "
47516|NCT02663661|"     The type 1 Diabetes (T1D) TrialNet Pathway To Prevention (PTP) Study assesses and recruits     at-risk subjects into clinical trials aimed at preventing the development of full blown T1D.     Thousands of first and second degree relatives of persons with T1D are screened for     autoimmune abnormalities and positive subjects are followed with metabolic and autoantibody     tests. The investigators' ancillary study us designed to test whether characterization of the     insulin- glucose-glucagon (IGG) interactions in participants in the PTP study can provide new     information about the early stages of the disease. When completed, this study will improve     the understanding of the pathogenesis of the early stages of T1D and provide new quantitative     tools for prediction and evaluation of insulin-glucagon-glucose interactions relevant to     individuals at risk for developing T1D, thereby enabling future preventive intervention     trials.   "
47506|NCT02663791|"     Arterial stiffness is an important marker of cardiovascular health. Recent evidence from     cross-sectional research has suggested it is associated with alcohol consumption. Research     that employs a longitudinal perspective may be better equipped to evaluate the nature of this     relationship and in particular to determine whether alcohol consumption is linked to the     progression of arterial stiffness over time. The current study will consequently implement a     longitudinal cohort design to evaluate the association between long-term alcohol consumption     patterns and changes in arterial stiffness. Data will be drawn from the Whitehall II cohort     study of British civil servants, in which participants completed repeat pulse wave velocity     (PWV) assessments of arterial stiffness across a four-to-five year interval. Repeat     measurements of volume of alcohol intake were also recorded for participants, extending back     across more than two decades. Intake will be categorised in such a way as to distinguish     between different alcohol consumer types, including non-drinkers and former drinkers. Linear     mixed effects models will be used with adjustment for potential confounds, such as age,     diabetes, mean arterial pressure and heart rate. Results from the modelling work will     illustrate the extent and form of the association between alcohol intake and PWV. This work     will provide useful insights into the role that alcohol intake plays in the longitudinal     progression of an important cardiac marker, and it will have implications for our     understanding of alcohol's relationship to cardiovascular health in the general population.   "
47507|NCT02663778|"     This randomized clinical trial targets 248 community-dwelling older adults with impaired     mobility (i.e. walking slowly; gait speed < 1.20 m/s). The trial compares a 12 week     standard-plus program of strength, endurance, flexibility plus task specific timing and     coordination training to a standard 12 week strength, endurance and flexibility program. The     primary outcome is gait speed at 12 weeks. Secondary and tertiary outcomes represent     components of the intervention and measures of activity and participation. Delayed and     sustained effects of the intervention are examined at 24 and 36 weeks.   "
47508|NCT02663765|"     Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality     rate because adequate utilization of antenatal health care services is associated with     improved maternal and neonatal health outcomes. The trend of maternal mortality in developing     countries has been increasing and various international organizations have reported that an     important factor related to maternal and infant mortality has been linked to lack of     antenatal care. According to Federal Ministry of Health, some of the dangers of pregnancy and     childbirth can be avoided if the pregnant woman attends antenatal regularly. In order to     decrease these mortality rates, regular antenatal care has to be instituted or reinforced     which can only be achieved through identifying factors causing poor utilization of antenatal     care services   "
47509|NCT02663752|"     Several previous studies (clinical and non-clinical) hypothesize that treatment with     deferasirox causes a hematological improvement in transfused patients with low and     intermediate-1 risk myelodysplastic syndrome. The purpose of this study was to assess the     presence of genetic biomarkers predictive for hematologic response by the use of gene     expression profiling of bone marrow aspirates obtained from MDS patients with or without     hematological response.   "
47510|NCT02663739|"     The study is a post-market surveillance study required by Japanese Regulatory Authorities as     a condition of approval   "
47511|NCT02663726|"     There is evidence that yoga has beneficial effects on several aspects of physical and mental     health. However, few studies have explored the acceptability and health effects of yoga in     older adults. This preliminary study will explore the effects of a 10-week yoga intervention     on physical function and quality of life in older adults. Data collected in this study will     be used to inform the design of a subsequent adequately-powered randomised controlled trial.   "
47512|NCT02663713|"     Taken together the results from CHARISMA and PEGASUS-TIMI54, it appears that physicians may     consider extending beyond 1 year or reinitiating treatment with clopidogrel 75 mg od or     ticagrelor 60mg bid in patients with a prior MI and features of high ischemic and low     bleeding risk. Comparative clinical or pharmacodynamic studies, however, between clopidogrel     75 mg od and ticagrelor 60 mg bid in the chronic phase of stable post MI patients have not     been performed.      In a platelet substudy of PEGASUS-TIMI 54, 180 patients who had received >4 weeks of study     medication had platelet reactivity assessment. Ticagrelor 60mg bid achieved high levels of     peak and trough platelet inhibition in nearly all patients, with similar consistency of     effect compared to 90mg bid. Platelet reactivity (PRU) was significantly reduced with     ticagrelor 60mg bid compared to placebo.      In light of this, we believe that a dedicated pharmacodynamic study of ticagrelor 60 bid mg     vs clopidogrel 75 mg od in a PEGASUS-like population would be informative for the practicing     clinician, thus setting the rationale for conducting this specifically designed     investigation.      This is a prospective, randomized, single blind, single center, crossover study. Eligible     patients undergoing P2Y12 receptor antagonist therapy before screening will undergo a 14-day     minimum washout period before randomization. Following screening/washout period (visit 1),     patients will be randomized (visit 2, time 0) in 1:1 fashion to either clopidogrel 75 mg od     or ticagrelor 60 mg bid. Following 14±2 days (visit 3) patients will receive alternate     treatment for additional 14 days (visit 4). Platelet reactivity assessment will be performed     with the VerifyNow P2Y12 reaction assay at time 0, prior to first study drug dose. At visit 3     platelet function will be assessed at 2-4 hours post dose and prior to crossover. At visit 4     also platelet function will be assessed at 2-4 hours post study drug post dose. All patients     will receive concomitant aspirin (100 mg/d) and standard secondary prevention medication.      The primary endpoint is the platelet reactivity measured in P2Y12 reaction units (PRU) at the     end of the 2 study periods (pre-crossover and post-crossover).   "
47514|NCT02663687|"     This trial is looking to gain information about the safety and tolerability of an     investigational treatment (SHP623) in healthy adult volunteers. This study will also collect     pharmacokinetic data (how the body absorbs and breaks down the study drug).   "
47515|NCT02663674|"     This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals     aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility     criteria in endemic regions. This study is designed to provide data on the effectiveness of     early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also     referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in     subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by     their health care provider for acute CAP will be randomized to receive either placebo or 400     mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response     of early empiric antifungal therapy with fluconazole at Day 22 in subjects with     coccidioidomycosis pneumonia and are compliant with the study intervention.   "
47532|NCT02663453|"     The purpose of this study is to compare the effects of a multicomponent lipid emulsion     containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil     with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis,     infant growth, infant morbidity and the biochemical assessment of liver enzymes.   "
47517|NCT02663648|"     This study involves observing the level of cell cycle regulatory gene in patients with     myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential     thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal     blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA,     RNA, protein or plasma will be used in laboratory studies.      Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk     inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and     stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased     proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still     unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the     possible role in MPD and better understand the cause of MPD.   "
47518|NCT02663635|"     A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with     add-on extended finger flanges   "
47519|NCT02663622|"     This is a multicenter prospective randomized phase IIa/IIb clinical trial designed to     determine the MTD (Maximum Tolerated Dose) of CD24Fc for acute GVHD (Graft Versus Host     Disease) prophylaxis.   "
47520|NCT02663609|"     Chart review study to collect patient data from medical charts of patients who have been     treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.   "
47521|NCT02663596|"     The purpose of this investigation is to evaluate the safety of delivering continuous infusion     (CI) vancomycin in pediatric CRRT by utilizing CI via by mixing the vancomycin into the CRRT     solution(s). The secondary objectives are to describe the ability to achieve therapeutic     vancomycin concentrations by utilizing this new delivery technique.      Primary Objectives:      To determine whether delivering continuous infusion vancomycin mixed into the CRRT solution     can maintain therapeutic levels of drug in patients being treated for proven or suspected     Gram-positive bacterial infections.   "
47522|NCT02663583|"     The goal of this laboratory research study is to learn about symptoms and activity levels of     patients with OPSCC that receive IMPT or TORS.   "
47523|NCT02663570|"     The aim of our study is to investigate the effects of a treatment with melatonin on clinical,     endocrine and metabolic features in women affected by PCOS. The study group included 40     patients treatend with 2 mg of melatonin daily for six months. Menstrual pattern,     anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular     count, an oral glucose tollerance test and hormonal assays are evaluated before and after     therapy.   "
47524|NCT02663557|"     Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to     be a major modifiable risk factor for stroke.Even the casual visit hypertension has been     managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study is     to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure     variability (BPV) contribute to recurrent stroke.   "
47526|NCT02663531|"     Alzheimer´s disease (AD) in one of the most important causes of dementia and poses a     considerable challenge in health care. Today, criteria for the diagnosis and the follow up of     patients with AD mainly rely either on subjective tests or invasive methods. This limits the     general applicability of the latter test for population screening and underlines the need for     the identification of easily accessible tools for the identification of high-risk subjects.     Because of its unique optical properties, the eye offers the possibility of the non-invasive     assessment of both structural and functional alterations in neuronal tissue. As the     neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative     changes in the brain are accompanied by structural and possibly also functional changes in     the neuro-retina and the ocular vasculature. The current study seeks to test the hypothesis     that beside the known anatomical changes, also functional changes can be detected in the     retina of patients with AD. For this purpose, flicker light induced hyperemia will be     measured in the retina as a functional test to assess the coupling between neural activity     and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness     and function parameters such as ocular blood flow and retinal oxygenation will be assessed     and compared to age and sex matched controls.   "
47527|NCT02663518|"     Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory     hematologic malignancies and selected solid tumors.   "
47528|NCT02663505|"     Capacity on intensive care units is limited but inevitable for high risk surgery and/or high     risk patients i.e. patients with severe preconditions.      Contrary, if there is no capacity on an ICU elective surgery has to be postponed.      The aim of this study is to evaluate the current allocation process of ICU capacities and     analyze parameters important for ICU admission in an university hospital in Germany. In a     second phase a risk score for ICU admission shall be invented from parameters obtained during     phase one (ICU-Risk-Score). This new score will then be evaluated in a third phase of the     project.   "
47529|NCT02663492|"     To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone     marrow suppression in patients with lung cancer.   "
47530|NCT02663479|"     The purpose of this study is to evaluate the efficacy and safety of a proprietary     nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group     of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive     agents or other nutraceutical supplements.   "
47531|NCT02663466|"     Background. Limberg flap, one of the recently being popularized off-midline closure     techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus; however,     recurrences still can be seen.      Objective. The aim of this study was to assess the relationship between recurrence and     off-midline closure errors made in Limberg flap reconstructions.      Design. A multicenter, matched-case-control study was conducted in three participating     centers in Turkey.      Settings. Each hospital's database was searched separately and all patients with and without     recurrence who underwent LF surgery for primary SPS from January 2008 to July 2015 were     identified.      Patients. Sixty patients with recurrent disease (recurrent group, RG) and 120 matched cases     of recurrence-free patients for at least 5 years following surgery (non-recurrent group, NRG)     were included to the study.      Interventions Main outcome measures. According to the off-midline closure concept, LF     reconstructions were classified into incorrect closures (Type 1, 2 and 3) and correct     closures (type 4, 5 and 6). Then the two groups were analyzed.   "
47560|NCT02663089|"     Batefenterol (GSK961081) is a bifunctional bronchodilator that is being developed for the     treatment of Chronic Obstructive Pulmonary Disease (COPD). Absorption, metabolism and     excretion of batefenterol have been studied in animals, in vitro, and in previous clinical     studies; however, the elimination routes and metabolic pathways of batefenterol have not been     fully elucidated in humans. This is an open-label, single centre, non-randomised, 2-period     single-sequence crossover, mass balance study to determine total radioactivity (drug related     material) in plasma, the rate and extent of excretion of total radioactivity in urine and     faeces and the total recovery of radioactivity of [14C] GSK961081 administered as a single IV     dose (concomitant with an inhaled non-radiolabelled dose) and a single oral dose, in healthy     male subjects. A total of 6 healthy male subjects will be enrolled. The duration of each     subject in the study is up to 11 weeks, which consists of a screening visit, 2 Treatment     Periods, and a follow up visit.   "
47540|NCT02663349|"     Maintenance of employment is dependent upon being able to successfully integrate into one's     work setting. This can present a significant challenge to individuals with serious mental     illness, as they typically exhibit impairment in their ability to accurately perceive and     understand social exchanges. Presently the most established intervention is Social Cognition     and Interaction Training (SCIT), a 12-week group intervention in which participants learn     strategies to enhance emotion recognition and to assess the accuracy of their interpretation     of social interactions. To enhance transfer of training gains to functional outcomes,     participants will be paired with a social mentor to facilitate completion of homework and to     ensure that skills are practiced outside of treatment (supported SCIT). The study will     examine the impact of supported SCIT on social and work role functioning.      The specific aims are:        1. To assess the feasibility of providing supported SCIT to individuals with serious mental          illness who are engaged in compensated work activity.        2. To assess the impact of supported SCIT on social cognitive skills as well as work and          social performance.        3. To assess durability of intervention-induced change 3 months after the end of          intervention.      A randomized, active-placebo controlled, parallel groups, single blind study will be     conducted in which 60 participants between 18-60 with serious mental illness (schizophrenia,     schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported SCIT or     an active placebo condition, a computer skills course. Each intervention will consist of two     1-hour small group training sessions and 1 hour of individualized supported practice of     skills with a treatment facilitator weekly. Feasibility will be assessed with attendance at     group and individual sessions. Baseline, post-intervention, and follow-up assessments will     measure social cognitive abilities and functional outcomes . Potentially confounding     variables such as symptom severity and outside treatment hours will also be assessed. It is     hypothesized that supported SCIT will be completed by at least 75% of veterans assigned to     that condition. The intervention is predicted to improve social cognitive skills and social     and work performance. Training gains are expected to be sustained 3 months after     intervention.   "
47541|NCT02663336|"     The purpose of this study is to determine the percentage of patients with masked hypertension     in a population with chronic kidney disease. The investigators goal is to register     prospectively ambulatory blood pressure measurement results of patients of a nephrological     outpatient clinic with normal office blood pressure to finally find the percentage of masked     hypertension in this population.   "
47542|NCT02663323|"     MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open     label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting     Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery     lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe,     Brazil and South Africa. Primary outcome of study will be Proportion of population reporting     Major Adverse Cardiac Events at 6 months from the day of index Procedure.   "
47543|NCT02663310|"     The purpose of this study is to investigate the efficacy of surgical     decompression/untethering, combined with weight bearing rehabilitation, on neurological     recovery following chronic spinal cord injury.   "
47544|NCT02663297|"     The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancer. This research study combines two different ways of fighting disease:     antibodies and T cells. Antibodies are proteins that protect the body from disease caused by     bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which     stops them from growing and causing bad effects. T cells, also called T lymphocytes, are     special infection-fighting blood cells that can kill other cells, including tumor cells or     cells that are infected. Both antibodies and T cells have been used to treat patients with     cancers. They both have shown promise, but neither alone has been sufficient to cure most     patients. This study is designed to combine both T cells and antibodies to create a more     effective treatment. The treatment that is being researched is called autologous T lymphocyte     chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30)     administration.      In previous studies, it has been shown that a new gene can be put into T cells that will     increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes     make up the chemical structure carrying the patient's genetic information that may determine     human characteristics (i.e., eye color, height and sex). The new gene that is put in the T     cells in this study makes a piece of an antibody called anti-CD30. This antibody floats     around in the blood and can detect and stick to cancer cells called lymphoma cells because     they have a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been     used to treat people with lymphoma, but have not been strong enough to cure most patients.     For this study, the anti-CD30 antibody has been changed so that instead of floating free in     the blood part of it is now joined to the T cells. Only the part of the antibody that sticks     to the lymphoma cells is attached to the T cells instead of the entire antibody. When an     antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30     chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do     not last very long in the body and so their chances of fighting the cancer are unknown.      The purpose of this research study is to determine a safe dose of the ATLCAR.CD30 cells that     can be given to subjects after undergoing an autologous transplant. This is the first step in     determining whether giving ATLCAR.CD30 cells to others with lymphoma in the future will help     them. The researchers also want to find out what side effects patients will have after they     receive the ATLCAR.CD30 cells post-transplant. This study will also look at other effects of     ATLCAR.CD30 cells, including their effect on your cancer and how long they will survive in     your body.   "
47545|NCT02663284|"     A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain     assessment tool based on the analysis of the variability heart rate which evaluates the     Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.      The aim of the present study is to assess the validity of the ANI parameter in patients with     Complex Regional Pain Syndrome treated with a nerve block (reversible pain).   "
47546|NCT02663271|"     Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of     the central nervous system in adults. Despite an aggressive multimodality treatment approach     including surgery, radiation therapy and chemotherapy, overall survival remains poor.     Novocure has shown that when properly tuned, very low intensity, intermediate frequency     electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM     Therapy) is a portable battery operated device, which produces TTFields within the human body     by means of surface transducer arrays. The TTFields are applied to the patient by means of     surface transducer arrays that are electrically insulated, so that resistively coupled     electric currents are not delivered to the patient. Optune is currently FDA-approved as a     single modality treatment for recurrent GBM when both surgical and radiotherapy options have     been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM.      This research study is being performed to determine whether or not TTFields combined with     pulsed bevacizumab treatment increases overall survival in patients with     bevacizumab-refractory GBM compared to historical controls treated with continuous     bevacizumab alone or in combination with other chemotherapy.   "
48242|NCT02654171|"     VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to     evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect     of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.   "
47547|NCT02663258|"     Abbreviated Title: An explorative Phase II study of Anti-PD-1 (Pembrolizumab) in patients     with advanced melanoma (ADAPTeM)      Trial Phase: Phase II      Clinical Indication: Stage III unresectable/stage IV metastatic melanoma      Trial Type: Exploratory Phase II trial      Route of administration: Intravenous Pembrolizumab, 200mg, 3weekly      Trial Blinding: Unblinded; open label Phase II study      Treatment Groups: All participants treated with Pembrolizumab, 200mg iv, 3weekly      Number of trial subjects: 40      Estimated duration of trial: 24 months      Duration of Participation: 24 months   "
47561|NCT02663076|"     The multicenter registry will collect clinical data from 2500 patients with non valvular     atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).      The overall objective of this registry is to assess chronic kidney disease (CKD) progression     and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR     15-49 mL/min per 1.73 m2 in routine clinical practice.   "
47562|NCT02663063|"     The study aims to explore the effects of silver spike point (SSP) treatment on common     symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer     patients.   "
47549|NCT02663232|"     This is a national, multicenter, cross-sectional epidemiological study in adult Spanish     participants diagnosed with advanced or metastatic melanoma.   "
47550|NCT02663219|"     The purpose of this study is to develop and assess the efficacy of an integrated strategy     that includes feasible and scalable interventions to identify, recruit, link to care, retain     in care, attain, and maintain viral suppression among HIV-infected men who have sex with men     (MSM) in the United States (US).   "
47551|NCT02663206|"     To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in     spastic esophageal disorders.   "
47552|NCT02663193|"     The purpose of this study is to characterize the tolerability profiles of enzalutamide and     abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS)     tolerability-and quality of life (QoL) after approximately 2 months of participants starting     treatment with one of these agents for metastatic castration-resistant prostate cancer     (mCRPC).   "
47553|NCT02663180|"     Depression is a serious mental health disease. It is generally characterized by sadness, loss     of interest in activities, and decreased energy. Globally, it is estimated that almost 350     million people suffer from depression. In Saudi Arabia, literature suggested that prevalence     of depression among boy's secondary school students in Abha city was 38.2%. Another study     found that the prevalence of depression was 22.4 % as moderate, 7.3 % as severe and 3.7% as     very severe, with a clear predominance prevalence of depression in girls as in boys (1.5     times). It is important to assess depression literacy including knowledge and beliefs about     mental disorders among adolescent. A high level of mental health literacy on depression leads     to a better understanding and outcomes of depressive disorders. Schools are a typical venue     in which to embed mental health literacy because the school students are more familiar with     educational activities. Studies concluded that educational intervention about depression     literacy and destigmatization improves knowledge and may decrease stigma. Further research,     intervention and activism are needed in the field of mental health in Arab countries to     improve awareness of mental health problems.      Objectives: This study is aimed to measure the effect of educational intervention program     about depression among secondary schools in Jazan city on depression literacy and stigma     during the academic year 2015-2016.      The intervention: the intervention will held at each selected intervention school separately.     The program will be over 2 weeks intervention as the following:        -  Educational strategies: 2 Lecture about depression 30 minutes supported by group          discussion, brochures and display of posters with mental-health slogans on depression in          the schools.        -  Contact strategies: the investigators will show a video of a young male who had been          diagnosed (i.e., not an actor) with depression.      Benefits:      * The intervention group will join educational intervention program they expected to benefit     from the program through increase their depression literacy and improve depression stigma,     and control group will not join any form of intervention.      Risk: There is no expected risk for participating in the study.      Consent: Three Informed Consents forms will be signed from students, guardians and school     manager.   "
47554|NCT02663167|"     The purpose of this study is to evaluate the feasibility and effectiveness of     Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with     Obsessive-Compulsive Disorder (OCD).   "
47555|NCT02663154|"     Postoperative nausea and vomiting (PONV) is one of the most common postoperative     complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are     approximately double those of adult patients. Aromatherapy has recently been shown to reduce     PONV in adults, but the effect in paediatric patients is unknown. The goal of this study is     to determine the feasibility of a large-scale study in the paediatric population.   "
47556|NCT02663141|"     The aim of this study is to determine whether oral losartan is effective in the treatment of     diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).   "
47557|NCT02663128|"     The purpose of this study is to measure how much of a new tablet formulation of lanabecestat     gets into the blood stream and how long it takes the body to get rid of it, compared to the     current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the     body absorbs the new tablet formulation will also be evaluated. In addition any side effects     of the study drug using both the new and current tablet formulations will be evaluated. The     study will last about 22 days, with screening required within 30 days prior to the start of     the study.   "
47558|NCT02663115|"     Project aim is to quantify the influence of a severe therapy-refractory heart failure caused     by ischemic or dilative myocardiopathy on the function of the diaphragm, its molecular     biological parameters and on the M. vastus lateralis. The control group consists of patients     with coronary artery disease (CAD) and normal left ventricular ejection fraction indicated     for coronary artery bypass graft surgery (CABG) Differences in the geneses of heart failure     (ischemic vs. dilative cardiomyopathy) will be evaluated during analysis. The     ubiquitin-proteasome signaling pathway is considered as a central issue for the mechanism of     the analyses muscle catabolism.   "
47559|NCT02663102|"     The purpose of this study is collect safety information on the use of Fluarix Tetra according     to the approved PI, over a period of 6 years from children (over 3 years of age) and adults     in Korea.   "
47563|NCT02663050|"     Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment     strategies are being held. But invasive and pharmacological therapies have good outcome with     systemic side effects. Kinesio taping is being widely used in different pain conditions.     Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention method which     can be used in outpatient practice without systemic side effects.   "
47610|NCT02662439|"     The aim of this study is to investigate whether the objective measurement of fluid overload     by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated     heart failure would improve the diuretic therapy.   "
47564|NCT02663037|"     Background: The delivery of targeted, patient-centered care for a population with     heterogeneous healthcare needs while moderating costs is a key challenge in healthcare.     Segmentation of patient populations based on clinically distinguishing features and social     healthcare needs is currently a promising method for informing the organization of healthcare     supply to these needs.      Aims: In this prospective cohort study, the investigators aim to assess the Simple Segmenting     Tool (SST) as a method of patient population segmentation in terms of its inter-rater     reliability, as well as convergent and predictive validity. We will also revise the tool     based on feedback from the validity studies should the need arises.      Hypothesis: The investigators hypothesize that the SST is able to exhibit good inter-rater     reliability, convergent validity and predictive validity for adverse events.      Methodology: Non-critical patients aged 55 and above presenting to the Emergency Department     will be screened with the SST. Raters will be paired in order to assess inter-rater     reliability. To test convergent validity, the LACE, SF-12, and Clinical Frailty Scale (CFS)     will also be used. Finally, predictive validity will be assessed by evaluating adverse event     rates of patients in each SST category. Adverse events include all-cause mortality, length of     hospital stay, emergency department visit and unplanned hospital readmission.      Significance to Health Services Delivery: This study will provide evidence supporting the use     of a standardized tool for evaluating the medical and social needs of patients at various     sites of care. Following which, tailored packages of healthcare services can then be     delivered in order to meet these needs.   "
47565|NCT02663024|"     This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter     Syndrome. Participants will be randomized to one of three doses of GC1111 or comparator.   "
47566|NCT02663011|"     Purpose:      To assess age and gender effect in the language error type (semantics, syntax and     pragmatics)of developmental delay preschool aged children, a standardize tool Preschool     Language Scale Corrected edition(PLS-C), Lin was adopted for evaluation.      Methods:      This is a retrospective chart study enrolled 55 children aged 3, 4 and 5 in department of     rehabilitation in Taipei Medical University Hospital from 2011 Jan to 2014 Dec whose average     PLS-C score was at least 1.5 SD below normal. Those normal or PLS-C score was less than 1.5SD     below normal were excluded. We recorded correct percentage in pragmatics, syntax, and     semantics in different age group separately in auditory comprehension, language expression as     well as overall performance. All wrong questions answered in PLS-C were recorded. We used SAS     9.4 (Anova, t-test) to analyze the results in age differences, gender differences, and     language components differences      Results:      In overall performance, expression, and comprehension, there was no difference between boy     and girl by t-test in all ages. By one-way Anova Bonferroni t test, age 5 was better than age     4 and age 3 significantly in pragmatics, syntax and semantics (p<0.005).      We further separated into groups of 5YR boy, 5YR girl, 4YR boy, 4YR girl, and 3YR boy.      In overall performance, by Duncan's multiple analysis, only 5 YR boy had significant better     performance than 4 YR girl and 3 YR boy in pragmatics. In age 5, boys had better performance     in pragmatics than girls (p<0.05). In age 4, no differences are showed between boy and girl.      In comprehension, in age 5, boys have better performance in pragmatics than girls(p<0.05).      In expression, there was no difference between boys and girls. Pragmatics was better than     syntax (p=0.0202<o.o5) in age 5.      Conclusion:      We found age had more effect than gender in language delay children. Age 5 boys had better     performance in pragmatics conflicted with some previous studies and may need more exploration     in the future.      Key words:      Development Delay, Preschool aged children, Language Development Delay, Semantics, Syntax,     Pragmatics, Language error type   "
47567|NCT02662998|"     The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to detect     significant hearing impairment as part of a comprehensive geriatric assessment in patients     aged 70 years and older. The pass or fail screening cut-off is defined as having two or more     consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5     - 2.0 kHz.   "
47568|NCT02662985|"     This study is designed to leverage the sensitivity of ultrasonography available in clinical     practice setting to better describe the time course of response to secukinumab (150 mg and     300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to     non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global     Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR)     synovitis score (GLOESS) and changes in joint enthesitis will be assessed using the OMERACT     enthesitis score.   "
47569|NCT02662972|"     Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have     enough effect with the available pharmaceutical treatments and are offered surgery. There are     different types of procedures and most of them are complex with a risk for complications. The     researchers want to start a pilot study on 10 patients with a new surgical technique using     neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an     important role in facial pain. There have been a few trials trying to block this structure in     trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers     technique requires local anesthesia only (awake patient). The researchers believe that this     treatment can become a low threshold-treatment for patients who do not have enough effect     with pharmacological treatment and a better alternative to other complex surgical approaches.     Using this new neuronavigation system the researchers can reach this neural structure with     high precision.   "
47570|NCT02662959|"     Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable     or metastatic disease at the time of diagnosis. Systemic therapy was required for the     patients with advanced stage. Platinum combined with fluoropyrimidines always were considered     as first line treatment. After failure of initial therapy, single agent of taxanes was used     as second line treatment. However, there is no relative standard chemotherapeutic regimen in     the third therapy except oral anti-angiogenesis drug-Apatinib. So this study was designed to     explore the role of single agent with irinotecan as third line treatment in patients with     metastatic gastric cancer in China.   "
47571|NCT02662946|"     A randomized controlled multicenter trial on the usefulness of intraoperative angiography     with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic     rectal resection or left colectomy.   "
47583|NCT02662790|"     The current study aims to investigate the effects of dexamethasone exerted on fetal and     uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for     preterm birth after 24 hours of its administration.   "
47584|NCT02662777|"     This international, prospective and multicenter registry was designed to collect clinical     evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after     esophageal resection or iatrogenic or spontaneous esophageal perforation.   "
47585|NCT02662764|"     Patients who meet all inclusion and exclusion criteria at screening and following surgery     will receive the Zalviso System™ and evaluate its usability and functionality for up to 72     hours.   "
48243|NCT02654158|"     Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of     Fuganlin Oral Liquid in children with acute upper respiratory infection   "
47572|NCT02662933|"     AML is a disease of older adults, with a median age at diagnosis of 67 years . An estimated     13,410 new cases of AML will be diagnosed in 2007. Survival for AML is age-dependent, with     significantly lower survival rates reported for older adults. SEER statistics from 1996-2003     show a 5 year relative survival rate of 34.4% for adults younger than 65 and 4.3% for those     ≥65 years of age 1. Clinical trials have demonstrated worse survival outcomes in older adults     with AML using age cutoffs of 55, 60 and 65 years. Older adults have also experienced     increased toxicity to standard therapies in clinical trials. Chronologic age cutoffs have     therefore been used in research and clinical practice due to concerns regarding toxicity     associated with treatment. The reasons for the increased toxicity and decreased survival in     older adults with AML is incompletely understood and likely multifactorial including both     tumor specific and host specific factors. Improving understanding of which measurable     clinical characteristics predict vulnerability to toxicity will help refine the research and     clinical approach to older adults with AML.   "
47573|NCT02662920|"     Prevalence and prognostic significance of polypharmacy has not been evaluated in adults     undergoing treatment for AML. Investigating the significance of polypharmacy in this     population may help improve patient assessment and provide an opportunity to design simple     interventions to minimize unnecessary morbidity associated with treatment.   "
47574|NCT02662907|"     The goal of this clinical research study is to learn if exercising the muscles that help you     cough and swallow, called expiratory muscle strength training (EMST), can help reduce the     risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients     who have had radiation for head and neck cancer.   "
47575|NCT02662894|"     Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin     versus their isolated components in treatment of hypertension and dyslipidemia.   "
47576|NCT02662881|"     This study will evaluate the performance of biologically assisted core decompression with the     PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The study     will explore the potential impact of patient demographics and baseline characteristics on     post-operative outcomes.   "
47577|NCT02662868|"     The purpose of this study is to describe demographics and socioeconomics characteristics     associated to the diagnosis of metastatic breast cancer in Brazil.   "
47578|NCT02662855|"     The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a     broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the     most difficult aspect for clinical management of EVD due to its high fatality rate.   "
47579|NCT02662842|"     Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to     improve quality of life and glucose control in many patients with diabetes opting for this     treatment modality. Despite significant innovation and advancement in pump technology,     insulin infusion sets have been an area where innovation has been significantly lacking with     no clinical studies performed prior to product launches.      BD has developed a subcutaneous infusion set with FlowSmart™ Technology designed to address     patient comfort, insulin delivery and flow interruptions. According to preliminary animal and     clinical studies, this technology results in lower infusion pressure indicating more     consistent insulin delivery.      The FlowSmart infusion set has been previously tested in prototype form with healthy     non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who     self-inserted the FlowSmart infusion set in a clinical research setting.      The purpose of this study is to determine if insulin pump users prefer using the BD FlowSmart     infusion set compared to their current set with respect to insertion pain and wear comfort.   "
47580|NCT02662829|"     Lesotho, a small, landlocked country completely surrounded by South Africa, is among the     world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB)     and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV     coinfected. Data from similar settings suggest that TB incidence in children is approximately     50% of adult TB incidence. The Lesotho National TB Program has adopted World Health     Organization's (WHO) isoniazid preventive therapy (IPT) recommendations for child contacts;     however, as in other countries in the region, implementation of IPT in children is limited,     no clear strategies guide child contact tracing and screening, and no clear methods ensure     provision of IPT in children. Thus, it is important to evaluate novel methods to prevent TB     in child contacts of adult TB cases.      The purpose of the PREVENT Study is to identify an effective and acceptable intervention that     addresses programmatic, structural and psychosocial barriers to contact tracing, screening,     and IPT for child contacts of TB patients, with the ultimate goal of improving health     outcomes among children in Lesotho. The study is a two-arm cluster randomized trial,     randomized at the TB clinic level, which includes ten TB clinics in Berea district. Clinics     are randomized to deliver the community-based intervention (CBI) or standard of care (SOC),     with stratification by facility type. The experimental intervention will be delivered to all     child contacts of adult TB patients in TB clinics randomly assigned to CBI. In TB clinics     assigned to SOC, usual care procedures for contact tracing and IPT will be delivered.   "
47581|NCT02662816|"     Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates     also in the detoxification of electrophiles molecules of which paracetamol. It is synthesized     in the liver during the postprandial phase, which establishes a stock that is mobilized for     the other tissues (muscle)during the postabsorptive period. It is of common knowledge that     the decrease in glutathione concentrations associated with ageing could be involved in the     development of the degenerative pathologies linked to the old age. These changes could be     reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous     synthesis of GSH. The development of nutritional strategies aiming at an improvement of the     status glutathione requires the determination of its concentration within tissues, where it     is active. The quantification of tissue concentrations of glutathione by biochemical     techniques requires tissue biopsies. Such a method can be performed for the muscle, but liver     biopsy is not feasible outside of a surgery. It is necessary to set up a non-invasive method     to quantify muscle and liver glutathione.   "
47582|NCT02662803|"     This study investigate the effect of high-intense aerobe exercise training (HIT) on clinical     and physiological parameters (anxiety, somatisation, cortisol, alpha amylase, mismatch     negativity, loudness dependence auditory evoked potentials) in patients with generalized     anxiety disorder (GAD). Half of patients will receive HIT, while the other half will receive     aerobe exercise of low intensity.   "
47588|NCT02662725|"     This is a non-controlled, open label, Phase II Study of ipilimumab combined with a     Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of     Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3     days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10     mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity     or withdrawal of consent or disease progression. The primary objective is the overall     survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute     lymphocyte count (ALC) as a predictive biomarker.   "
47589|NCT02662712|"     The purpose of this study is to evaluate pharmacokinetics and safety data including serious     and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms     (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).   "
47590|NCT02662699|"     Anemia is a common pathology in geriatrics. According to the World Health Organization it     affects 23.9% of subjects over 60 years in the world, and 8% of patients over 60 years in     Europe. A prevalence that increases with the age and twice in individuals over 85 years.   "
47591|NCT02662686|"     The number of copies of mitochondrial genes (mtDNA or MitoScore) is related to the energy     supply of the embryo, which can affect its ability to implant in the maternal uterus.      The objective of this study is to analyse the potential of MitoScore before embryo transfer     as a marker to identify and select the embryo with greater capacity of implantation. First of     all, chromosomally normal embryos will be selected and mtDNA copies will be quantified.     Finally, embryos with less copies of mtDNA will be considered for embryo transfer.   "
47592|NCT02662673|"     Focal treatment of localized prostate cancer aims to destroy the cancerous foci without     damaging surrounding tissues to avoid the side effects of radical treatments. This is why     focal treatment is positioned as an alternative to radical surgery as well as an alternative     to active surveillance.      This study is a feasibility study. It aims at treating the index tumor (the most aggressive     one) which determines the vital prognosis of patient, while preserving the maximum     surrounding prostatic tissue to preserve quality of life. The expected result is the total     destruction of aggressive tumor areas by focal or multifocal treatment strategy using the     Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by     the negative biopsy rate between 6 and 12 months post-treatment.   "
47593|NCT02662660|"     A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between     2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv     exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites     infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic     Scale and morphine rescue needs were determined 24 hours after surgery.   "
47594|NCT02662647|"     Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the     expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory     molecules and adhesion molecules. The leukemias cells treated by decitabine will become more     sensitive to the following adoptive T cell therapy.We proposed a hypothesis that     decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in     eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.   "
47595|NCT02662634|"     Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in     patients with resectable non-small cell lung cancer.   "
47597|NCT02662608|"     The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an     attempt to control tumors and prolong survival. The therapy involves participant being given     the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This     is considered an investigational treatment.   "
47598|NCT02662595|"     The question that this project seeks to answer, is whether mobile phones can be used to     increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention     will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating     evidence that could help policy makers making informed decisions about implementing mHealth     interventions at a national level.      The intervention takes the form of a randomized controlled trial in which text messages (SMS)     as well as voice calls are scheduled and delivered to mo thers to remind and encourage them     to have their children timely vaccinated against measles. In addition, the messages will     include relevant information about opening hours and availability of the measles vaccine at     the mothers' local health facilities thus improving coordination. The trial will include     three different randomization groups with approx. 350 participants in each group. The first     group will receive SMS messages, the second group will receive a voice call in addition to     the SMS messages, and the third group is a control group that does not receive any     intervention.      Study participants will be enrolled following birth at one of three health centers in     different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be     given, at 9 months of age, mothers will receive the intervention message depending on their     assigned randomization group. When the measles vaccine is administered, the child will be     registered as having received the measles vaccination.      A follow-up phone interview will be conducted at 12 months of age for all children     participating regardless of randomization group and whether or not they received the measles     vaccine. All participating children, who at that time still have not received the measles     vaccine, will be offered the vaccine at the expense of the project.   "
47653|NCT02661867|"     Objective of this longitudinal observational cohort study was to analyze incidence of pelvic     floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary incontinence     (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two groups of     singleton primiparae after vaginal delivery (VD) and cesarean section (CS).   "
47599|NCT02662582|"     The purpose of this study is to assess the effect of CK-2127107 relative to placebo on cycle     ergometer exercise tolerance, assessed as change from period baseline in constant work rate     (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with     integrated electrocardiogram (ECG). The time to intolerance is assessed by a stopwatch and     verified from electronic recordings of the cycle ergometer.      This study will also assess cardiopulmonary and neuromuscular effects of CK-2127107 relative     to placebo; the effect of CK-2127107 on resting spirometry relative to placebo; the safety     and tolerability of CK-2127107 as well as the pharmacokinetics of CK-2127107.   "
47600|NCT02662569|"     The primary hypothesis is that both dosing regimens of SC evolocumab (AMG 145) in combination     with statin therapy will be well tolerated and will result in greater reduction of LDL-C in     diabetic subjects with hyperlipidemia or mixed dyslipidemia.   "
47601|NCT02662556|"     This is a multicenter, open-label study in patients 40 years and older who are undergoing a     surgical procedure.      Patients may receive one dose of ST 30 mcg as needed for pain management, but no more     frequently than every 60 minutes, for up to 12 hours.   "
47603|NCT02662530|"     This study investigates the use of a kinematic measurement device to quantify the abnormal     head movements and postures in patients with cervical dystonia (CD) in order to individualize     and optimize botulinum toxin type A (BoNT-A) injection therapy. A single sensor captures five     degrees of freedom of the neck and head that distinguish which muscle(s) contribute to CD and     the amount of BoNT-A to inject into these muscle(s). The efficacy, relief and improvements in     social, occupation and function by injections will be investigated. The efficacy of BoNT-A     therapy using either BoNT-A injection parameters from clinical-based assessments and     kinematically-based assessments will be investigated in CD patients. Individuals clinically     diagnosed with CD will be randomized for two treatment conditions: A) injection parameters     from a kinematic assessment only, or B) injection parameters from a clinical assessment only.   "
47604|NCT02662517|"     Human breast milk contains growth factors including neurotrophins and cells with     neuroprotective potential. Concerning growth factors milk of preterms differs significantly     from term milk. The aim of this study is to give a profile of human milk concerning     non-nutritive factors depending on gestational age and lactation phase.   "
47605|NCT02662504|"     Malignant pleural mesothelioma (MPM) is an aggressive tumour with poor prognosis (median     survival <13 months), and high resistance to chemotherapy. Extended pleurectomy/decortication     (eP/D) is a debulking surgery of MPM but cannot be considered as a curative treatment.     Therefore it has been suggested that eP/D may be of interest if combined with intra-operative     treatment and adjuvant therapies.      Photodynamic Therapy (PDT) is an innovative treatment based on the rationale that tumour     cells, if previously treated with photosensitizing drugs (Photofrin), will die when exposed     to light at a particular wavelength. Interestingly PDT might also stimulate anti-tumour     immune response through the release of tumour antigens and induced inflammation.      PDT was tested in phase I-II trials for MPM in combination with EPP or eP/D, and     chemotherapy. US studies from J Friedberg et al found very promising survival results in MPM     when combining eP/D, but not EPP, intra-operative PDT and chemotherapy     (cisplatin-pemetrexed), with a median overall survival of 31.7 months.      However, the definitive value of intra-pleural PDT combined to eP/D in the treatment of MPM     still need to be validated. The same multimodal treatment has been established in Lille, the     French national expert centre for MPM, with the help of our american colleagues. Therefore,     this phase II trial proposes to patients to benefit from the combination of eP/D,     intra-operative PDT then chemotherapy by cisplatin-pemetrexed and prophylactic radiotherapy.      Primary endpoint is the feasibility for the patients to have the full multimodal treatment of     MPM including intrapleural PDT without unacceptable or unexpected grade III-IV toxicities.     Secondary endpoints are PFS, OS, ORR, and quality of life. If the feasibility of such     treatment would be confirmed in France, a multicentric, randomized trial comparing this     experimental treatment vs control arm (same multimodal treatment without PDT) is planned.   "
47606|NCT02662491|"     The trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU),     calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D     deficiency will lead to a clinical benefit. The proposed study will also determine the     threshold of vitamin D and calcium intake or levels considered optimal for UAE citizen's     health   "
47607|NCT02662478|"     Despite laparoscopic surgical treatment has not been recommended in patients with gastric     gastrointestinal stromal tumors (GIST) larger than 5 centimeter, but it continues to evolve     rapidly to overcome the boundaries. Therefore the authors generated a morpho-anatomical     classification system (MACS) adapted for primary gastric GISTs, by which they could plan to     tailor the laparoscopic gastric resection appropriately. The aims of the study was to     demonstrate the feasibility of laparoscopic surgery for primary gastric GISTs larger than 5     cm, to find out the accuracy and practicality of the MACS for the development a preoperative     strategy and the extent to which this strategy overlaps with the reality.   "
47608|NCT02662465|"     Before the start of the selected chemotherapy patients will be treated preventively for oral     mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five     days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW     and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right     buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who     develop oral mucositis even after the prevention, will be divided into three groups for laser     sessions with the purpose of treatment of oral mucositis. The group assignment obeyed     severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera     used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients     with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia     of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode     AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency     of 8 J / cm².   "
47609|NCT02662452|"     The purpose of this First-in-Human study is to evaluate the safety and tolerability after     single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part     1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to     healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).      Furthermore, during the course of the study after single and multiple oral dose     administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics)     will be characterized.      The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222     will be explored as well.   "
47611|NCT02662426|"     Name of study:      Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study about     Lingdancao Granules in the Treatment of Seasonal Influenza      Objective:      Preliminary evaluation on the efficacy and safety of Lingdancao granules in the treatment of     seasonal influenza      Design:      Multicenter, randomized, double-blind, double parallel analogy, positive drug and placebo     controlled trial      Case number:      This test is expected to be included in 318 cases of 14-65 (≥14 or ≤65) ages of subjects.     Qualified participants are randomly divided into experimental drug group (Lingdancao granules     group), positive control group (oseltamivir phosphate group) and placebo group, 106 cases in     each.   "
47612|NCT02662413|"     To determine the measurement profiles of the asthma control test (ACT) in an adolescent     population with persistent asthma.   "
47672|NCT02661620|"     A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a     post-market, retrospective-prospective, multi-center, single arm, consecutive series study     design to provide data on the post market performance and safety of the study device. The     study will collect retrospective data from medical records review and prospective data from     observations data at 5 and 10 postoperatively clinical visits. There will also be a 7 year     telephone follow up contact to assess for device status and adverse events.   "
47673|NCT02661607|"     A prospective study to compare the use of point of care echocardiography versus routine chest     radiography for the assessment of central venous catheter placement.   "
47613|NCT02662400|"     India is the Diabetes Capital of the World with 41 million Indians having diabetes i.e.     every fifth diabetic in the world is an Indian. Type 2 Diabetes Mellitus (T2DM) constitutes     the major chunk of diabetes and has insulin resistance as the hallmark feature in the     pathogenesis. However, with the progression of the disease the insulin resistance becomes     stable whereas β - cell function shows a gradual decline due to its ongoing apoptosis. This     ultimately leads to inability of the β - cells to cope up with the increased demand of     insulin caused due to insulin resistance and manifests as hyperglycemia. As β - cell failure     is progressive and inexorable, as demonstrated in United Kingdom Prospective Diabetes Study,     most of the patients with T2DM would eventually require insulin and it would be difficult to     achieve to attain a strict glycemic control . It is well known that diabetes related     complications which account for morbidity and mortality in this disease can be prevented or     delayed by strict glycemic control. However, even with intensive insulin therapy it has been     shown that glycemic control can never be perfect with patients exhibiting hyperglycemia or     hypoglycemia during 24 hour glucose profile. Also insulin therapy is not physiological as     there is no hepatic first - pass metabolism of insulin which is required for halting the     hepatic glucose output, which is responsible for fasting hyperglycemia. This led the     researchers to evolve various strategies of β - cell replacement therapy e.g. pancreatic     transplantation and islet cell transplantation. Initially the results of islet cell     transplantation were dismal but after the induction of glucocorticoid free immunosuppressive     therapy and the use of adequate number of islet cells from multiple donors, the results of     islet cell transplantation have been better. However, islet cell transplantation has its own     limitations viz insufficient supply, being technically demanding and requirement of lifelong     immunosuppressive therapy in the recipient.   "
47614|NCT02662387|"     Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common     diagnoses in children admitted to pediatric intensive care unit.      Objectives: The primary outcome of the study is to compare the respiratory parameters between     patients on HFNC and HFNC with ENDs.      Methods: This is a prospective randomized controlled trial. All children admitted to Loma     Linda University Children's Hospital due to acute respiratory failure secondary to     bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory     parameters will be collected as part of the study. The investigators anticipate that use of     END will have a positive impact on the respiratory status of children with acute respiratory     failure. Appropriate statistical analysis of the data will occur after the data has been     de-identified.   "
47615|NCT02662374|"     Oral mucositis is one of the most common debilitating forms of mucositis that arise from high     dose chemotherapy and radiotherapy. It is reported that almost 75% patients undergoing     hematopoietic cell transplantation (HCT) develop oral mucositis at different levels of     severity. The objective of this prospective study was to assess the efficacy of the addition     of supersaturated calcium phosphate oral spray and the addition of an extra soft tooth brush     to the basic OH in addition to the currently existing oral hygiene protocol regimen (0.2%     Chlorhexidine Gluconate + 3% Sodium Bicarbonate+ Nystatin 100000 U/ml) in reducing the     severity of oral mucositis among patients receiving chemotherapy for HCT.      60 patients receiving chemotherapy for HCT were randomly allocated to four groups of 15     patients each The oral mucositis was recorded according to WHO criteria and the progression     of the oral mucositis was monitored from the day of admission (day        -  1) to the day of discharge (day 28). The absolute neutrophil count, platelet counts and          salivary flow rate of all patients was recorded.   "
47616|NCT02662361|"     To investigate the patient-related risk factors for peri-implant disease in partially     edentulous patients rehabilitated with implants supported crown or bridge so as to provide     evidence for clinical prevention and control.   "
47617|NCT02662348|"     This phase I trial is to investigate the safety and the possible side effects of bi-specific     antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients     with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been     coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor     receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells     from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.   "
47618|NCT02662335|"     This randomized clinical trial studies computerized cognitive retraining in improving     cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as     thinking and memory issues, are common among breast cancer survivors. The severity of these     cognitive deficits is associated with a significant negative impact on daily function and     quality of life. A computerized cognitive retraining method may help researchers find ways to     improve cognitive function and quality of life in breast cancer survivors.   "
47619|NCT02662322|"     The purpose of this study is to compare three communications during peripheral intravenous     catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with     negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).   "
47621|NCT02662296|"     This phase II trial studies how well ibrutinib or idelalisib works in treating patients with     chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is     persistent or has returned (relapsed) after donor stem cell transplant. Ibrutinib and     idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth.   "
47622|NCT02662283|"     This prospective, randomized, controlled, multi-center clinical trial will evaluate the     effect and security of reh-acteoside therapy for patients of IgA nephropathy.   "
47654|NCT02661854|"     The purpose of the study is to evaluate the more efficient dose for the treatment of     rhinitis/rhinoconjunctivitis against mite allergy   "
47623|NCT02662270|"     Fibromyalgia is a relatively young condition recently recognized by the WHO as a separated     clinical entity. Part of the medical comunity thinks of it as a mixed condition between     depresion and rheumatic pain, however, functional data provided by sophisticated imaging     techniques points at a diminished brain activity in several brain regions. The present study     aims to characterize those findings by means of QEEG in order to establish the     electroencephalographic characteristics of fibromyalgia patients.   "
47624|NCT02662257|"     Surgery is one of the major treatment methods for patients with malignant tumor. And, alone     with ageing process, more and more elderly patients undergo surgery for malignant tumor.     Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous     anesthetics, may influence the outcome of elderly patients undergoing cancer surgery.     Delirium is a commonly occurred early postoperative cognitive complication in the elderly,     and its occurrence is associated with the worsening outcomes. Choice anesthetics may     influence the occurrence of postoperative delirium. However, evidence in this aspect is     conflicting.   "
47674|NCT02661594|"     Randomised, single-dose, crossover, placebo-controlled study to see if intravenous     amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy     adult volunteers.   "
47625|NCT02662244|"     Basal cell carcinoma (BCC) is the most common skin cancer worldwide. Although this tumor is     rarely life threatening, it is locally destructive and can cause significant cosmetic and     functional problems. Standard therapeutic modalities for BCC often result in disfigurement     from surgical treatments and recurrences with topical therapies. Thus, there is a need for     alternative non-surgical options that are effective, efficient, and have a low risk of side     effects. This has led to the emergence of laser investigations for the treatment of BCC due     to the ease of treatment, lack of significant downtime, decreased risk of complications, and     absence of a surgical scar. The primary objective of this study is to evaluate the safety and     efficacy of laser treatment of subjects with BCC on the trunk and extremities. Subjects will     receive one treatment with the laser to the BCC. Standard excision will be performed between     30 and 90 days after laser treatment to evaluate resolution of the BCC. A visit for suture     removal will be performed as appropriate for the site of the surgery. Standardized     photographs and measurements will be taken at the baseline visit, immediately after laser     treatment and on the day of excision.   "
47626|NCT02662231|"     Surgical site infection (SSI) is the most common complication following major     gastrointestinal surgery, affecting between 25-40% of patients. The rate of SSI doubles from     low-income to high-income settings, persisting after risk adjustment. Investigating the     diagnosis and treatment of SSIs remains a largely unaddressed global health priority. The     impact of antibiotic resistant organisms and the effectiveness of antibiotic prophylaxis are     unknown. This study aims to determine SSI rates following gastrointestinal surgery across     worldwide hospital settings.   "
47627|NCT02662218|"     This prospective, multicenter, single-arm observational study aims to document the clinical     performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the     intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds     of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of     infection or at high risk of infection and also high to very high exudate levels will be     observed over a period of 14 days.   "
47628|NCT02662205|"     Clients of the student counseling center at Oklahoma State University who are interested in     participating in the study will be randomly assigned to a traditional process group, a yoga     class, and a yoga therapy group. Outcome of the three conditions will be compared.   "
47629|NCT02662192|"     This study examines the effect of an exercise and health education/auditory rehabilitation     and socialization intervention on functional fitness, hearing handicap and psychosocial     distress measures in older adults with hearing loss.   "
47630|NCT02662179|"     Identifying the frail elderly patients or those at risk of becoming frail has become a     cornerstone of modern geriatric medicine. Many instruments have been developed to identify     fragility at the individual level. The 'Fragile' phenotype defined by Fried is based on 5     criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight     loss. The patient is fragile if it meets at least three out of five criteria. It is     'pre-fragile' if it meets one or two criteria.      In onco-geriatrics, the International onco-geriatrics society recommends the implementation     of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8     are then referred to the geriatric team to benefit from a comprehensive geriatric assessment.     This evaluation is interpreted by the geriatrician, who proposes an action plan to overcome     the various problems of the elderly patient. The evaluation can also help the oncologist in     the choice of treatment for the patient: palliative care, standard treatment or adapted     treatment (No-go, Go-go or slow-go).      The investigators would like to assess if fragility as defined by the Fried criteria is     predictive of a functional, physical or cognitive decline, or a loss of quality of life in     patients treated for a solid malignant tumor.      Furthermore, they will assess if the frailness categorization has an impact on the oncologic     treatment decision. Does the oncologist switches the patient's oncologic treatment after     being informed of the frailness status ?   "
47631|NCT02662166|"     Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to     be a major health problem. This prospective non-randomized study will enroll 150 patients     undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and     therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will     have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT)     and biomarker collection. After pathology review of the histological specimens, patients will     be treated according to standard clinical practice. The second MRI examination will be     performed before therapeutic intervention, if TUR-BT alone is not sufficient enough.     Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while     intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated     using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant     chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk     patients will be followed by annual with MRI examination.   "
47632|NCT02662153|"     Retrospective study to assess incidence and predictors of opioid abuse, addiction, overdose &     death among patients prescribed ER/LA opioid products   "
47655|NCT02661841|"     We aim to determine the effectiveness of lung impedance guided preemptive therapy (LI-Guided)     of chronic heart failure patients with preserved ejection fraction (LVEF ≥ 45%) who are being     treated in our hospital's outpatient clinic.   "
47633|NCT02662140|"     The primary purpose of this study is to develop a mobile health (mHealth) application that     will both advance theory in and clinical practice of homework (HW) implementation. The mobile     health application will enhance the existing evidence informed curriculum of a Multiple     Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for families with     children who have disruptive behavior disorders. This mobile application consists of two     primary components that will support engagement and integration of the model's core concepts     in family life. The first component focuses on delivering homework via a highly engaging,     multiplayer, interactive, cooperative, and skill-building game platform aimed at improving     the Design and Do process of homework.The second component focuses on targeting factors     putatively related to poor HW implementation within the Do process.   "
47896|NCT02658695|"     The aim of this work is to assess the effect of air bubbles localization inside the uterus on     embryo transfer outcome in ICSI cycles.      Is there a relationship between embryo transfer outcome and the distance between fundal     endometrial surface and air bubbles assessed by trans-abdominal ultrasound?   "
47634|NCT02662127|"     Venous disease effects 25% of the population and most healthy people experience venous     symptoms after standing for too long. The prime function of leg veins is drainage. Failure     leads to a condition called chronic venous insufficiency (CVI) with leg pain, heaviness,     swelling, varicose veins, ankle skin changes, eczema and occasionally venous ulcers. The aim     of the study is to identify blood components (biomarkers) that occur during the damaging     phase of standing versus the healing phases of lying recovery and with medical compression     stockings. This will be achieved by taking a blood sample from the ankle region at 3 separate     visits (days) to the vascular laboratory at Ealing Hospital. The first visit will be after     supervised standing for 1 hour. The second after supervised lying and the third standing     whilst wearing a medical compression stocking. Healthy volunteers will be compared to     patients with advanced CVI.      The potential importance to patients and the public is threefold. Firstly, biomarker profiles     will be obtained in each of the 3 states to increase understanding in the cellular mechanisms     of damage and recovery. In this way bad and good biomarkers can be identified. Secondly,     drug treatments may develop from this research to adjust biomarkers towards a favourable     profile. Thirdly, the success of treating CVI with surgery, venous intervention or     compression can be monitored. Whilst it is known that relief of gravitational stress is the     treatment for all forms of CVI, the mechanisms of repair and its discrimination from damage     have yet to be identified.   "
47635|NCT02662114|"     This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness     of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or     type 2 diabetes mellitus.      EU-TREAT (EUropean TREsiba AudiT)   "
47636|NCT02662101|"     Chronic non-healing wounds considerably impact quality of life in affected patients and are a     substantial burden on the Canadian health care system. Microbes colonizing a chronic wound     play an important role in impeding effective healing. Chronic wounds are colonized by     polymicrobial communities and no single organism can be seen as causal. Only a small fraction     of wound bacteria are cultured by diagnostic tests and studies have shown little agreement     between culture and molecular based approaches, therefore an effective diagnostic for wound     microbes is required. It is know that the composition of the microbial community associated     with a wound changes as it heals although the causal relationship is somewhat unclear.     Although not very effective in treating chronic non-healing wounds, antibiotics are often     administered, contributing to concerns of antibiotic resistance. The wound dressings produced     by Exciton Technologies Inc. (ETI) effectively aid in the healing process in chronic wounds     through unknown mechanisms. ETI's wound dressings contain a combination of silver salts with     three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in     reducing biofilm formation in vitro. However, it is not known how these silver salts impact     microbial ecology of the wound and the role this plays in wound healing. The objectives of     this research are to develop a new diagnostic tool based on molecular characterization of     wound sites so as to predict how to best treat wounds and to identify new microbes to be     targeted by ETI's technology. This project will utilize molecular microbial ecology for the     assessment and evaluation of topical silver interventions, gaining insight into the     management of chronic infection. Substantiating the microbiota-modifying effectiveness of     silver wound dressings towards increasing clinician and patient understanding to improving     clinical outcomes.   "
47637|NCT02662088|"     The purpose of this study is to collect a multi-institutional database including all relevant     data regarding the surgical and clinical features of patients underwent to laparoscopic     lavage for complicated colic diverticulitis. The main objectives are:        -  To determine the surgical and clinical outcomes, in the short and long term.        -  To compare results according to the different type of techniques, device used and manner          of execution of the different surgical steps.        -  To relate results of different surgeries with baseline characteristics of patients and          stage of disease.   "
47638|NCT02662075|"     The primary purpose of this study is to evaluate the acute effects of electronic cigarette     (e-cigarette) smoking on measurable biomarkers of platelet function, vascular endothelial     function and inflammation in healthy active smokers. 10 healthy subjects, smokers, with no     other medical conditions will be included in this study and measurements will be obtained at     baseline and after smoking an e-cigarette. The study will contribute to the understanding of     the effects of e-cigarettes on cardiovascular physiology, specifically establishing if the     use of e-cigarettes increases platelet aggregation and platelet activation when compared to     baseline in healthy active smokers, if the use of e-cigarettes decreases brachial artery     flow-mediated dilation compared to baseline in healthy active smokers, and to determine the     association between biomarkers of inflammation, platelet function, and vascular endothelial     function before and after use of e-cigarettes.   "
47639|NCT02662062|"     This study will enrol patients with maximally resected (via transurethral resection (TURBT)     non-metastatic muscle invasive bladder cancer, who either wish to attempt bladder     preservation therapy or are ineligible for cystectomy. Patients must have adequate organ     function and performance status to receive cisplatin based chemoradiotherapy, and no     contraindications to the use of pembrolizumab. The study will enrol 30 patients to be treated     with pembrolizumab and radiotherapy.      All patients will be planned to be treated with 64Gy of radiation therapy in 32 fractions     over 6 weeks and 2 days. All patients will receive cisplatin 35mg/m2 IV concurrently weekly     with radiation therapy for 6 doses total. Pembrolizumab will commence concurrently with     radiation and be given 200mg IV every 21 days, continuing until the 12 week cystoscopy and     assessment.      Surveillance cystoscopy will be performed 12 weeks after the commencement of     chemoradiotherapy, and assess the rate of complete response to therapy. A safety follow up     visit will occur 4 and 12 weeks post cystoscopy. From week 31 survival follow up will     commence with clinical assessment, cystoscopy and CT staging performed at intervals until 5     years.      The objective of the study is to assess the safety and feasibility of combining pembrolizumab     with chemoradiotherapy. The primary endpoint assessed will be safety, as defined by a     satisfactorily low rate of unacceptable toxicity (G3-4 adverse events or failure of     completion of planned chemotherapy and radiotherapy according to defined parameters). The     secondary endpoint will be efficacy, as assessed by complete response rate of the primary     tumour at first post chemoradiotherapy cystoscopic assessment. Exploratory analysis will     include assessment of tumour histopathological, molecular, genetic and immunological     parameters.      It is expected that it will take two years to accrue the required 30 patients.   "
47656|NCT02661828|"     The purpose of this study is to compare two ways to stop taking an antidepressant medication     and determine whether a faster or slower taper is better tolerated.   "
47640|NCT02662036|"     This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine     (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in     terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12,     24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of     stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead     to greater patient satisfaction.   "
47675|NCT02661581|"     PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and     sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved     from previous short-term diabetes education program. Our goal is to provide a new generation     of education and support that can be ongoing, patient-driven, and flexible to the dynamic and     evolving conditions of patients' real-word environment and life circumstances.   "
47641|NCT02662023|"     Single-injection transversus abdominis plane (TAP) blocks have been used to treat     postoperative pain, and are become very popular within the United States because of their     high analgesic potency and relative ease of placement. Unfortunately, the longest local     anesthetic available lasts only 8-12 hours. Continuous TAP blocks—also termed perineural     infusion—involve bathing the multiple nerves of the abdominal wall in local anesthetic using     a percutaneously-inserted perineural catheter inserted just anterior (ventral) and cephalad     to the anterior superior iliac spine. For most catheter locations, an infusion is preferred     to a single-injection nerve block because the duration of analgesia may be extended to better     match the duration of surgical pain. But, unlike brachial plexus, femoral, and sciatic nerve     perineural infusion, a continuous basal infusion of local anesthetic does not provide     adequate analgesia for TAP catheters. This may be due to the fact that the TAP is a     relatively tight space, so it might require a bolus of fluid to adequately spread the     perineural local anesthetic to the multiple required nerves (as evidence of this,     single-injection TAP blocks are very effective, although with a limited duration). The result     is that while single-injection TAP blocks are widely used, TAP catheters have not been     adopted. This scenario leaves surgical pain untreated following the resolution of the     single-injection TAP block. The recent development of an infusion pump that can automatically     deliver repeated bolus doses may allow the spread of local anesthetic to the multiple sensory     nerves necessary to provide adequate analgesia, with a duration that better matches     postoperative requirements. The investigators therefore propose a randomized, double-masked,     controlled trial to determine if delivering local anesthetic as a repeated bolus dose results     in improved local anesthetic spread/effects compared with a continuous basal infusion for TAP     catheters.   "
47642|NCT02662010|"     The overall purpose of this COMIRB application is to perform a cross-sectional pilot study to     aid in the design of a prospective epidemiologic study for an NIH grant application. The long     term goal of this research is to determine if AGEs are predictors of glycemic control and the     development of diabetic retinopathy in patients with T2DM. Understanding these relationships     could lead to a prospective prediction of the onset/worsening of diabetic retinopathy in T2DM     patients and in pre-diabetic individuals.   "
47643|NCT02661997|"     The primary aim of this study is to examine the beneficial effects of two novel treatments     for Gulf War Veteran's Illness (Tai Chi and Wellness intervention) and to establish the     efficacy of these mind-body approaches to symptom reduction.   "
47644|NCT02661984|"     FeNO measurements provide the physician with means of evaluating an asthma patient's response     to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory     assessments in asthma. Interpretation of FeNO profiles is based on the nitric oxide plateau.     To achieve plateau, the duration of exhalation must be sufficient (at least 4 seconds for     children <12 years and > 6 seconds for children > 12 years (ATS/ERS, 2005).      Measurement of FeNO using the 6-sec mode may provide a viable alternative in children as     young as age 4 years who may have difficulty maintaining exhalation for a full 10 seconds.   "
47645|NCT02661971|"     Previous studies provide a strong theoretical rationale for the conduct of a randomized study     evaluating the efficacy and safety of ramucirumab in combination with FLOT in the     perioperative treatment of resectable adenocarcinoma of the stomach or GEJ.   "
47646|NCT02661958|"     The purpose of this study is to evaluate the superiority in efficacy and assess safety and     tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active     components or the vehicle for the treatment of acne.   "
47647|NCT02661945|"     Near-focus with narrow-band imaging is a novel technique to improve the quality of images of     the irregular mucosal structures and microvessels of gastric neoplasms. The investigators     compare this technique with indio carmin spray, commonly used tool to determine tumor margin.     The subject are patients who underwent endoscopic submucosal dissection for gastric     neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo     carmin groups. First, marking is performed at the tumor margins determined by each modality.     The distance from the marking dots to the tumor margin is measured histopathologically in the     resected specimens. Finally, the investigators will compare the accuracy between two groups     based on the distance from marking dots to tumor margin measured by histopathologic     examination.   "
47648|NCT02661932|"     The purpose of this study is to evaluate efficiency and safety of controlled ovarian     stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility     preservation in breast cancer patients.   "
47649|NCT02661919|"     Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of     death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory     factors are involved. Several ways of preventing SUDEP have been identified. These include     seizure control, stress reduction, physical activity, family's ability to perform CPR, and     night supervision.      A mattress alarm system that monitors nocturnal seizures can alert family members of night     time seizure activity. Thus, a family member could provide aid and therefore potentially     avoid SUDEP. The Emfit monitor is intended to perform these tasks.      Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit bed     sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the device     has a high predictive value for detection of generalized convulsions and that it can notify     caregivers in the early stages of convulsive activity.      This study will further investigate the upgraded (connected to a cloud server via an     integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit     mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification     system.   "
47650|NCT02661906|"     The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has     effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.   "
47651|NCT02661893|"     The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on     the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male     and female participants.   "
47652|NCT02661880|"     Current practice in larger palliative care centers offer many supportive service modalities,     which are often unavailable in the rural setting. Music Therapy by experienced registered     Music Therapists is an example of such a modality. The current evidence continues to grow,     identifying Music Therapy's benefits to help with symptom relief as well as to improve     Quality of Life in many aspects of medicine, but especially in the context of palliative     care. This proposal outlines an initiative to provide music-based interventions in a rural     community palliative care unit where there is limited availability to a registered Music     Therapist.   "
47676|NCT02661568|"     This study will utilize a retrospective cohort design. Using the Clinical Practice Research     Datalink (CPRD) linked with Hospital Episode Statistics (HES) datasets, all patients with a     record of VTE diagnosis between 1 April, 2008 and 31 March, 2013 will be identified and     followed from the occurrence of VTE (index date) to the first of 24 months after the index     date, end of the study period, leaving the database, or death.   "
47659|NCT02661789|"     The project aimed at identifying neuropsychobiological signatures of pharmacological     sex-steroid hormone manipulations in healthy women as a risk model for depression.      The study is a double-blind, randomized, placebo-controlled study. Investigators included 63     healthy female volunteers with regular menstrual cycles between 23 and 35 days. Participants     were randomized to active Gonadotrophin-Releasing-Hormone agonist (GnRHa) (goserelin 3.6 mg     implant) or placebo (saline injection) intervention, which was initiated in the mid     follicular phase (i.e. cycle day 22.6 ±2.5). Sixty women completed follow-up and entered the     analyses, except for a few drop outs on some domains. The following domains were addressed at     baseline and at follow-up (16±3 days post intervention), (which corresponded to the early     ovarian suppression phase of the biphasic hormone response to GnRHa): 1) serotonin     transporter binding as imaged by 11CDASB Positron Emission Tomography (PET), 2) functional     Magnetic Resonance Imaging (fMRI) emotional processing, 3) fMRI reward processing, 3) rating     state fMRI (rsfMRI), 4) structural MRI, 5) Neuropsychology, 6) Psychophysiology, 7)     Hypothalamus-Pituitary-Adrenal cortex (HPA)-axis dynamics, 8) Peripheral markers of     immunoactive cell responses, 9) Epigenetic factors.      Psychometrics in terms of self reported mental distress and interview based ratings were     monitored across the intervention period to monitor potential symptoms of mental distress and     psychopathology. Also ovarian hormone responses, peripheral blood markers, and side effects     scores were collected across the intervention period.   "
47660|NCT02661776|"     Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical     procedures significantly reduces the immune function in proportion to the degree of tissue     injury. In addition, the use of opioids as analgesics during the perioperative period depress     cellular immunity, in particular the activity of the natural killer (NK) cells. This     perioperative immunosuppression may cause deleterious consequences on postoperative outcome     in cancer patients. The aim of this study is to confirm the presence or extent of the change     of NK cell activity between before and after head and neck surgery. Additionally,     investigators will identify the clinical or genetic factors related to the change of NK cell     activity.   "
47661|NCT02661763|"     This study will determine the prevalence of rheumatic heart disease (RHD) in Lusaka, Zambia     through school-based screening methodology using ultraportable echocardiography and a     recently validated, abridged screening protocol based on World Heart Federation criteria.     Children that screen positive for RHD at schools will undergo confirmatory evaluation at     University Teaching Hospital (UTH), Lusaka's main referral hospital.   "
47662|NCT02661750|"     The purpose of this study is to document the safety and effectiveness of high doses of     liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a     poorly cleaned colon.   "
47663|NCT02661737|"     To evaluate long-term safety of YVOIRE volumes by incidence of adverse events including     injection site local reactions and biodegradability.   "
47664|NCT02661724|"     Persons with burn-related pain remain under treated and do not have access to comprehensive     burn pain management. We seek to extend evidence-based cognitive behavioral pain management     strategies to a group of burn survivors that are currently under treated for for burn pain     with a specific goal of reducing pain related interference in life activities.      Investigators will conduct a randomized controlled trial to test the central hypothesis that     a computer-based cognitive-behavioral program (Take Charge of Burn Pain) will improve pain     management, psychological health, and improve participation in burn survivors. Specific aims     include: 1) to determine the efficacy of a web-based self-management intervention in reducing     pain and pain-related interference and increasing pain management self-efficacy; and 2) to     determine whether Take Charge of Burn Pain improves psychological health and participation in     life activities in persons with burn injury pain. Emerging research suggests that web-based     pain management interventions may be a feasible and effective alternative to clinic-based     interventions for patients with mobility and geographic restrictions, such as those treated     at tertiary burn centers.   "
47665|NCT02661711|"     The purpose of this study is to assess the safety and efficacy of intravitreal injections of     Aflibercept (Eylea) in treating Cystoid Macula Oedema (CMO) in patients with underlying     Retinitis Pigmentosa (RP).   "
47666|NCT02661698|"     This study will evaluate the absorption of two different dietary supplements containing the     omega 3 fatty acids eicosapentaenoic acid and docosahexaenoic acid over 24 hours via venous     blood plasma following a single dose taken at bed time. In addition, the circadian rhythm of     fatty acid metabolism will also be assessed following the placebo intervention.   "
47667|NCT02661685|"     The purpose of this study is to determine the safety of adoptive transferring autologous     IKDC-like cells   "
47668|NCT02661672|"     Objective: The primary objective of this multicenter prospective registry is to provide     additional safety, technical outcomes and clinical outcomes data for minimally invasive     endoscopic surgery (MIES) with Apollo for the evacuation of supratentorial brain hemorrhage     in adult patients who do not qualify for the concurrent INVEST randomized controlled trial at     active INVEST centers.   "
47669|NCT02661659|"     A phase Ib study investigating the safety, the immunogenicity and the optimal administration     frequency of the S-588210 5-peptide vaccine in MPM patients without progression after     pemetrexed-based chemotherapy will be conducted. Additionally, to identify more accurate     predictive biomarkers of response to S-588210, T-cell-receptor-sequencing (TCR) pre- and     post-vaccination will be performed in blood samples of patients treated with the vaccine.     Immunohistochemical analysis of the vaccine oncoantigens will also be correlated with     induction of antigen-specific T-cell responses. Finally, to explore the infiltration of     tumors with T-cells and the potential presence of an immunosuppressive tumor     microenvironment, immunohistochemistry for immune checkpoints (including PDL1/PD1, CTLA4) and     immune suppressive cell subsets (T-regs, macrophages) will be performed.   "
47670|NCT02661646|"     Assessment of QOL and symptoms changes in primary or secondary, unilateral or bilateral lower     extremity patients using an advanced pneumatic compression system.   "
47671|NCT02661633|"     This study is designed to collect data which will be used to correlate changes in EEG to mild     TBI in sports concussion.   "
48000|NCT02657330|"     This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects     with previously treated pancreatic ductal adenocarcinoma and will identify the maximum     tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK)     profile and preliminary efficacy of SBP-101.   "
47677|NCT02661555|"     The purpose of the project is to investigate how aerobic exercise affects brain volume,     specific brain regions, neurotrophins and cognition in patients with multiple sclerosis.      The study will be a single blinded randomized controlled trial with a 6 months intervention.      It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of     hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in     people with multiple sclerosis.   "
47678|NCT02661542|"     A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors and     Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the MTD. Phase     2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer. Cohort 2     will include subjects with another tumor type enrolled in the Phase 1 dose-escalation phase     who have demonstrated Clinical Benefit by Week 16.   "
47679|NCT02661529|"     The study aims to answer whether the use of a mixture of blood and saline alone (limited air)     provides the same degree of right-heart contrast enhancement as compared to the standard     agitated saline (with air), during two types of echocardiograms.   "
47680|NCT02661516|"     The purpose of the study is to estimate the impact of bleeding events in patients in the UK     with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).   "
47681|NCT02661503|"     Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of     BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to     PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy     objective).      If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate     reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment     measured by treatment related morbidity (TRMorbidity objective).   "
47682|NCT02661490|"     The purpose of this study is to further develop a formulation and dose regimen of the     norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe     in an elderly population aged 60 years and above.   "
47683|NCT02661477|"     The study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to     eradicate rhinovirus in patients with primary hypogammaglobulinemia. Patients with     hypogammaglobulinemia have persistent rhinovirus infections. Rhinovirus may worsen pulmonary     complications. Pegylated interferon alpha with ribavirin appear to effectively clear     persistent rhinovirus infections in hypogammaglobulinemia patients.      Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection     will be randomly assigned in a double-blind fashion to receive either        -  Group 1: subcutaneous pIFNα2a        -  Group 2: subcutaneous placebo Subjects will have scheduled study visits at 1-week and at          2-month after entry to study. In addition, possible bacterial infections will be treated          with antibiotics. Each patient will be followed with weekly nasal surveillance samples          for 2 months and a symptom diary. Blood draws take place at study entry, 1-week and          2-month time-points.   "
47684|NCT02661464|"     The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and     MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical     studies.   "
47685|NCT02661451|"     The objective of this study is to determine the safety and efficacy of transcatheter aortic     valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as     compared with OHFT.   "
47686|NCT02661438|"     The rationale of this study is to conduct a summative (i.e., validation) usability test of     Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.   "
47687|NCT02661425|"     This is a retrospective study designed to gather outcomes data from existing medical charts     from patients who have taken EnteraGam for management of their IBS-D for at least eight     weeks. Data from two study periods will be collected: (1) the time during which the Standard     of Care (SOC) therapy (i.e., prescribed or over-the-counter as well as FDA-approved or     non-approved agents) that is used immediately prior to prescribing EnteraGam; and (2) the     time during which EnteraGam is used as therapy.   "
47719|NCT02661009|"     In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung     cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth     Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical     performance of the EGFR quantitative kits.        1. methodology validation: To certify the equivalence between the EGFR quantitative kit and          the common used detection methods.        2. analysis of the relationship between the type and proportion of EGFR sensitive mutation          and EGFR-TKI benefit.   "
48047|NCT02656719|"     Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy     and bronchoscopy guided percutaneous tracheostomy.   "
47688|NCT02661412|"     Since its introduction in the late 1990s, immediate implant loading concepts (IL) have become     a frequent alternative for delayed implant procedures. IL concepts reduce chair time, the     number of surgical interventions and pain, and offer instant comfort to the patient. Its     reduced treatment time results in obvious socioeconomic advantages. Although there is at     present abundant evidence that supports IL, evaluation of long-term biological and mechanical     stability outcomes of large patient populations could allow quality improvement and more     accurate patient selection. The Departments of Oral and Maxillofacial Surgery and the     Department of Dentistry of the General Hospital Saint-John Bruges act as one of the pioneers     of IL in Belgium, routinely performing the concept since 2001.      The investigators aim to evaluate the biological and mechanical short- and long-term outcome     of IL in partially or completely edentulous patients. Moreover, the investigators aim to     detect potential influencing risk factors predicting undesirable prosthetic outcome.   "
47689|NCT02661399|"     The investigators are doing a research study that will teach us about the tingly pain that     people develop when they get chemotherapy.   "
47699|NCT02661269|"     Can videomicroscopy of the sublingual microcirculation detect the increase in edema before     peripheral edema will appear? By measuring the decrease in vesseldensity after strong     positive fluid balances within septic patients versus euvolemic post-cardiac surgery     patients. Measuring reactance and resistance (BIVA method) to determine volume status.      Primary outcome:      - Total vessel density (TVD)      Secondary outcome:        -  Fluid balance        -  BIVA measurements (reactance & resistance)   "
47690|NCT02661386|"     1. An intact pharyngoesophageal reflex is essential to protect the upper airway from          aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is          essential at protecting the airway in all patients.        2. In patients, while under general anesthesia, it is postulated that an identifiable upper          esophageal sphincter and esophageal peristalsis are not present.        3. With the cessation of general anesthetics, accompanied by the reversal of nerve block,          normal pharyngoesophageal peristaltic activity correlates with awakening the patient          from anesthesia. This would be identified by the performance of esophageal manometry.        4. A return of normal verbally stimulated pharyngoesophageal swallowing sequence accurately          identifies a safe time to remove endotracheal tubes and/or reverse anesthesia. This          verbally stimulated swallowing sequence correlated precisely with the return of          objective pharyngoesophageal function.   "
47691|NCT02661373|"     Malaria is an infectious disease caused by a parasite that is passed to humans when an     infected mosquito bites a person. About 3.4 billion people live in areas of the world where     malaria is regularly found. In many countries, malaria is one of the leading causes of     illness and death. Despite this, there are a limited number of drugs, called antimalarials,     that can be used to treat malaria and increasing reports of resistance to existing     antimalarials..      The purpose of this research study is to test a new experimental antimalarial drug called     SJ733 to first assess its safety, tolerability and blood levels in healthy adult volunteers.      PRIMARY OBJECTIVES:        -  To assess the preliminary safety and tolerability of escalating doses of antimalarial          SJ733 in healthy human volunteers.        -  To investigate the pharmacokinetic (PK) profile of escalating doses of antimalarial          SJ733 and its metabolite in healthy human volunteers.        -  To identify a dose of SJ733 that can be tested in a separate Phase 1b human malaria          challenge study.        -  To assess the preliminary safety and tolerability of SJ733 in healthy adult volunteers          after multiple oral dosing.        -  To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing          of SJ733 in healthy adult volunteers.      SECONDARY OBJECTIVE:        -  To assess the impact of food intake on the pharmacokinetic profile of antimalarial          SJ733.   "
47692|NCT02661360|"     The purpose of this randomized, within-subject, cross-over study is to examine if swaddling     affects bottle feeding performance in infants born preterm. Results from research will have     implication on neurobehavioral and physiologic outcomes as important indicators for the     possible effect of swaddling during bottle feeding.   "
47693|NCT02661347|"     The purpose of this study is to test the efficacy of transcranial direct current stimulation     (tDCS) for the treatment of auditory hallucinations in patients currently on risperidone     treatment who are experiencing recent onset psychosis.   "
47694|NCT02661334|"     The purpose of this study is to compare the physical fitness performance—as measured by the     Air Force Physical Fitness Test (PFT)—of subjects that, in conjunction with exercise, will     take creatine supplementation over a four week period versus those that do not.   "
47695|NCT02661321|"     This was an observational pilot study to examine the usefulness of an electronic sensor that     monitors short-acting beta-agonist inhaled medication use. The goals of this study were to:     1) test the feasibility of using the inhaler sensor to measure worsening symptoms and     exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine     whether environmental factors can be linked to mild exacerbations measured by the inhaler     sensor.   "
47696|NCT02661308|"     The main purpose of this interdisciplinary proposal is to conduct two randomized controlled     trial (RCT) of the efficacy of self-administered systematic light exposure (Bright White     Light (BWL)), an innovative, low cost, and low burden intervention to treat cancer-related     fatigue. Another common and often overlapping treatment side-effect is cognitive impairment.     A secondary outcome of the proposed RCT is, thus, cognitive functioning. Finally, possible     underlying chronobiological (circadian activity rhythms, sleep), biological (pro inflammatory     markers), and neurophysiological (brain morphology) mechanisms of BWL will be explored.   "
47697|NCT02661295|"     The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis     is 10-100 times higher than the normal population. This is due in part to high levels of     inflammation and vascular calcification found in these patients. Phosphate binders,     particularly non-calcium based phosphate binders, may decrease cardiovascular risk by     decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based     phosphate binder with approximately 210 mg of ferric iron has recently been approved for     patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid     levels is unknown but investigators hypothesize that ferric citrate has the potential to     improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous     iron requirements and by improving lipid metabolism.   "
47720|NCT02660996|"     The objective of this observational study is to assess the effectiveness of the Advocate     Lutheran General Survivorship Center's Programs by measuring the following outcomes of     interest on participating patients:        1. Quality of life        2. Distress level        3. Satisfaction with the Survivorship Program      General Hypothesis: Patients who participate in at least four classes in a two month period     will have higher scores on the post-class satisfaction, quality of life, and distress surveys     compared to their pre-class surveys.   "
47698|NCT02661282|"     The goal of Phase I of this clinical research study is to find the highest tolerable dose of     cytomegalovirus cytotoxic T lymphocytes (CMV CTLs) that can be given in combination with     temozolomide to patients with glioblastoma.      The goal of Phase II of this study is to learn if CMV CTLs combined with temozolomide can     help to control glioblastoma. The safety of this combination will also be studied.      This is an investigational study. CMV CTLs are not FDA approved or commercially available.     They are currently being used for research purposes only. Temozolomide is FDA approved and     commercially available for the treatment of some brain tumors, including glioblastoma. The     use of this combination to treat glioblastoma is investigational. The study doctor can     explain how the study drug/cells are designed to work.      Up to 54 participants will be enrolled in this study. All will take part at MD Anderson.   "
47710|NCT02661126|"     The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of     MK-3682B [MK-3682/grazoprevir (MK-5172)/ruzasvir (MK-8408) fixed dose combination (FDC)] in     participants with moderate (Part 1) and severe (Part 2) renal insufficiency (RI) to healthy     participants.   "
47700|NCT02661256|"     Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a     common practice in many neonatal intensive care units (NICU) all over the country. However     the safety of such practice has never been established. The Investigators hypothesize that     mechanoreceptors, which should perceive sensory input from the liquid bolus, may be altered     by the reception of pressurized airflow provided by the NCPAP, hence increase risk of     aspiration. In this study, changes in the pharyngeal phase of swallowing were identified     using video fluoroscopic swallow studies (VFSS) for infants while on NCPAP as compared to off     NCPAP.   "
47701|NCT02661243|"     Until now it has not been investigated whether placement of implants in SS patients is less     successful than compared to non-SS patients. The risk factors and the efficacy of dental     implants in dry mouth patients are not known because of the lack of scientific evidence. The     aim of this study is to investigate changes in marginal peri-implant bone loss and the     clinical performance of dental implants in SS patients compared to implants in healthy     patients.   "
47702|NCT02661230|"     This project proposes the development and design of a motor intervention using a cognitive     video game and describes the feasibility, safety and acceptability of virtual augmented video     gaming device named Virtual Reality on the Intensive Care Unit (VRICU). The project in two     phases is performed in healthy participants (Phase 1) and heart patients after elective heart     surgery on the Intensive Care Unit (Phase 2).      Furthermore, brain function will be measured during exer-gaming with the VRICU device with     non-invasive instruments (fNIRS/EEG) in both the healthy participants and the heart patients.      The VRICU device is a patient friendly construction to allow a patient exergaming in bed. The     project is a cooperation between scientist at the USZ (physiotherapist / anaesthsiologists /     engineers), human movement scientist at the ETHZ and (poly- / electro-) mechanics at the Paul     Scherrer Institut.   "
47703|NCT02661217|"     To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with     LCZ696 in HFrEF patients following stabilization after an ADHF episode.   "
47704|NCT02661204|"     The purpose of this study is to evaluate the diagnostic performance of a new ABUS system     among 4 different population:      Population A: women undergoing screening for familial or genetic predisposition for breast     cancer.      Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to     breast MRI in the pre-operative assessment of breast cancer extent.      Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS     will be evaluate as a problem-solving tool.      Population D: women undergoing breast MRI for the assessment of breast implants integrity.     ABUS performance will be compared to breast MRI.   "
47705|NCT02661191|"     The study aim is in two phases. First phase: to evaluate the influence of vitamin D     deficiency on asthma severity, degree of airway obstruction and frequency of asthma     exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH     vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease     exacerbations.   "
47706|NCT02661178|"     This study will investigate the safety, tolerability, and pharmacokinetics of single     ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also     conduct an exploratory investigation of the relative bioavailability of emodepside     administered as tablets and determine the effect of food on the pharmacokinetics.   "
47707|NCT02661165|"     This exploratory study is researching how the spirituality of a group of British patients     with type 2 diabetes (T2D), impacts their approach to the self-management of their condition.      Bio-statistical markers will be taken from consenting participants' Clinic database records.     Qualitative interviews will be conducted with participants, and the results analysed and     interpreted, alongside their bio-statistical markers.      Results will be presented in healthcare peer reviewed journals and conferences, to inform     clinicians how patients' self-management of their T2D is influenced by their spirituality.   "
47708|NCT02661152|"     Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase     radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).      In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been     possible to discriminate more hypoxic tumours from less hypoxic tumours.      A hypoxia gene profile has shown to discriminate between responders and non-responders to     nimorazole.      In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/-     nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in     selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.   "
47721|NCT02660983|"     The primary objectives are to confirm that donepezil hydrochloride has superior efficacy in     improving cognitive function, as measured by Alzheimer's Disease Assessment Scale-Cognitive     subscale (ADAS-cog), and to demonstrate that donepezil hydrochloride has superior efficacy in     improving global function, as measured by Clinician's Interview-Based Impression of     Change-plus Caregiver Input (CIBIC-plus), compared with placebo in patients with dementia     associated with cerebrovascular disease (VaD)   "
47709|NCT02661139|"     The number of patients requiring major ablative surgery in the oral cavity, including     partial/radical mandibular or maxillary resection, due to a head and neck carcinoma,     osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been     accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a     challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL).     Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery     Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital     Saint-John Bruges led to the development of the Oncology-bridge (O-bridge) protocol, which     offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a     strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at     a considerably reduced cost.      The investigators aim to develop a prospective database in which patient demographics,     surgical, dental, prosthetic and QOL parameters collected during consecutive visits within     the framework of routine practice, are being registered for each oncological patient eligible     for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity     reconstruction This could provide the investigators with more information about potential     patient, surgical and prosthetic factors influencing short- and long-term biological and     mechanical stability, as well as patient QOL. Moreover, registration of those results could     function as a measurement of quality of care, and could be used for sample size calculation     for future large prospective trials.   "
47711|NCT02661113|"     Phase II:      Primary Objectives:      -To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of     concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant     temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM) as     measured by overall survival.      Secondary Objectives:        -  To determine the efficacy of this treatment as measured by radiographic response (RR),          progression-free survival (PFS) and time to progression (TTP).        -  To characterize the safety profile of dasatinib (Sprycel) in combination with RT and          concomitant TMZ in patients with newly-diagnosed GBM.        -  To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant          TMZ in patients with GBM after RT.      Exploratory Objectives:      -To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src, EphA2,     c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and temozolomide.   "
47712|NCT02661100|"     This study will look at the safety of the combination of three drugs (CDX-1401, Poly-ICL, and     Pembrolizumab) and its effect on decreasing tumors. Pembrolizumab is an experimental cancer     drug. CDX-1401 is a tumor specific antigen and Poly-ICL is a Toll-like receptor agonist tumor     specific antigens which when combined with Pembrolizumab may increase the tumor response to     this drug.   "
47713|NCT02661087|"     Since the development in the last few years of the bipolar energy in the surgery by     hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by     use of either monopolar or bipolar current.      It seems that the use of the bipolar energy decreases the rate of adhesions but prospective     data on the adhesion rate and fertility after the use of bipolar energy during the surgery     are poor, and there is currently no recommendation as to the choice of technique to use. The     main purpose of this study is to compare the rate of uterine adhesions six weeks after the     surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar     energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.   "
47714|NCT02661074|"     Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are     recognized as zoonotic agents, and have a high impact on human health.      Infestation results from the ingestion of living larvae from contaminated fishes. It can be     asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms.     Allergic manifestations are frequently encountered in gastric forms, but isolated allergic     symptoms can occur after ingestion of Anisakidae antigens in raw or cooked fish. Cutaneous     contact or Anisakis allergen inhalation have also been reported to induce     allergy/anaphylactic reactions or sensitization in the occupational setting in Spain, Italy,     Sicilia or South Africa. But no data is available in France.      In this context, the investigators propose to determine and compare the frequency and     characteristics of fish allergy in fish workers (fishermen and fish-processing factory     workers) and a control population of workers without occupational exposure to fish, in     Boulogne-sur-Mer, which is an important fishing port in France, and the first European center     for fish processing.   "
47715|NCT02661061|"     Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for     depression relapse prevention in persons at high risk. The main purpose of the pilot study is     to assess trial processes to help inform a future definitive trial.   "
47716|NCT02661048|"     The objective of this clinical investigation is to evaluate the safety and efficacy of the     CyberHeart System in patients with refractory ventricular tachycardia (VT).      The ablation will be performed with the CyberHeart System and will target the anatomical site     of the clinically presenting VT, using standard radiosurgery techniques.      Cardiac radiosurgery is a minimally-non invasive, painless, procedure. Tissue ablation can be     accomplished precisely.   "
47717|NCT02661035|"     This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body     irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell     infusion. The primary objective is to evaluate rates of acute graft-versus-host disease     (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and     mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with     hematologic malignancies.   "
47718|NCT02661022|"     A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In     Relapsed and Refractory Multiple Myeloma   "
47735|NCT02660801|"     The objective of the present study is to compare the neuromechanical responses to spinal     manipulation and spinal mobilization in participants with and without chronic nonspecific     back pain.   "
47722|NCT02660970|"     Functional gastrointestinal disorders are common disorders that are characterized by     persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the     GI tract and are not caused by structural or biochemical abnormalities. As a result, medical     tests- such as blood tests and endoscopic exams- have essentially normal/negative     (non-disease) results. More than 20 functional GI disorders have been identified. They can     affect any part of the GI tract. One of the most common functional disorders is nausea and     dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating).     Any chronic illness, including functional nausea, will affect a person's health-related     quality of life (general well-being, ability to carry out everyday activities), additional     psychosocial disturbances and amplify the experienced illness.      The majority of children suffering from functional nausea in Europe are treated with     Iberogast®. a herbal mixture, whose effect was demonstrated in several studies. Since     Iberogast® is not available in the United States of America, children there receive an     acupressure therapy. The American gastroenterologists refer hereby to several studies, which     have shown, that the positive effect of such therapies in patients with chemotherapy-induced     nausea is even greater than a therapy with ondansetron. Since acupressure is able to reduce     somatic nausea, it is also believed to decrease functional nausea, but it has never been     investigated. Therefore, there are no data. That's why Investigators want to compare the     efficacy of these two therapies, that is, Iberogast® and acupressure   "
47723|NCT02660957|"     The purpose of this study is to test the effectiveness of using a brief, self-determination     intervention on smoking cessation (immediate or progressive) for people attending AEDs.   "
47724|NCT02660944|"     This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the     cutaneous manifestations in subjects with systemic lupus erythematosus.   "
47725|NCT02660931|"     This proposal will incorporate statistical models developed by the investigators to predict     risk for acute kidney injury into our electronic medical record system, enabling an alert to     notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in     the intervention group, for whom the notification will be implemented, or in the control     group, who will receive usual care (no notification). The investigators believe the     notification will increase appropriate screening for acute kidney injury and reduce the     severity of acute kidney injury in the intervention group.   "
47726|NCT02660918|"     To determine whether paracervical injection of long acting local anesthesia decreases     postoperative pain following endometrial ablation under general anesthesia.   "
47727|NCT02660905|"     This is an prospective open label pilot study conducted over 32 weeks.      A total of 25 eligible participants who are infected with HCV and HIV will be recruited from     2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill     University Health Centre)      This study is looking into the effectiveness of a combination of     Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF     STR) for HIV treatment and Harvoni for HCV treatment .      This study will assess the effect that the study drug has on the metabolism of sugar, the     changes in fat in the bloodstream and other metabolic changes. Metabolism is the process your     body uses to get or make energy from the food you eat.      This study may provide information on the impact of liver fibrosis (scarring of liver     tissues) on metabolic changes before, during and after HCV antiviral therapy.      Drug-drug interactions (DDI) DDI between E/C/F/TAF and LPV-SOF have been well evaluated and     no clinically significant interactions have been identified.      A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be     particularly beneficial because of its:        1. favorable side effect profile        2. once daily STR formulation        3. known DDI profile with LPV-SOF        4. neutral effect on liver fibrosis        5. improved kidney and bone safety profile with the use of TAF      Conduct of this study is justified as it:        1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and          HCV using well tolerated medications with an excellent safety profile and known DDI          profile.        2. Provides additional safety data for TAF in the HIV-HCV co-infected population.        3. Quantifies adherence and identifies obstacles to full adherence in this population.          There is a paucity of data related to DAA adherence in licensing studies.        4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF          DAA therapy in HIV-HCV co-infected populations.        5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance          in HIV-HCV co-infection        6. As a pilot study, the information gathered will inform the feasibility of future          clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.   "
47728|NCT02660892|"     Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made     in the body and must be consumed from food. Amino acids are the building blocks of protein in     your body, and need to be eaten in required amounts to maintain health and growth. Deficiency     in threonine can affect small intestine growth due to its structural importance in the     intestinal protein mucin. While threonine is found in many foods, deficiency can occur in     developing countries where nutrition is primarily plant based, and low in available protein.      Therefore, the purpose of this study is to determine the requirement of the indispensable     amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the     availability of threonine from three test proteins (soy, green pea, casein).   "
47729|NCT02660879|"     The investigators looked at the effect that video instruction located at www.useinhalers.com     would have on improving inhaler technique at a hospital in Guayaquil, Ecuador. The     investigators compared this video instruction to written Spanish inhaler education. The     investigators video taped participants before and after the intervention, and graded their     technique on a pre-defined rubric.   "
47730|NCT02660866|"     This is a Phase 4, randomized clinical trial to evaluate whether addition of Vorapaxar 2.08     mg daily vs. placebo daily on background antiplatelet therapy, prescribed for 6 months to     patients with established peripheral artery disease (PAD) and Intermittent Claudication (IC)     treated with standard medical therapy (SMT) would lead to an improvement in the peak walking     time (PWT).   "
47731|NCT02660853|"     The purpose of this study is to investigate exacerbations in severe asthma with regard to     symptoms, lung function, aetiology and biomarkers.   "
47732|NCT02660840|"     To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5     mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg     flupentixol, administered as single doses   "
47733|NCT02660827|"     This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric     subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to     demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe     as part of the overall system.   "
47734|NCT02660814|"     The objective in this case-control intervention study, therefore, was to explore the effect     of nonsurgical periodontal therapy on the GCF levels of chemerin and IL-6 in patients with     chronic periodontitis in order to determine the usefulness of chemerin as a diagnostic and     prognostic biomarker of periodontal disease.   "
47736|NCT02660788|"     A randomized, double-blinded study conducted in British Columbia, Canada, where there is a     publicly funded, organized screening program and screening mammography is recommended at     24-month intervals. Eligible women aged 51-73 years old and overdue for their screening     mammogram by 6-24 months are identified in the database of the Screening Mammography Program     of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the     overdue women in their practices. The overdue women are randomized and mailed either the     signed reminder letter and the standard reminder postcard, or the standard reminder postcard     alone. The primary endpoint is the proportion of overdue women attending a screening     mammogram appointment 6 months after the mailing.   "
47748|NCT02660632|"     Pulmonary complications are among the most important postoperative complications after     midline incisions, for which different analgesic modalities have been tried.      Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery     owing to the proved superior analgesia, reduction of opioid related side effects as nausea,     vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for     postoperative mobility However, it is not without complications.      Rectus sheath block provides several advantages over epidural anesthesia. It lessens the     potential risks associated with neuraxial techniques, so it may represent a novel alternative     approach for somatic analgesia after major abdominal surgeries. Although patients with rectus     sheath block may experience some visceral pain, it is usually minimal by 24 hours after     surgery.   "
47749|NCT02660619|"     The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance     use disorder.   "
47737|NCT02660775|"     In people with schizophrenia or people with autism, impairments of social cognition are a     core feature of the disease and, according to researchers who represent valuable references     on this subject for the international community, three to five processes of social cognition     are usually altered in those diseases: (1) emotional processing which is the ability to     identify emotions through facial expressions, gestures, and tone of voice, (2) theory of mind     (ToM), which is defined as the ability to attribute mental states (beliefs, intents,     desires, …) to oneself and others, and to understand that others have beliefs, intentions,     and desires that are different from one's own, (3) attributional style which refers to how     people explain the causes of positive and negative events, and corresponding, in     schizophrenia, to self-serving and personalizing bias that means a tendency to blame others     for negative life events rather than sharing the responsibilities between different sources;     and (4 and 5) social perception and knowledge, which can be defined as decoding and     interpreting social cues from others, taking the social context into account, and knowing     social rules, roles, and goals. Components of social cognition appear to be related to both     symptomatology and functioning in everyday life. The present study aims to assess a new     social cognitive battery developed by several teams in France: ClaCoS.   "
47738|NCT02660762|"     This prospective study was conducted to evaluate the efficacy and safety profiles of Modified     MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia     chromosome negative acute lymphoblastic leukaemia.   "
47739|NCT02660749|"     Non Coronary Heart Surgery scheduled for the study , in patients with acute postoperative     period Use of tramadol retard, metamizol and dekxketoprofen the effects on pain and character     has been seen in the chronic phase targeted.   "
47740|NCT02660736|"     Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed     and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized     albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen     injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will     enable the use of a liquid product in a ready-to-use single dose auto-injector. To support     the development of the liquid auto-injector product, this healthy volunteer bioequivalence     study will be conducted to compare the liquid drug product to the currently available     lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose,     2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics     and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial     lyophilized drug product.   "
47741|NCT02660723|"     The main goal of this study is to investigate the impact of aging on the responsiveness of     peripheral blood immune cells. To this aim, the investigators will take advantage of a     recently described syringe-based assay system that can reproducibly assess induced, innate or     adaptive immune responses. Briefly, a total of 50 healthy volunteers will participate to this     study: 25 will be older than 18 and younger than 30, and 25 will be older than 55. A total of     14 ml of blood will be drawn including 5 X 1 ml in TruCulture™ tubes containing poly(I:C),     R-848, LPS, CpG, or no stimulus, respectively. After 22 hours of incubation at 37°C, cellular     supernatants will assessed for levels of 10 different chemokines using a MesoScaleDiscovery     multiplexing platform.   "
47742|NCT02660710|"     The purpose of this study is to establish the safety of rituximab plus cyclophosphamide,     doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse large     B-cell lymphoma (DLBCL) patients in Malawi.   "
47743|NCT02660697|"     The present retrospective study aims at assessing the clinical effects of a novel implant     site development (Extraction site development - XSD) technique after tooth extraction     compared with extraction alone in patients requiring dental implant placement following     healing of extraction sockets.   "
47744|NCT02660684|"     The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf     capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in     patients who received peripheral hematopoietic stem cell transplantation from a sibling     donor, and to compare with data from a historical control group that administered a     conventional Cyclosporine formulation.   "
47745|NCT02660671|"     This is an RCT aimed at testing different population-based approaches to increasing     colorectal cancer screening through email outreach, including usual email communication,     active choice, and active choice + financial incentive.   "
47746|NCT02660658|"     Spinal anesthesia is a commonly used technique for lower limb surgeries offering better     quality of postoperative analgesia, lower incidence of side effects, and shorter     post-anesthesia care unit stay than general anesthesia. However, the relatively short     duration of action of the currently available local anesthetics (LAs) make these advantages     short-lived.      The risk for local anesthetic toxicity (LAST) increases with the trials to use higher     concentrations or volumes of intrathecal local anesthetics to increase the duration of     analgesia.      Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without     the need for using high doses of local anesthetics and hence with decreasing the potential     risk of local anesthetic, but the increased likelihood adverse effects such as short term     bradycardia and prolonged duration of motor block may offset these benefits.   "
47747|NCT02660645|"     Registry study to gather more information on the current use of Blue Light Cystoscopy with     Cysview (BLCC) in urologists' practices.   "
47774|NCT02660294|"     Successful embryo implantation needs an optimum embryonic development with a receptive     endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The     aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison     with standard hormonal therapy.   "
47750|NCT02660606|"     The purpose of this study is to evaluate the patient usability and reliability of the POMAQ     survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain,     including patients who are opioid abusers, non-abusers, as well as non-opioid users   "
47863|NCT02659124|"     This is a comparison trial with novel application of AmnioFix and a control arm. Patients     electively being treated with facial lasers will be assigned to receive AmnioFix in addition     to the normal standard of care placed on half of their face after laser procedure, and normal     post laser standard of care alone on the other half of their face. The investigators will     investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic     factors. The study is designed to compare AmnioFix to the current standard of laser care.   "
47751|NCT02660593|"     MedlinePlus related topics: Blood Sugar      Primary Outcome Measures:        -  Fast glucose and HbA1c change between the baseline and end of study [ Time Frame: From          baseline to 30 and 100 days]        -  [ Designated as safety issue: No ]        -  Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [          Time Frame: From baseline to 30 days and 100 days] [ Designated as safety issue: No ]      Secondary Outcome Measures:      • To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36     [ Time Frame: From baseline to month 1 ] [ Designated as safety issue: No ]   "
47752|NCT02660580|"     The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022     and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.   "
47753|NCT02660567|"     The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a     randomized controlled, multi-centre study that aims to compare the incidence of post partum     hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's     maneuver with active management of the third stage versus active management alone   "
47754|NCT02660554|"     The purpose of this study is to conduct a randomized clinical trial to compare an antibiotic     strategy based on a novel diagnostic test, polymerase chain reaction (PCR) to usual care, in     critically ill adults with pneumonia suspected to be caused by methicillin resistant     staphylococcus aureus (MRSA). The investigators hypothesize that when automated PCR is used     to guide antibiotic therapy, antibiotic exposure will be reduced in critically ill subjects     with pneumonia.   "
47755|NCT02660541|"     This is a randomized, controlled, multi-centre, open-label study.      A total of 40 patients will be enrolled in this study. Patients will be randomly assigned to     Betafoam® or Allevyn® Silver dressing for burn wounds after acute burn injury.   "
47756|NCT02660528|"     This proposed study sets out to examine the antidepressant effects of tocilizumab among     patients with treatment-refractory major depression.   "
47757|NCT02660515|"     Open reduction and internal fixation of intra-articular distal radius fractures leads to     better functional outcomes the first 6 months compared to non-operative treatment. However,     some patients continue to have a painful and stiff wrist post-operatively. Arthroscopically     assisted removal of intra- articular fracture haematoma and debris may reduce pain and     improve the functional outcomes following operative treatment of intra-articular distal     radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence     of associated ligamentous injuries can be assessed. Therefore the objective of this study is     to compare the functional outcome of internal plate fixation with additional wrist     arthroscopy versus conventional fluoroscopic assisted internal plate fixation in adult     patients with displaced intra-articular distal radius fractures.   "
47758|NCT02660502|"     This is a double-blind, randomised, three period crossover phase 1 trial using automated     8-hour euglycemic clamps in healthy Japanese subjects.      Each subject will be randomly allocated to one out of nine sequences to receive either three     single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single     doses of BioChaperone insulin lispro on three separate dosing visits.      The total trial maximum duration for a subject will be up to 10 weeks.   "
47759|NCT02660489|"     The aim of this study is to assess the effectiveness of a CRTH2 receptor antagonist, OC459,     in preventing or attenuating the symptoms of an asthma exacerbation after rhinovirus     infection. The study is a double blind, randomised trial in which half the subjects will     receive OC459 and the other half placebo, before being inoculated with rhinovirus, that would     normally induce a worsening of asthma symptoms i.e. an exacerbation.   "
47760|NCT02660476|"     QUDOS is a cross-sectional population study aiming to answer key questions about diabetes and     its complications in Qatar as well as identify factors associated with the development and     progression of diabetes complications.   "
47761|NCT02660463|"     The incidence of chronic thromboembolic pulmonary hypertension (CTEPH) after acute pulmonary     embolism ist not clear. It is estimated to be up to 3.8%. Prospective data registration does     not exist. Treatment of choice is pulmonary endarterectomy if the thromboembolic lesions are     surgically accessible. Otherwise interventional therapy by means of pulmonary     balloon-angioplasty (BPA) or medical therapy is indicated. In Germany, the majority of the     patients is referred to three CTEPH centers: Kerckhoff Clinic, Saarland University Hospital     and Hannover Medical School to evaluate the therapeutic options. Starting in January 2016 all     incident patients will be de-identified and included prospectively. Risk factors, outcome and     treatment will be documented.   "
47762|NCT02660450|"     Current literature report 3 ways to prescribe and control aerobic training. Such models     require comparison to determine if they really provide the same impact training in a     prescription. The aim of this study is to compare the results of different methods of     prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted by     perceived effort (PSE) as well as psychological responses activation, and feel depending on     the stimuli offered.   "
47775|NCT02660281|"     This study will be a single-center treatment protocol, designed to validate the process of     related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant     Unit.   "
47763|NCT02660437|"     Investigators wish to identify a relationship between substantial changes in carbon dioxide     partial-pressure (pCO2), which frequently occur during the transitions from rest to exercise     (ΔpCO2 >4 millimeters of mercury [mmHg] from baseline), and the prevalence of cognitive     dysfunction in COPD. In particular, it is anticipated to investigate the vascular effect of     pCO2 oscillations in the regulation of cerebral blood flow (CBF) during exercise and its     impact on cognitive function in Chronic Obstructive Pulmonary Disease (COPD). Furthermore,     this study aims to examine whether major pCO2 oscillations have prognostic value in cognitive     deterioration at 6, 12, and 18-month follow-up. In addition, the acute effect of 3-week     pulmonary rehabilitation (PR) on cognitive function will be explored. The evaluation of     cognitive function will be performed by the use of Standardized Mini Mental State Examination     (SMMSE), Addenbrooke's Cognitive Examination (ACE-R), Montreal Cognitive Assessment (MoCA),     and Telephone Interview for Cognitive Status (TICS) assessing several cognitive domains     (cognitive scores) whereas Stroop test [color reading interference] will be used for     measuring cognitive performance (Reaction-Time).   "
47764|NCT02660424|"     The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment of     osteoarthritis pain   "
47765|NCT02660411|"     Surgery is one of the major treatment methods for patients with malignant tumor. And, alone     with the ageing process, more and more elderly patients undergo surgery for malignant tumor.     Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous     anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. From     the point of view of immune function after surgery and invasiveness of malignant tumor cells,     propofol intravenous anesthesia may be superior to inhalational anesthesia. However, the     clinical significance of these effects remains unclear. Retrospective studies indicated that     use of propofol intravenous anesthesia was associated higher long-term survival rate.     Prospective studies exploring the effect of anesthetic choice on long-term survival in cancer     surgery patients are urgently needed.   "
47766|NCT02660398|"     This prospective study will take place at Harborview Medical Center (HMC) and the University     of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal     surgery. The purpose of this study is to identify if the use of a specific plan to managing     muscle relaxants will help decrease the risk of muscle weakness after general anesthesia with     muscle relaxation in a population of patients undergoing abdominal surgery.   "
47767|NCT02660385|"     Chronic insomnia may contribute to the development and exacerbation of heart failure (HF),     incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea,     anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and     subjective functional performance.      The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia     severity, sleep characteristics, daytime symptoms, and functional performance over twelve     months among patients who have stable chronic HF and chronic insomnia. The effects of the     treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be     examined.      A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive     behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF     self-management education.      Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of     sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete     self-report measures of insomnia, sleep, symptoms, and functional performance. In addition     the effects on symptoms and function over a period of one year.   "
47768|NCT02660372|"     The aim of this study is to show non-inferiority of two brands of simeticone in adult     patients suffering from functional dyspepsia.   "
47769|NCT02660359|"     The purpose of this study is to provide confirmatory evidence of the safety and efficacy of     two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary     incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to     spinal cord injury (SCI) or multiple sclerosis (MS).   "
47770|NCT02660346|"     Patients with MRSaB have high therapeutic failure rates and mortality rates. Recent studies     have shown that an elevated IL-10 level is an independent risk factor of mortality. It may     also serve as biomarker for very early risk stratification. The aim of this study is to     compare the outcomes for patients with elevated IL-10 levels (≥8 pg/ml) when treated with     standard antibiotic therapy (daptomycin or vancomycin) versus early aggressive therapy     (daptomycin with ceftaroline) for the treatment of MRSaB.   "
47771|NCT02660333|"     The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation     on inflammatory response and indicators of nutritional status in patients with morbid     obesity. Study hypothesis: Supplementation of 12 g/day of fructooligosaccharides (prebiotic)     or 12 g/day of fructooligosaccharides + strains of lactobacilli and bifidobacteria     (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute phase proteins,     cytokines, metabolic and anthropometric parameters in individuals with BMI ≥ 40kg/m².   "
47772|NCT02660320|"     Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous     epidermal cells suspension grafting versus dermabrasion using micro-needling technique +     autologous epidermal cells suspension grafting and dermabrasion using micro-needling     technique + placebo suspension grafting in stable vitiligo.      A total of 10 patients with stable non-segmental vitiligo will be included in the ITT     population.      In each patient, three separate test areas will be selected in the same part of the body.      One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension     alone and the two others will receive the epidermal cell suspension in hyaluronic acid after     pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his     own control.      Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week     after cell grafting.   "
47773|NCT02660307|"     This protocol proposes a well-being program based in stress reduction program for employees     of a company.      objectives: To evaluate the effects of a stress reduction program with a specific orientation     for workers and taught to them within their companies.      Methods: Participants with stress complaints were recruited and randomized into two groups:     group 1 (G1) received the intervention while group 2 (G2) did not. Both groups were evaluated     before the intervention (time 1 - T1); again after the eight weeks of the program for G1     (time 2 - T2); and then at the end of a second eight-week period during which G2 received the     intervention and G1 was simply instructed to maintain the practice they had learned without     further instruction (time 3- T3).   "
47776|NCT02660268|"     The main objective is to determine the contribution of a clinical pathway to improve the     effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical     cure. The hypothesis raised is that the implementation of a clinical pathway would improve     the performance of the medical and surgical management of chronic infections of prosthetic     hip.   "
47777|NCT02660255|"     This is an observational, open-label, flexible dose study that will prospectively and     longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant     epilepsies through a Physician Expanded Access Investigational New Drug protocol.   "
47778|NCT02660242|"     This project focuses on development of new strategy for the prevention of exercise-associated     hypoglycemia using mini-dose glucagon.   "
47779|NCT02660229|"     The purpose of this study is to compare of difference in NRS scores from baseline to the     completion of treatment (5 days) in patients taking morphine sulfate versus oxycodone     hydrochloride.   "
47780|NCT02660216|"     Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The     conventional approach is characterized by a vestibular incision extending from     molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved     chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective     separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone.     However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a     true pterygomaxillary osteotomy is not necessary to achieve successful disjunction.     Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the     so-called Twist technique, to a minimally invasive protocol, performing the complete Le     Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although     promising, the technique remains highly sensitive from a technical standpoint, and its true     accuracy has not been comprehensively evaluated.      The purpose of this study is to present and validate a minimally invasive approach towards Le     Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary     outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of     the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary     outcomes include the surgical time necessary to complete the procedure and the presence of     intraoperative and early postoperative complications.   "
47781|NCT02660203|"     Following thoracic surgery, pleural effusion in pleural cavity requires post-operative     drainage.      Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower     efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These     complications could be avoided by respiratory physiotherapy.      Forced expiration technic in ipsilateral decubitus is one of these technics but has never     been proved better than other technics regarding its efficiency.      The aim of the study is to compare the impact of such a technic on post operative thoracic     drainage after pulmonary, pleural or mediastinal pediatric surgery.   "
47782|NCT02660190|"     Photodynamic diagnostic (PDD) is a technique where a photodynamic drug is installed     preoperatively in the bladder. Mucosa cells with a higher metabolism than normal urothelial     cells, e.g. cancer cells, absorbs this drug which is utilized during cystoscopy where blue     light is absorbed by the drug, making the surgeon able to distinguish tumor cells from normal     cells and thus being able to identify flat lesions and small papillomas missed in white light     cystoscopy.      The use of PDD at this primary transurethral resection of bladder tumour (TURB) has been     shown to be associated with a lower recurrence rate within the first year, probably mostly     owing to a higher detection rate of small papillomas and dysplasia that therefore can be     relevantly treated at an early stage.      Despite the use of PDD at the primary TURB, a high number of patients experience an early     recurrence and patients with carcinoma in situ (CIS) treated with bacillus Calmette-Guerin     (BCG) may have recurrence of their CIS or recurrence of papillomas despite the peroperative     use of PDD.      Whereas the use of PDD is well established in the TURB setting, the use of PDD in the     follow-up setting with flexible cystoscopy in the outpatient clinic is not investigated.     Feasibility studies have been successful but the clinical relevance and benefits have not     been investigated so far.      Thesis The thesis of the study is that the use of PDD in the outpatient clinic in patients     with a high recurrence risk undergoing follow-up flexible cystoscopy will result in diagnosis     of papillomas earlier than by the use of conventional flexible cystoscopy in white light.     Thus, a higher number of tumours can be treated in the outpatient setting without the need     for procedures in general anesthesia. Furthermore, the number of follow-up cystoscopies can     be reduced if PDD is used at the first cystoscopy following TURB.      Aims To investigate whether the use of PDD when performing a flexible cystoscopy in the     outpatient clinic can reduce the number of recurrences of large size papillomas that cannot     be treated by simple fulguration without general anesthesia. Furthermore, to investigate     whether the use of PDD in follow-up cystoscopy in patients with earlier complete response to     BCG on CIS, can increase the detection rate of CIS recurrences.   "
47783|NCT02660177|"     This study aims to assess the PK parameters of metamizole following a single IV     administration of metamizole in children less than 6 years of age.   "
47784|NCT02660164|"     The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the     Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.   "
47785|NCT02660151|"     The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal     surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,     such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal     dystrophies as well as post-surgical conditions resulting from cataract extraction and     corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and     disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care     professional.      In addition Hyper-CL™ contact lenses can also provide optical correction during healing if     required.   "
47786|NCT02660138|"     The purpose of this study is to provide confirmatory evidence of the safety and efficacy of     two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in     reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor     overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).   "
47787|NCT02660125|"     Midluteal single endometrial strip will be taken using a Novak curett under general     anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of     forbidden cervix, the step that will be beneficial to embryo transfer procedure.      Controller ovarian hyperstimulation; will be done using the long luteal phase agonist     protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3     FSH and antral follicular count and previous history of ovarian response).      Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when     there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval     will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after     oocyt retrieval according to number and quality of embryos.      Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test     will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.   "
47789|NCT02660099|"     The aim of this study is to test the feasibility and acceptability of an internet-delivered     cognitive behavior therapy (ICBT) intervention originally developed for neurotypical     adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism     spectrum disorder (ASD). This feasibility study will inform us how to adapt the original     intervention to the specific needs of patients with ASD.   "
47790|NCT02660086|"     This project tests a scalable and sustainable approach to weight gain prevention in a     population of employees by using the worksite environment to deliver personalized feedback     about worksite food purchases, daily calorie goals, social norms for healthy eating, and     financial incentives for healthy food purchases. In the future, similar strategies could be     adopted by other worksites, institutions, and food retailers and could contribute to the     long-term environmental and social changes needed to reverse the obesity epidemic in the     United States and worldwide.   "
47791|NCT02660073|"     Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian     and military personnel in the United States. Spinal cord injuries (SCI) predispose     individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing     them at greater risk for diabetes and coronary artery disease. These are devastating problems     that occur frequently because of changes in body composition and reduced level of physical     activity. Skeletal muscle wasting plays a central role in altered metabolism after SCI.     Functional electrical stimulation (FES) is an effective rehabilitation tool that has been     used to train the paralyzed skeletal muscles and which has shown some ability to ameliorate     the deleterious effects of SCI on metabolism, particularly on insulin sensitivity. However,     its ability to reverse skeletal muscle wasting is modest; most studies report limited gains     in muscle mass and workload with highly variables outcomes from one study to another. This     proposal was stimulated by the findings that a program of neuromuscular electrical     stimulation resistance exercise prior to initiating functional electrical stimulation lower     extremity cycling (FES-LEC) improves the gains in muscle mass and workload observed with FES.     The specific objectives for the current proposal are to compare the impact of FES following     evoking skeletal muscle hypertrophy of the lower extremity versus initiating FES cycling     without introducing the hypertrophy effects on insulin sensitivity, control of blood sugar     levels, oxygen uptake and amounts of muscle tissue and fat deposition. These studies could     potentially have significant effects on thousands of people that will experience an SCI in     the future as well as those living with SCI where prolonged paralysis is a major quality of     life issue.      There is a major need to investigate the mechanisms lead to maximize the benefits of FES     applications and to understand cellular or molecular events that are associated with muscle     hypertrophy and lead to promoting metabolic health after SCI. The designed study will provide     a greater understanding regarding utilization of energy sources (like fats and sugars) in     muscle   "
47792|NCT02660060|"     The present study was conducted to find out whether the bioavailability of 0.25 mg     pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was     equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH &     Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).   "
47793|NCT02660047|"     Among South Asians, in comparison to Western Europeans, there is an increased risk of type 2     diabetes mellitus (DM2) and DM2-related cardiovascular disease. The effect of Liraglutide     (Victoza®) on cardiovascular function is therefore investigated in the DM2 patient group of     South Asian descent specifically.      Liraglutide is a new widely prescribed therapeutic agent for DM2 patients. It is a Glucagon     Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and     body weight. The disadvantageous metabolic phenotype as seen in South Asians includes a     relatively large total fat mass, with predominately visceral relative to subcutaneous adipose     tissue and lower brown adipose tissue volume and activity, accompanied by increased lipid     levels. The key elements in the mechanism of action of Liraglutide seem to correspond to the     differences in metabolic profile between South Asians and Western Europeans. Diastolic     dysfunction, an early finding of cardiovascular disease in DM2 and obesity and an independent     predictor of mortality, has been shown to be associated with the amount of triglyceride     accumulation in the heart and liver. The investigators hypothesize that Liraglutide has     direct advantageous cardiovascular effects and reduces triglyceride accumulation in     end-organs, specifically for DM2 patients of South Asian descent.   "
47794|NCT02660034|"     The Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody     BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid     Tumors   "
47795|NCT02660021|"     Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and     face that are related to structure or growth malfunctioning, orthodontic problems, or     co-morbidities associated with skeletal disfigurement.      Imaging is crucial in the assessment and treatment planning of orthognathic surgery patients.     Until recently, two-dimensional (2D) imaging, through cephalometry, was standard practice.     However, it showed several limitations. The introduction of the cone-beam computed tomography     (CBCT) enabling three-dimensional (3D) imaging has caused a paradigm shift. Though widespread     implementation in routine practice is not yet present. Our department is one of the pioneers     in the world of 3D virtual treatment planning for orthognathic surgery. The triple CBCT scan     procedure has been developed in-house and implemented already in 2009.      The investigators aim to develop a prospective database registering 3D treatment planning     data of all consecutive patients eligible for orthognathic surgery, performed by Prof.     Swennen. Patient demographics, detailed virtual 3D treatment planning parameters and     orthognathic surgery data are being collected during consecutive visits within the framework     of routine practice.      Development of a database registering 3D virtual treatment planning data of orthognathic     surgery, will provide more information about potential patient, virtual planning and surgical     factors influencing postoperative accuracy of jaw correction, long-term stability of the     jawbone, long-term condylar resorption, or soft tissue response. In general, it could provide     answers on research questions that have been examined in prior studies on 2D-imaging, but can     now be re-examined in case of 3D-imaging. Moreover, registration of those results could     function as a measurement of quality of care, or could be used for sample size calculation     for future large multicenter prospective trials.   "
47796|NCT02660008|"     The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and     cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic     Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as     compared to marketed glucagon.   "
47804|NCT02659891|"     The overall goal of this study is to rapidly improve clearance of BK viremia with     Immunoglobulin (Privigen®) thereby decreasing the potential for formation of alloantibodies     in renal transplant recipients that have had immunosuppression reduction due to BK viremia.     Our approach is to perform a prospective, randomized, placebo controlled trial intravenous     immune globulin (IVIg; Privigen®) plus protocolized immunosuppression reduction versus     placebo and protocolized immunosuppression reduction in patients with BK viremia post-kidney     transplantation.   "
47832|NCT02659527|"     This diagnostic clinical trial will be conducted according to a randomized, prospective,     controlled, double-arm, single-centre design. The control will be implemented by comparing     the PET/MRI results with the histopathological finding after radical prostatectomy (positive     state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and     standard biopsy are negative (negative state) and/or the detection of a biochemical tumor     relapse (rising PSA after PSA nadir; secondary objective).   "
47819|NCT02659696|"     Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan,     and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for     pruritus in patients with chronic liver diseases including PBC. In the current study, the     investigators aimed to assess pruritus and overall QOL before and after administration of     nalfurafine hydrochloride in patients with PBC. Furthermore, the investigators took serum     sample from the enrolled patients and examine the association of pruritus with possible     biomarkers.   "
47820|NCT02659683|"     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Magnesium DR     Capsules 40 mg and Nexium® 40 mg DR Capsules of AstraZeneca LP, USA. Dosing periods of     studies were separated by a washout period of 4 days.   "
47797|NCT02659995|"     Our multicenter prospective observational study aims to show the relationship between blood     glucose levels and glycemic variability and the development of infections during the ICU stay     and with outcome. Within the secondary endpoints, we will evaluate if a blood glucose range     between 70 and 140 mg/dl is associated with an increasing surviving rate in non-diabetic     critically ill patients.      MATERIALS AND METHODS Multicenter study (ICUs of some Italian University Hospitals). Written     informed consent will be request before the inclusion of each patient in the study; if it     will not be possible, an informing module will be given to the patient's family and the     informed consent will be request to the patients as soon as possible.      Inclusion criteria: 300 patients consecutively admitted in each ICU from January 2016 and not     later than 31/03/2017.      Exclusion criteria: age < 18, end-stage disease. Data collection An Excel database will be     edited with these data about each patient: age, sex, type I or II diabetes, glycated     hemoglobin, at-home antidiabetic therapy; admission diagnosis, admission SAPS II score; daily     insulin administration (dose and route of administration, time of start, dose at the moment     of glycemic measurement and min-max daily range); steroid therapy (molecule, daily dose, date     of start and stop); antibiotic therapy (molecule, daily dose, date of start and stop); daily     caloric and protein intake and type of nutrition; other therapies; mechanical ventilation     (date of start and stop); blood lactates (worst daily value); daily leucocytes and     differential white cells count; daily SOFA score; presence of infections (suspected or     confirmed; site and microorganism and eventual Multidrug Resistance pattern); presence of     sepsis (following SCCM criteria); length of ICU and hospital stay; outcome (ICU and hospital     mortality).      Every blood glucose level measurement obtained will be registered with date and time.      Glycemic variability will be evaluated in terms of:        -  Standard deviation (SD)        -  Mean Amplitude of Glycemic Excursions (MAGE);        -  Coefficient of Variation (CV);        -  Glycemic Lability Index (GLI). STATISTICAL ANALYSIS Data analysis will be performed with          Kolmogorov-Smirnov test; parametric and non-parametric s tests, t-test (or Mann-Whitney          test), ROC Curve, binary logistic regression. Subgroups analysis.      Statistical significance: p < 0,05. SAMPLE SIZE 3300 patients.   "
47798|NCT02659982|"     The aim of this study is to evaluate the relevance of the information as provided by the     EarlySense Home care Tele-monitoring system can provide relevant flagging information for     clinicians to identify the patients at higher risk to proactively assess patients' condition   "
47799|NCT02659956|"     Background:      Multiple sclerosis (MS) is a disease that damages the central nervous system (brain and     spinal cord). This leads to increased physical disability over time. The disease is lifelong     once it begins. Researchers want to learn more about MS s stages and follow them until a     person s death.      Objective:      To understand how the physical and clinical signs of MS relate to its changes over time.      Eligibility:      Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like     MS.      Design:      Participants will have a medical history and a complete neurological exam. They may have     timed tests of neurological function, such as a 25-foot walk and a 9-hole peg test.      Participants will have multi-day visits about once a year.      Participants will have blood drawn.      Participants may have a brain magnetic resonance imaging (MRI) scan. They may also have an     MRI of the spinal cord. They may get a contrast agent (dye) injected into a tube in an arm     vein. During the MRI, participants will lie on a table that slides in and out of a metal     cylinder.      Participants will have the thickness of their retina measured using optical coherence     tomography. A camera on top of a table uses lasers. Participants will look through a lens and     follow instructions. Eye drops may be used to dilate the pupils.      Participants will chew on a piece of sterile cotton for 1 minute to collect saliva.      Participants agree to have an autopsy at the time of their death and to donate some of their     organs to research, such as the brain and spinal cord.   "
47800|NCT02659943|"     Background:      The immune system fights infection and can affect cancer cells. T cells are white blood cells     that are a major part of the immune system. T cells can destroy tumors. Researchers want to     try to manipulate the immune system to better recognize and kill tumor cells.      Objective:      To test the safety of giving T cells expressing a novel fully-human anti-CD19 chimeric     antigen receptor (CAR) to people with advanced B-cell cancer.      Eligibility:      People ages 18 73 with a B-cell cancer that has not been controlled by other therapies.      Design:      Participants will be screened with:      Physical exam      Blood and urine tests      Heart tests      Bone marrow sample taken      Scans in machines that take pictures      Participants will have apheresis. Blood is removed through a needle in an arm. T cells are     removed. The rest of the blood is returned through a needle in the other arm.      The cells will be changed in a laboratory.      Participants will get 2 chemotherapy drugs over 3 days.      Two days later, participants will check into the hospital. They will get an intravenous (IV)     catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion.      After this, participants will stay in the hospital for at least 9 days and stay nearby for 2     weeks. Then they will have blood tests and see a doctor.      Participants will have visits 6 visits for 1 year after the infusion. Some may have more     follow-up visits.      Participants may samples taken of spinal fluid, bone marrow, and tumors.   "
47801|NCT02659930|"     Background:      Kaposi sarcoma (KS) is a cancer most often seen in people with HIV. It causes lesions. These     are usually on the skin but sometimes in the lymph nodes, lungs, and gastrointestinal tract.     Researchers think a combination of drugs may help treat KS.      Objective:      To test a combination of the anti-cancer drugs pomalidomide (CC-4047) and liposomal     doxorubicin (Doxil) in people with KS.      Eligibility:      People ages 18 and over with KS      Design:      Participants will be screened with:      Medical history      Questionnaires      Physical exam      Blood, urine, and heart tests      Chest X-ray      Biopsy: A small sample of tissue is taken from a KS lesion.      Possible CT scan      Possible exam of lungs or gastrointestinal tract with an endoscope: A flexible instrument     examines      inside the organ.      Participants will take the drugs in 4-week cycles. They will take Doxil through an IV on Day     1 of each cycle. They will take CC-4047 tablets by mouth each day for the first 3 weeks of     each cycle.      Participants will have many visits:      Before starting treatment      To start each cycle      Day 15 of first 2 cycles      Visits include repeats of screening tests and:      Multiple blood draws      Photographs of lesions      Participants will keep a drug diary.      Participants will take aspirin or other drugs to prevent blood clots.      Participants with HIV will have combination antiretroviral therapy.      Some participants will have a PET scan.      Participants will continue treatment as long as they tolerate it and their KS improves. After     treatment, they will have several follow-up visits for up to 5 years   "
47802|NCT02659917|"     The purpose of this randomized clinical trial was evaluate the performance of two     conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative     treatment in high caries risk children.   "
47803|NCT02659904|"     Our primary objective in this clinical intervention study, therefore, was to explored the     effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6     months after free gingival graft harvesting in order to determine as soon as possible to     re-harvest gingival graft from same site.   "
47805|NCT02659878|"     Pupose:      Takotsubo cardiomyopathy is a rare and not well-known complication of the subarachnoid     hemorrhage.      This form of heart failure, called as broke heart or apical ballooning syndrome, was     first described by Japanese authors at the beginning of 1990's.      1.5-2.2% of acute coronary syndrome is Takotsubo cardiomyopathy. Its predisposing factors,     hypothetical parthenogenesis, diagnostic criteria and therapeutic methods are already known     from the literature.      The study intends to include all patients over 18 years of age who were admitted to our     clinic within 48 hours after the bleeding regardless of gender, neurological status or age.      Data to be registered within 24 hours after admittance:      Instruments:        -  Intracranial blood flow characteristics:TCCD - using Transcranial Color Doppler;          systolic, diastolic and mean blood flow velocity, Systolic / Diastolic ratio,          pulsatility index        -  ECG abnormalities: Corrected QT Interval (QTc), T wave, ST segment, arrhythmia        -  Echocardiography (Ejection fraction%, exact location and degree of cardiac wall motion          abnormalities) - documented with video recording      Hypothesis:      The risk of Takotsubo cardiomyopathy (TS) is increased if SAH is associated with more severe     state, a greater degree of bleeding, intraventricular and/ or intracerebral hemorrhage.      The definitive care of patients is postponed due to the appearance of TS, which could affect     the final outcome.   "
47806|NCT02659865|"     The main purpose of this study is to investigate the safety of the study drug known as     LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part     A has three periods. Either LY3039478 or placebo will be given once by mouth in each period.     Part B has two periods. Participants will receive both formulations of LY3039478, by mouth,     over the course of the study. Both parts of the study will also explore how much LY3039478     gets into the bloodstream and how long it takes the body to get rid of it. Information about     any side effects will also be collected. Participants may only enroll in one part. The study     will last at least 33 days, not including screening. Screening must be performed up to 30     days before enrollment.      Part B was added by protocol amendment approved in April, 2016.   "
47807|NCT02659852|"     Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma,     GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with     placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in     these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted.     There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant     obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show     the superiority of bilateral metal stent insertion between stent in stent and side by side.     Biliary drainage and stent patency was a little superior in side by side than stent in stent.     But, complication related with bilateral metal stent was increased in patients with side by     side method. Another study showed that there was no significant difference between those     bilateral stent insertion methods. The most important concern about side by side method is     associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent     insertion method in patients with hilar malignant biliary obstruction is still controversial.      The purpose of this study is to investigate the patency of stent and survival of patients in     side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD     type) in patient with hilar malignant biliary obstruction.   "
47808|NCT02659839|"     The purpose of this study is to determine 30 day mortality in cancer patients admitted to the     intensive care unit in a resource limited setting.   "
47809|NCT02659826|"     A crossover trial with healthy volunteers will be conducted. Six sessions will be performed     once a week in a counterbalanced order and at least with seven days washout period to     minimize carry-over effects. In each session, volunteers will be submitted to quantity and     quality of sleep, type of eating, fatigue and motivation level, cortical brain activity     measures through paired pulse transcranial magnetic stimulation (ppTMS), spinal cord activity     measures through electrical stimulation, non-invasive spinal stimulation (tsDCS) or     non-invasive brain stimulation (rTMS) and physical exercise (gait training).   "
47810|NCT02659813|"     This study protocol is for a randomised clinical trial which aims to test two materials used     as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi)     archwires. Both professional and patient related outcome measures are to be used to fully     evaluate performance.   "
47811|NCT02659800|"     This pilot, partially randomized clinical trial studies how well glycosylated recombinant     human interleukin-7 works in increasing low cluster of differentiation (CD)4 counts after     concurrent radiation and temozolomide treatment in patients with gliomas that tend to grow     rapidly and spread (high-grade). Treatment with radiation and chemotherapy, such as     temozolomide, may cause an abnormal decrease in CD4 cells, which are an important part of the     immune system. Glycosylated recombinant human interleukin-7 may increase CD4 cell counts and     improve survival.   "
47812|NCT02659787|"     This study seeks to to study the effects of buprenorphine, a partial mu-opioid agonist, on     depressed mood in a healthy young adults with a range of depressive symptomatology.   "
47813|NCT02659774|"     This study has the following objectives:        1. To examine the employers'/managerial staff's knowledge, attitudes and practices in          promoting smoking cessation in workplace.        2. To evaluate the smoking behaviours of participants before and after attending a smoking          cessation intervention.   "
47814|NCT02659761|"     The purpose of this study is to assess the tolerability, adherence and efficacy of single     tablet dolutegravir/abacavir/lamivudine antiretroviral therapy in people living with HIV with     a history of injection drug use (IDU) switching from existing antiretroviral therapy (ART) or     starting treatment after discontinuation of ART.   "
47815|NCT02659748|"     This study investigates the effects of bioactive fatty acids in full fat dairy (whole     yogurt), on insulin action, calorie needs, blood lipids, immune function, and body     composition in normal and overweight male and female volunteers.   "
47816|NCT02659735|"     The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872     following administration of a single dose as three different concept formulations with that     following administration of the current formulation, under both fed and fasted conditions, in     healthy adult participants.   "
47833|NCT02659514|"     The purpose of this study is to evaluate the efficacy and tolerability of poziotinib in     patients with HER2-positive metastatic breast cancer who have received at least 2 prior     HER2-directed treatment regimens.   "
47821|NCT02659670|"     An investigator-blinded, prospective, 6 month study of subjects with persistent erythema     associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All     subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to     apply it once daily per package insert. Adherence will be assessed using weekly internet     surveys to document how often the medication is being used, as well as reminders about     rosacea triggers and general use of brimonidine.      Subjects with persistent erythema associated with rosacea will be recruited from the Wake     Forest Baptist Health Dermatology Clinics and IRB approved advertising. At the baseline     screening visit, subjects will have the diagnosis of rosacea confirmed by an investigator.     Subjects will be classified as having erythematotelangiectatic or a combination     erythematotelangiectatic and papulopustular. Study staff will evaluate whether subjects     believe they have constant erythema or more intermittent flushing and blushing. Subjects will     be informed of the benefits and risks of treatment. If they agree to participate, the     subjects will give written consent approved by the Institutional Review Board and will be     seen in follow up at 3 months and 6 months.      Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard     care non-survey group. The internet survey will ask them how often they have used their     medication that week, as well as giving them treatment tips and reminders about rosacea     triggers. Subjects will be asked a variety of questions during the weekly internet survey;     such as the amount of erythema they currently have (measured by VAS scale), how much burning     and stinging they have, how often they have used the medication and where did they apply the     medication, as well as any additional side effects they may be having from the medication.      Subjects in the non-internet survey group will just get these identical surveys at the Month     3 and Month 6 visits. The Investigator is also interested in learning through the adherence     surveys if subjects begin using the medication on an as needed basis, and if this affects the     side effect profile and satisfaction with the medication.   "
47822|NCT02659657|"     The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow     transplantation (HBMT) on hematological malignancies are well established.The aim of this     prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be     decreased with IL2 therapy post HBMT.   "
47823|NCT02659644|"     Sickle cell disease is a genetic red blood cell disorder that can result in blocking of the     small blood vessels from sickle shaped red blood cells. This causes pain, the main feature of     sickle cell disease. Also, low amounts of nitric oxide can occur in sickle cell disease, a     substance important for widening the blood vessel wall and therefore preventing blockage of     the small blood vessels.      Citrulline is a drug that is known to increase nitric oxide. This is a phase I study of     citrulline given by mouth to evaluate the safety, tolerability and appropriate dosing of this     medication for individuals with sickle cell disease.   "
47824|NCT02659631|"     The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses     of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin     expression. The study will then expand to look at the selected dose in patients with     P-cadherin expressing TNBC, CRC or NSCLC.   "
47825|NCT02659618|"     The goal of this study is to identify a serum biomarker(s) that can detect increased levels     of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the     blood of patients with severe persistent asthma.   "
47826|NCT02659605|"     The purpose of this study is to determine if delayed cord clamping above the perineum has an     effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in     pre-term spontaneous vaginal deliveries.   "
47827|NCT02659592|"     Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology     centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed     ovarian tissue, with the aim to conceive.      Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine     monitoring, IVF.   "
47828|NCT02659579|"     The investigators will evaluate the effectiveness of a parent-child shared reading     intervention run by The Reader Organisation. The investigators will be asking parents and     children across Liverpool to either (i) attend a weekly shared reading programme or (b) to     attend a weekly children's reading group at a library. The investigators will look at how the     reading groups affect children's language development, by comparing children's language     development before having gone to these groups and after they have attended these groups.   "
47829|NCT02659566|"     Background:      Malaria is a disease that affects many people in the country of Mali and other parts of     Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can     also be serious or can lead to death if not diagnosed and treated promptly. Children younger     than 5 years and pregnant women are at highest risk of malaria. Researchers want to better     understand how malaria infection suppresses the immune system. They want to compare a group     of adults who receive antimalarial treatment to a group that does not receive it.      Objective:      To investigate the effect of antimalarial treatment at the beginning of the dry season on the     immune system and malaria episodes.      Eligibility:      Healthy adults ages 18 60 who live in the area of Doneguebougou, Mali.      Design:      Participants will be screened with a physical exam and health questions.      If participants are found to be sick at the screening visit, they will get initial care at     the study clinic free of charge. They may get referrals for consultation.      Participants will be randomly assigned to a group. One group will get an approved     antimalarial drug called Coartem . The other will not receive it.      Participants in the Coartem group will take the drug for 3 days.      All participants will have blood tests.      Al participants will be seen about once a month for about 1 year. At each visit, they will be     asked how they are feeling and be examined. Blood will be drawn.      If participants become sick at any time, they will come to the clinic to be examined.   "
47830|NCT02659553|"     1. Clinical impact of graft steatosis on postoperative complications after OLT.        2. Recommendations to improve outcomes after transplantation of steatotic livers and          increase donor pool.   "
47831|NCT02659540|"     This is an open-label, multicenter pilot Phase 1 study of the checkpoint antibodies     ipilimumab and nivolumab in combination with radiotherapy in 18 subjects with unresectable     stage IV melanoma. All subjects will receive concurrent ipilimumab (3 mg/kg) and nivolumab (1     mg/kg) every 3 weeks for 4 doses, followed by nivolumab monotherapy (3 mg/kg) every 2 weeks.     Radiotherapy will be initiated after the first dose and before the second dose of     immunotherapy.   "
47834|NCT02659501|"     Objectives:        1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.        2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and          opioid related adverse events.        3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.        4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with          postoperative pain control.        5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.   "
47835|NCT02659488|"     The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain     Dysfunction in Binge Eating Disorder   "
47839|NCT02659436|"     The purpose of this pilot study is to explore whether there is a differential impact of     verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation     strategy for individuals with social anxiety disorder (SAD). Clients who have not     demonstrated clinically significant change following group CBT for SAD will receive four     additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that that     individuals who receive imagery-based CBT will experience even stronger improvements and be     more satisfied with their treatment than individuals who received traditional     verbal-linguistic CBT.   "
47840|NCT02659423|"     Bystander interventions, recognized as promising violence prevention strategies, are unique     in their engagement of all community members to 1) recognize situations that may become     violent and 2) learn to safely and effectively intervene to reduce violence risk. Based on     their promise, the Campus Sexual Violence Elimination Act (SaVE) now requires all     publicly-funded colleges to provide bystander intervention. With SaVE's policy intervention     requiring bystander interventions, a natural experiment has arisen to determine the     relative efficacy of students' bystander training across multiple colleges. Investigators     propose a quasi-experimental design (using fractional factorials) to evaluate the relative     efficacy of three bystander interventions to reduce violence in college communities. Green     Dot will be one of three bystander interventions evaluated. A recent rigorous evaluation has     found that Green Dot is associated with a 20-40% reduction in VAW in college and high school     settings.      In aim 1, investigators will compare the relative efficacy of bystander interventions to a)     increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce     interpersonal violence victimization and perpetration, and d) increase program cost     effectiveness. The three main bystander groups compared will be: exclusively online training,     Green Dot (speeches and intensive bystander training), and other skills-based bystander     training. Program efficacy data will be obtained from student surveys, campus crime     statistics, and surveys with college staff and administrators responsible for selecting and     implementing bystander interventions.      In aim 2, investigators seek to grow communities of VAW prevention researchers. Researcher     communities will form through researchers' engagement with college recruitment, survey     design, data collection and analyses. Specifically investigators will determine the efficacy     of this program to increase VAW prevention research productivity defined as a) increasing     research skills and b) increasing research communications measured as manuscript submissions,     presentations, and publications.      This natural experiment will generate new understanding into efficacy of how bystander     programs work. This natural experiment will also provide the VAW research community an     opportunity to increase our skill-sets and share our experiences with and help grow the next     generation of VAW prevention researchers.   "
47841|NCT02659410|"     In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds.     Exposure to heat induces physiological responses that help maintaining a stable body     temperature. Those changes can affect organ functions implicated in absorption and     metabolism. According to literature, those changes could lead to increased concentrations of     chemical compounds in the body and their toxicity. Therefore, the aim of this study is to     evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress     conditions in volunteers exposed in a inhalation chamber. Results will then be used to     develop PBPK models that will allow to predict organic solvent kinetics when coexposed with     heat.   "
47842|NCT02659397|"     The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in     the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol)     and other markers of health and disease in blood and urine, and to see how ETC-1002 is     tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background     therapy in statin-treated patients.   "
47843|NCT02659384|"     This is a randomized phase II study, aimed at evaluating the efficacy (through progression     free survival at 6 months) and safety of 5 different treatments involving atezolizumab,     bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian     cancer patients in order to select the optimal treatments for further development in Phase     III.   "
47844|NCT02659371|"     Due to a higher risk of complications, obese and overweight patients with macromastia are in     Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2.      The study is a pilot study with a diet intervention group and no control group. The     intervention is a 12 week low energy diet pre-operative weight loss program investigating if     this will result in weight loss making the overweight and obese patients eligible for breast     reduction surgery i.e. BMI < 25.   "
47845|NCT02659358|"     The purpose of this study is to evaluate the association between wearable biosensor data,     performance status and patient-reported outcomes in cancer patients. Participants in this     study will wear a biosensor (Fitbit Charge HR®) for 15 days and respond to questionnaires     that will assess patient reported outcome measures including physical function, emotional     distress, pain interference, sleep disturbance and fatigue.      Eligible patients will have a diagnosis of advanced cancer. Patients must be greater than 18     years of age and be English speaking due to the questionnaires that will be administered     during the study. Patients must also be ambulatory (use of walking aids, such as cane and     rollator, is acceptable) and have access to a smartphone with internet access (IOS or     Android). It is also necessary for patients to have scheduled oncology clinic visits at least     once every 2 weeks.   "
47846|NCT02659345|"     Participants in this research study are asked to tell about their experience with art     therapy. Participants in this research study are currently receiving chemotherapy treatment     for cancer. The purpose of this study is to learn how art therapy affects mood, anxiety,     pain, and emotions of individuals with cancer who are undergoing chemotherapy.   "
47859|NCT02659176|"     Comparison between transperineal repair of rectocele with or without posterior internal     sphincterotomy.   "
47847|NCT02659332|"     -  Primary Objective: To show that small pTa bladder tumors can be removed with diode laser          in an outpatient department.        -  Secondary Objective: To evaluate the patients' symptoms during and after the laser          TURBT.        -  Tertiary Objective: To evaluate the rate of remnant tumor tissue one month after the          laser TURBT.   "
47848|NCT02659319|"     The purpose of the study is to test the effectiveness of a child obesity intervention with     multiple components targeting nutrition and/or psycho-social factors in children, their     parents, and their classmates. The specific aims of the study are to (1) Determine the     effectiveness of two family-level interventions for improving child outcomes (unhealthy     eating, low activity, and overweight); (2) Determine the extent to which adding a family     dynamics component enhances the effectiveness of a family lifestyle intervention and improves     the child outcomes listed above; and (3) Determine the extent to which a peer-level     intervention improves the effectiveness of two family-level interventions among overweight     children.   "
47875|NCT02658968|"     This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory     diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum     tolerable dose of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who     are not eligible for autologous stem cell transplant. The study will also assess safety and     toxicity, pharmacokinetics, biodistribution and efficacy.   "
47849|NCT02659306|"     Anti-HIV drugs cut down the number of serious infections that people with HIV get. However,     some subjects taking anti-HIV drugs do not achieve adequate cluster of differentiation 4     (CD4) recovery and decrease in elevated cluster of differentiation 8 (CD8) cells. Such     patients with a low CD4/CD8 ratio remain at risk for developing acquired immune deficiency     syndrome (AIDS) and non-AIDS-related complications. Two of the most important factors     associated with low CD4/CD8 ratio include: the persistence of HIV on ART and inflammation.      Metformin, the most widely used medication to treat type 2 diabetes, is well tolerated with     minimal side effects. It has been linked to anti-aging and weight reducing properties in     non-diabetic persons. Because of its ability to improve immune functions, metformin could be     a promising addition to ART in HIV patients. It is also reported to change the composition of     microbes in the gut which may improve inflammation.      PURPOSES OF THE STUDY      The purposes of this study are to find out if:        1. metformin can be combined with anti-HIV drugs to reduce the amount of hidden virus in          the body;        2. metformin can be combined with anti-HIV drugs to improve immune function.        3. metformin can be combined with anti-HIV drugs to impact CD4 T cell count and CD4/CD8 T          cell ratio during treatment and after its discontinuation        4. metformin can change the composition of the bacteria in the gut which may improve          inflammation.      For this purpose, the investigators will add metformin at the usual antidiabetic dose for 12     weeks for patients receiving stable ART, having a CD4/CD8 ratio below 0.7.      Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness     Service of the McGill University Health Centre, the Ottawa Hospital and the Maple Leaf     Medical Clinic (Toronto). This study will last about 24 weeks; metformin treatment will be     for 12 weeks. In order to be eligible for the study, the participants must be 18 years of age     or older, have an undetectable viral load (the quantity of the HIV virus in the blood must be     less than 50 copies/ml) for at least 3 months and have a CD4/CD8 ratio of less than 0.7. All     participants will also be asked to give blood and stool samples and optional colon mucosal     biopsy samples (before and after metformin supplementation) to study the size of the viral     reservoir and the amount of T cell activation and changes in gut microbiota composition.   "
47850|NCT02659293|"     This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus     lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who     completed autologous stem cell transplant for symptomatic myeloma who are considered for     lenalidomide maintenance.   "
47851|NCT02659280|"     This study will take about 3-16 months. Participants will be inpatients in the Hennepin     Health System that are transitioning into outpatient or home health Physical Therapy or     current outpatient patients. Investigators will assess 24 participants for eligibility based     on the study's inclusion criteria. If eligible, Investigators will attain informed consent     and provide instruction on how to use a coaching app, Hudl Technique, and enter data in the     Apple Health Kit (all participants will be gifted an iPad mini 4, cover and Hudl Technique     app). Baseline Body Mass Index (BMI) will be taken and entered in the Apple Health Kit.     Randomization (1:1) will occur by an outside statistician. 12 patients will be allotted to     the control group (receive traditional OP PT and have access to the Apple Health Kit and Hudl     Technique with the gifted iPad). 12 patients will be the variable group (receive traditional     OP PT, have access to the Apple Health Kit and Hudl Technique with the gifted iPad, and have     an adjunct Home Exercise Program which will be administered via tele-health store and     forward technology 1x/wk). There will be an 8 week assessment in which Investigators plan to     measure 1) satisfaction with PT (via survey) 2) Home Exercise Program (HEP) compliance (via     survey) 3) incidents of ED visits or hospital admissions 4) BMI (via patient report with     option to put it in the Apple Health Kit). There will be a 24 week assessment in which     investigators will measure the same 4 measurements. Investigators plan on performing this     protocol for an additional 24 participants in late 2016/early 2017 (48 participants in     total). Unfortunately, this will be a non-blinded (assessor, therapist and participant) study     due to the nature of the intervention and how investigators received the funding. Casey Byron     will be the Principal Investigator. Investigators would like the statistician to be blinded     to group allocation until completion of the study (roughly 3/11/2017).   "
47852|NCT02659267|"     The study aims to verify if the VAMOS strategy contributes to an increase in physical     activity and healthy eating habits among users of the Health Academy Program from Belo     Horizonte, Minas Gerais.   "
47853|NCT02659254|"     This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular     Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time. The goal is     to access the preliminary safety and efficacy of Firesorb implantation in the human body, and     to provide evidence for subsequent large-scale, multi-center, randomized controlled clinical     trials. Then provide the basis for the formal application of the product in China.   "
47854|NCT02659241|"     The goal of this clinical research study is to learn if certain characteristics of DNA (the     genetic material in cells) affects how ovarian, fallopian tube, or primary peritoneal     carcinomas respond to therapy with AZD1775. Researchers also want to learn if treatment with     AZD1775 affects the DNA in cancer cells.   "
47855|NCT02659228|"     In this study, the investigators explore anesthesia as a tool for providing further insight     into the level of consciousness of individuals with a clinical diagnosis of unresponsive     wakefulness syndrome (UWS), but who possess some neurophysiological signatures of conscious     awareness. This group, who could potentially be conscious, will herein be referred to as the     target population. Our goal is to assess whether or not neurological patterns of     consciousness in the target population respond to anesthesia in a similar manner to     neurologically compromised individuals with known consciousness (e.g. those in minimally     conscious state (MCS). In healthy controls, propofol-induced unconsciousness results in an     elimination of the mismatch negativity event-related brain potential (ERP) and a diminished     directed connectivity. The investigators hypothesize that at doses well below those required     for surgery, anesthesia will have similar effects on these neural patterns in neurologically     compromised patients with the potential for conscious awareness, but will not affect these     patterns in those who lack consciousness.   "
47856|NCT02659215|"     The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with     bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of     symptomatic cartilage defects of the knee.   "
47857|NCT02659202|"     The purpose of this proposal is to determine whether epidural spinal cord stimulation can     modulate cardiovascular control during exercise in Heart Failure patients.   "
47858|NCT02659189|"     The purpose of this study is to create an institutional registry of Chronic Obstructive     Pulmonary disease through a prospective survey based on epidemiological data, risk factors,     diagnosis, prognosis, treatment, monitoring and survival.   "
47861|NCT02659150|"     The purpose of this study is to test the hypothesis that anti-IL-6 therapy is effective for     reducing plaque inflammation as measured by fluorine-2-deoxy-D-glucose positron emission     tomography (FDG-PET) in patients with rheumatoid arthritis (RA) who are synthetic     disease-modifying antirheumatic drugs (dMARD) inadequate responders and are naive to biologic     therapy.   "
47862|NCT02659137|"     TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers that     differ considerably between devices. There is an increased risk of progression to total     AV‐block at follow‐up, with the risk of brady‐arrhythmic death.      The aim of the study is to elucidate the anatomical location of the conduction pathology of a     TAVI induced LBBB. This could impact valve design and placement and thereby reduce the number     of new LBBB induced by TAVI in the future. Furthermore, finding predictors for progression to     a high degree AV block in the follow‐up (and thus an indication for permanent pacemaker)     could improve management of post‐operative conduction abnormalities and prevent the risk of     brady‐arrhythmic death.   "
47864|NCT02659111|"     Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties     regarding gait, balance, cognition and micturition. A shunt operation will improve these     difficulties in most cases. Data suggest however, that they do not change their physical     activity postoperatively. Physical training has been shown to be beneficial in patients with     similar diseases i.e. Parkinson. The aim of this study is to apply a high intensity physical     training program after a shunt operation to see if the patients can improve their physical     capacity and ambulatory activity more than patients who only receive standardized written     advice about physical training.   "
47865|NCT02659098|"     The purpose of this study is to evaluate the safety and performance profile of a modified     surgical procedure and custom Delivery System and also to assess the effects on best     corrected visual acuity of a single subretinal administration of CNTO 2476.   "
47866|NCT02659085|"     Developing more effective and faster acting antidepressant is of outmost clinical importance.     Available antidepressant therapies have a delayed therapeutic effect. It typically takes     several weeks before symptom relief is evident. Furthermore, antidepressants are relatively     ineffective - as many as 30% of patients do not respond to any medication at all. In this     study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new     antidepressant treatment for severely depressed patients and compare its effectiveness with     that of electroconvulsive therapy (ECT).   "
47867|NCT02659072|"     Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans     vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination     and probe disinfection. This will allow modeling the risk of HPV transmission, and could     contribute establishing future guidelines for reducing the risk of transmission of     microorganisms and the risk of infection through TVS.   "
47868|NCT02659059|"     The purpose of part 1 of this study is to determine the objective response rate (ORR) in     stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line     therapy.      The purpose of part 2 of this study is to compare overall survival of Nivolumab and     ipilimumab combined with a short course of chemotherapy to standard of care chemotherapy in     first line stage IV NSCLC.   "
47869|NCT02659046|"     The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment     methods on traumatic brain injury (TBI) patient prognosis.   "
47870|NCT02659033|"     CEREMI is an open, randomised prospective study in parallel groups in healthy volunteers.     This study compare the effect of a monotherapy by ceftriaxone or cefotaxime on the emergence     of resistance of enterobacteria to 3rd-generation cephalosporins within the intestinal     microbiota. Each volunteer will be treated for 3 days by either ceftriaxone (1 gram per day)     or cefotaxime (1 gram every 8 hours).   "
47871|NCT02659020|"     The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer     drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in     participants with advanced soft tissue sarcoma (STS) or STS that has spread to another     part(s) of the body.   "
47872|NCT02659007|"     The long-term goal is to identify and establish effective mind-body interventions (as an     aspect of complementary and alternative medicine) to improve health and Quality of Life (QoL)     for people with disabilities. Preliminary data suggest that engagement in yoga is feasible     and beneficial for multiple study populations, and it may relieve symptoms of neuropathy. The     central hypothesis is that individuals who complete yoga will have significantly better     balance, mobility, and QoL after 8 weeks of yoga.   "
47900|NCT02658643|"     The aim of this prospective randomized controlled study is to determine the benefit-risk     ratio (success rate, complication rate, tolerance) for patients with biliodigestive     anastomosis by either continuous or interrupted suture.   "
47911|NCT02658500|"     This study evaluates the early infant feeding in the infant intestinal microecology and the     long term health. 300 healthy term newborns were involved into the study on its first stage.     Depending on the type of feeding the infants were divided into 3 groups with random     allocation to one of the formula feeding groups: the group A included 100 infants consuming     the formula supplement with superior quality whey protein, the group B -100 infants fed with     a standard formula, and the group C -100 infants who were breastfed.   "
47873|NCT02658994|"     Background      The negative effects of perinatal depression on mother and child start early and persist     throughout the life-course. Given that 10-35% of children worldwide are exposed to perinatal     depression in their first year of life, 16 mitigating this intergenerational risk is a global     public health priority. However, there is a dearth of studies on whether a maternal     depression intervention can have long-term benefits for either the mother or her child. This     is a study of the effectiveness of an extended 36-month peer-delivered depression     intervention, the Thinking Healthy Programme PLUS (THPP+) for women and their children in     rural Pakistan.      Study Design      The THPP+ study aims to evaluate the effects of an extended 36-month perinatal depression     intervention on mother and child outcomes using a cluster randomized controlled trial (c-RCT)     design. The trial will recruit 560 pregnant women who screened positive for perinatal     depression (PHQ-9 >=10) from 40 village clusters, of which 20 clusters will receive the THPP+     intervention delivered by trained peers. These women will have already been participating in     the trial of the shorter, 6 month long, version of the intervention. Women in the THPP+     intervention arm will receive bimonthly group-based sessions. Primary outcomes are 3-year     maternal depression and 3-year child socio-emotional and cognitive development. All primary     analyses will be intention-to-treat and will account for the clustered study design.      Discussion      This trial has the potential to further significantly our understanding of whether     intervening on women's perinatal depression can mitigate the negative effects of maternal     depression on 36-month child development.   "
47874|NCT02658981|"     This phase I trial studies the safety and best dose of anti-LAG-3 (anti-LAG-3 monoclonal     antibody BMS-986016) or urelumab alone and in combination with nivolumab in treating patients     with glioblastoma that has returned (recurrent). Anti-LAG-3 monoclonal antibody BMS-986016,     urelumab, and nivolumab are antibodies (a type of protein) that may stimulate the cells in     the immune system to attack tumor cells. It is not yet known whether anti-LAG-3 monoclonal     antibody BMS-986016 or urelumab alone or in combination with nivolumab may kill more tumor     cells.   "
47876|NCT02658955|"     Implementing guidelines of EHS for abdominal wall closure in all specialities of a General     Hospital. Migrating from large stitch technique to short stitch technique.   "
47879|NCT02658916|"     The purpose of this study is to evaluate the long-term safety and tolerability of multiple     intravenous (IV) infusions of BMS-986168 in patients with Progressive Supranuclear Palsy     (PSP). The study will also assess the pharmacodynamic (PD) effects of BMS-986168 on     cerebrospinal fluid (CSF) extracellular tau (eTau), pharmacokinetics (PK), and immunogenicity     of BMS-986168 in patients with Progressive Supranuclear Palsy.   "
47880|NCT02658903|"     The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary     infections is studied.   "
47882|NCT02658877|"     The primary purpose of this study is to identify additional mechanisms of action of     omalizumab that will lead to improved stratification of patients for treatment. Understanding     the response of specific innate immune effector cells in the lung can provide clues to these     questions. Investigators will use non-invasive measures of a discrete cell population to     examine the downstream effects of omalizumab treatment in the lung. Information derived from     these studies will help clarify mechanisms of action of omalizumab and help identify     potential tools for patient endotyping and stratification for therapeutic interventions.   "
47883|NCT02658864|"     This study was to evaluate the pharmacokinetics of single and multiple doses of oral     lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects.     The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated     to acquire more pharmacokinetic information.   "
47884|NCT02658851|"     This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based     plasma technology in the reduction of lymphoceles following pelvic lymph node dissection     (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be     used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to     prevent lymph leakage.   "
47885|NCT02658838|"     The purpose of this study is to determine ticagrelor combining with low molecular weight     heparin is effective and safe during PCI or not.   "
47886|NCT02658825|"     The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at     supratherapeutic exposure in healthy participants (Panel 2).   "
47887|NCT02658812|"     The goal of this clinical research study is to learn if talimogene laherparepvec can help to     control recurrent (has come back after treatment) breast cancer. The safety of this drug will     also be studied.   "
47901|NCT02658630|"     The purpose of this study is to design a predictive model of stroke recovery based on     baseline measurements of arm movement and brain physiology. The expectation is the     development of a formula to predict a person's response to an arm rehabilitation program     provided in the chronic phase (6 months or greater post stroke) of recovery. The study will     include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic     testing using saliva, and an arm exercise program consisting of robot-assisted exercise     combined with functional arm exercise called transition to task training (TTT).   "
47888|NCT02658799|"     Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and     pain relief. However, while adjunct use of NSAIDs is avoided for periodontal therapy because     of related side effects, cyclic administration of NSAIDs may reduce or eliminate these     effects. The investigators evaluated the effect of a cyclic diclofenac potassium regimen on     clinical parameters and levels of prostaglandin E2 (PGE2) and interleukin-1beta (IL-1beta) in     the gingival crevicular fluid (GCF) of subjects with periodontitis. Forty-one subjects with     moderate to chronic periodontitis (33 men, 8 women) were divided into two groups (test and     control) after initial periodontal therapy. During this 6-month, randomized, double-blind,     placebo-controlled study, test (n = 28) and control (n = 13) groups were administered a     cyclic regimen of diclofenac potassium (50 mg, twice daily) or placebo. Clinical measurements     of disease severity and GCF sample collections were made at baseline, 2, 4 and 6 months. GCF     levels of PGE2 and IL1-1beta were determined using EIA and ELISA kits, respectively.   "
47889|NCT02658786|"     Chronic liver diseases of differing etiologies are among the leading causes of morbidity and     mortality worldwide [1]. Chronic liver disease progresses through different pathological     stages that vary from mild hepatic inflammation without fibrosis to advanced hepatic fibrosis     and cirrhosis [2]. Assessment of the stage of liver disease is important for diagnosis,     treatment, and follow-up both during treatment and after cessation of treatment. A liver     biopsy is the oldest and most accurate method used to evaluate liver histology and the     progression of chronic liver disease. Furthermore, different histological scoring systems     have been developed and modified [3]. A liver biopsy is considered the gold standard for     assessing liver histology [4]. During the pathological progression of liver fibrosis,     excessive amounts of extracellular matrix build up; furthermore, serum levels of various     biomarkers change, in addition to the appearance of new biomarkers in the serum during the     different stages of fibrosis [2, 5]. Recently many noninvasive markers (NIMs) for assessing     liver fibrosis have been developed, and they are frequently used in clinical practice. They     have been validated in different studies, and some were found to be highly accurate in the     assessment of liver fibrosis compared with liver biopsies [6-7], which have always been used     as the standard reference method for evaluating the accuracy of noninvasive methods. There     are limited studies documenting the cost effectiveness of non invasive markers over invasive     technique.      Most people with chronic Hepatitis B or C are unaware of their infection, putting them at     serious risk of developing cirrhosis or liver cancer which are life threatening. Similarly     patients with non alcoholic fatty liver diseases are unaware about fibrosis in liver. About     20-50% of persistent infection ends up into fibrosis and finally cirrhosis. Invasive and non     invasive diagnostic methods are widely used to detect the fibrosis. Clinicians use different     drugs and combinations to treat HBV and HCV infections. However, there is scarcity of a     longitudinal prospective study to assess the cost effectiveness of these diagnostic measures.      We planned to conduct a retrospective followed by prospective cohort study among all cases     that underwent biopsy in ILBS or GB Pant Hospital since 2000 till Dec 2020 with HBV     infection, HCV infection, or non alcoholic fatty liver disease. For retrospective cohort     study, we will collect data from hospital information system for all patients with HBV     infection, HCV infection, or non alcoholic fatty liver disease, who underwent biopsy during     the period of 2000-Dec 2015. The new patients with HBV infection, HCV infection, or non     alcoholic fatty liver disease who will undergo biopsy during the period Jan 2016- Dec 2020     will serve as a cohort for prospective design.      We will collect socio-demographic data, clinical data, family history, personal history,     medical history, anthropometry, biochemical and radiological data from each patient. We will     also be conducting a cost effective analysis for various non invasive markers against biopsy     as a gold standard in predicting fibrosis, both for retrospective and prospective cohorts.      For prospective cohort study, after evaluation of baseline biopsy results, the cases with     metavir fibrosis score (F0-3) will be followed for a period of 5 years to document incidence     of development and progression of fibrosis.      No additional investigation or test will be asked to the patient for the study. We will also     develop a predicting model for development and progression of fibrosis.   "
47890|NCT02658773|"     The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine     cream will improve pain scores compared to placebo. The investigators hypothesized that     lidocaine-Prilocaine cream will reduce the insertion pain.   "
47891|NCT02658760|"     Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia     illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine     alone on the quality of ultrasonography guided fascia iliaca compartment block in adults     undergoing femur fracture fixation surgery at 2014.   "
47892|NCT02658747|"     This is a multi-center retrospective observational research study collecting data for     participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer     (NSCLC) up to 6 years before start of data collection and who have completed/stopped     docetaxel treatment at least 30 days prior to data collection. The primary goal of this study     is to describe the percentage of participants with at least one neutropenic sepsis (NS)     episode following initiation of treatment with single-agent docetaxel. Data will be collected     until end of docetaxel treatment plus an additional 30 days to allow for presentation with     toxicity.   "
47893|NCT02658734|"     This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the     safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally     advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior     treatment with trastuzumab and a taxane.   "
47894|NCT02658721|"     Intravenous regional anesthesia (IVRA) is used in outpatient hand surgery as an easily     applicable and cost-effective technique with clinical advantages. Nevertheless, IVRA has some     disadvantages including anesthetic toxicity, slow-onset, poor muscle relaxation, tourniquet     pain, and minimal postoperative pain relief. Providing an ideal anesthesia by overcoming     these disadvantages is possible with the addition of some adjunct agents into local     anesthetic substances. One of these adjunct agents used for IVRA is tramadol, a synthetic     analgesic having opioid and nonopioid characteristics. The present study aimed to investigate     the effects of addition of systemic tramadol or adjunct tramadol to lidocaine for IVRA in     patients undergoing hand surgery..   "
47895|NCT02658708|"     This proposed study will examine feasibility and implement therapeutic bright light that is     tailored to the individual's circadian typology to estimate its therapeutic effects on     sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.   "
47897|NCT02658682|"     Depression (Major Depressive Disorder; MDD) has been dubbed the common cold among the mental     illnesses and it is also a highly recurrent disorder. Secondary prevention has been     identified as a key goal in the long-term management of depression. High recurrence rate     suggests that there are specific vulnerability factors that increase people's risk for     developing repeated episodes of the disorder. Preventive strategies should identify and     ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased     attention for emotional stimuli is central to the cognitive model where increased sensitivity     to negative cues is believed to fuel the negative thoughts and feelings in depression and     play a key role in maintaining the illness. Selective biases in attention can be modified by     a simple computerized technique; The Attention Bias Modification Task (ABM). This project     aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a     large group highly vulnerable to depressive episodes. The effects of ABM, immediately after     the two weeks intervention, on three key risk factors for depression will be studied:     Residual symptoms, cortisol awakening response and emotion regulation strategies. The     participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that     ABM will reduce subsequent episodes of low mood over the following 12 months in this group in     a manner predicted by early changes in these risk factors will be investigated. It will also     be tested if such effects in the lab may be dependent on candidate genes which affect     serotonin reuptake and which have been implicated in malleability and emotional learning.     Effects on underlying neural correlates of emotion regulation will be studied in an fMRI     experiment in a sub-sample and which will also be stratified by serotonin transporter     genotype (see also NCT02931487). The predictive value of meta cognitions related to     rumination and the possible mediating effects of automatic thoughts and perceived stress will     also be investigated in a sub group (see also NCT02648165).      The characterization of the cognitive, genetic and neural mechanisms underlying the ABM     effect will have key implications for future treatment development and combination with other     treatment modalities like pharmacotherapy.   "
47898|NCT02658669|"     Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have     suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury     symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI     patients has the potential to exacerbate other symptoms, delay recovery, and negatively     affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby     decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has     been shown to be an effective evidence-based treatment for insomnia, there are no published     randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I     in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to     provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who     have suffered mTBI.   "
47899|NCT02658656|"     Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and     quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have     completed rehabilitation after injury and are unable to ambulate receive a wheelchair as     standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently     become available as an alternate form of mobility by providing an external framework for     support and computer controlled motorized hip and knee joints to assist with over ground     ambulation.   "
47903|NCT02658604|"     RATIONALE:      Several examples in the literature describe the types of medication management issues     uncovered during the course of home-based medication reviews. For example, the investigators     previously reported the outcomes of home medication reviews of 43 homebound community     pharmacy patients, finding that 58% of patients were keeping medications in the home that     were expired, duplicates of other current medications, or no longer therapeutically     appropriate.      Many of these issues, due to their nature, could be considered to be hidden, i.e. issues     that are unlikely to be adequately detected or resolved during the course of routine     interactions between patients and pharmacists in the community pharmacy setting. Currently,     only homebound patients in Ontario are eligible to receive government-funded home medication     review services from pharmacists. This limitation in funding eligibility is problematic as it     reduces the likelihood that non-homebound patients will receive home medication reviews, even     though this population may also benefit from these services. Indeed, evidence in the     literature is not limited exclusively to homebound patients, and suggests that non-homebound     patients are also at risk from home-centered medication management issues and may also     benefit from home medication reviews.      PURPOSE:      Our study aims to characterize the prevalence and nature of hidden in the home medication     management issues in non-homebound patients. To our knowledge, this study would be the first     of its kind to focus specifically on this patient population and lend direct evidence in     support of expanding funding of home medication review services in Ontario to include     non-homebound patients.      HYPOTHESIS:      A subset of ambulatory, non-homebound patients who regularly attend community pharmacies are     affected by medication management issues that cannot be adequately identified and resolved     during the course of a typical medication review taking place within the pharmacy. These     patients would benefit from a full medication review taking place in their own homes, similar     to what is presently provided under Ontario's MedsCheck at Home program, for which only     homebound patients in Ontario are eligible.      RESEARCH QUESTIONS/OBJECTIVES:        1. What is the frequency of, and what type(s) and severity of, drug-related problems are          detected during pharmacist visits to patients' homes who would not otherwise qualify for          a MedsCheck at Home service?        2. Based on the findings from this study, which criteria would best assist community          pharmacists in identifying ambulatory patients who may stand to benefit most from a          home-based medication review?   "
47904|NCT02658591|"     The investigators hypothesized that consuming crackers enriched with faba bean fractions     (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean     starch), would reduce the blood glucose response to the meal compared to a crackers without     faba bean components and reduce food intake at a meal   "
47905|NCT02658578|"     Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of     stroke is more dramatic in low- and middle- income countries, and the scarcity of     evidence-based rehabilitation interventions represents a major challenge to global health     care. Upper limb weakness is frequent after stroke, but there is no universally accepted     treatment to effectively improve hand function in patients with moderate and severe motor     impairment. These are the patients in deepest need of rehabilitative interventions. This     project addresses this important issue, by testing effects of a novel approach. The     investigators will non-invasively stimulate peripheral nerves in order to enhance effects of     motor training aided by an electrical stimulation device in patients with moderate to severe     hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of     motor training in patients in the chronic stage after stroke.   "
47906|NCT02658565|"     Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical     staging for endometrial cancer increases operative time and surgical morbidity, but appears     to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic     approach has not been reproduced, and the investigators propose to validate their algorithm     at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary     data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the     investigators are well-suited to perform this investigation. A surgical approach that is     tailored to the patient's cancer biology is rational, supported by the recent literature, and     medically compelling since the co-morbidities of many obese, low-risk EC patients put them at     significantly increased perioperative risk for complete lymphadenectomy.   "
47907|NCT02658552|"     To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the     treatment of benign thyroid nodules   "
48163|NCT02655198|"     In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut     epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At baseline     and at the end of the study, ECG and ultrasound of the heart will be performed as part of the     safety follow up.   "
47908|NCT02658539|"     Research has shown that body composition is a key component of health and future disease     risk. Being overweight and obese is associated with a higher body fat composition, and a     greater risk of developing type II diabetes and heart disease. The location where fat is     stored in the body is becoming increasingly recognised an important predictor of risk, with     extra fat around the abdomen and waist (referred to as the android pattern of fat     distribution or 'apple' shape) thought to increase your disease risk than storing fat around     the thighs and buttocks (gynoid pattern of fat distribution or 'pear' shape). As a result,     there is significant interest in techniques to accurately monitor and detect changes in body     composition, and also physiological and lifestyle factors which influence body fat, lean     tissue mass and bone mineral density. This cross sectional human study will look at how     physiological, behavioural and genetic factors relate to total body composition in 1,196     healthy men and women aged between 18 and 70 years. Interested applicants will be invited to     attend for a single visit at the Hugh Sinclair Unit of Human Nutrition at the University of     Reading. This visit lasts around two hours and includes noninvasive measures of body     composition (bio-electrical impedance and dual energy x-ray absorptiometry), arterial     stiffness and fasting measures of metabolic health. Diet and physical activity will then be     monitored over a four day period using diet and activity diaries, and an activity monitor.     The findings from this study will contribute to the evidence base on how subject     characteristics influence body composition and inform on the design of future human studies     on body composition methodology.   "
47909|NCT02658526|"     The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and     animal studies showed a risk for treatment with anesthesia in the developmental brain.     Furthermore, stress is also an important risk factor for cognitive impairment. Therefore, the     investigators want to investigate in a clinical prospective cohort study the role anesthesia     and surgery on different cognitive parameters and self-controling mechanisms in children     under 3 years.   "
47910|NCT02658513|"     Recently published European guidance recommends the evaluation of the radiation dose to the     bone marrow in patients undergoing radioiodine therapy for thyroid cancer. The methods     described in these guidelines require serial blood samples to be taken from the patient,     followed by a sophisticated analysis to determine the radiation dose. However, radiation risk     assessments carried out locally have indicated that a relatively high radiation exposure will     be received by the operator taking the blood samples, which may prohibit this procedure being     carried out routinely.      The radiation dose to the operator will be lowered if the duration of the blood sampling     procedure were reduced. The investigators hypothesize that the use of a lancet and pipette to     collect blood from the finger tip will greatly reduce the time spent in proximity to the     patient, significantly reducing the operator exposure and allowing this procedure to be     performed routinely. The proposed method is also less invasive for the patient compared to     the intravenous sampling recommended in the guidelines. A proof-of-principal pilot project     using radioiodine diluted to the expected concentration in blood has indicated that using     very small volumes of blood (such as from a lancet) does not compromise the accuracy of the     dosimetry measurement when compared to large-volume standard blood samples.      The primary aim of this study is to investigate whether sampling a small volume of blood     using a lancet and pipette can replace standard intravenous blood samples for bone marrow     dosimetry in patients undergoing radioiodine treatment for thyroid cancer. Statistical tests     will determine whether there is a significant difference between the doses calculated using     each blood sampling method. In addition, the investigators will measure the radiation     exposure received by the operator during each procedure using Electronic Portable Dosimeters.     The results of these measurements will be used to quantify the reduction in operator     radiation exposure afforded by the new technique.   "
47912|NCT02658487|"     This phase II trial studies how well vosaroxin and cytarabine work in treating patients with     untreated acute myeloid leukemia. Drugs used in chemotherapy, such as vosaroxin and     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading.   "
47913|NCT02658474|"     The purpose of this study is to determine whether group based Acceptance and Commitment     Therapy (ACT) at a university hospital clinic is superior to treatment in a primary care     setting among patients with chronic pain.      Hypothesis:      i) A group based ACT treatment leads to less pain and greater Health Related Quality of Life     (HRQOL) in patients with chronic pain than treatment in a primary care setting.      ii) The improvement in pain and HRQOL is mediated through an increased degree of pain     willingness and involvement in activities.      iii) Improvement of pain and HRQOL after the two treatments is associated with demographic,     psychosocial and somatic characteristics.   "
47914|NCT02658461|"     This prospective, non-interventional time and motion study will evaluate the costs of     healthcare resource utilization associated with the administration of trastuzumab (Herceptin)     SC and IV formulations in HER2-positive EBC. This is a sub-study of the clinical study     MO22982 (NCT01401166/PrefHer).   "
47915|NCT02658448|"     The purpose of this study is to determine whether GTx-024 is safe and effective in the     treatment of stress urinary incontinence in postmenopausal women.   "
47916|NCT02658435|"     The study aims to provide evidence of retinal safety to support the use of tafenoquine as a     potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax)     malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be     conducted as a single masked, randomized, placebo-controlled, parallel group design. It will     assess retinal changes from baseline using spectral domain optical coherence tomography (OCT)     and fundus auto fluorescence (FAF) at Month 3 (90 days) post-dose in adult healthy volunteers     (participants). A placebo control group will be used to compare the results in the TQ group.     Interim analysis will be conducted after completing 100 out of 300 participants in TQ group     and 50 out of 150 participants in matched placebo.   "
47917|NCT02658422|"     This study is conducted to determine whether the test product (GW483100 10 mg containing     montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference     montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under     fasting conditions. This is an open-label, balanced, randomized, single dose, two-way     crossover study, enrolling 32 healthy human subjects to ensure at least 28 subjects complete     the study. Each subject enrolled will participate in two treatment periods separated by a     washout period of at least 7 days and no more than 14 days between dosing occasions. Total     duration in the study for each subject will be approximately 7 weeks from screening to the     subject's last visit.   "
47918|NCT02658409|"     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase     III Study.   "
47919|NCT02658396|"     This research study is studying a combination of targeted therapies known as GO-203-2C and     bortezomib as a possible treatment for multiple myeloma that has either progressed or not     responded to treatment.   "
48164|NCT02655185|"     The purpose of this study is to determine whether lipid levels are related with incidence of     atrial fibrillation in Patients with chronic heart failure.   "
47920|NCT02658383|"     Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many     households use traditional cookstoves to meet these energy needs, which can result in     extremely high indoor air pollution concentrations. Indoor air pollution from biomass     combustion accounts for an estimated 3.9 million premature deaths per year, representing     about 4.8% of the global disease burden. Improved stove designs have the potential to     substantially reduce indoor air pollution exposures. However, there are few randomized     intervention trials, and previous stove intervention studies have been plagued by low     improved stove adoption and sustained use, severely limiting interpretations of these     studies. This research proposes to conduct community surveys and in-depth interviews among     Honduran cookstove users to gain insight into the complex pathways surrounding barriers to     and predictors of sustained improved cookstove adoption (among the target population for the     proposed intervention). This information will be used to conduct and enhance a randomized     improved cookstove intervention among 300 Honduran families, incorporating qualitative and     quantitative measures of cookstove use and measuring pre- to post-intervention changes in     pollutant exposures and subclinical indicators of cardiovascular health.      The primary goals are twofold:        -  To incorporate community-engaged approaches throughout all aspects of the research        -  To maximize sustained stove use (thereby maximizing the health impact of the          intervention) to achieve valid exposure-response estimates.      Both objectives utilize innovative strategies to fill knowledge gaps. The research team will     build upon previous studies in Latin America that have focused on identifying and validating     appropriate field techniques for exposure and health assessments in rural areas of developing     countries.      In summary, the proposed project will provide insight regarding barriers/predictors of     sustained cookstove adoption, an issue impeding research in this field; assess the     relationship between stove use and indicators of cardiovascular health, a substantial and     quickly growing disease burden in developing countries; and result in a more comprehensive     and valid assessment of the impact of a cookstove intervention.   "
47921|NCT02658370|"     The purpose of this pilot study is to investigate feasibility and patients´ assessment using     an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console)     for patients with rheumatoid arthritis.   "
47922|NCT02658357|"     The study will be a 6-month, open-label, multiple center study in approximately 50 stable     subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety,     tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation     of two or three, 300 mg Risperidone Implants.   "
47923|NCT02658344|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee     Osteoarthritis.   "
47924|NCT02658331|"     The aim of our study is to assess the analytical and clinical performance of the FilmArray     (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in     Guinea versus conventional molecular techniques.   "
47925|NCT02658318|"     In cleft surgery there is no current general agreement on the treatment strategy of patients     with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on     the treating physician or the hospital facility. Literature regarding peri- and postoperative     complications in the target population are lacking.      The investigators aim to retrospectively review the charts of all cleft patients, both PRS     and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015.     The incidence of peri- and postoperative complications, with a specific focus on respiratory     complications, will be examined. The value of demographic, surgical and postoperative     parameters will be examined as potential risk factors for the development of complications.   "
49899|NCT02632578|"     The aims of this study are:        1. to investigate if HIV infection alters the antibody responses to influenza and        2. to assess the ability of licensed influenza vaccine to induce functional          non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.   "
47926|NCT02658305|"     Bicortical screws have been widely used for mandibular osteosynthesis during orthognathic     surgery.Transoral placement of bicortical screws is a rigid fixation method in orthognathic     surgery, which is less often used.      The aim of this study was to compare postoperative outcome of transoral versus transbuccal     bicortical screw placement during orthognathic surgery.      This study comprises an academic, retrospective, monocentric study in which the charts of     orthognathic patients operated between January 2010 and December 2012 were retrospectively     reviewed. Postoperative complications were registered. Demographic, dental and surgical     parameters are examined as potential risk factors for the occurence of postoperative     complications.   "
47927|NCT02658292|"     A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy     and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis   "
47928|NCT02658279|"     The purpose of this study is to test if the study drug called pembrolizumab could control the     growth or shrink the cancer but it could also cause side effects. Researchers hope to learn     if the study drug will shrink the cancer by half, or prevent it from growing for at least 6     months. Pembrolizumab is an antibody that targets the immune system and activates it to stop     cancer growth and/or kill cancer cells.   "
47929|NCT02658266|"     Adults with complex congenital heart disease have impaired muscle function compared both to     health controls and patients with lesions classified as simple. There is only one study     assessing the effects of resistance training in patients palliated with Fontan procedure. The     hypotheses of the present study is that home based resistance training will improve muscle     function in adults with different complex congenital hear diseases.   "
47930|NCT02658253|"     The primary objective of the study is to evaluate the safety of 3 different dosages (20µg -     50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either     with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and     Burkinabe adults.      The safety and the tolerability of the vaccine will be assessed on the rate of solicited and     unsolicited events/reactions The safety profile will included local and systemic     reactions/events as well as the biological safety, based on a clinically significant change     of the baseline value of the main biological criteria   "
47931|NCT02658240|"     This randomized, controlled, observer-blinded study clinical trial was designed to evaluate     ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular     infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.   "
47932|NCT02658214|"     Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following     indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ     cancer.   "
47962|NCT02657824|"     Left ventricular ejection fraction (LVEF) is a parameter that should be evaluated rapidly to     the patients, admitted to the emergency department with shortness of breath. The     investigators aimed to investigate correlation between LVEF and 4 different mitral valve     movements which alternate to the classical LVEF assessing methods and evaluate these methods     can be used or not in the emergency department.   "
47933|NCT02658201|"     In haematological malignancy and in immunocompromised patients, constipation is a common     symptom caused by a number of factors during treatment. In current clinical practice, an     abdominal radiograph is the first imaging investigation for constipation and non specific     abdominal pain to support or exclude the clinical suspicion. Children are more sensitive to     radiation induced adverse effects especially in the thyroid gland and bone marrow.     Immunocompromised patients are at risk of developing a second malignant neoplasm. MRI is an     alternative imaging modality without ionizing radiation. Imaging the peritoneal cavity on     abdominal MRI has always been challenging primarily because of bowel motion and a long     acquisition time for standard T1 and T2 weighted sequences. Recent development of an     ultrafast 2 dimensional FIESTA sequence developed by GE (General Electric) Healthcare based     on the balanced steady state free precession (b-SSFP) pulse sequence has several advantages:     motion insensitivity ( does not interfere with peristalsis), sharp edge definition and higher     contrast when compared with the standard SSFSE pulse sequence. FIESTA is well suited for     abdominal imaging as it produces motion- free images, allowing clear delineation of     intra-peritoneal and retroperitoneal anatomy and is capable of depicting the vascular anatomy     and lymph-adenopathy.There is a wide spectrum of diseases which could cause abdominal pain in     our study group with constipation being the most common cause but MRI could potentially     detect more serious bowel-related chemotherapy induced complications such as typhlitis,     pneumatosis coli, veno-occlusive disease, pancreatitis and intra abdominal abscess, which     would not be apparent on abdominal radiograph.   "
47934|NCT02658188|"     The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin     enacarbil) for long-term treatment of restless legs syndrome patients.   "
47935|NCT02658175|"     An Open-Label Study of Volanesorsen (IONIS 304801) Administered Subcutaneously to Patients     with Familial Chylomicronemia Syndrome (FCS)   "
47936|NCT02658162|"     Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in     patients who will be recipients of a donation after brain death (DBD) donor kidney.   "
47937|NCT02658149|"     The primary objective of this study is to examine whether there is a difference in the level     of resting pain following total hip arthroplasty with an anterior approach with use of a     psoas compartment block versus a local periarticular anesthetic infiltration   "
47938|NCT02658136|"     Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains     severely reduced post-implant. While the effect of right ventricular (RV) failure early after     pump implantation, and its effect on outcome has been extensively studied, the effects of     late RV failure on exercise capacity and quality of life (QOL) has been sparsely described.     Thus the purpose of this study is to examine RV function and the association to exercise     capacity in CF-LVAD patients.   "
47939|NCT02658123|"     Preventing complications and readmission after ostomy surgery will decrease the cost of     healthcare, improve patient safety, reduce the cost of durable medical equipment required by     ostomates, ensure continued specialized care is available, and potentially improve both short     and long-term quality of life (QOL) for patients by reducing morbidity and mortality     associated with ostomy surgery. The purpose of this study is to measure the effectiveness of     patient centered interventions/care pathways and to determine the impact on healthcare     utilization, 30-day hospital readmissions, and QOL.   "
48059|NCT02656563|"     This is a multicentre, phase II, randomized, open label study to evaluate the efficacy and     safety of monthly Radium 223 in prolonging the off treatment interval of men with localized     prostate cancer receiving intermittent androgen ablation therapy for a rising PSA     post-radiation or post-prostatectomy, who are at high risk for occult metastases.   "
47940|NCT02658110|"     The proposed study aims to determine the metabolic and appetite responses to standard     breakfast and lunch meals whilst altering the timing of whey protein supplementation.     Currently, the designs implemented in many studies mean that it is unclear whether an optimum     time for whey protein consumption exists in order to promote the greatest acute health     benefits. A number of studies have investigated the effects of whey protein when consumed as     a preload to a subsequent meal, whilst benefits have also been shown when whey protein is     ingested with a meal. The proposed study will therefore investigate strategies of whey     protein supplementation that vary in their practical applicability, using meals that reflect     regular eating behaviours throughout the population in a sample of overweight/obese     individuals.      Findings from this study may provide important information regarding the efficacy of whey     protein supplementation before, during and after a composite meal, and its effect on the     handling of a subsequent mixed-macronutrient meal.   "
47941|NCT02658097|"     This study looks at patients with advanced lung cancer. Participants in this study will be     randomized into two groups. The first group will have radiation plus a drug (pembrolizumab).     The second group will have only the drug (pembrolizumab). Tumors of participants will be     measured to see if the addition of radiation changes the growth of the tumor compared to the     drug alone.   "
47942|NCT02658084|"     The study proposes to evaluate the safety and efficacy of the combination of trastuzumab     emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.   "
47943|NCT02658071|"     Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and     their axons slowly die with visible changes at the optic nerve head (cupping). Without early     diagnosis and effective treatment or with delayed treatment decrease of visual acuity or     blindness become.      In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are found     on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material inside     the trabecular meshwork decrease aqueous humour outflow and the intraocular pression raise.     The exfoliation material is found on the surface of the lens capsule with frequent     developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP)     decrease.      Some recent study have found decreasing ocular volume variation associated to IOP fluctuation     in night after cataract surgery in normal pressure glaucoma patients. In our study we want     see if it's the same thing in pseudoexfoliation glaucoma patients.   "
47984|NCT02657538|"     The aim of this study is to validate a near-infrared light transillumination device     (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare it     with the established diagnostic methods (visual examination and bitewing radiography). The     aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.   "
47944|NCT02658058|"     Traditionally, spinal anesthesia is performed using the palpation of bony landmark to     identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has     become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade.     Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are limited to a     midline approach using a transverse median views. The parasagittal oblique view consistently     offers better ultrasound view of the neuraxis compared to the transverse median view.     However, it is still not evident whether these superior parasagittal oblique views will lead     to an easier paramedian needle insertion. In the literature, there are no studies directly     comparing the US-guided paramedian approach using the parasagittal oblique (PSO) view, the     US-guided midline approach using the transverse median view, and the conventional landmark     midline approach to perform spinal anesthesia in the elderly patients, in particular for the     teaching of novice anesthesia residents.   "
47945|NCT02658045|"     The trial shall assess the accuracy of the Oxitone® 1000 in measuring oxygen saturation, by     comparing its measurement to reference devices: non-invasive SpO2 and pulse-rate values     determined by a pulse oximeter. A total of approximately 40 subjects: 20 healthy and 20 COPD     (chronic obstructive pulmonary disease ) patients will be enrolled. These subjects will be     enrolled at the medical center pulmonary department and will be recruited from the clinic     patient base. The subjects will be represented by male and female adults who optimally cover     a range of ethnic backgrounds (skin pigmentation). All testing will be performed in singleton     and in a blinded fashion. This study will be conducted with the approval of the medical     center ethics committee.      This is a comparison open study with no subject follow-up.   "
47946|NCT02658032|"     The purpose of this study is to test the efficacy of two separate, sequential interventions     to promote tobacco cessation/reduction in individuals recently identified with lung nodules.     Each intervention will be compared to standard of care. The first intervention will be a     personalized message intervention, the second intervention will consist of a     biofeedback-based intervention.   "
47947|NCT02658019|"     This is a single-arm phase II trial of Pembrolizumab (Keytruda) in patients with advanced,     unresectable hepatocellular carcinoma. The primary objective is to assess its therapeutic     efficacy in patients with unresectable hepatocellular carcinoma (HCC). The primary endpoint     is disease-control rate (DCR) defined as the proportion of patients achieving a best overall     response of either a complete response (CR), partial response (PR) or stable disease (SD)     (that is maintained for at least 8 weeks).      Secondary endpoints include progression-free survival (PFS), overall survival (OS), objective     response rate (ORR), duration of response (DOR), and toxicity profile of Pembrolizumab. The     investigators will also evaluate the expression levels of Programmed death-ligand 1 (PD-L-1)     in tumor tissue, as well as serum titers of hepatitis B or C in patients with hepatitis B or     C, respectively, for whom specimens are available.   "
47948|NCT02658006|"     The purpose of this prospective observational cohort study is to evaluate multimodal     monitoring technologies in the perioperative care of cardiac surgical patients. Right     ventricular pressure tracings, near infrared spectroscopy (NIRS) and transthoracic     ultrasonography will be studied for their ability to detect and predict complications such as     right ventricular failure, renal failure and respiratory failure.   "
47949|NCT02657993|"     The purpose of this study is to determine whether hypnosis is efficacious in reducing     musculoskeletal pain in breast cancer survivors taking aromatase inhibitors, and by doing so,     whether hypnosis can help survivors to be more adherent to their medication regimen.   "
47950|NCT02657980|"     Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:     Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject,     Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment   "
47951|NCT02657967|"     This study is an observational study to determine predictors of sudden cardiac death or     appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be     followed for 36 months for the occurrence of sudden cardiac death   "
47952|NCT02657954|"     Cognitive impairments are present in up to 80% of homeless individuals, and may contribute to     homelessness in Operation Enduring Freedom / Operation Iraqi Freedom / Operation New Dawn     (OEF/OIF/OND) Veterans. The investigators propose to investigate these issues in homeless,     treatment-seeking returning Veterans, who arguably face multiple potential barriers to     recovery and reintegration, and with whom there is the greatest opportunity to prevent     long-term homelessness. The investigators plan to conduct a 15-week randomized controlled     trial of an evidence-based, 10-week Compensatory Cognitive Training (CCT) intervention vs. an     education control condition to examine the effects of cognitive rehabilitation in this     Veteran population. The investigators expect CCT-associated improvements in cognition and     functional skills and generalization to reduced levels of disability, along with improved     community reintegration outcomes. By attending to and treating cognitive impairments, the     investigators can potentially prevent future homelessness and its negative health     consequences, resulting in both healthcare cost savings and improved quality of life for     Veterans.   "
47953|NCT02657941|"     People with severe mental illness have an increased risk of somatic comorbidities such as     metabolic syndrome, obesity, hypertension, dyslipidemia and diabetes mellitus, which induce     an increased risk of early mortality, mainly because of cardiovascular diseases.      These high cardio-metabolic risks result of several factors such as lack of access to medical     care, a poor and unbalanced nutrition, physical inactivity and smoking but they are also     exacerbated by antipsychotic medications and anti-epileptic mood stabilizers prescribed to     treat their psychiatric disorder.      These prevention and awareness interventions in lifestyle are most often implemented in     ambulatory stabilized patients. Also weight gain occurs in the early months of treatment. The     therapeutic education program evaluated in this study seeks to potentiate the effectiveness     of these preventive measures through early awareness in hospitalized patients.      Finally, this study aims to compare the efficacy of two early and short programs on health     behavior: first a program inspired by motivational interviewing and behavioral psychotherapy     and secondly an exclusively educational program (information, formative assessment).   "
47985|NCT02657525|"     The purpose of this study is to investigate the demographic characteristics, clinical     features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease     prognosis and its economic burden.   "
47954|NCT02657928|"     This phase II trial studies how well ribociclib and letrozole work in treating patients with     estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial     cancer that has returned (come back) after a period of improvement. Ribociclib may stop the     growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are     estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen     made by the body and this may stop the growth of tumor cells that need estrogen to grow.     Giving ribociclib together with letrozole may be an effective treatment in patients with     ovarian, fallopian tube, primary peritoneal, or endometrial cancer.   "
47955|NCT02657915|"     The primary objective of the study is to assess full-field visual evoked potential (FF-VEP)     latency in subjects who were enrolled in Study 215ON201 (NCT01721161) 2 years (+ 4 months)     after the last study visit. The secondary objective is to assess clinical progression and     severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled     in Study 215ON201 2 years (+ 4 months) after the last study visit. No study drug dosing is     planned for this study.   "
47956|NCT02657902|"     The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is     associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric     fractures.   "
47957|NCT02657889|"     This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with     niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative     breast cancer or recurrent ovarian cancer. (KEYNOTE-162)   "
47958|NCT02657876|"     This study is designed as a prospective, multicenter, open-label trial focused on assessing     the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic     foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care     comparator is not included in this first-in-human study. Targeted enrollment for this study     is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects     will each receive a single application of ExpressGraft-C9T1 skin tissue on a single     identified study DFU following a 6-10 day run-in period. Any subjects requiring additional     treatment will receive protocol-defined dressings through study session 7 as necessary.     Enrollment will occur with a minimum of one week between each subject.   "
47959|NCT02657863|"     This study is being conducted to collect and analyze biospecimens (blood and urine) and     clinical data from patients with prostate cancer as well as healthy volunteers to better     understand the differences between cancer cells and normal tissues with the goal of     developing a better way to detect and track the treatment of prostate cancer.        -  These samples are being collected to conduct research to accomplish the goal of          improving cancer therapies, biomarkers, and hopefully lead to more effective treatment          of prostate cancer.        -  The samples that you are providing as a patient with prostate cancer will be used in          future research.        -  Your biospecimens will be compared to the cancer and normal volunteer specimens from          other participants to understand genetic differences between normal and cancer cells.          Genetic material, including DNA and RNA, will be obtained from samples, stored, and used          for evaluation.        -  Clinical information and samples will be collected and stored for ongoing research. This          is a necessity because improved diagnosis, prognosis and treatment of cancer in the          future depend upon the ongoing analysis of basic research findings and clinical          outcomes. This type of research may improve the lives of future patients with cancer.      Men between the ages of 18 and 100 with a diagnosis of cancer undergoing standard therapy     with radiation may join.   "
47969|NCT02657733|"     Respiration rate is a critical vital sign that provides early detection of respiratory     compromise and patient distress. Continuous monitoring of respiration rate is performed in     patients under different clinical conditions, including post-surgery or different respiratory     diseases. Clinician observation, pulse oximetry, and capnography are used individually or in     combination to monitor ventilation during sedation and on post-surgical patients. The     American Society of Anesthesiologists mandates the monitoring of respiration by measuring end     tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques     for respiration rate measurement include different technologies such as acoustic respiratory     rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain     respiratory conditions.   "
47960|NCT02657850|"     Cancers located in the upper aerodigestive tract of the head and neck region present unique     management challenges due to the crucial functions in this anatomic region along with its     anatomic density. As such, cancers themselves and the actual treatment can affect these     functions. Of these, the ability to effectively and safely transport a swallow bolus from the     oral cavity to the esophagus is particularly important. This consideration has in fact been a     major source of debate regarding the optimal management for head and neck cancers as both     oncologic-effective and function-preserving therapies are desired. Accomplishing this     therapeutic goal has been elusive and can be attributed to a lack of tools that effectively     and longitudinally evaluate swallow function over the course of a treatment and in follow-up.     As such, investigators surprisingly lack a clear understanding of the natural history of     treatment -related swallow dysfunction (dysphagia) regardless of the treatment modality. As     such, understanding the prevalence of this significant complication is in fact not well     established. Understanding the true prevalence of treatment-related dysphagia is in fact     critical to establish as it will help guide decisions as to whether or not treatment     strategies require modification including de-intensification of treatment that is receiving     considerable attention for favourable prognosis patients associated with the human     papillomavirus (HPV).      To address this problem, winvestigators hypothesize that the quantitative and validated     patient-reported outcome (PRO) instrument, the Sydney Swallow Questionnaire (SSQ), can be an     effective tool to longitudinally measure swallow function to determine the natural history of     head and neck cancer treatment-related swallow dysphagia. The SSQ is particularly well suited     for longitudinal evaluation of swallow function as it quantifies various aspect of     patient-perceived swallow function in contrast to other swallow PROs that measure the impact     of swallow function on quality of life domains. To determine the two-year prevalence of     dysphagia, investigators will employ a multi-institution prospective study design using our     Oncospace® web-portal to facilitate secure prospective data curation and analysis that will     include evaluations before, during and following standard of care definitive cancer treatment     for a total of 36 months in the follow-up period.   "
47961|NCT02657837|"     The Lung Clearance Index, measured by multiple breath washout, is a measure of lung function     that is considered a research tool in Canada as the device used to measure it is not approved     by Health Canada. The study will assess lung function in patients undergoing routine lung     function testing for clinical indications (Cystic Fibrosis and Other Respiratory Diseases).     In addition, healthy controls of different ages will be asked to perform this lung function     test to gain reference data that can be used to interpret LCI in patients with lung disease.   "
48008|NCT02657226|"     This study aims to examine the association between intensive monitoring of renal function     (urine output, serum creatinine, and both) and outcomes among critically ill patients with     and without Acute Kidney Injury (AKI)   "
47963|NCT02657811|"     Embryo culture and selection has been a continuous challenge in evolution since the birth of     In Vitro Fertilization (IVF). Traditionally, embryo quality and its presumed suitability for     transfer were assessed based on morphologic features. However, the consensus as to the     optimal time points for embryo assessment and as to 'preferable' characteristics have been     challenging. Alongside this has been the challenge of achieving balance between multiple     points of assessment, yet stabilizing the embryo environment for growth. In standard     incubation, each new morphological assessment of embryos in culture theoretically creates an     additional disruption to culture.      Most recently, time-lapse incubators (TLI) have been introduced as a novel embryo culture     system attempting to limit culture disturbances. These incubators have been integrated with     digital imaging, allowing for a substantial limitation in embryo handling and environmental     disturbances. They have also introduced new morphokinetic parameters to embryo assessment and     to optimizing selection of embryos. Thus far, a limited number of studies have examined the     clinical outcomes and value of time lapse monitoring systems versus the more ubiquitous     incubators (e.g. multichamber) for reproductive outcomes. In particular, the isolated value     of morphokinetics in embryo assessment and of this new stable culture environment in TLI are     still in question.      The objectives of this study are to prospectively assess and compare fertility outcomes when     embryos are cultured in the TLI system versus more traditional bench incubators (BI). We will     specifically assess the added value of the closed and isolated TLI compared to BI on     reproductive outcomes, as well as the value of morphokinetic grading in IVF.   "
47964|NCT02657798|"     This study will investigate the biological pathways involved in anti-depressant resistance     that increase risk of cardiovascular disease in people with depression.   "
47965|NCT02657785|"     This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high     effective in primary central nervous system lymphoma (PCNSL) patients.   "
47966|NCT02657772|"     The purpose of this study is to assess the safety and efficacy rates of the treatment of     small intracranial aneurysms with Stryker Neurovascular's Target® 360 Ultra coils which are a     type of platinum coils used to occlude aneurysms.   "
47967|NCT02657759|"     This research aims to evaluate the effect of CARDICHOL chronic consumption (12 weeks) on     lipid metabolism and especially on blood LDL cholesterol in volunteers with moderate     hypercholesterolemia.   "
47968|NCT02657746|"     Background: High blood pressure (BP) is the leading attributable risk for cardiovascular     disease (CVD). In rural South Asia, hypertension remains to be a significant public health     issue with sub-optimal rates of case finding and management. The goal of the full-scale study     is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care     strategies on lowering blood pressure among adults with hypertension in rural communities in     Bangladesh, Pakistan, and Sri Lanka.      Methods/Design: The mixed-methods, stratified cluster randomized controlled trial      Intervention: The multi-component interventions (MCI) is comprised of all the following five     components: 1) home health education (HHE) by government community health workers (CHWs),     plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general     practitioner (GP) using a checklist, plus 3) training public and private providers in     management of hypertension and using a checklist, plus 4) designating hypertension triage     counter and hypertension care coordinators in government clinics, plus 5) a financing model     to compensate for additional health services and provide subsides to low income individuals     with poorly controlled hypertension.      Usual care: Will comprise existing services in the community without any additional training.      Participants: The trial will be conducted on 2550 individuals aged 40 years or older with     hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive     therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550     individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg)     will be selected, 14 from each community, to investigate the effect of MCI on results from     ambulatory BP monitoring.      Qualitative component: Stakeholders including policymakers, district managers, and community     health workers, GPs, hypertensive individuals and family members in the identified clusters     will be surveyed.      Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24     months post randomization. The cost effectiveness outcome is the incremental cost of MCI per     unit reduction in BP over the two year time period and in terms of incremental cost per CVD     DALYs averted.   "
47996|NCT02657382|"     The purpose of this study is to evaluate the blood flow to the heart during stress and assess     changes in blood flow after psychological treatment in participants with coronary artery     disease. The aims of the study are to assess the effects of heart rate variability (HRV)     biofeedback (versus usual care) on global and regional myocardial blood flow (MBF),     peripheral vascular function, and autonomic changes during mental stress.   "
49900|NCT02632565|"     In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and     saline injection on pain, stiffness and physical function in patients with osteoarthritis.   "
47970|NCT02657720|"     Respiration rate is a critical vital sign that provides early detection of respiratory     compromise and patient distress. Continuous monitoring of respiration rate is performed in     patients under different clinical conditions, including post-surgery or different respiratory     diseases. Clinician observation, pulse oximetry, and capnography are used individually or in     combination to monitor ventilation during sedation and on post-surgical patients. The     American Society of Anesthesiologists mandates the monitoring of respiration by measuring end     tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques     for respiration rate measurement include different technologies such as acoustic respiratory     rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain     respiratory conditions.   "
47971|NCT02657707|"     A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and     effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with     the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in     patients with elevated risk for adverse events following carotid endarterectomy.   "
47972|NCT02657694|"     REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is     observing and collating the treatment course, safety profile, and outcomes of patients around     the world who are choosing to self import generic versions of the Direct Acting Antivirals     Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.   "
47973|NCT02657681|"     This is a randomized sham-controlled double-blind study to test the hypothesis that     transcranial static magnetic field stimulation (tSMS) of the motor cortex improves     levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will     receive real tSMS treatment, the other half will receive sham treatment (placebo).   "
48051|NCT02656667|"     The aim of this study is to evaluate the effectiveness of quadriceps strengthening with     neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary     rehabilitation program , in patients with severe or very severe COPD , according to GOLD with     BODE index ≥ 5 .   "
47974|NCT02657668|"     The study was quasi-experimental including patients in two intervention and control groups.     Three measurements were done: pretest, post-test, and a two-months follow-up. The study     population included patients with irritable bowel syndrome(diagnosed by specialists and based     on the criteria of Rome III), who referred to a general Hospital. Fifty two irritable bowel     syndrome patients were selected and assigned to two experiment (26 cases) and control (26     cases) groups. The criteria below were considered in selection of patients.      Inclusion criteria: 1) Patients should not have participated in other psychological     interventions concurrently; 2) Participants had not reported diagnosis of non-functional     gastrointestinal illnesses. 3) Women patients had not been in pregnancy; 4) Participants had     not met diagnosis of schizophrenia and bipolar disorders.      Exclusion criteria: Three or more absences in the group sessions Co-variate variables: 1)     demo-graphical variables (age, birth order, and education); 2) clinical variables (global     psychological status, mind-body attribution, and duration of disease).   "
47975|NCT02657655|"     Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim     of this study is to investigate the impact, validation, and usability of the Kinesia 360     system.   "
47976|NCT02657642|"     Background : The transitional care OMAGE-P combines three best practices recommendations from     the French National Authority for Health (HAS) (i) a comprehensive review of diagnosis and     treatments (ii) a standardized medical report and (iii)a patient education program     specifically designed for older people with multiple chronic conditions and polypharmacy.     This transitional care is implemented in a pilot general hospital with the support of French     ministry of Health and Regional Agency for Health of Ile de France . The aim of the study is     to assess the impact of the OMAGE P transitional care on the readmissions of non demented     older people aged 75 years and over within the 3 months following their discharge to home and     its cost-effectiveness .      Study Population: non demented people aged 75 years and over admitted in emergency (ie via an     emergency department ) in the participating units      Study design:      Observational prospective monocentric non randomized comparative study Exposed patients:     eligible patients admitted in participating units and who does not oppose to the collection     of his personal data. The hospital physician in charge will conduct the comprehensive review     of diagnosis and treatments and will do the standardized medical report. Patient education     program will be conduct by the hospital physician and the OMAGE nurse during the     hospitalization (two sequences) and during 2 to 4 home visits in the month following patient     's discharge from hospital.      Non exposed patients: eligible patients from the usual care arm of the RCT OMAGE. To ensure     that risk for emergency readmissions is not different between exposed and non exposed , the     rate of emergency readmissions of non exposed group will be compared with the one of eligible     patient admitted in the participating units in 2013 and 2014.      Setting: General hospital of Eaubonne : geriatric department (acute geriatric unit,     rehabilitation unit , geriatric mobile unit ) and internal medicine department Number of     subjects to be included: 484 (242 in each arm). The data for the 242 non exposed patients are     still available, 242 patients has to be included in the exposed group   "
47977|NCT02657629|"     The purpose of the study is to determine if a continuous feeding regimen as compared to an     intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic     left heart syndrome (HLHS) after stage 1 procedures.   "
47978|NCT02657616|"     The central questions of the study can be summarized as follows:      What stroke / death rates are the result of the use of the following treatment strategies: no     anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs),     anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic     complication rates resulting from the use of these treatment strategies? What heavy bleeding     rates resulting from the defined management strategies? The analysis is based on a data set     of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the     reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation     time per patient is 12 months.      Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.      The aim of the study is to compare clinical outcomes between the different treatment     strategies (frequency of events and time to first event). The influence of alternative     treatment strategies is measured on the basis of three different methodological approaches:     unadjusted comparison of event council and time to first event between the defined patient     groups; matched-pair comparison (propensity score matching) between the different groups of     patients (treatment strategies) and multivariate analysis using time to event (Cox     proportional hazards model) as the dependent variable.   "
47997|NCT02657369|"     The primary purpose of the study is to evaluate objective response rate ([ORR]: complete     response [CR] and partial response [PR]) by investigator review in participants with     anaplastic thyroid cancer (ATC) treated with lenvatinib.   "
47998|NCT02657356|"     This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in     patients with connective tissue disease-associated pulmonary arterial hypertension to     determine the recommended dose range and evaluate the change from baseline in 6-minute walk     distance (6MWD) following 24 weeks of study participation.   "
47979|NCT02657603|"     This is a single center, randomized, blinded trial in healthy volunteers. The volunteers will     receive bilateral placement of the new catheter corresponding to the adductor canal. Each     volunteer will have a catheter placed in the adductor canal in both legs. The catheters are     randomized to be placed either in the long-axis or short-axis plane of the adductor canal.     Both catheters will be injected with local analgesics (LA). Allocation will be blinded to the     volunteer and the investigator assessing sensory function. The volunteers will be sent home     with the catheter in situ and return the following day. Injection with LA is repeated and     sensory function is tested again. Furthermore catheter position is determined with ultrasound     during injection. If sensory function is not affected by injection of LA then the catheter is     visualized with ultrasound and repositioned followed by a second injection of LA and     subsequent assessment of sensory function   "
47980|NCT02657590|"     This study aims at recording cardiac arrhythmias in patients after open heart surgery. The     arrhythmias will be monitored during the entire first postoperative period, till six weeks     after surgery.   "
47981|NCT02657577|"     WIC is a governmental program that provides healthy foods, nutrition education and referrals     to other health and social services. With the goal of applying for a future grant to expand     the dissemination of SmartLoss® within the WIC program, feedback (via focus groups) from the     WIC employees and WIC recipients must be solicited to better understand the burden and     barriers of integrating these kinds of programs and with WIC participants.   "
47982|NCT02657564|"     This study evaluates the changes of renal function after taking bowel cleansing agent     polyethylene glycol for elective colonoscopy.   "
47983|NCT02657551|"     This research study is studying a targeted therapy as a possible treatment for thyroid     cancer. A targeted therapy is a type of treatment that uses drugs or other substances to     identify and attack specific types of cancer cells with less harm to normal cells.      - The name of the study intervention involved in this study is regorafenib.   "
47986|NCT02657512|"     Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X.     Bleeding events related to rivaroxaban are the consequence of physiopathologic,     pharmacokinetic issues or poisoning. Few results are available on the use of activated     charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that     activated charcoal can reduce significantly exposition to apixaban (a direct oral     anticoagulant of the same class). The objective of this study is to evaluate the effect of     activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial     with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four     treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated     charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.   "
47987|NCT02657499|"     This innovative study will measure the impact of Affordable Care Act-sponsored Medicaid     expansions on access to and utilization of community health center (CHC) services. Building     on the investigators prior work that developed a robust community-based research     infrastructure within the OCHIN community health information network, the investigator will     utilize linked electronic health record data from the OCHIN network of >400 CHC clinics in 8     states that expanded Medicaid coverage and 8 states that did not expand.   "
47988|NCT02657486|"     The purpose of this study is to study the activity and effects of BGJ398 on bladder cancer     tumors that are confined to the lining of the bladder.   "
47989|NCT02657473|"     The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS)     once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint     is a reduction of exacerbations of the disease during the treatment period. Next to this     parameter the investigators expect to show a significant beneficial effect on lung function     parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.   "
47990|NCT02657460|"     The study is to investigate the anticancer effect and the related immunological mechanism of     MTX-ATMPs in the treatment of malignant pleural effusion.   "
47991|NCT02657447|"     This study is a phase I, open label, randomized study to assess pharmacokinetics,     biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan     (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study     will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.   "
47992|NCT02657434|"     This is a randomized, Phase III, multicenter, open-label study designed to evaluate the     safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed     compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are     chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be     randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin +     Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in     two phases: Induction Phase and Maintenance Phase.   "
47993|NCT02657421|"     The purpose of this single-arm observational study is to observe and document clinical     outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc     disease or degenerative scoliosis, and report the rate of adverse events of interest through     the 24 months follow-up visit.   "
47994|NCT02657408|"     The primary and secondary objectives of the current study are the assessments of     anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory     response after 4 weeks treatment with BI 1026706.   "
47995|NCT02657395|"     Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental     root coverage procedures.   "
47999|NCT02657343|"     Participants that have breast cancer that has spread to other parts of the body, is positive     for a protein called HER2, and has not responded to standard treatment. This research study     is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a     possible treatment for this diagnosis.   "
48001|NCT02657317|"     This is a research study of an interdisciplinary pain management program for U.S. military     veterans who served during the post-9/11 combat eras (e.g., Operations Iraqi Freedom [OIF],     Enduring Freedom [OEF], New Dawn [OND]) presenting with chronic musculoskeletal pain related     to military service with comorbid depression and/or posttraumatic stress disorder [PTSD]     symptoms and/or mild traumatic brain injury. This study will test the efficacy of an     interdisciplinary pain program compared to treatment as usual in the Veterans Health     Administration on pain-related disability, opioid medication use, and pain coping.   "
48002|NCT02657304|"     Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed.     SA can increase the occurrence of cardiovascular, endocrine and metabolic events     (particularly stroke, diabetes & obesity). CPAP is currently the Gold Standard treatment of     SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is     a significant problem where a significant rate of rejection and abundance after 6 months of     treatment.   "
48003|NCT02657291|"     Patients for upper limb surgeries who are candidates for infraclavicular block will be     screened. Two techniques of infraclavicular block will be compared. Measured outcomes are     performance times, block onset times, patient satisfaction, quality of block, and requirement     for supplementary analgesia.   "
48004|NCT02657278|"     Aim: To determine whether the lactate threshold during CPET is influenced by the presence of     haemodynamically significant PAD.      Assumption: Correction of haemodynamically significant PAD results in an increased LT,     measured by CPET.      Design: Prospective study Population: Thirty patients scheduled to undergo surgical or     percutaneous treatment of iliofemoral arterial disease for intermittent claudication.   "
48005|NCT02657265|"     This study will compare two standard treatments in acute stable traumatic vertebral fractures     (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:        1. SpineJack® system        2. Conservative Orthopedic Management consisting of brace and pain medication.   "
48006|NCT02657252|"     It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%     hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only     adult women with reticular veins on the side of the thighs and mild venous insufficiency     (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.   "
48007|NCT02657239|"     MOVE UP is a weight management program for adults 60-75 in community settings led by trained     community health workers.   "
48009|NCT02657213|"     The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with     MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison     sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1     diabetic adults with an increased risk of hypoglycemia.      The study should show:        -  A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a          reduction in the time spent in hypoglycemia six months in any group compared to          Baseline.        -  A complete prevention of severe and not severe hypoglycemia in the pump group Minimed          640G + Enlite sensor with SmartGuard activation   "
48010|NCT02657200|"     KAP-study in Flemish midwives with intramural employment   "
48011|NCT02657187|"     Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis     of the affected skeletal muscles. There have been several studies reported positive     relationship between muscle mass and amount of neuromuscular junction. The purpose of this     study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle     mass.   "
48012|NCT02657174|"     The association between low level laser and auricular acupuncture can be an alternative when     conventional drugs are contraindicated or to reduce the quantity of these postoperative     medications. The objective of this study is to evaluate the efficiency of low level laser at     auriculotherapy points in reducing postoperative pain in lower third molar surgery. Eighty     third molars surgeries will be performed in 40 healthy patients by a split-mouth design.     Immediately after surgery, each side of the patient's mouth will be randomly treated with     different regimens in a double-blind design: low level laser in auricular acupuncture points     or simulation of its use. This treatment will be performed at 24 and 48 hours after surgery.     The primary variable is the post-operative pain. The secondary variables are trismus, edema     and local temperature. They will be assessed at baseline, 24 hours, 48 hours and seven days     after surgery.The blood samples for analysis of systemic inflammatory cytokines (TNF-α,     interleukin 1, interleukin 6 and interleukin 8) will be assessed at baseline and 24 hours     after surgery.   "
48013|NCT02657161|"     Phase I clinical study for an investigational PIKA (Polyinosinic-Polycytidylic Acid Based     Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA     adjuvant. The primary objective of the study was to assess the clinical safety of the vaccine     composition in healthy adult volunteers. The secondary objective was to evaluate the     vaccine's efficacy based on an accelerated vaccine regimen.   "
48014|NCT02657148|"     The investigators have designed a single site, Phase IV open label, prospective observational     clinical trial to compare the effect of immediate postpartum Nexplanon placement (IPP) versus     standard postpartum contraceptive care (control) on consistent contraceptive use and rapid     repeat pregnancy at 12 months postpartum in 200 opioid dependent (OD) women.   "
48015|NCT02657135|"     TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a     research study that brings together TBI patients, advanced evaluation methods, and experts in     a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects     self-help strategies might have on TBI outcomes.   "
48016|NCT02657122|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     single ascending doses and multiple ascending doses of the investigational drug TD-1473     compared to placebo in healthy subjects.   "
48141|NCT02655484|"     The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects     or patients with COPD ventilated during exercise assisted by the single-limb circuit with a     plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level     of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for     predicting CO2 rebreathing.   "
48017|NCT02657109|"     4 consecutive days with volunteers between the first and fourth postoperative period of     cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group     submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the     study, which consists of respiratory and metabolic exercises. The second group, called Early     Mobilization Group in addition to the aforementioned exercises will be added exercise in     cycle ergometer. For the implementation of rehabilitation protocol in the early mobilization     group volunteers will be placed in a sitting position in the bed with the backrest raised to     45 °. The exercise in cycle ergometer will be held for 20 minutes on four consecutive days of     active mode, the training load shall be such that the voluntary maintained throughout     training a level of fatigue, maintaining level of heart rate predicted for age increased by     70% and 1 w / cm2 every minute to keep the parameter within the standards. The evaluation of     heart rate variability with the Polar monitor RS800CX brand model before surgery was     performed first postoperative day and fifth postoperative day in the control groups and early     mobilization.   "
48018|NCT02657096|"     In light of the controversy that are already approved but that however still exists regarding     the efficacy and influence of the decontaminant tools for the management of Chronic     Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the     post-treatment clinical parameters and immunological and gingival microbial profiles in     patients with CP, treated by either SRP in addition to desiccant or SRP alone.      The null hypothesis to invalidate was that, after a one year follow-up, there were no     variations, in relation to clinical, anti-microbial and anti-inflammatory parameters between     SRP + desiccant and SRP alone treatment.   "
48019|NCT02657083|"     The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the     standard treatment without computer algorithm decisions - SAP therapy in 20 children and     adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity.      The aims of the study are:        -  to demonstrate that the use of DreaMed MD-AID is safe during physical activity        -  to investigate the risk of hypoglycemia among children and adolescents with T1D after          afternoon exercise during closed-loop control.   "
48020|NCT02657070|"     The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a     novel rehabilitation method that augments visuomotor feedback of movements of the patient in     virtual reality, is effective in treating hemiparesis resp. learned non-use.   "
48021|NCT02657057|"     The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS)     is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for     subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.   "
48022|NCT02657044|"     Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal     cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique     for resection of large distal colorectal adenomas, however, maintains some important     limitations. In large lesions, EMR can often only be performed in a piecemeal fashion     resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic     submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer     procedural time, but is promising due to the high en-bloc resection rates and the very low     recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with     regard to recurrence rates and radical (R0) resection rates, and to put this into perspective     against the costs and complication rates of both strategies and the burden perceived by     patients on the long term-term.   "
48023|NCT02657031|"     This study compares the efficacy of low dose Ketamine versus Compazine for the control of     headache in patients presenting to the Emergency Department.   "
48024|NCT02657018|"     The purpose of this study is to investigate if MOBIGAME (an innovative, mobile phone-based     game application) is suitable to increase daily physical activity and physical activity     adherence as well as health parameters such as cardiorespiratory fitness, leg strength,     glucose metabolism, vascular health and self-determination as well as health related quality     of life in the course of a 24-week intervention in comparison to the control group receiving     one-time lifestyle counseling.   "
48025|NCT02657005|"     Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets     family transcription factors driving tumor progression. TK216 is designed to inhibit this     effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. This study is a     first in human study of TK216 in subjects with Ewing sarcoma. The study is designed to     establish initial safety and efficacy data to assess the potential of TK216 for further     development.   "
48026|NCT02656992|"     Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose     of this study is to evaluate the effects of high-intensity inspiratory muscle training     (High-IMT) and sham High-IMT (control) on exercise capacity, respiratory muscle function     (strength and endurance) and health related quality of life in patients with bronchiectasis.   "
48027|NCT02656979|"     The main purpose of this project is to investigate the blood flow of the ophthalmic artery     (OA) in patients with ocular hypertension, high tension glaucoma and normal tension glaucoma.     It is also to study the influence of the intraocular pressure difference on OA blood flow in     the two first groups. Furthermore, the investigators want to understand the relationship     between ocular dynamics, blood flow and structural alternations of the optic nerve head     (ONH). The rationale behind the study is to improve knowledge of the pathogenesis of     glaucoma.   "
48028|NCT02656966|"     In this prospective nonrandomized study the investigators are going to investigate whether     auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative     anxiety.      Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to     receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not     wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI)     questionnaire) and will form the control group. The preoperative anxiety using STAI, as well     as the duration and quality of sleep on the night before surgery, the incidence of side     effects, blood pressure and heart rate will be the outcome measures in this study.   "
48142|NCT02655471|"     This is a pilot study of intervention in a group of patients with tropical spastic     paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus     zidovudine in this group of patients.   "
48029|NCT02656953|"     The aim of this study is to investigate the impact of wearing visual display units (VDU)     lenses versus progressive lenses on musculoskeletal and visual complaints in VDU workers with     work related neck complaints. This will be evaluated by means of questionnaires (Neck     Disability Index and Visual Fatigue Questionnaire), muscle tone, elasticity and stiffness,     pressure pain threshold and 2D video analysis of head posture during a VDU task.   "
48030|NCT02656940|"     The purpose of this study is to determine whether the modulation of dietary lipids are     effective in the treatment of obesity and comorbidities.   "
48031|NCT02656927|"     The purpose of this randomized controlled study is to evaluate psychological variables,     mindfulness, and pain in the context of a specialized yoga program for individuals with SCI.     Participants will be randomized to either a wait-list control condition or to a specialized     yoga program condition.   "
48032|NCT02656914|"     The purpose of this study is to evaluate the non inferiority of the clinical efficacy of the     drug associations in the treatment of flu symptoms   "
48033|NCT02656901|"     This study is designed to test the hypothesis that closed loop system reduces post operative     cognitive dysfunction incidence 15 min after anesthesia more than desflurane, sevorane, total     intravenous anesthesia manually guided by bispectral index in urologic surgical patients.      The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs     younger surgical patients.   "
48034|NCT02656888|"     The purpose of this study is to evaluate the non inferiority of the clinical efficacy of the     drug associations in the treatment of flu symptoms.   "
48035|NCT02656875|"     Patients with moderate to severe pain caused by medical conditions or surgery, who require IV     opioid therapy may be enrolled in this open label safety study. Patients will be treated with     TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined     by the investigator, for a duration not to exceed 14 days.   "
48065|NCT02656485|"     This is a single center, randomized, double-blind, placebo-controlled study in subjects with     acne vulgaris.   "
48066|NCT02656472|"     The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolyntic     drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing     pediatric cardiac surgery.   "
48092|NCT02656134|"     Background and study aim The relative risks of duodenal adenocarcinoma and ampullary     carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher     than in general population. However risk factors, including a genotype-phenotype association     for duodenal cancer in FAP has not been fully understood. The aim of this study is to     determine risk factors associated with the development of advanced duodenal polyposis and     ampullary adenomas in colectomized patients with FAP.   "
48036|NCT02656862|"     Fever is one of the main reasons for outpatient consultations in sub-saharan Africa.     Following the introduction of malaria RDTs, clinicians face a high number of malaria-negative     patients for whom they do not have a clear diagnosis. Through clinical history and     examination, acute fever patients are categorized into: acute respiratory infections, urinary     tract infections and other focal infections, diarrheal fevers and undifferentiated fevers.     The latter being patients where no focal source of infections can be found during the     consultation visit. In this proposal, the investigators focus on these acute undifferentiated     fevers in an outpatient clinic.      These fevers have the challenge of few point-of-care tests (POCT) available for the     clinicians to identify the etiology of fever and guide treatment in resource-limited     countries. As a consequence, over-prescription of antibiotics has increased. In order to     improve patient outcomes while supporting judicious use of antimicrobials, there is an urgent     need to change the management of febrile patients in low-income countries. This can only be     achieved by providing evidence-based clinical guidelines for the management of these acute     febrile patients. To develop such guidelines, epidemiological data on etiologies of     undifferentiated fever need to be generated. The investigators will evaluate pathogen     infection (such as dengue, chikungunya and others) in 640 patients ≥ 2 years old with acute     undifferentiated fever. To evaluate the existence of aspecific and subclinical infections and     co-infections, the investigators will also test a subsample of 200 patients with ARI, UTI,     diarrheal fever and malaria. The investigators expect to have as main results: proportions of     each syndrome among fever patients, key pathogens associated with undifferentiated fever and     their clinical presentation and demographic characteristics.   "
48037|NCT02656849|"     This research study is studying whether a new experimental cancer study drug BAY 1000394 will     be helpful in treating solid tumor cancer with an abnormality in one of the following genes:     Mcl-1, Myc or CCNE.   "
48038|NCT02656836|"     The overall objective of the study is to scope the self-management for self-monitoring     glaucoma using home tonometry.   "
48039|NCT02656823|"     Multicenter study to assess the survival and the success rates of six short implants (ANKYLOS     C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in     function.   "
48040|NCT02656810|"     The purpose of this study is to compare the pharmacokinetics (blood levels) of two     teriparatide products, PF708 and Forteo, in healthy subjects.   "
48041|NCT02656797|"     Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment     for cutaneous leishmaniasis of Leishmania species major and tropica.   "
48042|NCT02656784|"     This is a sample made up of ninety-six adult individuals of both sexes to be divided into     three groups: the experimental group of thirty-two patients with OCD who will be undergone     Trial-Based Cognitive Therapy; the gold standard, with thirty-two people with OCD subject     Exposure and Response Prevention and the control group of thirty-two healthy individuals.     Interviews and therapeutic intervention occur in private practices researchers or medical     schools accredited by UESPI.      Experimental group: Will be eligible adults of both sexes with educational level equal to or     higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed     according to criteria DSM-IV (APA, 1994). It is going to be excluded patients who had     previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.   "
48043|NCT02656771|"     The purpose of this study is to measure quantitatively the implant stability and implant     related remodeling of the periprosthetic femoral bone of the new uncemented Echo® Bi-Metric®     Full proximal Profile total hip arthroplasty (THA) stem, and compare it to the classical     uncemented Bi-Metric® Porous Primary THA stem by measuring migration of the stem assessed by     model-based radiosteriometric analysis (MB-RSA) and measuring the periprosthetic adaptive     bone remodeling assessed by dual-energy x-ray absorptiometry (DXA).   "
48044|NCT02656758|"     The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The     attention deficit hyperactivity disorder families had received executive function training     one year before.They will be randomized to intervention group and control group using a block     randomization design. The intervention group will participate in intensive executive function     training immediately,while the control group will receive executive training after 3 months.   "
48045|NCT02656745|"     The Sponsor is doing a research study to assess the effects of a smartphone program designed     to help users smoke less and eventually quit. When participants join, their involvement in     the core study will last 8 weeks. After 8 weeks, they will have the option to continue using     the program to guide their quit journey or participate in follow-up research.   "
48046|NCT02656732|"     The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20     to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly     assigned into two equal groups; control group; the coronally advanced flap with the     subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap     with amnion chorion allograft membrane (CAF+AC).   "
48048|NCT02656706|"     Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma.     High dose interferon is a standard of care in the adjuvant setting but is highly toxic and     marginally effective. The combination of ipilimumab and nivolumab is the most active regimen     in patients with advanced melanoma so there is clear rationale to test this regimen in the     adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg     ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be     six months.   "
48049|NCT02656693|"     The goal of this project is to adapt an evidence-based online weight management program and     integrate it with population management support from primary care practices. Investigators     then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1)     the combined intervention (online weight management program plus population management     support) with 2) the stand-alone online weight management program and with 3) usual care,     among overweight and obese primary care patients with type 2 diabetes or hypertension. The     specific aims are:        1. a. To adapt an online weight management program and integrate it with population          management support, incorporating input from patients, primary care clinicians, and          other stakeholders; afterward, investigators will acquire feedback on the positive and          negative aspects of the intervention.           b. To compare the effectiveness of the combined intervention (online weight management          program plus population management support) with the stand-alone online program and with          usual care.           Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months          compared with the stand-alone online program and with usual care.        2. To identify mediators of the combined intervention and the stand-alone online program.           Hypothesis 2: The effects of the combined intervention and the stand-alone online          program on weight loss will be mediated by patients' level of engagement, changes in          self-efficacy, and changes in diet and physical activity.        3. To explore whether the effectiveness of the combined intervention and the stand-alone          weight management program varies by patient characteristics.      Hypothesis 3: The interventions will be more effective among patients who are younger, white,     and higher socioeconomic status, although the population management strategy may help to     reduce these differences.   "
48050|NCT02656680|"     In a pilot randomized trial of 160 obese participants, investigators will test the     feasibility of a behavioral weight loss program delivered entirely via Facebook. Participants     will be randomized to a condition in which they will be able to invite their friends, or a     condition with study participants only. All participants will receive behavioral counseling     via the private Facebook group from the coaches who are present on the network daily.     Participants will track their diet and exercise via a free commercial mobile app.   "
48052|NCT02656654|"     Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is     essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and     prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably     in patients with acute renal failure. Improving fluid balance is considered crucial in the     management of patients in septic shock, but the efficacy of the measures currently proposed     (diuretics associated or not with albumin and/or dialysis) is controversial. The     investigators hypothesize that a whole-body compression using a body bandage could reduce     capillary leakage and thus lead to faster restoration of a normal transmural pressure     gradient in postcapillary venules and improve venous return.      This is the first study to evaluate mechanical compression using a body bandage to reduce     oedema in septic shock.      To do this, a whole-body compression will be set up within the 12 hours following admission.     Water balance will be monitored daily throughout the duration of the compression and vital     status of patients will be search at 7 days, 28 days and 90 days.   "
48053|NCT02656641|"     This study will assess the effects of client feedback, using the Patient Health Questionnaire     - 9 and Generalized Anxiety Disorder 7-Item Scale, on depression and anxiety in individuals     undergoing brief psychotherapy. Client feedback allows therapists to monitor treatment     progress in real time. Identifying an easily accessible treatment intervention, which     utilizes commonly used scales, that potentially enhances the effect of brief psychotherapy     and improves treatment outcomes is a valuable endeavor with clear implications for therapy     practices. It is hypothesized that clients who complete these scales each session will show     greater symptom improvement than clients who do not complete the scales.   "
48054|NCT02656628|"     The purpose of this multi-center patient registry is to obtain first clinical results and to     assess short and mid-term clinical outcome data of patients treated with DLS.   "
48055|NCT02656615|"     To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and     prior response to abiraterone.   "
48056|NCT02656602|"     Better patient education prior to colonoscopy improves adherence to instructions for bowel     preparation and leads to cleaner colons. The hypothesis of this trial is that computer     assisted instruction (CAI) using video and 3D animations can maximize the effectiveness of     nurse counselling and consequently improves bowel cleanliness. Furthermore, CAI will     positively influence the patient experience.      Adults referred for colonoscopy were included in a Dutch large volume endoscopy unit.     Exclusion criteria were illiteracy in Dutch and audiovisual handicaps. Patients were     prospectively divided into two groups, one receiving nurse counselling and one receiving CAI     and a nurse contact before colonoscopy. The main outcome, cleanliness of the colon during     examination, was measured with the Ottawa Bowel Preparation Scale (OBPS) and the Boston Bowel     Preparation Scale (BBPS). Patient comfort and anxiety were assessed at multiple time points:     directly after the instruction and one hour before colonoscopy. Comfort was rescored 2 hours     after colonoscopy. We also tested knowledge and comprehension one hour before colonoscopy.     Statistical analyses included Mann-Whitney.   "
48057|NCT02656589|"     This projective observational study is planned to enroll more than 300 advanced breast cancer     patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH)     and / or immunohistochemistry, and 100 healthy donors as control. Before treatment, the     plasma microRNA will be collected and detected by microRNA extraction kit and quantitative     polymerase chain reaction (qPCR), respectively. After analyzed their microRNA expression by     microRNA predictive model, previously reported by our team, all of enrolled patients will be     classified as probable sensitive group or probable resistant group. Herceptin combined     with other chemotherapy will be the backbone of salvage treatment and used for at least 3     months; the change of local masses and metastasis lesions after treatment will be documented     to evaluate the response. Based on these results, investigator aim to construct a     mathematical predictive model by analyzing the correlation of baseline microRNA expression     level and the prognosis of patients. And a diagnosis microRNA kit will be planned and     manufactured   "
48058|NCT02656576|"     Multicentre prospective study of concordance between two tissue sampling modes (smear /     biopsy), which applies the same diagnostic method (PCR).   "
48060|NCT02656550|"     This study aims to investigate the treatment of absolute uterine infertility (AUI) due to     congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The     investigators will follow a model based on a Swedish study to enroll 10 women with     functioning ovaries and successfully transplant the uterus from either a living or cadaveric     donor, with the goal of live birth after transplantation.   "
48061|NCT02656537|"     In this clinical investigation, the safety, feasibility and performance of the novel EnSite™     HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be     studied in patients undergoing catheter ablation procedures for the treatment of     non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).   "
48062|NCT02656524|"     The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study     should provide information about clinical characteristics of Hungarian regorafenib patients     as well as information about safety and efficacy of regorafenib in Hungarian patients with     metastatic colorectal cancer. This much needed data is required by the National Health     Insurance Fund in order to accept regorafenib into the regular reimbursement system. This     study is proposed to be based on patient data from the Hungarian National Health Insurance     Fund's Database. Data to be analyzed includes patient demography and baseline tumor     characteristics, overall survival, time to treatment failure, duration of treatment, average     dose and dose modifications, and adverse events. Further, treatment costs will be estimated.   "
48063|NCT02656511|"     The purpose of this study is to identify and provide immediate antiretroviral therapy to a     cohort of HIV-infected individuals with hyperacute infection (estimated date of HIV     infection within the last 30 days). The primary aim of the study is to evaluate whether     initiation of dolutegravir plus emtricitabine/tenofovir during hyperacute HIV infection leads     to protection of CD4+ T cells in the peripheral blood and gut-associated lymphoid tissue from     infection.   "
48064|NCT02656498|"     This is a cross-sectional and longitudinal study to evaluate the clinical utility of     [18F]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild     cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients.   "
48067|NCT02656459|"     The purpose of this study is to examine the immune response to traumatic injury and     subsequent infections in critically ill adults. Traumatic injuries lead to severe     dysregulation of the immune system, and predispose to severe infections. Diagnosing these     infections in a timely manner is paramount in reducing morbidity and mortality, but diagnosis     is made difficult by the inflammatory response to trauma. The main purpose of the study is to     prospectively test the diagnostic power of the expression of an 11-gene set which the     investigators recently published (Sweeney et al., Sci Transl Med, 2015). Since the timing of     an acquired infection cannot be determined a priori, this study is designed to be a     longitudinal examination of a cohort of traumatically injured adults. The investigators will     draw blood at regular intervals, as well as at day of diagnosis of infection for any patient     that are diagnosed with an infection. The investigators will then assay the blood for gene     expression levels post hoc, and correlate the molecular profiles with clinical information to     establish a prospective estimate of diagnostic power.   "
48068|NCT02656446|"     The purpose of this study is to determine if a handheld ultrasound device helps in the     placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound     device compared to a standard ultrasound machine.   "
48069|NCT02656433|"     30 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50%     females will participate in an interventional study in two groups: placebo and experimental     group.      Placebo group will only receive traditional treatment with physiotherapy and the Experimental     or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive Stimulation.   "
48070|NCT02656420|"     This study will examine the extent to which lower doses of a broccoli-derived beverage     enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose     shown to be effective previously.   "
48071|NCT02656407|"     A wide spectrum of methods is used to image brain activation in vivo. It can be directly     detected by neurons electrical activity imaging (cortical simulation mapping, calcium     imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the     neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical     imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic     resonance imaging (fMRI)).      Ultrasound as the potential to complement these functional imaging techniques at low cost.     Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of     major vessels has been limited until now due to its poor sensitivity. To overcome this     limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This     technique enables high spatio-temporal resolution imaging of whole-brain microvasculature     dynamics in response to brain activation without the need of contrast agent.      This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect     blood flow in most of cerebral vessels (arterioles, big venules and larger vessels).     Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow     flow dynamics in such vessels modulated by local neuronal activity.      Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal     resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human     brain in intraoperative condition.      The main objective of this study is to find activation maps through intraoperative     ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional     MRI.      Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will     be used for different types of stimuli and intensity and the investigators will do some     control acquisitions. Blood vessel density observed with a conventional Doppler will be     compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler     mode enhance micro vessel visualization.   "
48072|NCT02656394|"     To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28     days in ameliorating adverse ocular side effects in patients under ongoing treatment with     glaucoma medications.   "
48116|NCT02655809|"     The aim of this study is to assess the in vivo kinematics and range of motion of a     single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total     knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the     normal healthy knee.      Patients would be evaluated by fluoroscopic examination during weight bearing activities     (lounging, kneeling and stairs climbing).   "
48073|NCT02656381|"     Background:      Uveitis is a serious eye disease that can cause vision loss. Treatment sometimes causes     serious side effects or does not work. Researchers want to learn more about uveitis and why     some people develop it.      Objective:      To learn clinical and genetic factors that may make people develop uveitis and influence how     they respond to treatment.      Eligibility:      People ages 8 and older who have uveitis, scleritis, inflammatory eye disease, or a disease     related to eye inflammation      Design:      Participants will be screened with:      Medical history      Physical exam      Eye exam      Participation lasts up to 10 years. The clinic visit schedule varies depending on     participants eye disease:      Baseline visit with annual follow-ups      Baseline visit, visits at months 3 and 6, and annual follow-ups      Another schedule set by the researcher      Depending on participants eye disease, tests during each visit could include:      Fluorescein angiography or indocyanine green angiography: Dye is injected through a needle in     the arm      and flows through the blood vessels in the eye. A camera takes pictures of the eye.      Electroretinography: Participants sit in the dark with their eyes patched.      After 30 minutes, numbing drops and contact lenses are put in the eyes. Then, the retina is     stimulated with flashing lights.      Perimetry: Participants look into a bowl or lens and press a button when they see a light.      Conjunctival or corneal biopsy, or skin biopsy: A small piece of tissue is removed.      Anterior chamber tap: A needle enters the eye to remove fluid.      Blood and urine tests      Saliva, stool, hair, or tear samples      Cotton swab of the inside of the cheek.      During the study, participants may need immunosuppressive treatment, such as drugs or     injections in or around the eyes depending on their disease.   "
48074|NCT02656368|"     SEBORRHEAMEDIS Face Cream is a barrier-based, non-steroidal cream. The cream includes plant     extracts The cream was designed to manage the symptoms of facial Seborrheic dermatitis     symptoms such as erythema, scaling and pruritus.   "
48075|NCT02656355|"     Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies     showed that the GI difficulty was related to impaired anticipatory postural adjustments     (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were     observed before GI. In people with PD, delay and decrease amplitude of APA or abnormal     multiple APAs were observed during GI.      Conventional balance tests record the maximum displacement and/or velocity of Center of     pressure (COP). However, these variables could not show the performance of APA. Previous     studies suggested that balance and gait initiation were controlled by separate neural     circuitries. This could explain why the conventional COP measurement did not correlate to GI     very well.      It is important to develop GI related APA tests and trainings. Researchers found that a     perturbation applied before the COP displacement during GI could delay both GI and APA. This     indicates that COP displacement has APA components. Our pilot study shows that there is a     reverse direction of COP displacement before voluntary COP displacement, suggesting the     existence of APA.      This three year project will evaluate the relationship of the APA of voluntary COP     displacement and the APA of GI, establish the APA test for PD, and investigate the effect of     APA training on GI in people with PD.      In the first year, 20 people without disability will be recruited. The APA before voluntary     COP displacement test, APA before GI, and gait performance will be evaluated. In the second     year, 15 people with PD and 15 healthy people will be recruited. Subjects will receive GI     test, gait test, and APA before voluntary COP displacement test. The relationship between     different types of APA will be established for PD and healthy people. In the third year, 30     people with PD will be randomized into APA training group, balance group, and control group.     The different training effect will be evaluated especially on GI, gait performance, and     freezing of gait.      This project will advance the knowledge of mechanism of GI difficulty. The result of this     project can be applied to clinical rehabilitation of people with GI difficulty.   "
48089|NCT02656173|"     The primary objective of the study is to investigate the efficacy of mirabegron versus     placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for     BPH.   "
48076|NCT02656342|"     In this randomized controlled trial (RCT) the investigators experimentally test if patients     with Obsessive-Compulsive Disorder (OCD) who have received treatment with exposure and     response prevention (ERP), but either relapsed or not responded, profit from the combination     of concentrated exposure based treatment (cET) and the NMDA-agonist (N-methyl-d-aspartate)     d-cycloserine (DCS), targeting fear relevant areas in amygdala and pre-frontal cortex.      The project expects to demonstrate a significant improvement in all groups, and anticipate     that a higher proportion of the patients who receive DCS will show a better long-term gain     from the treatment, as compared to the placebo group at follow-up (3 mon, 12 mon, and 5 years     after treatment). In addition, the project will highlight changes in depression, sleep,     global functioning, quality of life, work and social status. Changes in medication and use of     health care will be included and related to the main objective of the study.   "
48077|NCT02656329|"     This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate     the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable     cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II     and III heart failure patients with 30%≤left ventricular ejection fraction (LVEF)≤35%, and in     particular, for identifying patients who are at low risk for sudden cardiac death and who     would not benefit, or may suffer harm, from implantation of an ICD device.   "
48078|NCT02656316|"     The current RCT aims to establish the therapeutic potential of tDCS for freezing of gait     (FOG) and motor-cognitive dysfunctions in PD. As noted, FOG is often unresponsive to     pharmacological and other treatments, especially in the advanced stages of the disease. While     it is likely that tDCS will provide symptomatic relief, we will also explore, via secondary     outcomes, the potential for tDCS to modify disease progression. Support for this possibility     stems from the likely mechanisms of action of tDCS.   "
48079|NCT02656303|"     This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab     (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms     previously enrolled in Protocol UTX-TGR-304   "
48080|NCT02656290|"     The objective of this trial is to assess the safety and effectiveness of the Edwards     Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five     years or older requiring replacement of their native or prosthetic pulmonary valve.   "
48081|NCT02656277|"     This study is a randomized controlled trial using Duke patients to test, compared to the     standard of care, a questionnaire and statistical model used to determine how patient     preference regarding shoulder pain, physical limitations, physical therapy, recovery period,     prognosis, and cost impact choice of surgical versus non-surgical intervention.      Phase 1 of this study is the initial testing of the instrument and involves a small group of     up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder     Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized     to receive either the Decision Tool or the standard Information on Shoulder Dislocation   "
48082|NCT02656264|"     The purpose of this study is to determine the effects of whether urgent or elective cesarean     section on the occurrance of chronic pain.   "
48083|NCT02656251|"     The aim of the study is to compare the effect of a suspension containing chlorhexidine and     alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival     biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will     be evaluated by means of Plaque Free Zone (PFZ).   "
48152|NCT02655341|"     Aims:        -  evaluate the hydric status through bioimpedance spectroscopy in consecutive acute          myocardial infarction patients referred for primary PCI;        -  assessment of renal artery stenosis incidence through renal angiography in consecutive          STEMI patients;        -  fully characterize the complex hydration, metabolic and endothelial profile of these          patients in the attempt to define the role played by dehydration in the complex dynamics          of acute myocardial infarction.   "
48084|NCT02656238|"     The New International CTEPH Database is a prospective, observational multi-center disease     registry run by the International CTEPH Association (ICA), which will collect data in chronic     thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for     approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode     of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes     as measured by New York Heart Association (NYHA) functional class and survival.      The data collected will improve the knowledge and understanding of this condition, support     the further development of diagnosis and treatment guidelines for patients with CTEPH, and     contribute to improving patient care in the long-term.   "
48085|NCT02656225|"     The prevalence of postpartum anemia is a great threat for maternal and infant health without     timely and effective treatment. Oral iron therapy has been used for centuries as a treatment     of anemia, however, it is noteworthy that treatment with oral iron might have a limited, and     even a harmful role in some clinical scenarios. Ejiao compound is composed with donkey-hide     glue, Ginseng, Codonopsis pilosula, prepared rhizome of rehmannia, and crab apple, which has     been widely used in the treatment of various types of anemia in China for decades and might     be a potentially effective therapy for postpartum anemia. Recently, studies involving animal     subjects have helped shed light on its mechanism of action.      In this study, the investigators aimed to conduct a randomized controlled trial to assess the     efficacy and safety of Ejiao compound comparing with oral iron in the treatment of mild     postpartum anemia with or without iron deficiency.   "
48086|NCT02656212|"     This will be a double-blind, randomized, placebo-controlled, single dose study of (+)-     epicatechin with one 30mg dose/day for a total of 7 days   "
48087|NCT02656199|"     We will investigate whether measurement of the change in thickness of the diaphragm during     the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We     will also asses whether this is only possible on low levels of pressure support as has been     shown previously, or if this technique retains its predictive power at higher levels of     pressure support.   "
48088|NCT02656186|"     The purpose of this study was to determine the improvement in nutritional status, especially     in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the     circulating cytokine levels, after providing extra protein and energy contents to     community-dwelling older adults at risk of undernutrition.   "
48093|NCT02656121|"     Recently, a special emphasis has recently been directed to the potential role of vitamin D     and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic     roles and genetic factors in the development of PCOS and its related co-morbidities. The aim     of this study is to compare the effect of vitamin D supplementation therapy and Metformin     therapy on plasma concentrations of adipokines (ghrelin, resistin and adiponectin),     follistatin and activins in participants diagnosed with PCOS.   "
48094|NCT02656108|"     This is a comparative study which will be conducted in Ain Shams University Maternity     hospital to assess the individual and specfic role of controlled cord traction as a part of     active management of third stage of labor   "
48095|NCT02656095|"     This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans.     LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein     lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no     longer functional. This can cause conditions known as high triglycerides in the blood and     inflammation of the pancreas.      Investigational medications to treat LPLD are currently being developed. In order to see if     these medications are effective, it is necessary to be able to accurately measure LPL     activity in humans.      LPL activity has been successfully measured in animal models after giving heparin. Heparin is     a blood thinner which is approved by the FDA. It is originally used to prevent blood clots.     This study will administer heparin to healthy adults through intravenous infusion (IV). Blood     samples will be collected before and after the infusion to test LDL levels.      The purpose of this study is to develop a cheap, more reliable standard for assessment of     LPLD in patients   "
48096|NCT02656082|"     The purpose of this study is to determine whether Etanercept which is given through     intradermal injection is effective in the treatment of discoid lupus erythematosus (DLE).      The investigators also would like to develop new tests to measure skin inflammation by     scanning the affected skin using optical coherence tomography (OCT), thermography and laser     doppler imaging (LDI) and taking photographs of the rash (to be done before and after     treatment). If the findings from these new tests are similar to the ones from taking a sample     of skin (biopsy), then the latter (which is an invasive test) can be avoided.   "
48097|NCT02656069|"     This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen™     (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for     hypoglycemia rescue of adult patients with type 1 diabetes.   "
48098|NCT02656056|"     The consumption of fermented soy foods can alter the human microbiome and may confer health     benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus (QC)     fermented soy beverage in humans, assessing immunological, microbiological, and clinical     parameters.   "
48099|NCT02656043|"     Phase 1/2 study enrolling 48 healthy volunteers in Phase 1 followed by 150 subjects with acne     vulgaris in Phase 2.   "
48100|NCT02656030|"     Recent studies indicate that the patients with chronic neck pain present decreased activation     and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep     are associated with pain and impairment of neck function in chronic neck pain.      Exercise is known to be an important component of treatment programs for patients with neck     pain. Recently, many studies have focused on specific training on deep cervical muscles,     especially deep cervical flexor and deep cervical extensor muscles.Numerous studies using     cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck     disability, changing in activation of deep cervical flexor muscles. Further, the cervical     extensor muscles are believed to be equally important for the rehabilitation of patients with     neck pain. However, the retention effect of semispinalis cervicis exercise is unknown.     Therefore, the semispinalis cervicis exercise still need more evidence to support clinically     effects.      The current study will be conducted to fill the gap of the previous study in immediately,     short, and long term effects of semispinalis cervicis exercise in chronic neck pain.   "
48101|NCT02656017|"     This study will test to see if metformin is safe and if it is tolerated compared to placebo     in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages     of chronic kidney disease. We will also measure its effect on progression of kidney disease     as reflected in the kidney size and the kidney function, along with its effect on kidney pain     and quality of life.   "
48102|NCT02656004|"     The essential eucalyptus oil has therapeutic potential in the cardiovascular system, with     possibilities of acting on the autonomic tonus and reduction of cardiovascular overload.     Hemodynamic conditions can change during the physical requirement and offer a framework of     increased cardiovascular risk, especially for elderly individuals. In this sense,     preservation strategies of cardiovascular autonomic control and demand in this population in     conditions of rest and/or exercise are required. The aim of this study was investigate the     effect of the essential eucalyptus oil on cardiovascular responses and recovery during     submaximal isometric resisted exercise series in the elderly. Twenty elderly male (69.1 ± 5.7     years; 75.3 ± 12.3 kg; 168.0 ± 6.0 cm) participated in this study. Were excluded from the     sample the volunteers who presented some serious illness known according to the criteria of     risk stratification of the American College of Sports Medicine. In random order crusade, the     volunteers were subjected to: 1) trial session through the essential eucalyptus oil and     inhalation; 2) session control without inhalation of essential eucalyptus oil. After the     sessions 1 and 2, the volunteers remained in recovery for a period of 60 minutes, in     temperature-controlled environment and comfortably seated. After this period were performed 3     sets of isometric resisted exercise on dominant upper limb in intensity of 30% of maximum     voluntary contraction in 1 min each, with 1 min recovery interval. Measures of heart rate,     blood pressure, rate product pressure and heart rate variability were held in the rest for 20     min, in recovery during 60 min and during the 3 sets of isometric resisted exercise.     Indicators of heart rate variability were analysed from the time and the frequency domain.     ANOVA two-way for repeated measurements with Post Hoc of Tukey were employed (p<0.05).   "
48103|NCT02655991|"     This study will determine whether telephone support improves clinical outcomes of veterans     who begin outpatient treatment for posttraumatic stress disorder. Participants will be     randomly assigned to receive either usual care or usual care supplemented by biweekly     monitoring and support by telephone during the first 3 months of treatment. Patients in both     conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking     at 4 months and 12 months after entering treatment.   "
48104|NCT02655978|"     The overall goal of this study is to employ diffusion-weighted imaging (DWI) and tractography     to investigate differences in connectivity in the rostral dorsal cingulum bundle (CB) in     patients with bipolar disorder type I (BDI) compared to matched controls, and to utilize this     information to determine if high-frequency deep brain stimulation (DBS) of the rostral dorsal     CB has realistic potential as a therapy for producing mood stabilization in patients with     BDI.   "
48105|NCT02655965|"     The aims of this study is to compare the effectiveness of pecs block associated to a general     anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and     the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy     associated with axillary dissection This is a double-blind, placebo controlled study that     will randomise breast cancer subjects in 1:1 ratio to receive a pecs block of Ropivacaine     3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).   "
48106|NCT02655952|"     The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in     the formation and dissemination of tumours. The present project focuses on the critical role     of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer     disease.      WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which     mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby     acting anti-metastatic.      The aim of the first clinical phase I study was to establish the recommended dose for a     clinical phase II study and enable further development of Foxy-5 as a first in class     anti-metastatic cancer drug. The study did not see any DLTs and therefore failed to reach     maximum tolerated dose (MTD); no recommended phase II dose (RP2D) could therefore be     established based on toxicity. The aim of this study is to continue to establish the safety     profile of Foxy-5 in higher doses, and determine the RP2D for later stage development based     on any observed DLT's/MTD and further analysis of the pharmacodynamic profile of Foxy-5 to     determine the biological response dose (BRD).   "
48107|NCT02655939|"     Reflex plus™ is a unique blend of Collagen Hydrolysate with Rosehip extract. The blend     contains individual ingredients which have been widely studied for its effectiveness in     osteoarthritis(OA). Collagen hydrolysate is accumulated in the cartilage and helps to repair     the OA, related cartilaginous changes. Rosehip works in the anti-inflammatory pathway thus     reducing the pain and inflammation of the joint.      The two open-label studies have showed the effectiveness of the investigational product on     OA. The 2 studies did not show any specific safety concern to be considered. The study     demonstrated the synergistic effect of CH and Rosehip extract from former in-vitro results in     the formulation.      The supplement has been manufactured in GMP certified manufacturing units in Germany and     India under strict quality control check. Hence, quality of the supplement and batch to batch     consistency is well assured.   "
48117|NCT02655796|"     This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the     elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the     Centers for Disease Control and Prevention (CDC).      The OAK device is a technologic system, based on virtual reality. It allows to quickly     perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The Balance     Evaluation System Test), and kinematic and posturgraphic indexes. The participants interact     with the OAK device through simple exercises, then the device provides an assessment of their     functional mobility, equilibrium and postural reactions.   "
48108|NCT02655926|"     The overarching aim is to compare the effects of ventral capsule/ventral striatum (VC/VS) and     subthalamic nucleus (STN) deep brain stimulation (DBS) in the same participants.     Investigators will test the hypothesis, grounded in cognitive neuroscience, that DBS at both     sites is better than either site alone for treating the symptom dimensions of obsessive     compulsive disorder (OCD). Specifically, Investigators will employ novel cognitive paradigms     and neurophysiological measures of cortical synaptic function to test the hypothesis that     VS/VC and STN DBS have different mechanisms of action and that alleviation of OCD symptoms is     mediated by improvement in mood/anxiety with VS/VC DBS and by directly interrupting     obsessions and compulsions with STN DBS. Investigators will additionally determine whether     adjunctive cognitive behavioural therapy (CBT) enhances the response to DBS by providing the     cognitive and behavioural skills to optimise symptom management and daily function.   "
48109|NCT02655913|"     This trial studies efficacy and safety of combination of vitamin C infusion with modulated     electro-hyperthermia (mEHT) in treatment of non small cell lung cancer patients.Phase I of     this clinical study is to find the tolerable dose and best schedule of the combination of     vitamin C infusion and mEHT that can be given to patients with NSCLC. Phase II of this study     is to learn if the combination of vitamin C infusion and mEHT can help to control NSCLC and     improve quality of life.   "
48110|NCT02655900|"     Injury to the muscles of the back passage (anal canal) is a relatively common problem. This     injury can result in problems with bowel control later in life and usually occurs during     vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently     women who have sustained injury to the muscles of the back passage undergo an ultrasound scan     by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of     the back passage has healed i.e is intact or has a defect. The investigators would like to     establish whether a 3D ultrasound scan probe placed outside the vagina can identify the     defects and hence avoid inserting the probe into the back passage. In addition to getting the     above information using 3D ultrasound scan, the investigators would also like to identify     injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed     using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury     to this muscle are known to develop prolapse later on in life.   "
48125|NCT02655692|"     The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as     compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an     active duty military and Veteran population.   "
48126|NCT02655679|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,     pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream,     twice-daily, for 28 days in otherwise healthy adult male and female patients with mild to     moderate atopic dermatitis.   "
48127|NCT02655666|"     The purpose of the study is to observe/ collect clinical data, subject users' feedback, and     device data to better understand the real-life usage and acceptance of the 722 Pump in type 1     diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China.   "
48128|NCT02655653|"     The investigators primary objective is to compare the effectiveness of epsilon-aminocaproic     acid (EACA) and tranexamic acid (TA) in reducing bleeding and transfusion in cardiac surgery,     with the hypothesis that TA is more effective. The investigators also seek to further examine     the clinical benefits and adverse effects profiles of epsilon-aminocaproic acid and     tranexamic acid.   "
48111|NCT02655874|"     TROPICS1 is a randomized, observer-blind, active comparator-controlled, single-center, Phase     IV trial in 200 participants aged ≥65 years. The control group will receive a standard dose     licensed trivalent inactivated influenza vaccine at day 1, and an active-comparator     (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group     will receive the same influenza vaccine at day 1 and day 180. Endpoints are immunological,     and include measures of haemagglutination-inhibition (HI) titres, micro-neutralisation titres     and cell-mediated immunity at 4 time points after the initial vaccination up to Day 360. The     primary hypothesis is that participants receiving an influenza booster at day 180 will     achieve superior influenza seroprotection (HI titre ≥1:40) at day 208, compared to controls.      The World Health Organization (WHO) estimates the global annual burden from seasonal     influenza as 1 billion infections, with 3-5 million severe cases and 300,000-500,000 deaths.     The pattern and impact of these infections varies considerably with climate. In temperate     countries, influenza epidemics characteristically occur during the cold winter months, while     in sub-tropical countries, they coincide with the rainy seasons. Closer to the equator,     influenza virus activity is more complex. In Singapore, biannual epidemics are usual, but     with continuous transmission year-round. Bi-annual epidemics, tri-annual epidemics and year     round virus activity have also been described in other tropical countries, from Indonesia and     Malaysia to Peru and Mexico.      There is no published data reporting year-round influenza vaccine effectiveness in the     elderly from countries with continuous influenza virus activity. Despite numerous studies     worldwide exploring the HI antibody response to influenza vaccination, the majority of these     do not continue follow up beyond seroconversion (21-28 days). However, of the few available,     HI antibody titres declined following influenza vaccination in the elderly, such that within     6-12 months geometric mean titres approached pre-vaccination levels. With biannual epidemics     and year-round transmission in tropical regions, year-round seroprotection may be important     to reduce influenza infections in this environment. A six-monthly vaccination cycle would     correspond with the decline in vaccine-induced seroprotection in the elderly, and the     6-monthly periodicity of outbreaks in Singapore and other tropical countries.   "
48112|NCT02655861|"     This project will follow babies with ichthyosis over time in order to better understand the     natural course of ichthyosis in infants and children and to examine how specific genetic     mutations affect clinical characteristics.   "
48113|NCT02655848|"     During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions     are frequently encountered. However, the most optimal treatment of the diseased long head of     the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or     tenodesis. The hypothesis is that there is no difference in functional outcome between LHB     tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.   "
48114|NCT02655835|"     Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase     meditation practice as compared to another meditation program. The study will last six weeks     for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will     receive learning materials and guided meditations, but the implementation will be self-paced.     Participants in the IMMI group will receive weekly learning sessions and be required to     practice meditation every day. IMMI group participants will also receive a weekly reminder     call from a member of the study staff and have access to technical support in the event of     trouble with the online program. All subjects will complete online self-report questionnaires     that measure quality of life, self-efficacy, mood, sleep, mindfulness, and perceived stress     at baseline and at the end of the six-week intervention. Subjects will also be given a     questionnaire at the end of the study gauging their satisfaction with the mindfulness program     they participated in.      Phase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to     participants and demographic information about IMMI users. The study will be the same as     noted above, but all subjects will be entered in the IMMI program.      Differences in recruitment rates, drop out, and patient satisfaction between the IMMI and     Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e. increasing     time or frequency of meditation sessions), and improve quality of life will be examined as     well.   "
48115|NCT02655822|"     This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small     molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune     system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as     a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid     tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the     anti-tumor activity of T cells and other immune cells.   "
48118|NCT02655783|"     The objective of this study is to compare the effects of use of normal saline (250 cc / h),     with or without dextrose supplement, on the evolution of labor in nulliparous.   "
48121|NCT02655744|"     Background. Primary central nervous system lymphoma (PCNSL) is an uncommon disease.     Conventional treatment has consisted of either whole brain radiotherapy (WBRT) or     methotrexate (MTX)-based combined modality therapy combining chemotherapy and cranial     irradiation. The treatment principles at our institute have been quite consistent in the     past, sticking to the treatment protocol reported by Memorial Sloan-Kettering Cancer Center     in 1990s. No matter what the dosage of MTX is, it is well-established that the addition of     chemotherapy to cranial RT significantly improved survival outcomes. However, it was found     that delayed treatment-related cognitive sequelae emerged as a significant debilitating     complication of combined modality treatment in patients with PCNSL, especially when effective     treatment can achieve disease control and better survival rates. Furthermore, the specific     contribution of the disease per se and various treatment modalities to cognitive impairment     remains to be clarified because the neurotoxic potential of combined modality treatments is     difficult to differentiate when each can result in cognitive dysfunctions respectively.      Treatment-related neurotoxicity could be demonstrated by virtue of several meaningful     indicators, including neurobehavioral assessments, neuroimaging outcomes, and even measures     of quality-of-life (QoL).      Methods. Therefore, this one-year individual research will be a prospective observational     cohort study with a longitudinal assessment of neurobehavioral functions, neuroimaging, and     quality of life for newly-diagnosed patients with primary CNS lymphoma at our institute.     According to our cancer center, it is estimated that there would be around 25 cases of     newly-diagnosed primary CNS lymphoma at our institute every year. By virtue of     multidisciplinary management and teamwork consisting of neurosurgery, hematology, radiation     oncology, neuroimaging expertise, and surgical pathology, investigators will attempt to     recruit all potentially eligible patients with newly-diagnosed primary CNS lymphoma. Most     importantly, the neuropsychologists will participate in our research project, in an effort to     integrate the neurobehavioral outcomes into this prospective study. Accordingly, a battery of     neuropsychological measures is used to evaluate neurobehavioral functions for the studied     patients. The battery is composed of ten standardized neuropsychological tests, covering four     domains sensitive to disease and treatment effects (executive function, attention, verbal     memory, psychomotor speed), and QoL questionnaires.      Expected results. This prospective cohort study aims to explore and evaluate patients with     PCNSL who are newly-diagnosed by using a standard battery of neurobehavioral functions plus     neuroimaging studies. It is anticipated investigators will investigate and correlate     neurotoxicity indicators in newly-diagnosed patients with PCNSL who are treated with cranial     radiotherapy combined with or without MTX-based chemotherapy according to the     multidisciplinary treatment guidelines implemented at a single institute.   "
48122|NCT02655731|"     Aim of the present prospective, single-centre study is to determine the outcome after pure     PVI using HeartLight™ in 100 patients with different extents of LA-LVA.      The latter will be assessed by an electro-anatomical voltage map using a commercial 3D     mapping system (CARTO, Biosense Webster).   "
48123|NCT02655718|"     The purpose of the study is to assess short and long term outcomes of acute coronary syndrome     in patients with non obstructive coronary atherosclerosis, to optimize the algorithm for     diagnosis and to evaluate its effectiveness   "
48124|NCT02655705|"     This study evaluates the performance of objective psoriasis severity assessment tool compared     with a subjective assessment tool for the assessment of the improvement of psoriasis after     oral cyclosporine A or methotrexate treatment.   "
48129|NCT02655640|"     This research project has the overall objective to investigate the direction of the     associations between illness perceptions, their influencing factors and health-related     outcomes. Moreover, the investigators want to look at the direction of the associations     between illness perceptions and health related outcomes such as psychological and physical     functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc).     The investigators want to know whether the outcome variables anxiety, depression, physical     (dis) functioning are influenced by illness perceptions or vice versa. Not only the patients'     illness perceptions but also the illness perceptions of the General Practitioners (GP) and     rheumatologists will be investigated. The researchers want to know if the doctors'     perceptions have an impact on the physical and psychological functioning of the patient or     vice versa. Much research in the field of illness perceptions is cross-sectional in nature     which means that the direction of the relationships between variables is not known.   "
48130|NCT02655627|"     Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance and     exercise has positive effects on glycemic control and cardiovascular disease (CVD)     development in these patients. Encouraging physical activity and exercise with using     internet-based technology provides; potential to reach more people via comparatively low     cost, 24 hour accessibility to services and for clinician, more frequent communication     ability with the patient. In literature, there is no study examined exercise training via     internet in patients with Type 2 DM. For this reason, considering the lack of the literature,     the investigators aimed to compare the effects of internet based combined exercise training     on glycemic control, functional capacity and physical activity level with supervised group     training in patients with Type 2 DM. The purpose of the study is to provide convenience of     rehabilitation access, glycemic control, offer an alternative physiotherapy and     rehabilitation service which can help to improve physical activity level and obtain     quantitative data for the applicability and contribution of internet based exercise training     in patients with Type 2 DM.   "
48131|NCT02655614|"     This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in     participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and     pharmacokinetic (PK) properties of GDC-0134. It will include two components: a     Single-Ascending-Dose (SAD) stage and a Multiple-Ascending-Dose (MAD) stage.   "
48153|NCT02655328|"     This study will determine the pharmacokinetic profile of the salbutamol concentration in the     urine while athletes are resting or during exercise.   "
48154|NCT02655315|"     This study evaluates the effect of iron chelation as a therapeutic strategy to slow the     progression of Parkinson's disease. Half of participants will receive the deferiprone to 15     mg / kg twice daily morning and evening (30mg / kg per day), while the other half will     receive a placebo. The treatment lasts nine months.   "
48132|NCT02655601|"     This is a Phase 1/2 study of newly diagnosed patients with high grade glioma (HGG) undergoing     standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and     temozolomide has the potential not only to benefit the survival of high grade glioma patients     but also to protect against deterioration of cognition and impairment of quality of life. In     Phase 1 safety and tolerability of BMX-001 will be assessed using a two-stage Continual     Reassessment Method (CRM). BMX-001 will be given subcutaneously first with a loading dose     zero to four days prior to the start of chemoradiation and followed by twice a week doses at     one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase 2     both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be     assessed. Twenty-four patients will be randomized to the treatment arm that will receive     BMX-001 while undergoing chemoradiation and 24 patients randomized to receive chemoradiation     alone. The investigators hypothesize that BMX-001 when added to standard radiation therapy     and temozolomide will be safe at pharmacologically relevant doses in patients with newly     diagnosed high grade glioma. The investigators also hypothesize that in Phase 2 of this     study, the addition of BMX-001 will positively impact the overall survival and improve     objective measures of cognition in newly diagnosed high grade glioma patients.   "
48133|NCT02655588|"     The primary purpose of this study is to examine how much change in depressive symptoms will     be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to a     control group at pre-, mid-point, and post-test assessments.   "
48134|NCT02655575|"     Brief Summary:      The purpose of the present study is to examine the effects of a Group based intervention     consisting of vestibular rehabilitation (VR) combined with cognitive behavioral therapy (CBT)     in patients with long--lasting vestibular dizziness. The study also aims to describe     sociodemographic, physical and psychological characteristics in the patients, and to examine     prognostic factors related to functional status and disability following participation in the     intervention.   "
48135|NCT02655562|"     Cough is a common symptom that leads patients worldwide to seek medical attention. Subacute     cough refers to a cough of 3-8-week duration, and is typically refractory to standard     anti-tussive therapy, and a tendency to spontaneous healing was common. Few clinical trials     have evaluated therapeutic options for subacute cough. Airway inflammation is an important     feature of most of subacute cough, Cysteinyl leukotrienes and FeNO correlates with airway     inflammation. Subacute cough often represents a prolonged post-viral response. Cysteinyl     leukotrienes increase in virus infection. Airway inflammation induce epithelial cells produce     iNOS(inducible nitric oxide synthase,iNOS), and FeNO increase in theory. Montelukast is a     cysteinyl leukotriene type 1 receptor antagonist that is reported to improve cough16 and     reduces FENO and prevents increases in FENO during reduction of inhaled corticosteroid dose,     But A meta-analysis of the effectiveness of LTRA( leukotriene receptor antagonist,LTRA)in     treating children with prolonged non-specific cough concluded that, with the lack of     evidence, the routine use of LTRA in treating children with non-specific cough cannot be     recommended. A randomised, placebo-controlled trial showed montelukast is not an effective     treatment for postinfectious cough. Non-specialists or general practitioners of Japan     prescribe LTRA very often, which increase. The aim is to research whether FeNO can be used as     a biomarker to direct montelukast treatment and optimize treatment regimen of sub-acute     cough.   "
48136|NCT02655549|"     The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.   "
48159|NCT02655250|"     This is a validation study to compare proposed field collection methods with a gold standard     collection technique for microbiome analysis of stool and breast milk samples.   "
48137|NCT02655536|"     This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers     in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone.     This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases.      The primary objective is to compare the systemic progression-free survival (PFS) to     bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have     asymptomatic brain metastases.   "
48138|NCT02655523|"     Greater occipital nerve (GON) injection is a commonly performed diagnostic and therapeutic     procedure in headache patients. GON blocks have been shown to be effective in the treatment     of a variety of headaches including occipital neuralgia, migraine, vascular headache, cluster     headache, cervicogenic headache, and post-concussive headache. Local anesthetic and steroids     have been successfully used for diagnostic and or therapeutic nerve pain such as lumbar     radicultis with great success. Dexamethasone is a water soluble steroid, when combined with     local anesthetic; it may increase the analgesia of block duration relative to its     pharmacokinetics. When compared to dexamethasone, triamcinolone, a particulate steroid has a     slower onset time but may provide anti-inflammatory effects up to several weeks.     Investigators want to investigate to see if there exists a difference in reported pain     intensity using the particulate anti-inflammatory corticosteroid (triamcinolone with     bupivacaine) which may provide a greater reduction in reported pain intensity relief may     allow the patient to undergo fewer interventional procedures.   "
48139|NCT02655510|"     Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with     long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients     who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis,     marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of     portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However,     milder forms of alcoholic hepatitis often do not cause any symptoms.      Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use     continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months,     sometimes without permanent sequelae but often with residual cirrhosis.      F-652 is a recombinant fusion protein containing human interleukin 22 (IL-22) and human     Immunoglobulin G2 (IgG2)-Fc produced in CHO cells in serum-free culture. F-652 under     development is intended to treat patients with graft vs host disease (GvHD) after bone marrow     transplantation, and acute alcoholic hepatitis (AAH), a severe form of alcoholic liver     disease (ALD). Both GvHD and AAH are diseases with unmet medical need. The current     investigational new drug (IND) application is to conduct a phase Ia clinical study in GvHD     patients to evaluate the safety and pharmacokinetic profile, and biomarkers of F-652     treatment by intravenous infusion (IV).      IL-22 is a member of the IL-10 family of cytokines which control bacterial infection,     homeostasis, and tissue repair. IL-22 may be used to treat patients with ALD because of its     antioxidant, anti-apoptotic, anti-steatotic, anti-microbial, and proliferative effect that     have been demonstrated in various experimental systems.   "
48143|NCT02655458|"     The purpose of this study is to explore the combination of Elotuzumab in combination with     autologous stem cell transplantation and lenalidomide maintenance to see what side effects it     may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed     and treated with induction therapy in the past year.      Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction     therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and     the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks.      An autologous peripheral blood stem cell transplant is a procedure in which immature stem     cells are collected and stored for future use. A high dose of chemotherapy is given to the     patient to destroy myeloma cells, and the patient's stem cells are replaced.      The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608.     Elotuzumab is a manufactured protein directed against a target found on multiple myeloma     cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and     cyclophosphamide, the drugs used during stem cell collection and transplant, are also     approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and     is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an     FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs     to treat multiple myeloma.   "
48144|NCT02655445|"     Setup of comparative trial The goal of this study is to determine whether one surgical     treatment for chronic subdural hematoma is better than the other. Patients with a clear     indication for drainage of subdural hematoma (as stated under Surgical options) will be     randomized into three groups. One group will receive twist drill craniostomy followed by     drainage during 48 hours. One group will undergo burr hole drainage (single if possible,     double if necessary) with irrigation and drainage during 48 hours postoperatively. One group     will undergo a minicraniotomy with trephine or craniotome, with wide opening of all visible     membranes, rigorous irrigation and placement of Jackson-Pratt drain, followed by closed     system draining during 48 hours. Postoperative results and complications will be compared     between the three groups.   "
48145|NCT02655432|"     Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk     factors with the use of the Spot photoscreener. The photoscreener results will be compared to     the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the     performance of the spot photoscreener in the haitian children population. Secondarily, this     study will gather epidemiological information on vision problems in the haitian children     population.   "
48146|NCT02655419|"     Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the     treatment of hospitalized adults with cIAI   "
48147|NCT02655406|"     This study will be looking at the effect of compression therapy in patients having endovenous     treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either     the compression group (group A) or the no compression group (group B).      The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as     the cost effectiveness of each intervention will be assessed.   "
48160|NCT02655237|"     The purpose of this study is to evaluate the efficacy of TAK-385 40 mg administered orally     once daily for 12 weeks, compared with leuprorelin injection (once/4 weeks, 1.88 mg or 3.75     mg SC/time) in participants with uterine fibroids.   "
48148|NCT02655393|"     Part A:      The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly     male and female volunteers. Each subject will be randomized for two subsequent doses in three     cohorts.      Part B:      The study is a double-blind, randomized, multiple ascending doses study in 36 healthy elderly     male and female volunteers. Subjects will be randomized to receive study product or placebo     for 28 days.   "
48149|NCT02655380|"     Ketamine and opioid are known to improve the intubating condition, respectively. Combination     of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in     complementary manner. Therefore, the combination use of ketamine and remifentanil could be     useful for acceptable intubating condition in the general anesthesia without the use of     neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2     mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine     induction dose for intubation without neuromuscular blocking agent. The investigators focus     on remifentanil dose using Dixon's up and down method.   "
48150|NCT02655367|"     This crossover study is designed to compare the gastric layering and rates of emptying and by     inference rates of digestion of two different porridge meals prepared from either finely     milled or flaked oats. On each of two study days, a total of 9 MRI scans will be taken, I     baseline and 8 post meal, to assess gastric layering and emptying over three hours. Blood     samples will also be taken periodically over the same period in order to determine changes in     concentrations of circulating glucose, insulin and key gastrointestinal hormones.     Participants will also be asked to complete a questionnaire at predetermined times to assess     feelings of satiation.   "
48151|NCT02655354|"     The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems     Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic     clinical trial demonstration project that directly informs national trauma care system policy     targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and     related comorbidity. Each year in the United States (US), over 30 million individuals present     to trauma centers, emergency departments, and other acute care medical settings for the     treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol     and drug use problems, depression and associated suicidal ideation, pain and somatic symptom     amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease,     diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and     without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management     treatment models for PTSD and related comorbidities exist. These care management models have     the potential to be flexibly implemented in order to prevent the development of chronic PTSD     and depressive symptoms, alcohol use problems, and enduring physical disability in survivors     of both TBI and non-TBI injuries; care management models may also be effective in mitigating     the impact of the acute injury event on symptom exacerbations in the large subpopulation of     injury survivors who already carry a substantial pre-injury burden of multiple chronic     medical conditions.   "
48680|NCT02648438|"     This is an open-label,partially randomized, four-period study in healthy male subjects to     assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered     intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a     pressurized meter-dose inhaler (pMDI)   "
48155|NCT02655302|"     Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of     the airways linked to environmental exposure. The chronic course of COPD is often interrupted     by acute exacerbations which have a major impact on the morbidity and mortality of COPD     patients. A bacterial etiology for these exacerbations is common (almost 50%). Moreover,     airway bacterial colonization linked to an increased susceptibility is observed in COPD     patients. Effective Th17 immune response is needed to develop a good response against     bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22     response to bacteria in COPD leading to airway bacterial colonization and infection.   "
48156|NCT02655289|"     Pain is the most common symptom (ca. 80% of patients) on German Palliative Care units and     thus, pain control plays a central role in palliative care.      Transcutaneous electrical nerve stimulation (TENS) is a complementary treatment option for     patients who experience suboptimal pain control. However, the evidence for the efficacy of     TENS in cancer patients is not unambiguous.      The present study is a double blind, placebo-controlled cross-over trial with a short-term     follow-up.      The primary aim of this study is to evaluate the efficacy and safety of TENS for cancer pain     reduction in advanced cancer patients.      The secondary aim is the explorative identification of subgroups that benefit or do not     benefit from TENS.   "
48157|NCT02655276|"     This study is designed to investigate effects on attentional performance and motoric activity     of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after     treatment with t.i.d. sublingual doses over 3 weeks each.      The primary objective of the study is to determine the effects on attentional performance and     motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to     placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low     attentional performance and high motoric activity.      A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance     and high motoric activity will be enrolled in this study. The prepuberal status will be     determined by Tanner stages ≤ 3.   "
48158|NCT02655263|"     Background: Humans naturally produce ketone bodies under daily living conditions. The main     ketone bodies are two functioning acids, beta-hydroxybutyric acid (3-OHB) and acetoacetate,     and the pH-neutral, but odorous, acetone. In the fed state, level of 3-OHB is suppressed to     an almost unmeasurable level while, in the fasted state, it rises to 0.1-0.5 millimoles (mM).     Main regulation of ketone synthesis is the abundance of sugars and resulting adaptations in     insulin secretion. Thus, ketone bodies are formed when sugar is not readily available and     insulin is suppressed. This picture is, to a certain degree, seen in acute inflammatory     states and, indeed, during starvation, where level of 3-OHB increases to 5-8 mM.      Hypothesis:        1. Ketone bodies changes the insulin sensitivity and substrate metabolism in human subjects        2. Ketone bodies changes the GH signaling in muscle and adipose tissue      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in     signaling pathways and insulin sensitivity during GH infusion and concomitant ketone bodies     infusion among healthy subjects.   "
48165|NCT02655172|"     Brief Summary: In schizophrenia, dislocation of psychic functions involving a loss of contact     with reality is frequently found. A fragmentation of motor and sensory perceptions could be     held responsible. However, automatic integration between perception and action is the     necessary condition to be in relationship with the world. Affordance is the experimental     link between object perception and potentially associated actions (Gibson, 1977, 1979)     explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker & Ellis sensory motor     compatibility task (1998), with a modified response device (responses given with grasp), we     study the impact of motor activation on these affordance effects. In this study, a group of     controls will also be included in order to understand, as precisely as possible, the     mechanisms involved (i.e., interference between the perception of the object and the response     gesture).   "
48166|NCT02655159|"     This is a national, multicenter, retrospective, observational post-authorization study     (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up     to the start of the study. In each case, only data from before the start of the study will be     obtained in order to ensure they are retrospective in nature, thus reflecting the regular use     of nab-paclitaxel in clinical practice and avoiding interference with the physician's     clinical practice.      To ensure the observational nature of this study, these data will be collected whenever they     are available in the patient's medical record, and so no diagnostic or therapeutic     intervention outside regular clinical practice will be used.   "
48167|NCT02655146|"     The aim of the present prospective randomized controlled study was to determine the effects     of GnRHa add up to routine luteal phase support on frozen embryo implantation in frozen     embryo transfer (FET).   "
48681|NCT02648425|"     This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in     combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a     view to identifying the recommended Phase II dose.   "
48168|NCT02655133|"     IgM-enriched immunoglobulins (IgGAM; Pentaglobin ® ) are new therapy for sepsis and septic     shock since they support immune system especially in case of  immunoparalysis . However     IgGAM isn't commonly prescribed, few centres use it as routine in severe infections and there     aren't any guidelines to determine how and when to use them.      Microcirculatory dysfunction is a crucial aspect in the pathogenesis of sepsis-induced organ     dysfunction, resulting in hypoperfusion and tissue hypoxia. Unpublished clinical data suggest     a beneficial effect of IgGAM at microvascular level proved with near infrared spectroscopy     and Vascular occlusion test (VOT).      This study is a double blind phase II prospective randomised controlled trial that will     include patients admitted to the Intensive Care Unit of the University Hospital Ospedali     Riuniti of Ancona, after no more than 24 hours from development of severe sepsis or septic     shoc.      Patients will be randomized into two groups (treaties and controls): patients in group of the     treaties will be submitted to infusion of IgGAM conjugate (Pentaglobin ®) at dosage of 250     mg/kg IV (5 mL/kg) per day (rate of 0.4 mL/kg/h), for 72 hours. The controls will receive     equal amount of physiological NaCl solution (0.9%) as placebo. Neither the patient nor the     staff nurses and MD will be aware of the group and of the treatment applied. IgGAM solutions     or NaCl 0.9% will be provided by the hospital pharmacy in similar bags. The remaining     treatments will not be changed in any way and will be at the discretion of the doctor who's     in charge of the patient. All patients of the two groups will receive the optimal therapy for     their conditions, according to good medical clinical practice (GMP), with appropriate     antibiotic therapy, vasoactive and infusional therapy   "
48169|NCT02655120|"     The main objective of the study is to evaluate the effectiveness of the injection of bone     marrow unconcentrated more R BMP 7 to repair necrosis of the femoral head with stage I-III     classification FICAT.   "
48170|NCT02655107|"     Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective     congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared     to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM     3500 premiere).   "
48171|NCT02655094|"     Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some     cases severe complications, sometimes causing extracorporeal life support. The investigators     have observed over several years 5 cases of instantaneous postoperative severe pulmonary     edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery     procedure.   "
48172|NCT02655081|"     To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with     a preoperative high-arginine nutritional supplement. The investigator will measure patient     adherence to the regimen, tolerability of the supplement and feasibility of supplementation.     Secondary outcome measures will include differences in length of stay and complication rate     between groups.   "
48173|NCT02655068|"     The null hypothesis is that patients screened by PET/CT will not have detection of disease     recurrence any earlier than those screened by CT alone. The alternative hypothesis is that     PET/CT surveillance will lead to detection of disease recurrence 3 months earlier than CT     surveillance. Furthermore, to reject the null hypothesis, earlier detection must be     associated with a cause-specific survival improvement of 10%. Primary endpoints will include     time from the completion of definitive therapy to diagnosis of recurrent disease, and     absolute survival within 3 years after completion of initial therapy. Duration of survival     between diagnosis of recurrence and subsequent death will not be a primary endpoint because     the investigators expect that PET/CT will offer an opportunity for earlier recognition of     recurrence and be subject to lead-time bias. Duration of survival will be measured from     completion of primary treatment until death. Note: the presence of residual disease at     surgical consolidation does not constitute a recurrence event.   "
48174|NCT02655055|"     A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be     performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood     donors. The primary outcome measure will be clinically significant decline in BMD at the     lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).   "
48187|NCT02654886|"     The purpose of this research study is to determine if exercise will help improve muscle     strength, endurance, and quality of life in individuals with Pompe disease. This is a     research study to further define the outcome of patients with Pompe disease treated with a     combined diet and exercise therapy.   "
48175|NCT02655042|"     The primary purpose of this study is to assess the long-term safety profile of RCT-01     injections as compared to placebo injections. This study will also measure the long-term     impact these injections will have on tendon structure and function and the symptoms of     Achilles tendinosis.      This is study is designed to follow participants who have completed participation in a     clinical trial where they received injections of either RCT-01 or placebo in the Achilles     tendon. No clinical interventions will be performed as part of study procedures.      The day of study entry (Visit 1) will be coordinated with the participant's final visit in     the earlier clinical trial. All participants will return to the clinic for repeat assessments     of their Achilles tendinosis and overall health 6, 12 and 18 months after study entry.     Furthermore, they will complete 'telephone visits'; during which they will report information     on their overall health; 3, 9, and 15 months after study entry. Total duration of patient     participation is approximately 18 months.   "
48176|NCT02655029|"     The main objective of this study is to record, in routine clinical practice, patients'     adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination, during     4 months treatment.   "
48177|NCT02655016|"     This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in     patients with Stage III or IV ovarian cancer. Patients must have completed front-line     platinum based regimen with a physician-assessed response of Complete Response (CR) or     Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer     antigen 125 (CA-125) following front-line platinum treatment. The study will assess the     efficacy of niraparib as maintenance treatment, as measured by PFS.   "
48178|NCT02655003|"     Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the     course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of     neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical     framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the     effects of TIME on NPS in nursing homes patients with dementia and the implementation process     at staff and organization level.   "
48714|NCT02647996|"     To compare functional connectivity after severe traumatic brain injury (TBI) between a group     of post-comatose TBI with restored consciousness and a group of post-comatose TBI with     persistant disorder of consciousness at admission in rehabilitation   "
48179|NCT02654990|"     The purpose of this study is to investigate the safety and efficacy of three different     regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex     and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a     randomized, 3-arm parallel design. This study will also assess the impact of administering     s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly     starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75     years of age will receive for the entire treatment period s.c. BTZ weekly (in combination     with PAN and Dex) until disease progression.      Patients will be treated until disease progression or until they discontinue earlier due to     unacceptable toxicity or for other reasons.      Patients who discontinued study treatment for reasons other than disease progression will be     followed for efficacy every 6 weeks.      All patients will be followed for survival until the last patient entering long-term     follow-up has completed a 3 year survival follow-up or discontinued earlier.   "
48180|NCT02654977|"     The study investigators' aim is to determine the long term safety and efficacy of Metreleptin     (Myalept,) in promoting amelioration of metabolic abnormalities in patients with all forms of     partial lipodystrophy. Patients will be offered this protocol under the following condition:     Subjects have completed University of Michigan research protocol MB002-014 and have shown     improved clinical benefit as judged by clinical criteria set forth in this protocol.   "
48181|NCT02654964|"     A study to determine the safety of CSC/ HTS-based combination drug therapy in subjects who     have GBM that has recurred or progressed following prior radiation therapy and TMZ.   "
48182|NCT02654951|"     The project targets stroke survivors to investigate the effect of augmented feedback (using     robotic force cues and visual feedback) on their upper limb reaching patterns and trunk     compensatory movements.   "
48183|NCT02654938|"     Phase I single-blinded, randomized, placebo-controlled trial evaluating safety, tolerability,     pharmacokinetics and pharmacodynamics of single injections of ascending doses of     investigational drug product Mobilan (М-VM3) administered directly into the prostate of     patients with prostate cancer.   "
48184|NCT02654925|"     In order to design new programs to help prevent weight gain, promote successful and     sustainable weight loss, and help treat diseases related to obesity, the investigators need a     better understanding of why accumulating fat in certain regions of the body is bad for     health. It is known that not all fat cells are the same, but it was recently discovered that     some fat cells may arise from stem cells that come from the bone marrow (bone marrow     progenitors), a previously unrecognized origin. This discovery has been paradigm shifting,     because dogma has long held that all white fat cells arise from fat tissue resident     mesenchymal stem cells. This is also important because fat cells arising from the bone marrow     lineage may be linked to worse health outcomes. The aim of this study is to determine if     cells that were not previously believed to contribute to fat generation in humans are indeed     capable of becoming fat cells. To answer this question the investigators will take samples of     cells from the blood and the fat tissue of younger and older men and women, isolate the cells     that came from the bone marrow and grow them in culture to determine if they will turn into     fat cells. The results of this investigation may reveal potential mechanistic targets for     future therapies to reduce the negative health outcomes associated with obesity related     chronic diseases.   "
48185|NCT02654912|"     This study is designed to compare the effectiveness of reactive focal drug administration     (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat     (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and     eliminating malaria transmission as measured through achieving zero seropositivity in     children under five in Southern Province, Zambia. These two strategies are potential     candidates for expanded malaria operational surveillance and elimination for low malaria     transmission areas.   "
48186|NCT02654899|"     The current study is the first clinical trial proposed with PF-06815345. It is designed to     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of     single oral doses of PF-06815345 to healthy adult subjects.   "
48189|NCT02654860|"     The objective of the study is to investigate the efficacy and safety of a single intrathecal     injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared     to placebo solution, for post-operative analgesia of hip replacement surgery performed under     spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4     treatment groups (15 patients per group) to receive either one of the 3 single doses of     paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution) by     intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration, all     patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤ 160     cm-tall patients and 15 mg for > 160 cm-tall patients). The time interval between paracetamol     IT and bupivacaine IT administrations should not exceed 2 min.      The study will include a screening phase (Visit 1, Days -21/1), a treatment phase     (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a     follow-up phase including an observation period (Visit 3, from Day 1 after surgery until     discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be     assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24,     27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a     0-100 mm VAS.   "
48203|NCT02654678|"     Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart     failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12     years of age at recruitment into the preceding short-term pharmacokinetic     (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all     children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as     acceptability and palatability assessments in children still under enalapril Orodispersible     Minitablet (ODMT) treatment.   "
48190|NCT02654847|"     Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery     (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and     vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension     includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor     used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac     output, which may be a concern in an already compromised fetus. Norepinephrine is commonly     used in high concentrations in intensive care and recent studies have suggested that in low     concentrations it may be a better alternative to phenylephrine in elective CD, as it does not     reduce the maternal heart rate or cardiac output. The optimum bolus dose of norepinephrine to     prevent hypotension after spinal anesthesia in elective CD has not been elucidated. The     investigators propose this study to determine the dose that would be effective in 90% of     patients (ED90).      A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent     hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of     approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately     6 µg, given that the current phenylephrine bolus dose at the investigators' institution is     approximately 100 µg.   "
48191|NCT02654834|"     The purpose of this study is investigate to the effect(s) of chronic occupational exposure to     N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the generation     of the biochemical markers) in operating room staff, with different levels of exposure to     halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care Staff), and to     determine the relationship between the degree of oxidative stress and psychological stress,     as assessed by validated psychometric measures.   "
48192|NCT02654821|"     Patients with stage IV melanoma (also eye melanoma) will be treated with TCR transduced     cells.   "
48193|NCT02654808|"     The purpose of this study is to compare CO2 absorption during gynecologic laparoscopy using     the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal     pressures of 10 and 15 mmHg.      The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic     laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant     decrease in CO2 absorption, while maintaining adequate visualization of the operative field     for safe completion of surgery.   "
48194|NCT02654795|"     Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF).     Numerous factors predisposing to peripheral embolism in patients with AF have been well     defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation     minimizes the risk attributable to known risk factors, stroke may still occur. Thus,     unknown risk factors may play an important role in stroke risk stratification in patients     with AF. The investigators assume that one of the important unknown risk factor is left     atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after     ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the     time of stroke. The control group will consist of 100 patients scheduled for AF ablation     without a history of stroke or TIA.   "
48195|NCT02654782|"     Looking at individual total fluid volume and alveolar-arterial gradient with 5% human albumin     and Lactated Ringer's in the perioperative cardiac surgical patient.      Our hypothesis is that the individual total fluid volume and alveolar-arterial gradient will     be less with 5% human albumin compared to Lactated Ringer's in the perioperative cardiac     surgical patient.   "
48196|NCT02654769|"     The objective of this study was to evaluate the safety and therapeutic equivalence of generic     ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the     efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis     (AK) on the trunk or extremities.   "
48197|NCT02654756|"     While there are proven therapies that slow CKD progression, these therapies can at times be     harmful and costly. The ability to accurately predict the risk of CKD progression to ESRD     would be extremely valuable. The short term versus lifetime risk of CKD progression should be     taken into account when making risk based clinical decisions. In a representative CKD     practice, the investigators compared the short term and lifetime risk assessment in our stage     3 CKD patients to determine whether decisions based on a short term risk assessment would     underestimate the lifetime risk of CKD progression. The investigators also applied the short     term risk assessment to our stage 4 CKD patients to determine the frequency with which ESRD     risk may be overestimated in CKD stage 4.   "
48201|NCT02654704|"     To follow longitudinally healthy and immune-compromised responses to pneumococcal     vaccination, in 60+ individuals towards the development of personalized medicine     implementation (minimum enrollments in 2 age categories: young adults[18-25], older adults     [55+], within each category: 10+ healthy, 10+ asthma, 10+ immune-compromised [e.g. leukemia     or autoimmune disorders]). The approach will profile thousands of molecular components     utilizing high-throughput technologies and integrate these data to obtain personalized immune     response to vaccination. The study will provide insights into immune response mechanisms     specific to asthmatics, immune compromised and healthy individuals, as well as in response to     vaccination. Additionally the differences in dynamic response across the two age groups will     be investigated.   "
48202|NCT02654691|"     This is a clinical study which is a follow-up of a previous prospective questionnaire study.     All patients who previously participated in the study will receive a new questionnaire and     will be invited for a clinical examination.   "
48749|NCT02647541|"     The hypothesis of this study is a nutrition preoperatively in infants and children undergoing     elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional     status, intervention, and that this results in good postoperative results.   "
48204|NCT02654665|"     Non-alcoholic fatty liver disease (NAFLD) is defined by presence of hepatic steatosis (fat     accumulation in liver cells), either by imaging or by biopsy and absence of causes for     secondary hepatic fat accumulation such as significant alcohol consumption, medications, or     hereditary disorders. In the majority of patients, NAFLD is associated with risk factors for     cardiovascular disease such as obesity, diabetes mellitus, and high cholesterol, and may lead     to irreversible liver damage. Non-alcoholic steatohepatitis (NASH) is a more severe form of     NAFLD and is present in up to 30% of obese adults. NASH is defined by hepatic steatosis and     inflammation with hepatocyte injury with or without fibrosis (hardening of the liver).      The prevalence, morbidity and mortality of NAFLD is increasing, particularly in the     Asia-Pacific region where there will be an estimated 300 million obese people by 2030. Weight     loss is the first-line treatment for NAFLD in obese individuals, but the utility of lifestyle     modification with diet and exercise is limited by difficulties in sustaining compliance and     by eventual weight regain. Bariatric (weight loss) surgery produces the greatest amount of     weight loss but is limited by cost, patient acceptance, and complications. The efficacy of     drugs for NASH, such as vitamin E and medication to lower cholesterol and glucose, remains     unclear. Liraglutide, a glucagon-like peptide (GLP-1) analogue, is an injectable medication     which has been shown to induce weight loss and lower glucose in obese adults. There is little     information on the effects of GLP-1 analogues on NASH, particularly in comparison to other     modalities of weight loss such as surgery. This study aims to compare the efficacy and safety     of lifestyle modification, liraglutide and surgery, for weight loss in conjunction with     reducing severity of NASH, and for insulin resistance, high cholesterol and other     cardiovascular risk factors.   "
48205|NCT02654652|"     The purpose of this study is to determine whether the symbiotic use in patients with head and     neck cancer impact on intestinal function after surgical treatment.   "
48207|NCT02654626|"     This is a randomized, single-blind, placebo-controlled, sequential parallel-group and     multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics     of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before     progressing to the next higher dose.   "
48208|NCT02654613|"     This study addresses the highest ranking health research priority in South Africa, which is,     to develop and test optimal models of HIV-TB service delivery that will enhance retention,     adherence and coverage of HIV-TB co-infected patients. HIV and TB are highest in sub-Saharan     Africa, a region with limited health budgets, infrastructure, human resources, and suboptimal     TB infection control practices. There is compelling clinical evidence suggesting that     integrating HIV and TB services saves lives and presents an effective and efficient use of     resources directed at optimizing health outcomes. Quality improvement (QI) methods are     increasingly being used to systematically test and incorporate local ideas into strategies     for reliable implementation and scale up. This trial is designed to test a practical,     implementable and affordable strategy aimed at improving HIV-TB service integration to reduce     TB and HIV associated deaths. This is a cluster randomized controlled trial, which evaluates     and tests the effectiveness of implementing a QI model to integrate HIV-TB service delivery     in primary health care clinics, on reducing morbidity and mortality in TB-HIV co-infected     patients. This study will be conducted in 2 districts, Ugu and uThungulu, in KwaZulu-Natal,     South Africa. The model of integrated care delivery for TB and HIV using the QI method offers     a systems approach to care delivery to directly enhance treatment outcomes by enabling     comprehensive effective care designed around the patients journey from entry to the clinic,     through screening treatment initiation, treatment completion, and retention in care that is     directed at the goals of cure for TB, effective sustainable HIV viral suppression and reduced     HIV associated TB mortality as the main health impact. The scalability of the model, once     proven effective, is the critical element that makes it increase population coverage of     quality diagnosis and treatment of HIV-TB co-infection. QI methods promote front line staff     engagement in identification and rapid testing of local implementation solutions to gaps in     performance of processes of care along the steps of the patient journey. Gaps in care are     identified through continuous feedback on a core set of indicators collected monthly as     routine collection of data.   "
48209|NCT02654600|"     the decrease in thoracopulmonary compliance after cardiac surgery is well known . The     investigators hypothesize that the major factor determining pulmonary outcome after cardiac     surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that     this alteration is due to CBP itself through pulmonary blood emptying.   "
48210|NCT02654587|"     The aim of this study is to determine if the Investigational Medicinal Product Tedopi     (OSE2101) is more effective than standard treatment in treating patients with stage IIIB     NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.   "
48211|NCT02654574|"     In France, about 1 million people 65 and older are diagnosed with dementia syndrome     characterized by cognitive decline and impairment of functional capacity. The assessment of     the level of functional autonomy is therefore an essential step in monitoring patients in     Memory Clinic and can be estimated by the Lawton IADL questionnaire, assessing the patients'     ability to perform daily tasks.      In the Memory Clinic, the first estimate of the level of patient autonomy is achieved during     a face-to-face interview between their primary caregiver and a nurse, using the IADL     questionnaire. This assessment should be renewed every year. The IADL questionnaire is part     of the information that the memories consultations shall transmit to the Alzheimer's National     Bank (BNA).      However, current practice has shown that the systematic collection is problematic in the     organization of Memory Clinic. It is thus expected to collect this questionnaire by phone in     order to measure changes in the level of autonomy during the disease, and improve the     completeness of this collection. A study is conducted with the main objective to measure the     reliability of the assessment of IADL questionnaires conducted during a telephone interview     with the caregiver of the patient, in comparison to the reference mode: the face-to-face     interview with the caregiver.      Materials and methods The experimental design of the study will be a randomized crossover     trial (crossover), including 394 patients divided into two branches. In the first part, the     collection of the IADL questionnaire will be performed according to the reference method in     the consultation (face-to-face interview with the nurse), the measurement will be repeated at     1 month intervals by phone. In the second part the sequence of execution modes will be     reversed. The reliability of the measurement of the level of autonomy will be studied by     comparing repeated measurements based on handover modes. The correspondence between the     repeated measures will also be considered in terms of patient characteristics. The     feasibility of administration of the questionnaire by phone mode will be evaluated.      Expected results The mode of administration by phone should allow to obtain a reliable     measurement of the level of patient autonomy when the administration is carried out in a     standardized way. The study should also identify patients and situations for which this     method of administration by phone may be appropriate.   "
48212|NCT02654561|"     The primary objective of this study is to estimate the efficacy of unfractionated     heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to     estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association for     Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of UFH in     severe sepsis patients with suspected DIC.   "
48226|NCT02654379|"     This study is to characterize the indications for which rituximab is being used and to     evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for     non-oncology conditions at infusion centers. The study involves the retrospective chart     review of rituximab users' medical records in non-oncology indications as well as a survey to     collect information on participant characteristics, and will include questions about     participant knowledge on the risk of infections, participant receipt and review of the PAC,     and any actions the participant has taken as a result of receiving the PAC.   "
48279|NCT02653677|"     The purposes of the present study are to determine the glycemic and insulinemic responses,     the satiety rate and the postprandial plasma concentrations of free fatty acids,     triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted     bread made with wheat organic flour; handcrafted bread with wheat flour of large-scale retail     distribution; handcrafted bread with organic einkorn flour and a commercial wheat bread.   "
48214|NCT02654535|"     Peanuts and tree nuts (almonds, pistachios, walnuts, pecans, pine nuts, Brazil nuts, cashews,     hazelnuts, macadamia nuts) (herein referred to as nuts) are a good source of unsaturated     fatty acids, vegetable protein, fibre, and polyphenolics. Nut intake has been associated with     reduced cardiovascular disease risk and claims for this association have been permitted by     the FDA; however, intake of tree nuts is low in Canada. One of the barriers to increasing the     consumption of nuts is the perception that they may contribute to weight gain more than other     healthy foods owing to their high energy density. The evidence supporting this concern,     however, is lacking. In a series of earlier systematic reviews and meta-analyses, we have     shown that nuts improve glycemic control and metabolic syndrome criteria, findings which run     contrary to any expected weight gain. However, it remains unclear whether nuts have an     increasing, neutral, or even decreasing effect on body weight. To address the uncertainties,     the investigators propose to conduct a series of systematic reviews and meta-analyses of the     totality of the evidence from controlled trials and prospective cohort studies to investigate     the effect of nut consumption on body weight and adiposity. The findings generated by this     proposed knowledge synthesis will help improve the health of consumers through informing     evidence-based guidelines and improving health outcomes by educating healthcare providers and     patients, stimulating industry innovation, and guiding future research design   "
48215|NCT02654522|"     The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase     (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA) dermal     fillers.   "
48216|NCT02654509|"     This study is being conducted to collect safety and immunogenicity data for the EEE vaccine.   "
48217|NCT02654496|"     The purpose of this study is to investigate mechanisms responsible for weight change in     patients who have undergone weight loss surgery. Specifically, we will compare the gut     microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in     three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal     weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a     control group who has not had a weight loss surgery and are of similar age, gender, body mass     index as the gastric bypass groups.   "
48218|NCT02654483|"     Itch, or pruritus, is the most common complain reported by patients with epidermolysis     bullosa (EB) of all subtypes, and there is no current effective treatment. Itch often     triggers scratching that creates new wounds and increases EB disease severity. This study     aims to target the physiological mechanisms of pruritus. Substance P is a major mediator of     pruritus and binds to the receptor neurokinin-1 (NK1), which is expressed in the central     nervous system and the skin. VPD-737 (serlopitant), a drug that inhibits the NK1 receptor,     has been shown to reduce severe itch in a previous study of 257 adult patients with chronic     pruritus. The investigators are now testing VPD-737 in 14 patients with EB in a Phase II     randomized, placebo-controlled, double-blinded clinical trial. Our goals is to determine     whether daily oral administration of VPD-737 (5 mg) is effective and safe in adolescents and     adults with EB.   "
48219|NCT02654470|"     The WATCHMAN™ Left Atrial Appendage Closure (LAAC) Technology is intended to prevent thrombus     embolization from the left atrial appendage and reduce the risk of life-threatening bleeding     events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation     therapy or who have a contraindication to anticoagulation therapy.   "
48220|NCT02654457|"     The purpose of the study is the identification and semi-quantification of Ki-67 protein     expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual     reading of the same slides.      The imaging system is intended for diagnostic use as an aid to the pathologist in the     detection, counting and classifying ER/PR IHC stained samples   "
48221|NCT02654444|"     The purpose of the study is the identification and quantification of protein expression level     in breast cancer tissues.      The imaging system is intended for diagnostic use as an aid to the pathologist in the     detection, counting and classifying her2 immunohistochemical (IHC) stained samples.   "
48222|NCT02654431|"     The purpose of the study is the identification and quantification of proteins expression     level in breast cancer tissues.      The imaging system is intended for diagnostic use as an aid to the pathologist in the     detection, counting and classifying ER/PR IHC stained samples.   "
48223|NCT02654418|"     SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift     of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to     excision with a snare.   "
48224|NCT02654405|"     The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment     for cognitive deficits in schizophrenia (SZ).      The proposal consists of a small preliminary open label study to assess tolerability and side     effects of sodium butyrate in schizophrenic patients receiving antipsychotic treatment,     followed by a larger double-blind study of the effects of sodium butyrate on cognitive     function and symptoms in SZ patients who are not in an acute exacerbation of the primary     symptoms and show continued cognitive deficits. Secondary aims will be to evaluate its     effects on improving symptoms and functioning in SZ, and the relationship of the drug's     clinical effects to epigenetic and inflammation related biochemical changes.   "
48225|NCT02654392|"     Many studies in the past three decades have examined the beneficial effects of omega-3     polyunsaturated fatty acids in diet and supplementation. The effect of polyunsaturated fatty     acids, specifically omega-3 and omega-6, on health have been well-studied but most of the     study to date has been on animal not plant sources and much less is know about their effects     on exercise performance. Additionally, while positive effects have been detected for     sedentary populations or those that are at risk, well-trained athletes generally have not had     established advantages in taking supplements for omega-3 and omega-6 oils. There is evidence     that a specific ratio of omega-6 to omega-3 is most beneficial for the human body with     regards to cardiovascular and mental health. In this study, participants randomized to either     a plant supplement group (pureform omega; containing Flax, Evening Primrose, Sunflower,     Coconut & Pumpkin oils; Natural Product Number = 80050660) or placebo (isoenergetic sugar     pills) will be subjected to both a time trial and a high intensity interval bout, where their     performance and power output will be analyzed. Blood lactate and glucose concentration, as     well as oxygen consumption and carbon dioxide production will also be examined to determine     if there is a change in on fat oxidation after supplementation.   "
48227|NCT02654366|"     Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies     are often thwarted by strong social networks that reinforce substance use and other risky     injection use and sexual behaviors. The proposed study addresses this important problem by     evaluating the feasibility and efficacy of a novel Community Supported Risk Reduction group.     This structured intervention works with injection drug users and at least one drug-free     family or friend to mobilize social support, teach HIV risk reduction skills, develop     treatment readiness, and support participation in community activities designed to expand     drug-free social networks.   "
48228|NCT02654353|"     This is a prospective randomized controlled trial that compares the conventional stepwise     approach with a new sequential substrate ablation approach for persistent atrial     fibrillation.   "
48229|NCT02654340|"     Association of specific mutations (genotype) after sequencing the TSC1 and TSC2 gene with the     clinical manifestations (phenotype) of the tuberous sclerosis complex in a cohort of     clinically well characterized tuberous sclerosis complex patients. The obtained samples will     be used to establish a tandem-MS-based biomarker.   "
48230|NCT02654327|"     This is a trial of a new way of treating patients with respiratory failure. The investigators     propose to deliver a multi-centre clinical trial to determine whether veno-venous     extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical     ventilation improves outcomes and is cost-effective, in comparison with standard care in     patients who are mechanically ventilated for acute hypoxaemic respiratory failure   "
48231|NCT02654314|"     A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo,     given to patients at least 65 years old, admitted to the hospital on a general medical floor,     to prevent delirium.   "
48232|NCT02654301|"     The present study determined the effect of Xylose consumption on postprandial hyperglycemia     in normal (n=25) and hyperglycemic subjects (n=50).   "
48233|NCT02654288|"     Investigators have previously found that the infiltration of immunoglobulin G4(IgG4) positive     plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative     resection. Investigators further attempt to explore the possible roles of IgG4 and the     inducer of IgG4, interleukin-10(IL-10), in the chemotherapy of pancreatic cancer. In this     primary study, investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in     peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4     and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.   "
48234|NCT02654275|"     Many children and adolescents who engage in swimming complain of shoulder pain during or     after exercise. This pain may worsen and may lead to a decline in performance as well     avoidance of swimming and lastly avoidance of any physical activity whatsoever. The aim of     this study is to determine whether proprioceptive intervention training will effect the power     capacity, proprioceptive ability and technique of young swimmers.   "
48235|NCT02654262|"     Obesity during adolescence, a critical time for bone development, may impair mineral accrual     and reduce bone strength, leading to greater fracture risk during adolescence and later in     life. This study seeks to determine the effect of obesity and accompanying metabolic changes     (insulin resistance and inflammation) on bone mineral accrual and related changes in     structure and strength in young girls. The information is critical to developing effective     prevention strategies to counter the linked risks of obesity and osteoporosis, both major     public health concerns.   "
48236|NCT02654249|"     The study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing     two different strategies in the treatment of grade III and IV hemorrhoids: transanal     hemorrhoidal dearterialization with mucopexy (THD) versus hemorrhoidectomy by Ligasure™.   "
48237|NCT02654236|"     The main purpose of this study is to see whether heavy drinking will interfere with a     specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead     to liver injury in some patients who drink heavily.   "
48238|NCT02654223|"     The purpose of the study is to evaluate the more efficient dose for the treatment of     rhinitis/rhinoconjunctivitis against grass pollen allergy   "
48239|NCT02654210|"     The purpose of this study is to determine in what way infections, microbiome, and     vaccinations during childhood interact in shaping the development of immunity and tolerance.     The investigators collect and use data from a birth cohort focusing on infectious diseases     during childhood and apply a life course perspective.   "
48240|NCT02654197|"     The investigators believe that there is an association between H. pylori infection and     nutritional status and between H. pylori infection and cognitive development. The current     study will examine this association in Israeli children, aged 6-12 years.   "
48241|NCT02654184|"     The quality of induction with sevoflurane, along with its ability to generate optimal     conditions for Laryngeal Mask Airway (LMA) insertion without supplemental opioids or muscle     relaxants, has also been well documented. An ideal inhalation induction technique besides     being rapid and comfortable for the patient should be economical. To achieve rapidity, use of     vital capacity breaths with 8% sevoflurane is a more popular method of induction compared     with the conventional incremental induction.   "
48265|NCT02653872|"     This is a phase 1, non-randomized, fixed sequence, 3-period, drug-drug interaction study to     assess the pharmacokinetics (PK) of AZD7986 in healthy subjects when administered alone and     in combination with multiple doses of verapamil and itraconazole or diltiazem   "
48266|NCT02653859|"     By testing the CTC number of new solitary pulmonary nodule patient, evaluating the     correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the     correlation of CTC number and the size of lung nodules of the malignant patients, the     correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC     and tumor markers will be detected before the patient received treatment. Tumor markers     include Pro-GRP, NSE, CEA, CYFRA211, SCC.   "
48244|NCT02654145|"     Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and     reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE)     monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic     asthma. The aim of this study is to investigate whether subjects not optimally controlled on     their current omalizumab treatment, who are eligible for therapy with mepolizumab can be     effectively and safely switched to treatment with mepolizumab to improve asthma control. The     study will provide data on the efficacy, safety, immunogenicity, and tolerability of     mepolizumab when switched directly from omalizumab without any wash-out. The learnings from     this study may help guide physicians when substituting one biologic with another for the     treatment of patients with severe eosinophilic asthma.      The study will be a multi-centre, open-label single arm trial. Patients with severe     eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be     eligible to participate. Subjects will remain on their current maintenance therapy including     omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit     2 (week 0) subjects will discontinue their omalizumab treatment and be switched to     mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32     weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last     dose of mepolizumab.   "
48245|NCT02654132|"     The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose     dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma     compared to pomalidomide and low-dose dexamethasone by itself.   "
48246|NCT02654119|"     This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and     trastuzumab work when given after surgery in treating patients with stage I-II human     epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or     the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as     cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of     tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel and trastuzumab after     surgery may help prevent the cancer from coming back.   "
48247|NCT02654106|"     This clinical trial was designed to investigate the efficiency and toxicity of fractionated     stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain     metastases.   "
48248|NCT02654093|"     The purpose of this study is to learn about the effect of raloxifene on how the body absorbs     and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken     together.   "
48249|NCT02654080|"     The purpose of this study is to evaluate the safety and tolerability of an HIV-1 nef/tat/vif,     env pDNA vaccine delivered with electroporation (EP), followed by a recombinant vesicular     stomatitis virus (rVSV) HIV envC vaccine boost, in healthy, HIV-uninfected adults.   "
48250|NCT02654067|"     Pregnant patients mallampati class scores will be examined throughout pregnancy   "
48251|NCT02654054|"     This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in     combination with estradiol/norethindrone acetate for the management of heavy menstrual     bleeding associated with uterine fibroids in premenopausal women.   "
48252|NCT02654041|"     The objective of the study is to assess the safety and efficacy of treatment with     hypothyroxinemia adjunct to conventional therapies in GBM patients.   "
48253|NCT02654028|"     This prospective study aims to determine whether autotransfusion of red blood cells salvaged     during liver resection is associated with the recurrence of hepatocellular carcinoma.   "
48254|NCT02654015|"     The primary objective of this multicenter single arm feasibility study is to provide an     assessment of enrollment and follow up feasibility for this patient population being treated     with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for     the INVEST Feasibility Study will be referred to the INVEST Registry study.   "
48255|NCT02654002|"     This study will evaluate the safety and tolerability of escalating single- and multiple-oral     doses of GS-9674, and characterize the single- and multiple-dose pharmacokinetics (PK) of     GS-9674. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants     will receive either GS-9674 or GS-9674 placebo.      Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,     blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to     multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or     pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily     doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will     consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated     in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose     already evaluated.      This study is partially blinded (no one is blinded on Day -1).   "
48256|NCT02653989|"     The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with     relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable     disease or a partial remission following definitive salvage therapy.      Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but     considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients     who have received ASCT following salvage chemotherapy.   "
48257|NCT02653976|"     This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized     study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory     patients with peripheral T-cell lymphoma.   "
48277|NCT02653716|"     To evaluate the clinical and cost-effectiveness of the New Orleans Intervention Method (NIM)     in relation to an enhanced services as usual model, Case Management (CM), for the management     of maltreated infants and young children entering care in the United Kingdom (UK) .   "
48278|NCT02653703|"     The aim of this study is to quantitatively characterize the effects of L-menthol as a topical     counter-irritant on cutaneous pain and hyperalgesia provoked by topical application of the     TRPA1-agonist trans-cinnamaldehyde (CA) in healthy human volunteers.   "
48303|NCT02653365|"     The aims of our study was to identify early predictors of non-invasive ventilation failure,     so as to alert clinicians early that endotracheal intubation and mechanical ventilation might     be appropriate.   "
48258|NCT02653963|"     This triple-blind, stratified, randomized clinical trial includes 100 eyes of 100 patients     aged 18 to 85 years with refractory glaucoma. Eligible subjects undergo stratified block     randomization; eyes are first stratified to one of four subgroups: group 1:patients with     previous failed trabeculectomy, group 2: uveitic glaucoma, group 3: neovascular glaucoma and     group 4: other indications like aphakic glaucoma or glaucoma associated with vitreoretinal     procedures.      In each subgroup, eyes are randomly assigned to the study arms using random blocks:     conventional Ahmed Glaucoma Valve (AGV) implantation (group A, 50 eyes), Ahmed Glaucoma Valve     (AGV) with intraoperative periplate triamcinolone injection (group B, 50 eyes).      Patients will be followed for one year. They will undergo full ophthalmology examination at     first day, first week, month 1, 3, 6, 9 and 12 after the surgery.      The primary outcome measure is cumulative probability of success, defined as intraocular     pressure (IOP) of 6-21 mm Hg, with or without medication, and no serious complications,     additional glaucoma surgery, or loss of light perception.      The outcomes will be compared between two arms in each subgroup.      The number of eyes requiring medications, time to initiation of medications, and number of     medications will be compared.   "
48259|NCT02653950|"     In this study the investigators aim to assess whether endoscopic septoplasty is effective at     improving patients QOL and reducing postoperative signs and complications.      Primary outcome: To assess the differences in overall QOL between endoscopic and traditional     septoplasty after adjusting for pertinent confounding variables.      Secondary outcomes:        1. To evaluate the post-operative complication rate in patients undergoing endoscopic          septoplasty compared to traditional.        2. To evaluate the differences in the operation time between the two different approaches.   "
48260|NCT02653937|"     Abstract      Background & Aims:      Abdominal N line tenderness for diagnosis and shigyakusan for treatment of irritable bowel     syndrome ( IBS ) and medically unexplained physical symptoms ( MUPS ) were studied.      K1 is point of one quarters of distance from center of navel to right anterior superior iliac     spine. K2 is one quarters of distance from center of navel to upside of the symphysis pubis.     K3 is center of line from xiphoid process to navel. There are three relevant lines; K1-K3     line, K2-K3 line, and line of identical length to K1-K3 line originating from K2 and running     parallel to K1-K3 line. Author collectively named these 'N line'. There was not the study     under author's investigation that effects of shigyakusan and other medicines were compared.     Author confirmed existence of mild IBS, for whose patients existing largely, various     expensive examinations are spent.      Method:      The author put pressure on N line by deep palpitation and judged of abdominal N line     tenderness positive or negative.      Shigyakusan, a Kampo medicine, was administered to each of N line positive patients, of IBS     by Rome III, of no IBS by Rome III, and of MUPS. The change of symptoms of IBS and MUPS by     shigyakusan was showed with an arrow by self-declaration.      Conclusions:      Shigyakusan was more effective for IBS than previous medicines. IBS was diagnosed by Rome III     and N line tenderness and author confirmed the existence of mild IBS which was diagnosed by N     line tenderness with help of RomeIII. MUPS showed N line tenderness though patients     complained of no abdominal symptoms. Shigyakusan was very effective for IBS, mild IBS and     MUPS.   "
48261|NCT02653924|"     The final stage of any surgical procedure is suturing. Sutures have a vital rule in wound     healing- they are responsible for flaps approximation, hemostasis and restoring function and     esthetics.      Choosing the right suture is crucial especially in oral sites because of its unique     anatomical features: the presence of saliva and the patient's everyday function- swallowing,     talking, eating etc.      Sutures require certain physical properties such as tensile strength, dimensional stability,     lack of memory, knot security and elasticity. One highly important quality is the ability to     prevent or reduce bacterial adhesion and by that to prevent secondary infection. There are     many kinds of sutures in the market- none of which contains all the ideal features.      The aim of the study is to compare the amount of bacterial adhesion to different kinds of     sutures in patients undergoing periodontal surgery.   "
48262|NCT02653911|"     Polycystic ovary syndrome (PCOS) is a dysfunction of endocrine system of women of     reproductive age. Approximately 5%-10% women in China have this syndrome. Irregular     menstruation (oligomenorrhea or amenorrhea), hirsutism and obesity are the common clinical     manifestations of PCOS. The aim of this study is to determine whether electroacupuncture     normalizes hormonal and glycometabolic profiles in women with polycystic ovary syndrome when     compared with placebo-needle.   "
48273|NCT02653768|"     Knee osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of     disability among Veterans. Although exercise is known to improve pain, physical abilities,     and other outcomes for patients who have knee OA, most individuals with this condition are     physically inactive. Therefore there is a need to develop programs that will help Veterans     and others with knee OA to increase activity levels. This study will examine a stepped     approach to helping Veterans with knee OA to increase physical activity, with increasing     levels of program intensity when needed for individual patients to meaningfully improve pain     and physical function.   "
48274|NCT02653755|"     This research study is a way of gaining new knowledge about whether patients can omit     radiation treatment after undergoing a lumpectomy, also known as breast conserving surgery.     In this trial, we are attempting to identify which patients may not need radiation.   "
48275|NCT02653742|"     The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with     fentanyl intranasal used in our hospital for pain control in children undergoing bilateral     myringotomy with placement of pressure equalization tubes (BMTs).   "
48263|NCT02653898|"     Antimalarial drug resistance has reached critical levels on the Thai-Cambodian border. Many     have begun advocating for concerted malaria elimination efforts in Cambodia. However, there     is currently no consensus on how malaria elimination is to be achieved with the tools     available.      In this study, the investigators will conduct operational research with the Royal Cambodian     Armed Forces (RCAF) and National Malaria Center (CNM) to quantify the relative effectiveness     of the two major interventional approaches - monthly malaria prophylaxis (MMP) or focused     screening and treatment (FSAT) - in a head to-head comparison. In addition, the investigators     will quantify the relative contribution of a recently advocated vector intervention for     military personnel - the insecticide treated uniform (ITU) - in addition to other vector     control measures currently employed by the RCAF. The investigators will employ the same     permethrin insecticide self-application kits currently used by the US military. The     investigators will estimate the cost effectiveness of each approach and attempt to define the     best way forward for malaria elimination efforts in a critically important malaria reservoir     in military population (and their dependents) who reside on the Thai-Cambodian border. The     aim of the study is not only to conduct research to better define the best way forward in     malaria elimination efforts in the high risk military populations, but to also build capacity     within the RCAF to support and lead future elimination efforts in the most difficult-to-reach     mobile populations.   "
48264|NCT02653885|"     The outcome predictors for cardiac surgery has been popular for many researchers and     clinicians. Determining risk factors before surgery reduce morbidity and mortality after     surgery. Some routine blood results have been used as predictors for cardiac surgery but none     of the researches studied red cell distribution width, mean platelet volume,     platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these     parameters and to see whether these parameters can be predictors for cardiac surgery.   "
48304|NCT02653352|"     The purpose of this study was to encourage students to reduce soft drinks intake,     substituting it by water, in order to prevent and control overweight prevalence.   "
48267|NCT02653846|"     Portal hypertension (PH) results from the increase of portal flow resistance in fibrotic     tissue of the liver in patients with chronic liver diseases, leading to complications such as     varices formation and variceal bleeding, ascites formation, spleenomegaly and     hypersplenismus, systemic haemodynamic disorders and porto-systemic shunts formation. Early     detection of PH in patients with chronic liver diseases is clinically important as it should     change patient management in order to prevent the formation/onset or recurrence of PH     complications. Hepatic venous pressure gradient (HVPG) measurement is the gold standard for     the assessment of the severity of PH. However, it is an invasive method with its risks, and     relatively costly. On the other hand transient elastography (TE) emerged as a non-invasive,     easy, safe and low cost method with the potential to assess the severity of PH, as liver     stiffness (LS) and spleen stiffens (SS) measured by TE showed very good correlation with     HVPG. Real-time 2D shear wave elastography (RT-2D-SWE) is an ultrasound elastography method     reliable for non-invasive assessment of fibrosis stage especially in chronic viral hepatitis,     but only preliminary data exist on the correlation of RT-2D-SWE measured LS/SS with and HVPG.     In this study we hypothesized that LS and SS measured by RT-2D-SWE correlate with HVPG     enabling RT-2D-SWE to be used for the assessment of severity of PH. The primary aim of this     study is to analyse correlation between LS and SS as assessed by RT-2D-SWE and TE with the     grade of portal hypertension as assessed by HVPG. The secondary aims are: 1) to analyse     clinical outcomes of these patients in order to determine if LS and/or SS as assessed by     RT-2D-SWE might predict adverse outcomes (liver decompensation, death or HCC development),     and 2) to compare clinical performance (AUC) of RT-2D-SWE and TE for the assessment of the PH     severity as well as for predicting clinical outcomes. Patients with suspicion of having     compensated advanced chronic liver disease (cACLD) as assesed by non-invasive methods     (transabdominal ultrasound, laboratory findings, FIB-4 and APRI score, and LS measurements by     TE), will be included. Since positive predictive value of non-invasive methods for cirrhosis     is generally not very reliable, these patients will be offered transjugular liver biopsy and     HVPG measurements as gold-standard methods to define the stage of liver disease and severity     of PH. These patients will undergo LS and SS measurements by RT-2D-SWE on Aixplorer     SuperSonic Imagine ultrasound system and HVPG measurements as well, with transjugular liver     biopsy performed during the same session. After SWE™ and HVPG measurement, 5-year follow-up     is planned, including standard surveillance: laboratory findings, transabdominal US every six     months and upper-GI endoscopy according to relevant guidelines, as well as treatment     according to relevant guidelines as indicated: beta blockers, endoscopic variceal ligation,     etiologic treatment and dietary measures. Appropriate statistical analysis will be undertaken     after the enrollment period, as well as after follow-up period.   "
48268|NCT02653833|"     This pilot study tests the hypothesis that the medication nitric oxide extract from beetroot     juice improves blood flow to the skeletal muscle during exercise. The investigators will use     cutting edge technology with contrast enhanced ultrasound to visualize the microvascular     blood supply to the forearm. Animal studies have shown reversal of muscle damage with     improved delivery of blood to the exercising muscle. This research aims to understand the     mechanism of action of this medication in a way it has never been studied before. The results     may help benefit individuals with muscular Dystrophy in the future.   "
48269|NCT02653820|"     Reflexology treatment may influence the severity of chemotherapy-induced nausea and vomiting.     This study aims to investigate the clinical effect of reflexology on chemotherapy-induced     nausea and vomiting.   "
48270|NCT02653807|"     Ankle rigidity is a common musculoskeletal disorder affecting the talocrural joint, which can     impair weight-bearing ankle dorsiflexion (WBADF). The objective was to compare the efficacy     of Mulligan Mobilization with Movement (MWM) and Osteopathic Mobilization (OM) for improving     ankle dorsiflexion range of motion (ROM) and musculoarticular stiffness (MAS).   "
48271|NCT02653794|"     It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life     for macular region to develop from structural formation to functional integrity. However,     children are still in the critical period of plastic visual development, for their visual     acuity has not yet reached the level of adults. Similarly macular retinal structure may     develop with age. It is very important to study in macular thickness of this period and to     have a proper cognition of it and the relation between macular thickness and other ocular     parameter for the research of retinal development and diseases and the early screen of fundus     diseases.   "
48272|NCT02653781|"     Realistic simulation is an effective teaching strategy for the acquisition and retention of     knowledge and increased self-confidence of students, which contribute to safety in performing     nursing actions.Considering the need to adopt safe practices in health since professional     training, there are deficiencies in health teaching and weaknesses in the acquisition of     practical skills guided by safety principles and critical clinical reasoning. The purpose is     to compare the use of high fidelity simulation with traditional education as innovative     method in the process of teaching and learning. This is a prospective, randomized, controlled     and single-blind study, of pre-test and post-test experimental type, with application of high     fidelity simulation in the theme of patient safety in administration of parenteral drugs.   "
48360|NCT02652611|"     Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can     have a major affect on a patient's quality of life. Persistent pain after radiographic     evidence of fracture union commonly leads to implant removal. But, the routine removal of     orthopaedic fixation devices after fracture healing remains an issue of debate.   "
48276|NCT02653729|"     This study aims to examine the effectiveness of cognitive behavior therapy for psychosis in     first episode patients and see the outcome of CBT on psychotic symptoms. Because cognitive     behavior therapy mostly use in depressive patient to treat the negative thinking pattern     Cognitive behavioral approaches in the treatment of psychosis have become more prevalent in     recent years for a number of reasons. Evidence has been available for the past two or three     decades regarding the success of these techniques with other forms of psychopathology such as     depression, anxiety disorders, and medical problems. Anxiety, depression and low self-esteem     have been cited as the most common consequences of psychotic disorders. The observation has     also emerged that many patients develop their own coping strategies for reducing the     frequency, severity, and disruptiveness of their symptoms. There has also been increasing     evidence regarding the influence of social environmental factors on the course of psychosis     and the development of stress-vulnerability models to explain these relationships. Research     suggests that 20 to 50 percent of persons with psychosis who receive neuroleptics continue to     experience difficulties related to their psychotic symptoms.   "
48374|NCT02652429|"     An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial     Hypertension (PAH)   "
48280|NCT02653664|"     Chronic pain is a significant problem for many Veterans, including new Veterans returning     from Iraq and Afghanistan. It is also associated with a number of other significant problems,     such as post-traumatic stress disorder and sleep problems. All of these can have significant     negative effects of the quality of life of Veterans      Three different types of treatment that have been used to treat chronic pain in the general     population include self-hypnosis, education about chronic pain, and teaching individuals how     to be more mindful. The purpose of this study is to see if these three treatments can help     decrease pain in Veterans. Additionally, the researchers want to determine if each of these     treatments can help reduce the negative consequences associated with pain, such as changes in     mood, sleep, and enjoyment of life.      Different types of treatment that include self-hypnosis, education about chronic pain, and     learning skills on how to change how a person perceives his/her pain have been used to treat     chronic pain the general population.      The purpose of this study of this study is to see if these different treatments can help     decrease pain and improve quality of life in Veterans with chronic pain, and determine how     and why these treatments are effective. A subject must have a Veteran status, have chronic     pain, speak English and be at least 18 years old to participate.      Sleep Sub-Study      Chronic pain and sleep problems are common among Veterans. Study researchers believe the     treatment interventions provided as part of the main study will help improve pain and sleep.     However, the main study does not include a real time measurement of sleep nor does it     include any specific strategies for examining the relationship between sleep and pain.      Previous research has shown that adequate sleep has been linked to improvements in pain     reports. Adversely, sleep deprivation has been found to increase pain perception since it     decreases a person's ability to disengage from pain. Therefore, the purpose of this sub-study     is to measure sleep in order to learn more about how it interacts with chronic pain.      All of the subjects in this sub-study will be Veterans recruited from VA Puget Sound who     experience moderate-to-severe chronic pain on a regular basis and who have enrolled in the     main study. Study investigators will enroll up to 135 subjects into the sub-study.   "
48281|NCT02653651|"     Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain     after surgery remains a significant clinical problem as it impairs recovery adversely and may     lead to the transition to chronic pain. The open approach represents a major physical trauma     including postoperative pain and discomfort in the convalescence period. Adequate control of     postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled     analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic     analgesia and may also elicit side effects that may delay hospital discharge. Preventing     early and late postsurgical pain is an important challenge for anesthesiologists and     surgeons.      Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker)     are popular analgesic adjuvants for improving perioperative pain management. The     investigators designed this double-blind, placebo controlled study to test and compare the     preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic     pain after elective open nephrectomy.      The investigators propose a double-blind placebo-controlled study of patients undergoing     elective open nephrectomy. All patients will receive normal patient-controlled analgesia     morphine in addition to study drugs or placebo. Research will be conducted at Charles     Nicolle teaching hospital.   "
48282|NCT02653638|"     Cerebral vasodilator responses to CO2 will be measured in young healthy adults, healthy     sedentary older adults, and healthy exercise trained older adults. This variable will be     examined before and after administering the cyclooxygenase inhibitor indomethacin, which has     been shown to blunt cerebral vasodilator responses. In addition, the investigators will     examine these counter-regulatory hemodynamic mechanisms to hypoperfusion caused by     indomethacin.   "
48283|NCT02653625|"     This is a single-arm, open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult     subjects with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is     to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24     weeks of treatment with CVC.   "
48284|NCT02653612|"     The goal is to improve surgery by preventing tumor cells from being left behind at the time     of surgery. This includes finding residual tumor cells in the wound after surgery.   "
48285|NCT02653599|"     This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group,     Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to     evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight     following administration for 3 months.   "
48286|NCT02653586|"     The study was a group randomized controlled trial. Within each school Classes of high school     students were allocated by randomization to the intervention or control group by a function     Randomization in Excel program. Outcomes were measured by questionnaire at pre- intervention,     post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai college     institutional review board. Parents of all participants, in the intervention and in the     control group, received information about the program and the study and were choose whether     to provided informed consent or not.   "
48287|NCT02653573|"     This study was designed to evaluate the feasibility of a telephone-based health coach     self-management intervention for young adults.   "
48288|NCT02653560|"     In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits,     vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in     controlling hypertension. Key components of such a diet are potassium, magnesium and alkali,     each of which has been implicated in lowering blood pressure. Whether a liquid formulation of     potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.   "
48289|NCT02653547|"     Patients receive two weeks of treatment (prefrontal high-frequency and bilateral     low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After     two weeks of treatment they can decide if they want to quit the treatment or if they want to     proceed with the treatment for another two weeks.   "
48290|NCT02653534|"     This study is being conducted to assess the impact of promoting community initiated Kangaroo     Mother Care (KMC) for low birth weight babies on post enrolment neonatal mortality and     mortality post enrolment upto 6 months of age. This large individually randomized controlled     trial will enroll 10500 low birth weight babies. The secondary objectives are examining the     impact of the intervention on exclusive breast feeding and growth at 1 and 3 months,     infections and hospitalizations in the neonatal period and from 1 to 5 months of age,     recognition of illnesses and early care seeking from appropriate sources, motor and mental     development in a subsample.      Newborns weighing >=1500 to <=2250gm are being enrolled into the study within 3 days of     birth. Eligible babies are randomized to intervention or control arms. Mothers in the     intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse     Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home     visits are conducted in both intervention and control arms by government workers according to     the existing government program.      Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.   "
48291|NCT02653521|"     The purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive     radiation therapy, ART) for esophageal cancer, using dose tracking technique with online     images and deformable registration.   "
48292|NCT02653508|"     The Feeding-Exercise Trial in Adolescents (FETA) was a randomised controlled intervention     study designed to promote healthy weight in overweigh and obese adolescents through a     professional-delivered, community-based program with active parents' involvement, focused on     supervised physical activity and structured nutritional education. The aim of FETA was to     test the efficacy of two intervention groups- physical activity in isolation and combination     of physical activity with provision of dietary information- for improving overweight and     obesity in adolescents. Our primary hypothesis was that a combined program would be more     efficacious than activity in isolation and that activity alone would also be effective     compared to control group in improving adiposity profiles in overweight and obese adolescents     as well as family activity and feeding habits.   "
48293|NCT02653495|"     Metabolic syndrome (MetS) is a cluster of metabolic conditions associated with obesity that     predispose individuals to coronary heart diseases and diabetes but obesity has been shown to     increase the risks of other diseases like cancer and asthma. Studies have also shown that     obesity increases the risk of severe influenza infection and associated death and reduces the     efficacy of influenza vaccine in the obese population but yet, the molecular mechanisms have     not been described. The investigators are thus hypothesizing that differences in the innate     immune responses between individual with or without metabolic syndrome impact viral infection     and vaccine outcome. The investigators will perform seasonal influenza vaccination in people     with or without metabolic syndrome to determine if the late adaptive response assessed by     antibodies titers is different between the two groups and correlates with the early immune     response assessed by gene expression profile in whole blood cells. The project proposed by     the investigators will contribute to a better understanding of the inflammatory phenotype     associated with metabolic syndrome and establish for the first time if it affects the immune     protection against infectious diseases and particularly against influenza virus infection.     The results will be important to determine if the population affected by metabolic syndrome     should receive anti-influenza treatment in priority in the context of a severe influenza     epidemic.   "
48294|NCT02653482|"     The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared     with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and     quality of life in patients with type 2 diabetes and chronic heart failure with reduced     systolic function.   "
48295|NCT02653469|"     Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator     based on heart-lung interaction to predict fluid responsiveness. Generally, patients are     considered to be fluid-responsive when the PPV value larger than 11-13%. However, several     previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To     predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%),     the investigators would evaluate the augmented PPV using augmented ventilation.   "
48296|NCT02653456|"     The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the     treatment of patients with lower extremity vascular disease with chronic total occlusions.   "
48297|NCT02653443|"     The objective of this study is to test the hypothesis that INTERCEPT Blood System for     platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain     sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of     autologous INTERCEPT Blood System for platelet components in 35% plasma/65% InterSol (Test     platelets) stored for 6 or 7 days will be measured in comparison to fresh autologous     radiolabeled platelets (Control platelets) according to FDA guidance for platelet testing     (FDA 1999). Recovery and lifespan results between components stored for 6 and 7 days will     also be assessed.   "
48298|NCT02653430|"     This is a long-term follow-up and interventional study in individuals who have been diagnosed     with moderate to severe obesity with or without diabetes. The purpose of this study is to     determine the effects of sleeve gastrectomy on weight and blood sugar control and underlying     mechanisms by metabolomics, metagenomics, functional magnetic resonance imaging (fMRI)     ,adipose tissue expression chip and etc.   "
48299|NCT02653417|"     The purpose of this study is to determine the clinical safety of and whether RAD1901 reduces     the frequency and severity of VMS in postmenopausal women regardless of uterine status.   "
48353|NCT02652702|"     Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There     are significant variations in the outcome of surgery due to differences in the suture     techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and     efficient colostomy than the conventional methods.But all those reports are single center     retrospective cohort study，no randomized controlled trials have been carried out so far.The     aim of this study is to comparing the safety and efficiency of circular stapler-assisted     colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.   "
48361|NCT02652598|"     The experimental design is an open-label two-week trial of tolcapone to evaluate which     clinical domains are affected by tolcapone treatment and to identify responders to     tolcapone treatment in the two subject groups (BI and NCD)   "
48300|NCT02653404|"     The aim of this project is to analyze the potential contribution of IGRA test QuantiFERON-TB     Gold In Tube test (QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in the     diagnosis of tuberculosis (TB - active or latent) in pediatric subjects (0 and 17 year)s     recently exposed to infection (indicated as contacts) or with clinical suspicion of active     TB, and to compare the results obtained with those of the TuberculinSkin Test (TST; gold     standard). The project is expected to enroll up to 50 pediatric patients over a 4-year study.     Children with access to Ambulatory structures or hospitalized at University Infectious     Diseases Clinic or Pediatric Clinic, University Hospital of Siena, or with access to     Ambulatory or hospitalized at Pediatric Clinic USL 9 Grosseto will be enrolled. Once obtained     the informed consent of patients' parents or legal guardians, patients will be enrolled. The     doctor will administer a clinical-anamnestic questionnaire, relative to the country of birth     and residence, date of arrival in Italy and any stays in the country of origin (in case of     foreign patient), travels abroad, risk factors for infectious diseases, type of contact with     any index case, previous vaccination with BCG, date and outcome of the TST, clinical symptoms     and signs suggestive of active TB, report of any instrumental investigation. Together with     the collection of blood samples for routine purposes, an additional blood sample will be     taken so to run IGRA test. Also patients for whom their medical doctor will independently     order to run QTF-GIT test as necessary tool for the clinical diagnosis of TB will be included     in the study.      A retrospective analysis will be performed on patient pertaining to participant Clinics, from     1 January 2012 to 31 May 2015. Such analysis will be performed on those patients for which     their medical doctor requested both intradermal Mantoux and IGRA test.      Expected results:        -  estimation of concordance between QuantiFERON-TB Gold In Tube and TST in pediatric          patients exposed to TB, with or without latent TB infection        -  Evaluation of the sensitivity of the test QTF-GIT in patients with active tuberculosis          disease        -  Evaluation of specificity of testQTF-GIT in not infected patients        -  Evaluation on the possible use of QTF-GIT, together with TST, to improve the diagnosis          of tuberculosis latent or active infection in pediatric subjects.        -  Evaluation of the possible diagnostic use of QTF-GIT in the child <5 years.   "
48301|NCT02653391|"     This is a Phase 1/2 trial in two parts. Part A is a prospective, randomized, double-masked,     vehicle controlled, paired-eye study in approximately 16 subjects to evaluate safety,     tolerability and efficacy of elamipretide 1.0% topical ophthalmic solution in patients with     FCED presenting with mild to moderate corneal edema. Part B is a prospective, randomized     double-masked, vehicle controlled study in approximately 11 subjects to evaluate safety,     tolerability, and efficacy of elamipretide 3.0% topical ophthalmic solution in patients with     FCED presenting with mild to moderate corneal edema.   "
48302|NCT02653378|"     The purpose of this study is to determine how the modality of energy depletion can     differently impact appetite hormones, ad libitum food intake, food hedonics, and olfaction.   "
48305|NCT02653339|"     This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi     Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix     sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on     treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from     Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result     of the self and between-group cross-reference by two questionnaires filled before and after     treatment.   "
48306|NCT02653326|"     In this randomised, double-blind, pilot study, the investigators aim to assess whether a     telerehabilitation strategy could improve outcomes among patients with recent heart surgery.     Included participants will receive a comprehensive rehabilitation programme comprised of     physical therapy, nutritional counselling, psychological assistance in addition to standard     medical care. After 12 sessions of physical therapy, patients will be randomised to receive     telerehabilitation with a portable EKG device and a smartphone application or usual care. The     primary endpoint for this study is the exercise capacity of included participants, which will     be assessed using an ergospirometer at 4 and 8 weeks after randomisation.   "
48307|NCT02653313|"     Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects     suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.   "
48308|NCT02653300|"     This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with     NASH and confirmed type 2 DM or pre-diabetes. The study will consist of a Screening, placebo     run-in, treatment phase and end-of-study phase.   "
48309|NCT02653287|"     Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will     be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons     with systemic lupus erythematosus (SLE). The intervention group will receive individual     coaching and group educational sessions focusing on physical activity and nutrition while the     control group will receive individual calls in relation to SLE self-management group     educational sessions.This study is designed to evaluate the LIFT intervention to decrease     fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior     (exploratory outcome) in persons with SLE.   "
48310|NCT02653274|"     Breakfast porridges are made from milled grains and are commonly eaten worldwide.     Traditionally different grains are used in different countries. For example, oats are more     common in the Anglo-Saxon countries; rye is favoured in the Scandinavian countries whilst     millet is very common in parts of India and Africa. However the nutritional value and     potential metabolic and health effects may vary dramatically between different grains. For     example what is the effect of the different grains on blood sugar or on how fast the stomach     empties after eating the porridge and how full people feel. All these physiological responses     may differ between these grains resulting in potential health benefits.      RESEARCH QUESTION: The investigators hypothesise that porridges made from different grains     will behave differently during the digestion and cause differences in blood glucose levels,     gastric emptying and appetite.      This study, which is a 4-way, randomized, cross over pilot study in healthy participants,     aims to answer this research question.      The participants will be asked to eat a porridge breakfasts made with oats, rye and millet of     different varieties (but containing the same amount of calories), in 4 morning studies one     week apart. MRI will be used to monitor the gastrointestinal fate of the breakfasts and     measure gastric emptying using MRI, blood glucose levels using a finger prick test and     self-reported appetite scores.   "
48354|NCT02652689|"     The LDS may contain information of significant diagnostic and physiological value regarding     the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general.     In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well     as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions were     identified. We believe that these newly discovered ultrasound signals might provide a     non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism.      The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler     signals performed via transthoracic parametric Doppler. The objective of the study is to     evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to     determine the potential assessment value of this non-invasive method in this potentially life     threatening condition.   "
48311|NCT02653261|"     Transurethral resection of the prostate (TURP) represents the gold standard in the operative     management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder     tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most     important complications of urological endoscopic resections is intraoperative and     postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free     of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury,     fluid overload, increased costs and hospital length of stay.      Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by     blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been     used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery     and orthopedic surgical procedures but few studies have assessed the efficacy of this     antifibrinolytic agent in urological endoscopic procedures.      The investigators designed this double-blind, placebo controlled study evaluate the safety     and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in     patients undergoing endoscopic surgery in urology.   "
48312|NCT02653248|"     Stereotactic Body Radiation Therapy (SBRT) is a method of delivering radiation which can     target the tumor more precisely and cause less damage to normal tissue. This is a Phase I     research study looking at the safety of the dose of SBRT in organ confined prostate cancer.   "
48313|NCT02653235|"     Acquiring, processing and utilising information is crucial to any mental function     -including seemingly simple daily functions. Collectively called 'cognitive functions', these     processes are a result of different regions of the brain acting together.      Disruption of these cognitive functions increases the risk of development of mental health     problem. Recently it has been proposed that inflammatory pathways may contribute to disorders     of cognition and behaviour like depression.      This is largely due to research showing that those with inflammatory conditions like     arthritis are more likely to develop mental health problems like depression. Conversely,     those who suffer from mental health problems (even in the absence of inflammatory conditions)     have large amounts of inflammatory molecules in the blood. Studies in animals suggest that     inflammation outside the brain can reach and affect the brain in a number of ways. So, does     inflammation play a role in the development of cognitive and behavioural symptoms? What are     the pathways involved?      The current project tries to address this question. Specifically, the investigators intend to     use modern scanning techniques to examine the effect of inducing a low grade inflammation     (using a commonly used typhoid vaccine) to see how the inflammation affects how different     regions of the act together to perform cognitive functions.   "
48375|NCT02652416|"     Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following     oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)   "
48314|NCT02653222|"     In this study the investigators are going to assess the feasibility of this innovate     technique of renal sympathetic denervation by translumbar access under ct-guidance.      To limit the potential impact on the kidney, the investigators chose a population of chronic     renal failure patients on dialysis or renal transplant (with native kidneys still present)     and having resistant treatment hypertension despite antihypertensive combination therapy well     conducted.      The investigators expect to obtain a decrease of the blood pressure at the 24-hours     ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.   "
48315|NCT02653209|"     The aim of this project is to identify subgroups of patients with type 2 diabetes that     respond well or poorly to particular drugs based on particular clinical characteristics such     as their weight or kidney function, to enable better targeting of treatment for a particular     individual.      This study will test 2 hypotheses of drug response supported by routine clinical and trial     data. 600 patients with type 2 diabetes who have suboptimal glycaemic control on dual oral     therapy will be recruited to a randomised double-blind crossover study of a DPP4 inhibitor,     SGLT2 inhibitor and thiazolidinedione. Each patient will take each study drug in addition to     their existing treatment for four months at a time. At the end of each treatment the     patient's glucose control will be measured and information about their experience of the drug     will be collected.   "
48316|NCT02653196|"     There is currently no standard treatment for patients with neuro-epithelial (brain) or other     solid tumors in another part of the body who do not have adequate suitable autologous     hematopoietic progenitor cells available and/or whose disease has relapsed after standard     treatment. Allogeneic Hematopoietic Progenitor Cell Transplant may be a consideration for     treatment of patients with recurrent chemo-responsive malignant (high grade) neuro-epithelial     and other solid tumors or those who do not have suitable autologous hematopoietic progenitor     cell availability. The procedure in which your own blood stem cells are transplanted to you     is called an autologous (from your own) progenitor cell transplant and when cells from a     matched donor are transfused is called an allogeneic progenitor cell transplant. The study is     being conducted to evaluate the safety and effectiveness of a combination of drugs followed     by an allogeneic hematopoietic progenitor cell transplant (HPCT). This treatment regimen is     experimental in that although the individual drugs are commonly used to treat your disease,     the specific combination used in this protocol followed by the transplant is experimental.   "
48317|NCT02653183|"     The primary objective of this investigation is to evaluate if complications related to     surgical wound are more common in the treatment group compared to the control group starting     from operation day until last visit.      The secondary objectives are to evaluate:        -  the performance of the dressing        -  the comfort, conformability and the acceptability of the dressing        -  pain before and during dressing removal on the last visit   "
48355|NCT02652676|"     The purpose of this study is to: 1) Remodel and restore left ventricular geometry and     function. 2) Avoid the need for mechanical circulatory support (MCS) and/or cardiac     transplantation (CT). 3) Confirm the outcomes of a pilot study completed in Germany and     reported in The Journal of Heart and Lung Transplantation in May 2013.   "
48359|NCT02652624|"     This study will evaluate the efficacy of switching to a fixed-dose combination (FDC) of     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen     consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF),     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or     atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in     virologically suppressed HIV-1 infected women.   "
48318|NCT02653170|"     The Michigan Stroke Transitions Trial (MISTT) is a patient-centered randomized control trial     that aims to improve the experience of stroke patients after they return home. The MISTT     study will test the effect of two complementary interventions against usual care. The two     interventions include: a) Stroke Case Managers (SCMs) who are trained social workers, and b)     an online informational website or portal. The 12 week intervention period begins when the     stroke patient returns home from the hospital or rehab facility. The SCMs will conduct at     least 2 home visits with the patient (one within 3-4 days and one around 30 days) along with     weekly follow-up telephone calls. Supplemental home visits will be used as necessary over the     12 week period. At the first home visit the social workers will conduct a comprehensive     in-home assessment and link patients and caregivers to local resources as necessary. Patients     also assigned to the website will have access to a patient-centered online information and     support resource called the Virtual Stroke Support Portal (VSSP). The investigators     hypothesize that this personalized case management program will reduce patient and caregiver     needs, improve quality of life, and decrease caregiver stress. The MISTT study will enroll     315 acute stroke patients discharged from 3 Michigan hospitals and will be completed by the     end of 2017.   "
48319|NCT02653157|"     This is a prospective observational study to determine the role of colonization and identify     the timing of development of drug resistance in multidrug resistant Gram-negative bacilli     (MDR-GNB) causing infection among critically ill burn patients.   "
48320|NCT02653144|"     The purpose of the study is to determine if perineural dexmedetomidine can provide increased     prolongation of analgesia when compared to perineural dexamethasone in patients receiving     regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct     to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.   "
48321|NCT02653131|"     The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like     peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of     the intestine.   "
48322|NCT02653118|"     Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to     evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in     preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types     16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from     the Nordic countries, and the highly efficient screening and surveillance system there, study     V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and Sweden.     The hypothesis being tested is that V503 vaccine will remain effective for at least 14 years     after the start of vaccination.   "
48323|NCT02653105|"     Does the olfactomédine provide an help to limit the number of false positives in the overall     imaging balance and limit the number of unnecessary biopsies?   "
48325|NCT02653079|"     Patients suffering from chronic degenerating diseases are often treated by a plethora of     NSAIDs, DMARDs, Biologicals, as well as combinations of these therapeutics. However, many     patients are refractory to this treatment and suffer from chronic pain over years, leading to     a worsening of the quality of live. The mobilization of these patients is one main goal in     the therapy of these chronic and inflammatory diseases. Low dose radiation therapy (LDRT) is     applied since more than one century for the local treatment of chronic degenerating joint     diseases. The success of the treatment was described by many retrospective as well as pattern     of care studies, respectively.      Local (only at the painful joint) low dose irradiation of the chronic patients results in     most patients in a significantly reduced pain, not only direct after the therapy, but also     lasting for more than 12 month in many cases. The patients experience enhanced mobility and     increased quality of life. The molecular and cellular processes leading to the pain reduction     are just fragmentarily analyzed. Our group revealed that macrophages are key players in     radiation-induced immune modulation. Inflammatory macrophages exposed to low doses of     radiation showed a reduced inflammatory capacity and attenuated an inflammatory     microenvironment. Besides macrophages further immune cells are most likely involved in     reduction of inflammation following LD-RT, as in vitro already shown for neutrophils.      The IMMO-LDRT01 study aims for the first time to analyze in detail the immune status of     patients suffering from inflammatory, chronic joint diseases before, during and after LD-RT     in a longitudinal manner. The multi-color flow cytometry-based assay will allow determining     over 30 immune cell subsets and additionally their activation status. Further, biodosimetry     will be performed with the whole-blood samples to get hints about dose that the immune cells     are exposed to. This will be performed with national and international co-operation partners.      The IMMO-LDRT01 study is a prospective and observational study not influencing the standard     therapeutic scheme and will provide hints how the LDRT affects besides local cells in the     irradiated area also the systemic inflammatory response.   "
48326|NCT02653066|"     The purpose of this research is to study the utility of using the HealtheRx as a tool to     recruit eligible patients into the Pulmonary Research Registry (PRR) (IRB 15543B) at the     University of Chicago. HealtheRx is an example of a potential recruitment tool that has high     reach in populations typically underrepresented in research studies, uses a high tech     infrastructure that allows matching of research opportunities to patient characteristics, but     that delivers information in a low-tech, patient-centered mode using the printed HealtheRx     prescription.   "
48327|NCT02653040|"     The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment     can improve sleep and mood in psychiatric inpatients   "
48328|NCT02653027|"     The purpose of this research study is to find out if the combined therapy     lumacaftor-ivacaftor effects how people with cystic fibrosis respond to an oral glucose     tolerance test, a test for diabetes.   "
48329|NCT02653014|"     This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to     moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of     KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma     aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to     support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III     study.   "
48330|NCT02653001|"     The aim of this project is to establish a list of volunteers willing and able to donate stool     samples for use in the model colon so as to facilitate research directed toward understanding     the basic science underlying the interactions between the gut microbiome, potential external     modifiers, and health.   "
48358|NCT02652637|"     Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery     postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before     colorectal surgery. However, several recent retrospective register studies have suggested     that mechanical bowel preparation combined to oral antibiotics before colectomy reduces     complications compared to no preparation at all. This trial compares these two strategies to     find out whether complications can indeed be reduced by mechanically preparing the bowel with     oral antibiotics.   "
48331|NCT02652988|"     In this phase II, randomized, double-blind clinical trial, the investigators intended to     evaluate the home-based effect of transcranial direct current stimulation (tDCS) in patients     with fibromyalgia. This syndrome affects between 3-5% of the population in an age group 40-60     years also occurring in childhood and old age. Reaches 3.4% of women and 0.5% of men.     Fibromyalgia is a chronic widespread pain syndrome in various parts of the body. The     neuromodulation techniques have as a principle produce inhibition or cortical arousal. The     tDCS is a non-invasive brain stimulation method used to modulate the cortical excitability,     using a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode     electrodes. The current reaches the cortex, producing hyperpolarization or depolarization of     the axonal membrane potential. Evidence has shown that this method is presented as a     technique able to alter cortical and subcortical neural networks. This technique has been     used to treat psychiatric disorders such as depression, acute mania, bipolar affective     disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal,     rehabilitation after stroke, pain syndromes such as neuropathic pain, migraine, pancreatitis     pain chronic and fibromyalgia. The tDCS is a low cost technique, with virtually no side     effects and which exerts therapeutic effect by neuromodulatory pathways by distinct pathways     activated by the drugs. In this scenario falls within the importance of developing this     device for home use by fibromyalgia patients, since it is easy to use and thereby enables     maintaining the benefit observed in studies performed and supervised frequently used in care     centers. The use of tDCS over the long term is not feasible in hospital by patients demands,     sometimes every day or more than once a week, removing the patient from their activities, and     cost shifting and overload the healthcare system. Therefore, the objective of this study is     to evaluate the effect of home-based tDCS in fibromyalgia patients in long-term treatment.   "
48332|NCT02652975|"     Several cytotoxic regimens are related to endothelial cell damage and vascular toxicity.     Endothelial dysfunction is implicated in the pathogenesis of all known cardiovascular     diseases (CVD) and closely related to the metabolic syndrome. Both CVD and diabetes     contributes importantly to total mortality and to breast cancer (BC) specific mortality.      In the epidemiological part of the project, the investigators will determine the prevalence     and incidence of cardiovascular and metabolic morbidity/mortality in early BC patients     compared to the Danish background population.      In the clinical part, the investigators will study the changes of endothelial function and     metabolic parameters in BC patients receiving chemotherapy.      With increasing number of BC survivors, long-term consequences of curative cancer treatment     should be studied. The investigators hypothesize that cytotoxic therapy worsens metabolic     parameters possibly through endothelial dysfunction. If this is true, the next step will be     to evaluate how strict metabolic control will affect prognosis.   "
48333|NCT02652962|"     The purpose of this study is to determine the safety and tolerability of Gelesis200.   "
48334|NCT02652949|"     The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and     effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending     thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.   "
48335|NCT02652936|"     This is a 2-part, single centre, single (Part 1) and multiple (Part 2) dose escalation study     in healthy male subjects.   "
48336|NCT02652923|"     This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis     scheduled for excisional surgery and sentinel lymph node (SLN) evaluation.      Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy     female volunteers to determine the optimal dose as well as the safety and tolerability of the     tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic     applications. In Part 2 lymphosonographic SLN identification will be compared to that of     isotope mapping during surgery on 90 female, breast cancer patients.   "
48391|NCT02652208|"     The purpose of the study is to compare two different types of decision support materials for     patients considering treatment for chest pain or chest discomfort from heart disease.   "
48337|NCT02652910|"     The goal of this clinical trial is to study how approaches for manufacturing chimeric antigen     receptor (CAR)-modified T (CAR-T) cells affect their in vivo persistence and therapeutic     efficacy against B lymphoma. Recently, cancer immunotherapy, treatments aiming to arm     patients with immunity specifically against cancer cells, has emerged as a promising     therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials     utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs     combine the variable region of an antibody with T-cell signaling moieties to confer T-cell     activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted     so they are not vulnerable to MHC down regulation by tumors. However, defined by the     activation and contraction program of their mother cells, the persistency and function of     CAR-T cells are also restricted by the protocol of manufacturing. Previous clinical studies     largely utilized interleukin-2 (IL-2) for the ex vivo expansion of CAR-T cells, which     preferentially generate CAR-T cells with characteristics of terminally differentiated     effector cells. Our preliminary data indicated that two common gamma chain cytokines, IL-7     and IL-15, can help to selectively expand CAR-T cells with various memory phenotypes. CAR-T     Cells prepared under this condition resulted in improved therapeutic efficacy in preclinical     animal models. This clinical investigation is to test a hypothesis whether     IL-7/IL-15-programmed anti-CD19 CAR-T cells persist longer in lymphoma patients after     infusion and whether the persistency of CAR-T cells can lead to improved anti-lymphoma     efficacy.   "
48338|NCT02652897|"     Prospective, observational study aimed to investigate the specific hemostatic alterations in     patients undergoing glial tumor resection.   "
48356|NCT02652663|"     Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the     evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for     detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm.     After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid,     gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver     lesion including CRLM. However, compared to conventional MRI with extracellular contrast     agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more     expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain     hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection.     The purpose of this study was to compare the clinical outcome and diagnostic performance of     Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal     cancer.   "
48357|NCT02652650|"     The purpose of this study is to evaluate the effect of steady-state concentrations of     JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in     healthy female participants.   "
48339|NCT02652884|"     The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in     diagnosed cases brings about an increase in the number of surgeries performed on the thyroid     gland, especially total thyroidectomy (TT), given that at present is still the gold standard     of treatment.      Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications,     with an incidence of between 10 and 46% according to different sources. HPT involves longer     hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D     (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the     health system.      While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti     emetic of corticosteroids in thyroid surgery, the literature available to date is discordant     in the use of steroid and its interaction with the HPT making clear the need for randomized     clinical trials specific to analyze these variables more accurately.      As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of     HPT component, investigators decided t conduct a prospective randomized, triple-blind, in     order to assess the potential benefits of the most common postoperative complication reported     in TT.      Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids     deposit immediately postintubation in preventing the development of transient     hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.   "
48340|NCT02652871|"     The goal of this clinical research study is to learn about the safety of LY2510924 in     combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We     will also study if LY2510924 in combination with cytarabine and idarubicin can help to     control relapsed or refractory AML.      LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream,     where they are exposed to chemotherapy (in this case, cytarabine and idarubicin).   "
48341|NCT02652858|"     Central and peripheral arterial pressure decoupling occurs in some clinical conditions like     sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as     the use of catecholamines.      The aim of this study is to evaluate the pulse wave's speed as a marker of central and     peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary     bypass during cardiac surgery.   "
48342|NCT02652845|"     This study tests the feasibility of a health and wellness trial designed with community     input. This 12-week program will be tested over a 24-week period using a delayed treatment     control group.   "
48343|NCT02652832|"     The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS     - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation - tDCS,     repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived Neurotrophic     factor (BDNF) levels in patients with depression and schizophrenia. Four blood samples will     be collected in each participants, one before the NIBS sessions, and 3 after the completion     of NIBS protocols: one immediately after the end of the NIBS sessions, a second one week     after and a last one month after. Two blood samples separated by one month will also be     collected in a a group of healthy volunteers.   "
48344|NCT02652819|"     This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of     anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.   "
48345|NCT02652806|"     This is a randomized, multicenter, open-label, active-controlled study of the treatment of     anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.   "
48346|NCT02652793|"     A 48-week, open label, non comparative prospective trial in stable chronic human     immunodeficiency virus-infected patients having achieved complete virological suppression for     more than 24 weeks (human immunodeficiency virus-1 RNA <50 c/ml) switching from an     antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted     protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at     screening, baseline, weeks 4, 12, 24, and 48.   "
48347|NCT02652780|"     The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in     improving the visual outcome in patients with LHON due to the G11778A ND4 mitochondrial     mutation when vision loss is present for more than six months and up to one year.   "
48348|NCT02652767|"     The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in     improving the visual outcome in patients with LHON due to the G11778A ND4 mitochondrial     mutation when vision loss is present for six months or less.   "
48349|NCT02652754|"     The purpose of this study is to determine the systemic exposure of Granexin® gel after     topical application to human subjects' diabetic foot ulcers.   "
48392|NCT02652195|"     The proposed study will investigate the effects of intranasal oxytocin administration on     neural activity associated with social and non-social motivation.   "
48350|NCT02652741|"     Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering     from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and     pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8     weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose     exposure in this patient population.   "
48351|NCT02652728|"     Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age,     suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric     pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat     while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to     describe the dose exposure in this patient population.   "
48352|NCT02652715|"     This pilot clinical trial studies Salvia hispanica seed in reducing the risk of returning     disease (recurrence) in patients with non-Hodgkin lymphoma. Functional foods, such as Salvia     hispanica seed, has health benefits beyond basic nutrition by reducing disease risk and     promoting optimal health. Salvia hispanica seed contains essential poly-unsaturated fatty     acids, including omega 3 alpha linoleic acid and omega 6 linoleic acid; it also contains high     levels of antioxidants and dietary soluble fiber. Salvia hispanica seed may raise omega-3     levels in the blood and/or change the bacterial populations that live in the digestive system     and reduce the risk of disease recurrence in patients with non-Hodgkin lymphoma.   "
48362|NCT02652585|"     Using theTEMA (test system for development of medications for alcoholism) it can be shown,     that naltrexone administration reduces the willingness to perform work for alcohol infusion     in a laboratory experiment.   "
48364|NCT02652559|"     Rationale:      Application of long-term non-invasive ventilation (NIV) in stable chronic obstructive     pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has     recently been shown to improve survival and quality of life when applied with sufficiently     high inspiratory pressures and adequate backup breathing frequencies (so called     high-intensity NIV). However, for a broader implementation of this therapy in a potentially     large group of patients, important issues have to be solved. First, the initiation of     high-intensity NIV, currently performed in the hospital, is often time-consuming, expensive     and inconvenient for patients. Secondly, although clinicians recognise that not all patients     benefit, it is not known which factors predict a positive response.      Objectives:        1. To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF          is non-inferior to inpatient initiation.        2. To investigate predictors of a favourable response to chronic NIV in COPD patients with          CHRF.      Study design:      The study is 1:1 two-arm parallel group randomised controlled trial comparing the usual     inpatient NIV initiation to home initiation.      Study population: Seventy-two COPD patients with a NIV indication (COPD GOLD stage III or IV;     partial arterial carbon dioxide pressure (PaCO2) > 6.0 kPa in stable condition, i.e. no COPD     exacerbation for 4 weeks and a pH > 7.35), a sufficient social network at home, without     severe cardiac comorbidities, will be included.      Intervention: Home initiation of NIV will be compared with standard in-hospital initiation.     NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre     (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be     adjusted with the use of telemedicine.      Main study parameters/endpoints:        1. To investigate non-inferiority of home initiation, the change in arterial carbon dioxide          pressure after 3 months treatment will be the primary outcome. Secondary outcomes are          safety, change in lung function, health-related quality of life (HRQoL) and costs.        2. To investigate predictors of a favourable response, patient demographics, and baseline          data on lung function as well as measures of respiratory muscle activity, arterial blood          gases, comorbidities, inflammatory blood markers and anxiety and depressions scores will          be collected of all patients.   "
48365|NCT02652546|"     Background:      When there is a threat to the body, the immune system triggers inflammation. Too much     inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick     after they start HIV drugs because their recovering immune systems cause too much     inflammation. Or their immune systems can become activated all the time. This can cause     serious health problems. Researchers want to test if the drug CC-11050 helps treat     inflammation in people taking HIV drugs.      Objectives:      To test if CC-11050 is safe and well-tolerated for people with HIV who are taking HIV drugs.     To see if it reduces inflammation.      Eligibility:      People ages 18 and older with HIV who have been on antiretroviral therapy for at least 1     year.      Design:      Participants will be screened with:      Medicine review      Physical exam and medical history      Blood and urine tests      Chest x-ray      Electrocardiogram (ECG): Soft electrodes on the skin record heart signals.      Participants will be randomly assigned to take capsules of either CC-11050 or a placebo. They     will take the capsules every day for 12 weeks. They will continue to take their HIV drugs.      Participants will have a baseline visit within 2 months of screening. This includes:      Physical exam and medical history      Blood and urine tests      ECG      Leukapheresis: Blood is removed by a needle in one arm and passed through a machine that     removes white blood cells. The rest of the blood is returned through a needle in the other     arm.      Participants will have follow-up visits 2, 4, 8, 12, and 16 weeks after the baseline visit.     These may include repeats of some of the baseline tests.   "
48366|NCT02652533|"     The investigators plan to investigate the use of US shear wave elastography (SWE), a newly     available imaging technology, in children with suspected/known BA.   "
48367|NCT02652520|"     Kidney transplantation is the treatment of choice for end stage renal diseases, increasing     life expectancy and quality of life. Improvement in organ preservation is a critical issue in     this context.      This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in     organ preservation solution in kidney transplantation.   "
48368|NCT02652507|"     The purpose of this research study is to examine the effects of two commonly used anesthetic     drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in     children, adolescents, and young adults.      The results of this study will help in making the best decisions regarding the anesthesia     medications used for sedation outside of the operating room.   "
48369|NCT02652494|"     This is a multicenter, prospective, non-interventional, observational single arm study.      Two-hundred patients will be recruited in the Netherlands over a one year period. In all     cases, the decision to treat the patient with apremilast will be made prior to the decision     to enter the subject into this study. Treatment will be according to routine clinical     practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment     will continue until 200 patients have entered the study. Each patient will be followed for 12     months.   "
48370|NCT02652481|"     The objective of this study is to collect data to confirm the safety and effectiveness of the     ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment under     the labeled Conditions of Use (Phase I).      Additionally, the study will assess medically necessary MR scans according to the labeled     Conditions of Use to provide real-world scanning data (Phase I and Phase II).      The study also aims to demonstrate the continued ability of the ImageReady MR Conditional     Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by     collecting and analyzing data from spontaneous VF episodes, for-cause VF inductions, and     from an optional VF induction Sub-study.   "
48371|NCT02652468|"     To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell     and CD19 cell depletion using HLA haploidentical donors for peripheral blood stem cell     transplant in relapsed lymphoma.      Assess incidence of acute GVHD (Graft versus Host Disease), chronic GVHD, graft failure rate,     treatment related mortality rate, progression free survival and overall survival of patients.      The stem cell product will be processed using an investigational Miltenyi cell selection     device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that     are more likely to cause GVHD.   "
48372|NCT02652455|"     The purpose of this Pilot Study is to investigate the safety, side effects, and benefits of     tumor- infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab     is a type of immunotherapy - a drug that is used to boost the ability of the immune system to     fight cancer, infection, and other diseases.      The primary endpoints of this pilot trial will be the safety and feasibility of the treatment     regimens.   "
48373|NCT02652442|"     Recent studies suggest that otolith dysfunction is a common finding in individuals with a     history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith     dysfunction may be a significant health concern for the Veteran population, and determining     optimal intervention strategies for otolith dysfunction is important for VA healthcare. The     purpose of this project is to compare the effectiveness of standard vestibular rehabilitation     compared to a novel treatment approach, centrifugation, in the treatment of individuals with     otolith dysfunction.   "
48376|NCT02652403|"     The purpose of this study is to evaluate the effectiveness of a simplified technique of     conventional dentures fabrication, comparing it to a traditional technique, by evaluating the     impact of oral health on quality of life, satisfaction of individuals and chewing efficiency     as well assessing the quality of prosthetics and TMD. Furthermore, the cost involved in the     manufacture of dentures through technique simplified will be compared to the cost involved in     the traditional technique.   "
48377|NCT02652390|"     Between 2008 and 2012 the investigators performed a single-center randomized double-blind     placebo-controlled trial to assess the efficacy of local injection of two different doses of     methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18     to 70 years, not previously treated with steroid injection. The primary outcomes were change     in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on     the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3     groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the     1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.   "
48378|NCT02652377|"     This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of     a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV)     and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.   "
48379|NCT02652364|"     This study evaluates if strong ion gap on admission or 24 hours after admission to critical     care unit can predict 28 day outcome in patients admitted with shock due to any cause   "
48380|NCT02652351|"     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord     mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.   "
48381|NCT02652338|"     The main aim of this study, which was carried out in two parallel groups, is testing the     efficacy of a specific micronutrients combination in adults with heart rhythm disturbances     and accompanying symptoms.      It is therefore the investigators hypothesis that daily oral administration of the specific     micronutrients combination will lead to a decrease of symptoms awareness and to a reduction     of heart rhythm disturbances in adults with or without structural heart disease. The     principal endpoints will be a decrease in the total score of symptoms awareness.   "
48382|NCT02652325|"     To determine if routinely available 10% povidone-iodine swabs are more effective than saline     and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.   "
48383|NCT02652312|"     The aim of this study is to calculate desflurane consumption when combined with     intraoperative dexmedetomidine infusion guided by bispectral index (BIS)   "
48384|NCT02652299|"     This study will focus on a rare cell population called fibrocytes in peripheral blood and     synovial tissue in Rheumatoid Arthritis (RA). One group of patients with early RA and one     group with long-standing RA. Both groups will be followed for 6 months.      After informed and written consent a control groups is also formed: One for synovial biopsies     for patients undergoing a routine arthroscopy, where a peripheral blood sample is also taken.      The hypothesis is that fibrocytes are present in the blood and synovial tissue in RA.     Patients with early and long-standing RA have higher concentrations of fibrocytes in     peripheral blood and synovial tissue compared to a control groups. Levels of fibrocytes in     peripheral blood and synovial tissue are correlated with RA disease activity measures and     imaging findings.   "
48385|NCT02652286|"     Video-assisted thoracic surgery (VATS) anatomical lung resection provides an effective     minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is     associated with significantly less postoperative atrial fibrillation, blood transfusion,     renal failure, and other complications when compared with lobectomy via thoracotomy.      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.     Complications include: pulmonary vascular injuries (Pulmonary artery (PA), pulmonary vein)     necessitating urgent conversion to open thoracotomy and even death. Causes of conversion     included PA injury, difficult anatomy, bulky/calcified lymph nodes, and technical problems     including stapler misfire. PA injury alone constituted 37.5% of all conversions. Proper     dissection of all tissue around PA branches is sometime difficult especially in the presence     of adhesions or large, calcified lymph nodes and may increase the risk of vascular injury.      Currently, in spite of being a safe and effective technique in experienced hands, a minority     of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the     Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung     resections were performed by VATS.      The technical difficulty and danger of VATS lobectomy is directly related to PA branch     manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic     surgeons regarding the adoption of VATS lobectomy. We believe that if we can decrease the     manipulation and dissection required by the surgeon on the PA branches, we can make these     procedures safe and therefore more prevalent for anatomical pulmonary resections.   "
48386|NCT02652273|"     The purpose of this study is to use abatacept as a clinical molecular probe to evaluate the     effects of inhibiting costimulation on immune responses in patients with rheumatoid arthritis     (RA).   "
48387|NCT02652260|"     This study aims to evaluate a switch from fixed dose combination (FDC) treatment with     ATRIPLA^TM for 12 weeks prior to screening to FDC treatment with MK-1439A in     virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants.     The primary hypothesis is that switching from ATRIPLA^TM to MK-1439A results in a lower     proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at     Week 12 than continuation of ATRIPLA^TM treatment.   "
48388|NCT02652247|"     To determine if the analysis of exhaled breath condensate correlates with the development &     resolution of pneumonia.   "
48389|NCT02652234|"     This is an open-label, single-arm study to assess the safety, tolerability and     pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.   "
48390|NCT02652221|"     A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to     quantify liver stiffness in children and young adults with chronic liver disease. ARFI     results will be compared to the current clinical standard of Magnetic Resonance Elastography     (MRE) and to liver biopsy when available.   "
48394|NCT02652169|"     Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven     therapeutic efficacy. This randomised controlled trial aims to provide evidence of the     efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for antimicrobial     compounds. The investigators therefore designed a four armed trial with three PRF arms which     are compared to each other as well as to an active comparator. The treatment arms are as     follows:      Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium     chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4:     Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be     included in this trial. Infection shall be diagnosed by an experienced senior infectious     diseases specialist. Patients with untreated peripheral vascular occlusive disease as defined     by an ABI (ancle brachial index) of < 0,7 are excluded from the trial as are patients with an     uncontrolled diabetes mellitus or patients who have not received sufficient treatment for a     diabetic foot syndrome. Any underlying illness will be treated following standard of care. In     case of chronic venous insufficiency four-layered compression bandages will be applied each     visit if tolerated by the patient. Alternatively compression stockings (Class III) are     permitted. This is mentioned as Disease specific treatment in the protocol.      Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be     compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will     be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each     visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious     diseases specialist.   "
48395|NCT02652156|"     This clinical trial will examine differences in the effectiveness between three (3) commonly     used methods and/or medications used to perform a transversus abdominis plane (TAP) block for     post-operative pain control. The transversus abdominis muscle is either side between the     lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief     treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will     undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal     form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion     of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in     this study.   "
48396|NCT02652143|"     This Clinical Study has been designed to assess and compare the impact of in vitro or in vivo     culture conditions on the euploidy of sibling blastocysts.   "
48397|NCT02652130|"     Ongoing safety assessment follow up to Protocol MSB-GVHD 001 of remestemcel-L treatment in     pediatric subjects with acute Graft versus Host Disease (aGVHD), following allogeneic     hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with     systemic corticosteroid therapy.   "
48398|NCT02652117|"     This retrospective review presents a comparison of pediatric patients less than 5 years old     undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal     epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time     to extubation, reintubation, and hypercarbia.   "
48399|NCT02652104|"     This study reviews the outcome of deep brain stimulation treated patients in Helsinki and     Uusimaa University Hospital between 2006 and 2014. The aim of the study is to investigate the     outcome and possible side effects of deep brain stimulation treatment.   "
48400|NCT02652091|"     The primary objective of this study is to assess adherence and persistence to BETASERON     therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).      The secondary objective of this study is to assess patient-reported satisfaction with the     BETACONNECT device.   "
48401|NCT02652078|"     Peripheral arterial disease is a common condition affecting approximately 64% of 56-77 year     olds. This condition restricts bloody supply to calf muscles. Pain occurs after walking a     short distance and increases in intensity until the person stops, where the pain then     gradually subsides. It can be limiting or occasionally debilitating and has been shown to     have considerable deleterious effects of patients quality of life. Shock wave therapy has     been shown to promote new blood vessel formation and improved healing amongst other findings.     This study aims to identify whether shock wave therapy that is applied to the calf muscles     causes such an effect to improve the blood supply to the calf muscles, reduce pain, improve     walking ability and quality of life.   "
48402|NCT02652065|"     Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population.     Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.      Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing     that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.      The investigators hypothesize that there is a link between cutaneous sensory neuropathies and     altered cutaneous microcirculation during psoriasis.      In order to test this hypothesis, local vasodilators will be delivered to patients by     iontophoresis and their skin blood flow in response to these molecules will be followed by     laser Doppler recordings. Two recordings will be performed for each patient, both on a     psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal     control.   "
48403|NCT02652052|"     The investigators hope to find the proof of principle concept from this pilot study so that     the investigators can design a clinical trial based on the results of the explanatory     hypothesis.   "
48404|NCT02652039|"     The purposes of this study were 1) to delineate any differences in general musical taste     (trait) and context-specific music preference (state), as well as preferred music     characteristics in cancer patients, 2) to investigate the contributions of individual     variabilities, personality, behavioral coping styles, and pain levels in predicting changes     from trait to state preferences and preferred music characteristics under various pain     conditions.      Cancer patients were recruited to fill in questionnaires pertaining to their demographic     information (age, gender, religious preference, ethnicity, music background and experience),     personality traits, music preferences, preferences for music characteristics, coping styles,     and pain experiences.   "
48405|NCT02652026|"     The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum     levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month,     single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic     generalized periodontal disease will be randomly divided into 2 groups: Treatment Group,     Control Group.   "
48406|NCT02652013|"     Multiple sclerosis (MS) progressively leads to an increasing level of disability. That's why     individuals faced with this chronic disease whose progression is unpredictable have to     mobilize all their available resources. As a result, management of interpersonal     relationships appears to be a key issue in adjustment to situations.      Although knowledge on cognitive abnormalities in MS has been growing in recent years, there     is a lack of research about social behaviour regulation skills. The few studies conducted in     this field are mainly interested in emotional processing (emotional facial recognition and     empathy) and skills mentalizing (theory of mind) that appear disturbed in MS.      While some recent studies touch on the issue of the contextual analysis of language (that is     to say, the social use of language) in MS, their assessment on a wide range of pragamtic     skills has never been studied. However, the pragmatic aspects of language are known to play a     major role in social adjustment.      This project has three main objectives : (1) to increase general knowledge of deficits in     communication and in social cognition in patients with MS, (2) to propose new leads for the     evaluation of these disorders and (3) to contribute to increasing knowledge of neural basis     of communication and social cognition.      In order to address those objectives, the assessment will be focused on many various     pragmatics skills : conversation, indirect language comprehension (indirect questions,     idiomatic expressions, sarcasm) and metapragmatic knowledge in a population of 40 RR-MS     patients. Those patients' performances will be compared to a group of healthy matched control     subjects, potential relationships between pragmatic abilities, other aspects of social     cognition (theory of mind and processing of emotional stimuli), cognitive functioning,     psycho-behavioural aspects and the characteristics of the disease will be explore.      Social cognition tasks have been selected for their dynamic and ecologic aspects in order to     match natural social interaction.      Finally, communication consideration, cognitive and cerebral skills of patients with MS will     contribute to increasing knowledge of the neural basis of social cognition.   "
48407|NCT02652000|"     Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for     localized prostate cancer   "
48408|NCT02651987|"     This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered     every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable     pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the     standard dose of lanreotide Autogel® 120 mg every 28 days.   "
48409|NCT02651974|"     This is a sub-study nested within a previously initiated clinical study (# NCT01946282)     focusing on individuals not previously randomized at baseline to the original interventions.     The purpose of the sub-study is to evaluate, via a randomized controlled trial design, 3     strategies for promoting screening completion among individuals not up to date with     colorectal cancer screening, but assigned to receive screening outreach.   "
48410|NCT02651961|"     Chronic infection after total joint arthroplasty generally requires implant exchange. Two     stage exchange is considered as the gold standard procedure. However, some authors suggest     that one stage exchange may be as effective. No consensus exists in the current literature.     The purpose of the study was to evaluate the cost of both strategies in comparison to their     success rate.   "
48411|NCT02651948|"     Primary purpose:      Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are     reduced than transrectal prostate biopsies.      Secondary purposes:        -  Patients tolerance after transperineal prostate biopsy MRI-guided is better than after          transrectal prostate biopsies.        -  Core of transperineal prostate biopsies are better than core of transrectal prostate          biopsies        -  Study of correlation between radiologic images and anatomopathologic result        -  Description of needle track during the procedure        -  Description of real time template saturation prostate biopsy        -  Comparison of transperineal prostate biopsy relevance according to EBM        -  Comparison of 1.5T MRI and 3T MRI for prostate cancer detection   "
48412|NCT02651935|"     This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV)     on the duration of ventilation compared to conventional modes in COPD patients.   "
48413|NCT02651922|"     The study was carried out as a prospective, non-interventional study with the intention of     subsequent process cost analyses (PCA) and also considers quality of life, drug misuse,     dependence, adverse events and therapy satisfaction.   "
48414|NCT02651909|"     The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in     trauma and Emergency General Surgery (EGS) patients available as point-of-care testing.      Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is     widely used in trauma and is viewed by many as superior to standard coagulation studies for     the assessment of coagulopathy following injury and may be useful in detecting rivaroxaban     effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.   "
48415|NCT02651896|"     Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer     high-fraction-size treatments would be beneficial for prostate cancer because it would     deliver a larger biological-equivalent dose to the tumor than would conventional treatment in     1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue     reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for     localized prostate cancer will improve the therapeutic ratio by either:        1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or        2. Improving tumour control, mainly freedom from biochemical failure survival.   "
48416|NCT02651883|"     This study will investigate whether cervical cancer screening completion among under-screened     women could be improved by offering HPV (human papillomavirus) testing by at-home     self-collection followed by screening invitation compared to screening invitation alone.   "
48417|NCT02651870|"     A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan     and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately     Controlled by Candesartan Monotherapy   "
48418|NCT02651857|"     Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic     Systems Utilizing EndoChoice's Full Spectrum Optical Technology   "
48431|NCT02651688|"     The purpose of this study is to compare the effects of 12 months of treatment with     enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters     in overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T≤300 ng/dL)     following a 6 month diet and 15 month exercise program.   "
48452|NCT02651415|"     The purpose of this study is to find out what effects the combination of regorafenib and     perindopril has on hand-foot skin reaction (HFSR), on high blood pressure (hypertension) and     on any other types of side-effects and compare it to the published incidence of the     side-effects with regorafenib alone.      This research is being done in an attempt to reduce the side-effects associated with     regorafenib.   "
48750|NCT02647528|"     A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser     (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris   "
48419|NCT02651844|"     -  Seventy per cent of breast cancers express estrogen (ER) and progesterone receptors (PR)          and respond to endocrine treatment.        -  Actual therapy targets ER.        -  There is enough evidence that progestins participate regulating breast cancer growth.        -  Antiprogestins block cell proliferation and increase apoptosis in breast cancer models          which express high levels of PRA.        -  Antiprogestins have been used to treat breast cancer patients that failed to other          treatments; benefits were seen in selected patients.        -  Mifepristone (MFP) is currently used for medical abortion and for the treatment of          Cushing disease.        -  MFP might exert agonistic effects when PRB isoform is activated by cAMP. This makes          mandatory the evaluation of the PR isoform ratio in breast cancer patients in which MFP          is a therapeutic possibility.      Main Goal To evaluate if therapeutic doses of MFP exert beneficial effects on breast cancers     expressing levels of PRA higher than those of PRB, evaluated as an inhibition in     proliferation markers and/or an increase in apoptotic markers.        -  Eligibility             -  Postmenopausal women (one year after menses stop).             -  Women with tumors showing ratios of PRA/PRB higher than 1.5 and PR higher than 50%.             -  Women without previous treatment.             -  All clinical stages with tumors larger than 1.5 cm.             -  Patients without autoimmune diseases and/or asthma.        -  Study design             -  Open Interventional.             -  Twenty women will take MFP (200 mg) p.o. once /day during 14 days. As for               preliminary studies, to reach this number the investigators will have to evaluate               80-100 patients.             -  Surgery is performed 14 days after treatment initiation, 24 hs after last dose.             -  PR isoform ratio will be evaluated by western blots (WB) in one core biopsy.               Additional cores will be used for diagnosis, immunohistochemistry (IHC) of PR,               Ki-67 and other markers.             -  At surgery samples will be frozen for molecular studies and fixed and processed for               pathological evaluation.             -  Wilcoxon signed rank test will be used to evaluate differences in biomarker               expression between core biopsy and surgical samples of each patient.             -  Blood will be collected before treatment initiation and prior to final surgery.             -  Mammographic and echographic studies will be carried out before and after               treatment.   "
48420|NCT02651831|"     This study aims to develop a health related quality of life (HRQOL) patient reported outcome     (PRO) for patients receiving immune checkpoint modulator (ICM) therapy. This instrument could     be used to in clinical trials to evaluate HRQOL for patients treated with novel ICMs and ICM     combinations that might ultimately influence decisions about regulatory approval, as well as     improved understanding of chronic treatment effects on patient well-being, understanding     reasons for treatment non-adherence, and developing strategies to improve adherence and     evaluating clinical outcomes.   "
48421|NCT02651818|"     The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on     the disease specific quality of life evaluated 6 months after thyroid surgery.      All investigations follow already scheduled treatments.   "
48422|NCT02651805|"     Patients with advanced chronic diseases may suffer with respiratory secretion and available     therapies to control this condition are uncomfortable or little effective in palliative care     patients. Therefore, alternative therapies should be tested, assessing clinically relevant     outcomes in palliative care, such as comfort during therapy and the number of interventions     required in a day. Mechanical Insufflation-Exsufflation is an option that presents     advantages, since it can be used in patients with minimum cooperation and is non-invasive,     which may lead to higher comfort during therapy.      The aim of the study is to verify the feasibility of a clinical trial comparing the effects     of Mechanical Insufflation-Exsufflation with usual care in hospitalized palliative care     patients that are suffering with respiratory secretion. Patients allocation will follow a     fast-track allocation design, in which included patients will be randomized in two groups:        1. Receive Mechanical Insufflation-Exsufflation therapy in the moment that is assigned to          this group;        2. will receive 24h of usual care and after that will be allowed to choose between usual          care or Mechanical Insufflation-Exsufflation Therapy.      The assessments will be: Time from the first intervention until the need of a following     intervention, discomfort due therapy, discomfort due respiratory secretion, palliative     outcome scale, number of adverse events and number of interventions during 24h period. The     primary outcome is to verify the feasibility of developing a future larger clinical trial to     assess the effects of the use of Mechanical Insufflation-Exsufflation to control respiratory     secretions in patients in palliative care.   "
48423|NCT02651792|"     The investigators aim to investigate the differences between ketamine propofol and pethidine     propofol during ERCP in respect to endoscopist satisfaction.   "
48424|NCT02651779|"     There is no consensus about the best treatment for patients with displaced complete articular     distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of     available literature on comparative data to guide treatment for this patient population,     operative treatment with plate fixation has gained popularity. The aim of this study is to     compare the functional outcome of open reduction and plate fixation with closed reduction and     plaster immobilisation in adult patients (18-75 years) with displaced complete articular     distal radius fractures.   "
48425|NCT02651766|"     The study aims to investigate the influence of 5 cupping massage treatments on chronic non     specific neck pain. 50 patients with neck pain are randomised into cupping treatment and     waiting list control group. Before and after the intervention the investigators evaluate the     neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of     life (SF36) and safety. To investigate neurophysiological effects of cupping the     investigators also measure mechanical detection threshold (MDT), vibration detection     threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold     at pain related and control areas.      The treatment group receives 5 cupping treatments over a period of 3 weeks.   "
48426|NCT02651753|"     This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to     compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.   "
48427|NCT02651740|"     The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined     fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.   "
48428|NCT02651727|"     The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in     combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to     determine a recommended Phase 2 dose (RP2D) for further development of this combination in     subjects with untreated advanced pancreatic cancer.   "
48429|NCT02651714|"     This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in     the United States in subjects with treatment-resistant pruritus diagnosed with atopic     dermatitis.   "
48430|NCT02651701|"     The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET     for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT     and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative     imaging modality in patients with rectal cancer.   "
48447|NCT02651480|"     The proposed study seeks to test the effect of a plant-based dietary intervention on     cardiovascular risk factors in police officers.   "
48432|NCT02651675|"     Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder     characterized by absent or severely reduced capacity to catabolize circulating LDL particles     by the hepatic LDL receptor. As a consequence, HoFH subjects present abnormal total plasma     cholesterol (LDL-C) levels, resulting in severe atherosclerosis often leading to early onset     of cardiovascular disease. Early initiation of aggressive treatment for these patients is     therefore essential. Unfortunately, despite existing therapies, treated LDL-C levels could     remain well above acceptable levels. Thus, the functional replacement of the defective LDLR     via AAV-based liver-directed gene therapy may be a viable approach to treat this disease and     improve response to current lipid-lowering treatments. This first-in-humans study is intended     to evaluate the safety of this gene therapy investigational product and assess preliminary     evidence of efficacy using plasma LDL-C levels as a surrogate biomarker for human LDLR     transgene expression.   "
48433|NCT02651662|"     This is an open-label, multicenter, dose escalation study of REGN2810 and REGN1979 in     patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on     how an individual patient responds to treatment. The follow-up period will be 6 months for     all patients.   "
48434|NCT02651649|"     Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor     maternal and fetal outcomes. The investigators propose a prospective observational study to     assess the utility of continuous positive airway pressure (CPAP) administration     (intervention) during pregnancy to reduce maternal and fetal morbidity. Secondarily, we will     also perform a cohort study to assess the incidence of antenatal sleep-disordered breathing     as measured by ambulatory sleep monitoring applied in the hospital setting.   "
48435|NCT02651636|"     The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic     acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS.     The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid     (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The     investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose     tolerance test, lipidic profile at baseline and after six months of treatment.   "
48436|NCT02651623|"     The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals     relative to time-matched placebo in healthy subjects   "
48437|NCT02651610|"     The primary purpose of this research study is to see whether adding bavituximab (an     investigational drug) to the standard chemotherapy drug taxane, will improve the results of     the treatment for HER2-negative metastatic breast cancer.   "
48438|NCT02651597|"     The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat     β-glucan on post-prandial glycemic response in healthy adult participants.   "
48439|NCT02651584|"     Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group     multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an     existing standard of care (SL BPN) in initiation and maintenance treatment with BPN.   "
48440|NCT02651571|"     The total knee replacement has become a routine procedure. Survival rate of over 90% after 10     years are generally reported. However, complications and reoperation may still occur for many     reasons, and some of them may be related to component design: loosening (tibial above),     polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs     can, at least in theory, improve the results of conventional models.      In this study, the investigators want to compare retrospectively data concerning survival     rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the     ones published in the literature for conventional fixed-bearing prostheses.   "
48441|NCT02651558|"     Comparison of an optical method to continuously measure blood pressure against an invasive     arterial catheter.   "
48442|NCT02651545|"     Cognitive impairment is common in MS and has devastating impact on functional activities.     There is a great demand for medications that will enhance cognitive capacity in MS patients.     The effect of teriflunomide on cognition and vocational capacity is unknown. The     investigators will address these questions in a sample of 30 relapsing MS patients treated     with teriflunomide. Cognitive impairment will be measured by calculating an information     processing speed index and a memory composite index from conventional, validated     neuropsychological tests as recommended by consensus opinion publications. Vocational     performance will be monitored using a newly developed online survey called the Multiple     Sclerosis Vocational Monitoring Survey (MSVMS). This study will elucidate the effect of     teriflunomide on these important outcomes.   "
48443|NCT02651532|"     Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. It has     prevalence in general population of 5-20% and is more common in women and young adults.      Despite being one of the most frequent reasons for consultation many patients are     undiagnosed. There are no reliable biomarkers. The diagnosis is clinical, based on the Rome     III criteria. IBS is characterized by chronic or recurrent abdominal pain associated with     changes in bowel frequency and consistency, when other etiologies are excluded. The     combination of the Rome III criteria with the absence of alarm symptoms have a sensitivity of     65%, specificity of 100%, 100% positive predictive value and negative predictive value of     76%.      Current tests commonly fail to obtain an objective diagnosis, and effective therapies are     lacking. There are no specific endoscopic findings that can discriminate IBS patients from     healthy patients. Most colonoscopies are performed to rule out other etiologies and in more     than 50% of the cases are normal.   "
48444|NCT02651519|"     Stellate-ganglion block have been done safely for more than 60 years. It has proved to     provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with     few or no side-effects. The aim of the present study is to evaluate postoperative sleep     quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed     in the operation.   "
48445|NCT02651506|"     The use of computed tomography (CT) screening has allowed for early detection of lung cancers     as small as 5mm in diameter. Early stage cancers are highly curable with a reported survival     of greater than 90% over 5 years after surgical resection. Before a patient can have surgery,     a biopsy must be performed. One common method is a transthoracic needle biopsy (TTNB). In     this procedure, a CT-image is used to locate the area for biopsy. Once identified, the     radiologist applies a local anesthetic and inserts an aspiration needle through the ribs, and     into the lung tissue. The sampled lung tissue is then sent to pathology. Although this     procedure has a diagnostic yield ranging between 70% and 85%, it is associated with serious     complications such as pneumothorax, hemoptysis, infection, hemothorax, air embolism and there     is about a 20% (range 9%-54%) incidence of pneumothorax, or air leak from the lung, requiring     chest tube drainage. Additionally, about 5-15% of cases experience hemoptysis, or coughing     blood, although significant life-threatening hemoptysis is only present in less than 1% of     patients. When these complications occur, hospitalization as inpatients is required, with an     average length of stay of 1-3 days.      A new form of technology to localize and biopsy peripheral lung lesions is believed to     significantly reduce the amount of complications that can occur during a biopsy. This     technology is known as Electromagnetic Navigation Bronchoscopy (ENB). ENB uses     electromagnetic tracking and CT-generated virtual bronchoscopy to create a three-dimensional     GPS map of the lung, guiding the surgeon directly to the tumor. The surgeon is then able to     perform bronchoscopy and biopsy the tumor from inside the bronchus. A recent systematic     review and meta-analysis of 15 trials reports a pneumothorax rate of 3.1%, with only 1.6% of     patients requiring chest tube drainage. Initial studies demonstrate a slightly lower     diagnostic yield for ENB as compared to TTNB; however, a systematic exploration of study     heterogeneity reveal that lung nodules included in TTNB studies are larger than those     included in the meta-analysis of ENB yield. The review further identified six variables     associated with increased diagnostic yields for ENB, including combined use of an ultrasonic     radial probe and catheter suctioning as a sampling technique. The superDimension® InReach™     System was granted Health Canada approval on July 23, 2009.      There have been no studies directly comparing ENB to TTNB, either retrospectively or     prospectively. Initial systematic reviews demonstrate that ENB may have a slightly lower     diagnostic yield relative to TTNB. Selection bias and low study quality may have resulted in     an underestimation of the true diagnostic yield associated with ENB. The literature also     confirms that ENB has a significantly better safety profile as compared to TTNB. As such, a     prospective comparison between the two techniques is mandated. This Phase II pilot     feasibility trial will utilize randomized methodology to gather the preliminary data that is     required for the successful completion of a Phase III randomized controlled trial to compare     lung biopsy with ENB verses TTNB. This study will also be the first time ENB lung biopsy is     documented in Canada.   "
48446|NCT02651493|"     In this study, the investigators propose a novel method to detect Down syndrome using     photography for facial dysmorphology, a tool called computer-aided diagnosis (CAD). After     validating the method, this technology will be expanded to perform similar functions to     assist in the detection of other dysmorphic syndromes.      By using photography and image analysis this automated assessment tool would have the     potential to improve the diagnosis rate and allow for remote, non-invasive diagnostic     evaluation for dysmorphologists in a timely manner.   "
48453|NCT02651402|"     Unresolved psychological problems, such as anxiety, affect a significant number of our     students and interfere with their ability to attend, actively participate, and prosper in     school. This project will expand the capacity of selected mental health agencies to provide     services in the participating schools through school therapeutic services (STS). The project     will provide enhanced training in evidence-based behavioral health interventions to     school-based mental health providers. The services will be implemented by STS Bachelor's or     Master's level therapists supervised by their mental health agency supervisors (Internal     Support), who are in turn supported by the research team (Train-the-Trainer) or external     consultants (Train the Trainer+).   "
48454|NCT02651389|"     This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.   "
48455|NCT02651376|"     Combined antiretroviral therapy (cART) efficiently suppress viral replication in majority of     AIDS patients. The morbidity and mortality of the disease has dramatically decreased over the     past 20 years. However, chronic human immunodeficiency virus-1 (HIV-1) infection lead to     profound immune defects in some advanced AIDS patients who often develop with severe     opportunistic infections (OIs), severe cachexia and other deadly complications, which     accounts for the major death group even under cART. Up-to-date, there are no effective immune     interventions to restore host holistic immunity for advanced AIDS patients.   "
48456|NCT02651363|"     The purpose of this study is to collect adverse events and identify risk factors in patients     that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®   "
48457|NCT02651350|"     This study is to observe the efficacy and safety of glucocorticosteroid treatment in the     patients with chronic recurrent drug-induced liver injury (DILI).   "
48458|NCT02651337|"     The objective of this pilot study is to perform a set of pressure and flow rate measurements     in order to quantitatively characterize safe irrigation or flushing of a ventricular shunt     catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery.     This maneuver involves injecting saline with a syringe to clear plugged shunt catheters.     Based on data obtained in Stage I of the study, a device has been fabricated which provides     the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure and     flow rate measurements generated by this specialized flusher device will be collected and     measured.   "
48459|NCT02651324|"     This study hypothesizes that the addition of a low-dose ketamine infusion to usual     post-operative pain management will improve pain control as evidenced by an improvement in     post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.   "
48460|NCT02651311|"     Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at     birth or shortly after birth, primarily resulting from unilateral shortening of     Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some     children, which is accompanied by moderate pain and discomfort. The investigators focused the     effectiveness of intermediates cervical plexus block because the dermatome of sensory of     cervical plexus block is correlated to that of torticollis. So the effect of analgesia could     decrease the use of analgesics.   "
48461|NCT02651298|"     Fractional Co2-laser for treatment of mature caesarean section scars.   "
48462|NCT02651285|"     The purpose of this study is to determine whether in Assisted Reproductive Technologies the     use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may     improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF     cycles.   "
48463|NCT02651272|"     This is a pilot study to assess the safety and efficacy of macitentan in patients with     pulmonary hypertension of sickle cell disease. This study will enroll approximately 10     subjects. Study participation for each subject will last approximately 24 weeks from     screening to end of treatment follow-up.   "
48464|NCT02651259|"     The purpose of this study is to evaluate the pharmacokinetics, tolerability, and safety of     once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and     HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB).   "
48465|NCT02651246|"     The primary goal of this optional sub-study is to record what tissues fluoresce in the     operating room, and then to identify if these lesions are cancer when the histopathology is     performed.   "
48466|NCT02651233|"     Human adipose tissue has been shown to contain a group of cells that possess extensive     proliferative capacity and the ability to differentiate into multiple cell lineages. Cells     isolated from the fatty portion are termed processed lipoaspirate cells that contain     adipose-derived regenerative cells (ADRCs). ADRCs are most conveniently extracted from tissue     during an elective cosmetic liposuction procedure but may also be obtained from resected     adipose tissue.      This study is aimed to verify if there are differences between the number and viability of     cells obtained from patients with different age, sex, Body Mass Index (BMI), smoking and     physical activity, within the different amount of processed fat.   "
48467|NCT02651220|"     A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study     to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel,     0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide)     gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris   "
48468|NCT02651207|"     Study to look at the acceptability of local anaesthetic spray versus injection, prior to     contraceptive implant insertion   "
48469|NCT02651194|"     The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with     the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection     and chronic renal impairment.   "
48493|NCT02650882|"     This study investigated the effects of an inspiratory muscle training (IMT) program on the     respiratory muscle strength and resistance and the aerobic physical performance (PP) of     handball athletes. Nineteen male athletes took part in the study, allocated at random into     the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years     old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the     maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular     respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic     PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted     to an IMT protocol 5 times a week for 12 weeks.   "
48470|NCT02651181|"     Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well     as reduce glycemic variability.      Several groups around the world investigate efforts in developing closed-loop systems.     Investigators combined two closed-loop systems with different mode of operation in order to     enhance the closed-loop system. The two systems are Hybrid closed-loop system and the     MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was     tested 'In silico' and was proved to be safe and effective. The next step is to test the     system in a clinical study in a supervised environment in a camp.      The two systems were tested separately in several clinical studies and were proven to be safe     and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system     for overnight use the GlucoSitter has a CE mark.      The purpose of this study is to collect data on the feasibility of the HLCL system in a camp     setting.   "
48471|NCT02651168|"     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.     The retina is like the film of a camera and is located in the back of the eye. This condition     can develop in diabetics where swelling results from leaking of fluid from the blood vessels     of the eye, into the center of the retina, the macula. If left untreated, this can affect     central.      The current standard treatment for diabetic macular edema includes medications injected     directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are     injected directly into the eye are known as anti-VEGF agents which help to reduce the     leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®).      However, some patients do not respond well to these anti-VEGF treatments and will be given     the option of switching to an another newer anti-VEGF medication, called aflibercept (Eylea®)     that is approved to treat DME. A recent large study has demonstrated that aflibercept was as     efficacious as other anti-VEGF therapies listed above and was even superior in patients with     worse vision (Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al.     Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema. N Engl J Med.     2015:150218140025008-150218140025008).      The purpose of this study is to determine what factors affect the treatment response to     aflibercept (amount of swelling reduction) for patients with diabetic macular edema, who were     previously unresponsive to ranibizumab injections.   "
48472|NCT02651155|"     The purpose of this study is to evaluate the efficacy and safety of oral administration of     lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic     constipation (CIC) compared with placebo.   "
48473|NCT02651142|"     Sentinel lymph node biopsy（SLNB） is an established way of predicting axillary nodal     metastasis in early breast cancer. We aim to determinethe，in a prospective randomized,     controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN)     dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on     outcomes after breast surgery.   "
48474|NCT02651129|"     The effect of noise is often underestimated but it is one of the most common occupational     health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance,     interference with speech comprehension, complaints, stress, annoyance, and safety concerns     with regard to workers being able to complete their tasks in a safe manner.      This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital     during elective and emergency cesarean deliveries.   "
48475|NCT02651116|"     This is a placebo-controlled, double-blind, randomized, parallel group pilot study in     approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on     acute cough in a pediatric population. Subjects will be otherwise healthy males and females     aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper     respiratory tract infection. Subjects must have had onset of symptoms within 3 days of     screening and qualify based on physical exam and symptom questionnaire. Eligible subjects     will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour     run-in period. Qualifying subjects will be stratified by age and then randomized to either     DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24     hours of treatment. Subjects will receive approximately 9 doses of investigational product     over the course of the 4 day study and will complete patient reported outcome questions     before the morning and afternoon doses. Subjects will return to the study site on Day 2 to     remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of     any reported adverse events will also be completed.   "
48476|NCT02651103|"     The proposed research aims to investigate how different ventilation strategies may affect     cerebral tissue oxygenation in the pediatric population. It will contribute to the literature     exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of     anesthetic and critical care settings. It may help to guide clinical practice regarding     optimal ventilation strategies, and how ventilation may be altered to correct suboptimal     cerebral tissue oxygenation.      This prospective study will include 50 patients undergoing posterior spinal fusion that     requires placement of an arterial cannulation. There will be no change in the anesthetic or     perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using     near infrared spectroscopy (NIRS).   "
48477|NCT02651090|"     Patients with renal failure or other reason for contraindication for contrast enhanced     computed tomography (CECT) or contrast enhanced magnetic resonance imaging (CEMRI) with     suspected liver pathology will be evaluated with Sonazoid enhanced Ultrasound   "
48478|NCT02651077|"     The investigators wish to highlight, in a Case-Control design, if there is an increased     concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis     with surgical indication ) versus bioaccumulation recorded in a control cohort ( women     recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis )     . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes     described by the HAS) and previous breastfeeding experience (yes / no , opposite the release     expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .   "
48479|NCT02651064|"     The USDA Healthy Incentives Pilot (HIP) evaluated the impact of a 30% financial incentive on     fruit and vegetable intake among adult participants in the USDA Supplemental Nutrition and     Assistance Program (SNAP).   "
48480|NCT02651051|"     The purpose of this study is to investigate whether the addition of whey protein to a     breakfast high in fat content will influence acute metabolic and appetite responses, as well     as responses to a subsequent lunch meal.   "
48481|NCT02651038|"     Micafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of     this class of antifungal agents are known to inhibit the synthesis of glucan polymers in     fungal cell walls. The spectrum of activity of micafungin includes Candida (all species,     including strains resistant to fluconazole), Aspergillus, and Pneumocystis.      In intensive care patients continuous venovenous haemodiafiltration (CVVHDF) is a     well-established extracorporal renal replacement therapy with a high clearance rate.      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHDF     are rare. Elimination of any given drug by renal replacement therapy is determined by several     major factors which are membrane specific, due to physico-chemical properties of the drug and     characteristics of the renal replacement technique used.      Ten intensive-care patients with acute renal failure and suspected or proven candida     infection are included into the study.      100 mg Micafungin will be infused over a period of sixty minutes via a central venous     catheter, different from the venous catheter used for CVVHDF. Blood samples will be drawn on     days 1 and 2 from the arterial and venous line of the extracorporeal circuit at 0, 2, 4, 6, 8     and 24h after starting the infusion. Plasma and ultrafiltration samples, collected from the     outlet of the ultrafiltrate compartment of the hemofilter, will be taken at corresponding     times.      The following pharmacokinetic parameters will be determined: area under the curve (AUC),     half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.   "
48482|NCT02651025|"     The purpose of this study is to determine whether a supervised resistance exercise training     during hemodialysis is effective to increase physical activity in daily life in patients with     end stage renal disease.   "
48483|NCT02651012|"     A Study to Evaluate the Efficacy and Safety Sarecycline in the Treatment of Acne Vulgaris.   "
48484|NCT02650999|"     Single center, phase I/II trial of pembrolizumab after CTL019 for CD19+ lymphomas. Patients     will have CD19+ diffuse large B-cell, follicular, or mantle cell lymphomas     relapsed/refractory after CTL019. 12 total patients will be enrolled. Safety of pembrolizumab     (primary endpoint) will be determined using a Bayesian monitoring rule for treatment-related     adverse events causing drug discontinuation. Secondary efficacy endpoints include overall     response rate and progression-free survival.   "
48485|NCT02650986|"     This phase I/IIa trial studies the side effects and best dose of a gene-modified T cells and     to see how effective it is in treating patients with solid tumors expressing cancer-testis     antigens 1 (NY-ESO-1) gene that have spread from where it started to nearby tissue or lymph     nodes (locally advanced) or have spread to other places in the body (metastatic). A T cell is     a type of immune cell that can recognize and kill abnormal cells of the body. Placing a     modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then given them     back to the patient may help the body build an immune response to kill tumor cells that     express NY-ESO-1. Drugs used in chemotherapy, such as cyclophosphamide work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading, and it may also allow genetically modified T     cells to grow.   "
48486|NCT02650973|"     This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess     PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of     CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each     period.   "
48487|NCT02650960|"     The Flemish version of the Life Balance Inventory (LBI), measuring central constructs of life     balance, will be validated in a stroke population. Upon approval by the ethical committee,     stroke patients will be recruited when they are at least six months post stroke (n = 30). The     LBI will be administered twice with one week interval, and demographic, socio-economic     variables and other measures of health related quality of life will be collected.      Next, an observational prospective longitudinal study will be set up. We will recruit stroke     patients in three rehabilitation centers within one week after admission in the     rehabilitation center. Patients will undergo a baseline evaluation and will be re-assessed at     discharge from the rehabilitation center, at six months and at 12 months post stroke. A     standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and     functional outcomes as well as personal and environmental factors will be administered. This     observational study will explore recovery patterns of bimanual activities after stroke from     baseline evaluation to six and 12 months after stroke. Also the predictive value of motor,     sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post     stroke is studied, based on data collected on admission to the rehabilitation center.     Finally, changes over time in life balance and its determinants will be examined at six and     12 months post stroke. The predictive value of motor, cognitive and functional outcomes on     life balance at one year post stroke will be examined, based on data collected on admission     to the rehabilitation center. Furthermore the influence of bimanual activities on life     balance will be explored in the chronic stage after stroke.   "
48488|NCT02650947|"     Hypothesis:        1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone          secretion and gut microbiota in healthy adults.        2. Long-term consumption of sucralose may alter food behaviour in healthy adults.   "
48489|NCT02650934|"     Objective: The purpose of this project is to study the post miyocardial infaction (MI) damage     and subsequently developed post-infarct cardiac repair process on the basis of cellular,     molecular and imaging techniques. Besides this, whole genomesequencing and analysis (GWAS)     will be performed to determine common varying genetic loci in order to anticipate     whetherthese findings and its related pathways would be the predictors of adverse remodeling     after MI or not.   "
48490|NCT02650921|"     This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness     and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the     dorsal hand to correct volume deficits.   "
48491|NCT02650908|"     The most common technique involves a suture meniscus avivement with a rasp or a motorized     cutter the suture zone before actual implementation of the suture. But the imperative nature     of this avivement is based only on theoretical considerations. The team has an old experience     in conducting meniscus sutures without avivement. It therefore seems interesting to compare     results with those of literature   "
48492|NCT02650895|"     The purpose of this study is to evaluate the safety and tolerability of single ascending     intravenous (IV) doses of CD24Fc in healthy adult subjects.   "
48494|NCT02650869|"     This prospective randomized double-blind control trial is carrying out in the neonatal unit     of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with     the diagnosis of preterm (<33 weeks gestation) VLBW (birth weight <1500g) and fulfilling the     inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included     in this study. Babies with suspicion of clinical sepsis, presence of perinatal asphyxia,     major congenital anomaly and babies who expired due to other neonatal illness were excluded.     Gestation was assessed from history of last menstrual period and after birth by new Ballard     scores. A study protocol was approved by the Institutional Ethics Committee of Sylhet M.A.G     Osmani Medical College, Sylhet.   "
48495|NCT02650856|"     The investigators will include patients who will be schedule for total knee arthroplasty with     a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a     verbal and clear detailed information will be given on the intraoperative approach. The first     group will receive topical tranexamic acid and the second group topical platelet rich plasma;     both in the surgical site. Both groups will be assessed before and after the intervention     with clinical scales (VAS) and laboratory results (hemoglobin, hematocrit levels) and     transfusion rate.   "
48496|NCT02650843|"     This project aims to clarify the role non-motor symptoms in the development of Parkinson's     disease (PD) and to improve diagnostics at very early stages of PD. The project involves     multidimensional measures of disease biomarkers together with brain dopamine transporter     (DAT) imaging with [123I]FP-CIT single photon emission computed tomography (SPECT).   "
48497|NCT02650830|"     The goal of this work is to critically test the hypothesis that there exists a different     profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with     normal controls. Through confirmation of different profile of BAs in T2DM, investigator will     suggest modulation of specific bile acids as a new possible treatment target in patients with     T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before     hyperglycemia.      In addition, investigator will evaluate the association between each BA species and serum     total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations     to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration     in serum. Investigatr also evaluates the correlation between each BA species and metabolic     profiles and oxidative stress marker to find possible roles of each BA component in glucose     metabolism.   "
48498|NCT02650817|"     The purpose of this study is to visualize and quantify ER-binding sites during treatment with     RAD1901   "
48499|NCT02650804|"     This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and     effectiveness of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as     a monotherapy or in combination with gemcitabine in advanced pancreatic cancer patients as     2nd / 3rd line therapy. The study will enroll up to 50 patients in the US and Europe.   "
48500|NCT02650791|"     It is hypothesized that a strategy using prophylactic oral Tranexamic Acid (TXA) with     therapeutic platelet transfusions is safe and effective compared to prophylactic platelet     transfusions in patients undergoing an autologous hematopoietic stem cell transplantation     (who are at risk for bleeding).   "
48501|NCT02650778|"     Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to     participate in a automated volume breast ultrasound scanner. The study evaluates     prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when     BIRADS category 3 lesions are given a 1 year follow-up recommendation.   "
48502|NCT02650765|"     A prospective validation study of the Scandinavian guidelines for initial management of     minimal, mild and moderate head injuries in adults. Enrolling a consecutive sample of 1000     adult head injury patients from the emergency department of the Tampere University Hospital     (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from     every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome     assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6     months, 1 year, and 2 years.   "
48503|NCT02650752|"     The purpose of this study is to see if capecitabine can be taken safely with different doses     of lapatinib in patients with HER-2 positive breast cancer involving brain (brain metastases)     and/or in spinal fluid (leptomeningeal disease).   "
48504|NCT02650739|"     The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring     the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared     with the surgery by the surgeon's decision. The macular hole closure and visual outcome were     compared.   "
48505|NCT02650726|"     HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a     water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO)     bioavailability and decreasing oxidative stress. This study was designed to evaluate whether     anthocyanin supplementation might improve cardiovascular function in diabetic patients.   "
48506|NCT02650713|"     This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of     RO6958688 in combination with atezolizumab.   "
48507|NCT02650700|"     Chemotherapy is one of the main treatments for advanced NSCLC. However, chemotherapy induced     thrombocytopenia (CIT) is one of the most important limitations for subsequent chemotherapy     of cancer.      At present, although platelet transfusion is the gold standard to treat severe CIT, its     clinical application is limited due to many disadvantages, such as short time for storage,     not easy to save, the risk of infection and immunological diseases. What's more, other     cytokines including IL-11 and rhTPO, are not so useful in clinical work. It is necessary to     explore a new therapeutic method to treat CIT.      Researches show that spleen resection could improve the count of PLT. In this clinical trial,     we design chemotherapy plus spleen radiotherapy to the subjects with advanced NSCLC,     simultaneously, who underwent grade II or worse CIT. The primary endpoint is the incidence of     severe CIT (≧grade III) in subsequent chemotherapy, the second endpoints are recovery time     from bone marrow suppression and progression free survival, and the exploring index is the     immulogical status.   "
48679|NCT02648451|"     -  To evaluate tolerance and acceptability of AYMES ROME in patients requiring          supplementary oral nutritional support compared with currently available alternatives.        -  To obtain data to support a submission to Advisory Committee on Borderline Substances          (ACBS) for AYMES ROME (to allow for prescription in the community at National Health          Service (NHS) expense).   "
48508|NCT02650687|"     This study will recruit surgical patients more than 65 years old. Patients who participate     will wear a sticker on their forehead during surgery which monitors their brain waves     (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain     wave patterns will be compared between patients who have problems with memory and thinking     after surgery and those who do not. The hypothesis is that there will be characteristic brain     wave patients for who will go on to have problems with memory and thinking after surgery.   "
48509|NCT02650674|"     This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five     Cereal Products in two different ethnic groups.   "
48510|NCT02650661|"     The purpose of this study is to evaluate the efficacy of the Smart Management Strategy for     Health (SMASH) program, which is designed to help cancer patients overcome their cancer     crisis proactively and grow positively.   "
48511|NCT02650648|"     This is a phase I study. The purpose of this study is to see if it is safe and feasible to     give the participant cyclophosphamide (a type of chemotherapy), natural killer (NK) cells,     and an antibody called Hu3F8 as a treatment for neuroblastoma. NK cells are a type of white     blood cell.      Funding Source- FDA OOPD   "
48512|NCT02650635|"     This phase Ib trial studies the best way of TLR8 Agonist VTX-2337 and cyclophosphamide in     treating patients with a solid tumor that has spread from the primary site (place where it     started) to other places in the body (metastatic), progressed for a long time (persistent),     come back (recurrent), or is growing, spreading, or getting worse (progressed). TLR8 Agonist     VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing.     Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving TLR8 Agonist VTX-2337 together with cyclophosphamide may     be a better treatment for solid tumors.   "
48513|NCT02650622|"     This is a prospective, non-randomized, non-blinded observational study. The overarching goal     is to discover new disease-associated genes in children, while establishing a specific focus     on disorders where molecular characterization is most likely to lead to novel therapies. This     study will merge detailed phenotypic characterization of patients presenting to the Pediatric     Genetics and Metabolism Division in the Department of Pediatrics/Children's Medical Center at     Dallas and collaborating clinics with Next-Generation sequencing techniques to identify     disease-producing mutations. The primary objective of the study is to identify novel     pathogenic mutations in children with rare Mendelian disorders. A secondary objective of the     study is to establish normative ranges of a large number of metabolites from healthy newborns     and older children.   "
48514|NCT02650609|"     Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold     standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural     hematoma involves numerous inflammatory processes which could be inhibited by steroids.   "
48515|NCT02650596|"     The investigators planned to evaluate the effects of liraglutide on left ventricular function     in chronic heart failure patients with type 2 diabetes.   "
48516|NCT02650583|"     This pilot clinical trial studies the use of the Enhancing Connections Program in improving     communication between patients with incurable cancer and their children. The Enhancing     Connections Program is an educational program that may provide patients with new competencies     to improve communication with their children and help them to cope with their parent's     incurable cancer.   "
48517|NCT02650570|"     The purpose of this study is to determine whether skeletal muscle mitochondrial function is     altered in patients with head and neck cancer compared to healthy controls.   "
48518|NCT02650557|"     The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial     Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave     dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.   "
48519|NCT02650544|"     This is a phase II, placebo-controlled, randomized, double-blinded clinical trial. Study     objective is to assess the efficacy and safety of mirtazapine in advanced NSCLC patients with     malignant tumor related depression. Study hypothesis is that advanced NSCLC diagnosed with     depression undertaking palliative chemotherapy with mirtazapine treatment for 8 weeks will     have remarkable improvement in depression compared to baseline. Eligible advanced NSCLC     Patients with PHQ-9 score ≥ 8, and undertaking palliative chemotherapy will be enrolled into     this study. patients will be stratified (gender, age, Numerical Rating Scale score for cancer     pain 0-3/4-6/7-10) randomized (1:1) into mirtazapine or placebo treatment. Patients in     mirtazapine arm will be orally administered with mirtazapine 15mg, QD, consecutive medication     for 8 weeks; along with palliative chemotherapy regimen decided by investigators. Patients in     placebo arm will be orally administered with placebo 15mg, QD, consecutive medication for 8     weeks; along with palliative chemotherapy regimen decided by investigators. During the     treatment, Patient health questionnaire (PHQ-9), Hamilton Depression Scale (HAMD-17) and     European Organization for Research on Treatment of Cancer (EORTC) quality of life     questionnaire-C30 (QLQ-C30) questionnaires will be collected at baseline, 3 weeks (d22) and 8     weeks (d57), or treatment discontinuation date due to depression deteriorated or suicidal     tendency and behavior. Follow-up will last up to 4 weeks after treatment end with depression     assessment (questionnaires every 2 weeks). Study endpoints: primary endpoint is the     anti-depression efficacy (response rate). Response defined as the PHQ-9 or HAMD-17     questionnaire score decrease ≥ 50% compared with baseline level.   "
48520|NCT02650531|"     A prospective observational multicenter study aiming to describe incidence, and identify     predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI)     after stroke   "
48521|NCT02650518|"     Hypothesis: A short course (3-5 days) of antibiotic therapy (experimental arm) is as safe and     effective as a long course of antibiotic therapy for the treatment of catheter-associated     urinary tract infections.   "
48530|NCT02650401|"     This is a 5-part, open-label, Phase 1/1b multicenter, dose escalation study in pediatric     patients with relapsed refractory solid tumors; 2) primary CNS tumors; 3) neuroblastoma; 4)     non-neuroblastoma, extracranial solid tumors with NTRK1/2/3, ROS1 or ALK gene rearrangements;     and 5) patients who are otherwise eligible but unable to swallow capsules. The study is     designed to explore the safety, maximum tolerated dose (MTD) or recommended Phase 2 dose     (RP2D), pharmacokinetics, and antitumor activity of entrectinib.   "
48522|NCT02650505|"     This is a randomized, single-center, controlled, within-subject comparison study assessing     the sensitization potential of the investigational product, LEO 43204 gel under open     conditions in healthy volunteers.      LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of     the back. Evaluation of dermal reactions at the application sites will be assessed clinically     using a visual scale that rates the degree of erythema, edema and other signs of cutaneous     irritation.      Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will     enter the Challenge Phase, which consists of one 48-hour application to a naive site on the     opposite side of the back. Observations at the naive site during Challenge and the patterns     of reactivity during the Induction Phase will provide a basis for an interpretation of     contact sensitization.      A total of 10 applications will be made over a period of approximately 6-8 weeks.   "
48523|NCT02650492|"     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.     Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a     tumor specific immunologic response. In laboratory animals the imILT method has also been     shown to induce a so called abscopal effect. This means that when one tumor is treated with     imILT other, untreated, tumors also decrease in size. The immunologic response has previously     been characterized in breast cancer patients after receiving imILT treatment , and presumed     abscopal effects induced by imILT have also been described in a malignant melanoma patient.      The purpose of this trial is to investigate the functionality and safety of the imILT     treatment method in patients diagnosed with malignant melanoma. The inflammatory process,     following on the treatment, will also be described in order to provide a more in depth     knowledge of the treatment for this indication. The purpose is also to evaluate efficiency     when it comes to local tumor destruction as well as understanding of the subsequent     immunological effects. Since immunologically based treatment of malignant melanoma is under     intense review with so called immune checkpoint inhibitors this trial will also provide     valuable information on how imILT, in the future, could be combined with these new and, for     some patients, very effective treatment regimens.      The treatment method has successfully been used for treatment of patients with breast cancer     and malignant melanoma . Treatment of breast cancer patients caused an increase of cytotoxic     T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border.     Regulatory T lymphocytes decreased in the regional lymph nodes.      This trial is explorative, prospective, open and non-randomized. Five malignant melanoma     patients stage III - IV will be treated in this trial, which is estimated to be carried out     during a time period of 12 months.   "
48524|NCT02650479|"     Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study     Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and     Female Volunteers   "
48525|NCT02650466|"     The purpose of this study is to determine if the Nanopulse System can be used to clear common     wart lesions on the skin. The Nanopulse System uses a series of low energy, high voltage     pulses, each one several billionths of a second in duration, to effectively kill the target     tissue contained within the applicator tip electrodes with minimal damage to surrounding     tissue. Efficacy and patient outcomes are expected to equal or surpass current treatment     modalities in terms of increased ease of use, faster patient healing and minimal scarring     with fewer complications resulting from treatment.      The device emits significantly less energy than existing electro-surgery or electro-cautery     equipment and is believed to be similar to laser therapy treatment of warts. Trained     clinicians can usually diagnose warts based by their appearance and location . Non-genital     warts are subcategorized into common, periungual, flat, filiform, and plantar types. Common     warts are benign, often skin-colored, or brown-grey, rough, bumpy growths on the hands and     feet (caused by Human Papilloma Virus type 2) . Common warts in individuals without any     immune deficiencies are low risk and are the focus of this study.Based upon the preclinical     profile of the Nanopulse device, particularly its safety profile and its effect on     transformed cells, it is hypothesized that application of pulses from the Nanopulse System ,     will result in complete clinical clearance of Common Wart lesions with minimal scarring.   "
48526|NCT02650453|"     Ongoing registration of deep venous obstructive disease patients treated by means of     percutaneous transluminal angioplasty (PTA) and stenting with or without endophlebectomy     (surgical desobstruction, also termed endovenectomy) of the common femoral vein and/or     arteriovenous fistula creation.   "
48527|NCT02650440|"     The objective of this study is to compare the effects of novel versus conventional locomotor     training using a robotic gait orthosis (LT-RGO) after stroke. The novel LT-RGO protocol     imposes progressive decrease of speed and guidance force as compared with the conventional     protocol which is the progressive increase of LT-RGO speed with progressive decrease of     guidance force. The hypothesis is that the novel LT-RGO protocol, by establishing a     progressive decrease in gait velocity and guidance force, may facilitate greater motor     recovery compared to the use of a conventional protocol.   "
48528|NCT02650427|"     Boosting of tumor cell killing by cytotoxic lymphocytes may be a promising means to enhance     anti-tumor immunity. Prior studies demonstrated that tumor infiltration by cytotoxic     lymphocytes correlates with control of tumor growth and is associated with an improved     prognosis in cancer patients. Trafficking of activated lymphocytes is a tightly regulated     mechanism and the specific nature of the chemokine milieu is a crucial determinant for     permitting T cell entry into the tumor microenvironment. CXCL10 is an interferon-inducible     chemokine particularly important for the recruitment of activated T, and it has been shown to     enhance anti-tumor responses through its action on cytotoxic T cells (e.g., glioblastoma,     colorectal adenocarcinoma and lung carcinoma). Additionally, roles for CXCL10 as an     anti-tumor effector include its ability to chemo-attract NK cells into sites of inflammation,     and its ability to inhibit development of new vasculature and induce the regression of newly     formed vessels. Adding a layer of complexity, the function of CXCL10 can be regulated by     dipeptidylpeptidase IV (DPPIV), leading to the formation of a dominant negative, antagonist     form of the chemokine. This was initially demonstrated in vitro, and recent work has provided     convincing in vivo evidence that antagonist forms of CXCL10 regulate lymphocyte trafficking.     The main goal of this protocol is to evaluate the tolerance of sitagliptin treatment in HCC     patients, and secondary DPPIV inhibitors as a strategy for protecting CXCL10 chemokine     agonist activity as a means to enhance tumor regression.   "
48529|NCT02650414|"     This is a single center, single arm, open-label pilot study to determine the feasibility and     safety of a single dose administered as spilt fractions of autologous T cells expressing CD22     chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory     domains (referred to as CART22 cells) in pediatric patients with relapsed or refractory     B-cell acute lymphoblastic leukemia.   "
48581|NCT02649725|"     The purpose of this study is to determine whether there is positive (beneficial) impact of     expensive cytotoxic agents on the cancer patients. It is a questionnaire based study that     will be filled by the cancer patients without obligations.   "
48531|NCT02650388|"     Aortic stenosis (AS) is the most common valve disease among the adult population, in the     majority of the cases it only requires treatment in advanced age. Transcatheter aortic valve     implantation (TAVI) has become available as an alternative treatment for very high risk or     even inoperative patients who are suffering from symptomatic aortic stenosis. Until now it     has been learnt that there are group of patients who are in a very bad condition and who are     so frail that they do not benefit from TAVI. These patients have worse survival rate and more     importantly poor quality of life in spite of a successful procedure. Cardiac surgery risk     scores like Society of Thoracic surgery score (STS) and EUROSCORE are less accurate in aging     high risk people. In elderly it is principal to make differentiation between utility and     futility. On the other hand, beside frailty status the main barrier to TAVI is the risk of     neurological impairment. Neurological injury and impairment in TAVI can occur as     cerebrovascular event (CVE) and/or neurocognitive dysfunction. The two neurocognitive     dysfunctions - post-operative delirium (POD) and post-operative cognitive dysfunction (POCD).     Most cases remain undetected although clinically could be apparent or silent. The     neurological injury can be observed and/or detected by neuroimaging techniques and cognitive     trajectories. A well established and validated frailty score based on relatively simple and     feasible tests could help in our everyday practice to evaluate the prognosis of elderly     people undergoing TAVI and to determine those patients who really benefit from the procedure.   "
48532|NCT02650375|"     This is an open-label, multicenter study designed to assess the safety, tolerability,     preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with     advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC.     Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until     disease progression or unacceptable toxicity occurred. The study will determine whether MET     gene mutation, amplification, as well as MET protein overexpression in tumor tissue correlate     with treatment efficacy and clinical outcome. The potential PD biomarker for Metatinib will     also be explored.   "
48533|NCT02650362|"     This study is an interventional prospective observatory single center trial, investigating     the supraspinal effects of long term paresthesia-free high frequency SCS in FBSS patients     with back and leg pain completed with resting state functional magnetic resonance (rs fMRI)     and voxel-based magnetic resonance morphometry (VBM).   "
48534|NCT02650349|"     This study is an interventional prospective observatory single center trial, investigating     the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high     density SCS in failed back surgery syndrome (FBSS) patients with back and leg pain completed     with resting state functional magnetic resonance (rs fMRI) and voxel-based magnetic resonance     morphometry (VBM).   "
48535|NCT02650336|"     Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated     lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive     results. The investigators explored the association between plasma aging biomakers such as     sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary     intervention (PCI) with contrast injection.   "
48536|NCT02650323|"     This registry aims to collect data related to management of patients affected by acute     coronary syndromes and hospitalized in the Campania Region of Italy   "
48537|NCT02650310|"     The embryo transfer implies transportation from the incubator where they have been at 37 ° C,     to the transfer catheter inside a laminar flow hood whose working surface is also maintained     at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature     drop, and consequently thermal stress occurs, which may compromise its future viability.      The aim of this study is to assess the possible improvement in the clinical results when the     embryos are transported in a stable device to avoid the drop in temperature throughout the     transfer process.      With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase     in pregnancy rates.   "
48538|NCT02650297|"     Patients with lymphedema may experience pain and body image issues. This study investigates     the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in     patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer     related lymphedema participated. All patients completed the body image and relationships     scale. Researchers divided the participants randomly into an intervention (n=21) or control     group (n=21). In the first phase, CDT was accompanied by use of a compression pump for four     weeks, three days per week. In the second phase, Combined DecongestiveTherapy was performed     daily without compression pump for four weeks by patients at home. At the end of each phase,     both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.   "
48539|NCT02650284|"     A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker     Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with     Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted     surgery system, Mako.   "
48540|NCT02650271|"     This study aims to compare the effect of antiviral therapy with entecavir and lamivudine for     hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included     patients will randomly divide into two groups.   "
48541|NCT02650258|"     The purpose of this study is to determine and link cadence (the number of steps taken in a     minute) to the intensity of physical activity (e.g. low-, moderate- and vigorous-intensity)     in adults (21-85 years old). The investigators anticipate that cadence will be a good     indicator of exercise intensity. Identifying how cadence relates to activity intensity will     allow for physical activity guidelines to be communicated to the public in a manner that is     more accessible to the lay person.   "
48542|NCT02650245|"     The investigators specific aim is to evaluate the changes in breath ammonia in comparison to     blood ammonia and other physiologic markers after a moderate oral protein challenge in     healthy subjects and subjects with liver cirrhosis.   "
48582|NCT02649712|"     The purpose of this study is to compare the clinical effectiveness and long-term outcomes     between patients with malignant hilar biliary obstruction who are treated by unilateral or     bilateral stenting.   "
48583|NCT02649699|"     The purpose of this pilot study is to test new magnetic resonance imaging (MRI) acquisition     and processing techniques on primary brain tumor patients. The objectives are to improve     image-guided radiation therapy (IGRT) planning (first part of the study) and treatment     monitoring (second part).   "
48543|NCT02650232|"     To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for     measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a     useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the     baroreflex. A good correlation for measuring the baroreflex sensitivity between the system     SOMNOtouch and digital photoplethysmography as a reference method is expected but should be     evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous     baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects     with heart failure. We will also evaluate the feasibility of measuring the baroreflex     sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the     baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance     test.   "
48544|NCT02650219|"     Hypergammaglobulinaemia is frequently observed in type 1 Gaucher disease (GD1), being either     polyclonal or monoclonal gammopathies. Polyclonal hypergammaglobulinemia may be related to     the presence of autoantibodies. The clinical significance of such antibodies is questioned in     Gaucher disease (GD), as some cases of immunologic thrombocytopenia and autoimmune hemolytic     anemia have also been reported.      Objectives:      To evaluate the prevalence of autoantibodies and autoimmune diseases in GD1 patients, we     conducted a multicenter national study. The investigators investigated whether there was a     link between splenectomy, genotype, therapeutic options and the presence of these     autoantibodies.They also investigated whether there was a correlation with some clinical     manifestations of GD1   "
48545|NCT02650206|"     The objective of this study is to test the hypothesis that liraglutide (commonly known as     Victoza) can promote an anti-inflammatory macrophage phenotype in human adipose tissue and     blood, thereby reducing localized and systemic inflammation which are risk factors for     cardiovascular disease and may contribute to hyperglycemia. This will be done after 4 weeks     of treatment during which weight will remain stable, and again after 12 weeks, during which     liraglutide-related weight loss occurs.   "
48546|NCT02650193|"     This is a study of how one or more injections of HSP-130 under the skin effect the white     blood cell counts and drug levels in women with breast cancer that has not spread to distant     sites in the body (non-metastatic). This will be studied in women before breast surgery or     while receiving chemotherapy. Safety will also be studied.      Additionally, the purpose of this study is to evaluate the effects and safety of single and     multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will     determine the dose to move forward for future clinical trials.   "
48547|NCT02650180|"     The Soberlink Cellular device, in its original packaging, along with the QuickStart guide     will be provided to the end user in a simulated home use environment or by Rx in clinic. The     patient labeling will be in the format intended for distribution.      Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink     Cellular device while an additional ten (10) Rx subjects will be provided instruction for use     in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10)     simulated home use subjects will be provided instruction for use for the Soberlink Cellular     device while an additional ten (10) simulated home use subjects will be provided instruction     for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects     will be provided with a post-test questionnaire on how to operate the device.      The post-test questionnaire will collect information regarding device use. The device's use     will be compared with identified risks to determine if the percentage of failures is within     the study protocol success criteria. Additionally, measurable usability criteria for     specific, critical steps will be evaluated.   "
48548|NCT02650167|"     Colostrum is the first milk secreted by the mother when the tight junctions of mammary     epithelium open, allowing the cellular transport of a multitude of components and     immunological protective derivatives of the maternal circulation to the milk, and especially     immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind     this work is that the oro pharyngeal administration of colostrum early in preterm infants     could help deliver an oral immunotherapy even before the installation of enteral nutrition,     through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract.     This practice would improve the digestive tolerance and the establishment of enteral feeding,     the decrease in mucosal inflammatory phenomena, but also to provide any protection against     subsequent infections. Finally, there could be an improvement in the secondary immune     tolerance with a decrease in the occurrence of allergic phenomena.   "
48549|NCT02650154|"     In the emergency department (ED), ketamine is a popular anesthetic agent during sedation of     children for painful and other short procedures. Sedation for procedures is more commonly     used in children than adults, to achieve motion control and cooperation. In children,     ketamine offers an ideal choice due to the fact that it is short acting, a highly effective     sedative, and preserves cardio-respiratory stability. In the United States, more than one     million children per year up to four years of age undergo short procedures requiring     anesthestic agents, including ketamine. However, there is mounting concern from animal     studies and retrospective human research regarding the safety of ketamine when administered     to infants and young children with respect to its potential toxic effects on the developing .     Conversely, ketamine has also been suggested as a neuroprotective agent. Prompt investigation     and resolution of this issue is urgently required.   "
48550|NCT02650141|"     Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It     severely threatens physical and mental health of children. It's urgent to explore effective     ways to control the disease.   "
48551|NCT02650128|"     Prospective, multi-center, single arm study designed to evaluate the safety and performance     of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary     arteries for the purpose of enhancing the placement of stents and reducing the ultimate     residual stenosis. Patients will be followed through discharge and at 30 and 180 days.   "
48584|NCT02649686|"     The purpose of this study is to find the highest dose of durvalumab that can be tolerated     without causing very severe side effects when receiving standard treatment and to see what     effects the study drug has on this type of cancer.      The researchers doing this study are also interested in looking for markers that will help     predict which patients are most likely to be helped by durvalumab when receiving standard     treatment and what effects durvalumab has on this type of cancer.   "
48552|NCT02650115|"     Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic     Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).      Because of the importance of the current global obesity, NAFLD has become very common and it     is estimated that its prevalence in the general population reaches 20-30%.      NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease)     includes a broad spectrum of liver damage, ranging from simple steatosis isolated     (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high     accumulation of extracellular components in the functional liver tissue) and finally     cirrhosis and its complications.      Choline deficiency (essential nutrient generally classified as Class B vitamins) has been     associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the     body depends in particular on food intake and degradation of choline by the intestinal     microbiota.      NAFLD and ALD are complex pathologies resulting from the interaction of environmental /     nutritional factors and a genetic background. It therefore appears now necessary to study the     influence of the relationship between genetic predisposition, environmental factors, and gut     microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD.      If the interaction of these three elements (the host genetics - environmental factors - and     intestinal microbiota metabolic choline) has an influence on the severity of the lesions of     NAFLD and ALD direct application may be of bring a food supplement choline in patients at     risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase),     postmenopausal women, microbiota profile for increased degradation of dietary choline) to     restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD     and progression to cirrhosis.   "
48553|NCT02650102|"     The aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases,     including schizophrenia (SZ). The previous work has indicated a strong genetic association     between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. However, to date, few     reports have focused on the expression level of the miR-30 family (miR-30s) and its networks     of co-regulation in SZ, even in response to antipsychotic treatment. Given this, the     investigator first constructed a hybrid miRNA-TF (transcription factor)-gene-PPI     (protein-protein interactions) network focusing on miR-30s by bioinformatics technology. The     investigator then selected several candidate miR-30s and key regulators for further     validation. These candidates were then quantified by real-time quantitative PCR (qRT-PCR) in     an independent cohort of 200 healthy controls and 200 drug-free SZ patients, among which were     followed up by 12-week antipsychotic treatment. Furthermore, the investigator evaluated the     correlation between the change in gene expression and the improvement of symptoms.   "
48554|NCT02650089|"     Both work activity and reduced nocturnal dipping of blood pressure are related to increased     cardiovascular risk. The aim of the present study was to assess the hemodynamic and autonomic     responses of university professors during teaching and sleeping times after different     resistance exercise intensities. Ten normotensive professors (33.6±3.4 years, 82.4±12.4 kg;     177.0±7.5 cm) randomly underwent control and resistance exercise before initiating their     daily activities. Resistance exercise consisted of a circuit training lasting 40min at 40%     and 80% of one repetition maximum test. Systolic blood pressure and diastolic blood pressure     as well as heart rate variability indicators in the time and frequency domains (Low     Frequency, High Frequency, Low Frequency:High Frequency ratio) were evaluated on resting and     24 hours after the sessions. The average day-time, night-time and nocturnal blood pressure     fall of systolic blood pressure and diastolic blood pressure were calculated.   "
48555|NCT02650076|"     The primary objective is to confirm the target receptor occupancy of SK-1405 and to correlate     receptor occupancy with SK-1405 dose and plasma concentration.      The secondary objective is to assess the safety and tolerability of SK-1405 in healthy,     Caucasian, male subjects.   "
48556|NCT02650063|"     The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117     ophthalmic solution (one drop once daily for 7 days) in healthy male adults.   "
48557|NCT02650050|"     Diabetes is a major cause of blindness in adults in the developed countries. The retinal     damages associated with diabetes lead to gradual loss of vision, which is accentuated when     the macula is affected. This results in macular edema.      Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are     the first line treatment of macular edema.      Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid     photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the     pigment epithelium, it would not cause the side effects of conventional photocoagulation.     Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective     treatment with a minimum injection number and without epithelial lesions.      The main objective of this study is to show that the subthreshold micropulsed laser     photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce     the number of anti-VEGF injections during the first year of treatment.      In this randomized, double blind study, eligible patients will be randomized between a     micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.   "
48558|NCT02650037|"     Anesthesia-induced atelectasis persist in the postoperative period but are not usually     diagnosed because imaging techniques are required. The aim of the study is to determine     whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we     defined as the Air Test, was able to diagnose atelectasis in the postoperative period after a     general anesthesia.   "
48559|NCT02650024|"     This partially blinded placebo-controlled trial will determine the impact of curing Hepatitis     C Virus (HCV) with an oral direct-acting antiviral (DAA), ledipasvir and sofosbuvir in a     single pill, on central nervous system (CNS) outcomes in mono- or Human Immunodeficiency     Virus (HIV) co-infected individuals.   "
48560|NCT02650011|"     Chronic liver disease including liver cirrhosis is still associated with high mortality,     although advancement of medical management and transplantation. Acute-on-chronic liver     failure (ACLF) refers to condition of previously stable chronic liver disease with occurrence     of an acute insult resulting in rapid deterioration of liver function and subsequent     decompensation. This condition is different from liver cirrhosis (chronic hepatic     decompensation) in terms of having more chance of recovery with management before acute     deterioration, although it shows high short-term mortality. Thus, earlier recognition and     intensive management are important for this condition. However, the definition or diagnostic     criteria is unclear and the natural course of this condition is not definitely investigated.     The aim of this study is to establish the natural course of ACLF in Korean patients.   "
48617|NCT02649257|"     The purpose of this study is to observe the axial IOL rotation after surgery with a capsular     tension ring (CTR) and a MC6125 AS IOL.      At the end of surgery the orientation of the IOL is documented with a short video clip via     the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6     months after surgery. Rotational stability of the IOL is assessed using retroillumination     images with a method to avoid bias from cyclorotation or head tilt.   "
48561|NCT02649998|"     Background:      Acute decompensated heart failure (ADHF) is a common and potentially fatal cause of acute     respiratory distress that requires immediate treatment in emergency department. The mortality     rates are as high as 20% after discharge. Currently, furosemide is the most commonly used     medicine in emergency department for ADHF. Although nitrate was proved to generate similar     effect when compared to furosemide, less than 30% of patients received nitrates. This     practice happens not only in Hong Kong, but also all around the world. Moreover, there is     limited evidence to support a difference in ADHF patients receiving intravenous nitrate     vasodilator therapy or alternative interventions.      The aims of the study are:        1. To monitor the changes in concentration of cardiac biomarkers, VAS dyspnoea score and          cardiac output before and after treatment of furosemide, isosorbide dinitrate or both.        2. To investigate whether the changes in concentration of cardiac biomarkers, VAS dyspnoea          score and cardiac output before and after treatment is associated with the change in          length of hospital stay.        3. To investigate whether combination treatment with intravenous furosemide and isosorbide          dinitrate in patients with HF reduces VAS dyspnoea score, in-hospital mortality, length          of hospital stay and number of readmission to a higher extend than do either medication          alone.        4. To evaluate the prognostic values of novel cardiac biomarkers on 7-day, 14-day, 30-day          and 6-month mortality and readmission.      Design:      This single-blinded randomized controlled study will be conducted in the Prince of Wales     Hospital in Hong Kong.      Setting and Subjects:      Patients with dyspnoea will be screened and recruited from adult patients attending the     emergency department at the Prince of Wales Hospital.      Interventions:      Patients with acute decompensated heart failure will be randomly treated with intravenous     furosemide, isosorbide dinitrate or both. Level of dyspnoea, multi-biomarker and haemodynamic     parameters will be measured before and after treatment.      Outcomes:      The primary outcome is the change in VAS dyspnoea score after treatment of furosemide,     isosorbide dinitrate or both. The secondary outcomes are the changes in concentration of     biomarkers and cardiac output, the number of in-hospital mortality, length of hospital stay,     7-day and 30-day and 6-month mortality and readmission.   "
48562|NCT02649985|"     The specific aims of the study are:      Primary: To determine the presence and regional distribution of microglial activation, as     assessed by Fluorine-18 (18F) labeled Peripheral Benzodiazepine Receptor 06 (PBR06) -PET,     in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive     Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls      Secondary:        1. To assess the relationship between microglial activation and clinical variables          including disease severity and comorbidities (such as pain, fatigue and/or depression),          as well as clinical MRI findings (such as lesions and atrophy)        2. A pilot substudy aims to establish the non-inferiority of [F-18]PBR06 as compared with          Carbon-11 [C-11] labeled Peripheral Benzodiazepine Receptor 28 (PBR28) PET in patients          with RRMS.      Hypothesis: The working hypothesis is that there is microglial activation in multiple     sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/     regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus     AD and correlates with disease severity and comorbidities.      In addition, the investigators hypothesize that [F-18]PBR06-PET scans will be at least as     good as [C-11]PBR28-PET scans, the current gold standard.   "
48563|NCT02649972|"     The purpose of this study is to find out what effects, good or bad, Cobimetinib has in     patients with histiocytosis. Cobimetinib is an investigational oral medication that blocks     MEK1.   "
48564|NCT02649959|"     This is a Phase III, open label extension study evaluating the continued safety and efficacy     of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.   "
48565|NCT02649933|"     To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy     course and materno foetal wellbeing.   "
48566|NCT02649920|"     At the moment in France, one delivery on four is induced for a medical indication. In this     context, the practitioners are exposed to an additional difficulty when the clinical     examination of the patient reveals a unfavorable cervix because the main drug used for the     releases cannot be used and the cervix must be previously mature.      There is a pharmacological method used and estimated in these indications of cervical     maturation: the dinoprostone (Propess®).      Other methods using a mechanical process, are under development and of evaluation as it is     the case of the probe of dilation with double balloon (Cook®).      The population of the obese women is a population in constant increase in France and     presenting deliveries to higher risks of maternal and foetal complications. At these     patients, the medicinal releases seem also more difficult and at greater risks of failures.      The investigators wish compared the efficiency of the cervical ripening balloon to the     dinoprostone within the framework of a medical indication in a release with a unfavorable     cervix in obese pregnant women.   "
48567|NCT02649907|"     Investigative trial with aim of        1. the description of the hormonal and metabolic response to meals containing different          compositions of macronutrients        2. the metabolic response to these test meals in dependance of the hepatic and muscular          insulin sensitivity and abdominal adipose tissue and        3. effects of a weight loss on the hormonal response to these test meals containing          different compositions of macronutrients      Primary endpoint:      Glucagon-like-peptide 1 (GLP-1), Glucose dependent insulinotropic peptide (GIP) and Ghrelin     response to a nutritive stimulation characterized by different nutritional composition      Secondary endpoints:        -  differences of substrate utilization depending on the nutritive composition        -  effects of different hepatic and muscular insulin sensitivity as well as impact of          visceral fat mass on the hormonal and metabolic response        -  effect of weight loss on the hormonal and metabolic response to different test meals      Study procedure:      After primary characterization 50 probands (male and female) will receive 3 different test     meals within a randomised (meal order) controlled trial.      The three different test meals differ in nutritional composition. During consumption of the     test meal a characterization of the endogenous hormonal response and appetite behaviour is     performed.      A nutritional counselling is performed according to the guidelines of the German Nutrition     Society (DGE) to ensure a stable nutritive behaviour in the three days before the test meal     administration.      After analysis of the hormonal response to these 3 different testmeals follows a weight     reduction period over 3 months. Afterwards reevaluation of the probands (again administration     of 3 different test meals over a period of 3 weeks) will be performed.      Principal aim of the study:      Gain of information leading to the understanding of the hormonal regulation of food intake.     The individual variability shall be determined with the aim of an identification of patient     groups which show various intensities of the responses to different macronutrients.   "
48568|NCT02649894|"     The purpose of this study is to determine whether a new catheter is safe and effective in     treating malignant pleural effusions compared to approve catheter.   "
48569|NCT02649881|"     This study evaluated optimal macrophage diagnosis algorithm through comparative analysis     between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable     coronary plaque accompanied with macrophage infiltration.   "
48585|NCT02649673|"     This trial will investigate the combination of two anti-cancer agents to treat patients with     relapsed/refractory small cell lung cancer (SCLC) and ovarian cancers. Oral topotecan has US     FDA approval for treating select gynecological cancers and SCLC. LCL161 is an investigational     product that has been shown in clinical trials to work together with other anti-cancer     agents. In this trial, investigators will determine the optimal dose of LCL161 and topotecan     to administer to patients with relapsed/refractory SCLC and ovarian cancers, and examine the     safety profile of the drug combination.   "
48586|NCT02649660|"     This study aims to evaluate whether platelets are biochemically and functionally altered in     Fabry disease (FD) and therefore possibly implicated in FD manifestations such as     cerebrovascular events. To test this hypothesis the investigators aim to compare platelet and     plasma lipid profiles, as well as platelet function and coagulation parameters of FD patients     and healthy controls.   "
48570|NCT02649868|"     Background:      Liver cancer begins in the cells of the liver. It can be treated with chemotherapy,     radiation, or even a liver transplant. A less invasive treatment may be able to help some     people with liver cancer. It is called percutaneous transarterial embolization (TAE). For     TAE, a material is injected into blood vessels to block the blood flow that is feeding the     tumor. Researchers want to test a new material for TAE that may shrink tumors and can be seen     on x-ray and CT images. The embolization may sometimes be combined with thermal ablation, or     cooking tumors with needles that deliver heat by electricity or microwave.      Objective:      To test an embolization material called an LC LUMI beads. To see if it can block blood     vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT     images.      Eligibility:      Adults 18 85 years old who have been diagnosed with liver cancer      Design:      Participants will have routine blood tests, physical exams, and x-rays.      Participants will be screened with blood tests, physical exam, and medical history. They will     have a computed tomography (CT) scan of the abdomen and pelvis. This will include a contrast     drink and a contrast (dye) injected in the veins.      Participants will be admitted to the clinic. They will repeat the screening tests.      Participants may have other tests. These may include x-rays, other scans, or ultrasound.      Participants will be evaluated for general anesthesia.      They will get counseling about the procedure.      Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The     beads contain iodine, which makes them visible by x-ray and by a CT scan machine.      Participants will have follow-up visits for 12 months. They will have CT scans and/or other     radiologic tests.   "
48571|NCT02649855|"     Background:      Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate     area. It can be controlled by lowering the amount of testosterone in the body. This is called     androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill     cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They think     this may work better against prostate cancer than ADT alone.      Objective:      To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than ADT     alone.      Eligibility:      Men ages 18 years and over with metastatic castrate-sensitive prostate cancer      Design:      Participants will be screened with:      Physical exam      Medical history      Blood tests      Possible CT, MRI, or bone scan: Participants lie in a machine. The machine takes pictures of     the body.      Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.      Participants will have 2 optional tumor biopsies during the study.      Participants will join 1 of 2 groups. Both groups will get:      ADT      Docetaxel by vein      Steroids by mouth or vein before each docetaxel infusion      PROSTVAC injection      Both groups first have ADT. One to 4 months after, they have:      Group A:      Docetaxel every 3 weeks for 6 cycles      PROSTVAC 3 weeks after the last infusion      Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total      Group B:      PROSTVAC      Booster 2 weeks later      Docetaxel hours later      Docetaxel and the booster every 3 weeks for 6 cycles      Participants will have a visit 4-5 weeks after the last treatment. They will then have visits     every 12 weeks.      Participants will be followed for up to 15 years. This includes physical exams every year for     5 years.   "
48572|NCT02649842|"     Post-Approval study to evaluate the rates of severe visual distortions for patients requiring     correction of approximately 3.00 D to 4.75 D of corneal astigmatism.   "
48573|NCT02649829|"     In this phase I/II trial, dendritic cells (DCs) loaded with the mesothelioma-associated tumor     antigen WT1 will be used in conjunction with conventional chemotherapy for the frontline     treatment of malignant pleural mesothelioma (MPM). The general objective is to provide the     first-in-human experimental demonstration that the combination of platinum/pemetrexed-based     chemotherapy with WT1-targeted DC vaccination is feasible and safe and enables the induction     of both systemic and in situ mesothelioma-specific immune responses in patients with MPM.   "
48574|NCT02649816|"     This retrospective cohort study assessed sealant clinical success applied to pit and fissure     by dental undergraduate students at Piracicaba Dental School - Brazil.   "
48575|NCT02649803|"     The purpose of this study is to learn the pediatric asthma control status under community     management model. To learn the differences of pediatric asthma control status when subjects     assigned to community hospitals or Shanghai Childrens Medical Centre. To learn the treatment     adherence and the frequency of asthma attack under community management model.   "
48576|NCT02649790|"     This is a first-in-human, multi-center, open-label clinical study with separate dose     escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety,     tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients     with relapsed/refractory MM.   "
48577|NCT02649777|"     The role of oxidative stress in disease pathology is increasingly recognized. At present, the     development of biomarkers of this state is in its infancy and the availability of clinically     validated assays is lacking. This study will better determine normal values for specific     biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural     occurring oxidative stress protectant. A primary and specific application of this data is for     the evaluation of oxidative stress, levels of the natural protectant taurine, and of     associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study:     Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).   "
48578|NCT02649764|"     The goal of this clinical research study is to study the safety of LY2606368 when given in     combination with fludarabine and cytarabine. The effectiveness of the study drug combination     when given to patients with relapsed or refractory AML or HRMDS will also be studied.   "
48579|NCT02649751|"     This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled     study.      The aim of this study is to assess the safety of increasing doses of roscovitine administered     orally for 4 cycles of 4 consecutive days (treatment on) separated by a 3 days treatment     free period (treatment off) in adult CF subjects with Cystic Fibrosis carrying 2 Cystic     Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected     with Pseudomonas aeruginosa.      This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.   "
48580|NCT02649738|"     This study will evaluate the outcomes of placing preserved corneal tissue within the     keratoconic cornea in order to enhance thickness, stability, and optical conformation.   "
48587|NCT02649647|"     Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for     locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of     bowel dysfunction after sphincter-preserving surgery, for which patients suffer from     incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative     chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal     cancer surgery.      Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a     major concern. When conventional surgical procedures would retain part of sigmoid colon that     has been included in the radiation target, sphincter-preserving surgery with proximally     extended resection margin could provide an intact proximal colon limb for the anastomosis.      It is not known yet whether proximally extended resection improves postoperative bowel     function or anastomotic integrity for patients with rectal cancer after neoadjuvant     chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and     without proximally extended resection margin, to observe the postoperative bowel function and     incidence of anastomotic complication. This study will examine a new surgical strategy, which     potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.   "
48588|NCT02649634|"     The purpose of this study is to determine whether adding motivational interviewing (MI) to a     behavioural weight loss program (BWLP) results in improved weight loss for adults who are     overweight or obese.   "
48589|NCT02649621|"     Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal     epithelium that are necessary for repair of corneal. About patients with deficient or absence     of this area has been proposed various treatments such as limbal stem cell transplantation.      This study is a prospective clinical trial to compare the improvement of limbal stem cell     deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).   "
48590|NCT02649608|"     To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and     metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson`s Disease.   "
48591|NCT02649595|"     The aim of this study is to determine the effect of a two week respite program (Red Cross)     for homeless people just discharged from hospitals in the capital region of Denmark.      The study is a randomized controlled trial and an economic evaluation. The intervention is a     2 week stay at a Red Cross respite care center. The intervention is intended for homeless     people or functional homeless, who has been admitted to hospital and received standard     medical care and treatment at the hospital. Under normal circumstances the homeless patients     would be discharged to live on the street and receive care from programs in the     municipalities. The respite center offers standard nursing care, rest with a place to sleep,     food and help dealing with social problems such as economy and housing. The respite care     center is led by a nurse who is represented during daytime from Monday to Friday and besides     that, volunteers are used as staff.      The control group is receiving usual care and is discharged to the street and the usual     communal programs.      The study examines whether a 2 week stay is cost effective and whether it can improve the     health related quality of live (HRQoL). The hypothesis is that a respite care stay will     result in a 25 % reduction in health care costs and increase the HRQoL.   "
48592|NCT02649582|"     In this phase I/II trial, the primary objective is to determine overall and progression-free     survival of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 (WT1)     messenger (m)RNA-loaded dendritic cell (DC) vaccination is added to adjuvant temozolomide     maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.   "
48593|NCT02649569|"     This pilot research trial studies continuous activity monitoring during fractionated     radiotherapy in patients with head and neck, lung, or gastrointestinal cancer. This study     explores the use of fitness trackers to study the activity levels of patients before, during,     and after radiation therapy and the use of weekly assessments to measure the patients'     quality of life during radiation therapy. This may allow doctors to see if there is any     relationship between activity levels, quality of life, treatment interruptions,     hospitalizations, and clinical outcomes.   "
48594|NCT02649556|"     The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco     Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to     conventional cigarettes (CC) on the components of the smokers' health profile for a     prolonged period of 26 weeks, providing additional information to the results of the original     study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US     study will extend the exposure period to 52 weeks.   "
48595|NCT02649543|"     The objective of the study is to compare infection rates between primary, delayed primary and     vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.   "
48596|NCT02649530|"     Given that up-regulation of the Wnt pathway has been identified as having a significant role     in carcinogenesis in advanced head and neck squamous cell carcinoma, the investigator     believes that inhibition of Porcupine via WNT974 will result in tumor control hence     improvement in disease free and overall survival in these patients with a tolerable toxicity     profile. As suggested by pre-clinical models, patients with a tumor harboring a Notch     receptor (any of the four) loss of function mutation may have a greater response rate to     treatment with WNT974. The investigator aims to address this question by administration of     single agent WNT974 and following response radiologically along with close clinical follow up     to monitor toxicities.   "
48597|NCT02649517|"     The purpose of the study is to investigate the clinical and morphological characteristics of     chronic subclinical inflammation in the myocardium in patients with decompensated heart     failure with ischemic systolic dysfunction.   "
48598|NCT02649504|"     The investigators will attempt to further increase the cure rate of ITP with medical therapy     by providing maintenance therapy with Mycophenolate mofetil (MMF) to persistent/chronic ITP     patients after treating them with induction therapy combining rituximab and dexamethasone.     The investigators will randomly assign patients to MMF versus placebo in order to demonstrate     safety (e.g., for infectious risk) and efficacy (platelet counts stably >50x109/L more than 1     year off therapy).   "
48614|NCT02649296|"     The purpose is to find out the effect of Skanlab at knee arthrosis.   "
48615|NCT02649283|"     This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess     the safety and performance of the OrbiSymm system in subjects referred to contra lateral     breast symmetrization involving a breast reduction following breast reconstruction     post-mastectomy.   "
48599|NCT02649491|"     Scientists have developed an instrument which works like an electronic nose. It is able to     sniff smells and separate different smells by their electronic signature. Studies using     an electronic nose strongly suggest that smelling samples taken from humans (e.g. urine/     stool/ sweat/ tears) can identify different electronic smell signature from people with     different diseases and in the future might be a new and easier way to diagnose serious     conditions at an earlier stage.      In a very small study, it has been successfully shown that using an electronic nose to sniff     a stool sample does seem to identify people before they have had any radiotherapy - who will     go on to get serious bowel side effects of radiotherapy. If this finding is correct, this is     very important as it would allow the cancer doctors the option to change the way they give     radiotherapy if they knew that a person was at very high risk of serious side effects from     the treatment and to start treatment for the side effects at a much earlier stage.      In this study the investigators want to confirm in a larger study whether the previous     findings are correct, and to see whether similar results can be obtained by sniffing urine     rather than stool (that would be much easier for everyone) and identify exactly which part of     the complicated smell signature is different in the people who will get side effects. This     may lead for the investigators to able to identify why people are making this specific smell     and then do something about changing the smell before treatment starts. The likeliest cause     for the production of a smell which predisposes to side effects is a specific group of germs     living in the bowel. If these germs can be identified, then there are many possible ways of     changing these germ populations in advance of radiotherapy.      Enormous improvements have been made in treating cancer in recent years leading to hugely     improved survival, however, treatment not infrequently can lead to side effects. Of all the     possible long term physical side effects of cancer treatment, gastrointestinal (GI) symptoms     are the most common and can have a great impact on daily activity. It is becoming     increasingly clear that development of side effects in the bowel is not just related to the     dose and way the radiotherapy is delivered.   "
48600|NCT02649478|"     A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of     Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder     Compared with Advair Diskus® 100/50 in Subjects with Asthma   "
48601|NCT02649465|"     1. Objectives        1. Which organ and how does SGLT2 inhibitor alter insulin sensitivity?        2. How does SGLT2 inhibitor increase glucagon levels and hepatic glucose production?   "
48602|NCT02649452|"     Whole body vibration (WBV) can help to improve muscle flexibility by stimulating the     neuromuscular functions. But there is a dearth in the literature to prove its effectiveness     in improving the flexibility of the upper limb muscles. Therefore the purpose of the study is     to determine the effects of vibration on improving upper limb flexibility. This experimental     research will be conducted by recruiting participants at the age of 19 to 27 with no     histories of injuries on the upper limb. They will be randomly assigned into two groups;     experimental (with vibration) and control (no vibration) group. The WBV machine will be used     to provide vibration to the upper extremities by placing both palms on the vibration     platform. The outcome measure of active chest flexibility and shoulder reach flexibility will     be performed pre and post vibration.   "
48603|NCT02649439|"     Background:      Some people who have been treated for prostate cancer still have high prostate-specific     antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration     sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers     think the immune system can be taught to fight and kill cancer cells. They think an     immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type     of prostate cancer.      Objective:      To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting     surveillance alone.      Eligibility:      Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Bone scan      CT scan, or MRI and PET scan: They lie in a machine that takes pictures of the body.      Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.      Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will     have surveillance for 6 months followed by prostvac for 6 months.      During the prostvac period, participants will get prostvac as a shot under the skin on weeks     1, 3, and 5, and then monthly for a total of 5 months.      Participants will have follow-up visits at least every month until they recover from prostvac     side effects or their cancer worsens. Visits may include repeats of screening tests.      Participants will be followed for up to 15 years. They will have a physical exam every year     for the first 5 years. They will have phone calls once a year.   "
48604|NCT02649426|"     RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO)     designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation     System in two distinct populations of hypertensive subjects.   "
48605|NCT02649413|"     The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration     of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for     steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the     investigators will adjusted the first steroids does to the response day. Our primary end     point is : a lower adjusted dose is as good as the fix dose in the first year after     diagnosis.   "
48606|NCT02649400|"     This study assesses the impact of diastolic heart failure on exercise capacity in women who     have a previous coronary condition. All the participants will go through the same evaluation.   "
48607|NCT02649387|"     This phase II trial studies the side effects and how well ibrutinib works in treating     patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce     a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth.   "
48608|NCT02649374|"     The purpose of this study is to document the gut microbiome in the 1st, 2nd and 3rd trimester     among pregnant women with gestational diabetes and non diabetic controls.   "
48609|NCT02649361|"     To compare the effects and safety of Anlotinib with placebo in patients with esophageal     squamous cell carcinoma(ESCC).   "
48610|NCT02649348|"     A prospective randomised controlled trial to investigate effects of preoperative exercise and     eliminating abdominal breathing on perioperative outcome in gastric cancer patients with     metabolic syndrome who will undergoing laparoscopic gastrectomy.   "
48611|NCT02649335|"     Cirrhosis is the leading cause of death in India and worldwide and leading causes in     developed world include alcoholic liver disease, hepatitis C, and more recently,     non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH). As cirrhosis     advances, portal hypertension develops, resulting in complications such as ascites, hepatic     encephalopathy, and variceal hemorrhage.      Ascites is the most common major complication of cirrhosis, occurring in 50-60% of patients     within ten years of diagnosis . Development of ascites is an ominous landmark in disease     progression as 15% of patients with ascites will die within 1 year, and 44% within 5 years.     Less than 10% patients develop refractory ascites and is associated with a poor prognosis     with a high mortality, approximately 50% within 6 months and 75% at 1 year with the median     survival approximately 6 months . Refractory ascites occurs as a result of splanchnic     vasodilatation and maximal activation of the sympathetic nervous system (SNS) and the renin -     aldosterone system (RAAS) . The therapeutic options available for these patients are serial     therapeutic paracentesis, liver transplantation and trans jugular intrahepatic portosystemic     shunts .The model for end stage liver disease( MELD) score predicts survival in patients with     cirrhosis . However, other factors in patients with cirrhosis and ascites are also associated     with poor prognosis, including low mean arterial pressure; low serum sodium, low urine     sodium, and high Child-Pugh score .      Variceal bleed is the most dreaded complication of cirrhosis and screening endoscopic is     recommend in these patients. About 60% of patients with decompensated cirrhosis have varices     at the time of diagnosis. Majority of these patients will require non selective beta blockers     (NSBB) as standard of care as primary or secondary prophylaxis in prevention of variceal     hemorrhage. NSBB reduce portal pressure by decreasing cardiac output and by producing     splanchnic vasoconstriction.. Endoscopic variceal band ligation (EVL) is another modality of     treatment of esophageal varices and meta-analysis showed EVL to be associated with     significantly lower incidence of first variceal hemorrhage without differences in mortality     compared to NSBB. NSBB also has shown to improve survival in these patients with     nonhemodynamic effects. Some of the patients may progress to end stage liver disease     characterized by the development of refractory ascites and other complications.      Most of the studies of NSBB comparing to EVL for primary/secondary prevention of variceal     hemorrhage included patients of predominantly child A/B cirrhosis with variable number with     ascites without any mention of ascites grading and some of trials excluded patient's with     refractory ascites. These patients with ascites received diuretics and salt restricted diet     as standard of care. However none of these studies mentioned about control of ascites and     survival benefit in patients with advanced stage (child B and C) cirrhosis with ascites .In     recent years the role of NSBB for prevention of variceal hemorrhage in refractory ascites     patients has been questioned because of the deleterious effect on survival.However the use of     NSBB in end stage liver disease has shown mixed results and controversial.      Therefore this study is being planned to know the effects of NSBB in advanced stage liver     disease patients with ascites and varices in preventing variceal hemorrhage ,effect on     ascites and survival.   "
48612|NCT02649322|"     Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for     pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional     anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic     knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected     lidocaine prior to regional and general anesthesia.   "
48613|NCT02649309|"     This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to     evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in     patient undergoing coronary angioplasty.   "
48618|NCT02649244|"     The purpose of this study is to examine the effectiveness of the Family Caregiver Training     Program for caregivers of people with dementia, using a pretest posttest randomized control     trial with 3-month follow-up. The Family Caregiver Training Program will consist of 3-hours     and hence, three modules over the course of one day. Module one will present information on     communication, eating, and nutrition, module two will focus on transfers and toileting, and     module three will focus on bathing, grooming, and dressing. The control group will receive     standard care as relevant to dementia family caregivers including general information on the     progression of dementia, and helpful resources as suggested by the Alzheimer's Association. A     convenience sample of 36 family caregivers will be recruited by flyers posted throughout     local area community boards and Alzheimer's Association media outlets. A repeated measures     ANOVA will be used to assess the group differences in knowledge and confidence at three time     points (pre-intervention, post-intervention, and 3-months post-intervention). Changes in     caregiver burden, depression, quality of life, and occupational performance and satisfaction     will be assessed 3-months post-intervention.   "
48619|NCT02649231|"     96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine     (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3     sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3     and 6 months on a range of psychological and biological variables. Primary endpoints will be     % days abstinent at 3 and 6 months and relapse rates at 6 months. Secondary endpoints include     depressive symptoms, craving, quality of life.   "
48620|NCT02649218|"     A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4     weeks for 52 weeks in Chronic Spontaneous Urticaria patients who completed study CQGE031C2201   "
48621|NCT02649205|"     The purpose of this study is to characterise the patient and disease profile under the     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),     focusing on the progression of chronic renal insufficiency, calcium and phosphorus     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as     the persistent dietary education to ensure compliance in a large group of pre-dialysis     patients.   "
48622|NCT02649192|"     Children are particularly vulnerable to respiratory virus infections, especially influenza.     Vitamin A & D deficiencies are associated with vulnerability to infectious diseases of the     respiratory tract. The central hypothesis of this protocol is that vitamin supplements will     enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will     be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza     virus vaccine with placebo. Children will be tested for vitamin levels and immune responses     before and after influenza virus vaccinations to determine if vitamin supplementation     improves the influenza virus vaccine-induced immune response.      PRIMARY OBJECTIVE:        -  To assess the vaccine-induced and total antibody (including IgG and IgA) response after          influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56 days          in sera      SECONDARY OBJECTIVE:        -  To assess the neutralizing response toward influenza virus vaccine in the sera.   "
48623|NCT02649179|"     The purpose of this study is to evaluate the effect of pain relief after infusion of     ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo     (0.9% normal saline).   "
48624|NCT02649166|"     Essential tremor is an incurable, degenerative brain disorder that results in increasingly     debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25%     of essential tremor patients were forced to change jobs or take early retirement because of     tremor. Essential tremor is directly linked to progressive functional impairment, social     embarrassment, and even depression. The tremor associated with essential tremor is typically     slow, involves the hands (and sometimes the head and voice), worsens with intentional     movements, and is insidiously progressive over many years. Deep brain stimulation has emerged     as a highly effective treatment for intractable, debilitating essential tremor. However,     since the intention tremor of essential tremor is typically intermittent, and commonly absent     at rest, the currently available continuous deep brain stimulation may be delivering     unnecessary current to the brain that increases undesirable side effects such as slurred     speech and walking difficulty, and hastens the depletion of device batteries, necessitating     more frequent surgical procedures to replace spent pulse generators. The overall objective of     this early feasibility study is to provide preliminary data on the safety and efficacy of     closed-loop deep brain stimulation for intention tremor using novel deep brain stimulation     devices capable of continuously sensing brain activity and delivering therapeutic stimulation     only when necessary to suppress tremor.   "
48625|NCT02649153|"     Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience     temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and     chewing gum can reduce the bowel paralysis after hepatic resection in patients with     hepatocellular carcinoma. One third of the study population will receive smoked plum, one     third with chewing gum, and the last will act as empty control.   "
48626|NCT02649140|"     Purpose:      The aim of this present study is to investigate the effect of vinegar consumption on 24-hour     urinary risk factors associated with calcium oxalate urinary stone formation and blood     biochemical parameters.      Methods:      The investigators will recruit 50 healthy young student volunteers in this study. By simple     random sampling technique, volunteers will be allocated to two groups (group 1, control     group; group 2, vinegar group).Each participant in vinegar group drink 15ml vinegar (     Ninghuafu, Sanxi, China) at noon and evening respectively for a period of four weeks.The end     point of this study is comparison the outcomes of 24-hour urine and blood biochemical     parameters between different group and point-in-time.   "
48627|NCT02649127|"     This is an 8-week experimental, repeated-measures clinical trial randomizing 120 Service     Members with symptoms of PTSD into one of four groups: 1) imaginal exercises of exposure     therapy only, 2) aerobic exercise only, 3) imaginal exercises augmented with aerobic     exercise, or 4) self-care.   "
48656|NCT02648750|"     This feasibility study evaluates whether it is possible to run a larger scale study to     investigate the use of a self-management programme with adults who have recently had a     stroke. Half of the participants will receive support with self-management from stroke     therapists, while the other half will receive it from rehabilitation assistants.   "
48628|NCT02649114|"     The combination of EDs (ED) and post-traumatic sequelae of childhood trauma leads to     significant impairment, suffering and represents a public health concern because it is     frequently associated with role impairment, and is frequently under-treated. Considering the     severity of these conditions, there is a need to develop more effective treatments that are     tailored to the specific needs of these patients as no conclusion has been made about the     treatment of choice. To improve treatment it is critically important to study treatment     effects and the mechanism of these effects.   "
48629|NCT02649101|"     Sixty advanced breast cancer patients are planed to enrolled in this clinical trial. Forty     patients are enrolled into thalidomide plus chemotherapy group. Twenty patients are enrolled     into chemotherapy alone group. There is no restriction on chemotherapy regimen and lines.   "
48630|NCT02649088|"     Prospective observational study designed to implement a daily monitoring of microcirculation     and tissue oxygenation in all critically ill patients admitted to the ICU in the period of     nine months, in order to assess the prevalence of microvascular perfusion abnormalities and     their relation to: outcomes, underlying disease, hospital stay, clinical-laboratory and     hemodynamic parameters commonly measured, indices of clinical severity and predictors of     mortality , therapeutic interventions that are part of routine clinical practice (fluids,     sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood     transfusion). The study also includes the evaluation of sublingual microcirculation and     tissue oxygenation in 30 healthy volunteers to compare normal and pathological conditions.     Within the first 12 hours after admission to ICU and every 24 hours for the duration of     hospitalization, the following evaluations will be made: -study of sublingual     microcirculation using sidestream dark field (SDF) imaging, muscle tissue oxygenation using     near infrared spectroscopy (NIRS). The data will be analyzed to test correlation between the     outcome of patients admitted in ICU and microcirculatory parameters.   "
48631|NCT02649075|"     The objective of this study is to evaluate the nutritional therapy with SBI (a medical food)     as compared to placebo in the clinical dietary management of mild to moderate Crohn's     disease.   "
48632|NCT02649062|"     The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid     homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.   "
48633|NCT02649049|"     Patients with NAFLD and matched controls will be asked about their demographic status, and     their previous year dietary intakes using a validated FFQ.   "
48634|NCT02649036|"     Background:      Inequality in access to healthcare is a challenge internationally. Despite that medical     emergency calls can be considered as access point to pre-hospital emergency care and hospital     admission in emergency situations, no data on inequality in access to healthcare through     emergency calls is reported in the international literature.      Study aims:      The aim of this study is two-fold:        1. to evaluate the association between socio-economic characteristics of citizens and          first-time emergency call in the Capital Region of Denmark        2. to evaluate the association between socio-economic characteristics of citizens with an          emergency call and the priority level of the response provided by the emergency medical          dispatch center in the Capital Region of Denmark.      Method: Observational register based study of adult citizens in the Capital Region of     Denmark. Educational level, household income and employment are used as socioeconomic     indicators. The unique civil registration number will be used to link data from the Emergency     Medical Dispatch Center with data from the Civil Registration System, Danish registers on     personal labor market affiliation, the Danish Populations Education Register, the Danish     Income Statistics Registry and the national patient registry. Logistic regression models will     be used for the association between socio economic indicators and first time emergency calls     and the association between socioeconomic indicators and the priority level of the response     provided.   "
48635|NCT02649023|"     To investigate the incidence of pre- and early postoperative deep venous thrombosis in     patients undergoing hepatobiliopancreatic surgery, as well as potential corresponding risk     factors with special attention to circulating tumor cells.   "
48636|NCT02649010|"     The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in     subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor     performance in arm in subjects age 14 - 75 years.   "
48637|NCT02648997|"     This research study is studying a targeted immunotherapy as a possible treatment for     Recurrent Meningioma. The name of the study intervention involved in this study is Nivolumab.   "
48638|NCT02648984|"     Pulmonary arterial hypertension (PAH) in patients with congenital heart disease usually     develops secondary to chronic volume overload of the pulmonary circulation following left to     right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to     increased pulmonary vascular resistance (PVR), leading to right ventricular dysfunction,     considerable morbidity and even mortality.      Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease     already evolved to an advanced stage and treatment is often initiated too late. Our research     group standardized the technique for the detection of early pulmonary vascular disease by     bicycle stress echocardiography. The investigators now aim to assess this exercise technique     in a group of patients with ventricular septal defect.   "
48639|NCT02648971|"     This randomized, controlled clinical trial will compare the outcomes of single portal versus     two portal techniques in patients who have meniscus or articular cartilage pathology. The     study hypothesis is that patients who undergo single portal arthroscopy will have less pain     post-operatively, use less pain medication, and have a higher International Knee     Documentation Committee (IKDC) score at six months and one year compared to patients who     undergo traditional two portal knee arthroscopy.   "
48640|NCT02648958|"     Ischemia reperfusion injury causes the release of free oxygen radicals. The selective     alpha2-receptor agonist, dexmedetomidine, has an inhibitory effect on inflammatory responses     during ischemic injury. The aim of this study is to evaluate the effect of dexmedetomidine on     inflammatory responses during ischemia-reperfusion injury in skeletal muscle.   "
48669|NCT02648581|"     The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in     subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients     with active posterior uveitis or panuveitis (STELABEC-2)   "
48641|NCT02648945|"     Anxiety levels among the younger generation especially students have been increasing     drastically in recent years. This severely affects a student's academics as previous studies     have shown a strong correlation between high anxiety levels and poor working memory. Working     memory, also known as short term memory is an important component in studying as it aids in     holding important information needed to understand following information for a short period     of time. This concerning phenomenon has drawn the attention of researchers to find solutions     to this issue where recent studies have found physical exercise to contribute in the     improvement of cognition which also includes working memory. Hence, the aim of this study is     to compare the effects of low and high intensity exercises on working memory among students     with high anxiety levels. Thirty female undergraduate students from UTAR with relatively high     levels of anxiety will be conveniently sampled using Beck Anxiety Inventory. Participants     will then be randomly allocated into 2 groups to undergo low and high intensity exercise on a     treadmill according to Balke's Protocol. 2 memory assessments involving Verbal Memory Task     will be conducted for each participant before and after the intervention.   "
48642|NCT02648932|"     The study seeks to compare time from formal search to hematopoietic cell transplantation     (HCT) for patients 18 years and older, randomized between haplo-cord search and matched     unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk     myelodysplastic syndrome (MDS)   "
48643|NCT02648919|"     The purpose of this study is to evaluate the effects of Noni extract in men diagnosed with     very low risk or low risk prostate cancer   "
48644|NCT02648906|"     The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and     Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer     patients   "
48645|NCT02648893|"     In this study, a multiple food crops basket (containing four either biofortified or     commercially-available food crops) will be fed to young children in Mumbai, Maharashtra,     India over a period of nine months to measure growth, cognitive changes, and immune function     in comparison to children receiving non-biofortified crops.      Potentially, lactating women (their mothers) will also be included in the study.   "
48646|NCT02648880|"     The purpose of this study is to investigate the effects of a preoperative exercise program in     patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have     been shown to be effective in other cancer populations, but have not been investigated in     patients with pancreatic cancer. The outcomes in this study will be changes in physical     fitness, function, and postoperative outcomes. This investigation is a non-randomized control     trial, with participants assigned to receive the preoperative exercise intervention in     addition to standard care, or standard care alone if unable to commit to an exercise program     for practical reasons. Possible mediators for the effects of exercise on postoperative     outcomes will also be assessed, including psychological outcomes and markers of systemic     inflammation. These measures will be assessed in all participants prior to program     initiation, prior to surgery, and after surgery. Changes in these measures in response to     exercise will be assessed, as well as the ability of the preoperative measures to predict     postoperative outcomes.   "
48647|NCT02648867|"     This study will assess the ability for continuous electronic feedback to reduce the length of     second stage labor and improve maternal and fetal outcomes.   "
48648|NCT02648854|"     This study is A randomized, open-label, single dose, 2-way crossover study to investigate the     effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.   "
48649|NCT02648841|"     The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients     with local advanced gastric cancer.   "
48650|NCT02648828|"     The purpose of the study is to compare the ability of physicians and a statistical index (the     Rothman score) to predict clinical deterioration over the next 24 hours. Clinical     deterioration is defined as concern in change in vital signs or patient status requiring a     call to the rapid response team, cardiopulmonary arrest, or transfer to the ICU.   "
48651|NCT02648815|"     This study aims to investigate the natural clinical course, diagnostic possibilities and     treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The     management of severe acute pancreatitis varies with the severity and depends on the type of     complication that requires treatment. Although no universally accepted treatment algorithm     exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage,     followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to     produce superior outcomes to traditional open necrosectomy and may be considered as the     reference standard intervention for this disorder.   "
48652|NCT02648802|"     This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS)     on pathological cavity margin (CM) status in breast cancer patients. Patients receiving     standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment     versus intra-operative CS followed by CM assessment. The primary objective of this study is     to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate,     post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time     and medical costs.   "
48653|NCT02648789|"     The purpose of this study is to investigate the correlation between DNA methylation and the     treatment and recurrence of oral cancer.   "
48654|NCT02648776|"     The aims of this study are to (1) examine the medication use patterns of commonly prescribed     hypnotics and the factors that were associated with the long-term and short-term use patterns     among the elderly population in Taiwan; (2)investigate the associations of using hypnotics     with the elderly patients' disease statuses, efficacy and safety, as well as its     pharmacokinetic and pharmacogenetic characteristics;(3) determine the clinical, economic and     humanistic outcomes of using hypnotics and the corresponding contributing factors for the     elderly in Taiwan.   "
48655|NCT02648763|"     The purpose of this study is to evaluate the accuracy of participants imaging versus staging     procedures. The investigators will consent subjects that are scheduled to undergo staging     procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy,     endobronchial ultrasound and laparoscopy) as part of their standard of care.   "
48657|NCT02648737|"     Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a     negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life. With     this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive     Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this module     in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral connectivity.     Effective CBT treatment of anxiety will provide patients with behavioural and anxiety     management techniques that can give lasting benefits, not only on anxiety symptoms, but     potentially also on motor symptoms.   "
48659|NCT02648711|"     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended     Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule 1) and in     combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week on / 1 week     off schedule in combination with mFOLFOX6 (Schedule 3) to affirm the dose for future clinical     studies.   "
48660|NCT02648698|"     82 cases with a diagnosis of chronic endometritis, confirmed by the presence of plasma cells     in endometrial biopsy sample identified by immunohistochemical staining using CD138 antibody,     will be recruited. The subjects will be randomly divided into two groups, the experimental     group will be given antibiotic (Augmentin) treatment, the control group will be given     placebo. A repeat endometrial biopsy sample will be obtained one month after completion of     the antibiotic therapy to assess the response to treatment. The cure rate will be compared     between the two groups   "
48661|NCT02648685|"     There was no any China mainland data showing the contribution of BBG and PBG to HbA1c in T2DM     patients treated with OADs using the CGM method. Therefore this study is aimed to investigate     the contribution of BBG and PBG to HbA1c in Chinese T2DM patients treated with OADs using     CGMS. It's expected to generate evidence to support the concept of individualized therapy     when patients are uncontrolled by OADs.   "
48662|NCT02648672|"     This is a randomized double-blind (investigator and subject blinded), placebo controlled     ascending single dose study to evaluate the safety, tolerability, and pharmacokinetic profile     of BPN14770 in healthy male and female subjects. Each subject will be randomized to receive     either a single dose of BPN14770 or placebo.   "
48663|NCT02648659|"     This study assessed the effect of tailored eradication therapy according to Clarithromycin     resistance in Helicobacter pylori patients.   "
48664|NCT02648646|"     Purpose: To report the feasibility and to obtain preliminary data on the effects of using an     enhanced Otago Exercise Programme to reduce fall risk in individuals with osteoarthritis     (OA).      Participants: Ten participants from the Johnston County Osteoarthritis Project who have OA,     are at risk for falls, and are 65+ years old.      Procedures (methods): All participants will receive the 6-month enhanced Otago program. The     investigators will assemble data: quantifying participant adherence to and safety of the     intervention, ascertaining retention of participants for 6 months, determining acceptability     of the program, and other validated measures (e.g., number of falls and fall severity,     balance measures).   "
48665|NCT02648633|"     The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic     agent nivolumab given in combination with gamma knife therapy and valproate in patients with     recurrent glioblastoma, a common and lethal type of brain cancer.   "
48666|NCT02648620|"     PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and     functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with     symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and     popliteal arteries. The trial will enroll up to 15 subjects.   "
48667|NCT02648607|"     Pelvic girdle pain (PGP) during pregnancy occurs in approximately 70% of females and 38% of     women continue to suffer PGP symptoms beyond 12 weeks following delivery. PGP post- partum     causes pain during everyday activities that impacts negatively on health related quality of     life and is associated with significant healthcare and societal costs. These women are often     referred to physiotherapy, however management is difficult and there is a weak evidence base     for its management.      Alongside the provision of advice and information, physiotherapists commonly prescribe     orthoses such as a rigid belt with the aim of optimising pelvic stability and reducing pain.     More recently a novel customised Dynamic Elastomeric Fabric Orthosis has been developed as an     alternative to an 'off the shelf' pelvic belt. No studies have investigated their     effectiveness in complementing standard physiotherapy advice and management.      We will undertake a comprehensive systematic review of the literature to critically evaluate     the evidence base for the conservative management of chronic post-partum PGP. This will     inform a single case experimental design. Here eight AB single case studies will be performed     with the point of intervention being randomised between subjects. The use of a randomisation     test permits subsequent statistical analyses of group effects. Participants' pain, activity     levels, and quality of life will be evaluated along with subjective changes in confidence and     urinary incontinence. Adherence to orthosis use will be diarised. Exit interviews will assess     aspects such as the appropriateness of the outcome measures and acceptability of the     intervention that will help to inform future clinical trials.   "
48668|NCT02648594|"     When patient presents a lung node, there is an important risk that this node was a tumor. For     patients who have these nodes, the surgery is the best treatment. When the surgery is     possible, the thoracoscopy may be more advantageous compared to thoracothomy (decrease of     post surgery pains, decrease of recovery time and decrease of drugs consumption).     Nevertheless, thoracoscopy needs specific materiels and nécessite un équipement spécifique     and trained physicians.      Moreover, this technic needs that nodes was well localized. For this, radiologists use     CT-guided hook wire localization of these lung nodes before surgery.      TThe hook wire laying is delicate. It can lead secondaries effects as pneumothorax,     dislodgement of the hook wire before and after surgery. The success rate of hook wire     fixation in lung near of the node is primary.      The main objective of our study is to assess the success rate localization of node in surgery     piece, that is to verify if the hook wire have allowed to localize the lung node in surgery     piece.   "
48704|NCT02648126|"     The purpose of this study is to determine occurrence of pure red cell aplasia in a group of     participants with chronic renal insufficiency and with resistance criteria to epoetin alfa     treatment.The investigational product is producted by Bio-Manguinhos / Fiocruz (BIO-EPO) and     it is provided by the Unified Health System.   "
48670|NCT02648568|"     The aim of the study is to compare the benefit of two cognitive therapies in severe     sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric,     double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking     (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video     polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a     medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and     systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and     suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to     the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated     controls. Randomized patients will receive the therapy on day 1, and be monitored during the     subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored     again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires.     They will also complete the questionnaire by phone on Month 3. The non-randomized controls     will complete the questionnaire on month 1, with no therapeutical intervention between Day 1     and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by     the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the N3     awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night 28     (long term effect), as well as changes in sleep quality and sleepiness scales. A comparison     of spectral EEG, as well as respiration, eye movements, muscle tone and heart rate during     rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.   "
48671|NCT02648555|"     Embryo adhesion and placentation depend on tissue plasminogen activator (tPA)-mediated     activation of brain-derived neurotrophic factor, vascular endothelial growth factor and other     growth factors, formation of hemidesmosomes, and degradation of extracellular matrix and     basement membrane, either directly or by activating matrix metalloproteinases.      Since glucose and insulin stimulate release of a major tPA inhibitor by endothelial cells -     plasminogen activator inhibitor (PAI)-1 - the investigators hypothesized that lifestyle     interventions proven effective in maintaining glucose and insulin levels within the normal     range would increase the take home baby rate in women undergoing assisted reproduction.   "
48672|NCT02648542|"     This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial     direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS,     tDCS, and the combination of the two to assess the effectiveness of the treatment.   "
48673|NCT02648529|"     This project intends to investigate children with idiopathic and cryptogenic localization     related epilepsies, using a longitudinal assessment of structural and functional MRI data, in     relation to neuropsychological evaluation. The rationale is primarily based on: 1) the     frequent observation of selective cognitive dysfunctions in such children, the     pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI     investigation of brain maturation showing striking age and region dependant patterns.      The primary hypothesis is that some children with localization related epilepsies suffer from     altered maturation in the epileptic brain regions, and that this abnormal maturation affects     their cognitive abilities. 100 children with localization related epilepsies and 100 matched     controls will be prospectively enrolled during the first two years of the disease (for     patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once     a year for 5 years. The brain maturation of these children will be longitudinally assessed     using structural and functional MRI, and correlated with neuropsychological data.     Investigators hope to demonstrate that children with localization related epilepsies and     cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the     epileptic activity and the altered cognitive processes. The finding could partly bridge the     gap between these two abnormalities and help better understand their interaction and     respective dynamic. Once validated, the study of regional brain maturation in children with     epilepsy might be further used as a reliable surrogate marker or predictor of associated     cognitive dysfunction.   "
48674|NCT02648516|"     Combination antiretroviral therapy (ART) effectively suppresses viral replication, leading to     a significant immune recovery and a dramatic reduction in the incidence of AIDS-defining     events. However, approximately 20% of individuals who exhibit stable viral suppression by     ART, but fail to achieve sufficient immune reconstitution and are considered immune     nonresponders (INRs). These INRs often experience an increased risk of opportunistic     infections and shorter life expectancy compared with matched immune responders.Therefore,     efficiently treating these immune nonresponders has become one of the most difficult     challenges in the clinic.   "
48675|NCT02648503|"     Single center, prospective, randomized, single blinded, parallel group and controlled,     assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex     versus Standard of care on Quality of recovery in patient undergo elective laparoscopic     cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40),     one(D1) and three(D3) days after surgery   "
48676|NCT02648490|"     This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose     (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer     who have failed standard therapy and deemed unamenable by conventional therapy. This study     will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor     effect of HLX07 and explore the potential prognostic and predictive biomarkers.   "
48677|NCT02648477|"     This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works     compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane)     in treating patients with triple-negative or hormone-receptor positive breast cancer that has     spread from the primary site (place where it started) to other places in the body.     Pembrolizumab is an antibody drug that blocks a molecule called programmed death (PD)-1. PD-1     is a molecule that shuts down the body's immune responses and prevents the immune system from     attacking the cancer. Doxorubicin hydrochloride is a drug used in chemotherapy that works to     stop the growth of tumor cells by stopping them from dividing and by causing them to die.     Anti-estrogen therapy, including anastrozole, letrozole, and exemestane, lowers estrogen     levels in the body, which may help treat cancer that is hormone receptor-positive. Giving     pembrolizumab together with standard treatment of either doxorubicin hydrochloride     (triple-negative cancer) or anti-estrogen therapy (hormone receptor-positive cancer) may be     an effective treatment for these types of breast cancer.   "
48682|NCT02648412|"     The aim of the study was to describe the relationship between the intensity of a standardized     tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine     sedation.      After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every     minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the     stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured     before and after each stimulation.   "
48683|NCT02648399|"     This study recruit the patients with unilateral papillary thyroid cancer before operation,the     patients agree to enter the test,and divided into experimental and control group.experimental     group patients receive the surgery including unilateral thyroid lobectomy and bilateral     central lymph node dissection.and control group receive the surgery including unilateral     thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare     numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic     lymph node,and numbers of participants with adverse events related to treatment between two     groups in order to evaluate the significance of bilateral lymph node dissection.   "
48684|NCT02648386|"     Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer     treatment. The purpose of this study is to assess the safety and efficacy of autologous bone     marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem     cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile     dysfunction after rectal cancer treatment.   "
48685|NCT02648373|"     The purpose of this study is to evaluate patients with low back pain who are scheduled to     begin physical therapy but have not yet had their first appointment to better understand     their beliefs and attitudes and to evaluate the effects of an educational session about low     back pain.   "
48686|NCT02648360|"     Hispanics share a disproportionate burden of several of the nation's leading chronic diseases     caused by poor lifestyle habits such as sedentary behavior and poor quality nutrition intake.     This project will design, implement and evaluate the delivery and effectiveness of an     existing health promotion text messaging program focused on increasing physical activity and     improving dietary behaviors among medically underserved Hispanic patients. Adult Hispanic     patients referred by their healthcare provider at a local free community health clinic will     be invited to participate in the 4-month long study. Patients who agree to participate will     be sent health promotion text messages and will complete a brief pre-post assessment battery.     Patients who do not send an initial enrollment text (to agree to participate) will receive a     follow up telephone call from the research team to encourage participation. Evaluations will     consist of: (1) physician referral rates; (2) patient enrollment rates; (3) demographic     differences (gender, age) in participants/non-participants; and (4) pre-post changes in     levels of physical activity and quality dietary intake will be conducted. The results of this     study will provide a better understanding of the feasibility and effectiveness of     implementing referral-based text messaging programs among medically underserved Hispanic     patients at high risk for chronic diseases.   "
48688|NCT02648334|"     This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA)     using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral     Artery disease.   "
48689|NCT02648321|"     The purpose of this study is to determine whether motivational intervention is effective in     promoting exercise habit in patients with psychosis.   "
48690|NCT02648308|"     Results from the 5As Team (5AsT) Study have identified critical gaps in medical school     curricula on obesity, leading to a wave of new family physicians who are unconfident and     poorly equipped to manage obesity with their patients. In an effort to address this gap, all     first year medical residents training in family medicine at the University of Alberta during     the 2015/2016 year will be required to take a 2 day workshop in Obesity Management as part of     the Doctor-Patient Relationship Course. The workshop will focus on knowledge, intangible     skills and practicing the 5AsT approach to obesity management with patients of all     demographics. The objective of the 5AsT MD2 study is to evaluate the impact of this workshop     on the residents' attitudes and beliefs about obesity, as well as their level of confidence     in using key aspects of the 5As of obesity management to help their patients. Participants     will be asked to complete and submit pre- and post- knowledge assessments, narrative     reflections and questionnaires assessing their beliefs and attitudes towards people living     with obesity as part of their core requirements for the course. For those who consent to     participate in the study and release their de-identified course assignments, we will evaluate     the impact of the workshop using both quantitative and qualitative methods. The results will     assist us in gaining information that may help us improve and further refine curricular     materials for physicians and medical trainees.   "
48691|NCT02648295|"     Blood management is an important part of successful total joint replacement. Loss of blood     and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has     become a standard component to many blood management programs. It is used to treat or prevent     excessive blood loss during surgery and in various medical conditions such as excessive     bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from     growing and causing problems. When this process becomes overactive it can result in excessive     bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the     relationship between TXA and thromboelastogram (TEG) results.   "
48692|NCT02648282|"     This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody     that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused     radiation) is effective (anti-tumor activity) and safe in patients with locally advanced     pancreatic cancer.   "
48693|NCT02648269|"     This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose     of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid     levels. This will be followed, in separate subjects, by evaluation of the safety,     pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of     SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid     levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is     then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from     forming.   "
48694|NCT02648256|"     Pneumocystis jirovecii pneumonia is a serious and frequent infection in immunocompromised     patients, whose evolution is potentially fatal if untreated. It is the most common     opportunistic infections classifying patients infected with human immunodeficiency virus     (human immunodeficiency virus +) at the stage acquired immune deficiency syndrome. Data from     the french Institute for Health Watch showed in 2011 that 31% of 1400 cases of acquired     immune deficiency syndrome were revealed by Pneumocystis jirovecii pneumonia.      Pneumocystis jirovecii pneumonia also increasingly concerns immunocompromised human     immunodeficiency virus negative patients, due to the increasing use of immunosuppressive     therapies (including corticosteroids), of anticancer cytostatics and biotherapies, in the     context of grafts, transplants, but also from autoimmune or inflammatory chronic diseases.      Recent data show that the number of cases occurring in patients Pneumocystis jirovecii     pneumonia human immunodeficiency virus - in France is now higher than the cases occurring in     Pneumocystis jirovecii pneumonia +. The severity of the Pneumocystis jirovecii pneumonia is     increased in patients with human immunodeficiency virus -, in whom the evolution is faster,     with mechanical ventilation often required and higher mortality, requiring a fast and early     diagnosis. Routine diagnosis relies on the detection of the fungus in the bronchoalveolar     lavage, using stains (May Grunwald Giemsa or immunofluorescence) and Polymerase Chain     Reaction. Polymerase Chain Reaction provides a diagnostic gain in immunocompromised patients     not infected with human immunodeficiency virus that may present a pejorative table quickly     despite low fungal burden. However, the deoxyribonucleic acid of the fungus can sometimes be     detected in the absence of scalable Pneumocystis jirovecii pneumonia, and then shows a     pulmonary colonization by Pneumocystis jirovecii. It is therefore important to improve the     positive predictive value of Pneumocystis Polymerase Chain Reaction, to guide the management     of optimal patient.      In this work, the investigators propose to evaluate the Polymerase Chain Reaction on     oropharyngeal rinse, non-invasive sampling and therefore probably less often positive and     specific active infection. The investigators will develop a quantitative Polymerase Chain     Reaction to identify a fungal load threshold number of copies / mL for diagnosing     Pneumocystis jirovecii pneumonia with better positive predictive value.   "
48695|NCT02648243|"     In Qatar, cardiovascular diseases (CVD) have become the leading cause of morbidity and     mortality over the past two decades. Between 1991 and 2010, a total of 16,736 patients were     admitted with ACS (Acute Coronary Syndrome) in Qatar. Despite the use of percutaneous     coronary intervention (PCI), coronary artery bypass graft (CABG), and pharmacological agents     to acutely reduce vascular risk, ACS patients are at high risk of having further     cardiovascular events. Consequently, secondary cardiovascular risk reduction therapy is     needed for all CAD (Coronary Artery Disease) patients. Clinical practice guidelines recommend     that following ACS, patients should receive indefinite treatment with aspirin, a beta     blocker, an angiotensin converting enzyme inhibitor (ACEI) or alternatively angiotensin II     receptor blocker (ARB) and a statin. Less than 80% of ACS patients in Qatar use this     quadruple combination after discharge. This creates a significant opportunity for pharmacists     to improve CVD management and outcomes in Qatar. Nothing is known about the impact of Qatar     clinical pharmacists as direct patient-care team members at discharge and post-discharge on     the short-term and long-term outcomes of ACS patients. The proposed study is aimed to     determine this impact. The investigators hypothesize that a clinical pharmacist-delivered     intervention consisting of medication reconciliation and counseling at discharge and tailored     follow-up post-discharge will decrease hospital readmissions, emergency department (ED)     visits and all-cause mortality at 3 month, 6 months and 12 months after hospital discharge     when compared with control arm and pharmacist delivered intervention at discharge only among     ACS patients. The investigators also hypothesize that the effect of the intervention will     increase patients' adherence to evidence-based secondary prevention medications for CAD     (Coronary Artery Disease), and patient satisfaction with pharmacy services. Besides, this     intervention will reduce the treatment burden on patients.   "
48696|NCT02648230|"     The model by which physicians measure the lack of blood flow in the vessels that supply blood     to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the     pressure across the vessels that supply blood to the heart. These are known as the coronary     arteries. This study involves comparing two FFR wires, the St. Jude Medical Pressure Wire     (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the devices. FFR allows     real-time estimation of the effects of a narrowed vessel, whereas standard angiography can     underestimate or overestimate narrowing, because it only visualizes contrast (the different     areas of color) inside a vessel.   "
48697|NCT02648217|"     This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and     safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily     in subjects with type 2 diabetes mellitus before, during and after Ramadan.   "
48698|NCT02648204|"     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of     this trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on     to metformin in subjects with type 2 diabetes.   "
48699|NCT02648191|"     Faced with the current obesity epidemic, new avenues of research into effective weight loss     must be developed.      Among the possible actions on obesity, vagus nerve stimulation has been shown in several     studies to be effective in treating epilepsy or depression, at the same time inducing weight     loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss     in experimental animal studies. Vagus nerve stimulation has never been attempted in obese     patients awaiting bariatric surgery.   "
48700|NCT02648178|"     This study will test feasibility, in smokers with lung, head & neck, and bladder cancers,     that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity     and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes     compared to regular combustible cigarettes.   "
48701|NCT02648165|"     Depression (major depressive disorder; MDD) is a very common mental disorder. Research     suggests that individuals with prior depressive episodes have a risk of the relapse or     recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term     management of the disease. The current project aims to investigate whether group based     Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse     in a group highly vulnerable to depressive episodes. The group intervention will consist of     eight sessions, and each group will consist of maximum 12 persons. The project also studies     whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the     effect. ABM will be administered over a fourteen days period prior to the ACT-intervention.     Effect will be measured over a period of 12 months. The primary outcome is changes in     depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects with     a history of major depression (n=200), currently in remission, will be recruited from     Sørlandet Hospital (100 participants). Matched participants (100 participants) will be     recruited at the University of Oslo. In the first phase, participants from Sørlandet hospital     will be randomized to ABM treatment or control condition. In the second phase all     participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT     and ABM represent interventions that are time and cost effective, and that could be made     available to large number of individuals struggling with MDD.   "
48702|NCT02648152|"     Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant     in terms of radiographic, clinical performance and long-term survivorship.   "
48703|NCT02648139|"     In the present randomized, controlled, double-blind clinical trial, we investigated the short     term clinical efficacy of a dentifrice containing Eugenia uniflora L. ripe fruit extract in     preventing gingivitis in children.   "
48705|NCT02648113|"     Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting     in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there     is an international consensus on the urgent need for a randomized trial.      The investigators hypothesize that a restrictive transfusion strategy is at least     non-inferior to a liberal transfusion strategy on 30-day outcomes of MI patients with     anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility     analysis becomes key to determining the role of each strategy.   "
48706|NCT02648100|"     Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and     no target therapies for this pathology are currently validated. By 40 gene expression     signature realized on frozen samples, we have previously identified an aggressive sub-class     of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro     and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation     suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim     is to establish a standard diagnostic tool to differentiate the basal subtype of bladder     cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial     (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR     associated chemotherapy.   "
48707|NCT02648087|"     There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia     in perturbation of quality of life and tumour progression to patients with a bronchial     cancer.      The aim of the study is to evaluate this possibility with the help of a night record of sleep     and quality of life questionnaires.   "
48708|NCT02648074|"     Asthma is a chronic, inflammatory disease of the lung characterized by intermittent airway     obstruction, airway hyperresponsiveness, presence of activated inflammatory cells,     inflammatory mediators, and airway structural changes. Airway smooth muscle (ASM) cells     actively participate in the remodelling and inflammatory processes through proliferation,     release of proinflammatory cytokines, chemokines, and extracellular matrix (ECM) proteins.     Eosinophils as essential inflammatory cells may be of importance in ASM remodelling. It is     known that eosinophil induces ASM cells proliferation via the secretion of cysteinyl     leukotrienes in asthmatics. However there is a possible direct eosinophil-ASM cells     functional interaction by adhesion processes. It has been shown that integrins modulate ASM     proliferation and contractile protein expression demonstrating allergen-induced ASM     remodelling in an animal model of allergic asthma.      Wingless/integrase-1 (WNT) signaling regulates not only a wide range of developmental     processes, but its aberrant activation can lead to disease. Recently, it was confirmed that     genes polymorphisms in the WNT signaling pathway are associated with impaired lung function     in childhood asthma. It was also found for the first time a relevant role of noncanonical WNT     signaling in TGFβ-induced ECM expression by ASM cells and identified WNT-5A is the most     abundant WNT ligand with increased expression in asthmatics. It demonstrates that WNT-5A     could contribute to remodelling of the airways. Unfortunately, the effect of eosinophil on     WNT secretion by ASM cells at present is unknown.      Despite the widely acknowledged significance of eosinophils in asthma pathogenesis, the     mechanism of eosinophil induced ASM remodelling is unsolved.   "
48709|NCT02648061|"     Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of     successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall     prognosis after ROSC has not improved much and the in-hospital mortality is still reported to     be 50 to 70 %. The post-resuscitation disease is now called the post-cardiac arrest     syndrome (PCAS) and comprises 1) brain injury, 2) myocardial dysfunction and 3) systemic     ischemia and reperfusion.      Treatment of patients after cardiac arrest has often followed guidelines that were primarily     developed for treatment of septic shock. It is still uncertain whether this is the optimal     way to deliver circulatory support after cardiac arrest.      There is a lack of studies assessing the relationship between the inflammatory response     measured by inflammatory biomarkers and circulatory failure in PCAS.      In this study a detailed description will be given of the clinical trajectory of the     circulation and the inflammatory response during the first 5 days after cardiac arrest, and     it will be investigated whether patterns of circulatory and inflammatory response may be     predictive of deterioration of clinical state.   "
48710|NCT02648048|"     This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and     tolerability of vismodegib in combination with pirfenidone in participants with idiopathic     pulmonary fibrosis (IPF) currently being treated with pirfenidone.   "
48711|NCT02648035|"     The purpose of this study is to evaluate the percentage of participants treated with     subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that     play a major role in continuation of treatment.   "
48712|NCT02648022|"     To determine the effect of an integrated care protocol on antiviral treatment and sustained     virologic response (SVR) rates following initiation of direct acting antiviral therapies     (DAA) treatments in 2011.   "
48713|NCT02648009|"     The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the     health care system's most expensive diagnoses. Despite major advances in medicine, the     mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI)     is used for non-invasive imaging of the cardiovascular system to enable the structure and     anatomy of the organ to be visualized. However, current MRI methods have limitations when     assessing and aiding in the management of CHF. A new imaging method has recently been     developed that is showing great promise as a tool in the management of patients with CHF.     Rapid imaging of biochemical reactions within myocytes using MRI has recently become possible     through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method.     DNP-dissolution results in an intravenous contrast agent that is hyperpolarized, producing     a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13     labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human     heart, along with the required hardware and data acquisition methods.   "
48857|NCT02646137|"     Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In     recent years, transarterial chemoembolization, radio frequency ablation and microwave     ablation have been accepted as treatment modalities for patients with surgically unresectable     hepatocellular carcinoma.   "
48715|NCT02647983|"     Prostate cancer is the most common malignancy among men in the United States and Canada.     Suspicion of prostate cancer with modern screening tests, such as digital rectal exam (DRE)     and prostate serum antigen (PSA) require ultrasound-guided biopsy for pathological diagnosis.     However, this technique misses cancer in nearly one quarter of patients and finds clinically     insignificant disease in another third of patients, resulting in over-treatment and     unnecessary morbidity.      MRI is the best imaging method for prostate cancer detection, but current techniques cannot     reliably predict tumour grade and are often unreliable for localizing cancer, particularly     within the transition zone, where specificity is low. The primary objective of this pilot     study is to evaluate the added benefit of localizing prostate cancer and predicting tumour     grade with Hyperpolarized 13C MRI, in addition to traditional T2-weighted and     diffusion-weighted MR imaging.      The investigators propose a pilot study, in men diagnosed with prostate cancer awaiting     prostatectomy, with the specific goals of comparing pre-operative imaging findings to ground     truth histology, using whole-mount prostate specimens. The results of this study will provide     insight into the prostate cancer disease signatures with MRI and determine if there is added     benefit for incorporation of this new technique into future clinical MRI protocols. If future     imaging tests could determine the size, grade and extent of disease, this would open the door     for less invasive, localized treatment options with reduced morbidity.   "
48716|NCT02647970|"     The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1)     activity through dietary interventions can increase energy metabolism in humans.   "
48717|NCT02647957|"     Code Stroke is a system for the rapid identification, pre-notification and transport of acute     ischemic stroke patients. The objective of this study was to define quality indicators and to     compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals     without the use of Code Stroke (control patients).   "
48718|NCT02647944|"     Obesity is associated with differences in stomach function, feeling of fullness after meals,     and total calories consumed at a buffet meal. Based upon previous research, our study     hypothesis is that weight loss with pharmacological agents may be individualized, based on     the abnormality in those gastrointestinal functions. These studies will provide support for     the principle that specific obesity medications should be selected according to individual     characteristics, and it is anticipated that this approach will enhance efficacy of medication     treatment of obesity.   "
48719|NCT02647931|"     Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient     population with reported dysphagia who exhibit normal oropharyngeal and esophageal swallowing     function as evidenced by videofluoroscopic swallow study. These patients also demonstrate     abnormal supraglottic muscle tension during laryngoscopy as well as signs of laryngeal     hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with Proton Pump     Inhibitor (PPI) therapy is a common practice however voice therapy invention targeting the     unloading of the supraglottic muscle tension has been shown to be highly effective in symptom     resolution per the investigators' clinical experience. The study is designed to answer     efficacy of treatment being offered to patients with muscle tension dysphagia.   "
48720|NCT02647918|"     The purpose of this study is to evaluate the effect of mild, moderate, or severe renal     impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and     tolerability of 1 or 2 single doses of sotagliflozin compared with healthy,     demographically-matched subjects with normal renal function.   "
48721|NCT02647905|"     The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics     Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with     reference standard measurements The investigation will also evaluate safety of the Senseonics     CGM System usage.   "
48722|NCT02647892|"     The purpose of this study is to determine the optimal amount of lidocaine buffering needed to     decrease injection pain when administering local anesthesia.   "
48723|NCT02647879|"     The main aim of this study is to test in the Icelandic population the hypothesis that a     nationwide treatment program which offers effective treatment to all known cases of Hepatitis     C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in     incidence and disease burden associated with chronic HCV infection.   "
48724|NCT02647866|"     The purpose of this study is to determine the safety and tolerability of administration of     multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with     moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE)     phase for eligible subjects with a clinical response.   "
48725|NCT02647853|"     This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested     the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4     Gel administered once daily to 50 cm2 of skin for 14 days.   "
48726|NCT02647840|"     This study wants to investigate treatment for patients with common voice disorders where no     surgical or medical treatment is needed. A voice disorder is when your voice is croaky,     hoarse or when you lose it altogether. This can be a serious problem for people as it stops     them from participating in their normal life (for example in their jobs, hobbies, family and     wider social life).      This study will look at our most commonly used method of treatment for voice problems. This     method is based on physical exercises which work on the muscles which produce the voice. This     voice work was originally developed by Jo Estill, a singer and scientist, and is widely used     in voice coaching. Though many Speech and Language Therapists (SLTs) provide voice therapy     based on the Estill model, there is no clinical evidence to support its use.      The aim of this study is to test the design for a larger research study into the effects of     voice therapy based on Estill model of voice. We want to find out if our tests work and are     easy to use, and to check that the study methods are right and would work on a larger scale.     It is a feasibility study, and therefore allows us to test whether this study can be done.     Another important part of this study is to involve patients in developing research. We want     to find out what patients think about the treatment they receive, and about taking part in a     study.      The way this study will work is that patients who have agreed to take part will have between     four and six voice therapy appointments, just like they would if they were not part of the     study. Voice test results from before and after treatment will be compared and carefully     studied. After patients taking part in the study have finished their treatment, they will be     asked about their experience of voice therapy, and of being in the study. Much of what will     be done as part of the study is identical to what is normally done in treatment, however we     will look in detail at all the tests, and we need permission from participants to use their     test results and include their comments.      It is important to learn more about voice therapy and to improve voice therapy for patients     with this type of voice problem. By finding out more what patients think about the treatment     we provide, what tests to use, and about how best to run a research trial, we will be able to     plan further research and hopefully be successful at a next large research grant application.   "
48751|NCT02647515|"     To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the     treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular     glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing     postoperative intraocular pressure（IOP）control.   "
48727|NCT02647827|"     The hypothesis is that acupuncture is equally effective as metformin (both treatments     combined with lifestyle management) in improving whole body glucose homeostasis in insulin     resistant women with polycystic ovary syndrome (PCOS), and that both are superior to     lifestyle management alone. The investigators hypothesize that acupuncture and metformin     induce ovulation and improve hyperandrogenism, as well as health related quality of life     (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and     metformin), the investigators hypothesize that acupuncture is associated with less negative     side-effects. The investigators also hypothesize that these treatments have the potential to     restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and     skeletal muscle tissue) and thus have the potential to prevent the development of type 2     diabetes (T2D).   "
48728|NCT02647814|"     Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a     parent support intervention consisting of periodic text messages and educational support     (video, collateral materials),and usual care on the healthcare engagement of limited English     proficient (LEP) Latino parents during their child's first year and to examine its impact on     healthcare utilization and primary care quality.   "
48729|NCT02647801|"     The aim of this trial is to test a novel network approach (Bringmann et al., 2013), which     enables to investigate the complex, interdependent network of self-control and its influences     in everyday life. By adding an intervention to the network, such as mindfulness training, it     is also possible to explore the way mindfulness changes connection strengths between network     variables.      For six weeks, an ambulatory assessment and additional seven weekly laboratory sessions are     conducted with 120 students from the Johannes Gutenberg University Mainz who are randomized     to a control (n=60) or intervention condition (n=60). Pre and post measurement sessions take     place to assess self-reported trait self-control and mindfulness and a behavioral measure of     mindfulness (Levinson, Stoll, Kindy, Merry & Davidson 2014). Participants of both the     experimental and control condition come to five weekly lab meetings in which they fill out     questionnaires to assess changes in self-reported self-control and mindfulness. But only     participants of the experimental condition take part in weekly computer based mindfulness     trainings. During the ambulatory assessment, participants complete questionnaires six times a     day via mobile phones that are randomly prompted and answer questions about state     self-control, motivation, affect, and current situation.   "
48730|NCT02647788|"     The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen     (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after     hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.   "
48731|NCT02647775|"     Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been shown     to reduce postoperative discomfort, and has improved cosmetic results when compare to open     thoracotomy. The specific aims of this project are: to clarify the physiologic and     immunologic effects of different approaches for minimally invasive thoracic surgery: (1)     multiple-port VATS; (2) single-port VATS   "
48732|NCT02647762|"     This trial will test the hypothesis that the administration of CF101, a novel     anti-inflammatory agent, to patients with rheumatoid arthritis will relieve signs and     symptoms of the disease. CF101 effect will be in comparison to MTX in this study population.   "
48733|NCT02647749|"     This current care protocol follows the biomedical research protocol entitled Non-invasive     mapping of the heart ECG high amplification that demonstrated the clinical value of     noninvasive Cardioinsight® mapping system.      Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of     cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of     serious arrhythmias or sudden death, with the currently used non-invasive mapping routine.     The results obtained with non-invasive mapping will be compared with those obtained with the     conventional method without non-invasive mapping.   "
48734|NCT02647736|"     Kinetics of Copeptin in response to osmotic alterations in healthy volunteers   "
48735|NCT02647723|"     The purpose of the study is to test whether nutritional supplementation during pregnancy is     associated with 1) improved maternal health during pregnancy; 2) improved infant birth and     neurodevelopmental outcomes, and 3) whether the association between nutritional     supplementation during pregnancy and infant outcomes is partially mediated by reductions in     maternal perceived stress and stress reactivity during pregnancy.   "
48736|NCT02647710|"     PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for     recently-arrested juvenile offenders on probation. The program will teach teens about     HIV/AIDS, sexually transmitted infections, and safer decision-making. The PHAT Life Research     Study is a 2-arm randomized controlled trial of the PHAT Life Intervention. The investigators     will test and compare PHAT Life to the health promotion control group on adolescent risky     sexual behavior, substance use, and theoretical mediators.   "
48737|NCT02647697|"     To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy     adult subjects.   "
48738|NCT02647684|"     The purpose of the study is to assess the characteristics of parents who enroll in parenting     interventions and to assess the utility and efficacy of a self-directed Triple-P intervention     for parents of children with a diagnosis of cancer. The study aims to recruit parent(s) or     primary caregiver of children with a diagnosis of cancer.Participants will be parents of     children aged between 3-10 years who have had a diagnosis of cancer for 6 months or more.     Recruitment will take place nationally via cancer voluntary groups/charities and other     relevant organisations. The project will be advertised through these organisations and their     various media outlets such as newsletters and social media pages (e.g. Facebook). All data     collection will take place online. Following completion of the initial survey, parents will     have the option to opt in to a case series whereby 10 parents will have the opportunity to     receive the Triple P Every parents self- directed workbook to complete over 10 weeks.   "
48779|NCT02647151|"     Photodynamic therapy technique (PDT) is a conventional technique which is performed applying     the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a     light source, usually red.      The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with     MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The     pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and     consequently it is more effectively.   "
48739|NCT02647671|"     In the proposed study, investigators will conduct a 90-day dietary intervention study in     human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be     randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a     comparable level of calcium alone. There will also be a placebo group. Prior to ingesting the     study agents and following the course of treatment, colonic biopsies will be obtained by     sigmoidoscopy and quantitatively examined for markers of growth and differentiation. In this     study, metabolomic and microbial profiles will also be generated from fecal and colon mucosal     samples taken at baseline and study endpoint.   "
48740|NCT02647658|"     Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be     self-limited (acute), but some people can progress to a state of persistent pain. Often     termed chronic LBP (cLBP), this condition can cause prolonged difficulty with most daily     activities, including job performance. Most patients see chiropractors or primary care     physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for     preventing patients with acute LBP (aLBP) from developing cLBP. Both treatments can be     delivered in an outpatient PCP setting. The first approach is to provide PCPs with     information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage     PCPs to treat patients according to accepted clinical guidelines. The second approach is to     provide the same risk information and have PCPs team up with physical therapists to deliver     psychologically-informed physical therapy (PIPT) for those patients determined to be at high     risk for transitioning to cLBP. PIPT is designed to help patients identify and overcome     physical and psychological barriers to recovery. The 3,000 patients expected to be recruited     from five regional sites (Pittsburgh, PA; Boston, MA; Baltimore, MD; Charleston, SC; and Salt     Lake City, UT) will start the study when their LBP is in an acute phase. The study's primary     aims are to compare the proportions of cLBP and measures of functional ability between the     two groups at 6 months. Secondary aims are to compare these outcomes between the two groups     at 12 months and measure the number of low back-related x-rays, MRIs, surgeries, and other     medical procedures during the follow-up period. The same outcomes will be assessed for an     observational cohort of 9,000 patients with aLBP at low to medium risk for transitioning to     cLBP across the 5 sites. This study was designed with input from a variety of national and     local stakeholders, including patients with LBP, providers, payers, professional     organizations, purchasers, and policy representatives.   "
48741|NCT02647645|"     The purpose of this study is to develop pilot data on the potential efficacy of     computer-based cognitive training or the combination of computer-based cognitive training     with transcranial direct current stimulation (tDCS) in improving cognitive function in     persons with HIV-related mild neurocognitive disorder (MND). tDCS is a noninvasive brain     stimulation technique in which a small direct current (1-2 mA) is applied to the scalp during     a cognitive or motor activity, inducing a very small current that affects specific neural     circuits related to the site at which electrodes are placed. tDCS has been judged safe and     has shown significant treatment effects in studies with other populations, but has not been     extensively studied in individuals with HIV infection. tDCS has been shown to facilitate     learning in a number of studies, suggesting that it may improve or enhance learning in those     with cognitive problems. As HIV infection is associated with decrements in a number of     cognitive skills, including working memory, executive functions, and psychomotor speed that     are related to individuals' functional status and medication adherence, the demonstration of     a technique to enhance the effects of cognitive training in this population would have     substantial clinical benefits as well as scientific value.   "
48742|NCT02647632|"     The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients     who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with     Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the     rate of sustained virological response (SVR) 12 weeks after 16 or 24 weeks of this treatment.     SVR12 is defined as HCV RNA < LLOQ (either TD[u] or TND).   "
48743|NCT02647619|"     Aim:      Clinical RCT comparing functional results and recurrence rate following enzymatic treatment     vs. needle aponeurotomy.      Materials and methods:      30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the     three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint.     Patients with primary disease of the hand. Total of 80 patients needed to detect difference     of 13.5°.      1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks,     16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ,     VAS pain and VAS patient satisfaction. Total passive extension contracture reduction,     recurrence rate and registration of complications.   "
48744|NCT02647606|"     Videolaryngoscope is useful to improve the laryngeal view, especially during difficult     intubation. There are several kinds of videolaryngoscopes and it is applicable during     nasotracheal intubation. In this study, the investigators will compare the McGrath     videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in     patients with manual in-line stabilization.   "
48745|NCT02647593|"     Laboratory change induced by common bile duct (CBD) stone is in general observed as the     higher elevation of alkaline phosphatase (ALP) and gamma-glutamyl transpeptideas (ɤ-GT), in     comparison to those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT).     However, some patients with CBD stone show the marked increased level of aminotransferase,     which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis,     ischemia, and drug toxicity. The aim of this study is to investigate the clinicopathologic     features of patients with CBD stones with the high level of aminotransferase in serum.   "
48746|NCT02647580|"     Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and     thus, a sign of undernutrition. This study will include children with FTT, and compare with     existing data from children with normal and excessive growth.      The overall aim of this study is to explore whether 1) children who develop FTT with no     organic explanation differ from healthy normal weight and overweight children in their basal     level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in     children can be partly predicted by variation in their gut microbiome and metabolome.   "
48747|NCT02647567|"     Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant     properties, and their intake when in moderate doses seem to produce positive effects on     stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be     displayed also on cognition, as caffeine, when in proper proportions, the investigators do     not know if the joining of the two strategies into a single activity would be able to promote     additional effects enhancing cognitive processes related to memory, attention, and motor     reaction time.   "
48748|NCT02647554|"     A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of     Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China   "
48752|NCT02647502|"     Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of     multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also     associated with less severe disease in mice who do develop the disease. Currently, whether     these results translate favorably in humans is unknown. This is a pilot trial of testing two     caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one     continuous caloric restriction (CR) diet where a small number of calories will be restricted     every day or another intermittent CR diet where a caloric intake will be restricted more     severely 2 days per week. Participants are randomized to one of the diets, and for the first     8 weeks, will receive standardized, prepared meals tailored to the specific diet. At the     conclusion of the controlled feeding study, all participants will transition to an unblinded     phase for an additional 40 weeks where they are provided with instructions to follow an     intermittent CR diet.   "
48753|NCT02647489|"     Despite having developed robust acquired immunity against complications of malaria, women can     return to a susceptible state during their first pregnancies and contribute significantly to     the burden of severe malaria in highly endemic areas. Naturally acquired protection against     placental malaria correlates with the presence of high concentration of immunoglobulin G     molecules (IgGs) against VAR2CSA, a parasite protein of the var gene family that is essential     for the binding of infected erythrocytes to CSA in the placenta.      To induce high concentrations of specific IgGs, subjects will receive escalating doses of     PAMVAC vaccine antigen adjuvanted with Alhydrogel, Glucopyranosyl Lipid Adjuvant-Stable     Emulsion (GLA-SE) or Glucopyranosyl Lipid Adjuvant-Liposome-QS-21 Formulation (GLA-LSQ).     Three injections with the same dosage and adjuvant will be done, each 28 days apart (Day 0,     28 and 56). Control subjects will receive physiological saline instead of the vaccine and     dose escalation will be staggered to ensure safety during the trial.   "
48754|NCT02647476|"     Immunomodulating enteral nutrition in the perioperative period may reduce postoperative     complications in cancer patients. Little is known if this effect translates to the better     survival.      The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition     on postoperative complications and survival of gastric cancer patients.      The group of 98 gastric cancer patients were randomly assigned for postoperative     immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral     nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year     and 5-year survival were analyzed.   "
48755|NCT02647463|"     Attachment and Biobehavioral Catch-up (ABC) is a manualized 10-session intervention delivered     in families' homes or other places of residence. By helping parents of infants provide     nurturance when their children are in distress, follow their children's lead, and behave in     non-frightening ways, the ABC intervention has been previously found to enhance children's     attachment quality and children's ability to regulate behavior, physiology, and emotions. The     purpose of the present study is to examine the effectiveness of ABC in the context of     community-based implementation efforts. Outcome assessments will include parent sensitivity,     attachment quality, and cortisol regulation. The investigators hypothesize that parents     randomly assigned to receive the ABC intervention will show higher levels of sensitivity at     follow-up than parents randomly assigned to the waitlist control condition; and children     randomly assigned to the ABC intervention will show higher rates of secure attachment and     more normative profiles of cortisol than children randomly assigned to the waitlist     condition.   "
48756|NCT02647450|"     An estimated 90,000 patients are suffering from long term gastrointestinal problems after     cancer treatments, and whilst the National Cancer Survivorship Initiative have been working     to develop specific pathways of care, these pathways lack in both specialised tariff funding     and awareness. This study aims to assess the economic and personal impact on patients     suffering from stomach and/or bowel problems after cancer treatment prior to referral to the     Gastrointestinal and Nutrition Team (GIANT) at the Royal Marsden Hospital. All patients     referred to the GIANT service (including private patients but excluding re referrals) will be     offered participation in the study.      The study will consist of a 9 page patient retrospective questionnaire, asking questions     about investigations and medications prescribed over the past year, as well as costs and     methods of trying to treat their symptoms themselves, and the personal cost to themselves of     their symptoms through loss of work and emotional impact. As this questionnaire asks patients     questions about the past year, and thus can be difficult to answer accurately, patient     answers will be validated for reliability by sending a 1 page questionnaire to their GP     asking the same questions about clinic visits concerning stomach/bowel problems,     investigations and medications prescribed in the past year. Once this data is collected from     the participants, and the study has finished, the average cost of clinical interventions,     economic impact, and personal impact, will be calculated.      The results from this study will be useful in helping to show the economic burden of GI     symptoms, and will provide evidence as to the economic benefit of specialised clinics for the     consequences of cancer treatment; highlighting the need for a nationally recognised algorithm     for management.   "
48780|NCT02647138|"     Many patients complain to clinicians that they have difficulty sleeping appears to be due to     environmental noise. There is a common perception that acute noises are more troublesome than     continuous noises in the effect on individual sleep quality. Therefore the goal is to use a     Marpac white noise maker with a continuous noise to see its effect on individuals that have     difficulty sleeping in a high noise environment.   "
48781|NCT02647125|"     This primary objective of the trial is to study whether the local control of Huachansu plus     thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with     esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be     recruited into the trial.   "
48782|NCT02647112|"     Clinical trial to determine the performance characteristics (sensitivity and specificity) of     the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.   "
48812|NCT02646722|"     Rocuronium results in burning pain on injection site. It can be reduced by local anesthetics     or opioid, but still some patients, especially in children, show withdrawal movement for     pain. This might resulted from individual pain sensitivity.      Emergence agitation (EA) in children is quite frequent postoperatively and is known to be     associated with postoperative pain. If a patient is susceptible to postoperative pain, he or     she would have high probability of EA postoperatively. Therefore, the investigators explore     the relation of withdrawal movement of rocuronium and EA.   "
48758|NCT02647424|"     Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies, affecting 5% to     10% of women of reproductive age. Women with PCOS suffer from anovulatory infertility.     Following lifestyle modification with weight reduction in obese PCOS women, clomifene citrate     (CC) is considered the first line treatment for ovulation induction (OI) in these women.     75-80% of women will ovulate after CC administration. However, there is a discrepancy between     the ovulation rate and pregnancy rate, which was reported to be 22% per each ovulating cycles     after CC. Other alternatives, including gonadotropin injections and laparoscopic ovarian     drilling, carried different disadvantages, such as costly treatment and risks of ovarian     hyperstimulation syndrome and multiple pregnancy rate in gonadotrophin therapy and surgical     risks and risk of ovarian failure in surgical treatment.      The use of aromatase inhibitor, letrozole (LTZ), in reproductive medicine started in 2001.     After this publication, there have been many groups of investigators studying the use of LTZ     either in OI or ovarian stimulation in IVF cycles. A large multicentre randomized trial     reported a significantly higher ovulation rate and live-birth rate comparing LTZ with CC. In     majority of the publications, the multiple pregnancy rate was lower in LTZ group than in CC     group. This can be attributed to the higher chance of monofollicular development after LTZ     compared with CC. However, there is no information comparing the hormonal profile and     follicular development after letrozole and CC.      Mild ovarian stimulation using LTZ or CC in conjunction with intrauterine insemination is     commonly offered to ovulatory women with unexplained infertility, minimal endometriosis or     mild factor to improve the pregnancy rate. There is again no information comparing the     hormonal profile and follicular development after letrozole and CC in ovulatory women.      The aim of this study is to compare the hormonal profile after the use of LTZ and CC in     anovulatory PCOS women and ovulatory women with unexplained subfertility. The hypothesis is     that the FSH risk after LTZ is shorter than that of CC.   "
48759|NCT02647411|"     The purpose of this study was to evaluate the increased prevalence of myopia among patients     in different periods in an ophthalmologic hospital in Goiania. There has been an increase of     myopia prevalence around the world especially in some Asian countries. The investigators     intend to analyze if this growing tendency is also present in our hospital, and if it exist     how much is this growth.   "
48760|NCT02647398|"     Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the     PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus     a supervised resistance program. The primary objective is improvement of cancer-related     fatigue.   "
48761|NCT02647385|"     The serratus anterior muscle plane (SAM) block associated with pectoral nerve block type I     (PEC I) may be a safe and effective alternative for the intraoperative of breast surgery,     since there is evidence of pain reduction. However, correlation between regional anesthesia,     postoperative pain and inflammatory response in breast surgery has not been demonstrated. The     aim of this study is to compare the standard intravenous analgesia versus systemic analgesia     associated with the SAM block and PEC I during breath cancer surgery. The following     parameters will be evaluated: consumption of opioid intra and post-operative; post-operative     pain and release of plasma inflammatory cytokines. It is a clinical prospective, randomized     and controlled study. 50 individuals will be randomly divided into two groups. A group of     patients receive general anesthesia during surgery and intravenous analgesia after the     surgery and another group will receive general anesthesia associated with SAM and PEC I block     during intraoperative and postoperative systemic analgesia. The postoperative pain will be     assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after     surgery. Blood sample will be collected for determination of serum cytokines before surgery     and 24 hours after the surgery.   "
48762|NCT02647372|"     This study provides an evaluation of 30 patients in 3 years, from the Unified Health System     (SUS) irrespective of region of the country, signed with clinical Parkinson's disease in its     intermediate stage and that the drug therapy is limited by side effects or beneficial effects     provided by prior medication no longer be obtained even at high doses and have therefore the     indication for treatment with deep brain stimulation.   "
48763|NCT02647359|"     This is a Phase 2, randomized, double-masked, placebo-controlled study of ataluren in     patients with aniridia caused by a nonsense mutation. Patients will receive masked study drug     for 48 weeks followed by open-label ataluren for another 48 weeks. Safety and efficacy will     be assessed.   "
48764|NCT02647346|"     The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals     associated with diabetic foot ulcers in high-risk patients.   "
48765|NCT02647333|"     In order to reduce cardiovascular risk, current European guidelines recommend a diet low on     saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA).     Polyunsaturated fatty acids can be classified into omega-3 and omega-6. However the results     from recent meta-analyses investigating coronary risk outcomes did not clearly support a low     intake of saturated fatty acids and a high intake of omega-3 or omega-6. The aim of this     study is to investigate the short term effects of a high intake of PUFAs on microvascular     function, lipids, inflammation and other cardiovascular risk factors in inactive patients     with increased waistline.   "
48766|NCT02647320|"     The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control     relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in     patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.   "
48767|NCT02647307|"     The proposed study is not hypothesis testing but is intended to explore the effects of     different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK     (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b.      Subjects entering the study will receive a single 12 hour infusion of DS-1040b and be     followed up to assess the effects on ethnicity on blood levels of DS-1040b as well as safety     & tolerability.   "
48768|NCT02647294|"     Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be     randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At     the beginning and at the end of the study basic clinical and anthropometric data, as well as     parameters of liver steatosis and fibrosis will be tested.   "
48769|NCT02647281|"     This study is a Phase 1, randomized, double-blind (Sponsor unblinded), placebo controlled,     dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) profile     of GSK3389404 as single (Part 1) and multiple subcutaneous (SC) injections (Part 2) in     healthy subjects. This study represents the first administration of GSK3389404 in humans to     define the safety, tolerability and PK following single and multiple doses of GSK3389404 in     healthy subjects.   "
48783|NCT02647099|"     ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled,     biomarker-based study of adjuvant treatment with low dose aspirin in patients with colorectal     cancer. Hypothesis is that patients diagnosed with colorectal cancer and somatic mutations in     PI3K pathway can significantly improve survival if treated with low dose aspirin.   "
48770|NCT02647268|"     Postpartum hemorrhage (PPH) is the loss of more than 500ml of blood within 24 hours after     delivery. It is a major cause of maternal morbidity and mortality across the globe.      Oxytocin is a naturally-occurring hormone that causes the uterus to contract, thereby causing     labor. A synthetic form of oxytocin is used in obstetric medicine in the same way. It causes     the uterus to contract by acting at the oxytocin receptor (OTR). It is used for both the     prevention and the treatment of PPH. By causing the uterus to contract, it constricts the     blood vessels within it, thus reducing bleeding.      Oxytocin is also used to augment labor in women with slow labor progression. Desensitization     of the OTR after prolonged exposure to oxytocin occurs, leading to reduced contractions of     the uterus with the same doses of oxytocin. This has been demonstrated in previous studies     done by the investigators. The resultant need for a higher oxytocin dose to cause adequate     uterine contraction has also been demonstrated in laboring women having received oxytocin for     labor augmentation.      Magnesium sulphate (MgSO4) is widely used within obstetric medicine. It is used for seizure     prevention and treatment in preeclampsia and eclampsia, and is used for fetal neuroprotection     in preterm labor, to reduce the risk of cerebral palsy. It is well-known to have a relaxant     effect on uterine muscle, and as such, has been used as a tocolytic agent in preterm labour     to prevent premature contractions and premature delivery. The effect of MgSO4 on contractions     in oxytocin pre-treated myometrium has not been fully elucidated with human lab studies.     There are suggestions it may lead to increased oxytocin requirements or increased postpartum     hemorrhage (PPH) in preeclamptic patients. This bears significance in the preeclamptic and     eclamptic populations who are likely to be receiving MgSO4 in combination with oxytocin.      The investigators hypothesize that MgSO4 will reduce uterine contractions in oxytocin     pre-treated myometrium, as well as untreated myometrium, and higher oxytocin doses will be     needed to produce equivalent contractions. This will help us to better understand the     implications of the use of these drugs together in the clinical setting.   "
48771|NCT02647255|"     Crescentic IgA nephropathy (CreIgAN) has a poor prognosis despite aggressive     immunosuppressive therapy. The efficacy of plasma exchange (PE) in CreIgAN is not well     defined. This study will evaluate the efficacy and safety of plasma exchange as adjunctive     therapy for severe crescentic IgA nephropathy compared to pulse methylprednisolone on a     background of oral prednisolone and cyclophosphamide in prevent kidney failure.   "
48772|NCT02647242|"     Physical activity has demonstrated its beneficial effect on functional capabilities and     quality of life in patients with PD. However, the daily physical activity remains limited in     these patients. Rhythmic auditory cueing improves spatio-temporal gait parameters in patients     with PD. The first results of BeatHealth studies have allowed us to identify the best musical     stimulation to improve these parameters and the motivation of the patients.      The originality of this study is to propose a gait auto-rehabilitation program using     BeatHealth device with optimal auditory cueing during four weeks in ecological conditions in     PD.      Observance (utilization's time), safety (falls, pain, fatigability) and efficacy (gait     parameters, balance, quality of life) will be evaluated.   "
48773|NCT02647229|"     The purpose of this physician blinded, randomized study is to determine the utility,     effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral     colonic purgative solutions for colonoscopy preparation. Patients will be randomized to     receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus     Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic     irrigation and cleansing before endoscopic procedures.   "
48774|NCT02647216|"     The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive     Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast     cancer patients in recovery. Investigators will examine whether MBCT-related improvements in     sleep quality, illness-related distress, and rumination (escalating cycles of negative     thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2).     Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity),     individual differences (e.g., perceived stress, social support), clinical characteristics     (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours     of weekly practice) help determine for whom MBCT is most effective (Aim 3).   "
48775|NCT02647203|"     This study aims to test the effectiveness in reducing or arresting root caries lesion in     community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded     RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will     be delivered to the participants in a blind format and they will be instructed to brush twice     per day.      Follow-up will be carries out every 6 months for two years to assess:        -  Root caries incidence.        -  Lesion arresting        -  Changes in salivary flow        -  Microbiology pattern shift        -  Variations in oral health- related quality of life by OHIP-14 Sp   "
48776|NCT02647190|"     The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when     used alone and together with chemotherapy and find out what effects, if any, it has on     people.   "
48777|NCT02647177|"     The purpose To determine the diagnostic potential of various biological markers in blood and     cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs).      Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository     study enrolling all patients diagnosed with pancreatic cyst and undergoing the cyst     aspiration.      Procedures to be used Blood Sample Cyst Fluid Sample      Data Collection:      Medical Record Number Demographics (age, sex, gender, race) Contact information History of     alcohol use and IV and other recreational drugs and narcotics use/abuse Medication history     Past hospitalizations, diagnoses, and treatment Physical examination findings Imaging data of     abdominal and chest regions, including and not limited to ultrasonography, magnetic resonance     imaging (MRI), computed tomography (CT) Future admissions, diagnoses, treatment including     histopathological findings of resected specimens and blood reports End of study data:     clinical progression of disease, cyst size, wall thickening, calcification, communication     with pancreatic duct, string sign, cytology, immunohistochemical findings, assay levels of     lipase, amylase CEA (carcinoembryonic antigen), carbohydrate antigen19-9 (CA 19-9), and other     biomarkers.      Risks and potential benefits The risks associated with this study are slight discomfort or     bruising from the blood sampling and the possible loss of confidentiality if the patient data     or information is inadvertently disclosed outside of this study. The patient will not receive     any additional benefit from the study aside from those received as part of routine standard     of care.      Importance of knowledge that may reasonably be expected to result The knowledge gained from     this study may benefit other patients with Pancreatic Cyst Lesions in the future.   "
48778|NCT02647164|"     The purpose of this study is to assess the value of circulating tumor cells (CTC)for     non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs,     CT and tumor markers at different time points.The time of CTC and carcinoembryonic     antigen(CEA) detection is baseline, 2~7 days, 3 months, 6 months, 12 months, 24 months, 36     months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36     months after the surgery.   "
48784|NCT02647086|"     This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab     on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with     moderate to severe AD.      The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7), study     period 2 (day 8 to 50), and a follow-up period (day 51 to 135 [end of study]).      Following completion of study period 2 (Day 50), patients will be given the option to enroll     into the Open-Label Extension (OLE) study R668-AD-1225. Patients who decline will be followed     for the next 12 weeks (Day 135).   "
48785|NCT02647073|"     Opioid dependence and its associated harms are becoming increasingly prevalent in North     America, with overdose now being the second leading cause of accidental death in the US. This     pilot study will investigate the feasibility of a novel mobile device to monitor vital signs     in both opioid-injecting individuals and hospital inpatients who are on high-dose oral     opioids. A secondary goal is to explore associations between consumption and changes in vital     signs post-injection with the long-term goal of developing a mobile system that will alert     clinicians when patients are at risk of overdose so that appropriate interventions can be     delivered in time.   "
48786|NCT02647060|"     Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to the     development of drugs, the prognosis of the disease has improved. However patients still have     poor exercise capacity and decrease of the quality of life. Past studies have shown that     idiopathic and secondary PH are different in etiology and prognosis. It is necessary to     further understand the difference between exercise capacity and quality of life of these two     types of patients.   "
48787|NCT02647047|"     The purpose of this study is to evaluate the efficacy of spinal analgesia for minor     laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale     (VAS). The investigators expect at least the same post-operative pain control in the two     groups (non inferiority of pain control with spinal analgesia compared to epidural     analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease     in patient's length of hospitalization according to enhanced recovery after surgery (ERAS)     principles.   "
48788|NCT02647034|"     This study investigated clinical parameters, laboratory data, imaging studies to evaluate     patients with suspected pulmonary hypertension.   "
48789|NCT02647021|"     The investigators will conduct a randomized controlled trial examining 12-week, 24-week and     one year outcomes from a combined therapeutic and physical exercise program that aims to     bridge head-and-neck cancer survivors from acute care rehabilitation services to     community-based exercise programming.   "
48790|NCT02647008|"     Aim: To compare the pain-relieving effect of a specific application of TENS vs. placebo TENS     and a control group during unsedated diagnostic office hysteroscopy.      Design: double-blind randomized placebo-controlled trial. Setting: Outpatient setting.     Population: Women who attended annual gynecological check up, and were indicated for     diagnostic office hysteroscopy.   "
48791|NCT02646995|"     The purpose of this trial is to evaluate if the use of a newly developed lipid formulation     versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of     supplementation.   "
48792|NCT02646982|"     This study is intended to investigate the effect of candesartan, a blood pressure medication,     on cognitive function and thinking skills in those who have early or mild memory     difficulties, also called mild cognitive impairment or MCI.   "
48793|NCT02646969|"     Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein     concentrations over the first year of life   "
48794|NCT02646956|"     The goal of the study is to determine whether there are age-, diet- and genetically-related     differences in the perception of sweeteners, both nutritive and non-nutritive.   "
48795|NCT02646943|"     BACKGROUND: Chagas Disease (ChD) remains as one of the most neglected diseases in the world,     with 8-10 million infected people and only one marginally effective therapeutic. The lack of     good biomarkers for active infection or clinical end-points poses a problem for assessing the     performance of new drugs or therapeutic interventions. Among the biomarkers, several studies     showed that Brain Natriuretic Peptide (NT-ProBNP) is accurate maker of left ventricular     systolic and diastolic dysfunction.      OBJECTIVE: Our long term goal is to establish The Sao Paulo-Minas Gerais Tropical Medicine     Research Center (SaMi-Trop) as a Center of Excellence for Neglected Infectious Disease     Research in Brazil. The Specific Aims are to begin that process by focusing on Trypanosoma     cruzi infection with the goal of finding an array of biomarkers that correlate with parasite     persistence and Chagas cardiac disease status that can be used to infer risk of disease     progression and death as well used as markers of cure (parasite eradication) or clinical     efficacy (stabilize or reverse cardiac damage) of novel drugs      METHOD: The investigators established a prospective cohort of 1,959 patients with chronic     Chagas cardiomyopathy (CCC). The study is being conducted in 21 cities of the northern part     of Minas Gerais state in Brazil, and includes a follow up of at least two years (baseline and     24 months) . The evaluation included collection of socio-demographic information, social     determinants of health, health-related behaviours, comorbidities, medicines in use, history     of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life,     blood sample collection and ECG.   "
48810|NCT02646748|"     This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or     metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part     2). Two treatment groups (Group A and Group B) will be evaluated      Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced     solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib     (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a     PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum     tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each     combination.      Once the recommended dose has been identified in Part 1a, subjects with select solid tumor     types will be enrolled into safety expansion cohorts based upon prior treatment history with     a PD-1 pathway-targeted agent (Part 1b) for each combination.      Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with     pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate     the combination in patients with non-small cell lung cancer (NSCLC).   "
48796|NCT02646930|"     Background: Embryo quality is known to be a very important determinant to predict the     implantation and pregnancy rate in IVF patients, however, the role of uterine integrity or     endometrial receptivity cannot be overlooked.      Chronic endometritis (CE) is an inflammation of the endometrium diagnosed by the presence of     plasma cells in the endometrial stroma. There is not only no census on the definition of CE,     the current literature on the impact of CE on reproductive outcome is controversial and     consists only of retrospective studies with small sample sizes. Although there is a     presumption that CE is related to poor IVF outcome, this belief has not been proven.      Design: Prospective cohort study      Setting: Infertility clinics of 2 academic medical centers      Patients: Patients between the ages of ≥ 21 and ≤ 35 years old undergoing their first IVF     cycle will be invited to participate.      Main Outcome Measures: The primary outcome will be ongoing pregnancy after 12 weeks estimated     gestational age (EGA) with previously documented fetal cardiac motion. Secondary outcomes     will include pregnancy loss rate as defined by chemical pregnancy, blighted ovum or loss of     fetal cardiac motion before 12 weeks EGA.      Materials and Methods: The cycle prior to IVF, patients will undergo an in-office endometrial     biopsy on cycle days 19-24. Samples will be stained for CD138 and the number of plasma cells     will be quantified. The number of plasma cells in a sample that yields the best sensitivity     and specificity for pregnancy will be determined by a Receiver-Operator-Curve. This number     will then be used as a dichotomous variable to assign categories of positive for CE and     negative for CE. Pregnancy and miscarriage rates will then be determined in the positive     and negative CE sample with Chi Square Analysis. A secondary sub analysis will be performed     to determine pregnancy and miscarriage rates in patients who declined to participate in the     study.      Expected Results: The investigators hypothesize that higher rates of CE will be found in     women failing to conceive with IVF and with subsequent first-trimester miscarriage.   "
48797|NCT02646917|"     This single-center, clinical trial will take place over a 90 day course followed by 1-month     and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen     device when used on both men and women on the face and/or back.   "
48798|NCT02646904|"     The purpose of this study is to examine in children with persistent AR the effect of the     topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by     acoustic rhinometry and subjective nasal symptoms.   "
48799|NCT02646891|"     This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus     vaccine). The study will examine the safety and immunogenicity of three dose levels of this     vaccine in healthy South African adults, toddlers and infants. Progression from one dose     level to another and to the next age group population will be based on the assessment of     safety information from the lowest dose and older age group.      The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and     well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit     rotavirus vaccine is immunogenic in infant participants and will induce an immune response to     at least 2 of the 3 strains in 60% or more of participants in at least one of the study     groups.   "
48800|NCT02646878|"     The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in     subjects age 14 - 75 years.   "
48801|NCT02646865|"     This study evaluates the addition of a self-compassion training in the treatment of social     anxiety disorder. Half of the participants will receive a self-compassion enhanced group     cognitive-behavioral therapy, while the other half will receive standard group     cognitive-behavioral therapy.   "
48802|NCT02646852|"     This is a Phase I, two-stage, open-label, single-arm, dose escalation study of DFP-13318     intravenous infusion administered to patients with refractory or relapsed solid tumors. This     study will explore two different dosing schedules- once every 3 weeks (q3w) and once every 2     weeks (q2w) - during Stage 1 and Stage 2, respectively.   "
48803|NCT02646839|"     This is a phase II, open-label, non-randomized, prospective study of haploidentical     transplantation using KIR-favorable donors for children with acute lymphoblastic leukemia     (ALL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic     hematopoietic cell transplantation (HCT). The relationship of KIR2DL1 polymorphisms to     survival in children with these diseases undergoing any approach to allogeneic HCT during the     study time frame will also be determined.   "
48804|NCT02646826|"     This is a multi-center, double-blind, placebo-controlled study with two weeks of daily oral     administration of one of three dose levels of Paxerol or placebo in subjects with nocturia.     Eligible study subjects will be identified according to inclusion/exclusion criteria (see     below), and baseline assessments will be recorded.      Due to small sample size of 25 patients per group in this proof-of-principle dosing-finding     trial, stratification according to gender and BMI will be difficult. However, similar     distribution of patient types to the four treatment groups will be attempted by evenly     assigning patients to the four treatment groups according to genders and body mass index     (BMI) of <25, 25-30 and 30-40.      Paxerol or placebo will be taken 30 minutes before bedtime daily for two weeks. Nocturia     frequency, Nocturia Quality of Life (NQOL), Duration of First Undisturbed Sleep (DFUS), total     hours of nightly sleep, safety and tolerability will be monitored before and after a two-week     treatment period. Results from subjects treated with different doses of Paxerol and placebo     will be assessed and compared. Baseline urinary Prostaglandin E2 (PGE2) production will also     be assayed to assess potential correlation between baseline urinary PGE2 production and     responsiveness to Paxerol treatment.   "
48805|NCT02646813|"     The objective of this study is to evaluate the time and ease of placement of an extra-luminal     Arndt bronchial blocker versus placing it intra-luminally.      An additional objective will be to assess if there are any other significant clinical     differences between these two approaches to placement of the BB including overall quality of     isolation, an increase in post-operatives sore throat, post-operative hoarseness, and     increased incidence of needing to reposition the blocker   "
48806|NCT02646800|"     The objective of this study is to evaluate the safety and efficacy of intravenous micafungin     for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.   "
48808|NCT02646774|"     The objective of this study is to evaluate the efficacy and safety of intravenous micafungin     for the treatment of proven or probable fungal infections caused by Aspergillus sp.     (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.   "
48809|NCT02646761|"     The purpose of this study is to determine if home-based therapy with monitoring via     telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients     undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient     physical therapy course. Subjects will undergo standard physical therapy or physical therapy     paired with InterACTION for 10 weeks.   "
48870|NCT02645968|"     The purpose of this study is to collect valid data from all forms of health care on the     incidence, prevalence, the regional distribution, characteristics, management and outcomes of     different ILDs under clinical practice conditions.   "
48813|NCT02646709|"     Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40     minute after single bolus injection. For outpatient surgery with short operation time, low     dose rocuronium is frequently used for rapid recovery at the expense of compromised     intubating condition. For better intubating condition, ketamine can be used. However,     appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3     different doses of ketamine with low dose rocuronium will be compared for appropriate     intubating condition.   "
48814|NCT02646696|"     The purpose of this study is tTho establish test-retest reliability of electrodermal markers     used to quantify physiologic response to sensation using the Sensory Challenge Protocol in     children with and without Autism Spectrum Disorder (ASD).   "
48815|NCT02646683|"     This multi-centre open label study will involve a minimum of 260 patients in 2 cohorts: 130     patients with 'early CD' defined as disease duration < 24 months and no other treatments than     corticosteroids and 130 patients with 'late CD' defined as active disease despite treatment     with immunosuppressives and anti-TNF. Patients with intolerance to IS and anti-TNF will also     be allowed in the latter group. Participants will be treated with 12 months of open label     vedolizumab (study medication followed by commercial medication once reimbursement is     available) and undergo monitoring of endoscopic, histological and clinical disease     parameters. No randomization or blinding will be performed but the study management will     ensure that recruitment in either study group is comparable for number and profile of     patients (on/off steroids).   "
48816|NCT02646670|"     The purpose of this study in to compare the efficacy of treatment of diabetic macular edema     (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus     Ranibizumab (Lucentis®).      It is a randomized clinical trial that will evaluate the efficacy of the combination of two     substances currently used in the treatment of DME. Will be allocated in different four groups     randomly pacients who receive treatment with intravitreal injections of ranibizumab,     aflibercept or a combination of aflibercept and ranibizumab.   "
48817|NCT02646657|"     This multi-centre open label study will involve a minimum of 120 patients in 2 cohorts: 60     patients with 'early UC' defined as disease duration < 4 years and no other treatments than     aminosalicylates and/or corticosteroids and 60 patients with 'late UC' defined as active     disease despite treatment with immunosuppressives (IS) and/or anti-TNF. Patients wih     intolerance to IS AND anti-TNF will also be allowed in the latter group. Participants will be     treated with 12 months of open label vedolizumab and undergo monitoring of endoscopic,     histological and clinical disease parameters. No randomization or blinding will be performed     but the study management will make sure recruitment in either study group is comparable for     number and profile of patients (extent of disease and on/off corticosteroids).   "
48818|NCT02646644|"     In an individual cancer patient extensive genetic and phenotypic variation exists between and     within tumor lesions. Tumour load in NET patients can be measured with     fluorine-18-L-dihydroxyphenylalaninepositron emission tomography (18F-DOPA-PET) scan.      This aim of the study is to investigate heterogeneity between tumor lesions within patients     with intestinal NET by determining the differences in tracer uptake measured on a 18F-     DOPA-PET scan retrospectively.   "
48819|NCT02646631|"     The long-term goal of this research is to improve seizure control among patients with     epilepsy, which has the potential to improve quality of life for thousands of people living     with epilepsy and reduce health care utilization, social and economic costs, and     epilepsy-related mortalities. Participants who are suffering from epilepsy will be randomized     to receive usual care (UC), a smartphone-based self-management intervention called Management     of Risks in Epilepsy (MORE), or MORE + telephone-based motivational interviewing (MI).     Participants will be followed for 3 months.   "
48820|NCT02646618|"     The present study is a non-inferiority trial comparing the efficacy of a lifestyle     intervention delivered entirely via an online social network to a traditional lifestyle     intervention delivered via group meetings.   "
48821|NCT02646605|"     Quantitative, validated tools of depression screening will be used to collect data to     determine the prevalence of depression and its association with antiretroviral (ARV)     adherence amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi.   "
48822|NCT02646592|"     This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in     children under general anesthesia, before skin incision.   "
48823|NCT02646579|"     The purpose of this study is to determine if dry needling both low back and extremity areas     is more effective for reducing pain and improving strength, balance and functional     performance among patients with chronic musculoskeletal conditions compared to dry needling     of extremity areas only.   "
48824|NCT02646566|"     Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless,     dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established     PONV, in patients who have had prior PONV prophylaxis.   "
48825|NCT02646553|"     Cortisol overproduction ( Cushings syndrome) is a condition where the patient have a special     fat distribution, with accumulation of fat around the abdomen and in the neck, with thinner     limbs and weak musculature. The condition can be difficult to separate from adipositas in     general. Screening for hypercortisolism in adults has been easier the last years, because we     can measure free cortisol in saliva samples at late night. In children we still dont have     reference ranges for saliva cortisol in children, so the screening is still troublesome,     based on Collection of 24-hour urine.The meaning of this study is to establish reference     ranges for saliva cortisol, and evaluate in a cohort with adipose children if screening with     saliva cortisol is sensitive and specific enough to be the New screening test for     hypercortisolism in children too.   "
48826|NCT02646540|"     The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given     in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It     will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to     IV diuretics. The investigators are looking to see if there is improvement in the symptoms     and outcomes of persons with acute heart failure.   "
48871|NCT02645955|"     Primary Purpose:        1. Evaluate the prevalence and incidence of HEV infection in MHD patients.        2. Compare differences of the prevalence and incidence between the MHD patients and the          control. .      Secondary purpose:      Analyze risk factors of HEV infection.   "
48827|NCT02646527|"     Background: There has been significant progress in symptom management, pain relief and     improvement of quality of life in patients nearing death by implementing palliative care     programs. Existential and dignity related issues, such as loss of autonomy and sense of     meaning or feeling a burden to others are frequent reasons for psychological distress and     desire for hastened death. Dignity Therapy (DT), developed by Chochinov et al., is a brief,     individualized psychotherapy for the purpose of relieving distress by directly addressing     dignity conserving factors.      Aims: To test whether the inclusion of a patient's partner or designated family member into     Dignity Therapy (DT+) could mitigate psychological distress (anxiety and depression) in both,     the patient nearing the end of his life experiencing increased psychological distress and the     patient's partner/family member compared to the control groups receiving Dignity Therapy in     the single setting (DT) or standard palliative care (SPC).      Methods and design: In this randomized controlled trial a total of 159 patients with a     diagnosis of an advanced disease and poor prognosis (life expectancy < 6 months) who receive     palliative care either in the Palliative Care Centre of the University Hospital Zurich (USZ)     or the Clinic Susenberg, Zurich, or in the Lighthouse Hospice Zurich, will be randomly     assigned to either DT+, DT, or SPC in a 1:1:1 ratio. Patients will be pre-screened and     included if they report increased psychological distress (anxiety, depression using the     Hospital Anxiety and Depression Scale=HADS). The therapy is guided by trained therapists and     consists of 3 audiotaped sessions. The main focus of the intervention is to invite patients     to reflect on their most important achievements, roles or other things in their lives or     things that they would most want remembered. On completion, the audiorecording is transcribed     and edited to provide a clear and readable narrative, the generativity document, which can be     passed to a person of the patient's choice. DT+, in contrast to the original intervention     developed by Chochinov et al., is a systemic approach in which patient's partners or     designated family members are included.   "
48828|NCT02646514|"     Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma,     gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary     drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of     choice in these patients. When compared to plastic stents, SEMS present a significantly     decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than     plastic stents in patients with a life expectancy of longer than 4 months. However, despite     their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8     months.      Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the     early 1990s. Other studies have investigated its role in diseases of the colon and esophagus.     More recently, this technique has been recognized for its potential in palliative treatment     of malignant biliary strictures. RFA uses a high-frequency alternating current to generate     heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA     appears to be safe and may result in decreased benign epithelial hyperplasia and tumor     ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other     hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea,     recently.      The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by     using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in     patients with malignant biliary strictures.   "
48829|NCT02646501|"     The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in     patients with recurrent sustained VT/VF in spite of appropriate medical therapy and     cardio-version/ defibrillation after correction of underlying correctable factors with those     without PSGB by prospective randomized trail. PSGB will be performed every 3 days by     anesthesiology specialist after cardiologist's request, until the stabilization of VT/VF. We     will compare the frequency and episode number of VT/VF, procedure related complication, acute     and long-term mortality.   "
48830|NCT02646488|"     The primary purpose of this study is to evaluate the effectiveness of practice facilitation     as a quality improvement strategy for implementing the Million Hearts' ABCS treatment     guidelines for reducing cardiovascular disease (CVD) among high-risk patients who receive     care in primary care practices in New York City. The ABCS refer to the following: Aspirin in     high-risk individuals (A), Blood pressure control and management (B), Cholesterol management     (C), and Smoking cessation (S). The long-term goal is to create a robust infrastructure to     disseminate and implement evidence based practice guidelines (EBPG) findings in primary care     practices and improve practices' capacity to receive and implement other EBPG findings in the     future.   "
48831|NCT02646475|"     The overall purpose of this study is to learn more about the metabolic effects of     angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic     approaches to increase angiotensin-(1-7) levels or its actions are currently in development     for treatment of metabolic-related diseases such as obesity and type II diabetes, based on     findings from animal studies. It is unclear if this peptide contributes to the regulation of     metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve     insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with     obesity and insulin resistance. The investigators will also examine for changes in blood     pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion.   "
48832|NCT02646462|"     Prospective investigation of the ratio between malignant and total number of lymph nodes in     predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national     Danish project.   "
48833|NCT02646449|"     Recent reports have shown that alcohol misuse is a particularly serious problem among the 18     to 25 year old age group. Previous medication trials with SSRI antidepressants among young     adults with co-occurring depressive disorders, including our own recent trials with SSRI     medications, have produced disappointing results, especially for decreasing the level of     alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and     mechanism of action. Recent study results suggest that mirtazapine is more effective than     other antidepressants for treating non-comorbid depression. A few recent studies with     mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have     demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol     craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of     alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use     of that comorbid population. The results of our own very recent open label pilot study     suggest robust within-group efficacy for mirtazapine for decreasing both the level of alcohol     use and the depressive symptoms of comorbid subjects. However, that pilot study did not     include a placebo control group, so the efficacy of mirtazapine versus placebo for decreasing     the level of alcohol use among persons with comorbid AUD/MDD remains unclear. This grant     submission proposes to conduct a first double-blind, placebo-controlled pilot study to     provide a preliminary assessment of the efficacy of mirtazapine versus placebo for decreasing     both the alcohol use and depressive symptoms of young adults with comorbid AUD/MDD. If     results (effect sizes) from the proposed study are found to be promising concerning outcome     differences between the mirtazapine and placebo groups, then we will use those findings to     apply for an R01 study to definitively assess the efficacy of mirtazapine for treating young     adults with AUD/MDD.   "
48855|NCT02646163|"     REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry activity against hepatitis C     virus and entry and post-entry antiviral activity against duck hepatitis B virus (DHBV)     infection. REP 2055 has been shown to have potent prophylactic effect against HCV infection     in vivo and potent therapeutic effect against established DHBV infection in vivo      The REP 101 protocol is the first-in-man proof of concept study designed to investigate the     safety and antiviral activity of REP 2055 administration in human patients with chronic HBV     or HCV infection.   "
48834|NCT02646436|"     Peritoneal dialysis (PD) has become a well-established complementary alternative to     haemodialysis (HD) as first-line renal replacement modality. At department of Botucatu     Medical School, more than 60% of the chronic kidney disease (CKD) stage 5 patients are     started urgently on chronic dialysis due to late referral or unexpected deterioration of     residual renal function. These patients, although suitable for PD, were previously started on     HD using central venous catheter. Since July 2014 patients have been offered urgent start on     chronic PD right after PD-catheter insertion by percutaneous surgery, using Seldinger     technique. The main objective is to compare technique and patients survival on unplanned PD     vs. unplanned HD in the first 180 days. Methodology: Quasi experimental study which will     describe how acute PD will initiated using high volume PD until metabolic and fluid control     right after (<48 h) PD catheter placement standard prescription for a 12 h overnight     automatic PD until hospital discharge and intermittent PD at dialysis unit family training.   "
48835|NCT02646423|"     Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly     one third of births annually. In the last decade, the CD rate has increased by approximately     50%, with almost 1.3 million procedures performed in 2012 (Hamilton 2013). CDs have been     associated with an increase in major maternal morbidity (Silver 2010), with corresponding     increases in length of inpatient care following delivery and frequency of hospital     readmission (Lydon-Rochelle 2000). Organizations including Healthy People, the American     College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives     have targeted reducing the CD rate as an important public health goal for more than a decade;     however, identifying interventions to achieve this goal has proven challenging.      Repeat CDs are a significant contributor to the increased cesarean rate, resulting from the     combination of a rising rate of primary CD and a decreasing rate of vaginal birth after     cesarean (VBAC), which declined from a high of 28.3% in 1996 (Guide 2010) to 9.2% in 2010     (Hamilton 2011). Why the VBAC rate has decreased so dramatically remains a subject of debate;     the extent to which these changes are driven by patient preferences is not known. An NIH     consensus conference statement noted that the informed consent process for TOLAC and     Elective Repeat Cesarean Delivery (ERCD) should be evidence-based, minimize bias, and     incorporate a strong emphasis on the values and preferences of pregnant women, and     recommended interprofessional collaboration to refine, validate, and implement     decision-making and risk assessment tools to accomplish that goal (Cunningham 2010).      Our group recently created a decision tool, which we refer to as the Prior CD App (PCDA), to     help English- or Spanish-speaking TOLAC-eligible women delivering at hospitals that offer     TOLAC consider individualized risk assessments, incorporate their values and preferences, and     participate in a shared decision making process with their providers to make informed     decisions about delivery approach. We are now conducting a randomized study of the effect of     a Prior CD App on TOLAC and VBAC rates, as well as a number of aspects of decision quality.   "
48836|NCT02646410|"     Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy     for malaria control in countries with seasonal malaria transmission such as Mali in March     2012. The goals are to identify the most effective method to deliver SMC, and to obtain more     information on the long term impact of SMC on malaria immunity. Our specific aims are 1) to     determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly     observed treatment (DOT) vs non-DOT (NDOT)) and frequency (3 vs 4 doses per season) of SMC     delivery; 2) to compare quantitative measures of immunity in children who do and do not     receive SMC. A cluster-randomized design will be sued. The target population will be children     aged 3-59 months old in Ouelessebougou district, Mali. In Year 1, villages in four     sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The     optimal mode of delivery will be selected based on the SMC coverage during the first year,     and will then be implemented in villages of two additional sub-districts. Villages in these     two newly selected sub-districts will be randomized in two groups. Children in the first     group will received three rounds of SMC and those in the second group will receive four     rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of     clinical malaria as measured by passive surveillance. In Year 3, children in the selected     sub-districts will received SMC by the optimal delivery system determined in Years 1 -2.   "
48837|NCT02646397|"     The purpose of this study is to compare the effect of fosinopril plus benidipine vs.     fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD     patients with HTN.   "
48838|NCT02646384|"     The Institutional Review Board (IRB) protocol is being designed to offer ovarian tissue     cryopreservation to female pediatric patients (birth-17 years of age) with fertility     threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may     cause loss of reproductive potential. Because this procedure is currently considered     experimental, the establishment of an IRB protocol under which this opportunity can be     offered is needed.   "
48839|NCT02646371|"     In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be     tested for its ability to induce an immune response that protects healthy adult volunteers     from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving     placebo.   "
48840|NCT02646358|"     This is an open-label study designed to evaluate the effect of renal disease on the     pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with     normal renal function.   "
48841|NCT02646345|"     Limited information is available about surgical checklist effectiveness in Latin America. We     plan to compare the pre and post surgical checklist implementation in a tertiary healthcare     center in terms of morbidity (length of stay and surgical site infection rate) and     in-hospital mortality rate.   "
48842|NCT02646332|"     Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains     unanswered.   "
48843|NCT02646319|"     This pilot phase II trial studies how well nanoparticle albumin-bound rapamycin works in     treating patients with cancer that as has spread to other places in the body and usually     cannot be cured or controlled with treatment (advanced cancer) and that has an abnormality in     a protein called mechanistic target of rapamycin (mTOR). Patients with this mutation are     identified by genetic testing. Patients then receive nanoparticle albumin-bound rapamycin,     which may stop the growth of cancer cells by blocking the mTOR enzyme, which is needed for     cell growth and multiplication. Using treatments that target a patient's specific mutation     may be a more effective treatment than the standard of care treatment.   "
48844|NCT02646306|"     The aim of the study focused on the creation of a rehabilitative measuring device     (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination     methodology for assessing the proprioception of the glenohumeral joint respect to scapula     abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects     and in patients with shoulder impingement syndrome.   "
48845|NCT02646293|"     The incidence of the diagnosis of renal cell carcinoma has increased during the past two     decades because of the detection of small renal tumours that occur incidentally because of     increased use of CT-scanning (1,2). Postoperative renal insufficiency was a significant     independent predictor of overall and cardiovascular specific survival (3). Nephron-sparing     surgical techniques are now preferred for small tumor masses and laparoscopic intervention is     replacing open surgery at centers that master this technique. This is an area of priority     within the Regions of Zaeland and Southern Denmark.      The primary endpoint is:      The early plasma (5 days) [NT-proBNP] response predicts long-term total renal function and     function of the remaining kidney.      The second endpoint:      Plasma [NT-proBNP] increases acutely after partial nephrectomy and the change reflects the     renal mass reduction.      Chronic blood pressure change is inversely related to plasma [BNP].   "
48846|NCT02646280|"     The purpose of the study is to determine the effectiveness of an approach that combines     massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the     words of the physiotherapist compared to a traditional massage therapy in reducing pain in     patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is     linked to the interoceptive awareness and which is the patient's ability to relax through the     measurement of the hearth rate variability (HRV).   "
48847|NCT02646267|"     The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate     and different intensity warfarin for the prevention of stroke and systemic embolism in     patients with non-valvular atrial fibrillation.   "
48848|NCT02646254|"     Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair:     a randomized study of Two cardioplegic techniques.   "
48849|NCT02646241|"     To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are     required. It is difficult to obtain adequate tissue samples. There were several biopsy     methods to obtain tissue samples. Pathological examination would include mitosis counts,     particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall,     where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor     (GIST) of malignant potential is essential.      So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic     ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and     complications between EUS-FNB & unroofing biopsy.   "
48850|NCT02646228|"     With rapid advances in molecular oncology, the availability of preclinical in vitro cell     models and in vivo animal models with specific genomic aberrations is critical for improved     prediction of clinical outcomes in cancer patients. One of the most widely used preclinical     models is conventional cell lines, such as the NCI-60 panel of cell lines;these cell lines     are widely used in preclinical testing for novel targeted drugs, partially owing to the low     expense and reduced labor associated with cell culture compared with other preclinical     models, such as animal xenografts. However, recent studies have shown that accumulation of     genetic aberrations in cancer cell lines occurs with increasing passage number. These models     also lack the heterogeneity of tumors and do not exhibit a proper microenvironment,     highlighting the limitations of cell-based models. Consistent with this, Johnson et al.     demonstrated that in vivo activities of the cell lines within the NCI-60 panel did not     closely correlate with corresponding human cancers.      Therefore, to better preserve the genomic integrity and tumor heterogeneity observed in     patients, patient-derived xenograft (PDX) models are being used more frequently. PDX is     generated by directly transplanting freshly resected patient tumors into immunocompromised     murine hosts with or without an intermediate in vitro culture step. This PDX model is an     improvement over cell lines because it can provide both an appropriate tumor microenvironment     and heterogeneity of tumor cells. However, the engraftment success rates and growth rates of     implanted tumors are highly variable depending on the tumor type, possibly due to     insufficient numbers of hematopoietic cells and/or ineffective microenvironmental cues in the     mouse stroma. The extent to which tumor cells from freshly resected tumors are able to     withstand mechanical stresses and xenotransplantation barriers is also unclear. Furthermore,     the use of PDX models for application in clinical oncology is limited owing to the time     required for PDX establishment (> 4 months) since most patients with refractory cancer live     less than 1 year. Recently, PDC line models have been suggested as an alternative preclinical     model to be used as a prediction tool for preclinical drug sensitivity.      Therefore, in this study, the investigators aimed to overcome these potential barriers of     pre-existing models by examining the capacity of PDC line models to recapitulate the     histological and genomic features of primary patient tumors. In selected cases, the     investigators screened drug sensitivity in vitro using PDC lines and compared the results     with real-life clinical treatment outcomes.   "
48851|NCT02646215|"     Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients   "
48852|NCT02646202|"     Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro     esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation     are very effective in controlling acute esophageal varices bleeding and preventing     rebleeding.   "
48853|NCT02646189|"     REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral     activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have     potent therapeutic effect against established DHBV infection in vivo      REP 2055 was additionally shown to have significant antiviral effects in patients with     chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055     designed for improved administration tolerability and stability.      The safety and antiviral activity REP 2139, first in monotherapy and then in combination with     immunotherapy in patients with chronic HBV infection will be assessed in the REP 102     protocol.   "
48854|NCT02646176|"     Traumatic brain injury (TBI) is increasingly recognized as a significant public health issue,     but the most effective rehabilitation methods have yet to be identified. The Institute of     Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of     evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews     concluded that substantially more research is needed to identify interventions best suited     for different individuals. The practice-based evidence (PBE) approach employed to create the     data used in the proposed study was a research method recommended to provide greater clarity,     along with use of patient-centered outcomes obtained over a longer period of time than used     in previous studies.      The following specific aims will be addressed in the proposed study:        1. Determine the comparative effectiveness of different therapeutic approaches used in          inpatient TBI rehabilitation after statistically adjusting for patient need and ability          to benefit from various approaches.           Investigators hypothesize:           1.1. Patients who receive a greater proportion of therapy time in Advanced Training          (versus Standard of Care) will achieve better outcomes than similar patients who receive          a lesser proportion of treatment time in Advanced Training.           1.2. Patients with the greatest initial levels of disability will experience larger          effects from Advanced Training therapeutic approaches in comparison to the effects          experienced by patients with less disability at admission.           1.3. Patients who receive a greater proportion of therapy in contextualized treatment          (versus decontextualized) will achieve better outcomes than similar patients who receive          a lesser proportion of time in contextualized treatment.        2. Determine the comparative effectiveness of difference in the delivery of inpatient          rehabilitation therapies, after statistically adjusting for patient need and ability to          benefit.      Investigators hypothesize:      2.1 The level of effort that patients are able to apply in treatment moderates the     effectiveness of time in treatment.      2.2 Family involvement in treatment is associated with better outcomes.      Data will be drawn from the database established for the TBI Practice-Based Evidence Study     (TBI-PBE Study). Data on 2130 persons who received inpatient TBI rehabilitation at any of 10     sites (9 in US, 1 in Canada) were obtained for the study. Detailed longitudinal data were     collected prospectively on rehabilitation therapies (with point of care data completed for     every clinical encounter), course of recovery, person and injury characteristics and outcomes     during and after rehabilitation. Advanced analytic methods (e.g. propensity scores,     generalized linear mixed models) will be used to compare the effects of different     rehabilitation interventions on outcomes at discharge and during the 9 months following     rehabilitation.   "
48858|NCT02646124|"     Low back pain (LBP) causes 2.4% of visits to US emergency departments (ED) resulting in 2.7     million visits annually. In general, outcomes for these patients are poor. One week after ED     discharge, 70% of patients report persistent back-pain related functional impairment and 69%     report analgesic use within the previous 24 hours. Three months after the ED visit, 48% of     these patients report functional impairment, 42% report moderate or severe pain, and 46%     report persistent analgesic use.      It is not clear how acute LBP should be treated. Non-steroidal anti-inflammatory drugs     (NSAID) are guideline-supported, first line therapy for acute LBP. NSAIDs are more     efficacious than placebo with regard to pain relief, global improvement, and requirement of     analgesic medication but are not sufficient therapy for as many as ½ of ED patients, who     continue to suffer despite therapy with NSAIDs. Treatment of LBP with multiple concurrent     medications is common in the ED--emergency physicians often prescribe benzodiazepines,     skeletal muscle relaxants, or opioids in combination with NSAIDs. However, work recently     completed here at Montefiore has revealed that combining skeletal muscle relaxants or opioids     with NSAIDs does not improve outcomes. It remains uncertain if adding benzodiazepines to     NSAIDs improves LBP outcomes.      Although benzodiazepines are used in 300,000 US ED visits for LBP annually, scant evidence     exists to determine the appropriateness of this approach. Efficacy of benzodiazepines may be     related to direct or centrally-mediated action on skeletal muscle or may instead work by     mitigating anxiety about the condition or numbing a patient to the pain.      Given the poor pain and functional outcomes that persist beyond an ED visit for     musculoskeletal LBP, we propose a clinical trial to evaluate whether combining a     benzodiazepine with an NSAID is more effective than NSAID monotherapy for the treatment of     acute, non-traumatic, non-radicular low back pain. Specifically, we will evaluate the     following hypothesis:      A daily regimen of naproxen + diazepam will provide greater relief of LBP than naproxen +     placebo one week after an ED visit, as measured by the Roland Morris Disability     Questionnaire.   "
48859|NCT02646111|"     The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie     adults with chronic hepatitis C virus (HCV), who have not responded to prior treatment with     protease inhibitors.      The Triple therapy of AbbVie attacks various sites of the viral genome, thus increasing the     potential efficacy of the treatment, especially for patients who have failed PI treatment.   "
48860|NCT02646098|"     Primary objective:      To assess the differences in the overall survival at 3 years of a CD34+ cell selection versus     no selection of hematopoietic progenitor cells harvested during peripheral blood stem cell     collection before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in     advanced stage mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) patients.      Secondary objectives:      To assess differences in disease-free survival between CD34+ cell selection versus no     selection of hematopoietic progenitor cells harvested during peripheral blood stem cell     collection before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in     advanced stage mantle cell (MCL) or in diffuse large B-cell lymphoma (DLBCL) patients.      To compare hematologic engraftment and the time needed until hematologic recovery after ASCT     using CD34+ selected or unselected autologous stem cell grafts.      To compare infectious complications, particularly CMV infections, observed until 100 days     after ASCT comparing CD34+ selected or unselected autologous stem cell grafts.      To assess the response rate at day 100 after ASCT in advanced stage mantle cell lymphoma     (MCL) or diffuse large B-cell lymphoma (DLBCL) patients after ASCT comparing patients with     CD34+ cell selection versus no selection.      To assess the total time needed for the apheresis procedure and the number of apheresis days     needed to ensure the collection of a sufficient number of autologous stem cells comparing     patients with CD34+ cell selection versus no selection.      To assess the need for the additional use of G-CSF (Neupogen) and of the stem cell releasing     compound Plerixafor (Mozobil) to ensure the collection of a sufficient number of autologous     stem cells comparing patients with CD34+ cell selection versus no selection.      Outcome(s):      The aim of the study is to show ≥ 15% better 3-year overall survival of lymphoma patients     having received CD34+ cell selection during autologous stem cell collection before autologous     stem cell transplantation compared to no CD34+ cell selection.   "
48862|NCT02646072|"     The purpose of this study is to determine whether there is a relationship between     inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment     of topical ketorolac for patients undergoing cataract surgery.   "
48863|NCT02646059|"     Blood donor recruitment is an important issue in every country, since the blood supply     pressure become more and more intense. Donor retention is even more important, because it is     easier to recruit an old customers than a new one. Therefore, figuring the most effective     ways of recruiting lapsed blood donors and understanding the reasons of not donating blood     again is critical and vital for the development of blood donation.   "
48864|NCT02646046|"     Investigators designed the novel combining technique that rescuer start the chest compression     with one hand during calling for help to the Emergency Medical System (EMS) via a cell phone     with another hand when he witnessed the arrest victim. This method may be helpful to reduce     the hand-off time and increase the faction time of chest compression until the arrival of EMS     members.      To verify this hypothesis, we conducted a random, controlled simulation study.   "
48865|NCT02646033|"     This study analyse the rise in Intraocular Pressure while patient is in surgery in head low     position.   "
48866|NCT02646020|"     Study hypothesis is that aprepitant is more effective than desloratadine in relieving     pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective     treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to     baseline score. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe     pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender, first or     seconde generation TKIs, VAS 4-6 or 7-10) randomized (1:1) into aprepitant or desloratadine     treatment. VAS investigation will be taken once a week to treatment end or follow-up end (≤12     weeks).   "
48867|NCT02646007|"     Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is     usually progressive without treatment.      Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells     are the best candidates for this kind of treatment.      This study examined lunate core decompression in combination with implantation of autologous     bone marrow derived mesenchymal stromal cells for Its treatment potential.      Bone decompression in combination with implantation of autologous bone marrow derived     mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.      The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.      The Spss(v16) software will be used for data analysis.   "
48868|NCT02645994|"     Advancement in techniques for anaesthetic drug delivery and real time monitoring has     facilitated safe induction and maintenance of anaesthesia in severely compromised patients.     Cardiac diseases are the commonest causes of morbidity and left ventricular failure is the     commonest clinical presentation at the end stage. LV systolic dysfunction is defined as     reduction in LVEF ≤55%. Patients with LVEF 55%-46% have mild, 45%-36% moderate and ≤35%     severe LV systolic dysfunction. Patients with heart failure have a diminished cardiac reserve     capacity that may be further compromised by anaesthesia. In addition to depression of     sympathetic activity, most anaesthetics interfere with cardiovascular performance, either by     a direct myocardial depression or by modifying cardiovascular control mechanisms. Propofol     with fentanyl is advocated as the best anaesthetic combination for induction of anaesthesia     in patients undergoing CABG. Propofol is a drug with narrow therapeutic index and may cause     severe hypotension and hemodynamic instability during induction of anaesthesia, especially if     it is given in too large doses.      Automated drug delivery systems are popular for delivery of propofol. They can be of two     types, depending on whether they are based on pharmacokinetic or pharmacodynamic principles.     Closed Loop Anaesthesia Delivery system has been used world-wide and in our institute in     patients of various age groups and in patients undergoing cardiac surgery. But still the     studies are lacking in patients with moderate to severe left ventricular systolic     dysfunction. Moreover none of the studies have compared the efficacy of anaesthetic drug     delivery using these two devices in this group of patients.      Thus there is paucity of literature regarding PK and PD of propofol in patients with cardiac     failure. The investigators hypothesized that as the Closed Loop Anaesthesia Delivery System     is based on pharmacodyanamic principles, it should perform better than the Target Control     Infusion system, which works on pharmacokinetic principles. The investigators planned to     conduct this study to determine the anaesthetic depth control using Closed Loop Anaesthesia     Delivery system vs. manual control using Target Controlled Infusion in patients with moderate     to severe left ventricular systolic dysfunction.   "
48869|NCT02645981|"     Donafenib versus sorafenib for advanced hepatocellular cancer.   "
48872|NCT02645942|"     The investigators designed this intervention to investigate the potential role of L-C in     lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement     of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary     outcome) in OSA patients.   "
48873|NCT02645929|"     Our recent randomized controlled trial of psychotherapies for posttraumatic stress disorder     (PTSD) showed that Interpersonal Psychotherapy (IPT) benefitted patients. The mechanism of     action for IPT is unclear; unlike most PTSD therapies, it does not work through exposure to     trauma reminders. This assessment study will assess Symptom-Specific Reflective Function, a     measure of emotional awareness of one's PTSD symptoms, as a potential mediator of IPT,     capitalizing on naturalistic treatment of military veterans with PTSD at Columbia     University/New York State Psychiatric Institute.   "
48874|NCT02645916|"     The Purpose of this trial is to investigate the efficacy and safety of     Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity     in the Hands   "
48875|NCT02645903|"     Living donor organ transplantation has increased in recent years due to an increased need for     organs. The objective of this study was to investigate the effects of a TAP block on     postoperative analgesia and opioid consumption in liver transplantation donors in whom a     right lateral extending upper mid-line abdominal incision was used.   "
48876|NCT02645890|"     The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397     in healthy male volunteers.   "
48877|NCT02645877|"     This was a retrospective analysis of a cohort of all emergency care patients in Beijing from     January 2005 to December 2014. This aim of this study was to analyze the trends in     pre-hospital emergency care need and the emergency response times, with the intention of     aiding the government to optimize medical resources and improve pre-hospital emergency care.   "
48878|NCT02645864|"     Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal     squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from     that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant     pathological type in China and account for more than 95% cases in clinic. The prognosis of     ESCC is very poor. About 50% of patients have advanced disease at diagnosis with a 5-year     survival rate of only 5-7%. Though esophagectomy is standard treatment, disease will relapse     in many patients.      For patients with unresectable or recurrent disease, chemotherapy is an important treatment     alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported     effective in ESCC and is popularly used in first-line treatment of ESCC. However, there is     still no standard 2nd-line treatment for patients who fail in first-line treatment. Both     irinotecan and taxane had been studied as 2nd-line treatment for esophageal cancer patients.     But there are only a few of ESCC patients involved in those studies.      Except for chemotherapy, targeting treatment is another promising treatment for esophageal     cancer. In recent years, antiangiogenic treatment has been proved to be effective and     tolerable in many cancers such lung, colorectal, and gastric cancer. Apatinib is an also     known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data has shown     that it is effective in the treatment of a variety of solid tumors including esophageal     cancer. And it was approved and launched in China in 2014 as a 3rd-line treatment for     patients with advanced gastric cancer.      Therefore, investigators initialize this dose escalation phase I study to explore the safety     of irinotecan and apatinib combination treatment in ESCC patients with relapse disease after     esophagectomy and failure in 1st-line chemotherapy. Investigators will analyze the maximum     tolerated dose (MDT) and dose-limiting toxicity (DLT) in this study.   "
48879|NCT02645851|"     Rapid volume expansion using repeated intravenous fluid boluses is a very common intervention     performed in the intensive care unit (ICU) in the early days of resuscitation of patients     with shock. Once passed the initial phase of resuscitation, the fluid boluses administered     fail to effectively increase the patients' cardiac output in about 50% of cases. Pulse     pressure changes or stroke volume changes induced by a Passive Leg Raising (PLR) test have     acceptable/good ability to predict fluid responsiveness (in terms of cardiac output change)     and may be systematically used in patients with persistent shock with the aim of limiting the     total amount of fluid administered to patients by avoiding undue fluid boluses. One may     suppose that such a volume expansion management policy could impact morbidity and mortality     of shocked patients. Among the predictive indices available in clinical practice, the PLR     test has the advantages of being usable regardless of the patients' respiratory status and     cardiac rhythm. Changes in left ventricular stroke volume during the PLR test perform better     that changes in pulse pressure to predict fluid responsiveness. However, in counterpart,     pulse pressure changes during PLR can be assessed without the need of other hemodynamic     exploration such central venous pressure measurement or cardiac output monitoring. The     investigators hypothesized that strategies using either stroke volume changes or pulse     pressure changes induced by the PLR test to decide wether a fluid bolus clinically deemed     indicated should or should not be administered, may limit the amount of fluid received by the     patients during the first 5 days of shock, improve their oxygenation index, and shorten the     time passed under mechanical ventilation, as compared to a liberal strategy (usual care)     that does not use predictive indices of fluid responsiveness.   "
48880|NCT02645838|"     The purpose of this study is to determine whether or not motivational interviewing is     effective in smoking cessation at general practice setting in China.   "
49034|NCT02643797|"     This study is a cluster (clinic level) randomized pragmatic trial to compare the     effectiveness of MA Health Coaching (MAC) delivered by non-clinician primary care staff     (i.e., MAs) versus usual care (UC) in improving diabetes clinical control among individuals     with poorly controlled type 2 diabetes mellitus (T2DM).   "
48881|NCT02645825|"     Investigators need to establish a formal diagnostic of superficial adenopathy through     complementary investigations to find etiologic diagnostic ( Echography, adenogram).      Echography examination should be a guide to take in charge the adenopathy and to predict     presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of     this study is to codify the management of adenopathic patient with a diagnostic in 48 hours     after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting     time in case of a serious pathology.   "
48882|NCT02645812|"     Fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in     routine as well as research oriented clinical practice.      Various questionnaires measuring fatigue have been developed, but few have been validated in     french. MFI (Multidimensional Fatigue Inventory) has been validated in french in only one     study. BFI (Brief Fatigue Inventory) has been translated but never validated in french     language.      The main purpose of this study is to validate psychometrically the french version of BFI.   "
48883|NCT02645799|"     The main objective of this study is to assess the safety, efficacy and dose response of     LABR-312 administered intravenously at the time of percutaneous coronary intervention (PCI)     with a drug eluting stent in reducing restenosis as measured by Optical Coherence Tomography     (OCT) at 9 months post procedure in patients with diabetes mellitus (DM).      Administration of LABR-312 at the time of PCI will reduce restenosis compared with placebo as     assessed by the OCT endpoint of % neointimal hyperplasia (%NIH) volume at 9 months in     patients with DM.   "
48884|NCT02645786|"     The investigators evaluated the cardiac effects of Thyroid-stimulating hormone (TSH)     over-suppression in women with differentiated thyroid cancer (DTC) frequently encountered     during suppression therapy.   "
48885|NCT02645773|"     To investigate intervention with early application of non-ablative laser to prevent scarring     in the skin   "
48886|NCT02645760|"     The purpose of this study is to examines the effectiveness of Core stabilization exercise on     pain intensity at rest, functional disability, lumbar movement and ability to perform     repositioning tasks (joint position sense) in patients with subacute non-specific low back     pain.   "
48887|NCT02645747|"     The objective of this retrospective chart review is to evaluate drug utilization, usage     patterns and indication of effectiveness Eylea in the routine clinical (real-life) management     of patients who suffer from ME(Macular Edema), secondary to CRVO(Central Retinal Vein     Occlusion ), and who started treatment with Eylea for this indication.   "
48888|NCT02645734|"     In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to     receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose     of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .      The study drugs were administered as often as every 4 weeks for 3 months.monitoring of     best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence     tomography) was done from base line ,4 weeks, 8weeks after injection.   "
48889|NCT02645721|"     The purpose of this study is to determine whether extensive internet based cognitive behavior     treatment program with guidance is a more effective method to treat individuals with alcohol     use disorders than a briefer cognitive behavior treatment program without guidance.   "
48890|NCT02645708|"     The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to     eliminate stone completely, hastening fragments clearance just only rely on traditional     expulsive methods such as high fluid intake ,increasing physical activity, medical expulsive     therapy and changing body position. Therefore, researchers purpose to evaluate the     effectiveness of external physical vibration lithecbole(EPVL) in treatment of residual     fragments after RIRS by prospective study of clinical trial, which will improve stone-free     rate of residual fragments and benefit more patients.   "
48891|NCT02645695|"     Effects of the high frequent chest wall oscillation technique applied on the patients who     were intubated in intensive care unit were investigated.      A total of 30 patients who were intubated and under the mechanical ventilator supplied, were     included in the study. While the control group (n=15) received routine pulmonary     rehabilitation technique, the study group (n=15) was administered high frequency chest wall     oscillation for 72 hours as 4 times of 15-minute intervals, in addition to the pulmonary     rehabilitation technique. Patients 'APACHE-II scores, dry sputum weight, Lung Collapse Index     and blood gas values were measured at the hours 24th, 48th and 72nd, and endotracheal     aspirate culture was studied at initial and 72nd. In addition, patient outcomes were     evaluated at the end of the first week.   "
48892|NCT02645682|"     The purpose of this study is to investigate the effect of anti-infective central venous     catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically     ill patients in China, and the relationship between catheter-related bloodstream infection     and catheter-related thrombosis.   "
48893|NCT02645669|"     Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial     feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines     and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent     in the context of pathogenic mechanisms in periodontitis.   "
48894|NCT02645656|"     Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from     the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the     Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to     Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised     of curcumin, demethoxy curcumin and bisdemethoxycurcumin.   "
48895|NCT02645643|"     The doctor-patient relationship was becoming worse. More and more work-related violence has     happened to physicians and nurses. A portion of medical students felt depressed and thought     that the career future was gloomy. The study was designed to measure the empathy, an vital     element of professionalism, well-being of mental and study emotion. Furthermore, the     investigators explored an intervention of group study to promote medical students'     professionalism, mental health and study emotion.   "
49035|NCT02643784|"     This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the     efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.   "
49036|NCT02643771|"     The purpose of this study is to determine whether periodontal treatment improves the     periodontal clinical parameters in the periodontal patients with diabetes regarding     non-diabetics: two years follow-up.   "
48896|NCT02645630|"     Cervical spine manipulation has been found to be effective in patients with mechanical neck     pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual     intervention. In addition, some authors have proposed that spinal manipulation can alter     proprioception of the cervical spine. The aim of this study will be to investigate the     effects of cervical spine manipulation on pain, disability, widespread pressure pain     sensitivity, and cervicokinethesia in patients with mechanical neck pain.   "
48897|NCT02645617|"     The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.   "
48923|NCT02645266|"     Diabetic Macular Edema is a serious ocular consequence of poorly controlled diabetes. Even     though significant research has been done to clarify the pathogenesis of DME, a clear causal     pathway of the complication is of yet undetermined. However, there is some consensus among     researchers that a cascade of inflammatory markers plays an important role in the disease     process. Here we hope to better delineate the role these inflammatory markers play by     investigating whether basal levels predict response or lack thereof to Aflibercept.   "
48924|NCT02645253|"     This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the     safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics     [PD]) and how the body affects the drug (pharmacokinetics [PK]) when AZD7594 is given as     single and multiple ascending doses once daily by inhalation to healthy male Japanese     subjects, compared with placebo (non-active drug)   "
48925|NCT02645240|"     The study aims to identify several factors that can accurately predict the incident of     intestinal infraction in patients with mesenteric vascular occlusion or ischemia.   "
48926|NCT02645227|"     The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF)     and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony     defects in chronic periodontitis patients   "
48898|NCT02645604|"     Background: Malaria is a disease caused by a parasite. People get malaria if they are bitten     by an parasite-infected mosquito. A drug called artemether-lumefantrine (AL) can treat     malaria. Although iAL has helped make the malaria problem less severe in the African country     of Mali, researchers want to find out if malaria parasites are becoming resistant to this     drug.      Objective: To test for AL-resistant parasites in children with malaria in Mali.      Eligibility:      AL resistance monitoring study: children aged 2 17 years who live in Kenieroba, Mali, and     have malaria.      Blood collection substudy: healthy volunteers aged 18 65 years.      Design:      Volunteers for the substudy will have blood taken up to 6 times a year.      Study participants will be screened with 1 finger-prick blood sample. Girls may have a     pregnancy test.      Baseline visit: Participants will have a physical exam. Their vital signs and temperature     will be measured. They will answer questions about their symptoms. They will give a blood     sample.      Participants will get 6 doses of AL over 3 days. They will take it in tablet form with milk.      Some participants will also stay at the clinic for 2 days. They will have a catheter placed     in a vein. They will have blood taken frequently.      Participants will have follow-up visits for about 1 month. They may have:      Physical exam performed      Vital signs and temperature measured      Symptom questionnaire administered      Finger-prick blood sample and/or a regular blood sample taken      Pregnancy test given      Antimalarial medications other than AL provided.   "
48899|NCT02645591|"     The goal of this clinical research study is to learn about the safety and the effectiveness     of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help     improve the return of erectile function and bladder control in patients after robotic     assisted laparoscopic radical prostatectomy (RARP).      dHACM is a section of tissue made from part of the placenta donated by a mother during a     C-section. It looks like a small piece of tissue paper and is wrapped around the nerve     bundles in the surgical area. The tissue may help the body's normal healing process.   "
48900|NCT02645578|"     This study is a prospective multicenter randomized controlled trial from Asian countries to     compare the effect and safety of right median nerve stimulation versus traditional treatment     for comatose patients at the early stage following traumatic brain injury.   "
48901|NCT02645565|"     This study will be conducted to find out whether low dose or high dose cyclophosphamide     therapy is effective in the treatment of proliferative lupus nephritis.It will also compare     the side effects and risks of infection in low dose and high dose cyclophosphamide group.     Half of the participants will receive a low dose cyclophosphamide for 3 months and half will     receive high dose cyclophosphamide therapy monthly for 6 months followed by azathioprine 2     mg/kg.   "
48902|NCT02645552|"     This study is a prospective single-centre randomized trial to compare the effect of     tranexamic acid versus placebo in the pre-hospital management of patients with moderate and     severe traumatic brain injury.   "
48903|NCT02645526|"     The aim of the present study is to assess the effectiveness and the safety of a woolen cap in     maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care     (KMC).   "
48904|NCT02645513|"     The purpose of this study is to assess whether twice-daily text message reminders over a     six-month period to health workers in Malawi about diagnosis and treatment of malaria,     pneumonia, and diarrhea improve case management of these diseases.   "
48905|NCT02645500|"     In this study, the investigators would use the training workshops as a capacity build method     to deliver the holistic health knowledge for the trainers and ambassadors implementing and     assisting the community-based programs for the public. The investigators hypothesize that the     training workshops and mobile health messages would promote the health awareness and the     health of the participants. The investigators would expect the participants influence the     health behavior and attitude of their family members.   "
48906|NCT02645487|"     SRS dose escalation for brain metastases in radiation-naïve patients will establish true     tolerable doses, which may exceed the current standard doses. This may lead to an improvement     in local control, patient survival, and/or quality-of life.   "
48907|NCT02645474|"     Two regional anesthesia techniques already in use in common clinical practice -paravertebral     block and pectoral nerve block (PECS block) are compared in a randomized, double-blind,     multicenter, controlled, non-inferiority trial, in order to compare their success rate in     patients udergoing breast surgery.   "
48908|NCT02645461|"     Amyotrophic lateral sclerosis (ALS) is a fatal disease leading to motor neuron degeneration     and progressive paralysis. Other studies have revealed defects in skeletal muscle even in     absence of motor neuron anomalies, focusing on acetylcholine receptors (AChRs) and supporting     the so-called dying-back hypothesis. Outcome of this study will be to understand if the     endocannabinoid palmitoylethanolamide (PEA) can reduce the rundown of AChRs currents in ALS     muscle, and if it can modify ALS patients' clinical and electrophysiological parameters.   "
48921|NCT02645292|"     The worldwide epidemic of physical inactivity is rising significantly and the main cause is     sedentary lifestyle. In this era of globalization and rapid advancement of technology, people     are chasing after worldly matters, leading them to abandon the most important factor in their     life and that's their body. Most people are leading a sedentary lifestyle as they indulge     themselves in their never-ending work. There is a significant lack of awareness on the     importance of physical activity and cardiorespiratory fitness to health as people are     focusing more on factors such as smoking, cholesterol and hypertension. The purpose of this     study is to evaluate the effectiveness of stair climbing (SC) and 1 mile walking (1MW) in     relation to cardiorespiratory responses and fitness.   "
48922|NCT02645279|"     The purpose of this study is to demonstrate the effectiveness of oral glucose administration     during MRI for imaging of newborns and compare with midazolam sedation.   "
48927|NCT02645214|"     This study is a prospective, blinded, randomized, controlled trial (RCT) with a crossover     design to determine if antiseptic-impregnated surgical scrubs decrease the burden of     healthcare providers (HCP) clothing contamination compared to standard, control surgical     scrubs following a 12-hour ICU shift.   "
49114|NCT02642757|"     This study evaluates the effectiveness of a brief intervention for the reduction of alcohol     use among risky alcohol users in primary care delivered by paramedics. Half of the     participants will receive a brief intervention and half will receive written guidelines on     safe alcohol use.   "
48909|NCT02645448|"     The aim of this study was to investigate and correlate the glucose responses and VFC 24 hours     after resistance exercise (RE) sessions at different intensities in women with type 2     diabetes (DM-2). Twelve women with DM-2 were invited to perform by one week in randomized     order, two weeks interventions with experimental sessions: Session Control (CONT) without     conducting RE, RE session (40% or 80% of one maximum repetition - 1RM) on day 2 and day 3 was     observed the effect of the length of RE session by 11h. After that, initiated the     experimental sessions, where after each of the analysis of glucose 24h by continuous     monitoring system of glucose was performed, considering breakfast, lunch, dinner and sleep,     and analysis performed of the RR series by a period of 48h. During control sessions, the     subjects were seated comfortably for 40min and RE sessions, 40%1RM and 80%1RM, were performed     in medium circuit 3 sets with 16 and 8 replications and recovery range between 60 exercises     and 90seg , respectively, and between the circuits 120sec. It was observed that the     concentration of glucose in the period of 24h after the session has been reduced to 40% 1RM     vs. CONT and 80%1RM. Hyperglycemia was prevalent in the period 34h of the sessions CONT and     80%1RM, respectively , being different from the session 40%1RM. In postprandial times,     shorter hyperglycemia was found in the session to 40% 1RM vs. CONT and 80% 1RM after     breakfast, lunch and dinner. At the time of sleep, less time in hyperglycemia was found     between sessions of 40% 1RM vs. 80% 1RM. Significant correlations (p <0.01) were found     between glucose 24h with cardiac autonomic RRi variables, HF, LF and reason LF:HF.   "
48910|NCT02645435|"     Background:      Direct anterior approach to the hip (DAA) is being considered as one of the most promising     minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to     analyse influence of learning curve on clinical and radiographic outcome in direct anterior     approach (DAA) for total hip replacement.      Methods:      The first 30 patients operated with DAA (group B) were compared to 39 patients operated by     Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS),     implant positioning, experienced pain and patient satisfaction were evaluated at a mean     follow-up of 32 months.   "
48911|NCT02645422|"     The aim of the present study is to identify new obesity-related genetic defects and determine     their association with clinical manifestations in families with childhood-onset severe     obesity. The investigators hypothesize that by exploring children with severe early-onset     obesity they can find new obesity-related genetic defects and by exploring obesity-associated     clinical manifestations the investigators can elucidate the outcomes of severe childhood     obesity.   "
48912|NCT02645409|"     Primary      • To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy     at the margins of resection, and in lymph node(s) or other metastases during radical     nephrectomy.   "
48913|NCT02645396|"     The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV)     infection in newborns born to seropositive women.   "
48914|NCT02645383|"     The aim of this study is to compare the severity of expressed pain scores in patients with     PDR who underwent either PASCAL or conventional laser and to assess the association between     patient characteristics and severity of pain.   "
48915|NCT02645370|"     The purpose is to evaluate the effectiveness and safety profile of Danzhen for the     prophylaxis of migraine in a real-world setting.   "
48916|NCT02645357|"     Implementing an evidence-based computerized decision support system linked to electronic     health records to improve care for cancer patients.      The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel     group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study     Center(s) Single-center      Objectives:      The primary outcome of this trial is a process outcome. i.e. the rate at which the issues     reported by the reminders are resolved (resolution rates).   "
48917|NCT02645344|"     The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation     (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on     reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of     activities of daily living (ADL). Sixty subacute patients with left UN after     right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS     alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the     contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the     hemiplegic arm, five days per week for two weeks. The first two groups received the same     dosage of conventional rehabilitation on top of their experimental interventions. Blinded     assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up     upon completion of training.   "
48918|NCT02645331|"     The aim of this study was to determine the effects of an innovative child-friendly     remind-to-move treatment (RTM) treatment by comparing it with constraint-induced movement     therapy (CIMT) on upper extremity outcomes in children with hemiplegic Cerebral Palsy. In an     evaluator-blinded randomized controlled trial, 73 children, among of whom 20 in Manual     Ability Classification System level I, 38 level II, and 15 level III, were recruited from 3     special schools and randomized to receive 75-hour RTM (n=25) and CIMT (n=24) programme over     15-weekdays, and conventional treatment (n=24). The primary outcomes were Jebsen-Taylor Hand     Function Test (JTHFT) and Bruininks-Oseretsky Test of Motor Proficiency (BOTMP-II) Subtest 3     for assessing the motor efficiency at baseline, posttest, and 1- and 3-month follow-up.   "
48919|NCT02645318|"     Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via     targeted DNA sequencing in surgical NSCLC patients.   "
48920|NCT02645305|"     Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases     including chronic bronchitis, emphysema and chronic obstructive airways disease. People with     COPD have difficulties breathing, primarily due to the narrowing of their airways, this is     called airflow obstruction.      Some preclinical evaluations showed that COPD is closely related to chronic inflammation;     therefore, this study aimed to use adipose-derived stem cells (ADSCs) in the form of     non-expanded culture - that usually names as a stromal vascular fraction (SVF) in combination     with activated platelet rich plasma (PRP) to treat this disease. Both SVF and PRP are     autologous sources that obtained from adipose tissue and peripheral blood, respectively. This     mixture is intravenously transfused into the patients.   "
48935|NCT02645110|"     The purpose of this study is to evaluate the effectiveness of whole-natural hand-wash     formulations in bacterial removal and to estimate the relative mildness of the formulations.   "
48928|NCT02645201|"     The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are     marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori     eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory     properties of the second strain.      Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to     an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication     rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori     bacteria.   "
48929|NCT02645188|"     Do specific verbal and tactile cues and instructions help people who perform bridging     exercises to improve hip muscle strength to optimize recruitment of the gluteus maximus     muscle?   "
48930|NCT02645175|"     A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile     and ability of TW1025 oral solution to decrease fatigue in HER2-negative metastatic breast     cancer patients receiving chemotherapy.   "
48931|NCT02645162|"     Worldwide about 88 million children drop out of primary school annually. One of the     contributory factors is a lack of school readiness among young children, their families and     their teachers. To better prepare young children for school, investment in early childhood     interventions is necessary. Young children require good health, adequate nutrition and     social-emotional, cognitive and communication skills to succeed in school, which requires     both support in the family environment and a stable transition to the classroom environment.     Preschool programmes are designed to prepare children for formal learning. However, in many     low- and middle-income countries there is poor access to quality preschool programmes.     Further, the scale-up of early childhood interventions is challenged by a number of barriers     such as poor supply (e.g. policy provisions, financing, distance, early child development     workforce), inadequate cross-sector coordination, low demand (e.g. knowledge mobilization,     agency, community of purpose, opportunities to participate) and weak quality of services     (e.g. training, supervision and monitoring systems).      In partnership with the National Commission for Human Development, we propose to implement an     early childhood care and education programme in rural Sindh that is championed by Community     Youth Leaders. The Community Youth Leaders will run community preschools for children aged     3-6 years, and will also coordinate local community engagement and local stakeholder     strategies across sectors to leverage demand-side actions to promote ownership and scale-up     of early childhood interventions. The LEAPS Programme (Youth Leaders for Early Childhood     Assuring Children are Prepared for School) will be evaluated by a cluster randomized     controlled efficacy trial. The primary outcome will be children's school readiness, indexed     by both early academic and social emotional competencies assessed following 6-9 months of     intervention exposure. The compliance, fidelity and quality of the implementation process     will also be assessed in order to understand how these features moderate outcomes and whether     community-engagement strategies facilitate demand-side actions for scale-up. The expected     outcomes for this trial will include a model for quality preprimary education that addresses     a current supply-side gap, and will facilitate learning for demand-side actions to support     scale-up across a broad range of early childhood interventions.   "
48932|NCT02645149|"     This is a patient oriented translational research project aiming to improve clinical outcomes     for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV metastatic     melanoma who have progressed on, or are unable to receive standard therapy (in general,     immunotherapy). Consecutive patients seen at three major clinics and fitting the broad     eligibility criteria will be invited to participate.      The approach is designed to test the impact of different targeted drugs on different     mutations in a single type of cancer. In this project, patients will have tumour tissue     genetically profiled to determine which mutation(s) are present, and will then be assigned to     receive a matched drug expected to target the mutation(s) in the tumour. Where multiple     targets are identified in one patient, or where multiple potential therapies would be     appropriate for a single tumour mutation, the treating clinician may determine the     appropriate therapeutic approach after consultation with the study team, using the latest     version of library of matched therapies.   "
48933|NCT02645136|"     The purpose of this study is to compare the efficacy between a Pilates exercise program and a     Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES)     in muscular pressure strength of the pelvic floor as conservative treatment of urinary     incontinence after prostatectomy.   "
48934|NCT02645123|"     Introduction: patients with chronic back pain as a result of degenerated disc disease,     besides pain also present with impaired gait. The purpose of this study is to evaluate both     the clinical data using clinical rating scales, such as Oswestry Disability Index Greek     version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the     Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic     characteristics during gait analysis in patients with chronic low back pain as a result of     the degenerated disc disease (Disc Degenerative Disease), before and after application of     manual therapy techniques.      Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain     were randomly divided into 3 groups of 25 each. Each group received five sessions with the     first group receiving manual therapy treatment (spinal mobilisation), the second a sham     treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To     evaluate the effectiveness of each treatment, the visual analog pain scale, two     questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording     and analysis of gait (kinetic and kinematic data) were utilized.   "
48937|NCT02645084|"     In this trial the investigators will evaluate the effectiveness of the implementation of a     digital familial risk questionnaire in the detection of CRC patients with hereditary or     familial CRC. This will be done using a stepped wedge design with 5 participating hospitals     for a duration of 1.5 years. A comparison is made between an intervention phase (offering the     online risk assessment questionnaire) and a control phase (hospital-based standard practice     for the detection of CRC patients with hereditary or familial CRC, informed by the referral     criteria that are being used in the intervention group). All patients with a diagnosis of CRC     who have a first appointment at the CRC outpatient clinic will be included. The primary     outcome is the percentage of all included patients who receive a recommendation for regular     surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical     geneticist. Data from clinical geneticists is being used to answer this question.   "
48951|NCT02644902|"     The Thinking Healthy Program is evidence based psychological intervention, delivered by     non-specialists, with proven impact on maternal depression. A major challenge in the scale-up     of this intervention, especially where health systems are weak, is providing quality training     and supervision at scale. Women living in post-conflict areas are at a higher risk of     depression than the general population.The key innovation proposed is the development and     evaluation of a technology-assisted cascade training and supervision system to assist     scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.   "
49202|NCT02641613|"     Patients will be randomized to one of two groups:        1. Supraclavicular group: supraclavicular brachial plexus block performed with the aid of          ultrasound;        2. Retroclavicular group: retroclavicular brachial plexus block performed with the aid of          ultrasound.   "
48938|NCT02645071|"     Lack of physical activity was found to be a local and worldwide issue. Most Hong Kong people     are having sedentary lifestyle. Researchers show that the increase of physical activity     reduces the risk of chronic diseases, and improve cardio-pulmonary functions; whereas     sedentary behaviors increase the risks.      For many people, the targets of the WHO physical activity guidelines are too high to be     achieved. Some people are not even willing to try, despite the evidence for the protective     benefits to their long term health. In response, a recent focus has been placed upon     reduction of sedentary behavior. Sedentary behavior is defined as 'those activities that do     not increase energy expenditure substantially above the resting level, such as sitting, lying     down, or viewing TV, or simply as too much sitting. The primary determinants of sedentary     behavior are behavioral and context-based, such as TV and screen-focused behaviors in home     and work environments, sitting at work, and sitting during transport. The public health     leaders have called for reducing the time spent in sedentary behaviors as a possible public     health priority. This study will focus on reduction of sedentary behavior and increasing     physical activity in daily life. We hypothesize that the training programs would promote the     health awareness of the participants.   "
48939|NCT02645058|"     To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL     (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20     mm size.   "
48940|NCT02645045|"     In this study, the investigators aim to determine the effects of age, sex, history of ocular     surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid     layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with     dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant     will underwent LLT measurement with a LipiView interferometer, tear meniscus height     measurement using optical coherence tomography, tear film break-up time (TBUT) determination,     corneal and conjunctival staining, Schirmer's test, examination of the lid margins and     meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.   "
48941|NCT02645032|"     This is a Phase I, Randomized, observer-blinded, age de-escalating study.      The study objectives are      to evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4     weeks.      to assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0     and 4 weeks.      to compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.   "
48942|NCT02645019|"     A prospective study designed to access changes in the intracuff pressure of a laryngeal mask     airway (LMA) or cuffed endotracheal tube (cETT) during placement of an     esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.   "
48943|NCT02645006|"     The purpose of this study is to determine whether a primary prevention workshop is effective     decreasing at least 13% the annual incidence of falls in elderly compared to the habitual     counseling.      Before the first fall incident, the elderly aged 65 or more, living in community, are invited     to attend a workshop on fall preventing activities and factor risk detection. This activity     consists on four sessions (one session per week during three weeks and the fourth session one     year later) in which the elderly are expected to detect their own fall risk factors,     encouraged to introduce healthy habits and to increase physical activity in order to improve     strength and balance specifically.      This workshop has been prepared by family physicians following the latest scientific     recommendations, it will be lead by them on the first edition, but it has not been written in     formal language in order to be used by volunteers concerned about aging topics, independent     from the Health Service.   "
48944|NCT02644993|"     The study aim of this study is to evaluate the effect of proton therapy on quality of life     and long-term normal tissue toxicities of the pediatric cancer patients. Based on these     results, the predictive model of long-term normal tissue toxicities, survival, and quality of     life could be recognized. Risk-adapted treatment strategy based on the predictive model in     pediatric cancer patients could be established.   "
48945|NCT02644980|"     For patients requiring the heart valve replacement surgery, heart function is injured in     different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular     system has important clinical meanings. Etomidate has slight effect on the cardiovascular     system, often used in the induction of anesthesia, however target controlled infusion     etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe the     application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.   "
48946|NCT02644967|"     The goal of this clinical research study is to find the highest tolerated dose of the study     drug IMO-2125 that can be given in combination with ipilimumab or in combination with     pembrolizumab to patients with metastatic melanoma. Researchers also want to learn if the     study drug combination can help to control the disease. The safety of the drug combination     will also be studied.   "
48947|NCT02644954|"     Psoriasis vulgaris is a common, chronic, relapsing skin disease characterized by predominant     involvement of skin, nails and joints. Recent advances in its patho-physiology have shifted     the notion of psoriasis from that of a 'disease of the skin' to a 'T-cell mediated systemic     disease'. Better understanding of its pathogenesis and co-morbidities along with the     development of novel therapeutics like biological response modifiers has changed the way     dermatologists approach the management of psoriasis. Based on the extent of involvement and     effect on the quality of life, psoriasis may be mild to moderate in severity. This in turn     forms the basis of treatment in majority of the patients. Topical therapies like coal tar,     calcipotriol and corticosteroids are sufficient for mild and localized psoriasis. In more     widespread or severe forms that are associated with significant decrease in quality of life     of patient, phototherapy and systemic therapies are indicated either alone or in combination     with each other. Although the introduction of biological therapies has revolutionized the     treatment of psoriasis in recent years, such newer therapeutic options continue to elude the     vast majority of patients in the developing and under developed world where the traditional     agents like methotrexate, cyclosporine, acitretin and phototherapy still form the backbone of     treatment.      The association of psoriasis with metabolic syndrome is now well documented. Metabolic     syndrome is a cluster of risk factors including central obesity, atherogenic dyslipidemia,     hypertension and glucose intolerance and is a strong predictor of cardiovascular diseases,     diabetes and stroke. Metformin, an oral hypoglycemic agent of biguanide class is known for     its multitude of action on various facets of metabolic syndrome. Recently it has also been     found to inhibit keratinocyte proliferation in cell culture model of psoriasis.      The present study is designed as a randomized controlled double blind pilot study in which 40     patients with chronic plaque psoriasis of moderate severity (PASI ≥ 6 or DLQI ≥ 6) and     metabolic syndrome (By modified ATP III criteria)4 or impaired glucose tolerance (defined as     two-hour glucose levels of 140 to 199 mg per dL on the 75-g oral glucose tolerance test) will     be recruited and randomized into two arms, A and B of 20 each, by using random number tables.     Patients in arm A will be treated with topical anti-psoriatic treatment (including coal tar     and vitamin D3 analogues only) and oral metformin 1g/day 850mg twice daily and patients in     arm B will be treated with topical anti-psoriatic treatment and oral placebo tablets. Post     randomization patients will be followed up at regular intervals for 24 weeks. During each     visit, patients in both arms will be assessed for the severity of psoriasis by psoriasis     activity severity index (PASI) and body mass index (BMI). Fasting blood glucose and insulin     level, glycosylated haemoglobin (HbA1c) and parameters of metabolic syndrome (including waist     circumference, fasting lipid profile and blood pressure) will be assessed at baseline and     again at week 16 and 24. The primary aim of this study is to assess the efficacy and safety     of oral metformin as an add on therapy for the treatment of chronic plaque psoriasis of     moderate severity. The secondary aim is to assess the effect of metformin on parameters of     the metabolic syndrome.   "
48948|NCT02644941|"     The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE     grafts when used for hemodialysis access.   "
48949|NCT02644928|"     This study is designed as a prospective, single-center, longitudinal and analytical study on     the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).   "
49072|NCT02643303|"     This is an open-label, multicenter Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and     the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment     (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable,     biopsy-accessible cancers.   "
48950|NCT02644915|"     Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after     kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone     is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments     have revealed its beneficial effects against I/R injury, our goal is therefore to investigate     the effectiveness of a recipient pretreatment with Edaravone at reducing the occurrence of     DGF after kidney transplantation.   "
48952|NCT02644889|"     This study has been designed in order to detect EGFR mutation abundance of tissue and     concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with     Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate     the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and     prognosis.   "
48953|NCT02644876|"     Postoperative pulmonary complications (PPCs) are major causes of postoperative morbidity,     mortality, and prolonged hospital stay.The incidence of PPCs may be as high as 41% to 75% in     high-risk patients. Bronchodilator is frequently used in high-risk patients to prevent PPCs.     Penehyclidine is a new anticholinergic agent which selectively block M1 and M3, but not M2     receptors. A pilot study of the investigators showed that prophylactic penehyclidine     inhalation reduced the incidence of bronchospasm and the use of aminophylline in elderly     patients after long-duration surgery. The purpose of this study is to investigate whether     prophylactically penehyclidine inhalation could decrease the incidence of PPCs in high-risk     patients after major intrathoracic and upper intraabdominal surgery.   "
48954|NCT02644863|"     This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy     after resection of esophageal cancer   "
48955|NCT02644850|"     To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT)     single photon emission computed tomography (SPECT) with planar equilibrium radionuclide     angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.   "
48956|NCT02644837|"     This study will look at key performance indicators of 2 supraglottic airway devices in     anaesthetised adults in a crossover manner.   "
48957|NCT02644824|"     Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low     cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased     and emphasis has shifted to post-operative morbidity and recovery. Children with CHD     undergoing surgery with CPB can experience well-characterized post-operative cardiac     dysfunction. When severe, patients can develop clinically important low cardiac output     syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is     primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which     affect the strength of the heart's muscular contractions. These are used to maintain adequate     blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to     myocardial function and may increase risk for post-operative arrhythmia and impair     post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2).     In combination with the increased VO2 associated with CPB-induced systemic inflammatory     response patients can develop a critical mismatch between oxygen supply and demand,     essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic     stability without increased VO2 are beneficial. This study will test whether BiVp, a     specialized yet simple pacing technique, can improve post-operative CI and recovery in     infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes     that Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants     with EMD following CHD surgery compared to standard care alone.   "
48958|NCT02644811|"     The purpose of this trial is to study and compare two different anchorage techniques.     Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both     groups are treated with extractions of the maxillary first premolars and fixed appliance.     Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.      The hypotheses are:        -  that placement of miniscrews does not cause more pain or discomfort than premolar          extractions        -  that molarblock provides increase of anchorage        -  that miniscrews have a better anchorage capacity than molarblock        -  that miniscrews are more cost-efficient than conventional anchorage techniques   "
48959|NCT02644798|"     Few patients who have major risk factors develop Acute Respiratory Distress Syndrome (ARDS).     The heritable determinants might be the reason. The multicenter study is to investigate the     association between ARDS and polymorphism in ARDS gene r.   "
48960|NCT02644785|"     The investigators aim to assess tryptase test efficacy for measuring the allergic response to     protamine during cardiac bypass surgery. Additionally, the investigators aim to establish a     differential diagnosis on the basis of potential allergens or clinical causes.   "
48961|NCT02644772|"     The purpose of this study is to determine whether the investigators can predict which     patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung     capacity during the initial exacerbation.   "
48962|NCT02644759|"     Type 1 diabetes mellitus (T1DM) is a chronic, autoimmune condition that involves the     progressive destruction of pancreatic β-cells, eventually resulting in the loss of insulin     production and secretion. Hence, an effective treatment for T1DM should focus on controlling     anti-β-cell autoimmunity, combined with regeneration of lost pancreatic β-cell populations,     with minimal risk to the patient.      This is a phase I and II clinical trial for treatment of patient with confirmed diagnosis of     T1DM for at least 12 months prior to enrolment in this trial. This study aims to determine     the combined effects of autologous stem cell transplantation and immunomodulation, on     regeneration of lost β-cells and halting the immune attack on the pancreatic β-cells,     respectively.   "
48963|NCT02644746|"     Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the     primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective     for DLSS but the evidence is poor. Therefore, an objective assessment of acupuncture efficacy     is critical for making informed decisions about its appropriate role for patients. A total of     80 participants meet prior inclusion criteria will be recruited. The participants will be     allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group randomly.     Twenty-four treatments will be provided over 8 weeks. The primary change of Modified     Roland-Morris Disability Questionnaire (RMDQ) and secondary outcomes including the change of     Number Rating Scale (NRS); the change of Self-paced Walking test (SPWT); the change of Swiss     Spinal Stenosis Questionnaire (SSSQ); the expectations that acupuncture might help     participants with DLSS. All outcomes will be assessed at baseline, and/or after 4, 8, 20 and     32 weeks. Statistical analysis will include independent sample t-test, Chi-squared test and     non-parametric test. The investigators hope the result of this trial will clarify the value     of acupuncture for DLSS and help clinicians make proper decisions.   "
48964|NCT02644733|"     Measuring intraabdominal pressure in the semi-recumbent position and supine position.   "
49133|NCT02642510|"     The purpose of this study is to evaluate the impact of a structured, DVD educational     intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The     focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their     family members. Outcome variables will be the patient and family member's satisfaction with     inpatient teaching and anxiety about inpatient treatment.   "
48965|NCT02644720|"     Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they     can bring about halos and glare, which are caused by design deficiencies of the IOLs.     Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may     increase the difficulty of neural compensation reconstruction in patients with multifocal     intraocular lens implantation. Patients enrolled into the study will be followed for 1 year     and will have study visits preoperatively, at 1 week, 3 months, 6 months, 12 months     postoperatively.In this trial, we aimed to specify the time of neural compensation     reconstruction in patients and to explore the changes of visual function in senile patients     with monofocal or multifocal intraocular lens implantation.   "
48966|NCT02644707|"     To investigate whether the supplementation of organic selenium at the adult dose (200 mcg     per day in the form of L-selenomethionine) has a favorable impact on thyroid function,     including the titer of anti-thyroid antibodies [Anti-thyroid peroxidase (anti-TPO) and     Anti-thyroglobulin (anti-Tg) antibodies], in children and adolescents with autoimmune     thyroiditis (AT).   "
48967|NCT02644694|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate     ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients     undergoing vitrectomy for macular hole repair or epiretinal membrane peeling   "
48968|NCT02644681|"     The primary objective of this study is to evaluate if the motor-evoked potentials/motor     action potential amplitude ratio and motor action potential amplitude measurement are useful     in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery.      The secondary objective is to evaluate the presence of a correlation between     neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and     physiologic changes) in order to find which factor is the most important in determining     spinal cord ischemia.      This study is an observational, single-center, prospective study on patients with     thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative motor-evoked     potentials and somatosensory evoked potentials monitoring.   "
48969|NCT02644668|"     The primary objective of this study is to demonstrate a pharmacodynamic effect of CK-2127107     on measures of skeletal muscle function or fatigability in patients with Spinal Muscular     Atrophy Types II-IV.   "
48970|NCT02644655|"     Objectives:      The purpose of this study is to evaluate the safety and prognosis of New Cluster of     Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of     recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.      Methods:      This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled.     Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4     days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According     to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long.     Follow-up survey after the clinical study: within 1 months, once a week; then once a month     for 1 years; and then once a year, a total of 15 years.   "
48971|NCT02644642|"     Lung isolation technique is useful for lung or heart surgeries for better visualization.     Double lumen endobronchial tube and bronchial blocker are available for lung isolation.     Adding disconnection technique before lung isolation is helpful to accelerate the lung     deflation. However, the utility of disconnection technique has never been evaluated in     comparison of double lumen tube and bronchial blocker. Therefore, the utility of     disconnection technique in two different lung isolation technique, double lumen tube and     bronchial blocker will be evaluated   "
48972|NCT02644629|"     The current study wishes to contribute to the applicability of the use of ketamine in a     clinical setting by focusing on the efficacy of intra-nasal administration compared with the     IV route.   "
48973|NCT02644616|"     The investigators research the early improvement of fluid retention and mid-term prognosis     through the administration of tolvaptan for the patient with tricuspid regurgitation and     right heart failure after left heart valves replacement.   "
48974|NCT02644603|"     The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol     versus conventional treatment on patients who underwent liver resection for hepatocellular     carcinoma(HCC).   "
48975|NCT02644590|"     Nocturnal hypertension is recognized via ambulatory blood pressure monitoring in adolescents     with type 1 diabetes mellitus.      Melatonin, (as previously seen in earlier studies in adults), may alter these changes, which     may be a benefit especially for patients with diabetes mellitus who are at risk for     cardiovascular changes.      The purpose of this study is to estimate the use of melatonin as treatment for nocturnal     hypertension in young adults with type 1 diabetes melitus.   "
48976|NCT02644577|"     The purpose of this study is to test the efficacy of metformin for treatment     antipsychotic-induced metabolic syndrome in bipolar disorder patients.   "
49124|NCT02642627|"     This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety     of Bellafill for correction of distensible atrophic acne scars in the full facial area. All     enrolled subjects will receive initial treatment with Bellafill, as well as touch-up     treatments (if necessary to achieve optimal correction). Subjects will be evaluated at     Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.   "
48977|NCT02644564|"     The purpose of the study is to determine whether the introduction of early ultrasonography     screening will change the diagnostic spectrum of soft tissue shoulder injuries in patients     aged forty years or more. We also want to study whether certain physical tests will be able     to predict or rule out full-thickness tears of the rotator cuff (shoulder tendons) in the     acute phase. Another purpose is to explore the course of soft tissue shoulder injuries over a     year, as well as to compare the results to studies on the prevalence of rotator cuff     full-thickness tears.   "
48978|NCT02644551|"     This will be an interventional safety and efficacy study of CELENT07 when used as a topical     treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This     is randomized, double-blind, parallel design, placebo and active controlled study in patients     with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects     will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for     52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical     efficacy and safety and tolerability.   "
49203|NCT02641600|"     Patients with chronic venous disease causing pain or ache will be randomised into two groups,     active stockings (18-21 mmHg) or placebo stockings   "
48979|NCT02644538|"     This study evaluates whether PegIFN alfa-2a add on can improve CHB patients HBsAg clearance     at the end of 48 weeks treatment. The CHB patients who received nucleot(s)ides anti-virus     treatment and reached HBV DNA<1000 copies/ml and HBsAg<3000 IU/ml, were randomly assigned     into two groups: One group continue the nucleot(s)ides treatment for 72 weeks, the other add     on PegIFN alfa-2a on the basis of the original treatment for 48 weeks, and follow up for 24     weeks.   "
48980|NCT02644525|"     Background:      Many people who live in west or central Africa are at risk for infection from a very small     worm called Loa loa. This infection is acquired through the bite of a fly. Baby worms called     microfilariae live in the blood. The infection most commonly causes skin itching, mild     temporary limb swelling, and sometimes a adult worm can be seen in the white of the eye of an     infected individual. Very rarely, people with this infection can develop problems with the     kidneys and heart as a result of the worm s effect on the immune system. Because the vast     majority of people with the infection have minimal symptoms, people in Cameroon usually do     not get treated. But infection with Loa loa can cause serious problems in people who are     being treated for infections with other parasites (namely, river blindness and lymphatic     filariasis). Researchers want to find out of a drug called imatinib can treat Loa loa     infection so that patients with this infection can safely receive other drugs to cure river     blindness and lymphatic filariasis. Researchers believe imatinib can be a safe drug to use on     Loa loa, because in the lab this drug kills the worms slowly, whereas other drugs which can     cause treatment reactions usually kill the worms very quickly.      Objective:      To test if imatinib can treat Loa loa infection by killing the worms slowly.      Eligibility:      People ages 18 65 with non-severe Loa loa infection who are otherwise healthy      Design:      Participants will be screened with a physical exam and blood and urine tests.      Participants will have a baseline visit. This will include a physical exam and blood and     urine tests. It may include a stool sample. Participants will be randomly assigned to get 1     dose of either imatinib or a placebo      Participants will return to the clinic every day for 1 week, then once a week for 3 weeks.     Visits will include a physical exam and blood tests. They will have urine tests in the first     week.      Participants will have follow-up visits 3, 6, and 12 months after taking the imatinib or     placebo. These include a physical exam and blood tests. They may include urine and stool     samples.      If participants develop side effects, they will be treated for them.   "
48981|NCT02644499|"     This study will be conducted to find out how well a patient of rheumatoid arthritis (RA) will     respond to disease-modifying antirheumatic drugs (DMARDs). RA is a chronic inflammatory     arthritis, which leads to joint damage & disability if not treated properly. A DMARD is used     to treat RA that slows down or prevents joint damage, as opposed to just relieve pain or     inflammation by painkillers. The study will be conducted at the Department of Clinical     Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education & Research).     Patients will receive either a single DMARD (Methotrexate) or combination DMARDs therapy     (Methotrexate + Leflunomide + Hydroxychloroquine). During treatment course, routine blood     investigations will be carried out to monitor treatment response and side effects.   "
48982|NCT02644486|"     To observe the decreased levels of low-density lipoprotein from baseline in patients with     obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.   "
48983|NCT02644473|"     To evaluate whether there is a difference in symptomatic thromboembolism events in the subset     of patients with a history of, or risk factors for thromboembolic disease for topically     applied tranexamic acid in total joint arthroplasty.   "
48984|NCT02644460|"     This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin     dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse     intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant     brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).   "
48985|NCT02644447|"     Cellular therapies are rapidly progressing fields and have shown immense promise in the     treatment of damaged ovarian function. The purpose of this study is to determine safety and     efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold     in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of     HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.   "
48986|NCT02644434|"     The purpose of the present study is to investigate if intentional strategy (a more aggressive     side branch protection strategy: elective two-stent or jailed balloon technique) is     associated with significant reduction of side branch occlusion rate compared to conventional     strategy (provisional two-stent strategy or jailed wire technique) in patients at high risk     of side branch occlusion (V-RESOLVE score≥12).   "
48987|NCT02644421|"     Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single     intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will     be administered as a positive control. The study will take place during a single inpatient     visit involving three separate treatment periods, each with a washout of (>16-hours. Study     drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.   "
48988|NCT02644408|"     Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can     improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance     put, chemotherapy, improve the quality of life, is widely used in tumor radiation and     chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal     bleeding, arrhythmia and other serious complications, there is no unified standard.      The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical     chemoradiation curative effect and side effects, for rational use in the process of radiation     and chemotherapy megestrol provide guidelines. A total of 210 patients will be accrued from     China within 2 years.The primary endpoint is overall survival and the secondary endpoints     include gastrointestinal reaction body weight change, performance status, leucopenia and deep     venous thrombosis.   "
48989|NCT02644395|"     Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs     to prevent rejection after kidney transplantation. However, the efficacy of preventing     rejection comes at the cost of important side-effects. Among the most common side-effects is     hypertension. Hypertension after kidney transplantation is clinically relevant, because it     increases the risk of cardiovascular disease and is associated with increased graft loss and     recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood     and, therefore, the treatment is currently empiric. These and other investigators recently     showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the     kidney, namely the thiazide-sensitive sodium chloride cotransporter.      Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to calcium     channel blockers (CCBs) (currently usually the treatment of choice) for the treatment of     CNI-induced hypertension.      Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients     with CNI-induced hypertension.      Study design: Single-center, randomized cross-over trial.      Study population: Kidney transplant recipients with a good functioning allograft (eGFR > 30     ml/min) who are hypertensive (daytime systolic blood pressure > 140 mm Hg) and who do not     have proteinuria (< 1 g/day).      Intervention: Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if     needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to 10     mg once daily).      Main study parameters/endpoints: 24-hour blood pressure recording.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Both drugs have long been registered for the treatment of hypertension. The     side-effect profile of both drugs is considered to be equal. The burden of the study for the     patients are blood pressure measurements using 30-minute automated blood pressure measurement     and 24-hour ambulatory blood pressure measurement.   "
48990|NCT02644382|"     The overall goal of this study is to qualitatively assess the surgical decision-making     process from both the patient and physician perspective        1. Conduct short in-person interviews with young women prior to surgery        2. Conduct focus groups with breast cancer survivors about their surgical decision and          experience        3. Interview surgical oncologists, plastic surgeons, medical and radiation oncologists          about their experiences and how they communicate with breast cancer patients about local          therapy decisions   "
48991|NCT02644369|"     This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers     in patients with solid tumors during treatment with pembrolizumab and in relation to response     to treatment.      Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed     cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer     cells.   "
48992|NCT02644356|"     Palliative care represents one of the most rapidly expanding sectors of health care. Its     rapid growth has been accompanied by widespread needs for training of multidisciplinary     personnel to work with the unique set of health issues specific to its population of patients     - not only those at end-of-life, but also patients with long-term, incurable, chronic and     degenerative illnesses. This project will develop the first online continuing education     program for palliative care personnel in the evidence-based application of complementary     therapies, to enhance patient care and quality of life in the palliative care setting.   "
48993|NCT02644330|"     The purpose of this study is to evaluate the efficacy and safety of minimally invasive     transthoracic device closure of ventricular septal defect. This is a multi-center randomized     controlled trial. Because of the characteristics of this surgical clinical trials, surgeons,     ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care     unit nurses are all need to be informed. Therefore the results of this trial need to be     system evaluated through objective methods to reduce bias.   "
48994|NCT02644317|"     Flatfoot, one of the most common foot problems experienced by preschool-aged children,     characterized by the collapse of the foot's medial longitudinal arch. Children with motor     developmental delay often have flatfoot, according to clinical observation, and research     indicates that preschool age is the main stage of the medial longitudinal arch development     period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely     to cause gait problems while growing up. The lack of a stable foot structure to support and     maintain posture may lead to delayed motor development. Early training intervention and help     to balance stability is the main rehabilitation goal for motor developmental delayed     children. With understanding of the foot development of motor development delayed children,     proper intervention can be provided to improve the movement and stability of the lower limbs.     The possible deformation of the foot structure and resultant pain in the future can also be     prevented.   "
48995|NCT02644304|"     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged     women and affects approximately 5-12 % of the female population.      In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected     individuals must have two out of the following three criteria:        1. Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).        2. Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank          virilization, while chemical indicators include raised concentrations of total          testosterone and androstenedione , and elevated free androgen index.        3. Polycystic ovaries on sonographic examination, presence of 12 or more follicles in          either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3          and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic          criteria, the majority of women with PCOS can be diagnosed without the need of          laboratory examinations.      Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation. It     is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the     latter being the more potent of the two. It is a non-steroidal compound closely resembling     estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby     signaling a lack of circulating estrogens and inducing a change in the pulsatile release of     gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone     from the anterior pituitary and is often enough to set the cycle of events leading to     ovulation into motion.      Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective     prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg,     which could be increased, if needed, to twice a week. This medicine has slight dopamine     agonistic side effects, headache being the most common one. Treatment in the very beginning     should start with a partial dose (half a pill) at bedtime with a small amount of food. Low     incidence of side effects and its weekly dose has made Cabergoline a choice drug for     treatment of related diseases.   "
48996|NCT02644291|"     This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers that     include medulloblastoma and high grade glioma, that are no longing responding to standard     therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange flavored tablet.     It is already approved to treat parasitic infections. The purpose of this study is to     determine the safety and side effects for increasing doses of mebendazole, followed by the     treatment of an additional 12 patients at the best tolerated dose.   "
48997|NCT02644278|"     The purpose of this study is to evaluate the safety and tolerability of VX-984 administered     alone and in combination with pegylated liposomal doxorubicin (PLD), and to determine the     maximum tolerated dose (MTD) and preliminary evidence of efficacy of VX-984 in combination     with PLD in subjects with advanced solid tumors   "
49125|NCT02642614|"     The main objective of the current trial is to investigate safety, tolerability,     pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4     weeks in patients with COPD.   "
49006|NCT02644161|"     An 8-week, assessor-blind, randomized controlled trial will be conducted. A total of 138     patients with post-stroke depression (PSD) will be randomly assigned to the combination     acupuncture treatment (CAI) (n = 69) or least acupuncture stimulation (LAS) (n = 69) for 3     sessions per week for 8 weeks. Treatment outcomes will be measured using the 17-item Hamilton     Self-Rating Depression Scale (HAMD-17), the Montgomery-Asberg Depression Rating Scale     (MADRS), and Self-Rating Depression Scale (SDS) for depression symptoms; Barthel Index (BI)     for physical function, the Montreal Cognitive Assessment (MoCA) for cognitive performance.     The assessment will be performed at baseline and once monthly thereafter. The study will be     conducted in School of Chinese Medicine Clinics, Tung Wah Hospital, Kowloon Hospital.   "
49115|NCT02642744|"     This study will examine if the attending nurse model will enhance critical patient-centered     elements of care that will in turn improve patient education and shared decision-making,     medication adherence, stroke-related health literacy, and reduce early readmissions to     ultimately yield improved patient quality of life. Our primary objective is to determine     whether the attending nurse model of care improves stroke patients' health at 7 days, 30     days, and 90 days after hospital discharge as assessed through questionnaires.   "
48998|NCT02644265|"     Detecting preserved consciousness in brain-injured patients by traditional clinical means     requires presence of motor function. Otherwise, patients may be erroneously classified as     being in a vegetative state. In order to circumvent the need for motor function, paradigms     using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) have been     developed. According to a recent meta-analysis, 15% of patients with a clinical diagnosis of     vegetative state can follow commands by performing mental imaginary tasks, strongly     suggesting they are indeed conscious. This is of utmost importance for prognosis, treatment,     and resource allocation. However, consciousness paradigms are usually employed in     rehabilitation medicine. Therefore, opportunities to optimize patient outcome at an early     stage may be lost. As a novel approach, the CONsciousness in NEurocritical Care cohorT study     using fMRI and EEG (CONNECT-ME) will import the full range of consciousness paradigms into     neurocritical care. The investigators aim to assess patients with acute brain injury for     preserved consciousness by serial multimodal evaluations using active, passive and resting     state fMRI- and EEG-based paradigms. A prospective longitudinal database and a biobank for     genomic and metabolomic research will be established. This approach will add essential     clinical information, including detection of preserved consciousness in patients previously     thought of as unconscious. Due to its complexity, this project is divided into nine work     packages. Eventually, the investigators will have established a clinical service for the     systematic assessment of covert consciousness, as well as an interdisciplinary research group     dedicated to the neuronal mechanisms by which consciousness recovers after acute brain     injury.   "
48999|NCT02644252|"     There is a need for improving the effect of first-line chemotherapy for lung cancer patients,     preferably by using an approach with none or very few side effects.      In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement     on top of standard chemotherapy for patients with advanced non-small cell lung cancer.   "
49000|NCT02644239|"     The ketogenic diet is a non-pharmacological treatment prescribed especially for children and     indicated in most specialized centers for patients with refractory epilepsy. The composition     of the ketogenic diet is based on high-fat, low-carbohydrate, moderate protein content, and     the production of ketone bodies is the probable mechanism involved in the control of     seizures. The relationship between the treatment of the ketogenic diet and changes in     oxidative characteristics, physical and lipid are not well established. Some studies show a     significant increase in total cholesterol and triglycerides in children being treated with     ketogenic diet, but other studies have shown that changes in lipid profile in the long term     do not appear to be significant, beyond the influence of these changes on coronary heart     disease are unknown. The studies performed in the last two decades have shown that besides     the changes in the lipid profile, oxidative modification of lipoproteins are essential for     the initiation and progression of atherosclerosis and physical properties of lipoproteins     also appear to be involved in this process, suggesting that the particle size of     lipoproteins, through the analysis of subfractions can provide more details of the     cardiovascular risk. Thus, this projetct aims to compare the effects of the classical     ketogenic diet with the ketogenic diet modified with lower content of saturated fatty acids     and a higher content of monounsaturated and polyunsaturated, the oxidative changes of LDL,     lipidomic profile, the concentration of antioxidants in production inflammatory cytokines and     the subfractions of LDL and HDL in children and adolescents with refractory epilepsy, the     clinical effect on controlling epilepsy.   "
49001|NCT02644226|"     Desflurane is known to be the most pungent of the currently used volatile anesthetics. The     investigators tried to find out if desflurane increases the incidence of perioperative upper     airway complications in infants and children undergoing general anesthesia using supraglottic     airways compared to sevoflurane.   "
49002|NCT02644213|"     The aim of the research is to evaluate the influence of physical and cognitive load as     pre-mission activity on the soldier`s physical and cognitive performance, in compare to     physical load alone.      In order to do so, 12 healthy subjects will perform stimulated road march using a virtual     reality environment combined with cognitive load and without, and their physical and     cognitive performance will be evaluated by tests before and after.   "
49003|NCT02644200|"     Oral rehydration therapy is the only treatment recommended by the World Health Organization     in acute diarrhea in children. The aim of this study was to compare the efficacy and safety     of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in     children with acute gastroenteritis.      This is a single-blind, prospective, randomized and parallel study performed in two Pediatric     Services of tertiary referral hospitals. Patients, ages 3 to 36 months with acute     gastroenteritis randomized to receive an oral rehydration solution (OR), or an oral     rehydration solution plus gelatin tannate (OR+G). The primary outcomes evaluated were: the     number of bowel movements after 48 and 72 hours after initiating treatments. Secondary     outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other     clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two     treatments were also recorded.   "
49004|NCT02644187|"     This pilot study will try to minimize the pain during exposure to a new red light source     (RhodoLED®, Biofrontera Bioscience GmbH, Leverkusen, Germany) used for PDT without     compromising its effect on AKs.      The study design will have an open and prospective, two-armed, split-face design.     Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks, torso,     back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose is to     investigate if a modified irradiation protocol can lower the pain while having the same     effect on AK clearance rates as compared to the standard PDT irradiation protocol.      Before any study-related procedures are performed, the participants will be thoroughly     informed about the study and will be given the opportunity to ask questions. The participants     will thereafter sign and date the informed consent form. This constitutes as visit 0.      On visit 1, a randomization to either the standard or the modified irradiation protocol will     be performed on one side of the face/body and the other irradiation protocol will then be     applied on the other side of the face/body. The participants should have AKs on two     comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be     randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the     other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo, Norway),     which is the traditional lamp used at our department as mentioned above.      The treatment will be given at visit 1. During the treatment, the participants will be asked     continuously, every third minute, to estimate the pain on each treatment side using the     visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the     end of the treatment, the participants will also be asked to summarize the treatment as a     whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form     with questions regarding adverse effects (AEs) during the hours and days after the treatment.     The efficacy of the treatment will also be assessed at a follow-up (FU) visit, visit 2. The     investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation     protocol should be at least as good as the standard irradiation protocol. The randomization     is blinded for the investigator at the FU visit to minimize the possibility of favoring one     irradiation protocol.   "
49007|NCT02644148|"     The current commonly used for distal gastri cancer in gastrointestinal anastomosis is     Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which     involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the     result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic     uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the     continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our     centre. Our previous results showed that this operation had a low postoperative complication     and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe     procedure. However, some limitations are noticed. The report from South Korea is a     retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to     perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to     improve QOL of patients after laparoscopic distal gastrectomy.   "
49008|NCT02644135|"     This is a pilot study of the safety, tolerability, and effectiveness of Halo to prevent acute     upper respiratory illness and respiratory virus infections. This study will be conducted at     one site (University Hospitals Case Medical Center) in healthy adults during the upcoming     respiratory virus season (12/15/11 to 3/14/12). The intervention will be with Halo, a     commercial product which is FDA-approved for the treatment of xerostomia. The placebo will     consist of the phosphate buffered saline plus the preservatives in the Halo formulation and     without CPC - the active antiseptic. This placebo was chosen as the Halo formulation without     CPC serves to act as a barrier to attachment of oral pathogens, and as such is an important     contributing factor to its antimicrobial activity (see above). Also, the formulation without     CPC with preservatives exhibits some antibacterial and antiviral activity. Moreover, the     formulation without CPC and no preservatives is easily contaminated and not practical to     utilize as the placebo in these studies.      Male and female participants 18-45 years of age will be recruited and monitored for the     development of, duration, and severity of clinical symptoms and signs consistent with acute     respiratory disease (defined below) captured daily through diaries, and PCR confirmation of     important respiratory viruses including influenza, rhinoviruses, adenoviruses, and     respiratory syncytial virus during episodes of acute respiratory disease during the length of     the study will be undertaken. Secondary objectives will assess the tolerance, acceptability     and adherence to Halo as well as the change in the bacterial (oral streptococci and Group A     streptococcus) and fungal microflora in the oropharynx. School or work absenteeism, visits to     physicians' offices, emergency departments and urgent care centers will also be captured.     Conventional cultures for these bacterial and fungal organisms will be pursued (see below).     Throughout the study period, the safety, tolerability, acceptability and adherence to study     products will be assessed.   "
49009|NCT02644122|"     The purpose of this study is to test the good and bad effects of an experimental drug called     SF1126. This drug is being tested in patients whose cancer has not been controlled by     available standard therapies and who have certain genes in their tumor.      SF1126 is a drug that inhibits a cell protein called phosphatidyl inositol 3 kinase (PI3K).     PI3K is part of signaling pathway that tells cancer cells to grow, survive, invade and     metastasize. PI3K also has an important role in the development of blood vessels that are     required to support tumor growth. SF1126 is being developed by SignalRx Pharmaceuticals, Inc.     It is considered an experimental drug because it is not approved by the FDA for any disease     treatment.   "
49010|NCT02644109|"     Hypercholesterolemia is an important risk factor for cardiovascular disease, asociated     primarily with high plasma levels of LDL lipoprotein, which in turn depend on the endogenous     hepatic synthesis of cholesterol and its absorption at intestinal level. It has been     demonstrated that there reducing plasma LDL is beneficial, mainly with the use of statins,     which are the first treatment option for a moderate hypercholesterolemia.      Phytosterols reduce the intestinal absorption of cholesterol by reducing its incorporation     into lipid micelles. Consequently, phytosterols have become a relevant alternative treatment     against low hypercholesterolemia. The target population are 40 to 65 years old individuals     with low hypercholesterolemia.   "
49011|NCT02644096|"     Objective: The investigators hypothesized that all areas of health status after total hip     replacement could be improved in patients aged over 65 years and over by using telephone     support and counselling 2 and 10 weeks after surgery compared with a control group receiving     conventional care and treatment.      Design: A randomised clinical trial focusing on patients' health status by using SF-36 at 4     weeks pre- and 3 and 9 months postoperatively was carried out. Sample: 180 patients aged 65     and over were randomised 4 weeks preoperatively to either control or intervention groups.     Measurements: Both groups received conventional surgical treatment, but the intervention     group was interviewed by telephone 2 and 10 weeks after surgery. Patients were given     counselling within eight main dimensions with reference to their postoperative situation.      Key-words: THR - elderly patients - health status - postoperative support - counselling   "
49012|NCT02644083|"     The primary objective of this study is to test the hypothesis that DMF can improve     mitochondrial function in the brain of people with MS. The investigators will assess     mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic     resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.   "
49020|NCT02643979|"     Propofol is one of the most popular anesthetic drugs used for sedation during upper     gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing     patients to leave the hospital sooner. However, when administered it can also slow the     breathing of patients and cause others to have upper airway obstruction (such as snoring)     which can impede proper spontaneous breathing. Ketamine is an agent that is capable of     providing both pain control and sedation while having either minimal effect on breathing or     promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce     the total amount of Propofol used resulting in a procedure being performed under the same     level of sedation but without the downside of reduced spontaneous breathing. Patients who are     obese (defined as body mass index greater than 35) tend to be even more susceptible to this     effect of Propofol. The researchers are investigating whether the addition of Ketamine will     indeed allow for this continued comfortable level of sedation while promoting continued     spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.   "
49037|NCT02643758|"     The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low     addition and nasally decentered optical zone are effective in controlling myopic progression     in children. Visual manipulations induced by multifocal soft CLs with high addition have been     shown to inhibit eye growth and myopia development in children by recent studies. Several     theories have been proposed including alteration in peripheral defocus, reduced accommodation     demand, alterations in binocular vision status and increased ocular higher order aberrations.     However, those theories remain to be proven and the optical properties and performance of     multifocal soft CLs have not been investigated in children.   "
49013|NCT02644070|"     The primary aim of the present multicenter randomized controlled trial was to evaluate and     compare the shortterm clinical and histological changes of extraction sockets after ridge     preservation procedures with changes of extraction sockets that healed naturally.      The secondary aim was to evaluate which, if any extraction socket characteristics could have     affected tissue changes occurring at the augmented as well as naturally healed sites.      Recruitment and enrollment of patients were performed from June 2011 to June 2012 in five     university centers/private practice:        -  University of Pisa;        -  University of Murcia;        -  University of Ancona;        -  Private practice, Dr. Di Felice;        -  University of Verona.      Randomization:        1. extraction sockets with spontaneous healing;        2. extraction sockets grafted with pre-hydrated collagenated cortico-cancellous porcine          bone, with a particle size between 600 and 1000 μm;        3. extraction sockets grafted with cortical porcine bone, with a particle size between 600          and 1000 μm.      Outcome Variables        -  Complications        -  Changes of ridge volume contour;        -  Vertical bone changes;        -  Buccal-Lingual Width;        -  Histomorphometric parameters.      Sample size was calculated comparing outcome data between grafted sockets versus non-grafted     sockets. The primary parameter was the change in mid-buccal vertical height (0.7±1.4mm and     3.6±1.5mm, respectively, for the test and control groups) (Barone et al. 2008). Final sample     size was increased to 30 subjects per group due to possible patient dropout events. Each     center contributed according to the predetermined 1:1:1 ratio; the fresh extraction socket     was considered the unit of randomization.      Corrections for balancing the three experimental groups for confounding factors were not     applied.      A matrix elaborator performed all the analyses§§: multi-way analysis of variance (ANOVAn) was     applied, then appropriate post hoc comparison tests were run; post hoc estimated effect sizes     were calculated with a power of 0.9. The level of statistical significance was set at 0.05     for all analyses.   "
49014|NCT02644057|"     Heart failure is recognized as one of the most common indications for hospitalization amongst     adults aged >65 years in United States with estimated Medicare cost to be 17 billion or more.     Chronic heart failure is one of the most life threatening cardiovascular disorder thought to     affect nearly six million US population with 600,000 new cases every year. The heart is     responsible for perfusion to all vital organs including kidneys and dysfunction in either     affects both the vital organs. When dysfunction of heart leads to dysfunction of kidneys or     vice versa it is referred to as cardio renal syndrome (CRS). The underlying pathophysiology     for CRS has been poorly understood and considered multifactorial. Worsening renal function     defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of     patients with ADHF and is associated with greater length of hospital stay, hospital     readmission and death. A number of interventions have been used including giving diuretics     which helps in decongestion and helps the heart pump blood more effectively. Sometimes these     therapies are not effective and may even lead to worsening of renal function. In such cases ,     inotrope agents which increase the contractility of the heart have been used to help pump     more blood to vital organs. There have been very few trials assessing the efficacy of these     agents for improving kidney function .The investigators aim to assess the renal recovery with     two such agents - dobutamine and milrinone in patients with cardiorenal syndrome who are     coming with acute decompensated heart failure   "
49015|NCT02644044|"     Multiple sclerosis (MS) is characterized pathologically by demyelination, axonal loss, and     glial scar formation. Clinically, most patients have a relapsing-remitting course of MS     (RRMS) that over time may become progressive without remissions - a secondary progressive MS     (SPMS). About 15% of patients have a progressive course from onset which is called primary     progressive (PP).      Currently, there is no approved treatment for PPMS and for SPMS only therapy with     mitoxantrone showed mild effect. Thus, more effective therapies need to be developed for     treatment of SPMS and PPMS.      Methotrexate (MTX), an anti-metabolite, has been in clinical use since 1948 when it was found     to produce temporary remission of acute childhood leukemia.      There are accumulating evidences that in progressive MS patients there are follicular     lymphoid structures in the meninges and in the Virchow-Robin spaces. Therefore, intrathecal     therapy may target the pathological follicular lymphoid activity.      The safety of intrathecal MTX (ITMTX) has been demonstrated by its widespread use in treating     lymphoproliferative diseases and leptomeningeal metastases. Sadik et. Al. reported about the     feasibility and safety of using intrathecal methotrexate (ITMTX) as a treatment for     unresponsive patients with progressive forms of MS. In their open label study they found that     ITMTX may have a beneficial effect in progressive forms of MS and that it was well tolerated     with no serious adverse events.      The investigators aim is to evaluate the efficacy , safety and tolerability of intrathecal     methotrexate administration every 3 months in progressive 30 patients with progressive MS.     The investigators will evaluate clinical, laboratory evaluation of the blood and     cerebrospinal fluid as well as the MRI scans of the participants. Each patient will be     treated 4 times for 1 year with the option to continue for another 1 more year with the same     protocol.   "
49016|NCT02644031|"     Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are     routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a     complicated multi factorial process and is affected by factors related to patients, to the     tooth and to the skills and experience of the dentist and because of that, if the     interrelation of these factors is not considered in a PP, study data might be confusing. Any     study trying to evaluate the effect of a specific technique or new device in the incidence or     characteristics of PP should control all the confounding factors that have been described to     be involved in the tested outcome.      reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations are     because of the differences in study methods, and treatment procedures after root canal     treatment, selection of patients or experience and skills of the dentists, vary when     different studies are compared.      Many studies had confirmed that chemomechanical debridement of the root canal results in     extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and     root canal irrigants through the apical foramen. All preparation techniques and instruments,     regardless of maintaining shorter working length of the apical terminus have reported to be     related with extrusion of infected debris, and some of them extruded less material and others     extruded more.      Periapical inflammation and postoperative flare-ups may result from apical extrusion of     debris that is also referred to as the worm of necrotic debris A common outcome of the     studies examining the amount of apically extruded debris was that the techniques involving a     push-pull filing motion usually produce a greater mass of apical debris than those have     rotational action Files which has reciprocating and in-and-out filing motion, may act as a     piston, extruding more debris and irrigants. While the file with continuous rotation motion     like a screw conveyor improving transportation of dentinal chips and debris coronally.      In this study, investigators compare post-endodontic pain between these two systems. Mtwo (     continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of     this study is Evaluation of post-endodontic pain after root canal treatment with two rotary     systems: Mtwo & safe-sider   "
49017|NCT02644018|"     The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective     and safe in the treatment of influenza and other acute respiratory viral infections in the     course of standard therapy in 3-6 years old patients.   "
49018|NCT02644005|"     Prospective, bicentric observational study to assess a novel system for automated control of     mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.   "
49019|NCT02643992|"     Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging.     The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC     concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be     sufficient for all patients.      Objectives: To investigate the factors associated with per-procedural [DOAC]. To test the     hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal     perprocedural [DOAC], defined as [DOAC] < 30 ng/mL.      Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in     this multicentre, prospective, observational study. [DOAC], will be measured during invasive     procedure.   "
49021|NCT02643966|"     The purpose of this study is to evaluate the role of technologist-performed whole breast     ultrasound for detecting breast cancer in the screening population of women with dense     breasts.   "
49022|NCT02643953|"     Background: Nigeria has the second highest absolute number of maternal deaths and perinatal     deaths in the world. The country contributes 14% of all maternal deaths worldwide, second     only to India. Although all parts of the country are affected, most maternal, and perinatal     deaths occur in the northeast and northwest geo-political zones, where women have limited     access to evidence-based maternal and newborn health services. Affected women and families     are mainly those who have little or no formal education, who are poor and marginalized, and     who live in rural and sub-urban communities.      Problem: Research carried out in various regions of Nigeria has shown that insufficient     access to pregnancy health services is a major factor that places women at high risk of     adverse maternal and perinatal outcomes. Maternal care provided within Nigeria's numerous     local Primary Health Centres (PHCs) is an efficient and practical avenue for reaching     vulnerable women and their newborn infants, and PHC use is strongly encouraged by the     Nigerian Federal Ministry of Health.      Research Question and Objective: The key research question and objectives are as follows: 1)     To determine the main factors that prevent vulnerable women from using PHCs or receiving     maternal and neonatal care therein; 2) To identify effective community level interventions     for improving women's access to maternal health services, as a means to reduce maternal and     perinatal morbidity and mortality in Nigeria.      Methodology: This study will complete a community-based, multi-site project using a mixed     methods approach. The project will be done in three sequential phases: A data gathering phase     (Phase 1), an intervention phase (Phase 2), and the implementation of the findings (Phase 3).     The study will be conducted over 54-months in six communities, and another six communities of     similar status will serve as control sites. During Phases 1-3, surveys about maternal health     services utilization will be carried out at baseline, midterm and completion points of the     project.      Potential Impact: Increasing women's access to evidence-based maternity care is likely a     direct way to reduce maternal and neonatal mortality in Nigeria. The proposed project will     determine how we can effectively increase access to PHCs, and then bring those findings into     a policy and program format that can be applied across the country.   "
49023|NCT02643940|"     This study will be recording pressure wire readings from both blocked and narrowed arteries,     to better guide treatment options; medications, stents or potentially bypass surgery, for     patients with Chronic Total Occlusion (CTO).   "
49024|NCT02643927|"     The aim of this study was to assess and compare the efficacy of a standard 8-weeks protocol     based on the Mindfulness Based Stress Reduction MBSR program versus a 4-week shortened     version of the protocol in the improvement of wellbeing variables in a non-clinical     population in Spain. The investigators initial hypothesis was that both protocols are     efficacious but the standard 8-week performs better that the short one.   "
49025|NCT02643914|"     Nicotine is the most common drug of abuse in the United States, and has addiction strength     comparable to cocaine, heroin, and alcohol. It is the primary addictive component of tobacco,     and its use markedly increases risk for cancer, heart disease, asthma, miscarriage, and     infant mortality. Addiction is thought to be caused primarily by the intersection of two     components: 1) the impact of drug pharmacokinetics on the dynamics of dopamine response, and     2) dysregulation of the brain's reward circuit. While the term 'dysregulated' tends to be     used qualitatively within the neuroscience literature, regulation has a precise and testable     meaning in control systems engineering, which has yet to be addressed in a quantitative     manner by current neuroimaging methods or models of addiction. Current approaches to     neuroimaging have primarily focused on identifying nodes and causal connections within the     meso-circuit of interest, but have yet to take the next step in treating these nodes and     connection as a self-interacting dynamical system evolving over time. Such an approach is     critical for improving our understanding, and therefore prediction, of trajectories for     addiction as well as recovery.   "
49026|NCT02643901|"     This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD)     of single subcutaneous (SC) injection of GW003 in healthy subjects.   "
49027|NCT02643888|"     The main task of this study includes analyses of the BCR-ABL1 (breakpoint cluster     region/Abelson) gene and mutations in the BCR-ABL1 tyrosine kinase domain within flow-sorted     stem cells from the bone marrow and/or peripheral blood specimens. To assess the germline     configuration of the patient, DNA from fingernail clippings will be investigated.   "
49028|NCT02643875|"     Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas     permeable contact lens exerting positive pressure on the central cornea to temporary reduce     refractive error. The investigators have shown that this treatment is effective for myopic     control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses     in the market are fitted based on the Jessen formula. The compression factor was introduced     to compensate for regression of the ortho-k effect during the no lens-wear period, so that     the wearer can obtain clear distance vision throughout the day and most lens designs use a     compression factor of 0.50-0.75D. However, in a retrospective study (mixed brands of ortho-k     lenses), showed that most patients did not achieve an over-correction of 0.75D. In order to     achieve an over-correction of 0.75D, an extra flattening power of about 1.50D instead of     0.75D should be be targeted. The increased compression factor is expected to increase the     target reduction and it may play a role in myopic control and providing a higher successful     rate in fitting ortho-k lenses.   "
49029|NCT02643862|"     This is a pilot randomized, double-blind, placebo controlled study which will be conducted at     a single center. All participants will receive oral immunotherapy for their specific food     allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36     participants will receive Xolair for 16 weeks while 12 will receive corresponding placebo     instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair.   "
49030|NCT02643849|"     The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract     symptoms in subjects to achieve bladder drainage in men unfit for other treatments.   "
49031|NCT02643836|"     The objectives are to evaluate impact of Pulsed electromagnetic field (PEMF) therapy on     patients with Post-Concussive Syndrome with Rivermead Post Concussion Symptom Questionnaire     (RPQ) as a primary outcome, followed by fatigue and mood as second and tertiary outcomes     respectively. The investigators will also investigate brain tissue activity and oxygenation     by evaluating brain wave activity via non-invasive quantitative electroencephalogram and near     infrared spectroscopy testing pre and post study to better understand the metabolic effect of     the PEMF intervention.      The investigators hypothesize that the PEMF treatment will have an effect on improvement of     brain metabolism as measured by Near Infrared Spectroscopy which will in turn assist with     improvement of the chronic symptoms of cognitive deficits, mood and fatigue as related to     Post-Concussive Syndrome.   "
49032|NCT02643823|"     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord     mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.   "
49033|NCT02643810|"     In this controlled trial, patients with tetralogy of Fallot will be randomized to either     interval training, continuous training, or usual care groups.   "
49126|NCT02642601|"     the aim of the study is to assess the role of indomethacin in cases of difficult embryo     transfer in intracytoplasmic sperm injection cycles.   "
49038|NCT02643745|"     Acute kidney injury (AKI) is a frequent complication after cardiac surgery. Its incidence     ranges from 19 to 44% depending on the study and which definition is used: Acute Kidney     Injury Network (AKIN) classification or RIFLE criteria (Risk, Injury, Failure, Loss,     End-Stage Kidney Disease) based on serum creatinine and urine output.      AKI is associated with increased mortality, more complications, a longer stay in the     intensive care unit and hospital, and increased health care costs. Moreover, the patients who     require renal replacement therapy (RRT) have the highest mortality and complications1.The     mortality risk in patients developing acute renal dysfunction after cardiac surgery increases     by approximately 40%, while the overall mortality rate after cardiac surgery ranges between     2% and 8%.      There are some well-known risk factors associated with AKI, including baseline patient     characteristics (age and comorbidities), need of perioperative blood transfusion or presence     of previous chronic kidney disease. The main objective of this study is to evaluate if a     nephrologist management and control of potential risk factors of renal disease can be used to     prevent AKI, thereby minimizing the risk of need RRT, reducing costs and improving survival     in this patients.   "
49039|NCT02643732|"     This is a small randomised-controlled trial (RCT) using methylphenidate as a treatment for     clinically-significant fatigue in sarcoidosis patients with stable disease. The primary     outcomes are feasibility, aimed at determining factors that will influence the design a     future, larger RCT, which will be powered to look at clinical efficacy of the intervention.   "
49040|NCT02643719|"     Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment     for migraine in the Emergency Department (ED) and prescribing migraine preventive medications     in the ED. The study will examine the effect of these treatments, both individually and in     combination, on pain severity and headache-related disability. This study is designed to     examine the feasibility of comparing four interventions for ED patients presenting with     migraine. Group 1: Starting topiramate; Group 2: Doing a brief behavioral intervention; Group     3: Treating with combination therapy of topiramate and behavioral intervention; and Group 4:     Standard of Care.   "
49041|NCT02643706|"     The purpose of this clinical trial is to investigate the relationship between the gene     polymorphism of aldehyde dehydrogenase 2 and contrast induced nephropathy and its mechanism.   "
49042|NCT02643693|"     This study will provide an initial assessment of the acceptability of the Nicotine Lactate     Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC)     smokers to use P3L to maintain their customary nicotine intake.      The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will     be evaluated as well as the safety and tolerability of the P3L.   "
49043|NCT02643680|"     1. The wound healing time of STSG donor sites which are treated with the novel biocellulose          wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.        2. The wound quality of STSG donor sites which are treated with the novel biocellulose          wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.        3. The amounts of STSG donor site infection which are treated with the novel biocellulose          wound dressing containing silk sericin and PHMB should not be more than Bactigras®.        4. The pain level of STSG donor sites which are treated with the novel biocellulose wound          dressing containing silk sericin and PHMB should be less or equal to Bactigras®.        5. Adverse events which are occurred from the novel biocellulose wound dressing containing          silk sericin and PHMB treatment for STSG donor sites and Bactigras® will be reported, if          they occur.   "
49044|NCT02643667|"     Multicenter phase 1/2 study of neoadjuvant Ibrutinib in men with localized prostate cancer     undergoing RP as their initial locally directed therapy with curative intent. To assess the     immune response following neoadjuvant treatment, tissue from RP specimen will be compared to     tissue from core biopsy specimen obtained prior to treatment, with each subject serving as     his own control. Immune infiltration will also be compared to a reference cohort of 12     patients who had undergone RP, matched to the study population using the UCSF CAPRA-S score.   "
49045|NCT02643654|"     Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Although adalimumab is     recently licensed for moderate to severe HS, many cases fail to respond or relapse during     treatment. Favorable outcomes from a recently conducted double-blind randomized clinical     study on the efficacy of anakinra, one interleukin(IL)-1alpha blocker, in hidradenitis     suppurativa (HS), led to validate the efficacy of MABp1, a true human antiIL-1α antibody in     these cases.   "
49046|NCT02643641|"     BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different     recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This     prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of     allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass     pollen season.   "
49047|NCT02643628|"     This is an open-label, randomized, multicenter, prospective trial assessing the efficacy and     safety of microneedling treatment alone vs. microneedling treatment followed by treatment     with Bellafill for correction of distensible atrophic facial acne scars.   "
49073|NCT02643290|"     Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis     Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic     pain secondary to scoliosis.      20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. The sample size     was calculated considering the data collected during the development of the brace in the US.     Patients will be evaluated at baseline immediately before starting with the brace and after 4     weeks and 6 months. The brace must be worn for at least 2-4 hours per day.      At each evaluation they will be asked to fill the questionnaires, to be used as outcome     measure of the results.   "
49103|NCT02642900|"     Candida albicans is the most prevalent species in denture-related stomatitis (DS). There are     several treatment options for this condition, including the use of antifungal agents such as     nystatin and miconazole. The side effects and the increasing number of resistant species     caused by the use of these drugs encourage the development of alternative therapies.     Photodynamic Therapy (PDT) has been used as a promising treatment of stomatitis. In this     randomized clinical trial, the effectiveness of PDT was evaluated. Patients in this study     were allocated to two groups. One group was treated with nystatin, and the other group was     treated with PDT.   "
49048|NCT02643615|"     Post-operative visual loss (POVL) following non-ocular surgical procedures is an infrequent     but severe complication. Little is understood about this complication, but most cases seem to     result from loss of blood flow to the optic nerve. This is a pilot, single center,     prospective, randomized, two-arm study involving 20 subjects at The Ohio State University     Wexner Medical Center who are scheduled to undergo spine surgery that requires prone position     and at least two hours of general anesthesia or total intravenous anesthesia (TIVA) and     intraoperative neurophysiological monitoring. Patients will be randomized to either general     anesthesia or TIVA, and wear the SightSaver device to monitor visual evoked potentials (VEPs)     during surgery in order to detect possible changes in optic nerve function that may lead to     POVL. We hypothesize that this new, flexible, disposable device will yield better results and     more patient satisfaction than devices currently used for visual monitoring during prone     spine surgeries.   "
49049|NCT02643602|"     Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired     acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in     the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is     administered to the patients especially in patients with already existing renal impairment.     Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium     chloride alone. The combination of the two prophylaxis has not been investigated yet.      Aim of this prospective randomized trial is to investigate the effect of hydration with     sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all     patients receive.   "
49050|NCT02643589|"     The purpose of this study is to compare the incidences of GVHD in haploidentical     hematopoietic stem cell transplant recipients receiving different dose of antithymocyte     globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators'     first objective was to investigate the optimal dose of ATG for aGVHD.   "
49051|NCT02643576|"     This highly innovative experimental trial is designed to examine the independent and joint     effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary     calories and offering an incentive to encourage the purchase of more healthful foods.   "
49052|NCT02643563|"     Severe pain following shoulder surgery is common and remains a major challenge. The     interscalene nerve block is well suited for operations on the shoulder or upper arm, for     providing surgical anesthesia as well as prolonged effective postoperative analgesia.      Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local     anesthetic. The current trend is to lower the volume of local anesthetic for     ultrasound-guided interscalene block in order to reduce potential complications such as     phrenic nerve paralysis and local anesthetic toxicity. However, at low volumes the analgesic     duration of the block could be compromised. Studies to elucidate the best local anesthetic     agent, concentration and adjuncts to prolong analgesia at low volumes are needed. Ropivacaine     and Bupivacaine are long acting local anesthetics commonly used for peripheral nerve blocks,     however, there are no studies comparing their analgesic duration in the setting of low volume     interscalene block to date.      This study will investigate the analgesic duration of 0.5% Ropivacaine versus 0.5%     Bupivacaine with 1:200,000 epinephrine versus 1% Ropivacaine for low volume US-ISB.      This study aims to conduct a comparison of the duration of post operative analgesia achieved     by these agents, hence allowing the appropriate local anesthetic agent and concentration     selection in low-volume techniques.   "
49053|NCT02643550|"     The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses     of IPH2201 given IV in combination with cetuximab in patients who have received prior     systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and     neck (SCCHN). A cohort expansion will evaluate antitumor activity of the combination.   "
49054|NCT02643537|"     The aim of this study was to evaluate the clinical outcome of this rare injury with special     emphasis on associated pathologies. Additionally, we aimed to develop an algorithm for the     diagnosis of associated pathologies following LEH.   "
49055|NCT02643524|"     The purpose of the study is to determine if patients wearing a CAM walker boot have a change     in weight compared to patients who wear a CAM boot and are provided nutritional and upper     body exercise information.   "
49056|NCT02643511|"     Whole gland LDR brachytherapy has been a well established modality of treating low risk     prostate cancer. Treatment in a focal manner has the advantages of reduced toxicity to     surrounding organs.      AIM: To determine the utility of focal LDR brachytherapy in form of hemiablative treatment     for localized prostate cancer demonstrating the feasibility of the delivery of the     prescription dose to the half of the prostate in terms of meeting standard dosimetric     parameters while respecting same or lower tolerance doses of adjacent normal organs.      To determine acute and late rectal, urinary and sexual toxicity after this procedure.      To assess the change from baseline in QOL indicators at specific time intervals using     validated international questionnaires [International Prostate Symptom Score ( IPSS),     International Index of Erectile Function ( IIEF ), Expanded Prostate Cancer Index (EPIC)]     after this treatment.      To evaluate the local tumour control in terms of biopsy outcomes after focal brachytherapy 36     months after the treatment.      To compare target coverage and relative doses to the rectum and the urethra for the same     patient performing a hemigland treatment planning vs Whole gland treatment planning.      STUDY DESIGN: Multi-institution prospective trial to determine whether hemiablative treatment     with LDR for prostate cancer is dosimetrically safe and feasible.This study will record data     for 20 patients with ipsilateral with low and low tier intermediate risk disease.The study     will record quality of life parameters in particular in terms of urinary, rectal and sexual     function side effects.      INTERVENTION:        -  Baseline Transperineal Template guided mapping prostate biopsy with >20 cores (not          required if already performed)        -  Multiparametric MRI within the 3 months prior to registration and at 18 & 36 months.        -  Hemigland prostate region will be targeted with the prescription dose and receive 144 Gy          of Iodine125 (I125).        -  The quality of life assessment will focus on erectile function, urinary function, bowel          function, and general health related quality of life        -  Postimplant CT Planning day 30 after the implant for quality assurance.      MEASUREMENT OF ENDPOINTS :      Dosimetric parameters record, Toxicity and QOL evaluation forms, PSA follow up and biopsies     at 36 months to assess local control.   "
49057|NCT02643498|"     The purpose of this study is to find out the maximum dose of SBRT that can be safely given     after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.   "
49058|NCT02643485|"     Static pedobarography is routinely used for pre- and postoperative questions regarding     plantar foot pressure. This Investigation does insufficiently detect dynamic Forces. Hence,     dynamic pedobarography might give some important insights in detecting plantar foot pressure     after forefoot reconstruction.   "
49087|NCT02643108|"     Primiparae with a live singleton pregnancy in cephalic presentation past 34 gestational weeks     will be randomized to lateral episiotomy or no episiotomy when operative vaginal delivery is     indicated. Primary outcome is obstetric anal sphincter injury (OASIS) of any degree.   "
49059|NCT02643472|"     BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU)     care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be     classified as children with special health care needs (CSHCN) who will require health and     related services of a type or amount beyond that required by children generally. NICU parents     report increased anxiety and stress during their stay and transition home from the NICU.     Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and     depression for mothers, however, no studies have evaluated the effects of long term     post-discharge peer support. Children's National (CN) provides medical home services to CSHCN     through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who     provide peer emotional support, access to community resources, and assistance with navigating     complicated health systems. NICU graduates and their caregivers may benefit from support     provided by PNs after discharge. No data regarding the impact of PNs on patient and family     outcomes of the NICU graduate are available.      OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety,     depression; infant health care utilization, and immunization status.      METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months     (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and     12 months after discharge will be collected from caregivers in both groups including scales     for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and     immunization status. Outcomes will be compared at 12 months.      PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety,     and depression; infant health care utilization and immunization status.      ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in     the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support     after discharge, when a family is faced with the total care of their child without structured     supports, can significantly impact parents' ability to care for their child. The     investigators anticipate that this simple intervention will increase self-efficacy in     caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health     outcomes for their child.   "
49060|NCT02643459|"     Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms     is supplemented with a prognostic biomarker?   "
49061|NCT02643446|"     The Purpose of this study is to assess the seroconversion using inactivated poliovirus     vaccine (IPV) and oral poliovirus vaccine (OPV) sequential schedule in pilot areas where IPV     was phased introduced into national immunization program (NIP) in China.   "
49062|NCT02643433|"     Japanese encephalitis (JE) is the leading cause of viral neurological disease and disability     in Asia. A live attenuated vaccine (LJEV) manufactured in China has several advantages over     other JE vaccines such as one dose schedule, using for infants, and the cheaper cost. Because     the LJEV has been prequalified by the World Health Organization (WHO) in 2013, it will likely     be used in other countries, and possibly co-administered with the first dose of     measles-containing vaccine (MCV) to ensure early protection and reduce additional vaccination     visits.      The evidence for immunogenicity and safety of co-administration of LJEV with MCV is limited.     Only one study conducted in the Philippines examining the co-administration of MCV with LJEV     among 9 months infants, the results showed the proportion of achieved sero-protection against     measles following MCV (96%) was slightly lower than in the MCV-only group (100%), and the     measles antibody titres were also slightly lower in the co-administration group. Due to     limited evidence available, the WHO position paper of measles vaccines has encouraged further     investigation on the possible impact of co-administration of LJEV on measles vaccine     effectiveness.      In China, Measles-Rubella combined vaccine (MR) and LJEV is given at 8 months of age     nationally. Considering China is reaching towards the goal of measles elimination, it will be     important to conduct a study to compare the immunogenicity of MR administered alone or with     LJEV, and also evaluate the safety and tolerability of LJEV administered with MR among 8     months infants.      This study is a prospective, randomized, open-label, multi-center study enrolling infants     aged 8 months. Basic demographic information of the infant will be taken and blood samples     will be collected at enrollment (baseline) and at 6weeks following administration of MR, the     measles antibodies will be measured, and compare seroconversion rates to assess for     non-inferiority. All infants will be monitored for adverse events after MR.   "
49063|NCT02643420|"     The purpose of this study is to compare the efficacy of a single dose of SPI-2012 with     pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in patients with     early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the     Duration of Severe Neutropenia (DSN) in Cycle 1.   "
49064|NCT02643407|"     To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin     in managment of advanced/relapsed squamous cell lung cancer.   "
49065|NCT02643394|"     The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the     management of postoperative pain is understudied and largely unknown. In this observer     blinded randomized clinical trial, investigators aim to determine the comparative efficacy of     PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.   "
49066|NCT02643381|"     Patients who are having problems breathing sometimes require placement of a breathing tube in     their mouth and windpipe. The purpose of this breathing tube is to save the patient's life.     It is common to give the patient a medication to sedate him or her before the breathing tube     is placed. For patients who are gravely ill two medications are commonly used: etomidate or     ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical     Center and Parkland Memorial Hospital would like to do a study to figure out which one is     better for our patients.   "
49067|NCT02643368|"     This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along     with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval     between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the     first dose of mOPV2, in a two dose schedule with a four week interval, is administered     simultaneously with IPV.   "
49068|NCT02643355|"     Withdrawal from opioids is a clinical scenario that emergency department physicians encounter     frequently. Patients who present with opioid withdrawal display symptoms such as agitation,     anxiety, myalgias, abdominal pain, diarrhea, nausea, and vomiting. Currently, the standard     treatment for opioid withdrawal is clonidine (an alpha-2 adrenergic agonist), as well as     supportive cares (anti-emetics, intravenous fluids). Olanzapine is an atypical antipsychotic     that is given frequently in the ED for many of the same symptoms that are seen in patients     who are experiencing opioid withdrawal, however its use in this toxidrome has never been     studied. The hypothesis of this study is that olanzapine is a safe and efficacious option     when compared to clonidine for the treatment of opioid withdrawal in the emergency     department.   "
49069|NCT02643342|"     This is a two-year longitudinal study investigating the optical and structural effects of     increased compression factor of orthokeratology lens on eyes and the corresponding effect on     change in choroidal thickness and therefore myopic control.   "
49070|NCT02643329|"     The purpose of the study is to compare the bioavailability of a generic product of gliclazide     (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals     Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product     (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie,     France) when administered to healthy volunteers under fasting conditions. The plasma     pharmacokinetic data of gliclazide obtained from two formulations will be used to access the     interchangeability of the products.   "
49071|NCT02643316|"     Comparison of quality of preparation of colonoscopy in patients taking same day 4L     preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy     procedure.   "
49074|NCT02643277|"     In India, the high diabetes prevalence and cost of its management relative to their personal     income render the country an appropriate environment to seek and test new, less expensive     aids to care. Education and motivation to induce behavioural modification, are important     components of care. Conventional diabetes education programmes involving personal contact     methods are useful but expensive. Compliance with medications is also important and there are     data to suggest that compliance is low in people with established type 2 diabetes (there is     little information on those with recently diagnosed disease). Mobile phones could provide an     inexpensive and scaleable delivery vehicle for components of care. There are now more than 5     billion wireless subscribers and 70% of them live in low and middle income countries. Mobile     phone ownership is high in India and an increasing proportion now has Mobile phones and/or     home computers. The investigators plan a clinical trial in India to assess whether there is     benefit from an enhanced text message intervention delivered by mobile phone in people newly     diagnosed with Type 2 diabetes. The message content will be directed to behavioural     modification, as with our diabetes prevention studies, and will attempt to improve compliance     with drug therapy and other aspects of care, as with our studies in people with established     diabetes. The investigators shall compare effects on glycaemia, other cardiovascular risk     factors, lifestyle behaviour and quality of life, with those observed in people with type 2     diabetes receiving standard care.   "
49075|NCT02643264|"     The purpose of this study is to investigate the effects of repetitive transcranial magnetic     stimulation (rTMS) targeting the insula on alcohol use and neural responses in     alcohol-dependent patients.   "
49076|NCT02643251|"     The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up     Phase. Subjects who qualify to participate will apply study drug to their feet three times     daily and will record their daily pain scores using an interactive voice response system     (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be     randomized to receive Clonidine Gel or Clonidine Gel Comparator.   "
49077|NCT02643238|"     The purpose of this study is to evaluate the use of an artificial vision system called     Brainport system in blind patients To investigate visual, and oculomotor (eye motion)     mechanisms involved in the use of the Brainport system.   "
49078|NCT02643225|"     The aim of this work is the prediction of fetal macrosomia by measuring:        1. HbA1C.        2. Umbilical cord thickness.        3. Interventricular septum thickness.   "
49079|NCT02643212|"     The main objective of the study will determine if patients with liver cirrhosis,     anticoagulation free survival improves hypertension decompensation portal and / or     transplantation without serious side effects. For it is conduct a double-blind multicenter     clinical trial in which patients will be randomized to receive Rivaroxaban or placebo. It     included 160 patients with liver cirrhosis and insufficiency mild to moderate hepatic. It     will also analyze and develop secondary endpoint portal vein thrombosis. The confirmation of     our hypothesis would lead to a radical change in treatment of patients with cirrhosis include     treatment with Rivaroxaban in its drove.   "
49080|NCT02643199|"     The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the     fetal heart from 20-36 weeks of gestation.   "
49081|NCT02643186|"     The study aims at comparison between the effect of preoperative misoprostol and bilateral     uterine artery ligation regarding their effect to decrease blood loss in transabdominal     myomectomy.   "
49082|NCT02643173|"     The investigators will verify the prognosis of hepatocellular carcinoma (HCC) according to     the main anesthetic agents used for the general anesthesia.   "
49083|NCT02643160|"     The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower     extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to     analyze the relation between trunk control and prematurity, birth weight, upper and lower     extremity motor functions in children with spastic Cerebral Palsy.   "
49084|NCT02643147|"     Worsening renal function (WRF) is a frequent finding in patients with decompensated acute     heart failure (AHF) and it is associated to increased length of hospitalization and higher     morbidity and mortality. Traditionally, WRF in AHF setting has been attributed to low cardiac     output, but recent evidence also suggests venous congestion play a crucial role. Loop     diuretics are the mainstay treatment of AHF, but their use traditionally has been associated     to WRF, but also renal function improvement in patients with unequivocal signs of congestion.     Nevertheless, traditional symptoms or signs of patients with AHF have shown a limited     accuracy to neither identify nor quantify the degree of venous congestion. Recent authors     have reported that plasma levels of antigen carbohydrate 125 (CA125) are closely related to     the degree of venous congestion.      The investigators hypothesize that CA125 may have a role for identifying the hyperhydrated     (High CA125) patients that need high loop diuretic doses, and those with normal CA125 values     needing low loop diuretic doses. In this randomized study (1:1) the investigators seek to     evaluate whether a CA125 loop diuretic guided management therapy is superior to a standard     strategy. The primary endpoint is the magnitude of changes of renal function at 24 and 72     hours after initiation of intravenous diuretic in an acute worsening of heart failure   "
49085|NCT02643134|"     The traditional stone row method comprises increasing exercise, drink lots of water, drug row     of stone and stone row position. External physical vibration lithecbole(EPVL) is a     non-invasive device active row of stone, the researchers hope that through this test     prospective clinical study to evaluate the effectiveness of in vitro physical vibration row     of stones after extracorporeal shockwave lithotripsy(ESWL) treatment of stones discharged,     thereby improving after ESWL stone clearance rate.   "
49086|NCT02643121|"     Presepsin (formerly CD14), is a glycoprotein receptor occurring at the surface of     monocytes/macrophages. CD14 binds to lipopolysaccharide (LPS) complexes and LPS binding     protein (LPB), which triggers the activation of toll-like receptor 4 (TLR4), resulting in the     production of numerous pro-inflammatory cytokines. Following Presepsin activation by     bacterial products, the CD14 complex is released in the circulation as its soluble form     (sCD14), which in turn is cleaved by a plasma protease to generate a sCD14 fragment called     sCD14-subtype (sCD14- ST). Plasma levels of sCD14 can be measured using an automated     chemo-luminescent assay (PATHFAST).   "
49127|NCT02642588|"     Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue     level will be compared to women receiving usual practice care i.e. clear liquids only.   "
49090|NCT02643069|"     Frailty is the main risk factor for the development of incident disability in older people     and one of the most important for other adverse outcomes (death, hospitalisation, falls, and     permanent institutionalisation).      Although frailty is a frequent condition in older adults who attend hospitals, little is     known about its true prevalence in different settings of care. Better knowledge of this issue     will inform the rational design of more effective strategies aimed at providing fitted care     for these patients. Thus, the current study will potentially have impact on the quality of     care for frail patients by revealing the prevalence of frailty in different settings of care,     the difficulties in detection and management of frailty in these settings and the best     instruments to detect frailty.      The investigators proposal brings together 6 partners in the European Union (EU) from three     countries, with the common aim of studying the feasibility of a program to detect frail older     patients in high risk clinical settings.   "
49091|NCT02643056|"     Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety     profile of panitumumab in patients affected by Head and Neck cancer after at least one     cisplatin or carboplatin-based chemotherapy. A translational research study is also planned     to evaluate EGFR status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA     sequencing, PTEN protein expression by immunohistochemistry, and HPV genotyping by reverse     hybridization.      Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive     disease, unacceptable toxicity, pregnancy, or patient's refusal   "
49093|NCT02643030|"     The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and     cerebral oxygenation during shoulder arthroscopy.   "
49094|NCT02643017|"     Investigate the effects of dexmedetomidine on postoperative cognitive function in patients     undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.   "
49095|NCT02643004|"     The objective of this study is to compare the clinical performance of senofilcon A lens with     the stenfilcon A lens each for one week of daily disposable wear.   "
49096|NCT02642991|"     This study will investigate performance criteria over one week of daily wear to determine if     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms     of measurement and subjective ratings of visual performance.   "
49097|NCT02642978|"     The purpose of this study is to evaluate the safety and effectiveness of robot-assisted     simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver     metastases, and compared with the traditional open procedure.   "
49098|NCT02642965|"     This phase I/II trial studies the side effects and best dose of liposomal     cytarabine-daunorubicin CPX-351 (CPX-351) when given with fludarabine phosphate, cytarabine,     and filgrastim and to see how well they work in treating younger patients with acute myeloid     leukemia that has come back after treatment (relapsed) or is not responding to treatment (is     refractory). Liposomal cytarabine-daunorubicin CPX-351 is made up of two chemotherapy drugs,     cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking     the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim may     increase the production of blood cells and may help the immune system recover from the side     effects of chemotherapy. Giving liposomal cytarabine-daunorubicin CPX-351 followed by     fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with     relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common     effect of other chemotherapy treatments for acute myeloid leukemia.   "
49099|NCT02642952|"     The purpose of this study is to evaluate by non-invasive methods the change in central     hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic     aneurysm repair.      Our main goal is to measure the changes in:      Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.   "
49100|NCT02642939|"     This is a non-randomized, multicenter, single-stage phase II study of mifepristone in     patients with advanced or metastatic NSCLC who have failed two or more previous chemotherapy     regimens.      The Investigator plans to enroll 18 evaluable patients in Stage 1, and additionally up to 22     evaluable patients in Stage 2 for a total of 40 evaluable patients. Participants will be     followed for overall survival. Current salvage therapy in advanced NSCLC achieves a median     progression free survival time of 10 weeks and overall survival of 10 months. The     Investigator would like to provide evidence that mifepristone will increase the median     progression-free survival time to 15 weeks and overall survival time of 16 months.   "
49101|NCT02642926|"     Since the development a few years ago of bipolar energy in the surgery by operative     hysteroscopy, the hysteroscopic treatment of menorrhagia by endometrial ablation can be     achieved either by the use of monopolar or bipolar current, in parallel with other techniques     labelled as 'second generation' (microwave, radio frequency, thermal destruction ...)     treating the uterine cavity.      It seems that the use of the bipolar energy decreases the rate of adhesions but prospective     data on the success rate after bipolar endometrial ablation are poor and there is currently     no recommendation as to the choice of technique to use. No prospective assessment exists to     date in the literature to compare the difference in efficacy on bleedings when using     monopolar or bipolar current. The goal of this study is to compare these two energies, by     measuring the amount of bleeding calculated by the Higham score 12 months after the     intervention.   "
49128|NCT02642575|"     The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of     ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D     ultrasound   "
49102|NCT02642913|"     The purpose of this study is to test the safety of enzalutamide with or without sorafenib at     different doses. Enzalutamide is approved by the Food and Drug Administration (FDA) for the     treatment of advanced prostate cancer. Enzalutamide blocks a protein called the androgen     receptor. Experiments on liver cancer cells and animal models show that blocking the androgen     receptor causes liver cancer to stop growing. Enzalutamide has not been approved to treat     liver cancer. The investigators want to see if enzalutamide is safe for patients with liver     cancer who have had their tumors grow on sorafenib. The investigators also want to see how     safe and effective sorafenib and enzalutamide are for liver cancer patients that have never     been treated with sorafenib. This is the first time enzalutamide and sorafenib are being used     together. This treatment may not help treat the participant's cancer.   "
49104|NCT02642887|"     Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival     recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel     technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG).      Material and Methods: In this split-mouth study, thirty healthy patients exhibiting two     isolating anterior Miller Class I and II gingival recessions were treated with mTA + SCTG and     cTT + SCTG. Treatment outcomes were assessed at baseline, 3-months and 6-months     postoperatively. The primary outcome was root coverage esthetic scores (RES).   "
49105|NCT02642874|"     Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly     effective drug. Methocarbamol is a central muscle relaxant used to treat skeletal muscle     spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the     inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide     range of safe and effective dosages.   "
49106|NCT02642861|"     Although a number of mechanisms for cramps in liver disease have been postulated and have     been targeted by medical therapies, a clear picture of the causal events has not emerged.     Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and     branched-chain amino acids have shown some benefit in small uncontrolled studies, although     large randomized controlled trials are lacking.      - Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It     is one of the best-studied drug for this application.   "
49107|NCT02642848|"     The purpose of this research is to confirm the efficacy of cartilage regeneration (or stem     cell transplant) simultaneously performed with high tibial osteotomy. Furthermore, as     conventional microfracture surgery on injured cartilage has a disadvantage of the replacement     by fibrocartilage, this research intends to prove the excellence over the conventional     therapy by proving a hyaline cartilage regeneration of injured cartilage by stem cell.   "
49108|NCT02642835|"     Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous     women. The socioeconomic, psychological and physical impacts of prolapse are considerable.     11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment     affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent     prolapse or a failure of the primary procedure. This has lead to the introduction of new     techniques and the use of different materials to augment the repair. Mesh augmented repairs     aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is     associated with complications which are not found in non mesh repairs. 10% of women will have     a mesh complication of which 70% will require a further surgical procedure to manage the     complication. There are extra costs associated with purchasing the mesh, with longer     operating times to insert the mesh and managing complications caused by the mesh. Balancing     the extra risks of mesh surgery against the benefits is probably one of the most contentious     issues in urogynaecology at the present time.      Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in     the use of mesh to support the vaginal wall in prolapse surgery due to risks and     complications being reported. To date there is little evidence regarding the long term safety     and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for     Perigee.   "
49109|NCT02642822|"     In this study, 100 female students aged 18 to 30 years old in Xiamen University will be     enrolled. On the first visit, blood, saliva and urine samples of all participants will be     collected. Then saliva and urine samples will be collected at two-week interval until 6     months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be     used to test CMV DNA by PCR. The primary purpose of this study is to identify the     relationship between baseline PP150-IgG titer and CMV infection.   "
49110|NCT02642809|"     The investigators propose to treat patients with metastatic esophageal cancers and dysphagia     with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is     hypofractionated and will provide a radiation dose of sufficient intensity to induce the     release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of     the design should maximize the chance to examine the hypothesis that radiotherapy can induce     an immune response, which can then be augmented by pembrolizumab treatment. Success in this     study would provide the impetus to conduct further trials aimed at developing this unique     strategy as a more broadly applicable therapeutic option in the treatment of patients     suffering from these deadly cancers, and will provide important mechanistic insights into the     relationship between radiation treatment and immune therapy augmentation.      Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers     in combination with radiation therapy may be a rational treatment strategy for these cancers.   "
49111|NCT02642796|"     Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve     stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.   "
49112|NCT02642783|"     Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte +     ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen,     France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and     oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the     manufacturer's instructions. Descriptive analysis was conducted with trained panelists (N=     14) to create a sensory profile for the solutions and generated attributes were rated on an     unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory     evaluation software. Acceptability testing was carried out with untrained participants (N=80)     and samples were rated on the 9-point hedonic scale. Moreover, a Just-About-Right (JAR) scale     was included for the four basic tastes to determine their compatibility with optimum     taste/acceptability levels in the products.   "
49113|NCT02642770|"     Patients presenting with Left Ventricle (LV) dysfunction undergoing cardiac surgery are at     increased risk of perioperative morbidity and mortality. LV dysfunction has been reported as     an independent predictor of operative mortality in patients undergoing Cardiac surgery. It     also often leads to low cardiac output states with many of these patients requiring inotropic     or mechanical support and vasopressors for hours to days after surgery. Speckle tracking when     combined with three dimensional (3D) imaging techniques might prove to be a more sensitive     marker for ventricular dysfunction. The present study investigates early outcomes in a     consecutive series of patients with LV dysfunction undergoing cardiac surgery   "
49116|NCT02642731|"     Sensitive renal markers have been studied abundantly in connection with open heart, liver and     transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim     of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil     gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty     acid-binding protein), and IL-18 (interleukin -18), in patients without kidney deterioration     undergoing TKA (total knee arthroplasty) as a pilot study before large study concerning acute     kidney injury in orthopaedic surgery.   "
49117|NCT02642718|"     Background: Experimental models using short duration noxious stimuli have led to the concept     of pre-emptive analgesia. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), has been     shown to have a post-operative narcotic sparing effect when given pre-operatively and     alternatively to not have this effect. This study was undertaken to determine whether a     single intravenous dose of ketorolac would result in decreased post-operative pain and     narcotic requirements.      Methods: In a double-blind, randomized controlled trial, 48 women undergoing abdominal     hysterectomy were studied. Patients in the ketorolac group received 30 mg of intravenous     ketorolac 30 minutes before surgical incision, while the control group received normal     saline. The post-operative analgesia was performed with a continuous infusion of tramadol at     12 mg/hour with the possibility of a 10 mg bolus every 10 minutes. Pain was assessed using     the Visual Analog Scale (VAS), tramadol consumption and hemodynamic parameters at 0, 1, 2, 4,     8, 12, 16 and 24 hours post-operatively. We quantified times to rescue analgesic (morphine),     adverse effects and patient satisfaction.   "
49118|NCT02642705|"     The present study aims at evaluating the effect of two innovative treatment strategies in     obese patients: high intensity interval training and hypoxic conditioning. Obese patients     will be randomized in groups performing high intensity interval training, constant load     training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of     the interventions will be measured regarding exercise tolerance, blood pressure, body     composition, metabolic status.   "
49119|NCT02642692|"     The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone     autograft versus hamstring autograft ACL reconstruction in soccer players.   "
49120|NCT02642679|"     The purpose of this single center, prospective case series is to evaluate the effective     management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based     dressing).   "
49121|NCT02642666|"     This pilot project will evaluate yoga as an intervention to improve attention and reduce     challenging behaviors such as hyperactivity and impulsivity, rated by parent and teachers, in     preschool age children with or at risk for attention-deficit hyperactivity disorder (ADHD).     At Risk for ADHD will be defined as four or more hyperactive/impulsive and/or inattentive     symptoms on the ADHD Rating Scale IV-Preschool Version as rated by parents or teachers. Using     a randomized wait-list controlled experimental design, the investigators will explore the     efficacy of practicing yoga for 6 weeks on behavioral symptoms, attentional control using a     computer based tasks of attention, and heart rate variability (HRV), which is a measure of     self-regulatory capacity. The investigators hypothesize that practicing yoga for six weeks of     will improve ADHD and other behavioral symptoms based on parent and teacher rating scales,     which will correlate with improvements in scores on the computer based task of attention as     well as with improvements in HRV.   "
49122|NCT02642653|"     The purpose of the study is to test the efficacy of a 20 week multi-modal treatment comprised     of lovastatin or placebo, and the Parent-implemented Language Intervention (PILI) in children     with FXS. Children will be randomized to drug or placebo in a double-blind design with all     participating in the PILI. The primary endpoint will be to measure improvements in spoken     language and behavior among lovastatin-treated than placebo treated participants.   "
49123|NCT02642640|"     This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose     regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.   "
49129|NCT02642562|"     This study will address whether the additional use of Intravenous (IV) iron on top of     standard care will improve the outlook for patients with heart failure and iron deficiency.     One group of participants will receive treatment with iron injections and the other group     will not receive any iron injections.   "
49130|NCT02642549|"     Girls for Health (G4H) will promote the economic empowerment, agency, and voice of rural     adolescent girls by supporting their transition from secondary school to tertiary training in     midwifery, medicine, nursing and other health careers, and in so doing, will address the     acute shortage of female health workers in rural Northern Nigeria. G4H will integrate proven     girls' education strategies with innovative vocational interventions to build 1350 girls'     career aspirations and academic achievement and will significantly increase the number of     rural girls entering health training institutions (HTI) in four northern states. The program     will include: 1) a bridge program offering accelerated academic instruction in science, math     and English; 2) vocational counseling and practicums at local health facilities; 3) safe     spaces to enhance critical life skills; 4) four month science immersion courses for girls     accepted for admission to a health training institution; and 5) HTI capacity building to     cultivate a rural female-friendly learning environment. G4H will work towards sustainability     from the start by using existing secondary school and HTI infrastructure, and feeding into     government rural health worker employment schemes.      G4H will be evaluated using a rigorous cluster randomized controlled trial design,     randomizing at the school level to assess its impact on key outcomes of interest that include     rural girls' secondary school graduation and subsequent HTI enrollment, retention and     completion, as well as delayed marriage and improved agency and voice. Process monitoring and     costing analysis will be conducted to support quality implementation and dissemination     efforts. The design will ensure that high quality evidence is available to guide the field     regarding the effectiveness and costing of in-school bridge programming in broadening rural     girls' participation in education and career opportunities in the context of low resource     settings characterized by low rates of female participation in education and income     generation.   "
49131|NCT02642536|"     The purpose of this study is to find out which of two programs, MH MOVE! or the enhanced     usual care MOVE! program is most effective in improving participation in and completion of     MOVE! among Veterans with depression, anxiety, and PTSD. One of the treatments, MH MOVE!     provides the standard MOVE! weight management program plus a workbook containing education     for management of depression, anxiety and PTSD symptoms to be used during 10 phone based     clinician led CBT sessions. The enhanced usual care MOVE! provides the standard MOVE! weight     management program plus a workbook containing education for management of depression, anxiety     and PTSD symptoms but not phone calls are provided.   "
49132|NCT02642523|"     The investigators are examining:        1. the relationships of insulin levels and natriuretic peptide hormone levels, and        2. the effects of administering an infusion of natriuretic peptide hormone on the breakdown          of fat      in healthy lean and otherwise healthy obese individuals.   "
49134|NCT02642497|"     This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into     the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration     (I.M. injection of the same dose) with respect to postoperative VAS, first request of     analgesia, total opioid consumption, and with respect to possible side effects.   "
49135|NCT02642484|"     -  Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly          effective drug.        -  Quinine was suggested for treatment of patients with muscle cramps in patients with          liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are          serious side effects.   "
49136|NCT02642471|"     The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been     well studied. However, there were no randomized controlled study on comparing the long-term     outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform     a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy could be     replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage     cervical cancer.   "
49137|NCT02642458|"     PerFECT is a non-interventional, multicenter study designed to document representative     epidemiological data under real life conditions of patients with the diagnosis of metastatic     or locally recurrent, unresectable HER2-positive breast cancer, who are treated either with     pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel as first line     therapy, administered intravenously in a three weekly frequency, thereby reflecting the     treatment regimens established in the CLEOPATRA study.   "
49138|NCT02642445|"     Renal sympathetic denervation from the intima of renal arteries has become an important     method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly     located in the adventitia, and there is no report about renal sympathetic denervation from     the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension,     tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone,     in some patients blood pressure control is still not desirable after resection of tumor     aldosterone. This study intends to conduct renal sympathetic denervation ablation from the     adventitia to observe its efficacy and safety on blood pressure of patients with primary     aldosterone.   "
49139|NCT02642432|"     The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following     12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5     or 6 infection and compensated cirrhosis.   "
49153|NCT02642250|"     Revival of significance and the emergent market of herbal medicinal products necessitate     strong commitment by the stakeholders to safeguard the end users. The variability in the     concentrations of constituents of plant material, coupled with the variety of extraction     techniques and processing steps used by different manufacturers, results in distinct     inconsistency in the quality of herbal products. The present study will be directed to a     polyherbal formulation Entoban which integrates an outstanding blend of herbs that have been     used for decades to eradicate microorganisms and worms from gastrointestinal tract. It is the     combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus     infectoria and Helicteres isora. The current study would target the chemical assessment,     pharmacological and comparative clinical evaluation of Entoban to assure its safety and     efficacy.   "
49140|NCT02642419|"     In patients with atrial fibrillation (AF) complicated with coronary artery disease (CAD),     antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis and     cardiovascular events in combination with anticoagulant drugs. Based on the observations that     the incidence of hemorrhagic complications increased when an antiplatelet drug was     administered in combination with vitamin K antagonist (VKA), the guidelines for     antithrombotic therapy after PCI in the US and EU recommend that DAPT (dual anti-platelets     therapy) should be used in AF-complicated CAD patients for as short a time as possible     following single anti-platelet and VKA, and that monotherapy with VKA should be started from     one year after PCI. In 2013 the European Heart Rhythm Association (EHRA) published the     guidelines for the use of NOACs in NVAF patients, which state that NOACs may have advantage     to VKAs in terms of anti-thrombotic effects in NVAF patients undergoing PCI. However, no     clinical evidence has ever been generated to reveal the efficacy and safety of mono-drug     therapy with a NOACs in stable CAD patients one year or more after PCI.      AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a     rivaroxaban in stable CAD patients. Among NOACs, rivaroxaban was chosen because of the     evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that     rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction     (MI).   "
49141|NCT02642406|"     Despite treatment improvements in breast cancer, a large number of patients still progress to     the metastatic stage. Metastatic breast cancer patients have an extremely unfavorable     prognosis. Not only efficacy, but also quality of life are in the focus when planning a     therapy or therapy sequence for metastatic breast cancer patients. Therapy options include     anti-hormonal Therapy, antibody therapies, other targeted therapies and chemotherapies. One     of the most effective chemotherapies in the adjuadjuvant and metastatic setting is     paclitaxel. However drug handling and its side effects can compromise patients quality of     life and can have an impact on the pharmacokinetics of the drug.      In metastatic breast cancer patients increasing therapy efficacy and reduction of side effect     frequency are considered to be advancements of therapy. One of these advancements is the     development of a cremophor free and albumin bound paclitaxel, nab-Paclitaxel (Abraxane),     which is thought to have a better efficacy and reduced toxicity profile. Nab-Paclitaxel is     approved for the treatment of metastatic breast cancer after a failure of first-line therapy     and when antracyclines are not indicated.      The SERAPHINA study aims to investigate in the use of nab-Paclitaxel in daily routine and the     frequency and perception of side effects.      As a non-interventional study, the SERAPHINA Study will assess the patient characteristics     and describe the patient cohort, in which nab-Paclitaxel is given. This includes age     distribution, molecular epidemiological characteristics and characteristics documented by the     patients themselves.   "
49162|NCT02642133|"     This study is an observational study to determine outcomes of surgical release of tongue-tie     and lip-tie in babies who are experiencing difficulty with breastfeeding.   "
49163|NCT02642120|"     To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage     of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.   "
49142|NCT02642393|"     A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine     whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0     mg/dL) over 2 years slows clinical decline in early PD.      Clinical decline will be assessed as change in the primary outcome variable of the Movement     Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a composite scale     comprising patient- and clinician-reported outcomes.   "
49143|NCT02642380|"     The project was organized by Qilu Hospital of Shandong University in China. In order to     report the efficacy and safety of different cycles of high-dose dexamethasone for the     treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).   "
49144|NCT02642367|"     The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by     some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious     complications. We compared the intubation time and success rate whether or not use of stylet     for endotracheal intubation with McGrath videolaryngoscope.   "
49145|NCT02642354|"     This study will investigate performance criteria over one week of daily wear to determine if     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms     of measurement and subjective ratings of visual performance.   "
49146|NCT02642341|"     This study will investigate performance criteria over one week of daily wear to determine if     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms     of measurement and subjective ratings of visual performance.   "
49147|NCT02642328|"     Traditionally, strength training and power is the main objective of providing only muscle     conditioning, without possible gains on the VO2Max, however, not for aerobic performance.   "
49148|NCT02642315|"     Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main     complication during long-term DA treatment of RLS. This study aims to examine effect of     Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.   "
49149|NCT02642302|"     Based on studies of high intensity interval training (HIIT) in the literature, higher gains     in VO2max and performance are obtained in short periods of training time. However, different     designs training configurations, for example, changing the time interval, could influence     such gains on VO2max and aerobic performance. The aim of the study was to observe the     possible influences of diferetes types of rest intervals in high intensity interval exercise     protocol on VO2max, and the aerobic and anaerobic performances in 12 weeks of training.   "
49150|NCT02642289|"     This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.   "
49151|NCT02642276|"     In this controlled trial, patients with peripheral arterial disease will be randomized to     either maximal walking, submaximal walking, or usual care groups.   "
49152|NCT02642263|"     Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean     delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its     parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In a     double-blind, prospective design patients will be either attributed to the oxytocin or the     carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the     cesarean delivery scar. This will be performed with a von Frey hair, resulting in a     unpleasant feeling in the area of hyperalgesia.   "
49154|NCT02642237|"     To evaluate the bacterial-viral interactions between LPS and Fluenz as a model for sepsis     (bacterial) and Influenza (viral) infections which are common and associated with high     mortality rates in the ICU. To understand these interactions is important for the development     of preventive and therapeutic interventions.   "
49157|NCT02642198|"     This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP)     measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe     Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3     years old patient population. The study is defined according to the International Standard     ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers — Part 2: Clinical investigation     of automated measurement type.   "
49158|NCT02642185|"     This study aims to prove that a strategy of first line local ablation of colorectal liver     metastases with microwaves is not inferior to liver resections in terms of survival rates at     three years with secondary endpoints being survival at five and ten years, interventional     complication rates, length of stay, ablation precision measurements, need for further     interventions and health-economic analysis.      A cohort of 100 patients treated with CT guided microwave ablation of 1-5 metastases <31mm in     size will be followed and compared with propensity scored matched controls from the Swedish     liver surgery registry - Sweliv.      The study is a multi-institutional effort by the Hepato Pancreatico Biliary (HPB) units in     Stockholm Sweden, Bern Switzerland and Groningen in the Netherlands.   "
49159|NCT02642172|"     The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS     75/25) is effective in treating patients with non-alcoholic liver disease.   "
49160|NCT02642159|"     Primary Objective:      To demonstrate the superiority of alirocumab in comparison with usual care in the reduction     of non-high-density lipoprotein cholesterol (non-HDL-C) in patients with type 2 diabetes and     mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with     maximally tolerated statin therapy.      Secondary Objectives:        -  To demonstrate whether alirocumab is superior in comparison with usual care in its          effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C),          apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]),          high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich          lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III),          lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle          size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density          lipoprotein [IDL] particle number).        -  To assess changes in diabetes parameters with alirocumab vs. usual care treatment.        -  To demonstrate the safety and tolerability of alirocumab.        -  To evaluate treatment acceptance of alirocumab.        -  To evaluate PCSK9 concentrations and antibody development.        -  To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other          lipid parameters (subgroup analysis).   "
49161|NCT02642146|"     This study evaluates the efficacy and safety of routine medical treatments of digital ulcers     in patients with systemic sclerosis in a prospective cohort study.   "
49164|NCT02642107|"     Currently, most protocols of nasopharyngeal carcinoma(NPC) of various research bodies such as     the Radiation Therapy Oncology Group require routine elective irradiation to the     retropharyngeal area and to levels II-V, and also to the supraclavicular lymph nodal areas     regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern     of cervical lymph node metastasis in NPC followed an orderly manner. Retropharyngeal lymph     nodes (RLNs) and Level II LNs were the most commonly involved, followed by Level III and     Level V LNs, Level IV LNs, and SCF LNs, and the incidence of LN skip metastasis is rare,     ranging from 0.5% to 7.9%. It was rare for NPC patients without neck lymph node metastases to     experience neck failure after elective irradiation to levels II, III and VA. It also     confirmed that with unilateral LN metastases of higher-level LNs usually spread down     ipsilateral LNs.Thus, the investigators conduct the non-inferior randomized trial to     determine the value of elective neck irradiation in NPC with N0-N1.   "
49165|NCT02642094|"     To examine whether rapamycin can reduce malignant markers and aberrant mammary     stem/progenitor cells (MaSCs) number in surgical specimens   "
49166|NCT02642081|"     The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs     (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In     addition, the investigators would like to assess the risk of admission for acute     decompensated heart failure following exposure to NSAIDs within 30 days.   "
49167|NCT02642068|"     We anticipate that drug-naïve ADHD probands, particularly those with DAT1 or SLC6A2 gene     variants may have higher level of altered microstructural integrity of frontostriatal (FS),     frontoparietal (FP), other hypothesized fiber tracts and decreased brain activity of FS, FP,     and other circuits, deficits in ERP, and impaired EF, SA, IIA and VM than probands without     DAT1 or SLC6A2 gene variants or adult neurotypical. The alterations in the structural and     functional connectivity, neurophysiological and neuropsychological functioning would be     observed in the unaffected siblings as compared to neurotypical. The unaffected siblings will     be in the intermediate position between drug-naïve adult ADHD probands and neurotypical. The     genetic dosage is anticipated to pose the strongest effects on the cortical thickness, brain     volume, gyrification and microstructural property of white matter, followed by     neurophysiology, functional connectivity, and neuropsychological function with the least     effect.      In terms of longitudinal follow-up part, we also anticipated despite increasing thinning of     cortical thickness, microstructural integrity of several targets fiber tracts, and brain     activity of target brain regions and improving performance in EF, SA, IIV, VM from childhood     to late adolescence and young adulthood in the neurotypical group, the slopes of     developmental trajectories of these neuroimaging and neuropsychological function are lower in     the ADHD group.   "
49168|NCT02642055|"     This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in     improving attention skills in children. Half of participants will receive the Neuro+     intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for     the same period. We expect those receiving the Neuro+ intervention to see significant     improvements in ADHD symptoms relative to the TAU controls.   "
49170|NCT02642029|"     The goal of this study is to use transcranial magnetic stimulation (TMS) to investigate the     impact of modulating cerebellar activity on time perception, executive function, and mood and     psychotic symptoms in psychosis patients (i.e., schizophrenia, schizoaffective disorder, and     bipolar disorder with psychotic features) and healthy control participants. The investigators     hypothesize that abnormally reduced activity in the cerebellum contributes to the     abnormalities in patients, that cerebellum-mediated disruptions in time perception may     partially underlie executive dysfunction and symptoms, and that cerebellar stimulation will     normalize disease-relevant outcome measures.   "
49171|NCT02642016|"     This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose     (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with     KIT-positive advanced solid malignancies refractory to standard therapy or for which no     standard therapy exists.   "
49172|NCT02642003|"     Background and Aims: Liver transplantation is the only curative treatment modality for     decompensated cirrhosis and is limited by donor organ availability and financial resources;     thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor     (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been     shown to benefit patients with liver disease. The investigators evaluated the efficacy of     GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.      Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies     were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical     therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At     the end of 6 months their survival were compared.   "
49173|NCT02641990|"     A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect     of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl     estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female     subjects.   "
49174|NCT02641977|"     Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline     treatment with Methotrexate.   "
49175|NCT02641964|"     Try to collect about 350 cases of acute necrotizing pancreatitis at the First Affiliated     Hospital with Nanjing Medical University and Nanjing General Hospital of Nanjing Military     Command. Then the investigators studied the incidence and the risk factors of ARDS in     patients with acute necrotizing pancreatitis.   "
49176|NCT02641951|"     Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve,     the lateral cutaneous branch of the second intercostal nerve that is often resected at     mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral     cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A     second version of the pectoral nerve block is described, called ''modified Pecs block'' or     Pecs block type II.      This novel approach aims to block at least the pectoral nerves, the intercostobrachial,     intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to     provide complete analgesia during breast surgery   "
49177|NCT02641938|"     To investigate the renal protective effect of dexmedetomidine in patients undergoing     cytoreduction and hyperthermic intraperitoneal chemotherapy   "
49178|NCT02641925|"     Many features of the metabolic syndrome are associated with insulin resistance. And,     metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the     investigators hypothesized that visceral fat removal (omentectomy) can make favorable results     for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure     during a surgery for early gastric cancer, the investigators will divide patients randomly     into two groups, total omentectomy group and omentum preserving group.   "
49179|NCT02641912|"     This will be a single center, 7-day, examiner blind, two treatment-arm, randomized,     stratified (Sjogren's Syndrome status [Y/N]), parallel group study conducted in participants     experiencing dry mouth symptoms. This study is designed to investigate the effect of an     experimental mouthwash formulation in providing relief of dry mouth symptoms.   "
49180|NCT02641899|"     A Phase 1, Fixed-Sequence, Open-label Study in Healthy Subjects to Estimate the Effects of     ITCA 650 on Gastric Emptying and on the Absorption Pharmacokinetics of Each of 4 Commonly     Studied DDI Probe Compounds.   "
49181|NCT02641886|"     The purpose of this study is to determine whether the chinese medicine Jian Pi Yi Shen Hua     Tan granules is effective in the treatment of cognitive impairment after acute cerebral     infarction .   "
49182|NCT02641873|"     This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI +     Bavacizumab. This study population is adult Japanese patients with metastatic colorectal     cancers in FOLFIRI + Bevacizumab combination therapy.   "
49183|NCT02641860|"     Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor     Cells Therapy for Knee Osteoarthritis.   "
49184|NCT02641847|"     The purpose of this study is to compare the efficacy and safety between docetaxel combined     with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with     cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel     for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated signature     and validation the efficacy of the signature.   "
49185|NCT02641834|"     The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet     would benefit the cardiovascular risk profile of the participants, compared with a     Mediterranean diet.   "
49186|NCT02641821|"     This is a multi-center, open-label, observational study. The aim of this study is to evaluate     the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with     mild-to-moderate hypertension.   "
49187|NCT02641808|"     Follicular aspiration as well as follicular flushing are standardized techniques and have     been practiced in polyfollicular IVF (in vitro fertilization) therapy for years.     Monofollicular IVF therapy is a standard technique as well. IVF can be done in natural cycles     or with a minimal stimulation with clomifen citrate to achieve a monofollicular response. Our     study aims to compare follicular aspiration and follicular flushing in monofollicular     stimulation. First the investigators want to answer the question whether flushing is     beneficial for the oocyte yield. In case of a positive result the investigators want to     establish a recommendation about the optimal number of flushings taking into account the     duration of the procedure and the pain during manipulation.   "
49188|NCT02641795|"     A first in man clinical trial to asses the the use of am image guided robotic system to     safely and effectively create a minimally invasive access tunnel to the middle ear cavity to     allow access to the round window for cochlear implant electrode insertion.   "
49189|NCT02641782|"     Although the five year survival rate of children with high risk neuroblastoma have increased     over the last three decades from 4 to 44 % (1), neuroblastoma is the second most frequent     cause for cancer related death in childhood (11 %). Most patients show good initial response     rates (complete (CR) and partial remission (PR) rate 95 %), but 55 % experience a largely     treatment-resistant tumor progression.      Recently, a breakthrough with immunotherapy was reported by US investigators from the     Children's Oncology Group (2) using the anti-ganglioside D2 (GD2) monoclonal antibody ch14.18     for tumor cell destruction and granulocyte macrophage-colony stimulating factor (GM-CSF) plus     interleukin 2 (IL-2) for immunostimulation. This immune therapy resulted in an increase of 20     % Event free survival (EFS) at 2 year from randomization. However, this was associated with a     high toxicity rate (pain, capillary leak syndrome).      The proposed trial compares the Childrens' Oncology Group (COG) standard of care arm     (anti-GD2 + GM-CSF + IL-2 i.v. + retinoic acid oral) with an experimental arm (anti-GD2 +     GM-CSF + IL-2 s.c. + retinoic acid oral) designed to reduce toxicity.      The potential benefit from this trial consists of the confirmation that the American trial     design is feasible in an independent set of patients with different preceding therapy, at a     different time point regarding to immune reconstitution after autologous stem cell     transplantation (ASCT), the feasibility of a newly designed immunotherapy (which is hopefully     less toxic) and the investigation of immune response parameters. This pilot study is the     prerequisite for a consecutive randomized clinical trial comparing two immunotherapeutic     approaches in a larger set of patients.   "
49190|NCT02641769|"     This is an open label, single arm, single center investigation to assess the safety and     efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and mesenchymal stem     cells injected into the seminiferous tubules and testis, through a 12 week follow-up period.     The investigators' selected model of research is based on maximizing the efficiency of the     approach by choosing an autologous pattern which preserves the genetic make-up of an     individual that is vital in infertility conditions. Additionally the approach involves     injecting a combination of different but purified cell types which all aid in the retrieval     of spermatogenesis, and the generation of mature spermatozoa. Expected outcomes of this study     are defined in general improvements in infertile patients in regards of testicular     morphology, sexual function, semen quality, development of primary or secondary     spermatocytes, spermatids, or mature spermatozoa in the testis, seminiferous tubules, or     semen.   "
49201|NCT02641626|"     Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital     cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited.     Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to     randomization. Primary goal (treatment): to evaluate the efficacy of urgent vs deferred     coronary angiography in survivors from OHCA without ST-segment elevation in the EKG.   "
49191|NCT02641756|"     The main goal of this study is to identify and characterise the anatomical component of the     replication competent HIV-1 (Human Immunodeficiency Virus-1) reservoir.      The investigators hypothesize that the clinically relevant HIV-1 reservoir is hiding in     various but specific anatomic compartments and is able to rebound when therapy is stopped.      This reservoir is probably smaller than the HIV-1 reservoir hiding in the blood but could be     more transcriptional active because of its specific environment, possibly influenced by lower     concentrations of the antiretroviral therapy.      The current proposal will, for the first time, identify the source of the viral reservoir by     phylogenetically backtracking the viral genome of the rebounding virus to the sequences of     viral DNA (DeoxyriboNucleic Acid) in different anatomical compartments. The subsequent     characterization of the viral reservoir markers (size, integration sites, methylation     profile, stimulation and inhibition assays) will enable us to understand how this viral     rebound occurred.   "
49192|NCT02641743|"     A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate     (>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve     glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired     glucose-tolerant subjects (IGT). The present study intends to understand the mechanism on     postprandial glycemic responses.   "
49193|NCT02641730|"     The purpose of this study is to evaluate the efficacy and safety of guselkumab for the     treatment of participants with palmoplantar pustulosis.   "
49194|NCT02641717|"     Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and     white blood cells per high-power field in self-collected vaginal specimens, compared to     clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan     Health sexually transmitted disease clinic.      Research Design/Plan: Prospective, non-randomized, non-blinded trial      Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg abnormal     discharge, odor and/or itching). Calculate concordance between clinician- and     patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity,     specificity, positive predictive value and negative predictive value of the patient-collected     wet mount, using the clinician-collected specimens as the gold standard.      Clinical Relevance: A wet mount, or microscopic examination, is commonly used to diagnose     trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial     vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests     for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little     information about patient-collected wet mounts exists in the literature. Self-collection by     women before being seen by a clinician can increase the speed and efficiency of the visit.     The method is highly acceptable to women. In the investigators' clinic, women routinely     collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be     burdensome.   "
49195|NCT02641704|"     The aim of this project is a research-based evaluation of a multidisciplinary program     focusing on moving citizens from unemployment and social security benefits to employment and     education in Sonderborg Municipality. The citizens who are assigned cannot readily enter the     labor market or can get education through employment initiatives in the Job Centre in     Sonderborg Municipality because of complex health-related troubles.      The project is designed to include a prospective observational study and a qualitative study     using questionnaires, observations, interviews and informations about employment from the     Sonderborg Municipality.   "
49196|NCT02641691|"     The purpose of this research study is to look at how tumors responds to a short course of     radiation (5 days) followed by 4 cycles of chemotherapy. The standard treatment for people     with stage I rectal cancer is complete surgical removal of the tumor and associated area,     which often means the creation of a permanent ostomy. Recent research has shown that the use     of an organ preservation strategy has shown benefits in people with more advanced rectal     cancers, and so the investigators propose to use a similar treatment strategy in this study     to see if non-operative or less drastic operative therapy (and potentially avoiding a     permanent ostomy) is feasible.   "
49197|NCT02641678|"     Prospective mono-center diagnostic study determining potential discrepancies in identifying     atrial fibrillation by intraindividually comparing different types of follow-up strategies:        1. How many stroke patients with atrial fibrillation are missed by standard stroke unit          24h- electrocardiography, and        2. what is the effectiveness of the extended invasive and non-invasive ECG analysis tools          to detect atrial fibrillation in stroke patients?   "
49198|NCT02641665|"     The level of four biomarkers will be measured in the patients' plasma after induction of     anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these     marker will then be correlated with early (30 days) and late (one year) patients' prognosis     and with functional recovery (MLHFQ score).   "
49199|NCT02641652|"     There is currently no established treatment for paroxysmal hypertension, but selective     serotonin reuptake inhibitors showed good effect in previous reports. This double-blind,     placebo controlled, prospective multicenter clinical trial will assess the efficacy of     sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136     patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and     distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg     daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment     on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated     after 3 months. If proven effective, sertraline might become a standard treatment for this     condition.   "
49200|NCT02641639|"     This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase     2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC     plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC).     Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or     fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC     plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs.     paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to     subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study,     consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study     (Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects     will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.   "
49204|NCT02641587|"     The overall goal of the study is to demonstrate reduction in the levels of biomarkers of     exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) and to     obtain safety information in healthy subjects using the Carbon Heated Tobacco Product 1.2     (CHTP 1.2) as compared to smokers continuing smoking combustible cigarettes (CC) in a     confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.   "
49205|NCT02640612|"     The main objective of this trial is to provide long-term safety, PK, and immunogenicity data     on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who     have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of     patients with drug-related AEs during the treatment phase. The secondary objective in this     trial is the assessment of Long-term efficacy of BI 695501 by evaluation of:        -  the change from Baseline in DAS28 (ESR) at Week 48        -  the proportion of patients meeting ACR20 response criteria at Week 48        -  the proportion of patients who meet the ACR/European League Against Rheumatism (EULAR)          definition of remission at Week 48        -  the proportion of patients with EULAR response (good response, moderate response, or no          response) at Week 48.   "
49206|NCT02640599|"     Investigators will use a stationary bike protocol to investigate whether patients with post     concussion syndrome benefit from adding exertion training to a vestibular rehabilitation     program.      Investigators examine the effect of aerobic exercise testing and training on individuals with     concussion who are currently experiencing symptoms and examine the effect of aerobic exercise     in combination with traditional vestibular rehabilitation.   "
49207|NCT02640586|"     The purpose of this study is to investigate if MRI scans performed after neoadjuvant     radiotherapy can predict the therapeutic response of rectal cancer following preoperative     chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in     the future.   "
49208|NCT02640573|"     Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle     cell disease with typically higher hemoglobin and milder or later disease complications.     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This     can result in painful episodes, serious infections, and damage to body organs. One medication     used to treat sickle cell disease is hydroxyurea.      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with     sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest     syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients but     HbSC patients were not included in the large clinical trials used to test hydroxyurea in SCD,     so less is known about how HbSC patients respond to hydroxyurea.      The purpose of this research study is to see if hydroxyurea, a medication given to many     patients with the most common type of sickle cell, those who are homozygous for the sickle     mutation (HbSS), helps individuals who have HbSC. The investigators will see if it helps by     giving a questionaire when the medication is started, and then every two months at a clinic     visit. The questionaire, called the AdultsQLTM 3.0 Sickle Cell Disease Module, measures     quality of life. The investigators will also see how hydroxyurea changes laboratory test     numbers, and blood thickness.   "
49209|NCT02640560|"     In Italy, few data about anaphylaxis due to peanuts in pediatric age are available,     conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been     collected.      Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and     shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory     (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).      Parent of food allergic children will compile a food allergy questionnaire (questions about     general information on the family, on life and food habits, on indoor environment, on health     status, on clinical aspects of the allergy, on the access to diagnostic and treatment     resources).      Parent of healthy children will compile a control questionnaire (questions about general     information on the family, on life and food habits and on indoor environment) The 1-year     survey will determine the frequency of anaphylaxis in allergic outpatient children.   "
49210|NCT02640547|"     This study seeks to provide evidence of the effectiveness and obtain patient reported     outcomes (PRO) and work productivity data of the interferon-free regimen of Paritaprevir     (PTV)/ritonavir (r) + Ombitasvir (OBV), +/- Dasabuvir (DSV), +/- Ribavirin in chronic     hepatitis C virus infected participants.   "
49211|NCT02640534|"     The purpose of this trial is to test if the combination of enzalutamide and metformin in     patients with castration resistant prostate cancer CRPC progressing on androgen deprivation     therapy ADT is more effective compared to enzalutamide alone. The half of the patients will     receive the experimental treatment combination, enzalutamide and metformin, while the other     half will receive enzalutamide alone.   "
49212|NCT02640521|"     The overall goal of this study is to adapt and preliminarily validate an intervention based     on evidence based approaches to assist smoking parents and other family members of inner-city     children ages 4 to 12 with asthma to stop smoking.This study aims (1) to adapt existing     guideline-based materials used in adult medicine to create a system- and provider-level     intervention for pediatrics and (2) to evaluate feasibility and acceptability of (a)     procedures to recruit inner-city, ethnic minority parents and (b) intervention procedures,     and to estimate intervention effects.   "
49213|NCT02640508|"     The overall purpose of this study is to determine the overall response rate, efficacy and     safety of the combination of eribulin and Lenvatinib.   "
49214|NCT02640495|"     The spread of artemisinin resistant falciparum malaria presents new challenges to both the     control and treatment of malaria. Loss of ring stage susceptibility to the artemisinins might     jeopardize the use of parenteral artesunate as the first line drug for the treatment of     severe falciparum malaria.      The purpose of this study is to assess the effect of artemisinin resistance (defined by a     Kelch13 mutation with known functional significance) in P. falciparum malaria requiring     parenteral artesunate treatment on lactate clearance parameters.   "
49215|NCT02640482|"     The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults     with genotype 2 chronic hepatitis C virus (HCV) infection.   "
49216|NCT02640469|"     Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are     available as hand disinfection options. The purpose of this study is to determine the     relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with     water after scrubbing is complete versus dry hand rubs with alcohol.   "
49217|NCT02640456|"     The aims of the study are:        1. Explore the bacteriology of para- and retropharyngeal abscess.        2. Validate the bacterial findings by exploring antibody development against F.          necrophorum, F. nucleatum and S. pyogenes.        3. Compare bacteriologic findings in concomitant peritonsillar and parapharyngeal          abscesses.        4. Characterize patients with para- and retropharyngeal abscess.        5. Compare the concentration of amylase in para- and retropharyngeal abscesses and neck          abscesses without relation to the pharynx or salivary glands.        6. Perform gene-sequencing of F. Necrophorum strains, and compare these with strains          recovered from patients with acute tonsillitis, peritonsillar abscess, and Lemierre´s          syndrome.   "
49218|NCT02640443|"     The investigators will evaluate whether sulfamethoxazole, a sulfamide antibiotic, improves     the symptoms of primary PREPL deficiency (hypotonia-cystinuria syndrome and isolated PREPL     deficiency).   "
49219|NCT02640430|"     BACKGROUND: Studies have shown that COPD patients with bronchial hypersecretion have     increased risk of acute exacerbations. FREE ASPIRE is an electro-medical device which removes     bronchopulmonary secretions noninvasively, without using a suction catheter and without     generating airway pressure.      AIM: To compare FREE ASPIRE activity with the traditional treatment using PEP-bottle in the     clearance of bronchial secretions in COPD patients METHODS: Forty severe and very severe COPD     patients with mucus and reduced cough will be evaluated. Group comparison will be made     between Intervention group using VAKÜM system (Free Aspire®), and Control group using     traditional treatment with PEP-bottle over 10 daily sessions (20 minutes twice a day).     Primary outcomes are changes in arterial blood gases exchanges, in perceived dyspnea and in     symptom of bronchial encumbrance.      EXPECTED RESULTS: A higher significant reduction of the perceived dyspnea and of perceived     bronchial encumbrance is supposed in the Intervention group. Additional benefits among the     secondary outcomes are also hypothesized in the same group.   "
49221|NCT02640404|"     The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers,     children, adolescents, and adults      Objective:        -  To describe the safety profile after each and any dose (when applicable) of Menactra          vaccine in participants aged 9 months to 55 years for registration.   "
49222|NCT02640391|"     The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical     test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in     patients with quiescent ulcerative colitis (UC).   "
49223|NCT02639624|"     This is a non randomized crossover trial investigating whether changing the pattern of     bicarbonate administration during hemodialysis will result in the more efficient filtration     of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate     dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate     for the second half. The control group will be dialyzed entirely with normal bicarbonate     dialysate. The two groups will switch one week late and patients will serve as their own     matched controls for a completely standard dialysis and one that is split into two halves     with different bicarbonate concentrations.   "
49224|NCT02639611|"     The primary purpose of this study is to evaluate changes in shoulder tightness, chest     tightness, and general pain related to post-mastectomy reconstructive surgery with tissue     expansion in women who are randomized to receive acupuncture treatment immediately after     surgery (twice a week for 6 weeks) compared to those who are randomized to no acupuncture     treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.   "
49225|NCT02639598|"     Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic     options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as     compared with 50 mg/day topiramate.   "
49226|NCT02639585|"     We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real     practice.   "
49227|NCT02641574|"     To examine the relation between complication in Repeated Cesarean Sections and Newborn     Outcome compared to number of repeated cesarean section and reasonf or surgery and personal     medical information to the mother   "
49228|NCT02641561|"     Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP.     Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis.     Despite this, no study to date has evaluated both of these measures for preventing post-ERCP     pancreatitis. It is our hope to evaluate the combination of these two modalities for     preventing post-ERCP pancreatitis compared with either modality alone.   "
49229|NCT02641548|"     This study evaluates the addition of using a sock of silicone to using a heel cream, in the     treatment of heel fissures in people with diabetes, aiming at healing the fissures and     preventing them from developing into ulcers. Half of the participants will use the silicone     sock and a heel cream, the other half will use the cream only.   "
49230|NCT02641535|"     Israel ministry of defense is examining a new BC membrane protective garment of BLAUER     company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The     goal of this research is to perform a comparative experiment in order to evaluate the     physiological strain induced by the new protective garment under exercise-heat stress     conditions, compared to protective garment in current use.   "
49231|NCT02641522|"     The purpose of this study is to evaluate the effects of siltuximab on immune cell functions     in patients with Type 1 diabetes (T1D).   "
49232|NCT02641509|"     Interval colon cancers are an important clinical issue. Literature dealing with technics and     quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated     polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing     that 10% of these polyps were not completely resected. This fact was attributed to size and     histology (the majority of non completely resected ones, were polyps of 10-20 mm and with     serrated characteristics at the histology). In this study the investigators want to evaluate     the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the     margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI)     could be useful in the definition of the margins of the lesion before polypectomy.   "
49293|NCT02640716|"     This study evaluates the efficacy and mechanism of internet-based cognitive training in     patients with subcortical VCIND. Half of participants will receive multi-domain adaptive     internet-based training program, while the other half will receive a fixed, primary     difficulty level task.   "
49233|NCT02641496|"     Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks     for major health problems, including dementia, heart attack, and stroke. Obesity, a growing     problem for Americans and Veterans alike, is the greatest risk factor for the development of     OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high     comorbidity of these risk factors in Veterans, OSA presents a significant health burden to     Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of     Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are     non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment.     The proposed research aims to facilitate adherence to CPAP treatment by testing a novel     cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may     represent an approach that could be applied to the rehabilitation of other chronic conditions     with similar barriers to care.   "
49234|NCT02641483|"     The investigators are testing the effect of electrical stimulation of the rectum on colonic     motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction,     which includes slowed colonic motility, which means that stools take longer than normal to     pass through the colon. This slowed movement may result in chronic constipation and     difficulty emptying the bowels. Individuals typically (without or without caregiver     assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic     motility for a brief period to empty the bowels. The investigators hypothesize that     electrically stimulating the rectum, instead of mechanically stretching it, will produce the     same beneficial effect of improving colonic motility. Therefore, this study will compare the     two methods. If electrical stimulation effectively improves colonic motility, then the     investigator shall develop the approach as a therapeutic intervention in future studies.   "
49268|NCT02641041|"     The primary objective of this study is to assess the safety and tolerability of a single dose     and multiple doses of BIIB033 administered to healthy adult Japanese participants. The     secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of     BIIB033 administered as single and multiple doses in healthy adult Japanese participants and     to assess the single-dose and multiple-dose immunogenicity of BIIB033.   "
49235|NCT02641470|"     Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from     intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant     is native to cool temperature regions of the Northern Hemisphere. Considering its     antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a     significant role in treating various ocular pathologies. The investigators performed a     randomized, case-controlled study in healthy subjects and investigated the protective effect     of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.   "
49236|NCT02641457|"     Aflibercept (Eylea®) and ranibizumab (Lucentis®) are an anti-VEGF, but there are differences     between the two drugs. To determine and compare whether intraocular aflibercept and     ranibizumab decreases rubeosis iridis (RI) in patients with neovascular glaucoma (NVG).   "
49237|NCT02641444|"     The purpose of this research study is to find out how the drugs Truvada®     (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva®     (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital tract.     All of these drugs are very effective at reducing the number of HIV viruses in the blood,     however it is unknown how the drugs move around inside tissues where HIV might be hiding.     This study will determine specifically where in the tissue the drug and the HIV are located     through the use of a new technology that takes creates a picture of the tissue. This     information will help scientists determine the best way to make new drugs to target the     hidden HIV in tissue.   "
49238|NCT02641431|"     This prospective study evaluates the methodology and results of epicardial mapping/ablation     in a large series of consecutive selected BrS patients and to verify if RFA could normalize     the consequences of a genetic disease.   "
49239|NCT02641418|"     Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major     arteries supplying the lower limbs and is associated with an increased risk of mortality and     morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent     claudication (IC). IC presents as cramp like pain affecting 5% of the population >50 years     and is associated with a substantial reduction in walking capacity, quality of life and     diminished physical function. Supervised exercise programmes have been demonstrated to     improve maximum walking distances and NICE recommends group-based supervised exercise for     treating patients with IC. However, there is significant variability in the impact of     treatment across studies and little agreement on the underlying mechanism whereby exercise     increases functional outcomes. Potential mechanisms include skeletal muscle metabolism, VO2     max, anaerobic threshold and endothelial function. Studies are needed to better understand     how exercise improves outcome and in whom, so as to better refine and target the treatment.      The participation of patients with IC in exercise programmes is low. The investigators need     to understand factors influencing participation so that we can improve the number of patients     with IC benefiting from the programme      The research consists of two workstreams:      Workstream one      Objective:      Assess the extent to which patient baseline characteristics and candidate physiological     mechanisms are associated with clinical improvement in IC patients participating in an     exercise programme      Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients     will be invited to participate in a 12 week supervised exercise programme.      Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately     after the completion of the exercise programme and then three months after. Measurements     include:      Baseline characteristics that might predict outcome:        -  Quality of life using the VascuQol questionnaire        -  Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI),          intermittent claudication distance (ICD), Maximum walking distance (MWD).      Candidate physiological mechanisms        -  Aerobic capacity (VO2 max & AT)        -  Muscular strength and endurance        -  Muscle morphology (including muscle thickness, pennation angle, fascicle length and          elastography)        -  Endothelial function (sheer stress response as measured by flow mediated dilation)      Analysis: Regression analysis will be used to explain variation in patient maximum walking     distance at 3 months. The regression will use 9 candidate measures of physiological response     and 3 baseline measures to explore what mechanism and patient factors may be associated with     clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect an     additional increase in variability in MWD explained by each candidate measure of around 5% at     the a 0.05 significance level.      This research will be used to identify which types of exercise may be most influential in     improving outcome and in which patients.      Workstream two      Objective:      Explore the reasons behind patients' participation, non-participation in, experience of and     adherence to the exercise programme.      Study Design: An interview study of patients with IC routinely referred for supervised     exercise. Three groups of patients will be invited to participate. Those who:        -  Choose not to participate in the exercise programme (Group A)        -  Agree to participate in the exercise programme (Group B).        -  Agree to participate but discontinue after at least one session (Group C).      Semi-structured face-to-face interviews with 20 patients per group, interviews will be     conducted using a topic guide to ensure consistency. The format will be flexible to allow     participants to generate naturalistic data on what they consider as important and / or     successful in terms of outcome. Data will be analysed thematically and managed using Nvivo     software - the approach will be inductive and iterative.      This research will be used to redesign the current exercise programme to improve     participation and so the impact of exercise in patients with IC.   "
49240|NCT02641405|"     It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on     Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation     seems be useful in symptoms amelioration in several neurological disease. Few studies have     been performed in Parkinson's disease. A total of 126 patients suffering from PD will be     recruited in 6 italian neurological centers. The study will be a cross-over multicenter study     with the randomization of the sequence. The patients will be randomly assigned to 2 groups     receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait     analysis will be recorded in each patient at the beginning and at the end of the treatment     assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis     recording will be performed. Finally a last recording will be taken at the end of the last 8     weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson     Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific     Balance Confidence Scale).   "
49242|NCT02641379|"     This study will compare the efficacy and safety of 2 different treatment durations of     peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on     study treatment is 1-2 years, and the target sample size is greater than (>) 500 individuals.   "
49252|NCT02641249|"     Purpose of Study: Apnea of Prematurity (AOP) is common, affecting the majority of infants     born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which     contributes to multiple pathologies, including retinopathy of prematurity (ROP), sympathetic     ganglia injury, impaired pancreatic islet cell and bone development, and neurodevelopmental     disabilities. Standard of care for AOP/IH includes prone positioning, positive pressure     ventilation, and caffeine therapy, none of which is optimal. The objective is to support     breathing in premature infants by using a simple, non-invasive vibratory device placed over     limb proprioceptor fibers, an intervention using the principle that limb movements facilitate     breathing.      Methods Used: Premature infants (23-34 wks GA) with clinical evidence of AOP/IH were enrolled     1 week after birth. Caffeine therapy was not a reason for exclusion. Small vibration devices     were placed on one hand and one foot and activated in a 6 hour ON/OFF sequence for a total of     24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2), and breathing pauses were     continuously collected.   "
49243|NCT02641366|"     Deep Brain Stimulation (DBS) is an effective treatment option for individuals with     debilitating tremors that do not respond to medical therapy. However, severe tremors,     particularly those that develop after central nervous system insult or from multiple     sclerosis, can be comprised of several underlying components that represent dysfunction     within distinct brain circuits. Some of these dysfunctional brain circuits can be     successfully treated with DBS while others respond poorly DBS therapy. For severe tremors, it     can be very difficult to discriminate between the underlying components of a patient movement     disorder and is exclusively dependent upon clinical expertise. Even with extensive clinical     experience, it is difficult to reliably predict the results of DBS therapy for patients     suffering from severe, debilitating tremor. In an attempt to gain more knowledge, an     electromagnetic tracking system will be used which can precisely measure the position of a     patient's upper extremity in space during routine neurologic examination. The goal is to use     this tool to quantitatively identify various components of severe tremor, which can be     discriminated based on oscillatory frequency and regularity of tremor amplitude. The purpose     of this research study is to better understand the nature of complex, severe tremors by     carefully measuring movement of the upper extremities with sensors during simple tasks. The     goal is to break down complicated tremors into their components and then determine which     components will respond to deep brain stimulation.   "
49244|NCT02641353|"     The purpose of this study is to assess how much of apremilast is found in the blood unchanged     when administered as an oral suspension compared to when it is administered as a tablet     formulation. The effect of food on apremilast oral suspension will also be evaluated. In     addition, information on the safety and tolerability of apremilast will be obtained.      CC-10004 (also known as apremilast or Otezla®) has been approved by the Food and Drug     Administration (FDA) for the treatment of active psoriatic arthritis (PsA) and moderate to     severe plaque psoriasis in adults. The liquid formulation of apremilast is an investigational     drug being developed by Celgene Corporation to treat plaque psoriasis in children. An     investigational drug is not approved by the U.S. Food and Drug Administration (FDA).   "
49245|NCT02641340|"     The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic     relationship of multiple dose administration of fentanyl sublingual spray in opioid naive     participants. The secondary objective is to determine the safety and tolerability of multiple     dose administration of fentanyl sublingual spray in opioid naive subjects.   "
49246|NCT02641327|"     The study objective is to assess the accuracy of Earlysense contactless monitoring to detect     changes in blood pressure vs. Gold reference method / devices including ambulatory blood     pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have     arterial line as part of their standard clinical care.   "
49247|NCT02641314|"     Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already     one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients     experience further progression.      Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying     vasculature and the interactions between Tumor and immune cells. The toxicity is expected to     be low due to the low (but continuous) dosing of drugs.      The study investigates the tolerance and the efficacy of a new combination of five drugs     consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune     response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic),     etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic,     anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are     applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of     the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been     used in children for other conditions. From those experiences low toxicities and a favorable     Quality of life are expected.   "
49248|NCT02641301|"     The purpose of this study is to determine whether sustained release morphine pharmacokinetics     parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did     not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants     of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969)     the investigators observed changes in pharmacokinetics parameters for immediate release     morphine, probably due to an earlier absorption of the morphine, in agreement with the     expected clinical effect of this formulation.   "
49249|NCT02641288|"     A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve     gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed.     Patients will be randomized in 2 groups: those patients undergoing intraperitoneal     ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal     irrigation with normal saline (Control Group - CG).   "
49250|NCT02641275|"     The relentless progressive process of muscular dystrophy requires extraordinary medical,     physical, and emotional care with severe consequences for caring parents (increased stress     and diminished social, psychological and physical well-being). Despite the obvious need of     support for parents only few and weak data exist regarding efficiency and efficacy of     specific interventions supporting parental resilience and coping strategies. The presenting     study aims to fill this gap by evaluating the efficacy of a structured self-management     training for parents of children with severe progressive muscular dystrophy compared to     parents receiving treatment as usual (TAU). In addition, investigators measure established     biomarkers of psychosocial stress, such as pro-inflammatory cytokines, which will be used to     monitor physiological changes with assumed significance for parental health.   "
49251|NCT02641262|"     ST-segment elevation myocardial infarction (STEMI) remains among the most acute and critical     diseases, with primary percutaneous coronary intervention (pPCI) and thrombolysis as mainstay     reperfusion treatments. Real-world implementation of current guidelines for STEMI management     has been assessed in developed countries and large Chinese cities. However, until now, there     has been no registry on patients with STEMI in Henan, the most populated (about 100 million)     and predominantly rural (66%) province in central China.      This registry is aimed to assess management practices, time delays, outcomes and reasons for     not receiving reperfusion therapy in consecutive STEMI patients in reperfusion-capable     hospitals, i.e., tertiary and secondary, in Henan province.   "
49253|NCT02641236|"     This research study is for participants who are undergoing allogeneic hematopoietic stem cell     transplantation (HSCT) and are at risk for developing acute graft-versus-host disease (GVHD).     GVHD is a complication of HSCT in which immune cells from the donor cause inflammation and     injury to tissues and organs of the HSCT recipient. Vancomycin-polymyxin B (commonly called     vancopoly) is an oral antibiotic that is given to people undergoing allogeneic HSCT as a     preventive measure for acute GVHD. This research study is studying the effects of vancopoly     on the microorganisms living in the intestine during and after stem cell transplantation.   "
49254|NCT02641223|"     For this study the investigators will conduct five-day trial periods for spinal cord     stimulator (SCS) effectiveness—once a patient is deemed to be a possible SCS candidate, the     trial leads are implanted and they are asked to return to clinic in five days to evaluate the     effectiveness of the trial. The primary outcome for this study will be a comparison of daily     energy expenditure (EE), in units of kcal/day, prior to and after the trial implantation of     the SCS leads and external pulse generator. Patients will wear the accelerometer device     twenty-four hours a day for five days prior to the trial lead implantation to obtain baseline     values, have the trial leads implanted in the procedure clinic, then continue to wear the     accelerometer for another five days. Baseline and post-SCS energy expenditure values will be     compared. The secondary outcomes for this study will be steps taken, hours of sleep, and     Oswestry Disability Index (ODI, as described in appendix 1) during the pre and post trial     implantation periods. SCS itself is not a research procedure in this study, rather it is part     of routine medical care for patients who would benefit from the procedure.   "
49269|NCT02641028|"     A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human     Laboratory Model of Smoking Behavior.   "
49255|NCT02641210|"     Periodontitis is an inflammatory/infectious disease of high prevalence in the population and     which has been linked to several chronic inflammatory systemic diseases. However, few studies     have evaluated the periodontal disease in the absence of other inflammatory conditions     stimulate inflammatory markers as C-reactive protein (CRP), Interleukin - 6 (IL-6) hepcidin     and hemoglobin. The aim of this study was to evaluate the influence of nonsurgical     periodontal therapy on the change of inflammatory markers and anemia in control subjects and     patients with chronic periodontitis after three months.This interventional study included 67     individuals of both sexes, aged 30-65 years, without other diseases, except chronic     periodontitis, with at least 20 teeth, selected from a total 125 individuals following the     eligibility criteria. Periodontal clinical parameters (probing depth, bleeding on probing,     clinical attachment level) and systemic, hematological as well as inflammatory markers CRP,     IL-6 and hepcidin were compared before and after nonsurgical periodontal therapy by serum and     plasma examination of control individuals and patients with chronic periodontitis.   "
49256|NCT02641197|"     The objective of this study is to define the repeatability and reproducibility of quantifying     flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD)     methodology.      Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using     the same AD device and operator.      Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but     using different AD devices and operators.   "
49257|NCT02641184|"     The aim of this study is to investigate the potential novel risk factors for acute myocardial     infarction. Predictors of poor outcomes will be also evaluated.   "
49258|NCT02641171|"     This study evaluates the use of exhaled air analysis as tool to monitor the disease activity     in Crohn's Disease (CD). This study is a validation of the previous findings. In this study     the participant will be asked to donate exhaled air, blood samples and fecal samples. The     breath samples will be used to measure various volatile metabolites in breath. The breath air     will be next used to validate the previous findings. The blood samples will be used to define     the origin of volatile metabolites in breath. Finally, the potential of exhaled breath     analysis as non-invasive marker of diseases activity will be compared to established fecal     calprotectin.   "
49259|NCT02641158|"     Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation     intervention in moving HIV/HCV co-infected substance users forward along the HCV care     continuum (compared with a Control group).      Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ     between the two study groups over the 14-month follow-up period.      Secondary Objectives:      Component 1 (Long-term CTN 0049 follow-up):      Using the CTN 0064 baseline data (self-report, medical record abstraction and biological     data), the following CTN 0049 primary and secondary outcomes in participants who consented to     the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the     CTN 0049 interventions:        1. HIV virological suppression        2. HIV primary care visit attendance        3. All-cause mortality   "
49260|NCT02641145|"     Cardiac amyloidosis is a major cause of early treatment-related death and poor overall     survival in individuals with systemic light chain amyloidosis. This project will develop a     novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The     long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to     guide the development of novel life-saving treatments.   "
49261|NCT02641132|"     To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC)     0.02%   "
49262|NCT02641119|"     This observational study evaluates the potential benefits, costs and clinical outcomes of     albumin over saline and other non-saline fluids in patients receiving large volume     resuscitation.   "
49263|NCT02641106|"     The three-month short-course treatment with isoniazid [H] and rifapentine [P] (3HP) recently     recommended by the Centers for Disease Control and Prevention could dramatically increase the     number of persons starting and completing treatment for latent tuberculosis infection (LTBI),     but TB providers nationwide are hamstrung by the requirement that 3HP only be administered by     directly observed therapy (DOT) in which patients are watched taking each medication dose     in-person. We developed a novel mHealth application that allows patients to make and send     videos of each medication dose ingested that are watched by healthcare providers via a     HIPAA-compliant website to remotely monitor LTBI treatment adherence (Video DOT [VDOT]). This     study will determine whether monitoring patients with VDOT achieves higher treatment     completion rates and greater patient acceptability at lower cost than clinic-based in-person     DOT.   "
49264|NCT02641093|"     The purpose of this research study is to test the safety and the benefit of adding     pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of     care treatment for head and neck cancer. The standard of care treatment will include surgery     followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of     care once a week for 6 weeks if the cancer is found to be high risk. High risk includes     cancer that was not completely removed (positive margins) or cancer that has invaded through     the outer lining of your lymph nodes.   "
49265|NCT02641080|"     For patients undergoing total hip and knee arthroplasty, does the use of Aspirin alone     compared to using Aspirin along with a mobile compression device provide equivocal results     for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint     arthroplasty? The investigator will evaluate the prevention of DVT/PE after total hip and     knee arthroplasty will be evaluated to see if there is a decreased risk of bleeding while     continuing to prevent thromboembolic disease. The equivalency of using the mobile compression     devices with aspirin compared to aspirin alone in patients undergoing total hip and knee     arthroplasty will be evaluated. A previous study has shown that patient compliance with the     pneumatic compression device is less than 80%.   "
49266|NCT02641067|"     This study will evaluate the effect of severe renal impairment on the pharmacokinetics of     doravirine.   "
49267|NCT02641054|"     CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and     antidyskinetic activity in a macaque model and has shown a significant effect on the     UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while ON,     as well as an increase of ON-time without dyskinesia or without troublesome dyskinesia in a     previous phase 2a proof of concept study. This study will confirm the efficacy of CVXL-0107     in combination with optimal dose of levodopa on motor symptoms of Parkinson's disease (PD) .   "
49272|NCT02640989|"     The purpose of this study is to assess the safety and immunogenicity of three seasonal     trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac     Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using     imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy     servicemen.   "
49273|NCT02640976|"     The aim of this study is to assess the role of AMH in prediction of poor ovarian response as     well as the relation between ESR2 (+1730G>A) (rs4986938), FSHR p.Thr307Ala (c.919A>G, rs6165)     and FSHR p.Asn680Ser (c.2039A>G, rs6166) SNPs and the poor response in Egyptian women     undergoing IVF procedure. Discovering the genetic variants associated with ovarian response     is an important step towards individualized pharmacogenetic protocols of ovarian stimulation.   "
49274|NCT02640963|"     This study is a pilot study (feasibility and acceptability study), which will compare     feasibility and efficacy outcomes between a 12-week Exercise Program and control group in RAC     residents.   "
49275|NCT02640950|"     Transcranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based     treatment for major depressive disorder. While there is a growing anecdotal database     supporting its use in bipolar depression the investigators propose to collect open label     efficacy and safety data in a small population of patients with clinically verified bipolar     disorder.   "
49276|NCT02640937|"     This was a prospective study performed between November 2011 and September 2013. Patients     with a confirmed S. epidermidis infection after fracture fixation or prosthetic joint     infection were included. Exclusion criteria included infections involving external fixation     pins, infections without any implanted hardware and culture positive patients not displaying     any clinical sign of infection. The following surgical parameters were documented: affected     bone or joint; type of implant; time between implantation of the device and onset of     symptoms. Personal characteristics and patients`health status were also documented. Any     revision surgeries involving the site of interest and all isolated pathogens were recorded     throughout the course of treatment and follow-up.      A follow up examination was performed an average of 26 months after discharge. Primary     outcome at follow up was cure. Cure was define by the authors as: missing local (at site of     interest) or systemic signs of infection, terminated surgical and systemic therapy and     restoration of joint or limb function.      At the first surgical procedure after enrolment, at least four deep bone biopsies were taken     from the interface between implant and affected bone. Identification and antibiotic     susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined     according to the definitions of the European Committee of Antimicrobial Susceptibility     Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays     according to protocol of Stepanovic et al.(see references).   "
49277|NCT02640924|"     Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic     viral hepatitis is common. Patients with HCC typically have impaired liver function because     of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of     them are appropriate candidates for surgery. The 5-year overall survival for patients treated     by surgery is approximately 30%-70%. For those not treated with surgery, liver function     affected by an underlying liver disease has a strong influence on clinical outcomes, and     complicates treatment strategies further than for other tumors. Maximal preservation of     normal liver volume and function is an important consideration in the choice of treatment.      Proton beam has been applied to HCC treatment in Japan for longer than a decade, and several     retrospective results showed excellent 3-5 years local control rate ranging from 85-95% and     nearly no major complications. The investigators also retrospectively reviewed 75 index     tumors sized 3.1-7.0cm in 70 patients receiving multiple-electrode radiofrequency ablation     with switching controller (ME-SWC RFA) treatments in the period between 1 January 2009 and 31     December 2011 (Oral report in Taiwan Digestive Disease Week, October, 2012). Estimated 1-,     2-, and 3-year cumulative overall survival rates and local control rates were 94%, 85%, 81%     and 89%, 83%, 67%, respectively.      Since ME-SWC RFA is the present one of standard modalities for non-surgery, moderate to     larger (3-7 cm) HCC, and based on retrospective studies the local control rate of proton     therapy was better than radiofrequency ablation, this prospective trial is aimed to compare     the effects of these two modalities in 3-7 cm HCC patients who are not candidates for surgery     or refuse surgery. This prospective study has high possibility to confirm the role of proton     beam in HCC.      Along with the clinical trial, the investigators will also use next generation sequencing     (NGS) to exam gene expression profile of tumor samples and find out candidate genes related     to local control, intrahepatic control (treatment out-field control in liver), regional lymph     node relapse, distant metastasis, and treatment response in HCC.   "
49290|NCT02640755|"     This Phase 1, open label, single centre, non-randomised study in patients with advanced solid     malignancies consists of two parts:        1. Single Dose Period - will characterise the absorption, metabolism, excretion and          pharmacokinetics of a single oral dose of [14C]AZD2014 from the body        2. Multiple Dose Period - will further assess the safety and tolerability and anti-tumour          activity of multiple doses of AZD2014 when given as a monotherapy or given in          combination with paclitaxel or fulvestrant.   "
49278|NCT02640911|"     This multi-centre study will evaluate the safety and related factors study of atypical     antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical     antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone,     paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center     observational clinical study. The main purpose is to evaluate the safety. And the second     purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy evaluations     include symptoms, social function, recurrence rate and hospitalization. This study belongs to     IV period post-marketing drugs research. Planned sample size is 3000 cases.      Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical     examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/     blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead     electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function evaluation,     medication and other subjective feelings. The second indexes include scales of Positive and     Negative Syndrome Scale(PANSS)，Clinical Global Impression-severity of Illness Scale(CGI-S),     Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social Performance Scale(PSP),     the MOS 36一item Short Form Health Survey(SF-36), relapse rate, drug consolidation,     medical-related expenses, income, drug plasma concentration and genetic information.   "
49279|NCT02640898|"     Although the intergroup 0116 trial was the first to demonstrate that adjuvant     chemoradiotherapy offers a significant survival benefit in completely resected gastric     cancer,it is more toxic and less effective. It is reasonable to optimize this regimen.   "
49280|NCT02640885|"     Post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower     uterine segment and it occurs after the placenta separation. Although, nowadays the     obstetrician can diagnose placenta previa before delivery, it is still one of the important     causes of maternal mortality . Hysterectomy can be the only effective action to take,     although it carries many morbidities for the women especially those with low parity.      Uterine packing considers as a line of treatment before performing surgical procedures in     postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid     laparotomy and save uterus.      Nowadays, the use of intrauterine balloons have been developed and become effective for the     control of placental site bleeding not responding to medical treatment. The 2-way Foley's     Cather has many advantages over the gauze packing; First, it allows drainage of blood so no     occult bleeding could be accumulated inside the uterus as in uterine gauze, second the     removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way     Foley's Cather could be gradually as a test of its effectiveness before complete removal .   "
49281|NCT02640872|"     This study is a hospital-based, prospective cohort study to elucidate the predictive factors     including muscle and fat mass for chronic diseases and mortality in elderly persons aged 60     years and older.   "
49282|NCT02640859|"     A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic     and other diseases   "
49283|NCT02640846|"     The aim of this study is to compare the effects of milrinone(Corotrope) and     levosimendan(Simdax) on septic cardiomyopathy using pulmonary artery catheter, conventional     and strain echocardiography.   "
49284|NCT02640833|"     This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and     determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in     participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small     lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not previously     received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2 portion of the     study will preliminarily evaluate efficacy, and expand the toxicity evaluation.   "
49285|NCT02640820|"     Warts are benign epidermal tumors caused by human papillomaviruses (HPVs). The active     pharmaceutical ingredient DPCP has been used for many years as a compounded formulation in     acetone for the treatment of warts, alopecia areata and more recently, cutaneous metastatic     melanoma lesions. An improved topical ointment formulation of DPCP called Samcyprone™ will be     evaluated for the treatment of common warts.   "
49286|NCT02640807|"     A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies     of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in     sepsis patients; IRIS-7B (Immune Reconstitution of Immunosuppressed Sepsis patients).      A parallel study will be performed in France to allow a common statistical analysis of the     primary end points and analysis for the enrolled patient population.   "
49287|NCT02640794|"     The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with     aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the     prevention of major ischemic events (MI, ischemic stroke) or death without increasing the     risk of major bleeding events.   "
49288|NCT02640781|"     Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal     malignancies, but emergent surgical decompression is associated with high morbidity and     mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an     alternative to surgery and effectively decompress the colonic obstruction and allow for bowel     preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents     and covered stents. Covered stents have the advantage of less frequent stent occlusion by     tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered     stents are associated with less stent migration, although they appear to be more prone to     tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered     combination covered stent was developed. In the present study, the investigators evaluated     the efficacy and safety of the newly designed covered stent by comparing it with the     uncovered stent in patients with malignant colorectal obstruction.   "
49289|NCT02640768|"     The prevalence of diabetes among inpatients in medical wards, surgery and intensive care     units in Italy is approximatively 12-25%. The management of in hospital diabetes and     hyperglycemia is complex and requires a specific training for physicians and nurses in     non-specialist settings. The overall project aims at the implementation of a best practice     model of care for hospitalized diabetic patients in non-specialist settings.   "
49291|NCT02640742|"     This study aims to evaluate the asthma control status, asthma symptoms (severity, frequency,     and limitations on activities, etc.), QOL, and use of drugs for asthma attack in adult asthma     patients.   "
49294|NCT02640703|"     Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show     diurnal variations in vaccination response, due to circadian regulation of the immune system.     The investigators plan to investigate whether preterm infants also show differences in     hypoxia/bradycardia rate upon morning vs. evening vaccination.      Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours     after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6,     interleukin-1β and C-reactive protein get determined. To control vaccination response,     pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected     age.   "
49295|NCT02640690|"     The proposed study will evaluate the effectiveness of a yoga intervention to treat     posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia,     and biological and physiological responses to trauma and PTSD in women Veterans who     experienced military sexual trauma (MST). If effective, this yoga intervention could reduce     PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic     fight or flight stress response and the damage this stress response causes in the body,     including heart disease and diabetes. This intervention could improve these women Veterans'     quality of life and social functioning, for example, going to work and having satisfying     relationships with family and friends. This study may support an innovative, complementary     and alternative PTSD treatment for women Veterans who experienced MST. This new,     evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines     for this yoga intervention could be implemented nationally in the VA health care system.   "
49296|NCT02640677|"     4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January     2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only     if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur -     before the woman knows she is pregnant, for example. The objective of this study is to     evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of     women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual     period (LMP) or at any time during pregnancy, and the health of their infants. Pregnant women     within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last     menstrual period or at any time during pregnancy are eligible to participate. A woman may     self-enroll in the registry by calling the pregnancy registry telephone number directly or     their healthcare provider (HCP) can, with their consent, enroll them on their behalf.     Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring     within their network/health maintenance organization (HMO). The health of the woman and her     infant will be followed up until the end of the pregnancy.   "
49297|NCT02640664|"     The purpose of this study is to evaluate the long term efficacy and safety of intravitreal     ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy     of prematurity (ROP) in the core study CRFB002H2301   "
49298|NCT02640651|"     The purpose of this pilot study is to determine whether transcranial direct current     stimulation safely and effectively improves symptoms of ADHD.   "
49299|NCT02640638|"     The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can     improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral     outcomes, and decrease the racial difference in selected birth outcomes among African     American and White women, compared to individual prenatal care.   "
49300|NCT02640625|"     The primary objective of this study is to assess the safety of probiotics in cART-treated     immunologic non-responder (INR) patients with chronic HIV infection.      The secondary objectives are to i) explore the biological effects of probiotics in combined     antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii)     investigate differences between cART-treated HIV-infected INR and non-INR patients with     regards to gut microbial composition and mucosal barrier function.   "
49301|NCT02640378|"     Purpose of study is to obtain data on urinary HCG concentrations at >9 weeks of gestation.   "
49302|NCT02640365|"     MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal     formulation is designed to extend plasma circulation and to increase accumulation in the     tumor through the enhanced permeability and retention (EPR) effect.      This study introduces a new concept of combining free and nanoliposomal drugs.   "
49303|NCT02640352|"     The aim of the present study is to test the efficacy of the combination of two probiotic     bacteria in reducing the severity of upper respiratory tract infections (common cold) in     healthy children attending day care or school. The probiotic bacteria used are Lactobacillus     plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9     CFU/tablet and day and will be consumed for a period of 12 weeks.   "
49304|NCT02640339|"     -  To determine whether retinal abnormalities, as measured by high definition optical          coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a          clinical biomarker to monitor disease progression overtime in patients with Parkinson          disease.        -  To establish whether these measures can be used to identify patients with PD in the          premotor phase.        -  To define the rate of progression of retinal abnormalities in PD (both in the motor and          premotor stages) for potential use as a clinical outcome measure   "
49315|NCT02640196|"     The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would     reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated     easy and difficult airways. The investigators have considered to assess the efficacy of each     device in manikins before considering to evaluate them in patients undergoing thoracic     procedures.      Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT     intubation participated in this randomised crossover study. Following a brief demonstration     and two practice attempts, participants were volunteered to insert a DLT using the Macintosh,     GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway     simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT     intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of     laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an     attempt took longer than 150 seconds, were recorded.   "
49305|NCT02640326|"     It is common practice to insert a Foley catheter into the bladder to drain urine during and     after a lung resection. Recently, there has been increasing interest in the potential risks     associated with this catheterization, particularly with regard to infection. As thoracic     surgery adopts minimally invasive surgical techniques, the need for urinary catheterization     during surgery is being questioned since these less invasive surgeries are known to result in     less post-operative acute pain, shorter length of stay, and other outcomes that tend to     decrease overall anesthetic needs for this patient population. Thus, there is a need to     investigate whether patients who have had a minimally invasive lung resection truly need the     Foley catheter at all. This will be achieved by assigning patients to either an experimental     no-catheter group or the standard of care routine urinary catheter group to determine if     patients with no catheter experience different rates of complications. This pilot study will     primarily determine if such a study is feasible and will test the suitability of new patient     quality of life tools. Secondarily, the study will look to see if there is a difference in     post operative urinary complications between the groups. Should this study prove to be     feasible, the information learned will be used to determine the sample size and requirements     for a fully powered trial, in order to definitively determine whether a Foley urine catheter     is a necessary procedure in the course of a minimally invasive lung resection.   "
49306|NCT02640313|"     Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a     sensitive molecular tracer for PET imaging that is taken up in activated cells and, as such,     is able to identify active inflammatory sites. The investigators hypothesize that 18F-choline     is also highly taken up in vulnerable plaques in comparison to the stable ones.   "
49307|NCT02640300|"     Clozapine has been demonstrated to be clinically superior to other antipsychotics in     treatment-resistant schizophrenia (TRS), and is positioned as such in treatment guidelines.     Because it is relegated to use in TRS, guidelines require that it only be used after other     antipsychotics have failed; accordingly, clinicians routinely contend with stopping the     previous antipsychotic in making the switch to clozapine. Perhaps because of its numerous and     potentially severe side effects, the issue of clozapine titration has frequently been     addressed, although to our knowledge no study has, as of yet, assessed the comparability of     gradual vs. immediate antipsychotic discontinuation in switching to clozapine. To address the     gap in knowledge specific to clozapine, the investigators conducted a pilot, 8-week,     double-blind, randomized controlled trial examining immediate vs. gradual antipsychotic     discontinuation in patients with schizophrenia undergoing a switch to clozapine.   "
49308|NCT02640287|"     Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present     poorly understood, although a recurrent mutation (L265P MYD88) has recently been described.     Unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism     involving AID and NHEJ complex. Using a two-dimensional electrophoresis technology, our group     showed that MW had a specific proteomic profile, and one of the differentially expressed     proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .      The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6 (genetic     or epigenetic modification) in comparison with other lymphoid malignancies and normal B     cells.   "
49309|NCT02640274|"     The European guidelines of cardiovascular disease prevention recommend treatment modalities,     such as lifestyle changes in order to minimize the risk of further cardiac event after a     myocardial infarction (MI). However, a considerable gap exists between guidelines and their     implementation in clinical practise. Further, less is known about the impact of different     interventions on patient's knowledge, skills and confidence necessary for self-management     after MI.      Aim: To evaluate and compare the short- and long-term effects of an individual nurse-led     counselling programme together with usual care for patients early discharged after MI on     self-management behaviour.   "
49310|NCT02640261|"     The objective of our observational prospective study will be to compare, for women treated     for infertility and included in a ICSI program, the implantation rate and delivery rate     obtained after the transfer of a single blastocyst , chosen in a group of patients on the     basis of the embryo morphology and in the other group on the basis of both embryo morphology     and follicular fluid cytokines content.      100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously     stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who     have had a low ovarian response, Fort < 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will     be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH ,     according to the standard established by our clinical practice.      Patients will be part of one of the following groups:      Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria     Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological     criteria and levels of cytokines measured in the individual FF.   "
49311|NCT02640248|"     The investigators have devised a simple method to continuously measure the CP using an     invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to     monitor arterial or central venous pressures. The investigators have previously confirmed     both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement     of the IPMS readings with the values obtained from a standard manometer (gold standard). In     the current study, we will prospectively evaluate the relationship between the patient's head     position and CP in patients undergoing otolaryngological surgery and also measure the oxygen     concentration in the oropharynx to determine the potential risk of an airway fire.   "
49312|NCT02640235|"     The study is to evaluate the effectiveness and safety of CELSTAT vs active control.   "
49313|NCT02640222|"     The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and     Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data     from SNIIRAM (French data base).   "
49314|NCT02640209|"     Open-label pilot study to determine safety and efficacy of CART-19 cells in combination with     ibrutinib. The target dose will be 1-5x10xE8 CART-19 transduced cells administered via split     dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3. 15 evaluable subjects (adults) with     relapsed or refractory CLL/SLL who have achieved partial response or stable disease on     ibrutinib therapy will be eligible to receive CART-19 therapy.   "
49316|NCT02640183|"     The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g     cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy,     using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia     that may be required for some cases of office hysteroscopy.   "
49317|NCT02640170|"     The purpose of this registry is to monitor the rate of recurrence in patients who undergo     cancer surgery.   "
49318|NCT02640157|"     The purpose of this study is to compare the safety and efficacy of ABT-493/ABT-530 to the     combination of Sofosbuvir (SOF) and Daclatasvir (DCV) in adults with genotype 3 chronic     hepatitis C virus (HCV) infection.   "
49319|NCT02640144|"     This is a prospective, double blind randomized controlled trial. In this study we will     investigate the influence of hyaluronic acid injection to knee after knee arthroscopy, when     known or discovered cartilage damage greater than International Cartilage Research Society     score (ICRS) grade 2 is found. The indication for arthroscopy is not necessarily the     cartilage damage. A set of 3 consecutive injections will be administered and follow up of     physical examination and questionaries will be done.      Our null hypothesis is that the administration of hyaluronic acid will show decrease pain and     quicker rehabilitation and return to normal activity in patients with grade 2 and higher     cartilage damage that had gone through knee arthroscopy.   "
49320|NCT02640131|"     The burden of sexual dysfunction after prostate cancer surgery is responsible for the single     greatest impact on patient/partner health-related quality of life; substantially more so than     concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is     a great need for progressive and distributable sexual health rehabilitation interventions     designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial     intervention is ultimately found beneficial, it will result in: 1) an empirically-based     intervention that helps patients/partners maintain optimal health-related quality of life     after prostate cancer surgery, and 2) a highly structured protocol and manualized     intervention that is translatable to other treatment groups (e.g. radiation therapy) and     University/Community-based hospitals.   "
49321|NCT02640118|"     Postprandial glucose (PPG) excursions are not only determined by insulin-mediated glucose     disposal and endogenous glucose production (regulated by insulin and glucagon); also the rate     of gastric emptying constitutes an important determinant of PPG levels 1. The short-acting     glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide is used in the treatment of     type 2 diabetes. It increases glucose-dependent insulin secretion, suppresses glucagon     secretion and reduces gastric emptying of meals 2. These three mechanisms most likely     constitute the weightiest mechanisms behind the potent impact of lixisenatide on exaggerated     PPG excursions in patients with type 2 diabetes - which often are normalised during     lixisenatide treatment 3. However, the separate impact of lixisenatide-induced reduction of     gastric emptying (independently of the pancreatic effects) has been difficult to determine.     Importantly, treatment with lixisenatide also decreases appetite and food intake and may,     like native GLP-1, increase energy expenditure 4. So far an exact demarcation of the     pancreatic and extrapancreatic effects of lixisenatide in humans remains to be established.      The present project serves to determine whether effects of lixisenatide on gastric emptying,     appetite, food intake and resting energy expenditure are dependent on the endocrine pancreas.      The study is a randomised, placebo-controlled, double-blinded, cross-over study.      12 healthy persons and 12 pancreatectomized patients (i.e. patients who have had their     pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected     to two experimental days on which they will undergo a liquid meal test followed by a fasting     period and finished off with an ad libitum meal with lixisenatide and placebo, respectively.   "
49322|NCT02640105|"     Cluster headache (CH) is one of the most painful primitive headaches. Developments in     neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic     system, which is similar in patients with addictions. CH has strong links to the vascular     system but there is no study measuring endothelial function in CH sufferers.   "
49323|NCT02640092|"     The purpose of this protocol is to evaluate the longitudinal change in tau burden using     [18F]MNI-798, tau targeted radiopharmaceutical compared to baseline in prodromal, mild, and     moderate AD subjects and in similarly-aged HV subjects.   "
49324|NCT02640079|"     The purpose of this study is to test the feasibility and efficacy of a brief group therapy     treatment program focused on reducing pain catastrophizing in adolescents and young adults     (ages 16-25) with menstrual pain.   "
49325|NCT02640066|"     Acute viral respiratory infections are among the most common causes of hospitalization in the     pediatric population. The usual presentation of viral respiratory tract infections (VRTI)     includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite. Up to 50%     of children will have at least one viral-induced wheezing illness by school age. Currently     treatment of VRTI is essentially supportive and no specific and efficient treatments are     known. Given the lack of effective medications, current treatment for severe viral lower     respiratory tract infection (LRTI) in infants relies on supportive measures only. These     measures include supplementation of oxygen, monitoring of apnea, nasal/gastric tube feeding     or intravenous fluids, and, if required, respiratory support with nasal bi-level     positive-airway pressure. VTRI therefore represent an important unmet need for improved     treatment strategies. Acupuncture's effect on has also been studied. Acupuncture has been     shown to be a safe and effective in various respiratory tract inflammations. A review     published in 2011 have found that acupuncture is safe for pediatric patients. Acupuncture's     effect on acute viral induced wheezing and cough in hospitalized children has yet to be     studied. Since the current standard of care is supportive care only, using acupuncture as an     additional treatment may provide benefit in reducing wheezing, respiratory distress, and     shorten hospitalization.   "
49326|NCT02640053|"     This randomized pilot clinical trial studies topical cryotherapy (cooling hands and feet with     ice bags) in reducing pain in patients with chemotherapy induced peripheral neuropathy or     paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes     pain, numbness, tingling, swelling, or muscle weakness in different parts of the body.     Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy is     being studied to see if it can help relieve pain from peripheral neuropathy or acute pain     syndrome caused by chemotherapy.   "
49327|NCT02640040|"     The study aims to evaluate the clinical result of Combined Surgery in Management of     Congenital Pseudarthrosis.   "
49407|NCT02638935|"     The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization     can improve the diagnostic accuracy with respect to detection of malignancies, in particular     for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in     categories 3 and 4a according to a predefined VTIQ cut-off value of 3.5 m/s (37 kPa).   "
49634|NCT02635971|"     This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine     and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan     University Institutional Review Board which has Federal Wide Assurance through the U.S.     Department of Health & Human Services (Approved: April 25, 2002).   "
49328|NCT02640027|"     Fractures of the supracondylar region of the humerus are among the most common pediatric     injuries requiring the attention of an orthopaedic surgeon. Children with non-displaced     fractures (Type I), as well as those with history of elbow trauma, have been traditionally     managed with non-surgical immobilization. Recently published clinical guidelines support such     practice, based on the result of two prospective studies in which either collar and cuff or     posterior splint immobilization were used. When compared to collar and cuff immobilization,     posterior splints resulted in better pain relief within the first two weeks of injury;     however, critical outcomes, including the incidence of cubitus varus, hyperextension, and     loss of reduction, were not reported.      While posterior splints appear to be an attractive option for the treatment of non-displaced     pediatric elbow fractures, a recent retrospective analysis on the use of posterior splints     for the treatment of such injuries reported a small proportion of fractures demonstrating     displacement. The potential for non-compliance with the use of removable devices, especially     in the older pediatric population, is also a concern.      The use of a removable immobilization that can reliably maintain fracture alignment, minimize     the risk of non-compliance, and result in similar outcomes as those obtained with regular     casting could be advantageous: It appears that such immobilization could be removed easily     and safely at home, potentially resulting in a lower number of patient visits, decreased     health-care costs, and higher patient/parent satisfaction.      Telemedicine, defined as the use of telecommunication and information technologies in order     to provide clinical health care at a distance, has been seldom used in the field of pediatric     orthopaedics. Commonly mentioned attributes of telemedicine include improved access to     healthcare providers, cost containment and increased healthcare efficiency, quality care     improvements related to patient satisfaction, and potential reduction in travel time for     patients and families.      The purpose of this randomized, controlled, prospective study is to assess telemedicine as a     tool for the treatment follow-up of non-displaced SCHF fractures in children. Investigators     hypothesize that using telemedicine will result in comparable clinical outcomes as those     obtained in patients treated in a clinical facility, with increased patient satisfaction and     decreased healthcare costs.   "
49329|NCT02640014|"     The outcomes of oral immunotherapy (OIT) in food allergy study will provide more knowledge of     oral immunotherapy. So far the OIT has showed in clinical experiments to be a interesting way     to increase the unresponsiveness in severe food allergies. However little is known about it´s     long-term outcomes, immunological mechanisms and there are no previous studies about     cost-utility of OIT.   "
49330|NCT02640001|"     In patients on mechanical ventilation, it is not known whether the identification of S.     aureus in LRT samples improves the performance of its nasal detection.      To assess the MSSA or MRSA carrier status of patients requiring mechanical ventilation for     more than 48 hours after major heart surgery: comparing the performance of the diagnostic     technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.   "
49331|NCT02639988|"     The purpose of this study is to determine whether patients with rheumatoid arthritis and type     2 diabetes experience a more severe disease course compared to control patients with     osteoarthritis and type 2 diabetes   "
49332|NCT02639975|"     The proposed trial a Randomized, Double Blind, Placebo Controlled first in-human Study to     Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-677 in Male Healthy     Volunteers (Protocol Code No:CUNFI-1509 EudraCT No:2015-003546-57) will be a single-centre,     randomized, double-blind, dose escalation study without therapeutic benefit, in which PBF-677     will be administered as single, oral, ascending-dose to volunteers.      Up to four different rising doses (100 mg, 200 mg, 400 mg and 600 mg) will be tested in     groups of 8 participants; in each dose level participants will be randomized to active drug     or placebo in a 6:2 fashion. As this will be the first time that PBF-677 in going to be     administered to humans, as a safety measure a stepwise drug administration will be performed     in each cohort. The volunteers of each cohort will be divided in 3 blocks/subgroups:     Initially, one volunteer will receive active drug (subgroup 1). After 48h of safety and     tolerability assessment, a second subgroup of 3 volunteers will receive 2 active drug and 1     placebo and after further 48h of safety and tolerability assessments a third subgroup of 4     volunteers will receive 3 active drug and 1 placebo. After evaluation of safety, parameters     of corresponding dose level the process will replicate one week afterwards in the following     dosages.      The principal variable safety and tolerability of PBF-677 will be evaluated with physical     records (Electrocardiogram (ECG), vital signs, blood chemistry and haematology, conducted     before, during and after study course). Assessment of the pharmacokinetic profile (Maximum     plasma concentration of the drug (peak) after single dose (Cmax),Time necessary to reach Cmax     (tmax), Area under the time-concentration curve to zero to time t (AUC0t), and     Elimination half-life (t1/2) of PBF-677 will be included as secondary variable.   "
49333|NCT02639962|"     Identifying patients who are at risk for a future myocardial infarction, is still one of the     biggest challenges in cardiology.      In this study the investigators will investigate culprit lesion in patients with NSTEMI and     the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe     and identify plaques that may be vulnerable. The investigators will also describe changes in     characteristic in both stable and unstable plaques during 1 year follow up of NSTEMI and a     matching group of stable angina pectoris (SAP) patients.   "
49334|NCT02639949|"     Nonadherence to medication is a major obstacle to successful treatment of renal transplant     patients. This study has two primary aims. The first is to test whether a culturally     sensitive cognitive-behavioral adherence promotion program could significantly improve     medication adherence to tacrolimus prescription. Participants will be randomly assigned to     either group CBT or to standard care. The second aim is to pilot a novel strategy of     adherence measurement - unannounced telephone pill counts, which has been shown to be a valid     and reliable means to measure medication adherence in other patient populations. Participants     will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical     Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to     start of the intervention in order to establish baseline adherence and three pill counts will     be conducted post-intervention. Tacrolimus trough concentration levels will also be collected     as an additional biological measure of adherence.   "
49335|NCT02639936|"     Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube     test) in immunocompromized patients   "
49336|NCT02639923|"     The aim of this study is to investigate the early serum measurement (<6h after injury) of     mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions     (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions     (CCT neg.).      S100B serum levels will be measured in both groups. The usual risk factors for the occurrence     of an intracranial hematoma (diagnostic algorithm) will be recorded. Additionally, a group of     healthy individuals will serve as a control group.   "
49337|NCT02639910|"     This is a two-cohort, multicenter, open-label study of MOR00208 combined with idelalisib or     venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g.,     ibrutinib) as single agent or as part of combination therapy.   "
49338|NCT02639897|"     Direct laryngoscopy and intubation is an essential initial aspect of airway access during     general anesthesia. To perform the procedure effectively, it requires adequate mouth opening,     head and neck movement, and a normal temporo-mandibular joint mobility. Any issue with the     above three results in a compromised upper airway at the outset and the condition is known as     anticipated difficult airway, i.e. an airway that is difficult to access with conventional     laryngoscopy and intubation methods. To overcome the difficulty, either one has to resort to     newer advanced technique and equipment or the available conventional technique needs to be     refined and modified to suit the requirement. While the former requires extraordinary     expertise and finances, an option difficult to achieve in developing countries; the latter     warrants focused interest to develop alternative approach with the same set of equipments.      Since submucous fibrosis and the associated restricted mouth opening have taken the     proposition of an epidemic owing to widespread use of betel nut and tobacco; these patients,     when requiring surgery, are difficult candidates for GA and airway control. The fact that,     when they arrive as pre-surgical candidates, they have variable degree of mouth opening     restriction, which if approached with a strategy, may be amenable to conventional control of     airway. If investigators paint all the patients with mouth restriction as difficult airway,     it will result in uncalled surgical, economic, health system and psychological burden.     Therefore, it is prudent to undertake research relating to refinement of airway access     techniques with the easily available, cheap and user- friendly equipment (conventional     laryngoscope), such that a proportion of above stated burden can be reduced.      In view of the above, investigators plan to undertake a study to enhance our working     knowledge with a conventional laryngoscope (Macintosh) to facilitate ways to control the     airway difficulty secondary to mouth opening restriction. Investigators believe that the     prospective knowledge thus generated would help us identify whether there is a feasibility of     conventional airway management or an alternative advanced access technique is needed in the     first place. This will prevent undue cancellations, delayed surgeries, and patient morbidity.   "
49339|NCT02639871|"     There is no curative treatment available today in Huntington disease (HD) despite the     identification of the mutated gene 20 years ago. Nonetheless, safe and promising therapeutic     strategies targeting brain energy metabolism are now becoming available.      In view of the small effect sizes of any clinical parameter in HD, robust neuroimaging     biomarkers reflecting brain energy metabolism are therefore urgently needed to better assess     the potential of therapeutics targeting the mitochondria, and especially the Krebs cycle.     Identifying such biomarkers at the presymptomatic phase in HD also provides a unique window     for therapeutic intervention, which can be used as a proof-of-concept for the real challenge     of tomorrow's medicine: the prevention of neurodegeneration HDeNERGY is an observational     study consisting of the transfer of methods from preclinical to clinical studies and their     application in HD. HDeNERGY aim at optimizing MRI/MRS methods to study the dynamics of brain     energy metabolism. At the CENIR (Centre de neuro-imagerie et de recherche, Paris) the     determination of creatine kinase rate will be first validated in healthy volunteers (n=20)     and then applied to the selected cohort of early affected HD patients (n=20), presymptomatic     individuals (n=20) and controls (n=20) together with the methods previously validated in HD     patients (Mochel et al., 2012b) to determine the ratio of inorganic phosphate (Pi)/     phosphocreatine (PCr) during visual stimulation in presymptomatic individuals. The Chemical     Exchange Saturation Transfer (CEST) method on the 3T clinical scanner of CENIR will be first     validated in healthy volunteers (n=20) and then applied to the selected cohort of early     affected HD patients (n=20), presymptomatic individuals (n=20) and controls (n=20).      The cerebral synthesis rate of creatine phosphate and of brain glutamate concentrations and     pH values will be compared between controls, HD patients and HD presymptomatic individuals,     and correlated with clinical parameters (age, BMI, UHDRS).   "
49340|NCT02639858|"     A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or     metastatic head and neck squamous cell carcinoma   "
49341|NCT02639845|"     The purpose of this study is to determine if an eye drop video monitoring device can     accurately assess (as compared to a patient's own log or a proprietary software) the exact     amount and time of eye drop delivery to a patient's eye. It is our belief that the     experimental device will help patients to be more compliant by: 1) providing a viewable     format so patients can see what is happening when they are applying their drops 2) providing     greater accuracy to doctors regarding when and how much medication was used 3) providing     greater accuracy to doctors and patients regarding how much medication was actually delivered     to a patients eye.   "
49342|NCT02639832|"     The purpose of this research study is:        -  To test blood for the presence of tumor derived circulating tumor cells (CTCs) or          circulating tumor DNA (ctDNA) using an investigational medical device called the          LiquidBiopsy®. Using the LiquidBiopsy® platform, recovered cells or DNA can also be          investigated to obtain genetic information that may be useful to treating physicians in          understanding disease.        -  To test blood for natural killer cells (NK cells), which are part of the body's natural          immune defense against tumors. A device called the NK VueTM Kit will be used for this          test.      The LiquidBiopsy® is a new investigational device. An investigational device is one that is     not approved by the United States Food and Drug Administration (FDA). The NK VueTM Kit is an     investigational device in the United States but is approved in Canada and South Korea as a     class II device.      If a tumor is present, very tiny numbers of tumor cells or the contents of these tumor cells     can get dislodged from the tumor and swept into the bloodstream. The LiquidBiopsy® device is     able to purify the tiny numbers of tumor cells or ctDNA in the blood. Even if a tumor is too     small to be found by other means such as an x-ray, it is possible that ctDNA or CTCs may be     found in the blood. Genetic information can then be recovered from these cells or DNA to look     for genetic changes that are related to the abnormal growth in a tumor. This will potentially     allow researchers to study tumor cells or tumor DNA from a blood sample instead of a biopsy     sample. This may influence cancer diagnosis, treatment and drug selection in the future.      NK cells occur naturally in the body and kill tumor cells. This study will measure the     activity of the NK cells in blood. A strong correlation between low NK cell activity and     increased circulating tumor cells in blood has been reported.   "
49343|NCT02639819|"     This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in     ICH patients.      Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting within     3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will be     consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid over     1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head will be     done at 24 hours in order to follow hematoma size. Electrocardiogram, lower extremity venous     Doppler and NIHSS will also be done at 24 hours. The patient will be followed in the clinic     30-90 days post discharge for functional status.   "
49344|NCT02639806|"     This study evaluates the outcomes of stroke patients treated for intravascular thrombectomy,     using either a local anesthetic with sedation, or a general anesthetic. Historical data will     be used for those treated with the local anesthetic, and prospective data will be used for     those treated with the general anesthetic.   "
49345|NCT02639793|"     The study will assess the atrial fibrillation burden recorded By implantable loop recorder at     12 and 24 months compared to baseline. The patients with clinical indication fo catheter     ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual     radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and     cryoablation.   "
49346|NCT02639780|"     The investigators will define procoagulant properties of packed red blood cells and     investigate whether packed red blood cells from certain donor populations are prone to induce     procoagulant states.   "
49447|NCT02638402|"     To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human     ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression     profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in     various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and     tissue microarrays.   "
49448|NCT02638389|"     The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of     rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular     organisations.      The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.   "
49347|NCT02639767|"     The purpose of this study is to evaluate the safety of combining chemotherapy at different     doses with a specific type of radiation therapy delivered to the entire lining of the lung to     find out what effects, if any, it has on people. This radiation technique is called pleural     intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining of the     lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. When     given after chemotherapy, pleural IMRT has demonstrated promising results with respect to     keeping mesothelioma under control longer. However, the investigators want to determine if     giving pleural IMRT at the same time as chemotherapy is safe. If safe, further studies will     be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor under     control for a longer period of time than chemotherapy followed by pleural IMRT.   "
49348|NCT02639754|"     Young men who have sex with men (MSM) in low- and middle-income countries often do not seek     out HIV testing, are unaware of their HIV-positive status, and do not receive early medical     care, compromising their health and contributing to downstream disease incidence. This     situation is of great concern in post-socialist countries of Eastern Europe, where stigma     about HIV/AIDS and same-sex behavior are great, HIV epidemics are still increasing, and the     health needs of young MSM are rarely acknowledged or addressed. The planned research will be     conducted in Sofia, Bulgaria, where MSM account for nearly half of HIV infections. The study     will be conducted in two phases.   "
49349|NCT02639741|"     The investigators designed a randomized double-blind placebo-controlled trial to evaluate the     effect of preoperative single dose of oral melatonin and vitamin C administration on     postoperative analgesia in patients undergoing elective major abdominal surgery.   "
49350|NCT02639728|"     The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee     stimulates colonic activity, most notably in the transverse/descending colon, in magnitude     similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. [1]     Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory     threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is     significantly higher than after water intake. This may result in an earlier desire to     defecate. [2] Coffee has also been shown to have an effect on defecation by increasing rectal     tone by 45% (measured with a barostat) thirty minutes after consumption. [3]   "
49351|NCT02639715|"     The aim of this observational study is to describe for the first time a complete set of     morphometric and morphokinetic parameters of frozen-thawed human embryos in order to select     the embryo with the highest implantation potential. These parameters will be correlated with     (1) data of the fresh embryos and their subsequent survival, the evolution of the contact     surfaces between surviving blastomeres and the resumption of mitosis; (2) patient     characteristics and clinical outcome of frozen-thawed embryos and (3) a comparison between     embryos cryopreserved with vitrification or the slow method regarding these parameters will     be performed.      This project aims to introduce new evaluation criteria of the frozen-thawed embryos to     improve success rate of FET cycles. By establishing new precise, reliable and non-invasive     measurable parameters, we aim to (1) select which supernumerary embryos are at chance to     survive the freezing/thawing procedures, (2) establish cut off parameters for the survival     rate of the embryo, (3) assess implantation, pregnancy and live birth rates depending on the     developmental characteristics after thawing and after 24h of culture.      Our strategy for improving the outcome of FET cycles is based on the study of morphometric     and morphokinetic parameters in frozen-thawed embryos and the correlation with embryological,     clinical and cycle parameters. Transferring a well-defined thawed embryo with a high     implantation potential may lead towards an increase in the implantation and life birth rate     and an increase in the cumulative live birth rate with a reduction of the IVF costs in order     to optimize the health-economic situation of reproductive medicine.   "
49352|NCT02639702|"     Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics;     for example, it is recommended that agents with a short plasma half-life be administered     multiple times per day. However, to date, several randomized controlled trials (RCTs) have     shown no differences in clinical outcomes between once- and twice-daily dosing of various     antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option     regardless of plasma half-life. This would apply to clozapine as well; however, there have     been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of     efficacy and tolerability. To address this gap in the literature, the investigators shall     conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to     once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine     twice a day.   "
49353|NCT02639689|"     Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device     in deficits levator foot of central origin.   "
49355|NCT02639663|"     Leboride is a dental support device that was developed for reducing pain during active labor.     It is made of an inert material, placed in the woman's mouth and does not disturb breathing,     talking, or any other activity expected during labor. It is a single-use device, each user     receives a new one.      This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that     improve women's breastfeeding experience, and increase breastfeeding rates.   "
49356|NCT02639650|"     This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin     as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.   "
49357|NCT02639637|"     The purpose of this study is to understand how dipeptidyl peptidase IV (DPP4) inhibition in     diabetics affects hemodynamic parameters and sympathetic activation in the setting of     increasing concentrations of neuropeptide Y, an endogenous peptide. The central hypothesis is     that DPP4 inhibition decreases degradation of neuropeptide Y, resulting in increased     vasoconstriction and sympathetic activation.   "
49455|NCT02638298|"     This is a study comparing two methods of dressing a post operative wound that are currently     in practice. One method is a traditional dry gauze dressing. The other method is using a     negative pressure dressing that provides gentle suction on the wound.      The investigators will attempt to determine how well the use of post-operative negative     pressure dressing reduces wound healing problems in patients who have surgery after radiation     for a sarcoma in the thigh or leg.   "
49358|NCT02639572|"     Siloss® (Azurebio, Madrid, Spain) is a synthetic and inorganic bone graft material and is     composed of a dicalcium phosphate anhydrous (monetite), hydroxyapatite (HA), and amorphous     silica and trace amounts of zinc. It is manufactured by a proprietary process avoiding high     temperatures. This results in a non-sintered material with a high specific surface area (65     m2/g) and high interconnected porosity (60%) that favour a high degree of interaction with     its biological surrounding. It is fully resorbable, being replaced by natural bone, thereby     avoiding the disadvantages of nonresorbable materials that interfere with normal processes of     bone remodelling. Siloss® is resorbed both by a dual process of slow dissolution of its     components and by active cellular remodelling. Controlled dissolution of Siloss® releases Ca,     P, Si and Zn that stimulate regeneration processes while larger pores are formed allowing     colonization of osteoclasts and osteoblasts involved in bone remodelling. It functions as a     bioactive temporary scaffold maintaining the desired volume while it promotes bone     regeneration and is being replaced by new vascularized bone. The alloplastic property of the     graft material avoids the risk of infection and adverse inflammatory reactions. Also,     resorption of Siloss® prevents possible adverse effects associated with long permanence of     low resorbable materials.      The aim of the present study is to clinically and radiographically evaluate the efficacy of     bone graft material (Siloss ®) in the treatment of intrabony defects.   "
49359|NCT02639559|"     Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling     and volunteer unrelated donors. Unfortunately, this process requires four to six days of     G-CSF injection and can be associated with side effects, most notably bone pain and rarely     splenic rupture. BL-8040 is given as a single SC injection, and collection of cells occurs on     the same day as BL-8040 administration. This study will evaluate the safety and efficacy of     this novel agent for hematopoietic progenitor cell mobilization and allogeneic     transplantation based on the following hypotheses:        -  Healthy HLA-matched donors receiving one injection of BL-8040 will mobilize sufficient          CD34+ cells (at least 2.0 x 10^6 CD34+ cells/kg recipient weight) following no more than          two leukapheresis collections to support a hematopoietic cell transplant.        -  The hematopoietic cells mobilized by SC BL-8040 will be functional and will result in          prompt and durable hematopoietic engraftment following transplantation into          HLA-identical siblings with advanced hematological malignancies using various          non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD          prophylaxis.        -  If these hypotheses 1 and 2 are confirmed after an interim safety analysis of the data,          then the study will continue and include recruitment of haploidentical donors.   "
49360|NCT02639546|"     This open-label, dose-escalation study is designed to evaluate the safety, tolerability,     pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult     participants with solid tumors with known or potential kinase pathway activation for which     standard therapy has proven to be ineffective or intolerable or for which no curative     standard-of-care treatment options exist. The study will be conducted in two stages: a     dose-escalation stage and an expansion stage at the recommended dose.   "
49361|NCT02639533|"     Fibromyalgia syndrome represents a spectrum disorder characterized by widespread chronic     pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models     explaining the causes of the disease have focused on the reduced pain inhibitory systems     activity, that allow low intensity stimuli to be processed easier, and that finally amplify     pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which     demonstrated to be effective reducing pain. Different studies in animals have shown that it     works reducing the liberation of neuronal messengers, which slow the conduction of pain     signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are     still few studies aiming to explain how it actually works in patients with fibromyalgia,     though.      A better understanding of the mechanisms by which Pregabalin reduces pain in patients with     fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus,     the investigators propose to study in real-time the electrical, vascular and hormonal     response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin.     The vascular response will be assessed using functional near infrared spectroscopy (fNIRS)     neuroimaging techniques. The electrical response will be assessed using Transcranial Magnetic     Stimulation (TMS). The hormonal response will be assessed in blood, measuring neurotrophins     (Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis Factor). These     responses will be studied in consideration of the patients' characteristics that will be     assessed using validated scales.      Taken into account the above considerations, a crossover, double-blinded randomized clinical     trial is proposed. In the investigators' study, patients and healthy volunteers will be asked     to visit the investigators' laboratory in three opportunities: one for a baseline assessment,     and the other two to test the effects of either Pregabalin 150 mg PO or Placebo. All     participants will eventually receive both, Pregabalin and Placebo. In each visit a brain     hemodynamic, electrical, hormonal and clinical evaluation will be performed.   "
49362|NCT02639520|"     To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic     treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by     the proportion of patients who received an additional antibiotic treatment for acute lower     uUTIs during the trial.   "
49363|NCT02639507|"     The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment     of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading     to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel     with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic     retinopathy is often treated with laser or injections of medicine in to the eye.   "
49364|NCT02639494|"     An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a     guide wire across a stenotic native aortic valve into the left ventricle.   "
49365|NCT02639481|"     Patients with acquired brain injury (ABI) often suffer from severe disorders of consciousness     (DOC), such as coma, unresponsive wakefulness syndrome (UWS), or minimally conscious state     (MCS). This study examines the effect, a novel robotic rehabilitation device (the Erigo®Pro     system) has on the recovery of consciousness of DOC patients. The device enables patients to     be verticalized very early during acute neurorehabilitation and includes robotic leg movement     training as well as functional electrical stimulation (FES) of leg nerves. Patients will be     randomly allocated to one of three treatment groups: (i) control group with standard     physiotherapy without the device, (ii) device treatment without FES, and (iii) device     treatment with FES. Time until recovery of consciousness, rehabilitation outcome, and amount     of complications will be the outcome variables.   "
49366|NCT02639468|"     Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when     compared to reference measurements performed via right heart thermodilution   "
49367|NCT02639455|"     Poor oral health can greatly impact quality of life and can also impact overall health. For     instance, research suggests that poor oral health may be associated with systemic diseases     such as diabetes, heart disease, and stroke. Therefore, there is a need to investigate the     causes of poor oral health.      The idea that athletes may have a propensity for dental caries has been gaining traction.     There have been recent reports of high levels of dental caries, dental erosion and     periodontal diseases among elite soccer players compared to the general public and in     athletes from a wide range of sports. However, to date, no studies have investigated the oral     microbiome of athletes.      Many factors affect the development of dental caries, including host factors, diet, and the     microorganisms present in the oral cavity. More than 700 types of bacterial species have been     detected in the oral cavity, and some have been identified to play a significant role in the     development of oral disease. Streptococcus mutans is the main species involved in dental     decay with various lactobacilli also involved in the disease process. Treponema denticola,     Porphyromonas ginigivalis, and Aggregatibacter actinomycetemcomitans are the main species     involved in periodontal disease. It is not currently known if changes in the collective oral     microbiome foster or impede the development of these pathogens.      Complex microbe-host interactions occur to allow for the progression of oral disease, with     host nutrition and hygiene playing a significant role. Endurance athletes widely consume a     variety of sport drinks, gels, and energy bars for supplementation of electrolytes and     carbohydrates. The consumption of these foods leads to pH drops in the oral cavity and may     contribute to tooth erosion and demineralization. Oral disease may also be exacerbated by the     fluid and electrolyte deficit that impedes saliva flow during exercise. However, several     studies have failed to demonstrate a clear link between sports drinks and an increased risk     of dental caries among athletes.      Dental caries are caused by microorganisms in the oral cavity. These microbes may be affected     by host factors or nutrition in the progression of oral disease. Due to the documented     prevalence of dental caries in athletes and the lack of clear connection between sports     drinks and dental caries, the investigators propose to investigate any correlation that may     exist between exercise and the oral microbiome.   "
49368|NCT02639442|"     The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to     treat Lower Urinary Tract Symptoms (LUTS) due to BPH.      During the procedure an implant is delivered into the prostate tissue obstructing the urethra     and restricting urine flow. The delivery system uses an electro-cutting blade to perform a     circular and superficial incision, in which the implant is placed. Such an implant, with the     shape of an open ring, expands the obstructed area, reducing the fluid obstruction through     the prostatic urethra.   "
49369|NCT02639429|"     Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts     to require induction of labor because of increased rates of obstetric complications including     pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies     have shown that obese women experience increased labor duration and oxytocin needs when     compared to normal-weight women. This in turn results in increased rates for unplanned     cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and     non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of     obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix     (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol     will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.   "
49370|NCT02639416|"     Children with complicated severe acute malnutrition (SAM), such as inability to take adequate     feeds, infection and diarrhoea, require in-patient management. Despite following a     well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality     often exceeds 20%. Amongst survivors discharged home, many subsequently die, have long-term     poor growth or recurrence of SAM.      It has long been recognized that children with SAM have intestinal inflammation and that this     persists despite management according to WHO guidelines. The inflammation is thought to     result from increased exposure to microbial pathogens in the gut in areas with poor     sanitation. The damaged lining of the intestine impairs food digestion and absorption, likely     allows gut bacteria to enter the blood stream to cause sepsis and also exposes the gut immune     cells to microbial and food antigens causing the inflammation to persist. Failure to treat     the intestinal inflammation is likely to contribute to the poor response to treatment and     poor long-term outcomes in many children with SAM.      The intestinal inflammation seen in SAM is very similar to that which occurs in food     intolerance (e.g. intolerance to cow's milk protein) and inflammatory bowel disease. In these     conditions, the inflammation is treated very effectively with hypoallergenic (elemental)     and anti-inflammatory (polymeric) formulas. These are nutritionally complete feeds that     have a similar composition to the feeds used for nutritional rehabilitation in SAM.      We aim to undertake a pilot study to see if an elemental and/or polymeric formula are     tolerated by children with SAM and help to reduce intestinal inflammation. We also aim to     learn more about the intestinal inflammation in general that occurs in SAM by observing     carefully the effect of these specific formulae and to do in-depth metabolic analyses.   "
49371|NCT02639403|"     Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal     carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have     been published more than two decades ago and were based on 2D conventional RT, which is     nowadays no longer used. Consequently, prospective studies on the efficacy of 3D-RT in the     management of symptomatic rectal cancer are still lacking. The aim of this prospective study     was to assess the efficacy of palliative short-course 3D RT (SCRT) in patients with     symptomatic obstructive rectal cancer.   "
49372|NCT02639390|"     The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm     function after stroke. The investigators previously developed a novel training protocol that     combined the ARMin and HandSOME exoskeletons. This is one of only a few arm exoskeletons that     allow coordinated whole limb training in reach and grasp tasks with both virtual and real     objects. However, the robot has a very large inertia and friction, and only gross grasp     patterns are available. In development work, the investigators will significantly modify the     AMRin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of     retraining a wide range of functional activities. In the subsequent testing phase, a clinical     trial will examine the effects of robotic training in chronic stroke subjects.   "
49373|NCT02639377|"     The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a     chemical adjuvant for the treatment of peri-implant mucositis in single implants compared     with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month     follow-up.   "
49374|NCT02639364|"     The aim of this study is to assess the effects and safety of the early application of     BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and     adequate PEEP level in ARDS patients .   "
49375|NCT02639351|"     Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium     Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults     (18-45 years of age).   "
49376|NCT02639338|"     This study will evaluate the efficacy, safety, and tolerability of treatment with     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks     and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in adults with     chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis who have not previously     received treatment with direct-acting antiviral (DAA) therapy.   "
49449|NCT02638376|"     The objectives of this study are to evaluate the safety of and efficacy of the KXL system     with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes     having:        1. Keratoconus (KC) ,        2. Post LASIK ectasia (PLEc)   "
49377|NCT02639325|"     Background:      Some people with brain tumors have seizures related to the tumor. This is called     tumor-related epilepsy. Usually brain tumors are treated by removing as much of the brain     tumor as possible without causing problems. Researchers think this may improve the outcome     for people with brain tumors. It may completely relieve or greatly reduce the number of     seizures they have.      Objectives:      To evaluate people with brain tumors that are associated with seizures and to offer surgical     treatment. Also, to study how surgery affects seizures.      Eligibility:      People age 8 and older who have a brain tumor with associated seizures. They must be willing     to have brain surgery to treat their epilepsy.      Design:      Participants will be screened with a review of their medical records.      Participants will have a medical history and physical exam.      Participants will be admitted to the hospital at NIH. They will have      Medical history      Physical exam      Neurological exam      Tests of memory, attention, and thinking      Questions about their symptoms and quality of life      Blood drawn      They may also have:      MRI or CT scan. They will lie on a table that slides in and out of a machine that takes     pictures. For part of the MRI, they will get a dye through an intravenous (IV) catheter.      Video electroencephalography monitoring. Electrodes will be placed on the scalp. The     participant s brain waves will be recorded while doing normal activities. Participants will     be videotaped.      Participants will keep a seizure diary before and after surgery.      Participants will have surgery to remove their brain tumor and the brain area where their     seizures start.      They will stay in the hospital up to a week after surgery.      Participants have for follow-up visits at NIH.   "
49378|NCT02639312|"     Background:      Some head and facial abnormalities are rare and present at birth. Others are more common, and     may not show up until puberty. These conditions have different causes and characteristics.     Researchers want to learn more about these conditions by comparing people with face, head,     and neck abnormalities to family members and to healthy volunteers without such conditions.      Objectives:      To learn more about abnormal development of the face, head, and neck. To determine their     genetic variants.      Eligibility:      People who have not had surgery for facial trauma:      People ages 2 and older with craniofacial abnormalities (may participate offsite)      Unaffected relatives ages 2 and older      Healthy volunteers ages 6 and older      Design:      Participants will be screened with medical history and physical exam focusing on head, face,     and neck      Participants may be followed for several years. Visits may require staying near the clinic     for a few days.      A visit is required for the following developmental stages, along with follow-up visits:      Age 2 6      Age 6 10      Age 11 17      Age 18 and older      Visits may include:      Medical history      Physical exam      Questionnaires      Oral exam      Blood and urine tests      Cheek swab: a cotton swab will be wiped across the inside of the cheek several times.      Cone beam CT scan (CBCT): x-rays create an image of the head, face, teeth, and neck.     Participants will      stand still or sit on a chair for about 20 minutes while the scanner rotates around the head.      Photos of the head and face      Offsite participants will provide:      Copies of medical and dental records      Leftover tissue samples from previous surgery      Blood sample or cheek swab   "
49379|NCT02639299|"     Background:      Malaria is a serious infection caused by a parasite. People get malaria when an infected     mosquito bites them. Malaria can cause major health and social problems in places were     malaria is common, such as Africa but can also affect travelers who have never been exposed     to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine,     antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under     a general screening study in order to see if are qualified to join a future malaria study.      Objective:      To screen healthy volunteers to see if they are eligible to join investigational malaria     studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines,     or prevention regimens. They may also involve controlled human malaria infection trials.      Eligibility:      Healthy people ages 18 50      Design:      Participants will first be prescreened by phone.      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Participants may go more than 1 year without joining a clinical trial. If this happens, they     may be re-contacted to see if they still want to be part of this screening protocol. Those     who still want to participate and have had relevant medical changes will be rescreened.   "
49380|NCT02639286|"     Background:      Partial lipodystrophy is a deficiency of body fat in parts of the body (usually the arms and     legs). People with partial lipodystrophy often get high blood triglyceride (fat) level,     insulin resistance, diabetes and other problems. Researchers think the new drug ISIS 304801     can help treat health problems caused by partial lipodystrophy.      Objective:      To see if ISIS 304801 will improve blood fat (triglyceride levels), diabetes, and liver     disease, and reduce some risks for heart disease caused by partial lipodystrophy.      Eligibility:      Adults at least 18 years old with partial lipodystrophy.      Design:      Participants will be screened during a 1-week stay at NIH. They will have:      Blood and urine tests      Physical exam.      Assignment to get either the study drug or placebo.      Instructions for how to inject the drug.      Body measurements.      Heart tests.      Participants will give themselves injections of the drug or placebo once a week at home. Some     may test blood sugar by finger pricks. They will have monthly phone calls and nurse visits to     take blood tests.      After 4 months, participants may continue the study for 1 year. All participants will get the     study drug.      Participants will have study visits at NIH every 4 months. These may include:      Insulin sensitivity measurement: Insulin and sugar will be infused through 2 intravenous (IV)     lines in the arms. Blood will be drawn.      Sugar and fat metabolism measured by IV infusions and blood tests.      Special x-ray scan to measure body fat.      Liquid meal then blood collected by IV catheter in the arm.      Magnetic resonance imaging scans.      Neck ultrasound.      Questionnaires.      Liver biopsy (optional)      Injection of heparin (a blood thinner) before a blood test.      After finishing the drug, participants will have 1 nurse visit and 1 visit to NIH.   "
49389|NCT02639169|"     ABSTRACT The transplant allogeneic hematopoietic stem cell transplantation (HSCT Alo) is a     therapeutic medical treatment carried out in combat various neoplastic hematologic disorders,     congenital, genetic or acquired. In this procedure, which combines high-dose chemotherapy and     or radiation and has a degree of high cytotoxicity, the patient goes for a social solitary     confinement, which causes psychological distress, pain, anxiety, mood disorders and can lead     to depression. The music therapy was applied and the purpose of decreasing the insulation.     This is a randomized controlled study.      Method: Apply the intervention of live music sessions through the techniques of music     therapy; assess and quantify through the visual analog scale (VAS) and numeric. The dependent     variables, pain, anxiety and mood of the participants selected randomly for the experimental     group music therapy (EGM) n=50, and compare with the control group (CG) n=50, which received     only the standard treatment.   "
49390|NCT02639156|"     To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary     oral nutritional support compared with currently available alternatives.   "
49381|NCT02639273|"     Background:      Drugs like nalmefene interfere with opioid receptors. This might reduce drinking. The gene     OPRM1 determines opioid receptor functions. Researchers want to see if nalmefene affects     people s responses to alcohol cues. They also want to compare how nalmefene affects people     with different forms of OPRM1.      Objectives:      To test nalmefene s effects on alcohol self-infusion and responses to alcohol cues. To test     the role of different forms of OPRM1 on these effects.      Eligibility:      Healthy heavy drinkers ages 21 60:      Women: over 15 drinks weekly      Men: over 20 drinks weekly      Design:      Participants will be screened with:      Medical history      Physical exam      Heart, blood, and urine tests      Questionnaires      Participants will have three 10-hour visits and one 2-hour follow-up visit. They will take a     taxi. Visits are about 1 week apart.      Before visits, participants cannot drink alcohol for 1 day or take medicine for 3 days.      All study visits:      Questionnaires      Heart monitor      Two-hour alcohol session: A needle guides a thin plastic tube into a vein in each arm. One     tube receives alcohol. The other draws blood. Participants give themselves alcohol by     pressing a button on a computer.      Relaxing at the center until breath alcohol falls below 0.02 percent, or for 3 hours.      Visits 2 and 3:      Swallowing nalmefene or placebo.      One-hour brain MRI: Participants lie on a table with a coil on their head. They press buttons     in response to computer cues.      Follow-up visit: participants will discuss their drinking habits.   "
49382|NCT02639260|"     Three kidney diseases that affect both children and adults are minimal change disease (MCD),     focal segmental glomerulosclerosis (FSGS) and membranous nephropathy (MN). These diseases are     characterized by proteinuria (protein in the urine) and in the cases of FSGS and membranous     nephropathy, a tendency to progressive scarring of the glomerulus (the filtering units of the     kidneys) that leads to end-stage kidney disease. Several therapies are available for these     diseases, but these therapies do not provide lasting reduction in proteinuria for many     subjects. In the current study, carried out at the NIH Clinical Center, we are testing a new     therapy, ManNAc. ManNAc is a naturally occurring uncharged sugar that cells use to produce     negatively charged sialic acid. Kidney cells attach sugars such as sialic acids to proteins     and lipids (resulting in glycans), and these assist in cell function. Mouse models of the     inherited muscle disease GNE myopathy, which is due to sialic acid deficiency on muscle     glycans, responded favorably to oral ManNAc therapy and a clinical trial of ManNAc is ongoing     in GNE myopathy subjects. There is evidence that some subjects with MCD, FSGS or MN do not     put enough sialic acids on glomerular proteins and so ManNAc therapy may increase sialic acid     production and sialylation of glomerular proteins in these subjects. For the present study,     we will recruit 12 subjects who have MCD, FSGS or MN. Each subject will stay at the NIH     Clinical Center for 11 days to receive oral ManNAc. The primary purposes of the study are to     determine: 1) the safety of ManNAc in subject s with kidney disease; and 2) the ManNAc and     sialic acid metabolism related to ManNAc in subjects with kidney disease. Concentrations of     ManNAc and sialic acid will be measured in plasma at various times before and after dosing.     If this study suggests that ManNAc is safe in subject with kidney disease, the results will     be used to plan a longer-term study to determine whether it is effective at reducing     proteinuria.   "
49383|NCT02639247|"     This study will evaluate the efficacy, safety, and tolerability of treatment with     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks     and of sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in direct-acting antiviral     (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without     cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the     HCV NS5A protein.   "
49384|NCT02639234|"     This is an open label phase 2 study to evaluate the combination of Vigil™ and nivolumab in     advanced or metastatic NSCLC that is progressive on or after one prior platinum-based     systemic therapy. Patients meeting study eligibility criteria will receive Vigil™ every 2     weeks (for a minimum of 4 and a maximum of 12 doses) and nivolumab every 2 weeks. The     combination of Vigil™ and nivolumab will demonstrate a higher objective response rate (ORR)     than the historical ORR of single agent nivolumab in patients with advanced NSCLC.   "
49385|NCT02639221|"     The principal aim of this study is to obtain safety and tolerability data when PXT002331 is     administered orally as single and multiple doses to healthy subjects.   "
49386|NCT02639208|"     The number of patients 60 and older with breast cancer is increasing as our population ages.     Despite the fact that the majority of breast cancers occur in patients 60 and over, these     patients are consistently under-represented in clinical trials. Because patients 60 and older     are an under-studied group, investigators do not have detailed information on the side     effects and experiences for these patients receiving chemotherapy. Understanding the side     effects patients receiving chemotherapy experience is an important part of this study.      In addition, past research has shown that having poor social support can affect quality of     life, mood, and outcomes for people with cancer. However, few studies in the past have     focused on improving the quality of life and support systems that patients have while they     receive treatment.      This research study is evaluating how engaging in an online support community may improve the     experience of older patients receiving chemotherapy.   "
49387|NCT02639195|"     This study has two segments the first is a chart and outcome assessment of patients treated     at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have     completed multiple questionnaires as a standard of care for outcome monitoring in the clinic     setting, no new data will be collected. The second segment is a prospective observational,     online questionnaire based study of subjects with a history of SBO not treated at CP. Data on     the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed     using the same questionnaire used as standard of care in the clinic twice, 90 days apart.     This will be accomplished using the NIH Assessment Center, with subjects able to complete the     questionnaires with ease via the internet. As this segment is observational, there is minimal     risk to these subjects. The data obtained from the untreated subjects will allow for     reporting of overall impact on QOL in this population, data that is not available, as well as     provide a control group for assessment of improvement for interventions for SBO.   "
49388|NCT02639182|"     The purpose of this study is to evaluate the progression free survival (PFS), based on     investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic     renal cell carcinoma.   "
49391|NCT02639143|"     This is a prospective, randomized, parallel design study to investigate that ticagrelor could     attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation myocardial     infarction (STEMI) patients. The anticipated duration of the study is approximately 9 months,     including an anticipated enrolment period of 8 months and follow-up period of 1 month.     Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to     receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the     extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed     as number of total inflammatory cells per mm2 thrombus area.   "
49393|NCT02639117|"     This is a Phase 1 single site study to evaluate the safety and efficacy of a combination     therapy that includes the administration of vismodegib and photodynamic therapy (PDT) using     aminolevulinic acid (20 percent ALA) for multiple basal cell carcinomas. All subjects will     receive vismodegib 150mg by mouth every day for 3 months, and undergo three PDT sessions with     topical application of ALA. The PDT will be first administered at 7+ 4 business days after     the beginning of the Erivedge and at 45 + 5 business days and then at 90 + 10 business days.      Primary Objective The primary objective of this study is to determine the safety of     photodynamic therapy (PDT) with vismodegib (combination therapy) for patients with multiple     BCC.      3.2 Secondary Objective To evaluate the overall response rate (ORR) to the combination     therapy in patients with multiple BCCs.ORR is defined as the proportion of evaluable study     subjects who has complete or partial response to the study treatment.   "
49394|NCT02639104|"     This study investigates one of the mechanism factors of neck pain. Cervical lordotic angle     alterations affect the tension of serratus anterior muscle. Expected result that the long     thoracic nerve can be affected in this situation, and could be observed the functional     changes of the nerve with serratus anterior electromyographic findings.   "
49396|NCT02639078|"     Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of TD-0714 in healthy subjects.   "
49397|NCT02639065|"     This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable     patients will be enrolled. If total number of patients free of disease relapse at 1 year is     less than or equal to 15, the drug would not be considered for further study in this setting.     After six patients are treated with at least one dose of study drug, they will be observed     for a minimum of 60 days. During the 60-day observation period, further accrual will be     halted to evaluate unacceptable toxicities warranting early closure of the trial defined     as:        -  Any definitive durvalumab-related death. A durvalumab-related death will be continuously          monitored throughout the trial and the trial will be suspended for re-evaluation          whenever such an event is confirmed.        -  Any unexpected and previously unreported grade 4 toxicities definitely related to          durvalumab.   "
49398|NCT02639052|"     The purpose of this study is to determine if Botox is effective in the treatment of an     experimentally induced itch that mimics chronic itch in healthy volunteers.   "
49399|NCT02639039|"     The purpose of this study is to determine if trigger point dry needling (TDN) is as effective     as cortisone injection (CI) in reducing pain and improving function in patients with greater     trochanteric pain syndrome (GTPS).   "
49400|NCT02639026|"     The main purpose of this study is to determine how best to combine hypofractionated     radiotherapy, MEDI4736, and tremelimumab and to determine how safe and tolerable     hypofractionated radiotherapy, MEDI4736, and tremelimumab are when given together in subjects     with metastatic, melanoma, non small cell lung cancer (NSCLC), breast cancer, and pancreatic     cancer.   "
49401|NCT02639013|"     Early detection of intra-abdominal hypertension is essential to the prevention of abdominal     compartment syndrome and requires close surveillance of intra-abdominal hypertension in     patients at increased risk. intra-abdominal hypertension measurements are often taken by the     bedside nurse, and in some cases, initiation of serial intra-abdominal hypertension     monitoring is prompted by critical care nurses.   "
49402|NCT02639000|"     Single center randomized study including 388 women aged less than 39 years, performing in     vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs)     improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.   "
49403|NCT02638987|"     An experimental study will be conducted to evaluate the effect of a single dry needling     session on surface EMG activity (primary outcome measure), muscle tone, elasticity, stiffness     and pain (secondary outcome measures) of the upper trapezius, in female office workers with     trapezius myalgia.   "
49404|NCT02638974|"     Women prisoners are more likely to commit suicide or self-harm than women in the community or     male prisoners.      Healthcare services have improved how they manage self-harm in the community and prisons.     However, there has been little focus on the recovery of people with self-harm scars. Medical     skin camouflage (MSC) is a British National Formulary-listed topical cream designed to cover     skin conditions. Research on MSC has focused on its use with non-self-harm marks e.g. burns.     The evidence from this research suggests that the cream helps women feel better and do more     activities. There is little/no evidence about the effects of the preparation for women who     self-harm and for prisoners.      This research was funded by the National Institute for Health Research Research for Patient     Benefit Programme. In the research the investigators will examine whether it is possible and     practical to use MSC in prison. The investigators will ask women prisoners and staff what     they think about the cream. The research has four parts. In the first part the investigators     will run focus groups with women prisoners and prison staff to find out the best way to     deliver the MSC intervention and how to measure its effects. In the second part the     investigators will design a programme for delivering the MSC. The investigators will then     train 6-10 long-term prisoners to become skin camouflage practitioners. The final part will     involve a small randomised controlled trial with 40 women prisoners; 20 will be allocated to     the intervention group and will use the MSC for 6 weeks. The investigators will measure their     mood, thoughts of self-harm and wellbeing before and after they use MSC. The investigators     will compare these results with 20 women who have not used MSC (waitlist control group). All     women taking part will be placed at random into the control or the treatment group. The     control group will receive the MSC after the research has ended.      Potential benefits of this study may be an increase in self-esteem and quality of life for     the women prisoners. As women recover they may be less likely to self-harm.   "
49405|NCT02638961|"     Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent     form of HF in developed countries. Despite its increasing in prevalence, there is no     evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether     inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of     both improve exercise capacity as well as left ventricular diastolic function, biomarkers'     profile, quality of life (QoL) and prognosis in patients with HFpEF.   "
49450|NCT02638363|"     The aim of this study is to investigate the predictive value of emotion regulation and     attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety     disorders in a naturalistic setting.   "
49471|NCT02638090|"     The main purpose of this study is to see whether the combination of two drugs called     pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want     to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This     study will compare the effects of the combination of two drugs called pembrolizumab and     vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration     (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and     lung cancer and vorinostat to treat some forms of blood and lymph node cancers.   "
49408|NCT02638922|"     Objective      To evaluate the phenotypic characteristics and diagnoses in a large cohort of 304 consecutive     girls referred due to tall stature. Furthermore, to evaluate the effect of oral     administration of 17β-estradiol on predicted adult height in constitutionally tall statured     girls.      Design      A single-centre retrospective observational study of 304 girls evaluated due to tall stature     between 1993 and 2013.      Setting      Tertiary referral centre for pediatric endocrinology.      Participants      A total of 304 girls were evaluated for tall stature of whom 39 (13%) were excluded due to     missing data, reclassification, overgrowth syndromes or associated comorbidities. Another 58     (19%) girls did not fulfil auxological criteria for constitutionally tall stature (CTS),     resulting in a total of 207 (68%) girls eligible for analysis.      Main Outcome Measures      The effect of oral treatment with 17β-estradiol on height, predicted adult height (PAH),     final height and circulating hormones in constitutional tall statured girls.   "
49409|NCT02638909|"     The available data indicate that Ceritinib has substantial anti-tumor activity in patients     with anaplastic lymphoma kinase (ALK) and ROS1 rearranged non-small cell lung cancer (NSCLC).     This trial will investigate the potential of Ceritinib in patients with advanced     gastrointestinal malignancies with ALK and ROA1 rearrangement, and for whom there is no     available therapeutic option.   "
49410|NCT02638896|"     The primary objective of this study is to evaluate the efficacy of safety of etanercept dose     reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have     achieved a significant clinical response.   "
49411|NCT02638870|"     Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain     and disordered defecation and is one of the most common gastrointestinal problems. In     practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent     abdominal pain without an organic cause. Visceral hypersensitivity is the major contributing     factor of abdominal pain in IBS. Accordingly, tricyclic antidepressants (TCAs) are widely     used for IBS, especially if abdominal pain is a prominent symptom. Indeed, meta-analysis also     exhibits the clinically significant efficacy of low dose TCAs in IBS. Nevertheless, over 40%     of IBS patients receiving TCAs had no improvement in symptoms after treatment. Theoretically,     if TCAs are used for IBS patients with hypersensitivity, its efficacy could be increased.      Although rectal distension test might be used to identify hypersensitive patients with IBS,     it has been used only for clinical research because it is painful for the patient. On the     contrary, colonoscopy is frequently performed in IBS patients to rule out organic disease and     for the purpose of colorectal cancer screening. In a study by Kim and colleagues, IBS     patients reported higher pain score after colonoscopy than non-IBS patients. This has     prompted the hypothesis that pain scoring during/after colonoscopy could also segregate IBS     patients with visceral hypersensitivity showing better treatment response of TCA than those     without.      The aims of the present study were to evaluate the colonoscopy-related pain perception and     the treatment response of amitriptyline in IBS patients and to investigate the predictive     values of the colonoscopy-related pain scale in identifying IBS patients with a response to     amitriptyline treatment.   "
49412|NCT02638857|"     Objectives:      The purpose of this study is to evaluate the safety and efficacy of dendritic cell-precision     multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of     hepatocellular carcinoma.      Methods： This study designs a novel therapy using dendritic cell-precision multiple antigen T     cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial     chemoembolization group and dendritic cell-precision multiple antigen T cells combined with     transcatheter arterial chemoembolization group. Treatments will be performed every 3 weeks     with a total of three periods. The mail clinical indicators are Progression-Free-Survival and     Overall Survival.   "
49413|NCT02638844|"     Assessment of right ventricular (RV) function in patients with acute respiratory syndrome     (ARDS) is warranted because RV failure is frequent and associated with worse outcome.     Transthoracic echocardiography is the cornerstone of RV assessment but it remains     challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography     (STE) is a widely available and reproducible technique that readily provides an integrated     analysis of all segments of the RV. This study aims to investigate the accuracy of     STE-derived strain parameters in assessing RV function during ARDS.   "
49414|NCT02638831|"     Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with     Gonarthrosis and Low back pain.   "
49415|NCT02638818|"     The purpose of this study is to evaluate the impact of the quality of life in patients     undergoing the Whipple procedure (pancreaticoduodenectomy, PD) for pancreatic cancer. The     Whipple procedure can be done by laparoscopic (small incisions) or an open procedure (large     incision) to treat the patients cancer. The goal of this study is to see if there is any     difference in quality of life between patients who undergo the laparoscopic or the open     Whipple procedure. Surgical technique (minimally invasive versus open) will be at the     discretion of the operating surgeon. Patients will not be randomized to a treatment arm.      A subset of these patients will also be asked to take part in a pre- and postoperative     in-depth interview to explore the lived experiences of patients with resectable pancreatic     cancer.   "
49416|NCT02638805|"     A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in     subjects with Type 2 diabetes taking liraglutide and metformin.   "
49417|NCT02638792|"     The purpose of this study is to examine if an internet-based exposure therapy is more     effective in reducing excessive worry amongst patients who suffer from this problem than is     internet-based stress management training.   "
49451|NCT02638350|"     The main objective is to assess the validation of the diagnosis early acute pulmonary edema     in elderly patients with acute respiratory distress, admitted in a host of vital emergency     services by lung ultrasound associated with the measurement of the inferior vena cava.   "
49453|NCT02638324|"     The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart     failure patients. The present study is planned to reduce the sympathetic tone in patients     with severe heart failure by renal nervous denervation.   "
49487|NCT02637882|"     The patients will exposed to different intervention through three nights (ear plug, eye     mask). 50 patients in the age range 18- 60 years admitted to ICU of Assiut university     hospitals will be randomly allocated into into two groups (control group and intervention     group).   "
49418|NCT02638779|"     The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine     storm, that participates to occurrence of organ failures and early death, followed by a     compensatory anti-inflammatory response leading to immunosuppression, is now well     established. This immunomodulating response results in a higher risk of secondary infections     and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune     status with time is crucial to guide therapy management. Objective of REALISM project is to     demonstrate existence of this immunosuppression phase, by providing strong epidemiologic data     for septic shock patients, but also by extension to other situations of inflammatory     aggressions like severe severe trauma or burns, or major surgery. This project will provide     tools to predict occurrence of secondary infections and guide patient management by comparing     innovating immunomonitoring tools to reference tests non already adapted to a routine patient     management.      Targeted populations are adult patients hospitalized for septic shock, severe trauma     (including severe burn) or major surgery and healthy volunteers, whom blood samples will     serve to validate reference intervals of the two reference tests.   "
49419|NCT02638766|"     Evaluate the treatment with regorafenib in patients with metastatic and/or unresectable     KIT/PDGFR wild type GIST in the first line setting.   "
49420|NCT02638753|"     Although education on neurophysiology of pain improves disability, there are limited effects     in pain intensity. Hypnosis is an approach that has proven useful in pain intensity and     psychosocial aspects in some chronic pain conditions, but there is insufficient evidence of     its contribution in patients with chronic non specific low back pain. The aim of the study is     to assess the efficacy of combining education on neurophysiology of pain and hypnosis in     patients with chronic non specific low back pain in pain and disability outcomes.   "
49421|NCT02638740|"     Periodontal disease is a chronic inflammatory process accompanied by destruction of     Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially     in developing and underdeveloped countries affecting more than 80% population.     Epidemiological studies have shown that about 10% of the adult population suffer from severe     periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion     is not strictly a localized process but may lead to systemic alterations in immune system.     Various studies confirm the microbial etiology of periodontal disease.   "
49422|NCT02638727|"     The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial     function and vasodilation in patients with coronary artery disease(CAD) by evaluating the     brachial artery diameter in the antecubital area by ultrasonography.   "
49423|NCT02638714|"     A single arm, single center trial to assess the safety and efficacy of restoring function in     damaged optic nerves using autologous purified populations of bone-marrow derived stem cells     (BM-SCs) through a 24 month follow up period.   "
49424|NCT02638701|"     Patients harboring dolichoectactic vertebrobasilar (DVB) aneurysms are at risk of suffering     SAH, ischemic stroke, and/or brainstem compression and many patients are not offered invasive     treatment due to the futility of existing surgical methods. Consequently, there is demand for     development of medical therapy for DVB aneurysms   "
49425|NCT02638688|"     Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual     myomas volume after surgical removal, to clinically test the validity and usability of 3D     ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the     reliability of different ultrasound methods to measure volume of uterine fibroids.   "
49426|NCT02638675|"     The objective of this randomized control trial is to examine whether incentives-for-steps     (i.e. $1 per day step count goals are reached) increase daily step counts among physically     inactive hospital employees.   "
49427|NCT02638662|"     The effect of stress on IVF outcomes.   "
49428|NCT02638649|"     This is a pilot observational feasibility study of the ability of paramedics to assess     thoracic ultrasound findings in the prehospital environment. The primary goal of the study is     to determine whether paramedics are able to accurately assess for sonographic B-lines in     patients with undifferentiated shortness of breath at least 80% of the time in the     prehospital environment using a portable ultrasound (U/S) device.   "
49429|NCT02638636|"     The purpose of this study is to examine if an internet-based exposure therapy is effective in     reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.   "
49430|NCT02638623|"     The investigators are testing the hypothesis that administering 2L of body temperature warmed     lactated ringer's intravenously prior to surgery can optimize the postoperative and recovery     of patients undergoing total hip and total knee arthroplasty.   "
49431|NCT02638610|"     The aim of the study: Assessment of Changes of Periocular Skin Sensation Following Eyelid and     Ocular Surface Surgeries.      Study design: an interventional study that will be conducted at the ophthalmology department,     Meir hospital, Kfar Saba, Israel.      the study will include 60 healthy patients, at the ages of 40-80, which are candidates for     eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion repair.      The patients will be recruited from Meir's ophthalmology outpatient clinic. Each patient will     undergo a full ophthalmologic examination including relevant assessment of the specific     eyelid pathology.      The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet     filament-type aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take     place before surgery, and two weeks, three months and six months after surgery.   "
49432|NCT02638597|"     This project will test whether gemfibrozil, a well-studied medication for high cholesterol,     will help people stop smoking nicotine cigarette smoking. The study will also test whether     gemfibrozil decrease cravings for cigarette and the desire to smoke.   "
49433|NCT02638584|"     This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients     undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and     investigated Prevention of gastrointestinal bleeding.   "
49434|NCT02638571|"     The overall purpose of the study is to evaluate nutrition education interventions to promote     pulse incorporated complementary food to the wider rural community through the government     system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of     young children (6 to 24 months). The hypothesis is that nutrition education improves mothers     knowledge, attitude and practice of pulse incorporated complementary food and improves     dietary intake of iron and zinc and nutritional status of young children.   "
49435|NCT02638558|"     Split-dose cleansing regimens for colonoscopies, independently from the type of laxative     used, are now recommended over full (one day)-dose regimens from all the major guidelines. It     is wellknown that splitting the dose (half of the dose the night before and half the day of     the colonoscopy) is safe and guarantees a better cleansing of the colon and thus a higher     chance of identifying mucosal lesions. This is crucial both in terms of achieving a     high-quality colonoscopy and in terms of time and money saved.      Still, there are some issues about compliance and tolerability with split-dose regimens. Two     recent prospective works have shown that only a small number of patients (33%) chooses the     split-dose regimen when the colonoscopy is scheduled before 10 a.m. and when patients are     forced to used the split-dose, 1/7 did not comply with it, especially if the procedure is     before 10 a.m. The most common concerns are about early wake-up, travel interruption and fear     of incontinence. Both these papers state that strategies to reduce this noncompliance are     needed.      The investigators aim to prove whether an active action (an oral explanation before the     colonoscopy about why split-dose regimens are better) may improve patients' compliance in     endoscopies scheduled in the early morning (from 8 to 10 a.m).   "
49436|NCT02638545|"     The current treatment regimen of patients with septic shock requires a sufficient hemodynamic     support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive     fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral     resistance and preserve organ perfusion, a continuous infusion of catecholamines is often     needed. Because sepsis is usually associated with adrenergic receptor and post-receptor     abnormalities, the efficacy of such treatment regimens often gradually decreases over time,     thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists     increase pressor responsiveness following lipopolysaccharide administration. This study will     assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine     requirements in patients with septic shock.   "
49437|NCT02638532|"     The specific aim of this outcomes study is to assess if the volume of fat that is injected     into the foot is retained at 6 months, to determine the retention over time, and assess the     quality of the bone before and after treatment. We will also correlate adipose stem cell     characteristics to the fat retention over time.   "
49438|NCT02638519|"     This study involves imaging participants' brains using MRI. The goal is to develop a     high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain     magnetic resonance imaging, which can provide more sensitive measurement of brain function,     facilitating the development of drugs for more successful treatment of Alzheimer's disease.   "
49439|NCT02638506|"     Background : Headaches are a common presentation for children consulting to the Emergency     Department (ED). However, only few studies have evaluated the rapid pain improvement provided     by medications in the acute management of headaches in the pediatric population.      Objective : To evaluate pain reduction provided by intranasal fentanyl (INF) compared to     placebo in addition to ibuprofen for children presenting to a pediatric ED with moderate to     severe headaches.      Methods : A single-center, double-blind, randomized, placebo controlled clinical trial will     be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All     children eight to 18 years old who will present to the ED with headaches as a main chief     complaint and with pain of ≥ 36 mm out of 100 on Visual Analog Scale (VAS) will be recruited.     Study participants will be randomly allocated to receive INF 1.5 mcg/kg (maximum dose of 100     mcg) or similar volume of a placebo solution via an atomizer. Co-administration of oral     ibuprofen 10 mg/kg (maximum dose of 600 mg) will also be provided to the two groups if not     received in the previous 4 hours. The primary outcome will be the mean pain rating reduction     at 15 minutes. The secondary outcomes will be mean pain reduction at 30 and 60 minutes,     patient's and parental satisfaction levels, percent of being pain free, sedation score,     immediate and within 72 hours adverse events, additional ED analgesics and other medications,     length of ED stay, disposition outcomes, hospital admission rate and ED revisit rate within     72 hours. The primary analysis will use an intention-to-treat approach to compare mean pain     score reduction between the two groups using a Student's T-test. The sample size of 60     participants per arm was calculated to have a power of 80% to identify a difference of 10 mm     in the VAS.      Expected results : Our study might demonstrate that INF provides additional pain relief for     children presenting to an ED with headaches. Providing INF could relieve their symptoms more     quickly, potentially improve patient's and family's satisfaction, possibly reduce the length     of their ED stay and consequently, have a significant impact on patient quality of care and     cost-effectiveness.   "
49440|NCT02638493|"     Male participants taking tenofovir-emtricitabine (TDF/FTC) will provide semen and blood     samples which will be analyzed to better understand the pharmacology of antiretroviral     therapy in the male genital tract.   "
49441|NCT02638480|"     The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee     rehabilitation device on the incidence of postoperative flexion contracture.   "
49442|NCT02638467|"     Patients newly diagnosed with chronic phase chronic myeloid leukemia undergo treatment with     TK inhibitors (TKI). A possible cause of TK failure is represented by the insufficient     recovery of normal Ph- hematopoiesis during TKI treatment, with consequent severe cytopenias     that limit TKI adequate administration. Although rare, this event happens in a proportion of     4-5% of CML patients. Our hypothesis is to circumvent this peculiar condition by providing a     normal hematopoiesis from a HLA-matched donor (Human Leukocyte Antigen). The transplant     procedure is therefore intended in providing a sustained hematopoiesis that will allow an     early treatment with an adequate dosing of TKI. The transplant procedure planned in our study     is built on all available evidences to provide the lowest incidence of acute and chronic GvHD     (Graft-versus-host disease). Therefore, a bone marrow will be the preferential source and a     GvHD prophylaxis based on Anti-thrombocyte globulin (ATG) and Cyclosporine/Methotrexate will     be used according to standard current experience in the field of family and unrelated donors.     The pre-transplant TKI will be continued until aplasia will develop, in order to decrease the     tumor load as much as possible.The use of TKIs shortly after transplant carries the risk of     inhibiting the newly transplanted hematopoietic cells, as Kit, an important kinase in normal     bone marrow cells, is frequently blocked by Abl inhibitors. The use of bosutinib as     post-transplant therapy is justified by the lack of Kit inhibition that distinguishes     bosutinib from all other TKIs, and which could allow a minimal inhibitory activity against     the transplanted normal bone marrow.   "
49443|NCT02638454|"     Sarcopenia is a predictor of functional-limitation, leading to loss of independence, lowered     quality of life, and ultimately death. The impaired ability of aged skeletal muscle to adapt     to anabolic stimulation may be a factor that contributes to sarcopenia. This project will     provide novel insights into the role of microRNA in the attenuation of aging skeletal muscle     to changes in gene expression after anabolic stimulation.   "
49444|NCT02638441|"     The aim of this study is to determine the prevalence of psychological affection in infertile     egyptian women   "
49454|NCT02638311|"     Prospective multicenter sample collection and testing study.   "
49456|NCT02638285|"     To compare pregnancy rate by Human Chorionic Gonadotropin (HCG) administration and urinary     Luteinizing Hormone (LH) surge method for insemination in patients undergoing Intrauterine     Insemination (IUI) at Montaserieh infertility center.      The present study comprised 309 infertile women candidate for IUI, randomly divided into LH     surge and HCG groups (assign the number for each patient, odds number for LH and even number     for HCG group). All patients were subjected to baseline ultrasound and received clomiphene     citrate before undergoing serial transvaginal sonography. LH was measured using LH kit when     2-5 follicles (18-20 mm) appeared in LH surge group, and if positive, IUI was performed after     24 hours. In HCG group, the patients received HCG 1000 units and underwent IUI after 36     hours. The pregnancy rate was then compared in LH and HCG groups.   "
49457|NCT02638272|"     Whether radical debridement is necessary for the treatment of thoracic and lumbar     tuberculosis is still questionable. The objective of this prospective randomized study was to     compare the outcomes of radical debridement versus no debridement under different surgical     procedures for the treatment of thoracic and lumbar tuberculosis.   "
49458|NCT02638259|"     Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate     to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic     drugs (DMARD) including methotrexate (MTX).   "
49459|NCT02638246|"     Self-management of diabetes can result in long-term benefits, such as delaying or preventing     the development of a number of unnecessary health complications, and can even reduce the     chances of premature death. Because adherence to diabetes self-management often declines     during adolescence, it is critically important to develop interventions that increase     adherence of diabetes self-management skills in this population.   "
49460|NCT02638233|"     Patients with chronic hepatitis C that are under opiate substitution therapy are likely to     have psychiatric comorbidities such as depression; hence an Interferon based therapy is     contraindicated. Additionally many of these patients have a borderline compliance, which     makes it impossible to treat them at specialized hepatological centers. An ideal opportunity     to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be     administered daily together with the opiate substitution therapy at a low threshold facility.   "
49461|NCT02638220|"     This is an observational, multicenter study to determine the prevalence of Cerebrotendinous     Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral     cataracts. Patients who are potentially eligible for study participation will be identified     through a chart review of patients who were seen at each study site prior to that site's     initiation, or by entering care at the site while the site is participating in the trial.   "
49462|NCT02638207|"     Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients     With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy   "
49463|NCT02638194|"     The primary purpose of this study is to examine the health effects of mainstream and     secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well     as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that     inhalation of both mainstream and secondhand smoke generated by hookah produces adverse     pulmonary and cardiovascular effects and alterations in serum levels of inflammatory     biomarkers.   "
49464|NCT02638181|"     This study was to assess the distinct expression of matrix metalloproteinase 13,tissue     inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork     between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue     inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork     tissues were examined by streptavidin-peroxidase immunohistochemical staining method and     western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and     Eosin staining.   "
49465|NCT02638168|"     Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these     children have moderate to severe impairments in sleep, further exacerbating their already     impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed     sleep medications are antipsychotics that can cause marked weight gain and metabolic changes;     alternate medications have either been found to be ineffective, difficult to tolerate or are     largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms     of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive     behaviors could improve sleep patterns and this application will assess if the extension of     the therapeutic effects of CNS stimulants into the early evening improves sleep onset.   "
49466|NCT02638155|"     The purpose of this exploratory study is to use Electrogastrography (EGG) to measure and     compare the gastric myoelectrical activity between persons with food addiction (FA) and a     control group. Additionally, this study will explore if differences exist between perceived     hunger and satiety and hormone levels related to hunger and satiety in both groups. The     comparison of the EGG readings and hormone levels is the next step in furthering our     understanding of food addiction and how the physiology - not simply the symptomatology - of     FA does or does not relate to weight management.   "
49467|NCT02638142|"     DiurHF is a prospective, multicenter, observational, study that compares continuous with     intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous     pilot study design was planned to anticipate a larger multicenter trial able to definitively     evaluate the optimal loop diuretic use strategy in patients with ADHF.   "
49468|NCT02638129|"     The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone     hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo     and rule out excess risk of major adverse cardiovascular events (MACE) when given in     combination with standard of care in overweight and obese participants with documented     history of CV disease.   "
49469|NCT02638116|"     The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of     Ibrutinib in Healthy Adults.   "
49639|NCT02635906|"     This is a randomized clinical trial with a control group, based on the guidelines of the     CONSORT 2010. The interventional group will be in a bed rest for two hours after introducer     removal in patients submitted a coronary arteriography or coronary angioplasty and the     control group will follow the standard nursing care for four hours.   "
49472|NCT02638077|"     -  To find out the gap between real-world clinical practice and guideline recommendations          in initial management of DTC patients        -  To observe the characteristics of patients who achieved and did not achieve TSH target          value after one year follow-up        -  To assess response to initial therapy in patients who undergo total or near-total          thyroidectomy and RAI remnant ablation after one year follow-up (according to an          modified dynamic risk stratification system)        -  To observe the recurrence status after one year follow-up   "
49473|NCT02638064|"     Assessment of surgiflo injection for treating pilonidal sinus disease   "
49474|NCT02638051|"     This trial studies efficacy and safety of combination of modulated electro-hyperthermia     (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with     malignant ascites versus standard chemoinfusion (CDDP+5FU).   "
49475|NCT02638038|"     This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg     and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with     treatment-naïve RRMS for ≤ 3 years.   "
49476|NCT02638025|"     This study use anterior segment spectral-domain optical coherence tomography (SD-OCT) to exam     patients with closed globe injury, and compared with slit lamp examination. The results     showed that OCT can identify features of closed globe injury that were otherwise not visible     on slit lamp biomicroscopy.   "
49477|NCT02638012|"     Current management strategies for severe and recurrent epistaxis secondary to Hereditary     hemorrhagic telangiectasia (HHT) include surgical procedures, and uncomfortable nasal     packing, both of which are often only short-term solutions. Floseal® may provide a     non-invasive and less painful treatment option for epistaxis in HHT patients. This hemostatic     agent has been shown to be an effective intraoperative hemostatic agent in a number of     surgical procedures including endoscopic sinus surgery. It has also been shown to be     favorable over nasal packing at controlling acute anterior epistaxis. Though the efficacy of     using Floseal® for epistaxis in HHT patients has been proven anecdotally in the literature it     has yet to be proven in a prospective clinical trial. The results of this pilot study will     provide insight into the efficacy of using Floseal® in the management of severe epistaxis in     HHT patients and to assist in the development of a full-scale prospective clinical trial.   "
49478|NCT02637999|"     Randomized open-label substudy of daily Myrcludex B plus pegylated interferon-alpha-2a in     patients with HBeAg negative chronic hepatitis B co-infected with hepatitis delta   "
49479|NCT02637986|"     Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are     associated with several maternal and fetal complications, including maternal septic shock,     preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the     prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that     alterations in the vaginal flora were associated with recurrent UTIs, and probiotic     administrations may have a role in preventing those infections. Nevertheless, this has never     been tested in pregnant women.   "
49480|NCT02637973|"     The effects of empagliflozin treatment on hepatocellular lipid content, liver energy     metabolism and body composition will be investigated in a multicentre, prospective,     placebo-controlled, double-blind, randomized, 2-arm parallel, interventional and exploratory     pilot study in patients with newly diagnosed type 2 diabetes.   "
49481|NCT02637960|"     This study will investigate the efficacy and safety of fedovapagon in the treatment of     nocturia in men with BPH.   "
49482|NCT02637947|"     The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the     Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with     ischemic scar VT in a low ejection fraction population.   "
49483|NCT02637934|"     Up to 30 women with known or suspected epithelial ovarian, fallopian tube, or primary     peritoneal cancer will participate in two different imaging cohorts. The Biodistribution     cohort will include up to 10 patients and the Dynamic cohort will include up to 20 patients.     Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date     will evaluate preliminary information on uptake of [18F]FTT in gynecological cancer and     compare with PARP-1 activity in tissue.   "
49484|NCT02637921|"     Bone losses are well known to occur in response to unloading (in microgravity or during     immobilisation) and in patients with chronic obstructive airway disease (COPD). However, it     is unknown whether there is an interactive effect between hypoxia and musculoskeletal     unloading upon bone and mineral metabolism. Fourteen non-obese men, who are otherwise     healthy, will undergo 3x 21-day interventions; normobaric normoxic bed rest (NBR; FiO2=21%),     normobaric hypoxic ambulatory confinement (HAMB; FiO2=14%; ~4000 m simulated altitude), and     normobaric hypoxic bed rest (HBR; FiO2=14%). The effects of hypoxia and bedrest on bone     metabolism and phosphor-calcic homeostasis will be assessed (before and during each     intervention, and 14 days after each intervention period) using venous blood sampling, 24hr     urine collections, and peripheral quantitative computerized tomography (pQCT).   "
49485|NCT02637908|"     A training module has been developed for parents to effectively address stressors and demands     of parenting and promote positive and supportive parent-child interactions. The purpose of     this study is to implement the parent training program and evaluate the effectiveness of the     program. Depending on the results, investigators expect core aspects of this module to be     adaptable and modified or extended for parents of older children in the future to meet the     needs of families across the stages of childhood development.   "
49503|NCT02637674|"     Uterus transplantation may enable women with uterine factor infertility to become pregnant     and give birth.      This study will explore the feasibility of a uterine transplant and eight subjects will     undergo deceased donor uterine transplantation at CHU de Limoges.      There phases involved in this study: Primary, Secondary and Tertiary Screening, Medical     Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up.   "
49486|NCT02637895|"     Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a     traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after     treatment with antidepressants; however, few patients experience complete symptom relief.     There is a need to develop new treatments for PTSD.      This study will evaluate if 12 weeks of using Vortioxetine relieves PTSD symptoms.     Vortioxetine has been approved for the treatment of depression; however, Vortioxetine has not     been approved by the Food and Drug Administration for the treatment of PTSD.   "
49488|NCT02637869|"     The investigators are conducting a prospective analysis of the Alternative Payment     Methodology (APM) demonstration project sites. The investigators' goal is to conduct a cross     project analysis of findings. The investigators propose to use mixed methods to study     processes and outcomes associated with the APM natural experiment in payment reform. The     investigators hypothesize that Community Health Centers (CHCs) participating in the APM     demonstration project will redesign their workflows to better focus on patient and population     health needs, resulting in reallocation of financial resources, lower overall costs, changes     in utilization patterns, and improved quality.   "
49489|NCT02637856|"     This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who     have had a suboptimal response to an adequate course of DMT. Participants will receive     ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg     total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up     to 96 weeks). Anticipated time on study treatment is 96 weeks.   "
49490|NCT02637843|"     Coronary angiography (CAG) and possible angioplasty (Percutaneous Coronary Intervention =     PCI) can be performed by access from the groin (a. femoralis), the wrist (a. radialis) or the     elbow (a. brachialis). It is well established that there is less risk of bleeding     complications when using a radial access. The smaller diameters of the vessels in the     forearm, however, may result in increased risk of pain during CAG/PCI via a. radialis. This     is associated with vascular spasm (spasm tendency). Ultimately this means that one may have     to convert to access via a. femoralis.      To perform a CAG/PCI, a tube (a so-called sheath) has to be inserted in a. radialis. It is     unclear whether the design of the sheaths can reduce the spasm tendency, thus reducing pain.     Terumo has recently introduced a new kind of sheath, so-called Terumo Glide Slender Heath     Coated (hereafter referred to as Slender sheath). This sheath is partly coated, partly made     of a thinner material. Slender sheath thus has an outer diameter smaller than that of the     sheath from traditional use (Terumo Radio Focus sheath, hereafter referred to as Standard     sheath), although the inner diameter (lumen) is the same in the two sheaths. In turn, the     Slender sheath is more fragile and far more expensive.      The purpose of the present study is to evaluate whether use of slender sheath compared with     standard sheath is Associated with less pain and fewer complications following CAG/PCI.   "
49491|NCT02637830|"     This study mainly compared the response of the artificial carious enamel lesions to     remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel,     MHDP and Buffer solutions.      The lesions were then remineralised in an in situ model, with crossover and double blind     design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of     each demineralising protocol during 3 experimental phases (3 days each). The experimental     phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care (fluoride     dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F and     dentifrice- 1,100 ppm F, NaF).      During the 3-day phase, the appliance was only removed during the main meals (four times a     day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals,     before replacing the appliance in the mouth, the subjects were advised to perform oral     hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and     dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from     Crest Procter & Gamble, Cincinnati, OH, USA) according to the phase and dental floss     (Sanifill, São Paulo, Brazil).      The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the     first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of     solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects were     advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to     Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before     the in situ study for 6h and then removed.      The enamel remineralization was quantified using transverse microradiography (% mineral     recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were     submitted to statistical analysis (p<0.05).   "
49492|NCT02637817|"     As a common white matter (WM) disease in preterm neonates, punctate white matter lesion     (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and     auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it     is lack of certain methods in identifying the prognosis of PWML. Through using various     advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal     study would be conducted to follow-up the PWML neonates with varying spatial-position and     degree lesions. Through tracking the variations in WM microstructures from neonate period to     childhood (2 years old and 3 years old), this study aims to explore (1) the potential     relations between varying PWMLs and motor and visual disorders (2) the relations between WM     MRI-metrics and neurodevelopmental assessment results, and thus determine the early     biomarkers to identify CP and amblyopia.   "
49493|NCT02637804|"     Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A      This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study     (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses     compared to narafilcon A or delefilcon A spherical lenses.   "
49504|NCT02637661|"     The purpose of this study is to explore the earlobe crease as a risk factor of acute     myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to     predict high risk patients with coronary heart disease.   "
49635|NCT02635958|"     With, one in three Americans now having a body mass index (BMI) greater than 30, and the     fastest growing segment of the population having a BMI greater than 40, it is paramount to     conduct validation of approaches to measure body composition. Currently the dual-energy x-ray     absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is     often difficult to perform since it is limited to specific height, weight and BMI's. InBody     is a tool which uses bio electric impedance to measure the body composition. This study will     compare both approaches. Validation is necessary as it is clinically quite pertinent to     accurately assess a patients' body fat percentage, fat free mass, and total body water and     changes that are occurring with nutritional support.   "
49505|NCT02637648|"     The purpose of this study is to test the effects of sodium oxybate on headache response     (frequency), sleep quality and quality of life in the prophylactic treatment of patients with     chronic and episodic cluster headache. Oral sodium oxybate, 3-9g per night, starting with 3g     in two nightly dosages of 1.5g and increased by steps of 1.5g every second or third night     until treatment Response will be evaluated in an interventional, placebo-controlled,     double-blind, randomised, parallel group, multicentre study. Primary outcome is reduction of     nocturnal pain frequency Secondary outcomes are improvement of sleep quality at a subjective     level as assessed by diary and standardized scales (PSQI, FOSQ), duration of pain free     episodes, general clinical outcome (global evaluation), clinical global impression (CGI-S,     CGI-I, CGI-E), quality of life (SF 36) and daytime sleepiness (Epworth Sleepiness Score).   "
49494|NCT02637791|"     Stroke is the third most common cause of mortality and the leading cause of long term     disability worldwide with over 900,000 people living in England who have had a stroke. 75% of     survivors regain their ability to walk again, however it is estimated that between 55 and 75%     fail to regain satisfactory use of their impaired arm. This limits the person's independence,     ability to care for themselves and reduces their quality of life. Research indicates that for     optimal recovery, high levels of rehabilitation are required yet current provision often     fails to meet the required levels of intensity and duration of therapy.      In conjunction with stroke patients, their families and therapists, the team developed a low     cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at     home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers     turning the hand into a game controller to play games that encourage the movements of reach,     grasp and release that underlie activities of daily living.      Before examining its effectiveness, the purpose of the registered study is to determine how     feasible a large trial would be in terms of whether sufficient participants could be     recruited, whether they would use the glove and whether outcome measures could be collected.      Patients will be recruited if they are aged 18 years or over, are recovering from a stroke,     no longer receive any other intensive rehabilitation but still experiencing difficulty using     their arm. After baseline measures are collected they will be randomly allocated to either     the intervention group or a control group. The intervention group will have the virtual glove     and games at home for a period of eight weeks and be advised to use the equipment for 20     minutes, three times a day. The control group will continue to have whatever care they are     already receiving but no new interventions.      Outcome measures will be collected at baseline, four weeks and after the equipment has been     removed from their home. Outcome measures will include tests of arm function as well     participant reports of how often they are using their affected arm and how easy they find     activities of daily living. The therapists collecting the outcome measures will not know to     which group the participants have been allocated.      Once all outcome measures are collected the two groups will be compared on how much their     final outcome measures differ from those collected at baseline.   "
49495|NCT02637778|"     The interventional study will evaluate effectiveness and potential of a 'cardioprotective     diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective     diet' is characterized by adequate energy intake, intake of carbohydrates, protein and fat     according to the guidelines of the German Society of Nutrition (DGE e. V.), with special     focus on fat quality of the foods.      Half of the participants will consume additional n-3 long-chain (LC)-PUFA (3 g     eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/d). The study participants receive     defined personal nutritional counselling every two weeks and they get daily menu plans (with     optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).   "
49496|NCT02637765|"     This is a prospective randomized controlled trial in which patients with previous breast     cancer will be randomized into two treatment arms:        1. Control Group of Usual Physical Activity        2. Intervention Group of Increased Physical Activity      No specific intervention will be performed In the patients randomized in the control group.      Patients randomized in the Intervention group will receive a program of increased physical     activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time     patients of this group will receive an 8-week recreational program of brisk walking/running     (3 times a week).      All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able     to count the number of steps, determine a daily goal of steps, determine the covered distance     (in Km), determine daily caloric consumption, and determine the movements during sleep.   "
49497|NCT02637752|"     Background: Childhood obesity imposes a great burden on the healthcare system. Given the     increased frequency of dental compared to medical visits during childhood, dentists may be in     an ideal position to recognize patients at risk of developing obesity. This randomized     clinical trial explored the efficacy of a brief nutrition and physical activity counseling     for healthy weight 6 to11 year-old children in a university-based pediatric dental clinic.      Methods: 168 children, 6-11 year old, were allocated to test and control groups and their     Body Mass index (BMI) were recorded. Their parents/caregivers completed a questionnaire     regarding their child's nutrition, physical activity and screen time. The parents/caregivers     of the test group then received a brief counseling session that encouraged an increase in     children's physical activity, and a decrease in sugar-sweetened beverages and screen time.     Data, collected at baseline and follow-up session (within 6-12 months) were analyzed using     general linear regression, adjusting for age, gender, socio-demographic characteristics,     education, labour force, income and awareness of school nutrition policy (P≤ 0.05).   "
49498|NCT02637739|"     About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on     first visit and are classified as pregnancy of unknown location (PUL). The etiology includes     ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of     ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D&C,     and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to     evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.   "
49499|NCT02637726|"     In children, only a few studies have compared different modes of propofol infusion during a     total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is     to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values)     between four modes of propofol infusion: titration of the infusion rate on clinical signs     (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion     (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI     SBIS).      Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the     anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate     BIS values (45-55), the bias and imprecision will be calculated.   "
49500|NCT02637713|"     Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy.     Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is     an endoscopic FDA approved device that improves symptoms of GERD, there is minimal     information about its use on patients after sleeve. This registry will attempt to get     information regarding the treatment of reflux using Stretta after sleeve gastrectomy.   "
49501|NCT02637700|"     Small fiber neuropathy (SFN) is the most common cause of neuropathic pain in peripheral     neuropathies, with a prevalence of at least 53/100.000. Patients with SFN may have     excruciating pain and current anti-neuropathic and other pain drugs do not relief pain     substantially.      Several studies suggested an immunological basis in SFN and case studies have reported     efficacy of treatment with intravenous immunoglobulin (IVIg) in patients with SFN. It is     therefore conceivable that immunological mechanisms play a role in idiopathic SFN (I-SFN).     However, to date no randomized controlled study with IVIg in patients with SFN has been     performed. The aim of the current study is to investigate the efficacy and safety of IVIg in     patients with I-SFN in a randomized, double-blind, placebo-controlled study.      The objective of the study is to evaluate the efficacy of IVIg treatment (4 courses of     treatment, 3 weeks apart) compared to placebo on pain alleviation.   "
49506|NCT02637635|"     The purpose of this study is to determine if autologous fat transplantation as a     pre-treatment gives better results in breast reconstruction with implants after mastectomy     and radiotherapy. One group is randomized to conventional reconstruction with implant and one     to pre-treatment prior reconstruction with implant.      Our aims are:        1. To study whether lipofilling can decrease the number of reoperations and complications          such as postoperative infections or not.        2. Evaluate the aesthetic results and the patients' experiences. For both these aims the          hypothesis is that pre-treatment is in favour for the outcomes.   "
49507|NCT02637622|"     In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify     the principal benefit-risk factors FDA considers during the reviews for premarket approval     applications and de novo classification requests. In addition to a detailed description of     benefits and risks, CDRH listed patient tolerance for risk and perspective on benefit as a     factor that CDRH may consider in regulatory reviews. It underlined the need for developing     methods to measure patient preference and incorporate it into regulatory decision-making. The     purpose of this study is to advance methods for patient and community engagement in     patient-centered outcome research (PCOR) and has three objectives.      First, demonstrate good practices for patient and community involvement in PCOR projects by     applying principles of community-based participatory research (CBPR).      Second, address methodological gaps pertaining to the use of stated-preference methods in     studying preferences in PCOR. These include identifying the best methods for designing a     preference study and strategies for analyzing variation in preferences. The investigators     also seek to assess the relevance of stated-preference methods to patients and stakeholders     using both qualitative and quantitative methods.      Third, demonstrate good practices for applying stated-preference methods by studying the     preferences of patients with type II diabetes. While type II diabetes provides an important     case study, this research will advance approaches and methods that will be broadly     generalizable to other diseases, and to diverse patient and stakeholder groups.      Clinical Significance:      This project will illustrate and advance methods for assessing the values of patients and     stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of     stated-preference methods in measuring the preferences of patients and stakeholders and     directing health care.   "
49508|NCT02637609|"     In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify     the principal benefit-risk factors FDA considers during the reviews for premarket approval     applications and de novo classification requests. In addition to a detailed description of     benefits and risks, CDRH listed patient tolerance for risk and perspective on benefit as a     factor that CDRH may consider in regulatory reviews. It underlined the need for developing     methods to measure patient preference and incorporate it into regulatory decision-making. The     purpose of this study is to advance methods for patient and community engagement in     patient-centered outcome research (PCOR) and has three objectives.      First, demonstrate good practices for patient and community involvement in PCOR projects by     applying principles of community-based participatory research (CBPR).      Second, address methodological gaps pertaining to the use of stated-preference methods in     studying priorities in PCOR. These include identifying the best methods for identifying     patient priorities and strategies for analyzing variation in priorities. The investigators     also seek to assess the relevance of stated-preference methods to patients and stakeholders     using both qualitative and quantitative methods.      Third, demonstrate good practices for applying stated-preference methods by studying the     priorities of patients with type II diabetes. While type II diabetes provides an important     case study, this research will advance approaches and methods that will be broadly     generalizable to other diseases, and to diverse patient and stakeholder groups.      Clinical Significance:      This project will illustrate and advance methods for assessing the values of patients and     stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of     stated-preference methods in measuring the priorities of patients and stakeholders and     directing health care.   "
49509|NCT02637596|"     A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients     treated with intraoperative radiofrequency ablation (RFA).   "
49510|NCT02637583|"     The purpose of the present study is to compare the immunological response of pneumococcal     serotype specific B-cells, the humoral immune response and safety after sequential     vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine     (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in     a prospective, randomized controlled monocentric head-to head clinical study in elderly. The     hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve     an improved immune-response compared to sequential vaccination or single vaccination.      Adults >=60 years without previous pneumococcal vaccination will be randomized in three     groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination)     or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they     receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal     serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and     PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A) and     vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against the 12     vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all three     groups. Adverse events will be recorded for 28 days after each vaccination.   "
49511|NCT02637570|"     This study evaluated effect of Hibiscus tea and green tea supplements on athletic     performance, blood pressure, muscle damage indices and oxidative stress in male athletes     18-35 years old and cardiovascular disease prevention approach.   "
49512|NCT02637557|"     The objectives of this study are to evaluate the safety, efficacy, and dose-response     relationship of IW-3718 administered orally to patients who have GERD and continue to     experience GERD symptoms while receiving once-daily (QD), standard-dose PPIs   "
49513|NCT02637544|"     Aim of this randomized clinical trial is to examine the treatment effectiveness of an     acupuncture protocol in adult patients with non chronified TMDs.   "
49514|NCT02637531|"     This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects     with advanced solid tumors.   "
49579|NCT02636686|"     This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who     previously have been treated with drisapersen, aiming at assessing the safety and efficacy of     drisapersen.   "
49580|NCT02636673|"     Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic     sigmoid resection for both benign and malignant disease   "
49523|NCT02637414|"     This protocol proposes a well-being program, delivered through an application for mobile     devices, based on meditation and positive psychology principles such as human development,     the improvement of virtues, quality of life and well-being. The investigators hypothesize     that this program offered in mobile application may promote well-being and reduce stress     related problems in the participants.      Objectives: To evaluate the effectiveness of a well-being program delivered through an     application for mobile devices in a sample of employees who work in a company (Natura     Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).      Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees     from Hospital Israelita Albert Einstein will be recruited. The participants will be     randomized in two groups of 125 participants each one, half of them in the control group (GC)     and the other half to the intervention group (GI), by institution.   "
49515|NCT02637518|"     There is a proved strong evidence of the usefulness of frailty as a predictive factor of     relevant and desired outcomes in populations of older adults. Several studies have been     published showing the utility of the concept in improving the prognosis accuracy and the     prediction of different risks (hospitalisations, surgical and non surgical complications,     length of stay, death, incident disability, etc.) in emergency departments, surgical     patients, and inpatients with cardiovascular disease. The studies have placed the focus in     assessing population risk, while the validation process for these instruments as diagnosis or     screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as     screening and diagnosis tools of some selected instruments to detect frailty in both clinical     (Hospital and Primary Care) and social (Nursing Homes) settings, providing diagnostic     algorithms clinically sound. Target groups are all of those older adults at risk of frailty     (pre-frail) plus those that are frail and are at risk for developing disability. According to     the published prevalence of these two conditions, the target population concerned by this     project represents around 40-50% of people older than 65, and 60-70% of people older than 75.     Once determining the best tools of screening and diagnosis in different settings of care,     investigators will research conclusions of these people wherever the level of care they need     and currently use. The benefit will spend to the Health System and Social Care as it will     provide validated instruments that are necessary to provide an appropriate care for older     adults by means of a comprehensive, continued, coordinated and integrated care.   "
49516|NCT02637505|"     114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will     be randomized to either receive arthroscopic microfracture or arthroscopic debridement. Both     groups will then undergo a systematic physiotherapy training regime for 6-9 months. The     groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated     patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D as well as clinical     examination and radiological findings at 2 years (MRI).   "
49517|NCT02637492|"     Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial     disease (POAD). Despite progress in the revascularization procedures, half these patients     experience amputation or death after one year. One issue is to identify these subjects     because aggressive treatment is necessary in those cases, while in others (ie leg ulcer in a     patient with POAD but no rest lower limb ischaemia), revascularization will not be necessary.     Then it would be useful to develop a simple score to help the physician to improve diagnosis     of CLI.   "
49518|NCT02637479|"     80% of palliative care cancer patients suffer from severe pain. The management of these pain     improves the quality of life of these patients. The management of opioid pain refractory to     date remains a difficulty for caregivers. Hypophysectomy performed to try to control     hormone-dependent neoplasia also help relieve pain associated with lesions secondary cancer.     The surgical hypophysialis radio Gamma Knife ® was recently performed on a small number of     patients. She would have the advantage of reducing the risk of complications compared to     other techniques and achieve similar analgesic effect on diffuse, or mixed nociceptive pain     associated with metastases on average in 2 days and would reduce or stop opiates most often     responsible for side effects impairing the quality of life. The objective of this clinical     trial, multicenter, prospective, randomized controlled is to evaluate the effectiveness of     surgical hypophysialis radio for patients in palliative situations with refractory cancer     pain in opioid level III. The type of pain cancer pain was done in order to optimize the     recruitment and homogenization of the study population: patients cared for in palliative care     units are mostly patients cancer (70-80%). This study is therefore part of a palliative     setting and the results of this test can be extrapolated to other populations of palliative     patients with refractory pain.   "
49519|NCT02637466|"     The purpose of this antidepressant study is to determine the efficacy of vortioxetine on     depression and cognition in 80 women with breast cancer, and to elucidate     inflammatory-mediated mechanisms by which depression and its treatment influence cancer     outcome. Our hypothesis is that effective vortioxetine antidepressant therapy in depressed     women with breast cancer will attenuate increased intermediate endpoints of inflammation that     contribute to the pathogenesis of depression, cognitive impairment, and cancer progression   "
49520|NCT02637453|"     Pulmonary vein(PV) isolation has become the cornerstone of radiofrequency ablation for AF.     However, recent reports have clearly shown that the longer the follow-up period, the lower     the success rate with a single ablation procedure. In 5-year follow-up, the mean success rate     was only about 45%. The purpose of the study to investigate whether the linear ablation     perpendicular to the PV ostium on the basis of circumferential pulmonary vein isolation, can     reduce recurrence rate of AF. All patients will be followed up for 12 months. And fourteen     days Holter will be performed at the end of follow-up.   "
49521|NCT02637440|"     In patients with ST elevation myocardial infarction (STEMI) the treatment goal is     revascularization of the occluded artery with the use of primary percutaneous coronary     intervention (PCI). There is a large subset of patients with STEMI who also have significant     disease in arteries other than the site of occlusion, and away from the culprit artery. It is     estimated that up to 50% have disease of more than 50% in the non-culprit arteries.      The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier     large-scale studies and registries have suggested early and complete revascularization is of     no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT     study showed that early complete revascularization or preventive PCI reduced primary endpoint     of a composite of all cause mortality, myocardial infarction and need for repeat     revascularization. The benefit was mainly due to reduced repeat revascularization in the more     intensive intervention group. The PRAMI study showed very similar results as well.      The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also     showed conflicting results so far. A previous trial showed that FFR guided intervention post     STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided     complete revascularization improved outcome when compared with more conservative treatment of     ischaemia driven intervention.      In this study, the investigators are going to assess the issue of staged revascularization     guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven     revascularization   "
49522|NCT02637427|"     The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in     patients with moderately elevated international normalized ratios (INR) prior to undergoing     an invasive procedure.   "
49524|NCT02637401|"     Bipolar Disorders (BD) typically involve repeated episodes of both depression and excessively     high mood or irritability (hypomania or mania). BD presents considerable challenges for the     individual, his or her supporters, and society more generally. Medication is generally     considered to be the mainstay treatment, however a substantial number of individuals with BD     continue to experience episodes despite use of medication. Furthermore, ongoing mood     instability either outside of episodes, or as the main feature of their BD, is a significant     difficulty experienced by many. Whilst studies suggest that certain psychological therapies     can be helpful for people experiencing full bipolar episodes, or to reduce risk of future     episodes, there are no evidencebased psychological therapies available for individuals     experiencing ongoing mood instability. Dialectical Behaviour Therapy (DBT) was developed     several decades ago as an approach for people with Borderline Personality Disorder. DBT aims     to give individuals who experience rapid and intense shifts in affect skills for managing     this. Despite the many similarities in the symptoms experienced by individuals with     Borderline Personality Disorder and those with Bipolar Disorder only a small number of     studies have tested DBT for BD, and no studies to date have specifically investigated DBT as     a means to help individuals with ongoing mood instability. We have developed a version of     groupbased DBT that draws upon our own research to adapt standard DBT for this client group     (DBTBD).      The group is designed to be delivered efficiently within the U.K. healthcare system whilst     meeting the needs of individual participants through use of additional individual sessions     and a mobile phone application. The current study investigates how acceptable DBTBD is to     clinicians and patients, and whether - for the small number of individuals in the study     -changes in symptoms and key ways of thinking and behaving appear to take place across the     period of treatment.   "
49525|NCT02637388|"     The purpose of this study is to address the effect of consuming 4g of soluble fibre     beta-glucan at breakfast on satiety and food intake.   "
49526|NCT02637375|"     Based on preclinical data implicating GR, AR, and JAK/STAT activation as potent mechanisms of     breast cancer cell survival despite chemotherapy administration (i.e. chemotherapy     resistance), the study will test a novel approach for improving chemotherapy effectiveness by     adding Hsp90 inhibition to antagonize the anti-apoptotic signaling pathways that are     initiated via GR, AR, and JAK/STAT activation.   "
49527|NCT02637362|"     A randomised trial comparing three analgesic strategies for patients undergoing forefoot     surgery in a day-surgery setting.   "
49528|NCT02637349|"     The POST's public health impact is likely to be substantial because it will improve cancer     survivorship planning, which is currently an important deficiency in cancer care recognized     by the Institute of Medicine and the American College of Surgeons.      The POST may have many potential benefits for patients such as:        1. improved long-term health outcomes;        2. improved psychosocial outcomes and quality of life;        3. smoother transitions back into old and new life roles; and        4. improved continuity and coordination of care between providers.      Most importantly, the POST's influence may reach beyond the patients it directly serves as it     could help scientists and health care providers understand the potential benefits of cancer     survivorship planning and how to best design and implement survivorship planning when     patients are ending treatment for cancer.   "
49529|NCT02637336|"     The aim of this study was to evaluate the acute cardiovascular responses in hypertensive     individuals, in waking and sleeping periods after application of different     non-pharmacological therapies for the control of blood pressure (BP). Randomly and random     volunteers held a session of each therapy: Acupuncture, aerobic exercise, essential oil     inhalation, and session control with a minimum interval of 72 hours between them. On the day     of sessions the volunteers did not use antihypertensive medication. The variables measured in     the survey were the blood pressure and heart rate variability (HRV). Descriptive statistical     averaging procedures, standard deviation and standard error of mean were adopted. Two-way     ANOVA for repeated measures was performed post-hoc Tukey. The level of the study significance     was set at p <0.05.   "
49530|NCT02637323|"     This is an open-label, single administration study of 32 mg of FX006 and Triamcinolone     Acetonide Injectable Suspension, USP (referred to as TCA IR in the protocol) conducted in     male and female patients with Osteoarthritis (OA) of the knee.   "
49531|NCT02637310|"     A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical     trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis   "
49532|NCT02637297|"     This randomized pilot clinical trial studies hypnotherapy in treating chronic pain in cancer     survivors. Hypnotherapy is a state of concentration and focused attention which can provide     more control over the experience of acute and chronic pain and its impact and may provide     comfort, maximize function, and improve quality of life in cancer survivors.   "
49533|NCT02637284|"     Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157,     a pentadecapeptide from gastric source.   "
49534|NCT02637271|"     In order to better understand how commonly used dietary interventions for obesity influence     brain activity and in turn people's ability to adhere to their healthy nutrition plan, the     investigators need to study how people's brains react to food cues while undergoing such     interventions. Our study will add to our understanding of neural (brain) regulation of     hedonic and homeostatic mechanisms (i.e. pleasure and hunger) in influencing adherence to     calorie-reduced eating plans.   "
49581|NCT02636660|"     This study will allow us to determine the perceived Health-Related Quality of Life (HRQL) a     year after ICU discharge, and compare it with HRQL measured earlier on in the process, as     well as analyse the negative experiences they had while in the ICU and as a result of MV and     their impact over time. It will also allow us to assess the effect of Nursing Sensitive     Outcomes and ICU stressors on health-related outcomes and how they affect HRQL.   "
49582|NCT02636647|"     Randomized, open-label safety, tolerability study with exploratory endpoints and     pathophysiological evaluation of the FMT      Two groups of outpatients with cirrhosis will be randomized using random sequence generator     into no-treatment and FMT groups.   "
49638|NCT02635919|"     The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and     preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for     Medication Adherence of Rx Pill), a smartphone application (app) for improving medication     adherence among substance users. The investigators will compare 2 groups of cigarette smokers     undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the     mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart     pillbox that will a record a date and time-stamped medication event whenever pill box is     opened and closed, and thus allow for primary measurement of medication adherence) and b) a     control group using the MEMS Cap and mobile web-based surveys on their smartphone.   "
49535|NCT02637258|"     This study is designed as a multicenter, prospective, cohort clinical study. The out of     hospital cardiac arrest (OHCA) patients presenting to the adult emergency departments of the     participating hospitals will render the study population. The non-traumatic, non-intracranial     event related OHCA patients in whom the return of spontaneous circulation (ROSC) is achieved     will render the sampling group.      The primary aim of this study is to evaluate the relationship of bedside ultrasound (USG)     measurements of Optic Nerve Sheath Diameter (ONSD) following the ROSC after Cardiopulmonary     resuscitation (CPR) for OHCA patients, with early (3rd day) neurological evaluation and 30     days survival rate, proposing that increased ONSD may be related to negative neurological     outcomes. Considering a relationship is found, the secondary goals of the study are     established as, identifying a cut-off value for ONSD related to negative neurological outcome     and the optimal time to measure ONSD.      The sampling size with a power of 95% is calculated to be 203 patients. The patients whose     available next of kin has given consent will be admitted to the study.   "
49536|NCT02637245|"     Diabetic macular edema (DME) is the most common cause of vision loss in diabetic patients.     While anti-VEGF treatments and to a lesser extent corticosteroid and macular photocoagulation     have improved outcomes in patients with DME, no single therapy is universally effective and     currently there is no a priori means of determine which patients will respond best to any     given therapy. The purpose of this study is to determine whether specific parameters of     ocular imaging studies including optical coherence tomography and fluorescein angiography can     predict response to treatment in patients with DME. This is a prospective observational     cohort study that will collect clinical data and imaging studies obtained as standard of     care. Up to 150 subjects with clinically significant DME will be enrolled at Duke Eye Center     or its satellite offices. These imaging studies will be analyzed to determine whether     specific parameters are associated with poor or favorable response to specific treatments.     There will be no intervention as part of this observational trial, thus the primary risk to     subjects is loss of confidentiality, which will be minimized by the study team.   "
49537|NCT02637232|"     The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso®     / Onreltea TM (trade mark) is prescribed.   "
49538|NCT02637219|"     The purpose of this study is to determine whether the response of the immune system to     bacterial components differs between patients with severe COPD compared to those with less     severe COPD.   "
49539|NCT02637206|"     GSK2894512 is a novel anti-inflammatory agent that is currently under development for the     topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a     Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists     of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a     single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by     simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy Japanese     volunteers. Part 2 of this study will assess skin irritation following repeat application at     0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive condition in 6     healthy Japanese volunteers. The study will have Screening visit which will occur within 30     days from the Day 1 visit of each part. Eligible subjects will be able to participate either     of Part 1 or Part 2. Subjects will visit the site on Day -1, and hospitalized until the end     of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects will re-visit the site on     Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This study will be the first to     evaluate the safety, tolerability and pharmacokinetics of GSK2894512 cream after single and     repeat application in Japanese subjects. Results from this study will enable further clinical     investigation in the Japanese population.   "
49540|NCT02637193|"     The purpose of this study is to demonstrate a lack of effect of venlafaxine (Effexor XR) on     QTc intervals relative to time matched placebo in healthy volunteers   "
49541|NCT02637180|"     This is multiple center, prospective study aiming to investigate the tracking and outcome of     patients attending Greek General hospitals with low-trauma fractures. Secondary end-points     were to facilitate the implementation of coordinated, multi-disciplinary models of care for     secondary fracture prevention, and to monitor osteoporosis treatment initiation, osteoporosis     treatment persistence at 12 months, compliance, and subsequent fractures.   "
49542|NCT02637167|"     The objective of this trial is to study the effect of targeting the gut microbiota in     patients with heart failure (HF). First, the investigators will characterize gut microbiota     composition in patients with various degree of systolic HF as compared with healthy controls.     Second, the potential impact of targeting gut microbiota to improve HF will be investigated     through an open label randomized controlled trial (RCT) of probiotics, antibiotics and     controls. The hypothesis being tested is that the gut microbiota is altered in HF; that gut     microbiota of HF patients, through interaction with the intestinal and systemic innate immune     system, contribute to a low-grade systemic inflammation as well as metabolic disturbances in     these patients; and that an intervention with probiotics and the non-absorbable antibiotic     Rifaximin attenuates these inflammatory and metabolic disturbances and improves heart     function through modulation of the gut microbiota.   "
49543|NCT02637154|"     This study investigates the effect of motivational interviewing and intensive education on     HbA1c values and glucose variability in poorly controlled adolescent T1D patients.      In the present study motivational interviewing (MI) will be integrated to clinicians' daily     practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis     is, that applying motivational interviewing during regular clinical visits results in better     acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled     type 1 diabetes.   "
49544|NCT02637141|"     Protocol CELIM-NRCD-001 is designed to be a Phase 2a, randomized, double-blind,     placebo-controlled, parallel-group study to evaluate the efficacy and safety of AMG 714 for     the attenuation of the effects of gluten exposure in adult patients with celiac disease     during a gluten challenge.   "
49545|NCT02637128|"     This study was designed to determine the efficacy of both artemether-lumefantrine and     artesunate-amodiaquine (but not to compare the efficacies of the two drugs) for the treatment     of uncomplicated Plasmodium falciparum malaria at Machinga, Nkhotakota, and Karonga District     Hospitals- Malawi.   "
49546|NCT02637115|"     Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity are     characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin     resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation) representing     a major public health problem. Therefore, it is urgent to find a therapeutic solution to     target all these metabolic disorders. Among the environmental factors able to influence the     individual susceptibility to gain weight and to develop metabolic disorders associated with     obesity, more and more evidence show that the trillions of bacteria housed in our     gastro-intestinal tract (i.e, gut microbiota) influence host metabolism. The investigators     recently discovered a putative interesting microbial candidate, namely Akkermansia     muciniphila (Akk). More exactly, we found that the administration of Akkermansia muciniphila     reduced body weight gain, fat mass gain, glycemia and inflammatory markers in diet-induced     obese mice. Moreover, in overweight/obese patients with cardiovascular risk factors subjected     to a calorie restriction diet (calorie restriction diet for 6 weeks and an additional 6 weeks     of weight maintenance), a higher abundance of Akkermansia muciniphila was associated with a     better cardio-metabolic status in these patients. The investigators also discovered that     patients having more Akkermansia muciniphila in their gut before the calorie restriction     exhibited a greater improvement in glucose homoeostasis, blood lipids and body composition     after calorie restriction. These observations suggested that the administration of     Akkermansia muciniphila in overweight or obese people could be a very interesting therapeutic     solution. Currently, no human study has investigated the beneficial effects of Akkermansia     muciniphila administration on obesity and metabolic disorders. The overall objective of this     study is to evaluate the effects associated with the administration of live or heat-killed     Akkermansia muciniphila on the metabolic disorders (insulin-resistance, type-2 diabetes,     dyslipidemia, inflammation) related to overweight and obesity in humans.   "
49547|NCT02637102|"     CAVIAR is a multicentre prospective observational study. Centres for cardiac and vascular     surgery assess and manage patients in different ways before surgery. Some centres have     introduced the use of intravenous iron therapy for patients with anaemia in the preoperative     setting. Consequently regional variation exists in the assessment and management of patients     before cardiac and vascular surgery. We aim to observe and measure these differing pathways     and observe if there is variation in iron deficiency and anaemia and the impact of these     variables on patient cardiorespiratory function as well as post-operative outcomes.      [Sub-Study] For patients who are receiving intravenous iron therapy as part of their routine     clinical care, we wish to observe this effect in more detail. We will assess the impact of     the treatment on well-being, blood count and fitness. Information will be collected through     Quality of Life questionnaires, total haemoglobin mass test (via blood collection) and     fitness testing.   "
49548|NCT02637089|"     Parkinson's disease (PD) is known for its motor symptoms and affects more than 100,000     Canadians. However, PD patients also show cognitive deficits and neuropsychiatric problems     that significantly impair their quality of life. The occurrence of dementia in PD is much     higher than in the general population. The proposed study will allow the principal     investigator, his team and his collaborators to investigate the origins and evolution of the     cognitive and neuropsychiatric symptoms. Participants with PD with and without mild cognitive     impairment (MCI) and participants with and without MCI over the age of 60 years will be     assessed during eight study visits over three years. Through brain imaging, clinical testing,     as well as genotyping the cognitive patterns in the four different groups will be observed     and compared. The results will be used to identify biomarkers that can predict the occurrence     of dementia early in the disease. Ultimately, the results of the proposed research will     contribute to interventions and treatment strategies tailored to different cognitive profiles     in PD before the occurrence of dementia.   "
49549|NCT02637076|"     The overall aim is to establish whether the drug Xyrem® has an action on the brain dopamine     system in patients with narcolepsy.      Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve     narcolepsy with cataplexy patients, whether a single dose of Xyrem® causes changes in     striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered activity of brain     dopamine neurones.   "
49550|NCT02637063|"     This project will develop and evaluate an interactive blood pressure self-management program     for adults with prehypertension. The program will target blood pressure self-monitoring and     the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary     Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and alcohol     consumption.      The multi-modal program uses a combination of brief motivational health coaching, periodic     engagement emails, and a robust interactive website to motivate people to take charge of     their blood pressure management before they require medication. All program components were     designed to conform to the underlying principles of motivational interviewing. Key program     components include the use of email and Web-based social networking, personal stories, and a     brief motivational coaching session to engage participants and encourage intrinsically     motivated behavior changes. Self-assessment and tracking tools are combined with educational     content to help participants align their daily lifestyle choices with their personal goals.      The Phase I prototype program promoted moderate physical activity and eating fruits and     vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation showed     moderate-to-large effect sizes for pre-to-post change in motivation, preparation behavior,     self-efficacy, attitudes, and knowledge, and a small significant increase in physical     activity. Participants gave the online program high ratings on satisfaction and usability,     and reported improvements in confidence, readiness, clarity, change strategies, and interest     in visiting the Website as a result of the coaching session.      The fully developed Phase II product will be evaluated in a large randomized trial (N = 450)     with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month     follow-up period. The Phase II trial is expected to show reductions in blood pressure and     improvements in JNC-recommended health behaviors. These changes in the outcome measures are     expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral     intention, motivation, and patient activation.   "
49551|NCT02637050|"     The aim of the registry is the assessment of the diagnosis and treatment of CTEPH (Chronic     Thromboembolic Pulmonary Hypertension) in EMEA (Europe/Middle East/Africa) countries.   "
49552|NCT02637037|"     This is a bioequivalence study to compare 2 fixed-dose combination tablets of     dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under     fasting and fed conditions   "
49553|NCT02637024|"     This is a multi-centre randomized phase II trial in women with invasive carcinoma of the     breast with negative axillary nodes or Ductal Carcinoma In-situ (DCIS) treated by Breast     Conserving Surgery (BCS). Eligible, consenting patients will be randomly allocated to receive     radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast     Irradiation (APBI) 30 Gray (Gy) in 5 daily fractions of 6Gy or 27.5Gy in 5 daily fractions of     5.5Gy over one week. Patients will be followed at 12, 24, 36 and 60 months post     randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel     of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer     Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).   "
49583|NCT02636634|"     The purpose of this multicenter study is to assess a diagnostic strategy concerning     differential diagnosis between radiation necrosis and relapse in brain metastases treated     with radiosurgery. Two non-invasive tests - positron emission tomography (PET) with     1F-fluoro-ethyl-tyrosine (FET) and magnetic resonance spectroscopy (MRS) - will be compared     to histology in a cohort of patients presenting growing lesions 6 months after radiosurgical     treatment.      The results of this study should help to earlier diagnosis of recurrences after radiosurgery     and to perform an appropriate treatment for patients.   "
49554|NCT02637011|"     The purpose of the DACAPO study (Surviving ARDS: the influence of quality of care and     individual patient characteristics on quality of life) is to investigate the role of quality     of care and individual patient characteristics on quality of life and return to work in     survivors of ARDS (acute respiratory distress syndrome). It is hypothesized that higher     quality of care is associated with better health-related quality of life and a higher rate of     return to work among survivors.      A prospective, observational, multi-centre patient cohort study is performed in Germany,     using hospitals from the ARDS Network Germany as the main recruiting centres. It is     envisaged to recruit 2400 patients into the DACAPO study and to analyze a study population of     1500 survivors. They will be followed up until 12 months after discharge from hospital.     Quality of care will be assessed as process quality, structural quality and volume at the     institutional level. The main outcomes (health related quality of life and return to work)     will be gathered by self-report questionnaires. Further data assessment includes general     medical and ARDS-related characteristics of patients as well as sociodemographic and     psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the     effects of quality of care and individual patient characteristics on outcomes, taking the     cluster structure of the data into account.   "
49555|NCT02636998|"     This study is designed to evaluate cognitive function in preadolescents who have different     body mass indexes.   "
49556|NCT02636985|"     Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a     mainstream tool for ultrasound-based diagnosis. This compressibility property of materials,     mathematically expressed as the change in tissue displacement as a function of its distance     from the compressing device, is known as strain and is the parameter that is imaged in an     elastogram.      Elastography has currently shown promising result in differentiating viscoelastic nature of     various organs, which is a consequence of certain underlying diseases.      At present, there are limited literatures revealing the application and feasibility of     ultrasonic elastography in lung lesions. This is essentially important as it may serve as an     adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and     feasibility of ultrasonic elastography on lung lesions.   "
49557|NCT02636972|"     This is a cross-sectional observational study.      For participants resident in Adelaide, South Australia.      The study consists of 3 visits to the Pain and Anaesthesia Research Clinic (PARC), within the     Royal Adelaide Hospital (RAH).      A total of 56 participants will be recruited for this study.   "
49558|NCT02636959|"     Chronic sinusitis (CRS) is a common inflammatory sinus condition among Canadians. Saline     irrigation is an effective therapy used in the management of CRS and is a commonly prescribed     treatment in preoperative surgery for people with this condition. Recently, a study performed     by a Toronto group in Canada tried to show if there is any significant improvement between     using high versus low volume saline irrigation to treat CRS. Despite finding a trend, the     number of people with CRS used in this pilot study was not large enough to conclusively     declare any difference between the two treatment groups.      PURPOSE: The purpose of this study is to determine if there is a clinical benefit of high     volume saline nasal irrigation (HVSI) over low volume saline irrigation (LVSI) in the     postoperative period in patients with chronic Rhinosinusitis (CRS). This study is part of a     multicenter collaborative project initiated by Macdonald et al. (20). A sample size of 176     participants (88 in each condition) is required to achieve data significance. To achieve     this, our role is to collect data (plus those of four other Canadian rhinology research     centres) from 20 patients and add our findings to theirs to establish an acceptable and     significant result. This information would help otolaryngologists, family physicians, and     other health care professionals recommend the best post-operative SNI (saline nasal     irrigation) device for their patients with CRS.   "
49559|NCT02636946|"     This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost     SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or     ocular hypertension who are not adequately managed with topical IOP-lowering medication.   "
49560|NCT02636933|"     The PRE-AR project is a longitudinal observational study. The primary objective is the     assessment of lung function parameters in late preterm preschool children.   "
49561|NCT02636920|"     It is an interventional prospective study. The study will assess the intervention of the     Therapeutic Education to the Patient (TEP) on the quality of life in asthmatic children.      The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 in the     outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease     Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of     the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.   "
49562|NCT02636907|"     This is an open-label, phase II study of BI 695501 to assess handling experience of patients     with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients     with additional exposure to BI 695501 and to enhance the safety database for this compound.   "
49563|NCT02636894|"     Filler study for smile lines in cheek folds   "
49564|NCT02636881|"     82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be     randomized to either receive autologous cartilage implantation or arthroscopic debridement.     Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The     Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated     patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5     dimensions) as well as clinical examination and radiological findings at 2 years (MRI).   "
49565|NCT02636868|"     The primary objective of this study is to evaluate the safety and efficacy of lucinactant for     inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks     gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for     Resipiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.   "
49595|NCT02636478|"     One questionnaire has been configured to ask therapy naive and treated patients about their     travel activities. Travel activities include private and professional traveling. Another     questionnaire collects medical information.   "
49596|NCT02636465|"     The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2)     with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under     flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic     chamber test.   "
49566|NCT02636855|"     This screening study is intended for men and women at least 18 years of age who have advanced     solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen     (HLA) subtype and tumor antigen expression profile. Based on the results, it will be     determined if a subject is eligible to be considered for Adaptimmune sponsored clinical     trials testing the safety and efficacy of genetically changed T cells targeting specific     tumor antigens. No treatment intervention will occur as part of this screening study.      Upon enrollment, subjects will be required to provide a blood sample for HLA subtype     analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion     criteria and do not express the HLA subtypes that are exclusionary for the available     interventional clinical trial(s), then the subject will be required to provide either an     archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at     a central laboratory for the expression (protein or gene) of multiple antigens which may     include, but are not limited to NY-ESO-1 and/or LAGE-1a and MAGE A10. Based upon the results     of these diagnostic analyses, if eligible, subjects will be referred to an appropriate     available interventional clinical trial(s) at the discretion of the Investigator.      Following screening, tumor samples will be retained by Adaptimmune for the purpose of     developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling     which is required for regulatory approval of a new therapeutic product indication.   "
49567|NCT02636842|"     The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole     lauroxil in adults with schizophrenia or schizoaffective disorder.   "
49568|NCT02636829|"     The main objective of this study is to measure, in patients with MS or Chronic Inflammatory     Arthritis (CIA), the correlation between two calcium intake assessment methods: A self     assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a     reference (gold standard) and based on data from CIQUAL *.      * CIQUAL Data: Nutritional food composition table available on the website of the ANSES     (National Agency for Sanitary Security of Food, Environment and Labour), published by the     Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58     nutritional components. The data is integrated into the software (DATAMEAL) for calculating     the ingesta parameters at the Nîmes University Hospital.   "
49569|NCT02636816|"     The investigators are investigating whether slow administration of carbetocin is tolerated by     patients better than if it is administered quickly, with respect to side effects such as     headache, nausea, vomiting and facial flushing.   "
49570|NCT02636803|"     The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris     trichiura at different doses in comparison to the standard single 400 mg dose of albendazole.     In addition, the study will provide data on oxfendazole efficacy against other common     nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma     duodenalis, Necator americanus).   "
49571|NCT02636790|"     The sinus surgical wait list in British Columbia continues to grow. The current wait list is     beyond what is acceptable by the province's standard; however, this is not likely to improve     given the budget constraints of the health care system. The outcome of having patients to     wait longer than medically reasonable for surgery, not only affects the patients' quality of     life but presents financial difficulties, both directly to the patient, the healthcare system     and the economy as a whole. Therefore, the investigators need to determine which patients     need to be prioritized for surgery. The investigators will follow two groups of patients -     one group from Stanford University who get surgery always before 8 weeks and compare them to     patients on the VGH wait list which is often more than one year.   "
49572|NCT02636777|"     Supported self-management (SM) is one of the key recommendations in management of chronic low     back pain (CLBP). SM programmes for patients with CLBP have failed to show clinically     meaningful improvement in pain and disability markers, which potentially reflect the lack of     treatment matching of SM programmes. Patient selection for a SM programme for patients with     CLBP is particularly difficult due to lack of extensive research on what predicts SM and its     change. The overarching purpose of this study is to identify predictors of SM and its change     over time in patients with CLBP. This study is a prospective non-experimental longitudinal     study.   "
49573|NCT02636764|"     Osteoarthritis is a chronic, multifactorial characterization, which changes in bone     alignment, cartilage and structures that provide joint stability appear to be strongly     correlated with the origin of this disease.This project will aim to verify the effectiveness     of interferential current, short wave and low level laser therapy on an exercise program for     mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups:     exercise group, exercise group + Ultrasound therapy, exercise group + interferential current,     exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and     after the trial protocol by the following instruments: Western Ontario and McMaster     Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual     Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the     World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain     scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical     agents in an exercise program will provide an improvement in pain, mobility and knee function     in individuals diagnosed with knee osteoarthritis.   "
49574|NCT02636751|"     This pilot single blind randomized controlled trial aims therefore to evaluate the     feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation     program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person     prehabilitation or to usual care.   "
49575|NCT02636738|"     Prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days follow     up for evaluate the safety and utility of VelaTM XL thulium laser.   "
49576|NCT02636725|"     The investigators hypothesize that combination axitinib with pembrolizumab will improve     progression-free survival relative to historical controls.   "
49577|NCT02636712|"     To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese     subjects   "
49578|NCT02636699|"     The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein     to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age     after a 12-month treatment by epicutaneous immunotherapy (EPIT).   "
49584|NCT02636621|"     Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized     by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness.     There are few studies about UARS treatment and there is not any gold standard treatment for     it yet.      Objective: Primary: To evaluate the efficacy of oral appliance on improving fatigue in     patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in     patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic     nervous system.      Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and     Respiratory Disturbance Index - RDI - > 5 events per hour or more than 30% of total sleep     time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue)     of both genders, with body mass index (BMI) lower than 30Kg/m2 and between 25 to 50 years of     age will be included. Subjects will be randomly distributed in OA group and placebo (without     treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to     sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography,     Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing,     autonomic nervous system analysis (heart rate variability) and metabolic evaluation. Mean and     standard deviation will be used for descriptive statistical analysis if normal distribution,     and median and percentiles (25%, 75%) for variables not normally distributed. To compare     treatment groups T test (parametric) and Mann Whitney (non parametric) will be used. For     adjusted analysis, linear regression analysis will be used.   "
49585|NCT02636608|"     The study seeks to provide evidence of the effectiveness and obtain patient reported outcome     (PRO) and work productivity data of the interferon-free regimen of Paritaprevir     (PTV)/ritonavir (r) + Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C     virus infected participants.   "
49586|NCT02636595|"     The purpose of this study is to evaluate the effect of response to treatment by evaluating     the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12     weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in     participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.   "
49587|NCT02636582|"     This randomized phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or     sargramostim works in treating patients with breast cancer. Vaccines made from peptide or     antigen and/or a person's white blood cells mixed with tumor proteins may help the body build     an effective immune response to kill tumor cells that express breast cancer. It is not yet     known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating     patients with breast cancer.   "
49588|NCT02636569|"     This research study will test how well two topical medications work to prevent the     development of non-melanoma skin cancers by reversing certain biomarkers in the skin. This     study is also looking at the optimal dose of a medication in a small number of people.     Biomarkers are molecules that are found in the body and inside of cells. Some biomarkers are     associated with specific diseases such as skin cancer. In this study, two topical medications     will be evaluated; diclofenac and alpha-difluoromethylornithine (DFMO).      Diclofenac and DFMO are approved by the Food and Drug Administration (FDA) for other uses. 24     patients will be enrolled in this study by UAB.   "
49589|NCT02636556|"     This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy     for locally advanced thymoma or thymic carcinoma.   "
49590|NCT02636543|"     The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of     information to the relatives after genetic diagnosis of a serious condition. This decree     includes a specific model of letter that can be sent to relatives by genetic professionals.     We evaluated the understanding and feelings after the reading of the decree's letter (letter     A) on patients and the public. A focus group drafted a new version of the letter (letter B)     through these observations. The two letter models (A vs B) are compared in terms of impact     through precise items (understanding and feelings) on three populations: patients, public and     genetic professionals. Assumption is made that the letter B will be preferred to the letter     A. Overall, we aim at giving a letter formulation accommodating as many people as possible to     standardize practices.   "
49591|NCT02636530|"     Bone responds according to the load placed on it. In this study, investigators want to know     if exercise that loads the body in exercises, like walking or jogging (Ground Reaction     Forces: GRF), affects bone differently than exercises that load the joints, like weight     lifting (Joint Reaction Forces: JRF). Participants will exercise at least 3 times a week for     6 months. Measures of bone strength and mass, muscular strength, and aerobic fitness will be     taken at the beginning and the end of the 6 month program. Period blood samples will be taken     for future analysis of blood markers.   "
49592|NCT02636517|"     Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or     without Inflammatory Bowel Disease (IBD)      The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric     patients with recurrent or moderate to severe C. Difficile without (through an observational     study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the     effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after     transplantation in these patients.   "
49593|NCT02636504|"     The objectives of this study are to determine the sensitivity, specificity, positive     predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in     determining the vitality of teeth and comparing with those of electric pulp testing and cold     testing.   "
49594|NCT02636491|"     Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and     efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery     system compared to sensor augmented pump therapy at patients with type 1 diabetes at home     Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose     sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours     blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at     patient's home.      The duration of study participation for one subject is 28-56 days and the overall duration of     the study is 6 months The participants of the study are patients ≥ 10 years until 65 years     with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose sensors.      Sample Size n = 45   "
49599|NCT02636426|"     Sorafenib is an oral anticancer drug and inhibits multiple protein kinases important for     tumor growth and metastases, including VEGFR, PDGFR, and RAF kinases. In daily clinical     practice it is currently used at a dose of 400 mg twice daily in a continuous schedule. In     this phase I study patients will be treated with a new dosing schedule of sorafenib: i.e. a     high-dose, pulsatile schedule. The tolerability and safety of this new schedule is examined     in exposure escalation cohorts based on a target plasma AUC0-12h (area under the curve).     Exposure escalation cohorts are used instead of conventional dose escalation cohorts because     the effect of a drug is dependent of its AUC levels and large differences in plasma sorafenib     AUC0-12h have previously been shown between patients treated at the same dose level. Using     pharmacokinetic monitoring, the sorafenib dose will be adjusted to a target plasma AUC0-12h.     The escalation cohorts consist of 3-6 patients per exposure level starting with a target     plasma sorafenib AUC0-12h level of 25-50 mg/L/h. After the determination of the maximum     tolerated AUC0-12h, 10 additional patients will be entered into an expansion cohort. In the     expansion cohort the patients will be treated with a weekly pulse of sorafenib at the maximum     tolerated AUC0-12h for further assessment of safety and preliminary exploration of efficacy.   "
49600|NCT02636413|"     The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking     and on patient management, and its reproducibility (Test-Retest), for the diagnosis of     hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose     intolerance.   "
49601|NCT02636400|"     Is postoperative IUI better than expectant management in infertile endometriosis patients     with good prognosis based on their EFI score? (A single centre randomised controlled trial).   "
49602|NCT02636387|"     This study assesses if using the medication desmopressin will decrease nightime bedwetting in     children with sickle cell disease. Half of the children will receive placebo and half of the     children will receive desmopressin, with the option to prescribe desmopressin as soon as the     study is completed.   "
49603|NCT02636374|"     The purpose of this study is to examine the effects of a guided imagery intervention on     perceived stress in pregnant adolescents.   "
49604|NCT02636361|"     This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the     different formulations of LY900014. This study will determine how the different formulations,     when injected under the skin, will affect the blood sugar levels in the body, and how safe it     is.   "
49605|NCT02636348|"     The primary objective of this randomized, double-blind, placebo-controlled trial is to     determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily     throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength     in Marine Corps recruits. The investigators hypothesize that Ca+D will prevent elevations in     PTH and result in greater increases in indices of bone strength compared to placebo.   "
49606|NCT02636335|"     The purpose of this study is to determine if an exposure to light in the morning has a     positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and     obese patients.   "
49607|NCT02636322|"     The goal of this clinical research study is to learn if the combination of rituximab,     lenalidomide, and ibrutinib, when given alone and with standard chemotherapy (called either     EPOCH - Etoposide, Prednisone, Oncovin [vincristine], Cyclophosphamide, and     Hydroxydaunorubicin [doxorubicin]; or R-CHOP - Rituximab, Cyclophosphamide,     Hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], and Prednisone), can help to     control diffuse large B cell lymphoma. The safety of this drug combination will also be     studied.   "
49608|NCT02636309|"     BACKGROUND: Individual approaches at the workplace might not be sufficient to control Work     Related Musculoskeletal Diseases (WMSDs) since they are multifactorial and refractory cases     might need an additional rehabilitation program.      OBJECTIVE: To evaluate multifaceted intervention efficacy to manage the WMSDs.      METHODS: A Nordic musculoskeletal questionnaire was applied pre and post intervention to     determine the efficacy of a multifaceted program, including ergonomics, exercise program and     acupuncture/physical therapy exercises orientation at the workplace in 126 workers of a     hearing-aid industry. Additionally, a self-perception survey (Likert scale) concerning     absenteeism, quality of life and work ability helped to evaluate the program that lasts one     year and ten months.   "
49609|NCT02636296|"     The purpose of the present study was to investigate the effects of 12-week Pilates-inspired     exercise on functional performance in community-dwelling older women.   "
49610|NCT02636283|"     This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain     free walking duration on patients with peripheral arterial disease, a condition caused by     decreased blood flow to the muscles in the legs.   "
49611|NCT02636270|"     With this study we want to investigate the pharmacokinetic (PK) effect of a single injection     of rhIGF-1 in patients with PAPP-A2 mutations compared to heterozygous carriers and healthy     controls. This will be followed by treatment of PAPP-A2 deficient patients with IGF-1 for a     period of one year to assess growth velocity. Additionally we want to further describe the     phenotypic characteristics of patients with PAPP-A2 deficiency.   "
49612|NCT02636257|"     To compare the clinical effects between the silicone nasolacrimal intubation under     nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.   "
49613|NCT02636244|"     The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied     topically to adult patients with alopecia areata of the scalp.   "
49614|NCT02636231|"     The purpose of this study is to determine whether endostar and IMRT is effective in the     treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.   "
49637|NCT02635932|"     The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects     the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to     difficulty in manual function and decrease the patient's quality of life. Immobilization of     TMC thumb joint by bracing has been effective in reducing pain and improving function.     Objective: To compare the effectiveness between day and night functional splint for patients     with trapeziometacarpal osteoarthritis in improving pain and function   "
49640|NCT02635893|"     This is a randomized, experimental study that examines the physiology of central nervous     system pathways contributing to the control of bilateral movements in individuals with spinal     cord injuries and promotes the recovery of lower-limb motor function through the use of     stimulation and locomotor training.   "
49615|NCT02636218|"     Subarachnoid hemorrhage (SAH) or bleeding in the brain as a result of ruptured aneurysm is a     devastating type of stroke. Many patients who undergo emergent neurosurgery to repair the     aneurysm and remove the bleeding suffer from complications in their subsequent hospital stay,     the most frequent and morbid of which is delayed cerebral ischemia (DCI) or small strokes     resulting from impaired blood flow to certain vital brain centers. This occurs because of     changes to the brain's blood vessels that occur after the bleed. The arteries can become     narrow (spasm) or small clots can form within the vasculature that disrupts normal blood     flow. Patients are left with profound neurologic deficits from these secondary complications.      Anesthesiologists, neurosurgeons, and intensivists are in need of a way to protect the brain     during this vulnerable period following aneurysm repair. One drug that may provide such     protection is ketamine, a compound frequently used in operating rooms and intensive care     units to provide anesthesia and analgesia. Ketamine works by blocking glutamate receptor ion     channels that play a pivotal role in promoting brain cell death during strokes by flooding     the brain with too much calcium and dangerous chemicals. This project is designed to test the     efficacy of ketamine in protecting the brain following aneurysm repair by using a controlled     infusion of the drug in the intensive care unit (ICU) when patients return from their     operation.   "
49616|NCT02636205|"     The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy for     children with hand and arm weakness. The Armeo®Spring Pediatric is a device that supports the     weight of the child's arm and uses joystick that helps to play computer games. The child will     be assessed before and after this therapy. Participating children with upper extremity     impairments will receive therapy 3x/week for 6 weeks during 30-45 minutes sessions at     progressively increasing degrees of difficulty. Each child's performance will be tracked with     regard to time necessary to complete a predetermined number of trials of the activity. The     standardized assessment tools that will be used are the Assisting Hand Assessment (AHA), Box     & Blocks test, Jebsen Taylor hand function test, and the Pediatric Evaluation of Disability     Inventory-Computer Adaptive Test (PEDI-CAT). Data will be analyzed to determine the efficacy     of this training method.   "
49617|NCT02636192|"     The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among     participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure     propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i)     versus new use of various other antihyperglycemic agents (AHAs), combined as one group.   "
49618|NCT02636179|"     Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of     fertility decline likely caused by changes in both environment and social behaviour.     Considering this large usage, it is important to evaluate the potential risk on the health of     children conceived using ART.      According to the literature, children born after ART are more likely to be at higher risk of     health problems than spontaneously conceived ones. Interestingly, recent studies suggested an     increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).      The purpose of this study is to evaluate the prevalence of asthma in school adolescents from     a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to     a control group composed of the same age range spontaneously conceived individuals.      The expected outcome of this study will provide new information regarding these children to     ART professionals of and to their own families, by focusing on an age range (between 11 and     15 years) for which very little information is available to date.   "
49619|NCT02636166|"     Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre     and provide a sample of urine from the same void for further testing.      Volunteers will then complete a product usage questionnaire and leaflet comprehension     questionnaire at site.      Follow-up information will be required from all volunteers as both additional urine sample(s)     and pregnancy information to establish true pregnancy status at the study visit.   "
49620|NCT02636153|"     The purpose of this study is to investigate the effects of normal diet and low-phosphate diet     on the level and the circadian pattern of serum phosphate concentration in normal subjects     and to explore the underlying mechanisms.   "
49621|NCT02636140|"     This study will examine the effects of different colors of light on pupil function and     alertness.   "
49622|NCT02636127|"     Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage,     cutaneous and visceral fibrosis and a dysimmune condition.      Therapies in this disease remain insufficient and the complications resulting from organs     involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a     strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved     in the vascular damage of the SSc. However mechanisms at the onset of this endothelial     cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue     remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound     adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune     populations. The purpose of the project is to define the role displayed by cytotoxic,     circulating immune populations of SSc patients in endothelial cytotoxicity as well as the     role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune     cytotoxic cells and the endothelium.   "
49636|NCT02635945|"     This study is the second Phase-II trial analyzing efficacy outcomes of PBF-680 in asthmatic     subjects, following the supportive data from the proof-of-concept trial on the effect of     PBF-680 on airway hyperresponsiveness to adenosine monophasphate (AMP). The purpose of the     present study is to provide an assessment on the efficacy of a 5-day treatment course of once     daily, orally administered, 10-mg PBF-680 doses, to attenuate Late Asthmatic Responses     (LAR) as a primary efficacy outcome. The study also aims at analyzing the effect of the     PBF-680 treatment course on airway inflammation-related outcomes including airway     hyperresponsiveness to AMP at 24 h after allergen bronchoprovocation, plus nitric oxide     fraction in exhaled air (FeNO) and airway inflammatory cells counts in induced sputum under     the effect of an additional 10-mg PBF-680 dose on the 6th treatment period day. Overall, the     study aims at providing evidence on the efficacy of PBF-680 on outcomes, particularly the     LAR, that are well established to screen valid drugs for asthma maintenance therapy.   "
49651|NCT02635750|"     Part I:      To investigate whether and to what extent donepezil affects single dose pharmacokinetics of     BI 409306      Part II:      To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics     of donepezil   "
49623|NCT02636114|"     ABSTRACT:-      Introduction:      Chronic periodontitis (CP), the commonest type of periodontal disease, it is an infectious     disease resulting in inflammation within of the tissues supporting the teeth, progressive     loss of attachment and bone loss. It is closely related to several systemic diseases, such as     diabetes and cardiovascular disease. The link between periodontal disease and chronic kidney     disease (CKD) may be due to infection and inflammation. The periodontal inflammatory state     may increases the chronic inflammation present in CKD, thus decreasing renal function.     Periodontal therapy may reduce inflammation and improves endothelial function.      Aim:- To investigate the effect of mechanical non-surgical periodontal therapy on serum renal     function markers in systematically healthy CP subjects.      Objectives:- To evaluate the effect of scaling and root planing (SRP) on serum renal function     markers such as urea, creatinine, bilurubin in systematically healthy CP patient and to     compare the clinical parameters such as Gingival index (GI), Plaque index (PI), Probing depth     (PD), Bleeding on probing (BOP), Clinical attachment level (CAL) between test group (TG) &     control group (CG).      Materials and Methods: - 51 CP patients; age ranging between 35-60 years was selected.     Categorized equally into group I and groups II. Group I was test group (TG) included 25     patients and group II was control group (CG) included 26 patients. The serum levels of renal     function markers included Urea, Creatinine, Bilurubin were measured. SRP was done in test     group only. All the parameters were checked at baseline and one month after SRP. Comparisons     of baseline and value after 1 month among each criterion among each group unpaired-t test and     comparisons of two groups for each criterion by paired-t test.   "
49624|NCT02636101|"     This study aims to describe the patient population treated and the real-life patients'     experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis     vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling     dermatologists and patients to optimize its use in the long term management of psoriasis.   "
49625|NCT02636088|"     In patients with esophageal cancer, treatment with curative intent can be given to medically     fit patients without distant metastases. It may consist of chemoradiotherapy or surgery alone     or in combination. Surgery in combination with chemotherapy is another option. For patients     who are not medically fit for surgery or with unresectable invasion in adjacent structures     the only alternative with curative intent is, with current knowledge, definitive     chemoradiotherapy. In the current study the investigators aim to improve prognosis for     patients not suitable for surgery. Patients receive treatment with conventional     chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more     recently developed drug, an antibody called cetuximab.   "
49626|NCT02636075|"     This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward     in Parathyroid Hyperplasia Cases or not.   "
49627|NCT02636062|"     This study is a non-randomized prospective cohort study that will define the rate of index     atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC) score     of 0 given prior CAC zero > 5 years previous. Ancillary testing of serum, whole blood, and     endothelial dysfunction will be performed to investigate any detectable systemic processes     that predict CAC development.   "
49628|NCT02636049|"     This is a Phase 1, open-label, three-period sequential dosing study being conducted to     determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy     adults.   "
49629|NCT02636036|"     This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered     in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with     focus on CRC, UCC, SCCHN and salivary gland cancer) not responding to standard therapy.   "
49630|NCT02636023|"     The study Sponsor, Heart Force Medical Inc. (HFM), has developed a patented medical device     called the SPhENo-CardiographTM. The SPhENo-Cardiograph™ provides a non-invasive assessment     of the electro-mechanical function of the heart. The electrocardiograph (ECG) represents the     waveform of the electrical stimulus to the cardiac muscle. The mechanical actions of the     electrical potentials delivered in the ECG are revealed as the seismocardiograph (SCG). The     SCG represents the changes in acceleration of the heart during the cardiac cycle. The SCG     waveform reflects the ultra-low frequency vibrations of cardiac contraction. These low     frequency vibrations are transmitted through the sternum. Using the point of initiation of     ventricular contraction on the ECG, the Q wave, with fiduciary points on the synchronous     seismocardiograph, it is possible to determine timing events of the cardiac cycle. The timing     events of the cardiac cycle during systole are referred to as Systolic Timing Intervals (STI)     and comprise the Pre-Ejection Period (PEP) and the Left Ventricular Ejection Time (LVET). The     PEP is the time from the Q wave to the Aortic valve opening. The Left Ventricular Eject Time     (LVET) is the time between the Aortic Valve opening and closing. The ratio of PEP/LVET in     individuals with established heart disease is > 0.42. It is based on the formula described by     Dr Arnold Weissler and first published in Circulation in 1968 (Weissler et al,1968). Weissler     et al showed that the PEP/LVET ratio >0.42 are indicative of a lengthening of the PEP with     some marginal shortening of the LVET. This is indicative of pathology associated with the     coronary circulation (Ahmed et al, 1972;). This ratio can then be used as part of a     non-invasive quantitative assessment of cardiac performance (Lewis et al 1977).      Using the SPhENo-CardiographTM, HFM has developed an algorithm to assess heart health that     otherwise requires a number of technologies; stethoscope, ECG and Carotid pulse tracing to     identify the dicrotic notch or Aortic Valve closure.   "
49631|NCT02636010|"     This is a national, multicenter, open label single-arm, non-comparative study that will     determine the efficacy, safety and the changes in selected pharmacodynamics markers of     MK-3475 monotherapy administered as consolidation therapy in MM patients who have achieved a     response with a previous treatment but who still display some residual disease.      For this purpose, 20 MM patients, who have received any treatment of limited duration either     at diagnosis or at first relapse, and that have achieved a good response (≥VGPR) but with     persistent residual disease (that is patients in VGPR, non-stringent CR, or MRD+ sCR), will     be treated with MK-3475 monotherapy administered iv at a dose of 200 mg every three weeks for     1 year, with a potential expansion of 1 additional year of treatment in case of clinical     benefit and patient agreement. Efficacy, safety and pharmacodynamic parameters will be     evaluated to understand the role of this monoclonal antibody in this setting.   "
49632|NCT02635997|"     Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by     several international, randomized, double-blind, controlled trials. These studies have not     included patients from central america, to the best of our knowledge. Therefore, this     open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment     course with Ibandronate plus vitamine D and Calcium on bone mineral density and     health-related quality of life.   "
49633|NCT02635984|"     The objective of this study is to compare the effectiveness of olanzapine added to standard     triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone     in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients     receiving highly or moderately emetogenic chemotherapy regimens.   "
49642|NCT02635867|"     At present, dentistry aims for conservative treatments with the goal of maintaining as much     tooth structure as possible. Dental caries remains the most prevalent chronic disease     worldwide; these lesions can progress rapidly and reach deeper areas of the tooth. The     carious lesion is considered deep when it goes through the main tissues of the tooth, and it     can affect the pulp tissue, where the nerve and nutrients of the tooth are located. There are     many treatment options for deep carious lesions and they vary by the clinical scenario. Vital     pulp therapy has become a fairly predictable alternative treatment to pulpectomy (root canal     therapy). The goal of vital pulp capping therapies is to keep the pulp of the teeth vital to     prevent further interventions such as root canal treatments and complex restorative work.     There are two main clinical scenarios when treating these lesions, depending on the remaining     dentin thickness between the carious lesion and the pulp: vital direct and indirect pulp     capping. Direct and indirect vital pulp therapies are routinely performed using different     clinical protocols. The clinical protocols are selected based on the remaining dentin     (between the tooth preparation and pulp) and the restorative materials. There are few studies     that evaluate pulp capping method in adult teeth (permanent dentition); many studies have     investigated baby teeth (deciduous teeth). Routine therapies include the using of adhesive     restorations with and without an intermediate layer of restorative material. Calcium     hydroxide based cements have been used for pulp capping as an intermediate layer of     restorative material. More recently a new intermediate layer of restorative material composed     of resin-modified calcium silicate has been indicated for use on direct and indirect pulp     capping. The aims of this study are to compare, over a period of 12 months, the     post-operative sensitivity and pulp vitality of three indirect pulp capping protocols and two     direct pulp capping protocol in vital teeth. This study will provide the necessary evidence     to allow clinicians to select the best restorative protocol when treating deep carious     lesions where indirect and direct pulp capping protocol are needed.   "
49643|NCT02635854|"     Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic     shock in mice and human models. Platelets are actors in immunity and their activation can be     complicated by tissue damage with vascular occlusions which can lead to organ dysfunction.     Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet     aggregates in septic shock.   "
49644|NCT02635841|"     Patients with pantothenate kinase-associated neurodegeneration (PKAN) who have completed the     ApoPharma-sponsored study TIRCON2012V1-EXT and who wish to continue to take deferiprone will     be offered the opportunity to receive it on a compassionate basis. Patients will be followed     locally by their own neurologist or other appropriate specialist.   "
49645|NCT02635828|"     Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical     patients during the first 24 hours after a surgical procedure. The incidence of postoperative     nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in     high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of     this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a     triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV     in patients undergoing craniotomies under general anesthesia.   "
49646|NCT02635815|"     Background & Aims: Non-cirrhotic portal hypertension (NCPH) represents a relatively     infrequent group of conditions. This work aimed at determining causes of NCPH and evaluating     the role of some clinical, laboratory, imaging and endoscopic parameters in prediction of     variceal bleeding in an Egyptian cohort with NCPH.      Methods: Sixty patients with non-cirrhotic portal hypertension and oesophageal varices were     included. All underwent complete clinical evaluation, laboratory investigations, Color     Doppler ultrasonography, platelet count/spleen diameter (mm) ratio and upper gastrointestinal     endoscopy. Patients were classified into two groups according to variceal bleeding: (1) Group     I: twenty six patients with history of bleeding or had an attack of bleeding during one year     follow-up; and (2) Group II: thirty four patients without bleeding.   "
49647|NCT02635802|"     Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset     and short lasting duration. Remifentanil usually is used to help reducing the pain of     patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in     ICU small short time operation.The purpose of this study is to determine (1) whether     remifentanil is effective in small short time operations in ICU or not, (2) the save range of     remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens     in these operations.   "
49648|NCT02635789|"     The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical     formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in     patients with tuberous sclerosis complex (TSC)   "
49649|NCT02635776|"     The purpose of this study is to demonstrate the efficacy and safety of AR101 through     reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.   "
49650|NCT02635763|"     As the population ages, the frequency of surgery is increasing proportionally, bringing with     it the challenge of managing older patients with frequent comorbid diseases and an increased     risk of complications. Poor postoperative quality of recovery may result in patient and     family suffering, a prolonged hospital stay, and a greater demand on health care     resources.The purpose of this study was to evaluate the ultrasound guided percutaneous     femoral nerve+lateral cutaneous nerve versus lumbar plexus+sacral plexus nerve block     composite laryngeal mask anesthesia in elderly hip fracture surgery, the application of     assessing their impact on the postoperative recovery quality.   "
49653|NCT02635724|"     This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of     600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza     infection and in subjects with acute uncomplicated influenza infection at higher risk for     influenza complications. All subjects will receive IV peramivir.   "
49654|NCT02635711|"     Objectives: To evaluate the effects of a novel adapted Taekwondo (TKD) training programme on     skeletal development and motor proficiency in pre-pubertal children with developmental     coordination disorder (DCD).      Hypothesis: The TKD group participants will have improved skeletal development and motor     proficiency outcomes after adapted TKD training compared with the controls.      Design and subjects: In this prospective, randomised, single-blinded controlled trial,     approximately 104 children with DCD (6-9 years old) will be randomly assigned to either the     adapted TKD group (n~52) or the control group (n~52).      Interventions: Subjects in the intervention group will receive adapted TKD training for 3     months (one supervised session/week plus daily home training, 1 hour per session), while     subjects in the control group will receive no TKD training during the study period.      Study instruments and outcomes: Primary outcome measures: delay in skeletal development and     motor proficiency will be measured by an ultrasonic bone age system and the Movement     Assessment Battery for Children, respectively. Secondary outcome measures: eye-hand     coordination and standing balance will be measured by a computerised finger pointing test and     the Sensory Organisation Test, respectively (pre-, post- and follow-up measurements).      Data analysis: Data will be analysed via repeated-measure analysis of (co)variance followed     by post-hoc tests, if appropriate (alpha = 0.05).   "
49658|NCT02635659|"     Intraileal infusion of nutrients results in a reduction in food intake. A previous study by     our group showed that both sucrose and casein infusion resulted in an increase in satiety and     release of gastrointestinal peptides and a decrease in hunger and food intake. Encapsulating     both nutrients, daily ingestion of this micro encapsulate and hereby releasing them in the     distal small intestine could result in a chronic ileal brake activation. The obtained     reduction in food intake and caloric intake could help overweight subjects to lose weight.   "
49659|NCT02635646|"     The purpose of the study is to evaluate the effect of a family and interdisciplinary approach     on individual and family insulin resistance and insulin secretion in patients with     prediabetes.   "
49660|NCT02635633|"     The purpose of this study is to investigate a novel stimulation protocol of repetitive     transcranial magnetic stimulation (rTMS) for the treatment of unifocal neocortical epilepsy,     namely continuous thetaburst stimulation (cTBS). As this is a pilot study, the primary     endpoint is on safety and tolerability of the treatment. However, information on clinical     efficacy and mechanism of action will also be collected.   "
49661|NCT02635620|"     The purpose of this study is to investigate whether changing from conventional smoking to     electronic cigarettes causes changes in conventional lung function parameters, bronchial     reactivity, fractional exhaled nitric oxide (FeNO), Carbon monoxide (CO), health effects and     smoking behaviour.   "
49662|NCT02635607|"     The purpose of study is to compare the effectiveness of the Day-5 fixed administration of     GnRH antagonist versus flexible administration of GnRH antagonist during ovarian stimulation     in Chinese women with predicted high ovarian response, and the hypotheses is that the number     of oocyte retrieved in fixed protocol is not inferior to GnRH antagonist flexible protocol.   "
49663|NCT02635594|"     Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and     parameters of recovery after physical exertion.   "
49664|NCT02635581|"     The purpose of this clinical trial is to evaluate the osteointegrative potential of the     Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD)     around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months     after surgery.   "
49681|NCT02635360|"     The purpose of this study is to evaluate the safety and effectiveness of immunotherapy in     combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced     cervical cancer. Pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will     be administered after or during chemoradiation.   "
49666|NCT02635555|"     At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a     short acting opioid fentanyl (to increase block density) and a long acting opioid morphine     (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean     section.However, larger doses of local anesthetic drug when used in caesarean section     commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our study     the investigators will standardize the doses of both opioids (fentanyl/morphine) and adjust     the dose of local anesthetic (bupivacaine) based on the patients height and weight .One of     the obvious challenges anesthesiologists face is providing adequate anesthesia to the patient     whilst minimizing harmful side effects. Our primary concern is the low blood pressure as an     effect of the spinal anesthetic as it is harmful to both mother and the baby. The     investigators propose that the extent of surgical anesthetic block, which is dependent on     height and weight in our adjusted dose group, will provide adequate anesthesia for surgery     and minimise maternal low blood pressure.   "
49667|NCT02635542|"     The investigators will conduct a prospective, randomized trial to assess the impact of     neuromuscular blockade on early (<72 hours post-ICU admission) postoperative respiratory     complications in cardiac surgical patients. The study will compare continual neuromuscular     blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for     cardiac surgery.   "
49668|NCT02635529|"     Amniotic membrane may be considered as a biologically active scaffold, which in combination     with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony     Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the present     study was to evaluate if a biologic AM in combination with DFDBA applied in periodontal IBDs     would enhance the regeneration of periodontium.   "
49669|NCT02635516|"     This is a proof-of-concept study designed to demonstrate whether increases in cerebral blood     flow, improvements in brain functioning, and reductions in symptomology associated with     traumatic brain injury (TBI) can result from treatments consisting of near-infrared     phototherapy (NIR).   "
49670|NCT02635503|"     The purpose of this study is to compare the safety and efficacy of laparoscopic resection     with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid     colon or rectal cancer.   "
49671|NCT02635490|"     The present study aims to investigate the relative efficacy, safety and risk of a single-dose     prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for     ureteral stones.   "
49672|NCT02635477|"     A multicenter prospective randomized clinical trial testing the hypothesis that a     patient-centered actigraphy intervention will result in increased physical activity for frail     older adults increase during the critical first 30 days after a cardiovascular     hospitalization.   "
49673|NCT02635464|"     The study is designed to assess the safety and efficacy of allogeneic human umbilical     cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted     into patients with chronic ischemic cardiomyopathy.   "
49674|NCT02635451|"     To study the association between maternal serum vitamin C concentration in women with preterm     premature rupture of membranes (PPROM) and women without PPROM.   "
49675|NCT02635438|"     The objectives of this study are to compare the efficacy and safety of Clotrimazole troche/     lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) vs. Clotrimazole Troche/     Lozenges USP, 10 mg (Roxane Laboratories Inc., USA) in patients with oropharyngeal     candidiasis, where this condition has been diagnosed by clinical examination and confirmed by     fungal culture   "
49676|NCT02635425|"     The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve     7eggs only in prevention of severe ovarian hyperstimulation syndrome.   "
49678|NCT02635399|"     Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most     important modality in the treatment. In the past, pancreaticoduodenectomy was associated with     high morbidity and mortality. However, with the advances in techniques, including     perioperative patient management, development of antibiotics, diagnostic radiology, and     interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible     operation. Postoperative complication rates are reported to be in 10 to 20% in experienced     hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for     periampullary cancer is actively considered.      However, postoperative complications, such as postoperative pancreatic fistula, (POPF)     delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still     serious complications. Among these complications, delayed gastric emptying is considered less     critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in turn,     may lead to delay in recovery of postoperative nutritional state and in severe cases,     requires insertion of levine tube and long-term fasting.      There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite     cause have not been discovered yet. With the introduction of pylorus-preserving     pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased.     However, results of most randomized comparative studies had concluded that PPPD and PD have     no significance in occurence of DGE.      One hypothesis for cause of DGE we present here has to do with anatomic positioning of     anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after     PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often     associated with one of postoperative complications, POPF. POPF may create inflammation around     PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary change.     This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled towards     PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and gastric     contents may not beadle to pass easily. Gastric contents may be stagnated in stomach and     thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon using     sutures, and prevent possibility of angulation of DJ. This additional procedure may reduce     occurence of DGE.   "
49679|NCT02635386|"     This is a randomized, single-blind, parallel 5 treatment group 24-week trial designed to     directly compare the therapeutic effects of exenatide once weekly (EQW), dapagliflozin     (DAPA), EQW plus DAPA, combined DAPA/metformin extended release (XR) and the weight loss     medication, phentermine/topiramate extended release (PHEN/TPM ER) on metabolic and     endocrinological parameters in overweight/obese non-diabetic women with PCOS. In this study,     we will examine the efficacy of these therapies on metabolic parameters, body weight and body     composition, anthropometric measurements, and reproductive function in a well-defined group     of pre-menopausal overweight/obese, non-diabetic women with PCOS, focusing on their     relationship to insulin resistance and obesity. We hope to determine which treatment(s)     addressing the multifaceted disturbances of individual subgroups emerge as the preferable     therapy.   "
49680|NCT02635373|"     Observational, registry, prospective, non-interventional collection of CUA patient data.     Patient treatment is carried out within clinical routine, at the discretion of the physicians     and according to existing treatment guidelines. Participating physicians will not be subject     to any instructions with regard to the diagnosis and therapy of their patients.   "
49682|NCT02635347|"     This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic     Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver     Transplantation (OLT). Remote ischemic conditioning will consist of 3 cycles of 5 minutes of     lower limb ischemia induced via a mid-thigh pneumatic tourniquet, followed by 5 minutes of     reperfusion. Interventions will take place after anesthesia induction but before surgery, at     the completion of the procedure, and on the mornings of post-operative days 1-4.   "
49683|NCT02635334|"     This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years     old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the     treatment of asthma in subjects who are 12 month old and older. This study is being done     because there has been no placebo controlled study of montelukast focused on this group of     patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely     to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger     asthmatics. The pathophysiology of asthma in the elderly is typically different than in     younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators     plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are     non smoker, and did not smoke for more than 10 pack/year of tobacco products in their     lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg     orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of     this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily     symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric     values (FEV1). Secondary objectives include studying whether montelukast affects peripheral     blood eosinophils counts and serum IgE levels.   "
49684|NCT02635321|"     Limb girdle muscular dystrophies (LGMD) are a very heterogeneous group of muscle disorders     characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and     pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into     more than 31 different types.      A new type - type 2T has been found. The genetic cause of type 2T is mutations in Guanosine     Diphosphate (GDP)-mannose pyrophosphorylase B (GMPPB). Mutations in GMPPB can also cause     Congenital muscular dystrophies (CMD). Only 41 patients with mutations in GMPPB has been     reported.      In this study, the investigators examine five new cases with the LGMD phenotype. The primary     aim is to examine the muscle involvement using MRI.   "
49685|NCT02635308|"     This study evaluates the feasibility of implementing a unilaterally biased high-intensity     resistance training to facilitate restorative vs. compensatory recovery after usual care     physical therapy among older adults who have recently incurred a hip fracture. Additionally,     physical performance during a sit-to-stand task, muscle function (strength/power), physical     function measures, muscle composition, and muscle quality (force/unit area), are assessed     before and after targeted high-intensity resistance training.   "
49686|NCT02635295|"     The aim of this study is:        1. to evaluate the effectiveness of the nursing student - nurse teacher mobile cooperation          (MC) during the clinical practicum,        2. to measure the usability of the mobile application.      The detailed research questions and hypothesis of this study are as follows:        1. What is the impact of MC on the nurse competence level of nursing students evaluated by          work role, teaching-coaching and therapeutic interventions?           H1: Nursing students' using MC will have a stronger change in the self-assessed level of          nurse competence than those using standard cooperation (SC).           H2: Nursing students' using MC will have higher level of nurse competence assessed by          mentors after clinical practicum than those using SC.        2. What is the impact of MC on the clinical self-efficacy level of nursing students?           H3: Nursing students' using mobile cooperation will have a stronger change in the          self-assessed level of self-efficacy in clinical performance than those using standard          cooperation.        3. What is the impact of mobile cooperation on the satisfaction level of nursing students          evaluated by supervisory relationship, pedagogical atmosphere on the ward and the role          of nurse teacher?           H4: Nursing students' using mobile cooperation will have higher level of satisfaction          with the supervisory relationship, pedagogical atmosphere on the ward and the role of          nurse teacher after clinical practicum than those using standard cooperation.        4. What is the perceived usability of the mobile application by the intervention group?      The ultimate goal is to establish a modern, innovative solution for the nursing student -     nurse teacher cooperation to support and facilitate the clinical learning of nursing students     during the clinical practicum.   "
49687|NCT02635282|"     The general objective of this study is to determine whether intranasal ketamine should be     incorporated into formulary as an option to treat pain during minor procedures in the     pediatric emergency department.   "
49689|NCT02635256|"     Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe     and feasible.      Investigators initiated this multicenter phase II prospective trial to analyse feasibility     (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised     prostate cancer, who are ineligible for the PREFERE trial under the hypothesis that the     ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant     lower than 17.5%.   "
49690|NCT02635243|"     Primary Objective:      To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544     versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced     hypoglycemia.      Secondary Objective:      To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of     SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia.   "
49691|NCT02635230|"     The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a     CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by     percutaneous coronary intervention (PCI) with stenting, is still unknown. For these patients     current North American and European guidelines recommend a triple therapy strategy, including     vitamin K antagonists (VKA), aspirin and clopidogrel. A major drawback of this triple therapy     strategy is a significant increase in the risk of major bleeding. Furthermore, the ommitance     of aspirin and the introduction of more potent P2Y12 inhibitors as well as the non-vitamin K     oral anticoagulants (NOAC), created numerous new antithrombotic treatment strategies for     these patients with overlapping conditions. To date, evidence on the risks and benefits of     these new antithrombotic treatment strategies is lacking.      The WOEST 2 Registry aims to improve medical care for patients with AF and/or a heart valve     prosthesis ánd undergoing coronary revascularisation through a better understanding of their     demographics, antithrombotic management and related in-hospital and long-term outcomes. The     WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment     patterns and patient outcomes.      Objective: To assess the different management patterns and related in-hospital and long-term     safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12     inhibitor in patients with atrial fibrillation and/or a heart valve prosthesis undergoing     coronary revascularisation.   "
49692|NCT02635217|"     Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies     (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of     patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a     video camera on the end). An EGD is performed to examine the upper digestive tract to look     for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube,     stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the     large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining.      During these procedures, room air is routinely used to insufflate (expand/inflate the stomach     and the colon) to allow for better viewing of the lining of the upper and lower     gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air)     has been shown to possibly have less post-procedure patient discomfort. Additionally, when     both procedures are performed in the same day, it is currently unknown as to which sequence     of procedures is better overall -whether to perform the EGD before colonoscopy or vice versa.      The overall aim of our research is to compare patients' comfort, total amount of sedation     used, and overall satisfaction with the procedures between four randomly allocated groups, to     see which method of insufflation and which procedural sequence is better when both procedures     need to be performed in the same day. We hypothesize that in patients requiring same day     endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an     insufflator is the best tolerated sequence associated with decreased sedation use and     increased patient satisfaction/comfort.   "
49693|NCT02635204|"     This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical     treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.   "
49694|NCT02635191|"     This study is designed to compare the eradication rates，safety and compliance of tailored     therapy to those of standard triple therapy in children with H. pylori infection. The primary     purpose is to compare the eradication rates of children with H. pylori infection treated with     tailored therapy to those treated with standard triple therapy. The secondary purpose is to     evaluate the safety, compliance and factors that might affect eradication rates.   "
49695|NCT02635178|"     Obsessive-compulsive disorder (OCD), characterized by recurrent obsessions and/or     compulsions, is a disabling psychiatric condition affecting approximately 2-3% of the     population. Whereas several first-line treatments have been established (e.g.,     pharmacological and psychological), a substantial proportion of patients (40-60%) fail to     experience symptom remission, underscoring the need for research in this area. One approach     to increasing treatment efficacy is to target underlying risk factors or dysfunctions that     may in turn improve outcomes. One such risk factor is anxiety sensitivity (AS) cognitive     concerns. AS cognitive concerns reflects fears of mental incapacitation (e.g., It scares me     when I am unable to keep my mind on a task). There is recent evidence that AS cognitive     concerns is uniquely associated with various obsessive-compulsive (OC) symptom domains.     However, questions remain as to whether reductions in AS cognitive concerns will lead to     subsequent reductions in OC symptoms. The purpose of the proposed study is to investigate the     efficacy of a brief AS cognitive concerns intervention on reductions in OC symptoms.   "
49696|NCT02635165|"     Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by     decreasing the length of stay and the late complications: pain chronicles, quality of life,     respiratory function   "
49697|NCT02635152|"     The purpose of this study is to determine whether a computerized intervention designed to     reduce appearance and evaluation related interpretation biases will reduce symptoms     associated with body dysmorphic disorder.   "
49698|NCT02635139|"     Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping)     on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate     intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch,     dinner) serves as a control.   "
49729|NCT02634710|"     This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and     disease control (local control, overall and progression-free survival) using hypofractionated     preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).   "
49699|NCT02635113|"     The purpose of this study is to develop an abnormal gait detection algorithm and a vibratory     stimulation system on a lower limb to improve gait stability and prevent falls. The     investigators want to detect, assess and communicate fall risk indicators obtained via the     shoe sensors, and assess effectiveness of a gait synchronized vibration system to the plantar     surface in reducing fall risk.The system consists of a gait measurement module, an abnormal     gait detection module, and a vibratory stimulation module.   "
49700|NCT02635100|"     Obstructive sleep apnea (OSA) is a prevalent disorders characterized by intermittent     obstructions of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) has     been shown to be the most efficacious treatment for OSA. It consists of a small device that     provides positive airway pressure delivered by a mask attached to the patients nose/mouth.   "
49701|NCT02635087|"     The investigators discover the investigators' miRNA tool can be a useful tool to predict the     patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to     make an observation study that may validation this tool.   "
49702|NCT02635074|"     This phase I trial studies the side effects and best dose of ibrutinib when given together     with idarubicin and cytarabine in treating patients with acute myeloid leukemia that has     returned after a period of improvement or has not responded to previous treatment. Ibrutinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving ibrutinib together with idarubicin and cytarabine may     kill more cancer cells.   "
49703|NCT02635061|"     Determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated     dose (MTD) of ACY 241 in combination with nivolumab.   "
49720|NCT02634827|"     This phase II trial studies how well midostaurin and decitabine work in treating older     patients with newly diagnosed acute myeloid leukemia and FLT3 mutations. Midostaurin and     decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth.   "
49801|NCT02633956|"     This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an     open-label LTSE, will evaluate the effect of Obeticholic Acid, and the subsequent addition of     statin therapy, on lipoprotein metabolism in subjects with NASH with fibrosis stage 1 to 4,     but no evidence of hepatic decompensation.   "
49704|NCT02635048|"     Percutaneous nephrolithotomy (PCNL) has been considered as the first-line choice for the     management of >20mm kidney stones. The traditional nephrostomy tract of PNL was dilated to     24-30F, which is referred to as Standard-PCNL. Standard PNL has an ideal stones free rate     (SFR), however, at the cost of severe morbidity. To decrease the disadvantages related to     standard PNL, mini-perc or mini-PCNL, 20F or less, was first introduced to pediatric     procedure in 1997, and subsequently implemented in adults with the expectation of similar SFR     and low morbidity in the past twenty years. Although abundant efforts have been done, whether     mini-perc outweigh standard-PNL for the treatment of >20mm calculis in terms of efficiency     and safety remains controversial.      To solve this problem, we performed this multi-center randomized controlled trial (RCT).   "
49705|NCT02635035|"     The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With     Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a     placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day     in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT).     Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout     period.   "
49706|NCT02635022|"     Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan     Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch.      Method: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the     Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital     Jinshan Branch health care system. The Jinshan Branch program enrolled patient with 1) new     hip fracture 2) newly identified vertebral fractures (radiological or clinical) from both     inpatients and outpatients. At the same time, a osteoporosis medication management service is     also establish as a complement of FLS to enroll patients on antiosteoporosis medications     (AOMs) but not necessary with fracture.      Participating physicians will select those eligible for services and refer to study     coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture     risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,     sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic     visit, telephone reminder and follow up for patients, and communicate with providers on     regular bases.      During the whole study period, the investigators planed to enroll 200 patients (with or     without fracture). Each patient would be assessed at baseline, and every 4 months last for     two years.   "
49707|NCT02635009|"     This randomized phase II/III trial studies how well whole-brain radiation therapy works and     compares it with or without hippocampal avoidance in treating patients with small cell lung     cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only     (limited stage) or has spread outside of the lung in which it began or to other parts of the     body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and     shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding     the hippocampus during whole-brain radiation could decrease the chance of side effects on     memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more     effective with or without hippocampal avoidance in treating patients with small cell lung     cancer.   "
49708|NCT02634983|"     The purpose of this study is to assess global ventilated lung volume in moderate to severe     COPD patients using MRI lung imaging after 8 days of treatment with QVA149 compared to     placebo.   "
49709|NCT02634970|"     There are limited prospective data regarding the potential benefit and risks associated with     switching between anti-VEGF therapies in patients with nAMD who have initially achieved a     favorable response to the first anti-VEGF therapy used but subsequently have evidence of     increasing disease activity despite continuation of therapy. This study will fill this     knowledge gap by prospectively evaluating the effectiveness and safety of switching from     aflibercept to ranibizumab in nAMD patients that have non - sustained response to initial     treatment with aflibercept.   "
49710|NCT02634957|"     Absolute voice rest is commonly prescribed after vocal fold surgery, also known as     phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of     vocal folds, which could result in increasing tissue stiffness and limitations in optimal     vocal outcome. Unfortunately there is no standardized protocol as to how long patients should     rest their voice after phonomicrosurgery. To date, there are no studies in the literature     directly comparing the impact of short-term and long-term voice rest on vocal fold healing     and voice outcome after phonomicrosurgery.   "
49711|NCT02634944|"     The purpose of the proposed project is to determine if the VOMS is an effective screening     tool to identify and track recovery of vestibular and ocular motor impairment and symptoms     following mTBI, that corpsman-level medical personnel can successfully implement in combat     and non-combat environments. A second purpose of the project is to determine if impairment     and symptoms on the VOMS is more pronounced following blast compared to blunt mTBI.   "
49712|NCT02634931|"     The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with     NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients with     tuberous sclerosis complex in the open-label trial.   "
49721|NCT02634814|"     The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for     the novel indication of treating neuromuscular activation in individuals with knee     osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to     improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced     rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating     underlying neuromuscular activation deficits. The investigators seek to use TENS to excite     neural pathways that immediately increase neuromuscular activation as well as cause sustained     improvements in neuromuscular activation and greater strength gains in knee OA patients     compared to traditional TE. The investigators will evaluate the effect of TENS+TE on muscle     strength, neuromuscular activation, gait biomechanics, physical function, physical activity,     self-efficacy of physical activity, self-reported quality of life, disability and pain. The     central hypothesis is that an enhanced TENS+TE intervention will lead to better clinical     outcomes, increased physical activity, and improved general health. The rationale for     conducting a small clinical trial, which demonstrates the feasibility and establishes the     preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the     development of a future larger clinical trial to establish the efficacy of an enhanced     rehabilitation strategy for knee OA. This hypothesis will be tested through two specific     aims: 1) to collect and report data on the feasibility of conducting a clinical trial to     evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only for treating     patients with knee OA in a clinical setting, and 2) to determine preliminary effects of a     4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength,     neuromuscular activation, gait biomechanics, physical function, physical activity,     self-efficacy of physical activity, self reported quality of life, disability, and pain in     knee OA patients. Posttests will be at 4 and 8-weeks following baseline.   "
49722|NCT02634801|"     The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric     acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque     psoriasis who are naive to systemic treatment.   "
49713|NCT02634918|"     Hemophilia is a bleeding disorder (deficiency of a blood clotting factor/ protein) resulting     in bleeding in joints and muscles. As patients continue to bleed into their joints they     develop progressive joint damage leading to joint contractures, disability and days missed     from work and school resulting in chronic debilitating pain and compromised quality of life.     Current therapy is the administration of the missing protein or factor concentrate on a     scheduled basis to prevent bleeding into the joints referred to as prophylaxis. This factor     concentrate is expensive ~ $ 3,000 - 6,000 per infusion/ week in a child weighing 20 kg     translating into $ 77,000 /yr for life. This regimen has been shown to be effective to     prevent joint bleeds but the timing is unclear and not based on adequate evidence. Currently     joint damage is diagnosed using MRI which is expensive and requires sedation in children < 6     yrs of age. Therefore there is a need for a user friendly tool such as a ultrasound to     monitor for the development of joint disease and tailor treatment based on an individual     child's needs. This would also enable differentiating a joint bleed from a soft tissue bleed     which present similarly and duration of treatment tends to be longer for a joint bleed.     Acharya et al have previously shown that ultrasound is comparable to MRI for the diagnosis of     hemophilic joint disease in hemophilia patients over the age of 6 years. However, the     diagnostic findings in children < 18 years with hemophilia on ultrasound is not well     defined(1).      The hemophilic synovium after repeated joint bleeds reveals the development of new vessels     which are fragile and contribute to recurrent joint bleeds. Acharya et al have previously     shown that angiogenesis, a process of new vessel formation is active in hemophilic synovium     and angiogenic markers were significantly elevated in hemophilic patients with joint disease     when compared to those without (2). Since ultrasound can detect these new vessel changes in     the hemophilic synovium in hemophilia patients with joint disease and hemophilia patients     with joint disease demonstrate elevated markers of new vessel formation these investigators     would now like to determine whether radiological findings of hemophilic joint disease     correlate with serological angiogenic markers. This may enable the development of biomarkers     for hemophilic joint disease.      Findings from this study will enable the development of ultrasound as a user friendly tool in     the hemophilia clinic in order to understand whether every pain and swelling in a joint is     actually a joint bleed or soft tissue bleed and to monitor for joint changes to institute or     augment scheduled factor infusions ( prophylaxis). This will also result in significant     improvement in quality of life with tailored prophylaxis .   "
49714|NCT02634905|"     -  Atopic dermatitis is a chronic relapsing disease, which is highly prevalent in children          (15%). Therapeutic patient education (TPE) has been recognized as a key priority topic          for future AD research. The strongest evidence in favour of TPE efficacy in AD comes          from a large study assessing repeated multi-disciplinary group education sessions in a          hospital setting. However, this type of intervention is both resource and time consuming          and is not adapted to typical French practice. However, in some french dermatology          centers, simple first level nurse-led TPE interventions are offered in addition to          physicians consultations. Unfortunately, the content of these interventions seems to          vary greatly depending on the caregiver and the center and the benefits of these          practices have not yet been assessed. Therefore, nurse-led TPE is not considered as          current care in France for AD patients.        -  Thus, there is a need to rigorously assess the benefits of additional, well-structured,          simple nurse-led individual TPE interventions for children with AD and their families          compared to standard care alone. This study will be the first large, adequately powered,          multicenter RCT trial assessing this type of intervention in children with AD.   "
49715|NCT02634892|"     Objective - To demonstrate the efficacy of the pressure redistributing cooling mattress     overlay compared to usual care in mitigating the progression of early pressure ulcers in     critically ill (ICU) patients via a prospective randomized human clinical trial.      Specific Aim - The clinical trial will evaluate the efficacy and safety of the PRO-TECT ™     mattress overlay in ICU patients who have already developed early pressure ulcers (Stage 1     and 2) and preventing further progression to more severe pressure ulcers (Stage 3 and 4) as     well as potential faster regression (i.e. healing of Stage 1 and 2 pressures).   "
49727|NCT02634736|"     This cluster RCT study will investigate the effectiveness of strength/balance Exergames     (exercise and computer games that use body movements as controls) developed to improve     balance, function, prevent falls and increase exercise adherence for older people in the home     setting. The proposal incorporates postural stability Exergames that have been developed with     users based on best evidence strength and balance exercise (OTAGO and Postural Stability)     currently used by therapists, safe for older people and can be used in the home setting   "
49728|NCT02634723|"     The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity,     and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to     severe hemophilia A.   "
49716|NCT02634879|"     The shift towards value-based reimbursement in U.S. healthcare is accelerating. Payment     reform initiatives have taken many shapes—accountable care organizations, bundled payments,     value-based purchasing, medical homes, global payment—but all share the common strategy of     tying provider (physician, hospital, health system) reimbursement to performance on costs,     outcomes, or both. Yet, pay-for-performance has demonstrated little effect on physician     behavior and patient outcomes. Payers and provider groups are in need of novel approaches to     structure provider incentives—both financial and non-financial—to better promote the delivery     of quality, cost-effective care. In this project, the study team plans to study how     behavioral economic principles can improve the effectiveness of physician incentives to     deliver higher quality and lower cost care. They will test the application of specific     behavioral economic principles including immediacy, social pressure, and loss aversion in     incentive design and implementation. The study will contribute to an empirical foundation for     re-design of existing physician incentive programs and implementation of new policies through     secondary data analyses and a multi-arm experiment that evaluate the impact of promising     behavioral economics principles on the effectiveness of provider financial and nonfinancial     incentives.   "
49717|NCT02634866|"     Arterial hypertension (AH) is an important clinical social and economic problem, related to     the increased cardiovascular risk. AH is associated with cardiovascular hemodynamic     alterations, including left ventricular diastolic dysfunction (LVddf). In consequence of     increased blood pressure, the effectiveness of LV as a blood pump decreases and the symptoms     of heart failure (HF) may occur. Thus, the identification of noninvasive markers related with     the progression from the asymptomatic AH to LVddf/HFpEF would be beneficial.      Another issue is that the diagnostic difficulties in patients with LVddf and HFpEF stem from     the limited possibility to assess the hemodynamic response to exercise. Thus, there is a need     for more detailed methods of cardiovascular monitoring while exercise testing.      We hypothesize that some new noninvasive hemodynamic parameters, characterizing left     ventricular (LV) function and arterial stiffness, may help to predict the risk of     cardiovascular events and future occurrence of LVddf/HFpEF. Moreover, we assume that     cardiopulmonary exercise test (CPET), completed with new methods of noninvasive hemodynamic     monitoring (impedance cardiography and applanation tonometry), would provide additional value     in the assessment of the cardiovascular hemodynamic response to exercise.      The study is intended to verify these hypothesis.   "
49718|NCT02634853|"     The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic     Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry     eye.   "
49719|NCT02634840|"     Several technical modifications based on the anatomical position of the neurovascular bundle     and its bony mandibular canal have been developed, aiming to prevent injury to the     intraalveolar nerve We hypothesized that the incidence of neurosensory disturbance (NSD)     should be reduced using our bilateral sagittal split osteotomy (BSSO) technique, because     direct intra-alveolar nerve injury can be avoided. The aim of this study was to introduce our     modified BSSO technique and evaluate the subsequent incidence of postoperative neurosensory     disturbance of the IAN.   "
49825|NCT02633644|"     The purpose of the ENDO-HF study is to determine the safety & performance of the Harmony     System for the treatment of heart failure   "
49724|NCT02634775|"     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases     in childhood resulting in a lifelong need for health care, and a 3 times decreased life     expectancy. In addition, they have important comorbidities that negatively impact on their     quality of life and integration in society, jeopardizing their future even after a potential     transplantation. Retention of uraemic toxins is accepted to play a major role in the     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,     there are currently no good tools to evaluate severity and monitor adequacy of treatment,     resulting in suboptimal management.      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide the     clinician with new diagnostic and therapeutic tools for the management of children with CKD,     based on the improved understanding of uraemic toxicity.      In UToPaed (part 1), the investigators will associate concentrations of a wide variety of     uraemic toxins with different comorbidities in CKD children, i.e. growth, protein-energy     wasting, quality of life, cardiovascular risk factors, circadian rhythm, sleep quality, and     psychosocial and neurocognitive functioning (i.e. cross-sectional and longitudinal). Those     toxins of which concentrations are best correlated with comorbidities during the progress of     CKD and those having representative kinetics (UToPaed - part 2: Kinetic analysis) will be     selected as markers. During this third part of UToPaed, these markers will be, together with     the comorbidities, further tracked after interventions, i.e. starting on dialysis,     transplantation, changes in dialysis strategy.      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations     will be developed to optimise and individualise the dialysis therapy.      By providing clinicians with more advanced and appropriate tools to improve management of all     children with CKD, i.e. better assessment of the degree of renal dysfunction, better     determination of the ideal time to start renal replacement therapy, and more accurate     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and     psychosocial functioning (short term), growth, maturation into puberty, and social     integration (median term) and survival (long term).   "
49725|NCT02634762|"     This prospective validation study evaluates the ability of a risk algorithm, which can     simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart     failure presenting to the emergency department. The risk algorithms for prediction of 7-day     (Emergency Heart failure Mortality Risk Grade [EHMRG]) and 30-day mortality (EHMRG30-ST) have     been previously derived.   "
49726|NCT02634749|"     Dietary factors during infancy, e.g. high intakes of protein, fast carbohydrates and     saturated fat increase the risk of adult obesity, type 2 diabetes and hypertension. However,     current dietary recommendations to infants are based on traditions and experiences whereas     research is basically lacking.      Towards the end of the first year of life the infant will normally become increasingly     suspicious towards fruits and vegetables. However, these foods are an important part of     healthy eating. When and how these food items should be introduced into the diet of young     children is unclear.      New Nordic Diet, an initiative from the Nordic Council of Ministers calls for a larger intake     of fruits, vegetables, whole grain, fish and game. In adults such diet improves weight and     biomarkers of insulin resistance and cardiovascular disease. Since dietary preferences are     founded early in life it is logical to introduce such a diet already when the child is     starting complementary foods.      In a randomized controlled study from 6 mo of age, we want to explore if a Nordic     complementary diet with lower protein intake, more vegetable fats and a systematic     introduction of fruits and greens will improve body composition, metabolic biomarkers, the     composition of faecal microbiota (associated with obesity), cognitive development and the     consumption of foods that can lay the foundation for better long-term diet. If the study has     the expected results, these will have a direct impact on the dietary habits of Swedish     children during infancy and childhood and thus their long-term health.   "
49730|NCT02634697|"     The purpose of this study is to determine if an eight week multimodal Relaxation Response     Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and     quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a     reduction in AF symptom score, perceived stress, anxiety, hostility and depression.   "
49731|NCT02634684|"     This application seeks renewed support for MH59803, Dopaminergic substrates of startle     gating across species, to extend a clear path of bench-to-bedside progress towards a     critical paradigm shift in therapeutic models for schizophrenia (SZ) and schizoaffective     disorder, depressed type (SZA): the use of Pharmacologic Augmentation of Cognitive Therapies     (PACTs). This novel therapeutic strategy for SZ/SZA directly addresses the need for more     effective treatments for this devastating disorder. MH59803 has investigated the neural     regulation of laboratory-based measures of deficient information processing in SZ/SZA     patients, using rodents and healthy human subjects (HS) to explicate the biology of these     deficits, and to establish a rational basis for developing novel therapies for SZ/SZA. In its     first 9 years, MH59803 studies of the neural regulation of prepulse inhibition (PPI) of     startle in rats focused on basic neurobiological and molecular mechanisms. Over the past 2     years of support, MH59803 studies moved from bench-to-bedside, focusing on dopamine (DA)     agonist effects on PPI and neurocognition in HS, and their regulation by genes identified in     cross-species studies. These studies detected biological markers that predict PPI-enhancing     and pro-cognitive effects of the DA releaser, amphetamine (AMPH) in humans, leading to     specific predictions of AMPH effects on PPI, neurocognition and Targeted Cognitive Training     in SZ/SZA patients. If confirmed in the present application, these predictions could help     transform therapeutic approaches to SZ/SZA. This renewal application of MH59803 thus reflects     a logical progression of studies at systems and molecular levels, translated first to HS, and     now to potentially transformative therapeutic models in SZ/SZA patients.   "
49732|NCT02634671|"     Background:      The present study aims to identify the mechanisms underlying the deficit in facial emotion     recognition reported both in schizophrenia and the 22q11.2 deletion syndrome, and thus,     reveal a distinction between the two disorders. Indeed, despite the clinical overlap between     the two syndromes, some of the symptoms appear to be specific to only one of them. In     particular, the disturbance of visual functions is specifically observed in the 22q11.2DS.     Hence, the difficulties in facial emotion recognition in schizophrenia and in the 22q11.DS     are likely accounted by different cognitive impairments. Investigating which mechanisms are     disturbed would allow a specialized support for patients.      Our main hypothesis is that the deficit in facial emotion recognition is more related to     visual impairments in the 22q11.2DS than in schizophrenia. This hypothesis will be tested in     two groups of patients (22q11.2DS and schizophrenic patients) and a control group (healthy     subjects) using an experimental paradigm based on electroencephalography (EEG).      A second aim of this study is to determine whether the severity of the two disorders'     symptoms is correlated with the cerebral response to facial expressions. To answer this     question, a set of clinical and neuropsychological tests will be conducted for each patient.   "
49733|NCT02634658|"     This study plans to learn more about whether simpler diagnostic tests can be used to identify     the development of acute neuromuscular loss of function in patients with critical illness and     respiratory failure receiving mechanical ventilation. ICU patients admitted to the University     of Colorado Hospital will be screened for eligibility and enrollment in the study to receive     weekly measurements of nerve and muscle function through nerve conduction studies (NCS),     muscle ultrasound tests, and concentric needle electromyography (EMG) tests.   "
49734|NCT02634645|"     A prospective outcomes study in patients with and esophageal cancer (EAC) and Barrett's     esophagus (BE) associated neoplasia being evaluated for endoscopic eradication therapy (EET).   "
49735|NCT02634632|"     Legitimized by the Leonetti law of April 22, 2005, advance directives (AD) appear in various     places of care that alongside the end of life, and even tend to be generalized to all areas     related to health care in general. In this context, a prospective study to assess how the     patient will seize the AD and identify the different problems writing these AD will be     conducted. From this study, it will establish recommendations for the implementation of AD in     the Multidisciplinary Oncology Department and Therapeutic Innovations service and in oncology     in general. They will be asked patients if they choose to write their AD, complete and sign     the AD pre-written in the book or not to draft their AD. The choice of the patients, but also     the reasons they associate thereto and, where appropriate, their AD written will be     collected. The patient will also inform its demographic and socio the case report (clinical     data) should be completed by the investigator. During the first part of research, the use of     AD by patients and will be assessed and analyzed in connection with the characteristics of     these patients (history of the disease, course of care, socio-demographic) and the reasons     they set out to explain their choice. For those who write their AD, they will, in a second     step, subject to thematic content analysis to identify the main aspects that the subject     convened to consider its end of life.This research therefore lead to the definition of the     contours of a user device AD in oncology in general. This study was qualified biomedical     research because of the sensitive nature of the study population and bring the patient to     personal preoccupations when filling the questionnaire on the choice of directing advance     directives and their contents.   "
49736|NCT02634619|"     The investigators propose a randomized non-blinded comparison of dorsal vs. ventral approach     for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common     method of repairing the strictured urethra. Current evidence suggests the two approaches for     placement of the graft are equally successful at correcting the stricture and the two     approaches have similar risks of complications. The investigators propose to randomly assign     appropriately selected patients to either a dorsally- or ventrally-placed graft. No     additional procedures beyond normal care protocol will be required of the patients. Success     will be assessed via objective and subjective methods; complications will be tallied in a     standardized fashion. Outcomes will be measured at two years.   "
49784|NCT02631941|"     The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in     comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence of     the two products. Namely the study will compare the total systemic bioavailability (as an     indicator of safety), and it will compare the pulmonary bioavailability (as a possible     surrogate indicator of efficacy). This study will be performed in healthy subjects.   "
49737|NCT02634606|"     Elevated blood cholesterol, and particularly LDL cholesterol, is a risk factor for heart     disease. Tocotrienols are naturally-occurring compounds in foods that may have beneficial     effects on blood cholesterol. Tocotrienols are members of the vitamin E family, and are found     in barley, oats, rye, coconut oil and rice bran oil, but the richest source of tocotrienols     is palm oil. Certain of these tocotrienols have been shown to be effective in lowering LDL     (or 'bad') cholesterol, with no adverse effects on the HDL (or 'good') cholesterol. The     purpose of this study is to determine the effects of a palm-oil derived tocotrienol     supplement on blood cholesterol, and particularly LDL cholesterol, in individuals who are     taking statins, and have either elevated or normal cholesterol levels. Study subjects will     consume a palm-oil derived supplement of tocotrienol for 3 months to determine its effects on     LDL cholesterol.   "
49738|NCT02634593|"     Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and     for obesity and comorbid metabolic disease in the offspring. Results of previous intervention     studies designed to improve the metabolic health of obese mothers, and thereby reduce the     risk to their offspring, have been modest at best. Furthermore, few studies have proved to be     efficacious among low income African American women who have high risk for the transmission     of obesity to future generations. The purpose of this study is to examine the feasibility of     changing the types of foods and drinks that are consumed at night during late pregnancy in     order to improve maternal glucose tolerance and reduce the risk for future obesity in the     child.   "
49739|NCT02634580|"     The primary hypothesis is that evolocumab (AMG 145) SC will be well tolerated and will result     in greater reduction of LDL-C than ezetimibe.   "
49740|NCT02634567|"     Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of     attention problems will be randomized to standard medical care (treatment as usual) or     attention training, which will be completed at their home using a commercially available     attention training task (Cogmed Working Memory Training - CWMT) for 5 weeks. Patients will     undergo cognitive testing before and after intervention and at 6 months follow up.   "
49741|NCT02634541|"     Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the     spine and the sacroiliac joints. Inflammatory pathways are likely the central link from axial     spondyloarthritis to the known increased risk of atherosclerotic morbidity. Positron emission     tomography (PET) is the most sensitive method to detect inflammatory foci in clinical     practice. A few small studies have demonstrated that PET imaging together with computed     tomography (PET/CT) detects inflamed tissues in relevant patient groups. One study suggested     that antirheumatic treatment diminishes the inflammation detected in PET/CT. No study so far     has disclosed whether aortic inflammation is present in patients with spondyloarthritis, and     whether the inflammation would wane with efficient antirheumatic treatment. The current study     is aimed to grade the articular and aortic inflammatory signals in the PET/CT imaging before     and after antirheumatic treatment of clinically active axial spondyloarthritis.      Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as     detected either by MRI or X-ray will be recruited. Twenty of those are DMARD-naive, and 40     patients have axial spondyloarthritis resistant to sulfasalazine or other conventional     antirheumatic drug. In addition, approximately 30 patients without spondyloarthritis but with     stable coronary heart disease and approximately 20 healthy controls will be taken as     historical controls. All the axial spondyloarthritis patients are PET/CT scanned after     inclusion in the study. The DMARD-naive patients (n=20) are started sulfasalazine-based     regimen for 12 weeks, which is the time point for a second PET scan for this subgroup.     Adalimumab will be commenced for those without remission at 12 weeks. After another 16 weeks,     those with adalimumab will be scanned with PET/CT for the third time. The subgroup with     active disease in spite of prior conventional treatment (n=40) is also scanned with PET/CT     right after the enrolment and after 16-week treatment with adalimumab. The first 15 patients     form a pilot group, which is used to check the validity of the power calculation.      The project will give essential new information on PET-detectable inflammation in the     patients with axial spondyloarthritis. The results will be published in international     publication series. The publications will form the basis for a doctoral thesis. Funding for     the project comes from Abbvie Ltd.   "
49742|NCT02634528|"     This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new     human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin,     Huminsulin® Basal. All participants will receive both study treatments on two separate dosing     days.   "
49743|NCT02634515|"     This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new     short-acting human soluble insulin, Julphar Insulin R, and the already approved reference     insulin, Huminsulin® Normal. The trial participants received both study treatments on two     separate dosing days.   "
49744|NCT02634502|"     This study aims to explore the efficacy and safety of radiofrequency ablation combined with     S-1 in pancreatic cancer patients with liver metastasis, as well as the correlation of serum     microRNA and patients' prognosis. This protocol will be overseen by the Fudan University     Institutional Review Board which has Federal Wide Assurance through the U.S. Department of     Health & Human Services (Approved: April 25, 2002).   "
49745|NCT02634489|"     A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after     co-administration of single entity tablets and of the combination tablet EC905 under steady     state conditions at three dose strengths.   "
49746|NCT02634476|"     It is well-established that many substance misusers experience impairment in cognition     (thinking skills), particularly those needed to regulate and monitor behaviour and ensure     that goals are achieved. According to the dual-process model, addiction arises from an     imbalance in 'bottom-up' processing i.e., overactive automatic (impulsive) processes that     drive behaviours and impaired 'top-down' controlling processes that stop behaviours     associated with negative consequences. As a result, the individual becomes more sensitive to     cues in their environment (e.g., alcohol images) that trigger the addictive behaviour.     Cognitive-bias modification (CBM) is a novel, computer-based training paradigm that trains     the brain to pay less attention to negative/harmful cues and more attention to positive or     neutral cues. This approach minimizes the overactive 'bottom-up' processes and improves the     'top-down' control processes of unhealthy behaviors which enables the addicted individual to     make better decisions. Recently, CBM has been used with addicted population to alter the     tendency to approach alcohol, with one German study showing that a 4-session training     programme was associated higher rates of abstinence at one-year (Wiers et al., 2011). The     current study examines whether a novel computer based training programme alters cognitive     biases (the tendency to approach alcohol related stimuli) in alcohol-dependent inpatients,     and examine whether this enables them to be better at decision-making more generally, and its     impact on craving and post-discharge abstinence rates. The study will also explore whether     individual differences in impulsivity and sensitivity to reward and punishment determine     response to the training programme. This will be achieved using a parallel-groups randomized     superiority trial design involving approximately 80 patients attending inpatient withdrawal     programmes in Victoria. The findings are likely to have implications for the design and     delivery of psychosocial interventions delivered during early recovery from     alcohol-dependence to optimise treatment effectiveness.   "
49747|NCT02634463|"     The purpose of this study is to collect whole blood and plasma venous and capillary samples     from participants taking aripiprazole, olanzapine, paliperidone, or risperidone for the     development of antipsychotic immunoassays.   "
49785|NCT02631928|"     This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new     human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin,     Huminsulin® Profil III. All participants will receive both study treatments on two separate     dosing days.   "
49748|NCT02634450|"     In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months     of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula,     Beira and Quelimane. However, test volumes are growing and many parts of the country do not     have close access to laboratories. Test samples are transported over large distances and this     can introduce testing delays, especially for patients in rural and remote areas of the     country. There are now new POC EID technologies becoming available that will enable diagnosis     of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non     technical staff and without laboratory infrastructure. This protocol describes a plan to     conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing     technologies that are being considered for use in Mozambique, and to pilot those technologies     in order to provide more effective diagnostics and clinical care to patients. During this     implementation pilot, sites are randomized to use either conventional or POC EID testing only     before the inclusion of the patients in the study. No consent will be asked to the parents or     guardians. A written permission will be asked to the Direção Provincial de Saúde of both     provinces to implement the POC device as routine in those intervention sites. All the     information that will be analyzed will be collected from the routine care and it will be     analyzed as a group.   "
49749|NCT02634437|"     This study is designed to observe the effect of renal function on the pharmacokinetic,     safety, and tolerability profiles of Ulipristal acetate following administration of a single     oral dose of a 10 mg Ulipristal acetate tablet.   "
49750|NCT02634424|"     The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven     prophylaxis in current clinical practice   "
49770|NCT02634164|"     Diabetes is classified as an impairment of the body's ability to control blood glucose     levels. Uncontrolled hyperglycemia can give rise to macrovascular (i.e., heart disease and     stroke) and microvasculature damage such as retinopathy, nephropathy and neuropathy. These     comorbidities may definitively reduce quality of life.      Hypotheses to be tested:        1. The ingestion of amino acids L-Isoleucine and L-Leucine at a therapeutic dose prior to a          glucose load will concurrently and independently improve glucose tolerance.        2. The ingestion of L-Isoleucine and L-Leucine separately or together will have a minimal          effect on incretin responses of Glucagon-like peptide-1 and Glucose-dependent          insulinotropic peptide (GLP-1, GIP).   "
49751|NCT02634411|"     Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units     (Réseau RAISIN 2012). A short duration (8 days; SD) vs. long duration (15 days; LD) of     antibiotic therapy has a comparable clinical efficacy with less antibiotic use and less     multidrug-resistant pathogens (MDR) emergence. These results have led the American Thoracic     Society to recommend SD therapy for VAP, with the exception of documented VAP of     non-fermenting Gram negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA-VAP), due     to the absence of studies focusing specifically on PA-VAP. Thus the beneficial effect of SD     therapy in PA-VAP is still a matter of debate. In a small (n=127) subgroup analysis, a higher     rate of recurrence with SD therapy (n=21, 32.8%) has been observed compared with LD therapy     group (n=12, 19.0%). Unfortunately, the definition of recurrence was essentially based on     microbiological rather than clinical data, and the higher rate of recurrence observed could     rather reflect a higher rate of colonization more than a new infection.      Interestingly, a trend for a lower rate of mortality was also observed in the SD group (n=15,     23.4%) compared with the LD group (n=19, 30.2%), but this study was clearly underpowered to     detect a difference of mortality between groups.      The two strategies were considered as not different, for the risk of mortality in a recent     meta-analysis, performed on the very few available studies (n=2), that (OR = 1.33, 95% CI     [0.33 to 5.26] for SD vs. LD strategies respectively). However, this conclusion remains     questionable considering the large confidence interval of the risk and the power of these     studies.      Primary objective and assessment criterion: To assess the non-inferiority of a short duration     of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in P. aeruginosa     ventilator-associated pneumonia (PA-VAP) on a composite end-point combining Day-90 mortality     and PA-VAP recurrence rate during hospitalization in the ICU.      Study Design :      Randomized, open-labeled non inferiority controlled trial 32 French Intensive Care Units     participating to the study      Research period:      Total study duration: 27 months Inclusion period: 24 months Duration of participation for a     patient: 90 days   "
49752|NCT02634398|"     The purpose of this Post Market Observational Study is to monitor the effect of the Axium®     SCS System in the management of chronic pain following surgical lumbar discectomy in subjects     whom are routinely scheduled for treatment with the Axium® SCS System.   "
49753|NCT02634385|"     Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral     tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic     skill. Renal vessel clamp for vascular control is a required step during standard LPN.     However, this creates a time limiting step for the surgeon and induces renal injury via warm     ischemia and reperfusion injury. This novel approach can substantially reduce renal injury     during LPN via superselective embolization of level II renal arteries pre-operatively. This     technique facilitates the performance of a clamp-less, zero-ischemia LPN, significantly     simplifying the procedure by remove time thresholds within which to perform tumor excision.     The preliminary results are promising; however, there is a need for further corroboration of     their results, in addition to a randomized controlled trial comparing this modified, zero     ischemia technique with standard LPN.   "
49754|NCT02634372|"     The purpose of this study is to determine whether EMDR (vs supportive therapy) is effective     in relapse prevention over an observational period of 2 years in bipolar patients with a     history of traumatic events.   "
49755|NCT02634359|"     The study objective is to collect data to assess the accuracy and reliability of Earlysense     fertility cycle monitoring performance vs. acceptable known reference methods such as blood     tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation     and pregnancy. In addition the collected data will be used to further enhance and improve the     existing algorithms.   "
49756|NCT02634346|"     This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation     of schizophrenia.   "
49782|NCT02631967|"     Kono and collegues have described a new anastomotic technique to restore bowel contintuity     after ileocecal resection for Crohn's disease (CD).      This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the     antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.      In a retrospective study, the authors have shown that this anastomotic tecnique, when     compared to stapled side-to-side anastomosis, significantly reduces the severity of     endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic     recurrence at 5 years after surgery.      Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved     by the stapled side-to-side anastomosis, within a prospective randomized study.   "
49757|NCT02634333|"     Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative     factor in human eye diseases characterized by neovascularization including proliferative     diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME).     While there is strong evidence that PDR outcomes are markedly reduced in eyes that are     treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With     Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes     Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing     during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I),     it is unknown whether or not an earlier but less frequent dosing regimen would result in     similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently     would result in favorable visual acuity outcomes.      If this study demonstrates that intravitreous aflibercept treatment is effective and safe for     reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for     these complications, a new strategy to prevent vision threatening complications of diabetes     will be available for patients. The application of intravitreous aflibercept earlier in the     course of disease (i.e., at the time when an eye has baseline severe non-proliferative     diabetic retinopathy) could help to reduce future potential treatment burden in patients, at     the same time resulting in similar or better long-term visual outcomes, if PDR and DME are     prevented.      The primary objectives of this protocol are to 1) determine the efficacy and safety of     intravitreous aflibercept injections versus sham injections (observation) for prevention of     PDR or CI-DME in eyes at high risk for development of these complications and 2) compare     long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of     disease with those that are observed initially, and treated only if high-risk PDR or CI-DME     with vision loss develops.      Secondary objectives include:        -  Comparing other visual acuity outcomes between treatment groups, such as proportion of          eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of at          least 5 letters at the consecutive study visit just before and at the 2- or 4-year visit        -  Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT          central subfield thickness and volume from baseline        -  Comparing proportion of eyes with at least 2 and 3-step worsening or improvement of          diabetic retinopathy severity level (scale for individual eyes) by central reading          center from baseline        -  Comparing associated treatment and follow-up exam costs between treatment groups        -  Comparing safety outcomes between treatment groups   "
49758|NCT02634320|"     This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as     ARISTADA, ALKS 9070).   "
49759|NCT02634307|"     This study will evaluate the long-term safety and tolerability of ALKS 8700 for the treatment     of Relapsing Remitting Multiple Sclerosis (RRMS)   "
49760|NCT02634294|"     Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with     hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation     (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years,     without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).      Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon     alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or higher     grade of acute GVHD, or no response to treatment after 8 doses of treatments.   "
49771|NCT02634151|"     The purpose of this study is to assess the efficacy, safety, and tolerability of multiple     doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not     adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients     with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100     mg/dL. Subjects will be randomized 1:1 to gemcabene 600 mg QD or placebo.   "
49772|NCT02634138|"     This study will assess the benefit of a neuromuscular electrical stimulation device in     patients suffering from symptoms and effects of critical limb ischaemia.   "
49773|NCT02633072|"     The objective of this study is to assess the visual outcome after the combined binocular     implantation of +2.75 D and +3.25 D full-diffractive multifocal intraocular lenses.   "
49761|NCT02634281|"     SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available     cessation programs are not effective for all smokers, new strategies are necessary for     tobacco control.      Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking     reduction and cessation compared with the standard varenicline treatment schedule.      Design: Parallel group, double-blind, randomised controlled clinical trial. Participants:     Smokers of both sexes from the general population. Methods: Participants will be randomized     into two groups of treatment. Subjects in Group A will receive varenicline for six weeks     while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During     this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent.     At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of     varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day     (QD)) and at week 1, 6, 12, and 24 after QD.      Measurements: These will include vital signs, smoking history, spirometry, expired CO,     salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is     continuous abstinence at 6 months.      Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A     vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).      Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test     (nominal variables) will be used as appropriate.      Expected benefits: This study might contribute to optimize the current use of varenicline.   "
49762|NCT02634268|"     Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI)     overlap. The investigators are trying to find out if a program proven to help people lose a     modest amount of weight and increase their physical activity will improve COPD symptoms for     those with a high BMI. The program uses a series of digital video discs (DVD) sessions     focused on healthy eating and physical activity, and encourages participants to monitor their     weight, diet, and physical activity for two years. For those who want to, they will be able     to work with a health coach to help meet weight and activity goals. We hope that the program     will lead to weight loss, better exercise tolerance, and less shortness of breath. To be in     the study, participants will need to have COPD, high BMI, history of smoking, shortness of     breath, and be at least 40 years old.   "
49763|NCT02634255|"     Rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to     provide conditions for endotracheal intubating. Recommended dose is 0,6 mg/kg and 90 seconds     after intravenous injection, patients can be intubated.      Anxiety levels may vary in patients undergoing emergency and elective surgery. Patients     undergoing emergency surgery may display exaggerated laryngoscopic responses. The purpose of     this study is to investigate the effect of patient anxiety levels on the onset time of     rocuronium in terms of anxiety scores and train of four (TOF) 0.1 times.   "
49764|NCT02634242|"     The purpose of the current study was to check the physiological improvement of SWT on liver     and skin and also the antioxidation in healthy adults.   "
49783|NCT02631954|"     Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection     200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in     Healthy Volunteers   "
49765|NCT02634229|"     Monogenic diabetes accounts for 1-2% of diabetes cases, although it is often misdiagnosed as     either type 1 diabetes or type 2 diabetes. Knowledge of the genetic etiology of diabetes     enables more appropriate treatment, better prediction of disease progression, screening of     family members and genetic counseling. These monogenic diabetes result from gene mutations     that reduce beta-cell function. To date, about 20 genes involved in insulin-secretion pathway     hav been identified; they correspond to a broad of two main clinical conditions [neonatal     diabetes mellitus (NDM) and Maturity-Onset Diabetes of the Young (MODY)]. However, it still     remains subtypes of monogenic diabetes that are unelucidated. The investigators project focus     on families with a clinical and familial history highly suggesting a MODY diabetes but     without genetic etiology. The investigators objective is to set up a collection of families     with at least three family members presenting a MODY diabetes.   "
49766|NCT02634216|"     The purpose of this 12 week longitudinal study is to test the effect of the dietary     supplement, Capros, on blood glycemic index of Type 1 diabetics that have a sensor that     provides continuous glucose monitoring (CGM). 20 Type 1 Diabetics will take the Capros     supplement for 12 weeks to determine the effect of blood glycemic index. Capros, is a     generally safe dietary supplement currently sold over the counter in the United States. Type     1 diabetes also known as juvenile diabetes is commonly diagnosed in children and young     adults. Insulin is converted into energy needed for daily living, and with diabetes, insulin     is not produced in the body as it should causing many problems. In traditional Indian     medicine, the gooseberry Phyllanthus emblica has been used for thousands of years as an     effective source of polyphenols and antioxidants. A 12 week longitudinal study to determine     the effect of the dietary supplement, Capros, on the blood glycemic index in patients with     Type 1 diabetes (T1D).   "
49767|NCT02634203|"     Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe form of pulmonary     hypertension characterized by obstruction of the pulmonary vasculature by residual organized     thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary     hypertension, and right failure.      In patients deemed operable, pulmonary endarterectomy (PEA) is the gold standard treatment     and is the only potentially curative treatment. However, some patients are ineligible for     surgery owing to occlusion of distal vessels. The best treatment option for these     non-operable CTEPH patients is not yet established.   "
49768|NCT02634190|"     To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA®     HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV     infection and high-grade CIN lesions in a screening population of women 30 years of age or     older in Germany.   "
49769|NCT02634177|"     In this randomized clinical trial, subjects will be assigned to either an assay-guided     treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide     a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay     results will be provided to the treating investigator, who will use the results to guide     antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the     subjects without the knowledge of the pharmacogenetic testing results. Assay results for all     subjects will be provided to the investigator once all Week 8 visit procedures have been     completed. Raters of the primary endpoint assessment and subjects will remain blinded to     treatment assignment.   "
49774|NCT02633059|"     This phase I/II trial studies the side effects and best dose of idasanutlin and ixazomib     citrate when given together with dexamethasone in treating patients with multiple myeloma     that has returned after a period of improvement. Drugs used in chemotherapy, such as     idasanutlin and dexamethasone, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Ixazomib citrate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Giving idasanutlin, ixazomib citrate, and dexamethasone     together may work better in treating patients with multiple myeloma.   "
49776|NCT02633033|"     This observational study aims to characterize the patient population and describe multiple     sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with     multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in     standard practice in the United States.   "
49777|NCT02633020|"     Protocol CELIM-RCD-002 is designed to be a Phase 2a randomized, double-blind,     placebo-controlled, parallel group study to evaluate the efficacy and safety of AMG 714 for     the treatment of adult patients with Type II Refractory Celiac Disease (RCD-II), an in situ     small bowel T cell lymphoma.   "
49778|NCT02633007|"     This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to     evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.   "
49779|NCT02632006|"     Objectives:      The purpose of this study is to evaluate the safety and efficacy of PIK-PD-1 Cells in the     treatment of advanced Hepatocellular Carcinoma.      Methods:      This study designs a novel therapy using PIK-PD-1 cells. 40 patients with advanced     Hepatocellular Carcinoma will be enrolled. They are randomly divided into dendritic     cell-precision multiple antigen T cells (DC-PMAT) group and PIK-PD-1 cells group. Both     DC-PMAT treatment and PIK-PD-1 cells treatment will be performed every 3 weeks with a total     of three periods. The mail clinical indicators are Progression-Free-Survival and Overall     Survival.   "
49780|NCT02631993|"     Cure of leukemia after hematopoietic stem cell transplantation (HSCT) is sustained by the     anti-leukemic effect of the grafted cells (graft-versus-leukemia (GVL)). However, it is not     known whether the tumor-immunity is affected by photochemotherapy (psoralene     photosensitization and ultraviolet light radiation) administered to attenuate graft-versus     host disease (GVHD).      The present study aim to investigate what happens to the GVL after photochemotherapy of aGVHD     in a predominantly retrospective setting with 10-years follow-up after HSCT   "
49781|NCT02631980|"     Hepcifer Trial is designed to assess the value of iv iron administration immediately after     liver surgery and consequences of inflammation on iron balance. Fifty patients will be     randomized in two treatment groups. Patients will be assigned to receive either iv iron or     placebo immediately after liver resection surgery. Biological inflammation parameters,     hemoglobin, serum iron and hepcidin levels will be assessed prior to surgery and at day 1, 3,     7, 15 and 30 after surgery.   "
49786|NCT02631902|"     Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population     and is associated with a high cardiovascular mortality by coronary artery disease and     cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are     widely recommended to the control of type 2 diabetes and its complications. This study aims     to analyse the effects of different community-based lifestyle programs (exercise or exercise     plus dietary intervention) on health and well-being in patients with type 2 diabetes.   "
49799|NCT02633982|"     In atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke     preventive. Meantime,Warfarin may also increase the risk of hemorrhagic events. Considering     this,warfarin is a drug which puts a great burden on patients and medical providers.      With the population aging, the number of non-valvular atrial fibrillation patients is     increasing, and a necessity that not only specialist but also general practitioners.     Anticoagulant therapy with warfarin is not easy for general practitioners and is not commonly     used among general practioners. In such circumstances, Rivaroxaban,a new oral direct factor     Xa inhibitor,has become available. Rivaroxaban is administrated once a day and exert an anti-     coagulant effect soon after administration. It hardly reacts with foods or other drugs and     therefore does not require regular monitoring. GENERAL study is to investigate the     effectiveness of stroke and systemic embolism in non-valvular atrial fibrillation patients     when it is prescribed by general practioners in real life settings.   "
49787|NCT02631889|"     Major lung resection is one of the most common procedures performed in thoracic surgery, but     it may involve considerable bleeding and the occasional need for a transfusion and/or     reoperation for bleeding in specific cases. In addition, lysis of pleural-parenchymal     adhesions and dissection can represent a challenge in patients who have undergone     chemotherapy and/or radiation therapy, and in patients with bronchiectasis or COPD. Several     intraoperative methods have been used to manage blood loss, including topical haemostatic     agents, bipolar sealers or electrocautery. Transcollation technology (TT) consists of a     disposable bipolar sealer that uses a radiofrequency coagulation system to deliver a saline     solution that provides haemostatic sealing of soft tissue and bone and provides localized     cooling without charring. Blood loss reduction has been previously described in several     fields of surgery.      The primary end-point of the proposed trial is to assess if the ability of Transcollation     Technology in reducing the proportion of patients showing bleeding perioperatively within the     setting of a prospective randomized controlled trial.      The secondary end-point is to assess if Transcollation Technology is able to improve     postoperative outcomes reducing the length of hospital stay.   "
49788|NCT02631876|"     This is a Phase 3, open label, randomized study designed to compare the safety and efficacy     of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women     with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or     fallopian tube cancer.   "
49789|NCT02634112|"     Primary Endpoint:      The main objective of this National Registry is to identify the incidence and to analyse the     risk factors for anastomotic leakage in rectal cancer surgery From the operational point of     view, the aim of this Registry is to systematize the collection of information on the     different surgical services. This Registry claims to have National audit functions, allowing     thus the knowledge of the procedures performed at each center that could enable the     establishment of the best standard of care.      Secondary Endpoints:      To determine the real incidence of anastomotic leakage according to the different locations     and techniques: uniform definition of anastomotic leakage.      To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR.      To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR.      To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL     FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and     mortality.      To create and validate an anastomotic leakage predictive Score.   "
49790|NCT02634099|"     Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels   "
49791|NCT02634086|"     The study is to determine the long-term outcome of patients with coronary triple vessels     disease (TVD) in the real world of China, by three different treatment strategies:     percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal     medication therapy (OMT).   "
49792|NCT02634073|"     Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral     agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults     and children. Documented literature elucidates that simultaneous administration of multiple     sorbitol-containing products could increase the potential for a significant interaction and     may contribute to the lower 3TC exposures.      In this study several sorbitol doses (3.2 gram (g), 10.2 g, and 13.4 g solutions) will be     administered with lamivudine to investigate dose dependency and mimic the situation where     multiple sorbitol-containing antiretroviral medications may be co-administered with     lamivudine. It will be open label, randomized, 4-way crossover (by William's design method)     design at a single centre. Randomized participants will receive a single dose of each of four     treatments after wash out period of minimum 7 days.   "
49793|NCT02634060|"     Recently a smartphone application IBDoc® was developed to enable patients to measure faecal     calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of     these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term     outcome to ADA induction therapy in patients with moderate-to-severe IBD.      Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be     asked to participate in this study. They will be asked to collect a stool sample at 3     different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test     cassette with an extraction device. In a second step, the patient can turn his smartphone     into an easy to use test cassette reader by taking a picture and using the CalApp® which is     based on an immunochromatographic test. Finally, the CalApp® will transmit the test results     securely to the health care professional.      In this study we want to evaluate the predictive value of absolute and relative faecal     calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week     12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA     measurements of faecal calprotectin, and the convenience of this system to the patient and     the health care professional.   "
49794|NCT02634047|"     The primary aim of this study is to investigate the difference in the first attempt and     overall success rate of different techniques for insertion of transesophageal     echocardiography. Secondary aim is to investigate the difference of the duration of insertion     using the selected technique, complications during insertion such as oropharyngeal mucosal     injury and hematoma.   "
49795|NCT02634034|"     The purpose of this study is to compare the pharmacokinetics and safety of a controlled     release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR)     pitavastatin in healthy adult volunteers.   "
49796|NCT02634021|"     Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and     hypertension.   "
49797|NCT02634008|"     An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir,     dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently     acquired hepatitis C virus infection with or without HIV co-infection.   "
49798|NCT02633995|"     The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as     these patients present particular hazards with general anaesthesia, such as concerns for     rapid airway control and cerebral blood flow alterations during induction of general     anaesthesia and intubation However, the incidence of hypotension is high during spinal     anesthesia for Cesarean section and it may approach values up to 95 %.   "
49802|NCT02633943|"     This is a multi-center, long-term safety and efficacy follow-up study for subjects with     hemoglobinopathies (β-thalassemia or severe sickle cell disease) who have been treated with     ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After     completing the parent clinical study (approximately 2 years), eligible subjects will be     followed for an additional 13 years for a total of 15 years post-drug product infusion. No     investigational drug product will be administered in the study.   "
49803|NCT02633930|"     This study aims at evaluating efficacy and safety of berberine-containing quadruple     therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing     quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori     eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior     to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive     status will be randomized to one of the treatments described above. At week 2 and 6 follow-up     visits, a urea breath test(UBT) will be performed to confirm eradication.   "
49804|NCT02633917|"     The purpose of the present study was to evaluate and compare the effects of motor control     exercises and standard exercises in the pain, incapacity and medicine intake of subjects with     unspecific low-back pain.   "
49805|NCT02633904|"     Although older children and high dislocations may be more likely to require a femoral     shortening osteotomy, the ultimate decision about whether or not to shorten a given femur     should depend on the ease of femoral head reduction in that specific patient. Adding a     femoral shortening procedure increases operating time and blood loss, adds a second incision,     and necessitates future hardware removal. In addition, an unnecessary femoral shortening     osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at     risk for redislocation. This study was designed to explore an algorithm based on strict age     and radiographic criteria that identify those without the need of femoral osteotomy.   "
49806|NCT02633891|"     Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the     MetS are at risk for not only future chronic diseases, but they have a higher prevalence of     neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls.     Currently there are no effective therapies to prevent or reverse the neuropathy seen in the     MetS or to reduced the fall risk in this population. This research project will determine if     a tailored balance exercise program will have functional benefits and result in a reduced     fall risk in the growing population of patients with the MetS and neuropathy.   "
49807|NCT02633878|"     Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain,     while the cervix is closed and the fetus is viable and inside the uterine cavity.Threatened     miscarriage is a common complication of pregnancy occurring in 20% of all clinically     recognized pregnancies and about half of these will eventually result in pregnancy     loss.Micronized progesterone which is used in a range of indications including infertility     due to luteal insufﬁciency and threatened and habitual abortion, has a similar molecular     structure and pharmacological effects to endogenous progesterone.Chinese Herbal Medicines is     a part of Traditional Chinese Medicines and has been widely used for the treatment of     miscarriage in China and other Asian countries for centuries.CHM have become very popular     alternative to Western medicines and are commonly used as an alternative treatment for     threatened miscarriage.Amongst all the causes for threatened miscarriage, Kidney Deficiency     is the most important cause leading to threatened miscarriage and Shou Tai Pill is the most     frequently used formula (72.0%) to treat threatened miscarriage.This basic formula is made up     of four individual Chinese medicines, including Chinese Dodder Seed (Semen Cuscuta), Chinese     Taxillus Twig (Flerlia Taxillus), Himalayan Teasel Root (Radix Dipsaci), and Donkey-hide Glue     (Colla Corii Asini).Furthermore, supplementary of Common/Wingde Yan Rhizoma in the formula     can enhance the therapeutic effects by further strengthening kidney of pregnant women.The     goal of this double-bind, randomized and double dummy controlled trial is to determine which     of the two oral medications, CHM or Micronized progesterone, and will mostly likely result in     live birth in women with threatened miscarriage.   "
49847|NCT02633358|"     Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong     inflammatory response, result in multiple organ failure, even death.      While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6     bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate     and well cerebral performance.   "
49894|NCT02632656|"     The primary objective is to measure the association between extracellular RNA (ex-RNA) levels     in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac     remodeling and (2) cardiovascular events. The investigators will follow patients during     standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how     these are associated with cardiac remodeling (by cardiac imaging) and outcomes.   "
49808|NCT02633865|"     Age-related cataracts remain the leading cause of treatable blindness in China. The     prevalence of cataract blindness continues to climb due to the expanding elderly     subpopulation. Surgery is the only available treatment; however, the cataract surgical rate     (CSR) in China remains relatively low relative to affluent countries or certain developing     areas. Studies have reported that the primary barrier to cataract surgery is financial     difficulty, and this challenge could be efficiently addressed by reducing the surgical fee or     providing free cataract surgery. However, the prices, availability and affordability of     medicines or medical services to the poor in China require further improvement. Although a     host of free cataract screening and surgery programs have been widely implemented in rural     areas of China, free cataract surgery programs have rarely been implemented in     financially-challenged urban China. Even in Guangzhou, one of the largest metropolises in     China, many low-income cataract patients, a neglected cohort, continue to need cataract     surgery. A program titled care for your eyes, lighten your life, jointly sponsored by the     People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou     Municipality, and the Zhongshan Ophthalmic Center (ZOC), has been initiated in Guangzhou to     implement a program of free clinics in parks and free cataract surgery targeting the     impoverished population living in urban China in 2012. After 3 years' exploration, the     management mode of this program has been perfected, and approximately 4000 cataract surgeries     had been performed on the low-income elderly.      Although there are a large number of poor communities throughout the country, free cataract     surgery programs in poor urban China are restricted to several metropolises due to limited     medical resources and social overlook. Fully understanding patient satisfaction regarding the     free cataract surgery program and understanding the patient characteristics of this special,     neglected community may contribute to the improvement and the further expansion of the     management mode of free cataract surgery programs.   "
49809|NCT02633852|"     A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of     Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema - TADI     Study   "
49810|NCT02633839|"     This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety     of a single dose of CVT-301 in smoking and non-smoking adults.   "
49811|NCT02633826|"     This investigator-initiated study will analyse the role of pre-formed alloreactive T cells on     acute rejection episodes and graft outcome in kidney transplant recipients after living     donation.   "
49812|NCT02633813|"     The current study was randomized, double blind, placebo-controlled, prospective, multicenter,     comparative therapeutic equivalence study.      The study duration for each patient was 6 weeks: Following were the visit details.      V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 +     2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at     the end of week 6 + 4 days).   "
49813|NCT02633800|"     This study will test an investigational study drug called patritumab. It is a 'randomized     study' which means participants have an equal chance of being assigned to receive the     experimental medication (patritumab) or a substance that looks like the experimental product,     but is not (placebo). Patritumab may work when combined with other medications that are     approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or     carboplatin. All participants will receive the other medications approved for treatment of     head and neck cancer, even if they do not receive the experimental product.   "
49814|NCT02633787|"     The aim of this study is to provide information on the persistence of bactericidal antibodies     following Menactra booster vaccination in study MTA77 ( NCT01442675).      Objective:        -  To evaluate the persistence of antibody responses (determined by a serum bactericidal          assay using human complement (SBA-HC)) approximately 4 years after the administration of          a booster dose of Menactra vaccine in trial MTA77   "
49815|NCT02633774|"     Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or     dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion.     The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with     hemodynamic amelioration compared to AF state. We will randomize the patients with persistent     AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive     function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings     will be compared between rhythm control group and rate control group of persistent AF.   "
49816|NCT02633761|"     The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus     misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.   "
49817|NCT02633748|"     Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but     has not been extensively studied in cancer survivors. This study will enroll cancer survivors     at the Greenville Health System Cancer Institute Center for Integrative Oncology and     Survivorship to undergo the Mindfulness Based Cancer Survivorship (MBCS) four-week program,     with assessments before, immediately after, and three months after the intervention. Results     of the study will be used to develop new care models that improve cancer survivor stress and     symptoms using mindfulness.   "
49818|NCT02633735|"     Although appendicitis is the most common surgical emergency in children, its diagnosis     remains a challenge and thus, emergency department (ED) providers increasingly rely on     computed tomography to distinguish appendicitis from other conditions. This project (a) uses     electronic health record (EHR) technology to deliver patient-specific clinical decision     support to ED providers at the point of care, (b) assesses the impact of this intervention on     the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the     intervention on the costs of care delivered. This innovative project will be a template for     extending EHR-based clinical decision support to other domains of emergency care to     ultimately improve a broad range of pediatric acute care outcomes.      The proposed intervention, referred to as appy-CDS, is specifically designed for widespread     use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and     adolescent patients with acute abdominal pain while maintaining or improving clinical     outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical     decision support tool to optimize care for children and adolescents presenting to a general     or non-pediatric ED with acute abdominal pain.   "
49890|NCT02632708|"     The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120     and AG-221 when given in combination with standard AML induction and consolidation therapy.     The study plans to evaluate 1 dose level of AG-120 in subjects with an IDH1 mutation and 1     dose level of AG-221 in subjects with an IDH2 mutation. AG-120 or AG-221 will be administered     with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin)     and 2 types of AML consolidation therapies (mitoxantrone with etoposide [ME] or cytarabine).     After consolidation therapy, subjects may continue on to maintenance therapy and receive     daily treatment of AG-120 or AG-221 for up to 2 years from Day 1 of the first induction     cycle, or until relapse, development of an unacceptable toxicity, or hematopoietic stem cell     transplant (HSCT).   "
49819|NCT02633722|"     Obesity is a serious medical condition, the adverse consequences of which include increased     risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic     cost of obesity was placed at $58 billion dollars in Australia in 2008. Studies in mice and     non-human primates have shown that moderate caloric restriction (CR) increases lifespan and     reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes. Reduced risk of     chronic diseases is also observed in humans following CR. However, daily CR is difficult to     maintain long term, since the body defends against weight loss by inducing metabolic     adaptation and altering the hormonal appetite response. An emerging number of studies are     examining the effects of limiting food intake to prescribed time periods per day, or every     other day. Intermittent, or time restricted feeding describes a dieting approach where food     is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This     study will examine the effects of fasting for 15h/day and eating for 9-h per day on glycemic     control and metabolic health. This study will build on the existing knowledge base in humans     as to whether meal timing, rather than caloric restriction per se, is important to provide     the stimulus required to improve metabolic health and reduce risk of chronic disease.     Moreover, it will examine whether restricting feeding to later in the day is of lesser     benefit to health.   "
49820|NCT02633709|"     The objective of this study is to assess the safety and tolerability of RO7034067 (RG7916) in     healthy people. The study will assess what the body does to RO7034067 (RG7916) and what     RO7034067 (RG7916) does to the body. RO7034067 (RG7916) will be given by mouth in gradually     increasing doses. The data from this study will help to define the dose to further explore     RO7034067 (RG7916) in patients with Spinal Muscular Atrophy.   "
49821|NCT02633696|"     This clinical trial phase I in healthy volunteers is intended to describe the oral     bioavailability of the silybin-phosphatidylcholine complex by calculating the area under the     curve (AUC0-? and AUC0-12) after administration of the same dose of oral silybin (AUCo) and     intravenous silybin (AUC iv).   "
49822|NCT02633683|"     The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT     (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years     of age) diagnosed with moderate-to-severe primary RLS.   "
49823|NCT02633670|"     Kidney transplantation remains one of the most common organ transplanted today but the     surgical technique has changed very little from the original pelvic operation. The deceased     donor renal transplant poses a particular challenge to the surgeon due to lack of detailed     pre operative vascular assessment. The hemopatch is a promising new sealing synthetic     hemostatIc agent with a novel dual mechanism of action that is more convenient to apply     rather then using other hemostatic agents, which require warming and/or mixing.   "
49824|NCT02633657|"     The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the     single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years     of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).   "
49826|NCT02633631|"     The Contraceptive Choice Center will use an innovative-model of contraceptive care which was     developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will     deliver high-quality family planning services for women and reduce unintended pregnancies and     births. This intervention will result in improved health for women, improved health care, and     reduced costs to Medicaid.      The Center will provide care to women ages 14-45 years of age.   "
49827|NCT02633618|"     A randomized, open-label , positive drug controlled (Neurotropin,Japan organs Pharmaceutical     Co., Ltd. ), multi-center study to evaluate Analgecine's efficacy and safety for the     treatment of neuropathic pain.   "
49828|NCT02633605|"     First Sense Medical®, LLC is a medical device company developing a novel breast cancer     screening tester called the First Sense Breast Exam® Tester. This radiation free tester is     being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory.     When the tester is in production, a test will take approximately 7 minutes and will be     performed in a doctor's office.   "
49829|NCT02633592|"     To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more     naturalistic / physiological upright, seated position on a commode provides a more valid     assessment of anorectal function and simulated defecation than the same test performed in the     standard, left lateral position   "
49830|NCT02633579|"     In this study, the investigators will evaluate if the food intake associated with the     infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown     effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic     receptor antagonist, to inhibit the formation of contractions induced by a low dose of     erythromycin   "
49831|NCT02633566|"     The purpose of this study is to investigate the efficay of functional plantar orthoses on     flatfoot in children.   "
49832|NCT02633553|"     This study is designed to investigate whether adjuvant radiotherapy after complete resection     has a better survival for stage II or III thymoma.   "
49833|NCT02633540|"     The aim of this study is to define a new treatment technique for T1a larynx cancer that     maintains excellent local control with less extensive radiation fields. It is thought that     this will lead to patients having fewer changes to their voice and a higher quality of life     after treatment when compared to the current standard treatment.   "
49834|NCT02633527|"     This is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group,     fixed dose study to assess the efficacy and safety of SPN-812 ER in treatment of children     aged 6-12 years with ADHD. The primary objective is to assess the effect of SPN-812 ER in     reducing ADHD symptoms. This will be measured using the ADHD-RS-IV rating scale.   "
49835|NCT02633514|"     This study is designed to investigate whether adjuvant radiochemotherapy after incomplete     resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.   "
49895|NCT02632643|"     The study aims to demonstrate the efficacy of the sensorimotor approach developed by A. Piron     (taught to the patient in three sessions) regarding three parameters related to TMD: facial     pain, functional incapacities and hypertonia.      The subjects in the study are 18 to 77 years old and present the following conditions: a TMD     disorder caused or aggravated by hypertonia and responsible for cervico-maxillo-facial pain     and/or a functional incapacity in the last 30 days.   "
49836|NCT02633501|"     The purpose of this study is to determine an effective and safe clinical dose of a new     gadolinium-based contrast agent (GBCA) P03277 injection for Central Nervous System (CNS)     lesion detection and visualization by conventional steady-state CNS imaging. Therefore,     Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to     contrast medium/GBCA efficacy, has been chosen as the primary endpoint in order to have a     precise determination of P03277 clinical dose.      This is a multi-center, international, prospective, double-blind, randomized, controlled,     parallel dose groups, cross-over with comparator study in male and female subjects presenting     with either known or highly suspected focal areas of disruption of the Blood Brain Barrier     (BBB) (e.g. primary and secondary tumors, focal inflammatory or demyelination disorders), who     are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the     CNS.      This study will be conducted in approximately 40 centers worldwide.      Two subsets of subjects will be included in the study:        -  The first subset will include the first subject of each study center. Subjects will be          administered at 0.05 or 0.1 mmol/kg body weight (BW) of P03277 and MultiHance®, 0.1          mmol/kg BW.        -  The second subset will comprise all other subjects selected by the sites. Subjects will          be administered at 0.025, 0.05, 0.1, 0.2 mmol/kg BW of P03277 and 0.1 mmol/kg BW of          MultiHance®.      During the course of the study, two MRIs will be obtained from each subject: one unenhanced     and P03277-enhanced MRI; and one unenhanced and MultiHance®-enhanced MRI. MRI evaluations     will be performed by on-site investigators and three independent off-site blinded readers.   "
49837|NCT02633488|"     The purpose of this study is to look at how insulin (a hormone that helps the cells get     energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels     and blood flow in the smaller blood vessels in the arm) and how Metformin (a drug that makes     you more sensitive to insulin) affects insulin's action on the blood vessels.   "
49838|NCT02633475|"     This study aimed to assess the correlation between the interleukin-10 (IL-10)-1082A/G     polymorphism and idiopathic recurrent miscarriage (IRM) of Chinese Han. A total of 100 women     with IRM and 100 control women with a successful pregnancy will be included in this study.     Then genotyping will be performed.   "
49839|NCT02633462|"     The Purpose of this study is to assess the correlation between the inflammatory periodontal     status and the medical treatment status in Polycystic Ovary Syndrome(PCOS) women with     systemic inflammation and to evaluate the effect of non-surgical periodontal therapy in the     form of scaling and root planing along with medical treatment on the level of serological     marker of inflammation (High sensitivity-C Reactive Protein) and insulin resistance in PCOS     women with chronic periodontitis.   "
49840|NCT02633449|"     The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with     prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to     symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.   "
49841|NCT02633436|"     To explore the significance of Solute Carrier Family 1 Member 5 (SLC1A5) in the occurrence of     esophageal cancer, by comparing the expression of SLC1A5 between esophageal cancer tissues     and adjacent tissues.   "
49842|NCT02633423|"     During general anesthesia a reduction of Functional Residual Capacity (FRC) was observed. The     reduction of FRC could imply that respiratory system closing capacity (CC) exceeds the FRC     and leads to a phenomenon called expiratory flow limitation (EFL). Positive End-Expiratory     Pressure (PEEP) test is a validated method to evaluate the presence of EFL during anesthesia.     Aim of the study will be to asses if mechanical ventilation during CardioPulmonary Bypass     (CPB) in cardiac surgery could reduce the incidence of EFL in the post-CPB period. Primary     end-point will be the incidence of EFL, assessed by a PEEP test, performed at different     time-points in operating room. Co-primary end-point will be shunt fraction, determined before     and after surgery.      This will be a single center single-blind parallel group randomized controlled trial.     Patients will be randomly assigned to three parallel arms with an allocation ratio 1:1:1, to     receive one of three mechanical ventilation strategies during CPB.        1. Ventilation stop during CPB;        2. Continuous Positive Airway Pressure (CPAP) during CPB, with an airway pressure of 5          cmH2O;        3. Low tidal low frequency ventilation, with 5 acts per minute, with a tidal volume of 2-3          ml/kg of IBW and a PEEP of 5 cmH2O.   "
49843|NCT02633410|"     The anteromedial (AM) portal technique was introduced to position the femoral tunnel in     anterior cruciate ligament (ACL) reconstruction to more closely replicate the original     footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated     differences in these techniques with respect to clinical outcomes. The purpose of this study     was to determine if there are any differences in clinical outcome between the AM and TT     approaches.   "
49844|NCT02633397|"     The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled,     parallel groups study aimed to evaluate the safety, tolerability and the efficacy of     riociguat compared with placebo in patients with SCD.   "
49845|NCT02633384|"     Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and     exclusive parenteral nutrition (PN). Infants subjected to major surgery are often unable to     receive enteral nutrition for a long period of time, during which they require exclusive PN.     In preterm infants, hepatic immaturity is a predisposing factor. Intravenous lipid emulsions     (ILE) used in PN may promote PNAC or protect against it depending on their composition.     Medium chain triglycerides (MCT) may have a hepatic protective effect. Long chain     triglycerides (LCT) of n-3 family may protect from PNAC. In several new-generation emulsions,     the α-tocopherol content is higher than the gamma-tocopherol content, acting as an     antioxidant, preventing lipid peroxidation.      The incidence and severity of PNAC in term and near-term infants subjected to corrective     surgery for congenital abnormalities and needing prolonged PN using the ILE SMOFlipid® or     Lipofundin® is compared. The investigators hypothesise that SMOFlipid® is more protective     from PNAC than Lipofundin®.      Single-center, randomized, controlled and double-blinded trial on consecutive neonates     admitted in the NICU, with gestational age of 34 weeks or over, undergoing corrective surgery     of congenital anomaly of the digestive tract or indirectly affecting the digestive tract.     Recruitment if PN with ILE was started within the first 48 hours after birth. Minimum     intervention: exclusive PN for at least 1 week.      Main outcome: incidence of cholestasis (conjugated serum bilirubin >1 mg/dl [34 mmol/L]).     Severity of cholestasis evaluated by the magnitude of the serum conjugated bilirubin and     serum γ-glutamyltranspeptidase (GGT). Mixed effects regression models are used to take into     account the correlation structure between measures in time. Crude and adjusted odds-ratios     with corresponding 95% confidence intervals are calculated.   "
49846|NCT02633371|"     This is a single-center, prospective, open-label, outpatient pilot study evaluating the     efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.   "
49848|NCT02633345|"     The aim of the study is to investigate the effect of tablets containing probiotic candidate     strains, on gingival inflammation and the levels of selected pro- and anti-inflammatory     cytokines in gingival crevicular fluid (GCF). A secondary aim is to describe the effect of     the tablets on the salivary microbiome. The null hypothesis is that the clinical     measurements, levels of cytokines and microbial composition of saliva will not differ from     baseline or between the study and control group.      The study is planned as a double-blind; placebo controlled randomized trial with two parallel     arms. The intervention period is planned to be 4 weeks.      80 participants are planned to be enrolled after informed consent and then randomly allocated     to either the probiotic group or the placebo group.      The participants are randomly assigned to one of the study groups and given supply of either     probiotic tablets or placebo tablets.      The probiotic tablets contain Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2 at     a dose of 1 * 109 CFU(Colony Forming Units)/tablet. The participants will take two tablets a     day for four weeks. Follow up registrations are conducted after two weeks, four weeks and six     weeks.      At each visit, saliva and GCF will be collected and then plaque index (PI)) and bleeding on     probing (BOP) will be registered.      All data will be processed with SPSS software (v 22.0; Chicago, Ill, USA). The follow-up     values are compared to baseline within each group by Wilcoxon paired two-sided test and     differences between groups are analyzed by Wilcoxon unpaired test. A p-value < 0.05 is     considered statistical significant.      The participants are fully covered by the patient insurance of The School of Dentistry which     cover any damage to the trial participant during the study .There is no expected side effects     to the treatment with probiotics. Probiotics are generally considered safe (GRAS: Generally     Recognized As Safe) by The European Food Safety Authority (EFSA).      The participants will not benefit directly from the treatment, but the knowledge gained from     the study might contribute to the prevention of microbial derived illnesses in the mouth,     e.g. caries and periodontitis, in the future. The sample collection does not cause any     discomfort to the participants and the tablets have no known side effects. Therefore, the     personal benefit of the participants corresponds to the minimal risk and discomfort to the     participants.   "
49849|NCT02633319|"     The Malezi ne Kilimo Bora (Good Parenting and Farming in Kiswahili) Skilful Parenting and     Agribusiness Child Abuse Prevention Study is a collaboration between the University of     Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR).     It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention     implemented by Investing in Children and Our Societies (ICS), an international     non-governmental organization (NGO) with extensive experience operating in rural Tanzania.     The overall focus of the project is to evaluate ICS's agribusiness and skilful parenting     programmes' impact on the prevention of child maltreatment and improvement of child and     family psychosocial and economic wellbeing (n = 8 villages, n = 16 farmer groups, n = 240     families).   "
49850|NCT02633306|"     Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant     suffering and disability. This study will explore the ability of fMRI to identify patients     with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.      Specific Aims:        1. To establish baseline patterns of MRI in patients with chronic oro-facial pain without a          definitive etiologic diagnosis.        2. To estimate the rate of treatment success of transcranial stimulation of the primary          motor cortex (M1) in these patients.        3. To identify post-treatment MRI patterns that are associated with treatment success.   "
49851|NCT02633293|"     This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled     treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with     interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE).     The study will include about 266 patients who completed all required assessments in the     RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your     participation in this study is voluntary and will last until you discontinue from the study     or the study ends. The study will continue until each subject reaches the Week 108 visit or     until inhaled treprostinil become commercially available for patients with PH associated with     ILD including CPFE (whichever is sooner).   "
49852|NCT02633280|"     COPD is an inflammatory disease characterized by enhanced chronic airway and lung     inflammatory responses to noxious agents (e.g. smoke, pollutants) and progressive airflow     limitation. In COPD patients there is a spillover of peripheral lung inflammation into     systemic circulation resulting in increased level of various inflammatory markers such as:     IL-1β, IL-6, IL-8, and TNF-α.      Diagnosis, now, is based on clinical evaluation and spirometry test and COPD treatment     includes the use of LABA, LAMA and corticosteroids.      To data no plasmatic marker able to identify the stage of COPD and the response to the     treatment have been documented . The aim of this study is to evaluate in COPD patients the     role of microRNA as predictive biomarker, of the disease in order to have a signature of miRs     typically of COPD   "
49853|NCT02633267|"     Social anxiety disorder is a highly prevalent condition that interferes with employment.     Prior research indicates that social anxiety disorder interferes with work attainment. This     project involves a two-site randomized trial of a community-based cognitive-behavioral     intervention to reduce social anxiety and improve employment outcomes among unemployed     persons with social anxiety disorder.   "
49854|NCT02633254|"     So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided     High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are     known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes     a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power     sonications (heating points) will be used to occlude (part of) the feeding vessels of the     fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to     transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently, the     bulk volume of the fibroid can be treated using the standard approach.   "
49855|NCT02633241|"     This is a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine     can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI.   "
49856|NCT02633228|"     The objective of this study is to assess the visual outcome after the combined binocular     implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.   "
49857|NCT02633215|"     This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled     with functional motor training, to improve hand motor function in poorly recovered stroke     patients. The central hypothesis is that stroke patients with severe motor deficit receiving     hand nerve stimulation and intensive task-oriented therapy will have improved motor function     compared to patients receiving sham nerve stimulation and task-oriented therapy.   "
49913|NCT02632396|"     This phase I/II trial studies the side effects and best dose of ixazomib citrate (ixazomib)     and to see how well it works after stem cell transplant in treating patients with mantle cell     lymphoma that are no longer showing signs or symptoms of cancer. Ixazomib may stop the growth     of cancer cell by blocking enzymes needed for cell growth. Giving ixazomib after transplant     may help prevent the cancer from coming back.   "
49914|NCT02632383|"     A multicenter randomized controlled trial testing the app Young with Diabetes   "
49858|NCT02633202|"     Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard     treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National     Comprehensive Cancer Network guideline. However these recommendations were based on the     evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of     intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better     treatment outcomes than 2DCRT. It has been questioned whether additional concurrent     chemotherapy is still necessary for intermediate risk NPC within the excellent framework of     IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to     determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC     patients treated with IMRT. Given the results of clinical studies mentioned above,the     investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22,     43   "
49859|NCT02633189|"     The purpose of this study is to test whether the combination of bevacizumab and erlotinib can     prolong progression free survival as compared with erlotinib alone as first-line treatment in     patients with non small cell lung cancer (NSCLC) with activating mutation of EGFR.   "
49860|NCT02633176|"     This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus     docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by     concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal     carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy and     chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive and     prognostic factors for mNPC.   "
49861|NCT02633163|"     The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells     (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus     erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC     infusion plus standard of care respond better than patients receiving placebo infusion plus     standard of care.   "
49862|NCT02633150|"     Obesity, chronic disease, is a real public health problem because of its high prevalence but     also because of the high risk of complications, including insulin resistance (IR) and type 2     diabetes (T2D). The mechanisms involved in the development of IR are not well known.     Oxidative stress and inflammation induced by food overload could be the initiators IR     mechanisms in skeletal muscle, responsible for the use of nearly 80% glucose in response to     insulin and therefore plays a major role in the regulation of glucose metabolism. Thus, an     increase in ROS (Reactive Oxygen Species), markers of oxidative stress and chronic low-grade     inflammation have been demonstrated in subjects with obesity, the latter decreasing in weight     loss. Therapeutically, loosing weight is still very difficult these days, because of the     complexity of this chronic disease. Thus, it is well established that restrictive diets to     expose weight rebound, dramatic medically as in human terms for these patients. Support for     physical activity is also difficult because of reduced mobility in patients, refer to the     lack of motivation among some. Finally, investigators have no treatment against-obesity who     have demonstrated a benefit / risk enough to be used routinely. It is therefore essential to     seek other means of struggle against the IR, see help in weight loss.      In parallel, it is well established that the consumption of certain antioxidants, including     polyphenols (PP) grape as extracts and whole foods, modulates favorably several pathways     responsible for the development of IR in cell models animals. The results of antioxidants     supplementation in humans are few and controversial. However, most supplementation studies in     human used a PP, Resveratrol at supra nutritional doses (ie not compatible with a balanced     diet of fruits and vegetables). In a previous study, investigators tested the interest of a     supplementation with red grape PP nutritional doses in healthy subjects with metabolic risk     (overweight subjects and related to the first degree of T2DM patients) on IR hyperinsulinemic     euglycemic clamp measured. During this study, the PP have prevented the central mechanisms of     muscle IR that are oxidative stress and mitochondrial dysfunction induced by a load fructose.      For this project, investigators propose to test the effect of a red grape PP supplementation     at nutritional doses for 8 weeks on IR and weight loss in 30 obese insulin resistant. This is     a double-blind randomized placebo-controlled. This supplementation will be associated with a     standard support for their obesity performed routinely in the Nutrition and Diabetes unit.      Specific inclusion criteria: Female or male nondiabetic 50-65 years, BMI> 30 kg / m2 and with     a HOMA> 3.      The main objective is to test whether supplementation PP improves systemic insulin     sensitivity (GIR: rate glucose infusion) measured by hyperinsulinemic-euglycemic clamp (gold     standard for measuring insulin sensitivity) in insulin-resistant obese subjects.      Secondary objectives are to:        -  Test whether supplementation PP improves insulin sensitivity to tissue (fat and muscle)          and compare the response to supplementation in these two tissues.        -  Determining the cellular and molecular mechanisms involved in improving IR: regulation          of inflammation, oxidative stress.        -  Determine whether supplementation PP optimizes weight reduction compared to a standard          single support.      NSN: The number of subjects required was evaluated from our previous work (2013 Hokayem et     al.) Whose main objective was to assess the impact of PD versus placebo in first degree     relatives of patients with diabetes type 2. Under a bilateral alternative hypothesis of a     nonparametric test (Mann-Whitney), 1: 1 ratio, a power of 80% and an alpha risk of 0.05, the     number of subjects was estimated at 15 per group.      Methodology: Anthropometric measurements, assessment of body composition (DEXA) system     application characterization (metabolism, inflammation, oxidative stress, adipokines and     insulin sensitivity: clamp hyperinsulinemic-euglycemic, lipopolysaccharides: LPS) / tissue     characterization (biopsies of skeletal muscle and tissue adipose): insulin sensitivity,     inflammation, oxidative stress, gene regulation (sirt1), mitochondrial activity / cell     characterization (adipocyte precursor and muscle) insulin sensitivity, inflammation,     oxidative stress, sirt1.      Investigators hope to demonstrate that a non-pharmacological treatment based on nutritional     doses of PP supplementation can improve insulin sensitivity in insulin-resistant obese     patients, refer to optimize weight loss compared to a standardized management of obesity and     determine the mechanisms involved.   "
49863|NCT02633137|"     The purpose of this study is to find out what effects, good and/or bad, the treatment     including 1) Lenalidomide-RCHOP, 2) R-HIDAC, and 3) Lenalidomide-Rituximab maintenance has on     the participant and their lymphoma.   "
49864|NCT02633124|"     This study evaluates the potential interest of a new multi-lumen infusion access device     (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when     administering injectable drugs in premature infants. This device will be compared to the     standard infusion set of each center.   "
49865|NCT02633111|"     The purpose of this study is to determine whether a blood test can accurately detect whether     if the participant's lymphoma has come back after completion of initial chemotherapy     treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to     see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy     in the future.   "
49866|NCT02633098|"     This study evaluates the safety and effectiveness of pre-operative artesunate given orally     once a day for 14 days prior to surgery in patients with Stage II/III colorectal cancer.      Artesunate is an established antimalarial drug with an excellent safety profile, is well     tolerated and affordable. A number of laboratory studies and one small pilot clinical study     in patients with colorectal cancer have shown that artesunate can reduce the activity of     cancer cells.      Two hundred patients diagnosed with operable colorectal cancer will be randomly allocated to     receive oral artesunate 200mg daily or a matching placebo for 14 days prior to surgery.     Patients will be followed up closely for 5 years to see if giving artesunate preoperatively     reduces the risk of cancer returning after treatment.   "
49867|NCT02633085|"     The purpose of this study is to determine if there is a patient satisfaction preference of     Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who     are at a minimum two years post operative. Patient reported outcomes and expectations will be     analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile     Bearing UKA in one or both knees.   "
49868|NCT02632994|"     This study is for patients who have participated in a previous study and who continue to     receive benefit to have continued access to study drug and/or treatment.   "
49869|NCT02632981|"     Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of     pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have     reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32     expression compared with the unstimulated cells in monocytes (THP-1 cells). They suggested     that IL-32 may contribute to the pathogenesis of periodontal disease. In the present study     the investigators hypothesized that IL-32 levels may increase in the gingival crevicular     fluid (GCF) and saliva of patients with chronic periodontitis compared with healthy controls     and these levels may decrease together with treatment.   "
49870|NCT02632968|"     Pinhole surgical technique is a novel minimally invasive, predictable, efficient, time and     cost-effective technique for treatment of multiple gingival recession. This procedure     involves no releasing incision, suturing or sharp dissections. It has been shown that the     greater post-operative displacement of gingival margin may cause greater root coverage. Based     on this hypothesis, a split mouth randomized controlled clinical trial was planned to compare     the clinical outcome of pinhole surgical technique with and without the use of orthodontic     buttons and sutures in the treatment of multiple gingival recessions.   "
49891|NCT02632695|"     The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health     (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill,     population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled     accelerometer and tracking device (BEAT) worn on the foot during a progressive and     evidence-based non-exertive leg conditioning activities for lower leg function (CALF)     captures minute foot movements and sends the data to a Smartphone. This six-week feasibility     study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote     patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on     functional outcomes in a very low fitness population.   "
49892|NCT02632682|"     Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with     Conventional Histology for the Identification of Specialized Intestinal Metaplasia   "
49871|NCT02632955|"     Hemodialysis (HD) remains the most prevalent form of renal replacement therapy (RRT) for     patients with End Stage Renal Disease (ESRD). Loss and dysfunction of vascular access is a     significant contributor to morbidity in ESRD patients on HD. The National Kidney Foundation's     Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines suggest that all ESRD patients     should initiate dialysis with a functioning permanent vascular access with arteriovenous     fistulas (AVF) preferred over arteriovenous grafts (AVG). Central venous catheters (CVC) are     the least preferred vascular access for HD due to the complications associated with them.     Despite these recommendations, up to 80% patients start dialysis with a CVC. One of the     reasons for low AVF rates is early fistula failure (EFF). The most important causes for EFF     amenable to intervention is stenosis anywhere in the circuit. Endovascular approach has shown     a high rate of technical success in the treatment of stenotic lesions related to HD     arteriovenous access. Percutaneous balloon angioplasty (PBA) is considered the treatment of     choice for these lesions. Despite good technical and immediate success PBA has poor long term     outcomes with recurrence rates of 60-70% at 6 months. One of the reasons could be the damage     caused by angioplasty itself leading to intima-media rupture promoting the cascade of events     leading to further development of neo intimal hyperplasia (NIH). Recently the use of covered     stents at the time of angioplasty has shown better patency rates at 6 months but still not     optimal. Lately the development of drug eluting stents and drug eluting balloons (DEB) have     shown considerable advantage in clinical trials related to coronary and peripheral arterial     disease angioplasty. In a randomized control trial, the researchers are planning to assess     the efficacy of DEB angioplasty as compared to standard PBA in AVF's with EFF.   "
49872|NCT02632942|"     Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in     significant morbidity amongst patients with End Stage Renal Disease (ESRD), causing a severe     economic burden on any health care system. Native arteriovenous fistula (AVF) is the     preferred form of permanent dialysis access since it is associated with the best long term     outcome as compared to other forms of dialysis access. Despite the clinical benefits, many     patients on HD do not have AVF as there dialysis access. One of the reasons for low AVF rates     is early fistula failure (EFF). The two most important causes for EFF amenable to     intervention are stenosis anywhere in the circuit and/or presence of accessory vein (av).     Although management of stenosis is well established with relatively clear guidelines, the     management of av lacks clear scientific approach. In a recent study researchers recommended a     hemodialysis arteriovenous flow quantification-diameter (HAQ) criteria for accessory vein     obliteration. The purpose of this controlled, blinded, prospective trial is to assess the     clinical utility of the HAQ criteria as compared to current recommendations for av     obliteration.   "
49873|NCT02632929|"     The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and     reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have     diabetes and foot sores (also sometimes called ulcers or wounds).   "
49874|NCT02632916|"     The aim of this study is to acquire preliminary, pilot data over a 1-year period on the     safety and efficacy of subcutaneous denosumab versus the current CHEO standard-of-care     (intravenous zoledronic acid) for the treatment of osteoporosis in children. Both denosumab     (1.0mg/kg) and zoledronic acid (0.025mg/kg) will be given as two doses separated by a six     month interval (i.e. at baseline and 6 months), with follow-up to 1 year.   "
49875|NCT02632903|"     This study explores the effect of zoledronic acid on incident vertebral fractures and     osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.   "
49876|NCT02632890|"     The purpose of the study is to determine a) if the implementation of abatacept (Orencia®)     patient alert card (PAC) resulted in effective understanding of key safety messages and b) if     the degree of understanding of key safety messages is associated with improved clinical and     safety outcomes.   "
49885|NCT02632773|"     Improving social communication outcomes for children with autism spectrum disorders (ASD) has     important public health implications. The proposed research is a randomized controlled trial     of 108 children with ASD that examines how specific parent characteristics influence outcomes     of two different parent-mediated language interventions. Evaluating effective language     intervention strategies for children with ASD supports NIDCD's mission of behavioral research     aimed to remediate the disordered process of language development in children with ASD.   "
49877|NCT02632877|"     Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like     neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene,     diet and life style.      DFU results as a complication in diabetic patients and it is the most common cause of     non-traumatic foot amputation in people older than 50 years. Foot amputation decreases     patients´ quality of life since only 33% of them will continue walking with the use of a     prothesis.      However, 30% of patients subjected to amputation will die in the first year after surgery and     by the 5th year, post-surgery 50% of them will need the amputation of the remaining body     extremity.      According to the World Foundation for Diabetes, in Latin America there are 18 million people     with Diabetes Mellitus Type 2 (DM2). This number will increase in the next 20 years to 30     million.      Medical expenses for diabetic patients are calculated to be around 8,000 million dollars,     annually. In Mexico, according to the Mexican Federation for Diabetes there are 6.5-10     millions of diabetic patients.      Amputation due to DFU complications has many social and economic implications. In Mexico in     2011 diabetes mellitus complications were the principal cause of death in the institute of     mexican social security (IMSS) population.      On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone (PFD) is considered an anti-inflammatory     drug that promotes re-epithelization due to fibroblast stimulation, angiogenesis and     vasculogenesis during tissue remodeling.      According to this, the investigators believe that PFD could play an important role in DFU     resolution and for this reason, the investigators consider necessary to analyze the efficacy     of 5-methyl-1-phenyl-2-(1h)-pyridone for the treatment of DFU since it has showed improvement     in chronic skin ulcers in pilot studies.      Nowadays, DFU treatment includes management of metabolism, angiopathy and neuropathy along     with broad-spectrum antibiotic therapy. However, several reports indicate it is insufficient     for and adequate control of diabetic patients.      Then, it is important to develop efficient therapies for the treatment of DFU. In this     context, Ketanserin (Sufrexal™) is a drug to induce scar formation. It has been demonstrated     to decrease peripheral vascular resistance, platelet aggregation and improves hemorheologic     parameters.      Topical administration of ketanserin has showed beneficial effects in inflammation,     granulation and epithelization.      Since these two drugs have showed beneficial effects in tissue regeneration, the     investigators believe it is important to compare their safety and efficacy for the treatment     of DFU   "
49893|NCT02632669|"     This clinical study will evaluate side effects, quality of life and cancer control in     patients with prostate cancer diagnosed on only one side of the prostate gland.      The diagnosis of unilateral prostate cancer will be made by means of a prostate transperineal     template biopsy (TTB) and multiparametric magnetic resonance imaging (mpMRI).      Patients will be treated with low dose rate brachytherapy, using permanent iodine seed     implants.Treatment will be limited to the side of the gland where the cancer has been     diagnosed and is therefore called focal brachytherapy.      Prostate brachytherapy is usually applied to the whole prostate gland. After whole gland     prostate brachytherapy urinary, bowel and sexual function may be affected. In this focal     approach, the side effects will be evaluated by means of patient questionnaires.These will be     repeated at various intervals after treatment.The results will be compared to the same     questionnaires responded by patients who have undergone whole gland brachytherapy.Therefore     an assessment can be made whether focal therapy produces fewer side effects than whole gland     brachytherapy.The observation period will last for two years after treatment. A biopsy and     mpMRI will be repeated after two years to evaluate prostate cancer control.   "
49878|NCT02632864|"     The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial     chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit     in several randomized phase III trials, the benefit was modest.      Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT     techniques, showed favorable response rate with acceptable local control rate. Based on those     promising results, RT was actively applied in HCC who are not indicated with surgery and/or     radiofrequency ablation.      Many researchers reported that there is a relationship between RT dose and tumor response     rate. RT dose, however, is frequently limited because the complications (like radiation     induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also     closely related with higher exposed RT dose.      Proton beam has characteristic depth-dose distribution contrast to photon, the Bragg peak.     The advantage of this dose distribution could be more highlighted in HCC management, because     of the weakness and maintenance importance of liver function itself in HCC patients. In fact,     the superior results of proton beam therapy in HCC were constantly reported in several groups     as prospectively as well as retrospectively.      In this background, the investigators planned the present study to evaluate the efficacy and     safety of proton beam therapy in HCC patients who are not indicated with surgery and/or     radiofrequency ablation (RFA).   "
49879|NCT02632851|"     This observational, non-interventional multicentric study compares the inhalation therapy on     patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin     inhalation solution and Pari NaCl (0.9%) inhalation solution   "
49880|NCT02632838|"     Monitoring and self-management are important components of effective chronic disease care and     improved patient outcomes. With the rapid development of integration of mobile health     technology (mHealth) into health care delivery services, mHealth intervention provides a     great opportunity to improve the efficiency of chronic disease management. However, little is     known about whether mHealth interventions can effectively impact the health and health care     outcomes in underserved populations. This pilot study will assess the preliminary     effectiveness of a mobile-based health intervention in an urban underserved community with a     high incidence of hypertension. It is hypothesized that patients with hypertension will     experience improved outcomes due to the use of a mHealth application compared with patients     who are not using the application. The findings from this study will advance our     understanding of the utility of mHealth interventions among underserved populations and     generate evidence to support this new health care delivery approach in underserved urban     communities.      In this study, three hypotheses will be tested:        1. Hypertension patients using the mHealth application exhibit a greater decrease in blood          pressure and better maintenance over a 6-month period compared to those who receive          standard care.        2. Hypertension patients using the mHealth application will exhibit more effective          self-management as compared to those who receive standard care.        3. Utilizing the mHealth application helps nurses to monitor hypertension status more          effectively than monitoring hypertension status without the mHealth application.   "
49881|NCT02632825|"     Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and     often produce similar clinical outcomes. It has been shown in adults that NHF produce     different effects on ventilation during wakefulness and sleep. There is no physiological data     on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake     status.   "
49882|NCT02632812|"     This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if     rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24     participants (12 per treatment group), male or female, aged 18 years-old and above.      Primary objective is to compare rebamipide effervescent granules 100 mg twice daily, plus     naproxen (coated tablets) 550 mg twice daily to placebo plus naproxen 550 mg twice daily, for     seven days, in reduction of gastric events caused by naproxen. Secondary objective is to     evaluate safety and tolerability of rebamipide after multiple administrations.      Participants will receive either rebamipide + naproxen or placebo + naproxen, as above,     during 7 consecutive days, which will be accompanied by a follow-up visit.      Gastric integrity will be assessed, before and after treatment, by endoscopy, with stomach     biopsies and detection of H. pylori. Additionally, detection of occult blood in the stool     will be performed, before and after treatment.      From the above-mentioned biopsies, dosage of prostaglandin E2 and histopathological analysis     will be performed.   "
49883|NCT02632799|"     Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and     often produce similar clinical outcomes. The aim of the study was to investigate airway     pressure during NHF and CPAP in neonates.   "
49884|NCT02632786|"     This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled,     two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered     intravenously in adults with AL amyloidosis who had a hematologic response to previous     treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT])     and have persistent cardiac dysfunction.   "
49888|NCT02632734|"     Normally, dentists do not graft the socket after extraction of teeth. When they do graft they     use particulate graft devices. The purpose of this study is to examine whether coral     particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will     preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth     extraction. The coral grafting devices are processed from Porites corals grown in aquariums,     under controlled environment. The devices are cleansed and sterilized by gamma irradiation.     The measurements during follow ups will be performed from CT x rays and measurements by     caliber and models.The width and height measurements from follow up x rays and models. The     study will be performed on 10 patients, that two parallel teeth are diagnosed to be     extracted, in same patient.The data will be analysed for bone loss and compared to previous     published studies. Also comparison between two devices will be performed.   "
49889|NCT02632721|"     Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose     for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and     efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is     to collect additional data on safety, pharmacokinetics and efficacy and to define the     Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.      Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI     836858 in combination with decitabine compared to decitabine monotherapy.   "
49896|NCT02632630|"     Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than     well-nourished patients, and carry a 30-day readmission rate of >46%. Although malnutrition     is common and is associated with extremely poor outcomes, it is neglected and undertreated.     This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical     patients, and then provide nutritional supplementation in hospital and after discharge for 28     days. In select at-risk patients, 5 days of nutrition delivered through a peripheral vein     will be used in addition to oral nutritional supplementation.   "
49897|NCT02632617|"     Preoperative detection of combined coronary artery disease by invasive coronary angiography     (ICA) is recommended in American Heart Association (AHA)/American College of Cardiology (ACC)     guidelines for most patients (>40 yrs male or postmenopausal female) scheduled for heart     valve surgery, but the low incident rate of coronary artery disease implied guidelines for     the vast majority who ultimately will not undergo revascularization. Computed tomography     angiography (CTA) has emerged as an alternative diagnosis procedure, which has the following     advantages: non-invasive, low cost, provide information of lung and mediastinum. Our study is     to evaluate the feasibility of computed tomography, instead of conventional invasive coronary     angiography in evaluating coronary artery lesion prior to the heart valvular operation.   "
49901|NCT02632552|"     Transition from hospital to home places patients in jeopardy of adverse events and increases     their risk for rehospitalization. CHF is the most prevalent chronic condition among U.S.     adults and COPD is the third leading cause of death in the U.S. Both CHF and COPD represent     significant burdens for the VHA healthcare system. Care transitions can be supported through     multi-component interventions, but are costly to implement. Virtual nurses provide an     effective medium for explaining health concepts to patients, and previous work indicates     patients find virtual nurses acceptable. The investigators will implement and evaluate a     virtual nurse intervention to provide automated, tailored, and timely support to Veterans     transitioning from hospital to home. As effective care transition interventions incorporate     both inpatient and outpatient components, the virtual nurse will first engage with patient     onscreen during their inpatient stay and then via text message post-discharge. This project     has the potential to improve the care transition experience for patients, caregivers and     healthcare providers.   "
49902|NCT02632539|"     Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients     who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic     space is a well-proven cause of VAP. Investigators invented a manual method with high-flow     air produced by resuscitator to impinge secretion from the subglottic space to oral cavity.     Investigators want to compare it with conventional method which uses a special intubation     tube with an independent dorsal lumen to suction subglottic secretion.   "
49903|NCT02632526|"     This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single     and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to     assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy     male subjects   "
49904|NCT02632513|"     The aim of this study was to compare the success after endodontic treatment performed with or     without continuous ultrasonic irrigation.      70 Mandibular molars with diagnosis of pulpal necrosis and with periapical radiolucency were     randomly assigned into two treatment groups- continuous ultrasonic irrigation (CUI) and     syringe irrigation (SI). Standard nonsurgical endodontic treatment was performed on both     groups under rubber dam isolation with 0.02 taper ISO stainless steel hand files using step     back technique. In both groups, 5 ml of 5.25% sodium hypochlorite was used as irrigant after     each instrument. After root canal instrumentation, canals were irrigated with 5 ml of 17%     EDTA solution for 1 minute. In SI group, canals were flushed with 15ml of 5.25% sodium     hypochlorite using a 27 gauge needle while final irrigant was delivered using a continuous     ultrasonic irrigation device in CUI group. An inter-appointment dressing of calcium hydroxide     was given and patient was recalled after one week and canals were obturated with the Gutta     Percha. Immediate postoperative radiograph was then taken, followed by radiographs at 3, 6, 9     and 12 months.   "
49905|NCT02632500|"     The aim of the study is to verify whether the inclusion of breaks of different frequency and     duration during the hands-only cardio-pulmonary resuscitation (CPR) could increase chest     compressions quality during an 8-minutes scenario.   "
49906|NCT02632487|"     This study will evaluate the feasibility and efficacy of combining a traditional, structured     exercise intervention with an innovative intervention designed to decrease sedentary behavior     and increase non-exercise physical activity (NEPA).   "
49907|NCT02632474|"     The purpose of this study is to determine efficacy of the combination of low dose of     Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.   "
49908|NCT02632461|"     The purpose of the study is to test the effectiveness of two different weight loss     interventions. Both of these interventions will provide weight loss information through twice     weekly audio podcasts. In addition to the podcasts, participants will be asked to track their     diet using either a wearable device on their wrist or through an app on their smartphone.   "
49909|NCT02632448|"     The main purpose of this two-part study is to evaluate the safety and efficacy of the study     drug known as LY2880070 in participants with advanced or metastatic solid tumors.   "
49910|NCT02632435|"     In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel     method to allow comparisons of established standard of care vascular access strategies using     the integrated consent model as part of a pragmatic clinical trial. The investigator wishes     to address a non-pharmacologic issue regarding standard of care vascular access devices.     Peripherally inserted central catheters (PICC lines) versus subcutaneously implanted devices     (PORTs).   "
49911|NCT02632422|"     The purpose of this study is to determine how the nervous system controls leg muscles is     important for walking in subjects following a spinal cord injury (SCI) and how they may be     affected by brief periods of low oxygen inhalation over time.   "
49912|NCT02632409|"     The purpose of this study is to determine the effectiveness and safety of Nivolumab compared     to placebo in participants who have undergone radical surgery for invasive urothelial cancer.   "
49960|NCT02631642|"     The purpose of this study is to evaluate the safety and tolerability of a single dose of     HMPL-689 in healthy volunteers To determine the pharmacokinetic profile of single oral doses     of HMPL-689 in healthy volunteers   "
49915|NCT02632370|"     In support of the US marketing application for 5-ALA, this single arm trial is being     conducted to establish the efficacy and safety of Gliolan (5-ALA) in patients with newly     diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan (5-ALA), as     an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with     malignant histopathology. The primary objective in this single arm study is to define the     positive predictive value (PPV) of Gliolan-induced PPIX fluorescence for malignant tumor at     the time of initial resection and first use of FGS by taking a biopsy of tissue presenting     with red fluorescence when observed during the course of resection of new or recurrent     malignant gliomas. The functionality and performance reliability of the blue light excitation     microscope platforms will be assessed.   "
49916|NCT02632357|"     Study Design: Longitudinal Experimental Study      Objective: Analyze the relationship between Upper Limb Neural Tension Test (ULNTT1) and     cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing     model based on Least Square Approximation.      Summary of Background Data: ULNTT1 is a test able to determine cervical nerve roots and     brachial plexus displacement within their interface structures. No studies were conducted     about ULNTT1 and cervico-thoracic spine motion patterns relationship.      Methods: 12 subjects with ULNTT1 asymmetry > 10° (AS group) and 11 subjects with ULNTT1     symmetry (S group) at clinical tests will be enrolled for the study. Subjects will be     analyzed for ULNTT1 with an electrogoniometer using two parameters, one operator and one     patient-dependent. Fine lateral bending cervico-thoracic spine motion patterns will be     collected with motion-capturing technique and data will be analyzed with Least Square     Approximation tools. Subjects with impairments in cervico-thoracic spine mobility will     undergo to correction of those with spinal manipulative therapy. ULNTT1 and spine mobility     will be so re-evaluated with same methods.   "
49917|NCT02632344|"     This research study is evaluating an immune modulatory agent as a possible treatment for     patients with Recurrent Respiratory Papillomatosis (RRP) with significant disease involving     the larynx, trachea, and/or lungs. The investigators will be using Pembrolizumab as the     treating agent.   "
49918|NCT02632331|"     The objective of this study is to evaluate the effect of food on the pharmacokinetics and     safety after administration of ASP8825 in healthy non-elderly adult male subjects.   "
49919|NCT02632318|"     One of the most physiologically demanding things that older people do every day is to get up     in the morning. After spending a night laying flat, where the blood distributes evenly across     the body, when they stand in the morning (and the blood rushes to their feet), their     cardiovascular system may not be able to compensate and maintain blood flow to the brain.     This phenomenon is known as orthostatic or postural hypotension. The investigators have found     in a group of young individuals that use of a dawn-simulation light that gradually wakes the     brain is able to increase cardiovascular tone prior to arising. The goal of this experiment     is to determine whether this dawn simulation light is able to increase cardiovascular tone in     older adults such that they would have reduced or absent postural hypotension when they     awaken in the morning. This would greatly reduce the risks of falls and their associated     morbidities in older adults.   "
49920|NCT02632305|"     There is increasing evidence that there is a large degree of pathologic homology between the     pancreas and biliary tract. Indeed, the biliary tract has been referred to as an incomplete     pancreas and embryologically the two originate from the same structure. It is thus plausible     that oncogenesis in the pancreas and biliary tract are related and that pancreas and biliary     cancers have reciprocal effective treatment strategies.      To date, the only chemotherapeutic agents effective in advanced biliary tract tumors is the     combination of gemcitabine and cisplatin. Known and approved therapies for advanced pancreas     cancer include single agent gemcitabine, the four drug combination of FOLFIRINOX     (5-fluorouracil, leucovorin, oxaliplatin, and irinotecan), the questionable limited benefit     of inhibiting the epidermal growth factor receptor pathway, and most recently the combination     of gemcitabine and nab-paclitaxel.      Based on promising results in pancreas cancer, investigators hypothesize nab-paclitaxel in     combination with gemcitabine + cisplatin will be an effective cytotoxic combination in BTC     treatment.   "
49921|NCT02632292|"     Prospective, randomized, controlled, multicenter, open-label study to compare     everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients     with diabetes mellitus.   "
49922|NCT02632279|"     The purpose of this study is to assess the effect of tryptophan depletion on mood and     behavior in Parkinson's disease (PD) patients treated with deep brain stimulation (DBS) of     the subthalamic nucleus (STN). By doing this, the investigators hope to be able to identify     risk factors for and mechanisms underlying psychiatric side effects of STN DBS. The study     will be an intervention study with a placebo controlled, randomized cross-over design.   "
49923|NCT02632266|"     The purpose of this study is for the researchers to examine the safety and efficacy of liquid     human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk     fortifier.   "
49924|NCT02632253|"     Patients with congenital heart disease have long been discouraged from participating in     physical exercise which has led to impaired exercise capacity in this population. Since low     physical and cardiorespiratory fitness has been shown to be a predictor for hospitalization     and mortality in grown-up patients with congenital heart disease (GUCH), aerobic endurance     training has been recommended recently to improve exercise capacity. The aim of this study is     to compare two types of training, namely high-intensity interval training (HIIT) and     moderate-intensity continuous exercise (MICE), with regard to improving exercise capacity     without adverse effects on heart structure, function and rhythm in the setting of a 12-week     outpatient cardiac rehabilitation (CR) program in GUCH with a remaining pathology involving     the right and/or left ventricles. Primary endpoint will be change in exercise capacity     (maximal oxygen consumption) over the 12-week CR. Secondary endpoints will be changes of the     right or left ventricles as well as vascular function.      Patients with GUCH and reduced function of the right ventricle will be recruited and informed     about the study within the first two weeks of CR. At the end of week 3 of the CR with     supervised MICE, randomization to 9 weeks of twice weekly either HIIT or MICE takes place.      MICE training is performed at an intensity of 70-85% of maximum heart rate (HRmax) for 38     min. HIIT consists of four 4 min bouts of high-intensity exercise (90-95% of HRmax),     interspersed by 3 min low-intensity intervals (50-60% of HRmax). All patients complete one     additional endurance activity per week in their own time with a duration of 30-60 min at     moderate intensity monitored by their smart phone.      Change in peak oxygen uptake as well as maximal exercise capacity at the end of an     incremental cardiopulmonary exercise test will be assessed between week 3 and 12. Vascular     function will be assessed at the same time. Volumes and function of the right and left     ventricles will be measured by cardiac magnetic resonance imaging (CMR) upon inclusion into     the study and at completion of the intervention. Furthermore, laboratory markers for heart     failure as well as occurrence of irregular fast heart beats will be assessed.   "
49961|NCT02631629|"     This project aims at proving the efficacy and safety of food based solutions to prevent     vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in     Denmark.   "
49925|NCT02632240|"     The aim of this study is to compare the efficacy of dental root coverage using the tunnel     technique with connective tissue graft (CTG) and the same technique with collagen matrix for     treatment of multiple gingival recessions Miller Class I and II.      This study is a randomized-controlled clinical trial of 6 months duration.   "
49926|NCT02632227|"     The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel     ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart     surgery.   "
49927|NCT02632214|"     The aim of this study is to evaluate cerebral asymmetry for face processing in a group of     profoundly deaf participants and a group of hearing controls by the mean of fMRI measure. To     this end, we present chimeric faces (faces split into different halves), entire faces, or     faces presented in divided visual field, and subjects perform a gender categorization task     while lying in a fMRI scanner.      It is expected to find a reduced cerebral asymmetry in the Fusiform Face Area in deaf in     comparison with hearing participants.   "
49928|NCT02632201|"     Objectives:      The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the     treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.      Methods:      This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver     metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic     cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both     DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total     of three periods. The mail clinical indicators are Progression-Free-Survival and Overall     Survival.   "
49929|NCT02632188|"     Objectives:      The purpose of this study is to evaluate the safety and efficacy of radical surgery combined     with dendritic cell-precision multiple antigen T cells in reducing the recurrence and     metastasis of liver cancer      Methods:      This study designs a novel therapy using dendritic cell-precision multiple antigen T cells.     60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly     divided into postoperative routine therapy group and dendritic cell-precision multiple     antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision     multiple antigen T cells treatments will be performed every 3 weeks with a total of three     periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.   "
49930|NCT02632175|"     This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects     with ulcerative colitis.   "
49931|NCT02632162|"     Sleep disordered breathing (SDB) is common in cardiovascular patients. Patients after cardiac     surgery will be screened for SDB with the ApnoeLink device at the beginning of cardiac     Rehabilitation and then after 3 weeks and 3 months.   "
49932|NCT02632149|"     The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve     stimulatior in children with Lennox-Gastaut Syndrome.   "
49933|NCT02632136|"     A newly developed technique of TAP block solely performed by surgeons will be used for     postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal hernia     repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better than the     periportal wound infiltration in controlling the postoperative pain.   "
49934|NCT02632123|"     Idiopathic pulmonary fibrosis (IPF) is a progressing scarring disease of the lungs with an     average survival of only 30-36 months since the time of diagnosis. The clinical course of IPF     is highly variable, with some patients remaining stable for a prolonged period of time, even     in the absence of medical treatment, while others experience rapid and relentless     progression. In some cases, the clinical course consists of a stepwise rather than steady     decline, with periods of stability alternating with acute respiratory worsening. The     variability in clinical course makes it challenging to define prognosis in these patients     and, importantly, to determine the right time window for lung transplantation (LTx) referral,     listing and priority status on the waiting list.      The risk stratification score (RISE) is a new staging system for IPF based on the MRC dyspnea     score, on physiology variables (pulmonary function tests) captured in the Composite     Physiologic Index (CPI), and on the 6-minute walk distance. RISE showed to predict survival     in newly diagnosed patients with IPF better than any other individual clinical, functional or     radiographic variable. RISE also predicted survival on the waiting list in patients assessed     and listed for LTx.   "
49935|NCT02632110|"     The purpose of this study is to determine the viability of microneedle lesion preparation     (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis     (AK) field on the face.   "
49936|NCT02632097|"     This is a prospective, randomized double-blinded study to find out if mesh fixation with     n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures     in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is     that glue fixation is safe, simple and fast method compared to conventional Lichtenstein     technique.   "
49937|NCT02632084|"     A study to followup patients that have previously been treated for pituitary tumours with     either photodynamic therapy or placebo in a previous trial. The study aims to determine     whether photodynamic therapy has any long term effect on tumour size, visual fields or     endocrinological function.   "
49938|NCT02632071|"     This is a non-randomized phase 1 trial designed to determine the MTD and evaluate the safety     and tolerability of ACY-1215 with nab-paclitaxel. Based on the activity profile of ACY-1215     in breast cancer, corresponding biomarker availability with the HDAC6 MR score, and its     potential synergy with taxanes, these data support the rationale for testing the ability of     ACY-1215 to improve the response rate for patients with metastatic breast cancer in     combination with standard taxane chemotherapy.   "
49939|NCT02632058|"     Tinnitus is the acoustic perception of sound without any physical source. It is estimated     that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation     in all aspects of daily life of the affected.      There is currently no evidence for a successful treatment of tinnitus. While one treatment     approach involves sound-based therapies, e.g. tinnitus retraining therapy. The treatment     aspect in our setting involved cognitive behavioural therapy.   "
50239|NCT02627989|"     This study intends to investigate patient satisfaction of treatment with Ointment (W/O     emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic     dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction,     treatment adherence, itchiness, and AD severity scores.   "
49940|NCT02632045|"     This is a randomize trial for patients with metastatic hormone receptor (HR)-positive human     epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an     aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either     fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to     determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at     the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar     toxicity and drug profile and mechanism of action, we feel that it is appropriate for     patients to receive either drug with an aromatase inhibitor prior to randomization.   "
49941|NCT02632032|"     Therapeutic education is central to the management of diabetes, especially in children and     adolescents. Camps represent an ideal environment for education. During camps, the campers     receive both theoretical and practical information intended to improve their understanding     and self-management of diabetes. The metabolic impact of diabetes camp is little known among     children and adolescents living with type 1 diabetes in sub-Saharan Africa. The aimed of this     study was to assess the changes in glycemic control and insulin doses in a group of children     and adolescents living with type 1 diabetes in Cameroon during and after camp.   "
49942|NCT02632019|"     Objectives:      The purpose of this study is to evaluate the safety and prognosis of dendritic cell-precision     T cell for neo-antigen in the treatment of advanced biliary tract malignant tumor.      Methods:      This study designs a novel therapy using dendritic cell-precision multiple antigen T cells.     40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic     cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine treatments     will be performed once a week with a total of six times. Dendritic cell-precision T cell for     neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a total of six     times before 60 days prior to the start of drawing blood. Dendritic cell-precision T cell for     neo-antigen: once per 3 weeks with a total of three periods. The mail clinical indicators are     Progression-Free-Survival and Overall Survival.   "
49943|NCT02631863|"     This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for     the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).   "
49944|NCT02631850|"     The current proposal aims to conduct a multi-site randomized controlled trial comparing     virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1)     traditional clinic-based CI therapy of equal total active therapy duration and (2) a control     group equating the dose of in-person therapy. Individuals with chronic stroke will be     randomized to one of four different interventions: (1) traditional clinic-based CI therapy     (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy     (5 therapist/client contact hours in the clinic and 15 hours of independent game play at     home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist     contact via telerehabilitation (5 therapist/client contact hours in the clinic, 4 therapist     contact hours via teleconference, and 15 hours of independent game play in the home), and (4)     5 hours of standard occupational therapy. After 6-month follow-up, individuals assigned to     standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone     application of the rehabilitation game without additional therapist contact).   "
49945|NCT02631837|"     Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and     established total laparoscopic hysterectomy for successful removal of a non-prolapsed uterus     in women due to undergo hysterectomy for benign gynecological pathology.      Study design: Randomized controlled/single     center/single-blinded/parallel-group/non-inferiority/efficacy trial.      Study population: All women aged 18 to 70 years regardless of parity with a non-prolapsed     uterus and a benign indication for hysterectomy.      Randomization: Women will be randomly allocated to undergo one of two techniques for removal     of the uterus immediately before surgery by using a computer generated randomization list. We     will use stratified randomization according to the estimated uterine size on clinical     examination.      Intervention: Women will be treated by a surgeon who is not blinded to the treatment     allocation and who is equally skilled in performing both techniques. In the intervention     group a vNOTES technique will be used.      Control: In the control group surgery will be done by a classical laparoscopic technique.      Main study parameters/endpoints:      Primary study outcome parameters: successful removal of the womb with the intended approach     without conversion to an alternative approach.      Secondary outcomes: the proportion of women admitted to the in-hospital ward for at least one     night observation, based on their own preference; postoperative pain scores using a VAS     (Visual Analogue Scale) measured between day 1 till 7 by the participating women following     surgery and the total amount of analgesics used as described in the standardized pain     treatment protocol from day 1 till 7; postoperative infection defined by lower abdominal pain     with fever > 38°C and positive clinical signs or laboratory findings; per- or postoperative     complications according to the Clavien- Dindo classification detected during the first six     weeks of surgery; hospital readmission within 6 weeks following surgery; duration of the     surgical procedure; incidence and intensity of dyspareunia recorded by the participants at     baseline, 3 and 6 months by self-reporting using a simple questionnaire and VAS (Visual     Analogue Scale); sexual wellbeing recorded by the participants at baseline, 3 and 6 months by     SSFS (Short Sexual Functioning Scale); health-related quality of life, at baseline, at 3 and     6 months by self-reporting the EQ-5D-3L questionnaire; direct and indirect costs incurred up     to 6 weeks after the hysterectomy associated with both procedures.   "
49946|NCT02631824|"     Randomized clinical trial to assess if the use of augmentation in the treatment of fragility     intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged 65     years or older 1 year after surgery   "
49947|NCT02631811|"     Several studies have shown that patients with acute leukemia have many symptoms during     disease These symptoms decrease the quality of life and may even appear or worsen other     symptoms such as depression Several studies point to the involvement of supportive care and     palliative care is delayed in these patients The aim of this study is to evaluate the impact     on the quality of life of an early and standardized involvement of a support / palliative     care team for patients with acute leukemia in first relapse compared to a control group .   "
49948|NCT02631798|"     Previous with methylene blue suggested that oral administration may be superior to     conventional spray catheters. The main advantages claimed were better staining due to longer     exposure to the dye, more uniform staining due to normal position of the intestines (during     conventional chromocolonoscopy, patients are lying on one side), and a quicker and more     comfortable procedure for the patients and endoscopy personnel.      Using food-grade dyes would enable higher dye loads and lower systemic side effects.      Food grade dyes will be administered orally during preparation with KleanPrep (total amount     of 4 liters) in patients undergoing screening colonoscopy.      On day 1 patients will drink 3 l of the preparation solution, the last liter together with     the last dose of dye will be administered 5 hours before scheduled colonoscopy.      Primary endpoints:        -  quality of mucosal staining of colon (assessed by questionnaire)      Secondary endpoints:        -  adenoma detection rate        -  adverse events        -  time of colonoscopy   "
49949|NCT02631785|"     The proposed research aims to isolate brain-based information-processing mechanisms     implicated in perturbed fear learning and extinction characteristic of pediatric anxiety.      The study will focus on the therapeutic relevance of dysfunction in fear learning and     extinction for treatment by examining the associations between brain functioning and response     to exposure intervention in anxious children.   "
49950|NCT02631772|"     The predominant remaining questions for post-transplant treatment of HCV in the DAA era are     whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a     potential option to prevent long-term damage to the allograft.      Our aim is to provide answers to these primary questions with our multicenter, prospective,     randomized, open-label intent-to-treat phase IV study   "
49951|NCT02631759|"     Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in     France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48     hours). Currently, no urgent medical or surgical treatment has been shown to improve     functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral     haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical epileptic     seizures (detected on the electroencephalogram (EEG) only) could be much more frequent (28 %     to 40 %).      Some studies have suggested that early repeated epileptic seizures may be associated with a     worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may     increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain     tissue. Thus, prevention of early epileptic seizures may improve neurological outcome.     However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and     subclinical epileptic seizures has not been evaluated in the setting of intracerebral     haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only     when epileptic seizures occur.      Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of     systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute     supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence     of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter     EEG.      Secondary Objectives:This study also aims to assess:      Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures, on     the total duration of epileptic seizures continuously recorded on EEG, on the occurrence of     some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours of     diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months)     clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by the     modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing the     admission brain CT scan with the control CT scan performed at 72 hours, on the neurological     status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and     3 months and on the quality of life measured by the Stroke impact Scale at 3, 6 and 12     months.      Ä The frequency of side effects related to treatment with levetiracetam (anxiety and     depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample     Size: 104 patients will be recruited over 2 years.   "
49952|NCT02631746|"     This phase II trial studies how well nivolumab works in treating patients with human T-cell     leukemia virus (HTLV)-associated T-cell leukemia/lymphoma. Nivolumab is an antibody, which is     a type of blood protein that tags infected cells and other harmful agents. Nivolumab works     against a protein called programmed cell death (PD)-1 and may help the body destroy cancer     cells by helping the immune system to keep fighting cancer.   "
49953|NCT02631733|"     This phase I trial studies the side effects and best dose of veliparib when given together     with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and     veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
49954|NCT02631720|"     While many patients experience benefits from transplant, complications such as infections and     lung rejection may affect long term survival and quality of life. In this study doctors are     looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought     to be chronic rejection of the lung by the immune system and is the leading cause of death     after lung transplantation.      The purpose of this study is to help doctors determine:        -  why some people get CLAD and others do not        -  how patients who get CLAD do after CLAD is diagnosed        -  how CLAD may affect quality of life   "
49955|NCT02631707|"     All patients in CMDHB eligible for bariatric surgery are given a weight loss goal prior to     surgery. It is unknown what the most effective diet is to lose weight, while still preserving     muscle mass. The diet must also be acceptable and adhered to by patients. The aim of this     study is to find out if a diet that is higher in protein and lower in carbohydrate than the     standard Ministry of Health guidelines will have a greater effect on weight loss,     preservation of lean muscle mass, surgical recovery score, adherence and acceptability.   "
49956|NCT02631694|"     Animal and human fear conditioning studies have repeatedly shown that administering     propranolol before or after retrieval of a previously acquired fear results in an elimination     of the fear expression. This approach, known as disruption of fear memory reconsolidation, is     a promising new avenue for treating anxiety disorders. The present study aims to test its     efficacy in patients with panic disorder.   "
49957|NCT02631681|"     Exercise intervention for men with prostate cancer on androgen deprivation therapy.   "
49958|NCT02631668|"     IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia, the     doctor will prescribe ferrous succinate with or without vitamin C according to their own     preferences. In theory, only the divalent iron can be absorbed in duodenum and upper jejunum,     vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of     acidity in the intestine, and then promotes the absorption of iron. In current clinical     practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of     vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and     safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The     dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to     patients who meet the inclusion criteria, and these patients are followed up every two weeks.     On the one hand, whether the addition of vitamin C can accelerate the recovery of anemia is     evaluated, on the other hand, whether the addition of vitamin C can increase the incidence of     gastrointestinal tract discomfort is aslo appraised , the discomfort include vomiting,     nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C can increase     the absorption of iron and accelerate the recovery of anemia, it also increases incidence of     gastrointestinal adverse events because of increased iron absorption at the same time.   "
49959|NCT02631655|"     18F-FDOPA PET is expensive. It is mandatory therefore to assess its impact on the management     of patients with high-grade gliomas in order to provide medico-economic justification for its     use. The article by the UCLA group showed that 18F-FDOPA modified 41% of management decisions     for patients with brain tumors (Walter JNM 2012). However, this study comprised 58 patients,     combined primary and recurring tumors, and was based on questionnaires sent out to referring     physicians. A targeted study is needed, therefore, to make a prospective multicenter     assessment of the contribution of this technique in the context of high-grade glial tumors     and neurooncology MCCs.   "
49962|NCT02631616|"     Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of     neuroendocrine differentiation (NED). Recently the investigators initiated a research project     investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine     tumors-NET) in PET/CT in patients with CRPC. In 4/8 patients studied thus far, uptake of the     tracer in bone metastases was found. It has been shown that monthly injections of     Somatostatin lengthen overall survival in patients with NET. The purpose of the current     project is to examine the ability of Somatostatin to stabilize or possibly reverse metastases     in patients with CRPC that express high level of somatostatin receptors in 68Ga-DOTATET     PET/CT.      Materials and Methods: 30 patients with CRPC will be studied with 68Ga-DOTATET PET/CT.     Patients showing uptake of the radiotracer 68Ga-DOTATET in at two least to metastases will be     considered eligible for the study. These patients will be evaluated biochemically and     clinically and will be treated with monthly injections of Sandoatatin LAR - 30mg. Clinical,     biochemical and imaging studies (68Ga-DOTATET PET/CT) will be repeated after 4 and 12 months     of treatment. Responding patients (stabilization or decrease in the number and SUV of     metastases) will be subjected to continued therapy until progression.   "
49963|NCT02631603|"     Stop exogenous allergic alveolitis (EAA) in childhood: healthy into adulthood - a randomized,     double-blind, placebo-controlled, parallel-group study to evaluate prednisolone treatment and     course of disease.      The hypothesis of the study is that the treatment with placebo will not be inferior in terms     of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6     months treatment.   "
49964|NCT02631590|"     The purpose of this study is to see if an experimental drug, called copanlisib is effective     and safe in treating adult participants with cholangiocarcinoma, when used in combination     with gemcitabine and cisplatin.   "
49965|NCT02631577|"     This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of     induction treatment consisting of atezolizumab in combination with obinutuzumab plus     lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by     maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who     achieve a complete response (CR), a partial response (PR), or stable disease at end of     induction.   "
49966|NCT02631564|"     The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan     and raltitrexed with or without embolization by lipiodol or microspheres are effective in the     treatment of refratory liver metastasis from colorectal cancer.   "
49967|NCT02631551|"     Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to     individual monotherapies (comparators) as well as the efficacy of these monotherapies     (comparators) versus placebo NS over 14 days of study treatment   "
49968|NCT02631538|"     This study is a multi-national, multi-center, double-blind (sponsor open), randomized,     placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to     understand the safety and tolerability profile of belimumab/ rituximab co-administration and     of belimumab monotherapy; and to evaluate whether either co-administration therapy or     belimumab monotherapy has a substantive effect on disease activity.      This study will consist screening period, double blind treatment period, a general follow-up     period and individualized follow-up period. Approximately 70 subjects will be recruited into     the study initially. At Day 0, subjects will be randomized 1:2:2:2 to one of the four     treatment arms placebo arm, belimumab monotherapy arm, co-administration therapy arm and     rituximab monotherapy arm. Once a sufficient number of subjects have completed the Week 24,     interim analyses and sample size re-estimation will be conducted. The total number of     subjects randomized may increase following sample size re-estimation up to a maximum of 120     recruited into the study.      Subjects in all arms will receive investigational product (IP) until Week 52 (completion of     the treatment phase). All subjects will enter a 16-week general follow-up period after the     Week 52 visit or after discontinuation if a subject discontinues IP and withdraws from the     treatment phase visits prior to Week 52.      After completing the general follow-up period, subjects with cluster of differentiation     (CD)19+ B-cell levels below the lower limit of normal (or less than 90 percent [%] of     baseline, if baseline value was below lower limit of normal [LLN]) will enter an     individualized safety follow-up phase and return to the clinic for visits every 12 weeks with     monthly calls between visits to evaluate subjects for any serious adverse events (SAEs)     related to IP or study participation, fatal SAEs, and designated adverse event of special     interests (AESIs) (i.e., infections, malignancies, or depression, suicide/self-injury), and     to check concomitant medications.      The total duration of participation of a subject in this study will be approximately up to a     maximum of 2 years (i.e., up to Week 104).   "
49969|NCT02631525|"     Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative     recovery than remifentanil-propofol.   "
49970|NCT02631512|"     The aim of the current study is to support the performance and safety of Woulgan® in the     treatment of diabetic foot ulcer in comparison with the commercially available hydrogel     Intrasite. Healing and untoward medical events to be evaluated.   "
49971|NCT02631499|"     This study is designed to prospectively evaluate whether post-hepatectomy adjuvant     transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in     HCC patients with preoperative CTC ≥2.   "
49972|NCT02631486|"     Shoulder pain is among the most common musculoskeletal complaints, leading to high number of     General Practioners consultations in the United Kingdom. On the top list of the disorders     causing pain and dysfunction of shoulder is rotator cuff tears. The aetiology of rotator cuff     tears is multifactorial and is likely to be a combination of age-related degenerative changes     and trauma during life. It is present in approximately 25% of individuals in their 60s and     50% of individuals in their 80s and have been shown to start developing during the 40s. To     recover functional status of this patients group, surgical repair is often recommended, but     for optimal results the rehabilitation is of great importance and must be adequately planned.     After surgery a period of movement restriction is followed, however, the optimal time of     immobilisation is unknown. As a common practice, patients use a sling for six weeks and avoid     any activities with the affected shoulder. This period is important to protect the tendon,     allow good healing and to possibly prevent re-tear episodes. Although, the delayed motion may     increase the risk of postoperative shoulder stiffness, muscle atrophy and potentially delay     improvement of functionality. Based on the available evidence, it is difficult to make a     clinical decision for a well-programmed rehabilitation regime and establish the most     favourable postoperative time to start it. Moreover, it is not clear if early mobilisation     will benefit more severe stages as published studies have methodological flaws that     compromises the clinical decision for patients with higher commitments. The question whether     early mobilisation application is beneficial is of high importance as the results will not     just help improving patients quality of life, but also may reduce costs as further     complication may be avoided.   "
49973|NCT02631473|"     This study is an open-label, prospective pharmacokinetic study investigating two     antiretroviral agents in parallel and employing an adaptive design with two stages, whereby     the results obtained in the primary stage inform the doses selected for investigation in the     secondary stage   "
49974|NCT02631460|"     This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with     pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth     factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer     (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC     and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to     receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve     (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until     disease progression: pemetrexed or S1. The primary end point of this non-inferiority study     was progression free survival（PFS）   "
49975|NCT02631447|"     To evaluate the best sequencing approach with the combination of target agents (LGX818 plus     MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in     patients with metastatic melanoma and BRAF V600 mutation.   "
49976|NCT02631434|"     Comparison between sit-to-stand test and six minutes walking test in chronic obstructive     pulmonary disease patients   "
49977|NCT02631421|"     Right ventricular (RV) failure is the predominant cause of death in pulmonary arterial     hypertension (PAH). No RV-specific therapies are available, in part because the underlying     mechanisms of RV dysfunction are poorly understood. Given the heart's preference for fatty     acids (FA) as an energy source, a deeper understanding of FA metabolism may shed light on RV     adaptation to elevated afterload in PAH. The purpose of this study is to test the hypothesis     that defects in fatty acid metabolism are common in PAH and contribute to RV failure. The     investigators will measure peripheral and transcardiac lipid and glucose metabolites in PAH     patients in comparison with patients with pulmonary venous hypertension and no evidence of     pulmonary hypertension. The investigators will also correlate metabolites with concurrent     measurement of right ventricular function.   "
49978|NCT02631408|"     Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in     spinal fusion surgery. The powder will be locally administered into to the wound cavity     before wound closure.      Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical     site infections   "
49979|NCT02631395|"     Very little is known about the potential for preventing the prevalence of shoulder complaints     in handball players, particularly younger players. The aim of this study is to evaluate the     effect of a shoulder training program on shoulder pain during a season of team handball.   "
49980|NCT02631382|"     Randomized clinical trial to compare the effectiveness and safety of double (traditional)     versus single (Asian) cupping techniques in chronic low back pain.   "
49981|NCT02631369|"     Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by     Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of     the influence of measuring with or without eye tracker.      Study: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in     healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg     Spectralis   "
49982|NCT02631356|"     The study is to investigate the effect of succinylated gelatin on the blood viscosity and     oxygen delivery in patients during surgeries, so as to have a better understanding of the     safety in the use of succinylated gelatin for surgical patients.   "
49983|NCT02631343|"     While newborn and child survival remains a priority, optimal development of survivors is     receiving increasing attention. Interventions that impact both survival and development     should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and     potentially neurodevelopment, in preterm and low birth weight infants in hospital settings     but its coverage remains low. Innovation is required to allow the community-based delivery of     KMC by front-line workers. This could greatly accelerate scale up and sustainability of this     intervention in low resource settings.      The proposed randomized trial is planned in a setting where 40% of births take place at home.     Early discharge (as early as within 12 hours of birth) is common for facility births, often     at the request of families for social and cultural reasons. Many of the hospitals do not have     incubators for the care of very small babies.   "
49984|NCT02631330|"     Practice guidelines in caring for the geriatric population recommend performing an annual     screening of falls . However, one of the problems that interfere with fall prevention     programs is the lack of importance accorded to health professionals to falls. This lack of     awareness of the risks faced by the associated geriatric population falls generates     reluctance to adherence to a fall prevention program . At European level there are the same     gaps in knowledge about the real effectiveness and efficiency of fall prevention programs .      HYPOTHESIS: The implementation of a multicomponent fall prevention program in frail and     pre-frail elderly community-dwelling people reduce the incidence of falls.      OBJECTIVES      General:      • To determine the efficacy of a comprehensive program to prevent falls in the community.      Specific:        -  Knowing whether reducing the incidence of falls implies a reduction in visits to primary          care, emergency department or hospital staying.        -  Knowing the adhesion, through indirect measures, to the intervention program.        -  Knowing the nutritional, functional, cognitive, social, anthropometric, respiratory and          clinical profile, including falls, of the sample.      MATERIAL AND METHODS      Study design:      Multicenter community intervention study, longitudinal, prospective, randomized, and     experimental.      Through intervention by nurses in primary care education of subjects over 70 years it is to     know the effectiveness of a comprehensive program of falls prevention.      It will proceed to recruit older than or equal to 70 years subjects, who meet frailty     criteria age, belonging to the areas of Madeira Island (Portugal) and La Ribera County     (Valéncia, Spain) .   "
49996|NCT02631161|"     A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin     based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious     cervical lesions.   "
50024|NCT02630797|"     This study uses a bone labeled calcium tracer methodology to compare the dose response effect     of blueberry consumption on calcium retention and bone loss. Post menopausal women will     receive food or beverage products containing freeze dried blueberries over a 50 day period     equivalent to low (0.75 cups), medium (1.5 cups), and high (3 cups) of fresh berries. The     hypothesis is that the polyphenolic content of higher doses of blueberries will reduce     calcium loss from bones.   "
54353|NCT02574156|"     The investigators aim to study the impact of a strategy of a intensive glycemic control in     patients undergoing cardiac surgery.   "
49985|NCT02631317|"     PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on     hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS). With     a proposed Reengineered Process Framework for intravenous thrombolysis process by the     PROMISE study steering committee, about 30 medical centers enters would be recruited     nationwide, and each center would include consecutive AIS patients with an onset-to-door time     (ODT) of less than 3.5 h. The investigators hypothesize that the proposed Reengineered     Process Framework is suitable and feasible for hospitals in mainland of China; the rate of     intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h     would be more than 20% or be increased by 40% as compared with baseline; the proportion of     patients with a door-to-needle (DNT) time of less than 60 min would be more than 20%, or be     with an increase by ≥ 40% as compared with baseline.   "
49986|NCT02631304|"     The purpose of this study is to assess the association between the point-of-care (POC)     measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and     postoperative delirium in elderly patients undergoing cardiac surgery.      Furthermore the investigators aim to identify factors, which influence the baseline levels     and the time course of ChE activity.   "
49987|NCT02631291|"     This study is for adults 60 years and older who are grieving the recent loss of a spouse or     partner. Bereavement is one of the most distressing transitions faced by older adults and     triggers dramatic changes to older adults' daily routine which puts them at-risk for a mood     disorder. The purpose of this study is to promote bereaved elders' mental health by focusing     on healthy lifestyle practices. Study treatment involves using a tablet to record their daily     physical activity, diet, and sleep behaviors, for 12 weeks. The investigators follow-up with     people for up to one year.   "
49988|NCT02631278|"     The aim of this study is to investigate the safety and feasibility of a radiofrequency (RF)     system employing RFITT (CelonProSurge) probes for the ablative treatment of uterine fibroids.   "
49989|NCT02631265|"     It has been reported that insulin basal rate reduction initiated at exercise onset can reduce     the hypoglycemic risk during exercise. However, another potentially more efficient strategy     to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time     prior to exercise. No study investigated what would be the best timing to initiate such     temporary basal insulin reduction. Therefore, the objective of this study will be to compare     the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min     exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of     exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal     rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in     hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise     compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in     hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise     compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less     when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction     20 minutes prior to exercise.   "
49990|NCT02631252|"     This is an open label phase I clinical trial of hydroxychloroquine (HCQ) ,when it is combined     with the usual medications for acute myeloid leukemia, mitoxantrone and etoposide. The     purpose of this study is to find the safest and most effective dose of hydroxychloroquine     with these medications. The investigators will be testing to see if it can increase the     effectiveness of mitoxantrone and etoposide.   "
49991|NCT02631239|"     Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and     heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%.     The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western     countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for     these patients. But the optimal treatment schedule is controversial. The previous protocols     usually contained high dose methotrexate, but the application of them is limited for the     toxicity.   "
49992|NCT02631226|"     The purpose of this study is to determine the prevalence and risk factors for multi-resistant     enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital     and its transmission to the newborn, in order to avoid neonatal intensive care unit spread     and nosocomial outbreaks.   "
49993|NCT02631200|"     This study will test the feasibility of carrying out a randomised controlled trial,     incorporating a mixed methods process evaluation, to evaluate advance care planning with     older patients who have end-stage kidney disease.   "
49994|NCT02631187|"     This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK)     multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3)     retraction pockets (RPs). This future study will aim to address the question: Does BET     improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in     adult patients?      Currently conservative treatments for this condition has been shown to be ineffective; there     is a significant risk of progression to hearing loss or more serious complications in     untreated retraction pockets; and the surgical treatments available to us in the UK not only     have a number of risks and drawbacks, but also do not aim to treat the underlying cause     (Eustachian Tube dysfunction (ETD)).   "
49995|NCT02631174|"     The potential role of ATIII in achieving and maintaining adequate anticoagulation in     pediatric patients on the heart-lung machine has recently taken on increased importance as     caregivers strive to mitigate the risk for clinically significant clotting problems. It is     known that ATIII levels are decreased in normal neonates and infants less than 6 months of     age relative to older children and adults and become even further decreased in critically ill     neonates and infants, including those with congenital heart disease. The current utilization     of ATIII in the context of support on a heart-lung machine is based on pharmacokinetic data     derived from adult subjects with congenital ATIII deficiency. There is a gap in knowledge as     to the appropriate frequency of ATIII repletion, best method of monitoring, and mode of     administration in critically ill neonates and infants receiving support on a heart-lung     machine.Our long-term goal is to determine if antithrombin (ATIII) can effectively change the     coagulation system in patients undergoing heart-lung machine support. The objective of this     proposal, which is our first step in pursuit of that goal, is to determine the     pharmacokinetics of ATIII in neonates and infants. Our central hypothesis is that ATIII will     have different pharmacokinetic properties in neonates and infants than adults and these     properties will be affected by the use of heart-lung machine.      This research will result in critical data on the pharmacokinetics of ATIII in neonates and     infants receiving heart-lung machine support. This contribution is significant because it is     the first step in a continuum of research that is expected to lead to the development of a     therapeutic strategy employing ATIII that will facilitate improved modulation of the     coagulation cascade to prevent significant clotting and bleeding complications in pediatric     patients requiring heart-lung machine support.   "
54957|NCT02566291|"     In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain     are investigated.   "
49997|NCT02631148|"     In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to     extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly     controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether     sleep extension and nightly melatonin supplementation in the community is a feasible     intervention with a beneficial effect on the following chronic kidney disease (CKD) risk     factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation     (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone     excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by     24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave     analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance     and β-cell response to a mixed meal protocol.   "
49998|NCT02631135|"     It is important to wake up without any problem and comfortably from the general anesthesia.     The aim of this study is to investigate the effects of addition dexmedetomidine to the     balanced intravenous anesthesia with propofol over the cognitive functions and also it is     considered that the addition of dexmedetomidine would reduce the use of anesthetics drugs in     TİVA. Together with this effects, it has been considered that the disorder of the cognitive     functions in postoperative period and the need for anesthetic drugs in postoperative period     will be less.      After the approval of the Ethics Committee and the patients being informed and taking     informed consent from them 15 male 25 female totally 40 patients between the age of 20-60     years old, who had lumbar disc hernia, under general anesthesia have been taken under the     study. The patients have been divided into two groups by closed envelope drawing method,     randomly. All patients cognitive functions were evaluated by MMSE (Mini Mental State     Examination) during the premedication visit. For this study group Standardized Mini Mental     Test Examination (SMMT-E) were used, which has quite practical usage, for the untrained     patients, and test composed of question-answer in order to calculate the remembering, caution     and calculation structure and the scores were recorded. All patients had received the same     anesthesia induction with propofol infusion (started at firstly 12 mg. kg-1 for the 30     minutes, the second 30 minutes 9 mg. kg-1 and the BIS(bispectral index) values were arranged     between 40-60 until the end of the operation), and remifentanil infusion (0.5 μg.kg-1 was     applied as opioid and was arranged according to the tension artery and heart rate). In the     dexmedetomidine group, dexmedetomidine infusion had started as 0.5 μg.kg-1 without making the     loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for     the endotracheal intubation. After the operation all patients have taken to the recovery     room.      Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24     hours, 1 week and 1 month.   "
49999|NCT02631122|"     The aim of this study is to evaluate differences between ultrasound guided supraclavicular     versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block     techniques that differ in their needle trajectory and injection site.   "
50000|NCT02631109|"     This study aimed to investigate the efficacy and safety of Pegaspargase together with     liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as a salvage     therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.   "
50001|NCT02631096|"     The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the     safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of     intravenous ARB-001467   "
50002|NCT02631083|"     The study is carried out to find out the inclusion of high and low glycaemic index foods to     daily meals and how they impact 24 hour blood glucose fluctuations and energy regulation.   "
50003|NCT02631070|"     The study will be conducted in compliance with the International Council on Harmonisation     (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good     Clinical Practice (GCP) and applicable regulatory requirements.      This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to     determine the efficacy and safety of luspatercept (ACE-536) versus placebo in subjects with     anemia due to IPSS-R very low, low, or intermediate MDS with ring sideroblasts who require     RBC transfusions.   "
50004|NCT02631057|"     The primary objective of this study is to compare the LoS from treatment of oral     anticoagulant initiation to hospital discharge of patients hospitalized and subsequently     treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world     Japanese clinical practice. The secondary objective of the study is to compare LoS of     patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial     fibrillation. Other objectives are (1) to compare the in-hospital direct and indirect-related     costs between dabigatran and warfarin, and (2) to compare the rates of patients directly     discharged at home after the index hospitalization between dabigatran and warfarin.   "
50005|NCT02631044|"     This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of     modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell     NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety     and antitumor activity. We will also determine how long the modified T cells stay in the     patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma     whose disease has come back or has not responded to treatment.   "
50006|NCT02631031|"     The choice of drug administration time may affect the pharmacokinetics and/or drug response,     and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects     or to enhance efficacy. This study designed to investigate the potential influence of the     time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in     healthy subjects.   "
50007|NCT02631018|"     The purpose of this study is to compare the effect of a physical activity-enhanced behavioral     weight loss intervention, compared to a standard behavioral weight loss intervention in     African American women.   "
50008|NCT02631005|"     The purpose of this study is to evaluate the effects of Walk With Ease, a     moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus.     Participants will receive a copy of the Walk With Ease workbook. The book provides guidance     about walking safety as well as how to start, build-up, and maintain a walking program.     Participants will complete questionnaires assessing their symptoms before and after     completing the six-week program.   "
50009|NCT02630992|"     To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced     concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered     at 90/3.2 mg/kg/day in two divided doses for 10 days. Investigators will focus on the     proportion of subjects who develop protocol-defined diarrhea and proportion who develop     diaper dermatitis that occasions the prescription of antifungal medication.   "
50010|NCT02630979|"     The study measures the degree of oncology physician satisfaction with the outcomes of some     cytotoxic agents.   "
50011|NCT02630966|"     The purpose of this study is to evaluate perianal fistula healing at Week 30 in 2 different     dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with     fistulizing Crohn's disease (CD).   "
50012|NCT02630953|"     The overall goals of this renewal are to replicate the findings of Seamos Saludables in     Latina women, increase the effectiveness of the intervention, and measure     intervention-related changes in clinical biomarkers. We will enhance the existing     intervention by incorporating participant feedback (desire for greater interactivity and     accountability), further targeting Social Cognitive Theory (SCT) constructs that were not     influenced overall by the original intervention yet improved amongst our most successful     participants (social support, outcome expectancies), and responding to changing trends and     technology use in Latinos. We will conduct a clinical trial among Latina women in California     randomized to either 1) the original Seamos Saludables tailored print only intervention or 2)     a theory and text messaging-enhanced interactive technology based version of the Seamos     Saludables intervention. We will also measure changes in cardiovascular and metabolic     biomarkers (e.g., HbA1c, and LDL) to assess potential clinical impact of the intervention.   "
50013|NCT02630940|"     Analysis of exhaled breath condensate biomarkers and cough severity in patients with     idiopathic pulmonary fibrosis.   "
50014|NCT02630927|"     The purpose of the study is to investigate a drug called AG-519, which is being developed for     the treatment of a disease called pyruvate kinase deficiency (also known as PK deficiency)     and other forms of anemia. This study is a 5 part study with Part 1 enrolling healthy     volunteers into single ascending dose (SAD) groups, Part 2 enrolling healthy volunteers into     multiple ascending dose (MAD) groups and Part 3 enrolling healthy volunteers to investigate     how much of the study drug is taken up by the body and how food affects the uptake of a     prototype formulation of AG-519, Part 4 enrolling healthy volunteers of Japanese origin to     compare to the results of subjects of non-Japanese origin, and Part 5 a non-randomized,     open-label, multiple dose study enrolling healthy volunteers to further investigate how much     of the study drug is taken up by the body when dosed over 14 days.   "
50015|NCT02630914|"     The objective of the study is to investigate the feasibility of a hybrid procedure removal of     the atrial fibrillation.      This is a single procedure for both surgical epicardial by minimally invasive route     (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal     intracavitary route at the same time.      This faster procedure combined with complete lesions have a higher success rate and less     frequent re-hospitalizations of patients.   "
50016|NCT02630901|"     This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and     immunogenicity of PRX003 in approximately 56 patients with Psoriasis.   "
50017|NCT02630888|"     The main goal of this study is evaluate the efficacy of memantine association on the     treatment with a previous combination of two drugs, including quetiapine with lithium or     quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or     partial responders to that combination of drugs and evaluate the impact of this association     at the cognitive functioning of the patients.   "
50018|NCT02630875|"     This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients     with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus   "
50019|NCT02630862|"     The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy for     the secondary prevention of cerebral embolism in patients with carotid atherosclerosis.      Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including     vasodilation and antioxidant properties.      A role for oxidative stress has been suggested in acute cerebrovascular disease. In this     study the investigators want to test the in vivo antioxidant activity of dipyridamole in     patients who are candidate to take the drug under approved conditions of the Italian Drug     Regulation Agency, i.e. secondary prevention of TIA/Stroke in patinets with carotid stenosis     (>= 70%).      To test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products of     cholesterol autoxidation) and vitamin E are measured in plasma before and after 6 months     therapy after carotid endoarterectomy. Since dipyridamole is approved as combination     preparation with aspirin, a control group of patients taking aspirin alone is enrolled.      Outcome measures: plasma biomarkers (oxysterols and vitamin E) change at two time points:     baseline and 6-months therapy.   "
50020|NCT02630849|"     Chronic post-thoracotomy pain is a significant adverse outcome of thoracic surgery.     transcollation technology evaluated with a prospective randomized trial the effect of a     multimodal no-compression suture technique of the intercostal space on postoperative pain     occurrence in patients undergoing mini-thoracotomy.      Patients undergoing a muscle-sparing lateral mini-thoracotomy for different thoracic diseases     were randomly divided into two groups:one group received intercostal muscle flap harvesting     and pericostal no-compression edge suture (IMF group), and the second group received a     standard suture technique associated with an intrapleural intercostal nerve block (IINB     group).      The aim of the study was to demonstrate that the multimodal no-compression suture technique     is a rapid and feasible procedure reducing early and chronic post‐thoracotomy pain intensity.   "
50021|NCT02630836|"     Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot     study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the     two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month     with the primary objective of safety. Secondary objectives are efficacy through axial     tomography and xRay, clinical efficacy and quality of life questionnaire.   "
50022|NCT02630823|"     Due to the high expression of PD-L1 in endometrial cancers as well as in ovarian cancers     which are molecularly similar to uterine serous cancers, using pembrolizumab should be     beneficial in this patient population. Since the investigators are able to get a     pre-treatment research- related endometrial biopsy as well as the surgical specimen post two     cycles of pembrolizumab, the investigators will be able to evaluate the mechanism of action     of this drug on the endometrial cancer tumor environment.   "
50023|NCT02630810|"     This study evaluates the effect of early oral hydration on bowel movement after CS, it     includes 2 groups: study group participants receive 100 ml water after 1hr from the end of     CS, while the others receive water after 6hrs from the end of CS.   "
50312|NCT02627040|"     The main goal of the study is to determine which cephalomedullary nail results in a better     functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects     will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan     cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.   "
50025|NCT02630784|"     VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two     mechanical ventilators during non-invasive ventilation for patient suffering from respiratory     acidosis.      This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning     with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated     ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation     valve.      Patient will be randomized before the first NIV session lasting 2 hours. After a two hours     wash-out, a second NIV treatment will be delivered with the other ventilator for duration of     2 hours.      Arterial blood samples will be collected at the beginning and the end of each session of NIV.     A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient     monitoring.   "
50026|NCT02630771|"     This proposal will investigate pain modulatory mechanisms and brain functional and structural     characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder     (PDAP) patients with and without temporomandibular disorders (TMD). All measures from     patients will be compared to painfree controls.   "
50027|NCT02630758|"     The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga     intervention on depressive symptoms and rumination among depressed women.   "
50028|NCT02630745|"     The aim of the study is to conduct a prospective randomized clinical trial to evaluate the     effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic     treatment on periodontal healing of the concurrent endodontic -periodontal lesion with     communication.   "
50029|NCT02630732|"     The primary scientific objective of the study entails examining whether perioperative pain     neuroscience education (PPNE or 'brain school') is more effective than classical back school     in reducing pain and improving pain inhibition in patients undergoing surgery for spinal     radiculopathy. A secondary objective implies examining whether PPNE is more effective than     classical back school in imparting a behavioural change (i.e. decreasing postoperative     healthcare expenditure for lumbar radiculopathy), improving functioning in daily life and     improving surgical experience (=better prepared for surgery, surgery meeting their     expectations) in patients undergoing surgery for spinal radiculopathy.   "
50030|NCT02630719|"     The goal of this study is to determine whether timolol eye drops are effective in alleviating     acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or     placebo (tears) to use as a migraine abortive medication.   "
50031|NCT02630706|"     This is a study is to evaluate the efficacy and safety of the addition of ertugliflozin to     metformin monotherapy in Asian participants with Type 2 diabetes mellitis (T2DM) who have     inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the mean     reduction from baseline in hemoglobin A1C (HbA1C) for both 15 mg and 5 mg ertugliflozin is     greater than for placebo.   "
50032|NCT02630693|"     The purpose of this study is to determine if the combination of endocrine therapy and     Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer     dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28     day cycle in combination with endocrine therapy.   "
50033|NCT02630680|"     The purpose of the study is to assess Eziclen/Izinova drug utilisation in the real life     setting in a representative sample of the European target population.   "
50034|NCT02630667|"     The aim of this study is to investigate the acute effects of ingestion of carbohydrates -     with different glycemic profiles - on cognitive function among preadolescent children (i.e.,     9-10 years).   "
50035|NCT02630654|"     This exploratory study aims to evaluate the diagnostic, prognostic and response predictive     value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine     Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed     methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an     interesting approach to solve this question (Lundberg et al 2011).   "
50036|NCT02630641|"     The general hypothesis put forward in this study is that the degree of cohesion (agreement)     in the relationship, or dyadic adjustment affects a patient's quality of life and clinical     course during the first few critical months following diagnosis and the introduction of     treatment. The level of cohesion in the relationship is certainly not the only parameter     associated with changes in the quality of life. Other factors must also be investigated such     as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse),     management (single therapy or adjuvant therapy), the level of physical activity, the     patient's age and the presence of functional disorders, etc.   "
50037|NCT02630628|"     Prospective, randomized, parallel-group controlled, open-label, international (Asian)     multicenter, comparison of corticosteroids combined with TAC and corticosteroids combined     with MMF.   "
50038|NCT02630615|"     The primary objective of this study is to establish circulating tumor cell (CTC) derived     xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair     mutations detected in CTC samples (personalize DNA repair therapy).   "
50039|NCT02630602|"     The purpose this study was to evaluate the therapeutic effect of a functional goat cheese on     obese and overweight people with altered lipid profile. The functional goat cheese containing     polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to benefit     cardiovascular health of people who need to normalize lipid profile; which in the long term     can contribute to the prevention of cardiovascular diseases.   "
50047|NCT02630498|"     This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder     surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The first     group will include those who receive a single shot brachial plexus (interscalene,     supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The     second group will be the control group and include those patients who receive general     anesthesia only, without any block whether due to the preference of patient or the surgeon   "
50048|NCT02630485|"     The purpose of this study is to help women with PCOS to improve their symptoms and ovulation     rate through a lifestyle intervention program which introduces a specific diet, a physical     activity regimen and mindfulness exercises to improve psychological well-being and overall     health.   "
50313|NCT02627027|"     This study is a randomized, open-label, single dose, 2-way crossover study to compare the     pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.   "
50040|NCT02630589|"     Tinnitus is the perception of sound or noise in the absence of an external physical source.     It is a highly prevalent condition and for a high percentage of patients, there is no     satisfying treatment modality. For some people, tinnitus has a very severe impact on quality     of life, leading to incapacity for work and sometimes even suicidality. The auditory     brainstem implant (ABI) is an implant indicated for the restoration of hearing in patients     with an hypo-, or aplasia of the cochlear nerve or with dysfunction of the nerve caused by     tumor growth in neurofibromatosis type II. It has been shown that the standard intended     effect of an ABI has reduction of tinnitus as a welcome side effect in about 66% of the     cases. This is in analogy with the promising effect of a cochlear implant (CI) as a treatment     for patients with unilateral tinnitus. In this study, the effect of an ABI on severely     invalidating, unilateral, intractable tinnitus will be investigated. The ABI may have an     advantage over the CI as tinnitus treatment, because CI-implantation leads to destruction of     inner ear structures, leading to profound deafness, while an ABI is presumed to not damage     anatomical structures. This is the first study to implant an ABI for the primary aim of     tinnitus reduction in an intervention pilot study. In total 10 patients with unilateral,     intractable tinnitus and severe hearing loss in the ipsilateral ear, will be implanted with     the ABI.   "
50041|NCT02630576|"     TetraGraph is a newly developed EMG-based (electromyograph), quantitative, battery-powered     neuromuscular monitoring system intended for daily clinical use. The primary aim of this     clinical investigation is to examine the applicability (ease of use, equipment need, etc.),     repeatability (precision or internal consistency) and performance (signal quality, accuracy     of outcome, voltage of stimulation output before and during a stimulus) and tolerability of     the Tetragraph device in healthy volunteers.   "
50042|NCT02630563|"     The study is planned to be conducted in 2 parts. The first part (open label, multi-center,     non-controlled) of the study will estimate a dose that would provide a mycophenolic acid     (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver     transplant participants receiving the approved dose of mycophenolate mofetil (MMF, CellCept).     The second part (open-label, multi-center, single-arm Phase IV study) of the study will     provide the pharmacokinetics, efficacy and safety profile of the proposed dose in the     immediate post-transplant period. This study will be conducted at two centers based in the     United States of America. Twelve pediatric transplant participants receiving a first liver     allograft from a cadaveric or living donor will be enrolled in this study. Stable pediatric     liver transplant participants who are at least 6 months post-transplant and who were already     receiving stable dose of MMF in combination with cyclosporine will be enrolled into the     study. Participants should have received stable MMF dose according to center practice for at     least seven days in order to get steady state pharmacokinetics (PK). Participants also should     have received stable concomitant doses of cyclosporine (for at least 2 days) and     corticosteroids per center practice. Participants will be aged between 9 months and 12 years,     with at least 6 participants greater than or equal to (>/=) 9 months and less than (<) 36     months, of whom at least 2 will be <24 months.   "
50043|NCT02630550|"     The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various     clinical contexts but not during the occlusion of major arteries, as takes place in vascular     surgery. The present study will evaluate the precision and validity of the measures taken by     the device during open vascular surgery procedures. The measurements will be compared to the     those calculated by transesophageal echocardiography at various key points during the     surgeries. The validity of the cardiac output, stroke volume and stroke volume variation     measurements will be evaluated, as well as the device's ability to track rapid changes in     cardiac output.   "
50044|NCT02630537|"     Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection     of transplanted organs. Thus, in transplant recipients a life-long and individualized     immunosuppressive medication is required to avoid graft rejection. However, a too weak     suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas     a too potent suppression of CMI supports opportunistic infections and reactivation of     persistent viruses.      One of the biggest challenges in the field of transplantation is to provide a personalized     immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI.     This could lead to a reduction of graft rejections and virus reactivations in transplant     recipients.      With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH     has implemented its novel proprietary T-activation technology for an improved assessment of     the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus     (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open     up the opportunity to characterize the functionality of CMI as an entire network.      The planned clinical multicenter study aims to verify the suitability of the two assays for a     reliable assessment of the functionality of CMI.      Hemodialysis patients have been identified as an appropriate patient cohort for investigating     the clinical sensitivity of the Lophius assays as these patients closely resemble kidney     transplant recipients prior to an immunosuppressive therapy.      The determination of the functional CMI in the course of an immunosuppressive treatment may     in future enable physicians to optimize the individual immunosuppressive and antiviral     therapy in transplant recipients to reduce the risk of rejection as well as virus     reactivations and associated diseases.   "
50045|NCT02630524|"     The purpose of this study is to examine the effectiveness of a low carbohydrate diet on     increasing dietary adherence and improving cardiometabolic risk factors among adults with     spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one     of two groups: 1) a reduced carbohydrate diet or 2): a standard diet (STD). Participants     will take part in a 6-month behavioral lifestyle intervention implemented through a novel     eHealth platform specially designed for individuals with SCI.   "
50046|NCT02630511|"     Although asthma is a disease of the airways, research is now showing that asthmatics are more     likely to develop cardiovascular disease (CVD) compared to non-asthmatics. Vascular     dysfunction is seen in people at high risk of CVD and has been linked to inflammation. During     an asthma attack, levels of inflammation in the whole body increase, which could potentially     explain why asthmatics are at increased risk of CVD. By exercising, people can change the     amount of inflammation in their bodies, improve vascular function, and thereby reduce the     risk of CVD. In the proposed study the investigators will assess if asthma attacks lead to     increased risk of CVD by evaluating inflammatory levels and vascular function before and     after asthma attacks. The investigators will also evaluate if exercise reduces the     cardiovascular risk following asthma attacks. The results from this study will help in     understanding why asthmatics are at increased risk of CVD.   "
50215|NCT02628301|"     This study aims to elucidate the role of the microcirculation in the development of whole     body insulin resistance. The investigators hypothesize that impaired insulin signaling in the     vasculature is an early phenomenon in the development of whole body insulin resistance.     Furthermore, the investigators aim to identify improvement of microvascular function as a     potential target in diabetes prevention and treatment.   "
50049|NCT02630472|"     The purpose of the study is to evaluate the physiologic response of quinine-saline     irrigations for acute exacerbation of uncomplicated chronic rhinosinusitis following     endoscopic sinus surgery. Subjects who have previously had functional endoscopic sinus     surgery with acute exacerbation of chronic rhinosinusitis will be randomized to either a     quinine-saline or saline-placebo arm. The investigators will measure baseline and follow-up     clinical and quality-of-life outcomes for both arms, and then compare the groups at the end     of the study period. The investigators' hypothesis is that the participants in the quinine     sulfate arm will perform better on all measures as compared to the control arm.   "
50050|NCT02630459|"     Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by     an open-label treatment phase. To evaluate the effect of AMG 334 compared to placebo on the     change from baseline in monthly migraine days.   "
50051|NCT02630446|"     The general objective of this quasi-experimental study is to assess the effectiveness of an     in-home respite care program compared to a control group not receiving the same type of     in-home respite on the well-being of the caregiver, the care-recipient and on the healthcare     system. The latter in terms of resource use, intention to institutionalize the care-recipient     and time to nursing home placement.      A quasi-experimental study will be designed. The intervention group will consist of     caregiver/care-recipient dyads receiving an in-home respite program called Baluchonnage and     will be compared to a control group that doesn't receive Baluchonnage. Comparison between     the groups will be done by collecting health related and economic data. The trial will     evaluate outcomes as well in the caregiver as in the care recipient (measured via the     caregiver). The primary research outcome is caregiver burden. Secondary outcomes for     caregivers are: health related quality of life and reactions to behavioral problems of the     care-recipient. A secondary outcome related to the care-recipient is: frequency of behavioral     problems. Secondary outcomes for the healthcare system are: intention to institutionalize the     recipient into a nursing home and resource use of the recipient. Finally, in a follow up     phase of the trial possible differences in time to nursing home placement will be measured     (as well as burden and intention to institutionalize. Additionally, willingness to pay for     Baluchonnage per day will be asked to the informal caregivers. Eventually, if the     intervention is effective, modeled and trial based cost-effectiveness analyses will be     undertaken in a separate economic evaluation plan.   "
50052|NCT02630433|"     There are controversies optimal timing for cholecystectomy in patients with mild biliary     pancreatitis. The safety of cholecystectomy performed during an episode of pancreatitis has     been questioned. The aim of the present randomized controlled trial is to compare the outcome     in terms of recurrent pancreatitis and gallstone-related events between index     cholecystectomy, performed during the first admission for acute pancreatitis, and scheduled     cholecystectomy, performed 4-6 weeks after discharge.   "
50053|NCT02630420|"     Two-part phase 1B clinical trial combining cextuximab and savolitinib for treating Ras     wild-type colorectal cancer (CRC). Part 1 will assess the safety and tolerability of this     drug combination and will include patients with squamous cell carcinoma of the head and neck     cancer, as well as patients with CRC. Part 2 of the study, the focus of this registration,     will obtain further safety data for the combination of cextuximab and savolitinib and will     look at the efficacy of cextuximab and savolitinib in Ras wild-type mCRC that was previously     treated and relapsed on cetuximab or panitumumab.Correlative studies will examine tumor and     blood specimens for mechanisms of anti-EGFR resistance and response to MET inhibition.   "
50054|NCT02630407|"     The possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the     post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers     and promoting a faster recovery after ACL reconstruction, seems attractive.      The aim of the present double blind, placebo controlled study is to evaluate the effects,     both in terms of pain control and functional recovery, provided by a single HA injection     performed in the early postoperative phase after ACL reconstruction.      The day after the ACL reconstruction (which is performed with the same technique for all the     patients enrolled), the patients were randomized to receive a single injection of HA or 3 ml     of saline solution. The randomization list was kept in a dedicated office and the injecting     physician contacted it to know the treatment allocation just before the injection, that was     performed by a lateral parapatellar approach, after removing the drainages and after     attempting aspiration to evacuate any eventual residual blood from the joint. In order to     maintain the patient blind to the treatment, a surgical drape was placed to prevent him to     see the injective procedure.      All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the     following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and     Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees     were registered at each follow-up evaluation.   "
50055|NCT02630394|"     Acute chest syndrome (ACS), a lung complication in sickle cell disease (SCD), is the second     most common cause of hospitalization and leading cause of death in SCD. ACS is associated     with airway inflammation, and a major cause is pulmonary infection from atypical organisms.     To date, there are no drugs available to reduce inflammation and risk of recurrent ACS.     Macrolides are a group of antibiotics that exert immunomodulatory and anti-inflammatory     actions both in vitro and in vivo. In addition, macrolides reduce bacterial burden in the     airway of atypical organisms, all of which play an important role in the pathophysiology of     ACS. Numerous studies have evaluated macrolide prophylaxis in conditions associated with lung     inflammation, such as cystic fibrosis, asthma, bronchiectasis etc., and high quality evidence     have found macrolides to be beneficial as a disease modifying agent that leads to improvement     in airway inflammation, reduced pulmonary exacerbations and improved lung function. The     investigators hypothesize that azithromycin prophylaxis is well tolerated and has the     potential to reduce inflammation and improve lung outcome in children with SCD with a history     of ACS. A prospective, single arm, open label feasibility study of azithromycin prophylaxis     will be performed in children with SCD with a history ACS with the specific aim to examine     the feasibility, safety and tolerability of azithromycin prophylaxis administration in     participants with SCD , and to examine whether azithromycin prophylaxis has the potential to     improve lung outcome. In addition, this study will determine whether azithromycin prophylaxis     reduces inflammation in participants with SCD with a history of ACS.   "
62888|NCT02462486|"     This is a safety and efficacy study of abicipar pegol in patients with neovascular     age-related macular degeneration.   "
50056|NCT02630381|"     Rationale: Osteoporotic fractures are associated with high morbidity and mortality. This is     why prevention of these fractures is important. The investigators have shown in animal     studies that a single treatment with unfocused extracorporeal shock wave therapy leads to     highly increased bone mass and improved biomechanical properties. Unfocused extracorporeal     shock wave therapy could have important implications for the prevention of osteoporotic     fractures.      Objective: To assess the effect of unfocused extracorporeal shock wave therapy on bone mass.      Study design: A clinical pilot study. Study population: Twelve female patients are eligible     if they are undergoing elective surgery of the lower extremity or elective spinal surgery     under general anesthesia in the investigators hospital.      Intervention: When the patient is under general anaesthesia he/she will receive 3000     unfocused extracorporeal shock waves (energy flux density 0.3mJ/mm2) to one distal forearm.     The contra lateral forearm will not be treated and serves as a control.      Main study parameters/endpoints:      The investigators will examine the effect on bone mass with the use of repeated dual energy     X-ray absorptiometry measurements. These results are necessary to calculate the number of     patients that are needed for larger studies. Furthermore, the investigators will assess     patient's discomfort.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: General anaesthesia is performed during treatment and pain after the procedure     will be evaluated using pain scales and, if necessary pain medication will be prescribed by     the orthopaedic surgeon. The dual energy X-ray absorptiometry-scans and X-rays will cause     very low radiation exposure to the patient.   "
50057|NCT02630368|"     Assessment of the efficacy and safety of JX-594 and metronomic cyclophosphamide in patients     with advanced soft-tissue sarcoma and advanced breast cancer, once the Maximum Tolerated Dose     have been determined (phase I trial).      Phase I study: this is a prospective open-labeled phase I trial based on a dose escalating     study design assessing two dose levels of JX594 when prescribed in combination with     metronomic cyclophosphamide.      Phase II study sarcoma: this is a monocentric, randomized two-arm non comparative phase 2     study assessing efficacy and safety of JX-594 in association with metronomic cyclophosphamide     in patients with advanced soft-tissue sarcoma.      Phase II study breast cancer: this is a monocentric, single-arm phase II study, assessing     efficacy and safety of JX-594 in association with metronomic cyclophosphamide in patients     with advanced breast cancer.   "
50058|NCT02630355|"     This study evaluates the use of remote ischaemic preconditioning for the prevention of     dialysis induced cardiac injury. The study uses four arms to test different frequencies of     application to ascertain which, if any, is most successful at reducing dialysis induced     cardiac injury.   "
50059|NCT02630342|"     Diagnostic Magnetic Resonance (MR) imaging procedures can be stressful for children and     parents. Patients must lie still during the procedure to provide diagnostic quality images.     Children <7 years are often sedated or given general anesthesia (GA) for imaging procedures.     The high cost of GA and its associated risks motivate the search for alternatives. The     overall goal of this study is to systematically investigate whether training on the mock MR     scanner reduces the need for GA during Magnetic Resonance Imaging (MRI) scans in children.      160 participants scheduled for diagnostic MRI scans at Alberta Children's Hospital (ACH) will     be recruited to undergo different training methods for MRI scanning. Group 1 will be sent     links to online videos about MRI, audio files with scanner noises, and a children's book     about MR scans, to prepare at home. Group 2 will receive training materials and visit the ACH     to review them with the research team, but will not use the mock scanner. Group 3 will     receive training materials and visit the ACH for training on the mock MR scanner. Visits to     the mock scanner for Group 3 will include practice lying down, staying still, wearing     headphones, and watching a movie on the mirror system. During and after training sessions,     the investigators will collect data on total time spent preparing (mock scanner or other),     the child's feelings of stress/worry before and after visit, and head motion during mock MRI     session (if applicable).      Subjects will be scheduled for a clinical scan without GA and a follow-up clinical scan with     GA (to be cancelled if the first scan is successful). Scan success will be determined by a     radiologist. Measures of scan success, quality ratings for each scan, children's feelings of     stress/worry related to the MRI, and saliva samples to measure cortisol and salivary alpha     amylase, will be gathered at the clinical scan. An ANOVA will be used to compare different     training groups.      A clinical group of 35 neuro-oncology patients aged 3-7 years of age that undergo frequent     MRI scans will also undergo staged preparation by child life specialists using the mock     scanner. The age at which they are able to complete MRI without general anesthesia will be     compared with a retrospective control group in the 3 years prior. Measures to be used for     this group are the same (with the exception of saliva samples). T test and Kaplan- Meier     analysis will be used to compare age at which MRI can be performed awake.   "
50060|NCT02630329|"     Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and     established laparoscopic removal of benign adnexal masses Study design: Randomized     controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.      Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal     masses detected by clinical examination and ultrasound.      Randomization: Women will be randomly allocated to undergo one of two techniques for removal     of the benign adnexal mass immediately before surgery by using a computer generated     randomization list. The investigators will use stratified randomization according to the cyst     diameter.      Intervention: Women will be treated by a surgeon who is not blinded to the treatment     allocation and who is equally skilled in performing both techniques. In the intervention     group a vNOTES technique will be used.      Control: In the control group surgery will be done by a classical laparoscopic technique.      Participants, nursing staff and outcome assessors will be blinded.      Main study parameters/endpoints:      Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary     outcomes: the proportion of women discharged the same day based on their own preference;     postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7     by the participating women following surgery and the total amount of analgesics used as     described in the standardized pain treatment protocol between day 1 till 7; postoperative     infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or     laboratory findings; per- or postoperative complications according to the Clavien- Dindo     classification detected during the first six weeks of surgery; duration of the surgical     procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6     months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing     recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale);     direct costs associated up to 6 weeks after the surgical intervention with both procedures.   "
50061|NCT02630316|"     This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded,     placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in     subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung     disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will     include about 314 patients at approximately 120 clinical trial centers. The treatment phase     of the study will last approximately 16 weeks. Patients who complete all required assessments     will also be eligible to enter an open-label, extension study (RIN-PH-202).   "
50062|NCT02630303|"     The goal of this study is to establish the safety of high fluence LED-RL from 160 J/cm2 up to     640 J/cm2 in healthy subjects. The hypothesis is that high fluence LED-RL phototherapy is     safe in human skin.   "
50216|NCT02628288|"     Comparison of healing responses after treatment of complex bifurcation lesions with a     dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System +     Absorb BVS in the distal branches) versus the Modified T stenting technique using Absorb BVS:     an optical coherence tomography (OCT) analysis.   "
50063|NCT02630290|"     Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent     influences on the filed of perineural block. It could shorten the onset time and prolong the     duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced     bradycardia or hypotension has recently attracted considerable attention because of     potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A     low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few     studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural     adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine     added to ropivacaine would safely enhance the duration of analgesia without adverse effects     when compared with ropivacaine alone. Investigators will conduct a single-center,     prospective, randomized, triple-blind, controlled trial in patients undergoing elective     forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using     either ropivacaine or ropivacaine plus low-dose dexmedetomidine. The primary outcome is     self-reported duration of analgesia . Secondary outcomes include onset time and duration of     motor and sensory block, total postoperative analgesics, and safety assessment (adverse     effects and postoperative abnormal sensation).   "
50064|NCT02630277|"     To assess the safety and efficacy of intravitreal aflibercept injection in the regression of     retinal neovascularization secondary to high-risk PDR.      To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in     patients with high-risk PDR   "
50065|NCT02630264|"     Recombinant human endostatin adenovirus injection is a novel anti-tumor gene therapy drug.     E10A contains a recombinant human endostatin gene with the second-generation recombinant     adenovirus as its vector. After transfection tumor cells. E10A expresses human endostatin,     which inhibits vascular endothelial cell proliferation and tumor angiogenesis, and blocks     tumor blood supply, thereby specifically inhibiting tumor growth and inducing apoposis of     tumor cells. Both pre-clinical and animal models have demonstrated the anti-tumor activities     of E10A. The safety and efficacy of E10A in treating head and neck cancer has also been     demonstrated in Phase I and Phase II studies.   "
50066|NCT02630251|"     The study drug, GSK2820151, is a Bromodomain (BRD) and Extra-Terminal (BET) inhibitor arising     from a distinct structural class. GSK2820151 potently inhibits tumor growth in vitro and in     vivo in animal models. This first time in human (FTIH), open-label, dose escalation study is     to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical     activity of GSK2820151 in subjects with advanced or recurrent solid tumors. The objective is     to determine the safety, tolerability and maximum tolerated dose (MTD) of GSK2820151 in     subjects 18 years or older with advanced or recurrent solid tumors. Eligible subjects with     advanced or recurrent solid tumors will be enrolled in the dosing cohorts until MTD is     established. All subjects will receive study drug. Subjects may continue treatment in the     study until disease progression, unacceptable toxicity, or withdrawal of consent. The     duration of study will depend on recruitment rates and the timing of subjects' duration on     study (withdrawal rates due to toxicity or progression). It is anticipated that approximately     30 to 50 subjects will be enrolled.   "
50067|NCT02630238|"     This double blind placebo study will take place over an 8 week treatment period of diet and     exercise. All participants (n=16), in two groups, will be placed on the same hypocaloric diet     and exercise program. Participants will be matched into pairs based on body fat % and then     assigned into a test group & a placebo group. The placebo will be in the form of a powdered     isoenergetic beverage with carbohydrate similar in taste & appearance to the powder BCAA     supplement that the test group will receive. The test group will be put on 0.342g/kg of BCAA     per day, partially accounted for through their diet with the rest provided by a BCAA     supplement. At baseline, 4 weeks and 8 weeks habitual 3 day food logs, waist to hip ratio and     BodPod measures of body fat & lean mass (both percentage & absolute values) will be taken for     all participants.   "
50068|NCT02630225|"     The investigators will conduct a cluster randomized trial of an intervention program that     combines a hospital-based intervention, structured outreach program, and multi-agency     attention. The goal of the study is to test the effect of this multi-component intervention     on criminal activity, injury, substance abuse, mental health, quality of life, violent     behavior, and death.      Investigators aim to enroll a total of 300 patients admitted to the Harborview Medical Center     (HMC) for firearm-related injuries. Patients will be randomized to receive a multi-component     intervention or treatment as usual. All participants will complete surveys at the time of     study consent (baseline) and then at designated time points for 12 months post-consent. Study     staff will routinely collect participant records from Washington State Patrol records, HMC     medical records, Washington State trauma registry, Washington State Emergency Department     Information Exchange, Administrative Office of the Courts, and vital records. The     investigators will test the impact of the intervention against standard care. The hypothesis     is that participants in the intervention group will see greater improvements in     aforementioned outcomes than those in the control group.   "
50069|NCT02630212|"     The purpose of this study is to evaluate the impact of ALDH2 Glu504Lys polymorphism on aortic     dissection.   "
50083|NCT02630030|"     This phase 0 trial studies ixazomib citrate in treating patients with glioblastoma that has     spread or returned after period of improvement who are planning to undergo surgery. When     given by mouth, ixazomib citrate may be able to reach tumor cells in the brain. Studying     samples of tissue, blood, and plasma in the laboratory from patients receiving ixazomib     citrate may help doctors learn more about the effects of ixazomib citrate on the cells. It     may also help doctors understand how well patients will respond to treatment.   "
50084|NCT02630017|"     To investigate the effects of methylphenidate on motivated behavior in adults with and     without ADHD   "
50085|NCT02630004|"     The main purpose of this study is to assess the efficacy of melatonin oral gel compared to     placebo in the prevention and treatment of oral mucositis in patients with head and neck     cancer undergoing concurrent chemoradiation.      Other objectives are to assess the Quality of Life (QoL), to evaluate the safety and     tolerability and to assess the pharmacokinetic profile of melatonin oral gel administration,     in all cases compared to placebo in patients with head and neck cancer and oral mucositis     secondary to concurrent chemoradiation.   "
50250|NCT02627846|"     A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation     (ClariVein®) in the management of superficial venous insufficiency.   "
50070|NCT02630199|"     This study is a single center open label phase I study of AZD6738, DNA damage repair/novel     cancer agent, in combination with paclitaxel in metastatic cancer patients who have failed     standard chemotherapy.      AZD6738 is an orally dosed selective and potent inhibitor of Ataxia Telangiectasis and Rad3     Related (ATR) kinase with good selectivity against other Pi3 kinase family members.      ATR is a serine/threonine protein kinase and member of the phosphatidylinositol 3-kinase     related kinase (PIKK) family. During normal replication, ATR is recruited at stalled     replication forks which can progress to double strand breaks if left unrepaired. ATR is also     recruited to single strand DNA coated with Replication Protein A (RPA) following single     strand DNA damage or the resection of double strand breaks. Recruitment and activation of ATR     leads to cell cycle arrest in the S phase while the DNA is repaired and the stalled     replication fork resolved, or nuclear fragmentation and entry into programmed cell death     (apoptosis).      In the clinic ATR inhibitors are expected to cause growth inhibition in tumour cells     dependent upon ATR for DNA repair e.g. ATM-deficient tumours. In addition to monotherapy     activity, ATR inhibitors are also predicted to potentiate the activity of cytotoxic DNA     damaging agents and radiotherapy (through inhibition of ATR-dependent DNA repair processes)     when used in combination. While significant enhancement of anti-tumour activity may be     achieved, data with AZD6738 suggest the potential need to reduce the ATR inhibitor dose and     intensity (relative to monotherapy dose) and introduce dosing breaks to allow normal tissue     recovery when used in combination with systemic DNA damaging chemotherapy agents, in order to     maintain tolerable therapeutic margins.      The mechanism of action of AZD6738 suggests the potential to combine it with a number of     anti-cancer treatments, resulting in either synergistic or additive activity. This study is     evaluating the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD6738 at     increasing doses, in combination with paclitaxel as one of standard salvage regimen in     patients with advanced cancer.      The study will consist of two parts, each evaluating the safety and tolerability of a     specific combination agent, paclitaxel with different drug schedules. An oral formulation of     AZD6738 will be used.      The PART A will be in combination with paclitaxel; the starting dose of 40 mg AZD6738 OD will     be escalated to reach a maximum tolerated dose in patients with advanced solid malignancies,     as defined by dose-limiting toxicity. The PART B will be an independent parallel PK expansion     cohort with cycle 0 of AZD6738 on D1, D8~D21 monotherapy followed by combination therapy with     weekly paclitaxel from cycle 1. Investigators will modify to recruit the minimum or maximum     number of patients depending on data generated from other studies using AZD6738.   "
50071|NCT02630186|"     This clinical research study is being carried out in two parts, Phase 1 and Phase 2. The     primary purpose of the Phase 1 portion of the study is to observe the safety of the     combination of rociletinib and MPDL3280A in EGFR-mutant NSCLC patients.      The primary purpose of the Phase 2 portion of the study is to evaluate the safety and     anti-tumor effects of the combination of rociletinib and MPDL3280A, at the best doses for the     combination determined in Phase 1, in patients with EGFR-mutant NSCLC.   "
50072|NCT02630173|"     Introduction:      To evaluate the effect of untreated endodontic infection on periodontal status in untreated     non vital teeth with periapical radiolucency as compared to contralateral vital teeth. And     also to evaluate the role of endodontic treatment on periodontal healing in successfully     endodontically treated teeth with contralateral vital teeth.      Methods:      This study was performed in two parts. First part of this study was an observational cross     sectional survey and second part was a clinical trial on patients selected from the survey.   "
50073|NCT02630160|"     A randomized double-blind clinical trial was performed. There were 4 groups according to     catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2)     Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial     catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous     perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus +     continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy     and the surgeon kept out the surgical field when the resident placed the catheter. The same     conventional analgesic schedule was prescribed to all patients: PCA (patient controlled     analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of     PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects,     time to start rehabilitation and time to discharge were also analyzed. A statistical analysis     was performed to compare all this variables between the 4 groups (SPSS 18.0).   "
50074|NCT02630147|"     The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent     events in premature infants born between 32.0 and 33.6 weeks of gestational age.   "
50075|NCT02630134|"     Study patients are given a hand held device to track pain post surgery.   "
50076|NCT02630121|"     The addition of intranasal oxymetazoline for two weeks to already instituted optimal doses of     intranasal fluticasone propionate will decrease the total number of obstructive apneas and     hypopneas per hour of sleep in subjects with perennial allergic or non-allergic rhinitis and     mild obstructive sleep apnea who have persistent nasal congestion despite maximum doses of     NGCS.   "
50077|NCT02630108|"     It is a prospective and multi-center clinical research in China to compare the efficacy,     safety and related impact factors between TACE alone and TACE combined with synchronous     multi-point MWA/RFA for large and huge liver cancer.   "
50078|NCT02630095|"     The purpose of this study is to determine the effect and safety of anticoagulation after     endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its     effect on long-term rebleeding rate and mortality.   "
50079|NCT02630082|"     Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV     entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated     abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at     high risk of HIV infection. The purpose of this study is to evaluate the feasibility of     methods for assessing baseline characteristics of the mucosa of MSM at risk of HIV infection     in Lima, Peru.   "
50080|NCT02630069|"     This study is a 12-week, randomized, double-blind, placebo-controlled trial of     cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.   "
50081|NCT02630056|"     The purpose of this study is to validate the dosimetric parameters that correlate with acute     hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant     chemoradiotherapy.   "
50082|NCT02630043|"     The purpose of this research study is to evaluate an investigational drug (Tolcapone) alone     and in combination with oxaliplatin, for relapsed and refractory neuroblastoma. Tolcapone is     approved by the U.S. Food and Drug Administration (FDA) for adults, but is an investigational     drug in this study because it has not been approved in pediatrics for this indication.     Oxaliplatin, although a drug approved by the FDA for other cancers, is investigational for     treatment of neuroblastoma in this study. This study will look at the safety and tolerability     of tolcapone in combination with oxaliplatin as well as the tumors response to this study     drug.   "
50104|NCT02629757|"     This study is being conducted to help determine whether β-elemene as maintain treatment for     complete remission patients of newly diagnosed malignant gliomas following standard     treatment, is able to delay tumor growth, or impact how long people with newly diagnosed     high-grade glioma.   "
63109|NCT02459600|"     Assessment of refraction measurements in children under general anesthesia, with or without     cyclopelgic eye-drops   "
50086|NCT02629991|"     The investigators propose a randomized double blind 8 week treatment trial of intranasal OXT     vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect (1)     Eating behaviors (2) Repetitive and disruptive behaviors (3) social cognition measures and     (4) Salivary OXT levels and plasma levels of ghrelin, pancreatic polypeptide and leptin. The     investigators will determine if IN-OXT reduces eating behaviors in addition to improving     social cognition and reducing repetitive/disruptive behaviors in children with PWS. If     superior to placebo, this data will add to the current knowledge that OXT is an effective     treatment for hyperphagia as well as other problematic symptomatology of PWS.   "
50087|NCT02629978|"     The objective of this study is to evaluate the outcomes of radiofrequency ablation in the     treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable     candidates for or refuse surgical resection.   "
50088|NCT02629965|"     This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial     to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol     FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung     hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6     weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.   "
50089|NCT02629952|"     Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries, show     great potential as nutraceuticals for the treatment of various diseases such as type 2     diabetes (T2D). Flavonoids have been suggested to improve glucose metabolism, reduce blood     lipids, reduce oxidative stress and improve vascular function. For these reasons we recently     investigated the effects of daily consumption of locally produced blueberry tea and     demonstrated that this could partially restore insulin sensitivity in an animal model. We     propose to translate these findings to assess the efficacy of this nutraceutical as a new     treatment for improving glucose tolerance in people with T2D.   "
50090|NCT02629939|"     Cardiac arrest is a public health problem and is the leading cause of death in many parts of     the world.      Cardiac arrest can occur inside the hospital and outside it. In the United States and Canada     occur in approximately 350,000 cases of cardiac arrest a year , who receive CPR , Half of     them outside the hospital.      Treatment of cardiac arrest is performing Cardio Pulmonary Resuscitation (CPR) and early     defibrillation.      Performing compressions is the essential part of performing CPR until the arrival of     defibrillation.      Efforts are being made to simplify the implementation of basic CPR and make it accessible to     everyone. Method hands only CPR offers CPR with compressions only without ventilations,     Studies have shown a similar survival rate between hands only CPR method and CPR with     ventilations.      Patient's chances of survival are higher if a bystander begins performing CPR until trained     medical staff arrives.      Chances of survival decreases by 7-10% every passing minute past moment of collapse if not     performed CPR.      MDA survey carried out in 1984-5 reported at the start of CPR by a bystander at 8% Another     survey in 2000 reported 14%, In a recent study in Jerusalem found a rate of only 15% of     performing compressions by bystanders- A very low rate compared to 33% reported in the United     States 41.3% in Japan and 44.9% in Denmark.      The average time of arrival of the medical team in Israel is 10.3 minutes, so it is very     important to begin performing CPR by those present before the arrival of medical staff.      Most cases of cardiac arrest were the result of a previous cardiac disease, Therefore     patients with cardiac disease are at higher risk of cardiac arrest and cardiac death.      Place cardiac arrest is 72% percent of the time at home, and the likely presence of family     members.      The general population should know basic resuscitation to save a life, knowledge is needed     especially among families of heart patients who are way more likely that such an event will     occur in their presence.      Therefore, one can relate to families of heart patients dedicated to increasing population as     a basic knowledge of CPR.      There is no other organized plan to study family members of patients with heart disease basic     knowledge of CPR Despite the importance of it Attempts have been published in previous     studies from around the world to create a focus group study of CPR among close relatives of     heart patients. An attempt was made to incorporate as part of the proposed cardiac     rehabilitation patients after MI Through self-study kit given at discharge from the hospital     and more Difficult to evaluate the success of these efforts over the long term, but     short-term study of short workshops yielded sufficient knowledge about basic CPR This study     should serve as a catalyst as a first step towards building a suitable program nationwide and     hopefully save many lives   "
50091|NCT02629926|"     Cure rates for childhood malignancies have improved at a remarkable pace.With the increasing     cure rate came recognition of the long-term detrimental effects of radiotherapy and     chemotherapy, known as late-effects. Endocrine late-effects are particularly prevalent in     childhood cancer survivors. Growth Hormone (GH) deficiency is common following radiation to     the head and leads to impaired growth, hence GH replacement is given to achieve optimise     final height in childhood. In the adult GH is important to maintenance of bone, muscle & fat     mass; vascular risk factors; and quality of life. This observational study aims to determine     the long-term effect of low dose GH replacement on development of bone, muscle and fat mass;     vascular risk; and quality of life in the early years after achievement of final height, a     time known as transition. GH is thought to be essential to development of bone, muscle, and     fat mass during this time period.      Patients will be identified in the late -effects endocrine clinic, aged 16-22yrs, who are     severely GH deficient. 30 patients will be recruited to the study who wish to continue     receiving GH replacement, all of whom will receive recombinant GH. An additional 30 patients     who do not wish to receive GH replacement will provide a parallel control data.      All patients will undergo baseline assessment including examination; routine blood tests;     urine dipstick; measures on height, weight, waist, and 24 hour blood pressure. Measures will     be repeated at six months, and then annually until 25 years of age. Bone density will be     measured at baseline, after two years and at age 25yrs. Patients requesting GH replacement     will require initial additional visits to teach self injection, then 2-4wkly to assess when     correct dose of GH is achieved. The study will enable assessment of the beneficial effects of     GH replacement during transition in GH deficient survivors of cancer to be realised.   "
50092|NCT02629913|"     The Swiss company mementor has recently developed an interactive self-help intervention for     the treatment of insomnia entitled mementor somnium. This programme is based on the     guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online sessions.     An animated personal sleep coach provides relevant audio-information and asks questions to     which the patient is invited to respond. The components of the programme flexibly adapt to     the patient's responses. Aside from psycho-education, exercises and an instruction for sleep     restriction, mementor somnium includes a cognitive restructuring intervention in terms of a     Socratic dialogue. This Socratic dialogue, implemented by the animated sleep coach, is based     on a complex algorithm in the shape of an decision tree. University of Zurich's Department of     Psychology in Switzerland will test the effectiveness of mementor somnium in a randomised     controlled trial with three assessment times (pre, 6-weeks post and 3-months follow-up).     Patients suffering from insomnia will be allocated randomly to either the active intervention     group or the waitlist control group. Participants will have access to the programme mementor     somnium for six weeks. Primary outcome measure is the Insomnia Severity Index, secondary     outcome measures are Beck Depressions-Inventory revised (BDI-II), Brief Symptom Inventory 18,     and the SF-12 Health Survey. Additionally, sleep diary data will be collected.   "
50147|NCT02629237|"     1. Investigate degree of postoperative satisfaction in county level hospital glaucoma          patients.        2. Investigate the effect of educational intervention affect the degree of satisfaction in          glaucoma patients.        3. Investigate the effect factors of postoperative satisfaction.   "
50148|NCT02629224|"     The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in     patients with impaired renal function and haemodialysis.   "
50149|NCT02629211|"     To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected     IBD.   "
50093|NCT02629900|"     Participants will complete a one-month intervention where they are will restrict their daily     food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining     16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to     drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to     maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to     restrict the time period each day when food is consumed. Participants' body mass, fat mass,     and non-fat mass will be monitored non-invasively using a weigh scale and densitometry via     air displacement (Bod Pod) at 0, 2 and 4 weeks following the dietary intervention. Also,     participants will be interviewed following the final body composition measure to assess     whether or not they continued to follow the intermittent fasting approach.   "
50094|NCT02629887|"     Prospective, randomized controlled trial to be performed at one center, of term and late     preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization,     babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and     ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating     supraglottic airway. Video will be collected during resuscitation as well as written     documentation. Primary outcome will be time to spontaneous breathing, length of     resuscitation, and need for endotracheal intubation.   "
50095|NCT02629874|"     EA-230 is a newly developed synthetic compound with anti-inflammatory properties.     Pre-clinical data indicate that EA-230 may be a valuable treatment for systemic inflammation     resulting from a variety of causes such as surgery, trauma, infection, irradiation and     others. Although previous studies in healthy volunteers have shown an excellent safety     profile, the safety and tolerability of higher doses administered per continuous infusion     need to be investigated. Also, the dose-effect relation on systemic inflammation needs to be     further elucidated before a phase II trial in patients can be commenced.   "
50096|NCT02629861|"     The study is being conducted to evaluate two doses of TEV-48125 in adult patients with     episodic migraine   "
50097|NCT02629848|"     This study will evaluate progression free survival (PFS), overall survival (OS), objective     response rate (ORR), duration of response, and safety of motesanib (AMG706) in combination     with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and     carboplatin.   "
50098|NCT02629835|"     Dexamethasone prolong the duration of brachial plexus blocks, but the optimal route,     intravenous (IV) or perineural (PN), remains controversial.      This Multi-centric trial compare IV and PN dexamethasone for ultrasound-guided axillary     brachial plexus blocks (AXBs). Research hypothesis is that PN modality will outlast its IV     counterpart. Since analgesic duration and sensory duration can be influenced by intake of     pain medications and surgical trauma to small cutaneous nerves, the investigators will select     motor block duration as the main outcome.   "
50099|NCT02629822|"     The primary objectives of this study are to evaluate the antiretroviral activity and to     evaluate the safety and tolerability of open-label MK-1439A consisting of a single fixed-dose     combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate     300 mg in treatment-naive HIV-1 infected participants with selected NNRTI transmitted     resistance mutations.   "
50100|NCT02629809|"     The goal of this clinical research study is to learn if the combination of ibrutinib,     fludarabine, cyclophosphamide, and obinutuzumab can help control CLL. The safety of this drug     combination will be also studied.   "
50101|NCT02629796|"     This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP     patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of     treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin     vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6     and 12 months after the first IVIG course. Responder/No responder status will be defined at 3     month and confirmed at 12 months. Blood samples will be collected before the IVIG course at     baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample     will be collected to assess early changes of transcriptome. The CIDP diagnosis and     responder/no responder status will be confirmed by an independent committee. The     transcriptome of the patients will be individually analyzed and compared regarding     Responder/Non responder status to a control groups of 20 healthy subjects   "
50102|NCT02629783|"     Some patients with shoulder pain have decreased body awareness (BA). To some degree, pain     among these patients can be increased due to their lack in BA. Psychomotor therapy is thought     to improve BA and thereby increase the effect of traditional therapy, such as physiotherapy     and exercises.      The aim of this study is therefore to investigate if psychomotor therapy, as a complimenting     treatment to physiotherapy, decreases shoulder patients' function deficits and pain reported     on PRO's, compared to physiotherapy alone.   "
50103|NCT02629770|"     Treatment of bone and joint infections remains difficult and variable according to centres     and countries. Clindamycin given intravenously and followed by an oral route is recommended     for the treatment of staphylococcal, streptococcal and anaerobes bone and joint infections by     the French Society for Infectious Diseases. For staphylococcal bone and implant infections,     rifampin is a major drug, as it remains active in bacterial biofilm and on quiescent     staphylococci. For that reasons, clindamycin-rifampin combination therapy is frequently used     in these infections.Clindamycin is metabolized by the P450 3A4 cytochrome, an enzyme strongly     inducible by rifampin. A retrospective study published in 2010 on 70 patients treated for     bone and joint infections showed that clindamycin serum concentrations were significantly     lower when clindamycin was combined with rifampin (5.3 mg/liter vs 8.9 mg/liter; p<0.02).     This drug interaction could even be stronger with the oral route, because of hepatic     first-past effect, ending up with very low clindamycin serum concentration, a risk of     selecting resistant microorganisms and treatment failure. This latter point is an important     issue, because clindamycin has an excellent oral bioavailability and is frequently used in     oral regimens. In the above study, a wide variability of clindamycin serum concentration was     observed in the group of patients treated with combination therapy (1-12mg/l) suggesting     interindividual variability. Rifampin induction of CYP 450 3A4/A5 depends on different     receptor (PXR, RXR, LXRalpha) submitted to genetic polymorphism. Hypothesis: Plasma clearance     of clindamycin (CLclin) combined with rifampicin (CLclinrif) is higher when clindamycin is     administered by the oral route (CLclinrif OR) compared with IV administration (CLclinrif IV).   "
50105|NCT02629744|"     This study is a multi-center, single-arm, open-label study in healthy participants to assess     the pain, tolerability, injection leakage, safety, and usability of a single     self-administered subcutaneous (SC) dose of etrolizumab. Some participants will receive     needle-experience training using a needle and syringe on Days -7 and -5, and health care     professionals (HCPs) will then assess the participant's suitability to self-inject with a     prefilled auto-injector (AI). The remainder of participants will be needle naïve and will     not have previously self-injected. Eligible needle experienced and needle naive     participants will attend an AI training visit at the study site on Day -3 (three days prior     to etrolizumab dosing on Day 1). Following training and simulated injections by the     participant the HCP will determine if the participant is suitable to proceed to actual     etrolizumab dosing. All eligible study participants will self administer a single dose of     etrolizumab (by AI) on Day 1 and will be followed up to Day 85 following dosing. Pain,     tolerability, safety and usuability will be assessed.   "
50106|NCT02629731|"     This study will investigate the effect of foot orthoses on two common conditions (ankle     osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system     the group has developed to very accurately and precisely quantify foot bone motion. The     investigators will vary the design of the orthoses and subjects will be examined to find out     which are most effective at improving function.   "
50107|NCT02629718|"     To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III,     randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2     and IIA2 cervical cancer.   "
50108|NCT02629705|"     The purpose of this study is to determine whether the ingestion of the common food additive     carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes     in humans.   "
50109|NCT02629692|"     Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706   "
50110|NCT02629679|"     Adolescent substance abuse (SA), which includes the consumption of alcohol, cigarette     smoking, the consumption of drugs and other behaviors, is a significant public-health issue     in the world today. Recent data showed that prevalence of SA among adolescents in Croatia and     surrounding countries (i.e. former Yugoslav republics) is alarming and needs serious     intervention. It is hypothesized that participation in physical-exercise-and-sport (PE&S)     will reduce the tendency of young people to abuse substances. However, the literature to date     has not consistently validated the perception PE&S factors are factors which could buffer SA     among children and adolescents. One of the probable reasons for evident inconsistencies on     findings about relationship between PE&S and SA is a cross-sectional nature of studies done     so far. Therefore, the main rationale (i.e. problem) of this study is lack of current     knowledge about influence of the PE&S on SA among adolescents. The main objective of this     study is to prospectively investigate the influence of PE&S on SA among adolescents aged 17     to 18 years old. Aims of the project are: (1) to define prevalence and trends of SA among     adolescents aged 17 to 18 years old; (2) to define prevalence and trends of PE&S     participation; (3) to establish interrelationships which exist between socio-demographic,     psychological, educational-factors, and PE&S (predictors); (4) to identify multivariate and     univariate associations between: socio-demographic and SA, psychological factors and SA, PE&S     and SA, educational - scholastic factors and SA.Expected results of the project are: (1)     definition of the prevalence of SA among adolescents; (2) definition of the adolescents'     participation in PE&S; (3) identification and interpretation relationships which exist     between and within studied predictors of SA (educational factors, socio-demographic factors,     PE&S, psychological factors); (4) identification of the influence of studied predictors on     SA.   "
50111|NCT02629666|"     The increase of the elderly population leads to increased prevalence of frailty, risk for     poor health outcomes, and related health and social care costs. Lack of physical activity     (PA) and established sedentary behaviours (SB) constitute an additional burden, as they are     related to progression of chronic disease and disabling conditions. An existing initiative to     battle SB and insufficient PA levels are exercise referral schemes (ERS) implemented in     primary care, where insufficiently active individuals are referred to a third party service     (sports centre or leisure facility) that prescribes and monitors an exercise programme     tailored to the patients' needs. ERS had shown improvements in PA in the short-term, but may     have limited power to change SB and produce long-term effects. Thus, ERS might be enhanced by     self-management strategies (SMS) to promote behavioural change. Such strategies based on     social cognitive theory have been shown to increase self-confidence, power to act, and     involvement in exercise. In a first stage, a systematic review, focus groups and a     feasibility study will be conducted. Then, a three-armed pragmatic randomized controlled     trial (RCT) will assess the long-term effectiveness (18-month follow-up) of a complex     intervention on sedentary behaviour (SB) in an elderly population, based on existing ERS     enhanced by self-management strategies (SMS). It will be compared to ERS alone and to general     recommendations plus two educational sessions. The RCT will include 1338 subjects and will     have a follow up of 18 months. The effect on SB will be measured as sitting time and the     number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks, and PA as     daily counts per minute and intensity of exercise, and daily step counts. Secondary outcomes     will include: physical function, healthcare use and costs, anthropometry, bioimpedance, blood     pressure, self-rated health and quality of life, activities of daily living, anxiety,     depressive symptoms, social network, physical activity self-regulation, self-efficacy for     exercise, disability, fear of falling, loneliness, executive function, and physical fatigue.     In a subsample, the level of frailty-associated biomarkers and inflammation, and     sarcopenia-associated markers of muscle quality will be analysed. A process evaluation will     be performed throughout the trial. SITLESS will assess policy makers in deciding how or     whether ERS should be further implemented or restructured in order to increase its adherence,     efficacy and cost-effectiveness.   "
50112|NCT02629653|"     Aim of the study is to determine whether endovascular systemic cooling to a target     temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy (CEA),     is feasible and safe   "
50113|NCT02629640|"     The purpose of this study to investigate if cases of Creutzfeldt-Jakob Disease (CJD) and     other forms of prion disease are being missed in older adults living within Lothian.   "
50114|NCT02629627|"     In Mexico, obesity is a major public health problem. In recent years he has presented a     considerable increase in the population. As a result, it has triggered a proportional     increase in the incidence of cardiovascular disease and the development of Metabolic Syndrome     (METS). Abdominal obesity is one of the main components of METS which is generally associated     with insulin resistance / hyperinsulinemia. This is influenced both by the subcutaneous     adipose tissue as visceral adipose tissue. There is evidence that the visceral fat has an     important bearing on many factors of METS, like: glucose intolerance, hypertension,     dyslipidemia, and insulin resistance.      For management it requires a multidisciplinary approach, including changes in lifestyle,     psychological and nutritional intervention as well as pharmacological and non-pharmacological     support.      Among non-pharmacological therapies, there is recently the use of Conjugated Linoleic Acid     (ACL) and leucine where in its assigned properties include weight reduction, anti-atherogenic     , hypocholesterolemic and immunostimulant effect and anticarcinogenic properties. Regarding     weight reduction dominates the mechanism of action anti-lipolytic effect. But, studies are     needed to link this consumption with the increase or decrease on visceral fat in individuals     with METS.   "
50251|NCT02627833|"     Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process     leads to obliteration of the small airways. Pulmonary function tests (body plethysmography     with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is     measured. A blood test is following to determine the inflammatory status und collect miRNA.     Induced Sputum will be obtained.   "
50115|NCT02628574|"     This study will be conducted in 2 parts (Part A and Part B). Subjects ≥18 years with advanced     solid tumors will be enrolled in the study. Dose escalation will be performed in Part A.     Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities     (DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening     is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts     will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or     maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled     (Part B).   "
50116|NCT02628561|"     The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT)     in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.   "
50117|NCT02628548|"     Normal aging is associated with gradual cognitive declines. These mild neurocognitive     disturbances affect daily functioning, health status, and quality of life, and likely account     for the roughly $2.9 billion lost by the elderly each year to fraud. The goal of this project     is to compare two different 8-week training programs to promote successful neural and     cognitive aging. Changes in neural structure and cognitive function will be assessed in a     cohort of older adults, as well as the long-term stability of these changes over 24 months.   "
50118|NCT02628535|"     The purpose of this study is to evaluate the safety of MGD009 when given to patients with     B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that     can be given safely. Assessments will be done to see how the drug acts in the body     (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity     of MGD009.   "
50119|NCT02629601|"     This is a 4-week, five-arm, randomized, controlled trial to compare a standard wellness     incentive program for physical activity to four other designs.   "
50120|NCT02629588|"     Appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal     and alertness for persons in a coma or persistent vegetative state after traumatic brain     injury (TBI). Databases were searched and nine articles met inclusion criteria.   "
50121|NCT02629575|"     Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex     ISAR Stent for the treatment of real world patients with de-novo and restenotic lesions     after stand-alone angioplasty in coronary arteries   "
50122|NCT02629562|"     Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD     of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in     healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.   "
50123|NCT02629549|"     The primary end-point of the study is to determine the specificity and sensitivity of OTL38     in identifying pituitary adenomas when excited by an imaging probe. The investigators intend     to enroll 50 patients in this study. The study is focusing on patients presenting with     suspected pituitary adenomas who are considered to be good surgical candidates.   "
50124|NCT02629536|"     Migraine affects 15% of Western Australians and is a leading cause of suffering and     disability in our community (1,2). Research suggests that inflammation of the brain's     coverings (meninges) by nerve cell inflammation and the release of 'free radicals', is a     cause of migraine. N-acetylcysteine, Vitamin E and Vitamin C are powerful anti-oxidants     (free-radical scavengers) that reduce brain inflammation and nerve activity. It is therefore     possible these anti-oxidants could reduce the number and severity of migraines. We will study     90 subjects to see if a combination of N-acetylcysteine 600 mg, Vitamin E 250 IU and vitamin     C 500 mg (NEC) taken twice daily for 3 months, will reduce migraine attacks. This safe     vitamin-based therapy has never been studied and if effective, will play an important role in     migraine prevention.   "
50125|NCT02629523|"     Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR     mutations which were detected from circulating tumor DNA.   "
50126|NCT02629510|"     This study is aimed at identifying the efficacy of Tachosil® for prevention of hemorrhage in     patients with cervical intraepithelial neoplasia or cervical cancer after undergoing a loop     electrosurgical excisional procedure (LEEP).        1. Primary endpoint:           Bleeding period within two weeks after surgery Frequency of additional treatment due to          bleeding within two weeks after surgery        2. Secondary endpoint:      Amount of bleeding within two weeks after surgery Infection frequency at external genitals,     vagina and cervix within two weeks after surgery Change in life quality after surgery   "
50127|NCT02629497|"     This study investigates the potential protective effects of fatty acid supplementation     through inhibition of platelet activation. fatty acids (omega-3 and omega-6) will be     evaluated for protection from agonist-mediated platelet activation in platelets from type 2     diabetics and healthy controls. Post-menopausal women with type 2 diabetes mellitus and     healthy post-menopausal women will be treated with omega-3 and omega-6 fatty acid supplements     to determine protection from platelet activation and thrombosis in this high risk population.   "
50128|NCT02629484|"     Hip fracture surgery is a major world health care burden and concern, as it has a large and     increasing prevalence and carries very high patient mortality, disability and community     health care cost. As the commonest cause of mortality is from cardiac complications, and     cardiac disease is prevalent and frequently missed by standard care, we hypothesise that     earlier and more accurate diagnosis and treatment of cardiac pathology in this cohort will     lead to improved outcome. Focused cardiac ultrasound (FCU) is a new increasingly popular     technique used by doctors that enables earlier and more accurate diagnosis of cardiac     disorders that can be performed routinely before hip fracture surgery. Our preliminary data     of 64 patients demonstrated that routine FCU before surgery lead to a change in cardiac     diagnosis and management in 50% of patients requiring hip fracture surgery, which was     associated with a 50% reduction in mortality 12 months after surgery compared with controls.     It is therefore important for a large randomised trial to be performed to confirm or rebuke     these findings, as if true, would have a very large impact on health care and may also     improve health care and outcome in other high-risk surgical populations. The proposed pilot     study is a pilot study which aims to establish feasibility, safety, compliance and group     separation prior to commencing a definitive multicentre trial.   "
50314|NCT02627014|"     The aim of this study is to determine whether treatment of temporomandibular joint is more     effective than usual care in patients with chronic migraine and temporomandibular disorders     to reduce pain.   "
50130|NCT02629458|"     Stage I non-small cell lung cancer (NSCLC) is curable and surgery is considered the standard     of care for fit, good performance status patients. However, a high proportion of patients     with stage 1 NSCLC are elderly and/or have medical co-morbidities and are therefore at higher     risk of surgical complications. The optimal treatment for these patients is unknown. SABR may     be an equally appropriate treatment but this need to be formally assessed. Funded by the NIHR     Research for Patient Benefit, SABRtooth is a UK multi-centre, two-group individually     randomised controlled feasibility study of patients with peripheral stage I non-small cell     lung cancer considered at higher risk from surgery. In total, 54 patients are planned to be     recruited from 4 treatment sites and 2 referral sites. This study aims to determine the     feasibility and acceptability of performing a largescale definitive randomised phase III     trial comparing surgery with stereotactic ablative radiotherapy (SABR). The qualitative     substudy is an exploration of the reasons for nonparticipation in the SABRTooth trial. As the     two treatments are very different, patients may have a strong preference for either surgery     or SABR, or may feel uncomfortable to have a decision between such distinct options taken out     of their hands. Understanding why patients choose not to participate or do not take up their     treatment allocation will be crucial in demonstrating that recruiting to a larger scale phase     III trial is feasible. We will explore what patients, who have declined particpation in the     study or who intiailly consented but subsequently fail to take up their randomimsed treatment     arm, understand, perceive and feel about, how the SABRTooth trial was presented to them and     their expectations of study burden.   "
50131|NCT02629445|"     People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia     are routinely offered a defibrillator (ICD). An ICD is an implanted device which can     recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the     heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF,     can only be treated with a shock. Patients find shocks painful and this study is intended to     find out whether it is possible to pace the heart at very high rates during VF. It is hoped     that if this is possible, further research could lead to effective treatment of VF with     pacing rather than shocks, and therefore better outcomes for patients.   "
50132|NCT02629432|"     The main objective of this trial is to prove that MRI - as the imaging modality without the     use of ionizing radiation - can replace CT for structural and functional regional phenotyping     of COPD. The identification of different COPD phenotypes, such as the emphysema-type and     the airway-type, is important because therapy and prognosis will be different. The medical     problem addressed in this trial is the image-based phenotyping of COPD. The sensitivity and     specificity of MRI will be compared to Lowdose-CT serving as the gold standard. MRI and CT of     the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main     COSYCONET cohort. The reliability of the MRI results will be demonstrated. MRI phenotypes     will be evaluated visually and using software with quantitative read-outs. The agreement of     both will be determined. The additional information of MRI over CT will be assessed.   "
50133|NCT02629419|"     This is an open-label, dose-titration trial to study the efficacy, safety, and     pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous     candidiasis infections in patients who are refractory or intolerant to standard non     intravenous therapies.   "
50134|NCT02629406|"     The general aim of this study is to define the response to hypoxic challenge in patients with     diabetes. The investigation will provide response for different questions that are central     for explaining the development of complications in diabetes        -  have patients with diabetes an impaired reaction to adapt to hypoxia        -  what consequence has hypoxia challenge on respiratory and on cardiovascular regulation          in patients with diabetes        -  what consequence has diabetes on the angiogenetic response to hypoxia   "
50135|NCT02629393|"     To evaluate the safety and efficacy of ALXN1101 in neonate patients with MoCD Type A   "
50158|NCT02629094|"     Background:      People with human immunodeficiency virus (HIV) are at a high risk of getting visceral or deep     belly fat. Visceral fat can cause health problems like heart or liver disease. Researchers     want to see if a blood pressure drug can help by blocking a hormone in the body.      Objective:      To see if eplerenone reduces fat stored in the heart muscle and liver in people with HIV and     increased visceral fat.      Eligibility:      Adults ages 18 75 with HIV and increased waist circumference. Increased waist circumference     is defined as more than 40 inches in men and more than 35 inches in women.      Design:      Participants will be screened with:      Physical exam      Medical history      Blood tests      Measurements of hips, waist, legs, arms, shoulders, and neck      Magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a machine.      Electrocardiogram (EKG) to measure heart electrical activity      Transient elastography, a special ultrasound to measure liver tissue stiffness      A small piece their liver collected (optional)      Participants will have a baseline visit:      Physical exam      Medical history      Blood tests      DEXA scan to measure body fat, muscle mass, and bone density. Participants will lie on a     table while a very small dose of x-rays goes through the body.      Resting energy expenditure (REE). This measures the amount of oxygen breathed in and carbon     dioxide breathed out.      Participants will get a 1-week supply of eplerenone. They will take one pill per day.      Participants will have a follow-up visit 1 week later. They will have:      Physical exam      Medical history      Blood tests      23-week supply of eplerenone      Participants will have 5 more follow-up visits.      Participants will have a final study visit, repeating many of the screening and baseline     tests.   "
50136|NCT02629380|"     The rational of intra-articular viscosupplementation is based on both the biological and     mechanical properties of HA, which exerts positive effects on the modulation of the entire     joint environment.      The aim of the present double blind controlled study was to evaluate the effects in terms of     pain control and functional recovery provided by a single intra-operative injection of HA     performed at the end of arthroscopic partial meniscectomy.      Patients included in this trial were randomized in two treatment groups: the first one     received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy)     at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery     alone.      All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the     following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS     (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and     Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and     at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the     operated and contralateral knee were documented; also in addition, the trans-patellar     circumference of both knees was registered to assess the trend of knee swelling over time.   "
50253|NCT02627807|"     The purpose of this study is to compare individualized clinical target volume (CTV) based on     disease extension risk atlas and computer-aided delineation with traditional CTV in intensity     modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to confirm the     efficacy and safety.   "
50137|NCT02629367|"     Currently, there are no data available regarding the effect of vorapaxar on clot generation     kinetics or TIP-FCS when added to standard of care antiplatelet regimens. Potential reduction     of TIP-FCS and clot generation kinetics by vorapaxar may assist in our understanding of the     mechanism of action and in personalizing therapy in high risk patients to effectively reduce     recurrent thrombotic event occurrences. The objective of this study is to determine onset-,     maintenance-, and offset-effect of vorapaxar on platelet-fibrin clot generation kinetics by     thrombelastography (R, TIP-FCS, TG) and thrombin generation kinetics (Lag time, peak thrombin     production, time to peak thrombin generation, and endogenous thrombin potential) in     antiplatelet naïve patients and patients on mono and dual antiplatelet therapy. This is a     phase IV, prospective cohort (4 groups), non-randomized, open label, pharmacodynamics, and     safety investigation.   "
50138|NCT02629354|"     The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg     caffeine against 400 mg ibuprofen alone under fed conditions   "
50139|NCT02629341|"     The purpose of this study was to evaluate the therapeutic effect of a functional yogurt     powder on menopausal, middle-aged women at high risk of osteoporosis. The functional yogurt     powder containing Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus plantarum     3547 probiotic, was developed to benefit bone health and in the long term may contribute to     the prevention of osteoporosis.   "
50140|NCT02629328|"     This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet     repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the     CardioCel implant.   "
50141|NCT02629315|"     This study evaluates the number of lymph nodes dissected in rectal cancer specimens following     fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Half of the specimens     with be fixed in each solution.   "
50142|NCT02629302|"     The study investigates the effects of animal-assisted therapy on patients with severe     disorders of consciousness. The focus lies on the short-term biopsychosocial effects that     occur when animals are present during therapy sessions in comparison to therapy sessions     without animals, observing a group of 10 patients during 16 therapy sessions.      While half of the sessions are held in presence of an animal and half without, they are as     comparable as possible with respect to content and setting. In this study, patients in a     minimal conscious state are recruited.   "
50143|NCT02629289|"     This study is for healthy participants. This study tests single dose of the research drug     HSP-130 against two existing approved drugs United States - approved Neulasta and European     Union-approved Neulasta.   "
50144|NCT02629276|"     The aim of this study was to evaluate potential differences in somatosensory function in     patients with unilateral NSNAP with and without positive ND compared to healthy controls.     Furthermore, we determined whether there are any differences between groups in symptom     severity, functional deficits, psychological parameters, quality of life and sleep.   "
50145|NCT02629263|"     Purpose of Study (The Effect of Viscous Fiber on Glycemic Control (VF & GC) in Individuals     with Diabetes Mellitus.      According to the World Health Organization, about 347 million individuals are living with     diabetes. (http://www.who.int/features/factfiles/diabetes/facts/en/, accessed on Nov. 23,     2015). Over the last decades, dietary fibers, namely dietary viscous fibers, have emerged as     a nutrition component that may improve the postprandial glycemic response and hence aid in     long term diabetes management. It is believed that supplementation with viscous fibers can     control blood glucose by increasing viscosity of the gastric digesta, hence delaying gastric     emptying and retarding entry of glucose into the bloodstream to result in a diminished     postprandial rise in blood glucose. (Chutkan et al., 2012).      Currently, the evidence of the relationship between viscous fibers and diabetes is mixed. The     systematic review method depends on combining data from many small studies in order to get a     pooled estimate of the true effect. The purpose of this study is to conduct a systematic     review and meta-analysis of randomized controlled trials (RCTs) investigating the fasting     glycemic and insulinemic effect of viscous fiber supplementation. We hope the findings of     this study will play a key role in developing the nutritional guidelines for individuals with     diabetes mellitus.   "
50146|NCT02629250|"     Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop     more complications following major surgery. Quite a few researches have shown the benefits of     goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve     outcome during major surgery. However there is concern that inotropic therapy for a     supernormal oxygen delivery (DO2I) may lead to an increased incidence of myocardial ischemia.     Even though the meta-analysis has stated that DO2I strategy could possibly reduce the     incidence of cardiac complication than stroke volume optimization strategy, there are very     few evidence available in the literature regarding the effect on myocardial ischemia in     surgical patients, especially in non-cardiac surgical patients. This study is undertaken to     test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial     ischemia in the elderly high-risk surgical patients.   "
50315|NCT02627001|"     This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral     Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat     medics.   "
50159|NCT02629081|"     When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not     respond to conventional treatment (a class of medications called proton pump inhibitors), it     is important to be able to distinguish between erosive GERD and non-erosive GERD (called     NERD).      Currently the best method the investigators have to make this distinction is esophageal     24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus     through the nose and having the catheter maintained in this position for 24 hours This test     is invasive, can be uncomfortable, and it is expensive and time consuming.      The investigators are hoping that image enhanced technology will identify characteristics     that are found more commonly in patients with non-erosive GERD compared to controls and     therefore provide evidence that may allow us to replace pH and impedance testing with the     image enhanced endoscopy as the best way to diagnose NERD.      Participants will be either patients undergoing an upper endoscopy as part of their standard     clinical evaluation for heartburn that does not respond to PPIs or patients undergoing     standard clinical evaluation endoscopy for other reasons.   "
50150|NCT02629198|"     There is current interest in the role of vitamin D in the prevention and treatment of many     chronic diseases, including osteoporosis, cancer and neurological disease. The majority of     vitamin D in the UK comes from the action of sunlight on skin, and very little from dietary     sources. Half of the adult United Kingdom (UK) population have vitamin D insufficiency     (according to the Institute of Medicine definition). There are still several important     unknowns, including what the optimum levels of vitamin D are, and whether the same intake of     vitamin D is appropriate for all sections of the population.      Low 25(OH)D and high parathyroid hormone (PTH) have been observed in people with high     adiposity (obesity), and the summer rise in vitamin D is blunted in obesity. The potential     causes of low 25(OH)D levels include an inadequate supply of vitamin D (by reduced sunlight     exposure or poor nutrition), the large pool size of adipose tissue or increased metabolic     clearance rate.      The investigators will measure metabolites of vitamin D and the kinetics of 25(OH)D using     stable isotope techniques in lean, overweight and obese men, women and children to establish     whether age, gender and obesity affect vitamin D metabolism and clearance rate.      If low 25(OH)D in obesity is related to poorer skeletal health and is due to increased     clearance of 25(OH)D or large pool size, then total requirements, and hence supplementation     requirements, would be larger for obese people than for lean people.   "
50151|NCT02629185|"     High body weight is protective against hip and spine fracture, but has been found to increase     the risk of humerus, foot and ankle fracture. Increasing understanding of the actions of     adipokines on bone suggests that there may be complex effects on different aspects of bone     geometry and microarchitecture and that these effects may vary depending on whether     adipokines act directly on bone cells or through the central nervous system and between     cortical and trabecular compartments. Previous research is limited by the use of areal     dual-energy x-ray absorptiometry (DXA) scans which may be inaccurate in obese populations due     to increased body thickness.      The aim of this study is to investigate the effect of obesity on bone mineral density, bone     geometry, bone microarchitecture and bone strength of the hip, lumbar spine, distal radius     and tibia.      This is an observational, cross-sectional study of normal weight and obese individuals     matched by age, gender, height, postcode and smoking. The total number of subjects will be     240; men and premenopausal women ages 25 to 40 years and men and postmenopausal women ages 55     to 75 years. DXA, high-resolution peripheral computed tomography (HR-pQCT), quantitative     computed tomography (QCT) and finite element analysis will be used to assess bone structure     and strength. Biochemical markers of bone turnover and hormones related to bone metabolism     will also be measured in order to identify potential mediators of the effects of obesity on     bone structure and strength.      A sub-study has been included to evaluate the interaction of fracture risk and cardiovascular     risk in obese and non-obese individuals. There is evidence of an interaction between bone     mineral density (BMD) and cardiovascular risk and test the hypothesis that there are common     pathways linking BMD and cardiovascular risk, including fat secretion of inflammatory     cytokines e.g. interleukin-1 and adipokines e.g. leptin and adiponectin. Ultrasound based     assessments of vascular function will be used to assess cardiac risk and relate these     measures to bone density.      Obese individuals have lower circulating levels of 25OHD. This may be due to poor nutritional     intake, reduced sunlight exposure or the vitamin D being stored in fat tissue. The     investigators will measure levels of 25OHD in lean, overweight and obese men and women to     examine whether 25(OH)D is related to age or gender and whether low 25OHD in obesity affects     bone health in subsets of lean, overweight and obese participants of different ages.   "
50152|NCT02629172|"     The main objective of this study is to evaluate the safety and effectiveness of     paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily     practice in Japan.   "
50153|NCT02629159|"     This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to     Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a     stable background of Methotrexate (MTX) and who have an inadequate response to MTX.   "
50154|NCT02629146|"     This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each     participant will receive all three drugs (midazolam, fentanyl, placebo) on three different     occasions (study visits) and the effect on different pain stimuli will be tested.   "
50155|NCT02629133|"     This study will develop and assess an innovative, high-reach, easily implementable, low-cost     computer-delivered intervention (Safe and Healthy Experiences; The SHE Program) that will     address known barriers in early identification and intervention with sheltered battered women     with IPV (intimate partner violence) and substance use.   "
50156|NCT02629120|"     Chronic granulomatous disease (CGD) affects white blood cell function. Currently, the only     curative treatment is bone marrow transplant to replace the abnormal stem cells with new ones     (donor cells) capable of making a normal immune system. Transplant problems include graft     versus host disease (GvHD) and graft rejection. With GvHD, donor cells attack the recipient s     normal tissue. Researchers want to use preparation drugs and a high cell dose to increase     graft success. They want to use 2 immunosuppressive drugs (cyclophosphamide and sirolimus) to     lessen the risk of GvHD.   "
50157|NCT02629107|"     Background:      An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the     louder the sound needed to wake a person, the deeper the person s sleep. Researchers are     using functional magnetic resonance imaging (fMRI) to study people during sleep so they can     view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like     the EEG.      Objective:      To measure brain activity during sleep using fMRI and EEG.      Eligibility:      Healthy people ages 18 34 who can sleep on their back for several hours.      Design:      Participants will be screened online about their sleep and general health.      At a screening visit, participants will have:      Physical exam      Hearing exam      MRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants     will lie down on a bed that slides into the scanner, which is shaped like a cylinder.      Participants will wear an actigraph on their wrist that records their motor activity.      Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed     times and limits on alcohol, caffeine, and nicotine.      At the 3-day inpatient visit, participants will have:      Hearing exams.      Female subjects will have a urine pregnancy test.      fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer     screen inside the scanner.      EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in     the scanner.      Participants will be asked to try to sleep while researchers collect fMRI and EEG data.     Participants eyes will be monitored with a video camera. Headphones will deliver sounds to     wake them up throughout the night.   "
50182|NCT02628782|"     The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access     sites for quick hemostasis and ambulation in patients who have undergone large bore     endovascular catheterization procedures.      The study hypothesis is that the VCD is safe and efficient in achieving hemostasis in the     study population.   "
50316|NCT02626988|"     What is the role of Agricultural biodiversity in improving diet diversity, quality and     nutrition?   "
54059|NCT02577991|"     Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia     compared to intravenous steroids or a control group   "
50160|NCT02629068|"     The purpose of this study is to develop and test a social media-based (Facebook) intervention     that provides support and skills to parents with adolescent children in treatment for     substance abuse. The Facebook intervention, PURPOSE, will be 8 weeks long and led by other     parents (peer leaders). Peer leaders will go through 2 2-3-hour training sessions and be     assessed at the end to confirm their understanding of study protocol and procedures. The     study PI will lead 2 short (2-weeks) trial tests of various segments of the intervention to     test out content and procedures. Then, a pilot trial with 80 parents, 40 randomized to     PURPOSE and 40 randomized to treatment as usual (TAU), will be done to test how useful     PURPOSE can be in promoting parents' engagement in their child's treatment and recovery while     reducing their own distress and feelings of shame/stigma. Parents will do a phone interview     at the start of PURPOSE and again at the end of the 8 weeks.   "
50161|NCT02629055|"     The aim of the present study is to investigate whether additional titration on surface     electromyography (EMG) of the diaphragm and intercostal muscles improves the outcome of     chronic non-invasive ventilation in patients with COPD and stable chronic hypercapnic     respiratory failure in terms of better gas exchange after six weeks, lung function, patient     comfort and compliance, and less patient ventilator asynchrony. Therefore, the investigators     set up a randomized, two-armed crossover trial comparing regular titration with additional     respiratory EMG titration of NIV.   "
50162|NCT02629042|"     Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful,     representing one of the main reasons for consulting dental emergency. The recommended     emergency care is a partial endodontic treatment under local and/or locoregional anesthesia.     The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by     removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours     after. The literature reports major difficulty in obtaining adequate anesthesia in the     mandible to perform partial endodontic treatment, especially for the mandibular molars. This     results in a very painful care for the patient. The management of this type of emergency is     costly in terms of equipment and time for health facilities. Patient comfort, cost saving and     rationalization of the care time justify the search for an alternative to emergency partial     endodontic treatment. In current practice, the short course oral corticotherapy is used in     the management of oral pain from inflammatory origin. Glucocorticoids, thanks to their     anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The pulp     inflammation can be treated with this molecule: the effectiveness of intraosseous local     steroid injection for irreversible pulpitis of mandibular molars has already been shown but     results in local comorbidities and requires specific device. Oral administration of     short-course prednisolone is simple and safe but its effectiveness to manage pain caused by     irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone     has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness     between intravenous and oral administration of this molecule was reported. This oral     treatment could limit comorbidities and technical difficulties related to intraosseous     injection and could delay the endodontic treatment to 72 hours in optimal conditions of     anesthesia for the patient. Despite the difficulties described for the partial endodontic     treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a     non-inferiority design was chosen to compare the effect of a short-course oral corticotherapy     to a partial endodontic treatment for the reduction of pain at the emergency care of the     irreversible pulpitis in mandibular molars. The intervention arm will receive an oral dose of     prednisolone (1 mg/kg) during the emergency visit followed-up by one morning dose by day     during three days and the reference arm will have partial endodontic treatment. Both groups     will have planned complete endodontic treatment 72 hours after enrolment.   "
50163|NCT02629029|"     Surgical reconstruction of anatomical structures after head and neck cancer resection has     made enormous strides in the past 20 years with advancing flap techniques and the usage of     perforating vessels, but accurate and consistent identification of these perforators has     remained a challenge due to the varying anatomy of vasculature in the donor region. Computed     tomography angiography (CTA) has been used increasingly in preoperative free flap perforator     mapping for breast reconstruction but has been limited in head and neck applications. In     addition, indocyanine green (ICG) assisted NIR fluorescence angiography has been developed     for intra-operative flap assessment. In this study, the investigators propose to assess a     previously undocumented, multi-modal imaging technique with preoperative dual energy CTA to     design and intraoperative ICG assisted NIR angiography to assess free flap in head and neck     reconstruction.   "
50164|NCT02629016|"     This study will evaluate the feasibility of providing an onsite mindfulness intervention,     delivered as part of the school health curriculum, to help high school-attending adolescents     cope with stress.   "
50165|NCT02629003|"     The purpose of this study is to determine the dosimetry for the Positron Emission Tomography     (PET) tracer [11C]Cimbi-36 in two different Carbon-11 labelling positions. This information     will contribute to determining whether [11C]Cimbi-36 can be optimized by changing the C-11     labelling position.   "
50166|NCT02628990|"     The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol     ester either with or without added camelina oil on the serum cholesterol levels in moderately     hypercholesterolemic subjects   "
50167|NCT02628977|"     The primary purpose of this study is to ascertain the effectiveness of tailored, peer based     sleep health education and social support in increasing adherence rates to recommended     Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive     Sleep Apnea.   "
50168|NCT02628964|"     The purpose of this study is to examine the feasibility of using e-cigarettes as a method for     harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking     outcomes. Participants will be randomized to receive either e-cigarettes with nicotine     cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.   "
50196|NCT02628600|"     This open-label safety extension study will assess the safety and tolerability of once daily     dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in     subjects with non-tuberculous mycobacterium (NTM) lung infections due to Mycobacterium avium     complex (MAC) who are refractory to therapy in Study INS-212.   "
77672|NCT02269189|"     Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)   "
50183|NCT02628769|"     This study examines the potential benefit of a new antibiotic, Solithromycin, for the     long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). Solithromycin is     hypothesised to work by reducing inflammation in the lungs of patients with COPD. Stable COPD     patients will receive treatment with solithromycin for 28 days and comparisons will be made     between any effects observed with Solithromycin and a placebo. This will include any changes     in inflammatory proteins, lung function and reported symptoms.   "
50184|NCT02628756|"     Women between 18-39 years old who had been infertile (primary or secondary) for at least 1     year were recruited. In a parallel assignment eligible participants were randomized to     receive either a single, site-specific endometrial injury guided by hysteroscopy (Study     group) or no intervention (Control group). Natural cycle folliculometry + timed sexual     intercourse were offered for all participants for the ongoing and the immediate 2 concecutive     cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the     secondary outcome measures.   "
50169|NCT02628951|"     Vascular endothelial growth factor is expressed in gastric cancer, and expression has been     associated with more aggressive clinical disease. Vascular endothelial growth factor     expression has been noted in 51% of gastric cancer specimens in one series (versus no     expression in normal epithelium or superficial gastritis). Vascular endothelial growth factor     expression in resected gastric cancer is associated with tumor recurrence and shorter     survival. Maeda et al. studied 95 gastric cancer patients following resection with curative     intent, and noted a significantly shorter survival in 34 patients whose tumor endothelium     expressed VEGF (as detected via immunohistochemistry) versus 61 patients without endothelial     VEGF expression (p<0.05). Yoshikawa and colleagues observed similar survival differences in     resected gastric cancer patients based on levels of circulating (plasma) VEGF at time of     resection. Circulating VEGF is significantly higher in gastric cancer patients versus those     without neoplasia. Elevated circulating VEGF was also associated with shorter survival in a     European cohort undergoing gastric cancer resection; there was no survival beyond 30 months     in 24 patients with serum VEGF >533 pg/mL versus a 30-month survival rate >35% for 34     patients with VEGF levels below this threshold (p<0.0001, log-rank test). Recently, Jüttner     and colleagues noted reduced survival following R0 resection in gastric cancer patients whose     tumors expressed VEGF-C or VEGF-D, with the most robust association between expression and     reduced survival for patients whose tumors expressed both VEGF-C and VEGF-D.      Investigational inhibition of VEGF Receptor 2 in gastric cancer xenografts (TMK-1 cell line)     is associated with reduced tumor growth. DC101 therapy in this model is associated with     significant reductions in tumor vascularity (as measured by CD-31 expression) and increases     in endothelial and tumor apoptosis.      The results of the REGARD and RAINBOW studies are consistent with the idea that tumor-     related angiogenesis contributes to the pathophysiology of gastric cancer and demonstrate the     ability of ramucirumab to represent an improvement in the care of patients with gastric     cancer whose disease has progressed after prior chemotherapy.   "
50170|NCT02628938|"     The aim of this experiment is to investigate the effect of Miswak on oral malodor and to     determine whether this effect -if present- is the result of the mechanical action of Miswak     or the chemical effect of its extract   "
50171|NCT02628925|"     Delirium is one of the most common complications among elderly hospitalized patients,     postoperative patients and patients on intensive care units. The reported prevalence is     between 11 and 80 %. Delirium is associated with a high morbidity and threefold higher     6-month mortality. The Nursing-Delirium Screening Scale (Nu-DESC) is a screening tool with a     high sensitivity and specificity.      The purpose of this study is to translate the Nu-DESC to danish and evaluate afterwards its     feasibility and understanding by different medical staff.      Material and methods:      The Nu-DESC will be translated after International Society for Pharmacoeconomics and Outcomes     Research (ISPOR) guidelines to Danish by permission of the original author.      The evaluation will be performed, by filling out evaluation forms, where the feasibility and     understanding will be rated on a 6 step Likert scale.   "
50172|NCT02628912|"     This study is being done to learn about how the participants lungs and heart are working     after treatment for throat cancer. The investigators are looking to see if there is a     long-term impact on overall health from the cancer treatment. The long-term goal of this     study is to compare the participants overall quality of life to similarly aged people who     have not had throat cancer.   "
50173|NCT02628899|"     To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with     commercially available bioprostheses in elderly patients with severe, symptomatic aortic     stenosis (AS) who are low‐risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).   "
50174|NCT02628886|"     Streptococcus pneumoniae is responsible for over 10 percent of death in children under five     and many of these deaths occur in early infancy before the current pneumococcal schedule is     effective and nearly half occur in sub Saharan Africa.      The PROPEL trial will examine the effect of either a maternal or a neonatal dose of a     pneumococcal conjugate vaccine on pneumococcal colonisation in the nose which can be used to     measure the risk of disease in early life.      600 Expectant mothers will be randomized at between 28 and 34 weeks to a maternal group, a     neonatal group or a control group in equal number (200 per group). Their subsequent born     offspring will be followed up until nine months of age. Infants born from expectant mothers     in the maternal and control group will receive their subsequent pneumococcal conjugate     vaccination according to the national Expanded Programme on Immunisation (EPI) schedule in     the Gambia at 8, 12 and 16 weeks while infants born to expectant mothers in the control group     will receive the pneumococcal conjugate vaccine within 48 hours of birth and at 8 and 16     weeks of life. Randomization will be undertaken by defined un-blinded members of the clinical     trial team who will be delegated for this task and who will not be involved in any other     trial related procedures Pregnant women who are willing and who are identified by the staff     of the government antenatal clinic as being potentially eligible according to gestation     (assessed initially according to the date of the last menstrual period (LMP) - if known, or     the fundal height), will be referred to a member of the clinical trial team.      Those who remain interested in participation having had the details of the study explained     will have basic demographic, obstetric and contact details collected and will be invited, at     a time of their convenience, to the Medical Research Council (MRC) clinical trial site for     the formal informed consent process to be completed. Following informed consent, pregnancy     will be confirmed with a urinary pregnancy test. Initial screening (e.g. for past-obstetric     history and past-medical history etc) will be undertaken at this point along with screening     bloods for serology (HIV, hepatitis B and syphilis) and haematology (haemoglobin and sickle     test). A dating ultrasound scan (USS) will also be undertaken by designated clinical trial     staff. On completion of screening, expectant mothers who are confirmed to be eligible     according to the defined inclusion and exclusion criteria will be enrolled and randomized in     parallel into one of three equally sized groups mentioned above (maternal, neonatal,     control).      According to the group into which they have been randomized, mothers will receive a dose of     PCV13 and tetanus toxoid [maternal group], placebo (0.9% sodium chloride) and tetanus toxoid     [control group] or tetanus toxoid alone [neonatal group]. From this point on, the maternal     and control groups (now 'Routine EPI Schedule') will be followed up in exactly the same way     for the purposes of interventions and all endpoint assessments. Infants in the neonatal group     ('Neonatal Schedule') will be followed up according to the schedule outlined.      At the time of presentation to the delivery unit a blood sample for serology and malaria     Rapid Diagnostic Test (RDT) and an nasopharyngeal swab (NPS) sample will be obtained prior to     or shortly following delivery. Immediately following delivery a sample of cord blood will be     obtained and as soon as possible an NPS sample will be taken from the newborn. Anthropometric     measurements will be taken from the newborn and an examination conducted. Once there has not     been any contraindication to vaccination identified, all newborns will be administered the     routine EPI vaccines according to the schedule in The Gambia (BCG, Hepatitis B and OPV).     Those newborns in the Neonatal group will additionally be administered a single intramuscular     (IM) dose of PCV13. At two, three and four months, infants will be administered the routine     EPI vaccines. Those infants in the Maternal and Control Groups (Routine EPI Schedule) will     additionally receive PCV13 at eight, 12, and 16 weeks while those in the Neonatal group will     receive the vaccine at eight and 16 weeks only having received the first dose at birth. All     infants will additionally receive a single dose of the inactivated poliovirus vaccine (IPV)     at 16 weeks in line with the routine EPI schedule in The Gambia.      Following the vaccines administered to expectant mothers and following the vaccines     administered at birth, home visits will be undertaken on day 1 to 6 to collect solicited     local and systemic adverse (for PCV only) reactions and any unsolicited. A day 7 safety     clinic visit will be conducted following the vaccines administered to expectant mothers and     following the vaccines administered at birth. Infant will attend the clinical trial site for     NPS and blood samples to be taken at specific time points.   "
50175|NCT02628873|"     The study evaluates whether saline infused sonography (SIS) with directed air bubbles for     hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray     hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in     patients who are undergoing an Essure confirmation test.   "
50176|NCT02628860|"     This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing     perioperative transfusion in iron deficiency anemia patients anticipating     pancreatoduodenectomy.   "
50177|NCT02628847|"     This is a small, pilot randomized clinical trial of administering sildenafil citrate to     individuals within 10 days of ischemic stroke who have motor impairment and who are     undergoing inpatient rehabilitation compared to placebo. The primary outcome is motor     recovery at one and three months.   "
50178|NCT02628834|"     Ten patients who were referred to receive physiotherapy and 10 healthy volunteers will be     participants of the study.Following the initial evaluation, participants with multiple     sclerosis will take the fascial mobilization for their posterior crural muscle group and     hamstring distal tendons which connects the crural bones at first day. After the day     following the first visit participants will asked to come again and stretching exercises will     apply to plantar muscle groups after the evaluation. Every participants will evaluate with     the following assessment tools: Modified Ashworth scale will use to evaluation of severity of     plantar flexor spasticity. Static and dynamic loading parameters will assess with dynamic     pedobarography.   "
50179|NCT02628821|"     Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of     gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well     as respiratory outcomes and possible secondary side effects.      SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants     that met intubation criteria) and also is used electively for extubation when nCPAP     extubation has previously failed or infants with Prolonged mechanical ventilation (more than     15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).   "
50180|NCT02628808|"     The main objective of the study is to define, for Autism Spectrum Disorder, the extent of     genetic variation in synaptic pathways that may be targeted for therapeutic development. For     this purpose the investigators will take advantage of large, well-characterized cohorts of     patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of     selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried     out in these cohorts with deep coverage of coding regions and a strong focus on previously     untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing     and exome sequencing, available for some of these patients, will be integrated in the overall     analysis. The investigators will strongly emphasize the establishment of comprehensive     genotype/phenotype correlations and set up an induced Pluripotent Stem Cells collection from     selected patients with synaptic mutations for functional and expression analysis.   "
50181|NCT02628795|"     This single-blind, randomized, controlled trial is designed to test the effect of an     intensive, 16 week exercise rehabilitation program (progressive resistance training +     functional mobility training) vs. usual care on restoration of muscle mass and mobility after     total hip (THA) or knee (TKA) arthroplasty in men and women with end-stage osteoarthritis.     The molecular basis underlying the trial is the presence of significant muscle inflammation     susceptibility in many of these individuals, and the expectation that the more intensive     intervention will overcome this inflammatory burden to facilitate recovery.   "
50185|NCT02628743|"     The purpose of this open-label, single arm study is to further evaluate long-term     tolerability, safety and efficacy outcomes of olesoxime in participants with SMA who     previously participated in one of the following two clinical studies: TRO19622 CL E Q 1115-1     (NCT ID XXX, open-label Phase Ib, dose-ranged, single and multiple dose study) or TRO19622 CL     E Q 1275-1 (NCT01302600, Phase II, multicenter, randomized, adaptive, double-blind, placebo     controlled study).   "
50186|NCT02628730|"     Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart.     Tablets to try to normalise the heart rhythm rarely work well. As a result, doctors have     devised a treatment called catheter ablation in which special wires are used to deliver heat     energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many     patients (almost 1 in 2), some of these ablation lesions recover, and this leads to AF     recurrence. Many of these patients then need a second procedure to deliver further ablation     at these recovered areas.      Recent research has shown that monitoring of heat delivery with a factor called Ablation     Index may be useful in predicting which ablation lesions are less likely to recover.     Therefore, we aim to carry out AF ablation guided with Ablation Index (AI) and observe     whether this will be associated with better durability of ablation lesions, and thereby     better freedom from AF.      This study will include patients with persistent AF, those whose AF episode(s) last for     longer than seven days. All patients participating in the study will undergo an initial     ablation treatment guided by ablation Index . All patients will undergo a repeat procedure     8-10 weeks after their initial treatment. Any gaps found during the second procedure will be     closed again by delivery of ablation.      All participants will be issued with a simple to use handheld heart rhythm monitor, and asked     to make a 30-second recording of their heart rhythm each day and also whenever they have     symptoms. The monitor stores these recordings and they will be downloaded at review     appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation     procedure.   "
50187|NCT02628717|"     Since the availability of interferon free direct acting antivirals (DAA) the centers     authorized to prescribed these drugs in Austria submitted their data to a central data base     (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced     liver disease (F3/4)   "
50188|NCT02628704|"     Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib     (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose     dexamethasone in patients with relapsed/refractory multiple myeloma.   "
50189|NCT02628691|"     Data on the progression of liver fibrosis in patients co-infected with HIV taking effective     suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline     are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier     (than F3-F4) treatment in co-infected patients.      Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the     opportunity to monitor for short-term fibrosis progression in a cohort of co-infected     patients with initial no-to-moderate fibrosis being identified during another ongoing study     (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV     treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.      The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized     follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C     disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk     Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2,     -3 or -6 but are not considered in immediate need of HCV treatment.      All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital     Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all     genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and     no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to     participate.      Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be     enrolled in this study.      Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months.     These patient visits will comprise of a history taking and physical examination focused on     hepatic disease and blood sampling for basic hematologic and hepatic function parameters.     Additionally, patients will be referred every year for ultrasound and transient elastography     measurements and sampling for some additional liver function tests and measurement of HCV-RNA     viral load.   "
50190|NCT02628678|"     The primary objective of this study is to determine the 5-day tolerability of one     commercially available prebiotic food ingredient, FOS, in healthy human subjects with and     without diet control.   "
50191|NCT02628665|"     The therapy of photofrin PDT was effective in improving life quality of patients with     advanced esophageal and/or gastric cardiac cancer and the time optimizing for employing laser     irradiation was of great importance.The purpose of this study is to evaluate the clinical     efficacy and adverse effects of Photodynamic Therapy (PDT) on esophageal and/or gastric     cardiac cancer during different time after inject photofrin.   "
50192|NCT02628652|"     The primary objective of this study is to determine the tolerability of two polyglycan food     ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator     in this study will be Inulin FOS, a commercially available glycan supplement.   "
50193|NCT02628639|"     The purpose of this study is to evaluate whether personalized stimulations can improve the     detection of electrophysiological signs of awareness in patients with disorders of     consciousness.   "
50194|NCT02628626|"     Compare the effects of a combination of colesevelam and clonidine to placebo on bowel     symptoms in patients with urge or combined type of FI.   "
50195|NCT02628613|"     The purpose of this study is to compare the efficiency and safety between paclitaxel combined     with carboplatin and vinorelbine combined with epirubicin when used in neoadjuvant     chemotherapy for locally advanced (IIb-IIIc) HER-2 (-) breast cancer with TEKT4 variation.   "
50317|NCT02626975|"     MRI study of ballooning and ligamentisation short transplants of anterior cruciate ligament     (ACL) according to DT4 technique in 60 patients with more than one year of follow up.   "
50205|NCT02628431|"     The elfitor device is a small non invasive device that uses dynamic light scattering to     measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this     study, the investigators will investigate whether the elfitor device is able to detect     changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the     investigators will investigate changes in cutanuous blood flow in different parts of the body     during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and     overdosing of general and local anesthetics may be prevented, resulting in favorable     hemodynamics and better intra and postoperative pain relieve.   "
50354|NCT02626481|"     This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in     MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease,     resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide.      There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling     have already been determined in previous phase 1-2 dose escalation studies. There is no     randomization.   "
50197|NCT02628587|"     Ischemic heart disease is the leading cause of death and disability in developed countries     and is responsible for a third of deaths in persons over 35 years . The most severe form of     ischemic heart disease is sudden death and acute coronary syndrome (ACS).      There is evidence that early and optimal treatment of ACS decreases mortality. Within the     optimal treatment, these patients must receive a reperfusion therapy as mechanical or     pharmacologic treatment. In addition to reperfusion treatment, antiplatelet therapy is a     central part of the management. Aspirin plus a P2Y12 inhibitor have been shown to decrease     mortality. In our country, clopidogrel is the more accessible and used P2Y12 inhibitor;     however, it has been shown to have a wide variability in response and this variability could     be influenced by different pharmacological, genetic and environmental factors.      Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS     patients treated with clopidogrel. Due to their frequent prescription, generic clopidogrel     efficacy must be evaluated. The purpose of this study is to compare the platelet reactivity     in patients with ACS receiving clopidogrel generic versus patent.   "
50198|NCT02628522|"     Investigators performed a prospective pilot study to test the feasibility and safety of     autologous adipose derived regenerative cell (ADRC) transplantation in treatment of anal     fissures. The study included 6 patients with chronic anal fissures with symptoms that had an     average duration of 24 months. All patients were candidates for surgical treatment as all     previous conservative treatments were unsuccessful. The pain level was measured using the VAS     scale and was recorded before the treatment and on every consultation following the     treatment.      The initial hypothesis is that application of ADRCs may be an alternative to lateral     sphincterotomy and a reliable procedure to avoid fecal incontinence.   "
50199|NCT02628509|"     The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand     Factor-multimerizaton defects associated with devices in cardiovascular diseases.   "
50200|NCT02628496|"     The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser     microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic     assessment of laryngeal lesions.      In order to achieve this purpose, this study will prospectively enroll patients with clinical     evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo     a formal intraoperative biopsy of their lesion. While in the operating room, prior to     performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding     tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard     protocol, and the diagnostic results from CLM and the formal biopsy will be compared.   "
50201|NCT02628483|"     The health benefits of omega-3 fatty acids have been extensively examined in many published     studies, and these benefits have been observed in patients with a diversity of conditions and     diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis,     thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline,     periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to     healthy individuals, in terms of preventative health benefits. The balance between omega-6     long chain fatty acids and their omega-3 counterparts is important in health maintenance. An     omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio     in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014     study of the dietary habits of U.S. adults revealed that, in general, North Americans do not     meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to     be considered, in order to help this population meet their daily needs. Both the Academy of     Nutrition and Dietetics and the American Heart Association suggest a prudent approach in     recommending an increased intake of omega-3 fatty acids. Although both organisations     recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also     recognise that supplementation may also be required in order to meet target values,     particularly in at-risk populations.      Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA     and DHA and are available in varying forms including ethyl ester and high triglyceride forms.     Differences in product formulation have been shown to have varying health effects.   "
50202|NCT02628470|"     Currently, there are many studies about the effects of manual therapy on pain, but there are     not enough studies to know what are the mechanisms that cause these effects.      Although there is a research measuring neuromodulators substances after a cervical and dorsal     manipulation, it has been done in healthy subjects and there is no information about     mobilization. This work aims to select a sample with chronic neck pain, incorporating the     cervical mobilization as a therapeutic approach to compare the effects of both techniques     because not all patients accept the manipulation as a treatment technique (mobilization is     much better tolerated) and to verify that the liberation of cortisol is not just caused by     the stress on the joint manipulation and the psychological stress and expectation may be     important.      The hypothesis of this paper is that cervical manipulation and mobilization in subjects with     chronic neck pain there will increase salivary cortisol levels.      It is also expected a little increase in the expectation of being manipulated group because     of the psychological stress.      It is expected an improvement in the neck disability, pain and range of motion in the     intervention groups immediately after and in the three groups the following week after the     exercise.      The main objective of the study is to measure and analyze changes in salivary cortisol     concentrations after the intervention in the three groups. Secondary objectives is to analyze     the changes in range of motion and disability caused by neck pain neck pain level   "
50203|NCT02628457|"     There are two purpose of this study, first is to find whether arthroscopic rotator cuff     repair is changing the appearance of supraspinatus muscle atrophy in each and every patient.     Second, is to find how much approximate change one can expect depending on age and tendon     retraction   "
50204|NCT02628444|"     The aim of the study is to assess the safety of the primary series vaccine schedules and the     booster vaccination      Primary Objectives:        -  To demonstrate the non-inferiority of the immune response elicited against each dengue          serotype by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue          vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose          schedule (CYD Dengue vaccine group) 28 days post-final vaccination.        -  To demonstrate the non-inferiority of the immune response elicited against each dengue          serotype by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue          vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose          schedule (CYD Dengue vaccine group) 28 days post final vaccination.        -  To demonstrate the non-inferiority of the immune response elicited against each dengue          serotype 28 days after administration of a single booster dose of tetravalent CYD          vaccine      Secondary Objectives:        -  To demonstrate the superiority of the immune response elicited by tetravalent CYD          vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the          immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine          group) 28 days post-final vaccination.        -  To demonstrate the superiority of the immune response elicited by tetravalent CYD          vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the          immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine          group) 28 days post-final vaccination.        -  To describe the neutralizing antibody levels of each dengue serotype at 28 days post          Dose 3 to the Ab levels immediately before receiving booster injection in all 3 CYD          vaccination groups.        -  To describe the neutralizing antibody levels of each dengue serotype at 28 days          post-dose 2 and 28 days post-dose 3 from CYD Dengue vaccine group in a primary series          schedule.        -  To demonstrate the superiority of the immune response elicited against each dengue          serotype 28 days after administration of a single booster dose of tetravalent CYD          vaccine.        -  To evaluate the safety profile of CYD vaccine after each and any injection   "
50206|NCT02628418|"     Hand recovery following cerebral stroke is complex and requires intensive training. The     investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand     rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand     strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by     stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index <3) were randomized.     Patients in the Treatment group received intensive hand training with Gloreha, a hand     rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of     the fingers, with multisensory feedback. Patients in the Control group received conventional     intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity     Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch     test) were measured at baseline and after rehabilitation, and the differences between final     and basal results were compared between groups.   "
50207|NCT02628405|"     This phase I/II trial studies the side effects and best dose of lenalidomide when given     together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and to see how well they     work in treating patients with diffuse large B-cell lymphoma that has returned after a period     of improvement and that has not responded to previous treatment. Drugs used in chemotherapy,     such as rituximab, ifosfamide, carboplatin, etoposide, and lenalidomide, work in different     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving lenalidomide with R-ICE may be a better     treatment for patients with diffuse large B-cell lymphoma.   "
50208|NCT02628392|"     The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a     compared with placebo in patients with type 2 diabetes mellitus.   "
50209|NCT02628379|"     The goal of the current study is to determine whether Foundation Medicine's next generation     sequencing assay, called FoundationOne, will provide information that allows physicians to     make treatment decisions using targeted therapies in clinical trials or FDA approved     therapies, including off-label agents, that result in superior OS compared to historical     outcomes for standard CUP therapy.   "
50210|NCT02628366|"     People with failed kidneys need an artificial kidney machine (called dialysis) to remove     toxins and extra fluid from the body. Most patients receive dialysis treatments at a hospital     three times a week. During treatment, a patient's blood pressure may drop, causing dizziness     and muscle cramping. Repeated drops in blood pressure can also injure the heart and brain.     Over time, this can lead to heart attacks, strokes, and sometimes death. New research shows     that cooling the temperature of the dialysis fluid (called dialysate) can reduce heart and     brain injury. In most hospitals, all patients' dialysate temperature is set at 36.5 ºC (to     match body temperature). In our study of 73 patients, we showed that reducing the dialysate     temperature to 0.5 ºC below body temperature protected the heart and brain from injury [1,2].     We now want to test this simple, safe, low-cost intervention in a large study with more than     7000 dialysis patients in Ontario. We can lower the dialysate temperature on dialysis     machines in Ontario at no added cost. This intervention has the potential to reduce many     hospitalizations and deaths in Ontario, and relieve suffering in patients with kidney     failure.   "
50211|NCT02628353|"     The study's main objective is to investigate the effects of acute consumption of a     preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on     systolic BP after ingestion of a high fat meal.   "
50212|NCT02628340|"     HIV infection can be efficiently controlled by antiretroviral therapy (ART), with in 2013     nearly 85 % of patients having a suppressed viremia, but HIV cannot, however, be eradicated     with ART alone [1]. Overall, HIV has moved from a fatal to a chronic disease provided     treatment is maintained life-long. Despite major improvement in antiretroviral drugs in terms     of efficacy, tolerability and simplicity, life-long therapy is still associated with drug     toxicity. Several drugs or drug classes, which have historically saved lives since 1996 and     are currently widely used such as protease inhibitors and nucleosides analogues, are     associated with long-term toxicities and increased incidence of comorbidities.      Currently, worldwide there is an approximated 10 millions of HIV infected patients under     cART. This number should increase in the next years, as most recent guidelines recommend     earlier therapy given the benefits in terms of disease progression and prevention of     transmission. Because of the increasing number of patients who will be under cART in the     future, the cumulative ART toxicity, the difficulties to access ART in some areas of the     world, the fatigue expressed by patients about ART and the cost issues, there is an urgent     need to search for HIV CURE. To date, only two cases of sterilizing HIV cure were reported so     far: the famous Berlin Patient after two homozygous Delta32-CCR5 bone-marrow grafts for an     acute leukemia [2], and the Mississipi baby after very early initiation of cART 31 hours     after delivery [3]. However those cases of sterilizing HIV cure remain exceptional and the     alternative objective of a functional HIV cure appears to be more realistic, though still     described in rare groups of patients like Elite controllers (EC) and post treatment     controllers (PTC) patients. In addition new and complex therapeutic strategies are currently     proposed to try purging the HIV reservoirs, but none of them proved so far able to reach this     goal.      Therefore the objective of finding a Cure to HIV [4] requires first to better understand the     basic mechanisms of the persistence of HIV reservoirs in the population of     chronically-infected fully-suppressed HIV+ patients in order to define future therapeutic     strategies.   "
50213|NCT02628327|"     1. To administer a questionnaire to patients seen by Wills Eye Glaucoma Department          physicians at Wills Eye Hospital assessing satisfaction with their office visit, vision          related quality of life, and related issues.        2. To collect and de-identify information from each participant's medical chart related to          their care including information pertaining to demographics, disease severity, and prior          and current treatment        3. To assess the correlations between demographic factors, vision related quality of life,          eye disease, and treatments with patient satisfaction survey responses.   "
50214|NCT02628314|"     The purpose of this research study is to test whether researchers can reliably measure the     response pupils have when an acute painful stimulus is experienced. Changes in the size of     the pupil of the eye can be an indicator of brain activity in a region of the brain that is     important for feeling pain.   "
54618|NCT02570711|"     To evaluate the Safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects     with metastatic pancreatic cancer using standard response criteria   "
50238|NCT02628002|"     This study will test the hypothesis that the anti-gravity treadmill can be safely used in     stress nuclear myocardial perfusion imaging in patients unable to perform conventional     treadmill exercise.      This will be foundational evidence on which to consider a larger clinical trial to show that     the anti-gravity treadmill improves diagnostic specificity across all cardiovascular stress     testing modalities including treadmill-alone, exercise stress echocardiogram, exercise SPECT     as well as having implications for cardiac PET and MRI in the future.   "
50217|NCT02628275|"     Subclinical atherosclerosis is identified in roughly 2/3rd of otherwise healthy young adults.     How much physical activity is required to prevent progression of subclinical atherosclerosis?     In the 85% of healthy younger Canadian men and women who do NOT perform the recommended 150     min/week of moderate- to vigorous-intensity physical activity (MVPA) as recommended, is it     reasonable to aim for a lower regimen of light physical activity (LPA) despite the absence of     supporting literature, or to the contrary should the investigators insist on achieving MVPA?     In this perspective, MoMA provides a unique opportunity to determine whether LPA vs. MVPA is     necessary to limit subclinical atherosclerosis progression in inactive otherwise healthy     adults. Resolving such unknowns should inform strategies to prevent decades of silent disease     progression leading to future morbidity and mortality.   "
50218|NCT02628262|"     Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients     with macular hole. Investigators investigate the association between FAF and visual acuity,     recovery of foveal microstructure, and FAF in surgically closed macular holes.   "
50219|NCT02628249|"     Protein requirements in individuals who participate in endurance-based exercise training have     been suggested to be greater than the current recommended dietary allowance (RDA).      The biological value of protein depends on the amino acid composition. As liebig's law of the     minimum, the protein synthesis is limited due to the lack of single rate limiting amino acid.     In this case, the first rate limiting amino acid determines protein intakes to maximize the     protein synthesis. Adding a small amount of rate-limiting amino acid to the diet improves the     biological value of its protein diet.      The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid     requirement in children, normal healthy adult and clinical populations. however, the IAAO     method has never been utilized for determining the first rate limiting amino acid.      Therefore, the purpose of this study is to address of IAAO method to be applied for     determining the rate-limiting amino acid in endurance athlete.   "
50220|NCT02628236|"     The purpose of this study is to evaluate the potential for systemic exposure of     aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under     occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK)     involving the upper extremities.   "
50221|NCT02628223|"     Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in     treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and     studies at academic centers have shown mixed results when comparing the success rates of 180     degrees or 360 degrees. Both protocols are now typically done by comprehensive     ophthalmologists. However, there is no data that compares success rates of 180 degrees and     360 degrees in the community setting.   "
50222|NCT02628210|"     This is a single-arm post-market study in patients requiring lumbar fusion using allograft     interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with     degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10     sites. After subjects have signed an informed consent, the baseline visit and examinations     will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and     24 month visit after surgery.   "
50223|NCT02628197|"     The purpose of this interventional study was to investigate the impact of control of systemic     inflammation by scaling and root planing (SRP) on bone mineral density (BMD) in osteopenic     post-menopausal women with Chronic periodontitis(CP). Out of 68 osteopenic postmenopausal     women with CP, 34 participants each were included in test and control group. BMD, hsCRP and     periodontal parameters were recorded at baseline and 6 months.   "
50224|NCT02628184|"     BACKGROUND: In 2011 a Maternity Services Development Programme was implemented in a South of     England city, to promote effective collaborative working between maternity services     (midwives) and other service providers (health visitors, social workers, specialist services     etc.) by co-locating services in local childrens centres. The progamme ultimately aimed to     improve care for local service users (women and their families), especially those considered     vulnerable. Implemented changes were based on evidence that suggests poor collaborative     working contributes to poorer outcomes. RATIONALE: To explore the impact of the programme on     local service providers, and by association service user care. AIM: To explore a localised     Maternity Services Development Programme, identifying how inter- agency collaborative working     occurs, and the service providers perceived benefits and challenges on collaboration, and by     association service user care. METHODOLOGY: The proposed research uses a case study approach     to collect and analyse predominantly qualitative data, and some quantitative data. Data will     be collected using observation episodes (e.g. participant meetings) to observe collaboration,     and interviews to explore these experiences. Additionally documents will be analysed to     observe documented evidence of collaborative practice. Pre-existing statistical data will     also be used to highlight changes in indicators of service user well being since the     implementation of the Maternity Services Development Programme. PARTICIPANTS: A cross-section     of service providers (no service users) working in or with maternity services from 4 of 9     city Children Centre's. FINDINGS: No current findings, data collection expected to start     September 2015.   "
50225|NCT02628171|"     This study evaluates the effect of cashew nut consumption on traditional and emerging markers     of cardiovascular disease (CVD) risk and determines the usable energy content of a serving of     cashew nuts for accurate food labelling.   "
50226|NCT02628158|"     Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal     pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators     evaluate whether presence of FAF may correlate to the postoperative visual outcome for     epiretinal membrane.   "
50227|NCT02628145|"     This is a randomized clinical trial with a control group that will test how periodized     resistance training will impact measures of sarcopenia in older women who have been     identified as presarcopenic or sarcopenic. The intervention will be approximately 12 weeks in     duration with 24 total free-living older women. Outcome measures will be collected at     baseline, 6 weeks and post-intervention.   "
50318|NCT02626962|"     This is a Phase 2, single-arm study of nivolumab combined with ipilimumab in subjects with     previously untreated, unresectable or metastatic uveal melanoma. Previous studies with     immunotherapy have shown promising results and this synergistic combination was very     effective in other tumors. This study will allow for further characterization of the safety     and clinical activity of nivolumab combined with ipilimumab in subjects with uveal melanoma.   "
50228|NCT02628132|"     The expression of PD-L1 in breast cancer has been previously demonstrated (Ghebeh et al     2006). In addition, PD-L1 has been shown to work as a molecular shield, by protecting     cancer cells from cytotoxic T-cells and chemotherapy induced apoptosis (Ghebeh et al 2008)     suggesting to combine PD-L1 blockade with chemotherapy.      This trial will test Durvalumab in combination with Paclitaxel on metastatic triple-negative     breast cancer patients. The safety profile of Durvalumab as a monotherapy has been previously     established (lu et al 2015). In this trial the safety profile and tolerability of Durvalumab     given in combination of Paclitaxel will be tested. In addition, the efficacy of this     combination on metastatic breast cancer will be monitored.   "
50229|NCT02628119|"     Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in     significant clinical morbidity in patients with End Stage Renal Disease (ESRD), causing a     severe economic burden on any health care system. Arteriovenous (A-V) dialysis accesses are     the preferred form of permanent dialysis access as compared to central venous catheters (CVC)     . One of the reasons for CVC use is poor long term patency rates of A-V access. Arteriovenous     Grafts (AVG) have a primary patency rates of just under 50% at 12 months and around 33% at 18     months. Native arteriovenous fistula (AVF) are slightly better with primary patency rates of     around 60 percent at one year and 51 percent at 2 years. The most common cause for AVF and     AVG dysfunction is stenosis development due to neointimal hyperplasia (NIH) within the     circuit leading to access thrombosis. Percutaneous transluminal angioplasty (PTA) is the     current standard of treatment for these lesions. Despite being the treatment of choice for     these lesions patency rates after PTA continue to be dismal. One of the problems with poor     long term outcomes after successful intervention is how you assess immediate intervention     success. Successful angioplasty is defined by Dialysis Outcome Quality Initiative (DOQI)     guidelines as one where only less than 30% residual stenosis remains at the end of     intervention. Unfortunately angiographic images post angioplasty correlate poorly with     improvement of access flows through the arteriovenous circuit. There are two main problems     with these practice standards. First, they are based on a 2-dimensional angiographic view of     the lesion which may be misleading. Secondly, this assessment of recoil is very subjective     and not base on objective data.      Access flow monitoring can now be performed intra-procedurally with thermal dilution     technique. Its benefit was shown in a small pilot study. To date there have not been any     randomized controlled trials to assess the benefit of such an approach where intervention is     based on improvements in access flow at the time of intervention. We hypothesize that such an     approach will improve outcomes after interventions related to access dysfunction. This may     also identify the right scenarios in which stent placement may benefit thus improving     outcomes after stent placement as well.   "
50230|NCT02628106|"     The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on     renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent     magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were     included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without     diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1     intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and     after lipo-PGE1 administration to acquire bilateral renal cortical R2*(CR2*) and medullary     R2* (MR2*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including     24 hours urinary protein and serum creatinine were collected. the investigators want to prove     Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.   "
50231|NCT02628093|"     Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects     undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the     instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2      - Ligasure Population   "
50232|NCT02628080|"     Solid tumours often have highly disorganised vasculature that results in low oxygenation.     This combined with high metabolic rates leads to oxygen demand outstripping supply causing     tumour hypoxia. Hypoxia drives multiple cellular processes involved in the hallmarks of     cancer. Tumour hypoxia also decreases the effectiveness of anticancer treatments. This is     especially true for patients treated with radiotherapy since it has been long recognised that     hypoxic tumour cells require 3 times the dose of radiation to cause the same amount of cell     death as cells irradiated under normal oxygen conditions.      To date, the majority of attempts at overcoming tumour hypoxia have focused on increasing     oxygen supply. However, such techniques have produced modest benefits at best and     subsequently have not been adopted into current clinical practice.      An interesting alternative approach to tackling tumour hypoxia is to decrease oxygen 'demand'     by reducing tumour oxygen consumption. This strategy has been suggested to be more effective     in reducing hypoxia than previous methods aimed at increasing oxygen delivery.      Pre-clinical data demonstrates that the commonly prescribed anti-protozoal drug atovaquone     significantly reduces oxygen consumption in a variety of tumour cell lines in vitro. This     reduction in oxygen consumption leads to a profound reduction in tumour hypoxia in animal     models. It is anticipated that if these effects on tumour hypoxia could be reproduced in     humans, that their tumours could be rendered markedly more sensitive to radiotherapy.      This window of opportunity trial will assess whether atovaquone significantly reduces tumour     hypoxia in adult patients referred for surgery with suspected non-small cell lung cancer.     This will be assessed using a combination of functional imaging and circulating markers of     hypoxia. If atovaquone is demonstrated to result in a reduction in tumour hypoxia, larger     clinical trials will be conducted to determine whether this well-tolerated and inexpensive     agent improves radiotherapy efficacy and clinical outcomes.   "
50234|NCT02628054|"     Research studies have found a relationship between the immune system (how the body reacts to     an infection) and the development of depression. As it is still unclear how they might be     linked the investigators will use a typhoid vaccination to activate the body's immune system     and will measure the response by looking at changes in sleep patterns.   "
50235|NCT02628041|"     High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to     Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as     90-100% for favorable prostate cancer at a median follow-up of 3-5 years.      HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup     errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB     causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can     lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and     Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and     increased psychological distress.      The goal of the investigators' phase II randomized study is to evaluate the differences in     QOL in the urinary domain between patients with favourable intermediate risk or extensive     low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate     Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since     HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary     objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom     Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess     local control.   "
50236|NCT02628028|"     The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in     adults with rheumatoid arthritis (RA).   "
50237|NCT02628015|"     This study tests preschoolers, school children, youths and young adults, who were born     preterm or full-term, in their theory of mind abilities.   "
50355|NCT02626468|"     Validation of Structured Light Plethysmography (SLP) in patients with conditions such as     Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy     participants.   "
50240|NCT02627976|"     A common complication of breast conserving therapy is breast edema, which may lead to chronic     pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present     most patients are currently treated with physical therapy, but evidence of its effectiveness     is still low and a gold standard does not yet exist. A downside of physical therapy is that     patients have to undergo the therapy regularly and treatment might even has to continue for     years after symptoms and treatment started. Another treatment option is a compression vest     with the potential, apart from reducing symptoms, to improve self-efficacy in patients     because they decide when to wear it without the need to visit therapists. However     effectiveness of the compression vest has not yet been objectified in studies.      The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of     breast edema of wearing a compression vest, in order to determine whether a large randomized     study is feasible.   "
50241|NCT02627963|"     This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center,     parallel-arm study comparing tivozanib to sorafenib in subjects with refractory advanced     renal cell carcinoma (RCC).      Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib.      Subjects will be stratified by International Metastatic Renal Cell Carcinoma Database     Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior     vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior     checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L)     inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).      All subjects will be evaluated for progression free survival, overall survival, objective     response rate, and the duration of response as well as safety and tolerability.      Pharmacokinetic (PK) analysis are also included in study.   "
50242|NCT02627950|"     The current prospective, randomized, controlled MonAMI trial aims to systematically examine     the effects of morphine on the platelet inhibitory effects of the orally administered     platelet inhibitor ticagrelor in patients with acute myocardial infarction. In addition, the     potential positive or negative effects of MCP in combination with morphine on platelet     inhibition will be studied.   "
50243|NCT02627937|"     The purpose of this study is to develop adequate and satisfactory tools using reliable     clinical and physical factors in predicting pediatric obstructive sleep apnea/hypopnea     syndrome (OSAHS) and allow greater access to appropriate therapy in children.   "
50244|NCT02627924|"     The study is designed as a prospective, observational study to assess the effect of     adalimumab on health-related quality of life (QoL) and work productivity in patients with     rheumatoid arthritis (RA) in Korea   "
50245|NCT02627911|"     The study will be conducted in crossover trial, with two 72-hour hospitalization separated by     a period Wash-out of at least one week. Each hospitalization is a period of treatment.     According to randomization, patients will be provided with either Diabeloop system or the     usual system.      In both treatment periods:        -  patients in a situation of sedentarity or physical activity, will be equipped with          ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate)        -  meals and physical activities will be similar in both periods        -  the same blood glucose meter will be used throughout the duration of the study.        -  the capillary blood glucose will be performed : before bolus and 2 hours after a meal,          before exercise, in case of hypo or hyper-glycemic episodes and when the patient and /          or investigator deem it necessary.   "
50246|NCT02627898|"     Type 2 diabetes mellitus (T2DM) has become the epidemic of the XXI century. This chronic     disease is also highly prevalent and primarily associated with an increased cardiovascular     mortality and morbidity due to micro and macrovascular complications, where its     pathophysiological mechanism accelerates the formation of the atherosclerotic process,     fundamental element associated with arterial stiffness. The importance of anticipating the     presence of a cardiovascular event lies precisely in the early detection of subclinical     changes in the elastic arteries identified by measuring the pulse wave velocity. Having     adequate pharmacological or non-pharmacological interventions that impact precisely in the     reduction of pulse wave velocity contributes to a reduction of cardiovascular morbidity and     mortality associated with DM2. Among non-pharmacological therapies they have been studied the     benefits attributed to the use of green tea infusion either encapsulated or extract have been     associated mainly with anti-inflammatory and antioxidant effects. There are both experimental     and clinical studies that have shown benefits of administration of green tea (extract or     infusion), and administered by different routes at different dosages and for varying times.     But it has been noted that not all studies with green tea meet appropriate to draw     conclusions about its benefits to cardiovascular level. However, it is proposed that the use     of green tea extract with a highest amount of catechins through a controlled clinical trial     could be a potential therapeutic strategy for changing hemodynamic alterations and arterial     stiffness favorably in this particular group of patients DM2.   "
50247|NCT02627885|"     The aim of the study is to investigate if an Internet-based psychological treatment based on     principles from Cognitive Behavioral Therapy can increase function and quality of life for     patients with Parkinson disease.   "
50248|NCT02627872|"     Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which     primarily increases among the female population. The purpose of this study is to perform     in-depth clinical and molecular characterizations of early stage COPD patients, as well as     healthy never-smoker and at-risk smoking control populations to identify molecularly related     subgroups patients, including gender-related sub-phenotypes of COPD.   "
50249|NCT02627859|"     26 week open label study of treatment with Durolane for OA pain of the ankle   "
50252|NCT02627820|"     ATTRwt (also known as senile systemic, or senile cardiac amyloidosis) is a progressive heart     disease, causing congestive heart failure. It is caused by amyloid protein deposits in the     heart, that are derived from a normal protein, TTR, made in the liver. The aim of the study     is to determine whether lowering the blood levels of TTR, by a weekly injection of a compound     designed specifically to do this, will slow the progression of the disease when treated     patients are compared to previously-followed patients who were not receiving this drug. The     study also aims to determine how well this drug is tolerated and the existence and severity     of any drug side-effects.   "
50364|NCT02626351|"     This study evaluates the impact of a quality improvement (QI) intervention on maternal and     child healthcare services in seven primary healthcare (PHC) clinics, in a rural setting of     KwaZulu-Natal, South Africa.   "
50254|NCT02627794|"     Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic     rhinosinusitis that is not adequately controlled with maximal medical therapy.      In some patients, underlying inflammation (discharge, edema and polyposis), compounded by     inflammation caused by surgical trauma may lead to an uncontrolled healing response, which     results in the synechiae formation in the middle meatus (MM).      Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of     middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic     visualization of the sinus cavities postoperatively. This may result in difficulty in     performing postoperative routine endoscopic debridement and examination, which is paramount     to a successful outcome from ESS. Spacers are often inserted during surgery between nasal     mucosal surfaces to prevent synechiae.      The aim of this study is to see if a steroid-impregnated spacer is more effective at reducing     inflammation after sinus surgery than a Silastic spacer.   "
50255|NCT02627781|"     The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high     incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to     negative appendectomies. The aim of the present observation study is to evaluate a diagnostic     and therapeutic algorithm for suspected acute appendicitis.      The investigators believe that this diagnostic algorithm helps to simultaneously avoid     unnecessary operations, costs and radiation exposure.   "
50256|NCT02627768|"     The purpose of this study is to evaluate treatment retention in psoriatic arthritis     participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in     relation to effectiveness, safety, benefit/risk and to examine clinical response.   "
50257|NCT02627755|"     The use in a combined way of two systems of intubation (Glidescope + aScope) would condition     an increase in the success rate of endotracheal intubation maneuver compared to conventional     isolated Glidescope use in patients with clinical criteria of difficult airway.   "
50258|NCT02627742|"     To determine if a therapy regimen including treatment with The MetaNeb® System has a positive     impact on the rate of pulmonary complications that occur in high risk post-operative     patients. This is a non-randomized facility (or hospital) level pre-post intervention study.   "
50259|NCT02627729|"     Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal     cancer patients treated with laparoscopic hand-assisted low anterior resection   "
50260|NCT02627716|"     The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance     directive which involves the patient, the healthcare team, their relatives and a third party     caregiver as intermediary for the project.      The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the     reduction in hospitalisations within 18 months of its development by comparison to the     standard psychiatric care.      Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months     and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.      Single blind multicentre randomised trial with parallel control groups.      Effectiveness study of a psychiatric care strategy.   "
50261|NCT02627703|"     This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay     on the decision making of the treating physician and the patient. The Oncotype DX® assay is a     commercially available diagnostic test that aids in a physician's treatment recommendation to     a breast cancer patient. The study also has a pharmacoeconomic component.   "
50262|NCT02627690|"     Islet transplantation for type 1 diabetes results are still improving, and actually     Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of     c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological     interventions to inject islets, an immunosuppressive regimen is needed, which can be     deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet     transplantation on stabilization or prevention of macro and micro vascular complications of     diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or     improvement of microvascular complications when compared to pre-transplant datas.      The aim of this study is to compare the evolution of diabetes complications, especially     nephrologic, 10 years after islet transplantation and to compare it to patients with a     brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed.      This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine     clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of     type 1 diabetes) before islet transplantation and 10 years after the transplantation or after     the first evaluation in patients who finally did not underwent islet transplantation for     various non nephrologic reasons   "
50263|NCT02627677|"     The purpose of this study is to compare the efficacy and safety of 2 starting doses of     ponatinib compared to nilotinib in patients with imatinib-resistant chronic myeloid leukemia     (CML) in chronic phase (CP).   "
50264|NCT02627664|"     The investigators prospectively enrolled 64 early PD patients (less than 3 years after the     first symptom) in order to prospectively assess the natural history of non-dopaminergic     symptoms.   "
50300|NCT02627196|"     The purpose of this trial is to develop valid scientific evidence for safety and     effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in subjects     with heart failure, defined as New York Heart Association (NYHA) functional class III and     left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate     heart failure guideline directed therapy, excluding subjects eligible for or actively     receiving Cardiac Resynchronization Therapy (CRT).   "
50265|NCT02627651|"     18 children post acquired brain injury and 18 typically developed controls matched for age     and gender.      All children aged 10-18 yrs who understand simple commands.      Tools:        1. Heart rate monitor        2. Six minute walk test        3. The behavior rating inventory      Method:        1. At the introductory visit the child will be asked to walk for six minutes, to sit and          perform a cognitive test and then to walk on a treadmill for 5 seconds.        2. At the second visit the child will be asked to go on the treadmill for 5 minutes and at          the same time to perform the cognitive assignment; After a rest the child will be asked          to walk on the treadmill for 5 minutes and at the end to perform the cognitive          assignment .   "
50365|NCT02626338|"     The proposed study is designed to combine crenolanib with standard salvage chemotherapy to     treat patients with R/R AML irrespective the FLT3 status.   "
50266|NCT02627638|"     For more than seven years an osteopath has been working in the palliative care unit (PCU) and     in both palliative care mobile team (PCMT) as a member of the multidisciplinary team. The     patients referred to the osteopath by the palliative care physicians present pains related to     cancer, but also to the treatment, in particular to surgery or radiotherapy. The osteopath     can help with other symptoms such as constipation or dyspnoea. As this approach is provided     in complement of the medicinal approach, it is not considered as an alternative medicine but     as a complementary medicine associated to a conventional care. It seemed relevant to the     investigators to ask the cancer patients undergoing osteopathic sessions for pain how they     saw this complementary therapy.   "
50267|NCT02627625|"     The purpose of this study is to compare the absorption of three different inhalation products     with the reference products in healthy volunteers.   "
50268|NCT02627612|"     Some Veterans who recently served in the military report significant psychological problems     based on their experiences in the military. Stressors that these Veterans face when they     transition out of the military can acerbate these problems and negatively impact their     long-term physical and psychological well-being. The investigators are conducting a     randomized controlled trial to evaluate the efficacy of providing Veterans who are     transitioning back into their civilian communities trained, peer mentorship (Pro Vetus) and     membership in a Veteran Support Organization (VSO) Team Red, White, and Blue (TM RWB) to     reduce transition stressors, maintain psychological and physical health, reduce suicides and     reduce criminal incidents.   "
50269|NCT02627599|"     -  Evaluate subjects in an prospective observational study        -  Subjects will be administered scientifically validated questionnaires        -  Evaluate Quality Improvement and Oxygen Utilization Improvements.           1. Functional capability, dyspnea, oxygen saturation as primary endpoints             1. Baseline Dyspnea Index (BDI)             2. Transitional Dyspnea Index (TDI)             3. Chronic Respiratory Disease Questionnaire (CRQ)             4. Six minute walk distance (6MWD)             5. Oxygen saturation using pulse oximeter        -  The secondary endpoints:             1. Portable oxygen source utilization             2. Health care utilization (emergency room encounters, hospital admissions)   "
50270|NCT02627586|"     Several studies have shown that high-intensity interval training (HIIT) is more effective     than moderate-intensity continuous exercise training (MICE) at improving functional capacity     and quality of life in stable cardiac patients and can be performed safely.      However, its effect on patients after recent myocardial infarction is currently unknown. In     these patients avoidance of a negative remodeling after an acute myocardial infarction is of     upmost importance. Therefore, assessment of the influence of HIIT on post-infarct left     ventricular-remodeling is urgently needed.      Therefore, the aim of this study is to determine the effect of HIIT on left ventricular (LV)     remodeling (measured by LV end diastolic volume) compared to the effect of the more     established MICE training modality.      Further measurements include other parameters of LV remodeling (LV contractility, and brain     natriuretic peptide), prognostic parameters (peak oxygen uptake, exercise capacity), cardiac     output, endothelial function, leg muscle function and scores of quality of life. Further,     certain blood parameters and heart rate variability measured by electro-cardiogram are     measured to assess the safety of this type of training.      Patients with first ST-segment elevation myocardial infarction (STEMI) or equivalent with     onset of symptoms of ischemia and treated by primary percutaneous intervention within the     preceding 4 weeks will be included.      The HIIT and MICE is integrated in a 12-week exercise training program at the Inselspital     Bern, consisting of 1) exercise training, 2) nutrition counselling and 3) psychotherapy. The     exercise program will comprise 3 weekly exercise sessions lasting 90 minutes, supervised by     experienced exercise therapists. The program focuses on endurance type exercises,     strengthening and relaxation exercises as well as exercises to improve coordination skills.     In the first 3 weeks (run-in-phase), all patients will complete three weekly MICE sessions.     In the following 9 weeks, patients randomized to the intervention group will perform two     weekly HIIT sessions and one MICE session per week. The control group will continue with     three weekly MICE sessions for the 9 week intervention phase.      A total of 144 patients will be recruited. Measurements will be performed at baseline, after     a 3-week run-in-phase, and after the 9-week intervention phase. Safety measurements will be     performed during the 4th and 12th week.   "
50271|NCT02627573|"     Purpose There is a growing evidence of high efficacy of post-transplantation cyclophocphomide     (PTCy)-based GVHD prophylaxis in haploidentical and matched related and unrelated bone marrow     transplantation. There is limitted, but growing data on safety and efficacy of this     prophylaxis in unrelated and peripheral blood stem cell transplantations. Use of PTCy in     chronic myeloproliferative neoplasms and myelodisplatic syndrome is of particular interest.     On the one hand, PTCy could reduce the incidence of chronic GVHD and long-term bormidity. On     the other hand, there is a concern, that PTCy can increase the incidence of graft failures in     this group of patients. Currently published data indicate that low-dose Thymoglobulin-based     prophylaxis is the most promissing compatitor in terms of acute and chronic GVHD control. So     there is a rationale to randomize Thymoglobulin and PTCy as GVHD prophilaxis. Pre-transplant     assesment of moratlity (PAM)-index will be used as the strata for randomization, as it is the     paramter that takes into account the most important factors effecting survival. The     conditioning regimen and the other two components of GVHD prophylaxis (mycophenolate mofetil     and tacrolimus) will be identical in the two arms of the study.   "
50272|NCT02627560|"     After surgical procedures, interventions to reduce postoperative bleeding are of great     importance. In this study, the effect will be investigated of smearing tranexamic acid, which     is designed for injection, directly onto the raw wound surface (topical application) created     during surgery. Topical application allows a small amount of drug to reach a large wound     area, higher drug concentration in the exposed wound surface but very low concentration in     the body, and no risk of injury from needles. The researchers have recently shown that     topically applicated tranexamic acid reduces bleeding in women who had two-sided breast     reduction surgery. Now it will be studied whether topically applicated tranexamic acid     reduces bleeding after breast surgery for breast cancer.      After surgery for breast cancer patients may also experience problems with long lasting     seroma. Therefore it will at the same time be investigated whether topical tranexamic acid     reduces the development of seroma in these patients.   "
50432|NCT02625467|"     The purpose of this study is to evaluate the visual results of patients with keratoconus     treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer     laser assisted lamellar keratoplasty (PALK).   "
50352|NCT02626507|"     This is a dose-escalation Phase Ib clinical trial in 18 patients with newly diagnosed Stage     I-IV ER+/HER2- breast cancer, with the primary cancer in place. These patients have not     received prior therapy for their breast cancer and intend to undergo surgery after four     cycles of therapy.      This is an open-label study, and investigators and subjects are not blinded to the treatment.     The reason for using an open-label study design is because this is a dose-escalation trial,     and the investigators need to determine the potential toxicity before a decision can be made     to continue the dose escalation procedures.      The assignment of patients will not be randomized, as this is a dose-escalation trial.   "
50273|NCT02627547|"     Flavonoids are compounds that have been proven to have a beneficial effect on health, such as     reducing the risk of developing cardiovascular disease and, in some cases, cancer. Citrus     juices have a high flavonoid content. However, the absorption of flavonoids into the body is     limited. This study will investigate whether being physically active improves the absorption     of flavonoids.      Endurance trained athletes will be invited to participate. Following screening procedures (a.     Health Screening Questionnaire; b. height and weight measurement for calculation of Body Mass     Index; c. maximal oxygen consumption (VO2max) uptake test, eligible participants will     undertake two experimental tests; one during a period of normal training, the other     immediately following 1 week of detraining.      In the morning of the experimental trial participants will consume 500 mL of orange juice.     Blood samples and urinary fractions will be collected prior (base line) to and for 24 hours     after orange juice consumption. Participants will be asked to follow a special     polyphenol-free diet and record weighed dietary intake for 2 days preceding each trial and     during the day of the experimental trial.      The study aims to:        1. Determine the effects of training status of endurance athletes on bioavailability of          flavanones in endurance trained individuals        2. Determine whether changes in bioavailability of flavanones are related to changes in          biomarkers of inflammation, oxidative stress, plasma lipids and insulin sensitivity.   "
50274|NCT02627534|"     Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This     close relationship between both diseases is characterized by mutual influence. The presence     of DM might impair prognosis of diverse dental treatments due to its inflammatory nature,     negative influence on wound healing, on bone biology, and the establishment of infections.     Consequently, knowledge of new dental therapies and the biology of dental treatments for     chronic periodontitis in diabetic patients can enhance quality of life and make these     treatments more adequate for this common profile of patients.   "
50275|NCT02627521|"     The administration of Ticagrelor have demonstrated superiority to Clopidogrel in patients     presenting with acute coronary syndrome (ACS) and remains a first line therapy as an adjunct     to aspirin for patients admitted with ACS. The patient population treated with Ticagrelor at     an early time point includes non ST elevation myocardial (NSTEMI) patients and those     undergoing primary angioplasty for ST elevation myocardial infarction (STEMI). It is     estimated that 10-15% of patients presenting with ACS have advanced coronary artery disease     requiring Coronary Artery Bypass Surgery (CABG). The treatment guidelines recommend a delay     of 5-7 days for CABG surgery in these patients for normalization of Ticagrelor induced     platelet inhibition to reduce the risk of peri-operative bleeding. This delay may expose     these high risk patients to adverse cardiac events while waiting for Ticagrelor effect to     wean off. Furthermore, this empirical application of 5-7 day delay in all patients may be     unnecessary due to the significant inter individual variability in response to Ticagrelor.     There is limited data to determine the optimum timing of CABG surgery in ACS patients treated     with Ticagrelor. The present study will determine the optimum timing of CABG in ACS patients     treated with a loading and/or maintenance dose of Ticagrelor.   "
50277|NCT02627495|"     This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on     Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study     design.   "
50278|NCT02627482|"     Most babies who measure small during pregnancy are born healthy. However, some are small     because they are not growing as expected, usually because the placenta (the baby's 'life     support' system) is not working properly. These babies are at greatly increased risk of dying     before birth, and need to be delivered before they become poorly.      Scans and electronic heartrate monitoring are currently used to monitor these babies. But     they can only be used for short periods and don't always provide enough information to show     when to deliver the baby.      A small light monitor has been developed that safely records the baby's heart rate for up to     16hrs by measuring electrical activity through sticky patches on the mum's skin (like a     normal ECG). The woman carries on with her daily activities while wearing it. Monitoring the     heart rate over a longer time may help with decisions about the timing of the delivery and     could prevent stillbirth, the aim of our future study. This will include large numbers of     women carrying small babies. Before the investigators can do this the investigators need to     know whether:        1. Wearing the monitor for 16hrs is practical and acceptable to pregnant women        2. The monitor can provide useful information on the baby's heart rate at different stages          of pregnancy.      Thirty pregnant women whose babies are measuring small will be asked to wear the monitor on     two occasions, for 16hrs each time. The women will describe what they think about wearing the     monitor by completing questionnaires.      The data from the monitor will be downloaded and compared with the woman's medical notes     after the participant has delivered her baby. Results from this study will be publicised and     will help with the design of the investigators future study into the usefulness of this     monitor.   "
50279|NCT02627469|"     Objective: The effect of weekly professional oral care on the composition of the oral flora     in dentate, dependent elderly residents was followed during a 12-month period.      Background: Long-term, regular professional oral hygiene care reduces the total number of     microorganisms and oral disease-related microorganisms. Less is known about the effect on the     quality/composition of the remaining oral flora.      Materials and methods: Thirty-three subjects were included in the study group and 35 in the     control group. Dental status, presence of supragingival-plaque, labial minor gland secretion     rate, and prescription medicines were recorded. Microbial samples, collected from     supragingival plaque and the dorsum of the tongue, were analyzed using cultivation technique.   "
50861|NCT02619864|"     The standard or usual treatment for this disease is standard chemotherapy alone. For the     first part of this study (phase I), there are two purposes. The first is to see whether     AZD2014 can affect glioblastoma multiforme, and the second purpose is to see what effects it     has.   "
50353|NCT02626494|"     This study aims at testing for the impact of glutamatergic changes on drug craving in cocaine     addiction, and to evaluate the effects of n-acetylcysteine (n-AC) on both glutamate     homeostasis and craving using a randomized, double-blind, placebo controlled cross-over     design.   "
50401|NCT02625870|"     The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl     Esters 90 Soft Capsules and placebo. The primary objective of the present study was to     evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects     with severe hypertriglyceridemia (TGs ≥500 mg/dL but ＜2000 mg/dL).   "
50280|NCT02627456|"     Background:      Malaria is still a health problem in Sub-Saharan Africa. Death rates are stable and have even     increased in some areas. There are malaria vaccines. However, researchers think repeated     immunizations with a vaccine called PfSPZ may work better.      Objective:      To see if PfSPZ is safe, tolerable, and effective against malaria.      Eligibility:      Healthy adults ages 18 to 50 years who live in the Doneguebougou area in Mali      Design:      Participants will be screened with medical history and physical exam.      Participants will sign or fingerprint the consent form. They will take a survey to see how     well they understand the study.      Participants will give blood and urine samples.      Participants will have at least one ECG: Soft electrodes will be stuck to the skin. A machine     will record heart signals.      Participants will have HIV counseling.      Participants will be assigned to a group. Groups will get a different strength doses. Groups     will get a different number of vaccines over different periods of time.      If a participant develops a rash or injection site reaction, photographs may be taken.      Participants will receive an oral anti-malaria drug during the study.      Participants will be monitored for 3 to 6 months after the last vaccine.   "
50281|NCT02627443|"     This randomized phase I/II trial studies the side effects and how well carboplatin and     gemcitabine hydrochloride with or without ATR kinase inhibitor VX-970 work in treating     patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back     (recurrent) and has spread to other places in the body (metastatic). Drugs used in     chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and     gemcitabine with or without ATR kinase inhibitor VX-970 may work better in treating ovarian,     primary peritoneal, or fallopian tube cancer.   "
50282|NCT02627430|"     This phase I trial studies the side effects and best dose of talazoparib and heat shock     protein (HSP)90 inhibitor AT13387 when given together in treating patients with solid tumors     that have spread to other places in the body (metastatic) or ovarian, fallopian tube, primary     peritoneal, or hormone negative breast cancer that have come back after a period of     improvement (recurrent). Talazoparib and HSp90 inhibitor AT13387 may stop the growth of tumor     cells by blocking some enzymes that are need for cell growth. HSp90 inhibitor AT1338 may also     help talazoparib work better by making tumor cells more sensitive to the drug.   "
50283|NCT02627417|"     Due to its expected efficacy based on the retrospective data available in ITP, its relatively     good safety profile and its very low cost , dapsone could be a good steroid-sparing     second-line option for adults with ITP.      This study is a phase III prospective multicenter randomized open trial comparing two     treatment strategies:        -  Arm A (experimental arm): prednisone at 1 mg/kg for 3 weeks + dapsone at 100 mg per day          up to week 52 if an initial response is achieved.        -  Arm B (control arm): prednisone alone at 1 mg/kg for 3 weeks followed by monitoring and          standard of care The aim of the study is to demonstrate the efficacy of dapsone based          on the overall response rate (including response and complete response) as a second-line          treatment for adults with newly-diagnosed persistent or chronic (modified by amendment          08/11/2016) ITP not achieving a durable response with corticosteroids. The primary          endpoint will be the overall response-rate (response or complete response according to          standard definitions) in both arms at week 52 (1 year).      The secondary endpoints are the following :        -  To assess the safety of dapsone over the study period and especially the incidence of          cutaneous reactions.        -  To analyze the overall response rate (platelet count > 30 x 109/L with at least a          doubling of the pre-treatment count in the absence of any other ITP treatment) in both          treatment arms at week 24.        -  To compare the rate of complete response and failure in both arms at 24 and 52 weeks.        -  To compare time to treatment failure (TTF) in both arms        -  To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients          (ancillary study)   "
50284|NCT02627404|"     Bipolar disorder is a complex, multifactorial disorder with the intervention of genetic     vulnerability factors. To help the identification of these genetic factors and to improve     genotype-phenotype correlation, the identification of endophenotype through the exploration     of vulnerability characteristics in unaffected first degree relatives have been recommended.     For this purpose, the investigator include bipolar patients, unaffected first degree     relatives and control subjects to perform genetic association studies and subphenotype     analyses. In this study the investigator will focus on subgroups defined according to the     existence of abnormal circadian rhythm (a major indicator of bipolar vulnerability).      Lithium is the leading treatment of bipolar disorders but prophylactic lithium response is     highly variable and difficult to predict due to lack of biomarkers of response. To explore     lithium response variability and to identify biomarkers of response, the investigator     characterise lithium response using ALDA scale to conduct pharmacogenetic studies and     pharmacokinetic studies of lithium extended release, in the subpopulation of patients treated     with lithium. As lithium is a circadian agent, the investigator will also explore the links     between lithium response and circadian phenotypes. Finally, using Li7 magnetic spectroscopy,     the investigator will compare lithium brain distribution in a small sample of good and     partial responders to lithium.   "
50285|NCT02627391|"     Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS)     saves lives. However there is currently no direct evidence for this and most recommendations     from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence.     Therefore, the investigators designed a randomized controlled trial to demonstrate whether     early surgery improves mortality and morbidity of patients with asymptomatic severe AS and     low operative risk.   "
50301|NCT02627183|"     The main purpose of this project is to determine the impact of atrial fibrillation     interventions (catheter ablation and exercise training) on circulating BDNF concentrations in     patients with atrial fibrillation. It also seeks to determine if there is a relation between     circulating BDNF concentrations and mental health (depression severity, quality of life and     symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or     exercise training.   "
50862|NCT02619851|"     This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test     the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn     wound subjects.   "
50286|NCT02627378|"     A highly pathogenic human coronavirus causing respiratory disease emerged in Saudi Arabia in     2012. This viral infection termed Middle East respiratory syndrome coronavirus (MERS-CoV) is     associated with high mortality rate in approximately 36% of reported patients.      The World Health Organization (WHO) reported 1,374 laboratory-confirmed worldwide infections,     including at least 490 related deaths, from September, 2012, to July 24, 2015.2 The higher     incidence of MERS-CoV infections in Saudi Arabia may be related to multiple factors,     including seasonality, increased proactive screening, poor infection control measures, low     relative humidity, and high temperature.      Infected patients with MERS-CoV usually have abnormal findings on chest radiography, ranging     from subtle to extensive unilateral and bilateral abnormalities. MERS progresses rapidly to     respiratory failure, in approximately 2/3 of infected patients, which has a high mortality     rate, particularly in immunocompromised patients.      Extracorporeal membrane oxygenation (ECMO) has emerged as a rescue therapy in patients with     refractory hypoxemia during the H1N1 epidemic.The use of veno-venous (VV)-ECMO provides     respiratory support for patients with respiratory failure, whereas the use of veno-arterial     (VA)-ECMO could be helpful in those with cardiorespiratory failure.10 However, the survival     rate of the infected patients with H1N1 who required the use of ECMO varies considerably     among the Caucasian and Asian countries (90% survival in Sweden and 83% in the UK13 vs. 35%     in Japan). This large discrepancy could be explained with lack of satisfactory equipment,     therapeutic guidelines, training of staff, and effective systems allowing patient transfer to     the dedicated ECMO centres.      Guery and co-investigators described the use of ECMO in two French patients with     cardiorespiratory failure secondary to MERS-CoV infection.This has been extended for     treatment of refractory hypoxemic respiratory failure during the Saudi MERS-CoV outbreak.   "
50287|NCT02627365|"     The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive     SMS intervention to optimize individual health and secondary HIV prevention benefits of ART     in HIV-positive FSWs.   "
50288|NCT02627352|"     The purpose of this study is to investigate the surgical outcomes of the micropulse     transscleral cyclophotocoagulation (mTSCPC) in patients with uncontrolled glaucoma; analyze     intraocular pressure lowering effect; and correlate related treatment parameters pending     enrollment of sufficient numbers of dark pigmented versus light pigmented eyes.   "
50289|NCT02627339|"     The purpose of this study is to build a database of results from a new test that measures     contrast sensitivity (the Spaeth-Richman Contrast Sensitivity Test (SPARCS)). Contrast     sensitivity is an important part of your ability to see. When contrast sensitivity decreases,     you are less able to see objects and detect motion. For instance, if you have decreased     contrast sensitivity, you might be less able to read, see in the dark, drive, hit a ball, or     walk safely. Decrease in contrast sensitivity leads to a decrease in quality of life.   "
50290|NCT02627326|"     The aim of this prospective randomized controlled clinical trial is to evaluate the     effectiveness of chlorhexidine intracanal medicament along with periodontal treatment in     concomitant endodontic periodontal lesions with communication in terms of periodontal     healing. Forty-seven patients were randomly divided into: group 1: conventional endodontic     treatment with open flap debridement (OFD after 3 month of endodontic treatment) were     performed, in group 2: endodontic treatment with 2% chlorhexidine gel (CHX) as an intracanal     medicament placed in root canals and after 3 month OFD were performed. Primary outcome     variables included probing pocket depth, clinical attachment level and bleeding on probing.   "
50291|NCT02627313|"     Conventional breast radiotherapy is delivered to the entirety of the breast in fractionated     treatments given over several weeks. While these techniques are effective, there is a risk of     late adverse events from irradiation of surrounding normal tissues and the protracted nature     of the treatments is inconvenient to patients and resource-intensive for health care systems.     There is an unmet need for novel treatments that can be delivered more quickly, with reduced     normal tissue exposure, and without compromising efficacy. The GammaPod is a breast-specific     radiotherapy delivery device that holds the promise in addressing these needs. Employing the     engineering and physics principles from stereotactic radiotherapy, it allows delivery of a     highly-localized radiation dose to a very limited volume of breast. The Ottawa Hospital is     the only Canadian member of a consortium of five academic institutions that have acquired the     GammaPod in order to rigorously evaluate its use in clinical trials. The aim of the current     project is to complete a mandatory clinical feasibility study of the GammaPod as part of the     application for Investigational Testing of Medical Devices from Health Canada. The study will     focus on the use of the GammaPod to deliver a radiotherapy boost, that is, a localized dose     of radiation just around the surgical bed, in a single treatment.   "
50292|NCT02627300|"     Patients will be followed from the time of completion of the SCGAM 01 trial until octanorm     becomes commercially available in the USA, until the sponsor decides to terminate the trial,     or until a patient's treatment duration of 2 years is reached (whichever occurs first).   "
50293|NCT02627287|"     This trial is conducted in Europe. The aim of this trial is to compare Injections with the     Medical Device DV3316 Pen-injector versus FlexPen®.   "
50294|NCT02627274|"     This open-label, multicenter, dose-escalation study will evaluate the safety,     pharmacokinetics and therapeutic activity of RO6874281 in participants with advanced and/or     metastatic solid tumors. Participants will be treated until disease progression or     unacceptable toxicity occurs, for up to a maximum of 24 months.   "
50295|NCT02627261|"     Three methods including flow cytometry, next generation sequencing and determination of     circulating tumor cells will be performed at different time points in patients with     previously undiagnosed multiple myeloma in order to determine the most sensitive method to     detect residual disease   "
50296|NCT02627248|"     RATIONALE:      Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely     used in China for many years. The investigators have found that Huaier could exert     synergistic effects with Epirubicin, Cyclophosphamide, and Paclitaxel on breast cancer cells.     It is not yet known whether combination chemotherapy is more effective when given together     with Huaier in the neoadjuvant setting .      PURPOSE:      To evaluate the effects of treatment with Huaier Granule in managing locally advanced breast     cancers with synergistic action of the neoadjuvant chemotherapy.   "
50297|NCT02627235|"     This pilot study represents an initial foray into delivering an Individual Voice     Response-based (IVR) physical activity intervention for cancer risk among sedentary adults in     the Deep South.   "
50298|NCT02627222|"     The study comprises an open-label randomized controlled trial investigating the efficacy of     consuming a daily ration of pro-vitamin A biofortified cassava on vitamin A status of     Nigerian children, aged 3-4 years old (n=200).   "
50299|NCT02627209|"     This study evaluates the significance of differences in serum angiotensin converting enzyme     and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and     infectious diseases.   "
50302|NCT02627170|"     The human cornea is affected by the magnitude and velocity of both internal and external     forces because the cornea has both static and dynamic resistance components. Considering     these natures of the human cornea, many investigators have tried to demonstrate corneal     biomechanical properties to understand these characteristics of the cornea. Corneal     biomechanical properties are known to influence the accuracy of measurements in intraocular     pressure (IOP) and are recognized as important factor to explain the susceptibility of     development of glaucomatous damage. Until recently, the only instrument which enabled the in     vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,     Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the     biomechanical properties of the cornea according to the dynamic bidirectional applanation     process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis     ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful     instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer     captures the dynamic process of corneal deformation caused by an air puff using an     ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,     well-organized analysis on the normative data of the corneal biomechanical profiles measured     with the dynamic Scheimpflug analyzer has not been reported yet. Hence, in the present study,     we aim to conduct normative data analysis for the corneal biomechanical properties with the     dynamic Scheimpflug analyzer in South Korea.   "
50303|NCT02627157|"     The human cornea is affected by the magnitude and velocity of both internal and external     forces because the cornea has both static and dynamic resistance components. Considering     these natures of the human cornea, many investigators have tried to demonstrate corneal     biomechanical properties to understand these characteristics of the cornea. Corneal     biomechanical properties are known to influence the accuracy of measurements in intraocular     pressure (IOP) and are recognized as important factor to explain the susceptibility of     development of glaucomatous damage. Until recently, the only instrument which enabled the in     vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,     Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the     biomechanical properties of the cornea according to the dynamic bidirectional applanation     process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis     ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful     instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer     captures the dynamic process of corneal deformation caused by an air puff using an     ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,     well-organized analysis on the normative data of the corneal biomechanical profiles measured     with the dynamic Scheimpflug analyzer for young healthy adults has not been reported yet.     Hence, in the present study, we aim to conduct normative data analysis for the corneal     biomechanical properties with the dynamic Scheimpflug analyzer in a cohort of young healthy     adults in South Korea.   "
50304|NCT02627144|"     This is a non-interventional, multicenter study to evaluate efficacy and safety of     intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for     first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC)     in daily routine.   "
50305|NCT02627131|"     The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow     mononuclear stem cells in the management of autism.   "
50306|NCT02627118|"     The aim of the study is to identify hepatic enzyme and estrogen-dependent biochemical changes     that occur when dialysis patients are treated with dialyzers known to leach BPA (Bisphenol-A)     into the blood, such as the commercially available Fresenius F160NR, as compared with the     same chemical evaluations in patients being treated with the non BPA containing ELISIO-15H     dialyzer. Evaluations of patient's chemistries will be obtained prior to and after 2 months     of standard dialysis treatments with each dialyzer.   "
50307|NCT02627105|"     This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight     loss program.   "
50308|NCT02627092|"     The purpose of this study is to assess the impact of copper linens on hospital acquired     infections and drug resistant bacteria.   "
50309|NCT02627079|"     The proposed pilot study will develop and test feasibility and preliminary efficacy of an     exercise motivation intervention using a 12-week smartphone-text messaging program tailored     to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors     and 15 patients actively undergoing cancer treatment.   "
50310|NCT02627066|"     This is a 12 month randomized clinical trial in which patients with renal failure undergoing     maintenance hemodialysis (MHD) therapy will be placed on a volume reduction protocol that     includes a novel low sodium dietary education program mediated by a lifestyle interventionist     with significant collaboration from the existing clinic staff. Participating patients will be     randomized to receive: 1) the volume control protocol alone (VC), or 2) the volume control     protocol + physical activity and exercise counseling (VCE) from the lifestyle interventionist     (LI). A research dietitian (RD), working in collaboration with the existing clinic RD, will     develop a program to immerse clinics in a culture of sodium restriction. The research RD will     train the LI and other clinic staff (nurses, technicians, etc) to help disseminate this     program, modeled after the clinic-wide dissemination approach used in Izmir, Turkey (Dr.     Ercan Ok). In addition, the LI will provide exercise and physical activity counseling to the     participants randomized to the exercise group, utilizing a SCT-based approach. The     Investigators hypothesize that mean arterial pressure will be reduced, and physical function     increased, in all patients at 12 months, but the magnitude of these improvements will be     greater in the VCE group.   "
50311|NCT02627053|"     Anticoagulant therapy is generally recommended for all patients presenting with acute     symptomatic splanchnic vein thrombosis, starting with either low-molecular weight heparin     (LMWH) or unfractionated heparin and continuing with the vitamin K antagonists in most     patients. Rivaroxaban is approved for the treatment of deep vein thrombosis and pulmonary     embolism, but no studies have assessed the safety of rivaroxaban in the setting of splanchnic     vein thrombosis. The investigators aim to collect prospective information on the safety of     rivaroxaban in a pilot cohort of 100 patients with acute splanchnic vein thrombosis without     liver cirrhosis.   "
51689|NCT02609035|"     ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to     improve adult vaccination rates for pneumococcal and herpes zoster vaccines.   "
50319|NCT02626949|"     By 2015 half of the people living with HIV infection in the U.S. are estimated be over the     age of 50, and this cohort of patients with well-controlled plasma viremia is aging at a more     rapid pace than their non-HIV peers. Long-term chronic inflammation plays a critical role in     premature aging in HIV-infected adults. Markers associated with chronic inflammation,     including IL-6, CRP, sCD14 and d-dimer, have not only been shown to be present at higher     levels in HIV-infected adults, but are also correlated to a wide variety of morbidities and     mortality. The goal of this project is to determine the impact of two different interventions     -- Mindfulness-Based Stress Reduction (MBSR) and Health Enhancement Program (HEP) -- on     reducing biological markers associated with chronic inflammation in HIV-infected adults with     an undetectable HIV viral load. In order to achieve this goal, a pilot RCT with 120 subjects     over 50 years old who are on anti-retroviral therapy (ART) will be conducted with the     following specific aims: 1) to assess the effect of MBSR and/or HEP on biomarkers of chronic     inflammation (IL-6, CRP, sCD14, d-dimer), and, 2) to explore whether changes in psychological     well-being (anxiety, depression, fatigue, cognitive functioning) mediate the impact on     chronic inflammation. Subjects will be randomized to participation in a group MBSR course or     to the HEP group both of which consist of 8 weekly sessions followed by 6 monthly booster     sessions. Three time points will be measured: baseline, 8 weeks (immediately after completion     of weekly intervention), and 6-months post-completion of weekly intervention. Mixed linear     and structural equation model will be used to test the study hypotheses. The proposed study     is innovative in that it is the first to explore the impact of a complementary mind-body     intervention on chronic inflammation in HIV-infected adults. Given that the consequences of     early aging in this cohort will be a burden on the health care system as well as a medical,     social and psychological burden on those living with HIV, the study has the potential to have     a major public health impact.   "
50320|NCT02626936|"     In previous studies, investigators have studied if a pre-meal insulin bolus based on     estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without     a significant degradation in postprandial glucose control. With this strategy, the patient     would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,     large or very large) It is however important to establish safety of this simplified meal     bolus approach. The safety of overestimating a meal insulin bolus in the context of single     and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer     simulation will be used to get a reasonable estimate of risks related to over-estimation with     single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be tested     in adults with type 1 diabètes      Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus     will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an     adequately estimated meal size bolus   "
50321|NCT02626923|"     Hypotension does not occur with Maraviroc at a dose of 600 mg/day   "
50322|NCT02626910|"     The project proposes to fill gaps in the understanding of disparities in healthcare and     primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries     with disabilities compared to those without disabilities. Studies document racial/ethnic,     economic, and education-related disparities, but little is known about healthcare disparities     related to disability.   "
50323|NCT02626897|"     This cross-over study of 12 patients with sarcoidosis will look at two different widely-used     accelerometer devices. These devices are wrist worn and similar in size to a wrist-watch.     They measure daily activity levels. The investigators hope to use one of these devices in the     future within a randomised-controlled trial looking at using methylphenidate for the     treatment of sarcoidosis-associated fatigue. In order to ensure that the investigators choose     the ideal device the investigators wish to compare the GENEActiv and ActiGraph GT3X devices.     Participants will be required to wear the devices for 7 days each, with 6 patients beginning     with the GENEActiv device and changing to the ActiGraph device after 7 days, the remaining 6     participants starting with the Actigraph before changing to the GENEActiv. Patients will     complete a short exit questionnaire about their experience with the devices and their     preference. The best device will be determined by both patient preference and reliability of     collecting data.   "
50324|NCT02626884|"     The purpose of this trial is to determine        1. Disease stabilization/response rate after six 21-day cycles of ibrutinib        2. Remission status after six, twelve and 20 21-day cycles of ibrutinib   "
50325|NCT02626871|"     The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and     major bleeding events in patients undergoing aortic valve replacement. This retrospective     multicenter registry will include 850 patients with aortic valve replacement using     bioprosthesis.   "
50326|NCT02626858|"     The aim of the present study is:        1. to verify whether the delineation of the tumour bed, based on the combination of the          visible postoperative changes and the position of the surgical clips on a CT scan in          treatment position acquired 1 week before the start of the radiotherapy (RT), provides          an accurate localisation of the boost volume compared to the localisation of the tumour          on a pre-operative CT-scan.        2. to document the changes that occur in the tumour bed as seen on a CT scan as a function          of the delay between surgery and radiotherapy.        3. to determine the ideal number and the positioning of the clips needed to reproduce the          best treatment volume for the boost.        4. to propose new guidelines for tumour bed definition and delineation based on the study          findings.   "
50327|NCT02626845|"     This is a phase IV, single-center, randomized, placebo-controlled pilot study that will     evaluate the efficacy of rituximab at inducing otolaryngologic remission in GPA patients with     active otolaryngologic disease.   "
50328|NCT02626832|"     This study aims to develop a method for the assessment of central NMDA receptor functioning     in patients with depression and schizophrenia. For this purpose a transitional approach is     used based on preclinical studies that show a dose-dependent relationship between the     activity of hypothalamic NMDA receptor and plasma AVP response to increasing plasma     osmolality. Patients with schizophrenia, depression and healthy controls participated in this     study. The Investigators found that in a subgroup of patients with schizophrenia the AVP     response was low and that in a subgroup of subjects with depression the AVP response was high     compared to healthy controls.   "
50350|NCT02626533|"     Persistent pain and joint stiffness after surgery may interfere with recovery and adversely     affect quality of life in up to 40% of patients who have undergone total knee arthroplasty.     There is growing evidence that inflammation as well as other medical and psychological     factors may be associated with osteoarthritis severity, progression, and associated pain     severity. This study aims to identify clinical, biological, and psychological factors that     contribute to and predict the development of these complications. Identification of such     factors may allow us to target preventative measures to the patients at highest risk of     persistent postoperative pain and joint stiffness.   "
76017|NCT02290834|"     This research study evaluates the effect of chemotherapy on cognition (thinking) and the     brain in people with breast cancer.   "
50329|NCT02626819|"     Compared to the general public, a higher percentage of Veterans are obese or overweight with     a weight-related medical condition. The VA currently offers an effective weight management     program called MOVE!, but the majority of eligible patients do not attend. Veterans see their     primary care providers (PCPs) very frequently, making it an important place to receive     information on weight management. However, PCPs often fail to discuss weight management with     patients, so interventions are needed to encourage weight management counseling within the     team-based care model used in primary care at the VA. Investigators used focus groups,     interviews, and other research methods to develop the MOVE! Toward Your Goals (MTG)     intervention. This intervention combines online tools, counseling by a health coach, and the     team-based care model to deliver weight management information to patients.      Investigators will conduct a randomized controlled trial of 320 Veteran patients and their     providers at two VA sites (Manhattan and Brooklyn campuses, New York Harbor Healthcare     System) to study the impact of the 12-month MTG intervention when compared to Enhanced Usual     Care. Veterans in the MTG intervention arm will take the MTG tool, receive personalized     weight management materials, health coach counseling, and go to their scheduled primary care     (PC) visit. After the initial visit, MTG-arm Veterans will receive follow up telephone     coaching over 12 months. All Veterans will attend follow-up visits at 3, 6 and 12 months to     assess body mass index, diet and physical activity, and goal attainment.      The objectives of this study are to: (a) test the impact of the MTG intervention on weight     and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting     techniques; and (c) determine the impact of the MTG intervention on primary care team     obesity-related counseling practices and attitudes.   "
50330|NCT02626806|"     1. To compare hs-TnT levels after a cardiac stress test in patients with vs. patients          without CAD        2. To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)        3. To determine the sensitivity, specificity and accuracy of this exercise-induced hsTopT          level in predicting CAD, either alone or in relation to traditional patient-related and          exercise test-related metrics   "
50331|NCT02626793|"     The objective of this Non-interventional study (NIS) is the collection of data on the     utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and     treatment satisfaction on treatment with Apremilast in daily practice will be documented.     Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast     will be recorded.   "
50332|NCT02626780|"     The general objective of this study is to conduct a safety and feasibility study of a single     injection of autologous adipose-derived SVF for the treatment of alopecia.   "
50333|NCT02626767|"     Low-volume high-intensity interval exercise training may improve aspects of health and     fitness in young people, but interventions must be practical and engaging. The investigators     examined the effect of a novel school-based low-volume high-intensity interval training     programme on health, fitness and physical activity outcomes in adolescent school pupils. 101     English adolescents aged 13-14 years took part in the study. Participants were healthy male     and female volunteers, recruited from four schools in Northeast England. Using a     non-randomised design, two schools took part in the intervention, and two were assigned to     the control. Those in the intervention group completed a 10-week school-based high-intensity     interval exercise training programme. The intervention took place three times per week, and     comprised of 4-7 repetitions of 45 s maximal effort exercise (boxing, dance, soccer and     basketball drills), each interspersed with 90-s rest. Participants were encouraged to work     maximally during the 45-s repetitions. Control participants were instructed not to change     their lifestyle, dietary or physical activity habits during the intervention period, and     maintain their normal school physical education routine. Study outcomes were blood lipid and     glucose levels, body composition, cardiorespiratory fitness, carotid intima-media thickness,     physical activity levels, serum C-reactive protein levels and blood pressure.   "
50334|NCT02626754|"     This is a multi-national, phase II, single arm study to explore the safety/efficacy and     potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell     carcinoma.   "
50335|NCT02626741|"     The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective     in the treatment of obesity patients with metabolic syndrome.   "
50336|NCT02626728|"     Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with     single-port technology has allowed that pelvic surgery can be laparoendocopically performed     from both its abdominal and perineal aspects.Previously, a strong negative association     between medium- and long-term survival and male gender with narrow pelvis have been reported.     TAMIS has a significant potantial for improving the quality of the surgical resection of     rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have     also a high rate of conversion to open surgery. Focusing on improvement in intraoperative     conditions and surgical techniques rather than routine conventional procedures may be the way     to go concerning favorable short- and long-term outcomes. The selection of adequate surgical     approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or     limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a     prospective observational feasability study of the TAMIS-procedure.   "
50337|NCT02626715|"     The purpose of this study is to compare safety and efficacy of reduced-intensity conditioning     and myeloablative conditioning regimens prior to HSCT in high-risk AML/MDS pediatric and     young adult patients. This study investigates the use of two novel conditioning therapies for     hematopoietic stem cell transplant (HSCT). The primary focus of both the investigators'     myeloablative and reduced-intensity conditioning regimens is to reduce overall toxicity so     that pediatric and young adult patients with high-risk AML/MDS with significant pretransplant     comorbidities who would have been ineligible to proceed to HSCT previously can now receive     potentially life-saving treatment.   "
50338|NCT02626702|"     Exploring the immune mediators of early pregnancy prospectively may help to identify new     early interventions that will increase the likelihood of success and help women make informed     decisions regarding their pregnancies.   "
50339|NCT02626689|"     This is a multi-site, prospective, observational study implemented in β-thalassemia treatment     centers from 5 countries (Italy, Turkey, Greece, Lebanon, and Thailand). Approximately one to     two study sites will be identified per country and approximately 20 β-thalassemia subjects     will be enrolled per country (10 transfusion dependent (TD) and 10 Non-transfusion dependent     (NTD) with a total of approximately 100 subjects. This study will not interfere with or     influence the routine clinical management of β-thalassemia patients. Outcomes of interest     will be collected prospectively for up to 6 months.   "
50351|NCT02626520|"     Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease     will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then     surgical resection for those with resectable or borderline resectable disease. The primary     endpoint is disease-free survival at 1 yr from initiation of treatment.   "
50340|NCT02626676|"     Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as     possible in order to minimize the complication-related risks. Encouraging patients to adhere     to their treatment plans is a great challenge for health care professionals. Objectives: The     aim of this study is to evaluate the impact of a nutrition educational programme on the     hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods:     A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D     Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The     educational intervention consists of lectures and group dynamics sessions performed during     dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum     phosphorus concentration will be evaluated and the transtheoretical model of eating behavior     (TMFB) will be applied pre- and post-intervention.   "
50341|NCT02626663|"     The investigators propose to characterize MPs in aHUS and TTP both at the onset and     throughout treatment. The investigators believe that the number, size, and cell origin of MPs     will differ between these two diseases. The hypothesis is that endothelial derived MPs will     be higher in number and comprise a larger portion of the MP population in aHUS and that     platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The     investigators believe that MP identity and number can be used to reliably differentiate     between aHUS and TTP at disease onset.   "
50342|NCT02626650|"     College athletes will be recruited to complete a voluntary online survey that will take     approximately 10 minutes. In this survey, they will answer a series of questions related to     the concussion symptoms they have experienced in their recent sports season, their opinions     related to concussions and concussion treatment, and demographics.   "
50343|NCT02626637|"     During cancer treatment children are less active than their health peers. This inactivity     persists into survivorship and can negatively affect health and quality of life. Physical     activity may also improve fatigue, a prevalent and distressing symptom during treatment.     Improving health behaviors during treatment can have lifelong benefits for cancer survivors.     In this study, the effectiveness of the Kids are Moving exercise program will be evaluated.     The exercise program will follow program guidelines set up by the American College of Sports     Medicine and will be adapted for children with cancer. Children ages 6 to 18 years, who are     receiving chemotherapy, and their parents, will be coached on how to increase their physical     activity and will receive an exercise prescription. This will occur as part of the standard     care they receive from the nurse practitioners during the first six months of their     outpatient visits. Investigators want to find out if children in the Kids are Moving program     are more active and have less fatigue. Activity will be measured through patient     questionnaires about activity and fatigue, and by wearing the FitBit activity tracker and an     actigraph. Outcomes will be compared to measurements collected from children who received     usual care before the exercise program started.      Physical activity is a vital for improving health and quality of life and for providing     energy for engaging in positive life experiences as children move along the developmental     continuum to a long and healthy future. Outcomes of the study will provide a foundation for     larger multi-site clinical trials.   "
50344|NCT02626611|"     This is a phase 2 randomized, double-blind, placebo controlled study which will be conducted     at multiple centers in the U.S. All subjects will receive oral immunotherapy for their     specific food allergies (limited to 5 of those food allergens in Investigational New Drug     (IND) 14831). All subjects will receive Omalizumab for 16 weeks. The subject's allergens will     be introduced in a rush desensitization day at week 8. Subjects will return to clinic to     escalate the dose of their allergens until 2,000mg protein of each allergen is reached     Subjects will return to clinic for a DBPCFC to each allergen at week 30. If subjects are     nonreactive to 2 or more allergens during their DBPCFC at week 30 they will be randomized to     one of three double blinded arms: Arm A- continue with current dose (2000 mg each food     allergen protein), Arm B-300 mg of each food allergen protein, Arm C-placebo (avoiding food     allergen protein), their current dose. All subjects will return to clinic for a DBPCFC to     each allergen at week 36. The final challenge of week 36 will be the final end of study     visit.      Safety is a paramount concern in the study design and will be monitored carefully throughout     the study. Study subjects and their parents/guardians will receive extensive education on     food allergy reactions and medication use.   "
50345|NCT02626598|"     This is a single center study for adult females or males ages 25 to 75 years who are seeking     treatment for etched-in fine lines of the cutaneous lip, and/or radial cheek area, and/or     nasolabial folds, and/or melolabial folds, and/or forehead. The purpose of this study is to     evaluate blended Belotero for the treatment of etched-in fine facial lines and to monitor for     adverse events.   "
50346|NCT02626585|"     The purpose of this study was to investigate the effectiveness of postrhinoplasty taping. The     effectiveness was evaluated with Ultrasonography and skin envelope thickness was     prospectively measured for analysis.   "
50347|NCT02626572|"     The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in     patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An     optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy     of S47445 in co-administration with donepezil.   "
50348|NCT02626559|"     Serum levels of bupivacaine over time after peri-articular injection of a mixture of     liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.   "
50349|NCT02626546|"     This is a multicentre, prospective, observational cohort study. Consecutive patients,     operated in six University Hospitals in Sweden will be recruited following major surgical     procedure. The length of patient recruitment period will be 12 weeks. The length of follow up     will be 360 days . The objectives are to determine the postoperative morbidity (during the     hospital stay), the survival (0-360 days), to identify risk factors for adverse outcomes and     to identify risk factors that may potentially be influenced by any intervention in the     future.   "
50408|NCT02625779|"     This research is aimed to investigate the efficacy and safety of the creatine and cytidine     augmentation in treating bipolar depression and to evaluate changes in relevant brain     biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.   "
50409|NCT02625766|"     Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures     encountered. There is a substantial amount of controversy surrounding the treatment of these     injuries and there is evidence that both operative and non-operative treatment can be     successful.   "
50356|NCT02626455|"     The purpose of this study is to assess whether copanlisib in combination with standard     immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in     combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and     prednisone/prednisolone [R-CHOP]) is effective and safe compared with placebo in combination     with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have     received at least one, but at most three, lines of treatment, including rituximab and     alkylating agents.   "
50357|NCT02626442|"     The risk of stroke and vascular dementia is high in individuals who have had a prior stroke     or TIA, and in those who have vascular disease risk factors, such as high blood pressure,     abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can improve with     exercise. This study will examine the impact of a 6 month, low intensity group exercise class     on fitness, walking, balance, and brain health.      This study will also collect fitness, walking, balance, and brain health outcome measures at     baseline and post all other MERCE exercise and robotics interventions.   "
50358|NCT02626429|"     Protein requirements in active individuals have been suggested to be greater than the current     recommended dietary allowance (RDA).      Nutritional requirements for dietary amino acids in adults have traditionally been determined     utilizing the nitrogen balance technique, which is prone to underestimating protein     requirements. As a result, there is a need to re-evaluate recommendations in order to     characterize how dietary amino acid needs may be modulated by physical activity.      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique     have suggested that protein requirements in young men are at least 50% higher than the RDA     based on nitrogen balance data.      The purpose of this study is to measure the protein requirement in active, young adult     females using the IAAO technique in the presence of a variable intensity exercise stimulus.   "
50359|NCT02626416|"     The incidence rate of postoperative capsular opacification (PCO) in children after cataract     surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy     is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term     follow-up, timely diagnosis and treatment is important to improve patient's outcome.      The major and central part of lens is easy to be observed through a dilated pupil.     Especially, opacification in the lens and/or lens capsule is distinctive showing as white     on the black background. The characteristic features of the disease and advances in     photographic technique with mobile phone make it possible for patients and/or their guardians     to monitor the progress of cataract or PCO with mobile application in a self-help manner     under non-clinical settings.   "
50360|NCT02626403|"     Previous studies showed that anodal transcranial direct current stimulation (tDCS)     transiently improves performance of memory and attention. In severely brain injured patients     with disorders of consciousness (DOC), a single stimulation over the left dorsolateral     prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other     brain areas could be stimulated in order to increase the number of responders. In this study,     investigators will assess the effects of bilateral fronto-parietal tDCS on Coma Recovery     Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled     experimental design.   "
50361|NCT02626390|"     This study examined the feasibility of using implicit and explicit learning approaches during     gait rehabilitation in the early phase following stroke. It was a double blind trial     (participants and assessors) using a matched pairs design. Participants were recruited from     an acute stroke unit, and were randomised to receive gait rehabilitation over three     consecutive days using either an implicit or explicit approach. Guidelines for each were     developed empirically, including differences in the amount, timing, and attentional focus of     therapists' verbal communication. Sessions were recorded and their content analysed to     establish concordance with the guidance. Clinical measures were taken at baseline and 24     hours post intervention using the Berg Balance Scale and the Step Test. Therapists were able     to adhere to the guidance. Both approaches were found to be acceptable to both patients and     therapists. The findings will be used to design an appropriately powered RCT.   "
50410|NCT02625753|"     Compare the use of codeine/paracetamol against placebo for pain control after cornea     photorefractive keratectomy (PRK).   "
50411|NCT02625740|"     The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate     the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to     improve local Paclitaxel delivery effects in critical limb ischemia patients due to     femoral-popliteal artery disease.   "
50412|NCT02625727|"     Using double blind, randomized controlled design to study the immediate, short-term and     intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and     hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.   "
78570|NCT02257450|"     This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult     population.   "
50362|NCT02626377|"     Medical progress and modification of lifestyles have prolonged life expectancy, despite the     development of chronic diseases. The support and care are often provided by a network of     informal caregivers composed of family, friends, and neighbors. They became essential to help     maintening the elderly persons to live at home. It has been demonstrated that the importance     and the diversity of informal tasks may jeopardize their own physical, mental and social     well-being.      The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study     of their life course, the profiles of caregivers of patients with a diagnosis of one of the     following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases     (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases     (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease     (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following     the different phases of the caregiving relationship from the announcement of the diagnosis,     it will be possible to assess the quality of life of caregivers and evaluate the     implementation of a pragmatic social action to help informal caregivers through a randomized     intervention trial nested in the cohort.      Thanks to an analytical and longitudinal definition of the profiles of informal caregivers,     this study could gather precise information on their life courses and their health trajectory     by identifying the consequences associated with the concept of their role of aid in care. In     addition, the randomized intervention trial will explore the efficacy, in terms of quality of     life, and efficiency of a social action to support the caregivers. These data will allow to     identify strategies that could be used to improve the existing sources of aid and to propose     new approaches to help caregivers. This study will provide the opportunity to identify the     most relevant means of support and to give an impulse for new healthcare policies.   "
50363|NCT02626364|"     This is a proof of concept, single-arm study to investigate crenolanib monotherapy in     patients with recurrent/refractory glioblastoma with PDGFRA gene amplification by assessing     the progression-free survival (PFS) at 6 months. Crenolanib will be given orally starting at     100 mg TID continuously until disease progression, unacceptable toxicity, or consent     withdrawal.   "
50366|NCT02626325|"     High saturated fat acids diets are associated with elevated blood pressure which is     associated with cardiovascular morbidity and mortality. For this reason, a change of diet is     recommended to manage blood pressure and prevent cardiovascular complications. To achieve     this nutritional goal, a high-carbohydrate diet or high-monounsaturated fat diet can be     advised in the replacement of a saturated fat diet.      Previous meta-analysis of Garg (1998) cited randomized articles with inconsistent blood     pressure lowering after consumption of a high-monounsaturated-fat diet compared with a     high-carbohydrate diet only in type 2 diabetes patients. Moreover, another meta-analysis of     Shah et al. (2007) showed slightly high blood pressure on diets rich in carbohydrates than     diets rich in cis-monounsaturated fat after randomized and nonrandomized articles.      For this reason, a new meta-analysis of a randomized clinical trial will be performed to     clarify the effects of high-carbohydrate or high-monounsaturated fat diets on blood pressure.     Results from this meta-analysis will help health professionals take important decisions on     patient diet and minimize cardiovascular morbidity and mortality.   "
50367|NCT02626312|"     The goal of this clinical research study is to find out if the new method of giving radiation     to the liver can be given safely to patients who already have liver problems.   "
50368|NCT02626299|"     The purpose of this study is to determine if giving a larger amount of DHA than currently     included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks     of pregnancy).   "
50369|NCT02626286|"     The objective of the study is to evaluate the feasibility and interest of a HIV quarterly     preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help     reducing HIV incidence in this key population, their female partners, and the general     population. This interventional, open label, multicenter, multidisciplinary cohort study will     be conducted in Burkina Faso, Ivory Coast, Mali and Togo.      All participants will receive a HIV quarterly preventive global care including:      i) data collection on health status, symptoms of sexually transmitted infections (STI) and     sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv)     counselling adapted for MSM, and v) the provision of condoms and lubricants.   "
50370|NCT02626273|"     The present protocol is mainly involved in the understanding of the local interaction between     the released products by fat tissue and hormones production of bone tissue. These complex     interactions between adipocyte and osteocyte activities could explain the mechanisms of the     body responses to the strategies of weight loss that include diet and/or physical activity     program, as well as the side effects encountered by these interventions.      Adolescence is a period of development characterized by many metabolic and somatic changes     that may influence weight. Weights bearing physical activities are a key factor allowing body     composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the     onset of overweight and obesity during this very important growth spurt lead to various     hormonal dysregulation. The specific mechanisms of the evolution and interactions between     these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to     analyze the possible connections between fat tissue and the quality of the skeleton in order     to reduce related risks of the consequence of weight loss in obese individuals.   "
50371|NCT02626260|"     The study investigates the impact real output has on the adhesion of adhesives.   "
50372|NCT02626247|"     Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long     chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in     healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms)     placebo-controlled design.   "
50373|NCT02626234|"     the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and     rosuvastatin in patients with cMET-dysregulated advanced solid tumors   "
50413|NCT02625714|"     A randomized, open-label, oral multiple dosing, two-part, two-way crossover clinical trial to     evaluate the safety/tolerability and pharmacokinetic profiles of SID142 in healthy volunteers   "
50433|NCT02625454|"     The investigators plan to administer acetaminophen (Tylenol) for the treatment of fever in     laboring patients by either an oral or intravenous (IV) route. The investigators want to see     if the maternal fever will decrease faster with the IV or the oral dose. The investigators     also want to look at other outcomes such as the cesarean section rate, the rate of neonatal     intensive care unit admissions in both groups.   "
50374|NCT02626221|"     This is a non-interventional, multi-country, Latin American study utilizing a prospective     single-cohort design. Eligible CU patients will be enrolled in the study and will be followed     for 24 months (± 6 weeks).      In accordance with the observational nature of the study, there will be no interventions or     interference with the routine care of the patient which will be based solely on the clinical     judgment of the treating physician. However, with respect to the frequency and schedule of     assessments, the schedule included in Table 7-1 will be recommended.      The selection of the treatment for CU will be clearly separated from the decision to include     the patient in the study, and will be made at the discretion of the treating physician in     accordance with standard medical practice, the investigator's clinical judgment, and global     urticarial guidelines.      In order to prevent selection bias, investigators should offer enrollment to all consecutive     patients meeting study criteria, likely to be available for the full duration of the     follow-up period of 24 months, and willing to participate in the study.      The overall objective of the study is to evaluate in real-life the CU disease burden, the     current treatment patterns and the use of health care resources in patients refractory to     H1-antihistamine treatment   "
50375|NCT02626208|"     This clinical trial investigates a new vaginal delivery system made of silicone rubber,     containing Nestorone®, a 19—nor progesterone derivative and a low dose of serum estradiol     (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of     three different contraceptive vaginal rings that contain a fixed dose of NES and escalating     doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR     for a larger contraceptive efficacy trial.   "
50402|NCT02625857|"     The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of     JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in     which two virulence genes, which encode molecules that help cause disease, have been removed)     when administered intravenously to participants with metastatic castration-resistant prostate     cancer (mCRPC).   "
50376|NCT02626195|"     Malnutrition patients are known to have more postoperative complications and mortality. And     most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and     mortality rate. Therefore for the malnourished patients anticipating major surgery,     preoperative nutritional support is recommended according to the ASPEN (American society of     parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral     nutrition) guideline. However there is no prospective trial to prove the clinical impact of     preoperative nutritional support for malnourished patients.      The purpose of this study is to evaluate the clinical impact of preoperative nutritional     support for malnourished cancer patients anticipating HBP surgery. Primary objective is to     compare the complication rate and secondary object is to compare the quality of life,     hospital stay and cost.   "
50378|NCT02626169|"     Ticagrelor and clopidogrel are FDA-approved drugs for inhibition of platelet hyper-reactivity     in certain clinical situations. The platelet inhibition and patient outcomes (PLATO) trial     showed that in patients with acute coronary syndromes, ticagrelor significantly reduced the     primary endpoint (cardiovascular death, myocardial infarction or stroke), all-cause mortality     and cardiovascular mortality compared to clopidogrel. It has been suggested that in addition     to its anti-platelet effects, ticagrelor has additional unique effects, including     anti-inflammatory effects that are not shared by clopidogrel. In the present study the     investigators will assess whether ticagrelor, as compared to clopidogrel, increases serum     levels of 15-epi-lipoxin A4, a potent endogenous anti-inflammatory mediator.   "
50379|NCT02626156|"     The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management     ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic     foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month     randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of     cooling gel pack or placebo will be applied three times weekly to the affected skin, and a     bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes     elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and     quality of life will be measured.   "
50380|NCT02626143|"     This study is intended to compare growth, nutritional status, and brain development in     children fed an Investigational cow's milk based formula containing a nutrient-rich whey     protein, a standard cow's milk based formula, or fed exclusively breast milk.   "
50381|NCT02626130|"     The goal of this clinical research study is to compare the safety and effectiveness of     tremelimumab alone and in combination with cryoablation in patients with metastatic kidney     cancer (clear cell or non clear cell type) having surgery. Researchers also want to learn how     the combination may affect the immune system.      Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and     destroy cancer tissue.   "
50382|NCT02626117|"     The concept of laser deepithelialization to retard epithelial migration has enabled new     attachment formation in periodontal pockets. Based on this hypothesis, that laser     deepithelialization during root coverage procedures will enhance clinical outcome, a split     mouth randomized controlled clinical trial was planned to compare the clinical outcome of     Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in     combination with laser de-epithelialization in the treatment of gingival recession.   "
50383|NCT02626104|"     This prospective, randomized, parallel-group, double blind, single-center study is to be     conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in     following departments: Department of Paediatric Gastroenterology and Nutrition, Department of     Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of     Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a     total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy     because of acute respiratory tract infection/or urinary tract infection. The children will be     randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for     the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of     diarrhea during the antibiotic therapy and two weeks after, defined as > 3 stools a day, a     watery or loose stool with/or occurrence of blood in the stool.   "
50384|NCT02626091|"     The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented     with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to     validate the accuracy of this technique with metabolic intestinal cells changes.   "
50385|NCT02626078|"     Nutrition is an essential component of health and a key determinant of aging and quality of     life of individuals. Malnutrition in the elderly is now recognized as a public health problem     affecting nearly half of residents in nursing homes. The fight against malnutrition requires     to rethink the meal in all its dimensions, beyond the nutritional needs. In order to improve     practices of care at the elderly, the impact of environmental and social aspects of food in     nursing homes has been assessed. The social environment and interactions during the meals are     now identified as effective ways to stimulate food intake and increase feelings of well-being     in the elderly.      The objectives of the study are to characterize the appreciation of food and social     interactions during the meals and to study the relationships between the quality of food     practices and nutritional status of the residents in nursing homes to improve their quality     of life.   "
50386|NCT02626065|"     This is an open mono-centric prospective non-randomized study in patients with metastatic     melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to     identify the immune cells modulations differences between patients who present a complete,     partial or stable response and patients who have non-response to the therapy in order to     establish an improving response rate strategy.   "
50387|NCT02626052|"     The purpose of this study is to explore the diagnostic values associated with both a positive     and negative Skull Vibration Induced Nystagmus Test (SVINT) performed in room light (with     fixation). The hypotheses include: 1. A positive room light SVINT will be identified in     individuals with moderate to severe vestibular asymmetries. 2. A positive room light SVINT     will be present when 10 beats or more (counted over 10 seconds) of nystagmus are found with     fixation blocked.   "
50509|NCT02624453|"     The aim of the study is to evaluate systematic pre-antiretroviral cryptococcal antigen     screening and pre-emptive fluconazole therapy in antigen positive patients, as a strategy to     reduce morbidity and mortality due to AIDS associated cryptococcal meningitis in patients     starting antiretroviral therapy at <100 CD4 in Cameroon.   "
50388|NCT02626039|"     Characterization of the driver mutations in an individual metastatic breast cancer patient is     critical for many reasons. Effective targeted therapies require identifying genomic     alterations in the tumoral tissue. The scarce efficacy of many currently available targeted     drugs may be due to the outbreak of resistant clones with different genotype that already     present at the initiation of therapy. It is well known the intra-tumor heterogeneity with     genetic and non-genetic factors considered as the origin of the tumor cell-clon composition.     The acquisition of multiple mutations (driver and passenger), altogether with the stage of     differentiation, according to the cancer stem cell hypothesis, confers to the tumor cells     clinically important properties, such as resistance to therapies and seeding abilities.      Moreover, there is a current challenge in establishing whether the metastatic cells arise     from the most aggressive and dominant clone in the primary tumor or the metastasic tissue     diverges with substantial genetic changes very early in the evolution of the disease. Primary     and metastatic tumor may have a close clonal relationship or evolve in parallel and acquire     different genomic alterations. In the real life, it is plausible that both models coexist     with different predominance according to the tumoral tissue and etiology.      The study hypothesizes that breast cancer metastases and primary tumors could harbor     different genomic profiles related to genomic regions of interest in a clinically relevant     proportion of metastatic breast cancer patients.      Moreover, the genomic aberrations found in the metastatic breast cancer tissue could also be     detected in CTCs and circulating free DNA.      If true, CTCs and circulating free DNA would be convenient, non-invasive, easily accessible     sources of genomic material for the analysis of mutations and other genomic aberrations.   "
50389|NCT02626026|"     This study will consist of two parts: Part A will evaluate the safety, tolerability,     pharmacokinetics (PK), and pharmacodynamics (PD) of GS-4059 in healthy participants. Part B     will evaluate the safety, tolerability, and the effect of GS-4059 on disease-specific     clinical markers and outcomes in participants with rheumatoid arthritis (RA).   "
50390|NCT02626013|"     This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical     outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat     population. Notably, the data generated in the context of this study will serve as     complementary evidence to that of the tightly and strictly controlled pre-registration     clinical trial setting, which is of essential importance especially in patient populations     with diseases of complex and heterogeneous biology, such as breast cancer.   "
50391|NCT02626000|"     A Phase 1b/3 Multicenter, Randomized, Trial of Talimogene Laherparepvec in Combination With     Pembrolizumab for the Treatment of Subjects with Recurrent or Metastatic Squamous Cell     Carcinoma of the Head and Neck   "
50392|NCT02625987|"     To compare the results associated with two different skin closure techniques in open     appendectomy. 200 patients were included after acute appendicitis diagnosis in emergency     department. They were grouped randomly into two groups: patients who would receive skin     closure with skin closure by an unique absorbable intradermic stitch (Group A) and another     that would receive a habitual technique consistent in non absorbable separated stitches     (Group B). General characteristics like gender, age, body mass index (IMC), comorbidities and     allergies were registered. Days of evolution (DOE) until surgery, use of antibiotics     previously, complicated or uncomplicated appendicitis, surgery time and wound complications     like skin infection, dehiscence, seroma or abscess were registered in each case too,   "
50393|NCT02625974|"     This study was designed to develop a better understanding of the efficacy,     safety/tolerability, and pharmacokinetics (PK) (absorption, distribution, metabolism, and     elimination) of nifurtimox in children with a diagnosis of Chagas' disease (Trypanosoma cruzi     infection) using pediatric formulations.   "
50394|NCT02625961|"     In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC)     unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for     or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The     primary study hypothesis is that treatment with pembrolizumab will result in a clinically     meaningful response.   "
50395|NCT02625948|"     The purpose of this study is to determine if computed tomography angiography can predict     which individuals with intracerebral hemorrhage will experience significant growth in the     size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study     will compare the drug Tranexamic acid to placebo to determine the effect and safety of on     intracerebral hemorrhage growth   "
50396|NCT02625935|"     This multicenter, prospectively designed study examines whether the Prosigna score influences     physician and patient adjuvant treatment selection over and above currently used prognostic     factors. This study also examines the impact of the test results on patients' reported     outcomes, including their decisional conflict status and anxiety levels.   "
50397|NCT02625922|"     This is a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II     clinical study to evaluate the effect of serelaxin versus placebo (both in addition to SoC)     on the release of hs-cTnI, in patients with CHF after an exercise testing session.   "
50431|NCT02625480|"     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell     therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric     or adolescent subjects.   "
50398|NCT02625909|"     The aim of the study is to determine if treatment for recently acquired hepatitis C infection     (with or without HIV coinfection) can be shortened when treating with the interferon-free     therapy sofosbuvir/velpatasvir (SOF/VEL).      SOF/VEL is a new treatment for hepatitis C called direct acting antiviral which targets the     hepatitis C virus replication cycle and has been shown in phase II studies in chronic HCV to     be highly effective (SVR12 >95%) when given for 12 weeks.      Data has shown that treatment can be shortened when treating recently acquired HCV with     interferon containing treatments. It is not known whether treatment with SOF/VEL can be     shortened.      This study aims to find out if treatment for 6 weeks with open-label SOF/VEL is equivalent to     treatment for 12 weeks with SOF/VEL in participants with recently acquired hepatitis C     infection. The project is a randomised study where both participants and investigators would     not find out the treatment duration of the participants until week 6 of treatment.   "
50399|NCT02625896|"     This study aims to evaluate the use of an aerial human body manoeuvre to reduce the     biomechanical load on the neck of a parachutist during the parachute opening, in order to     create a basis for future prevention of skydiver neck pain in the parachutist population.   "
50400|NCT02625883|"     The investigators will retrospectively examine all patients with out-of-hospital     resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the     year 2013 with a one year follow-up and a structured interview about Quality of life.     Furthermore, the costs generated by the local health system are analysed.   "
50403|NCT02625844|"     This study is to document the time spent by health care personnel on anemia-related tasks,     including preparation, distribution and administration of monopegylated epoetin beta     (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal     disease in hemodialysis centers in Croatia. The total average time will be determined for the     same number of patients on monopegylated epoetin beta and patients on other ESAs. In     addition, qualitative information will be obtained on changes in practice patterns that may     have occurred with the introduction of monopegylated epoetin beta.   "
50404|NCT02625831|"     Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the     production of multiple autoantibodies. Antibodies against Ficolin-3 were previously     identified in the sera of some SLE patients, but their prevalence and significance have not     been yet investigated. The aims of this study were to determine the prevalence of     anti-ficolin-3 antibodies among SLE patients and to investigate their potential as diagnostic     and/or prognostic biomarkers in SLE.      In this retrospective study, clinical data were obtained from medical files and blood samples     were selected from preexisting biological collection. SLE patients (n=165) were informed and     did not objected, they were matched to healthy controls (n=48). Disease activity was     determined according to the SLEDAI score. Anti-ficolin-3, anti-dsDNA and anti-C1q antibodies     levels were measured in sera by ELISA. First, a highly significant difference was found in     the anti-ficolin-3 levels between SLE patients and healthy subjects. Anti-ficolin-3     antibodies were detected as positive in 58 of 165 (35%) SLE patients. The titer of     anti-ficolin-3 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of     anti-ficolin-3 antibodies was associated with anti-C1q and anti-dsDNA antibodies. Regarding     associations with clinical manifestations, only the presence of active lupus nephritis was     significantly associated with the presence of anti-ficolin-3 antibodies (p=0.0001). This     association with renal involvement was higher with anti-ficolin-3 antibodies than with other     auto-antibodies. Interestingly, the combination of anti-ficolin-3 and anti-C1q antibodies     demonstrated higher specificity than any other traditional biomarker.      These results suggest that anti-ficolin-3 could be useful for the diagnosis of active     nephritis in SLE patients.   "
50405|NCT02625818|"     A major proportion of patients admitted to psychiatric acute and emergency departments have     symptoms, behaviors or function influenced by implicit or explicit suicidal intention     (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in     the acute phase during in-patient stay and after discharge. At present there is no     satisfactory tool to predict post-discharge suicide risk.      Multidimensional rating is expected to have better predictive properties than one-dimensional     rating for suicidal behavior during in -patient stay and two years after discharge.     Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and ideations,     as well as therapist's reactions during interviews. In the present study the predictive     properties of two rating scales for suicidal behavior during in-patient stay and two years     after will be compared. One of these is a multidimensional scale: Multidimensional     Assessment of Suicide Risk (MARIS).   "
50406|NCT02625805|"     This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD     subjects with an easy to use EEG Device.   "
50407|NCT02625792|"     SD has become a standard treatment of gastric neoplasm confined to mucosa(epithelium). But     after procedure, formation of iatrogenic gastric ulcer is inevitable. And Post ESD ulcer     bleeding rate reported about 5% ~ 10% of all cases. Antiplatelet or anti-coagulation     treatment might be associated higher incidence of rebleeding after ESD and iatrogenic ulcer     bigger than 40mm in size is also associated.      Though several previous study have failed to show efficacy of 2nd look EGD, but those reports     pointed out that visible vessels with current bleeding or highly suspect of recent bleeding     (Forrest type IA~IIB) was observed about 10~20% of patients. Such patients are at high risk     of bleeding.      So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a     significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus     visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And     finally this protective effect might have an effect for prophylaxis of post ESD ulcer     bleeding.   "
50414|NCT02625701|"     There is no ideal cookbook recipe for fluid prescription that would fit every surgical     patient.      In this study, the investigators working hypothesis is that the adoption of an integrative     algorithm for perioperative fluid and haemodynamic management would improve clinical outcome     and reduce hospital resource utilization in noncardiac surgical procedures     (major-to-intermediate level of stress.      Two intraoperative fluid strategies will be compared: Restrictive vs. goal-directed     therapy (GDT). In the GDT group, haemodynamic information will be obtained by a flow     monitoring device coupled with standard heart rate and blood pressure monitoring.   "
50415|NCT02625688|"     Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of     years. Based on published data, numerous neonatal benefits have been suggested such as     increased hemoglobin and ferritin levels both at birth and longer term. Available systematic     reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other     neonatal outcomes including polycythemia and hyperbilirubinemia.      A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4     studies which as a second objective assessed whether the time of cord clamping was associated     with an increased risk of polycythemia and hyperbilirubinemia during the first week of life.     Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No information is     provided on what hour of life the bilirubin levels were measured exactly.      In this randomized control study the investigators would like to determine if delayed cord     clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring     phototherapy) in term infants.   "
50416|NCT02625675|"     The observational pilot study at the Churchill Hospital, funded by Oxford Respiratory Trials     Unit, will assess the feasibility and efficacy of thoracic ultrasound (TUS) assessment in     patients undergoing talc pleurodesis via intercostal chest drain (ICD) for recurrent     symptomatic malignant pleural effusions (MPE). Participants will undergo TUS pre and post     pleurodesis on up to four occasions. We hypothesise that a TUS scoring system will be able to     predict short and long-term pleurodesis success earlier than current conventional medical     practice allows. This study may ultimately allow the proposal of a treatment algorithm to     manage patients with MPE in a more efficient manner.   "
50417|NCT02625662|"     This study will focus on the symptoms, natural history and clinical impact of     facioscapulohumeral muscular dystrophy (FSHD) in children.      Symptoms of classical FSHD start in adulthood. However, a small subgroup of FSHD patients     have an early, childhood onset. This early onset is associated with faster progression and     other symptoms like hearing loss and epilepsy.      The symptoms, natural history and clinical impact of FSHD in children are largely unknown.      The results of this study will be vital for adequate symptomatic management and     trial-readiness.   "
50418|NCT02625649|"     This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2     diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and     remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB.     Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular     complications such as nephropathy and retinopathy. Finally, the study provides insight into     the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota     diversity and bile acid levels.   "
50419|NCT02625636|"     Primary Objective:      To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC)     doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.      Secondary Objective:      To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of     SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.   "
50420|NCT02625623|"     The purpose of this study is to demonstrate superiority of treatment with avelumab plus best     supportive care (BSC) versus physician's choice (chosen from a pre-specified list of     therapeutic options) plus BSC.   "
50421|NCT02625610|"     The purpose of this study is to demonstrate superiority of treatment with avelumab versus     continuation of first-line chemotherapy.   "
50422|NCT02625597|"     The primary purpose of this study is to determine what effect, if any, do different dental     materials used to seal the prosthetic screw channels of implant supported restorations have     on dental implant health parameters and microbiology.   "
50423|NCT02625584|"     The aim of this project is to determine how shared reading promotes child language     development, and to use this knowledge to make it an effective language-boosting tool for     children from all social and economic backgrounds.   "
50424|NCT02625571|"     A significant minority of children (ages 5-12) display problematic sexual behavior and the     persistence of this behavior is oftentimes as stable as other child behavior problems, such     as aggression and defiance. Unfortunately, the only tested intervention protocols for these     concerns utilize a group treatment modality that is not feasible in most community treatment     settings. This project will define and pilot test an intervention for child sexual behavior     problems that is applicable in most settings and can be easily disseminated as a first step     toward validation in larger clinical trials.   "
50425|NCT02625558|"     Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary     hypertension   "
50426|NCT02625545|"     The purpose of this study is to evaluate the safety and effectiveness of using UroLift in     subjects with a prostatic median lobe enlargement due to BPH.   "
50427|NCT02625532|"     Exploratory, prospective, randomized, comparative, open trial with control group treated to     assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian     stimulation in women with Bologna criteria for poor ovarian response.   "
50428|NCT02625519|"     Exploratory, prospective, randomized, comparative, open trial with control group treated to     assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be     influenced by genotype of receptor N680S FSH Gene Polymorphism.   "
50429|NCT02625506|"     The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine     in the reduction of postoperative pain, postoperative opioid consumption after modified     radical mastectomy surgery.   "
50430|NCT02625493|"     The purpose of this study is to determine the preference of patients regarding the vascular     access site in future coronary procedures. We hypothesize that patients prefer the lesser     invasive procedure via radial access.   "
77346|NCT02273453|"     Study to determine the presence of a hang-over effect in healthy volunteers the day after the     administration of Songha® Night   "
50434|NCT02625441|"     This randomized clinical trial compares two systemic treatments for HER2-positive breast     cancer. The treatments are given either prior to breast surgery (as neoadjuvant treatment) or     after breast surgery (as adjuvant treatment). In the investigational group (Group A) the     study participants will receive a combination of two drugs directed at HER2 (two anti-HER2     antibodies) plus a chemotherapy agent (docetaxel) for a brief duration, and the patients     allocated to the comparator group (Group B) will be treated with chemotherapy plus one     anti-HER2 treatment (trastuzumab) for one year.   "
50435|NCT02625428|"     This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help     evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus     help direct the biopsy to the most abnormal part of the renal cortex. This should maximize     detection and increase the odds of demonstrating the true grade/severity of the     histopathological abnormality.   "
50436|NCT02625415|"     The study is designed to test the effectiveness of topical B6 cream in patients that     developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).   "
50437|NCT02625402|"     This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip     and knee osteoarthritis.   "
50452|NCT02625207|"     This will be an open-label, parallel group, multiple dose study in approximately 48 healthy     male or female subjects of African American and Caucasian self-reported race, to assess the     effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and     CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians     in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).   "
50453|NCT02625194|"     This study investigate the utility of continuous oxygen insufflation during fiberoptic     bronchoscope-guided intubation.      One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.      The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.      Then, the velocity of deoxygenation difference of PaO2(baseline   "
50438|NCT02625389|"     This study is multicenter (up to 10 sites in India) phase IV Post-Marketing Study. The study     is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical     glues used according to each site medical practice of vascular embolization. Subjects will be     enrolled with the main condition that a procedure of vascular embolization using Lipiodol®     Ultra Fluid in association with surgical glues is part of their therapeutic/palliative     strategy for their disease. The vascular embolization using Lipiodol® Ultra Fluid in     association with surgical glue will be administered as study procedure. According to the     patient need and health status a second vascular embolization using Lipiodol® Ultra Fluid in     association with surgical glue may be considered by the investigator within the next 30 days     after the first one. In this case, this procedure will be considered as a second study     procedure. The per-procedure safety evaluation will be enabled by appropriate records of     safety events during the time frame of the procedure of vascular embolization using Lipiodol®     Ultra Fluid in association with surgical glues. Safety evaluation will be completed with     safety records within 30 +/-3 days after the embolization procedure. Efficacy evaluation will     rely on the level of lesion(s) obliteration after embolization compared to the pre-procedural     target level of obliteration. Exploratory descriptive statistical methods will be used to     evaluate safety and efficacy, using both the total population and subsets of subjects with     similar clinical conditions.   "
50439|NCT02625376|"     This is an interventional, prospective, randomized, comparative monocentric study aiming to     evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative     Age-Related Macular Degeneration.   "
50440|NCT02625363|"     Glycemic index concept is widely used to determine impact of a food to blood glucose. Several     studies showed that water content and intake after meal may influence glycemic response of     the meal and thus have an effect on the result of GI measurement. Currently these studies     found conflicting results. Therefore, this study aims to determine whether water intake,     specifically after meal, may influence the glycemic response and glycemic index value of the     meal.   "
50441|NCT02625350|"     Glycemic index is commonly used as a method to determine the effect of a food to blood     glucose. Despite its carbohydrate and fat content, instant noodle is very popular in Asia,     including Indonesia. Based on the serving method, there are instant noodle without and with     soup. Studies have shown that water content of a meal may influence glycemic response of the     meal and thus have an effect on the result of GI measurement. However none specifically     studied instant noodles nor the additional water content as soup (not incorporated in the     food matrix). Therefore, this study aims to determine whether the serving method of instant     noodle (with and without soup) may influence the glycemic response and glycemic index value     of the meal.   "
50442|NCT02625337|"     This is a Phase 2 trial consisting of 24 patients receiving the combination of dabrafenib +     trametinib + pembrolizumab in 3 different dosing schemes and 8 patients receiving     pembrolizumab standard monotherapy. All patients start with pembrolizumab standard therapy     for 6 weeks and will then be randomized to continue pembrolizumab monotherapy or to receive     additional intermitted/short-term dabrafenib + trametinib.      Stratification will be baseline LDH level and baseline PD-L1 expression.   "
50443|NCT02625324|"     The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and     effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending     thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair. The Valiant Evo     International Clinical Trial is a first-in human experience with the objective to provide     clinical data for supporting CE marking via case series and descriptive statistics.   "
50444|NCT02625311|"     Randomized clinical trial comparing minimal invasive operating technique to conventional     operating technique for placement of total knee prosthesis.      Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these     two techniques.   "
50445|NCT02625298|"     Traumatic tooth injuries are common in children and adolescents, and often result in pulpal     necrosis and the development of periapical lesions. Treatment of traumatized teeth with     endodontic complications depends on the type of injury, number of injured teeth, root     development and patient cooperation, which altogether will create a challenge and dictate the     treatment plan for the dentist. The purpose of this study was to assess the effectiveness of     non-surgical root canal procedures in traumatized permanent teeth with necrotic pulps and     chronic periapical lesions using a tri-antibiotic paste and calcium-hydroxide as intracanal     medications and two different mineral trioxide aggregate (MTA) products for definitive     obturation.   "
50446|NCT02625285|"     This is a laboratory research to evaluate performances of quantitative POC G6PD tests     (Biosensors) against gold standard quantitative laboratory based tests and genotyping.   "
50447|NCT02625272|"     The purpose of this study was to determine the short and long outcomes of the novel     hand-assisted laparoscopic (HLA) right hemicolectomy with complete mesocolic excision (CME)     and no touch isolation.   "
50863|NCT02619838|"     The objective of this study is to prospectively evaluate the mid-term results and     intraoperative and postoperative complication rate in patients who underwent double or triple     arthrodesis using CCS screws.   "
50448|NCT02625259|"     The purpose of this study is to evaluate the relative bioavailability of a new tablet     formulation of MLN1117 (NTM) compared to the MLN1117 Process B capsules (CTM) (Part 1), to     assess the effects of food on the oral bioavailability and pharmacokinetics (PK) of MLN1117     (Part 2), and to assess the effects of gastric pH-modifying agent on the PK of MLN1117 in     healthy participants (Part 3).   "
50449|NCT02625246|"     To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells     (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore     treatment efficacy   "
50450|NCT02625233|"     This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked     clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly     replacement contact lens (control). Each subject will be assigned randomly to either the test     or control lens to evaluate the long term safety and efficacy of the investigational contact     lens compared to the marketed contact lens over a period of six months of lens wear.   "
50451|NCT02625220|"     Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to     evaluate the visual acuity, rotational performance, lens fit, stability and subjective     characteristics of a senofilcon-based JJVCI investigational toric contact lens design.   "
50455|NCT02625168|"     The investigators prospectively evaluated in this study the efficacy and safety profiles of     afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and     first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program     (CUP), with comparison of our historical cohort who received erlotinib after previous failure     to systemic chemotherapy and first-generation EGFR-TKI.   "
50456|NCT02625155|"     The purpose of this study is to determine whether the addition of selective pharmacogenomic     (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced     by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following     enrollment.   "
50457|NCT02625142|"     The goal of this study is to develop, implement, and evaluate the effectiveness of an     intervention designed to facilitate family engagement during bedside rounds at a children's     hospital. The intervention consists of a checklist of key behaviors associated with the     delivery of quality family-centered rounds, as well as training in the use of the checklist     tool. In a pre-post controlled design, two hospital services will be randomized to use the     checklist while two others will be randomized to usual care. The intervention is expected to     increase to the performance of key checklist behaviors, family engagement, and family     perceptions of patient safety.   "
50458|NCT02625129|"     This study will evaluate the clinical effectiveness of, and patient satisfaction with,     pre-travel consultations provided by a pharmacist with specialty training in travel medicine     and the authorization to prescribe medications and administer vaccinations.   "
50459|NCT02625116|"     The objective of the ELENA French Cohort is to study the developmental trajectories of     children and adolescents with ASD and their risk or protective associated factors.      This is an open, prospective and multicenter cohort study, including children and adolescents     under 16 years of age with ASD recruited from services specialized in the assessment of     developmental disorders.   "
50460|NCT02625103|"     The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated.     Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.      The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine     within the range of 10-14 hours after the last administration of clozapine .   "
50462|NCT02625077|"     This monocenter randomized controlled trial aims to compare postoperative outcomes of a     laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum     hiatal hernia of 3cm. In addition, an economic evaluation of the new intervention will be     done in order to determine cost-effectiveness and costs per quality-adjusted life-year     (QALY).   "
50463|NCT02625064|"     The goal of this project is to find a series novel biomarkers by differential proteomic     techniques that can improve the early diagnosis and develop a more efficient therapy to     enhance ARDS patient survival rate.   "
50464|NCT02625051|"     This is a prospective randomized study, comparing quality of life in renal stone patients     undergoing surgical treatment with ureteroscopy (URS) versus percutaneous nephrolithotomy     (PNL).   "
50465|NCT02625038|"     Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies     that are performed with patient-specific instruments.      Due to the higher accuracy achieved it is expected that complaints can be resolved or     effectively revealed. The Research hypothesis to prove is The medical product permits the     surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus,     carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and     2º. Secondary outcome is an assessment of the surgical outcome using the Disabilities of the     Arm, Shoulder and Hand (DASH) and the Patient related wrist Evaluation (PRWE) scores.   "
51734|NCT02608450|"     The primary objective of this study is to determine the safety and efficacy of CB-03-01     cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial     acne vulgaris.   "
50466|NCT02625025|"     During laparoscopy pneumoperitoneum creates the necessary space in which to perform the     operation. Growing evidence in general surgery has shown that reduction of intra-abdominal     pressure during laparoscopy is related to improved postoperative outcomes, decreased pain     perception, length of hospital stay, and analgesic rescue dosage in patients undergoing     minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with     standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and     feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal     pathologies.   "
50467|NCT02625012|"     Vitiligo is the most common acquired depigmented disorder of the skin characterized by     destruction of melanocytes resulting in well-circumscribed achromic macules. Ultraviolet     phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice, because     it is able to induce proliferation, differentiation, maturation and migration of melanocytes.     This repigmentation has distinctive patterns such as follicular, marginal, and diffuse. The     aim of this study is to observe the dynamics of migration and proliferation, in vitiligo     patients under UVB radiation phototherapy treatment. The investigators will evaluate this     process by measuring FAK (focal adhesion kinase ) and c-Kit by immunohistochemistry and     reverse transcriptase polymerase chain reaction assay.   "
50468|NCT02624999|"     Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine     (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .   "
50469|NCT02624986|"     This is a open-label, mutlicenter, non-randomized, study to evaluate the safety, efficacy,     and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R     FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an     initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is     designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with     obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is     designed to further assess the safety and efficacy of obinutuzumab in combination with     idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of     rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.   "
50510|NCT02624440|"     This study evaluates the effect of prophylactic antibiotics in multiple myeloma. One third of     patients will received treatment with clarithromycin, one third of patients will receive     treatment with sulfamethoxazole/trimethoprim and one third will be observed without     prophylactic antibiotics. All patients receive concurrent anti-myeloma treatment.   "
50470|NCT02624973|"     Breast cancer is an optimal model disease for studying personalized medicine. Breast cancer     was the first malignancy for which a predictive factor forecasting response to therapy was     identified nearly 50 years ago; the expression of the estrogen receptor (ER). Furthermore,     breast cancer is by far the malignancy in which prognostic and predictive factors have been     most extensively studied. Primary medical treatment (pre-surgical medical therapy) offers a     unique setting to explore predictive factors due to the fact that primary breast cancers are     easily accessible to repeated tissue sampling and evaluation of therapy response both     clinically and radiologically. For many years, the investigators have studied predictive     factors in primary medical treatment of breast cancer. In the present project, the     investigators will implement a new trial concept where the current knowledge from previous     trials with respect to predictive markers (hormone receptors, HER2; TP53, CHEK2 and RB1),     will be combined with massive parallel sequencing (MPS). Thereby, the investigators aim to     design the next-generation primary medical treatment where 1) therapy regimens are     individualized based on a limited number of known predictive factors and, 2) MPS is used to     explore additional predictive factors and their co-regulators in order to fully identify the     mechanisms of drug sensitivity / resistance across individual tumours and pave the way for     further personalized breast cancer therapy in the future. As for the new era of genomic     medicine, the current trial concept will allow individual tumours to be characterized by     their unique gene mutation / epigenetic modification profile upfront, to allocate patients to     their optimal personalized medicine as compared to classical drug testing through phase     II/III trials.   "
50471|NCT02624960|"     This is a single-arm, multi-center, open-label controlled study that will assess the safety     and performance of the Accucinch System to induce left ventricular reverse remodeling and     reduce the severity of functional mitral regurgitation in symptomatic adult patients with     mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic     or non-ischemic etiology), who are of high operative risk.   "
50472|NCT02624947|"     The purpose of this study is to determine the efficacy of maternal immunization with the RSV     F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia     through the first 90 days of life in infants.   "
50473|NCT02624934|"     Aortic stenosis is a major cause of morbidity around the world. Progressive aortic stenosis     leads to cardiac hypertrophy as a compensatory response. A maladaptive response may lead to     heart failure at varying degrees of severity of aortic stenosis in individual patients. The     predicting factors for the occurrence of a maladaptive response are not well defined.     Therefore current medical therapy for aortic stenosis is considered insufficient and may     actually cause harm. The only effective therapy for severe, symptomatic aortic stenosis is     aortic valve replacement. It has been found in an experimental study that Podocan determines     the degree of cardiac hypertrophy in response to pressure overload via the Wnt-pathway. The     possible prognostic role of secreted circulating Wnt modulators in aortic stenosis has also     recently gained attention. This project will attempt to establish the prognostic role of     circulatory Podocan and Wnt modulators for maladaptive left ventricular response to aortic     stenosis. This may help identify patients at particular risk to develop left ventricular     dysfunction with aortic stenosis and improve understanding of the mechanisms of left     ventricular remodeling in aortic stenosis. Hence, this may also later act as an important     background in finding more effective therapies to prevent or delay maladaptive left     ventricular response in aortic stenosis.   "
50494|NCT02624648|"     Objective: To study the effects of Lepidium Meyenii in sexual function of postmenopausal     women.      Method: It will be held a clinical, prospective, randomized, double-blind, placebo-controlled     study with 144 postmenopausal women with sexual dysfunction, treated at Menopause Clinic at     the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai     University. All women sign the Consent Form Term. The study will be conducted in accordance     with the protocol and principles of the Declaration Helsinki (Version 1996), according to     International Conference on Harmonization and Tripartite Guidelines for good clinical     practice and regulatory requirements. The protocol was approved by the Ethics Committee of     the Faculty of Medical Sciences of Santa Casa de São Paulo.      Hypothesis: It is expected to be an improvement of sexual function in postmenopausal women.   "
50474|NCT02624921|"     The study aimed to explore therapeutic effects of natural environments. To do so, the     investigators evaluated the immediate and sustained changes in several indicators of     well-being while people (n=26) with poor mental health were engaged in unconstrained     exposures to natural (green, blue) and urban environments. The indicators included:     affection, cognition, physiological responses.      Each participant was exposed to all environments for a period of 210 minutes between October     2013 and January 2014. During the exposure period, participants were instructed to do what     they would usually do in that environment. Before, during (at 30 and 210 minutes) and after     each exposure, several psycho-physiological measures were taken: (i) heart rate variability     and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure     monitor, (iii) physical activity using the CalFIT application installed in a Smartphone, (iv)     lung function using a portable computerized spirometer, (v) stress level using salivary     cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social     interactions using questionnaires, (vii) cognitive functioning using the backwards digit-span     task test.   "
50475|NCT02624908|"     24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy     of canagliflozin as compared with placebo in reducing the need for mealtime insulin in     subjects with type 2 diabetes currently using a basal-bolus insulin regimen.   "
50488|NCT02624726|"     Investigators propose to study the combination of m FOLFIRI plus Aflibercept in a Phase II     trial of patients with metastatic colorectal cancer. The promising results of aflibercept     derived from preclinical studies and from clinical trials conducted in patients with     refractory of recurrent to oxaliplatin-based 1st line treatment in patients with mCRC open     the field to explore such therapeutic approaches in the 1st line setting in combination with     the FOLFIRI regimen.   "
50511|NCT02624427|"     The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry,     Dynamic Contour Tonometry, and the Corvis ST tonometer.   "
50476|NCT02624895|"     This is a national, multicentric, prospective, observational trial. The decision to prescribe     FOLFOX plus panitumumab or FOLFOX plus cetuximab must have been freely taken by the clinician     prior to the study entry for each patient included. Each physician will see his/her patients     within the context of routine visits, without any special visit being organised for the     purposes of the study. Therefore, the doctor-patient relationship and patient follow-up are     not modified. Physicians are totally free to decide on their patients' therapeutic     management.      EORTC QLQ-C30 and DLQI questionnaires will be completed by the patients at baseline (Day 1 of     Cycle 1), at the first day of every other cycle (every 2 weeks) thereafter, and at end of     treatment visit (28 days (+/- 3 days) from the last cycle). Questionnaires should be     completed at the start of the visit, before any study related procedure is done.      Before every cycle, adverse events will be recorded and graded according to NCI CTCAE v4.0.     Treatment's modifications in terms of cycles' delay, dose reductions or drugs' interruptions     will be recorded.      Concomitant approaches to prevent or treat dermatological toxicities during the treatment     will be registered.   "
50477|NCT02624882|"     Single-center prospective study to assess the clinical course of group A streptococcal     blistering distal dactylitis in children after antibiotic treatment.   "
50478|NCT02624869|"     To describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab (AMG 145)     when added to standard of care in pediatric subjects 10 to 17 years of age with HeFH or HoFH.   "
50479|NCT02624856|"     The purpose of this study is to compare the efficacy and duration of pain relief after total     knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus     standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps     sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal     bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to     discharge readiness.   "
50480|NCT02624843|"     To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5%     with Ulesfia Lotion 5% in eradication of head lice in the study subjects.   "
50481|NCT02624830|"     The purpose of this study is to investigate long term response of sulfonylurea and glucose     control in children with diabetes due to mutations in ABCC8 that have been switched from     insulin injections to sulfonylurea tablets.   "
50482|NCT02624817|"     The purpose of this study is to investigate long term response of sulfonylurea and glucose     control in children with diabetes due to mutations in KCNJ11 that have been switched from     insulin injections to sulfonylurea tablets.   "
50483|NCT02624804|"     This is a prospective, single arm, open-label, single-center pilot study to assess the     safety, feasibility, and efficacy of Stem Cell Educator therapy for the treatment of patients     with Type 1 Diabetes.   "
50484|NCT02624791|"     Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with     respect to driving is unknown, but it could threaten safe operation of a motor vehicle,     especially under conditions such as nighttime driving when visual abilities are highly     challenged. This study measures driving-specific visual abilities and simulated driving     performance in participants with astigmatism who either have or do not have their astigmatism     corrected. The primary hypothesis is that at a tactical level, contact lenses correcting for     astigmatism will result in safer driving performance overall. The secondary hypothesis is     that at an operational level, contact lenses correcting for astigmatism will result in better     driving-specific visual performance.   "
50485|NCT02624778|"     The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the     safety of LY3002813 by looking at adverse events (side effects). The study will also look at     the effect the body has on LY3002813. Study participants will have mild cognitive impairment     (MCI) due to AD or mild to moderate AD.      The study involves 3 parts.        -  Part A in which participants will receive a single dose of LY3002813 or placebo (no          drug).        -  Part B in which participants will receive multiple doses of LY3002813 or placebo for 24          weeks.        -  Part C in which participants will receive multiple doses of LY3002813 or placebo for up          to 72 weeks.      Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C,     the study will last approximately 72 weeks, not including screening of approximately 56 days.     The study is for research purposes only and is not intended to treat any medical condition.   "
50495|NCT02624635|"     The purpose of this study is to compare the effects of manual therapy and of manual therapy     associated with hip strengthening in the recovery of patients with heel pain.      Heel pain decreases function, balance, walking and can cause change in the movement pattern.     This alterations can induce a deficit in motor control of other structures as knee and hip.     There is an importance to compare the effects of manual therapy and manual therapy associated     with hip strengthening on the recover of patients with heel pain.   "
51802|NCT02607566|"     This study will examine the feasibility and acceptability of a twice weekly yoga program for     adults with type 2 diabetes. Changes in perceived stress, salivary cortisol, and HbA1c will     also be examined.   "
50486|NCT02624765|"     Few studies are specifically designed to address health concerns relevant during pregnancy.     The consequence is a lack of evidence on best clinical practice. This includes mothers and     their babies when pregnancy is complicated by an abnormally fast heart rate up to 300 beats     per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby (fetus). Although     fetal SVA, including atrial flutter (AF) and other forms of supraventricular tachycardia     (SVT), is the most common cause of intended in-utero fetal therapy, none of the medication     used to date has been evaluated for their effects on the mother and her baby in a randomized     controlled trial (RCT). As a consequence, physicians need to make decisions about the     management of such pregnancies without any evidence from controlled trials on drug efficacy     and safety and no consensus among specialists for the optimal management. The Fetal Atrial     Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center     trial that addresses this knowledge gap to guide future fetal SVA therapy to the best of     care. Study components of FAST include three prospective sub-studies to determine the     efficacy and safety of commonly used transplacental drug regimens in suppressing fetal AF     without hydrops (RCT A), SVT without hydrops (RCT B), and SVT with hydrops (RCT C). All RCTs     are open label phase III trials of standard 1st line therapy, which either is started as     monotherapy (no hydrops) or as dual therapy (hydrops). The primary study aim is the     probability of a normal pregnancy outcome after treatment start with Digoxin or Sotalol (AF     without hydrops); Digoxin or Flecainide (SVT without hydrops); and Digoxin plus Sotalol or     Digoxin plus Flecainide (SVT with hydrops). The study also includes the possibility to enroll     non-randomized subjects into a prospective Registry to document the outcome of alternative     management.   "
50487|NCT02624752|"     The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral     Nutritional Supplement (ONS) on physical function and functional performance in malnourished     elderly patients.   "
50489|NCT02624713|"     Randomized Clinical Trial, the research will be composed of two parts in order to examine the     research question: a combination of controlled randomized retrospective research and     prospective cohort research      Prospective Cohort Research:      The research groups - families coming for treatment in Active Maccabi clinics in the     Northern Region, Israel. Approximately 30 families.      Retrospective Random Controlled Research        1. The research group - families that have completed an intervention program of Active          Maccabi Northern Region, Israel,within the past two to three years. The families will          be requested to attend a follow-up meeting of all family members in which they will          answer questionnaires. Approximately 66 families.        2. The control groups - families who did not participate in the program who have a child          between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), in          correlation with the child in the intervention group. Approximately 66 families.      Hypotheses of the research:        1. Status of the weight of the child being treated and of his siblings will be higher than          that at the end of the program.        2. Indication of the obesogenic environment of families participating in the program will          be lower in comparison with families not participating in the program.        3. The rate of eating disorder symptoms among children who participated in the program will          be lower in comparison with those of the obese/overweight child in families who were not          the program.        4. The rate of eating disorder symptoms among siblings who participated in the program will          be lower than that of siblings in families not in the program.   "
50490|NCT02624700|"     This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and     sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC).     Candidate pharmacodynamic and predictive biomarkers will also be evaluated.   "
50491|NCT02624687|"     This study will test the effects of a sedentary behavior intervention on low back pain in     working adults. The behavioral intervention will include the use of a sit-stand desk and a     wrist-worn activity prompter that will notify participants when they have been sedentary for     too long.   "
50492|NCT02624674|"     Peripheral vascular disease (PVD) is a common disease of impaired blood flow resulting in the     compromised tissue perfusion of lower limbs. PAD patients can experience pain, diminished     exercise capacity, and tissue loss, with some ultimately requiring amputation. The economic     burden of PVD is significant. In the United States alone, PVD accounts for over $20 billion     in annual healthcare related costs.      The demand for the development of an effective method to characterize the viability of PVD     wounds has resulted in the emergence of several innovative techniques. Commonly used     diagnostic methods are ankle-brachial index (ABI), pulse volume recordings, duplex     ultrasonography, venous plethysmography, Transcutaneous oxygen tension (TcPO2), toe     pressures, angiography by X-ray, computed tomography, and magnetic resonance imaging.     Currently, angiography remains the diagnostic gold standard. However, many of these     techniques lack the ability to triage and adequately determine the viability of the wound. In     addition, there remains a need for effective triage technologies to help clinicians decide     whether surgical management is needed. Early determination of surgical versus conservative     management may help to improve patient functional outcomes, reduce mortality rates, and     prevent limb amputation.      Near-infrared point spectroscopy (NIRS) is a non-invasively technology with recent     applications in PVD wound assessment. To date, studies have demonstrated the validity of NIRS     technology in patients with peripheral arterial disease. NIRS measures flow, concentration,     and oxygenation of hemoglobin in arterioles, capillaries, and venules several centimeters     deep in tissue. The MSID is an evolution of existing NIRS imaging devices and has become a     portable and functional commercial device produced by KENT imaging (Calgary, Canada). Using     this new and clinically applicable NIRS technology designed for assessing wound perfusion and     oxygenation, this study seeks to adequately identify viable from non-viable wounds and to     rapidly determine indication for vascular interventions. This technology is well-suited for     use in a wound patient population as the measurements times are short and can quickly be used     at the patient bed side. As such, this project intends to apply NIR technology to quickly     assess PVD in the investigators' patient population.   "
50493|NCT02624661|"     Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have     enough effect with the available pharmaceutical treatments and are offered a type of surgery,     which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The     researchers will do a pilot study on 10 patients with a new surgical technique using     neuronavigation. The researchers believe that this new neuronavigation-based system can     improve the precision of the technique and reduce the risk for complications.   "
50496|NCT02624622|"     Studies in several countries with a high rate of death of infants during the first week of     life have found a reduction in infection and mortality when chlorhexidine is applied to the     umbilical cord stump by a health worker within 24 hours of birth. This study will evaluate if     providing chlorhexidine to pregnant women during a prenatal care visit for application to the     cord stump after birth will be as effective for preventing omphalitis (infection of the     umbilical cord stump) as sending a community health worker into the home to apply the     chlorhexidine.   "
77347|NCT02273440|"     To evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single     dose of theophylline.   "
50497|NCT02624609|"     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak     concentration usually after 30 minutes. When the body senses the increase in blood glucose, a     hormonal process involving insulin takes place to ensure that the glucose is taken up from     the blood for storage and where it is needed for energy in the body. This process then brings     about a decrease in the concentration of glucose until it reaches approximately the starting     concentration. The original concentration of glucose is attained approximately 2 hours after     eating or drinking a carbohydrate food or sugary drink respectively in healthy people.      Different carbohydrates and sugary drinks have different effects on blood glucose response     depending on the amount as well as the type of carbohydrate. Those that give rise to a high     glucose response compared to a reference carbohydrate (usually glucose) are said to be high     glycaemic index (GI) foods and those with a lower glucose response compared to a reference     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.      Research has shown that diets that give rise to a high glucose response are associated with a     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly     comprises of insulin resistance and glucose intolerance which gives an increased risk of type     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)     rather than rapidly (high GI) have health benefits which include reducing the risk of     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can     lower the blood glucose levels.      This research will determine whether the presence of polyphenols in the diet has any lowering     effect on the blood glucose levels and hence the glycaemic index of foods. This will be     determined by asking volunteers to consume commercially available food supplements together     with white bread and then determining the glycaemic response. The blood glucose response of     bread will be determined initially as a control reference. All will be consumed in random     order.      Analysis will be done by measuring blood glucose response after consumption of the control     reference meal and the test meal containing polyphenols and then determining the incremental     area under the glucose curve.   "
50498|NCT02624596|"     The purpose of this study is to understand how ketamine brings about rapid improvement in     Obsessive-Compulsive Disorder (OCD) symptoms.   "
50499|NCT02624583|"     Ramadan fasting (RF) has been shown to be associated with vascular and metabolic disorders     including glycemic control and lipid profile. It may also alter pharmacologic properties of     some medications. Many patients with CAD and under Clopidogrel insist to observe the fasting     and taking the risk of altering the pharmacologic proprieties of this drug.      The aim of this study is to assess the effects of RF on clopidogrel resistance in patients at     high cardiovascular risk with particular interest to patients with DM.   "
50500|NCT02624570|"     The purpose of this study is to provide access to Midostaurin and gather additional safety     data on the combination of Midostaurin and standard of care for adult patients with newly     diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who     are eligible for standard induction and consolidation chemotherapy.   "
50501|NCT02624557|"     To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic     impairment compared to matched healthy control subjects.   "
50502|NCT02624544|"     Proton pump inhibitors act in blocking acid secretion and also have antioxidant and     anti-inflammatory properties. For that mechanisms possibly PPIs may have an anti-inflammatory     action with improvement in skin lesions in patients with psoriasis.   "
50503|NCT02624531|"     Patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will     be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph     node metastasis, involvement of lower part of uterus and endometrial carcinoma.If there is no     macroscopic tumor and no obvious disease in MRI,simple trachelectomy (ST) + sentinel lymph     node biopsy (SLNB) / retroperitoneal lymph node dissection(RPLND) will be performed.     Otherwise,two to three cycles of neoadjuvant chemotherapy (NACT) will be administrated and     then different fertility-sparing surgery(conization,ST or radical trachelectomy(RT) +     SLNB/RPLND) will be employed depending on the tumor size.   "
50504|NCT02624518|"     This phase II/III trial studies how well gallium (Ga) 68-labeled gastrin-releasing peptide     receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic     resonance imaging (MRI) works in detecting prostate cancer in patients with negative computed     tomography (CT) scan and elevated prostate-specific antigen levels after treatment with     surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and combine     them into a single picture and is used to describe information regarding the function, as     well as location and size of a tumor. 68Ga-RM2, a compound made of a radioactive agent linked     to a pharmacological substance that is strongly attracted by a substance made by tumor cells,     to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to see smaller tumors than the     standard of care contrast-enhanced CT or MRI scan   "
50505|NCT02624505|"     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test     product to the reference product, using bronchoprovocation (methacholine challenge testing)     in adult patients with stable mild asthma.   "
50506|NCT02624492|"     Part 1 (Phase Ib)      Primary objective:      To establish the maximum tolerated dose (MTD) of BI 836826 in combination with GemOx.      Secondary objectives:      To evaluate pharmacokinetics of BI 836826 when given in combination with GemOx and to     investigate preliminary efficacy in terms of the overall response rate based on     investigator's assessment.      Part 2 (Phase II randomized)      Primary objective:      To investigate the efficacy by means of the overall response rate (PR+ CR) based on central     review assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to     R-GemOx.      Secondary objective:      To investigate the efficacy by means of the complete remission rate based on central review     assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to RGemOx.   "
50507|NCT02624479|"     Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of renal     calculi could be a future indication for sodium thiosulfate (STS). Using an oral formulation     might increase the compliance and treatment success compared to parenteral administration.      Three gastro-resistant formulations of STS for oral administration were developed with     different release characteristics: fast-release, medium-release and slow-release tablets. Aim     of the enteric coating was to increase the oral bioavailability of STS. The bioavailability     and tolerability of these formulations for oral administration in healthy volunteers will be     compared in this clinical trial.   "
50524|NCT02624258|"     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously     administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen     receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains (referred to     as RNA CART19) in Hodgkin Lymphoma (HL) patients. Subjects will be treated with IV     administration of RNA anti-CD19 CAR T cells for a total of six doses over 3 weeks.   "
50525|NCT02624245|"     Assess pain, performance function, hip and knee strength and kinematics of trunk and lower     limbs during single leg hop test after movement control training associated to hip and knee     muscle strengthening.   "
50508|NCT02624466|"     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases     in childhood resulting in a lifelong need for health care, and a 3 times decreased life     expectancy. In addition, they have important comorbidities that negatively impact on their     quality of life and integration in society, jeopardizing their future even after a potential     transplantation. Retention of uraemic toxins is accepted to play a major role in the     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,     there are currently no good tools to evaluate severity and monitor adequacy of treatment,     resulting in suboptimal management.      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide the     clinician with new diagnostic and therapeutic tools for the management of children with CKD,     based on the improved understanding of uraemic toxicity.      In this first part of UToPaed, the investigators will associate concentrations of a wide     variety of uraemic toxins with different comorbidities in CKD children, i.e. growth,     protein-energy wasting, quality of life, cardiovascular risk factors, circadian rhythm, sleep     quality, and psychosocial and neurocognitive functioning (i.e. cross-sectional and     longitudinal). The toxins of which concentrations are best correlated with comorbidities     during the progress of CKD and eventually have representative kinetics (UToPaed - part 2:     Kinetic analysis) will be selected as markers. These markers will be, together with the     comorbidities, further tracked after interventions, i.e. starting on dialysis,     transplantation, changes in dialysis strategy (UToPaed - part 3 - intervention study).      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations     will be developed to optimise and individualise the dialysis therapy.      By providing clinicians with more advanced and appropriate tools to improve management of all     children with CKD, i.e. better assessment of the degree of renal dysfunction, better     determination of the ideal time to start renal replacement therapy, and more accurate     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and     psychosocial functioning (short term), growth, maturation into puberty, and social     integration (median term) and survival (long term).   "
50512|NCT02624414|"     Aims:        -  To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).        -  To compare the results of capsule colonoscopy with conventional colonoscopy in assessing          mucosal healing.        -  To correlate the level of faecal calprotectin with the results of capsule colonoscopy          and conventional colonoscopy.        -  To document changes in clinical practice attributable to the capsule colonoscopy          findings a) concordant with and b) in addition to the parallel findings at colonoscopy          and ileoscopy.      Project design: Cross sectional, prospective, comparative study      Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality     clinics with an established diagnosis of CD who need assessment of mucosal healing and have     consented to be part of the study will undergo capsule colonoscopy and conventional     colonoscopy on the same day after undergoing bowel preparation. The images of both the     conventional and capsule colonoscopies will be recorded. In addition calprotectin (an     inflammatory marker in faeces) will be measured in a sample of faeces collected by the     patients prior to the colonoscopy day.      Professor Macrae and the scholarly selective student researcher will assess the recorded     images obtained from capsule colonoscopies once the images have been deidentified.      To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD     (SESCD).      The results of the assessment of mucosal healing obtained from conventional colonoscopy will     be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be     correlated.   "
50513|NCT02624401|"     Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and     electroencephalography (EEG) studies will be carried out to reveal the neural correlates of     consciousness. Consciousness of the subjects will be manipulated with anesthetic agents     dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy     male subjects will be recruited to receive EC50 concentration of the anesthetic (40     dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being     imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and     metabolomics samples will be taken and analysed to find possible genetic factors explaining     the variability in drug response and to find chemical fingerprints of acute drug effect.   "
50514|NCT02624388|"     Toxicities related to pediatric cancer treatment can lead to significant illness, organ     damage, treatment delays, increased health care cost, and decrease in quality of life. Such     toxicities are largely due to tissue damage sustained by chemotherapy, and strategies     designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity     and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally     occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been     shown to reduce side effects of therapy in adult oncology clinical trials. This study will     examine the effect of genistein, the major isoflavone component in soybeans and the most     extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive     chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a)     30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy     Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein     daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have     fewer short-term therapy-related side effects during cycles of chemotherapy given in     conjunction with genistein supplementation than cycles given with placebo.   "
50515|NCT02624375|"     The purpose of this study is to learn more about the immune response to varicella zoster     virus (VZV).   "
50516|NCT02624362|"     An extended replication of Jaen & Dalton (2014), the investigators aim to investigate the     role of odors and associated trigger beliefs on symptom perception and airway inflammation in     individuals with asthma   "
50561|NCT02623777|"     During this project the investigators will evaluate whether the effects of arabinoxylan     oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic     syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the     investigators will evaluate whether changes in gut hormone production might explain the     effect on insulin resistance.   "
77348|NCT02273427|"     food effect, relative bioavailability, pharmacokinetics, safety and tolerability   "
50517|NCT02624349|"     The human papilloma virus (HPV) is known to be an important cause of cervical and anal     cancers. Studies on patients who have received a solid organ transplant (such as a liver or     kidney transplant) have suggested the risk of HPV-related cancers may be higher in this     population. The HPV vaccine, Gardasil®, has been approved for use in males and females by     Health Canada. In studies on healthy subjects this vaccine is nearly 100% effective at     preventing infections from HPV serotypes that are in the vaccine. These serotypes,     representing different viral strains, are known to cause 70% of cervical cancers and 90% of     genital warts. The vaccine was also shown to be very safe and well tolerated in healthy     subjects. Transplant patients are at higher risk of HPV related complications and cancers. As     a result transplant experts have recommended this vaccine for use in their patients; however     there have been no studies looking at the response to vaccination or safety of this vaccine     in solid organ transplant recipients. Our objective is to study the immune response and side     effects of Gardasil® in children who have received kidney or liver transplants. We will study     this by comparing immune responses to the vaccine in healthy adolescent females compared to     female liver and kidney transplant recipients. We will be recruiting females ages 12-19, as     the province of Ontario funds the vaccine for this group. We will evaluate the transplant     subjects for side effects after they receive the vaccine. Our hypothesis is that transplant     recipients will have lower immunogenicity than healthy controls.   "
50518|NCT02624336|"     Accumulation of dental plaque may result in negative effects on the tooth and tooth     supporting periodontal tissue. In addition, it contributes to the development of caries and     periodontal diseases. Therefore, an effective dental plaque control is essential for     maintaining good oral hygiene. Mechanical plaque control has its limitation thus chemical     plaque control may be used as an adjunct in dental plaque control. Various types of medicinal     plants can be utilized as stable, safe and biologically active plant-derived galenicals as     alternative to synthetic mouth wash. Among these plants, Salvadora persica L. (Sp) root     sticks and green tea (Gt) aqueous extracts were reported to have anti-microbial activity     against many oral bacteria. The objective of this study was to investigate the efficacy of     the combination of Gt aqueous extract and Sp aqueous extract as a synergistic anti-bacterial     and anti-adherence efficacy against primary plaque colonizers.   "
50519|NCT02624323|"     The main intention of this study is to compare two ultrasound-guided central venous     catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein     catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization     in terms of venipuncture, catheterization success, early mechanical complication and     catheter-related infection rate in mechanically ventilated patients admitted to the intensive     care unit.   "
50520|NCT02624310|"     The aim of this study is to increase norepinephrine levels in a population of young adults     where NE levels are very low or undetectable. In order to achieve this, the optimal dose will     be determined in a titration step. In the titration step, different doses of L-DOPS will be     tested in order to find the optimal and safest dose suitable for each individual enrolled in     the study. Because L-DOPS has never been used in the US in children or young adults, with     this titration step investigators will also determine the safest dose for this population.      Currently, L-DOPS is being used in our center to treat othostatic hypotension in autonomic     failure. The titration step for this study starts with the dose of 100 mg and increases in an     escalating manner up to a maximum of 600 mg a day (see investigational brochure attached).      L-DOPS has been developed in capsules for oral used and all the previous safety data has been     performed using this route. Oral route is the one that will used during study.      Carbidopa is well tolerated, safe in children and it has been used in this population in the     US without severe adverse effects.   "
50521|NCT02624297|"     The investigators hypothesize that chemoreflex response of muscle sympathetic nerve activity     (MSNA) during hypoxia and hypercapnia will be increased in coronary artery disease (CAD)     patients and that the presence of obstructive sleep apnea (OSA) will potentiate these     responses. And, that the exercise training would decrease the chemoreflex response of MSNA in     these patients.   "
50522|NCT02624284|"     Behaviors such as tobacco use, unhealthy diet, and sedentary behavior have far-reaching     health implications. These modifiable behaviors account for a substantial proportion of     deaths from cancer, cardiovascular disease and diabetes, and take a significant economic     toll. Yet, many unhealthy behaviors are very resistant to change, despite widespread     knowledge of the risks. Although theories of behavior change have been advanced to explain     the persistence of these behaviors, few consider the neurobehavioral underpinnings. These     approaches also fail to address a fundamental aspect of behavior change - an individual's     ability to exert sufficient self-control to overcome temptations for immediate gratification     and/or to maintain attention to long-term goals. With advances in the neuroimaging field, the     investigators are learning where and how self-control over decisions and behaviors is     executed in the brain. This work points to the central role of neural activity in the     dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy     choices. Further, emerging evidence shows that activity in the prefrontal cortices and     cognitive control circuits can be modulated using a noninvasive and safe intervention: direct     current transcranial stimulation (tDCS). The investigators pilot study, IRB study #820231,     demonstrated that a single session of 1mA tDCS increased the ability to resist smoking in a     validated smoking lapse paradigm. The current study will use a between-subject design to     investigate the dose/response relationship between tDCS (administered at 1mA, 2mA, or sham     stimulation for three sessions) and ability to resist smoking.   "
50523|NCT02624271|"     Despite the declining incidence, gastric cancer (GC) remains the second leading cause of     cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per     year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis     and intestinal metaplasia, have a high risk of developing GC. It is therefore important to     detect these pre-neoplastic lesions at an early stage to improve patients prognosis.      Thus, the aim of this project is to investigate the possible screening of gastric     precancerous lesions by a blood test (GastroPanel®) in France, in patients with     oesophagogastroduodenoscopy (EGD) prescription.   "
51248|NCT02615002|"     This study is a Phase 2, randomized, placebo controlled, dose ranging study of piromelatine     (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on     efficacy (cognitive performance), safety and tolerability in patients with mild dementia due     to AD.   "
50526|NCT02624232|"     Background Anorectal malformations(ARM) are rare and cover congenital defective development     of rectum.      ARM include a range of congenital conditions and may in varying degrees involve the     anorectum. A significant part have malformations in other organs mainly the urinary tract.      In the vast majority ARM are recognized at birth by lack of a normal anus. The primary     approach is construction of a stoma and subsequent reconstruction. Bowel continuity is     typical restored after 4-6 months.      Many patients experience abnormal bowel function later on and affected quality of life(QoL).      Aim      The primary objective is to assess the patient-related outcome 10-30 years after surgery for     ARM and to see if it related to existing damage to anorectum and bowel function. The     secondary objective is to identify problems with bowel function which may be treated     medically or by surgery to improve bowel function and QoL. To obtain the necessary knowledge     the study is divided in the following sub-projects:        1. Assessment of bowel function and QoL through relevant questionnaires        2. Examine sphincter anatomy and function through rectal ultrasound, magnetic          resonans(MR)-scan of the pelvis and anal manometry. Bowel function is assessed through          colonic transit time. Screening for urinary tract problems with uroflowmetry.      Methods Participants are identified through relevant diagnostic codes(Q 42) and patients     which underwent surgery for ARM in the years 1985-2005 are included if informed consent is     obtained.      Relevant questionnaires regarding symptoms and QoL are completed before the following     examinations:        -  Anal manometry        -  Anal ultrasound        -  Pudenda conduction velocity        -  Colonic transit time        -  Magnetic resonans(MR)-scan of lower abdomen and pelvis        -  Uroflowmetry      Bowel function and QoL is assessed in both children and adults with relevant validated     questionnaires.      Perspective No danish studies and only a few foreign investigate the relationship between     anatomy/physiology and quality of life after surgery for anorectal malformations.      The investigators believe the study and included comprehensive examinations will clarify the     causes of functional problems after surgery for anorectal malformations. Results of     questionnaires regarding symptoms, disease-specific-and general quality of life offer a     unique opportunity for targeted treatment to improve symptoms and QoL in patients with ARM.   "
50527|NCT02624219|"     This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant     females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility     criteria. This clinical trial is designed to assess the safety, reactogenicity, and     immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by     bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or     without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis     Vaccines and Diagnostics, respectively.   "
50528|NCT02624206|"     This is an etiology study designed to examine the how people's brains and behaviors respond     to regularly consuming a beverage. Participants are assessed at 2 behavioral assessments     (Wave 1 and Wave 2), 2 scans (at the BRIC), and at 9 'intervention' assessments (5-10mins)     different time periods throughout the study. At their first assessment (W1) they are     randomized into one of two juices.   "
50529|NCT02624193|"     Preliminary data from the investigators' NCCAM-funded R21 on mindfulness-based stress     reduction (MBSR) in HIV-infected youth suggest an association between mindfulness and     improved self-regulation and medication adherence. This randomized, controlled trial will     help the investigators to better understand the specific impact of MBSR on HIV medication and     treatment adherence in HIV-infected youth, and the efficacy of MBSR in the amelioration of     stress and improved self-regulation.   "
50530|NCT02624180|"     The investigators are studying whether an anti-inflammatory intervention improves impaired     coronary endothelial function (CEF) in HIV+ people with no clinical coronary artery disease     (CAD).   "
50531|NCT02624167|"     A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in     patients with chronic schizophrenia that are not responding adequately to their current     antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose     range of 15 to 25 mg, BID in a 1:1 ratio.   "
50532|NCT02624154|"     Investigator determined the factor of surgery associated with the survival of pancreatic     neuroendocrine tumor.   "
50533|NCT02624141|"     This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly     epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients     with solid tumors. The anticipated study duration is 4 months, and the target sample size is     40 individuals.   "
50534|NCT02624128|"     V-CHANCE is a phase 2, trial exploring the feasibility and the activity of valproic acid     (VPA) in combination with the standard cisplatin-cetuximab combination in patients with     recurrent/metastatic squamous cell carcinoma of the head and neck, never treated with     first-line chemotherapy. The study includes an explorative analysis of the potential     prognostic or predictive role of several biomarkers with the aim of improving the knowledge     of the mechanisms by which VPA enhances chemotherapy effect and of identifying early     predictors of treatment response/resistance.   "
50535|NCT02624115|"     Colorectal cancer (CRC) is one of the leading causes of cancer mortality in Canada. Rectal     cancers are now known to be hypoxic which is a negative prognostic factor and predictive of     metastatic spread and poor responsiveness to treatment. This has also been shown in     preclinical xenograft models. Hence there is a need for identification of hypoxic rectal     cancers.      In this pilot study the investigators intend to non-invasively assess the tumor and nodal     metastasis using an integrated Positron Emission Tomography-Magnetic Resonance Imaging     scanner (PET/MRI) with 18F-Fluoroazomycin Arabinoside (18F-FAZA) a radiopharmaceutical for     assessing tumor hypoxia. The hypoxic rectal tumors will show an increased uptake of 18F-FAZA     on PET which will have morphological correlation on MRI. The patient will then undergo     neoadjuvant chemoradiation therapy (CRT) followed by repeat 18F-FAZA PET/MRI and rectal     cancer surgery with pimonidazole staining. Pimonidazole is an extrinsic marker of hypoxia     that is selectively reduced and covalently bound to intracellular macromolecules in areas of     hypoxia within normal and tumor tissue with current approval for use in humans for research     studies.      The primary goal of this pilot trial is to validate FAZA-PET as a biomarker of hypoxia by     correlating its uptake in rectal tumors to pimonidazole staining in histopathology specimens.     If the investigators pilot study successfully demonstrates the uptake and correlation of     pimonidazole and FAZA-PET, the investigators would like to initiate a larger study examining     hypoxia in rectal cancer. The investigators aims would be to image patients with locally     advanced rectal cancer before CRT to ascertain whether high FAZA-PET uptake correlates with     poor outcome to CRT. The ability to preoperatively predict the patient sub-population that     will respond best to CRT, will help to identify the complete pathological responders and     avoid unnecessary surgery. Furthermore, the FAZA-PET high subset of patients may benefit from     other treatment strategies including clinical trials of anti-hypoxic agents.   "
50536|NCT02624102|"     Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world.     The treatments of choice are the psychotropic drugs of the class of antidepressants and     Behavioral or Cognitive Behavior Therapy (CBT). The aim of this study is to compare the     efficacy of Trial Based Cognitive Therapy with the Behavioral Activation and pharmacotherapy     in the treatment of MDD in a randomized clinical trial witch 96 patients with MDD,   "
50537|NCT02624089|"     The objective of this study is to assess whether the administration of nebulized     intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline, reduces     morphine consumption after laparoscopic appendectomy surgery in children and adolescents.   "
50582|NCT02623504|"     A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety     of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long     term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute     manic or mixed Bipolar I Disorder   "
50538|NCT02624076|"     Infertility affects one in six couples. In a quarter of them, routine tests of semen quality,     ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is     unexplained. Acupuncture is being increasingly used by couples with all types of infertility     and initial trials have suggested that it could be potentially beneficial in some cases. A     number of systematic reviews of acupuncture in IVF have shown conflicting results, but there     is no evidence to inform best practice in unexplained infertility. In addition, as an     intervention, acupuncture is not cost neutral as it involves multiple visits for treatment     sessions delivered by a skilled practitioner. Thus, while acupuncture could have the     potential to increase live birth rates in women with unexplained infertility, the clinical     and cost effectiveness of acupuncture needs to be confirmed in the context of a large     randomized controlled trial.   "
50539|NCT02624063|"     The purpose of the study is to study the combination of Sofosbuvir in Combination With     Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic     Hepatitis C Virus (HCV) Genotype 1.   "
50540|NCT02624050|"     Patient undergoing general anesthesia in elective surgery will be assigned to receive either     methohexital or propofol general anesthesia. Hypotensive events during the first 15 minutes     of induction will be compared between the groups to ascertain which drug is less likely to     cause a hypotensive event.   "
50563|NCT02623751|"     The primary objective of the open-label, dose-escalation study is to investigate the safety     of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female     subjects with advanced or recurrent breast cancer. The secondary objective is to investigate     the pharmacokinetics and efficacy.   "
50564|NCT02623738|"     The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic     solution compared to the placebo ophthalmic solution and to determine if intraocular pressure     reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to     latanoprost ophthalmic solution 0.005%.   "
50541|NCT02624037|"     The introduction of infliximab (IFX) and other monoclonal antibodies (MAbs) targeting tumor     necrosis factor (TNF) was a major advancement in the management of inflammatory bowel disease     (IBD). These biologics were able to improve the health outcomes of many IBD patients for whom     other treatments were neither satisfactory nor sufficient. Despite clear advantages and     increased use of these treatments, physicians still see a loss of response in up to 50% of     their IBD patients within one year of initiating these therapies. Most of these phenomena are     attributed to low drug concentrations in the presence or absence of anti-drug antibodies     (ADA).      The fundamental issue is that approved/on-label dosing of these drug therapies does not take     into account the various factors that impact the way an individual's body responds and     processes these therapies. Dashboard software systems can quickly integrate patient data and     serve as a revolutionary decision-support tool for physicians. The Precision IFX dashboard     prototype was specifically developed to facilitate dosing of therapeutic monoclonal     antibodies by integrating patient's clinical characteristics and drug concentrations into     pharmacokinetic (PK) algorithms. Using clinical observations and patient laboratories, the     system provides multiple dosing regimens that could allow the patient to attain and sustain a     therapeutic drug trough level.      Using the Precision IFX dashboard to analyze and forecast optimal dosing regimens with     prospectively collected individual patient data, the clinician will select an appropriate     dose to actively maintain therapeutic drug trough levels throughout the infliximab     maintenance period. This study aims to examine the outcomes of one year of maintenance     infusions in IBD patients dosed using the Precision IFX dashboard prototype and compare the     results with historical controls.   "
50542|NCT02624024|"     The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays     intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and     laboratory settings. The purpose of the study is to establish the clinical performance of the     AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.   "
50543|NCT02624011|"     This study will investigate the influence of increased sedentary time on long-term measures     of muscle protein synthesis and metabolic health. The investigators will test the hypothesis     that increased time spent in sedentary behaviours will lead to a reduction in long-term     measures of muscle protein synthesis and compromised metabolic health.   "
50544|NCT02623998|"     The purpose of the study is to determine whether in patients with early type 2 diabetes,a     short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal     insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in     achieving sustained diabetes remission.   "
50545|NCT02623985|"     The purpose of this study is to evaluate accuracy of rapid tests for group A beta hemolytic     streptococci in patients who presented with sore throat at out patient department in Siriraj     Hospital.   "
50546|NCT02623972|"     This research study is studying a drug called eribulin combined with standard treatment as a     possible preoperative treatment for HER2 negative inflammatory breast cancer.   "
50547|NCT02623959|"     The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in     combination with saline (the current standard of care) versus IPC in combination with     doxycycline as treatment for pleural effusions.   "
50548|NCT02623946|"     Study Design:      Phase 4, pilot, single center, observational study. MEP's will be obtained twice, two weeks     apart at baseline and every 6 months for 36 months (total of 14 sessions of MEP's)      MEP's will include:        1. Onset latencies and CMCT to bilateral abductor pollicis brevis and tibialis anterior          muscles        2. MEP amplitudes and the ratio of the central to peripherally obtained motor amplitudes          (MEP-M ratio) to bilateral abductor pollicis brevis and tibialis anterior muscles          Clinical measures (EDSS, MEP's, T25FWT, 6MWT, 9HPT) will be obtained at baseline and          every 6 months for 36 months.      Study location: Single center in Canada      Study Objectives:      Primary: To evaluate the reliability of MEP's in Alemtuzumab treated MS patients over a 36     month period.      Secondary: To determine the degree of correlation between MEP's and presently used clinical     measures of efficacy (EDSS, 6MWT, T25FWT, 9HPT) and to determine if MEP's can predict who     will require a third cycle of Alemtuzumab.   "
50549|NCT02623933|"     Radiation therapy plays an important role in the management of prostate cancer. In recent     years it has become evident that higher doses of radiation are required to optimize disease     control. The limiting factor of escalating dose to the prostate is the surrounding normal     tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of     patients most often at the site of the original primary disease. As such there is growing     interest in further dose escalating to the area of primary disease burden.The aim of this     work is to look at the feasibility and toxicities of an integrated focal boost to whole gland     prostate treatment using high dose rate brachytherapy.   "
50550|NCT02623920|"     This phase II trial studies how well brentuximab vedotin, bendamustine, and rituximab work in     treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of     improvement or has not responded to previous treatment. Monoclonal antibody-drug conjugates,     such as brentuximab vedotin, use antibody to target chemotherapy in cancer cells. Drugs used     in chemotherapy, such as bendamustine, work in different ways to kill cancer cells.     Monoclonal antibodies, such as rituximab, kill the cancer cells directly, but also harness     the immune system to kill the cancer cells. Adding brentuximab to rituximab may improve     response rates in CD30 positive, CD20 positive Relapsed Refactory NHL.   "
51249|NCT02614989|"     This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS     patients with disabling refractory tremor.   "
50551|NCT02623907|"     With the aging of Chinese population, degenerative valvular disease is becoming more and more     frequent, which has brought a heavy burden to our society. Taking aortic stenosis (AS) as an     example, the incidence of AS in population over the age of 65 are about 2%, and in population     above the age of 85 can be amounted to 4-8%, in the Western country. Since the invention of     transcatheter aortic valve replacement (TAVR),aortic valve disease (AVD),including AS and     aortic regurgitation (AR), has attracted more and more attention. To date, there are few data     about the prevalence of AVD in China. The characteristics and prognosis of AVD in China are     still unknown. Therefore, the investigators design a prospective, observational cohort study     to investigate characteristics, treatments and prognosis of AVD in Chinese elderly     population. The results of the study will provide a basis for the future national health     policy for prevention and treatment of AVD in the elderly.   "
50596|NCT02623322|"     This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in     otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety     and tolerability, efficacy, and pharmacokinetics of MHAA4549A.   "
50597|NCT02623309|"     Allogeneic (Allo) hematopoietic stem cell transplantation (HSCT) is a recognized curative     procedure for hematological malignancies. It is now well known that this property is related     to the graft-versus-tumor (GVT) effect developed from the immunocompetent cells contained in     or generating from the donor graft. For years, however, and despite this unique antitumoral     activity, Allo-HSCT has been restricted to a limited number of patients due to two major     limitations: the toxicity of the procedure and the absence of a donor for every single     patients. More recently the stage has dramatically changed with respect to these two     restraints. Over the last decade, many studies have established the feasibility of Allo-HSCT     in older patients but the availability of MRD is even less frequent in elderlies, likely     related to medical contraindication for graft donation or sibling deaths. UD are routinely     used but associated with a high incidence of GVHD. As compared to younger populations,     unrelated cord-blood HSCT is seldom performed in this population and numbers decrease with     age due to the feared risk of supposed increased lethal infectious complications related to     the effect of the delayed immune reconstitution in elderlies. Thus the need for alternative     donors allowing for a safe and efficient transplantation is still unmet. In consequence,     overall, despite the fact that Allo-HSCT feasibility has been established in the oldest     patients, all these lacks contribute eventually to maintain a low rate of allo-HSCT performed     in a population with the higher incidence of hematologic malignancies that usually present     with the poorest prognosis.      Thus it is critical developing innovative efficient therapeutic strategies answering this     unmet-medical need. In this perspective, Haplo-HSCT could represent a part of the answer in     this aged population. It offers the potential advantage to offer a rapid donor determination     for virtually every single patient. In addition, our data suggest that in elderlies     haplo-HSCT using T-repleted graft, RIC and PT-HDCy presents low NRM and retains an antitumor     effect despite low GVHD incidences. They also suggest that haplo-HSCT may conduct to better     outcome than URD-HSCT as an alternative to MRD-HSCT. It may also be associated with lower     costs (no graft purchase and low post-transplant complications rate) and better QOL likely     related to low cGVHD-rate. In addition the conduct of such trial at a time when the diffusion     of the strategy in this population is just starting is really crucial before widespread     uncontrolled dissemination.      The investigators propose to address this question by prospectively comparing these 2     strategies in elderly patients without MRD, in terms of efficacy, safety and including the     prospective evaluation study of quality-of-life (QOL). They will conduct a national,     multicenter, open-label, comparative, randomized phase III trial in patients with     hematological malignancies justifying an allo-HSCT from an alternative donor when a MRD has     not been identified.      When MRD search is recognized to be a failure, patients will be included in the clinical     trial after informed consent and randomized in the two strategies based on donor search:        -  Reference group: Unrelated Donor group        -  Investigational group: Haplo Donor Group      Investigators will use a composite end-point embracing the three main causes of failure:     death, relapse and severe cGVHD (as a surrogate endpoint for QOL). We will analyze the HSCT     usual objectives as GHVD, NRM, relapse and survival. A specific study of patients' health     related quality of life will also be conducted using the FACT-BMT questionnaire. In addition,     the success of the two strategies in term of transplant completion (donor determination,     transplant realization and time to do so) will be compared.   "
50552|NCT02623894|"     Introduction: The process of population aging that is occurring in developed societies     represents a major challenge for the health system. The aim of this study is to analyze     factors that have an influence on early vascular aging (EVA), estimated by carotid-femoral     pulse wave velocity (cf-PWV) and Cardio Ankle Vascular Index (CAVI), and to determine     differences by gender in a Spanish population.      Methods and analysis: An observational, descriptive, cross sectional study.      Study Population: From the population assigned to the participating Health Care centers, a     cluster random sampling stratified by age and gender will be performed to obtain 500     participants aged between 35 and 75. Those who meet the inclusion criteria and give written     informed consent will be included in the study.      Measurements: Main dependent variables: cf-PWV determined using Sphigmo Cor System and CAVI     estimated using VASERA. Secondary dependent variables: telomere length, carotid intima-media     thickness, central and peripheral augmentation index, ankle-brachial pulse wave velocity,     ankle-brachial index, retinal arteriovenous index, and renal and cardiac organ damage.     Independent variables: Lifestyles (physical activity, adherence to mediterranean diet,     alcohol and tobacco consumption); psychological factors (depression, anxiety, and chronic     stress); inflammatory factors and oxidative stress.      Ethics and dissemination: The study has been approved by the clinical research ethics     committee of the healthcare area of Salamanca. All study participants will sign an informed     consent to agree to participate in the study in compliance with the Declaration of Helsinki     and the WHO standards for observational studies. The results of this study will allow the     understanding of the relationship of the different influencing factors and their relative     weight in the development of EVA. At least five publications in first-quartile scientific     journals are planned.   "
50553|NCT02623881|"     To compare the effectiveness of cervical pessary (Arabin) and vaginal progesterone for     preventing premature birth in twin pregnancies after IVF   "
50554|NCT02623868|"     Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability     to CKD-519 new formulation in healthy male subjects.   "
50555|NCT02623855|"     The SHINE study is a randomized controlled study of the effect of a park-based family support     group on multiple outcomes (including stress and physical activity) in a low income     population.   "
50556|NCT02623842|"     Pilot study, case series conducted in women with a clinical diagnosis of urinary incontinence     and were treated with radiofrequency technique for capacitive transfer non ablative in     external urethral meatus. All participants did an hour Pad Test. The participants made five     sessions of Radio Frequency (RF) with an interval of seven days between them. The application     of RF was performed by physical therapist trained in the technique of radio frequency through     the Tonederm® brand device with capacitive transfer method using non-ablative handle with     electrode in the region of the external urethral meatro and coupling electrode placed on the     participant's back. For application, the participants were in gynecological position. The     session had an average duration of 20 minutes. The temperature was measured by an infrared     thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.   "
50557|NCT02623829|"     Dermatological surgeons wear many hats to care for subjects with skin cancer. While their     role in cancerous tissue removal results in superior cure rates, there is also a need for     skilled excisional repair and effective wound healing regimens so the subject can heal with     the least amount of scarring necessary. As such, numerous techniques have been developed for     reducing the morbidity associated with excessive scarring. Various flaps and grafts allow the     surgeon to approximate skin texture, thickness and adnexa with respect to the residual     surrounding tissue. However, for optimal cosmetic and functional outcome, specific suture     techniques are often necessary to ensure close wound approximation while simultaneously     minimizing static tension along the wound edge. In addition, there are post-operative     techniques for wound care that range from special dressings during the various stages of     healing to cosmetic procedures for scar modification. Unfortunately, once the operation is     complete, there is little the surgeon can do to minimize adverse scar formation without     impairing the healing process. To date, most surgical wounds are allowed to heal at least     partially before scar revision or modulation is attempted.      Botulinum toxin presents a unique opportunity for surgeons to affect scar formation     throughout the duration of the healing process. These effects are likely independent and     adjunctive to any and all wound care techniques, and are primarily attributed to a reduction     in dynamic tension on the wound edges. Most importantly, botulinum toxin's one time dosing     requirements with respect to reduced scar formation precludes the variance inherent to     standard wound care practices.      Therefore, it has been proposed that for selected subjects, botulinum toxin may be a safe,     effective and reliable means for improved post-excisional repair outcomes. Botulinum toxin     has been investigated as an inhibitor of excessive, post-excisional scar formation in plastic     surgery and Otorhinolaryngology literature. However, these promising studies have yet to     combine objective assessment measures of human scar formation in a randomized controlled     trial. In addition, there are currently no formal studies of botulinum toxin as a     prophylactic against excess scarring in the dermatological literature. Fortunately, Botulinum     toxin dosing in the forehead for the purposes of inhibiting excessive scar formation is     comparable to the amount given for cosmetic purposes, which is commonplace in dermatology and     well-studied.   "
50558|NCT02623816|"     The overall aim of this study is to assess if patients with persistent GERD symptoms     receiving sub-optimal omeprazole dosing experience improvement in GERD symptoms when     prescribed an optimal dosing regimen. The optimal dosing regimen is defined as taking     omeprazole 30 minutes prior to the first meal of the day.   "
50560|NCT02623790|"     Dairy products consumption is widely recommended in a healthy diet not only for bone growth     and maintenance, but also as a protein, calcium and magnesium sources for an adequate diet.     However, dairy products are a major dietary source of saturated fat that is associated with     increased risk of coronary heart disease. ln this context, dietary guidelines still advocate     a restriction in dietary saturated fat for optimal heart health. Nevertheless, the     association between saturated fat and the risk of heart disease remains highly controversial     within the scientific community. There is also emerging evidence that the impact of dietary     saturated fat will be significantly influenced by the food matrix through which it is     provided. Recent studies indicate that cheese could have a major influence on intestinal fat     absorption and the magnitude of the after meal release of fat in blood circulation. This is     of interest because substantial evidence exists indicating that elevated levels of the after     meal fat levels are associated with increased cardiovascular risk. Therefore, the improvement     of the after meal fat levels produced by cheese consumption could well be part of novel     therapeutic approaches contributing to improve cardiovascular risk.      The general objective of the proposed research is to investigate how cheese consumption     affects the after meal release of fat in blood circulation in healthy subjects. Our     hypothesis is that, compared to butter, cheese consumption will have a beneficial impact on     the after meal fat levels in healthy subjects. Favourable results from the proposed study     will provide novel and much warranted evidence on the importance of considering changes in     the after meal fat levels, not only bad cholesterol, as part of the on-going saturated     fat-heart disease debate and that cheese should indeed be part of a healthy diet.   "
51250|NCT02614976|"     Padding with cuff during blood pressure is expected to reduce number of skin crease or     petechiae incidence.   "
50562|NCT02623764|"     Drug treatment with cholinesterase inhibitors is indicated for treatment of Alzheimer´s     disease and in most cases, one of these drugs is prescribed as soon as the diagnosis has been     made. Nevertheless, it has been shown in several studies that up to 30% of patients do not     benefit from treatment. These drugs can have side effects, most frequently from the     gastrointestinal tract with nausea, diarrhea and discomfort in the abdomen as the most     frequent signs. It is therefore important to know before the treatment is initiated if the     patient will likely benefit from the drug or not. It is not possible today with current     knowledge but this project aims to evaluate a specific index, calculated from an EEG     registration (the EEG-cholinergic index) for this purpose. A conventional EEG registration is     done before treatment and the cholinergic index calculated from the EEG registration is     compared to the clinical outcome. The duration of follow up is 6 months with an extension of     further 6 months.   "
50565|NCT02623725|"     The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine     dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.      Primary Objective      - To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of     a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects     from previous CYD dengue vaccine trials.      Secondary Objectives:        -  If the primary objective of non-inferiority is achieved: To demonstrate the superiority,          in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue          vaccine injection in subjects from previous CYD dengue vaccine trials.        -  To describe the immune responses elicited by a CYD dengue vaccine booster and placebo          injection in subjects who received 3 doses of the CYD dengue vaccine in previous CYD          dengue vaccine trials.        -  To describe the neutralizing Ab levels of each dengue serotype post-dose 3 (previous CYD          dengue vaccine trials' subjects) and immediately prior to booster or placebo injection          in all subjects.        -  To describe the neutralizing Ab persistence 6 months, 1 year, and 2 years post booster          or placebo injection in all subjects.        -  To evaluate the safety of booster vaccination with the CYD dengue vaccine in all          subjects.   "
50566|NCT02623712|"     This study will compare two clinically accepted protocols for surveillance imaging in     individuals who are found to have a small pulmonary nodule on chest computed tomography (CT)     scans.   "
50567|NCT02623699|"     The primary objective of the study is to evaluate the safety, tolerability, and     pharmacokinetics (PK) of BIIB067 in adults with ALS. The secondary objective is to evaluate     the effects of BIIB067 on levels of superoxide dismutase 1 (SOD1) protein in the     cerebrospinal fluid (CSF).   "
50568|NCT02623686|"     It is known from the literature that patients in the Intensive Care Unit do not get enough     sleep impacting on short and longterm recovery (Tembo & Parker, 2009; Bihari et al, 2012;     Kamdar et al, 2012). The use of non-pharmacological interventions such as massage with     essential oils is supported by the literature as being useful in encouraging sleep (Richards     et al, 2003; Matthews, 2011). Over 30% of cancer patients are accessing complementary     therapies such as these (Rees et al, 2000; Lewith et al, 2002). We propose investigating     whether aromatherapy massage and the use of essential oils in the form of an Inhalation Patch     (Bioesse TM) prove to be a useful intervention for improving patient sleep whilst on the     critical care unit.   "
50569|NCT02623673|"     Retrospective cases series is a non-randomized, open-label, single-center investigation     (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to     diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous     treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone     0.7mg.   "
50570|NCT02623660|"     The purpose of this study is to determine if patients undergoing a total knee arthroplasty     (TKA) experience a clinically significant reduction in healing time when treated post     operatively with a specific form of micro and nano-ampere current. The results of this trial     will provide a basis for generalizing its outcomes to apply to other joint replacements and     revisions by reducing edema and inflammation and therefore will result in a shorter time to     heal.      The study will compare electrically treated and non electrically treated patients by using     digitally based measurements to determine objective reductions of lower extremity edema     including intra and inter cellular shifts in fluid distribution, increased range of motion     (ROM) and muscle strength, and improved functional tests of ambulation.   "
50571|NCT02623647|"     The present is a phase I-II study testing the safety and the efficacy of extremely     hypofractionated radiotherapy for early stage prostate cancer. The study is designed to     assess GU toxicity while controlling tumor control, in terms of survival free from     biochemical failure. 40 Gy in fxs will be delivered to patients with low and favourable     intermediate risk prostate tumors.   "
50572|NCT02623634|"     the purpose of this study is to analyzes the factors influencing the results of cuff leak     test, in order to improve the cuff leak test on the accuracy of the prediction on airway     edema after extubation.   "
50583|NCT02623491|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     JNJ-55375515 in healthy participants after administration of single and multiple oral doses.   "
50584|NCT02623478|"     This study evaluates a new test formulation of a glucose lowering drug, insulin lispro,     delivered by an insulin pump continuously under the skin. The study will be conducted in     participants with type 1 diabetes mellitus to investigate how the human body processes the     new test formulation and its effect on blood sugar levels when it is delivered via an insulin     pump. Side effects and tolerability will be documented. The study will last about 4 to 11     weeks, including screening, lead-in and follow up. Screening is required within 28 days prior     to entering the study.   "
51251|NCT02614963|"     Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome   "
50573|NCT02623621|"     A growing amount of reports has consistently evidenced that a sustained inhibition of the     angiogenesis is an effective therapeutic strategy, able to improve the outcome of metastatic     colorectal cancer (mCRC) patients.      In the last decade different biologic agents targeting angiogenesis have been approved for     the treatment of mCRC, such as bevacizumab, aflibercept and regorafenib, and, more recently,     solid evidences have demonstrated the efficacy of a sustained antiangiogenic approach even     beyond the first progression to a bevacizumab-containing regimen. In particular, two phase     III randomized trials proved the effectiveness of prosecuting bevacizumab in second-line     switching the chemotherapeutic regimen in patients already treated with bevacizumab in     first-line. Preliminary experiences evidenced that circulating levels of angiogenesis-related     markers are significantly modulated during first-line chemotherapy plus bevacizumab. In     particular, a wide variability of plasma soluble Vascular Endothelial Growth Factor     Receptor-2 (VEGFR-2) levels is observed at the time of disease progression and retrospective     data suggest that benefit from the continuation of bevacizumab may be restricted to patients     with high levels of soluble VEGFR-2 at the first evidence of disease progression. This study     aims at prospectively validating those retrospective data.   "
50611|NCT02623127|"     This study aims to investigate the clinical activity of sunitinib in patients with advanced     thymic carcinoma who have failed chemotherapy.   "
50612|NCT02623114|"     The purpose of this study was to identify genetic, brain morphologic, and environmental     biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity disorder     (ADHD).   "
50574|NCT02623608|"     After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary     increase, triggering a wave of oxidative stress due to the appearance of excess free radicals     in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated     with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial     changes in different circulating biomarkers are potential predictors of cardiometabolic risk.     In addition to the possibility of evaluating acute variations in metabolic risk markers in     response to different types of fat, the metabolic challenge approach may serve as a     challenge-meal background in order to reveal possible beneficial effects of specific food     ingredients. In this study, circulating cardiometabolic disease-related biomarkers, including     endotoxemia, will be assessed postprandially in search for beneficial actions of particular     functional food ingredients consumed in combination with a high-fat meal.   "
50575|NCT02623595|"     The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)     combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is     safe, effective in the treatment of stage IV NSCLC patients who failed in second-line     chemotherapy.   "
50576|NCT02623582|"     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously     administered, RNA electroporated autologous T cells expressing anti-CD123 chimeric antigen     receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as     RNA CART123) in Acute Myeloid Leukemia (AML) subjects.   "
50577|NCT02623569|"     Arms Assigned Interventions      Experimental: Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day     when positive ETT and HR＞60times/min or negative ETT and HR＞80times/min of subjects.      Active Comparator: Atenolol Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a     day when positive ETT and heard rate＞60times/min or negative ETT and HR ＞80times/min of     subjects.   "
50578|NCT02623556|"     720 cases TB (Tuberculosis patients) participants and 360 cases non-TB participants with lung     disease who all meet the standard are divided into different groups through a randomized and     blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified     protein derivative) in different arms of the same person by blind method. Specific     gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and     (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier     caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse     events.   "
50579|NCT02623543|"     The high prevalence of myopia - especially in Asian countries - is well documented, as are     the sight-threatening complications of high or degenerative myopia. Retinal detachment,     glaucoma, vitreal degeneration and focal retinal changes occur secondary to the progressive     axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen     this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at     night and change the corneal topography to correct low to moderate amounts of myopia. This     same axial elongation has also been shown to occur in young adults with high near demands,     however to our knowledge, there are no studies examining the effect of ortho-k lenses in this     population. Our project seeks to investigate the efficacy of ortho-k in slowing axial     elongation and myopic progression in subjects between the ages of 21-30. Results will help     elucidate what role these specialty lenses may have in the management of the myopic patient     throughout their development, as well as what potential they have in prevention of associated     degenerative changes.   "
50580|NCT02623530|"     Considering the need for an intervention in the context of the Brazilian nursing education,     in order to develop the skills and dispositions for critical thinking (CT), this study aims     to fill this gap through a first aid course, comparing a group control and an experimental     group. In this study will be used two tests, California Critical Thinking Dispositions     Inventory (CCTID) to review arrangements for the CT, and California Critical Thinking Skills     Test (CCTST) to evaluate CT skills, both marketed (Facione N, Facione PA, 2009 , 2011).     Therefore, in order to facilitate the assimilation of PC skills during the course, we     prepared the model of Active Teaching for Critical Thinking (MEAPC): characterized by a     teaching method proposed by the author of this work, who understands the educational activity     active and intentional as mobilizing higher mental processes fundamental to the development     of the CT.   "
50581|NCT02623517|"     Patients with implantable heart devices including pacemakers, defibrillators, and cardiac     monitors may not seek regular medical care related to their implanted devices. These devices     are capable of detecting abnormal heart rhythms or other device abnormalities that may     benefit from clinical action or oversight. A novel healthcare information technology has been     developed and is being implemented clinically for screening of patients with cardiac rhythm     devices who seek care in the emergency room setting. This study seeks to examine differences     in detection of cardiac rhythm disturbances including atrial fibrillation (AF) with     utilization of this new screening technology, and how often treatment plans change in     patients who have a heart rhythm abnormality detected.   "
50606|NCT02623192|"     This registry was proposed to investigate the epidemiology of respiratory mechanics in     patients with ARDS through collecting data from a QI project which was constituted with     systematic assessments of respiratory mechanics and gas exchange.   "
50585|NCT02623465|"     The study will be conducted in participants with type 2 diabetes on insulin injection therapy     to investigate how the body processes a test formulation of insulin lispro and the effect of     the test formulation on blood sugar levels. Side effects and tolerability will be documented.     The study will be conducted in two parts (Part A and Part B) to achieve its objectives.     Participants are expected to enroll in both parts.   "
50586|NCT02623452|"     The study will be conducted in participants with type1 diabetes on insulin injection therapy     to investigate how the body processes a test formulation of insulin lispro and the effect of     the test formulation on blood sugar levels. Side effects and tolerability will be documented.     The study will be conducted in two parts (Part A and Part B) to achieve its objectives.     Participants are expected to enroll in both parts.   "
50587|NCT02623439|"     The primary objective is to determine overall survival 180 days after transplantation     involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.   "
50588|NCT02623426|"     The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will     compare the relative efficacy and safety of intravitreal methotrexate, intravitreal     ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular     edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a     parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6     month clinic visit. The primary outcome is percent change in central subfield thickness from     the baseline OCT measurement to the 12 week visit.   "
50589|NCT02623413|"     The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of     colonization and infection aand hospital-acquired VRE transmissions.      Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and     adhering to at least the following standard of care are eligible for study participation:      Fecal screening for the presence of VRE of all patients within 72 hours of each admission by     use of a rectal swab or stool sample Follow-up fecal screening once a week and within 72     hours of discharge Implementation of clinical standards aimed at VRE decolonization is not     allowed on wards participating in this study, including in the context of clinical studies.      Sites will be grouped according to their approach regarding contact isolation (see group     description).      As a control for external factors a hand hygiene program, including training and adherence     assessments, will be implemented.      This observational study prospectively compares wards with different approaches to isolation.     All screening and isolation measures are already in place on participating wards (i.e.     constituted a site selection criterion) and are exclusively implemented as part of the     standard of care. Sites are free to adjust their standard of care as they see fit. No     intervention will be performed.   "
50590|NCT02623400|"     In this project, the investigators will study a cohort of preterm infants, together with     their parents, during NICU hospitalization and follow their developmental trajectory until     the age of two.      An important first scientific goal of the project is to identify objective stress markers     that can be obtained easily and non-invasively in preterm infants during NICU     hospitalization. This will include the development of novel techniques to measure stress     related heart rate variability (HRV) and EEG maturation, as well as sleep stage markers for     preterm infants.      Secondly, the investigators will study the emotional and bonding processes in parents of     preterm infants. Parental distress in terms of depressive symptoms, anxiety, perceived stress     and parent-infant bonding will be measured at multiple measuring points. This will enable the     validation of psychometric instruments in the specific population of parents of preterm     infants. Also, the investigators can investigate the effect and predictive value of the     course of parental depression, anxiety and stress scores on child's developmental outcome and     on parent-infant bonding and attachment.      Thirdly, studies on epigenetic changes due to prenatal stress are still scarce in humans. In     this study, the investigators will include a cohort of mothers experiencing profound prenatal     stress due to preterm labor, which will complement the earlier work that has been carried out     in a low-risk population. The investigators expect more profound changes in methylation state     of the NR3C1 and other promotor regions in their cohort of mothers exposed to important     prenatal stress. Secondly, the methylation of oxytocin receptor regions will be studied in     relation to attachment and bonding.      An important overall goal of the project is to develop a Perinatal Stress Calculator that     studies the value of the different neonatal, endocrinological, psychological and     physiological stress-related parameters to predict differences in psychomotor, cognitive,     behavioral, and emotional development. This longitudinal study design will enable the     investigators to use the perinatal stress calculator to study the relation between the     perinatal stress parameters and later developmental disabilities such as motor impairment,     cognitive deficits, language delay but also social and behavioral problems such as     attentional deficits and emotional self-regulation dysfunction.   "
50591|NCT02623387|"     The aim of this study is to compare conventional and ultrasound guided paravertebral blocks     to with respect to efficacy, patient satisfaction and complication rates.   "
50592|NCT02623374|"     The study will be a randomised controlled trial (RCT) of a brief self-help CBT intervention     (SHCBT), compared with a no treatment-wait control (NTWC) who do not receive the     intervention, on the impact of hot flushes experienced by menopausal women in work settings.     The study involves samples from a minimum of two large employers (who have already expressed     an interest in taking part) and randomly allocating at least 50 eligible women to the SHCBT     intervention and another 50 to a NTWC condition (i.e. a minimum of 100 participants in     total). Both groups will complete baseline questionnaires (A0), and follow up assessments at     6 weeks (A1) and 20 weeks (A2) post-randomisation. Questionnaires will be completed online or     paper and pencil, providing data on the outcomes of interest to assess the interventions     effectiveness and feasibility. Participants of the treatment group will also be invited to     take part in an evaluation interview at A2. The NTWC will be offered the intervention     off-trial.   "
50593|NCT02623361|"     Patients undergoing arthroscopic hip surgery have been shown to have significant     post-operative pain that may delay discharge, recovery, and early mobilisation. A     pre-operative regional anesthesia technique, the fascia iliaca block may be an effective     method for acute post-operative analgesia.      This is a prospective, randomized controlled study of the preoperative fascia iliaca block     for patients undergoing hip arthroscopy.      The enrolled patients will be randomized to receive either a fascia iliaca block with the     local anesthetic ropivacaine or to have a sham block. All patients will receive a general     anesthetic for the hip arthroscopy.   "
50594|NCT02623348|"     Randomized controlled trial using pedometers to increase physical activity among patients on     dialysis.   "
50607|NCT02623179|"     In this protocol, the investigators are examining the use of a novel pathogen testing     technology and method of identification of antibiotic susceptibility against the conventional     C & S testing for patients with both complicated and uncomplicated UTIs. The investigators     will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic     accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3)     quality of life as defined by particularly symptomology and bothersomeness of the symptoms;     and 4) overall cost.   "
78626|NCT02256709|"     Safety, tolerability and pharmacokinetics (including comparisons of different formulations     and investigation of food effect)   "
50595|NCT02623335|"     The investigators will perform a multi-site cluster randomized trial that uses a     stepped-wedged design to compare the effectiveness of a Question Prompt List (QPL)     intervention to usual care for patients considering high-risk vascular (peripheral, cardiac,     neuro) and oncologic operations. This 24-month study will use a time-dependent cluster     randomization plan within each of the five study sites: the investigators will randomly     assign time points for surgeons who perform high risk operations to cross over from usual     care to QPL intervention. Study staff will audiotape the conversation between the patient and     surgeon during one preoperative clinic visit; administer surveys to patients and family     members at 24 hours, 6 weeks and 12 weeks after that visit; and record surgical decisions,     treatments received and associated outcomes. The investigators will use stratified purposeful     sampling to identify a subset of patients in each study arm who have experienced serious     complications for qualitative interviews.   "
50598|NCT02623296|"     This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over,     drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or     placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail     of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450 substrates     will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19 substrate) and     100 mg caffeine (CYP1A2 substrate).      Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day 12     a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450     substrates will be co-administered either with GLPG1205 or with placebo. The two treatment     periods will be separated by a wash-out period of at least 28 days.      Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or     without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.   "
50599|NCT02623283|"     Historically dental health of Scottish children had been poor for many years. Evidence form     clinical trials of fluoride toothpaste identified a route to improving prevention. Those who     had poor dental health used fluoride toothpaste infrequently at home. The investigators     hypothesised that this disadvantage could be overcome by supplying toothpaste to     disadvantaged families and supervising child toothbrushing at school. In 1997, 534 children     5.3 years were recruited in 12 primary schools in Tayside; randomly assigned to one of two     groups - test group followed a home-to-school toothbrushing programme with fluoride     toothpaste; control group: usual care. Children in test group were provided with toothbrushes     and toothpaste (1,000ppmF as sodium monofluorophosphate) for home use; also brushed their     teeth school daily. After 2 years, children participating in the supervised brushing     programme developed significantly less caries (tooth decay).      Permission was given for longitudinal follow up of children and dental records. The original     intervention lasted 30 months and children were re-examined at 36 months after baseline, 48,     60 and 84 months. At 84 month examination, 77% were available, found prolonged benefits of     brushing programme. This was 4.5 years after the end of the programme; children were aged     11.5 years. At age 14 years, 6.5 years after intervention end, 65% of children were     reexamined; benefit was still evident at 20-26% less caries experience. However, there had     been greater subject loss and insufficient funds available to undertake a more individual     followup of participants.      Since then, records have been followed; up-to-date contact details identified. Using this new     data, the investigators seek to reconsent the participants, now aged 23 to invite them to     attend a followup dental examination. This study has the potential to provide unique     information on longterm costs and benefits of a home-to-school toothbrushing programme.   "
50600|NCT02623270|"     The purpose of this study is to determine whether an experienced anesthesia provider can     adequately and/or easily mask ventilate an anesthetized patient with a commercial     non-invasive ventilator device.   "
50601|NCT02623257|"     The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in     advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.   "
50602|NCT02623244|"     To assess the relationship between ovarian endometrioma and lower urinary tract symptoms,     sexual function and gastrointestinal symptoms. In addition, the investigators also assess the     impact of surgeries for ovarian endometrioma on lower urinary tract symptoms, sexual function     and gastrointestinal symptoms.   "
50603|NCT02623231|"     Testing the effect of providing an antidepressant and anxiety-type escitalopram for patients     with glioblastoma on patient's quality of life including the effect of treatment on mood and     cognition during treatment.Two subgroups will fill questionnaires :        -  Questionnaire mini mental state exam (mmse) which is the maximum score of 30. A score of          below 24 indicates a flaw in the level of dementia        -  Questionnaire depression / mood PHQ9P(Pa t i e n t H e a l t h Qu e s t i o n n a i r e          - 9)        -  The M. D. Anderson Symptom Inventory (MDASI)        -  Evaluation of the hospital situation awareness (clinical assessment and questionnaire)        -  Cognitive assessment which will be carried out by the Department neuropsychological and          include:             -  Executive function (Stroop)             -  Abstract Reasoning (similarities)             -  -Auditory and Spatial Attention (Digit span, Spatial span) visual memory and               remembering Literature             -  Memory function - visual and auditory (ROCF, RAVLT)             -  Language function: Naming and verbal fluency             -  Mindstreems Neurotrax   "
50604|NCT02623218|"     The purpose of this study is to examine the effects of acupuncture on cerebral blood flow     (CBF) and blood biomarkers during the acute 10-day window following traumatic brain injury,     to determine if those changes correlate with changes in biomarkers of brain health,     neuropsychological testing, and symptomatic presentation.   "
50605|NCT02623205|"     Despite current medications, morbidity and mortality of Major Depressive Disorder (MDD)     remain high. According to the World Health Organization, MDD affects 121 million people     worldwide, and is projected to be the second leading cause of global disability by 2020.     Monotherapy with SSRIs is the most widely used treatment for MDD. However, on average, SSRIs     require six weeks for onset of action, and two-thirds of those on SSRIs fail to achieve     remission.Compounding this problem, patients with residual symptoms are significantly more     likely to discontinue treatment or relapse, be hospitalized for medical and psychiatric     conditions, or die of suicide and other causes. Although eliminating ineffective treatment     trials would significantly reduce patient suffering and healthcare costs,clinicians currently     do not have the tools to objectively select treatment based on an individual's likelihood of     remission. Therefore, there is an urgent need to identify markers predictive of an     individual's SSRI treatment outcome. Developing this personalized treatment requires     increased understanding of the relationship between pretreatment neurobiology, SSRI-induced     biological changes, and the corresponding symptom improvements.   "
50608|NCT02623166|"     The investigators propose to test the feasibility and acceptability of community health     workers (ASHAs and ANMs) being able to treat sick children in the community. There is a     national policy for treatment for children aged 2-59 months with illnesses such as pneumonia,     diarrhea and fever by community health workers (CHWs), this policy has not been implemented     as yet in Haryana. This research will identify barriers and opportunities for use of CHWs as     treatment sources.   "
50609|NCT02623153|"     The choice of neoadjuvant chemotherapy regimen for locally advanced gastric cancer is     controversial. The aim of this study was to compare the short- and long-term outcomes of     XELOX regimen with Docetaxel, S1 and oxaliplatin regimen as neoadjuvant chemotherapy regimen     for locally advanced gastric cancer. The objective of this study is to determine what kind of     neoadjuvant chemotherapy strategy can make subsequent radical surgery feasible and improve     overall survival in patients with locally advanced gastric cancer.   "
50610|NCT02623140|"     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is     to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with     a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using     registry detection of clinically driven events   "
50613|NCT02623101|"     Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising     number of skin cancer may result in long waiting lists for consultation at departments for     dermatological care and in increasing health care costs. In case of suspicion on skin cancer     it is of utmost importance to diagnose and treat in an early phase, preferable in a patient     friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal     cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK)     and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of     51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type.     In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold     standard for diagnosing a BCC. With the implementation of non invasive diagnosis by     reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be     assessed at the first consultation in a non-invasive way and the patient can be treated     instantly.      Overall, the aim of this study is to investigate whether reflectance confocal microscopy can     correctly identify the subtype of basal cell carcinoma.      Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and     excision.   "
50614|NCT02623088|"     Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a     independent cardio-vascular risk factor.      Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study     measurements of arterial stiffness, and are strong predictors of late cardiovascular events.      This study will compare long term evolution in arterial stiffness (PWV) and endothelial     dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.   "
50615|NCT02623075|"     Influenza infection in solid organ transplant recipients is associated with increased     morbidity and mortality compared to non-transplanted controls, due in part to the effects of     immunosuppression which is necessary to prevent rejection of the transplanted organ. However,     transplant patients are less likely to produce antibodies when vaccinated and when they do,     the peak and duration of antibody responses are reduced compared to healthy controls. There     are considerable differences in the magnitude of these responses, reflecting variability in     individual responses to the influenza vaccine and to the immunosuppression regimen. The     investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression     will have post vaccine immune responses that are comparable to age and gender matched healthy     controls.   "
50616|NCT02623062|"     This study is being conducted in China to provide evidence for inclusion in applications to     competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective     in managing the symptoms of heartburn and acid regurgitation in patients with     gastro-esophageal reflux disease (GERD).   "
50617|NCT02623049|"     Background: The incidence of atrial fibrillation(AF) increases substantially with age and it     is estimated that more than one third of AF patients are octogenarians. Direct oral     anticoagulants (DOACs) were found favorable compared to warfarin with respect to efficacy and     safety ( bleeding) across wide range of ages.      Nevertheless, the rates of bleeding among elderly patients were shown to increase     substantially with all anticoagulants. Dose-adjustments of DOAC are not universally performed     among patients older than 80 years old and currently there is paucity of data regarding the     actual drugs level among these patients. Accordingly, the investigators sought to investigate     the drug levels of the different DOACs among real world octogenarians who receiving     guideline-recommended dosage.      Methods: A cross sectional, prospective study of 120 hospitalized and ambulatory patients who     are treated with DOACs for AF.      DOACs blood levels with be compared between octogenarians (n=70) and younger patient group (     age≤70 year-old; n=50).The cohort will include: 1)Sixty patients on APIXABAN: 40     octogenarians and 20 younger than 70 years, 2)Forty patients on RIVAROXABAN: 20 octogenarians     and 20 younger than 70 years, and 3) Twenty patients treated with DABIGATRAN: 10     octogenarians and 10 younger than 70 years.      DOACs Pharmacodynamic analysis will be performed using commercial kits for diluted thrombin     time(DTT) and anti-factor Xa activity (AFXa). Drug level will be measured at steady state(     through levels) and at Tmax after at least 4 days of complete adherence for DOAC consumption.      Study End-Points:The study main objectives are: 1) DOACs levels in octogenarians in     comparison to patients younger than 70 years and 2)percentage of patients, in each group, who     have target DTT or AFXa ( predicted) at steady state.      Potential significance of the study:      The results of the study may provide new data on DOACs levels in octogenarians and thus would     either support current recommendations or set the ground for further studies aim to optimize     DOACs dosage in this vulnerable population.   "
50618|NCT02623036|"     The purpose of this study is to use ambulatory blood pressure monitors to investigate whether     enalapril is superior to lisinopril in managing nocturnal hypertension in patients with     resistant hypertension currently treated with daytime angiotensin converting enzyme     inhibitors.   "
50685|NCT02622152|"     Directly following cardiac surgery for congenital heart disease; patients are not receiving     routine turning every two hours to prevent pressure ulcers, because a negative influence on     hemodynamic parameters is assumed. Investigators have suggested that lateral position may     have clinically significant effects on oxygenation in cardiac surgery patients.   "
50686|NCT02622139|"     Monocentric, prospective interventional study to assess the degree of disease activity with a     multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's     disease or ulcerative colitis.   "
50619|NCT02623023|"     The purpose of our study is to determine the effect of prophylactic treatment with     brimonidine/timolol fixed combination (Combigan®, Allergan; Dublin, IRL) or placebo therapy     (Refresh tears®, Allergan; Dublin, IRL) on long-term IOP measurements in patients receiving     serial intravitreal injection of 0.5 mg ranibizumab (0.05 mL) with six months follow-up.     Intraocular pressure measurements will be correlated with changes on ancillary testing     (Humphrey 24-2 visual field testing and optical coherence tomography (OCT) of the optic nerve     head (ONH). Our study would be the first large, prospective, randomized double-blind     placebo-controlled trial to examine the relationship between anti-vascular endothelial growth     factor (VEGF) therapy and sustained ocular hypertension.   "
50620|NCT02623010|"     The study will include 30 elderly patients age 60-85 with primary CNS DLBCL . Induction     treatment will include Rituximab and high dose methotrexate protocol (containing at least     methotrexate and one more chemotherapy agent).      Patients with MRI documented response CR or PR will enter the study protocol maintenance     phase which will include continous treatment with Ibrutinib 560 mg day until relapse or     disease progression or occurrence of limiting toxicities   "
50690|NCT02622087|"     The purpose of this study is to determine whether levels of sex hormones (including estrogen     and progesterone) influence women's response to treatment for Specific Phobia of spiders. It     is hypothesised that women will show less relapse of symptoms of spider phobia if they     receive treatment during a period of high levels of sex hormones.   "
50621|NCT02622997|"     60 women from the Colposcopy Clinic at the Royal London Hospital will be recruited, having     been referred following an abnormal cervical screening result.      Aim Human Papillomavirus (HPV) is very common and can cause cervical cancer in some women.     There is interest in HPV testing in place of the smear test currently used for cervical     screening. HPV testing has potential for women to take self-samples.      These self-samples have up to now mostly been placed into liquid to preserve them before     testing. Using liquid however, makes it more difficult to collect samples at home due to     spillage and the logistics of posting. Investigators plan to investigate whether dry samples     are reliable. Investigators would also like to know if samples can still be used if not     tested immediately, particularly in warm temperatures. This would prove useful in the     countries that have found it difficult to set up national cervical screening programmes.      Trial Design Investigators are asking women to take three vaginal self-samples before     patients' colposcopy examination. The samples will be two swabs and a third using the HerSwab     device, designed to make taking a sample easier. Investigators will give women instruction     sheets with illustrations. Samples, taken in a random order so that all samples have an equal     chance, will be sent to the laboratory for testing but under different conditions. Samples     will be either frozen immediately, stored at 25ºC for one week or two weeks and then frozen.     All samples will then undergo HPV testing. Investigators wish to see if all conditions and     swabs provide similar amounts of HPV.      Enrolment is planned to start in May 2015. Sample processing and testing will continue until     enrolment is complete and for a further month. Smear and biopsy results will be collected for     up to 6 months to see if they affect quantities of HPV.   "
50622|NCT02622984|"     The traditional paradigm that relies upon training physicians and nurses or uses on-site     interventionists to perform screening, brief intervention, and referral to treatment (SBIRT)     for alcohol has proven unsustainable in most clinical settings. The Remote Brief Intervention     and Referral to Treatment (R-BIRT) for alcohol is an innovative telehealth service model with     potential to improve public health through evidence based counseling for patients who exceed     the NIAAA low risk drinking limits or have evidence of an Alcohol Use Disorder with     professional and self-help treatment. For those that are appropriate, the R-BIRT service will     provide facilitated referrals to specialized alcohol abuse treatment. The service model is     being studied in the emergency department (ED) setting to demonstrate its utility in a     medical setting with a very high prevalence of risky alcohol use and Alcohol Use Disorders;     however, the model is relevant and will be accessible to a broad array of healthcare     settings, including primary care practices. Our new model, the R-BIRT, challenges the     prevailing paradigm and offers the promise of not only clinical efficacy but increased cost     effectiveness as well.   "
50623|NCT02622971|"     Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to     measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any     procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric     test in isokinetic dynamometer to measure muscle function). After, volunteers performed the     exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after     exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS     measure and MVC test were repeated. The treatments according to randomisation were performed     three minutes after exercise protocol and it were performed again in 24, 48, 72h after     eccentric exercise.      The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle     damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute, 1     hour, 24, 48, 72 and 96 hours after exercise protocol).   "
50624|NCT02622958|"     The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute     Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The     hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to improve     performance and interaction anxiety in patients with diagnosed Social Anxiety Disorder (SAD).   "
50625|NCT02622945|"     This study aims to determine whether transcranial direct current stimulation (tDCS) paired     with speech-language therapy is more beneficial than speech-language therapy alone in acute     and chronic post-stroke aphasia.   "
50626|NCT02622932|"     The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C]     Anlotinib in Patients With Advanced Cancer patients.   "
50627|NCT02622906|"     The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some     cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies     suggest that treatment with somatostatin analogue would reduce transfusion requirements in     patients with recurrent bleeding due to angiodysplasia.      No randomized studies are available. The main objective of this study multicenter,     prospective, randomized, was to assess the transfusion requirements in patients with     recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin,     Pasireotide, versus placebo.      Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic     treatment failure, with a need transfusion at least 6 red blood cells during the 6 months     prior to inclusion could be randomized to receive monthly intramuscular injection of     Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an     additional 6 months after stopping treatment. A test monthly clinical and laboratory was     performed during the six months of treatment then quarterly during the six months of     surveillance.   "
50769|NCT02621060|"     Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control,     obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show     that Chlorogenic acid has an excellent potential for the control of glucose as well as     insulin secretion and insulin sensitivity.   "
57205|NCT02536781|"     The purpose of this study is to compare the oral inflammatory reduction effect caused from     orthodontic treatment of anthocyanin and placebo mouthrinse.   "
50650|NCT02622607|"     Bone metastases are common in patients with advanced lung cancer and can have devastating     consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates     are inhibitors of osteoclast-mediated bone resorption. The current indications for     bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g.,     osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and     the prevention of skeletal-related events(SREs）from malignant bone disease. Clinical trials     also confirm that bisphosphonates, and zoledronic acid（ZOL) in particular, can prevent bone     loss from cancer treatment.There is also emerging evidence that the benefits of     bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate     whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage     IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free     survival (PFS) and overall survival(OS), and delay time to bone metastases .   "
50628|NCT02622893|"     Background: We performed this prospective clinical study to compare the post-operative     recovery profile of our patients after transperitoneal and retroperitoneal laparoscopic     nephrectomy techniques. Our primary aim was to compare post-operative epidural analgesic     consumption of transperitoneal (Group T) and retroperitoneal (Group R) laparoscopic     nephrectomy patients within the first 24 hours.      Methods: Forty-four patients scheduled for elective transperitoneal or retroperitoneal     laparoscopic nephrectomies were enrolled. All patients in both groups received epidural     catheter, 2.5ml test dose of lidocaine 2% and general anesthesia induction. At the end of the     surgery, patients were given 1g IV paracetamol and 10ml 0.25% bupivacaine through epidural     catheters and extubated. In the post-operative care unit, patients started to receive a     continuous infusion of 0,1% bupivacaine and 1µg/ml fentanyl 5ml/h with patient-controlled     boluses of an additional 4ml by a patient controlled epidural analgesia (PCEA) device. They     were prescribed IV tramadol 1mg/kg as a rescue analgesic (Visual analog scale (VAS)≥4). Total     analgesic consumptions from PCEA devices, VAS scores at rest and during mobilization, heart     rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs) at extubation (0th min-basal)     and at post-operative 30th min, 2nd, 6th, 12th, 18th and 24th hours as well as number of     patients who require rescue analgesic were recorded. Nausea, vomiting, time to first     mobilization, return of bowel sounds and hospital stay were also documented.   "
50629|NCT02622880|"     The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days     before surgery , on the number and characteristics of postoperative infections for a period     of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell     cancer patients, candidates for surgery.   "
50630|NCT02622867|"     The purpose of this study is to evaluate the effects of the probiotic Lactobacillus plantarum     3547 over different inflammation and immune system markers on a healthy middle-aged group.   "
50631|NCT02622854|"     To compare effectiveness in reducing triglycerides between daily plasma exchange and     glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis     with mildly elevated triglycerides   "
50632|NCT02622841|"     The aim of this study is to assess the feasibility and safety of combining stereotactic body     radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of     painful unstable metastases of the thoracic and/or lumbar spine.   "
50633|NCT02622828|"     The purpose of this study is to examine whether intervention strategies targeted at the level     of the environment (e.g. improving access to community based leisure groups, transportation)     can successfully promote the community participation experiences of community-dwelling older     adult Manitobans who use wheelchairs in the winter.   "
50634|NCT02622815|"     There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has     the capacity to activate the hemostatic system and this leads to an increased thrombotic risk     in cancer patients. Even in the absence of clinical manifestations, cancer patients are     commonly characterized by hemostatic abnormalities, recognized only by laboratory testing,     which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly     reported to be associated with tumor progression and poor prognosis in various carcinomas. On     the other hand, thrombotic event can represent the first signal of the presence of an occult     tumor. These findings suggest that the coagulant pathway might play a role in the preclinical     phase of cancer. The investigators hypothesize that a persistent, subclinical activation of     the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis,     but also to tumor formation and spreading. A major problem in primary cancer prevention is     the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing     prospective Italian multicenter study organized around two tightly-interconnected research     programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk     prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors     of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region;     and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis     (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes     (i.e. overall survival, progression free survival in metastatic cancer, disease free survival     in limited disease) in cancer patients with different types of solid tumors (i.e. breast,     lung and gastrointestinal cancers).      Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful     for anticipation of cancer diagnosis. In addition, the results of this study might help to     evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the     disease extension.   "
50635|NCT02622802|"     The most important guideline for drug prescription concerning pregnant women is 'drugs should     be given only if the maternal benefits outweigh the potential risk to the fetus'. However,     poor data is available on maternal drug disposition and transfer through the placenta, so the     evidence available for decision making in clinical practice is weak.      An ex-vivo placenta perfusion model will be used to explore the mechanisms governing     differences between fetal and maternal drug exposure. The expression of placental     transporters and cytochrome P450 (CYP) enzymes will be investigated in primary placenta cell     culture and placental biopsies from different gestational stages to learn how the placental     drug transfer and disposition is regulated.      The investigators choose to examine the transfer of paracetamol, erythromycin and     azithromycin because these drugs are commonly used in human pregnancies and have different     metabolic pathways.   "
50636|NCT02622789|"     An assessment of the effectiveness of Pilates based physical therapy exercises for patients     with low back pain (LBP) and its influence on spinal movement and patient reported functional     disability.   "
50637|NCT02622776|"     This pilot study is the first step in the development of an new assay that may be further     tested as a screening method for ovarian and endometrial cancers.   "
50638|NCT02622763|"     Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.   "
50639|NCT02622750|"     The purpose of this study is to compare triple-branched stent placement with total-arch     replacement in the treatment of acute DeBakey I aortic dissection . The investigators design     optimal effect compera prospective, multi-center, randomized, open-label, parallel-group,     non-inferiority clinical trial.   "
50661|NCT02622464|"     Post-operative scarring on vocal cords is responsible for disorders of the vibration of the     lining to the original dysphonia can be troublesome for the patient both in his private and     professional life. There is no currently codified treatment for this type of situation and no     therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a     liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal     vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population     including multipotent stem cells similar to mesenchymal stem cells present in bone marrow.     The investigators hypothesis is that the trophic and antifibrotic properties of SVF could     benefit patients with vocal cords scarring responsible for dysphonia.   "
79467|NCT02245724|"     The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy     in mental retardation.   "
50640|NCT02622737|"     Introduction: Population aging is associated with increased prevalence of chronic diseases.     Parkinson's disease (PD) is the second most common neurodegenerative disease in the world     population, affecting motor function and functional independence progressively. The     physiological aging promotes the gradual reduction of body weight, lung function, peripheral     muscle strength, cardiopulmonary endurance and physical capacity, which increase the     debilitating effects. Aging, when associated with PD, can induce loss of functionality,     postural changes, further affecting the nutritional status, worsening the quality of life and     functional independence of the individual. Although physical therapy is commonly applied with     a variety of methodologies to PD patients, evidence for the effectiveness of these     interventions is lacking.      Objective: The primary objective of the study is to compare the effects of Functional     Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly     participants with PD. In addition, the secondary objectives are to compare the effects on     cardiopulmonary endurance, posture, postural control, executive function, quality of life and     functionality of individuals with PD.      Methodology: This is an interventional, randomized, blinded, longitudinal and prospective     study. This research will be conducted in the State Reference Center for Health Care of the     Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The     Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with     undergo training with Stationary Bike and the Experimental Group 3 will be submitted to     exergame training using Xbox360 with KinectTM sensor. All the interventions will be performed     three times per week, with 50 minutes per session, during 8 weeks.   "
50641|NCT02622724|"     In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human     interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have     acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which     a patient need to be on the ventilator and improve patient's chances of survival. Currently     there are no approved drugs for treating moderate or severe ARDS patients.   "
50642|NCT02622711|"     The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused     on weight loss in a group of overweight or obese women previously treated for early breast     cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase     physical activity and decrease sedentary time, taking advantage of a pedometer-like device.   "
50643|NCT02622698|"     Investigators performed a randomized controlled trial of 62 patients undergoing elective     abdominal operations. The treatment group was provided a liquid protein supplement and     instructed to take a dose three times daily for the first 20 postoperative days.     Investigators followed patients for six months and compared wound healing and changes in     weight and laboratory values.   "
50644|NCT02622685|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and     pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.   "
50645|NCT02622672|"     Diabetes is considered an oxidative stress and a chronic inflammatory disease. Coenzyme Q10     (ubiquinone) is recognized as a lipid soluble antioxidant. Ubiquinol is a reduced form of     coenzyme Q10 in our body after food or supplements intakes. Studies have indicated that the     water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble.     The purpose of this study was to investigate the effects of a water-soluble ubiquinol     supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.   "
50646|NCT02622659|"     Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre     clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with     influenza (acute upper respiratory infection).   "
50647|NCT02622646|"     Haemophilia A is an inherited bleeding disorder caused by a deficiency of factor VIII     (FVIII). Patients with severe hemophilia A have a FVIII plasma concentration less than1 IU/dL     and experience spontaneous and trauma-induced bleeds. Joint bleeds lead to hemophilic     arthropathy resulting in progressive disability. Patients with moderate hemophilia (FVIII     level between 1-5 IU/dL) are characterized by fewer hemarthroses, usually trauma-induced, and     a decreased likelihood of developing arthropathy. This clinical observation led to the use of     prophylactic FVIII infusions to convert patient´s bleeding phenotype from severe to moderate     with the result of decreasing or preventing arthropathy.      Prophylactic regimens may be effective when based on standard fixed-dose protocols (that     assumes one approach fits all patients) or phenotypic dosing determined by bleeding patterns,     but do not protect all patients with severe haemophilia from joint damage caused by     spontaneous or activity-triggered bleeding.      Individualized treatment in haemophilia A takes into consideration all available information     about the patient, not only his phenotypic bleeding pattern. Some of the factors that     contribute to the observed interpatient variability include baseline or residual FVIII     activity, the pharmacokinetic (PK) profile of the replacement factor, the individual's level     of physical activity and perceived risk of traumatic bleeding, the presence or absence of     joint disease, presence of comorbidities and adherence to the dosing regimen.      Objectives:      Identify and analyze cause(s) of poor bleeding control in patients on prophylaxis treatment     and study the clinical impact of a personalized pilot program with a 1 year follow up to     act on the specific causes.        1. Describe PK parameters in patients on prophylaxis treatment with Advate®.        2. Analyze differences in PK parameters in non-controlled vs well controlled patients.        3. Identify causes of poor clinical outcome in non-controlled patients. Patients'          individual variables that influence bleeding risk will be studied (individual PK,          bleeding pattern, joint status, physical activity, life style and patient's adherence).        4. Study the improvement in clinical outcomes (ABR and Joint status) of a 1 year          Personalized Prophylaxis Program that acts specifically on the previously identified          causes of bleeding in non-controlled patients (named: short half-life, high bleeding          pattern, joint damage, high risk physical activity, active life style and poor patient's          adherence).   "
50648|NCT02622633|"     This study aims to analyze the effectiveness and feasibility of using an implantable system     that provides epidural electrical stimulation directly to the left prefrontal dorsolateral     cortex (Brodmann area 9/46) in patients with chronic and refractory Depressive Disorder     Major.   "
50649|NCT02622620|"     Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and     monitoring for tumor recurrence,but the ability to predict tumor behavior remains very     limited.In this study, the investigators will use multi-b-value diffusion-weighted     imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced     MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.   "
50662|NCT02622451|"     This pilot study conducts feasibility and exploratory intervention outcome research that will     lead to the development of a personalized intervention framework that seeks to preempt the     progression from early drug use to more chronic abuse and dependency. The study will explore     moderators representing two frameworks, risk severity and differential sensitivity.     Moderators will be explored in their ability to influence the differential efficacy of two     adolescent drug abuse interventions.   "
51378|NCT02613104|"     Previous research suggests that people with bipolar disorder have trouble accurately     identifying emotions. The goal of this study is to test a novel intervention, emotion     recognition modification (ERM), to help improve the ability of young people with bipolar     disorder to identify emotions.   "
50651|NCT02622594|"     This is an investigator initiated, two center, randomized, evaluator-blinded, bilateral     (right vs. left) study of photodynamic therapy in subjects with facial actinic keratoses.      Subject's face will be randomized to receive one of four treatments: Treatment 1, Treatment     2, Treatment 3 or Treatment 4. Treatment 1 will include microneedling performed prior to ALA     application to their right face and ALA application only to the left face 60 minutes prior to     BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 2 will include     microneedling performed prior to ALA application to their left face and ALA application only     to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16     minutes 40 seconds). Treatment 3 will include microneedling performed prior to ALA     application to their right face and ALA application only to the left side of their face 30     minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 4     will include microneedling performed prior to ALA application to their left face and ALA     application only to the right side of their face 30 minutes prior to BLUE light treatment for     1000 seconds (16 minutes 40 seconds). The face is defined as the surface of the skin     encompassing the forehead to the hair line and tops of the eyebrows, the entire nasal dorsum,     the cheeks (bounded by the orbital rim, the anterior border of the ear, the jawline, the nose     and the chin), the upper lip (not including the vermilion border) and the chin (bounded by     the lower edge of the vermilion border, the cheek junction and the jawline). The treatment     areas will be not be occluded. A line will be drawn with a marker that intersects the nose,     forehead, upper lip and chin in the midline. The left face is defined as the face to the left     of this line and the right face is defined as the face to the right of this line.     Posttreatment follow-up visits will be scheduled to occur 48 hours after the treatment and at     1, 3 and 6 months after the treatment. A blinded evaluator who will remain blinded with     respect to the randomization will conduct grading of the subject's actinic keratoses and     photodamage. Tolerability of treatment will be assessed by evaluations of the local skin     response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.      Safety will be evaluated by adverse events and local skin responses reported during the study   "
50652|NCT02622581|"     Open, non-interventional, prospective, multi-center clinical research platform with the main     objective to assess molecular biomarker testing, treatment and outcome of patients with     advanced or metastatic NSCLC in Germany   "
50653|NCT02622568|"     The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a     single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment     and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the     pediatric population. The investigators will compare the single and combination treatment     modalities over identical time points in patients with non-facial verruca vulgaris. One of     the current options for care for non-facial verruca includes cryotherapy, which is a painful     and destructive method performed in the pediatric dermatology clinic. This study aims to     establish the safety, non-invasivenature, efficiency, and efficacy of Veregen ™ 15% ointment     as monotherapyfor non-facial verruca vulgaris in the pediatric population. The investigators     hypothesize that Veregen ™ 15% ointment monotherapy will non-invasively treat non-facial     verruca vulgaris with similar efficacy as combination therapy with a single cryotherapy     treatment followed by topical application of Veregen ™ ointment. This novel treatment     modality will be useful in the pediatric dermatology community offering a less invasive,     painless option for treatment of non-facial verruca vulgaris.   "
50654|NCT02622555|"     Overactive bladder syndrome complicates life for many women. 60-70% of women report     improvement with treatment but the antikolinergic treatment is often limited by the adverse     events, for example dry mouth, obstipation and urinary retention. Mirabegron is a     b3-adrenoreceptor agonist which induces detrusor relaxation. Earlier studies has demonstrated     similar efficacy comparing Mirabegron with antimuscarinics but a significant reduction of     adverse events. The aim of the present study is to survey cardiovascular adverse events with     Mirabegron treatment in a general population suffering from overactive bladder syndrome.   "
50655|NCT02622542|"     The purpose of the study is to conduct a randomized controlled trial comparing best medical     therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for     uncomplicated acute type B aortic dissection.   "
50656|NCT02622529|"     This study aims to investigate patients' experience of awake surgery of the brain. Patients     therefore must suffer a disease that makes the technique of awake craniotomy necessary.      In more detail, the investigators are performing this study in order to investigate the     influence of fear on pain perception during surgery for patients undergoing awake surgery for     lesions within the brain. In the event of finding a correlation between fear of the surgery     and intraoperative pain perception, the investigators aim to reduce possible fear beforehand.      An additional goal of the investigators is to identify psychological consequences of awake     craniotomy timely and admit patients to an adequate therapy if necessary.      There will be no changes regarding the actual treatment of the disease. In case of a consent,     the patient will receive questionnaires at three timepoints: 1. day before surgery. 2. third     day after surgery. 3. at 3-6 months postoperatively at the outpatient clinics.      The benefit of participating in this study is the possibility of detecting psychological     consequences of awake craniotomy at an early stage. If required, patients will then receive     treatment timely.      There are no additional risks. Theoretically there is only a data risk after analysis.      Patients are free to decide if they want to participate within this study. There are no     changes in the actual treatment if patients deny participation. In case of participation,     patients have the right to quit at any time with no reasoning at all.      During the study investigators are collecting health-related data. If patients quit before     the study end, data will still be used in pseudonymized form. After 10 years, data will be     destroyed.      In case of participation the only duty for the patient is to fill out the questionnaires at     the above mentioned three time points.      The investigators conduct this study based on all rules of law regarding data protection.     Investigators only use the collected data in relation to this study. All investigators are     under obligation to secrecy.   "
50658|NCT02622503|"     The purpose of the study is to obtain an overall picture of rituximab treatments and     treatment responses in RA patients.   "
50659|NCT02622490|"     Thirty participants without serious concomitant diseases consume either a high- or a low     carb. meal either as one single meal or as 5 small portions in the morning and are tested for     effects on major cardiovascular risk markers and on metabolic rate for three hours on each     occasion.   "
50660|NCT02622477|"     The purpose of the study was to assess the clinical outcome of patients with a mild to     moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).   "
79468|NCT02245711|"     The purpose of this study was to study the effect of stem cell therapy on Limb Girdle     Muscular Dystrophy patients.   "
50663|NCT02622438|"     On the basis of published data and our results indicating that oxidative stress may     contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators     conducted a pilot randomized double-blind placebo controlled trial to test whether oral     administration of vitamins and mineral could improve the physical performance of patients     with FSHD.The result of this clinical trial showed that antioxidants supplementation may     improve skeletal muscle function of patients with FSHD and suggest that an antioxidant     strategy adapted may be a relevant therapeutic approach for these patients. Since then,     patients with FSHD who attend consultation at Montpellier hospital are systematically     supplemented with antioxidants according their own blood tests.   "
50664|NCT02622425|"     This randomized, placebo-controlled trial aims to determine the effects of daily     administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on     cardiovascular health biomarkers, microbiota composition and functioning and intestinal     barrier function in overweight subjects.   "
50691|NCT02622074|"     The purpose of this study is to evaluate the safety, tolerability and clinical activity of     pembrolizumab (MK-3475) in combination with six chemotherapy regimens as neoadjuvant     treatment for participants with triple negative breast cancer (TNBC).      The primary objectives of this study are: 1) to determine the safety and tolerability and 2)     to establish a recommended Phase 2 dose for the six combination regimens as a neoadjuvant     treatments for participants with TNBC.   "
50665|NCT02622412|"     Breathlessness is a common and distressing symptom in patients with advanced diseases like     cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung     fibrosis, which broadly impacts on patients' quality of life and may result in high burden     for carers.      This single-blinded randomized controlled fast track trial evaluates the effectiveness of a     multi-professional breathlessness service in patients with advanced and chronic diseases. The     intervention group will get immediate access to the breathlessness service whereas the     control group will receive standard care and get access to the service after a waiting time     of eight weeks. Primary endpoints are mastery of breathlessness and quality of life, measured     with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of symptom burden     of patients and burden of carers. The evaluation of the cost effectiveness of the     breathlessness service from the perspective of the German health system is a further study     aim.   "
50666|NCT02622399|"     Caregiver social isolation adversely impacts child health and developmental outcomes; it also     contributes to suboptimal engagement in health care services and enrichment resources, which     also elevate risk for poor outcomes in childhood. The proposed pilot intervention aims to     reduce social isolation and promote engagement in health promoting enrichment and activities,     by embedding a community health worker assisted forum in a community-driven mobile     communications (using a platform supported by the company txtwire).      The investigators propose a two-arm, pilot study enrolling 100 parents of children age 0-5     years old who reside in the Roxbury, Dorchester, and Mattapan neighborhoods of Boston.     Participants will be recruited from Boston Medical Center and community sites in Roxbury,     Dorchester, and Mattapan. The investigators will use quality improvement methods to improve     the utilization of the mobile communications shared through txtwire to build collective     efficacy for children and social support and engagement that will optimize family resiliency     and thereby promote child well-being, as well as, assess the acceptability of the     intervention, and logistics of the field implementation to ultimately inform an appropriately     powered RCT. Participants will receive compensation for participation at baseline and     follow-up interviews.      The intent of this study is to support developement of mobile social communications to reduce     social isolation.   "
50667|NCT02622386|"     The purpose of this study is to determine the anti-inflammatory effect of high-dose     riboflavin supplementation on chronic plaque psoriasis. Psoriasis is a common chronic skin     disorder that affects over 4 million people. There is no cure for psoriasis and treatment is     directed at controlling patients' symptoms. Amongst patients with skin disease, there is     significant interest in using complementary alternative medicine and vitamins to treat their     disease. Previous human case reports suggest that riboflavin, commonly known as Vitamin B2,     is clinically effective for the treatment of psoriasis; however, they were not conclusive.     More recent human trials have shown that 400 mg of daily oral riboflavin is a safe and     well-tolerated medication to administer to humans. For the purpose of this study, the     riboflavin is used as an investigational drug.   "
50668|NCT02622373|"     The purpose of this study is to gain information that may be useful in helping to figure out     better or newer ways to provide nutrition to babies born premature.   "
50669|NCT02622360|"     Developmental dyslexia is a highly heritable disorder in which reading skills are compromised     despite normal intelligence and appropriate reading instruction. Reading problems in dyslexia     are thought to primarily originate from weak speech sound representations or poor     phonological skills. Dyslexia has also been associated with short-term or working memory     dysfunctions. The current study will address the presence of these problems in dyslexic     adults by the means of recording auditory and audio-visual mismatch negativity (MMN) and its     magnetic counterpart (MMNm) to determine neural speech sound discrimination, representations     and integration of seen and heard language. In addition to analyzing neural processing of     syllables or (pseudo-)words, a new approach to MEG acquisition and analysis to characterize     the neural responses during comprehension of complex real-life speech will be used.     Furthermore, reading, phonological and cognitive skills of these participants will be     determined with a neuropsychological test battery. The associations between the neural,     neuropsychological and genetic measures will be studied. This project will illuminate the     nature of neurocognitive dysfunctions in dyslexia and their relationship with genes.   "
50670|NCT02622347|"     The purpose of this study is to test the validity of our in-house chemiluminescence assay for     measurement of folliclestimulating hormone (FSH) serum levels before and during exogenous     recombinant FSH (rFSH) administration.   "
50671|NCT02622334|"     The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151     following 7 days of topical ocular treatment in patients with primary open angle glaucoma or     ocular hypertension.   "
50683|NCT02622178|"     The main goal of this study is to evaluate the sensitivity and specificity of the NOVA-DN VEP     protocol and a new software and method (Corda) for the glaucoma detection using optical     coherence tomography images. Another objective is to evaluate the sensitivity and specificity     of these tests to differentiate between normal subjects and glaucoma suspects.      The hypothesis is that the NOVA-DN VEP protocol and Corda analysis results in a high     sensitivity, specificity and area under the receiver operating characteristic (ROC) curves     (ROC area) for the glaucoma detection. Another hypothesis is that the NOVA-DN VEP protocol     and some Corda parameters can differentiate between normal subjects and glaucoma suspects.   "
50687|NCT02622126|"     Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention     of spinal hypotension appears more likely to decrease the frequency and severity of     associated adverse maternal symptoms than the treatment of established hypotension.     Intravenous fluid administration prior to spinal anesthesia for caesarean section is accepted     standard practice. The choice of fluid depends on individual and institutional habit,     material cost (crystalloid is considerably cheaper) and the perceived relative benefits and     risks. Uncommon but potentially serious adverse effect of colloids is impaired coagulation.     Although pregnancy is associated with hypercoagulability, little is known about the effects     of colloid preloading on coagulation in pregnant patients.   "
50688|NCT02622113|"     This extension study was designed to evaluate the safety and efficacy of Canagliflozin     (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The     extension study was an extension to double-blind study of 16 weeks (TA-7284-11)   "
50672|NCT02622321|"     This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of     prophylactic emicizumab treatment in participants previously treated with episodic or     prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a     2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will     be stratified across Arms A and B according to the number of bleeds they experienced over the     last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>/=] 9     bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis     after 24 weeks on-study. Prophylactic bypassing agent participants will switch to emicizumab     prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks     after the last participant has enrolled in Arms A or B or until approximately 50 participants     have enrolled in Arm C, whichever occurs first. Episodic bypassing agent participants who     previously participated in the non-interventional study BH29768 (NCT02476942) or prophylactic     bypassing agent participants who were unable to enroll in Arms A, B, or C prior to their     closure will have the opportunity to enroll in Arm D. Like participants in Arms A and C, Arm     D participants will receive emicizumab prophylaxis from the start of the trial. All     participants will continue to receive episodic bypassing agent therapy to treat breakthrough     bleeds, preferably with rFVIIa at the lowest expected dose to achieve hemostasis.   "
50673|NCT02622308|"     This experimental study will look at the effects of INP therapy for two patient groups: 1)     patients with reduced peripheral circulation and chronic wounds in patients with renal     disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project     is designed as a non-randomized clinical trial with single-subject multiple baseline design.     Also the intervention will be subjected on the same leg for each individual throughout the     study period. The other leg will act as a control. A baseline measure with patient history     collection will be performed before a four-week intervention period. These measures include:     Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler     sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health     survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the     same tests will be repeated. A final follow-up test will be two weeks after cessation of the     intermittent negative pressure intervention. The study will look at the effect of INP on     renal failure patients who are given dialysis at a dialysis center located at Oslo University     Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary     training to perform this project. Outcome variables assessed before, during and after the     10-week study period will be: wound healing, quality of life, skin perfusion pressure and     segmental pulse-volume recording. The aim of this project is to prospectively examine and     elucidate the effect of intermittent negative pressure therapy on clinically relevant     measures related to the reduction of peripheral macro- and microcirculation in patients with     renal failure undergoing dialysis treatment.      The hypothesis of the study is:        -  Application of INP in patients with renal failure, by the use of the FlowOx™ device,          will improve wound healing and peripheral circulation in the foot compared to before          treatment (baseline) in patients undergoing dialysis treatment.        -  Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve          macro- and microcirculation and wound healing in the foot compared to before treatment          (baseline) in patients with chronic wounds.   "
50674|NCT02622295|"     Patients with spinal cord injury (SCI) experience metabolic syndrome, diabetes, obesity,     pressure ulcers, and cardiovascular disease at far greater rates than the general population.     A rehabilitation method to prevent or reverse the systemic metabolic consequences of SCI is a     pressing need. The purpose of this study is to determine the dose of muscle activity that can     enhance an oxidative muscle phenotype and improve clinical markers of metabolic health and     bone turnover in patients with SCI. The long-term goal of this research is to develop     exercise-based interventions to prevent secondary health conditions such as diabetes and to     ultimately protect health-related quality of life (QOL). Specific Aim 1: To compare changes     in skeletal muscle gene regulation in individuals who receive high frequency (HF)     active-resisted stance and low frequency (LF) active-resisted stance for 16 weeks. We     Hypothesis 1: The expression of genes regulating skeletal muscle metabolism will support that     HF and LF both instigate a shift toward an oxidative muscle phenotype. A novel finding will     be that LF is a powerful regulator of oxidative pathways in skeletal muscle. Specific Aim 2:     To compare changes in systemic markers of metabolic health and bone turnover in individuals     with SCI who receive HF or LF for 16 weeks. Hypothesis 2: HF and LF will both reduce     glucose/insulin levels and HOMA (homeostasis model assessment) score. However, only HF will     demonstrate an effect on bone turnover (higher serum levels of osteocalcin). Secondary Aim:     To measure subject-reported QOL using the EQ-5D survey metric. Hypothesis 3: HF and LF     subjects will show a trend toward improved self-reported QOL after 16 weeks. There will be an     association between metabolic improvement and improved perception of QOL. These observations     will support that this intervention has strong feasibility for future clinical translation.   "
50675|NCT02622282|"     The purpose of this study is to learn about the impact of text messaging on physical activity     in persons with risk factors for peripheral arterial disease (PAD).   "
50676|NCT02622269|"     Compression of the abdomen during urography with either a patient-regulated compression     device or conventional compression.      Evaluation of radiation dose, image quality and patients' experiences   "
50677|NCT02622256|"     Cardiovascular (CV) disease is associated with significant morbidity and mortality. In the     current digital age, needed is a better understanding of how information on social media     sites may inform our approaches to improving CV health through novel methodologies.     Investigators propose to study the conversation on Twitter about several CV diseases and     their associated sequelae.   "
50678|NCT02622243|"     The study will assess the duration of protection of single doses of 2 different long acting     muscarinic antagonists against methacholine induced bronchoconstriction.   "
50679|NCT02622230|"     The purpose of this study is to determine the safety and tolerability, and to evaluate the     pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in     healthy adult subjects.   "
50680|NCT02622217|"     Sleep deprivation is common in anaesthesiology residents. Its effects on technical skills     have been reported with controversial results. Non-technical skills (team working, situation     awareness, decision making and task management) contribute to safe and efficient task     performance. They have a crucial role in anaesthetic practice, especially during crisis     management. The investigators hypothesized that sleep deprivation was associated with a     reduced mobilisation of non-technical skills in anaesthesiology residents.   "
50681|NCT02622204|"     Our overall hypothesis is that a sudden ambulatory load reduction (caused by HTO) leads to     changes in cartilage biology that delay or reverse osteoarthritic processes determining the     clinical outcome and representing an in vivo model for assessing cartilage     mechanosensitivity.   "
50682|NCT02622191|"     The investigators aims to further the understanding of glaucoma pathogenesis and progression     by utilizing both enhanced depth imaging optical coherence tomography to visualize and     measure the lamina cribrosa in vivo and segmentation technology to accurately delineate and     measure the boundaries of the retinal layers. The investigators will elaborate further on the     key concepts of lamina cribrosa thickness and transynaptic degeneration.   "
50684|NCT02622165|"     The aim of this study is to conduct an outcome and process evaluation of the REWARD     intervention, a serious game intervention using reward-based strategies as a main method to     trigger healthy snacking in Flemish adolescents.   "
51803|NCT02607553|"     An open-label, single-arm, single-center Phase II study to evaluate the safety and activity     of G-202 in patients with clear cell renal cell carcinoma that expresses PSMA   "
50692|NCT02622061|"     This is a multi-centre, single visit clinical investigation involving patients with known PCD     vs. age matched healthy volunteers. This study involves 1 visit which will last one (1) to     two (2) hours. Participants (and parent as applicable) will be asked for their consent to     participate in the study. A brief medical history will be recorded, including information     such as age, gender, height, weight, race, current medications and living environment. If the     participant is a PCD patient, they will also be asked about their disease history. Prior to     performing the nasal measurements, participants will receive instructions from study     personnel and have the opportunity to practice. All participants will have a brief nasal exam     and will also have to blow their nose before starting the measurements. Participants will be     asked to perform nasal nitric oxide measurements using the tidal breathing method followed by     the velum closed with expiration against resistance method.      The primary objective is to determine the feasibility and capability of the NIOX VERO to     discriminate participants with PCD from those that are healthy. Information collected in this     study will help researchers understand more about the diagnosis of and identification of     patients with PCD.   "
50693|NCT02622048|"     The purpose of this trial is to explore parent-child interactions in parents with and without     psychosis, and ascertain whether a brief (10 week) supported self-help parenting program     offered to parents in their own homes can help improve parents' self-efficacy and general     well-being, as well as interpretations of their parent-child relationship and child behaviour     in children who are 3-10 years old.   "
50694|NCT02622035|"     Background:      We are involved in testing new behavioral science methods and measures for future research     projects. In the course of these evaluations, we will also test research questions related to     parents psychological experiences and how these relate to the responses they have when they     encounter different types of communication about child health. We are testing multiple     research questions in the course of this research.      Objective:      - To learn about technologies and approaches to use in future research studies.      Eligibility:      - Parents (fathers and mothers) of children between the ages of 3-7.      Design:      As part of the main study, participants will do four tasks:      Task 1: Before participants arrive for an in-person visit, they will answer questions online     about themselves, their child, and their thoughts and opinions related to health.      Task 2: At the in-person visit, participants will watch a short scene from a movie and answer     some questions      Task 3: At the in-person visit, participants will read information about a child health topic     and answer questions      Task 4: At the in-person visit, participants will use a virtual reality-based buffet     restaurant simulation to make hypothetical food choices for their child   "
50695|NCT02622022|"     36 patients with interstitial lung disease will be randomized to 1 weeks treatment with     morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4     times a day, or corresponding doses of placebo.      VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other     questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)   "
50696|NCT02622009|"     Background: The presence of low-grade viral infection in the airways of patients with stable     chronic obstructive pulmonary disease (COPD) could potentially have implications in the     pathogenesis and progression of the disease, but previous studies have reported very     different rates of human rhinovirus (HRV) and respiratory syncytial virus (RSV) genome     detection in nasal and sputum samples. However, no study has investigated the presence of     these viruses directly in the lungs by bronchoalveolar lavage (BAL) and bronchial biopsies.     This study aimed to investigate whether HRV and RSV are present in the lungs of stable COPD     patients by performing BAL and bronchial biopsies, and relate their presence with disease     severity.      Methods: Consecutive patients with stable COPD and control subjects, who underwent diagnostic     (e.g., lung cancer) and/or therapeutic (e.g., hemoptysis) fibreoptic bronchoscopy in a     university hospital in Athens, Greece, were enrolled. The collected BAL and bronchial     biopsies during bronchoscopy were subsequently processed for HRV and RSV RNA detection with     real-time polymerase chain reaction (PCR). More specifically, the nucleocapsid gene and 5΄     non-coding region were searched for RSV and HRV detection, respectively.   "
50770|NCT02621047|"     This is a multicenter, non-randomized, single-dose, open-label study conducted in male and     surgically sterile or post-menopausal female participants with stable chronic hepatic     impairment and in healthy participants matched by age, gender, and body weight to assess the     effect of hepatic impairment on the pharmacokinetics of alectinib.   "
50697|NCT02621996|"     The individual who is born premature, in addition to a CNS still in accelerated training     suffers early loss of intrauterine restraint, conditions that promote hypotonia     characteristic of premature birth. Given this hypotonia associated with musculoskeletal     immaturity when improperly positioned in the incubator for an extended period, the PN can     develop joint contractures and postural imbalances that, in most cases, are transitory,     however can become persistent, causing delay in their Motor development. The aim of this     study is to analyze the influence of the positioning of preterm infants in the incubator     hammock on the tone and the myoelectric activity of the rectus abdominis flexor muscles,     biceps and hamstrings. Study type controlled, randomized, double-blind, to be carried out     from November 2015 to April 2016 will be obtained two groups, control (in containment nest     U) and experimental (with hammock) to from randomized samples with premature births in     Barao de Lucena Hospital or the Hospital das Clinicas, UFPE, the Intermediate Care Units     (ICU) Neonatal. The sample will consist of 30 premature. To collect, pulse oximeter will be     used, electromyography, neurological testing Dubowitz and recording behavioral responses.     Each baby will be accompanied for about 8 hours daytime placement for two days and three     evaluations performed.   "
50698|NCT02621983|"     This study will evaluate the ability of aerobic exercise to improve cognition in people with     schizophrenia. Participants will be randomly assigned to one of two interventions: (1)     aerobic exercise class (stationary bicycle, or spin class) for up to 45 minutes three times     per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times     per week for 12 weeks.   "
50699|NCT02621970|"     The investigators aim to evaluate the survival benefit from triple combination of induction,     concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk     locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated     radiotherapy.   "
50700|NCT02621957|"     This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and     without concomitant GDC-0810 administration in healthy female subjects of non-childbearing     potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined     in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be     determined in the presence of GDC-0810.   "
50701|NCT02621944|"     Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates     treated with the state of the art therapy (induced systemic hypothermia) have normal     outcomes. Therefore, other promising therapies that potentially work in synergy with     hypothermia to improve neurologic outcomes need to be tested. One potential agent is     melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal     gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has     many other effects that may benefit infants with HI injury. Melatonin serves as a free     radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes.     Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in     turn minimizing cell death and improving outcomes. The research study will evaluate the     neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing     therapeutic hypothermia for hypoxic ischemic encephalopathy.   "
50702|NCT02621931|"     The study is being conducted to evaluate two doses of TEV-48125 in adult patients with     chronic migraine   "
50703|NCT02621918|"     We aimed to investigate the effect of a progressive resistance training and aerobic training     protocol on functional capacity, body composition and quality of life.   "
50704|NCT02621905|"     The pharmacokinetics of Sporanox and Lozanoc has not been compared in patients requiring     anti-fungal prophylaxis or therapy. The present study is designed to compare the     pharmacokinetics of Sporanox and Lozanoc in patients requiring primary prophylaxis. The     3-week exposure to each formulation is designed to allow for all participants to reach     steady-state for each drug, as the time to steady-state can vary.   "
50705|NCT02621892|"     This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will     evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant     irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active     disease as determined after a two-week screening period. Subjects who qualify and are     randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12     week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.   "
50706|NCT02621879|"     Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in     Treatment of Recurrent Sacrococcygeal Pilonidal sinus   "
50707|NCT02621866|"     The investigators have shown that a single dose of ultraviolet irradiation (as found in     sunlight) will lower blood pressure for around one hour. They are now testing whether daily     UVA for two weeks will produce a sustained fall in BP in patients with high blood pressure.      They will also measure the effect of daily UVA on other cardiovascular risk factors.   "
50708|NCT02621853|"     Fatty liver disease including liver steatosis (fat deposition) is a major health problem     worldwide. It is considered pathological when fat accumulation exceeds 5% of the liver     weight. Transplantation represents the ultimate treatment for end stage liver disease.     However, the discrepancy between the demand for donor organs and their availability presents     one of the greatest hurdles of liver transplantation. Therefore, extended criteria organs     have to be considered to overcome this shortcoming. Hepatic steatosis is one of the most     important criteria defining extended-criteria donor liver. In liver transplantation, 'severe'     fat deposition in donor liver is a major cause of graft failure while 'mild' deposition is     considered transplantable and 'moderate' deposition represents the gray zone and remains     difficult to assess. Surgeons usually perform a hepatic steatosis assessment during liver     donor surgery. However, this method is very subjective and difficult especially when     inexperienced surgeons or trainees are concerned. Furthermore, it has recently been     documented that the assessment of steatosis is challenging even in the hands of experienced     surgeons. Theoretically, a better way to assess steatosis before organ procurement would be a     non-invasive imaging technique. However, some of these techniques appear to lack the     sensitivity to accurately quantify hepatic fat content while others are complex, expensive     and inconvenient to use in the setting of organ procurement. Therefore, liver biopsy remains     the reference for grading hepatic steatosis. In daily practice the assessment and     quantification of steatosis by a pathologist during organ procurement is more complex related     to the lack of availability of dedicated hepatopathologists outside of office hours and in     smaller community hospitals. A simple and short technique is therefore required to assess     liver steatosis before retrieval. We have recently demonstrated that Raman spectroscopy could     provide an accurate, rapid and real-time assessment of hepatic fat content and correlated     highly with the gold standard (i.e. histopathological assessment of liver sections) in an     animal model of liver steatosis. The purpose of this study is to validate the use of Raman     spectroscopy for quantitative assessment of hepatic steatosis. In the hands of the surgeons     this device can provide an immediate, robust tool to assess the suitability of donor livers     at the site of retrieval prior to liver transplantation.   "
50771|NCT02621034|"     In this study the investigators aim to compare the post-operative pain using two single-file     endodontic rotary systems : Reciproc and One shape.   "
50709|NCT02621840|"     The investigators aim to investigate the impact of mandating on-site pre-admission testing on     cataract cancellation rates in a randomized, prospective, intervention study. Cataract     extraction is the most commonly performed ocular surgery making surgical training an integral     component of ophthalmology residency. Patient cancellation of surgery results in a financial     burden to the institution and a loss of essential educational experiences for the residents.     An earlier study explored variables impacting cancellation rates and identified incomplete     pre-admission testing as a major contributing factor to surgery cancellation.      Patients will be randomized to either 1) the intervention group where on-site pre-admission     testing will be mandated or 2) the control group, where on-site pre-admission testing will be     offered but not mandated. Cancellation rates will be collected prospectively and statistical     analysis utilized to evaluate the significance of intervention.   "
50710|NCT02621827|"     This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in     non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months     post-partum in women who are exclusively breast-feeding.   "
50711|NCT02621814|"     The purpose of this study is to assess the infants' growth rate and incidence of feeding     intolerance fed by Friso formula compared with Wyeth S26 formula.   "
50712|NCT02621801|"     This prospective, waitlist-control study is evaluating the benefits of a stress management     and resiliency training program for residents (SMART-R).      The primary aim of this study is to determine whether the SMART-R is effective at increasing     coping skills and reducing stress among residents, reflected by changes in constructs such as     emotional growth, perceived stress, optimism, and coping styles. Objective parameters (heart     rate, galvanized skin response, sleep duration and quality, exercise and actigraphy) measured     with the Basis health tracking device will help correlate objective signs to subjective     report of stress.   "
50713|NCT02621788|"     This prospective pilot study evaluated the benefits of a stress management and resiliency     training program for residents (SMART-R).      The primary objective of this study is to determine whether the SMART-R effectively reduces     burnout and stress and enhances coping skills in first year residents. Objective parameters     (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy)     measured with the Basis health tracking device will help correlate objective signs to     subjective report of stress.      The investigators' hypothesis is that the SMART-R, a curriculum designed to teach first year     residents (in the department of Medicine and Psychiatry) relaxation skills, will enhance     residents' emotional and physical well being, reduce reports of stress, anxiety, depression,     and physical complaints, as well as increase overall resiliency.   "
50714|NCT02621775|"     The aim of this study was to assess the effects of a 5-week standardized cognitive behavioral     treatment of stress management conducted via e-learning or face-to-face on patients     responding to the diagnosis of adjustment disorder with anxiety (ADA) according to the DSM- 5     (Diagnostic and Statistical Manual of Mental Disorders Fifth Edition) criteria .   "
50715|NCT02621762|"     The study aims to determine the effect size of magnesium and bicarbonate supplementation as a     basis for future randomized controlled trials aiming at the T50-guided improvement of hard     clinical endpoints in dialysis patients.   "
50716|NCT02621749|"     The primary objective of this study is to investigate the impact of continuous renal     replacement therapy and intermittent renal replacement therapy on microbubble / cerebral     microemboli generation in a cohort of critically ill patients with dialysis-dependent acute     kidney injury.   "
50717|NCT02621736|"     Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of     all 7 year olds. MEN is often leading to psychosocial problems because of its burden and     stigmatism.      The only available medical treatment option is the vasopressin analogum Desmopressin®.     However, according to the literature, only one third of patients shows a good treatment     response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with     Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side     effects like water intoxication and hypertension.      Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in     patients with MEN compared to controls and lower in patients with severe bed wetting compared     to patients with only slight bed wetting.   "
50718|NCT02621723|"     CURIOS@ is a prospective multi-centre cross-sectional study to investigate readmissions in     participating units. The data collected is derived from two clinical episodes: the episode     containing the re-admission and the previous admission (index admission).      The main aims are:      Outcomes:        -  Risk factors to predict preventable readmissions in non-surgical patients        -  Percentage of subjectively non-preventable and preventable readmissions from patient,          carer, their nurses and their physician's point of view        -  Comparison for risk factors on readmissions throughout Europe        -  Increasing awareness and knowledge for health-care workers on readmissions and its          preventability   "
50719|NCT02621710|"     This study evaluates patient goal achievement and satisfaction in benign hysterectomy.     Patient's will state their goals prior to undergoing benign hysterectomy, and will receive a     follow-up questionnaire 3 months post-operatively evaluating their perception of goal     achievement and overall satisfaction. Goal achievement and satisfaction will be evaluated for     association with surgical indication, surgical approach (minimally invasive vs abdominal     surgery), and demographic information.   "
50720|NCT02621697|"     Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task) in     the risk of falls, balance, independence in basic activities of daily living (BADL) and     handgrip in institutionalized elderly.      Methods: The sample was divided in two groups: double task group (DTG), consists of five     elderly, undergoing a training consists of motor and cognitive activities and control group     (CG) consists of four seniors who underwent conventional kinesiotherapeutic training, based     on global stretching and strengthening exercises, both held in 16 sessions.   "
50781|NCT02620904|"     Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or     placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational     age or greater.      Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when     compared to placebo, and in conjunction with other pharmacologic methods for induction of     labor.      Expected outcomes: The addition of a progesterone receptor modulator will expedite time to     delivery of the fetus and ultimately improve the experience associated with induction of     labor for fetal demise.   "
50721|NCT02621684|"     The purpose of this pilot study is to evaluate the feasibility of recruiting African American     prostate cancer survivors to a 12 week physical activity intervention study of three arms     (aerobics, resistance training, and usual care) through physician referral and community     advertisement strategies. In addition, the investigators will investigate the acceptance rate     of the intervention and gather preliminary results on the effect of exercise on African     American men's urinary and sexual functions. These data can then be used to refine the     intervention and its implementation model, and to inform the submission of a larger grant to     the National Institutes of Health.   "
50722|NCT02621671|"     Epidemiology seeks to improve public health by identifying risk factors for cancer and other     diseases and conveying that information to relevant audiences. The audience is presumed to     understand and use that information to make appropriate decisions about lifestyle behaviors     and medical treatments. Yet, even though a single risk factor can affect the risk of multiple     health outcomes, this information is seldom communicated to people in a way that optimizes     their understanding of the importance of engaging in a single healthy behavior. Providing     individuals with the ability to understand how a single behavior (obtaining sufficient     physical activity) could affect their risk of developing multiple diseases could foster a     more coherent and meaningful picture of the behavior's importance in reducing health risks,     increase motivation and intentions to engage in the behavior, and over time improve public     health.      The proposed study translates epidemiological data about five diseases that cause significant     morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes,     and stroke) into a visual display that conveys individualized risk estimates in a     comprehensible, meaningful, and useful way to diverse lay audiences.   "
50723|NCT02621658|"     Colorectal cancer is the third most common cancer diagnosed in both men and women in the     United States. The death rate from this disease, however, has been decreasing over the last     20 years. Early detection and removal of pre-malignant polyps is considered to be at the core     of this change. At the same time, polyp detection is highly dependent on an adequate bowel     preparation. Froehlich, et al., found that poor bowel preparation is associated with longer     colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).      Although a Clear Liquid Diet is usually the prescribed diet in most bowel preparation     regimes, several studies have shown similar results with less restrictive diets.      Based on the hypothesis that a Full Liquid Diet(FLD) is not inferior to a Clear Liquid     Diet(CLD), investigators plan to conduct a prospective, randomized trial, in order to compare     these dietary interventions. The investigators and endoscopists will be blinded to patient's     diet group.      Researchers aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is     associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD).     Investigators will compare the performance of these dietary interventions regarding adenoma     detection rates(ADR), time to cecal intubation(TCI), and colonoscope withdrawal time. In     addition, the investigators want to assess whether patient's Compliance and Satisfaction is     similar or superior in the experimental group vs the control group.   "
50724|NCT02621645|"     Multi-center open-label randomized controlled trial to assess if early intervention     (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late     intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women     diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late     intervention group (1:1), using a web-based application and a computer-generated list with     random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational     age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by     intention to treat.   "
50725|NCT02621632|"     The study intends to investigate a novel compression system termed Socknleg composed of an     understocking covering the foot with three added stockings extending from the ankle to the     knee without covering the foot. The novel Socknleg system is compared to a standard class III     compression stocking.   "
50726|NCT02621619|"     To determine the efficacy of IV acetaminophen as an analgesic adjunct to IV hydromorphone in     the treatment of acute severe pain in the elderly ED patients.   "
50727|NCT02621606|"     The purpose of this open-label, 3-part study is to investigate the safety and efficacy of     [11C]MK-6884 as a Positron Emission Tomography (PET) imaging agent for quantifying muscarinic     4 (M4) positive allosteric modulator (PAM) receptor density in brain regions of interest. The     study will enroll healthy participants (Parts I and II) and participants with Alzheimer's     Disease (AD)(Part III). The primary efficacy hypothesis is that the average intra-subject     test-retest (T-RT) variability of tracer uptake in brain regions of interest is ≤20%.   "
50728|NCT02621593|"     The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction     (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in     dry eye symptoms post-treatment, compared to pre-treatment.   "
50729|NCT02621580|"     Laser therapy is an established method to stabilize and control proliferative diabetic eye     disease. Questions on the long-term effect on the retina from these treatments remain to be     answered. The purpose of the study was to evaluate changes in the retina following panretinal     photocoagulation (PRP) over time, using structural and functional diagnostic tests.   "
50730|NCT02621567|"     Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute     Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to     assess the feasibility of conducting a full trial which would assess the efficacy of Bright     Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary     syndrome.   "
50731|NCT02621554|"     The study will investigate whether resveratrol could provide positive effects on memory and     brain structures and functions in healthy elderly participants.   "
50782|NCT02620891|"     Helium—oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome     in previous studies，but the evidence was limited．The aim of the study was to assess the     effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70%     helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in     meconium aspiration syndrome.   "
50783|NCT02620878|"     The purpose of this study is to determine safety, feasibility and efficacy (with respect to     sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night     closed-loop control in children and adolescents with type 1 diabetes.   "
50732|NCT02621541|"     Predicting aggressive behavior in the group of nonfunctional pancreatic neuroendocrine tumors     (NF P-NET) remains a difficult problem in clinical practice. At present, the treatment     planning in P-NET is significantly restricted by the limited results of conventional imaging.     In addition, increasing use of multidetector computed tomography (MDCT) and magnetic     resonance imaging (MRI) is increasing the number of NF P-NETs detected. Somatostatin receptor     scintigraphy (SRS) combined with anatomical imaging are the conventional modalities in     imaging of P-NET, but by these methods the diagnostic accuracy still remains compromised.     Furthermore, recently encouraging results have been obtained in P-NET using 68Ga-labelled     somatostatin analog, DOTA-1-NaI3-octreotide (68Ga-DOTANOC) positron emission     tomography-computed tomography (PET-CT).      The aim of the current project is to evaluate the possibility to enhance the diagnostic     accuracy by using dual trace functional imaging 18F-labelled fluorodeoxyglucose (18F-FDG) and     68Ga-DOTANOC PET-CT imaging in patients with NF P-NET. The study consists of 20 patients with     NF P-NET. The patients enrolled in the study will be imaged 68Ga-DOTANOC and 18F-FDG PET-CT     followed by surgery or follow-up with endoscopic ultrasonography (EUS) biopsies. The data     will be collected between autumn 2015 and spring 2018.   "
50733|NCT02621528|"     The purpose of this multi-center, non-interventional, prospective, post-market clinical study     is to collect real world data on patient outcomes and evaluate the procedural success and     performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum     Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).   "
50734|NCT02621515|"     The effect of nivolumab on symptomatic brain metastases is currently unknown. This phase 2     clinical trial will be the first to evaluate this intracranial effect in humans, with the aim     to give these patients the possibility to be treated with anti-PD-1. Besides the objective     response rate, long term benefits in this patient category will be evaluated by measuring     survival in terms of progression free survival and overall survival. Furthermore safety and     tolerability of administration of this drug in patients with symptomatic brain metastases     will be studied, as this is the first study for nivolumab in this specific patient category.   "
50735|NCT02621502|"     The purpose of this study is to to assess the glycemic index and the satiating properties of     different Quinoa varieties, using a Visual Analogue Scale in a sample of healthy overweight     subjects.   "
50736|NCT02621489|"     The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize     vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI)     and to accelerate stent endothelialisation.   "
50737|NCT02621476|"     The investigators propose a randomized encouragement trial to encourage use of the existing     mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor     medications in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim,     and Kaiser Permanente Hawaii.   "
50738|NCT02621463|"     Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP)     ventilator approach using an FDA approved ventilator.   "
50739|NCT02621450|"     End stage renal disease (ESRD) is related with increased cardiovascular mortality and     morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among     hemodialysis (HD) patients. The aim of this study going to investigate the effectivity of     low-sodium dialysate on the systolic and diastolic blood pressure (BP) levels detected by     ABPM and interdialytic weight gain (IDWG) in patients undergoing sustained hemodialysis     treatment.      Methods: The study will be included 46 patients who had creatinine clearance levels less than     10 ml/min/1.73 m2 and had been on chronic HD treatment for at least one year. After the     enrollment stage, the patients will be allocated low-sodium dialysate or standard-sodium     dialysate for six months via computer-generated randomization.   "
50740|NCT02621437|"     Breast cancer can be painful following surgery or can develop later and remain persistent.     Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity     with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is     to preserve quality of life.      Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease,     treatments and their side effects (asthenia, anxiety and pain).      The main objective is to assess the impact of osteopathic treatment on pain in patients     following breast cancer surgery. The impact will be considered beneficial if the pain score     (digital scale) in the intervention group is lower, by at least two points, than the pain     score in the control group at the end of the study.      This is a monocentric, randomized, parallel group, single-blind and prospective clinical     trial.   "
50741|NCT02621424|"     The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves     cognitive function in patients with neurodegenerative conditions which may manifest as mild     to moderate cognitive impairment and, in late phase, dementia. This study also intends to     investigate if the responses to rTMS intervention are either positively or negatively     correlated with the initial severity of cognitive impairment.   "
50742|NCT02621411|"     Substance abuse is a growing problem world wide, and treatment of substance abusers in the     perioperative period, especially for emergency operation is challenging. The objectives of     this study are to determine the proportions of substance abusers in the trauma patients     undergoing emergency operation by preoperative screen, observe the differences of consumption     of anesthetics and other medications during perioperative period between substance abusers     and non-abusers, as well as postoperative complications, and explore an optimal scheme for     substance abusers.   "
50743|NCT02621398|"     This phase I trial studies the side effects, best dose, and best way to give pembrolizumab     when given together with paclitaxel, carboplatin, and radiation therapy in treating patients     with stage II-IIIB non-small cell lung cancer. Monoclonal antibodies, such as pembrolizumab,     may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Giving pembrolizumab together with paclitaxel, carboplatin, and radiation therapy may kill     more tumor cells.   "
50744|NCT02621385|"     This study is designed to evaluate the potential effect of administration of tradipitant on     CYP3A4 using midazolam pharmacokinetics as markers.      The study will also further characterize the pharmacokinetics of tradipitant.   "
50745|NCT02621372|"     Portal hypertension is a common complication of liver cirrhosis that can lead to development     of esophageal varices (EV). They are abnormally dilated veins within the wall of the     esophagus that lead to haemorrhage (1). Majority of patients with cirrhosis will develop EV     at some point, and about third of these patients will have at least one bleeding episode     because of rupture of a varix . For this reason, screening endoscopy for detection of the     presence of EV should be part of the diagnostic work-up in patients with cirrhosis. This is a     very important preventive step for identification of those patients with variceal bleeding     risk and furthermore, identification of patients in urgent need for prophylactic treatment.      All guidelines stress on screening endoscopy for early detection of EV in cirrhotic patients     with portal hypertension. However this approach is limited by its invasiveness and cost     effectiveness issues of screening endoscopy .   "
50746|NCT02621359|"     Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with     peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.      Therefore, the eradication of the pathogen is of critical importance to reduce H.     pylori-related complications .      However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has     become more challenging. With a great decline in the eradication rate of standard triple     therapy for Helicobacter pylori to below 70% in many countries.      Treatment with triple therapy, which is the most frequently recommended, fails to eradicate     H. pylori in approximately 20% of cases .   "
50747|NCT02621346|"     Mental imagery is effective for improving motor skills as well as increasing muscles strength     and size. Strength is also maintained after immobilization of a muscles when engaging in     imagery. This may have important implications for rehabilitation settings and for sedentary     individuals. We may not be able to get people wot exercise but if they can maintain muscles     size and strength via imagery this may have beneficial health and functional outcomes.   "
50748|NCT02621333|"     This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy     of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung     adenocarcinoma.   "
50749|NCT02621320|"     There is a high prevalence of vitamin D deficiency in Switzerland. In indoor-athletes as well     as wheelchair users, vitamin D deficiency occurs even more often. It is well established that     vitamin D deficiency has a negative effect on health. However, vitamin D supplementation in     individuals with a vitamin D deficiency has a positive effect on muscle performance. In     recently published studies with able-bodied subjects, it has been shown that a normal vitamin     D level (>75nmol/L) can only be achieved with a high-dose supplementation of vitamin D.      The aim of this study is to examine the effect of vitamin D supplementation on exercise     performance in wheelchair athletes with vitamin D deficiency . All participants with a     vitamin D deficiency are assigned to the intervention group and treated with 6000 IU of     vitamin D3 daily over a period of 12 weeks. All participants who have a normal vitamin D     level will receive placebo treatment (control group). The physical performance is measured     three times at baseline, after six weeks and 12 weeks. The measurements include a Wingate and     a dynamometer test.   "
50750|NCT02621307|"     The purpose of this study is to determine whether drinks containing Salvia hispanica L     (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy     individuals.   "
50751|NCT02621294|"     Our objective is to determine the dietary requirement of protein for strength and endurance     exercise trained (more than 4 months training experience) individuals between 18 - 30 years     of age using the indicator amino acid oxidation (IAO) method. This study will be the first to     determine the required quantity of protein need per day in strength- and endurance trained     young adults using the IAO method.   "
50752|NCT02621281|"     This is a multi-centers prospective, randomized, controlled trial. This trial will     investigate the clinical outcome of kidney transplant recipients whose kidneys are under two     different forms of organ preservation--hypothermic machine perfusion vs. static cold storage.     Factors during the machine perfusion, such as the pressure, flow rate, and resistance index     will also be investigated.   "
50753|NCT02621268|"     Determine if ICG administered pre-operatively, then imaged intraoperatively using our     cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes     and satellite nodules during minimally invasive procedures. The investigators intend on     enrolling 48 Subjects in this study. The study is focusing on patients presenting with     suspected thoracic cancers who are considered to be good minimally invasive surgical     candidates   "
50754|NCT02621255|"     Investigator' s study designed to investigate effect of general and regional anesthesia on     fracture healing.The 40 age and older ASAI-III patients who will operate due to femur     fracture (except femur neck fracture) will be enrolled in this study after informed consent     approval.      Subjects will be divided into two groups by a computerized randomization method. 40 patients     will be enrolled in this study. General anesthesia will perform for 20 patients. Regional     anesthesia will perform for 20 patients. Preoperative, 4. week and 12. weeks laboratory test     which include blood and urine β-C terminal telopeptid (β-CTX), blood alkaline phosphatase and     osteocalcin will test for all patients. All patients will not use nonsteroid     anti-inflammatory drugs during study neither perioperative nor postoperative periods.     fracture healing will be asses with clinical evaluation and laboratory tests.   "
50755|NCT02621242|"     As explained in detail in a recently published hypothesis article (Hladik F. A new hypothesis     on HIV cure. F1000Research, 4:77 (2015)), the investigators hypothesize that NRTI drugs may     reduce the likelihood of HIV eradication by promoting the survival of cells with integrated     provirus. In this study, the investigators will test whether daily oral use of two NTRI     drugs, tenofovir and emtricitabine (Truvada Pill), induces changes in the upper and lower gut     mucosa that are congruent with supporting this hypothesis.   "
50756|NCT02621229|"     The purpose of this multi-center randomized controlled trial is to compare lower calorie     refeeding to higher calorie refeeding for hospitalized adolescents and young adults with AN.     The investigators will compare efficacy (achievement and maintenance of clinical remission at     12 months), safety during hospitalization, and cost effectiveness (including costs of initial     and re hospitalization, 12 month follow up and safety/adverse events).   "
51912|NCT02606084|"     The purpose of this study is to evaluate the pharmacokinetics of a single dose of     intranasally administered esketamine in participants with impaired renal function when     compared to participants with normal renal function.   "
50757|NCT02621216|"     Background of the study:      Percutaneous coronary interventions (PCI) have become mainstay treatment for acute coronary     artery disease and the number of patients receiving PCI is vastly growing. However,     relatively little long-term follow-up studies of large real-world clinical samples exist that     have looked at the real-world effects of PCI treatment and adherence to current guidelines.      Psychological risk factors are important in determining prognosis after PCI, and undergoing     PCI may increase the risk of low mood. To date, studies have examined single psychological     risk factors, without taking into account their relatedness. Moreover, guidelines are     advocating psychosocial screening in early cardiovascular disease, but the screening test as     proposed in the prevention guideline has not yet been validated or tested. Although the     detrimental effects of psychological risk factors on cardiovascular prognosis are known, the     mechanisms through which they exert these effects are yet unclear. It is to be expected that     not one but multiple biological (inflammation, endothelial dysfunction) and behavioural     (coping styles, poor self-care, consultation behaviour) pathophysiological processes play a     role, and that these processes interact with each other. In PCI patients the mechanisms     linking psychological risk to poor prognosis are still to be investigated.      Objective of the study:        1. To examine the adherence to the prevention and PCI guidelines and the effects thereof on          long term prognosis in PCI patients.        2. To evaluate the effectiveness of the psychosocial screening instrument of the European          Society of Cardiology Prevention guideline 2012.        3. To examine effects of clustering psychological risk factors on several networks of          potentially mediating mechanisms and long term outcomes in a large sample of PCI          patients.   "
50758|NCT02621203|"     A multicentre, prospective, observational, hospital-based registry of patients with acute     heart failure (AHF) those whose care was guided by a cardiologist in Turkey.   "
50759|NCT02621190|"     After failure on docetaxel, which has been the standard first line therapy for patients with     metastatic castration-resistant prostate cancer (mCRPC), several treatment options are     currently available. In retrospective studies, resistance has been described to two of the     treatment options, enzalutamide and abiraterone, when a splice variant of the Androgen     Receptor (AR-V7) is present on circulating tumor cells (CTCs). The investigators hypothesize     that patients with AR-V7 positive CTCs do have a meaningful response to cabazitaxel.   "
50760|NCT02621177|"     This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of     the study is to describe the immunogenicity and safety of the trivalent cell culture-derived     influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.   "
50761|NCT02621164|"     This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of     the study is to describe the immunogenicity and safety of the quadrivalent cell     culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine     among subjects.   "
50762|NCT02621151|"     This trial is to assess the efficacy of pembrolizumab (MK3475) added to concurrent radiation     and gemcitabine in the management of patients with muscle-invasive urothelial cancer who are     not candidates for or decline radical cystectomy.   "
50763|NCT02621138|"     Population:      16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age.      All children aged 6-12 yrs who understand simple commands.      Tools:        1. Polar monitor to record heart rate, attached to chest, in use throughout testing        2. Dynamometer- for assessing muscle strength.        3. Weights      Method:      Each child will be tested once. Both tools will be demonstrated and tried out before actual     testing.      With Polar watch attached:        1. 5 min sitting at rest,        2. knee muscle strength assessment with the dynamometer,        3. 15 minutes rest        4. Isometric and isotonic knee muscle contraction at 30% of childs` maximal strength as has          assessed by the dynamometer. The child will asked to perform each for 3 minutes, with 5          minutes rest in-between All will be perform in both legs.   "
50764|NCT02621125|"     This is a double blind, randomized, placebo controlled clinical trial to test the efficacy of     the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men     diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)   "
50765|NCT02621112|"     Hepatitis B virus infection remains an important clinical issue among patients on renal     replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer > 10 IU/L after     intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Factors associated     with inadequate anti-HBs response include older age, diabetes mellitus, obesity and low     hepatitis B vaccine dose. Various small-scale studies including multiple high dose     intramuscular vaccination or multiple small dose intradermal vaccination were attempted with     variable response. Recent study on dose sparing seasonal influenza vaccine delivered via a     novel intradermal microneedle has demonstrated good immunogenic responses similar to     full-dose intramuscular vaccination. Imiquimod, a synthetic TLR7 agonist useful for the     treatment of DNA virus infection, has been shown to improve vaccine immunogenicity. The     investigators therefore propose a prospective, randomized study to compare the safety and     immunogenicity of intradermal hepatitis B vaccination with this novel device with     intramuscular in patients on renal replacement therapy.   "
50766|NCT02621099|"     A novel hand held hybrid optical-gamma camera (hereinafter referred to as the camera) has     been developed and can be used to image radiotracer distribution at the patient bedside. This     study aims to evaluate the imaging capabilities of the camera in patients attending surgery     for sentinel lymph node biopsy (SLNB) procedure. It is anticipated that this could improve     the accuracy and simplify sentinel lymph node detection by providing fused optical and gamma     imaging.   "
50767|NCT02621086|"     This is an initial pilot study to assess and investigate if any adverse symptoms occur (and     also the severity of any symptoms) after consuming a food-grade Cellodextrin preparation.     Volunteers will attend a short (around 30mins) medical screening visit, to make sure they are     suitable to take part in the study. They will then attend 4 study visits (separated by at     least a week) for around 9.5 hours each time. During the study visits 10, 20, 30, or 50g of     Cellodextrin will be given as a single oral dose, in a milkshake drink, and any symptoms     experienced will then be monitored via questionnaires during the study day and for the next     60 hrs, dietary intake will also be measured over this time.   "
50768|NCT02621073|"     To answer the question: Do Prontosan instillations decrease time to wound and fracture     healing and decrease bacterial load compared to wound vac treatment without Prontosan?, we     will enroll up to 30 subjects (for an anticipated 20 complete data sets) into this trial. The     subjects will be split equally into two different groups by randomization. One groups will     have wound vac therapy with Prontosan, and one group will have wound vac therapy without     Prontosan. Data related to wound and fracture healing and bacterial load will be assessed     between the two groups to determine if wound vac therapy with Prontosan speeds up healing     time and decreases bacterial load.   "
57636|NCT02531126|"     The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients     diagnosed with moderate to severe ulcerative colitis.   "
50784|NCT02620865|"     This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed     activated T-cells when given together with aldesleukin and sargramostim and to see how well     they work in treating patients with pancreatic cancer that has spread from where it started     to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic).     Bispecific antibody armed activated T-cells are the patient's own T cells that are coated     with a bispecific antibody comprising 2 antibodies chemically joined together. These     antibodies have specific targets and binding properties that may give the T cells a greater     ability to seek out, attach to, and kill more cancer cells.   "
50846|NCT02620059|"     The aim of this study is to examine the impact of lifestyle intervention on postpartum weight     loss. So the investigators will have two groups in this study. In Experimental group women     will receive the Healthy Lifestyle Intervention. This intervention will have been delivered     during 12 weeks. In Control group women will receive general information via pamphlet about     postpartum period and tips for stress management.   "
50847|NCT02620046|"     The purpose of this study is to obtain long term safety and tolerability data of vedolizumab     subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's     disease (CD).   "
50772|NCT02621021|"     Background:      Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes     (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to     the person. Researchers think adding the drug pembrolizumab might make the therapy more     effective.      Objective:      To test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma     tumors.      Eligibility:      People ages 18 70 years with metastatic melanoma      Design:      Participants will be screened with:      Physical exam      CT, MRI, or PET scans      X-rays      Heart and lung function tests      Blood and urine tests      Before treatment, participants will have:      A piece of tumor taken from a biopsy or during surgery in order to grow TIL cells      Leukapheresis: Blood flows through a needle in one arm and into a machine that removes white     blood cells.      The rest of the blood returns through a needle in the other arm.      An IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if     assigned)      Participants will stay in the hospital for treatment. This includes:      Daily chemotherapy for 1 week      For some participants, pembrolizumab infusion 1 day after chemotherapy      TIL cell infusion 2 4 days after chemotherapy, then aldesleukin infusion every 8 hours for up     to 12 doses      Possible filgrastim injection      Recovery for 1 2 weeks      After treatment, participants will:      Take an antibiotic and antiviral for at least 6 months      If assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have     another round.      Have 2-day follow-up visits every 1 3 months for 1 year and then every 6 months   "
50773|NCT02621008|"     A self administered 16 weeks plus follow up study to explore the efficacy of mobile phone     driven apps for stress reduction coupled with guidance for healthy living among obese and     overweight populations. The Study primary end points are weight of the participants, as well     as glucose measurements (for subject with diabetes) and blood pressure (of subjects with     hypertension).   "
50774|NCT02620995|"     The study will evaluate the effects of a chronic 30-day treatment with sildenafil citrate on     penile and systemic microvascular function as well as in blood pressure.      A control group of normotensive age-matched healthy subjects will serve as a comparator group     for normal penile and systemic microvascular function.   "
50775|NCT02620982|"     This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock     wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of     vasculogenic origin.   "
50776|NCT02620969|"     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases     in childhood resulting in a lifelong need for health care, and a 3 times decreased life     expectancy. In addition, they have important comorbidities that negatively impact on their     quality of life and integration in society, jeopardizing their future even after a potential     transplantation. Retention of uraemic toxins is accepted to play a major role in the     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,     there are currently no good tools to evaluate severity and monitor adequacy of treatment,     resulting in suboptimal management.      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide the     clinician with new diagnostic and therapeutic tools for the management of children with CKD,     based on the improved understanding of uraemic toxicity.      In the first part of UToPaed, the investigators will associate concentrations of a wide     variety of uraemic toxins with different comorbidities in CKD children. In this second part,     a kinetic analysis will be performed to unravel the distribution and transport of the     different studied uraemic toxins in the body of the patient. The toxins of which     concentrations are best correlated with comorbidities during the progress of CKD (UToPaed -     part 1: observational study) and have representative kinetics will be selected as markers.     These markers will be, together with the comorbidities, further tracked after interventions,     i.e. starting on dialysis, transplantation, changes in dialysis strategy (UToPaed - part 3 -     intervention study) in order to validate the different kinetic models.      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations     will be developed to optimise and individualise the dialysis therapy.      By providing clinicians with more advanced and appropriate tools to improve management of all     children with CKD, i.e. better assessment of the degree of renal dysfunction, better     determination of the ideal time to start renal replacement therapy, and more accurate     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and     psychosocial functioning (short term), growth, maturation into puberty, and social     integration (median term) and survival (long term).   "
50777|NCT02620956|"     BACKGROUND: The aim of this study was to assess pulmonary deposition and distribution of     radio-aerosol in obese and normal women, using 2-D planar scintigraphy. METHODS: after     inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA)     with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a     vibrating mesh inhaler.   "
50778|NCT02620943|"     Background: Maternal and child under-nutrition is the underlying cause of death for millions     across the globe. Anemia during pregnancy is among the leading nutritional disorders with     serious short and long term consequences to both the mother and fetus.      Objective: Examine the effect of dietary diversity on maternal anemia, nutritional status and     key pregnancy outcomes of pregnancy.      Methods: A prospective cohort study design, involving a total of 432 eligible pregnant women,     in their second antenatal care visit was conducted between August 2014 to March, 2015. The     individual dietary diversity Score (IDDS) was used as the exposure variable to select, enroll     and follow the mothers. Epi-data, SPSS and STATA software are used to enter and analyze the     data. Chi-square test, independent 't'-test, and GLM are used to calculate risk, association     and differences between key variables at P < 0.05   "
50779|NCT02620930|"     DASAP-HF is an observational prospective single arm study. All patients will be treated     according to the standard care followed by each center. The protocol requires enrollment of     consecutive patients from each center, according to eligibility criteria. All patients must     sign the Patient Informed Consent (PIC) before the enrollment in the study. All patients,     after the enrollment phase, will be followed for 24 months. Approximately every 12 months a     clinical follow-up procedure should be performed in each patient. A sleep study will be done     in all patients at 1 month (or at 3 months) from the enrollment, in order to evaluate the     performance of the algorithm as a diagnostic tool in this population (primary objective).     During the 24 months follow-up period, all Adverse Events occurred in the study population     will be collected (HF hospitalizations, all-cause deaths, ventricular arrhythmias, etc.). At     the end of the 24 months follow-up, the incidence of clinical events will be evaluated as     well as its association with the Respiratory Disturbance Index (RDI) values calculated by     APNEA Scan algorithm (secondary objective).   "
50780|NCT02620917|"     This is an observational, multicenter, cross sectional study, collecting clinical and     metabolic informations about patients treated with CSII in Italy.   "
51588|NCT02610348|"     Primary Objective:      To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a     three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or     Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.   "
50785|NCT02620852|"     Most physicians still use a one-size-fits-all approach to breast screening in which all     women, regardless of their personal history, family history or genetics (except BRCA     carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit     women by detecting cancers early when they are easier to treat, but they are not perfect.     Recent news stories have discussed some of the potential harms: large numbers of positive     results that cause stressful recalls for additional mammograms and biopsies. With the current     screening approach, half of the women who undergo annual screening for ten years will have at     least one false positive biopsy. Potentially more important are cancer diagnoses for growths     that might never come to clinical attention if left alone (called overdiagnosis). This can     lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast     cancers detected today may fall into the category of overdiagnosis.      This proposal compares annual screening with a risk-based breast cancer screening schedule,     based upon each woman's personal risk of breast cancer. The investigators have designed the     study to be inclusive of all, so that even women who might be nervous about being randomly     assigned to receive a particular type of care (a procedure that is typical in clinical     studies) will still be able to participate by choosing the type of care they receive.      For participants in the risk-based screening arm, each woman will receive a personal risk     assessment that includes her family and medical history, breast density measurement and tests     for genes (mutations and variations) linked to the development of breast cancer. Women who     have the highest personal risk of developing breast cancer will receive more frequent     screening, while women with a lower personal risk would receive less frequent screening. No     woman will be screened less than is recommended by the USPSTF breast cancer screening     guidelines.      If this study is successful, women will gain a realistic understanding of their personal risk     of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from     the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe     this study has the potential to transform breast cancer screening in America.   "
50786|NCT02620839|"     This is a Phase Ib dose escalation / expansion study with the combination of alpelisib and     weekly cisplatin. Dose escalation will follow standard 3+3 design. During dose escalation,     two dose levels of weekly cisplatin (30 and 35 mg/m2, respectively) will be evaluated in     combination with escalating doses of alpelisib in parallel. Cohort B (cisplatin 35 mg/m2) at     a given dose level of alpelisib to open only after corresponding A cohort (cisplatin 30     mg/m2) at the same dose level of alpelisib has cleared DLT window. Cohorts A and B may enroll     in parallel (e.g., Cohort 3A may enroll in parallel with Cohort 2B) as shown below in the     dose escalation schema. Intermediate dose levels and alternative dosing schedules may be     investigated per the discretion of Principal Investigator using same 3+3 dose escalation     schema (e.g. cisplatin administered days 1, 8 of 21 day cycle).   "
50787|NCT02620826|"     This prospective study compares the use of indirect pulp therapy and mineral trioxide     aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the     pulp.   "
50788|NCT02620813|"     There are two purposes of this study:        1. First, the investigators want to see what the differences are in de novo sebaceous lipid          production of people with and without acne.        2. Secondly, the investigators want to know what happens to sebaceous gland de novo lipid          production before and after treatment with topical tretinoin and oral isotretinoin.   "
50789|NCT02620800|"     The purpose of this study is to learn about the safety and potential benefit of metronomic     5-fluorouracil in combination with nab®1-paclitaxel, bevacizumab, leucovorin, and oxaliplatin     in treating patients with metastatic pancreatic adenocarcinoma.   "
50790|NCT02620787|"     This study will determine the tissue penetration of tedizolid (Sivextro, Merck & Co.), a     novel oxazolidinone antibiotic, into the extracellular, interstitial fluid of soft tissue in     diabetic patients with lower limb wound infections. Penetration will be compared with a group     of healthy volunteer control participants.   "
50791|NCT02620774|"     This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck &     Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular,     interstitial fluid of soft tissue in diabetic patients with lower limb wound infections.     Penetration will be compared with a group of healthy volunteer control participants.   "
50792|NCT02620761|"     The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial     with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon     a difference in serum creatinine by one standard deviation. Fluid and salt intake will be     held constant within clinical parameters and carefully measured. Fenoldopam will be started     at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in blood pressure, the dose will be     increased to 0.2 ug/kg/min. This dose will be continued throughout the remainder of the     study. A study of pediatric patients previously provided to the FDA showed no hypotension at     a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of     indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin. Study samples will     include both blood and urine. The primary outcome will be a reduction in renal dysfunction,     as determined by creatinine and urine output over the course of treatment. Additional     outcomes will include determination of known and novel metabolomic urine markers of renal     dysfunction.   "
50793|NCT02620748|"     The purpose of this study is to determine the effect of the early administration of     intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured     intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb),     and frequency of blood transfusions) in women undergoing a myomectomy.   "
50802|NCT02620631|"     This is a prospective, randomized, double-blinded, placebo-controlled study designed to     examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing     total knee arthroplasty (TKA) under spinal anesthesia in addition to a femoral nerve     catheter. The protocol consists of two parts: (1) a prospective patient recruitment study and     (2) a retrospective assay for endocannabinoids on previously collected specimens.   "
50859|NCT02619890|"     This registry aims to collect clinical and radiologic information including detailed     clinical, conventional MR and advanced MR imaging data of patients with brain gliomas.     Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging     (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and     chemical exchange saturation transfer (CEST) imaging. This registry will describe course of     disease and long-term outcomes of brain gliomas.   "
50833|NCT02620228|"     This clinical device investigation is conducted by performing liver biopsies using the BIP -     Biopsy Tool. The aim is to assess the feasibility of bioimpedance spectroscopy based biopsy     tool guidance method and test how well BIP biopsy system is able to distinguish liver tumours     from surrounding tissue. In addition, user feedback is obtained to improve the usability of     the investigational device. The study does not affect the traditional treatment procedure and     only the patients in clinical need for diagnosis by liver biopsy are included on voluntary     basis. The invasive products used in actual biopsy operation are designed so that their     performance is essentially equal to the currently used biopsy devices, the only difference is     the measurement capability of biopsy needle and connection to measurement device.   "
50794|NCT02620735|"     While physical activity (PA) appears to play an important role in disease control and the     promotion of long-term health and well-being of cancer survivors, the large majority of     breast cancer survivors are not physically active. Addressing this problem requires exercise     promotion and an additional method of supporting long term exercise adherence. In response,     an innovative health coaching intervention which uses mobile technology (iMOVE) to promote     long-term PA in breast cancer survivors (BrCa) was developed. Project description: 107     inactive BrCa survivors will be randomized to receive a 12-week exercise program (CONTROL) OR     a 12 week exercise program plus a concurrent health coaching program (iMOVE) consisting of     telephone-based coaching sessions and interactive software delivered through a smart-phone     and Fit-bit (wearable fitness technology) (INTERVENTION). Information on the feasibility and     acceptability of the methods and intervention and examine the impact on fitness (primary),     patient-reported, anthropometric, and physical (secondary) outcomes will be collected. Impact     and relevance: PA has increasingly been identified as a modifiable factor that has the     potential to impact cancer outcomes and improve quality of life. iMOVE is an innovative     intervention with the potential to promote and maintain physical activity for breast cancer     survivors. This study will be the first step in the evaluation of iMOVE and will help to     determine whether a larger randomized controlled trial is needed.   "
50795|NCT02620722|"     This study evaluates a novel technique for measuring the minimum pressure necessary to     achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP).     Patients will have tourniquets applied to their arms and legs and LOP will be measured using     the new technique and a gold standard Doppler ultrasound technique.   "
50796|NCT02620709|"     This project is a community-engaged, randomized control trial of hula, the indigenous dance     form of Native Hawaiians (NH), among 250 NHs with hypertension living in Hawaii and     Washington State. Investigators will compare the effects of a 6-month intervention, called     the KaHOLO Program, delivered by trained peer educators to a wait-list control condition on     blood pressure and 10-year cardiovascular risk. The intervention will be comprised of hula     plus hypertension self-care education program. Investigators will also examine the mediating     effects of health behaviors, self-regulation, psychosocial, and socio-cultural factors on     blood pressure reduction. The ultimate goal is to develop and test a culturally-appropriate,     acceptable, and effective intervention that can be delivered and sustained in community     settings.   "
50797|NCT02620696|"     Hypergastrinaemia induced by proton pump inhibitor (PPI) treatment is reported to cause     ECL-cell and parietal-cell hyperplasia, and rebound hyperacidity and dyspepsia after PPI     withdrawal.      The objective of the study was to determine the dosage regimen of netazepide, a gastrin/CCK2     receptor antagonist, required to inhibit the trophic effects of PPI-induced     hypergastrinaemia.      Six groups of 8 healthy subjects participated in a randomised, double-blind,     placebo-controlled exploratory study of esomeprazole 40 mg daily for 28 days, and netazepide     1, 5 or 25 mg, or placebo daily during the last 14 days of esomeprazole dosing, or 14 days     after esomeprazole withdrawal. Serum gastrin and plasma chromogranin A (CgA) were measured     regularly from study start until at least 1 week after the last dose. Dyspepsia was monitored     after esomeprazole withdrawal.   "
50798|NCT02620683|"     Anecdotal reports suggest buffering lidocaine with epinephrine just before intraoral     injection reduces time of onset, results in a deeper anesthetic effect, without the sting     with injection from a low pH. Additional data are needed to establish clinical important     outcomes such as the peak blood level of lidocaine as compared to the non-buffered drug     combination.      Clinical pilot studies are proposed as the start of a series of investigations to support or     modify the use of the buffered anesthetic for intraoral procedures.   "
50799|NCT02620670|"     Obesity is a major public health problem on the world and Mexico too, in addition the obesity     develops chronic non-communicable diseases (NCD) such as type 2 diabetes mellitus (T2DM) and     cardiovascular disease (CVD). So the phenomenon of obesity is studied in many investigations     to know their causes, prevention and treatment.      Participation of body fat and especially in the visceral area is well documented in the     appearance of T2DM; however, it is quite interesting that found that not all individuals with     visceral obesity have impaired glucose tolerance, prediabetes or T2DM; but they are presented     as normoglycemic individuals with obesity.      Currently, it is recognized that physical activity influences the concentrations of plasma     glucose, and promoting their utilization in peripheral tissues, to be used as an energy     source, through the regulation of glucose transporters in tissues such as the muscle, so     might influence the glycemic variability, and therefore is of interest to this study to     evaluate the effect of physical activity of moderate intensity on the glycemic variability of     individuals with visceral obesity and normal weight without alterations in tolerance glucose.   "
50800|NCT02620657|"     Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will     be recruited by 30 sites in North China.   "
50801|NCT02620644|"     Neuroretinal damage in diabetes produces functional abnormalities such as the loss of     chromatic discrimination,contrast sensitivity and dark adaptation. These alterations can be     detected by means of electrophysiological studies in diabetic patients with diabetes duration     of less than two years, i.e. before microvascular lesions can be detected in ophthalmologic     examination. Neurodegeneration seems to be a generalized process that occurs throughout the     macula and is not confined to local abnormalities, in the cases with visible signs of     retinopathy.      The debate is still open as to whether diabetic retinal neuropathy is the effect of vascular     diabetic retinopathy or is primarily caused by direct neurologic damage from chronic     hyperglycemia. The hypothesis that diabetes causes retinal neuro-pathy independent of     retinopathy is intriguing and potentially links retinal neuropathy to other diabetic     neuropathies.      Neuroretinal degeneration initiates and/or activates several metabolic and signalling     pathways which participates in the microangiopathic process as well as in the disruption of     the blood-retinal barrier which is a crucial element in the pathogenesis of diabetic     retinopathy.      Retinal ganglion cells are the earliest cells affected and have the highest rate of     apoptosis. However, an elevated rate of apoptosis has been also observed in the outer nuclear     layer (photoreceptors) and in the retinal pigment epithelium (RPE). The use of spectral     domain OCT (SD-OCT) makes it possible to measure the thickness of individual layers at higher     resolution and indicates that the thinning of the inner retina in the macula is primarily due     to loss of ganglion cells.   "
50803|NCT02620618|"     Intravitreal injection of up to 2 mg of infliximab has proved to be safe in animal models     (rabbits and primates). These studies have shown no evidence of intraocular inflammation or     toxicity by clinical, electrophysiological, and histopathological examination for up to 90     days even with 3 repeated monthly injections. However, the study conducted by Rassi et al was     the only one to report the development of severe intraocular inflammation in one eye out of     12 rabbit eyes at 90 days following 3 intravitreal injections (2mg monthly). Unfortunately,     clinical studies conducted on patients, so far, have raised serious concern about its safety     and adverse effects.      These clinical studies have shown various and inconsistent results in terms of the safety and     efficacy of intravitreal infliximab. These studies were conducted on patients with refractory     as well as naïve cases of age related macular degenerations choroidal neovascularization (AMD     CNV), diabetic macular edema (DME), central retinal vein occlusion (CRVO), angiomatous     malformations, pseudophakic macular edema, and uveitis. The doses used ranged from 0.5mg to     2mg. The initial study by Theodossaidis et al in 2009 did not report any intraocular     inflammation in 3 patients receiving 2 intravitreal injections of 1 and 2 mg for refractory     AMD CNV with 7 months follow up period.(8) Later several clinical studies have reported     severe intraocular inflammation following intravitreal injections of infliximab in     non-uveitic patients.These collected data have initiated a call for cautious use of     intravitreal infliximab.      On the other hand, studies investigating intravitreal infliximab in uveitis patients have     shown improvement in vision, reduction in macular thickness on optical coherence tomography     (OCT), and reduction in inflammation. In this study, we have investigated the safety and     efficacy of 3 consecutive intravitreal infliximab injections (1 mg/0.05 mL, 6 weeks apart) in     carefully selected group of patients with refractory uveitis in Behcet's disease.   "
50804|NCT02620605|"     Study the effect of early cabergoline administration in prevention of occurrence or     decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And     its effect on oocyte maturation,fertilization and pregnancy rate..   "
50805|NCT02620592|"     This First in Human (FIH) Phase I study intends to evaluate the safety, tolerability,     pharmacokinetics and pharmacodynamics of ZYDPLA1 in normal healthy adult volunteers.   "
50806|NCT02620579|"     Chronic shoulder pain is a common, costly, and disabling problem for society. The     identification of factors predictive of the development of chronic shoulder pain is necessary     to develop innovative and effective treatments to reduce the societal impact of shoulder     disorders. In previous work the investigators identified a genetic and psychological subgroup     that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor     12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study     the investigator proposes to test how interventions tailored to the high risk subgroup affect     pain responses in a pre-clinical cohort.      The optimal theorized match for the identified high-risk subgroup is a combination of     personalized pharmaceutical and education interventions. This combined personalized     intervention versus a placebo pharmaceutical and general education intervention group is the     primary comparison of interest. Also, an evaluation of the individual effect of personalized     pharmaceutical and educational interventions will be part of the study. Such comparisons will     provide important information on what the active portion of the combined personalized     intervention may be.   "
50807|NCT02620566|"     To our knowledge there is still no study comparing the local wound infiltration by itself     without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this     study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal     hernia repair with caudal block (CB) or local wound infiltration (LWI).   "
50808|NCT02620553|"     A dose with proven drug bioavailability to the immune system for use in a phase II/III     primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk     subjects.      Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose     escalation primary intervention pilot study.      Accrual Objective 25 (3:2 randomization to active and control arms)   "
50809|NCT02620540|"     The purpose of this prospective single center study is to investigate if a developed     algorithm is more accurate than the Broselow Tape (BT). For this study 500 patients are     required to collect anonymized data (length, weight, age, anaesthesia material used during     anaesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis     ist that the algorithm has a better accuracy than the BT.   "
50810|NCT02620527|"     Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic     alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA     (ctDNA) within different solid tumor types and has been developing an assay in order to do     so.   "
50811|NCT02620514|"     The purpose of this is to formally assess health literacy and medication adherence in     participants with Inflammatory bowel disease (IBD). The study also aims to improve medication     adherence, health-related quality of life, and disease activity through a 24-week     intervention.   "
50812|NCT02620501|"     Patients will be randomized to a placebo or study group who will receive topical lidocaine     prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will     then be assessed.   "
50813|NCT02620488|"     This pilot study will assess the effects of a brief laboratory-based guided imagery procedure     on responses to pain in patients with sickle cell disease (SCD) and healthy controls.   "
50814|NCT02620475|"     The purpose of this study is to evaluate the effect SutureSafe dressings have on reducing     scarring from an incision following an elective abdominoplasty (tummy tuck) procedure. The     scar will be evaluated using subjective clinical assessment criteria. Each participant in the     study will serve as a control and experiential study, since have of the incision will be     treated with the gold standard of care and the other half with SutureSafe dressings.   "
50815|NCT02620462|"     Knee osteoarthritis (KOA) is one of the leading causes of lower limb disability among the     elderly and can cause loss of knee joint proprioception that contributes towards     deterioration of postural balance. Maintaining a good postural stability is essential while     performing everyday functional activities and to avoid falls. Exercise training has been     reported to reduce pain as well as improve performance of functional tasks in patients with     KOA however compliance to exercise can be challenging due to pain, lack of motivation and     traditional nature of exercise that can easily overtax patients. Furthermore, there are not     exercise programs that are specifically designed for patients with KOA in order to address     lost knee joint proprioception. Recent studies have also demonstrated that visual feedback     during exercise can enhance the benefits of exercise training. Therefore, the aim of the     proposed study is to implement an interactive sensor-based exercise training to improve     postural balance, gait and activities of daily living in patients with KOA.   "
50816|NCT02620449|"     The purpose of the study is to learn more about how common food additives can affect     phosphorus metabolism in people with normal kidney function and people with chronic kidney     disease.   "
50817|NCT02620436|"     Objectives: The primary objective of this evaluation is to determine if well-constructed and     well-resourced Maternity Waiting Homes are utilized by pregnant women living at distance from     the health facility and are associated with improved pregnancy outcomes, particularly for     women living farthest from health facilities. Findings from this evaluation will be provided     to policymakers formulating policy decisions affecting the implementation of the Maternity     Home Model and, if applicable, will be used as evidence for programmatic decisions made by     the Ministry in deciding to take this model to scale beyond the districts proposed for this     project.      Primary Impact Evaluation Question: Does the Minimum Core Maternity Home Model increase     access to high quality intrapartum care among mothers living more than 10 km from the     facilities compared to the standard of care?      Study Design: We propose a quasi-experimental pre-post design wherein one implementing     partner (BU/ZCAHRD) will use a cluster-randomized matched pair design and one implementing     partner (University of Michigan/Africare) will utilize a matched-pair, two-group comparison     design with no randomization.      Methods: Using mixed-methods, we will collect data from two main sources: 1) Household     Surveys and 2) In-depth Interviews. A quantitative household survey will be conducted among     2,400 randomly-selected households at both baseline (2015) and endline (2018) among recently     delivered women (delivered in the last 12 months) living more than 10 km from the     intervention and comparison facilities.      15% of the households enrolled in the study will be randomly selected to participate in an     In-Depth Interview (IDI). Content will include perceptions of labor and delivery practices,     barriers to accessing care, knowledge and awareness of MSs, perceptions of the quality of MS,     perceptions of respectful care at the facility, post-natal care, costs, and perceptions of MS     ownership.   "
50818|NCT02620423|"     The purpose of this Phase 1b study is to investigate whether intravenous administration of     REOLYSIN® in combination with chemotherapy and pembrolizumab is effective and safe in the     treatment of pancreatic adenocarcinoma.   "
50819|NCT02620410|"     The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral     Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm     the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment     of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and     quality of life data.   "
50820|NCT02620397|"     This trial is designed as a prospective, multi-center, observational study of all-comers     eligible adult subjects presenting to participating emergency departments with symptoms     suggestive of acute coronary syndrome (ACS)   "
50821|NCT02620384|"     The primary objective of the study is to determine efficacy of metolazone as synergistic     therapy with Lasix in patients with acute decompensated heart failure. This will be a single     center double blinded randomized placebo- controlled pilot study of the addition of 5 mg of     metolazone per day for 2 days compared to placebo in patients admitted with acute     decompensated heart failure.   "
50822|NCT02620371|"     This study aims to compare the analgesic efficacy and safety of local bupivacaine alone     versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients     undergoing breast cancer surgery.   "
50823|NCT02620358|"     This study compares two opposite strategies of weaning from Mechanical Ventilation. One of     them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2     hours. The aim of the study is to know witch one has a higher successful extubation rate.   "
50824|NCT02620345|"     Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and     women pregnancy to lost the size fibroids.   "
50825|NCT02620332|"     Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the     pancreas are destroyed such that the patient is reliant on injection of insulin to adequately     control blood glucose levels for the remainder of his/her life. The autoimmune process     targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a     novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and     tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is     a mixture of peptides from islet auto antigens. The mixture has been designed to induce or     restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to     protect beta-cells   "
50826|NCT02620319|"     The objective of this project is to determine whether biodegradable polydioxanone stents are     efficient in the treatment of adult patients with tracheobronchial stenoses.   "
50827|NCT02620306|"     The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients     with hypertensive diabetic chronic kidney disease.   "
50828|NCT02620293|"     This is an open label, non-comparative investigation to determine the tolerance of Eczema     Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin.      The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance will     be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.   "
50829|NCT02620280|"     This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and     nab-paclitaxel in patients with locally advanced triple negative breast cancer. compared to     the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in     combination with carboplatin and abraxane, while the other half will receive only carboplatin     and abraxane.   "
50830|NCT02620267|"     Individuals with schizophrenia have difficulties in functioning in the community. No one     really knows what factors determine how well patients manage in the real world. The purpose     of this pilot study is to try a new approach to improving a potential determinant of good     community functioning, namely how we process sounds. Specifically, we propose to examine the     benefit of transcranial direct current stimulation (tDCS), a new tool that is being developed     as a safe and non-invasive neurostimulation method, for improving processing of sounds.     Transcranial direct current stimulation involves placing a wet sponge electrode on the head     and one on the arm. Electrical current from a device powered by a 9-volt battery will flow     from one electrode to the other. A small portion of the current will pass through the skull     and stimulate the brain. This procedure is non-invasive and painless and it results in     increase or decrease of spontaneous neuronal firing in the brain. Neurons are brain cells     that send electrochemical messages to each other. Its safety and beneficial effect on mental     functions has been demonstrated in healthy individuals and several clinical populations.      The purpose of this study is to determine if transcranial direct current stimulation can     effect how we process sounds.   "
50831|NCT02620254|"     The Mast Cell Connect Registry is a voluntary, observational database that will capture     demographic, socioeconomic, and disease information directly from patients with mastocytosis     via a secure web-based tool. No experimental intervention is involved.   "
50832|NCT02620241|"     The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a     stable upright position during 20 min. This is an addendum to the previous study with record     number clinical trials.gov NCT02124863   "
50834|NCT02620215|"     About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a     lengthy process especially when cervical priming is required. Although mechanical method of     induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic     reviews comparing mechanical method against pharmacological and surgical IOL showed that     mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric     procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled     trial concluded that both cervical ripening balloon and prostaglandin are effective and     complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined     the effects of pain.      The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st     prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test     the acceptability of women in Singapore in using the CRB as an alternative method of     induction of labour while using a non-incremental balloon filling regime. Currently, there is     no efficient method of induction that can be used safely in an outpatient setting. Through     this study, the investigators hope to show that there are no major adverse events in the 12h     after patients are induced with CRB, this potentially supports outpatient IOL with CRB which     can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will     decrease time delays and may increase patient satisfaction during its use in induction of     labour.   "
50835|NCT02620202|"     The main aim of the WESTCOR study is to        -  investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to          diagnose acute coronary syndrome and predict prognosis in different patient populations          (e.g. gender, age and co-morbidity)        -  to validate the suggested 1 hour protocol for rule in and rule out of acute coronary          syndrome for two hs-cTn assays in an unselected chest pain population        -  to investigate different biomarkers ability to predict long term prognosis after          hospitalization for chest pain   "
50836|NCT02620189|"     Preliminary data suggest that up-regulation of Interleukin -17 (IL-17) and the T-helper 17     (Th17) pathway occurs in rheumatoid arthritis (RA) patients on anti-Tumour Necrosis Factor     (TNF) therapy who demonstrated an incomplete clinical response. A deeper understanding of     this is required in order to determine whether IL-17 or the Th17 pathway is a valid target     for intervention in this population to improve response outcome.      The study objective is to observe biologic naïve RA subjects on anti-TNF therapies and take     measurements of peripheral blood and synovial tissue to assess differences in the IL-17 and     Th17 pathways between responders and non-responders. The aim of the study is to test if     increased Th17 pathway activity is present in subjects who do not respond clinically to     anti-TNF therapy.      Clinical assessments, synovial bio-markers and ultrasound will be used as determinants of     clinical response. The study may identify disease characteristics that determine which     subjects may be more likely to respond to anti-TNF therapy, or those who may require either a     different treatment option, or additional pathway inhibition in addition to TNF, in order to     achieve clinical response.   "
50837|NCT02620176|"     We are evaluating the role of transcutaneous electrical vagal nerve stimulation in the     prevention of oesophageal pain hypersensitivity using a validated human model in healthy     volunteers.   "
50838|NCT02620163|"     To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in     patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment   "
50839|NCT02620150|"     This is a 10 week, double-blind, placebo controlled trial to evaluate SSRI (Selective     Serotonin Reuptake Inhibitor) effects for treatment of depression in HIV/AIDS with a focus on     innate immunity and inflammation. Depressed population is HIV + on cART, not currently on     treatment for depression. Subjects will complete cognitive behavior therapy, CCBT for their     depression. Blood samples collected for virologic, neuroendocrine, and immunologic     evaluation. Our overarching hypothesis is that SSRI treatment of depression and improvement     of depressive symptoms leads to increased innate immunity and decreased inflammation,     resulting in better control of HIV disease and decreased morbidity.   "
50840|NCT02620137|"     A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was     performed. Patients were randomized into 2 groups: those patients receiving the multivitamin     supplement during 3 months (Group 1), and those receiving the supplement during 12 months     (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months     after surgery.   "
50841|NCT02620124|"     Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the     outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.      Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue     support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone     levels 14 days after thawing   "
50842|NCT02620111|"     The aim of this study is to investigate potential protein synthesis effects of whey protein     high in leucine compared to whey protein with normal leucin content in elderly patients in a     acute crossover setting. We will use the method of a 2 X 3 h tracer infusing protocol with     15Nphenylalanine along with blood samples and muscle biopsies.   "
50843|NCT02620098|"     The purpose of the study was to examine the effectiveness of an occupational therapy led     handwriting intervention for special education and at-risk kindergarten students.   "
50844|NCT02620085|"     Observe the relationship between thyroid function and personality traits   "
59205|NCT02510599|"     The purpose of this study is to evaluate the effects of solithromycin on hepatic histology     and biomarkers in patients with nonalcoholic steatohepatitis.   "
50845|NCT02620072|"     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta     cells. The process of autoimmune destruction is identified by circulating islet     autoantibodies to beta cell antigens, and is mediated by a lack of immunological     self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or     periphery in a manner that deletes autoreactive effector T cells or induces regulatory T     cells. Immunological tolerance can be achieved by administration of antigen under appropriate     conditions. Evidence is now emerging in humans that these approaches may be effective in     chronic inflammatory diseases such as multiple sclerosis and allergy. Administration of oral     insulin in multiple islet autoantibody-positive children offers the potential for inducing     immunological tolerance to beta cells and thereby protect against further development     progression to type 1 diabetes.   "
50848|NCT02620033|"     The researchers hope to learn if yoga complementary therapy would improve health-related     quality of life, recovery of urinary continence and erectile function in patients who     underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in     patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary     therapy would improve health- related quality of life (HRQOL), recovery of urinary continence     and erectile function.      This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care     group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in patients     who underwent radical prostatectomy (RP). Yoga therapy will be given to the intervention     group three times in a week for 6 weeks prior to surgery and then initiated 3 weeks after the     surgery for another 6 weeks. The yoga exercise will be tailored to the participant's comfort     level. As an exploratory analysis, we will evaluate pro-inflammatory and immunological     markers.   "
50849|NCT02620020|"     The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo     as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI)     Numerical Rating Scale (NRS).      Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to     placebo as measured by:        -  Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score        -  Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score        -  Change from baseline in the average daily LBPI NRS score   "
50850|NCT02620007|"     The primary objective of this trial is to assess whether a 12-week treatment with     Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in     adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or     without involvement of the caecum or the right colon.   "
50851|NCT02619994|"     The purpose of this study is to compare the efficacy of a 'new treatment regimen including     delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months     (investigational arm)' and 'the standard treatment regimen including injectables for 20 to 24     months (control arm)' for treating quinolone sensitive multidrug-resistant tuberculosis.   "
50852|NCT02619981|"     150 children aged between five and seven years presenting for the first dental visit, whose     parents consented to participate in the study were selected from patients reporting to the     dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse     rate for each patient was measured at different clinical situation starting from patient     parent separation until end of appointment using a pulse oximeter, Data which collected was     statistically analyzed using appropriate statistical analyses using SPSS ver.19 data     processing software.   "
50853|NCT02619968|"     The aim of this study is to analyze the effectiveness of physical exercise with blood flow     restriction on the diameter and the flow of vessels, muscle strength and circumference of the     forearm in patients with CKD prior to making FAV.   "
50854|NCT02619955|"     The study explores the hepcidin deficiency causes of rare iron overload (excluding C282Y     homozygosity), and aim to characterize this iron overload in term of clinical, biological,     genetic and functional spacificities.   "
50855|NCT02619942|"     To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve     disease-free survival in patients with right colon cancer, compared with standard D2 radical     operation.   "
50856|NCT02619929|"     The aim of this non-interventional study is to assess oral vinorelbine dose schedules     (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of     treatment under routine conditions in Germany together with the underlying reasons for the     respective chosen schedules.   "
50857|NCT02619916|"     The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)     and cognitive behavioral therapy (CBT) are effective in reducing depressive symptoms in     patients after cancer   "
50858|NCT02619903|"     Chronic obstructive pulmonary disease (COPD) and gastric ulcer both get infected via or from     the oropharyngeal tissues and have antibiotics in their treatment regimen of both diseases.     This proposal suggests that the oral microbiome, in particularly dental plaque, is a     plausible source of reinfection of COPD and gastric ulcer.      Subjects with COPD or gastric ulcer are randomized to an adjunctive dental cleaning or no     dental treatment. Both groups undergo the regular treatment for their respective diseases.     Both groups have a full dental examination and have salivary microbiota as well as dental     plaque harvested.      The primary outcome variables is COPD exacerbations and new gastric ulcer event, and the     secondary outcome variable re-colonization of the stomach and lung.      Given that the study shows that additional dental cleaning does have an impact on reinfection     of gastric ulcer and COPD it implies that dental cleaning should be subsidized when treating     these diseases. This would have a significant impact on restricting antibiotic resistance as     both H. pylori infections and COPD are treated with antibiotics. Both diseases also cause     personal suffering and consequently disables the person to work, which causes financial     consequences, and of course healthcare expenses.   "
50864|NCT02619825|"     First, investigators must determine the physiological standards across age classes of     myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular     stiffness [VD] and left ventricular [LV]). This will be done in groups of children without     heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1     year-5 years, 5 years-15years]).      Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on     different groups of children (same age group) with cardiomyopathy and examine correlations     with the conventional parameters of systolic and diastolic function of both ventricles and     with myocardial strain values. The total population of the study will be 120 children (40     healthy, 80 patients).   "
50865|NCT02619812|"     For patients who receive a hematopoietic cell transplant (HCT), there is a risk of developing     a diarrhea secondary to the chemotherapy which we give. Diarrhea is usually harmless in     healthy adults; however, in transplant patients, diarrhea can result in dehydration, negative     impact on quality of life, and prolonged hospitalization. The purpose of this study was to     see if Colesevelam (Welchol) and Serum-derived bovine immunoglobulin-protein (SBI) result in     a change in the frequency or consistency of your bowel movements.   "
50866|NCT02619799|"     This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally     administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and     duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and     rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine     via epidural route.   "
50867|NCT02619786|"     The purpose of this study is to determine whether inhaled colistin is effective in the     treatment of ventilator associated tracheobronchitis due to gram negative organism     susceptible to colistin.   "
50868|NCT02619773|"     Infections at the site of surgical incisions (SSIs) are the most common infection among     surgical patients. Although all patients undergoing surgical procedures are at risk for     developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging from     3-45%. These infections can increase the length of hospital stay, and increase the rate of     readmissions and costs.      Further research is needed to study the effects of mupirocin in general surgery. A recent     study compared colorectal SSI rates between mupirocin and standard gauze surgical dressings.     The results of this show that mupirocin has the greatest effect on reducing SSI rate when     compared to standard gauze dressings. However, these studies have not been performed in the     United States and have only been studied on a very specific patient population.      The purpose of this study is to assess the rate of infections at the surgical incision after     colorectal surgery when a mupirocin dressing is placed versus a standard gauze dressing     without mupirocin.   "
50869|NCT02619760|"     The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy     (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent     (CoCr-EES).   "
50870|NCT02619747|"     Multi-centre, randomised, open-label, placebo-controlled, two-period crossover study of 4     hour pH monitoring following a refluxogenic meal and drink.   "
50871|NCT02619734|"     The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow     stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell     disease.   "
50872|NCT02619721|"     Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation     to patients with refractory Overactive Bladder.   "
50873|NCT02619708|"     In the current constantly changing healthcare landscape quality measurement has a central     role. As the practice of medicine is shifting from authority to accountability, the quality     of surgical interventions is under continuous scrutiny by patients, peers, payers, and policy     makers. If done appropriately quality measurement can empower all members of the healthcare     debate. There is increasing focus on patient satisfaction outcomes as quality indicators.      An important part of surgical outcomes is a patient's perception of the result of the     intervention and overall experience in the preoperative setting. When assessing surgical     outcomes, measuring patient satisfaction is necessary. A qualitative systematic review of     patient satisfaction measures noted a scarcity of well-development quality improvement     initiatives to improve patient satisfaction. Anxiety, a potent behavioral and psychological     reaction, weighs heavily on a patient's perioperative experience and is exacerbated by     preoperative concerns about underlying disease and impending anesthesia and surgery.      There are multiple stressors on the day of the surgery: unfamiliar environment, multiple     forms to be signed, and multiple short encounters with new and unfamiliar personnel. These     create confusion, increase baseline anxiety, and can negatively affect patient experience,     and by extension surgical outcomes.      Increasing familiarity with this environment can help patients feel more informed about what     matters most to them, and have more accurate expectations of possible benefits and harms of     their options. This can potentially decrease overall anxiety, improve patient satisfaction,     and decrease pain levels. With the current study investigators will have the following two     specific aims:      Aim 1. To determine whether an immersive preoperative experience (video) is associated with     decreased anxiety and improved patient experience during the perioperative phase.      Aim 2. To determine whether an immersive preoperative experience is associated with decreased     stress, improved patient satisfaction, and decreased pain during the perioperative phase.   "
50874|NCT02619695|"     Mechanical low back pain is one most important emergency department presentations of patients     seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal     anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of     analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse     effects.   "
50875|NCT02619682|"     This phase II trial studies the safety of alternating ixazomib citrate and lenalidomide as     treatment to help keep cancer from coming back after stem cell transplant (maintenance     therapy) in treating patients with multiple myeloma. Ixazomib citrate may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may     stimulate the immune system to attack cancer cells. Giving ixazomib citrate and lenalidomide     as maintenance therapy after transplant may prolong the length of time until the cancer     returns.   "
50887|NCT02619526|"     Heart failure (HF) is a common and disabling condition in the elderly. Randomized clinical     trials and meta-analyses have clearly demonstrated that long-term use of β blockers improves     the outcomes of patients with HF. However, limited data have been available on the treatment     of HF with preserved ejection fraction (EF) in the elderly. No study has specifically     compared the relative effectiveness of carvedilol and nebivolol in treating HF in old age     patients with preserved EF.   "
50888|NCT02619513|"     The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive     analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for     Post-thoracotomy Pain Syndrome(PTPS).   "
51598|NCT02610218|"     To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells     (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in     histologically confirmed HER2 positive advanced/metastatic gastric cancer.   "
50889|NCT02619500|"     The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust     mobilizations for mechanical neck pain when they are applied to both the cervical and     thoracic spine. Both of these techniques have been compared in previous trials but a     pragmatic approach will be employed as well as controlling for clinical equipoise.   "
50890|NCT02619487|"     The purpose of this study is to determine whether a simple text message reminder sent to the     parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in     helping the individual(or parent) become more compliant with self-managing the Type 1     Diabetes (T1D). There will be 5 arms: text message sent to parents of children age 8-12 years     old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with     T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with     T1D,no text message sent to parents of children age 8-12 years, and no text message sent to     adolescents or parents of adolescents age 13-18 years old.   "
50876|NCT02619669|"     Millennium has developed TAK-228, which is a novel, highly selective, orally bioavailable     adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred     to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128 or MLN0128)     targets 2 distinct multiprotein complexes, mTORC1 and mTORC2. TAK-228 selectively and     potently inhibits mTOR kinase (IC50 = 1.1 nM), inhibits mTORC1/2 signaling, and prevents     cellular proliferation.      The mTOR complex (mTORC) is an important therapeutic target that is generally stable (i.e.,     low tendency to mutate) and is a key intracellular point of convergence for a number of     cellular signaling pathways. Inhibiting mTOR may inhibit abnormal cell proliferation, tumor     angiogenesis, and abnormal cellular metabolism, thus providing the rationale for mTOR     inhibitors as potential agents in the treatment of a number of indications including solid     tumor and hematological malignancies, as either monotherapy or in combination with other     chemotherapeutic agents. Like rapamycin, several newly approved rapalogs (temsirolimus and     everolimus) are specific and allosteric inhibitors of mTORC1, and only partially inhibit     mTORC1 signaling pathways. They do not directly inhibit mTORC2, which has shown to be an     emerging target in cancer research. TAK-228 was developed to address the incomplete     inhibition of the mTOR pathway by rapalogs.      Eligible subjects will have a research biopsy and baseline blood and urine studies done     within two weeks prior to start of study treatment. Subjects will then be treated with     TAK-228 for 10 days, and a repeat biopsy and pharmacokinetics will be done on day 11.      The subject will then be treated with the combination of TAK-228 and letrozole for an     additional 110 days, before undergoing resection of the primary tumor. Subjects will be     treated at the recommended Phase II dose of TAK-228 of 3 mg once daily, and a dose     deescalation to 2 mg daily will be performed if dose-limiting toxicity is seen in 1/3 or more     of the subjects at the first dose level. The maximum tolerated dose cohort will be expanded     to include six to ten subjects.   "
50877|NCT02619656|"     The investigators hypothesize that using carbon dioxide for PEG placement versus using room     air will decrease post-procedure pneumoperitoneum as well as improve post-procedure     bloating/pain, and waist circumference.   "
50878|NCT02619643|"     Following brain injury (e.g. stroke), application of non-invasive brain stimulation may     improve rehabilitative efforts. However, the most effective method of non-invasive brain     stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive     brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus     to the head. This method can be applied in a manner that increases (facilitates) or decreases     (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions     within minutes of each other (called primed PAS) may augment changes in excitability more     than a single PAS session alone.      Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS)     to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy     individuals.   "
50879|NCT02619630|"     The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and     maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.   "
50880|NCT02619617|"     The purpose of this study to determine if SOM230 is safe and effective for the treament of     cluster headache.   "
50881|NCT02619604|"     This project addresses the need to improve physician knowledge and clinical practice patterns     related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia     (CLL).   "
50882|NCT02619591|"     Patients with chest trauma undergo ultrasound to detect a collapsed lung. Two techniques have     been described. A single view for each hemi-thorax, and multiple views for each hemithorax.     The investigators are comparing these two techniques in a randomized prospective trial.   "
50883|NCT02619578|"     During the past four decades, gynecologic laparoscopy has evolved from a limited method to an     advanced operative approach that frequently serves as a substitute for laparotomy. The     advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital     stays, and reduced blood loss. However, in the surgery CO2 increases the intra-abdominal and     intrathoracic pressure, which leads to cardiac output decrease and increases sympathetic     activity in a reflex. On the other hand, CO2 accumulation in the body leads to hypercapnia,     which indirectly stimulates aortic body chemosensory organs and carotid sinus, increasing the     concentration of plasma catecholamines, cortisol and vasopressin , these responses have an     important impact on patient recovery after surgery.      Acupuncture is an ancient Chinese method to treat diseases and relieve pain. Transcutaneous     electrical acupoint stimulation (TEAS), a noninvasive adjunctive intervention based on     acupuncture, has been widely accepted and used worldwide. To date, multiple studies have     demonstrated TEAS could reduce intra-operative opioid drugs consumption, reduce the incidence     of postoperative nausea and vomiting (PONV) and improve postoperative cognitive function.     However, whether TEAS could improve the quality of early recovery after gynecologic     laparoscopy is unknown. In this study we therefore investigated the effects of TEAS at the     acupoints of Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) on the     quality of early recovery in the patients undergoing gynecological laparoscopic surgery.   "
50884|NCT02619565|"     This study aims at prospectively enrolling a cohort of 400 incident cases of myelodysplastic     syndromes (MDS) at diagnosis, to evaluate the impact of recurrent mutations on overall     survival and event-free survival, using next generation sequencing. Patients are affected by     ineffective hematopoiesis and a propensity to leukemia in the elderly with a global incidence     of 10/100,000/year.   "
50885|NCT02619552|"     Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal     pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective     medical treatments exist to treat the disease; however they can have significant side     effects.      Previous studies have shown that sexual function is impaired in patients with Crohn's     disease. It is likely that both the symptoms related to the disease, medications used to     treat the disease, and surgery all impair sexual function in a variety of ways. For example,     body image may be impaired, patients may be worried about bowel incontinence or unpleasant     odors associated with diarrhea, patients may have significant pelvic pain secondary to     perianal fistulas, or they may have painful intercourse from adjacent inflammation or     scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual     function is not known.      The investigators propose a 6 month study to compare sexual function before and after     treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug     for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with     steroids.      The investigators anticipate that the investigators will show that therapy with an anti TNF     agent will result in a more rapid and greater return of sexual function than steroids. This     information will be important to help counsel patients about the optimal treatment to begin     for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate     the impact of medical therapy on sexual function.   "
50886|NCT02619539|"     Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without     the need to perform other potentially time consuming investigations.   "
50891|NCT02619474|"     These days, particularly over the last decade, attention is being paid to the opinion of the     patient and, in the case of pediatrics, the patient's family. Unfortunately, recent work has     shown that this remains an imperfect process. Studies of inpatient families show that parents     often leave hospital with only a minimal idea of side effects of drugs, who they can contact     in the event that something goes wrong, and even something as simple as the date of the next     medical visit. In fact, some studies have shown that adult patients don't even know the name     of their doctor or nurse.      While there are several papers examining the degree of unhappiness of parents in hospitals,     there is very little research looking at what can be done to improve a patient's sense of     satisfaction with care (and communication) while in the hospital. One suggestion has been the     provision of whiteboards in the room that can allow the family to have a better idea of what     is going on during the child's day. These have been suggested but never exposed to     prospective, quantitative study.      With the intention of improving the management of patients in the new Acute Care Centre, the     department of strategic planning at Children's Hospital organized a three day IMPROVE session     moderated by PHSA specialists in quality control. During this meeting, the clinical course of     a child on the medical and surgical wards was mapped out. This allowed the group to examine     various ideas aimed at improving the care of children passing through the hospital and the     sense of parental satisfaction with the whole process.      The main conclusion from the meeting (based both on available literature and the clinical     experience of the group), was that communication between the medical team and parents should     be improved. It was also concluded that the best way to do this would be to have a regularly     updated whiteboard in each room. Prior to starting this, it was generally felt that the     introduction of whiteboards should be tested in a prospective controlled manner - starting     with a baseline study of patient satisfaction.   "
50892|NCT02619461|"     This study describes the effect of acute high intensity exercise at 70% VO2peak on     inflammation, stress, appetite hormones and appetite in lean and obese children and     adolescents.   "
50893|NCT02619448|"     The standard treatment for patients with NSCLC (non-small cell lung cancer) and clinically     negative lymph nodes remains surgery per current guidelines. Five year survival for patients     with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of     these patients have heart and lung issues or other diseases which keep them from undergoing     curative surgery. Studies have shown that majority of these patients die from their cancer     and not from their other diseases. This is the reason for treating early stage lung cancer     patients with definitive therapy, when they cannot have surgery. This study will enroll     twelve subjects to evaluate the side effects of this treatment, and decide if it is a good     option for the patients that cannot have surgery.   "
50894|NCT02619435|"     The purpose of this study is to purpose of this study is to assess if regorafenib is active     enough, in terms of 6-month progression-free rate, to warrant further comparative studies in     patients with RAS-mutant advanced colorectal cancer who have progressed after first-line     oxaliplatin-based chemotherapy plus bevacizumab.   "
50895|NCT02619422|"     To determine if an intensive cardiac rehabilitation program with periodic reinforcements     improve the compliance/adherence to secondary preventive measures (physical exercise,     mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary     syndrome with or without ST segment elevation versus an standard cardiac rehabilitation     program   "
50896|NCT02619409|"     Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic procedures.     In some cases the duration of the block is inadequate. An epinephrine wash is sometimes     performed to prolong the duration of the block. The epinephrine wash may prolong the duration     of the block, and if it does, to what extent?   "
50897|NCT02619396|"     Atrial fibrillation (AF) is a very common abnormal heart rhythm, triggered by rapid     electrical activity originating from the pulmonary veins (PVs) that drain blood from the     lungs back to the left atrium (LA). Ablation of the junction between the PVs and the LA,     electrically isolating the veins from the heart, is the key to prevent AF.      When using radiofrequency energy (RF), transmural lesions are required to achieve permanent     pulmonary vein isolation (PVI). New technologies are currently available to predict the     ablation lesion depth and to guide the duration of each application. However, deeper lesions     mean a higher risk of overheating and damage of adjacent structures such as the esophagus     that lies against the back wall of the LA. In order to minimize this risk, the investigators     continuously monitor the temperature inside the esophagus during the procedure through a     probe placed in the esophagus and they promptly terminate energy delivery in case of any     esophageal temperature rises more than 39°C.      To date, it is not known if a low power for a longer time is better than a high power for a     shorter time when ablating on the LA posterior wall in order to create permanent scars     without heating the esophagus.      Therefore, the investigators plan to compare the incidence of esophageal temperature alerts     and the success of the procedure with four different energy settings during ablation on the     LA posterior wall.   "
50898|NCT02619383|"     Recent studies have shown that hyperbaric oxygen therapy (HBOT) can induce angiogenesis and     improve impaired organ function. HBOT was also recently suggested as a possible therapy for     ED due to surgical injuries. However, the effect of HBOT on non-surgical related ED has not     been investigated to date.      The objective in this study was to assess the effect of HBOT on patients with ED by means of     sexual function questionnaires and novel imaging techniques.   "
50899|NCT02619370|"     The overarching goal of this project is to facilitate engagement of individuals in effective     advance care planning (ACP). Our specific objective is to conduct a randomized, controlled     trial to determine whether playing a structured conversation game will increase the     likelihood that participants will complete advance directives and perform other ACP behaviors     compared to those who are provided with only standard ACP educational materials.   "
52735|NCT02595268|"     The purpose of this study is to evaluate the effect of steady-state concentrations of     JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants.   "
50913|NCT02619188|"     This study evaluate the rate of nausea and nutritional status in patients with hyperemesis     gravidarum (severe nausea and vomiting in pregnancy) and healthy pregnant women using a     questionnaire (PUQE-score), self-reported food/drink intake form and blood test. The     Investigators aim for developing normal range of prealbumin measurements (reference values)     during first trimester of pregnancy.   "
50914|NCT02619175|"     aims:        1. To characterize compensatory balance reactions to platform translations during standing          and walking in poststroke individuals in comparison to healthy individuals.        2. To explore the effect of lesion characteristics (location, size) on the patients'          balance reactions.        3. To explore the impact of clinical measures of unilateral sensory motor impairments,          balance, gait and fear of falling on postural reactions in stroke subjects.        4. To examine the effect of a perturbation-based balance training on balance reaction          characteristics in post stroke individuals.   "
50900|NCT02619357|"     The prevalence, low cost, and low burden of wearable devices that provide quantitative and     qualitative feedback on a subject's activity level present an opportunity for the use of     these devices in clinical and observational studies. However, the accuracy and     reproducibility of any given device may vary with device design and algorithm implementation.     Therefore, validation of emerging technologies against known standards such as analysis of     exhaled breath and currently available medical devices is critical. This is a single center,     two-cohort, single period, open-label, methodology study. No investigational product will be     used in this study. Eligible subjects will wear 2 generations of SenseWear Armband devices, 2     ActiGraph GT9x devices (one on the wrist and one on the waist) and a Garmin Vivofit 2     activity tracker wristband for up to 24 hours per day. Subjects who consent to participate in     an optional sub-study will wear a SOMNOwatch Plus EEG-6 device while sleeping. Subjects will     perform a variety of laboratory and field-based exercise tests and strength exercises using     Latex-Free Therabands.The co-primary objectives of this study are firstly to compare the     outputs of the test devices (SenseWear Armband Gecko and Actigraph GT9x) to those of the     SenseWear Armband MF and secondly to assess the sensitivity and accuracy of the test devices     in subjects with COPD or asthma while performing laboratory-based exercise testing.   "
50901|NCT02619344|"     The overall hypotheses of this project is that severe sepsis is associated with endothelial     dysfunction in pediatric patients and that selenium deficiency is associated with changes in     biological markers of endothelial dysfunction and that these changes, in turn, are associated     with worse clinical prognosis.   "
50902|NCT02619331|"     Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin     reactivity to allergens. Multiple factors can contribute to non-optimal results of     conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements,     observer-dependency and absence of traceability.      This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler     Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen     extracts as well as positive and negative controls will be performed in 20 volunteers (11     atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and     allergen concentration) of HSL-DI analysis based on two parameters (area and flow     measurement). In a second step, fifty patients will be tested with birch and grass pollen     extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and     CWFM will be compared.   "
50904|NCT02619305|"     The objective of our study is to determine whether a livelihood intervention can change     economic and psychosocial outcomes of social network ties and geographically proximate     neighbors of impoverished women in rural Uganda.   "
50905|NCT02619292|"     The purpose of this study is to determine if participating in a Mindful Movement Program     (MMP) (learning how to be mindful in one's movement), positively affects the body's immune     functions improves mindfulness and reduces worries about cancer returning. All participants     will be in this study about three months.   "
50906|NCT02619279|"     The objective of the study is to determine whether a livelihood intervention can improve     health and schooling outcomes of the children of woman participating in a livelihood     intervention in rural Uganda.   "
50907|NCT02619266|"     This trail will be carried out to evaluated the effect and safety of acupuncture for the     anorexia in patients with gastrointestinal tract and lung cancers.   "
50908|NCT02619253|"     Primary objective: To assess the safety and tolerability of pembrolizumab in combination with     vorinostat in patients with advanced renal or urothelial cell carcinoma in order to select     the recommended Phase 2 dose (RP2D).      Secondary objectives: (1) To evaluate the overall safety profile of pembrolizumab in     combination with vorinostat; (2) To assess the anti-tumor activity (i.e. objective response     rate, progression-free survival) of pembrolizumab in combination with vorinostat in patients     with advanced renal or urothelial cell carcinoma; (3) To characterize PD-L1/2, immune cell     subsets, and miRs in tumor and/or blood.   "
50909|NCT02619240|"     This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen     for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis     (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation     procedures, will be recruited for this study over a period of 18 months. Clinical likelihood     of TB will be systematically scored according to various clinical parameters. This will     determine the pre-test probability. Clinician will decide if anti-TB treatment is to be     started and patients will be followed up for a minimal of 18 months. Sensitivity,     specificity, positive, negative predictive values and the respective likelihood ratio will be     calculated accordingly.   "
50910|NCT02619227|"     The objective of the study is to determine whether a livelihood intervention can improve     economic and psychosocial wellbeing in rural Uganda.   "
50911|NCT02619214|"     Clinical trial controlled randomized of parallels groups. The study is designed to look for     differences in the oxidative stress level among healthy patients receiving 2 different oxygen     concentrations: 30% and 60% during general anesthesia. Once the patient has been informed,     the affirmative agreement has been obtained and inclusion and exclusion criteria verified the     patients are randomized to 30% or 60% oxygen concentration. In the operating room while     placing the intravenous line, a sample blood is obtained. General anesthesia is induced and     maintained with sevoflurane. After Anesthesia induction the anesthesia machine is fixed in     order to provide the oxygen concentration according to the randomization. One hour later a     second venous sample is obtained. Samples are stored in cold conditions until their analysis     in the laboratories of the biology faculty - Barcelona University.   "
50912|NCT02619201|"     Acute gastroenteritis (GEA) is a public health problem at present, the main cause of vomiting     and consultation in emergencies in children under 5 years. Worldwide, there are about 2     million deaths per year due to gastroenteritis in children under 5 years.      In Mexico, the mortality rate by age in 2013, recorded 28 deaths per 100,000 boys and girls,     in 2013 in our country 2.5 million children between 5 and 17 years engaged in an economic     activity. The occupancy rate for the child population was 8.6: 11.4 for boys and 5.8 for     girls.      NICE guidance gastroenteritis defined as a transient disorder caused by an enteric infection     and characterized by a sudden onset of diarrhea with or without vomiting   "
80125|NCT02237118|"     To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound     management.   "
50915|NCT02619162|"     Open, multicenter phase I with gradual increase in dosage to evaluate the safety and     tolerability of orally administered nintedanib plus letrozole orally (2.5 mg / day) for     patients with breast cancer. Nintedanib is administered twice a day orally for 28 consecutive     days (Days 1-28) in 4-week cycles.   "
50916|NCT02619149|"     The benefit from antibiotic prophylaxis in patients undergoing laparoscopic cholecystectomy     for acute cholecystitis is insufficiently known. The aim of the present double-blind     randomized controlled is to compare piperacilin with placebo in patients undergoing     cholecystectomy for acute cholecystitis with anamnesis not exceeding 5 days. Altogether 100     patients are intended to be included. Primary endpoint is biliary contamination. Secondary     endpoints are postoperative hospital stay, health-related quality of life, pain perception,     postoperative markers of inflammatory response, surgical site infections, infectious     complications other than surgical site infections, health economy and relationship between     symptom anamnesis and bile contamination.   "
50917|NCT02619136|"     MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used     transfusion strategies in patients with myocardial infarction.   "
50918|NCT02619123|"     The Tailored Breast Screening Trial (TBST) is a population-based, non-inferiority randomised     trial aimed at evaluating the impact of tailored screening strategies addressed to     premenopausal women, by using breast density as indicator of risk.      44-45 years old women will be enrolled and invited to undergo a digital mammography. Women     are then randomly allocated in two arms. In the intervention arm, women will receive a     tailored screening strategy according to breast density.      The aim of this study is to assess the impact of a longer screening interval and the     reduction of side effects for premenopausal women.   "
50919|NCT02619110|"     The purpose of this research was to discuss the effect of backward walking treadmill training     on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic     stroke.   "
50920|NCT02619097|"     The primary objectives of the trial are to assess the safety and pharmacokinetics profile of     pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.   "
50921|NCT02619084|"     The main objective of this project is to evaluate the efficacy of subthalamic nucleus deep     brain stimulation (STN DBS) in treating motor and phonic tics in medically refractory     Tourette's syndrome (TS).      Secondary objectives are to individuate and standardize the best electrical parameters for     STN stimulation in TS, to evaluate the efficacy and safety on non-motor TS features, such as     behavioral abnormalities and psychiatric disorders, during chronic STN stimulation, to     correlate the improvement of TS motor and non-motor symptoms to the modification in brain     activity recorded by PET study and to explore the pathophysiology of TS, and to evaluate the     safety of STN DBS in TS patients.   "
50922|NCT02619071|"     Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with     poor prognosis, especially after relapse. High-throughput genomic studies have highlighted     the importance of molecular alteration in the pathophysiology, clinical evolution and     treatment response of AML. In addition, identification of specific gene mutation can be     targeted by specific inhibitors, opening the way to personalized treatments. However, only a     limited number of gene mutations are druggable or actionable, highlighting the need for     additional information to guide treatment choices. Among them, new Drug Screening Tests (DST)     allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells.     Combination of genomic and pharmacologic approaches might therefore improve prediction of     drug effects. There is an urgent need to bring these approaches into the clinic but     feasibility trials are necessary before incorporating them into treatments strategies.The     proposed study is a prospective multicentre feasibility study of a combined chemo-genomic     approach in patients with advanced AML.   "
50923|NCT02619058|"     Considerable progress in the treatment of metastatic melanoma has been made in the past     5years, with the approval of immune checkpoint-blocking antibodies and agents targeting BRAF     mutation. Investigators conducted a open label, dose escalation, phase I clinical trial of to     explore the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of intravenous     administration of autologous NKT Cells in metastatic melanoma patients.   "
50924|NCT02619045|"     This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients     With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this     Follow-up Program Device.   "
50925|NCT02619032|"     This study was a prospective comparative study. The purpose of this study was to investigate     the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and     stress response to the day-case dental surgery in Persons with special needs (PSN). Secondary     aims were to investigate comparatively their effect on patients intraoperative hemodynamic     response and postoperative analgesia.   "
50926|NCT02619019|"     Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it     extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone     in Transuretheral prostatectomy.   "
50976|NCT02618369|"     The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in     patients with painful osteoid osteoma and other benign bone tumors, and in reducing their     pain medication usage. No serious adverse effects are expected to result from this treatment.   "
50977|NCT02618356|"     The primary endpoint is to evaluate the Median disease progression free survival (mPFS).   "
50940|NCT02618837|"     To evaluate the impact on outcomes of the currently accepted antithrombotic strategies based     on the administration of newer P2Y12 receptor blockers (prasugrel and ticagrelor) in a     population of non ST elevated ACS (NSTEACS) patients with an initial invasive indication.      Furthermore, to evaluate the effects of bivalirudin administration in comparison to standard     therapy with unfractioned heparin (plus provisional anti-GPIIbIIIa) in NSTEACSpatients who     undergo PCI and will thus receive these potent antiplatelet agents which may theoretically     favor the occurrence of bleedings.      A combined measure of efficacy and safety endpoints, the so-called net clinical benefit     (NACE), will be considered at early (30 days) and mid term (12 months) follow-up.   "
50927|NCT02619006|"     When immediate clamping of the umbilical cord (ICC) occurs at birth, 20 to 30% of the     fetal-placental blood volume is left behind in the placenta. Preliminary results from our     current study comparing effects of ICC versus placental transfusion from delayed cord     clamping (DCC) show that infants who have DCC have higher ferritin levels at 4 months of age     and more myelin in important regions of the brain. Our objective for this follow-up study is     to see if the effects of placental transfusion persist to three and four years of age. The     investigators plan to enroll only children who participated in the previous trial (Infant     Brain Study/NCT01620008) at birth for assessments at three and four years of age. Assessments     include MRIs and neurodevelopmental testing to examine cognitive, motor, visual, and     behavioral outcomes.      The proposed research addresses two central questions regarding the potential benefits of DCC     on brain myelin development in children who were born healthy at term: 1. Does DCC result in     increased brain myelin deposition at three and four years of age? and 2) Are DCC, iron     stores, and brain myelin content in infancy associated with improved cognitive, motor, and     socio-behavioral outcomes at three and four years of age?   "
50928|NCT02618993|"     The sensory innervation of the face depends on the trigeminal (fifth cranial) which is     divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal     and masseter muscle. The regional anesthesia of the face has grown in recent years for     performing certain actions under light general anesthesia or sedation. The mandibular block     is a simple and reliable technique but little used. Yet it reduces postoperative pain     sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the     oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it     also improves the visibility of the operative field during mandibular osteotomies reducing     bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of     action of the local anesthetic), the V3 block ropivacaine is not evaluated in the     maxillofacial surgery.   "
50929|NCT02618980|"     The primary aim of this study is to compare efficacy of early endoscopy and non-endoscopic     treatment for management of acute upper gastrointestinal (UGI) bleeding in patients with     recent acute coronary syndrome (ACS). This study will also compare rates of surgery, repeated     intervention (endoscopy or TAE), rebleeding and complications between two groups.   "
50930|NCT02618967|"     The purpose of this study is to obtain initial information on the safety and tolerability     (effects good or bad), pharmacokinetics (what the body does to the drug), and     pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.   "
50931|NCT02618954|"     The objective of this study is to determine the longitudinal relation between clinical     remission and ultrasound (US) remission in Rheumatoid arthritis (RA).      At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals     and power Doppler signals) is frequent in patients with RA in clinical remission. Several     longitudinal studies reveal an association of US-detected residual synovitis and risk of     relapse and radiographic progression, in individual patients and joints, over 1-2 years.      However, the longitudinal relation between clinical remission and US remission is not so     well-known and it is possible that clinical remission arrive before ultrasound remission.     Thus arise the question as to whether the presence of US-detected residual synovitis require     to adapt the treatment to ultrasound findings or to simply increase the patient care.      The investigator propose to conduct a prospective, bi-center, non randomized study.   "
50932|NCT02618941|"     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A     vaccinations in patients with Parkinson's disease. Patients, who have already participated in     the AFF008 program will be involved and will receive a second boost immunization with     AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.      In addition, up to 6 patients will be offered participation within an untreated control     Group.   "
50933|NCT02618928|"     This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ±     ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices     across France.   "
50934|NCT02618915|"     A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in     adult males with moderate/severe to severe hemophilia B.   "
50935|NCT02618902|"     A first-in-human clinical trial to treat patients with multiple sclerosis by vaccination with     tolerogenic dendritic cells (tolDC), generated using Good Manufacturing Practice (GMP) will     be conducted. In doing so, the feasibility and safety of administering myelin-derived     peptide-pulsed tolDC in patients with MS will be assessed.   "
50936|NCT02618889|"     The purpose of this research study is to evaluate if patients with psychogenic dystonia     treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and     disability at one month and at three months than those having received placebo injections   "
50937|NCT02618876|"     Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in     children undergoing inguinal hernia repair.      2 groups, 30 patients each   "
50938|NCT02618863|"     the investigators have observed that women may require less CF than men to occlude the     esophageal entrance, and that the routine use of 30 N in women may actually increase the     incidence of airway-related problems. The objective of the current investigation was to test     this hypothesis. In this study, real-time visual and dynamic means were used to assess the     effectiveness of different forces applied to the cricoid cartilage in occluding the     esophageal entrance in men and women. The patency of the esophageal entrance was directly     visualized using the Glidescope Video Laryngoscope in anesthetized and paralyzed patients     with and without CP. Evidence of closure of the esophageal lumen was confirmed by the     inability to introduce a gastric tube (GT) into the esophagus under direct vision. New method     , using Cricometer , was used to measure the applied force .   "
50939|NCT02618850|"     The purpose of this study is to test whether an early metabolic response, measured by PET/CT     scan after the first cycle of chemotherapy, is able to predict which patients with advanced     CRC have a better prognosis.   "
50988|NCT02618213|"     Bronchiolitis in infants and young children often requires respiraty support. In Denmark     Continous Positive Airway Pressure ( CPAP) are routinely used in children with     moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow     Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with     bronchiolitis.      Infants and young children with moderate-severe bronchiolitis and are randomized to either     CPAP or HFOT.   "
50941|NCT02618824|"     Terminal warm blood cardioplegia (TWBC) has been shown to enhance myocardial protection in     adult patients. Even in pediatric patients, the use of cold blood cardioplegia followed by     administration of TWBC will provide cardioprotective effect similar to adult patients.     Histidine-tryptophan-ketoglutarate (HTK), is attractive for cardiac surgeons because it is     administered as a single dose and is claimed to offer myocardial protection for a period of     up to 180 minutes allowing performance of complex procedures without interruption. Merging     the use of TWBC on the use of HTK cardioplegia, especially for pediatric cardiac cases, have     not been investigated. This technique is expected to provide a longer ischemic time and a     protective effect against reperfusion injury.   "
50942|NCT02618811|"     So far, the impact of sarcopenia has been analysed only in patients undergoing traditional     surgical procedures (laparotomy) or those with metastatic spread. As the ERAS protocol     combined with minimally invasive access decreases postoperative metabolic disorders, it seems     possible that it can limit the deleterious impact of sarcopenia as well. The aim of this     study was to investigate whether the use of ERAS protocol in colorectal cancer patients     influences the postoperative risk due to sarcopenia.   "
50943|NCT02618798|"     Background: Thrombosis may be crucial in driving the progression of fibrosis in chronic liver     disease (CLD). The potential role of platelets and platelet activation in this process is     unclear. Platelets participate in inflammation by secretion of pro-inflammatory mediators     which may advance hepatic fibrosis. Hepatitis B virus transgenic mice, developed     significantly smaller necroinflammatory foci and their serum ALT levels were 80% lower, if     they were pre-treated with anti-platelet antibodies. Sinusoidal aggregation of activated     platelets also occurs in chronic hepatitis C in humans. It may contribute to thrombocytopenia     observed in CLD. Platelet activation is generally believed to be compromised in CLD. However,     there is data suggesting that CLD may even be associated with an enhancement of platelet     activation. Measurement of hepatic venous pressure gradient (HVPG) constitutes the most     common method for estimation of portal venous pressure. HVPG is significantly correlated with     histological indices of CLD progression.      Study hypotheses:        1. HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is          associated with an increase in platelet activation.        2. Platelet activation and function is not generally compromised in CLD. Comparison of          platelet function in CLD to a control group of healthy volunteers is intended to clarify          whether CLD leads to a manifest platelet dysfunction      Methods: Study design is observational. 100 patients with CLD of various origins (viral,     alcoholic, cholestatic) scheduled for routine HVPG measurement will be enrolled. 30 healthy     volunteers will donate blood as a control group. Platelet function and activation will be     evaluated by multiple electrode aggregometry (primary outcome variable area under the curve     (AUC). Plasma levels of P-selectin (ELISA), PFA (Platelet Function Analyzer) 100™ parameters     (EPI-CT and ADP-CT), percentage of P-selectin, GPIIb/IIIa, thrombin receptor positive     platelets after stimulation (flow-cytometry) will constitute secondary outcome parameters.     Plasmatic coagulation will be evaluated by rotational thrombelastometry (ROTEM). Platelet     count and routine coagulation parameters will be monitored. HVPG measurement by hepatic vein     catheterization and patient blood sampling will be carried out via the internal jugular vein.     Blood sampling in volunteers will be performed via the antecubital vein      Study Rationale: If higher levels of platelet activation are associated with increased HVPGs,     this would provide an insight into the pathogenesis of CLD. It would also point toward a     possible benefit of anti-platelet therapy in CLD. Verification of platelet dysfunction in CLD     is relevant to clinical practice in anaesthesiology and intensive care as procedures are     often postponed in CLD-patients for fear of bleeding complications. CLD patients may also     receive prophylactic platelet concentrates prior to interventions which is costly, fraught     with risk of bacterial infection and may be unnecessary in the absence of platelet     dysfunction.   "
50944|NCT02618785|"     This study finds premedication Hyoscine-N-butylbromide before hysterosalpingography have a     potential effect for diagnosis of proximal tubal obstruction in infertile women. The     investigators did a double-blind, randomized placebo-controlled trial   "
50945|NCT02618772|"     Laceration repair can cause significant anxiety in children. As open wounds account for     21-25% of injuries in children presenting to the emergency department, the management of     anxiety is of great importance. Anxiety can often lead to poor patient cooperation and the     use of potentially excessive physical restraint. High rates of procedural anxiety have also     been correlated with increased rates of negative behaviours after discharge.      The current standard of care for suture closure of lacerations throughout most of Canada is     to provide local analgesia only. The literature has therefore focused on finding anxiolytic     adjuncts to local analgesia.      Midazolam is an ideal adjunct due to its fast onset and short duration of action with an     excellent safety profile. The advantages of the IN route are less pain on administration when     compared to the IV and IM routes, and increased acceptability compared to the rectal route in     older children. Oral midazolam also has poor palatability.      While the onset of INM at 5-10 minutes, and duration of 20-40 minutes make it an ideal     candidate for anxiolysis in the ED its use has been limited by the common side effect of     nasal irritation, burning and lacrimation when it is administered in its droplet form. The     recent development of mucosal atomization devices (MAD) has resolved this issue by delivering     30-μ particles to the nasal mucosa.      Previous studies investigating the use of INM for laceration repair in the pediatric ED have     demonstrated that INM is safe but most used non-validated measurement tools to assess anxiety     and facilitation. Only one of these studies used atomized INM, retrospectively examining     safety as the primary outcome. The authors reported an excellent safety profile for INM using     the mucosal atomization device MAD-300 (Wolfe Tory Medical Inc.). The use of atomized INM for     anxiolysis during pediatric laceration repair has not been evaluated prospectively.      Most studies have focused on preschool aged children (<6 years). While studies have     demonstrated that the prevalence of procedural anxiety is higher in younger children, up to     51% of children age 7-12 years experience high levels of procedural distress. The     effectiveness of INM in the pre-adolescent age group is, therefore, yet to be determined.      It is hypothesized that INM will reduce anxiety in children age 2-12 years undergoing     laceration repair and will facilitate the successful completion of suturing by the physician.   "
50946|NCT02618759|"     The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared     to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.   "
50947|NCT02618746|"     COPD is the fourth leading cause of death in the world and is the only one of the top five     illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a     higher prevalence and death rate for COPD than many other countries in Europe. The disease is     incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite     maximal medication and strategies such as pulmonary rehabilitation and home nurse support,     many patients remain vulnerable, socially isolated and report difficulty in accessing their     local health services. Research has shown that patients have worsening symptoms for an     average of three to four days before they are admitted to hospital with an exacerbation of     COPD. This suggests a window of opportunity to intervene. Early warning and contact via     innovative technology may treat symptoms earlier, improve patient confidence / quality of     life and simultaneously reduce health care visits or admissions. However, there is a large     gap between the postulated and empirically demonstrated benefits of electronic Health     Technologies. In addition, there is a lack of robust research on the risks of implementing     these technologies and their cost-effectiveness has yet to be demonstrated, despite being     frequently promoted by policymakers as if this was a given issue. In addition, the     evidence-base for telehealth is not well-reported in peer reviewed journals and hence there     continue to be difficulties experienced in convincing clinicians, hospital managers and     stakeholders that investment in such technologies will enable reductions in other aspects of     healthcare delivery over time.      This project attempts to provide robust justification of the effectiveness of     telerehabilitation by the implementation of a randomized controlled trial blindly assigning     COPD patients to: i) a home care and telerehabilitation group remotely monitored by a     specialised private health care centre (Filoktitis - group A) or ii) a hospital-based     rehabilitation group managed at a regular base through weekly visits by personnel at a state     University rehabilitation centre (group B). iii) A third group that receives usual care     (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is     also included.   "
50948|NCT02618733|"     Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient outcomes,     a Phase III pivotal efficacy and safety study with a duration of up to 12 months comparing     ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in acute coronary     syndrome patients on ASA background, have demonstrated superiority of ticagrelor over     clopidogrel in the prevention of fatal and non-fatal cardiovascular events. Currently, the     mechanism for this mortality reduction remain uncertain. One hypothesis is a adenosine     mediated theory that ticagrelor has been shown to enhance adenosine-induced vasodilation.     Several experimental and clinical studies support the hypothesis that adenosine could reduce     cardiac ischaemia reperfusion damage. Moreover, recent study has demonstrated that ticagrelor     enhances adenosine-induced coronary vasodilatory responses in healthy humans. However, there     are no available data on coronary circulation effects after chronic treatment of ticagrelor     in patients with ACS who have altered resting coronary blood flow dynamics due to advanced     coronary artery disease.   "
50949|NCT02618720|"     To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day     before surgery) and intravenous cephalosporin (before surgical incision) with that of     intravenous cephalosporin alone (standard of care) in combination with oral placebo on the     incidence of SSI within 30 days after elective colorectal surgery.   "
50950|NCT02618707|"     Many variables measured in critically ill patients have been used to estimate severity of     disease, prognosticate morbidity and mortality, evaluate costs of treatment, and finally     indicate specific treatment and monitor the adequacy of treatment and its timing. It is     unlikely that one measurement can replace all of these, but in the remainder of this     manuscript the investigators will show that lactate levels may come close. Although in our     mind strongly linked to tissue hypoxia, lactate levels follow many more metabolic processes     not related to tissue hypoxia and, therefore, subject to many disturbances found in various     clinical situations   "
50951|NCT02618694|"     This randomized comparative study assesses the safety and efficacy of the posterior     retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal     approach and suppose that this new technique is a safe and effective alternative to the     standard approach.   "
50952|NCT02618681|"     To investigate the feasibility of the earlobe crease as an early prognostic predictor for     acute myocardial infarction(AMI) in Chinese population.   "
50953|NCT02618668|"     The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic     stability, recovery time ,patient & doctor satisfaction scores during Endoscopic Retrograde     Cholangiopancreatography.   "
50954|NCT02618655|"     The study will use several laboratory diagnoses in the diagnosis of patients with fever，to     find out which will be more helpful for making an accurate diagnosis in the early period of     Tickborne Diseases.   "
50955|NCT02618642|"     Plotting i/t curve before a series of phototherapy treatments and after their completion.     Pain threshold assessment with algometer. i/t curve. Creation of 3 test groups: 1 - Piler     light + red filter, 2 - Piler light + blue filter, 3 - Piler light without a filter. Creation     of a numerical coefficient for i/t curve.   "
50956|NCT02618629|"     The aim of this Phase I study is to determine the absorption, metabolism, and excretion of     14C-Z-215 in healthy male subjects following a single oral administration at a     therapeutically relevant dose level (20 mg).   "
50957|NCT02618616|"     This will be a randomized, double blind, placebo controlled, parallel group study in     approximately 120 subjects with moderate to severe psoriasis with a PASI score of at least     10. Following run-in subjects will be randomized to receive either oral 30 mg ZPL-3893787     once daily or placebo once daily for 12 weeks.   "
50958|NCT02618603|"     Shoulder pain after stroke is a very common, causing significant morbidity disease.     Subacromial and subdeltoid (SASD) bursitis are common causes of pain or disability of the     shoulder joint in stroke patients. Traditional therapeutic approaches for the shoulder pain     therapy including pharmacotherapy, injection therapy, physical therapy, and behavioural     modification. Unfortunately, these therapy methods may not be effective in many patients and     long term benefit after treatment is transient, the outcomes may also be incomplete or     non-existent. Botulinum toxin A (BoNT-A) is a neurotoxin that can inhibit not only the     acetylcholine at the neuromuscular junctions but also other neurotransmitters such as     glutamate, substance P and calcitonin gene related peptide, all of which have been indicated     in pain transmission. Despite the therapeutic benefit of BTX in alleviating painful muscle     spasms, its efficacy in SASD bursitis conditions is less clear. So we perform this study to     examine the efficacy of ultrasound guided SASD injection with BoNT-A in reducing refractory     shoulder pain after stroke.   "
50959|NCT02618590|"     This is a multi-center retrospective study, designing to access the best treatment strategy     in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second     line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is     defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1     is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1     criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what     second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.   "
50960|NCT02618577|"     NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised,     multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation     using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic embolism,     or cardiovascular death in patients with AHRE and at least two stroke risk factors but     without AF. The trial will be conducted in several European countries.   "
50961|NCT02618564|"     The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate     magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different     doses and administration times. The primary outcome is number of bowel motions produced.     Secondary outcomes include the quality of bowel cleansing and patient tolerability.   "
50962|NCT02618551|"     Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the     thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct     vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality     of life and the number of exacerbations related to severe asthma.      This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation     phenomenon (worsening of bronchial obstruction during exercise in patients with asthma     contributing to worsening shortness of breath).   "
50963|NCT02618538|"     Some women have a higher risk than others of developing breast cancer. Unhealthy lifestyles,     high breast density, family history, obesity, the presence of biomarkers associated with     early neoplastic changes (considered alone or in combination) are just some of main factors     that can increase the risk of breast cancer. Women with a higher risk may need to undergo     more intensive screening activities, which include more frequent inspections and the     possibility of experiment different types of tests. Instead, low risk women could be screened     at longer intervals in order to reduce the screening harms (false positive results,     overdiagnosis, radiation exposure, discomfort caused by the test itself, etc.) The ANDROMEDA     Study aims at creating the possibility to customize the screening paths through a combined     analysis of the above mentioned risk factors. Women consenting to be involved in the study     will be asked to provide information on their lifestyle habits and reproductive history.     Furthermore a blood sample will be collected for further bio-molecular analysis purposes.   "
51775|NCT02607917|"     This research will test the effect of mass media or mass media plus a clinic based education     program will improve appropriate aspirin use for cardiovascular disease prevention. It is a     group randomized design of 24 geographic areas in Minnesota with adjacent states serving as     controls.   "
51000|NCT02618057|"     Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in     children. The clinical course is typically self-limited and benign; however, rare cases of     severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to     study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation     or pleural effusion in children.   "
51040|NCT02617524|"     Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the     feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic     Valvuloplasty (BAV).   "
50964|NCT02618525|"     BACKGROUND AND OBJECTIVES      The purpose of this study is to assess whether the loss of motor response to supraorbital     pressure can be an alternative to that of jaw thrust to predict optimal condition for     laryngeal mask airway (LMA) insertion in children.      METHODOLOGY      Fifty children (ASA I-II), aged 2 to 10 years, scheduled to receive general anesthesia that     required LMA insertion were randomized to receive either supraorbital pressure (SOP) (n = 25)     or jaw thrust (JT) (n = 25), after the loss of verbal response and body movements with a     standard anesthetic. When motor response to the study intervention was absent, the LMA was     inserted. Outcome parameters were ease of mouth opening, LMA insertion score, requirement of     additional propofol to increase the depth of anesthesia, occurrence of coughing, swallowing,     laryngospasm and gross purposeful movements during or within one minute of LMA insertion, and     the number of failed insertions.   "
50965|NCT02618512|"     This study is to evaluate the safety and tolerability of intravenous (IV) administration of     SBC-103 in previously studied, SBC-103 treatment naïve patients with mucopolysaccharidosis     III, type B (MPS IIIB, Sanfilippo B) who participated in the NGLU-CL01 study. The NGLU-CL01     study was a non-interventional study that evaluated structural brain abnormalities and blood     brain barrier (BBB) integrity by magnetic resonance imaging (MRI) and cerebrospinal     fluid/serum albumin index.   "
50966|NCT02618499|"     The purpose of this study is to determine if oxytocin administration immediately after     delivery of the infant modifies the volume of placental transfusion in healthy term infants.   "
50967|NCT02618486|"     The investigators' earlier study reported a high prevalence of chronic periodontitis among     obese Malaysian adult population. Non-surgical periodontal therapy (NSPT) has been shown to     effectively reduce microbial load and contributes to reduction in periodontal parameters and     inflammatory burden up to 6 months post-therapy. This study will cast light on the effects of     obesity on chronic periodontitis (CP) patients following NSPT. The objectives of the study     were to quantify and to compare the periodontal pathogens, serum and salivary interleukins in     obese and non obese with CP following NSPT.   "
50968|NCT02618473|"     The aim of this study was to investigate the effect of a new motion correction algorithm on     image quality and diagnostic utility in unselected patients undergoing coronary cardiac     computed tomography, and to investigate if this motion correction algorithm can compensate     for the usual use of intravenously medication (beta-blockers) before the scan.   "
50969|NCT02618460|"     Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.      Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood     Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA),     phase-contrast MRI), which could be used in combination with structural MRI in a single     acquisition session, have been identified to investigate in more detail renal function and     structure, opening the possibility to estimate local renal diffusion and blood perfusion,     beyond providing high-resolution anatomical accuracy.      Preliminary to the identification of novel imaging biomarkers of renal disease progression,     perfusion and diffusion MR sequences need to be optimized for the renal compartment.     Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and     diffusion changes in pathological kidneys as compared to normal and physiological condition.      The objective of this study is to provide normal control NCE-MRI sequences to be used as     reference for the investigation of perfusion and diffusion changes in the kidney of patients     affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal     dominant polycystic kidney disease).   "
50970|NCT02618447|"     The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography     (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and     hypertrophic potential in patients with liver cancer presenting for portal vein embolization     (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help     determine which patients could safely and successfully undergo PVE and subsequent resection     of tumor. By comparing 4D PC MRA results with invasive catheter measurements the     investigators will validate the flow findings. Further regression/correlation analysis with     functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology,     and outcomes will help the investigators to determine the ability of 4D PC MRA to predict     functional status and hypertrophic potential of the liver prior to PVE and hepatectomy     allowing for better patient selection and reduced morbidity/mortality.   "
50971|NCT02618434|"     The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810     in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity     Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged     6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.     The frequency of impulsive aggression behaviors will be assessed as a primary outcome.     Additionally, the severity and improvement in impulsive aggression, and quality of life     measures for the subject and caregiver will be assessed using validated scales.   "
50972|NCT02618421|"     The purpose of the study is to determine prevalence of lower urinary tract symptoms in     population aged 40 years or over, in China, Taiwan and South Korea using latest ICS     definition.   "
50973|NCT02618408|"     The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810     in the treatment of impulsive aggression in subjects with Attention Deficit/Hyperactivity     Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged     6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.     The frequency of impulsive aggression behaviors will be assessed as a primary outcome.     Additionally, the severity and improvement in impulsive aggression, and quality of life     measures for the subject and caregiver will be assessed using validated scales.   "
50974|NCT02618395|"     Bioavailability study   "
50975|NCT02618382|"     This is a single center single arm study of 50 patients to 1) determine the safety of     tranexamic acid in the chronic subdural hematoma population following surgical drainage of     chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the     rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be     compared to historical controls. This study intends to be a prerequisite to a large     nationally funded randomized control trial.   "
53416|NCT02586402|"     The purpose of this study is to evaluate the safety and efficacy of multiple intravenous     doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on     dialysis.   "
50978|NCT02618343|"     Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment     that is often treated with oral or intravenous anti-emetic medications. Research Design/Plan:     This will be a randomized equivalence study comparing the reduction in a patient's reported     level of nausea after treatment with either Ondansetron or IPA Methods: Patients who report     nausea and/or vomiting in the normal evaluation and care of after calling 911 for Emergency     Medical Care will be offered enrollment in the study. A short script will be attached to the     outside of each study packet providing information about the study and its risks and     benefits. Verbal or written (waiver of informed consent will be requested) permission will be     obtained to start randomization. If the patient agrees to enroll then the study packet will     be opened and utilized. All Advanced Life Support Ambulances in the San Antonio Fire     Department will have sealed numbered opaque boxes or envelopes with either: 70% Isopropyl     Alcohol swabs or ondansetron. Six Visual Nausea Severity Scoring cards will be provided with     a marking pen to record timed nausea levels before and upon arrival to the Emergency     Department and 15 minutes after treatment whichever comes first.      Clinical Relevance: This treatment has not been studied in the unique environment encountered     by Paramedics in the Pre-Hospital setting. If this treatment is found to be effective, it     many offer a very simple, extremely inexpensive and non-invasive (basic life support)     approach for the treatment of nausea.   "
50979|NCT02618330|"     The aims of this study were to compare health related quality of life, comforts     degrees，retention effectiveness, and failure rates as well as survival times between two     clear overlay retainers with different thicknesses, thus to provide basis information     regarding appropriate selections of the thickness of clear overlay retainers.   "
50980|NCT02618317|"     Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly     prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter     lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence     remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF     and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the     anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus     H. M-EDTA and C were also evaluated as to their safety versus H.      Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis     (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil)     were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions     concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both     investigators and patients were blinded to treatment allocation. The primary end-point was a     10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding     and lock solution-related adverse events were the primary safety end points. Logistic     Regression was performed to evaluate differences in PF rates among the treatments (SPSS     version 13.0, IBM, USA).      Based upon the pilot-study data, the clinical trials has being executed in order to verify     whether the three lock solutions have the same performance or not.   "
50981|NCT02618304|"     In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness     and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4     meibomian gland dysfunction, participants will be treated using conventional treatment     modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic     examination, tear-film lipid layer thickness, and ocular aberration are going to measured and     compared.   "
50982|NCT02618291|"     This study aims to test the efficacy of a comprehensive assessment and management tool (AGE:     Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly     patients followed in family medicine. Family practitioners will be randomised either to the     intervention, consisting of a yearly screening for eight geriatric syndromes accompanied by a     management plan in case of positive screening, or to usual care. Level of functioning and     quality of life of patients in both arms will be assessed over two years.   "
50983|NCT02618278|"     This study aims to evaluate the whether receiving physiotherapy early after onset of the     problem is better than waiting a few weeks to see if it gets better before starting     physiotherapy. 80 people with sciatica will take part in the study, half of which will     receive physiotherapy 2 weeks after seeing their G.P. The other half will receive     physiotherapy at the usual time, around 6 weeks after seeing their G.P.   "
50984|NCT02618265|"     The investigators want to verify whether mobile application based on stroke strengthen     prevention management is more effective than traditional management model or open stroke     management platform. Whole blood-impedance based platelet aggregation(WBA) method and     VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized     anti-platelet drug selection. Endpoint event is defined as stroke death or relapse. Primary     measure outcomes are change of the stroke recurrence rate and mortality after secondary     prevention.   "
50985|NCT02618252|"     Patients with difficulty intravenous access frequently have delay of care in emergency     departments because Emergency Department (ED) personnel could not establish intravenous (IV)     access for diagnostic blood test or treatment. The ultrasound machine or near-infrared     devices have been used to improve this situation but no study has ever compared which machine     is more efficient. This study is designed to investigate whether the ultrasound or Vein     Viewer, which is a near-infrared device, is more efficient.   "
50986|NCT02618239|"     Non-absorbable, fermentable residues in the diet increase intestinal gas production and     induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however,     prebiotics, which are also fermented by colonic bacteria have been shown to improve this type     of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota and     colonic biomass induced by prebiotics.      Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d)     for 3 weeks; they will also receive a standard diet during three days. The following outcomes     will be measured immediately before, at the beginning and at the end of the treatment: a)     number of gas evacuations during daytime for 2 days on the standard diet, by means of an     event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal,     by means of a barostat; c) microbiota composition by fecal analysis.   "
50987|NCT02618226|"     Prospective study of diagnostic accuracy of optic nerve sheath diameter measurement (index     study) in traumatic brain injury with simultaneous invasive intracranial pressure monitoring     as the reference standard.   "
50989|NCT02618200|"     Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic     (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive     cancer foci non-invasively, but additional progress is needed for the technique to be     accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can     improve the detection of cancerous tumors. As a first step in this direction, we need to     create a database with MR images, 3D ultrasound images, and corresponding histopathology     results, in patients treated by radical prostatectomy for prostate cancer. This is the     purpose of the present study.      In a later stage (outside the scope of this study), we will be learning how to combine these     images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD     system, and we will assess the performance of the new CAD. We expect this future system to     improve the detection of prostate cancer and to reduce the number of patients requiring     biopsy.   "
50990|NCT02618187|"     A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287     in Subjects with Mild-to-Moderate Ulcerative Colitis.   "
50991|NCT02618174|"     Encouraging individuals to eat vegetables is difficult. However, recent evidence suggests     that using social-based information might help. For instance, it has been shown that if     people think that others are eating lots of fruit and vegetables, that they will consume more     of these foods to match the 'norm'. The purpose of this study was to determine whether a     liking social norm (information about how much others like vegetables) would be effective at     encouraging people to eat more vegetables and to examine whether these effects are sustained     beyond initial exposure (i.e. whether the effect of the norm persists on food selection 24     hours alter).   "
50992|NCT02618161|"     TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate     CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility     trial.      SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014     Study Duration Recruitment Duration 18-24 months      Study Centre Southend University Hospital NHS Foundation Trust      Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual     dysfunction at various time points.      Number of Participants 50 participants      Main Inclusion Criteria        -  Patient age >18 years        -  Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0        -  Any Gleason score        -  Any PSA level        -  Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous          TURP/HoLEP Laser Prostatectomy        -  Any Metastatic Disease        -  IPSS>20        -  Pubic arch interference        -  Lithotomy position or anaesthesia not possible        -  Rectal fistula        -  Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse          events will be compared using Fisher's Exact Test. Toxicity score means will be compared          using two-sample permutation t-tests, and PSA relapse-free survival will be estimated          using Kaplan-Meier and compared using log-rank tests.   "
50993|NCT02618148|"     The purpose of this study is to determine whether safety Study of Hormone replacement therapy     (HRT) with herbals( Garlic oil+Nattokinase) for estrogen deficiency symptoms in     perimenopausal and postmenopausal women.   "
50994|NCT02618135|"     This project involves creating a novel and personalised BCI training system that targets     social and communication difficulties, and inattentive symptoms problems often found in     ASD/ADHD children. 20 participants between the age of 8 and 12 will be recruited and they     will undergo 24 training sessions over an 8-week period. During these sessions, the children     will play a computer game interface specifically designed to train attention and facial and     emotional recognition, while using our BCI device. To further reinforce the treatment, the     training system has been enhanced with the inclusion of an eye-tracker to target the lack of     preferential eye contact that children with ASD exhibit. The investigators hypothesize that     participants will show improvements in social skills and attention post treatment.   "
50995|NCT02618122|"     This non-interventional study aims primarily at assessing the clinical effectiveness and the     impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it     represents an attempt towards gaining experience on the routine use of trabectedin in daily     clinical practice in a representative sample of Greek subjects with aSTS.   "
50996|NCT02618109|"     B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite     enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies     in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells     -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was     associated with poor response to chemotherapy. However, few studies have been done on     childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B     cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its     significance has never been evaluated in human cancers. The purpose of this study is to     prospectively evaluate the immune status of children newly diagnosed with first relapse of     B-cell ALL, and to compare results with those of children treated for B-ALL in complete     remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells,     deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell     death 1) and thymopoiesis will be evaluated. The investigators assume that increase of     immunosuppressive cells proportions could be associated with B-ALL relapse.   "
50997|NCT02618096|"     The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus     dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.   "
50998|NCT02618083|"     Retinal detachments correspond to a separation of the neuroepithelium from the pigment     epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional,     traumatic (postoperative) or rhegmatogenous (in relation to a tear).      Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile     membrane. It can also measure the hemodynamic parameters of retinal arteries.      A preliminary study showed a correlation between systolic velocity in the central retinal     artery and postoperative visual acuity.      The aim of this study is to confirm those preliminary data.   "
50999|NCT02618070|"     In this functional magnetic resonance imaging study, effects of different information of fat     content of high or low fat will be examined in FD patients and healthy volunteers (n=30,     respectively). These data will provide a better understanding of symptom generation following     food ingestion in general as well as in patients with respective functional gastrointestinal     disorders.   "
51001|NCT02618044|"     Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of     choice for patients suffering of gastro-esophageal reflux (GER). However, long term     instrumental evaluations of GER after LRYGB are not available.      The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric     Bypass (LRYGB) on gastro-esophageal function.   "
51002|NCT02618031|"     This study seeks to investigate the capillary index score (CIS) to further improve patient     selection of endovascular treatment (EVT) in acute ischemic stroke (AIS).      The hypothesis or idea being tested:      Patients with favorable CIS who are successfully revascularized with EVT can have successful     outcomes with an extended time window for treatment.   "
51003|NCT02618018|"     The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic     toric IOL in cataract surgery.   "
51004|NCT02618005|"     Human immune function and intestinal microbiota are suggested to be altered within     long-duration stay in space. Accumulated evidences on earth support that Lactobacillus casei     strain Shirota (LcS) is a promising probiotic strain on improvement of immune function and     intestinal microbiota. This study aims to investigate the impact of long-duration spaceflight     as well as intake of LcS on the international space station (ISS), on immune system and     intestinal microbiota in astronauts.   "
51005|NCT02617992|"     The development of a standardised imaging protocol to detect post endoscopic mucosal     resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post     EMR scar with endoscopic findings.   "
51006|NCT02617979|"     The study of readmission is in its infancy in the surgical world, and there are no     prospective studies, to the investigators' knowledge, evaluating the efficacy of     interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and     their caregivers will play a key role in any useful intervention to reduce readmission.     Therefore, the investigators' approach is to target perioperative education and engagement of     patients and their caregivers in the postoperative recovery of pancreatectomy patients.   "
51007|NCT02617966|"     Background:      Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss     and night blindness. Researchers want to learn about rod and cone function in healthy people     and people with retinal disease. They want to know if how well a person sees in the dark can     test the severity of retinal disease.      Objectives:      To find out if how well a person sees in the dark can test the severity of retinal disease.     To find out if this can help detect retinal disease and track its changes.      Eligibility:      People ages 5 and older with:      Retinal disease OR      20/20 vision or better with or without correction in at least one eye      Design:      Participants will be screened with medical and eye history and eye exam. Those with retinal     disease will also have:      Eye imaging: Drops dilate the eye and pictures are taken of it.      Visual field testing: Participants look into a bowl and press a button when they see light.      Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the      dark with their eyes patched for 30 minutes. Then they get numbing drops and contact      lenses. Participants watch lights while retina signals are recorded.      Visit 1 will be 3 8 hours. Participants will have up to 6 more visits over 6 12 months.     Visits include:      Eye exam and imaging      Time course of dark adaptation: Participants view a background light for 5 minutes then      push a button when they see colored light.      Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button     when      they see colored light.      For participants with retinal disease, ERG and visual field testing   "
51008|NCT02617953|"     Investigation of objective tinnitus diagnosis method through measurement of continuous     resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation     (rTMS) treatment of tinnitus.   "
51009|NCT02617940|"     The aim of this study is to evaluate the efficacy of oral hygiene orientation singly,     compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary     and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal     surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion     will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups:     oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and     12 months regarding clinical and radiographic lesions progression. The costs and     cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction     and impact on quality of life will also be investigated. Poisson regression analysis will be     performed in order to compare the groups, through clinical and radiographic criteria. This     test will also be used to assess the association between the group and patient discomfort and     parents' satisfaction. Time, costs and impact on quality of life of the treatments will be     compared by Student's t test. For all analyses, the significance level will be set at 5%.   "
51010|NCT02617927|"     The safety assessment of Vedolizumab during pregnancy in IBD patients.      The primary objective of this study is:        1. To quantify incidence of major structural birth defects and other birth outcomes in          infants born to women with UC/CD with exposure to Entyvio compared to women with          exposure to other biological agents or conventional IBD therapy during pregnancy        2. To assess the health and developmental status of infants up to 1yr of age.   "
51021|NCT02617771|"     Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D     supplementation in children with RRI, with no conclusive information.      Therefore, we designed a prospective, single-blind, clinical trial to evaluate whether oral     supplementation with vitamin D from October to April reduces the global health burden of     recurrent respiratory tract infections in a primary care setting.      The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can     reduce the number of respiratory tract infections in children diagnosed with recurrent     respiratory tract infections the seasons before.      Secondary objectives was the assessment of Vitamin D supplementation benefits on global     socioeconomic burden of recurrent respiratory tract infections in a primary care setting,     according to number of visits to the primary care paediatrician and use of antibiotics due to     respiratory tract infections.   "
51039|NCT02617537|"     The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as     betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to     appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a     placebo-controlled comparative study   "
65524|NCT02428010|"     Study to evaluate the safety and performance of the Twelve TMVR System   "
51011|NCT02617914|"     The acute respiratory distress syndrome (ARDS) is common condition in critical ill patients     affecting 7.2 people / 100,000 population / year and more than 7% of patients with invasive     mechanical ventilation for more than 24 hours. ARDS carries a high hospital mortality of up     to 48% and consumes large amounts of critical care resources. ARDS patients often present     with severe hypoxemia that is refractory to conventional treatment and are thus evaluated for     extracorporeal membrane oxygenation (ECMO). However, uncertainty regarding the appropriate     indication for ECMO and clinical evidence for ECMO as a rescue treatment are still     controversial. In 2012 Grasso and colleagues therefore presented a case series of influenza A     (H1N1) ARDS patients describing the use of esophageal pressure measurements for     individualized PEEP titration to achieve an end expiratory plateau pressure of the lung     (PPLATL) of 25cm H2O. After performing the measurements in 14 patients, ventilator settings     could be adjusted in half of these patients by increasing PEEP which resulted in an increase     of oxygenation measures to an extend that criteria for extracorporeal support where no longer     met and conventional treatment with invasive mechanical ventilation could be continued.     However, uncertainty remains as to whether these results are generalizable to ARDS of any     cause. In addition, increasing PEEP might impact on cardiac function and might therefore be     associated with clinical important hemodynamic effects in these patients.      The investigators aim to evaluate hemodynamic changes in patients with severe ARDS in which     an individualized PEEP treatment strategy can be employed. ARDS will be defined and     stratified according to the Berlin ARDS definition. A naso-gastric probe capable of measuring     esophageal pressure will be inserted directly after admission to the ICU as previously     described. Invasive mechanical ventilation and oesophageal pressure measurements will be done     using the GE Healthcare Carescape R860 ventilator. A pulmonary artery catheters (Edwards     CCOcomb) will be inserted to evaluate the hemodynamic parameters of cardiac output, pulmonary     artery pressures and left atrial pressures. Volumetric parameters will be measured using     tanspulmonary thermodilution devices (Edwards EV1000). Cardiac function will be addressed in     addition by the use of a predefined echocardiography protocol.   "
51012|NCT02617901|"     The Greulich and Pyle technique (G&P) is that most commonly used to assess bone age in     children, particularly in the context of suspected skeletal dysplasia. However it has been     shown not to be applicable to children of Asian and African ethnicity and may not be     applicable to United Kingdom (UK) Caucasian children, who are now relatively more mature and     larger than children of the mid 1930's (when G&P was developed). It is generally agreed that     updated standards are required for rapid and reliable bone age assessment. The development of     such standards requires irradiation of normal children. To do this ethically, radiation     exposure must be kept as low as possible. Two recent studies suggest that bone age assessment     can be reliably achieved from dual-energy x-ray absorptiometry (DXA) scans. As far as the     investigators are aware, the Tanner & Whitehouse (TW3) method, which is preferred by some     (e.g. endocrinologists and nutritionists), has not been assessed from dual-energy x-ray     absorptiometry (DXA) scans - although not the main focus of this study, because of its     popularity amongst certain specialties, the investigators shall be assessing the TW3 method     also. Modern techniques should not only be available as textbooks, but should also be     available in digital (on-line) format and where possible integrated with hospital PACS     systems. The investigators believe that their team has the required experience and expertise     to successfully carry out such a project. Before conducting the required large     cross-sectional study, the investigators must first confirm that DXA can in fact replace     radiographs for bone age assessment in children; which is the objective of this current     study.   "
51013|NCT02617888|"     Purpose        1. To investigate the effects of cardiac imaging radiation on the induction of DNA          double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked          hair follicle cells.        2. To estimate whether the use of breast shields in cardiac computed tomographic          angiography (CCTA) limits the effective radiation exposure of breast tissue.   "
51014|NCT02617875|"     The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic     multifunctional teleconsultation system. This system consists of on-line transmissions of     vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a     trained emergency physician (tele-EMS physician) uses software-based guideline conform     algorithms for diagnosis and treatment.      At the prehospital emergency scene half of the patients will receive this telemedicine-based     approach and the other half the conventional emergency physician-based care.   "
51015|NCT02617862|"     The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA)     to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical     Incorporated (PCI) (Pleasanton, CA).   "
51016|NCT02617849|"     This is a multi-center, open-label, Phase II clinical trial evaluating pembrolizumab in     combination with carboplatin/paclitaxel as a treatment in unresectable locally advanced or     metastatic melanoma.   "
51017|NCT02617823|"     The purpose of this study is to determine if a lateral positioning of the pregnant woman     after epidural analgesia increases the incidence of unilateral functioning epidurals.   "
51018|NCT02617810|"     The purpose of this study is to evaluate effect of multiple-dose administration of     JNJ-42847922 on the single-dose pharmacokinetics of oral midazolam and single-dose     pharmacokinetics and pharmacodynamics of (R)- and (S)-warfarin after oral administration of     racemic warfarin.   "
51019|NCT02617797|"     Urinary stress incontinence ( SUI ) is defined as an involuntary loss of urinary Complaint no     effort According to the Consensus of the International Continence Society (Society Continene     International - ICS) . SUI Prevalence of adult female Population and 25 % to 30 %.However,     despite the high prevalence, many women who have symptoms of SUI or not seek treatment remain     without resolution of symptoms.Then there is the possibility of using non-invasive     radiofrequency and non-ablation in external urethral meatus in order to stimulate collagen     production, as one of the pathophysiological mechanisms of stress urinary incontinence is the     collagen deficit in the urethral wall. It is a randomized clinical trial and the group     experimental will utilize radiofrequency and cinesioteraphy ( clinical and in home) and the     group control utilize turn off- radiofrequency and cinesiotherapy(clinical and in home). The     protocol f the cinesiotherapu is the same both the group, and the protocol radiofrequency the     group experimental will 5 sessions (one per week) with temperature 38ºC during 2 minuts. The     group control will 5 sessions (one per week) but the radiofrequency will off but glycerin is     heated, for masking for the patient, during 2 min. The result of the treatment is assessed by     pad test 1 hour and have others outcomes ( quality of life- Sf-26 ans King Health- and sexual     function- FSFI questionaire)   "
51020|NCT02617784|"     This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its     metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for     end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed     oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.   "
51022|NCT02617758|"     The purpose of this study is to evaluate the bioequivalence of the new formulation of     fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy     participants.   "
51023|NCT02617745|"     The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in     the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter     is the variation in platelet count during the radio-chemotherapy phase. The main objective is     to identify early in Stupp protocol a group of patients having high risk to undergo     thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of     platelet monitoring for patients treated with Stupp protocol wil be proposed.   "
51024|NCT02617732|"     The purpose of this study is to evaluate the effects and safety of Tianqi Capsule on glucose     variability in patients with type 2 diabetes by continuous blood glucose monitoring system.   "
51025|NCT02617719|"     Comprehensive Geriatric Assessment is an effective process to identify and address the needs     of older patients. In the United Kingdom this usually takes place in acute care or in the     patients home. This project will assess the feasibility of implementing this service in     primary care.   "
51026|NCT02617706|"     EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site     infections (SSI).   "
51028|NCT02617680|"     There is accumulating evidence that inappropriate depth of anaesthesia is associated with     increased risk of postoperative complications including risk of death. The aim of this study     was to identify factors determining the effective end-tidal concentration (EEtC) of     desflurane, duration of wash in and wash out phase, and to estimate the risk of perioperative     awareness in patients undergoing elective neurosurgical procedure.   "
51029|NCT02617667|"     The objective of this study is to compare the safety, efficacy, and tolerability of two     different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for     the treatment of the signs and symptoms of Dry Eye Disease (DED).   "
51030|NCT02617654|"     Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin     production, albeit at low levels. Finding means to increase this production would be of     tremendous interest, since residual C-peptide concentrations >0.1 nmol/l previously have been     shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of     ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late     complications. Liraglutide may through its incretin effect directly potentiate beta-cell     function, but also holds the potential to be mitogenic for these cells.      The hypothesis of the present trial is that treatment with liraglutide will not only have a     direct effect on beta-cell function, which is more or less immediately observed, but also     progressively improve C-peptide concentrations over time.   "
51031|NCT02617641|"     Acute coronary syndromes (ACS) are one of the leading causes of coronary artery disease     mortality, and among the top reasons for health care utilization in Canada. Physical activity     counselling is a core component of secondary prevention interventions because increased     physical activity is associated with reduced mortality risk, improved quality of life,     reduced coronary risk factors, and reduced health care utilization. Despite these health     benefits, between 40% and 60% of patients after an ACS event are insufficiently active.     Web-based interventions offer innovative alternatives for intervention delivery via the     Internet in secondary prevention. However, there is a paucity of randomized controlled trials     testing, in ACS patients, computer-tailored interventions that include videos within the     tailored algorithm. The purpose of this multicenter randomized controlled trial is to test a     web-based intervention, TAVIEenM@RCHE, that uses tailored-videos of a nurse, the 'virtual     nurse', aimed at increasing physical activity through walking in ACS patients.   "
51032|NCT02617628|"     This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison     System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of     an injectable opiate addiction medication (extended release naltrexone) given before reentry     into the community that might help to improve reconnection to healthcare and other support     systems, and possibly help reduce recidivism.   "
51033|NCT02617615|"     A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the     Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending and Multiple Oral     Doses of MB-110 in Healthy Volunteers and to Evaluate the Antiviral Activity of MB-110 in     Hepatitis C Virus Infected Subjects   "
51034|NCT02617602|"     Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular     performance and allows for timely interventions based on predetermined algorithms. The aim of     this prospective randomised study is to evaluate the effect of GDT on major complications in     children undergoing radical correction of congenital heart defects, complicated by acute     heart failure. Goal directed therapy will be implemented with the aid of transpulmonary     thermodilution and based on predetermined algorithms.   "
51036|NCT02617576|"     To determine if patient satisfaction, participation, and image quality improves with flavored     oral contrast for MR enterography.   "
51037|NCT02617563|"     The purpose of this study is        -  to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior          approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade          I).        -  To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion          procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar          Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar          Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar          Interbody Fusion) are used in surgical practice and to describe long-term safety and          effectiveness in a broad patient population of patients with degenerative lumbar disc          disease .   "
51401|NCT02612805|"     This study evaluates the effects of the combined exercise training (aerobic more resistance)     and of the aerobic exercise training isolated compared to control group, which performed only     stretching and relaxation, in the treatment of type 2 diabetes (T2DM). The two exercise     interventions and the control procedure are performed in aquatic environment.   "
51038|NCT02617550|"     This study is intended to investigate the effect of nitroglycerin on vericiguat in patients     with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat     acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in     the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important     to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used     as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.   "
51041|NCT02617511|"     The purpose of this project is to evaluate whether omega-3 fatty acid supplementation     (combined eicosapentaenoic acid and docosahexaenoic acid [EPA/DHA] supplement) augments the     effects of a 12-week resistance training program in older men. Outcome variables include     inflammatory biomarkers in the systemic circulation, body composition and performance     measures. The specific inflammatory markers in the blood include: C-reactive protein, tumor     necrosis factor-α, interleukin-1β, and interleukin-6. Remaining parameters include: body     composition (as assessed by dual energy x-ray absorptiometry), muscle strength (as assessed     by chest press and leg press one-repetition maximum strength tests), and functional ability     (as assessed by timed up and go test as well as the 6-minute walking test).   "
51042|NCT02617498|"     Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in     this a prospective study.Patients enrolled in the study divided into two groups according to     the day of surgery. The study population was divided into two groups; group (A) Parenchymal     liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver     transection was performed by spray diathermy (SD).   "
51043|NCT02617485|"     The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20     (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients     with CD20-positive diffuse large B-cell lymphoma.   "
51044|NCT02617472|"     This study will assess the effectiveness of a new pelvic floor exercise device in     strengthening pelvic floor muscles and treating urinary incontinence among women who are     experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks and     results will be collected through self-assessment questionnaires and clinical pelvic     examination. Effectiveness outcomes will be tracked over the duration of the trial and     measured against historical symptoms.   "
51045|NCT02617459|"     To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.   "
51047|NCT02617433|"     Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis     of the affected skeletal muscles. There have been several studies reported positive     relationship between muscle mass and amount of neuromuscular junction. The purpose of this     study is to find relationship between muscle mass and muscle relaxation time.   "
51048|NCT02617420|"     This study plans to learn more about how children use their asthma medicines. The     investigators would like to see if special electronic monitoring devices that connect to     smartphones and computers can help children to better manage their asthma   "
51049|NCT02617407|"     Children undergoing Hematopoietic Stem Cell Transplantation (HSCT) have significant     difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a     significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effective in     reducing dental plaques while containing no additives found in other toothpastes that can     cause increased gingival irritation. The investigators hypothesize that improved oral hygiene     in HSCT recipients and better plaque control may result in reduced oral inflammation,     decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related     systemic bacterial infections. The overall goal of this prospective randomized (2:1) pilot     study is to determine whether incorporation of the Livionex® toothpaste in the research     regimen could reduce dental plaque.   "
51050|NCT02617394|"     Occasionally, doctors need to be able to see whether the diaphragm - a muscle in the chest     that helps control breathing - is moving properly. If the diaphragm is paralyzed or not     moving properly, this can affect a person's breathing. After certain nerve blocks - where a     part of the body is frozen using local anesthetic - the nerve controlling diaphragm movement     can be anesthetized, causing diaphragm paralysis. Ultrasound can be used to see the diaphragm     and measure its movement, but the easiest and fastest way to do this is debatable. The     investigators wish to compare two ultrasound-based methods to image diaphragm movement to see     which one offers the quickest and easiest way to determine if the diaphragm is paralyzed.   "
51076|NCT02617056|"     It is generally acknowledged that patients with dementia are best cared for at home. However,     outbursts of various behavioral disturbances, e.g., combativeness, appear in most cases and     often necessitate institutionalization. These outbursts are often without apparent warning,     which limits preventive interventions. The measurement of the electrical activity of the skin     is well-studied as an indicator of stress or agitation. The investigators propose to monitor     the electrical activity of skin in patients with dementia in order to determine whether any     sign of agitation may occur before the outburst. If skin electrical activity gives sufficient     warning, then preventive interventions may be tried. If successful, the ability to predict     and prevent outbursts of behavioral disturbances will allow patients to be cared for at home     for longer periods. It is the primary aim of this project to determine whether skin     electrical activity gives such a warning; possible preventive measures will be the subject of     future studies.   "
51051|NCT02617381|"     This is not a validation study of a questionnaire. This is a multicenter diagnostic study,     assessing the sensitivity and specificity of a simple structured questionnaire, to identify     patients requiring further haemostatic investigations, in pre-operative patients. This study     will also allow for the assessment of the sensitivity and specificity of the routine care     strategy.      All patients are recruited during the pre-anaesthesia visit by an anaesthesiologist, in     different anaesthetic sectors each day of the week, so that different types of surgery are     represented.      Each day (from Monday to Friday), the first 2 eligible patients will be offered to take part     in the study.      Routine care strategy is not modified by the study protocol. In addition, the simple     structured questionnaire will be completed by the patient with a research assistant after the     pre-operative consultation As recommended in diagnostic studies, the gold standard (see     secondary endpoint paragraph) will be performed consistently in all patients to avoid     verification bias.      The improvement of screening for the need of further investigations by use of the     questionnaire compared to routine care will be measured counting how many patients are     adequately reclassified with the questionnaire compared to the routine care strategy,     regarding the gold standard (using the Net Reclassification Index).   "
51064|NCT02617212|"     The purpose of this study is to investigate whether the immediate definitive abutment     connection to dental implant is effective in preventing marginal bone loss when compared to     the conventional treatment with late abutment/implant connection, which include three     disconnections and reconnections.   "
51052|NCT02617368|"     Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of     keratometric data in differentiating moderate KC and FFK from healthy corneas.      Study participants were recruited from the Cornea Outpatient service in a consecutive if     eligible basis. Two study groups were formed: a)KC group included patients those were     diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich     classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c)     Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus     Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced     operator in a consistent way.   "
51053|NCT02617355|"     This study is designed to compare a new prototype surgical magnetic drape made with     bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.   "
51054|NCT02617342|"     This study is being done to examine the impact of an interactive, social robotics program in     helping children with autism spectrum disorders (ASD) understand emotions and how to better     recognize emotions while interacting with others. Eligible families will be randomized to     either the robot intervention (n=20) or a no intervention (TAU; n=20) condition for 8-14     weeks. Assessments will occur at pre- and post-intervention as well as weekly for both     conditions.   "
51055|NCT02617329|"     The purpose of this research was to investigate the clinical effects on the ESWT treatment of     shoulder and neck pain.   "
51056|NCT02617316|"     The purpose of this research is to investigate the differences of landing patterns while     running in different speed with barefoot and wearing shoe.   "
51057|NCT02617303|"     Falls are an important risk factor for fragility fractures. Both are associated with the     ageing process and as they rise also increase the risk of mortality, disability and     dependency. Interventions to prevent falls have been based on multifactorial approaches but     the outcomes have shown little effectiveness. Lately, it is being recommended interventions     which foster physical exercise incorporating it to daily life activities. The OTAGO exercise     programme is based on easy physical exercises for older adults and has shown cost-effective     outcomes for falls prevention and its consequences.   "
51058|NCT02617290|"     The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®)     have shown promising results in the respective TRITON and PLATO trials making of prasugrel     and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC     Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS     patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of     stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the     reduction in death in a meta-analysis.      The field of elective PCI (stable patients) has not been studied with these 2 new drugs and     clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor     is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple     stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported     by scientific evidence. More than half of PCI patients undergo elective stenting for proven     ischemia and/or stable angina, a relatively safe procedure with the use of the latest     generation of stents. However complications remain either frequent when considering     PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients     or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for     improvement with these two newest drugs.      The investigators propose to perform a multicenter international study in stable patients     undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The     investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor     over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and     myocardial injury) without significant excess bleeding (BARC definition).   "
51059|NCT02617277|"     This study will assess the safety, tolerability and pharmacokinetics of AZD1775 given orally     in combination with intravenous MEDI4736. Secondly, the immunogenicity, pharmacodynamics, and     preliminary anti-tumour activity will be determined in patients with refractory solid tumours   "
51060|NCT02617264|"     To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot     at time of biopsy.   "
51061|NCT02617251|"     Many studies have shown that deprived patients consumed more healthcare resources than     non-deprived patients, in particular in terms of increased length of stay (LOS) and     readmission rates, which has an impact on hospital efficiency and the healthcare system as a     whole. There are many types of indicators available to assess deprivation in a hospital     setting and French decision makers are currently using reliance on public aids to allocate     additional funding to hospitals, based on the percentage of deprived patients they admit.     However there are limits to this method: it only assesses one dimension of deprivation, the     target population often does not know about the existence of those aids, and they have a     clear threshold effect. An alternative solution is to use ecological deprivation indices     which are obtained by aggregating different variables measured at a specific time and place,     i.e. the patient's place of residence at the time of care. One such index, the FDep , was     developed specifically in France, although others such as the Carstairs index and the     European deprivation index also exist.      The primary objective of this study is to study the association between deprivation, measured     by the FDep, and hospital care efficiency in paediatric and neonatology patients, measured by     the difference between patient LOS and the national average LOS of their diagnosis-related     group, DRG). The secondary objectives are to carry out a budget impact analysis on the impact     of deprivation for hospitals with a paediatric or neonatology ward, to study the association     between deprivation and readmission at 15 days, to study the relation between FDep and the     currently used deprivation indicators, and to assess the added value of the FDep compared to     those indicators and whether or not it should be used in routine practice.      In order to do so, an exhaustive retrospective study using the French hospital claims     database will be carried out for the years 2012-2014. Deprivation indices will be calculated     based on patients' postcode. The primary endpoint will be calculated using the national LOS     present in the French national cost study. Similarly, the budget impact will look at the     difference between production costs derived from the national cost study after adjusting for     LOS and the statutory health insurance's tariffs, which will allow us to assess whether a     hospital stay is associated with a gain, a loss or is budget-neutral for the hospital.     Readmissions at 15 days will be identified through record linkage.      Descriptive analyses will summarise both hospital and patient characteristics. Uni- and     bivariate analyses will be carried out by focusing of the variables of interest (e.g. average     deprivation index by legal status of the hospital, mean LOS depending on the number of     paediatric beds etc.). The deprivation index will be divided into quantiles as is the norm     and the endpoints will be assessed for each of those quantiles. An ANOVA (or a Kruskal-Wallis     test if the ANOVA hypotheses are not met) will test whether the results differ between each     quantile. For readmission rates, a Chi² test will be performed.      In order to study the association between deprivation and the endpoints, the investigators     will model each endpoint using as the main explanatory variable the deprivation index. Three     main types of explanatory variables will be added to the model: patient characteristics (age,     sex, severity level etc.), hospital characteristics (legal status, size, number of full-time     equivalent etc.) and environment/context characteristics (number of paediatricians for 1,000     inhabitants, rural vs. urban area etc.).      In order to assess the added benefit of using the deprivation index vs. the current     indicators, a sub-cohort will be constructed in Paris teaching hospitals (AP-HP) as     unfortunately, whether the patient receives public aids is not present in the hospital claim     database but is available only at the local level. The investigators will look at the     distribution of patients with public aids in each quantile of the deprivation index and run     the previous models using the two types of indicators one after the other and comparing the     statistical performance of each pair of models.   "
51062|NCT02617238|"     Randomised two parallel groups multicenter study using a Prospective Randomised Open Blinded     End-point design (PROBE), aiming at comparing the efficacy of a therapeutic strategy     targeting the normalisation of arterial stiffness for reducing cardiovascular (CV) and renal     events, in comparison with a classical therapeutic strategy implementing the European Society     of Hypertension-European Society of Cardiology (ESH-ESC) Guidelines, in patients with     essential hypertension and medium-to-very high CV risk.   "
51077|NCT02617043|"     The study was designed to evaluate the feasibility and safety of hypofractionated     whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer     after breast conserving surgery in Chinese population.   "
51078|NCT02617030|"     Investigation in 3 steps the transition of young people with chronic diseases. FIRST STEP:     qualitative survey. Interviews with carers, young people and parents. Chronic Diseases     studied: epilepsy, HIV, sickle cell disease, obesity. SECOND STEP: Delphi consensus survey.     Vote on internet : carers, patients' associations, young people and family. Chronic Diseases     studied: all. THIRD STEP: validation survey. Vote on internet : young people. Chronic     Diseases studied: all.   "
51402|NCT02612792|"     The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV gel     in treatment of mandibular degree II furcation defects in comparison to PRF and open flap     debridement (OFD) alone.   "
51063|NCT02617225|"     The United Nation's International Children's Emergency Fund (UNICEF) is supporting Saba     Shikha Abihyan (SSA) (Education-for-All Mission) of the Government of Assam (GoA) under their     Water-Sanitation-Hygiene in School (WinS) program to improve WASH facilities, practices and     institutionalize WASH in school settings. Under the WinS program, UNICEF piloted a group hand     washing program in 100 elementary schools. Multiple past studies have shown that handwashing     is an effective intervention to reduce diarrheal diseases and respiratory tract infections,     but the evidence on the interventions or programs that can achieve this behavior change is     mixed and limited in case of school setting. The main objective of Daily Handwashing for an     Ailment-free Life (DHaAL) program was to institutionalize handwashing with soap before     consuming mid-day meals and after using toilets among elementary school students. DHaAL is     implemented on the Mid-day Meal platform where free meals are given to all students attending     government schools.      In addition to the standard DHaAL intervention, several pilot phase schools also received an     additional program for a holistic and participatory development of school systems for health,     nutrition, learning outcomes and wellbeing of children called Child Friendly School System     (CFSS). Although CFSS is not a WASH intervention it can develop systems and processes and     offer longer support from and implementing agencies which help DHaAL Intervention also.      This evaluation study seeks to answer whether DHaAL improved handwashing practice before the     mid-day meals in rural lower primary schools as a primary research question. The intermediate     outputs and secondary outcomes evaluated in this study include functionality of handwashing     infrastructure at school, handwashing practice after toilet use, and availability of and use     of handwashing facilities at homes (indirect effect). The evaluation study has other     supplemental operations research objectives to help improve the program in future.   "
56890|NCT02540967|"     The objectives of this study are to investigate the safety and effectiveness of Gadovist.   "
51065|NCT02617199|"     Acute pancreatitis is a common urgency with a mortality rate of up to 30% , decreased blood     flow in the pancreatic microcirculation. It seems to be the main cause of the pathophysiology     of acute pancreatitis. Today, there have been many attempts in the management of pancreatitis     but no established management seems to be ideal. The epidural block is an anesthetic     technique used to provide highly peri and post-operative analgesia, also plays an important     role in improving the gastrointestinal vascular perfusion (due to sympathetic blockade that     this technique produces) so this anesthetic technique is proposed as an alternative to both     clinical treatment as an analgesic for acute pancreatitis.   "
51066|NCT02617186|"     During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera     attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted     via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses     a similar minimally invasive approach, but the very precise instruments involved with RTS     allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the     surgeons increased range of motion during the surgery, and research demonstrates that RTS has     a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better     results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has     not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a     prospective manner.      There are two major barriers against the widespread adoption of robotic thoracic surgery. The     first barrier is the lack of high-quality prospective data. To our knowledge, there are no     prospective trials comparing VATS to RTS for early stage lung cancer. The second major     barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived     higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake     the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy     for early stage lung cancer.      Prospective randomization will eliminate the biases of retrospective data and will serve to     determine whether there exist any advantages to Health Related Quality of life (HRQOL) or     patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a     prospective cost-utility analysis, this trial will provide the highest quality data to     evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian     health system.   "
51067|NCT02617173|"     Oligozoospermia, refers to a low concentration of sperm. A low sperm count or poor sperm     quality is the cause of infertility in about 20% of couples with fertility problems, and a     contributory factor in a further 25% of couples. In the majority of cases, no cause can be     found. For mild male infertility, intra uterine insemination (IUI) is the procedure of choice     with a pregnancy rate of 6.5%. In IUI, sperm is inserted using a thin, flexible catheter     directly into a woman's uterus.      Azoospermia affects 1% of the male population and 20% of male infertility situations. Over     50% of azoospermic cases are due to testicular failure, including absence or failed     production as well as low production and maturation arrest during the process of     spermatogenesis. ICSI allows successful fertilization even with immature sperm obtained     directly from testicular tissue. This is done through TESA (Testicular sperm aspiration) or     TESE (Testicular sperm extraction). In cases of TESE small strips of testicular tissue are     extracted with the intention of finding few viable sperm cells to be used for IVF or ICSI.     Men with non-obstructive azoospermia have 0 to 3 mature spermatids per seminiferous tubule in     contrast to 17-35 mature spermatids in men with normal spermatogenesis. TESE success rates     are approximately 50% but differ according to etiology. Unfortunately, there is no method of     pointing out where sperm may be found. TESE is accompanied with pain, tissue loss, reduced     success in future TESE due to tissue scaring and testosterone deficiency.      The complex process of spermatogenesis includes maturation of young spermatids into     spermatozoas, a process which takes approximately 74 days. During spermatogenesis,     spermatogonial stem cells are transformed into spermatids and released from the seminiferous     tubule epithelium into its lumen. Non-motile spermatozoa are transported through the     seminifreous tubules to the epididymis by testicular fluid secreted from the Sertoli cells     with the aid of peristaltic contraction. During transport through the epididymis, sperm cells     develop the ability to progress forward, undergo capacitation and attach and penetrate the     egg.      The electric charge of the spermatic cell has been termed zeta potential (electrokinetic     potential) and is defined as the electric potential in the slip plane between the sperm     membrane and its surroundings. Mature sperm possess an electric charge of −16 to −20 mV.      In the animal study conducted, positive electrical current with a low amplitude bellow     sensation level was situated around the scrotum of four normospermic and one oligospermic     male pigs. At the end of the research the concentration of spermatocytes in the epididymis     obtained in surgery was found to be 200 to 1600 percent above the baseline.      Our intention is to evaluate if positive electrical current with a low amplitude bellow     sensation level situated on the scrotum will increase the concentration of spermatocytes in     the ejaculate.      If our hypothesis is confirmed this may become a method for treating male infertility. The     period of improvement is still unclear.   "
51068|NCT02617160|"     Pump therapy is gaining popularity as a treatment mode for patients with type 1 diabetes.     Utilizing pump therapy requires the development and application of a new spectrum of     theoretical knowledge and practical skills by the patient. Furthermore, occasionally there is     a need to tailor the pump settings, i.e. the insulin correction factor, carbohydrate ratio,     basal plan and insulin activity time, in order to optimize and improve glucose control. These     adjustments are based on collected information including insulin delivery, blood glucose     measurements, continuous glucose monitoring data, meals and so on. Analyzing this multitude     of information and data is overwhelming for many of the patients, caregivers and health care     providers. Unfortunately, not all physicians have the needed expertise to fully fulfill this     task, and for those who do, it is time consuming. Thus, a summary of the data with insulin     dose adjustment suggestions is missing. An automated tool for pump setting adjustments will     improve glycemic control without escalating the burden on patients and the health care     system. Such advisor can assist the professional team during routine follow-up and the     patients between visits.      To address this challenge, the investigators developed the MD-Logic Pump Advisor (MDPA),     which automatically analyses treatment information, learns patient's needs and accordingly     suggests adjustments in insulin dosing. The MDPA uses information gathered from glucose     monitoring, insulin dosing and meal data during daily routine home care. Following a 5 minute     data collection and analysis, the algorithm learns and suggests pump-setting changes for     optimization of glucose control.      The objective of the research project, called MD-Logic Advise4U, is to test the MD-Logic pump     advisor in a clinical study. The study will generate data necessary to address the safety,     reliability, and efficacy of this algorithm   "
51069|NCT02617147|"     The purpose of this study is to assess the influence of vitrectomy on changes in central     choroidea and comparing the results in imaging of the choroidea with two different OCT     devices.      This is a prospective, open, non-randomized, observational, MPG study This study will be     performed at the Department of Ophthalmology, Medical University of Vienna.      40 Patients who undergo vitrectomy will be included into this study. The investigation will     help to gain new information about the effects of vitrectomy on the choroid.   "
51070|NCT02617134|"     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell     immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.   "
51071|NCT02617121|"     This study was designed to compare the effects of gabapentin and ramosetron on PONV in     patients undergoing laparoscopic gynecologic surgery.   "
51072|NCT02617108|"     Patients who want to go TCRS will randomly divided 2 groups. In Group 1 (100 patients), a     Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed     into the uterine cavity at the end of the operation for five days. In Group 2 (110 patients),     women will not receive any of the treatment (comparison group). All subjects underwent two     further hysteroscopy, one and three months after the initial surgery. At the second or third     look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.   "
51073|NCT02617095|"     The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in     the treatment of moderate to severe Dry Eye Syndrome.   "
51074|NCT02617082|"     This study is designed to evaluate the feasibility and safety of partial breast irradiation     for low risk DCIS after breast-conserving surgery.   "
51075|NCT02617069|"     The aim of this prospective randomized double-blind study was to compare the efficacy of     botulinum toxin injection in epicardial fat pads for preventing recurrences (in early     postoperative period) of atrial tachyarrhythmia in patients undergoing cardiac surgery.   "
51079|NCT02617017|"     Parkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher     prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor complications     that impair quality of life for patients with PD. The mechanisms of these dyskinesias remain     unclear, but several hypotheses have been put forward: non continuous, pulsatile stimulation     of dopaminergic receptors, or alterations of other neurotransmitters within the motor     striatum such as glutamate and serotonin.      Few strategies are now available to treat severe LID:        -  Medications: reduction of dopaminergic treatment, addition of amantadine,        -  Functional neurosurgery. The purpose of this study is to investigate the efficacy of          buspirone in PD patients suffering from dyskinesias. The role of serotonin in the          occurrence of LID was recently demonstrated in transplant PD patients and a test          double-blind, single dose was achieved. Following administration of 10 mg oral          buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of          buspirone had already been reported in 1991 and 1994, but identification of buspirone as          a serotonin receptor agonist has been reported more recently.      This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa     induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial,     the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible dose/effect     relationship and (4) check the hypothesis of a better therapeutic ratio using the association     of buspirone and amantadine instead than a single drug.   "
59860|NCT02502032|"     To investigate the effects of different doses of cisatracurium pretreatment on     succinylcholine-induced fasciculations.   "
51080|NCT02617004|"     The purpose of this study is to prospectively validate the new risk model, based on minimal     residual disease (MRD) response level and oncogenetic status by comparing historical results     of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia     chromosome negative, B lineage ALL, aged 18 to 59 years old).   "
51081|NCT02616991|"     The purpose of this study is to determine whether systematically performing computed     tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during     the venous phase of opacification) in addition to thoracic CT angiography in women with     suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism     detection rate.   "
51082|NCT02616978|"     This is an Internet survey to collect data on the use of the Cefaly device to treat migraine     attacks in regular Cefaly users.   "
51083|NCT02616965|"     This is a Phase I Trial to assess the feasibility of Romidepsin combined with Brentuximab     Vedotin for patients requiring Systemic Therapy for Cutaneous T-cell Lymphoma.   "
51084|NCT02616952|"     The purpose of this study is to determine whether Yiqi Suoquan Tang, a Chinese Herbal     decoction, is effective in the treatment of female stress urinary incontinence.   "
51085|NCT02616939|"     Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.   "
51086|NCT02616926|"     Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world. For patients     with intermediate HCC (BCLC stage B), transarterial chemoembolization (TACE) has been     recommended as the standard therapy in many clinical practice guidelines. The combination of     TACE and radiofrequency ablation (RFA) has also been reported as an effective treatment.     However, more and more retrospective studies have reported better therapeutic efficacy of     hepatic resection than TACE for intermediate HCC. The purpose of this study was to compare     the efficacy of hepatic resection versus TACE+RFA for the treatment of intermediate HCC     through prospective randomized clinical trial.   "
51087|NCT02616913|"     This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001,     R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF)     exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo,     and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.   "
51088|NCT02616900|"     The eSight Quality of Life and Efficacy Study (eQUEST) is a prospective cohort study     intended to demonstrate the functional vision and Quality of Life (QoL) improvement provided     by eSight Eyewear to persons with significant visual impairment resulting from various eye     conditions. The multi-site study will evaluate the efficacy of the eSight device for various     Activities of Daily Living (ADLs) across a broad range of subject ages and disease types.   "
51089|NCT02616887|"     Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid     tumors, investigators have designed this study to assess feasibility of SBRT in selected     patients with spine metastases.   "
51090|NCT02616874|"     The BCN02-Romi study aims to evaluate a combined kick and kill strategy using the most     immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency reversal     agent available at present time (romidepsin) in a cohort of early-treated HIV positive     individuals.   "
51091|NCT02616861|"     Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and     pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers,     in fed and fasted states, in a single-dose crossover study.      Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses     of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple     ascending-dose study with optional up-titration of dose level within cohort.   "
51092|NCT02616848|"     Treatment of triple negative breast cancer (TNBC) relies heavily on different regimes of     chemotherapeutic agents but remains one of the most challenging subtypes to treat because of     the lack of specific therapies. Despite being sensitive to chemotherapy, many women with TNBC     relapse quickly, developing locoregional recurrence or visceral metastasis. Toxicity and     chemotherapy resistance are still major limitations in the treatment of patients with TNBC.     Despite current trend of targeted therapy development, cytotoxic agents are a mainstay of     treatment of patients with breast cancer. Further research into new combination of different     compounds is needed in order to maximise benefit, whilst minimising toxicity.      The phosphoinositide 3-kinase (PI3K) pathway is associated with resistance to a variety of     anti-tumor agents. This has been described pre-clinically with cytotoxic chemotherapeutic     agents with varying mechanisms of action including taxanes, and DNA-damaging agents. In the     clinic, activated PI3K in tumors has been correlated with decreased response to therapy and     worse clinical outcomes.      The recent biological findings suggest that a PI3K/mammalian target of rapamycin (mTOR)     inhibitors may increase the efficacy of chemotherapeutic agents which are considered standard     of care (SOC) for the treatment of several solid tumors.      The study by the Unitaed state Oncology Research of Huston and the Sarah Cannon Cancer Center     randomized 1830 patients with high risk breast cancer to the standard adjuvant treatment with     adriamicin cyclophosphamide followed by paclitaxel versus the experimental adjuvant treatment     with adriamicin taxotere (AT) followed by paclitaxel. At 5-years of follow up, the AT     followed by paclitaxel produced significantly better overall survival (p=0.054) and improved     disease free survival (DFS) (p=0.19). Among TNBC patients both DFS (74% versus 79%, p=0.1)     and overall survival (OS) (79% versus 84%, p=0.037) were better in experimental arm. However,     the main reasons for patients being taken off study treatment were toxicity (85 patients in     the control arm and 128 in the experimental arm) and consent withdrawal (18 patients in the     control arm and 30 patients in the experimental arm). For this reason, research into     alternatives has intensified, thus resulting in the discovery and development of new     compounds with a more tolerable profile as compared with paclitaxel.      Among the total of 762 patients enrolled into Eisai Metastatic Breast Cancer Study Assessing     Physician's Choice Versus E7389 (EMBRACE) trial, 19% had TNBC. Of note, eribulin was most     effective in hormone receptor-negative patients and in TNBC patients, who had a 29% risk     reduction. Treatment with eribulin was well tolerated. Neutropenia, leucopenia, peripheral     neuropathy, and asthenia/fatigue were the most common adverse events reported at Common     Terminology Criteria for Adverse Events (CTCAE) grades 3 and 4. Neutropenia was the most     common adverse events reported at CTCAE grade 4 in the eribulin group (24.1%).      Based on findings to date, eribulin is an attractive agent, and its role in combination with     new compounds such as everolimus deserves further investigations. Their combination might     lead to more profound effects on tumor cell biology of triple negative metastatic breast     cancer.      During the course of the trial, dose reductions for each combination will be permitted in     patients who cannot tolerate the starting dose   "
51093|NCT02616835|"     This research seeks to study the physiological effects of theta-burst transcranial magnetic     stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.   "
51107|NCT02616653|"     This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar     levels or more) when the palpation method is used in obese parturients at term in the lateral     position compared to the sitting position.      Hypothesis: The L3-L4 intervertebral space identified by the palpation method will be two     levels higher than the level determined by ultrasonography (US) more often in the lateral     than in the sitting position.   "
51094|NCT02616822|"     Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a     major modifiable risk factors and one of the most important public health problems. Mortality     from cardiovascular disease increases progressively with increasing blood pressure (BP) in a     linear, continuous and independent. The pathophysiological mechanisms involved in the     pathogenesis of hypertension exhibit metabolic abnormalities, which are related to     endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of     plants, but in our food, mainly present in red wine and grapes, has shown protective effects     in cardiovascular diseases, such as preventing the damage caused by oxidative stress,     decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective     effect of vascular endothelium, with increased release of nitric oxide and decreased     production of free radicals in animal models, but human studies are limited and insufficient     to clarify the possible effects of trans-resveratrol (biologically active form) on     endothelial function, blood pressure and central aortic pressure in treated hypertensive     individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol     supplementation on endothelial function in treated hypertensive patients.   "
51095|NCT02616809|"     This study aims to test the short-term effects of intermittent standing, slow cycling and     slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure     among pre-hypertensive and pre-diabetic adults.   "
51096|NCT02616796|"     The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving     social gaze behavior in children with fragile X syndrome (FXS). The investigators will use     the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills.     Importantly, the investigators propose to examine the effects of this treatment probe on     brain and behavior.   "
51097|NCT02616783|"     This study will evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir     alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by     assessing spine and hip bone mineral density (BMD) measured at Week 48 in     virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.   "
51098|NCT02616770|"     To evaluate the safety and tolerability of S-1226 composed of perflubron with ascending doses     of carbon dioxide (4%, 8%, and 12% CO2) administered over 2 minute nebulisation to healthy     subjects.   "
51099|NCT02616757|"     Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone     lesions. Literature to date describes little agreement between clinicians on specific     prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has     shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given     its association with the mechanical properties of bone. There has been further exploration     into the use of quantitative ultrasound to assess bone density by measuring the velocity of     the ultrasound transmission over the bone. To determine whether the QUS can provide     prognostic information with respect to cyst healing, recurrence or fracture with a SBC,     further study is needed.   "
51100|NCT02616744|"     A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of     oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase     inhibitors as adjuvant treatment.   "
51101|NCT02616731|"     To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in     women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.   "
51102|NCT02616718|"     This is a prospective multicenter study of patients diagnosed with a medium to giant     incisional hernia (transverse defect >7 cm). Patients referred to the surgical outpatient     clinic are invited to participate in the study. As a standard, all patients who are examined     for incisional hernia undergo CT scan according to a hernia protocol, before planning of     surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient     clinic once again and either treated conservatively without surgery, or scheduled for     elective surgical repair of the hernia.      If surgery is planned, the patients participating in the study undergo an additional CT scan     in hernia protocol, within two weeks prior to surgery (follow-up scan).      If a conservative non-surgical approach is chosen, patients can still participate in the     study and will undergo an additional CT scan after 28-32 weeks.   "
51103|NCT02616705|"     Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may     affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis     (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or     cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity     of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of     various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical     cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4     concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.   "
51104|NCT02616692|"     This non-interventional cross-sectional online survey will evaluate preferences among     patients with self-reported HCC. The survey will ask patients to express their preferences     regarding descriptions of HCC treatments, which will include sorafenib (which will be     described as 'oral anti-cancer therapy'), repeated transarterial chemoembolization (TACE),     and hepatic arterial infusion chemotherapy (HAIC). Please note that all interventions that     patients may have received before completing this online survey were given regardless of     their participation in this survey. Questions also include asking patients to rank various     treatment characteristics (e.g., mechanism of action, risk of adverse effects, etc.) relative     to each other. The ultimate goal is to better understand patient perceptions of these     treatments and to provide evidence to help in patients' and physicians' treatment     decision-making in HCC.   "
51105|NCT02616679|"     The current study aims to validate several novel cognitive tasks expected to be sensitive to     brain impairment in specific anatomic regions affected in preclinical Alzheimer's     disease(pAD). The tasks are validated in 60 cognitively and clinically normal participants     ages 60 - 85, inclusive, against reasonably well-established biomarkers of Alzheimer's     disease, including 1) simultaneous positron emission tomography (PET) [18F]Flutemetamol     amyloid and CT imaging and 2) to the extent data is available from other studies,     participants' brain MRI and cerebral spinal fluid (CSF) amyloid and tau.   "
51106|NCT02616666|"     A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness     between dapagliflozin and Standard of Care (SOC).   "
51109|NCT02616627|"     Aims:        1. To determine whether BMD and muscle mass were associated with fractures and other          adverse events in dialysis patients.        2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and          vitamin D on low bone mineral density and sacropenia in dialysis patients.      Method:      In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone     microstructure parameters, and body composition in chronic dialysis patients. Also, the     investigators plan to use blood testing to measure the blood level of FGF23, calcium,     phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for     these participants to evaluate clinical courses and outcomes. Patients will receive DXA     (including BMD and body composition) tests and blood work at baseline and one-year. Muscle     power and physical performance will be measured at baseline, 6 months and one-year.   "
51110|NCT02616614|"     Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75%     gel. This study is designed to evaluate the safety and efficacy of this formulation in     subjects with Acne Vulgaris   "
51111|NCT02616601|"     This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil     0.5% cream against the brand product (Carac) in subjects with actinic keratoses   "
51112|NCT02616588|"     The overall goal of this study is to evaluate the feasibility of a veteran patient navigator     and social work counseling intervention in veterans with advanced stage cancer at the Denver     VA Medical Center. This is a tiered intervention: patients first receive the veteran patient     navigator component of the intervention, and then if additional patient needs are present     they receive the social work counseling component of the intervention. The overall     intervention will help veterans communicate their care preferences with their providers.This     is a study of behavioral and care strategy interventions and involves no investigational     drugs or devices.   "
51152|NCT02616068|"     This study evaluates the non-inferiority of the new transdermal patch dosage form containing     loxoprofen sodium (100 mg - Daiichi-Sankyo) in comparison with oral Loxonin® (60 mg tablet -     Daiichi-Sankyo) for the treatment of acute traumatic injuries.   "
51113|NCT02616575|"     Aims: The purposes of this study are        1. to create a smart living environment with home care system using GPS and cloud-based          services for elderly people.        2. to improve the home care system from user feedback and recommendations.      Methods: Participants (n = 50) will be recruited from geriatric clinics in National Taiwan     University Hospital (NTUH) main hospital and its Beihu branch. Enrollment criteria include:     aged 60 or older, living alone or with one companion (not children), taking at least one     chronic medications, having the capability to understand the study and complete the study,     willing to participate into the study with telephone follow ups.   "
51114|NCT02616562|"     This trial is conducted globally. The aim of the trial is to investigate efficacy and safety     of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment     (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth     hormone deficiency.      The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension     period and a 104 weeks safety extension trial period.   "
51115|NCT02616549|"     The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention     featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major     Depressive Disorders with incomplete response to antidepressants.   "
51116|NCT02616536|"     Procedures:      The study will be conducted in two phases:      Phase 1        -  Perception and Satisfaction questionnaire will be developed        -  A validation test will be conducted on the Perception and Satisfaction questionnaire          (face, content and construct) before conducting the study. The validation process will          involve the participation of lecturers, professors and students by convenience sampling.      Phase 2        -  To prevent bias from the researchers, each participant will be given their code as their          identification number. Then the participants will be randomly divided into two groups.          They will be briefed on the purpose of study (stating that, the investigators would like          to see the efficacy of various teaching methods on students' knowledge gain) and          procedure of the study (examinations will be conducted, surveys at the end of each class          session and at the end of the study). They are requested to fill up basic demographic          data, consent form and ILS questionnaire(measuring the learning style of student) before          beginning the study.        -  In this study, the lecture will be given by the 'Researcher 1' to standardize the input          to the participants of the two groups. This will produce a standardized input to the          students of the two groups of teaching method.        -  For the FC (flipped classroom) group, the length of the pre-recorded lecture videos will          be the same which the participants can view it unlimitedly. An assignment will be given          for FC group that will be attempted during the discussion class(2 hours) a week after          with the lecturer. No grades will be given for the assignment.        -  Meanwhile for the TC(traditional classroom) group, a standard lecture class of 1 hour          and 1 hour of tutorial class will be conducted on the same topic. The same ungraded          assignment will also be given to this group a week after the lecture class to be          attempted in the tutorial class        -  One day gap will be given following the discussion and tutorial class for FC and TC          groups respectively following which an examination of 1 hour duration will be conducted          to test on their level of knowledge (assessed by exam score) on the topic being taught          for both the groups using the same set of questions.        -  At the end of the study, each participant will be given a feedback questionnaire to          evaluate their perception and satisfaction on the teaching method applied on them using          the 'Perception and Satisfaction Questionnaire'.   "
51117|NCT02616523|"     Using combination of opioid analgesics and analgesics with different mechanism of action the     investigators can decrease the consumption of opioid analgesics and their side effects. The     investigators will use opioid analgesic fentanyl alone or in combination with dexmedetomidine     or lidocaine.The participants scheduled for laparoscopic intestine resection will be divided     in three groups: in the first group, the participants will receive single boluses of     fentanyl, in the second group, the participants will receive continuous infusion of lidocaine     and single boluses of fentanyl, and in the third group, the participants will receive     continuous infusion of dexmedetomidine and single boluses of fentanyl. Participants with     intraoperative infusion od dexmedetomidine or lidocaine will need less boluses of fentanyl     during the operation and less opioid analgesics after the operation in comparison to those     who will receive only fentanyl boluses. Better cognitive function after the operation is     expected in participants receiving dexmedetomidine infusion. There will be minimal incidence     of neuropathic pain because of minimal surgical injury of peripheral nerves in all groups of     patients.   "
51118|NCT02616510|"     The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of     reproductive age. PCOS is associated with various cardiovascular risk factors such as     obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether     these increased cardiovascular risk factors result in the development of actual     cardiovascular disease in later life remains to be established.      Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40     years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously     associated with increased cardiovascular morbidity and mortality.   "
51119|NCT02616497|"     Investigation of the efficacy and safety of triflusal in comparison with aspirin in patients     with stable coronary artery disease (CAD) and in those with a history of an acute     non-cardioembolic ischemic stroke.   "
51404|NCT02612766|"     The purpose of this study is to determine the safety and tolerability of oats in gluten free     diet.   "
84137|NCT02184715|"     The purpose of this study is to investigate the effects of virtual reality system on children     with developmental delays.   "
51120|NCT02616484|"     The objective of this research study is to conduct a pivotal phase 3 trial of treatment with     the investigational drug dichloroacetate (DCA) in young children with deficiency of the     pyruvate dehydrogenase complex (PDC). PDC deficiency (PDCD) is the most common cause of     congenital lactic acidosis and is a frequently fatal metabolic disease of childhood for which     no proven treatment exists. The investigators predict that DCA represents targeted potential     therapy for PDCD because of its ability to increase both the catalytic activity and stability     of the enzyme complex. The conclusions of numerous laboratory and clinical investigations are     consistent with this postulate and have led to the designation of DCA as an Orphan Product     for congenital lactic acidosis by the Food and Drug Administration.      A novel Observer reported outcome (ObsRO) survey that is completed by study participant's     parent/caregiver, is the efficacy outcome measure.   "
51121|NCT02616471|"     The overall aim of the present research project is to examine whether consumption of high     daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a     study population of men and women with metabolic syndrome risk factors.      It will be explored whether high-fat and/or low-fat cheese consumption can be regarded     healthy to consume for at-risk populations (assessed by within-group comparisons from     baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to     be recommended (assessed by between-group comparisons).      In addition, it will be assessed if cheese consumption affects women and men differently as     suggested by observational data. The present research project will examine the health effects     of cheese as a food product per se and not as a sum of single nutrients, knowing that the     single components of cheese cannot be adequately placebo-matched. A relatively high daily     intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a     carbohydrate control.   "
51122|NCT02616458|"     Importance: Ear pain is a frequent reason for pediatric visits. Objective: To determine if a     program of anticipatory guidance counseling for ear pain at the 12-15 month routine     preventive care visit in a predominantly low income population can reduce medical visits to     clinic, emergency department (ED), and urgent care (UC).      Design: Single blind randomized control trial of an ear pain counseling program.      Setting: The Child Health Clinic (CHC), a primary care clinic at Children's Hospital     Colorado, which serves a predominantly low income population with diverse cultural and ethnic     backgrounds.      Participants: 310 mothers were enrolled at their child's 12-15 month well child visit.      Intervention: Structured 10-minute education intervention, given by a research assistant,     used a slide presentation that reviewed ear pain Main Outcome and Measures: Number of ED, UC,     and clinic visits for otitis media for the 12 month period after entry into the study and     whether the visit included a prescription for antibiotics.   "
51123|NCT02616445|"     The purpose of this study is to determine whether the drug UE2343, a potential treatment for     Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics     and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study     will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.   "
51124|NCT02616432|"     A randomized screening trial to compare the diagnostic accuracy of screening for breast     cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional     full-field digital mammography (FFDM) versus FFDM alone.   "
51125|NCT02616419|"     Since the late 1980s, several studies focused on pediatric procedural pain and show that it     still underevaluated and undertreated, especially in the Emergency Department (ED).     Needle-related procedures are the most important source of pain and anxiety and children.     Since it is impossible to completely eliminate the pain and anxiety experienced by children     during painful procedures, use of non-pharmacological and/or pharmacological interventions     might be beneficial. Most methods used for relief of procedural pain and anxiety for children     require time or extra staff, which represent barriers to their implantation in the ED. An     easy-to-use and rapid non-pharmacological intervention could overcome these constraints and     optimize procedural pain and anxiety relief in children undergoing a needle-related     procedure.      The primary objective of this study is to determine if a device combining cold and vibration     (Buzzy®) is non-inferior (no worse) than a topical anesthetic cream (lidocaine liposomal 4%)     for procedural pain management in children undergoing needle-related procedures in the ED.      Investigators strongly believe that the use of the Buzzy® device in the ED will improve     significantly the pain and anxiety felt by children undergoing needle-related procedures.     Since EDs are usually chaotic and very busy, an easy-to-use and rapid non-pharmacological     intervention like the Buzzy®, will surely be adopted by the nursing personnel as a useful     tool for procedural pain. Given this knowledge, the investigators feel that this randomized     controlled trial will have the potential to improve nursing practice and optimize painful     experiences of children undergoing needle-related procedures.   "
51126|NCT02616406|"     This is a study using wearable monitoring devices, patient activity and sleep patterns to     monitor pre and post operative following outpatient inguinal hernia surgery to determine when     these parameters return to baseline.   "
51127|NCT02616393|"     A study to assess the activity of tesevatinib in subjects with NSCLC and activating EGFR     mutations who have disease progression with Brain Metastases (BM) or Leptomeningeal     Metastases (LM) or who heave either BM or LM at initial presentation.   "
51128|NCT02616380|"     The study is designed as a prospective, observational study to assess the effect of     adalimumab on health-related quality of life (QoL) and work productivity in patients with     rheumatoid arthritis (RA) in Taiwan.   "
51129|NCT02616367|"     This is a randomized prospective outcomes study comparing two groups of patients. One group     will receive liposomal bupivacaine for a periarticular injection. The other will receive     ropivacaine for periarticular injection for pain relief after Total Knee Arthroplasty. the     primary objective of this study is to determine if liposomal bupivacaine provides superior     pain control (decreased maximal pain scores within the first 72 hours post surgery) when     compared to ropivacaine when injected in a periarticular injection.   "
51130|NCT02616354|"     Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with     severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical     rational use of antimicrobial agents, and provide theoretical support for optimizing dosage     regimen.   "
51415|NCT02612623|"     This is an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant     (AF-219) in subjects with refractory chronic cough.   "
51131|NCT02616341|"     The overall aim of this study is to determine modifications to Exposure and Response     Prevention (ERP) therapy that are needed in order to effectively deliver treatment for     Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the     final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP)     intervention that will optimize therapist time by utilizing paraprofessionals to assist with     group-ERP treatment plans. The intervention will be tailored to meet the unique needs of     low-SES individuals with OCD and be implemented in a community mental health center (CMHC).   "
51132|NCT02616328|"     This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy     and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical     practice.   "
51133|NCT02616315|"     The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and     bupropion hydrochloride extended release combination (NB) compared with placebo on weight     loss in obese participants post bariatric surgery.   "
51134|NCT02616302|"     The purpose of this study is to assess the safety and effectiveness of treatment with once     daily (QD) oral administration of dexlansoprazole capsules (15, 30, and 60 mg) in pediatric     participants aged 1 to 11 years with symptomatic nonerosive gastroesophageal reflux disease     (GERD).   "
51135|NCT02616289|"     The investigators hypothesize that the absorption of topically applied EFA-containing     emollient (SSO) into the skin and thence into the bloodstream in children with SAM will     improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond     that possible through normal standard-of-care   "
52029|NCT02604537|"     The purpose of this study is to determine if corticosteriod injection modifies the natural     course of de Quervain tendinopathy compared to a toradol injection.   "
51136|NCT02616276|"     This is a crossover clinical trial aimed at adults (aged 20-40 years, with no cardiovascular     disease), selected by consecutive sampling at urban primary care health clinics in Salamanca     (Spain). Each subject will complete three interventions, with a washout period of one week:     control breakfast (water), low glycemic index breakfast (apple, yogurt, walnuts and black     chocolate) and high glycemic index breakfast (grape juice, bread and strawberry jam). The     postprandial effect will be assessed at 60 and 120 minutes from each breakfast, measuring     blood glucose and insulin and cognitive performance. Measurements will be performed of     central blood pressure, augmentation index, pulse wave velocity, cardiac output and total     peripheral vascular resistance at minutes (-10, 0, +15, +30, +45, +60, +75, +90, +105 and     +120).   "
51137|NCT02616263|"     The purpose of this research study is to determine the relationships between foot muscle,     foot motion, and toe deformity. Results from this investigation will help the investigators     to understand what contributes to foot deformities and the role of the foot muscles in the     development of foot deformities. This could potentially guide treatment options focusing on     strengthening the foot muscles to prevent or reduce the risk of developing a foot deformity.   "
51138|NCT02616250|"     The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM)     associated with Brimonidine 0.33% gel (Br) compared with the association of their respective     vehicles in the treatment of moderate to severe rosacea.   "
51139|NCT02616237|"     The purpose of this study is to determine the feasibility and efficacy of a 6-month weight     loss intervention program for obese working adults through a popular social networking site -     Facebook.   "
51140|NCT02616224|"     This observational disease registry is a prospective, national, non-interventional study     designed to enroll participants who have received an initial diagnosis of unresectable,     locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry     enrolment. These participants will be prospectively followed for at least 5 years after study     enrolment to evaluate their anti-cancer treatments. Data on participants' previous     anti-cancer treatments for breast cancer will be collected retrospectively at study entry.   "
51141|NCT02616211|"     Patients are asked to participate in this study if they have been diagnosed with a thoracic     carcinoma which includes lung cancer and have a gene mutation (alteration in the body's     genetic instructions) and after undergoing treatment the cancer has come back, progressed, or     shown a partial response on standard treatment.   "
51142|NCT02616198|"     The aim of this study was to evaluate the long-term clinical performance of two highly     viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia     Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS)     criteria.      A total of 256 restorations were made with EquiaFil and Riva SC. Equia Coat or Fuji Varnish     was used randomly on the surface of the restorations. The restorations were evaluated at     baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. The     results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p< 0.05).   "
51143|NCT02616185|"     The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses     of a vaccine-based immunotherapy regimen for patients with prostate cancer.   "
51144|NCT02616172|"     Autologous human bone marrow mononuclear fraction (BMMF) will be harvested and given to     children with bilateral moderate to severe sensorineural hearing loss. The aim is to     determine if bone marrow mononuclear fraction (BMMF) infusion is safe, feasible, improves     inner ear function, audition, and language development.   "
51145|NCT02616159|"     The objectives of this study are to compare the glycemic and insulinemic responses over 3     hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat     and hot cereals.   "
51146|NCT02616146|"     The purpose of this study is to assess the contraceptive efficacy of the ENG-E2 vaginal ring     in women between 18 and 35 years of age based on the number of in-treatment pregnancies as     expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of     ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 μg combined oral     contraceptive (COC) will be used as the active comparator.   "
51147|NCT02616133|"     Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated     by a medical oncologist for neo-adjuvant treatment due to the current lack of care     coordination between the surgeon/surgical oncologist and the medical oncologists.      This project will evaluate the feasibility to enhance knowledge that drives adoption of     evidence based care, and evaluate the improvement in care coordination between oncologists     and surgeons for patients with HER2+ Breast Cancer in the Neo-Adjuvant setting.   "
51148|NCT02616120|"     The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on     non-motor symptoms of PD patients.   "
51149|NCT02616107|"     The purpose of this two-year mixed methods study is to develop and test an intervention to     improve cancer family caregivers' knowledge of care options (curative, palliative, and     hospice care) and goals of care communication as part of a self-management (SM) training     program.      The two specific aims of this project are to:        1. Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's          Guide (MCC-CG), for family caregivers of patients with breast cancer to increase          knowledge of care options, goals of care communication, and other SM skills.        2. Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized          controlled trial compared with an attention-control condition (symptom management          education) on knowledge of care options, goals of care communication, and other key SM          skills (engagement in SM, management of transitions and uncertainty, increasing          self-efficacy, appropriate use of health care resources).   "
51150|NCT02616094|"     Extending previous findings, and applying a novel multi-method translational approach, this     project hypothesizes that there are alcohol-related neuroendocrine and neural changes     observable in acute and protracted abstinence, and which can accurately classify future     relapse and treatment outcome in separate alcohol dependent (AD) patient samples, thereby     validating them as biomarkers of relapse, with potential clinical utility as prognostic     markers in identifying and treating those most susceptible to relapse.   "
51151|NCT02616081|"     The investigators goal is to create a better understanding of patient reported outcomes for     bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter     (IDC) and bladder surgery.   "
51153|NCT02616055|"     Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment     will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101     study.   "
51154|NCT02616042|"     This study aims to evaluate the effect of dentifrice formulations containing Centella     asiatica and bamboo salt on gingivitis and dental plaque. Participants uses dentifrice which     contains Centella asiatica and bamboo salt and the same participants will also use placebo     for tooth brushing by cross-over design.   "
51156|NCT02616016|"     The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity     and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No     serious adverse effects are expected to result from this treatment.   "
51157|NCT02616003|"     The frequency of patients with a BMI above 70 kg/m2 who need immediate weight loss surgery is     risen continuously. For those patients a prior-to-surgery conditioning therapy is mandatory     to gain technical and physical operability. The exclusively well-established preliminary     therapy so far was the intragastric balloon, which takes 7 months of treatment time. Due to     life-threatening conditions of giant obese patients, who have been admitted to hospital, the     investigators were forced to develop a more prompt acting conditioning therapy to bring those     individuals in a short run to an improved and fit-for-surgery state. In such an impasse the     investigators combine Liraglutide with its well-known weight-loss effect with a leucine-based     amino acid infusion that is generally used for patients with liver insufficiency, in     expectance of an additional weight loss and liver reduction effect.   "
51158|NCT02615990|"     This study will assess the effects of the Erigo applied as part of the early mobilization     program in the Trauma ICU at the University of Kentucky. It is our hypothesis, that with the     Erigo, critically ill patients will tolerate verticalization and mobilization earlier and     safely resulting in improved outcomes measured by increased mobility and strength on ICU     discharge, decreased requirements for mechanical ventilation, reduced complication rates and     decreased ICU and hospital LOS.   "
51159|NCT02615977|"     The investigators will examine clinical alterations in learning and automated approach     behaviour and their neurobiological correlates in alcohol-dependent patients and healthy     social drinkers and assess whether they are affected by a Zooming Joystick Training (ZJT;     randomized verum versus placebo training) which trains subjects to habitually push     alcohol pictures away.      The investigators will test whether activations following treatment predict relapse rate     (primary outcome measure) and the prospective amount of alcohol intake (secondary outcome     measure) within a six-month follow-up period.      Using fMRI, the investigators will use the Pavlovian-to-Instrumental-Transfer (PIT) paradigm     established during the first funding period to distinguish the effects of appetitive,     aversive, and drug-related Pavlovian cues on automated instrumental approach behaviour and to     assess ZJT training effects comparing functional activation before and after ZJT training.      The investigators will also scan subjects during performance of a short standard working     memory task. Behaviourally, aspects of impulsivity will be assessed with the Value-Based     Decision Making (VBDM) Battery. Scanning will be repeated after ZJT training to assess its     effects on the neural correlates of Pavlovian-to-Instrumental transfer (PIT).   "
51160|NCT02615964|"     Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will     be asked to participate. 10 hands of patients with both Raynaud's disorder and scleroderma     will be studied. This research study is being done to better understand Raynaud's disease and     to assess the role of blood flow measurement in diagnosing the disorder, specifically,     through data collected by an MRI procedure called NOVA FLOW. NOVA is a blood flow measurement     software system owned by the study's sponsor, VasSol, Inc.   "
51183|NCT02615665|"     The long-term outcome of patients resected for colorectal liver metastases (CLM) after     neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as     the immune response to the tumor and to the CHT. The aim of this study was to investigate the     impact of the pathological and immunological response in patients undergoing liver resection     for CLM after CHT in regards to the long-term outcome.   "
51161|NCT02615951|"     Recently, it has been shown that B cells could also have regulatory functions through the     secretion of interleukin 10 (IL-10). They are called the B regulatory cells (Breg). In the     mouse model the most commonly used of rheumatoid arthritis, collagen-induced arthritis (CIA),     the transfer Breg helps prevent the development of CIA and cure established arthritis. The     investigators have recently shown that Breg were decreased in patients with RA compared to     controls and that the rate of Breg was inversely correlated with disease activity and     autoantibody. These results thus suggest that the lack of IL-10 secretion by B cells plays an     important role in the pathophysiology of RA. Nevertheless, in humans, the Breg remain poorly     understood. The main objective of this project is to better characterize the B capable of     producing IL-10 both in subjects with RA and controls. Understanding which induces the     secretion of IL-10 by B could allow to consider new therapeutic approaches in autoimmune     diseases, including in RA.      The investigators therefore aim to identify nutrient transporters, chemokine receptors, genes     and surface proteins differentially expressed between Breg and other B cells in patients with     RA and in controls.   "
51162|NCT02615938|"     This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled,     parallel-group, multinational study investigating the initiation or withdrawal of     hydroxychloroquine in subjects with chILD.   "
51163|NCT02615925|"     Provide a description of patients admitted in the psychaitric department of the Mayotte     Hospital   "
51164|NCT02615912|"     The purpose of this study is to understand the changes in skin microflora, skin barrier     function, and skin biochemical constituents in response to direct contact with model     surfactants used in personal care articles. The results from this study will provide insights     into the complex interaction between the skin microbiome and the epidermis after exposure to     surfactants.   "
51253|NCT02614937|"     This was a prospective, single center, open label, randomized study evaluating the biological     effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous     ranibizumab in patients with macular edema secondary to branch, hemi-central and central     retinal vein occlusion (BRVO, HRVO, CRVO).   "
51254|NCT02614924|"     The purpose of this study is to identify whether Pentax Airway Scope (AWS) videolaryngoscope     would be a more effective device compared to flexible fibreoptic scope (FOS) for awake     intubation in a difficult airway.   "
51165|NCT02615899|"     Background Balance impairment is a key factor contributing to falls in older adults.     Conceptually, clinicians may be able to prescribe targeted exercises if specific impairments     can be identified. Objective Our objective was to use a model of balance subsystems to     identify balance impairments and demonstrate the effectiveness of targeted (matched)     exercises to improve balance and reduce fall risk in community-dwelling older adults. The     investigators used the Balance Evaluation System Test (BESTest) as the model because it     categorizes balance into 6 subsystems. Design Randomized, partially blinded,     pretest-post-test clinical trial consisting of 2 Phases: 1. A comparison between     impairment-matched exercises and a control, and 2. A comparison between impairment-matched     and mismatched exercises. Setting Senior independent living community. Participants Adult     volunteers (n = 40; aged 74-94) recruited as sample of convenience who met the criteria.     Participants (n = 20) identified with impairment in the biomechanical (BC) constraints     subsystem and participants (n = 20) with impairment in anticipatory postural adjustment (APA)     subsystem were enrolled and randomized into 2 subgroups (matched and control/delayed     mismatched; n = 10 each subgroup). Intervention Phase 1: Participants in the matched subgroup     received a 6-week exercise program matched to their impaired subsystem while the mismatched     subgroup served as control. Phase 2: Following the delay, participants in the mismatched     group received a 6-week exercise program mismatched to their impairment. Measurements Primary     outcome variables were scores on the targeted subsystem (BC, APA), BESTest total, Berg     Balance Scale, and fear of falling measure. Quality of life was a secondary outcome. Outcome     data were collected by the tester blind to pretest scores and group allocation. Results The     matched exercise subgroups demonstrated both statistical and clinical improvement in all     outcome variables compared to the control; and showed greater improvement in balance     impairments compared to the mismatched subgroup, but not in fall risk reduction. Limitations     The therapist who administered the pretest knew the subgroup assignment and implemented the     exercises. Conclusions Results provide preliminary evidence that using a balance assessment     model to identify impairments in the BC and APA subsystems and prescribing targeted exercises     reduces these balance impairments for older adults and may warrant future studies.   "
51166|NCT02615886|"     The purpose is to assess feasibility of rice bran consumption in weaning children and collect     pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal     prevention.   "
51167|NCT02615873|"     The purpose of this study is to allow evaluation of long-term clinical effect and safety     outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended     treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core     study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind,     double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD     versus IR CD/LD in fluctuating PD patients).   "
51168|NCT02615860|"     Comparative evaluation of efficacy and safety of high-resolution anoscopy (HRA)-guided     topical treatment (trichloroacetic acid, TCA) vs. surgical treatment (electrocautery, ECA) in     HIV-positive patients for human papillomavirus (HPV)- induced AIN, an anal cancer precursor.     The primary hypothesis is that cost-saving and simple TCA treatment is non-inferior to the     current best option therapy with ECA. TCA treatment would also be possible in the normal     setting of a doctor´s office without extensive specialization and without complex technical     equipment.   "
51169|NCT02615847|"     Symptomatic sickle cell disease is worldwide the most frequent cause for hereditary hemolytic     anemia with recurrent pain crisis. Hemolysis, vaso- occlusive and pain crises are hallmarks     of this disease and are causative for an important socio-economic burden worldwide,     especially in Africa.      Aside from allogenic stem cell transplantation, which is rarely available and very expensive,     at present there is no curative treatment for patients with sickle cell disease (SCD). The     current standard of care includes treatment with hydroxycarbamide and symptomatic care such     as transfusions, antibiotic/analgesic treatment.      This study has the aim to study the safety and tolerability of Memantin in patients with     sickle cell disease.   "
51170|NCT02615834|"     We previously showed that a gentle chest pressure technique could be used on children over a     year old to generate around 20% of the volume of air inhaled or exhaled in a single normal     breath (also known as tidal volume). This showed that a non-invasive method could be used to     provide a temporary means of artificial breathing, meaning that invasive procedures, such as     putting in a breathing tube, could be avoided. What our results did not tell us, however, is     how much oxygen can get to peripheral tissues (e.g., arms, legs) with this method. In this     study, we want to compare two groups of children. All children will have a breathing tube;     one group will have gentle chest pressure performed on them to see if oxygen saturations can     be maintained above 90%. The other group will receive no chest pressure. We will see how long     it takes for oxygen levels in both groups to drop to 90%, at which point, the patient will be     ventilated mechanically.   "
51217|NCT02615418|"     This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for     treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind     sham controlled partial crossover design and will involve 2 weekly treatments and evaluations     for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change     immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life     improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes     or lack thereof in treated and untreated subjects.   "
51171|NCT02615821|"     Given the numerous physical and psychological benefits of engaging in regular physical     activity (Biddle & Ekkekakis, 2005; Warburton et al., 2007) and the decrease in students'     physical activity levels during the transition from high school to university (Bray & Born,     2010) it is important for researchers to develop time-and-cost-effective interventions to     prevent this drop in physical activity. Intervention research shows mental contrasting (a     goal setting strategy) can be taught in a cost-and-time-effective way in order to increase     physical activity (Oettingen, 2012). Researchers have also found that individuals who     consider the emotional effects of physical activity are more likely to be physically active     than those who consider the health-related effects (Rhodes et al., 2009). The purpose of this     research is to combine these two approaches to develop and evaluate a novel mental     contrasting intervention to increase physical activity among a sample of undergraduate     students.   "
51185|NCT02615639|"     The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who     have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in     Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific     cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in     CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the     body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper     cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB     patients who have been on anti-HBV drugs but with poor effects, supposing to significantly     improve anti-HBV efficacy, even to clean HBV from the patients.   "
51186|NCT02615626|"     The purpose of this study was to evaluate visfatin levels in different stages of periodontal     diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin     levels in Gingival Crevicular Fluid (GCF) and Serum.   "
51172|NCT02615808|"     Hospitalized children with respiratory disease are commonly monitored with continuous pulse     oximetry and heart rate-respiratory rate monitors. These data streams generate >4,000 unique     data points each patient-day, yet only a tiny fraction are used to inform care decisions.     Failure to adequately summarize this large amount of data for clinicians may result in     suboptimal care because clinicians may miss important data signals and may under- or     over-react to individual data points. In children hospitalized with respiratory disease and     in need of supplemental oxygen, there are a number of care decisions, currently made without     adequate data, which could be informed by intelligent data visualization tools. This study     has employed user-centered design to develop data displays that inform nurses' and     respiratory therapists' decision-making in supplemental oxygen delivery. The investigators     are now evaluating the effectiveness of these displays in the clinical care of patients with     two common respiratory conditions—infants with bronchiolitis admitted to the general     pediatrics ward and preterm infants requiring supplemental oxygen who are cared for in the     neonatal intensive care unit. By reducing patient's time on supplemental oxygen and improving     time with optimal oxygen saturations, this work has the potential to lead to a breakthrough     innovation that improves both outcomes and value.   "
51173|NCT02615795|"     The aim of this study is to evaluate the effect of monitoring patients with chronic     obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or     pneumonia. The patients are randomized to receive either standard treatment and follow up, or     standard treatment and follow up, plus tele monitoring of key clinical parameters and     symptoms for six months.   "
51174|NCT02615782|"     This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial     to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in     healthy male subjects   "
51175|NCT02615769|"     The purpose of this study is to investigate if focused information of spirometry in the     invitation to preventive health checks will increase the attendance compared with a standard     invitation to preventive health checks.   "
51176|NCT02615756|"     In this study, we use positron emission tomography (PET) and functional magnetic resonance     imaging (fMRI) to study brain mechanisms that contribute to physical exercise-induced reward.     We examine whether acute physical exercise releases endogenous opioids in the brain, and     whether it modulates brain responses to viewing appetizing foods. Unraveling these mechanism     are instrumental from a public health perspective, given the undisputed positive health     effects of physical exercise.   "
51177|NCT02615743|"     This study sets out to assess whether daily text message reminders help to enhance the     consistency of use of controller medications following hospitalization for pediatric asthma     patients ages 4-11 and their families. Text message reminders will be delivered to a     subject's cell phone for those in the intervention group and electronic monitors will placed     on the controller inhalers at the time of hospital discharge to track medication use over     time in both the intervention and the regular care group. Families will complete surveys on     the day of enrollment (in person), day 30 (telephone) and day 60 (telephone) on aspects of     asthma care including asthma knowledge, medication routines, who is responsible for asthma     care, and medication beliefs.   "
51178|NCT02615730|"     This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to     evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral     GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject     populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will     be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose     Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the     recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel.     The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity     of the RP2D as determined in the Dose Escalation Phase.   "
51179|NCT02615717|"     Threat-related attentional biases have been identified as a possible precursor to the onset     and maintenance of posttraumatic stress disorder (PTSD). As a result, protocols such as     Attention Bias Modification (ABM) have been developed and utilized to treat these attentional     biases in adults diagnosed with PTSD. However, to-date, ABM protocols have not been examined     for use specifically among victims of sexual assaults. Participants are 20 undergraduate     women enrolled in a Midwest university. The efficacy of ABM in this population will be     assessed, as will the relationship between ABM and PTSD symptom clusters and outcome     variables such as anxiety and depression scores.   "
51180|NCT02615704|"     An electronic device application (APP) Mein Herz und ich has been developed specifically     for acute coronary syndrome (ACS) patients who are prescribed to Brilique (ticagrelor) to     increase adherence to treatment (medication and lifestyle changes) by a combination of     reminders on medication intake, information on the importance of treatment, motivation by     supportive messages, and visualisation of individual lifestyle choices' effect on     cardiovascular risk. The aim of this study is to evaluate the effectiveness of this patient     support tool.   "
51181|NCT02615691|"     The purpose of this study is to investigate safety, immunogenicity and hemostatic efficacy of     PEGylated recombinant FVIII (BAX 855) in previously untreated (PUPs) and minimally treated     patients (MTPs) with ≤ 3 EDs to ADVATE or BAX 855 < 6 years of age with severe hemophilia A     (baseline FVIII level < 1%)   "
51182|NCT02615678|"     The aim of this study is to collect preliminary data on the effectiveness of acupuncture for     the treatment of CIPN in breast cancer patients.   "
51184|NCT02615652|"     Researchers of the three collaborating universities implement a pilot observational study in     Gilgel Gibe Field Research Center, a health and demographic surveillance system run by the     Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in     young men for the development of common mental disorders and psychotic symptoms and the     stability of distinct symptoms of mental disorders in the community. The investigators will     explore in particular the impact of lifestyle on mental health in young men, including the     traditional habit of chewing khat leaves, which contain amphetamine-like cathinone.     Furthermore, the investigators want to demonstrate the reliability and validity of     assessments performed by trained local interviewers.   "
51271|NCT02614703|"     Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose a     study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in detecting     neoplasia.   "
51187|NCT02615613|"     30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food     preferences using a questionnaire with 141 different foods. Accordingly, a high     acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic     scale). Two versions of the selected high palatability food will be devised by modifying it     to yield the original high and the modified low acceptability versions. The two versions will     differ only in palatability and will be equicaloric. Subjects who agree on the acceptability     of the two versions of the food (11 subjects) will consume, at fasting, the two versions of     the food in a cross over design over two sessions. Each session will include an acceptability     test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating     the whole portion and after 240 min. The quantity consumed on each session will constitute     30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger     ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240     min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.   "
51188|NCT02615600|"     Stimulation of the left and right auditory cortex with daily low-frequency transcranial     random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic     tinnitus.   "
51189|NCT02615587|"     The overall goal of this retrospective registry study is to investigate the burden-of.illness     in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect     information on the diseases epidemiology including incidence and prevalence of AF and stroke     as well as a stroke risk stratification of the Danish AF-population, the clinical and     economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients,     healthcare providers / healthcare system and society as well as describing treatment patterns     with anticoagulant agents and their consequences in terms of stroke, bleeds, death and     according cost in a real-life setting.   "
51190|NCT02615574|"     The investigators hypothesize that the treatment of metastatic colorectal cancer (mCRC)     patients with the combination of alpha-type-1-polarized dendritic cell (αDC1) vaccines and     tumor-selective chemokine modulation (CKM) will promote the infiltration of     vaccination-induced CD8+ CTLs to tumor lesions and subsequently tumor regression with     improved patient survival.   "
51191|NCT02615561|"     1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch          Relief Cream).        2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially          available cosmetic product   "
51192|NCT02615548|"     Physical activity is a key intervention used to reduce the healthcare costs and the negative     consequences of Parkinson Disease (PD) by improving walking and balance and reducing the     number of falls. However, not all exercise classes provide the same results for people with     PD. Specific exercises designed to target the features of PD have shown greater outcomes than     generic physical activity. The exercise principles include high-intensity (size and speed)     movement, task repetition, rhythmical rocking, mental imagery, cognitive strategies,     treadmill walking, and making use of internal and external cues. Collectively these     PD-specific exercises can be designed to be run in exercise groups. Structured exercise     groups also include social interaction that is known to improve depression and apathy, both     of which are features common in people with PD.      This study will compare the effect of specific, long-term community-based exercise class on     balance, walking, quality of life, and mood compare to self-directed exercise.      Investigators anticipate that participants from the community-based, long-term intervention     will show better improvements in balance and walking compare to participants that are     self-directing their activities.   "
51193|NCT02615535|"     Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness     of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in     cultivating a relaxed, attentive state of mind during meditation. The investigators study     aims to evaluate whether such a tool could be useful in treating persistent traumatic brain     injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.   "
51194|NCT02615522|"     Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing     the CE-mark.      200 subjects will be recruited and followed up for up to ten years or until revision of the     primary knee endoprosthesis, whichever occurs first. Documentation of clinical and     radiological parameters within the clinical routine pre-operative and post-operative at 3 and     12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee     functionality, mobility and stability.   "
51195|NCT02614456|"     This is a phase I study of combination immunotherapy with IFN-γ and the PD-1 inhibitor     nivolumab in patients with advanced solid tumors who have progressed on at least one prior     systemic therapy, which may include prior immunotherapy.   "
51196|NCT02614443|"     The aims of this study are to test the effectiveness and acceptability of internet-delivered     treatment for depression, anxiety and stress in university students. These data will inform     the methods for a future randomized controlled trial.      The trial will establish an initial estimate of the effectiveness of these online     interventions for students in terms of within-group effect sizes associated with changes in     depression, anxiety and stress from pre to post-intervention and follow-up. These data will     be used to estimate the sample size for a future trial to ensure that the study is     sufficiently powered. A conservative estimate using the 90% upper confidence limit will be     used to inform the sample size calculation of the definitive RCT.      Acceptability of the intervention to participants will be assessed using data on usage and     engagement with the intervention (e.g. percentage of participants completing each module,     average number of log ins, average time spent per session and total time spent on the     program). These data are acquired through the online SilverCloud system. Satisfaction with     will be assessed through the use of a post-intervention questionnaire on satisfaction with     accessing and using an online delivery format for treatment.   "
51238|NCT02615145|"     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without     Dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)     has been shown to be safe and effective in randomized controlled clinical trials with strict     inclusion and exclusion criteria under well controlled conditions.      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±     RBV, used according to local label, under real world conditions in Germany in a clinical     practice patient population.   "
59908|NCT02501408|"     Evaluate a new porosthetic device in lower limb amputees.   "
51197|NCT02614430|"     The project will investigate levels of physical, psychosocial functions and inflammatory     biomarkers in a group of patients who by self-assessment indicates a perceived risk of     decline in work ability after hospital admittance. The patients will be randomised to an     intervention of physical training and followed for development in functional levels compared     with patients not receiving the intervention. The goal is to validate measures of work     ability assessment in connection to hospital admittance. The validation will provide     important information about the quality of rehabilitation services that many municipalities     provides through private suppliers - and where the effect on work ability lacks     evidence-based documentation.      The project aims to link patient treatment to recovery and an optimal return to everyday     life, comprising the patients work life. The frame is a multi-sectoral accepted platform for     assessing patients' needs for care, treatment and rehabilitation, which is based on a     professional assessment of the efficacy and quality of, varies heath care related deliveries.     The acceptance of a multi-sectoral creates a need for accessible clinical tests of physical     and mental functioning, combined with biomarkers to identify patients need.      The project investigates whether it is possible to identify patients (age 18 to 60 year) with     an increased risk of losing their ability to work after discharge from an acute     hospitalisation. And to evaluate whether measurable effects on inflammation and functional     levels of labour oriented training program can be identified.   "
51198|NCT02614417|"     Sleep-disordered breathing (SDB) is a wellknown comorbidity in cardiovascular disease.     Knowledge about SDB in adult congenital heart disease is limited.   "
51199|NCT02614404|"     The purpose of this study is to determine the efficacy and safety of imatinib in the     treatment uncomplicated P. falciparum malaria.   "
51200|NCT02614391|"     Venipuncture is one of the painful procedures most frequently performed in children. Pain and     distress management in children, during needle related procedures, is warranted.      The base for pain management starts with behavioural and environmental support and     distraction. Distraction is a cognitive strategy trying to divert the child's attention from     a noxious stimulus. Active distraction involves the child in a different performance, e.g.     playing, during pain procedures. Passive distraction redirects the child's attention to     visual or auditory stimuli using toys, songs, movies or blowing bubbles.      Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a     limited time. Patients usually arrive without a pharmacological premedication and go away     immediately after procedure. In this context distraction is an excellent pain relief tool.      The aim of the study is to compare the effectiveness of an active distraction (playing a     videogame using a computer tablet) with a passive distraction technique in pain relief during     venipuncture in a blood-drawing centre.   "
51201|NCT02614378|"     Evaluate the effectiveness of air insufflation in aborting (stopping) an acute episode of     migraine and compare it with a placebo effect of using the same procedure but without active     insufflation. The insufflation will be used when the subject is experiencing an acute episode     of migraine to determine its ability to reduce, if not to completely eliminate the migraine     symptoms. Subjects receiving the placebo treatment will be offered the active treatment     during the subsequent episode of migraine.   "
51202|NCT02614365|"     Whereas the advantageous effects of exercise-training on memory is increasingly recognized,     the practicality and clinical usefulness of such interventions in community-dwelling older     African Americans (AA)s Mild Cognitively Impaired (MCI) subjects, and the mechanism by which     an effect occurs need elucidation. Because aerobic-exercise can improve emerging     cardiovascular (CVD)-related risk factors for cognitive decline such as lipids, inflammatory     cytokines and glucose homeostasis; the Investigators will examine training effects on these     and related biomarkers. The imperative for this study is further underscored by the fact     that, AAs: i) have high rates of dementia, and ii) have paucity of cross-sectional, and lack     prospective data on the effects of exercise on cognition. To overcome barriers to recruitment     and retention, enhance compliance with a long exercise program (3-times/week), and maximize     the use of available resources, the Investigators will use a community-based approach.     Therefore, the primary objectives of this study build on the Investigators' experience, and     will compare the effects of aerobic-exercise to stretch-exercise (control) in     community-dwelling AA MCI subjects. Following the initial 6 months active intervention, the     aerobic-exercise group will follow a prescribed but free living 40 minutes, 3 time/week     exercise regimen while the control group returns to usual care plus stretch-exercise for     additional 12 months. This study will facilitate the estimation of sample size for a larger     confirmatory study in AAs. A newly acquired direct oversight of the DC Ward-6 Senior Wellness     Center and its infrastructures by the Howard University Division of Geriatrics will provide     additional resources and access to the community. In addition to the Investigator's     feasibility aims, the Investigators will determine performance on cognitive tasks using the     Alzheimer's Disease Assessment Scale-Cognitive Sub-scale (ADAS-Cog) and Clinical Dementia     Rating Scale (CDR) sum of boxes supplemented by tests of executive function (EF) and     Functional Activity Questionnaire (FA) and together as ADAS-Cog-Plus; changes in brain volume     regions of interest (ROI) with Magnetic Resonance Imaging (MRI), selected CVD and AD-related     bio-markers.   "
51203|NCT02614352|"     Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and     Atorvastatin 40mg in healthy male subjects.   "
51204|NCT02614339|"     The aim of this study is to identify the effect of adjunctive metformin on recurrence of     non-DM stage III colorectal cancer. This study is open-label randomized controlled study.      The primary endpoint is to compare the 3-year disease free survival between metformin group     and non-metformin group. The secondary endpoint is to compare the 5-year overall survival and     disease specific survival between two group, to identify the safety of metformin, and to     compare the recurrence rate of polyps after polypectomy between two groups.   "
51205|NCT02614326|"     A wealth of research has demonstrated that they way in which the investigators recall our     personal, autobiographical memories is influential in the course of depression. Biases in the     recall of autobiographical memory occur in the midst of a depressive episode, and are shown     to prolong symptoms, however these biases also remain when depression remits, and may     predispose the individual towards relapse. A novel cognitive intervention, MemFlex, aims to     train individuals to be flexible in their retrieval of autobiographical memories, and thereby     reduce depressive relapse. Changes in memory bias may also have an effect on intermediate     processes that increase risk of depression, such as rumination, impaired problem solving, and     cognitive avoidance. This feasibility trial compares the effects of MemFlex and     Psychoeducation in their ability to reduce memory bias and intermediate cognitive risk     factors, and thereby depressive relapse, in individuals remitted from Major Depressive     Disorder. Clinical outcome and process measures will be assessed immediately following     completion of the intervention, at 6 months post-intervention, and at 12 months     post-intervention. If encouraging, the results of this pilot trial may provide a foundation     for a later phase trial.   "
91382|NCT02089971|"     To describe the normal range of muscle mass and function in Chinese adults.   "
51206|NCT02614313|"     Background: Breath testing for food intolerances is becoming routine in patients with     functional gastrointestinal disorders (FGID). Both FGID and saccharide intolerances (FODMAPs:     fermentable oligo-, di-, polysaccharide and polyols, e.g. lactose, fructose, sorbitol) are     common (>10% of any given population) and often respond to dietary modification. The breath     tests are based on quantification of gas excretion in breath as a sign of malabsorption and     symptom provocation, but are likely subject to considerable psychological bias. The role of     expectation and other psychological effects on breath testing has not been reported, but is     crucial for the validation of these increasingly wide-spread tests with considerable dietary     and potentially deleterious consequences. Fructose has been shown to result in short term     pro-inflammatory metabolic responses, but these effects have not been studied as underlying     causes for intolerance symptoms in fructose intolerant patients with FGID.      Aim: To investigate the psychological component and the short-term metabolic effects of     fructose breath testing in patients referred for evaluation of FGID using placebo.     Additionally, to assess baseline predictors for a positive breath test result.      Methods: Fructose intolerance (defined by a positive symptom index) and malabsorption     (defined by increased breath hydrogen/methane concentrations) will be determined in 30     successive male and female FGID in a single centre using breath-testing. Fructose 35g, given     double-blind as well as open, a sweet placebo (cyclamate/saccharine; Assugrin®) and a neutral     (still water) placebo given double-blind will be compared in a randomized, cross-over     sequence and according to our standardised procedure on four separate study days. Symptoms     will be recorded using standardised questionnaires and breath concentrations of H2 and CH4     will be measured during testing on the four study days. Somatisation and psychological     profiles will be assessed by questionnaires. Blood samples will be obtained before and during     provocation testing to assess short-term responses to fructose loading by metabolomics.     Fructose, blinded and open, and placebo responses will be compared and baseline predictors     for a positive breath tests assessed.   "
51207|NCT02614300|"     Pulmonary rehabilitation programs are part of the multidisciplinary treatment of some chronic     respiratory diseases such as COPD (chronic obstructive pulmonary disease). Although clinical     guidelines of other diseases such as non-cystic fibrosis bronchiectasis (nCFBE) discuss the     benefits of these programs in quality of life and exercise tolerance, evidence of such     intervention in nCFBE patients is insufficient. Longer studies are needed with larger sample     sizes and optimized to maximize the response and maintain long-term benefits. The present     study aims to examine the effects in exercise tolerance of a pulmonary rehabilitation program     combined with respiratory physiotherapy in patients with nCFBE. It is a randomized controlled     clinical trial with a total duration of 24 months. The intervention will be performed during     12 weeks and then will be a period of 12 months of maintenance. This is a multicenter study     involving the following Hospitals: Hospital Clinic, Hospital la Plató and Hospital del Mar of     Barcelona, Hospital Josep Trueta of Girona, Royal Infirmary of Edinburgh and Fondazione     Maugeri di Lumezzane of Italy. Subjects will be randomized into three groups in a ratio (1:     1: 1) (1) Pulmonary Rehabilitation (2) Chest Physiotherapy and (3) Pulmonary Rehabilitation +     Chest Physiotherapy. Hospital la Plató from Barcelona will be responsible for carrying out     the Control Group. The primary endpoint will be the test of endurance shuttle walk test.   "
51208|NCT02614287|"     The main purpose of this study is to evaluate the longer term safety of the study drug known     as LY2951742 in participants with episodic or chronic migraine.   "
51209|NCT02614274|"     The Nutramax test article is a nutritional supplement that contains several ingredients shown     to potentially provide benefit to patients suffering from a painful and sometimes     debilitating condition of the knee called osteoarthritis.      This is a pilot study that is intended to determine whether results from a proprietary     testing panel conducted on blood and urine samples will correlate with data from physical     examination and validated surveys that measure participants' quality of life and physical     capabilities.   "
51210|NCT02614261|"     The main purpose of this study is to evaluate the efficacy of the study drug known as     LY2951742 in participants with chronic migraine.   "
51211|NCT02615496|"     The study will be an observational, cross-sectional study of knowledge, understanding, and     self-reported behavior among a sample of physicians and patients with recent aflibercept     experience in a total of up to five European countries.   "
51212|NCT02615483|"     The purpose of the present study is to investigate the effect of a Web- based Platform (WP)     on anxiety and depression and health economics among patients undergoing lumbar spine fusion     (LSF).   "
51213|NCT02615470|"     The study's aim is to enhance current immunization activities in community pharmacies through     targeting the two most commonly available non-seasonal vaccines in community pharmacies,     namely pneumococcal and herpes zoster vaccination services. The study will compare the change     in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from     the corresponding 6-month period prior to the intervention to the 6-month intervention period     between intervention pharmacies and the control pharmacies.   "
51214|NCT02615457|"     RATIONALE:      Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely     used in China for many years. The investigators previous study has reported that Huaier could     exert great inhibitory effects on breast cancer cells both in vitro and in vivo.      PURPOSE:      To evaluate the efficacy and safety of Huaier Granule in treating women who have triple     negative breast cancer that has been surgically removed.   "
51215|NCT02615444|"     The purpose of this study is to determine whether daily consumption of soluble fibre, oat     beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in terms     of risk factors used to define metabolic disease.   "
51216|NCT02615431|"     The aim of the present study is to influence the central and obstructive sleep apnoea in     patients with severe mitral insufficiency by an interventional MitraClip examination to     evaluate.   "
84172|NCT02184260|"     Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in     the acute phase of ischemic stroke.   "
51218|NCT02615405|"     With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of     physical illness in depression, the serotonin hypothesis seems to fail in approaching the     etiology of depression. Based upon the evidence from epidemiological data, case-control     studies of PUFAs compositions, and antidepressant effects in clinical trials, phospholipid     polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the unsolved     of depression.   "
51219|NCT02615392|"     The purpose of this study is to test the effectiveness of prescribing park use (i.e., ''Park     Prescription'') to insufficiently active individuals. It is hypothesized that Park     Prescription will motivate the target population to increase physical activity and thereby     improve their physical and mental health.   "
51220|NCT02615379|"     EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site     infections (SSI).   "
51272|NCT02614690|"     This study aims to examine the need for univalve or bivalve splitting of casts in pediatric     patients with forearm fractures following closed reduction and cast application in a     randomized, prospective fashion.   "
51221|NCT02615366|"     Bleeding is an important consideration in breast surgeries that involve large resections of     soft tissues in the breast. Inappropriate bleeding during or after surgery, can lead to     uncomfortable fluid buildup in the breasts known as a hematoma or seroma, which may require     additional procedures or reoperation. Patients may experience a great deal of discomfort and     additional costs as a result; additional hospital time and procedures also burdens health     care spending. Tranexamic acid (TXA) is commonly used drug in many medical settings to reduce     excessive bleeding; however, no such drug is standard practice in breast surgery. The aim of     this study is to determine if TXA is superior to placebo in reducing the bleeding     complications in breast surgeries, including reduction mammaplasty, mastectomy with and     without immediate tissue expander and implant-based reconstruction, and oncoplastic breast     surgery. This study is a randomized, double-blind, placebo-controlled trial. Patients     undergoing these procedures will be randomly allocated to receive either TXA or placebo.     Patients will be placed on a drug/placebo regimen of 3 doses/day for 6 days starting on the     day of their surgery. The primary outcome is the incidence of hematoma and/or seroma     formation following breast surgery. Cost analysis of the intervention will also be performed.   "
51222|NCT02615353|"     Obesity and type 2 diabetes are critical public health issues in youth. This study will test     the effects and estimate the cost-effectiveness of a culturally-grounded community-based     lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with     prediabetes.   "
51223|NCT02615340|"     The purpose of this study is to determine the feasibility of conducting a randomized     controlled trial (RCT) with melatonin for prevention of delirium in critically ill adult     patients. The investigators hypothesize that melatonin, administered on a scheduled nightly     basis during ICU admission, will be efficacious and safe for the prevention of delirium in     critically ill adults.   "
51224|NCT02615327|"     Primary objective is to investigate the effect of polydextrose on postprandial glucose     concentrations in healthy adults when added to a food product.      Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.   "
51225|NCT02615314|"     The aim of this study is to analyze the clinical aspects of patients with BPPV associated     with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the     clinical aspect and the therapeutic outcome is different.   "
51226|NCT02615301|"     The aims of this study were to investigate how intake of tailor-made salmon affected bone     biomarkers, nutritional status, as well as body composition and bone mineral density. The 122     healthy postmenopausal women included in this 12 weeks intervention study were randomized     into four groups: three salmon groups (with three different vitamin D3/vitamin K1     combinations) and one tablet group (vitamin D and Calcium).   "
51227|NCT02615288|"     This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000     International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's     disease in remission.   "
51228|NCT02615275|"     The goal of this research study is to learn if mBCA, a type of scale that measures body mass     (the amount of muscle and fat in your body) and your level of hydration can help researchers     identify patients who are losing muscle mass during radiation therapy. This information will     help researchers make decisions about nutritional supplementation and the placement of     feeding tubes in patients receiving radiation therapy.   "
51229|NCT02615262|"     Perioperative administration of steroids has been demonstrated to reduce systemic     inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass.     However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis     of the present study: intraoperative administration of dexamethasone reduces complication     rates and improves clinical outcomes in infants undergoing repair of congenital heart defects     under cardiopulmonary bypass.   "
51230|NCT02615249|"     48-hour application of metal allergen patches to test for potential allergic responses.   "
51231|NCT02615236|"     The aim of the study is to evaluate the role of routine perineal scan using 2D ultrasound     immediatly after delivery to diagnose hidden perineal trauma that might affect patient's     fecal continance   "
51232|NCT02615223|"     This trial is going to evaluate tumor control and quality of life in patients with prostate     cancer treated with endocrine therapy with or without cryoablation.   "
51233|NCT02615210|"     The purpose of this study is to determine if cholangioscopically-directed biopsies provide a     higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures     when compared to standard means of sampling.   "
51234|NCT02615197|"     The present project has two primary aims: (1) to examine the effectiveness of a     multi-component implementation strategy in improving adoption and adherence to the     Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol, and (2) to evaluate the     feasibility, acceptability, and effectiveness of the DBT PE protocol in a sample of     individuals receiving DBT in public mental health agencies. This study uses a hybrid type 2     effectiveness-implementation design to simultaneously test the clinical effectiveness of DBT     + DBT PE and to evaluate an adaptive, multi-component implementation strategy. The     effectiveness trial will use a quasi-experimental, controlled design to evaluate outcomes     among DBT clients with PTSD who do versus do not receive the DBT PE protocol and outcomes     will be benchmarked to those obtained in research settings.   "
51416|NCT02612610|"     This is a 12-week, randomized, parallel, double-blind, placebo-controlled study of gefapixant     (AF-219) in subjects with refractory chronic cough.   "
51235|NCT02615184|"     The purpose of this study is to assess the safety and effectiveness of treatment with once     daily (QD) oral administration of dexlansoprazole 30 or 60 mg for 8 to 12 weeks in pediatric     subjects aged 1 to 11 years inclusive, with erosive esophagitis (EE) and to assess the safety     and effectiveness of dexlansoprazole 15 or 30 mg compared to placebo in maintenance of healed     EE for 16 weeks.   "
51236|NCT02615171|"     The purpose of this research is to develop and test a mobile application called RELAX, which     is designed to help with stress management during weight loss.   "
51237|NCT02615158|"     The hypothesis is that toddlers with parents who are randomized to a parenting intervention     and toddlers with parents who are randomized to the maternal intervention focused on maternal     diet and physical activity will be more likely to have weight status within normal and to     consume a healthy diet and engage in physical activity than toddlers with parents in a     placebo (safety) intervention.   "
51239|NCT02615132|"     Post-stroke communication deficits (PSCD) are a common symptom of patients having sustained a     stroke. These deficits include difficulty to produce or understand language, motor speech     disorders and cognitive-communication disorders. It is estimated that approximately 40% of     stroke survivors will have communication disorders post stroke.      In this randomized controlled study, the investigators' objective is to test the value of     providing a mobile platform-based Speech Language Therapy (SLT) program to patients     discharged from an acute care hospital with stroke and PSCD and awaiting outpatient rehab     services versus standard of care treatment. The investigators will offer iPad-based     SLT/standard of treatment to a convenience sample of 20 patients with post-stroke     communication deficits. The primary outcome will be feasibility (recruitment rate, adherence     rate, retention rate, and protocol deviations), and the secondary outcome will be improvement     in PSCD.   "
51240|NCT02615119|"     This study aims to identify the brain regions responsible for encoding cardiorespiratory     'interoceptive' sensations and determine whether they are dysfunctional in individuals     affected by eating disorders, anxiety, depression, or brain injury. By evaluating the same     interoceptive sensations across different human illnesses, the investigators hope to provide     convergent evidence resulting in identification of core underlying neural processes, and to     discern relative contributions in each condition.   "
51241|NCT02615106|"     The purpose of this study is to evaluate the safety and efficacy of Radiotherapy plus     Endostar(Recombinant Human Endostatin) in patients with Pediatric Neuroblastoma.   "
51242|NCT02615080|"     This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial     evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007     will be given as add on to a background of commonly used controller medication, i.e. inhaled     corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing     the background controller medication, the efficacy and safety of CRD007 will be evaluated on     top of several dose levels of this medication.   "
51243|NCT02615067|"     99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly     diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4     severity who are candidates for active surveillance and are undergoing voluntary radical     prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is     designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to     correctly identify subjects with previously unknown clinically significant prostate cancer.   "
51244|NCT02615054|"     This is for participants with a history of HER2-positive breast cancer and were treated with     chemotherapy that increases the risk of abnormal heart function. Strain (a marker of heart     function) is a new method of monitoring heart function in cancer patients and is measured     with an ultrasound. Exercise testing is another method that can be used to monitor for     abnormal heart function in cancer patients. The purpose of this study is to see if strain and     exercise testing can be used to detect for late signs of heart damage from chemotherapy.   "
51245|NCT02615041|"     The study was a randomized three-way crossover study. Each subject received meropenem in     three regimens at room temperature consecutively: (i) bolus injection of 1 g of meropenem     over 10 min every 8 h for 24 h, (ii) 3-h infusion of 1 g of meropenem via an infusion pump at     a constant flow rate every 8 h for 24 h, and(iii) 3-h infusion of 2 g of meropenem via an     infusion pump at a constant flow rate every 8 h for 24 h.      Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE     II score, BUN, Cr, Blood culture will be collected.      Nine patients will be enrolled in this study. After completion of the meropenem therapy for 3     days in this study, all patients will receive other sensitive antibiotics to eradicate their     bacterial infections.      Meropenem pharmacokinetic studies were carried out during administration of the third dose of     each regimen (16 to 24 h after the start of each regimen). Blood samples (approximately 5 ml)     were obtained by direct venipuncture at the following times: before (time zero) and 10 and 30     min and      1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the third dose of each regimen.      The concentrations of meropenem were determined by reverse-phase high-performance liquid     chromatography.      Concentration of meropenem in plasma will be simulated in Monte Carlo technique (Computer     model) to get PK/PD index (40%T>MIC) and reported to % PTA(Probability Target Attainment) and     %CFR (Cumulative Faction Response)   "
51246|NCT02615028|"     To develop a force plate with a proper computing algorithm that can be used in the average     household as well as within community care centers. An affordable price range will also be     necessary.   "
51247|NCT02615015|"     Neutrophil extracellular traps (NETs) and deoxyribonuclease (DNase) activity determine     outcome in ST elevation acute coronary syndrome (STE-ACS). DNase single nucleotide     polymorphisms (SNPs) were increased in a japanese cohort.      In the present study, the investigators seek to measure DNase SNPs frequency in a caucasian     STE-ACS cohort compared to healthy controls (each n=400). The investigators will compute     polymorphisms, DNase activity, NET surrogate markers and clinical variables in regression     models.   "
51252|NCT02614950|"     This is a Phase 2, two-step, open-label study of the outcome of analytic treatment     interruption (ATI) on patients who started antiretroviral therapy (ART) during Fiebig Stage I     of acute HIV infection (AHI), defined as detectable HIV-RNA without detectable p24 antigen or     HIV IgM. The primary endpoint will be rate of sustained viral suppression, defined as HIV-1     RNA < 50 cps/ml at 24 weeks after treatment interruption. During ATI subjects will be     monitored closely for safety and will have ART re-initiated if they meet predefined clinical,     virological, or immunological criteria. In step I, there will be 8 subjects who undergo ATI.     An interim analysis for safety will be conducted after 12 weeks. If none of the subjects     maintain viral suppression at 12 weeks then no further subjects will be enrolled into the     study. If at least 1 out of 8 subjects maintains viral suppression at 12 weeks then an     additional 7 subjects will be enrolled in step 2.      At ATI all antiretroviral drugs will be discontinued. Subjects will be monitored with     clinical exam, immunological (CD4), and virological (HIV-RNA) testing at baseline and then on     a fixed schedule for 24 weeks. ART will be re-initiated immediately if subjects meet any     pre-defined clinical, immunological or virological safety endpoints during the monitoring     period.   "
51255|NCT02614911|"     This study has been set up in order to characterize phenotypes and genotypes of patients with     early onset enteropathies.      In that goal, Investigators will collect biological samples (mainly blood) of patients     suffering from early onset enteropathies and their healthy relatives.   "
51256|NCT02614898|"     This is a prospective, open-label study with no patient randomization. Treatment for atypical     hemolytic uremic syndrome (aHUS) will remain observational and at the discretion of the     treating physician. The purpose of this study is to assess disease manifestations of     complement mediated thrombotic microangiopathy (TMA) and potential clinical predictors of     disease manifestations and progression in patients with aHUS with or without eculizumab     treatment in the clinical setting.   "
51257|NCT02614885|"     This is a single-arm, prospective study of a radiofrequency ablation device on the excised     breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by     the device will be analyzed histologically.   "
51258|NCT02614872|"     This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung     transplantation.   "
51259|NCT02614859|"     Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an     elevated insulin level in the blood is associated with a shorter median time to cancer     progression and median overall survival in patients with an elevated PSA after prior     treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used     in this patient population,with no proven benefit, which may increase mortality and     morbidity.This study evaluates how metformin in combination with bicalutamide affects     prostate cancer.   "
51260|NCT02614846|"     This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic     Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive     Hetrombopag.   "
51261|NCT02614833|"     The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the     active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in     patients with hormone receptor-positive metastatic breast cancer.   "
51262|NCT02614820|"     Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease     and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the     only proven effective medicine,while side effects limit its use. Recent studies have shown     that the vascular density in the DMD patients' muscle is decreased,so muscle are in ischemic     and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of resistanting     ischemia and hypoxia and maybe a potential therapy for DMD patients.      Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and     control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a blood     pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while control     group will receive a similar stimulus (inflation of a blood pressure cuff on the bilateral     thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels of     myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of     lower limbs）at 0 days, 3 days, 3months ,6months.      Purpose：        1. To evaluate the safety and tolerability of remote ischemic preconditioning for DMD          patients        2. To identify the effectiveness of remote ischemic preconditioning for DMD patients.   "
51263|NCT02614807|"     High blood pressure is very common among elderly Canadians. Clinical trials show clear     benefit from lowering blood pressure in hypertensive elderly patients. These trials also     demonstrate safety for several classes of blood pressure lowering drugs including water     pills. However, water pills (thiazide diuretics) used for treatment of hypertension, can     cause low sodium (hyponatremia), a significant clinical problem mainly among elderly and very     elderly. Causes are age related decrease in kidneys' ability to get rid of water and low salt     coupled with high water intake. A standard approach to treatment is lacking since higher salt     intake may worsen hypertension, and lower water and higher protein intake is difficult to     understand and actually implement. 'Nepro' is a nutritional drink high in protein, and low in     potassium and sodium. It is used frequently as a dietary supplement in patients with kidney     disease specifically for low sodium and high protein content. The high protein content in     Nepro can help the kidney get rid of excess water, and the low sodium and potassium content     will make this a safe option to use. Hence investigators propose a proof-of-concept trial on     an easy to understand and administer, and relatively affordable solution to this issue. It     could be summarized in one sentence: Will a bottle of Nepro a day keep thiazide-caused     hyponatremia and the doctor away?   "
51264|NCT02614794|"     The purpose of this study is to assess the effect of tucatinib vs. placebo in combination     with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on     independent central review.   "
51265|NCT02614781|"     This study is a non-interventional prospective, multicenter, longitudinal study conducted in     France, among a representative sample of public and/or private birth control centers.      The aim of the study is to assess, in real-life settings, the success rate of the protocol     Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or     beyond 7 weeks of amenorrhea.   "
51266|NCT02614768|"     The purpose of this study is to assess accuracy and reliability of the SPIDIMAN CGM sensor     system with regard to values as measured by Super GL and compare these results with similar     evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor and     the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.   "
51267|NCT02614755|"     The primary objective of this observational study is to determine performance characteristics     and usability of Lumosity and the Brain Performance Test in a group of older adult     volunteers.   "
51268|NCT02614742|"     This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in     Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.   "
51269|NCT02614729|"     The purpose of the main study is to determine whether the daily consumption of protein-rich     meals containing high quality, lean beef products improves appetite control and cognitive     function during a weight maintenance diet.      The purpose of the sub-study is to determine whether the daily consumption of protein-rich     meals containing the same amount of high quality, lean beef products improves appetite     control and cognitive function during a modest energy restriction, weight loss diet.   "
51270|NCT02614716|"     The main purpose of this study is to learn more about the safety and side effects of the     study drug known as LY3090106 in participants with Sjögren's Syndrome (SS). The study will     also evaluate how much of the study drug gets into the blood stream and how long it takes the     body to remove it.   "
53312|NCT02587767|"     The purpose of this study is to determine whether micropulse laser (MPL) is different to     half-dose photodynamic therapy on acute central serous chorioretinopathy.   "
51273|NCT02614677|"     Before 2007, the disability evaluation was based on the medical model in Taiwan. According to     the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment     of a person's eligibility for disability benefits has to be determined as suffering one of     eight malfunction categories based on the International Classification of Functioning,     Disability, and Health (ICF) framework. People with disabilities want to issue a disability     identification and other welfare & services need processes of evaluation & assessment based     on the ICF framework for the evaluation report and result of living need by the committee     composed of professionals from medicine, social work, special education and employment     counseling and evaluation.      In this year, investigators planed the project with the Taiwan Society of ICF to develop the     evaluation form. The experts from various disciplines of the ICF Office convened internal     integration meetings to reach a consensus for developed the ICF evaluation form, add the code     of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire.     The results were used to analysis other relevant factors affecting the disability evaluation.     And then add the core set from World Health Organization to both physical and mental     disorders linked coding group, compared the new disability evaluation system and evaluate the     living need of people with disability to provide suggestion for core set.   "
51274|NCT02614664|"     Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid     atresia) frequently have feeding difficulties necessitating procedures such as Nissen     fundoplication and G-tube placement. With advances in minimally invasive surgery, these are     frequently performed using laparoscopic techniques. Although generally safe and effective,     the increase in IAP during laparoscopy may increase systemic and pulmonary vascular     resistance and decrease cardiac output. This prospective study will include 50 patients with     single ventricle physiology presenting for laparoscopic procedures. There will be no change     in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation     will be monitored using near infrared spectroscopy (NIRS).   "
51275|NCT02614651|"     The main objective of this study is to quantify vision parameters in subjects with concentric     visual field constriction, and this in relation to the display on virtual reality goggles.     More specifically:        -  The maximum brightness value for visual comfort (THRESHOLD_MAX)        -  The minimum value of the perceptible light contrast in low light perceptible          (THRESHOLD_MIN)        -  The speed of light change adaptation in the range [THRESHOLD_MAX-THRESHOLD_MIN] and          [THRESHOLD_MIN-THRESHOLD_MAX].   "
51276|NCT02614638|"     The main objective of this study is to evaluate the impact of the presence of a pharmacy     technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.      This is a before-after study consisting of three sequential phases:      Month 1: one month of observation of what is happening in the department Month 2: one month     wash out period Month 3: active participation of a pharmacy technician in the department   "
51277|NCT02614625|"     An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new     clinical applications has recently been published in the peer-reviewed literature. However,     the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity,     biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative,     observational study aims to evaluate the imaging quality and diagnostic performance of two     commercially available SD-OCT machines for both the anterior and posterior segment of the     eye.   "
51278|NCT02614612|"     To determine if Itacitinib in combination with corticosteroids is safe and tolerable in     patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).   "
51279|NCT02614599|"     Multicenter, Prospective, randomized, comparative and controlled study about the beneficial     effects in behavior and brain connectivity of different dietary patterns in 100 children with     ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.   "
51280|NCT02614586|"     The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic     marker) in auditory sensory gating is demonstrated after administration of TAK-058 and     ondansetron compared to placebo in participants with schizophrenia.   "
51281|NCT02614573|"     The main objective of this study is to evaluate, for a 6-month observation period, the     concordance in terms of clinical decision making concerning therapeutic adjustment as     determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy     versus the usual strategy in a population of dependent elderly people in nursing homes,     treated with anti-vitamin K (AVK).   "
51282|NCT02614560|"     This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab     talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine     in sequence with standard treatments before a planned stem cell transplant, or as maintenance     therapy after a stem cell transplant. The main purpose of the study is to find the best dose     and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or     post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML.     This will be determined by assessing the safety and tolerability of vadastuximab talirine. In     addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will     be assessed.   "
51283|NCT02614547|"     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of     the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects     diagnosed with severe postpartum depression   "
51284|NCT02614534|"     The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy     (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal     carcinoma is effective in the treatment of locally advanced colorectal carcinoma.   "
51299|NCT02614131|"     The main purpose of this study is to evaluate the safety and tolerability of the study drug     known as LY2599666 in different groups of people - those who are healthy, those who have mild     cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The     study will measure how much LY2599666 gets into the bloodstream and how long it takes the     body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has     three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks.     Participants may only enroll in one part.   "
51458|NCT02612064|"     This single centre, dual site, comparative design study will be used to investigate the     efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal     hypersensitivity (DH) after short term use   "
51285|NCT02614521|"     Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3%     of the population, being associated with a 1.5- to 1.9-fold higher risk of death. Patients     with paroxysmal AF in whom antiarrhythmic drug therapy does not elicit a response are     potential candidates for RF ablation of AF. The success rate of RF ablation in the treatment     of AF varies depending on the type and duration of AF (ie, paroxysmal vs persistent),     structural remodeling of the heart, co-morbidities and the technique of the cardiac     electrophysiologist, but it usually ranges from 60-80% over 1-2 years of follow-up.      To study and predict the successful outcome of RF ablation is of great clinical importance.     Moreover, the detection of predictive factors for successful outcome may alter the     therapeutic strategy determining a subgroup of patients in the need of more invasive     management.   "
51286|NCT02614508|"     This phase I trial studies the side effects and best dose of buparlisib when given together     with ofatumumab or ibrutinib in treating patients with chronic lymphocytic leukemia that has     returned after a period of improvement or does not respond to treatment. Buparlisib and     ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways     by targeting certain cells. Giving buparlisib or ibrutinib and ofatumumab together may work     better in treating patients with chronic lymphocytic leukemia.   "
51287|NCT02614495|"     A multi-center , opened, Phase II study to assess the efficacy and safety of Sulfatinib 300     mg Sulfatinib in advanced Medullary Thyroid Carcinoma ( MTC) and iodine-refractory     differentiated thyroid carcinoma (DTC).   "
51288|NCT02614482|"     The purpose of this study is to evaluate the long term tolerability of Fesoterodine and its     efficacy for overactive bladder syndrome in children.   "
51289|NCT02614469|"     The purpose of this study is to assess the effects of food on the amount of urate in the body     after a single oral dose of inosine.   "
51290|NCT02614248|"     The purpose of the study is to examine the safety and effectiveness of the use of coconut oil     for the prevention and treatment of diaper dermatitis among NICU babies at Genesis Medical     Center, Davenport.   "
51291|NCT02614235|"     The purpose of this study is to determine whether continuous cardiac telemetry with the     Pocket-ECG III® system is more useful than conventional Holter to find out the cause of     syncope   "
51292|NCT02614222|"     The objective of this research is to determine if the addition of the Clear Guide ONE, a     Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing     ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can     visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician     better guide the needle to the target.   "
51293|NCT02614209|"     Plasma specimen collected from patients presenting in the Emergency Department (ED) with or     without Heart Failure (HF) and prescribed a BNP.   "
51294|NCT02614196|"     The main purpose of this study is to evaluate the efficacy of the study drug known as     LY2951742 in participants with episodic migraine.   "
51295|NCT02614183|"     The main purpose of this study is to evaluate the efficacy of the study drug known as     LY2951742 in participants with episodic migraine.   "
51296|NCT02614170|"     The study objectives are described below:        1. Obtain matched serum, plasma [(K2 EDTA, Sodium Heparin (NaH), Lithium Heparin (LiH)] and          urine specimens collected from a minimum of 50 healthy subjects. Specimens will be used          to determine a reference range for C-peptide and insulin assays, used as an aid in the          assessment of C-peptide and insulin in adults.        2. Obtain serum and urine specimens collected from a minimum of an additional 200 healthy          subjects. Specimens will be used to determine a reference range for C-peptide and          insulin assays, used as an aid in the assessment of C-peptide and insulin in adults.        3. To store any remaining specimens for use in future assay development and to evaluate as          yet undetermined assays for the development of IVDs, including additional C-peptide or          insulin assays.   "
51315|NCT02613923|"     Participants are asked to participate in a research study of the effect of a sleep     intervention on improving sleep habits and reducing their risk of breast cancer.      Participants are asked to participate in this research study because they have been     identified as being at higher than average risk of developing breast cancer.      The purpose of this study is to compare women who get a sleep intervention to women who do     not get a sleep intervention. This study team will compare these two groups of women to see     if the sleep intervention improves their sleep and if it lowers markers of inflammation that     have been associated with an increased risk of breast cancer.   "
51441|NCT02612285|"     SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of     the molecular chaperone heat shock protein 90 (Hsp90). Initial in vitro evidence supports     that SNX-5422 may be active against TP53 null tumors irrespective of tumor type .   "
51297|NCT02614157|"     Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal     cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on     whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy     (nCRT) between Western and Eastern countries. Retrospective cohort evidences indicate that     LLND following total mesorectal excision (TME) will bring benefit from cT3-4 rectal cancer,     not regular predictive LLND, which will bring more side effects on the contrary. Existing     reports tend to recommend LLND for specific individual with suspicious LLN metastasis.     Moreover, there is a blank strict prospective randomized control study on the comparison of     LLND+TME and LLND after nCRT. Therefore, our trial will compare the efficacy and safety of     the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors     (such as radiologic factors, pathologic factors, and serum protein) to predict local     recurrence and overall survival will be further investigated.   "
51298|NCT02614144|"     This project aimed at analyzing and assessing of the early and late Hospital-Acquired     Pneumonia(HAP) bacterial pathogens and their resistance to antimicrobial agents. The     incidence of their resistance to antimicrobial agent is assessed. Included are patients     hospitalized in the Intensive Care Departments of cooperated University hospitals, who     developed early or late HAP. Bacterial pathogens and their resistance to antibiotics are     identified using standard microbiological methods. The patient's mortality with respect to     their initial antibiotic therapy is statistically analyzed.   "
51300|NCT02614118|"     The aim of this study is premedication efficacy of analgesics on post endodontic pain.     Sixty-six healthy adult volunteers including criteria, are participating. The patients will     be divided into 3 groups and will be randomly given one of pre medications including 1) 10 mg     Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before     applying the injection. All patients will receive standard root canal treatment. Patients     will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success     will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be     analysed using Mann-U-Whitney and Kruskal-wallis tests.   "
51301|NCT02614105|"     The primary aim of the study is to investigate whether pelvic floor muscle training or     cough-suppression therapy reduces symptoms of urinary incontinence amongst women with chronic     obstructive pulmonary disease grade 1-4 (mild to very severe disease).   "
51302|NCT02614092|"     This two-year study will evaluate the feasibility of an exercise training augmentation for     cognitive training intervention to improve memory performance in Veterans with a diagnosis of     amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase     and 2) a cognitive training program. The exercise phase will be an aquatic based exercise     program. A combination of exercise and cognitive training programs designed for persons     without cognitive impairment have significantly improved memory more than other single     intervention groups (exercise only, cognitive training only) and given the success of     combination training programs with healthy older adults, it is important to adapt these     programs for persons beginning to exhibit clinically significant memory problems, such as     those with aMCI.   "
51303|NCT02614079|"     This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial     using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction     achieved correlates with the degree of stimulation.   "
51304|NCT02614066|"     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell     therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).   "
51305|NCT02614053|"     The purpose of this study is to evaluate the use of continuous noninvasive intraoperative     plethesmography variability index in conjunction with Hemoglobin levels monitoring using     Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with     antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .   "
51306|NCT02614040|"     This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal     saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for     intravenous fluid administration in the emergency department.   "
51307|NCT02614027|"     To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently     available antiretroviral drugs, and the prevalence of associated metabolic syndrome in     HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the     severity of fat accumulation and antiretroviral drug use.   "
51308|NCT02614014|"     Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease     (IBD) and the quality of life of these patients. A second aim is to establish the existence     of any psicopathological profile in these patients. We designed a prospective experimental     study were patients are randomized to receive or not a cognitive-behavior program. Patients     will be evaluated at 3 and 12 months after the program and study variables will be measured:     stress level, coping strategies, quality of life, activity of disease and biological     variables related to IBD.   "
51316|NCT02613910|"     This study is designed as a multi-country, multicenter, open label extension to Phase III     trial OPV116910. The primary objective is to provide continued treatment with ofatumumab     subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain     further long term safety and tolerability information in subjects with pemphigus vulgaris     receiving ofatumumab SC every 4 weeks (wk).   "
51317|NCT02613897|"     This is a 16-week, single center, randomized, double-blind, active-controlled,     parallel-group, Phase 3b efficacy and safety study of simultaneous administration of     saxagliptin 5 mg plus dapagliflozin 10 mg once daily (QD) compared with dapagliflozin plus     placebo for saxagliptin, and placebo for saxagliptin plus placebo for dapagliflozin in     patients with Type 2 diabetes who have inadequate glycemic control on metformin or     metformin/sulfonylurea.   "
51309|NCT02614001|"     Objectives: Little has been known the effectiveness of respiratory muscle training in     patients with both stroke and heart failure. To investigate the feasibility and effectiveness     of the inspiratory muscle training (IMT) in the respiratory muscle strength, cardiopulmonary     function, exercise capacity, fatigue and quality of life in stroke patients with congestive     heart failure.      Design: A single-blind prospective randomized controlled study. Setting: A tertiary care     medical center. Participant and method A total of twenty stroke patients with stable CHF,     class I-III [NYHA (New York Heart Association)], aging between 20 to 85 year-old, will be     eligible and randomly assigned into IMT and control group. Stroke will be confirmed by     computerized tomography or magnetic resonance imaging. And CHF will be confirmed by a     cardiologist. Both of groups will receive a conventional stroke rehabilitation program and     diaphragmatic breathing training. The IMT groups will be trained daily, 30 minutes per day,     at least 5 times a week, for 4 weeks; then readmitted to hospital 2 weeks later. For checking     the compliance of IMT at home, patients will be monitored by making a phone call to them     twice a week. Or patient will receive an out patient program about 10 weeks if they are not     admitted to our hospital.      Main outcome measurement:      Each subject's baseline characteristics, and duration of the disease, neurological level     (Brunnstrom's stage), functional level, spirometry; resting heart rate, blood pressure,     resting oxyhemoglobin saturation (SpO2), lowest resting SpO2, maximal inspiratory pressure,     maximal expiratory pressure, the resting oxyhemoglobin saturation (SpO2), lowest resting SpO2     and Borg's scale during a 6-minute walking test , handgrip strength, visual analog scale for     severity of fatigue, fatigue assessment scale, Barthel scale will be assessed before and     after program.   "
51310|NCT02613988|"     This clinical trial studies advanced MR imaging techniques in measuring early response of     standard treatment may become predictors of long-term treatment response in patients with     newly diagnosed glioblastomas.   "
51340|NCT02613598|"     The primary objective of this research study is to determine the maximum tolerated dose (MTD)     of Ruxolitinib (Jakafi) in combination with standard dose Bortezomib (Velcade) in patients     with relapsed or refractory Hodgkin (HL) and Non-Hodgkin Lymphoma (NHL).   "
51353|NCT02613429|"     Literature shows that anaesthetists have a low success-rate when trying to access the airway     percutaneously in case of failed ventilation and intubation.      The study will investigate anaesthetists ability to locate the trachea and the thyroid     cartilage and the cricoid cartilage in patients, using different methods including     application of ultrasonography.   "
51311|NCT02613975|"     Positional therapy is considered as a kind of conservative treatment especially for patients     with OSA which varies with body positions, and has been reported to be useful in selected     cases especially those with positional OSA. Positional OSA is present when the overall apnea     hyponea index (AHI) is > 5/hr with a supine AHI being more than 2 times of AHI in other     positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group     1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They will     be provided with a vibration device as treatment, which will be worn on the neck during     sleep. This device senses the position of the patient during sleep. It will vibrate when the     patient lies supine until the patient turns laterally, thus prevents the patient to lie flat     during sleep and reduce the severity of OSA. It will be switched on and off for a period of     15 days alternatively with sleep study performed at the end of each period respectively to     determine its efficacy in the on and off mode. There will be a wash out period of 1 week in     between the on and off period to remove any residual effect. Group 2 consists of patients     with positional OSA who are using dental device but response or tolerated poorly. They will     use the vibration device with dental device together as dual therapy, to assess the role of     combination therapy. The device will be operated in on and off mode with sleep study being     performed in a similar manner as in group 1. Informed consent will be signed. Each     participant will have 2 sleep studies performed at home, which will be supported technically     by technician visiting their home for hook up of necessary equipment.   "
51312|NCT02613962|"     In the light of the development of high-throughput technologies enabling a biology-based     reclassification of tumors and the increasing number of available specifically targeting     anticancer agents the era of precision medicine has begun. Several clinical precision     medicine trials with the aim of stratifying treatment according to molecular profiles (for     example in France: 'MOlecular Screening for CAncer Treatment Optimization' MOSCATO-01, SHIVA,     PROFILER, Safir01, Safir02) are ongoing in adults and have shown the feasibility of this     approach. MOSCATO-01 is the first trial worldwide including pediatric patients, performing an     on-purpose intervention and molecular profiling in recurrent tumors. Together with more than     500 adult patients, between December 2012 to August 2014, the tumors of 35 children and     adolescents have been profiled, confirming that this approach is feasible in pediatric     patients albeit with accelerated time stringencies. Importantly, the results of the first     children and adolescents profiled showed that 2/3 of patients had 'actionable' alterations     using hot spot mutations sequencing and CGH array (Geoerger B et al, ASCO 2014).      The project 'MAPPYACTS' will use both Whole Exome Sequencing (WES) and RNA Sequencing of     tumor tissue to increase the number of targetable genomic alterations. Furthermore to improve     understanding of the overall molecular profile and possible response to treatment,     methylation array, miRNA expression profiles, and study of immunomodulators will be performed     on tumor samples subsequently. CLIP2 (INCa-labeled early phase clinical trials centers) -     SiRIC (INCa- labeled comprehensive cancer centers) molecular profiling and bioinformatics     platforms will contribute with their expertise in molecular profiling projects and     characterization of pediatric cancers. Data interpretation of molecular genetic alterations     detected by WES and RNA Seq and treatment recommendation will be done within a     multidisciplinary therapeutic molecular biology tumor board.      'MAPPYACTS' will produce one of the largest cohorts of molecularly characterized relapsed     tumors reported to date, and thanks to increased access to clinical trials since the European     pediatric legislation, the investigators expect that 20-30% of patients can be stratified     into a targeted trial based on the detected profile.      It is the investigators' intention that this initiative paves the way to enrich ongoing     clinical targeted agent trials, to increase the numbers of stratified clinical trials, to an     earlier access to targeted agents, and will play a crucial role in the relevant development     of these new agents in pediatric malignancies.   "
51313|NCT02613949|"     The purpose of this study is to test the safety and efficacy of a noninvasive cortical     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical     Electrostimulation (RINCE) in the treatment of pain associated with fibromyalgia. Patients     who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up     to 24 RINCE treatments delivered by a medical device called NeuroPoint. Approximately 45     fibromyalgia patients will be randomized into one of three study groups. One of these groups     will receive sham treatment, meaning they will receive no treatment at all. A second group     will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A     third group will receive active RINCE treatment at a higher than nominal signal amplitude     level (treatment mode 2). The study's primary outcome measure will be the difference between     active and sham treatment groups in the mean change from baseline in patients' 24-hour recall     average pain scores. The study's hypothesis is that there will be a difference between     treatment groups in primary outcome measure.   "
51314|NCT02613936|"     80 patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 2     years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study     they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left     dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (40     active, 40 sham) combined with cognitive training. On day 10 NP testing will be obtained     again. On Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of     life, depression, and post concussive symptoms will be assessed.   "
51370|NCT02613208|"     This multicenter, observational, prospective study will identify a powerful and easy     predictive/prognostic marker to use with participants under bevacizumab.   "
51371|NCT02613195|"     The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve     the quality of aging grafts in liver/kidney transplantation.   "
51799|NCT02607605|"     The primary purpose of this study is to compare the positive rate between the cell-free DNA     and cytological examination of cerebrospinal fluid in Advanced lung cancer with     leptomeningeal metastases.   "
51318|NCT02613884|"     Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than     or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to     participate in this study. Upon consent, they will be given oral cholecalciferol     supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed     by measuring a serum calcium level within 1 week of supplementation. Efficacy will be     assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be     assessed with the previous two measures as well as a brief questionnaire administered via     telephone within 1 week of supplementation.   "
51319|NCT02613871|"     This study will evaluate the antiviral efficacy, safety, and tolerability of     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in     chronic genotype 1 or 2 HCV infected adults who are co-infected with HBV in Taiwan.   "
51320|NCT02613858|"     The Preempt study is likely to help determine the frequency of patients suffering from     Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about     the Quality of life of these patients.   "
51443|NCT02612259|"     A phase II, randomized, double-blind, placebo-controlled, in parallel groups clinical trial     to assess the safety and efficacy of dietary supplementation with tryptophan to achieve     weight loss, and its neuropsychological effects in adolescents with obesity.   "
51321|NCT02613845|"     The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium     as a disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift     attention) and awareness (reduced orientation to the environment). In addition, a     disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial     ability, or perception) occurs.      Postoperative delirium (PD) usually develops in connection with a surgical procedure within     the first five days after an intervention. Roughly 10-70% of all surgical patients above the     age of 65 years are affected.      PD places not only a burden to the patient and their families by increasing functional and     cognitive damages, and increasing mortality, it also has a high impact on the health care     resource utilization. A patient with PD often requires more intensive care, has a longer     length of hospital stay, more complications, and often requires long-term care after being     discharged from the hospital. All these aspects show the need for prevention of PD.      There are various preoperative risk factors that influence the development of PD. Broad     research has been done on this topic and shown that advanced age, cognitive impairment,     depression and other psychopathologic symptoms, intake of psychotropic substances, sensory     impairment like decrease in visual or auditory perception, impairment in daily life     activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severity of     disease and different comorbidities, such as chronic cardiac insufficiency, atrial     fibrillation, or previous history of stroke or infections may favor the occurrence of PD.      The incidence of PD is among the highest in cardiac surgery. The study was designed to assess     predictors for PD after cardiac surgery. Study hypothesis is that some patient variables,     scores and biomarkers are not only predictive of the incidence of PD but also of the severity     of delirium-associated symptoms and duration of PD after cardiac surgery.   "
51322|NCT02613832|"     The survival of patients with lesions in the central nervous system is usually accompanied by     physical and mental sequelae. These impairments favor the prolonged restriction to the bed,     which may contribute with changes in respiratory function. In this context, lung re-expansion     techniques are used to prevent or treat the various respiratory complications.   "
51323|NCT02613819|"     This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy     (SABR) for the treatment of kidney cancers.   "
51324|NCT02613806|"     Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative     bleeding.Postoperative bleeding is a serious and potentially life-threatening     complication，which could result in acute upper airway obstruction due to neck hematoma and     increase the need for re-operation.The purpose of this study is to investigate whether     dexmedetomidine can reduce the incidence of postoperative coughing and contribute to     postoperative recovery in patients undergoing tyroid surgery with general anesthesia.   "
51325|NCT02613793|"     This study is recruiting two groups of women over the age of 18; those who are pregnant and     who have pre-eclampsia; and those who are pregnant but do not have pre-eclampsia. The aim is     to test a new method of diagnosing and monitoring pre-eclampsia and thus prevent the     long-term damage it can cause to the baby's health. Untreated, pre-eclampsia can lead to     seizures in pregnancy (eclampsia) and may prove fatal for mother and child.      Currently the only effective treatment for pre-eclampsia is control of the mother's blood     pressure until it is safe to deliver the baby. The timing of delivery is kept under constant     review by the medical team, who must balance the risk to the mother of developing eclampsia     against the risk to the baby of being born too early (premature).      If pre-eclampsia can be diagnosed early, there is a greater chance of being able to treat it     effectively. We know that women with pre-eclampsia often have exaggerated reflexes in their     limbs (hyperreflexia) and that this may be linked to the risk of seizures. Measuring these     reflexes might therefore be a useful way to diagnose and monitor pre-eclampsia, but doing     this is not easy, so we want to assess whether measuring other reaction times might similarly     help assess the risk of seizures. One possibility is by measuring the reaction time as we     flick our eyes to follow a moving target, using an instrument called a saccadometer, which is     worn on a head-band, a little like a head-torch.      By comparing the results between these groups and the non-pregnant women, we will be able to     see if reaction times from the saccadometer are altered in women with pre-eclampsia, and, if     so, whether saccadometry might be useful in helping doctors decide the best time for safe     delivery.   "
51326|NCT02613780|"     Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to     significant visual deterioration over time. Corneal collagen crosslinking with riboflavin     (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate the     need for corneal transplantation. However, the treatment alone has little impact in terms of     improving visual function. Photorefractive keratectomy (PRK) is the application of an excimer     laser to treat a patient's refractive error, therefore decreasing the dependence on     spectacles or contact lenses for improved vision.      Corneal collagen crosslinking combined with photorefractive keratectomy has been explored to     partially correct the refractive error in keratoconic patients, whilst simultaneously     stabilizing the corneal changes. Recently, the iDesign® Advanced WaveScan Studio (iDesign     system; Abbot Medical Optics; Santa Ana, CA) has been launched as the most advanced     high-resolution aberrometer. It is capable of mapping highly aberrated corneas for     wavefront-guided laser procedures, and represents an important technological advance in     treating corneal disease.      The purpose of this single center, prospective pilot study is to assess the safety and     efficacy of combined wavefront-guided PRK and CXL in patients with early keratoconus using     the iDesign® aberrometer. Results of this pilot study will be used to provide sample size     estimates for an extension of the study, which aims to determine whether sequential or same     day procedure leads to better outcomes.   "
51800|NCT02607592|"     The purpose of this study is to investigate the overall toxicity value（OTV）, PFS, ORR and OS     on advanced adenocarcinoma treated with nadaplatin or cisplatin combined with pemetrexed.   "
51338|NCT02613624|"     The study is being conducted to develop an intervention to assess the feasibility of     implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a     community setting. A prototype intervention package will be developed using information     obtained from in-depth interviews, focus group discussions and other qualitative research     techniques. These interviews will help us identify current behaviours, barriers to adoption     of KMC and effective ways to promote KMC in the community. The prototype intervention will be     refined by conducting acceptability studies (household trials) with few mothers. The study     team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC     and following up till KMC is stopped. The process is being documented using observations and     interviews. Information is obtained on acceptability of KMC, number of hours per day and     number of days KMC was given, breastfeeding practices and support provided by other family     members.   "
51339|NCT02613611|"     Examination of cervical &urine samples for HPV   "
82162|NCT02210520|"     The low level laser therapy has a better effect in decrease the pain than ultrasound     therapeutic.   "
51327|NCT02613767|"     There are an increasing number of individuals in the United States with obesity, and this is     a major health concern with links to many chronic diseases. Impairments in protein metabolism     with obesity may disrupt muscle function and modify the dietary protein requirements in obese     individuals. Further, overweight and obese type 2 diabetics exhibit dramatically reduced     skeletal muscle mass compared with lean, healthy controls. Surprisingly, the influence of     being overweight or obese on this decline in muscle mass remains understudied, despite clear     evidence that similar metabolic impairments typically exist in these populations prior to the     development of overt diabetes. Protein ingestion provides the amino acid building blocks to     synthesize and repair muscle proteins in adults. Previous research has shown that the muscle     protein synthetic response to food ingestion may be reduced in overweight/obese adults.     However, this research provided the 'free' amino acids in small portions every 15 min during     the postprandial period. In free living conditions, however, it is more common to consume     protein dense foods in single portions. Currently, there is no information available on how     eating protein rich foods affects muscle protein synthesis in overweight and obese adults.     This proposed research will fill this research gap by being the first study to compare the     muscle protein synthetic response to the ingestion of a meal-like amount of high quality     protein in lean, overweight and obese adults. The objective of this study is to determine the     muscle protein synthetic response after the consumption of 35g pork protein in lean,     overweight and obese adults. In order to assess this objective the researchers propose to use     primed continuous infusion of L-[ring-13C6] phenylalanine to measure muscle protein synthesis     rates after the consumption of dietary protein. In a parallel design the researchers will     study 13 obese (BMI 30-39.9 kg/m2) participants, 13 overweight (BMI 25-29.9 kg/m2), and 13     age-matched lean controls (BMI 18-24.9 kg/m2) between the ages of 20 and 45 years. All     subjects will be sedentary and weight stable for the previous 6 months. On the test day,     subjects will remain sedentary for the determination of muscle protein synthesis in both the     fasted state and after consumption of the protein meal. Blood and muscle sampling will occur     on the test day.   "
51328|NCT02613754|"     The aim of this study is to conduct a trial to investigate the efficacy of adding Contingency     Management (CM) to Treatment as Usual (TAU) for the treatment of Disordered Gambling. Results     from this experiment will provide the first evidence of the additional efficacy of     best-practice CM and whether it can be easily integrated into a clinical environment.     Additionally, this study will correlate clinical outcomes with psychological measures and     participant responses to develop new predictive treatment outcome measures.   "
51329|NCT02613741|"     Since obesity and plasma fibrinogen levels are important CVD risk factors in the adults, and     since childhood obesity is a major risk factor for adult obesity and also because it is not     established whether or not this is due to an increase in the FSR of fibrinogen, the     investigators set up the studies with the following specific aims:        1. To investigate the metabolism of fibrinogen and VLDL apoB-100, CVD risk factors, in          childhood obesity by measuring their fractional synthetic rate (FSR) compared to lean          age and sex matched controls        2. To determine the outcome of a three month non-pharmacological intervention (physical          exercise combined with controlled diet) to reduce weight on the FSR of fibrinogen and          apoB-100        3. To determine the relationship between FSR of fibrinogen and IL-6 in obese children and          its potential implications on CVD before and after the non-pharmacological intervention        4. To determine other CVD risk factors, PAI-1 levels, D-Dimer concentration, homocysteine,          insulin, free fatty acid, HDL & LDL cholesterol and blood pressure in response to weight          reduction (as consequence of a combined program of diet and exercise).   "
51330|NCT02613728|"     The goal of this clinical research study is to learn if RecoverMI care can help to shorten     the time that patients are in the hospital after surgery and if it can help them recover     sooner.      RecoverMI includes the following parts:        -  Preoperative Education        -  Early oral intake        -  Early mobilization        -  Telemedicine   "
51331|NCT02613715|"     The main aim of this study is to evaluate the bioavailability of blackberry juice     anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.   "
51332|NCT02613702|"     This study will compare a new technique of free gingival graft to the original one, in order     to evaluate the stability of the graft volume over one year and other variables. Twenty     patients will receive the original technique of free gingival graft (controls) and twenty     patients will receive the modified technique, in which the free gingival graft is submerged     (tests), at the inferior incisors area.   "
51333|NCT02613689|"     The purpose of this study is to evaluate the feasibility, acceptability and preliminary     efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS)     text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural     population.   "
51334|NCT02613676|"     In South Africa, healthy term newborns are usually discharged early (<72 hours after     delivery). Many studies have shown that hospital readmission rates have increased with this     practice, and jaundice or hyperbilirubinemia is the most common cause of readmission of     newborns. Peak serum bilirubin levels usually occur on postnatal days 3-5, by when many have     already been discharged putting the infant at increased risk of severe hyperbilirubinemia.     Severe neonatal jaundice still constitutes an important cause of neonatal mortality and     morbidity in Africa. Screening all newborns for the risk of severe hyperbilirubinemia before     hospital could help in early identification of hyperbilirubinemia and early intervention and     potentially prevent unwanted consequences like bilirubin induced neurological dysfunction.     However, there are conflicting recommendations on the use of universal transcutaneous     bilirubin screening for jaundice in all newborns before hospital discharge.   "
51335|NCT02613663|"     A successful implant therapy require appropriate hard and soft tissue, perfect implant     position, appropriate alveolar ridge architecture and integration of the implant. after tooth     extraction bone resorption takes place and affect the quantity and quality of the bone     resulting in inadequate bone volume for implant placement and future prosthetic restoration     and impair the esthetic, so insertion of implant immediately following tooth extraction     reduce bone loss and enhance esthetics.the fresh socket of extracted tooth is wider than the     implant diameter and the distance between the implant and the bone called Peri-implant gap     which influence the stability, osseointegration of the implants and esthetics. using bone     graft in this gap between bone and implant enhance osseointegration and post-operative     healing. autogenous bone graft considered the gold standard graft material for filling     defects as it is osteogenic,osseoconductive and osseoinductive, however this approach     obtained from the primary donor site for harvesting bone in the oral cavity which requires     longer surgical procedure and produce not enough bone volume. there are several     post-operative complication may happen as donor site morbidity and swelling,discomfort and     pain, so alternative treatment has been suggested using biomaterials to fill the gap and     reduce adverse effect of autogenous grafts.Several studies evaluate the success rate of     implants with autogenous bone graft versus other synthetic guided bone regeneration     materials. Nano porous grafting material as a new synthetic material nanobone     nanocrystalline hydroxyapatite embedded in a porous silica gel matrix has oseoconductive and     biomimetic properties integrate with the host bone. the sub-micron modification in bone     substitutes enhance osteogenic property. the objective of this study is to measure surgical     time, pain, implant stability and marginal bone loss in immediate implant placement with     using autogenous bone graft versus nanobone graft.   "
51336|NCT02613650|"     This is a Phase 1b, open label, dose-finding study to determine the Maximum Tolerated Dose     (MTD) of MEK162 in combination with mFOLFIRI, and to evaluate the response rate, clinical     benefit rate and additional safety parameters of the treatment combination   "
51337|NCT02613637|"     Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly     Diagnosed or Existent Lung Cancer      The LuCa Biology and Outcome (BiO)-Project   "
51341|NCT02613585|"     Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This     study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and     the surrounding area that will address the following study aims: 1) Evaluate the     effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme endemic     areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and 3)     Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI     clothing.   "
51342|NCT02613572|"     Because of its iron-chelating and antioxidant properities, alpha lipoic acid may be a     treatment for geographic atrophy secondary to age-related macular degeneration. There is     ample published data about the safety and pharmacokinetics of alpha lipoic acid in adults.     However, there is not much data on the safety and tolerability of higher doses of alpha     lipoic acid in the elderly population. The purpose of Phase I of this protocol is to     determine if there are safety/tolerability concerns seen when higher doses of alpha lipoic     acid are taken by subjects 65 years of age or older.      The objective of Phase 2 of this protocol is to determine the effects of ALA on the     progression of GA in subjects with AMD. The central hypothesis, based on the existing     literature, is that oral ALA reduces the rate of enlargement of GA in AMD subjects. The     rationale is that the antioxidant and iron chelating effects of ALA will slow down one of the     major pathways responsible for GA progression.   "
51343|NCT02613559|"     The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and     tolerability of single ascending doses of TK001(Recombinant humanized anti-VEGF monoclonal     antibody) to determine the maximum tolerated dose (MTD) in neovascular wet age-related     macular degeneration (wAMD) subjects.   "
51344|NCT02613546|"     This research is a randomized clinical trial aims to evaluate the influence of     cognitive-behavioral psychotherapy (CBT) on quality of life and sexual function of patients     with sexual dysfunction. The notion of sexual health for the World Health Organization     exceeds the concept of sickness absence, having a subjective well-being of significance in     the spheres of self-concept, self-image, interpersonal relationships and sense of self worth.     Furthermore, sexual satisfaction and relationship quality of life is also evidenced in many     studies. CBT is a brief and focal psychotherapy with proven efficacy in several mental     disorders, improving health and quality of life of the treated populations. However, they did     not find clinical trials that showed the effectiveness of CBT in Sexual Dysfunctions. This     study aims to then fill this gap by evaluating the relationship from the use of techniques of     CBT.   "
51345|NCT02613533|"     The water drinking test (WDT), is a predictive test that has been used to detect primary open     angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension     curve. Clinically accurate provocative tests for asymptomatic eyes with shallow anterior     chambers and narrow angles are highly desirable to detect patients prone to angle closure     glaucoma. The aim of this pilot study is to evaluate the possible role of water drinking test     in patients with narrow angles who are scheduled for prophylactic laser iridotomy.   "
51346|NCT02613520|"     The present trial will evaluate safety and tolerability as well as the vaccine-induced     humoral and cellular immune responses in healthy Tanzanian adults, adolescents, children, and     infants who receive doses of 1.8x10^6, 9.0x10^5, 4.5x10^5 or 2.7x10^5 PfSPZ of PfSPZ Vaccine     by direct venous inoculation (DVI),compared with control groups receiving normal saline (NS)     placebo by DVI. In addition, as an exploratory objective, controlled human malaria infection     (CHMI) will be used to assess efficacy in adults three weeks following immunization.   "
51347|NCT02613507|"     The purpose of this study is to determine whether Nivolumab improves life expectancy compared     to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have     failed prior platinum-based doublet chemotherapy.   "
51348|NCT02613494|"     A randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the     treatment of clozapine-induced hypersalivation to assess recruitment and retention rates in a     multi-centre trial.   "
51349|NCT02613481|"     This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid     (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will     receive Sculptra™.   "
51350|NCT02613468|"     The objective of this study was the evaluation of periodontal condition in pregnant women and     the effect of the treatment of periodontal disease upon low birth weight.   "
51351|NCT02613455|"     The purpose of this study is to prospectively compare the pain and functional outcomes of     patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid     injection or high energy extracorporeal shock wave therapy (ESWT).   "
51372|NCT02613182|"     The rationale for this study is to provide additional treatment with NEOD001 for subjects who     complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability.     All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be     continued in this study.   "
51373|NCT02613169|"     Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium     tuberculosis infection in HIV-exposed uninfected (HEU) infants.   "
51352|NCT02613442|"     Objective: To determine the clinical variables that influence aqueous outflow facility (Co)     and intraocular pressure (IOP) in uveitis.      Uveitic glaucoma is potentially blinding and occurs in 17-46% of chronic uveitis patients.     Uveitic activity causes fluctuating IOP due to decreased Co, increased uveoscleral outflow or     decreased aqueous production.      Specific Aim 1: To evaluate the risk factors for high IOP and low Co in uveitis Hypothesis:     Decreased Co and increased IOP will occur with increasing anterior chamber (AC) flare, AC     cells, degree of synechial angle closure, increased duration of disease, higher uveitis     activity and increasing steroid use Specific Aim 2: To determine prospectively the effect of     AC flare on Co and IOP in quiescent uveitis Hypothesis: AC flare even in the absence of AC     cells will cause progressive decline in Co.      Methods: In this proof of concept study, thirty consecutive patients with acute or chronic     uveitis will be recruited from the uveitis clinic. Ten patients with quiescent uveitis (no     AC cells) will be recruited for the prospective arm and followed every 2-3 months for 3     visits. Co will be measured using 2-minute pneumatonometer tonography. The effect of risk     factors on IOP and Co in uveitis will be studied using generalized linear modelling     techniques. These risk factors include AC flare (using the laser flare meter), AC cells,     degree of angle closure (by gonioscopy), duration of disease, disease activity and     corticosteroid use within the last year. In the prospective study, the patients will be     divided into subgroups with low flare (< 20ph/ms) and high flare (≥ 20 ph/msec) and the     change in Co and IOP will be analyzed.      Impact: This will be the first study to systematically analyze the risk factors for decrease     in Co and increase in IOP in uveitis and to prospectively evaluate the effect of AC flare on     Co. Proof that AC flare can damage the trabecular meshwork will corroborate previous     experimental evidence and change the paradigm of uveitis treatment. Knowledge of the risk     factors that affect Co and IOP will aid in identifying patients that may need escalation of     their uveitis or glaucoma treatment to prevent optic nerve damage.   "
51456|NCT02612090|"     Primary objective is to assess strawberry intake on LDL cholesterol and its association with     atherosclerosis development.   "
51354|NCT02613416|"     This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection monthly     in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are currently     not receiving anticancer treatment with hormonal therapies, chemotherapy, or radiation. All     patients will undergo quantification of breast density by MRI at baseline 1, baseline 2     (after 3-month observation period) and after 3 and 6 months on denosumab, which means after     0, 3, 6 and 9 months after entering the study. Because the therapeutic agent is an injectable     drug, the investigators will conduct a single arm study with both pre- and post-treatment     measurements to determine the extent of variability in breast density over time and a placebo     treatment period or group will not be utilized. This is an investigator initiated trial and     Amgen (SPONSOR) will provide the trial drug denosumab.   "
51355|NCT02613403|"     This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172     (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks     with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis     C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a     direct-acting antiviral regimen (DAA). The combination regimen will be administered as two     fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.      The study will evaluate the efficacy of the combination regimen of MK-5172 (GZR), MK-3682 and     MK-8408 (ruzasvir) with or without ribavirin as assessed by the proportion of participants     achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.   "
51356|NCT02613390|"     The goal of this clinical research study is to learn about the safety and accuracy of using     MRI as a guidance system during laser ablation surgery of tumors that have spread to the     spine.   "
51357|NCT02613377|"     Transfusions cause more adverse events in children than in adults. Patients in pediatric     intensive care units (PICU) are particularly exposed to transfusions of plasma-rich blood     products (red blood cell (RBC), plasma and platelets) and the risk of adverse events after a     transfusion is particularly high in this vulnerable population. Transfusion-related acute     lung injury (TRALI), an acute inflammation of the lungs that impairs gas exchange leading to     acute respiratory failure, is one of the 2 most deadly transfusion complications in the     general population. There is limited evidence on TRALI incidence and impact in critically ill     children. This reduces the awareness of PICU team for this complication, and makes the     decision process to transfuse particularly difficult. Moreover, acute lung injury is highly     prevalent in critically ill children. It is therefore complex to ascertain if the high     frequency of respiratory deteriorations observed after a transfusion in PICU is explained by     the transfusion itself or by the evolution of the patient's critical illness.      The investigators will conduct a cohort study of consecutive transfused critically ill     children, with a control group of matched non-transfused children. The primary objective is     to determine if transfusion of RBC, plasma and/or platelets in PICU is an independent risk     factor of TRALI, and to compare the respiratory evolution in the two matched (transfused and     non-transfused) groups. The secondary objectives will include the determination of the     incidence rate, risk factors and clinical impact of TRALI in transfused PICU patients. The     investigators will study both classic TRALI and delayed TRALI.   "
51358|NCT02613364|"     This randomized phase III trial compares yoga, survivorship health education program, and     cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors.     Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty     staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair     physical function, impair immune function, cause circadian rhythms (known as the biological     clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms,     physical and immune function, and improve insomnia and sleep quality in cancer survivors. It     is not yet known whether yoga is more effective at treating insomnia than a health education     program or cognitive behavioral therapy program.   "
51359|NCT02613351|"     The aim of this study is to determine if: the large muscles of the leg, activated during     walking, are also active during scooting; whether scooting alters the relationship between     leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.   "
51374|NCT02613156|"     This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of     recurrent hepatocellular carcinoma (HCC).   "
51375|NCT02613143|"     The purpose of this study is to assess the zonulo-hyaloido-vitrectomy for malignant glaucoma     through an anterior approach.   "
51376|NCT02613130|"     This study will assess changes in oral malodor and other factors in response to using a     two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.   "
51377|NCT02613117|"     This study will assess the oral tolerability and immediate post-treatment safety of topical     application for two marketed oxalate products as initial care in dental patients to treat or     prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.   "
51360|NCT02613338|"     A better understanding of knee joint kinematics is important to explain the premature     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a     prosthesis that most closely approximates the normal knee. Specifically, posterior     stabilizing (PS) knees have been found to be associated with lower amounts of posterior     femoral rollback, higher occurrence of reverse axial rotation and increased amount of     condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee     system has incorporated subtle changes in its design to address restoration of kinematics     that more closely resemble those of a normal knee. To understand if this design is able to     effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.     This continuation of the study will analyze 30 subjects with the Attune PS FB 3 months     post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing     three daily activities, level walking, ramp down and deep knee bend.   "
51380|NCT02613078|"     Current study aims to investigate the influence of gut-directed hypnotherapy and probiotic     nutritional supplement (SymbioLact B) on gastrointestinal symptoms in children with     functional abdominal pain or irritable bowel syndrome compared to self-observation only. The     study also includes collection of psychometric data (emotional and behavioral problems, pain     coping strategies), data on activity of the autonomous nerve system as measured by heart rate     variability and data on stress response (saliva cortisol levels).   "
51361|NCT02613325|"     The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate     both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed     by histological examination, the investigators anticipate that they will be able to     non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma,     tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs     surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow     non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma     diagnosis and management - potentially an earlier and more definitive surgical management.      In addition, the investigators propose to use the combination of fPAM and single-cell PAM to     respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators'     murine models, the investigators anticipate that they will be able to differentiate CTCs from     other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC     concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic     potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to     develop a sensitive imaging device that will allow accurate evaluation of the risk of     melanoma recurrence and metastases, that may facilitate treatment monitoring.   "
51362|NCT02613312|"     The purpose of this study is to determine the response rate and overall survival in patients     that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and     intensity modified radiation therapy (IMRT) as part of their standard of care.   "
51363|NCT02613299|"     The purpose of this study is to determine whether radiation therapy decreases tumor size and     tumor spread. The investigators will consent subjects that have been diagnosed with     mesothelioma and will undergo radiation therapy followed by surgical resection as their     standard of care. The investigators will collect data from past and future medical records as     well as data regarding their health status for their lifetime by reviewing life status,     treatment status and CT scans.   "
51364|NCT02613286|"     This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof     of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial     hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical     hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.   "
51365|NCT02613273|"     This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the     effects of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised resistance     exercise vs. usual care in men with metastatic castration resistant prostate cancer to     determine the safety, feasibility, and tolerance of exercise; quality of life indicators, and     a prognostic score.   "
51366|NCT02613260|"     Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network     and access to care may be limited so novel models of health care delivery are warranted. The     objective of this study is to examine whether a centralized panel management model with     mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC     screening and could be developed and sustained within the typical parameters of     cost-effectiveness and budget impact analyses.   "
51367|NCT02613247|"     Patellofemoral pain syndrome (PFPS) is the most common overuse injury seen in the athletic     population, particularly amongst runners. The standard of care treatment for PFPS is a     comprehensive active rehabilitation program. Eighty percent of patients with PFPS report     improvement in their symptoms with such a program. Unfortunately, the remaining twenty     percent fail to achieve adequate symptom relief with rehabilitation alone. Considering the     enormous number of individuals running for fitness, PFPS represents a significant challenge     to public health as the investigators strive to encourage active living in our society.      A relationship between PFPS and the development of patellofemoral osteoarthritis (PFOA) has     been suggested in scientific literature. Given that intra-articular viscosupplementation     (hyaluronic acid) injections have shown clinically significant symptom improvement in knee     osteoarthritis, and PFPS is likely on the same spectrum, the investigators propose a trial     for therapy-resistant PFPS.      Hyaluronic acid is a naturally occurring molecule found in the synovial fluid of freely     movable joints (such as the knee). It is believed to contribute to lubrication and cushioning     in these joints. The composition of synovial fluid within arthritic joints is altered,     resulting in reduced fluid viscosity and elasticity. One modern formulation of hyaluronic     acid is Hylan G-F 20 (Synvisc-One, Sanofi Canada). This treatment is offered as a single     injection and will be utilized in this clinical trial.   "
51368|NCT02613234|"     The prevalence of epilepsy is about 0.5% to 1% worldwide, with high disability and mortality     rate. The 128-channel electroencephalograph (EEG), combined with BESA dipole localization     method, is able to provide more specific information about the brain activity and find out     the epileptogenic focus. Based on this novel EEG recording method, cathode transcranial     direct current stimulation (tDCS) targeting the epileptogenic focus can be used to decrease     the excitability of the cortex, thus reducing the frequency of seizures. A single-center     single-blinded randomized controlled and open-label extension trial will be carried out to     study the efficacy of 128-channel electroencephalograph combined with BESA dipole     localization method and Intervention on brain waves for epilepsy.   "
51369|NCT02613221|"     To evaluate the combination of panitumumab and TAS-102 in patients with RAS wild-type     metastatic colorectal cancer (CRC) refractory to standard chemotherapy (oxaliplatin,     fluoropyrimidines, irinotecan and anti-VEGF therapy).   "
51379|NCT02613091|"     In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the     drug clemastine has a negative effect on patients' color discrimination, which is the ability     to distinguish different hues and arrange them in the correct order. In an upcoming clinical     trial studying the effect of clemastine on vision outcomes, our lab aims to assess color     visual performance adding assessment of color defectiveness as a clinical endpoint. Color     defectiveness is the ability to see certain colors, and is commonly referred to as     color-blindness. Color discrimination and defectiveness can be related, but do not always     correlate. This study aims to detect the effect, if any, that clemastine has on color     defectiveness in healthy controls, which could confound its use as an outcome endpoint in     future clinical trials relating to clemastine.   "
51457|NCT02612077|"     This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate     progression free survival (PFS) in a real-life setting in participants with metastatic     colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.   "
51381|NCT02613065|"     The purpose of this project is to determine if protein is less likely to create positive     energy balance when added to the diet compared to carbohydrate. To do this, the investigators     will take detailed measurements of participant's baseline metabolic rate to understand their     energy requirements. Then, the investigators will feed participants all their meals for two     weeks, Monday-Friday, and measure their food intake. During one of the week-long feeding     periods, participants will consume a shake made of egg protein that is ~20% of their energy     requirements. During the other week, participants will consume a shake made of carbohydrate     that is ~20% of their energy requirements. Participants will drink the assigned shake at the     beginning of each of their daily three meals, and then they will be offered a 'regular' meal     of unlimited quantity. Participants will not know that the investigators are measuring the     food consumed after drinking the shake. Participants will drink the protein shake for the     first week and carb-based shake for the second week, and vice versa-- depending on the     randomization order. To account for energy expenditure, participants will wear an activity     monitor, an accelerometer. Energy balance, measured as participant energy intake minus energy     expenditure, will be our main outcome for each treatment. However, because participants may     change their behavior if made aware of the true research question, the investigators will     tell participants that the purpose of the study is to see how low fiber and high fiber shakes     affect mood. The hypothesis is that during the week when participants consume the protein     shake, they will remain in energy balance, but during the week of carbohydrate shake     consumption, participants will have positive energy balance.   "
51382|NCT02613052|"     This is a prospective, randomized, controlled study to determine if albumin and propofol or     albumin only will provide superior qualitative contrast enhancement during TEE bubble studies     compared to agitated saline. Each patient will receive three randomized bubble studies     (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated contrast agent.     The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3 mL of propofol (10     mg/mL). Each patient will undergo qualitative review of all 3 bubble studies by 10 different     anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the     time of the surgical procedure, and also with retrospective review of the echo video (~200     studies). A bicaval view will be obtained to record a 20 beat loop for each bubble study.     Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2     minutes after injection will be monitored and recorded.   "
51383|NCT02613039|"     Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To     reduce androgenic side effects of first- and second-generation progestins, several new     progestins derived from progesterone or spironolactone have been developed in the last few     decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed     to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or     glucocorticoid actions.      However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual     dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and     partner's quality of life. Moreover, available data indicate that OC use might increase     adiposity in adolescents and might be associated with central redistribution of body fat in     young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in     clinical anthropometric measurements, including body mass index and waist circumference.      In this context, it would be worth to evaluate the effects of combined OCs on metabolic and     sexual health (sexual desire, arousal, and other parameters of sexual health), body image and     mood.   "
51384|NCT02613026|"     The purpose of this study is to compare the short-term and long-term efficacies and the     safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide     followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.   "
51385|NCT02613013|"     This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral     iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to     control the progression of primary angle closure with multi-mechanism based on the UBM     classification.   "
51386|NCT02613000|"     Importance of gastrointestinal (GI) function in critically ill patients has been recognized,     but until now there is no validated clinical tool to monitor GI dysfunction as part of     multiple organ dysfunction syndrome (MODS). The general aim of current project is to develop     a five grade score (0-4 points) for assessment of GI function similar to SOFA sub-scores used     for assessment of other organ systems. 500 consecutive adult patients admitted to the     intensive care unit will be monitored for gastrointestinal symptoms, intra-abdominal pressure     (IAP) and acute gastrointestinal injury (AGI) grades [1]. In 200 patients from these, plasma     and urinary levels of possible biochemical markers of intestinal injury will be assessed.      Objectives:        -  To determine the prognostic value of gastrointestinal symptoms alone and in combination          with intra-abdominal pressure (IAP), and acute gastro-intestinal injury (AGI) grades in          predicting the ICU-, 28 days and 90 days mortality of adult intensive care patients          (Part A of the study)        -  To describe the blood and urine levels of biochemical markers of intestinal injury in          general cohort of intensive care patients (Part B of the study).        -  To compare the prognostic values of the intestinal-specific plasma parameters (IFABP,          citrulline, ILBP, and D-lactate) with the gastrointestinal symptoms, AGI grades, and the          SOFA score in predicting of ICU-, 28 days and 90 days mortality of adult intensive care          patients (Part B of the study) Study design: prospective, observational, multicenter          study Patient population: All consecutive adult critically ill patients (25 to 50          patients for each study site, 500 patients in total) in need for intensive care          admission during maximum 4 weeks of study period.      Duration of the study: for the individual patient 7 days and follow-up of 90 days Primary     study outcome: 28 and 90 days all-cause mortality Secondary outcomes: ICU and hospital     mortality, ICU length of stay, hospital length of stay, duration of mechanical ventilation,     multiple organ failure as a cause of mortality, plasma and urinary levels of intestinal     fatty-acid binding protein (I-FABP), citrulline, ileal lipid binding protein (ILBP), and     D-lactate in general cohort of intensive care patients.   "
51387|NCT02612987|"     Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It     is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment     of insomnia has been extensively examined in adults, but studies with adolescents are sparse.     The purpose of this pilot study is to assess the feasibility and efficacy of internet-based     cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth     Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome     will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly     assessments will also be made during treatment on primary outcome and a presumed process     variable constructed for the purpose of this trial.   "
51388|NCT02612974|"     This study has been designed to conduct as Randomized comparative clinical study.   "
51428|NCT02612454|"     The primary objective of the study is to assess the long-term safety of dupilumab in     pediatric patients with AD.      The secondary objectives of the study are:        -  To assess the long-term efficacy of dupilumab in pediatric patients with AD        -  To assess the trough concentrations of functional dupilumab in serum and the          immunogenicity in pediatric patients with AD after re-treatment with dupilumab.   "
51389|NCT02612961|"     A long-standing intervention during tracheostomy tube suctioning in acute care settings is     use of saline to loosen and remove respiratory tract secretions, maintain airway patency, and     prevent mucus plugs. Controversy exists regarding safely using saline prior to suctioning for     head and neck cancer and mechanically ventilated patients. To date, all studies had     methodological limitations. In 2013, the clinical consensus statement published by AAO-HNSF     identified a research gap based on lack of strong scientific evidence. A single site,     randomized controlled pilot study will be conducted to evaluate effects of saline     instillation with tracheostomy tube suctioning; test feasibility of proposed methods and     procedures; and ensure proposed outcome variables are measurable and not confounded by     extraneous variables. Institutional review board approval will be obtained before eligible     adult subjects (inpatient and intensive care units) are recruited and consented. Oxygen     saturation and heart rate are primary outcome variables; secondary outcome variables are     mucus plugs and ventilator-associated pneumonias; other demographic data and patient     characteristic variables; and outcome variables on complications and length of stay. Mean,     standard deviation, median, and interquartile range will be calculated for continuous     variables using t-tests to compare pre- and post-assessment scores. Frequencies and     percentages will be calculated for categorical variables using Chi square and Fisher Exact     tests to compare pre- and post-assessment scores. Multiple regression analysis will be used     to control for confounding variables. This study is innovative as the first to recruit both     head and neck cancer patients and mechanically ventilated patients and to measure all major     outcomes of interest in one study. Understanding the effects of normal saline instillation     will enable development of evidence-based guidelines and standardized protocols for     tracheostomy tube suctioning.   "
51390|NCT02612948|"     Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically     ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of     stay.   "
51391|NCT02612935|"     In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an open-label,     12-month pilot study of computerized cognitive training as part of the cognitive wellness     program in order to evaluate (1) the user experience of Lumosity in individuals with MS, and     (2) the efficacy of Lumosity for improving cognitive outcomes in individuals with MS.   "
51392|NCT02612922|"     Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute     uncomplicated influenza.   "
51393|NCT02612909|"     The purpose of this study is to determine a safe and effective dose of IVAC A/H5N1 vaccine     for licensure in Vietnam. The first phase (Phase 2) will compare two doses of the vaccine.     Based on the outcome of the Phase 2, the Vietnam MOH will determine if Phase 3 can be     conducted.   "
51394|NCT02612896|"     Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with     significant economic and public health impacts, occurring primarily in developing countries.     Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host     develops the metacestode larval stage (porcine cysticercosis). However, people can also act     as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC)     when the central nervous system is involved.      The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan     Africa (SSA) have focussed on single control options. It is becoming clear that these     stand-alone options have the potential to reduce the occurrence of the parasite, however     either long term or more integrated efforts seem to be required to reach an elimination     status.      The objective of the current study is to evaluate the cost-effectiveness/acceptability of     elimination (to be achieved on a short term via integrated measures), and control (single     measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in     SSA.      This intervention study will entail an elimination study arm in which multiple control     options are combined (integrated) aiming at the final human host (Mass drug administration     (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a     second study arm a single control option will be carried out (pig treatment). In both study     arms (health) education will be implemented. At baseline and in the final sampling year,     prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in     all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig     sampling will be conducted in the elimination study arm, as well as two-yearly (biennial)     sampling of the pig intermediate host in the control study arm. Additionally, (open ended)     questionnaires and focus group discussions will be administered/held to obtain data on the     cost of pig keeping, T. solium, the interventions and the perception/acceptability of the     proposed control measures to the local communities.   "
51395|NCT02612883|"     Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses.     Compromised microperfusion in the area where the anastomosis is sited likely contributes to     leaks, but until now there has not been an easy and reliable technique to intraoperatively     evaluate microperfusion.      Objectives: To assess the association of intraoperative flux measurement with postoperative     outcome of patients undergoing major abdominal surgery.      Trial design: Prospective observational study. Flux measurement will be carried out using the     moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on     the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and     measurements will be documented after a stable signal has been obtained.   "
51396|NCT02612870|"     Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1     day before surgery, which enables the surgeon to localize the sentinel lymph node during     surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either     1 or 4-6 days before surgery to investigate the concordance with the standard technique.   "
51397|NCT02612857|"     The purpose of this study is to determine how safe and effective IMO-8400 is in adults with     dermatomyositis.   "
51398|NCT02612844|"     This trial is conducted in Europe. The aim of the trial is to investigate the Safety,     Tolerability,Pharmacokinetics (the exposure of the trial drug in the body) and     Pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous     NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes   "
51399|NCT02612831|"     The creatinine clearance will be measured using two consecutive 24 hour urine collections,     with the objective of minimizing errors due to poor quality urine collection.      The GFR will be measured by a reference method, because its estimation from blood creatinine     levels (eGFR) by the MDRD study formula may be confounded by variations in muscle mass, and     therefore creatinine production, following bariatric surgery. The method will remain the same     in each center, and therefore consistent for any given patient, throughout the duration of     the study. The GFR measurements will be performed after stopping any medication blocking the     RAAS, and reducing diuretics for one week, with the introduction or increase of     alpha-blockers or centrally-acting hypotensive agents. If it is impossible to stop     RAAS-blockade (heart failure), the dose will at least be reduced for one week. This     precaution is required to minimize the bias of functional renal insufficiency because the     state of extracellular hydration is difficult to assess in obese subjects. Subsequent     measurements of GFR will be performed in the same way.      The choice of the tracer to measure GFR may vary according to study center. 51Cr-EDTA,     99Tc-DTPA, iohexol or inulin may all be utilized. Because the assessment of edema is     hazardous in extremely obese patients and because kidney disease favors edema formation, the     simplified single injection method and the determination of plasma clearance measurement of     the tracer is not reliable . Only the constant infusion method will be used to measure GFR.     Briefly, GFR will be determined by calculating the glomerular clearance (Cl) from plasma     concentrations (P) and renal excretions per unit of time (UxV) during infusion at a constant     plasma level of the tracer (Cl=UxV/P). The result will be given as mean value of several     consecutive clearances. Because correct urine collection is key for the procedure, seven     collection periods (instead of 5 usually) will be performed for the calculation of the mean     clearance. Bladder catheterization will be used only when it can be anticipated that the     patient will not void satisfactorily. In the last 30 consecutive patients with mGFR below 60     ml/min/1,73m2, this occurred twice and the subjects were 70 and 79 years old. Therefore, this     might occur exceptionably in the study. Raw data from each center will be sent to the     coordination center (Nice) to examine and validate the calculation of mean clearance values.     To that aim, extreme and non-representative clearances will be excluded. At least 3 of the 7     periods will be taken into account to calculate the mean values. For instance, in the last 30     consecutive patients with mGFR below 60 ml/min/1,73m2, investigators considered on average     4.7 periods and obtained a mean non-indexed GFR value of 40,7 ± 2,5 ml/min.      Primary assessment will be performed at one year, as a previous study has already suggested a     significant benefit within this period [66], and because surgery can't be delayed further in     these patients strongly expecting the intervention, but follow-up will be extended to three     years or until the end of the study, in order to document whether the initial benefits of     surgical intervention are maintained.        -  A reduction in the absolute value of measured GFR (mGFR) following bariatric surgery is          expected in the first six months after surgery (M0 - M6). However, the weight loss may          allow an increased in mGFR indexed to body surface area up until M6, and above all          towards M12.        -  the investigators expect a subsequent stabilization of mGFR between M12 and M36 in the          bariatric surgery group, and will seek to measure the anticipated reduction in mGFR in          the control group who remain in a state of glomerular hyperfiltration.      All relevant cardiovascular, metabolic and nutritional parameters necessary to study the     risk/benefit ratio of the intervention will be analyzed.        -  Primary: bariatric surgery slows the progression of chronic kidney disease in the obese.        -  Secondary: bariatric surgery improves survival, cardiovascular prognosis, metabolic,          nutritional and inflammatory parameters, quality of life, and access to transplantation          in the sub-group of patients whose GFR < 20ml/min/1.73m2 at inclusion, and there could          be a chance loss for the patients in delaying surgery by one year.   "
51400|NCT02612818|"     Thus is a longitudinal, prospective, multicentric observational study performed in mainland     France, among a sample of gynaecology surgeons practising at endometriosis expert centres.      The aim of this study is to describe, under real treatment conditions in patients suffering     from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy     surgery on the development of clinical signs in the patients and their fertility at one year.   "
52772|NCT02594787|"     The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or     without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite     (using visual analogue scales) in lean and obese healthy subjects   "
51417|NCT02612597|"     In this study the investigators would like to elaborate on the mechanisms that lead to a     higher insulin sensitivity after exercise training and a lower insulin sensitivity after     bedrest.      The investigators speculate that the concomitant chances in blood volume during training and     bedrest might explain the changed insulin sensitivity because with a changing blood volume     also the dilution space of the glucose will change.      Furthermore, the investigators would like to work on the influence of a changed capacity of     skeletal muscle for glucose uptake and glycogen storage on the glucose sensitivity.      Therefore, A) a bed rest study with healthy untrained subjects and B) a training study with     obese pre-diabetic patients will be conducted.   "
68354|NCT02391051|"     This trial examines the feasibility and toxicity of focal brachytherapy in patients with     low-risk prostate cancer.   "
51405|NCT02612753|"     Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on     social, family and professional lives. Aphasic patients need to be rehabilitated. To date, no     pharmacological treatment being available only speech and language therapy (SLT) can improve     patients, but its efficiency is moderate. Several studies have investigated the link between     the recovery of language and neural reorganization. tDCs, a noninvasive technology for     modulating neural excitability, could potentiate the effects of the SLT. About 25 studies in     literature have described beneficial effects of tDCs coupled with SLT on aphasic patients.     However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical     pathways has never been investigated. That is why the investigator propose to study in real     care conditions how SLT proves more efficient on the recovery of language in a discursive     assessment when coupled with active stimulation than with placebo stimulation.   "
51406|NCT02612740|"     The aim of this study was to evaluate the effect of the use of deproteinized bovine bone as a     filler material of critical-sized (diameter >=20 mm) bony defects derived from the excision     of maxillary and mandibular cysts. 20 patients were considered.      Patients were randomly divided into 2 groups according to the type of treatment: the bone     defect was filled with granules of deproteinized bovine bone (test); no filling material     (control). Clinical parameters were recorded at 7 days, 1, 6 and 12 months after surgery.     Radiological follow up consisted of an orthopantomograph and a CT scan taken at the baseline     (pre-operatory) and 12 months after surgery.      In order to evaluate the difference in percentage of filling of the bone defect between the     two groups, the pre-op and the 1-year radiolucent volumes were evaluated in the CT scans.   "
51407|NCT02612727|"     At present, much of sub-Saharan Africa, including Nigeria and other resource-limited     countries, are without ready access to CPT, due to factors including the lack of PT devices,     which are expensive and require consistent electric power to operate. NHB is a significant     cause of neonatal morbidity and mortality, but preventable when appropriate treatment is     initiated. We have shown that FS-PT is safe and efficacious for the treatment of     mild-moderate NHB. The major goal of this study is to demonstrate that FS-PT is efficacious     for the treatment of significant/severe NHB, generally defined as TB of ≥12-14mg/dL (but more     specially as defined as needing phototherapy per American Academy of Pediatric 2004     guidelines). It will be done at 3 sites in Nigeria (2 in Lagos, Nigeria and 1 in Ogbomoso,     Nigeria). The rationale for conducting the study is that in Nigeria, and other countries that     cannot afford effective commercial light devices and/or have no reliable electric power to     operate them, filtered sunlight phototherapy might offer a safe and effective treatment for     neonatal jaundice.   "
51408|NCT02612714|"     Statins may decrease serum testosterone levels via decreasing cholesterol. This longitudinal     study detected the effects of rosuvastatin on free testosterone levels and sexual function in     men with type 2 diabetes.      Methods:      Investigator enroll 150 men with type 2 diabetes and hypercholesterolemia. Biochemical     assessments include serum total cholesterol (TC), low-density lipoprotein (LDL), high-density     lipoprotein, triglyceride, prolactin, thyroid-stimulating hormone, luteinizing hormone,     follicle stimulating hormone, total testosterone and serum sex hormone binding globulin     (SHBG). All parameters are measured before statin treatment, after 6 months of statin     treatment and 6 months after discontinuing statin treatment. Scores of the sexual health     inventory for men (SHIM) are also evaluated.   "
51409|NCT02612701|"     E-cigarettes deliver nicotine by creating an aerosol of ultrafine particles. Many questions     remain about the size and composition and especially about the potential toxicity of these     particles. Thus, a key unanswered question—and the research question proposed—is whether     e-cigarette aerosol triggers the same acute impairment in coronary microvessel function as     does conventional cigarette smoke, which delivers a very well-defined exposure to fine     particles and many fold greater exposure to toxic (combustion) products including volatile     organic compounds (such as acrolein) that have been implicated in the pathogenesis of     tobacco-related coronary disease.      Because the effects of nicotine on the human coronary microcirculation remain incompletely     defined—with multiple potential vasodilator and vasoconstrictor actions each of which may     vary by dose—we will determine the comparative effects of conventional cigarette smoke     against e-cigarette aerosol with no nicotine, with low-dose nicotine, and with high-dose     nicotine.   "
51410|NCT02612688|"     This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP)     Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH     facilities (intervention arm n=119; control arm n=241) within two NH health care systems:     Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP     Video Program, while the control NH facilities will follow their usual ACP procedures. The     trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations,     advance directives, and hospice use in the intervention vs. control NHs.   "
51411|NCT02612675|"     This will be a randomized, cross-over study of two oral nutrition supplements in individuals     with Type 2 Diabetes.   "
51412|NCT02612662|"     This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and     pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male subjects at increasing     single doses.   "
51413|NCT02612649|"     The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD     Tablets in post-marketing medical practice and to examine the status of treatment compliance.   "
51414|NCT02612636|"     Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being,     and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory     disengagement from the external environment. Critically ill patients experience poor sleep     quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for     mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many     physiological, psychological and environmental factors contribute to the incidence of sleep     disruption for the ICU patients. The primary physiologic factors documented in the literature     are pain, medications and illness.The primary psychological factors documented in the     literature are stress and worry. Environmental factors include noise, patient care activities     and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of     effective interventions like use of ear plugs and eye mask on decreasing light exposure and     promoting sleep in ICU patients.   "
51418|NCT02612584|"     For correct of presbyopia, in this study, the investigators have recruited subjects who aged     45~65 years with presbyopia and do not have any other ocular disease(ex, ocular surface     disease, corneal dystrophy, retinal disorders, etc.). All participants will underwent     ophthalmic examination including manifest refraction, uncorrected distance visual acuity     (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA),     corrected near visual acuity(CNVA), Goldmann visual field test, depth of focus Contrast     sensitivity test, slit-lamp examination, topography with scheimp flug device(OCULUS pentacam     ®) OSDI(ocular surface disease index) and Questionnaire about visual function and ocular     symptoms. Apply pinhole soft contact lens (eyelike NoanPinhole ® , seoul, south Korea, Koryo     Eyetech) on non-dominant eye of participants and/or soft contact lens for distance vision on     dominant eye of participants. The investigators recommend use of pinhole contact lens at     least 3 hours in a day for 1 week. And, participant will underwent the all ophthalmic     examination same above 2 weeks after first apply of pinhole contact lens. The investigators     will compare ophthalmic parameters mentioned above before and after wearing pinhole contact     lens and evaluate the efficacy and safety of pinhole soft contact lens for correcting     presbyopia.   "
51419|NCT02612571|"     The purpose of the present study is to compare rates of glaucomatous optic neuropathy in     professional wind versus non-wind instrument players in the Philadelphia Orchestra. A     secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind     instrument players under variable playing conditions.   "
51420|NCT02612558|"     The purpose of this study is to evaluate whether fostamatinib is safe and effective in     treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).   "
51421|NCT02612545|"     Background:      Malaria is an illness caused by a parasite that enters people s bodies when a mosquito bites     them. It can cause fevers, headaches, body aches, and weakness. If not treated, it can make     some people very ill. Malaria can be cured. A mix of 2 drugs that has worked well in the past     is not working as well in some parts of Cambodia. Researchers want to see if a mix of 3 drugs     works better and is safe.      Objectives:      To see if a 3-drug mix can be used to treat malaria in areas where a 2-drug mix is less     effective.      Eligibility:      People aged 2 65 years with mild malaria in Pursat, Preah Vihear, and Ratanakiri Provinces in     Cambodia.      Design:      Participants will be screened with medical history, physical exam, urine and blood tests, and     an electrocardiogram (ECG). For this, electrodes will be placed on their skin to check their     heartbeat.      Participants will spend about 5 nights in the hospital. They will have physical exams and     will complete symptom questionnaires daily. They will give blood periodically throughout     their stay. For this, a thin plastic tube is placed in an arm vein for the first day, and     blood draws using a needle are done after that.      Participants will get either a 2-drug mix or a 3-drug mix for 3 days. They will have 2 ECGs     each day of receiving the drugs.      Participants will have follow-up visits once a week over 5 weeks. At these visits, they will     have a physical exam and have blood taken. If they have any signs of malaria, they will be     re-treated.      The study will last up to 42 days.   "
51422|NCT02612532|"     The Lung Cancer Indicator Detection (LuCID) study investigates the the diagnostic accuracy of     FAIMS for diagnosis of lung cancer by analysis of exhaled Volatile Organic Compounds.   "
51423|NCT02612519|"     Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with     recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the     Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. All     patients will receive medical care for cirrhosis and ascites according to the institution's     standards of care. Standard of care may include, but is not limited to the administration of     diuretics, paracentesis and consideration for orthotopic liver transplantation.   "
51424|NCT02612506|"     To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical     pharmacokinetics in healthy volunteers.   "
51425|NCT02612493|"     Obesity is the indication for bariatric surgery in type I diabetes. Interestingly postsurgery     the patients improve remarkable in their need for insulin, not only in the daily total     insulin dosage but also in the dosage of IU per kg.   "
51426|NCT02612480|"     Rationale:      In patients suffering a myocardial infarction the P2Y12 receptor antagonists prasugrel and     ticagrelor improve outcome and prognosis compared to clopidogrel. Moreover, ticagrelor lowers     mortality from pulmonary infections and sepsis, which cannot solely be explained by its     platelet-inhibiting effect. An effect on the inflammatory response in the setting of acute     myocardial might underlie this phenomenon and if substantiated support a novel beneficial     mechanism of the new the P2Y12 receptor antagonists.      Objective:      To study whether ticagrelor, added to acetylsalicylic acid, modulates the inflammatory     response to the administration of lipopolysaccharide (LPS) in humans in vivo, and to compare     this effect with the P2Y12 antagonist clopidogrel.      Study design:      Prospective randomized placebo-controlled trial, according to a PROBE design (prospective     randomized open blinded-endpoint study).      Study population:      Forty healthy male volunteers aged ≥ 18 and ≤ 35 years. Intervention (if applicable):     Participants will be randomized to receive either placebo (twice daily), acetylsalicylic acid     (80 mg once daily, after a loading dose of 160 mg) + placebo (once daily), acetylsalicylic     acid (80 mg once daily, after a loading dose of 160 mg) + ticagrelor (90 mg twice daily,     after a loading dose of 180 mg) or acetylsalicylic acid (80 mg once daily, after a loading     dose of 160 mg)+ clopidogrel (75 mg once daily, after a loading dose of 300mg).      Main study parameters/endpoints:      Endpoints: area under the curve of the proinflammatory cytokines TNF-alpha, IL6, IL-10, IL1ra     IL-8, IL-1β, MCP-1 MIP-1a, MIP-1b en IFN; peak concentrations of the various cytokines;     plasma concentration of HMGP1; platelet-monocyte complex formation and markers of platelet     function; plasma concentration of adenosine.   "
51427|NCT02612467|"     Background Studies in the United Kingdom find the stratified care model of the STarT Back     Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients.     However, considerations on differences in health care and social systems across countries are     required before taking steps towards any recommendations of implementing stratified care into     other health care services.      Objective To investigate the effectiveness of the stratified care model of the SBT, when     embedded into the regional disease management programs on LBP in primary care as compared to     current best practice care.   "
51429|NCT02612441|"     Chinese Acupuncture can improve the motor ability of patients after having first acute     ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in     minimum receiving number of 3 Acupuncture treatments.      The accepted treatment on cerebral vascular accident (CVA) is focus on two lines: the first     is the treatment when the stroke occurs, and the second is prevention from having more     cerebral vascular accident in the future.      In the first accepted treatment line, the only medicinal measure that stand up in critique of     organized researches, is Tissue Plasminogen Activator (TPA), and there is Short and limited     time after the CVA occur that it can be used. Also (TPA) can be used only on part of the     patients with specific defined criterions.      The aim of this study is to add a new accepted treatment method that appointed to improve the     results of acute ischemic stroke by Chinese Acupuncture. The written works on this topic is     unambiguously.   "
51430|NCT02612428|"     The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to     overall survival of subjects with a clinical diagnosis of alcohol-induced liver     decompensation (AILD) through at least Study Day 91.      The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a     chi-squared test.   "
51431|NCT02612415|"     A feasibility study to inform the design and conduct of a randomised controlled trial of high     flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive     respiratory support in critically ill children   "
51432|NCT02612402|"     A smartphone app will be installed on smartphones of patients with type 2 diabetes or     hematologic malignancies that do not exercise. The app will send SMS messages to encourage     exercise. The exercise will be quantified by the smartphone accelerometer and clinical data,     including HbA1c will be collected.   "
51433|NCT02612389|"     This study will explore the a Qigong based exercise intervention, here referred to as     Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive     pulmonary disease (COPD) and its co-morbidities. It tests the hypothesis that MM will have a     beneficial effect on COPD in FA, particularly on functional ability, respiratory symptoms,     affective state, inflammation, and autonomic imbalance. If the hypothesis is correct, MM     could be rapidly and inexpensively taught to FA with COPD and other COPD patients to slow     degeneration and improve quality of life.   "
51434|NCT02612376|"     This study plans to establish a large bank of blood, cerebral spinal fluid (CSF), imaging,     and clinical data. These data and samples will be used for future research into the causes of     Alzheimer's disease (AD), Down Syndrome (DS) and other diseases that cause thinking and     memory problems. This future research will also study how treatments for these diseases work.     This research may help develop new treatments for some diseases of the nervous system and     help understand these diseases better.   "
51435|NCT02612363|"     The investigators will conduct a prospective, single-center, randomized, double-blinded,     controlled study to investigate the effect of early goal directed sedation on     microcirculation in early septic shock patients.   "
51436|NCT02612350|"     Pathway Genomics Corporation (Pathway Genomics), a San Diego, California company, is involved     in the development and validation of new molecular diagnostic assays for the analysis of     circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the plasma-derived DNA     (cell-free DNA or cfDNA) in order to identify specific variants (mutations) in cancer driver     genes. The purpose of testing for mutations in ctDNA is to detect and monitor cancer. All     cells shed DNA into the bloodstream. Finding cancer-associated mutations in the cfDNA may     lead to early detection of cancer in an otherwise apparently healthy (i.e. asymptomatic)     individual or may allow the healthcare provider to more effectively monitor and treat a known     cancer patient. The analysis is performed using a polymerase chain reaction (PCR)-based     methodology where oligonucleotides are designed to target specific mutations in designated     genes of interest followed by next generation deep sequencing of the amplified targets.     Evaluation of the performance of these assays for screening for cancer in asymptomatic     subjects is essential for the clinical validation of the use of these assays. The specific     aim of this protocol is to obtain relevant human blood samples from individual subjects at     higher than average risk for the development of cancer due to age, heredity, or environmental     or toxic exposures for use in the statistical analysis of this method as an adjunct screening     test for the potential presence of cancer.   "
51437|NCT02612337|"     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of     Meniere's disease.   "
51438|NCT02612324|"     The purpose of this study is to determine the impact Pono Choices has among youth for teen     pregnancy and STI prevention measures such as: initiation of sexual activity; engagement in     high risk sexual behaviors; knowledge of pregnancy and STI prevention; attitudes toward     healthy sexual behaviors; skills in managing relationships and choices; and intentions about     future sexual activity.   "
51439|NCT02612311|"     This study evaluates the combination of ublituximab, a novel monoclonal antibody, and     TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and     compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.   "
51440|NCT02612298|"     The purpose of this study is to compare the efficacy and safety of Arotinolol Hydrochloride     and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in     patients with essential hypertension. To provide evidence for hypertension treatment.      A group: Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. B group: Metoprolol     succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.   "
51442|NCT02612272|"     This study will compare the efficacy of intra-articular betamethasone injection to     intra-articular ketorolac injection for symptomatic treatment of knee osteoarthritis in an     equivalence study using a double-blinded, randomized, controlled design. Patients will be     recruited from orthopaedic clinics at St. Luke's University Health Network. A total of 448     patients will be recruited (224 in each group) to receive an administration of an     intra-articular betamethasone or ketorolac injection. The primary outcome is change in pain     as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)     score. Secondary outcomes include Knee Injury and Osteoarthritis Outcome (KOOS) and Knee     Outcome Survey - Activities of Daily Living (KOS-ADL) scores and physical exam findings.     Statistical analyses include repeated measures analysis of variance (ANOVA) (primary outcome)     and selected ANOVA and nonparametric tests as deemed appropriate (secondary outcomes), with p     < .05 denoting significance for all comparisons, and no adjustment for multiple testing.   "
51444|NCT02612246|"     The purpose of this First-in-Human study is to evaluate the safety and tolerability after     single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo. Also,     the safety and tolerability of multiple ascending oral doses of GLPG1972 given to healthy     subjects daily for 14 days compared to placebo, will be evaluated.      Furthermore, during the course of the study after single and multiple oral dose     administrations, the amount of GLPG1972 present in the blood and urine (pharmacokinetics)     will be characterized.      The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential     of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored     as well.      During the course of the study after multiple oral dose administrations, the effect of     GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.   "
51445|NCT02612233|"     Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis     of the hands affects millions of people and is a major cause of hand disability and pain.     Despite this, there are currently no treatments that delay or halt the development of     osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an     important factor to consider in the treatment of this condition. Treatments for pain in     osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as     paracetamol. However, most people with osteoarthritis still have pain despite these     treatments.   "
51446|NCT02612220|"     The present randomized controlled trial evaluates the efficacy and safety of BioFoam®     Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical     agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but     also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of     postoperative complications.      The primary objective of this trial is to show that time-to-complete hemostasis can be     reduced using BioFoam® Surgical Matrix as compared to the conventional approach.   "
51447|NCT02612207|"     The aims of this project are to validate the performance of the miniaturized and modernized     hematofluorometer that measures bilirubin capacity into a product and is suitable for     operation in various point of care environments when encountering confounding direct     bilirubin, to complete the development of easy to use sample handling disposables, and to     verify the performance of the system for samples from a specified population of neonates.   "
51448|NCT02612194|"     Following informed consent and registration, subjects will undergo tissue pre-screen     eligibility screening. Tumor specimens from potential subjects will then undergo c-MET and     RON expression characterization. Eligible subjects will then undergo treatment eligibility     screening and then be enrolled into available open molecularly defined cohorts. If at least     one response is observed within a cohort, it will be considered for expansion with additional     subjects enrolled. The cohort showing the highest response rate will be given highest     consideration, as determined by the Sponsor-Investigator. Trial accrual is anticipated to     occur over two years with 21 subjects enrolled during the first stage (7 in each cohort) with     the opportunity for an additional 25 to be enrolled if a cohort is expanded. Subjects     enrolled will follow the same procedure and treatment schedule, regardless of cohort     assignment.   "
51449|NCT02612181|"     The investigators preliminary study showed that dexmedetomidine might improve     microcirculation in septic shock patients. To test this effect, the investigators will     conduct double-blinded study.   "
51450|NCT02612168|"     Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to     detect melanoma in pigmented lesions, compared to gold standard histological determination.   "
51451|NCT02612155|"     This study will test the safety and efficacy of an infusion of a baby's own (autologous)     umbilical cord blood as compared with placebo in babies born with history and signs of     hypoxic-ischemic brain injury.   "
51452|NCT02612142|"     35 participants diagnosed with major depressive disorder were randomized in 3 intervention     groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no     intervention (control group; NI). The intervention length was 10 consecutive days. In groups     1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day.     Depressive symptoms were assessed the day before the beginning of intervention and the day     after the end of intervention for participants of both groups.   "
51453|NCT02612129|"     A prospective, randomised, double-blind, placebo controlled therapeutic study in patients     with confirmed diagnosis of NiemannPick disease type C (NPC).      The purpose of this study is to assess the efficacy and safety of arimoclomol (compared to     placebo) when it is administered as an add-on therapy to the patient's current prescribed     best standard of care; patient's standard of care may, or may not, include miglustat.   "
51454|NCT02612116|"     The purpose of this study is to evaluate the differences in pharmacokinetics and     pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the     drug administration in patients with unstable angina pectoris.   "
52206|NCT02602210|"     The main goal of the study is to investigate the clinical relevance, efficacy and safety of     treating hypotensive cirrhotic patients with suspicion of sepsis and on vasopressors with     low-dose hydrocortisone in order to reverse hemodynamic instability and organ failure and to     decrease mortality.   "
51455|NCT02612103|"     Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel     diseases (IBD). At the time of diagnosis it is not possible to predict the course of the     disease, which can range from a few flares in a lifetime to uncontrollable disease leading to     hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and     prognostic tools.      In chronic inflammation diseases there is an excessive turnover of the extracellular tissue.     Tissue is broken down to small fragments and released into the circulation. Changes in the     amount of these fragments in the blood may provide information on the damage and quality of     the affected tissue and may therefore act as objective measure of disease burden and severity     - a so called biomarker.      The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal     survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The     patients are followed for up to 1 year. Changes in biomarker are correlated to standard     markers of inflammation during active disease and remission.      Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut     of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of     treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.   "
51459|NCT02612051|"     GSK3008348 is an investigational drug, being developed by GlaxoSmithKline Research and     Development Limited (the Sponsor, a pharmaceutical company based in the UK) for the treatment     of Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare and poorly understood disease that     causes scarring of the lungs. The main symptoms are shortness of breath and a dry cough.     Symptoms generally worsen over time and in some subjects may prove fatal. The cause of IPF is     unknown.      This is a First Time in Human, Phase 1, 3-part study which is being carried out on behalf of     the Sponsor by Quintiles. The primary purpose of Part A is to examine the safety and     tolerability of single nebulised (a medicated spray) doses of GSK3008348 following inhalation     in healthy volunteers. The secondary objective is to determine how and at what rate the body     absorbs, distributes, breaksdown and eliminates the drug.      Parts B and C of this study will be in-patients with Idiopathic Pulmonary Fibrosis (IPF). The     purpose of Part B and C is to examine the safety and tolerability, and how much of the drug     binds to its target, following single nebulised (a medicated spray) doses of GSK3008348     following inhalation in patients with Idiopathic Pulmonary Fibrosis (IPF). The secondary     objective is to determine how and at what rate the bodies of these patients absorbs,     distributes, breaksdown and eliminates the drug.      The total duration of Part A will be 65 - 87 days, Part B 62 days and Part C 43 days.   "
51460|NCT02612038|"     Obstructive sleep apnea (OSA) is inherently site-specific. In a physiological controlled     intervention study, the investigators seek to determine whether applying expiratory     resistance can acutely improve ventilation and sleep in patients with expiratory flow     limitation (EFL).   "
51461|NCT02612025|"     The purpose of this study is to determine whether combined endurance and resistance training     can improve muscle strength in children and adolescents with cancer during the intensive     treatment phase.   "
51462|NCT02612012|"     This study is designed to evaluate the feasibility and safety of axillary radiotherapy for     early stage breast cancer with limited positive sentinel lymph nodes.   "
51463|NCT02611999|"     The investigators' study seeks to explore the impact of price information on physicians'     ordering behavior and care quality. The investigators will evaluate the impact of the     physician price transparency initiative at Atrius Health (ATRIUS) on rate of overall     procedure and test orders, clinically inappropriate orders, and appropriate orders.     Ultimately, this study will help stakeholders understand the degree to which price     information can help improve the value of healthcare.   "
51464|NCT02611986|"     A randomized controlled prospective study of laryngoscopy and intubation success comparing     direct laryngoscopy and the McGrath® Mac videolaryngoscope.   "
51465|NCT02611973|"     The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes     less useful once patients have achieved a hematologic response (HR) (modified by amendment     1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially     in elderly patients.      Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio     of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological     response (modified by amendment 1/03/2017) on Hydroxyurea.   "
51466|NCT02611960|"     This is a study of pembrolizumab (MK-3475) versus standard of care (SOC) treatment     (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic     nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either     pembrolizumab or Investigator's choice of standard treatment.      The primary study hypothesis is that pembrolizumab treatment prolongs progression-free     survival (PFS) and overall survival (OS) when compared to SOC treatment.   "
51467|NCT02611947|"     Various indexes have been proposed to quantify both pulmonary emphysema and airways disease     on chest CT scans. It is unknown whether these indexes should be consider in absolute values     or as compared to predicted normal values. The purposes of the present study is thus : a) to     measure these indexes at CT in healthy volunteers; b) to investigate their relations with     gender, height and weight.   "
51468|NCT02611934|"     Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest     Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine     whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes     (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated     with better clinical outcomes as compared with therapy without MTH.   "
51470|NCT02611908|"     The purpose of the study is to investigate whether the combination of obinutuzumab and     ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL     that is not responding or no longer responding to treatment with ibrutinib alone. The study     will evaluate whether this regimen can reduce the amount of cancerous cells in the body.     Subjects will be treated with ibrutinib at a dose of up to 840 mg a day by mouth, as well as     obinutuzumab infusions. Although both of these agents are approved by the FDA for the     treatment of CLL or SLL, the combination and the dosing schedule of ibrutinib are considered     experimental.   "
51471|NCT02611895|"     There is a theoretical possibility of a complete suppression of HIV viral replication,     subject to the use of highly active associations of more than 25 antiretroviral drugs     currently available and good treatment adherence. But a key question remains: whether it can     persist viral replication low noise HAART, since several arguments suggest a subclinical     escape of the virus to HAART at least in some individuals. The technique proposed in this     research consists of the detection and quantification of the linear viral cDNA intra     cytoplasmic, as persistent novo infection marker in order to highlight the subclinical     replication active in treatment of HIV-1 and consider an optimized therapeutic management of     patients.      Main objective : Comparing the frequency of patients infected with HIV and treated     effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA     into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker     novo persistent, among patients with a therapeutic regimen contains or not the viral     integrase inhibitor raltegravir.      Secondary objectives        -  To evaluate the frequency of patients infected with HIV and treated effectively with the          HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood        -  Evaluate the causes of persistent infection in de novo virological responders to          treatment with ART: presence of the HIV genome encoding strains resistant to treatment          ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir ,          pretreatment level of plasma HIV RNA, total duration of ART        -  Assess the impact of persistent novo infection virological responders: cell activation          CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T          naïve / memory cells cells, the presence of transient increase viremia, residual viremia          levels        -  Identify virological responders may benefit from treatment intensification   "
51472|NCT02611882|"     The investigators are imaging patients with prostate cancer using a new PET imaging agent     (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in     patients with high risk disease prior to prostatectomy, patients with biochemical recurrence     and patients with castrate resistant prostate cancer.   "
51473|NCT02611869|"     120 consecutive patients with paroxysmal AF, slated for PV isolation, will be randomly     assigned to RF or cryoballoon ablation (in a 1:2 allocation scheme). Real-time 3D     echocardiography (RT3DE) will be performed before the ablation procedure and 1 month     post-ablation. The RT3DE datasets will be stored digitally and quantitative analyses will be     performed off-line at a core echo laboratory. Quantification of left atrial volumes will be     performed and left atrial functional quantification will be performed by calculating the     following indices: Left atrial ejection fraction, Active atrial emptying fraction, Passive     atrial emptying fraction, Atrial expansion index. All patients will be hospitalized for 48     hours post-ablation. Blood samples will be obtained at 12-hour intervals to measure troponin     T with a high-sensitivity assay, as well as other biochemical parameters.   "
51474|NCT02611856|"     The twin pregnancies monochorionic are specifically explained to two main types of     complications: the anomalies of the embryo affecting a symmetry and in particular the median     line on one hand and malformative sequences of vascular origin on the other hand. This last     category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a     division of the foeto-placentary circulation between both twins through the pooling of     certain placentary cotyledons. The latter are then vascularized by an arterial and venous     foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results     from it an imbalance moderate but very early hemodynamic which is going to return a     hypovolume twin (the donor) and its plethoric co-twin (the recipient).      These anomalies in utero could not only have consequences during the fetal life, on the born     weight and the later development of newborns, but also on the organization and the     functioning of a whole series of physiological systems. So these anomalies of the pregnancy     could have also consequences which exceed by very far from the perinatal period, by favoring     the development of the atheroma, the high blood pressure, the resistance in the insulin, and     many other metabolic and endocrine functions were known for their importance in human     pathology.      For these reasons the investigators suggest estimating the tensional, cardiac and metabolic     status of children ex-transfusers and of children ex-transfused into the age of 5 years. This     if study leans on the big originality of the physiopathological model of TTTS in which the     children present the peculiarity to have an identical genetic and postnatal status and a     different prenatal environment.      The follow-up of these children should allow:        -  To understand better the postnatal impact anomalies on these children in the course of          pregnancy        -  To anticipate and thus to improve their care in case of appearance of biological or          clinical signs   "
51475|NCT02611843|"     Veterans who served in Iraq and Afghanistan have high rates of co-morbid PTSD symptoms and     hazardous substance use (HSU). Evidence-based treatments for these problems are available in     VA specialty clinics, but multiple barriers lead to low utilization of these treatments.     Novel treatment approaches are needed. Previous research supports that 1) primary care-mental     health integration (PC-MHI) services are associated with increased treatment engagement, 2)     technology-based interventions are well accepted by Veterans and are more effective when     delivered with professional support, and 3) Veteran peer services are associated with     improved treatment engagement, patient motivation, and overall functioning. This study will     add a Peer-Support component to an existing Web-based Cognitive Behavioral Treatment (CBT)     for PTSD and HSU called Moving Forward. Preliminary data analyses from our NIAAA-funded trial     indicate that participants who used Moving Forward more had larger reductions in PTSD     symptoms. Qualitative feedback supports that Veterans want interpersonal interactions while     receiving treatment and need help engaging in the treatment more fully. Therefore, this pilot     study will investigate if adding peer support to Moving Forward improves patients outcomes. A     randomized controlled trial (N=30) comparing Moving Forward to Peer-Supported Moving Forward     will be conducted. The peer support component will consist of semi-structured brief sessions     conducted weekly for the 12 weeks of study treatment by a VA-certified peer support     specialist. Peers will receive study-specific training and weekly supervision from clinicians     that are part of the study staff. Primary outcomes will include process outcomes (treatment     engagement, patient satisfaction) and clinical outcomes (PTSD symptoms, alcohol and substance     use, quality of life).   "
51476|NCT02611830|"     The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab     SC) maintenance treatment in participants with moderately to severely active ulcerative     colitis (UC) who achieved clinical response following administration of vedolizumab     intravenous (vedolizumab IV) induction therapy.   "
51477|NCT02611817|"     The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab     SC) as maintenance treatment in participants with moderately to severely active Crohn's     disease (CD) who achieved clinical response following administration of vedolizumab     intravenous (vedolizumab IV) induction therapy.   "
53965|NCT02579213|"     electronic nose- the tiny sensors, will smell and detect the changes in the sample of     abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.   "
51478|NCT02611804|"     To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test     product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the     clinical equivalence and to show that the efficacy of the 2 active formulations is superior     to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald     scalp.   "
51479|NCT02611791|"     OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative     radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the     sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29     sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study     group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a     week. The instruments of evaluation were photo (taken before the first session and eight days     after the last session), which were evaluated by the patient and by three health professional     (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged,     satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female     Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The     patients' satisfaction and the health professionals' evaluation were analyzed by the     chi-squared test and by binomial comparison inter-group and intra-group.   "
51480|NCT02611778|"     The purpose of this study is to determine the efficacy and safety of the biosimilar     ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular     degeneration.   "
51515|NCT02611310|"     This is a prospective, national, multicenter, non-interventional study designed to enroll     participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior     to registry enrollment. These participants will be prospectively followed for at least 5     years after study enrollment to evaluate their anti-cancer treatments. Data on participants'     previous anti-cancer treatments for breast cancer will be collected retrospectively at study     entry.   "
51481|NCT02611765|"     Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new     cases per year. Due to shared transmission route and risk factors, co-infection with syphilis     and Human Immunodeficiency Virus (HIV) is not uncommon. Several studies have evaluated the     response to syphilis treatment in HIV-infected patients. They support the claim that patients     with HIV have a slower decrease in syphilis antibody titers, and that they may progress to     neurosyphilis in earlier stages.      The Center for Disease Control and Prevention's Sexually Transmitted Disease Treatment     Guidelines has advocated treating HIV-infected patients who have primary, secondary syphilis     or early latent syphilis with the same doses of penicillin as for HIV-uninfected patients     (single dose of 2.4 million units of benzathine penicillin G). The investigators designed a     randomized controlled trial in order to compare the efficacy of three- versus single-dosed     regimens of intramuscular benzathine penicillin G (BPG) for the treatment of early syphilis     in HIV-infected patients.   "
51482|NCT02611752|"     Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and     duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in     patients with moderate or severe opioid use disorder.   "
51483|NCT02611739|"     Pain is a frequent and significant problem related to cancer-directed treatment in children.     Children with cancer often cite needle procedures as the most distressing experience caused     by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is     capable of facilitating distraction and reducing distress during childhood immunizations. Our     research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port)     for effectiveness testing in a future RCT (measured as implementation outcomes) and (2)     determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes),     compared to standard medical care.   "
51484|NCT02611726|"     Rationale for conducting the experiment: Israel performed IVF treatments since 1980.      Although ART (Advanced Reproductive Treatments) have evolved over the years implantation and     pregnancy rates have not met the expectations yet. Success rates of fertility treatments are     about 15-18% (clinical pregnancy rates =CPR). As a result additional methods (clinical,     technological and complimentary) have been tried to improve the CPR.      In some reviews the effects of acupuncture practice during fertility treatments showed     certain benefits, including pain relief and relaxation. Unfortunately those trials were not     randomized and lacked methodological rigor.      The aim of this study is to evaluate the effect of acupuncture on pain, anxiety, and CPR of     women undergoing IVF as compared to standard care alone.   "
51485|NCT02611713|"     This study is a non-interventional post-marketing observational study (PMOS) of participants     with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical     setting. Effectiveness of treatment will be collected with physician and     participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the     start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal     extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6     months thereafter up to 36 months.   "
51486|NCT02611700|"     This clinical study is designed as a phase 3,multicenter, double-blind, randomized,     controlled study,to evaluate the efficacy and safety of nimotuzumab combined with     paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic     esophageal squamous carcinoma.   "
51487|NCT02611687|"     The purpose of this multicenter double blind study is to assess efficacy and safety of     Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.   "
51488|NCT02611674|"     The primary objectives of the study are to estimate and rank-order the longitudinal     standardized mean changes over 6 months and over 12 months, for a set of novel outcome     measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to     identify measures that are more sensitive to disease progression than Amyotrophic Lateral     Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study     are: To evaluate the test-retest reproducibility of each outcome measure; To determine     correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month     changes in ALSFRS-R and survival; To assess correlations between/among the various measures;     To obtain biological samples in order to identify molecular correlates to the clinical     measures and to further characterize previously identified and novel molecular biomarkers of     disease progression for incorporation into future clinical studies.   "
51489|NCT02611661|"     The rationale for this design is initial utilization of a standard-of-care therapy for mCRC     (radioembolization) with a dose-calculation algorithm that has been verified as predictive     for treatment response. Prediction of treatment failure will enable the proposed subsequent     locoregional therapies which were selected based on safety profiles and feasibility. While     the goal of this study is assessing feasibility and safety of this approach, the end goal of     improving overall patient outcomes by improved hepatic tumor control.   "
51490|NCT02611648|"     This study is investigating the most effective way to sterilize duodenoscopes (scopes) used     at Beth Israel Deaconess Medical Center (BIDMC). Right now, BIDMC uses the standard method of     high level disinfection to sterilize scopes. Because infections have been passed by scopes at     other institutions in the U.S., the investigators are exploring whether or not adding two     different sterilization processes will reduce this risk of contamination.      Bacteria may be passed from a patient's intestines to the scope. Or, if the scope is     contaminated, bacteria may be passed from the scope to the patient. In order to understand     how bacteria are passed, the investigators will be taking samples of the patient's intestinal     bacteria to compare to the bacteria, if any, found on the scope.   "
51491|NCT02611635|"     The main research question of this patient survey is to assess AF patients' preferences     associated with different attributes which describe the different available anticoagulation     treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).      VKA (Waran®) will be compared to Rivaroxaban.   "
51516|NCT02611297|"     The purpose of this study is to evaluate the the diagnostic yield and safety of     transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.   "
51605|NCT02610127|"     The overall objective is to enroll patients with acquired hemophilia A (AHA) who are     prescribed and treated with Obizur, to assess safety, and to describe factors related to     safety, utilization and effectiveness in a real-world setting.   "
51492|NCT02611622|"     Patient satisfaction is an important metric currently used to rate quality of healthcare in     hospitals. Maximizing patient satisfaction scores is therefore significantly beneficial to     any hospital establishment. Recent studies have shown patient satisfaction depends on     multiple factors, including patient involvement in treatment decision-making processes and     patients' knowledge of treatment options. Internal review of departmental patient     satisfaction survey scores revealed deficits in the aforementioned areas of patient     satisfaction, with the domains of how well concerns were addressed, explanation of tests     and procedures and effort to include patients in decisions having the lowest scores on     patient satisfaction surveys. This highlights the gap in patient satisfaction that the     Otolaryngology department seeks to improve on, so as to maximize patient satisfaction, and in     turn, the quality of healthcare provided.      The aim of this study is to assess the improvement in patient satisfaction scores that can be     obtained by incorporating LUMA ENT™, a disease-specific multimedia patient education     software, into the treatment decisions for thyroid disorders. LUMA ENT™ is a leading patient     education software that provides visual anatomic animations of disease processes, disease     progression and treatment options to improve patients' knowledge. Thyroid disorders have been     chosen for study due to their high frequency of occurrence in the patient population and     generalizability to a wide medical audience.      The investigators will perform a single-blinded randomized-controlled study of patients     visiting the physician practices of the Department of Otolaryngology for management of     thyroid disorders. Participants will be randomized into control and intervention groups. Upon     completion of the routine physician-patient clinical encounter, the intervention group will     view a 5- minute LUMA ENT™ video discussing their specific thyroid condition, its natural     progression history, and treatment options. They will have an opportunity to ask the     physician any further questions that arise from viewing the video. The control group will not     view the LUMA ENT video. Patient satisfaction surveys will then be provided to both groups at     the end of the visit as is routinely done and scores subsequently compared.   "
51493|NCT02611609|"     A study to examine the safety (and potential efficacy) of the adult stem cell investigational     product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The     primary hypothesis is that MultiStem will be safe in ARDS patients.   "
51494|NCT02611596|"     The purpose of this investigation is to compare subjects at high risk for silent myocardial     ischemia in the placebo group to subjects at high risk for silent myocardial ischemia in the     ranolazine group to determine if ranolazine can be used as a treatment to decrease silent     myocardial ischemia (SMI). Subjects at high risk for silent myocardial ischemia are defined     in this protocol as diabetics with stable ischemic heart disease. This study will look at the     impact ranolazine treatment has on biomarkers that have been shown to be highly associated     with increased risk of morbidity and mortality in relation to SMI. If the hypothesis is     correct, further studies can be conducted to determine if treatment with ranolazine has     impact on long-term outcomes such as hospitalizations, myocardial infarction, congestive     heart failure or sudden cardiac death.   "
51495|NCT02611583|"     Patients presenting to the ED with a chief complaint of acute low back pain and whom the     providing physician feels symptomatic treatment is appropriate in the ED will be screened for     inclusion in the study. The purpose of the study is to compare Transcutaneous Electrical     Nerve Stimulation (TENS) as an adjunct to ibuprofen in the treatment of acute low back pain     in the emergency department. Therefore, the aim of this prospective, randomized, double blind     study is to evaluate the efficacy of ED administered TENS in acute low back pain patients     during their ED visit.   "
51496|NCT02611570|"     This study utilizes the low dose computed tomography(LDCT) to detect the occurrence of early     lung cancer among non-smokers in Taiwan. Subjects who have family history of lung cancer or     have high risk exposures to lung cancer will be recruited to participate LDCT screening and     followed up for their possible occurrence of lung cancer.   "
51497|NCT02611557|"     This study will apply novel, noninvasive structural and functional magnetic resonance imaging     (MRI) methods to patients with mild and moderate breast cancer-related lymphedema (BCRL) for     the first time to test fundamental hypotheses about relationships between lymphatic     compromise and imaging biomarkers that may portend disease progression and individualized     therapy response.   "
51498|NCT02611544|"     Fear of cancer recurrence (FCR) is one of the most prevalent, persistent, and disruptive     sources of distress for adult cancer survivors. Prevalence rates for FCR have been estimated     at up to 89%, with approximately half of cancer survivors reporting clinically significant     levels of FCR. Despite the recognized prevalence, persistence, and suffering associated with     FCR, effective and accessible treatments for FCR are lacking and urgently needed. Our     long-term goal is to develop, evaluate, and implement effective behavioral interventions for     cancer survivors suffering with FCR.   "
51499|NCT02611531|"     The purpose of this study is to evaluate the effectiveness of two different ways to teach     subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge     home from the hospital to determine durability of the education.   "
51500|NCT02611518|"     The purpose of this study is to look at how taking JNJ-54861911 every day will effect the     amount of rosuvastatin or metformin in your blood after taking only a single dose of either     one.   "
51501|NCT02611505|"     The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of     intranasally administered esketamine in both participants with varying stages of hepatic     impairment and healthy participants.   "
51502|NCT02611492|"     The Primary objective is to assess the non-inferiority of the experimental arm (arm B)     compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the     4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+)     acute lymphoblastic leukemia (ALL)   "
51503|NCT02611479|"     To identify patient characteristics associated with non-response after spine fusion surgery     for the treatment of degenerative disc disease (DDD).   "
52207|NCT02602197|"     The investigators conducted a prospective, randomized, double blind study to compare the     effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first     24 hours postoperative period in adult patient undergoing septoplasty.   "
51504|NCT02611466|"     The purpose of the study is to evaluate the analgesic efficacy of ASP7962 relative to     placebo.      This study will also evaluate the efficacy of ASP7962 relative to placebo on pain on walking,     function and stiffness; the time course of efficacy of ASP7962 relative to placebo; the     improvement in overall patient status of ASP7962 relative to placebo as well as the safety     and tolerability of ASP7962 relative to placebo.   "
51505|NCT02611453|"     Carbon dioxide (CO2) gas is widely used for luminal insufflation during endoscopic retrograde     cholangiopancreatography (ERCP) of the biliary tract. While frequently observed during     routine ERCP, there are few data on the topic of air or CO2 cholangiography. Our primary     aim is to compare radiographic cholangiograms in patients with biliary tract disease (from     stones or strictures) during ERCP obtained by using carbon dioxide as the contrast medium vs.     conventional iodinated contrast.   "
70645|NCT02361073|"     The event-related potentials may be different in patients with Takotsubo cardiomyopathy than     in patients without Takotsubo.   "
51506|NCT02611440|"     Medication adherence is a major factor to prevent vascular recurrence after a first ischemic     stroke. Nevertheless, it is suboptimal and the implementation of specific interventions are     needed to improve it.      A patient - centered and pluriprofessional structured intervention, targeting the medication,     introduced at hospital discharge and continued at home (by regular telephone contact) could     improve medication adherence one year after stroke.      This intervention would consist of semi structured interviews patient-pharmacist at different     times during one year after stroke. The information about the therapeutic management of the     patient will be shared between healthcare professionals : general practitioners (GP) and     community pharmacists (CP), hospital clinical pharmacist (HCP) and physician (HPhys).      It will allow for decrease of the recurrent stroke and others cardiovascular complications     based on a better adherence to preventive medication. Furthermore the decrease of the     iatrogenic events and the improvement of the quality of life of patients may be also     associated.   "
51507|NCT02611427|"     After recuperating from low back surgery patients often perpetuate a sedentary lifestyle     because they are concerned about injury and recurrent pain. The objective of this study is to     test the feasibility of a program to increase lifestyle walking starting several months after     low back surgery.   "
51508|NCT02611414|"     Functional dyspepsia is a very common disorder of great challenge to clinical management. A     therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct     current stimulation (tDCS) is a novel therapy that pursues these properties, besides its     safety and easy adherence. There is a great need of new treatments for functional dyspepsia.     There is no current study evaluating tDCS for this disease.   "
51509|NCT02611401|"     Multiple Sclerosis has a great impact on psychological functioning of patients and can be     associated with various psychological disorders and symptoms. The most prevalent one is     depression, which ranges from 15% to 47%. Mindfulness Based Intervention (MBI) is a     relatively brief and cost-effective program that has been studied in patients with several     diseases.      Aims. To evaluate the efficacy of a group-based MBI on depressive symptoms, QoL and on     correlated symptoms of MS patients and their caregivers.      Methods. The study design is a randomized controlled clinical trial. The subjects of the     study are 88 patients with MS and depressive symptoms that will be pre-screened from among a     catchment group of about 500 patients using the Beck Depression Inventory-II (BDI). The 88     patients will subsequently be randomized into two groups (44 in the experimental group and 44     in the active control group). The psychological assessment, independent and blind to     treatment, will be performed with the same timing and tools: at baseline (T0), after     treatment (T1), and 6 months after the end of the group intervention (T2). The assessment     will encompass the administration of the clinical interview and other self-report     questionnaires.      The experimental group will undergo a 8 weekly sessions of 3 hours each (plus an all day     session) with group based MBI. The MBI is an Mindfulness Based Stress Reduction protocol     integrated with body centered techniques from Sensorimotor Psychotherapy, in order to better     tailor it on the needs of people with MS suffering from depressive symptoms. The active     control group is designed to control for the non-specific elements of the MBI treatment and     will follow the same structure as the MBI. It will be based on a psycho-educational framework     and will include relaxation techniques.      Primary outcome measures in patients will be: 1) the proportion of participants at T1 and T2     that does not have a BDI-II score greater than 13; 2) the proportion of patients no longer     meeting the diagnostic criteria for mood disorders as assesses by the SCID; 3) the     improvement of FAMS scores for the six primary aspects of QoL.   "
51510|NCT02611388|"     The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS     pretreatment.   "
51511|NCT02611375|"     Non-invasive brain stimulation has gained increasing popularity and research support over the     past several years. Recent research indicates that it might have benefits for improving hand     function in people with spinal cord injury. The purpose of this study is to evaluate the     effects of a type of non-invasive brain stimulation, known as tDCS, on hand function.   "
51512|NCT02611362|"     This study will develop and test a novel, smartphone based gaming intervention to improve     adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to     decrease HIV risk behaviors among men who have sex with men (MSM). In the intervention,     participants will engage with an immersive app/game on their iPhone that is connected to     smart, electronic pill organizer/dispenser. Data on adherence from the pill dispenser will be     integrated into the app/game wirelessly and will translate into enhancements during game     play. While gaming, participants will gain information about their health, improve motivation     for PrEP and medical appointment adherence, and practice healthy behaviors. If the     intervention is found to be effective, it can be tested in a larger study and then     disseminated to other people taking PrEP.   "
51513|NCT02611336|"     Pathophysiology of acromegaly cardiomyopathy is yet unclear and a specific treatment have not     been indicated. It was already demonstrated the positive impact of phosphodiesterase type 5A     (PDE5A) inhibition in several models of cardiomyopathy and in a model of endocrine     cardiomyopathy due to type 2 diabetes mellitus. In this patients with diabetic cardiomyopathy     it was demonstrated an improvement in cardiac kinetic, geometry and performance parameters     and reduction of the ambulatory measurement of waist circumference.      This represents the first study that evaluate heart remodeling and performance changes and     metabolic/immunological/molecular parameters after 5-months of Tadalafil 20 mg in Acromegaly     cardiomyopathy.      The proposed research will test whether phosphodiesterase 5A inhibition could become a new     target for antiremodeling drugs and to discover molecular pathways affected by this class of     drugs and a network of circulating markers (miRNA) for the early diagnosis of acromegaly     cardiomyopathy.      We hypothesize that:        -  the signal molecules cGMP and cAMP could underlie the hypertrophic/profibrotic triggers          related to this model of endocrine cardiomyopathy and that chronic inhibition of PDE5,          activating cGMP signaling pathways, could improve cardiac remodeling due to acromegaly        -  PDE5 inhibition could have a role in lipolytic regulation;        -  neuroendocrine (e.g. natriuretic peptides) and metabolic markers and chemokines (e.g.          MCP-1, TGF-ß) might relate with left ventricular (LV) remodeling in Acromegaly;        -  there are neuroendocrine (e.g. natriuretic peptides), metabolic markers and chemokines          (e.g. MCP-1, TGF-ß) related to cardiac disease in Acromegaly;        -  miRNA expression [miR-208a, 499, 1, 133, 126, 29, 233, 222, 4454] might relate with LV          remodeling in Acromegaly.   "
51563|NCT02610673|"     This is an observational, prospective, non-randomized collection of defined clinical data     under normal conditions of use for the WiCS-LV System, an implantable cardiac pacing system     capable of delivering pacing energy to the left ventricle of the heart without using a pacing     lead.      Patients will be enrolled and followed according to standard of care for 5 years.   "
51514|NCT02611323|"     This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment     with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or     refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with     DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or     stable disease (SD) at the end of induction therapy will receive post-induction treatment     with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end     of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.   "
51540|NCT02610972|"     A case-control study will evaluate the clinical utility of the Congo Red test GV-005 in     following women with a clinical diagnosis of preeclampsia and clinically healthy women in the     postpartum period in Mexico City.   "
51517|NCT02611284|"     The aim of this study is to assess the efficacy and feasibility of a new less invasive     surfactant administration (LISA) technique with a specific designed cannula for surfactant     administration using Beractant replacement in preterm infants <32 weeks of gestation and     compare short and long term outcomes with the intubation, administration of surfactant and     extubation method (INSURE).      This was a single-center, prospective, open-label, non-randomized, controlled study with an     experimental cohort of 30 patients treated with LISA and a retrospective control group     comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was     administered as exogenous surfactant in both groups if patients on nasal continuous positive     airway pressure (nCPAP) during the first three days of life were needed of more than 30% of     fraction of inspired oxygen inspired oxygen fraction (FiO2).   "
51518|NCT02611271|"     Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the     levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The     adsorber is frequently used in series with continuous renal replacement therapy. Up to date,     no data on the removal of antibiotic drugs during combined renal replacement therapy and     cytokine adsorptive therapy is available. Therefore, we want to investigate      - whether and to what extent antibiotic drugs (piperacillin/tazobactam and     imipenem/cilastatin) are removed during combined continuous renal replacement therapy and     cytosorb adsorption in patients with severe sepsis and septic shock   "
51519|NCT02611258|"     Pathophysiology of Cushing's Syndrome (CS) cardiomyopathy is yet unclear and a specific     treatment have not been indicated. It was already demonstrated the positive impact of     phosphodiesterase type 5A (PDE5A) inhibition in several models of cardiomyopathy and in a     model of endocrine cardiomyopathy due to type 2 diabetes mellitus. In this patients with     diabetic cardiomyopathy it was demonstrated an improvement in cardiac kinetic, geometry and     performance parameters and reduction of the ambulatory measurement of waist circumference.      This represents the first study that evaluate heart remodeling and performance changes and     metabolic/immunological/molecular parameters after 5-months of Tadalafil 20 mg in Cushing's     Syndrome cardiomyopathy. The proposed research will test whether phosphodiesterase 5A     inhibition could become a new target for anti-remodeling drugs and to discover molecular     pathways affected by this class of drugs and a network of circulating markers (miRNA) for the     early diagnosis of Cushing's Syndrome cardiomyopathy.      The investigators hypothesize that:        -  the signal molecules cGMP and cAMP could underlie the hypertrophic/profibrotic triggers          related to this model of endocrine cardiomyopathy and that chronic inhibition of PDE5,          activating cGMP signaling pathways, could improve cardiac remodeling due to CS;        -  PDE5 inhibition could have a role in lipolytic regulation;        -  neuroendocrine (e.g. natriuretic peptides) and metabolic markers and chemokines (e.g.          MCP-1, TGF-ß) might relate with left ventricular remodeling in CS;        -  there are neuroendocrine (e.g. natriuretic peptides), metabolic markers and chemokines          (e.g. MCP-1, TGF-ß) related to cardiac disease in CS;        -  miRNA expression [miR-208a, 499, 1, 133, 126, 29, 233, 222, 4454] might relate with left          ventricular remodeling in CS;   "
51520|NCT02611245|"     This study aims to first apply near-infrared fluorescence imaging technology in thoracic     surgery with indocyanine green in China. To evaluate the feasibility usage of the     investigators' fluorescence imaging systems and the safety applications in intraoperative     sentinel lymph node mapping of lung and esophageal cancer, lung nodule imaging, lung segment     resection boundary determination, esophagus - tubular anastomosis, thoracic duct imaging and     chylothorax repairing thoracic surgery. Aim to achieve precise boundaries definition during     thoracic surgery and realize accurate, minimally invasive thoracic surgery with fluorescence     imaging technology.   "
51521|NCT02611232|"     The main objectives of the trial are to study whether daily treatment with liraglutide     improves insulin secretion and glucose metabolism, and whether liraglutide treatment is     tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.   "
51522|NCT02611219|"     The purpose of this feasibility study is to test the potential for successful implementation     of an intervention designed to study the effect of six hours out of bed time on the overall     level of deconditioning in pediatric stem cell transplant (SCT) patients. Previous research     has demonstrated that deconditioning occurs rapidly over the course of the hospitalization     post-transplant and can negatively impact quality of life. By encouraging patients to be out     of bed for six hours each day, it is anticipated that patients will experience less     deconditioning than those patients who previously had no established minimum time out of the     bed.   "
51523|NCT02611206|"     This study will be an open-label 6-week (30 session) trial of active repetitive transcranial     magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation     intensities using a 3+3 study design for safety and tolerability amongst adolescents. This     means that we will only enroll 3 participants at a time and give them rTMS at the stimulation     intensity energy of 80% of motor threshold (MT). If all three participants complete the 6     weeks of treatment with no major safety events (i.e. seizure), we will increase the energy     for the next 3 participants by 5%. If 1 of the 3 participants has a major safety event, we     will enroll 3 more patients at the SAME energy. We will proceed in this manner, increasing by     5% after 3 subjects safely complete treatment at that energy, to a maximum energy of 120% of     motor threshold. If 2 participants in each intensity level cohort experience a major safety     event, we will discontinue running subjects at that energy level. If this happens at our     initial energy level of 80% of MT, we will stop the study. If we reach 2 events in any of the     higher energy cohorts, we will return to the previous energy level and complete the remainder     of the subjects at that energy level.   "
51524|NCT02611193|"     Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and     then be utilized as a cheap conservative management of CTS. Study design: Two-groups     randomized single-blind interventional study.   "
51525|NCT02611180|"     Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign     compounds (antigens) in the body, which they internalize and process. When DCs uptake foreign     antigens, they migrate to secondary lymphoid organs, where the processed antigens are     presented to T cells.      Various DC subsets with unique cell lineages, surface protein markers, and tissue     localization determinants have been identified. For example, Langerhans cells (LCs) and     interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the     skin. Though both are expressed in the skin, they differ with respect to their origin and     surface protein content and can activate distinct types of immune responses. They may also     have different specificities for the capture of antigens and presentation to circulating T     cells.      To date, it is unknown what role, if any, the different DC populations that reside or     repopulate in the skin play in the development and progression of skin graft-versus-host     disease (GVHD) following bone marrow transplant.   "
51526|NCT02611167|"     The purpose of this study is to assess the safety, feasibility, and efficacy of intravenous     allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic Parkinson's     disease (iPD).   "
51527|NCT02611154|"     Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic     profile during anti-doping testing, which is different than the profile seen when     testosterone is administered into muscle, on skin or under the tongue.      Objective: The investigators aim to characterize the unique steroid doping profile following     administration of intranasal testosterone to healthy, active volunteer subjects.   "
51528|NCT02611141|"     Retromolar Intubation is a successful option for intubation in patients with an existing     retromolar gap in the case that the conventional method fails.      Therefore the investigators want to test if the retromolar gap is essential for performing     the retromolar intubation technique.   "
51529|NCT02611128|"     Polycystic ovary syndrome (PCOS) is a common disorder marked by hyperandrogenism,     oligo-/anovulation, and subfertility. The precise causes of PCOS are unclear, but the     pathophysiology involves complex genetic and environmental influences. Importantly, not all     girls with obesity have HA, and free testosterone (T) concentrations are highly variable in     this group. Luteinizing hormone (LH) and insulin concentrations are significant but only     partial predictors of free T in girls with obesity; significant unexplained variability in     free T suggests that additional factors contribute to HA in this population. Abnormalities of     ovarian and adrenal steroidogenesis are likely contributors in this regard, but such     abnormalities are difficult to quantify. Recent Genome Wide Association Studies have     identified DENND1A as a PCOS susceptibility gene candidate. Preliminary in vitro data     strongly implicate a DENND1A splice variant called DENND1A Variant 2 (DENND1A.V2) as a     contributor to excessive theca cell androgen production in PCOS. The investigators' primary     goal with the proposed pilot study is to determine the relationship between urinary exosomal     DENND1A.V2 mRNA and free T concentrations in peripubertal girls. The investigators     hypothesize that urinary exosomal DENND1A.V2 mRNA quantity is a significant and independent     predictor of peripubertal hyperandrogenemia. In this study, the investigators will carefully     phenotype peripubertal girls with and without hyperandrogenemia (primarily in the form of     hormonal, maturational, and anthropometric measurements) in addition to measuring urinary     exosomal DENND1A.V2 mRNA. As a primary analysis, the investigators will examine the     relationship between morning free testosterone and urinary exosomal DENND1A.V2, controlling     for previously-described partial predictors of free testosterone (LH, insulin) in addition to     potential confounders (BMI z-score, bone age). These studies will provide important     information regarding the etiology of HA in peripubertal girls. Ultimately, these data may     lead to a non-invasive test of ovarian/adrenal steroidogenic activity and support the     development of a diagnostic test for PCOS in high-risk peripubertal girls (e.g., those with     obesity).   "
51530|NCT02611115|"     Computed tomographic pulmonary angiography (CTPA) is considered the gold standard for the     diagnosis of pulmonary embolism (PE). PE is a potentially fatal disease in which a thrombus     is lodged into a pulmonary artery blocking blood flow and potentially leading to respiratory     distress, acute right cardiac failure or death. Therefore early and correct diagnosis is     crucial.      The diagnostic and clinical value of CTPA has already been firmly substantiated.     Unfortunately up to 7.3% of PE scans are still deemed to be non-diagnostic, for example due     to insufficient contrast enhancement in the target arteries.      Therefore future research should focus on two important aspects of CT imaging. On the one     hand optimal enhancement for the individual patient, on the other hand preventing additional     risk of CT imaging - namely contrast induced nephropathy (CIN) and radiation risk. Thus the     purpose of our study will be to optimize radiation dose settings (e.g. tube voltage, tube     current) and CM application for the individual patient in CTPA.   "
51531|NCT02611102|"     Determine the effects on lipoprotein profiles of high dose concentrated dietary SFA     (saturated fatty acids) (from MCT (medium-chain triglyceride) oil + butter) in combination     added to coffee. The study will be conducted as a RCT in healthy adults without     cardiometabolic disease or conditions that influence lipoprotein metabolism or other specific     dietary recommendations.   "
51532|NCT02611089|"     The objective of this work is to understand how the disruption of the muscle connective     tissue contributes to the limb soft-tissue defects in radial dysplasia. In parallel, the     researchers will investigate the role of muscle connective tissue in normal limb development.   "
51533|NCT02611076|"     The purpose of this study is to develop and test a series of culturally relevant and     appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and     remaining smoke-free.   "
51534|NCT02611063|"     The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated B     cells will be effective in preventing chronic graft vs host disease (cGVHD) after allogeneic     stem cell transplant. Activated B cells may play a role in development of cGVHD. Inhibiting     the B cell activation using fostamatinib after allogeneic stem cell transplant may prevent     the development of cGVHD.   "
51535|NCT02611050|"     This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery     Disease Option Grid patient decision aid compared to usual care in patient reported     decisional conflict, knowledge, and shared decision making.   "
51536|NCT02611037|"     The purpose of this study is to determine whether the transarterial chemoperfusion treatment     with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant     pleural mesothelioma (MPM).   "
51537|NCT02611024|"     Prospective, open-label, dose-ranging, uncontrolled phase I study with PM01183 in combination     with irinotecan to determine the maximum tolerated dose (MTD) and the recommended dose (RD)     of PM01183 in combination with irinotecan in patients with selected advanced solid tumors.   "
51538|NCT02611011|"     To determine if pregnant women can understand the instructions, carry out the test, and     interpret the test results regarding the need for follow-up or treatment women will be     recruited to complete a test instruction and comprehension assessment and a usability     assessment.   "
86965|NCT02147756|"     The purpose of this study is to compare structural changes in the skin caused by the CO2RE     device versus the Repair.   "
51539|NCT02610985|"     Background:      No randomised trials have been conducted, and only a single retrospective study exists     comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy     was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates     were similar for the two groups. Thus, although one out of nine women is hysterectomized and     although laparoscopy is one of the recommended routes of surgery, evidence whether to choose     2D laparoscopy, 3D laparoscopy is sparse.      Objective:      To compare pain and recurrence to usual activity level. Secondary to compare complications     during the operation, postoperative complications, time to return to work, length of hospital     stay and operative time.      Design:      Investigator-initiated, blinded, randomised controlled trial.      Intervention description:      Operative procedures follow the same principles and the same standard whether the surgeon's     vision is 2D or 3D.      Trial size Roskilde/Herlev Hospital, Denmark:      200 patients in each arm of the study.   "
51628|NCT02609828|"     The purpose of this study is to determine whether tanezumab is effective in the treatment of     cancer pain due to bone metastasis in patients already taking background opioid therapy.   "
51541|NCT02610959|"     The overall aim of the present project is to investigate if intake of cod in pregnancy has     impact on infant development up to 12 month. 142 pregnant women will be allocated into two     groups, one counsuming cod two times the week for four months and one group will continue to     follow their habitual diet. To study this, urine samples, dietary data and blood samples from     the mother and from the infant, as well as data on neurodevelopment and cognitive functioning     will be collected at several time points.   "
51542|NCT02610946|"     The purpose of this study is to empower adolescent renal transplant recipients to fully     understand their medical condition as well as to help them acquire the skills to maintain a     healthy allograft well into adulthood. It is hoped that introducing technological     applications (apps) will assist adolescents in managing medications, clinic appointments, lab     appointments, and in tracking fluid intake, blood pressure, caloric intake, and exercise     frequency. The investigators aim to improve adolescent post-renal transplant outcomes     (increase medication adherence, lower clinic and laboratory no-show rate, lower blood     pressure and BMI, maintain creatinine clearance, decrease proteinuria, decrease incidence of     allograft rejection, decrease hospitalizations) as well as reduce cost.   "
51543|NCT02610933|"     This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation,     who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a     vitamin K antagonist.      The first question is whether replacement of the vitamin K antagonist by rivaroxaban is able     to slow progression of vascular calcification. The second question is whether addition of     vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular     calcification.   "
51544|NCT02610920|"     This study evaluates a new method of testing the lymph nodes in the armpit of patients with     breast cancer for tumor involvement. All participants involved in this study will undergo an     injection of a small amount of iron dissolved in liquid followed by an ultrasound of the     axilla that will make previously invisible lymph nodes visible, allowing them to be sampled     in an outpatient setting.   "
51545|NCT02610907|"     The study investigates the impact real output (subjects own) and simulated output have on the     adhesion of adhesives.   "
51546|NCT02610894|"     The purposes of this study are to determine if use of the Postoperative Care at Home (PoCAH)     tailored self-management program delivered via mobile technology (a mobile app) after     discharge to home will result in: 1) fewer and/or less intense patient symptoms (pain, nausea     and vomiting, fatigue, sore throat, constipation, sleep dysfunction); 2) enhanced patient     satisfaction, perceived self-efficacy, and quality of life; 3) lower healthcare resource use     (patient to healthcare provider calls; unscheduled patient appointments with healthcare     providers; and hospital readmission and emergency department use). A secondary objective is     to assess how easy the mobile app was to use after orthopaedic ambulatory surgery.   "
51547|NCT02610881|"     This study seeks to assess the acceptability, compliance, and preference for iron     supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study     seeks to assess front line health worker perceptions and experiences regarding ease of     implementation of each strategy and delivery strategy preference.   "
51548|NCT02610868|"     Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses     of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.   "
51549|NCT02610855|"     This study will explore the relationship between skeletal muscle and physical activity in     scoliosis patients to provide insight into both the etiology of scoliosis and potential ways     to mitigate the potential harms of treatment.   "
51550|NCT02610842|"     Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to     apply a home based hand care guide in patients with SS and to evaluate its response regarding     hand pain, function, strength and mobility.   "
51551|NCT02610829|"     To evaluate serum levels of gamma tocopherol and it's metabolites after 3 doses, each     separated by 12 hours.   "
51552|NCT02610816|"     The purpose of this interventional study is to test and compare the effectiveness of two     elimination diets—the 1-food elimination diet (1FED, milk only) and the 4-food elimination     diet (4FED, milk, egg, wheat, and soy). The study will also test the effectiveness of     swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was     not effective.   "
51553|NCT02610803|"     The purpose of this study is to estimate the clinical relevance of monitoring patients with     acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the     presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation.     Furthermore to evaluate the prognostic significance of brief runs of premature atrial     complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic     attack and death.   "
51587|NCT02610361|"     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment     effect of a new drug known as BGB-283 in patients with solid tumours.   "
51554|NCT02610790|"     The aim of this study is to quantify pre- and postoperative physical activity of patients     operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be     recorded from 15 days before surgery to the end of hospitalization after surgery in a     prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the     investigators will propose physical activity thresholds (adapted to the age, gender and     patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After Surgery).     Thus, this analysis will allow the investigators to provide patients with physical     rehabilitation programs a la carte during a hospitalization for colorectal surgery.     Connected bracelets will directly involve patients in their care and rehabilitation.   "
51555|NCT02610777|"     The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus     azacitidine versus single-agent azacitidine in participants with higher-risk myelodysplastic     syndromes, chronic myelomonocytic leukemia and low-blast acute myelogenous leukemia.   "
51600|NCT02610192|"     The purpose of this study is to evaluate clinical outcomes following a single injection of     nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis. A     secondary objective of this study is to document the duration of treatment effect following     nSTRIDE injection.   "
51601|NCT02610179|"     The goal of this prospective study is to determine whether there is superiority of 10     Twizzlers to the 50 gram glucola beverage for screening for GDM in a population based study.   "
51556|NCT02610764|"     To investigate the feasibility of evaluation of prevalence and clinical significance and     relevance of circulating tumor cells (CTC) in the blood of patients with resectable     adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The     primary hypothesis is that the number of CTC correlates with tumor burden and response to     treatment. One established and one experimental CTC detection platform will be investigated.     Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant     treatment (time point 1), after neoadjuvant treatment & before operation (time point 2) and     after the operation (time point 3). Results will be compared with healthy controls (one time     point) and correlated with conventional response to treatment evaluation. The persistent     presence of CTC could be a marker for worse response to treatment and predict early     recurrence.   "
51557|NCT02610751|"     -  The investigators hope their study will answer the question of whether or not fetal          testosterone levels are increased in female newborns exposed to nicotine as a result of          maternal smoking during pregnancy. Secondarily they plan to also evaluate maternal          cotinine and testosterone levels and newborn anogenital distance, second digit to fourth          digit (2D:4D) finger length ratio, newborn length and birth weight.        -  The investigators hope by performing this study, they will help to uncover the effect of          tobacco exposure in utero on human female fetal testosterone levels, thus improving the          counseling for tobacco use in pregnancy.   "
51558|NCT02610738|"     The aim of this study is to develop educational packages for children of primary school age     with type 1 diabetes and their parents, and to undertake a small scale feasibility study to     allow evaluation of the curriculum. Paediatric diabetes teams in the United Kingdom currently     deliver education using largely unevaluated teaching materials. By working with the education     profession the investigators aim to develop packages which are based on recognised     educational theory and practice. The investigators hope that use of these will result in     better blood glucose control, reducing the risk of longterm diabetes complications such as     eye and kidney disease.   "
51559|NCT02610725|"     We are seeking to understand the acceptability of an online yoga class for individuals with     mood disorders. MoodNetwork members who are 18 years old or over who have experienced     depression, mania, or hypomania are invited to participate. About 200 MoodNetwork     participants will take part in this study.   "
51560|NCT02610712|"     The purpose of this study is to determine the efficacy of the use of intravenous low-dose     ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in     Glutamate neurotransmission and inflammatory serum markers.   "
51561|NCT02610699|"     Ear infections, or otitis media, are a leading cause of health expenditures and antimicrobial     prescriptions in children. Diagnosis of otitis media requires the ability to view the     tympanic membrane. An instrument called an otoscope with a light source and a magnifying lens     with a plastic tip that conforms to the ear canal is currently the standard of care for     examining the tympanic membrane. Interpretation of otoscopic examinations is     operator-dependent and cannot be seen by anyone other than the person holding the otoscope. A     pocket size attachment that uses the technology and light source of a smartphone to capture     images of the ear canal and tympanic membrane facilitates image documentation of the otic     examination. In previous studies with the device, the investigators have shown that image     quality of photographs of the tympanic membrane taken with the smartphone otoscope are     equivalent to those taken with a camera-fitted conventional otoscope.      In this study, the Community Provider Assessment Study (CPAS), the investigators will perform     a cross-sectional study in which they will randomly assign 3-4 pediatricians to use a     smartphone otoscope as the standard of care device for all ear examinations and 3-4     pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months.     The parents of children examined during the study period with both devices will be invited to     participate in 3 telephone surveys assessing parental satisfaction with the device and     antimicrobial use by their child for the otic complaint. The results of this study have the     potential to improve diagnosis and management of otitis media, thus improving patient care,     reducing costs, and decreasing the opportunity for the development of antimicrobial     resistance.   "
51562|NCT02610686|"     Understanding the extent and regional distribution of CQR vivax malaria and detecting early     signs of resistance is critical to prevent the spread of resistant strains, optimize     treatment guidelines, and reduce the risk of recurrent and severe malaria. In Vietnam, CQR in     P.vivax has been reported sporadically. One study carried out in Binh Thuan province     (central-south Vietnam) at the end of the 1990s demonstrated early P.vivax recurrences (7%)     by Day 16 after a 3-day CQ treatment. However, in a summary report to World Health     Organization (WHO) including data from 11 sentinel sites, from studies conducted between 2006     and 2011 in central and southern Vietnam (total 350 patients), P.vivax is still considered     sensitive to CQ. More recently in a cohort study conducted in Quang Nam province (Central     Vietnam) in which P.vivax patients were treated radically with CQ and primaquine (10-day at     0.5mg/kg/day) following national guidelines, the 28-day failure rate was measured at 3.45%     and CQ blood concentrations measured at day of recurrence (>100ng/ml) confirmed resistance in     three patients. The current national guidelines for the radical cure regimen of P.vivax     infections recommends 3 days of CQ (total 25 mg/kg body weight (bw)) together with 14 days of     primaquine at 0.25 mg/kg bw/ day.      The current WHO protocol recommends a 28-day follow-up to assess the efficacy of CQ for the     treatment of P.vivax infections. However, recurrence of early stage resistant parasites may     occur after Day 28 in the presence of CQ blood levels above the minimum efficacy     concentration (MEC, ≥100ng/ml) and relapses could occur as early as 36 days after standard CQ     treatment. Therefore, in order to confirm CQR it is recommended to extend the follow-up     period, to Day 42 or 63 and measure whole blood CQ level at Day 28 and at the time of     recurrence. Moreover, it has been shown that emerging drug resistance in P.vivax is     associated with delayed parasite clearance after treatment, i.e. some parasites are still     detectable at Day 3. The aim of the present study is to assess the in vivo and ex vivo     susceptibility of P.vivax to CQ in Central Vietnam following the currently recommended     radical cure regimen and using GMP certified CQ.   "
51564|NCT02610660|"     The TOPP-2 registry is an international, non-interventional, prospective registry including     children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further     insights in the disease course and long-term outcome of PH in childhood.      Patients will undergo clinical assessments and receive standard medical care, as determined     by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically     designed to capture the variables that have been proposed as treatment goals in PePH and the     reasons for changes in treatment strategy.      The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World     Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations     for children with PH.      The registry is planned and implemented under the scientific leadership of the Association     for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.   "
51565|NCT02610647|"     The main objective of this study is to compare between groups the level of complexity of the     estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.   "
51566|NCT02610634|"     Parkinson's disease (PD) is associated with problems of gait such as veering, difficulty     turning, an inability to perceive doorways or obstacles, and negotiate uneven terrain. Gait     problems, especially veering, may be exacerbated by visuospatial dysfunction which predispose     to falls, freezing and festination of gait. Visuospatial dysfunction is common in PD and     likely involves peripheral features (e.g. contrast sensitivity) as well as central cognitive     mechanisms (e.g. attention).      Central neuro-degeneration in PD, PD dementia, and dementia with Lewy Bodies may influence     visual function, as impaired visual sampling has been reported in these conditions. Visual     sampling is measured via saccadic (fast eye movement) activity, as saccades are the     mechanisms through which people orientate and explore the environment. The use of objective     devices to reliably measure saccades is important to detect disease related eye movement     changes. Emerging visuomotor research has measured visual sampling in PD using devices such     as electrooculography and infra-red eye tracking, revealing reduced amplitude, speed and     frequency of saccades during various tasks.      Despite recent increases in visuomotor research it remains unclear how PD influences visual     sampling of the environment during gait and the influence of attentional and cognitive     deficits. Recent work demonstrated that people with PD sample their environment less     frequently than controls, despite a slower gait. Saccadic timing was unchanged in response to     environmental cues. Despite this, environmental visual cues (transverse lines on the floor)     have been shown to increase the number of fixations made during gait. However the mechanisms     of this response remain unclear. Cognition is likely of importance, with response potentially     influenced by attentional control.      This observational study aims to examine the influence of cognition on visuomotor control     during gait in PD. This aim will be achieved by observation of visual sampling under several     environmental challenges (straight walk, doorways, turns, visual cue) and a dual task.   "
51567|NCT02610621|"     Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2     invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard     of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by     chemotherapy.      Sentinel node biopsy is also considered standard care when patients have localized breast     cancer. Treatment can often be influenced by whether the results of the biopsy show cancer or     not. However, the biologic factors of the primary tumor have become more important in     determining treatment recommendations in women with clinically node negative breast cancer.   "
51568|NCT02610608|"     This study aims at evaluating clincal practice regarding prevention of arterial and venous     thrombosis following ovarian stimulation.      Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous     thrombosis in women undergoing assisted reproductive technology and 2)to identify the     incidence and risk factors for ovarian hyperstimulation syndrome in these women   "
51569|NCT02610595|"     To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug     resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.   "
51570|NCT02610582|"     The purpose of this study is to proof the safety and efficacy of a single subretinal     injection of rAAV.hCNGA3 in patients with CNGA3-linked achromatopsia.   "
51571|NCT02610569|"     Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The     therapeutic objective, which was originally based on clinical remission, is currently     evolving with the development of biotherapies towards the achievement of endoscopic     remission. Current recommendations for therapeutic management advocate the achievement of     endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy in     the case of EMH. Endoscopic evaluation of the severity of UC is performed during a digestive     endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy for a     partial exploration of the colon) from endoscopic activity scores adapted for UC.      Currently, the score the most commonly used is the MAYO endoscopic score. This is a global     score of increasing intensity from 0 to 3, taking into account the following basic lesions:     vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion     and ulceration. However this score has limits: it does not distinguish deep cavitating     ulcerations with mucous detachment from simple ulcerations which have a better prognosis.      A new endoscopic score specific for UC has been developed and is currently being validated.     It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes     into account the three most reproducible factors - the vascular pattern, the presence of     bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.      To ensure optimal patient care and an adaptation of the therapeutic medical care to the     endoscopic severity of the disease, endoscopic exploration should be performed recurrently.     However, this exploration is an invasive procedure, requires general anaesthesia for     colonoscopy, and can lead to potential complications such as perforation. This explains the     poor acceptance by patients, resulting in a sub-optimal therapeutic support.   "
51572|NCT02610556|"     The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and     cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced     nasopharyngeal carcinoma.   "
51573|NCT02610543|"     This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept     study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary     Sjögren's Syndrome (pSS).      The primary objective of this study is to evaluate the efficacy on overall disease activity     and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.   "
51574|NCT02610530|"     The SIT-DOWN study is a single centered retrospective study in which a total of 90 (ninety)     participants who are overweight (BMI: 25-29.9 kg/m2) and have type 2 diabetes mellitus (T2DM)     will be evaluated for the efficacy of surgical intervention in comparison with medical     treatment. Primary endpoint of the study will be the change in glycemic regulation by the end     of 12 months.   "
51575|NCT02610517|"     Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested     in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the     effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous     drinking in the HIV clinical care setting.   "
51576|NCT02610504|"     Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into     the shoulder for pain in mild to moderate patients   "
53417|NCT02586389|"     This specimen collection is designed to obtain whole blood and tumor tissue from subjects     diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay     using next generation sequencing (NGS).   "
51602|NCT02610166|"     Arthritis in children is a long-term illness and it can make a child's life very difficult.     In children 8-11 years old, the child and their family work together to deal with the     problems that arthritis can cause. Learning to cope with and manage the problems that come     with arthritis can stop it from getting worse. It is important to create programs that teach     children and families how to cope with and manage arthritis. This study will develop and test     an online game that helps children learn how to better manage their arthritis. The goal of     these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if     children who play the game feel less pain, have fewer limitations, and a better quality of     life compared to children who do not play the game.   "
51603|NCT02610153|"     This prospective observational study is to assess the predictive factors of poor control of     international normalized ratio (INR) to determine the treatment strategies received by     patients with a poor control of INR in real-life clinical practice and to explore the     effectiveness and safety of these strategies in patients with non-valvular atrial     fibrillation who start vitamin K antagonist (VKA) treatment   "
51577|NCT02610491|"     Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders     including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition,     overweight has a causal relationship with a chronic low grade systemic inflammatory condition     and increased intestinal permeability. Over the last decade, this multiplex disorder has     progressively become a major worldwide public health problem, because of its association with     increased risk of type 2 diabetes mellitus (DM2), atherosclerotic cardiovascular disease and     all-cause mortality. Scientific evidence for measures to improve cardiometabolic and     intestinal health by non-pharmaceutical means are of urgent need. Administration of the     flavonoid hesperidin to those at risk may have beneficial effects on glucose / insulin     metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory and oxidative     stress biomarkers and gut barrier function.      Objective: To determine the 12-week effect of daily administration of hesperidin on the main     cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin     metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut barrier     function in subjects at risk for MS.      Study design: This is a randomized, double-blind, placebo-controlled study with parallel     design.      Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic syndrome     (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).      Intervention: Participants will be randomly assigned to one of the intervention groups. One     group will receive one daily dose of hesperidin capsules while the other group receives     identical looking placebo capsules for a period of 12 weeks. The capsules will have to be     ingested with a glass of water every morning just before breakfast.      Main study parameters/endpoints: The primary efficacy parameter of this study is the oral     glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function     and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily     administration of hesperidin on lipid profile (blood measurements), blood pressure and heart     rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut     barrier function (blood measurements, fecal samples, urine collection).   "
51578|NCT02610478|"     Background:      Most people infected with the influenza virus have mild symptoms. But some get very sick and     even die. Antibodies in the part of the blood called plasma fight germs like influenza.     Researchers want to see if plasma with high levels of antibodies helps more than plasma with     low levels when transfused into people with influenza. They have plasma from people with high     levels of antibodies from being infected with influenza or getting the influenza vaccine.     They also have plasma with low or no antibodies.      Objective:      To see if plasma with high levels of antibodies works better than plasma with low levels to     treat influenza.      Eligibility:      People ages 2 weeks and older who are hospitalized for symptoms of influenza      Design:      Participants will be screened with medical history and blood and urine tests. They may have a     nasal wash test for influenza. For this, they get a saline rinse in one nostril. A plastic     tube inserted in the nostril collects fluid.      The study lasts 28 days.      Participants will get routine influenza care. This includes standard drugs and possible chest     x-rays.      On Day 1, participants will have:      Physical exam      Blood tests      Throat swab      2 doses of plasma with high antibodies or low antibodies by IV catheter (tube) in a vein.      On Days 3 and 7, participants will return to the clinic, if no longer hospitalized, for     1-hour visits. The visits include:      Medical exam      Blood tests      Throat swab      On Days 2, 14, and 28, participants will be evaluated either at the clinic or by phone. They     will talk about their symptoms.   "
51579|NCT02610465|"     Background:      Computed Tomography (CT) scans make detailed pictures of the body in seconds. CT scans make     pictures by passing x-rays through a person. CT scans are common. In 2011, around 85.3     million of them occurred in the United States. Researchers think CT images can be made better     using new techniques. Higher resolution images can be derived from the original scan.      Objective:      To learn if new ways of obtaining and processing pictures of the body from a regular CT scan     can produce images with higher resolution (pixels) and more information than standard     methods.      Eligibility:      People ages 18 and older who are scheduled to have a CT scan and are not pregnant      Design:      Participants will be screened with a review of their medical records.      Participants will have their scheduled CT scan.      The CT scanner used in this study provides enhanced images of inside the body. Researchers     may use the CT scanner in a research mode to test and improve the pictures.      Images from the CT scan will be reviewed.      Any clinical findings from the CT test will be shared with the participant s doctor.      Participants will continue to receive their medical care from their regular doctor.      The CT images will be entered into an NIH research database. In the future, they may be used     for research purposes.   "
51580|NCT02610452|"     The main objective of this study was to assess changes in the quality of life of patients in     a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS)     before and one hour after the passage of a clown therapist .   "
51584|NCT02610400|"     This is a cluster randomised controlled trial with factorial study design comparing the     impact of reactive community-based malaria interventions: 1) presumptive treatment (or TPE,     targeted parasite elimination) versus reactive case detection (RACD), and 2) reactive IRS     (indoor residual spraying) versus control on the incidence of malaria in Namibia.   "
51585|NCT02610387|"     Spasticity is one of the most common disorders in patients with central nervous system     diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a     noninvasive tool that can be used to modulate cortical excitability of the leg motor area,     and the spinal motor circuits as well.      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined     with Biodex balance training on lower limbs spasticity in chronic stroke patients using     laboratory and clinical assessments.   "
51589|NCT02610335|"     In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive     an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the     kyphosis reeducation did not show a real profit in the time compared with the natural     evolution of the pathology. The study assume that the spinal mobility reeducation will reduce     the incidence of pain recurrences compared with the classic kyphosis reeducation.   "
51604|NCT02610140|"     The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine     versus vinorelbine in progression free survival in patients with stage IV mesothelin     overexpressing malignant pleural mesothelioma (MPM).      210 eligible patients will be randomized to receive either anetumab ravtansine every three     weeks or weekly vinorelbine.      Treatment will continue until centrally confirmed disease progression (PD) or until another     criterion is met for withdrawal from the study. Patients will enter follow up phase to     capture safety and endpoint data as required.      Efficacy will be measured by evaluating progression free survival from randomization.     Radiological tumor assessments will be performed at defined time points until the patient's     disease progresses.      Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival     or fresh biopsy tissue may also be collected for central pathology review and biomarkers.   "
51590|NCT02610322|"     Project title: A randomized controlled trial of whole soy diet in place of red/processed meat     and high fat dairy products on metabolic features in postmenopausal women Objectives:     Metabolic syndrome (MetS) is an escalating public health problem especially in postmenopausal     women. Traditional whole soy foods are rich in unsaturated fats, high quality plant protein     and various bioactive phytochemicals that could benefit on MetS. The aim of the study is to     examine the effect of whole soy replacement diet on the features of MetS among postmenopausal     women.      Hypothesis to be tested: Whole soy diet in place of red or processed meat and high fat dairy     products will significantly improve metabolic features.      Design and subjects: This will be a 12-month randomized, single-blind, controlled trial among     208 postmenopausal women with high risk of MetS or early MetS.      Study instruments: After 4 weeks' run-in, participants will be randomly allocated to either     of two intervention groups, whole soy replacement group or control group, each for 6 months.      Interventions: Subjects in whole soy group will be required to include 4 servings of whole     soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or     processed meat and high fat dairy products. Subjects in the control group will remain an     usual diet.      Main outcome measures: The outcome measures will include the indices of metabolic features as     well as a 10-year risk for ischemic cardiovascular disease.      Data analysis: The changes and %change of the metabolic features at 6- and 12-month will be     compared among the two groups.      Expected results: Whole soy diet substitution of high saturated fat and cholesterol rich     animal products will notably decrease the risk of MetS.   "
51591|NCT02610309|"     The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed     to sufficiently stabilize suicidal adolescents within a single ED visit so that they may     return home safely with their families. This study is a randomized clinical trial of FBCI v.     TAU in an urban Emergency Department.   "
51592|NCT02610296|"     The purpose of this trial is to evaluate the reduction in incidence and severity of delayed     graft function with kidney allografts from donors >45 years after brain death (DBD).   "
51593|NCT02610283|"     This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in     subjects who are at high risk for AKI following cardiac surgery. Half of the participants     will receive QPI-1002 while the other half will receive placebo.   "
51594|NCT02610270|"     A suitable concentration of omega-3 fatty acids in relation to omega 6 is considered     necessary for a good cell function and prevention of various inflammatory processes. Diet and     supplementation are the fundamental procedures to achieve the reference values for several     years. Athletes are individuals under physical stress and higher tissue restoration, while     maintaining adequate diets they show, as the rest of humans, lower than desired levels. In     the present study the investigators aims to determine the modification of those levels by the     administration of two different doses of a given product, keeping the same model of diet and     physical and competition.   "
51595|NCT02610257|"     Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor     impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism     underlying these phenomena is still an open debate. Apart from the motor correlates,     cognitive-attentional impairment and somatosensory deficits (especially in the proprioceptive     system) may underlie these motor blocks. The current study aims to unravel whether the     proprioceptive system is involved by manipulating task-relevant or non-relevant     proprioceptive stimuli.      Hence, the main aims of this study are:      (i) to assess the somatosensory function in people with PD that experience freezing of gait     FOG and (ii) to investigate the effects of manipulating both proprioception and attentional     resources on FOUL severity.      Forty-five people will be assigned to three age-matched groups (N=15 each): healthy elderly,     PD patients that experience FOG (FOG+) and PD patients that do not experience FOG. Cutaneous     sensory function and kinesthetic ability will be assessed by means of standardized     user-friendly methods and precise repositioning measures using the VICON motion analysis.     Additionally, participants will perform a newly developed task that can successfully elicit     FOULs (a handwriting freezing-provoking task) on a custom tablet (Heremans et al 2015). The     task will be performed without and with the use of muscle vibration (a well-known method to     stimulate the proprioceptive system). The investigators will manipulate both the timing of     vibration (relevant - after FOUL onset; or non-relevant: before FOUL onset) and the region of     stimulation (neutral: on a bone-mark where there is little if any proprioceptive stimulation;     and on a non-neutral spot: on the forearm muscles). It is believed that FOG+ will present     with worse somatosensory function than those who do not experience motor blocks (especially     in the proprioceptive system). Additionally, the Investigators expect a reduction in FOUL     severity (e.g. FOUL duration) when vibration is applied in a task-relevant way, independently     of the region stimulated. In contrast, it is also expected that when vibration is applied in     a non-relevant way and it may act as a distractor, FOUL duration will increase. This study     will thus be able to distinguish between the contribution of attentional and proprioceptive     resources to the mechanism of motor blocks in PD.   "
51596|NCT02610244|"     ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified     version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration     = 3 daily 35-min sessions for 10 weeks). The main objectives are to determine whether there     is improvement in working memory and attention, a reduction in concerns related to ADHD and     social emotional behaviour,and transfer effects for reading and math following participation     in our MCT.   "
51597|NCT02610231|"     This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to     evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with     moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination     (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD     medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day     follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for     eligibility for the study. Eligible subjects will be treated with istradefylline at a     starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on     the Investigator's judgment of each subject's response and tolerability. If deemed necessary,     one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with     clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have     their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment     visit if there are tolerability issues. The istradefylline dose should remain fixed between     Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any     unscheduled dose adjustment visits. A subject may discontinue from the study at any time.   "
94978|NCT02042937|"     Can participants enhance gluteus maximus recruitment during a single-leg squat test following     a neuromuscular training program?   "
51599|NCT02610205|"     The aim of this study was to explore participants´ subjective experiences and perspectives on     pain and other factors of importance after an early nursing intervention consisting of     caring touch (tactile massage and healing touch) for participants subjected to a motor     vehicle accident with minor or no physical injuries.   "
51606|NCT02610114|"     It is the aim of this trial to use a new computerized cell selection method, in addition to     the current and world-wide used scoring system of fertilized oocytes implemented by Scott, to     determine whether this leads to an increase in pregnancy rates in women undergoing assisted     reproductive techniques.   "
51607|NCT02610101|"     The goal of any research study is to answer questions. The investigators are doing this     research study to answer questions about a nutritional therapy called the Specific     Carbohydrate Diet (SCD) for children with active Crohn's Disease (CD). The SCDiet is a diet     where all grains such as wheat, barley, corn, rice are restricted. Most dairy products     (except certain yogurt) are also restricted. The diet mainly consists of meat, fruits,     vegetables, nuts, oils and honey, and is offered to individuals with active Crohn's disease     as part of standard of care at Seattle Children's.      For this study, the investigators will have three different dietary groups: 1.) Traditional     SCD diet group 2.) Modified SCD to include oatmeal and rice 3.) SCD with whole foods without     added sugar, specifically, the investigators want to know:        -  Is the SCD well tolerated?        -  Is SCD effective for the treatment for active Crohn's Disease?        -  Will the results from the varied three dietary groups have the same results for each          patient?   "
51608|NCT02610088|"     The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium     glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with     type 2 diabetes   "
51609|NCT02610075|"     This Phase Ib study will identify the Maximum Tolerated Dose (MTD) of AZD1775 monotherapy     when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed     by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2     days rest) in 21-day cycles in patients with locally advanced or metastatic solid tumours.     Alternative treatment schedules may be explored if preliminary data suggest these would be     more appropriate.      The effect of food on single dose PK of AZD1775 will be assessed in 12 patients. In this     sub-study, patients will receive a single oral dose of AZD1775 with 240 mL of water, once in     the fasted state and once following a high-fat meal.   "
51610|NCT02610062|"     The purpose of this study is to evaluate the safety and tolerability of AGS67E in subjects     with acute myeloid leukemia (AML) and determine a safe dose for future development. In     addition, this study will assess the pharmacokinetics (PK), the immunogenicity, and the     anti-leukemic activity of AGS67E.   "
51611|NCT02610049|"     This is a randomized, controlled trial of adjunctive art therapy during cognitive processing     therapy for PTSD.   "
51612|NCT02610036|"     The purpose of this study will be the assessment of microangiopathy determined by the     increase of capillary basement membrane thickness and decrease of capillary lumen area in the     foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients   "
51613|NCT02610023|"     Fruits and vegetables are an important source of many different phytochemicals that may     affect health and accurate dietary assessement tools to quantitate dietary intake are     essential. This study will evaluate the correlation of dietary carotenoid intake estimated     from two common and one novel food frequency questionnaire (FFQ) with estimated carotenoid     intake from 3 day diet records as well as measured blood and skin concentrations of     carotenoids. This study will be conducted in healthy adults. These tools may be effective in     estimating the level of these compounds in an average diet.   "
51614|NCT02610010|"     A prior phase III randomized trial showed considerable survival benefit from the combined     treatment of cisplatin-based concurrent chemotherapy and two-dimensional conventional     radiotherapy (2DCRT) for patients with stage II (the Chinese 1992 staging system)     nasopharyngeal carcinoma. However, since intensity-modulated radiotherapy (IMRT) was known to     be superior to 2DCRT in local control, progression free survival and even overall survival,     it is a pivotal question whether stage II [T1N1M0 and T2N0-1M0, based on the 2010     International Union against Cancer/American Joint Committee on Cancer (UICC/AJCC) staging     system] patients can still obtain significant benefit from the additional concurrent     chemotherapy in the IMRT era.      The investigators' retrospective study (PMID:26528755 ) indicated that low risk     nasopharyngeal carcinoma (T1N1M0, T2N0-1M0 or T3N0M0, the 2010 UICC/AJCC staging system)     patients who underwent IMRT could not benefit from cisplatin-based concurrent chemotherapy.     Therefore, the investigators perform this randomized controlled trial to address this     question, on a prudent assumption that IMRT alone was not inferior to IMRT plus concurrent     chemotherapy in stage II patients.   "
51615|NCT02609997|"     Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have     enabled the transition of cataract surgery from blindness relief to refractive correction. An     ideal IOL is the critical component to achieve the refractive target of cataract surgery.     Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all     been suggested as the critical factors of an ideal IOL and widely investigated. Recently,     stability of IOL position has also been suggested as one of those critical factors due to its     close correlation with postoperative visual function. Data suggests that IOL forward movement     of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues     recently reported that 0.5mm decentration of an aspheric IOL could eliminate its     aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional     surgery that put both surgeons and patients in pain.      As the supporting element of an IOL, the haptics are crucial to keep the IOL in place.     Various haptic designs are being compared in terms of position stability of IOLs. Haptic     designs of single-piece versus 3-piece are often compared because they are currently the most     commonly used types. Single-piece IOLs have soft and broader haptics which are made of the     same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs     have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies     comparing these haptic designs have yielded controversial results regarding their position     stability in the capsular bag, which is the most recommended site for IOL fixation in an     uneventful cataract surgery.   "
51629|NCT02609815|"     The purpose of this study is to investigate gut microbiota change and glucose lowering effect     of initial combination therapy of gemigliptin and metformin compared to glimepiride and     metformin in obese patients with type 2 diabetes.   "
51630|NCT02609802|"     The aim of this clinical trial is to evaluate the difference of analgesic potency of     sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth     index.   "
51616|NCT02609984|"     This is an open-label Phase 2 randomized study that will examine the use of the study agents,     CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing     the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with     atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic     sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein.      CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread     and growth of cancer in patients whose tumors express the NY-ESO-1 protein. LV305 will be     given in a prime-boost approach with G305 to induce a potentially synergistic     immunotherapeutic response in combination with atezolizumab.   "
51617|NCT02609971|"     The purpose of this study is to analyze the immediate effects of two exercises protocols on     the whole body vibration, on the strength of the thigh muscles, joint position sense of the     knee and balance in individuals submitted to anterior cruciate ligament reconstruction.   "
51618|NCT02609958|"     This is a single arm, multicentre, Phase 2 study to assess efficacy and safety of ASLAN001 in     patients with advanced or metastatic cholangiocarcinoma who progressed on at least 1 line of     systemic therapy.      25 evaluable patients will be enrolled in the study. After evaluation of initial response in     the first 10 evaluable patients, Sponsor will make a decision on recruitment of an additional     15 evaluable patients. If no response is observed, the study will stop.      The primary objective is to assess efficacy of varlitinib (also known as ASLAN001) as     measured by ORR (based on RECIST v1.1). The secondary objectives are to (1) evaluate the     efficacy of varlitinib, as measured by DoR, PFS, OS and DCR, (2) assess ORR, DoR, PFS, DCR     and OS by tumor EGFR/HER2 status, (3) assess safety and tolerability of ASLAN001 monotherapy.     Exploratory objectives are to explore possible relationships between response to ASLAN001 and     the protein expression levels and gene mutational status of the proteins and genes via IHC     and PCR/Sequencing.   "
51619|NCT02609945|"     This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is     designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in     adult healthy volunteers.   "
51620|NCT02609932|"     The investigators hypothesize that neutrophils and monocytes developed under the influence of     Interferon- gamma-1b (IFN-γ-1b, Actimmune*) in vivo will display enhanced function across a     broad range of activities related in large part to the transcriptional activation effects of     this cytokine. The investigators will evaluate the effects of IFN-γ in healthy human subjects     in vivo on gene expression, biologic activity markers, and functional activity of myeloid     cells in single dose studies and in steady state studies.   "
51621|NCT02609919|"     Our primary outcome is to assess the safety of Dotarem in children <2 years old up to 24     hours after Dotarem injection. Patients will be monitored for any adverse events that occur     for 2 hours following the completion of the MRI exam. The type of event, time of onset,     duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not     related, probably related, related, definitely related, unclassifiable), and subsequent     outcome (required treatment, favorable outcome, recovery with sequela, or death) will be     documented. Parents will be given instruction sheets on who and when to call should any     adverse event occur after discharge. Parents will be called by the radiology department the     next day to identify any adverse events that occurred during the first 24 hours after     discharge from the hospital.      Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be     compared to the combined pre- and post-contrast images following administration of Dotarem by     radiologists who are blinded to the patients' clinical information to assess for improvement     of image quality and delineation of structures with contrast.   "
51622|NCT02609906|"     Proximal humeral fractures are with an incidence of 4-5% the third most common fractures in     the elderly. Compared to fractures of the upper limb it is the second most common fracture     after distal radial fractures. 65% of all patients with a proximal humeral fracture are older     than 60 years. Being aware of the demographic change there will even be an increase of     incidence of these fractures. Kannus et al. showed an incidence of 298 per 100,000 in the at     least 80 years old patients in 2007. Palvanen et al. predict an increase of incidence of 50%     until 2030.      Approximately 80% of all humeral fractures are minimally or non-displaced and can be treated     conservatively with a good functional result. In 20% of humeral fractures there is an     indication for surgical treatment according to the modified Neer-Criteria. These criteria are     fulfilled if there is an angulation of at least 45 degrees between fracture fragments, a     displacement of the humeral shaft against the humeral head of at least 1 cm or a dislocation     of the tuberculum of at least 5 mm.      Up to now there is evidence for superiority of any surgical treatment in literature. At the     moment the most frequently used surgical technique for treatment of proximal humeral     fractures is the angle stable plate fixation. There are various publications concerning this     topic published by the investigators research group. In their 10-years results a majority of     patients showed excellent and good, but also 16% showed unsatisfactory results after locking     plate fixation. Main risk for poor outcome was revision surgery caused by secondary     displacement (14%) which is also confirmed by results of other studies. In a further study     investigators could show that there is a higher risk for secondary displacement in     2-part-fractures with a gross primary dislocation or a large metaphyseal fracture zone (AO     11-A3), especially in osteoporotic patients. More over these are common fractures and because     of that a problem in surgical treatment.      A secondary varus dislocation of the head fragment and cutting-out are the most common     complications of angle stable locking plates in AO 11-A3 fractures of the elderly. The     primary reason for this mechanism of failure is certain instability of transmetaphyseal     fractures in the region of the surgical neck caused by loss of impaction in a porous     spongiosa. Because of that the forces on the head screws are high while the so called     screw-bone-interface is rather weak after a surgical treatment.      Currently there exist various approaches to avoid a failure of the primary screw     implantation. One possibility to increase the stability of the screw-bone-interface is the     cement augmentation of the screw tips. To date there exist no clinical study that reports the     results of locking plate fixation and the augmentation of cannulated head screws although it     is a widely used method in everyday surgery, especially in the elderly.      A second possibility to prevent secondary displacement after surgical treatment of     2-fragment-fractures is the use of an intramedullary nails. A further development of     intramedullary nails is multiplanar nailing. Screws can be inserted in various different     levels and directions which can lead to a clearly higher stability.      A comparison of these two treatment options augmented locking plate versus multiplanar angle     stable locking nail in 2-part proximal humeral fractures has not been carried out up to now.   "
59951|NCT02500849|"     The purpose of the study is to evaluate the safety and feasibility of administering     SB-728mR-HSPC after conditioning with busulfan.   "
51623|NCT02609893|"     This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who     currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF)     for 8 weeks. The study will enroll 30 participants and will assess the feasibility and     acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed     therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence     support; and assess through in-depth, semi-structured qualitative interviews, the challenges     with time intensity required for mDOT and unobserved dosing interventions, and identify key     factors affecting treatment adherence.   "
51624|NCT02609880|"     Gynecologic cancers cause substantial morbidity and mortality among women. Developing,     implementing, and disseminating interventions that reduce morbidity and mortality secondary     to gynecologic cancers are a public health priority. In spite of this, there is a paucity of     research examining the effects of psychosocial interventions on patient-centered and     physiological outcomes in this population. To the extent that psychological factors may     influence quality of life and tumor biology among women with gynecologic cancers,     psychological interventions may represent an important adjunct to standard clinical care in     this population. As such, this study will examine the effects of a psychosocial intervention     on sleep, pain, mood, cortisol, and cytokines in women with gynecologic cancers.   "
51625|NCT02609867|"     The purpose of this study is to evaluate the safety and short-term effectiveness of     implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked     cerebral aneurysm in the internal carotid artery.   "
51626|NCT02609854|"     ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical     device which, when applied to various areas of the body applies Low Intensity Therapeutic     Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment     of muscle spasm and joint contracture, and increasing local circulation. This study will look     at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with     chronic low back pain, a subset of which will have chronic low back pain due to a herniated     disc, over an 8-week treatment period.   "
51627|NCT02609841|"     This study assesses serum potassium and cardiac rhythm trends in subjects with end stage     renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.     Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks prior     to enrollment.The number of subjects on 3K or higher dialysate will be limited to 60, with     the remainder of the subjects on 1K or 2K dialysate.   "
51631|NCT02609789|"     The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following     single ascending intravenous (IV) dose administration in healthy participants and a single     subcutaneous dose in healthy participants and multiple IV dose administrations in     participants with mild to moderate Systemic Lupus Erythematosus (SLE).   "
51632|NCT02609776|"     The purpose of this study is to evaluate the safety and pharmacokinetics, establish one or     more recommended phase 2 dose (RP2D) regimens, and to assess the preliminary efficacy of     JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).   "
51633|NCT02609763|"     This observational study will test the inter-rater and test-retest reliability of the LESS     scale in a live context.   "
51634|NCT02609750|"     WorkUp is a prospective cluster randomised controlled trial in primary care. The main purpose     is to investigate effects of early structured care based on screening of red flags (signs of     serious medical conditions/disease), yellow flags (psychosocial factors, attitude to pain)     and blue flags (workplace related factors) and including a workplace intervention according     to the method Convergence Dialogue Meetings (CDM) for improving work ability, in comparison     with treatment as usual, in patients with neck and/or back pain.   "
51635|NCT02609737|"     This study has 3 steps and not everyone will have all 3 steps done. The overall goals are to     see if a new experimental drug is safe to image (step 1) and treat neuroendocrine tumors     (step 2 and 3).   "
51636|NCT02609724|"     The main scientific objective of this multicentric double-blinded randomised controlled trial     entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus     placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic     Therapy, for the treatment of BCRL Secondary scientific objectives entail examining the     relationship between different variables of lymphoedema at baseline   "
51637|NCT02609711|"     primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and     Atorvastatin   "
51638|NCT02609698|"     This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery     disease in order for the objective of verifying the non-inferiority of results that among     patients who were administered DAPT for 3 months compared to patients who were administered     DAPT for 6 months, in terms of the efficacy and safety of DAPT.   "
51639|NCT02609685|"     The purpose of this study is to better understand the outcomes of active surveillance     (observation) instead of immediate surgery, which is the current standard of care for     papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s)     with papillary thyroid carcinoma will be eligible for the study.   "
51640|NCT02609672|"     Exercise is effective at reducing pain while improving physical function. However we do not     know if exercise can boost resilience in the workplace, to allow people with osteoarthritis     to work as long as they desire. Previous research shows that exercise holds the most promise     for helping people enjoy their work because it reduces sick time, reduces pain, and improves     productivity. However, little work has examined the effect of exercise for people with     arthritis in the workplace. The purpose of the study is to investigate whether exercise     improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to     no exercise in those with knee and/or hip osteoarthritis.   "
51641|NCT02609659|"     This study seeks to assess the safety and efficacy of treatment with     ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin in non-cirrhotic, genotype 1a     (GT1a) hepatitis C virus infected participants who are treatment-naïve or     treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without     Ribavirin (RBV).   "
51642|NCT02609646|"     The purpose of this study is to investigate the pharmacokinetic properties in critically ill     patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem,     piperacillin/tazobactam, vancomycin). The primary objective is the identification of the     clinical parameters affecting the kinetics of these drugs and the study of the contribution     of extracorporeal depuration techniques to the elimination of these molecules. The secondary     objective is to describe and compare the therapeutic therapies adopted in the Intensive Care     Units participating in the project.      For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For     each patient five blood samples will be collected on average, in order to measure drug plasma     concentrations. Patient clinical conditions will be collected through an electronic clinical     record. Finally, on the basis of those data, pharmacokinetic models will be developed to     describe the evolution in time of drug plasma concentrations.   "
51643|NCT02609633|"     This interventional, 6-month post-marketing study is designed to evaluate the change in     diabetes-related distress among parents/caregivers of school-age children and adolescents     with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy.     Investigational sites will be assigned using cluster randomization, with approximately 10 to     20 children at each site. In order to maintain a true control group for comparison, the     investigational sites will be randomly assigned to the Accu-Chek(R) Connect diabetes     management system (DMS) or usual care/continued use of current DMS devices.   "
51644|NCT02609620|"     This study is designated to test the safety and initial efficacy of the LunGuard's PFT device     for reduction of GER.      Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will     have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be     taken by suction on predetermined intervals and analysed for Pepsin A concentration.      The PFT will be removed upon completion of the study's scheduled routine. Patients in the     control group will have a standard polyurethane nasogastric device inserted according to     standard procedure, which is considered the gold standard.   "
51645|NCT02609607|"     The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10     mg rectal suppository every other day improves bowel-related symptoms in patients with     multiple sclerosis. Patients will be randomized to receive either a placebo suppository or     bisacodyl suppository dosed every other day for 4 weeks.   "
51717|NCT02608671|"     This study will be undertaken to question the superiority of use skin adhesive tape (®     Steri-Strip) closure system in wound healing over the traditional running absorbable     subcuticular suture technique in perineal repair after episiotomy.   "
53432|NCT02586194|"     The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in     patients with impaired hepatic function and subjects with normal hepatic function.   "
51646|NCT02609594|"     Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society.     Millions of Americans are afflicted with painful, open, draining sores on their lower     extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best     of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care     specialists see patients who have suffered for years or faced amputation of the limb as their     only option to alleviate the pain.      Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However,     roughly half of patients suffering from venous ulcers will require advanced therapy. Human     amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers.     In addition, it contains cytokines that may accelerate healing. In clinical practice and     recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as     bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human     Amniotic Membrane in venous leg ulcers.   "
51647|NCT02609581|"     To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites     allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual     therapy in special consideration of the chosen titration schedule in everyday practice.   "
51648|NCT02609568|"     By studying individual biomarkers in body fluids such as saliva, there is a potential for     detecting injury to the brain resulting from an acute traumatic even that may not be     detectable by conventional neuroimaging like CT scans.   "
51649|NCT02609555|"     Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of     Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between     the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.   "
51650|NCT02609542|"     The disorder of oral language development is defined by the delay in language acquisition in     children who possess efficient auditory acuity and normal non verbal intellect.      The diversity of language developement disorders depends either in the expressive level or in     the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms     are regrouped under the name of STOL (Specific Troubles of Oral Language).      In the current project the visual exploitation and learning capability of children presenting     a STOL condition will be compared to patients with a normal development. The investigator's     hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7     years of age will present a better performance at verbal memorisation, compared to patients     with a persistent STOL condition after the age of 6.   "
51651|NCT02609529|"     IBS is the most common diagnosis in new patients in our pediatric gastroenterology clinic,     accounting for 36 % of all new patients. Pediatric IBS patients always have a problem with     defecation, characterized either as diarrhea predominant or constipation predominant. About     one third of pediatric IBS subjects have d-IBS. There are no FDA approved treatments for     children with d-IBS. There is evidence that diarrhea predominant irritable bowel syndrome     d-IBS may be caused by a mild inflammation in the intestinal lining. Oral serum-derived     bovine immunoglobulin protein isolate (SBI) is a medical food, believed to treat mild     inflammation in the small intestine associated with some cases of d-IBS, especially those     arising after acute gastroenteritis. It improved pain and diarrhea in adults with d-IBS. Our     aim is to determine if SBI improves the number of spontaneous bowel movements in children     with d-IBS.   "
51676|NCT02609204|"     The main goal of the study is to compile a normative database for the Neuro Optic Vision     Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)     modules. This normalization intends to be included in a probabilistic analysis protocol to     allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges   "
51652|NCT02609516|"     Life expectancy at age 65 in the most deprived fifth of the English population was about 4     years shorter than of the most affluent fifth in 2010. The inverse gradient between mortality     and social position is well established. But how disease patterns and multimorbidity (having     two or more long term conditions at the same time) impact on differential mortality rates is     inconclusive: is it because disadvantaged groups acquire more or more lethal combinations of,     diseases over their life course; or, simply, become ill at ages younger than more affluent     groups?   "
51653|NCT02609503|"     This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and     following standard of care definitive radiation, for locally advanced squamous cell carcinoma     of the head and neck patients who are not good candidates for Cisplatin.   "
51654|NCT02609490|"     A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese     hypertension patients   "
51655|NCT02609477|"     This study is to evaluate the abuse potential of single-doses of istradefylline compared to     placebo and phentermine in recreational stimulant users. Subjects will participate in an     outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a     6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be     approximately 25 weeks total.      Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1)     for the Qualification Phase. During the Qualification Phase, subjects will receive single     oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover     manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3),     to ensure that they can discriminate and show positive subjective effects of the active     controls. Following evaluation of eligibility, subjects may be discharged (those who fail     Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and     then proceed directly to the Treatment Phase. The washout interval between last drug     administration in the Qualification Phase and first drug administration in the Treatment     Phase will be at least 96 hours (4 days).      Following confirmation of eligibility from the Qualification Phase, subjects will be     randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will     receive single oral doses of each of the 6 treatments in a randomized, double-blind,     crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg,     Phentermine 45 mg, Phentermine 90 mg, Placebo.      Each drug administration will be separated by at least 21 days. Serial pharmacodynamic     evaluations will be conducted up to 24 hours after each study drug administration to confirm     exposure to istradefylline.   "
51656|NCT02609464|"     The purpose of this study is to evaluate the role of new barbed suture for closure of wound     during total hip arthroplasty in reducing the risk for wound healing problems.   "
51658|NCT02609438|"     The purpose of this study is to determine whether varying the frequency and length of     activity breaks during the workday will differentially impact sedentary behavior and health     outcomes. Participants will be randomly assigned to take short, frequent breaks (i.e., 1     minute every half hour) or longer, planned breaks (i.e., two 15-minute walks) from sitting     during the workday. They will be instructed to follow the assigned protocols for an 8-week     intervention and the effects of their participation on sedentary behavior and a variety of     health outcomes will be assessed. The investigators anticipate participants in both     intervention arms will demonstrate significant reductions in daily sitting time, bit do not     have an a priori hypothesis regarding the relative effectiveness of each approach.   "
51659|NCT02609425|"     Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims:     1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring     anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in esophagogastric     anastomosis by measure anastomotic stricture rate.   "
51660|NCT02609412|"     Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in     both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into     active trigger points, therapy seems warranted. Besides other modalities, self-massage using     foam rollers (self-myofascial release) has been applied as a treatment. However, there is no     data on the efficacy of this method concerning LMTRP. Thus, the present study aims to     evaluate the effects of different forms of self-myofascial release on LMTRP pain.      Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1) 90s     static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic     self-myofascial release rolling back and forth on the calf muscles for 90s using a foam     roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate in     a familiarization session with the foam roller one week prior to treatments. As an outcome,     pressure pain threshold is assessed with an algometer. The investigators hypothesize, that     static compression can reduce pressure pain of LMTRP more effective than dynamic     self-myofascial release. The investigators further expect that placebo treatment will be the     least effective method.   "
51661|NCT02609399|"     This pilot study is designed to demonstrate the feasibility of utilizing Emergency     Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating     influenza therapeutics, and to provide pilot data for future clinical trial design and     planning.      Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed     influenza into a randomized, open label study of oral versus IV influenza therapeutic to     include symptom evaluation and outcome assessments.      Secondary Objective 1: To identify influenza positive patients utilizing a previously     established triage-based assessment and rapid testing algorithm for suspected influenza     infection.      Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for     potential enrollment biases.      Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected     from ED patients with suspected influenza illness.   "
51662|NCT02609386|"     The purpose of this study is to determine whether a pre-operative regimen of the study drug,     IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single     dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins,     and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to     stimulate an immune response against the cancer.   "
51663|NCT02609373|"     Shift work with circadian disruption has been linked with increased breast cancer incidence.     The mechanisms for this effect are not yet completely understood.      This study evaluates the impact of a previously developed sleep intervention in shift workers     at risk of breast cancer; and assesses mediating variables that may explain the relationship     between shift work and breast cancer.      A sample of women night shift workers were provided with a sleep intervention. The     intervention is a standard approach used in a sleep clinic and is delivered by telephone by a     trained intervener.      Hypothesis: The intervention will improve sleep in women night shift workers, which will in     turn have a positive impact on biological and behavioural risk factors associated with breast     cancer and quality of life.   "
51664|NCT02609360|"     Crystalloid solutions modify acid-base equilibrium according to their electrolyte     composition. Moreover, it has been suggested that these alterations are generated by the     difference between the solution strong ion difference (SID) and the plasma bicarbonate level.     An increased risk of acute kidney injury and renal replacement therapy has been associated to     the infusion of chloride rich crystalloids. This study aims to compare, in patients with     acute respiratory failure undergoing ECMO support, the effects on acid-base status and renal     function of crystalloids commonly employed for circuit priming to a balanced solution created     with a SID equal to patients' bicarbonate level.   "
51665|NCT02609347|"     The aim of this randomized controlled trial is to assess if manual therapy improves mobility,     gait, and balance more than a control group for patients who have undergone open reduction     internal fixation (ORIF) after an ankle/hindfoot fracture.   "
51666|NCT02609334|"     This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating     two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a     positive asthma test (mannitol challenge) prior to enrolment.   "
51667|NCT02609321|"     Surgical treatment of breast cancer is frequently associated with postoperative pain in the     surgical area. Persistent pain after breast cancer management has considerable negative     effects on the quality of life of survivors. The aim of this trials is to evaluate the     efficacy of thoracic paravertebral block with bupivacine 0.5% in reducing the acute pain     postmastectomy compare with surgical wound infiltration with bupivacaine 0.5%.   "
51682|NCT02609126|"     The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to     determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The     study will also provide some preliminary insights into whether the experimental treatment     reduces pain in the knee.      Osteoarthritis is the most common joint disease, affecting over 20 million people in the US     alone. Currently, pain treatments that are injected directly into the knee often work for     only a short time and may also have side effects within the rest of the body. The     experimental treatment is a steroid that is in the same family of drugs as the most common     current injectable treatments for knee osteoarthritis. For this study, the drug is coated     with a polymer intended to prolong the time it stays inside the knee and lessen potential     side effects.   "
51668|NCT02609308|"     Lateral ankle sprains are one of the most common in sports medicine. Considering the sprains     in general, they represent an 85% of the ankle lesions. The incidence in high performance     athletes range from 16 to 21%. It is estimated that 10,000 to 25,000 peoples suffers a     lateral ankle sprain per hour in the United States. The objective of the treatment is to     normalize the articular function and allow the patient to return to his or her normal     physical activities. Platelet rich plasma is a simple of autologous blood with concentrations     of platelets above baseline values. This is rich in platelet derived growth factor which     stimulates cell replication, angiogenesis, transforming growth factor B1, fibroblast growth     factor, epidermal growth factor, and insulin like growth factor. The risks of its     applications are minimal and are usually involved with allergic reactions to other     medications that are applied in combination with the platelet-rich plasma.      To establish that the use of platelet rich plasma and immobilization with a short leg cast in     acute lateral ankle sprains will enhance an early recovery in comparison with just     immobilization with the cast.   "
51669|NCT02609295|"     This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and     the relationship between these alteration and lipoprotein associated phospholipase A2     (Lp-PLA2) activity.   "
51670|NCT02609282|"     This study aims to investigate whether hourly prompts, delivered by Microsoft Office onto the     PC's of office workers, is effective at reducing unhealthy patterns of sedentary behaviour .   "
51671|NCT02609269|"     To prospectively evaluate the utility of genomic expression data as a tool to better     characterize the tumors of individual patients, and to understand how genomic information     from individual patients undergoing routine clinical testing can be used in population-level     analysis to improve treatment and outcomes.   "
51672|NCT02609256|"     Malignant middle cerebral artery infarction(MMCI) has a high rate of disability and     mortality. At present, there is no effective treatment except for craniotomy decompression,     but the controversy of the craniotomy decompression still exists. The project is a     prospective, randomized, single center, open label, clinical controlled trail. The eligible     patients for enrollment are as follows: (1) malignant cerebral artery infarction within 48h     onset; (2) craniotomy decompression can not be performed due to the contraindications, or     refused by the patient or relatives. The patients are randomly assigned into 2 groups:     (1)Medical therapy group: receiving osmotic therapy with mannitol and glycerol     fructose，anti-platelet treatment, statins, and other symptomatic treatments such as     controlling blood pressure, blood sugar, and infection, tracheal intubation or incision, etc;     (2) Stereotactic infarct tissue aspiration (SITA) group: on the basis of medical treatment,     receiving minimally invasive aspiration of infarct tissue 24-48 hours after stroke attacked.     This study is aimed at comparing the efficacy and safety of of SITA in patients with MMCI.   "
51673|NCT02609243|"     Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is     a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to     prevent progression from prediabetes to diabetes have been widely studied, however, without     striking long-term effects of any kind of intervention (pharmacological, behavioral...). The     investigators therefore investigate certain nutritional approaches concerning nutrient     content and favorable food components, targeting metabolic improvement.   "
51674|NCT02609230|"     This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II     dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple     myeloma.   "
51675|NCT02609217|"     The aim of this study is to gain insight in the experiences and expectations of Belgian     parents concerning primary cesarean section. This will be achieved by structured patient     interviews and questionnaires in 24 women undergoing the procedure and their partners. This     group will be divided into two subgroups of 12 multiparous and 12 nulliparous women and their     partners.   "
51688|NCT02609048|"     A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study, to evaluate the     effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an     inadequate response to ursodeoxycholic acid (UDCA)   "
51677|NCT02609191|"     The main objective of this study is to validate the measurement characteristics of a new bone     densitometer, the Stratos DR:        -  Via cross calibration to the results of body composition (BC) measurement results to          those of a reference device (the Discover A by Hologic) in terms of body fat          percentage, lean mass percentage of total body mass and for different subregions (left          and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right          legs, head, android area, gynecoid area, visceral region).        -  And by the evaluation of the reproducibility of the BC measurement results in terms of          fat mass and lean mass.   "
51678|NCT02609178|"     The purpose of this study is to compare among different designs of the occlusal surface of     artificial crowns, trying to determine a guidance of fabricating artificial crowns with     better mimesis of the original tooth crown in terms of morphology.   "
51679|NCT02609165|"     This study aims at investigating the therapeutic potential of recombinant human Nerve Growth     Factor ( rhNGF ) eye drops treatment in patients with Retinitis Pigmentosa (RP) associated     with cystoid macular edema (CME) in a phase II, randomized, double-masked, controlled     clinical trial.   "
51680|NCT02609152|"     The main objective of this study is to evaluate the effectiveness of the administration of a     short acting beta-blocker in terms of effective increase in stroke volume (at least 15%)     after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile     after 12-24 hours of care.      This research seeks to demonstrate that the proportion of patients with an increase in the     systolic ejection superior or equal to 15% (relative to baseline) at four hours is different     between the two arms of the study: (1) an experimental arm where patients receive an esmolol     infusion according to a predetermined procedure and (2) a control arm where patients receive     a saline infusion according to a predetermined procedure.   "
51681|NCT02609139|"     This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study     to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted     and high fat meal fed conditions in healthy subjects.   "
51683|NCT02609113|"     The purpose of this research study is to investigate if magnet therapy is effective as an     alternative therapy for CTS.   "
51684|NCT02609100|"     Acute gastrointestinal bleeding is a common medical problem. When patients with     gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually     originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first     step in evaluating the patient is an upper endoscopy; which allows direct visualization of     the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small     bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has     been the next test preformed if upper endoscopy does not identify the cause of melena/     gastrointestinal bleeding, however less than 25% of patients who present with melena have     bleeding originating in the colon, and the remainder of patients have bleeding originating in     the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill     camera which is swallowed and takes pictures while it travels thought the small bowel and     colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not     identify the cause of bleeding. The investigators are preforming a randomized study which     seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the     cause of gastrointestinal bleeding in patients who present with melena and have normal     findings on upper endoscopy. To do this the investigators will enroll patients who present     with melena prior to their upper endoscopy and if the cause of bleeding is not identified at     that time patients will be randomized to video capsule endoscopy (with the capsule being     placed into the small bowel during the upper endoscopy) or next day colonoscopy.   "
51685|NCT02609087|"     The aim of this study is comparing the effect on cerebral oxygenation by     sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid     endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane     and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol     decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the     cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in     general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are     acceptable. There is little data about the effect of general anethetics on cerebral     oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral     circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than     propofol in patient have impaired cerebral circulation.   "
51686|NCT02609074|"     Objective: The investigators initiated a pilot clinical study to test safety and preliminary     efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and     rehabilitation protocols.      Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been     considered as the most perspective among all bone substitutes, yet little progress of its     clinical translation has been made. The concept of micro-scaffolds was proposed in this     study to provide a trajectory to its clinical translation.      Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further     applied as an easy-to-operate filler for bone regeneration in a pilot clinical study.     Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a     similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2     microffolds or traditional CPC paste (control group).   "
51687|NCT02609061|"     The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the     treatment of mandibular degree II furcation defects when compared with PRF and open flap     debridement (OFD) alone.   "
51690|NCT02609022|"     Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical     trial is a safety and proof-of-concept study (proof of mechanism of action) intended to     assess the safety, tolerability and immunogenic response following 3 subcutaneous injections     of CV-MG01 as a potential therapeutic vaccine / active immunotherapy in myasthenia gravis     (MG) patients.   "
51691|NCT02609009|"     Adolescent idiopathic scoliosis (AIS) affects 2 - 3% of children and adolescents older than     10 years and is of unknown cause. It was initially thought that back pain (BP) occurrence was     similar to the one encounter in healthy adolescents. Recently though, literature has shown     that BP seems to occur twice as often than in a healthy adolescent's. As such, BP appears as     a condition that might have detrimental effect on the well-being of that population, and, as     the investigators know, is associated with increases in healthcare costs. Of interest, BP in     adolescents would appear to be a predictive factor for adult BP. Is vertebral manipulation     (VM) a viable alternative? Since 2006, four guidelines were in agreement as to the value of     that approach with acute or chronic BP in adults. Unfortunately, no study was found in     adolescents. The purpose of the investigators study is to verify if VM is efficacious at     improving AIS patients' back pain and to find out if it can help these patients to obtain a     better quality of life and improve their spinal flexibility. Recruitment will take place at     the Ste-Justine's hospital where patients will have 2 evaluations, conducted by an     independent orthopaedist (baseline and 4 weeks). Patients will be allocated to either the     experimental (VM) or the usual medical care group. Spinal manipulation treatment will spin     over a 4-week period. The investigators study will be the first trial evaluating the efficacy     of vertebral manipulation in adolescent idiopathic scoliosis patients with back pain.     Finally, no other study was found on available and effective treatment in regard to back pain     management of this population. A well-structured trial is needed to provide clinicians with a     better understanding and best evidence regarding treatment protocols.   "
51703|NCT02608853|"     This study is conducted in the United States of America. The aim of this study is to estimate     incidence rates of all malignant neoplasms, specific subgroups of malignant neoplasms, and     acute pancreatitis among cohorts of antidiabetic drug users standardized to be representative     of LEADER™ trial participants or liraglutide initiators within the Humedica Electronic Health     Record (EHR) database.   "
51704|NCT02608840|"     This study will evaluate the ability of sounds played during slow wave sleep using a phase     locked loop algorithm to enhance slow wave sleep and memory in cognitively healthy older     adults and in those with amnestic mild cognitive impairment.   "
51705|NCT02608827|"     Hypertension is serious health problem in Brazil and affects almost 30%of adult population.     It is known that there are pharmacologic and nonpharmacologic strategies for treating     hypertension. Aerobic exercise and slow breathing are nonpharmacologic methods that reduce     blood pressure in an isolated form, but its combinations has never been studied. The aim of     this study is to evaluate the association of both strategies and also the mechanisms involved     in blood pressure reduction using slow breathing, in stages 1 and 2 hypertensives.   "
51692|NCT02608996|"     Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial     infarction, and heart failure. Its myocardial complications result from increased mechanical     load on the heart. Under physiological conditions of increased myocardial load and resulting     myocardial stretch, atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP)     synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood     pressure homeostasis. However, studies indicate that in subjects with cardiovascular diseases     the biological structure of these hormones may be altered, thus reducing their favorable     protective activities. New studies indicate that early and moderate hypertension is     associated with a derangement of the natriuretic peptide system which is characterized by the     lack of activation of biologically active ANP and BNP, while severe hypertension is     characterized by Cardiac release of altered molecular forms of ANP and BNP that have reduced     biological Properties and/or enhanced degradation.      The broad objective of this proposal is to advance the biology and therapeutics of the NPs     with a special focus on the cardiac peptide BNP in human hypertension. Our proposal is based     upon the biological properties of BNP (i.e. natriuretic, renin-angiotensin-aldosterone     suppressing, vasodilating, anti-fibrotic, anti-hypertrophic and positive lusitropic), its     mechanistic role in human hypertension, and thus its potential as an innovative chronic     protein therapeutic to enhance the treatment of patients with uncontrolled hypertension.     Importantly, BNP is an endocrine hormone normally produced by the human heart, and it has     been approved for the treatment of acute heart failure in USA.   "
51693|NCT02608983|"     Seaweeds are a natural source of nutrients, and dependent on the variety, are rich in dietary     fibre, proteins, essential vitamins and minerals. However this resource is highly     underexploited. Countries such as Japan, China, North and South Korea are large consumers of     edible seaweed while exposure in Western countries is much lower and mainly as industrially     extracted seaweed derivatives, a common additive in many food and healthcare products.     Seaweeds have been associated with a number of human gut promoting health benefits such as     decreasing faecal transit time through the gastrointestinal tract thus preventing     constipation and resulting in a reduced exposure to harmful substances (decreasing colon     cancer risk). These health benefits can be attributed to seaweeds high dietary fibre content.     Interestingly, the food and healthcare industry already utilize seaweed-extracted fibre in     the manufacturing process thus steering the way forward towards the development of novel     functional food products. These seaweed-extracted fibres are high molecular weight     polysaccharides known as hydrocolloids and are non-digestible by humans, hence classified as     dietary fibre.      Traditionally, seaweed derived polysaccharides (hydrocolloids) have been used to provide     thickening and gelling functionality to food stuffs and other industrial applications however     there is emerging evidence to show that lower molecular weight polysaccharides and     oligosaccharides derived from these hydrocolloids can also act as a source of soluble fibre     and may have prebiotic activity. Recent developments in Japan and Korea have lead to the     commercial availability of products containing low molecular weight seaweed derived fibre.     There is also some evidence for the beneficial effects of seaweed derived fibre in other key     health areas such as cardiovascular health, cancer, diabetes and obesity. However, relatively     little is known about the chemical, physio-chemical and fermentation characteristics of     seaweed fibre in the human gut. Some hydrocolloids, notably guar gum (plant source), have     also been employed for their health promoting properties in the areas of glucose tolerance     and cholesterol lowering. However the use of hydrocolloids as functional food ingredients     with health benefits for consumers has been rather limited and has focused more on uses in     products for diabetics.      It is particularly in the area of gut health that small and medium-sized enterprises (SMEs)     involved in hydrocolloid production and processing, can enter the functional food ingredients     market by using innovative processing technology. The total dietary fibre content of seaweed     can be as high as 75% of the total dry weight and a high proportion of this is soluble. The     fibre component essentially comprises the structural polysaccharides i.e. alginate and     fucoidan in brown seaweeds, carrageenan, agar and porphyran in red seaweeds and ulvan in     green seaweeds. As these fibres are primarily soluble, they form viscous gels as they pass     through the gastrointestinal tract. Some of the fibre is fermented in the lower intestine but     in general, soluble and insoluble seaweed fibre tends to pass through the gut without being     digested. In its natural form as part of the seaweed plant, this fibre is typically high in     molecular weight and passes through the gut too rapidly for the gut microflora to utilize it     to any great extent. There is therefore a necessity to develop lower molecular weight forms     that are more soluble and can be added at higher concentrations to food products without     affecting the sensory properties of the product.      The overall aim of the project is to realize an opportunity to produce low molecular weight     polysaccharides (LMWP) from alginate- and agar-bearing seaweeds for applications in food &     health. The two effective agar and alginate LMWPs, identified by in vitro studies, will be     selected for assessment of prebiotic activity in a feeding trial in human volunteers (Ulster     University) as part of an European Union (EU) study. The end points to be assessed will be     stimulation of beneficial bacteria (bifidogenic effects), increased short chain fatty acid     production, beneficial effects on stool formation, and improvements in gut barrier function.     Additionally, benefits of the LMWPs towards blood glucose levels (short term and acute) will     be assessed.   "
51694|NCT02608970|"     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of     BMS-986177 in healthy subjects   "
51695|NCT02608957|"     The objective of the Latella-US study is to demonstrate the safety and efficacy of the     Latella Knee Implant System for the reduction of medial osteoarthritis pain.   "
51696|NCT02608944|"     This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative     assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with     quantitative PET imaging.   "
51697|NCT02608931|"     This is a pilot clinical trial of dronabinol to treat disabling attacks of nausea and     vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or     hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive     disease in which the growth and development of selective nerves is impaired. Patients with FD     suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing,     tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have     intolerable side sides. Our long-term goal is to treat nausea effectively and without side     effects, a therapeutic intervention that would markedly improve the quality of life of     patients with FD.   "
51698|NCT02608918|"     The purpose of the study is to assess the taste properties of HIV inhibitor   "
51699|NCT02608905|"     Sodium-glucose cotransporter 2 (SGLT-2) inhibitors reduce hyperglycemia and improve     peripheral insulin sensitivity by ameliorating glucotoxicity. Insulin resistance in type 2     diabetes (T2DM) is associated with endothelial dysfunction and vascular inflammation. Thus     strategies to improve insulin sensitivity and lower glucotoxicity may improve endothelial     inflammation and vascular inflammation. However, the effects of these agents on vascular     inflammation and endothelial function is not known in patients with type 2 diabetes although     anti-inflammatory properties have been demonstrated in various animal models. In the present     study the investigators will assess if dapagliflozin treatment for 12 weeks decreases     monocyte inflammation and improves endothelial function in patients with type 2 diabetes on     metformin monotherapy.   "
51735|NCT02608437|"     Thi pahse I, dose-escalation trial will determine the MTD, safety and the additional benefit     achieved from adding SGI-110 to ipilimumab therapy in metastatic melanoma patients.     Preclinical evidence generated with SGI-110 in vivo demonstrated that besides having a direct     activity on tumor growth as a single agent, SGI-110 was able to sensitize neoplastic cells     to the anti-tumor activity of CTLA-4 blockade, providing a sound scientific rationale to     develop new immunotherapeutic approaches combining SGI-110 with therapeutic mAb to immune     check-points.   "
51736|NCT02608424|"     In the present study, investigators test the hypothesis that a controlled mechanical pressure     applied on specific sites of both fore-feet (ES) can reduce the inflammatory state and     arterial blood pressure in patients with Parkinson's Disease by increasing the overall     parasympathetic activity and reducing vascular sympathetic modulation.   "
51700|NCT02608892|"     Newborn infants have blood work procedures in their first days of life that cause pain,     distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving     sweet solutions (sucrose or glucose) has been shown to be effective for reducing babies'     pain. However, recent studies of neonatal pain management practices demonstrate infrequent     use of these strategies. There is a need for parent-targeted interventions, to support     parents' involvement in comforting their infants during painful procedures. This pilot RCT     will inform all aspects of a full-scale trial and will evaluate the effectiveness of the     BSweet2Babies video when shown to parents of newborns prior to newborn screening, on     subsequent use of effective pain reduction strategies during the newborn screening blood     test. The participants will be randomized to either the control group (usual care), or to the     intervention group and will be shown the brief BSweet2Babies video on caring for infants     during blood work. The intervention group will be asked to complete a second survey after     viewing the video. To evaluate the use of BF, SSC, or sucrose during newborn screening, the     research assistant will collect data from the electronic medical record.   "
51701|NCT02608879|"     The purpose of this study is to determine the effects of a novel oral care protocol on the     severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for     head and neck cancers. The secondary objectives are to characterize the microbiome associated     with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical     indicators of the intervention. Participants will be enrolled prior to beginning radiation     and/or chemotherapy, and will be randomized to receive either the oral health protocol or     standard of care oral hygiene.   "
51702|NCT02608866|"     The investigators proposed this randomized study to determine the feasibility of delivering     single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate     their toxicity profiles. The investigators' analysis will provide robust data as well as     predictive factors regarding the outcome after SSRS.   "
51706|NCT02608814|"     Pleural infection is a potentially serious infection of the fluid normally found around the     lung and current evidence suggests its incidence is increasing in both adult and paediatric     populations.      Identification of bacterial pathogens causing pleural infection is of paramount importance in     the clinical care of patients are currently, only 40% of patients have a laboratory confirmed     microbiological diagnosis for their pleural infection. An unclear diagnosis can be due to     various reasons such as a small sample volume therefore the aim of the AUDIO study is to     ascertain the capacity of pleural biopsies in improving the microbiological yield of pleural     infection.      Currently, there are no well validated methods for identifying patients presenting with     pleural infection on the basis of initial ultrasound imaging. The AUDIO study will define the     role of baseline thoracic ultrasound in predicting the radiographic, clinical and surgical     outcomes of patients with pleural infection.      The AUDIO study aims to recruit 50 patients from 2 centres with specific pleural expertise     and these patients will be followed up over a 12 month period. Investigators hope that     through the information gathered from ultrasound imaging and pleural biopsies, it will aid     physicians' clinical and therapeutic decision making when treating patients with pleural     infection.   "
51707|NCT02608801|"     The purpose of this study is to investigate patient related factors that contribute to     increased risk of recurrent fractures, to investigate patient adherence to prescribed     anti-osteoporotic drugs and cost-utility analysis.   "
51708|NCT02608788|"     The purpose of intubation for patients under general anesthesia is to maintain their     respiratory function. However, this procedure does cause a postoperative sore throat. Comfort     of patients could be promoted if effective treatment could be found.      The specific aims of this project are:        1. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release          Postoperative Sore Throat.        2. Acular spray for the prevention of postoperative sore throat.        3. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular          to Release Postoperative Sore Throat.   "
51709|NCT02608775|"     The primary objective of this study is to investigate the influence of a standardized noxious     stimulus on the ANI, SPI and hemodynamic parameters during standard propofol and sufentanil     TCI and to see if the ANI and SPI are predictive of a hemodynamic reaction.      In addition the investigators compare the performance of ANI and SPI against one another as     well as investigate if ANI or SPI can be used to find the ideal CeSUF for a given patient.   "
51737|NCT02608411|"     This study aims to assess the role of MET inhibitors as maintenance treatment in adult     patients with extensive stage small cell lung cancer.   "
51762|NCT02608086|"     Psychological First Aid (PFA) is currently the most recommended early intervention for people     affected by recent traumatic events, especially in the aftermath of natural disasters.     Unfortunately, there is no evidence that PFA neither prevents Post-Traumatic Stress Disorder     (PTSD) nor other post-traumatic disorders or symptoms of distress. This project aims to     evaluate the efficacy and safety of Psychological First Aid for the prevention of PTSD and     other post-traumatic disorders or symptoms.   "
53503|NCT02585258|"     Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in     treatment strategies for elderly patients with rheumatoid arthritis:      The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)   "
51710|NCT02608762|"     Background: Neurobehavioral functions and quality of life (QoL) are the important outcome     measurements after radiotherapy in patients with brain tumors and even head/neck cancers.     However, few studies have focused on neurobehavioral functions and QoL after anti-cancer     treatment particularly brain radiotherapy for pediatric/adolescent patients with brain     tumors. This study thus aims to prospectively evaluate those functions in pediatric or     adolescent patients with brain or head/neck tumors in order to provide useful information     about their clinical outcomes.      Methods: A total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or     head/neck cancers, were prospectively recruited. Neurobehavioral functions will be evaluated     using a neuropsychological battery, which includes general cognitive functions, intelligence,     memory, executive functions, information processing and emotional/behavioral expressions. The     QoL will be evaluated by the health-related QoL questionnaire. All participants will be     examined at six phases, which include pre-treatment, 1-month post-treatment, 4-month     post-treatment, 1-year post-treatment, 2-year post-treatment and 3-year post-treatment.      Expected results: Patients'neurobehavioral functions and QoL will show significant     improvement after treatment, and the improvement will not be diminished across each     post-treatment phase.   "
51711|NCT02608749|"     BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on     physical activity in older adults.      METHODS: This was a randomized, parallel-group, prospective study. All participants received     education program including home-based exercise. The IC group consisted of different     modalities of exercise while the LEE group performed machine-based exercise. Body     composition, muscle strength, and physical performance were measured at their baseline and 3     months follow-up.   "
51712|NCT02608736|"     This study evaluates the addition of valproic acid as a chemopreventive drug in head and neck     squamous cell carcinoma (HNSCC) patients that do not have signs of recurrence or residual     disease. The participants will be randomized 1:1 (valproic acid : placebo). The primary     outcome is to document histone acetylation and DNA methyltransferase expression (DNMT) in     saliva collected from participants when comparing valproic acid arm with placebo arm.   "
51713|NCT02608723|"     To check in patients suffering from chronic plantar fasciitis treated with shock wave     therapy, if the outward appearance of the device affects clinical outcomes.   "
51714|NCT02608710|"     The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of     RDEA3170 when given as single or multiple doses   "
51715|NCT02608697|"     The purpose of this placebo-controlled, double-blind study is to assess the effect of several     doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of     high-intensity statin, and to evaluate the safety and tolerability of different doses of     CAT-2054 for 4 weeks.   "
51716|NCT02608684|"     To evaluate the efficacy and safety of anti-PD-1 antibody MK-3475 (pembrolizumab) in     combination with gemcitabine and cisplatin chemotherapy in women with recurrent     platinum-resistant ovarian cancer.   "
56729|NCT02543099|"     The purpose of this study is to assess the clinical efficacy and safety of policosanol on     elderly patients with endothelial dysfunction   "
51718|NCT02608658|"     This protocol represents an open-label pilot study to assess whether oral administration of     SBI in subjects with decompensated cirrhosis with ascites can lead improvements in the     management of the disease. The impact of SBI therapy will be based on changes to markers of     bacterial translocation, gut barrier damage, and inflammation as well as the impact on rates     of SIBO. Study subjects will be given one packet of EnteraGam, each packet containing 5.0 g     SBI, twice daily for 8 weeks.   "
51719|NCT02608645|"     In this study, within the secondary prevention group patients ( diabetes mellitus, coronary     artery disease, peripheral artery disease, who have had events atherosclerotic     cerebrovascular ) , statin use requirement , patients compliance and reaching target     LDL-cholesterol levels (according to European guidelines ) will be evaluated.   "
51720|NCT02608632|"     To increase the number of responders using HFS-guided renal artery denervation (RDN) in     patients with resistant and moderate resistant hypertension   "
51721|NCT02608619|"     The main purpose of this study is to discover how 18F-cholineFCH distributes in the body, and     see if it can distinguish active histiocytes (tumor) from inflammatory (non- tumor) cells.     This tracer has the potential to give the investigators' team more information when trying to     identify the tumor cells that are most important to collect with biopsy. In addition, the     study will measure levels of 18F-cholineFCH in the biopsy tissue.   "
51722|NCT02608606|"     After liver transplantation one of the most important cost, for both patients and their     health insurance system, is immunosuppressive drug therapy. Tacrolimus (FK 506) is considered     the cornerstone of immunosuppressive therapy in solid organ transplantation. Oral     administration is the usual route, however, sublingual (SL) administration has been recently     reported. This method of administration avoids first pass metabolism and allows an     alternative route after transplant surgery, particularly in those patients who should extend     the period of fasting (prolonged intubation, ileus, etc). Interestingly, in some studies, the     dose of tacrolimus SL required to maintain similar plasma concentrations compared with oral     administration, is significantly lower, even up to 50%, which can result in considerable     savings in short and long term. Among these studies, only one was conducted in liver     recipients. This study suggest that SL administration of tacrolimus could allow to obtain     similar concentrations compared with oral administration. The design of this study did not     assess the existence of differences in the dose required and only included six patients.   "
51751|NCT02608229|"     In light of the central role of extracellular signal-regulated kinases (ERK) in pancreatic     cancer, the investigators propose a phase I study to evaluate the ERK inhibitor BVD-523 at     the recommended phase 2 dose in combination with nab-paclitaxel plus gemcitabine in patients     with newly diagnosed metastatic pancreatic cancer. The primary endpoint will be maximum     tolerated dose (MTD) or RP2D and safety. The secondary endpoints include safety, response     rate, biochemical response, progression-free survival (PFS) and overall survival (OS). The     exploratory endpoints include the assessing the impact of BVD-523 on the MEK/ERK pathway and     other major pathway pertain to pancreatic cancer.   "
51752|NCT02608216|"     In this study positron emission tomography (PET/CT) imaging will be used to evaluate     proliferative activity in sites of metastatic disease using the investigational radiotracer     [18F]fluorothymidine (FLT).   "
51723|NCT02608593|"     Approximately 4,000 women undergo a mastectomy for breast cancer each year in the UK and     around 1,500 will have an immediate breast reconstruction. Approximately half of these ladies     will have an implant-based breast reconstruction, of which many have an implant-assisted     breast reconstruction with an Acellular Dermal Matrix.      Strattice™ is an Acellular Dermal Matrix (a pig skin product) made by Acelity. It is used to     cover and disguise the lower part of the breast implant. Acellular Dermal Matrices have only     been widely used for the last eight years and long-term outcomes for women who have had this     form of reconstruction are lacking. Despite this, it is one of the most commonly offered     methods of breast reconstruction in the UK for both ladies with a diagnosis of breast cancer     and in the risk-reduction setting.      The objective of this study is to assess long-term outcomes of Strattice™-based breast     reconstructions in multiple Breast Surgery Centres across the UK. This will be a case-control     study comparing women who have had an immediate implant-based breast reconstruction with     Strattice™ (case) or without (control). This will be achieved by review and analysis of     retrospective data from patients who have undergone immediate breast reconstruction using     implants with or without Strattice™ following either a diagnosis breast cancer or for     risk-reduction. In addition there will be a prospective clinical assessment of the     reconstruction outcomes. Outcomes assessed will include complications, surgical     re-interventions and aesthetic results. These will be related to co-morbid conditions and     other risk factors. Data will also be collected on unplanned interventions associated with a     cost, if available.   "
51724|NCT02608580|"     Sickle cell disease is a genetic disease responsible for an abnormal hemoglobin.The anomaly     has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood     cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility     to infections.      Patients with this disease should be monitored medically continuously from birth. At     adulthood, they will pass from a pediatric medical care system to an adult medical care     system.This transition can be experienced with more or less ease, depending on the     organization within the pediatric and adult hospitals.      This questionnaire aims to assess the quality of the transition between pediatric and adult     services.The investigators want to better estimate hospital work and improve the quality of     care for this type of patients, throughout their entire medical history.   "
51742|NCT02608346|"     BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth     will be included. These patients will be followed up during 30 months (2,5 years) with     mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation     detection and circulating tumor cells detection (CTC) performed at each hospital visit (for     technical reason only patients included at Institut Curie will be proposed to participate to     the CTC substudy).   "
51885|NCT02606435|"     This is a prospective, randomized study with blinded outcome assessment, comparing routine     manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation     myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).   "
53433|NCT02586181|"     The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D     and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis.   "
51725|NCT02608567|"     In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left     ventricular (LV) ejection fraction is well known. Consequently, there is class I indication     for surgery in these patients when LV ejection fraction <50%. However, there is growing     evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal     myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection     is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV     global longitudinal strain, as assessed using speckle tracking imaging with transthoracic     echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and     thus, to improve the risk stratification, the management and the timing of surgery. Several     mono-centric observational small studies recently reported results emphasizing the role of LV     global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and     may provide meaningful data. The investigators hypothesized that LV global longitudinal     strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection     fraction.   "
51726|NCT02608554|"     The present study is a randomized controlled trial, overweight/obese adolescent and young     PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile     and metabolic profile will be determined.   "
51727|NCT02608541|"     An observational study to derive clinically relevant and predictive rib fracture     classification systems, based on retrospective and prospective cohorts, incorporating     assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation   "
51728|NCT02608528|"     Evaluation of FDG PET/CT to image immunotherapy response in adult thoracic cancer.      Compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with     clinical markers of response. PET/CT tumor metabolic response will also be correlated will to     progression-free survival and overall survival.   "
51729|NCT02608515|"     This non-interventional retrospective chart review study aims to evaluate the clinical     outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at     1st relapse and the treatment patterns following progressive disease as part of the routine     clinical practice in Greece.   "
51730|NCT02608502|"     The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of     135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated     lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.   "
51731|NCT02608489|"     The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are     effective and safe in the treatment of patients with dry eye after cataract surgery.   "
51732|NCT02608476|"     The primary objective of this study is to determine the safety and efficacy of CB-03-01     cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial     acne vulgaris.   "
51733|NCT02608463|"     Neuropathic pain is a common pain disorder that is caused by problems in the nervous system.     It affects more women than men and commonly occurs in pregnancy. Physicians have little     information to guide their treatment of neuropathic pain in pregnancy. The overall goal of     this study is to define the course, management, and pregnancy outcomes of neuropathic pain in     pregnancy and the acute postpartum period. It is difficult to manage neuropathic pain in     pregnancy as treatment options must minimize their risk to the unborn child as they have a     direct effect on infant outcomes through their exposure in utero. Thus, other treatments are     needed. Repetitive transcranial magnetic stimulation (rTMS) may be an acceptable alternative     to medications. Transcranial magnetic stimulation uses a magnetic force to change the way     nerves work in the brain. This non-invasive and localized mechanism of action makes it     attractive for use in special populations, such as pregnancy. This will be the first study to     investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study     will enroll 60 pregnant subjects between the ages of 18 and 45. Participation in the study     will last about 15 months with study visits about once a month. All participants will receive     treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a     treatment option.   "
51738|NCT02608398|"     Aim:        -  The overall aims of this study to look at what changes are seen overweight and obese          (very overweight) children, as they get thinner.        -  Specifically the investigators are interested in the chemicals and bacteria that          children pass in their urine and stool because looking at how these change as it tells          us about how their gut and other bodily systems are adapting.      Hypothesis: Metabolic profiling is a useful and accurate tool for observing and monitoring     weight loss in children      Study plan:        -  To observe this weight loss process in children, the investigators will be attending a          commercial weight loss camp called 'MORElife' which takes place every year in Leeds.          This camp is attended by children age 8-17years who are overweight or obese, for between          two and five weeks. It aims to help them lose weight through a structured diet,          exercise, education and support program.        -  The investigators plan to, with the consent of the parent and agreement the child ask if          they would kindly give us a urine sample at the beginning and end of their time on the          camp. For those staying longer than 2 weeks the investigators will also ask for a sample          in the middle if possible.        -  In addition for those children who consent, the investigators will also ask for a small          stool (poo) sample at these same time points although there is no obligation to          participate at all in the study and it will not affect their time on the camp whatever          they decide.        -  Any children who will be attending the MORElife reunion (arranged by the camp at around          10-12 months after) who agree will be asked for a final urine and stool sample to look          at the long-term effects.        -  Each sample is given a code so as to remain anonymous, frozen and transported to the          university laboratory to be analyzed.        -  With permission and consent the investigators will also collect some information about          the children such as, weight and height from the camp coordinators as well as samples of          the diet that they will be fed and example of exercise activities to give a full picture          so that results can be as accurate as possible.   "
51739|NCT02608385|"     Objective:      To determine the recommended SBRT dose to various metastatic locations in patients with     advanced solid tumors, and specifically in the lung in patients with NSCLC, in conjunction     with pembrolizumab treatment.   "
51740|NCT02608372|"     The project is a randomized, 3-way, blinded crossover trial in which 20 healthy, fasted     participants consume meals with 30 g of a linear corn starch and 5 g of one of the seaweeds,     Laminara digitata or Undaria pinnatifida or a pea protein control. The primary aim is to     investigate whether the brown seaweeds affect the postprandial glucose Area Under the Curve     (AUC). Stomach emptying, insulin, C-peptide, appetite-regulating hormones (oxyntomodulin,     glucagon, GLP-1 and PYY), and specific metabolites from the seaweeds in the urine and plasma     as well as subjective satiety are also analyzed.   "
51741|NCT02608359|"     The purpose of this study is to evaluate the safety of abiraterone acetate in Indian     participants with metastatic, castration-resistant prostate cancer who have been prescribed     abiraterone acetate as per locally approved prescribing information.   "
53434|NCT02586168|"     The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as     defined by average glucose disposal rate.   "
51743|NCT02608333|"     Intervention for autism spectrum disorder (ASD) in European French-speaking countries is     often heterogeneous and poorly evaluated. Six French-speaking early intervention units for     children with ASD following the Early Start Denver Model (ESDM) have been created since 2011     with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the     European French-speaking public health system. In those units, Children receive ESDM at     minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at     home) and preschool or nursery.      The first aim of the investigators study is to evaluate the effectiveness of ESDM     intervention 12 hours per week during 2 years on the global development of children with ASD     compared to the interventions commonly available in the community.   "
51744|NCT02608320|"     The purpose of this study is to evaluate the cumulative adhesion percentage for the test     products and the reference products for both small and large patches.   "
51745|NCT02608307|"     In the setting of progressive or recurrent cancer, adolescent and young adult (AYA) patients,     parents, and healthcare providers (HCP) are faced with multiple therapeutic options. Each     treatment option has a unique risk/benefit ratio, resulting in a need to trade one desirable     outcome for another or accept acute toxicities and treatment-related morbidity to increase     the chance of survival. Adding to the complexity of this decision, stake holders characterize     and value the risk/benefit ratios differently.      This study seeks to learn what things are important to an adolescent or young adult with     cancer, parents, and health care providers when making decisions about their treatment     choices.      PRIMARY OBJECTIVE: To quantify the relative importance of various factors believed to be     important to adolescent and young adult patients with cancer, parents, and health care     providers when choosing between treatment options in the hypothetical situation of     progressive or refractory disease.   "
51746|NCT02608294|"     A pilot study was conducted, randomized, triple-blind study with allocation concealment.     Which consisted in the application of KT in the anterior tibial muscle for 24 hours. 14     subjects were randomized into 2 groups: intervention (with voltage) and sham (no pressure).     Patient's gait footage was shot in the opening balance of phases, average balance and initial     contact (first without the application of Kinesio Taping and after 24 hours of application)     to be measured the angles of the ankle joints, knee and hip. Balance was assessed by the     Biodex Balance System platform, configured to analyze the postural stability in level eight.     The mean differences were assessed (MD) between groups and confidence interval (CI) of 95%.   "
51747|NCT02608281|"     Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy     mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this     clinical study is to assess diagnostic accuracy in breast cancer detection in Contrast     Enhanced Dual Energy Mammography compared to CEMRI. Sensitivity and specificity will be     compared for both modalities.   "
51748|NCT02608268|"     The purpose of this first-in-human study of MBG453 is to characterize the safety,     tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453     administered i.v. as a single agent or in combination with PDR001 in adult patients with     advanced solid tumors   "
51749|NCT02608255|"     A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will     be performed and compared to troponin µs for early triage of these patients. This novel     biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact     (T0) and after 30 min simultaneously o troponin Ic.      All patients aged over 18 years with chest pain which may be related to acute coronary     syndrome requiring pre hospital medical contact through the Emergency Medical Service.   "
51750|NCT02608242|"     This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover     design.   "
51753|NCT02608203|"     Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by     radiolabeled somatostatin-analogs.      During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named     somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear     imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this     clinical setting because of the low intrinsic resolution of the technique and its selectivity     for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even     when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and     SRS for the detection of liver metastases from GEP-NETs.      In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive     technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs     with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter     with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many     European centers have already replaced SRS by [68Ga]-PET-SSTa.      Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE     and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively).     Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.      [68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more     lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this     requires further evaluation.      It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the     standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding     [68Ga]-DOTANOC in the work-up of patients.      The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least     20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to     the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS).      110 patients will be included prospectively in 5 different French experienced centers     (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).   "
51755|NCT02608177|"     The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a     sulfonylurea, improves time in normal blood glucose range and reduces blood glucose     variability. Blood glucose is measured using a continuous glucose monitoring device.   "
51756|NCT02608164|"     The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution with     capsules at raising vitamin D status over winter.      This randomised crossover trial will aim to recruit a total of 22 healthy participants for a     total of two 4-week interventions separated by a 10-week washout.   "
51782|NCT02607826|"     Recent pre-clinical data provide strong evidence that short-term starvation before the     administration of cytostatic drugs for the chemotherapy of solid tumors leads to     significantly higher efficacy and lower toxicity levels. However, these findings have so far     not been validated in patients. The aim of this trial is to provide first clinical evidence     regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy     (primary endpoint). Additionally, progression-free survival, adverse events, and overall     survival will be monitored (secondary endpoints). In perspective, short-term starvation     before chemotherapy could represent a simple and secure way to improve both efficacy and     tolerance of chemotherapies at low cost.   "
51757|NCT02608151|"     Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage     pressure with kinesthetic movement significantly increases the weight, bone density and     shorten the duration of stay of premature babies who benefits.      Studies using vegetable oils show an increase in the effect on weight gain by cutaneous     absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin     mechanoreceptors) since it is found in children stimulated an increase in the vagal activity,     acceleration of gastric emptying and an increase in the secretion of insulin and IGF1.      Few studies have evaluated the effects of massage on the medium-term neurological development     in preterm infants and the effect of the essential oils in the effectiveness of touching the     short and medium term massage.      The aim of the investigators study is to evaluate the neurological development in the short     and medium term in premature newborns and biological effects of massage with essential use of     vegetable oil.      Methodology and possible collaborations This is a monocentric, randomized, controlled, in a     neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of     amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment     is administered 10 minutes twice a day for 10 consecutive days watching for signs of     intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age corrected     is used as the first neurological assessment criterion.      The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.)     is used to 6, 12, 24 months corrected age and completed by the parents as a second     neurological endpoint.      A lipid chromatography is performed at the beginning and at the end of the massage time and     at the deliverance from NICU for comparing the profile of children's fatty acids.      Expected results Show that there is an improvement in the neurological development in     children who received massage with vegetable oil ISIO 4. Show that there is a skin absorption     of essential fatty acids that can substitute for a known major deficiency in premature even     in infants fed breast milk.   "
51758|NCT02608138|"     It is well known that insufficient iodine intakes impairs the production of thyroid hormones,     essential for cognitive development and healthy growth.      Although the World Health Organization (WHO) promotes public health measures for an adequate     iodine consumption, it is estimated that one in three school age children remain iodine     deficient worldwide. Whereas there is no mandatory iodisation programs in Portugal, young     infants are among the most vulnerable to iodine deficiency due to their special requirements.      Therefore, the present study aims to evaluate iodine status in school age Portuguese children     (6-12y), compare iodine status in children, cognitive outcomes and thyroid health and monitor     the use of iodised salt in school canteens exploring potential implications in children's     iodine status.   "
51759|NCT02608125|"     This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two     parts, Part A, and Part B. Part A is the dose escalation phase for evaluating the safety and     tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion     phase to further evaluate safety and tolerability, preliminary activity, PK, and PD in     patients with FGFR genetic alterations.   "
51760|NCT02608112|"     This multicenter, prospective, non-interventional study is designed to obtain an accurate     estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under     real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).   "
51761|NCT02608099|"     The purpose of the prospective, randomized cohort in this study is to assess the safety and     efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects     planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation     (NVAF).      Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by     chart review, who are matched to the prospective randomized subjects, will be identified. The     purpose of the retrospective warfarin cohort is to compare the efficacy and safety of     warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted,     combined uninterrupted and interrupted).   "
51763|NCT02608073|"     This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of     oral capecitabine in combination with intravenous (IV) cisplatin in participants with     metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine     treatment, and cisplatin will be administered on the first day of each cycle. The anticipated     time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.   "
51764|NCT02608060|"     This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly     subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's     lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is     4 months, and the target sample size is 30 individuals.   "
51765|NCT02608047|"     The purpose of this study is to elucidate the local epidemic problem and epidemiological     characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and     clinical treatment system of severe cases to reduce the morbidity and mortality of dengue     fever.   "
51766|NCT02608034|"     This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to     investigate the effect of itraconazole and rifampin on the PK of vemurafenib following     multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable     Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other     malignant tumor types that harbor a V600-activating mutation of BRAF where the participant     has no acceptable standard treatment options.   "
51767|NCT02608021|"     This protocol describes a study to validate Neurotrack's visual paired comparison task, aimed     at early detection and monitoring of memory impairment. The investigators will determine     whether the novel task developed by Neurotrack is associated with markers of brain pathology     associated with very early Alzheimer's disease. The elderly subjects studied will be     cognitively normal (CN) or have amnestic mild cognitive impairment (aMCI). For the current     study, the primary brain pathology parameters will be derived from MRI scans. Data from this     study will be correlated with data from a parallel study designed to validate a larger group     of new cognitive tasks by correlating test performance with a broader array of biomarkers of     Alzheimer's disease.   "
51768|NCT02608008|"     The purpose of this study is to collect data regarding the safety and efficacy of     EchoNavigator System Release II during structural heart interventions in the clinical     practice. Data of procedures with and without the use of EchoNavigator System Release II will     be collected, analysed and evaluated.   "
51783|NCT02607813|"     A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway     Alterations.   "
51784|NCT02607800|"     This study will evaluate the safety and efficacy of treatment with     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and SOF/VEL in adults with chronic HCV     infection who have not previously received treatment with direct-acting antiviral therapy.   "
51989|NCT02605083|"     This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and     cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and     antitumor activity of daily oral administration of eFT508.   "
51769|NCT02607995|"     Obesity occurs more frequently in subjects of a lower socioeconomic status and is associated     with a lower income and unemployment. On the other hand, there is limited access of     individuals with low socioeconomic status to conventional obesity treatments and bariatric     surgery.      In STEREOplus the investigators will ascertain unemployed adolescents with obesity and     extreme obesity at five job centers in the Ruhr area. Unemployed obese youths and young     adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years are eligible to participate.     Participants will be asked to complete a series of questionnaires on their general health,     psychosocial situation and wellbeing, and will be offered a thorough medical evaluation.     Individuals who complete the baseline evaluations will be invited to participate in six group     sessions of conventional obesity treatment over a three months period. After six months,     participants will complete further questionnaires to evaluate the effects of the     interventions on quality of life and psychosocial functioning. Weight status (BMI) will also     be measured. Adolescents who attended at least five sessions and are interested in bariatric     surgery will have access to a structured information and preparation program for bariatric     surgery.      The overall objective of STEREOplus is to generate data on the feasibility of the planned     implementation of a treatment targeted to a high risk group with a low socioeconomic     background in order to reduce treatment barriers.   "
51770|NCT02607982|"     This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy     (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced     esophageal cancer patients.   "
51771|NCT02607969|"     30 babies with Deformational Plagiocephaly (DP) due to the congenital muscular torticollis     will be the participants of the study.      The subjects will randomly allocated into the two home program groups; first home program     group was seen once every six weeks (SxW), second home program group was seen once a week     (OW).      Parents will educate about the same home program which consisted of positioning the neck and     head, sleep in alternating head positions and in side-laying to increase head shape symmetry     and place infants, when awake and under supervision, regularly in the prone position a day to     stimulate normal motor development (tummy time), decreasing the time spent in car seat at     supine position. Environmental settings also will be given to challenge the baby look through     from the side no flattening to room, place colorful and sonorous toys or mirror on the     opposite of the flattening side, and stimulate active rotation by communicating with baby     from this side. Handling strategies, stretching and strengthening exercises will be given for     CMT. The parents will be reinforme if necessary. Positioning strategies will spread     throughout the day.Plagiocephaly severity assessment scale (PSS) which has 5 subgroups as     following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear     asymmetry will be used to evaluate severity of DP.   "
51772|NCT02607956|"     This study will evaluate the efficacy of a fixed dose combination (FDC) containing     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC     containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral     treatment-naive adults at Week 48.   "
51773|NCT02607943|"     Hyperglycemia is common during acute ischemic stroke. However, the optimal strategy to     control hyperglycemia during acute ischemic stroke has not been established. The object of     this multicenter randomized controlled study is to determine the efficacy and safety of early     initiation of subcutaneous once-daily insulin glargine, in comparison with regular insulin,     based on a protocolized sliding scale regimen to achieve proper sugar control in acute stroke     patients with hyperglycemia admitted to the intensive care unit.   "
51774|NCT02607930|"     The study will evaluate the efficacy of a fixed dose combination (FDC) containing     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment     naive-adults.   "
51776|NCT02607904|"     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The     open-label extension phase only will be described in this record. All participants will     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or     increase the participant's dose until the optimal dose is found.   "
51777|NCT02607891|"     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The     blinded phase only will be described in this record. Participants will be randomized in a 4:1     ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol     (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using     GWP42003-P.   "
51778|NCT02607878|"     Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might     reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA).     Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly     improve prognostication of post-CA coma, however, EEG and SSEP are not always available and     require specific expertise for their interpretation. Automated video pupillometry is a novel     electronic device that contains an infrared light camera which enables to measure     quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a     recent study of a cohort of comatose CA survivors (n=50 patients) it was found that     quantitative PLR was more accurate than standard PLR (manual pen light) in predicting 3-month     outcome, irrespective of temperature and sedation, and had comparable prognostic accuracy     than electrophysiological exams, including electroencephalography (EEG) and somato-sensory     evoked potentials (SSEP).      Aim of the study: In light of these promising results, the investigators would like to     confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose     post-CA patients.      Design of the study: Prospective, multicenter, observational outcome trial.   "
51779|NCT02607865|"     This trial is conducted globally. The aim of the trial is to investigate efficacy and     long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.   "
51780|NCT02607852|"     The primary objective of the overall study is to determine the feasibility and usefulness of     a feedback system that delivers BOQ results to physicians in real time during outpatient     encounters using iPads.   "
51781|NCT02607839|"     The purpose of study is to examine whether raised blood glucose enhances lipid particle     production independent of effects on gastric emptying and pancreatic/ gastrointestinal     hormone production.   "
51794|NCT02607670|"     This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the     reduction of moderate to severe nasolabial folds.   "
51785|NCT02607787|"     The aim of this study is to assess the feasibility and effectiveness of a home-based walking     and strengthening intervention on physiological, biochemical and psychological outcomes in     colo-rectal cancer survivors.      The intervention consists of a 12-week home-based walking and strengthening programme for     colo-rectal cancer survivors post any anti-cancer treatment. It aims to gradually increase     participants physical activity levels so that they start achieving the recommended levels of     at least 150 minutes moderate intensity aerobic activity per week and strengthening exercise     for all major muscle groups at least twice per week.      As well as usual care, the intervention group will receive weekly telephone calls and a     behaviour change interview at baseline. Participants will be recruited from the Cancer Centre     at the Belfast City Hospital. Assessments will be taken at baseline (0 weeks), post     intervention (12 weeks) and also at a 3-month follow-up (24 weeks). The control group will     receive the same assessments at the same time-points however they will continue to receive     usual care with the intervention information (including pedometer, exercise booklet, diary     and behavioural change interview) being given at the 3-month follow-up appointment.   "
51786|NCT02607774|"     To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using     midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.   "
51787|NCT02607761|"     Recent evidence showed that undergraduate students have inappropriate knowledge about     reproductive health and infertility.      The investigators' aim was to assess the effectiveness of a brief intervention (video) in     increasing the knowledge regarding fertility issues, fertility risk factors and infertility     definition.   "
51788|NCT02607748|"     The purpose of this study is to evaluate whether 18F-NaF (sodium fluoride) Positron Emission     Tomography (PET) scans can be used to identify ruptured and high-risk plaque as compared to     non-invasive coronary Computed Tomography Angiography (CTA) scans and high-definition     intravascular ultrasound (IVUS).      In subsets of patients, 18F-NaF PET scans and CCTA will be repeated to assess scan-rescan     reproducibility.   "
51789|NCT02607735|"     This study will evaluate the safety and efficacy of treatment with     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic HCV infection who     have previously received treatment with direct-acting antiviral therapy.      Subjects randomized to placebo may be eligible for deferred treatment with active     SOF/VEL/VOX.   "
51801|NCT02607579|"     The purpose of this prospective study is to examine the effect of two local anesthetics used     in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain     related interference with activities and hospital length of stay. The two agents are     bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these     drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility,     and pain related interference with activities and hospital length of stay.   "
51790|NCT02607722|"     This is a non-interventional study based on new data collection to gather real-world     information (i.e., data under routine medical practice) on safety and effectiveness of the     Ofev® Capsules treatment.      The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52,     65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be     followed up until discontinuation of Ofev® Capsules treatment.      As this is an observational study, no specific treatment is mandated or withheld from the     patients. The choice of maintenance treatment for IPF must be according to regular medical     practice and at the discretion of the physician (i.e., no randomised assignment of patient to     treatment is performed).      All patients administrated Ofev® Capsules after the launch at the sites contracted with the     sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected.     However the patient registration continues until the approval condition has been removed.      Patients participating in the subsequent follow-up will undergo regular observations. These     observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and     104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment.     Patients will not be followed any longer once they are reported to have discontinued the     Ofev® Capsules treatment.   "
51791|NCT02607709|"     Two out of three tumours in the upper urinary tract are located in the renal pelvis.     Muscle-invasive urothelial carcinoma is probably more common among tumours in the upper     urinary tract compared to tumours in the urinary bladder. Thus, muscle-invasive tumours     represent approximately 45 % of renal pelvic tumours compared to 25 % of tumours within the     urinary bladder. As in the bladder, lymph node metastases are rare in non-muscle invasive     disease. Information regarding indications, extent and possible curative potential is     currently lacking for lymphadenectomy in conjunction with nephroureterectomy for urothelial     carcinoma in the upper urinary tract (UUTUC). There are, however, retrospective series with     survival data for patients with lymph node metastasis that report long term survival after     surgery as monotherapy [4] with similar survival proportions as in bladder cancer with lymph     node metastases after radical cystectomy. A retrospective study from Tokyo was expanded to     the only available prospective study, where 68 patients with UUTUC were submitted to     template-based lymphadenectomy. Another retrospective study by the same Japanese group,     showed that 5-year cancer-specific and recurrence-free survival was significantly higher in     the complete lymphadenectomy group than in the incomplete lymphadenectomy or without     lymphadenectomy groups. Tanaka N et al. reported recurrence rate after nephroureterectomy     without lymphadenectomy at 1 and 3 years were 18.9 and 29.8 %, respectively.   "
51792|NCT02607696|"     This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics     of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size     is 48 participants, male or female, aged above 18 years-old.      Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two     different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and     tolerability of the investigational product.      Participants will be admitted for a period of 36 hours, when investigational product will be     administered, and blood samples, at pre-determined time periods, will be collected for     pharmacokinetics.      Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be     assessed by adverse events occurrence and laboratory exams evaluation.   "
51793|NCT02607683|"     This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the     efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid     steatoblepharon (undereye bags).   "
51795|NCT02607657|"     This is a Phase I, open-label, randomized, parallel trial to evaluate the pharmacokinetics of     Eplerenone tablet at different dosages (25 mg once daily, 50 mg once daily, 100 mg (2 tablets     of 50 mg) once daily and 50 mg twice daily). Sample size is 96 participants (24 per treatment     group), male or female, aged between 18 and 50 years-old.      Primary objective is to evaluate pharmacokinetics of Eplerenone tablet at different dosages,     and secondary objective is to evaluate safety and tolerability of the investigational     product.      Study overall duration is approximately 12 weeks, including enrollment and follow-up visits.     Participants will be admitted for a period of 36 hours, when investigational product will be     administered, and blood samples, at pre-determined time periods, will be collected for     pharmacokinetics.      Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be     assessed by adverse events occurrence and laboratory exams evaluation.   "
51796|NCT02607644|"     Introduction: The laryngeal mask airway (LMA) is used as the primary airway by paramedics in     Singapore Civil Defense Force's Emergency Ambulance Service (SCDF's EAS) in the management of     out-of-hospital cardiac arrest, because endotracheal intubation requires skilled and     experienced personnel, and local paramedics are not trained to this level of skill and     competency. However, self-reported insertion success rates by paramedics in the field are     currently only about 50-87%. Devices like the laryngeal tube have been shown to have higher     placement success rates and fewer complications.      Aim: Investigators aim to evaluate the efficacy and safety of a new device, the Laryngeal     Tube (LT), compared to the LMA. They hypothesize that the LT is superior to the LMA in terms     of placement success rates by paramedics in SCDF's EAS, and is associated with fewer adverse     events.      Methodology: Investigators propose to conduct a prospective, longitudinal multi-centre     randomized trial comparing LMA and LT in patients with cardiac arrest (medical or traumatic)     managed by SCDF EAS. The trial will recruit 875 eligible patients presenting to SCDF     irrespective of destination hospital over a period of 1 year to detect an expected 15%     difference in placement success rate. Currently the LMA is used as standard of care by SCDF's     EAS in patients with cardiac arrest.      Results: Besides the primary outcome, the secondary outcomes of dislodgment rates, time to     placement, number of attempts and adverse events will be analyzed and will be useful in     guiding future SCDF cardiac arrest protocols.   "
51797|NCT02607631|"     This is a Phase II single center, open-label, single arm study in patients with advanced     thymic epithelial tumors after failure of cisplatin-based combination chemotherapy. Patients     will be treated with Pembrolizumab 200 mg every 3 weeks.   "
51798|NCT02607618|"     This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim     compared to vancomycin for the treatment of skin and skin structure infections.   "
51804|NCT02607540|"     A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with     cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But     in China because of its toxic reaction, most of patients stop the halfway.      The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus     5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A     total of 210 patients will be accrued from China within 2 years. The primary endpoint is     overall survival and the secondary endpoints include progression-free survival, response     rate, pathologic complete response rate and adverse events.   "
51805|NCT02607527|"     Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral     regurgitation in subjects determined appropriate for mitral valve surgery.   "
51806|NCT02607514|"     Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy,     and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically     healthy adults with mild to moderate depressive symptoms. The primary aim is to test the     acceptability and feasibility of hyperthermic yoga as a treatment for depression. The     secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive     symptoms. The tertiary aim is to explore physiological and psychological mechanisms of     action.   "
51807|NCT02607501|"     An open label, prospective, multicentre, single-arm, post marketing study evaluating the     safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the     treatment of bifurcation intracranial aneurysms.   "
51808|NCT02607488|"     Increasing rates of obesity over the last few decades have led to growing demand for     bariatric surgery, which may resulted in decreased comorbidities and improved patient     outcomes. Laparoscopic bariatric surgery has several clinical benefits in terms of improved     quality of analgesia, reduced pulmonary complications, enhanced recovery of bowel function,     less immune suppression, and shortened duration of hospital stay than open laparotomies.      Some investigators reported delayed return of bowel function for approximately two days after     laparoscopic bariatric surgery, despite it occurred one day earlier than after open     laparotomy. This potentially can lengthen the duration of hospital stay after bariatric     procedures. With the impeding cost of health care in the developing countries, safely     reducing length of stay is essential.      Other investigators reported early return of bowel movements during the first postoperative     day in 65% of patients undergoing laparoscopic gastric bypass surgery due to reduced morphine     use with implementation of a multimodal analgesia strategy including ketorolac, and     propoxyphene hydrochloride/acetaminophen.      Lidocaine was investigated in several studies for its use in multi-modal management     strategies to reduce postoperative pain and opioid use and enhance recovery. A recent     Cochrane review including 45 trials demonstrated that systemic administration of lidocaine     was associated with reduced pain scores at most of 'early time points' in patients undergoing     laparoscopic abdominal surgery (MD -1.14, 95% CI -1.51 to -0.78; low-quality evidence),     shorter times to first flatus (MD -5.49 hours, 95% CI -7.97 to -3.00; low-quality evidence)     and first bowel movement (MD -6.12 hours, 95% CI -7.36 to -4.89; low-quality evidence), and     less risk of paralytic ileus (risk ratio (RR) 0.38, 95% CI 0.15 to 0.99; low-quality     evidence). However, no evidence of effect was found for lidocaine on shortening the time to     first defecation. This low-quality evidence may be related to the heterogeneity between the     studies in respect to the optimal dose, timing and duration of the administration of     intravenous lidocaine.   "
51809|NCT02607475|"     Robotic telesonography, in which an expert remotely performs sonography in real time, has     recently emerged as an opportunity to perform sonography at remote centres. Using a robotic     system and an assistant with limited training at the remote site, an expert can manipulate an     ultrasound probe and generate images in real-time via an Internet connection. This study aims     to demonstrate the feasibility of robotic telesonography for obstetric and adult and     pediatric abdominal imaging in a centre with established sonography services which will be     used as a comparator to robotic telesonography.   "
51827|NCT02607241|"     This prospective randomized clinical trial aims to compare two different metal-free     strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI     (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS     implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).   "
51810|NCT02607462|"     Study purpose is to evaluate perioperative usefulness of Platelet-rich Plasma (PRP) in total     hip arthroplasty (THA) surgery. The study is designed as a randomized double blinded study     using saline as placebo. The measurement outcomes includes objective variables (MRI,     dynamometer) as well as subjective measurements (Oxford Hip Score, Harris Hip Score).      Patients are assigned to two different groups, according to a randomization list. PRP     (approximately 9ml from which 1ml is delivered to in-house laboratory for the measurement of     platelet count) is obtained from venous blood and applied to m. gluteus medius during the     closure of modified lateral approach (Hardinge).      Study participants are evaluated preoperatively by trained physiotherapist. After surgery,     participants undergo clinical evaluation and imaged (MRI) at 3 and 12 months post-operative.     In the same time points, strength, Harris Hip Score and Oxford Hip Score. At the end of the     study, the nature of the injected substance is revealed to the patients.   "
51811|NCT02607449|"     Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and     development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with     the high burden of tuberculosis, The Government of The Republic of Kazakhstan has founded     initiative on the development of new Anti-TB drug to treat drug-resistant forms of this     infectious disease. JSC Scientific Center for Anti-infectious Drugs has developed original     drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).   "
51812|NCT02607436|"     This is a prospective interventional study to assess the effect of sarpogrelate compared with     aspirin in Korean type 2 diabetic patients with atherosclerosis.   "
51813|NCT02607423|"     This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission     tomography (PET)/computed tomography (CT) works in predicting response to chemotherapy in     patients with stage IIIA non-small cell lung cancer that can be removed by surgery     (resectable). Performing diagnostic procedures, such as fludeoxyglucose F-18 PET/CT, after     one course of chemotherapy may help doctors predict a patient's response to treatment earlier     and help plan the best treatment.   "
51814|NCT02607410|"     To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin ,     with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus     biguanide: effects on beta cell function and on metabolic profile.   "
51815|NCT02607397|"     The cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT)     with photons. Considering potential dosimetric advantages of PT, it is necessary to determine     if PT are more cost-effective than photons per indication regarding quality of life,     survival, and progression free survival. Given the lack of evidence for the benefit of     particle therapy in relevant cases, investigators proposed an in silico trial to investigate     to what extend proton therapy decrease the amount of irradiated normal tissue and,     consequently, the risk of side effects in the surrounding normal tissue as well as the risk     of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower     mean dose of proton therapy on normal tissue compared to photon therapy should result in at     least a 20% lower risk of side effects.   "
51816|NCT02607384|"     The Baltimore Reading and Eye Disease Study (BREDS) is a two year study to determine the     prevalence of vision problems in an early school age population with reading difficulty.     Comprehensive vision and reading tests will be administered to 400 students at participating     schools in the Baltimore City Public School system.      A secondary goal is to examine the impact of vision treatment on reading performance.     Children with refractive error or convergence insufficiency will be provided treatment free     of charge. The investigators will evaluate the impact that the treatment has on vision     function and reading performance.   "
51817|NCT02607371|"     The main research question of this patient survey is to assess AF (Atrial Fibrillation)     patients' preferences associated with different attributes which describe the different     available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral     Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).      VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.   "
51818|NCT02607358|"     Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute     ischemic stroke patients.   "
51819|NCT02607345|"     Objective: to compare blood glucose and insulin responses after consumption of 100ml water,     sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)   "
51820|NCT02607332|"     With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib     (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients     with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib     (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with     imatinib. However, virtually all patients will eventually progress or become intolerable     after the first-line imatinib and the second-line sunitinib.   "
51821|NCT02607319|"     The objective of this study is to determine the effect of Bemiparin, a low molecular weight     heparin, on implantation rate in women with unexplained recurrent implantation failure     undergoing IVF/ICSI treatment.   "
51823|NCT02607293|"     This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the     population at high risk of overstimulation associated with signs and symptoms of PCOS and     examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for     individualized controlled ovarian stimulation (iCOS).   "
51824|NCT02607280|"     Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral     Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal     impairment.   "
51825|NCT02607267|"     The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related     diseases and predictor of mortality than BMI or waist circumference. The aim of this study is     to determine whether the EOSS is also important in predicting post - operative outcome and     30-day mortality after metabolic surgery.   "
51826|NCT02607254|"     The purpose of this study is to assess safety and efficacy of treatment with pregabalin in     patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched     enrollment randomized withdrawal study that comprises 4 phases: a screening and selection     phase, a washout period from previous pain medication for enriched enrollment, an 8 week     single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.   "
51828|NCT02607228|"     This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2)      The Dose Escalation phase will evaluate the safety and tolerability of GS-5829 as a single     agent and in combination with enzalutamide, as well as determine the maximum tolerated dose     (MTD) of GS-5829 as a single agent and in combination with enzalutamide in participants with     metastatic castrate-resistant prostate cancer (mCRPC).      The Dose Expansion phase will evaluate the following:        -  In group 1, the efficacy of GS-5829 as a single agent in participants with mCRPC who          have progressed while receiving enzalutamide (may have also received abiraterone)        -  In group 2, the efficacy of GS-5829 combined with enzalutamide in participants with          mCRPC who have progressed while receiving treatment with abiraterone (may not have          previously received enzalutamide)        -  In group 3, the efficacy of GS-5829 combined with enzalutamide in participants with          mCRPC who have had Prostate Specific Antigen (PSA) progression, but not radiographic          progression, while receiving treatment with enzalutamide (participants may have also          previously received abiraterone)   "
51829|NCT02607215|"     Platinum Retreated in Patients with Platinum Sensitive mTNBC   "
51830|NCT02607202|"     Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in     chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two     best active single agent - carboplatin or gemcitabine - added to an innovative taxane back     bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational     initiative to improve the outlook of patients with cancer of unknown primary through     evaluation of novel chemotherapeutic regimens.   "
51831|NCT02607176|"     The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in     patients with diarrhea.   "
51864|NCT02606721|"     The objective of this study is to correlate various diagnostic measurements taken during an     escalating dose oral food challenge to the subject's response. This study will investigate     whether non invasive objective biomarkers can indicate a positive response to an escalating     dose OFC before a systemic reaction occurs.   "
51913|NCT02606071|"     The IRON-MPP is a prospective multicenter, observational registry designed to collect     clinical and device data from a large cohort of HF patients treated in clinical practice with     a CRT-D device with the ability to deliver Multi Point Pacing.      The purpose of the Registry is to collect data on how MPP-devices are being used by     physicians in order to better understand how to improve the clinical care of patients and     effectiveness of MPP therapy.   "
51832|NCT02607163|"     Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.     Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and     postoperative mortality. Aortic surgery is the most risky surgery that causes the     postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.      The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory     effects, respectively. Agents that attenuate renal vasoconstriction may have potential as     renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology     of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and     cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its     potential as a renoprotective agent. Furthermore, it has been already reported that     dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.      The aim of this study is to examine the association between preoperative dexmedetomidine     infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing     aortic surgery.   "
51833|NCT02607150|"     A prospective study designed to evaluate changes in tissue and cerebral oxygenation before     and following administration of blood for patients undergoing spinal surgery.      Red blood transfusions (autologous and allogeneic) are indicated to improve oxygen delivery     to the tissues and hence tissue oxygenation. Despite the presumed efficacy, there are limited     data to demonstrate changes in tissue oxygenation with the administration of blood.     Furthermore, the administration of both autologous blood from cell saver and allogeneic blood     can be associated with both acute and long-term deleterious physiologic effects which may     impact the perioperative course. As such, data are needed to clearly delineate the benefits     of transfusion during the perioperative period.   "
51834|NCT02607137|"     Holistic health is an integration and interaction of physical and psychosocial health.     Positive psychology is a science of happiness, which focuses on positive emotions and     personal strengths. It also is crucial component in family holistic health. Healthy diet can     help to achieve energy balance and healthy weights. Physical activity is believed to     contribute to physical and mental health, as well as social well-being. However, physical     inactivity was found to be a local and worldwide issue and most Hong Kong people are having a     sedentary lifestyle.      In view of the health challenges locally and globally, the new phase of FAMILY project will     focus to promote family holistic health with emphasize on the interaction and integration of     physical and psychosocial health. The investigator will initiate and develop a series     innovative training program with vigorous evaluation in order to evaluate the effectiveness     of the programs. The investigator hypothesize that the training programs would promote the     health awareness and the health of the participants   "
51843|NCT02607020|"     Fatigue is the most chronic and disabling symptom in multiple sclerosis patients.     Self-management physical exercise programs seem promising to allow patients to improve their     fatigue and their deconditioning. However, the effectiveness of such programs has been poorly     assessed until now. The objectives of the present study are to evaluate the relationships     between fatigue and physical capacity among slightly affected MS patients, and to carry on a     large trial to assess the effectiveness of a self-management exercise program in the same     patients. Sixty-four patients will be included and will be asked, after an educational     period, to perform at least three exercise sessions of more than 30 minutes each week, over a     period of three months. Patients will be splitted in two groups : one group will perform     endurance and resistance physical exercises, and the other one will perform relaxation     exercises with the help of soothing music. A regular coaching will adapt the exercises and     motivate the patients to continue the treatment. Assessors won't be informed of patients'     treatment. Four evaluations will be done, and will notably assess muscle strength, endurance,     fatigue and social participation.   "
53437|NCT02586129|"     Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety     and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.   "
51835|NCT02607124|"     In this research study the investigators want to learn more about the effects, both good and     bad, when the study drug Ribociclib is given after radiation therapy.      The investigators are asking people to be in this research study that have been newly     diagnosed with a high grade glioma, and the tumor has been screened for the Rb1 protein, and     have recently finished radiation therapy. Patients with a DIPG or a Bi-thalamic high grade     glioma do not need to have tumor tissue screened for the Rb1 protein but do need to have     finished radiation therapy.      Tumor cells grow and divide quickly. In normal cells, there are proteins called     cyclin-dependent kinases (CDK 4 and 6) that control cell division. Another protein Rb1 also     controls cell division and works to stop cells from dividing so they do not become cancer     cells. But in cancer, the CDK 4 and 6 proteins are out of control making the cells divide and     grow quickly. The study drug, ribociclib stops the CDK 4 and 6 proteins. When the CDK 4 and 6     proteins are stopped, the normal Rb1 protein can now work to slow cell growth. For patients     with HGG, to be in this study tumor tissue must have a normal Rb1 protein. The researchers     think that if the study drug is given soon after radiation therapy, it may help improve the     effect of the radiation in stopping the tumor from growing.      The study drug, Ribociclib is considered investigational as it has not yet been approved by     the United States Food and Drug Administration. The study drug has been tested in children     and adults with cancer in prior research studies.   "
51836|NCT02607111|"     This study evaluates the optimal dosage and safety of Dalteparin when used as an     anticoagulant for hemodialysis therapies.   "
51837|NCT02607098|"     The purpose of this study is to understand the experience of men and their partners when     diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills     they use to adapt to this diagnosis.   "
51838|NCT02607085|"     This study evaluates the management of subjects with Standard of Care (SOC) when admitted to     the Emergency Department (ED) with hyperkalemia (potassium value ≥ 5.5 mmol/L). Demographics     and medical history data, including previous ED visits and/or hospital admissions for     hyperkalemia and reason for current ED admission, will be recorded. Subjects who receive an     intervention/treatment for hyperkalemia will have study-related potassium values determined     at 30 minutes, 1, 2, and 4 hours after the start of treatment. Subjects who receive no     intervention/treatment during the initial 4-hour period will have a study-related potassium     value determined 4 hours after the baseline potassium measurement. Available data obtained as     part of SOC management will include physical examinations, vital signs, fluid intake and     urine output, ECGs, clinical laboratory data, and results of chest x-rays. Data regarding the     subject's chief complaint upon admission to the ED, the possible cause of the subject's     hyperkalemia, and admitting and discharge diagnosis will be recorded; the subject's overall     discharge summary will also be collected.   "
51865|NCT02606708|"     The primary purpose of this study is to determine the feasibility and tolerability of a     regimen of accelerated (hypofractionated) Intensity Modulated Radiation Therapy (AIMRT) to     the whole breast as part of breast preservation. In addition, the investigators want to     prospectively collect blood specimens to: assess TGF-β polymorphisms to identify potential     carriers at higher risk for post-treatment fibrosis; generate a blood specimen repository for     future studies of other relevant polymorphisms. The study investigators also want to     prospectively follow each treated woman yearly to assess long-term radiation sequelae of the     current regimen by using the LENT/SOMA scores.   "
51866|NCT02606695|"     A comprehensive approach to the evaluation of alignment in spinal surgery patients - through     preoperative planning, intraoperative assessment, and postoperative confirmation - has not     been well-studied. This study aims to assess the value of such planning through clinical and     radiographic outcomes.   "
51839|NCT02607072|"     Background: Evidence of high quality has suggested that acetylsalicylic acid (ASA)/aspirin     effectively reduces colorectal adenoma incidence and recurrence rate, and several randomized     controlled trials (RCTs) strongly indicate its potential to prevent colorectal cancer (CRC)     initiation and progression and to decrease cancer-related mortality. However the role of     aspirin supplied as an adjuvant agent in postsurgical CRC patients remains obscure, and a RCT     is warranted for clarification.      Aim: The APREMEC trial aims to investigate the potential preventative role of enteric-coated     aspirin (100 mg and 200 mg daily) against postsurgical recurrence and metastasis among Asian     CRC patients.      Design: The investigators hypothesize that this large-scale multicenter randomized     double-blind placebo-controlled trial will support that aspirin can reduce recurrence and     metastasis and improve survival in postsurgical non-metastasized CRC patients. The primary     endpoint of this trial is disease-free survival, and the secondary endpoints are 3-year and     5-year overall survival, the interactive effects of lifestyle including smoking and alcohol     ingestion, and adverse event rate. Eligible postoperative patients with non-metastasized CRC     will be randomized in this trial to 100 mg aspirin, 200 mg aspirin or placebo until     recurrence/metastasis, severe adverse event, death, or end of study, after standard adjuvant     therapy. Individuals with peptic ulcer, bleeding tendency, or previous or ongoing treatment     with aspirin or other anticoagulants will be excluded from this trial. Stratification factors     are gender, study center, cancer site, and tumor stage. After randomization, patients will be     followed up with evaluations at a 3-month interval while taking study drug.      Discussion: This study aims at investigation of aspirin's role as an adjuvant agent in     prevention of postsurgical CRC recurrence and metastasis. If results turn out to be positive,     Asian and global CRC patients will be greatly benefited, due to the fact that aspirin is     inexpensive, easily-accessible, and simply-administered, with well know and managed adverse     events.   "
51840|NCT02607059|"     Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo     or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a     non-interventional research regarding diagnosis and therapeutic approach   "
51841|NCT02607046|"     Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and     decreased blood flow to the legs. This may cause difficulty or pain with walking or other     activities that use leg muscles. Exercise may help improve blood flow in the legs and improve     the ability to walk. This research project will be conducted patients with PAD that require     revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation     and neuromuscular stimulation on leg blood flow, physical function, quality of life and     general health.   "
51844|NCT02607007|"     This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt,     cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each     participant will receive every treatment in this crossover design study.   "
51990|NCT02605070|"     Single center, prospective, open clinical study to determine the genomic imprint (epigenetic     modification) in a series of male infertility patients with alterations in their spermiogram     (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of     FSH ( follicle stimulating hormone) administration on these modifications and on male     infertility.   "
51846|NCT02606981|"     Municipal water networks within industrialized countries typically rely on centralized     treatment to manage piped water quality. Optimal water quality at the tap, however, requires     well-maintained piped distribution networks, and performs best when piped systems are fully     pressurized. In low-income cities such as Dhaka, water distribution networks are inadequately     maintained and typically supply intermittent service; as such, they are vulnerable to     recontamination during negative pressure events. Among populations accessing these types of     improved water sources in urban settings (e.g. shared taps), it is unknown if consistent     treatment to provide chlorinated water at the point of collection would have a significant     health benefit. Furthermore, almost all previous studies of water treatment interventions in     low-income countries have been unblinded with self-reported diarrhea as the main outcome,     casting doubt that reported impacts of water disinfection on diarrhea are not due entirely to     social desirability bias. Stanford University in collaboration with icddr,b will conduct a     randomized evaluation to assess the impact on access to automatically chlorinated water on     water quality and child health.   "
51847|NCT02606955|"     Clinical methods are fundamental in probing the DW. They must be supported by strict BIA     protocols. REST appears to be a (the) brilliant solution in solving the old problem of DW in     HD patients   "
51848|NCT02606942|"     Comparing the physical and sonographic findings of dancers with Chondromalacia patella to     non-dancers athletes.   "
51849|NCT02606916|"     This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of     Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic     esophageal squamous cell carcinoma patients.   "
51850|NCT02606903|"     To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501     administered subcutaneously via prefilled syringe or autoinjector   "
51867|NCT02606682|"     The purpose of this study is to determine the safety, tolerability and blood levels of orally     administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be     determined.   "
51914|NCT02606058|"     To establish if placental transfusion, using deferred cord clamping for 60 seconds or more     while holding the baby at or below the level of the placenta, will improve survival without     disability compared with standard early cord clamping in preterm babies less than 30 weeks of     gestation.   "
60612|NCT02492204|"     The main objective is the study of the role of IL33/ST2 axis in the pathogenesis of ARDS,     it´s value as prognosis marker and as therapeutic target.   "
51851|NCT02606890|"     The aim of this retrospective cohort study is to investigate the relationship between lesion     pattern on Magnetic Resonance Imaging (MRI) and atrial fibrillation in patients with acute     ischemic stroke. The investigators hypothesize that a pattern with lesions located in at     least two of the main arterial territories of the brain (left or right internal carotid     artery or posterior circulation territory) is associated with atrial fibrillation.      The investigators will retrospectively analyze clinical data and imaging lesion pattern of     1000 consecutive patients who were admitted to the Department of Neurology (Charite -     Universitätsmedizin Berlin, Campus Benjamin Franklin) and diagnosed with acute ischemic     stroke.      Acute stroke patients of this cohort underwent 3-Tesla MRI with Diffusion-weighted Imaging     (DWI) and Fluid-attenuated Inversion Recovery (FLAIR) sequences as well as standard 12-lead     electrocardiography (ECG) on admission and cardiac monitoring with automated arrhythmia     detection during stroke unit care lasting at least 24 hours.      If DWI and FLAIR lesions are located in more than one of the main arterial territories,     lesion pattern will be categorized as multiple lesion pattern.      The investigators hypothesize that a multiple lesion pattern will be detected more frequently     in acute stroke patients with atrial fibrillation than in patients without atrial     fibrillation.      The findings of this study might help to identify patients who could profit from extended     diagnostic work-up in order to detect atrial fibrillation.   "
51852|NCT02606877|"     The primary objective of this study is to investigate the effect of steady state pirfenidone     on the pharmacokinetics of nintedanib and its metabolites following oral administration of     2403 mg/day pirfenidone and to investigate the effect of steady state nintedanib on the     pharmacokinetics of pirfenidone at steady state following oral administration of 150 mg bid     nintedanib. There will be two cohorts of patients; the first one will consist of patients not     treated with pirfenidone or nintedanib, while the second one will consist of patients on     pirfenidone treatment.   "
51853|NCT02606864|"     This study will evaluate the effect of food on the absorption of the drug as well as safety     and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering     from chronic Chagas' disease when administered after a high-fat / high-calorie test meal     (American breakfast) compared to a fasting state. This study is required as part of the     clinical development of an age appropriate pediatric oral dosage form for the treatment of     Chagas' disease in endemic countries according to the recommendations provided by current     international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA     Note for Guidance on Oral Dosage Forms).   "
51854|NCT02606851|"     China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with     Gastroesophageal Reflux Disease   "
51855|NCT02606838|"     The purpose of this study was to determine if untrained subjects with diabetes could perform     basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and     palm lancings for Blood Glucose Meter testing.   "
51856|NCT02606825|"     This is a retrospective study to analyze the therapeutic results and clinical evolution all     patients diagnosed with AML and aged ≥ 60años or not candidates for chemotherapy intensive,     treated according to the different schemes available, including supportive care or     palliative.   "
51881|NCT02606487|"     The investigators aim to assess whether pulmonary MRI (hyperpolarised 129Xe ventilation     imaging [Xe-MRI]) can detect changes in ventilation defects in patients with CF before and     after treatment for a pulmonary exacerbation. The investigators will determine whether     changes seen using pulmonary Xe-MRI are associated with changes in pulmonary function     (spirometry, lung volumes, lung clearance index [LCI]) in patients with CF before and after     pulmonary exacerbation.   "
51882|NCT02606474|"     Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta     accreta is diagnosed during cesarean section &confirmed by pathology. All complications are     monitored in cases with placenta accreta and without.   "
51857|NCT02606812|"     The objective of the Project is to assess the effect of traditional food on the expression of     micro-ribonucleic acid (miRNA), which regulate genes related to glucose metabolism. It will     be a randomized experimental research. The research hypothesis is that consumption of     traditional food will resolve biomarkers of glucose-related anomalies. Students of The     Academic Division of Health Sciences (DACS for its initials in Spanish) will be invited to     participate and they will be divided randomly in two groups. The experimental group will     receive daily, five days per week, during three months, a lunch based on traditional     Mesoamerican food emphasizing local produce. The experimental group will be provided an     equivalent ratio of fast food from the school cafeterias. In both groups, at the start and     end of the protocol, values of lipid, glucose, reactive protein C, alanine aminotransferase,     and glycosylated hemoglobin profiles will be determined through spectrophotometric methods.     The levels of expression of five miARN involved in regulating genes related to glucose     metabolism (miR-320, miR-33a/b, miR-145, miR-335, and miR-124a) will be determined also by     means of PCR amplification techniques. Statistical analyses will be based on two-way ANOVA,     with a Dunnet's test procedure to find significance in measurements; significance will be set     at p ≤ 0.05.   "
51858|NCT02606799|"     This study evaluates the effect of extracorporeal removal of inflammatory mediators on the     systemic inflammation reaction of patients admitted to the intensive care unit following     elective esophagectomy. Half of the participants will be treated with an adsorption device     (CytoSorbents Adsorber), while the other half will be treated according to standard care.     Significant reductions of interleukin-6 plasma concentration, SOFA score and catecholamine     dosage in the intervention group are expected.   "
51859|NCT02606786|"     The purpose of this study is to examine the effectiveness of lumbopelvic stabilization     exercises on women who have undergone Caesarian sections on: 1) disability using the Modified     Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale     (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound     imaging, and 4) perceived improvement using the Global Rating of Change (GROC).   "
51860|NCT02606773|"     The aim of this study is to evaluate the bioavailability of Novo C Plus vitamin C     containing dietary supplement compared to licensed vitamin C medications. The novelty of this     product is the liposomal formulation.   "
51861|NCT02606760|"     The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in     patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and     concomitant mild to moderate plaque psoriasis.   "
51862|NCT02606747|"     This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients,     which will help us to understand the relationship between peripheral and central nervous     system, in order to early diagnosis and prevent the fall in DPN patients.   "
51863|NCT02606734|"     The purpose of this study is to evaluate the usability characteristics of DyeVert™ during     normal clinical use and to understand the amount of contrast media (CM) diverted from the     subject and saved over a total angiographic procedure.   "
54060|NCT02577978|"     The purpose of this study is to compare objective and subjective measures of knee stability     following total knee arthroplasty with a medial pivot design vs. a posterior stabilized     design.   "
51868|NCT02606669|"     Background and Aims: The 5:2 diet, a form of intermittent energy restriction, has been     popularized in Europe and USA. The rationale behind this approach is that two days of dieting     is potentially more achievable, yet long enough to reduce overall weekly energy intake.     However, this specific approach is lacking in evidence. Therefore, we are keen to investigate     the effectiveness of this form of intermittent energy restriction compared with a control     intervention (providing dietary and exercise advice only), in overweight, Chinese subjects,     for an intervention period of 12 weeks.      Design and Methods: This will be a randomized controlled trial, with 15 subjects in each arm,     for an intervention period of 12 weeks. Subjects randomized to the treatment group will take     three packets of a meal replacement product (Optifast®) per day during two consecutive     fasting days, and take a healthy balanced diet that meet estimated energy requirements for     the remaining five days. Subjects randomized to the control group will be given general diet     advice and allowed to eat ad libitum throughout the study period. Measurements and laboratory     tests will be done at baseline, 4 weeks and 12 weeks. Adherence to the dietary interventions     will be assessed at 4 weeks and 12 weeks using 7-day food diaries.      Significance: This will be the first study looking at an Asian population and will serve as a     pilot towards a larger randomized trial. If this approach is found to be safe, effective and     easier to adhere compared to the traditional continuous energy restriction, then it will be a     very valuable option in the treatment of obesity, which has become an increasing problem     globally including Singapore.   "
51869|NCT02606643|"     Once admitted, women who will have a transcervical balloon catheter inserted for induction     will be approached for participation in this study. If they agree to be take part in this     study (tape or no tape) they will be randomized into the study. After the balloon catheter is     inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this     is normal procedure.      Study related: If randomized to No Taping the foley will be positioned comfortable and not     placed to tension. For the Tension arm, tension will be placed on the balloon catheter,     which will then be taped to the patient's inner thigh. The tension will be assessed and     retaped as needed approximately every 30 minutes by the research and/or the nursing staff.   "
51870|NCT02606630|"     This open-label positron emission tomography (PET) study is designed to determine the effect     of ABT-555 on translocator protein expression level in participants with relapsing forms of     multiple sclerosis.   "
51883|NCT02606461|"     This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of     patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 245     total patients will be randomized to study treatment (selinexor or placebo).   "
51884|NCT02606448|"     This is a randomized, single blinded, standard of care controlled clinical trial. All adult     patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible.     The study compares pain control and opioid consumption in patients undergoing ACL     reconstruction between patients receiving liposomal bupivacaine and those who underwent a     preoperative femoral nerve block.   "
56744|NCT02542904|"     Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric     resection group and local mesenteric resection group.   "
51871|NCT02606617|"     With the improvement of living level, the incidence rates of diabetes, obesity, and     hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively,     according to the newly investigated data. The clustering of diabetes, obesity, hypertension     and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon     like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside     its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood     pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood     glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin     resistance, which may be related with the change of gastrointestinal hormones such as ghrelin     and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion     may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of     evidence-based medicine proof on the relationship between prokinetic drug and glycolipids     metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo     control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood     glucose and serum lipid in type 2 diabetic patients.   "
51872|NCT02606604|"     This study will seek to determine the benefits that FES-LE cycling has over cycling alone on     walking performance and quality of life in people with multiple sclerosis.   "
51873|NCT02606591|"     The goal of this research study is to learn about how brain activity, cognitive tests (tests     of participant's brain function), and stress hormones are related to taking part in a health     and wellness program in elementary-aged students.   "
51874|NCT02606578|"     Patients that are either scheduled to undergo or have undergone an achalasia procedure at the     Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather     information and determine if one of these procedures is superior to the other.   "
51875|NCT02606565|"     Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income     countries. Infections, including those affecting the umbilical cord (omphalitis) are a     significant factor in approximately a third of these deaths. In fact, the odds of all-cause     mortality are 46% higher among infants with umbilical cord infection than those without     infection. Five large randomized controlled trials in Asia and Sub-Saharan Africa have     examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (CHX)     on the umbilical cord on omphalitis and neonatal death. These studies show a consitent     positive effect of multiple applications on omphalitis but not on neonatal mortality. Whereas     there is mounting evidence for the effect of 7 day chlorhexidine application, there is no     data from Africa and only one study from Asia that examines the effect of a single     application of CHX as soon as possible after birth. In this single Asian study, CHX led to a     reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an     African setting to explore the effect of a single application, which is programmatically much     simpler to implement than daily application for 7 days. Therefore, the investigators' study     will compare umbilical cord cleansing with a single application of 4% chlorhexidine at birth     with dry cord care in both community and facility births on omphalitis and severe illness in     the neonatal period.      Methods: The chlorhexidine study is a community based, individually randomised controlled     trial conducted on 4,760 mother-infant pairs in Uganda. The primary outcomes are severe     illness and umbilical cord infection (omphalitis). Severe illness is defined as any illness     associated with at least one of the following danger signs observed by study research     assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or     unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in     death.      Discussion: This study will provide novel evidence, from a Sub-Saharan African setting of the     effect of umbilical cord cleansing with a single application of 4% chlorhexidine at birth in     both community and facility births.   "
51876|NCT02606552|"     Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using     percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus     aspirin or dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT     (dual-antiplatelet therapy)) in patient with coronary artery disease treated with     drug-eluting stent, accompanying atrial fibrillation.      Total of 670 patients [left atrial appendage occlusion registry with 100 ACP/ 570     anti-coagulation registry: (285 Dabigatran plus aspirin) and (285 Dabigatran plus     clopidogrel) therapy)] will be comparatively analyzed the safety and efficacy. Primary     endpoints were a composite of death, non-fatal myocardial infarction, stroke, systemic     embolism, and GUSTO bleeding (moderate to severe).   "
51877|NCT02606539|"     Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially     methotrexate and the investigators try to find a role of surgery plus methotrexate instead of     multiple doses and cycles of chemotherapy.   "
51878|NCT02606526|"     BCG vaccination may have non-specific effects (NSE) i.e., additional benefits on childhood     morbidity and mortality that are separate the vaccine's effect on the incidence of     disseminated tuberculosis. Though the available literature is mostly from observational study     designs, and is fraught with controversy, BCG vaccination at birth, in a high risk population     of HIV exposed children, may protect infants against serious infections other than TB. Yet,     other studies indicate that giving BCG later in infancy, when the immune system is more     mature, may offer even greater protection. The appropriate timing of BCG vaccination could     therefore be up for revision. This study will therefore compare BCG vaccination at birth with     BCG vaccination at 14 weeks of age in HIV exposed (HE) babies.      Methods: This is an individually randomized clinical trial in 2,200 HIV exposed infants. The     intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of     birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine at     14 weeks of age.      The main study outcomes include:        1. Severe illness in the first 14 weeks of life,        2. TNF, IL‑1b, IL-6 and IFN-γ in response to mycobacterial and non-mycobacterial antigens          and        3. Severe illness in the first 14-52 weeks and 0-52 weeks of life.      The study will be carried in two health Center IIIs and a health center IV in Uganda.      Implications: A well-timed BCG vaccination could have important additional benefits in HE     infants. This trial could inform the development of programmatically appropriate timing of     BCG vaccination for HE infants.   "
51879|NCT02606513|"     Tumors of the UUT are rare and usually presenting as micro- or macrohematuria either     symptomatic or asymptomatic. Rapid advances in CT technology accelerated the research into     the application of this new technology in the evaluation of the UUT and readily proved to be     superior to other imaging modalities. Nevertheless the increase in radiation dose is a major     issue of concern. Initial research into the utility of MRI in the evaluation of the UUT was     promising, yet the success of CT together with the cost, limited availability and the longer     duration of MR urography (MRU) examination, nearly halted the investigations into the     feasibility of MRU which is unfortunate as MRU is a safe alternative to CT.   "
51880|NCT02606500|"     The aim of the present study is to determine, whether clinical efficacy of 150 mcg of     Corifollitropin alfa is the same in normal weighing and obese women. Furthermore,     investigators want to determine whether oocytes retrieved from normal weighing and obese     women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular     level.   "
51886|NCT02606422|"     Primary progressive aphasia (PPA) is a neurodegenerative disease that affects first and     foremost language abilities. Mild cognitive impairment (MCI) is slowly progressive decline in     a single domain of cognition (e.g. language) not attributable to motor or sensory loss,     without impediment of social or occupational function. MCI can be an early sign of     neurodegenerative disease, or can be due to normal aging. When language is the prominent     affected domain in MCI, the person may later meet criteria for PPA or may progress to the     clinical syndrome of Alzheimer's dementia. Spelling, naming, and working memory (e.g.     repetition) are among the language abilities affected early in the course of PPA or     language-centered MCI, and different variants have distinct deficits in these domains. This     research project investigates the behavioral and neuromodulatory effects of transcranial     direct current stimulation (tDCS) during language therapy in PPA participants over time.     Anodal tDCS targeting the left inferior frontal gyrus (IFG) administered in combination with     language therapy is expected to be more beneficial when compared to language therapy alone.     It will 1) improve language performance or decrease rate of decline, 2) have better-sustained     effects at 2 weeks and 2 months post-treatment, and 3) produce generalization to untrained     language items and some other cognitive functions. Resting-state fMRI, diffusion tensor     imaging (DTI), and volumetric data are also collected to investigate changes in functional     brain connectivity associated with tDCS in individuals with PPA. A better understanding of     the therapeutic and neuromodulatory mechanisms of tDCS as an adjunct to language therapy in     PPA may have a significant impact on the development of effective therapies for PPA and MCI,     and may offer insight into ways of impeding neurodegeneration that may improve patients'     quality of life, as well as extend their ability to work and manage their affairs.   "
51887|NCT02606409|"     Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for     benzodiazepines and propofol, has been approved by the US Food and Drug Administration only     for use up to 24 h in mechanically ventilated patients. The investigators aim to compare     dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated     patients.   "
51897|NCT02606279|"     This study is designed to evaluate specific factors in mitochondria that may precipitate     premature aging and physical weakness in HIV patients. Angiotensin receptors 1 and 2 (AT1R     and AT2R) are found in virtually every cell type. This study will evaluate how the     relationships among these receptors in immune and skeletal muscle cells change with HIV, and     how these changes might trigger mitochondrial dysfunction, declines in muscle strength, and     cellular decline in people living with HIV.   "
51966|NCT02605382|"     The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a     chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment     protocol with a six-month follow-up.   "
51888|NCT02606396|"     Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the     United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with     esophageal cancer present with tumors which are not amenable to surgery and are treated with     chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is     dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking     tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2     months for swallowing to improve with this treatment.      Another method of shrinking esophageal tumors and allowing for better swallowing is     endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an     endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous     esophageal disease. This is a particularly attractive treatment option, as patients with     esophageal cancer usually undergo endoscopy on several occasions before starting treatment in     order to biopsy and evaluate the tumor.      The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC     related dysphagia in patients who are getting ready to start chemotherapy and radiation.      In order to do this the investigators are planning to invite patients who are already     undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo     cryotherapy after the diagnostic portion of the endoscopy has been completed. After the     cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2     and 4 weeks after cryotherapy.   "
51889|NCT02606383|"     This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the     new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea     pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between     16 and 60 years-old.      Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to     Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety and     tolerability of Dapaconazole cream 2% after multiple administrations.      Participants will receive either new intervention or active control during 14 consecutive     days, which will be followed by 2 follow-up visits.      Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy     endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will be     assessed by adverse events occurrence and laboratory exams evaluation.   "
51890|NCT02606370|"     Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait     using an unstable shoe (Intervention group) and a conventional stable control shoe (Control     Group).      Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients     with Low Back Pain.   "
51891|NCT02606357|"     Primary Objective:      -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes     patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin     glargine).      Secondary Objectives:        -  To evaluate the percentage of patients achieving target of HbA1c ˂7%.        -  To evaluate the change in fasting plasma glucose (FPG).        -  To assess the following safety criteria: hypoglycemic events, body weight changes, and          overall safety.        -  Describe the titration process: changes in glargine insulin dose at 3 months and 6          months, changes in the titration doses used (if any), and time to reach control.   "
51892|NCT02606344|"     The high rates of HIV infection in women have brought into sharp focus the problem of     violence against women. There is a growing recognition that women and girls' risk of and     vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities     violence against them in particular. The links between intimate partner violence and HIV/AIDS     are explained by biological as well as sociocultural and economic factors.   "
51969|NCT02605343|"     The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided     treatment when implemented into the pre-operative process for patients undergoing bowel     surgery, major urologic procedure, or major ventral hernia repair and requiring     post-operative acute pain management in an inpatient basis, as compared to a group of     subjects with the same attributes without the guidance of PGx testing (historical control     group). This study will also evaluate the frequency with which the standard analgesic care     plan is adjusted by test results.   "
51893|NCT02606331|"     Thirty six patients needs therapeutic extraction of the maxillary first premolars with     subsequent retraction of the maxillary canines will be divided randomly into two groups :     piezocision group and the ER:yttrium aluminum garnet (YAG) laser group. In each group,     piezocision or hard laser-assisted flapless corticotomy will randomly assigned to one side of     the maxillary arch at the first premolar region, and the other side served as the control.     Canine retraction will be initiated after completion of the leveling and alignment phase via     closed nickel-titanium coil springs applying 150 g of force per side, soldered trans-palatal     arch will be used as an anchor unit.      Pre- and post distalization dental casts will be evaluated to study rate of canine     distalization, canine rotation and anchorage loss over a follow-up period until a Class I     canine relationship is achieved. The levels of pain and discomfort will be self-reported     using a questionnaire with visual analog scales administered at four assessment times during     the first month after the minimally invasive procedure.   "
51894|NCT02606318|"     The purpose of this study was to clarify the effects on health-related QOL of occupational     therapy involving the adjustment of challenge-skill balance in the activity of elderly     clients.   "
51895|NCT02606305|"     This is a phase 1b study to assess the safety, tolerability, and preliminary anti-tumor     activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of     four regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin,     IMGN853 administered with pegylated liposomal doxorubicin or IMGN853 administered with     pembrolizumab.   "
51896|NCT02606292|"     Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy     has been the most common technique providing clear, real time video images of organs'     surfaces. However, this technique only images the surface and cannot effectively diagnose     diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been     developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases.     This technique can image very deep areas of organs, up to several centimeters; however, it     suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue     abnormalities that do not show mechanical properties that differ significantly from those of     normal tissues.      The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the     rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned     need.   "
51911|NCT02606097|"     The main purpose of this study is to examine whether regorafenib treatment can help people     with gastrointestinal stromal tumours (GIST) and have gene mutation on c-kit exon 17. The     safety of regorafenib treatment is also examined.   "
61479|NCT02480868|"     The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void     Filler in the single arthrodesis procedure.   "
51898|NCT02606266|"     Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory     deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop     deafness, some of whom will progress gradually to profound bilateral deafness.      No curative treatment is currently offered for this deterioration in hearing and management     involves the use of a hearing aid or cochlear implant. Many studies describe the utility of     antiviral treatment on the course of the deafness. These mostly involve neonates with     multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir     possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or     even improvement.   "
51899|NCT02606253|"     Broad Objectives: To determine the comparative efficacy of commonly employed strategies to     overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized     decompensated heart failure patients with hypervolemia      Specific Aims:        1. Compare the 48-hour weight change of either intravenous chlorothiazide or oral tolvaptan          compared to standard-of-care oral metolazone when combined with standardized loop          diuretic dosing for diuretic resistance in decompensated heart failure        2. Compare the adverse effects of electrolyte depletion and renal function changes between          intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral          metolazone when combined with standardized loop diuretic dosing for diuretic resistance          in acute heart failure        3. Pharmacoeconomic analysis of the direct costs of intravenous chlorothiazide or oral          tolvaptan compared to standard-of-care oral metolazone when combined with standardized          loop diuretic dosing for diuretic resistance in acute heart failure      The investigators will conduct a dual center, randomized, double-blind, double-dummy,     parallel design trial comparing: oral metolazone, intravenous chlorothiazide, or oral     tolvaptan, in combination with loop diuretics in 60 patients hospitalized for hypervolemic     decompensated heart failure and displaying loop diuretic resistance.   "
51900|NCT02606240|"     This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and     device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following     tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.   "
51901|NCT02606227|"     Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth     outcomes and may have long-lasting effects in the offspring.Financial incentives may increase     smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health     effects. This is a randomized open label study comparing financial incentives for smoking     abstinence with no financial incentives for smoking abstinence.Research objectives        1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant          smokers;        2. To explore the heterogeneity of efficacy according to individual characteristics:          socioeconomic status, social background, smoking characteristics, personality traits,          time and risk preferences to determine profiles of women which could benefit best from          this kind of intervention;        3. To provide a cost-benefit analysis based on the cost of newborn and children disease due          to maternal smoking during pregnancy.   "
51902|NCT02606214|"     The objective of the study is to evaluate the safety and tolerability of multiple doses of     TBA-354 in healthy subjects.   "
51970|NCT02605330|"     The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and     thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.   "
51971|NCT02605317|"     The aim of this study is to determinate outcomes of WhatsApp Messenger (a messaging program     for smart phones) usage for Communication Between Consulting Physicians and the Emergency     Physicians.   "
51903|NCT02606201|"     Stress urinary incontinence related to intrinsic sphincter deficiency (ISD) is a severe form     of incontinence that may have a major impact on the quality of life. The main treatment is     surgical and consists in the implantation of medical devices such as the artificial urinary     sphincter, adjustable continence therapy, compressive sling, or injection of bulking agent.      The investigator has developed a new therapeutic strategy for ISD that consist to implant     myofibers with their attached satellite cells (the main source of muscle progenitor cells) at     the vicinity of the striated urethral sphincter. The principle of this method relies on the     in vivo activation of satellite cells leading to the formation of regenerated myofibers     (myotubes) generating a distinct and tonic muscular activity . The proof of concept was     investigated in a Phase I clinical trial: Investigator found that the periurethral     implantation of myofiber strips around the urethra generated an electromyographic activity     improving urethral closure pressure in women with severe urinary incontinence associated to     ISD. In this previous study, the technique of myofiber implantation was invasive, as it     required a surgical approach and dissection of the urethra to place the myofiber. For the     clinical trial IPSMA, the investigator sought to optimize the myofiber transplantation     process using a method injection of myofibers core obtained by hydro-dissection. The     injection technique is performed percutaneously under fluoroscopic and endoscopic control and     does not require a surgical approach of the urethra.      This clinical trial is prospective, open-label, non-randomized, uncontrolled, single-center     for the first stage and multicenter for the second stage, of 13 months for each patient aims     to assess the efficacy and safety of IPSMA in the treatment of urinary incontinence in women     with ISD.   "
51904|NCT02606188|"     The purpose of this study is to determine whether the Modified High-flow nasal cannula is     effective in the oxygen of the patients undergoing bronchoscopy.   "
51905|NCT02606175|"     Patients who receive a kidney transplant have to learn in 10-14 days which anti-rejection     medication to take, how to take it ,... This learning process is attended by the nurses of     the ward. This study wants to measure the degree of medication knowledge, health literacy and     medication adherence of those patients.   "
51906|NCT02606162|"     The purpose of this study is to determine the outcomes of severe osteoporotic fractures     hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the     risk of mortality over 2 and 5 years.   "
51907|NCT02606149|"     Patients with metastatic cancer have a substantial symptom burden and may receive aggressive     care at the end of life. There is evidence that the use of chemotherapy near the end of life     is not related to its likelihood of providing benefit and the overuse of aggressive     anticancer therapies near the end of life may result in more toxicity than clinical benefit.     Moreover, proposing new lines of treatment after successive therapeutic failures may be a way     of avoiding discussion of prognosis and advance care planning. It has been proposed that     systems not providing overly aggressive care near the end of life would be the ones in which     less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the     first consultation between patient and oncologist is ruled in France by the first Plan     Cancer and the Dispositif d'annonce (announcement planning). Oncologists are supposed to     explain the diagnosis of cancer and to present a treatment plan. In routine practice for     metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and     its side effects are explained. The use of chemotherapy has been associated with the     worsening of two major competitive life-threatening conditions for cancer patients: cachexia     and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is     hardly explained in routine practice.      This study proposes to examine in a monocentric interventional prospective randomized trial,     the impact of a particular way for the oncologist to present chemotherapy at the diagnosis     stage on the easiness of timely chemotherapy interruption at the end of life. The main     objective is to determine whether or not the explanation of the potential role of anticancer     chemotherapy in worsening life-threatening conditions impacts the proportion of patients     receiving chemotherapy in the last 30 days of life compared with usual presentation.     Secondary objectives are to determine the impact of this communication strategy on overall     survival and other indicators of aggressiveness of care and palliative care resources use.      The hypothesis is that the intervention will allow 15% of patients receiving anticancer     therapy during the last 30 days of life, as compared to 30% in the control group.      The investigators expect that the intervention evaluated in this study will reduce the rate     of patients receiving chemotherapy during the last 30 days of life hopefully improving the     quality of end of life care. A secondary objective is overall survival and this study will     therefore verify that the intervention arm is not associated with poorer overall survival.     But more probably investigators expect patients in the intervention arm to have an improved     overall survival mainly link to a decrease in harms due to chemotherapy given near the end of     life and to better palliative care. In effect the hypothesis is that showing the     life-threatening risks associated with chemotherapy and thus reducing for patients the     importance of this treatment will leave room for improved palliative care as shown notably by     earlier and more frequent referral to palliative care specialists. If this trial is positive,     it will prove the capital role of patient-doctor communication in cancer care and that few     differences in communication strategy could improve end of life care and maybe even survival.     The impact on the oncology community would be major since the intervention could be easily     transposed in all practices at no additional cost. It would also emphasize the importance of     communication skills and human relationship in the very technical field of medical oncology.   "
51908|NCT02606136|"     This is a Phase 2, open-label, single arm trial of pamrevlumab (FG-3019) to estimate     pamrevlumab's safety and efficacy in non-ambulatory subjects with DMD.   "
51909|NCT02606123|"     The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In     Part I, patients will participate in single, multiple, and long-term dosing periods using     EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary     indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design,     dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at     80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after     their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior     to or concurrent with enrolling patients in Part II.      In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate     cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and     post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose     (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in     each cohort) will be enrolled.   "
51910|NCT02606110|"     The purpose of this study is to investigate the effect of the ReBuilder in the treatment of     individuals with breast cancer and chemotherapy induced peripheral neuropathy.   "
51915|NCT02606045|"     This is an outpatient, 24-week Phase III prospective, randomized, crossover trial comparing     recombinant von Willebrand factor (rVWF) and tranexamic acid (TA, Lysteda®) to minimize     menorrhagia in women with type 1 von Willebrand disease (VWD). The purpose of this Phase III     multicenter prospective, randomized, crossover arm trial is to compare recombinant von     Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in     women with von Willebrand disease.   "
51916|NCT02606032|"     The investigators will test the hypothesis that giving antibiotics prior to fecal transplant     therapy for active UC increases the proportion of patients in remission at the end of     treatment. The investigators will randomize patients aged 18 or over with active UC to     antibiotics (metronidazole 500mg, doxycycline 100mg, Terbinafine 250 mg, all twice daily for     two weeks); or identical placebo. At the end of two weeks the investigators will give all     patients fecal transplant therapy twice per week for eight weeks from the donor whose stool     showed most efficacy in the trial (donor B). Patients will complete a validated UC     questionnaire, have a flexible sigmoidoscopy to assess the degree of inflammation in the     colon and complete general and disease specific quality of life questionnaire as well as a     questionnaire on anxiety and depression. Patients will complete the same questionnaires again     at the end of treatment at week 9 when they will also have a repeat flexible sigmoidoscopy.     The main outcome that will be assessed is the proportion of patients in remission from their     UC at the end of treatment.   "
51917|NCT02606019|"     The burden of dengue infection has increased due to the current non-specific classification.     A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular     endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1)     and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in     differentiating severe dengue from non-severe dengue cases. The analysis between severe     dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two     categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at     the margin of the pre-determined p-value of less than 0.05.      Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue     from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF     and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and     liver function test (alanine aminotransferase and aspartate).   "
51918|NCT02606006|"     Thousands of canines are used for therapy in health care centers throughout the United States     as part of a volunteer therapy team, yet little is known about the outcomes provided by these     teams. Although many studies have been published, few used randomized, controlled formats to     identify whether canine therapy has an impact and any mechanisms by which any impact may     occur. The purpose of this study is use a randomized, controlled setup for canine     animal-assisted therapy (AAT) in patients undergoing inpatient physical therapy for stroke,     Parkinson's disease, or generalized weakness deconditioning to determine whether use of AAT     produces desirable outcomes, such as increased motivation, in patients.   "
51919|NCT02605993|"     The primary purpose of this study is to evaluate the safety, tolerability and efficacy of     multiple IV doses of ALXN1210 administered to complement inhibitor treatment-naïve patients     with PNH.   "
51920|NCT02605980|"     United Kingdom (UK) physical activity guidelines for older people state that All older     adults should minimise the amount of time spent being sedentary (sitting) for extended     periods and there is sufficient evidence to support a recommendation to reduce sedentary     behaviour in older adults, but it is not currently possible to suggest a specific time     limit. The aim of this study is to identify key physiological and psychological outcomes     influenced by acute periods of inactivity and what older people feel after these acute     periods of inactivity. The investigators' main objective is to determine, through direct     measurement and self report, the acute functional and cognitive effects of differing periods     of sitting time. A secondary objective is to inform older people, professionals and     organisations working with older people and policy makers on what duration of sedentary     behaviour will lead to adverse outcomes in older people. The investigators will recruit     ambulatory men and women aged 70 y and over who will be studied on three separate occasions,     approximately one week apart to complete sedentary bouts of 1 h, 2 h and 4 h in a randomised     crossover design. The investigators will explore the relationship between sitting time and     changes in lower limb explosive power(primary outcome) measured before and after each bout.     Secondary outcomes will include timed chair rise; Timed Up and Go; blood pressure; perception     of musculoskeletal comfort/pain, vitality; mood and cognitive function. The investigators     will also measure the stress hormone cortisol in samples of saliva taken at the start of the     sitting session, 1 h, 2h and 4 h later. Characterising the acute effects of sitting time in     older adults will enable the design of interventions to reduce sedentary time as well as     inform professionals and policy makers on what duration of sedentary behaviour will lead to     adverse outcomes.   "
51921|NCT02605967|"     The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001     versus investigator's choice of chemotherapy in patients with advanced NPC.      By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the     activation of a T cell mediated antitumor immune response   "
51922|NCT02605954|"     This study will evaluate the efficacy of switching to     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose     combination (FDC) relative to continuing on a baseline regimen consisting of     abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in maintaining HIV-1 virologic     suppression.   "
51923|NCT02605941|"     The purpose of this prospective study is to evaluate whether DNA methylation can be applied     in cervical cancer screening.   "
51924|NCT02605928|"     The study focuses on needle guidance in rheumatologic operations - glucocorticoid injections     inside joint capsules specifically. The main purpose of the study is to assess and validate     the clinical feasibility and performance of Bioimpedance Probe (BIP) Needles and assess the     benefits, drawbacks and risks related to use of the BIP Needles.   "
51925|NCT02605915|"     This is a Phase Ib, open-label, two-stage study with two active regimens in each stage     designed to evaluate the safety and tolerability of combination treatment with atezolizumab,     trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab     emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive     metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and     atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.   "
51995|NCT02604979|"     Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy, which     is performed in a head up position under CO2 pneumoperitoneum.      Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the     susceptibility to life threatening cardiac arrhythmias.      Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc     interval) during robotic-assisted laparoscopic gastrectomy.   "
51926|NCT02605902|"     Gilles da la Tourette syndrome (TS)* is a common chronic neuropsychiatric disorder     characterized by motor and vocal tics. In most adult patients, quality of life is     significantly impaired. TS, therefore, is a cost-intensive disease (in Germany: mean total     costs=€3404/year). Despite significant adverse effects, dopamine receptor antagonists were     recommended as first choice treatment for many years. Although efficacy could be demonstrated     only recently, today, behavioral therapy with face-to-face Comprehensive Behavioral     Intervention for Tics (CBIT) (including psychoeducation, habit reversal training,     function-based assessment and intervention, and relaxation training) is recommended as first     line treatment for tics. In Germany, however, dissemination of CBIT is restricted due to a     considerable lack of well-trained therapists. The aim of this study is to overcome this     deficiency by creating a new and sophisticated internet-delivered CBIT (iCBIT) program. In     addition, internet-delivered CBIT will shorten waiting time, will reach additional groups of     patients and will be - once developed and established - highly cost-effective (about € 100     vs. € 1450 for face-to-face CBIT). Investigators want to perform a multicenter, randomized,     controlled, observer-blind trial including 160 adult patients in order to demonstrate that 8     sessions (10 weeks) of iCBIT are superior to internet-delivered psychoeducation/relaxation in     adult patients with TS. Both immediate (1 week after end of treatment) and long-term effects     (after 3 and 6 months) will be evaluated.   "
51927|NCT02605889|"     This is a randomized clinical research, with triple blinded multicenter involving the Federal     University of Rio de Janeiro, through the School of Nursing Anna Nery, as a proponent and     research coordinator; and as a collaborative educational institutions, the Federal University     of Espirito Santo, represented by the Department of Nursing; and the Higher School of     Sciences of the Santa Casa de Misericordia de Vitoria, through the Master's Programme in     Public Policy and Local Development.      As Research, the study covers health units of the Municipal Family Health Maricá / Rio de     Janeiro, the Municipal Victoria Health / Holy Spirit, beyond the scope of Integrated Project     Research-Service (PIPA), linked to Nursing Anna Nery / Federal University of Rio de Janeiro.      The object of investigation is the effectiveness of acupuncture in nursing care in     complementary treatment of adult patients Diabetes Mellitus type II.   "
51928|NCT02605876|"     This study will evaluate the acute effects of vibration (whole body vibration and local     muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics     linked to osteoarthritis development in individuals with anterior cruciate ligament     reconstruction. Subjects will be randomly assigned to control (no vibration), whole body     vibration, and local muscle vibration groups, and the aforementioned characteristics will be     assessed prior to and following the respective interventions.   "
51929|NCT02605863|"     The purpose of this study is to examine the effect of androgen deprivation therapy through     administration of enzalutamide on preventing bladder cancer recurrences in patients with     non-muscle invasive bladder cancer (NMIBC).   "
51985|NCT02605135|"     The ability to determine the postmenopausal vaginal environment and the impact of pessary use     could help to maximize pessary therapy and non-surgical treatment for such a prevalent     problem.   "
51987|NCT02605109|"     This study aimed to analysis the characteristics of MERS transmission and the effect of our     institutional personal protective equipment on the controlling the MERS at a tertiary Korean     Hospital.   "
51930|NCT02605850|"     This study will determine the effects of beneficial compounds of plant foods, such as     pomegranate on cardiovascular health. This will be tested by asking healthy males to eat a     high fat ground beef patty with pomegranate juice (PJ), pomegranate extract (PomX) or water     and then measuring blood vessel dilation (endothelial function) by blood flow We also will     measure the amount of Nitric Oxide (NO) in your blood and urine samples and sugar and insulin     in blood. Healthy men have been chosen for this study because eating high fat hamburger     patties can easily mimic in them the condition that causes atherosclerosis. The results from     this study may help to explain how high fat foods can be harmful to the body and how     beneficial plant foods can have on cardiovascular function   "
51931|NCT02605837|"     A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the     histologic response and determine if any reduction in dysphagia is achieved.   "
51932|NCT02605824|"     This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma     that is complicated by mucus in the airway, as determined by CT imaging. The study is a     crossover design, which means that half the study participants will get 20% NAC in the first     7-day treatment period and placebo in the next 7-day treatment period; and the other half     will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment     period.   "
51933|NCT02605811|"     To investigate the response of temozolomide versus prophylactic cranial radiotherapy in     preventing brain metastases in completed or partial remission limited small cell lung cancer     patients.   "
51934|NCT02605798|"     Comparative randomized, single dose, three way three sequence two treatment partial replicate     crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400     mg Film Coated Tablets ( Multi-Apex Pharmaceutical industries, Egypt) versus Sovaldi 400 mg     Film Coated Tablets (Gilead Sciences International Ltd. Cambridge, United Kingdom)   "
51935|NCT02605785|"     This study is designed to learn more about overall tau burden in the brain of patients with     Progressive Supranuclear Palsy (PSP).   "
51936|NCT02605772|"     To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With     Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be     enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or     Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before     and after the interventions.   "
51937|NCT02605759|"     To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for     the treatment of esophageal squamous cell dysplasia.   "
51938|NCT02605746|"     This is two parallel studies to examine pharmacokinetic (PK), pharmacodynamic (PD), and     pharmacogenetic (PG) endpoints following short-interval therapy (10-14) daily doses without     dose reduction and interruption) with the ALK (anaplastic lymphoma kinase) small-molecule     inhibitor, ceritinib.      The Phase 0 study will investigate:        1. first recurrence GBM patients and        2. patients with CNS metastases from solid tumors such as, but not limited to, NSCLC          (non-small cell lung cancer) and melanoma.      The CNS (central nervous system) metastases Phase 0 is designed to identify PK effects (in     addition to PD, and PG effects on ALK-positive NSCLC metastases), while the GBM Phase 0 is     designed to identify PK, PD, and PG effects in all patients.   "
51939|NCT02605733|"     The purpose of this study is to characterize the normal brain function of premature infants     (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.   "
51940|NCT02605720|"     Mass drug administration with antimalarial treatment is a tool that can potentially reduce or     totally eliminate malaria parasite infections from a population.     Dihydroartemisinin-piperaquine (DHA/PPQ) given monthly for 3 months to the entire population     might be a good candidate for mass drug administration because the long acting PPQ exerts a     long post-treatment prophylactic effect against reinfection and relapse. The use of a     repeated dose of DHA/PPQ could lead to increased PPQ plasma concentrations and increased     cardiotoxicity. However, there is no data on a second course of treatment or on safety of the     drug administered in repeated monthly doses. The proposed project is a clinical trial to     assess the electrocardiographic safety of monthly DHA/PPQ (for 3 days at a time) for 3     months. The investigators aim to assess the safety of the drug to be used monthly in mass     treatment campaigns. Recommendations issued from this study will benefit health authorities     on Lihir-Island by setting the stage for a possible subsequent campaign to completely     eliminate malaria from the whole island. This study could be a crucial step to inform the     feasibility of drug-based strategies for eliminating malaria elsewhere in PNG, other     Melanesian countries and throughout the world.   "
51941|NCT02605707|"     Stroke is a frequently occurring and common diseases in nervous system,and most of the     survivors will remain disorders of motor,sensory and cognition function.Stem cell     transplantation provides a promising approach for rehabilitation. The main objective of this     study is to evaluate the efficacy and safy of the transplantation of autologous endothelial     progenitor cells in patients with chronic stroke.   "
51942|NCT02605694|"     Phase II study to evaluate the efficacy and safety of DR vs R-CHOP in subjects with     relapsed/refractory FL   "
51943|NCT02605681|"     The purpose of this study is to assess the relationship between midkine level and ACE-Ang II     induced endothelial injury in sepsis.   "
51944|NCT02605668|"     PROTECT-AD is a cognitive behavioral treatment study involving highly qualified     psychotherapeutic centers at seven German universities.      It is our goal to further investigate and optimize existing effective treatments of anxiety     disorders. In order to achieve this, the investigators want to investigate the effect of     extinction learning in an intensified psychological intervention on treatment outcome in     adults and children with anxiety disorders.      The intensified psychological intervention is characterized by a higher number of exposure     trials over a short time period. In the control condition the exposure trials take place in a     weekly interval, analog to standard care.   "
51945|NCT02605655|"     The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on     Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other     half received placebo.   "
52001|NCT02604901|"     The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a     reminder device (Pillbox), and the combination of the two on adherence in adult patients who     filled a prescription for oral medications to treat diabetes or hyperlipidemia.   "
51946|NCT02605642|"     To assess persistence of Inflectra in patients with Rheumatoid Disease (Rheumatoid arthritis     [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naive to biologics     or are switching over from stable Remicade to Inflectra. The main objectives of the study     are:        -  To evaluate real-life drug persistence in RA, AS, and PsA patients who are either          initiated with Inflectra™ as their first biologic, or who are switched from stable          Remicade™        -  To characterise the patient populations and drug usage patterns of RA, AS, and PsA          patients who are either initiated with Inflectra™ as their first biologic, or who are          switched from stable Remicade™        -  To assess the safety of Inflectra™ in RA, AS, and PsA patients who are either initiated          with Inflectra™ as their first biologic, or who are switched from stable Remicade for up          to 2 years   "
51947|NCT02605629|"     This study aims to evaluate the Impact of a topical Lotion, CG428, on permanent chemotherapy     induced hair and scalp disorders in Cancer survivors. This is a double-blind, single center,     randomized, controlled trial in breast cancer survivors.      Hair condition and parameters of 61 breast cancer survivors who were previously included in     DERMA study (a prospective cohort study to assess appearance changes due to breast cancer     treatment completed in July, 13th,2013) will be assessed.        1. Patients whose hair parameters are below the baseline as measured before the start of          the chemotherapy or        2. who complain from incomplete hair regrowth will be eligible to participate in the          randomized controlled trial.      Patients who agree to participant in the study will be randomly assigned to two parallel arms     (Arm 1: CG428/ Arm 2: Placebo). Patients will self-administer the study product or placebo     twice per day (morning, evening) for 6 months, for the efficacy assessment.      Primary endpoint was recovery of hair thickness 6 months after intervention as assessed using     Folliscope 4.0.      Secondary endpoints included hair density at 6 months after intervention, distress due to     chemotherapy induced alopecia, scalp skin parameters (water and sebum). Patient-reported hair     quality improvement, body image and quality of life, and time to first visible improvement     based on global photographs of hair and nails.   "
51948|NCT02605616|"     Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo   "
51949|NCT02605603|"     This project is expected to elucidate role of different therapeutic interventions: SRT in     comparison to ERT in influencing immune aspects of GD pathology, as well as bone involvement.   "
51950|NCT02605590|"     This study will be performed to assess the safety, tolerability and PK of escalating inhaled     AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive     days in healthy subjects.      A thorough review of safety data will be conducted after completion of each dose level per     subject and prior to both, moving to the next dose level in Part 1 and commencement of the     multiple dose Part 2.   "
51951|NCT02605577|"     The purpose of the project is to investigate the status of nutrition management of late     preterm infants in the member hospitals in the Beijing association of preterm infants, and     set up the systemic nutritional management of late preterm infants, Including parenteral     nutrition and enteral feeding. And to compare the differences of growth and complications of     these infants between groupings applicationg and not applicating the systemic nutritional     management of late preterm infants,and to validate its feasibility and validity.   "
52005|NCT02604849|"     The identification of all cases (44 patients) was carried out from the database of     microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the     identification of controls, in case of neutropenic patients, all colonized patients that were     included during the study period did not receive any decolonitation treatment; in case of     non-neutropenic patients it was studied a paired control by the presence of risk factors that     indicated the beginning of decolonitation treatment.   "
51952|NCT02605564|"     The central hypothesis of this proposal is that a gluten-free diet introduced shortly after     diagnosis can reverse or arrest islet destruction in children and adolescents with type 1     diabetes mellitus (T1DM). The specific aims are to determine the effects of a gluten-free     diet on 1) endogenous insulin production and 2) the corresponding gut flora of children with     new-onset type 1 diabetes. This is a randomized placebo controlled clinical trial testing the     effect of altering the gut microbiome via a gluten-free diet on endogenous insulin production     as a measure of the pace and severity of islet destruction at the time of diagnosis of type 1     diabetes. The project entails eliminating gluten from the diet of the intervention group and     comparing bacterial gut flora and endogenous insulin response with those in a control group     up to one year following the diagnosis of type 1 diabetes. The proposal introduces a new     potential etiology for type 1 diabetes in humans: the Bacterial Hypothesis. The short term     goal is to identify specific islet-preserving microbiome changes induced by eliminating     gluten from the diet of patients recently diagnosed with type 1 diabetes. The long term goal     is to develop these changes into effective and safe strategies that can allow patients with     type 1 diabetes to achieve permanent insulin-independence.   "
51953|NCT02605551|"     The goal of this study is to demonstrate the use of osteopathic manipulative therapy (OMT) in     the effective management of hypertension. The investigators hypothesize that by     addressing/correcting somatic dysfunctions with OMT, the sympathetic overdrive that could be     the root cause of the elevation in blood pressure will be downregulated. If this is the case,     then an effective therapy for hypertension could indeed be regular OMT treatment. This could     also result in the avoidance of potentially harmful antihypertensive medications which     comprise a majority of the current therapeutic strategy in the treatment of hypertension     (along with lifestyle modification). A third implication of the results of this project could     be a reduction in the progression of this disease. Under the current standard of care, a     majority of hypertensive patients only experience a worsening of the disease over time under     the current therapeutic guidelines.   "
51954|NCT02605538|"     CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients     according to European consensus. The aim of the study is to vaccinate as many patients as     possible and to follow up whether immunization has been complete.   "
51955|NCT02605525|"     The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of     Immunoglobulin A nephropathy (IgAN)   "
52002|NCT02604888|"     The purpose of this study is to determine whether the Hair Loss Prevention Lotion named     MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata.   "
51956|NCT02605512|"     Breast radiotherapy RT used until the 1990s was clearly responsible for increased mortality     due to long term cardiac complications. Since the 2000s, improvements have appeared in dose     distributions to organ at risks such as heart, but now, little is known on the risk of     potential cardiac impairment in this population, in particular for chemotherapy naive     patients. Based on the state that clinically detectable cardiotoxicity is generally preceded     by subclinical cardiac dysfunctions, the aim of the BACCARAT study (BreAst Cancer and     Cardiotoxicity induced by RAdioTherapy) is to evaluate whether adjuvant 3DCRT induces cardiac     toxicity that could be detected in the first two years after treatment based on a global     approach with repeated analysis of subclinical functional and anatomical cardiac lesions in     myocardial and coronary levels and circulating biomarkers.   "
51957|NCT02605499|"     This study examines the impact of UV-C light disinfection as an adjunct to routine daily and     discharge patient room cleaning on patient infection and colonization with hospital     associated bacteria.   "
51958|NCT02605486|"     The purpose of this study is to test the safety and effectiveness of the investigational     drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor     positive breast cancer.   "
51959|NCT02605473|"     The goal of the first phase of this clinical research study was to find the highest tolerable     dose of decitabine and peginterferon alfa-2b that can be given in combination to patients     with melanoma. The first phase was completed but the study did not progress to the second     phase.      The goals of the second phase of this clinical research are to learn if decitabine and     peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are     more effective and/or better tolerated.   "
51960|NCT02605460|"     The purpose of this study is to evaluate the disease free survival and the overall survival     in patients with acute leukemia in first or second complete remission after administrating a     CXCR4 antagonist, as a chemo sensitization strategy, plus chemotherapy as the conditioning     regimen for autologous or allogeneic hematopoietic stem cell transplantation (HSCT).   "
51961|NCT02605447|"     The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to     assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a     SYNERGY Stent System.   "
51962|NCT02605434|"     The purpose of this study is to determine whether the gastric retentive Accordion Pill™     Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate     release Carbidopa/Levodopa in reducing motor fluctuations such as off time in advanced     Parkinson's Disease patients.   "
51963|NCT02605421|"     This is a phase II single center study to administer two courses of myeloablative     consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC)     rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy     (independent of this study). Ideally, patients should begin consolidation chemotherapy no     later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended     to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.   "
51964|NCT02605408|"     The purpose of this study is to record and analyze the profile and outcome of cataract     patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL)     implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian     tertiary medical centers.   "
51965|NCT02605395|"     This is an open-label, randomized, single dose, two-sequence, two-periods crossover study,     separated by 7 days washout interval from the first Study Drug Administration. This study is     conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release     (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each     to healthy adults fed under conditions.      In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR     tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to     receive the treatment that they did not receive in Period 1.      PARIET is a registered trademark of EISAI Co. Limited.   "
51967|NCT02605369|"     Universal coverage of good quality facility based care globally could prevent nearly 113,000     maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet,     only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably     low coverage of facility based births could explain, in part, the high maternal and perinatal     mortality estimates in Uganda. While multiple studies have examined factors associated with     this low utilization of health services around the time of birth, there is inadequate     implementation research exploring the best systematic methods that could promote uptake and     scale up of facility based births. This study will therefore examine the effect of an     intervention package (peer counselling by pregnancy buddies on facility based births, mobile     phone messaging promoting facility based births and provision of mama-kits) on the frequency     of facility based births and perinatal mortality. The study, a cluster randomized community     based intervention trial in post-conflict Northern Uganda, will provide data crucial in     framing national policy regarding measures to promote the use of health facilities.   "
51968|NCT02605356|"     This study will be conducted in 2 parts. The phase 1b part will be an international, phase     1b, open-label, dose-escalation assessment of radium-223 dichloride administered with     bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint     of the phase 1b part is to determine the optimal dose of radium-223 dichloride in combination     with bortezomib/dexamethasone for the Phase 2 portion of the study.      The phase 2 part will be an international, phase 2, double-blind, randomized,     placebo-controlled assessment of radium-223 dichloride versus placebo administered with     bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization (1:1)     in the phase 2 part will be stratified by:        -  Prior bortezomib treatment (yes, no)        -  Prior treatment (1 prior line of treatment, >1 prior line of treatment) Approximately 30          subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study and          approximately 196 subjects will be enrolled in the phase 2 part of the study.   "
51988|NCT02605096|"     This pilot study aims to test the feasibility and work flows associated with using MRI as the     initial imaging modality in the investigation of patients presenting with suspected scaphoid     fracture.      This pilot will be used to inform the design of a study that will aim to evaluate whether the     proposed intervention is likely to generate cost-savings whilst improving or maintaining     overall patient quality of life and satisfaction.   "
51972|NCT02605304|"     People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of     the infection when they are treated with sofosbuvir. However, in some instances, treatment     with sofosbuvir-containing therapy does not work. It is not known if treating people with     sofosbuvir again (retreatment) after it did not work the first time will work. There is an     important need to understand retreatment options in those instances. This study is being done     to see if two different regimens, ledipasvir with sofosbuvir and ribavirin for 12 weeks     (Group A) and ledipasvir with sofosbuvir for 24 weeks (Group B) are well tolerated in     HCV-infected persons where previous treatment with sofosbuvir failed. This study will also     look at the safety of each regimen and how well the combination treatment of     ledipasvir/sofosbuvir works in people who have cirrhosis (scarring of the liver) or HIV.   "
51973|NCT02605291|"     This study will investigate the effect of dietary macronutrient manipulation on glycogen     (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The     investigators will investigate the hypothesis that manipulating the macronutrient content of     the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation     during exercise.   "
51974|NCT02605278|"     This study evaluates whether the implementation of an integrated clinical program for chronic     musculoskeletal pain and depression behave better clinical outcomes than the usual approach     in primary care   "
51975|NCT02605265|"     The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of     participants will receive capecitabine alone together with neoadjuvant CRT, followed by a     cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed     by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after     the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.   "
51976|NCT02605252|"     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with     sequential treatment of pegylated interferon alpha-2b and NAs.   "
51977|NCT02605239|"     58 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental     School, Universidad de Chile, were included in the study. Those patients were bleaching and     included in this study and signed a consent form. The patients were treated with 10%     carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject with verbal instructions     for 3 weeks with daily applications of 1 hour according to manufacturers indications , before     and after this procedure was applied again the OHIP-Esthetics , PIDAQ and OES questionnaire     form, had 30 minutes to answer it, were completed before , immediately after and one month     control post-bleaching procedure.   "
51978|NCT02605226|"     This trial is going to evaluate tumor control and quality of life in patients with prostate     cancer treated with radiotherapy or cryoablation.   "
52006|NCT02604836|"     This study will investigate participant satisfaction (including compliance, preference,     tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or     osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on     study treatment is 6 months, and the target sample size is 1776 individuals.   "
52007|NCT02604823|"     This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive,     interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following     48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500     individuals.   "
51979|NCT02605213|"     Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that     involves intra and extra hepatic biliary system. There is no curative treatment for this     disorder. Supportive and conservative treatments are the most common therapies that used for     this disease. Although treatments such as ursodeoxycholic acid (UDCA) are recommended in some     situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic bacteria     such as cholestridium difficile as pathogenesıs of PSC, so use of antibiotics is recommended     for treatment of these patients. Therefore according to the great role of anaerobic bacteria     such as cholestridium difficile in pathogenesis, antibiotics such as metronidazole and     vancomycin can be counted as recommended therapies in PSC. In addition some studies     correlated this effect of vancomycin to its immunomudulatory effect the cause reduction of     inflammation in biliary system. But with all this detail there is no finality about     effectiveness of antibiotic therapy and accordingly in this study the investigators compare     oral vancomycin effect versus placebo in primary sclerosing cholangitis patients.      In this double blind clinical trial 30 primary sclerosing cholangitis patients that divided     in two 15 persosns group with Block Randomization method. in this study one group receive 250     mg oral vancomycin every 6 hours and other group receive placebo.      The study duration is 12 weeks . The baseline laboratory tests and 1 month and 3 months after     treatment concept of; Alkaline phosphatase, ALT, AST, GGT and serum total bilirubin and     clinical manifestations such as tiredness, itching and probable adverse effects such as     hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red     man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.   "
51980|NCT02605200|"     The purpose of this study is to determine the influence of post-transplant diabetes on     medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to     18 years of age and their families.   "
51981|NCT02605187|"     The ability to predict pain and then apply modified treatment protocols has been limited.     Current practice is for physicians to select standard post-operative pain treatment protocols     without patient consultation. This study hopes to determine if patient's involvement in     analgesic drug/dosage selection can optimize pain relief while minimizing related side     effects. This could result in a more patient-centered care model and individualized     perioperative analgesic treatment protocols based on patient's preferences, needs and     expectations.   "
51982|NCT02605174|"     This is a prospective randomized, double-blind, placebo-controlled study in subjects with     disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).   "
51983|NCT02605161|"     The purpose of this study is to evaluate the blood brain barrier in the striatum of patients     that have other types of movement disorders compared to patients with Parkinson's Disease     that are receiving similar treatment, to determine if a there is a disruption of the blood     brain barrier in patients with Parkinson's Disease.   "
51984|NCT02605148|"     To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism     in subjects with one or several islet autoantibodies without and with dysglycemia at     baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty     acids and probiotics.      Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will     be evaluated at baseline, and during follow-up by glucose tolerance tests.   "
52003|NCT02604875|"     The circadian rhythm of copeptin will be examined in healthy subjects.   "
51991|NCT02605057|"     Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to     compare and examine the amount of the drug in the upper layer of the skin with that of     Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty     adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in     the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet®     ointment will be applied to multiple test sites on the back of healthy Japanese male adults     and the trial is designed to compare the amount of each of the active ingredients at steady     state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of     calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of     tape stripping.   "
51992|NCT02605044|"     The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI     ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in     second line treatment of patients.   "
51993|NCT02605005|"     The aim of this study is to investigate the relationship between the patient positioning in     the beach chair position with consequential arterial pressure changes and their influence on     regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in     one group of patients and interscalene block in the second group of patients.   "
51994|NCT02604992|"     The primary objective of this study is to evaluate the comparative bioavailability of a test     product of dronabinol oral solution administered under fed conditions to the reference listed     drug (RLD) administered to participants under fed and fasted conditions.      The secondary objective is to compare the onset of detectable dronabinol concentrations     between dronabinol oral solution and the RLD.   "
52033|NCT02604485|"     The purpose of this study is to evaluate the safety and clinical pharmacology of a single     dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia     associated with congenital hyperinsulinism.   "
51996|NCT02604966|"     At the end of 2012, the Institute of Tropical Medicine in collaboration with National     Institute of Malariology Parasitology and Entomology (NIMPE) conducted a study in Quang Nam     province, central Vietnam, to assess the efficacy of the national DHA-PPQ regimen for the     treatment of uncomplicated P. falciparum malaria infections, both in adults and in children.     Results showed that about 30% of the study participants were parasitaemic at day 3. Parasite     clearance rate was estimated at 6.2h, which was comparable to figures from Pailin, Cambodia,     where artemisinin resistance were previously reported . However, results from this study have     to be interpreted bearing in mind that: (i) the age-based drug dosing scheme used has been     criticized as insufficient to clear parasites and (ii) DHA-PPQ drugs used (Artecan™),     Vietnam, are not produced under Good Manufacturing Practices (GMPs). However, those results     prompted the NMCP and WHO to declare Quang Nam, Binh Phuoc, Dak Nong, and Gia Lai provinces     as a Tier I area (credible evidence of artemisinin resistance) in May 2013. By end of 2014     a fifth province, Khanh Hoa, was declared Tier I (Dr Hong, Personal Communication). Except     for the south-eastern province of Binh Phuoc, artemisinin resistance has never been confirmed     with an artemisinin based monotherapy in Central Vietnam.      Therefore, in order to confirm artemisinin resistance in Central Vietnam , a study with oral     artemisinin-based monotherapy, using WHO prequalified AS and DHA-PPQ and recommended dosing     scheme of 4mg/kg/day for AS and DHA, is needed. In the arm where study participants are     treated with 3 days of AS monotherapy, treatment will be followed by an additional 3-day     course of DHA-PPQ to effectively clear all parasites.      The aim of the present study is to confirm artemisinin resistance in Central Vietnam by     assessing P. falciparum clearance time and rate after AS monotherapy (WHO recommended     dosage). The investigators will conduct a two-arm open label, randomized study, with one arm     receiving AS monotherapy for 3 days + 3-day of DHA-PPQ, and a second arm receiving 3 days of     DHA-PPQ.   "
51997|NCT02604953|"     Wills Eye Hospital Glaucoma Research Center will conduct a 1-year prospective study to assess     the ability of a Short Duration Transient Visual Evoked Potential (SD- tVEP) and a     Steady-State Pattern electro-retinogram (PERG) vision testing system to detect visual     dysfunction in patients with ocular hypertension. The study aims to assess the reversibility     of retinal ganglion cell (RGC) dysfunction after administering intraocular pressure (IOP)     lowering treatment. The investigators hypothesize that SD-tVEP and PERG testing will help     develop better treatment for glaucoma patients by increasing understanding of the     physiological relationship of IOP and RGC in glaucomatous injury.   "
51998|NCT02604940|"     The purpose of the study is to determine whether a single bolus dose of dexmedetomidine     administered during bariatric surgery has any effect on the amount of narcotic pain     medications required by an individual after surgery. Patients who undergo weight loss surgery     will be randomized into two groups - group one -dexmedetomidine group and group two- control     group. Both groups will receive a standard anesthetic. Control group will receive weight     based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen     (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based     dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic     pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The     Patient will then awaken after surgery in post anesthetic recovery unit and be given a     patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain     reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the     electronic health record ( routine practice) in the two groups and compared for pain medicine     requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score, respiratory     rate, heart rate, blood pressure oxygen saturation and respiratory rate. All will be recorded     at 30,60,90,120 and 240 minutes in the electronic medical record in PACU and compared between     the two groups . All the data - Intra operative and Post -operative - Post Anesthesia Care     Unit ( PACU) data will be retrieved from the electronic Medical record (EMR). All     intra-operative data is automatically computed into the patients EMR. All PACU data is     routinely entered into the EMR by the PACU nurse including the PCA data.   "
51999|NCT02604927|"     Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and     therefore acidotic environment) in their upper-body muscles, particularly in high-intensity     disciplines. Previous studies from our group have shown that upper-body exercise is very     sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional     supplements capable of increasing buffering capacity. In line with this, have shown that     upper-body muscle groups benefit more from artificially induced alkalosis than lower-body     muscle groups. Although β-alanine appears to be an interesting and potential ergogenic     supplement for paralympians, no study to date has assessed its potential in wheelchair     athletes.In this study, we will evaluate the effects of β-alanine supplementation on     upper-body performance in wheelchair athletes.   "
52000|NCT02604914|"     An Open-Label Study in Healthy Male and Female Subjects to Identify the Concentration that     Provides Optimal Bioavailability of Levodopa Infused Subcutaneously via a Pump System; and to     Compare the Bioavailability of Levodopa/Carbidopa Solution to that of Levodopa/Carbidopa     Intestinal Gel (LCIG), Infused via a Naso-Jejunal Tube   "
52004|NCT02604862|"     While the process of fibrosis is essential for normal wound healing, an excessive and     uncontrolled 'fibrotic' response can result in impaired tissue structure and function. In     other words, affected 'fibrotic' tissues are unable to heal back to normal and therefore     don't work as effectively as they normally would.      In the case of the lung, fibrosis can occur across large parts of the lung such as in     conditions like Idiopathic Pulmonary Fibrosis (IPF) and sarcoidosis or it can occur in much     smaller patches such as around the borders of some lung tumours. At the moment the     investigators don't fully understand the mechanisms of fibrosis and so therefore cannot     monitor or treat these conditions as effectively as the investigators could. Despite the     significant global financial burden of these diseases, treatment options are very limited and     monitoring of disease progression remains a real challenge.      In an effort to address this problem, the research team have designed and synthesised an     imaging agent (FIB ONE) that can detect fibrosis in the lung. FIB ONE will be used at very     low concentrations in patients with a lung condition characterised by excessive activity of     the fibroproliferative pathway either scheduled for a routine bronchoscopy or elective     surgery. FIB ONE will be administered directly into the lungs during a bronchoscopy procedure     and images of the lungs will be analysed. As part of this study, the research team's novel     endomicroscopy detection system will be compared to equipment that is routinely used in the     NHS when imaging the FIB ONE probe.   "
52008|NCT02604810|"     This study was designed to determine a dose of weekly subcutaneously administered Immune     Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%)     that produces steady-state AUC of total IgG that is non-inferior to that of the regularly     administered intravenous dose of Immune Globulin Injection (Human), 10%     Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency     subjects. This study was also designed to determine steady state trough total IgG levels     after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety     and tolerability of IGSC 20%.   "
52009|NCT02604797|"     Cesarean section may result in great trauma and postoperative pain. Besides incision pain,     uterine contraction pain is another source of postoperative pain after cesarean section. In     clinical practice, a large amount of uterine contraction agent is routinely applied after     cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage,     which also causes great uterine contraction pain. Acute pain is the risk factor of chronic     pain, and may postpone the recovery from labour and influence the quality of life of     parturient. Though various analgesia modules have been attempted, more than 20% parturients     still experience severe postoperative pain, and pain management after cesarean section     remains a challenge to anesthesiologists.      This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on     patient-controlled intravenous analgesia after cesarean section.   "
52010|NCT02604784|"     Single center, open label, non-randomized, single-arm, repeated single dose study to explore     the efficacy, safety, and Overall Response Rate (ORR) of cisplatin, oxaliplatin and     doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients (men     and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in     primary cancers of peritoneum.   "
52011|NCT02604771|"     This study is an epidemiological non-interventional trial that aims to evaluate standard     daily practice in managing patients with arterial hypertension. The trial only records     real-life clinical practice with no additional diagnostic or monitoring procedures.      The study is purposed to collect the following Egypt-specific epidemiology data on     hypertension: demographic data, patients' characteristics, and patients' management/treatment     in order to reach its rationale.   "
52012|NCT02604758|"     The aim of the study was to determine the effect of the psychiatric nursing approach based on     the Tidal Model on coping and self-esteem in people with alcohol dependency.   "
52013|NCT02604745|"     The main objective of this project is to determine intermediate-term echocardiographic     outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical     risk who have undergone mitral valve surgery for degenerative mitral regurgitation.   "
52014|NCT02604732|"     The study is designed to assess the need to stop Aspirin before laparoscopic inguinal hernia     repair. It will consist of 2 groups: patients who continue to take Aspirin and patients who     stop Aspirin 1 week before the surgery. Randomization will be by closed envelope method. The     surgeon will be blinded for the usage of Aspirin. Primary outcome is the rate of     post-operative seroma or hematoma within the fist 24 hours after surgery. Secondary outcomes     are post-operative pain at regular intervals, post-operative seroma and hematoma after 24     hours and other post-operative complications.   "
52015|NCT02604719|"     The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and     Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic     oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk     for post partum hemorrhage   "
52016|NCT02604706|"     Background. A common alternative treatment for substance abuse is ear acupuncture. The aim of     the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety,     sleep, drug use and addiction treatment utilization in adults with substance abuse. Method.     Adults with substance abuse and psychiatric comorbidity were randomly assigned to either of     two variants of auricular acupuncture - The National Acupuncture Detoxification Association     protocol (NADA) or a local protocol (LP) - or relaxation training (controls). Primary     outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity Index     (ISI) with assessment before treatment and follow-ups after five weeks and three months.     Secondary outcomes were drug use and addiction service utilization.   "
52027|NCT02604563|"     In this study the investigators will incorporate a wide range of clinical variables     associated with aging to determine whether they are associated with mutation status     independent of chronologic age. Clinically, aging can be operationalized using geriatric     assessment, which entails a comprehensive multi-dimensional assessment of the health of an     older adult, including measures of comorbidity, polypharmacy, functional status, cognition,     depression, falls, social activities and social support. Given that aging is heterogeneous,     geriatric assessment allows greater specificity for aging than chronological age alone.   "
52028|NCT02604550|"     The objective of this study is to compare the pain control benefit of two different types of     nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.   "
52017|NCT02604693|"     This study will provide important results for each aim, while also providing an integrative     transcriptional and epigenomic profile of CBD.      In Aim 1 the Investigator will define genome-wide epigenetic alterations of CBD, by     determining genes that are DM in pivotal immune cells, in the target organ (CD4+ BAL cells)     in CBD compared to BeS and healthy controls. In addition, the Investigator will determine the     impact of Be exposure on the methylation profile of CBD and BeS cells compared to each other     and normal controls. This information will be used to define DM regions, genes and their     networks.      Using the cases and controls from Aim 1, we will evaluate the gene-expression from these same     subjects in Aim 2 to define functional epigenetic loci based on DE in CD4+ BAL cells with and     without Be exposure. The Investigator will also integrate ENCODE/RE methylation, histone     modification, and chromatin accessibility data as well as our genome-wide association study     (GWAS) data to prioritize epigenetic marks and networks for confirmation and validation in     Aim 3. In Aim 3, the Investigator will test the generalizability of their findings, explore     the potential of methylation marks as biomarkers of disease in PBMCs and determine if change     in methylation of these targets with AZA or folic acid affects key immune and regulatory     pathways in a second set of CBD and BeS subjects. Throughout the Aims, the Investigator will     use both fresh CD4+ T cells to directly assess disease relevance and Be-stimulated cultured     CD4+ T cells (compared to unstimulated cultured T cells) to assess the impact of     environmental exposure .   "
52018|NCT02604680|"     The objective of the study is to compare the safety and efficacy of multiple formulations of     BLI1100 to a control group and placebo in treating patients with moderate-severe acne     vulgaris.   "
52034|NCT02604472|"     To investigate whether the additional induction chemotherapy (IC) to concurrent     chemoradiotherapy (CCRT) was able to improve overall survival (OS) and disease-free survival     (DFS), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for     locoregionally advanced NPC.   "
53504|NCT02585245|"     This research study will compare two different screens for nutrition risk in patients who are     in the hospital. We will be comparing the ThedaCare Nutrition Risk Screen to see if it is as     good and consistent as the standard NRS 2002 Nutrition Risk Screen.   "
52019|NCT02604667|"     The purpose of this study is to better understand the causes of stroke in people with cancer.     Active cancer increases the risk of stroke. The investigators do not know exactly why this     occurs but one possible reason is that people with cancer may have thicker blood than people     without cancer. Thick blood can sometimes cause blood clots to form in the heart, which can     then travel to the brain and cause stroke. This study is being done to help figure out why     this and other causes of stroke occur in people with cancer. The investigators expect that     information from this study will help doctors to more effectively prevent and treat stroke in     individuals with cancer.   "
52020|NCT02604654|"     The purpose of the prospective study is to evaluate the effectiveness and safety of     Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more     than sixy hospitals all over China.   "
52021|NCT02604641|"     Objective of the study is to determine the influence of dietary supplementation with coenzyme     Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a     placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD)     receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with     improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be     used. Various skin parameters will be evaluated before the supplementation (the baseline),     after 6 and after 12 weeks of supplementation. To evaluate the photoprotective potential of     CoQ10 the minimal erythema dose (MED) will be determined before (the baseline) and after 12     weeks of the supplementation.   "
52022|NCT02604628|"     The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship     intervention on protocol adherence of moderate-severe community-acquired pneumonia.   "
52023|NCT02604615|"     A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent     radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive     chemoradiotherapy is the standard regimen in Western countries for patients with esophageal     cancer who can't receive surgery or reject surgery. But in China because of its severer toxic     reaction, most of patients had to discontinue treatment at the halfway way. Thus, the     chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to     its characristic of low toxic reaction.      The purpose of this study is to confirm the efficacy and safety of the different cycles(two     cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma     radical concurrent chemoradiotherapy. A total of 60 patients will be accrued from China     within 2 years. The primary endpoint is overall survival and the secondary endpoints include     progression-free survival, response rate, pathologic complete response rate and adverse     events.   "
52024|NCT02604602|"     Objective is to analyze a possible association of coagulation factors peripartal with the     occurrence of postpartum hemorrhage.   "
52025|NCT02604589|"     Rib fractures are common injuries in accident patients and can be associated with significant     pain during recovery. If poorly controlled, pain from splinting due to rib fractures can     result in difficulty in breathing leading to incomplete expansion of lung, and even the need     to put a patient on a ventilator to help them breathe. Therefore, pain control is critical in     managing patients with rib fractures. To date, many studies have shown the effectiveness of     continuous intercostal nerve blockade (a slow release of pain medications at the site of     injury that prevents the transmission of pain signals). This approach has never been studied     in a randomized fashion in rib fracture patients, and has never been compared to     patient-controlled narcotic pain medication, commonly used at many hospitals. The purpose of     this study is to evaluate the effectiveness of the placement of an elastomeric infusion pump     (a small, external, wearable balloon used to deliver medication over time) attached to a     continuous infusion catheter or soaker catheter (a tube which releases the pain medication     through tiny holes in it, right at the site of injury) to deliver local anesthetic medication     to reduce pain caused by two or more rib fractures.   "
52026|NCT02604576|"     Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of     fixed-dose combination of bromopride and simethicone versus isolated bromopride on research     participants diagnosed with functional dyspepsia.   "
52030|NCT02604524|"     The biggest challenges for glycemic control during the day time involve meals and exercise     variations, which are impacted by age, fitness level, duration, intensity and history of     exercise. Meal variability has the benefit that meals are typically announced and quantified.     Glucose control around exercise, on the other hand, is more complicated if the patient     doesn't announce a change in activity level.   "
52031|NCT02604511|"     This research study is studying a drug called ibrutinib as a possible treatment for untreated     Waldenstrom's Macroglobulinemia (WM).   "
52032|NCT02604498|"     This is a single center, open-label, non-randomized, 1:1 parallel control and single dose     administration study design. Healthy subjects will be matched to moderate hepatic function     impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which     matches healthy with normal hepatic function according to the of subjects with impaired     hepatic function as, after enrollment of subjects with moderate impaired hepatic function     (Child-Pugh B，7-9). Hepatic function impaired group and control group both receive orally     single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before     and after the administration to perform pharmacokinetic analysis and safety observation.   "
52035|NCT02604459|"     Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip     fracture and this complication is independently associated with increased morbidity,     mortality, length of hospital stay, and placement in long-term care institutions. To date,     the only intervention shown to be effective at minimizing postoperative delirium is a     proactive geriatric consultation. This prospective randomized clinical trial will randomize     160 adults, aged 65 years or older, to either optimized general anesthesia or usual general     anesthesia care for hip fracture surgery to determine if the optimized anesthesia management     reduces the severity of postoperative delirium.   "
52036|NCT02604446|"     This study will provide knowledge about the use of long-acting opioids for pain relief after     primary knee arthroplasty. The investigators will compare depot tapentadol, depot oxycodone     and placebo for effect on pain relief and side effects. The three study groups reflect the     three different postoperative pain regimens that have been used the last years at St. Olavs     Hospital, so investigators know that no patient will receive an inadequate pain treatment.     The purpose of the study is to find which of the three treatments that gives the best pain     relief with the least amount of side effects. The results will be of use for postoperative     pain treatment for knee arthroplasty, but also for other types of major surgery. Similar     studies that are not sponsored by pharmaceutical industry have not been published yet.   "
52037|NCT02604433|"     This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to     determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC)     versus placebo plus BSC in adults who require regular red blood cell transfusion due to     (β)-thalassemia.      The study is divided into the Screening/Run-in Period, double-blind Treatment Period,     double-blind Long-term Treatment Period, and Post-treatment Follow-up Period.   "
52038|NCT02604420|"     Mortality in the major thrombotic microangiopathies (TMAs), TTP and aHUS, exceeds 90% unless     rapidly diagnosed and appropriately treated. TMAs complicate 10-20% of allogeneic bone marrow     hematopoietic stem cell transplants (alloHSCT), conveying inferior survival. Multiple     etiologies have been proposed for these transplant-associated TMAs (TA-TMAs), but once     infection, graft vs. host disease (GvHD), and drug effects have been ruled out, most are     treated as TTP-like disorders using plasma exchange (PEx). But PEx has no impact on mortality     in this setting. Clear definition of the pathophysiology of the TA-TMAs is required to guide     effective treatment. Investigators hypothesize that an aHUS-type TMA, related to     dysregulation of the alternative complement pathway, is involved and will be characterized by     elevated plasma levels of C5b-9 and detectable C5b-9 deposition in bone marrow sinusoidal     vessels. Investigators further hypothesize that treatment with inhibitors of terminal     complement components will reverse the TMA in vivo, and block endothelial cell damage in our     in vitro model systems. The data investigators generate from this observational study of     TA-TMAs should enable prediction of their development prior to overt clinical manifestations,     and guide appropriate therapy.   "
52039|NCT02604407|"     The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and     37.5 mg) given to participants daily in the morning compared to placebo in the treatment of     adults aged 18 to 55 years diagnosed with ADHD.   "
52040|NCT02604394|"     Coronary obstruction by an occlusive thrombus complicating a ruptured or eroded     atherosclerotic plaque is the most frequent pathologic substrate of acute myocardial     infarction (AMI).      Timely restoration of perfusion and thereby myocardial salvage is the single most important     objective in the management of patients with ST segment-elevation myocardial infarction     (STEMI).      To address these uncertainties, our study aims to evaluate the role of RT in patients who are     most likely to benefit from it (thrombus grade 4 and 5) using a sensitive, quantitative, and     reproducible parameter; CMR-derived myocardial salvage. also, to determine whether Rheolytic     Thrombectomy (RT) before conventional PCI to the culprit vessel as compared to conventional     PCI (with or without MTA) results in improved myocardial salvage; and to identify clinical     and angiographic determinants of any difference observed between both treatment groups.   "
52041|NCT02604381|"     The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine     Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on     osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index     Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the     knee.   "
52042|NCT02604368|"     The purpose of this study is to determine whether treatment of sickle cell patients with     docosahexaenoic omega-3 acid (DHA) is effective in prevention of acute sickle cell crisis.   "
52043|NCT02604355|"     This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending     dose and multiple-ascending dose, adaptive parallel study to investigate the safety,     tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral     administration in healthy participants and chronic hepatitis B patients.   "
52083|NCT02603835|"     The primary objective of the study is to collect confirmatory data supporting the safety and     effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI)     patients who have undergone successful percutaneous coronary intervention (PCI) with stenting     within six hours of experiencing AMI symptoms.   "
52044|NCT02604342|"     This randomized active-controlled multicenter Phase III open-label study will evaluate and     compare between treatment groups the efficacy of alectinib versus chemotherapy in     participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy     and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to     evaluate and compare between treatment groups the central nervous system (CNS) objective     response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed     by an Independent Review Committee (IRC).   "
52045|NCT02604329|"     Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for     chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing,     limits mucositis severity and associated pain. As its use is recommended in the treatment of     radio induced mucositis in adults, the level of evidence in pediatric studies does not allow     a precise treatment protocol. The investigators present here the protocol of a feasibility     study in the haemato-oncology department of the Children University Hospital of Toulouse,     with the view to a future efficacy study.   "
52076|NCT02603926|"     The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a     possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).   "
53537|NCT02584816|"     This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the     manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).   "
52046|NCT02604316|"     The proposed study will address the effect of developed novel food products through     processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability     and gut health using in vivo studies and validating new in vivo approaches.      Specifically in this protocol the investigators will address, in a short human intervention     study the effect of a potentially satiating product on appetite, appetite biomarkers,     particularly the influence on gut microbiota, tolerance and safety of the products in healthy     obese and overweight participants in free living conditions.   "
52047|NCT02604303|"     Abdominal aortic aneurysm (AAA) disease is an abnormal bulging of the main abdominal artery,     which is the called the abdominal aorta. The purpose of this observational study is to     identify whether a blood biomarker protein RhoA can predict which small AAA patients may need     surgery in the future.      Participating patients will receive an ultrasound and blood draw. The patients will be     divided into expanding and stable aorta groups after determining each patient's aortic     expansion rate. The blood RhoA levels and aortic expansion rates between both groups would     then be compared to look for any relationships.   "
52048|NCT02604290|"     The purpose of this study is to determine whether the kinesio taping method is effective in     the treatment of chronic (more than six months duration) low back pain.   "
52049|NCT02604277|"     The purpose of this study is to learn the environmental and psychological factors that impact     suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to     identify treatments to reduce the suicidal behavior and improve quality of life through a     6-week group-based intervention program.   "
52050|NCT02604264|"     To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC)     patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end     caps.   "
52051|NCT02604251|"     This is a multicenter, randomized, prospective, controlled study in patients having bilateral     breast reduction. Objectives of the study are to evaluate the safety and efficacy of the KLOX     BioPhotonic WoundGel System compared with the ones of Silicone Sheets in the treatment of     surgical wounds.   "
52052|NCT02604238|"     The primary aim of this study is to evaluate whether mid dose (safe dose) of Alteplase in     addition to standard treatment with heparin (LMWH) in patients with pulmonary embolism (PE)     at intermediate risk, it is effective to reduce:        -  right ventricular dysfunction        -  pulmonary hypertension 24 hours and 7 days after the treatment        -  PE recurrence to 7days and 30 days after the treatment without increasing the incidence          of bleeding intra-extracranial   "
52053|NCT02604225|"     A phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with     periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasound-guided     prostate biopsy (Pain-Free TRUS B).   "
52054|NCT02604212|"     Patients with HBeAG positive, chronic Hepatitis B Virus (HBV) infection will receive either     ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety     and efficacy.   "
52055|NCT02604199|"     Patients with chronic Hepatitis B Virus (HBV) infection will receive either ARC-520 or     placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.   "
52056|NCT02604186|"     Hereditary spastic paraplegias constitute a heterogeneous group of diseases with the common     predominant feature of spasticity of the lower limbs. The clinical picture is composed of     difficulty walking, exaggerated deep reflexes, pathological reflexes such as the Babinski     sign, sphincter disturbances and various degrees of weakness as well as sensory disturbances.      Spasticity is the symptom that provoques greater incapacity. Although there have been recent     advances in the genetic and pathogenic characterization of SPG there is scarcity of     therapeutic options. The Botulinum Toxin (BTx) is a well established treatment for movement     disorders such as cervical dystonia, blepharospasm, and arm spastic following stroke.      Therefore, the investigators propose the execution of a randomized, double-blind,     placebo-controlled, crossover study to evaluate the efficacy of the treatment with Btx over     SPG patient's gait. The primary outcome measure will be gait velocity with the 10 meter     walking test 8 weeks after injection. Each participant will be submitted to one injection     session of Btx and one of placebo (consisting of sterile sodium chloride), each one separated     by a period of 6 months. The primary and secondary outcomes will be evaluated by a blind     investigator 8 weeks after each injection session.   "
52057|NCT02604173|"     This study is designed to be the first to examine the novel drug budesonide for prevention of     acute mountain sickness in comparison to acetazolamide and in the context of rapid ascent to     high altitude. The investigators will accomplish these objectives with a prospective, double     blinded view of a large population of hikers who are ascending at their own rate in a true     hiking environment.   "
52084|NCT02603822|"     The investigators' overall objective with this study is to determine performance     characteristics of small intestine permeability measurement using 13C mannitol and 12C     (regular) mannitol.   "
52058|NCT02604160|"     This study is not intended to treat anemia of chronic kidney disease but to determine the     safety of the study drug, LY3113593.      The study will also evaluate how much of the study drug gets into the blood stream, how long     it takes the body to remove the study drug, and what effect the study drug has on the body.      The study consists of up to three parts. Participants may only enroll in one part.     Participants will receive up to four injections of LY3113593 or placebo into a vein. The     study will last up to about 26 weeks including screening and follow-up.   "
52059|NCT02604147|"     Investigate the effects of Inspiratory Muscle Training on the physical performance and     cardiorespiratory variables of wheelchair basketball players.   "
52060|NCT02604134|"     This pilot trial compares conventional restorations with a new strategy based on the medical     management of caries using silver nitrate and fluoride varnish with no restorations.   "
52061|NCT02604121|"     Prospective study of diagnosis validation of a cytological technique. 200 patients with oral     cavity cancerous and precancerous lesions will be enrolled.      A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex®     Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A     microscopic double blind reading will be performed. A biopsy sampling will be carried out in     accordance with current strategy of screening. The brushing diagnosis quality will be     compared to the biopsy which is the gold standard.   "
52088|NCT02603770|"     The objective of this study is to compare laboratory tests profiles of a botanic drug     XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy     male volunteers between 18 and 50 years of age.   "
52062|NCT02604108|"     This training program is a part of Happy Family Kitchen Movement Project, which is a     community-based research project with 3 main components for data collection - training     programs, community-based family interventions and public education events. The training     program involves various organizations, including non-government organizations and schools     across districts in different regions of Hong Kong.      In the study, the investigators would use training programs as a capacity building method and     an essential media delivering the holistic health knowledge (positive psychology, physical     activity, healthy diet) to the public. The project team will provide training program for the     participants, including: (i) train-the-trainer workshops for the social service workers, who     will conduct community-based family intervention programs; and (ii) train-the-trainer     ambassadors for the volunteers who may assist to implement health-related activities for the     public.   "
52063|NCT02604095|"     Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.   "
52064|NCT02604082|"     Randomized clinical trial, conducted in the Intensive Care Unit of the Hospital de Clinicas     de Porto Alegre from october 2011 until november 2015 .   "
52065|NCT02604069|"     A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an     adjunct to the current monitoring method - would be a tremendous improvement in detection of     early postoperative flap ischemia and, in turn, increase flap salvage and survival. In this     study, the investigators aim to examine the accuracy and reliability of measuring     interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an     objective method of detecting postoperative flap tissue ischemia in patients undergoing free     flap-based reconstructive surgery.   "
52066|NCT02604056|"     Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full,     active intervention (featuring educational outreach offered to each prescriber and team     members in the home) or standard quality improvement supports (including online audit and     feedback reports for each prescriber in the home). The 'standard' quality improvement     supports represent 'usual care' as these are to be launched province-wide; a concurrent     control arm with no exposure to a quality improvement intervention is not feasible.   "
52067|NCT02604043|"     This is a pilot prospective cohort study of the incidence of supraglottic pH readings.   "
52068|NCT02604030|"     Our objective is to identify the possible changes of three-dimensional scapula movement     during arm elevation in women after breast cancer surgery and subjected to a physical therapy     intervention. Also to evaluate pain, upper limb function and quality of life. Methods: Will     be evaluated 25 women with a clinical diagnosis of breast cancer and 25 healthy controls     women with no history of musculoskeletal disorders of upper limbs and matched with age and     body mass index. Two pre-surgical evaluations in the month prior to surgical treatment of     breast cancer and two post-surgical assessments are going to be assess: the first, after 4     weeks after surgery, when patients have received 8 sessions of physical therapy in upper     limb; the second, after 8 weeks after surgery, when patients completed 16 sessions of     physical therapy for shoulder complex . In each evaluation, bilateral scapular kinematics     will be analyzed by an electromagnetic tracking device during arm elevation in scapula plane,     in breast cancer group. Range of motion will by assessed by a digital inclinometer and muscle     strength by a hand held dynamometer. Also, pain will be assessed by visual analog scale and     upper limb function by DASH questionnaire. Quality of life is going to be evaluated by 36     questionnaire -item Short Form Health Survey (SF36).   "
52069|NCT02604017|"     This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with     Genotype 1 hepatitis C virus infection without cirrhosis   "
52070|NCT02604004|"     The objective of this research is to check whether the test drug (lamivudine in the form of     coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in     the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres     under fasting condition.   "
52071|NCT02603991|"     Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve     stimulators for children and adolescent with refractory epilepsy.   "
52072|NCT02603978|"     The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a     brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander     and social norms intervention are effective at reducing alcohol use and sexual-related     behaviors among college men mandated to receive an alcohol intervention by their university.   "
52085|NCT02603809|"     The main objective of the study is to explore the effects of ERA - at different dose     strengths - on the efficacy, safety and tolerability in subjects with essential hypertension   "
74133|NCT02315417|"     The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of     pyoderma gangrenosum (PG).   "
52073|NCT02603965|"     This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission     tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate     cancer undergoing surgery to remove the entire prostate and some of the tissue around it     (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the     lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal     cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body     where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing     them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805     PET/CT can accurately detect prostate lesions and determine whether they are cancerous or     benign, which may minimize the need for prostate biopsies.   "
52074|NCT02603952|"     The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852     when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety     and tolerability of a single dose of MEDI8852 alone in adult subjects with acute,     uncomplicated influenza caused by Type A strains.   "
52075|NCT02603939|"     Osteoarthritis (OA)is a painful and disabling disease, predicted to be the fourth largest     cause of disability worldwide by 2020. It commonly affects the hip or knee ultimately     resulting in total joint replacement. In order to assess disease progression and plan     surgery, x-rays are taken as part of routine practice. However x-rays provide limited     information about formation of substructures and changes occurring during progression of     disease. The proposed study aims to invite patients with OA of the hip or knee to participate     in detailed examinations of their pain and their painful joint through interviews, blood and     urine samples taken, MRI magnetic resonance imaging)and donating their waste tissue after     joint surgery (all of old joint). Informed patient consent will be sought in all cases.   "
52077|NCT02603913|"     Pregnancy complications like pre-eclampsia (PE), pregnancy induced hypertension (PIH),     intra-uterine growth restriction (IUGR) and preterm labor (PTL), (i.e. the major part of     complications in pregnancy) are related to an impaired endothelial function. Endothelial     dysfunction accounts for altered vascular reactivity, activation of the coagulation cascade     and loss of vascular integrity. Nitric oxide (NO), a free radical molecule derived from     L-Arginine by NOS (Nitric Oxide Synthase), is an endogenous endothelium-derived relaxing     factor influencing endothelial function. In the placental circulation, endothelial release of     NO dilates the fetal placental vascular bed and thus ensures feto-maternal exchange. The     impaired endothelial function in pregnancy complications originates from production of     inflammatory and cytotoxic factors by the ischemic placenta and results in oxidative stress     and an altered bioavailability of NO. Measurement of endothelial function using peripheral     artery tonometry and determination of ROS (reactive oxygen species) and RNS (reactive     nitrogen species) using Electron Paramagnetic Resonance (EPR) gives an idea of the oxidative     stress that took place and the degree of endothelial dysfunction that occurred during     pregnancy.   "
52078|NCT02603900|"     The study is a prospective randomized controlled trial comparing local infiltration of     analgesia in the knee joint and adductor canal catheters for postoperative analgesia     following a primary Total Knee Arthroplasty (TKA).   "
52079|NCT02603887|"     The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to     control intermediate- or high-risk smoldering multiple myeloma (SMM). The safety of this drug     will also be studied.   "
52080|NCT02603874|"     The current method of incision localization in many surgical procedures requires a doctor to     reference a medical image, such as an X-ray, to judge where on the body an incision should be     made. However, the precise information of the scan is not shown on the patient's skin.     Surgeons commonly use palpation to locate the point of incision. They may feel for the area     directly or find landmarks under the skin and estimate the location from there. This can be     challenging due to the difficulty of feeling and distinguishing each vertebra, especially for     new surgeons, since palpation is a skill derived through experience.      If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the     fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer     to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the     patient to radiation. Many fluoroscopic images may be required in a single procedure. The     purpose of this study is to test the efficacy and benefits of a new medical device that will     aid in radiological localization. The hypothesized outcome would be smaller incisions, faster     localization and a reduction in fluoroscopy use.      By identifying the efficacy of this new medical device, Target Tape, there is the potential     outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and     a reduced chance in surgical error and the associated costs.      Target Tape is a non invasive device that is in a grid format that is placed against the     subject's skin. The grid pattern will then appear on the medical imaging scan. The medical     practitioner can correlate device grid on the body to the medical scan image to make their     incisions in more accurate locations.   "
52081|NCT02603861|"     This study will evaluate the effect of single doses of LY3154207 on the amount of time it     takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much     LY3154207 gets into the blood stream and how long it takes the body to remove it. Information     about any side effects that occur will be collected. Each participant will complete four     study periods, which will last a total of about 8 weeks.   "
52082|NCT02603848|"     Morphine is now the most commonly used opioid in children for pain management even though the     safety of morphine use in children is a primary concern for parents as it is perceived to     have more associated risks. Ibuprofen and other Non-Steroidal Anti-Inflammatory Drugs     (NSAIDs) have also been shown to be effective for the management of postoperative pain with     fewer associated adverse effects. However, there have been concerns that utilization of     ibuprofen alone may lead to inadequate pain management. Evidence of whether ibuprofen is     equally effective as morphine for postoperative pain control in pediatric inguinal surgery is     lacking and needs to be further explored as a measure to potentially reduce opioid exposure     in children. To determine which drug is more effective for relieving post-operative pain,     this trial will compare the effectiveness of ibuprofen and morphine at reducing     post-operative pain, and the amount of analgesic use required post-surgery.   "
52254|NCT02601560|"     A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety,     Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of MEDI6012 in Subjects with     Stable Coronary Artery Disease   "
52086|NCT02603796|"     Facial scans of newborns will be performed before and after implementation of respiratory     support devices such as nasal CPAP. 3D scanned images will be processed by Fisher & Paykel     Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.   "
52087|NCT02603783|"     Reflux is common, especially after large meals. In general, this can do no harm. However, if     reflux occurs often and causes troublesome symptoms and or complications, it is called     gastroesophageal reflux disease (GERD). Long exposure to gastric acid causes the mucosa of     the esophagus to loose its integrity, which is thought to lead to the symptom of heartburn.     Several food products can also impair the esophageal mucosa integrity and thereby influence     reflux symptoms. One of these products is capsaicin, the pungent ingredient of red peppers.     Use of capsaicin often leads to worsening of complaints in patients with GERD and can cause     symptoms in healthy volunteers, possibly due to its effect on the mucosal integrity.      In this study the investigators want to investigate the effect of capsaicin infusion on     mucosal integrity. The investigators will evaluate mucosal impedance and the histology of the     esophageal mucosa. In addition, the investigators also aim to assess the involvement of the     TRPV1 receptor by evaluating the possible release of neuropeptides in the esophageal mucosa.   "
52089|NCT02603757|"     This is a pilot study to test whether there is an association between baseline Vitamin D     levels, Vitamin D supplementation and survival in patients with stage III colon and stage     II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage     II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled.     Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly)     Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D     levels will be checked throughout supplementation then followed for 5 years with occasional     Vitamin D testing and surveying in order to collect information on recurrence and survival     outcomes.   "
52090|NCT02603744|"     The goal of this study is to determine safety and tolerability and of intra-ovarian injection     of adipose derived stromal cell in women with premature ovarian failure and to study the     preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.   "
52091|NCT02603731|"     This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU) and     to identify risk and preventive factors associated with development of delirium.      Especially, the investigators want to investigate if an imitated natural light/dark cycle     influences frequency of delirium.   "
52092|NCT02603718|"     The purpose of this study is to investigate the efficacy of a simple and easy to use tool     that can extract relevant attention-related markers - Brain Engagement Index (BEI) from     ongoing EEG. During standard rehabilitative physical therapy sessions.   "
52093|NCT02603705|"     The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in     opioid-experienced patients with moderate-to-severe chronic noncancer pain.   "
52094|NCT02603692|"     In this research study the investigators want to learn more about the quality of life before,     during and after cancer treatment in patients with central nervous system brain tumors. Often     CNS tumors and cancer treatment can cause many physical and emotional problems and side     effects. Some of these problems and treatment side effects can cause a change in a patient's     qualify of life and overall well-being. Quality of life questionnaires are used to measure     well-being and ability to carry out daily activities by asking patients to answer several     questions about their physical, emotional, and social well-being.      In this research study we want to find out if patient's answers to these questions change     over the course of your treatment. We also want to see if doctors and nurses can use these     answers to the questions to help patients feel better and increase their activity during     cancer treatment.   "
52095|NCT02603679|"     The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy     using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib     and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover.     During the 24-weekly treatment period, clinical and radiological evaluations are performed     repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response     or due to toxicity. A translational subprotocol is a mandatory part of the study protocol,     except for use of PET-CT evaluations. Postoperatively, patients receive three 3-weekly     courses of chemotherapy with a combination of epirubicin and cyclophosphamide.   "
52096|NCT02603666|"     The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease     (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological     evaluation of liver biopsy if present.   "
52097|NCT02603653|"     Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease     is responsible for increased morbidity and mortality. Recent studies have pinpointed the     frequency of somatic sequelas and persistent alteration in quality of life despite the cure     of the disease. More specifically, a few studies have described persistent psychopathology,     maladaptive personality and cognitive impairments in patients with a history of Cushing's     disease. Among these, hippocampal memory deficits have been found in the majority of studies,     a finding that is consistent with the alterations described in hippocampal neurons during     chronic exposure to glucocorticoids. However, the tools currently available to assess     hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and     to analyze or may lack of diagnostic sensitivity. The investigators have recently developed     an original tool, the virtual radial task in 3D, which has shown to be reliable to detect     subtle alterations in hippocampal-dependent memory in several human diseases. The primary aim     of the study is the evaluation of persistent cognitive impairments (hippocampal memory) in     patients cured of Cushing's disease for at least one year using the virtual radial task in 3D     and to compare it with that obtained with classical cognitive tests.   "
52117|NCT02603380|"     This qualitative study aims to evaluate the usability of a smartphone application called     DelApp. The study will assess usability and acceptability of the software app by asking 40     clinicians to administer the DelApp assessment to consented patient and clinicians. Feedback     will be collected through semi-structured interviews with the clinicians. The feedback will     be used to optimise the software application in preparation for formal validations studies.   "
52255|NCT02601547|"     Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a     promising approach for detecting brain lesions in dementia, among which Alzheimer's disease     has been the most widely studied.   "
52098|NCT02603640|"     Epilepsy is a major neurological disorder, affecting of the order of 0.5 to 1% of the     population. It is a very invalidating disease, with high impact on quality of life. In a     large proportion of cases, medication cannot prevent seizures; surgical removal of the     regions responsible for seizures is then the only way to cure patients. However, results     crucially depend on the correct delineation of the epileptogenic zone.      In this context, computational modeling, under the form of a virtual brain is a powerful     tool to investigate the impact of different configurations of the sources on the measures, in     a well-controlled environment.      In this project, the simulate in a biologically realistic way MEG (Magnetoencephalography)     and EEG (Electroencephalography) fields produced by different configurations of brain     sources, which will differ in terms of spatial and dynamic characteristics will be offered to     participants. The research hypothesis is that computational and biophysical models can bring     crucial information to clinically interpret the signals measured by MEG and EEG. In     particular, the hypothesis can help to efficiently address some complementary questions faced     by epileptologists when analyzing electrophysiological data.      The strategy will be three-fold:      i) Construct a virtual brain models with both dynamic aspects (reproducing both     hyperexcitability and hypersynchronisation alterations observed in the epileptic brain) and a     realistic geometry based on actual tractography measures performed in patients ii) Explore     the parameter space though large-scale simulations of source configurations, using parallel     computing implemented on a computer cluster.      iii) Confront the results of these simulations to simultaneous recordings of EEG, MEG and     intracerebral EEG (stereotactic EEG, stereoelectroencephalography (SEEG)). The models will be     tuned on SEEG signals, and tested versus the surface signals in order to validate the ability     of the models to represent real MEG and EEG signals.      The project constitutes a translational effort from theoretical neuroscience and mathematics     towards clinical investigation. A first output of the project will be a database of     simulations, which will permit in a given situation to assess the number of configurations     that could have given rise to the observed signals in EEG, MEG and SEEG. A second - and major     - output of the project will be to give the clinician access to a software platform which     will allow for testing possible configurations of hyperexcitable regions in a user-friendly     way. Moreover, representative examples will be made available to the community through a     website, which will permit its use in future studies aimed at confronting the results of     different signal processing methods on the same 'ground truth' data.   "
52099|NCT02603627|"     This study will investigate the prevalence of chronic obstructive pulmonary disease (COPD) in     patients who are newly diagnosed with lung cancer and compare it to the prevalence of COPD in     controls recruited from a smoking cessation clinic.   "
52100|NCT02603614|"     CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover     design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate     renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled     subjects will begin with Infusion Period A where they will receive up to 7 days of     continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the Insulet     Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B where     they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of     cenderitide or placebo.   "
52101|NCT02603601|"     This randomized controlled trial is designed to test the feasibility and efficacy of a novel     10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and     psychosocial outcomes in patients who have undergone bariatric surgery.      Primary hypothesis:      Bariatric patients who have stopped losing weight (< 5 lbs weight loss in past month) 1-5     years post-surgery will be willing to participate in this 10-week intervention. The     investigators expect a high adherence rate (>70%) and no issues with meeting recruitment     goals.      Secondary hypotheses:      Patients assigned to the MBI will show greater improvement in a) weight control (defined by     differences in body weight between baseline and follow-up); b) eating behaviors (binge     eating, emotional eating); and c) psychosocial measures (quality of life, depression,     perceived stress, eating self-efficacy, coping ability) than a standard lifestyle     intervention (1 hr lifestyle counseling).      Patients assigned to the MBI intervention will show greater improvement in biomarkers of     stress and inflammation [salivary cortisol, high sensitivity C-reactive protein (hs-CRP),     interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)] as compared with a     standard lifestyle intervention.      Food-related attentional bias as measured by the food-related Stroop task will be     differentially affected among patients assigned to the MBI as compared with the intensive     lifestyle intervention and standard lifestyle intervention.   "
52102|NCT02603588|"     Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in     treatment of nasal inflammatory disease, but the mechanisms remain largely unknown.     Investigators aimed to assess the effects of SPG acupuncture for nasal ventilation function     and autonomic nervous system in health volunteers. The randomized, double-blind, controlled     clinical trial enrolled healthy volunteers.Healthy subjects were randomly assigned to either     active SPG-acupuncture group or sham-acupuncture group. All subjects were assessed for     self-reported nasal ventilation, nasal patency (nasal airway resistance (NAR) and nasal     cavity volume (NVC)), exhaled nasal nitric oxide (nNO) before and after acupuncture.     Meanwhile, in order to explore underlying mechanisms of SPG acupuncture, the changes in     neuropeptides (substance P (SP), vasoactive intestinal peptide (VIP) and neuropeptide Y     (NPY)) in nasal secretions were investigated at baseline, 30 minutes, 2 hours, and 24 hours     after acupuncture.   "
52103|NCT02603575|"     Pneumocystis Pneumonia is increasing in Immunocompromised Non-HIV Infected Patients. The     effects and safety of caspofungin and corticosteroids is not certain in this population. All     Immunocompromised Non-HIV patients with respiratory failure were randomized into caspofungin     and non-caspofungin group and corticosteroids and non-steroids group. The major outcome is 28     day mortality, the second outcome are time of respiratory rate decreases to less than 25     breath per minute, body temperature lower than 37.3℃.   "
52104|NCT02603562|"     The purpose of this study is to assess the safety and biological activity of ATYR1940 in     patients with early onset facioscapulohumeral muscular dystrophy (FSHD).   "
52105|NCT02603549|"     Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for     spontaneous intracranial hypotension, leading to positional headache patterns. Typical     magnetic resonance imaging findings include subdural fluid collections, enhancement of     pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the     brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous     cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the     investigators would like to like to assess the clinical manifestations and neuroimaging     abnormalities of SIH patients with regard to the pituitary gland. Specifically, the     investigators are looking to analyze the compression of the pituitary stalk and conduct a     systemic evaluation of pituitary function in SIH patients.   "
52155|NCT02602886|"     The purpose of this research study is to evaluate whether Exposure and Response Prevention     Therapy (ERP) can help adults with obsessive-compulsive disorder (OCD) in China following a     training of professionals and ongoing consultation.   "
59028|NCT02512900|"     To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of     MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.   "
52106|NCT02603536|"     WelTel Oak Tree is a repeated measures study that enrolled 85 HIV+ individuals from the Oak     Tree Clinic at BC Women's Hospital. Participants were be provided with a cell phone and/or     unlimited text messaging capability if they do not have it already, and for one year received     a weekly text message stating How are you. Participant problems and non-responses were be     followed up by a nurse. Data on demographics, CD4 counts, HIV viral loads, HIV medication     adherence and attendance at appointments was collected for the year prior to the intervention     and during the intervention for comparison. Data assessing quality of life was also collected     at three points during the one year study period. Cost effectiveness and cost benefit of the     intervention is being studied to assess feasibility of transferring the intervention to a     programmatically funded facet of patient care.   "
52107|NCT02603523|"     The efficacy of exercise programs to prevent falls among older people is well documented in     the literature. However, older people's adherence to these exercise programs has been     reported to be suboptimal, varying between 21% and 74%. In addition, about 45% of people aged     over 60 years do not meet the minimum recommended level of physical activity. In this     context, dance is a promising alternative to traditional exercise programs, as it can     positively influence important risk factors for falls, such as sedentary lifestyle, balance     impairments and muscle weakness. Nevertheless, a recent systematic review conducted in this     area show that the lack of randomized clinical trials as well as the low methodological     quality of existing studies do not allow to reach definitive conclusions on the real effects     of dance on risk factors for falls. A type of dance that is becoming popular among the older     population in Brazil is the Senior Dance. Senior Dance classes consist of different     choreographies, which include rhythmic and simple movements with rhythmic folk songs. The     concentration required to learn the choreographies challenges balance, motor coordination and     cognitive function. Thus the present study is a randomized clinical trial aiming to     investigate the Senior Dance effect on balance, mobility and cognitive function, compared     with a control group, among older people living in the community. A total of 82 subjects will     be randomly allocated into two groups. The intervention group will participate in a 12-week,     twice-weekly group-based program of Senior Dance, while the control will be encouraged to     maintain their current routine activities. Outcomes measures (balance, mobility and cognitive     function) will be evaluated before and after the intervention by an assessor blinded to group     allocation. The results of this study will assist health practitioners when prescribing     intervention for the older population.   "
53725|NCT02582359|"     This research study is evaluating drugs called Millennium 9708 (referred to as MLN9708) in     combination with standard therapy for acute myeloid leukemia (AML) consisting of daunorubicin     and cytarabine as a possible treatment for the patient AML.   "
52108|NCT02603510|"     Primary Objective:        -  Assess the safety of SAR342434 and Humalog when used in external pumps.      Secondary Objectives:        -  Intervals for infusion set changes.        -  Incidence of insulin pump alarms for infusion set occlusion.        -  Patient observation of infusion set occlusion.        -  Adverse events including bruising at the infusion site and injection site reactions.   "
52109|NCT02603497|"     The objective of this study is to compare the pharmacokinetics of ASP015K in patients with     impaired renal function and subjects with normal renal function.   "
52110|NCT02603471|"     The proposed study, for HIV positive alcohol dependent adults currently taking naltrexone, is     a pilot randomized controlled trial (RCT) examining the outcomes of a 12-week behavioral     support program delivered via text-messaging.      It is expected that the text messaging intervention will reduce alcohol use and HIV-risk     behaviors. The investigators also hypothesize that the intervention will improve adherence to     HIV treatment and naltrexone.      To test the effects of the intervention on these target outcomes, 25 participants receiving     the text messaging intervention will be compared to 25 participants receiving an     informational pamphlet. The pamphlet will contain information about the importance of HIV     treatment adherence, reducing HIV risk behaviors, and health consequences associated with     alcohol use.      By providing support to maximize HIV treatment regimen and naltrexone adherence, coupled with     coping skills to promote abstinence from alcohol, the text messaging intervention may provide     a promising, cost-effective, and easily deployable behavioral support program for alcohol     users who are HIV-infected.   "
52111|NCT02603458|"     This study seeks to examine the effectiveness of NRX-1074 in the treatment of negative     symptoms and cognition in schizophrenia compared to other agents at the glycine site which     have demonstrated inconsistent results for negative symptoms. In addition to testing     efficacy, we will examine the time course of response of symptoms as well as any effects on     memory consolidation.   "
52112|NCT02603445|"     This is a phase Ib multi-center, open-label study: escalation part followed by expansion     part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety     and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.      Approximately 65 patients are to be enrolled.      The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab     abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic     regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib.     In addition Bayesian regression models will be used to estimate the dose-exposure     relationships for both BCL201 and idelalisib in order to guide the escalation steps. A     Bayesian method for the expansion part will be used for the primary activity objective.      The study data will be analyzed and reported based on all patients' data of the escalation     and expansion part.   "
52113|NCT02603432|"     The main purpose of this study is to compare maintenance treatment with avelumab plus best     supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in     patients with locally advanced or metastatic urothelial cancer that did not worsen during or     following completion of first-line chemotherapy.   "
52114|NCT02603419|"     This is a Phase 1b dose-finding study to evaluate the pharmacokinetics, pharmacodynamics, and     preliminary antitumor activity of avelumab (MSB00100718C) in adult patients with relapsed or     refractory classical Hodgkin's Lymphoma (cHL). Patients enrolled in this study are required     to have failed a prior course of high dose chemotherapy as a part of a first-line salvage     chemotherapy regimen for cHL. The primary purpose of this study is to assess the     pharmacokinetics, biological activity and early signs of efficacy of various avelumab dosing     regimens in patients with cHL.   "
52115|NCT02603406|"     Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in     patients with cerebral perfusion deficits (NIMBUS trial)   "
52116|NCT02603393|"     This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18     µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate     to severe COPD   "
52725|NCT02595398|"     The study is designed to evaluate the safety and efficacy of suprachoroidally administered     triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with     non-infectious uveitis.   "
52118|NCT02603367|"     This pilot clinical trial studies the COMFORT (C-Communication, O-Orientation and     opportunity, M-Mindful presence, F-Family, O-Openings, R-Relating, and T-Team) caregiver     intervention in improving communication and reducing distress in caregivers of patients with     lung cancer. Caregivers of patients with cancer may experience stress and anxiety due to     difficulty communicating with family, friends, and healthcare providers, or feeling unable to     communicate openly. A communication intervention that improves the caregiver's ability to     communicate with patients and healthcare providers may help reduce caregivers' psychological     distress and improve the health outcomes of patients.   "
52119|NCT02603354|"     The purpose of this clinical study was to evaluate, the effectiveness and sensitivity     post-treatment of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated     bleaching agent, the impact of shorter interval times on tooth sensitivity and to compare the     efficacy with 2 different application protocols. This is a clinical randomized double-blind     split-mouth study. 31 patients were treated with: one upper hemi arcade with one application     of 36 minutes and the other hemi arcade with 3 applications of 12 minutes each with a 6%     hydrogen peroxide. Two sessions were appointed with 48h of intervals between them. Tooth     colour was registered by VITA Classical amd VITA Bleach guide by two blinded assessors in the     beginning, immediately after each session. Tooth colour variation and sensitivity were     compared between both application protocols   "
52120|NCT02603341|"     A pragmatic randomized clinical trial of patients with locally advanced breast cancer     randomized to either proton or photon therapy and followed longitudinally for cardiovascular     morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality     of life is the outcome measure for the estimated primary completion date of November, 2020,     www.radcomp.org.   "
54299|NCT02574858|"     The purpose of this study is to evaluate the safety of orally administered QRH-882260, a     topically administered Cy5-labeled heptapeptide specific for epithelial growth factor     receptor (EGFR).   "
52121|NCT02603328|"     This phase I/II randomized, placebo-controlled, double-blinded, single-site clinical trial is     designed to investigate the effect of a prolonged course of atorvastatin versus placebo on     CCM lesional iron deposition assessed by validated quantitative susceptibility mapping (QSM)     MRI studies in patients who suffered a symptomatic bleed within the preceding one year.   "
52122|NCT02603315|"     The purpose of this study is to To assess the correlation between the predictive factor of     vascularity (CD74) in malignant pleural mesothelioma and treatment results (response rate,     and overall survival) .   "
52123|NCT02603302|"     This is a one arm study where patients with locally advanced rectal cancer will receive     neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to     59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal     excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete     response).   "
52124|NCT02603289|"     The purpose of this study is to demonstrate that changing aligners weekly provides similar     results to changing aligners every two weeks.   "
52125|NCT02603276|"     A large body of evidence confirm the cholesterol lowering effect of phytosterols and red     yeast rice. Because their mechanisms of action mime the ones of chemical statins and     cholesterol absorption inhibitors, it is plausible that their association will provide a more     relevant (and safe) LDL cholesterolemia reduction.   "
52126|NCT02603263|"     Encouraging individuals to eat fruit and vegetables is difficult. However, recent evidence     suggests that using social-based information might help. For instance, it has been shown that     if people think that others are eating lots of fruit and vegetables, that they will consume     more food to match the 'norm'.The purpose of this study was to determine whether social norm     messages could be used to enhance vegetable purchases in workplace restaurants, in an     observational study.   "
52127|NCT02603250|"     The purpose of this study is to evaluate the use of a noninvasive Hb device (Pronto® with     DCI-mini™ sensors) as an accurate method for measuring Hb levels among children between 6 and     59 months against the standard reference hematology analyzer. The secondary purpose is to     evaluate the accuracy of two HemoCue® Hb 201+ capillary blood collection methods against the     standard reference hematology analyzer.      The study hypothesizes that the Pronto® with DCI-mini™ sensor will approximate Hb values     within ±1.0 g/dL and secondly, it will correctly classify participants as anemic or not     anemic with less than 31% disagreement when compared to the standard reference hematology     analyzer among children 6 to 59 months of age. Additionally, the two different HemoCue® Hb     201+ capillary blood collection methodologies will both approximate Hb values within ±1.0     g/dL and secondly, it will correctly classify participants as anemic or not anemic with less     than 35% disagreement when compared to the standard reference hematology analyzer among     children 6 to 59 months of age.   "
52128|NCT02603237|"     The study will compare plasma and urine post-prandial metabolomics after fat and glucose oral     load according to lifestyle factors.   "
52129|NCT02603224|"     The primary objective of this study is to evaluate the safety and tolerability of the     investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the     activity of a molecule called miR-29 that decreases the expression of collagen and other     proteins that are involved in scar formation. MRG-201 is being studied to determine if it can     limit the formation of fibrous scar tissue in certain diseases.      MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a     short skin incision. Volunteers may receive one or several doses of MRG-201, and will be     monitored for local reactions in the skin, signs or symptoms of adverse effects on the body,     and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to     study how cells in the skin respond when exposed to MRG-201.   "
52130|NCT02603211|"     The aim of this study is to see how well a tactile imaging sensor will detect for breast     masses compared to traditional mammography and/or ultrasound. This device may allow a simple,     convenient method to screen for breast tumors. This data will be used to check the     feasibility of using the device to detect breast tumors.   "
52172|NCT02602652|"     The objective of this study is to measured the Geometric mean titer (GMT) of Japanese     Encephalitis neutralizing antibody and proportion of seroprotection among the children who     received a booster dose of JE-CV after the first dose of SA14-14-2 vaccine.   "
83680|NCT02190669|"     This proposal seeks to gather continuous blood glucose and physical activity data from     individuals with and without diabetes.   "
52131|NCT02603198|"     Dental treatments, particularly third molars extraction, can become extremely uncomfortable     and painful. They are associated to anxiety, fear and many other unpleasant sensations.     During surgery, patients can present cardiorespiratory repercussions of these sensations.     This fact generally justifies the employment of methods of monitoring and appliance of safer     therapeutic alternatives. Local anesthetics are the most frequently drugs used in dentistry.     Vasoconstrictors, particularly epinephrine, are important components of anesthetic solutions     to increased time for anesthetic absorption and consequently increasing the duration of     anesthesia. The use of smaller amounts of anesthetic solution can reduce the risk of systemic     toxicity, however decrease the total surgical time. It is well known that the amount of     epinephrine injected into patients during anesthetic procedures can produce adverse     hemodynamic effects. Levonordefrin was adding to dental cartridges promising to reduce     cardiac stimulation due it less β activity, and maintain the same clinical and systemic     effects. But some studies for maxillary or intraosseous infiltrations showed no difference in     heart rate and any anesthetic success over epinephrine. Thus, this study aims to compare the     clinical efficacy and safety of anesthetic mepivacaine 2% with epinephrine 1:100,000 or     1:20,000 levonordefrin employing a clinical trial model of third molars extractions in     healthy adults.   "
52132|NCT02603185|"     This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential     ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of     ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3,     respectively. Food effect following a single oral dose will be evaluated in Part 2.   "
52145|NCT02603016|"     This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast     carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE     compound,120 patients will recrive Maitake mushroom extract compound,120 patients will     recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of     Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma   "
52233|NCT02601833|"     The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF)     for treatment of cavities in baby teeth. The investigators will compare the effectiveness of     stopping the cavity, cost of the treatments and the opinions of the families and the dental     providers.   "
52133|NCT02603172|"     GSK3039294 has been developed in order to offer an orally available alternative to parenteral     CPHPC (GSK2315698 [metabolite of GSK3039294]) for plasma serum amyloid P component (SAP)     depletion prior to use of anti SAP monoclonal antibody (mAb) in the treatment of systemic     amyloidosis. This phase 1 study is intended to study safety, tolerability and pharmacokinetic     (PK) profile of GSK3039294 in humans. This study consists of three parts. Part A will     evaluate safety and tolerability of single doses of GSK3039294 in healthy subjects, Part B     will evaluate safety and tolerability of repeat doses of GSK3039294 in healthy subjects, and     Part C will evaluate safety and tolerability of repeat doses of GSK3039294 in subjects with     systemic amyloidosis. Part A is a single dose, open label, dose escalation study. Two cohorts     of subjects will be enrolled to provide data from 6 subjects per cohort and up to 4 different     doses (2 dose levels per cohort) of GSK3039294 will be tested. For Cohorts 1 and 2, each     subject may take part in two dosing periods. Part B is repeat dose, open label, dose     escalation study. Sufficient number of subjects will be enrolled in Cohort 3a to ensure 6     completers (Cohort 3b will be conducted if required) and GSK3039294 will be administered     repeatedly for a total of 21 days. Each subject will take part in a single study period. In     Part C a single dose level of GSK3039294 will be tested for 21 days repeat dose, in 12     subjects with systemic amyloidosis. Each subject will take part in a single study period. The     total duration for Part A is approximately 8 weeks, Part B is approximately 8-9 weeks, and     Part C is approximately 13 weeks.   "
52134|NCT02603159|"     Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the     standard in Western countries in esophagus cancer.But in China because of its toxic reaction,     most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the     chemotherapy of esophageal cancer.      The purpose of this experiment was to study the different cycle on capecitabine with     chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years     study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival     and the secondary endpoints include progression-free survival, response rate,pathologic     complete response rate and adverse events.   "
52135|NCT02603146|"     The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective     for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have     elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP).      The following recruitment strategies will be employed towards identifying healthy subjects     with elevated anti-cyclic citrullinated peptide 3 (anti-CCP3) levels:      -Pre-screening:        -  first degree relatives of patients with RA;        -  subjects at health-fairs; and        -  identification of subjects with elevated anti-CCP3 levels in the absence of inflammatory          arthritis in rheumatology clinics.   "
52136|NCT02603133|"     Resilience means a healthcare provider's ability to cope, recover, and learn from stressful     events, as well as their access to resources that promote health and well-being. Neonatal     intensive care unit (NICU) health professionals' need to have particularly good resilience,     because their work is extremely stressful and their patients, fragile preterm infants,     require their undivided attention. The investigators propose a feasible and engaging     intervention to enhance resilience among NICU health professionals promoting their ability to     provide safe care.   "
52137|NCT02603120|"     This study will evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and     abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC     as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected adults.   "
52138|NCT02603107|"     This study will evaluate the safety and efficacy of switching to a fixed dose combination     (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a     regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in     HIV-1 infected adults who are virologically suppressed.   "
86821|NCT02149641|"     In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2)     subjective xerostomia at 1 year.   "
52139|NCT02603094|"     Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to     minimize the risk of regurgitation, vomiting and pulmonary aspiration during general     anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of     this study and can be investigated in children undergoing elective procedures in general     anaesthesia and intubation without inconvenience or additional invasive procedure and hence     without additional risk      Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication     before anaesthesia induction than in those that drink until 2 hours before anaesthesia     induction   "
52140|NCT02603081|"     This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to     placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's     disease.   "
52141|NCT02603068|"     This multicenter, randomized, open-label study will assess the safety and efficacy of oral     treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary     fibrosis.   "
52142|NCT02603055|"     Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly     infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to     15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E     vaccine.      This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial.     This study will determine the safety and immunogenicity of the investigational recombinant     hepatitis E vaccine in healthy adults between 16 and 65 years.   "
52143|NCT02603042|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of     Hypophosphatasia disease from plasma   "
52144|NCT02603029|"     Objective of the study is to determine the influence of the cream with Silver fir wood (Abies     alba) extract (Belinal) on the skin parameters and functions in comparison to the placebo     cream. 10 healthy female subjects will use the test cream on one half and placebo cream on     the other half of the face and of the gluteal part twice a day for 12 weeks. Various face     skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12     weeks of the cream use. To evaluate the photoprotective potential of Belinal the minimal     erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the cream     use at the gluteal area.   "
52146|NCT02603003|"     Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor     cells(CTCs) play a key role in the process of distant metastasis. The investigators' study     will elaborate the clinical significance of CTCs intervented by Traditional Chinese     Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and     recurrence, individual treatment and prognosis and so on, in order to provide a new direction     for the treatment of lung cancer.   "
52147|NCT02602990|"     A non-interventional multicentric study for patients with a cerebral AVM for which     endovascular treatment is indicated.   "
52148|NCT02602977|"     In a wide range of auto-inflammatory and infectious diseases attenuation of the immune     response could be beneficial. Remote ischemic preconditioning (RIPC) has been identified as a     means of protecting patients undergoing cardiac surgery from perioperative myocardial     ischemic damage. This protection can be divided in a `first window of protection` directly     after preconditioning and a `second window` that protects patients 12-48 hour after     preconditioning. Repeated RIPC might have additional value, possibly by combining beneficial     effects of the first and second windows of protection. The mechanisms behind these effects     are under investigation, but attenuation of the inflammatory response is a major candidate.     However, this has not yet been demonstrated in the setting of systemic inflammation in humans     in vivo. This study aims to investigate the effects of (repeated) ischemic preconditioning on     inflammation during human endotoxemia.   "
52149|NCT02602964|"     Live kidney transplantation is first choice for patients with end-stage kidney disease.     Therefore, the safety and well-being of kidneys donors are highly important objectives in     live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and     therefore also concomitant use of opioids.   "
52150|NCT02602951|"     The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the     vascular anatomy. These sequences, widely used in clinical routine have shown their utility,     in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences     allow to quantify arterial parameters such as the speed of the circulating flow. By allowing     an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR     sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in     term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection     of vascular lesion and complete the exploration of the cervico-encephalic vascular     pathologies by providing hemodynamical measures not yet accessible in clinical settings.      In this context, the aim of the study is to evaluate the feasibility and the clinical     usefulness of this 4D Flow technique to image brain vascular disorders including steno     occlusive disorders. The evaluation will include several steps: 1/ optimization of     acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for     the post-processing 3/ feasibility for imaging of brain vascular disorders.   "
52151|NCT02602938|"     The purpose of this study is to determine whether Aspirin could affect the number and subtype     of circulating tumor cells of metastatic breast cancer and colorectal cancer.   "
52152|NCT02602925|"     Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics.      Objective To investigate whether the dose of biologics can be reduced in patients with     psoriasis with stable disease.      Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with     cost-effectiveness analysis.      Study population: Patients with disease remission using normal dose of biologics.      Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2)     normal dose.      Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary     outcomes are: health-related quality of life (HRQoL), number and time to disease flares,     costs, health status, anti-drug antibody formation and serious adverse events   "
52153|NCT02602912|"     The main purpose of the study is to assess the feasibility and clinical performance of     impedance based tissue identification in various spine structures.   "
52154|NCT02602899|"     Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation     to patients with refractory epilepsy.   "
52156|NCT02602873|"     Tacrolimus is recommended to be the first line therapeutic medication within the several     immunosuppressive agents when treating refractory pediatric nephrotic syndrome, because of     its definite efficacy and low toxicity. But there are still some key problems which hinder     the using of tacrolimus in clinic, such as its narrow therapeutic widow, great individual     difference of pharmacokinetics. Routine therapeutic drug monitoring(TDM) is needed in     practice. But the disadvantage of TDM is hysteresis, which could lead to treatment failure or     toxicity. To find out the reasons of great pharmacokinetic difference between patients and     find out the individual proper dosage before administration are important for the clinical     using of tacrolimus.      It is hot in research of tacrolimus in organ transplant field, such as the association     between gene polymorphisms of cytochrome P-450 3A4, 3A5 and multiple drug resistant     gene(MDR1) and concentration of tacrolimus. However, there is few study about     pharmacogenomics and metabonomics of tacrolimus in patients of nephrotic syndrome.      The aim is to study the relationships between pharmacogenomics, metabonomics of tacrolimus     and its efficacy, toxicity and blood concentration in patients of nephrotic syndrome, to find     out the exact dosage before administration, to provide reference to individual drug     administration.   "
52157|NCT02602860|"     This study will estimate how fast two antiepileptic drugs (Levetiracetam and Brivaracetam)     enter the human brain. Brain imaging will be used to measure how quickly the radioactive     probe [11C]UCB-J exits the brain when Levetiracetam or Brivaracetam are given. This will be     used to estimate how fast the antiepileptic drugs enter the brain.   "
52158|NCT02602847|"     The aim of this study is to validate in the context of liver transplantation, the interest of     the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver     biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver     through several groups of patients at transplantation (on graft and native liver explant) and     after transplantation.   "
55672|NCT02556931|"     To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell     transplant in certain malignancies that are considered difficult to engraft.   "
52159|NCT02602834|"     High intensity Interval training (HIT) has repeatedly been documented to have superior     positive effects on oxygen uptake and general physical health compared to continuous moderate     exercise in healthy individuals and patients with heart disease. Recently, the same effect     has been shown in heart transplanted recipients. Which mechanisms that explains this     difference is uncertain; the effect can be due to changes in the heart or changes in the     peripheral tissue and muscles. To explore these mechanisms the investigators will in this     study compare two different exercise modalities, and explore how different biomarkers change     in blood, related to exercise.   "
52160|NCT02602808|"     It is important to identify patients with acute pancreatitis who are at risk for developing     persistent organ failure early in the course of disease. The investigators evaluated whether     peripheral blood non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), could     serve as a good marker for detection of acute pancreatitis with persistent organ failure at     early phase.   "
52161|NCT02602795|"     Before starting treatment with XR-NTX, a medication that blocks the positive effects of     opioids and helps people stay off opioids, individuals who are dependent on opioids first     have to endure a difficult withdrawal process. This study aims to develop and test an     intervention to help people who are opioid dependent successfully complete that transition;     the investigators will also develop and test a comparison condition aimed at reducing HIV     risk behavior.   "
52162|NCT02602782|"     The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring     System and validate the accuracy of these measurements against existing gold standards, and     to track and analyze changes in these physiologic data streams to identify clinical     signatures that may enable earlier diagnosis and intervention of critical conditions.   "
52163|NCT02602769|"     Rapid onset Obesity, Hypoventilation, Hypothalamic dysfunction and Autonomic Dysregulation     (ROHHAD) is a syndrome named in 2007. The hallmark of the syndrome is the rapid onset obesity     and dysregulation of central ventilation. There is little information about the metabolic     changes that lead to the rapid onset obesity in these children. The investigators would like     to study the metabolic phenotype of these children to understand the disturbances in energy     balance that lead to the rapid onset obesity.   "
52164|NCT02602756|"     Ocular melanomas have been treated for a long time by enucleation, with an unfavorable major     impact on the patient's quality of life, social life, self-image, how they feel about others     and about living with this disability. As a matter of fact, classical radiation therapy by     photons is not accurate enough to deliver a sufficiently high dose to eradicate a melanoma     without causing irreversible ocular brain complications since these tumors are  relatively     radio resistant . The possibility of delivering high doses due to the precision of protons     (Bragg peak) has allowed to overcome this limitation. The conservative uveal melanoma     treatment has become a standard after the Collaborative Ocular Melanoma Study (COMS)     indicating an equivalent rate of metastases and a non-impaired survival rate with a     conservative treatment when compared to immediate enucleation. The quality of life benefits     due to a conservative treatment has been demonstrated. Protontherapy dose has been defined in     an empirical manner, it is probably excessive even if it applies to radio-resistant tumors.     In France, radiotherapy by protons for choroidal melanomas delivers a dose of 60 Gy cobalt     equivalent (that is 52 measured Gy, or  Physical dose) in 4 fractions and 4 days.      Referential treatment of ocular melanomas (other than conjunctiva) indicates proton-therapy     for T1, T2, T3 < 40% of ocular volume, and T4 only if extra scleral extension ≤ 2mm. However,     there is an enucleation indication for T3 > 40% of ocular volume and T4.      Our purpose is to override this relative contraindication, choroidal melanoma volume ≥ 40% of     ocular volume. As a matter of fact, the investigators observe an increasing demand from     ophthalmologists and patients for not performing primary enucleation. Also, during the last     five years treatment of complications have improved and a less  hard  hypo fractionation     (6.5 Gy per fraction) has equivalent local control results as for  hard  fractionation (13     Gy per fraction).   "
52170|NCT02602678|"     Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway     inflammation increases the respiratory system resistances and dynamic hyperinflation. This     leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease     patients as in neonates, prone position (PP) improves lung function and decreases the end     expiratory lung volume. The investigators hypothesized that in infants with severe     bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi)     and the work of breathing (WOB). The investigator designed a prospective randomized crossover     study with 16 infants younger than six months who need ventilatory support by nasal     continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of     breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure     probe in prone and supine position.   "
52165|NCT02602743|"     Ketamine and propofol have been used most frequently agents and remifentanil is used with     increasing frequency in recent years. Investigators will compare ketamine-propofol and     ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in     pediatric colonoscopy patients. Our study is a prospective, randomized comparison of     ketamine-propofol and remifentanyl-propofol for sedation in pediatric patients during     elective colonoscopy. ASA I-II, 2-16 years old, seventy children will be included in the     study after ethics committee approval and written informed consent from the parents. Children     with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will be excluded from     the study. Group I (RK); 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered     for induction in 1 minute.Then 0,1 µg/kg/h remifentanyl infusion will be started.      Group II (PK); 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and     then 1 mg/kg/h propofol infusion will be started. In case of movement, crying, heart rate and     systolic blood pressure more than 20% increase from baseline; 0.05 to 0.1 mg / kg of     remifentanil will be administered in group I, 0.5-1 mg / kg will be administered propofol in     group II. Not enough that case 0.5-1 mg / kg of ketamine will be applied.      The anesthesiologist will continue monitoring after completion of colonoscopy until recovery     of full consciousness. A Steward recovery score of 7 will be defined as the end of the     recovery time.   "
52166|NCT02602730|"     This project developed and evaluated an Internet-based interactive program with digital     coaching designed to assist two groups of smokers in quitting smoking: (1) pregnant smokers     and (2) general-population smokers (i.e., men and non-pregnant women). Program content was     based on the U.S. Department of Health and Human Services Clinical Practice Guidelines,     Treating Tobacco Use and Dependence: 2008 Update (Fiore et al., 2008) and input from     project consultants.   "
52178|NCT02602574|"     Post endoscopic pancreatitis (PEP) has different initial immunologic response to primary     injury compared to acute pancreatitis of other etiology (non-PEP AP).      The purpose of this study is to compare initial immunologic response, 24 h after primary     injury, in patients with PEP and patients with acute pancreatitis of other etiology.   "
52179|NCT02602561|"     The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL     injury occurs participation in physical activity is compromised. Reconstructive surgery is     often necessary to repair the damage which is then followed by a regimen of physical therapy     in order to regain full activity. Nutritional intervention after the surgery could help the     patient maintain muscle mass during recovery, thus allowing for a quicker return to normal     activity.   "
52180|NCT02602548|"     This study will describe the time point at which a positive culture from a patient who has     undergone shoulder surgery should be treated as an infection versus a false positive result     that should be disregarded. Intraoperative biopsies will be taken and cultured from 50     subjects who have undergone an open surgical procedure and 50 from subjects undergoing an     arthroscopic procedure.   "
52167|NCT02602717|"     Cytological examination of punctured lymph nodes is the gold standard for confirming     metastatic lymph node spread of differentiated thyroid cancers. In order to increase the     diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels     of the aspirate could be included. Although this technique has been well proven, many     uncertainties remain, especially with regards to a pathological cut-off value and its     clinical utility when the thyroid is still intact. This uncertainty is mainly due to     discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology,     and their final histopathological analyses.      To eliminate this uncertainty, cyto-punction will be performed intra-operatively after     localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The     thyroid gland might be present or absent (already operated) depending on the case. Finally,     the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In     order to determine whether the Tg values are appropriate in cases where the thyroid is     intact, a control group has been included (First operation for thyroid cancer or benign     pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection     in patients for whom it is not indicated, only lymph nodes found along the incision path for     neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed     and excised.   "
52168|NCT02602704|"     -  The purpose of this study is to study the effectiveness of bazedoxifene in preventing          loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in          postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs.        -  This is a randomized, controlled, open-label extension study for 48 or 56 weeks. At          study entry, all patients will receive elemental calcium (1200 mg daily) and vitamin D          (800 IU daily) and will be randomized by blocks of two to receive either bazedoxifene          (20 mg/day) or none.   "
52169|NCT02602691|"     Transplant rejection is one of the most important complications of heart transplantation and     requires a specific monitoring, including regular and invasive endomyocardial biopsies.      The average hospital cost of a biopsy has been estimated at 3 297 dollars in United States.     In France, the reimbursement rates by the Health Insurance for the corresponding stays vary     from 682 to 25 865 euros, according to the finding of a rejection and its severity.      AlloMap® is a non-invasive blood test that can identify patients with low probability of     moderate to severe acute cell transplant rejection. The non-inferiority of the use of the     AlloMap® test has been demonstrated in comparison of the usual care in terms of diagnosis of     acute cellular rejection in a randomized study conducted in the United States. Following this     study, the ISHLT (International Society of Heart and Lung Transplantation) made     recommendations advocating its use for these patients between 6 months and 5 years after     heart transplantation. This new test could be an alternative to systematic biopsies usually     performed to patients whose allograft function is stable, but it is very expensive since the     analysis of a blood sample cost 2 000 euros pre-tax in France. This cost has to be compared     with the current patient care. By replacing biopsies performed systematically, the test     should reduce the costs of full and day hospitalizations for the realization of biopsies but     also the costs associated with their possible complications. In addition, it can be expected     that its use provides a benefit to the patient in terms of quality of life. Indeed, the     achievement of a biopsy may cause significant stress and anxiety for the patient, due to     discomfort, pain and potential complications that may be severe.      To this day, no medico-economic assessment has been conducted to prove the interest of the     use of AlloMap® compared to systematic realization of endomyocardial biopsies. The purpose of     the CUPIDON study is to assess the effectiveness of the use of the AlloMap® test for     monitoring heart transplant patients in the context of usual care and in accordance with     international recommendations. AlloMap® will be used and compared to the current surveillance     strategy by endomyocardial biopsies from 6 months to 36 months after heart transplantation.     The investigators hypothesize that the use of this test for the diagnosis of acute cellular     transplant rejection would avoid the costs of a large number of biopsies, while increasing     the quality of life of patients related to their health.   "
52171|NCT02602665|"     This is a single center, randomized, controlled trial in which tunneled central line     catheters will be placed in two distinct, select positions. The catheter tip position will     then be followed up prospectively after placement to determine whether there is any     malpositioning of the tip and if one placement is better than the other.   "
52173|NCT02602639|"     Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity     (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs     (100%) when compared to the general population. It is important to identify the modes and     intensities of exercise most likely to generate a reduction in these inactivity-related     diseases in this population.      Therefore, the main purpose of this pilot research project is to implement and test a form of     a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical     stimulation).   "
52174|NCT02602626|"     The purpose of this study is to determine if women would find it acceptable to receive the     HPV vaccine postpartum at the pediatrician's office at the time of their child's two-month     well- child visit when offered during the third trimester of pregnancy.   "
52175|NCT02602613|"     A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its     ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a     minimally invasive trans-catheter method.   "
52176|NCT02602600|"     The aim of the present study is to evaluate the effect of treatment with Liraglutide on the     coronary microvasculature and angina symptoms, in overweight patients with microvascular     dysfunction and angina pectoris but no coronary artery stenosis.   "
52177|NCT02602587|"     Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is     down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is     accumulated in cancerous conditions and virtually absent of normal tissues. This study will     try to determine modulations of these oxysterols and protein involved in their metabolism     between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for     evaluation of these markers as companion biomarkers for Dendrogenin A treatment.   "
52181|NCT02602535|"     The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery     Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic     pain to prescription opioid misuse and addiction. The investigators plan to conduct a full     scale clinical trial to determine whether MORE (relative to a support group control     condition) can reduce symptoms of chronic pain and opioid misuse among patients who are     receiving pain management in primary care via long-term opioid analgesic therapy.   "
52182|NCT02602522|"     This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia     Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary     dysmenorrhea.   "
52183|NCT02602509|"     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium     tuberculosis of celecoxib in combination with established drugs used to treat tuberculosis     (TB). Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in     healthy volunteers following administration of the study drugs alone and in combination.   "
52184|NCT02602496|"     This study evaluates the impact of increased intake of fruits and vegetables and whole grains     on markers of inflammation and gut microbial composition. The treatment groups are 3 servings     of whole grain per day; 5 servings of fruits and vegetables per day; a combined 3 servings of     whole grain per day and 5 servings of fruits and vegetables per day; and a control (3     servings of refined grains per day provided).   "
52185|NCT02602483|"     The objetive of this study is to explore the efficacy and safety of a triple combination of     ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients   "
52186|NCT02602470|"     To survey patients with rosacea about their rosacea treatment preferences as well as to     assess potential drivers of rosacea treatment satisfaction.   "
52187|NCT02602457|"     Atrial fibrillation is the most common heart rhythm disorder. The management of atrial     fibrillation is of great importance. Despite the presence of exercise intolerance, weight     gain, and an associated decline in overall health and well-being in patients living with     atrial fibrillation, recommended standard care does not currently include the prescription of     exercise to address these significant health issues. Exercise training is a recognized form     of treatment of persons with heart disease. An exercise program such as high-intensity     interval training when compared to moderate-intensity continuous exercise training may     provide a stronger training stimulus for exercise and clinical outcomes; may be more     efficient and motivating; and, may help to improve adherence to exercise training in     persistent or permanent atrial fibrillation patients. This has been shown in patients with     coronary artery disease and heart failure.      The primary objectives of this prospective study are to examine the impact of high-intensity     interval training compared to moderate-intensity continuous exercise training in adults with     persistent or permanent atrial fibrillation on exercise capacity and quality of life.   "
52188|NCT02602444|"     The purpose of the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics     (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation     myocardial infarction (NSTEMI) patients designated to invasive strategy. Data regarding     comparison of PK and antiplatelet action of ticagrelor in STEMI and NSTEMI are sparse.     Recommended dosing regimens of ticagrelor are identical for both STEMI and NSTEMI, although     it is not known whether PK and PD features of ticagrelor are uniform in these patients.   "
52189|NCT02602431|"     Third molars extraction is a surgery frequently performed in dentistry. It is generally     associated to a great postoperative distress rendered by pain, swelling and trismus, caused     by surgical trauma inflammation. Several methods have been proposed to prevent these     complications and to increase tissue repair quality. The use of low level laser therapy     (LLLT) has been reported in dentistry since 1970. A large number of studies have reported the     benefits of LLLT without collateral damage, positive effect as an anti-inflammatory agent and     benefits in accelerating wound repair. However, some clinical applications strategies have     been contradictories in everyday practice with results not always equivalent.      Objective: To verify if a single LLLT intra or extra oral application, singly, are analogous     in their effects in controlling postoperative edema, trismus, pain and wound repair in third     molar surgery.   "
52252|NCT02601586|"     This study will be conducted in three parallel groups receiving oxycodone, levodopa or     placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian     treatment. As this study focuses on chronic central neuropathic pain caused by PD, the     effects of study treatments will be evaluated after a 10-week treatment period   "
52190|NCT02602418|"     Despite potent combination antiretroviral therapy, cognitive (memory and concentration)     problems continue to occur in up to 50% of HIV-infected individuals, especially in older     infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no     effective treatments are available to these individuals with cognitive problems, conservative     estimates indicate that the cost of care for these patients could double in the next two     decades. To address this urgent problem, this study will use a comprehensive approach     (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel     computer-based training program would improve the brain function, especially working memory     and attention, in HIV-infected and infected individuals.   "
52191|NCT02602405|"     In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain     permanent functional impairment, 1.200 receive disability pension, and approximately 2.500     die because of their injuries. Mortality is the most common variable measuring trauma     outcome. However, measuring only trauma mortality may be looking merely at the tip of the     iceberg. For every trauma death, there are ten-folds suffering long term functional     impairment. Mortality is therefore a too crude variable to describe the impact of injuries -     both for the individual trauma patient and for society as a whole. There is a need for     variables describing long-term outcomes on a functional level. The aim of this study is to     use the rate of return to work and education as an alternative outcome measure. The ability     of returning to work after injury is a central indicator of individual functional outcome,     combining both physical and mental skills in performing complex and compound tasks. Previous     studies on return to work after injury are limited by a combination of short follow-up times,     the use of patient reported outcomes and having mainly been focusing on only severely injured     patients (ISS > 15). This a population-based study including all patients in working age (16     - 65 years) received by a trauma team in any of the eight hospitals within the region of     Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already collected     trauma registry data will be linked with national register data on sickness and disability     benefits, employment and education.   "
61928|NCT02475018|"     The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in     reducing the serum cholesterol in human with hypercholesterolemia.   "
52192|NCT02602392|"     The potential benefits of this research to public health include improved understanding of     cultural factors in pediatric asthma self-management, improved self-management skills for     children, and better asthma management skills for their parents. This could result in eased     suffering and improved quality of life for millions of children and their families, and also     reduce the economic burden borne by society in the forms of medical expenditures and lost     productivity.   "
52193|NCT02602379|"     Contrary to immobility and, to a lesser extent, to the hypnosis/unconsciousness component     of general anaesthesia, the monitoring of analgesia remains largely elusive, evaluated     mainly through poorly sensitive and potentially undesirable changes in patients' vital signs.     This has led the industry to pursue the development of various devices and indices based on     other physiological parameters such as heart rate variability (HRV), electroencephalogram     (EEG), skin conductance, to name only a few. To the best of the knowledge, none of these     parameters on its own has shown sufficient capacity in detecting different degrees of     pain/analgesia balance to gain wide clinical use.      The purpose of this prospective observational study is to evaluate the response of a     single-parameter index (the Analgesia Nociception Index [ANI]) and a multi-parameter index     (the Nociception Level [NoL] Index) when patients under combined general anaesthesia/epidural     anaesthesia for laparotomies are subjected to a standardized painful stimulus (a tetanic     stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds) at different doses of     remifentanil infusion at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min; 0,1 mcg/kg/min;     0,15 mcg/kg/min). With the painful stimulus held constant but the analgesia provided     gradually increased, it is expected to characterize the response of these two indices to     different levels of nociception/anti-nociception balance.   "
52194|NCT02602366|"     The purpose of The Quatro Study is to assess the acceptability, preferences, user experience     and effect on sexual behavior of four different vaginal microbicide or multi-purpose     technology (MPT) delivery forms, using placebo products in 18-30 year old African women:     rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also     examines adherence to the dosage forms through objective markers, developed for each dosage     form prior to the commencement of the study.   "
52195|NCT02602353|"     The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain     patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle     Soreness (DOMS).   "
52196|NCT02602340|"     This project aims to identify brain and behavioral characteristics of individuals     experiencing symptoms of depression that will predict the effectiveness of Behavioral     Activation Therapy. Brain imaging aspects of the study will use functional magnetic resonance     imaging (fMRI) and electroencephalography (EEG). Behavioral assessments will include     self-report questionnaires, computer-based and observational tasks, and interviews.     Assessments will focus on how individuals process positive information (such as reward) and     negative information (such as distressing images), as well as how people make decisions.     These assessments will be conducted across 2-3 in-person sessions prior to beginning the     treatment, and will be repeated across 2-3 in-person sessions after completing treatment. A     blood draw will also be conducted pre- and post- treatment. Behavior Activation therapy will     consist of 10, 90-minute weekly therapy sessions conducted in small groups.   "
52197|NCT02602327|"     This is a phase I dose escalation study (3+3 design) with a dose expansion arm (12 patients)     designed to evaluate safety of the combination of Tas-102 and radioembolization using     Yttrium-90 (90Y) resin microspheres for patients with chemotherapy-refractory liver-dominant     chemotherapy-refractory metastatic colorectal cancer (mCRC).   "
52198|NCT02602314|"     The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline     therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined     by the ELN criteria.   "
52199|NCT02602301|"     Objective: To evaluate the relationship between intravenous (IV) infusion of oxytocin using     either saline 0.9% or glucose 5% & neonatal Bilirubin & sodium level.      Study Design: A randomized case - controlled study. Setting: The Obstetrics and Gynecology     casuality department of Kasr El Aini hospital (Cairo University - Egypt)   "
52200|NCT02602288|"     The purpose of this randomized controlled trial is to develop and test the efficacy of a     multilevel, multimodal intervention designed to reduce children's exposure to secondhand     tobacco smoke (primary outcome) and promote smoking cessation in mothers (secondary outcome).     Low-income mothers who smoke and their children will be enrolled from the supplemental     nutrition program, Women, Infants and Children (WIC) clinics. All mothers visiting WIC     clinics will receive a clinic-level intervention, which consists of nutrition counselors     following an ask, advise, and refer protocol to identify children exposed to secondhand     tobacco smoke, advise mothers who smoke about the harms of such exposure and the benefits of     reducing exposure, and referring mothers to the trial. Screened eligible mothers will be     consented and randomized to an attention control condition focused on nutrition (CTL) or to     an experimental (EXP) multimodal behavioral intervention that integrates telebased counseling     to promote reduction of child secondhand smoke exposure (SHSE) and maternal smoking with an     adjunct smoking cessation mobile app and nicotine replacement therapy use. The investigators     will test the primary hypothesis that relative to children in the CTL condition, those in the     EXP condition will have lower exposure SHSE as measured by mothers' reports and child     cotinine levels. The investigators will also test the secondary hypothesis that relative to     mothers in the CTL condition, those in the EXP condition will have higher bioverified 7-day     point prevalence quit rates. In addition, the study will: (a) evaluate if specific     psychosocial and behavioral factors-- social support, urge coping skills, self-efficacy, and     SHSe protective behaviors--mediate the effects of the EXP intervention on outcomes and (b)     explore whether other residential smokers, level of nicotine dependence, depressive/anxious     symptoms, weight concerns, intervention dosage, and pregnancy status predict outcomes and     moderate treatment effects.   "
52201|NCT02602275|"     The purpose of this study is to explore the effect of Neurexan® on the brain response when     participants undergo an emotional stressful condition in verum compared to placebo.   "
52202|NCT02602262|"     HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from     an HIV+ deceased donor will be followed to determine the safety and efficacy of this     practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected     (HIV-) donors will also be followed.   "
52203|NCT02602249|"     In this study, safety and effects of MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL on human     gastric cancer are going to be investigated.   "
52204|NCT02602236|"     The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.   "
52205|NCT02602223|"     The purpose of this study is to examine if a biologically active commercially available     amnion chorion membrane (ACM) is as effective as the commercially available inert dense     polytetrafluoroethylene membrane (D-PTFE) in preserving jaw bone dimensions and whether it     provides the added benefit of reducing post-operative discomfort after dental surgery   "
52208|NCT02602184|"     This clinical study will be a prospective, placebo-controlled, double-blind, randomized and     centrally evaluated intra-individual comparative study to assess the safety and efficacy of     AR/101 concomitantly administered with Standard of Care (SoC) in accelerating re     epithelialization of split thickness wounds compared with placebo and concomitantly with SoC,     in the pannus of volunteers undergoing elective abdominoplasty.   "
52209|NCT02602171|"     The present study has the evaluation of a test to measure the localization performance goal .     It is about the perception of danger audio signals in everyday listening environments nearby     which are reproduced in controlled laboratory conditions. In addition, a dereverberation     algorithm regarding speech intelligibility and localization ability is evaluated . The     research hypothesis is that the dereverberation of the audio signals can improve speech     intelligibility for both normal hearing and hearing-impaired persons. In addition, the     binaural dereverberation algorithm should not affect the localization ability in everyday     situations.   "
52210|NCT02602158|"     13C breath tests represent an attractive alternative in the measurement of gastric emptying     (GE). Therefore these tests have been used in a variety of clinical settings such as in the     assessment of gastroparesis, delayed GE in diabetic patients or in the assessment of GE with     fat containing enteral formulas in critically ill patients.      The investigators have previously demonstrated that the 13C sodium octanoate breath test     (OBT) is an inappropriate measurement method for the GE of fat. The OBT appears to be     affected by 1) post gastric processing of the OCC marker and 2) its interaction with the     physical form and concentration of the fat present in the stomach and duodenum.      The13C trioctanoate breath test (TriOBT) represents an attractive alternative to the OBT.     Compared to OCC which is a medium chain fatty acid the 13C trioctanoate (TriOCC) is a     triglyceride. TriOCC has similar physio chemical properties as the nutritional lipid e.g.     rapeseed oil.      This study aims to assess the efficacy of the TriOBT as a GE measurement method of fat in an     acid stable lipid emulsion (LE1). The breath test results from the TriOBT will be compared     with the OBT and further validated against gastric fat volume emptying data observed from     MRI. The interim analysis will determine whether the study will proceed to stage 2 which will     assess the efficacy of the TriOBT in an acid unstable lipid emulsion (LE4).   "
52211|NCT02602145|"     Angioplasty and stenting for atherosclerotic occlusive disease in the arteries supplying the     legs (Peripheral Arterial Disease, PAD) is the most common endovascular procedure outside of     the heart, but carries the highest rate of reconstruction failure. The underlying reasons for     these poor results are not completely clear, but the main arterial segment within the leg,     the femoropopliteal artery, appears to be significantly different from other peripheral     arteries because the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) that comprise     the femoropopliteal artery segment, undergo large deformations during flexion of the limb. In     our NIH application we propose to accurately measure these deformations using human cadavers     and build mathematical models of human femoropopliteal arteries repaired with several     frequently used PAD stents. These mathematical models would be able to assess the mechanical     stress in the stented SFA and PA associated with limb flexion and predict disease recurrence     for arteries with different patient and lesion characteristics. Results of model predictions     will be validated in patients with PAD stents who have received these stents as part of their     standard of care.   "
52222|NCT02601989|"     The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin     resistance, including glucose metabolism and subclinical inflammation, after a 6-week     administration of tadalafil in T2D patients. The primary objective is to study the effect of     tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic     clamp.      This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five     T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for     six weeks and after a wash-out period of eight weeks intake of placebo for another six weeks,     or vice versa. At the end of each 6 week treatment period a glucose clamp, subcutaneous     needle biopsies as well as muscle and subcutaneous microdialysis will be performed.     Endothelial function tests and arginin stimulation of insulin secretion tests will be     performed after 3 weeks in each treatment arm.   "
52212|NCT02602132|"     The study will be conducted at University Hospital Alcorcón Foundation, belonging to the     public network of hospitals of Madrid Health Service.      The aim of this study is to evaluate the effects of clamping the urethral catheter prior to     removal and determine which of the two options (clamping or free drainage) is the most     recommended for removal of bladder catheterization in adults.      The interest of this study is given by the importance of proper handling of catheterization     in the health of patients admitted to a hospital and are subjected to this technique.     Increase its interest the need for implementation of evidence-based care, and limited     scientific literature on the subject.      The study population will be patients undergoing short-term urethral catheterization at the     Internal Medicine Service in the University Hospital Alcorcón Foundation.      The methodology of the study is experimental, randomized clinical trial without drug type.     Interventions (prior clamped and free drainage) will be assigned in a randomized manner.      Interventions and data collection of patients who met the inclusion criteria to join the     study will be conducted during 2016 and the first quarter of 2017. It is planned to present     results at the end of 2017.      Keywords: BLADDER TRAINING, INDWELLING CATHETER, URINARY CATHETER, URETHRAL CATHETER,     CLAMPING, REMOVAL, ACUTE URINARY RETENTION.   "
52213|NCT02602119|"     The primary end-point of the study is to determine the sensitivity of OTL in identifying lung     nodules when excited by an imaging probe. Investigators intend to enroll 50 lung cancer     patients in this study. The study is focusing on patients presenting with suspected     malignancies of the lung and pleura who are considered to be good surgical candidates.   "
52214|NCT02602106|"     Aquatic activities is one of the most attractive physical exercise during pregnancy,     especially during the third trimester.   "
52215|NCT02602093|"     Rationale: Lumbosacral radicular syndrome (LSRS) is caused by a herniated lumbar nucleus     pulposus (HNP) and the estimated annual incidence in The Netherlands ranges between 60,000 to     75,000 people. Open microdiscectomy is the standard surgical technique.      In recent years, several surgical techniques have been developed including, percutaneous     transforaminal endoscopic discectomy (PTED). While PTED is gaining popularity in The     Netherlands, evidence of its effects is lacking, leading to a heated debate. The current     position of Zorginstituut Nederland (ZiN) is that there is insufficient evidence to support     its use; therefore, PTED is not financially covered. The consequence is, patients are forced     to pay the costs of treatment themselves. This study is expected to provide the necessary     data to answer the question regarding effects and costs of PTED vs. open microdiscectomy, and     help resolve the current debate.   "
52235|NCT02601807|"     The ActiPatch is a cutaneous device which is CE marked approved for relief of pain. It is     taped over the affected area and stimulation at a high frequency is reported to alleviate     pain with no sensation. However there is no class 1 evidence for this on back pain. By     randomising patients between application of an active device or a dummy device and assessment     of disability and pain scores at two weeks, the efficacy or otherwise can be established. Low     back pain is a major health problem and if effective this has major economic implications as     the device is cheap and safe.   "
52216|NCT02602080|"     Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and     cause unexpected hospital admissions. The trend toward ambulatory surgery has increased the     focus on postoperative nausea, but published evidence is not based on standardized criteria     for assessment. Therefore, the results for postoperative nausea are very diverse, especially     reports on nausea incidence after regional anesthesia, i.e. spinal anesthesia. When     peripheral nerve blocks have been applied for postoperative pain control, they significantly     reduce postoperative pain, opioid consumption and side effects; patients receiving general     anesthesia (GA) and nerve blocks are thought likely to have less nausea than patients     receiving GA alone. This study is a pilot study looking at the incidence and intensity of     nausea after orthopedic surgery under nerve blocks in foot and ankle (FA) patients and under     nerve blocks with either sedation or GA in total shoulder arthroplasty (TSA) patients. The     results of this study will help power a future randomized controlled trial, comparing the     incidence and intensity of nausea in FA patients receiving GA through laryngeal mask airway     (LMA) versus spinal anesthesia.   "
52217|NCT02602067|"     Tenatumomab is a Sigma-Tau developed new anti-Tenascin antibody. It is a murine monoclonal     antibody directed towards Tenascin-C. By means of this antibody, Tenascin-C expression was     studied on a commercial tissue array slides each carrying malignant breast, colorectal, lung,     ovarian or B and T cell Non-Hodgkin Limphoma tissue sections. All these cancers type showed     positivity to Tenascin-C between the 64% and 13.3%. Consequently, Sigma-tau is exploring the     use of the 131I-labeled Tenatumomab for anti-cancer radioimmunotherapy.   "
52218|NCT02602054|"     The decision to treat patent ductus arteriosus in preterm infants, varies from a     conservative, medical or immediate surgical treatment; although, at present, there is some     controversy about this decision. This study aims to determine the efficacy and safety of     surgical versus pharmacological treatment of patent ductus arteriosus in preterm infants.   "
52219|NCT02602041|"     The investigators will perform a pilot study to gain insight into attitudes, barriers and     facilitators for health behavior change in cancer patients and their partners. Results of     this pilot will be used to design suitable questionnaires to investigate health behavior     change in a larger cohort of patients and their partners. It will also direct future     interventions to adequately target patients and, potentially, their partners to improve their     lifestyle following a cancer diagnosis.   "
52220|NCT02602028|"     It was aimed to examine the efficacy and safety of once daily dosage schema of colchicine in     pediatric patients with FMF compared to twice daily dosage schema.      In this 24-week, multicentric, randomized, controlled, noninferiority trial, pediatric     patients newly diagnosed with FMF, carrying homozygote or compound heterozygote mutation and     did not receive any treatment, were included. Patients were randomly assigned using block     randomization method to receive treatment with once or twice daily doses. Clinical and     laboratory characteristics and medication side effects were recorded and compared between     groups. The study complied with Good Clinical Practice and the Consolidated Standards for     Reporting of Trials (CONSORT) statement.   "
52221|NCT02602002|"     This was a single centre, randomised, double blind, placebo controlled, two-way cross-over     design study to assess the feasibility of pain PD tests and to determine the variability and     effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy     volunteers.   "
52223|NCT02601976|"     Hepatitis C is a global problem, prevalent in developed as well as in the developing     countries. New treatment regimens using PegInterferon in combination with ribavirin has led     to improved sustained viral response rates for some genotypes. A single arm, open labeled,     multicentre trial was conducted to evaluate the response rate and safety of PegInterferon     alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic     hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for     genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality     of life at baseline and at follow-up visits were determined using SF-36.   "
52224|NCT02601963|"     The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it     helps people with moderate-to-severe papulopustular rosacea.      The investigational product is FMX-103 minocycline foam. Two concentrations of the     investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be     applied once daily to the face for the 12-week treatment duration of the study.      Approximately 210 patients will participate in this study.   "
52234|NCT02601820|"     The PROP UP research study is funded by The Patient Centered Outcomes Research Institute     (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate     all-oral treatment regimens for HCV regarding several patient-reported outcomes (PROs) such     as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket     costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare     PROs of different treatment regimens, treatment durations, and patient subgroups.     Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with     HCV infection who are prescribed a regimen containing Harvoni®, Viekera Pak®, Zepatier®,     DAC/SOF or SOF/VEL for chronic HCV will be recruited and approximately 1600 patients who are     approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will     be evaluated before, during and after HCV treatment.      PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient     engagement group and a patient advocacy organization.   "
58102|NCT02525055|"     The investigators conducted an initial safety and characterisation study in healthy adult     volunteers, utilising a unique clinical quarantine facility in London, UK.   "
52225|NCT02601950|"     This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg     BID administered orally in continuous 28 day cycles. Screening of subjects to determine     eligibility for the study will be performed within 21 days of the first planned dose of     tazemetostat. Eligible subjects will be enrolled into one of fivecohorts based on tumor type:        -  Cohort 1: MRT, RTK, ATRT, or selected tumors with rhabdoid features, including small          cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid          tumor of the ovary [MRTO]        -  Cohort 2: Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement        -  Cohort 3: Other INI1 negative tumors or any solid tumor with an EZH2 gain of function          (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST),          extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative          malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor          with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma        -  Cohort 4: Renal medullary carcinoma (RMC)        -  Cohort 5: Epithelioid sarcoma (ES)      Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or     withdrawal of consent, or termination of the study. Response assessment will be evaluated     after 8 weeks of treatment and then every 8 weeks thereafter while on study.   "
52226|NCT02601937|"     This is a Phase I, open-label, dose escalation and dose expansion study with a BID oral dose     of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned     first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be     evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study.      The study has two parts: Dose Escalation and Dose Expansion.      Dose escalation for subjects with the following relapsed/refractory malignancies:        -  Rhabdoid tumors:        -  Atypical teratoid rhabdoid tumor (ATRT)        -  Malignant rhabdoid tumor (MRT)        -  Rhabdoid tumor of kidney (RTK)        -  Selected tumors with rhabdoid features        -  INI1-negative tumors:        -  Epithelioid sarcoma        -  Epithelioid malignant peripheral nerve sheath tumor        -  Extraskeletal myxoid chondrosarcoma        -  Myoepithelial carcinoma        -  Renal medullary carcinoma        -  Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor          approval)        -  Synovial Sarcoma with a SS18-SSX rearrangement      Dose Expansion at the MTD or the RP2D        -  Cohort 1 - ATRT        -  Cohort 2 - MRT/RTK/selected tumors with rhabdoid features        -  Cohort 3 - INI-negative tumors:             -  Epithelioid sarcoma             -  Epithelioid malignant peripheral nerve sheath tumor             -  Extraskeletal myxoid chondrosarcoma             -  Myoepithelial carcinoma             -  Renal medullary carcinoma             -  Chordoma (poorly differentiated or de-differentiated)             -  Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor               approval        -  Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with          SS18-SSX rearrangement   "
52227|NCT02601924|"     Eighty patients with inclusion criteria will participate in this studyEach patient will     receive an injection in one of the following groups according to the random number table:        1. Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)        2. Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB        3. Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)        4. Group TGI: Topical gel with a MAI. Immediately after the injection, patients will be          asked to record the amount of pain they felt during needle penetration and injection          using VAS form.Data will be analyzed using ANOVA and t-test.   "
52250|NCT02601612|"     The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2     vaccine in RSV-seropositive children and RSV-seronegative infants and children.   "
52253|NCT02601573|"     This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose     combination (FDC) of elbasvir (50 mg)/grazoprevir (100 mg) (EBR/GZR) and 400 mg of sofosbuvir     (SOF), with and without ribavirin (RBV), in treatment-naïve (TN) and treatment-experienced     (TE) subjects with chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) infection with     compensated cirrhosis.   "
52228|NCT02601911|"     The aim of this study is effect of premedication on success of inferior alveolar nerve block     injection. Sixty healthy adult volunteers including criteria, are participating. The patients     will be divided into 3 groups and will be randomly given one of premedications including 1)     10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes     before applying the injection. All patients will receive standard Inferior Alveolar Nerve     Block injection . Patients with no lip numbness and positive responses to cold and electric     pulp tests would be excluded from the study. Endodontic access preparation will be initiated     15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be     recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or     mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working     lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.   "
52229|NCT02601898|"     The aim of this study was to compare the therapeutic efficacy of lipoic acid versus     progesterone by vaginal administration on subchorionic hematoma resorption in women at the     first trimester of pregnancy with threatened miscarriage.   "
52230|NCT02601885|"     This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and     immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).   "
52231|NCT02601859|"     The project is designed to generate critical information to design and justify a robust trial     on lithium prevention of the onset of Alzheimer's disease (AD). Lithium exerts and inhibitory     effect on Glycogen synthase kinase 3 (GSK-3) a brain biomarker of neuroprotection. The study     consists of 3 phases:        1. Phase 1 investigates rats to establish a reliable method to measure brain biomarker          activity levels from blood biomarker activity.        2. Phase 2 will determine whether the GSK3 enzyme activity is significantly different in          subjects with MCI compared to normal individuals.        3. Phase 3 investigates patients with MCI taking lithium to establish the minimum lithium          dose required to inhibit the activity of GSK-3.   "
52232|NCT02601846|"     A multicentre multinational prospective management outcome study has recently proven the     safety of a diagnostic strategy combining clinical probability assessment with an     age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for     ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE.     Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers,     as it allowed ruling out PE without further investigation in a significantly higher     proportion of patients than when using standard cut-off, particularly so in patients 75 years     or older.      The objective of the present study is to confirm in a prospective cohort of real life     patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients     presenting to the emergency department with suspected PE.   "
52236|NCT02601794|"     The investigators are conducting a web-based study to explore the use of a mindfulness app to     improve quality of life among women with breast cancer.      Eligible participants will be asked to provide informed consent to participate and submit a     data authorization form to obtain information from the app at the end of the project.      This 12-week project will randomly assign participants to one of two groups:      Group 1 (AMT) will receive the mindfulness app right away; Group 2 (WC) will receive the     mindfulness app at the end of 12 weeks.      All participants will receive a welcome email with group designation. Participants assigned     to Group 1 (AMT) will also receive app download instructions and pass code. Group 1 will be     asked to complete the app's first 10-minute mindfulness exercise, at minimum.      Participants assigned to Group 2 (WC) will be notified that they will receive app download     instructions and pass code at the end of 12 weeks.      Regardless of group assignment, all participants will be asked to complete web-based survey     assessments 4 different times throughout the study (baseline, week 5, week 9, 12-week follow     up). The surveys will be related to quality of life, mindfulness, mobile technology, health     literacy, and chronic pain.      To encourage participation, a member of the study team will send out weekly check-in emails.      Once all data has been collected, app developers will provide the investigators with app data     for each participant, including times accessed, length of time using app. This information     will help the investigators observe which app characteristics are most useful, as well as the     optimal amount of time needed to obtain benefit from the app.      The investigators goals are to understand how using the mindfulness app compares to not using     the mindfulness app. The investigators will also observe whether the app contributes to     participants' quality of life. The investigators also want to understand more about how women     use health apps overall. This information may inform issues related to delivery of app-based     health interventions among women with breast cancer.   "
52237|NCT02601781|"     BVS STEMI STRATEGY-IT is a spontaneous, prospective, non-randomized, single-arm multicenter     registry on consecutive STEMI patients eligible to undergo primary percutaneous coronary     intervention (PPCI) with BVS implantation on the basis of the pre-specified inclusion and     exclusion criteria.      This registry has the objective to assess the immediate (peri-procedural and 30 days), mid (6     months and 1 year) and long-term (3 and 5 years) results following BVS implantation using a     pre-specified implantation strategy during PPCI in STEMI subjects.   "
52238|NCT02601768|"     The aim of this study is to determine whether three-dimensional tranesophageal     echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be     as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during     transcatheter closure of the defect.   "
52239|NCT02601755|"     Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain that     is not treated properly can reduce quality of life. Programs to help AYA learn to live with     and manage pain are very important. Our team is developing a smartphone application (app) and     website for AYA with chronic pain. The app will help AYA to track pain, sleep, mood,     activities, and exercise and help AYA set and achieve goals. The website will give     information about pain and how to manage it independently. We will build the program and make     sure it is easy to use and understand. We will also test if the program can be put into     practice as planned and if AYA using the program feel less pain, have less limitations, and a     better quality of life.   "
52251|NCT02601599|"     Background: Smoking counselling during hospitalisation with post-discharge follow-up     increases quitting. However, provision of cessation care for hospitalised patients is     suboptimal. Students are potentially an untapped resource for providing cessation advice, but     no studies have investigated this.      Aim: To determine if medical students can encourage motivation to stop smoking (MTSS; primary     outcome) in hospitalised smokers .      Design: 2-arm RCT Setting: RCSI (www.rcsi.ie) and Connolly Hospital     (www.hse.ie/eng/services/list/3/hospitals/Connolly/).      Participants: Inpatient smokers. Intervention and procedures: 60 graduate medical students     will receive standardised motivational interviewing training in the provision of cessation     advice. Each student will be randomly assigned to counsel ~1-3 smokers each, including an     individual in-hospital, face-to-face session and post-discharge phone counselling. Training     and implementation will cover Sept-2015-May-2016. Smokers will be randomised to 'usual care'     (n~90), or intervention (n~90, student-delivered motivational interviewing). A researcher     will enable recruitment and follow-up, and conduct a qualitative evaluation of programme     participants.   "
52240|NCT02601742|"     Acute diarrhea is the third cause of infant mortality in the world causing 15% of all deaths     in children under 5 years and is responsible for nearly 1.4 million deaths in developing     countries. It is considered a self-limiting disease and to this problem the recommendation of     the World Health Organization (WHO) is the administration of zinc with low osmolarity oral     dehydration salts for a period of 10-14 days which reduces the severity of the episode.      In Mexico COFEPRIS believes the zinc salt as a food supplement and not a drug and the above     problem is presented in terms of prescribing and access of this salt to the general     population. In Mexico the investigators have the provision and accessibility of low     osmolarity oral dehydration salts supplemented with adequate doses of zinc, which is     inexpensive for the general population and offering a solution in terms of supply and     management.      The purpose of the study involves the evaluation Pedialyte diarrhea in the treatment of acute     diarrhea in children under 5 years. The investigator sconsider the use of Pedialyte diarrhea     eases their access to the population in general and it is low cost compared with the zinc     salt that is sold only in specialized pharmacies under strict medical prescription Objective:     Compare the duration of symptoms of acute diarrhea in the treatment with low osmolarity oral     rehydration salts (Pedialyte) vs treatment of low osmolarity oral rehydration supplemented     with zinc (Pedialyte diarrhea) Study Desing: Double blind, randomized, controlled.   "
52241|NCT02601729|"     Type 1 diabetes mellitus (T1DM) is an autoimmune disease caused by an immune mediated     destruction of the pancreatic β-cells. Once the pancreas has been depleted of a critical mass     of β-cells the need for exogenous insulin therapy emerges. Several methods exist to     administer insulin. An alternative way to administer insulin is by means of continuous     subcutaneous insulin infusions (CSII) or insulin-pump therapy.The frequent execution of     self-monitoring of blood glucose (SMBG) accomplished by a capillary finger-stick test is     essential in the management of diabetes, but this is very limited and also lacks information     about rising or falling trends in the actual glycaemia. A solution for this is the use of a     Real-Time Continuous Glucose Monitoring (RT-CGM) device. Contrary to SMBG, RT-CGM measures     glycaemia 24 hours a day, provides information about glucose direction and rate of change     during multiple days a week. Since September 2014, RT-CGM is reimbursed in Belgium for a     selected group of type 1 diabetic patients by means of a so-called CGM convention. The main     objective of the study is to evaluate the impact of real time continuous glucose monitoring     reimbursement on real-life clinical care parameters of type 1 diabetic patients in Belgium     after 12 and 24 months.   "
52242|NCT02601716|"     This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of     PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult     subjects.   "
52243|NCT02601703|"     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study     to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark     Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas     Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).   "
52244|NCT02601690|"     This is a research study intending to look at the response of a specific type of allergy     cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs     (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a     non-interventional study in which no investigational product will be administered to any     subject.   "
52245|NCT02601677|"     Nucleus accumbens/anterior limb of internal capsule play important roles in the process of     treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus     accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively     prevent the disorder.   "
61929|NCT02475005|"     The purpose of this study is to test the efficacy of a new app to help adolescents with     chronic or reoccurring headaches self manage pain.   "
52246|NCT02601664|"     Design: Single center, single-blind randomized controlled trial of patients with high risk     native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block     chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will     be randomized to either a combined intervention or conventional PCI. Cardiac biomarker     measurements will be performed before PCI and 18-24 hours later.      Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and     glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and     complete coverage of the lipid core plaque, if technically feasible.      Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to     compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI     troponin distribution in the two study groups.      The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of     normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3)     Lower incidence of major adverse cardiac events, defined as the composite of death, acute     coronary syndrome, or coronary revascularization) during 30-day follow-up.   "
52247|NCT02601651|"     The primary objectives of this study is to access the effect of perioperative lidocaine     infusion on total morphine requirement during the first 24 h postoperatively in patients who     underwent laparoscopic totally extraperitoneal inguinal hernioplasty.   "
52248|NCT02601638|"     Patients undergoing total laryngectomy are at high risk for 30-day unplanned readmission.     Many of these readmissions are related to stomal care, and it is thought that the     readmissions could be prevented with better patient and caregiver education. The     investigators are studying the effect of a comprehensive perioperative education program on     30-day unplanned readmission for patients undergoing total laryngectomy.      The comprehensive perioperative education program will include the following additional     interventions:      -Preoperative visit with the speech pathologist for explanation of laryngectomy physiology,     stomal education, and alaryngeal voice rehabilitation. Participants will be expected to     undergo this intervention and to attend it with their laryngectomy coach (a family member     or friend to accompany the patient through the education process), but failure to meet with     the speech pathologist will not exclude a patient from the study.        -  Preoperative education class with a designated ENT laryngectomy nurse for patient and          caregiver. The hands-on class introduces the patient and laryngectomy coach to the          basics of stomal care. Participants and their laryngectomy coach will be expected to          attend the preoperative education class        -  Printed laryngectomy journey guide given to patients at time of study enrollment for          patient/caregiver. This journey guide details the preoperative, in-hospital, and          post-discharge course and is provided as a reference throughout their journey.        -  Formalized, nursing administered practical evaluation of minimal competency of          laryngectomy care for patient and caregiver/laryngectomy coach.      This study will follow patients prospectively from the time of study commencement and then     assess changes in patient knowledge before and after the education intervention. It will also     compare rate of stomal complications and readmission rates to institutional historical     averages to assess improvement in quality care.   "
52249|NCT02601625|"     This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the     Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy     subjects   "
52256|NCT02601534|"     The goal of the study is to evaluate the effectiveness of a family-focused and interactive     intervention for reducing the sedentary behavior and increasing physical activity of the     participants. The intervention is to use the concept of zero time, zero money, and zero     equipment (3 Zero exercise), which aims to get sedentary people to start exercising. The     intervention aims to encourage positive and sustainable health actions among participants and     their family members.   "
52257|NCT02601521|"     Specific Aim: To conduct a randomized controlled trial among permanent employees of Partners     HealthCare, Inc., and their adult dependents, who are current tobacco smokers. The trial will     compare two interventions designed to help smokers stop using tobacco: (1) External Coaching     Program (Standard Care) and (2) Internal Coaching Program, a chronic disease management     strategy for treating tobacco use and dependence.   "
52258|NCT02601508|"     This study is designed to evaluate the surgeon's satisfaction with either deep or moderate     neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery     profiles in the recovery room and the ward.The explorative objective of this study is to     evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of     postoperative complications.   "
53775|NCT02581709|"     The goal of this research study is to test the feasibility of an intervention programme to     reduce cognitive impairment due to cancer treatment. The investigators want to find out how     acceptable the intervention and procedures are for cancer patients.   "
52259|NCT02601495|"     In this study the investigators will seek to improve their understanding of how positive and     negative valence systems, cognition, and arousal/interoception are inter-related in disorders     of trauma, mood, substance use, and eating behavior for women involved in a court diversion     program in Tulsa, Oklahoma (Women in Recovery). The investigators will recruit 100     individuals and use a wide range of assessment tools, neuroimaging measures, blood and     microbiome collections and behavioral tasks to complete the baseline and follow-up study     visits. Upon completion, the investigators aim to have robust and reliable dimensional     measures that quantify these systems and a set of assessments that should be recommended as a     clinical tool to enhance outcome prediction for the clinician and assist in determining who     will likely benefit from the diversion program, and to inform future revision or augmentation     of the program to increase treatment effectiveness.   "
52260|NCT02601482|"     A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and     time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The     time spend with high-intensity (fast) walking is considered to be responsible for the     improvements seen, whereas the time spend with low-intensity (slow) walking is considered     less important.      This study will assess if IW with maintained fast walking time duration but reduced total     time duration (i.e. reduced slow walking time duration) is equally effective as IW with a     normal time duration.      Subjects with type 2 diabetes will be included in a crossover, controlled study, where each     subject will undergo three trials. Trials will be identical except the following     interventions:        1. Sixty minutes of rest (CON)        2. Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3          minutes of slow walking; IW-60)        3. Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of          fast and 1.5 minutes of slow walking; IW-45).      After the interventions subjects will undergo a standardized mixed meal tolerance test with     assessment of glycemic control.   "
52261|NCT02601469|"     An open label, safety study to assess the potential for adrenal suppression following maximal     use treatment with DSXS administered twice daily for 28 days in patients with moderate to     severe plaque psoriasis.   "
52262|NCT02601456|"     The purpose of this study is to determine the effect of prolonged effort in long distance     running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee     running with running specific prosthesis.   "
52263|NCT02601443|"     The incidence of multiple gestations has increased over the past years, mostly because of     increased use of assisted reproductive technologies. Triplet pregnancies are at increased     risk of preterm birth (PTB), which is the primary reason for their increased morbidity and     mortality compared to singletons. Multiple gestations, including triplets, account for about     3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very     low birth weight infants, and nearly 20% of infant mortality.      A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good     predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a     short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and     perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the     contrary, the effect of cerclage in multiple gesttations has been insufficiently studied,     with meta-analysis data showing a possible harm from cerclage compared to controls.      The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in     unselected triplet gestations.      We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU     CL <30 mm)   "
52264|NCT02601430|"     The purpose of this study is to determine if an MRI technique called Blood Oxygen Level     Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment     with standard endovascular therapy in patients with chronic lower limb ischemia.   "
52265|NCT02601417|"     Acute cholangitis with obstructive jaundice is a condition which needs biliary drainage and     appropriate antibiotics. Bile culture is an optional laboratory test according to 2013 Tokyo     guideline, but the clinical significance is yet unproven. And its results might indicate less     information of the true pathogen regarding normal flora. Previous study conducted at our     institute found drug-resistant pathogens identified in bile culture had no impact on the     outcome. So the investigators are conducting a multicenter randomized controlled trial     comparing groups which considers both blood and bile culture as control and which considers     only blood culture as trial group in order to prove bile culture provides no additional     helpful clinical information.   "
52291|NCT02601079|"     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this     study are as follows:        -  Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to          establish the correct diagnosis based on collected biopsies of tumors in the upper GI          tract.        -  Based on the quality of the collected tissue samples we want to evaluate which          instrument generates the most useful material for genetic studies of the tumor.   "
52266|NCT02601404|"     Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients     with coronary artery disease. However, a continued risk of clinical events even several years     after the procedure is reported. Stent platform or polymer-associated inflammation may play a     role.      Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which     may result in the more favorable very long-term clinical outcomes compared with metallic     stents. The initial clinical experiences of BRS in relatively simple lesion subsets were     comparable to DESs.      BRS, however, is limited by the disadvantageous mechanical characteristics such as thick     strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for     complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse     long lesions. Real world registry is needed to test the feasibility and safety of BRS in     these complex lesion subsets.   "
52267|NCT02601391|"     The purpose of this study is to determine how effective the STEPPS-HI group is at improving     emotional regulation skills in those with identified difficulties in this area within     forensic inpatient services. In addition, to explore whether there is increased acceptability     of the adapted STEPPS group (STEPPS-HI) for this client group.   "
52268|NCT02601378|"     This study is to characterize the safety, tolerability, pharmacokinetics (PK),     pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent in     patients with metastatic uveal melanoma.   "
52269|NCT02601365|"     This study will investigate the safety and efficacy of the administration of inhaled GM-CSF     to children with respiratory virus-associated pneumonia.   "
52270|NCT02601352|"     The study mainly focuse on examining the subjects living in traffic polluted area with     elevated blood pressure and assessing the popuation health risk using disease and risk     assessment models.   "
52271|NCT02601339|"     This study is to use advanced near-infrared spectroscopy (NIRS) technology for monitoring     cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) in newborns that developed     germinal matrix-intraventricular hemorrhage (GM-IVH) and post-hemorrhagic hydrocephalus (PHH)     at the bedside. We hypothesize that baseline cerebral metabolic dysfunction is a better     biomarker for GM-IVH and PHH severity and response to PHH treatment.      This is a multi-center study at Massachusetts General Hospital (MGH), Brigham and Women's     Hospital (BWH) and Boston Children's Hospital (BCH). The Partners Institutional review board     (IRB) has approved the protocol to conduct study at BWH and MGH. The IRB protocol at BCH is     at the final stage of approval.      Dr. Pei-Yi Lin receives the funding from National Institute of Health (NIH) to support the     study and is the overall principal Investigator (PI) overseeing the study.   "
52272|NCT02601326|"     A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's     procedure in treatment of complete rectal prolapse to ass both efficacy and complications   "
52273|NCT02601313|"     Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of     KTE-C19 in subjects with Relapsed/Refractory MCL   "
52274|NCT02601300|"     This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral     GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and     a Mayo endoscopic subscore≥ 2.      Approximately 40 subjects will be enrolled using an Interactive Voice Response System (IVRS)     or an Interactive Web Response System (IWRS) to receive open-label, oral GED-0301 160 mg for     duration of 52 week treatment. Enrollment of subjects with previous exposure to TNF-α     blockers will be limited to approximately 15 subjects. The number of subjects with extensive     colitis is targeted to comprise approximately 50% of the entire study population.   "
52275|NCT02601287|"     This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of     Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or     Overactive Bladder.   "
52276|NCT02601274|"     A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability,     pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced     solid tumors   "
52277|NCT02601261|"     Investigating the influence of Internet use to the level of state anxiety in hospitalized     women with pathological pregnancy.      A recent research shown that the prevalence of antenatal anxiety changes during pregnancy at     first trimester is 36.3%; the rate dropped to 32.3% at second trimester but increased again     to 35.8% at third trimester (art. 29).According to the World Health Organization, mental     health disorders are the leading cause of disease burden in woman from 15 to 44 years     (art.6). A Swedish study indicated that the incidence of moderate or extreme symptoms of     anxiety and depression of pregnant woman during the first trimester is 15,6% (art. 3).   "
52278|NCT02601248|"     First-in-human study is conducted to assess the maximum tolerated dose (MTD) and     dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary     anti-tumor activity of Theliatinib .   "
52279|NCT02601235|"     Prospective, randomized, open label, parallel , multicenter clinical study, controlled by     active comparator ( 0.05 % Oxymetazoline Hydrochloride ) .      The investigators hypothesis is that pediatric Naridrin® nasal solution is superior to 0.05 %     Oxymetazoline Hydrochloride in improving nasal congestion.      Participants aged 10-17 years with a clinical diagnosis of nasal congestion of allergic or     inflammatory origin in at least one of the nostrils due to rhinitis or rhinopharyngitis will     be included in the trial.   "
52280|NCT02601222|"     The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in     treating chronic eczema.   "
52281|NCT02601209|"     This partially randomized phase I/II trial studies the side effects and best dose of     sapanisertib and to see how well it works compared to pazopanib hydrochloride in treating     patients with sarcoma that is too large to be removed (locally advanced) or has spread to     other areas of the body (metastatic). Sapanisertib and pazopanib hydrochloride may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
52292|NCT02601066|"     This research study includes patients ages 1 to 25 years old with Lamin A/C related muscular     dystrophy (LMNA-MD). The goal of this study is to evaluate how the heart is affected in     children and teens with LMNA-MD. The evaluation includes an echocardiogram, an     electrocardiogram, an electrophysiological study and the implantation of a subcutaneous ECG     holter monitor.   "
52742|NCT02595177|"     To compare refractive outcomes and patient's visual quality after bilateral cataract surgery     when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.   "
52282|NCT02601196|"     Hypothesis:      After reviewing the relevant medical data the investigators assume that treating a woman with     intramural fibroid not distorting the uterine cavity or mostly intramural with less than 50%     submucosal component with Ulipristal Acetate (UPA) for a 13 weeks course would reduce the     fibroid size and improve her chance for conceiving by IVF treatment.      Materials & Methods:      Study design: A proof of concept prospective not randomized study. The patients: About 20     women treated in the fertility and IVF unit after at least one IVF failure, with mostly     intramural (IM) fibroid [class 2-5 by FIGO (International Federation of Gynecology and     Obstetrics) classification system] in the size of >4 cm confirmed by Transvaginal ultrasound     (TVUS) and diagnostic hysteroscopy.      After US examination and diagnostic hysteroscopy to ascertain suitability for this study, the     investigators will offer a course of 13 weeks treatment with UPA 5 mg per day.      One month after cessation of treatment the investigators will perform another TVUS     examination & diagnostic hysteroscopy plus endometrial biopsy in order to assess the     endometrial & uterine status and will conduct an additional IVF cycle, using the same     stimulation protocol undertaken during the immediate cycle previous to the UPA treatment     course.   "
52283|NCT02601183|"     The cerebrovascular diseases can be approximately divided as two types, namely ischemic and     hemorrhagic stroke. Intravenous thrombolysis within 3-4.5 hours is highly recommended for     acute ischemic stroke patients. But it's difficult to diagnose the ischemic stroke with the     hemorrhagic stroke from the early symptoms and signs. It's with high risk of enlarging the     hematoma if the patients with hemorrhagic stroke received the thrombolytic drugs. And time     cost by CT or MRI examination is likely to responsible for missing the narrow time window and     poor prognosis of stroke patients. Consequently, seeking for a noninvasive, rapid, portable     and inexpensive diagnosis method which can sensitively distinguish the stroke type before CT     or MRI examination would be very helpful in treating the ischemic stroke patients.      Because of the blockage in the cerebral supply artery, the heat from circulatory system will     sharply decrease in infracted hemisphere among the ischemic stroke patients. The reduced     brain temperature influenced the temperature on the ipsilateral forehead according to the     data of our animal and preliminary clinical trial. In contrast, the temperature of the     ipsilateral hemisphere showed a mild increase among the ischemic stroke patients in our     preliminary experiment. The difference of the temperature tendency on the ipsilateral     forehead has a great chance to be an early physical mark.      In our study, 30 ischemic stroke patients and 30 hemorrhagic stroke patients will be     recruited. In the process of recruitment, the patients with acute stroke attack in no more     than 4.5 hours will be collected the temperature at the five point without head coverage,     including ipsilateral tempora, ipsilateral forehead, galbella, contralateral forehead, and     contralateral tempora. Then the stroke would be recruited into the ischemic and hemorrhagic     group according to the later CT or MRI results in the hospital. The accuracy and sensibility     of early brain temperature in distinguishing stroke type would be tested in comparison with     the diagnosis of imaging examination.   "
52284|NCT02601170|"     Severe hemophilia is characterized by frequent and lifelong bleeding, with more than 60% of     bleeds occurring into joints . Repeated joint bleeding leads to chronic synovitis, cartilage     damage and bony destruction. Currently available treatment of hemophilic arthropathy, such as     analgesics, NSAIDs, and hyaluronic acid (HA), are predominantly directed toward the     symptomatic relief of pain and inflammation, but they do little to reduce joint cartilage     degeneration.      Platelet-Rich Plasma (PRP) is a simple and minimally invasive method that provides a natural     concentrate of autologous growth factors from the blood. This method is now being     increasingly applied in clinical practice to treat musculoskeletal disorders, such as tendon     repairment and osteoarthritis. To the best of our knowledge, no study applies PRP for     arthropathy of knee joint in hemophilia patients. The aim of the study is to investigate the     efficacy, safety and duration of benefit of single PRP injection versus five weekly     intra-articular injections of HA in patients with hemophilic arthropathy of knee.   "
52285|NCT02601157|"     We had little experience in coronary intervention with recently introduced newer drug-eluting     stent (DES) platforms, despite great anticipation, and optimal duration of dual antiplatelet     therapy (DAPT) for these stent systems still needs to be established.      With a 2x2 factorial design for patients of stable angina or silent ischemia, the     investigators formulate a head-to-head randomized comparison between sirolimus-eluting Orsiro     stent with biodegradable polymer and polymer-free stent platform with the same     antiproliferative agent, Coroflex ISAR stent system. At the same time, clopidogrel treatment     is added to aspirin during the 3-months period after the stenting, and this abbreviated     duration of DAPT will be compared with conventional 1-year mandatory DAPT regimen in a 1:1     randomized stratification. 1-year target lesion failure (TLF) as a composite of cardiac     death, target vessel related myocardial infarction and clinically driven target lesion     revascularization will be identified as a primary efficacy outcome. And in addition to TLF,     definite or probable stent thrombosis and major bleeding events will also be counted as a     composite outcome of net adverse clinical events (NACEs) to comprehensively adjudicate the     efficacy and safety outcomes according to the difference of DAPT duration.      With this trial, you will be able to get clear insight on the behavior of newer DES     platforms. Reference data for the shortened mandatory DAPT regimen will also be delineated in     the selected patients, and it might be helpful to those who need it.   "
52286|NCT02601144|"     This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing     of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to     High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would     have significant clinical implications in the management of Freezing of gait (FOG) in these     PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could     have better effect on FOG than HFS and low frequency stimulation (LFS).   "
52287|NCT02601131|"     The purpose of this study is to identify how the platelet count, complement system and     endothelial markers are affected over time, after platelet transfusion in 4 different     hematological patient groups.   "
52288|NCT02601118|"     This study was undertaken to investigate the effectiveness of the Micro Expression Training     Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal     communication skills of medical students.   "
52289|NCT02601105|"     The purpose of this study is to clinically evaluate the efficacy, safety as well as patient     satisfaction in the use of topical Centella asiatica (CA) on the cosmetic appearance of     stretch marks.   "
52290|NCT02601092|"     Several retrospective studies have shown same efficiency in regard to weight loss, with a     lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to     Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial     is to compare the two procedures in respect of excess weight loss, complications, operation     time, length of stay and the metabolic impact on the hormonal brain-gut-axis.   "
52470|NCT02598739|"     The aim of this study was to assess the effectiveness of resistance training in improving     functional capacity, muscle strength, quality of life and disease activity in patients with     PSA.   "
52293|NCT02601053|"     For centuries the term blood curling has been used to describe extreme frightening     situations. However, the origin of this ancient theory has never been studied and it remains     unknown if fear induces the coagulation system.The objective was to explore the effects of     acute fear on the coagulation system while sitting still. In a crossover study design healthy     subjects will be exposed to a horrifying e.g. scary movie followed by a dull e.g. flat movie     which is shown at least 1 week after the first movie on the same day of the week at the same     time of the day. Participants will be recruited among students from the Leiden University     Medical Center. Blood will be drawn from the cubital vein 10 minutes before the first movie,     directly after the first movie. The same will be done 10 minutes before and directly after     the second movie. Blood is drawn by using a needle puncture.      Individual markers of coagulation activity will be determined from the blood samples. Pulse     rates will be measured and an anxiety/fear score will be collected from each student for both     movies.   "
52294|NCT02601040|"     The main purpose of this study was to evaluate the safety and immunogenicity of     Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese     people.   "
52295|NCT02601027|"     The purpose of this trial is to determine if using abdominal nerve blocks when patient     undergo breast reconstruction can significantly decrease use of pain medications after     reconstructive surgery.   "
52436|NCT02599181|"     The aim of this study was to investigate the influence of alcoholic skin disin-fection before     PNC (perineural catheter)-removal on the detection of bacteria on the subcutaneous part of     the PNC or on the tip. Furthermore, the correlation of bacterial colonization with     PNC-associated local inflammation or infection was evaluated.   "
52296|NCT02601014|"     This phase II trial studies how well nivolumab and ipilimumab work in treating patients with     hormone-resistant prostate cancer that has spread to other places in the body and express     androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be     resistant to hormone therapy and some chemotherapy in patients with prostate cancer.     Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key     biomarkers or proteins that help tumor cells to escape the immune system surveillance and     this may help the immune system to kill tumor cells that express AR-V7.   "
52297|NCT02601001|"     The purpose of this study is to evaluate the PK, safety and tolerability of omecamtiv     mecarbil in healthy volunteers.   "
52298|NCT02600988|"     The purpose of this study is to determine whether vitamin D is effective in the prevention of     graft-versus-host-disease after completion of allogeneic transplant.   "
52299|NCT02600975|"     This is a clinical trial in which healthy volunteers will be administered an experimental     malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B.      All vaccinations will be administered intramuscularly. Each volunteer will receive three     vaccinations in total.      There are two different vaccine schedules:      Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg     with AS01B on days 0, 28, and 56.      The study will assess the safety of the vaccine, and the immune responses to the vaccination.     Immune responses are measured by tests on blood samples.      Healthy adult volunteers will be recruited in Oxford and Southampton, England.   "
52300|NCT02600962|"     The aim of the study is to investigate the impact of an initial non-specific / non-cardiac     diagnosis on mortality among patients hospitalised with acute myocardial infarction.   "
52301|NCT02600949|"     The goal of this clinical research study is to learn if it is possible to make a vaccine for     advanced pancreatic or colorectal cancer. In this study, you will receive the vaccine in     combination with pembrolizumab. The safety of this vaccine in combination with pembrolizumab     will also be studied.      This study will use your tumor cells (either from a fresh biopsy or from leftover tissue     samples) and blood to help create a vaccine designed specifically for you based on what the     study doctor and research staff can learn about the type of mutated proteins (a type of     genetic change) in the tumor.   "
52303|NCT02600923|"     The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin     American countries before it becomes commercially available to patients with HR     positive/HER2-negative ABC who are appropriate candidates for letrozole therapy.   "
52304|NCT02600910|"     Over 300,000 people in the United States have spinal cord injuries and many use manual     wheelchairs for mobility. Most manual wheelchair users will develop shoulder injuries and     pain that greatly affect quality of life and level of independence. Understanding when     shoulder disease starts in manual wheelchair users and which daily activities contribute to     the disease will provide necessary evidence for effective primary prevention methods to     inhibit the development of further disability. Our central hypothesis is that the development     of shoulder disease in manual wheelchair users will be strongly associated with the     cumulative exposure to elevated shoulder postures combined with high upper body loading.   "
52305|NCT02600897|"     This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment     with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or     refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab     vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL),     followed by post-induction treatment with obinutuzumab in combination with lenalidomide in     participants with FL who achieve a complete response (CR), partial response (PR), or stable     disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus     lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.   "
52306|NCT02600884|"     The purpose of this research study is to evaluate a brief parent-based adolescent sexual     health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an     established intervention called Families Talking Together (FTT) and will enhance FTT by     adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether     FTT will help parents increase sexual health communication, delay adolescent sexual debut,     and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be     delivered by student nurses.   "
52307|NCT02600871|"     The purpose of this study is to determine if the use Provodine as an antiseptic and hand wash     once daily for at least 7 days will have better healing, better health outcomes, fewer     treatment failures and fewer infections themselves and among their household contacts than     those who do not use Provodine.   "
52308|NCT02600858|"     The study determines whether standard medical care (dopamine) affects learning and retention     of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on     the feeding task generalises to performance on an untrained upper limb buttoning task. Half     the participants will train on the feeding task after they have taken their first dose of     dopamine for the day (i.e. on medication state), while the other half will train on the     same feeding task before taking their first daily dose of dopamine (i.e. off medication     state).   "
52309|NCT02600845|"     This post-market, interventional, prospective, single arm, the United States (US) based     multi-center study will assess the change in treatment satisfaction of participants who     utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.   "
52310|NCT02600832|"     The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham     training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female     veterans entering treatment for AUD at the VA Medical Center at San Francisco, California,     between ages 18-65. The study consists of screening, 3-week AABM training, Week-4 post-test,     and Week-12 follow-up. Assessment of inhibitory control, alcohol approach bias and craving     will be administered at baseline and Week-4. Immediately following screening, patients will     be randomly assigned to receive 9 sessions of real or sham AABM training (16 subjects each)     taking place over three weeks. Following the 3 weeks of training, patients will complete a     Week-4 post-test which includes assessment of alcohol approach bias, inhibitory control, and     craving and a Week-12 follow-up assessing drinking behavior.   "
52311|NCT02600819|"     This study will evaluate the safety and tolerability of     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose     combination (FDC) in HIV-1 infected adults with end stage renal disease (ESRD) on chronic     hemodialysis (HD) at Week 48.   "
52312|NCT02600806|"     A clinical protocol was developed for the management of adult outpatients with     community-acquired pneumonia (CAP) and Pneumonia Severity Index risk classes I-II. Patients     are assigned to oral azithromycin or levofloxacin according to procalcitonin (PCT) levels     measured with a rapid point-of-care method. When PCT levels are <0.5 ng/ml, azithromycin, 500     mg/day is given orally for 5 days; if PCT is ≥0.5 ng/ml, levofloxacin, 500 mg/day is given     orally for 7 days   "
52313|NCT02600793|"     Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called     cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults     patient shave shown ceftaroline fosamil to be effective against many bacteria that are     resistant to other currently approved antibiotics. Some of these bacteria may be responsible     for infections in the central nervous system.The main aim of this study is to gather     information to determine how much of a single IV dose of ceftaroline fosamil will enter into     a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections     can be better determined.   "
52314|NCT02600780|"     Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits     antihyperuricemic activity by reducing the formation of uric acid. The investigators     conducted an interventional, two-arm, randomized, open label pilot study on patients with     serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or     Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety     of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.   "
52315|NCT02600767|"     This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of     Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P.     falciparum monoinfection will be treated under supervision with artemether-lumefantrine for     three days, with doses according to the Brazilian guidelines for malaria control. The     clinical and parasitological parameters will be monitored for a 28-day follow-up period to     evaluate the efficacy of the combination therapy. A blood sample will be collected on filter     paper on the first day and on the day of suspected failure to try to differentiate the     parasite genotypes using techniques based on polymerase chain reactions. The results of this     efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to     evaluate the national policy for treatment of malaria caused by P. falciparum.   "
52316|NCT02600754|"     This study aims to find an effective and sustainable approach to reducing disparities in     accessing mental health services for an underserved and growing population group of     low-income, racially diverse, homebound older adults. It will compare two aging-service     integrated, teledelivered depression treatments for these seniors. One model is short-term     problem-solving therapy by licensed clinicians; the second model is self-care management     support by trained lay advisors. The findings are expected to create a foundation of     information for guiding the implementation of acceptable, effective, and sustainable     depression care within widely available aging-service infrastructures.   "
52317|NCT02600741|"     The primary purpose of this study is to evaluate the overall effect of caregivers receiving a     study-provided caregiver psycho-education and skills training program on the number of     treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit,     crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or     suicide attempt) in patients under their care during a 12 month period.   "
52318|NCT02600728|"     Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute     to progressive impairment in gait performance. The use of declarative memory cues in order to     promote the engagement of attention and activation of the next movement in gait may minimize     the consequences of lack of automatic control. The purpose of this study is to verify the     long-term efficiency of a new strategy based on declarative memory cue to improve the gait     performance and independence in daily life activities (DLA) in patients with PD.   "
52319|NCT02600715|"     The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os)     can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder     for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial     cystitis.   "
52320|NCT02600702|"     The purpose of this study is to compare the exercise protocol called Siriraj home base     exercise program for OA knee to usual care and physical modalities for conservative     treatment in patients with 1st OA knee.   "
52513|NCT02598180|"     Vergenix Flowable Gel is indicated for the management of acute and chronic wounds   "
52321|NCT02600689|"     Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention     to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those     individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any type     of maintenance exercise therapy (phase 3). This is largely due to personal factors, such as     access to transportation, weather, scheduling difficulties, and cost.      Little is known about how to enhance physical activity among patients with IPF. In addition,     no studies have investigated the long-term maintenance strategies of physical training in     patients with IPF. Thus, the purpose of this study is to test the feasibility and     effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized,     blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and     cognitive video gaming, with no active whole body movement involved — will be used to     investigate the benefits of a home-based exergame program on improving pulmonary-related     function and symptoms in patients with IPF.   "
52322|NCT02600676|"     This is a randomized, double blind, placebo controlled study of the effect of Sacral     Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic     nocturnal enuresis (MNE).   "
52323|NCT02600663|"     Patients with acute back pain (<6 weeks) presenting at their general practitioner will be     enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will     fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening     Tool. These two questionnaires categorize back pain patients into individuals at risk of     chronic back pain and those not at risk. Furthermore, data concerning pain location,     severity, duration and impairment will be collected. Study participants will receive standard     care treatment prescribed by their general practitioner. Six months later, study participants     will receive a questionnaire in order to collect data concerning their present pain     situation. Patients with relevant impairment in their activities of daily living as a result     of back pain will be categorized as individuals with chronic back pain. Categorization at six     months will be compared with the categorization at presentation.   "
52324|NCT02600650|"     The purpose of this study is to determine whether a proprietary 'testosterone-boosting'     supplement, when used as recommended by the manufacturer, results in an increase in     testosterone levels as measured by a salivary free testosterone assay.   "
52325|NCT02600637|"     Summary: Thousands of Veterans suffer a stroke every year, and these individuals often suffer     emotional and cognitive changes that negatively affect their quality of life as well as their     ability to recover. In addition to traditional rehabilitation such as physical and     occupational therapy, a number of alternative treatments are now being studied for their     ability to enhance patients' recovery following stroke. One of these treatments,     Mindfulness-Based Stress Reduction or MBSR, involves an 8-week course that teaches     individuals strategies such as breathing techniques, meditation, and movement therapy. The     current pilot study proposes to teach MBSR to a group of Veterans with a history of stroke to     determine whether this type of intervention is feasible, acceptable to patients, and shows     preliminary evidence of beneficial effects on psychological and cognitive functioning. The     investigators hope to find that MBSR is a useful, additional intervention that can improve     Veterans' well-being and quality of life as they recover from stroke.   "
52326|NCT02600624|"     The purpose of this study is to examine the association between maternal alcohol use and     newborn phosphatidylethanol (PEth) levels in their newborn.   "
52327|NCT02600611|"     This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim     compared to vancomycin for the treatment of skin and skin structure infections.   "
52328|NCT02600598|"     This is a Phase I, single-centre, open label, within-subject comparison trial to explore the     biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in     patients with actinic keratosis on the upper extremity. The treatment area for each patient     will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including     the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at     least one AK lesion located in a non-treated area on the contralateral arm. All eligible     subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study     medication application will be (sub)investigator applied. A total of 30 patients will be     enrolled into this study (n=15 in each of the two groups). Patients will be divided into two     groups with different biopsy schedules.   "
52329|NCT02600585|"     The primary objective of this study is to retrospectively characterize the safety of Flublok     in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent     inactivated influenza vaccines (IIVs), using a methodological approach designed to query the     database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern     California (KPNC), a large medical care organization (MCO).   "
52330|NCT02600572|"     Determine the changes in attention level due to isometric exercises and level three     progression eccentric movements. The attention level will be measured using a mental speed     test (how quickly a subject can process information and make decisions based upon that     information). Another outcome measure will be the ability of the subject to maintain balance   "
52331|NCT02600559|"     This is an 8-week, multicenter, open-label study in which eligible subjects with a history of     otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is     designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement     with common concurrent surgeries and any middle ear effusion status.   "
52332|NCT02599857|"     Life expectancy of children with congenital heart disease (CHD) has increased dramatically     during the past years, due to the successes of cardiac surgery. Nearly all of these children     with CHD can be operated at young age and more than 90% reach adulthood. However, many adults     with CHD are life-long affected by cardiac events, particularly arrhythmias and heart     failure, putting them at risk of premature death. These events have a large impact on quality     of life of patients and their families and merit life-long hospital visits in a medical     center specialized in adult CHD. Especially for adults with CHD patient care with a     smartphone is suited because of their young age and chronic condition. So far, data are     lacking on smartphone interventions in patients with CHD.   "
52514|NCT02598167|"     This multi-center non-interventional, observational, cross-sectional study in adult     participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the     participants' preferences for disease modifying treatments (DMT) in routine clinical     practice.   "
52333|NCT02599844|"     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly     recognized as a significant factor associated with long-term mortality among different     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in     the development of hypertension and cardiovascular disease. The investigators overall     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,     long-term consequences with regard to kidney function, endothelial function, blood pressure     control, and overall health.   "
52334|NCT02599831|"     The purpose of this study is to determine whether electrical pudendal nerve stimulation is     more effective than pelvic floor muscle training plus transanal electrical stimulation in     treating post prostatectomy Incontinence.   "
52336|NCT02599805|"     Diabetic foot complications care represent a significant burden to the Canadian healthcare     system. The estimated annual expenditure in Canada for diabetic foot ulcers is more than $150     million. A small sized randomized controlled trial (n=17) investigating the use of topical     oxygen therapy (n=9) against placebo (n=8) for diabetic ulcers was done recently and showed a     87% average reduction of ulcer size in treatment group versus 46% average reduction in the     control group (p<0.05).      Despite the standards of care used today in diabetic foot ulcer treatment, wounds may be     non-healing when they do not heal within the appropriate time frame expected by an     experienced clinician. Current diabetic foot ulcer standards of care include: full medical     assessment in all cases, surgical intervention where indicated and local treatment of the     ulcer.      Given the scarcity of controlled trials specifically designed to review the effects of     topical oxygen in ulcer care, this study will contribute to the understanding of the     management of these ulcers by assessing the reductions in ulcer size achieved using Natrox™     topical oxygen therapy.   "
52337|NCT02600546|"     Evaluate the repeatability and reproducibility of the RTVue-XR for measuring the total     corneal thickness (pachymetry), the epithelial thickness, and the stromal thickness mapping     in normal subjects and corneal patients.   "
52338|NCT02600533|"     This study will measure the effects of an office-based, clinical trial education video on     clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no     previous history of clinical trial participation. This study will also determine the     feasibility of implementing an office-based video educational program.   "
52339|NCT02600520|"     The present study is designed as a single-centre, randomized, controlled clinical trial to     evaluate and compare the clinical and radiographic efficacy of two local drug delivery     systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in     patients with chronic periodontitis as an adjunct to SRP.   "
52340|NCT02600507|"     The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate     in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in     patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.   "
52341|NCT02600494|"     The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,     parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I     or Bipolar II disorder having a major depressive episode.   "
52342|NCT02600481|"     This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have     different impacts on troponin T（TnT) level as well as pulmonary complications after prolonged     robot-assisted surgeries in the Trendelenburg position.   "
52343|NCT02600468|"     The purpose of this study to collect information on the safety, especially serious infections     and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in     patients with rheumatoid arthritis.   "
52344|NCT02600455|"     The purpose of this study to collect information on the safety, especially localized     injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in     patients with rheumatoid arthritis.   "
52345|NCT02600442|"     A correlation between early changes in the tumor maximum standardized uptake value (SUVmax)     on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological     response after 6 to 8 cycles has been demonstrated in several independent small series of     patients.      Breast tumor proliferation status has previously been demonstrated to be a good predictive     factor of response to chemotherapy. The best method for assessing proliferation status is     unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay     for comparing the proliferation status between tumors. However major variations in analytical     procedure and interpretation limited its clinical value. Taking into account the prognosis     and predictive value of proliferation gene as a common signature in breast cancer     transcriptome analysis, quantitative assessment of mRNA expression of genes involved in     proliferation has been developed by the investigators team and others. The evaluation of     these parameters is quantitative and reliable and can be standardized for a clinical use.      The main objective of the investigators study is to early predict pathological response to     anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based on     FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of     proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry     and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of     the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).   "
52346|NCT02600429|"     The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic     Solution compared to placebo for the treatment of NK.   "
52347|NCT02600416|"     The aim of this study is to determine the effects of AV port reversal (AVPR) on     recirculation, clearance, post-filter ionized calcium and subsequently citrate dosing.   "
52348|NCT02600403|"     The aim of this study was to evaluate structural and functional improvement following     intraocular pressure (IOP) reductions in patients with glaucoma using Spectral Domain Optical     Coherence Tomography (SD-OCT), Visual Field (VF) testing, and Visual Evoked Potential (VEP).   "
52349|NCT02600390|"     SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.   "
52516|NCT02598141|"     The main objective of this study was to compare the diagnostic capability (sensitivity and     specificity) of standard bacteriological analysis made from one or other of the two sampling     processing techniques and perioperative management of samples : the Ultra Turrax method that     uses grinding versus the standard method.   "
52350|NCT02600377|"     Vegetarian and vegan diets have been shown to reduce chronic disease risk, including diabetes     and cardiovascular disease, as well as several cardiometabolic risk factors. Whether     vegetarian and/or vegan dietary patterns improve cardiometabolic risk factors in individuals     with diabetes remains unclear. To address the uncertainties, the investigators propose to     conduct a series of systematic reviews and meta-analyses of the totality of the evidence from     randomized controlled trials to distinguish the effect of vegetarian and/or vegan diets on     the prevention and management of diabetes. The findings generated by this proposed knowledge     synthesis will help improve the health of consumers through informing evidence-based     guidelines and improving health outcomes by educating healthcare providers and patients,     stimulating industry innovation, and guiding future research design   "
52351|NCT02600364|"     The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation     Device.   "
52352|NCT02600351|"     This study will evaluate the efficacy, safety and tolerability of ledipasvir/sofosbuvir     (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in     participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24     weeks without RBV in participants with cirrhosis.   "
52353|NCT02600338|"     Legumes are generally recognized as healthy dietary components, and although beans and     legumes are recommended in food guidelines in North America, guidelines vary in regards to     how much and how often these foods should be consumed. Furthermore, although North American     and European guidelines recommend dietary pulses for glycemic control, dietary pulses and     other legumes are not specifically suggested for controlling blood pressure and maintaining     heart health. To improve evidence-based guidance for legume recommendations, the     investigators propose to conduct a systematic review of clinical studies to assess the effect     of eating legumes in exchange for other foods on blood pressure in humans. The systematic     review process allows the combining of the results from many small studies in order to arrive     at a pooled estimate, similar to a weighted average, of the true effect. The investigators     will be able to explore whether eating legumes has different effects in different     demographics, and whether or not the effect of legumes depends on how much/often they are     eaten. The findings of this proposed knowledge synthesis will help improve the health of     Canadians through informing recommendations for the general public, as well as those at risk     of heart disease and diabetes.   "
52354|NCT02600325|"     New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure     95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir     (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA     approved combination DAA therapy.      It is likely that the synergistic effect of the host's immune response and antiviral therapy     when given during the first 6 months of HCV infection makes antiviral therapy during acute     HCV infection more effective. In this study the investigators would like to document that     treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can     ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss     in efficacy.      Study design and intervention:      Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4     patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily     combination tablet).      Study population:      80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV     treatment centers in the Netherlands and Belgium will be included.      Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT     study population (=genotype 1 and 4).   "
52355|NCT02600312|"     The Oxiris® filter is a registered product for CRRT already safely used in routine care.      In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and     cytokines. Compared to conventional filters this may be advantageous in patients with severe     sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has     been demonstrated with clinical use.      But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter     will be investigated in a double blind randomized crossover setting against a traditional     filter (ST150). Either filter will be used for 24 hours after which it will be changed to the     opposite filter for another 24 hours.      Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the     start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10     (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode     and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory     support and pathogen will be registered.      Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired     t-test on AUC values for each 24-hour period.   "
52356|NCT02600299|"     As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported     outcomes and survivorship issues. In view of the numerous medication and psychosocial issues     that are commonly faced by early-stage breast cancer survivors, it deems important to develop     and conduct specific interventional programs to mitigate these problems. In the literature,     it is well recognized that psychosocial interventions are effective to manage emotional     distress and quality of life, with the evidence clearly clustered in studies on female     patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions     including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training     can produce positive effects on emotional distress, anxiety and depression, and     health-related QOL.      The investigators hypothesize that a significant reduction in anxiety, improvement of     cognition and improvement of health-related quality of life among those who receive     psycho-education, in comparison to those in the usual care. Hence, this randomized trial is     designed to assess the effectiveness of a psycho-educational group (PEG) intervention on     supportive care and survivorship issues, which include anxiety, depression, cognitive     function, toxicities management of cancer- or treatment- related physical symptoms, and     health-related quality of life in early-stage breast cancer patients.   "
52396|NCT02599714|"     This dose finding/extension study consists of three parts: Part A will identify the MTD of     the AZD2014/palbociclib combination on a background of fulvestrant (referred to as the     triplet) in postmenopausal women with locally advanced/metastatic estrogen receptor positive     (ER+) breast cancer. Part B will further characterize safety, tolerability, PK, and     preliminary efficacy in single-arm dose expansion groups. Part C will investigate the     efficacy of the triplet combination in a double-blind, placebo-controlled, stratified,     parallel group extension.   "
52357|NCT02600286|"     The disease Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common inherited     peripheral neuropathy, for which no treatment has proved its effectiveness. It is autosomal     dominant, associated with a duplication of the chromosome 17p11.2 region which leads to     overexpression of the gene and the protein-peripheral myelin protein-22 (PMP22), a major     component of peripheral myelin.      In animals and humans, PMP22 mRNA level of glutathione S-transferase theta 2 and Cathepsin A     (markers of oxidative stress), detected in a skin biopsy are markers that may play a role in     the prognosis evolution of the disease. Furthermore, several studies have shown that the     administration of progesterone increased the expression of PMP22 gene (measured in a skin     biopsy) and worsening symptoms. In contrast, anti-progestins reduce the synthesis of PMP22     and improve symptoms in rat CMT1A.      The long-term safety of anti-progesterone was evaluated for mifepristone (RU486) ulipristal     acetate and (EllaOne®). Few side effects have been reported including a few cases of     endometrial hyperplasia reversible upon discontinuation of treatment. With the RU486, rare     cases of adrenal androgen and failure have been observed. However, EllaOne® has low     antagonistic action on the glucocorticoid receptor and no action on androgen receptors. The     investigators therefore believe that it will be well tolerated in humans and will reduce the     synthesis of PMP22 and the action of oxidative stress by improving disability of patients.   "
52358|NCT02600273|"     The purpose of this study is to assess initial reactions to alternative nicotine/tobacco     products among smokers living with HIV.   "
52359|NCT02600260|"     Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of     these patients. The application of a protocol for assessing the risk of VTE reduces mortality     and morbidity of these phenomena.   "
52360|NCT02600247|"     This study aims to compare the effectiveness of duloxetine after total knee arthroplasty in     Central sensitization patient. Central sensitization plays an important role in the chronic     pain experienced by osteoarthritis patients.Elimination of the nociceptive input from the     damaged joint by total joint arthroplasty was not always followed by a complete resolution of     symptoms. Patients with high levels of preoperative pain and low pain thresholds had a higher     risk of persistent pain after total knee arthroplasty (TKA), which has been interpreted as     evidence of central sensitization. Thus, the presence of central sensitization before surgery     in Osteoarthritis patients may be an important contributing factor to postoperative pain     versus adequate analgesia. Preclinical models of central sensitization suggest that     duloxetine is effective in the treatment of persistent pain. Investigators will compare the     pain following TKA of central sensitization patients in duloxetine group (n=50) with those in     non-duloxetine group (n=84). Investigators will classify the central sensitization patients     by central sensitization inventory and divide the central sensitization patients in to 2     groups (duloxetine and non-duloxetine group) randomly. Investigators checks the visual     assessment scale at preoperative, postoperative 1, 2,6,12 weeks. All participants will     receive postoperative pain control after TKA using the same pain control regimen except     duloxetine.   "
52361|NCT02600234|"     A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial     Pressure in Patients with Heart Failure.   "
52362|NCT02600221|"     To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with     chronic airflow limitation in China.   "
52363|NCT02600208|"     This is a single arm pilot study for patients with hematologic malignancies with alternative     donor sources receiving unrelated or partially matched related/Haploidentical mobilized     peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus     CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one     year leukemia free survival.   "
52364|NCT02600195|"     This 4-year cluster randomized controlled trial aims to determine whether implementation of     Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired     infection in Chinese Neonatal Intensive Care Units (NICUs).   "
52365|NCT02600182|"     The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure     (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients     undergoing cardiac surgery at the University Hospital of Santa Maria.   "
52366|NCT02600169|"     This study is a retrospective cohort study. A database will be created from the data     available of all patients that have participate in the named patient program for     pembrolizumab in the Netherlands. This database will be used for analysis of response markers     and for an evaluation of adverse events.   "
52367|NCT02600156|"     The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided     focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk     native prostate cancer.   "
52368|NCT02600143|"     The aim of this trial is to identify biomarkers and genetic predisposition for the     development of immune checkpoint related colitis.   "
52369|NCT02600130|"     This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study designed     to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for the     treatment of subjects with clinically diagnosed Alzheimer's disease.   "
52370|NCT02600117|"     Recent evidence suggests that patients with inactive chronic hepatitis B (CHB) may develop     the same types of liver complications that patients in the active state of hepatitis B virus     (HBV) infection experience. Treatment guidelines for patients in the active state of HBV     infection indicate that HBsAg clearance is associated with definitive remission of the     activity of chronic HBV & improved long-term outcome. Clinical data showed that HBsAg     clearance is achievable, in a small population of patients on continuous treatment with     potent oral antivirals (OAVs), such as tenofovir disoproxil fumarate (TDF). It is possible     the same OAVs can have the same effect in patients with inactive CHB, but in a shorter     treatment duration. The purpose of this study is to find out if TDF is effective in     controlling HBV DNA & promoting seroconversion from HBsAg-positive to HBsAb-positive in     patients with inactive CHB.   "
52371|NCT02600104|"     Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles     Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5     investigational sites.   "
53776|NCT02581696|"     An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction     and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers   "
52372|NCT02600091|"     Type 1 and 2 diabetes are challenging conditions to manage. Anxiety and depression are common     among this group and are associated with poorer diabetes control. No trials have been     conducted to ascertain the effectiveness of psychological interventions designed to alleviate     significant levels of anxiety and/or depression and improve glycaemic control among those     with diabetes who have significant difficulties with their emotional wellbeing and diabetes     control.      The aim of this project is to establish if it is feasible to run a multi-site randomised     controlled trial in Scotland exploring whether an 8-week mindfulness and self-management     based intervention programme decreases anxiety and/or depression, and improves diabetes     control. This feasibility study, based on the MRC framework for assessing feasibility and     piloting methods, will assess the relative strengths and weaknesses of the intervention and     study design, and pave the way for a larger and definitive trial.   "
52373|NCT02600078|"     With exposure to high altitude some individuals will develop acute mountain sickness (AMS).     Current evaluation of AMS can make it difficult to rule out other possible conditions.     Evaluation of ataxia, as measured by the performance of a coordinated task, can aide in the     correct diagnosis of AMS. The investigators have developed novel finger-tapping tasks on a     mobile device to assess both reaction time and accuracy. The proposed research will evaluate     the utility of this tool in assessing human acclimatization to hypoxia.   "
52374|NCT02600065|"     Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases.     Neurological decline is observed in these patients and tumor progression or radiotherapy side     effects have been made responsible for this. However CMV encephalitis may also be a reason.     Therefore the investigators aim to analyze the CMV status in patients during and after     radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and     IgM ELISA) in the blood of the patients. These findings will be correlated with changes in     the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral     blood will be performed.   "
52375|NCT02600052|"     INTRODUCTION:      Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as     bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the overall     PD patients, mostly there is associated respiratory disorders. The respiratory impairment may     be due by postural changes, limiting the flexibility and expandability of the chest wall     causing decreased lung volumes and flows. So the exercise Proprioceptive Neuromuscular     Facilitation (PNF) is a tool designed to reduce the changes in respiratory function, the     commitment of the respiratory muscles, and allows greater flexibility of the chest wall,     reducing the rigidity of the rib cage. To evaluate the effects of respiratory pattern of     Proprioceptive Neuromuscular Facilitation on the distribution of pulmonary ventilation,     compartmental volumes of diaphragmatic mobility and functional capacity in patients with     Parkinson's disease.      METHODS:      The study is a clinical trial randomized, in which participants to be elected for the study     should present diagnosis of PD, staging of disease between II and III according to Hoehn and     Yahr. Initially, the participants will undergo the collection of data on medical history,     assessment of pulmonary function by spirometry and respiratory muscle strength measured by     the manometer. Then will undergo evaluation of the breathing pattern and tricompartmental     distribution of the volume of the chest wall by hemithorax by Plethysmography Optoelectronic;     Quantify the mobility of the right diaphragm in total lung capacity for maneuver and during     the current volume by ultrasonography. After the evaluation, participants will undergo     intervention which will consist of three stages: first occur first session of the PNF later     aerobic training for 30 minutes, ending with one PNF session.   "
52376|NCT02600039|"     Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory     therapy is always recommended to the CF patient with pulmonary involvement and has differents     techniques and devices, however, there is no consensus on the effectiveness of the techniques     used, there is a need to determine the applicability of the therapeutic resources used.     Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on     Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by     Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial     randomized crossover. Volunteers will be included with FC with moderate to severe lung     disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations in     the last four weeks or during the study period; cor pulmonale; facial deformity that causes     air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in     the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis;     hemodynamic instability and do not understand the use and command of the techniques used. The     sample is selected by convenience from the database of individuals assisted data in     Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be     developed in three phases, divided into three days with an interval of at least 48 hours     between phases. The first day will undergo initial assessment and in the days following the     intervention by day, ELTGOL or Acapella, in a randomized order.   "
52377|NCT02600026|"     This study will use an in-car monitoring system supplemented with video feedback to reduce     the number of unsafe driving behaviors. If successful, this technology will provide a means     to enhance public safety on the roads that could be adopted immediately in this at-risk group     of drivers. The intervention will also maximize the time for independent driving, improving     the overall quality of life of these individuals.   "
52378|NCT02600013|"     The aim of this observational, non-controlled, non-profit study is to describe the responses     to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete     motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient     intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the     device are also assessed and described.   "
52397|NCT02599701|"     The primary objective of this study is to evaluate the effects of gabapentin in sleep     polysomnography parameters and in nocturnal secretion of endogenous     hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic     axes hormones and basal IGF-1 in older men.   "
52398|NCT02599688|"     This is an open-label, observational extension of patients who received POLAT-001 in     LipoLat-CS202.   "
52399|NCT02599675|"     This study evaluates the effect of vitamin D supplementation on outcomes muscle performance     and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be     allocated to ingest either vitamin D (35) or placebo (35) in a double-blinded fashion   "
52379|NCT02600000|"     Heart failure (HF) is configured major problem for public health in the country. Affected     individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of     the sympathetic myocardial activity, among others. In relation to the treatment of patients     with heart failure with symptoms mentioned above a great alternative is the implantation of     cardiac rehabilitation programs, these programs can also be associated with other muscle     training measures, among these there is inspiratory muscle training (IMT), as the weakness of     these muscles is rather found in this population and this directly related to signs and     symptoms. OBJECTIVE: To evaluate the efficacy of inspiratory muscle training associated with     a cardiac rehabilitation program in the modulation of sympathetic myocardial activity and     maximal and submaximal functional capacity of patients with HF between 21-60 years.     METHODOLOGY: This is a clinical trial, controlled, randomized, double-blind being developed     in partnership with the Department of Physical Therapy, Federal University of Pernambuco     (UFPE) and the Hospital das Clinicas (HC) of Pernambuco, whose patients will be accrued on     the Recife's main referral centers in caring for patients with heart failure. Patients will     undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and     digital Manovacuometry) as well as on the functional capacity (Ergospirometry), cardiac     innervation (myocardial scintigraphy), mobility and diaphragm thickness (ultrasound) and     quality of life. After the evaluation will be randomly allocated into two groups: The control     group will perform cardiac rehabilitation associated with the Sham of IMT, and the     experimental group cardiac rehabilitation associated with the IMT at 30% of maximal     inspiratory pressure. The intervention will last three months for both groups and after this     phase patients will be submitted again to the assessment tools. EXPECTED RESULTS: To clarify     the association between physical exercise associated with specific respiratory training in     modulating the autonomic nervous system of patients with HF and what the relationship with     reflected cardiorespiratory fitness in maximal and submaximal functional capacity.   "
52380|NCT02599987|"     Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion     capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the     respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy.     The inspiratory muscle training (IMT) appears as an instrument to improve the inspiratory     muscle strength, with positive effects on functional capacity and quality of life of kidney     patients, however, the effects of IMT were not addressed in the specific variables of the     respiratory system and to date there are no studies on the use of daily training in this     population. Objective: To evaluate the effectiveness of daily inspiratory muscle training on     respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage     renal disease patients. Methods: A randomized controlled clinical trial to be developed in     Cardiopulmonary Physical Therapy Laboratory of the Universidade Federal de Pernambuco (UFPE)     during the period from November 2015 to December 2016. The sample is composed of 24     individuals aged 18 and 65, having CKD, to perform hemodialysis for at least twelve months     and provide inspiratory muscle weakness. Patients will be divided into two groups, the     training group will be IMT with POWER-breathe®, load of 50% of MIP, duration of three sets of     30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham     group will be subjected to the same procedure (duration and frequency), but without load.     Participants will be assessed before and after intervention through a global assessment form,     questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF, diaphragmatic     ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.   "
52381|NCT02599974|"     The two main objectives of this prospective study are:        -  to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron          emission tomography) CT-scan (Computed tomography scan) provides useful information for          the treatment of breast cancer (ASAINT 1),        -  to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant          therapy early, in M0-patients (ASAINT 2).      The secondary objective is to better understand the interactions between the imaging     parameters of FDG PET-CT-scan and biological and histological features of breast cancer .      This is a non-interventional study. Two PET-CT-scans are performed, one before starting     treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are     prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in     Paris, France. Oncologists provide clear information to the patients on the purpose of the     examination. The examinations are performed in the nuclear medicine department at St. Louis     hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological     tests, results of surgery and patient's follow-up are summarized in a de-identified file.     This file has been declared to the National Commission on Informatics and Liberties (CNIL).     The data in this file are established prospectively and secondary analyzed to assess the     precise role of PET-CT-scans in the initial staging of breast cancer and to determine the     optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.   "
52382|NCT02599961|"     UX007G-CL202 is an open-label, single-arm, multi center extension study to assess the     long-term safety and efficacy of UX007 in Glut 1 DS. The study will enroll up to 40     pediatric, adolescent and adult Glut 1 DS subjects who have completed the UX007G-CL201 study     or participated in qualified ISTs.   "
52383|NCT02599948|"     Assessment of nutritional practices in french intensive care units.   "
52384|NCT02599935|"     To assess the effect over the nutritional status in patients who are malnourished with     chronic heart failure, of an educational intervention and the provision of nutritional     supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months   "
52385|NCT02599922|"     This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of     rAAV2tYF-PR1.7-hCNGB3 administered to one eye by subretinal injection in individuals with     achromatopsia caused by mutations in the CNGB3 gene. The primary study endpoint will be     safety and the secondary study endpoint will be efficacy.   "
52386|NCT02599909|"     Background:      There are about 100 trillion microbial cells in a person s gut. This is called the human gut     microbiota. When this is disrupted, it can lead to many diseases. Studies show that the gut     microbiota in people with cancer is different than that found in healthy people. Researchers     want to study links between the gut microbiota and the immune system in people with a liver     disease called hepatocellular carcinoma (HCC).      Objective:      To study links between gut microbiota and the immune system in people with HCC.      Eligibility:      People at least 18 years old with HCC. They must be scheduled to have tumors removed by     surgery.      Design:        -  People having surgery for primary liver tumors at the Mount Sinai Medical Center will be          screened for this study.        -  At the initial visit, blood, rectal swabs, urine, and stool will be collected.          Participants will answer questions about their medical condition.        -  Before surgery, blood, rectal swabs, urine, and stool will be collected. This will be          done at a routine visit.        -  When they have surgery, a piece of liver tissue with the tumor will be collected. This          will be sent to the National Cancer Institute for tests.        -  After surgery, blood, rectal swabs, urine, and stool will be collected 3 times. This          will be done at routine visits.   "
52387|NCT02599896|"     Background:      Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus.     HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses.     Researchers want to see if it does this in people.      Objectives:      To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is     maintained in people and if they develop an immune response to it.      Eligibility:      Healthy people ages 18 to 50      Design:      Participants will be screened in protocol number VRC 500 (NIH 11-I-0164) with medical     history, physical exam, and blood and urine tests.      The study will last 24 to 48 weeks. Visits will last 2 to 8 hours.      Participants will get VRC01LS through either:        -  A needle in an arm vein or        -  A small needle placed into the fatty tissue under the skin of the abdomen, thigh, or          arm.      Participants will be assigned to 1 of 6 groups.      Groups 1 to 4 will get 1 dose of VRC01LS. They will have follow-up visits through week 24.      Groups 5 and 6 will get 1 dose of VRC01LS every 12 weeks (3 doses). They will have 4 to 5     visits between the second and third dose, and follow-up visits through week 48.      Participants will have 1 to 3 follow-up visits in the week after receiving VRC01LS. They will     record their temperature and keep a diary of symptoms for 3 days after a dose. They may have     additional unscheduled visits.      At each visit, participants will have a physical exam and may have blood and urine tests.   "
52388|NCT02599883|"     Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of     chronic morbidity and mortality worldwide. There is debate about diagnosis and management of     COPD because it was described as complex syndrome accounting for various pulmonary and     extrapulmonary abnormalities. As a result, there is consensus that both clinical evaluation     and pulmonary function tests (PFTs) data by themselves do not adequately describe the     complexity of the disease. The chest radiograph is the sole imaging examination recommended     for the routine evaluation of these patients by the physicians guidelines (GOLD     guidelines),which, however, are also debating on the utility of computed tomography (CT) in     this setting. Indeed, a number of studies reported a dramatic increasing use of CT of the     chest for COPD assessment, in both clinical and research settings. COPD assessment by CT     seems to improve the accuracy and completeness of the clinical evaluation of these patients.     Nevertheless, the clinical utility of CT has yet to be proved by prospective studies or     defined by guidelines.      Objectives: To evaluate the change in the diagnosis and management of COPD when multiple     CT-derived information is added to pre-test evaluation.      Methods: Four pulmonologists with various expertise in the field will review clinical data,     PFTs results, and chest radiographs of 200 consecutive COPD patients diagnosed according to     current guidelines. Therefore, after two months from the first evaluation, the pulmonologists     will review the clinical and PFTs records with comprehensive information about low-dose CT     (LDCT) previously performed in a week from the chest radiograph. Information about LDCT     findings will include qualitative assessment by an experienced chest radiologist and     quantitative analysis by means of an innovative 3D imaging dedicated software. Phenotype     assessment and patient care decisions (e.g. therapeutic and follow-up strategies, need of     additional tests etc.) will be recorded before and after assimilation of LDCT data.      Expected results: This evidence-based prospective study will test the impact of chest LDCT on     management of COPD patient. In addition, the level of agreement between pulmonologists in     terms of diagnosis and therapeutic strategies will be assessed. Furthermore, the study will     evaluate the need for additional tests referable to LDCT information and their impact on the     health care system (e.g. in terms of additional costs).   "
52389|NCT02599870|"     The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment     when implemented into the pre-operative process for patients undergoing an elective spinal     surgical procedure and requiring post-operative acute pain management, as compared to a group     of subjects with the same attributes without the guidance of PGx testing for their     post-surgery pain management. This study will also evaluate whether PGx testing can reduce     narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits     and costs.   "
52390|NCT02599792|"     Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and     multiple-ascending doses of CTP-656 dosed for 7 days.   "
52391|NCT02599779|"     This study is designed as a phase-II proof of concept trial to investigate if a treatment     strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is     sufficiently active to warrant further investigation in randomized phase II or III studies.     Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more     likely to have larger more aggressive tumours and reduced survival and renal tumours that     express PD-L1 are more aggressive with poorer outcome. Blocking this receptor/ligand     interaction with monoclonal antibodies can restore the activity of tumour specific T-cells     within the tumour with durable responses documented in early clinical trials in several     tumour types including renal cell carcinoma. The study drug pembrolizumab is designed to     directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be     given to the 1-3 most clinically significant lesions at the time of progression on     pembrolizumab or at the 2nd course of pembrolizumab treatment in an effort to improve the     activity of pembrolizumab. A total of 35 patients refractory to the approved first line     therapy with a targeted drug (Sunitinib or Pazopanib) will be enrolled on study. This group     of patient has a poor outcome on any other 2nd line therapy and urgently need novel therapy.   "
52392|NCT02599766|"     The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial     effects on patients with brain injuries. This study investigates the short-term     biopsychosocial effects that occur when animals are present during therapy sessions in     comparison to therapy sessions without animals, observing a group of 25 patients over 24     therapy sessions. While half of the sessions are held in presence of an animal and half     without, they are as comparable as possible with respect to content and setting. In this     study, patients who are in a slightly advanced rehabilitation process, assessed via their     function profile, are investigated.   "
52393|NCT02599753|"     The objective of this protocol is to investigate the microstructural alterations and     monoaminergic function in Parkinson's disease patients with impulse control disorders and     cognitive impairment by multimodal MRI and 18F-DTBZ PET imaging.   "
52394|NCT02599740|"     This study is designed to test bioequivalence of a assumed key active compound vs. natural     fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood     glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for     assumed key active compound vs. natural extract falls between 0.8 - 1.25.   "
52395|NCT02599727|"     Determine the effects repeated isometric exercises have on balance, blood pressure, heart     rate and pulse ox. Another outcome measure will be a mental speed test (how quickly a subject     can process information and make decisions based upon that information).   "
52430|NCT02599259|"     AiCure uses artificial intelligence and visual recognition technology to confirm medication     ingestion. The software is available as an app and downloaded onto a smart phone. The     single-site, parallel-arm, randomized controlled trial will test the feasibility and impact     of using the platform in a stroke population. End points: usability, consistent use of the     device, and optimization of treatment.   "
52400|NCT02599662|"     Currently, for patients with pancreatic cancer the standard treatment is surgery followed by     chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery     and treat the area of the tumor with intraoperative radiotherapy in one procedure.     Intraoperative radiation delivers low energy x-rays to a targeted area during the time of     tumor removal.      The purpose of this study is to learn about both the good and bad effects of adding     intraoperative radiation therapy. Another goal is to determine and compare the quality of     life before and after the procedure. We will also monitor the effect of the therapy on the     cancer lesion and any complications that may result.   "
52401|NCT02599649|"     The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab),     alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of     these drug combinations will also be studied.   "
52402|NCT02599636|"     Many factors before and after ICU stay determine the outcome of patients at ICU discharge,     the type of illness, physical dependence and other sequelae can be a trigger for     complications in hospital ward which can induce ICU readmission and worse outcome. The     quality of medical assistance during all the hospitalisation should be guaranteed and many     complications or fatal events could be avoidable.      The objective of the present study is to demonstrate that collaboration between the     intensivist and other medical teams in ward can reduce ICU readmission and hospital mortality     after ICU discharge.   "
52403|NCT02599623|"     This prospective randomized is designed to evaluate the safety and efficacy of hernia repairs     using local anesthesia compared with those using general anesthesia for patients with     incarcerated hernia.   "
52404|NCT02599610|"     Digital vaginal examination is the most common method for assessing progress of labor and     delivery. Considering it is the most common intervention women receive during course of     labor, evidence for psychological effects of digital vaginal examination on women is     surprisingly sparse. Reducing the number of vaginal examination during labor has been     proposed by many authors as benefit of more vaginal examination is unclear. However this is     unlikely to happen until more research on the topic demonstrates clear detrimental effects of     vaginal examination.      Our study is aimed at investigating association of vaginal examination with psychological     distress of women during labor. Anxiety during labor is associated with longer labor     duration, increased perception of pain, problems with newborn attachment, and increased rates     of postpartum depression and post-traumatic stress disorder. In this study, women were     assigned to either digital vaginal examination or transperineal ultrasound assessment groups     were compared to each other in a randomised controlled setting.   "
52405|NCT02599597|"     Depression treatments including physical activity and sleep management has been shown to     relieve depressive symptoms among participants suffering depressive episodes. This study     evaluates the potential of these methods as prevention of depressive relapse or recurrence   "
52406|NCT02599584|"     Simulated environment allowed safe learning of critical events and knowledge of appropriate     response and treatment. Anesthesiology resident education curriculum in Lyon plans several     high fidelity simulation session with a large panel of critical events. Anticipation of     critical events before they may occur and plannification of team resources and priority in     the treatment strategy may help to improve team performance during the scenario. The     investigators' goal is to compare team performance during the scenario with or without a     liberal preparation team staff of 4 min, suggested after the briefing of the scenario but     before the scenario starts.   "
52407|NCT02599571|"     The purpose of this study is to investigate the impact of different nicotine levels in     cigarettes with individuals who have ADHD.   "
52408|NCT02599558|"     This study is being done to see if the investigators can use only the cytosponge ( A 10     minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies     routinely perform during dietary restriction and food reintroduction in EoE?   "
52409|NCT02599545|"     Very low birth weight (VLBW) infants have more health and developmental problems than normal     birth weight full-term infants. These problems are more common in males than female VLBW     preterm infants. Male VLBW infants also experience less positive mother-infant interactions     than females, especially when mothers are emotionally distressed. This is a significant     problem because positive mother-infant interactions function as an important protective     factor against the negative health and developmental outcomes associated with prematurity.     The source of the vulnerability of male VLBW infants to health problems, suboptimal     mother-infant interactions, and poor development goes beyond gender socialization differences     and includes biological factors. Identification of infant and maternal biological     markers/predictors of infant health and developmental outcomes could ultimately lead to     interventions for VLBW preterm infants.      The purpose of this study is to confirm that testosterone rather than cortisol is a more     reliable marker/predictor of complications affecting infants' health outcomes, mother-infant     interactions, and infant cognitive/motor/language developmental outcomes; and that male     infants exhibit a higher sensitivity to testosterone levels than female infants.      This longitudinal study will examine the associations of the steroid hormones, testosterone     and cortisol, levels with infant health, mother-infant interactions, and infant     cognitive/motor/language development ('infant development') in very low birthweight (VLBW, BW     < 1,500 g) preterm (gestational age < 32 weeks gestation) infants after adjusting for     maternal physical and mental health state, infant socioemotional and behavioral development,     and characteristics of infants and mothers. Concurrent and repeated measurement of     testosterone and cortisol levels both in infants and mothers will be conducted through     infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months corrected     age).   "
52410|NCT02599532|"     The nephrotic syndrome (NS) is characterized by proteinuria and hypoalbuminemia, and patients     with nephrotic syndrome are known to be hypercoaguable with increased incidence of venous     thromboembolism necessitating anticoagulation. While classically warfarin has been used as an     anticoagulant in NS, newer oral anticoagulants, such as apixaban, are increasingly used to     treat venous thromboembolism (VTE) in the general population. It is unknown how     hypoalbuminemia and proteinuria affect the pharmacokinetics and pharmacodynamics of apixaban.     This study is to investigate the pharmacokinetics and pharmacodynamics of apixaban in     nephrotic syndrome.   "
52411|NCT02599506|"     This pilot study concentrates on studying the trajectory of breast cancer patient's fear of     recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings     of 100 breast cancer patient's FoR over the course of their treatment. It is hypothesized     that cancer patient's FoR level will rise on nearing the termination of the in radiotherapy     treatment, and radiotherapist-patient interaction modifies the development of patient's FoR.   "
52431|NCT02599246|"     The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2     with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.   "
52432|NCT02599233|"     The main objective of this study is to establish the postoperative pain pathways observed     from D1 to D7 in the context of the current management after orthopedic, digestive,     obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.   "
52412|NCT02599493|"     Rifampicin is an antibiotic usually required to treat susceptible Staphylococcus spp.     osteo-articular infections, most frequently in association with a fluoroquinolone when the     strain is susceptible to both agents. It is the reference treatment for orthopedic infections     with implanted material.      For tuberculosis treatment the dosage of 10 mg/kg/j is usually prescribed, while in the     treatment of Staphylococcus spp. infections the highest dosage of 20 mg/kg/j is proposed by     French experts' recommendations from 2009.      However, there is little evidence in the literature, which could set out arguments to choose     the best dosage of rifampicin, which may vary from 5 to 20 mg/kg.      The issue with rifampicin is side effects, in particular with long-term treatment. Many side     effects may occur in 10 to 20% of patients and sometimes leads to dosage reduction or     treatment interruption.      In the literature, there is little evidence that higher rifampicin dosage is associated with     higher frequency of adverse effects. Depending on the nature of the toxicity, one could say     that hypersensitivity could be independent from dosage, when digestive disorders may be     related. Plasmatic concentrations studies have not given strong arguments to link higher     rifampicin dosages with side effects occurrence rates. After oral absorption, plasmatic peak     occurs after two to five hours and varies among individuals but also in the same patient     overtime. This particular pharmacokinetic profile could explain discrepancy in adverse events     (AEs) frequencies.   "
52413|NCT02599480|"     This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the     prevention of heart failure. This is a two armed, prospective, randomized,     placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron     distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling     with or without symptoms of heart failure (maximum NYHA II).      Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI)     and/or changes in diastolic function (assessed by echocardiography) after 12 months of     treatment.   "
52414|NCT02599467|"     Upper limb neural mechanosensitivity is a painful disturbance that breast cancer patients     often undergo following axillary surgery. It is assessed by the upper limb neurodynamic test     for the median nerve, called upper limb neurodynamic test 1 (ULNT1). Design: A matched     case-control observational study. Objective: to check the increased upper limb     mechanosensitivity by shoulder range of motion (ROM) during ULNT1 and to determine, for the     first time, the evoked electromyographic (EMG) muscle activity. Participants: 62 cases who     underwent breast cancer surgery and 64 matched control women. Setting: Torrejon Hospital,     Physical Therapy Department, Madrid (Spain). Intervention: To record EMG muscle activity     during ULNT1 performance and to measure shoulder ROM. Key outcomes: mechanosensitivity,     breast cancer, pain, EMG, shoulder ROM, median nerve.   "
52415|NCT02599454|"     This phase I trial studies the side effects and best dose of atezolizumab that can be given     together with stereotactic body radiation therapy in treating patients with stage I non-small     cell lung cancer that cannot be removed by surgery. Monoclonal antibodies, such as     atezolizumab, may interfere with the ability of tumor cells to grow and spread. Radiation     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body     radiation therapy is a specialized radiation therapy that delivers a single, high dose of     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal     tissue. Giving atezolizumab together with stereotactic body radiation therapy may kill more     tumor cells and be a better treatment for non-small cell lung cancer that cannot be removed     by surgery.   "
52416|NCT02599441|"     To compare measures of ankle stability from an investigational cone beam computed tomography     scanner to gravity stress X-ray in patients who have unstable supination-external rotation     ankle fractures.   "
52417|NCT02599428|"     This project aims to investigate the physical, mental and cognitive recovery after admission     to the Intensive Care Unit (ICU).      This will be done by a three and 12 month follow up after discharge. The patients will be     scored with four validated methods for evaluating their health related quality of life,     anxiety and depression, cognitive function and physical impairments   "
52418|NCT02599415|"     This is a pilot study to investigate the effect of TL01 narrow band UVB therapy on the     resident dermal dendritic cells characterized by expression of CD1c and CD141. These cells     were reported to have a role in induction of tolerogenic regulatory T cells and production of     IL-10. The investigators proposed to investigate the effect of NB-UVB on these subsets of     cells after two weeks of treatment to provide better understanding of the mechanism of action     of light treatment.   "
52419|NCT02599402|"     The purpose of this study is to determine the effects of combination treatment of Nivolumab     with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated     advanced Melanoma.   "
52420|NCT02599389|"     The aim of this multicenter triple-arm randomized study is to compare two innovative     techniques with the gold standard currently used and providing unsatisfactory results for the     In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the     use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the     Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous     material to the standard angioplasty using plain balloons. INTACT study main objective is to     assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent     restenosis by comparing these two innovative strategies and the standard one in terms of cost     per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.   "
52433|NCT02599220|"     This study examines the clinical outcomes and healthcare costs associated with gram negative     bacteremia at Duke University Medical Center from 2002-2015.   "
52434|NCT02599207|"     This study is a single site, phase I, prospective study of the safety of intravenous sibling     cord blood infusion in 15 children ages 1-6 years with Cerebral Palsy (CP). All subjects will     be treated with sibling cord blood cells. The first six will receive cord blood cells from an     HLA-matched sibling. The following nine subjects will receive cord blood cells from an     HLA-mismatched (≥3/6 match) or matched sibling. The duration of study participation will be     six months from the time of the cord blood infusion.   "
52435|NCT02599194|"     The goal of this Phase II clinical trial is to further evaluate the ability of 18F-FSPG to     diagnose, prognosticate, and evaluate response to therapy in patients with a wide variety of     metastatic cancers.   "
97875|NCT02005068|"     This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint     infections.   "
52421|NCT02599376|"     Obesity has become one of the most common risk factors in obstetric practice with serious     anaesthetic implications. Obese pregnants have limited physiological reserves and     cardiovascular co- morbidities when compared to non-obese pregnant women. Spinal anaesthesia     is the anaesthetic technique of choice for caesarean section. The haemodynamic changes     associated with spinal anaesthesia pose the greatest hazard to the mother and the foetus and     are exaggerated in obese pregnant women. However differences in the changes in haemodynamic     variables such as cardiac output (CO), stroke volume (SV) and systemic vascular resistance     (SVR) between obese and non-obese pregnant women having caesarean section (CS) under spinal     anaesthesia have not been studied before. This study compares the haemodynamic changes after     spinal anaesthesia for CS in non-obese and obese parturients in a single centre, prospective     case control study, using LiDCOrapidV2. This LiDCOrapidV2 device is a noninvasive method of     measuring haemodynamic variables. It is a single centre, prospective, case control study. The     primary outcome compares the differences and variability in CO, SV and SVR between obese and     non-obese parturients. The secondary outcomes include comparison of the correlation between     changes in blood pressure (BP) and CO in each patient and the difference in BP between     conventional intermittent oscillometric device and continuous LiDCORapidV2in each patient     with a view to assess the need for measurement of cardiac output in obstetric anaesthesia   "
52422|NCT02599363|"     This is a Phase I study to assess the safety and MTD of paclitaxel + ribociclib (LEE011) in     patients with Rb+, advanced breast cancer. Dose escalation will be performed using standard 3     + 3 dosing strategy. The starting dose of ribociclib (LEE011) is 200 mg once daily; dose     escalation proceeds in 200 mg increments up to a maximum of 600 mg. Dose-limiting toxicities     (DLT) will be based upon first-cycle toxicity.   "
52423|NCT02599350|"     In an attempt to standardise the degree of impairment of gas exchange in the lungs of ICU     patients a number of indices of oxygen exchange have been developed. These include: the     arterial−alveolar oxygen tension ratio (a/APO2), the arterial oxygen tension−inspired oxygen     concentration ratio (PaO2/FIO2), the respiratory index (RI), [A−a)DO2/PaO2) and the     alveolar−arterial oxygen tension difference [A−a)DO2). These are used clinically despite the     fact that they do not accurately predict gas exchange particularly with changing the amount     of inspired oxygen or when there is mixing of oxygenated blood with unoxygenated blood in the     patient (called shunt). None of the indices reliably reflect the behaviour of the     physiological shunt. In a pilot study as inspired oxygen (FIO2) was increased incrementally     from 0.30 to 1.00, up to 55 per cent of the measured changes in these indices were opposite     in direction to the corresponding changes in the physiological shunt. The investigators have     developed a computer algorithm and a slide rule to try and improve on these clinical     measures. The investigators wish to test their slide rule on ventilated patients by altering     the inspired oxygen to see if it will predict what the actual change in oxygen will be.   "
52424|NCT02599337|"     Randomized, open-label, 3-way reference replicated crossover bioequivalence study of     sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects     under fasting conditions.   "
52425|NCT02599324|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of the     combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in     selected advanced gastrointestinal and genitourinary tumors.   "
52426|NCT02599311|"     One thousand patients with stage＞2 POP are recruited. The patients are all received     surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair     surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded.     Postoperatively, the investigators investigate the indications and clinical efficacy of     pelvic organ prolapse surgery.   "
52427|NCT02599298|"     The aim of this randomized, open-label clinical trial is to determine the impact of Sleep     Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and     behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute     coronary syndrome on cardiovascular outcomes. We hypothesize that SGMT will result in a lower     (1) plasma NT-pro BNP level, (2) 10-year risk of cardiovascular mortality based on the     European SCORE algorithm, and (3) cardiovascular event rate, when compared with Standard     Therapy.      OSA is an emerging cardiac risk factor and prognostic marker. We have reported that OSA is a     prevalent and independent predictor of adverse outcomes in patients with acute coronary     syndrome. In this clinical trial, a continuation of my research and publication trajectory,     180 patients presenting with acute coronary syndrome will be randomly assigned to SGMT (n=90)     or Standard Therapy (n=90) groups. Both groups will receive guideline-mandated treatment for     acute coronary syndrome. Those assigned to SGMT will undergo a sleep study. Those found to     have OSA will attend the SGMT clinic run by a multidisciplinary team. Advice on continuous     positive airway pressure and behavioral therapy (weight loss, exercise, positional therapy,     abstinence of alcohol and sleeping pills) will be given. The primary endpoint is plasma     NT-pro BNP concentration at 6-month follow-up. The secondary endpoint is 10-year risk of     cardiovascular mortality based on the European SCORE algorithm which includes age, sex,     smoking status, systolic blood pressure, and serum total cholesterol or total/HDL-cholesterol     ratio. Adverse cardiovascular events at 3-year follow-up will be determined.      In our aging population with an increasing prevalence of obesity, OSA will potentially become     an increasingly important contributor to cardiovascular disease. Leveraging the collective     expertise of a team of cardiologists and sleep physicians, our work will benefit society by     advancing our understanding of the cardiovascular benefits of screening for and treating OSA.   "
52428|NCT02599285|"     In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial     fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and     reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Widening     and chronical instability of the syndesmosis is related to worse functional outcome and     development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical and     clinical evidence that syndesmotic stability in AO Weber type C fractures with an additional     posterior malleolar fracture can also be reached by fixation of the posterior malleolar     fragment. Maybe, this is even superior to the usual treatment with syndesmotic positioning     screws. Some authors concluded that stability of the syndesmosis in these fractures can be     much more achieved by fixation of the posterior malleolar fragment than by placement of     syndesmotic positioning screws alone. Another additional benefit of open reduction and     fixation of the posterior malleolar fragment is that this will lead to an anatomical     reconstruction of the syndesmosis. Although there is no current evidence, it is likely that a     malreduction of the fibula in the tibial incisura will lead to a worse functional outcome on     the long-term. No clear consensus in the literature is found as to which fragment size of the     posterior malleolus should be internally fixed. The general opinion is that displaced     fragments that involve more than 25% of the distal articular tibia should be fixed.     Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous     screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve     an anatomical reduction, and that percutaneous fixation of smaller fragments is very     difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach     in prone position, followed by open reduction and fixation with screws in posterior-anterior     direction or antiglide plate is advocated by several authors. This approach allows perfect     visualization of the fracture, articular anatomical reduction, and strong fixation. Another     advantage is that even small posterior fragments can be addressed. Several case series are     published, which describe minimal major wound complications, good functional outcomes, and     minimal need for reoperation.   "
52429|NCT02599272|"     The study will investigate whether having mixed spices rich in polyphenols can improve     postprandial cardiometabolic response in healthy Chinese men.   "
54878|NCT02567318|"     The purpose of this prospective study is to investigate the degree of association between the     volume of important pain-relevant structures in the brain and the size of the areas of     secondary hyperalgesia.   "
52437|NCT02599168|"     Dexmedetomidine, a selective alpha-2 agonist agent used for maintaining sedation in intensive     care patients in receipt of mechanical ventilation, is being increasingly utilized in     anaesthesia practice for facilitating anaesthesia depth as an adjunct to base anaesthetics     (intravenous; propofol: inhalational; sevoflurane, desflurane). The investigators intend to     assess the anaesthetic potential of dexmedetomidine in controlled anaesthesia settings     empowered by the use of an objective, patient response based, safe, efficient, and patented     closed loop anaesthesia delivery system (CLADS). CLADS functions on control of processed EEG     response parameter captured from anaesthetized patients with the help of a BIS- monitor,     which is continuously fed into a automated drug infusion pump. The infusion pump then     accordingly delivers the anaesthetic drug to the patients based on pharmacodynamic     requirements. If dexmedetomidine has anaesthesia potential then it is likely that propofol     use delivered by CLADS can be reduced further. In addition the effect of two drugs (viz, base     agent-propofol plus adjunct agent-dexmedetomidine) on different receptor site within the     brain would help gain greater anaesthetic depth consistency as well as a lower incidence of     intraoperative patient awareness. This prospective randomized two-arm study aims to assess     effect of the use of dexmedetomidine on propofol requirements (primary objective),     anaesthesia depth consistency, and intraoperative patient awareness (secondary objectives).   "
52438|NCT02599155|"     The investigator will evaluate the influence of colloid administration on postoperative acute     kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.   "
52439|NCT02599142|"     Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent     patient movement and improve treatment accuracy. These shells tend to cover the face and have     the potential to cause anxiety and distress in patients, particularly if they suffer with     claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover     the face and compare this with the investigators' current 'closed-face' shell. The     investigators will obtain treatment verification x-ray images to assess the daily set-up     errors and compare these between the two shell type, and ask both patients and radiographers     of their experiences from using the shells.      Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of     radiotherapy delivery and are better accepted by patients and radiographers as compared to     closed-face immobilisation shells for cranial radiotherapy.   "
52440|NCT02599129|"     Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can     fall out on the scalp or elsewhere on the face and body.      Alopecia areata is an autoimmune skin disease, which means that the immune system is     recognizing the hair follicles as foreign and attacking them, causing round patches of hair     loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss     (alopecia universalis). The scalp is the most commonly affected area, but the beard or any     hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in     males and females of all ages, and is a highly unpredictable condition that tends to recur.     Alopecia areata can cause significant distress to both patients and their families.      Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia     areata. A total of 30 patients will be included in the study, which will run for a total of     28 weeks.   "
52441|NCT02599116|"     This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with     peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic     intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and     post-operatively.   "
52442|NCT02599103|"     Fats and oils play important roles in maintaining human nutrition and health through     providing energy, essential fatty acids, and acting as modulators of many biological     processes (signal transduction, immunity and inflammation). Due to differences in the fatty     acid composition and content of antioxidants of individual cooking oils, the degree of     oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study to     investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse     effects. The investigators are also lack of biomarkers for monitoring deep-fried oil     exposure. Therefore, the purpose of this study is to compare how human body responds     differently to several popular uncooked and deep-fried oils with varied fatty acid     compositions with respect of oxylipin profile, inflammatory markers, non-targeted     metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided     them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil,     camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison     with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time; serum,     plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4     hours. The investigators anticipate to find biomarker(s) for deep-frying, and contribute to     the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward     health through integrative omics or so-called system biology approaches.   "
52443|NCT02599090|"     The goal of this clinical research study is to find the highest tolerable dose of sorafenib     that can be given in combination with temozolomide. The safety of this combination will also     be studied.   "
52463|NCT02598830|"     This study evaluates the effect of vitamin D supplementation on outcomes of 12 weeks     progressive strength training in 130 ageing subjects (>45 years of age). Participants will be     recruited into two similarly sized strata; one containing COPD patients and one containing     healthy subjects. In each stratum, half the participants will receive vitamin D     supplementation and half the subjects will receive placebo   "
52464|NCT02598817|"     The purpose of this study is to evaluate the effects of term infant formula containing high     2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal     (GI) Tolerance.   "
52465|NCT02598804|"     The primary purpose is to evaluate the benefit of an education action of exercise on the     level of physical activity in patients with knee osteoarthritis with the waning of a spa     treatment for three weeks, three months after the start of the cure.   "
52466|NCT02598791|"     With the present study, the investigators aim to delineate the effects of GIP/GLP-1 receptor     co-activity on food intake, appetite, bone health and fat metabolism in overweight/obese     subjects.   "
52467|NCT02598778|"     This study compares four mouth rinses in their regard to reducing Streptococcus Mutans after     use. The four mouth that will be compared are chlorhexidine gluconate (.12%), sodium fluoride     (.05%), coconut oil, and deionized water.   "
52444|NCT02599077|"     Project Summary Endometriosis is a disease with a high prevalence that primarily affects     women of childbearing age. This condition brings an important physical and emotional burden     on sufferers and this is why it requires proper and timely medical management. At present     there are several first-line drugs available for the management of symptoms and disease     control. In the world literature we have reported several studies that demonstrate the     effectiveness of different groups of drugs such as oral contraceptives, progestins, GnRH     analogues and danazol. Within the available scientific evidence it has been extensively     described the benefits of the new progestins Dienogest, demonstrating a favorable safety     profile and efficacy along with a significant reduction of the symptoms of the disease by its     anti-inflammatory, and antiproliferative antiagiogénicas in the endometrial tissue . However,     although the therapeutic properties of this drug are known, studies are needed to compare its     effectiveness with the effectiveness of other therapeutic agents as oral contraceptives. That     is why the main objective of this study is to evaluate the impact of Dienogest to 2 mg / day     compared with a combined oral contraceptive (levonorgestrel + ethinyl estradiol) in the size     of the endometriomas diagnosed by transvaginal ultrasonography in 50 women having diameters     less than 4 centimeters of the same, which medical management will be given for one year at     the University Hospital Fundación Santa Fe de Bogota. The study was conducted by a clinical     trial, randomized, single-blind by the observer. The results will be analyzed and the     findings in the study will serve as a tool to define new therapeutic conduct in the     management of endometriosis.   "
52445|NCT02599064|"     This study is designed to evaluate the safety, tolerability and clinical activity of RXI-109     administered by intravitreal injection to reduce the progression of subretinal fibrosis in     subjects with advanced neovascular age-related macular degeneration (NVAMD).   "
52446|NCT02599051|"     A randomized control trial to compare the efficacy of the single incision mini-sling to the     transobturator sling   "
52447|NCT02599038|"     In this study, the investigators aim to increase the liver tissue level of GSH in NAFLD     patients by short-term dietary serine supplementation and improve their liver function by     lowering the oxidative stress resulting from hepatic steatosis.   "
52448|NCT02599025|"     The investigators will examine the immediate contribution of position and movement on the     functioning of the autonomic cardiac control system.   "
52449|NCT02599012|"     -  Multifactorial pathogenesis is involved in anemia of cancer patients and defining the          causes of anemia is not always simple.        -  Currently, treatment options available for anemia in cancer patients include red blood          cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron          supplementation, accompanying considerable pros and cons for each treatment.        -  Previous studies have demonstrated benefit when treating with IV iron in combination          with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.        -  In this study, investigator will assess the efficacy of intravenous iron for the          treatment of anemia in cancer patients.   "
52450|NCT02598999|"     This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety,     tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending     doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination     (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis.   "
52451|NCT02598986|"     Glycemic index (GI) of food is known to be positively associated with the development of     several diseases including type 2 diabetes, cardiovascular disease and age-related macular     degeneration. Modest dietary changes from high-GI foods to low-GI foods have shown beneficial     effects. These findings have been translated to recommendations for increased dietary intake     of whole grains. However, the inverse relationship between whole grain consumption and risk     of the different components of metabolic syndrome has not been explained by their fiber     content. Trials of added cereal fiber have failed to induce a protective effect and fiber has     thus been proposed to be a marker of other components of whole grains that impart health     advantages. Whole wheat grains are known to be a rich source of several minerals (phosphorus,     potassium and magnesium) that play a role in glucose metabolism, and are depleted during the     process of refinement. Thus, it is plausible to hypothesize that the benefits of whole grains     previously ascribed to their fiber content are in fact due to these minerals. The proposed     research aims to restore or fortify white bread with these minerals and determine the     resulting glycemic index of mineral-fortified bread. With much evidence that most people     prefer the taste and color of white bread, a low GI, mineral fortified white bread has the     potential to reduce the risk of Metabolic Syndrome in those who consume it.   "
52452|NCT02598973|"     Parkinson's disease (PD) is a common neurodegenerative disorder affecting approximately     80,000 Veterans, representing a priority area for VA research. Current medicines for PD only     improve symptoms, treatments that slow disease progression are needed, and earlier diagnosis     of PD may be the key to their development. PD symptoms can be mimicked by medicines (most     commonly antipsychotic drugs that block dopamine), and some of these patients actually have     underlying prodromal PD that was unmasked years before it would have caused symptoms.     This problem is increasing as these medicines are now used for common conditions including     post-traumatic stress disorder and depression. The investigators will identify prodromal PD     in patients with drug-induced symptoms using brain scans. These patients will be enrolled in     a randomized clinical trial of aerobic exercise which slows progression in animal models of     PD and has other health benefits. The investigators will measure the effect of exercise on     symptoms, disease progression (using brain scans) and markers of PD risk (using blood tests).     These studies will improve early PD diagnosis and potentially identify a way to slow     progression of PD.   "
52453|NCT02598960|"     The purpose of this study is to evaluate the safety and tumor-shrinking ability of     experimental medication BMS-986156, when given by itself or in combination with nivolumab in     patients with solid cancers that are advanced or cancers that have spread.   "
52468|NCT02598765|"     The purpose of this study is to determine the reduction in intraocular pressure and     cumulative incidence of complications between the standard and micro trabeculectomy surgeries     3 months after surgery.   "
52515|NCT02598154|"     The main objective of this study is to evaluate the metrological characteristics of the data     processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement     relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of     a step and in the middle of the oscillating phase.   "
52454|NCT02598947|"     Shoulder impingement syndrome is a very common cause of shoulder pain and normally treated     with physiotherapy or surgery. Research has shown that physiotherapy is as effective as     surgery, however, the incidence of surgery for this condition is on the rise internationally,     nationally and locally. The most effective form of physiotherapy, however, is not known.     Laboratory studies have suggested that posterior shoulder tightness may contribute to     irritation of the soft tissue around the shoulder joint and perpetuate pain from shoulder     impingement syndrome. There is a lack of good quality evidence to support this perspective.     The aim of this study is to assess the feasibility of conducting a randomized controlled     trial to evaluate the effectiveness of treatment for posterior shoulder tightness in     combination with 'best care' compared with 'best care' alone in individuals with shoulder     impingement syndrome.      The study will be a randomised, controlled, double blind (patient and assessor), parallel     group, feasibility study with 1:1 allocation ratio. Patients awaiting surgery will be     assessed for inclusion/exclusion criteria and then randomly allocated into one of two groups.     60 patients will be assigned to receive 'best care' physiotherapy, with or without treatment     for posterior shoulder tightness.      Physiotherapy treatment will be delivered over 13-15 weeks and outcomes will be assessed at     0, 6-8, 13-15, 26 and 52 weeks. The results will help us to understand if this is an     important part of physiotherapy treatment, which might help reduce patient's pain and     disability as well as reduce the cost of treatment for the National Health Service.   "
52455|NCT02598934|"     This study will evaluate whether an early positive response to once-monthly oral ibandronate     in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy     later in treatment. The anticipated time on study treatment is 6 months, and the target     sample size is 360 individuals.   "
52456|NCT02598921|"     Evaluation of the endometrial cavity is an important step in the infertility work-up,     particularly if assisted reproductive therapy is planned. The aim is to identify possible     endometrial abnormalities that may impair implantation.Undiagnosed endometrial abnormalities     are present in 11 to 45% of women scheduled for in vitro fertilization (IVF).Traditionally,     two dimensional transvaginal ultrasound (2D TVUS) and hysterosalpingography (HSG) are the     basic methods for assessment of the endometrial cavity. However, these imaging modalities     have shown high false negative rates among infertile women, a finding that could confine     their rule to initial screening rather than definite diagnosis.      Office hysteroscopy (OH) is the gold standard for evaluation of the endometrial cavity.     Although the endoscopic approach has been proven to increase pregnancy rate in women who     experienced prior implantation failure, evidence on treatment of unsuspected     hysteroscopically-diagnosed endometrial lesions, to improve IVF outcome, is still lacking.     Nevertheless,clinicians tend to use OH routinely prior to IVF because the psychological and     financial burden that infertile couples may experience as a consequence of failed IVF cycle     is unjustifiable.Yet, costs and invasiveness of OH counteract its global implementation to     all women prior to IVF.   "
52457|NCT02598908|"     Participation in EQA schemes, where available, is mandatory for the United Kingdom     Accreditation Service (UKAS). No EQA scheme currently exists for TPMT and thiopurine     metabolites, which is a potential shortcoming of these tests. A pilot of this project has     been awarded funding by Clinical Pathology Accreditation (CPA).      The purpose of this work is to collect samples for an EQA scheme for whole blood TPMT     (activity and genotype) and thiopurine metabolites, which will be run in collaboration with     UK NEQAS (United Kingdom National External Quality Assessment Service), and facilitate a     comprehensive world-wide service that enables laboratories providing these tests to fulfil     quality goals and ultimately provide optimal patient care.   "
52458|NCT02598895|"     This pilot clinical trial studies docetaxel and carboplatin in treating patients with     prostate cancer that does not respond to treatment with hormones (hormone resistant) and that     has spread from the primary site (place where it started) to other places in the body     (metastatic). Drugs used in chemotherapy, such as docetaxel and carboplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading.   "
52459|NCT02598882|"     Assessment of energy expenditure and the quadriceps muscle fatigue of healthy seniors, after     two physical activities, being one of an activity guided by interactive video game (Xbox) and     another on the treadmill. The participants will perform the activities in two different days,     the order will be obtained by randomization.   "
52460|NCT02598869|"     Macular edema is the most common sight threatening complication of uveitis which can lead to     permanent loss of central vision. Triamcinolone acetonide ( the study drug)injection for     treatment of cystoid macular edema(CME) is well established. The purpose of this study is to     compare the safety and efficacy of injecting the study drug inside the eye(intravitreal     injection) and behind the eye(subtenon injection)   "
52461|NCT02598856|"     Opioid overdoses have in the last decade counted for about 230 untimely deaths annually in     Norway. The government is currently implementing a strategy for combating this epidemic.     Among the actions promoted in this strategy is the distribution of naloxone for intranasal     administration. Such administration of naloxone is currently being implemented and tried out     around the world, but very little has been done to pharmacologically study this new route of     administration of this well known drug, and only 3 open label randomized controlled trials     (RCTs) have been conducted. A recent guideline from the WHO on community management of opioid     overdoses is a comprehensive review of many of the aspects the investigators cover in our     research.      Regarding both dosage, routes of administration of naloxone and care of these patients in the     pre hospital setting. The WHO calls for nasal formulations with a higher concentration, as     well as focuses on the current wide spread off label use of nasal naloxone as a problem and     identifies several research questions of critical importance and very low evidence.The     current study, together with our research group's previous and future studies, aims to     provide data for the development of a medicinal product with marketing authorisation for use     in pre-hospital overdoses. This to contribute to public health measures for opioid users and     those around them.   "
52462|NCT02598843|"     The purpose of this study is to directly compare traditional plaster treatment with early     weightbearing in a walking boot for the non operative treatment of acute achilles tendon     rupture.   "
52531|NCT02597946|"     to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2     mutations, previously treated with 1 or 2 chemotherapy regimens   "
52471|NCT02598726|"     This pilot phase I trial studies the side effects and best dose of curcumin when given     together with piperine (piperine extract [standardized]) in reducing inflammation for     ureteral stent-induced symptoms in patients with cancer. Curcumin is a spice similar to     turmeric and works by decreasing the chemical moderators that produce inflammation in the     body. Piperine is pepper and works by increasing the amount of curcumin available in the body     when taken with curcumin. Giving curcumin together with piperine may reduce inflammation and     discomfort from a ureteric stent in older patients with cancer.   "
52472|NCT02598713|"     The goal of this interventional study is to test Quinine, Red and Blue food dye as markers of     aspiration (endotracheal tube [ETT] cuff leakage) in mechanically ventilated, critically ill     patients.   "
52473|NCT02598700|"     In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's     safe zone and functional anteversion are often used to assess appropriate orientation.     However, these approaches do not consider the effect of the spinopelvic chain and lumbar     mobility when in the seated position. This study will measure functional anteversion when     standing and sitting with patient-specific computer models and define a quantitative     relationship between the change in functional anteversion and spinopelvic parameters. This     will challenge the historical paradigm of the safe zone and provide a tool to define     anteversion based on a patient's mechanics and reduce risk of dislocation.   "
52474|NCT02598687|"     Open-label, single-center phase 1 study of an investigational agent TH-302 and standard     chemoradiotherapy with a 3+3 dose escalation design through 3 dose levels.   "
52475|NCT02598674|"     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly     recognized as a significant factor associated with long-term mortality among different     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in     the development of hypertension and cardiovascular disease. The investigators overall     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,     long-term consequences with regard to kidney function, endothelial function, blood pressure     control, and overall health.   "
52476|NCT02598661|"     The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion     dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is     relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.   "
52477|NCT02598648|"     In the clinical data, the changes of RIPK3 and FXR were monitored in the lung lavage fluid     and blood from the patients.      In vivo experiments to find high risk factors to induce AEC necrosis and further lead to ARDS     evidence, can provide a more direct theoretical research foundation for the pathogenesis of     ARDS.   "
52478|NCT02598635|"     Aim: To investigate whether cholecalciferol (4800 U/daily) or placebo for 16 weeks reduces     proteins levels associated with vascular calcification (osteoprotegerin, osteopontin,     osteocalcin) in patients treated with peritoneal dialysis and 25(OH) vitamin D deficiency.   "
52479|NCT02598622|"     The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent     painful nerve damage and nerve pain which is caused by vincristine, a drug used in     chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug     available for purchase as a nutritional supplement but for the purpose of this study is     experimental.   "
52480|NCT02598609|"     Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for     a high morbidity and mortality. Possible severe adverse events are central line associated     bloodstream infections (CLABSI), ventilator and catheter associated adverse events and     medication errors. Severity of the patient's outcome after an adverse event can be classified     using the National Coordinating Council for Medication Error Reporting and Preventing (NCC     MERP) Index for categorizing medication errors.      The study will test the hypothesis that rates of adverse events in NICU patients will be     reduced by the implementation of an educational program for the NICU caregivers (nurses and     physicians), consisting of strategies for recognizing and preventing adverse events in their     unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal     complications and ventilator and catheter-associated adverse events.      This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France     will be randomized to the timing of implementation of the educational program.      In order to describe the adverse events occurring during the study period, an anonymous     voluntary adverse event reporting system will be provided to the caregivers of the     participating units. A nested study will examine how caregivers communicate with the     patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).      The rates of adverse events will be measured retrospectively using a neonatal NICU trigger     tool.   "
52481|NCT02598596|"     The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of     pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients     with chronic, refractory gout.   "
52482|NCT02598583|"     The primary purpose of this study is to evaluate the safety, tolerability and efficacy of     multiple IV doses of ALXN1210 administered to patients with PNH   "
52483|NCT02598570|"     This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese     participants with relapsed or refractory lymphoma.   "
52509|NCT02598232|"     This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system     (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to     alleviate back pain in a lumbar herniated intervertebral disc patient.   "
62117|NCT02472522|"     Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus     abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean     Section.   "
52484|NCT02598557|"     This randomized phase IIb trial studies how well alternative dosing of exemestane before     surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast     cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming     back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the     exemestane standard dose regimen versus two alternative, less frequent dose regimens may     decrease undesirable symptoms and be more effective in treating breast cancer.   "
99562|NCT01983111|"     The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal     system to tramadol/acetaminophen.   "
52485|NCT02598544|"     Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in     obesity and diabetes. An important characteristic when examining AT function is the capacity     to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the     aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in     different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects     with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge     gained from this research will contribute to a better understanding of the present adipose     tissue dysfunction and to the optimization of exercise programs for people with obesity and     diabetes.   "
52486|NCT02598531|"     The purpose of the SWIFT Trial is to answer two research questions.        1. Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative          and long-term outcomes of TKA in extreme obesity?        2. Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?   "
52487|NCT02598518|"     The purpose of this study is to assess the effectiveness and implementability of ICT for     co-occurring alcohol use and mental health disorders within community addiction treatment, as     delivered by routine community addiction clinicians.   "
52488|NCT02598505|"     The purposes of this study are:        1. To confirm safety of Indacaterol in stable Heart Failure.        2. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to          ameliorate lung diffusion in heart Failure patients treated with beta blockers.        3. To compare the effects of Indacaterol in patients treated with a non-selective beta          blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).   "
52489|NCT02598492|"     The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among     mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to     impute the PF ratios in assessing the respiratory parameter of the SOFA score.   "
52490|NCT02598479|"     The IPTLD QoL Broad Study.   "
52491|NCT02598466|"     Research question: what are the patterns of patient-reported changes in physical function     among adult patients using SC abatacept with moderate to severe RA since commencement of the     compassionate use program (CUP).   "
52492|NCT02598453|"     The purpose of this study is to evaluate treatment adherence to different regimens of     ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to     daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects.     The anticipated time on study treatment is 12 months, and the target sample size is 517     individuals.   "
52493|NCT02598440|"     This study will evaluate participant-reported preference for either ibandronate or a     comparator drug in women with postmenopausal osteoporosis. The anticipated time of study     treatment is 6 months, and the target sample size is 338 individuals.   "
52494|NCT02598427|"     The purpose of this research study is to determine how well pertuzumab and trastuzumab works     in treating breast cancer that has spread to the brain. Pertuzumab and trastuzumab are     treatments that stop breast cancer cells from growing abnormally by inhibiting (or blocking)     members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).      Pertuzumab and trastuzumab have been found to be very effective for HER2-positive breast     cancer and are FDA approved for treatment of metastatic breast cancer outside of the brain     when given through the vein. This suggests that pertuzumab and trastuzumab may help shrink or     stabilize HER2-positive breast cancer that has spread to the brain in this research study.      In this research study, the investigators are looking to see whether pertuzumab and     trastuzumab will work to decrease the size of or stabilize breast cancer that has spread to     the brain.   "
52495|NCT02598414|"     In colorectal surgery, anastomotic leak and its septic consequences still remain as the most     concerning complications resulting in substantial morbidity and mortality. A common     determining factor for assessing the viability of a bowel anastomosis is adequate arterial     perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared     fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which     allows the surgeon to choose the point of transection at an optimally perfused area before     creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the     robotic systems and this helps identify intravascular NIF signals in real time.      Although reports from several case series and retrospective cohorts have described the     feasibility and safety of this imaging system during robotic colorectal surgery, to date, no     studies have addressed more systematically the outcomes of this technique in robotic surgery.     Considering the limitations of these reports, investigators aim to conduct a prospective     randomized trial to compare robotic procedures with or without INIF imaging in patients     undergoing colorectal surgery.   "
52497|NCT02598388|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of     different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly     (IM) as heterologous prime-boost regimens in healthy and in HIV-infected adults.   "
52510|NCT02598219|"     The aim of this study is to evaluate the sentinel node policy in early stage endometrial     carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy     to current French initial staging protocols).   "
52511|NCT02598206|"     The purpose of this study is to evaluate the effect of food intake on PF-04136309     pharmacokinetics (PK) following a single dose at 1000 mg.   "
62801|NCT02463630|"     Posterior compression - distraction reduction technique （CDR） in the treatment of Basilar     invagination associated with atlantoaxial dislocation   "
52517|NCT02598128|"     Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that     anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.     Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding     in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.   "
52518|NCT02598115|"     The primary objective of this study is to evaluate the impact of the implementation of     collaborative pharmaceutical care on drug support at admission for patients 65 years of age     and older.      This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to     participating centers. A randomly selected center is crossed-over into the intervention every     fifteen days after the start of inclusions.   "
61389|NCT02482038|"     This study is designed to look at the effect of the geko device on the circulation in lower     limbs of participants with venous leg ulcers.   "
52498|NCT02598375|"     Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill     children in the PICU (ERTEN in PICU).      In critically ill children, there is no data on the factors influenced the enteral nutrition     and feeding intolerance.The investigators aim to reach these goals in our study        -  To initiate the enteral feeding in pediatric intensive care units or not        -  To demonstrate the reasons whether early enteral feeding is initiated or not        -  To determine the incidence of feeding intolerance        -  To identify the situations such as analgesia ,sedation, catecholamines or individual          preferences of the medical staff which lead to delay or interruption in enteral feeding          in pediatric intensive care units        -  To investigate the relation between the successful enteral feeding and mortality ,          morbidity du to the sepsis , septic shock and multiorgan failure      Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU     (IFABP in PICU)      Critically ill children are at increased risk for intestinal injury, gastrointestinal     dysfunction and feeding intolerance, which are associated with delayed recovery and increased     morbidity and mortality during their course in the pediatric intensive care unit. In     critically ill children, there is little data on the factors influenced the enteral     nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early     intestinal damage due to these medications.      Aim There is no information which shows that the role of the intestinal microcirculation     problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim     to reach these goals in our study        -  To show the value of IFABP regarding the identifying feeding intolerance and early          detection of enteral feeding intolerance        -  To show the relation between the IFABP concentration and enteral feeding intolerance        -  To show the relation between the mechanical ventilation settings , sedation , inotropic          medications doses and IFABP concentration and feeding intolerance        -  To show the relation between IFABP concentrations and mortality and morbidity due to the          sepsis , septic shock and multi system organ failure      Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be     delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients     within 48 h after PICU admission. Patients with Early Initiation of Feeding were     statistically significant more likely to have ERTEN. ERTEN was independent significant     prognostic factors for survival (p<0.001), with reached target enteral caloric intake on day     2 indicating improved survival.   "
52499|NCT02598362|"     Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in     children aged 3 months - 17 years who are treated for urinary tract infections.   "
52500|NCT02598349|"     The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical     candidates is poor. Patients characterized as having borderline resectable disease treated     with preoperative chemo-radiotherapy fair somewhat better - although many of these patients     are not converted to resectability. It may be argued that intensification of local and     regional therapy might 1.) Increase the share of patients able to undergo curative surgery     and 2.) Improve the local disease control interval and extend survival for patients who     remain unresectable. Therefore, the purpose of this research study is to determine if an     increase in the number of surgical resection pancreatic adenocarcinoma is higher than     historical data by using a combined treatment of proton radiation with capecitabine (oral     chemotherapy).   "
52501|NCT02598336|"     Measurements of Structured Light Plethysmography (SLP) using a chest wall movement based     method will be compared to those obtained by spirometry using a flow based pneumotachograph     method. This study will enable validation of SLP in children and adults by allowing direct     comparison of simultaneous measurements of breathing sequences using the two measurement     techniques.      The investigators will also examine, in a group of normal adults, repeatability of the     agreement between the two devices, and whether the agreement is affected by a change in tidal     breathing parameters.   "
52502|NCT02598323|"     State of the question and research objective: International trials have shown that ultrasound     measurement of the cervix identifies a population at high risk of preterm delivery. In case     of short neck several types of treatments can be recommended: progesterone, the establishment     of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There     is no French study.      The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by     introducing a routine ultrasound screening strategy asymptomatic short necks.      Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA     are eligible to ultrasound of the cervix.        -  Primary endpoint: delivery rate before 37 weeks.        -  Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality          morbidity.      Expected result: a prematurity of 50%   "
52503|NCT02598310|"     The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab     for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.   "
52504|NCT02598297|"     Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive     disease with increased risk of leukemic transformation and reduced overall survival. As there     are no therapies currently established in the subset of high molecular risk patients with     early myelofibrosis, the study aims to evaluate ruxolitinib in this patient population.   "
52505|NCT02598284|"     This study evaluates the ability of small primary care practices to 1) implement     point-of-care and population management quality improvement strategies to improve     cardiovascular quality of care (e.g., clinical decision support, patient education and     counseling, or referral to smoking quit lines), and 2) implement the PopHealth performance     measurement software to evaluate performance on the ABCS (aspirin when appropriate, blood     pressure control, cholesterol management, and when applicable, smoking cessation) and allow     regional benchmarking. This minimal risk study is a practice-randomized trial to determine a)     whether point of care strategies improve ABCS performance measures compared to baseline, and     b) whether adding locally tailored population management strategies to POC strategies     improves performance on the ABCS measures more than POC strategies alone.   "
52506|NCT02598271|"     Acute kidney injury (AKI) is an infrequent but major and well - recognized complication of     cardiac surgery. Recent studies demonstrated that even minimal increases in serum creatinine     are associated with a rising risk of mortality, hospital length of stay, and cost.     Furthermore a cut-off for baseline serum creatinine and its influence on mortality after     cardiac surgery has been shown.      In this study the investigators want to test if increased bSCr is influenced by body     composition. Further the investigators want to determine if the incidence of AKI is different     in patients below or above the estimated cut-off. Therefore the investigators want to perform     a prospective cohort analysis and will take several other body composition and nutrition     parameters to test their influence on the predictive power of bSCr. Furthermore the     investigators want to evaluate several novel biomarkers for AKI on their predictive effect in     cardiac surgical patients.   "
52507|NCT02598258|"     The purpose of this study is to determine the safety on sauna followed by cold water bath, a     common practice in many countries, 30 healthy subjects aged 40 years and older will be at the     Montreal Heart Institute Prevention and Cardiac Rehabilitation centre.   "
52508|NCT02598245|"     Transobturator tapes (TOT) are placed according to the surgical technique described by     Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy     (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator     sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator     sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After     suturing the vaginal skin the Hegar sounds are removed.   "
52519|NCT02598102|"     Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are     usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of     pain during this procedure and also continue to have discomfort during voiding for few days.     The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac     suppository during flexible cystoscopy has been proven to be effective. This study was done     to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent     removal by rigid cystoscopy when compared to placebo and to assess its safety in these     patients   "
52520|NCT02598089|"     This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of     subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1;     A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and     female adults 18 through 45 years of age will be randomized to receive vaccine (30) or     placebo (30).   "
52521|NCT02598076|"     All subjects will attend an initial clinic visit with the neuropsychiatrist and     epileptologist. At the end of this visit, those subjects randomized to motivational     interviewing will be questioned using standardized motivational interviewing techniques by     the study author who is a board certified neurologist and who will have formal training and     certification in motivational interviewing.      Those subjects randomized to the control group will also undergo an initial clinic visit with     a neuropsychiatrist and neurologists. However they will not undergo any subsequent     motivational interview. Following the initial clinic visit, all subjects with ongoing     seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham     and Women's Hospital or referred to a local psychotherapist according to their preference.      All subjects will be contacted by phone at 3 month follow-up. If necessary they will be     called 5 times at various times during the day and early evening. If they are not reached,     they will receive a letter requesting them to contact the study staff to complete the study.     Subjects will be questioned about their adherence to treatment. The primary outcome will be     the number of psychotherapy sessions for the treatment of PNES in which they have     participated over the past three months. They will also be assessed for secondary outcomes     including dichotomous adherence (either seizure freedom or active participation in     psychotherapy for the treatment of PNES, with more than 5 sessions over the past 3 months),     seizure frequency over the past month, number of hospitalizations and emergency department     visits over the past 3 months, and quality of life as measured by the brief QOLIE-10     instrument. For those patients who give permission, their psychotherapists will be contacted     by study staff to confirm the exact number of psychotherapy sessions over the past 3 months.     A standard Partners clinical records release form with the patient's signature will be sent     to the therapist's office.   "
52522|NCT02598063|"     This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in     participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will     be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral     lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine     for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target     sample size is 255 individuals.   "
52523|NCT02598050|"     The purpose of this work is to determine whether preoperative cognitive screening of patients     over the age of 65 can be used as predictor of postoperative outcomes in patients undergoing     lower extremity surgical procedures. This work is important as it may aid patients, families     and physicians about the appropriateness of the surgical procedure and in providing resources     to patients who are at the highest risk of adverse outcomes.   "
52524|NCT02598037|"     Obesity is considered one of the most troubling chronic diseases for public health because of     its rapid growth in the population. Many are the causal factors of this epidemic, and in     recent years studies suggest the involvement of genetic factors in the etiology of obesity as     a risk factor for its development. Polymorphism of the FTO gene is being studied in the past     eight years and has been indicated as a predictor of obesity in the population, as well as     associations in food intake, raising the possibility of influence in the regulation of hunger     and satiety. Accordingly, researchers observed changes in levels of postprandial leptin and     ghrelin, which can promote appetite and change the quantity and quality of food intake in     subjects with the polymorphism FTO.   "
52525|NCT02598024|"     The purpose of this study is to determine whether two types of short-term trauma-focused     therapies (individual Narrative Exposure Therapy and group-based Control-Focused Behavioural     Treatment) are effective in the treatment of chronic PTSD in earthquake survivors of Nepal.   "
52526|NCT02598011|"     This is a multi-center, open label trial of combination therapy with Toca 511 and ascending     doses of Toca FC added to the SOC for newly diagnosed HGG.   "
52527|NCT02597998|"     The aim of this study is to assess the mass balance recovery from excreta of carbon 14     labelled BI409306 ([14C] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide     plasma, urine and faecal samples for metabolite profiling and structural identification.   "
52528|NCT02597985|"     Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk     elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients     undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown     whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes     after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to     improve physical performance before TAVR improves outcomes after TAVR.   "
52529|NCT02597972|"     Will patients who suffer complex humerus fractures have better functional outcomes and less     implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA)     compared to shoulder repair (open reduction and internal fixation, ORIF)?   "
52530|NCT02597959|"     1. What are the risk factors that contribute to musculoskeletal injuries and fatigue on          allied health professionals in surgical care (e.g. scrub nurses, surgical assistants,          and circulating nurses)?        2. Can the investigators design wearable devices that the investigators can later evaluate?   "
52532|NCT02597933|"     Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from     multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the     main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc     and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in     idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung     fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of     nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial     will be conducted as a double blind, randomised, placebo-controlled trial with primary     efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to     a maximum of 100 weeks). Respiratory function is globally accepted for assessment of     treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity     (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with     SSc-ILD.   "
61819|NCT02476435|"     The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic     stimulation in patients with depersonalization disorder.   "
52533|NCT02597920|"     The aim of this non-interventional study is to describe patient's perception of anticoagulant     treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from     atrial fibrillation (according to its approved indication in the approved dosages of 110 mg     or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).   "
52534|NCT02597907|"     The purpose of this study was to compare the antiemetic efficacy of aprepitant plus     palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic     cholecystectomy.   "
52535|NCT02597894|"     This pilot clinical trial studies targeted biopsies in determining response in patients with     prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which     radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or     near a tumor). Studying tumor tissue obtained before and after treatment may help doctors     understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired     after it is damaged and to see if there are differences in the prostate tissue prior to and     after starting androgen deprivation therapy.   "
52536|NCT02597881|"     The purpose of this study is to create an electronic registry to house phenotypic information     from patients with achondroplasia. The initial focus of this registry will be to include U.S.     patients with achondroplasia. Once populated, the collective data can be queried to pursue     clinical research questions pertaining to health outcomes and treatment options for patients     with this conditions. The registry is longitudinal in nature with the functionality to     retrospectively enter patients' clinical data from the prenatal period up through the most     recent encounter, with all intervening data entered in a chronologic fashion.   "
52537|NCT02597868|"     A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine     therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after     capecitabine-base chemotherapy.   "
52538|NCT02597855|"     To compare the short-term effect of intravitreal aflibercept injection between two subtypes     of polypoidal choroidal vasculopathy   "
52539|NCT02597842|"     This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of     this study is to compare the effect of TEAS pretreatment with single acupoint or two     acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic     operation.   "
52540|NCT02597829|"     A prospective open label trial of adult patients with active Crohn's disease to determine if     plasma concentrations of certolizumab pegol correlate to mucosal healing.   "
52541|NCT02597816|"     Congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women     with a history of recurrent miscarriage, with septate and sub-septate uterus being the most     common anomalies in these women, Also, septate uterus is the commonest anomaly found in     infertile women requiring assisted reproductive technology.      Published data showed improved Cumulative pregnancy rate and live birth rate, and a     significant reduction in Miscarriage rate in In Vitro Fertilization women after hysteroscopic     metroplasty of both small and large septate compared to non-operated women.      Investigators hypothesized that trans-vaginal three Dimensional Ultrasound will be superior     to Hystro-salpingography for the differentiation between arcuate and septate uterus in     infertile women scheduled for In Vitro Fertilization.   "
52542|NCT02597803|"     The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic     Solutions to placebo for the treatment of the signs and symptoms of dry eye.   "
52543|NCT02597790|"     The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV     only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk     for cardiovascular disease. Participants will undergo non-invasive assessment of     cardiovascular disease risk through measurements of endothelial function and blood biomarkers     at baseline and 1 year (or 4 weeks after end of HCV treatment for those that undergo HCV     treatment during study follow-up).   "
52544|NCT02597777|"     This is a randomized double-blinded study examining the effect of topical Acetyl     Hexapeptide-8 AH8) for improving the cosmetic appearance and experience of oily skin.   "
52545|NCT02597764|"     Urination is a result of a complex neuro-muscular coordination which involves the action and     arrangement of different parts of nervous systems as well as the muscular structure of the     lower part of the urinary system. When there is an abnormal pattern in bladder and bowel     habits without any known neuronal lesions, the condition is called bladder and bowel disorder     (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary accidents to     urinating much less than expected during the day.      The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a     beneficial basic and harmless form of treatment widely used for all children with BBD. SU     involves explaining of the problem to the children and their parents by the doctors and     educating them on proper voiding mechanisms, sitting, and standing positions as well as how     and when to void.      The purpose of this study is to explore the possibility of testing the additive effectiveness     of Diaphragmatic Breathing exercise (DB) as an alternative and harmless additional treatment     to SU in children with BBD.   "
52593|NCT02597127|"     This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 subjects     with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (eg, diabetes     and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of LDL-C     lowering therapies to evaluate the efficacy, safety, and tolerability of ALN PCSSC     injection(s).   "
52546|NCT02597751|"     Developmental coordination disorder (DCD) affects 5-6% of the school-age population, equating     to ~400,000 children, or 1-2 students in every Canadian classroom. Children with DCD find it     hard to learn motor skills and perform everyday activities, such as getting dressed, tying     shoelaces, using utensils, printing, riding a bicycle, or playing sports. Researchers and     clinicians do not know what causes DCD or why children with DCD struggle to learn motor     skills. Using MRI, this study will increase understanding of how the brain differs in     children with/without DCD and determine if rehabilitation can change the brain and improve     outcomes of children with the disorder.   "
52636|NCT02596568|"     This study will attempt to use a type of non-invasive brain stimulation technology during     sleep to improve measures of sleep quality and memory in young healthy students and older     adults. The type of brain stimulation is called transcranial direct current stimulation     (tDCS), which uses small currents of electricity to increase or decrease the activity of     specific areas of the brain.   "
52547|NCT02597738|"     The purpose of this study is to further advancements in biospecimens (blood cellular free     component, e.g., plasma, serum, tissue), in order to develop precision medicine, for lung     cancer management and lung cancer screening (synergy with imaging). A co-clinical trial     approach, with integrative analyses leveraging data from the treatment of genetic mouse     models of lung cancer along with clinical samples and data from lung cancer patients, will be     used to elucidate genomic background metrics, identify cell free DNA mutations, and further     refine the liquid biopsy approach.   "
52548|NCT02597725|"     The purpose of this study is to describe the urinary morbidity as a result surgery and     radiation therapy, in patients treated for prostate cancer.      All the patients will undergo a Urodynamic examination to verify the grade of Urinary     morbidity.   "
52549|NCT02597712|"     A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and     effective treatment in patients with Barrett's esophagus.   "
52550|NCT02597699|"     The feticide is a legal and ethical obligation during a termination of pregnancy after 22     weeks' gestation. This method raise concerns about the fetal pain, maternal complications and     the fetopathologic analysis. There are few studies on the subject. Investigators want to     evaluate a drug in order to facilitate this method technically and emotionally challenging.     They want to achieve a quick fetal asystole, a fetal analgesia, a maternal security and a     optimal fetopathologic analysis. A drug, remifentanil Ultiva®, seems could meet its     properties, it is a powerful morphine. A phase 2 clinical trial has assessed the feasibility,     efficacy and safety of Ultiva®. They had not been able to prove bradycardia or lethal effect     of Ultiva injected alone but the feasibility and safety were good.      Investigators want to set up a randomized clinical trial with 2 arms : Ultiva® and lidocaine     versus sufentanil and lidocaine (standard protocol), it is a bicentric study. The primary     outcome is the interval between the vascular injection of lidocaine and fetal asystole. The     secondary outcomes are the success rate of method, the number of puncture of the umbilical     cord, the maternal side effects and the quality of fetopathologic analysis.      The previous observational study showed a median interval of 2,3 minutes and a success rate     of 55% (lower interval to 2 minutes). From the results they calculate a necessary inclusions     to 66 patients.      They believe that the bradycardia property of Ultiva® allow a potentiation of the efficacy of     lidocaine. If the results are satisfactory, the use of Ultiva® can be generalized to other     fetal medicine team.   "
52551|NCT02597686|"     When the investigators are caught up in emotions, it is by stepping back (or decentering)     that the investigators are able to see the situation from another perspective. Individuals     with emotional disorders, however, can have difficulties in being able to do this.      Research has shown that improving an individual's ability to step back from their emotions     and take perspective is possible and can have beneficial effects on depressive symptomatology     (Self Distancing and Perspective Broadening [SDPB] training). The SDPB training package     involves two techniques: 1) stepping back from situations using mental imagery (building a     mental picture of the situation and changing the distance to it) and, 2) reframing situations     using perspective broadening reappraisals (giving new meanings to situations). The training     package trains these SDPB techniques using an individual's memories and every day events. The     fortnightly training comprises of two one to one sessions and daily homework for a week in     between.The SDPB training package is aimed at improving an individual's ability to step back     from, and put a new meaning to emotional events that take place in their lives.      The prospective pilot study aims to investigate whether the SDPB training package reduces     symptomatology and improves these abilities in individuals who experience both depressive and     manic episodes (Bipolar Disorder [BD]).      BD has a cumulative lifetime prevalence ranging from 1.52% across Europe and is treated with     moderate success using Cognitive Behavioural therapy (CBT). However, 'moderate success' is     considerably low compared to other mental health problems and CBT can be time time consuming,     expensive, and cognitively demanding (requiring a high level of functioning of one or more     cognitive functions). Accordingly, BD may be one of the emotional disorders in greatest need     of novel and evidence based treatments.   "
52552|NCT02597673|"     The overall objective of this project is to compare the three home-managed treatment regimens     for PFPS: neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve     stimulation (TENS), and NMES combined with TENS to a standard home exercise program (HEP).     Each of the three treatment arms will be supplemented by HEP and compared to a group     receiving standard HEP alone. The central hypothesis is that the combination of NMES with     TENS will show significantly greater improvements in muscle strength, mobility, pain, daily     activity and quality of life (QOL) than HEP alone.      The investigators are examining: 1) whether the three treatment regimens are significantly     more efficacious than standard HEP alone in improving lower extremity muscle strength,     physical activity, mobility, pain, and quality of life; 2) lower extremity muscle strength,     physical activity, mobility, pain, and quality of life differ significantly across the 4 time     periods; 3) is there an interaction between treatment and time in relation to lower extremity     muscle strength, physical activity, mobility, pain, and quality of life.   "
52553|NCT02597660|"     Patellar tendinopathy is one of the most frequent causes of non-traumatic knee pain and     reduced function in patients. Standard treatment options for patellar tendinopathies include     non-steroidal anti-inflammatory drugs, corticosteroids, cryotherapy, manual therapy,     eccentric exercises, and ultrasound. Unfortunately many patients fail to respond to these     therapies and return to normal activity levels, and recurrence rates for those who do respond     are unacceptably high. Many patients who fail to respond display persistent degenerative     changes on imaging studies suggesting a failure to regenerate the pathological tissue.     Developing new therapies that can directly promote the synthesis of new, healthy     extracellular matrix tissue could therefore address an important therapeutic need and make a     substantial improvement in our ability to effectively treat patellar tendinopathy and reduce     recurrence rates. Somatropin (human growth hormone of recombinant DNA origin) has been shown     to increase protein synthesis and matrix production when delivered directly into the tendon.     This study will evaluate the ability of somatropin to improve clinical outcomes and tissue     quality in patients with chronic tendinopathy.   "
53966|NCT02579200|"     The purpose of this study is to determine whether inspiratory muscle training is effective to     improve breathless and exercise intolerance in symptomatic patients with chronic obstructive     pulmonary disease (COPD) plus chronic heart failure (HF).   "
52578|NCT02597335|"     This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining     mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG     detection by Brain Spectro MRI.      In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery     will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor     mutational status and D-2HG.      In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma,     urine dosages overtime in order to correlate results with the response to treatment.   "
99634|NCT01981993|"     BACKGROUND:      Early diagnosis and prognostication of acute kidney injury in patients with sepsis is key to     further our understanding this disease and in the evaluation of new interventions for this     condition. Many urinary biomarkers have been proposed, but no single one seems to     consistently provide additional information on top of clinical and routine biochemical     parameters. Some authors have proposed to use a panel of urinary biomarkers to increase the     accuracy However, this approach has so far not been tested in a large group of patients with     sepsis. In addition, newer and more performant analytical techniques have been developed that     warrant testing in the clinical field.      PATIENTS AND METHODS:      At least 150 consecutive patients admitted to a tertiary care intensive care unit (ICU) with     sepsis will be included. After bladder catheterisation, urinary samples will be collected at     time points 0, 4 hours and 24 hours after admission, and further daily on day 1-5. Samples     will be immediately centrifuged and frozen at -80°C until analysis. Samples will be extracted     by removing larger proteins (>20kDa) and de-salting step prior to mass spectrometry analysis.     Investigators will use capillary electrophoresis-mass spectrometry (CE-MS) to assess urinary     peptides predictive of AKI: 20 peptides constituting the AKI marker pattern previously     established from a cohort of ICU patients. Simultaneously, samples will be analysed using     matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI-TOF MS),     an alternative platform to CE-MS, which is currently being developed for routine ICU use. A     proof of concept of the technique involved has been successfully applied to a set of urine     samples from patients diagnosed with diabetes presenting normoalbuminuria (controls) and     macroalbuminuria (cases).      Clinical, demographic and biochemical data of patients will be collected during the first 5     days.      PATIENT OUTCOME        -  in the short term:             -  development of acute kidney injury according to RIFLE criteria             -  death             -  need for renal replacement therapy during ICU stay        -  on the longer term             -  death             -  need for renal replacement therapy             -  estimated glomerular filtration rate as calculated by MDRD at 3 months, 1 year and               2 years.      Using cut-offs , Receiver Operating Characteristics curves, negative and positive predictive     value will be used to describe diagnostic performance of the biomarker panel alone, or in     combination with basic clinical and/or routine biochemical parameters. Univariate and     multivariate logistic regression for death will be used to evaluate prognostication value of     the biomarker set.      In addition, new discriminatory cut-offs of proteomic patterns as determined by more recent     proteomic analysis techniques will be determined in a training set (half of the cohort) and     validated in the other half of the cohort. Using the MALDI-TOF MS platform, investigators     will assess urinary peptides that were predictive of AKI in a training set (ca. 75 patients)     with good diagnostic performance of the marker panel (accuracy above 0.8) . Performance of     the biomarker panel will be assessed in a blinded test set of ca. 75 patients to evaluate     validity of the model in AKI detection.   "
52554|NCT02597647|"     This study will serve to determine how influenza infection alters the bacterial colonization     patterns in the nasal and oropharyngeal compartments, and whether the immune response     correlate with these alterations. The investigators will be determining bacterial composition     and immune responses in the nose and oropharynx during influenza infection.      Specific Aims      Therefore, the overall aims of this study are as follows:        1. To identify baseline composition and kinetic changes in the nasal and oropharyngeal          microflora and immune responses after administering intranasal live attenuated influenza          virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;        2. To identify nasal and oropharyngeal microbial composition and local immune responses          during influenza infections and after resolution of infection, and correlate these          changes with clinical outcomes.   "
52555|NCT02597634|"     This is a Phase 3, prospective, randomized, dual-center, double-blind, placebo-controlled,     parallel-group study designed to determine the efficacy and safety of SST-0225 (5.4 grams,     applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain     associated with DOMS.   "
52556|NCT02597621|"     Multi-center, observational, prospective cohort study including patients with     multidrug-resistant tuberculosis at different sites in Germany.      The aim the study is the identification of biomarkers for therapy response.   "
52557|NCT02597608|"     This is a randomized study in three areas of Bangladesh (Chars region where CLP operates,     Haor region where Shiree operates, and urban slums where UPPR operates). Treatment is     assigned at the community level, where treatments are:        -  Livelihoods intervention only (L only)        -  Livelihoods intervention plus nutrition intervention (L+N)      In UPPR only, the study also includes a non-randomly selected comparison group (C).      Within treatment localities, targeted beneficiaries include women, adolescent girls, and     children under 24 months. Benefits are received for two years.   "
52558|NCT02597595|"     The aim of this study is to evaluate the cardioprotective effect of spirulina in children     with beta thalassemia.   "
52559|NCT02597582|"     The aim of this prospective randomized study was to investigate if the LigaSure vessel     sealing system can reduce the operation duration and the postoperative drainage amount in     patients undergoing neck dissection.   "
52560|NCT02597569|"     Patients with cognitive impairments following a stroke are often denied access to inpatient     rehabilitation, despite evidence of its benefits for them. Patients with cognitive impairment     who are admitted to inpatient stroke rehabilitation often receive services based on outdated     impairment-reduction models, rather than recommended function-based approaches. These two     issues, reduced access to rehabilitation and the knowledge-to-practice gap, both stem from a     reported lack of skills and knowledge on the part of some stroke rehabilitation teams to     foster recovery in people with cognitive impairments. To address these issues, the     investigators will implement and evaluate a multi-faceted, supported, integrated knowledge     translation initiative, targeted specifically at the inter-professional application of the     Cognitive Orientation to daily Occupational Performance (CO-OP), called CO-OP KT. CO-OP is a     contemporary, effective, cognitive strategy-based treatment approach. CO-OP KT is a     combination of the CO-OP Approach with multi-faceted knowledge translation support. Clinical     staff at participating institutions will receive CO-OP KT training.      The long-term objective of CO-OP KT is to optimize functional outcomes for individuals with     stroke and cognitive impairments. Three specific research questions have been posed, one of     which is the focus of this registration. That sub study relates to patient outcomes following     the CO-OP KT training initiative and it will be addressed using a non-randomized design with     historical controls. Patient participants who enroll in the project prior to implementing the     CO-OP KT training will belong to the historical control group. Patient participants who     enroll in the project after the CO-OP KT training will belong to the CO-OP KT Exposure group.   "
52561|NCT02597556|"     Cheap and effective drugs called 'anthelmintics' are routinely administered to children in     developing countries to eliminate infections by parasitic helminths. However, the effects of     anthelmintic treatment on other pathogens (e.g., bacteria, viruses, protozoa) remain unknown.     The aim of this study is to investigate the impact of anthelmintic treatment on the incidence     of viral- and bacterial-induced diarrhea in school children in southern Vietnam. Diarrheal     disease remains a substantial cause of morbidity and mortality in children in Vietnam, and     these children are typically co-infected with intestinal helminths. As helminths and     diarrheal pathogens infect the same intestinal niche, anthelmintic treatments may alter host     immune responses and the composition of the gut microbiota in ways that affect infection and     disease risks caused by diarrheal pathogens.      This study will recruit 350 helminth-infected and 350 helminth-uninfected children aged 6-15     years. Recruited children will be randomized to receive either anthelmintic or placebo     treatment once every three months and will be monitored for incidences of diarrheal disease     for 12 months. At the 12-month time point, all children will receive anthelmintic treatment.     Blood and stool samples will be collected throughout the study and used for evaluation of     anemia and host immune responses, and for classification of gut microbes and parasite     detection, respectively. The interventional study proposed here will provide an important     first test of whether anthelmintic treatments have any indirect effects on infections caused     by diarrheal pathogens.   "
52562|NCT02597543|"     The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount     of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft     dysfunction in contrast to those with normal graft function. The investigators hypothesize     that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial     perfusion reserve, related to microvascular allograft vasculopathy, compared to those with     normal graft function.   "
52563|NCT02597530|"     To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS)     combined with general anesthetic during peri-operative could alleviate the dosage of     anesthetic drugs compared with control and sham group.   "
52594|NCT02597114|"     AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the     enzyme peripherally and to the brain, when administered intravenously. This study is an     extension of a safety and dose ranging study to obtain long term safety and exposure data, as     well as information on the biological activity of the investigational drug   "
62802|NCT02463617|"     This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).   "
52564|NCT02597517|"     Endoscopy is a tool that has greatly influenced gastroenterological diagnosis. However,     conventional endoscopy is limited to detecting lesions on the basis of gross morphological     changes and therefore a certainly diagnosis depends on biopsy sampling of macroscopically     obvious endoscopic features, or blind biopsy sampling of normal appearing mucosa with the     risk of missed pathology and sampling errors.      Gastric cancer is the second most common cause of cancer related death. One of the main roles     of upper gastrointestinal endoscopy is to identify gastric cancer at an early stage. The     importance of identifying H. pylori infection is because it plays a very important role in     gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis,     intestinal metaplasia, dysplasia and finally cancer. The importance of recognition a     precancerous gastric lesion is because we can detect most tumors at an early stage and     improve the survival.      Most studies conclude that it is difficult to diagnose H. pylori related gastritis and     gastric atrophy on the basis of endoscopic findings. Histology is therefore currently     considered to be the gold standard for detecting H. pylori infection. The reliability of     detecting H. pylori infection histologically depends on the site, number, and size of gastric     biopsy specimens, as well as on expertise in staining and visualizing the bacteria.     Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling,     and neither the original nor the revised version of the Sydney system reliably identifies     more than half the cases in patients with confirmed gastric atrophy.   "
52565|NCT02597504|"     This research study will evaluate a standalone software application and is designed to     standardize and validate new neurocognitive screening testing for children aged 6 through 11,     and adolescents and adults ages 12 through 75.      The purpose of this study is to evaluate recently developed computerized tasks sensitive to     changes in neurocognitive performance after a concussion. These tests were designed to help     measure the effects of concussion on cognitive processes (e.g., memory, attention, brain     speed) and visual functioning.   "
52566|NCT02597491|"     In this sequential, multiple assignment, randomized trial (SMART) current smokers who are     eligible for lung cancer screening will be identified using the electronic medical record at     the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8     weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible     for three potential randomizations during one year of smoking intervention: 1) to timing of     identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to     telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered     Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim),     and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line     treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence     measured 18 months after the beginning of treatment.   "
52567|NCT02597478|"     The goal of this clinical research study is to learn if fentanyl can help shortness of breath     in cancer patients. Researchers also want to learn if the study drug can help to improve your     physical function.   "
52568|NCT02597465|"     An open label study to determine the efficacy and safety of SPARC1507   "
52569|NCT02597452|"     The primary purpose of this study is to measure the clinical utility (accuracy) of the     hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results     will be compared to the results of a current mammogram and/or ultrasound. The duration of     study participation is approximately 30 minutes one day.   "
52570|NCT02597439|"     The purpose of this study is to determine whether omega-3 fatty acids are effective in the     prevention of psychosis in individuals at ultra-high risk for psychosis.   "
52571|NCT02597426|"     Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of     research in head and neck radiation oncology have largely focused on improvements in     survival, which have mostly come at the cost of long term toxicity for surviving patients.      This is an observational study that is being done to learn about the long-term symptoms and     side effects that survivors of nasopharyngeal cancer may have following radiation treatment.     This study will include assessment of patient report outcomes, physician-graded adverse     events, neurocognitive assessment and endocrine and hearing testing   "
52572|NCT02597413|"     The primary objective of this study is to evaluate the impact of systematic catheter-drainage     of urine for parturient women immediately in the delivery room on the occurrence of     post-voiding urine residue.   "
52573|NCT02597400|"     This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK     activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).   "
52574|NCT02597387|"     To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with diffuse     large B-cell lymphoma and lymphoma peripheral T cell.   "
52575|NCT02597374|"     To study the reactivity of the mu rhythm during action and action-observation by EEG in     children with unilateral cerebral injury.   "
52576|NCT02597361|"     This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome     (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their     vasculature affected by a defect in type III collagen in addition to the effects celiprolol.     This randomized, double blind, placebo controlled trial compares the administration of the     Ang II type I receptor blocker (ARB) — irbesartan— to placebo over a 2-year period in vEDS     patients with the main objective to reduce the incidence of both symptomatic and asymptomatic     vascular events.   "
52577|NCT02597348|"     This is a multicentric randomized parallel group open trial comparing 5-year survival of     chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with     confirmed unresectable liver-only metastases, well controlled by chemotherapy (no     progression) and extensively explored by modern imaging techniques. The primary objective of     the trial is to validate in a large multicentric cohort of selected patients the possibility     to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around     10% with chemotherapy alone.   "
52655|NCT02596321|"     To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as     change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with     ALK HDM tablets given once daily over 60 days.   "
54879|NCT02567305|"     This study is designed to assess the role of neutrophil extracellular traps (NETs) in     neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early     predictors of neonatal and pediatric sepsis.   "
52579|NCT02597322|"     Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial     growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in     phase II study in cytokine-refractory metastatic renal-cell cancer patients.      Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with     large organ confined tumors to benefit from NSS.      The Objective is to determine the efficacy of Axitinib administered prior to surgery in     patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for     shifting from a radical nephrectomy indication to a nephron sparing procedure.   "
52580|NCT02597309|"     The aim of this study is to evaluate the effect of adding a SGLT-2 inhibitor (namely     Canagliflozin) on the dose of U-500 insulin required to achieve glycemic control in patients     with type 2 diabetes. We hypothesize that adding Canagliflozin to patients treated with U-500     insulin may result in significant reduction in insulin dose due to improved insulin     sensitivity and weight loss.   "
52581|NCT02597283|"     This study is designed to test the hypothesis that the Biguard stent system will lead to     fewer target lesion failure compared to regular stent system in patients with coronary     bifurcation lesions at one year.   "
52582|NCT02597270|"     The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV)     NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or     previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the     frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are     associated with direct-acting antivirals (DAAs)-resistance.   "
52583|NCT02597257|"     The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the     Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.   "
52584|NCT02597244|"     Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South     Korea), was performed in patients who did not show improvement lasting more than 1 month     after diagnostic conventional fluoroscopically guided transforaminal epidural block with     local anesthetic and steroid.      Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris     Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the     procedure.   "
52585|NCT02597231|"     Recent data suggests that melatonin, a supplement available over the counter, may help     prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin     may help in delirium prevention by improving sleep quality and possibly circadian rhythm     cycling in patients who are given the supplement. This pilot study involves a randomized     placebo-controlled design in which participants will be randomized to receive either     melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with     wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep     questionnaire each morning to obtain subjective data on their sleep quality overnight.     Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method     (CAM).   "
52586|NCT02597218|"     Observational. Retrospective cohort.   "
52587|NCT02597205|"     The overarching goal of this program to increase the use of evidence-based,     secondary-prevention medications and promote healthy lifestyles among myocardial infarction     (MI) patients through using provider-facing mobile app and patients-facing text messages.   "
52588|NCT02597192|"     Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus     pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients     with generalized gingivitis.      Materials and methods: In this double-blind placebo-controlled randomized clinical trial     generalized gingivitis patients who were systemically healthy and who did not smoke were     included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8     weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary     outcome measures were pocket probing depth and bleeding on probing.   "
52589|NCT02597179|"     The purpose of this study is to investigate and analyse genomic profiles in patient with     breast cancer who failed standard treatment, refractory and young breast cancer.   "
52590|NCT02597166|"     There are now several licensed drug treatments for patients with HCV infection. These     medications have been shown to be very effective in getting rid of the virus in patients with     HCV infection including those with early stages of cirrhosis without complications known as     compensated cirrhosis, with a greater than 90% cure rate. At present, there are very little     data to show that treating patients with HCV infection and decompensated cirrhosis will give     the same effects. However, patients with decompensated cirrhosis as a result of hepatitis B     infection who received treatment to control their virus show improvement of their overall     liver condition, and the liver complications of many of these patients disappeared. Also,     patients with cirrhosis due to excess alcohol and who stopped drinking also showed     improvement in liver function and their complications of cirrhosis coming under control.     Therefore, treatment of patients with HCV infection and decompensated cirrhosis is expected     to show the same positive effects, because the underlying cause of cirrhosis is coming under     control. Harvoni is a combination of two direct-acting antivirals (ledipasvir and sofosbuvir)     that prevents the hepatitis C virus from copying and multiplying themselves, allowing the     body to clear the virus from their systems and be cured of HCV infection. This study is being     conducted to find out if treatment with Harvoni will lead to clearance of HCV infection in     patients with decompensated cirrhosis giving rise to improvement in liver function, together     with improvement of quality of life and survival.   "
52591|NCT02597153|"     To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed     cutaneous T cell lymphomasell   "
52592|NCT02597140|"     The purpose of this randomized pilot study is to evaluate the effect of intravenous lidocaine     on propofol requirement during BIS (Bispectral index) guided MAC (monitored anesthesia care)     in facial plastic surgery.   "
52622|NCT02596750|"     This study evaluates the role of microneedle pretreatment in the speed at which anesthesia     develops after application of topical 4% lidocaine.   "
52720|NCT02595476|"     A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in     a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and     BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml).     Pupillary reflex dilation is recorded after each stimulation.   "
52595|NCT02597101|"     The role of individual leukocyte populations in type 2 diabetes (T2D) and immunometabolism in     general represent important gaps in knowledge to better understand the etiopathogenesis of     T2D. Emerging evidence indicates that certain leukocyte populations serve as an important     nexus of T2D-associated inflammation. This novel and innovative clinical trial will test the     efficacy of a leukocyte-selective anti-inflammatory small drug as adjunctive therapy in     improving insulin sensitivity in obese, insulin-resistant type 2 diabetic subjects. This     trial also offers a first-in-kind opportunity to better understand the role of specific     leukocyte populations in type 2 diabetes. The drug's clinical profile suggests that it will     be well-tolerated with few, if any, side effects, and the existence of simple methods that     can indirectly measure its activity in vivo   "
52596|NCT02597088|"     Human milk (HM) is more than a food complex; in addition to micronutrients and human-coded     bioactive complexes it also includes many antioxidants, antibacterial, prebiotics,     probiotics, immune-boosting constituents, and many other bioactive components. Some of these     components may deteriorate during storage, and expressed EHM starts deteriorating as soon as     it leaves the breast. Nevertheless, whenever nursing at the breast or feeding of fresh EHM is     not possible, feeding of stored EHM is considered the next best thing to feeding at the     breast. Efficient heat transfer abilities affect both heating and cooling processes.      In this study the investigators wish to test a new device that permits rapid heating and     cooling processes. The investigators plan to measure some thermolabile constituents of HM in     order to determine whether they might be protected by a more gentle warming process. The     investigators plan to collect milk from mother, to mix it and to test the effect of storage     and heating.      This experiment is design to test the feasibility and the efficiency of the device.   "
52597|NCT02597075|"     The purpose of this study is to assess whether a structured physical activity program (PA)     during palliative chemotherapy improves progression-free survival (PFS) and/or     patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.   "
52598|NCT02597062|"     The purpose of this study is to find out what effects carfilzomib has on relapsed multiple     myeloma when administered in combination with cyclophosphamide and dexamethasone.   "
52599|NCT02597049|"     The main purpose of this study is to evaluate the efficacy and safety of the study drug known     as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in     participants with type 2 diabetes mellitus.   "
52601|NCT02597023|"     The purpose of this study is to assess the efficacy of supplementation with the     mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function     (vascular, motor, and cognitive) in middle-aged and older adults.   "
52602|NCT02597010|"     Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic     blood pressure in multiple populations including newly diagnosed, untreated hypertensives.     The additional effect in hypertensives on blood pressure lowering medications is uncertain.   "
52603|NCT02596997|"     Provide patients with serious AdV infection or disease access to treatment with BCV.   "
52604|NCT02596984|"     Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and     patients, only a few studies have been performed in critically-ill patients. In these     patients several factors, including sepsis, shock, increased distribution volume, hepatic     dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations     and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from     case series or animal studies. Thus, studies performed so far show Caspofungin trough     concentrations either decreased, similar to usual value in non-critically ill patients or     increased. One of these studies suggested that body weight and hypoalbuminemia may be the     main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic     parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of     distribution of caspofungin and intercompartmental clearance to be higher than in healthy     animals. These results are however preliminary and cannot be extrapolated suggesting further     clinical studies in human to be needed.      The primary objective of this study is to assess Caspofungin trough concentrations and     pharmacokinetics in critically-ill patients requiring vasopressors.   "
52605|NCT02596971|"     This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety,     efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in     combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP     (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy     (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting of     either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a     complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab     alone in participants with DLBCL who achieve a CR at EOI.   "
52606|NCT02596958|"     The purpose of this non-interventional study is the collection and documentation of data on     safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based     chemotherapy for first-line treatment in participants with unresectable advanced, metastatic     or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell     histology with focus on adenocarcinoma and elderly patients in daily routine.   "
52607|NCT02596945|"     This non-interventional, observational study investigates the efficacy, safety and usability     of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis.     Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and     who meet the selection criteria were to be enrolled and documented in this study for a period     of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to     efficacy, safety and usability.   "
52680|NCT02595996|"     This is a study to investigate the safety and efficacy of propranolol in the treatment of     patients with primary lymphedema. The primary goal is to assess patient tolerability of     increasing doses of propranolol. The secondary goal is to assess lymphedema symptoms and     signs in response to propranolol treatment.   "
52635|NCT02596581|"     The aims of the present study were to determine the gingival crevicular fluid (GCF) chemerin     and interleukin-6 (IL-6) levels and to analyse the relationship between chemerin and IL-6 in     periodontal health and in chronic periodontitis (CP) with and without type 2 diabetes     mellitus (T2DM) as well as to evaluate the effect of non-surgical periodontal therapy on the     GCF chemerin levels.   "
52608|NCT02596932|"     Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of     pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born     to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal     glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in     how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there     is a paucity of data guiding practitioners in the intrapartum management of blood glucose     levels for women with GDM, particularly those treated with insulin antepartum. The goal of     this project is to compare two protocols of intrapartum glucose management in women with GDM     and investigate the impact on neonatal blood glucose levels.   "
52609|NCT02596919|"     Infrared meibography is a useful technique in the evaluation of meibomian gland disease     (MGD). MGD is a major cause of dry eye symptoms, affecting a large number of patients seen in     the Corneo-Plastic Unit (CPU). Many parameters have been used to evaluate MGD including tear     film break-up time, lid margin abnormalities, and Schirmer tear test values. Direct     visualization of meibomian glands by infrared meibography has been shown to correlate well     with these parameters.      Although infrared meibography was developed more than 30 years ago, it is not widely used.     This has probably been due to the need for special equipment, examiner time and expertise and     patient discomfort during the examination. Analysis of the acquired images also needed to be     from video review with extraction of video stills - a time-consuming process.      Investigators aim to pilot a rapid non-contact (non-painful) method of obtaining infrared     images of meibomian glands using equipment already available at QVH. This pilot study will     validate the technique and check patient acceptability. Investigators are hopeful this test     could be used as a useful tool for future research into dry eye conditions and MGD.   "
52610|NCT02596906|"     Individuals aged 55 and older may experience negative effects of cognitive decline. The     proposed research seeks to evaluate the benefits of different types of interventions:     reasoning training following transcranial direct current stimulation (tDCS) and reasoning     training following sham transcranial direct current stimulation (tDCS) on frontal- lobe     mediated cognitive measures of executive control in adults with memory complaints, in the     absence of dementia.   "
52612|NCT02596880|"     The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir     400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200     mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral     response rate at 12 weeks.   "
52613|NCT02596867|"     This trial is a Phase II study using the window-of-opportunity design in which the     treatment-free window between breast cancer diagnosis and surgical tumor resection is used to     study the biological effects of the beta blocker propranolol .   "
52614|NCT02596854|"     This study is being conducted for regulatory submission of the GE Healthcare MAGnetic     resonance Image Compilation (MAGiC), a point-of-care synthetic MR reconstruction software for     GE 1.5T and 3.0T MR scanners.   "
52615|NCT02596841|"     The diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography (CT)     imaging, whereas lung function studies are used for staging and follow up. Lung diffusing     capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated with the     severity of CT-determined fibrotic process. A possible explanation of this finding is that     DLCO is relatively insensitive to changes in alveolar membrane diffusive conductance (DMCO).     Lung diffusion capacity for nitric oxide (DLNO) was strongly correlated with CT-determined     amount of fibrosis/honeycombing in both usual and non-specific interstitial pneumonias.     Moreover. Both DLNO and DMCO were below the lower limit of normality even in patients with     small amount of fibrosis. Measurement of DLNO may provide a more reliable assessment of     fibrotic changes than DLCO because it better reflects DMCO.   "
52616|NCT02596828|"     Children, adolescents and young adults with relapsed or treatment refractory pineoblastoma     (rPB) represent a group of patients with dismal prognosis for whom a recommended standard     salvage therapy is currently not available.   "
52617|NCT02596815|"     The purpose of these study is to compare the effectivity of the Median Nerve Neural     Mobilization technique to the complete absence of treatment in a group of patients who suffer     cervicobrachial pain.   "
52618|NCT02596802|"     The goal is to study the feasibility and safety of implementing Fetoscopic Endoluminal     Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia     (CDH). The pilot study will determine whether FETO therapy can be performed safely and     whether it can increase survival and decrease morbidity when compared to standard prenatal     care for the treatment of severe left CDH.   "
52619|NCT02596789|"     This study has two main goals :        -  to investigate the impact of aging on cortical excitability (CE)        -  to investigate the impact of state dependency on CE, using a cognitive task and an          emotional one.      A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic     response are recorded.   "
52620|NCT02596776|"     An adaptation to a cold environment is a tendency to generate heat within our body. Some of     this heat comes from our fat tissue. Although most fat tissue is white fat, there are     pockets deep within the body that are called brown fat, which are specially adapted to     burning fat and making heat. The investigator believes that our white fat, just underneath     the surface of our skin, also has this property to burn fat and make heat, although not at     the high level of brown fat. This study is to examine this fat-burning property of the white     fat under the skin in response to seasons and to cold. Many such studies have been done in     mice, but little has been done in humans.      There are a number of factors, including age, weight, and medical history, that may make a     person eligible or ineligible to participate in this study. Certain medications could make a     person ineligible, but if these medications can be safely altered, the individual may become     eligible.   "
52621|NCT02596763|"     BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions     (Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring of     792 patients during their first year of baclofen prescription for alcohol use disorder.      The main objective of the study is to determine the rate of patients who stop baclofen due to     an adverse event (AE) in the first year of treatment.The BACLOPHONE study also aims to     determine which types of AEs and serious AEs are actually liable to baclofen, and which other     types are more likely the consequence of confounding factors, e.g., concomitant alcohol,     psychotropic medications or substance uses, and comorbidities.   "
52623|NCT02596737|"     Individuals spend one third of their life working. Age of retirement is regularly pushed     back. The main challenge in the nearest future will be to maintain workers health to deal     with their work till retirement. Morbidity before retirement has a huge cost, both in public     health and economically for companies. Numerous factors increase morbidity such as stress at     work, sedentary and low physical activity, and poor nutrition habits. Nowadays, digital world     wildly invades lives and offer a no-limit possibility to interact with individuals,     everywhere. Thus, a software able to understand an individual in its globality seems to     address this challenge. Moreover, managers need to understand the actions needed within their     company. The objective of WittyFit is to increase life expectancy and well-being. WittyFit     will constitute a powerful database to build strong evidence and new knowledge on the     relationships between work, behavior, and health, based on a large amount of epidemiological     data.   "
52624|NCT02596724|"     Prospective observational registry that links results of the genomic and other molecular     testing to treatment response and survival measures in patients who have been diagnosed with     breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests     impact treatment decisions and outcomes.   "
52625|NCT02596711|"     The goal of this research study is to learn how 3 different kinds of counseling treatments     may help individuals to quit smoking.   "
52626|NCT02596698|"     This study consists of three separate appointments including a clinical assessment (interview     and questionnaires), a blood draw, a social stress test, and a brain MRI.   "
52627|NCT02596685|"     This randomized pilot clinical trial studies the effects of electronic cigarettes on the     lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and     Drug Administration (FDA) and other government regulators with important information, which     may help in developing future regulations to make electronic cigarettes safer.   "
52628|NCT02596672|"     The multi-level 12 week peer-led walking intervention incorporates aspects from all three     levels of the ecological model (with the aim of producing sustained (>6months) physical     activity behaviour change in older adults living in independent living communities.   "
52629|NCT02596659|"     Background:      Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion     site of common extensor tendon to humerus. It is usually related to overuse of local muscle.     Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It     applies shockwave energy to the lesion site, enhancing the growth of microvascularity,     inducing tissue repair, and thus relieving the symptom.      The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.      Material and Methods        -  Subjects: 30 patients will be recruited from outpatient department of physical medicine          and rehabilitation department.        -  Duration: 2013.09.01-2015.05.31        -  Methods: The patients will be randomly divided into the experimental group and the          control group through the draw, with 15 patients in each group. Patients in the          experimental group receive rESWT plus routine rehabilitation program. Patients in the          control group receive sham shockwave therapy plus routine rehabilitation program.        -  Assessment: Before the therapy starts, patients who match the inclusion criteria will be          evaluated using tools mentioned below:        -  General data: age, sex, body height, body weight, affected side, medical history        -  Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and          Hand Questionnaire (DASH)        -  Assess severity of pain with Visual Analogue Scale (VAS)        -  Assess grip strength with grip strength dynamometer        -  Measure the size of tear (if any) of common extensor tendon through ultrasonography, and          assess the texture of common extensor tendon through real-time sonoelastography (RTS)      Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will     be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and     presentation on ultrasonography and RTS.   "
52630|NCT02596646|"     This study evaluates whether an early precut strategy in cases of difficult biliary     cannulation could reduce the incidence of PEP compared with that after prolonged cannulation     attempts. Secondary aims are to compare the success of biliary cannulation and complications     rates of the two techniques.   "
52631|NCT02596633|"     This study will investigate the feasibility of running a randomised controlled trial (RCT) of     a psychotherapy called Acceptance and Commitment Therapy (ACT), delivered in a self-help     format with additional telephone support from a therapist, for people with Multiple Sclerosis     (MS) and low mood.   "
52632|NCT02596620|"     Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative     second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth     salts are not available. The investigators compare the efficacies of 10-day     levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients     after failure of standard triple therapy and to determine what clinical and bacterial factors     influencing the efficacy of salvage regimens.   "
52633|NCT02596607|"     Acute stroke management represents a true medical emergency that requires prompt diagnosis     and urgent treatment. However, only a small percentage of patients access to thrombolysis on     time. Various actions have been implemented since 2006 in the Rhone area as part of research     projects and of the 2010-2014 national stroke action plan: training of health professionals     involved in the stroke management, increase of public awareness through sensibilization     campaigns, implementation of telemedicine and increase of the number of hospital beds     dedicated to stroke (stroke units beds).      The main objective of the STROKE 69 study is to assess the impact of these actions on     intra-hospital acute stroke management times in the Rhône area. The secondary objectives are     to assess the impact of these actions on the rate and place of thrombolysis, the rate of     post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3     and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of     calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and     management channels.      The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016     and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort     study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and     06/06/2007, before the implementation of the actions in the Rhône area.      The cohort will be constituted of all consecutive patients treated for a stroke suspicion by     the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area,     and presenting a symptom-onset (the last time the patient was seen without deficit) less than     24 hours.      After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or     transient ischemic attack (TIA) will be followed for 12 months after their inclusion by     telephone calls at 3 and 12 months to assess the level of disability and mortality.      AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan     to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed     strokes or TIAs.   "
52634|NCT02596594|"     Placental insufficiency is responsible for fetal loss in about 40% of all stillbirths and     long term neurological deficits. The mean interval from diagnosis of brain sparing of severe     IUGR fetuses to delivery has been recently identified by only seven days (Flood K et al, Am J     Obstetrics and Gynecology 2014).      The critical placental player in the active amino acids (AA) transport from the mother to the     fetus is the trophoblast, which is irreversibly changed in severe IUGR fetuses caused by     placental insufficiency. Thus, a logical partial solution of IUGR could be the direct supply     of AAs and glucose to the fetus, in order to improve the fetal growth, normalize the fetal     programming and to prolong the pregnancy.      The aim of this prospective pilot study is to further test the efficacy of the administration     of AAs and glucose supplementation with hyperbaric oxygenation (HBO), via a subcutaneously     implanted intraumbilical perinatal port system, as a treatment option for severe IUGR human     fetuses with brain sparing.   "
52637|NCT02596555|"     This prospective, multicenter, multinational, phase IV, interventional single-armed     (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral     anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated     imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels     of cardiac troponins and natriuretic peptides) parameters and their combinations.   "
52638|NCT02596542|"     Cold-water immersion (CWI) is a frequently applied strategy to accelerate post-exercise     recovery in both recreational as well as professional athletes. However, the effect of     repeated post-exercise CWI on other recovery strategies remains unclear.   "
52639|NCT02596529|"     The optimal treatment of ankle fractures with involvement of the posterior malleolus remains     a subject of debate. Despite a large amount of literature on the role of the posterior     malleolus in a so-called trimalleolar fracture, there are no clear guidelines for its     treatment. Its size is the leading indication whether fixation of the fragment is necessary     or not. Most orthopedic surgeons consider a posterior malleolar fracture fragment larger than     25% to 33% an indication for fixation. Interestingly, after careful evaluation of the     available literature, there does not seem to be hard evidence for these numbers. It is     generally accepted that restoration of a normal anatomic mortise and normal tibiotalar     contact area are key elements for a good functional outcome. Inadequate reduction of the     posterior fragment may alter the tibiotalar contact area and the joint biomechanics with     altered stresses in parts of the joint, leading to the development of osteoarthritis and     worse functional outcome. Traditionally, reduction of these larger fragments is indirectly,     followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are     that it is hard to achieve an anatomical reduction, and that fixation of smaller fragments is     very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral     approach in prone position, followed by open reduction and fixation with screws in     posterior-anterior direction or antiglide plate is advocated by several authors. This     approach allows perfect visualization of the fracture, articular anatomical reduction, and     strong fixation. Another advantage is that even small posterior fragments can be addressed.     Several case series are published, which describe minimal major wound complications, good     functional outcomes, and minimal need for reoperation. Since 2 years, in our institution we     perform an open, anatomical reduction and fixation of all medium-sized posterior fragments     via this approach. Although not thoroughly investigated yet, it seems to lead to better     clinical outcomes than described in the literature and our retrospective cohort study.   "
52640|NCT02596516|"     The aim of this study is to evaluate whether there is a difference in the bile acid content     in the bowel in patients after right versus left colectomy. There is compelling evidence that     patients under going resection of the right colon versus left coolon have a lower polyp     detection rate in surveillance colonoscopies. The investigators intend to evaluate feces of     patients undergoing left and right colectomies; prior to their surgery and again three and     six months aftet the surgery. The investigators plan to compare the content of the different     bile acids and to compare the content between the two groups.   "
52641|NCT02596503|"     This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of eribulin     in combination with fixed doses of oral irinotecan in adolescents and young adults with     relapsed or refractory solid tumors. Eribulin will be administered intravenously on days 1     and 8 of a 21-day cycle, while irinotecan will be administered orally on days 1-5.      Patients will be assigned an eribulin dose level at the time of enrollment using a 3+3 Phase     I design, and there will be no intrapatient dose escalation. Once the RP2D has been     established, there will be up to 10 patients enrolled in a dose expansion cohort. In absence     of disease progression or toxicity, subjects may receive up to 17 cycles of therapy.   "
52642|NCT02596490|"     Objectives:      Our specific aims are to:      Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with     metastatic lung cancer and their partners.      Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and     their partners regarding physical, psychological, and spiritual quality of life outcomes.      Exploratory Aim: Explore potential intervention mediators (i.e., mindfulness, compassion,     holding back, and intimacy) and a moderator (i.e., baseline distress) of the intervention     effects.   "
52643|NCT02596477|"     The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical     marker and functional benefit to damaged heart muscle cells. This will be evaluated by     measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In     addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure     will be evaluated.   "
52667|NCT02596165|"     The significance of parameters of the central hemodynamic is based upon their strong     association with left ventricular hypertrophy and target organ damage at the heart.     Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the     central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly     promising potential for research and daily clinical praxis for improved cardiovascular risk     assessment on the population level. The purpose of this study is to evaluate the validity of     the central and peripheral blood pressure and central arterial stiffness measured with the     device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland).   "
64308|NCT02443922|"     A multi-year clinical study to improve tools for measuring the function of insulin-producing     beta cells in people with type 2 diabetes mellitus.   "
52644|NCT02595424|"     This randomized phase II trial studies how well temozolomide and capecitabine work compared     to standard treatment with cisplatin or carboplatin and etoposide in treating patients with     neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other     parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy,     such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may     respond better to treatments other than the current standard treatment of cisplatin and     etoposide. It is not yet known whether temozolomide and capecitabine may work better than     cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine     carcinoma, called non-small cell neuroendocrine carcinoma.   "
52645|NCT02596451|"     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site     Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark     Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer     Health, Inc) in Patients with Osteoarthritis (OA) of the Knee   "
52646|NCT02596438|"     The Thousand Asian American Study or TAAS aims to test 2,000 foreign-born and children of     foreign born Asian Americans residing in Sacramento county residents for HBV and (2) counsel     at least 90% of those whose screening results are positive for HBV.   "
52647|NCT02596425|"     The aim of this clinical trial is to evaluate the efficacy and safety of different     recruitment maneuvers for reducing postlaparoscopic shoulder pain.   "
52648|NCT02596412|"     Children with cerebral palsy may benefit from treatment with botulinum toxin injections to     decrease spasticity for improve function and quality of life. These injections cause repeated     pain throughout childhood and may be the cause of post-traumatic stress despite drug and     non-drug pain management. The Mini-Docs project of the French Red Cross has a module based on     a digital device with augmented reality. Distracting the child, the use of this module on a     tablet would reduce pain felt during botulinum toxin injections.   "
52649|NCT02596399|"     This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study     in healthy volunteers, enrolled at a single site in the United States to investigate the     safety, tolerability, and pharmacokinetics of DSTA4637S.   "
52650|NCT02596386|"     Dialysis patients typically undergo 3 treatments a week every other day with an almost 3 day     gap during the weekend. After this gap and before the first dialysis of the week the serum     Potassium level is expected to be maximal.      Participants will be recruited from the dialysis clinic at Hadassah Ein Kerem Hospital. The     research team would personally meet the patients who answer inclusion criteria f and ask     whether they wish to participate.      Each willing participant will undergo Sialometry and blood will be drawn from the dialysis     connections for CBC and Biochemistry to establish a baseline.      The study measurements namely Sialometry and collection of Saliva as well as blood test will     be taken before the initiation of the dialysis.      Blood testing will be done via the laboratories of the Hadassah hospital. Saliva analysis     will be done in the research lab of Prof. Doron Aframian.   "
52651|NCT02596373|"     The hypothesis of this clinical research study is to discover if the study drug Mitoxantrone     Hydrochloride Liposome Injection can shrink or slow the growth of advanced recurrent or     metastatic breast cancer   "
52652|NCT02596360|"     The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in     healthy volunteers compared to placebo.   "
52653|NCT02596347|"     Current studies suggest that alveolar macrophages (AM) act as silencers of most immune     responses in the lung. However, in pathological conditions, such as asthma, hypersensitivity     pneumonitis, and sarcoidosis, AMs become involved in the maintenance and further expansion of     the immune response in the target organ. The Investigator has preliminary data demonstrating     that CBD AMs at the site of disease involvement (bronchoalveolar lavage, BAL) display an     activated cell surface phenotype compared to AMs from healthy controls. Furthermore, exciting     data from our group demonstrates significant differences in gene expression profiles between     CBD and Beryllium Sensitivity (BeS) bronchial alveolar lavage (BAL) cells, in pivotal immune     response genes and networks. Specifically, the Investigator has found the JAK/STAT pathway     and the JAK2 gene was dramatically overexpressed in CBD BAL cells. In addition,     constitutively phosphorylated JAK2 (pJAK2) was found in AMs from Chronic Beryllium Disease     (CBD) patients by Westernblot and was increased after beryllium (Be) stimulation for 30 min.     Moreover, the JAK2 inhibitor TG101348 significantly inhibited Be-induced CBD AMs TNFa and     IFNy production. Meanwhile, overexpression of the JAK2 inhibitor SOCS 1 (suppressors of     cytokine signaling) protein decreased Be-induced TNFa production from AMs. Based on this     information, the Investigator hypothesizes that CBD AMs overexpress JAK2, which augments the     immune response to Be and development of CBD but not BeS.      The investigators believe that these studies are highly innovative since they will     undoubtedly shed light on exposure-mediated immune dysregulation in Alveolar Macrophages     (AMs) that lead to disease development and likely progression and with additional study of     this pathway will reveal potential biomarkers for clinical prognosis and diagnosis. The     results obtained from this study will improve the investigators understanding of factors     involved in the development of Chronic Beryllium disease (CBD), as well as define targets for     therapy, and will serve as a model of other exposure-related immune responses and     environmentally-induced chronic diseases. Most importantly, these studies will provide the     investigator with preliminary data to submit a high quality R01, allowing the Investigator to     apply similar approaches to other genes, define a potential target for this and other similar     immune-mediated diseases and continue research efforts at National Jewish Health (NJH.)   "
52654|NCT02596334|"     Triple antiretroviral regimens have greatly improved the prognosis of patients living with     HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have     a life expectancy close or equal to that of people not infected with HIV.[1] However, this is     under the condition of a lifetime maintenance of an undetectable plasma viral load (pVL)     (<50 cp/ml). On the other hand it is well established that aging increases comorbidities     among PLHIV and the burden of co-medications.[2] This also has the consequence of frequent     drug-drug interactions. In this context it is important to decrease pills burden,     side-effects and drug-drug interactions, while maintaining undetectability.      Currently, there is a strong interest for medical research to validate lightened regimens     (i.e. bithérapies [3-7] and monothérapies [8,9], particularly in a maintenance strategy, with     the primary objective of reducing burden of pills and side effects. Several monotherapy     trials using a boosted protease inhibitor (PI/r) showed high level of viral suppression, even     if this proportion was not always non-inferior to maintaining a triple therapy. [8,9]     Fortunately, when virological failure occurred under monotherapy virologic suppression was     easily restored by the addition of two NRTI. Patients who are most likely to maintain viral     suppression under a reduced scheme are those that have a high nadir (> 100 CD4 / mm3), no     previous AIDS event and a sustained virologic suppression (>12 months).      Monotherapy is the option that best reduces the burden of pills and the risk of side effects     or drug-drug interactions. It must be considered using very powerful molecule that harbor a     strong binding to its ligand in order to minimize the risk of selecting resistant mutants in     the case of virologic failure. To be as simple as possible in its use, it must be a single     agent administered as a single dose once a day and not boosted if possible. The molecule must     have very good tolerance. Finally, to be effective in viral sanctuaries this molecule should     have a good (or sufficient) diffusion to ensure effective Cmin on wild viral strains.     Dolutegravir meets all these exigences.[10] In addition, our team recently presented results     of a pilot study showing that the switch of a successful combined antiretroviral regimen to     dolutegravir monotherapy maintained undetectable viral load (<20 cp/ml) after a median of 7     months (range 6.5-10 months).   "
52656|NCT02596308|"     Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis.     Pneumonic plague is typically diagnosed in humans with high mortality. It has a long history     for plague as an agent of biowarfare, and poses a serious threat to international security.     Althought the killed whole-cell plague vaccine and live attenuated vaccine have been     licensed, they are rarely used today because of toxicities, limited evidence for efficacy to     prevent plague, and limited commercial availability. In the last twenty years,the recombinant     subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as     the main composition have caused widely attention with providing greater protection than     vaccines comprised of either subunit alone. This study was aimed to explor the safety and     immunogenicity of a new type plague subunit vaccine which comprised natural F1 antigen and     recombined V antigen (F1+rV).   "
52657|NCT02596295|"     The study will collect human milk from 100 mother of term infants 2-3m after delivery and     from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be     analysed and statistical analysis will look at correlation between demographics, dietary     habits and milk composition.   "
52670|NCT02596126|"     The purpose of this study is to evaluate the efficacy of a polypill strategy containing     aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the     standard of care (usual care according to the local clinical practices at each participating     country) in secondary prevention of major cardiovascular events (cardiovascular death,     nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in     elderly patients with a recent myocardial infarction.   "
52658|NCT02596282|"     Background: Medical male circumcision (MMC) for HIV prevention is a priority in 14 East and     Southern African countries, and the long-term sustainability of MMC programs could best be     achieved by early infant male circumcision (EIMC.) However, the acceptability and safety of     EIMC provided by non-physicians is unknown.      Methods: We conducted a trial of EIMC using the Mogen clamp provided by newly trained     clinical officers (CO) and nurse midwives (NMWs) in 4 health centers in rural Rakai, Uganda.     501 healthy neonates aged 1-28 days with normal birth weight and gestational age were     randomized to CO (n=256) and NMWs (n=245), and were followed up at 24 hours, 7 and 28 days.     Combined analgesia was provided by paracetamol suppository, Eutectic Mixture of Local     Anesthetics (EMLA) cream and a 24% sucrose solution.   "
52659|NCT02596269|"     BACKGROUND : There has been increasing interest on the use of nefopam in i.v.     patient-controlled analgesia (PCA).      OBJECTIVE : The aim of this study was to evaluate the opioid-sparing effect of nefopam, when     administered via i.v. PCA with fentanyl, after laparotomy. The adverse events associated with     its use were also evaluated, and specific considerations in its clinical use were reviewed.      DESIGN : A randomized, controlled, single-centre, double-blinded study.      SETTING : One Korean university hospital.      PATIENTS : Seventy-one patients planned for elective open laparotomy      INTERVENTIONS : Patients were assigned into SF (control) or NF group, who received IV PCA     with fentanyl in normal saline (25 µg/ml), or a solution with 120 mg of nefopam included     (fentanyl 25 µg/ml and nefopam 1.2 mg/ml), respectively.      MAIN OUTCOME MEASURES : The pain intensity during the 24 h study period and patient     satisfaction at the end of the study were evaluated. Adverse events were observed.   "
52660|NCT02596256|"     Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric cancer.   "
52661|NCT02596243|"     The purpose of this study is to access the efficacy and safety of GX-188E according the     protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)   "
52662|NCT02596230|"     RE-COVERY is a large, multi-national, multi-center observational study based on new data     collection. The study will enroll and characterize patients within 30 days of being diagnosed     with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize     the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for     cross-sectional characterization of the VTE patient population. Objective 2 will compare the     safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison     to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for     the occurrence of outcome events for up to one year.   "
52663|NCT02596217|"     Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab)     in healthy Chinese, Japanese and Caucasian male volunteers.   "
52664|NCT02596204|"     With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for     frequent and timely monitoring is now feasible. The investigators propose to leverage this     new technology to provide children and families with appropriate interventions to help manage     their diabetes.   "
52665|NCT02596191|"     This is a 2-year follow-up study of a cohort of 60 CMT1A patients. The objective is to     identify markers allowing to better understand the phenotypic variability observed on     patients with CMT1A, to identify predictive markers of the disease's progression and to     provide validated measurement tools that can be used as outcome measures in future clinical     trials.   "
52666|NCT02596178|"     Lung units that participate in gas exchange are known as 'recruited' lung. Patients with lung     injury suffer from a proportion of units that do not participate in gas exchange (i.e. the     derecruited lung), which results in impaired gas exchange and induces an inflammatory     cascade. The level of PEEP is often coupled to indices of oxygenation such as PaO2, PaO2 to     FIO2 ratio, or oxygen index. Currently, two strategies are widely accepted and considered     equivocal, one strategy using a lower PEEP level coupled to a certain oxygen requirement, the     other using a higher PEEP level.      The primary purpose of this study is to demonstrate the safety and efficacy of an electrical     impedance tomography (EIT) PEEP titration protocol designed to recruit collapsed lung in     children with ARDS and properly maintain lung volumes by setting an optimal PEEP level. A     safety system has been developed using the ARDSnet FIO2/PEEP High (upper threshold limit) and     Low (lower threshold limit) algorithm. Efficacy will be defined as an improvement in lung     volume as assessed by electrical impedance tomography, lung compliance and by an improvement     in markers of gas exchange. Safety will be defined as the incidence of barotrauma and     hemodynamic consequences that occur during the protocol. Those results will be compared to     incidences of barotrauma and hemodynamic compromise within the ARDS literature. Knowledge     gained from this pilot will be instrumental in developing an EIT imagine guided protocol     which will allow us to conduct future RCTs utilizing EIT technology   "
52668|NCT02596152|"     The effects of mini-trampoline training on balance, cardiorespiratory fitness, strength and     neuropsychological parameters in an overweight or obese population are unknown. The aim of     this 2-arm randomized controlled trial is to compare the effects of a 12-week mini-trampoline     training and a 12-week nordic walking training on balance, fitness and strength in     overweight/obese individuals.   "
64309|NCT02443909|"     To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm     diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).   "
52669|NCT02596139|"     The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to     measure fatigue. It covers the following dimensions: general fatigue, physical fatigue,     mental fatigue, reduced motivation and reduced activity.      Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue     symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and     -FSS- to Taiwan-version, and to examine the reliability and validity of the scales.      A hundred adult people without diagnosed physical nor mental disabilities will be recruited.     Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality     Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later     to evaluate the test-retest reliability.      Another twenty people who are familiar with both English and Chinese will be recruited to     evaluate the translation reliability. Subjects will fill out the English version of MFI and     FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes     apart. The translation reliability will be evaluated by paired t test and the intraclass     correlation coefficient.   "
52671|NCT02596113|"     The investigators designed a prospective study to evaluate the predictive ability of     detection of mutations in genes involved in carcinogenesis of the colon (eg hMLH1, K-Ras,     B-Raf, ccfDNA) in a sample of Greek population presents for conducting colonoscopy in the     context of screening under international CRC prevention instructions. This investigation will     be carried out in individuals in normal risk in order to study specific mutations (in blood     and tissue) to draw reliable conclusions about whether we can detect (with greater     sensitivity and specificity) patients with precancerous lesions or CRC with a simple blood     test thereby reducing the cost and side effects of repeated endoscopic procedures.   "
52672|NCT02596100|"     This is a single center open label randomized 4-period 2-sequence replicated crossover design     study. A total of 52 healthy subjects will be randomized.   "
52673|NCT02596087|"     The overall goal of the IQ-MAPLE project is to improve the quality of care provided to     patients with several heart, lung and blood conditions by facilitating more accurate and     complete problem list documentation. In the first aim, the investigators will design and     validate a series of problem inference algorithms, using rule-based techniques on structured     data in the electronic health record (EHR) and natural language processing on unstructured     data. Both of these techniques will yield candidate problems that the patient is likely to     have, and the results will be integrated. In Aim 2, the investigators will design clinical     decision support interventions in the EHRs of the four study sites to alert physicians when a     candidate problem is detected that is missing from the patient's problem list - the clinician     will then be able to accept the alert and add the problem, override the alert, or ignore it     entirely. In Aim 3, the investigators will conduct a randomized trial and evaluate the effect     of the problem list alert on three endpoints: alert acceptance, problem list addition rate     and clinical quality.   "
52674|NCT02596074|"     To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001)     in patients with usual type vulvar intraepithelial neoplasia (uVIN).   "
52675|NCT02596061|"     This study aims to examine whether a combination of positive and negative commitment devices     is effective at inducing long-term smoking cessation in smokers from a low-to-moderate income     background. Investigators will randomly assign patients of a multi-site clinic in Connecticut     to receive one or both of a succession of two commitment contracts. First, a two-month reward     contract will pay participants for (a) engaging in clinic and web-based activities that     support smoking cessation and (b) quitting smoking, as measured at period end. Second, a     four-month deposit contract will invite participants to commit funds which they forfeit     unless they abstain from smoking over the entire period. A random subset of participants will     also have the option to pre-commit to the deposit contract at study enrollment. Reward payout     and deposit recovery will be conditional on biochemical verification of self-reported     abstinence. Investigators will conduct follow-up biochemical verification at 12 months to     observe whether abstinence persists after removal of incentives. The primary outcome of     interest will be continuous abstinence from smoking between months 2 and 12, i.e.     biochemically verified abstinence at all three measurements. A short baseline and endline     survey will also be administered to measure characteristics and outcomes related to smoking     behavior.   "
52676|NCT02596048|"     This is a Phase IV multicenter, open-label study and is being implemented in order to assess     diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography     (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with     IOMERON.   "
52677|NCT02596035|"     This study will generate safety data on Nivolumab given by itself in treatment of advanced     Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related     side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with     Nivolumab.   "
52678|NCT02596022|"     Repeated drug consumption may progress to problematic use by triggering neuroplastic     adaptations that attenuate sensitivity to natural rewards while increasing reactivity to     craving and drug cues. Converging evidence suggests that glutamate modulation may work to     correct these adaptations and rapidly restore motivation for delayed non-drug rewards     relative to immediate drug use. Using an established laboratory model aimed at evaluating     behavioral shifts in the salience of cocaine now vs. money later, the investigators will test     the effect of CI-581a on cocaine self-administration as compared to the active control.   "
52679|NCT02596009|"     The purpose of this study is to compare dynamic inspiratory flow rates achieved by a     population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®,     Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo will be     administered to patients in this study.   "
54643|NCT02570386|"     The objective of the present randomized controlled study is to compare clinical effectiveness     and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared     to fresh embryo transfer, in women undergoing IVF treatment.   "
52681|NCT02595983|"     The purpose of this study was to evaluate the safety and effectiveness of revusiran     (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis, whose disease has continued to     worsen after liver transplantation. Dosing has been discontinued; patients are being     followed-up for safety.   "
52682|NCT02595970|"     Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported     Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety,     tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus     extension) in patients with moderate to severe psoriasis.   "
52697|NCT02595775|"     This project aims to measure the impact of a physician report card (also called an audit &     feedback report) on colonoscopy performance. Endoscopists in Ontario will be randomly     assigned to either receive the endoscopist report card or to no feedback. Using Ontario     health administrative data, the quality of colonoscopy will be compared between those who     received the report card and those who do not. The investigators will also measure the effect     of receiving endoscopist report card on colonoscopy performance amongst endoscopists who     perform poorly at baseline compared to those who do not. Further, the acceptability of two     educational interventions that aim to improve the quality of colonoscopy will be evaluated by     conducting one-on-one interviews with select participants. This study is critical to ensure     that Canadians have access to the highest quality colonoscopy possible.   "
52683|NCT02595957|"     Background:      Genes are the instructions a person s body uses to function. Genome sequencing is a new way     to look at genes that your main research team is using to learn the causes of the condition     they are studying. When a new cause is found this way, it is called a primary variant. Each     person has many variants. Most do not cause disease. Sequencing can also find secondary     variants. These are not related to the condition your main research team is studying, but may     show a person to be at high risk for cancer or another condition. Researchers want to learn     more about what it means to have a secondary variant.      Objectives:      To find new gene changes that lead to certain medical conditions. To better understand the     causes of certain diseases. To learn about how people understand their genetic test results.      Eligibility:      People with rare diseases who have already consented to and enrolled in another protocol run     by a group other than the National Human Genome Research Institute.      Design:      DNA samples that were already collected will be studied.      Participants may be asked to send in a second DNA sample (blood or saliva). These will be     used to verify any findings.      If a primary variant for the participant s health condition is found through genome     sequencing, this will be shared with the participant by their primary research team.      If the participant has a secondary finding, it will be shared by phone call or     videoconference by this research group in the National Human Genome Research Institute. Some     participants may get their results in person at the clinic.      Three months after getting their secondary findings, participants will do an online survey     and phone interview. They will be asked about how they have used the information.      Some people who do not receive a secondary finding from genome sequencing will be asked to do     an online survey three months after the get that result.      Participants who have a secondary finding can get genetic counseling.   "
52685|NCT02595931|"     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970 and     irinotecan hydrochloride in treating patients with solid tumors that have spread to other     places in the body and usually cannot be cured or controlled with treatment (advanced) or     cannot be removed by surgery. ATR kinase inhibitor VX-970 and irinotecan hydrochloride may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
52688|NCT02595892|"     This randomized phase II trial studies how well Ataxia-telangiectasia and Rad3-related [ATR]     kinase inhibitor VX-970 (VX-970) and gemcitabine hydrochloride work compared to standard     treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary     peritoneal, or fallopian tube cancer that has come back after a period of improvement     (recurrent). ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking an     enzyme needed for cell growth, and may also help gemcitabine hydrochloride work better.     Gemcitabine hydrochloride is a drug used in chemotherapy that works to stop the growth of     tumor cells by blocking cells from growing and repairing themselves, causing them to die. It     is not yet known whether adding ATR kinase inhibitor VX-970 to standard treatment with     gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating     patients with ovarian, primary peritoneal, or fallopian tube cancer.   "
52689|NCT02595879|"     This phase I trial studies the side effects and best dose of triapine when given with     radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vulvar     cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell     growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their     deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses     high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard     treatment with cisplatin and radiation therapy may kill more cancer cells.   "
52690|NCT02595866|"     This phase I trial studies the side effects of pembrolizumab in treating patients with human     immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not     respond to treatment (refractory), or have distributed over a large area in the body     (disseminated). Monoclonal antibodies, such as pembrolizumab, may block tumor or cancer     growth in different ways by targeting certain cells. It may also help the immune system kill     cancer cells.   "
52691|NCT02595853|"     Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study     is to determine effectiveness of Hemospray™ on short and medium term in different clinical     situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of     the application of hemostatic powder in routine clinical practice studying in a large sample     of patients.   "
52692|NCT02595840|"     The aim of Trans-MARBLE is to identify and validate novel biomarkers of response and     resistance to maintenance therapy with afatinib or pemetrexed in patients with EGFRmutated     non-small-cell lung cancer who have progressed after first-line therapy with afatinib.   "
52693|NCT02595827|"     Providers in integrated Community Case Management (iCCM) programs in low resource settings     often see children without any danger signs, presenting with fever but not having pneumonia,     malaria, or diarrhea. These children are sent home (often with analgesic only), and     caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if     conditional return advice (i.e. return in 2 or 3 day only if your child is still sick)     results in the same proportion of children remaining with fever one week after     identification, as the current universal return advice.   "
52694|NCT02595814|"     The clinical characteristics, initial presentation, management, and outcomes of patients     hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic     HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF     disease registry designed to characterize patient trajectories longitudinally during and     following an index hospitalization for acute HF.   "
52695|NCT02595801|"     The central hypothesis is that surgery and anesthesia exposure in children with immature     structural and functional brain development has long-term adverse effects on child     development at school-entry compared with children not exposed to anesthesia.      The secondary hypothesis is that frequency of surgery and anesthesia exposure in children     with immature structural and functional brain development has a dose-dependent association     with worsened child development outcomes at school-entry.      The overall objective is to investigate the association between surgery/anesthesia     exposure(s) in children in Ontario and major child development outcomes (physical health and     well being, social competence, emotional maturity, and language and cognitive development) at     school entry as measured by the Early Development Instrument.   "
52696|NCT02595788|"     Transoesophageal ultrasound examination before and after prone position.   "
52698|NCT02595762|"     This disease registry is a prospective, multicenter non-interventional study designed to     observe anti-cancer treatment regimens and clinical outcomes in participants with     HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer     (MBC).   "
52721|NCT02595463|"     The purpose of this study is to determine whether giving lidocaine intravenously during and     after a tonsillectomy surgery is effective in decreasing postoperative pain.   "
52722|NCT02595450|"     This is a non-interventional, open label, single arm, multicenter study to assess the safety     and efficacy of erlotinib in participants with non-small cell lung cancer.   "
52699|NCT02595749|"     Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural     processes that encode, interpret, and respond to socially and emotionally relevant stimuli)     have been implicated in tobacco smoking and relapse, however this potential target for     medication development has not been systematically examined. Evidence from animal and human     laboratories indicate that administration of intranasal oxytocin enhances socioemotional     processing and may be efficacious for the treatment of drug addiction, including nicotine     dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking     cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates     smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular     smokers following overnight abstinence.   "
52700|NCT02595736|"     The purpose of this study is to look at the safety and tolerability of single doses of     LY3200327 when given to healthy male and female participants either by injection under the     skin or by drip into a vein. The study will help determine how the drug behaves inside the     body and how long it takes to disappear from the body. The study will also look for anti-drug     antibodies and how these may affect how LY3200327 acts in your body.      The study is expected to last approximately 12 weeks (with screening evaluations up to 4     weeks prior).   "
52701|NCT02595723|"     This study is designed to test if megestrol acetate induces changes in declarative memory in     healthy controls and if pre-administration of phenytoin can ameliorate any induced cognitive     impairments.   "
52702|NCT02595710|"     Approximately 20 volunteers who have received a liver transplant and have been diagnosed with     cryptogenic cirrhosis will be included in this study. Blood, skin and urine samples will be     analyzed for Bartonella spp..   "
52703|NCT02595697|"     The goal of this study is to conduct an efficacy trial to determine whether an early     communication intervention which blends two evidence-based interventions, Enhanced Milieu     Teaching (EMT) and Joint Attention, Symbolic Play and Regulation Intervention (JASPER),     improves social communication in toddlers with Autism Spectrum Disorder (ASD).   "
52704|NCT02595684|"     Obesity is a chronic disease of multifactorial etiology that develops from the interaction of     the influence of nutritive , metabolic , cellular and molecular psychological factors.      Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for     inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile     dysfunction, and recently approved for the treatment of pulmonary hypertension , it is     innovative because of its longer life means, provides efficacy after 36 hours and the highest     selectivity.      The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and     insulin secretion in obese men.      The investigators hypothesis is that the administration of tadalafil improve the insulin     sensitivity and insulin secretion in obese men.   "
52705|NCT02595671|"     The purpose of this study is to carry out a field trial to evaluate the effectiveness and     added value of the b-SLIM digital Super Coach in a convenient sample of overweight and obese     adults.   "
52715|NCT02595541|"     Pulmonary hypertension (PH) is a consequence of an increase in pulmonary vascular resistance     (PVR), pulmonary blood flow, pulmonary venous pressure, or a combination of these elements.     Pulmonary arterial hypertension is a frequent complication of congenital heart disease,     particularly in patients with systemic-to-pulmonary shunts. Persistent exposure o f the     pulmonary vasculature to increased blood flow and pressure may result in vascular remodeling     and dysfunction. This leads to increased pulmonary vascular resistance and, ultimately, to     reversal of the shunt and development of Eisenmenger's syndrome. It may be more appropriate     to define pulmonary hypertension according to the ratio of MPAP to mean systemic arterial     pressure (MPAP/MAP) because children may have a low mean systemic blood pressure. MPAP/MAP     ratio of < 0.25 is normal, a ratio of 0.33-0.5 indicates moderate pulmonary hypertension, and     a ratio of > 0.5 is indicative of severe pulmonary hypertension   "
52716|NCT02595528|"     This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed     in combination once a day for the improvement of uncorrected near visual acuity in     participants with presbyopia (inability to focus on items close-up).   "
52706|NCT02595658|"     People with Type 1 diabetes (T1DM) are usually provided guidance on how best to control     glycaemia around meal times through adjusting their rapid-acting insulin dose according to     the carbohydrate content of the meal (e.g. 1 IU per 10/15 g of carbohydrate; Schmidt et al.,     2014). However, a potential issue around this method is the role of dietary fat in the     calculation of insulin requirements (Wolpert et al., 2013). The fat component of the meal has     the potential to influence the insulin dose requirement to normalise postprandial glycaemia     (Wolpert et al., 2013). Although normalising postprandial glycaemia is vital, postprandial     lipaemia is also an important consideration for long-term health, and at present there is     scant data in this area in T1DM. In addition, changing the macronutrient composition of foods     and altering insulin doses may carry important implications for vascular function and     prospective appetite regulation.      This research will examine the glycaemic and lipaemic responses after consuming a mixed meal     similar in carbohydrate content, but differing in fat content. Moreover, this research will     assess whether acute postprandial reductions in insulin sensitivity can be offset through     increasing the dose of rapid-acting insulin for such meals. Venous blood samples will be     collected before and for 6 hours after meals, for the determination of glycaemic and lipaemic     responses, as well as metabolite and hormonal parameters. In addition this study will assess     the impact of mixed meals and adjusting insulin dose on vascular function and subjective     ratings of appetite.      The findings from this study will benefit patients with type 1 diabetes by the provision of     more refined self-management strategies for insulin dosage around meal-times.   "
52719|NCT02595489|"     In this pilot study, the investigators will assess the safety of two high-dose regimens of     oral vitamin D supplementation and measure the effects of vitamin D supplementation on     markers of oxidative stress and inflammation in the blood and brain of study participants     before, during, and after taking vitamin D supplements.      The goal of the study is to establish research measures (i.e. biomarkers) and an optimal dose     for vitamin D supplementation in boys with the X-linked adrenoleukodystrophy (ALD) genotype.   "
52723|NCT02595437|"     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered     intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis     (CKD-5HD). It is an open-label, two-period sequential dosing study.   "
52707|NCT02595645|"     Colorectal cancer ist the 2nd most leading cancer among men and women in germany. Screening     colonoscopy has the potential to detect premalignant lesions. By endoscopical resection of     these lesions, colorectal cancers could be avoided. The decision for surveillance is made     according to patients medical history, amount and histological characteristics of the     resected polyps. Molecular guided decisions are still missing. Thus, further tools and     mechanisms, beyond but in addition to endoscopy and histopathological, are strongly required     to reduce such interval carcinomas and get a better and deeper inside into molecular     alterations which occurs in premalignant lesions in the colon and describe risk populations     which might benefit from shorter surveillance strategies by colonoscopy. Therefore GENESIS     will enroll 100 patients, which underwent screening colonoscopy with polyp ectomy. All     biopsies were stored and processed without formalin in special boxes (PaxGene by Qiagen®).     After microdissection of polyp tissue and isolation of DNA targeted next generation     sequencing of 38 cancer-related genes followed by bioinformatics and systems biology     analyses. The sequencing results were correlated to the endoscopical and histopathological     findings. In parallel we are collecting EDTA-blood samples for analysis of circulating     cell-free DNA (cfDNA) to investigate the potential of liquid biopsies in premalignant     colorectal lesions.   "
52708|NCT02595632|"     The purpose of this study is to detect a specific profile of breath in healthy subjects by an     untargeted metabolomic study using exhaled breath analysis by mass spectrometry.   "
52709|NCT02595619|"     This study aims to assess whether in patients with acute kidney injury (AKI) requiring     mechanical ventilation, a strategy that combines renal replacement therapy (RRT) and     extracorporeal carbon dioxide removal (ECCO2R) allows reduction of tidal volume and plateau     pressure. Systemic Inflammatory Response and Safety Variables will also be analysed.   "
52710|NCT02595606|"     A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium     Hyaluronate in the treatment of Dry Eye of diabetic patients.   "
52711|NCT02595593|"     This is a multicenter randomized study investigating the differences in clinical outcomes of     patients between two standard of care pathways for rib trauma: patients who receive rib     fixation versus patients who receive modern critical care and pain control after sustaining     clinically significant rib fractures from trauma.   "
52712|NCT02595580|"     Diabetes mellitus type 1 (DM1) is an autoimmune metabolic disease in which the insulin     producing cells in the pancreas are destroyed and the subject is left totally dependent of     external supply of insulin. There is no known cure for DM1 except for in very specific     situations. Thus, management of DM1 concentrates on keeping blood glucose levels as close to     normal levels.      As an aid to subjects with DM1 for managing their blood glucose levels as close to normal as     possible, blood glucose monitoring systems have been developed. Available blood glucose     monitoring systems today require a capillary blood sample that is analysed by a glucose     meter. Subjects are normally advised by health care professionals on the appropriate blood     glucose monitoring regime for their condition. However, many subjects fail to measure blood     glucose as often as needed to achieve good blood glucose control despite every effort from     health care professionals.      Research and development of non-invasive interstitial blood glucose monitoring methods is     ongoing. All attempts to develop a non-invasive continuous glucose measuring device have so     far failed. Prediktor Medical AS has developed a non-invasive sensor, GlucoPred, based on the     combination of several non-invasive measurement principles and multivariate analysis and     dynamic models of glucose/insulin interaction. The device will be body mounted in the form of     a bracelet or a watch communicating with a mobile phone or a tablet for data presentation and     collection. Development of GlucoPred is now at a stage where testing of the sensor in     subjects under controlled settings is required before further development can take place.      If successful, this will be a major step ahead for all patients with diabetes and markedly     increase their possibility to take care of their disease on a day to day basis without the     burden of frequent blood sampling or wearing an invasive device.   "
52713|NCT02595567|"     The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural     catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to     conventional medical therapy. Hepatic Hydrothorax (HH) is defined as an accumulation of fluid     in the pleural space between the chest wall and the lung and occurs in 5-10% of patients with     liver disease. Despite medical therapy with diuretics and salt restriction, many patients     still experience intractable, debilitating shortness of breath, often necessitating hospital     admission. Repeated thoracentesis,which is a procedure in which the hepatic hydrothorax is     drained with a needle may be effective, but is often only temporary prior to the     reaccumulation of fluid leading to the requirement of repeated procedures. Trans-jugular     intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always     effective or able to be performed. Similarly, liver transplantation although potentially     curative, is not available to many patients and may be significantly delayed. Many patients     do not experience sufficient or timely relief with current conventional therapy.   "
52714|NCT02595554|"     Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome     to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a     hypothesis in terms of survival and treatment related morbidity.   "
64349|NCT02443376|"     Central blood pressure and pulse wave velocity were measured using a Complior Analyse device     before and immediately after the end of the dialysis session.   "
52717|NCT02595515|"     Infantile colic is condition that affects more than 10% of babies and their families. The     reason, and hence proper treatment, for this condition is unknown and many causes have been     suggested. One of the treatments that parents choose is chiropractic manipulation. In     Denmark, almost 10,000 babies are each year treated by chiropractors, and a high proportion     is due to colic. However, the effect of chiropractic treatment of infantile colic has not     been properly scientifically evaluated.      The effects of chiropractic treatment on infantile colic needs to be investigated, since this     is a very common disorder with no known effective treatment, but with good empirical evidence     of the value of chiropractic treatment. Although it is usually considered to be a benign and     self-limiting condition, some studies suggest there might be long-term effects in terms of     psychomotor problems. In worst case, the infants' crying may also lead to violence and     'shaken baby syndrome'.      Null hypothesis: There is no effect of chiropractic treatment on the course of infantile     colic.      This study is a controlled, clinical trial where infants fulfilling the diagnostic criteria     for colic will be randomized into two groups. One group will receive treatment and the other     won't. This will determine the overall effect and furthermore, subgroup analyses will be     performed to identify possible subgroups of infants, who will benefit the most from the     treatment.   "
52718|NCT02595502|"     The purpose of this investigation is to evaluate the short-term, clinical performance of two     silicone hydrogel daily disposable contact lenses.   "
52724|NCT02595411|"     The aim of the study is to investigate the reliability of the Melbourne Assessment.   "
52726|NCT02595385|"     The aim of this study is to compare retrograde autologous priming (RAP) of the bypass circuit     to cell salvage (CS) as part of blood conservation strategies in adult cardiac surgery. It     hypothesizes that RAP is at least as effective as cell salvage in terms of blood conservation     but at the same time more cost effective.   "
52727|NCT02595372|"     In preliminary laboratory science studies, the investigators show that proton pump inhibitors     (PPIs) effectively inhibit human fatty acid synthase (FASN) and breast cancer cell survival.     A preliminary retrospective study shows that PPI usage in breast cancer patients during     chemotherapy significantly improved overall survival. The impact was most striking in     patients with triple negative breast cancer (TNBC). Thus, PPIs may be repositioned as safe     and effective breast cancer drugs to enhance the effect of chemotherapy.      Many of the hurdles that slow progress from target, to lead compound, to investigational     agent, to standard therapy are not barriers for the PPIs. The PPIs are FDA-approved,     chronically used, and well tolerated so the investigators can move quickly from the     laboratory to a proof of concept clinical trial. Incorporating the PPIs into standard care     will require more than the investigators propose here, but the investigators have already     plotted the additional steps needed to truly impact patient care. If successful, the data     gathered in this proposal will lend support to and guide development of a definitive     randomized trial.   "
52728|NCT02595359|"     The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of     intracameral moxifloxacin for prevention of postcataract endophthalmitis.   "
52729|NCT02595346|"     This study evaluates the benefits of hydroxychloroquine on arterial function in     antiphospholipid syndrome.      Briefly, the patients will be randomized in two groups, one will receive hydroxychloroquine     and standard treatment, the other will receive placebo in addition of standard treatment.   "
52730|NCT02595333|"     This study aims to compare the pain degree between primary cesarean section and repeated     cesarean section, and investigate the role of flurbiprofen axetil in postoperative analgesia,     so as to provide reference for clinical practice.   "
52731|NCT02595320|"     The purpose of this study is compare different doses of capecitabine to see if one is better     than the other in terms of efficacy and toxicity.   "
52732|NCT02595307|"     To determine if providing a written document in addition to the standard oral discussion of     surgical risks improves risk recall for the parents/guardians of a child seen in consultation     for cleft palate surgery, and if this has any effect on overall satisfaction after the     procedure   "
52733|NCT02595294|"     The purpose of these study is to compare the effectivity of the Cervical Lateral Glide     physical therapy neural mobilization technique to the complete absence of treatment in a     group of patients who suffer cervicobrachial pain.   "
52734|NCT02595281|"     HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of     serum HE4 before surgery has been demonstrated to predict overall survival and its interest     has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk     patients. To date, no study shows clearly the predictive potential of serum HE4 as an early     relapse biomarker in ovarian cancers.   "
52736|NCT02595255|"     While most of the children spontaneously recover menstruation or experienced normal puberty     after chemotherapy, their ovarian reserve may be impaired by treatment inducing future     infertility. Fertility preservation is currently proposed for selected prepubertal patients     with a high risk of premature ovarian failure after treatment (mostly conditioning regimen     for bone marrow transplantation). For patients with low or moderate risks, counselling is     very difficult and no fertility preservation procedure is usually proposed for these patients     as no marker of the ovarian reserve has been validated in this young population to assess the     individual risk.      The primary objective of the study is to prevent long-term treatment-related infertility by     detecting the young patients who normally progressed to menarche but have a reduced ovarian     reserve. These patients may benefit from particular follow-up and fertility preservation     procedure.   "
52737|NCT02595242|"     The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome     Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the     treatment of Diffuse Large B Cell Lymphoma.   "
52738|NCT02595229|"     Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar     plate fixation of distal radius fractures with regard to the forearm pronation strength.     During the early recovery period of 3 months an improvement of pronation strength and     functional scorings was hypothesized for the PQ repair when compared to no repair.      Randomization of the patients in two groups ( PQ repair and no repair) and follow-up     examinations after 6 and 12 weeks included bilateral isometric pronation strength     measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue     scale (VAS)   "
52739|NCT02595216|"     Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult     volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a     single treatment to the submental area with the profound device; subjects will return to four     follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.      Prior to treatment, tissue will be treated with injected tumescence or local dermal     infiltration solution according to the protocol.   "
52740|NCT02595203|"     The primary objectives of this study are:        -  To determine the mass balance recovery (expired air, urine and faeces) and route and          rate of elimination of 14C-Debio 1450.        -  To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and          faeces.        -  To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and          Debio 1452 (active moiety) in plasma and urine.   "
52741|NCT02595190|"     There are very few data and analysis in the literature regarding the symptomatic sacral     perineurial cysts. Most studies are case reports or small retrospective sample, which rarely     more than 20 cases. There is no an consensus on the choice of treatment (medicine     conservative treatment and surgical treatment) for symptomatic sacral perineurial cysts.Our     aim, therefore, is to compare the efficacy of medicine conservative treatment and surgical     treatment for symptomatic sacral perineurial cysts by a randomized controlled trial.     Meanwhile, resting-state functional magnetic resonance imaging is used to detect the changes     at pain related brain areas, which will be develop an objective method to evaluate the     clinical curative effect of the two treatment options.   "
52743|NCT02595164|"     The role of impulsivity and its contribution to suicidal behavior seems intuitively clear.     Empirical results have proved the existence of a relationship between the two yet many     questions are left unanswered, especially what differentiates suicide ideators from     attempters.. Obsessive thinking patterns are thought processes which share a repetitive     behavior domain and are exerted by an inner voice. 3 types of obsessive thinking patterns are     self destructive thoughts, ruminations and overvalued ideas. Impulsivity and obsessive     thinking patterns are presumed to have a common mechanism of behaviors which are resulted     from basal ganglia dysregulation and thus effect inhibition. Novel research in the field of     decision making could help to learn more about behavioral patterns associated with self harm     behavior and suicide. Eating Disorders involve suicidal and self harm behavior, which both     feature impulsivity and obsessive thinking patterns. The investigators study proposes a     3-step theoretical model which asserts there is a connection between impulsivity, obsessive     thinking and poor decision making, all effecting self harm behavior. Contemporary research     has not been able to fully understand the nature of impulsivity and its effect on self harm     behavior, including eating disorders symptoms, nor addressed the impact of obsessive thinking     patterns on the latter. 100 female participants with Eating Disorders and suicidal behavior     will be recruited for the proposed research. Subjects will be given self-report     questionnaires and computerized behavioral tasks. A one way ANOVA of two eating disorder     subgroups, impulsive and non impulsive, will be conducted, following a hierarchical multiple     regression with self harm behavior being the dependent variable.   "
52744|NCT02595151|"     The morphologic change of microvessels has the clinical value to distinguish cancerous from     non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory     hemodynamic changes real-time using pCLE, compare the differences between chronic nonatrophic     gastritis and GIM; then evaluate the possible mechanisms associated with gastric mucosal     blood flow in GIM.   "
52745|NCT02595138|"     Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and     limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options.     Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the     number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant     therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who     were receiving aromatase inhibitors. So it might be able to improve the survival of triple     negative breast cancer patients.   "
52760|NCT02594943|"     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this     study is as follows:        -  Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to          establish the correct diagnosis of diffuse gastric cancer based on collected biopsies          from tumor tissue.   "
52761|NCT02594930|"     The purpose of this study is to determine whether an undirected synovial biopsy technique has     the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic     assisted directed synovial biopsy technique.   "
52746|NCT02595125|"     Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years     depending on the model) and among the most effective. However, there are many obstacles to     the use of IUDs including pain felt by patients during installation. Several medical means     were studied without evidence of their efficacy in pain related to IUD insertion. In order to     remove this brake, it's important to find another way to act against this pain. The direct     technique is one of the techniques described by health professionals. It seems trusted by its     users as a more reliable technique but also less painful for patients. However, there is no     study available on its evaluation. The aim of this study is to investigate the interest of     the direct technique in reducing the pain experienced by patients during installation.   "
52747|NCT02595112|"     Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium.     Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This     study is aimed at evaluating the relationship between Staphylococcus aureus strains     colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.   "
52748|NCT02595099|"     The purpose of this project is to investigate the feasibility and acceptability of a     Mindfulness based intervention for people who are attending secondary care with     Osteoarthritis (OA)-related knee pain.   "
52749|NCT02595086|"     The aim of this study is to show better postoperative quality of life including lower     incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving     gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with     middle-third early gastric cancer   "
52750|NCT02595073|"     Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to     Severe Atopic Dermatitis   "
52751|NCT02595060|"     This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients     with pneumonia associated acute respiratory distress syndrome (ARDS). A third of the patients     will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will     receive inhaled placebo for 3 days. The patients will be followed for 28 days.   "
52752|NCT02595047|"     The purpose of this study is to observe the feasibility and its application of autologous     prefabrication for body surface tissues/oranges   "
52753|NCT02595034|"     This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl     Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel   "
52754|NCT02595021|"     The purpose of this study is to evaluate the safety and one year disease-free survival of     total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial     ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).   "
52755|NCT02595008|"     this study is to evaluate the potential of DSXS to suppress HPA axis function in patients     with moderate to severe atopic dermatitis.   "
52777|NCT02594722|"     Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral     muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of     daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation     (NMES) are currently being adapted and tested to support exercise training.      The investigators hypothesized that functional electrical stimulation cycling improves VO2     and aerobic capacities during exercise compared to endurance training.   "
52756|NCT02594995|"     Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of     deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood     flow to part of the brain from an acute arterial occlusion. Survival of penumbral tissue     distal to an arterial occlusion depends on collateral circulation via the Circle of Willis     and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated with     infarct growth. The presence of adequate collaterals has been shown to be associated with     age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated from     the seeds of celery, and found to exert protective effects against ischemic brain and     increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed     during acute stroke will have a significant effect to improve collateral circulation in     patients of anterior circulation occlusion.   "
52757|NCT02594982|"     Abstract Background Studies have shown that delirium in medical and surgical intensive care     units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia     symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium in     the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two     instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment     Method for the ICU (CAM-ICU).      Aims        1. To measure the effect of a systematic intervention (sedation, sleep, mobilization and          pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU.        2. To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method          The design of the study is a two-phase interventional trial. Based on a power          calculation, 56 patients will be enrolled both in the baseline and the intervention          group (n=112).      Part 1: A baseline investigation will be conducted to establish prevalence, duration and type     of delirium symptoms in patients with acute acquired brain injury before implementing the     intervention bundle.      Part 2: A systematic Intervention protocol will be implemented in the N-ICU. The Intervention     elements consist of a sedation, sleep, mobilization and pain treatment regimen based on the     newest available evidence.      Enrolled patients will be contacted 12 months after discharge for a follow-up including a     quality of life with (EuroQoL-5D) questionnaire, a cognitive test measuring their cognitive     end point (Repeatable Battery for Assessment of the Neuropsychological Status) and a short     test for dementia symptoms (MMSE, Mini Mental State Examination).   "
52758|NCT02594969|"     The goal is this study is to investigate the effects of dilute bleach on the skin of subjects     with atopic dermatitis and those with healthy skin. The second goal is to evaluate the     effects of different moisturizers on the skin barrier of subjects with and without atopic     dermatitis. The investigators hypothesize that the bleach bath will increase the skin pH,     decrease the skin hydration, and increase skin water loss in all study subjects. Secondly,     the investigators hypothesize that moisturizers with the lowest pH and the highest water to     oil ratio will result in improved skin barrier function. Furthermore, the investigators     believe there will be a greater improvement in patients with atopic dermatitis.   "
52759|NCT02594956|"     The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current     practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity,     delayed gastric emptying and finally an increased length of hospital stay.      The absence of NG decompression could be the corner stone of the concept of the enhanced     recovery program after PD.   "
54880|NCT02567292|"     This study aims to identify whether an all breast milk (BM) diet would improve outcomes in     neonates with congenital gastrointestinal disorders (CGD) by facilitating an earlier     transition off of parenteral nutrition (PN).   "
52762|NCT02594917|"     The investigators are performing this research study to determine whether having low     iron-sulfur cluster levels can cause a disease known as pulmonary hypertension (PH). PH is     defined as abnormally high blood pressure in the arteries of the lungs.      Usually, small specialized structures inside each human cell called mitochondria are in     charge of generating energy within lung arteries for normal function. During situations of     disease or stress, lung arteries undergo a change in teh function of mitochondria, resulting     in the development of PH. In studies on mice, investigators have learned that alterations in     the production of specific metal complexes called iron-sulfur clusters are responsible for     these changes. This makes it more likely that mice will develop PH.      In this study, the investigators want to find out if alteration of iron-sulfur cluster     formation leads to increased likelihood of developing PH in humans.   "
52763|NCT02594904|"     Neonatal Glucose-6-phosphate Dehydrogenase(G6PD) Deficiency is one of the significant reason     for neonatal hyperbilirubinemia and even irreversible bilirubin encephalopathy.The neonates     may be attacked due to acute infection, eating beans or exposure to oxidative drugs, etc.      The main clinical manifestations are hemolytic anemia, and the resulting hyperbilirubinemia.     When bilirubin is pretty high in body, bilirubin may spread into brain, and thus cause     nervous system damage, and severely affect the prognosis of neonates. Therefore, monitoring     and early intervention of jaundice has important significance to prevent further aggravation     of jaundice and certain sequelae. Phototherapy and exchange transfusion are mainly suitable     methods for severe hyperbilirubinemia, however, patients need to be hospitalized. Yinzhihuang     Oral Liquid is a kind of traditional Chinese medicine for jaundice. Many large sample and     multicenter clinical studies show that the positive efficacy of Yinzhihuang Oral Liquid in     the treatment of neonatal hyperbilirubinemia is exactly confirmed.      The purpose of this study is try to detect the treatment effect of Yinzhihuang Oral Liquid on     indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.     Try to provide scientific theories for Yinzhihuang Oral Liquid to treat neonates with G-6-PD     enzyme deficiency and neonatal hyperbilirubinemia.   "
52764|NCT02594891|"     Cholangitis is one of the main complications of endoscopic retrograde     cholangiopancreatography (ERCP). Plastic biliary stent was used to prevent the occurrence of     post-ERCP cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope     again. 8.5 F plastic stent with proximal flap can discharge self-driven from biliary to the     gut, it has the advantage of avoiding pulling stent out with endoscope again. The purpose of     this study is to explore 8.5 F plastic stent with proximal flap on preventing post-ERCP     cholangitis of ERCP in patients with choledocholithiasis.   "
52840|NCT02593903|"     The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following     distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract     infection and complications.   "
52765|NCT02594878|"     In a randomized double blind placebo controlled trial to investigate the effect of     pamidronate in treatment of chronic non bacterial osteomyelitis.      Main objective:        1. Reduction of the inflammatory activity in the bone lesions measured by whole body MRI          after 36 weeks.        2. Healing of the inflammatory activity in the bone lesions measured by whole body MRI          after 36 weeks.      Secondary objectives:        1. Changes in bone lesions in whole body MRI between baseline and week 12 and between week          12 and week 36        2. Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between          baseline and week 36.        3. Changes in patient self reported outcome measures        4. Changes in inflammatory markers and bone markers.   "
52766|NCT02594865|"     To investigate whether the administration of Glucerna achieves less glycaemic variability,     defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a     standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be     used to evaluate glycaemic variability and glycaemic control.   "
52767|NCT02594852|"     In this study the investigators want to investigate if the pregnancy rate in conjunction with     fertility treatment increases with concomitant use of laser therapy.   "
52768|NCT02594839|"     The study evaluates the safety and the efficacy of the addition of intravenous     transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic     interstitial pneumonia or connective tissue disease associated with interstitial lung     disease, which have actively progressing disease with rapid loss of pulmonary function on the     background of routine treatment.   "
52769|NCT02594826|"     This is a randomized trial to evaluate the effects of a community-based intervention on     increasing cervical cancer screening rates in underserved Korean American women. Due to the     multiple factors that contribute to screening uptake, an educational program customized to     Korean culture combined with navigation assistance may be effective in increasing the number     of Korean American women who can access cervical cancer screening.   "
52770|NCT02594813|"     The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy or cold     snare polypectomy) in patients who continue to take various antithrombotic drugs is studied     prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other     endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic     clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed     bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after     endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy.     Additionally, investigators evaluate the rate of injured submucosal arteries of the excised     specimen when the bleeding occurs.   "
52771|NCT02594800|"     Atherosclerotic intracranial arterial stenosis (AICAS) corresponds to luminal narrowing of     the major intracranial arteries. The prevalence of intracranial atherosclerotic stenosis     accounts for 33% to 67% of stroke or transient ischemic attack (TIA) cases in China and other     countries in Asia. AICAS is also highly associated with the risk of stroke recurrence.     Possible mechanisms of cerebral infarction secondary to AICAS are likely linked with     hemodynamic compromise distal to site of stenosis.      Computed tomography perfusion (CTP) can be used to evaluate vasoreactivity and     cerebrovascular reserve in patients with AICAS and predict future stroke. The parameters of     CTP include ①cerebral blood flow(CBF),② cerebral blood volume(CBV) and ③mean transit     time(MTT). Relative regional cerebral blood flow (rCBF) was evaluated as the percentage     radioisotope counts in the region of interest (ROI) of the affected side against the     corresponding ROI in the unaffected contralateral side.      Statins can decrease the incidence of transient ischemic attack or ischemic stroke and     improve stroke outcome. Few studies focus on the relationship between statins therapy and     cerebral perfusion.      Whether intensive rosuvastatin therapy compared with standard rosuvastatin therapy can     improve hemodynamic situation and cerebral perfusion status in AICAS has not been     illustrated.      Based on those studies, the investigators hypothesized that intensive rosuvastatin may also     improve the symptoms of AICAS not only through enhancing the stability of atherosclerotic     plaques, but also its pleiotropic effects. So it can change the hemodynamic status around the     plaque and increase cerebral flow in the downstream territory. So in this study the     investigators try to analysis statin's impact on the hemodynamic changes as well as the     downstream perfusion which is determined by CTP.   "
52773|NCT02594774|"     The objective is to evaluate the efficacy of osteopathic treatment as an adjunct to standard     medical treatment in reducing child functional abdominal pain.      A convenience sample that includes no more than 30 patients per study group (n = 60) are     being recruited. As an exploratory study the investigators did not proceed to make any sample     size calculation.      This is a comparative study of two quasi-experimental interventions (standard treatment vs.     standard treatment + Osteopathy).      This will be a single-blind trial where only the evaluator will be blinded. The principal     outcome will be pain measured by a visual analog scale. A version with more appropriate     pictograms for pediatric patients is used. Measurements will be taken at baseline (baseline     measurements) at 4, 8 weeks (the duration of interventions) and 6 months post-study.   "
52774|NCT02594761|"     The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan     trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and     pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8     mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male     subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square     mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three     similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules     vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®.     Secondary objectives included further pharmacokinetic assessment of similarity of Hercules,     EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of     safety (including immunogenicity) and local tolerance.   "
52775|NCT02594748|"     The aims of the study are as follows:        -  To improve self-management intention and behavior of patients with type 2 diabetes (T2          DM).        -  To promote patients to make plans for their self-management and gradually integrate the          self-management plan into their daily life.        -  To improve resilience, well-being, fatigue and quality of life of patients with T2 DM      In order to achieve the aims, we have set the following objectives:        -  To develop and apply self-management education program based on the extended theory of          planned behavior.        -  To evaluate the efficacy of the educational program:             1. Self-management education program delivered face to face (intervention group); (b)               standard usual care (comparison group).   "
52776|NCT02594735|"     The purpose of this study is to assess the safety and efficacy of subcutaneous abatacept in     10 patients eight years of age and older with refractory JDM.   "
70183|NCT02367157|"     The purpose of this study is to determine how the applications of Kinesio Tape affect the     morning stiffness in patients with rheumatoid arthritis.   "
52778|NCT02594709|"     Traditional treatment options for optic nerve sheath meningiomas (ONSM) include observation,     surgery and radiotherapy, but to date none of these has become the clear treatment of choice.      The role of the radiotherapy remained uncertain because of the concern about radiation     related optic neuropathy In the recent past two large series of patients treated with a     fractionated stereotactic radiotherapy confirmed these positive experiences in tumour control     and greatly reduced the concern about the treatment related toxicity.      Under the light of successful meningiomas treatment, radiosurgery, had proposed as a     treatment option. Single session, high conformality, frame based radiosurgery systems are     seldom if ever proposed as ONSMs treatment due to the known dose tolerance of the optic     nerve.      The first experience in ONSMs treatment with multisession radiosurgery treatment was quite     promising.      The aim of the present study is to prospectively evaluate the efficacy and safety of     multisession radiosurgery in ONSMs treatment.      In order to evaluate multisession radiosurgery 50 patients will be enrolled in the present     study.      All patients will be treated by using multisession radiosurgery, with 5 fractions of 5 Gy     each to a total dose of 25 Gy prescribed to the 75-85% isodose line. Patients were evaluated     both for tumor growth control and visual function.   "
52779|NCT02594696|"     Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder are     dying younger than the general population; cancer is a leading cause of death in this     population. People with SMI have higher rates of dying from breast, lung, and colon cancer,     and disparities in treatment appear to be one contributing factor. Individuals with SMI may     be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate     cancer treatment. Although collaborative care models integrating medical and psychiatric care     have shown promise in other populations, the challenge of treating SMI and cancer is distinct     and relatively understudied. Patients may have uncontrolled psychiatric symptoms that can     impact their understanding of their diagnosis and treatment decisions. Oncologists have less     training and inadequate time to address multiple unmet needs. Mental health care is     frequently fragmented from cancer care.      The investigators want to understand if it is helpful for patients with SMI to be connected     to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms     and facilitating communication between the patient, the oncology team, and mental health     providers may improve care. The goal is to pilot a pragmatic intervention for patients with     cancer and SMI that can be integrated into cancer care, is acceptable to patients and     oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to an     underserved population.      Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will     follow the patient and communicate with the oncology team during the 12 week intervention.     All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology     clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment     received and healthcare utilization will be assessed at 6 months post-intervention.   "
52780|NCT02594683|"     A follow-up study of a randomised, controlled, study to investigate the effects of a new     infant formula given in the first 12 months of life on growth and body composition up to 5     years of age   "
52781|NCT02594670|"     Selecting different acupoints as an combination of acupoints is a key factor to clinical     efficacy of acupuncture. Different combinations of acupoints will generate different clinical     efficacy. So,the purpose of this study is to determine the different clinical efficacy among     three types of combinations of acupoints in the treatment of primary insomnia.   "
52831|NCT02594020|"     This study concerns the prevention of dental caries by sealing pits and fissures of permanent     molars with a photopolymerizable resin. It must compare these three techniques Microdentisty     (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities     in the enamel and / or the outer third of the dentin. These three commonly used techniques     have never been compared by retaining as endpoint retention of sealant. These techniques are     painless and do not require local anesthesia.   "
52782|NCT02594657|"     Nowadays, ECC exercise can be realized using various modalities that target small or large     muscle masses in a segmentary or dynamic way. The training program proposed in this study is     realised on an handmade ergocycle which allows eccentric contractions.      With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an     exercise realised at the same power output with a concentric ergocycle. Due to this later     propertie, which origins are not yet fully identified, there is an increasing interest to     embed ECC in rehabilitation programs.      The investigators hypothesis that a higher pedal rate will induce a lower oxygen consumption,     with the same benefits.      This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per     minute (rpm).      The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and     to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption     observed.   "
52783|NCT02594644|"     The aim of this study is to investigate how varying incubation periods of topical     aminolevulinic acid after pretreatment with microneedle application can facilitate the     penetration and efficacy of photodynamic therapy.   "
52784|NCT02594631|"     The aim of the study is to compare the safety and efficacy of ESWL and visual     cystolitholapaxy in management of calcular acute urine retention.   "
52785|NCT02594618|"     The aim of this study is to assess energy regulation of overfeeding and performing common     household activities in young Chinese males using whole-body room calorimetry up to 10 hours.   "
52786|NCT02594605|"     Platelet rich fibrin is a second generation platelet concentration which contains various     growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of     PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.   "
52787|NCT02594592|"     This cross-sectional study aimed to validate the effectiveness of the combined use of the     Osteoporosis Self-Assessment Tool for Asians (OSTA) and the One-Minute Osteoporosis Risk Test     (IOF test) in a population from Wuhan, China.   "
52788|NCT02594579|"     A randomized double blind placebo control trial study will be conducted in critically ill     patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3     supplementation, compare to placebo, on skeletal muscle mass and body composition.   "
52810|NCT02594293|"     This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in     96 weeks after nucleoside analogue (NUC) withdrawal.      The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and     reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment     guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC     treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN     alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC     treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.   "
54823|NCT02568033|"     This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy     to treat stage II and III lung cancer that is not amendable to surgical resection.   "
52789|NCT02594566|"     If the participant decides to take part in the study, the participant will need to do the     following:      Visit the study clinic up to 10 times and be available for a reasonable amount of follow up     phone calls to see how the participant is doing.      The participant will receive three doses of vaccine injected into the muscle of the upper     arm. After each injection the participant will be asked to remain at the study site for at     least 30 minutes after the participant receives the study vaccine.      The results of all of the participants blood tests, just like all other laboratory test     results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV     and viral hepatitis test results will be reportable to local health authorities according to     local laws.      The participant will be asked to refrain from excessive physical activities and alcohol     consumption within 2 days before each clinic visit to avoid possible confusing effects on     laboratory tests.   "
52790|NCT02594553|"     The CHILI cluster randomised controlled trial (RCT) will investigate whether the use of an     interactive information booklet during consultations for febrile children at General Practice     (GP) out-of-hours centres can reduce the number of antibiotic prescriptions, improve parental     satisfaction and reduce intention to reconsult for childhood fever episodes.   "
52791|NCT02594540|"     The purpose of this study is to evaluate safety and effectiveness of the peripheral     mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF     levels, immunological profile and brain functional connectivity changes in patients with     Parkinson's disease.   "
52792|NCT02594527|"     Physical activity levels of hospitalised older inpatients is low and this results in many     adverse health outcomes. Studies have shown that interventions designed to promote increased     physical activity of older inpatients using paid staff have shown improvement in physical     function of older inpatients, resulting in shorter hospital stay and reduced admissions to     nursing home. This study aims to assess the feasibility and acceptability of using trained     volunteers to increase physical activity of older people in hospital. Volunteers will be     recruited and trained to encourage older inpatients to mobilise or perform chair-based     exercises. Patients will be encouraged to walk or exercise with the volunteers twice a day     during their hospital stay. Quantitative analysis will be conducted on the outcome measures.     Patients, volunteers and staff members will also be interviewed to assess the acceptability     of the intervention. This feasibility study will help inform a future controlled trial.   "
52793|NCT02594514|"     Severe obesity (SO), defined as BMI≥95th percentile, has increased worldwide among     adolescents. American studies estimated that 1.3-2.8% of 12-19-year-old individuals have a     BMI >40 kg/m2 or a BMI >35 kg/m2 with at least one serious co-morbidity. The immediate and     long-term risks associated with SO in adolescents include cardiovascular and metabolic     diseases, obstructive sleep apnoea and nonalcoholic fatty liver disease. However, the results     of sleeve gastrectomy in adolescents are still uncertain.      Objective and hypotheses: Investigators aimed to assess the long-term safety, efficacy, and     cardiovascular risk changes of laparoscopic sleeve gastrectomy in adolescents with SO.      Method: Longitudinal retrospective study of 22 adolescents with SO who underwent laparoscopic     sleeve gastrectomy. Clinical and metabolic variables immediately before surgery and after 6,     12, 18 and 24 months were assessed.   "
52794|NCT02594501|"     The purpose of this study is to determine whether patients undergoing coronary intervention     that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual     anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic     events than compared with standard FDA-approved drug eluting stent (DES) plus 6-month DAPT.   "
52795|NCT02594488|"     The majority of deaths after myocardial infarction occurs in patients with preserved left     ventricular ejection fraction (>35%) for whom no prophylactic strategies exist. Periodic     Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic risk     markers that identify a new high risk group of patients with LVEF 35-50% who have the same     poor prognosis as patients with LVEF ≤35%.      In SMART-MI, post-infarction patients with LVEF 35-50% and abnormal PRD and/or DC will be     randomly assigned to biomonitoring-guided therapy or conventional follow-up.   "
52796|NCT02594475|"     Endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in diagnosis and     treatment of pancreaticobiliary diseases. Traditionally, ERCP has been performed in the prone     position. The prone position for ERCP can facilitate selective bile duct cannulation, offer a     better fluoroscopic image of pancreaticobiliary anatomy, and prevent aspiration of gastric     contents. However, in cases of difficult in the prone position, ERCP has been performed in     the left lateral or supine position. Compared with the prone position, left lateral position     is more comfortable for patients, especially with limitation for cervical movement including     cervical cord injury, cervical spine operation, parkinson's disease, contracture due to     cerebral infarction, and allow more easy passage of the scope through the pharynx, and useful     to secure airway. However, in the left lateral position, it is difficult to obtain     fluoroscopic image of right hepatic duct and intrahepatic bile duct.      In cases of severe abdominal pain, severe abdominal distension, large amount of ascites,     recent abdominal surgery or cervical spine surgery, intra-abdominal catheter insertion,     severe obesity, it is difficult to position in prone or left lateral, therefore, ERCP may be     performed in the supine position. In supine position for ERCP, there has been documented     increased risk of cardiopulmonary adverse event and decreased success rate of selective bile     duct cannulation.      There have been reported the efficacy and safety between the prone position and supine     position for ERCP in several studies. We aimed to evaluate the efficacy and safety between     the prone position and left lateral position for ERCP in this prospective, randomized study.   "
52811|NCT02594280|"     Establish electrophysiological benchmarks, using the Diopsys Visual Evoked Potential/ Pattern     ERG (VEP/PERG) protocols of populations with Glaucoma following: 1) Baseline VEP/ERG prior to     treatment; and 2) VEP/PERG after treatment.   "
52812|NCT02594267|"     The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in     combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in     patients with newly diagnosed peripheral T-cell lymphoma (PTCL).   "
52813|NCT02594254|"     The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of     time either with a toothbrush or a custom dental tray can effectively kill bacteria in the     mouth that cause dental cavities.   "
52797|NCT02594462|"     Sickle cell anemia is a homozygous genetic disease with high prevalence in Brazil. There are     changes in conformation and physicochemical properties of red cells that generate varied     clinical manifestations among which is chronic hemolytic anemia, cardiovascular diseases,     fever, splenic sequestration and usually painful crises. Women with sickle cell anemia have     high maternal-fetal and neonatal morbidity and mortality. During pregnancy, there is     intensification of maternal anemia, episodes of painful crises; and also, more obstetric     risks, such as pre-eclampsia, thromboembolism and hemorrhage. Thus, there is the need for     adequate reproductive family planning for this population conducted mainly through hormonal     contraception. The World Health Organization recommends that all contraceptive methods may be     prescribed for people with sickle cell anemia women, being the progestogen-only contraceptive     methods the most indicated due to no changes in venous or arterial thrombosis. Nevertheless,     there is need for further scientific evidence as the best contraceptive choice among women     with sickle cell anemia in relation to safety, adhesion and reduction of pain crises. The     objective of this study is to evaluate the clinical effect through safety of     etonogestrel-releasing contraceptive implant in women with sickle cell anemia during twelve     months.   "
52798|NCT02594449|"     To compare pharmacodynamics among the different concentrations of BCS and NS.   "
52799|NCT02594436|"     This is a prospective, non-interventional study of adult patients prescribed topical     treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment     of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete     clearance at 8 weeks will be followed for one year or until retreatment of AK in the area     initially treated, whatever comes first. For patients with incomplete clearance in the     treated area at 8 weeks the treatment strategy for this area will be recorded but no further     follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction     and health-related quality of life (HRQoL) associated with Picato® treatment will be     evaluated.   "
52800|NCT02594423|"     The cornea is the transparent window of the eye, which allows light to enter into the eye and     also contributes to the focusing of the light rays. One of the major factors responsible for     its transparency is the lack of blood vessels. However, following inflammation new blood     vessels (corneal vascularisation [CVas]) grow into the cornea affecting its transparency and     impairing vision. CVas leads to further damage in the form of scarring,oedema,fat deposition     and is a major cause of corneal graft rejection.      In 2000 with ethical approval (OY129801) the investigators developed and published a clinical     technique called Fine Needle Diathermy occlusion of corneal vessels (FND). This has proven     very successful for occluding established vessels and is practiced in many centers across the     world. Recently it has been demonstrated that by inhibiting a chemical stimulant of vessel     formation called vascular endothelial growth factor(VEGF) active new vessel growth in the     retina can be suppressed. The approach is also being used for corneal new vessels.     Bevacizumab (Avastin) is a chemical inhibitor of VEGF and is used extensively to treat     retinal new vessels in macular degeneration. Avastin has been shown to be effective and safe     in treating corneal new vessels. The investigators propose to evaluate the efficacy and     safety of FND alone and FND combined with Avastin in treatment of CVas.   "
52801|NCT02594410|"     To evaluate the efficacy of renal artery stent combined with standardized medical therapy as     treatment for renal artery stenosis.   "
52802|NCT02594397|"     The purpose of this study is to determine whether the different combination of acupoints have     different effect on diabetic gastroparalysis.   "
52803|NCT02594384|"     This is a Phase 1 dose exploration study of LAM-002A administered by mouth in patients with     relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK) and     preliminary activity will be evaluated.   "
52804|NCT02594371|"     To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic     breast cancer   "
52805|NCT02594358|"     Prospective data on the visual acuity response in children treated by patching concurrently     treated with caffeine and estimate the magnitude of effect that might be seen in a randomized     trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not     to conduct a randomized, double blind trial).      Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant     treatment for amblyopia and provide limited data on its safety.      Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability     of patching on the child and family.      Demonstrate recruitment potential of subjects to participate in a dietary intervention study.   "
52806|NCT02594345|"     This study is designed to analyze the effect exosomes derived from red blood cell units have     on blood coagulation and platelet function. It is an in vitro study using healthy volunteers'     blood.   "
52807|NCT02594332|"     The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on     airway physiology in patients with eosinophilic asthma   "
52808|NCT02594319|"     This research seeks to examine psychological factors that may impact relationship between     incentives and health behavior engagement, specifically fruit and vegetable consumption.     Additionally, it will compare the impact of two different incentive schedules on behavior     engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and     another providing delayed rewards (i.e. rewards received at the end of the study period),     with a control condition in which no rewards are offered. Study participants will provide     reports of their fruit and vegetable consumption each day for three weeks, and in the two     incentive conditions, they will receive small monetary rewards for their fruit and vegetable     consumption. Following the three week reporting and reward period, participants will complete     two additional assessments, measuring psychological constructs and behavior engagement     following the cessation of rewards.   "
52809|NCT02594306|"     Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by     non-medical usage, long and repeated exposure to addictive drugs and gradually increasing     drug-taking dosage and frequency,and become a main threat against human being's public     health, economic development and social safety.   "
52814|NCT02594241|"     Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be     randomized to either methylprednisolone or saline preoperatively, to examine the effects of     methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia     repair.   "
52815|NCT02594228|"     A primary aim of the current proposal is to compare the effect of daily consumption of     healthy lean protein as either whey protein (2 meals per day) or whole food (25% of total     daily caloric intake) consumed as 6 small meals throughout the day, one of which is consumed     immediately following exercise training (within 30 min) and another 2 hours prior to going to     bed at night, over a 16 week period on muscle and fat mass, cardiovascular health, aerobic     fitness, glucose, insulin, blood lipids, heart rate and muscle strength in overweight men and     women.   "
52816|NCT02594215|"     Background:      Proteus syndrome (PS) is caused by a mutation in the AKT1 gene. This gene makes a protein     that communicates with other proteins in the body to make cells grow. The AKT1 mutation     changes chemical signals in the body and causes overgrowth. PS can be fatal. The drug ARQ 092     reduces signals from the AKT1 protein. This may reduce or stabilize some of the overgrowth in     people with PS. Researchers want to find the best dose of ARQ 092 based on its effect on     tissues in people with PS.      Objective:      To determine the safety, tolerability, and recommended dose of ARQ 092 in people with PS.      Eligibility:      People ages 6 and older with PS      Design:      Participants will be screened with medical history, physical exam, and blood and urine tests.      Participants will take ARQ 092 by mouth once daily for up to 12 28-day cycles.      Participants must stay near the NIH Clinical Center (CC) during the whole first cycle, for     weekly visits to the CC. For cycle 2, they will have visits every 2 weeks. They will have 1     visit before cycles 3 and 4, and once before every other cycle for cycles 5 11. The final     visit will be at the end of cycle 12. Visits may include:      Small skin samples taken.      ECG: Soft electrodes on the skin record heart signals.      Echocardiogram: A small probe held to the chest takes pictures of the heart.      MRI: Participants will lie in a machine that takes pictures of the body.      Joint and mobility function tests.      Participants will complete surveys by phone and in person.      Participants will keep a daily medication and symptom diary.   "
52817|NCT02594202|"     Background:      Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want     to study blood, tissue, and fluid samples of people with prostate cancer. This will help them     understand any changes in cells and genes. These changes might lead to the development and     progression of prostate cancer. Researchers think the study could lead to new treatments.      Objective:      To understand the changes in cells and genes that lead to the development and progression of     prostate cancer. This could lead to new treatments.      Eligibility:      Men ages 18 and older who have or are suspected to have prostate cancer      Design:      Participants will be screened with physical exam and medical history.      Participants will send tissue blocks of their tumor, if possible. If not, they will provide     unstained slides of tumor tissue.      Participants may provide samples of blood, urine, saliva, and prostate secretions.      Participants may have imaging tests. They will lie in a machine that takes pictures of their     body. These tests include:      MRI of the prostate      CT of the abdomen and pelvis      Chest x-ray      Participants may need a biopsy or surgery for treatment of their cancer. If so, researchers     will collect tissue.      Participants may answer questions about their prostate cancer and quality of life.      Participants may have follow-up visits or other treatments. They may have follow-up phone     calls every few months.   "
52887|NCT02593292|"     This French multicentre open-label randomized trial will test the hypothesis that a     coordinated health circuit based on obstetric risks, backed up by an electronic patient care     reporting information system will optimize the continuum of pregnancy care monitoring. The     electronic patient care reporting information system will be shared between patients, private     practice physicians/midwifes, hospital physicians/midwifes and supervised by a coordinating     midwife.   "
52818|NCT02594189|"     Background:      Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also     be more serious. Researchers want to know more about how influenza causes disease in people.     They hope to develop new vaccines and treatments for flu infection.      Objective:      To find the smallest amount of Influenza A H3N2 virus that causes a mild to moderate flu     infection in healthy people. Also, to study the body s immune response to this virus and how     the infection develops.      Eligibility:      Healthy people ages 18 50 who are:      Non-smokers or non-habitual smokers      Willing to not smoke for at least 9 days      Design:      Participants will be screened under NIAID protocol #11-I-0183      Participants will stay at an isolation unit at the clinic for at least 9 days. They will     remain in the isolation unit except for study-specific activities.      The influenza virus will be sprayed into the nose.      Participants will be monitored 24 hours a day. They will have tests, including:      Medical history      Physical exam      Daily questionnaires about symptoms      Blood and urine tests      Nasal wash and swab: A small tube of salt water is placed in the nose to wash it. It then     collects the      fluid. Or the inside of the nose is rubbed with a swab.      ECG: Measures the heart s electrical signals      ECHO: Sound waves take pictures of the heart      PFTs/Spirometry: They will blow into a machine that measures the air they blow.      Participants will be discharged after they test negative for influenza A.      Participants will return to the clinic for 4 follow-up visits over 8 weeks. They may complete     questionnaires at home.   "
52819|NCT02594176|"     Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain     related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical     intolerance to NSAIDs.      Secondary Objectives        -  To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and          improvement of joint function in patients contraindicated for or with clinical          intolerance to NSAIDs and with OA of the knee.        -  To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated          for or with clinical intolerance to NSAIDs and with OA of the knee.   "
52820|NCT02594163|"     This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate     the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine     for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell     lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in     patients ineligible for autologous stem cell transplant (ASCT).   "
52821|NCT02594150|"     A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical     Test is increased by the addition of financial incentives.   "
55742|NCT02556021|"     The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once     daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4   "
52822|NCT02594137|"     The purpose of this study is to compare two surgical techniques for a neurosurgical procedure     used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs.     without watertight duraplasty (rapid closure decompressive craniectomy).   "
52823|NCT02594124|"     The primary objective is to evaluate the long-term safety and tolerability of nusinersen     (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular     Atrophy (SMA) who previously participated in investigational studies of nusinersen. The     secondary objective is to examine the long-term efficacy of nusinersen administered by IT     injection to participants with SMA who previously participated in investigational studies of     nusinersen.   "
52824|NCT02594111|"     Inflammation in the arteries of the heart may increase the risk of cardiac death. The     proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory     medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of     the heart. With its quick onset of action and excellent safety profile, colchicine may have     the potential to reduce risk of major adverse events related to the heart. This research also     seeks to better understand the role of neutrophils, the most common type of inflammatory     white blood cell in the body, when there is damage to the heart.   "
52825|NCT02594098|"     Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can     affect males and females of all ages, but often starts in childhood. Recent studies show at     least 4-7% of adults and 15-25% of children to be affected, with one third of patients having     severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens     the symptoms and causes the skin to become thickened over time. Patients with atopic     dermatitis have an increased risk of skin infections, and many also develop hay fever or     asthma. Atopic dermatitis can cause significant distress to both patients and their families.      In this study, the aim is to assess the effects of a new treatment called secukinumab in     patients with atopic dermatitis. A total of 30 patients will be included in the study, which     will run for a total of 52 weeks.   "
52826|NCT02594085|"     The objective is to investigate the impact that faecal output has on adhesives.   "
52827|NCT02594072|"     Two radiation therapy techniques are commonly used for the treatment of intermediate and high     risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT). However, both     have limitations. Brachytherapy, in which radioactive seeds are inserted into the prostate,     produces excellent outcomes but is invasive and not all patients are eligible or willing to     receive this treatment. EBRT, while gentle at the time of delivery, tends to be very     prolonged and may have poorer outcomes than brachytherapy. This study will examine the use of     stereotactic ablative radiotherapy (SABR), in which patients are given only a few, high dose     radiation treatments. Treatments are short, non-invasive, applicable to patients not able to     do brachytherapy, and may be more effective than conventional EBRT. This study will compare     SABR with EBRT in terms of the rates of acute and late toxicities for each treatment,     disease-free survival, and health-related quality of life measures.   "
52828|NCT02594059|"     The aim of the study is to assess the peripheral endothelial function in adult patients with     idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial     function and the severity of the IPF.   "
52829|NCT02594046|"     This randomized, placebo-controlled, double-blind study evaluates the efficacy and     tolerability of the allogeneic human adipose derived stem cell component extract on     androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of     allogeneic human adipose derived stem cell component extract per month or a placebo for 16     weeks.   "
52830|NCT02594033|"     This trial is conducted in Europe. The aim of the trial is to investigate different needle     features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the     trial drug in the body)   "
52832|NCT02594007|"     Heart Failure (HF) affects 5.7 million Americans and is the only major cardiovascular     disorder on the rise. The primary aim of this study is to formally study the combined effects     of several different tele-health modalities, all currently approved and available for general     use, to determine if such combinations will result in an increase in early intervention and a     resultant decrease in acute cardiac decompensation requiring a hospitalization or Emergency     Room (ER) visit. This study will attempt to characterize the frequency of health care     interventions attributable to the use of these technologies, and any relationship between     these interventions and the frequency of hospitalization or ER visits.      Secondary objectives include characterization of healthcare utilization, healthcare costs,     and patient experiences with regard to the use the provided technologies.   "
52834|NCT02593981|"     As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall     asleep and 19% complain of early-morning awakening. The implications of this sleep     deprivation are sobering, particularly among older individuals.      The primary goal of this study is to determine whether a palatable foodstuff which contains a     fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in     community-living individuals with sleep problems.   "
52835|NCT02593968|"     The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population     with HPV-16 and/or HPV-18.   "
52836|NCT02593955|"     The purpose of this randomized, controlled interventional study is to determine the effects     of a high intensity exercise training program on objective sleep measures, daytime     sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's     disease.   "
52837|NCT02593942|"     Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for     this purpose. The hemodynamic stability and at the same time early emergency are the main     goals following neurosurgery. However there is no standard for discontinuation time for     manually controlled systems today.      The investigators aimed to study the effect of remifentanil infusion alone for early     emergence and hemodynamic stability during the closure period in patients undergoing     supratentorial craniotomy.   "
52838|NCT02593929|"     This study will identify baseline and/or pharmacodynamic biomarkers of response to     ruxolitinib, based upon association with quantitative change in tumor size following 14-21     days of neoadjuvant ruxolitinib in patients with operable HNSCC.   "
52839|NCT02593916|"     To create a registry/database of patients who either have taken drugs that treat     cardiovascular conditions or that have presented with cardiovascular symptoms that may be     related to medication.   "
52841|NCT02593890|"     A randomised interventional comparative control study will be undertaken to compare the THEYA     Recovery Range postoperatively for patients undergoing wider lumpectomies, partial     mastectomies and total mastectomies to current practice using a mixed method combining     quantitative and qualitative instruments. 100 female participants are hoped to be recruited     following breast surgery after a newly diagnosed breast cancer.      This study will answer the research question:- What is the clinical and psychosocial impact     of the THEYA Recovery Range in comparison to recommended practice during and after breast     cancer treatment? This study will leverage the findings of a pilot study conducted by     Applied Research Connected Healthcare (ARCH) measuring the usability of the THEYA Recovery     Range.      This study aims to assess the participants' experience of recovery in the immediate     post-operative period and the psychosocial effect of THEYA Recovery Range in comparison to     current recommended practice.   "
52842|NCT02593877|"     This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided     transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma     patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst     the other half will receive massive transfusion protocol resuscitation using conventional     coagulation tests.   "
52843|NCT02593864|"     Veterans have much higher risk of osteoarthritis (OA) then the general population. Knee OA is     common among Veterans and is a leading cause of disability. The earliest stages of OA     development, where the joint cartilage wears away, is usually painless. By the time Veterans     experience symptoms, the OA is typically advanced and there is nothing that can be done     except palliation until the joint is replaced with metal and plastic. If there was a blood     test to provide early warning of cartilage wear and joint deterioration, Veterans could     potentially be treated early enough to slow down or even prevent OA. So far, development of     such a blood test has proved elusive. The investigators propose a new method to amplify the     signs of cartilage wear in the blood by challenging the affected joint with a walking task.     Similar to a cardiac stress test, this walking challenge may help to separate joints at risk     from healthy joints. The investigators will also see if this 'OA stress test' can show if a     simple and inexpensive load-modifying shoe can improve joint health in Veterans with early     knee OA.   "
52844|NCT02593851|"     The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral     activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection     after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in     infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are     hospitalized with RSV infection.   "
52845|NCT02593838|"     This study aims at evaluating the feasibility of CT myocardial perfusion imaging in daily     clinical practice and compare it to SPECT perfusion imaging in order to assess sensitivity     and specifity of CT myocardial perfusion imaging compared to SPECT.   "
52888|NCT02593279|"     The aim of the study is to describe asthma phenotype with small airways dysfunction, in a     multiparametric manner, with clinical, biological, morphological and genetic elements     compared with asthma with proximal airways obstruction.      The objective of this study is also to complete the clinical, immunobiological and     morphological analysis of asthma with small airways dysfunction.   "
62165|NCT02471898|"     A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Evaluation of the Efficacy     and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy   "
52846|NCT02593825|"     The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To     Play (START-Play), an intervention designed to target sitting, reaching, and motor-based     problem solving to improve development and readiness to learn in infants with motor delays or     dysfunction. There is limited research examining the efficacy of early physical intervention     on infants with neuromotor dysfunction. In addition, most early motor interventions have not     been directly linked to learning, despite the research demonstrating an association between     motor activity and cognitive skills. START-Play specifically targets motor skills that lead     to greater physical exploration, which has been associated with improved problem solving and     global development. A randomized controlled trial of START-Play will be conducted across four     states to investigate the impact of the intervention on changes over time in sitting and     reaching, subsequent changes in global cognitive development, and the mediating influences of     motor skill changes and problem solving. The research team will conduct a randomized     controlled trial to evaluate the impact of START-Play on motor development, motor problem     solving, global development including cognitive problem solving of infants with neuromotor     delay and dysfunction. Infants will experience either the intervention or services as usual     for 3 months, with following testing at three time points up until 9 months post     intervention. The researchers will determine whether the intervention leads to improved     sitting and reaching, which leads to improved motor-based problem solving, which leads to     improved global development and problem solving.   "
52847|NCT02593812|"     The study determines whether standard medical care (dopamine) affects learning and retention     of a postural stepping task in people with Parkinson's disease (PD) and whether training on a     postural stepping task generalises to performance on an untrained postural task. Half the     participants will train on the stepping task after they have taken their first dose of     dopamine for the day (i.e. on medication state) while the other half will train on the same     stepping task before taking their first daily dose of dopamine (i.e. off medication state).   "
52848|NCT02593799|"     Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In     the early stage of liver cirrhosis, the prediction of esophageal varices is very important     for guiding the clinical decision making of primary prophylaxis of variceal bleeding.   "
52849|NCT02593786|"     The purpose of this study is to determine whether nivolumab is safe and effective in the     treatment of advanced or recurrent solid tumors in Chinese subjects.   "
52850|NCT02593773|"     The purpose of this phase 3 multi-center, open-label extension study is to evaluate the     long-term safety of ACTIMMUNE® (interferon-γ 1b) in subjects with Friedreich's Ataxia (FA).   "
52862|NCT02593617|"     The objective of this study is to investigate the prevalence of energy drink, alcohol and     substance use among university students; to explore whether there is a relationship between     energy drink consumption and alcohol-substance use in university students or not and to     evaluate effect of impulsiveness and sensation seeking on this relationship.   "
52851|NCT02593760|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy and safety of vismodegib plus (+) ruxolitinib versus placebo + ruxolitinib in     participants with intermediate- or high-risk MF. The study will be divided into 2 components.     The Phase Ib portion of the study consists of participants receiving open-label vismodegib     (150 milligrams [mg] orally [PO] once daily [QD]) + ruxolitinib (PO twice daily [BID]). A     safety assessment will be performed after the first 10 participants have been treated for 6     weeks. An analysis for efficacy and safety is planned in the first 10 participants at Week     24. There will be a hold on participant screening and enrollment during this assessment.     Another 10 participants may be enrolled, thereafter, to further assess efficacy and safety     (at Week 24) before the initiation of the Phase III randomization portion of the study.     Similarly, there will be another hold on participant screening and enrollment during this     assessment. The participants enrolled in the Phase Ib portion of the study will continue to     receive vismodegib (150 mg PO QD) + ruxolitinib (PO BID) for up to 48 weeks, if clinical     benefit is observed after 24 weeks. The Phase III randomized, double-blind portion of the     study will enroll approximately 84 participants. Participants will be randomly assigned in a     1:1 ratio (double blind) to receive either vismodegib (150 mg PO QD) + ruxolitinib (PO BID)     or placebo (PO QD) + ruxolitinib (PO BID) for up to 48 weeks.   "
52852|NCT02593747|"     To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus     Claritin Peach Syrup 1mg/mL (ANNA Formula)   "
52853|NCT02593734|"     The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and     daily contact with a nurse for people with mental health disorders in a prayer camp and     secondly to assess whether the attitudes of the prayer camp staff toward mental health     disorders and conventional medicines remain the same after the intervention.   "
52854|NCT02593721|"     The purpose of this study is to compare the effectivity of Median Nerve Neural Mobilization     and oral Ibuprofen in treating patients who suffer cervicobrachial pain   "
52855|NCT02593708|"     Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the     safety and tolerability of the combination of neratinib plus paclitaxel, trastuzumab and     pertuzumab to determine the recommended Phase II/III dose of this combination.      Neratinib will be given once daily days 1-21 and should be taken orally with food. Paclitaxel     and trastuzumab will be given IV on days 1, 8, and 15 out of 21 day cycles. Pertuzumab will     be given IV every 3 weeks on day 1 out of 21-day cycles. Each cycle will be 21 days in     duration.      Patients will continue on treatment until disease progression or intolerable toxicity.   "
52856|NCT02593695|"     Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates     under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe     Anorexia nervosa.   "
52857|NCT02593682|"     The purpose of this study is to provide some information (pilot data) about whether the study     drug, suvorexant, (1) affects levels of orexin in people with panic disorder, and (2) is     associated with decreased panic symptoms in response to a carbon dioxide (CO2) challenge.   "
52858|NCT02593669|"     A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in     vision. It is the most prevalent, treatable cause of visual impairment and blindness in the     world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and     thought to be the most effective surgical procedure in any field of medicine. In this trial,     the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and     sleep as well as the effect of the blue light transmission characteristics of the implanted     IOL on sleep.   "
55885|NCT02554136|"     The investigators investigate the potential pharmacokinetic drug-drug interaction between     HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and     both together in a 3 period repeatedly   "
52859|NCT02593656|"     This study systematically quantified the effects of the Isagenix Performance System (IEPS)     compared to a standard recommended control (C) diet both of which were combined with a     4-day/week exercise training program on total and regional (abdominal) body composition (lean     mass and fat mass), muscular strength and performance, flexibility, blood lipids and glucose,     hormones, mood state and energy metabolism in 60 healthy middle-aged (25-55 years old) men     and women following a 12-week intervention. Participants were enrolled in one of two cohorts:        1. Isagenix Energy & Performance System, 2g/kg/Body Weight (BW) Protein (IEPS) (n=30)             1. IEPS-I, n=15; consume protein feeding immediately after exercise             2. IEPS-2, n=15; consume protein feeding 2 hours after exercise        2. Control, 1g/kg/Body Weight Protein (C) (n=30)   "
52860|NCT02593643|"     Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality     from psychiatric illnesses. In 2009, the World Health Organization listed depression as the     leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause     of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada,     2012) and the 2nd most common cause of death in young people after accidental deaths. This     information highlights the importance of finding treatments to prevent suicidal deaths.      Ketamine has been shown to provide rapid treatment response for major depressive episodes     both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous     infusion which persists for at least 72 hours.      The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual     (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT     examining these treatments for decreasing suicidal ideation among depressed inpatients with     major depressive disorder and bipolar depression.      A total of 52 patients will be recruited for this trial. All subjects will be inpatients at     Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or     bipolar disorder type I or II currently depressed. Suicidal ideation must be present at     baseline assessment in order to be included in the study. Thirteen subjects will be     randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to     ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the     midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar depression     will be randomized to these two treatments.   "
52861|NCT02593630|"     This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged     12 to 15 years.   "
70184|NCT02367131|"     Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese     elderly patients with type 2 diabetes mellitus.   "
52863|NCT02593604|"     Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked     by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI,     Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).   "
52864|NCT02593591|"     The next generation of personalized medical treatment according to the type of personal     genetic information are evolving rapidly. The genome analysis needs systematic infra and     database based on personal genetic information. Therefore, a big data of genome-clinical     information is important.      To determine the feasibility of the use of tumor's molecular profiling and targeted therapies     in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS,     duration of response and overall survival )of patients with advanced cancer, the     investigators are going to take a tumor tissue of patients and process molecular profiling     and receive molecular profile directed treatments.   "
52865|NCT02593578|"     The next generation of personalized medical treatment according to the type of personal     genetic information are evolving rapidly. The genome analysis needs systematic infra and     database based on personal genetic information. Therefore, a big data of genome-clinical     information is important.      To determine the feasibility of the use of tumor's molecular profiling and targeted therapies     in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS,     duration of response and overall survival )of patients with advanced cancer, the     investigators are going to take a tumor tissue of patients and process molecular profiling     and receive molecular profile directed treatments.   "
52866|NCT02593565|"     The purpose of this study is to learn about the experience of women with vasculitis who     become pregnant. In particular, the study will consist of several online surveys to assess        1. each woman's vasculitis severity and pregnancy-related experiences, and        2. pregnancy outcomes.   "
52867|NCT02593552|"     This pilot study was done to assess the feasibility and possible efficacy of a video feedback     intervention to improve the safety of cognitively impaired older drivers.   "
52868|NCT02593539|"     This is a multi-center, non-randomised, open-label, uncontrolled, single group study to     investigate the safety and pharmacokinetics (PK) during 84 days repeat dosing treatment with     1000 micrograms (mcg) of inhaled GSK2269557 in addition to standard of care, in subjects with     activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110delta-activating mutation     causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI). To date     GSK2269557 has been administered to healthy subjects (smokers and non smokers), subjects     with: stable Chronic Obstructive Pulmonary Disease (COPD); subjects experiencing a COPD     exacerbation; and subjects with persistent, uncontrolled asthma. As this study is the first     administration of GSK2269557 to subjects with APDS, this study will provide safety,     tolerability, efficacy and pharmacokinetic data in this patient population. Up to 20 subjects     will be enrolled into the study. The total duration of the study is approximately 30 weeks,     including pre-screening/screening and follow-up.   "
52869|NCT02593526|"     The proposed pilot study challenges the current widespread paradigm of discontinuing loop     diuretics when initiating chronic HD and/or maintaining the dialysate at a constant     temperature of 37 °C for all patients.   "
52870|NCT02593513|"     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional     study.   "
52950|NCT02592473|"     The purpose of this project is to evaluate the safety, efficacy, and feasibility of     performing prostatic artery embolization (PAE) using endovascular techniques and particle     embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic     hyperplasia (BPH).   "
52871|NCT02593500|"     A SINGLE CENTER, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, TWO PERIOD CROSSOVER STUDY TO DETERMINE     THE BIOEQUIVALENCE OF TWO INHALATION FORMULATIONS CONTAINING BUDESONIDE 200 µg ADMINISTERED     AS 3 PUFFS (TOTAL DOSE OF 600 µg) IN AT LEAST 52 HEALTHY MALES AND FEMALES UNDER FASTING     CONDITIONS      The study objective is to determine whether the inhaled test product, budesonide 200 µg     (pressurized inhalation suspension) and the inhaled reference product, Budesonida Pulmictan®     200 µg (budesonide; pressurized inhalation suspension) are bioequivalent.      For this purpose the PK profile of budesonide will be compared after administration of a     single dose of 600 µg (3 puffs) of each of the two inhalation formulations, under fasting     conditions.   "
52872|NCT02593487|"     In many large trials, reducing low density lipoprotein (LDL) levels with rosuvastatin     decreased the incidence of major cardiovascular events，but little attention to the effects of     rosuvastatin on HDL level，especially on HDL subtype.      Epidemiological evidence strongly favors the notion that the risk of cardiovascular disease     (CVD) is inversely related to the plasma high-density lipoprotein (HDL) cholesterol     concentration.      HDL can be subdivided into large-sized (HDL2a, HDL2b) and small-sized subclasses (preb1-HDL,     HDL3c, HDL3b, HDL3a) and preb2-HDL. Some studies indicate that only large HDL2a and HDL2b     particles make HDLs possess anti-atherogenic functions.      The investigators assume that rosuvastatin could play the role of anti-atherosclerosis though     the levels of HDL2a、HDL2b increased.   "
52873|NCT02593474|"     The purpose of this open-label pilot study is to determine the tolerability and applicability     of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25     (older youth) with opioid use disorder. Outpatient treatment will consist of a 7-day     outpatient detoxification / naltrexone induction procedure followed by 8-weeks of treatment     with Vivitrol.   "
52874|NCT02593461|"     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional     study.   "
52875|NCT02593448|"     The purpose of the present study is to assess, by near infrared spectroscopy with INVOS     oximeter during vascular occlusion test (VOT), the influence of cardiopulmonary bypass on     tissue saturation in thenar muscle.      The secondary aim is to compare the effects of propofol and sevoflurane anaesthesia on tissue     saturation.      It is a prospective, randomized, open-label study. Sixty cardiac surgery patients will     receive either propofol or sevoflurane anaesthesia. Three-minute VOT will be performed at the     following time points: 30 minutes after anaesthesia induction, directly after sternotomy, 20     and 40 minutes after aortic cross-clamping, 20 minutes after aortic cross-clamp removal, and     45 minutes after weaning of cardiopulmonary bypass (CPB).      Group and time effects on tissue saturation will be analysed with ANOVA and post hoc Tukey's     test.   "
70185|NCT02367118|"     The purpose of this study is to determine whether prednisone is effective in the treatment of     chronic rhinosinusitis without nasal polyps in adult patients.   "
52876|NCT02593435|"     Purpose:        1. Screening of large samples is to search the gene mutation of the breast cancer          susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.        2. To build the breast cancer BRCA1/2 mutation database of Chinese group.        3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.   "
52877|NCT02593422|"     This online study aims to understand whether writing about one's experiences with ovarian     cancer may be beneficial for psychological and physical wellbeing in women with a history of     ovarian cancer. Investigators are also interested in studying how certain individual     characteristics may impact the effectiveness of writing. Participants will be asked to     complete an initial survey (15 min), followed by writing about their experiences with ovarian     cancer on four occasions (20 - 25 min each), over the course of two weeks. A final survey (10     min) will be completed one month afterwards.   "
52878|NCT02593409|"     Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving     antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this     possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one     year.   "
52879|NCT02593396|"     The purpose of this study is to assess the tolerability, safety, and efficacy of bupropion     hydrochloride sustained-release in the treatment of sexual dysfunction in men on methadone     maintenance therapy.   "
52880|NCT02593383|"     evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in     treatment of chinese patients with acne.   "
52881|NCT02593370|"     The main objective of the trial is to complete a double-blinded randomized controlled trial     with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift     technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel     Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator     nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.   "
52882|NCT02593357|"     The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic     obstructive pulmonary disease) patients and the relationship between the peripheral     endothelial function and the pulmonary function.   "
52883|NCT02593344|"     The aim of the study is to assess the peripheral endothelial function in adult asthmatic     patients and the relationship between the peripheral endothelial function and the pulmonary     function.   "
52884|NCT02593331|"     This study will evaluate the safety and tolerability profile of BFKB8488A following     subcutaneous (SC) administration in overweight and obese participants (body mass index [BMI]     greater than [>] 27 to less than or equal to [</=] 40 kilograms per square meter [kg/m^2])     with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be     evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of     BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose     cohorts. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will     open to evaluate the PK of BFKB8488A after intravenous (IV) administration.   "
52885|NCT02593318|"     The purpose of this study is to determine if oxaloacetate (OAA) is safe and tolerable at     doses of up to 2 grams per day in people with Alzheimer's disease (AD).   "
52886|NCT02593305|"     The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate     supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity,     and blood pressure responsiveness to a variety of physiological stressors in older healthy     adults. We will also examine the effect of dietary nitrate supplementation on measures of     central artery stiffness and aortic blood pressure in older adults.   "
52889|NCT02593266|"     The overall aim of this pilot study is to evaluate the acceptability and feasibility of an     adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean     families.      The PIP is a family intervention directed towards strengthening family functioning and     enhancing resilience in children of depressed parents. It comprises several modules that work     on psycho-education and skill development within the family nucleus.      A single-blind randomized controlled trial will be conducted with two arms, the intervention     arm (n=32) which will receive a home-based PIP for depression, and the TAU arm (n=32).   "
52890|NCT02593253|"     This single-blinded, cluster randomized control trial will assess the effectiveness of an     audit and feedback bundle on internal medicine physician performance on selected quality     metrics. The feedback bundle includes an electronic dashboard and weekly feedback rounds in     which physicians will review their performance. The control arm will undergo audit and     feedback per the current system, which is biweekly feedback emails with performance.   "
52891|NCT02593240|"     Worksites offer attractive locations for reducing the national prevalence of overweight and     obesity. Interventions that are both effective and sustainable for producing long-term     changes in health and employee wellness are urgently needed. In an 18-month worksite     randomized controlled trial in 12 worksites this study will test two lifestyle approaches     designed to facilitate behavior modification for achieving long-term improvements in health     and quality of life. Worksites randomized to the immediate intervention arm will receive the     two on-site wellness programs and the randomized control sites will participate in outcomes     assessments for the initial 6 month period after which participants will receive vouchers to     participate in the program of their choice. The primary focus of the worksite wellness study     is to identify ways to improve health related quality of life, with a particular focus on a     decrease in cardiometabolic risk factors, including weight, improved weight-related wellness,     and improved energy level in work and life. The combination of 2 interventions will be tested     against the control condition in an intention to treat model and with a completers analysis.   "
52892|NCT02593227|"     This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate     Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without     a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or     adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).   "
52906|NCT02593045|"     The primary objective of this first in human study is to assess the safety and tolerability     of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with     relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a     Maximum Tolerated Dose (MTD).   "
52893|NCT02593214|"     General objective:      To assess the performance and safety profile of a novel innovative design of female condom     (Wondaleaf®) among healthy married women.      Specific objectives :        -  To determine the failure rate of Wondaleaf®, in terms of clinical breakage, non-clinical          breakage, invagination, misdirection, and slippage.        -  To determine the acceptability and satisfaction of use of Wondaleaf® by subjects and          their spouses.        -  To assess the safety profile of Wondaleaf®.   "
52894|NCT02593201|"     Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in     Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent     peritonitis remains the major cause of peritoneal failure. A recent study showed that an     elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of     antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We     hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD     effluent bacterial DNA fragment levels could prevent the development of relapsing and     recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD     peritonitis. After inform consent, they will be randomized to receive one additional week of     the effective antibiotic treatment (the Preemptive Treatment Group) or no additional     treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to the     completion of antibiotics for the measurement of bacterial DNA fragments. All patients will     be followed for 6 months after completion of antibiotic therapy for the development of     relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy     of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent     peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic     treatment.   "
52895|NCT02593188|"     The purpose of the proposed study is to acquire additional data (including the assessment of     anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed     treatment regimens and treatment administration in routine clinical practice.   "
52896|NCT02593175|"     The goal of this clinical research study is to learn if receiving 4 cycles of an experimental     chemotherapy combination before surgery can help to shrink or slow the growth of tumors     before they are removed through surgery. The safety of this combination will also be studied.   "
52897|NCT02593162|"     Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir     and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve     participants with genotype 4 hepatitis C virus (HCV) infection.   "
52898|NCT02593149|"     To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard     HD end caps compared to the Tego® connector with the Curos® for Tego disinfecting port     protector.   "
52899|NCT02593136|"     This study evaluates the program effectiveness of home fortification along with infant and     young child feeding (IYCF) counseling as a strategy to address anemia and complementary     feedings gaps in a program setting of the Integrated Family Health Initiative being     implemented by CARE India (a non-profit organization) in partnership with the Government of     Bihar. The study also seeks to assess the field level worker experience with counseling and     dissemination of home fortification products.   "
53146|NCT02589925|"     Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and basal     nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of     Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having     mild to moderate dementia.   "
52901|NCT02593110|"     The TELEX trial will establish whether telmisartan alone improves walking performance in     people with peripheral artery disease (PAD). The TELEX trial will also determine whether     telmisartan plus supervised exercise improves walking performance more than either therapy     alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 240     participants with PAD randomized to one of four arms: Group A: telmisartan + supervised     exercise therapy; Group B: telmisartan + a no exercise control group; Group C: placebo +     supervised exercise therapy; and Group D: placebo + a no exercise control group.   "
52902|NCT02593097|"     Migraine is the third most prevalent disease in the world. Preventive treatment is indicated     in about 40% of individuals with episodic migraine. Although 4 treatments are approved by the     US Food and Drug Administration for prevention of episodic migraine, none were designed to     prevent migraine, efficacy is modest, and all have significant adverse-event profiles. As a     result, less than 1/3 of migraine sufferers with who are candidates for prevention receive     drug treatment and of those who are treated, more than 85% have discontinued the preventive     drug within one year. Migraine pain is associated with the activation and sensitization of     specific receptors involved in pain-promoting pathways. Metformin, which is a widely     available, well-tolerated anti-diabetic medication, can downregulate pain-promoting pathways.     Metformin has demonstrated positive results in animal models of migraine in the laboratory.     Given the longstanding use and established safety record of metformin, the investigators will     evaluate the safety and efficacy of metformin for preventive treatment of high-frequency     episodic migraine in a randomized, double-blind, placebo-controlled, crossover trial.   "
52903|NCT02593084|"     Exercise programs, particularly resistance training programs using weights or resistance     bands, can help improve or maintain mobility and function in older adults, preserve     independent living, and improve quality of life. This study will examine the safety and     feasibility of a novel, higher intensity resistance training program in older adults, and     compare the effects with standard care, lower intensity training. It is anticipated that both     programs will be safe and feasible, but higher-intensity training will lead to greater     improvements in quality of life, mobility and strength, which are part of the physical     phenotype definition of frailty and markers of mobility disability.   "
52904|NCT02593071|"     This study will enroll subjects who received the RSV F vaccine or placebo in the earlier     study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a     second season. This design will permit evaluation of the safety and immunogenicity of     revaccination in a second RSV season, and the safety and immunogenicity of revaccination over     two years.   "
52905|NCT02593058|"     This study evaluates the addition of a 8 session psychological program, called Positive     Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with     schizophrenia. Half of the participants will receive their usual treatment and PEPS in     combination, while the other half will receive usual treatment only.   "
52907|NCT02593032|"     Medication adherence is defined as the extent to which a patient takes his or her medication     as prescribed by their healthcare provider. One third to one half of all patients in the     United States do not take their medication as directed, resulting in nearly $100B in     avoidable hospital costs per year. Recent efforts to improve medication adherence in patients     with multiple comorbidities have turned to case management and disease management programs.     Connected monitoring devices offer an alternative- or supplement- to frequent nurse visits     and outreach. These devices enable frequent monitoring and intervention but can also generate     large volumes of data that can be difficult for care teams to manage. The present study     explores the use of one such device- a technology-enabled, connected pillbox. Given the     continued emphasis on bending the cost curve in US healthcare, clinical validation of tools     that may improve the management of costly chronic diseases, such as diabetes, is essential.   "
52908|NCT02593019|"     AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein     tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2     (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.      CDK1 (also called cell division cycle 2, or CDC2) activity drives a cell from the G2 phase of     the cell cycle into mitosis. In response to DNA damage, Wee1 inhibits CDK1 to prevent the     cell from dividing until the damaged DNA is repaired (G2 checkpoint arrest).      Inhibition of Wee1 is expected to release a tumor cell from chemotherapeutically-induced     arrest of cell replication. In vitro experiments demonstrate that AZD1775 has synergistic     cytotoxic effects when administered in combination with various DNA damaging agents that have     divergent mechanisms of action. Therefore, the primary objective of the clinical development     of AZD1775 is its use as a chemosensitizing drug in combination with a cytotoxic agent (or     combination of agents) for treatment of advanced solid tumors.      CDK2 activity drives a cell into, and through, S-phase of the cell cycle where the genome is     duplicated in preparation for cell division. Inhibition of Wee1 is expected to cause     aberrantly high CDK2 activity in S-phase cells which, in turn, leads to unstable DNA     replication structures and ultimately DNA damage. Therefore, it is anticipated that AZD1775     will have independent anti-tumor activity in the absence of added chemotherapy.      The tumor suppressor protein p53 regulates the G1 checkpoint. As the majority of human     cancers harbor abnormalities in this pathway they become more dependent on S- and G2- phase     checkpoints. Thus, S- and G2-checkpoint abrogation caused by inhibition of Wee1 may     selectively sensitize p53-deficient cells.      One hundred percent of Small cell lung cancer has TP53 mutation, therefore we can expect that     most of Small cell lung cancer have lost G1 checkpoint and has high probability of WEE1     dependency for proper DNA repair and cell cycle progression. For this reason, Small cell lung     cancer could be a good clinical trial target disease for WEE1 inhibitor.   "
52909|NCT02593006|"     STOP-JIA is a PCORI funded prospective observational study which will compare the clinical     effectiveness and impact on patient reported outcomes of 3 Childhood Arthritis & Rheumatology     Research Alliance (CARRA) consensus derived treatment strategies (CTPs) in new-onset     polyarticular JIA (pJIA) patients to answer the critical question of when is the best time to     begin biologic medications to achieve the optimal clinical and patient reported outcomes.     Because the CARRA Registry will be used for data collection, all patients will be enrolled in     the CARRA Registry. The standard of care treatments are chosen by the treating physician and     patient/caregiver and are not randomized.   "
52910|NCT02592993|"     Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars     treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.   "
53346|NCT02587325|"     mTOR activation has been shown to be relevant in the development and progression of pulmonary     hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension     in animal models. ABI-009 is an albumin-bound mTOR inhibitor with improved penetration in     lung tissue.   "
52911|NCT02592980|"     Background: Time in therapeutic range (TTR) is a measurement of quality of warfarin therapy     and lower TTR values (<50%) are associated with greater risk of thromboembolic and bleeding     events. Recently, the investigators developed a pharmacogenetic-based warfarin dosing     algorithm specifically calibrated for a Brazilian patient sample. The newly developed     algorithm was shown to be more accurate for individuals from the Brazilian population than     algorithms developed from international samples. The aims of this study are: to evaluate the     impact of a genetic-based algorithm, compared to traditional anticoagulation, in the time to     achieve the therapeutic target and in TTR percentage; and to assess the cost-effectiveness of     genotype-guided warfarin dosing in a specific cohort of patients with low TTR (<50%) from a     tertiary cardiovascular hospital. Methods/Design: The investigators will recruit 300 patients     with TTR<50% based on the last three INR values. At the first consultation, patients will be     randomized into two groups: TA (Traditional Anticoagulation) group and PA (Pharmacogenetic     Anticoagulation) group. For the first group, the physician will adjust the dose according to     current INR value and, for the second group, a pharmacogenetic algorithm will be used. At the     second, third, fourth and fifth consultations (with an interval of 7 days each) INR will be     measured and, if necessary, the dose will be adjusted based on guidelines. Afterwards,     patients who are INR stable will begin measuring their INR in 30 day intervals; if the     patient´s INR is not stable, the patient will return in 7 days for a new measurement of the     INR. The main outcomes will be the time to achieve the therapeutic target and the percentage     of TTR at 4 and 12 weeks. In addition, as a secondary end-point, pharmacoeconomic analysis     will be carried out. Discussion: With a sample size of 150 patients for each arm separately,     the study will have a power of 93% to observe a difference of 10% between TTR means of the TA     and PA groups. This randomized study will include patients with low TTR and it will evaluate     whether a population-specific genetic algorithm might be more effective than traditional     anticoagulation for a selected group of poorly anticoagulated patients.   "
52912|NCT02592967|"     The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of JNJ-64041757     a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two     virulence genes, which encode molecules that help cause disease, have been removed) when     administered intravenously to participants with advanced (Stage IIIb) or metastatic (Stage     IV) NSCLC (adenocarcinoma).   "
52913|NCT02592954|"     Adult participants will apply a broccoli sprout extract-jojoba oil compound to one arm every     night under occlusion for 1 week. Jojoba oil alone will be applied to the other arm. At the     end of 1 week, a 6mm punch biopsy will be taken from both arms and analyzed via polymerase     chain reaction (PCR) and immunohistochemistry for differences in various skin proteins.   "
52914|NCT02592941|"     The expanded access program will provide access to treatment with deflazacort in children,     adolescent, and adult patients with DMD in the U.S. who are ineligible, unable, or otherwise     unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new     drug application is under preparation and review. Enrollment is open to all eligible     patients.   "
52931|NCT02592720|"     This is a randomized, single blind, controlled study of intracoronary cocktail injection     before fractional flow reserve (FFR) measurement when guiding percutaneous coronary     intervention (PCI) in patients with acute coronary syndrome (ACS).   "
52932|NCT02592707|"     The purpose of this clinical phase I/II study is to investigate the safety and tolerability     of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs).     Secondary objectives of these study are the assessment of biodistribution, dosimetry and     preliminary efficacy of 177Lu-OPS201.   "
52933|NCT02592694|"     This is a randomized, double blind, placebo controlled study of intracoronary cocktail     injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation     myocardial infarction patients treated with primary angioplasty.   "
52915|NCT02592928|"     Background/Aims There is evidence indicating that deployment of forced spirometry (FS)     testing in a collaborative scenario, encompassing respiratory specialists and community     professionals, generates healthcare efficiencies. The study describes the roadmap for     regional implementation of the FS program in Catalonia (ES), from January to December 2016.      Methods/Design Firstly, the FS program will be deployed in three healthcare sectors (514 k     inhabitants), following Plan-Do-Study-Act iterative cycles, using the Model for Assessment of     Telemedicine for evaluation purposes. Thereafter, regional deployment of the FS program (7.5M     inhabitants) will be conducted. The third step considers: evaluation of transferability,     preparation for data analytics and recommendations for long-term assessment of outcomes. Main     components of the FS program are: i) Automatic quality testing; ii) Standardized data     transfer to a shared electronic health record; iii) Elaboration of individual FS reports     including historical results; and, iv) Clinical decision support systems providing access to     the FS report, and to remote support upon request.      Discussion/Conclusions The project constitutes the first attempt to scale-up a collaborative     scenario for FS testing that will open new avenues for longitudinal lung function assessment.     Moreover, the setting shows high potential for transferability to different sites and to     other diagnostic procedures.   "
52916|NCT02592915|"     The purpose of this study is to assess the effect of IV clonidine administration on lower     limb spinal motoneuron excitability during standardized total intravenous anesthesia     (propofol and remifentanil).   "
52917|NCT02592902|"     The purpose of the study was to determine, whether patients with recurrent respiratory     papillomatosis (RRP) suffer from extra oesophageal reflux more often than patients with     laryngeal cyst (control group).   "
52918|NCT02592889|"     Functional mitral regurgitation (FMR) is a common finding in patients with dilated     cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a     relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Cardiac     resynchronization therapy (CRT) has been shown to be effective in patients with dilated     cardiomyopathy and reduced LVEF. In selected patients, CRT has been linked to clinical     improvement and reduced mortality. Importantly, 38% of patients with clinical indication for     CRT present moderate or severe (FMR). Although FMR might be reduced after CRT, the     persistence of a relevant FMR (≥2) after CRT ranges between 40% and 50% and is an independent     predictor of no clinical response. In these patients, surgical FMR correction is frequently     turned down as a result of a high surgical risk. Percutaneous repair of the mitral valve with     the MitraClip system has demonstrated promising results in patients with dilated     cardiomyopathy and reduced LVEF5. In a cohort of patients with no response to CRT and FMR ≥2,     Auricchio et al showed significant clinical improvement with LVEF recovery and reduction in     left ventricle (LV) volumes after MitraClip. The absence of randomization, the retrospective     nature of the study and the subsequent selection biases were however major limitations that     impeded solid conclusions. The objective of the present study is to assess the efficacy and     safety of the MitraClip system in non-responders to CRT and FMR ≥2.   "
52919|NCT02592876|"     The purpose of this randomized, open-label study is to evaluate the safety and efficacy of     denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when     compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large     B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be     candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1     ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or     RICE alone. The study will assess whether there is a difference between the 2 groups in the     side effects that are reported and the number of patients who achieve complete remission at     the end of their study treatment.   "
53033|NCT02591394|"     The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic     designed for stroke patients and was established to provide a comprehensive approach to     stroke risk factor reduction. The goal of this study will be more effective than usual care     at reducing blood pressure in patients with poorly controlled blood pressure after an     ischemic or hemorrhagic stroke or transient ischemic attack.   "
52920|NCT02592863|"     Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular     dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older.     The symptoms have a severe impact on affected individuals with detrimental effects on work,     travel, social and family life. These patients see doctors often with no relief in their     symptoms.      The most promising help for these patients is to use medication that will increase blood flow     to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood     flow.   "
52921|NCT02592850|"     Tension-type headache (TTH) is a very common primary headache disorder, with important costs     for both patients and society. Often these patients are not willing to take prophylactic     medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT)     is an interesting option in such field, since it is characterized by a low profile of side     effects.      In this study the investigators will assess the efficacy of OMT (semi-structured evaluation     and black box treatment) in frequent Episodic TTH (ETTH) in an outpatient setting.     Preliminary data for power calculation are already available (Rolle et al. 2014), and the     investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind,     sham-controlled design.   "
52934|NCT02592681|"     This study is designed to make comparisons between acupuncture and acupressure for preventing     menstrual migraine (MM). Whether acupuncture is superior to acupressure is the most     interesting point of this study. First of all, females will be screened for eligibility.     Then, all participants who meet the inclusion criteria will be asked to keep a headache     migraine diary for three months as baseline data. The diaries will then be collected before     the first treatment. Then, all the participants will receive the corresponding interventions     on the eighth, fifth and second days before the estimated first day of menstruation     (determined individually from the diaries) in each month for three months (menstrual cycle),     making a total of nine treatment sessions. After the whole treatments, there will be a     three-month follow-up period. All the participants will be asked to complete the headache     diaries every month from baseline to the end of the study. The diaries recording data from     the fourth to the ninth month will then be collected at the end of the ninth month for the     second time indicating the end of the study for the participants. In case of an acute     migraine attack, participants will not be restricted from using normal medications.   "
52922|NCT02592837|"     Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an     excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides     needle aspirate samples which are often adequate for cytological examination only. More     advanced histopathological and immunocytopathological assessment of tissue samples, which is     particularly important in the diagnosis and staging of cancer, is often not possible with the     small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration needle     (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more     flexibility at the distal end, allowing better access to some lymph nodes stations. This     needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of     EBUS-TBNA highlighted above by providing tissue adequate for histological assessment rather     than cytological assessment alone.      This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the     diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA     needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or     more invasive surgical biopsies, without causing an increase in complication rates. Patients     with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to     have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel     Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month     period.   "
52923|NCT02592824|"     The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery reduces     the risk of postoperative heart failure as measured by plasma NT-proBNP in patients     undergoing moderate to high-risk coronary artery bypass graft surgery. Patients accepted for     coronary artery bypass surgery of at least two vessel disease or left main stenosis with or     without concomitant procedure and considered to be at moderate to high surgical risk     preoperatively with regard to postoperative heart failure will be studied. The primary     endpoint is postoperative increase of NT-proBNP from the day before surgery to the third     postoperative day.   "
52924|NCT02592811|"     Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in     approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical     lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones.     Because of inconstant success, high cost, and length of procedure, an alternative method was     proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the     safety of ESLBD is accepted in all recent published studies, it remains controversial wether     ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones.     Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.      The purpose of this prospective comparative multi center randomized study is to evaluate the     superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large bile     duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic strategy.   "
52926|NCT02592785|"     Primary objectives of this study are to assess the safety and tolerability of BAY 1163877 in     Japanese subjects with refractory, locally advanced or metastatic solid tumors and to     characterize the PK of BAY 1163877   "
52927|NCT02592772|"     This study examines the potential effect of reducing nicotine content or menthol or both in     men. It will also examine whether there are gender differences in manipulating tobacco     flavors and nicotine concentrations in cigarettes on smoking behavior.   "
52928|NCT02592759|"     The purpose of this study is to evaluate the therapeutic effects of smart glove which is     motion-based program designed for upper extremity rehabilitation after stroke.   "
52946|NCT02592525|"     This study will train health providers in home care teams across Quebec in shared decision     making about the decision to stay at home or move to another location. This decision is one     of the toughest for older Canadians. Decisions that are informed, shared and supported     produce better results. An interprofessional approach to shared decision making is when older     persons and their caregivers are supported by not just one but by all the professionals     involved in their care.The impact of the training program in interprofessional shared     decision making (IPSDM) above that of the passive dissemination of a decision guide will be     assessed by measuring to what extent older persons caregivers say they took active part in     the decision-making process.      Other outcome measures will be:      i) what option they chose, whether they feel conflict or regret about their decision, and the     burden of care they feel; ii) the quality of life of clients;   "
64653|NCT02439411|"     The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in     overall survival, response rates and toxicity in both programs.   "
52929|NCT02592746|"     Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in     the last decade there was no major improvement of hormonal therapy specifically for     premenopausal metastatic breast cancer. The median age of breast cancer is much younger, and     the proportion of young breast cancer (YBC) patients (less than 40) including premenopausal     women is much higher, in Asia, including Korea.      Capecitabine, the comparator in this trial, is an orally-administered fluoropyrimidine     derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients.     Palbociclib is a CDK4/6 inhibitors, in combination with endocrine therapy showed marked     advance in hormone receptor-positive MBC in the post-menopausal setting. After a median     follow-up of 16.5 months, preliminary results from Part 1 of this Phase 2 trial suggest that     the combination of PD-0332991 with letrozole is superior to letrozole alone, and improved     objective response and disease control rates (52% vs 32% and 76% vs 47%, respectively) in     patients treated with the combination. These remarkable results may contribute to have much     benefit with endocrine therapy for premenopausal women. Most importantly, recent PALOMA-3     trial revealed superior results of adding palbociclib to fulvestrant (median PFS 9.2 vs 3.8     months, P<0.001).      Based on these rational backgrounds, the purpose of this phase II study is to assess the     safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in     combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive     advanced breast cancer patients   "
52930|NCT02592733|"     This is an observational trial to determine if use of fusion imaging in infrarenal     endovascular aneurysm repair will decrease the radiation dose and improve patient safety for     this procedure.   "
53313|NCT02587754|"     This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants     with Parkinson's Disease. Half of participants will receive real acupuncture while the half     will receive placebo acupuncture.   "
52935|NCT02592668|"     This is a feasibility study to test the use of epidural stimulation to restore volitional     function previously lost due to spinal cord injury.      Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic,     have shown that direct electrical stimulation of the spinal cord increases the excitability     of spared neuronal connections within the site of injury, thereby enhancing signal     transmission and allowing recovery of previously lost volitional function. Recently, epidural     electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord     injury (SCI) has restored motor and autonomic function below the level of injury. Despite     positive results, further translational research is needed to validate these findings. The     goal of this proposal is to perform epidural stimulation to restore volitional function in     patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal     aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program     of daily physical rehabilitation, treadmill step training, and epidural stimulation to     recover motor, sensory, and autonomic function.   "
52936|NCT02592655|"     This cross-over study of twenty five (anticipated) healthy human subjects will utilize two     active control devices, and two different widths of the investigational device. One active     control is representative of the usual care tourniquet applied in hospital settings. The     second active control is a windlass tourniquet representative of the pre-hospital and     military usual care tourniquet device. Two inch and four inch widths of the investigational     device will be evaluated. The purpose of this study is to characterize and compare     investigational and control tourniquet safety and efficacy. All tourniquets will be applied     to the upper thigh. Efficacy data is provided by the presence or absence of popliteal flow     when assessed with ultrasound. Mapping of interface pressures between the skin and the     tourniquet will provide safety data. A minimum washout of five minutes will be allowed     between tourniquet applications. All interventions will be applied in one visit. No follow up     visit is anticipated.   "
52947|NCT02592512|"     This study evaluates the difference between Non Invasive Ventilation with Neurally Adjusted     Ventilatory Assist (NIV-NAVA) and Conventional Non Invasive Ventilation with Pressure Support     (PS) or Pressure Control (PC). All the patients are ventilated in each mode for 4 hours.     Afterwards they will be subjected to a semi-structured interview where they will be asked to     compare the two modes. The hypothesis is that NIV-NAVA will correct patients power of     Hydrogen (pH), PaCO2 og PaO2 more quickly than NIV-PS and NIV-NAVA is more comfortable for     the patients.   "
52948|NCT02592499|"     The study is a prospective, randomized, non-blinded, national, multi-center study. The study     will consist of the assignment of eligible patients to treatment with either a HeartMate III     (HM III) left ventricular assist device system or to pharmacological treatment (optimal     medical management, OMM) according to current guidelines. One hundred and forty (140)     patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III     and OMM.   "
52938|NCT02592629|"     The specific aim of this prospective study is to determine whether local anesthetics prior to     subacromial steroid injections reduce pain and consequently if they are cost-effective in the     treatment for shoulder pathology.   "
52939|NCT02592616|"     Four months of interval walking (IW) training results in substantial weight loss in     opposition to energy-expenditure matched continuous walking (CW) training. The reason for     this is unclear.      This study will assess if IW leads to greater exercise-induced suppression of appetite and ad     libitum food intake compared to CW and no exercise.      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled     study, where each subject will undergo three trials. Trials will be identical except the     following interventions:        1. One hour of rest (CON)        2. One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow          walking; IW)        3. One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.      After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal),     with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin,     Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised     ad-libitum meal test will be served and intake will recorded. Free-living energy intake via     food records will be assessed during the following 32 hours.   "
52940|NCT02592603|"     Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS     patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic     surveillance in specialized centers. Proximal serrated lesions are endoscopically challenging     to detect due to their unremarkable morphology. Endocuff is a novel device comprised of a cap     with a row of finger-like projections with a unique dynamic shape that help to flatten     mucosal folds during withdrawal of the instrument in order to improve detection of lesions.     Recent studies have reported an increase of detection rate and mean per patient of adenomas     with Endocuff-assisted Colonoscopy compared with Standard Colonoscopy. The purpose of this     study is to assess the usefulness of Endocuff-assisted Colonoscopy to detect serrated lesions     in SPS patients undergoing surveillance compared to Standard Colonoscopy in a randomized     fashion   "
52941|NCT02592590|"     The purpose of this study is to determine the individual and combined effectiveness of two     smartphone-based tools for improving physical activity. The first is an individualized and     guided goal-setting module, and the second uses points, levels, and badges to provide     instant positive feedback throughout the program. It is hypothesized that both components     will be effective, and greater effects will be noted for those receiving both components.   "
52960|NCT02592343|"     The primary goal is to study patients with recurrent Clostridium difficile Infection (CDI)     treated with lyophilized Fecal Microbiota Transplantation (FMT) in an open-labelled     controlled trial. The treatment failure rate will be evaluated as defined by the persistence     of diarrhea and a positive C. difficile toxin assay. The safety, clinical response, and     relapse rate in patients will be assessed.   "
52961|NCT02592330|"     The main aim of the study is to determine the safety and feasibility of a cultivated     autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem     cell deficiency.   "
52962|NCT02592317|"     The purpose of this study is to evaluate the effects of repeat dosing of JNJ-56021927 on the     pharmacokinetics for single-dose multiple cytochrome P450 (CYP450) enzymes (CYP3A4, CYP2C9,     CYP2C19, CYP2C8) and transporter (P-gp and BRCP) substrates in participants with     castration-resistant prostate cancer (CRPC).   "
53314|NCT02587741|"     Diabetic retinopathy (DR) is an important cause of blindness.   "
52942|NCT02592577|"     This first time in human study is intended for men and women at least 18 years of age who     have advanced lung cancer which has grown or returned after being treated. In particular, it     is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and     a tumor test positive for MAGE A10 protein expression (protein or gene). The study will take     the subject's T cells, which are a natural type of immune cell in the blood, and send them to     a laboratory to be modified. The changed T cells used in this study will be the subject's own     T cells that have been genetically changed with the aim of attacking and destroying cancer     cells.      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back     to the subject through an intravenous infusion. The purpose of this study is to test the     safety of genetically changed T cells and find out what effects, if any, they have in     subjects with lung cancer. The study will evaluate three different cell dose levels in order     to find out the target cell dose. Once the target cell dose is determined, additional     subjects will be enrolled to further test the safety and effects at this cell dose.      Subjects will be seen frequently by the Study Physician right after receiving their T cells     back and up to first 6 months. After that, subjects will be seen every three months. If     subjects have disease progression or withdraw from the study, they will then be entered into     a long-term follow up for safety monitoring. Subjects will be seen every 6 months by their     Study Physician for the first 5 years after the T cell infusion. If the T cells are found in     the blood at five years, then the subjects will continue to be seen once a year until the T     cells are no longer found in the blood for a maximum of 15 years. If the T cells are no     longer found in the blood at 5 years, then the subject will be contacted by the Study     Physician for the next 10 years.   "
52944|NCT02592551|"     The objective of this study is to determine whether MEDI4736 or combination therapy with     MEDI4736 + tremelimumab are associated with favorable alterations of the intratumoral     immunologic environment in subjects undergoing resectional surgery for Malignant Pleural     Mesothelioma MPM.   "
52945|NCT02592538|"     Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a     beneficial treatment option for palliation of malignant biliary strictures. RFA uses a     high-frequency alternating current to generate heat and achieve coagulative necrosis when in     contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased     tumor ingrowth. However, most of therapeutic effects were expected to delay bile duct     obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic     agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct     adenocarcinoma. To date, little is known about the role of the addition of systemic     chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate the combined     effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.   "
52949|NCT02592486|"     The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and     pneumococcal vaccine was unknown. The purpose of present study is to compare the     immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine     with that of separate administration.   "
52951|NCT02592460|"     Animal studies have shown that the level of pain sensitivity is highly dependent on the     amount of polyamines in food. This fundamental observation of a nutritional approach to pain     led the authors to develop diets completely depleted in polyamines whose anti-nociceptive     properties have been confirmed in animals.      Postoperative pain after foot surgery are currently fairly well controlled but at the cost of     a high consumption of grade II analgesics which is associated with a high rate of side     effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in     polyamines may have an additive effect on pain control and reduce the consumption of level 2     analgesics.      The objective of this study is to show the efficacy of a polyamines-poor diet on     postoperative pain in ambulatory surgery of the foot.   "
52952|NCT02592447|"     The purpose of this study is to evaluate Cognitive Behavioral Intervention for Targeted     Therapy Fatigue (CBT-TTF) with fatigued chronic myelogenous leukemia (CML) patients on     tyrosine kinase inhibitors (TKIs) for feasibility, acceptability and potential efficacy     relative to usual care only in a small-scale randomized controlled trial.   "
52953|NCT02592434|"     Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.   "
52954|NCT02592421|"     In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in     plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP     following SGLT2 inhibition.   "
52955|NCT02592408|"     This is a randomized controlled trial to assess the efficacy and safety of the national     malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine -     pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and     the hematologic effect of 14 days routine primaquine based radical cure in patients suffering     from a P. vivax or mixed infection.   "
52956|NCT02592395|"     The purpose of this study is to see how well electrochemotherapy works at treating people     with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines     electroporation and chemotherapy administration. Electroporation uses an electric current to     produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher     concentration of administered chemotherapy agent. This study will test the safety and look at     the effect of electrochemotherapy in the treatment of stage III pancreatic adenocarcinoma.     This study will also help to find the safest and most effective amount of electroporation     voltage to apply to this type of tumor.   "
52957|NCT02592382|"     Acute otitis media (AOM) is one of the most prevalent and costly illnesses in children     throughout the world. AOM can lead to chronic otitis media with effusion (OME) resulting in     conductive hearing loss that can cause speech, language, academic, and social developmental     delays.      Complementary and alternative medicines are being widely used for prevention of AOM.      Xylitol is a five carbon polyol (sugar alcohol) produced from natural plants and is used for     preventing dental caries and AOM in children. It is commercially available in chewing gums,     syrups and toothpastes washes, and other products. Xylitol was shown in several studies to     prevent the culture if bacteria in the nasopharynx and oral cavity. It was proven to     eliminate the ability of bacteria to attach to the mucosa of the upper respiratory system.      In this study the investigators aim to test the yield of Xylitol nasal spray compared to     isotonic saline spray in prevention of recurrent AOM.   "
52958|NCT02592369|"     Prospective, single arm, multi-center, observational, post market study to document the     clinical and device performance outcomes of the Evolut R system used in routine hospital     practice in a large patient cohort for the treatment of symptomatic native aortic valve     stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure     necessitating valve replacement.   "
52959|NCT02592356|"     The goal of this clinical research study is to learn about possible weight, muscle, and/or     fat loss in patients receiving cabozantinib or lenvatinib.   "
55772|NCT02555618|"     The purpose of this study is to evaluate the immunogenicity and safety of TAK-850     administered subcutaneously as a single dose versus influenza HA vaccination in an     exploratory manner.   "
52963|NCT02592304|"     Endpoints subproject 1: To develop a reproducible method for the detection of lymph nodes by     DECT in operation specimens from rectal resection for cancer. sub project 2: Primary     endpoint: To evaluate the sensitivity and specificity for malignant lymph nodes in vitro RC     specimens compared with histopathology. Secondary endpoint: To assess DECT as imaging tool     for the diagnosis of malignant lymph nodes at RC. Histopathology will be used as     reference.Subproject 3: Primary endpoint: To compare the sensitivity, specificity, positive-     and negative predictive values, accuracy of DECT and standard MRI. Secondary: To evaluate the     value of the gold standard for the use of imaging methods for the description of the lymph     node, validated by histopathology. Secondary: to determine the value of tumor diagnostics     using DECT.subproject 4: To assess the value of DECT as imaging tool for diagnosing response     to chemo radiotherapy of malignant lymph nodes.   "
52964|NCT02592291|"     This study will assess the benefits of using mobile health system designed for individuals     with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral     Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and     self-management skills compared to those who receive standard of care only.   "
52976|NCT02592135|"     The purpose of this study is to better understand myocardial injury in AHF. Secondary     analyses demonstrate the prognostic significance of troponin release. The absence of such     release has been associated with less risk. Whether measurement of high sensitivity TnT may     enable emergency physicians to better risk stratify acute heart failure patients remains to     be determined. This study will help us to better understand the prognostic value of absent or     low hsTnT values in the emergency department setting. In addition, we will also test the     STRATIFY decision rule; a risk score.   "
52965|NCT02592278|"     The aim of this study is to determine the effectiveness of fluoride varnishes in the     prevention of dental caries lesions in erupting permanent first molars, in high-risk     patients. Using as reference ICDAS criteria, when the success means that the surface maintain     an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.      Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental     caries.      Study design: It proposed an experimental design randomized into 3 groups according to the     frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month;     Group C: positive control).   "
52966|NCT02592265|"     The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a     new point of view that includes consequences of disability on Quality Of Life (QOL), social     participation and capabilities of patients and caregivers. To the investigators' knowledge,     there is currently no data including intangible costs related to caregivers and calculating     the overall economic cost of Multiple Sclerosis, particularly, in France.   "
52967|NCT02592252|"     Violence against women and girls is increasingly recognized as a major global public health     and development concern. However, evidence on what forms of intervention should be     prioritised is severely lacking. A cluster randomized controlled trial (The Intervention with     Microfinance for AIDS & Gender Equity - IMAGE Project) in rural South Africa combined a     group-based microfinance intervention with a participatory gender and HIV training curriculum     for loan participants and showed that, over a two-year period, levels of physical and/or     sexual partner violence experienced by participants in the past year were reduced by 55%.      The overall goal of the current study is to design and implement a cluster randomized     controlled trial to assess the impact on intimate partner violence of: 1) combining     participatory gender training with microfinance for women in existing microfinance loan     groups, and 2) a participatory gender training programme for women (not receiving     microfinance) and their male partners.   "
52968|NCT02592239|"     The purpose of this study is to determine the relationship between brain activity and the     perception of subjective hedonic sensations in response to a meal using functional MRI.   "
52969|NCT02592226|"     The ventilation of the patient under general anesthesia is an old problem and extensively     studied, especially in visceral surgery, higher risk of postoperative complications. Studies     have recently shown the impact of a lung-protective ventilation in visceral surgery, however     obese patients are often excluded, and alveolar recruitment maneuver has never been studied     independently.      The investigators are conducting a randomized controlled prospective study to investigate the     clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing     bariatric surgery.      The objective is to show the reduction in dyspnea, oxygen dependency: reflection of     atelectasis and the incidence of postoperative complications.   "
52970|NCT02592213|"     Breast cancer is the most common cancer type among women. Treatment in many cases involves     axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema     development which occurs in up to 30% of such cases. The present treatment paradigm is     conservative with compression garments. There is a need for more effective treatment options     and regenerative medicine offers hope for a change to a more curative approach. This Phase 2     trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived     stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.   "
52971|NCT02592200|"     The primary objective is to determine the change in frequency of complete spontaneous bowel     movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123     in healthy adult women with functional constipation.   "
53002|NCT02591797|"     This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio     will be to evaluate the effectiveness of Hands/Eyes/mouth behavior management technique     versus a conventional technique (covering the patient´s vision) during an inferior alveolar     and lingual nerve block in preschool children referred for treatment at the School of     Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52     children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or     tooth extraction of primary molars. Preschool children with no history of allergies to     Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the     study will be include in this research.   "
53003|NCT02591784|"     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     efficacy has been shown in adult with head and neck cancer. The phase II study assessed the     efficacy and safety of the combination of Nimotuzumab administered concomitantly with     radiotherapy in patients with esophageal cancer tumours.   "
52972|NCT02592187|"     Background: Mild Cognitive Impairment (MCI) is a risk factor for dementia and represents a     critical window of opportunity to intervene and alter the trajectory of both cognitive and     functional decline. Emerging life-logging technologies has shown a tremendous potential to     increase autobiographical memory.      Objective: The main goal of the present study is to develop a Cognitive Training program (CT)     for MCI based on life-logging captured by a Wearable Camera (WeC) recording specific     autobiographical episodes for stimulating posteriorly episodic memory. The challenge is to     create an application to manage this large collection of images, which can be easily     retrieved as events by users in a therapeutic context as a multimodal cognitive stimulation.     The investigators will conduct the first pilot Randomized Controlled Trial (RCT) evaluating     the effectiveness of the life-logging re-experiencing program immediately and 3-month     follow-up period.      Methodology: The Design is a single blind RCT of CT based on life-logging tools. 30 adults     with MCI, after completion of two weeks image collection by a WeC, will be randomly allocated     (1:1) into experimental or control group. Once acquire episodic individual's videos, all     participants will attend 1-hour individual training sessions 2 times per week for 14 weeks.     Main outcomes measures will be cognitive, functional, emotional and quality of life measures,     as well as biochemical measures (BDNF).      Expected results: The investigators expect the outcomes to provide preliminary evidence that     autobiographical experimentation CT programs can positively impact cognitive functioning and     may represent an effective strategy to improve memory and functionality in those who begun to     experience cognitive decline.   "
52973|NCT02592174|"     The primary objective is to measure the prevalence of according to the Frascati     classification in a HIV-infected population aged between 55 and 70 years (exposed group) and     to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in     unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on     age, gender, geographical origin and socioprofessional category.   "
52974|NCT02592161|"     A randomized, single center, double blind, parallel, placebo-controlled, clinical study of     efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the     improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis.   "
52975|NCT02592148|"     There is an interest to assess nutritional status of vitamins in humans in a non-invasive     way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to     blood for this purpose. The suitability of saliva for status determination will be     investigated by analysis of (forms of) vitamins A and E, B1, B2, B3, B6 and C in both saliva     and blood.   "
54644|NCT02570373|"     The purpose of this study is to characterize the elimination of guselkumab glycoform variants     following a single intravenous (IV) administration of guselkumab at a 10 milligram per     kilogram (mg/kg) dose in healthy participants.   "
52977|NCT02592122|"     In the patients with COPD mechanical ventilation, the bronchial dilatation is very common.     However, the evaluation of the efficacy of the medical examination and other subjective     indicators, such as doctors, depends on the doctor's experience; at present, there is no     objective evaluation index. For patients with mechanical ventilation, the risk of cross     infection can not only increase the risk of cross infection, but also increase the workload     of clinical doctors and nurses. Therefore, this study proposes an objective evaluation method     to evaluate the response of COPD patients to bronchial dilation. The hypothesis of this study     can be used to guide the clinical medication through the test of the bronchus. If the     patients with bronchial dilation test positive were used in the test, the patients were not     used. In this evaluation method, the changes of airway resistance were measured by the     accurate measurement of the patients with inhaled bronchial dilatation.   "
52978|NCT02592109|"     The epidemic of pediatric obesity has become a public health burden in both developed and     developing countries, due to its serious health consequences, including an increased risk of     type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are still     the center of preventive and treatment measures of obesity. Recently, the omega-3 group, one     of the groups of polyunsaturated fatty acids (PUFAs), has been associated with many positive     effects leading to the improvement of many diseases related to obesity. Nevertheless, the     consumption of this essential nutrient requires certain ration to optimize its favorable     result. Although previous studies have examined the efficacy of dietary counseling approach     as treatment for obesity, none of them as explicitly explore the use of linear programming to     create a tailored diet containing high omega-3 fatty acid food as a part of dietary     counseling in obesity management program among children. Thus, this study is intended to     contribute the clinical evidence regarding this area of knowledge, specifically the effects     of enhanced counseling containing complementary feeding recommendation on nutritional status,     omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children with risk of     overweight aged 12 -23 months in East Jakarta.   "
52979|NCT02592096|"     To investigate the safety, tolerance, dynamic percolation model of single dose usage     pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic     suppurative otitis media   "
52980|NCT02592083|"     The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6     inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive     endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are     then randomized between either continuous endocrine therapy (arm A) or the same treatment     with addition of palbociclib (arm B). Patients with no change of proliferation are allocated     to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly     treatment period, clinical and radiological evaluations are performed repeatedly. Switch     between the treatment arms A and B is allowed in case of lack of response or due to toxicity.     A translational subprotocol is a mandatory part of the study protocol, except for use of     PET-CT evaluations.   "
53004|NCT02591771|"     The purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as     an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion     monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock,     including ventricular mechanical support.   "
53162|NCT02589717|"     This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to     provide atezolizumab access to participants with locally advanced or metastatic urothelial     carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy     regimen.   "
52981|NCT02592070|"     This study addresses an important public health concern; impoverished cognitive function     associated with treatment of breast cancer. Due to increased awareness of breast cancer     combined with advances in medical care, there are over 2.8 million women living with a     history of breast cancer in the U.S. alone. Chemotherapy and adjuvant therapy to remove     cancerous tissue can result in deficits in attention, speed of processing, memory, and     quality of life. Physical activity has been associated with a number of health benefits for     breast cancer survivors including improvements in cognitive function. However, most of the     literature is cross-sectional and it is unclear whether acute (single) bouts of physical     activity affect cognition and, if they do, how long this effect lasts. This study will be the     first, to the investigators' knowledge, to examine the effects of an acute bout of aerobic     exercise on cognitive functioning in breast cancer survivors. Specifically, the investigators     will determine the effects of a 30-minute moderate intensity aerobic exercise session     (treadmill walking) on immediate and one hour follow up changes in measures of processing     speed, memory, and executive function. Additionally, accelerometer cut-points for physical     activity intensities in breast cancer survivors will be assessed. Finally, the investigators     will examine the association of cardiorespiratory fitness and physical activity with changes     in cognitive function. Findings from this study will allow researchers to determine whether     any acute effects of exercise on cognition are retained over time and therefore have real     meaning in the context of one's daily life.   "
52982|NCT02592057|"     This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens     administered as per the approved prescribing information in adults with chronic hepatitis C     virus (HCV) infection treated in routine clinical practice in India.   "
52983|NCT02592044|"     The effect of aromatherapy with lavender essential oil on pain and anxiety during     venipuncture will be evaluated.   "
52984|NCT02592031|"     Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17     and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed     in human healthy female subjects. Only female subjects will be included in the study to reach     the objectives of the study.   "
52985|NCT02592018|"     This is a single-arm, open-label study, which will examine the effect of secukinumab on the     immunologic and genetic environment within psoriatic lesions.   "
52996|NCT02591875|"     The LEONARDO study is a non-randomized, multicenter, prospective study in which consecutive     patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled.     Patients can be treated with any market released catheter for ablation. The decision to     perform the ablation of AFL will be made based on clinical evaluation of the investigators     according to their clinical practice. The study does not require specific surgical     techniques. Patient time commitment for the study is approximately 12 months.The study has     been designed to describe the italian clinical practice in relation to the approach of AFL     ablation. In particular, the investigators will describe the methods for the validation of     ablation success, the techniques adopted, and the patient management approaches in the     participating centers.   "
52997|NCT02591862|"     Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to     Eculizumab due to complement C5 polymorphisms.   "
63627|NCT02452788|"     The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared     to usual care, in improving medication adherence behaviour of ambulatory hemodialysis     patients.   "
52986|NCT02592005|"     Introduction: An emerging body of evidence indicates that there is an association between air     pollution exposure in pregnancy and adverse pregnancy outcomes (Rudra, Williams, Sheppard ,     Koenig, & Schiff, 2011; Dadvand, et al., 2013; Ritz, et al., 2014). Adverse pregnancy     outcomes tend to lead to adverse neonatal outcome and a higher economic cost. Epidemiologic     studies have also revealed that cardiovascular complications during pregnancy, such als     preeclampsia, are associated with a greater cardiovascular risk during later life ( Abramson     & Melvin, 2014).      Aim: This study wants to examine the effects of exposure to environmental factors, polluents     and particulate matter on the clinical pregnancy outcome for mother and child and to     determine which biochemical changes in maternal, placental and cord blood best explain this     effect.      Methods: This study will be performed in a prospective cohort setup (n=200), recruited from     the prenatal clinic in the University Hospital Antwerp. The data collection consists of four     questionnaires (intake, both urine samples and postpartum), two blood samples (28 weeks and     post-partum), two urine samples (20 and 30 weeks), two hair samples (20 weeks and     post-partum), cord blood and the placenta.      Results and conclusion: As the study will start in November 2014, no results are available     yet.   "
52987|NCT02591992|"     To evaluate the safety and effectiveness of computed tomography angiography in the diagnostic     and therapeutic cycle as the first-choice method of imaging in the diagnosis of patients with     a high probability of stable coronary artery disease according to European Society of     Cardiology recommendations.   "
52988|NCT02591979|"     The purpose of this study is to develop and validate a work-model in Primary Health Care for     identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory     monitoring study.   "
52989|NCT02591966|"     The purpose of this study is to investigate effects of systemic treatments on genomic     profiles in patients with breast cancer and to compare genomic profiling between     premenopausal and postmenopausal women by systemic treatments in breast cancer.   "
52990|NCT02591953|"     Using randomization, prospectively determine superiority of either ultrasound-guided or     landmark-guided biceps corticosteroid injections with regard to various clinical variables.   "
53016|NCT02591615|"     This is a multicenter randomized phase II to determine if the administration of standard     platinum-based chemotherapy before MK-3475 in with Chemotherapy naive stage IV Non-small Cell     Lung Cancer (NSCLC) will improve the overall response rate (ORR) compared to MK-3475     administered before chemotherapy. Patients will be given Pembrolizumab as maintenance up to 1     year: Carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by     pembrolizumab every 3 weeks for up to 1 year. Pembrolizumab every 3 weeks x 4 cycles followed     by carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by     pembrolizumab every 3 weeks for up to 1 year.   "
53163|NCT02589704|"     This is a single visit, non-interventional, cross sectional study about risk factors,     etiology, nutritional status and feeding methods in CP patients.   "
52991|NCT02591940|"     CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous virtual     physiological human (VPH) projects and checks the applicability and effectiveness of     available predictive modelling and simulation tools, validating them in interrelated clinical     trials conducted in three European centres of excellence in cardiac treatment (from Germany,     Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and aortic     coarctation, which, if left untreated, can ensue irreversible heart failure. As a result     treatment becomes mandatory, but optimum timing and the best type of treatment still remain     difficult to determine. With more than 50.000 interventions per year within the EU, the     diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical     guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters,     without benefiting, as yet, from patient-specific disease modelling based prediction.     CARDIOPROOF goes beyond the current state of the art by conducting validation trials aimed at     covering and comparing the complete spectrum of cardiovascular treatment, predicting the     evolution of the disease and the immediate and mid-term outcome of treatment. Operational     clustering is going to provide a seamless clinical solution that applies different modeling     methods to realize the potential of personalised medicine taking into account     user-friendliness as a key component of clinical usability. CARDIOPROOF's goal is to provide     first-hand data on comparative cost-effectiveness and clinical efficacy of the most advanced     VPH approaches compared to conventional diagnostics and treatment algorithms, thus     accelerating the deployment of VPH methods in clinical environments, and bring to maturity     holistic patient-specific computer-based predictive models and simulations.   "
52992|NCT02591927|"     The purpose of this study is:        1. to assess whether pre-hospital glucose-insulin-potassium (GIK) administration in acute          STEMI patients would reduce infarct size and ischemia/reperfusion damage using          comprehensive tissue characterization by cardiovascular magnetic resonance (CMR) at an          early post-infarction phase.        2. to explore the putative cardioprotective mechanisms of pre-hospital GIK administration   "
52993|NCT02591914|"     The objectives of this study are to establish the safety and tolerability of intravitreous     administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered     in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with     subfoveal neovascular age-related macular degeneration.      Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three     months. Retreatment with Fovista™ and Anti-VEGF will occur if the following findings are     present PER INVESTIGATOR DISCRETION:        -  ≥ 5 ETDRS letters loss OR;        -  Significant hemorrhage OR;        -  New or increased RPE elevation consistent with increased disease activity OR;        -  Increased neovascular lesion size OR;        -  New or increased foveal intraretinal fluid      If anti-VEGF re-treatment is not administered based on the re-treatment criteria noted above,     Fovista™ anti-PDGF therapy MUST be administered at a minimum of every 3 months (as     monotherapy).      Therefore, subjects will be treated with Fovista™ or Anti-VEGF therapy for a total of 3-24     administrations.   "
52994|NCT02591901|"     Due to the damage caused to the spinal cord, patients with spinal cord injury, cauda equina     syndrome, multiple sclerosis and transverse myelitis may encounter loss of bladder function,     which in turn can lead to a debilitating and costly complication: Urinary Tract Infections     (UTIs). Given that these patients with loss of bladder function do not normally feel symptoms     like pain - as would be the case in otherwise healthy persons - there is no clear agreement     among experts on which signs and symptoms are indicative of a UTI. Although strong evidence     is lacking, antibiotics have been widely used for prevention of recurrent UTIs in patients     with loss of bladder function. However, this approach is now being questioned as antibiotic     resistance has become a world-wide health concern. Policy makers recently stressed the     importance of research into alternative preventative treatments. The use of vaccines is one     such an alternative approach, which works by stimulating the body's immune system. One of     these vaccines is a Uro-Vaxom® oral capsule which consists of inactivated traces of the     bacteria that normally cause at least 83% of UTIs in patients with loss of bladder function.     Previous studies show that Uro-Vaxom® resulted in a significant reduction of UTIs in     otherwise healthy patients, as well as being safe to use. Before investigating the effects of     this promising new vaccine, this proposed study aims to clarify two crucial issues. First,     after reviewing the literature and appraising patients', carers' and healthcare     professionals' experiences, the aim is to reach an agreement on how to measure a symptomatic     UTI in patients with loss of bladder function that results from a spinal cord lesion. Second,     using Uro-Vaxom® Investigators aim to conduct a smallscale, placebo-controlled trial with 48     participants to investigate the feasibility of carrying out a larger trial on prevention of     symptomatic UTI in such patients.   "
52995|NCT02591888|"     Liposomal bupivacaine or placebo will be administered at the end of a transobturator     midurethral sling to determine if there is a difference in a patient's perceived     postoperative pain.   "
52998|NCT02591849|"     Post-transplantation diabetes mellitus (PTDM) develops in 10-15 % of all renal transplant     recipients within 10 weeks after transplantation, and has been associated with increased risk     of cardiovascular disease and impaired patient survival. PTDM is primarily believed to be a     variant of type 2 diabetes mellitus (T2DM), but the pathophysiology underlying the impaired     glucose metabolism in renal transplant recipients with PTDM is unclear and some aspects are     still poorly investigated. Hyperglycemic clamp investigations with concomitant infusion of     glucagon-like peptide-1 (GLP-1) are warranted for a thorough characterization of the α-cell     and β-cell function.      The primary objective of the present study is to investigate whether hyperglucagonemia is     present in renal transplant recipients with PTDM. Furthermore, the investigators aim to     examine the insulinotropic and glucagon suppressive effects of GLP-1 (compared to placebo) in     PTDM patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic     clamp), respectively.   "
52999|NCT02591836|"     The primary purpose of this placebo-controlled study is to evaluate the low‐density     lipoprotein cholesterol (LDL‐C) efficacy and dose‐response of gemcabene 300, 600 and 900     mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day     to hypercholesterolemic patients.      Secondary purposes include evaluating the effects of high‐sensitivity C-reactive protein     (hsCRP), high‐density lipoprotein cholesterol (HDL‐C), triglycerides (TG) and apolipoprotein     B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin     combination.   "
53000|NCT02591823|"     Low dose methotrexate used in rheumatoid arthritis is considered very safe and has a side     effect profile very different from that seen with high dose methotrexate used in oncology.     Hair fall has been found to occur in high dose methotrexate but there is no data regarding     the same when methotrexate is used in low dose.Thus this observational case control study is     being undertaken to determine whether rheumatoid arthritis patients really need to be     concerned about hair fall when on low dose methotrexate.   "
53001|NCT02591810|"     This prospective randomized control trial (PRCT) aims to compare the outcome of three     treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without     concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the     most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs     open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.   "
53005|NCT02591758|"     The first and foremost manifestation of ischemic heart disease (IHD) is angina. At a global     level, patients with chronic angina are at risk of poor vital status and deconditioning.     Medical therapy and coronary revascularization using coronary artery bypass graft (CABG) or     percutaneous coronary intervention (PCI) can effectively relieve angina . In spite of all the     available treatment options, the assessment of angina remains a challenge. Angina has a     cyclical pattern and will naturally worsen and improve as days go by. Likewise, angina can be     significantly biased by the placebo effect. Clinically angina is most frequently quantified     with the Canadian Cardiovascular Society (CCS) classes system. In research protocols, angina     is often quantified with health-related quality of life questionnaires and diaries. None of     the tool available accounts for an important phenomenon called ischemic threshold adaptation,     which could be defined as a limitation of their activity level under the ischemic level,     which will translate into fewer angina episodes and a seemingly stable condition. Better     clinical assessment tools that take into consideration the ischemic threshold adaption are     needed.      Despite increased interest in wearable biometrics clothing in medicine, no prospective study     has documented their utility to assess angina and to monitor the rehabilitation in cardiac     patients. The Hexoskin™ is a biometric vest that can collect physiological data from     individuals in their natural daily living environment. Currently, the use of biometric     clothing is confined to a niche exploited exclusively by health enthusiasts, athletes or     astronauts. As we enter this new age of virtual healthcare, tools like wearable biometrics     could represent a giant leap forward in assisting healthcare professionals and patients. This     will translate a better assessment of their health status, will allow physicians to target     the right treatment strategy, ultimately improving case-selection and outcomes.      Our objective is to prospectively validate the wearable biometrics clothing Hexoskin™ against     established standards used to assess chronic stable angina. In addition, the investigators     want to derive a novel vitality index from the data generated by this device that will     subsequently be used to propose a new angina classification system that will account for     ischemic threshold adaptation. Moreover, the investigators want to evaluate the safety and     efficacy of Hexoskin monitor patients undergoing home-based cardiac rehabilitation.   "
53006|NCT02591745|"     This registry aims to gather anesthetic medications administered to fetuses directly as well     as those administered via the mother during fetal intervention procedures. The goal is to     assesss short and medium term outcomes as well as long term outcomes of these babies whao     have received medication in utero. The long term outcomes will include but are not limited to     neurodevelopmental outcomes.   "
53007|NCT02591732|"     The purpose of this study is to describe the characteristics of patients treated with     different OATs and whether these characteristics differ between treatments.      Furthermore to describe persistence to each OAT and risk of bleeding after initiating each     OAT.   "
53008|NCT02591719|"     The aim of this study is to assess the safety and clinical efficacy of repetitive     transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with     functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.   "
53388|NCT02586766|"     The purpose of this study is to determine whether a brief motivational interviewing     intervention given during emergency department care to 14-20 year olds seeking treatment,     could reduce youth violence.   "
53009|NCT02591706|"     Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be     compared. Implant success rate will be evaluated by measuring the peri-implant bone     remodeling from baseline to 1 year post insertion.      The hypothesis is those implant survival rates of the test (V3) and control group (C1) are     similar and that test V3 implant allows less peri-implant bone loss.      Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1     implants will be compared. The bone thickness will be measured in cone beam computerized     tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.      The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.   "
53010|NCT02591693|"     The purpose of this study is to determine whether a training intervention to improve     caregiver confidence for family caregivers of patients with palliative care needs at home, is     acceptable to patients and their caregivers.   "
53011|NCT02591680|"     Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during     ascent and descent stairs after the addition of neuromuscular training to hip muscle     strengthening.   "
53012|NCT02591667|"     There is a paucity of data on the histopathological response of peritoneal tumor deposits     from colorectal cancer to neoadjuvant chemotherapy. Particularly, no prospective assessment     of chemotherapy-associated histopathological response within the peritoneum has been     performed so far. Therefore, there is an urgent need to conduct a clinical trial aimed at     prospectively assessing the histopathological response within the peritoneum in patients with     peritoneal metastasis from colorectal cancer.      Recently, Loupakis et al. reported that the triplet regimen of 5-fluorouracil, oxaliplatin     and irinotecan (FOLFOXIRI) in combination with bevacizumab significantly improved median     progression-free survival in metastatic colorectal cancer patients from 9.7 to 12.1 months as     compared with fluorouracil, leucovorin, and irinotecan (FOLFIRI) + bevacizumab. In view of     these data, it is likely that FOLFOXIRI + bevacizumab will also lead to a significant     improvement of the histopathological response within the peritoneum of patients with     peritoneal metastasis from colorectal cancer (pcCRC) as compared with previous standard     chemotherapy.      The investigators hypothesize that FOLFOXIRI + bevacizumab will induce a pCR or major     response in peritoneal tumor deposits in >30% of patients (taking the response rate to     FOLFOX- or FOLFIRI-based neoadjuvant chemotherapy from the published literature as a     reference).   "
53013|NCT02591654|"     The purpose of this study is to test two imaging techniques, one called whole body (WB)     diffusion weighted (DWI) magnetic resonance imaging (MRI) (WB-DWI MRI), and another called     Fluorine-18 3'-deoxy-3'-fluorothymidine positron emission tomography (PET) (F-18-FLT PET).     The goal is to see whether these imaging techniques would allow the study doctors to see     changes in the size of a tumor earlier for patients with metastatic melanoma receiving     Pembrolizumab (MK-3475).   "
53014|NCT02591641|"     The purpose of this study was to examine the effectiveness of a shear reduction surface on     shear, pressure, and comfort used in pre-hospital ground transport.   "
53015|NCT02591628|"     This proposed pilot study will test methods and feasibility for a large pragmatic clinical     trial comparing two inexpensive, first-line drugs for treating high blood pressure to     determine if one is superior in preventing serious cardiovascular events and death. It will     develop and test novel approaches to conducting trials that will be faster, less expensive,     and more realistic by being embedded in a typical practice setting and using advanced health     information technology.   "
53028|NCT02591459|"     The objective of this work is to develop an application to run on a mobile device Android     tablet that features visual routines for autistic children.   "
55773|NCT02555605|"     This study aimed to determine the feasibility of dexmedetomidine in children with respiratory     morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.   "
53017|NCT02591602|"     Transporting radiology to the patient's home is challenging. Preliminary experiences     conducted in Turin (Italy) and Lund (Sweden) indicate that the coupling of simple,     light-weight X-ray equipments with a Computed radiography or Digital Radiography systems     could be effective for externalization of radiographic service.      The image and examination quality has been proved to be the same than those performed with a     stationary equipment and analysis on safety of radio-protection systems show a very low risk     exposure for health staff as well as for the general population.      Mobile radiography in nursing homes has shown to be technically feasible and the most     beneficial results were that patients avoided unnecessary transport back and forth to the     hospital; in both experiences the majority of patients could be treated locally.      The key points of RADHOME project are two:        1. The first one is to built a network model, with the aim to disseminate clinical use of          domiciliary radiology.        2. The second one is to demonstrate clinical efficiency and cost-effectiveness of          domiciliary radiology.   "
53018|NCT02591589|"     This is a randomized, prospective controlled trial in patients undergoing cardiac surgery,     specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen     and partial pressure of arterial oxygen in the operating room and its impact on a widely-used     and validated neurocognitive score, the telephonic Montreal Cognitive Assessment (t-MoCA),     throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It is     hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the     intraoperative period will have better neurocognitive function than those with maintenance of     hyperoxia.   "
53019|NCT02591576|"     Diabetes is key risk factor for death following acute myocardial infarction. However, the     long-term excess risk of death associated with diabetes following acute myocardial infarction     not known. Investigators aimed to determine the long-term excess risk of death associated     with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI     (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.   "
53020|NCT02591563|"     The purpose of this study is to assess the effectiveness of Prevnar 13 against pneumococcal     acute otitis media.   "
53389|NCT02586753|"     The purpose of this study is to determine which regimen is better for esophageal squamous     carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.   "
53021|NCT02591550|"     The aim of this study is described as follows,        1. To establish a validated method to test cough reflex sensitivity conducted by transient          receptor potential vanilloid 1(TRPV1).        2. To observe the variance of cough reflex sensitivity conducted by transient receptor          potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex          sensitivity conducted by TRPA1 and conducted by TRPV1.        3. To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough          reflex sensitivity.   "
53022|NCT02591537|"     Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the     lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment     arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound     healing will be observed over 14 days.   "
53023|NCT02591524|"     A hot topic in lung transplantation is the treatment of persisting sinus disease/colonization     in CF patients to prevent descending graft colonization and chronic allograft dysfunction.     From 2012, the Hannover transplantation group has been using a conservative approach with     topical nasal inhalation. It is now necessary to analyse the impact of the new approach on     graft colonization, incidence of BOS, symptoms, QoL etc in comparison to a historical cohort.     It is also important to establish which is the best among the different inhaled antibiotic     regimens currently available.   "
53024|NCT02591511|"     The aim of this study is to establish PAtient-Centered Computerized Educating System for     Stroke (PACCESS) for patients with different demands and lack of knowledge.Those in the     intervention group will receive the PACCESS and the control groups will receive traditional     health education to test the effects of PACCESS in increasing clinical decision-making,     health behavior, activities of daily living and knowledge of stroke, and health care quality.   "
53025|NCT02591498|"     The purpose of this study is to investigate the effect of a neuroplasticity-based     computerized cognitive training for people with schizophrenia in the Brazilian population.   "
53026|NCT02591485|"     The purpose of this study is to explore the efficacy of Attention Control Training in     preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near     after a traumatic event and before PTSD is develop.      Individuals who underwent a traumatic event in the past two weeks will be randomly assigned     to either Attention Control Training (ACT), designed to normalize threat-related attention     biases or a control conditions: a psych-education intervention, designed as an active placebo     condition or a follow-up condition, without intervention at all.      Outcome measures will be a diagnosed of PTSD and the level of severity of symptoms derived     from the Clinician Administered PTSD Scale (CAPS-5), after 3 and 6 month since the traumatic     event had occurred.      The investigators expected to find lower ratios of PTSD symptoms in the ACT condition     relative to the control conditions in which no symptomatic relief is expected.   "
53027|NCT02591472|"     Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 million Americans sustain     traumatic orthopedic injuries such as major fractures or amputation each year. Injury is     treated in the hospital by physicians who medically stabilize and reconstruct the patient.     Upon completion of their hospital stay, patients are discharged to begin their reintegration     back into home and community activities. Despite high surgical success and survivorship     rates, these injuries often result in poor quality of life (QOL)-related outcomes in     otherwise healthy people. Fifty to ninety percent of patients develop severe psychological     distress such as post-traumatic stress syndrome, depression or anxiety. Patients are often     not provided the comprehensive support care and resources that are necessary to cope     successfully with psychological stress and reintegrate into purposeful living. This is a     major problem because high distress levels predict poor physical function, use of pain     medications and low QOL. Survivors often cannot return to work, have persistent pain and     experience social isolation. Distress worsens the self-perceptions of functional gain and     efficacy and decreases personal fulfillment. Lingering psychological distress contributes to     the development of other health problems and rebuilding of life is negatively impacted. The     lack of psychosocial support contributes to injury re-occurrence, injury recidivism,     re-hospitalizations and longer hospitalization stays, and higher personal and societal health     care costs.      There is currently a lack of comparative efficacy research to determine which delivery     approach produces greater improvements in the outcomes that are most desired by patients,     specifically, functional QOL and emotional well-being. The proposed research will directly     compare these delivery-of-care approaches and measure the patient-reported outcomes that are     considered important to patients.   "
53029|NCT02591446|"     Autism Spectrum Disorder (ASD) is the most prevalent of the developmental disorders and their     incidence is rising. However, the variability in the behavioral symptoms is large. In part     for these reasons, the ASD clinical diagnosis is challenging and often is not made until 3-5     years of age. Thus, there remains an unmet need for a valid and reliable marker which would     facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and     eventually serve as a useful marker to inform the development of effective therapies and     assess treatment response in future clinical trials. The specific brain based marker that     investigators are currently evaluating is brain plasticity (the changes that occur in your     brain through experience). Investigators measure brain plasticity using noninvasive brain     stimulation including transcranial magnetic stimulation (TMS) combined with brain imaging,     EEG, and behavioral outcome measures. Their work to date demonstrates the potential utility     of these techniques in higher-functioning adolescents and adults with ASD, and pilot data     support the feasibility and safety of applying the same measures to children and lower     functioning individuals.      In this study, investigators will evaluate the validity of this marker in low- and     high-functioning adults with ASD, in low- and high-functioning children with ASD, and assess     the reliability of this marker.   "
53030|NCT02591433|"     This pilot clinical trial studies how well the JeffQuit group therapy program works in     enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group     therapy to provide psychological support and address the mental need for smoking, the habit     or routine it creates, and the physical need for nicotine. It is not yet known how well the     JeffQuit program will work in helping patients with a history of cancer to stop smoking.   "
53031|NCT02591420|"     This study will evaluate the safety and virologic effect of an experimental human monoclonal     antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral     therapy (ART), in adults during early acute HIV infection.   "
53032|NCT02591407|"     The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients     undergoing elective colorectal surgery that have been randomized to transversus abdominis     plane block or epidural anesthesia for the management of perioperative pain in elective     colorectal surgery.   "
53034|NCT02591381|"     The investigators propose a randomized non-blinded comparison of standard vs. transcorporal     approach for placement of an artificial urinary sphincter in male patients with stress     urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the     United States, the artificial urinary sphincter (AUS), manufactured by American Medical     Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in     men. The cuff, which is the portion of the device that encircles and occludes the urethra, is     typically placed directly around the urethra (i.e., standard placement). The cuff can erode     into the urethra. Transcorporal placement has been introduced as a method to reduce the risk     of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies     so as to protect the dorsal aspect of the urethra. This approach has never been compared to     standard placement in a randomized fashion. In the randomized trial, no additional procedures     beyond the normal care protocol will be required of the patients. The investigators will     conduct the study through an established, IRB-approved multi-institutional network of     surgeons. Success will be assessed via objective and subjective methods; complications will     be tallied in a standardized fashion. Outcomes will be measured at two years.   "
53035|NCT02591368|"     This prospective randomized trial aims to ascertain differences in outcome measures for the     operative treatment of basilar thumb arthritis by comparing the two most common surgical     treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both     subjective and objective data to determine if a particular surgical method offers more     favorable outcomes.   "
53036|NCT02591355|"     Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad     applications for a number of medical indications including those in orthopedics, dentistry,     and dermatology. In dermatology, its uses have included treatment of chronic wounds and     facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the     treatment of hair loss, but to the best of our knowledge, there has been only one published     case series documenting its use for this indication.   "
53037|NCT02591342|"     Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with     considerable morbidity and mortality. Recent cohort studies have demonstrated a high     incidence of PPF in elderly patients treated with two commonly used polished, tapered,     collarless stems in elderly patients. The aim of this study was to compare the rate and     characteristics of PPF in a consecutive cohort of patients treated either the polished     tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of     age with femoral neck fracture.   "
53038|NCT02591329|"     The objective of this research is to test the effectiveness of persuasive messages targeted     at parents who have children who consume inadequate amounts of calcium. Specifically, the     effectiveness of the intervention material on increase a) the purchase of calcium-rich     products by parents, and b) the consumption of calcium-rich products in the parent and child     will be examined in 400 families across Canada. Families will receive either the targeted     intervention materials or standard of care generic nutrition materials retrieved from Health     Canada's website. Materials will be delivered to parents during weeks 0, 8, 16, and 22 of the     study. Monitoring of parents' calcium product purchases and consumption behaviour in both     parents and children will occur at week 0,12, 24 weeks (immediately post-intervention) and at     52 weeks (i.e., 6-month follow-up). Purchases will be verified by grocery receipts made     during the aforementioned weeks. Parents will self-report on their dietary consumption as     well as their child's using a food frequency questionnaire. The study hypotheses are as     follows:        1. Parents in the experimental condition will purchase more calcium-rich products as          compared to parents in the control condition.        2. Parents and children in the experimental condition will consume more calcium rich          products as compared to parents and children in the control condition.        3. Perceived outcome expectancies of consuming calcium-rich products will increase to a          greater extent in parents in the experimental condition as compared to parents in the          control condition.        4. Self-regulatory efficacy to consume calcium-rich products will increase to a greater          extent in parents in the experimental condition as compared to parents in the control          condition.        5. Perceived social support and role modelling behaviour will be highest in parents in the          experimental condition as compared to parents in the control condition.        6. Self-regulatory efficacy and outcome expectancies will mediate the changes in          calcium-rich product purchases and consumption.   "
53039|NCT02591316|"     The purpose of this study is to examine the relationship between nutrition, physical activity     and brain function in breast cancer survivors.   "
53088|NCT02590679|"     Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional     Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet     porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the     multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for     percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and     native right ventricular outflow tract (RVOT) after surgical repair of RVOT.   "
53040|NCT02591303|"     Insomnia is characterized by rumination and worry over stressful events affecting nighttime     sleep. Emotional reactions while stressful events are ongoing have not often been     investigated in insomnia. In the current study stress reactions will be measured during a     real-life simulation experiment with stressful events and investigate not only how previous     sleep patterns affect emotional reactivity to the event but also how the emotional events     affect sleep patterns the following night.      Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia     (n=18) will enroll in a interventional study measuring the reaction to and effects of either     neutral or stressful events during driving. Through questionaires and intake polysomnography,     clinical levels of depression and anxiety will be excluded as well as sleep medication use     and alternative sleep disorders than insomnia. Stress levels will be measured through skin     conductance and heart rate variability during events and through nighttime polysomnography     (PSG). Effects on sleep architecture and arousal levels will be measured through nighttime     PSG.      Investigators hypothesize that subjects with insomnia, compared to subjects without sleep     complaints, show stronger emotional reactions to stressful events and stronger effects of     stress on sleep quality the following night. Results will facilitate a model for emotional     reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption     converting into chronic insomnia and aid in developing customized insomnia treatment.   "
53041|NCT02591290|"     The aim of this study is to collect further information regarding an increase immune response     of SP284 after an additional dose in Japanese subjects.      Primary Objective:        -  To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C,          Y and W-135) at 28 days following each vaccination with SP284 vaccine in subjects 20          through 55 years of age.      Other Pre-specified objective:        -  To describe the safety in terms of immediate systemic adverse events, solicited          reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs)          following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.   "
53042|NCT02591277|"     This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)     fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients     with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine     clinical use, the primary objective of this study is to evaluate the incidence of adverse     drug reactions (ADRs) under real world settings.   "
53043|NCT02591264|"     The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the     occurrence of periprocedural myocardial infarction.   "
64876|NCT02436499|"     Pilot study evaluating effect of Botox injection treatment for 12 individuals suffering from     chronic migraine on function MRI imaging, before and after treatment.   "
53044|NCT02591251|"     Laparoscopy is a minimally invasive method used for diagnostic and therapeutic purposes. It     allows surgeons to take a look on the abdominal and pelvic organs. Diagnostic laparoscopy is     usually done in an operating room under general anesthesia. The procedure takes about 25     minutes and the patients usually discharged in the same day. The laparoscopy can diagnose     pelvic pathological conditions in approximately 50% of the cases. However, the laparoscopy     has some complications, such as infections, hemorrhage and injuries of visceral organs.      A preoperative vaginal preparation is important to prevent the bacteria colonization in a     trial to avoid postoperative infection after laparoscopic surgery. The povidone-iodine (PI)     is normally used as a skin and vaginal disinfectant to prevent postoperative infections,     however; it can be the cause of significant postoperative irritation.      There are many reports in the literature proved that the mechanical cleansing of the vagina,     not the use of an antiseptic solution, is responsible for the efficacy of vaginal     preparations. In the field of assisted reproductive technology; A study in 1992 concluded     that the infection rates with normal saline solution are comparable to PI.      Another proved that, a normal saline solution can be effective in prevention of preventing     postoperative infections after vaginal surgery.      The most recent study by Lewis et al has been shown that the Baby shampoo is preferable than     PI in vaginal cleansing before gynecologic procedures because it has minimal vaginal     irritation and cheaper than PI.      So the optimal vaginal antiseptic solution is unknown, the investigators want to conduct a     randomized trial comparing 2 commonly used vaginal antiseptic solutions: PI and the saline     solution before the laparoscopic surgery.      The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning     wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike     many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.   "
53045|NCT02591238|"     The main purpose of this study was to evaluate the effects of melatonin in the regulation of     the vascular injury in smokers through population-based, randomized, double-blind,     placebo-controlled trial.   "
53046|NCT02591225|"     This is a single-center, randomized, two treatment groups, open, phase IV clinical study in     subjects with atrial fibrillation and left atrial thrombus. At Visit 0 (Screening Visit)     subjects with left atrial thrombus established in transesophageal echocardiography (TEE) are     eligible to entry in the study. If the subjects fulfill all other in- and exclusion criteria     and undersign the informed consent the baseline cranial magnet resonance imaging (MRI) can be     performed followed by randomization to one of the two treatment groups (Phenprocoumon or     Dabigatran) at Visit 1 (Baseline Visit). The subjects will be treated for 12 months with     Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinely clinical     follow up visits will be done at week 4, month 3, month 6, month 9 and month 12. Follow up     TEE will be performed after 4 weeks and after 12 months also the follow up cranial MRI at     this visit. If the subject was randomized in the VKA group routinely INR measurements will     performed.   "
53047|NCT02591212|"     The purpose of this randomized intervention pilot is to evaluate the relative efficacy of     bystander training elements (delivery mode and integration of substance abuse prevention)     among cohorts of incoming undergraduates at the University of Kentucky, a nationally     recognized leader in addressing sexual violence through bystander intervention programming.     Per university policy, all incoming undergraduates will participate in mandatory online     training covering sexual violence awareness, bystander concepts, and alcohol use/abuse.     Consenting students will be randomized to one of the following training conditions:        1. Green Dot Intensive Bystander Training (INT) or        2. Student Wellness Training (active control). Students in each condition will be followed          for 9 months, one academic year.   "
53048|NCT02591199|"     The purpose of this study is to determine if the combination product (URG101) is safe and     effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for     the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and     double-blinded such that neither the subject nor doctor will know which drug or placebo is     received.   "
53257|NCT02588482|"     The purpose of this study is to measure whether high-density electroencephalography can     improve the detection of electrophysiological signs of awareness compared to conventional     electroencephalography in post-anoxic comatose patients   "
53049|NCT02591186|"     Experimental Approach: (1) Participants: Women (ages 21 to 42) who seek IVF treatment at the     Center for Fertility & Reproductive Surgery will be eligible for the study. Seventy women     will be recruited and randomly assigned to either the intervention (acupuncture plus standard     care) or the comparison (standard care alone) group. (2) Intervention: Participants in the     intervention group will receive 3 acupuncture sessions during the project with the first     treatment between day 6-8 of the stimulated IVF cycle, second on the day of embryo transfer     and the third one day post transfer. Participants in the comparison group will receive no     intervention but will receive standard care. (3) Measures: The primary outcome measures     include prostacyclin and thromboxane vasoactive biomarkers. Secondary outcome measures     include perceived stress levels. (4) Procedure: Upon IRB approval, an informed consent will     be provided to all participants. Pre- and post- acupuncture urinary metabolites of     prostacyclin and thromboxane will be assessed. A standardized Perceived Stress Scale will be     administered before and after each acupuncture session for the study group, and before and     after a 30-40-minute waiting period for the control group.   "
53050|NCT02591173|"     Pharmacologic approaches to increase levels or actions of the vasodilatory peptide     angiotensin-(1-7) are currently in development for the treatment of hypertension based on     findings from animal models. There are limited and contradictory clinical studies, however,     and it is not clear if this peptide regulates blood pressure in humans. The purpose of this     study is to better understand the cardiovascular effects angiotensin-(1-7) in human     hypertension, and to examine interactions of this peptide with the autonomic nervous system.     The investigators propose that the difficulties in showing angiotensin-(1-7) cardiovascular     effects in previous clinical studies relates to the buffering capacity of the baroreceptor     reflex to prevent changes in blood pressure. Autonomic failure provides the ideal patient     population to test this hypothesis. These patients have loss of baroreflex buffering and have     low levels of angiotensin-(1-7) in blood. The investigators will test if angiotensin-(1-7)     infusion can lower blood pressure in patients with autonomic failure, and will determine the     hemodynamic and hormonal mechanisms involved in this effect.   "
53051|NCT02591160|"     Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia in the     ambulatory setting. PHPT may be cured with surgery and indications for intervention have been     defined and include urinary calcium/creatinine clearance. Hydrochlorothiazide (HCTZ), the     most commonly prescribed medication for hypertension, reduces urinary calcium excretion and     confounds urinary testing. As a result, it is universally recommended that thiazide diuretics     be stopped in advance of urinary testing. To date, no studies are available to provide     evidence-based guidance as to how long HCTZ must be held for urinary calcium excretion to     return to steady state in PHPT. The objective of this study is to serially calculate urinary     calcium/creatinine clearance ration in patients with suspected PHPT while holding HCTZ to     determine the minimum duration of medication cessation necessary for urinary calcium     clearance to reach steady state.   "
64877|NCT02436486|"     To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy     men.   "
53052|NCT02591147|"     This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel     arms: an intervention group using silver diamine fluoride (SDF) and a placebo group     (control). 144 eligible healthy adults will be enrolled in the study and randomly assigned to     one of the two treatment groups. Both groups will receive the traditional preventive measures     including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will     be followed for two years and caries progression will be radiographically monitored.   "
53053|NCT02591134|"     The effects of non-nutritive sweetened (NNS) beverages on weight management and psychological     indices of appetitive behaviour have not been assessed in both weight loss and maintained     weight loss phases over the long term to determine whether NNS beverages may assist in     efforts to lose weight and maintain weight loss and how this affects appetite expression     (satiety, food choice, craving, ease of dieting etc.). Thus the present research will     determine the impact of NNS beverages as compared to water on weight loss and weight loss     maintenance, satiation, satiety, cravings for sweet, exercise efforts and mood state across     both a period of weight-loss as well as a weight-maintenance phase. To determine if the     effects of NNS on appetite are beneficial or detrimental to successful weight management, the     study will also systematically compare the effects of NNS beverages, water and caloric     beverages (CBs) on appetite (hunger, satiety, liking and wanting) and energy intake     (including food choice and caloric compensation) across the whole day during active weight     management in a subset of participants.   "
53054|NCT02591121|"     Prospective, single-centre study in healthy volunteers to establish a reference range for the     RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the     reference range for measurement of PCT levels using the RAMP Procalcitonin test.   "
53055|NCT02591108|"     The assessment of neuromuscular blockage is common practice in the operating room, in which     such agents are employed. Still today, the use of simple hand held stimulators and visual     monitoring of these responses are the norm. The investigators want to study the potential for     employing a non‐invasive quantitative device with built in sensors that will hopefully     accurately determine the degree of neuromuscular blockade. This system utilizes commonly     employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and     an automated detection system. This system will not only utilized pre‐blockade, but also     throughout an entire surgical procedure and during reversal therapy. For comparisons, the     investigators will use both the prototype device and a standard hand held TOF for the     assessment of neuromuscular blockage. In other words, the planned protocol will involve     testing the effectiveness and accuracy of the device concurrently with peripheral nerve     stimulation, during a procedure as is done for the current standard of care. All protocols     will be carried out under the direct guidance and supervision of anesthesiologists and/or     nurse anesthetists.   "
53056|NCT02591095|"     ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.   "
53057|NCT02591082|"     This is an observational study to assess patient survival and clinical outcomes after the     RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.   "
53315|NCT02587728|"     Carpal tunnel is an early manifestation of amyloidosis in a significant minority of patients.     This specimen collection protocol will allow the investigators to screen patients with carpal     tunnel syndrome for amyloidosis.   "
53058|NCT02591069|"     Minimally Conscious (MCS) or Vegetative State (VS) are disorders of consciousness which often     occur following traumatic brain injury or ischemia. These alterations result most of the time     in patients' loss of autonomy and require long years of special care. No efficient therapy to     improve patients' consciousness has been found so far. Investigators propose to use vagal     nerve stimulation (VNS) to restore cortical activity and patients' embodied self. The     investigators' main hypothesis is that VNS will reestablish the thalamo-cortical connectivity     leading to an improvement of the consciousness state. To test this hypothesis, investigators     will use behavioral measures as well as fMRI, PET scan and EEG to assess brain activity.     Patients will be evaluated before and during eight months following implantation of the     stimulation device.   "
53059|NCT02591056|"     The purpose of this study is to determine whether low level laser light therapy applied using     the Erchonia Verju Laser combined with manual lymph drainage applied using the Iskra Medical     Green PRESS 8 Lymph Drainage System is effective in reducing the circumference of the waist,     hips and upper abdomen.   "
53060|NCT02591043|"     Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical     stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a     structured follow up examination or evaluation of outcome after surgery.   "
53061|NCT02591030|"     Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their     therapeutic management is complex and must be multidisciplinary in nature. Most of the time,     an endoscopic or radiological biliary drainage is necessary before any tumour treatment.      Their prognosis is poor due to the fact that they are normally diagnosed late, which makes     curative surgery impossible. A population study in the Côte d'Or region of France reported a     survival rate at 5 years of approximately 10%.      For the locally advanced or metastatic forms, treatment has not been properly codified. With     respect to chemotherapy, prospective studies, most often phase II, are difficult to interpret     due to a limited number of patients and due to the heterogeneity of this type of tumour (bile     duct and pancreas tumours). Treatment with 5FU alone provides an objective response in     approximately 10% of cases. In combination with mitomycin or carboplatin, the objective     response rate is 20%, with a median survival period of 5 months. Interferon combined with 5FU     has a better response rate (30%), but occurrences of different types of toxicity are more     frequent.      More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour     control in 50% of patients with a median survival period of 10 months. Gemcitabine combined     with oxiplatin or with cisplatin has shown the same response rate but a median survival     period of approximately 12 months.      The benefit of this combination has been confirmed in a phase III trial that compared the     gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally advanced     unresectable and/or metastatic bile duct cancer. The results were in favour of the combined     treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64 [0.52 -     0.80]). This combination is currently the reference first-line treatment.   "
53062|NCT02591017|"     34 adult (>18 years) cancer pain outpatients with Opioid base therapy because of pain and     breakthrough pain or extreme pain on movement will be included in this prospective,     randomized, double-blind crossover study.      Over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one     week: Group A receives morphine drops and Placebo spray, Group B receives ketamine/chitosan     spray nasal and Placebo drops and Group C receives morphine drops and ketamine/chitosan spray     nasal.      Primary endpoint is time to onset of action of intranasal ketamine compared with morphine     drops. Secondary endpoint is the median numeric rating scale (NRS) improvement after using     the spray or morphine or the combination of ketamine spray and morphine drops.   "
65740|NCT02425202|"     The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side     effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.   "
53063|NCT02591004|"     The aim of this study is to investigate the possible use of calcium channel as a     neuroprotectant in cases with PTL. This will be done by comparing the effect they have on     cerebral blood vessels with the already established MgSo4. They have been proven superior to     magnesium sulphate in tocolysis, and they possess the mechanism of action that would allow     for their theoretical use as neuroprotective agents.   "
53064|NCT02590991|"     This study investigate the long term effect of supplementation of pre- and probiotics in     early life in children born by Caesarean Section.   "
53065|NCT02590978|"     Randomized controlled trial to demonstrate the safety of early cholecystectomy (<72h) in     patients with mild gallstone pancreatitis. The purpose of this study is to demonstrate that     there is a shorter hospital stay and no higher complication rates.   "
53066|NCT02590965|"     This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial     to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients     with advanced non-squamous non-small cell lung cancer who failed to second-line standard     chemotherapy.   "
53067|NCT02590952|"     Epitinib (HMPL-813) is a selective EGFR tyrosine kinase inhibitor. Epitinib has demonstrated     strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR     mutations in pre-clinical setting. This first-in-human study is conducted to assess the     maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability,     pharmacokinetics (PK), and preliminary anti-tumor activity of Epitinib.   "
53068|NCT02590939|"     The main objective of this study is to assess the efficacy of the Cefaly® device as an acute     treatment of migraine attack in adult patients. The patients will be applied either an active     or placebo external neurostimulation for 1 hour during a migraine attack, and will report the     pain on a visual analog scale before and after the treatment.   "
53069|NCT02590926|"     Fractional Flow Reserve (FFR) has recently emerged and has been largely validated as a safe     and efficacious way of ischemia testing for patients with stable angina. The new recently ESC     guidelines have strongly suggested a FFR based approach for patients with stable angina, also     for those with challenging lesions like left main disease, severe multivessel stenosis for     heart failure patients and those with single remaining vessels although left main disease and     an ejection fraction less than 30% are exclusion criteria of the randomized controlled trials     on this topic. Consequently the investigators performed a prospective multicenter study to     understand the safety and efficacy of a FFR based approach for these patients.   "
53070|NCT02590913|"     The purpose of this study is to investigate the metabolic and endocrine responses during 3     hour after taking 75g fructose or glucose in young Chinese.   "
53258|NCT02588469|"     The purpose of this study is to assess the effects of physical exercise, associated or not     with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper     airway resistance in obese teenagers. Half of the participants will undergo physical exercise     and compression socks program, and the other half of subjects will undergo physical exercise     program without compression socks.   "
53071|NCT02590900|"     Compared to early postpartum (10-15 weeks) observations, paracetamol clearance was     significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. This higher clearance was due     to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a     proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal     clearance (1.15 vs 0.75 l.h-1, 53 %) [KUlo et al, Int J Obstet Anesth]. This increase in     glucuronidation clearance may in part be driven by oestradiol, and may explain within and     between individual differences in paracetamol metabolism (e.g. oral contraceptives,     follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women.      Based on a pooled analysis, investigators aimed to further explore the impact of these     covariates on paracetamol metabolism based on plasma and urine collections in women at     delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral     contraceptives (OC) following intravenous (iv) paracetamol administration.   "
53072|NCT02590887|"     The purpose of this study is to determine the health effects of the 4 weeks intake of a drink     manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood markers     of inflammation, oxidative stress, carbohydrate, lipid, protein and liver metabolism,     together with general hematology and blood coagulation will be assessed at baseline time (day     0) and after (day +14, +28 and +42) drink ingestion.   "
53073|NCT02590874|"     The purpose of this study is to determine whether Cymbalta (duloxetine) is effective to     improve cognition in individuals with Mild Cognitive Impairment.   "
53074|NCT02590861|"     Distal extension Partial Removable Dental Prostheses (PRDPs) are less stable than tooth     supported PRDPs due to progressive resorption of the alveolar ridge, which alters the     retention and support generated by alveolar bone height. In addition, long-term wearers     suffer with progressive alveolar ridge resorption that contributes to greater instability.     The loss of stability and retention under the PRDP can lead to difficulties during     mastication and swallowing, because of movement of the partial denture. These difficulties     force patients to self-select food substances that are softer and easier to chew and possibly     create changes in social eating. Therefore, having a partial denture that is poorly retentive     will impact their oral health related quality of life Oral Health Related Quality of Life     (OHRQoL). The placement of a dental implant into the edentulous area will transform a     conventional PRDP into an Implant Supported PRDP, which will improve the functional capacity     of partial denture wearers, especially their ability to comminute harder food substances such     as fruits and nuts. The purpose of this study is to quantitatively measure the functional     differences of patients wearing conventional PRDP with patients wearing implant supported     PRDPs and Oral Health Impact of patients wearing implant supported PRDPs. The hypothesis is     that patient wearing implant supported PRDPs will have greater functional capacity than     patients wearing conventional PRDPs.   "
53085|NCT02590718|"     The study is carried out in a prospectively randomly controlled way. In the context of     acknowledgement and understanding from parents, by comparing with traditional process (lying     without the pillow and fasting water and food for four hours following lumbar puncture), an     optimized postoperative management (lying without the pillow for half an hour following     lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face,     legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after     lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire     about bad memory during lumbar puncture for all parents and children will be investigated in     order to establish an optimized lumbar puncture management process.   "
54658|NCT02570191|"     This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants     with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the     target sample size is 60 individuals.   "
53075|NCT02590848|"     Background: Adolescence is an important period for brain development as a result of increased     synaptic plasticity. Omega-3 polyunsaturated fatty acids (n-3 PUFAs) are essential nutrients     for brain development and protection against oxidative stress. Walnuts have the highest n-3     PUFA concentrations of all edible plants.      Objective: The investigators hypothesize that walnut intake will increase n-3 PUFA     availability in the body to a level that enhances the development of the brain during     adolescence. The technicians will conduct a long-term (6 months) population-based randomized     controlled trial in teenagers (n=400), and determine the effectiveness of the intervention     (30 g of walnut kernels per day, ~1.5g of n-3 PUFA) in enhancing brain development.      Methods: Fieldwork team will contact teenagers and families in collaboration with 20 high     schools. Families will receive a basic guide on following a healthy diet in order to ensure     implementation and adherence. Brain development outcomes will be measured at baseline and     after the intervention. The use of computerized neuropsychological tests will provide the     precision required to detect even subtle changes in brain development resulting from the     nutritional intervention. Behavioral (socio-emotional) development will be assessed in order     to cover a wider picture of brain development. Blood samples will be collected to measure n-3     PUFA levels before and after the intervention in a randomized subsample from both groups     (control/ intervention). Linear regression models adjusted for baseline neuropsychological     scores will be used to analyze the intervention effect.      Implications: The outcomes of this Project are expected to be a greater understanding of the     role of n-3 PUFA intake (walnut) in brain development. A major goal in public health research     is to develop cost-effective health recommendations to teenagers.   "
53076|NCT02590835|"     This study was designed as a randomized controlled clinical trial to compare conventional     orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS     group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege     University Hospital, Belgium who met the inclusion criteria were enrolled from January to     October of 2013.   "
53089|NCT02590666|"     Hysteroscopy today is considered the gold standard for the diagnosis and treatment of     endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently     available. Among Others bipolar systems and microscissors or graspers, both of theme make     part of routine clinical practice and are universally accepted.      The aim of the study is to compare the efficacy of bipolar resection energy polypectomy     versus microscissors or graspers These procedures assume a lower cost and are associated with     a lower surgical risk due to their realization without anesthesia .      Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of     the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique     with a high percentage of resection and high degree of satisfaction of patients   "
53259|NCT02588456|"     This is a single center, single arm, open-label pilot study to determine the feasibility and     safety of a single dose of autologous T cells expressing CD22 chimeric antigen receptors     expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART22     cells) administered in split fractions, in adult patients with relapsed or refractory B-cell     acute lymphoblastic leukemia.   "
53077|NCT02590822|"     There is an epidemic of type 2 diabetes in younger adults. These patients are at very high     lifetime risk of heart-related complications. Subtle heart abnormalities can be present even     at a young age in these patients and may predispose them to heart failure and ultimately     premature death. There is emerging evidence that type 2 diabetes can be reversed with weight     loss. We propose that weight loss can also reverse the fatty changes seen in the liver and     heart in these patients, and in turn lead to improved heart function.      This project aims to identify how type 2 diabetes causes changes in the heart in young people     with type 2 diabetes by performing detailed scans and other tests of the heart's structure     and function. In addition we will attempt to see if the heart's pumping function can be     improved, either by a weight loss program with a special low calorie diet, or by a structured     program of exercise. This will be compared with the usual standard diabetes care.      As well as looking to see if the heart's function can be improved with the intervention, we     also aim to identify what the mechanism of any improvement would be. We suspect that changes     in the amount of fat within the liver and the heart may be responsible, and will measure     these at the beginning, end and in some patients halfway through the study to explore     possible mechanisms amongst other clinical variables (e.g. HbA1c)   "
53078|NCT02590809|"     Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized     by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is     observed within the left ventricle which is named left ventricular outflow tract obstruction     (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms     such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To     now, medical or interventional treatments such as betablocacker, calcium blockers or septal     alcoholisation or surgery present with a limited efficiency. Recent studies from     investigators group revealed new concepts about the role of venous return to the LVOTO.     Therefore the investigators hypothesis that BX1514M generating a venous vascular     constriction, could improve symptoms of HCM patients by reducing LVOTO.   "
53079|NCT02590796|"     The study has two phases: Phase B and Phase C. The purpose of the Phase B study is to     determine the performance (sensitivity and specificity) of a smartphone application (DelApp)     to identify delirium in the whole inpatient sample. The study also aims to determine the     performance (sensitivity and specificity) of the DelApp to discriminate between delirium     (with or without dementia) and dementia (without delirium).      The purpose of the Phase C study is to determine the efficacy of the DelApp software     application in detecting delirium in unselected patients in an inpatient sample and to     determine the performance of the DelApp to discriminate between delirium and dementia. The     study also aims to explore the performance of the DelApp in tracking change in cognitive     function.   "
53080|NCT02590783|"     Pelvic ring fractures in the elderly are associated with high morbidity during standard     conservative treatment due to immobility. Furthermore the risk of long term dependence even     after the fracture has united is high. In analogy to the treatment of hip fractures in a     similar patient population, patients might benefit from surgical treatment due to a reduction     in pain and early mobilization.   "
53081|NCT02590770|"     The purpose of this study is to determine whether giving gaze-contingent feedback is an     effective attention modification procedure, helping in the treatment of social anxiety     disorder (SAD)   "
53082|NCT02590757|"     This study is a randomized controlled study to compare if a a non-invasive neurally adjusted     ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure     (N-CPAP) after extubation in infants' < 30 weeks of gestation.   "
53083|NCT02590744|"     This study is a single-center, prospective, randomized, controlled trial. To investigate if     preoperative using of eye patch will decrease emergence agitation, and to provide a better     method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.   "
53084|NCT02590731|"     Introduction: Femoral neck fracture is a devastating injury with serious medical and social     consequences. One third of these patients have some degree of impaired cognitive status.     Despite of this, a high proportion of hip fracture trials exclude patients with cognitive     impairment. The investigators aimed to evaluate whether moderate to severe cognitive     impairment could predict walking ability, quality of life, functional outcome, reoperations     and mortality in elderly patients treated with hemiarthroplasty.      Methods: This cohort study included a consecutive series of 188 patients treated with     hemiarthroplasty for an displaced femoral neck fracture. Patient were assessed for estimated     preoperative and 1 year postoperatively with regard to walking abilities, cognitive status,     quality of life with EQ-5D and hip function with Harris hip score.   "
53144|NCT02589951|"     The purpose of this study is to determine the prevalence, etiology, and timing of missed     Serious Medical Illness (SMI) in patients referred to adult psychiatry by emergency     physicians, as well as to determine admission rates for SMI soon after discharge from an     inpatient psychiatry admission.   "
53086|NCT02590705|"     The study is carried out in a prospectively randomly controlled way. In the context of     acknowledgement and understanding from parents, by comparing with traditional process(no     anesthesia), lidocaine surface anesthesia is randomly selected. All children will be     evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale     to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the     lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar     puncture for all parents and children will be investigated in order to establish an optimized     lumbar puncture management process.   "
53087|NCT02590692|"     The Phase I/IIa clinical trial is designed to assess the feasibility of delivery and safety     of Human Embryonic Stem Cell-Derived RPE Cells on a parylene membrane (CPCB-RPE1) in patients     with advanced, dry age-related macular degeneration.      Primary Objective:      • To test the safety and tolerability of CPCB-RPE1 during and after subretinal implantation     in patients with geographic atrophy with evidence of involvement of the central fovea.      Secondary Objective:      • To assess visual acuity, visual field, and retinal function after CPCB-RPE1 implantation.     Implanted and fellow eyes will be compared post-implantation to assess the ability of the     implant to prevent disease progression.      Exploratory Objectives:      • To assess the feasibility of measuring the change in area of geographic atrophy over time     using spectral domain optical coherence tomography or fundus autofluorescence.   "
53090|NCT02590653|"     The primary goal      • To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the     disease on the parameters of global and regional myocardial deformation in the infarcted area     and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks     of treatment;      The secondary goals. To evaluate the effect of treatment:        -  on the parameters of the global and regional myocardial deformation in the intact area          on day 7, on 12, 24, 36 and 48 weeks of treatment;        -  on the parameters of the global and regional myocardial deformation depending on the          degree of coronary blood flow restoration by thrombolysis in myocardial infarction          (TIMI)        -  on systolic and diastolic left ventricular function in the presence of initial          impairments, or absence of the negative dynamics of these parameters in case of normal          baseline values;        -  on the clinical diagnostic criteria for the development or progression of heart failure;        -  the dynamics of the duration and extent of myocardial ischemia according to the daily          ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;        -  the appearance of new prognostically significant cardiac arrhythmias        -  on the pulse wave velocity        -  the thickness of the intima-media complex (IMT); 200 patients are planned to be include          in a randomized, single-center, open, prospective, controlled clinical trial, the          enrollment will be held at the Department of Therapy of Medical Institute of Penza          State University.      Definition of the study group:      The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in     the study        -  Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;        -  Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned          number of patients: Pre-Screening - 300 subjects; screening and randomization - 200          subjects.      Patients will be randomized by random number generation to include in the group 1 or 2. All     included patients will be on the standard basis therapy of the coronary artery disease,     according to the national recommendation.   "
53091|NCT02590640|"     The goal of this study is to determine if a specific experimental brain stimulation technique     can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study     plans to learn more about the way an experimental technique called transcranial magnetic     stimulation (TMS) affects a specific part of the brain, called the insula. Some research     suggests that this part of the brain plays an important role in craving. The investigators     plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI)     of subjects' brain.      For interested participants, this study requires a single 3 hour appointment, which will     include MRI of the brain as well as TMS.   "
53092|NCT02590627|"     Drug efficacy testing is one of the most important tasks that is routinely undertaken by the     National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World     health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT)     and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently,     Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and     Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine     (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is     revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as     an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ     is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess     the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the     NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment     guidelines as the second line drug for the treatment of uncomplicated malaria in the country.   "
53093|NCT02590614|"     Determine differences in serum vitamin D metabolism by genetic ancestry.   "
53094|NCT02590601|"     Peripartum cardiomyopathy (PPCM) is a rare, but significant heart disease affecting young     women in the puerperal period. Thus far, no specific treatment has been approved to treat     this disease. PPCM has a wide spectrum of clinical manifestations ranging from mild heart     failure to severe cardiomyopathy, cardiogenic shock and death. A significant proportion of     survivors have persistent chronic heart failure leading to disabling symptoms and decreased     quality of life.      Animal studies have suggested that prolactin is central to the development of PPCM. Prolactin     has pro-inflammatory and anti-angiogenic effects that may promote PPCM. Bromocriptine, a     central dopamine agonist known to decrease prolactin levels, might thwart its deleterious     effects in women suffering from PPCM. Following this rationale, bromocriptine should improve     myocardial function in women suffering from PPCM and thus, improve cardiovascular outcomes     and healthcare outcomes.   "
53095|NCT02590588|"     The investigators expect to enroll 15 participants with relapsed or refractory IgM-associated     AL amyloidosis onto this Phase II clinical trial. Idelalisib will be self-administered orally     at a dose of 100 mg twice daily (may be increased to 150 mg (one tablet) twice daily after 3     months at investigator discretion). Participants will be treated until disease progression,     unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be     performed every three months until disease progression.   "
53096|NCT02590575|"     The purpose of this study is to test the effectiveness of a membrane gas exchange device in     the venovenous circulation of a continuous renal replacement therapy for the purpose of CO2     elimination and pH compensation. Thus, the primary endpoint is the modification of the PaCO2     and/or the ventilator settings (tidal volume VT and plateau pressure Pplat).   "
53097|NCT02590562|"     This observational study will describe the treatment patterns of usage of biological DMARDs     in routine clinical practice and the demographics and RA disease characteristics in patients     suffering from rheumatoid arthritis. Patients will be recruited and examined the same day     when recruited. There will be no follow up visit or treatment period only one visit in this     study.   "
53098|NCT02590549|"     A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert     Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus     safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. in     2003, has become a standard treatment for progressive keratoconus to slow or possibly stop     progression of disease.      The formation of the stromal pocket during MyoRing implantation offers the opportunity for     simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to     provide combined treatment in patients with progressive keratoconus.   "
53099|NCT02590536|"     This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler     velocity indices of the umbilical arteries in patients with placental insufficiency and fetal     growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those     patients.   "
53100|NCT02590523|"     The goal of this study is to determine the safety (but not efficacy in preventing infection)     of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin     at certain dosages and concentrations as prepared by a compounding pharmacy when used     intracamerally at the time of cataract surgery.   "
53101|NCT02590510|"     The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in     the treatment of meningeal carcinomatosis.   "
53102|NCT02590497|"     This pilot clinical trial studies the correlation between the genetics and brain images of     patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a     tumor are an important way to predict how well it will respond to treatment. Imaging, using     magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may     also provide information that helps doctors predict how brain tumors will respond to     treatment. If MRI can provide doctors with similar information about the tumor as the tumor's     genes, it may be able to be used to predict tumor response in patients whose tumors cannot be     reached by surgery or biopsy to get tissue samples.   "
53103|NCT02590484|"     Placenta previa and placenta accrete carry significant maternal and fetal morbidity and     mortality. Several techniques have been described in the literature for controlling massive     bleeding associated with placenta previa cesarean sections. The aim of this study is to     evaluate the efficacy and safety of the use of the cervix as a natural tamponade in     controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.   "
53104|NCT02590471|"     Comparison of two methods for revascularization of the superficial femoral artery: stenting     of the superficial femoral artery vs. stenting of the superficial femoral artery supplemented     with fasciotomy in Hunter canal in patients with steno-occlusive lesion of the     femoro-popliteal segment of TASC C, D.   "
53105|NCT02590458|"     The goal of this clinical research study is to test if a short breast MRI scan (about 10     minutes) can be used for breast cancer screening in high risk people and to learn if it is as     effective as a routine breast MRI scan (30-60 minutes).   "
53106|NCT02590445|"     Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain     stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most     effective treatment for refractory OCD. However, the affecting area of traditional electrodes     is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental     contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the     other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in     ventral capsule simultaneously, which the investigators believe will be more effective due to     better compatibly with anatomical features of target area. This trial is to evaluate the     effectiveness and safety of this approach.   "
53107|NCT02590432|"     The primary objective of this study is to assess the potential of linaclotide treatment to     induce the development of anti-drug antibodies (ADAs). The secondary objectives are to     provide additional evidence supporting the long-term safety and efficacy of linaclotide in     adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation     (CIC) patients and to evaluate lower doses of linaclotide.   "
53108|NCT02590419|"     Using Synaptive Medical's BrightMatter™ products to better visualize and plan epilepsy     surgeries by considering white matter tracts, and considering whether the technology results     in improved clinical outcomes.   "
53109|NCT02590406|"     The risk of complication associated with airway in obese patient is important. The result of     pre-oxygenation gives the clinician a prolonged non-hypoxic apnea time. The relation between     FRC and non-hypoxic apnea time has been correlated. However, the best condition to accomplish     the pre-oxygenation in morbidly obese patient has yet to be described in the medical     literature. A study previously done in our hospital (EPO2-PV) compared the effect of     different positions and ventilation modes on the FRC in the laboratory. A significant     difference has been established on the FRC between the inverse Trendelenburg position with     positive pressure ventilation and the head up (beach-chair) position without positive     pressure. The current study, EPO2-A is designed to compared the two positions and ventilation     modes during the induction of general anesthesia on morbidly obese and correlate the     difference in FRC to difference in apnea time.   "
53110|NCT02590393|"     The purpose of this study is to learn more about the nicotine and non-nicotine chemicals that     are part of e-cigarettes and their effects on cigarette smokers by assessing smokers'     experiences with different e-cigarettes using a battery of self-report, biochemical, and     behavioral indices. This is not a smoking cessation study; smokers will not be asked to quit     smoking, and e-cigarettes will not be used as a medical device or therapy.   "
53111|NCT02590380|"     Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and     sagittal correction of the adolescent idiopathic spine deformity in comparison to the side     loading DePuy Synthes USS II pedicle screw system.   "
53112|NCT02590367|"     The purpose of this study is to estimate the usefulness and safety of HD6610 granule for     oxaliplatin-induced peripheral neuropathy. The investigators examined the efficacy and safety     of the treatment algorithm for 64 patients with colorectal cancer by evaluating the side     effects and degree of improvement of subjective symptoms.   "
53113|NCT02590354|"     HIV-1 infected patients with normal peripheral blood CD4+ T-cell counts and undetectable     viral load will be recruited in four Belgian HIV reference centers. Selected patients will     undergo a two-step screening in which a viral reservoir measurement will be performed and     among those with a very low viral reservoir an analytical treatment interruption of their     longstanding antiretroviral therapy (ART). There is no randomization foreseen. Patients will     receive an intense clinical and laboratory follow-up during 48 weeks followed by 12 weeks     post intervention.   "
53114|NCT02590341|"     MYKKE is a prospective multi-center registry for children and adolescents with myocarditis.     The aim is to generate prospective multi-center data on epidemiology, diagnostics, and     therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic     and therapeutic approaches for this myocardial disease.   "
53115|NCT02590328|"     The goal of the proposed research is to observe the prevalence and establish the validity of     a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used     is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs)     that is absent in SCID patients, thus correlating with the disease.   "
53150|NCT02589873|"     This study evaluates two group-based Diabetes Prevention Program (DPP) lifestyle     interventions delivered in the workplace to individuals at risk for pre-diabetes: 1) an     in-person group-based lifestyle intervention; and 2) an internet-based intervention delivered     using an online platform with lifestyle coaching support. Eligible participants will be     randomized equally to each intervention program (120 participants in each).   "
53116|NCT02590315|"     Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis     (DBT) is more sensitive and more specific than conventional digital mammography (DM).     However, large randomised controlled trials (RCTs) are needed to confirm these promising     results. Furthermore, potential side effects of DBT in the screening setting have to be     properly evaluated. In particular, the major concern is about overdiagnosis and its     consequences; overdiagnosis refers to the detection of cancers at screening, which would not     have become clinically apparent in the woman's lifetime.      This RCT was designed to compare benefits and harms of DBT in a population-based screening     program with conventional DM. The primary outcome parameter will be the difference between     the two tests in rates of advanced cancers detected at the subsequent round and interval     cancers (within the first two years after the study screening round). Secondary outcomes     measures will be diagnostic performance indicators for organised breast screening (i.e,     cancer detection rate, recall rate, false positive rate, positive predictive value),     parameters used in cost-effectiveness analysis, pathologic and biological characteristics of     screen-detected cancers.   "
53117|NCT02590302|"     The overarching goal of this project is to improve timely access to appropriate mental health     (MH) care for children and youth. The investigators will conduct and rigorously evaluate     implementations of this pathway in four exemplar hospitals and associated CMHA dyads within a     local health region. Outcomes-based validation of this pathway is important for effective     adoption in other communities. A multiple baseline study design and conduct interrupted     time-series analysis will be used to evaluate whether the EDMHCP has resulted in improved     health care utilization, medical management, and health sector coordination. To ensure EDMHCP     feasibility in various settings, implementation will occur in four exemplar     hospital-community dyads with different workflows and patient populations.   "
53118|NCT02590289|"     To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of     BBI-5000 capsules in healthy adult subjects.   "
53119|NCT02590276|"     The project focuses on C9orf72, the most frequent genetic form of frontotemporal dementias     (FTD, or frontotemporal lobar degeneration, FTLD) and amyotrophic lateral sclerosis (ALS).     FTD is the second commonest cause of degenerative dementia in presenium after Alzheimer's     disease. Behavioural and cognitive impairments progressively lead to dementia. ALS produces     progressive muscle weakness leading to the death in 2 to 4 years. Since 2006, major     discoveries have linked FTLD and ALS:        1. TDP-43 aggregates in neurons and        2. C9orf72 mutations is a major genetic cause in both disorders.      Two major pathological subtypes are now defined in FTD, FTD-TDP and FTD-TAU. C9orf72     mutations (associated to FTD-TDP) are the most frequent genetic causes of FTD (15%), FTD-ALS     (65%) and ALS (40%).      FTD is difficult at an early stage; and no clinical, biological or imaging features can     predict the underlying pathology in living patients. Therapeutic perspectives emerged against     tau aggregation, progranulin deficit and C9orf72 expansion (antisense). Presymptomatic     carriers of genetic FTD would benefit, before onset of symptoms, from these therapeutic that     would delay or prevent the disease. At this step, it becomes crucial to develop markers to     know how many years before symptoms, does the pathological progress begin, to treat the     patients at the most early stage of the disease. Markers are also needed to predict the     pathology (FTD-TDP/FTD-tau) in patients that will be eligible for trials targeting specific     pathological lesion.   "
53120|NCT02590263|"     This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of     ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health     Organization (WHO) grade III or IV malignant glioma.   "
53121|NCT02590250|"     This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of     BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to     neurogenic detrusor overactivity or overactive bladder.   "
53122|NCT02590237|"     The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope     performs as well as direct laryngoscopy for intubating small children and infants.   "
53145|NCT02589938|"     This study is being done to find out what effects, good and/or bad, acupuncture has on     participants and their xerostomia caused by radiation therapy for the treatment of the     cancer.   "
53123|NCT02590224|"     Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting     22% of pregnant women in industrialized countries and 52% in non-industrialized countries.     Iron deficiency anemia during pregnancy is associated with increased maternal as well as     fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss.     Therefore, routine iron supplementation during the second half of pregnancy has been     recommended once daily. Others, however, support a selective iron supplementation only for     women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration     associated with routine iron supplementation. Unfortunately, compliance to either     iron-supplementation programs, especially among pregnant women, is poor, due in part to the     side effects associated with these preparations.      Currently, there are many iron preparations available containing different types of iron     salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug     reactions found with these preparations are mainly gastrointestinal intolerance like nausea,     vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted     chelated amino acid form of iron) rarely make complication.      Product resulting from the reaction of a metal ion from a soluble salt with amino acids to     form coordinate covalent bonds, the resulting molecule is called as chelate and chemical     bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally     nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by     the binding of two molecules of glycine to one Fe2+ atom.   "
53124|NCT02590211|"     The PERHAPS project aims to fill two gaps in the scientific literature: on the one hand,     studying the clinical and cognitive particularities of poker-related problems, and on the     other hand, studying poker skill as a combination of multiple cognitive and emotional     abilities. The underlying clinical aim is to develop a cognitive remediation therapy program     dedicated to pathological gamblers.   "
53125|NCT02590198|"     Neonatal bacterial infection remains a serious pathology in industrialized countries despite     the use of prophylaxis measures for group B streptococcus (GBS) (peri-partum antibiotic in     women with GBS colonization), which was implemented in the United States in 1996 and in     France in 2001 and has led to a dramatic decrease in the incidence of neonatal bacterial     infections. However, early onset neonatal infection (EONI), which is defined as an infection     occurring during the first 6 days after birth (as opposed to late onset neonatal infections     (LONI) occurring between days 7-89), is still one of the leading causes of neonatal morbidity     and mortality. Physicians consider EONI a significant diagnostic and therapeutic emergency     due to the potential for sudden onset and rapid evolution of sepsis in newborns with immature     immune systems. Currently, in France, detection of EONI is based on national consensus     guidelines published in 2002 (ANAES recommendations). There are broad indications to provide     empirical antibiotic treatment pending diagnostic confirmation through different     complementary exams. To ensure that every infected newborn is diagnosed, biological     assessments are often repeated and result in the use of invasive and painful procedures,     anemia and financial concerns. Moreover, in cases of abnormal biological results, many     newborns are subjected to intravenous (IV) antibiotic treatments requiring hospitalization     and separation from their mother. However recent studies have shown that antibiotics can have     a potentially deleterious effect on the neonatal digestive microbiota and result in the     appearance of antibiotic-resistant bacteria, with possible long-term consequences on the     health of the child.      Procalcitonin (PCT) is a calcitonin prohormone secreted from the parenchymal tissues. This     marker of inflammation has been shown to be a valuable diagnostic marker for bacterial     infection in adults and in children. It also seems to be a reliable marker for neonatal     bacterial infection, which would make it useful in the detection of EONI. Because     physiological levels of PCT vary during the first days of life, possibly due to postnatal     intestinal bacterial colonization, levels of this marker are difficult to interpret in the     early neonatal period. However, in a study of 2151 newborns with suspected EONI, Nicolas     Joram et al. found that PCT obtained from the umbilical blood cord, prior to newborn     intestinal colonization, bypasses this postnatal physiological peak of PCT and effectively     constitutes a discriminant marker to distinguish between infected and healthy infants using a     cutoff value of 0.6 ng/ml.      Subsequent to this pilot study, several studies on PCT in umbilical blood cord confirmed its     good diagnostic performance for EONI, particularly when included in a diagnostic algorithm.     This marker could contribute to a better estimation of EONI risk in order to limit the use of     unnecessary complementary exams and prescription of antibiotics and their associated short-     and long-term side effects in healthy newborns.      Therefore, in this study, the investigators propose to test the diagnostic value of a     PCT-based algorithm in newborns suspected of having EONI. The investigators hypothesize that     this algorithm is as efficient as those currently used (ANAES), but will limit coinciding     biological exams and exposure to antibiotics during the neonatal period.   "
53151|NCT02589860|"     This is a pilot study to explore and identify changes in molecular processes within the oral     mucosa that are associated with the development of oral mucositis (OM) in patients treated     with Melphalan who undergo autologous peripheral blood stem cell transplantation.   "
53126|NCT02590185|"     Regarding the direct costs and the social value of depression, the decision of an     antidepressant treatment prescription must be optimized as much as possible. The development     of a personalized medicine in psychiatry may reduce treatment failure, intolerance or     resistance, and hence burden and costs of affective disorders.      There is hope that biomarkers will be found to guide treatment selection. It might be of     decisive interest to be able to assess an individual's metabolism activity. We propose here     to explore the relationship between the activity of drug-metabolizing enzymes (DME) and     transporters- assessed by a phenotypic approach and the efficacy of antidepressants. We will     focus on venlafaxine (V) that provides a reasonable second-step choice for patients with     depression and is used extensively in psychiatric practice, and the metabolism of which     involves several cytochromes (CYP) P450 enzymes and the transporter P-gp.      Thus, the primary objective of this study is to study the correlation between the     concentration of V and its metabolite ODesmethylV (V+ODV) and drug metabolism variability     assessed by a phenotypic approach, in patients with major depressive disorder and MADRS ≥ 20     despite 4 weeks of V at 150mg or less   "
53127|NCT02590172|"     In France, Intensive Medicine is carried out in three types of structures: intensive care     units, intensive care unit and units Continuous Monitoring (USC). Created in the 90s as     intermediate structures between conventional care units and intensive care units, these units     are assigned to the care of patients whose conditions and treatment are fear the occurrence     of one or more critical failures requiring to be monitored, or whose condition, at the end of     one or more critical failure is too severe or unstable to allow a return to a classical     inpatient unit.      Thus, USC represent a milestone in the journey of patients whose condition is critical:     patients from the emergency services, patients in the immediate postoperative period, coming     out of intensive care patients, or finally in conventional hospitalization patients whose     condition s 'worse. The creation of the USC is not subject to authorization but must be     contractualized between the hospital and the Regional Health Agency (ARS) because it is     resource intensive. Organizations and their operating modes are guided by the recommendations     of the French Society of Anesthesia and Intensive Care (SFAR), and the Society of French     Language Resuscitation (SRLF) published in 2005.The US establishment has a beneficial effect     on the quality of care and the care pathway of patients at risk shown by the reduction in     morbidity and mortality, the rate of admission and / or USC readmission of length of stay and     hospital stay costs.      It is possible to objectify provided first establish an inventory on the activity of these     units and the patient base supported. To judge the benefit of the assumption by the USC, it     is necessary to assess the adequacy of patients managed with an updated specification and     defined by a group of experts.   "
53128|NCT02590159|"     Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive     sleep apnea for the purpose of obtaining safety and efficacy data   "
53129|NCT02590146|"     This study will examine the use of non-pharmacologic pain control techniques and     pain-management counseling as an additional tool for reducing pain during first trimester     aspiration abortion.   "
53130|NCT02590133|"     We define refractory nasopharyngeal carcinoma as the following: recurrence with radiation     brain injury after radiotherapy, recurrence after the second or more courses of radiotherapy,     standard treatment failure after recurrence, and first-line treatment failure after multiple     distant metastasis.      There is no standard treatment for refractory nasopharyngeal carcinoma. Platinum plus 5-Fu is     the classic regimen for primary treatment of nasopharyngeal carcinoma.      Endostatin is a multiple targeted angiogenesis inhibitor acting on tumor associated     neovascular endothelial cells, normalizing the morphology and function of tumor vasculature,     and indirectly leading to the quiescence or reduction of tumors.      The purpose of this phase II clinical trial is to determine the efficacy and safety of     nedaplatin plus continuous low dose 5-Fu intravenous infusion combined with endostar®     (Recombinant Human Endostatin Injection) continuous intravenous infusion compared with     nedaplatin plus continuous low dose 5-Fu intravenous infusion alone in refractory     nasopharyngeal carcinoma.      The study hypothesis is that nedaplatin plus continuous low dose 5-Fu intravenous infusion     combined with endostar® continuous intravenous infusion is effective and safe in refractory     nasopharyngeal carcinoma.   "
53131|NCT02590120|"     The purpose of this study is to evaluate amino acid absorption with two different type of     proteins.   "
68104|NCT02394314|"     A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the     safety and pharmacokinetics of MEDI0382 in healthy volunteers.   "
53132|NCT02590107|"     This clinical trial studies the use of early oral supplementation in improving nutritional     status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional     status in participants undergoing hematopoietic stem cell transplant has been linked to     decreased outcomes such as increased length of hospital stay and increased time to     engraftment (an important milestone in transplant recovery). Early oral supplementation may     increase nutritional status and help to promote a positive outcome in participants undergoing     transplant.   "
53133|NCT02590094|"     Proliferative diabetic retinopathy patients requiring pars plana vitrectomy receiving     preoperative 0.625 mg intravitreal bevacizumab 3-10 days prior to vitrectomy will have     similar surgery times and similar intra-operative and postoperative complications to subjects     who receive preoperative 1.25 mg intravitreal bevacizumab at both 3-5 days, and 6-10 days     prior to vitrectomy.   "
53134|NCT02590081|"     This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy     and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in     wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with     respect to systolic blood pressure control over 3 months period.      The primary objective is to establish efficacy of 5% dextrose solution compared with normal     saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in     subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives     include monitoring the change in body weight, thirst level and body fluid volume.   "
53152|NCT02589847|"     This study will evaluate efficacy and safety information about RBX2660 for the treatment of     recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment     with RBX2660 (microbiota suspension).   "
70532|NCT02362542|"     The purpose of this study is to investigate the effect of Transcranial Direct Current     Stimulation (tDCS) on appetite control related brain regions.   "
53135|NCT02590068|"     This study aims to identify the innate and adaptive immune response to zoster vaccination.     Half of the participants will be individuals with chronic hepatitis C, while the other half     with healthy volunteers.The innate immune signature elicited by Zoster vaccination will be     characterized by RNA-seq analysis of pre- and post-vaccination RNA from whole blood. We will     compare fold changes in gene expression profiles pre- versus post-vaccination in each     individual, as well as between the two arms of the study. RNA-seq will be used to assess     innate immune activation by evaluating the changes to the expression levels of     interferon-stimulated genes pre- and post-vaccination. Adaptive immune response will be     determined by the traditional correlates of protection used in previous Zoster clinical     studies in addition to flow cytometry24. Correlates of protection include antibody response,     interferon gamma production and the frequency of responder cells post- vaccination24. For     antibody production, we will perform Zoster glycoprotein ELISA (gpELISA) targeting IgG/IgM.     The number and frequency of responder cells will be characterized by flow cytometry.   "
53136|NCT02590055|"     It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with     carcinoma of unknown primary.   "
53137|NCT02590042|"     A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using     ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing     stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from     a patient. As a cellular therapy product, ADSC-SVF-002 (fresh or cryopreserved) will be     administered subcutaneously via injection, with or without unprocessed autologous fat (fresh     or cryopreserved), into soft tissue defects and abnormally healing wounds. The primary     objective of the trial is to demonstrate the safety of ADSC-SVF-002 in a population of     subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite     being managed by conventional therapies.   "
53138|NCT02590029|"     The purpose of this randomized study is to determine the impact of three different types of     psychosocial support delivered by social workers to patients reporting uncontrolled pain     during a hospital stay. This study will examine the differential effects of brief mindfulness     training, therapeutic suggestion, and psychoeducation for patients reporting uncontrolled     pain.   "
53139|NCT02590016|"     Pregnant women with gestational diabetes who are treated with insulin and their daily insulin     dose is 30 IU or more will be randomized into two groups. Active treatment group will recieve     insulin-glucose-infusion during labour. In the observational group, blood glucose level     during labour will be monitored and insulin-glucose-infusion is started only if needed. The     hypothesis is that there will not be a difference in rate of hypoglycemia between the two     groups and that the proportion of observational group participants that need infusion is low.   "
53140|NCT02590003|"     This study will enroll elderly patients with advanced non-small cell lung cancer who are at     high risk of developing chemotherapy toxicity (side effects). Patients will receive treatment     with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single     agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity will be     compared in the two treatment groups to determine the best treatment strategy for this group     of patients.   "
53141|NCT02589990|"     The study investigates the effect of maximal strength training on muscular strength and power     in different age groups from 20 to 80 year old. It also relates the training adaptations to     different known genes such as angiotensin I-converting enzyme (ACE) and Alpha-actinin-3     (ACTN3). Participants will complete an eight weeks, three times per week training     intervention of maximal strength training with a pre-post design. In addition, blood samples     will be collected for the analyses of genetic variances.   "
53142|NCT02589977|"     Unlike heart failure with reduced ejection fraction (HFrEF) where several medicines and     devices have been demonstrated to reduce mortality, no such therapies have been identified in     HFpEF. This may be in part due to incomplete understanding of the underlying mechanisms of     HFpEF.      Recently, impaired myocardial blood flow, reduced myocardial energy utilization, and     increased myocardial fibrosis have been postulated to play important pathophysiologic roles     in HFpEF. The investigators and others have demonstrated that HFrEF may be associated with     altered myocardial energy utilization and energy starvation. However, there are limited     data regarding energy starvation in HFpEF and the relationships between myocardial blood     flow, energy utilization, and fibrosis in HFpEF are largely unknown. Therefore, the purposes     of this study are to use non-invasive cardiac imaging techniques to describe cardiac     structure, function, blood flow, energetics, and fibrosis, and the relationships between     these in order to better understand underlying mechanisms in HFpEF.   "
53143|NCT02589964|"     The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of     antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in     pneumonia patients.   "
53147|NCT02589912|"     The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for     restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients. This device has     been discontinued, meaning that there is no commercially approved device currently available.     The replacement model, the ABI541 (an unapproved device), is being investigated in ongoing     clinical trials. A compassionate use arm of a clinical trial allows patients with NF2 to be     implanted with this new ABI.   "
53148|NCT02589899|"     A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it     from other tissue types has been developed in a porcine model, by analysing a complex     impedance dataset based on multiple measurement frequencies. It must now be confirm that the     previous results are applicable in humans. Measurements from 24 predefined needle positions     will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new     algorithm to detect nerve tissue will be developed based on these measurement results.     Further impedance algorithms will be developed for other tissue type. The efficacy of the     algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers     (part B).   "
53149|NCT02589886|"     A randomised trial to the effect of a newly developed education and self help intervention     for patients with a functional motor disorder on general health, quality of life, illness     perception, symptom severity and other secondary outcome measures.   "
53907|NCT02579993|"     In this study the prognostic value of ABCB5 in survival of the limbal stem cell     transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in     patients with limbal stem cell deficiency will be analyzed.   "
53153|NCT02589834|"     Postoperative pain management is crucial for surgical patients. Management of postoperative     pain entails reducing painful symptoms, improving the quality of recovery and resuming normal     daily living activities. In addition to the benefits derived from relieving postoperative     pain in women undergoing cesarean section, prolonged immobility as a result of pain during     puerperium is associated with risk of thromboembolic disease.      Postoperative pain has negative physiological and psychological impact on patients'     well-beings and delays the postoperative recovery. Pain may also impair the mother's ability     to provide an optimal care for her infant in the immediate postpartum period. Besides that,     it also reduces the maternal ability to breast-feed her infant effectively.      Effective pain relief should not interfere with the mother's ability to move around and care     for her infant, and that it results in no adverse neonatal effects in breast-feeding women.      Non-pharmacological techniques for reduction of pain are growing rapidly. Spiritual     intervention with listening to Quran recitations as an adjunctive therapy in the     postoperative period is a non-pharmacological technique that is inexpensive, non-invasive and     has no side-effects. Spiritual and Islamic implication could improve postoperative pain 6-8     hours and 24-30 hours in Muslim patients undergoing abdominal surgery. However, there is     limited number of published studies on the effect of spiritual and religious intervention on     pain after cesarean section.      Listening to Quran recitation elicits a relaxation response of calmness, mindfulness, and     peacefulness in Muslims. Pray therapy results in optimal harmonization, which improves     psychological, social, spiritual, and physical health status.      The current study aims to investigate the effects of listening to Quran recitation on pain     intensity among patients after cesarean section according to the cultural, social and     economic differences in Egypt.   "
53154|NCT02589821|"     A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the     efficacy of Sulfatinib 300 mg once a day in treating advanced pancreatic neuroendocrine     tumors.   "
53155|NCT02589808|"     This study will compare findings using a handheld ultrasound device (GE VScan) with those     using a diagnostic ultrasound machine in adult patients referred for transthoracic echo     (TTE), prior to non-cardiac surgery at Hammersmith Hospital, London.      The handheld TTE (VTTE) will follow the standard Hammersmith Hospital diagnostic TTE (DTTE)     protocol (with the exception of spectral Doppler) and will be reported on a simple 'tick box'     form. A different echocardiographer will then perform and report the DTTE as per routine     practice. The results from VTTE and DTTE will be directly compared. The echocardiographers     performing the VTTE and DTTE are all fully accredited in diagnostic TTE and will be blinded     to each others findings.      The study aims to recruit a total of 96 patients with an anticipated study completion date of     November 2015.   "
53156|NCT02589795|"     CUTHIVAC002 is a randomised Phase I study aimed at exploring the safety and immunogenicity of     two different modes of delivery of a deoxyribonucleic acid (DNA) vaccine (DNA-C CN54ENV) via     combined intramuscular and intradermal methods with and without electroporation, and boosted     with recombinant HIV CN54gp140 administered by intradermal injection in healthy volunteers.      The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced     antibody responses to boosting with recombinant protein by the intradermal method.   "
53157|NCT02589782|"     TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III     trial; evaluating short treatment regimens containing bedaquiline and pretomanid in     combination with existing and re-purposed anti-TB drugs for the treatment of biologically     confirmed pulmonary multi drug-resistant TB (MDR-TB).   "
53158|NCT02589769|"     A randomized controlled clinical trial comparing the effect of substitution of unsaturated     fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal     weight and obese subjects with elevated LDL cholesterol.   "
53190|NCT02589353|"     Although salivary contents play a major role in the early stage of food digestion process,     their role in taste perception of glucose polymers is essentially unknown. It is hypothesized     that the differences in salivary contents, more specifically salivary amylase concentration     and activity, influence taste perception of glucose polymers and ultimately eating behavior,     which is related to risks in various diseases. The current project is designed to investigate     2 aims. Aim 1 will investigate the variation in salivary contents across individuals and its     role in taste perception of glucose polymers. Aim 2 will focus on the role of salivary     contents in food liking and disliking.   "
53191|NCT02589340|"     The primary objective of this study is to evaluate the efficacy of buspirone in combination     with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's     disease (PD).   "
69471|NCT02376465|"     To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a     bowel preparation prior to colonoscopy in adult patients.   "
53159|NCT02589756|"     Obesity represents one of the most important public health challenges for the societies.     Although excess energy intake and physical inactivity are major causes of obesity and     cardiometabolic disorders, emerging evidence has linked persistent organic pollutants (POPs)     with the global epidemic of type 2 diabetes. However, the potential impacts of POPs on     obesity and cardiometabolic risk in humans remain poorly known. On the other side systematic     reviews and meta-analyses conducted in recent years strongly support a protective association     between eating nuts and CVD. The investigators will conduct a randomized controlled clinical     trial in adults. The main research questions are: a. Does consumption of fatty fish increase     levels of POPs in overweight and obese adult norwegian men and women compared to a control     group not consuming fatty fish? b. Does consumption of fatty fish affect markers of     cardiometabolic risks (blood pressure, lipids, glucose and CRP) in overweight and obese adult     norwegian men and women compared to a control group not consuming fatty fish? c. Does     consumption of nuts improve markers of cardiometabolic risks in overweight and obese adult     Norwegian men and women compared:1. to a control group not consuming nuts or fatty fish and     2. to a group consuming fatty fish.      Clinical significance of study: If an increase in POP levels is seen, and correlates with     cardiometabolic risks, this may indicate the need to look further at a causal relation     between POPs and cardiometabolic disease and risk factors particularly type 2 diabetes. If     eating nuts improves CVD risk factors compared to not eating nuts, or to eating fatty fish,     this could be important dietary information for populations at high risk of CVD.   "
53160|NCT02589743|"     This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on     occlusal surfaces previously coated with intermediary bonding layer and it determined caries     incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal     Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.   "
53161|NCT02589730|"     The purpose of this study was to explore a model suitable for the individualized diabetic     management based on the mobile application coaching and demonstrate its effect among the     diabetic mellitus population.   "
56891|NCT02540954|"     To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT)     treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)   "
53164|NCT02589691|"     The prevention of the occurrence of respiratory events is a constant concern in pediatric     anesthesia, as these represent the main cause of the anesthesic mortality. These events occur     partly during induction of anesthesia and are all the more frequent as the child is young.      The French recommendations do not propose the use of neuromuscular-blocking agents in     pediatric anesthesia. This recommendation is controversial In a recently published study, it     has been shown that the use of neuromuscular blocking agents during induction in children     under 2 years improves intubating conditions and reduces the incidence of hemodynamic and     respiratory events. This monocentric study, centered on intubating conditions, does not allow     to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity.      The objective of study is to demonstrate that, in children under 2 years, changing the     anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated     with respiratory events occurring during induction   "
53165|NCT02589678|"     Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus,     diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to     simulate a vaccine efficacy trial to see if single women can participate in studies that     mimic actual HIV vaccine studies.   "
53166|NCT02589665|"     The main purpose of this study is to test the hypothesis that treatment with mirikizumab is     superior to placebo in providing clinical benefit to participants with moderate to severe     ulcerative colitis (UC). This study will also investigate how the body processes the drug.   "
53167|NCT02589652|"     This is a multicenter, prospective cohort study to evaluate the efficacy and safety of     sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis     B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to     those who continued on ETV therapy.   "
53168|NCT02589639|"     This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group,     efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with     Type 2 Diabetes Mellitus with insufficient glycaemic control   "
53169|NCT02589626|"     This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study     of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus     with insufficient glycaemic control   "
53170|NCT02589613|"     The objective is to investigate neuro-anatomical correlates of the regulation of energy     intake by means of functional MRI. Administration of glucose as well as fructose is followed     by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1     (GLP-1) levels as an endogenous satiety signal in obese humans.   "
53171|NCT02589600|"     The goal of this study is to perform the first fracture reduction clinical trial with a     potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term     care population.   "
53172|NCT02589587|"     Morbidly obese patients exhibit impaired secretion of satiation hormones which may contribute     to the development of obesity. Bariatric surgery is associated with weight loss and dramatic     increase in the secretion of satiation hormones, but the underlying mechanism remains     unknown. The investigator's goal is therefore to examine patients before and after sleeve     gastrectomy and compare findings to lean controls.   "
53192|NCT02589327|"     Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac     and metabolic risk. The aim of this study the effects of exercise in cardiac fat content,     cardiac function, physical fitness, and metabolic activity in obesity.   "
53193|NCT02589314|"     This study will evaluate if periodontal mechanical treatment is capable to alter     immunological and genetical parameters related to systemic health in patients with chronic     periodontitis ant diabetes type 2.   "
71364|NCT02351648|"     To find out if a transitional care model can reduce the rate of unscheduled readmission to     the Department of Internal Medicine (DIM) in SGH   "
53173|NCT02589574|"     Influenza is an important cause of medical visits and worker absenteeism among healthy     adults. Studies of healthcare providers vaccination programmes have reported a positive     effect in lowering rates of influenza like illness and influenza related complication,     hospitalisation and death. Nurses should receive influenza vaccination so that those patients     who may come in contact with will not be infected by their nurses. However, the immunization     rate among nurses is constantly low. Therefore, it is important to develop an intervention     programmes to increase immunization of nurses. In some research on electronic text messaging     in promoting public health showed potential of this communication system in preventive health     behavioural change. With the use of this widely acceptable, accessible and convenient     approach of communication, reminders of receiving influenza vaccination are sent to nurses     involved in this study. At the same time, educational messages are sent to modify their     perception on the positive effect of influenza vaccination, and therefore, motivate the     nurses to receive the vaccination. The study will be conducted as a two-arm randomised     controlled trial which the control and intervention groups will run concurrently. Nurses of a     local hospital are invited to participate in this study. They will receive the usual     announcement on the information of free influenza vaccination of the hospital. The     participants of the intervention group will also receive text message reminders on details     for free influenza vaccine and educational information. All communication occurred through     secure, asynchronous electronic text messages. The reminders and educational information are     developed with reference to promotion messages from the Department of Health under the     framework of Health Belief Model so as to promote positive perception on influenza     vaccination by the participants. Participants are invited to complete the pre and post     questionnaires before and after the study period. The influenza vaccination status of the     participants and their perception on influenza vaccination will be obtained. It is     hypothesised that the participants receiving the reminders and educational information will     more likely to receive influenza vaccine and perceived the influenza vaccination as important     measure in protecting them from influenza. The participants of the intervention group will     also receptive to electronic text messaging communication and education.   "
53174|NCT02589561|"     Currently, the fitting of hearing aids is using a computer interface that allows to adjust     the gain and compression of acoustic amplification. This adjustment is made face to face,     patient and audiologist being located in a soundproof space to test the effectiveness of the     hearing aid.      However, advances in telemedicine in this context, let consider the possibility of addressing     these hearing aids fitting via the same computer interface, but remotely controlled by the     hearing care professional. The purpose of this study is to assess the ability to perform     these tests no longer in front of the patient settings, but away from it, and without visual     and sound contact other than through a computer interface.      At the end, this project wants to show that a remote fitting is an acceptable procedure that     provides comparable results to-face fitting in terms of speech perception, speech in noise     audiometry, hearing loss related quality of life in order to be able to offer this type of     strategy.   "
53175|NCT02589548|"     The study is a prospective registry of Hodgkin Lymphoma (HL) patients in Brazil.      The purpose of the study is to gather clinical, epidemiologic and outcomes data on the     treatment of HL, on the basis of records collected by key Brazilian institutions, through a     centralized web-based registry of clinical data verified by central board of     hematopathologists.   "
53176|NCT02589535|"     Septic shock is a systemic inflammatory response syndrome with acute circulatory failure     secondary to a documented infection. It is the most feared complication in ICU patients, with     a 50% mortality rate.      The study of stem cells and their experimental use in sepsis treatment is particularly     relevant in the international scientific research, where Italy plays an important role. In     the vast and complex field of stem cell research, the primary aim of the current proposal is     to evaluate the time course level of circulating endothelial progenitor stem cells CD34 + /     CD133 + (EPCs), and some factors EPCs-related, such as hypoxia- inducible factor (HIF- 1) and     stromal derived factor-1 (SDF-1) in septic patients undergoing major abdominal surgery.      The secondary objectives of the project are: determine cut-off values of EPCs , HIF -1 and     SDF-1 related to sepsis score from literature and their time course variation in patients     receiving conventional treatment according to the Surviving Sepsis Campaign guidelines,with     or without extracorporeal hemoperfusion therapy.   "
53177|NCT02589522|"     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970     (VX-970) when given together with whole brain radiation therapy in treating patients with     non-small cell lung cancer that has spread from the original (primary) tumor to the brain.     ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells     and shrink tumors. Giving ATR kinase inhibitor VX-970 together with radiation therapy may be     a better treatment for non-small cell lung cancer.   "
53178|NCT02589509|"     The purpose of this study is to test an innovative combination of direct-attention training     and metacognitive training in the treatment of attention impairments in Veterans with     moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems.     Enrolled participants will be randomized to receive either the direct-attention training or     metacognitive training first and then will be crossed over to receive the opposite     intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment     4 weeks later. In addition to the rehabilitation treatments, participants will also perform     measures of complex functional activities (e.g., independent activities of daily living or     IADLs) and neurocognitive tests of attention-control functions. Participants will also     perform an attentional task that probes the function of three different attentional systems     while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to     assess changes in brain function that may be improved by the rehabilitation approach. Planned     enrollment will be 36 Veterans.   "
53194|NCT02589301|"     This study will evaluate the pharmacokinetics (relative bioavailability) and     pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes,     between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and Neulastim®     (reference formulation), marketed by Produtos Roche Químicos e Farmacêuticos S/A.      In addition to that, a pharmacodynamics comparison will be performed, through change in     absolute neutrophil count in leukogram performed in the same time of pharmacokinetics     analysis collection and through CD34+ cell count in peripheral blood at timepoints 0:00,     96:00 and 384:00 hours.   "
53195|NCT02589288|"     The aim of this prospective, randomized , blinded study is to compare two different infusion     techniques (continuous VS intermittent automatic bolus) to assess the effects of     postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.   "
53196|NCT02589275|"     This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and     efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of     Fibromyalgia (FM). Patients recruits into this trial are those who have successfully     completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Anticipated start for     TNX-CY-F302 is for March 2016.      Patients will not be made aware of the therapy they received during the double-blind study.   "
55910|NCT02553798|"     This is an open-label, long-term safety study of DRM04 Topical Wipes, enrolling up to 660     subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or     DRM04-HH05 studies.   "
53179|NCT02589496|"     Gastric cancer (GC) is the second most common cause of cancer related mortality and the     fourth most common cancer worldwide. The molecular classification of GC and the relevance of     pre-clinical models are not well established, creating challenges in discovering novel     molecularly targeted therapies. In order to address these issues, we conducted an integrated     molecular data analysis of three hundred Asian Gastric tumors through the Asian Cancer     Research Group (ACRG). We performed an integrated genomic analyses based on target     sequencing, gene expression profiling, copy number variations, Lauren's histological     classification, Epstein Barr Virus (EBV) status, TP53 status in three hundred GC specimens.      We first divided GC into four subgroups based on gene expression profiling and TP53 status:        1. epithelial MSS-TP53 inactive;        2. epithelial MSS-TP53 active;        3. MSI; and        4. mesenchymal.      With an integrative analysis with target sequencing and copy number variations, epithelial     MSS-TP53 inactive GCs are characterized by predominantly hypermutated intestinal tumors     (including majority of mutations in KRAS) with MLH1 loss through promoter methylation and     MSS-TP53 active GCs are characterized by intact TP53 pathway with high frequency of EBV     infection or frequently mutated oncogenes (e.g. PIK3CA). MSI subtype with TP53 pathway     inactive characterized by TP53 loss through deleterious mutations in TP53 or MDM2     amplification and further characterized by both focal amplifications in oncogenes such as     HER2, EGFR, cMET, CCNE1 as well as large scale chromosomal gains and losses. The above     subtypes exhibited differential prognosis with the mesenchymal subtype displaying the worst     survival (2.2 years) and the MSI subtype the most favorable survival (5.6 years). The GC     subtypes and their association with prognosis were independently validated in three GC     cohorts. We additionally showed significant association of global gene expression immune     patterns, like adaptive immune system and inflammation, as well as expression of PD-L1, with     the genomic defined subtypes.      In the phase Ib KEYNOTE-012 study which evaluated pembrolizumab monotherapy at 10 mg/kg ever     2 weeks in patients with gastric cancer were recently reported. Most patients had two or more     prior lines of therapy. In the study, 41% of evaluable patients showed tumor shrinkage. The     overall response rate in 39 patients were 31%.      The preliminary data showed a Not significant correlation between PD-L-1 expression and ORR     (P=0.071).      Given the mutual association of tumor genetic markers, gene expression and potential markers     of response to immune therapy identified through the collaborative work between SMC and MERCK     MSD and Lilly, we plan to perform a phase II study with integrative genomic analysis (whole     exome and RNA sequencing) in pre and post biopsy specimens to better define those GCs who may     benefit from pembro.   "
53180|NCT02589483|"     The anastomotic leaks are multivariable in its origin. The incidence varies among different     centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be     devastating for the patient and very costly for the health care system.      Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences.      The future of colorectal surgery will increasingly include older patients with increased     preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it     suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks     spectrum into a subclinical and therefore self-healing one.   "
57269|NCT02535949|"     The purpose of this study is to evaluate the effects of TXA on the immune system, its     pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.   "
53181|NCT02589470|"     Studies on the cognitive function have highlighted promising results concerning attention. In     contrast, in the field of memory, the single cohort study that has been carried out, has not     been randomised, with non comparable groups, the significant outcomes are therefore to be     balanced.      In this study, patients with focal and structural temporal lobe epilepsy will be randomised     in 2 groups : the COMETE group where patients will attend a specific rehabilitation programme     of memory and the control group where patients will benefit from a standard treatment.   "
53182|NCT02589457|"     The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir     Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male     volunteers.   "
53183|NCT02589444|"     The objective of this study is to assess the effects of a high-dose vitamin D3 on the     composition of gut and lung microbiota in adolescents and adults with cystic fibrosis who are     vitamin D deficient.   "
53184|NCT02589431|"     Background: The purpose of the present study was to compare serum total cortisol (STC),     salivary cortisol (SaC) and calculated free cortisol (cFC) levels at the baseline and after     the ACTH stimulation test, in patients with severe sepsis (SS) and to determine the     suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency     in patients with SS.      Methods: Thirty patients with SS (15 men, and 15 women) were compared with 16 healthy     controls. Low dose ACTH stimulation test (1 µg) was performed on the first, 7th and 28th days     of diagnosis of SS. STC and SaC levels were measured during ACTH stimulation test.   "
53185|NCT02589418|"     The investigators will assess the effects of manual acupuncture on experimental dental pain     in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific     autonomic nervous system (ANS) reactions.   "
53186|NCT02589405|"     The aim of this study is to evaluate a complete acne regimen consisting of a medication     (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil®     Dermacontrol Moisturizer SPF30 in patients with acne.   "
53187|NCT02589392|"     The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring     moisturizer in reducing the signs and symptoms of very dry atopic skin in young children.     Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either     Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association     with Cetaphil® Restoraderm® skin restoring moisturizer.   "
53188|NCT02589379|"     The purpose of this study is to assess the value of preoperative objective modalities such as     endoscopic ultrasound elastography and magnet resonance imaging in predicting development of     postoperative pancreatic fistula in patients undergoing pancreatic surgery for benign or     malignant disease.   "
53189|NCT02589366|"     Part of standard treatment for endometrial cancer is to remove one or more groups of lymph     nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the     body throughout the lymphatic system (the tissues and organs involved in immunity, which aids     in the fight against infection and cancer).      The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue     Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the     lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to     remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as     well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track     of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be     sent to another doctor to view them under a microscope and see if the nodes contain cancer     cells.      The hypothesis is that Lymphoseek can be used safely and will be at least as effective as     blue dye in identifying the lymph nodes that may have cancer cells.   "
53216|NCT02589015|"     The aim of this study is to determine the correlation of neck circumference with difficult     mask ventilation and laryngoscopy in morbidly obese patients.   "
53217|NCT02589002|"     In this study the effects of sucralose on insulin sensitivity, beta-cell response and     appetite regulating hormones will be evaluated.   "
53218|NCT02588989|"     The aim of this project is to better evaluate the systemic right ventricular (RV) function in     patients with transposition of the great arteries (TGA).   "
53197|NCT02589262|"     The study medicine is a potential future treatment for schizophrenia, an illness that affects     the way that people think, feel or behave. It is not clear what causes schizophrenia, but     it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will     activate specific sites in the brain to help correct that imbalance. Current treatments for     schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that     the study medicine will work better, and have fewer side effects than existing medicines.      In this 2 part study (Parts A and B), the primary aim is to assess how safe the study     medicine is in healthy men, aged 18-45 years, and how much of it gets into the blood. Its     effects on the brain will also be tested.      In Part A, up to 24 participants will receive up to 5 single doses of the study medicine     (AUT00206 or placebo) by mouth, either after fasting or after a high fat breakfast. The study     medicine has never been given to humans before, so the initial doses will be small and the     dose level will be increased as the study progresses. Participants may take up to 14 weeks to     finish the study. They'll make up to 22 outpatient visits, and stay on the ward up to 5     times, for 3 nights in a row each time.      In Part B, 24 participants will receive daily doses of the study medicine (AUT00206 or     placebo) for up to 28 days. Participants will take up to 10 weeks to finish the study.     They'll make 6 outpatient visits, and stay on the ward for up to 30 nights, depending on how     long we expect it to take until blood levels of the study medicine level off.      A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will     take place at 1 centre in London.   "
53198|NCT02589249|"     The purpose of this 12-week, prospective study is to determine the effects of oral     supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility,     joint comfort and functional capacity in healthy overweight subjects.   "
53199|NCT02589236|"     This will be a double-blind, randomized, placebo-controlled, parallel group study. The     purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in     adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated     with lumacaftor/ivacaftor (Orkambi™).   "
53200|NCT02589223|"     St. Michael's Hospital (SMH) provides service to individuals with some of the most severe     brain injuries and intensive care needs in Canada. These patients often require prolonged     intensive care admissions, lengthy hospital stays, involvement of many health professionals,     and long-term support for ongoing care requirements. Many hospitals face resource     limitations, specifically involving the health disciplines and their ability to provide     frequent intervention.      It has been proposed that multisensory stimulation (i.e. exposing the patient to various     sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in     improved responsiveness/cognitive function.      Previous research has indicated a potential benefit for early multisensory stimulation     intervention for patients with severe brain injury. However there is still not enough     conclusive evidence to confirm whether the intervention is truly effective. The investigators     are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to     determine the feasibility and examine the effectiveness of early multisensory stimulation     with patients following severe brain injury who remain in a coma, vegetative state, or     minimally conscious state. Eligible patients will be randomized to a control group (standard     care + family/caregiver education) or an intervention group (standard care + family/caregiver     education + early sensory intervention). Data regarding number of patients enrolled, amount     of intervention completed, percentage of outcome data collected, patient's level of     responsiveness and cognitive function will be collected before and after the intervention     period, using several outcome measures. The investigators hope to determine the feasibility     of conducting this type of study within this clinical setting and the effectiveness of     multisensory stimulation with this patient population.   "
53201|NCT02589210|"     A single-centered, non-randomized study with approximately 20 subjects that will be seen for     up to 12 weeks, each receiving the EpiFix mesh plus standard of care. Safety and     effectiveness will be monitored throughout the study.   "
53202|NCT02589197|"     MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous     study which showed the Medial Pivot (MP) system required lower quadriceps activation than     subjects implanted with a Posterior stabilized (PS) system preforming the same activities of     daily living.   "
53203|NCT02589184|"     Determine if adding extra-gravity (sustained increase in vertical loading) during standard     rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from     shoulder pain of different origin.   "
53204|NCT02589171|"     The purpose of this study is to compare the neoClose abdominal closure to the standard     Carter-Thomason closure in a bariatric surgery gastric bypass population.   "
53205|NCT02589158|"     The purpose of this study is to look at the levels of three HIV medications: atazanavir,     darunavir and cobicistat in the blood after drug intake has been stopped, in order to     understand how long these drugs persist in the blood. The study will specifically look at     blood levels of these three drugs after taking them every day for 10 days. Participants will     take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and     cobicistat) on a second stage.      If the participants decide to take part, the duration of the study will be up to 33 days plus     a screening visit which will take place up to 28 days prior to the start of the study, and a     follow up visit, which takes place 7 to 14 days after the last dose of study medication. This     study is not randomised which means that all participants will receive all study medications     in the same order.      The participant and the study doctor will know which study medications the participant is     taking at all times during the study.   "
53206|NCT02589145|"     The goal of this clinical research study is to find the highest tolerable dose of     lenalidomide that can be given in combination with vorinostat, gemcitabine, busulfan, and     melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want     to learn about the safety and effectiveness of this combination.   "
53207|NCT02589132|"     Failure to Thrive negatively affects growth, cognition, behavior, and quality of life (QoL),     which can be devastating and enduring. These outcomes are high-cost and lead to increased     family stress and negatively affect the caregiver-child relationship. Therefore, families     need increased access to materials that will help them understand their child's health and     help them use new feeding behaviors to improve the child's nutrition and growth. Standard     care with the addition of Mobile Thrive (M-Thrive), our innovative smart phone-based mobile     app, is intended to demonstrate the clinical advantages of using mobile health technology     (mHealth) in comparison to standard care alone.   "
53254|NCT02588521|"     This randomized, double-blind, placebo-controlled, 4 part study will assess the safety,     tolerability, pharmacokinetics and antiviral activity of orally administered AL-794 in     healthy volunteers (HV).   "
53928|NCT02579720|"     The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex®     Quattro as a short-term revaccination in patients who have already been successfully     desensitized at least five years ago against grass-pollen but developed a recurrent allergy.   "
53208|NCT02589119|"     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer     using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20     million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas will     be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection     and placement of a draining seton. Six weeks post placement of the draining seton, the seton     will be replaced with the MSC loaded Gore Fistula Plug; fistula plug as per current clinical     practice. The subjects will be subsequently followed for fistula response and closure for 24     months. This is an autologous product derived from the patient and used only for the same     patient.   "
53209|NCT02589106|"     One of the most common types of 3-dimensional spinal deformities with unknown etiology in     youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty     progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for     moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously,     teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical     constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their     efficacy is still controversial and there are other issues, such as high pain scores. There     is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and     developed to correct spinal deformity, reduce the possibility of spinal curve progression,     and satisfy the needs of the patients as well as take their psychological concerns into     consideration.   "
53260|NCT02588443|"     The main purpose of this study is to learn if adding the investigational drug RO7009789     (anti-CD40) to nab-paclitaxel and gemcitabine both before surgery and after surgery is safe,     feasible, and beneficial to patients with pancreatic cancer. This study also intends to look     at blood and tissue samples to help doctors better understand the role of the immune system     in fighting cancer.   "
53261|NCT02588430|"     This study is a non-invasive registry to monitor the safety and efficacy of patients using     the CE-certified RETINA IMPLANT Alpha.   "
53210|NCT02589093|"     Anesthesiology daily practice consists in management of sedation, immobility and analgesia.     The monitoring of this last component remains largely based on indirect signs with poor     sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an     increased demand for more accurate analgesia monitors. Several parameters have been studied     in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate     variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic     tones, and is therefore influenced by pain and analgesia.      MDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called     PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index,     the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number     indicating less parasympathetic tone. It has been shown in previous studies under general     anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and     to increase with opioids administration.      The purpose of this study is to show a correlation between the variation of the ANI with pain     scores in awake healthy volunteers who are subjected to standardized painful stimuli of     increasing intensity. The investigators hypothesize that an increasing pain score will     correlate with decreasing ANI values.   "
53211|NCT02589080|"     Amputation of a limb may result from trauma or surgical intervention. The amputation     traumatically alters the body image, but often leaves sensations that refer to the missing     body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain     (PLP). Both peripheral and central nervous system factors have been implicated as     determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and     psychological factors (emotional stress). Recent evidence suggests that PLP may be     intricately related to neuroplastic changes in the cortex, and that these changes may     modulated by providing sensory input to the stump or amputation zone.      A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory     feedback build into a hand prosthesis to alleviate phantom limb pain.   "
53212|NCT02589067|"     The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus     despite the use of systemic antibiotic treatment, due to difficulties in decolonization and     the prevalence of antibiotic-resistant strains such as MRSA.      This problem will be studied through a randomized, double-blind, placebo-controlled clinical     trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus     in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in     children as its safety has been widely established, and it is readily commercially available.     Eligible, consented subjects will be asked to participate in a baseline study visit in which     swabs of their oropharynx and nares are obtained, and they are educated on the use of either     CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to     perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and     28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to     ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1)     determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the     safety, tolerability, and compliance of oropharyngeal decolonization among children and their     caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with     continued colonization.   "
53213|NCT02589054|"     Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical     environment to provide specific intraoperative anesthesia and postoperative analgesia.     Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then     sensory, then motor nerve function. Sympathectomy-induced vasodilation following brachial     plexus block results in increased skin temperature and arterial flow within minutes.      Although it has not been shown to reliably increase diameter or cross-sectional area of     distal arteries, brachial plexus block does change the pattern and quantity of blood flow to     the hand. Given that the magnitude of change of flow cannot be attributed to vessel radius,     the investigators suspect that the more laminar fluid dynamics are due to vascular tone.      The investigators study aims to quantify alterations in physiology and peripheral vasodilator     response. The investigators anticipate that axially block will significantly improve regional     blood flow.   "
53214|NCT02589041|"     This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal Effective     Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with Up-and-down     methodology.      To evaluate any neurological complications, an electrophysiological assessment will also be     performed preoperatively and at 5 weeks after surgery.   "
53215|NCT02589028|"     The aim of this study is to explore premeal protein-enriched bar effect in postprandial     glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1)     and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with     type 2 diabetes.   "
53219|NCT02588976|"     The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform     kaolin-based activated clotting time as routine monitor of heparin therapy in patients     undergoing cardiac operations. In addition, the device allows the assessment of the patient's     coagulation status by a glass-bead activated test. Recently, a new SONOCLOT analyzer (S2) has     been developed. As part of the routine management using S1, tests are also performed on S2.     Results are entered into the cardiac surgery data base of all cardiac surgery patients and     analyzed.   "
53220|NCT02588963|"     The aim of this study is to evaluate the influence of Primary and Secondary Prevention of     Respiratory Infections in children up to 3 years-old attending daycare.   "
53221|NCT02588950|"     This purpose of this two-part study is to measure how much of the study drug gets into the     blood stream and how long it takes the body to get rid of it. In Part A, each participant     will receive two treatments, a single dose and a continuous dose of U-500R insulin, both     administered just under the skin. Participants who complete Part A will continue into Part B     where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice     or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks     including initial screening and follow up.   "
53222|NCT02588937|"     The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT.     in chronic hepatitis B Patients.   "
53262|NCT02588417|"     To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in     combined spinal epidural (CSE) analgesia during vaginal delivery.   "
53223|NCT02588924|"     The Department of Experimental Medicine - Section of Hygiene, Occupational Medicine, Forensic     Medicine of the Second University of Naples, the Section of Neurology of the Second     University of Naples and the Mediterranean Neurological Institute NEUROMED, IRCCS are     involved in the realization of a research project aimed at studying the correlation between     environmental and occupational exposure to metals (copper, iron and manganese) and Parkinson     disease in order to increase the knowledge of these possible risk factors and highlight an     eventual predictive-diagnostic meaning of possible discrepancies in the content of these     elements; secondly the collected data could be used for assessing the association (odd     ratio-OR) between pathologies and different risk factors (for example smoking habits,     professional exposure and so on).   "
53224|NCT02588911|"     The current study was a double blind randomised controlled trial that compared radiofrequency     ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls     and who had intact great saphenous veins (GSVs).   "
53225|NCT02588898|"     This case-control study investigated B-vitamin and homocysteine in relation to the presence     or the absence of type 2 diabetes and clinical signs of polyneuropathy.   "
53226|NCT02588885|"     This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological     and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms     (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Patients     will be recruited after being referred to pelvic floor physical therapy for treatment of     chronic pelvic pain. Participants will complete seven sessions of individual cognitive     behavioral psychotherapy. Physical therapy will be provided by clinicians who have been     trained in trauma-sensitive treatment techniques. Treatment acceptability and outcomes will     be assessed at baseline, mid intervention, post-intervention and follow-up via self-report     measures. The RESPECT protocol is expected to be feasible to implement among sexual abuse     survivors and to be well liked by patients. RESPECT is expected to reduce chronic pelvic     pain, PTS, dysfunctional sexual behavior, treatment avoidance.   "
53227|NCT02588872|"     In this, prospective, double-blind study, patients with mild to moderate symptomatic knee     osteoarthritis will be randomized to receive either a series of leukocyte poor, platelet-rich     plasma or hyaluronic acid injections under ultrasound guidance. Clinical data in the form of     subjective outcome measures will be collected pre-treatment and at four time intervals across     a 1-year period. Synovial fluid will also collected for analysis of pro- and     anti-inflammatory markers pre-treatment, and at 12 and 24 weeks.   "
53228|NCT02588859|"     This is a multicentre, non-interventional, prospective, observational study which would be     conducted in India to understand the usage and effect of saxagliptin as first add-on therapy     after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were     inadequately controlled with metformin alone and have been recently prescribed saxagliptin as     an add-on to metformin.   "
53229|NCT02588846|"     Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to     account for the relative motion of the moving prostate tumour target and the static pelvic     nodal target for high-risk prostate cancer patients. The capability of tracking for the     relative motion of multiple targets will ensure that all the treatment targets receive     correct dose as prescribed by the doctor and minimise side effects to the critical organs.   "
53230|NCT02588833|"     The objectives of the study are to assess the safety, tolerability, preliminary efficacy and     PK of multiple subcutaneous (SC) doses of APL-2 in subjects with paroxysmal nocturnal     hemoglobinuria (PNH) who have not received treatment with eculizumab in the past.      An exploratory objective of the study is to assess the pharmacodynamics (PD) of multiple SC     doses of APL 2 when administered to PNH patients.   "
53231|NCT02588820|"     Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir,     immune activation and inflammation in patients with HIV-1 infection of less than 20 days     (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages     III-V), to induce HIV functional cure.   "
53232|NCT02588807|"     The purpose of the study is to evaluate the safety of combining phospholipids with medicinal     plants for treatment of patients with amyotrophic lateral sclerosis (ALS)   "
53233|NCT02588794|"     Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney     injury in patients with severe sepsis/septic shock   "
53255|NCT02588508|"     This study evaluates the effectiveness of warm packs, perineal massage and hands off, during     labour, in the perineal outcomes. The perineal outcomes are perineal tears, grade of perineal     tears, need of suture, perineal edema, perineal pain, use of drugs for perineal pain, and     satisfaction with the technique used.   "
53288|NCT02588079|"     The purpose of this study is to determine whether internet-based cognitive behavioral therapy     (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The     investigators hypothesis is that children and adolescents who have been offered ICBT show     significant better performance on outcome measures compared with patients in control group.   "
53234|NCT02588781|"     Pemetrexed is an anticancer agent that exerts its action by disrupting crucial     folate-dependent metabolic processes essential for cell replication. In vitro studies have     shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate     synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide     formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo     biosynthesis of thymidine and purine nucleotides.Pemetrexed is used as a standard therapeutic     agent for lung cancer, pleural mesothelioma, peritoneal mesothelioma.In addition to these     effective anti-cancer effect, Pemetrexed is not severe side effects of the medicine.      Pemetrexed has been research in colon cancer. Zhang, etc., demonstrated the anti-cancer     effect of Pemetrexed in human colon cancer Cells.      Although sometimes made also two or more clinical studies, Pemetrexed was reported 15-17% of     the treatment response rate in these two studies.   "
53263|NCT02588404|"     The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in     patients with prostate cancer treated with radiation and hormonal therapy.   "
53356|NCT02587182|"     The objective of the present study was to assess the effectiveness of deep dry needling in     the masseter and temporalis MTrPs on pain, pressure pain threshold (PPT), range of motion and     disability in patients with sleep bruxism and myofascial temporomandibular disorders.   "
53235|NCT02588768|"     Background/Aim: While growing evidence supports the use of photobiomodulation therapy (PBMT)     for performance and recovery enhancement, there have only been laboratory-controlled studies.     Therefore, the aim of this study was to analyze the effects of PBMT in performance and     recovery of high-level rugby players during an anaerobic field test.      Methods: It is a randomized, crossover, double-blinded, placebo-controlled trial. Twelve male     high-level rugby athletes were recruited in this study. No intervention was performed before     the Bangsbo Sprint Test (BST) at familiarization phase (week 1). At weeks 2 and 3,     pre-exercise PBMT or placebo were randomly applied to each athlete. PBMT/placebo irradiation     was performed at 17 sites of each lower limb, employing a cluster with 12 diodes (4 laser     diodes of 905nm, 4 LED diodes of 875nm, and 4 LED diodes of 640nm, 30J per site -     manufactured by Multi Radiance Medical™). Average time of sprints, best time of sprints, and     fatigue index were obtained from BST. Blood lactate levels were assessed at baseline, and at     3, 10, 30 and 60 minutes after BST. Athletes' perceived fatigue was also assessed through a     questionnaire.   "
53236|NCT02588755|"     The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE)     plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative     resection   "
53237|NCT02588742|"     Delirium in older patients is associated with increased mortality and health care costs. And     delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the     most important risk factor for developing delirium. In this study, investigators will     investigate the effect of administration of melatonin on postoperative delirium in elderly     ICU patients.      Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening     from the day before surgery to the the 5th postoperation day. In contrast, patients in the     control group are given placebo.      Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC     (Intensive Care delirium Screening Checklist). And secondary outcome includes     intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood     pressure, total amount of sedatives, total amount of analgesics, duration of mechanical     ventilation, duration of ICU stay.      Thus, investigators perform this study to investigate the relationship between delirium and     circadian rhythm.   "
53238|NCT02588729|"     In this study, the investigators will test a new way to communicate advice on diet and     lifestyle to women with gestational diabetes mellitus by app downloaded on women`s     smartphone. The app wishes to motivate women to have a healthy diet, and be physically     active. It allows automatic transfer of blood glucose measures from the glucose meter to the     smartphone. The women will answer questionnaires during pregnancy and be followed up three     months postpartum.   "
53239|NCT02588716|"     To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in     cirrhotic patients undergoing major liver resections.   "
53240|NCT02588703|"     The current study evaluates the efficacy of Cognitive Behavioral Therapy (CBT) in DUI     programs for individuals with a first-time offense. Investigators will utilize a two-group     randomized design where individuals enrolled in a DUI program with a first-time conviction     will be randomized to Cognitive Behavioral Therapy (CBT; n=150) or Usual Care (UC; n=150).     Participants will be assessed at baseline, immediately post-treatment, and 6-months     post-treatment. Recidivism data will also be collected using administrative data two years     post-treatment.   "
53241|NCT02588690|"     Cardiovascular disease (CVD) is the leading cause of death world-wide in women. Despite     current medical advances, heart disease is rising in relatively young women. Women access     primary care differently than men, most utilizing their Obstetrics-gynecology clinic for     primary care services. The recent implementation of the Affordable Care Act (ACA) aims to     provide increased access to primary care services, however, women are still not appropriately     risk stratified for CVD disease risk. Many women still are not aware that they are at risk     for CVD. This is particularly true for the 15-44 year old female age group. Lack of proper     risk stratification may be related to women not being properly identified or appropriately     referred to preventive cardiovascular services for treatment of traditional risk factors such     as diabetes, obesity, hypertension, and dyslipidemia. These traditional risk markers serve as     examples of chronic diseases, which are not always recognized in the early stages and     therefore not optimally managed. Furthermore, if women are not feeling ill, they are less     likely to access their current primary care resources for preventive strategies.     Investigators propose to risk stratify women in places where they usually congregate. In     addition to convenience, current risk stratification is improved with the recent     implementation of the ASCVD risk calculator. Investigators hypothesize that if women were     properly risk stratified and referred to appropriate preventive cardiovascular risk clinics,     more preventive strategies could be implemented, therefore reducing the amount of unnecessary     premature disease in women. To achieve this ambitious goal, investigators propose a three     step, demonstration project.      The specific aims of this proposal is to:        1. Provide women with CVD risk stratification in places where they locally convene on a          daily basis.        2. To evaluate the efficacy of a lay professional to adequately assess CVD risk.        3. To evaluate if assessment of CVD risk reduces the amount of future CVD (unsure if this          can be measured in this project).      The specific aims:        1. Demonstrate feasibility and acceptability of strategies utilizing ASCVD risk assessment.        2. Improve ASCVD risk scores one year follow-up.        3. Increase heart disease awareness through marketing materials in women in Los Angeles.        4. Develop preliminary feasibility and efficacy data for a large clinical outcome trial.   "
53242|NCT02588677|"     The objective is to compare the efficacy and safety of masitinib in combination with riluzole     in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).   "
53243|NCT02588664|"     The purpose of this pragmatic study is to investigate whether implementation of a     comprehensive post-acute stroke service model that integrates Early Supported Discharge (ESD)     and Transitional Care Management (TCM) for stroke survivors discharged home improves     functional outcomes post-stroke, reduces caregiver stress, and reduces readmission rates.   "
53286|NCT02588105|"     The purpose of this study is to determine whether AZD0156 is safe, what is the best dose to     give, and how it is processed by the body when given alone or in combination with other     agents. The study will also collect some initial information about how effective it is.   "
53256|NCT02588495|"     During surgery, there is a risk that food or liquid in the stomach might be forced back up     the throat where it could enter the lungs (aspirate) and result in serious complications or     even death. This is why people going for surgery are required not to eat before their     surgery. However, in emergency situations it is often not possible to know whether a patient     has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to     determine if there is content in a patient's stomach and how much. This test involves an     ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.      The purpose of this study is to determine how accurate these measurements are. In other     words, how good are we at detecting an empty stomach from one that has liquids, or solids in     it. You are being asked to participate in this study because we require non-pregnant     volunteers in order to answer the aforementioned study question.   "
53244|NCT02588651|"     This study will include patients with mature T-cell lymphoma (MTCL) that has been treated     with at least one type of chemotherapy, but is not responding or coming back after the     previous treatment.      This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration     (FDA) has approved Brentuximab Vedotin for sale in the United States for certain diseases.     Brentuximab is still being studied in clinical trials like this one to learn more about what     its side effects are and whether or not it is effective in the disease or condition being     studied.      Brentuximab Vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually     have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the     chemotherapy). Antibodies are proteins that are part of your immune system. They can stick to     and attack specific targets on cells. The antibody part of Brentuximab Vedotin sticks to a     target called CD30. CD30 is an important molecule on some cancer cells (including non Hodgkin     lymphoma) and some normal cells of the immune system. The cell killing part of Brentuximab     Vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the     antibody part of Brentuximab Vedotin sticks to. Brentuximab Vedotin has also been shown to     kill cancer cells with levels of CD30 that cannot be seen by traditional methods.      This study is being done to test if the study drug has an effect on Mature T cell Lymphoma     with such low levels of a target called CD30 and how your disease respond to the study drug.   "
53245|NCT02588638|"     In the study, NextGen SE are on-hand a cohort comprising each 50 pediatric and 50 adult     patients, and in which there are an unclear movement disorder or an unclear cognitive     disorder, examines the following questions :      Primary:        -  Number of diagnoses made by NGS      Secondary:        1. restriction of the quality of life by unclear disease        2. Cost of not purposeful preliminary diagnostics ( beyond the minimal diagnostic data set          )        3. Impact of the diagnosis to therapy and follow-up examinations        4. Time to diagnosis   "
53246|NCT02588625|"     This is a two part study.      The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse     cutaneous systemic sclerosis using one dose of BMS-986020.      The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse     cutaneous systemic sclerosis using two different doses of BMS-986020.   "
53247|NCT02588612|"     This study is intended for men and women at least 18 years of age who have advanced lung     cancer which has grown or returned after being treated. In particular, it is a study for     subjects who have a blood test positive for HLA-A*0201, HLA-A*205 and/or HLA-A*0206 protein     and a tumor test positive for NY-ESO-1 expression (protein or gene). The study will take the     subject's T cells, which are a natural type of immune cell in the blood, and send them to a     laboratory to be modified. The changed T cells used in this study will be the subject's own T     cells that have been genetically changed with the aim of attacking and destroying cancer     cells.      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back     to the subject through an intravenous infusion. The purpose of this study is to test the     safety of genetically changed T cells and find out what effects, if any, they have in     subjects with lung cancer.      Subjects will be seen frequently by the Study Physician right after receiving their T cells     back. Subjects will then be entered into a long-term follow up in order to monitor the     subject. Subjects will be seen every 6 months by their Study Physician for the first 5 years     after the T cell infusion. If the T cells are found in the blood at five years, then the     subjects will continue to be seen once a year until the T cells are no longer found in the     blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years,     then the subject will be contacted by the Study Physician for the next 10 years.   "
53248|NCT02588599|"     The purpose of this study is to determine whether low level laser therapy (LLLT) using the     Erchonia LUNULA device is effective in increasing clear nail in toenails with onychomycosis.   "
53249|NCT02588586|"     This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying     rebound of viral load during a brief treatment interruption of standard ART, and its safety     during a brief analytical interruption of antiretroviral therapy.   "
53250|NCT02588573|"     The objective of the study is to compare the overall subjective comfort profile over 8 hours     of lens wear in two groups of habitual soft contact lens wearers (frequent replacement and     daily disposable hydrogel lenses) when refitted into Clariti 1-Day.   "
53251|NCT02588560|"     In last few years, most researches about hepatic complication after chemotherapy focused on     hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares     can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are     traditionally considered as relative safe to receive chemotherapy. However, two large     retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma     patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to     predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to the     lack of prospective studies, the dynamic changes of serum HCV RNA levels and the association     of hepatitis are still unclear.      Some epidemiologic studies demonstrated an association between HCV infection and B-cell     lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several     reports showed higher prevalence of HCV infection among DLBCL patients than the controls. HCV     infected DLBCL patients are reported to have distinct clinical characteristics, such as     older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the     impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area     of HCV but there are limited reports addressing the clinical characteristics and prognosis in     this unique population.      Therefore, the investigators initiate a prospective, multi-center observational study to     clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected     lymphoma patients treated with chemotherapy.   "
53252|NCT02588547|"     This study compares the efficacy of two different doses of intravenous (IV) granisetron on     the prevention of postspinal shivering during cesarean section, in comparison with IV     pethidine and placebo.   "
53253|NCT02588534|"     A single-center, open-label, randomized study with a screening period of up to 21 days.     Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the     thigh to compare injection by auto-injection device to manual injection (each injection     separated by 28 days)   "
73149|NCT02328313|"     To determine if exercise will affect the increase in p16 expression that is associated with     both chemotherapy administration and advancing age.   "
53264|NCT02588391|"     The purpose of this study is to determine if different forms of child-friendly,     computer-based puzzles and games (brain training) targeting executive function (EF) skills     (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk     for EF problems due to premature birth. The investigators hypothesize that children receiving     active brain training will show greater improvements in EF and related skills immediately     after treatment than children receiving passive brain training. The investigators are also     interested in whether any improvements in EF and related skills occur or are maintained at 3     and 6 months after completion of brain training.   "
53265|NCT02588378|"     This prospective, non-therapeutic study will compare the relative utility of multiple ocular     imaging modalities in the detection of the cellular immune response in patients with AMD and     related disorders.   "
53266|NCT02588365|"     The purpose of this study is to determine if different forms of child-friendly,     computer-based puzzles and games (brain training) targeting executive function (EF) skills     (i.e., thinking, problem-solving) result in improvements in EF in preschool children with or     at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and EF problems. The     investigators hypothesize that children receiving active brain training will show greater     improvements in EF and related skills immediately after treatment than children receiving     passive brain training. The investigators are also interested in whether any improvements     in EF and related skills occur or are maintained at 3 and 6 months after completion of brain     training.   "
53267|NCT02588352|"     The current prospective cross-sectional pilot study is proposed to determine a set of     characteristic factors associated with salt sensitivity in young adults by measuring blood     pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central     arterial pressure in response to short term increases in salt intake.   "
53268|NCT02588339|"     This study will test PANO in combination with tacrolimus/sirolimus (TAC/SIR) for acute GVHD     prevention. The purpose of this study is to determine if Panobinostat (PANO) when used in     combination with sirolimus and tacrolimus will help reduce the incidence of Graft-vs-host     disease (GVHD).   "
53270|NCT02588313|"     Aim of the study is to investigate long-term effects of CarelessTM, a Mangifera indica fruit     powder on microcirculation and endothelial function after supplementation of 4 weeks. Effects     will be investigated with 100mg and 300mg CarelessTM and compared to placebo.   "
53287|NCT02588092|"     This study evaluates ADCT-301 in patients with Acute Myeloid Leukemia (AML) or Acute     Lymphoblastic Leukemia (ALL). Patients will participate in a dose-escalation phase (Part 1)     and receive ADCT-301 either weekly or once every 3 weeks.      In Part 2 of the study, patients will receive a recommended dose of ADCT-301 as determined by     a Dose Escalation Steering Committee.   "
53271|NCT02588300|"     This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE).     The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea     hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography.      This study correlates the sedation level measured by entropy during DISE using propofol via a     TCI pump with the local obstruction patterns of the upper airway according to the VOTE     classification.      As OSAHS is a widespread disease and the DISE procedure has become a common tool for     diagnosis and evaluation of further treatment, a growing number of research articles deal     with this topic. These articles are available through pubmed.   "
53272|NCT02588287|"     This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the     pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based     antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r)     and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate.     The study consists of three visits: a screening visit and two abbreviated 4-hour     pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks     after initiating SOF/LDV).   "
53273|NCT02588274|"     Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide.     So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators     design and implement this study is to assess efficacy of acupuncture therapy performed in the     CP/CPPS .   "
53274|NCT02588261|"     The purpose of the study is to evaluate the progression free survival (PFS), based on     independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in     patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma     non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating     mutations.      This study will also assess Overall survival (OS); Overall response rate (ORR) as assessed by     IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR;     Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and     patient-reported outcome (PRO) parameters.   "
53275|NCT02588248|"     The primary objective of this double-blinded, prospective, randomized placebo-controlled     study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of     peppermint oil solution vs placebo application during colonoscopy. The investigators     hypothesize that ADR will be increased with the use of the peppermint oil solution and thus     further reduce the risk of colon cancer by means of colonoscopy.   "
53276|NCT02588235|"     After successful coronary angiography and OCT examination, patients with TCFAs in     non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly     assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20     mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be     scheduled for the target vessel after 12 months.   "
53277|NCT02588222|"     The purpose of this study is to establish reliable reference intervals for fecal S100A12 in     healthy children.   "
53278|NCT02588209|"     This study will provide cognitive screenings for seniors age 50 and older. It will also     investigate the benefits of two different cognitive training programs for seniors who have     lower baseline performance on memory and/or gist reasoning tests.   "
53279|NCT02588196|"     The study aimed to evaluate the relationships between the gene polymorphisms of leukotriene     A4 hydrolase(LTA4H) and Dexamethasone treatment for tuberculous meningitis in Chinese     patients.   "
53311|NCT02587780|"     This observational study is designed to examine the glycaemic responses (of sedentary, active     and very active healthy individuals) to a 50gram dose of glucose.   "
53280|NCT02588183|"     The COR advance study is a non-randomized prospective single center study to assess the     results of an electrophysiologically guided approach for PV cryoablation using the Arctic     Front Advance ST® catheter together with the Achieve® mapping catheter in 25 patients with     drug-refractory paroxysmal AF.      Methods Patient selection criteria will be the same that in the original COR study. All     patients will be followed with a Reveal LINQ® cardiac monitor that will be implanted before     ablation. The primary objective is the proportion of patients remaining free from atrial     fibrillation recurrences without taking antiarrhythmic drugs 12 months after ablation.     Secondary objectives are: AF-free survival without anti arrhythmic drugs 12 months after     ablation, cumulative AF burden (number of AF episodes and percentage of time in AF) 12 months     after ablation, percentage of the pulmonary veins with bidirectional block at the end of the     procedure, and ablation time (from the onset of the first energy delivery to the end of the     last energy delivery), procedure time (from femoral puncture to catheter removal), and     fluoroscopy time.      Final results will be known 24 months after the first enrollment. Statistical analysis     Continuous variables that are distributed normally according to the Shapiro-Wilk test will be     presented as the mean [standard deviation], and the values will be compared with the t test.     Continuous variables that do not follow a normal distribution will be presented as the median     [25th to 75th percentile] and will be compared with the Mann-Whitney U test. Categorical     variables between two groups with expected values <5 will be compared with the Fisher exact     test. Otherwise, categorical variables will be compared with the chi-squared test. The     AF-free survival functions will be represented as Kaplan-Meier curves. Data analyses will be     done with JMP® (version 9.0.1, SAS Institute Inc., Cary, NC, USA) and Stata® (version 11.0,     StataCorp LP; College Station, TX, USA).   "
53281|NCT02588170|"     A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the     efficacy of Sulfatinib 300 mg once a day in treating advanced extrapancreatic neuroendocrine     tumors.   "
53282|NCT02588157|"     Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the     intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.   "
53283|NCT02588144|"     54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic     nucleus stimulation and dopaminergic medication will be included into this multicentre     randomised controlled double-blinded parallel group clinical trial. The treatment consists of     two different stimulation settings using (i) conventional stimulation of the subthalamic     nucleus [standard STN] as active comparator and (ii) combined stimulation of active electrode     contacts located in both the subthalamic nucleus and substantia nigra pars reticulata     [STN+SNr].   "
53284|NCT02588131|"     This phase 2, open-label, single arm study aims to evaluate the efficacy of tremelimumab in     combination with the anti-PD-L1 MEDI4736 in patients with unresectable malignant mesothelioma     subjects   "
53285|NCT02588118|"     In recent years it has become clear that gender differences exist both in the     pharmacokinetics and the pharmacodynamics of drugs related to the practice of anesthesia.     Differences in pharmacokinetics are more straightforward to study than differences in     clinical effects. However, isolated pharmacokinetic data are of less value if they are not     accompanied by measurements of clinical effects. Males are more sensitive than females to     propofol. It may therefore be necessary to decrease the propofol dose by 30-40% in males.     Females have 20-30% greater sensitivity to the muscle relaxant effects.   "
53289|NCT02588066|"     To investigate, whether a prophylactic wrapping of the gastroduodenal artery stump with the     ligamentum teres or falciform hepatic (embryological structures, covered with peritoneum that     do not have relevant meaning for adults) can reduce the incidence of arrosion bleeding during     surgery.      Thus a surgical technique is evaluated prospectively.   "
53291|NCT02588040|"     The objective of the study is to further characterize the performance of L-PRP prepared using     the Biomet Recover Kit in the treatment of chronic LE. The study will explore the potential     impact of patient demographics and baseline characteristics on treatment outcome. Furthermore     it will track and document treatment effects, time course, and untoward effects following     treatment of chronic LE with L-PRP from the Recover device. In addition, the utilization of     healthcare resources and associated costs will be investigated in treated patients.   "
53292|NCT02588027|"     This will be a randomized controlled trial to determine if postoperative ibuprofen after     arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog     Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.   "
53293|NCT02588014|"     The purpose of this project is to examine potential mechanisms that may underlie early visual     and auditory perception as well as visual and auditory affect perception deficits in     schizophrenia and the possible connection between these processes. Given that affect     perception largely involves visual and/or auditory information processing and likely relies     on intact basic visual and/or auditory perceptual mechanisms, the investigators will examine     affect perception deficits within the framework of the more basic visual and auditory     processes. Specifically, the investigators will examine magnetophysiological correlates of     vocal and visual affect discrimination, non-affective face discrimination and voice     discrimination, and simple visual and auditory stimulus discrimination, using     Magnetoencephalography (MEG), to identify neural mechanisms underlying perceptual deficits,     as well as their contribution to affect perception deficits in schizophrenia.   "
53294|NCT02588001|"     The purpose of this study is to investigate the efficacy and safety of enzalutamide in     patients with non-metastatic castration resistant prostate cancer. The total duration of the     study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules)     orally once daily. The treatment will be started at Visit 0 within one week after enrollment.     Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on     adverse events and the Japanese version of the Functional Assessment of Cancer     Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the     investigator can continue the treatment with 12-week cycle visit (counted from initial dose)     until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after     enrollment and at 3 years after the last participant enrollment. The end of the study is     defined as follow-up assessment date at 3 years after the last participant enrollment.     Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free     survival (PFS).   "
53295|NCT02587988|"     Trial to Evaluate the Efficacy and Safety of HCP1302   "
53296|NCT02587975|"     This study is designed to measure the effect of evogliptin on bone metabolism in healthy     volunteers.   "
53298|NCT02587949|"     In patients admitted to hospital with acute cerebrovascular stroke, we want to study the     relationship between hair cortisol levels and biomarkers of inflammation and the clinical and     radiological severity of the stroke and the degree of neurological disability being tested in     three months and one year after.   "
53299|NCT02587936|"     ICD-Pieces (Parkland Intelligent e-Coordination and Evaluation System) trial is a National     Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to     improve management of patients with a triad of Chronic Kidney Disease, hypertension and     diabetes with Pieces in four HCS including Parkland, Texas Health Resources (THR), ProHealth     Physicians Incorporation and North Texas VA. Pieces is a decision support technology platform     created by Parkland Center for Clinical Innovation(PCCI).      The primary objective is to test the hypothesis that a collaborative model of primary care     and subspecialty care intervention enhanced by Pieces and practice facilitators compared to     standard clinical practice will reduce all-cause hospitalizations in patients with coexisting     chronic kidney disease, diabetes and hypertension.      Secondary objectives are: a)Test if implementation of the collaborative model will reduce     30-day readmissions, emergency room visits, cardiovascular events or deaths and     disease-specific hospitalizations; b) Develop and validate risk predictive models for     disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions, emergency     room visits, cardiovascular events and deaths for patients with chronic kidney disease,     diabetes and hypertension. c) Collect demographic and clinical data to assist phenotyping     patients with chronic kidney disease, diabetes and hypertension. d) Obtain safety data     including Acute Kidney Injury, progression of chronic kidney disease, electrolyte     disturbances and medication errors, and drug toxicity; e) Collect resource utilization     information including hospitalizations, emergency room visits, outpatient visits, and     diagnostic or therapeutic procedures completed.      Candidate patients in selected clinics will be enrolled over a period of 2 years and followed     for 12 months. Pieces will ascertain both primary and secondary outcomes from the Electronic     Health Record supported with data from the Dallas Fort Worth Hospital Council (DFWHC),     Accountable Care Organization (ACO) reports and VA database, and deaths from Social Security     Index (SSI) data.   "
53300|NCT02587923|"     Background: Accurate diagnosis of small gastric subepithelial tumors (SETs) is essential in     order to assess their malignant potential. Endoscopic unroofing by conventional snare or     needle knife has been reported to yield sufficient tissue samples for histological evaluation     including immunohistochemical staining.      Aims: The investigators aim to evaluate endoscopic unroofing in patients with small gastric     SETs regarding its safety and diagnostic accuracy as well as a potential therapeutic effect     of this technique over time.      Methods: In the context of a retrospective analysis, the investigators will identify patients     who underwent endoscopic unroofing of small SETs of the stomach at the Medical University of     Vienna. Demographic data, indication for intervention, safety of the procedure and follow‐up     will be assessed.   "
53301|NCT02587910|"     Melanole, a Nigella sativa (Black Seed) extract , is studied for the treatment of GERD.     Participants, who meet the inclusion criteria, will be divided into two arms.      Arm 1: Subjects who meet criteria for GERD will undergo 24 hour pH monitoring.      Arm 2: Subjects who meet criteria for GERD and who undergo only symptomatic monitoring of     GERD on treatment.      All participants will be evaluated before and after the administration of the study product.   "
53302|NCT02587897|"     Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal     disorder, impacting 10 million people annually and costing employers up to $113,695 per     incident. There is currently no established method to detect this disorder prior to the onset     of symptoms and nerve damage. Preliminary research suggests that sonography—a relatively     inexpensive, widely available, increasingly portable technology—can provide a non-invasive     and pain-free method of early detection that could reduce incidence, improve targeted     interventions and ultimately reduce costs. The primary aims of this study are to establish     predictive validity of a novel method for early detection using sonographic imaging and to     identify task components of intensive functional hand activity associated with morphologic     changes.   "
53303|NCT02587884|"     The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on     the prognosis of patients with microvascular invasion presence(MVI) and overexpression of     Aspartate-β-hydroxylase(ASPH).   "
53304|NCT02587871|"     This phase II trial studies how well donor cellular therapy after cytarabine works in     treating patients with intermediate-risk acute myeloid leukemia with a decrease in or     disappearance of signs and symptoms of cancer. Donor cellular therapy is a short-term     transfusion of cells from a family member who is incompletely matched. The use of these     partially matched white blood cells may help improve response to standard chemotherapy     (cytarabine) and reduce some of the risks of infection, without a permanent transplant. Drugs     used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving donor cellular therapy after cytarabine may kill more cancer cells.   "
53305|NCT02587858|"     The purpose of this study is to learn more about a subtype of Neurodegeneration with Brain     Iron Accumulation (NBIA) called Pantothenate Kinase-Associated Neurodegeneration (PKAN) by     (1) collecting information about how symptoms and findings in NBIA change over time and (2)     identifying measures of NBIA that can be used in future clinical trials. Participants will     logon to a secure website from home every 6 months for a period of 5 years to electronically     complete a set of rating scales as related to their NBIA.   "
53306|NCT02587845|"     Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients     undergoing total hip arthroplasty. However, no to date, no study has been large enough to     determine definitively whether the drug is safe and effective. The present study was designed     to verify noninferior efficacy and safety of topical intra-articular TXA compared with     intravenous TXA in primary THA.   "
53307|NCT02587832|"     To compare the primary outcome, failure of extubation defined by the need for re-intubation     and mechanical ventilation within 5 days of initial extubation and secondary outcomes,     morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and     Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for     preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.   "
53308|NCT02587819|"     This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and     tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.   "
53309|NCT02587806|"     STUDY OBJECTIVES:      Primary Objective: Assessment of treatment safety based on incidence of any treatment     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months     post treatment.      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and     gadolinium-enhanced magnetic resonance imaging (MRI).   "
53310|NCT02587793|"     The aim of this project is to investigate whether the proliferative speeds of cultured cells     using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging     classification for the possibility of personalized treatment and prediction the outcomes in     hepatocellular carcinoma (HCC) patients.   "
53316|NCT02587715|"     STUDY OBJECTIVES:      Primary Objective: Assessment of treatment safety based on incidence of any treatment     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months     post treatment.      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and     gadolinium-enhanced magnetic resonance imaging (MRI)   "
53317|NCT02587702|"     The purpose of this study is to determine whether different content of β-palmitate will cause     significant differences on Fatty Acids and Mineral Metabolism in Infants   "
53318|NCT02587689|"     The purpose of this study is to determine whether autologous T cells bearing chimeric antigen     receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for patients     with relapsed or refractory solid tumor.   "
53319|NCT02587676|"     Thirty complete maxillary denture wearers were recruited after obtaining informed consent.     One investigator measured the Shore D hardness of the commercially available RDLs using a     Vesmeter®. The salivary flow rates and pH values and the occlusal force were measured for all     patients before initiation of the study.      T-tests and Pearson's correlation coefficients were used for statistical analyses.      A p-value of <0.05 was considered statistically significant.   "
53320|NCT02587663|"     This clinical trial studies mammography and targeted ultrasound with or without whole-breast     ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of     disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging     procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how     far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound     are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in     finding out how far breast cancer has spread.   "
53321|NCT02587650|"     This is a phase II multi-center prospective basket trial designed to test the hypothesis that     targeting specific kinase fusions in metastatic melanoma with pre-specified kinase inhibitors     will result in objective tumor shrinkage and durable response. The study design is a 2 stage     optimal design with a sample size of N=35, with n1=11 during stage I and n2=24 during stage     II. If 1 or fewer responses are observed during stage I, the trial will be stopped. If 6 or     fewer responses are observed by the end of stage II, the trial will be stopped.   "
53322|NCT02587637|"     The purpose of this prospective post market observational pilot study is to evaluate the     effect of DRG stimulation in the management of chronic discogenic pain in subjects who are     refractory to other available treatments. Selected subjects will not be suitable candidates     for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as     routinely utilised in the study centre. Results from this pilot study will inform current     clinical practice and future comparative studies in this specific population.   "
53323|NCT02587624|"     Prospective observational single center trial, evaluating the safety, radiation exposure and     efficacy of remote magnetic catheter ablation for atrial fibrillation in daily routine.   "
53324|NCT02587611|"     The purpose of this study is to compare the effect of either elemental liquid diet or     standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients     receiving gastrostomy feeding.   "
53325|NCT02587598|"     This is an open-label, dose-escalation study of the proviral integration site of Moloney     murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced     malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation)     will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and     the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken     forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will     further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of     the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of     INCB053914 in combination with select standard of care (SOC) agents and will identify the     optimal INCB053914 dose in combination with conventional SOC regimens to take forward into     Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and     pharmacokinetics of the recommended Phase 2 dose combination(s).   "
53326|NCT02587585|"     The amount of activity completed by individuals within rehabilitation programs, even when     units are well staffed, is often far below that required for optimal stroke rehabilitation,     and is not individually adapted on a day-to-day basis. Daily feedback on their activity     levels may motivate stroke survivors to engage in greater skills practice and thus outcome     after stroke. To date only a few trials suggests that augmented feedback may be effective.     There is a need for a large pragmatic trial to explore the impact of augmented activity     feedback on top of their standard care. The purpose of this study is to determine the effect     of augmented activity feedback by smart watches to support in-patient stroke rehabilitation.   "
53327|NCT02587572|"     This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the     safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic     syndrome and to assess the effects of LMSCs on endothelial function using several different     doses.   "
53328|NCT02587559|"     Approximately 60 subjects from a sample of convenience diagnosed with shoulder arthritis will     be randomized into a two groups. The control group will receive usual medical advice and the     experimental group will be referred to physical therapy for eight visits over 4-week period     of time. At one month, two months, and one year the pain, function, and patient satisfaction     will be compared between the two groups.   "
53329|NCT02587546|"     The purpose of the study is to compare results of the treatment of tumorous and non-tumorous     laryngotracheal stenosis using thulium contact laser versus carbon dioxide laser used in the     past.   "
53383|NCT02586831|"     To assess whether there is a difference in endogenous insulin secretion, measured as     stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance     test), at the 1 year visit, for study subjects receiving combinational therapy versus those     receiving placebo. The study will also examine the effect of the proposed treatments on     immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.   "
53330|NCT02587533|"     Peripheral chemoreceptors and baroreceptors are located in close proximity in the carotid     artery wall at the level of the carotid bifurcation. Baroreceptor stimulation lowers     sympathetic activity and blood pressure. In contrast, chemoreceptor stimulation raises     sympathetic activity and blood pressure. Thus, beneficial effects of electrical carotid sinus     stimulation on blood pressure could be diminished by chemoreceptor overactivity and/or     concomitant chemoreceptor activation through the device. Therefore, our study will assess     baroreflex/chemoreflex interactions in patients with resistant hypertension equipped with     carotid sinus stimulators. The study will inform us of potential additional anti-hypertensive     benefits of simultaneous chemoreceptor denervation during electrode placement. Furthermore,     the results may provide information about suitable electrode design to spare co-activation of     peripheral chemoreceptors. Taken together, the study will help develop strategies for     improving responder rate and efficacy of carotid sinus stimulators in patients with resistant     hypertension.   "
53331|NCT02587520|"     This is a dose and formulation ranging study to assess the safety and immunogenicity of     SP0173 in healthy adolescents, adults, and older adults in the US.      Primary Objective        -  To describe the safety profile of each SP0173 investigational formulation.      Observational Objective:        -  To describe the immunogenicity of each SP0173 investigational formulation.   "
67858|NCT02397525|"     Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients     who have central abdominal bulging. Efficacy measurements will also be collected.   "
53332|NCT02587507|"     A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in     peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange     juice, when consumed together with the high-fat meal, is able to revert the increase in     inflammatory markers. The present study will assess the effect of a single HFHC meal taken     with water, orange juice or an isocaloric glucose drink on protein expression in peripheral     blood mononuclear cells of healthy individuals. Twelve healthy, normal weight individuals     consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design     with at least one week interval between the meals. Blood samples were collected before, 1, 3     and 5h after the meals.   "
53333|NCT02587494|"     This is a pilot study that will lead to a large randomized control trial (RCT), to assess     whether early versus late or no cardiac catheterization is associated with improved outcomes     in out-of-hospital cardiac arrest (OHCA) patients.   "
53334|NCT02587481|"     In this open, monocentric, observational study acute coronary syndrom (ACS) patients will be     characterized by pneumological examination concerning a concomitant chronic obstructive     pulmonary disease (COPD). Often COPD coexists with ACS; therefore ACS patients benefit either     from prevention or potential therapy of chronic hypoxia.   "
53335|NCT02587468|"     GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific     vitamins from encapsulated Juice Plus+® powder      ENDPOINTS        -  Absorption kinetics of phenolic compounds in plasma        -  Bioavailability of vitamins C, E, and carotenoids into plasma      Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see     underneath).   "
53336|NCT02587455|"     Lung cancer is the second most common cancer in the UK with around 43,500 new patients     diagnosed each year. About 69% of patients are diagnosed with advanced stage disease and at     present these patients would be expected to survive for less than 12 months. These statistics     therefore show the need for the development of new effective drugs in the treatment of     advanced Lung cancer.      Recent trial results have shown the efficacy of immunotherapy in treating several types of     tumours including lung cancer. These tumours are known to express a high level of a     glycoprotein called PDL1 which is a component of the PD1 pathway. In cancer the PD1 pathway     can be hijacked by tumours leading to the immune system being suppressed. The aim of the new     drug Pembrolizumab is to restart the PD1 pathway and use the immune system to help fight the     cancer cells. Radiotherapy has also been shown to cause cancer to increase production of the     proteins that can block the immune system. Therefore it has been proposed that combine of new     immunotherapy agent such as pembrolizumab and radiotherapy in the treatment of lung cancer     will allow more cancer cells to be killed through the immune system.      The purpose of this study is to see if pembrolizumab can safety be combined with standard     palliative radiotherapy in patients with lung cancer. In addition once the patients have     completed their course of radiotherapy they will remain on pembrolizumab alone and the study     will look at how well this treatment regimen can control the growth of the cancer.   "
53337|NCT02587442|"     This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study     designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This     study is to be conducted at two clinical centers and in conformity with Good Clinical     Practice (GCP).   "
53338|NCT02587429|"     The aim of this study is to investigate, whether a patient education with focus on pain     coping is able to improve physical function and experienced pain level in patients with high     levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that     these patients do not achieve a satisfactory pain relief and physical function after TKA.     Furthermore, the aim is to determine if there is a difference in physical activity and muscle     mass among patients with high levels of pain catastrophizing compared to patients with low     levels of pain catastrophizing.   "
53339|NCT02587416|"     The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of     atorvastatin 80 mg   "
53340|NCT02587403|"     The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus     Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral     hernia repair and assess post-operative complication rates, long term hernia recurrence     rates.   "
53341|NCT02587390|"     The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of     simvastatin 80 mg.   "
53384|NCT02586818|"     This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR     system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR     using a laboratory reference instrument and reagent (Sysmex/Innovin) calibrated to the WHO     rTF09 reference standard.   "
53385|NCT02586805|"     This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to     evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in     patients with Type I and Type II HAE.   "
53342|NCT02587377|"     The availability of sensitive and specific fungal biomarkers could be a precious help to     improve the management of patients suffering from fungal diseases, not only by allowing     preemptive treatment, but also by offering objective elements to assess patient therapeutic     response and prognosis.      The use of such biomarkers could also contribute to accurately evaluate novel antifungal     drugs effectiveness and to serve as a valuable tool to guide decisions regarding ineffective     treatments and dose selection in product development. Using two or three tests may increase     the sensitivity to detect IFI.      The results of the serum assays will be correlated to the definition of 'proven' fungal     infection as defined by the EORTC/MSG criteria published in 2008. Based upon results from     adults' studies, the investigators estimate that galactomannan antigen or 1, 3 β-D glucan     could reasonably have a 90% sensitivity (with a 95% CI between 73% and 98%) under the current     design. As concern the aspergillus fumigatus PCR, sensitivity and specificity could be     estimated between 63% to 100% and 87% to 96.7%, respectively.   "
53343|NCT02587364|"     The purpose of this study is to evaluate the multiple‐dose pharmacokinetic characteristics     and pharmacologic activity of gemcabene.   "
53344|NCT02587351|"     This is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that     will enroll 1028 patients with at least moderately severe COPD over a three year period and     follow them at regular intervals for one year. The primary endpoint is time to first acute     exacerbation. Secondary endpoints include rates and severity of COPD exacerbations,     cardiovascular events, all-cause mortality, lung function, dyspnea, quality of life and     metoprolol-related side effects.   "
53345|NCT02587338|"     This study investigates the beneficial effects of prefrontal brain stimulation (with     transcranial direct current stimulation [tDCS]) during working memory training in seniors     with subjective memory impairments.The placebo-controlled double blinded study includes 50     elderly probants which were randomized into verum or sham tDCS.   "
53347|NCT02587312|"     The purpose of this study is to determine how reducing the level of nicotine in cigarettes     may affect adolescent smoking behavior. In this study, the researchers will randomize     adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine     content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline     period. Participants will be instructed to smoke only those cigarettes. The researchers will     conduct daily assessments of total cigarette use (both study cigarette and non-compliant use     of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon     monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes     and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and     toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect     real-world smoking behavior in adolescents, and illuminate the potential mechanisms through     which these products may effect such changes. Such knowledge will contribute to the science     base that may inform future policy decisions.   "
53348|NCT02587286|"     The purpose of this trial is to explore the impact of the Gather Health diabetes management     platform diabetics' health behaviors and health outcomes and how providers and diabetics     interact with the Gather Health platform.   "
53349|NCT02587273|"     This study is part of a project intended to develop guidelines to optimise the dosing of     fentanyl in intensive care patients.      This study will focus on determining:        -  Whether the pharmacokinetics of fentanyl change during the ICU stay.        -  To what extent / the degree of change in fentanyl pharmacokinetics in ICU patients.        -  Which factors (e.g. physiological variables) that cause such a change.        -  Based on simulations, determine context-sensitive half-times of fentanyl in ICU          patients.   "
53350|NCT02587260|"     The purpose of this randomized, cross-over study, is to ascertain if ticagrelor, but not     prasugrel or clopidogrel, is associated to an improved endothelial function as assessed with     peripheral arterial tonometry and markers of endothelial function measurement in post-ACS     patients.   "
53351|NCT02587247|"     Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific     anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging     potential candidate patients for surgery of local resection of one or more metastases at     diagnosis or during relapse CCR expressing CEA.   "
53352|NCT02587234|"     The investigators proposed to evaluate the effectiveness of sustained peripheral nerve     stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).   "
53353|NCT02587221|"     A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate     the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine     Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.   "
53354|NCT02587208|"     Outcome of circumcision with Plastibell or conventional dissection techniques in infants and     children: A prospective randomized controlled trial      Aim: to evaluate and compare postoperative and esthetic outcomes after Plastibell and     conventional dissection circumcision      Methods:      Randomized Controlled Trial Inclusion criteria: patients younger than 13 years including     neonates who required circumcision for various indications.      Exclusion criteria: - patients with bleeding or clotting disorders        -  Those whose parents insisted on a particular type of surgery        -  Children with lateral- lateral diameter of the glans over which a Plastibell device          could not be placed Primary endpoint: parental concerns and satisfaction (questionnaire)          Secondary endpoints: composite morbidity, operative time, postoperative pain (analgesic          requirements)        -  Early postoperative problems: infection, bleeding, swelling, dysuria, pain (incidence,          mean duration, emergency care if necessary, parental concerns about them (on a          Likert-type 5-point scale [ not at all, a little, rather, very, very much])        -  Irregular scar, jumbling of tissues at the site of frenulum (assessed by physician)        -  Postoperative adhesions (assessed by physician)        -  Postoperative pain and analgesic requirements (paracetamol 15 mg/kg PO Q6 hrs for 48 hrs          then PRN) number of doses and days required for analgesia as judged by parents, VAS ( >-          6 SCORE ), Kaplan-Meier analysis (time to event)        -  Parental satisfaction ( overall esthetic outcome [ very much satisfied, very satisfied,          rather, a little satisfied, not at all satisfied])        -  Parental satisfaction ( skin removal): excess skin removal, insufficient skin removal [          not at all, a little, rather, very, very much]        -  Time for bell separation (mean +-SD), Kaplan-Meier analysis for different age groups   "
53355|NCT02587195|"     National, multicenter study:      The study consists of 3 periods:        1. A baseline visit to confirm that patient is still in CIS status. All patients will be          clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to          exclude MS patients according to 2010 Mc Donald's criteria.        2. Treatment period with timed evaluations        3. Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and          accelerated elimination procedure. All patients who discontinue the study drug and          according to investgator's decision, will perform the accelerated elimination procedure          and the post- accelerated elimination visits (at 2 and 4 weeks after the end of          treatment (EOT).   "
53357|NCT02587169|"     Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant     treatment in liposarcomas and leiomyosarcomas of retroperitoneum.      The main objective of this study is to improve relapse-free survival (RFS)and overall     survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with     resected sarcoma of retroperitoneum.      Secondary objectives include the analysis of antitumoral activity through response rate     (RECIST and tissular changes), the assessment of positive correlation between biomarkers and     clinical results, the study of long term overall survival, and the analysis of the safety     profile of the nilotinib-adriamycin combination.      The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and     therefore better response results are expected (from 20% as P0 to 40% as P1). The study seeks     to find a positive correlation between biomarkers and clinical results in retroperitoneal     liposarcoma and leiomyosarcoma treated with the mentioned combination.      The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS). The     treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with     resectable retroperitoneal sarcoma. The research comprises a robust translational study as     well as histological and radiological reviews.   "
53358|NCT02587156|"     12 elderly (65-70 years of age) male subjects will be included and complete a double blinded     cross-over study. They will be habituated for 21 days to either low or high protein intake     (below 0.7 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will     switch to the alternate group. At the end of each habituation period, the investigators will     measure the appearance of labelled amino acids from milk proteins.   "
53359|NCT02587143|"     Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of     application. The current investigation aim is to compare the effect of ethyl chloride based     vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry     determinations.      The investigators will conduce a double-blind randomized placebo-controlled trial at     Emergency Department.      We will enroll patients who come to Emergency Department who need an arterial gasometry     determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant     sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo     will be used before arterial puncture.) and after the puncture they will rate their pain     using a 10 points visual analogue scale.   "
53360|NCT02587130|"     Pain is one of the major symptoms in palliative care units and often is very difficult to     treat, being considered as a refractory pain.      There are different causes of refractory pain: pain due to bed sores and ulcer bandages,     carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain     due to traumatological injuries, pain associated with a long-term bed confinement, etc.      The investigators propose a prospective study to estimate the effect and the tolerance to a     subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the     care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care     units.   "
53361|NCT02587117|"     Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous     disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for     the treatment of oral lichen planus. Half of participants (total number of participants was     twenty eight) were received lycopene and the other half were received prednisolone.   "
53362|NCT02587104|"     A single-centered, non-randomized study with approximately 20 subjects that will be seen for     up to 12 weeks, each receiving the EpiFix plus standard of care. Safety and effectiveness     will be monitored throughout the study.   "
53363|NCT02587091|"     A cluster randomized trial was conducted across eight rural sub-counties in southwestern     Uganda. This study was conducted to determine the impact of advertising free obstetric     ultrasound on the attendance to antenatal care clinics.   "
53364|NCT02587078|"     The primary alternative hypothesis is that less time (minutes) is required, to achieve the     initial hemodynamic stabilization, with Volulyte® compared to Jonosteril®.        -  H01: Minutes with Volulyte® ≥ Minutes with Jonosteril®        -  H11: Minutes with Volulyte® < Minutes with Jonosteril®   "
53365|NCT02587065|"     The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the     satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with     injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction     Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are     to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants'     satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants'     adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN     beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on     participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on     participants' injection-system satisfaction; Evaluate the relationship between participants'     satisfaction and adherence; Evaluate the relationship between participants' satisfaction and     social-demographic factors (age, sex, employment working, level of education, etc) and     clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate     the treatment safety and tolerability.   "
53366|NCT02587052|"     This is a retrospective analysis of two different cohorts of patients that has undergone     renal transplantation. This is a matched pair analysis of 100 patients treated with generic     tacrolimus that will be compared with 100 matched controls treated with Prograf. Data will be     obtained from patients' charts, from the Swedish National Kidney Registry and from a local     registry at Transplantationscentrum. Patients included in the study are patients receiving a     first single kidney transplant from a deceased or a living donor, treated with Prograf or     Tacni and transplanted between transplanted January 2012 and August 2014. The 1-year-outcome     of patients following renal transplantation, including BPAR, serious adverse effects and     graft survival will be analysed.   "
53428|NCT02586246|"     The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection     administered for 24 weeks or longer in subjects who are participating in the long-term     treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly     with or without Methotrexate.   "
53435|NCT02586155|"     The purpose of this study is to determine whether bromodomain extraterminal domain (BET)     inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with     coronary artery disease increases the time to major adverse cardiovascular events.   "
53367|NCT02587039|"     Patients that have cardiac surgery may suffer from unrecognized cerebral ischemia or loss of     blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the     brain may result in a condition called delirium. Delirium is a type temporary confusion.     There are some strategies that can help reduce cerebral ischemia during cardiac surgery which     can help lead to a reduction in the incidence of delirium. The investigator believes that a     strategy called remote ischemic preconditioning will help to reduce the incidence of delirium     incidence after cardiac surgery.      Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to     ischemia occurs in an area of the body that is not undergoing a procedure. This brief     exposure to ischemia is not long enough to cause any damage to the body and it has been     demonstrated to help protect against more severe ischemic injury that may occur later during     surgery. In this study the investigator will use remote ischemic preconditioning to see if it     can reduce the incidence delirium after cardiac surgery.   "
53368|NCT02587026|"     This is a tissue collection protocol to create an annotated biorepository to support future     basic and translational research. The study protocol and consent will request patient     permission to allow their specimens to be stored for future use in other     laboratory/correlative studies without requiring a separate new consent at a future date. It     will include also a retrospective review of all patients who have been seen or treated by the     Precision Genomics Clinic (waiver of consent requested). No specific research studies/aims     are included directly in this proposal. Use of the samples, data, and other resources (cell     lines, etc.) created within this protocol will require review/approval by the majority of the     Precision Genomics Investigators and appropriate IRB approval.   "
53369|NCT02587013|"     This study is designed to compare the exteriorization of the uterus versus the in situ repair     for closure of the hysterotomy incision with a completely standardized anesthetic protocol.   "
53370|NCT02587000|"     Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal     acetate) on bleeding control and pain for patients with adenomyosis and wish to keep     fertility.   "
53372|NCT02586974|"     The aim of this study is to assess if the conditioning of the insufflation carbon dioxide     (CO2) allows for an additional benefit in terms of prevention of the heat loss, when compared     with the usual prevention with a forced warm air blanket alone, in the setting of     robot-assisted radical prostatectomy (RARP).   "
53373|NCT02586961|"     The combined administration of high dose of oral betamethasone and nebulization of adrenaline     seems to be an attractive therapeutic alternative for reducing the rate of hospitalization     for acute bronchiolitis treated in the emergency department. However, it is essential to     confirm the trend previously observed with this treatment before using it in current     practice.   "
53374|NCT02586948|"     Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the     respiratory management represents a fundamental challenge for improving prognosis and     reducing mortality. While the hospital mortality of patients treated with NIV has decreased     over years, and is currently less than 10 %, mortality in patients treated with invasive     ventilation remains higher than 25%. To improve the prognosis of patients with acute     exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge     in terms of morbidity and mortality. Among the means available to achieve this goal,     minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.      The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to     limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for     an acute exacerbation, while improving gas exchange.   "
53375|NCT02586935|"     This study will examine the safety and efficacy of tideglusib vs. placebo for the treatment     of core symptom domains in adolescents with Autism Spectrum Disorders   "
53376|NCT02586922|"     The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and     pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and     correlate the results with postnatal respiratory distress of the term neonates.   "
53377|NCT02586909|"     This 12-month open-label study will provide further information regarding the long-term     safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who     have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind     study).   "
53378|NCT02586896|"     This study will compare the effects of brief strengths-based case management (SBCM) to the     effects of screening, assessment and referral alone (SAR) in opioid-dependent patients.     Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per     group) to receive 1) up to 6 sessions of SBCM; or 2) SAR. Follow-up assessments will be     completed at 3 and 6 months, by staff who are blinded to treatment condition.   "
53379|NCT02586883|"     The purpose of this study is to identify the abnormalities of bronchial trans-epithelial     transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the     bronchi.   "
53380|NCT02586870|"     This is a prospective multicenter study based on the validation of diagnostic criteria and     predictive factors of treatment efficacy for renal artery stenosis in renal artery dysplasia.     This is considered as a rare disease and patients are usually treated in specialized centers     involved in a national network. Marseille is a center specialized in FMD and a member of the     network that is very active across the country. In order to rapidly recruit patients the     investigators propose a multicenter study. All patients included will benefit from an     invasive angiography with trans stenotic gradient assessment at rest. In case of bilateral     stenosis the investigators will randomly omit data from one side and consider the data from     the contralateral artery for further analysis, to avoid statistical interdependency. Patients     who require angioplasty and who have unilateral stenosis (unilateral FMD lesion or bilateral     but with one non significant stenosis based on duplex ultrasound European recommendations for     atherosclerotic renal artery stenosis) will be included in the second part of the study.     These patients will in addition benefit from a trans stenotic pressure assessment under     vasodilation and intravascular renal artery ultrasound. Patients with severe bilateral renal     artery stenosis will not be included in the analysis to assess predictive criteria for     treatment efficacy on hypertension, treatment of these patients will followed the current     best clinical practice. These patients will be followed during 6 to 8 month to assess     potential complication of the pressure assessment renal artery stenosis, but their data will     be included to assess the value of FFR and IVUS to guide the procedure. Patients with     unilateral stenosis will be followed up 6 month after angioplasty in order to assess     hypertension and to look for potential complications.   "
53381|NCT02586857|"     A Phase 1b/2, multicenter, open-label study designed to evaluate the efficacy and safety of     ACP-196 in subjects with recurrent GBM who have progressed after 1 or 2 prior systemic     treatment regimens.   "
53382|NCT02586844|"     Prospective study to obtain fresh tumor biopsies and three blood samples from patients with a     confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors     (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs) for molecular     profiling.   "
53386|NCT02586792|"     The study will be an open-label phase 2 clinical trial of a single dose of an inactivated     H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously     participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the     previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28     days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a     1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1)     assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who     previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To     assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9     approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who     previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.   "
53387|NCT02586779|"     Effective communication between consulting physicians and the emergency physicians is     critical for patients in the emergency department. The aim of this study was to determinate     effectiveness of whatsApp usage for communication between physicians.   "
53390|NCT02586740|"     Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for     patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair     for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary     collaterals. Considering that the investigators' institution is a major center for treating     these cases, the investigators wanted to do a retrospective review of the investigators' data     to share the investigators' anesthetic management of these procedures.   "
53391|NCT02586727|"     The primary objective of the study is to assess the safety of intravitreal aflibercept     injection in treating visually compromising radiation maculopathy secondary to treatment of     uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25     patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks.     Subjects in arm 2 will undergo treatment and if improvement is documented at the following     evaluation the next treatment will be extended by two weeks. Secondary objectives of the     study include evaluation and analysis of visual acuity, number of injections, macular edema,     and vascular activity between both arms.   "
53392|NCT02586714|"     This study examined the relationships between maternal body composition, placental function,     and fetal nutrition and body composition, and sought to determine the most accurate method of     maternal body composition analysis in late pregnancy.   "
53393|NCT02586701|"     Investigation into prehabilitation by increasing the supervision of exercise in patients     undergoing colorectal resection for cancer and comparing with patients involved in a     rehabilitation group receiving exercise after surgery.   "
53394|NCT02586688|"     To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham     treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).   "
53395|NCT02586675|"     The purpose of this study is to find out if the investigational drug Ribociclib (LEE011),     when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial     effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer     known as hormone receptor positive/HER2- breast cancer.   "
53396|NCT02586662|"     Background: Patterns of scapular dyskinesis have unique scapular kinematics and associated     muscular activation. The characteristics of scapular dyskinesis may be associated with     functional disability. The investigators investigated whether the level of shoulder function     and primary dysfunction items were different in each unique pattern of scapular dyskinesis.     The factors associated with shoulder dysfunction in different patterns of scapular dyskinesis     were identified.      Methods: Participants with unilateral shoulder pain were classified as having a single     dyskinesis pattern (inferior angle prominence, pattern I; medial border prominence, pattern     II) or a mixed dyskinesis pattern (patterns I+II). Clinical measurements with the Flexilevel     Scale of Shoulder Function (FLEX-SF score), shoulder range of motion, anterior/posterior     shoulder tightness, and pectoralis minor index were recorded. These clinical measurements,     3-D scapular kinematics (electromagnetic-based motion analysis), and associated muscular     activation (electromyography on the upper, middle, and lower parts of the trapezius and     serratus anterior muscles) during arm elevation were analyzed for associations with     functional disability.   "
53397|NCT02586649|"     Respiratory complications are the leading cause of death during the initial year after acute     SCI, and the third leading cause of death thereafter. Complete or partial loss of respiratory     muscle innervations in individuals with cervical and high thoracic injuries leads to     inadequate ventilation and inability to effectively clear secretions, often prompting     supportive ventilation following initial injury. Development of atelactasis, pneumonias and     respiratory failure are the most common respiratory complications observed during the acute     phase of injury. It is well known that a restrictive ventilatory defect, dependent upon the     level and completeness of injury, is apparent in individuals with chronic cervical SCI.     Respiratory functional impairment might be further compromised in these individuals, the     majority of whom share many aspects of obstructive airway physiology commonly associated with     asthma. The asthma-like features that individuals with chronic cervical SCI demonstrate have     been hypothesized to be due to overriding cholinergic airway tone carried by intact vagal     (parasympathetic) nerve fibers arising from the brainstem, whereas sympathetic innervations     is interrupted at the level of the upper thoracic spinal cord. Whether airway narrowing and     AHR in chronic cervical SCI is also related to chronic airway inflammation is unknown,     although it is conceivable that repeated respiratory infections or, possibly, a neurogenic     component, could contribute to chronic airway inflammation.      Therefore, the investigators aim to assess how long-acting bronchodilator (tiotropium     bromide) affects various indices of lung function, including: pulmonary function tests,     levels of inflammation and cough strength across 24 hours after receiving study drug. Results     will be analyzed for baseline, 1 hour, 3 hours, 20 hours and 24 hours post drug inhalation     for both active medication and non-active placebo.   "
53429|NCT02586233|"     This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded,     Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center study     to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of     DS-1040b in subjects with Acute Ischemic Stroke (AIS).   "
53430|NCT02586220|"     Recent studies have found, in both developed and developing countries, there is still a     considerable number of pregnant women in iodine deficiency status.Our overall aim is to     monitor iodine status of pregnant women in China, and to examine the correlation between     maternal urine iodine concentration (UIC) and newborn physical development level.   "
53514|NCT02585115|"     The aim of this study is to determine if sampling technique of urine affects diagnostic     modalities in primary care. Furthermore it aims to determine if there is difference in the     accuracy of the point-of-care test, when the urine sample is stored at room-temperature and     analyzed later in the day.   "
53398|NCT02586636|"     Metformin is the first-line treatment for medical management of Type 2 Diabetes. Up to 25% of     patients experience significant gastrointestinal symptoms and in approximate 5%, side-effects     result in the discontinuation of metformin. It would be of great clinical significance if the     underlying cause of this intolerance was identified.      Recent data has highlighted a metformin transporter in the gut - Organic Cation Transporter     1(OCT1) - as a potential culprit for the variability in metformin tolerance. Across a     diabetic population, up to one in four people were shown to have a single reduced function     allele for OCT1, with approximately 8% having two reduced function alleles. This may increase     the risk of the individual experiencing metformin-associated side-effects, potentially due to     accumulation within the cells lining the intestine. The investigators aim to show that loss     of function of OCT1, either due to genetic variation or drug inhibition of OCT1, may lead to     an increase in the symptoms associated with metformin intolerance.      The study is being undertaken at the Clinical Research Centre in Ninewells Hospital, Dundee.     The investigators will recruit participants from the GoDARTS study (Genetics of Diabetes and     Audit Research Tayside Study). The participants will be healthy controls, i.e. non-diabetic,     and recruited according to their genotype of OCT1 (information from GoDARTS). The volunteers     will then enter a matched cross-over study with two treatment periods. Metformin is taken     during both treatment periods alongside either Omeprazole (a proton pump inhibitor used to     prevent excess stomach acid, known to interact with OCT1) or placebo. The metformin dose is     increased gradually during each period, to a maximum tolerated dose. The investigators expect     to see a lower maximum tolerated dose in individuals with loss of function genotype, or in     those taking concurrent omeprazole compared to placebo. The study will last approximately 9     weeks. Volunteers have 3 visits to the CRC, and weekly phone call interviews.   "
53399|NCT02586623|"     To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD),     Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic     Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously     stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH)     (dizziness, light-headedness, or feelings that they are about to black out)   "
53415|NCT02586415|"     This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical     management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days     when compared to medical management alone in appropriately selected subjects with the Target     mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have     endovascular treatment initiated between 6-16 hours after last seen well.   "
53400|NCT02586610|"     This is a phase II, prospective open label multi-center study in which subjects with stage     II-III rectal cancer will be accrued in order to determine the pathological complete response     rate of neoadjuvant pembrolizumab in combination with chemoradiation treatment (CRT).     Subjects must have a diagnosis of rectal cancer, stage II (T3-4, N0) or stage III (any T,     N1-2). Subjects must have received no prior treatments (chemotherapy, pelvic radiation or     surgery) for their rectal cancer.      Eligible subjects will receive standard chemoradiation with pembrolizumab administered every     3 weeks on days 1, 22, and 43 of the neoadjuvant interval. In all subjects, restaging     endorectal or pelvic MRI with chest and abdominal CT will be performed at 6-8 weeks after     completion of neoadjuvant treatment to determine resectability and to rule out any evidence     of metastases. Subjects who have resectable disease will undergo surgery within 2-4 weeks of     imaging; 8-12 weeks after completion of chemoradiation. Subjects who are found to have     unresectable or metastatic disease post treatment with the combination of CRT+ pembrolizumab     should receive standard of care definitive treatment per the discretion of their treating     physician.   "
53401|NCT02586597|"     Stroke is the third most common cause of death in the United States after heart disease and     cancer, and the leading cause of long-term disability. This work will develop an innovative     brain stimulation method (paired associative stimulation) which might set the stage for a new     treatment for stroke rehabilitation.   "
53402|NCT02586584|"     The purpose of this Canada-France study is to develop and validate a multidimensional     patient-reported measure of perceived barriers to antiretroviral therapy adherence for     HIV-positive patients undergoing treatment that will be theoretically founded, easy to use     and helpful to clinicians in their medical decision-making, in a clinical or research     setting.   "
53403|NCT02586571|"     The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding     among infants who are exclusively and partially breastfed at 6 months of age in terms of     characteristics that are hypothesised to contribute to growth and development of body     composition in infancy.      The scientific originality lies in the simultaneous sampling of multiple factors that are     believed to contribute to growth and development of body composition in infancy, i.e. energy     content of breast-milk, metabolism-regulating hormones in breast-milk, infant temperament and     appetite. The selection of two predefined study groups, i.e. infants exclusively breastfed     until 6 months of age and infants given complementary foods in addition to breast-milk from     3-4 months of age, gives the opportunity to describe, and perhaps up to some point compare,     what now is described by the World Health Organization and in official Icelandic infant     recommendations as optimal feeding and what studies have suggested is common feeding in     many countries. The methods are carefully chosen, i.e. appropriate and non-invasive isotopes     and validated questionnaires are used. To our knowledge, no study has reported breast-milk     composition in exclusively vs. partially breastfed infants.   "
53404|NCT02586558|"     Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of     age or younger. To date, there are no known treatments that have been found to help reduce     colic and its symptoms in babies. The investigators would like to see whether a baby formula     that contains a prebiotic will lead to the same improvements in babies with colic. The     investigators will test this by giving some babies a formula with the prebiotic and other     babies a placebo formula.   "
53405|NCT02586545|"     The aim of the study is to test the effect of a new shared care model for type 2 diabetes     care and compare it with a standardized care management program in a specialized     hospital-based out-patient clinic.      The hypothesis is that participants with type 2 diabetes followed in a shared care program     will have a comparable outcome in HbA1c to participants receiving standard care.   "
53436|NCT02586142|"     Claw toes deformity result in spasticity often seem in patients with central nerve disease.     It also cause pressure sore in foot and pain during walking that didn't well improve under     traditional treatment. There are few relative reports about the Botulinum toxin type A     (BTX-A) injection on claw toe. The investigators' study has two main purposes:        1. assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving          lower extremities function, pain and spasticity in patients with symptomatic claw toes.        2. assess if regular stretching exercise can strength the efficiency of BTX-A injection on          improving lower extremities function, pain and spasticity.   "
53406|NCT02586532|"     Background:      Epstein-Barr virus (EBV) can cause the cancer nasopharyngeal carcinoma (NPC). Early detection     of NPC through screening can lead to better treatment outcomes than when it is found later.     Currently, NPC is found through visual inspection with an endoscope. It is not clear how well     this method works, especially for the identification of small, early cancers. Researchers     want to see how well nasal endoscopy works to detect NPC compared to another method called     magnetic resonance imaging (MRI).      Objectives:      To evaluate the sensitivity of endoscopy to detect prevalent NPC among people who screen     positive for EBV antibodies.      Eligibility:      Participants of the NPC Early Detection Screening Program in China who:      Have increased levels of EBV antibodies      Are otherwise in good health and able to have an MRI procedure      Design:      Participants will be screened with a blood test.      Participants will have a nasal endoscopy.      Participants will have an MRI of the head and neck:      Participants will have lesions identified by either the endoscopy or MRI biopsied and sent to     a pathologist for review and diagnosis of NPC.      Researchers will compare NPC detection rates by endoscopy and by MRI to see which method is     better able to identify prevalent NPC.   "
53407|NCT02586519|"     Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients     with diabetes. While most of these ulcers can be treated successfully on an outpatient basis,     some will persist and become infected. Nearly one fifth of patients with lower-extremity     diabetic ulcers will require amputation of the affected limb, resulting in staggering costs     for both the patient and the healthcare system. Therapies that promote rapid and complete     healing and reduce the need for expensive surgical procedures impact these costs     substantially.      The standard of care for the treatment of diabetic foot ulcers is the removable cast walker     (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as     having compliance issues due to its removable nature. In addressing this limitation, a     modified version of the RCW has been developed by wrapping it in a layer of cohesive or     plaster bandage. This technique has been termed the instant total contact cast (iTCC)     derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While     ease of application and potential clinical equivalence are clear benefits, the iTCC carries     disadvantages on account of its irremovability. For example, frequent dressing changes     impractical, yet may be necessary for complex wound care. The goal of this research is to     continue inquiry and innovation in this most basic aspect of care, whilst addressing the     limitations of past research and failures in this domain.      The investigators propose examining the capability of the SurroSense Rx® smart insole and     smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring     adherence to plantar pressure offloading through alert-based feedback. The insoles are     embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides     feedback on modifying activity or pressure profile over time. This smartwatch transmits     audio, visual, and tactile notifications when excessive pressure-time thresholds under     plantar regions of interest have been met. This feedback allows patients to be educated on     their plantar pressure, and engages them and their caregivers to manage adherence to     offloading. The investigators also propose comparing the healing rates of active neuropathic     ulcers using RCWs coupled with the SurroSense Rx® smart insole system to assess whether     adjunctive use of the two interventions improves the efficiency of neuropathic ulcer     treatment.   "
53408|NCT02586506|"     Asthma is a chronic disease of the lungs characterized by airway inflammation,     bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone     or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a     mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device     is an important consideration because an inadequate technique reduces the delivery of     medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler     that delivers the drug to the lungs effectively, is important. This study is designed to     assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease     of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler     correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2     (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this     multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler     Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used     the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma     therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be     considered eligible to participate in this study. Approximately 252 subjects will be screened     with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA     inhaler use at visit 2.      ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.   "
53409|NCT02586493|"     Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease     characterized by airflow limitation that is not fully reversible. The mainstay for treatment     involves the use of inhaled medications, including short and/or long-acting bronchodilators     along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device     is an important consideration because an inadequate technique reduces the effects of     inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to     the lungs effectively, is important. This study will assess the correct use of the ELLIPTA     inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by     those subjects determined to be using the inhaler correctly. Study will be divided into two     visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day     8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to     receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label,     placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an     established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct     use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this     study. Approximately 252 subjects will be screened with an expectation of 208 subjects     completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.      ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.   "
53410|NCT02586480|"     Observational study on long PR interval using the SafeR mode in bradycardia patients.   "
53431|NCT02586207|"     This is a single-arm, multi-site, open-label trial of pembrolizumab (MK-3475) used in     combination with standard, cisplatin-based, definitive chemoradiotherapy (CRT) in patients     with stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Approximately 39     patients with Stage III-IVB SCCHN will be enrolled to evaluate both the safety and efficacy     of this novel combination. Subjects will not be randomized and will all receive the study     treatment.      Treatment will consist of a loading dose of pembrolizumab 200 mg IV given 7 days prior to     initiation of CRT (day-7). CRT with cisplatin 40 mg/m2 IV weekly and head and neck radiation     at 70 Gy fractionated at 2 Gy once daily over 35 days, will begin on day 1. CRT will end on     approximately day 46-50. Pembrolizumab 200 mg IV will continue following CRT in an adjuvant     fashion starting on day 57 for an additional 5 doses, as tolerated, through day 141. Subjects     will be evaluated for response following treatment.   "
53411|NCT02586467|"     Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the     recommended number of milk and milk product servings (≤2 servings per day). Given the wide     range of health benefits associated with increased dietary intake of milk and milk products     the objectives of this study were to conduct a prospective, 5-arm randomised controlled trial     in order to test the effectiveness of a variety of messages for increasing milk and milk     product consumption in men and women aged 30-50 years old. The five arms consisted of 4     messages that contained slightly different content specifically: 1) gain-framed message     condition, 2) loss-framed message condition, 3) self-regulatory efficacy-enhancing message     condition, 4) gain-framed and self-regulatory efficacy-enhancing message condition and 5)     loss-framed plus self-regulatory efficacy-enhancing message condition. It was hypothesised     that those who receive self-regulatory efficacy-enhancing information would consume more     dairy than those who received messages without such information. Second, those who received     gain-framed messages would consume more dairy as compared to those who received loss-framed     messages. Third, those who received gain-framed messages that include self-regulatory     efficacy-enhancing information would consume the most dairy in comparison to the other four     conditions.   "
53412|NCT02586454|"     Patients who have undergone laparotomies often require multimodal postoperative pain regimes.     In recent years, abdominal wall blocks have been included to become part of this in order to     overcome side effects of systemic opioids and complications from epidural analgesia.      Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular     quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against     somatic and visceral pain as local anaesthetic tends to spread from the site of injection to     thoracic paravertebral spaces where the sympathetic chain lies.      The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block     in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid     consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is     patients given transmuscular QL block will have lower cumulative opioid consumption.   "
53413|NCT02586441|"     The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in     monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic     agents may be associated with a reduction in primary anesthetic use and a reduction in     emergence and recovery time.      However, this equipment does not give the proper anesthetic depth index is a number of     experimental results have been reported.      Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG)     obtained through the depth of anesthesia monitors brain waves to collect statistical data,     through mathematical analysis to analyze the exact correlation between the patient's brain     waves and the depth of anesthesia.   "
53414|NCT02586428|"     Before and after a patient receives genetic counseling they will be offered the chance to     complete the survey, by their counselor. Since each patient sees only one genetic counselor     that counselor will be responsible for consenting and giving and collecting the finish     surveys. No identifiers will be used. The investigators will emphasize that their answers     will remain anonymous throughout the entire process, and that their participation is strictly     voluntary. The patient will be provided with a survey and asked to complete this before their     genetic counseling session and after.The survey will be returned to the genetic counselor and     placed in a locked drawer. Information will also be collected from the medical record     including age, pregnancy history and the reason for the visit.   "
53418|NCT02586376|"     The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More     recently the LLLT was associated with an improvement in the muscle strength and endurance.     But, these effects were described only in health or athletic individuals. In this randomized     and controlled clinical trails, the investigators will study the effects of LLLT on muscle     strength of the patients with kidneys failure on long time hemodialysis treatment.     Additionally, investigators will explore three different intensities up the muscle strength.   "
53419|NCT02586363|"     In this clinical trial, the investigator will clarify the difference in pharmacokinetics     between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high     fatty meal for healthy adult volunteer.      The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.   "
53420|NCT02586350|"     To compare the effects and safety of Anlotinib with placebo in patients with Medullary     Thyroid Carcinoma.   "
53421|NCT02586337|"     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in     patients with Differentiated Thyroid Cancer.   "
53422|NCT02586324|"     In this research, the two media used are Global medium and SSM medium with serum), which are     routinely used in the reproduction biology unit. This study simply consists in setting up a     methodology to compare these to media. The only constraint placed on patients is to accept     randomization for the type of medium used.   "
53423|NCT02586311|"     Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in     Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy   "
53424|NCT02586298|"     The principle objective is to improve embryo quality through autologous micro-injection of     mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a complementary     ICSI technique in patients with low embryo quality in previous IVF cycles and in those who     did not bear children.      This improvement in embryo quality will be determined through on-going pregnancy rate after     treatment and/or improvement in embryo quality according to morphological     (ASEBIR-Association for the study of Biology in Reproductive Science), morphokinetic     criteria and in Preimplantation Genetic Screening.      Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized     in the first part of the study to two treatment groups; standard ICSI procedure without     mitochondrial supplementation and ICSI with autologous mitochondrial supplementation.     Following an interim analysis of outcomes, an additional 130 patients may be added, for a     total of 190 patients.   "
53425|NCT02586285|"     The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after     curative resection of Hepatocellular Carcinoma.   "
53426|NCT02586272|"     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional     study.   "
53427|NCT02586259|"     The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in     routine clinical practice and its effectiveness and tolerability in a real-life setting.   "
53438|NCT02586116|"     This is a post-market, prospective, randomized clinical investigation to evaluate the     performance of the nanOss Cervical Interbody Fusion (IBF) device with nanOss Bioactive Bone     Void Filler for the treatment of cervical disc disease. A secondary objective is to compare     the performance of the nanOss Cervical IBF Device and nanOss Bioactive Bone Void Filler with     the performance of the C-Plus PEEK IBF Device with autograft. This study will enroll 40     patients at one (1) site. After subjects have signed an informed consent, they will be     randomly assigned to either the nanOss Cervical IBF device arm or the C-Plus PEEK IBF Device.     Patients will complete the preoperative visit and examinations. Patients will be evaluated at     discharge, six (6) weeks, three (3) months, six (6) months, and twelve (12) months. Patients     will be evaluated at twenty-four (24) months post-operatively if they have not demonstrated     fusion at the 12 month time point.   "
53439|NCT02586103|"     The mYPAS (Modified Yale Preoperative Anxiety Scale) is a quick, easy, validated and gold     standard assessment tool to measure pediatric anxiety in the perioperative period. Therefore     the objective of the current prospective study is examine if the mY-PAS is an effective     screening tool to differentiate patients who would succeed versus fail for MRI without     sedation/anesthesia.   "
53440|NCT02586090|"     The study will pilot a randomized control trial to investigate the feasibility and     preliminary efficacy of two distinct parent treatments on a dietary intervention for     overweight and obese adolescents.   "
53441|NCT02586077|"     The purpose of this study is to review the use of surgeon applied liposomal release     anesthetic (Exparel) for post operative analgesia.      Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post     operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by     the use of this modality.   "
53442|NCT02586064|"     Interpersonal problems such as relationship conflict and social isolation are common among     Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main     interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing     Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and     many Veterans do not complete these treatments. Couple and family approaches for PTSD address     relationship problems, but logistical problems make it difficult for couples to attend     sessions and these approaches do not involve Veterans who are socially isolated or unmarried.     There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be     effective in reducing symptoms and improving interpersonal functioning. This study, a     randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be     a useful addition to current treatments delivered at the VA.   "
53443|NCT02586051|"     This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered     as intravenous (IV) infusion in adults with end stage renal disease (ESRD). Participants will     be enrolled into two cohorts receiving either one (Cohort 1) or two or more (Cohort 2)     obinutuzumab infusions. Both cohorts will receive standard pretreatments to reduce the risk     of infusion-related reactions (IRRs).      Desensitization Period: In Cohort 1, participants will receive single dose obinutuzumab IV     infusion on Day 1. Following review of Cohort 1 aggregated safety data up to 4 weeks post     dose for the last participant of Cohort 1, Cohort 2 will be allowed to proceed. In Cohort 2,     participants will receive obinutuzumab IV infusion on Days 1 and 15. Transplantation Period:     Participants who qualify for transplantation and receive a compatible kidney offer after     inclusion in Cohort 1 or Cohort 2 will receive two additional infusions (one at the time of     transplantation and second at Week 24 post-transplantation) of obinutuzumab. Assessment of     the safety and tolerability of the obinutuzumab regimen will be conducted at Week 24 of the     desensitization phase and at Week 28 post-transplantation. All participants will be monitored     for a minimum of 12 months following the last obinutuzumab infusion.   "
53444|NCT02586038|"     This study will evaluate the safety and the efficacy of the MLN-DEXAMETHASONE,     MLN-DEXAMETHASONE-CYCLOPHOSPHAMIDE, MLN-DEXAMETHASONE-BENDAMUSTINE or MLN-     THALIDOMIDE-DEXAMETHASONE induction combinations, followed by MLN maintenance in newly     diagnosed elderly Multiple Myeloma patients.      260 patients, males and females, older than 65 years old or younger but considered not     eligible for high-dose chemotherapy and transplantation, enrolled in different sites, will     take part in this study.      The duration of the study is approximately 5 years.   "
53445|NCT02586025|"     This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to     evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab +     placebo + docetaxel in chemotherapy-naïve participants with early-stage or locally advanced     HER2-positive breast cancer. The anticipated treatment duration is approximately 17 months.   "
53446|NCT02586012|"     Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which     promotes blood clotting is missing or does not work properly. Individuals with hemophilia A     are at risk for bleeding. Bleeding is prevented and/or treated with recombinant factor VIII     (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among     patients with hemophilia. Some studies have shown that obese hemophilia patients may be able     to prevent bleeding with a lower dose of clotting factor than the dose they are currently     receiving. The lower dose is calculated based on what a patient should weigh rather than what     he does weigh. This is a clinical research study to test whether calculating rFVIII dosing     based on lean body mass and ideal body weight (what a person should weigh based on his     height) in overweight and obese patients with hemophilia is more accurate than calculating     rFVIII dosing based on what a person actually weighs.   "
53447|NCT02585999|"     Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of     estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The     primary objective is to assess the change in serum ethinyl estradiol (EE2) levels over 12     weeks of continuous contraceptive patch use. The secondary objective is assessing the the     norelgestromin (NGMN) levels over the 12 weeks of continuous contraceptive patch use.   "
53448|NCT02585986|"     The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an     antiinflammatory and modulating activity on immunological processes, with positive results on     different inflammatory and atopic conditions.   "
54354|NCT02574143|"     The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to     provide an estimate of the distribution (prevalence) of NCFB etiologies across all different     levels of health care as well as real-life data regarding the current management of NCFB in     Germany.   "
53449|NCT02585973|"     This open label, single-arm, Phase 1b study is designed to identify the maximum tolerated     dose (MTD) using a traditional 3+3 dose escalation design of the WEE-1 inhibitor AZD1775 when     added to standard of care chemotherapy (cisplatin) and radiation for the treatment of locally     advanced squamous cell cancer of the head and neck (HNSCC).   "
53450|NCT02585960|"     1. To compare the efficacy and safety of PK-guided treatment with BAX 855 targeting FVIII          trough levels of 1-3% and approximately 10% (8-12%)        2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX          855   "
53451|NCT02585947|"     The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV)     reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab     and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to     contribute to the establishment of an effective prevention strategy.   "
53452|NCT02585934|"     This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an     adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.   "
53453|NCT02585921|"     The number of persons actively waiting on the national solid organ waiting list continues to     rise while the number donating organs has failed to keep pace. This is a particular problem     for some portions of northeastern Ohio where the donation rate is as low as 32%. Adolescents     are an important group for organ donation efforts as they have not yet applied for a driver's     license and represent the majority of future donors. Yet many organ donation interventions     have not targeted adolescents. The investigators propose to utilize existing high school teen     summits developed by our Consortium partners to evaluate the effectiveness of existing     donation interventions. Together, the investigators will conduct a randomized controlled 2x2     factorial trial to evaluate the independent and combined effects of two donor education     interventions on consent for organ donation on the electronic Ohio Donor Registry. One     thousand six hundred students over the age of 15.5 years from Cleveland-area high schools     will be enrolled.   "
53454|NCT02585908|"     In this study, safety and effects of γδT cells on human gastric cancer are going to be     investigated.   "
53455|NCT02585895|"     To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low     density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis   "
53456|NCT02585882|"     This was a block-randomized, controlled, open-label trial and was executed in two preschools     in The Gambia. Fluoridated table salt (250 mg F/kg salt) was administered in daily communal     preschool feeding. In total, 304 children in the test group and 137 children in the control     group, aged 3 to 5 years were enrolled according to inclusion criteria (complete primary     dentition and a parental or legal guardian informed consent). Mean difference of incidence of     cavitated carious lesions (Δd3/4mft) after 12 months was the primary end point. The relative     preventive dental caries effect was. Secondary end points were the difference of incidence of     white spot lesions and the difference of incidence of total carious lesions.   "
53457|NCT02585869|"     The purpose of this study is to evaluate the effect of gemcabene on HDL‐C, LDL‐C, TG, and     other lipid levels in patients with low HDL‐C   "
53458|NCT02585856|"     The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in     increasing the survival time, decreasing cholestasis and improving health-related quality of     life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable     cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the     procedure.   "
53459|NCT02585843|"     This is a prospective, single-center, double-blind and randomized placebo controlled trial     for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution of     signs and symptoms of congestion in outpatients with acute decompensated heart failure     (ADHF). Patients who are not responding to their current loop diuretics will be considered     for this study. Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of     care in management of heart failure (HF) patients. However, recommended doses of MRAs     (spironolactone 25mg/daily or eplerenone 50mg/daily) will not have any impact on signs and     symptoms of volume overload. Therefore, the proposed study will aim to show the impact of     this outpatient regimen to improve diuresis and possible reduction in hospitalization for     further diuretic management in HF patients with signs and symptoms of congestion.   "
53460|NCT02585830|"     This study examines the relationship between sleep timing and insulin resistance in     adolescents with obesity. The investigators also aim to develop a physiologically-based     mathematical model of adolescent sleep/wake and circadian interactions.   "
53461|NCT02585817|"     This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED     management model incorporating advanced technological innovation to promote a paradigm shift     to patient-centered care involving remote CIED monitoring and programming. The advancement in     technology is very important as it addresses several potential gaps and barriers in the care     of patients with CIEDS:        1. Long, expensive travel for patients        2. Morbidity to patients due to delay in receiving appropriate treatment        3. Efficiency in health care delivery        4. Patient satisfaction   "
53462|NCT02585804|"     Patients with Focal Segmental Glomerulosclerosis (FSGS) constitute an increasing proportion     of the total glomerulonephritis (GN) patient cohort in North America while FSGS is a risk     factor for end stage renal failure. Current non-immunological FSGS therapies include the use     of angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB),     to reduce intraglomerular hypertension. Unfortunately, these agents lead to incomplete renal     protection. The aim of the current study is to determine whether the addition of novel sodium     glucose cotransport-2 inhibitors (SGLT2i) to standard of care leads to reduced     intraglomerular pressure and suppression of proteinuria. We hypothesize that combination     therapy of SGLT2i drugs and conventional RAASi results in additive renal protective effects     in FSGS patients. A further goal is to examine mechanisms of SGLT2 inhibition by measuring     renal hemodynamic function and sodium handling. Kidney function will be assessed in FSGS     patients before and after an 8 week treatment with SGLT2i dapagliflozin.   "
53669|NCT02583087|"     This study assesses the quality of the resection of early neoplasia arinsing in Barrett's     esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry     among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or     more in size treated by endoscopic submucosal dissection.   "
53463|NCT02585791|"     This aim will examine the acute and subacute exposures to electronic cigarette (EC) vapor     generated from e-liquids without nicotine (NFEC) on life-time non smokers subjects by     measuring changes in nasal ion transport and TGF-β levels. Nasal ion transport will be     assessed by nasal potential difference (NPD). TGF-β levels (mRNA and protein by ELISA) will     be assessed on nasal cells and lavages.   "
53464|NCT02585778|"     Primary Objectives:        -  To demonstrate the superiority of alirocumab in comparison with placebo in the reduction          of calculated low-density lipoprotein cholesterol (LDL-C) in patients with diabetes          treated with insulin and with hypercholesterolemia at high cardiovascular risk not          adequately controlled on maximally tolerated LDL-C lowering therapy.        -  To evaluate the safety and tolerability of alirocumab in patients with diabetes treated          with insulin.      Secondary Objective:      To demonstrate that alirocumab is superior in comparison to placebo in its effects on other     lipid parameters (ie, measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C],     apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)]), high density     lipoprotein cholesterol (HDL-C), triglyceride (TG) levels, triglyceride rich lipoproteins     (TGRL), apolipoprotein A-1 (Apo A-1), apolipoprotein CIII (Apo C-III), and LDL particle     number and size).   "
53465|NCT02585765|"     Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is     reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of     individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since     being injured. Despite the increasing attention and emphasis on prevention, PUs still     represent a major health risk for persons with SCI. Among the numerous potential physical     risk factors identified for the development of a PU were several conditions that have a     significant negative effect on skin blood flow. In addition, improper management of blood     sugar is a major risk factor for PU development and it impedes healing. It would appear that     hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that     target the blood vessels may play an important role in the development and formation of a PU.     In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps the     body use sugar and also relaxes the blood vessels allowing blood flow to increase) in the     lower extremity were shown to be much lower than healthy individuals.      The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic     region PU has 2 phases: (1) a 4-week observation phase [if the PU does not heal     appropriately (determined by digital photos and software computation), and the subject is     found to be insulin resistant then they will progress to the next phase of the study] and (2)     an 8-week treatment phase. All participants will continue to receive the standard wound     care throughout the observation and treatment phases. If the surface area of the PU does not     decrease by more than 30% during the 4-week observation phase, the participant will be     eligible to enter the 8-week treatment phase, in which they will be randomly assigned to     receive active drug (e.g., pioglitazone) or placebo. The participants will have four study     visits in which the following will be acquired: digital image of the wound to monitor wound     surface area, skin blood flow measurements of the peri-wound area, and blood tests to monitor     liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose), nutritional     status (albumin and pre-albumin), a complete blood count with differential, and makers of     inflammation. Weekly monitoring of symptoms and participant experiences will be closely     monitored.   "
53466|NCT02585739|"     Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has     been suggested by family and twin studies, but the mode of transmission seems to vary and the     amount of heritability is unclear.      The number of genetic association studies investigating variants implicated in the     pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms     have been associated with CH. The former has been confirmed and may affect the hypothalamic     hypocretin system. The aim of the present study was to investigate the possible link between     SPINK 1 gene and cluster headache.   "
53467|NCT02585726|"     The VenaSeal Closure system offers an outpatient treatment option for the permanent closure     of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through     endovascular embolization with coaptation. VenaSeal is intended for use in adults with     clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).   "
53468|NCT02585713|"     This randomized phase III trial studies the side effects of and compares apixaban and     dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism.     Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks     off and moves through the bloodstream. Patients with cancer are at increased risk for venous     thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming     or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin     is more effective in reducing blood clots in patients with cancer related venous     thromboembolism.   "
53469|NCT02585700|"     This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of     participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1;     A/H3N2 and B) or placebo (phosphate buffered saline). A total of 60 healthy male and female     adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).   "
53667|NCT02583113|"     To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA)     vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis     who underwent a primary TKA one side and a primary UKA on the opposite side and are at a     minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along     with all retrospective chart data.   "
53471|NCT02585674|"     Primary Objective:      To demonstrate the non-inferiority of the MyStar DoseCoach (Long-acting Insulin Glargine     Titration Meter) device-supported treat-to-target regimen relative to a routine titration     regimen in the percentage of patients reaching glycemic target, ie, with a mean fasting     self-monitored plasma glucose (FSMPG) value within the target range of 90-130 mg/dL (5.0-7.2     mmol/L) without a severe hypoglycemic episode during the 16-week on-treatment period.      Secondary Objective:      To assess the efficacy, safety, and adherence/satisfaction of MyStar DoseCoach   "
53472|NCT02585661|"     Determination of fractional iron absorption from dairy product fortified with 2 labelled iron     compounds   "
53473|NCT02585648|"     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the     elderly population. Topically administered lubricants are the basis for treatment of this     disease.      Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by     the use of artificial tears during the day. Nighttime relief is often achieved by substances     known to be more adhesive to the ocular surface, such as gels.   "
53515|NCT02585102|"     The purpose of this study is to see if perceived barriers to vegetable consumption can be     overcome by making it easier for people eat more vegetables and to see if the effects last     over time.   "
54321|NCT02574572|"     The purpose of this study is to analyze the safety and efficacy of autologous bone marrow     mesenchymal stem cell transplantation in patients with cervical chronic and complete spinal     cord injury.   "
53474|NCT02585635|"     The MOrPH study is designed to identify optimal prophylaxis schedules for children with     haemophilia. This involves development of combined pharmacokinetic and pharmacodynamic     models. Interpretation of model outputs will be informed by two surveys. The first will     survey families of children with haemophilia to ascertain families' values and preferences     concerning prophylaxis schedules. The second will survey haemophilia physicians to ascertain     the criteria physicians use to prescribe prophylaxis schedules.   "
53475|NCT02585622|"     The study will investigate, primarily, the safety, feasibility and tolerability and,     secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal     Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and     progressive diabetic kidney disease (DKD).   "
53476|NCT02585609|"     The primary focus of this clinical study is the objective and subjective measurements of     sleep quality in patients with advanced cancer using opioids. It also examines sleep     disturbances and associations between sleep quality and symptoms in order to improve symptom     management in patients with advanced cancer.      The overall aim of this study is to improve the clinical understanding of sleep quality in     patients with advanced cancer using opioids and to improve the understanding of how sleep     quality may best be measured in order to improve symptom management.   "
53477|NCT02585596|"     This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients     with chronic periodontitis, in order to investigate the recommended therapeutic dose.   "
53478|NCT02585583|"     The gamma knife radiosurgical thalamotomy to treat many movement disorders is recently     becoming a new and well defined treatment paradigm.      The CyberKnife if compared to the frame-based radiosurgery, is a pain free procedure which     offers the advantage of a better patient's compliance by avoiding local anaesthesia and the     discomfort due to wearing the frame for the period of time needed for the whole procedure.      Unfortunately the subtle but substantial differences about the 3D dose distribution and the     dose fall-off features between GK and CK made mandatory investigations about the     effectiveness and the safety when the cyberknife is used.      Particularly the minimum effective and safety dose have to be defined yet A previous study     (NCT02095600) failed in demonstrating the efficacy of 75 Gy, 80 Gy, 90 Gy.      The aim of the present study is to investigate about the effectiveness of 100 Gy, 120 Gy, 130     Gy and 140 Gy.      The safety and the targeting methodology will be also in investigated.   "
53479|NCT02585570|"     The purpose of this study is to determine whether phenylephrine infusion are effective in the     prevention of hypotension after changing position to beach chair position during general     anesthesia for shoulder arthroscopic surgery.      Investigators hypothesized that by increasing arterial blood pressure with phenylephrine     infusion, incidence of hypotension would be decreased.   "
53480|NCT02585557|"     The objective of this study is to determine if primary care practice support accelerates the     dissemination and implementation of patient-centered outcome results (PCOR) findings to     improve heart health and increases primary care practices' capacity to incorporate other PCOR     findings in the future.   "
53481|NCT02585544|"     Day surgery is performed in the same way as in full hospital admission, allowing same-day     discharge without increased risk. It provides many grounds for patient satisfaction. Progress     in surgical and anesthesia techniques now allows this form of management to be developed and     prioritized.      Day-care surgery for prolapse has been little studied. The present study is intended to help     extend its future implementation, the primary objective being to assess the feasibility of     the day-care approach in prolapse surgery. The secondary objectives are to study criteria of     non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of     failure, predictive factors for failure, patient satisfaction, postoperative complications,     2-year anatomic and functional results, pain, quality of life and sexuality, and     postoperative onset of dyspareunia and urinary incontinence.      The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites     managed by the Lyon hospitals board (Hospices Civils de Lyon).   "
53482|NCT02585531|"     Bronchiolitis is one of the main reasons for consultation in primary care and emergency     services, as well as the leading cause of hospitalization for lower respiratory tract     infection in children under two years. There is still no consensus on the medical management     of the disease, in clinical practice there is wide variability in the treatment with inhaled     drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of     the disease, which results in increased morbidity and a major economic benefit for all health     services.      Several studies are in relation to the management of bronchiolitis, one of which was made     during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing     3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira) (ED),     hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of ED and     SSH 3% had lower rates of hospital admissions compared to the symptomatic management of SS     0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was     demonstrated, it was not possible to establish difference statistically significant between     them. Why it was considered necessary to continue the study focused on determining the     difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this     investigation is to determine whether there is a difference between the use of dexamethasone     and epinephrine versus hypertonic saline (3%).   "
53483|NCT02585518|"     The current study seeks to elucidate the context of pathological and non-pathological eating     behavior in a heterogeneous sample of overweight and obese children, aged 8-14 years.     Children will undergo a two-week ecological momentary assessment (EMA) protocol in which they     record all eating episodes and their physiological, emotional, interpersonal, and     environmental correlates. Specific aims are to identify proximal antecedents and consequences     of pathological and non-pathological eating in overweight and obese children, and to     determine the prevalence of loss of control eating in the natural environment.   "
53484|NCT02585505|"     Stem cells have promising potential in treating diabetes. However the therapeutic outcome in     diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to     label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem     cells will be given through different routes (intravenous and intraarterial)and tissue     distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated     C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be     calculated.   "
53485|NCT02585492|"     The purpose of this study is to determine if the position of the mother in the first two     hours after delivery, while she is in skin to skin contact with your child, influences the     oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful     information for the prevention of seemingly lethal episodes or sudden death of the child     when, following current recommendations is skin to skin contact in the first hours of life.     These episodes are communicating in all developed countries and have caused great concern and     interest in the scientific community. So far we only have information from case series.   "
53486|NCT02585479|"     The purpose of this study is to determine that systemic chemotherapy is superior to     transcatheter arterial chemoembolization in prolonging progression-free survival（PFS） in     patients with Advanced Hepatocellular Carcinoma.   "
53487|NCT02585466|"     Reports have been appearing in literature over the past years of various     nociception-antinociception monitors, introduced and promoted from major manufactures.     Recently a new term Practice misalignment has been recently coined indicating research study     groups that are distant from daily anesthesia practice, with some scientific relevance but     very little clinical relevance simulating purely hypothetical conditions that are not     related to everyday anesthesia practice.   "
53488|NCT02585453|"     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the     elderly population. Topically administered lubricants are the basis for treatment of this     disease. However, exact information about the tear film thickness and the corneal residence     time of topical lubricants is still sparse, therefore no ideal treatment regimen has been     found.      Recently a new method for assessment of tear film thickness based on ultra high resolution     optical coherence tomography (OCT) has become available. The aim of the present study is to     assess tear film thickness and corneal residence time of three different formulations of     topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane®     Gel Eye Drops in patients with moderate to severe dry eye disease. In addition, standard     tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test     and determination of tear break up time (BUT) will be performed.   "
53489|NCT02585440|"     This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of     CMX157 at increasing dose levels.   "
53490|NCT02585427|"     It is now recognized that diet plays a critical role in the etiology and management of the     chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of     fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The     glycaemic index (GI) is a measurement of the ability of different types of carbohydrate-based     foods to raise blood glucose. The interest in low GI food as a weight management tool has     been increasing. Different types of carbohydrates differ in their ability to increase     postprandial blood glucose and insulin secretion, and may also modulate the effect of     different fatty acids. The current study will compare the consumption of low and high GI     carbohydrate with different fat saturation on postprandial glucose, insulin, and     triacylglycerol responses in healthy participants.      The data generated will have direct applications in public health policy and clinical     nutrition management of chronic disease. The outcomes of the study will significantly     contribute to the long term national goals of Singapore to manage and to reduce the incidence     of chronic disease associated with the metabolic syndrome.   "
53491|NCT02585414|"     Dry eye syndrome (DES) is a highly prevalent ocular condition with potential severe     consequences for affected patients. DES can be either caused by decreased tear production or     increased tear evaporation, both leading to an instable tear film. Despite many efforts,     generally accepted methodologies to diagnose, assess the severity and monitor DES are still     lacking. Moreover, widely used clinical methods such as tear break up time (BUT), fluorescein     staining of the cornea or Schirmer test only poorly reflect patients´ complains.      One of the main problems in the diagnosis and treatment of DES is that the most critical     component - the tear film itself - is difficult to characterize. The development of new     ultra-high resolution optical coherence tomography systems allows now for the direct     visualization of the human tear film and for the non-invasive in-vivo measurement of tear     film thickness (TFT). The investigators could recently show that this system provides     excellent reproducibility and is able to assess even subtle changes in TFT induced by     therapeutic interventions. However, to which extent tear film thickness is associated with     other standard clinical measures of DES is currently unknown. In the present study, the     investigators set out to test the hypothesis that ocular TFT is a new and good surrogate     parameter for the assessment of the severity of DES.      Consequently, the aim of the study presented in this protocol is to investigate whether and     if so, to what extent clinical signs of DES and reported symptoms are reflected in ocular     TFT. For this purpose, a cross sectional study in healthy subjects and patients with DES will     be performed. This should allow the investigators to more specifically characterize the role     of the tear film in DES and to assess whether measurement of TFT with OCT can be a promising     surrogate parameter for the diagnosis and the follow up of DES.   "
53492|NCT02585401|"     The primary objective of this study is to measure physician knowledge and understanding of     the key safety information contained in the Eylea vial preparation instruction card, the     intravitreal injection procedure video, and the product monograph.   "
53493|NCT02585388|"     The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase     and metronomic chemotherapy treatment   "
53538|NCT02584803|"     This study is to assess the feasibility of 2 different ultrasound views of the inferior vena     cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy     and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then     allow us to determine the fluid status of the parturient which could be helpful in treating     hemodynamic instability. This study will not involve any change in management of the     participating patients.   "
53505|NCT02585232|"     The purpose of this randomized controlled pilot study is to examine the preliminary     effectiveness, feasibility, and potential treatment moderators (i.e., behavioral symptoms and     spousal relationship status) of a newly developed intervention for individuals with dementia     and their family caregivers that combines elements of the established care consultation (CC)     approach with additional counseling modules (CC+C). Outcomes for Veterans with dementia and     their family caregivers (e.g., depressive symptoms, care-related burden, quality of life,     pleasant events, etc.) will be assessed after 6 months of treatment and again at 12 months.   "
53672|NCT02583048|"     This study will evaluate the safety, tolerability, and pharmacokinetics of the     anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination,     among participants (with or without HIV co-infection) taking multidrug treatment for     multidrug-resistant tuberculosis (MDR-TB) or rifampin-monoresistant TB (RR-TB).   "
53494|NCT02585375|"     Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most     of these eye drops contain preservatives to allow for the use of multi-dose containers. In     the recent years evidence has, however, accumulated that these preservatives may induce     ocular surface disease (OSD). This is particularly true for the most widely used     preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro     and animal studies, evidence from clinical trials is sparse. The only randomized masked study     that showed superiority is a pivotal company-sponsored study indicating improved tolerability     and reduced hyperemia of unpreserved versus preserved latanoprost eye drops.      The investigators have recently introduced an optical coherence tomography (OCT) technology     that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the     investigators were able to show that tear film thickness (TFT) is negatively correlated with     symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level of     resolution as also evident from studies after administration of lubricants.      In the present study, the investigators hypothesize that switching glaucoma patients from     preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase     in TFT as measured with OCT. As a control the investigators will use preserved latanoprost     and the study hypothesis will be tested in a randomized, controlled, single-masked parallel     group design. TFT is chosen as main outcome variable, standard measures for signs and     symptoms of OSD are selected as secondary outcomes. The present study may provide valuable     information on the superiority of unpreserved versus preserved therapy.   "
53495|NCT02585362|"     This study evaluates physical performance in cancer outpatients during a multimodal therapy.     Half of the patients will receive physical exercise und nutrition program in combination with     a specially formulated whey protein supplement, while the other half will receive standard     care.   "
53496|NCT02585349|"     Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the     Netherlands of middle and old age every year. Due to the aging of the population, this figure     will increase considerably over the next decades (Struijs et al., 2005). Twenty-five percent     of stroke patients die within one month, making stroke a major risk factor for premature     death in developed countries. According to the World Health Organization, stroke is the third     leading cause of the burden of disease in middle and high-income countries (World Health     Organization, 2008). It has a significant negative impact on quality of life of both the     patients as well as their caregivers and significant others. Surviving stroke patients often     struggle with its manifold and lifelong lasting consequences, with 35 percent of patients     being functionally dependent one year after stroke (Wolfe, 2000) and cognitive and emotional     changes which are found up to two years post-stroke (Rasquin, Lodder, & Verhey, 2005).     Depression, apathy, and cognitive impairment are very prevalent and significantly contribute     to the burden of the disease, but their etiologies remain poorly understood.      The aim of the CASPER study is to gain more insight into the etiologies of post-stroke     depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and     post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based     predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially     the interaction between cerebrovascular disease, neurodegenerative changes and inflammation     in post-stroke dementia.      CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients with     serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after     baseline.   "
53497|NCT02585336|"     Sugar-sweetened beverages (SSBs) have been epidemiologically linked to serious health     problems including heart disease, liver disease, and diabetes. This study will recruit     frequent SSB drinkers who are employees at the University of California, San Francisco (UCSF)     and measure markers of metabolic health on two occasions, 10 months apart. During this time,     UCSF will cease selling SSBs at all campus and medical center locations. Additionally, at the     first assessment half of participants will be randomly assigned to a brief intervention to     help reduce SSB consumption, consisting of a 10-20 minute semi-structured interview designed     to share health information about SSBs, elicit motivations to reduce consumption, and help     set concrete plans to reduce consumption. The investigators will be able to compare changes     in metabolic health among those who do and do not reduce SSB consumption. This will make a     unique contribution to the growing evidence regarding both the effects of SSB consumption on     health and the modifiability of SSB-related health conditions.   "
53498|NCT02585323|"     Physical activity is an essential first-line treatment for patients with knee osteoarthritis     (OA). However, only 13% of patients meet the activity recommendation of 150 minutes or more     per week. The primary goal of this randomized controlled trial is to assess the efficacy of a     Fitbit Flex (a wireless physical activity tracking device) paired with a new application,     plus a brief education session and telephone counselling by a physiotherapist (PT), to     improve physical activity and reduce sedentary time in patients with knee osteoarthritis.   "
53499|NCT02585310|"     In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and     frequent (number of patients receiving blood). The incidence of side effects are unknown, as     is the exact amount of blood used/provided for patients with elective CABGs.      The primary objective of this study was to demonstrate the incidence of packed red blood cell     (PRBC) transfusion in elective CABGs.   "
53500|NCT02585297|"     Study Goals:        1. Finding the prevalence of bacteria of the sperm in an innovative and more accurate          methode        2. Understanding the effect of microbes on the process of capacitation        3. The impact of microbes in the sperm on IVF success rate        4. Finding the incidence of vaginal bacteria and their relationship to bacteria of the          sperm        5. The impact of vaginal flora on IVF success rate   "
53501|NCT02585284|"     Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS)     value of 46 before anaesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS     value of 52 after propofol anaesthesia recovery. BIS algorithm was heuristically derived from     a database of mostly relatively fit, young healthy volunteers. To date there are no studies     precisely quantifying BIS response to propofol concentrations among different age groups   "
53502|NCT02585271|"     The purpose of this study is to compare the clinical outcomes of transanal decompression tube     as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided     colonic and rectal obstruction.   "
53506|NCT02585219|"     The tracer 11C-methionine (11 C-MET) is used as a specific cell proliferation tracer which     shows metabolically active tumordeposities. A healthy brain barely takes up 11C-MET, causing     the difference between the background and the tumor to be realively high. In addition, there     is relatively little 11C-MET uptake in inflammatory processes. This makes 11C-MET a very     suitable positron emission tomography (PET) tracer in order to differentiate between tumor     progression and therapy changes. The latter is a major clinical problem for which further     investigation is necessary.      In order to be able to make this differentiation, a direct post-operative baseline scan is     required. With regard to the advanced MRI sequences, it is known that it is necessary to     produce the post-operative baseline scan within 48 hours. After that timeframe, operation     induced changes start to occur, such as granulation tissue. In that case the interpretation     of the scan is no longer possible. Immediately postoperatively (<48 hours) 11C-MET has never     been used before. Therefore, it is unknown whether 11C-MET provides a good baseline scan     directly after surgery. This pilot will investigate the feasibility of this 11C-MET baseline     scan and comparison the results with the advanced MRI sequences.   "
53507|NCT02585206|"     This study is comprised of 2 phases to study the impact of a text message system on overall     adherence to a web-based smoking cessation program. Phase I uses a full factorial design to     identify the most optimal text message intervention to maximize adherence to the     BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that     compares regular BecomeAnEX users to those who will receive the optimized text message     intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term     abstinence.   "
53508|NCT02585193|"     While some evidence on weight change elicited from commercially available weight loss     programs, such as Weight Watchers, is available, there is little evidence evaluating any     health-related outcomes that result from losing weight through these programs. In addition,     little data exists on the adherence and satisfaction of these types of programs. The purpose     of this study is to evaluate body weight and health-related outcomes that are achieved from     participating in a Weight Watchers program, along with program adherence and satisfaction.     Men and women (N=150) that are participating in Weight Watchers weight loss program will     undergo assessments at the University of Pittsburgh to evaluate outcomes related to the     Weight Watchers 6 month intervention. Assessment visits, separate from the intervention, will     take place at baseline (0 months), 3 months and 6 months for approximately 90 minutes at the     Physical Activity and Weight Management Research Center. Participants will be asked to     undergo assessments of body weight, height, aerobic stamina, functional fitness, flexibility,     and complete a series of questionnaires related to demographics, program satisfaction, sleep     quality, happiness, and food cravings. Adherence to the program will be measured by the     number of group sessions attended.   "
53509|NCT02585180|"     Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly     by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs     resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the     medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity     to evaluate the accuracy of the subglottic secretions culture surveillance to predict     pathogens involved in VAP (in comparison with the concomitant endotracheal secretions     surveillance). These subglottic and tracheal secretions culture surveillance will be masked     to the investigators of the DEMETER Study.      This ancillary study will be performed in 14 centers participating to the DEMETER study   "
53510|NCT02585167|"     This is a randomised controlled trial to evaluate the outcome of treatment of complex     perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy     and sphincter reconstruction as standard surgical procedure.   "
53511|NCT02585154|"     Parkinson's disease (PD) is a common, disabling, progressive condition characterised by     severe problems with movement for which medical treatment in the longer term can be     unsatisfactory. Deep brain stimulation (DBS) is a treatment, which directly stimulates the     nerve cells affected inside the brain to help overcome the difficulties with movement.     Classically, DBS stimulates in a manner that is constant and independent of a patients     underlying condition as reflected in their brainwave activity. Recent research has suggested     that adjusting DBS in real time using analyses of brain signals recorded from DBS electrodes     (termed closed loop DBS) nay be better than classical DBS in alleviating difficulties with     movement. However, it remains unclear whether closed-loop DBS also leads to fewer unwanted     side effects on movement control.In order to answer this question, the investigators will     analyze DBS activity and activity recorded from the surface of the head in PD patients     undergoing DBS surgery. During the recordings patients will perform different movement tasks.     DBS has been found to reduce patients' ability to suppress inappropriate movements in certain     tasks and performance in these tasks will be the core point of interest. The recordings will     be conducted three times: During closed loop DBS, classical DBS and while the stimulator is     turned off. This will allow the investigators to assess putative differences in the effect of     closed loop and classical DBS with regards to wanted and unwanted effects on movement control     and to elucidate their correlates in the brain.   "
53512|NCT02585141|"     The purpose of this study is to compare aspiration and oral antibiotics with surgical     incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula     formation. Included patients will be randomised to either aspiration or incision.   "
53539|NCT02584790|"     NBI has been proven to be a useful tool to detect early NPC, but they were few studies     concerning the detection of post-radiotherapy mucosal residual NPC using NBI system   "
53540|NCT02584777|"     To evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of     pacritinib in Asian subjects with myelofibrosis (MF), which includes primary MF (PMF),     post-polycythemia vera MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF).   "
53513|NCT02585128|"     Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive     characteristics: they are old, frail, with several co-morbidities and take multiple     medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and     hospitalization in intensive care expose those patients to postprocedural delirium.      Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.      The objective of this study is to determine the incidence of delirium and neurocognitive     disorders in elderly patients after TAVI.   "
53516|NCT02585089|"     Spanish dry-cured ham has been shown a source of antihypertensive peptides in mice. To date,     no clinical study has been performed in humans to check the effects of bioactive peptides     produced naturally during the processing of pork dry-cured ham on blood pressure. Therefore,     the aim of the present study is to investigate whether consuming peptides from cured pork ham     with demonstrated angiotensin I-converting enzyme (ACE) inhibitory activity lowers blood     pressure (BP) and improves other risk factors for cardiovascular disease (CVD).      Objectives: To demonstrate the lowering effects of bioactive peptides from cured pork ham     with >10 months dry-curing process in humans. To check for other possible benefits related to     dry-cured ham intake such as: platelet activation and cardiovascular risk factors.   "
53517|NCT02585076|"     Arterial hypertension has been recognized as a major causal factor for atrial fibrillation     (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing     prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic     events and mortality, AF has emerged as a global healthcare problem.      Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for     the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the     management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use of     a risk factor-based approach to stroke risk stratification for AF patients.      This study aims towards gaining real-world data on the prevalence of non-valvular atrial     fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent     antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors     influencing treatment decision-making will be assessed as well in patients diagnosed with the     arrhythmia.      Finally, potential differences in the NVAF prevalence in adequately and inadequately     controlled hypertensives will be documented.   "
53518|NCT02585063|"     The UK government's Crown report titled 'Review of prescribing, supply & administration of     medicines' enabled optometrists to train for the qualification of independent prescribing     (IP). The UK introduced IP for optometrists in 2009. The proposed research focuses on the     role of IP optometrist in the acute ophthalmic services of Manchester Royal Eye Hospital     (MREH). The study will compare IP optometrists to consultant ophthalmologists in the ability     to diagnose, manage and prescribe medication for patients accessing these services.      To achieve this comparison consenting participants will first have a clinical assessment with     the IP Optometrist, where findings including diagnosis and management plan will be recorded     onto a research proforma. The consultant ophthalmologist will be masked to the IP     Optometrist's research proforma to prevent bias. The consultant ophthalmologist will then     perform a clinical assessment on a second proforma and inform the participant of their     diagnosis and management plan. Percentage agreement, kappa (κ) and weighted κ will be     calculated for a range of parameters between the two proformas. Disagreement in diagnosis or     management will be arbitrated by a separate ophthalmologist participating in the study with a     specialty relevant to the participant's condition.      The main objective of the research is to expand the limited base of evidence of of IP     optometrists' ability to diagnose, manage and prescribe medication and to determine whether     they work at least as safely and effectively as consultant ophthalmologists in acute     ophthalmic services. It is the first study in this area since the advent of IP for     optometrists, with only one previous study published before IP was introduced. The research     will enable the type and frequency of conditions presenting in these services to be measured.     Furthermore it will identify conditions that IP optometrists can manage independently and     enable guidelines for these conditions to be developed.   "
53519|NCT02585050|"     Debates about the official and legal implementation of Do not attempt resuscitation (DNAR)     orders are ongoing. The aim of this study was to determinate factors that influence     neurological outcomes at discharge and the ratio of living patients discharged from the     hospital due to DNAR prohibition.   "
53520|NCT02585037|"     The Kinesio Taping® method, therapeutic bandage, is another feature can be used in physical     therapy, aiming to muscle enhancement, weakened muscles correction, analgesia, among others,     by cutaneous stimulation of mechanoreceptors. This study aims to evaluate the efficiency of     the use and effects offered by Kinesio Taping® method, changes in muscle strength of grip in     normal subjects for clinical application.   "
53521|NCT02585024|"     A number of pharmacotherapies are available for smoking cessation in New Zealand including     nicotine replacement therapy, bupropion, an antidepressant medication and varenicline. Of     these, varenicline is the most effective, but also the most expensive. Varenicline acts like     nicotine and stimulates nicotine receptors in the brain, but to a lesser extent, and     simultaneously block nicotine binding to its receptors and thus reduces the rewarding effects     of cigarette smoking. Cytisine (Tabex® and Desmoxan®) is a plant alkaloid and also acts in a     similar way to varenicline but is significantly cheaper. It has been used for more than 50     years in some parts of eastern and central Europe as an aid to quit smoking, but is not     approved for use in many countries such as New Zealand, Australia, the UK or the US.     Randomised, placebo-controlled trials have shown that cytisine is more effective than placebo     and nicotine replacement therapy (NRT)for smoking cessation. However there is a paucity of     pre-clinical data on cytisine. In particular, there are limited data on the pharmacokinetic     and the dose response characteristics of cytisine. Furthermore, the current dosing regimen     recommended by the manufacturer is complex and has no clear basis in empirical research.      Complexity of dosing has been shown to be a key factor in determining adherence. Therefore, a     simpler regimen would likely maximise the effectiveness of treatment through improved     adherence to the treatment regimen. The investigators therefore propose to undertake two     studies to investigate the influence of dose, dosing frequency and dosing duration on the     pharmacokinetics and tolerability of cytisine and cigarette craving in smokers.   "
53622|NCT02583698|"     250 Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12     mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute     of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed     consent.   "
53522|NCT02585011|"     At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250     of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces     morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key     prerequisites for early rehabilitation is optimized pain relief. Local infiltration     anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving     hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine     after hemiarthroplasty has not been investigated in clinical trials. In this study it will be     investigated whether a single shot with Ropivacaine reduces acute postoperative pain and     opioid requirement after hemiarthroplasty. The findings of this study will have a direct     impact on patient treatment.   "
53695|NCT02582749|"     Newly diagnosed metastatic prostate cancer subjects with bone metastases will be accrued to     this stratified randomized 2-arm Phase II trial. Subjects will be randomized 1:2 to ADT or     ADT with Radium-223 dichloride respectively.   "
53523|NCT02584998|"     The main study aim is to develop, implement and disseminate a pilot population-based mailed     FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on     having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic     randomized trial to (1) Compare the effects of usual care (UC), screening invitation +     reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder     (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity;     and (3) Explore barriers to use of mailed outreach screening for Veterans.   "
53524|NCT02584985|"     Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME).     Originally performed by open surgery, TME demonstrated improved local control and reduced     urogenital morbidity. Laparoscopic approach has been validated by several randomised     controlled trials: laparoscopic approach offers to the patient a better post-operative     recovery, a lower risk of wound hernia and comparable oncological results. However, the risk     of conversion to open procedure remains significant.      Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole     pelvic dissection via a specific-moderate cost device. The procedure is then completed by a     briefer transabdominal laparoscopic step to mobilise the colon and perform inferior     mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this     approach is to perform a surgical dissection via an extra peritoneal route, without     peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area     of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This     approach offer closer and better exposure of pelvic dissection plane and could improve     oncological quality and pelvic nerve preservation. It could be profitable to postoperative     patient outcome. However rates and type of cancer-recurrences as well as functional results     have to be assessed in a controlled study. This technique has shown to be feasible and     reproducible through early clinical series. Conversion rates appear to be lower than     published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of     morbidity (27.8%), R1 resection* (6%), mesorectum macroscopic integrity (100%) appear to be     comparable to laparoscopic approach results. However functional results as well as urologic     morbidity have to be evaluated in comparative studies. In a preliminary retrospective     comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs     10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to     open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038).     Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2     80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date,     Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including     several short series demonstrating the feasibility of the technique and showing low     morbidity. For some authors the benefit of transanal approach is significant in difficult     cases such as male patient and narrow pelvis. Very recently, two non randomised comparative     studies were published with conclusions close to those in our study.      Investigators propose, with the support of the GRECCAR group, to conduct a national,     multicenter, open-label randomized study based on oncological non-inferiority (R1 resection     rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard     Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual     colo-anal anastomosis. There is a clear expected benefit expected for the patients through     the ETAP procedure in term of post operative short term outcome, risk of conversion to open     procedure, risk of wound hernia.This trial could also show significant advantages in terms of     quality of dissection, quality of the specimen, quality of nerve preservation.   "
53525|NCT02584972|"     Lately, many researchers have found that Children with autism spectrum disorder (ASD) are     most likely to have gross motor deficiencies such as lack of coordination in gait and     balance. Much has been researched on etiology and motor learning, but only very few     researches have examined and analyzed quantitatively gait and balance in ASD. The aim of this     research is to analyze quantitatively balance, gait and balance during perturbation in     children with ASD and to compare with typically developed children (TD). A group of 20     children diagnosed with ASD and a control group of 20 TD children will be recruited and     tested in the laboratory with well-established measures of gait and balance function. They     will be instructed to stand as still as possible on a force plate with different task     conditions : (1) standing with the eyes open (EO) - standing upright viewing an X displayed     on a screen 3 meters in front of them; (2) eyes closed (EC) - same as (1) with the eyes     closed and covered by blindfolds (i.e. no visual information). (3) Same as 1 standing on foam     (i.e., conflicting proprioceptive information). Gait will be measured using the narrow base     walk test, modified for clinical use. Participants will be asked to walk within a narrow path     6 meters long . The statistical analysis will include Independent T-tests to compare the ASD     and controls with respect to different characteristics. General Linear Model (GLM) will be     used by applying a separate model where the dependent variables will be the average values of     the postural stability or gait stability parameters (continuous) and the independent     variables were categorical by the group and task condition.   "
53526|NCT02584959|"     The purpose of this study is to assess the efficacy and safety of subcutaneous administration     of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in     adolescent and adult subjects with hereditary angioedema.   "
53527|NCT02584946|"     The aim of the proposed study is to examine whether long-term dietary supplementation (8     weeks) of an oat flour cookie rich in avenanthramides (AVA) could enhance blood antioxidant     capacity and reduce blood inflammatory markers after a downhill running (DR) protocol among     human subjects.   "
53528|NCT02584933|"     The rollover study will provide ceritinib to patients who are currently receiving treatment     with ceritinib within a Novartis-sponsored study and in the opinion of the investigator,     would benefit from continued treatment with ceritinib.   "
53529|NCT02584920|"     Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01     and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.   "
53530|NCT02584907|"     In this randomized, double-blind clinical trial, eligible hospitalized ICU patients with EN     will be included. Patients will be divided into two groups. The control group with the     standard EN and intervention group with high fat EN. 50% of the total fat will be provided by     olive oil. Nutritional intake record form will be completed and daily calorie intake will be     calculated. High fat EN feeding will be offered for 15 consecutive days maximally. At the end     of the study mean blood glucose, duration of hospitalization and rate of infection will be     compared in two groups.   "
53531|NCT02584894|"     The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary     reactivation of personal traumatic memories with neuromodulation of the right dorsolateral     prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.   "
53532|NCT02584881|"     Using a quasi-experimental design the investigators will compare the effect of adopting and     implementing a Safe Opioid Prescription Practice (SOPP) protocol within a Level 1 trauma     service team compared to a Level 1 trauma service team implementing standard care.   "
53533|NCT02584868|"     This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during     elective open-heart surgery in pediatric patients.   "
53534|NCT02584855|"     The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab     compared to placebo in participants with active psoriatic arthritis.   "
53535|NCT02584842|"     The purpose of this study is to determine retrospectively if the application of rivaroxaban     after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the     risk of venous thrombosis.   "
53536|NCT02584829|"     This phase I/II trial studies the side effects and how well localized radiation therapy or     recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy     works in treating patients with Merkel cell carcinoma that has spread to other parts of the     body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Interferon beta is a substance that can improve the body?s natural response and may interfere     with the growth of tumor cells. Monoclonal antibodies, such as avelumab, may help T     lymphocytes kill tumor cells. For cellular adoptive immunotherapy, specific white blood cells     are collected from the patient's blood and treated in the laboratory to recognize Merkel cell     carcinoma. Infusing these cells back into the patient may help the body build an effective     immune response to kill Merkel cell carcinoma. Giving localized radiation therapy or     recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy may     be a better treatment for Merkel cell carcinoma.   "
53541|NCT02584764|"     The primary aim is to develop, and test the feasibility and efficacy of, a manual based,     cognitive behaviour therapy (CBT) treatment for Hoarding Disorder (HD) delivered in a group     format combined with an Internet support system. The investigators' secondary aim is to     investigate the neurocognitive profile of the participants before and after treatment in     order to explore if the treatment might have an impact on neurocognitive functioning and if     certain neurocognitive profiles predict outcome.      For the primary aim, the investigators hypothesize that the treatment will be acceptable to     participants and decrease symptoms of hoarding. Regarding the secondary aim, the     investigators hypothesize that deficiencies in executive functioning, as measured with a     neurocognitive battery, will reduce upon completion of treatment and that baseline executive     function will be associated with treatment outcome.   "
53542|NCT02584751|"     Respiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease (GERD)     have been demonstrated to be highly prevalent in persons with SCI. GERD has been linked to     respiratory symptoms and conditions such as asthma, chronic cough, and an increased rate of     respiratory infections in the general population. In persons with asthma, respiratory     symptoms and dependency on asthma medications have been reduced by treatment with anti-reflux     medication. Possible mechanisms have been proposed for this link, including the     microaspiration of reflux materials, which may result in airway acidification and aspiration     pneumonia, or the stimulation of the vagus nerve through acid-sensitive receptors in the     esophagus with associated esophageal inflammation and reflex bronchoconstriction.     Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in     persons with SCI on objective and subjective symptoms of respiratory function to determine     the underlying mechanisms of airway inflammation due to GERD.   "
53543|NCT02584738|"     The purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate     in patient with moderate to severe asthma exacerbation in pediatric emergency   "
53544|NCT02584725|"     The purpose of this study is to determine the effect of increasing doses of tranexamic acid     (TXA) on limiting blood loss during total knee and total hip arthroplasty as defined by a     change in hemoglobin from pre-operative baseline to the first post-operative day.   "
53545|NCT02584712|"     The aim of this study is to evaluate the effect of exercise training in the autonomic nervous     system activity in breast cancer patients, who underwent doxorubicin medication.   "
53546|NCT02584699|"     This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF)     of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12     F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC)     non-small cell lung cancer (NSCLC).   "
53547|NCT02584686|"     Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in     the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth     muscles help in the treatment of resistant erectile dysfunction not responding to medical and     injection therapy, thus avoiding surgical treatment options.      The treatment group will be injected intracavernously with 50 units of BTX-A. The control     group, 12 patients, will be injected with a normal saline injection.   "
53548|NCT02584673|"     The objective of this research is to verify the procedural improvements enabled by use of a     CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary     focus will be procedures performed by the Anesthesia department.   "
53549|NCT02584660|"     The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants     who are discharged from the Emergency Department (ED) to the home environment and treated     with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or     venous thromboembolism (VTE) events through Day 30 compared to participants who are treated     with initial hospitalization and standard-of-care.   "
53550|NCT02584647|"     The purpose of this study is to determine if treatment with PLX3397 and Sirolimus will be     tolerated and result in shrinking of the cancer or stopping the cancer from growing. In the     phase I portion, the maximum tolerate dose of the study drug will be determined. In the Phase     II portion, progression free survival will be assessed at the dose level found in Phase I.     Participants will continue to take the study drug until they experience an unacceptable side     effect or their disease progresses.   "
53551|NCT02584634|"     The purpose of this study is to evaluate the safety and efficacy of avelumab when combined     with either crizotinib or PF-06463922.   "
53552|NCT02584621|"     The proposed study is a randomized controlled trial that compares the effectiveness of an     electronic personalized health screening app incorporating motivational feedback (i.e. Check     Yourself) to usual care among moderate to high risk alcohol users. The purpose of this study     is to determine whether Check Yourself is more effective than usual care in reducing alcohol     consumption and binge drinking and improving quality of care among adolescents receiving     school-based health clinic services.   "
53553|NCT02584608|"     This study is an open label use of ACTIMMUNE for patients with Autosomal Dominant     Osteopetrosis Type 2(ADO2). Effects of treatment will be evaluated after 14 weeks on     ACTIMMUNE by bone resorption markers. This study will treat 12 patients with ADO2 recruited     from Indiana University and Riley Hospital for Children at Indiana University Health.   "
53554|NCT02584595|"     The intent of this observational study is to understand the role of non-invasive programmed     stimulation (NIPS) to induce substrate based MMVT in patients receiving new St. Jude Medical     ICD or CRT-D systems.   "
53555|NCT02584582|"     Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent     of the gastric emptying rate.   "
53556|NCT02584569|"     This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme     occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide     dosing and schedule for future clinical studies in schizophrenia with TAK-915.   "
53557|NCT02584556|"     The purpose of this study is to determine that adjuvant systemic chemotherapy is superior to     adjuvant transcatheter arterial chemoembolization(TACE) in prolonging recurrence free     survival（RFS） in patients after radical resection of hepatocellular carcinoma.   "
53623|NCT02583685|"     This is a prospective, randomized study to evaluate the efficacy and safety of switching     treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with     CHC genotype 1b infection, who are interferon/ribavirin-intolerant.   "
53558|NCT02584543|"     This is a open label, randomized phase VI study, to assess the safety and immunogenicity of     co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n     =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months     1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and     months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1     and months 1 and 6.      Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were     monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.   "
54322|NCT02574559|"     The purpose of this study is to determine if caregivers of children with a developmental     delay experience a decrease in stress by participating in a meditation/cognitive training     protocol.   "
53559|NCT02584530|"     This is a randomized controlled study comparing US guided vs standard procedure for PICC line     placement in newborns admitted to Children's Hospital of Eastern Ontario Neonatal Intensive     Care Unit who require a PICC line. Patients will be randomized using REDCap randomization     module (stratified by gestational age < 28 weeks and >= 28 weeks and blocked to ensure     approximate balance with each stratum) into two arms. - Arm 1: PICC line insertion procedure     using anatomical landmarks and tip placement will be confirmed by X-ray (current standard);     Arm 2: US guided PICC line insertion procedure and tip placement confirmation by both US and     X-ray. Sample size of 33 infants per group would achieve greater than 80% power to detect a     difference between groups.      Primary outcome: Time to complete the standard versus the US-guided procedure.      Secondary outcomes (comparison between two arms):      The number of total venipuncture attempts needed to place a PICC line Number of tip     manipulations after complete insertion Proportion of successful tip placement   "
53560|NCT02584517|"     Giant Cell Arteritis (GCA) is the most common vasculitis and has significant morbidity in     terms of blindness, stroke, and tissue necrosis. It requires protracted treatment with     high-dose steroids, and despite this there is a risk of flare during the treatment. Little is     known about the initial triggers for the inflammatory process, and there are no good markers     of response or relapse. We will study patients referred with suspected GCA to identify     important components of the immune response in GCA, and follow them over time to collect     evidence of how best to monitor their condition.   "
53561|NCT02584504|"     Primary Objective:      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab     administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet     therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of     treatment in patients with hypercholesterolemia.      Secondary Objective:        -  To evaluate the effect of two treatment regimens of alirocumab on other lipid          parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non          HDL-C), total cholesterol (TC), lipoprotein (a) [Lp(a)], high-density lipoprotein          cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).        -  To evaluate the safety and tolerability of alirocumab administration.        -  To evaluate the development of anti-alirocumab antibodies.        -  To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab          administration.        -  To evaluate the long-term safety in patients receiving open-label alirocumab          administration.   "
53562|NCT02584491|"     The purpose of this study is to determine the associations between changes in neural activity     and structure, advanced gross motor skills, gait characteristics, and physical activity     participation following a gait-related intervention that is based on motor learning     principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy. The     investigators' hypothesis is that in conjunction with a program of motor learning based     training, functional neuroplastic changes in the involved motor areas will be strongly     associated with changes in gait and advanced gross motor skills, moderately associated with     physical activity based participation changes, and will have a fair association with     structural neuroplastic change.   "
53563|NCT02584478|"     This trial is a Phase 1b/2a trial designed to evaluate the safety and efficacy of adding oral     AL3818 to standard platinum-based chemotherapy concurrently and continued as a maintenance     therapy for up to 12 months.   "
53564|NCT02584465|"     The objective of this randomized phase II is to evaluate the benefit of regorafenib for     ovarian patients who reported a confirmed elevated CA-125 level under surveillance or     bevacizumab, compared with tamoxifen.   "
53565|NCT02584452|"     Despite the apparent multifaceted benefit in differentiating blockade sites and duration of     nerve blockade, the efficacy of continuous adductor canal blockade utilized specifically in     ACL reconstruction has not been extensively studied. This study will test the hypothesis that     the use of the adductor canal continuous nerve catheter will result in lower subjective pain     scores on postoperative day 2 and improved quadriceps strength on postoperative day 1.   "
53566|NCT02584439|"     The conduit arteries exhibit a viscoelastic behavior. Visco-elasticity is partially regulated     by endothelium and contributes to the optimization of the heart-vessel coupling. Aging or     high resting heart rate (HR) could alter visco-elastic properties leading to increase     stiffness of the conduit arteries, an independent cardiovascular risk factor, and degradation     of heart-vessel coupling. Lowering HR with ivabradine could reduce these effects.      The objective of this study is to assess the effect of HR reduction by repeated     administration of ivabradine on visco-elastic properties, vascular geometry and function of     common carotid artery, and on cardiovascular hemodynamic in healthy subject. The influence of     aging on ivabradine effects are studied too.      30 healthy volunteers aged between 25 and 65 years old, with a HR ≥ 70 bpm, will receive     ivabradine or placebo during 8 days in a single center, randomized, cross-group, double     blinded, placebo-controlled study. Each period of treatment will be separate by 12 to 16 days     of wash-out. Each subject will participate in an exploration visit, including evaluation of     visco-elastic properties, vascular geometry and function of common carotid artery, and     cardiovascular hemodynamic, before and after ivabradine or placebo taking.   "
53625|NCT02583659|"     This prospective cohort study aims to observe the efficacy and safety of the first-line     combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.   "
53668|NCT02583100|"     This is a pilot study to determine if an audit and feedback intervention decreases     complication rates after cleft palate surgery.   "
53567|NCT02584426|"     Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is     reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of     individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since     being injured. Despite the increasing attention and emphasis on prevention, PUs still     represent a major health risk for persons with SCI. PUs and other skin breakdowns are at risk     for becoming infected; it is not uncommon for many different types of bugs to be found in     the wound. It has been assumed that the presence of these organisms did not impede wound     healing or skin graft survival. The current proposal will use a new type of procedure that     involves the direct injection of an antibiotic (in saline) into the skin beneath the wound;     it is then distributed throughout the wound using a second device that uses sound waves. The     study will determine if the antibiotic treatment and the standard of care improves the rate     wound closure compared to the standard of care alone in persons with SCI and a chronic     pelvic-region PU.   "
53568|NCT02584413|"     Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during     annual ophthalmologic exams. However, because these exams are annual, it is possible for     healthcare providers to miss the point at which a child's vision begins to decline     (potentially indicating an OPG). If at-risk children are screened for hypotonia early in     life, those children who are hypotonic may undergo magnetic resonance imaging (MRI) to     evaluate for OPG before they are showing ophthalmologic symptoms. This would enable     healthcare providers to discover vision loss earlier and treat symptomatic OPGs earlier,     thereby allowing us a better chance of preventing further vision loss in children with OPGs.   "
53569|NCT02584400|"     Regulation of tissue oxygen homeostasis is critical for cell function, proliferation and     survival. Evidence for this continues to accumulate along with our understanding of the     complex oxygen-sensing pathways present within cells. Several pathophysiological disorders     are associated with a loss in oxygen homeostasis, including heart disease, stroke, and     cancer. The microenvironment of tumors in particular is very oxygen heterogeneous, with     hypoxic areas which may explain our difficulty treating cancer effectively. Prostate     carcinomas are known to be hypoxic. Increasing levels of hypoxia within prostatic tissue is     related to increasing clinical stage, patient age and a more aggressive prostate cancer.     Several researches indicated that hypoxia might also play a role in esophageal cancer. In     glial brain tumors, hypoxia is correlated with more rapid tumor recurrence and the hypoxic     burden in newly diagnosed glioblastomas is linked to the biological aggressiveness. In brain     metastases CA-IX expression (a marker for hypoxia) is correlated to the primary non-small     cell lung carcinomas. Hypoxia enhances proliferation, angiogenesis, metastasis,     chemoresistance and radioresistance of hepatocellular carcinoma. The hypoxic markers HIF-1α,     VEGF, CA-IX and GLUT-1 were all over expressed in colorectal cancer and its liver metastases.     Based on literature, hypoxia in tumors originating or disseminated to prostate, esophagus,     brain and rectum cancer will be studied in this trial.   "
53570|NCT02584387|"     This study seeks to examine a Virtual Reality Exposure Therapy (VRET) using the 3D Video     Virtual Reality (VR) technology for the fear of spiders.   "
53571|NCT02584374|"     Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to     diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and     two-plane phlebography are able to show compression, not all suspected iliac vein     compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic     value, but is far more expensive. In our experience a balloon occlusion test in the common     iliac vein during phlebography can diagnose iliac vein compression due to the collateral     network that is visualised. The general consensus is that pelvic collaterals are a sign of     pathology, though the investigators would like to validate this test by showing that a     balloon occlusion test in healthy subjects does not identify a collateral network.   "
53572|NCT02584361|"     This study investigate weather one type of cochlear implant (CI) surgery (insertion of the     electrode via paracentesis of the round window (RWA)) leads to less vertigo than another type     of CI surgery (cochleostomy). The participants will be randomized into 2 groups: RWA or     cochleostomy. They will be examined with a video head impulse test (vHIT) before and after CI     surgery to clarify their vestibular function.   "
53573|NCT02584348|"     Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric     contents. It has been previously reported that bedside two-dimensional ultrasonography can be     a useful tool for anesthesiologists to determine gastric contents and volume in adults and     children.      In this prospective study, preoperative qualitative ultrasound assessment of gastric contents     is performed for each children admitted for emergency surgery, in order to plane in case of     empty stomach an intravenous or inhalation technique induction rather than an rapid sequence     induction.   "
53574|NCT02584335|"     The purpose of this study is to evaluate if applying a lidocaine topical solution before     wounds treatment decreases the pain of the procedure in comparison with placebo solution.   "
53577|NCT02584296|"     Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid     Leukemia   "
53636|NCT02583516|"     The purpose of this study is to evaluate the efficacy and safety of two different schedules     of administration of vemurafenib in combination with cobimetinib (continuous and     intermittent) in previously untreated BRAFV600- mutation positive patients with unresectable     locally advanced or metastatic melanoma.   "
56271|NCT02549092|"     The primary objective of this study is to examine the effect of Levodopa-Carbidopa Intestinal     Gel (LCIG) relative to that of OMT on non-motor symptoms associated with Parkinson's disease     (PD).   "
53578|NCT02584283|"     Rationale: Recent publications report good results of controlled donation after circulatory     death (DCD) Maastricht category III liver transplantation when strict donor-recipient     matching is applied and ischemia times are kept to a minimum. However a major concern remains     the high rate of biliary complications after transplantation of DCD livers. Non-anastomotic     biliary strictures (NAS) occur in 29% of patients receiving a DCD graft whereas the incidence     of NAS in recipients of donation after brain death (DBD) liver grafts is 11%. NAS are     associated with higher morbidity and increased cost of liver transplantation. Injury to the     biliary epithelium and the peribiliary vascular plexus occurring during donor warm ischemia     and static cold storage (SCS) has been identified as a major risk factor for development of     NAS. Machine perfusion has been proposed as an alternative strategy for organ preservation,     offering the opportunity to improve the quality of the organ by providing oxygen to the     graft. Experimental studies have shown that end-ischemic dual hypothermic oxygenated machine     perfusion (DHOPE) helps liver grafts to recover from ischemia by restoring mitochondrial     function. Moreover, DHOPE has been shown to provide better preservation of peribiliary     vascular plexus of the bile ducts, which could be an important step forward in reducing the     incidence of NAS after transplantation.      Objective: To study the efficacy of end-ischemic DHOPE in reducing the incidence of NAS     within six months after controlled DCD (Maastricht category III) liver transplantation.      Study design: An international, multicenter, prospective, randomized, controlled,     interventional, clinical trial with a two parallel arm approach (treatment/control).      Study population: Adult patients (≥18 yrs old) undergoing a liver transplantation with a     liver graft procured from a controlled DCD donor (Maastricht category III) with a body weight     ≥40 kg.      Intervention: In the intervention group liver grafts will be subjected to two hours of     hypothermic, oxygenated perfusion at the end of SCS and before implantation. In the control     group donor liver grafts will be preserved in accordance to standard practice by SCS only.      Main study parameters/endpoints: The incidence and severity of symptomatic NAS as diagnosed     by an Adjudication committee (who are blinded for the group assignment) by means of magnetic     resonance cholangiopancreatography (MRCP).   "
53726|NCT02582346|"     This project aims at assessing two MRI acquisition methods, neurography and tractography, for     the visualization of pelvic nerves. The goal is to optimize both methods and to test them on     a pool of volunteers to assess if nerves can be delineated, so as to provide an     individualized mapping of nerves to surgeons before an intervention and avoid postoperative     complications.   "
53579|NCT02584270|"     This study will fill a scientific gap in the current knowledge providing data for evaluation     of the palatal augmentation prosthesis as a therapeutic modality in a robust scientific     randomized prospective clinical trial. Positive outcomes from this study have the potential     to dramatically alter the most common morbidity of oral cancer therapy, namely speech and     swallowing function in a population of patients with T1/T2 tumors of the tongue who are not     currently routinely recommended for a palatal augmentation prosthesis.   "
53580|NCT02584257|"     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test     product to the reference product, using bronchoprovocation (methacholine challenge testing)     in adult patients with stable mild asthma.   "
53581|NCT02584244|"     The overall goal of this feasibility study is to assess the initial safety and efficacy of     LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers     (adenocarcinoma) using the LUM 2.6 Imaging Device.   "
53582|NCT02584231|"     Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are     all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment     resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot     study performed at our department showed a correlation between weight and plasma     concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to     the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics     (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old.     Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary     concentration testing will be evaluated   "
53583|NCT02584218|"     This study aims to evaluate, through a controlled clinical randomized study, the     effectiveness of sealing carious lesions with composite resin in primary molars. For this,     healthy children (n=100) with caries lesion reaching to the middle third of the dentin of     primary molars, will be submitted to different treatments to remove the lesions. These     patients will be randomly allocated in the following treatment groups: (1) cavity sealing     (Non-invasive resin based dental sealing) without caries removal; and (2) Partial caries     removal and Invasive resin based restoration. The clinical and radiographic success of the     treatment groups will be verified by periodic examination of the restorations by USPHS     criteria and radiographic subtraction, respectively, which will be checked progression or not     of injury. The researcher responsible for these assessments will be blind to the study, whose     evaluations will occur after 6, 12, 24 and 36 months of treatment.   "
53584|NCT02584205|"     Obstructive sleep apnea (OSA) is a chronic, progressive and disabling disease and can affect     functional capacity due to the weakness of the respiratory muscles. Therefore, the objective     of this study is to evaluate the effect of inspiratory muscle training on functional capacity     in patients with OSA. A pilot study will be conducted to calculate the sample. Individuals of     both genders, diagnosed with obstructive sleep apnea moderate or severe (measured by     polysomnography) will be invited and the data collected in the Sleep Laboratory of the     Pronto-Socorro Cardiológico de Pernambuco (PROCAPE), located in Recife- PE- BRAZIL. The study     deals with a test-clinical randomized double-blind.The intervention groups held inspiratory     muscle training (IMT) and the load is equivalent to 40% of maximal inspiratory pressure     (MIP). The evaluations will be performed once a week during twelve weeks. Control groups will     be submitted to a simulated training with load less than 10% of MIP (insufficient charge to     train the muscles), during the same period as the intervention group. The guidelines for the     training and weekly evaluations will be performed by the responsible for the researcher     physiotherapist in Cardiopulmonary Physical Therapy Laboratory (LACAP- UFPE). After the     training period, the groups will be reassessed by the evaluation tests of functional capacity     (ADL- Glittre Test and Ergospirometry), inspiratory muscle strength (manometer) and lung     function (spirometry) and then compared. Expected results: The interventional groups will     improve their functional capacity.   "
53585|NCT02584192|"     The purpose of this study was to evaluate the effect of this CR program on the improvement of     myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) in     AMI patients.   "
53586|NCT02584179|"     Prostate Cancer (PCa) is the most common male cancer in Denmark and the number is increasing.     Annually, about 1,600 men are referred to the Department of Urology, Herlev Gentofte     Hospital, due to elevated PSA (Prostate Specific Antigen) or clinical symptoms suspicious of     PCa. In approximately 50% of these patients, PCa is diagnosed based on histopathological     findings in tissue obtained from transrectal ultrasound biopsy (TRUS-bx). The TRUS-bx is     taken from 10 standard zones in the prostate. If PCa lesions are visualized on TRUS, they     should appear hypo-echoic compared to the normal peripheral zone. But more than 40-50% of the     cancerous lesions are iso-echoic and thus difficult to identify. Furthermore, benign prostate     hyperplasia (BPH) in the transitional zone makes it difficult to locate tumours. Therefore,     there is a risk of missing a significant cancer or an incorrect grading of the tumors     aggressiveness (Gleason score) by TRUS-bx. Thus, 10 systematic biopsies are not always     representative of the whole gland. In addition, many men only harbour small in-significant     cancer foci, that will never cause patient morbidity or mortality. It is often best not to     detect these small insignificant tumour foci due to the risk of overtreatment.      If MRI was performed before any decision to biopsy was made, some patients might not be     diagnosed with insignificant PCa since MRI mainly finds significant cancers. The     Multiparametric Magnetic Resonance Imaging (mp-MRI) seems to be more accurate in detection     and localization of PCa according to clinical studies and several studies have shown that     mp-MRI is able to distinguish between patients with significant and insignificant PCa. As     mp-MRI visualizes the whole gland it can identify suspicious cancerous regions and be used as     a guide for targeted biopsies. Also, this has the potential to decrease the number of     biopsies as the 10 standard biopsies can be replaced by 1-4 MRI targeted biopsies.     Furthermore, some patients might not need biopsies at all if the MRI does not show any     suspect foci, thereby decreasing the risk of complications from the biopsy-procedure.      In theory mp-MRI could be used to determine which patients need to be biopsied and which do     not - a sort of screening tool. The current standard examination takes about 45-60 minutes.     This is too long and too costly for a screening procedure. Based on the investigators three     year long experience, they have chosen two scanning sequences and one calculated sequence,     which they believe can answer the question: Is significant cancer present or not? This is the     biparametric-MRI (bp-MRI) which takes only 20-25 minutes and does not involve administrating     any MRI standard drugs. The chosen sequences are: T2-weighted (T2W) images in the axial     plane, diffusion weighted (DWI) axial images with multiple b-values and calculation of the     apparent diffusion coefficient (ADC)-map. If, on the other hand, if MRI is to be used for     staging purpose, six sequences are needed: T2W images in 3 planes (axial, coronal and     sagittal), DWI axial images with multiple b-values plus calculation of apparent diffusion     coefficient (ADC)-map and Dynamic Contrast Enhancement (DCE) T1-weighted (T1W). This is     called a multiparametric MRI (mp-MRI).      The two T2W sequences in the coronal and sagittal planes can be left out because they mainly     add information for staging purposes. The hypothesis is that these two are not necessary, as     the investigators only want to determine whether there is sign of significant cancer or not.     Neither is the DCE using contrast medium necessary because it only indicates whether     post-biopsy-blood is present or not which is not the case in this patient group. The bp-MRI     will be less detailed, but most details are not important when using MRI for PCa detection     only. Studies show that the ADC-map calculated from DWI correlates with the Gleason score and     may be used as a non-invasive measure for cancer aggressiveness.      In summary, the bp-MRI is designed only to determine whether significant cancer is present or     not, and will not be able to assess the stage of the cancer (extension through the capsule or     invasion into the vesiculae seminalis or urethra/bladder neck). As previously stated, half of     the patients that are referred due to suspicion of PCa do not have PCa and there is no need     for them to undergo the normal mp-MRI scan. In case of a high-risk patient (>cT2b, Gleason     score >7 and PSA >20 (group 2)) staging is necessary and because of that a normal mp-MRI will     be performed.   "
53587|NCT02584166|"     This cluster-randomised controlled trial will test the hypothesis that a multifaceted program     with psychological intervention in morbidity mortality conferences (MMC) improve care quality     and reduce the rate of morbidity mortality perinatal in diverse obstetric care settings.   "
53662|NCT02583178|"     The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation     System in accessing and closing off the left atrial appendage (LAA) using a minimally     invasive epicardial access approach.      A minimum of 30 participants will be included in this study, which is being performed at a     maximum of 8 centers in Canada and the United States. (A maximum of 5 participants at 4 US     centers will be enrolled)      Participants will be considered for this treatment if their doctor(s) have determined they     have documented non-valvular atrial fibrillation and are at increased risk for developing a     stroke.   "
53588|NCT02584153|"     Incisional hernias are a frequent consequence of abdominal surgery. Current clinical efforts     are primarily focused on improving repair materials and surgical techniques to correct these     hernias instead of the optimal solution: prevention.      A product called MYOSEAL is currently being developed to prevent hernia formation after     abdominal surgery by using fibrin tissue sealant and silver particles to prophylactically     enhance the early wound healing of myofascial incisions. The purpose of this phase 1 study is     to examine the safety of applying MYOSEAL immediately after abdominal wall suture closure in     patients undergoing abdominal surgery. The investigators expect that applying this product to     sutured myofascial incisions will increase collagen formation in the wound and thus prevent     the formation of incisional hernias.   "
53589|NCT02584140|"     The purpose of this study is to test a program that uses drug level monitoring, text     messaging (iTAB) and personalized counseling with HIV prevention services, including PrEP     (medicine that can help prevent HIV infection when taken daily).   "
53590|NCT02584127|"     The study evaluates the effectiveness of an internet-based smoking cessation program for     Korean Americans.   "
54052|NCT02578082|"     This multiple-center, nonrandomized, open label, parallel group, single dose study will be     conducted in male and female subjects with normal renal function or severe (eGFR <30     mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the     pharmacokinetics (PK) of TD 4208.   "
53591|NCT02584114|"     Background: People with psychosis show profound deficits in memory. A new cognitive     remediation therapy using an app on a computer or mobile phone to improve memory has been     effective in this population, but the neurobiological effects are unknown.      Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes     during a working memory task before and after a 12 hour memory training intervention on a     computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter     connecting prefrontal and parietal lobe before and after training.      Methods: 46 people with psychosis will be randomized to a computerized training of either     memory training or a control condition of non-memory games (language/card games) and will     self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total).     Memory training will be done with the Peak app http://www.peak.net. Imaging data will be     gathered with a 3 Tesla scanner pre and post training.   "
53592|NCT02584101|"     Background: Research has extensively documented the adverse impact that caring for an     individual with an acquired brain injury can have including financial difficulties, social     isolation, family tension and conflict, relationship difficulties, role adjustment and     psychological distress (Foster et al., 2012). Research has indicated that Acceptance and     Commitment Therapy (ACT) shows promise for increasing wellbeing and psychological flexibility     in caregivers and could be a useful intervention for use with this population.      Aims: The primary aim of this study is to investigate the feasibility of using an ACT     intervention to enhance the wellbeing and the psychological flexibility of carers using the     Population, Intervention, Control, and Outcomes (PICO) framework. Methods: The current study     is a randomised control design, exploring the feasibility of comparing the efficacy of an ACT     intervention to Enhanced Treatment As Usual (ETAU), to improve the wellbeing of the carers of     adults with an acquired brain injury (ABI). Participants will be recruited from the Brain     Injury Rehabilitation Trust (BIRT) in Glasgow, Scotland and randomly assigned to either an     ACT intervention group or TAU control group. Both will be assessed in parallel to one another     completing a range of baseline and post-baseline measures. Applications: This feasibility     study will provide information for further research on the utilisation of an ACT intervention     to improve the wellbeing of carers and whether this is an acceptable intervention for this     population.   "
53593|NCT02584088|"     -  The study primarily aims to evaluate the post ablative endometrium and uterus using          transvaginal ultrasound to provide descriptive information as to what may be expected in          the 12 months after a NovaSure ablation. Investigators believe this knowledge will help          them to determine when to proceed with further evaluation postoperatively or when to          counsel patients on expectant management based on ultrasonographic findings.        -  Secondary aims include correlation of ultrasonographic findings to demographic patient          data.   "
53594|NCT02584075|"     Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular     disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell     located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin     release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and     prevent vascular from atherosclerosis. Investigators design this study to investigate     exenatide's effect on the improvement of the coronary endothelial function by evaluating     endothelium dependent diastolic function and testing the vascular endothelial active     substance and related inflammatory factors.   "
53595|NCT02584062|"     The purpose of this study is to observe the technologic application of no-touch fluid-air     exchange in Surgery of Idiopathic Macula Hole.   "
53596|NCT02584049|"     The purpose of this study is to evaluate effects of Osteopathic Treatment in the Management     of Care-induced pain in Elderly care, in Follow-up care and Rehabilitation Geriatric.      The investigators assume that the application of a procedure based on osteopathic fascial     techniques in elderly care in Suite and Geriatric Rehabilitation ( SSRG ) suffering from pain     of nursing care, could reduce the painful phenomenon having systemic action, and improve     tissue engineering, trophicity viscera and the neurovascular supply .   "
53597|NCT02584036|"     The primary objective of this study is to evaluate how implementing an innovative care model     that provides the pharmacist access to a patient's vaccine history at the point-of-care     impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination     rates for routinely recommended adult vaccinations.   "
53598|NCT02584023|"     Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be     beneficial in mechanically ventilated infants compared to those who did not receive lung     ultrasound and alveolar recruitment maneuver.   "
53599|NCT02584010|"     This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective     in the treatment of postoperative scars.   "
53600|NCT02583997|"     The main objective of this study is to evaluate postoperative pain (measured by visual     analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom     teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a     similar group of patients undergoing standard care (suturing for lower alveoli).   "
53663|NCT02583165|"     To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced     solid tumors   "
53601|NCT02583984|"     Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and     mortality after lung resection. One-lung ventilation (OLV) is usually required in thoracic     surgery. OLV is also an important predictor of postoperative ALI. Recent laboratory findings     suggested that tissue hypoxemia and ischemia / reperfusion injury of the collapsed lungs     during OLV is the major cause of lung injury. Exhaled Breath Condensate (EBC), which is the     exhalate from breath typically collected by cooling device, contains most molecules found in     the airway. Metabolomics refers to systematic and scientific study of chemical processes     involving metabolites. This study will collect EBC for metabolomic analysis and aim to     elucidate the biochemical reactions during one-lung ventilation and pathological mechanisms     of acute lung injury following thoracic surgery.   "
53602|NCT02583971|"     Investigators will assess the impact of treatments for atrial fibrillation on participant's     thrombotic status   "
53603|NCT02583958|"     Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local     treatment of venous or mixed leg ulcers: a European, randomised clinical trial.   "
53604|NCT02583945|"     Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in     patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes     (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A     protocol for the improvement of the hemodynamic situation and a standardized proceeding in     hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement     of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if     the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI     in patients at risk after non-cardiac surgery.   "
53605|NCT02583932|"     To test whether the Meaning-Making intervention (MMi)(Lee, 2004) plus usual care increases     the sense of meaning in life in people newly diagnosed with any type of advanced cancer,     compared to similar people who receive 1) usual care alone or 2) usual care plus visits from     an empathic visitor, at 2 months after randomization to one of these treatments. The     investigators will also evaluate whether any effect is present at 4 and 6 months     post-randomization, and the MMi's impact on anxiety/depression, quality of life, existential     wellbeing, and posttraumatic growth. To answer our research questions 471 newly diagnosed (<6     months) advanced cancer patients (stages III or IV) will be studied.   "
53606|NCT02583919|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of     ISIS-GCGRRx in combination with metformin versus placebo   "
53607|NCT02583906|"     Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH     (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension)     patients suffering from sleep disordered breathing.   "
53608|NCT02583893|"     This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow     samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone     hydrochloride, etoposide, and cytarabine [MEC]) in patients with acute myeloid leukemia (AML)     that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the pathway     that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help improve     patient response. Studying samples of bone marrow from patients treated with sirolimus in the     laboratory may help doctors learn whether sirolimus reverses or turns off that pathway and     whether changes in biomarker levels can predict how well patients will respond to treatment.   "
53609|NCT02583880|"     This is a survey which will be performed on a specific day (the Screening Day) in Latin     American ICUs.      In eligible patients who receive enteral or parenteral nutrition a retrospective calculation     of the caloric deficit will be performed. The caloric deficit is the difference between     energy target of each patient and actually administered calories.   "
53610|NCT02583867|"     50 subjects with Major Depressive Disorder who are not currently receiving treatment will be     enrolled in a 12-week exercise program, supervised by a trained exercise interventionist.   "
53611|NCT02583854|"     The transradial route is used in 90% of the coronary angiograms performed at Oslo University     Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to     achieve hemostasis. Patients and staff will benefit from using a device that yields safe and     painless hemostasis.      Patients will be randomly assigned to receive either the standard compression device (control     group, A) or a recently developed compression device (experimental group, B). The study will     be designed as a non-inferiority, prospective randomized controlled trial, with outcome     measures being patient comfort during compression time and complication rates. Complications     that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow     up visit. Hematomas or bleeds from the puncture site after application of the compression     device will also be classified as complications.      The aim of the study is to investigate whether the new device, RY-STOP is non-inferior     compared to the standard device, when considering the outcome measures.   "
53612|NCT02583841|"     Aim:      To evaluate effect of non- surgical periodontal therapy on liver function in systemically     healthy chronic periodontitis (CP) subjects.      Materials and methods:      The study is non surgical interventional trial, includes 50 CP subjects in the age group of     35- 60 years selected from the OPD (Out Patient Department) of department of periodontology     Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were     equally divided into test group and control group. Liver function test- aspartate     aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1     month after treatment. Clinical examination includes plaque index, gingival index, sulcus     bleeding index, probing depth, clinical attachment loss.   "
53613|NCT02583828|"     This is a randomized clinical trial to investigate the efficacy of letrozole combined with     metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.   "
53614|NCT02583815|"     This is an open label feasibility pilot study of commercially available physical activity     monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer     Center, UT Southwestern Medical Center.   "
53664|NCT02583152|"     Mucopolysaccharidoses (MPS) are currently treated with Enzyme replacement therapy and Bone     Marrow Transplantation (BMT). No current evidence on the effectiveness on these therapies on     the eye in this systemic disease is avalible. Using new imaging techniques; previously     subjective data can be quantified and compared to determine if there is an improvment in the     vision of patients with MPS.   "
53651|NCT02583321|"     Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in     patients under mechanical ventilation could be questionable. Whatever the hypothetical     mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated     Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the     cornerstone of this potential side effect of the routine oral care with chlorhexidine     gluconate. The DEMETER study assessing the medico-economical impact of the subglottic     secretions drainage study (NCT02515617) provides the opportunity to perform this proof of     concept study (detection of chlorhexidine in tracheal secretions after routine oral care with     chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on     this potential detection of chlorhexidine.      This ancillary study will be performed in one of the centers participating to the DEMETER     study.   "
54053|NCT02578069|"     Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting     stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology     centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.   "
53615|NCT02583802|"     This clinical study is to observe the improvement of MHD (maintenance hemodialysis) patients,     quality of life，after applying therapy combining Auriculotherapy and Shengmai capsule. As a     compliment to each other, Traditional Chinese Medicine and Modern Medicine form a joint and     help improving life quality of MHD patients. Through the therapy, MHD patients, symptoms of     thirst are improved, the incidence of intradialytic hypotension is reduced, the intake of     water and sodium is lessen and the weight gain during dialysis is controlled, which     consequently reduce cardiovascular and cerebrovascular complications and eventually reduce     the mortality of MHD patients. Aiming to improve patients, thirst symptom and reduce the     incidence of intradialytic hypotension, this study prospectively followed 144 MHD patients     using multicenter prospective randomized crossover controlled clinical studies, using KT/V,     URR, improvement of thirst, blood pressure and cognitive assessment as observational index.     Multiple questionnaire surveys are conducted to understand patients, life quality from     different angle. The use of Auriculotherapy is simple and effective and Shengmai capsule     conforms to patients, syndrome, which is consistent with TCMs principle of syndrome     differentiation and treatmentand the theory of preventive treatment. The study not only     expends the use of TMC in hemodialysis treatment, but also suggests a set of easy therapeutic     schedules to improve the quality of life in patients receiving hemodialysis treatment.   "
53616|NCT02583789|"     This study represents the first trial to assess the efficacy of oral treprostinil therapy in     patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to     vasodilatory therapy.      The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all     subjects will be randomized to receive oral treprostinil sustained release tablets or     matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed     for 12 weeks of treatment with oral UT-15C during the study.   "
53617|NCT02583776|"     Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes     in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by     capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes     in preterm newborns.      The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain     euglycemia (defined as a target value 72-144mg/dl) in VLBWI.      It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within     48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4     Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to     CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be     active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily     capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be     evaluated with the validated Premature Infant Pain Profile (PIPP) scale.      The estimated numerosity is 50 patients (25 for each arm).   "
53618|NCT02583763|"     The aim is to increase awareness of the relationship between (IUGR) and cardiac function in     the foetus, the development of cardiac function over time after delivery and what     significance a possible early disturbed myocardial function have for the neonate and the     child during the first years of life.   "
53619|NCT02583750|"     This project investigated how glucose metabolism differs due to sleep deprivation for three     consecutive nights as compared to sufficient sleep for three nights by examining     concentrations of glucose, insulin, and other factors involved in glucose metabolism.   "
53620|NCT02583737|"     Bone resorption and atrophy in maxillary posterior region is due to severe periodontal     disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth     extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a     great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and     many biomaterials have been used to solve filling issues to maintain the sinus floor lifted     in a position that can allow dental implants installation. Bone grafts have shown to be the     best choice of filling grafts. Despite autologous bone are the gold standard filling     biomaterial it is associates with great mortality and morbidity. So, bone allografts from     tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue     bone are the most common allografts but literature is poor in randomized controlled parallel     clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to     perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and     freeze bone allografts from human bone tissue bank. The investigators want to verify which     one can develop greater osteogenesis, if is there any difference between them regarding the     architectural trabeculae formation, if there are different patterns of reabsorption and     finally if is there any differences between them regarding primary and lately dental implants     stability. To answer those questions the investigators propose firstly, to carry out     microtomographic and histological analysis from trephine bone samples after six months of     sinus lifting and grafting in healthy participants undergoing osseointegrated dental     implants. Secondly, the primary and lately implant stability is going to be achieved     employing Resonance Frequency Analysis (RFA).   "
53621|NCT02583711|"     This is an observational study, which aims to assess how physical activity levels following     surgical procedures correlate with patient recovery and length of hospital stay, as well as     the utility of this physical activity data to the postoperative surgical team. Surgical teams     frequently enquire about their patients' physical activity levels on postoperative ward     rounds. Although this information is often provided anecdotally by nursing staff and junior     doctors, there are no objective data made available to the clinician. Such data has the     potential to supplement other observations (e.g. heart rate, blood pressure, temperature) to     help gain an impression of a patient's recovery and physical status, this in turn could     provide evidence to help facilitate early discharge as well as to predict medium to longterm     outcomes. Advances in wearable technology allow the investigators to collect detailed     information with regard to activity with minimal disruption.      Recent literature has shown that these wristworn sensors can feasibly be worn in hospital pre     and postoperatively, with evidence of a correlation between the amount of steps taken     postoperatively and the length of hospital stay. This study will provide further evidence for     the usability and utility of wearable sensors in the inpatient surgical setting. It will     provide supporting evidence for surgeons to confidently analyse and assess patients in     hospital, allowing for safe and expedient discharge home as well as identify highrisk     patients who are likely to require extra support and surveillance in the community setting.   "
53626|NCT02583646|"     Background:      Studies suggest that overweight girls may be developing breast tissue, and therefore starting     puberty, earlier than normal weight girls. However, it is hard to distinguish breast tissue     from fatty tissue. Researchers think that by using breast ultrasound, among other tests, they     can do a better job of telling whether an overweight girl has breast tissue. This will help     them understand if overweight girls are truly entering puberty before normal weight girls.      Objective:      To find out if overweight girls go through puberty earlier than normal weight girls.      Eligibility:      Healthy girls 8-14 years old who:        -  Are normal weight or overweight        -  Have some breast development        -  Have not started their first period      Design:      Parents of participants will be screened over the phone.      Most participants will have 1 visit. However, they can choose to have multiple visits within     4 weeks. The visit will include:        -  Physical exam that includes examination of the breasts and genital area        -  Breast ultrasound: A small hand-held device will be passed back and forth over the          chest. It uses sound waves to create a picture of the breast tissue.        -  Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower          belly. It uses sound waves to create a picture of the ovaries.        -  Urine and blood test        -  A special x-ray called a DXA to measure the amount of fat in the body: The participant          will lie still on a table while the x-ray takes pictures of the body.      X-ray of the hand: The picture will tell researchers how mature the participant s bones are.      Participants may be asked to come back 6 months later to repeat these tests.   "
53627|NCT02583633|"     One of the important complications of pregnancy is preterm labor (PTL) and delivery. There     are different tocolytic agents to enhance the time of delivery. The aim of this study was to     compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral     nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted     with diagnosis of PTL. Group one have received transdermal GTN whereas group two have     received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as     gestation age at the time of delivery have been monitored and evaluated in both groups of     patient. Our main goal has been delay of delivery to have the most beneficial effect of     primary corticosteroid administration for fetus.   "
53628|NCT02583620|"     Compelling evidence of genetic components in high myopia has been put forward by several     studies. Twin cohorts, familial linkage studies and population studies has described at least     10 loci containing genes involved in the disease development. The investigators previously     demonstrated novel linkage on chromosome 7q36 and chromosome 7p15 in French families. A new     approach consisting of a case-control based population association study is underway in order     to recover a high number of myopic subjects avoiding the limitation of familial cases. 1.8     millions polymorphic markers will be compared with emmetropic controls in order to recover     loci associated with the disease in the population.   "
53629|NCT02583607|"     Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the     most sophisticated methods of breast reconstruction is using of autologous fat grafting.     Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final     results of fat grafting.   "
53630|NCT02583594|"     Primary Objective:        -  To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab          administered by subcutaneous injection and 2 treatment courses of alemtuzumab          administered by intravenous infusion in patients with progressive multiple sclerosis.      Secondary Objectives:        -  To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous          injection or intravenous infusion to patients with progressive multiple sclerosis.        -  To characterize the safety and tolerability of alemtuzumab administered by subcutaneous          injection or intravenous infusion to patients with progressive multiple sclerosis.   "
53631|NCT02583581|"     This study evaluates the use of brain activity monitoring for prediction of migraine attacks     in an expected time scale of 12-48 hours prior to the migraine attack.   "
53632|NCT02583568|"     A need for further investigation for fluorescence image-guided surgery in breast conserving     surgery (BCS) has arisen following the results obtained from a phase I feasibility breast     cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the     optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation     of breast cancer tissue using the improved and optimized fluorescent tracer and camera     system.   "
53633|NCT02583555|"     The purpose of this study is to identify persons with high risk of frequent hospital     admissions and by counselling by one in depth interview followed by frequent telephone     contacts improve their quality of life and reduce their healthcare utilization.   "
53634|NCT02583542|"     Selumetinib (AZD6244) and AZD2014 are two new anti-cancer treatments that AstraZeneca are     developing; they are both not yet approved for clinical use.      Selumetinib (AZD6244) is a drug that acts by blocking a protein called MEK, which has been     linked to the development and growth of multiple cancers. AZD2014 is a drug that blocks a     protein called mTOR that is involved in the growth and spread of cancer. Blocking the action     of either MEK or mTOR alone may slow down or stop the cancer growing. Combining both drugs     may make the cancer more sensitive than if Selumetinib (AZD6244) or AZD2014 are used alone     and therefore this dual treatment may lead to increased anti-tumour effects.      Although Selumetinib (AZD6244) and AZD2014 given alone and in combination with other     anti-cancer drugs have been tested in people with advanced cancer, the specific combination     of Selumetinib (AZD6244) and AZD2014 has not been used in people before. Therefore Phase 1b     (Dose Escalation Phase) will determine what the recommended dose to use in Phase IIa (Dose     Expansion Phase) will be. Efficacy, progression free survival, duration of response, and     overall survival, will then be assessed in patients with triple-negative breast cancer, and     Non small cell lung cancer within Phase IIa.   "
53635|NCT02583529|"     Dysfunctions of the lower urinary tract are non-motor symptoms common engines in Parkinson's     disease (PD). Urodynamic changes in PD include overactive bladder (OB), characterized by     urgency with or without urge incontinence , usually with frequency and nocturia . The aim of     this study is to evaluate the efficacy and effectiveness of the treatment of OB in patients     with PD with the use of a specific treatment: Posterior Tibial Nerve Electrostimulation     (PTNE).   "
53665|NCT02583139|"     The purpose of this study is to determine whether a specially-designed music-narratives are     effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.   "
53637|NCT02583503|"     When carrying out a knee replacement operation one of the goals is to correct any deformity     of the leg (bowlegged or knock kneed). The ideal alignment is the mechanical axis, which is a     line from the centre of the hip joint to the centre of the ankle. This line indicates how the     weight of the body is transmitted to the ground via the leg. Often the planning for a knee     replacement uses an Xray which shows the hip, knee and ankle (HKA Xray) so that the     mechanical axis can be drawn on.      However, the weight of the body goes to the ground from the ankle through the heel. There     have been some reports recently suggesting that deformities in the heel can influence the     overall leg alignment after a knee replacement; this may affect how successful the surgery     is, or how long the knee replacement will last. Therefore it may make sense to take the     alignment of the leg including the heel in planning for a knee replacement.      The conventional practice to assess the alignment of the heel is a hindfoot alignment view     (HAV) Xray. This only shows the foot. Having two separate Xrays means more radiation exposure     and makes linking the two alignments very difficult. We propose a single novel Xray extending     the HKA Xray to shows hip, knee, ankle and heel (HKAH Xray) enabling measurement of both     alignments.      This study is to validate the hindfoot alignment seen on the novel Xray with the standard     HAV. Patients undergoing a knee replacement will be enrolled. Patients will have both a HKAH     and HAV Xray before surgery. The alignment of the heel measured on the HKAH Xray will be     compared with the standard HAV to see if it is accurate.   "
53638|NCT02583490|"     This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse     Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional     unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality.     The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia     Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible     participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT,     or conventional RUL ECT.   "
53639|NCT02583477|"     A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different     Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal     Adenocarcinoma   "
53640|NCT02583464|"     Objective: To evaluate the relative bioavailability of a new formulation containing a     combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare     this formulation with the branded formulation (R) to meet regulatory criteria for marketing     the test product in Argentina.   "
53641|NCT02583451|"     This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study     of lemborexant in healthy adult and elderly subjects to evaluate driving performance   "
53642|NCT02583438|"     The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The     researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in     patients with newly diagnosed type 2 diabetes.   "
53643|NCT02583425|"     Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache   "
53644|NCT02583412|"     The overall aim of this study is to determine if an accelerated Bexsero® (Multicomponent     meningococcal B vaccine) schedule compared to a standard schedule is immunogenic, safe, and     tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no     formal hypothesis is tested.   "
53645|NCT02583399|"     The primary objective of this study is to evaluate the pharmacokinetic profile of a single     dose of intravenous ibuprofen administered over approximately ten (10) minutes.   "
53646|NCT02583386|"     The purpose of this study is to examine whether an exercise and educational classroom program     can help reduce falls in people with Multiple Sclerosis who fall frequently.   "
53647|NCT02583373|"     The objectives of this study are to assess the safety, tolerability, clinical and     microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by     Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of     standard of care antibiotic treatment.   "
53648|NCT02583360|"     The purpose of the investigator's study is to evaluate the causes of feeding difficulty in     infants. New treatments can be possible only if the cause is known. In this study, the     investigator plans to evaluate the movement of the muscles in an infant's mouth, throat     (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the     stomach and that help protect an infants airway.   "
53649|NCT02583347|"     Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is     reported in up to 50% of patients treated with hemodialysis compared to 12% of a control     population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been     described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD     have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional     hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients     with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep     quality. Transplantation is thought to improve sleep-related disorders in some but not all     patients.      Project Aims      The aims of this project were three-fold:        1. To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD        2. To assess the feasability and tolerability of unattended home PSG and wrist actigraphy          as diagnostic tools in this cohort        3. To assess the impact of a change in RRT modality on sleep quality in Irish patients with          ESRD   "
53650|NCT02583334|"     Fibromyalgia is the second most common autoimmune rheumatic diseases with clinical     manifestations of widespread pain, fatigue and accompanied cognitive and emotional     disturbances. It often associated with sleep disorders and headaches. The cardinal symptom of     fibromyalgia is widespread pain. Clinical observations reveal that pain in patients with     fibromyalgia could not simply improve by using analgesics only. Patients often use Chinese     medicine or acupuncture to help them to ease the pain.      The aim of this study is to investigate the efficacy of acupuncture in patients with     fibromyalgia. The study adapted a randomized, assessor- and participant-blinded,     sham-controlled, and parallel-design approach to investigate whether acupuncture can improve     the clinical symptoms and quality of life as well as the mechanism through laboratory     biochemistric and image study.   "
53666|NCT02583126|"     The purpose of this study is to determine whether a modified and resource-oriented form of     Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in     teenagers with cancer.   "
53652|NCT02583308|"     Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to     reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis     of VAP is widely considered as subjective and prone to both false-positive and false negative     assignments. In ths way, the impact of SSD remains controversial and its use limited in     Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the     subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the     dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation     would reinforce the results observed during the DEMETER study in considering the adjudicated     VAP incidence.      This ancillary study will be performed in 14 centers participating to the DEMETER study   "
53653|NCT02583295|"     Awareness during anesthesia with intraoperative memory occurs when the patient is able to     process information and produce specific responses to several stimuli. Anecdotal evidence     suggests that children exposed to therapeutic suggestion consisting of gently encouraging,     positive words spoken to them during emergence from anesthesia seem to arouse after surgery     with less agitation, less pain and lower requirements for pain medications. Therapeutic     suggestion has been associated with positive results in some adults during surgery, but it is     unknown how therapeutic suggestion affects children. A newborn's recognition and preference     for their mother's voice occurs early in life, very likely during fetal development.     Additional evidence, revealed that at least as early as 4 months of age, infants process     auditory stimuli from their mother's voice at a higher amplitude than they process auditory     input from female strangers, suggesting that maternal voice stimuli undergo a unique form of     cerebral processing that lends support for the existence of neurophysiologic mechanisms that     reflect a child's preference for his/her mother's voice. This study aims to evaluate and     compare the possibility of intra-operative awareness prevention by using either music     listening or maternal sound listening in children undergoing cardiac surgery.   "
53654|NCT02583282|"     Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently     heralds a poor prognosis.If the underlying malignancy is chemo sensitive (e.g., small-cell     carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion.     Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for     the management of MPE. According to a recent survey, tetracycline or its derivative     (doxycycline) is the preferred agent for performing pleurodesis at many centers. In a     previous study from the investigators' center, the investigators have demonstrated equal     efficacy of iodopovidone in comparison to talc in inducing pleural symphysis. Also,     iodopovidone has been postulated to have anti-neoplastic effects and hence may help in     reducing the drain output. Apart from these benefits iodopovidone is easily available and is     cost effective. The investigators believe that iodopovidone will have better efficacy than     doxycycline in inducing pleurodesis in malignant pleural effusion.   "
53655|NCT02583269|"     This phase I trial studies the side effects and the best dose of muscadine grape skin extract     (MGE) in treating patients with malignancy (tumor or cancer) that has spread to other parts     of the body or cannot be removed by surgery. MGE is a nutritional supplement containing an     extract of the skin of muscadine grape that has shown anti-cancer activity in laboratory     studies and may be able to fight or kill malignant cells.   "
53656|NCT02583256|"     Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared     to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial     V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.   "
53657|NCT02583243|"     Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services     Administration (SAMHSA) to increase treatment to opiate dependent patients with mental     illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care     for as long as the individual takes buprenorphine to track the success of buprenorphine for     the maintenance of opiate dependence.   "
53658|NCT02583230|"     The goal of this project is to develop and pilot a mobile smartphone delivered intervention     that will improve antidepressant medication care by providing medication adherence monitoring     and support to the patient, feedback on patient adherence and response to treatment to the     primary care team, and information to both patients and providers on guideline-congruent care     personalized to the patient's response to antidepressant medication.   "
53659|NCT02583217|"     Laryngeal mask airway is a common tool for airway management during anesthesia in many     surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile     hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to     compare the insertion conditions of laryngeal mask by using ketamine+propofol versus     remifentanil + propofol.   "
53660|NCT02583204|"     The study compares three strategies to prevent/minimise nail problems occuring in women, with     breast cancer, undergoing Taxane chemotherapy. The strategies are: application of nail polish     and normal care; application of Onicolife drops and normal care and; normal care only.   "
53661|NCT02583191|"     The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the     treatment of VTE in cancer patients in comparison to the standard treatment with low     molecular weight heparin (LMWH).      Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to     receive either Rivaroxaban or the standard treatment with low-molecular heparin.   "
54355|NCT02574130|"     The purpose of this study is to determine the cure rate from ventilator-associated pneumonia     (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to     intravenous antibiotics compared to intravenous antibiotics alone.   "
53670|NCT02583074|"     Primary cranial-cervical dystonia is managed mainly by repeated botulinum toxin     injections.This study is to establish whether subthalamic nucleus neurostimulation could     improve symptoms in patients not adequately responding to chemodenervation or oral drug     treatment. Investigators compared this surgical treatment with sham stimulation in a     randomized, controlled clinical trial.   "
53671|NCT02583061|"     In this prospective observational cohort study, women representing the full spectrum of     gestational glucose tolerance status are undergoing longitudinal cardiometabolic     characterization at regular intervals in the years after the index pregnancy.   "
54416|NCT02573337|"     The purpose of this study is to evaluate the perception of facial expressions following     correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and     Emervel Deep Lidocaine.   "
53673|NCT02583035|"     There are no recommendations and few studies on the monitoring of fragile patients in the     oncological treatment, both on the organizational arrangements on its interest in the     prevention of functional deterioration of the patient and adaptation of the potential cancer     treatment.      The oncogériatrique evaluation being time-consuming, requiring the movement of these more or     less frail elderly patients, it seems difficult to envisage repeated and systematic     standardized geriatric assessments during cancer treatment. Geriatric fragility can be     detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse     in patients treated for cancer, but with the aim to detect toxicities of cancer treatment,     patients are not very old (mean age 64.8 years).      External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric     oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.      However the telephone monitoring, with the aim to evaluate the evolution of geriatric     frailty, has not been specifically studied in the elderly population treated for cancer,     while taking oncology load.      The investigators wish to study the feasibility and validity of telephone follow-up which     could eventually be used routinely to identify patients requiring further medical     consultation oncogériatrique.   "
53674|NCT02583022|"     The study is a Phase II, single center, randomized, open-label, placebo-controlled study in     male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All     subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream     for up to 4 weeks.   "
53675|NCT02583009|"     This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic     confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028     cream 0.1%, 0.3% and 1.0% in patients with rosacea.   "
53676|NCT02582996|"     National clinical trials, phase III, randomized, open, parallel, study of superiority, in     which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65 years     will be randomly allocated to one of two treatment groups. The Group 01 will use Cefalium®     and group 02 will use Tylenol®.   "
53677|NCT02582983|"     This study assessed the safety and tolerability of enfuvirtide in participants with advanced     HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens     containing at least one product from each anti-retroviral class, or had experienced     intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg)     subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment     limiting toxicities and participants benefited from study treatment as per investigator's     discretion. The anticipated time on study treatment was based on the commercial availability     of enfuvirtide in Thailand, and the target sample size was 30 individuals.   "
53678|NCT02582970|"     This expanded access study will assess the efficacy and safety of intravenous (IV)     bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic     cancer of the colon or rectum. The anticipated median time on study treatment is     approximately 10 months, and the target sample size is 40 individuals.   "
53679|NCT02582957|"     A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive     mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease     the number of days they require invasive mechanical ventilation.   "
53680|NCT02582944|"     Despite technological advancements directed towards the diagnosis of peripheral pulmonary     lesions, an optimal approach has yet to be designed. The potential advantages of catheter     based techniques include the ability to utilize instruments smaller than the diameter of a     conventional bronchoscope, thereby allowing better access to the lung periphery. The     drawbacks of a catheter based approach include the relative inability to steer a conventional     catheter, and the inability to perform direct visualization and airway inspection through a     conventional catheter. This study will evaluate a novel steerable catheter system with     optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy     peripheral pulmonary lesions.   "
53681|NCT02582931|"     The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of     delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic     body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel,     integrated Co-60 MRI treatment machine. To best assess this technology, the investigators     will focus on patients that have no more than three sites of progressive disease within the     central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and     gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two     weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the     current standard of care but will allow adaptation based on daily anatomic changes. The     prescription dose will be determined based on hard normal tissue constraints, and capped at     10Gy per fraction. Although the long term goal will be to achieve improved local control and     disease-free survival with reduced toxicity, the present study will be driven by the short     term goal of demonstrating the feasibility of this novel treatment approach for recurrent or     metastatic ovarian cancer.   "
53693|NCT02582775|"     This is a single-institution, phase II study to determine the event-free survival at 1 year     post allogeneic transplant and serial mesenchymal stem cell (MSC) infusions from a related     donor (HLA identical, mismatched or haploidentical) or matched unrelated donor for the     biochemical correction of severe epidermolysis bullosa (EB).   "
53682|NCT02582918|"     Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic     randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC)     surveillance process completion among a socioeconomically and racially diverse cohort of     Texans with cirrhosis. Through this project the investigators will implement and evaluate     system-level mailed outreach interventions to identity at-risk patients with cirrhosis,     promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW)     Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs     (VA) Medical Center. The study population will include adult patients with documented or     unrecognized cirrhosis and at least one outpatient clinic visit in year prior to     randomization. Patients will be identified using an EMR-enabled case identification     algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this     algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or,     mailed HCC surveillance outreach with patient education and patient navigation services     (Group 2).   "
53683|NCT02582905|"     Preclinical and clinical data as well as mechanistic justification have been presented     suggesting citicoline and pregnenolone are each promising treatments for alcohol use in BPD.     Both appear to have favorable side effect profiles and no known drug-drug interactions. Thus,     they have the potential to be safely used in a dual diagnosis population already taking other     medications. A 12-week, randomized, double-blind, parallel-group, placebo-controlled adaptive     design study of citicoline and pregnenolone is proposed in 199 persons with alcohol use     disorder and bipolar I or II disorder, mood state currently depressed. The primary aim will     be to assess change in alcohol use. Biomarkers of alcohol use, alcohol craving, mood and     cognition will also be assessed. Relationships between neurosteroid and choline levels and     the outcome measures will be explored.   "
53684|NCT02582892|"     Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation     and remodeling.   "
53685|NCT02582879|"     The purpose of the InformCLL Registry is to characterize and describe treatment patterns for     those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other     approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment     patterns with patient characteristics, healthcare resource utilization and patient reported     Health related Quality of Life (HRQoL).   "
53686|NCT02582866|"     Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in     patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of     additional monotherapy safety data, and will facilitate access to treatment until commercial     availability for monotherapy use.   "
53687|NCT02582853|"     Guillain- Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy (AIDP)     that often is triggered by an infection. GBS is characterized by progressing weakness and     numbness and loss of tendon of reflexes. It can also include tingling sensation in the legs     and arms. These symptoms occur due to an autoimmune attack on the myelin resulting in     demyelination.      The diagnosis is given by electrophysiological examination and clinical presentation.      GBS is treated with intravenous immunoglobulin (IVIG) and plasma exchange (PE). Both     treatments are equally effective. Most patients recover completely, while others must ease     symptoms and reduce the duration of illness by several treatments.      The purpose of this study is to define if patients with GBS have higher concentrations of     sCD163 in their cerebrospinal fluid and serum compared with symptomatic control subjects.     Furthermore it is to define if the concentrations of sCD163 reduces after treatment.   "
53688|NCT02582840|"     This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will     enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate     glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit.     lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3     single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user     are excluded.   "
53689|NCT02582827|"     The primary objective of study CA601.2 is to determine the maximum tolerated dose (MTD) or     recommended phase 2 dose (RP2D) of ABI-011 when administered by intravenous (IV) infusion on     Days 1, 8, and 15, followed by a week of rest, in patients with advanced solid tumor     malignancies or lymphomas. The MTD will be determined using a standard 3+3 design. The     secondary objectives are to evaluate the safety and toxicity profile, to evaluate the plasma     pharmacokinetics (PK), to assess the biological activity and pharmacodynamics, and to make a     preliminary assessment of tumor response in patients with advanced solid tumors or lymphomas.     The exploratory objectives are to determine the genomic and proteomic profile of patients'     tumors to identify gene mutations, gene amplifications, levels of protein expression, and     pinpoint oncoproteins. Correlations between genomic/proteomic profiles and efficacy outcomes     will be assessed and principal metabolites of ABI-011 will be determined, if possible.      Approximately 45-60 patients will be treated to determine dose limiting toxicities (DLTs),     the MTD, and/or RP2D of ABI-011. Once the RP2D is identified, expansion of this cohort (up to     10 patients) will occur.   "
53690|NCT02582814|"     This study will enroll eligible subjects into a long-term safety study (Part B).      Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic     control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of     enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3     months prior to the screening visit. The study design of Part B is a randomized, open-label,     2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1     ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.   "
53691|NCT02582801|"     18F-Alfatide Ⅱ PET/CT in breast cancer patients   "
53692|NCT02582788|"     The current clinical guidelines for management of atopic dermatitis now recommend bleach     baths. This requires simply the addition of regular household bleach to twice-weekly baths.     At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet     wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has     not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic     acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as     well as, or better than, the current accepted guidelines?   "
70697|NCT02360397|"     The purpose of this study is to determine whether ranolazine has beneficial effects on     cardiac ischemia through reduction of premature ventricular contraction burden.   "
53694|NCT02582762|"     Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which     cause nail plates grow defectively. Common nail surface abnormalities are pitting nails,     longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail     surface abnormalities as well.      Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic     use is increasing with day by day, their usefulness in conditions such as nail biting,     brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported     the benefits of nail gels in terms of improving nail surface abnormalities like pitting     nails, trachyonychia, and onychoschizia.      This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has     humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities     in finger nail surface abnormalities.   "
54448|NCT02572921|"     This study evaluates the effects of the Positive Psychotherapy on depressive symptoms and on     happiness compared with regular cognitive behavioral therapy.   "
53696|NCT02582736|"     The purpose of this study is to determine whether the use of atypical antipsychotic     medication increases the risk of hospitalization for a hyperglycemic emergency.      The investigators will carry out separate population-based cohort studies using     administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry     will be defined by the initiation of a new antipsychotic medication. Follow-up will continue     until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from     the separate sites will be combined to provide an overall assessment of the risk of     hyperglycemic emergencies among new users of various antipsychotic drugs.   "
53697|NCT02582723|"     A double-blind, randomised crossover design will be employed with three experimental     conditions; High protein/high fat hard cheese, high protein/low fat hard cheese, and low     protein/high fat creme cheese served at least 7 days apart. After having successfully     completed screening procedures, eligible participants will be invited for three separate test     days. The test days should be performed at least 7 days apart; however for logistical reasons     4 days can be accepted. On the test days, the products will be provided in a randomized     order, and subjective appetite ratings will be measured every 30 minutes for the following 3     hours. Subsequent energy intake will be measured by an ad libitum meal 3 hours following     serving of the breakfast meal.   "
53698|NCT02582710|"     Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a     40% decrease in the average concentration of total microparticles (MPs) in the atheromatous     plaque.   "
53699|NCT02582697|"     The purpose of this study is to determine whether accelerated BEP chemotherapy is more     effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic     germ cell tumours.   "
53700|NCT02582684|"     This study is being done to see if the combination of two anti-HIV medicines, dolutegravir     (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, will provide a safe, effective,     and well-tolerated treatment for HIV. DTG is a type of HIV medicine called an integrase     inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works     by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins     (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the     blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended     regimens along with a third active drug. Since some HIV medicines have side effects and are     costly, there is interest in whether HIV can be successfully controlled with fewer than three     HIV drugs.   "
53701|NCT02582671|"     This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± RBV     in chronic hepatitis C virus infected participants across Ireland.   "
53702|NCT02582658|"     The study seeks to provide evidence of the effectiveness and obtain patient reported outcome     (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN +/- Ribavirin (RBV) in     chronic hepatitis C virus infected participants in Austria.   "
53703|NCT02582645|"     In this investigation the investigators would like to find out which of two commonly used     techniques of management of palatally impacted canines: closed-window (CWT) or open-window     (OWT), produces more favorable outcome.   "
53704|NCT02582632|"     This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and     dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis     C virus (HCV).   "
53705|NCT02582619|"     Spinal cord injury often results in complete or partial loss of functioning of the upper and     or lower limbs, leading to the affected individual experiencing difficulties in performing     activities of daily living. This in turn results in reduced participation in social,     religious, recreational and economic activities (employment). Globally, there is a low     employment rate (11-67%) amongst PLWSCI. In South Africa, according to Statistics South     Africa, the unemployment rate of people with disabilities is estimated to be 25.2%. However,     there is no information available on employment amongst PLWSCI in South Africa.      Furthermore, there is insufficient knowledge related to SCI in South Africa to enable a model     to be developed and implemented. Data on the current SCI rehabilitation practices (with     specific reference to vocational rehabilitation); employment status and factors (both     personal and environmental); barriers and facilitators of employment amongst PLWSCI is     limited. This information is needed to develop a return to work model for individuals with     SCI in South Africa.      In South Africa, a legal framework exists that promotes the employment as well as assistance     of people with disabilities in the workplace, such as: the Constitution of Republic of South     Africa, 1996; the Employment Equity Act (EEA), 1998; the Promotion of Equality and Prevention     of Unfair Discrimination Act (PEPUDA), 2000; Labour Relations Act (LRA), 1995; Skills     Development Act (SDA), 1998; Public Service Act (PSA), 1994; Basic Conditions of Employment     Act (BCEA), 1997 and the Integrated National Disability Strategy (2000). However,     rehabilitation interventions provided in rehabilitation institutions are mainly medical, with     limited attempts to prepare those with SCI to return to gainful employment. There is     therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and     multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in     South Africa.   "
53712|NCT02582528|"     The primary aim of the project is to test the effectiveness of a cognitive remediation     treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing     (MI) in improving cognition and functional outcome of individuals at risk of SMI. An active     control treatment consisting of CRT alone will be used. Hypotheses: 1. Both study groups will     have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased     treatment adherence and superior improvements in cognition at the end of treatment and 12     months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved     cognition will be associated with improved functional outcome.   "
55104|NCT02564354|"     Exploratory proof of concept study to determine whether intranasal administration of QR-010     in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation,     can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).   "
53736|NCT02582216|"     This study has two objectives. First, to introduce a new virtual reality method that     incorporates the mechanisms used in mirror visual feedback through a three-dimensional (3D)     augmented virtual reality system. Second, to evaluate the efficiency of this new method on a     convenience sample of patients presenting with unresolved neuropathic pain (CRPS, PLP,     plexopathy, stroke) who were not responding adequately to both pharmaceutical management and     traditional mirror therapy.   "
53890|NCT02580214|"     The aim of this pilot study was to investigate whether the use of a multimodal protocol of     preoperative care plus preoperative immune nutrition would decrease the length of stay and     acute phase inflammation in patients submitted to total hip arthroplasty (THA). The study was     designed to be randomized and controlled, but not double blind. The patients were randomized     to receive either preoperative care based on evidence plus immune nutrition for 5 days prior     to surgery (Acerto group) or traditional preoperative care (control group). Main endpoints     were length of stay and acute-phase postoperative response   "
53706|NCT02582606|"     In this study investigators will compare the health effect of two different meal patterns. In     one, participants will consume food according to an 'irregular meal pattern' (minimum 3     meals, maximum 9 meals per day) and in the other 'regular meal pattern' (6 meals per day) for     two weeks. The energy requirement of the participants will be calculated to maintain body     weight during the study. Participants will be provided with all the food to be consumed     during the study.      Initially, interested individuals will attend a screening visit in which they will complete     questionnaires on medical health, eating habits and physical activity. Height, weight and     waist circumference will be measured at this visit. Thereafter, participants will be assigned     to a 2-week period following one of the two meal-patterns. There will be a 2-week period     between the two interventions when they will consume their normal diet and at the end of     this, participants will undertake the next meal pattern. During the two phases participants     will be asked to wear an armband (which detects movement and measures heat loss), to assess     their energy expenditure and an interstitial glucose monitoring device will be worn for seven     days. Before and after each 2-week intervention, participants will come to the laboratory for     a mixed-meal tolerance test. Blood samples will be obtained before and for 3hrs after eating     to evaluate the health effects of the meal patterns. Energy expenditure will be measured by     ventilated-hood indirect calorimetry and the armband device. At the end of the 3hr post     prandial period, participants will be offered an ad libitum pasta lunch and be asked to eat     until they feel comfortably full.      During each of the 2-week periods, participants will be asked to record their food intake and     record their appetite sensations on specific days.   "
53707|NCT02582593|"     Changes in mood and cognition are common in older adulthood. Some studies have suggested that     transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive     and mood status in young adults and individuals with traumatic brain injury. This effect has     not been examined in older adults. This study will involve a randomized sham-controlled trial     to learn whether NIR stimulation improves cognition and mood in older adults, relative to     sham treated controls.   "
53708|NCT02582580|"     Perineal trauma during childbirth is an important etiological factor of various undesirable     complications to women's health, with emphasis on pelvic floor dysfunction. Thus, methods     that preserve the perineal integrity have been a challenge to practices among health     professionals working in the gravid-puerperal cycle assistance. Despite the remarkable     importance of beneficial effects of pelvic floor preparation prior to vaginal birth on     prevention of perineal trauma, there are few studies in the literature that point which is     the best method to be used to reduce the chances of perineal lesions. Therefore, there is     need for more studies to compare existing methods. The objective this present study is to     compare the effects of perineal massage, the vaginal dilator and training of the muscles of     the pelvic floor to prepare the pelvic floor for vaginal birth on perineal integrity of     primiparous. Primigravidae women are selected over 18 years, from the 32th gestational week     and wishing to have a vaginal birth. Women will be randomly allocated into 3 groups: perineal     massage, vaginal dilator and pelvic floor muscles training and should practice the technique     from the 34th week of pregnancy until the time of delivery. All the women will be subject to     clinical evaluation, functional assessment of pelvic floor and perineal integrity assessment     prior to the beginning of the practice of the technique and between 45 and 60 days after     childbirth.   "
53709|NCT02582567|"     The main objective of this project is to assess the effects of a novel and supervised     exercise intervention in overweight pregnant and their newborn.      Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant     interested in participate in the intervention program will be randomly assigned to either     exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The     primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic     profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii)     physical fitness; iv) objectively measured physical activity and sedentary behaviour; v)     sleep quality; vi) mental health, quality of life and positive health; vii) haematology and     biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone     health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an     intention-to-treat basis and per protocol.   "
53710|NCT02582554|"     Good nutrition is necessary for optimal growth and development in young children. Nutrition     risk screening can identify those at risk and to refer them for assessment and treatment. The     NutriSTEP® (Nutrition Risk Screening for Every Preschooler) questionnaires are 17-item,     community-based, parent-administered questionnaires for identifying nutritional risk in     toddlers (18-35 months) and preschoolers (3-5 years). Internet versions are available on the     Dietitians of Canada website as part of a Nutri-eSTEP online tool. NutriSTEP® is mandated for     use in Ontario and New Brunswick and is also used in other provinces. NutriSTEP® has been     implemented in Canadian jurisdictions and in research settings. Many health care     practitioners, mainly registered dietitians, and policy makers, are asking for evidence that     NutriSTEP® makes a difference and this project is proposed to show that nutrition screening     with NutriSTEP® with its accompanying nutrition education resources will increase knowledge     and change nutrition-related practices by parents of preschoolers.      This research will be a randomized control trial with more than 150 parents/caregivers of     toddlers and preschoolers. The treatment group will receive screening with the Nutri-eSTEP     version of NutriSTEP® and will receive the accompanying nutrition education messages and     links to resources. A control group will receive the screening treatment at the end of a 12     week intervention. At the beginning and end of the 12 week period, parents/caregivers will     fill out questionnaires on parental nutrition knowledge and nutrition-related behaviour     (including attitudes and intentions).      This will be the first study of nutrition risk screening with NutriSTEP® to determine if the     screening process, along with its accompanying nutrition education messages makes a     difference.   "
53711|NCT02582541|"     Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct     obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the     duration of stent patency. RFA has showed promising results for malignant bile duct     obstruction and increasing the duration of stent patency. The aim of our study was to     evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct     obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of     self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.   "
53713|NCT02582515|"     Expert reviews and practice parameter papers recommend behavior therapy as a first-line     intervention for youth with chronic tic disorders (CTDs) with mild-to-moderate tic severity.     Although behavior therapies like the Comprehensive Behavioral Intervention for Tics (CBIT)     are efficacious in reducing tic symptom severity, only 50% of individuals exhibit a positive     treatment response. Thus, there is a clear need to identify strategies to improve treatment     response and/or accelerate therapeutic gains .      The primary ingredient of CBIT is habit reversal training (HRT), which utilizes both     extinction and associative learning. Psychosocial treatments relying on these learning     mechanisms have demonstrated an enhanced and/or expedited therapeutic benefit when augmented     with d-cycloserine (DCS). This feasibility study will examine the incremental efficacy of     HRT+DCS over HRT+placebo for tics targeted with HRT. Eligibility criteria will parallel the     child CBIT trial for generalizability and comparability, with the addition of DCS     contraindications as exclusionary criteria. Parents and youth will complete a battery of     clinical assessments to ascertain tic symptoms severity and co-occurring psychiatric     conditions. Afterwards, participants will be randomly assigned to receive either HRT+DCS or     HRT+placebo. Instead of a full course of HRT (8 sessions over 10 weeks), a more efficient     Quick-Win/Fast-Fail trial design will be used that includes a truncated HRT protocol to     provide results in a more timely fashion. As a result of this trial design, the primary     outcome of this study will focus on the reduction of bothersome tic severity for those     targeted in treatment rather than global severity reductions.   "
53714|NCT02582502|"     The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in     improving neurological function in patients who are 6 to 36 months post ischemic stroke.   "
53715|NCT02582489|"     The proposed research study aims to evaluate the effects of autologous bone marrow aspirate     concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients     undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will     compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC     post-meniscectomy and those who receive a saline control injection. The study will also     compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis     is that those who receive the autologous BMAC injection after the procedure will have better     outcomes than those who do not.   "
53716|NCT02582476|"     This is a randomised, double-blind, placebo-controlled phase II clinical trial with a     cross-over design to investigate the efficacy of bumetanide in patients with hypokalemic     periodic paralysis (HypoPP).      The aim is to assess the efficacy of bumetanide in reducing severity and duration of a focal     attack of weakness in a hand muscle.      Twelve participants will be recruited.   "
53717|NCT02582463|"     The purpose of this study is to develop a prediction-tool, the Medicines Optimisation     Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of     preventable medication related problems (MRPs). This has the potential to permit pharmacists     to identify and focus on the small number of patients (approximately 6%) who are likely to     experience a significant MRP while in hospital.   "
53718|NCT02582450|"     Research project for validation of a questionnaire on compliance to treatment in patients     with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the     international methodology validation questionnaires: reverse translation, according to     intersubject patients, psychometric validation and reliability analysis with large sample of     patients.   "
53719|NCT02582437|"     The purpose of this study is to find difference in Minimum Alveolar Concentration(MAC) for     maintaining Bispectral Index (BIS) below 50 between chronic opioid users and opioid naive     patients.   "
53720|NCT02582424|"     This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.   "
53721|NCT02582411|"     Some of the most prevalent eye diseases such as age-related macular degeneration, glaucoma     and diabetic retinopathy are associated with ocular perfusion abnormalities. Currently, there     is no gold-standard method for the measurement of ocular blood flow available. Laser speckle     flowgraphy is a promising technique for the two-dimensional assessment of ocular blood flow     in humans. So far the technique has, however, been only gained widespread use in Japan. The     experience in Caucasian subjects is very limited. In a Japanese population it was shown that     mean blur rate, a measure of chorioretinal blood velocity, decreases with age. This is of     relevance, because an age-related decline in ocular blood flow may partially explain the     age-dependence of ocular vascular disease. The present study investigates this age-dependence     in healthy subjects. In addition, the investigators investigate in a sub-group of this     population whether relative flow volume (RFV), a novel index of blood flow in the human     retina derived from laser speckle flowgraphy is associated with retinal blood flow as     assessed with bi-directional Doppler Optical Coherence Tomography (DOCT).   "
53722|NCT02582398|"     This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the     brain between seasonal affective disorder patients and healthy controls using positron     emission tomography. In addition the investigators aim to demonstrate the impact of light     therapy on MAO-A distribution.   "
53723|NCT02582385|"     The investigators aim at exploring the differential/topographical in-situ expression of     cytokines in the central nervous system (CNS) of patients who died with amyotrophic lateral     sclerosis (ALS), using archived histopathology slides and residual paraffin blocks from     autopsied cases. Previous studies from the investigators and other groups showed that     inflammatory cytokines are implicated in several neurological affections, particularly     neurodegenerative conditions. However, in-situ cytokine expression has never been studied so     far in ALS. The investigators wanted to see if these neuro-mediators are involved in the     neuromolecular chain/cascade underlying ALS.   "
53724|NCT02582372|"     Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and     motor block with prolonged postoperative analgesia without hemodynamic compromise.      OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine     spinal anesthesia for lower abdominal surgeries.      METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I     - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10     mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg     intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2     saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block,     motor, sedation and peripheral neurological manifestations of toxicity.   "
53727|NCT02582333|"     Background:      Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many     patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the     leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral     therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998,     and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high     viral load in a maximum duration of three years. However, there is a significant proportion     of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and     hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current     knowledge, in what conditions that the NA therapy can be successfully discontinued without     hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate     the clinical and virological changes of CHB patients after stopping NA therapy, and finding     the prognostic indicators may be an important basis for stopping NA therapy in CHB patients     in the future.      Objectives:        1. To access the clinical and virological changes after stopping NA therapy        2. To determine important prognostic indicators for stopping NA therapy      Methods:      In this prospective cohort study, the investigators plan to recruit CHB patients who are     indicated for stopping NA therapy in the outpatient clinics according to the inclusion and     exclusion criteria of this study, and clinical and virological data will be collected during     routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed     according the following data:        1. Patient characteristics: including age, sex, height, weight, waist circumference,          history of alcohol drinking, antiviral therapy history, hepatitis history, and drug          history.        2. Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis          flare in the first 2 years after stopping NA therapy, liver function and virological          status tests will be conducted for analysis.   "
53728|NCT02582320|"     This is a retrospective observational study aimed at describing the characteristics and     outcome of CLL patients included in the NPP in Italy in a period of time ranging from the     start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by     collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be     observed for at least 12 months from the treatment start.   "
53729|NCT02582307|"     There is ample evidence that pain in children is under recognized and under treated. This is     especially true for acute abdominal pain, a common complaint in the paediatric emergency     department. Clinicians often fear that analgesia will obscure the diagnosis of a potentially     surgical condition. As a result, acute abdominal pain goes untreated in many children, as     there is no standard of care. Hyoscine N-butylbromide (Buscopan) has been used successfully     in adults and children for pain associated with urinary tract infections and kidney stones     for over 60 years. However, no study has explored its usefulness in relieving acute abdominal     pain in children. The objectives of this study are to investigate to what degree Buscopan is     effective in relieving abdominal pain in children compared to acetaminophen.   "
53730|NCT02582294|"     Fabry's disease is a progressive systemic disease X-linked which combines neurological     (Fabry's pain crises), dermatologic (angiokeratomas), renal (renal failure), cardiovascular     (hypertrophic cardiomyopathy, valvular disease, conduction disorder, coronary heart disease)     and cerebral vascular (stroke) symptoms .      It is a glycosphingolipid metabolism disorder due to deficient or absent activity of the     alpha-galactosidase A, causing accumulation of globotriaosylceramide in the lysosomes.      The incidence is estimated being 1/40 000. Some patients suffering from Fabry's disease today     are of childbearing age and their multidisciplinary care (by neurologists, obstetricians and     anesthetists) raises several questions.      About the anesthetic, the question of epidural block is debated in patients with neurological     diseases and recommendations are not unequivocal.      Indeed one of the problems of the management in those conditions is the potential worsening     of the disease because of the anesthetic procedure. In addition, the possibility of an     antiplatelet and / or an anticoagulant treatment in these patients may also contre-indicate     an epidural block.      The rate of epidural block achieved in patients with Fabry's disease is not currently known.     Moreover, only sparse data on pregnancy outcomes in these patients are reported.   "
53731|NCT02582281|"     The non touch technique is a modification of the traditional intrauterine device insertion     technique. It abolishes the use of Allis and uterine sounding.   "
53732|NCT02582268|"     A previous trial performed by our research team, in order to reduce the pain associated with     intrauterine device insertion, compared the novel technique of IUD insertion under the     guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It     came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain     score and time taken for insertion, when compared with the traditional method. In this study     our researchers aim to abolish the distracting effect of the technician and the TAS probe     (which might have interfered with previous results).   "
53733|NCT02582255|"     A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine     type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.   "
53734|NCT02582242|"     This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of     thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with     type 2 diabetes inadequately controlled with basal insulin.   "
53735|NCT02582229|"     Surgery is the only effective treatment for morbid obesity and can be divided into     restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary     pancreatic deviation and duodenal switch) or a combination of both (RYGBP).      This later technique is the most common and most effective surgical procedure performed     worldwide and has been processed to be an effective treatment of morbid obesity and its     complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery (1,2).      Vertical gastric plication is a novel surgical approach for reducing the stomach capacity.     Anterior surface plication and greater curvature plication are variations of vertical gastric     plication that reduce the gastric capacity through infolding of the anterior surface or     greater curvature of the stomach, respectively. These approaches have been tested, with     positive results (3,4).      A transoral or endoluminal approach (ie, a procedure that requires no incision, because     access is granted through the mouth) offers the potential for additional benefit to the     patient, because the procedures continue to become more and more minimally invasive.      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring     bariatric procedures performed via flexible endoscopy. Although these procedures may not be     as effective as their surgical counterparts, these less-invasive options may relieve patients     of the significant risks associated with surgery (5).   "
71335|NCT02352025|"     The primary objective of this study is to determine if S-equol, an ER-beta agonist, is     effective in decreasing the proliferation rate of triple negative breast cancer.   "
53891|NCT02580201|"     The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe     adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5     year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity     (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in     vaccine-naïve infants.   "
53737|NCT02582203|"     The proposed study is a prospective, open-label, randomized, multi-center trial of     ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk     for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John     Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November     2015 will be evaluated for inclusion. Patients must present with at least 3 of the following     local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge,     induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline     or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study     drug will follow a randomized list that was previously generated via a computerized random     mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients     will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours     for patients with normal renal function. Patients randomized to vancomycin will receive the     standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and     interval adjusted based on creatinine clearance and via institution-specific pharmacy     protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours.     Outcomes measured in the Clinically Evaluable patient population include day two or three     size reduction (percentage) and clinical response at end of therapy or discharge.   "
53738|NCT02582190|"     There is substantial evidence linking inflammation to the initiation and perpetuation of AF.     Although the precise mechanism by which inflammation contributes to the development of AF     remains unclear, it has been proposed that inflammation may lead to atrial myocarditis with     subsequent electrical and structural changes involving both atrial myocytes and extracellular     matrix, leading finally to initiation and maintenance of AF. The high incidence of AF in     post-operative cardiac surgeries, a state of intense inflammatory process, points out this     association. Similarly, in non operative AF, inflammation appears to play a prominent role in     both etiology and maintenance of AF. Indeed an increase of inflammatory markers to both     paroxysmal and persistent AF was shown by numerous studies.   "
53739|NCT02582177|"     To evaluate the superiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64     mg/g association (Candicort®) cream or ointment versus clotrimazole 10mg and dexamethasone     acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms     (erythema, maceration, peeling, blistering / papules / pustules, itching and burning /     stinging) 06 (± 1) days after onset treatment.   "
53740|NCT02582164|"     Young children age 6 month to 6 years are often not able to cooperate for advanced OCT eye     imaging. The purpose of this study is to investigate the use of a novel long-working distance     swept source (SS) optical coherence tomography imaging system with fixation alignment for use     first in young adults, older children, and then young children ages 6 months to 6 years. The     investigator's future goal is to obtain important retinal and optic nerve information from     OCT in clinic in these young children.   "
53741|NCT02582151|"     Neurogenic bladder patients may have symptoms of urinary frequency, urgency, urgency     incontinence and voiding symptoms due to bladder dysfunction arising from their underlying     neurologic condition. Current treatment options are effective for some patients, however many     patients are not optimally managed due to modest efficacy or significant side effects. Second     line therapies include intravesical onabotulinum toxin, however it is associated with a risk     of urinary retention, and patients with neurologic disorders often are unable to perform self     catheterize due to physical limitations. Sacral neuromodulation is associated with an     undesirably high cost and potential complications in this population. The use of     transcutaneous tibial nerve stimulation is an alternative form of neuromodulation, and it may     have some potential benefits over percutaneous tibial nerve stimulation. While some     preliminary studies have suggested it may be effective, there are no high quality randomized     trials. This proposal is a 3 month, randomized, sham-controlled, clinical trial to evaluate     the short term clinical efficacy of at home transcutaneous tibial nerve stimulation. Valid     and reliable patient reported outcome measures, and objective measures of incontinence have     been included as outcomes.   "
53742|NCT02582138|"     The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme     (physical activity, nutritional counselling/dietary intervention, and information and     communications technology intervention) compared with a healthy aging lifestyle education     programme on mobility disability, in non-disabled older people with physical frailty and     sarcopenia.   "
53743|NCT02582125|"     The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects     with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy     and resistant to a platinum-based chemotherapeutic regimen.   "
53744|NCT02582112|"     This prospective, double-blinded, randomized, controlled study was undertaken to evaluate     whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine     and transfusion requirement and lower fluid consumption than use of room-temperature fluids     (22 oC) in cesarean delivery patients undergoing spinal anesthesia.   "
53745|NCT02582099|"     Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve     symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj     hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have     been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.   "
53746|NCT02582086|"     The aim of this study is to determine the safety and efficacy of a topical natural health     product in comparison to placebo for the treatment of herpes labialis.   "
53774|NCT02581722|"     A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically     shift the MC landscape. PrePex is an innovative circumcision device requiring no injected     anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally     skilled healthcare professionals rather than surgeons. Two initial studies conducted in     Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was     performed by skilled physicians   "
53789|NCT02581527|"     In this trial, the investigators are assessing whether giving an increased dose of rifampicin     to patients receiving the standard treatment for tuberculosis is safe and, when given for 4     months only, will also result in greater and faster killing of the tubercle bacillus in the     lungs and result in relapse rates similar to those found in the World Health Organisation     (WHO) recommended standard 6 month regimen.   "
53747|NCT02582073|"     There is increasing evidence that the effectiveness of allergy immunotherapy to control     symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid     administered during a single regimen of subcutaneous (SC) injections or of sublingual     administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four     injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly     intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU     and 18200 SU are being developed to compare with the current dose. The study is designed to     explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL     immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA     (without MPL) and placebo.   "
53748|NCT02582060|"     Currently dosing for prophylaxis is not individualized, and the general approach is to use a     dose of 25-40 units/kg given 3 times per week or every other day. One of the issues with     weight-based dosing is the possible over-treatment. This is likely due to the fact that     laboratory tests are not sensitive enough at the low levels to support decision-making. The     Thromboelastograph (TEG®) and Thromboelastometry (ROTEM®) are coagulation devices, which     assess the dynamics of clot formation over time and have several characteristics which     suggest they may provide important information for individualized prophylaxis treatment for     our patients.   "
53749|NCT02582047|"     Previous studies have demonstrated the immunogenicity and safety of the co-administration of     the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal     vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison     study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or     PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of     concomitant administration in the elderly subjects.   "
53750|NCT02582034|"     The purpose of this study is to determine whether a treatment with Therasphere which is     optimized is more efficient compared to a standard treatment for patients suffering from     hepatocellular carcinomas.   "
53751|NCT02582021|"     The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made     many contributions to the understanding of cardiovascular disease. A milestone acknowledged     in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in     women with symptoms/signs of ischemia without obstructive coronary artery disease (CAD).     While in 1996, CMD was considered an imaging artifact, in 2013, it is a widely accepted as     a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is     prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare     costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new     cases projected annually placing CMD prevalence, morbidity and costs higher than all female     reproductive cancers combined.      Among women with ischemia, preserved ejection fraction and no obstructive CAD, it has been     observed that there are relatively more new onset heart failure (HF) hospitalizations than     nonfatal myocardial infarction (MI). It has been hypothesized that CMD contributes to left     ventricular (LV) diastolic dysfunction and subsequent heart failure with preserved ejection     fraction (HFpEF). Preliminary data further suggests that left ventricular diastolic     dysfunction is linked to CMD via a mechanism of augmentation and/or perpetuation by     cardiomyocyte fat accumulation. HFpEF is prevalent in women and older men, but poorly     understood. Mechanistic understanding is critical to HFpEF intervention and guideline     development.      The study hypotheses are as follows:        1. Risk factor conditions (hypertension, dyslipidemia, dysglycemia, loss of estrogen)          promote an inflammatory and pro-oxidative state making the microvasculature vulnerable;        2. Vulnerable coronary microvasculature becomes dysregulated (sympathetic nervous system          activation, endothelial dysfunction, changes in vascular smooth muscle activation,          spasm) causing repeated episodes of transient ischemia;        3. Repeated ischemia-reperfusion episodes facilitate preconditioning with preservation of          cardiomyocyte contractile and microvascular function against ischemic injury;        4. Ischemia-reperfusion and preconditioning lead to cardiomyocyte fat accumulation and          relaxation impairment resulting in diastolic dysfunction and heart failure with          preserved ejection fraction (HFpEF).   "
53752|NCT02582008|"     This pilot randomized clinical trial studies how well bupropion hydrochloride works compared     with patient's choice for quitting smoking in patients with squamous cell head and neck     cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may     help patients quit smoking by enhancing central nervous system neurotransmitters     noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride     is more effective than patient's choice in helping quit smoking in patients with squamous     cell head and neck cancer undergoing radiation therapy with or without chemotherapy.   "
53753|NCT02581995|"     To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first     year of treatment with aflibercept according to the EU Label.   "
53754|NCT02581982|"     This phase II trial studies how well paclitaxel and pembrolizumab works in treating patients     with urothelial cancer that has not responded to previous treatment and has spread to other     places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may     interfere with the ability of tumor cells to grow and spread. Giving paclitaxel together with     pembrolizumab may be an effective treatment for urothelial cancer.   "
53755|NCT02581969|"     Following the performance of the POTTER observational study, whose primary objective was to     collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of     prevention of bleeding episodes, the present study aims to extend the observation time up to     10 years, of the same population involved in the previous study.      The present study has been designed to allow a focus on long term disease-related damage at     joint level in subjects with severe haemophilia A, as well as on the pharmacoeconomics impact     of the two different treatment regimens.   "
53770|NCT02581774|"     The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies     complicated with isolated oligohydramnios managed by induction of labor. This prospective     case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital     between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women     with postdate pregnancies who met the inclusion criteria underwent induction of labor with     dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared     between two groups.   "
53771|NCT02581761|"     A randomized prospective double blind study of misoprostol administration in asymptomatic     patients with pregnancies of unknown location.   "
53772|NCT02581748|"     Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group     Phase I study to compare PK profiles and to assess the safety and immunogenicity between     HLX02 and Herceptin® (U.S. and German).   "
53773|NCT02581735|"     Research project whose main objective is to evaluate the use of a technology platform     (uPatient) to register the prophylactic treatment of patients with hemophilia treated in     different Hematology and Hemotherapy services of several hospitals in Spain.   "
53756|NCT02581956|"     Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is     increasing probably due to the prolonged life expectancy and a variety of environmental     factors. Fortunately, breast cancer outcome and survival are improving due to early detection     and new treatment modalities. After making first strides against breast cancer, i.e.     undergoing ablation surgery, most breast cancer survivors still have to go through a series     of chemotherapy, which could prolong their survival but almost inevitably downgrade their     quality of life due to grueling side effects, such as lack of energy and vulnerability to     infection. Numerous medical interventions have been tried by healthcare providers to     alleviate these side effects, but some of them are expensive and therefore become another     burden for the cancer-afflicted patients. Previous studies have already indicated that     exercise generated long-term benefits to breast cancer survivors, including improved physical     functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both     immune function and quality of life. Among a variety of exercises, walking is the least     costly, easy-to-follow type. Through a simple, predesigned walking regimen, the investigators     expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap     some benefit either physically or psychologically.      Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a     useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as T     helper cells, play an assistant role in the immunologic process, such as maturation of B     cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+) T     cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and tumor     cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a     reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a     widely adopted tool to evaluate patient's individual health status. By means of serial blood     sample collections and the delivery of SF-36 survey, this study aimed to objectively and     quantitatively evaluate the effects of aerobic walking on the breast cancer patients     undergoing chemotherapy.   "
53757|NCT02581943|"     This randomized pilot phase II trial studies the effect of pembrolizumab with or without     carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer     that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving pembrolizumab together with carboplatin and paclitaxel may improve immune     responses in patients with non-small cell lung cancer.   "
53758|NCT02581930|"     This phase II trial studies how well ibrutinib works in treating patients with stage IV     melanoma of the skin that has not responded to previous treatment. Ibrutinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
53759|NCT02581917|"     This research trial studies metabolic changes in blood samples from patients with acute     myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the     laboratory may help doctors learn more about cancer and the development of drug resistance.   "
53760|NCT02581904|"     The purpose of this study is to determine if the application of a negative pressure dressing     intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound     complication rate in high risk patients.   "
53761|NCT02581891|"     This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend     regimen with aflibercept in subjects with nAMD.   "
53763|NCT02581865|"     Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of     NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will     enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.   "
53764|NCT02581852|"     This study compares workability in subjects with seropositive rheumatoid arthritis (RA) in     the working age with high and low disease activity. Further interest is to clarify the     influence of frailty, functional ability and muscle strength on workability and to determine     the effect of disease activity on selected physiological needs (sleep quality, sexual     functioning). Methods include a physical examination, questionnaires and physical tests.   "
53765|NCT02581839|"     Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug.     Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by     the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is     FDA approved for use in patients with metastatic breast cancer but the effect it may or may     not have on brain metastases has not been studied.   "
53766|NCT02581826|"     The objectives of the present study aims to evaluate the safety and efficacy of Silodosin in     a population of patients wih Premature Ejaculation (PE). Coupled with efficient diagnosis, it     is hoped that the newer agent will improve the quality of life for patients who suffer from     Premature Ejaculation (PE).   "
53767|NCT02581813|"     The purpose of this study is to examine whether increased dairy intake, at the level     recommended by Canada's Food Guide, combined with healthy eating and exercise, will improve     body composition and bone turnover over 12 weeks in overweight and obese girls.   "
53768|NCT02581800|"     Background: Premature infants and their patents are discharged earlier from hospital and sent     home in early in-homecare programs. Research regarding the use of health IT is needed to say,     whether the use of videoconference and Smartphone application is a viable option to address     the parents need for support in relations to early discharge.      Aim: Test and explore early in-homecare (PreHomeCare) with videoconference and mobile     application versus hospital consultations.      Method: Main study; a randomized controlled intervention study with the hypothesis; parent of     premature infants who have access to electronic knowledge and participatory guidance 24-7:     increases proportion of exclusive breastfeeding, Improves parent/infant interaction, enhances     confidence and increases knowledge.      Sub study 1; a field study. Sub study 2; an interview study. Perspectives: It is expected     that this project will be an argument in development of care for premature infants and     telemedicine use in the future   "
53769|NCT02581787|"     The SABR-ATAC trial (Stereotactic Ablative Radiotherapy and anti-TGFB Antibody Combination)     is a phase I/II trial that studies the side effects and efficacy of fresolimumab, an     anti-transforming growth factor beta (TGFB) antibody, when given with stereotactic ablative     radiotherapy in patients with stage IA-IB non-small cell lung cancer. Fresolimumab may     inhibit radiation side effects and block tumor growth through multiple mechanisms.     Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiotherapy     (SBRT), is a specialized form of radiation therapy that precisely delivers high dose     radiation directly to tumors, thus killing tumor cells and minimizing damage to normal     tissue. Giving fresolimumab with SABR may work better in treating patients with early stage     non-small cell lung cancer than treating with SABR alone.   "
54449|NCT02572908|"     This is randomized pilot study comparing tolerability of yeast-baked wheat bread and     sourdough wheat bread in irritable bowel syndrome.   "
53777|NCT02581683|"     Proper analgesia after total knee arthroplasty (TKA) is important for encouraging early     ambulation, which can facilitate improved patient outcomes and early hospital discharge. For     pain control after TKA, adductor canal blocks (ACBs) improve upon the gold standard femoral     nerve blocks (FNBs) since they do not cause as much quadriceps muscle weakening, while     providing equivalent analgesia. Multimodal analgesia has become commonplace as a method of     superior pain control with fewer side effects. Magnesium sulfate as an adjuvant to FNB local     anesthetics can improve pain control after surgery; however, it also prolongs time to     ambulation. There are no reports on the effect of magnesium sulfate in ACBs on analgesia     after TKA. Thus the purpose of this randomized, double-blind, controlled trial is to     determine whether magnesium sulfate given with local anesthetics via ACB can prolong     analgesia, reduce pain scores and opioid consumption, and increase mobilization in TKA     patients.   "
53778|NCT02581670|"     Investigators designed a phase II study to evaluate safety and efficacy of lung and liver     stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for     surgery, using VMAT RapidArc approach.   "
53779|NCT02581657|"     This study is a randomized, double-blind (Investigator and study subject), placebo controlled     multiple dose sequential ascending dose study that will enroll up to 47 male and female     subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts.   "
53780|NCT02581644|"     The purpose of the study is to determine a) if the implementation of belatacept patient alert     card (PAC) resulted in effective understanding of key safety messages and b) if the degree of     understanding of key safety messages is associated with improved clinical and safety     outcomes.   "
53781|NCT02581631|"     The purpose of this study is to determine whether Nivolumab, in combination with brentuximab     vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas     with CD30 expression that have not responded to treatment or have come back. The subtypes we     are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL),     Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and     Mediastinal Gray Zone Lymphoma (MGZL).   "
53782|NCT02581618|"     Myocardial injury occurs after percutaneous coronary intervention due to micro emboli,     ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning     has been shown to be useful in preventing myocardial injury but it is not suitable to perform     it especially in ad hoc interventions. In this study the investigators aim is to show whether     one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during     percutaneous coronary intervention.   "
53783|NCT02581605|"     For participants whose leg bones don't line up properly, extra stress is placed on either the     inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually, this     extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that side of     the knee joint. This problem is particularly common in young athletes and places them at risk     of early osteoarthritis.      An operation exists whereby one of the bones either side of the knee is cut ( an osteotomy)     and hinged open to straighten the leg. This alteration redistributes body-weight more equally     across the knee joint and is known to be effective in delaying and possibly preventing, the     progression of knee osteoarthritis- especially in younger and physically more active patients     in whom a knee replacement is undesirable.      Currently it is possible to ( accurately) calculate the precise position of the bone cut and     number of degrees correction required to straighten a leg using digital x-rays and     three-dimensional CT scans. However there is no method of implementing this pre-operative     plan during surgery so that the majority of surgeons rely on relatively crude and ipso facto     unreliable intra-operative measurements as a guide.      To improve the accuracy of this operation, the investigator propose the use of a custom-made     'cutting block', tailored for each individual patient and its shape will match the contour of     the patient's bone to ensure it can only be placed in one position. Pre-cut slots and holes     will then guide the saw cut and the number of degrees the bone in hinged open, as per the     pre-operative plan; it functions as an intra-operative template for the surgeon.      This study will primarily examine whether there is a close match between the planned and     actual correction of leg deformities when using a patient-matched cutting-block.   "
53784|NCT02581592|"     This multiple-center, nonrandomized, open label, parallel group, single dose study will be     conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh     Class B) hepatic impairment to evaluate the effect of hepatic impairment on the     pharmacokinetics (PK) of TD-4208.   "
53785|NCT02581579|"     This is a doble-blind, masked, compared with placebo clinical trial in pediatric population     in contact with tuberculosis with or without tuberculosis infection. This trial aims to study     the effect of the probiotic Nyaditum resae® at the level of specific Treg memory cells eight     weeks after the first administration, and the global tolerability of the treatment.      Nyaditum resae® is a preparation in the form of capsules containing heat-killed environmental     mycobacteria Mycobacterium manresensis. The overall objective of the study is the effect of     Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis.   "
53786|NCT02581566|"     Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on     postoperative pain after knee arthroscopy.   "
53787|NCT02581553|"     This study will assess relative bioavailability of lesinurad/allopurinol fixed dose     combination (FDC), its individual components and the effect of food.   "
53788|NCT02581540|"     The aim of this observational study is twofold. The primary hypothesis being tested is that     initial(first) high sensitivity Tn <5ng/l (limit of detection) combined with an ECG with no     ischaemic changes is superior as an accelerated diagnostic tool/strategy compared to TIMI     score (<2), GRACE <75 and HEART score ≤ 3. (Hs tn T- Roche elecsys HS tn T) and also against     HS troponin at the 99th percentile (<15ng/l with nonischaemic changes)- again all scored with     initial (first tn ) only.      The second aim is to directly compare the three established methods of risk stratifying     patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute     Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the     era of high sensitivity troponins performs best.   "
55673|NCT02556918|"     The purpose of this study is to determine whether treatment with sitagliptin reduces the     frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to     determine whether treatment with sitagliptin is effective in maintaining blood sugar control     in patients with type 2 diabetes (T2D).   "
53790|NCT02581514|"     Eosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is     frequently encountered in internal medicine.      Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and     solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can     be life-threatening Eosinophilia can be a diagnostic dilemma, as the etiologies are extensive     and varied.      The aim of this study is to assess the feasibility of a diagnostic approach based on a     decision algorithm in a group of patients with eosinophilia.      We assume that a procedure with a hierarchy of additional tests would increase the frequency     of diagnosed cases while decreasing the time to diagnosis.      This procedure defined by an algorithm would even reduce the number of tests necessary to     reach a diagnosis.   "
53791|NCT02581501|"     GAX represents a novel approach to the development of cancer chemotherapy agents in     pancreatic cancer and is based upon extensive laboratory investigations for the induction of     apoptosis in pancreatic carcinoma cells.   "
53792|NCT02581488|"     This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers     with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid     decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing     silver. After meeting study criteria, participants will be randomly assigned to apply Santyl     or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end     of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of     the study treatment.   "
53793|NCT02581475|"     Segmental examination twice of the proximal colon might be helpful to increase adenoma     detection rate (ADR).   "
53794|NCT02581462|"     Previous studies provide a strong theoretical rationale for the conduct of a randomized study     evaluating the efficacy and safety of Herceptin and pertuzumab in combination with FLOT in     the perioperative treatment of resectable HER-2 positive adenocarcinoma of the stomach or     GEJ.   "
53795|NCT02581449|"     The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on     pediatric patients undergoing hemodialysis via the measurement of the following before and     after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.   "
53796|NCT02581436|"     This study evaluates the addition of Kidney Solid Organ Rejection Test (kSORT), in the     clinical follow-up of renal transplant recipients, compared to clinical standard surveillance     in the first two years after kidney transplantation. The design of the study is a partially     blinded, randomized control trial of patients with living and deceased donor. The recruitment     will be in a third level attention hospital in Mexico city (Instituto Nacional de Ciencias     Médicas y Nutrición Salvador Zubirán). The main outcomes are the rate and grade of acute     rejection, histologic chronic index of the one year protocol biopsy and glomerular filtration     rate.   "
53797|NCT02581423|"     This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants     who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in     3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24     weeks, and the target sample size is 70 individuals.   "
53798|NCT02581410|"     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5     years earlier.   "
53799|NCT02581397|"     This study evaluates the non-inferiority of Suppository Transpulmin and Suppository Guaiacol     compared to Transpulmin Syrup in the treatment of cough with secretion of infectious origin     in children between two and six years old. One third of participants will receive Suppository     Transpulmin, the other one third will receive Suppository Guaiacol and the last one third     will receive Transpulmin Syrup.   "
53800|NCT02581384|"     This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment     for lung relapse of Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumor. SBRT is a form of     targeted radiotherapy that can treat very small tumors using a few large doses.   "
53801|NCT02581371|"     The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin     in combination with standard therapy on the dynamics of recovery of the paretic upper limb in     patients with acute ischemic stroke.      Each patient participates in the study for 176-190 days (approximately 6 months). The     estimated duration of the study is 2 years.   "
53802|NCT02581358|"     The purpose of the study is to investigate the validity of Scolioscan for quantitative     assessment of curve severity in scoliosis using x-ray radiographs as the gold standard.   "
53803|NCT02581345|"     The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed     adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic     plaque-type psoriasis.   "
53823|NCT02581085|"     The purpose of this Phase IIA trial is to validate the outcome observed in the Phase I trial     that oral TCT attenuates the rise in MELD over time in patients diagnosed with NAFLD, NASH or     chronically infected hepatitis C. Subjects will participate for 3 years. They will be asked     to come to 8 total study visits and will receive 6 follow-up phone calls within the 3 years     of participation. Subjects will be asked to take 2 study capsules of vitamin E Tocotrienol     (200mg) twice a day or 2 placebo capsules twice a day. The study is randomized and study     staff will be blinded to randomization.   "
53824|NCT02581072|"     The study is a 4 way cross-over study in subjects with moderate to severe acne vulgaris who     will each receive SB204 4%, a supratherapeutic dose of SB204 (either 8 or 12%),     moxifloxacillin (positive control) and appropriate placebo to match. SB204 will be applied     topically to the upper back, upper chest, upper shoulders, and face.   "
53825|NCT02581059|"     This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients     treated with regorafenib to determine if ginseng will reduce fatigue in this patient     population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and     randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng     group and 30 enrolled in the regorafenib + no ginseng group.   "
53892|NCT02580188|"     This study is a randomized, controlled, double-blinded, and parallel design study. A total 96     patients were randomized to receive a deep block or a moderate block scheduled for elective     laparoscopic colorectal surgery. Investigators estimated the proportion of intra-abdominal     pressure(IAP) alarm and surgical rating score.   "
53804|NCT02581332|"     The purpose of this study is to examine the effects of a brief mindfulness meditation     intervention on clinical and experimental pain in fibromyalgia (FM) patients as compared to a     wait-list control condition. Based on prior research, investigators' working hypothesis is     that this intervention will decrease the severity of FM-associated clinical pain and     experimentally induced pain in comparison to pre-intervention scores and a wait-list control     group. Additionally, based on prior work, investigators postulate that mindfulness meditation     training will decrease a) depression, b) state anxiety, c) overall disease severity, and d)     perceived stress, while increasing e) quality of sleep, and f) mindfulness skills in     comparison to pre-intervention scores and the wait-list control group.      Investigators will also be testing if decreases in pain ratings during meditation correspond     to increases in parasympathetic activity. The relative systemic contributions of the     parasympathetic and sympathetic branches of the Autonomic Nervous System (ANS) can be     examined by measuring heart rate variability (HRV), or the variability in the beat-to-beat     interval. Fast acting, parasympathetically-mediated high frequency (HF) changes in heart rate     variability (HF HRV; 0.15-0.40 Hz) provide a reliable indicator of parasympathetic activity.     Importantly, decreased HF HRV correlates with increased pain. Investigators therefore will     employ psychophysical and physiological methodologies to test the hypothesis that the     analgesic effects of mindfulness meditation in FM patients are associated with increases in     HF HRV.   "
53805|NCT02581319|"     Smoking has been considered the most important risk factor for periodontitis among all     lifestyle factors. Fewer studies evaluated longitudinal clinical and microbiological status     of smokers undergoing periodontal maintenance therapy and controversial results were found.     This study will evaluate clinical conditions and prevalence of putative periodontopathogens     and Candida spp. in smokers and non-smokers at baseline and after 3 and 6 months of     nonsurgical periodontal therapy. Clinical parameters, including oral status assessed using     Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession     (GR), Clinical Attachment Level (CAL) will be measured in smokers and non-smokers patients     with chronic periodontitis. Samples of subgingival biofilm will be obtained from the     periodontal pockets and furcation sites and submitted to phenol-chloroform DNA extraction and     Polymerase Chain Reaction (PCR) analysis using specific primers for Aggregatibacter     actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia,     Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida     dublinienses.   "
53806|NCT02581306|"     If eligible to participate in the research study after completing the physical screening     procedures, participants will be asked to return to the Substrate Metabolism Laboratory on     another occasion after a short fast (no food or beverages - besides water) for at least 6     hours. After participants arrive, participants will rest quietly for approximately 30 min.     The investigators will then collect a blood sample from a vein in participants hand, or     forearm. After obtaining a baseline blood sample, participants will exercise at a moderate     intensity (on a treadmill or a stationary bike) for one hour. This one hour moderate exercise     session will feel like a slow jog during which participants would be able to carry a     conversation. In order for the investigators to measure energy expended and the amount of fat     participants are burning during exercise, the investigators will periodically ask     participants to breathe through a mouthpiece so the investigators can collect participants     expired breath. After the exercise session the investigators will collect another blood     sample from a vein in participants hand, or forearm.   "
53807|NCT02581293|"     In this study the investigators want to asses the effect of peritonisation at c-section on     postoperative vital signs which was thought to be an indirect finding secondary to increased     sympathetic activity originated from pain caused by stretched peritoneum.   "
53808|NCT02581280|"     Extracorporeal membrane oxygenation (ECMO) is the device which increases the supply of oxygen     to the body tissues in vitro and to assist in heart and lung function. Venoarterial (VA) ECMO     is used in patients with cardiogenic shock, cardiac arrest, ventricular arrhythmia and is     able to secure a time to self-recovery by reducing the excessive stimulation applied to the     heart. However, in ECMO patients, pharmacokinetics of drugs are changing such as increased     volume of distribution (Vd) or decreased clearance (CL). For this reason, it is hard to     provide the best treatment in ECMO patients. The study is to evaluate whether the PK of drugs     is influenced by VA ECMO and to recommend the optimal dosing strategies for proposed drugs in     adult patients receiving VA ECMO.   "
53809|NCT02581267|"     Psychiatric presentations are common in the emergency department (ED), and determining     whether or not a psychiatric presentation is due to medical illness can be a difficult task     for the emergency physician. The investigators define serious medical illness (SMI) as a     pathological condition that would necessitate inpatient treatment on a medical or surgical     ward. It is important for patient safety that SMI be triaged by the emergency physician to     the appropriate inpatient service. The rate of missed SMI in patients with psychiatric     presentations to the ED is unknown. The investigators will research missed SMI in patients     referred to adult psychiatry from the ED, with the intent to improve patient safety.   "
53810|NCT02581254|"     Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective     technique for removal of diminutive polyps. Both thick and thin wire snares are now commonly     used for CSP. However, because of their physical characteristics, thick wire snares might     leave a higher percentage of residual adenoma at the resection site. Since this may result in     a higher risk of recurrence, the technique needs to be optimized. Experts have suggested that     a thin wire snare might be more efficient, with a lower risk of residual adenoma at the     resection site and consequently a lower risk of recurrence and interval cancer.   "
53826|NCT02581046|"     Congenital cataract is an important treatable cause of visual handicap in childhood     throughout the world. Successful management of childhood cataract is dependent on     individualized treatment strategies and rigorous postoperative supervision for adverse     complication. In this trial, we aimed to compare the difference of postoperative outcome     between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will     be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 month, 6     month, 9 month, 12 month, 18month and 24month postoperatively.   "
55911|NCT02553785|"     This study is a multi-center, prospective, single-armed, study designed to evaluate the     safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left ventricular     (LV) volume reduction in heart failure (HF).   "
53811|NCT02581241|"     The drug-induced long QT syndrome (diLQTS) describes a clinical entity in which     administration of a drug produces marked prolongation of the QT interval of the     electrocardiogram, associated with the development of a polymorphic ventricular tachycardia,     termed torsades de pointes (TdP). The heart rate is an important variable affecting the QT     interval. The QT interval normally shortens as the heart rate accelerates; however, the     adaptation of the QT interval to sudden heart rate acceleration is not instantaneous.     Interestingly, Holter studies show that the speed of response of the QT interval to sudden     changes in heart rate (that is, the time it takes the QT interval of a given person to reach     a new steady-state QT/RR relation) in healthy persons is highly individual and independent of     the basic QTc. The investigators and others recently proposed the quick standing test as a     simple bedside test that facilitates the diagnosis of congenital LQTS. The test takes     advantage of the fact that as one stands up, the heart rate acceleration is abrupt while the     associated QT-interval shortening is gradual. As the R-R interval shortens faster than the QT     interval, the QT appears to stretch toward the next P wave and the corrected QT interval     (QTc) for heart rate actually increases momentarily. The phenomenon of QT stretching is     universal but is exaggerated in patients with LQTS, allowing for a simple but accurate     diagnostic test. There is no data on the effects of quick standing on drug-associated form of     the long QT syndrome. The investigators therefore propose the present study to better     understand who these patients with drug-associated form of the long QT syndrome are and what     the significance of their abnormal QT-response is.   "
53812|NCT02581228|"     This is a retrospective, open label study to establish and validate a prediction technology     for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the     immunotherapeutic drugs Ipilimumab, Pembrolizumab & Nivolumab, in order to predict response     rate and disease progression   "
53813|NCT02581215|"     This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the     efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm     B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both     arms will continue treatment until disease progression or unacceptable toxicity.   "
53814|NCT02581202|"     This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir     (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1)     infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at     least 6 months) at the 48 week time point of treatment in the routine clinical settings of     the Russian Federation.   "
53815|NCT02581189|"     This study seeks to provide evidence of the effectiveness and obtain patient reported outcome     (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic     hepatitis C (CHC) in a real life setting across clinical practice patient populations in     Canada.   "
53816|NCT02581176|"     This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in     patients with cancer. The current standard treatment of venous thrombosis in cancer patients     is subcutaneous injections with low molecular weight heparin. During the last 5 years several     new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis.     But very few cancer patients were included in the phase III clinical trials of the direct     acting oral anticoagulants. Thus, there is a lack of information on how cancer patients with     venous thrombosis will respond to treatment with direct acting oral anticoagulants. The     current study will investigate the direct acting oral anticoagulant apixaban in cancer     patients with venous thrombosis.   "
53817|NCT02581163|"     This study is to provide evidence of the effectiveness as well as the influence of adherence     on treatment outcome of Paritaprevir/ritonavir, Ombitasvir, +/- Dasabuvir, (the ABBVIE     REGIMEN) ± Ribavirin (RBV) in a real world setting of hepatitis C virus infected clinical     practice populations across Belgium. The study may also help identify predictive factors of     response that are important in real world treatment settings. In addition, it will provide     data on the impact of adherence on treatment outcomes in everyday settings, which may help     treating physicians to improve the management of participants under their care.   "
53818|NCT02581150|"     The purpose of this study is to assess the efficiency of outpatient surgery compared to     conventional hospitalization in endovascular treatment of occlusive arterial disease. A     cost-utility analysis will be conducted from a societal perspective. Patients referred for     peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up     will be performed.   "
53819|NCT02581137|"     This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer     in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral     premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub     off and can be associated with a higher risk of cancer. Metformin hydrochloride may help     prevent oral cancer from forming in patients with an oral premalignant lesion.   "
53820|NCT02581124|"     Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP)     inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and     tolerability of JTZ-951 when administered alone and one hour after the administration of     lapatinib.   "
53821|NCT02581111|"     Brain-dead patients who provide authorization for organ donation will be randomized to     naloxone or placebo if baseline arterial blood gas (ABG, after initiation of OPO management)     reveals hypoxemia (PF ratio < 300), unless they have already been ruled-out for lung     recovery. Investigators aim to assess whether naloxone improves oxygenation prior to organ     recovery more than placebo.   "
53822|NCT02581098|"     This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to     wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21     mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT     sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in     the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support     wound healing and will be in the study for 14 weeks that includes 4 study visits.   "
53866|NCT02580526|"     This study compares the effectiveness of two kinds of two-handed facemask ventilation     techniques (when breathing is supported with machines) at the time that general anesthesia is     started. Study participants will start with one technique and then cross over to the other     technique.   "
53827|NCT02581033|"     Evaluation of the rate of sustained virological response among HBeAg-negativechronic     hepatitis B patients who discontinue long-term NA therapy.      During this study participants will cease their prescribed medications, this will occur with     immediate effect once enrolled into the study. The duration of cessation will be indefinite,     unless clinically indicated for NA therapy re-start. Participants will be monitored as per     protocol following cessation, monitoring will be by clinic visit and through blood test to     monitor virological response. Clinical visits will be at the intervals of week 2, week, 4,     week 8, week 12, week 18, following this they will be every 3 months out to 2 years when the     participant will have completed the trial. Once the participant has completed the trial they     will not commence again, the aim is for an indefinite cessation of NA therapy.   "
53828|NCT02581020|"     This study seeks to assess the durability of response and persistence of resistance to     ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3     clinical study with these agents for the treatment of chronic hepatitis C.   "
53829|NCT02581007|"     This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from     partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The     primary objective of the study is to estimate the incidence of graft rejection and acute     GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS,     chronic GVHD and EFS.   "
53830|NCT02580994|"     This is a multicenter, open-label, two armed, controlled, and randomized phase II trial     investigating the activity of pembrolizumab (MK-3475) in combination with standard     chemotherapy in Extensive Disease (ED)-SCLC.   "
53831|NCT02580981|"     Previous work performed by University of New Mexico Comprehensive Cancer Center (UNMCCC)     investigators has revealed previously unknown genomic mutations in children, adolescents, and     young adults with high-risk B and T cell precursor acute lymphoblastic leukemia (ALL). Using     genomic and next generation DNA sequencing technologies, these investigators revealed that     14% of children with high-risk ALL have Philadelphia chromosome-like (Ph-like) ALL.     Patients with this form of ALL were found to have a significantly increased risk of treatment     failure and death.      Further work revealed that there are more than 40 distinct gene rearrangements and fusions     that can result in Ph-like ALL. Cell lines and human leukemic cells expressing some of these     different gene fusions were sensitive to currently available drugs. This suggests that     Ph-like ALL patients with these specific distinct gene fusions should be targeted in future     clinical trials to be treated with appropriate therapy. Further work is also needed to     identify other potentially targetable genetic alterations in ALL patients.      Therefore, the goal of this study is to perform genomic screening of all newly diagnosed ALL     patients seen at UNM and to use this information to enroll patients onto available National     Clinical Trial Network (NCTN) clinical trials. If an appropriate NCTN trial is not available,     best clinical management will be pursued.   "
53832|NCT02580968|"     A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture     formula, and to analysis the regulation of the intensity-effects and to observe the     peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture     treatment.   "
53833|NCT02580955|"     A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon     dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm.      Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW     Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the treatment of long femoropopliteal     lesions (TASC C&D).   "
53834|NCT02580942|"     The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases     in Summer is effective in the treatment of chronic asthma.   "
53835|NCT02580929|"     This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk     relapse hepatocellular cancer patients.   "
53836|NCT02580916|"     Background:      Patient-reported outcome measures (PROMs) provide validated evidence of health and quality of     life (QoL) from the patient perspective. Several national PROMs programmes have been     implemented in the National Health Service - specifically for common elective procedures.     Local implementation is varied across settings and populations. The incidence of non-melanoma     skin cancer (NMSC) is rapidly increasing, posing considerable burden on UK healthcare     resources, yet there is limited evidence of use of PROMs in NMSC and little information about     patients' perceived health and QoL.      Objectives:      This study will explore feasibility of implementing a skin cancer-specific PROM - Skin Cancer     Quality of Life Impact Tool (SCQOLIT) for NMSC.      Methods:      Three hundred patients with a pathological diagnosis of NMSC undergoing all treatment     modalities will be recruited to complete SCQOLIT questionnaires at baseline, at 3, 6 and 9     months. Participation and response rates, missing data and individual change scores will be     analysed. Staff and patients will be interviewed to explore acceptability and feasibility of     collecting PROMs data.      Results:      Interim results of the project to date will be presented. Feasibility will be assessed by     evaluating number of eligible patients, number of consenting patients, reasons for not     consenting and participant number. Individual longitudinal change in scores, response rates     and psychometric properties of the SCQOLIT will be reported.      Implications:      Acceptability and feasibility of the SCQOLIT tool has never been rigorously assessed in     Dermatology clinics. A validated NMSC-specific PROM would help standardize multi-centred     trials, allow robust evaluation of quality of care and more appropriately direct healthcare     resources to improve QoL in patients with NMSC.   "
53837|NCT02580903|"     This is an observational prospective study aiming to clarify the prevalence of pulmonary     hypertension in patients with Myeloproliferative Neoplasms and their prognosis.      All patients attending our department with the above mentioned neoplasms will be offered     inclusion in this study. All will have an echo performed and patients identified as being at     risk of pulmonary hypertension will be offered complete investigation as specified by the     European Cardiology Association.      All patients will be followed up for a total of five years to identify prognosis.   "
53867|NCT02580513|"     This study will evaluate the effect of circadian misalignment on insulin sensitivity in     healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the     research facility for two study periods of 3 and 3.5 days. In one of the study periods, the     behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a     hyperinsulinemic euglycemic clamp.   "
53838|NCT02580890|"     The purpose of this study is to determine whether transcranial direct current stimulation     (tDCS) is effective in the treatment attention deficit hyperactivity disorder (ADHD).      Randomized, double-blind Controlled Clinical Trial      Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria     and who agree to participate in the study Will recruit from advertisements and clinical     referrals to a PRODAH      Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is     applied for 20 min      Sham tDCS Same assembly is used Current is applied for 30 sec      Both groups 5 stimulation sessions on consecutive days      Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD     Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression   "
53839|NCT02580877|"     The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to     assess the effects of varying doses and schedules of oral insulin on immunological and     metabolic markers in relatives at risk for type 1 diabetes (T1D).   "
53840|NCT02580864|"     Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's     disease.   "
53841|NCT02580851|"     Current guidelines for the diagnosis and management of patients with stable coronary artery     disease (CAD) strongly support the performance of non-invasive imaging techniques for the     detection of myocardial ischemia prior to revascularization procedures. This recommendation     originates from the strong evidence base showing the lack of prognostic benefit from     percutaneous coronary interventions (PCI) over optimal medical therapy in patients without     verification of myocardial ischemia. On the other hand, it could be demonstrated that     patients with functionally significant coronary artery stenoses do benefit from     revascularization. Cardiac magnetic resonance imaging (CMR) has emerged to be a diagnostic     modality of choice for the detection of myocardial ischemia with high sensitivity and     specificity. The investigators therefore designed this prospective and randomized trial to     compare a CMR-driven vs. angiography-driven management of patients with stable CAD concerning     major cardiac endpoints, futile angiographies and quality of life.   "
53842|NCT02580838|"     The aim of this study is to determine whether early use of OnabotulinumtoxinA is more     effective to improve functional outcomes of upper limb in patients with stroke.   "
53843|NCT02580825|"     The purpose of the study is to explore if self biofeedback program can reduce ground reaction     force (GRF) from the lower extremity of the body and in the knee in particular and help obese     children to avoid knee injuries.   "
53844|NCT02580812|"     The purpose of the study is to determine whether perinatal listeriosis is associated with     long-term neurological consequences, and to evaluate the respective contribution of perinatal     sepsis, of prematurity and of the known neurological tropism of the involved pathogen,     Listeria monocytogenes.   "
53845|NCT02580799|"     A multi-center non-interventional, in-vitro trial for evaluation of concordance of the     results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the     Immunohistochemical (IHC) method in pathological samples collected from participants with     breast cancer.   "
53846|NCT02580786|"     This study examines if the internet-based peer support has an effect on the breastfeeding     attitude or the duration of breastfeeding in preterm infants and their mothers compared with     mothers with routine care. The factors associated with the initiation of breastfeeding in the     neonatal intensive care unit will be determined. In addition, the perceptions of the mothers     of preterm infants about their needs and problems when breastfeeding their preterm infants     are described.   "
53847|NCT02580773|"     Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD)     representing the leading cause of death and the second cause of hospitalization among adult     patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during ACS.     Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via the     alleviation of pulmonary thrombosis. The main objective of this prospective, randomized,     double-blind study is to test the efficacy and safety of a curative anticoagulation strategy     during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint is     number of major bleedings.      A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT scan     is positive (thrombosis within a large elastic artery), the patient will not be randomized     and will be treated with a curative anticoagulation. If the CT scan is negative, the patient     will be randomized to receive subcutaneous anticoagulation with low molecular weight heparin     (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day for 7 days) or at     a prophylactic dose (4500 UI/day).   "
53848|NCT02580760|"     This cross-sectional monocentric study will describe transgender men transitioning into women     and who had cosmetic silicone injection.      The principal objective is to estimate the prevalence of Transgender with circulating     monocytes containing silicone vacuoles in blood smears among Male to Female Transgender     population with a history of cosmetic silicon injections.      The secondary objectives are to describe the transgender population, to describe the quantity     of silicone in vacuoles of circulating monocytes, and the association between dermatological     complications (inflammatory and not inflammatory) and several clinical and biological     characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of     silicone which was injected , silicone quantity in blood smears).   "
53849|NCT02580747|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous or donor-derived T cells may make the body build immune response to     kill cancer cells.      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in     treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.   "
53850|NCT02580734|"     The purpose of this study is to determine whether melatonin is effective in the treatment of     burning mouth syndrome (BMS).   "
53878|NCT02580370|"     This is a safety and efficacy study of botulinum toxin type A in subjects with lateral     canthal lines.   "
53879|NCT02580357|"     The aim of this study was to compare two intensities of LLLT on wound healing process of the     donor palatine area after CTG removal.   "
53929|NCT02579707|"     This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of     AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a     2-period crossover design. PART 2 is an open-label study to determine the safety and PK     parameters of a single 1000-mg oral dose of AG-120.   "
53851|NCT02580721|"     Crestal bone and soft tissue stability around implants is an important issue in implant     dentistry. Initial vertical mucosal tissue thickness was shown to be one of the factors     having impact on bone stability. However, there is lack of data in the literature regarding     the relationship between mucosal thickness and marginal bone loss around implants. Berglundh     and Lindhe in an animal study reported that thin mucosal tissue causes significantly more     crestal bone resorption around implants. In addition, clinical research regarding the effects     of tissue thickness on bone and soft tissue stability around implants is lacking. The aim of     this clinical study is to evaluate the influence of mucosal tissue thickness on soft and hard     tissue changes around implants.   "
53852|NCT02580708|"     The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib when     administered in combination with trametinib.   "
53853|NCT02580695|"     Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health     issue since none of the current therapies are truly disease modifying. The use of mesenchymal     stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage     degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response.     Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in     knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double     intra-articular injection, re-randomized at 6 months.   "
53854|NCT02580682|"     To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on allergic rhinitis.   "
53855|NCT02580669|"     The goal of this study is to show pattern differences of vasoreactivity and connectivity     between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use     of methods of advanced brain MRIs and the Diffusion Tensor Imaging , and correlate these     differences with Clinical disability and cognitive disorder results.   "
53856|NCT02580656|"     Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in     the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors     require treatment for clinical levels of emotional distress. The investigators will conduct a     phase I open trial to test the potential efficacy of MCT in cancer survivors.   "
53857|NCT02580643|"     This study will document treatment effects, changes in quality of life, procedure     complications, adverse events, healthcare resource utilization, and further needed     intervention(s) following treatment with nSTRIDE autologous protein solution. This study will     also allow for the documentation of the same parameters following multiple injections of     autologous protein solution to treat knee osteoarthritis.   "
53858|NCT02580630|"     The purpose of this study is to compare in a randomized double blinded controlled trial the     effect of heavy slow resistance exercises combined with ultrasound guided injections with     local anesthetic with or without glucocorticosteroid in patients with achilles tendinopathy.   "
53859|NCT02580617|"     This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn'     disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal     stem cells.   "
53861|NCT02580591|"     The study will investigate the efficacy, safety, tolerability and PK of 3 doses of     empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes     mellitus as adjunctive therapy to insulin   "
53862|NCT02580578|"     This study will characterize the treatments and outcomes associated with different uterine     fibroid treatments in Canada, to understand patients' preferences and satisfaction with     different medical and procedural interventions. The study will also assess the effectiveness     of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and     symptoms, and improvement in patient's quality of life.   "
53863|NCT02580565|"     The use of analgesics can lead to cases of drug abuse and dependence. It can also cause     pseudo-addiction in patients suffering from pain. What is the actual situation in patients     suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive     crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical     Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to     differentiate the symptoms occurring only in a context of pain, in the aim of managing the     pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no     pain, and more in favour of true addiction. Currently there is no data available in France on     this problem, and no studies have been carried out in children or adolescents with     sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic     use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a     population of subjects with severe sickle-cell disease in France.      PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an     observational, descriptive and transversal study. Patients under the age of 26 with     sickle-cell disease are included in the study by the doctors looking after them in     sickle-cell disease centres. The patients are then contacted by a trained researcher for a     telephone interview, including an evaluation of the Diagnostic and Statistical Manual of     Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous     oxide and for each of the analgesic drugs taken by the patient. The data are also completed     using the subject's medical record.      This study will make it possible to provide an initial quantitative and qualitative     evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic     drugs in the sickle-cell disease population. The results will be used firstly to provide     additional data essential for monitoring the risk of overdose, abuse, dependence and misuse     of these products, and to begin awareness-raising and to provide information for health care     professionals, in order to significantly improve the management of sickle-cell     disease-related pain.   "
53864|NCT02580552|"     The primary objective of this study is to evaluate the safety and tolerability of the     investigational drug, MRG-106, in patients with cutaneous T-cell lymphoma (CTCL), mycosis     fungoides subtype. MRG-106 is an inhibitor of a molecule called miR-155 that is found at high     levels in the malignant T-cells of many mycosis fungoides patients. miR-155 may be important     in promoting the growth and survival of these cancer cells. In Part A of the study, MRG-106     will be tested by injection directly into CTCL lesions in the skin. In Part B of the study,     MRG-106 will be given by subcutaneous injection or by intravenous infusion. Other objectives     of the study are to measure the absorption and clearance of MRG-106 from the blood, and to     understand how cells in CTCL skin lesions respond when exposed to MRG-106.   "
53865|NCT02580539|"     This study evaluates the safety and efficacy of EBV-specific T-cell lines to treat patients     suffering from high EBV viral titers not responding to standard of care therapies and to     treat EBV-related lymphoma. The study will recruit 6 patients to receive autologous T cells     or a T cell line derived from the patient's allogeneic donor (in the case of stem cell     transplant recipients), and 6 patients to receive a T-cell line prepared from a matched or     partially matched related donor.   "
53905|NCT02580019|"     The study aims at estimating the safety and efficacy of the intravenous injection of human     umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in     recent 3 months.   "
53906|NCT02580006|"     This Phase I study is to compare pharmacokinetics, safety and pharmacodynamics of EPORON and     EPREX after single subcutaneous administration.   "
53868|NCT02580500|"     Pilonidal dermoid cyst surgery under general anesthesia and regional anesthesia techniques is     used.regional anesthesia techniques; spinal, epidural, spinal epidural (combined) and is the     local anesthesia.In the investigators study, pilonidal dermoid cyst surgery in spinal and     epidural anesthesia techniques activity, reliability will be compared to the side effects and     complications.      One hundred patients will be randomly assigned to either the pilonidal dermoid cyst under     Spinal anaesthesia (50 patients)(Group 1) or pilonidal dermoid cyst under epidural     anaesthesia (50 patients)(Group 2). Group 1 will be used in spinal catheter in spinal     anesthesia procedures or Group 2 will be used epidural catheter in epidural anaesthesia     procedures.All patients has symptomatic pilonidal dermoid cyst.   "
53869|NCT02580487|"     Acute appendicitis is the most common illness that brings pediatric patients to the hospital     for surgical treatment. Abdominal pain is the symptom because of which the patients go to the     hospital. Some patients have severe pain and need analgesics before the final diagnosis and     before surgery. After surgery most patient experience pain and at least 80 % of the patients     need postoperative pain medication. For two decades there has been a clinical guideline for     pain management in Kuopio University Hospital (KUH). The investigators aim was to evaluate     how well the pain management for pediatric patient works in clinical practice.   "
53870|NCT02580474|"     Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C     and chronic renal failure will be assessed.   "
53871|NCT02580461|"     The RECHARGE study is evaluating the effect of a 24 week structured exercise and education     program on the physical and emotion health, quality of life, physical activity and fitness     levels of family caregivers. Very little research has been done examining the impact of a     structured exercise program designed for family caregivers of cancer patients. The purpose of     this study is to determine if physical activity is effective in improving caregiver health     and well-being.   "
53872|NCT02580448|"     The goal of this clinical study is to determine the safety, pharmacokinetics,     pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of     CYP17, in patients with advanced breast cancer.   "
53873|NCT02580435|"     Multiple sclerosis (MS) is an inflammatory disease that affects the nervous system and     results in a wide range of signs and symptoms including physical and cognitive problems.     Recent evidence demonstrates that interactions between the host immune system and the     commensal gut microbiota have a key role in the development of the disease. However, the     natures of these interactions are poorly studied, and the set of bacteria with pathogenic or     protective potential are unknown. Here, the investigators propose a multi-pronged approach to     deciphering the role of the microbiota in MS, by developing microbiome-based machine learning     algorithms aimed at: (1) distinguishing healthy individuals from MS patients; (2) predicting     the time since the onset of MS in relation to disease activity by predicting next relapse and     neurological progression; (3) identifying microbiome signatures that characterize the relapse     state; (4) distinguishing various MS phenotypes in relation to blood and microbiome     transcriptome signatures; (5) predicting response to various immunomodulatory treatments in     relation to blood and microbiome transcriptome signatures. Overall, these studies should     establish the role of the microbiome in multiple sclerosis, resulting in a set of     non-invasive tools for characterization of the disease; identification of the kinetics of MS     using microbiome as a readout; and allowing the prediction of individuals prone to MS based     on their microbiome and in relation to their protein expression. These new set of diagnostic     and predictive tools may thus add a novel and unexplored dimension to the study of the     disease that may lead in the future to new therapeutic avenues based on designing     microbiome-targeted interventions.   "
53874|NCT02580422|"     Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance     to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary     function is not well understood. Preclinical studies demonstrated diaphragmatic muscle     wasting(29) and left ventricular wasting and fibrosis associated with mouse cachexia     models.(40) Many patients, who experience cancer cachexia, describe a generalized debility     and a sense of breathlessness(41) despite adequate oxygenation in the peripheral blood as     measured by pulse oximetry. Whether this is related to deconditioning associated with     chemotherapy or related to direct effect on cardiac and diaphragmatic muscles remains     unknown. In this pilot study, the investigators propose to perform a preliminary evaluation     of the cardiopulmonary function in patients with pancreatic cancer, who are likely to develop     cachexia, to assess for the feasibility of performing a larger prospective study to     understand the impact of cancer cachexia on cardiopulmonary function. This pilot study will     provide the foundation to potentially identify cachexia in early stages (pre-cachexia) to     develop pharmacological or exercise based interventions to prevent or delay its progression.     Based on clinical experience and published literature, it is expected that 60-70% of patients     will have >10% weight loss during the course of this disease. More commonly, this is     associated with clinical or radiographic disease progression, but certainly it can happen     throughout the course of the disease even without disease progression.   "
53875|NCT02580409|"     Rehabilitation Enhancing Aging through Connected Health, REACH, is designed to evaluate the     benefits of a novel rehabilitative care program on physical function utilizing mobile health     technology to deliver patient centered care more efficiently and health care utilization     after one year of follow up.   "
53876|NCT02580396|"     This feasibility study will be conducted in order to provide proof of concept for the     CanADVICE+® system comprising a smart phone app and a healthcare organization server side     application based on Web 2 technologies. The main objective of this project is to optimise     pharmaceutical counselling services by providing drug related information, in a digital     format, to patients with metastatic breast cancer receiving Capecitabine.   "
53877|NCT02580383|"     The investigators collected data and chart from the patients who were diagnosed facet joint     syndrome and underwent lumbar RF medial branch neurotomy between January 2009 and June 2014.      RF was performed using sensory stimulation and multifidus twitching to confirm the position     of RF needle. The patients wil be grouped according to the adequacy of RF needle position     while performing RF medial branch neurotomy ('complete' when all needles were placed     adequately, 'partial' when one of the needles for a facet joint medial branch was placed     inadequately, 'none' when there were both needles positioned inadequately for a facet joint)     The relationship between the long term effect of RF neurotomy (longer than 6 months) and the     groups will be analyzed.   "
53880|NCT02580344|"     The Copper intrauterine device is the most common method of reversible contraception     worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the     discontinuation of the intrauterine device.      Excessive prostaglandin release in the endometrial cavity appears to play an important role     in both bleeding and pain related to copper intrauterine devices.There are many types of     prostaglandin metabolites that present in the endometrium one of them is prostacyclin which     causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has     two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane     causes vasoconstriction and blood clotting.      Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting     by decreasing production of endometrial prostaglandins; they can improve both heavy uterine     bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat     heavy uterine bleeding and pain associated with copper intrauterine device use such as     mefenamic acid, ibuprofen and naproxen.      The most recent systematic review found NSAIDs is the most widely studied drugs for reduction     of the menstrual blood and pain associated with copper intrauterine device. The Cochrane     Review also found that NSAIDs are the most effective treatment to reduce the bleeding with     copper intrauterine device use.   "
53881|NCT02580331|"     Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts     differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a     favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF     gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the     treatment of Class II furcation defects in comparison with placebo gel.   "
53882|NCT02580318|"     This is a prospective cohort study. The investigators will enroll 50 healthy volunteers. In a     safe environment and after signing informed consent, each participant will consume a     standardized alcoholic beverage. Using a Breathalyzer, the subjects BAT will be measured. If     the subject's BAT is less than 0.10 +/- 0.005, the subject will drink another alcoholic     beverage. This process will continue until the subject's BAT is 0.10 +/- 0.005. The number of     alcoholic beverages the subject consumes will be monitored by the observers. When the target     BAT is reached, the subjects will manipulate the breathalyzer in various ways and measure     their BAT again after each manipulation. In a set order, the subjects will manipulate the     breathalyzer by using less than the subject's maximal exhalation effort, placing the     breathalyzer at the side of the subject's mouth, hyperventilating (10 rapidly (less than 1     second) and successive breaths prior to using the device), repeating breathalyzer 5 minutes     and 10 minutes after hyperventilation and then drinking cold water after the breathalyzer at     10 minutes and repeating the breathalyzer after drinking some cold water. Descriptive     statistical analyses as well as Pearson's product moment correlation coefficient will be     employed to determine if any statistically significant correlation exists for any of the     manipulations.   "
53883|NCT02580305|"     This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized,     parallel group, placebo-controlled study to compare the efficacy and safety of treatment with     SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable     doses of donepezil HCl and memantine HCl.   "
53884|NCT02580292|"     To determine if ultrasound measurement of renal and carotid arterial resistive indices are     associated with post-cardiac surgery acute kidney injury.   "
53885|NCT02580279|"     The investigators conduct this phase II study of EGCG therapy protection of the skin from     damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of     EGCG, investigators will utilize both clinician assessments and patient self-assessments.     Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group     (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment     Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The     scales are translated into Chinese and guides in Chinese are developed instructing how to use     the scales and perform the assessments.   "
53886|NCT02580266|"     Diabetic nephropathy (kidney problems caused by diabetes) is a devastating chronic vascular     complication of diabetes. New treatments are urgently needed for preventing or slowing down     the progression of diabetic kidney disease. Samples of serum/plasma/urine will be obtained     from patients with diabetes and different degree of renal impairment.      In this project cells in culture will be treated with plasma or serum or urine; cells     extracts or supernatant will be studied to screen for modulation (activation/inhibition) of     different cellular pathways using gene array, metabolomic and/or proteomic. Once some     cellular pathways have been identified specific analysis will be conducted on the biological     material collected to confirm specific cell signatures that could represent potential     target for treatment.   "
53887|NCT02580253|"     This study is a randomized, open-label, controlled study that will explore the efficacy of     individualized adjuvant chemotherapy based on the adenosine triphosphate tumor     chemosensitivity assay for patients with hepatocellular carcinoma after liver     transplantation.   "
53888|NCT02580240|"     The purpose of this study : 1）to determine whether hydrocortisone is effective in the     treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone     administration in septic shock patients.   "
53889|NCT02580227|"     The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss     and need for perioperative blood transfusion following intertrochanteric and subtrochanteric     femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood     clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our     hypothesis is that by providing TXA at the time of hospital admission it will decrease the     amount of preoperative and intraoperative bleeding thereby leading to a decreased need for     post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in     which half of patients will be randomized to receive TXA at the time of hospital admission     and half of patients will receive a placebo.   "
53902|NCT02580058|"     A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to     demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in     prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian     cancer.   "
53930|NCT02579694|"     The purpose of this retrospective-prospective clinical evaluation is to determine whether the     SLIC Screw System provides provisional fixation to allow biological healing of the     scapholunate interval.   "
53893|NCT02580175|"     The abortion considers the most common cause of fetal demise all over the world. The majority     of cases occur in the first trimester.The termination of abortion may be by medical or     surgical methods, however; the surgical methods represents the greater part of termination.     Therefore, the safety of this procedure is a worldwide public health concern . Many clinical     studies have been reported the safety of surgical evacuation in the first trimester.      The suction-aspiration or vacuum aspiration are the most common surgical methods of induced     abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction     using a manual syringe or electric pump. However; these technique always need cervical     dilation before aspiration. The menstrual extraction does not require cervical dilation and     can be used in very early pregnancy.      The surgical evacuation is generally considered safe, however; short-term complications are     reported due to need of dilatation of the cervix and incomplete evacuation because the     surgeon is the only one who can decide the end of the operation depending on his subjective     sense.      However; with continuous ultrasound guidance, the process could be almost complete because     the ultrasound can accurately identify the direction and size of the uterus, position of the     gestational sac, observe the insertion of surgical instruments and the advancement of the     operation especially when the configuration of the uterus is distorted.      At present; ultrasonography is not considered to be an essential pre-requisite for abortion     in all cases so our study aims to detect if complete evacuation can be achieved by     ultrasonographic assistance or not. We also tried in this study to compare the operative     time, amount of blood loss and the occurrence of accidental uterine perforation during the     procedure with and without use of ultrasound.   "
53894|NCT02580162|"     This study evaluates and compares the efficacy of professional versus peer-based delivery of     family-based treatment for childhood overweight and obesity in elementary school aged     children. Families will be randomized to receive treatment from professionals or to receive     treatment from professionally-trained peer interventionists. Some parents will then be     invited to serve as peer interventionists for the next group of families.   "
53895|NCT02580149|"     To investigate if treatment with ticagrelor can mitigate the transient loss of     endothelium-dependent vasodilatation of the resistance vasculature following a short period     of ischemia, compared with clopidogrel at standard clinical doses. The effect of ticagrelor     or clopidogrel will be studied after a loading dose and after a two weeks period of regular     intake on FBF in response to the vasodilators acetylcholine or nitroglycerin before and 10     min after a 20 min forearm ischemia, respectively.   "
53896|NCT02580136|"     The purpose of this study is to collect and organize data into a repository to gather     relevant information for future research from patients diagnosed with a rare malignant     sinonasal cancer called esthesioneuroblastoma (ENB) and are scheduled to undergo endonasal     skull base surgery. Data being collected includes surgical data, demographics, disease     presentation, MRI, CT, PET imaging, and post-operative assessments including pathology tests.     After surgery, the investigators will collect chemotherapy and radiation data. Participants     will also complete quality of life questionnaires at their follow-up visits.   "
53897|NCT02580123|"     The importance of families in the development of infants is well documented. Previous studies     found that the prevalence of overweight and obesity is growing concerns in Portugal (Padez,     Fernandes, Mourão, Moreira, & Rosado, 2004) and in the world (Ogden et al., 2014). More,     there is evidence that habits acquired in early life might track into adulthood (Lien, Lytle,     & Klepp, 2001; Lytle, Seifert, Greenstein, & McGovern, 2000; te Velde, Twisk, & Brug, 2007).     Therefore, there is a need to lock overweight and obesity in early childhood in order to     contribute to health gains during the entire life cycle. The main purpose of this research is     to evaluate the impact of an intervention program based on parenting skills and feeding     practices, on infant's growth, development and adherence to new foods in early infancy      Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized     trial and were randomly allocated to intervention and control group. Infant outcomes were     performed at baseline and post-intervention and included anthropometry, dietary assessment     and temperament. In addition maternal and family outcomes such as anxiety, dietary intake     were also assessed at both times.      An intervention program was developed and Implemented according to two terms: educators'     training with the researchers and the intervention with parents and infants developed by     trained educators. The training program was developed between December 2013 and February     2014, according to the topics of healthy eating and nutrition and development of the infant.     The control group received the standard care.      It is expected that this intervention program is able to promote healthy feeding practices to     parents and nursery teachers. The results will be disseminated to the stakeholders and     policymakers that work closely to the topic of this study. This will include papers'     publication, participation in national and international meetings, contributing to the     advance of research in this health area.   "
53898|NCT02580110|"     The study intention is to investigate, in healthy humans, effects of 3 commonly used     sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut     microbiota composition.   "
53899|NCT02580097|"     To explore Magnetic Resonance(MR) perfusion imaging as a biomarker to predict outcome of     patients with acute and subacute stroke. Contrast bolus perfusion imaging and arterial spin     labeling were conducted in included patients. Imaging evaluation of hemodynamic status,     collateral and antegrade flow were assessed. Patients were followed up to record radiological     and clinical outcome.   "
53900|NCT02580084|"     Currently, according to the TASC II consensus document (2007) and the Russian guidelines for     limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is     suggested.   "
53901|NCT02580071|"     The treatment options for high-risk acute leukemia patients are limited and these patients     are often opt for hematopoietic stem cell transplant (HSCT). However studies show that     prognosis following this last-resort therapy is bleak. At times, less than 70% of post-HSCT     relapsed AML and ALL patients even achieve complete remission; median overall survival of     these cohorts might not reach one year; and 3-year post-HSCT survival rates might be less     than 20%.      The investigators plan to recruit acute leukemia patients from CMUH which are planned to     receive HSCT, and follow the rate and quality of their immune reconstitution. As     intervention, part of the patients will receive a Chinese medicine herbal formula, which they     will take for 6 months.Differences between the 1-year post-HSCT condition of patients will be     examined.   "
53903|NCT02580045|"     This clinical trial is being done to learn more about how different types of cancer     treatments affect cancer cells when they spread to the brain. Many cancer treatments are not     able to make their way into the brain or into spinal fluid of the central nervous system.     This is because they cannot cross what is called the blood-brain barrier or BBB. The BBB     is like a protective shield that only allows certain materials pass through to reach the     brain but not others. This study is being initiated to help researchers learn more about what     types of cancer treatments make it through the BBB to attack cancer cells within the brain,     and what treatments do not make it through the BBB. Learning more about this may help future     researchers develop more effective cancer drugs that better fight cancer cells that have     spread to the brain.   "
53904|NCT02580032|"     This study is conducted in Europe and the United States of America (USA). The aim of the     study is to validate two measures for growth hormone deficiency in children, the Treatment     Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment     Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD).   "
53908|NCT02579980|"     Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot     tell if the treatment is working or not. In this research program, two techniques using     magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which     are rare cancers starting in muscle, tendons, and bones. These particular MRI tests are     called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow     visualization of how sarcomas are different from the normal organs of the body. These MRI     tests will tell us the location of sarcoma and its proximity to other structures, as well as     correlation of imaging with pathological characteristics after surgery   "
53909|NCT02579967|"     Background:      Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood or     bone marrow and given to another person. Researchers think this may help people with immune     system problems.      Objective:      To see if allogeneic blood or bone marrow transplant is safe and effective in treating people     with primary immunodeficiencies.      Eligibility:      Donors: Healthy people ages 4 or older      Recipients: People ages 4-75 with a primary immunodeficiency that may be treated with     allogeneic blood or marrow transplant      Design:      Participants will be screened with medical history, physical exam, and blood tests.      Participants will have urine tests, EKG, and chest x-ray.      Donors will have:      Bone marrow harvest: With anesthesia, marrow is taken by a needle in the hipbone.      OR      Blood collection: They will have several drug injections over 5 7 days. Blood is taken by IV     in one arm, circulates through a machine to remove stem cells, and returned by IV in the     other arm.      Possible vein assessment or pre-anesthesia evaluation      Recipients will have:      Lung test, heart tests, radiology scans, CT scans, and dental exam      Possible tissue biopsies or lumbar puncture      Bone marrow and a small piece of bone removed by needle in the hipbone.      Chemotherapy 1-2 weeks before transplant day      Donor stem cell donation through a catheter put into a vein in the chest or neck      Several-week hospital stay. They will take medications and may need blood transfusions and     additional procedures.      After discharge, recipients will:      Remain near the clinic for about 3 months. They will have weekly visits and may require     hospital readmission.      Have multiple follow-up visits to the clinic in the first 6 months, and less frequently for     at least 5 years.   "
53910|NCT02579954|"     Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary     vascular resistance inducing shortness of breath and exercise intolerance. We aim to     correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise     capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with     pulmonary arterial hypertension, and their evolution at three and twelve months.   "
53911|NCT02579941|"     Pregnancy induces a physiological change of hemostasis to a prothrombotic state : protein S     decrease and increase of virtually all the clotting factors, in particular fibrinogen, von     Willebrand factor and factor VIII. However, a state of hyperfibrinolysis may occur in the     immediate postpartum period (especially after placental delivery), thereby promoting     postpartum hemorrhage.      This state of hyperfibrinolysis is associated with the use of transfusions of blood products     and the realization of hysterectomy.It is currently the most common etiology of maternal     mortality in childbirth.There is an imperative to develop an efficient and reliable protocol     for the management of this postpartum complication.      Tranexamic acid is an anti-fibrinolytic agent (like lysine) which acts by preventing the     conversion of plasminogen to plasmin, by blocking the binding of plasminogen to the heavy     chain of fibrin.The optimal dose of tranexamic acid enabling to inhibit fibrinolysis without     increasing the complications rate remains to be defined. It is in this context that the     investigators aim to evaluate, in an in-vitro model, the minimum dose of tranexamic acid     required to inhibit fibrinolysis after activation of the latter by t-PA. The degree of     fibrinolysis will be evaluated by thromboelastometry.   "
53912|NCT02579928|"     The purpose of this study is to determine the tolerability and short-term efficacy of a     single ketamine infusion for the treatment of adolescents with 1) medication-refractory major     depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety     disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).   "
53913|NCT02579915|"     The purpose of the study is to develop a personalized, user-friendly computerized treatment     for anxiety disorders linked to primary care. The computerized treatment is a type of     Cognitive Bias Modification, which targets attention and interpretation biases known to     maintain anxiety disorders.   "
53914|NCT02579902|"     The purpose of this study is to determine whether vitamin D3 supplementation is effective in     the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to     Irritable Bowel Syndrome (IBS).   "
53915|NCT02579889|"     The study is designed as a multi-center, international, prospective, parallel, randomized,     single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal     AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed     Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or     ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or     without atrioventricular (AV) block.   "
53916|NCT02579876|"     This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy     and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis     (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.   "
53917|NCT02579863|"     The purpose of this study is to compare the efficacy of lenalidomide and low dose     dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose dexamethasone     without pembrolizumab in terms of progression-free survival (PFS) in participants with newly     diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell     transplant (Auto-SCT).   "
53918|NCT02579850|"     The aim of the present study is to evaluate the superiority of the fixed triple therapy with     BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler®     (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.   "
54002|NCT02578732|"     Preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to     FOLFIRINOX for patients with metastatic pancreatic cancer and appears to be better tolerated     with the ability to administer at least 10 cycles of therapy. Investigators therefore will     evaluate FOLFOX-A in a phase II study for patient with locally advanced pancreatic cancer.   "
53919|NCT02579837|"     Diabetic eye disease causes major vision loss in many Canadians and is costly. There are     effective preventions and treatments for diabetic eye disease but they strongly depend upon     regular screening in asymptomatic patients. The 2013 Canadian Diabetes Association (CDA)     guidelines recommend annual screening by eye care professionals, either in-person or through     interpretation of dilated pupil retinal photographs.      Despite the benefits of screening, adherence to these guidelines is poor. Reasons include     patient barriers, i.e. need for eye drops, time off work, wait times, and transportation     issues. An option to minimize these barriers is to screen using a camera called non-mydriatic     ultra-widefield (UWF) retinal imaging. This can be quickly done without eye drops on the same     day as patients' regularly scheduled diabetes clinic visits.      In this study, the investigators will compare the UWF camera to the usual screening approach     recommended by the CDA. The investigators will invite 740 patients with diabetes due for eye     screening to either be screened using the UWF camera on the day of their diabetes clinic     visit or be screened by their usual eye care professional. The investigators' prediction is     that same-day screening with UWF imaging will find more patients with diabetic eye disease     who need treatment compared to usual screening.   "
53920|NCT02579824|"     This is a 2 part study: Part 1 (dose escalation) and Part 2 (dose expansion).      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     DS-3032b that can be given to patients with multiple myeloma (MM) that is relapsed (has come     back) and/or refractory (has not responded to treatment).      The goal of Part 2 of this clinical research study is to continue to study the safety of the     highest tolerable dose found in Part 1 of the study.   "
53921|NCT02579811|"     Axitinib is a drug which is approved by the FDA for patients with advanced kidney cancer who     have already received some treatment. It works by reducing blood flow to a tumor. Axitinib is     normally give at 5mg twice per day and sometimes this dose is increased if patients tolerate     it. The purpose of this study is to figure out a different way to decide which dose of     axitinib each patient should receive based on the side effects they experience.   "
53922|NCT02579798|"     General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory     mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of     healthy patients in the minutes following the induction when a positive end expiratory     pressure (PEEP) is not used.      The functional residual capacity (FRC) of obese patients during general anesthesia is even     smaller than the one of healthy patients. There is a direct relationship between the body     mass index and the decrease of the functional residual capacity. Obese patients have     therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will     increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.      Atelectasis affect the peroperative gas exchanges and are likely to be involved in the     worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance     of secretions and the lymph flow, which predispose to lung infections.Taking all these     factors into account, it is logical to think that the atelectasis presence can lead to an     increase of the postsurgical morbidity (respiratory distress, infections). That is why     actively fighting against the formation of these atelectasis is important.      There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP     have a significant impact on the patient's postoperative status. The expected clinical     benefits balance (reduction of respiratory distress episodes, infections and mortality)     versus the risks linked to the maneuvers done to reduce the development of atelectasis     (barotraumas, cardiac complications) remains to be determined.      The primary goal of this study is to evaluate the impact of two different alveolar     recruitment strategies on the incidence of postoperative hypoxemia in obese patients after     bariatric surgery.      The secondary objectives of this study are to compare the number of recruitment maneuvers,     the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired     oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2     gradient (arterial and end tidal gradient) between two alveolar recruitment strategies     applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve     gastrectomy).      The tertiary objectives of this study are to report the number of respiratory complications     and postoperative wound infections at the 30th postoperative day.   "
53923|NCT02579785|"     The purpose of this study is to assess whether a mobile phone intervention can be effectively     used to improve post menstrual regulation contraceptive uptake and continuation in     Bangladesh.      The study will consist of two phases: Phase I: A formative phase to understand barriers to     post-abortion contraceptive uptake and continuation and the content and modality of messages     most appropriate for women in the study areas; and Phase II: An RCT will be conducted to test     the effectiveness of the mHealth intervention developed during the formative phase on     contraceptive use.   "
53924|NCT02579772|"     The main purpose of this study is to determine whether pharmacological treatment with     N-acetylcysteine improves central and peripheral cardiorespiratory control and physical     capacity in COPD patients with mild-to-moderate airflow obstruction.   "
53925|NCT02579759|"     The purpose of this study is to determine whether PXT3003 is effective and safe in the     treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will     assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated     for 15 months.   "
53926|NCT02579746|"     The study examined the feasibility of the Dietary Approach to Stop Hypertension with Sodium     (Na) Reduction for Chinese Canadian (DASHNa-CC) intervention and its potential effects on     blood pressure, health-related quality of life, and health service utilization. Half of     participants received usual care while the other half received the DASHNa-CC intervention.   "
53927|NCT02579733|"     The aim of this study is to determine whether azathioprine is effective for mucosal healing     in UC patients who achieved clinical remission by the first course of corticosteroids but not     mucosal healing in endoscopy.   "
53931|NCT02579681|"     The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment     effect on cognition over 2 year period in RRMS patients. The secondary objectives of this     study are to further assess BG00012 treatment effect on cognition, predictors of cognitive     impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue,     quality of life, and work and social life activity.   "
53932|NCT02579668|"     In the United Kingdom, the language of the Deaf community is British Sign Language (BSL). A     small proportion of Deaf young people who use BSL as their first or dominant language have     specific language difficulties and would benefit from language therapy provided in sign     language by adults who are fluent in BSL and may be Deaf. Some Deaf adults are currently     employed in education and health services to support children's BSL development. However     there is little training or information available to these adults about language assessment,     diagnosis of language difficulties or intervention strategies.      Recent studies have highlighted language difficulties and therapy in sign as an issues and     begun to explore Deaf adults understanding of language difficulties and disorder. This     project aims to extend knowledge in this area by supporting Deaf practitioners to understand     and develop language therapy skills and co-develop language therapy intervention resources.     The study will pilot training for practitioners and language therapy interventions for young     people.   "
53933|NCT02579655|"     The purpose of this study is to determine the effect of two novel interventions; (1) a     value-based formulary which eliminates copayment for selected high-value medications (proven     to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient     education program aimed at lifestyle modification and optimal drug use, combined with relay     of information on medication use, on the risk of adverse clinical outcomes (mortality, heart     attack, stroke, need for coronary revascularization, and chronic disease related     hospitalizations) in low-income seniors with chronic conditions over three years.   "
53934|NCT02579642|"     Ketamine has been used successfully as the sole medication for anesthesia in the setting of     electroconvulsive therapy (ECT), and has more recently been studied as an adjunct agent in     combination with propofol (the most commonly used anesthetic agent) to induce anesthesia for     ECT. New literature postulates an anti-depressant effect of ketamine, which in ECT     specifically may be helpful with regards to the overall goals of therapy (i.e. ECT indicated     for severe or treatment-resistant depression).      Current research focusing on ketamine with respect to its anti-depressant effect suggests it     may even represent an alternative to ECT. This study will seek to determine whether ketamine     when used in low-doses as an adjunct to propofol-based anesthesia for ECT has anti-depressant     effects and whether it influences the characteristics of recovery from anesthesia in the ECT     setting (i.e. vital sign parameters such as blood pressure and heart rate, quality of     recovery, etc.).   "
53935|NCT02579629|"     The main purpose of this study is to examine if pain levels treated with intrathecal (IT)     preservative-free morphine (PFM) after a cesarean section improve with the additional use of     continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump     system.   "
53936|NCT02579616|"     This is a multicenter, single arm, open-label study in participants with unresectable BTC and     disease progression or failure following one prior gemcitabine-based doublet chemotherapy     regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum     agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will     last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor     assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after     the Off-Treatment Visit and will continue as long as the participant is alive, unless the     participant withdraws consent, or until the End of Study.   "
53937|NCT02579603|"     This is a phase IV, twelve week, open label, randomized, parallel group study to assess     safety and tolerability of combined treatment with nintedanib and pirfenidone.      A secondary objective is to assess the exposure based on PK trough concentration values to     nintedanib either given alone or in combination with pirfenidone and to assess the exposure     of pirfenidone when combined with nintedanib.   "
53938|NCT02579590|"     Female sexual dysfunction is age-related, progressive, and very common condition. The     physiology of the female sexual function is a complex condition affected by emotional,     medical and hormonal elements.      Progestogen-only contraception relies on progestogens alone to achieve contraception. There     are several progestogen only contraceptive methods include progestogen only pill (minipill),     subdermal implants, Depo-Provera (DMPA) and levonorgestrel intrauterine system. Many studies     in literature reported the negative effect of combined oral contraceptive pills (COCs) on     female sexual function due to decrease in bioavailability of testosterone and increase level     of sex hormone binding globulin (SHBG) which leads to decrease in free testosterone level     contributes to dysfunction.      However, the progesterone only methods contains no estrogen, so it has less effect on sex     hormone binding globulin and therefore less effect on free testosterone. DMPA (injectable     progestins) is an injectable progestin is a highly reliable form of contraception. Nelson in     1996 found that about 6% of women using DMPA reported either lost or decreased libido. More     recent study by Fortenberry in 2011 reported that DMPA had no effect on sexual interest     compared with nonusers of any hormonal method of contraception in an adolescent population.     The etonogestrel implant (Implanon) is a single rod that is inserted into the medial side of     non dominant upper arm. Although in general, it is very effective and has relatively low side     effect, a decreased libido has been noted.      Cerazette is a progestogen-only contraceptive pill containing 75 micrograms of desogestrel.     It acts mainly by inhibiting ovulation. Cerazette users also may complain of decreased     libido.      The estrogen is the main hormone which responsible for vitality of the pelvic organ     especially the vagina. The main mechanism of action of the DMPA, Implanon and Cerazette is     inhibition of ovulation, which leads to decrease in the estrogen level, which causes a drop     in blood flow in uterine artery and accordingly the vagina artery. That can affect vaginal     lubrication, causing the vagina to be too dry for comfortable sex.   "
53939|NCT02579577|"     The population of children with life-limiting illnesses (LLI) in England is increasing and     there is growing need to improve the quality of children's palliative care. Families of     children with LLI are confronted with many care decisions for their children, such as whether     and when to commence artificial nutrition or ventilation. They may also have the opportunity     to consider the care that may be appropriate for their child in the future. Despite the     important decisions families and professionals are required to make, there is little     empirical evidence regarding the process of decision making and future planning for this     population. Few studies have investigated the perspectives of multiple stakeholders and none     have addressed multiple perspectives longitudinally. Therefore the relational and contextual     aspects of decision making and future planning for children with LLI have as yet not been     identified.      A multiple embedded case study utilising ethnographic methods (semi-structured interviews,     observation and notes review) is proposed to address this knowledge gap. Families of children     with LLI cared for in either of two participating hospitals will be recruited and followed up     for up to 12 months. The family will be invited to nominate 'significant others' (e.g.     relatives, friends, health care professionals) who assist them in decision making and future     planning, to participate in the study. Outpatient clinic appointments or ward rounds during     periods of hospitalisation will be observed and semi-structured interviews will be conducted     approximately three times with each participant. Medical notes will be reviewed at the end of     the study.      This research will enable a better understanding of the experiences and preferences for     engaging in decision making and future planning from the perspectives of all stakeholders. It     will also provide an awareness of the communication practices involved in discussions and the     networks of care surrounding children with LLI, including specific support needs in relation     to their role.   "
53940|NCT02579564|"     The purpose of this multi-center clinical trial is to verify more effective on local control     of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant     human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar)     compared with cisplatin perfusion, with acceptable side effects.   "
53941|NCT02579551|"     This clinical trial studies the effectiveness of narrow margins in patients with low-risk     basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the     area of normal tissue around a tumor taken out during surgery to make sure all of the cancer     is removed. This clinical trial studies tissue samples to determine the least amount of     tissue that must be removed to give an acceptable cure rate. This may allow less normal     tissue to be removed from patients and may be a less expensive surgery.   "
53942|NCT02579538|"     This observational study aims to determine the association between preoperative cognitive     flexibility and the risk of developing PPSP by preoperative administration of cognitive     tests.   "
54003|NCT02578719|"     This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine     compared to placebo in chronic migraine patients.   "
57270|NCT02535936|"     The purpose of this study is to characterize the cortical connectivity changes in the brain     of spastic diplegic children after Selective Dorsal Rhizotomy.   "
53943|NCT02579525|"     Background: The recommended monitoring and target levels in septic shock (SSC Guidelines     2012) including mean arterial pressure (MAP) target are not based on robust clinical data.      Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment     strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target     guided standard care.      Design: A prospective phase II two-parallel-group open-label randomized controlled trial      Interventions:        1. Intervention group- Targeted tissue perfusion guided (TTP) - care.        2. Control group - Macrocirculatory - guided (MCG) care.      Randomization: 1:1 stratified according to the site and presence or absence of known     hypertension.      Trial size: 200 randomised patients in 4 ICUs.   "
53944|NCT02579512|"     The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient     data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG.     Patients with suspected coronary artery disease are conventionally diagnosed and treated by     cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless     clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a     nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is     usually performed to increase the accuracy of diagnosis. But these examinations are not     accessible to all patients, and are time-consuming and costly.   "
53945|NCT02579499|"     To compare clinical safety & efficacy of fixed-high potent statin therapy (according to 2013     ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL<70mg/dL) for secondary     prevention. Total 4400 patients with coronary artery disease patients requiring statin     treatment were categorized fixed high-potent statin group and targeted LDL-C group. The     investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event     (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2.     Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism,     4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5. Aortic     intervention or operation, 6. ESRD with renal replacement therapy).   "
53946|NCT02579473|"     SER-214 is a poly (2-ethyl-2oxazoline)(POZ) polymer conjugate of rotigotine, a potent     dopamine agonist that has high affinity for the subclass of dopamine receptors in the brain     that mediate dopamine signaling. SER-214 will be administered subcutaneously once a week via     a standard 1 mL insulin syringe to determine the safety, tolerability and pharmacokinetic     (PK) profile of released rotigotine and POZ-conjugate. Subjects in this study are eligible if     they have early, stable or untreated Parkinson's disease and are still experiencing motor     fluctuations.   "
53947|NCT02579460|"     The purpose of this study is to elucidate mechanisms whereby oxidative stress induced by     acute reflux esophagitis: 1) activates p38 to regulate proteins that control the G1/S cell     cycle checkpoint, and 2) activates HIFs (hypoxia inducible factors) to cause autocrine VEGF     (vascular endothelial growth factor) signaling that triggers the EMT     (epithelial-mesenchymal-transition) program in Barrett's esophagus.   "
53948|NCT02579434|"     The study objective is to evaluate and validate of endogenous markers for the assessment of     CYP3A activity in Korean healthy subjects using metabolomics.      In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total     25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects     will be administered midazolam I.V. 1 mg.   "
53949|NCT02579421|"     The purpose of this study is to examine the role of progesterone (a naturally occurring     hormone found in both men and women) on reducing marijuana use. The investigators will see if     progesterone effects impulsivity, withdrawal, mood and stress during marijuana cessation.   "
53950|NCT02579408|"     Non-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its     presence among donors of living donor liver transplants could affect the outcomes of     recipients of liver transplantation. By using controlled attenuation parameter (CAP)     measurements, the investigators aim to investigate the association of CAP measurements and     severity of fatty liver among liver donors in the recipient outcomes of living donor liver     transplantation.   "
53962|NCT02579252|"     This study evaluates the safety and efficacy of AADvac1 in the treatment of patients with     mild Alzheimer's disease.      60% of participants will receive AADvac1 and 40% of participants will receive placebo.   "
53963|NCT02579239|"     The purpose of this study is to assess the safety and biological activity of ATYR1940 in     patients with Limb Girdle (LGMD2B) or Facioscapulohumeral Muscular Dystrophy (FSHD).   "
53964|NCT02579226|"     This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811     at increasing doses in patients with advanced solid tumours and for whom no standard of care     exists. The study will be conducted in two parts, a dose-escalation phase (Part A) and a dose     expansion phase (Part B). During Part A, the dose-escalation phase, patient enrolment will     proceed according to a 3+3 design where the maximum tolerated dose (MTD) or the recommended     Phase II dose (RP2D) will be identified. The study will also characterize the pharmacokinetic     (PK) profile of AZD2811 and will explore the potential biological activity by assessing     anti-tumour activity in patients. Part B will further explore PK parameters, safety,     tolerability, and preliminary anti-tumour activity of the AZD2811 RP2D as monotherapy (Group     1) in patients with relapsed/refractory SCLC, and when combined with irinotecan (Group 2 and     Group 3).   "
53952|NCT02579382|"     The primary objectives of this study are to evaluate the safety, tolerability, and efficacy     of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are     currently not being treated.   "
53953|NCT02579369|"     This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in     patients with Dystrophic Epidermolysis Bullosa.   "
53954|NCT02579356|"     The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having     2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days     between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a     day for 6 days.   "
53955|NCT02579343|"     This will be a randomized, single blind study of 6 weeks duration involving the use of     auricular acupuncture or sham acupuncture in the adjunctive treatment of depression in     college students.   "
54068|NCT02577874|"     This study is designed to compare the responses to an oral glucose challenge between people     of European and Chinese heritage (essential participants in the European arm must have tow     European parents and likewise for the Chinese participants).   "
53956|NCT02579330|"     In various transanal and anal procedures it is desirable to clean the operating field from     stool contamination. Thus mechanical bowel preparation is not well tolerated by patients.     Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be     performed and enable a clean operating field. In this randomized controlled trial the     macroscopic contamination of the rectum with and without Coloshield is compared using the     Boston Bowel Preparation Score (0-3).   "
53957|NCT02579317|"     Despite conscious intentions to remain abstinent, persons with substance use disorders often     find that negative emotions and environmental cues automatically trigger drinking and other     substance use. This study aims to test whether activating the baroreflex mechanism can be     used in the moment to help resist drinking triggers. It consists of 3 phases (Recruitment,     Intervention, Follow-up).      Stage 1: Trained research staff conduct a comprehensive clinical interview and questionnaires     to assess participant's mood, substance use, and triggers. Participants are paired with a     Primary Research Clinician (PRC) who will work with them during the intervention.      Stage 2: Approximately 4 weeks after intake into the Center for Great Expectations Intensive     Outpatient program, an 8-week intervention begins. Pre-and post-intervention laboratory     sessions occur at Cardiac Neuroscience Laboratory, Center of Alcohol Studies, Piscataway, NJ.     Some participants take part in pre- and post-intervention neuroimaging sessions (Rutgers     University Brain Imaging Center, Newark, NJ). Participants are randomized into an active     intervention or control group after the pre-intervention lab session. They are given an     iPhone and trained to use a paced breathing app that is pre-loaded onto the phone.     Participants in both groups use their app any time they anticipate or experience a trigger to     drink or use drugs. Participants are compensated for their use of the app and the time for     participation. To ensure that participants are correctly performing the paced breathing task,     their PRC visit with them weekly to provide coaching sessions using a computer-based     biofeedback program. During the 4th week, ECG and respiration data are collected.     Participants also complete questionnaires about mood and triggers, and provide feedback on     the usefulness of the app.      During the lab sessions, participants complete a series of questionnaires and ECG, blood     pressure and respiration are collected during four 5-minute tasks (resting baseline,     non-resonance breathing, resonance breathing, and visual processing/attention). During the     neuroimaging sessions, participants are placed in the scanner for structural scans and four     5-minute tasks (as tasks as previously noted); ECG and blood pressure are recorded.      Stage 3: Participants are re-contacted 1 and 3 months after the intervention to complete     questionnaires about their quality of life across multiple domains and the usefulness of the     app.   "
53958|NCT02579304|"     Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its     procedural feasibility and safety in a prospective series of 20 patients with diffuse     interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics   "
53959|NCT02579291|"     Individuals who had experience a stroke usually suffer from spasticity at medium and     long-terms. The presence of spasticity in the lower extremity implies several impairments for     standing and walking inducing high disability. A recent study has proposed the use of dry     needling for improving spasticity in the lower extremity. No study has investigated the     effects of deep dry needling inserted into spastic musculature in stabilometry and moto     function in patients who had experience a stroke. A randomized controlled trial investigating     the effects of the inclusion of deep dry needling into a Bobath interventional program on     spasticity, motor function and balance (stabilometry) in individuals who had experience a     stroke   "
53960|NCT02579278|"     In almost one third of patients with rectal cancer, cancer spreads through the bowel wall     into nearby veins which can be seen on MRI scans and is known as mrEMVI. It has been observed     that this is linked with worse survival due to the spread of cancer to the liver and other     organs. The investigators think that this may occur by spread of cancer cells in the blood     stream. Circulating cell-free tumour DNA (ctDNA) can be detected in the blood of patients     with both metastatic and primary carcinoma (but not healthy individuals).      This trial does not interfere with the patient's routine treatment pathway. Participants will     be chosen if they demonstrate mrEMVI on their baseline MRI scan. 20 patients who become     mrEMVI positive (following pre-operative therapy) and 20 patients who are mrEMVI negative     will have blood samples taken before and during surgery and a comparison will be made between     the two groups. If the investigators can find a link between the cancer cells seen in blood     to mrEMVI they may be able to use this test to help guide treatment in the future. This study     will serve as the feasibility of a larger, comparative study.   "
53961|NCT02579265|"     To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of     study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the     first 28 days of study treatment, confirmed by a second sample collected 7 days after the     first sample.   "
53967|NCT02579187|"     To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or     microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory     response on the basis of different clinical, radiographic, histologic and biomolecular     outcomes in post-extraction socket defects in humans.   "
53968|NCT02579174|"     1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as          computed axial tomography (CT)        2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional          alignment of Total Knee Replacement implants.        3. To evaluate differences in total knee replacement implant alignment in patients whose          arthroplasty is performed using manual or custom instrumentation derived from          preoperative CT   "
53969|NCT02579161|"     The Investigators objective is to compare the clinical efficacy of a single-day protocol with     a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly     unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further     propagation of resistant microbes.   "
53970|NCT02579148|"     The intent of this clinical study is to answer the questions: 1) is the proposed treatment     feasible; 2) is treatment effective in improving the disease pathology of patients with     diagnosed diabetic erectile dysfunction.   "
53971|NCT02579135|"     This study evaluates an educational web-based intervention designed to increase adolescent     girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health     Education and Relationship Training). Half of participants will receive Project HEART and     half of participants will receive Project Growing Minds, an attention-matched control website     focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this     work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to     avoid unplanned pregnancies.   "
53972|NCT02579122|"     In view of the fact that little is known about the pre- and post-interventional coagulation     management of phenprocoumon patients with reviparin at general practices in Germany, an     observational study is being initiated to evaluate the effectiveness and tolerability of     reviparin in the area of outpatient, general practice-based care in the context of bridging     therapy. Patients for whom bridging therapy with low-molecular weight heparin (LMWH) was     specified and for whom the LMWH reviparin was chosen for this purpose shall be investigated.   "
53973|NCT02579109|"     Introduction:      Autism spectrum disorder is characterized by deficits in three functional domains: language     and communication, social reciprocity, and the presence of restricted interests/repetitive     behaviors. There's also deficits in social cognition. When having a face-to-face     conversation, a listener not only hears what a speaker is saying, but also sees the     articulatory gestures that accompany those sounds. Speech signals needs then a multisensory     processing. Impairments in multisensory perceptual binding may be particularly relevant in     ASD, given that hallmark features of the disorder include difficulties in speech,     communication, and social interactions.      Objectives:      The investigator suggest that atypical multisensory processing in ASD may have an impact on     speech perception and social processing.      Aims:      Methods:      This pilot study measures free recall scores in 3 lists of words presentation after 30     minutes. In the first condition (CI) words are only listening. In the second condition (CII)     words are associated with a picture of a mans face. In the third condition (CIII) words are     associated with a video of a man speaking. Three lists are homogeneous form words     characteristics (lexical frequency, emotional valence norm, imageability). Participants were     7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19).      The investigator would create some new tools for exploring the treatment of a social     information. These tools should be the closest of a ecological social interaction.   "
53974|NCT02579096|"     This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum     uric acid and therefore prevent further gout attaches. These therapies have never been     compared at appropriate doses. Further, they will be study in patients with kidney disease     for the first time.   "
53975|NCT02579083|"     The purpose of this study is to assess the safety and pharmacokinetics of MB66, a monoclonal     antibody film for vaginal application that is being developed to potentially reduce the     transmission of herpes simplex virus (HSV) and human immunodeficiency virus (HIV).   "
53976|NCT02579070|"     The purpose of this study is to investigate whether regular measurement of skin foot     temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at     high risk of foot ulceration. It is planned to regularly measure the temperature of the feet     of people with diabetes who have already had a foot ulcer which has subsequently healed.     These measurements should allow the identification of hotspots on the foot and may be helpful     when advising about ulcer risk and providing preventative treatment. It is hoped to find out     whether the regular use of thermal images taken with the DFUPS device together with standard     foot treatment may reduce the number of people with diabetes developing ulcers or even     prevent foot ulcers.   "
53977|NCT02579057|"     This study evaluates the clinical efficacy of subcutaneously administered Furosemide     Injection Solution versus intravenous administration of Furosemide Injection, United States     Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated     heart failure. Half of the patients will receive a subcutaneously administered Furosemide     Injection Solution; the other half will receive an intravenous administration of Furosemide     Injection.   "
53978|NCT02579044|"     This is a phase I/II dose-escalation trial of everolimus in combination with lonafarnib in     Hutchinson-Gilford Progeria Syndrome (HGPS) and progeroid laminopathies (henceforth     progeria). The study will be conducted at a single clinical site utilizing the Clinical and     Translational Study Unit (CTSU) at Boston Children's Hospital. Lonafarnib will be     administered at doses previously established in the pediatric population and in this     population of progeria subjects. This study will first determine the dose-limiting toxicities     (DLT) and the maximum tolerated dose (MTD) of everolimus when administered in combination     with lonafarnib. It will then determine the efficacy of everolimus when administered at its     MTD in combination with lonafarnib for disease in progeria.   "
54045|NCT02578173|"     Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during     angiographic procedures. This will be a first in man prospective observational study of the     accuracy of this system to quantify contrast volume used during clinically indicated     angiography in the cardiac catheterization laboratory.   "
53979|NCT02579031|"     PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data     from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant     reduction in MACE among patients with STEMI undergoing primary PCI with newer generation     stents with enhanced biocompatibility.      The present trial aims at filling the current gap of evidence by providing randomized data to     establish the superior clinical outcome with an ultrathin strut third-generation DES with     biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing     primary PCI, compared to the current state-of-the art second-generation DES with permanent     polymer.   "
53980|NCT02579018|"     There are two major goals of this investigation. First, to develop pilot data to justify a     larger randomized clinical trial of an intervention designed to train interoceptive signals     (IS) and interoceptive responsivity (IR) in persons with Anorexia Nervosa (AN). Second, the     investigators will determine whether persons with AN have similar or different IS and IR for     heart rate while exercising as compared to age and gender matched controls.   "
53982|NCT02578992|"     The purpose of this study is to investigate two different patient's head and neck     positions(neutral head position and head-lift position) for the effectiveness of orotracheal     intubation with using the Clarus Video System (Trachway®) intubating stylet.   "
54014|NCT02578576|"     Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high     rate of postoperative anastomotic complications and recurrences. Surgery itself can influence     immunologic function and trigger inflammatory response, which may result in the flare of     Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early     flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to     the the complexity of perioperative period and dangerous of invasive examine, it is difficult     to distinguish disease flare from postoperative complications.      In this study, the investigators aim to development a diagnostic method of flare-up within     one month after surgery, which can help us to detect and then treat disease flare in time.   "
54138|NCT02576964|"     This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with     peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no     prior treatment. The anticipated time on study treatment is until disease progression, and     the target sample size is 43 individuals.   "
53983|NCT02578979|"     Paroxysmal atrial fibrillation is often undetected because characteristics such as short     duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the     bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial     fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional     24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However,     systematic review suggests Holter monitoring will identify atrial fibrillation in only an     additional 4.6% of patients, no better than detection rates observed in groups lacking     routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at     baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond     repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been     used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients     and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%)     without atrial fibrillation at baseline. The optimal investigation strategy, including     modality, duration of investigation, and patient subgroup remains undefined, not only for     efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare     systems. The objective of this project is to conduct a pragmatic multicenter randomized     controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour     Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without     atrial fibrillation identified by baseline ECG or history.   "
53984|NCT02578966|"     The purpose of this study is to compare the effectiveness of a traditional oral health     educational program and a program based on the theories of the Motivational Interview     directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and     3 years of age).   "
53985|NCT02578953|"     This will be a single center, open-label, single dose, randomized and 2-way crossover study     in healthy Japanese male subjects under fasting conditions. The study will be conducted to     determine the bioequivalence between dutasteride capsules manufactured at GSK (test product)     and dutasteride capsule manufactured at Catalent (reference product) in healthy Japanese male     subjects. Subjects will have a screening visit within 30 days prior to the first dose of     study treatment, two treatment periods separated by 28-days washout period, a re-visit 10-14     days after the second dose for the first follow-up and a second follow up via telephone 50-54     days after the second dose. The total duration of the study will be approximately 15 weeks     from screening to the second follow up.   "
53986|NCT02578940|"     The main aim is to assess the impact of using fluciclovine (18F) (as a PET imaging     radiotracer) on the clinical and treatment decision required for managing patients with     biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment     with the intention of providing disease cure. Also, this study will consolidate the     information regarding diagnostic performance of fluciclovine PET/CT in a large number of     prospectively followed patients at several centres in the UK and assess the effect of PSA     level on the likelihood of detecting cancer lesions by fluciclovine (18F).   "
53987|NCT02578927|"     The objective is to investigate whether the ingestion of green tea prior to physical exercise     improvement post-exercise hypotension (PEH). Double-blind, randomized, placebo study. Fifteen     hypertensive (53±4.5 years) performed three procedures: green tea+exercise (GT+Ex),     placebo+exercise (PL+Ex), green tea without exercise (GT). Thirty minutes after ingesting 2g     of green tea or placebo, they performed treadmill walking (60 minutes), 60 to 85% of maximum     heart rate intensity in procedures with exercises. BP was measured at rest and at every 10     minutes after exercise (60 minutes). Blood samples were taken before the ingestion of green     tea or placebo and immediately after exercise to determine Malondialdehyde (MDA) and Nitrite     (NO) dosages. Reduction of systolic BP compared with the rest, during PL+Ex recovery     procedure.   "
53988|NCT02578914|"     This is a randomized, parallel, single center, double masked, vehicle controlled study. The     purpose of this study is to determine the activity and safety of NS2 in patients with grass,     tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized     1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle     (0.0%).      Free aldehydes are thought to be related to inflammatory conditions such as allergic     conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether     it may decrease inflammation by lowering aldehyde levels.   "
53989|NCT02578901|"     The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with     tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to     primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.   "
53990|NCT02578888|"     This randomized clinical trial studies a palliative care program in improving the quality of     life of patients with high-risk gynecologic malignancies that is original or first tumor in     the body (primary) or has come back (recurrent). Palliative care is care given to patients     and their families facing the problems associated with life-threatening illness, through the     prevention and relief of suffering by means of early identification and impeccable assessment     and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a     palliative care program may help doctors learn more about patients quality of life, use of     healthcare services, and the relief of pain.   "
53992|NCT02578862|"     Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve     visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease     in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation     associated with inhaled anesthetics. This may be especially important in cases of advanced     inflammatory sinus disease, when visualization may be most compromised. The goal of this     study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled     anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.   "
54015|NCT02578563|"     To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus     patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used     hypoglycaemic drugs in real life clinical settings.      To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter     inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis     in clinical practice setting. The study would also assess treatment patterns with SGLT2     inhibitor patient relevant outcomes in whole population as well as pre identified patient     subgroups.      Primary analysis to be done at 1 year and extended analysis at 2 years.   "
53993|NCT02578849|"     The aims of this proposal include tests of hypotheses of the pathogenetic mechanisms of     noradrenergic neurotransmission in Parkinson's disease in vivo, using positron emission     tomography of patients with early and advanced Parkinson's disease with or without 3,4     L-dihydroxyphenylalanine (L-DOPA) - induced dyskinesia or co-morbid depression, and     evaluation of whether these mechanisms can be influenced therapeutically.      Hypotheses:        1. The investigators argue that release in human cortical and subcortical brain regions of          norepinephrine (NE) derived from metabolism of exogenousL-DOPA is greater in Parkinson's          disease patients with L-DOPA- induced dyskinesia than in patients without this          complication. This hypothesis will be tested by measuring antagonist [11C]yohimbine          binding to alpha-2 adrenoceptors before and after L-DOPA challenge.        2. If so, it is argued that the greater rise of norepinephrine, measured as [11C]yohimbine          displacement after L-DOPA challenge, is the result of down-regulation or loss of          norepinephrine transporters. This hypothesis will be tested by measuring the binding of          [11C]MeNER, a tracer of norepinephrine transporters.        3. If so, the investigators argue that the greater decline of [11C]MeNER binding is          significantly correlated to the symptoms of Parkinson's disease, as proof that patients          with more severe loss of noradrenergic terminals exhibit more severe motor deficits.   "
53995|NCT02578823|"     The purpose of this study is to determine whether targeted temperature management at     36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital     cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this     purpose, the current pilot study will be undertaken to establish the feasibility, safety, and     surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious     after resuscitation from IHCA.      Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or     conventional treatment group(n=20). Randomization will be performed with stratification     according to initial rhythm (shockable vs. non-shockable).   "
53997|NCT02578797|"     The purpose of this study is to determine whether daily treatment with apalutamide affects     the ventricular repolarization in participants with Castration-Resistant Prostate Cancer     (CRPC)   "
53998|NCT02578784|"     The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year     is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts     62-87%), necessitating a therapeutic measure to preserve dialysis access during this period     in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a     standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success     rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained     (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting     balloon (carrying with small knives on its surface) is performed, leading to a success rate     of 89%. However, a problem is the high incidence of restenosis, which is about 40% for     recurrent stenosis and over 10% in de novo stenosis.      The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in     the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is     unknown.      Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a     cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses     compared to the sole use of a cutting balloon.   "
54058|NCT02578004|"     Development of pressure ulcer (PU) is complex and multifactorial. The association of a     constituted PU and of clinical / biological major elements is demonstrated and justifies.     Prevention of PU is an important health priority, one that requires clear identification of     risk factors.   "
53999|NCT02578771|"     ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to     demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will     be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product     and reference positive control will be compared; ZuraPrep non-active and negative control     will be compared. Each subject will receive two of the planned treatments, one on the left     side of body and one of the right. Study duration for subjects - 3 to 4 weeks.   "
54000|NCT02578758|"     The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol     (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major depression     disorder, dysthimyc disorder, obsessive-compulsive disorder and four anxiety disorders: panic     disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) both in     terms of efficacy regarding depressive and anxiety symptomatology and its potential impact on     higher-order psychological dimensions (neuroticism/behavioral inhibition and low positive     affect/behavioral activation) in a community sample. It will also be tested the differential     effect of a specific treatment component based on positive psychology techniques in positive     affect. The main hypotheses are: 1) both modalities of the protocol (TP and TP+PA) will be     more effective than the WL condition in the primary outcome measures. Investigators also     expect scores on positive affect to be higher in the TP+PA condition than in the TP     condition.   "
54001|NCT02578745|"     Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound     therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface     - has been used to treat open wounds since the late 1990s. Experimental evidence suggests     NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing     bacterial contamination. Although effectiveness of prophylactic NPWT is biologically     plausible and non-randomized studies suggest benefit in reducing SSIs, good quality data is     lacking. The objective of this pilot randomized controlled trial of 120 patients to test the     hypothesis that prophylactic NPWT will reduce SSIs and other wound complications after     cesarean in obese women. The investigators will randomly assign obese women undergoing     cesarean delivery to Standard dressing or prophylactic NPWT with the PICO system after skin     closure. The primary outcome will be a composite of superficial or deep SSIs per Centers for     Disease Control and Prevention (CDC) criteria and other wound complications (separation,     hematoma, seroma) after cesarean.      Secondary outcomes will include wound dehiscence (≥2 cm); hematoma; seroma; composite of     wound complications; patient pain and satisfaction scores; physician office visit or     emergency department (ED) visits for SSIs; and hospital readmission for wound complications.   "
54824|NCT02568020|"     To investigate the effects of different dietary regimens on muscle wasting, insulin/IGF-1     resistance. Further, to explore whether LPD+KA decrease the activation of autophagy associate     with insulin/IGF-1 pathway.   "
54004|NCT02578706|"     Advances in antiretroviral therapy (ART) have resulted in increased survival of the     HIV-infected population; however, this gain in longevity is associated with an increased risk     of cardiovascular disease (CVD). Although ART and traditional risk factors contribute to CVD     in this population, heightened markers of immune activation, inflammation, and coagulation     independently predict morbidity and mortality, suggesting that dysregulation of these systems     plays a significant role in the increased risk of CVD. The investigators believe that     platelet activation is an important driver in HIV-associated immune activation, inflammation,     and coagulation, leading to an increased CVD pathophysiology and risk. Platelets initiate     thrombus formation and also play a key role in vascular inflammation by releasing     pro-inflammatory mediators and cross-talking with other relevant cell types including     leukocytes. Researchers have described platelet hyperreactivity in chronic HIV infection.     Importantly, the investigators demonstrated that one week of anti-platelet therapy (aspirin)     decreased platelet activation and immune activation, with an improved trend in inflammation     and immune parameters. The overall hypothesis is that platelet activation is a major driver     of immune activation, inflammation, and thrombosis in ART-treated HIV infected patients. The     purpose of the proposed proof-of-concept study is to understand the mechanism(s) by which     anti-platelet therapy improves immune and inflammatory parameters in chronic HIV infection.     To test this, the immune modulating and anti-inflammatory effects of 24 weeks of the     anti-platelet drug aspirin as compared to the anti-platelet drug clopidogrel will be     evaluated. Given their different mechanisms of action and inhibitory potency, the     investigators can differentiate whether the potential benefits are mediated via inhibition of     arachidonic acid (aspirin) or inhibition of ADP (clopidogrel) or by the antithrombotic     activity. A secondary goal is to perform multidimensional assays of platelet activity and     thrombogenicity alongside immune activation assays and careful assessments of traditional     risk factors and medication regimens, to understand which parameters are highly associated     with thrombogenicity.   "
54005|NCT02578693|"     The study is designed to provide long term clinical and virologic follow up in subjects     infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting     antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no     treatment is provided for HCV infection.   "
54006|NCT02578680|"     This is an efficacy and safety study of pembrolizumab (MK-3475) combined with     platinum-pemetrexed chemotherapy versus platinum-pemetrexed chemotherapy alone in     participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who     have not previously received systemic therapy for advanced disease. Participants will be     randomly assigned to receive pembrolizumab combined with pemetrexed and platinum     (Investigators choice of cisplatin or carboplatin), OR pemetrexed and platinum (Investigators     choice of cisplatin or carboplatin).      The primary hypothesis is that pembrolizumab in combination with platinum-pemetrexed     chemotherapy prolongs Progression Free Survival (PFS) compared to platinum-pemetrexed     chemotherapy alone.   "
54007|NCT02578667|"     Prospective cohort study. All patients presenting for percutaneous abdomino-pelvic soft     tissue ablation, biopsy, or drainage performed under the care of Dr. Issam Kably will become     part of the study population. Based on prior imaging and/or imaging at the time of the     procedure, patients will fall into two groups, those for whom no compression is necessary to     complete the procedure and those for whom compression may provide benefit. These would be     selected based on Dr. Kably's experience as a practicing academic, fellowship-trained, and     CAQ'ed interventional radiologist. The latter group would then further subdivide into those     who give consent for use of the compression device and those who do not consent. Results of     each group would be measured including the following: termination versus successful     completion of the procedure; adverse events including bleeding or damage to surrounding     structures necessitating further medical or surgical intervention.   "
54008|NCT02578654|"     A quasi-experitmental study of the efficacy interventions, including additional HIV care team     daily inpatient round and three telephone calls to remind the upcoming clinic appointment, in     improving HIV care engagement within 30 days after hospital discharge among HIV-infected     patients.   "
54009|NCT02578641|"     This study is a multi-center, randomized, open label, Phase III clinical trial.      Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving an infusion of a person's cytotoxic T lymphocytes (CTL) that have been     treated in the laboratory may help the body build an effective immune response to kill tumor     cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may     kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin     (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with     advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3     T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from     29 hospital centers across Asia and the United States.      This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38     patients at the National Cancer Centre, Singapore. This trial produced the best published     2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with     advanced NPC who received autologous EBV-specific CTL. Kindly see     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled     Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or     Locally Recurrent Nasopharyngeal Carcinoma.   "
54010|NCT02578628|"     The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving     care from Empire Physicians Medical Group (EPMG), an Independent Practice Association located     in Palm Desert, California. The system monitors routine clinical laboratory test results and     send messages to patients and providers when action is indicated, such as when tests are     overdue or results require extra clinical attention. This study will assess what happens to     laboratory results, utilization of laboratory tests, and costs of care when ther system is     discontinued.   "
54011|NCT02578615|"     The pilot study was conducted in the form of an open prospective single-arm observational     study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.   "
54012|NCT02578602|"     This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium     in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with     gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease     has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise     measurement of liver tumors than standard computed tomography (CT).   "
54013|NCT02578589|"     The purpose of this trial is to evaluate the effect of conservative treatment in comparison     to arthroscopic resection of pathological medial plicae of the knee for patients with medial     plica syndrome. The investigators expect conservative treatment to be significantly superior     to arthroscopic plica resection with regard to symptom remission and return to prior     functional level.   "
55116|NCT02564198|"     The main purpose of this study is to evaluate the safety of the study drug known as     ramucirumab in children with recurrent or refractory solid tumors including central nervous     system (CNS) tumors.   "
54016|NCT02578550|"     The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal     bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and     tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC)     (D/C/F/TAF) relative to the separate agents (DRV 800 mg tablet formulation and FTC/TAF 200/10     mg FDC) in the presence of 150 mg Cobicistat (COBI), under fed conditions, in healthy     participants.   "
54017|NCT02578537|"     Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet     inhibition than clopidogrel, which was considered more noticeable in patients with ACS     combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of     ticagrelor in the patients with CKD and NSTE-ACS has not been thoroughly studied. This study     was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to     estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet     in patients with CKD and NSTE-ACS. P2Y12 inhibitor naïve patients with CKD (eGFR < 60     ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized,     parallel-control study and randomly assigned in a one-to-one ratio to receive ticagrelor or     clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify     Now at 30 days after loading dose.   "
54018|NCT02578524|"     This study will examine patient satisfaction and spectacle independence using a survey in     patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens     at least 2 years prior to administration of the survey.   "
54019|NCT02578511|"     In this phase I study, escalating doses of IXAZOMIB will be combined with the POMP/D regimen.   "
54030|NCT02578368|"     Previously untreated patients with limited metastatic stage (see protocol for details on     criteria) will receive 4 cycles of FLOT (5-Fluorouracil, Leucovorin, Oxaliplatin and     Docetaxel). Patients without disease progression will be randomized 1:1 to receive additional     chemotherapy cycles (4-8 cycles of FLOT) or surgical resection followed by subsequent     chemotherapy (4-8 cycles of FLOT). Main objective of the study is overall survival. Most     important secondary objective is the quality of life under treatment and during follow-up.   "
54020|NCT02578498|"     No studies have investigated if the dietary composition of carbohydrate influences the     glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further,     the recommended diet composition to patients with type 1 diabetes has not been thoroughly     validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due     to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon     can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated.     The purpose of this study is to determine, whether diet composition of carbohydrate affects     the glycogen stores in the liver and affects the glucose response of glucagon during     hypoglycaemia.      HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of     low-dose glucagon is not associated with diet carbohydrate content.      AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet     influence the glycaemic response of low-dose glucagon in patients with insulin pump treated     type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks     differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose     excursions.      DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After     participants have given an informed consent, they will go through four steps: 1) screening     visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study     visit and 4) second meal intervention for one week finalizing with another study visit.   "
54021|NCT02578485|"     Background: The active video game (VGA) it has been studied how much to the physiological     factors of your practice. The objective was to determine whether an AVG session promotes     post-exercise hypotension (PEH) similar to walking exercise. Methods: Fifteen hypertensive     (49.0 ± 1.6 years), both genders performed five randomized sessions, lasting 60 minutes: 1)     AVG, 2) sedentary video game (SVG), 3) walk treadmill with moderate intensity (WMI), 4) walk     treadmill with similar intensity to VGA (WGI), and 5) control without exercise (CON).     Intensity was determined by Heart rate (HR) and Perceived Exertion (PE). Blood pressure (BP)     and cardiac autonomic modulation (CAM) measurements were taken at rest and every 10 minutes     post exercise for 60 minutes.   "
54022|NCT02578472|"     The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and     placebo, on driving performance as assessed by the mean difference of standard deviation of     lateral position (SDLP) after forced awakening using a validated driving simulator test at 2,     4, 6 and 8 hours post-evening dose.   "
54023|NCT02578459|"     The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of     pain treatment with CMM in patients with pancreatic cancer pain.   "
54024|NCT02578446|"     The optimal method of total knee replacement component fixation to the bone remains a     challenge. The use of bone cement is considered the gold standard and is the preferred     technique for most surgeons. However, uncemented fixation methods have been developed in an     attempt to tackle problems that can be seen when cement is used. The cement-bone interlock     can deform and degrade over the years and can lead to aseptic loosening, especially in young     and active patients. A loosened prosthesis results in an impaired functioning and painful     knee in daily life for which a revision of the prosthesis may be necessary. To prevent     aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have     been developed.      One of these methods is to use a highly porous metal called Tritanium®. It can improve the     biologic fixation by resembling the characteristics of trabecular bone. It is expected that     this surface aids bone ingrowth and to have similar or even better results concerning early     fixation properties and long-term durability compared with cemented fixation. Excellent     results using this highly porous Tritanium have been seen in total hip surgery already.      This single-blinded, randomized clinical trial will assess clinical and radiological outcomes     including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved uncemented     Triathlon Tritanium CR total knee prosthesis compared with a standard cemented Triathlon     metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of each 35     patients will be included.      The primary outcome measure will be prosthetic migration after two years of the uncemented     Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA.     It is hypothesized that the new uncemented Tritanium prosthesis will perform at least equally     good in terms of migration and clinical parameters compared with the standard cemented     Triathlon.      The secondary outcome measure will be long-term (10-year) survival based on the two-year     migration patterns combined with clinical factors and radiographic aspects. In order to     identify other clinical parameters besides the fixation of the prosthesis components,     clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year     results will be used to verify the predicted long-term survival results.   "
54180|NCT02576418|"     To calculate sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative     predictive value (NPV) of PartoSure TTD test in predicting delivery within 7 or 14 days from     testing and to compare it with cervical length (CL) measurement by transvaginal ultrasound     (15 mm cut-off)   "
54025|NCT02578433|"     In recent years there has been convincing evidence of the positive effects of mindfulness     based interventions, as a form of complementary and alternative medicine in regards to     subjective well-being and physical health. There is growing evidence concerning the positive     effects of these techniques in regards to an adequate stress management (e.g. respiration and     heart rate variability). These findings can be found as well documented in the literature.     For this study it is conducted to gain further insights into the role of mindfulness based     meditation techniques for psychological well-being. Therefore it is intended to focus on     clinical groups (e. g. depression and anxiety patients) in order to find out more about the     relevance of mindfulness based meditation techniques as an adjunct for psychiatric and     psychotherapeutic treatment. In this study special aspects of mental and spiritual health     (e.g. self compassion, subjective perceived stress, spiritual well-being, and psychiatric     symptoms) should be examined by comparing a group of clinical patients which practice     mindfulness based meditation once a week with a control group, practicing PMR (progressive     muscle relaxation)   "
54026|NCT02578420|"     To date, very little is known about the mechanisms of open-label placebo treatment and there     is a lack in highly controlled experimental designs. Therefore, the planned project will test     well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning     response, in an open-label placebo design, investigating their influence on placebo     analgesia.   "
54027|NCT02578407|"     This study aims to determine the treatment effect of accommodative/vergence therapy on myopic     children by assessment of accommodative function before and after therapy.   "
54028|NCT02578394|"     The aim of this study is to determine the feasibility of running a phase III double-blind,     double-dummy randomised controlled trial comparing Depo-Medrone 120mg intramuscular injection     vs. Anakinra 100mg subcutaneous injection for 5 days for the treatment of acute gout attacks     in patients with chronic kidney disease as defined by a eGFR < 60mls/min/1.73m2 and ≥     30mls/min/1.73m2.   "
54029|NCT02578381|"     Summary of Study Aims      To assess, in a randomised fashion:        1. performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire        2. performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire        3. performance of St Jude Pressure Wire versus St Jude Pressure Wire   "
54044|NCT02578186|"     The present study was conducted to investigate the impact of diphenhydramine hydrochloride on     the ability to initiate sleep.   "
55912|NCT02553772|"     This study will evaluate the safety and efficacy of a new eye drop formulation in patients     with dry eye disease.   "
54031|NCT02578355|"     The ultimate goal of this project is to develop a risk score to identify patients with     vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome.     Early identification of vulnerable plaques may have an enormous impact on public health     through primary and secondary prevention of acute myocardial infarction.      Investigators hypothesize that a risk score that incorporates non-invasive coronary CT     imaging (calcium score and/or coronary CTA) in combination with clinical characteristics     (classical risk prediction models) will improve the identification of patients who are at     highest risk to suffer myocardial infarction or sudden cardiac death.      The overall goal of the OPeRA project is to develop, implement and validate a novel risk     assessment tool based on image markers and clinical characteristics to identify patients who     are at increased risk to suffer myocardial infarction or sudden cardiac death.   "
54032|NCT02578342|"     The aim of the study is to investigate the response on cognitive testing of healthy persons     compared to adults with or without medication against ADHD.   "
54033|NCT02578329|"     The purpose of this study is to determine whether a Mediterranean Diet, personalized in terms     of total calories, total lipids and balanced in terms of saturated, mono- and     poly-unsaturated lipids, corrects the adverse fatty acid profile of patients with CHD and     reduces markers of oxidative stress and inflammation more effectively than a low-fat dietary     advice.   "
54034|NCT02578316|"     The purpose of this study was to determine the metabolism and elimination of 14C-lenvatinib     in participants with advanced solid tumors or lymphomas, who were unsuitable for, or had     failed, existing therapies.   "
54035|NCT02578303|"     Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the     occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or     cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per     hour of sleep. OSA patients often report cognitive complaints.      About 25% of the elderly population is affected by this syndrome with a drastic increase of     this rate among dementia patients. OSAS is considered to be an important risk factor for the     development of hypertension, heart disease and stroke.   "
54036|NCT02578290|"     The goal of the study is to determine whether clinical decision support (CDS) affects the     number, type, or appropriateness of targeted high-cost radiology images (i.e. MR and CT)     ordered. The CDS will be delivered in Epic through ACRSelect software, which is a leading     decision support tool based on the American College of Radiology (ACR) Appropriateness     Criteria (see http://www.acr.org/Quality-Safety/Appropriateness-Criteria), and presents the     ACR appropriateness scores for each image on a scale of 1-9 with 1-3 labelled as 'usually not     appropriate', 4-6 'May be appropriate', and 7-9 'usually appropriate'.   "
54037|NCT02578277|"     The purpose of the study is to study the effects of BMS-955176 on the single-dose PK     parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole,     midazolam, digoxin, and pravastatin   "
54050|NCT02578108|"     Chronic painful knee OA is a major cause of disability in older adults. In patients whose     symptoms are refractory to conservative management but who do not wish to undergo TKA or,     alternatively, are not operative candidates, genicular nerve RFA represents a promising     treatment option.      Investigators will determine if patients with chronic painful knee osteoarthritis experience     meaningful and long-term improvement in pain, function, and analgesic use, as well as     prevention of TKA after RFA of the genicular nerves. Investigators will also determine     whether zero versus one set of diagnostic genicular nerve blocks      Answering these questions will help determine if genicular nerve RFA is indeed a worthwhile     treatment for chronic painful knee OA. Additionally, this will help determine the optimal     diagnostic protocol for patient selection for this procedure, which has implications for     improving treatment success rates, preventing unnecessary procedures, and decreasing     healthcare cost savings.   "
54038|NCT02578264|"     The study aims to provide a more complete characterization and understanding of the genetic     causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this     study will be used to develop early detection tests for colorectal cancer that are minimally     invasive (based on a blood test). It is hoped that reliable, minimally invasive, early     detection methods will lead to improved screening rates, increased screening safety, longer     colorectal cancer survival, and overall cost savings.      In order to assess the test's ability to detect tumor DNA, 25 participants with known     colorectal cancer who will be undergoing surgical resection of the colon as part of their     clinical care will be recruited. The investigators will collect blood from participants prior     to surgery, tumor and normal tissue removed during surgery, a series of blood samples after     surgery for up to one year and relevant medical records. DNA variants identified in blood     will be compared against tissue samples. Serial samples will be analyzed to assess the     variance in amount of circulating tumor DNA across time with standard treatment.   "
54039|NCT02578251|"     The aim of this study is to assess whether paracetamol is as effective as pethidine for     analgesia during the first stage of labor.   "
54040|NCT02578238|"     This study is a non-interventional, observational study of Humira® in the treatment of     pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be     conducted in institutions which provide a written agreement to AbbVie Korea, and where the     use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric     patients who are prescribed Humira® as per physician's medical judgment in accordance with     the approved Summary of Product Characteristics (SmPC) will be enrolled in the study. As this     is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug     is being used according to the approved marketing label and is to be prescribed by the     physician under usual and customary practice of physician prescription.   "
54041|NCT02578225|"     This study, which will be conducted at 23 sites representing the determined NUTS-1 regions in     Turkey, in which all patients who were admitted to clinic or were hospitalized with Heart     Failure (Acute or Chronic) diagnosis will be enrolled into the study, for a month and on a     day of the week which will be determined by the site itself, is a national, multi-center,     observational, epidemiological and cross-sectional study. This study is a local study which     is planned to be conducted only in Turkey. Included patients of the study will be clinically     evaluated by the physicians who are maintaining them and will receive the standard medical     treatment which is determined by their physicians in normal life conditions. No experimental     intervention or treatment will be received by patients in relation to the enrollment to this     study. Therefore, this study does not contain a protocol or a pre-determined visit flowchart.     However, patients with Heart Failure diagnosis should grant their consent to the     retrospective utilization of their data and questions which will be asked to them about their     disease history. Provided that the study's design is non-pharmacological observational,     investigators will treat and follow the patients in accordance with their own medical     decisions and their best clinical experiences.      Snapshot Evaluation of Heart Failure in Turkey: Initial Analysis from SELFIE-TR   "
54042|NCT02578212|"     In the proposed study, investigators aim to investigate the role of interpersonal trust in     the conditioned placebo analgesia process with healthy male subjects in a standardized     experimental heat pain paradigm.   "
54043|NCT02578199|"     Motivational interviewing and nutritional counseling for weight loss in primary care.   "
54046|NCT02578160|"     This will be a randomized, controlled, parallel-group clinical trial. The aim of this study     will be to evaluate the effectiveness of Tell-Show-Do Behavior Management Technique versus     a Conventional technique (covering the patient's vision) during an inferior alveolar and     lingual nerve block in preschool children referred for treatment at the School of Dentistry,     University of Sao Paulo, Brazil. The sample will consist of 52 children from 3 years old to 5     years 11 months old who need dental pulp treatment and / or tooth extraction of primary     molars. Preschool children with no history of allergies to Lidocaine anesthetic or     systemic/neurological diseases and who did not take local anesthesia before the study will be     include in this research.   "
54047|NCT02578147|"     The purpose of this study is to have girls play new computer games designed for middle school     children and not yet available to the public. The investigator wants to know what girls think     about these games. The investigator also wants to learn about the health behavior of 7th     grade girls of Hispanic/Brazilian/Latino origin, and the investigators want to test the     Mighty Girls program in Miami. Half of the girls in JUEGA will be given the Mighty Girls     program and the investigators want to know if this program reduces behavior that puts girls     at risk for having sex, drinking, and using drugs. The program tries to reduce this risk by     helping girls learn skills to make wise choices, even when their friends have other ideas or     want them to make more risky choices This goal is important because US statistics indicate     that Hispanic teens are at risk for teen pregnancy and Miami has one of the highest HIV and     AIDS rates in the United States. The investigator wants to find out whether the Mighty Girls     program is as effective in Miami-Dade County Public Schools as it was when tested in one of     Orlando's Orange County Public Schools.   "
54048|NCT02578134|"     Scientific evidence of conservative management of individuals with plantar fasciosis is     sometimes conflicting. There is evidence that regular exercise programs are effective for     this pain condition. The inclusion of other therapeutic modalities is still controversial.     Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe     useful for the management of chronic tendinopathies; however, no study has investigated the     potential placebo effect of this intervention. The objective of this randomized clinical     trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus     sham US-guided percutaneous electrolysis for the management of patients with plantar     fasciosis for pain, function, and disability.   "
54049|NCT02578121|"     The purpose of this study is to determine the efficacy of Ixazomib when combined with     Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed     Multiple Myeloma   "
54051|NCT02578095|"     This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to     investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.      Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be     eligible for participation 3-7 weeks post-injury.   "
54054|NCT02578056|"     Pelvic organ prolapse (POP) is a public health problem worldwide, affecting about 30 %. It     implies physical, psychological and social losses. A frequent complication after surgeries     for POP is developing de novo stress urinary incontinence (SUI). SUI and POP have similar     pathophysiology and therefore it is common to coexist in the same patient. De novo SUI has a     prevalence 11-44 % after surgical correction of genital prolapse. Occult urinary incontinence     (OUI) is considered the major risk factor for postoperative SUI. Studies on this topic show     conflicting results. In a recent meta-analysis on this subject, Maher et al concluded that     the value of performing any anti- incontinence procedure in continent women undergoing     prolapse surgery remains unknown.      The aims of this study are to evaluate whether the association of a transvaginal tape (TVT®)     in continent patients undergoing surgery for prolapse decreases the risk of de novo SUI and     if it implies an improvement in their quality of life. The secondary endpoints are to assess     the complications associated with this procedure, as irritative symptoms and voiding     dysfunction postoperatively and assessing the ability of stress testing with reduced POP and     urodynamics in predicting the risk of de novo SUI. This study will be a prospective,     multicentric, randomized experimental study.      Patients with anterior or apical prolapse stages 3 and 4 (POP - Q) will be invited to     participate in the study. The study will assess these patients for staging of prolapse, the     presence of occult urinary incontinence and quality of life. Selected patients will be     randomized to perform correction of genital prolapse and prophylactic anti-incontinence     procedure or correction of genital prolapse only. Patients will be assessed 3, 6 and 12     months after surgery. Postoperative evaluation will be similar to preoperative. The exclusion     criteria are: complaint or diagnosis of stress urinary incontinence before reduction of the     prolapse, previous surgery for incontinence or pelvic organ prolapse, hypocontractility     detrusor in urodynamics and inability to understand and give informed consent.   "
54055|NCT02578043|"     The objectives of this study are to evaluate the therapeutic equivalence and safety.   "
54056|NCT02578030|"     To provide additional, required information on the pharmacokinetic profile of SHP465 in the     targeted population (children and adolescents aged 6-17 years of age with ADHD).   "
54057|NCT02578017|"     HU is an FDA approved medication for the treatment of SCD. Many studies have shown that HU     can reduce SCD related symptoms, but only 50% of patients take it as often as they should.     This limits how much HU can help reduce SCD symptoms.      Researchers are interested to see if electronic directly observed therapy (Mobile DOT), a     program that uses cell phone reminder messages, videos, feedback messages, and incentives     will help patients with SCD take HU as prescribed.   "
54061|NCT02577965|"     Recent studies suggest important gender differences in the pathophysiology and prognosis of     ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled     study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus     formation in patients presenting with STEMI treated with primary angioplasty. Gender-related     mechanisms of plaque rupture or erosion will be investigated using a combination of     Quantitative Coronary Angiography (QCA), high resolution Optical Coherence Tomography (OCT)     of the culprit vessel and histopathology analyses of thrombus aspirates of the infarct     related lesion, performed by independent core laboratories, blinded to group (male or female)     and clinical variables.      In OCTAVIA; enrollment in a 1:1 ratio according to gender group will be ensured by a     computer-assisted matching algorithm for gender and age (< 50, 51-70, and > 70 years).     Matching has the purpose to enable enrollment of an even number of male and female patients     in balanced age groups. This type of dynamic algorithm is appropriate when the composition of     the referral population is not known in advance.      The sample size for the OCTAVIA study was calculated on the basis of per patient stent strut     coverage (a continuous variable with right skewed distribution) with mean of 97.0% and     standard deviation of 4.0% in men, versus mean of 95.0% and standard deviation of 4.0% in     women, following XIENCE PRIME™ Everolimus Eluting Coronary Stent System implantation. Thus,     aiming for a 5% 2-tailed superiority alpha, an 80% power, and assuming a 1:1 enrollment     according to gender, a total of 64 patients per group should be enrolled. Anticipating a 10%     dropout rate due to patients lost to follow-up and inadequate imaging (included major side     branch sections), the total enrollment is set at 70 patients per group (total population of     140 subjects).   "
54062|NCT02577952|"     Lipodystrophy Connect is an online survey tool designed to collect demographic data and     health information from individuals with Lipodystrophy.   "
54063|NCT02577939|"     The primary objective of this study is to demonstrate the efficacy of a pre-transplant,     interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak)     scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is     feasible in this population. Secondary objectives include documenting the safety of IET in     this population, evaluating the correlation of VO2peak with other methods of measuring     pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD) pre     and post IET, and establishing the feasibility of the 6MWD when performed unsupervised by a     health care professional.      Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full     intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise     intervention by their treating physician. The investigators will enroll no more than 50     patients onto this trial. Results of this study will inform a randomized, multi-site study of     a pre-transplant exercise intervention.   "
54064|NCT02577926|"     The Philadelphia chromosome negative myeloproliferative neoplasms (MPN) comprise a group of     clonal hematological malignancies that are characterized by chronic myeloproliferation,     splenomegaly, different degrees of bone marrow fibrosis, and disease-related symptoms     including pruritus, night sweats, fever, weight loss, cachexia, and diarrhea. In addition,     due to elevated numbers of leucocytes, erythrocytes and/or platelets, the disease course can     be complicated by thromboembolic disease, hemorrhage, and leukemic transformation as well as     myelofibrosis.      Patients with polycythemia vera (PV) typically harbor an increased number of blood cells from     all three hematopoietic cell lineages due to clonal amplification of hematopoetic stem cells,     while patients with essential thrombocythemia (ET) typically show a predominant expansion of     the megakaryocytic lineage. Most patients with PV below the age of 60 years are currently     being treated with acetylsalicylic acid +/- phlebotomy only, and patients with low-risk ET     have an almost normal life expectancy and often do not require specific treatment. However,     PV- as well as ET-patients with a higher risk for complications require cytoreductive     treatment. In addition, constitutional symptoms can be unbearable to patients even in the     absence of bona fide high risk factors, and these patients may similarly benefit from     antineoplastic therapy.   "
54065|NCT02577913|"     This study compares the risks of short- and long-term use of FC Patch Low with     levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population     representative of the actual users of the individual preparations. FC Patch Low is a     transdermal contraceptive patch applied once a week for three consecutive weeks followed by a     break of one week (21/7). One patch contains 2.1mg gestodene and 0.55mg ethinyl estradiol,     which is equivalent of releasing 0.06mg gestodene and 0.013mg ethinyl estradiol per 24 hours.   "
54066|NCT02577900|"     The purpose of this study is to determine whether nanocrystalline silver dressing, manuka     honey dressing and conventional dressing are effective in the treatment of diabetic foot     ulcer.   "
54067|NCT02577887|"     The purpose of this study is to characterize the utilization of diagnostics capabilities in     St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.   "
54069|NCT02577861|"     The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first     treatment in patients suffering from moderate to severe LSCD (Limbal Stem Cell Deficiency)     secondary to ocular burns. In case of failure of the treatment and upon clinical indication     of the Principal Investigator, a second transplant with Holoclar will be offered if     eligibility will be confirmed. The efficacy of two treatments with Holoclar at one year after     the last treatment will be also evaluated. All patients will be followed-up for 12 months     after each implant to determine the treatment efficacy by an Independent Assessor.   "
54070|NCT02577848|"     The investigators planned to evaluate the effects of liraglutide on left ventricular function     in patients with non-ST-segment elevation myocardial infarction (NSTEMI).   "
54080|NCT02577718|"     The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a     non- antibiotic chelator based lock solution that contains nitroglycerin in combination with     sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated     bloodstream infection (CLABSI).        -  The primary objective of this study is to evaluate the safety and estimate the rate of          adverse events associated with the NiCE lock solution.        -  The second primary objective is to estimate the rate of CLABSI in patients receiving the          NiCE lock solution.   "
54093|NCT02577549|"     This study aims to develop and demonstrate the effectiveness of a systematic, practical,     cost-effective diet-induced weight loss and exercise intervention in both urban and rural     communities that can reduce pain and improve other clinical outcomes in knee OA patients.     This pragmatic community-based trial will determine if the investigators previous findings     translate to real-world settings and will address common concerns about barriers to     effectiveness/ implementation.   "
54071|NCT02577835|"     This Registry is an investigator-initiated, international, multicenter, observational,     prospective study aiming at: i) evaluating non-invasive 24-h ambulatory blood pressure and     arterial stiffness estimates (through 24-h pulse wave analysis) in hypertensive subjects; ii)     assessing the changes in estimates following treatment; iii) weighing the impact of 24-h     pulse wave analysis on target organ damage and cardiovascular prognosis; iv) assessing the     relationship between arterial stiffness, blood pressure absolute level and variability, and     prognosis. Approximately 2000 subjects, referred to 20 hypertension clinics for routine     diagnostic evaluation and follow-up of hypertension, will be recruited. Data collection will     include ambulatory blood pressure monitoring, performed with a device allowing simultaneous     non-invasive assessment of blood pressure and arterial stiffness, and clinical data     (including cardiovascular outcomes). A web-based telemedicine platform will be used for data     collection. Subjects will visit the centers at 6-12 month intervals. First follow-up results     are expected to be available in the next 2-years. The results of the Registry will help     defining the normalcy thresholds for current and future indices derived from 24-h pulse wave     velocity, according to outcome data. They will also provide supporting evidence for the     inclusion of such evaluation in recommendations on hypertension management.   "
54072|NCT02577822|"     The purpose of this study is to determine the viability of short femoral stems as an     alternative to standard-length stems in total hip arthroplasty.   "
54073|NCT02577809|"     This is an interventional drug trail to evaluate the effect of different intrathecal opioids     on post-operative pain experiences in women who have undergone caesarean section surgery.   "
54074|NCT02577796|"     Radial artery access is increasingly becoming popular among interventional cardiologists for     patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography secondary     to its low complications rates. However, it is frequently associated with the spasm of the     radial artery which can lead to difficulty in catheter manipulation during the procedure and     potentially leading to vessel trauma. This vessel trauma can cause activation of coagulation     system and formation of clot and subsequently the occlusion of radial artery. In this study     the investigators intend to find the association of radial artery spasm with the future     development of radial artery occlusion in patients who undergo PCI via radial access.   "
54075|NCT02577783|"     The purpose of this study is to determine whether doxorubicin hydrochloride liposome is     superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient     with initially diagnosed multiple myeloma.   "
54076|NCT02577770|"     This is a single center, double blind, randomized, parallel-group study to assess the effect     of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human     pain model.   "
54077|NCT02577757|"     Proceed to an analysis of sensitivity and specificity results of the fMRI language network     obtained in two ways: by providing a conventional language test and independent component     analysis. These two methods will be compared to the reference method what the cortical     intraoperative mapping.   "
54078|NCT02577744|"     Obesity is a non-communicable chronic disease of multifactorial, involving biological,     historical, ecological, economic, social, cultural and political. Currently, bariatric     surgery is considered an effective method of refractory obesity treatment, and only severe     obesity effective treatment that leads to reduced long-term weight. It is well documented in     the literature regarding the association of abdominal surgery and the incidence of     respiratory complications and its main characteristics are: atelectasis, pneumonia,     respiratory dysfunction and pleural effusion. All these respiratory complications can be     minimized or avoided with the use of a respiratory therapy care protocol, since the pulmonary     atelectasis is considered the main cause of complications. An arsenal of resources to     physical therapy lung expansion, among these, the application of positive pressure through a     valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive ventilation, and     aims to prevent and / or improve the complications resulting from postoperative. The     electrical impedance tomography (EIT) is an alternate to allow assessment of the respiratory     system, without suffering the same interference conditions of patients, such as pain and bed     rest. TIE consists of a method that measures passively regional lung ventilation. The aim of     this study is to compare the effects of the application of EPAP and NIV on pulmonary     ventilation we post bariatric surgery. This is a randomized controlled trial where patients     will be divided into two groups: EPAP and NIV and assessed by spirometry, manometer and TIE.     The techniques will be applied in the 1st and 2nd postoperative day where they will be     evaluated before, during and after the application of the techniques.   "
54079|NCT02577731|"     Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a     substantial economic and health care burden. Despite decades of promising preclinical and     clinical investigations in trauma, investigators understanding of these entities is still     incomplete, and few therapies have shown success. During severe trauma, bone marrow     granulocyte stores are rapidly released into the peripheral circulation. This release     subsequently induces the expansion and repopulation of empty or evacuated space by     hematopoietic stem cells (HSCs). Although the patient experiences an early loss of bone     marrow myeloid-derived cells, stem cell expansion is largely skewed towards the repopulation     of the myeloid lineage/compartment. The hypothesis is that this 'emergency myelopoiesis' is     critical for the survival of the severely traumatized and further, failure of the emergency     myelopoietic response is associated with global immunosuppression and susceptibility to     secondary infection. Also, identifying the release of myeloid derived suppressor cells     (MDSCs) in the circulation of human severe trauma subjects. This process is driven by HSCs in     the bone marrow of trauma subjects. Additionally, MDSCs may have a profound effect on the     nutritional status of the host. The appearance of these MDSCs after trauma is associated with     a loss of muscle tissue in these subjects. This muscle loss and possible increased catabolism     have huge effects on long term outcomes for these subjects. It is the investigator's goal to     understand the differences that occur in these in HSCs and muscle cells as opposed to     non-injured and non-infected controls. This work will lead to a better understanding of the     myelopoietic and catabolic response following trauma.   "
54157|NCT02576717|"     The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with     relapsing multiple sclerosis.   "
74487|NCT02310776|"     Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional     handheld (HH) breast ultrasound (US) exam.   "
54081|NCT02577705|"     The goals of the The Building Wealth and Health Network (The Network) are to develop and     rigorously test an asset building model that will build financial, social and human capital     through asset building, financial education and trauma-informed peer support. Program     components include: 1) Matched savings accounts; 2) Financial literacy classes; and 3) Peer     support groups using the Sanctuary ® trauma-informed approach to social services. This     program is offered in partnership with the Department of Public Welfare of the Commonwealth     of Pennsylvania. The program elements will fulfill work requirements for the program called     temporary Assistance for Needy Families (TANF).      The hypothesis is that the program's combination of services will result in improved economic     security through boosting income, increasing assets, and building a supportive social     network, that then translates to better health outcomes.   "
54082|NCT02577692|"     High inspiratory oxygen fractions are known to induce oxidative stress and lipid     peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in     part volatile and appear in breath where they can be measured non-invasively. However, there     is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.      This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative     stress in healthy volunteers. The primary outcome is the appearance of exhaled breath     biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry.     Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship     to breath biomarkers.   "
54083|NCT02577679|"     The aim of this case control study is to explore the possible association between periodontal     destruction and serum anti-CCP antibodies in RA patients and healthy subjects.   "
54084|NCT02577666|"     A dearth of information is available regarding how best to intervene with substance use     disordered homeless mothers and their young children. This proposal follows from the     promising findings of a rigorously developed ecologically based treatment that offers a     comprehensive intervention for the multiple needs of this vulnerable population. Such     research attention is needed in order to effectively intervene in the substance use, HIV     risk, mental/physical health and homeless trajectory of these women and their young children.     Further, if successful, this intervention may be transportable to communities without crisis     shelters and to homeless mothers who do not access shelter or residential treatment services.   "
54085|NCT02577653|"     Determine the posturographic characteristics of eccentric, isometric and concentric movements     in healthy subjects as well as in subjects with chronic, orthopedic conditions / pain not     involving the lower extremities. The squatting movement (going down from a stand up position,     bending the ankle, knee and hip joints, and then returning to the stand up position, while     not lifting the feet from the supporting ground surface) is a simple motion that involves all     three types of movements: eccentric (the going down), isometric (holding the down position     for a couple of seconds) and concentric (the coming up). It is hypothesized that non-healthy     subjects will not have smooth movements, and posturography could be used to separate     between healthy and non-healthy subjects.   "
54086|NCT02577640|"     Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects     of Food Innovation Science on Gastrointestinal Disease   "
54087|NCT02577627|"     This is a retrospective observational, open label study to evaluate and prospectively     validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in     individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer,     Castration-Resistant Prostate Cancer, Breast Cancer & Colon Cancer under the treatment with     the mono- and combination drug protocols for the 1st and 2nd line treatment, approved to the     market as a Standard of Care   "
54088|NCT02577614|"     The purpose of this pilot study is to evaluate the feasibility of the prophylactic     administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of     cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to     demonstrate the potential role of FEIBA administration in reducing the need for allogeneic     transfusion to treat refractory coagulopathy in high risk patients.   "
54090|NCT02577588|"     The study Phase I trial of Adoptive T cell Therapy with Activated P53 specific T cells for     Treatment of Advanced Colorectal Cancer is an open label, single arm trial.   "
54216|NCT02575937|"     The purpose of this study is to investigate the efficiency of nutrition education-based low     glycemic diet intervention on community diabetic patients.      Design: Randomized clinical trial.      Main measures: HbA1c,fasting blood glucose(FBG),2 hours postprandial blood glucose（2hPG）   "
54091|NCT02577575|"     In this study, investigators will examine the behavioral effects and neurophysiological     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset     schizophrenia. Such research is a necessary first step towards identifying whether intranasal     oxytocin administration can serve as an adjunct treatment for social impairments in     schizophrenia.      Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in     patients with recent-onset schizophrenia.      Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition     (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved     in emotional or sarcastic communication) after administration of oxytocin versus placebo.      Hypothesis B: Patients and healthy comparison subjects will show increased attention to     others' eyes and patients will exhibit increased facial affect expressivity after     administration of oxytocin versus placebo.      Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in     schizophrenia (PNS) activity in patients with recent-onset schizophrenia.      Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS     activity during social tasks after administration of oxytocin versus placebo.      Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social     cognition and behavior will be predicted by the degree to which oxytocin increases their PNS     activity.   "
54092|NCT02577562|"     The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation     approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA     Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.   "
54094|NCT02577536|"     PregSource uses a crowd-sourcing approach, asking pregnant women to enter information     regularly and directly about their pregnancies throughout gestation and the early infancy of     their babies into online surveys and trackers via a website and/or mobile application     (app). In exchange, participants can track their data over time, print out reports to share     with their healthcare team, and see how they compare to other women. In addition, PregSource     will provide participants with links to trusted, evidence-based information about pregnancy     management, issues, and complications.   "
54095|NCT02577523|"     This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects     with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC     infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as     a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will     undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient     treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of ND0612H     continuous SC infusion. Subjects will then continue on a maintenance dose of the assigned     ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after     the last SC administration of the study drug for a total of about 2.5 months of participation     for each subject enrolled into the trial.   "
54096|NCT02577510|"     Background      The sensation on the outside of portion of our thighs is provided by a nerve called the     lateral femoral cutaneous nerve (LFCN). The investigators can inject freezing around the     nerve to reduce the feeling around the thigh (i.e. anesthesia). Anesthesia, or freezing, of     the lateral femoral cutaneous nerve can reduce pain for patients having A) hip and knee     surgery [1,2], B) removal of a skin graft [3], and C) wound care. In addition, damage to the     LFCN (i.e. Meralgia Paresthetica) has been associated with body armour and gun belt use in     military and police personnel [4]. Although generally a benign condition, compression or     injury to this nerve can be painful and require treatment. In addition, the actual     variability in sensory distribution for this nerve has not been elucidated in a topographical     fashion and will be measured in this study.      Finding the most efficient and effective method for anesthesia of the LFCN can improve and     positively impact the quality of pain control for patients. Ultrasound has improved the     accuracy and efficiency of various other regional anesthesia techniques, and could also     impact the safety. Therefore the investigators hypothesize that ultrasound guided lateral     femoral cutaneous nerve block using the subinguinal technique will be statistically more     efficacious and efficient when compare to neurostimulation based blockade.   "
54097|NCT02577497|"     The primary objective of the study is to show that ventilation heterogeneity identified by     hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite     guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not     eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation     heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry     powder).   "
54098|NCT02577484|"     This study will assess the differences between Fractional Flow Reserve (FFR) measurements     made by the Navvus catheter and a commercially available pressure guidewire in up to 240     subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment     according to clinical indications and center standard practice.   "
54099|NCT02577471|"     In this prospective study the function of gastrointestinal tract was assessed using     constipation questionnaire (Rome criteria and bowel function index).   "
54100|NCT02577458|"     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability,     Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese     Patients With Advanced Renal Cell Carcinoma.   "
54101|NCT02577445|"     The aim of this post market study is to assess the impact of sleep-disordered breathing on     the well-being of patients according to the treatment chosen, i.e. with or without     implantation of the remedē® system to treat sleep-disordered breathing.   "
54139|NCT02576951|"     The purposes of this study are:        -  To evaluate tolerability of the LY2951742 solution injectable formulation (Part A)        -  To measure how much of the LY2951742 lyophilized (freeze dried) injectable formulation          is absorbed into the blood stream and how long it takes the body to get rid of it          compared to the LY2951742 solution injectable formulation after a single injection under          the skin (subcutaneous [SC]) (Part B).      Information about any side effects that may occur will also be collected. Each part of the     study will last about six months. Participants may only enroll in one part.   "
54140|NCT02576938|"     The purpose of this study is to evaluate the safety and effectiveness of baricitinib in     eczema.   "
55176|NCT02563418|"     The purpose of this study is to know the limits of feasibility of a reliable oculomotor     record for patient with Huntington's disease.   "
54102|NCT02577432|"     Background: Poor spinal anaesthesia block is common and is difficult to manage; so a     technique to minimize its incidence is advisable. Hypotension is the commonest problem with     spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes,     fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of     administration as either bolus or infusion is still a matter of debate.      Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl     separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.      Design: A randomized, controlled clinical trial.      Setting: Single medical center from 5/2013 to 10/2014.      Patients & Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly     allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg     bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg     fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe.     Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast     drip during, and continued after spinal anesthesia.      Patients were monitored for hemodynamic parameters, time of sensory onset and height of     maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and     the frequency of side effects.   "
54103|NCT02577419|"     Breast milk is the reference normative standard for infant feeding. When an infant is     diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to     the presence of long chain triglycerides (LCT) that contribute to persistent chylous     drainage. In its place, the infant is prescribed a therapeutic formula high in medium chain     triglycerides (MCT) as treatment for chylothorax. Families and health care providers are     interested in using breast milk, in a modified fat form, as treatment for chylothorax     instead. This study will assess growth in infants receiving one of two nutrient enriched     modified fat breast milk (MFBM) treatments for chylothorax. If either of the proposed     nutrient enrichment methods support growth, MFBM will become a standard chylothorax treatment     option for infants at SickKids.   "
54104|NCT02577406|"     This is an international, multicenter, open-label, randomized, Phase 3 study comparing the     efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years     or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or     third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.   "
54105|NCT02577393|"     The investigators conducted this phase II study of EGCG therapy protection of the esophagus     from damage induced by radiotherapy. In order to observe the effectiveness of EGCG,     esophageal toxicity was recorded weekly using a grading scale based on symptomatology,     following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain     related to esophagitis was measured using the numerical rating scale (NRS) every week from     EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into     Chinese and guides in Chinese are developed instructing how to use the scales and perform the     assessments.   "
54106|NCT02577380|"     The overarching goal of this study is to pilot an approach to HIV testing and counseling     (HTC) that addresses intimate partner violence. The results of the study will fill an     important gap in the literature and contribute to efforts by Kenyatta National Hospital in     Nairobi, Kenya—and the HIV and sexual and reproductive health field globally—to better     address intimate partner violence in our work.   "
54107|NCT02577367|"     The study aims to describe the changes in Levothyroxine dosage requirements in patients with     hypothyroidism started on enteral feeding, and assess whether giving levothyroxine on empty     stomach affects the mean percentage increase expected in Levothyroxine dosage in these     patients.   "
54108|NCT02577354|"     The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the     treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in     conjunction with medical management.   "
54109|NCT02577341|"     This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in     combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.   "
54110|NCT02577328|"     The assessment of pain management in Internal medicine department.   "
54111|NCT02577315|"     Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets     compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male     and female volunteers under fed conditions   "
54112|NCT02577302|"     As a screening evaluation, all subjects will have a needle placed transcutaneously at the     baseline visit to confirm that the subject feels a pulsation on the foot or toes with or     without flexion of one or more of the toes. This motor nerve test demonstrates that the nerve     is responsive to stimulation as an indicator that the subject is an eligible candidate for     both PTNS and CAN-Stim therapies.      Subjects will be randomized to either CAN-Stim or PTNS after eligibility is determined from     the screening test.   "
54113|NCT02577289|"     Evaluation of bone quantity in open sinus lift technique with space maintaining using     platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline     hydroxyapatite with simultaneous placing of implants.   "
54114|NCT02577276|"     Is a unique tele-rehabilitation service directed at treating upper limb weakness due to     stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the     clinicians providing the care satisfied with the process?   "
54115|NCT02577263|"     The primary objective of this trial is to determine the impact of the FOLFOX regimen on     quality of life and the incidence of chemotherapy induced neurotoxicity.   "
54116|NCT02577250|"     The relationship between depression and trauma is well established. Co-occuring depression     and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower     levels of functioning. Veterans with both depression and PTSD have been shown to be at much     higher risk of suicide than individuals with only one of these disorders. Ketamine has been     shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms.     The purpose of this study is to see whether ketamine, when given as repeated infusions, can     produce quick and sustained improvement in depression and PTSD symptoms for individuals who     have not had their symptoms effectively treated by current treatments.   "
55610|NCT02557737|"     The aims of this study were to compare the injection locations of key spastic muscles on     upper extremity by three different guidance localization methods ( surface anatomy landmark,     ultrasonography, electric stimulation) and the effectiveness.   "
54117|NCT02577237|"     Patients with head and neck cancer and their caregivers face many challenges. These include     learning about cancer and its treatment, coping with symptoms from illness and treatment side     effects, making adjustments to usual activities, and managing the emotional effects of having     a serious illness. This study tests whether different forms of education and support can help     family caregivers feel better prepared. To find out if education about caregiving and     different kinds of support are effective, this study wants to compare approaches.One group     includes caregivers who will receive an education and support program throughout radiation     treatment in addition to usual care by their doctors and nurses. The other group receives an     educational booklet about caregiving in addition to usual care by their doctors and nurses.     The caregiver also completes surveys about his or her emotions, distress, confidence as a     care giver, and quality of life. In addition, the study asks the caregiver questions about     his or her age, race, ethnicity, marital status, employment status, education, annual     household income, and current living arrangements. This pilot study will only be offered at     the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive     Cancer Center Main Campus.   "
54118|NCT02577224|"     Blepharospasm and hemifacial spasm are debilitating conditions which significantly impact on     patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary     relief but the duration of treatment efficacy is variable. The standard model of patient care     defines routine fixed- time based scheduled treatment cycles which may lead to unnecessarily     frequent treatment for some patients and experience of distressing symptoms in others if     symptoms return before the scheduled follow up period. The present study aims to compare a     patient-initiated model of care, where patients determine treatment timing, with the standard     model of care by using a two-arm randomised controlled trial design. It is expected that     patients able to initiate their own treatment will experience less variation in disease     severity and disability over a treatment cycle as they will be empowered to take the     initiative when they feel they need to have treatment. A range of other outcomes will be     assessed including: confidence and satisfaction in the service, depression, anxiety, quality     of life and, illness and treatment beliefs. If the patient-led care model is shown to be     effective in preventing distress and reducing disability in these populations; and is found     to be acceptable to service users, this will have significant implications for service     organisation across the NHS.   "
55842|NCT02554695|"     This protocol addresses: 1) How gene expression changes in bone cells are affected by aging?     2) Is aging associated with decreased signaling between bone cells? 3) How does treatment     with the osteoporosis medication denosumab affect bone cell signaling?   "
54119|NCT02577211|"     The aim of this study is to compare two nutritional regimes in critically ill patients.     Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15     kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA     (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic     diet decreases the incidence of organic failure in these patients.   "
54120|NCT02577198|"     Computerized decision support systems (CDSSs) are information technology-based software that     provide health professionals with actionable, patient-specific recommendations or guidelines     for disease diagnosis, treatment, and management at the point-of-care. CDSSs may be     integrated with patient electronic health records (EHRs) and evidence-based knowledge.   "
54121|NCT02577185|"     The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum     toxin type A compared to that of injected vehicle.   "
54122|NCT02577172|"     The present study examine the effects of an aerobic and strength training program on     cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of the     participants will receive the exercise program and the other half will receive one individual     lifestyle counseling session. The investigators hypothesize that TC patients in the exercise     group will have less reduction in cardiorespiratory fitness during chemotherapy treatment     compared to patients in the control group.   "
54123|NCT02577159|"     The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein     metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus whose     HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will examine     changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C before and     after the 8 weeks administration of dapagliflozin.   "
54124|NCT02577146|"     This is a single institution, prospective study to evaluate the prognostic significance of     renal and bladder ultrasound with ureteral jet assessment and its utility to evaluate the     spontaneous stone passage rate of ureteral stones.   "
54125|NCT02577133|"     Colic is a term for inconsolable crying happened in the first months of life. Its etiology is     multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk     of child abuse as well as economic costs.      There is now enough evidence for the treatment of colic using probiotics, especially     Lactobacillus reuteri.      The investigators study aims to demonstrate the utility for the prevention of colic with L.     reuteri and thereby avoid the problems caused by this pathology.      Objective: Compare the number of events of colic among infants with oral probiotic     Lactobacillus reuteri during the first month of life versus infants with placebo      Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age,     breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28     days. The investigators trial will be performed at Naval Hospital in Mexico City.   "
54126|NCT02577120|"     This prospective pilot study is to enroll patients with clinically-defined infected wounds.     Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and     will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound patients     will be recruited for this study in Phase A. Based on the expectation that 89% of these     wounds will heal within 16 weeks of enrollment, 234 of these patients will continue with the     study for Phase B.   "
54141|NCT02576925|"     The transient diplopias (TD) is defined by a short diplopia. Their etiology may be     ophthalmological, neurological non-ischemic or of ischemic origin.      The difficulty is to recognize an ischemic mechanism which imposes emergency cares.      A clinical score could help the clinician to recognize the etiology of the TD .   "
57645|NCT02531009|"     The primary objective of the study is to assess the change in systemic sclerosis     (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants     with SSc.   "
54127|NCT02577107|"     This prospective, randomized, open label study will enroll patients with neovascular AMD who     are naïve to anti-VEGF therapy or have not received intravitreal anti-VEGF therapy for the     previous 3 months. Patients will be randomized in two treatment arms for 3 months:        -  Study arm 1: Three monthly injections of 0.5mg Ranibizumab        -  Study arm 2: Three monthly injections of 0.5mg Conbercept Blood sample (plasma/serum)          will be collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28,          following doses 1 and 3 for PK and systemic VEGF analysis. The lab staff will be blinded          for treatment allocation.      Plasma VEGF concentration will be measured by a blinded laboratory using Quantikine® ELISA     kits. Serum ranibizumab and conbercept concentration will be determined using validated ELISA     assay.      The study will be divided into 2 stages: the 1st initial feasibility stage with 6 patients     per arm (12 patients in total) to verify SD for sample size justification and 2nd stage to     confirm the findings with justified sample size.   "
54128|NCT02577094|"     Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab     radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen FB2A2     before allogeneic stem cell transplantation.   "
54129|NCT02577081|"     Neck of femur fractures are common in the elderly and are the source of significant morbidity     and mortality. This study is based on a new technique developed in Ben Gurion University,     with which investigators are able to asses the structural 3 dimensional strength of a bone by     applying a unique simulation on a CAT scan of the bone. The purpose of this study is to     evaluate the risk of a contralateral neck of femur fracture after the first neck of femur     fracture and to estimate the potential fracture characteristics.   "
54130|NCT02577068|"     Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior     neck pain because of neck extension position during the surgery. However, there has been     little attention of posterior neck pain. Nefopam and Propacetamol have different     pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The     aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute     wound pain, posterior neck pain and chronic pain after thyroidectomy.   "
54131|NCT02577055|"     Purpose of this study:      To establish the equivalence of poly-myomectomy versus Uterine Artery Embolization, in women     with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.   "
54220|NCT02575885|"     This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco     electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various     types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from     conventional cigarettes (the participant's own brand) may help provide information about the     use of nicotine-containing products that may help inform/reform current tobacco policy,     practice, and harm reduction approaches.   "
55843|NCT02554682|"     The primary objective is to conduct a pilot study to determine the efficacy of evidence-based     interventions delivered in primary care clinic settings on parent-teen health communication.   "
54132|NCT02577042|"     Physicians in charge of HIV-infected patients are increasingly being faced to previously     unrecognized comorbid conditions such as atherosclerosis and cardiovascular events, loss of     renal function, osteopenia/osteoporosis and bone fractures or non-AIDS-defining cancers     (1-4). The incidence of these conditions seems to be higher than in the general population     but there are controversial data about if these diseases appear at a younger age in     HIV-infected patients.      The investigators propose a strategy for treatment of elderly HIV-infected patients with a     double impact on systemic inflammation and age-related co-morbidities by switching the     protease inhibitors by raltegravir, a integrase inhibitor with a neutral effect on lipid and     bone metabolism, and adding an statin because of their anti-inflammatory effect. For safety     reasons, only patients with maintained viral suppression (documented indetectable viral load     for 1 year or more), and no history of virological failure to integrase inhibitors or     suspected or documented resistance mutations to the integrase or retrotranscriptase will be     candidates for the study.      Interleukin -6 and D-dimer are biomarkers that most strongly predict mortality in treated HIV     infection and sCD14, sCD163 are soluble markers of monocyte activation that reflect a key     source of inflammation and coagulation in HIV infection and predict mortality (26,27). For     that reasons, these markers were chosen to determine changes on them after the introduction     of the statin and the change of antiretrovirals   "
54133|NCT02577029|"     Patients with chronic Hepatitis B Virus (HBV) infection will receive either ARC-520 alone or     ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF)     and/or pegylated interferon alpha 2a (PEG IFN) therapy, and be evaluated for safety and     efficacy.   "
54134|NCT02577016|"     This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese     participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on     ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the     addition of sitagliptin once daily compared with placebo provides greater reduction in     hemoglobin A1C (HbA1C) as assessed by change from baseline (Week 0) to Week 24.   "
54135|NCT02577003|"     This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily     in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic     control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is     that the addition of ipragliflozin compared with placebo provides greater reduction in     hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.   "
54136|NCT02576990|"     In this study, participants with relapsed or refractory primary mediastinal large B-cell     lymphoma (rrPMBCL) or relapsed or refractory Richter Syndrome (rrRS) will receive     pembrolizumab (MK-3475). The efficacy of pembrolizumab in the treatment of rrPMBCL and rrRS     will be evaluated.   "
54137|NCT02576977|"     The purpose of this study is to compare the efficacy of pomalidomide and low dose     dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone     without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with     refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2     lines of prior treatment.   "
54142|NCT02576912|"     The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the     acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will     be tested by pretreating healthy individuals with PREG and then assessing their responses to     THC.   "
54143|NCT02576899|"     Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and     have substantial difficulties with quitting tobacco. Only 23% of individuals with PTSD quit     smoking compared to 50% of the general population. As a result, Veterans with PTSD are at     high risk of developing severe health problems and poor physical functioning. Fifty percent     of these long-term smokers will die of a smoking-related cause and on average, will lose 25     years of their life compared to non-smokers. Despite the significant morbidity and mortality     associated with smoking, no smoking cessation treatments exist that intensively target PTSD     symptoms as an obstacle to quit smoking, although this is a significant barrier to quitting     for many Veterans. In addition, no smoking cessation treatments have a large emphasis on     improving the functioning of Veterans with PTSD and tobacco dependence, although both PTSD     and tobacco use negatively affect functioning across physical, mental health, and social     domains.      The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans     with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking     cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically     targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to     difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during     quit attempts. ACT-PT includes structured intervention components that guide Veterans to     replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping     strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in     work, expanding social networks, engaging in physical exercise) that are consistent with     Veterans' values. This emphasis on substantially improving health-related quality of life and     functioning across several areas makes ACT-PT particularly innovative and different from     existing treatments. However, research is needed on the relative feasibility, acceptability,     and efficacy of ACT-PT compared to standard smoking cessation treatments.      The proposed SPiRE (I21) will involve a randomized clinical trial study of 50 Veteran smokers     with PTSD and tobacco dependence randomized to one of two different types of psychosocial     treatment 10 individual sessions of ACT-PT (n= 25) versus 10 individual sessions of the     American Lung Association's Freedom From Smoking Program [FFS] (n=25) with all participants     receiving 12 weeks of the nicotine patch. This study has two primary aims: 1) evaluate the     relative feasibility and acceptability of the two interventions (including ease of     recruitment, randomization proportion, staff and Veteran acceptance of the treatment,     retention rates, treatment adherence, fidelity, ease of the assessment process), and 2)     evaluate the preliminary efficacy of ACT-PT vs. FFS with the primary outcomes of tobacco use,     PTSD symptoms, health-related quality of life, and functional impairment.   "
56336|NCT02548234|"     The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on     movement strategies of the affected upper extremity and functional outcome in chronic stroke     patients.   "
54144|NCT02576886|"     Participants are being asked to participate in this research study because the participant's     doctor has ordered a myocardial perfusion SPECT (Single-Photon Emission Computed Tomography)     scan to look at the blood flow in the participants heart.      Myocardial perfusion imaging is a proven test that looks at the blood flow to the     participant's heart after the injection of a radioactive tracer. The standard test requires     two injections of the radioactive tracer and takes images of the participant's heart at rest     and after a stress test. It has been proposed that in some cases, patients could have images     done only after the stress portion of the test and, if normal, the rest images would not need     to be done. In this case, only one injection of the radioactive tracer would be needed. It     has further been proposed that adding another stress image made with the participant lying on     their stomach, will increase the confidence of the reporting doctor in reporting stress     images.      The purpose of this study is to find out if the extra information added from the image with     the participant on their stomach helps the doctor when reporting the test results.   "
54145|NCT02576873|"     A retrospective cohort study was conducted in 66 end-stage renal disease patients who     underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial Hospital     between 2001-2013 to determine the survival rate as well as other long-term outcome.   "
54146|NCT02576860|"     This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel     compared to vehicle gel in subjects with severe papulopustular rosacea.   "
54147|NCT02576847|"     This study evaluates the long-term safety of once-daily application of Omiganan topical gel     in subjects with severe papulopustular rosacea.   "
54148|NCT02576834|"     The literature is characterized by a dearth of information on interventions for homeless     youth, and no suicide prevention intervention has been tested with these youth. Such focus is     critical as suicide is the leading cause of death among homeless youth. Therefore, this study     seeks to address this gap in the research literature with the goal to identify an effective     strategy to intervene in suicide ideation in this population.   "
54149|NCT02576821|"     Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease     (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as     well as the level of hippocampal atrophy in bvFTD may be of similar severity to that observed     in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with post mortem     diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can also cause     impairment of episodic memory mimicking AD, without subcortical cognitive profile. Because     these diseases involve distinct pathophysiological processes, they require different specific     care and treatment. In consequence, it is very important to improve our knowledge about HS in     order to identify its mechanism and improve the diagnosis.   "
54150|NCT02576808|"     Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients     compared with Loratadine.The double blind randomized controlled trial study was approved by     the Human Research Ethics Committee of Thammasat University NO.1.   "
54151|NCT02576795|"     This study is being conducted by Biomarin Pharmaceutical Inc. as an open label, dose     escalation study in order to determine the safety and efficacy of BMN 270 (an     Adenovirus-Associated Virus based gene therapy vector in participants with severe Haemophilia     A.   "
54161|NCT02576665|"     This is a multicenter, open label, single arm study of Toca 511 and Toca FC. Based on their     cancer diagnosis (brain metastases from non small cell lung cancer or breast cancer;     colorectal cancer with liver metastases; metastatic renal cell carcinoma; locally advanced or     recurrent melanoma; locally advanced or metastatic pancreatic cancer or breast cancer [ie,     other than resectable brain metastases]) subjects will receive Toca 511 either intravenously     (IV) or intralesionally (IL). Up to 6 subjects will be enrolled for each disease group. In     all but the melanoma group, Toca 511 will be administered by IV injection for 3 consecutive     days (14 mL per day); in the melanoma group, at least 3 subjects may receive Toca 511 by IV     injection (same dosing regimen as the other 3 groups), and at least 3 subjects will receive     Toca 511 by IL injection (approximately 0.1 mL to 4 mL for 5 consecutive days). Based on the     disease group, subjects will have either multiple core biopsies or a resection of a     metastatic lesion (primary for subjects with renal cell carcinoma undergoing debulking     nephrectomy), approximately 14 to 28 days after Toca 511 administration. A portion of the     resected or biopsied tumor sample will be evaluated for the presence of Toca 511 vector     sequences and markers for disease characteristics. After recovery from the biopsy or surgery     (approximately 4-6 weeks from Toca 511 treatment start), subjects will begin the first cycle     of oral Toca FC (ie, a 7 day course of 220 mg/kg/day; thereafter, cycles of 7-day courses of     Toca FC will be repeated approximately every 6 weeks). Toca FC may be continued alone or in     conjunction with standard therapy (other investigational treatments prohibited). One or more     disease groups may be expanded to allow replacement of subjects or to provide a better     assessment of efficacy. Subjects will be followed for safety for up to 15 years as required     by regulatory authorities. In addition, subjects will be followed for efficacy (objective     response and survival).   "
54162|NCT02576652|"     Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total     Hip Replacement   "
58767|NCT02516345|"     This study aims to test whether incentives can motivate children to promote increased     physical activity of a working parent while also increasing their own activity levels.   "
54152|NCT02576782|"     In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8     hours. Increasing the duration of local anaesthetic action is often desirable because it     prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong     regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing     vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil     were added to local anaesthetics, but the results are either inconclusive or associated with     side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there     is no evidence suggesting any neuritis when steroids are used in low concentration in     peripheral nerve blocks.      Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural     injection of steroids is reported to influence postoperative analgesia. They relieve pain by     reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing     ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5%     levobupivacaine in interscalene brachial plexus block showed improvement of postoperative     analgesia for arthroscopic shoulder operation without any specific complications.      The objective of this study is to compare the effects of combining of dexamethasone and     bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients     undergoing lower limb vascular surgeries. The effects will be studied in terms of:        -  Onset of sensory blockade and motor blockade        -  Duration of analgesia / first request for analgesic        -  Duration of motor blockade   "
54153|NCT02576769|"     Basal cell carcinoma (BCC) is the most frequent neoplasia worldwide. There are more than 30     histopathologic subtypes, however the nodular subtype is the most common. Pigmented varieties     are common in darker skin types, therefore in our country. Previous studies have shown an     increase number and size of melanocytes. Melanogenesis were increased at the expense of     hyperfunctioning melanocytes as well. The aim of the study was to describe the     characteristics of melanocytes in pigmented and non-pigmented variants of basal cell     carcinoma.   "
54154|NCT02576756|"     The investigator wants to investigate if there is an increased risk of postoperative     pulmonary problems in patients who have had an intubation where there was need for more than     a laryngoscope.   "
54155|NCT02576743|"     This study aims at investigating the blood hemodynamics with high spatiotemporal resolution     in patients with brain aneurysms and AVMs as well as in healthy controls. Parameters such as     peak blood velocity, wall shear stress and other derived parameters will be obtained from 4D     flow MRI data acquired at ultra-high field strength (7 Tesla).   "
54156|NCT02576730|"     To include patient after traumatic (calcaneal) fractures for this study. They can be included     to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the     movement laboratory of the MUMC. Markers will be detached with dubble sided tape on     anatomical points. After that gait will be recorded with infra-red camera's and an animation     model will be formed. With this model further analysis can be made to range of motion between     different segement of the foot. These results will be compared with patient with an     arthrodesis, healthy subjects, futher questionnaires, physical examination and radiographic     findings will be correlated.   "
54158|NCT02576704|"     Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events     for patients with known or suspected coronary artery disease. If the test is normal, or if     the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the     patient is considered at low risk and should be managed with optimal medical treatment only.      Recently, new gamma cameras using semi-conductor detectors have been developed. Their     diagnostic performances have been demonstrated and confronted with various anatomical and     functional reference techniques, such as coronary angiography and FFR. The prognostic value     of a normal SPECT MPI has not been specifically assessed yet.      Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of     coronary artery disease (CAD). Preliminary data suggest that myocardial perfusion     heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on     conventional MP-SPECT, but its additive and independent prognostic value over the presence of     myocardial ischemia remain unknown.      Accordingly, the purpose of this study is :        -  To assess the prognostic value of a normal myocardial perfusion stress imaging using a          semiconductor gamma camera with a dual isotope high speed protocol,        -  To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new          automatized image processing method, in normal SPECT MPIs.      The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive     of cardiovascular events in patients referred to the Nuclear Cardiology Department for     routine evaluation of known or suspected CAD.   "
54159|NCT02576691|"     The purpose of this study is To assess percutaneous coronary intervention 's effect on short-     and long- term outcomes, and complication incidence in resuscitated victims of cardiac arrest     after acute myocardial infarction   "
54160|NCT02576678|"     This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque     psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK     of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of     apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area     Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global     Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a     total of 107 weeks which includes screening, treatment (including the PK portion of the study     and the extension treatment period), two short-term follow-up periods and a long-term     follow-up period.   "
54163|NCT02576639|"     The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for     Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in     subsequent efficacy studies.   "
54176|NCT02576470|"     The overall goal is to exploit motor learning principles and adjuvant techniques in a novel     way to enhance dysphagia rehabilitation. The proposed study will investigate the effects of     three forms of biofeedback on training and determine whether adjuvant therapeutic techniques     such as non-invasive neural stimulation and reward augment training outcomes has an effect of     dysphagia rehabilitation. Outcomes from this research study may change the paradigm for     treating swallowing and other internal functions such as speech and voice disorders.   "
54177|NCT02576457|"     The purpose of this study is to determine whether BMS-936559 is safe and has the desired     pharmacologic activity in patients who have severe sepsis.   "
54164|NCT02576626|"     Rationale:      Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered     by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and     wet nebulizers. Wet nebulization is available for short-acting bronchodilators only, is     cumbersome, and, importantly, has never been scientifically been proven to be more     efficacious than delivery by the other two methods. Yet many patients are happy with wet     nebulization and in many clinics this administration method prevails. The investigators     believe that combined long-acting bronchodilators, are more efficacious than combined short     acting bronchodilators per nebulizers.      Objective:      To test the hypothesis that: The combination of the two long-acting bronchodilators     indacaterol and glycopyrronium by dry powder inhalation confers a superior improvement     compared to nebulisation with ipratropium/salbutamol, when administered as single dose in     patients with stable state chronic obstructive pulmonary disease (COPD).      Study design: Investigator initiated, randomised, active controlled, cross-over double-blind     (and therefore double-dummy), study comparing the effects of single dose     indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol     nebulisation in patients with COPD in stable state Study population: Patients visiting the     outpatient clinics or from general practitioner (GP) practices with COPD GOLD stage A-D, and     (FEV1) post-bronchodilator FEV1/ forced vital capacity (FVC) < 70%; post-br FEV1 < 80%pred.     Intervention The investigators will compare the effects of single dose     indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol     nebulisation in patients with COPD in stable state      Main study parameters/endpoints:      Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium,     compared to nebulisation with ipratropium/salbutamol      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      This study has no specific benefits for the participating patients. The study also has no     major risks. Minor risks for participants after a single dosis can be throat irritation,     cough, headache and dizziness, sinus tachycardia. The combination of treatments with     β2-agonist bronchodilators and anticholinergic bronchodilators have been used in daily     practice for many years in many countries and they are often prescribed both in COPD. Both     indacaterol/glycopyrronium and ipratropium/salbutamol are approved for COPD treatment in the     Netherlands   "
54165|NCT02576613|"     A randomized controlled, prospective, two-armed, mono-centric, assessor-blinded clinical     trial will serve to generate preliminary data on the efficacy and safety of modified     psychodynamic therapy (MPP-S) in stabilized patients after the first or subsequent episodes     of schizophrenia or schizoaffective disorder.   "
54166|NCT02576600|"     The aim of this prospective randomized study was to evaluate the impact of peroperative     pupillometry monitoring on per and post-operative opioid consumption in major gynecological     surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the     intervention group, peroperative remifentanil target was guided by pupillometry. In the other     group, remifentanil was administered according to standard practice.   "
54221|NCT02575872|"     This randomized clinical trial studies a physical activity behavioral intervention in obese     endometrial cancer survivors. Learning about physical activity behavior while participating     in a fitness class may help increase physical activity and improve the quality of life of     obese endometrial cancer survivors.   "
56114|NCT02551133|"     This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy     operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half     will receive 0.2 mg/kg dexamethasone.   "
54167|NCT02576587|"     The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study.      The study involves a case control design to investigate the extent to which there is an     independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial     fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and     controls as those without AF. In order to rigorously address important biologic confounding     influences, the cases and controls will be individually matched based upon age, gender, race,     and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI>=15)     will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical     Research Unit (CRU) for collection of the same measures collected at the baseline exam to     observe for any significant changes with the purpose of collecting effect size data to inform     future clinical trials.      The total duration of the study is 4 years. The duration for any individual participant is up     to from one to 13 weeks months, including a 3-month treatment period for those with moderate     to severe SDB, i.e. AHI>15.   "
54168|NCT02576574|"     The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS)     or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an     Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with     Programmed death ligand 1+ (PD-L1+) tumors   "
54169|NCT02576561|"     The purpose of this research study is to test the safety and effectiveness of the     investigational study vaccine, called TVGV-1. The study will test the vaccine in women with     high grade HPV cervical infection.   "
54170|NCT02576548|"     This research study is designed to evaluate an experimental drug, MEDI4276, in treating     breast and stomach (gastric) cancer.   "
54171|NCT02576535|"     Stereotactic radiosurgery is a well established treatment option for arteriovenous     malformations (AVMs). The potential complications related to radiosurgery are well documented     and are predominately related to radiation effects to the surrounding brain parenchyma. These     risks increase with larger lesions, requiring a concommitant reduction in the amount of     radiation that can be delivered. This reduction in radiation dose decreases the efficacy of     treatment. The broad, long-term objectives of this proposal are 1) to determine the role of     fractionated stereotactic radiosurgery in the treatment of large (>10cc) AVMs; 2) to evaluate     the complication rates related to fractionating these doses compared to conventional     stereotactic treatment 3) to evaluate the success rate of treating large AVMs with this     protocol.   "
54172|NCT02576522|"     Investigators designed a study of a multimodality approach: surgery followed by     hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for     patients with single, large brain metastases from solid primary tumor   "
54173|NCT02576509|"     The purpose of this study is to determine if nivolumab or sorafenib is more effective in the     treatment of Advanced Hepatocellular Carcinoma.      NOTE: Global recruitment is complete but enrollment is ongoing for the China sub-study.      The Primary Completion Date for ORR will be reached July 2017. The Completion Date for all     Primary Outcome Measures is expected in October 2018.   "
54174|NCT02576496|"     This study evaluates the efficacy, safety and pharmacokinetics of EDO-S101 in patients with     relapsed/refractory hematologic malignancies. All patients will receive EDO-S101.   "
54175|NCT02576483|"     The principle investigator is evaluating self-reported quality of vision and quality of life     in physicians undergoing LASIK and PRK surgery.   "
54178|NCT02576444|"     The primary objective of this phase II trial is to determine tumor overall response rate     (ORR) in molecularly selected patients with measurable disease as assessed by the Response     Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment     across tumor types in each arm of the study.   "
54179|NCT02576431|"     Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a     fusion of NTRK1, NTRK2 or NTRK3.   "
54181|NCT02576405|"     It has been established that patients with psychiatric disorders tend to do worse in a     surgical setting. Some types of surgery with greater impact than others, including orthopedic     surgery. In our research group the investigators have shown this to be the case for hip and     knee replacements within the mentioned patient category. However, the role of psychiatric     disorder and use of different psychopharmacological drugs in relation to perioperative     morbidity and mortality have not been thoroughly examined. The objective of this study is to     shed light on the issue.      Recent studies have shown that different types of psychiatric disorder influence surgical     outcome differently. This emphasizes the need for specific knowledge regarding psychiatric     diagnoses preoperatively. In this study around 2000 patients with or without psychiatric     disorder of any kind will be studied preoperatively, which according to our previous study     will include more than 200 patients receiving psychopharmacological treatment. The specifics     that characterize every patient's psychiatric trades will be included in a validated     questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been     chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen.     Preoperative information regarding their mental condition and medicine will be linked to     surgical outcome in order to identify potential hazards in the perioperative period.   "
54182|NCT02576392|"     This randomized trial evaluates an intervention to minimize use of opioids following total     hip and total knee replacement. Half the participants will receive an intervention (mailed     educational materials, followed by a pharmacist call), and half will receive usual care.   "
54183|NCT02576379|"     Stroke is a leading cause of death and disability, and 15 million people suffer a stroke each     year; one-third die and one-third are left permanently disabled. Because the risk of stroke     increases with age, it has been considered a disease of the elderly, but stroke also occurs     in middle-aged people.      Thrombolysis with tissue plasminogen activator (tPA) is the preferred choice of reperfusion     therapy of ischemic stroke if performed within 4.5 hours from symptom onset. Time to     thrombolysis is associated with improved outcome: the sooner the treatment, the less risk of     serious - and possibly permanent - damage to the brain. Unfortunately, only a small fraction     of stroke patients make it to thrombolysis within the 4.5-hour; one explanation may be system     delays including prolonged transportation.      In May 2010, the first physician-staffed Helicopter Emergency Medical Service (HEMS) was     implemented in the Eastern part of Denmark. An observational study evaluating the short-term     effects of HEMS implementation compared patients transported by conventional ground ambulance     (Ground Emergency Medical Service (GEMS)) to patients transported by HEMS. Patients     transported by helicopter had increased time to specialized care. However, both 30-day and     1-year mortality was slightly lower in patients transported by HEMS, although not     significant, as was the degree of disability at three months measured by the modified Rankin     Scale (mRS).   "
54184|NCT02576366|"     Single center, open label crossover study with 2 treatment phases in healthy volunteers.      The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus,     voriconazole and rifampin will be assessed.   "
54185|NCT02576353|"     The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic     relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The     secondary objective is to determine the safety and tolerability of fentanyl sublingual spray     in opioid naive subjects.   "
54186|NCT02576340|"     Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase     the tolerability and compliance of the patient, sedation is applied. There are many studies     showing that sedation increases the patient compliance and the tolerability. However,     spasmolytic use in GE has not been evaluated yet.   "
54187|NCT02576327|"     The purpose of this study is to evaluate the efficacy and safety of additional aprepitant to     standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.   "
54188|NCT02576314|"     The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir     containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3     infection.   "
54189|NCT02576301|"     Phase 1 will investigate maximum tolerated dose of OXi4503 as a single agent and in     combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or     MDS.      Phase 2 will investigate overall response rate of OXi4503 in combination with     intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior hypomethylating     agent (Arm A) and 2) subjects with relapsed and refractory AML after treatment failure of up     to 1 prior chemotherapy regimen (Arm B).   "
54190|NCT02576288|"     Abdominal obesity is a major risk factor for heart attack, stroke, peripheral vascular     disease, dementia, cancer and Type 2 diabetes. The central hypothesis for this proposal is     that pro-atherogenic mediators emanate from inflammation in deep subcutaneous adipose tissue     (dSAT) that are released into the systemic circulation and damage the arterial vasculature.     The investigators postulate that inflammation of dSAT, when quantified by macrophage     phenotyping/enumeration will be a) closely linked with systemic levels of pro-atherogenic     mediators and b) tightly associated with endothelial dysfunction and loss of central arterial     elasticity, which are highly predictive of future cardiovascular disease (CVD) complications.     These relationships provide the basis for macrophage-targeted therapy to reduce     obesity-related inflammation and impaired arterial vasoreactivity. The investigators will     evaluate a novel approach using a dipeptidyl peptidase 4 inhibitor (DPP4i) sitagliptin, which     blocks signal transduction for monocyte/macrophage activation. Thus, in abdominally obese,     18-40 years-old adults without clinical CVD, the show study is expected to show that     sitagliptin versus placebo will:        1. significantly improve early measures of arterial damage (brachial artery endothelial          dysfunction and reduced carotid elasticity).        2. significantly attenuate inflammation in dSAT and local production of pro-inflammatory          mediators in adipose tissue, which will be associated with decreases in systemic          pro-atherogenic mediators that contribute to atherogenesis.      Since many obese persons fail to sustain weight loss by lifestyle interventions including     diet and exercise, an important public health goal is to identify relatively safe alternative     strategies that can be used pre-emptively in asymptomatic obese persons when arterial     dysfunction and damage is still reversible before atherosclerosis progresses to serious CVD     events.   "
54191|NCT02576275|"     This study will evaluate the efficacy and safety of duvelisib in combination with     bendamustine and rituximab (DBR) vs placebo in combination with bendamustine and rituximab     (PBR) in subjects with previously-treated indolent non-Hodgkin lymphoma (iNHL).   "
54192|NCT02576262|"     Papanicolaou (Pap) triage, with high specificity, has been recommended for primary Human     papillomavirus (HPV) testing but is flawed by poor sensitivity and cytologist dependence. the     investigators evaluated the potential role of HPV Integration detection in cervical     exfoliated cells in HPV-positive women from a clinic-based population.   "
54193|NCT02576249|"     Corticosteroid injections are commonly used for the symptomatic treatment of knee     osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid     and local anesthetic, with the rationale of providing longer duration pain relief with the     corticosteroid and immediate, though short duration relief with the anesthetic. However,     multiple in vitro and animal studies have shown that local anesthetic may be harmful to     chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many     clinicians believe incorporating the anesthetic is important because it can provide immediate     pain relief and facilitate patient confidence in the treatment program. However, there is no     published data to validate this reasoning. Therefore, the anesthetic has unknown clinical     benefit and may have adverse effects on articular cartilage. In light of this, the     investigators question the routine use of anesthetics in joint injections. The purpose of     this study is to compare the effects of knee joint injections using: 1) corticosteroid with     local anesthetic versus 2) corticosteroid with normal saline.   "
54222|NCT02575859|"     The prognosis of peritoneal metastases from colorectal cancer has recently improved with     cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Although     outcomes are further improved when early stage peritoneal metastases are treated, adjuvant     HIPEC has not yet been thoroughly addressed. This prospective pilot study assessed     feasibility, safety and efficacy of HIPEC performed simultaneously with primary curative     surgery in colorectal cancer patients with primary tumor-related risk-factors for the     development of metachronous peritoneal metastases.   "
54194|NCT02576236|"     The H pylori infection remains a public health problem. The eradication rate with the first     line triple therapy (PPI-amoxicillin-clarithromycin) is insufficient (estimated at 70%) due     to the frequency of resistance to clarithromycin, which reaches 21% in France. Until     now,European and French consensus recomended tofavor sequential therapy (5 days     PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole) or quadruple bismuth therapy (     10 days PPI-tetracyclin,-metronidazole- bismuth). Studies in countries with low prevalence of     clarithromycin resistance reported eradication rate of 85% with sequential therapy and     reported a low impact of clarithromycin resistance on the effectiveness of this treatment.     However, recent studies suggest a greater impact of clarithromycin resistance. Recent     meta-analysis shows that empiric sequential therapy is less efficacious than concomitant     quadruple therapy. Therefore, recent Maastricht V / Florence meeting October 7-8 2015)     recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first     line in order to reach an eradication rate >90%.      In a multicenter randomized clinical trial (HELICOSTIC 2010-2011 AO ICST 2009), we compared a     triple therapy guided by the results of a PCR test that detects resistance to clarithromycin     and levofloxacin (HelicoDR ®) to empirical triple therapy (PPI-amoxicillin-clarithromycin).     1384 patients and among them 526 infected patients were enrolled in 10 centers. The results     in 415 patients were 73.1% for the empirical treatment versus 85.5% (p <0.001) for the     treatment guided by PCR HelicoDR®. This study also demonstrated the limits of the test     HelicoDR®: onerous, possibility of contamination, little practical contribution of the     determination of resistance to quinolones.      Moreover, it has been shown that triple therapy efficiency could be optimized by increasing     duration up to 14 days and increasing dose of PPI to 40mg b.d;.and eradications rates > 90%     were reported with susceptible to clarithromycin strains.      Adverse events are less common with optimized triple therapy than with concomitant quadruple     therapy.      The main objective is to compare the efficacy of optimized triple therapy guided by the     results of a PCR test (eradication rates 90% hypothesized) with quadruple concomitant therapy     (eradication rate 90% hypothesized).      The secondary objective is to determine side effects of optimized guided triple therapy as     well as the quadruple concomitant therapy in France.   "
54195|NCT02576223|"     The purpose of this randomized study is to examine the effect of a selective suprascapular     nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects     will receive a active nerve block with Ropivacain. Half of the subjects will receive a     placebo nerve block with saline.   "
54196|NCT02576197|"     This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional     treatment of mild to moderate plaque psoriasis. Half of the patients will receive the     probiotic per os, while the other half will receive a placebo; all patients will continue     with their regular psoriasis treatment.   "
54197|NCT02576184|"     This study aim to assess long-term results of an incisional hernia-prophylactic mesh     placement during stoma reversal after total mesorectal excision (TME) for rectal cancer   "
54198|NCT02576171|"     The primary objectives of this study is to test the feasibility and efficacy of group-therapy     supported internet-delivered CBT for adolescents (13 - 17 years) with social anxiety     disorder. Investigators will conduct an open trial with N = 30 participants. Participants     will be assessed at baseline, immediately after treatment and at a 6-month follow-up.   "
54199|NCT02576158|"     The primary objective is to determine the sensitivity and specificity of the HPV     Integration-based cervical screening for detection of high-grade cervical intraepithelial     neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be     confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.   "
54200|NCT02576145|"     This study will assess whether daclizumab impairs the ability of children receiving a kidney     transplant to elicit a primary immune response. The anticipated time on study treatment is 1     day, and the target sample size is 82 individuals.   "
54201|NCT02576132|"     This study was part of a quality improvement project at the Department of Anesthesiology and     Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.      Being in pain is reported to be one of the most important stressors in critically ill     patients and worsens outcome. The evaluation of pain using validated scores in patients who     are able to self-report significantly improves the quality of analgesic therapy and health     related outcomes in intensive care patients.      However, behavioral pain score that are used in sedated or delirious patients, often     underestimate the severity of pain.      The primary aim of this study is to investigate if measurement of the pupillary light reflex     Amplitude correlates with the results of pain assessment using validated pain scores in     critically ill patients.   "
54202|NCT02576119|"     The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT     interval corrected with Fridericia's method (QTcF) in healthy subjects.   "
54203|NCT02576106|"     The primary objective of this monocentric and feasibility study is to review the efficacy of     cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with     lumpectomy indication.      The efficacy is defined by the rate of success of cryotherapy procedures. For each one of     those evaluated process, an success will be defined on the tumor sample of lumpectomy by the     absence of viable tumour cells.      On the basis of our expertise, it seems interesting to propose this experimental procedure to     patients as described above.   "
54236|NCT02575677|"     Oxycodone is used to treat early labour pain instead of meperidine. However, the efficacy and     effects of oxycodone to the newborn has not been studied. In the present study, patient who     has received oxycodone is asked about pain relief and after labour single venous blood sample     from the parturient and umbilical cord are taken for the analysis of oxycodone.   "
54204|NCT02576093|"     Purpose of the study is the local tolerability and systemic safety of a novel k-opioid     receptor agonist proven to inhibit inflammation and pruritus in preclinical model of     dermatitis.      Three concentrations of WOL071-007 and placebo will be applied to patients with AD in a     first-in-human, single-center, combined single/multiple ascending dose (SAD/MAD),     double-blind, placebo-controlled, half-side comparison (MAD part only) study. The IMP will be     applied occlusively to lesional or non-lesional skin. In the SAD part 24 subjects will     receive the IMP for 2 days. In the MAD part, 30 hospitalized subjects will receive the IMP     for 6 days. Study objectives are the safety and tolerability as well as (MAD part only) the     pharmacokinetics and efficacy of WOL071-007.   "
54205|NCT02576080|"     Following the ACOSOG Z9001trial, imatinib received market authorization in Europe for     patients with GIST at significant risk of relapse in the adjuvant setting, according to the     classifications of Miettinen and Joensuu. Thereafter, the SSG XVIII / AI trial proved the     need to revise the recommendations of the European Society for Medical Oncology regarding the     optimal duration of treatment, which is currently three years. Patients at low risk of     recurrence should not receive adjuvant treatment with imatinib and recommendations cannot be     made from the literature data as to the indication of adjuvant treatment for patients with an     intermediate risk of relapse. The provision of prognostic molecular markers in this group of     so-called intermediate-risk subjects would facilitate the identification of responders to     imatinib and avoid overtreating some patients and undertreating others who would benefit from     Imatinib. Recently, Lagarde et al. have shown that the Genomic Index (GI = A ² / C, where A     is the total number of alterations gains or losses and C is the number of chromosomes     involved in these alterations in Comparative Genomic Hybridization array(CGH array)) could     have prognostic value in GIST, particularly in intermediate risk GISTs. More recent work by     the same author in 100 cases of GISTs with intermediate prognosis according to the     classification of Miettinem identified two prognostic groups based on GI. The rate of     metastatic relapse at 2 years was 30.6% in the group with GI greater than 10 versus 5.4% in     the group with GI less than 10 (manuscript under preparation). Thus, it is legitimate to set     up a randomized trial to study the effectiveness of adjuvant treatment with imatinib in the     GIST population at intermediate risk of relapse and with a high GI. This study is a     prospective randomized clinical trial: a phase III, open-label, 2 parallel groups,     multicenter study. The primary objective of this study is to assess the efficacy of adjuvant     Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk     gastrointestinal stromal tumor presenting a high Genomic Grade Index. The second objectives     of this study are to compare the two therapeutic approaches in terms of metastasis-free     survival at 1 year, 2 years and 3 years, overall survival, clinical and biological tolerance,     safety and Quality of life of patients and caregivers. The eligible subjects must meet all of     the following criteria : subject with a gastrointestinal stromal tumor, intermediary risk     from the Armed Forces Institute of Pathology classification [Miettenen 2006], subject with     Genomic Grade Index higher than 10 determined by CGH array, subject with surgery for primary     tumor performed from 2 weeks to 2 months before starting adjuvant Imatinib mesylate, subject     with no evidence of residual macroscopic disease after surgery and with a medical decision to     prescribe imatinib. Subjects meeting any of the following criteria must not be enrolled :     subject who have experienced spontaneous tumor rupture before surgery, subject whose tumor     has a PDGFRA D842V mutation evidenced by sequencing from tumor Block and subject whose     mutational status meets the wild phenotype definition as evidenced by sequencing from tumor     Block.      The Standard Group will receive adjuvant imatinib at a dose of 400 mg per day for a period of     3 years. Patients will be assessed for metastases every three months for three years with     thoraco-abdominal and pelvic CT scan. The Experimental Group will receive the same     thoraco-abdominal and pelvic CT scan. The estimated proportion of subjects relapsing at 2     years will be 30% in the experimental group and 2.5% in the standard group: alpha risk, 5%,     power 80%. A total of 80 subjects (40 in each arm) will be included. This is a trial     combining two learned societies that already are taking part in many clinical trials in     France (French Sarcoma Group and French Digestive Cancer Federation). The expected benefits     for patients are : not treat subjects for whom this treatment would offer too little benefit     weighed against the disadvantages and treat subjects in whom this treatment would provide a     real benefit and reduce the cost of treatment in patients who would not benefit from being     treated by imatinib. The originality of this study is that it will include molecular data in     the therapeutic decision and demonstrate the concept of individualized treatment in this     patient population. This could ultimately change the current recommendations.   "
54223|NCT02575846|"     The purpose of this study is to determine which type of food results in a shorter hospital     stay and better overall outcome for babies born with gastroschisis.   "
54224|NCT02575833|"     A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in subjects with     stable angina to evaluate the effect of AMG 334 compared to placebo on exercise time during     an exercise treadmill test (ETT)   "
54225|NCT02575820|"     The investigators sought to examine the effects of 'old' red blood cells on mortality and     morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators     hypothesis is that patients have an increased risk of mortality and infection after 'old' red     blood cells transfusions compared with those who received 'new' transfusions.   "
54226|NCT02575807|"     This 2-part, Phase 1/2 study will test investigational cancer drugs known as CRS-207,     epacadostat, and pembrolizumab. The purpose of this study is to find out how safe it is to     give the investigational drugs to women with platinum-resistant ovarian, fallopian tube, or     peritoneal cancer and if it helps patients with these types of cancer live longer or can help     shrink or slow the growth of cancer.   "
54206|NCT02576067|"     Vascular inflammation, a central feature of atherosclerosis, participates in the initiation,     perpetuation and instability of plaques. Multiple clinical trials of cholesterol lowering     therapy with statins have demonstrated that reductions in atherosclerotic cardiovascular     disease (CVD) events are associated with reductions in both LDL cholesterol (LDL-C) and the     systemic inflammatory mediator C-reactive protein (CRP). The Cardiovascular Inflammation     Reduction Trial (CIRT) investigates if an anti-inflammatory agent commonly used in rheumatoid     arthritis (low dose methotrexate (LDM)) can reduce CV morbidity and mortality among patients     with a prior myocardial infarction or angiographically demonstrated multivessel coronary     artery disease (GCO#13-1467).      In this ancillary CIRT imaging study, the investigators propose to use this well validated     approach by non-invasive serial FDG-PET/CT imaging in a subset of patients enrolled in the     main CIRT trial to directly visualize vascular inflammation. Once the subjects are enrolled     in the main CIRT trial, baseline imaging will be done and follow up imaging will be done     approximately 8 months after the baseline imaging.      18FDG-PET imaging data will be acquired, analyzed centrally and results incorporated into the     main CIRT database. The investigators hypothesize that LDM treatment will result in a     significant decrease in plaque inflammation as measured by 18-FDG-PET/CT after 8 months as     compared to placebo.   "
54207|NCT02576054|"     This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1     Virus-Like Particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two     periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up     to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety     from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when     all subjects have completed their Month 7 visit or have been discontinued before that time.     The second analysis will be conducted at the end of study. The primary hypothesis tested in     this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks     postdose 3.   "
54208|NCT02576041|"     The aim of the study is to evaluate the effects of Bilastine on patients' attention and     reactivity levels by measuring psychophysical performance at a F1-high speed simulator     driving test.   "
54209|NCT02576028|"     Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important     differences between types and numbers of treatment sessions. Objectives are to investigate     effectiveness of Fascial Manipulation when associated to a standard protocol of care.   "
54210|NCT02576015|"     The interaction of analgesia and sedation ot their effect on the prognosis of surgical     patients still need to be elucidated.Currently, how to optimize intra-operative Analgesia and     sedation to improve the prognosis of surgical patients is still a mystery.Intra-operative     nerve block provided regional analgesia of the operated knee, which reduced the dosages of     sedatives and analgesics.Based on a pilot study,the investigators found a decrease of     post-operative adverse composite outcomes with the use of continuous femoral nerve block (2%     versus 7%) ,therefore, the investigators postulate that general analgesia with lighter     sedation in combination with peripheral nerve block could reduce the post-operative morbidity     compared with deeper sedation.This randomized controlled trial is designed to test this     hypothesis in patients receiving unilateral knee arthroplasty.   "
54211|NCT02576002|"     To describe the prevalence, incidence and current treatment and procedures patterns in a US     pediatric population with PAH in MarketScan database during the period 2010-2013   "
54212|NCT02575989|"     The purpose of this study is to demonstrate that the specific management will increase the     number of alive trauma patient arriving with a temperature > 35°C.   "
54213|NCT02575976|"     The purpose of this trial are to pragmatically investigate whether participation in a     comprehensive CR (i.e., exercise with education) program in a Latin American MIC results in     better functional capacity, cardiovascular risk factor control, health behavior,     disease-related knowledge, depressive symptoms and lower mortality when compared exercise     only CR or wait list control.   "
54214|NCT02575963|"     The study is a multicenter, open label Phase I/II trial.        1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose          cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion)        2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac225          alone (Phase 2 portion)   "
54215|NCT02575950|"     An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled,     double-blinded, split-pace (left/right) design trial to evaluate the efficacy and     tolerability of LEO 43204 in adults with moderate to severe acne.   "
54217|NCT02575924|"     In this study the suitability of two -sequential and single step- commercially available     culture media from the same brand was compared. The aim of such study is to verify whether is     possible to improve the efficiency of infertility treatments in those couples who usually     have a high cycle cancellation rate, such as poor responder patients and severe male     infertility. The study population is composed of couples attending the fertility clinic: to     this purpose all those couples approaching IVF treatments with a diagnosis of OAT,     cryptozoospermia, advanced maternal age and women with a poor responder diagnosis were     recruited. IVF treatments were randomly set to be cultured either with two-step sequential     media or with one-step media to acquire data concerning the ongoing embryo culture     development and clinical outcomes.   "
54218|NCT02575911|"     The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ     keratomileusis (LASIK) flaps created with the LenSx® Laser.   "
54219|NCT02575898|"     To assess the feasibility of a creative writing intervention in an advanced cancer     population. Given it is a relatively simple intervention delivered by a non-clinician, the     investigators are interested in better understanding its pattern of effect on patient     psychological adjustment. The investigators aim to assess its feasibility in this study in     order to inform a future larger study that will utilize a control arm.   "
56128|NCT02550951|"     Its usefulness in implementing magnetic resonance angiography for postoperative follow-up of     lymph lymphedema should try to evaluate and compare lymphoscintigraphy.   "
54227|NCT02575794|"     This phase I trial studies the side effects and best dose of terameprocol in treating     patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as     terameprocol, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading.   "
54228|NCT02575781|"     Primary Objectives:      To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single     agent in patients with advanced solid tumors.      To evaluate the anti-tumor response of SAR428926 when administered as a single agent in     patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted     by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as     a single agent in patients with advanced solid tumors positive for the protein targeted by     SAR428926      Secondary Objectives:      To determine the overall safety profile of SAR428926 as a single agent. To characterize the     pharmacokinetics (PK) profile of SAR428926 and its metabolites.      To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate     the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response     in all treated patients.      To evaluate the benefit of primary prophylaxis on the occurrence of corneal     (keratopathy/keratitis) toxicity (Expansion cohorts).   "
54229|NCT02575768|"     Exertional angina is common symptom in patients with severe aortic stenosis (AS) without     obstructive coronary artery disease (CAD). Although reduced myocardial flow reserve is one of     the proposed explanations for angina, little is known about the pathophysiology.      This study aimed that adenosine-stress cardiac magnetic resonance can be used for the     assessment of myocardial perfusion reserve and suggest the pathophysiology of development of     angina in patients with severe AS without obstructive CAD.   "
54230|NCT02575755|"     Plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low     birth-weight and increased perinatal mortality. Whilst continuous prophylaxis is difficult to     implement, intermittent presumptive treatment in pregnancy (IPTp) has proved to be practical     and effective. In PNG, pregnant women currently receive IPTp using sulfadoxine-pyrimethamine,     however, this therapy has the potential to be compromised by parasite resistance.      The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and     efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New     Guinea women. The study will comprise of two sub-studies:      (i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety,     tolerability and preliminary efficacy study of AZI-PQ in pregnancy.   "
54231|NCT02575742|"     The reason chronic constipation (CC) becomes commoner with age is not fully understood. New     studies suggest that bowel contraction patterns, dietary fibre and gut bacteria are important     and may differ in older people. Since CC reduces quality of life and is a major reason why     elderly are admitted to hospitals and residential care, there is a need to understand how     these factors change with age.      Currently, placing a pressure sensing catheter inside the large intestine (pancolonic     manometry) is the gold standard way to measure how well it contracts. However this involves a     camera test (colonoscopy) which is invasive with risks of bowel perforations (~80/100,000).     The risk is higher with age (64-80yr: ~90/100,000; 80+yrs: ~120/100,000), making it unethical     for elderly.      A technique called the 3D-Transit System has been developed, involving a small ingestible     capsule, containing a 'trackable' electromagnet. By tracking movements of the capsule     swallowed by participants, it provides precise detailed information on the capsule     progression inside the whole gut and large bowel's contractile activity in real-time. It is     minimally-invasive and radiation-free, making it possible to assess elderly for the first     time.      This study aims to assess how bowel contraction patterns, dietary fibre intake and gut     bacteria differ between young and older adults (with and without CC), to better understand     why CC is more common in elderly.      It is a pilot, 4 arm, single centre, observational study involving 60 women aged 18-40 years     and 70-90 years (15 non-constipated and 15 with CC for each age group). The study lasts 3     weeks, containing 2 weeks of run-in period and 1 week of study period.      The four groups participants will be asked to: swallow 2 capsules to assess their large     bowel's contractile function using the 3D-transit system; provide stool samples to analyses     their gut bacteria; and complete questionnaires to assess their gastrointestinal symptoms.   "
54232|NCT02575729|"     Purpose: To compare the outcome between sonography-guided steroid injection and direct     steroid injection on carpal tunnel syndrome(CTS).   "
54233|NCT02575716|"     The objective of this study was to evaluate intubating condition using the McGrath® VL Series     5, with and without muscle relaxant   "
54234|NCT02575703|"     This type of study is called a radiolabeled study. For this study, LY3023414 has been     specially prepared to contain the radioactive carbon atom [¹⁴C]. [¹⁴C] is a naturally     occurring radioactive form of the element carbon. Adding a low dose of radiation to the study     drug does not change how the drug works but helps to identify when the drug appears in the     blood, urine, breath, and stool after it is given. The study will last about 15 days for each     participant, not including screening. Screening is required within 28 days prior to     enrollment. This study is for research purposes only and is not intended to treat any medical     condition.   "
54235|NCT02575690|"     Potential protective cardiovascular effect of Spirulina maxima supplementation was studied in     a double-blind placebo-controlled trial of obese subjects with treated hypertension, each     randomized to receive spirulina or a placebo.   "
54237|NCT02575664|"     Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity     for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1     -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist     at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up     to two-fold duration of action and it is approximately 30-fold more potent when compared to     morphine.      Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low     dose patches are recommended for treatment of moderate pain for example osteoarthritis pain.     It is known that well treated pain even preoperatively may prevent prolonged postsurgical     pain.      In the present study the effects of low dose buprenorphine on postoperative pain and recovery     were assessed.   "
54238|NCT02575651|"     Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this     study will be to investigate the safety and tolerability of Fluzoparib Capsule when given     orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic     profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.   "
54239|NCT02575638|"     This is a single-arm, non-randomized feasibility and Phase I trial of 20(S) Camptothecin     Propionate administered orally. CZ48 will be administered in successive cohorts of 1 patient     per participating site until hints of toxicity (grade 2 or worse adverse events related to     the drug) are observed. Then cohorts of 3+3 patients will be treated. CZ48 will be     administered orally daily (1 course = 4 weeks). No pre-medications will be administered.     Patients will be asked to drink up to one gallon of fluid daily if possible to flush the     bladder to mitigate cystitis. Cystitis is an anticipated toxicity as CZ48 is a pro-drug of     CPT (Camptothecin)   "
54240|NCT02575625|"     Hypothesis of this study is the existence of a relation between parameters measured by     FibroScan® FS 502 according to our non invasive method and liver steatosis condition.      This proof of concept validation is made up of two steps:        -  Step 1: feasibility study of the method on 10 healthy volunteers        -  Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25          between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom          the histological answer is clean steatosis (NAFLD).      Experimental procedures consist in:        -  Fibroscan measure, preceded by tracking ultrasonography.        -  liver MRI (for substudy about MRI comparison, in step 2)        -  a blood test for biological assessment of liver functions   "
54241|NCT02575612|"     The study aims to evaluate the ability of representative vacuum-assisted minimal invasive     biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients     after neoadjuvant chemotherapy (NACT).   "
54242|NCT02575599|"     The overall aim of this study is to assess the effectiveness of a web-based Guided     Self-Determination program among adults with type 2 diabetes in general practice in order to     improve diabetes self-management behaviours and HbA1c through enhanced patient activation,     self-care competence, and autonomy.   "
54243|NCT02575586|"     The main objective of this study is to analyze the effect of dry needling of the soleus     muscle to modulate muscle tone in healthy non-injured subjects. The secondary objective is to     study if effects occur due to changes in the neural or mechanical component (or both).      Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the     soleus muscle produces changes in muscle tone varying the passive resistance torque at a rate     of 180º/ s.   "
54244|NCT02575573|"     The investigators will retrospectively examine the connection between resuscitation decisions     of admitted patients at the ED of the University Hospital of Basel and several demographic     and health related measures. Additionally there will be an examination, which patient     characterestics may have lead to patients not having been asked about resuscitation     decisions.   "
54245|NCT02575560|"     EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small     cell lung cancer with EGFR gene mutation. The median progression free survival time is around     11 months with the first generation EGFR-TKI. Patients with acquired resistance with first     generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug     administration maybe prolong patients PFS and evently prolong OS.   "
54246|NCT02575547|"     This is an prospective，open-label, none-interventional, observational， multicenter phase II     clinical trial. The purpose of this study is to observe the effect of neoadjuvant     chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in     locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of     patients' nutrition status during the treatment and the connection between nutrition changes     and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT     and provide data and basis for further study。   "
54247|NCT02575534|"     The aim of this study is to determine if anti-arrhythmic drugs with a sodium channel-blocking     mechanism exert a detrimental electromechanical effect on cardiac function in patients     depending upon baseline intraventricular conduction and left ventricular function.   "
54248|NCT02575521|"     Despite theoretical benefits of intravenous agents, volatile agents remain popular. In a     study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial     hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and     intra-cranial pressure (ICP) were least with sevoflurane.      Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages     by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and     vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have     lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.      The well known pharmacodynamic advantages of intravenous anesthetics may give this group of     drugs superior cerebral effects when compared with inhalation anesthetics.   "
54263|NCT02575326|"     Little guidance is given to physicians caring for obese adolescents with asthma, however,     findings suggest that interventions designed to achieve asthma control in these patients are     necessary. Because of the psychosocial factors often associated with obesity and asthma     (e.g., low self-esteem, depression, and low quality of life) successful interventions should     incorporate a patient-centered approach. The proposed study design is a clinic-based,     randomized controlled trial (RCT) in teens with a history of asthma and who are overweight or     obese.   "
61523|NCT02480283|"     This study plans to evaluate the effects of chronic cannabis smoking on lung health by     evaluating its effects on pulmonary health, lung physiology and alveolar macrophage function.   "
54249|NCT02575508|"     This phase Ib/II trial studies the side effects and best dose of pan fibroblast growth factor     receptor (FGFR) kinase inhibitor BGJ398 when given together with fluorouracil, irinotecan     hydrochloride and oxaliplatin (combination chemotherapy) in treating patients with untreated     pancreatic cancer that has spread to another place in the body. Pan FGFR kinase inhibitor     BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride and     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving pan FGFR     kinase inhibitor BGJ398 together with fluorouracil, irinotecan hydrochloride and oxaliplatin     may be a better treatment for pancreatic cancer.   "
54250|NCT02575495|"     The major hypothesis to be tested is that there was no difference in the clinical outcome     between 7(short-course) and 14(traditional-course) days of antibiotic treatment for     asymptomatic bacteriuria early after kidney transplantation.   "
54251|NCT02575482|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     SUVN-D4010 in healthy male subjects following single or multiple ascending doses.   "
54292|NCT02574949|"     The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5     frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15     PPS) on radiation dose to the patient and the operator during coronary angiography and     intervention. In addition, investigators sought to qualitatively assess the effect, if any,     of the low frame rate on angiographic image quality.   "
56129|NCT02550938|"     To demonstrate that a primer aligner product can achieve similar results to the currently     marketed product.   "
54252|NCT02575469|"     Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g.     ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way     to measure exercise capacity is to perform a cardiopulmonary exercise testing.     Normal/reference values in health and disease relate to specific population and     subpopulations. The population in Israel is unique in its diversity.      Objectives: Data collection of exercise capacity assessment in health and illness in the     northern of Israel for future local database.      Population: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology     institute) and healthy volunteers evaluated as controls.      Study design: Prospective observational study. Participants will answer a health related     questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a     treadmill or a cycle ergometer.   "
54253|NCT02575456|"     A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and     Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)     in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.   "
54254|NCT02575443|"     The purpose of this study is to evaluated whether the depth of neuromuscular block may affect     the unicon value of anesthetic depth monitoring system (ADMS).   "
54255|NCT02575430|"     To evaluate the natural history of visual function in subjects with IRD phenotypically     diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or     LRAT gene mutations.   "
54256|NCT02575417|"     This study will determine the feasibility of using an end-of-life conversation game (called     My Gift of Grace) as a community engagement activity series to help caregivers, patients     with chronic illness, and/or their families perform advance care planning.   "
54257|NCT02575404|"     This study is a dose escalation of GR-MD-02 with the standard therapeutic dose of     pembrolizumab in patients with advanced melanoma.   "
54258|NCT02575391|"     This study will evaluate whether a Whole Food Intervention reduces the frequency or severity     of esophagitis in patients receiving treatment for non-small cell lung cancer.      The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3     portioning cups, equal to approximately 12 ounces, taken daily before starting radiation     therapy.   "
54259|NCT02575378|"     The optimum regimen of maintenance treatment after first-line chemotherapy in patients with     metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the     efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus     Chinese Traditional Medicine.      In this Prospective, open-label, randomised controlled trial, the investigators will recruit     159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease     evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and     be randomised into two group, capecitabine metronomic chemotherapy only as control group and     the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This     treatment regimen will be continued until progression, death, or an unacceptable adverse     event.      The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall     survival (OS), quality of life (QOL) and toxic effects.   "
54260|NCT02575365|"     This is a 24-month, open-label, multicenter study with a single treatment arm design.      Primary objective of this study is:      -To investigate the effects of Fingolimod on cognitive performance in highly active relapsing     remitting multiple sclerosis patients      Secondary objectives of this study are:        -  To investigate the correlation between the effect of fingolimod on cognitive          performances and MRI data.        -  To evaluate the effect of fingolimod on biomarkers (24 hydroxy cholesterol, osteopontin          and matrix metalloproteinases) related to neurodegeneration        -  To investigate the effect of fingolimod on brain gray matter atrophy and thalamic          atrophy.      Polulation We will recruit a minimum of 80 relapsing remitting MS (RRMS) patients according     to the McDonald criteria.   "
54261|NCT02575352|"     CPC REGISTRY is a multi-center, international, prospective, open-label, observational study     on the use of injectable calcium phosphate cements for the treatment of bone defects in     adults. All patients will be treated with any of the two injectable calcium phosphate bone     substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard     clinical practice and according to the information provided by GRAFTYS manufacturer in     respective device Instructions For Use (IFU).   "
54264|NCT02575313|"     This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter,     honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and     neck cancer patients undergoing standard treatment.   "
54265|NCT02575300|"     This is a prospective phase II open-label trial, stratifying patients equally into two     cohorts consisting of carcinoid tumors and pancreatic neuroendocrine tumors (pNETs). The     purpose of this study is to test any good and bad effects of the study drug called Ibrutinib.      The study population will consist of adult patients with histologically confirmed low to     intermediate grade NETs of the GI tract, lungs and unknown primary (carcinoid tumors) or     pNETs. All patients must be confirmed to have advanced disease. The study will enroll up to     51 patients in two cohorts (30 carcinoid and 21 pNET patients).   "
54293|NCT02574936|"     The purpose of this study is to reduce the volume of dead space by a modification in kardakis     flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and     hematoma formation, skin degradation and recurrence rates.   "
54294|NCT02574923|"     The aim of this study is to assess the safety and effectiveness of autologous bone marrow     mononuclear stem cells in patients with cerebral palsy.   "
54266|NCT02575287|"     White light endoscopy remains the gold standard technique to evaluate gastrointestinal tract.     Gastroesophageal Reflux Disease (GERD) is defined as presence of reflux symptoms (heartburn     and regurgitation) associated or not with lesions in esophageal mucosa. Based on findings at     videoendoscopy GERD patients can have a complicated reflux disease (erosive esophagitis) or     not and be considered as a non erosive reflux disease (NERD). 60% of GERD patients have     normal endoscopy (NERD) and requires further studies to achieve a definitive diagnosis. Based     on this fact is that the study will be focus on NERD patients.      Recently an image-enhanced endoscopic technology using a pre-processor band-limited light     called Optical Enhancement system (OE system™), was developed (Pentax Medical). This new     technology combines digital signal processing with optical filters that limit the spectral     characteristics of the illumination light. The new innovated optical filters achieve higher     overall transmittance by connecting the peaks of the hemoglobin absorption spectrum (415 nm,     540 nm and 570 nm) creating a continuous wavelength spectrum. There are two modes with     different OE filters (Mode 1 and Mode 2). Mode 1 is designed to improve visualization of     microvessels with a sufficient amount of light, and Mode 2 is designed to improve contrast of     white-light observation by bringing the color tone of the overall image closer to that of     natural color.      In addition, new scopes has been developed which combines high definition images with optical     magnification called Magniview™. These scopes increase the image up to 136 times with a     better quality of image than standard scopes without optical zoom. Sharma et al. evaluated     esophageal changes in NERD patients using a similar pre-processor filter called Narrow Band     Imaging (NBI). They found that a significantly higher proportion of patients with NERD had an     increased number, dilation and tortuosity of the microscopic intrapapillary capillary loops     (IPCLs), and were considered the best predictors for diagnosing NERD. They used optical     chromoendoscopy technology (NBI) associated to magnification scopes (Olympus GIF Q240Z,     115x), but they did not evaluated if the contribution with this technology to the     observations found in GERD patients were as a result of the NBI or the magnification scopes.     The investigators opinion is that chromoendoscopy is useful but is the magnification what     makes up the difference.   "
54267|NCT02575274|"     The purpose of this experimental study in humans is to evaluate and compare, the regenerative     therapy for the treatment of peri-implantitis using different bone substitutes and absorbable     membranes with surgical therapy without the use of materials for regeneration.   "
54268|NCT02575261|"     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell     immunotherapy in treating with EphA2 positive malignant glioma patients.   "
54269|NCT02575248|"     This study aims at investigating the fertility outcome of endometriosis suppression with     dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month in     endometriosis patients stage I and II.   "
54270|NCT02575235|"     This study is to assess the impact on the prevention of sarcopenia after taking     cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age     of 60   "
54271|NCT02575222|"     This study will evaluate the use of nivolumab before surgery in patients with high-risk clear     cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may     help activate the immune system by blocking the function of an inhibitory molecule, PD-1.   "
54272|NCT02575209|"     Individuals with schizophrenia have important and persistent deficits in multiple     neurocognitive domains as well as in the Social Cognition (SC). SC refers to the mental     operations underlying social behavior, and it is understood as a multidimensional construct     that comprises emotional processing (EP), social perspective and knowledge, attributional     bias and theory of mind (ToM) or mentalizing. Mentalizing and EP skills have been the two     most studied subdomains of SC in schizophrenia. Both domains have been found to be impaired     in chronic schizophrenia patients as well as in patients in early stages of the illness. In     this context, although negative symptoms may play and important role, females seem to perform     better than males in ToM and EP tasks, suggesting the presence of gender differences in the     SC skills in patients with schizophrenia. However, to our knowledge, there are no studies     that have explored the gender-related differences between cognitive and affective ToM and its     relationship with the EP performance in schizophrenia patients of recent diagnosis comparing     with healthy subjects.      In this line, the main objective of this project is to analyze the influence of gender in the     cognitive and affective ToM abilities, in a group of patients with schizophrenia in early     stages of the illness comparing with healthy subjects. Secondarily, this study pretends to     explore the association between EP skills and affective ToM tasks performance in males and     females with and without recent diagnosis of schizophrenia.   "
54273|NCT02575196|"     Cardiac Arrest is among the leading causes of death, with survival still well under 50% and     the majority of the survivors suffering from moderate to severe neurologic deficits. The     human, social and economic costs are staggering.      During resuscitation, damage is mitigated if chest compressions and other medical care are     optimal, allowing some blood to reach the brain and some oxygen to reach the cells. Once the     heart starts beating again, which is called return of spontaneous circulation, brain     perfusion is reestablished, but usually not to normal. The now damaged brain is very fragile,     can be sensitive to any changes in blood pressure or metabolic abnormalities, and swelling     might set in. Hypoperfusion can persist, without the clinician's knowledge. All of these     events further damage the brain and diminish the odds that the patient will regain a normal     life. Therefore, the hours following return to spontaneous circulation are critical to the     patient's future recovery, and constitute a window of opportunity to maximize the brain     ability to heal.      In order to optimize resuscitative efforts and post-arrest management, clinicians must know     what is actually happening with the most vital organ, the brain. The problem is that it is     very difficult to do in a comatose patient. The available technologies only reveal indirect     evidence of brain suffering, like the swelling on CT-scans, but not to continuously evaluate     at the bedside if the brain actually receives enough blood.      The FDA recently approved a device named the c-flow, made by ORNIM. This device looks at red     blood cells in the brain and the speed at which they move to evaluate an index of cerebral     perfusion. It does so with sensors put on the patient's forehead, which emit and detect     ultrasounds and infrared light. This index can inform the clinician about the amount of blood     flow the brain receives, and it can be put in place very quickly, even during resuscitative     efforts, and without any danger for the patient.      The study looks at how well the information obtained with the c-flow matches the one obtained     from other indirect indices and, more importantly, how well it predicts patient outcome. The     investigators wish to establish threshold values of this index of perfusion that predict a     good recovery so that this information may be used to optimize patient's neurological outcome     in the near future.   "
70710|NCT02360228|"     Investigating the effects of non-invasive transcranial current stimulation as a treatment for     auditory hallucinations in patients with schizophrenia.   "
54295|NCT02574910|"     Children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency tend to     have elevated circulating levels of androgens, which can accelerate skeletal maturation and     adversely impact adult height. Additionally, these children require supraphysiologic doses of     hydrocortisone to suppress secretion of adrenal androgen precursors, and this treatment can     retard linear growth. This study seeks to use oral abiraterone acetate (Zytiga)as an adjunct     to approved CAH therapy (oral hydrocortisone and fludrocortisone) for pre-pubescent children     with classic 21-hydroxylase deficiency in order to reduce daily requirement of     hydrocortisone. In this Phase 1 study, the investigators will determine the minimum effective     dose of abiraterone acetate that normalizes androstenedione levels during the 7-day Treatment     Period.   "
54300|NCT02574845|"     The primary objective of this trial is to investigate the relative bioavailability of     rosuvastatin when given alone (Reference treatment, R) compared to when given together with     one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500     mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).   "
54274|NCT02575183|"     The lack of proven waterpipe smoking cessation interventions makes it important to explore     interventions proven effective for cigarette smoking cessation. The investigators hypothesize     that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained     quit rate at 12 weeks compared to placebo. The investigators propose to conduct a randomized     double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix),     in two parallel groups each consisting of 76 habitual waterpipe smokers who are willing to     quit. Potential participants will be approached in cafés, word-of-mouth and through media and     will be invited to the American University of Beirut Medical Center to complete study     procedures. Both study groups will receive the same behavioural intervention in combination     with either Varenicline (Chantix), an FDA approved drug indicated for use as an aid to     smoking cessation treatment, or placebo. Participants will complete study procedures in four     visits. During visit-1 the informed consent process, baseline assessments and randomization     will be completed and Varenicline (Chantix) or Placebo will be initiated together with the     behavioural interventions. The behavioural intervention will be continued over the next 2     visits. An end of treatment visit 12 weeks after quit date will be dedicated to assessing     sustained quit rate and other outcomes.   "
54275|NCT02575170|"     Introduction: Intravenous infusion of amino acids during cesarean delivery in mothers and     neonates improves neonatal growth. Amino acid before and during anesthesia also prevents     hypothermia and associated untoward effects.      Method: After ethical approval, this prospective randomized double blind controlled study is     being conducted in the university hospital of BPKIHS. Seventy six parturients (ASA 1 & 2)     undergoing cesarean delivery without fetal distress, intrauterine growth retardation,     congenital malformation or premature labor will be enrolled.      For a period starting from approximately one hour prior to spinal anesthesia, Group 1 and     Group 2 patients will receive 200 ml of amino acid and lactated ringers solution respectively     at 2 ml/kg/hr. The ambient operating room temperature will be maintained near 23º C. No     heating methods will be applied apart from covering with a blanket.      Primary outcome measure will be neonatal rectal temperature at 0, 5 and 10 min after birth.     Secondary outcome measures will be APGAR scores and suckling reflex in the newborn, change in     rectal temperature relative to baseline and discomfort related to cold sensation in the     mother and the occurrence of shivering and duration of hospital stay both in the mother and     newborn.   "
54276|NCT02575157|"     Bisphosphonates (BP) are widely used in the prevention and treatment of osteoporosis in     postmenopausal women and older men. Recently, there has been concern about the risk of     adverse events after several years of using these agents. This has resulted in a publication     from the Food and Drug Administration that suggested that, for many individuals, a holiday     from bisphosphonates might be considered after 4-5 years of continuous use. In that     publication there was little, if any, guidance on how clinicians should proceed after the     holiday is initiated.   "
54277|NCT02575144|"     This phase III study, open-label, randomized study investigating lenalidomide and     dexamethasone with and without biaxin in subjects with newly diagnosed, previously untreated     MM. Eligible subjects will be randomized in a 1:1 ratio to receive a regimen consisting of     either biaxin, lenalidomide, and low-dose dexamethasone (BiRd arm), or lenalidomide and     low-dose dexamethasone (Rd arm). 306 patients will be included (50% in Spain (153) and 50% in     the USA (153)   "
54278|NCT02575131|"     Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there are     more overweight than underweight people in the world. This is partly caused by increased     energy, or food intake. One of the physiological factors regulating the food intake pattern     is satiety. Though the regulation of food intake has been studied quite extensively, the     underlying mechanisms are not well elucidated yet and still new factors involved in this     regulation are being found. Therefore, in this study the investigators aim to develop an in     vitro screening tool combined with an in silico model for prediction of satiety, for cost-     and time - effective screening of satiating properties of new and existing complex food     products and (functional) ingredients, based on actual satiety scores measured. A second aim     of the Wholegrain Satiety project is to evaluate satiating properties of different types of     wholegrain breads and other oat based products, both for validation purposes and to     strengthen the scientific evidence for health benefits of wholegrain products. As part of     this study, acute satiety scores after consumption of various breakfast products in     well-controlled clinical conditions will be compared with satiety scores obtained in 'at     home' test conditions.      Objective: The current study aims to compare the acute satiety effect of carbohydrate     breakfast products.   "
54279|NCT02575118|"     It has been reported that therapy with polymer-based dental filling materials was associated     with higher concentrations of bisphenol A in saliva and urine directly after the treatment.     The objective of the present project is to gain knowledge about the concentration of     bisphenol A in saliva and urine before and after treatment with polymer-based dental filling     materials, using sensitive analytical methods.   "
54280|NCT02575105|"     We tested the hypothesis that BIS values are altered in pediatric patients with hydrocephaly.     We also tested the hypothesis that BIS values are altered in adult post cerebral hemorrhage     patients with hydrocephaly undergoing ventricular-peritoneal shunt placement   "
54296|NCT02574897|"     The purpose of this randomized trial will evaluate whether providing clinicians with daily     reports from a well-validated, standardized, patient-centered electronic symptom survey tool     (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult     inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to     stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm     with standard of care daily clinician interviews or (2) standard of care plus daily     electronic symptom surveys, the results of which will be sent to clinicians electronically.   "
54297|NCT02574884|"     The study consists to Identify viral variants involved in the transmission of hepatitis C and     characterize the antigenic and functional properties of their envelope glycoproteins at very     early stage of infection (before seroconversion).   "
54298|NCT02574871|"     This study consists of psychological and biological data collection for identification of the     chronic stress presence in healthy adult subjects. The psychological data collected were the     results provided by three different instruments: ISSL, PSS and SRRS. The biological data     collected were the blood pressure, the skin temperature, the galvanic skin response, and the     heart rate variability in time and frequency domain.   "
54281|NCT02575092|"     Contrast-induced nephropathy has become the third-largest cause of hospital acquired acute     renal injury, and which morbidity is only less than that of renal hypoperfusion and renal     toxicity of drugs, about 11%of all cases. Pathophysiologic mechanisms of contrast-induced     nephropathy(CIN) is not entirely clear yet. May be associated with renal hemodynamic changes,     medullary ischemia because of renal blood flow reduction, oxidative stress, endothelial     dysfunction ,contrast agents damage the epithelium of renal tubular directly and so on.     Currently the studies have proved that inflammation(CRP, TNF-α and NF-қB) played a role in     CIN.It is well-know that the hyperhomocysteinemia(HHCY) is a independent risk factor for     cardiovascular diseases, which has pro-inflammatory effects. Researches showed that Hcy     stimulated CRP generation by the NMDAr-ROS-ERK1 / 2 / p38-NF-қB signaling pathway and     triggered inflammatory response. We will compare the CIN incidence of different plasma Hcy     levels in adults hypertensive patients undergoing coronary artery diagnosis and treatment(CAG     and PCI). CIN was defined as an absolute ≥0.5mg/dl or a relative ≥25% increase in the serum     creatinine level at 48 hours after the procedure. The relationship between decreased plasma     Hcy levels and blood pressure values by using Enalapril Maleate and Folic Acid Tablets(as the     program-based antihypertension) and recovery of CIN has been observed. Using univariate and     multivariate Logistic regression to analyse the relationship between HHcy and CIN, and taking     receiver operating characteristic (ROC) curve to select the best Hcy plasma levels that which     can predict the CIN and the probability. This study will help us to understand the     relationship between HHcy and CIN that course of the procedure in adults hypertensive     patients, preoperative plasma Hcy levels can predict the incidence of CIN and whether     Enalapril Maleate Folic Acid tablets can reduce the CIN of hypertensive patients with HHcy.     Which has important clinical significance. This study also offer feasibility for further     research that HHcy plays a role in pathogenesis and specific signaling pathways of CIN.   "
54282|NCT02575079|"     The purpose of this study is to see if applying parafilm as an external barrier on the     central line in children having a bone marrow transplant helps to prevent central line     associated bloodstream infection(s) and also to assess the ease of use of parafilm.   "
54283|NCT02575066|"     Radiotherapy (RT) alone is able to induce a clinically significant effect with a variable     pathologic response (a pathological complete remission, pCR, defined as ≥ 95%, or ≤ 5%     remaining visible tumour cells) in only about 10% of cases. A prior phase I study (PASART-1;     NCT01985295) suggested that 25 x 2 Gy preoperative RT in combination with once daily 800mg     oral pazopanib is feasible, while inducing tissue replacing tumor that can consist of     fibrosis and necrosis in 40% of thus treated patients.   "
54284|NCT02575053|"     Study objectives      Primary objective:      This study wants to evaluate the safety of a latex safe protocol as proposed by the     Australasian Society of Clinical Immunology and Allergy. In other words,the investigators     hope to demonstrate that patients with known latex allergy or latex sensitisation can be     treated safely in operating theatres without special requirements towards scheduling provided     that all powdered latex gloves are removed from the OR environment( preparation rooms,     theatres, recovery room and surroundings). In contrast, earlier guidelines require the     theatre to be left unused during at least 3 hours before a patient with suspected latex     allergy can be operated on in this theatre.      Secondary objectives:        -  The investigators want to evaluate to what extend patients who report a latex allergy          show risk factors of latex allergy.        -  To investigate to what extend latex allergy was proven by laboratory testing or skin          testing in patients who report a latex allergy.        -  Type of latex allergic reaction when patients report a latex allergy.        -  The level of satisfaction of surgeons and OR scheduling staff with the new latex safe          protocol and with the switching to powder free latex gloves.   "
54285|NCT02575040|"     The gut microbiota is determined to constitute a microbial organ which has pivotal roles in     the intestinal diseases and body's metabolism. Evidence from animal and human studies     strongly supports the link between intestinal bacteria flora and inflammatory bowel diseases.     Lots of studies showed its efficacy in treatment of severe Clostridium difficile colitis.     Corticosteroid dependence in patients with ulcerative colitis (UC) and Crohn's disease (CD)     is an important clinical problem and maintenance of steroid-free remission is a key treatment     goal. Early studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC)     and Crohn's diseases have also met with success. This is an first step into investigating the     potential efficacy of standardized FMT through terminal ileum for UC and CD, the     investigators propose to determine the efficiency and safety of FMT in a series of 80     patients with moderate to severe UC and CD.   "
54286|NCT02575027|"     This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating     patients with glioblastoma multiforme that has come back after standard chemoradiation. A new     radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation     delivery by improving dose coverage to the treatment target, while reducing the dose to     surrounding normal tissues.   "
54287|NCT02575014|"     The primary objective of this study is to assess the safety, tolerability and toxicity of     preoperative HBOT in patients undergoing a pancreaticoduodenal resection for premalignant and     malignant tumors of the common bile duct, periampullary and duodenum.   "
54288|NCT02575001|"     The aims of this study are two fold: To show whether there is an increased environmental or     genetic susceptibility to stress in patients with T1D and whether it influences diabetes     management. And to develop a strategy for the assessment and treatment of patients with T1D     and an increased risk for development of psychopathology under stress.   "
56085|NCT02551510|"     Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure     to port plant in terms of cosmetic results and time savings at comparable risk for wound     infection.   "
54289|NCT02574988|"     The multicenter registry of patients with severe cutaneous adverse reactions among tertiary     medical institutes in Thailand to study clinical characteristics, etiologies, therapeutic     outcomes, quality of life, and the values of in vitro drug allergy diagnosis for the     confirmation of the causative drugs   "
54290|NCT02574975|"     Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable     symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow     limitation and often associated with airway hyper-responsiveness and airway inflammation.     About 1-18% of the global population suffered from the disease, causing huge economic burden     for patients and countries. Airway reactivity measurement is an important way of diagnosis of     asthma. Methacholine (Mch) bronchial provocation test(BPT) is the gold standard for the     determination of airway reactivity, and other measuring methods(like adenosine     monophosphate(AMP)-BPT, leukotriene D4(LTD4)-BPT, Astograph-BPT, etc.) were also brought into     hot research fields. The investigators' purposes were to compare different kinds of     methodologies(Mch,AMP,LTD4-BPT, Astograph-BPT) assessing airway responsiveness and to     investigate treatment efficacy of budesonide /formoterol in asthmatics.   "
54291|NCT02574962|"     The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in     Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.   "
54301|NCT02574832|"     Cervical incompetence complicates approximately 1 in 500 pregnancies . Those women with     cervical incompetence are at risk for second trimester spontaneous abortion and preterm     labor. Cervical cerclage reduces these risks but must be performed under general or neuraxial     anesthesia. Some anesthesiologists prefer neuraxial anesthesia, as it reduces fetal exposure     to medications and avoids the risks associated with loss of maternal airway reflexes under     general anesthesia. Spinal anesthesia, in particular, has the added advantage of being     technically simple while still providing a rapid, dense sensory block. For cerclage     placement, patients require a sensory block from the T10 to S4 dermatome in order to cover     sensation from the cervix as well as the vagina and perineum. Patients presenting for     cerclage under spinal anesthesia pose a dosing challenge given the physiologic changes     associated with pregnancy. As women progress with their pregnancy, they require lower doses     of intrathecal local anesthetic to achieve similar block level. Multiple studies have     demonstrated that these changes start during the second trimester. Inadequate sensory     coverage with a spinal anesthetic typically necessitates conversion to general anesthesia,     causing additional time wasted and added risk to the patient and fetus. Anecdotally, this is     the reason why some anesthesiologists choose general anesthesia for patients undergoing     cerclage over a spinal anesthetic. As there is currently no literature determining the     correct dosage for these patients, we propose a dose-response study to determine the ED90 of     intrathecal lidocaine for adequate anesthesia for elective cervical cerclage placement.The     findings of this study will help determine the minimum dose of intrathecal lidocaine     necessary to provide adequate spinal anesthesia for cervical cerclage for 90% of women. This     will help decrease the frequency of inadequate anesthesia for cervical cerclage.   "
54302|NCT02574819|"     This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the     safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation     in patients with advanced illness.   "
54303|NCT02574806|"     Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and     prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP     plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and     diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as     expression of renal maturity could explain the subsequent decrease in serum values. This     would suggest that, in healthy newborns, BNP values should be found within a given ranges.     However, the evidence suggests an important variability in BNP values 2 - 4. In the other     hand, in the newborn with respiratory distress BNP could have a high negative predictive     value to rule out acute myocardial processes, as responsible for clinical deterioration, from     infectious, metabolic or respiratory processes; with a potential of improvement in medical     care. Even the increased use of this biomarker in clinical practice, until our knowledge, BNP     normal values remain unknown in the healthy newborn. Therefore, the investigators performed a     pioneer study to establish normal values in healthy newborn population. Multi-center,     prospective and observational study was carried out. Objective: To establish normal BNP     values in healthy newborn.   "
54304|NCT02574793|"     Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects     with normal glucose tolerance or impaired glucose regulation. People with Growth     Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose     metabolism. Glycemic variability is poorly studied in the nondiabetic individuals. The aim of     the study is to investigate the characteristics of glucose fluctuations in the newly     diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals.   "
54305|NCT02574780|"     The stage and lymphedema size can be detrimental to the quality of life and health of women,     because the increase in circumference and member of the weight causes limitations in     activities. Previous studies have shown that patients with lymphedema should not perform high     intensity exercises, these exercises would cause the increase of lymphedema. Already, in     current studies show that muscle strength exercises when properly applied, with controlled     intensity and time, can help to reduce lymphedema. Thus, the main objective of this study is     to compare the standard treatment of lymphedema through complex physical therapy versus the     application of strengthening exercises for upper limbs together with complex physical     therapy. The study design is a randomized controlled clinical trial. Participate in the study     50 patients, who will be allocated into two groups, group 1 (n = 25): Complex Physical     Therapy; Group 2 (n = 25): Complex physical therapy in an exercise protocol, which will     receive treatment twice a week for eight weeks. All patients will receive treatment and will     be informed of the free and informed consent form at the beginning of the research. They will     be met: the report cards, dynamometer testing and filling out questionnaires at the beginning     and end of the study.   "
54318|NCT02574611|"     An injury to the spinal cord (SCI) results in numerous medical complications, including     gastrointestinal (GI) function. Individuals with SCI may experience severe constipation     (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel     evacuation. While various treatments and medications have been established to address this     complication, there is little knowledge relating to the overall colonic motility. However,     new technology such as High Resolution Colonic Manometry allows physicians to visualize high     pressure contractions inside the colon, leading to a greater understanding of typical     motility, a more accurate diagnosis, and an effective treatment. In this study, the     investigators propose to use this technology to understand the effects of SCI on colonic     motility by comparing to normal colonic function observed in able-bodied (AB) individuals. In     addition, the investigators plan to study the effects of pharmacological treatments, such as     neostigmine, on promoting peristaltic contractions in the colon as it is delivered across the     skin.   "
54306|NCT02574767|"     In Chile, 1 out of 4 pregnant women is obese (BMI > 30 kg/m2). This impacts negatively the     health of the mother and the offspring during pregnancy. Lifestyle interventions are the     primary prevention strategy for gestational diabetes in obese women; however, these     interventions have shown null or limited effectiveness. In animals, n-3 long-chain     polyunsaturated fatty acid (n3LC-PUFAs) have shown to increase insulin sensitivity through     higher production and secretion of adipokines, enhanced fatty acids oxidation, reduction of     lipogenesis, and direct anti-inflammatory effects; however evidence in humans and during     pregnancy is still very limited. Combining a lifestyle intervention with n3LC-PUFAs     supplementation could enhance the metabolic control of obese pregnant women. Objective: to     assess the effectiveness of two prenatal nutritional interventions (home-based diet and     physical activity counseling and/or n3LC-PUFAs supplementation) delivered to obese pregnant     women in achieving better metabolic control in both the mother (lower incidence of     gestational diabetes mellitus) and the offspring (lower incidence of macrosomia and lower     prevalence of insulin resistance at birth).      Methods: this study is a cluster-randomized trial in which obese pregnant women from 12     primary health care centers (PHCC) will be stratified by socio-economic status (SES) and     randomized to one of four parallel study arms. We will recruit 1000 women allocated to: 1     Home-based Diet and physical activity (PA) plus n3LC-PUFAs supplementation (Intervention     Group 1, n=250); 2. Routine diet & PA counseling care plus n3LC-PUFAs supplementation     (Intervention Group 2, n=250); 3. Home-based Diet and Physical activity plus placebo for     n3LC-PUFA supplementation (Intervention Group 3, n=250); 4. Routine diet & PA counseling plus     placebo (Control Group, n=250). Expected results: we expect that the intervention will     contribute to achieving a better metabolic control during pregnancy. Ultimately, we expect     that this study will contribute to advance the understanding of how to develop and implement     effective actions to promote healthier pregnancies and therefore, healthier lives for mothers     and their offsprings.   "
54307|NCT02574754|"     The purpose of this study is to assess the 2012 bioequivalence statistical criteria for     warfarin, a narrow therapeutic index drug, set forth in the draft guidance issued by the Food     and Drug Administration (FDA).   "
54308|NCT02574741|"     The study will consist of two main elements: the enrollment of 72 children aged 6-11 years     with ASD and low language competency to receive a thrice-weekly one hour language     intervention for 12 weeks; and, beginning at the same time, subjects will be equally     randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or     placebo for 12 weeks.   "
54309|NCT02574728|"     This study aims to determine the efficacy of daily sirolimus and celecoxib, with low dose     etoposide alternating with cyclophosphamide for pediatric participants with relapsed or     refractory tumors.   "
54350|NCT02574195|"     The main aim of the present study is to evaluate the prevalence of individual microvascular     and macrovascular complications among diabetes mellitus patients and to determine the     percentage of diabetes mellitus patients achieved HbA1c<7,0%.   "
54351|NCT02574182|"     Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in     healthy subjects and amnesic MCI.   "
54310|NCT02574715|"     This is a cross-sectional, multicenter observational study to assess quality of life in young     Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will     be conducted in standard clinical practice conditions at the private gynecology clinics and     during a single study visit.      Approximately 1,200 women who have been using the intrauterine delivery system (IUS) Jaydess®     as their contraceptive method of choice for 6 (±1) months will be included in the study.   "
54311|NCT02574702|"     1. Introduction:           The most common complication of loop ileostomies closure for rectal cancer patients          undergoing a low anterior rectum resection, is the superficial surgical site infection          (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a          retrospective study at our center, the investigators objectify that superficial surgical          site infection rate was reduced by more than a half by the application of a          contralateral drainage (Penrose ®) in primary loop ileostomy closure.        2. Objectives and Hypothesis:           Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop          ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for          rectal cancer) reduces the superficial surgical site infection.           Main objective: To reduce the rate of superficial surgical site infection by the          application of a contralateral drainage (Penrose ®) in surgical wound of primary loop          ileostomy closure.        3. Methodology:      Prospective and randomized clinical trial on the effectiveness of contralateral Penrose®     drainage implementation in those patients that have a primary loop ileostomy (by low anterior     rectum resection) closure to be able to know if the investigators can reduce the superficial     surgical site infection rate. Monitorization until 30 days after surgery   "
54312|NCT02574689|"     This pilot study represents an initial foray into delivering home-based individually-tailored     physical activity interventions for cancer risk reduction among African American women in the     Deep South.   "
54313|NCT02574676|"     This is an online registry to document the psychometric properties of SF-36v2 among patients     with AL Amyloidosis, to document patients' burden of disease, to better understand the     patient's experience and to follow quality of life issues using a variety of QOL measures.   "
54314|NCT02574663|"     This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a     single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients     with select relapsed or refractory solid tumors.   "
54315|NCT02574650|"     The purpose of this study is to assess the early safety and performance of the Mitralign     Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic     chronic functional tricuspid regurgitation (FTR).      The procedure will be performed with the PTVAS device using a non-surgical percutaneous     approach to tricuspid valve repair in patients who have FTR with a minimum of moderate     tricuspid regurgitation.   "
54316|NCT02574637|"     A Phase 2b study to evaluate the efficacy and safety of MEDI2070 in Subjects with Moderate to     Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti Tumor Necrosis Factor-Alpha     Therapy   "
54317|NCT02574624|"     To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) & to identify     and document with video evidence and surgeon's case report forms intraocular maneuvers that     are facilitated by VISIA.   "
54319|NCT02574598|"     This is a phase II open-label randomized clinical trial of MK-3475 (Pembrolizumab) on     previously treated PDL1 positive non-small cell lung cancer (NSCLC) patients . This drug has     shown to allow partial response according to the immune-related response criteria and the     response evaluation criteria in solid tumors (RECIST). The main endpoint is to compare the     overall response rate (ORR) of MK-3475 with docetaxel or docetaxel alone in patients with     advanced NSCLC.   "
54320|NCT02574585|"     The purpose of this study is to analyze the safety and efficacy of autologous bone marrow     mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete     spinal cord injury.   "
54323|NCT02574546|"     This research is being done to learn more about the risk of developing breast cancer by     studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to     study cells, genes, and gene products to help us to learn how to detect cancer in its     earliest stages, and if this information may differ in patients with different ethnic     backgrounds.   "
54324|NCT02574533|"     This is an open label Pilot study to evaluate the combination of Vigil™ and pembrolizumab in     patients with incurable locally advanced or metastatic melanoma. Patients undergoing a     standard of care surgical procedure (e.g., tumor biopsy, palliative resection) and meeting     procurement eligibility criteria may have tumor harvested for Vigil™ vaccine manufacture.     This study evaluates the hypothesis that vaccination with Vigil™ will induce cancer-specific     T cell immunity in these patients. Addition of pembrolizumab to Vigil™ treated patients will     further augment these immune changes on sequential biopsy when comparing post-Vigil™ but     pre-PD-1 inhibitor to post-PD-1 inhibitor biopsies, and the combination therapy will be     associated with reduction of tumor volume on clinical exam and/or imaging.   "
54325|NCT02574520|"     This is a research study of SABER® -Bupivacaine, an experimental medication designed to     relieve pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery,     SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound.      The purpose of this study is to measure how well it works in reducing pain after laparoscopic     cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of     SABER®-Bupivacaine (its side effects).   "
54326|NCT02574507|"     The objective of the study is to develop and test the feasibility, acceptability, and initial     efficacy of a novel couples-based behavioral weight and symptom management intervention for     obese breast cancer survivors and their partners. The proposed project consists of two     phases. Phase I will include intervention development and refinement. Intervention     development will be guided by the research team's prior work, the interdependence model of     communal coping and behavior change, and information obtained from couples participating in     focus groups. The intervention protocol will then be tested with 5 couples to assist with     refinement of intervention content. During phase II, the feasibility, acceptability and     initial efficacy of the intervention will be examined. Obese breast cancer survivors in the     first year following treatment and their overweight or obese partners will receive 6 weekly     and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The     intervention will be provided in a couples-based format where each couple will meet     separately with the therapist. Couples will be assessed at pre-, post-, and 3-months     post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress),     eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e.,     insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer     survivors and their partners. It is hypothesized that the intervention will be feasible     (i.e., completed sessions), and participants will find the intervention acceptable as     assessed by a measure of treatment acceptability. It is also hypothesized that participants     will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress),     eating behavior, and physical activity, and their change in weight will covary with change in     symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that     participants with greater weight loss will evidence improved functioning in insulin, IL-6,     IL-8, TNF-α, adiponectin, and heart rate.   "
54327|NCT02574494|"     The primary aim is to establish whether breastfeeding is associated with lowering blood     pressure in hypertensive women.   "
54328|NCT02574481|"     The primary objective of this trial is to evaluate the safety and effectiveness of the Boston     Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for     treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up     to 140 mm in length.      Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific     Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating     Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤     190 mm in length.   "
54329|NCT02574468|"     Abstract Aim The aim of this randomized clinical trial was to histologically investigate     possible effects of dexamethasone application on pulp tissue healing during one step mineral     trioxide aggregate (MTA)-direct pulp capping (DPC) and miniature pulpotomy (MP) in healthy     human premolar teeth.      Methodology Forty intact premolar teeth of 10 orthodontic patients, scheduled for extraction,     were randomized for DPC (n=20) or MP (n=20). A high speed bur under copious water coolant was     used for mechanical exposing of buccal pulp horn site. Prior to sealing with white ProRoot     MTA, 10 out of twenty pulpal wounds of each group were randomly received dexamethasone.     Cavities were restored with glass ionomer. Teeth vitality was evaluated in 7, 21, 42, and 60     day follow-ups. Signs and/or symptoms of irreversible pulpitis or pulp necrosis were     considered as failure. After 60 days, the teeth were extracted and submitted for histological     examination. Kruskal-Wallis and Fisher exact tests were used for statistical analysis of the     data (P=0.05).      HTTP://www.accessdata.fda.gov/scripts/cred/drugsatfda   "
54330|NCT02574455|"     This is an international, multi-center, open-label, randomized, Phase III study in patients     with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including     a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1     to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs     to be selected prior to randomization from one of the 4 allowed regimens. Randomization will     be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and     geographical location (North America vs Europe).      Patients will be treated until progression, unacceptable toxicity, study withdrawal, or     death, whichever comes first. Tumor progression leading to treatment withdrawal will be     assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC,     CT scans (or MRI if contrast allergic) will be obtained at least every 8 weeks until the     occurrence of progression of disease requiring discontinuation of further treatment.All     patients, including those prematurely terminating study participation, will be followed every     4 weeks during the first year and every 8 weeks thereafter for survival follow-up.   "
54331|NCT02574442|"     The goal of this proposal is to determine whether a hand-held confocal microscopy probe may     perform better than standard methods in detecting cancer or pre-cancerous abnormalities of     the cervix. The confocal probe will provide invivo histopathology-like images of cell     morphology and three-dimensional tissue architecture non-invasively in real time.   "
54332|NCT02574429|"     Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)     commonly co-occur, few studies have examined PTSD treatment among individuals with BPD.     Additionally, many PTSD research studies exclude individuals with BPD due to their complexity     and concerns regarding risk. This study aims to investigate the effectiveness of     Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals     with these co-occurring disorders following completion of a Dialectical Behavioural Therapy     Program (an evidenced-based treatment for BPD). The investigators are using a repeated     measures pre and post design. Data will be collected prior to participants starting the CPT     group, throughout the duration of the CPT group (i.e., weekly), and following the completion     of the CPT group.   "
54333|NCT02574416|"     Although increasing age is associated with declining health and function, there are wide     variations between individuals in the ageing process. Some of these differences are explained     by differences in lifestyle, but little is known about the determinants of lifestyle in older     age. The proposed project will describe influences on health behaviour and lifestyle in older     adults. Investigators will undertake a prospective study of community-dwelling older people     who use any of the Medicine for Older People Services in Southampton, allowing us to gain     obtain important insights into the relationship between health behaviour, lifestyle and     health outcomes in older people. Our principal aim is to identify key points on the ageing     pathway when interventions may be best targeted to promote health. The findings of this     project will underpin the design for a complex intervention to be conducted in the future to     improve the health outcomes of older people.   "
54352|NCT02574169|"     This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral     injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.   "
54334|NCT02574403|"     Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults.     It is characterized by the occlusion of intrarenal vessels due to the presence of     platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The     discovery of complement alternative pathway as a major risk factor for aHUS has led to the     design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab.     Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS     patients with a dramatic decrease in the risk of end-stage renal disease. However, the     optimal duration of eculizumab therapy is still debated. The present study aims to assess the     feasibility and safety of the discontinuation of eculizumab treatment in children and adults     with aHUS.   "
54335|NCT02574390|"     Creation of a large repository of induced pluripotent stem cells (iPSC), bio-fluid samples     (blood and spinal fluid (optional)), and cell lines for ALS gene identification. This will be     combined carefully with collected measures of the pattern of the symptoms people with ALS     have and how these change over time. People with other motor neuron diseases and healthy     controls will be included as comparisons   "
54336|NCT02574377|"     This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC     vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.   "
54337|NCT02574364|"     The traditional open appendectomy in the clinical effect is not prefect, and for a long time     there is no measurable improvement. The application of abdomen CT before surgery provides a     new approach to the incision and new perception.      In a randomized controlled trial of modified incision versus traditional incision. Length of     hospital day was the primary terminus, while operating time, postoperative complication, scar     and time to resume normal activity and work as secondary terminus.   "
54338|NCT02574351|"     To study whether the immune response as directed by regulatory T cells is different between     obese asthmatics, normal weight asthmatics and healthy controls.   "
54339|NCT02574338|"     The aim of this study is to compare the effectiveness and safety of Foley's catheter and     misoprostol in cervical ripening.   "
54340|NCT02574325|"     Primary objective To investigate the effect of a 24-week, twice daily dosing regimen of     ARI-3037MO compared to placebo on plasma triglyceride (TG) levels, liver enzymes and hepatic     fat content in patients with dysglycemia and hepatic steatosis due to nonalcoholic fatty     liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Secondary Objective To     investigate the safety and tolerability of a 24-week, twice daily dosing regimen of     ARI-3037MO compared to placebo in patients with dysglycemia and evidence of NAFLD or NASH.   "
54341|NCT02574312|"     This post-marketing investigation will evaluate the mechanical axis alignment achieved with     the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment     achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee     Arthroplasty.   "
54342|NCT02574299|"     The ability to encode the speech signal is determined by ascending and descending auditory     processing. Difficulties in processing these speech signals are well described at the     behavioral level in a specific language disorder. However, little is known about the     underlying pathophysiological mechanisms. The assumption is that we should observe a     degradation of the signal provided by the ear in the deaf subject while in case of specific     language impairment it would be a phonemic disorder (possibly linked to a processing disorder     auditory). The two population groups should therefore have different abnormalities of their     central auditory process - which could be modified by the target remediation for each group.   "
54343|NCT02574286|"     To evaluate the effect of VPRIV® therapy on patients with type 1 Gaucher disease by measuring     the change in the lumbar spine (LS) and bone mineral density (BMD) after 24 months of     treatment.   "
54344|NCT02574273|"     Several independent evaluations have supported the effectiveness of the Secret Agent Society     (SAS) Program in improving the social-emotional functioning of children with Autism Spectrum     Disorders (ASD) in clinic- (Beaumont & Sofronoff, 2008; Tan, Mazzucchelli & Beaumont,     submitted), school-(Beaumont, Rotolone & Sofronoff, in press; Einfeld et al., submitted) and     remote Skype/telephone-assisted delivery contexts (Sofronoff, Silva & Beaumont, in press).The     present study aims to extend on the above literature by conducting a 6-month randomized     controlled trial evaluating the effectiveness, utility and acceptability (including cultural     acceptability) of the Secret Agent Society (SAS) social-emotional skills training program.     Specifically, the study aims to evaluate the effectiveness of the SAS Program for 8-12     year-old children with social difficulties in the context of a range of diagnosed mental     health conditions and/or developmental disorders, including anxiety disorders, ADHD, and     Autism Spectrum Disorder.   "
54345|NCT02574260|"     The primary objective of this extension study was to further assess the safety and     tolerability of talimogene laherparepvec. Secondary objectives were to assess objective tumor     response rate and survival.   "
54346|NCT02574247|"     The purpose of this study is to determine how changes in speech perception resulting from a     computerized auditory training program are related to concurrent changes in auditory     brainstem function resulting from the training. It is hypothesized that the degree of     improvement in speech perception will be correlated with the degree of change in brainstem     function.   "
54347|NCT02574234|"     No successful strategy is proposed to patients submitted to important surgery to reduce the     incidence of postoperative cognitive disorders (POCD) onset. This project propose to measure     plasma levels of apelin in wide population submitted to orthopedic surgery. Apelin could be     involved in anti-inflammatory processes. Apelin levels before and after surgery correlated to     postoperative cognitive disorders symptom measured by PET-Scan could be an important     predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative     cognitive disorders.   "
54348|NCT02574221|"     This study is to evaluate the sensitivity of the molecular method and its ability to split a     stannous fluoride toothpaste versus a negative control.   "
54349|NCT02574208|"     CDC recommends universal HIV testing in all adults, at least once during life, to reduce the     pool of infected patients unaware of their status. Routine universal HIV testing can use     classical ELISA tests from serum, or rapid tests, ideally from finger-stick whole blood     (FSB), which have shown close predictive values from classical tests. The investigators will     compare the acceptability and feasibility of the two methods.   "
54356|NCT02574117|"     Maxillary expansion was performed for adult female patients suffering from maxillary     constriction with bilateral posterior cross-bite using fixed Quad-helix appliance, for about     8 months. The appliance was delivered and activated at the day of corticotomy and bone graft.     The activation was made half-molar unit each side. The patient was scheduled each month to     activate the appliance or reactivate if needed. Corticotomy was performed at area of     maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was     performed, before appliance activation and corticotomy, at the end of expansion (8 months)     and after finishing orthodontic treatment (average 2.5 years from start of treatment).   "
54357|NCT02574104|"     Complex service interventions are neither smooth nor easy in any transitioning healthcare     facility. Simulations performed in the new environment reinforce patient safety by uncovering     safety threats, enabling their correction, and orienting hospital staff. This study expands     upon patient safety successes at several institutions to measurably enhance patient safety at     upcoming new inpatient facilities.   "
54358|NCT02574091|"     This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib     Hydrochloride Cream in healthy adults and patients with mild to moderate psoriasis.   "
54360|NCT02574065|"     Infant colic is a common condition characterized by excessive crying. The otherwise healthy     infant aged less than 3 months is difficult to console during the periods with crying. The     condition is defined by modified Wessel's criteria i.e. crying for more than 3 hours of the     day, for more than 3 days of the week for at least 1 week.      The description of infant colic hasalso been defined by Rome III diagnostic criteria     andincludes infants from birth to 4 months of age,without failure to thrive, that are showing     paroxysms of irritability, fussing or crying that starts and stops without obvious cause. The     episodes last 3 or more hours/day and occur at least 3days/week for at least one week. The     infant has no signs of central nervous system or intrinsic developmental difficulties, is     normal on physical examination, and has normal growth patterns.      Although infant colic is considered to be self limiting it is a distressing problem for     families. It is in fact one of the most common reasons why parents seek the advice of a     paediatrician or family practitioner during their child's first 3 months of life Up to 20% of     infants under three months are affected by infant colic.      Infant colic could have significant adverse effects on family quality of life and could even     be a trigger for shaken baby syndrome. Parental perception associated with colicky complaints     is therefor strongly recommended to be an outcome measure in trials of infantile colic.      Measurement of parental/family quality of life and parental perception of colic severity with     the help of a Visual Analogue Scale (VAS) in a Polish study showed that the use of a     probiotic, Lactobacillus reuteri DSM 17938, could improve the perceived problems.      The relationship between infant colic and gastroenterological, allergical and psychological     disorders later in childhood was studied in a prospective study on 96 infants divided into     two groups, colicky and non-colicky. The children diagnosed with infant colic, showed an     increased susceptibility to recurrent abdominal pain, allergic and psychological disorders in     childhood when they were 10 years old.      The aetiology of infantile colic seems to be multifactorialbut is,despite many years of     research, still unknown. The intestinal microbiota differs between infants with and without     colic and has therefore been suggested to have a potential role. Other possible explanations     are for example gut motility disturbances, low-grade mucosal inflammation and visceral     hypersensitivity.      Evidence suggests thatadministration of the probioticL. reuteri DSM 17938 might offer some     benefit.L. reuteri DSM 17938 has been tested for its effect on crying in colicky infants and     has been demonstrated to have a significantly favourable effect on crying time in fivetrials.     One is a randomized trial that compared the probioticto Simethicone; three areplacebo     controlled randomized double blind trials and yet another is a placebo controlled randomized,     single blind, observational study. A fifth studydid not find any effect.      Combining the results in a meta-analysis from three double blind, placebo controlled     randomized trials (published at the time of the analysis, including the neutral one) found     that, compared with placebo, L. reuteri administration reduced crying time at day 21 with     about 40 min.      Recently it has been documented in a clinical trial that prophylactic use of L. reuteriDSM     17938during the first three months of lifereduced the onset offunctional gastrointestinal     disorders, particularly functional constipation, regurgitation and infantile colic.      In conclusion, the administration L. reuteri DSM 17938 may reduce the crying time in children     with infantile colic, especially those fed predominantly or exclusively with breast milk.     However, further randomized controlled studies, are required to be able develop     recommendations in the management of infant colic.      The present trial is undertaken to further document the effect of L. reuteri DSM 17938 on     crying in colicky infants.   "
54361|NCT02574052|"     The purpose of this study is to evaluate whether exposure to nutrition information with or     without nutrition education would influence college students' dietary choices and improved     the previous photographs-based dietary assessment tools.   "
54362|NCT02574039|"     A diet rich in whole grain is inversely associated with cardiovascular disease risk and this     benefit could be partly attributed to the phenolic acid content of whole grains. The exact     absorption, metabolism and excretion of whole grain phenolic acids, however, is not fully     understood. In a small human intervention trial, the investigators will investigate to what     extent phenolic acids from whole grain oats are absorbed, excreted in urine and how they are     metabolised.   "
54363|NCT02574026|"     The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal     volunteers by tapping the finger .   "
54364|NCT02574013|"     To achieve an adequate visual working field during laparoscopic colorectal surgery without     disturbance of the small intestine, patients are positioned in Trendelenburg position. This     position results in hemodynamic changes which may increase the risk of cardiopulmonary     complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was     introduced as alternative for the Trendelenburg position during laparoscopic surgery.   "
54365|NCT02574000|"     This is an observational study to address the following questions.        1. How many people develop stroke-shoulder pain within 3 days of stroke?        2. How many people have stroke shoulder pain at 8-10 weeks after stroke?        3. Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of          having stroke-shoulder pain at 8-10 weeks?        4. What are the best bedside examination tests to identify stroke-shoulder pain?   "
54366|NCT02573987|"     detremine if efficiency of MEOPA anesthesy is at least equivalent to local anesthtics into     the chorionic villus sampling in the first trimester of pregnancy   "
54367|NCT02573974|"     Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the     energy balance that leads to a gradual mobilization of energy reserves in the body and to     increasing deterioration of the nutritional status of patients. This will thus significantly     reduce quality of life and survival of patients with a lower tolerance to cancer treatments.     Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or     not explored, which could explain that there is still no satisfactory therapeutic solution to     halt the gradual deterioration of the nutritional status of patients. In this sense, apart     from preclinical data obtained in animal models, there is currently no clinical study on the     functioning of skeletal muscle energy metabolism in undernourished patients suffering of     cancer.   "
54368|NCT02573961|"     The purpose of this study is to compare the effects of laser acupuncture and high protein low     carbohydrate diet on the treatment of obesity and lowering of endothelial markers.   "
54369|NCT02573948|"     This study aims at assessing the feasibility of implementing an interventional cohort of     people who inject drugs in Haiphong, Viet Nam.      For this purpose, the investigators will conduct a RDS survey to i) assess the current     situation of drug use behaviour, HIV and Hepatitis C Virus (HCV) infection in the study     population and ii) recruit participants for the longitudinal phase. The latter will consist     of enroling the most difficult to reach People Who Inject Drugs (PWID) (those not followed by     health centers), including early injectors, Men who have Sex with Men (MSM) and female sex     workers (FSW) and following them up for 6 months in order to estimate the follow-up rate and     preliminary estimates of HIV and HCV incidence.   "
54370|NCT02573935|"     This study evaluates the potential synergic anti-myeloma activity of clarithromycin when     combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.   "
54371|NCT02573922|"     In the present study, the primary aim was to evaluate if oxycodone-naloxone combination     compared to oxycodone reduced opioid induced constipation in patients with or without chronic     opioid treatment undergoing spine surgery.   "
54372|NCT02573909|"     There are conflicting results in earlier studies concerning the safety and efficacy of     epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as     effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In     another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment     with double dose compared to epidural morphine. In our previous study, epidural oxycodone     provided safe and effective pain relief when compared to intravenous oxycodone.      In the present study, the aim was to compare the efficacy and safety of epidural or     intravenous oxycodone in patients undergoing elective gynecological surgery with planned     epidural pain treatment.   "
55807|NCT02555150|"     The purpose of this randomized, double-blind, crossover study is to compare two long-acting     stimulant formulations—once-daily PRC-063 and once-daily lisdexamfetamine (LDX)—through a     15-hour period on driving performance, as measured with a driving simulator, in adult     patients with ADHD.   "
54373|NCT02573896|"     This NANT trial will determine the maximum tolerated dose (MTD) of autologous expanded     natural killer (NK) cells when combined with standard dosing of ch14.18 and will assess the     feasibility of adding lenalidomide at the recommended Phase II dose of the expanded NK cells     with ch14.18, for treatment of children with refractory or recurrent neuroblastoma.   "
54374|NCT02573883|"     This study is being done to compare the effects, good and bad, of fractionated CO2 laser     treatment and clobetasol proprionate .05% ointment on vulvar lichen sclerosus.   "
54375|NCT02573870|"     Batefenterol inhalation powder is currently under development as a fixed-dose combination     with fluticasone furoate (FF) for the treatment of Chronic Obstructive Pulmonary Disease     (COPD).      The present study will administer batefenterol/FF (300/100 micrograms [mcg]) for the first     time to subjects with COPD, to investigate the safety and tolerability of the combination     compared with placebo, and to evaluate the pharmacokinetics and pharmacodynamics profiles of     the individual components when administered in combination.      This is a Phase IIa, multicenter, randomized, placebo-controlled, double-blind, parallel     group study. Subjects will be randomized (2:1) to one of the following double-blind treatment     groups:      Batefenterol/FF 300/100 mcg inhalation powder once daily, or matching placebo inhalation     powder once daily.      Subjects will self-administer the study treatments once daily (QD) in the morning for 42 days     via a multi-dose dry powder inhaler (DPI) which contains two blister strips. Additionally, an     inhaled short acting beta2-receptor agonist, albuterol will be provided from screening to the     end of the treatment period for all subjects to use as needed to relieve COPD symptoms. At     the end of the treatment period, subjects can resume conventional therapy.      The study will randomize approximately 60 subjects. The total duration of subject     participation (from screening to follow-up) will be approximately 8 weeks.   "
54376|NCT02573857|"     Part A      -Cohort 1 DSM265 will be administered as a single dose (400 mg). For cohort 1 only, an     additional single dose (400 mg) of DSM265 may be given if gametocytemia develops. Treatment     with DSM265 will be given after an overnight fasting period of ≥ 8 hours. If dosing is to     occur in the evening, subjects will be required to fast for ≥4 hours prior to receiving     treatment. Subjects will be required to fast for a further four hours anytime after dosing     with DSM265.      Part B        -  Cohort 2 OZ439 will be administered as a single 200 mg dose. If recrudescence is          observed, a single 400 mg dose of OZ439 will be given. Treatment with OZ439 will be          administered after an overnight fasting period of ≥ 6 hours. If dosing is to occur in          the evening, subjects will be required to fast for ≥4 hours prior to receiving          treatment. Participants will drink 200 mL of milk prior to drug administration, and then          swallow the appropriate volume of OZ439 suspension. Subjects will be required to fast          for a further six hours anytime after dosing with OZ439.        -  Cohort 3 DSM265 will be administered as a single dose (400 mg) as described for cohort          1. No additional dose will be administered.   "
54377|NCT02573844|"     The purpose of this study is to determine whether Proklama is effective in significative     reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS     disease.   "
54378|NCT02573831|"     Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental     or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor     pain in the early phase. The aim of the randomised, double blinded, placebo controlled study     was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of     oxycodone and the effects to the newborn.   "
54379|NCT02573818|"     The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms     during esophagogastroduodenoscopy (EGD) or colonoscopy.   "
54380|NCT02573805|"     The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile     tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.   "
54381|NCT02573792|"     Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the     central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's     neuromyelitis optica (NMO) or a systemic disease.      The optical coherence tomography (OCT) is a retinal imaging technique to measure the     thickness of the retina and its different layers with an accuracy of 4-6 µM.      Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to     6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve     fiber layer (RNFL).      The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed     by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and     the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.      The diagnosis and prognosis value of the OCT in patients with ON is not well known   "
54382|NCT02573779|"     A study to compare growth, development of the intestinal bacterial environment, and other     short term outcomes in groups of babies fed primarily their own mother's milk compared to     those who receive primarily donor human milk. The investigators hypothesize that infants who     receive primarily their own mother's milk will have better growth, a more diverse intestinal     bacterial environment, and possibly some improved short term outcomes such as better feeding     tolerance and lower rates of infection.   "
54454|NCT02572843|"     The objective of the trial is to demonstrate that the addition of neoadjuvant and adjuvant     immunotherapy (with the anti-PD-L1 antibody MEDI4736) to standard neoadjuvant chemotherapy     (with cisplatin/docetaxel) in primary resectable stage IIIA(N2) NSCLC is efficacious and     feasible.   "
54383|NCT02573766|"     The goal of this clinical research study is to learn if using a type of non-invasive therapy     called neurofeedback training can help teach patients with peripheral neuropathy how to     change their own brain waves to lower their perception of neuropathy and help improve their     overall quality of life.      Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a     computer software program to measure brain wave activity.   "
54384|NCT02573753|"     The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic     reflector of both healthy and disease states, altering in response to changes in the     environment. This may precede clinically detectable disease; and thereby, could be used to     predict disease onset and additionally monitor response to treatment and predict prognosis.     The overall hypothesis of this pilot study is that the human microbial communities are     influenced by sleep and altered in humans with abnormal sleep patterns, and they may     ultimately relate to disease risk.   "
54385|NCT02573740|"     This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose     study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive     Impairment (MCI) due to AD.   "
54386|NCT02573727|"     Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin     Response will assessed at every 48 hour (i) Complete response: Decrease in serum creatinine     to 133 lmol/L (1.5 mg/dL). (ii) Partial response: 50% serum creatinine decrease from baseline     to a final value >133 lmol/L (>1.5 mg/dL).      (iii) No response: Serum creatinine decrease of < 50% from baseline      Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or     for a maximum of 7 days after rescue treatment will be followed.      If intolerant to terlipressin, excluded from study and rescue treatment will be given in form     of noradrenaline or octreotide and midodrine.   "
54387|NCT02573714|"     The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a     safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises     in resource-limited settings.   "
54388|NCT02573701|"     The purpose of this study was to evaluate the applicability and usefulness of the guideline     treatment for diagnosis and treatment of adolescents with schizophrenia, also to evaluate the     compliance to the treatment according to the guidelines, and to compare the treatment     compliance, severity of illness and social functioning of patients treated according to     guideline treatment vs patients with the treatment as usual on a six month follow up.   "
54389|NCT02573688|"     The aim of the research study will be assess the effectiveness of a long-term     interdisciplinary lifestyle in many aspects including food intake, psychological symptoms,     physical activity habits, energy expenditure, body composition and anthropometric     measurements in adults obese.   "
54390|NCT02573675|"     In this study, the recent trends in outcomes according to the dialysis modality in Korea     since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or     high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic     burden according to the dialysis modality will be investigated retrospectively using the     Korean Health Insurance Review and Assessment Service (HIRA) database.   "
54391|NCT02573662|"     Introduction This study evaluates the effect on glucose, lipid and bone metabolism following     knee orthopedic procedures in healthy and physically active individuals. The sedentary     rehabilitation period following these procedures may impact negatively on glucose, lipid and     bone metabolic pathways, whereas the more physically active rehabilitation period instituted     6 weeks after surgery is hypothesized to impact positively.      Perspective This study will establish whether the well-known effects on glucose, lipid and     bone metabolism of a sedentary lifestyle can be observed already following 6 weeks of     physical inactivity in otherwise healthy and physically fit young and middle aged     individuals. Investigators will thereby add knowledge to previous findings following strict     bed-rest in healthy individuals on glucose, lipid and bone metabolism. In a clinical     perspective it is important to examine the extent to which healthy individuals deteriorate in     various metabolic pathways to better understand the pathophysiology behind these defects both     in healthy individuals and in patients, who undergo bed rest or an equal reduction in     physical activity as part of their rehabilitation.      Study design 16 physical active non-diabetic individuals of age 18 - 50 years who are     undergoing knee surgical procedures at the Arthroscopic Center at Amager/Hvidovre Hospitals     are recruited as cases for this case-control study.      10 non-diabetic control subjects matched for age, gender and physical activity are recruited     to establish a reference level.        -  The individuals will bring in morning spot urine for measurement of soluble urokinase          plasminogen activating receptor (suPAR), creatinine, albumin and orosomucoid. Weight and          height and waist and hip circumference will be measured.        -  Oral glucose tolerance test (OGTT) with ingestion of 75 g glucose during 5 min from          baseline (0 min). Plasma for glucose, insulin, C-peptide, non-esterified fatty acid          (NEFA) will be drawn        -  Before OGTT blood will be drawn for measurement of HbA1c, total cholesterol, LDL, HDL,          triglyceride, Na, K, creatinine, hemoglobin (HgB), C-reactive protein (CRP), leukocytes,          alanintransaminase (ALAT), alkaline phosphatase, Ca++, D vitamin, TSH, bone turnover          markers (BTM), suPAR, interleukin 6 (IL6), TNFa, high-sensitivity C-reactive protein          (hsCRP), lipid density profiling and lipid particle size.        -  Dual energy X-ray absorptiometry (DXA) of hip, lumbar columna, visceral and subcutaneous          fat is measured by Hologic Discovery scanner.   "
54392|NCT02573649|"     Multicentre, prospective, double blinded, randomized study designed as an intrapatient     comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on     prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up     tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory     vasovagal syncope.   "
54393|NCT02573636|"     The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and     PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after     biochemical failure.   "
54394|NCT02573623|"     Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific     symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low     sensitivity of available diagnostic tools.      This project aims at evaluating two innovative immunological methods for diagnosing of active     TB among HIV-infected and uninfected children.   "
54395|NCT02573610|"     The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to     that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for     perioperative bacteria eradication in patients who are scheduled for cataract surgery.   "
54396|NCT02573597|"     Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine     the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous     Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB     efficacy advantage.   "
55611|NCT02557724|"     To study if the administration of corticoid hinder or enhance the mobilization of Mesenchymal     Stem Cells (MSCs) in the peripheral blood during liver transplantation and whether this     affects the outcome with respect to graft versus host response.   "
54397|NCT02573584|"     The vascular fingerprint is a simple selection tool to identify testicular cancer patients     with a high risk of arterial cardiovascular events during and in the first year after     cisplatin chemotherapy. Eventually, this selection method allows a relative small randomized     intervention study with i.e. LMWH during chemotherapy to prove the effectiveness and safety     in lowering the chance of an arterial cardiovascular event.   "
54398|NCT02573571|"     To develop a score that can predict early from diagnosis of Clostridium difficile infection     (CDI) the risk for relapse and of unfavorable outcome. This score can be used in the future     to identify patients will benefit from fidaxomicin treatment.   "
54399|NCT02573558|"     Delirium are common after orthopedic surgery in the elderly and are directly associated with     loss of independence, reduction in the quality of life and increased mortality. The cause of     postoperative delirium still remains unclear and may be multifactorial. The aim of this     retrospective study is to examine prevalence of postoperative delirium according to the use     of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under     regional anesthesia.   "
55105|NCT02564341|"     The TEACH randomized controlled trial will test the effectiveness of a collaborative care     intervention directed towards physicians who provide care for HIV-infected persons to improve     the quality of care for prescribing chronic opioid therapy (COT) for pain and reduce the     misuse of prescription opioids among HIV-infected persons.   "
54400|NCT02573545|"     To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software,     compared to the current method, when planning and inserting the needle under MRI monitoring     in the context of liver biopsies enable:        -  a facilitation of the planning stages of the procedure (route path, marking of the entry          point and alignment of the MRI cutaways on the planned path), resulting in a reduction          in the duration of the planning stages,        -  a facilitation of the real-time modification of MRI cutaways during the procedure,          resulting in a reduction of the duration of the procedure   "
54401|NCT02573532|"     This observational study includes patients undergoing major non-cardiac surgery, and screens     them for the occurence of perioperative myocardial injuries (PMI). Incidence, patient     characteristics, pathophysiology, and 1-year outcomes of PMI will be described.   "
54402|NCT02573519|"     Gastrointestinal (GI) symptoms including vomiting, nausea, abdominal pain, constipation or     chronic diarrhea affect a large number of patients with diabetes mellitus (DM). Furthermore,     abnormal GI transit times restrict correct dosing of medication. Two new methods, in     combination only available at Aarhus University Hospital (AUH), allow examination of human     whole-gut function with a high degree of detail:      PET-scans (positron emission tomography scans) of cholinergic signaling in the bowel wall The     most important nerve fibers stimulating GI peristalsis use acetylcholine as neurotransmitter.     The novel PET technique, [11C] Donepezil PET/CT (Donepezil PET/CT scan based on a carbon     isotope), developed at AUH, allows in vivo quantification of cholinergic cells within the     bowel wall.      3D-Transit With 3D-Transit electromagnetic capsules are followed during their passage through     the GI tract. The novel method provides highly detailed information about regional and     whole-gut passage times and contractility patterns.      Study protocol 20 healthy subjects and 25 diabetic patients with severe GI symptoms will be     included.        1. With [11C]donepezil PET/CT, we aim to describe the degree of cholinergic denervation of          the intestine in DM patients with GI severe symptoms.        2. Using 3D-Transit in DM patients before and during intervention with acetyl          cholinesterase inhibitor we aim to determine how cholinergic denervation of the          intestine contributes to abnormal GI transit patterns.        3. Comparing the transit times of DM patients with either vomiting or diarrhea as main          symptoms, we aim to provide pilot data on phenotypes of diabetic GI dysfunction.        4. We aim to explore various aspects of pan-enteric dysfunction in DM, including          prolonged gastric emptying secondary to severe constipation and delayed small intestinal          transit in patients with symptoms of gastroparesis with or without delayed gastric          emptying      Perspectives Detailed information about cholinergic denervation in DM and objective     classification of the pathophysiology of diabetic GI dysfunction may allow targeted future     treatment of individual patients.   "
54403|NCT02573506|"     This Phase II randomized study is to determine the efficacy of consolidation chemotherapy     after split irradiation with concurrent chemotherapy in locally advanced none-small cell lung     cancer patients with bulky tumor.   "
54404|NCT02573493|"     In this trial, the objectives are to determine the efficacy and toxicity of induction     chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2:     A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and     5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of     nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the     frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in     this cancer.   "
54405|NCT02573480|"     This study is an optimization study to evaluate how a wraparound program for youth who have     been injured by violence helps to change violence related attitudes and beliefs, change     individual risk factors for violence and reduce the risk of future injury due to violence.     Wraparound care involves linking the youth with a support worker who will work with the youth     to develop positive support networks and help them link with services that address risk     factors towards future violence.   "
54406|NCT02573467|"     This extension study will provide data to further evaluate the efficacy, safety, and     tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in     patients with sporadic inclusion body myositis. Patients who complete the core study and     qualify for this extension study will enter Treatment Period 1, during which they will     continue on the study drug which they were receiving in the core study (either one of the     three BYM338 doses or placebo). Treatment Period 1 will continue until the dose of BYM338     with the best benefit-risk profile is determined and selected. The duration of Treatment     Period 1 could be up to one year (but estimated to be between 6 and 8 months) and the total     duration of Treatment Period 1 will depend upon the timing of selection of the dose for     Treatment Period 2. Once the dose with the best benefit-risk profile is selected, all ongoing     subjects (including those who have been receiving placebo) will enter Treatment Period 2 and     will be switched to open-label treatment with BYM338 at the selected dose. Treatment Period 2     will continue until BYM338 is approved and commercially available in the country of the     investigational site.   "
54407|NCT02573454|"     The purpose of this study is to determine whether prosocial exercise (exercising for the     benefit of others) results in greater well-being and physical activity when compared to     personal exercise (exercising without attempting to benefit others). Participants will be     randomly assigned to utilize one of two exercise apps for a two week period: Charity Miles,     which allows users to donate money to charities based on exercise participation, or Nike+     Running, which is a standard GPS exercise app. Participants will be provided with     questionnaires at pre- and post-test, at a 4 week-follow-up, and immediately before and after     each use of the app.   "
54408|NCT02573441|"     The study will examine whether school liaison services and home-based parental tutoring can     help with academic difficulties of paediatric brain tumour survivors who received cranial     spinal radiation and have returned to school. Forty-five patients will participate in the     project. All patients will receive psychology liaison services to link resources at the     hospital with those in the community. Patients will participate in one of two tutoring     programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone     calls will be used to support parents using the program. Patients will be tested before,     immediately after, and six months following each tutoring program to assess growth in     mathematics and working memory abilities.   "
54420|NCT02573285|"     The objective of this multi-center, non-randomized, prospective pilot study is to examine the     rate of successful primary spontaneous pneumothorax (PSP) resolution using the simple     aspiration technique.      In this study, eligible subjects diagnosed with PSP at eleven participating large children's     hospitals (members of the Midwest Pediatric Surgical Clinical Research Consortium) will be     enrolled and offered a choice of management with either the simple aspiration protocol or     management according to their surgeon's preference, which may include simple aspiration,     chest tube placement, or rarely, an operation.   "
54421|NCT02573272|"     Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on     cardiovascular risk factors measured by biochemical and ultrasound parameters compared with     enzyme-inducing AEDs.   "
54409|NCT02573428|"     The primary purpose of the present study is to evaluate the diagnostic validity of eye     tracking measurements acquired during viewing of socially-relevant stimuli in predicting ASD     diagnosis. The secondary purpose was to explore the potential prognostic value of eye     tracking measures through cross-sectional associations with non-verbal cognitive ability.      Deficits in eye gaze are a hallmark sign of autism. A large and growing body of research     supports the ability of eye-tracking based measurements to sensitively discriminate     individuals with ASD and healthy participants. These investigations have identified that the     core deficit in autism as disruption of social attention, reflecting an inability to     appropriately engage and track socially- and emotionally-relevant aspects of the visual     world. Thus, eye gaze tracking, acquired during viewing of socially-relevant stimuli, may be     a useful approach to identifying objective markers of ASD. Eye tracking also carries the     advantages of being less intrusive and expensive than MRI and genetic testing and     specifically focuses on the core neurobehavioral characteristics of ASD - abnormalities in     social attention.      After diagnosis of ASD, key clinical tasks in young children involve determining an accurate     prognosis and tracking the progress of early interventions. Currently, the only prognostic     indicators are clinical observations (subjective and expensive) and non-verbal cognitive     ability testing (difficult to acquire, time-consuming, unavailable in many settings).     Recently, eye gaze tracking was found to predict functional outcomes. Thus, in addition to     being an objective marker for ASD, eye tracking measurements have potential to be useful for     predicting cognitive and functional outcomes. Similarly, the only available methods for     tracking treatment progress are parental reports (highly subjective), clinical observations     (subjective and expensive), and cognitive measurements (expensive and unavailable in many     settings. This study will evaluate, using cross-section data, the potential for eye tracking     data to serve as a proxy for non-verbal cognitive ability scores in determining prognosis for     ASD-affected children. Additionally, this study will evaluate the test re-test reliability of     eye tracking parameters that can potentially be used to track treatment progress.   "
54410|NCT02573415|"     This feasibility study aims to enroll ten subjects who will undergo deceased donor uterine     transplantation at Cleveland Clinic. We estimate that fifty to one hundred patients with     uterine factor infertility will need to be screened to identify 10 appropriate subjects.      There are seven phases involved in this study: Primary and Secondary Screening, Medical     Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up   "
54411|NCT02573402|"     The purpose of this research study is to evaluate the effects upon the bladder of electric     stimulation of the leg's tibial nerve in people with acute spinal cord injury with an     intervention called transcutaneous tibial nerve stimulation (TTNS).   "
54412|NCT02573389|"     To determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact     the incidence of a post-operative pancreatic fistula, as defined by postoperative. If     pre-operative pancreatic stenting appears to reduce the formation of Postoperative Pancreatic     Fistula (POPF) in this pilot study, this will form the basis of a larger randomized trial in     the future. The hypothesis is that pre-operative pancreatic duct stenting can significantly     decrease the rate of development of a post-operative pancreatic fistula after distal     pancreatectomy.   "
54413|NCT02573376|"     Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users,     yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent     and therefore denied potentially life-saving therapy. This assumption can only be confirmed     or dispelled through prospective pharmacologic and adherence studies in this population. Such     studies would be greatly enhanced by an objective, quantitative measure of adherence which     does not currently exist in the HCV field. Through the work proposed in this application,     sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents     (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed     therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT)     which involves use of a portable medication dispenser that sends a signal to a server with     the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared     in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting     for clinical factors like degree of hepatic impairment and use of concomitant recreational     and antiretroviral drugs. The goal is to quantify adherence in this population and the effect     of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular,     hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to     identify a drug concentration biomarker that predicts adherence in this population. In Aim 3,     the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations)     and rate of cure will be established. The goal is to define the degree of adherence needed     for HCV cure.   "
54414|NCT02573363|"     This phase I trial studies the side effects and the best dose of selinexor when give together     with standard chemotherapy, high dose cytarabine and mitoxantrone hydrochloride, in treating     patients with acute myeloid leukemia. Selinexor may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving selinexor together with standard chemotherapy may be a better     treatment for patients with acute myeloid leukemia.   "
54415|NCT02573350|"     A phase 2, multicenter, uncontrolled, open-label trial in patients with MDR-TB. Only patients     who completed Trial 204 were eligible. The trial was performed globally at 14 sites qualified     to treat MDR-TB. All 434 patients who completed Trial 204 were eligible for this trial if     there was still potential clinical benefit to them and all inclusion criteria and no     exclusion criteria were met.   "
54417|NCT02573324|"     This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and     temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in     participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor     (EGFR) amplification.      In addition, there is a Phase 1, open-label, multicenter sub-study to assess the     pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed     EGFR-amplified GBM who have mild or moderate hepatic impairment.   "
54418|NCT02573311|"     An actual use study to assess how men who respond to advertisements about urinary symptoms     use tamsulosin in a simulated Over the Counter (OTC) setting including following stop use     and ask a doctor if and ask a doctor before use statements and if they take the medication     according to the label instructions, also assess any reported adverse events during simulated     OTC use.   "
54419|NCT02573298|"     The primary aim of the study is to evaluate the effects of two local cryotherapy (ice or cold     gas) applications on arthritic knees.      Evaluation criteria (before/after treatment):        -  synovial power-Doppler semi-quantitative score        -  pain VAS (mm)        -  cytokine levels in synovial fluid        -  leukocyte count in synovial fluid   "
54422|NCT02573259|"     Protocol B8011001 is a Phase 1, open-label, multi center, multiple-dose, dose escalation,     safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 administered     intravenously/subcutaneous in previously treated adult patients with locally advanced or     metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, or relapsed or refractory cHL or     other solid tumors. This 2 Part study will assess the safety and tolerability of increasing     dose levels of intravenous (IV)/subcutaneous (SC) PF-06801591 and in Part 2 will establish     the recommended Phase 2 dose (RP2D).   "
54423|NCT02573246|"     Psychological treatments are effective, but take a long time and can be burdensome.     Therefore, avenues to optimize behavioral treatments are needed. Despite important     advancements, neuroscience has had a limited effect on psychotherapy development. Therefore,     one paradigm shift would be to develop neuroscience informed behavioral treatments.      The investigators identified from the literature a problem that affects several mental     disorders (emotion dysregulation) and a neural circuit that underlies this important concern.     They found that this circuit is dysfunctional in those with psychopathology but can be     changed with treatment. The goal is in one session to train this brain network to operate     more efficiently and to test the short and long term effects of this intervention. The     investigators plan to engage this brain network using a traditional psychotherapy strategy     (cognitive restructuring) and to enhance learning using repetitive transcranial magnetic     stimulation (rTMS), a neuromodulation technique through which magnetic stimulation enhances     the electrical activity in brain areas close to the scalp.      The study team proposes to include 65 participants divided into 3 groups. All participants     will be trained in emotion regulation by first being asked to remember an event where they     experienced a negative emotion and then being instructed either to think differently about     the event, or to wait. Participants will simultaneously undergo either real (left or right     side of brain) or sham rTMS. The investigators will measure their regulation in the lab and     during a-week long naturalistic assessment. Participants will return to rate feasibility,     acceptability, and to provide feedback. If successful, this proof of concept study can open     new frontiers for neuroscience informed treatment development.   "
54424|NCT02573233|"     Primary Objective:      To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients     with persistent asthma.      Secondary Objective:      To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.   "
54425|NCT02573220|"     This phase I trial studies the side effects and the best dose of irinotecan hydrochloride,     based on a genetic test, when given in combination with fluorouracil, leucovorin calcium, and     cetuximab as first-line therapy in treating patients with an abnormal gene called RAS     wild-type that has spread to other parts of the body (metastatic). Patients may also have a     gene called uridine diphosphate glucuronosyltransferase (UGT1A1) that may interfere with the     way irinotecan hydrochloride is absorbed by the body and may not be able to tolerate it.     Determining the presence of this gene may help determine the best dose of irinotecan     hydrochloride when given with fluorouracil and leucovorin calcium (FOLFIRI). Combination     chemotherapy, such as FOLFIRI, works in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Cetuximab may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving FOLFIRI together with cetuximab may be a better treatment for     patients with colorectal cancer.   "
54426|NCT02573207|"     This study will collect clinical, echocardiographic, nuclear imaging and hemodynamic data in     a group of patients with end stage ischemic cardiomyopathy undergoing left ventricular assist     device (LVAD) implantation to investigate the incidence of recovery of myocardial function     when supported with LVADs, and to study the association between hibernating myocardium and     myocardial recovery in this population.   "
54427|NCT02573194|"     Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance     becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion     adults being overweight.      Consumption of foods that can affect appetite by increasing satiety could regulate the total     energy intake and thus body weight. There is data suggesting that the macronutrient     composition of the foods and especially protein content may have a potent role on satiety.     However, the type of protein appears to play a role in satiety possibly due to the different     balance of the amino acid profile.      The research project is dedicated to identify the source (animal or plant) and the optimized     protein quantity needed to accelerate satiation, suppress appetite and extend satiety until     hunger appears again.      It is hypothesized that the consumption of animal derived protein-enriched meals will induce     a reduction in hunger through the impact on gut hormones and peptides that are closely     related to the short-term regulation of food intake.   "
54428|NCT02573181|"     This study is designed to assess the safety, tolerability, and immunogenicity of V114     compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated     with 23-valent pneumococcal polysaccharide vaccine.   "
55245|NCT02562521|"     The purpose of this study is to evaluate a smoking cessation program for employees at the     Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3     control sites) will be offered a contingency management/pharmacotherapy smoking cessation     intervention at the work site.   "
54429|NCT02573168|"     Evidence exists supporting the ability of genetic variations to influence patient drug     response and side effects. To-date, no RCT has been conducted to evaluate the outcomes in     schizophrenia/schizoaffective disorder patients following the use of pharmacogenomic guidance     of treatment selections. The first objective of this trial is to utilize a double-blinded,     randomized clinical trial design to evaluate the clinical outcomes in participants treated     with the benefit of GeneSight Psychotropic (GEN) test. Another objective is to determine the     added benefit of Enhanced-GeneSight (E-GEN) compared to GEN for the pharmacogenomic guidance     of treatment selections. Furthermore, this trial intends to develop an evidence-based case     for the value of GEN and E-GEN to Canadian healthcare payers.   "
54430|NCT02573155|"     This is a phase I, randomised, placebo-controlled 2-part study to assess the safety,     tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in     asthmatic and chronic obstructive pulmonary disease (COPD) subjects.   "
54441|NCT02573012|"     This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group,     international, multicenter trial compares the change in disease activity (as assessed by     Disease Activity Score in 28 joints [DAS28] erythrocyte sedimentation rate [ESR]) from     randomization to Week 24 post-randomization, in participants with stable low disease activity     [LDA] (DAS28 ESR score less than or equal to [<=] 3.2) who receive tocilizumab, and have been     randomized to either continue or taper prednisone in a double-blinded fashion.   "
54431|NCT02573142|"     The primary aim of this study is to reduce body mass index (BMI) among children ages 5-11 who     are obese by integrating behavioral treatment strategies in both clinic (Healthy Lifestyles)     and community (Bull City Fit) settings. A two-group randomized, controlled, non-blinded pilot     design will be utilized. The intended target population is the adult caregiver and a child     with obesity (BMI ≥ 95th percentile) aged 5-11. The intervention condition will be standard     care with Healthy Lifestyles programming plus Bull City Fit; upcoming activities will be     texted to the parents mobile device using GoogleVoice. The control condition will be standard     clinical care with Healthy Lifestyles programming. Primary outcome is BMI at 6 months.     Secondary outcomes include anthropometric, psychosocial, and reported health behaviors.   "
54432|NCT02573129|"     The purpose of the proposed research study is to assess the effects of including greater     amounts of minimally processed red meat (lean pork and beef) into a Mediterranean Diet on     cardiometabolic and emotional well-being.   "
54433|NCT02573116|"     Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in     patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP.     Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2     (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral     Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3     (20 weeks) after periodontitis treatment for the group of patients with chronic     periodontitis.   "
54434|NCT02573103|"     To determine the effects of ambient airpollution exposures on lipid metabolism among healthy     adults without cardiovascular disease.   "
54435|NCT02573090|"     The research project SEAL-DK is focusing on advantages and disadvantages of two treatment     strategies: non-invasive fissure sealing and invasive restorative treatment of manifest     occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the     project is to promote the understanding of the possibilities of non-invasive treatment of     occlusal caries lesions in the permanent dentition, and to increase the present knowledge     about the optimal threshold for sealing or restoration, respectively, when treating such     lesions.      The project is carried out as a randomized study of the two treatment strategies:     non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is     emphasized that no treatment shall be carried out, if conflicting the participating dentists'     perception of clinically proper caries treatment, and that the results shall have a high     reliability and consistency.      The hypothesis is that caries progression can be stopped by non-invasive fissure sealing     changing the threshold and postponing the time for invasive restoration.   "
54436|NCT02573077|"     This observational, prospective, non-interventional study will include cancer patients who     need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed     treatment(s) according with the clinical practice regardless of the patient participation in     the study. The purpose of this NIS is to collect additional scientific and clinical     information that can help in describing the characteristics of cancer patients with     hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to     keep under control serum [Na+] and the guidelines for the management of this population in     Italy.   "
54437|NCT02573064|"     The present study was designed to study the impact of empirical treatment with colistin     empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of     bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the     efficacy of empirical treatment with colistin and combined targeted therapy. The different     therapeutical interventions were administered following the routine clinical practice in the     medical centre and the investigator did not assign specific interventions to the subjects of     the study.   "
54450|NCT02572895|"     The purpose of this clinical trial study is to assess, among young and sexually active women     presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of cranberry     extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs), compared to a     control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs     during a 6-month follow-up period.   "
54451|NCT02572882|"     The Microbiome trial is a non-randomized, open-label, crossover, multi-center study of     p-inulin for patients with hemodialysis-dependent end-stage renal disease.   "
54453|NCT02572856|"     During surgery and after surgery elevated blood glucose levels can lead to poor outcome such     as wound infections. Current technology does not allow close monitoring of glucose levels     often resulting in poor management of glucose levels. In this study, the investigators will     evaluate the feasibility of using a continuous glucose monitor (Dexcom Gen 4 Professional)     during and after surgery. Such a monitor has the potential of monitoring glucose levels     continuously and in real-time, thus allowing better glucose management   "
62394|NCT02468921|"     The aim of the study is to investigate the influence benign non-toxic goitre and the surgical     treatment hereof on the voice function before and 6 months following surgery.   "
54438|NCT02573051|"     Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy     Association estimates that blighted ovum causes approximately 50 percent of all     first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage.      In general, there are 3 options for management of anembryonic pregnancy: expectant, medical,     and surgical management. Expectant management consists of no intervention and awaiting     natural passage of tissue. Medical management uses medication to expel uterine tissue.     Surgical management is defined by mechanical removal of tissue from the uterus.      Medical management allows patients to avoid surgery and anesthesia. Patients may also feel     that medical management is more private, and under their control. Several medications have     been studied for medical management.      Misoprostol, a prostaglandin E1 analogue, is a uterotonic that results in cervical softening     and contractions that expel the products of conception. It may be administered vaginally,     orally, buccally, or sublingually. Adverse effects vary based on route of administration.      There is published literature on a wide range of therapeutic misoprostol regimens. Optimal     dose and route of administration of misoprostol have not been determined by randomized     trials. Overall, misoprostol is safe and well-tolerated.      Patients receiving misoprostol vaginally rather than orally have decreased adverse     gastrointestinal effects and prolonged duration of action.      Oral misoprostol is less effective than vaginal misoprostol in emptying the uterus.     Sublingual misoprostol is equivalent to vaginal misoprostol in inducing complete uterine     emptying but is associated with more frequent diarrhea.      When compared with lower dosages, a dose of 800 µg vaginal misoprostol is more effective at     completing uterine emptying, although it results in a similar incidence of nausea. Based on     international trials in settings with limited resources, WHO recommends a single vaginal dose     of 800 µg misoprostol for medical management of anembryonic pregnancy. Routes of misoprostol     administration include oral, vaginal, buccal or rectal. Vaginal misoprostol is associated     with a greater overall exposure to the drug and greater effects on the cervix and uterus.      Isosorbide mononitrate (IMN) is a drug used principally in the treatment of angina pectoris,     which acts by dilating the blood vessels so as to reduce blood pressure.   "
54439|NCT02573038|"     Angioid streaks are rare lesions associated to retinal pigment epithelium degenerations.      They can be caused by general diseases as pseudoxanthoma elasticum, Paget's disease or     drepanocytosis. Choroidal neovascularization (CNV) represents the most frequent complication     for those patients. It leads to a rapid and important loss of visual acuity. CNV in angioid     streaks represent the fourth leading cause of CNV in young patients.      CNV in angioid streaks is treated at the moment with off-label anti-VEGF (Vascular     Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new     anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need     as many injections as in AMD.      ASTRID is an open-label, single arm, prospective, multicenter, phase II study. The main     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment     with aflibercept on the visual acuity of patients affected by CNV in angioid streaks. A     specific dosage regimen is designed to achieve maximum efficiency. The patients are followed     on a monthly basis until 52 weeks. Six injections are mandatory, the other ones are injected     only in case of active CNV.   "
54440|NCT02573025|"     This is an open-label, randomized, multi-center, single dose, two-period, two-sequence     crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation     versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous     administration via prefilled syringe in healthy Chinese participants.   "
54442|NCT02572999|"     This prospective cohort study aims to determine the incidence of hospitalization-associated     disability and its association with risk factors at the patient level and with care and     hospital processes. For this, patients aged 70 years or older admitted for elective valve     surgery or elective transcatheter aortic valve implantation or as a result of symptomatic     moderate to severe valvular heart disease will be consecutively included from 01 October 2015     to 29 February 2016.   "
54443|NCT02572986|"     Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis     of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and     distribution of the rash. Definitive diagnosis includes the microscopic identification of the     mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug     of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in     adults and children 2 months and older.      This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to     Elimite® in the Treatment of Scabies.   "
54444|NCT02572973|"     The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized     clinical trial examining the feasibility of completing a larger scale efficacy study of a     novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth     with anxiety disorders. The primary objective is to establish the feasibility of a blinded     randomized controlled trial of ANM for childhood anxiety disorders.   "
54445|NCT02572960|"     To investigate possible physiologic interactions between the adrenal- and the parathyroid     glands in patients with secondary hyperparathyroidism.   "
54446|NCT02572947|"     Current HIV treatment guidelines recommend a combination of drugs for the maintenance of     antiretroviral therapy (ART). Simplification is considered critical to further scale-up of     treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily     integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance     profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in     maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on     conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors     (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is     the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing     virological failure.   "
54447|NCT02572934|"     Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy,     alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival rates     are above 90% nowadays, which results in growing TC survivor population. Because of the long     life expectancy of these survivors, prevention or early detection of late treatment effects     has become increasingly relevant. Yet known late effects are nephrotoxicity, cardiovascular     disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary toxicity,     Raynaud's phenomenon, hypogonadism, fatigue and psychosocial problems. Nephrotoxicity is an     important late effect, but data is lacking in very long-term survivors since performed     studies have a follow-up duration of 5-14 years. Decreased renal function is a known risk     factor for CVD development and also an association between renal function and neurtoxicity     via circulating platinum levels has been shown. It is hypothesized that treatment induced     nephrotoxicity is prevalent in TC survivors and might be a mediator for development of late     effects. The secondary aim is to assess prevalence of late effects in very long-term TC     survivors: until now, most data have been collected through questionnaires in large     epidemiological studies in TC survivors till approximately 10 years after treatment. The     prevalence of late effects may increase over time: 10 years after treatment late effects may     not be present yet, whilst late effects can emerge just after 20 years. Consequently, health     status and possible late effects, resulting in morbidity, are underestimated in patients who     are 20-30 years after treatment. By investigating health status of these very long-term     survivors a more profound insight in the prevalence and aetiology of these late effects and     the development over time can be assessed. Current treatment is very similar to TC treatment     20-30 years ago and therefore knowledge on late effects is relevant for currently treated     patients. Furthermore, as a result of this study, we will better understand which factors and     issues should be watched closely during follow-up, which TC survivors are at increased risk     of developing late treatment effects and how to detect early damage before overt morbidity     occurs.   "
54486|NCT02572427|"     The overall goal of this study was to create a simulation environment with repeated practice     for residents and intense, immediate feedback. Repeated simulations for neonatal     resuscitation when coupled with clinical experience have been shown to improve resident     confidence.The investigators sought to determine if resident exposure to individual training     and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and     decrease intubation times in a neonatal manikin. The primary outcome was time to intubation     after one year. The secondary outcome was the ability to retain cognitive instruction related     to intubation   "
56130|NCT02550925|"     This randomized clinical trial compares group acceptance and commitment therapy (ACT) to     usual care for cancer survivors experiencing anxiety following the end of cancer treatment.   "
54455|NCT02572830|"     Blocking of reconsolidation by pharmacological or behavioral means offers the therapeutic     possibility of weakening traumatic memories in posttraumatic stress disorder (PTSD). Two     reconsolidation-based interventions, propranolol and extinction learning, have been shown to     weaken fear memories in human healthy subjects. However, the success of these interventions     seems to be limited to weak conditioned fear memories. This calls for new, potentially more     efficacious, interventions to be tested. Bilateral eye movements seem to be a promising     candidate intervention for blocking reconsolidation due to the compelling evidence of Eye     Movement Desensitization and Reprocessing as effective treatment in PTSD. The investigators'     aim is to test bilateral eye movements as an active reconsolidation-blocking intervention in     an optimized differential fear conditioning procedure that the investigators have recently     developed. This novel experimental assay creates stronger fear memories in healthy     individuals.   "
54456|NCT02572817|"     This study will assess the efficacy and safety of anti-influenza immune plasma, as an     addition to standard of care antivirals, in participants hospitalized with severe influenza A     infection.   "
54457|NCT02572804|"     This is a prospective randomised controlled trial that will compare the outcomes of rectus     sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower     midline abdominal incision for bladder cancer.   "
54458|NCT02572791|"     The investigators propose a pragmatic comparative effectiveness trial evaluating several     decolonization strategies in patients with Staphylococcus aureus infection, their household     contacts, and household environmental surfaces. The central hypothesis of this proposal is     that an integrated approach of periodic personal and household environmental hygiene will     reduce S. aureus transmission in households and subsequently decrease the incidence of skin     and soft tissue infections (SSTI).   "
54459|NCT02572778|"     The investigators want to have a collection of fresh primary or recurrent tumor tissue for     establishment of patients-derived xenografts in order to:      generate a biobank of in vivo patient xenografts representing the different subgroups of     tumors for head and neck cancer        -  perform genetic and transcriptional profiling of the primary, metastatic tumors and          xenograft tumors        -  evaluate the efficacy of new targeted agents, whether or not in combination with          standard treatment options        -  evaluate biomarkers of drug sensitivity        -  study primary and secondary (acquired) resistance in these models   "
54460|NCT02572765|"     The purpose of this study is to evaluate the splenic activation in hypertensive patients, as     compared to normotensives, using FDG-PET/CT imaging. Moreover, the investigators will     investigate whether the splenic metabolic activity relates to the expression of circulating     inflammatory proteins (high-sensitivity C-reactive protein [hsCRP]), interleukin-1b (IL-1b),     tumor necrosis factor-a (TNF-a) or to immune profiles of activated T cells.   "
54461|NCT02572752|"     To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib     compared to 2 soft gelatine capsules containing 100 mg nintedanib   "
54462|NCT02572739|"     Thermodilution cardiac output measurement is a reliable method, but it is an invasive one.     PiCCO device requires cannulation of central vein and peripheral artery. Impedance method     requires only attachment of special electrodes. Non-invasive methods are less accurate. Aim     of study is to assess accuracy and reliability of impedance method ( using NICCOMO device) in     comparison of thermodilution method ( using PiCCO device) at different PEEP levels.   "
54463|NCT02572726|"     Transcranial magnetic stimulation (TMS) is a neurophysiological tool for studying cortical     functions, and in addition, has an analgesic therapeutic effect whose underlying mechanism is     unknown. The proposed research will use TMS in conjunction with brain imaging and     electrophysiology to examine cortical plasticity and connectivity modifications induced by     repetitive TMS (rTMS) targeted to affect cortical regions associated with endogenous     analgesia (EA). This will be carried out in both healthy and chronic pain (fibromyalgia)     states. rTMS analgesic intervention, targeted to the motor cortex (M1) will be preceded and     followed by structural and functional magnetic resonance imaging (fMRI), and Diffusion Tensor     Imaging (DTI). This will be done in order to examine alterations of cortical and brainstem     mechanisms involved in EA and to investigate connectivity changes between cortical and     sub-cortical regions of the EA networks. The latter as well as EA efficiency and pain-related     personality variables will be used to assess individual differences in neuroplasticity within     the EA systems in both healthy subjects and chronic pain patients.   "
54464|NCT02572713|"     The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids     in Parkinson's disease (PD). This may help in developing better treatments for PD patients in     the future.   "
54465|NCT02572700|"     The objective of the study is to investigate pain mechanisms, ultrasonographic (US)     inflammatory activity and association between these conditions in patients with psoriatic     arthritis (PsA) intensifying anti-rheumatic treatment. Further, to assess the predictive     value of baseline pain profile and US joint/entheses activity on treatment outcome after 4     months.   "
54466|NCT02572687|"     The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in     participants with locally advanced and unresectable or metastatic gastrointestinal or     thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma,     non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).   "
54888|NCT02567188|"     An observational, longitudinal, multi-center, non-interventional study in participants with     chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease     (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis     situation who are treated with MIRCERA in normal clinical environment.   "
54522|NCT02571959|"     Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy     voluntary obese after oral and intra venous administration Determination of the     pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic     concentrations of intravenous injection (IV) and oral administrations. The criterion of     evaluation allowing to answer our main objective corresponds to the parameters estimated by     the pharmacokinetic model of the concentrations obtained from the data IV and by the     pharmacokinetic model of the concentrations obtained from the oral data. The following     pharmacokinetic parameters will be considered at every obese volunteer's for both molecules     (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of     population.      The main evaluation criteria are PK parameters of amoxicillin / clavulanic:        -  Cl, systematic plasmatic clearance        -  Vd, volume of distribution        -  ASC 0-oo, area under the curve time - concentration        -  T1/2, half-life time        -  F, bioavailability after oral administration        -  Ka, constant of speed of absorption   "
54467|NCT02572674|"     Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal     objective of this research is to test the predictive value of core vulnerability dimensions     such as affective instability and emotional reactivity, measured by validated questionnaires     (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic) during     a 24 months prospective follow-up.      In addition, several arguments suggest that inter-individual variability in the risk of     relapse is influenced by genetic factors. In particular, the implication of such factors have     been demonstrated in rapid cycling or antidepressants induced mania. However, this has never     been tested in cohorts followed prospectively. Finally, the existence of neuropsychological     deficits in bipolar disorder is well documented and their role in the risk of relapse is     suspected. Yet the nature of these deficits, their origin and evolutionary course remain     poorly investigated. In summary, the secondary objectives of this research are the study of     the influence of these other clinical, neuropsychological and genetic factors on the risk of     relapse.      • Scientific rationale The dimensions of affective instability and emotional reactivity, are     considered core psychological and temperamental vulnerability dimensions to bipolar disorder.     Differences in levels of instability and reactivity may account for the inter-individual     variability observed in bipolar disorder in terms of risk of relapse. These dimensions are     measured using validated questionnaires (Affective Instability Measure (AIM) and Affective     Lability Scale (ALS)). Relapsing is defined as the occurrence of a depressive episode,     hypomanic, manic or mixed episode (DSMIV criteria).      Other factors that may influence the risk of relapse have been suggested in the literature     but have not been formally tested in prospective studies:        1. cognitive deficits: the existence of neuropsychological deficits in bipolar disorder are          well documented and their role in the risk of relapse is suspected. Yet the nature of          these deficits, their origin and their course remain poorly investigated. Indeed, some          appear to be related to the neurotoxicity of the episodes themselves, the other being          related to the vulnerability to bipolar disorder        2. The involvement of genetic vulnerability factors in bipolar disorder is widely          demonstrated. Several arguments suggest the implication of genetic factors in the risk          of relapse. This is the case for some outcome patterns such as rapid cycling or          antidepressants induced mania. Again, this has never been tested in cohorts followed          prospectively.        3. The role of certain inflammatory and infectious factors in the etiology of bipolar          disorder has been suggested but it is clear whether these biomarkers are state or          traits. Thus, the role of neurotoxic inflammatory or infectious factors in relapse          mood has never been tested in a prospective follow up studies.             -  Main objective of the project To determine if the scores of AIM and ALS, assessed               at baseline in euthymic bipolar patients is associated with relapse in patients               during a 2 years follow-up period.             -  Secondary objectives of the project Determine if the neuropsychological performance               at T0, measured in euthymic patients predict relapse during a 2 years follow-up               period.      Determine whether the neuropsychological deficits observed in euthymic bipolar patients that     contribute to functional impairment worsen with time.      DNA collection to test the involvement of candidate genes Serum collection to study the     biological and infectious biomarkers      • Methodology Prospective follow up studies. Multicenter.   "
54468|NCT02572661|"     This study aims to explore the feasibility, safety and outcome of a non‐invasive sentinel     node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the     ipsilateral neck only and to exclude the contralateral negative neck from the irradiation     fields when there is no draining sentinel node. Subsequently the dose to the salivary glands,     mucosal area and the swallowing and chewing muscles and structures involved in voicing and     articulation will significantly be reduced   "
54469|NCT02572648|"     The purpose of this study is to examine the relation between the structural brain changes     associated with heart failure, neurocognitive performance, and how these changes impact     self-care behaviors.   "
54470|NCT02572635|"     Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses     or lungs. It can also cause more serious infections of the blood or brain. The elderly and     young children are more vulnerable to these types of infections.      The vaccines available at present are effective only on a certain number of strains of the     bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains.     This study will be looking at the safety and tolerability of the study drug for three     different dosages: 50 μg, 200 μg, and 500 μg compared to placebo.      The population eligible to take part in the study are healthy male and female subjects     between 18 and 40 years of age.      Volunteers for the study will be recruited through advertisements. Each volunteer will have     received an information sheet concerning the study and will have agreed to participate in     writing. Volunteers will be given at least 48 hours between reading the information leaflet     and agreeing to participate. Only subjects who agree to undertake precautions to avoid     pregnancy of either themselves of their partner during the study period will be eligible.     Volunteers will give signed consent for their physician to be notified about their     participation in the trial.   "
54471|NCT02572622|"     The aim of this study is to determine the effectiveness of three different treatment methods     which consists spinal decompression, deep friction massage and exercise. The patients were     separated three groups Group one received non-surgical spinal decompression therapy, group     two received non-surgical spinal decompression, lumbar stabilization exercises and manual     therapy, group three received manual therapy and lumbar stabilization exercises. All groups     completed 15 sessions of therapy. In each session, pain severity was assessed with numeric     analog scale, straight leg raise test applied and the degree of the hip flexion where the     patient reported pain were recorded, respectively. Static, dynamic muscle strength-endurance     tests were applied before the treatment sessions started, after the treatment sessions ended,     six weeks after and three months after the study. Oswestry Disability Scale (ODI), Back     Performance Scale (BPS), Lanss Neuropathic pain Questionnaire, Fear-Avoidance-Beliefs     Questionnaire (FABQ) and McGill Pain Questionnaire were applied before the treatment sessions     started, after the treatment sessions ended and three months after the study. Gradient of     disc height and thickness of the herniation were assessed segmentally with magnetic resonance     imagination (MRI) before the study and three months after the study.   "
54472|NCT02572609|"     to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation),     manufactured by Bolder Arzneimittel GmbH & Co. KG to Boehringer Ingelheim compared to     ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim     do Brasil Química e Farmacêutica Ltda.   "
54473|NCT02572596|"     Comparing intermediate-dose CTX (ID-CTX)and G-CSF with rhTPO or without for peripheral blood     stem cell mobilization in patients with multiple myeloma, try to find out whether rhTPO     combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell     mobilization.   "
55363|NCT02559934|"     The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing     2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of     solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous     dermal treatment area.   "
54474|NCT02572583|"     This prospective randomized controlled trial studies the efficacy and safety of treating     influenza with the reconciling exterior and interior therapy. A total of 300 cases of     seasonal flu in Beijing is to be collected, and divided into one treatment group and two     control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while     patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate     Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of     treating influenza with the reconciling therapy based on the following outcome measures: the     time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it     takes for the body temperature to return to normal.   "
54475|NCT02572570|"     Polymerization shrinkage remains one of the primary disadvantages of composite resin     restorative materials (tooth-colored fillings). To minimize the effects of polymerization     shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin     called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and     properties allow the material to be inserted in one single increment, expediting treatment.     This clinical trial is designed to evaluate the performance of the new bulk fill composite     resin in Class II (two-surface posterior) fillings.   "
54476|NCT02572557|"     Rationale: Spray cryotherapy (SCT) using liquid nitrogen has been safely and effectively used     in the esophagus, airways and pleura. Treatment with SCT for central airway stenosis may     provide an effective, and more durable and perhaps safer alternative to the current     therapeutic modalities.      Objectives:        1. To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of          malignant and benign central airway disease.        2. To investigate the safety of using Spray cryotherapy (SCT) for the treatment of          malignant and benign central airway disease.        3. To investigate the efficacy of using Spray cryotherapy (SCT) for the treatment of          malignant and benign central airway disease.      Study design: This study will be a prospective, single arm, open label intervention study     performed at the University Medical Center Groningen, The Netherlands Study population: The     study population exists of 25 patients with malignant or benign central airway disease.     Patients in which current treatment options are regarded to be suboptimal can be included in     the study.      Intervention: TruFreeze Spray CryoTherapy      Main study parameter:      Feasibility is defined as being able to apply the SCT as planned in one, or more     bronchoscopies according to the instructions for use (IFU).      Secondary study parameters:      Safety will be assessed by capturing all adverse events (AEs) that occur 1) during the SCT     procedure, and 2) all AEs that occur until hospital discharge.      Efficacy will be measured using 1) patient reported outcomes (questionnaires), 2) percentage     improvement in airway stenosis, 3) durability of treatment effect, 4) need to re-intervene     with other therapies because of treatment failure.      Nature and extent of the burden, risks and benefit associated with participation.      Patients that will be recruited and participate in this prospective clinical trial have a     severe central airway disease which is highly symptomatic for which current available     therapies are either very difficult to perform, are hazardous, have no real benefit, or just     simply not available yet. The current treatment risks of this patient group are high,     especially in the patients where the airway patency is at risk. The main additional risk     associated with the use of SCT is the occurrence of a pneumothorax. Patients participating     will adhere to their current medical care, with the one addition of a voluntary follow-up     bronchoscopy after SCT.   "
54477|NCT02572544|"     Purpose of this study is to compare the ocular functional changes including pupil size,     visual acuity, depth of focus, accommodative amplitude, visual field, contrast sensitivity,     and stereopsis induced by multiple and single pinhole glasses, in addition, to check reading     speed and survey for ocular discomfort after using both pinhole glasses.   "
54478|NCT02572531|"     The aim of this research is to study the effect of probiotic supplements (Lactobacillus     reuteri) on post-surgical complications and oral wound healing after extraction of impacted     third molars.   "
54479|NCT02572518|"     To evaluate the immune status of yellow fever in adults with a history of two or more doses     of vaccine, having received the second dose for at least 1 year, compared to re-vaccinated     individuals (second dose) after 30 days.   "
54480|NCT02572505|"     Human immunodeficiency virus (HIV) infection has now become a treatable disease and many     infected individuals are interested in having a family. Couples in which the man is infected     but the woman is HIV-negative (hereafter referred to as HIV-discordant) require medical     intervention during procreation to prevent HIV transmission to the female and her child. The     current view is that reducing the number of infections involving unprotected intercourse in     HIV-discordant couples is a public health issue in the U.S. The safest methods for     HIV-discordant couples are insemination using a sperm donor, adoption and remaining     childless. However, some couples strongly desire a biologically related child. Fertility     clinics in the United States have been resistant to treating HIV-discordant couples, offering     only expensive, invasive techniques. This reduces access to care, leading to couples choosing     unprotected intercourse to conceive a child. Pre-exposure prophylaxis (PrEP) is a treatment     taken by the woman before having unprotected intercourse with an infected man. Truvada has     been approved by the Food and Drug Administration (FDA) to reduce the risk of HIV-discordant     couples and the Centers for Disease Control and prevention (CDC) has recommended that     serodiscordant patients who wish to have a child be counseled on the availability of PrEP.     When risks of transmission are minimized, including undetectable HIV in blood and use of     PrEP, unprotected intercourse during the fertile period is likely to be a safe option for     conceiving a child. The investigators propose to enroll HIV-discordant couples who have been     counseled on the safer alternatives of donor insemination, adoption and remaining childless;     have been offered referral to a clinic offering sperm washing with insemination or in vitro     fertilization (IVF); have been apprised of the risks of using PrEP and one timed intercourse     per cycle; and decide to proceed with this method. Couples will be from the population of     HIV-discordant patients with a minimal risk of disease transmission as described above. After     evaluation for normal fertility and low potential for disease transmission, the couple will     receive instruction on timing of the most fertile day of the cycle, and the woman will be     given a prescription for the PrEP medication. The woman and any offspring will be followed     for 6 months using blood tests to check for evidence of HIV infection.   "
54481|NCT02572492|"     This study evaluates induction therapy with carfilzomib-cyclophosphamide-dexamethasone before     salvage high-dose melphalan with autologous stem cell support (HDT) in multiple myeloma     patients with relapse after HDT done at diagnosis. In addition, the study evaluates the     effect of maintenance therapy after salvage HDT in multiple myeloma. After salvage HDT half     of the patients receive maintenance therapy with carfilzomib/dexamethasone while the other     half are observed without maintenance therapy.   "
54482|NCT02572479|"     The proposed observational trial will collect substantial data concerning dietary intake     documented by ALS patients complemented by the analysis of fatty acid distribution in     erythrocyte lipids. Both data sets are related to disease status and progress.   "
54483|NCT02572466|"     This study objective is to compare the high sensitive troponin-I level in end-stage renal     disease patients received hemodialysis without acute cardiovascular event with healthy     population. The investigators also determine the effect of hemodialysis on troponin I level     as the secondary objective.   "
54484|NCT02572453|"     This phase II trial studies how well onalespib works in treating patients with anaplastic     large cell lymphoma, mantle cell lymphoma, or diffuse large B-cell lymphoma that has not     responded to previous treatment or that has returned after a period of improvement. Onalespib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
54543|NCT02571686|"     The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and     severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief,     steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation     (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted     by pulse oximeter manufacturers to the FDA for device approval.   "
54485|NCT02572440|"     Perioperative blood loss continues to be a serious problem in complex aortic arch surgery     using deep hypothermic circulatory arrest (DHCA). Major blood loss causes increased morbidity     and mortality [1]. These patients often require transfusion of allogeneic blood products. It     has been estimated shortages of blood supply in China will worsen [2]. Clinicians have made     significant progress to decrease the quality of allogenic blood transfusion.      Increasing postoperative hemorrhage risk of aortic arch patients undergoing DHCA may be     related to CPB induced hemostatic defect, the use of the CPB is likely to contribute to     coagulation factor lost and platelet dysfunction [3, 4]. We are aware of the potential     benefit of aPRP, withdrawal of aPRP immediately before initiating CPB appears to be a     promising approach because it avoids CPB-related platelet damage and limits post-CPB blood     loss. So we adopted and used aPRP as a blood conservation technique to reduce blood     transfusion in aortic arch surgery with DHCA. Autologous red blood cells were infused to     maintain a HGB level above 100 g/L after heparin neutralizing activity. And aPRPs were     transfused after heparin neutralizing activity as no active bleeding was observed. Our goal     was to determine the effect between aPRP and homologous transfusion on perioperative bleeding     during complex aortic arch surgery using DHCA.   "
54576|NCT02571257|"     The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid     parameters in hypercholesterolemic patients on a stable dose of a statin.   "
56131|NCT02550912|"     The purpose of this study to determine whether high dose vitamin D has positive effect on     behavior of autistic children.   "
56132|NCT02550899|"     A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide     hydrogel injection therapy for anal incontinence.   "
54487|NCT02572414|"     African American men infected with HIV are living longer and are acquiring the same chronic     non-communicable diseases affecting the general population of African American men age 40     years and older. African American men have disproportionately high rates of cardiovascular     disease, hypertension, diabetes, kidney disease, and cancer, particularly prostate and colon     cancer, but HIV is associated with an increased risk for co-morbidity from these conditions,     a risk heightened by not only HIV infection itself, but also its treatment with     antiretroviral therapy (ART). The risk for many of these chronic diseases is tied to     behavior: risk is increased by physical inactivity and unhealthful diet. Although the high     risk for behavior-linked chronic diseases among HIV-positive individuals has been recognized,     there is a lack of evidence-based interventions specifically tailored to their needs.      Hence, the broad objective of this research is to identify strategies to empower HIV positive     African American men to engage in behaviors that reduce their risk of chronic diseases. This     research will test the efficacy of a theory-based, contextually appropriate health promotion     intervention in inducing positive changes in behaviors linked to risk of chronic diseases     among HIV positive African American men age 40 years or older and will identify the     theoretical variables that mediate its efficacy.      In a randomized controlled trial, African American HIV positive men age 40 or older who are     receiving ART for HIV will be randomized to the Men Together Making a Difference Health     Promotion Intervention, which consists of three, 3-hour weekly intervention sessions, or the     1 session Health Awareness Control Group. The Men Together Making a Difference Health     Promotion Intervention is based on social cognitive theory and the reasoned action approach     integrated with formative research. Data will be collected at baseline, immediately post, and     3, 6 and 12 months post intervention. The trial will test whether the Men Making a Difference     Health Promotion Intervention increases self-reported physical activity compared with the     Health Awareness Control Group.   "
54488|NCT02572401|"     African American men have by far the highest rates of HIV in the US, but there are few     randomized controlled trials (RCTs) of interventions to dissuade heterosexually active     African American men from engaging sexual risk behavior. This research seeks to address this     gap in the behavioral intervention literature. That self-initiated behavior change, as well     as intervention-induced behavior change, is often short-lived, eroding over time, is widely     known; accordingly, this research also seeks to test a strategy to sustain intervention     efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected     intercourse with a woman will be randomized to the Steering Together in a New Direction     (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a     strategy to sustain intervention effects, the men also will be randomized to receive or not     receive individually tailored text messages. The theoretical basis of the interventions is     social cognitive theory and the reasoned action approach, which is an extension of the theory     of planned behavior and the theory of reasoned action. Men will complete self-report measures     via audio computer-assisted self-interviewing at baseline and immediately post and 6 and 12     months post-intervention. The trial will test whether the STAND HIV Risk Reduction     Intervention as compared with the No-Intervention Control Condition, increases consistent     condom use, the primary outcome. Secondary outcomes include unprotected intercourse, multiple     sexual partners, insertive anal intercourse, and proportion condom-protected intercourse. The     trial will also test whether STAND's efficacy is greater among men in the Text Messaging     Intervention compared with men not receiving text messages. This will provide information on     the utility of a low-cost strategy to extend an intervention's efficacy. Finally, the study     will test for mediation of intervention effects: the hypothesis that STAND affects outcome     expectancies and self-efficacy, which, in turn, affect consistent condom use.   "
54489|NCT02572388|"     This is a clinical trial in which healthy volunteers will be administered one or two     experimental malaria vaccines. The vaccine R21 will either be administered alone or in     combination with the adjuvant vaccine Matrix-M1.      All vaccinations will be administered intramuscularly. Each volunteer will receive three     vaccinations in total.      There are three different vaccine schedules:      Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.      Group 2 will receive 50µg of R21 on days 0, 28, and 56. .      Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.      The study will assess the safety of the vaccines, and the immune responses to the     vaccinations. Immune responses are measured by tests on blood samples.      Healthy adult volunteers will be recruited in Oxford and London, England.   "
54490|NCT02572375|"     The objectives of this pivotal study are:        1. to evaluate bioavailability of an extended-release and immediate release Codeine          Phosphate/Guaifenesin tablet at steady state following multiple oral administration        2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended          release formulation.   "
54491|NCT02572362|"     Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and     volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having     had radiation therapy for rectal cancer. Twenty-five patients are included in this study.     Planning CT scans are used for comparison of dose distribution and calculation of second     cancer risk.   "
54492|NCT02572349|"     The objectives of the study are to assess the safety and tolerability of a range of single     doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the     pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701     when administered as oral capsules to healthy subjects.   "
54529|NCT02571868|"     AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular     function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of     echocardiography. St Jude Medical has developed an automated algorhythm which calculates the     optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2     minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead     position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm     performance in the mid- and long-term with RV lead located in mid-septum.   "
54493|NCT02572336|"     This study will test the experimental drug THR-18 given together with the drug tissue     plasminogen activator for the treatment of stroke. Tissue plasminogen activator is also     called tPA.      Strokes often result from blockade of blood supply caused by blood clots forming within the     blood vessel feeding the brain. Such strokes are called Ischemic strokes. Treatment of     these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before     further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when     it is injected into a vein shortly after the stroke starts. However, along with breaking up     the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding.     THR-18, the drug tested in this study, is meant to reduce tPA's adverse effects without     stopping tPA's breaking up of the blocking blood clot.      The aims of this study are to evaluate the safety of THR-18 in acute ischemic stroke patients     who are treated in parallel with tPA, to measure tPA's effect on blood clot dissolution when     this drug is given with and without THR-18, and to study the effects THR-18 may have on     signals of brain damage as seen on brain computerized tomography (a type of brain x-ray)     after treatment with tPA with and without THR-18. Patients will also be evaluated for their     ability to perform daily activities after the stroke following tPA treatment with and without     THR-18.      The evaluation of THR-18 in this study will be done in comparison to placebo. Placebo is a     drug that looks exactly like THR-18 but has no activity. One dose of THR-18 will be tested,     in 20 patients. In parallel, 20 other patients will receive placebo. In total, 40 patients     are planned to participate in this study. The decision whether a patient will receive THR-18     or placebo will be based on chance (this procedure is called randomization). This clinical     study will be conducted only at one hospital, in the Republic of Moldova. The patients will     be in the hospital for at least 3 days after receiving the study treatment. Then, about 1     month later, they will be invited for a last follow-up visit.   "
54494|NCT02572323|"     The aim of this study is to test whether tesamorelin, in combination with a text-messaging     application to help with motivation and adherence, will significantly improve memory and     thinking in HIV.   "
54495|NCT02572310|"     In this study the investigators propose to monitor subjects who have received Triathlon total     knee components inserted with HV cement. The primary outcome will be fixation of the tibial     implant component as assessed with RSA and to determine the functionality of patients after     surgery using self-reported questionnaires. This is a historical control study, comparing the     study cohort to a previous group with Triathlon implants and the long-standing Simplex T     cement. The secondary outcomes are inducible displacements of the implants as well as a     qualitative evaluation of the cement handling characteristics performed by the operating room     staff.   "
54619|NCT02570698|"     The primary objective of this study is to collect feces from premature infants over a five     weeks period to characterize its composition. Metabolomics, Proteomics, Genomics and     Microbiome analyses and cell-based assays will be performed to identify individual components     present in feces, which may contribute to the onset of irritation in the diapered area of     premature infants.   "
54496|NCT02572297|"     Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient     associations involved in epilepsy. These represent a priority for the Ligue Française Contre     l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years,     suffering from epilepsy uncontrolled by medication. In this population of close to 100,000     people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per year.     It is clear that the majority of these deaths occur in the immediate consequences of a     crisis..      Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per /     post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution of     a cohort of 1500 patients clinically well described and a national database will allow other     ambitious projects in a speciality where French centres benefit from a unique knowledge,     recognized by their foreign colleagues, but underexploited to date. The LFCE (Ligue Française     Contre l'Epilepsie) is developing structuring actions to facilitate such exploratory studies     for the next two years.      The high death rate which characterizes the drug-resistant partial epilepsies and, in     particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of research     for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of epileptic     patients and the European representatives of the international league against epilepsy (     ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned against     SUDEP.      Although the SUDEP physiopathology remains uncertain, many elements plead for the essential     role of a per-and post-critic apnea (central or obstructive). Investigators observe that     about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their     crisis are going to present experience an per / post-critic severe apnea, severe per /     post-critic enough to have induce a SpO2 < 80 % decrease.      However, today, no study has estimated the link relation between the arisen occurrence of     such apneas and the later risk of SUDEP.   "
54497|NCT02572284|"     The purpose of this study is to compare the effects, good and/or bad, of different doses of     SBRT given before prostatectomy. Depending when participants enter the study, they will be     treated with either 5, 6 or 7 gray (Gy) per day of radiation. A Gy is a measure of radiation     dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and     no surgery is planned. The researchers want to see which dose of radiation will work best     with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a     prostatectomy.   "
54498|NCT02572271|"     The purpose of this study is to compare two different techniques of mastopexy with autologous     augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins     Mastopexy with autologous augmentation, in massive weight loss patients to see if one     technique is superior to the other.   "
54499|NCT02572258|"     The study will evaluate the impact of a supplementary food (cookies) in preventing the risk     of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.      Children will be divided in two groups; one will received the cookie plus 12 educative     sessions and the other just the educative program. The study will last 12 months   "
54500|NCT02572245|"     This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC)     injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects   "
54501|NCT02572232|"     The purpose of the study is to compare three supraglottic airway devices (Combitube,     Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway     scenario in a pediatric manikin.   "
54502|NCT02572219|"     Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a     nutraceutical preparation on early markers of cognitive impairment, in patients affected by     arterial hypertension.   "
54503|NCT02572206|"     The primary goal of the present study is to evaluate the utility of mGluR5 binding as     measured by PET as a biomarker of the CNTNAP2 mutation and related /mTOR kinase pathway     dysregulation.   "
54504|NCT02572193|"     This is a study of an investigational surgical procedure for the treatment of achalasia the     inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM     procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being     performed to determine if patients can go home on the same day as their procedure.   "
54530|NCT02571855|"     The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or     amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of     ACT-541468 following multiple ascending doses in healthy adults and following single     ascending doses in healthy elderly subjects when administered in the morning. The safety, PK     and PD of ACT-541468 will also be assessed after repeated evening administration of a     selected dose in both healthy adults and elderly.   "
54505|NCT02572180|"     This study aims towards investigating the efficacy of a near-infrared spectroscopy     (NIRS)-based neurofeedback training in a virtual reality (VR) classroom in schoolchildren     with attention-deficit/hyperactivity disorder (ADHD). The investigators are especially     interested in the training's impact on academic performance, executive functioning (EF) and     behavioral ADHD symptoms. Furthermore, the investigators aim at examining the influence of     teachers' instructional behavior on children with ADHD's learning in a short virtual reality     classroom scenario. Several studies provide evidence that poor academic achievement in ADHD     is mainly due to impairments in EF and ADHD behavior (e.g., Frazier, Youngstrom, Glutting, &     Watkins, 2007; Miller et al., 2013). Furthermore, studies show that these factors are related     to neurophysiological characteristics found in electroencephalographic (EEG) or functional     NIRS (fNIRS) examinations (e.g., Barry, Clarke, & Johnstone, 2003; Barry, Johnstone, &     Clarke, 2003; Loo & Barkley, 2005; Negoro et al., 2010). Neurofeedback trainings aim at     improving these neurophysiological as well as cognitive-behavioral deficits (Gevensleben,     Moll, Rothenberger, & Heinrich, 2014), and are expected to improve academic performance in     children with ADHD accordingly. Training in a VR classroom, from the investigators'     perspective, facilitates generalization of self-regulation competences to real-life academic     situations and at the same time increases the effort invested into the training compared to a     training in 2D settings. Consequently, training in a VR classroom is hypothesized to lead to     greater improvement in academic performance, EF and a greater decrease of ADHD symptoms than     a training in a 2D setting. Moreover, the investigators hypothesize that these effects are     more pronounced in children who receive a NIRS-based neurofeedback training compared to     children receiving a biofeedback training based on an electromyogram (EMG).   "
54506|NCT02572167|"     The purpose of this study is to assess the safety profile and antitumor activity of     brentuximab vedotin administered in combination with nivolumab in patients with relapsed or     refractory Hodgkin lymphoma (HL)   "
54507|NCT02572154|"     In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while     etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals'     studies, several studies have underlined the importance of sperm quality for a normal embryo     development. In human, epidemiological studies have demonstrated that several male risk     factors have effects on development (male mediated development toxicology). However, few     studies have explored sperm DNA fragmentation on embryo development but after in vitro     fertilization. In natural pregnancy only rare studies have been performed but with different     populations definitions and different methods of sperm exploration. In this context sperm DNA     fragmentation exploration appears justified. The present study purpose to conduct a case -     control study in order to research paternal role in RPL.   "
54577|NCT02571244|"     The study is a preliminary research aimed to compare the effectiveness of motivational     interview (MI), Personalized text messages (TM) and usual care for outpatients, with focus on     smoking cessation as the main outcome. Smokers patients receive brief interventions and     nicotine replacement therapy during the hospitalization. After hospitalization discharge     smokers will be allocated in a intervention or control arm. In the first and third months,     after randomization, the patients will be contact to smoke abstinence assessment.   "
54620|NCT02570685|"     This randomized controlled study will examine the effects of different interpersonal     gratitude journals compared to a neutral control journal on psycho social outcomes.   "
54508|NCT02572141|"     BACKGROUND:      In patients with high risk stage II and stage III colon cancer (CC), curative surgery     followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard     treatment. However, 20 to 30 % of these patients will develop distant metastasis, which     ultimately result in death. Perioperative chemotherapy is a promising strategy with potential     benefits that could be more effective at eradicating micrometastases. Moreover, shrinking     tumor before surgery not only facilitate removal of all the tumor by the surgeon but also     reduce tumor cell spreading during the procedure. With recent advances in radiology,     preoperative computed tomography is a robust method for measuring the depth of tumor invasion     and identifying the CC patients with poor prognosis, who may benefit from perioperative     chemotherapy. The investigators conducted the present randomized study to explore whether     perioperative chemotherapy with FOLFOX or CAPOX regimens compared with postoperative     chemotherapy could improve disease-free survival in patients with radiologically staged,     locally advanced, but resectable colon cancer.      OBJECTIVE:      The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy     with FOLFOX or CAPOX regimens compared to postoperative chemotherapy in patients with locally     advanced colon cancer. Secondary objectives are efficacy in terms of R0 resection rate,     overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and     tolerability of perioperative therapy and postoperative complications.   "
54509|NCT02572128|"     The investigators studies will compare iron, respectively iron and zinc bioavailability from     fortified rice produced from different fortification techniques using stable isotopic labels.     Study 1 aims to compare the iron bioavailability from hot and cold extruded rice, in Study 2     the iron and zinc bioavailability from rice using one coating technique and hot extrusion     will be compared.   "
54510|NCT02572115|"     The purpose of this randomized controlled trial is to test the use of an emergency button     that allows patients to jump the telephone waiting line at the out-of-hours primary care in     two regions in Denmark if they perceive their illness as acute and severe.   "
54511|NCT02572102|"     To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.   "
54512|NCT02572089|"     To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose     of naloxone administrated intramuscular and to identify an appropriate intranasal dose that     could achieve systemic exposure comparable to an approved parenteral dose. To also determine     the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to     determine the safety of intranasal naloxone with respect to nasal irritation.   "
54513|NCT02572076|"     The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a     poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.   "
54514|NCT02572063|"     The overall objective of the study is to stratify a frailty population based on nutrients     profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low     molecular weight metabolites in urine and plasma) at baseline.   "
54515|NCT02572050|"     Designed as a single arm multi-center prospective phase II trial, which evaluates the number     of dissected lymph nodes in the N2-area as a surrogate parameter for adequate D2     lymphadenectomy in robotic distal gastrectomy (RDG) for clinical stage II or III gastric     cancer.   "
54516|NCT02572037|"     An observational study on the effect of new classification for premature ejaculation.   "
54561|NCT02571452|"     The purpose of this study is to determine whether a brief, behavioral treatment for insomnia     is effective in addressing social and occupational functioning and overall health among     Veterans with insomnia disorder.   "
54517|NCT02572024|"     Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These     patients are at a clearly increased risk for end organ damage and mortality. Furthermore,     arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary,     metabolic, and sympathetic factors. However, the current treatment modalities have not been     optimal in targeting the compensatory changes in sympathetic nervous system function and new     strategies have been warranted.      Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH     that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT     both long-term safety and efficacy in a large-scale, randomized, double blind, controlled     trial has been shown. However, the trial design and BAT methodology resulted in that the     first generation Rheos® system did not achieve the prespecified endpoints for short-term     safety and efficacy.      Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been     developed to address these limitations although randomized, double blind, controlled clinical     trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European     Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension,     carotid baroreceptor stimulation is mentioned as one of the options to treat resistant     hypertension.      Based on these data the aim of this randomized, double-blind, parallel-design clinical trial     is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as     well as arterial and cardiac function and structure using non-invasive high technology     methodology, in a Nordic multicentre study.      This study will include 100 patients with RH (20 from Helsinki). Eligible patients are     between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or     more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after     witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs     preferably including a diuretic), with no changes in medication for a minimum of 4 weeks     prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric     illness, severe cardiovascular disease, or any complication that is a risk to the planned     surgery are exclusion criteria.      The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood     pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end     points are to test whether BAT reduces home blood pressure during follow-up compared to     continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up     compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured     as eg. baroreflex sensitivity and heart rate variability.   "
54518|NCT02572011|"     Lower limb amputees have reduced joint mobility and strength which negatively influence an     individual's ability to maintain balance. Individuals with lower limb amputation also have an     increased fear of falling and reduced social participation because of this fear. Improving     balance ability, reducing falls and fear of falling through effective balance training     interventions would have a number of socio-economic benefits. The aim of the current study is     to investigate whether taking part in a games console based-balance intervention, improves     balance ability in individuals with lower limb amputation.   "
54519|NCT02571998|"     The primary objective of this study is to evaluate the safety and efficacy of Omiganan     (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in     female subjects with moderate to severe inflammatory acne vulgaris.   "
54520|NCT02571985|"     The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect     confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac     Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular     Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and     iliac aneurysms   "
54521|NCT02571972|"     This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and     functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections     in non-responders with wet age-related macular degeneration.   "
54523|NCT02571946|"     The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the     agent showed clear survival benefit in two randomized phase III trials, the benefit was     modest and response rate was just a few percent. Therefore, other loco-regional modalities,     like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC),     and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including     portal vein tumor thrombosis (PVTT).      With the advancement of conformal RT techniques, RT was actively applied in HCC, especially     in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose     and tumor response rate. RT dose, however, is frequently limited because the complications     (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity,     etc.) are also closely related with higher exposed RT dose.      Proton beam has characteristic depth-dose distribution contrast to photon, the Bragg peak.     The advantage of this dose distribution could be more highlighted in HCC management, because     of the weakness and maintenance importance of liver function itself in HCC patients. In fact,     the superior results of proton beam therapy in HCC were constantly reported in several groups     as prospectively as well as retrospectively.      In those background, the investigators planned the present study to evaluate the efficacy and     safety of proton beam therapy in HCC patients combined with PVTT.   "
54524|NCT02571933|"     This study evaluates the face validity and cultural acceptability of the Faces Pain Scale -     Revised in pediatric patients treated at Mbingo Baptist Hospital, Northwest Province,     Cameroon. Participants from the four major language/cultural groups evaluated at the hospital     with a complaint of pain will trial the Faces Pain Scale - Revised and then undergo cognitive     interviewing to assess comprehension and clinical accuracy.   "
54525|NCT02571920|"     Describe the proportion of patients who underwent cardiac surgery in France and benefiting     from a monitoring cardiac output, describe the use of positive inotropic and vasoactive     agents for cardiac surgery patients operated (type of catecholamines, their duration),     describe the fluid replacement and transfusions of first 24 hours, describe the incidence of     postoperative complications in patients undergoing cardiac surgery.   "
54526|NCT02571907|"     The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith®     Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available     Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.   "
54527|NCT02571894|"     The main objective of this randomized controlled trial is to test the association between     standard cardiac risk factors, biomarkers and parameters of echocardiography,     electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent     occurrence, frequency and severity of clinical or subclinical cardiotoxicity (outcome) within     and between-groups, before start of chemotherapy, during treatment and at 1, 5, and 10 years     after the completion of the chemotherapy among women with early breast cancer.   "
54528|NCT02571881|"     Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may     further impair bowel function. The aim of the present study was to evaluate if     oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients     undergoing caesarean section.   "
55612|NCT02557711|"     The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound     elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/     ARFI imaging in spasticity evaluation of stroke patients.   "
54531|NCT02571842|"     Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and     largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline     for the care of kidney transplant recipients has concluded that there are no definite     strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney     is common and may contribute to graft loss, in particular, if cresentic formation, extra- or     endocapillary proliferation were presented in kidney pathology. Herein, the investigators     assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently     decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the     investigators speculate that rituximab may have potential effect to reduce circulating     polymeric forms of IgA and slow progression of recurrent IgAN.   "
54532|NCT02571829|"     The purpose of this study is to determine whether ribociclib are effective and safe in the     treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).   "
54533|NCT02571816|"     The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in     subjects with mild and moderate hepatic impairment to matched healthy subjects with normal     hepatic function.      This study will also assess the safety and tolerability of single-dose ASP2215 in subjects     with mild and moderate hepatic impairment and matched control subjects.   "
54534|NCT02571803|"     The aim of the study is to determine, wheather strict dietary intervention with the use of     the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary     atherosclerotic lesions assessed witch coronary computed tomography.   "
54578|NCT02571231|"     The trial is a pilot study performed in the NICU's at Oslo University Hospital and Haukeland     University Hospital preparing a multi-center randomized, controlled unblinded cross-over     study, comparing high frequency ventilation (HFV) with and without volume guarantee (VG).   "
54579|NCT02571218|"     In this study, the investigators aim to identify and characterize, by means of an EnSite     Velocity Research Software, the electrophysiological characteristics of substrates that     sustain AF in patients with persistent AF and to test whether ablation of such     patient-specific substrates might improve the acute and long-term success of conventional     catheter ablation therapy.   "
54535|NCT02571790|"     The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise     of quality of life when using methods of relaxation combined with virtual reality with     patients suffering from generalized anxiety disorder in comparison of the effect of     traditional relaxation therapy. Observe and evaluate the effect of perceived presence in     synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic     efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of     generalized anxiety disorder.      It is a comparative, randomized, two groups study (29 in each group):        -  Relaxation optimized virtual reality        -  Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7          relaxing sessions (with or without virtual reality epending on the group). Each session          lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive          trials, in order to avoid cyber sickness in the virtual reality group.      Expected results: a measurable therapeutic improvement produced by the combination of     relaxation and virtual and its additional effect when compared to the traditional treatment.      Measurements of variables and therapeutic effects will be carried out with psychometric     measures.      The creation process of the relaxing virtual environments has already been completed. The     virtual environments are ready for use.      The apparatus needed and in our possession include:        -  A laptop for generating virtual environments        -  A stereoscopic display        -  Apparatus for physiological measurements   "
54536|NCT02571777|"     The purpose of the trial is to evaluate the efficacy and safety of two different doses of     QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149     doses (QMF149 150/160 μg and QMF149 150/320 μg via Concept1 in poorly controlled asthmatics     as determined by pulmonary function testing and effects on asthma control.   "
54537|NCT02571764|"     Children with moderate acute malnutrition will be recruited in order to receive an     intervention which consists in the consumption of a single serving of SF-cookies daily,     7-days a week for 12 months and 12 educational sessions on health and nutrition.   "
54538|NCT02571751|"     Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive     Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to     Augmentation Mammaplasty for Purpose of Cosmetic Surgery.   "
54539|NCT02571738|"     A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further     Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment     of Chronic Diabetic Foot Ulcers   "
54540|NCT02571725|"     Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten     percent are attributed to hereditary syndromes, most commonly the result of mutations in the     breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results     in the inability to repair double-stranded breaks in DNA. Treating these tumors with     poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors results in the specific     killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment of     ovarian cancer patients with PARP inhibitors has resulted in improved progression free     survival (PFS), but not overall survival (OS). It's not completely understood why this is the     case, but some preclinical studies using ovarian cancer models in mice have suggested that     combining PARP inhibitors with immune system modulators like T cell checkpoint inhibitors     improves long-term survival.      Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination     of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody     Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.   "
54541|NCT02571712|"     A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in     Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently     responsive to topical beta-blocker or prostaglandin analogues.   "
54542|NCT02571699|"     The aim of this study is to determine the minimum effective volume of LA in 90 % of patients     (MEV90) required for US-guided subgluteal sciatic nerve block.   "
56086|NCT02551497|"     This is a double-blind, randomised, placebo-controlled 3 period study to evaluate the     interaction between a drug and CNV1014802 in healthy male and female subjects. It is planned     to enrol 36 subjects.   "
54544|NCT02571673|"     This study is being done to understand how survivors of head and neck cancer think they can     make HN-STAR (the Survivor Self-Assessment, the survivorship clinic experience, and the     Survivorship Care Plan the best it can be. Once the investigators have your input and input     from other survivors, they can make changes to HN-STAR, so that they can test this tool in a     larger study. The larger study will tell them whether using HN-STAR improves the care of head     and neck cancer survivors.   "
54545|NCT02571660|"     Asthma is a disease that represents a public health problem worldwide, there are several     barriers, especially in pediatric patients with this disease, them, prevent the adequate     control of their condition, in addition every day there are new processing aids for this     entity; within these novel research we founded the relationship between decreased vitamin D     serum levels and his role in the regulating of the immune response, also this relationship in     the pathophysiology of this disease and responses in the event of infectious diseases of the     respiratory tract which can exacerbate symptoms in pediatric patients. We have been some of     clinical trials with the aim of improving serum levels of vitamin D in asthmatic patients,     however, these studies have different sources of bias and thus far there is no solid evidence     that favors or denies the relationship between asthma and vitamin D, this paper aims to help     generate this evidence to improve clinical management of these patients and their lung     function and increase the free time crisis.      In this trial two study groups which are divided for each of the interventions described     below:      Group low supplementation dose: 1 tablet of 400 IU was administered every 24 hours via oral,     regardless of time or if it is before or after food, preferably in the morning to improve     adherence to treatment, will be completed one year of treatment without suspension.      Group high supplementation dose: 1 tablet of 1600 IU should be administered every 24 hours     via oral, regardless of time or if it is before or after food, preferably in the morning to     improve adherence to treatment, will be completed one year of treatment without suspension     thereof.   "
54546|NCT02571647|"     Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly.     Yet the visual deficit impacts the quality of life, the evolution of the autonomy and     psycho-behavioral disorders in cognitive diseases. The main objective of the study is to     evaluate the prevalence of visual disorders among elderly patients at consultant outpatient     center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary     objectives are to describe ophthalmological diseases detected and taken into the proposed     ophthalmic load, to determine if there are associations between eye diseases and cognitive     disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation     to determine the cognitive profiles and geriatric evaluation and ocular pathological,     depending on the assessment of arterial stiffness. The results of this study will build a     testing strategy to promote access of older patients with cognitive impairment to vision     care.   "
54547|NCT02571634|"     The purpose of this study is to evaluate the effectiveness, feasibility and safety of     intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to     produce anxiolysis and improve patient comfort during and after radiofrequency ablations of     the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to     be feasible and safe for use during procedures, future larger scale studies can be done.   "
54548|NCT02571621|"     Retrospective evaluation of a database of ETC routine uses during general anaesthesia.   "
54549|NCT02571608|"     Type II Diabetes Mellitus patients having surgery who adhere to their regular scheduled     metformin dosing and take this medication on the morning of surgery will have better glycemic     control peri-operatively and potentially suffer less morbidity compared to individuals taking     a placebo.   "
54550|NCT02571595|"     Sleep problems, such as insomnia, are more frequent and intense in individuals living with     HIV. These sleep difficulties can increase the difficulties in thinking and concentrating.     Digital cognitive behavioral therapy for insomnia (dCBT-I) is a computer-based treatment     intervention that provides strategies to improve sleep. This intervention has been shown to     improve sleep and daytime function (concentration, productivity) in people with insomnia.     However, the effects of this intervention in people living with HIV are unknown.   "
54551|NCT02571582|"     Advanced Pulmonary Disease (PAD) is a condition that affects countless individuals around the     world. Patients are often functionally very limited, with premature death, which is due to     the disease itself or its complications. Currently, there are numerous monitoring centers of     these patients to increase survival, reduce costs and humanize care in these patients.   "
54552|NCT02571569|"     Investigate the safety, tolerability and pharmacokinetics of BAY 1093884 after Intravenous     (IV) and subcutaneous (SC) administration of increasing single doses.   "
54553|NCT02571556|"     To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate     ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients     having undergone cataract surgery with implantation of a posterior chamber intraocular lens     (IOL)   "
54562|NCT02571439|"     The TAP is a space between the muscle layers of the abdominal wall that houses nerves     supplying the abdominal skin. Injecting the local anesthetic ropivacaine into this space will     block these nerves and prevent pain following c-section. The investigators will compare two     different approaches to injecting the local anesthetic in this space. Conventionally, the     block is done after surgery is completed and the abdomen is closed. The anesthesiologist     introduces a needle through the abdominal wall skin under ultrasound guidance to reach the     TAP space and the drug is injected. Since the TAP layer is one of the deeper layers of the     abdominal (belly) wall and is closer to the inside of the abdomen than to the outside (skin),     injecting from the inner aspect of the abdominal wall during the surgery is easier and     quicker to perform than the conventional block and does not require ultrasound guidance as     there is no risk of injury to abdominal organs like the liver.      With this research the investigators attempt to prove that surgically administered TAP blocks     take 25% less time to perform compared to the conventionally administered TAP block for post     cesarean section pain relief. Surgical TAP blocks are also more cost-effective as in addition     to reduced OR time, they are safer and do not require skilled operator and specialized     equipment. Secondary outcomes will include total time spent in the Operating room, presence     and severity of postoperative pain, time to first request for pain medication, total     postoperative narcotic consumption in 48 hours after surgery and side effects.   "
54554|NCT02571543|"     During natural cycle in vitro fertilisation, no gonadotropin stimulation is used to stimulate     oocyte production. Ovulation is induced with HCG (human chorionic gonadotropin) and the     follicle is retrieved 36 hours later.      In this study the patient in the intervention group will receive Ibuprofen as a study     intervention beginning at the same time as the HCG injection. The treatment dose will either     be 400mg every 8 to 12 hours or 800mg every 8 to 12 hours until the follicle retrieval,     totalling 5 tablets. Instead of the usual time period of 36 hours, the follicular punction     will occur after 42 hours. Should the oocyte still be accessible after this time period, then     it is proven that Ibuprofen delays ovulation. In this case the patient will continue the     regular NC-IVF treatment cycle.      The study design is a admissible two-stage design. During stage 1, 8 cycles in 8 patients     will be examined. Should it be the case that after these 8 patients have completed a cycle, 4     or more show a positive treatment effect from the Ibuprofen intake, then the study will     continue to stage 2 with 17 more more patients, totalling 25.      Should it be the case however, that after 8 patients, 3 or less show an effect of the     Ibuprofen intake, then the study will be stopped prematurely for futility. The study     intervention will be increased to 800mg of Ibuprofen and the study will recommence with 8     more patients.      A control group will consist of women undergoing intrauterine insemination (IUI) or timed     sexual intercourse (TSI). 42 hours after Beta-HCG injection, an ultrasound examination will     be performed in order to determine the number of remaining follicles in the ovary. This     examination is to verify and control the proposed time limit of 42 hours.   "
54555|NCT02571530|"     The purpose of this study is to evaluate the safety of administering a single dose of     trastuzumab into the artery for the treatment of brain metastasis(es) from HER2/neu positive     breast cancer.      This study will try to determine the best tolerated single dosage of trastuzumab administered     into arteries by gradually increasing the dosage given to participants as the study     progresses. Early participants will receive a dosage of 1 mg/kg. As more participants enroll     into the study, this single dosage will be increased at designated levels up to 8 mg/kg, if     it's determined to be safe to increase.      Trastuzumab is a type of antibody, which is a protein used by the body's immune system to     fight against pathogens such as bacteria and viruses. This antibody binds to cell receptors     known as the HER2/neu tyrosine kinase receptor. These receptors are expressed in certain     cancer subtypes such as breast cancer. By blocking signaling through this HER2/neu receptor,     trastuzumab can slow down or stop the over-expression of the HER2/neu protein.     Over-expression of HER2/neu has been shown to play a role in the development and progression     of certain types of breast cancer. Therefore, by slowing down or stopping the expression of     HER2/neu, investigators hope to slow down or stop the growth of metastasis(es) and increase     the responsiveness to therapy.   "
54556|NCT02571517|"     The purpose of this study is to to demonstrate that a 7-day course of systemic     glucocorticoids decreases the inflammatory activity of moderate or severe bronchiolitis in     paediatric patients compared to the standard treatment. To evaluate the morbidity (regarding     to the clinical course: Intensive Pediatric Unit Care unit (PICU) admission, mechanical     ventilation, ionotropic support, nosocomial infection, rescue therapy for respiratory     failure; duration of PICU stay and hospitalization; and exitus) between the treatment and the     control groups.   "
74787|NCT02306863|"     This study will evaluate whether whole-body vibration applied over a 12-week period is     effective in treating motor symptoms of Parkinson's disease.   "
54557|NCT02571504|"     Cognitive deficits in HIV reflect degraded brain network functioning that may be amenable to     remediation through cognitive training. In this sub-study, we will make use of     Plasticity-based Adaptive Cognitive Remediation (PACR), which applies well-understood     techniques derived from brain plasticity and implicit/procedural/perceptual learning to     improve the speed and accuracy of information processing, with exercises that are designed to     drive generalized improvements. Simultaneously, these exercises heavily engage     neuromodulatory systems to re-establish their normal control over learning and memory. As an     individual restores these degraded abilities through intensive procedural learning, the     encoding of naturalistic information significantly improves, and all resulting declarative     memory and cognitive functions based on the quality of that incoming information necessarily     improve as well, leading to improvement that generalizes beyond the trained tasks.      A subset of 80 HIV+ individuals will undergo eight weeks of PACR to determine its feasibility     and appropriateness for people with mild cognitive difficulties related to HIV infection. The     results of this study are expected to be pivotal in generating data to create an optimal     training program aimed at stabilizing or improving brain function in HIV infected individuals     experiencing cognitive decline.   "
54558|NCT02571491|"     Comparison of the Efficacy of ketamine measuring the total consumption of morphine in     pediatric patients with idiopathic scoliosis   "
54559|NCT02571478|"     The psychological health of military members is a critical element of force health protection     and readiness. Frequent deployments and high operations tempo at home strain the     relationships and families of today's military more than ever before (e.g., Karney & Crown,     2007). Since 2001 the likelihood of divorce in the Air Force increased with the number of     days that Airmen were deployed (Karney & Crown, 2007). Distressed relationships not only     adversely affect members' adjustment and readiness (e.g., Hoge et al., 2006) but also are     centrally implicated in suicides (i.e., relationship problems are the precipitating event in     51% of Air Force suicides, Kindt, 2009) and domestic violence (Pan, Neidig, & O'Leary, 1994).     Unfortunately, traditional sources of marriage counseling available to service members are     largely underutilized. The MC brings a fresh perspective that helps normalize relationship     help-seeking and in turn reach larger numbers of distressed couples early. The partnering of     MC and integrated primary care appears to be an ideal combination of behavioral health     innovations that has the potential to measurably enhance relationship health for the military     services.   "
54560|NCT02571465|"     To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume     and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg     Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.      Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the     transition from controlled to spontaneous breathing in cardiac surgery patients   "
63201|NCT02458404|"     This study will help determine the effect of varied estradiol levels on the uterine lining in     healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.   "
54563|NCT02571426|"     It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears     more pronounced in children. However, the mechanisms for this effect is unknown and it is not     clear if the commonly used anesthetic propofol does the same. In this study the investigators     want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a     pediatric setting and also investigate humoral changes induced by these anesthetics.   "
54564|NCT02571413|"     Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the     treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS     administration was created to decrease workload of health care professionals. The aim of this     study is to compare the achievement of the children with AR in using INCS between the group     which were instructed by animated cartoon-aided teaching or oral presentation without     demonstration.   "
54565|NCT02571400|"     Post-surgical opioid prescribing intended for the short-term management of acute pain may     lead to long-term opioid use, and its associated harms. This study was undertaken to     determine the prevalence of prolonged post-surgical opioid use, and patient-related factors     associated with prolonged post-surgical opioid use.   "
54566|NCT02571387|"     The purpose of this study is to evaluate the efficacy of a daily 12-month computerized     mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED)     on: impulsive eating, motivation toward exercise, and weight loss.   "
54567|NCT02571374|"     This is a double blind randomized trial in which patients with colorectal cancer undergoing     surgery will be selected to receive either a symbiotic formulation or placebo. The     researchers will compare incidence of surgical site infection between the study groups.   "
54640|NCT02570425|"     This study is conducted to assess the ease of device mastery of a placebo SYMBICORT     TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals     in-training (HCP).   "
54568|NCT02571361|"     Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group     clinical trial      Trial acronym: PANSAID      Background: Effective postoperative pain management is essential for the well-being and     rehabilitation of the surgical patient. No gold standard exists after total hip     arthroplasty (THA) and combinations of different non-opioid medications are used with     virtually no evidence for additional analgesic efficacy compared to monotherapy.      Objectives: The objective of this trial is to investigate the analgesic effects and safety of     paracetamol and ibuprofen and their combination in different dosages after THA.      Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400     mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and     ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.      Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised     computer-generated allocation sequence and allocation concealment with varying block size and     stratification by site. Blinding of assessor, investigator, caregivers, patients, and     statisticians.      Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the     first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004     (two-sided) and a type 2 error rate of 0,10.      We preplan the following sub-studies:        1. A re-analysis of benefit outcomes (pain and opioid consumption) with respect to the          following sub-groups: sex, age, ASA-score, type of surgery (uncemented, cemented, or          hybrid), surgical site (posterior approach vs. anterolateral approach) and anaesthetic          technique (general anaesthesia vs. spinal anaesthesia)        2. A re-analysis of harm (adverse events and opioid related side effects) with respect to          the following groups sex, age, ASA-score anaesthetic technique (general anaesthesia vs.          spinal anaesthesia) and opioid consumption (in the intervention period).        3. Longer follow-up than the specified 90 days (1 year)        4. An analysis of the association between VAS-scores and opioid consumption        5. Time-to-event analyses regarding use of PCA-morphine        6. An analysis of the association between preoperative analgesic use and pain/morphine          consumption        7. An analysis of the individual patients: how many will achieve no worse than mild pain          (NRS<3) More sub-studies may be performed post-hoc and they will be clearly identified          as such.   "
54569|NCT02571348|"     This study is intended to investigate the optimum interval between micro-osteoperforations to     accelerate orthodontic tooth movement. Overall, the investigator will be comparing the rate     of tooth movement between micro-osteoperforated site and non micro-osteoperforated site.     Next, the investigator will be comparing the rate of orthodontic tooth movement for     micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the     investigator will be evaluating the pain intensity and impact of pain on quality of life     during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the     investigator will be comparing the rate of orthodontic tooth movement between maxilla and     mandible.      The significance of the outcome is to determine optimum recommended interval for     micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding     out the optimum interval, the investigator can come with a recommended interval of     micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth     movement.   "
54570|NCT02571335|"     Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system,     accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With     chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS)     progressively develop impaired functional capacity and show reduced physical activity and     cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS     are therefore to increase levels of activity and participation leading to increase     independence of the participants. In general exercise ranges from passive physiotherapy-based     interventions to submaximal endurance training sessions. Current recommendations advise pwMS     that exercise should be matched with the individual performance capacities. Exercise training     in pwMS then has the potential to target and improve many components outlined in the     ICF-model.      Cytokines and neurotrophic factors have received increased attention in MS research and     addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal     regeneration linking the effects of exercise with MS pathogenesis. Data show positive     connections between elevated neurotrophin concentrations, induction of neuroplasticity,     recovery of the motor and cognitive functions and the applied training intensities.     Similarly, intensive and progressive exercise bouts seem to have greater benefits on     cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with     dementia. Therefore, specific exercise prescriptions may be necessary for targeting the     specific impairments also in pwMS.      This study aims to evaluate two different training modalities (intensive versus normal) in     pwMS. It is expected that both modalities will improve cardiorespiratory fitness and     cognitive functions in pwMS. Based on the findings that higher training intensities     facilitate greater benefits, it is expected that pwMS will tolerate the intensive training     intensities and show positive connections to elevated neurotrophin concentrations.      The results will to help to clearer understand the benefits of each type of exercise conveyed     for pwMS and will assist in the development of patient-specific exercise prescriptions.   "
54571|NCT02571322|"     The purpose of the study is to determine the effect of whole-body vibration (WBV) on body     composition, physical fitness, and quality of life.   "
54587|NCT02571114|"     A single site, blinded, randomized, controlled study designed to examine the glycemic and     metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and     females.   "
54588|NCT02571101|"     The purpose of this study is to evaluate the safety and efficacy of on-demand therapy with     CDFR0812-15/25mg and CDFR0812-15/50mg compared to on-demand therapy with single-drug     administration of Clomipramine HCl 15mg in Korean Male Patients Diagnosed with Premature     Ejaculation   "
55774|NCT02555592|"     The purpose of this study is to identify the treatment outcomes of surgical resection with     sequential adjuvant chemotherapy and radiotherapy in patients with stage IIIA non-small cell     lung cancer and N2 disease at only the sub- or para-aortic level.   "
54572|NCT02571309|"     Primary aim: Evaluating the effect of Asthmatuner on patients´ self-reported asthma control     test (ACT/C-ACT)compared with conventional asthma management.      Secondary aim: Evaluating patients´ health-related quality of life (HR-QoL) medical adherence     by using Asthmatuner compared with conventional management.      Total sample size: Stratified study population consisting of 43 females and males with     diagnosed asthma at the age of at least 6 years pediatric specialist care and 43     females/males in primary care.      Study design: This is a multi-centre, blinded, randomized controlled, cross-over trial over     to at least 16 weeks.      Subjects: Two stratified groups of participants with uncontrolled asthma will be recruited;     (1) children and adolescents from Astrid Lindgren's Children's Hospital, Karolinska     University Hospital, and (2) adolescents and adults from the primary health care sector in     Stockholm, Sweden. The asthma control test (ACT/C-ACT) will be applied for evaluation of     asthma control, a score less than 20 will be required for inclusion.      Intervention: Asthmatuner is an app supporting self-management evaluating symptoms and lung     function with external spirometry. The app gathers the information to define patients´ asthma     control. Subsequently, Asthmatuner provides the patient with a treatment recommendation based     on the individual treatment plan.      Procedures: Participants are randomized (1:1) into the one of two-arms of asthma     self-management with Asthmatuner - conventional or conventional - Asthmatuner. Questionnaires     will collect information about asthma control, HR-QoL, Medicine adherence report scale (MARS)     and history of medical health concerning health care utilization and personal costs and     income.      Analysis: The study hypothesis will be tested by examining difference in patients´ change in     asthma control (ACT/C-ACT) and HR-QoL (PAQLQ/Mini-AQLQ). Results will be summarized at each     management period as mean scores and analysed by paired t-tests.   "
54573|NCT02571296|"     This is a randomized, double-blind, placebo-controlled study.   "
54574|NCT02571283|"     A prospective, randomized control study will be conducted to compare postoperative pain     control in a series of patients treated with either:        1. a local cocktail.        2. a local cocktail plus Exparel.        3. marcaine plus Exparel prior to wound closure following knee arthroplasty.   "
54575|NCT02571270|"     Purpose: Physical exercise exerts favorable impact on functional capacity (FC) and quality of     life (QL) in patients with heart failure (HF). It is believed that the combined aerobic and     resistance physical training (CPT) supervised by physical educator is better than only     prescription of unsupervised exercise. The aim of this study is to compare the effects of a     CPT program on the FC and QL of HF patients with reduced ejection fraction (HFREF) with the     practice medical routine prescription of regular physical activity and correlate these     findings with clinical and echocardiographic variables.      Methods: A longitudinal prospective study included 28 consecutive HFREF patients randomly     divided in two age- and gender- matched groups: Trained Group (TG, n = 17), patients     undergoing 12 weeks of supervised CPT and Non Trained Group (NTG, n = 11), patients receiving     only medical prescription to practice regular physical exercise. All patients were submitted     to clinical evaluation, transthoracic echocardiography, Cooper walk test and QL questionnaire     before and after the study protocol. Student t test or Mann-Whitney test were performed for     groups comparison and correlation tests for the same group variable associations.   "
54580|NCT02571205|"     Observational study of clinical outcomes for testosterone treatment of pubertal delay in     Duchenne Muscular Dystrophy is a single centre observational study that aims to follow the     progress of 20 adolescents with Duchenne Muscular Dystrophy (DMD) and delayed puberty who are     treated by the Newcastle muscle team, as they are treated with testosterone to induce     puberty. The participants will all be treated with the standard stepwise regimen of     testosterone injections every 4 weeks and data will be collected to help determine the     effectiveness and tolerability of the current treatment regimen. The investigators will use     the data to explore the effect of testosterone on pubertal development, growth, muscle     strength and function, bone mineral density and body composition and characterise any side     effects. Semi-structured interviews will also be carried out to learn the boys' views on the     tolerability of the regimen. The study will last up to a maximum of 27 months in total for     each participant, but may be less if they are happy with pubertal development before this     time. It is important to do this study because from the investigator's limited experience in     this group, testosterone treatment seems to be well liked and tolerated but the best     treatment regimen to use remains unknown and there is no current consensus. It is not     currently part of the standard of care in DMD but it would be important to include it if this     study can show that it is an effective treatment for pubertal delay.   "
54581|NCT02571192|"     The purpose of this study is to determine how SHP626 is absorbed and excreted from the body     in healthy males.   "
54582|NCT02571179|"     Physiological changes during pregnancy are known to affect the pharmacokinetics of many     drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in     pregnant patients has not been established. The investigators studied pharmacokinetics of     intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal     safety after administration.   "
54583|NCT02571166|"     The purpose of the study is to determine the safety of HSV529 vaccine in healthy volunteers     with HSV infection and to determine if administration of the HSV529 vaccine increases the     immune response in genital skin.   "
54584|NCT02571153|"     There are evidences that intraoperative administration of low doses of ketamine may     contribute to control the postoperative pain by acting on the N-methyl-D-aspartate (NMDA)     channel, reducing the effects related to the tolerance and hyperalgesia induced by opioids.     This study aims to evaluate the effects of administration of this agent not only as an     analgesic but also its role in the quality of recovery from anesthesia, which includes     observation of emotional, psychological and physical aspects. Patients who were scheduled to     undergo total intravenous anesthesia (TIVA) for laparoscopic cholecystectomy will be enrolled     in this clinical study. After induction of anesthesia, patients will receive one of three     solutions according to the randomly selected group: ketamine 0,2 mg/kg; ketamine 0,4 mg/kg or     saline. In the recovery room and on the ward, data related to the presence of pain, analgesic     consumption, the incidence of nausea and vomiting, dizziness or hallucinations will be     recorded. The next day, the quality of recovery will be evaluated by application of the     questionnaire QoR40 (Quality of Recovery Questionnaire-40).   "
54585|NCT02571140|"     This study will have one stage consisting of multiple treatment visits. The study is designed     to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy     volunteers in various formulation. The study is also designed to assess the reproducibility     of pharmacokinetic profiles with various formulations.   "
54586|NCT02571127|"     Primary: Evaluation of improved vaginal moisture in postmenopausal women.      Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of     the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of     adherence to study treatment by patient diary, assessing the acceptability of the product and     subjective assessment of the patient as the itching and stinging / burning, beyond the safety     assessment.   "
54589|NCT02571088|"     Sickle cell disease (SCD) is the most frequent inherited disease in the world. Literature     reports that SCD patients display intolerance to exercise, important muscle weakness and     profound remodeling of skeletal muscle including amyotrophy and rarefied microvascular     network.      Because strenuous exercise induces acidosis, hemorheological alterations, endothelial     activation and oxidative stress, it constitutes a potential triggering factor of sickling and     vaso-occlusive crisis. As a consequence, physical activity is usually discouraged in patients     with SCD. However, moderate and regular physical activity seems to be not only safe but also     beneficial for SCD patients.   "
54590|NCT02571075|"     The purpose of this study is to determine if auricular acupuncture significantly reduces     post-operative pain in comparison to the standard of care. Post-operative pain score will be     collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no     pain, 10 = worst imaginable pain) up to 10 days post-operation.   "
54591|NCT02571062|"     Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of     the tablet formulation used in the clinical trials and the final marketed tablet formulation     under fed condition.      The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate     crossover study under fed condition. The 4-period sequences for the replicate design will be     TRTR and RTRT, where R designates the reference formulation and T the test formulation.     Subject will be allocated randomly to one of the two sequences of treatments according to the     randomization list.   "
54592|NCT02571049|"     Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous     DFN-11 in subjects with rapidly escalating migraine headaches.   "
54593|NCT02571036|"     This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to     evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and     preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with     advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an     expansion phase.   "
54594|NCT02571023|"     The purposes of this study are as follows:        1. to collect the largest epidemiological data of skull base trauma and analyze the related          influence factors of mortality and morbidity.        2. to establish a set of standard classification methods of skull base trauma and to          establish a standard rating scale for each type of trauma.        3. to select optimized conservative and surgical treatments of skull base trauma and to          compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.        4. to clear the epidemiological characteristics of the skull base trauma combined with          paroxysmal sympathetic hyperactivity.   "
54595|NCT02571010|"     This study aims to demonstrate that somatosensory rehabilitation of pain associated with     static mechanical allodynia has superior efficacy over placebo treatment as well as over     spontaneous changes.   "
54596|NCT02570997|"     This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study     will be conducted in two phases: a single ascending dose (SAD) phase Part A, followed by a     multiple ascending dose (MAD) phase Part B. In Part A, subjects will receive one dose of     study drug. In Part B, subjects within a cohort will receive the same dose daily for 14 days.     In both parts, sequential cohorts will be exposed to increasing doses of CT1812 in order to     identify the maximum tolerated dose (MTD).   "
54597|NCT02570984|"     This trial is a randomized, double-blind, placebo controlled trial designed to test whether     two years treatment of preschool children aged 2-3 years of age at high risk for asthma with     omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as     reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2     year observation period off study drug.   "
54598|NCT02570971|"     Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global     public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida,     followed by Hawaii and California. Equipoise exists in the medical literature regarding the     effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many     case reports attesting to its utility, the only randomized control trial (RCT) comparing     mannitol therapy with supportive care failed to show any significant benefit from mannitol     treatment for a variety of clinical outcomes. Investigators therefore propose a second,     larger RCT to test this question.   "
54599|NCT02570958|"     Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an     early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater     than 80% after surgical resection. Screening tests have made it easier to identify small lung     tumors. However, these tumors are often not visible to the naked eye, and surgeons cannot     feel them, making them difficult to precisely locate and remove. For this reason, surgeons     have become more reliant on image guided surgery for the removal of these tumors.      The standard of care for locating and removing small lung tumors is microcoil-guided     video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two     separate physicians.        -  First, patient is taken to radiology suite and radiologist inserts a microcoil near the          lung tumor        -  Second (usually occurs a few hours later), patient is taken to operating room; a surgeon          uses an x-ray arm to find the microcoil within the lung and remove it surgically.      A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were     both removed. Until this evaluation, the surgeon does not know whether the tumor has been     removed or not. While this method is safe, it is time consuming, uses staff resources, and     requires bulky equipment to complete.      In this study, we plan to develop and test a new method of identifying and removing small     lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB) Robotic     Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose of this     study is to test the safety and reliability of the ENB-RIGGS surgery in the form of a pilot     study.      ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic.     ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to     the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor,     and when viewed by the special robotic camera the tumour will fluoresce with a green hue     allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the     tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a     pathologist.   "
54609|NCT02570828|"     This is a study to evaluate thermal imaging as a technology to monitor the normal clearing of     amniotic fluid from healthy newborns and newborns suspected of having a condition called     transient tachypnea of the newborn, or TTN. Thermal images are taken using an imaging device     that attaches to an iPhone. This device, commercially known as FLIR ONE, creates a     non-identifiable image based on the heat pattern of an object. In this case, the object is a     child's chest and back. It does not emit any radiation like an x-ray does.   "
55800|NCT02555241|"     The purpose of this study is to investigate the effects of several applied behavior teaching     procedures on the use of multi-word utterances by children with autism.   "
54600|NCT02570945|"     The study population will consist of all elderly (65 and older) patients hospitalized at the     Centre hospitalier universitaire de Sherbrooke. The patients who present a     pharmacotherapeutic problem will be randomly allocated between intervention and control     groups. Practically, the relevant data will be extracted from the Electronic Medical Record     (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify     pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in     geriatrics to determine their clinical relevance and the modifications that can be made.     Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and     treating physician to establish the changes needed to optimize drug therapy. A geriatrician     will also be available to assist the pharmacist in his initial assessment for particularly     complex cases. For control patients, a CAS analysis will be conducted to identify patients     with a pharmacotherapeutic problem but there will not be a formal discussion amongst the     health care providers (usual care) and the physicians of the control group will provide usual     care to their patients. The investigators believe that it is ethical to provide usual care to     the control group since the beneficial impact on patients outcomes of the investigators'     intervention has not been demonstrated.      Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication     committee and are based on the Beers criteria with an emphasis on drugs involved in the     development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and     older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active at     the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older: i)     taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or     memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase     inhibitor or memantine are frailty indicators.   "
54601|NCT02570932|"     The purpose of this study is to analyze the potential clinical efficacy of intrathecal     administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow     mesenchymal stem cells in the treatment of patients with established chronic spinal cord     injury (LEM).   "
54616|NCT02570737|"     The RELAHP registry is a Latin-American multinational, multicenter, prospective observational     registry-type cohort study, which pretends to identify clinical characteristics, clinical     course, management and outcome of all forms of pulmonary hypertension (PH).      All consecutively consented patients newly diagnosed with WHO Group I-V PH according to     specific hemodynamic criteria on right heart catheterization at the participating centers     will be enrolled. Patients will be followed six-monthly for a minimum of five years from the     time of enrollment.   "
54617|NCT02570724|"     The injection of autologous blood Blood Patch (BP) into the epidural space is the standard     treatment for headache associated with intracranial hypotension. It provokes cerebral     vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever,     sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch     made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood     patch. This alternative technique is simple to implement and does not have some of the     specific blood pressure contra-indications. The study aims at comparing the Blood Patch     group versus the HES Patch in terms of clinical efficacy , tolerance, satisfaction of the     anesthetist, ease of implementation and effect of the injection of epidural anesthesia on     cerebral blood flow within 24 hours.   "
54641|NCT02570412|"     Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.   "
54602|NCT02570919|"     The present study evaluates clinical outcomes and treatment-related toxicity following     definitive ultra-high dose external beam radiotherapy delivered with two different regimens     in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven     technology enables the implementation of ultra-high hypofractionated Image-Guided     Radiotherapy (IGRT) safely.      Prostate cancer patients classified according to the current National Comprehensive Cancer     Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate     Specific Antigen (PSA) level >10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are eligible     for this study.      Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with     state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on     normal tissue sparing and delivery accuracy via the use of devices that ensure stability and     beam location reproducibility. A rectal balloon with air filling will be used for prostate     target immobilization and anatomical reproducibility, while a urethral catheter loaded with     beacon transponders will be used to ensure set-up reproducibility and online target tracking.     Previously untreated patients with intermediate-risk prostate cancer will be prospectively     randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in a single-dose.      Patients will be followed at one month post-treatment and every 3 months for up to 12 months     (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will     focus on urinary, rectal and sexual functions and will be assessed through validated     questionnaires. Serum PSA values will be regularly acquired during follow-up. A     multiparametric MRI will be performed at baseline, 6, 12 and 24 months following     intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be     performed within 15 minutes of the first treatment, to measure early physiologic changes,     such as perfusion and ischemia, that may correlate with clinically relevant end-points.     Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic     response to therapy. The study will be continuously monitored for a minimum of 5 years. In     the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment     arms, the study will be terminated according to the stopping rule >3/first 15 patients.   "
54603|NCT02570906|"     This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate,     respiration rate, posture, and activity level compared to reference devices in healthy adult     subjects during a variety of situations including hospital room movements, talking, and a     short bout of exercise.   "
54604|NCT02570893|"     This is a multicenter, randomized, open-label, phase III trail comparing adjuvant     chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients     undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell     carcinoma.   "
54605|NCT02570880|"     This study evaluates the impact of dough fermentation times on the glycaemic index of the     ensuing breads.   "
54606|NCT02570867|"     Structural and functional brain changes of primary open-angle glaucoma patient will be     examined with fMRI. POAG patients and control group were examined with 3.0T magnetic     resonance imaging. The gray matter, white matter and cerebrospinal fluid volume images will     be obtained and analysed.   "
54607|NCT02570854|"     The study will assess the safety, tolerability and efficacy of CSJ137 in chronic hemodialysis     patients. It is hypothesized that treatment with CSJ137 may improve the level of hemoglobin     in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for     dosing with erythropoietin and intravenous iron in these patients.   "
54608|NCT02570841|"     Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds     (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in     g) immediately after to find out the exact skin temperature by which capsaicin initiates the     application pain (heat pain threshold, HPT in °C) but also the temperature by which capsaicin     does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the investigators     want to find out the mechanical pain threshold in g from topical capsaicin and to verify a     prolonged effect of capsaicin on the pain thresholds.   "
56381|NCT02547649|"     This study is designed to assess the effect of two different formulations of pneumococcal     polysaccharide vaccine on safety and immunogenicity of V114 in healthy adults 50 years of age     and older.   "
54610|NCT02570815|"     Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these     lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done     to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which     removes a large amount of lung tissue For patients with small tumours saving as much healthy     lung tissue as possible is important. Each lobe of the lung has smaller sections called     segments. When a lung cancer is in one of these segments, it is possible to remove that     segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared     to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue.      With the advances in screening technology for lung cancer tumours, an increasing amount of     very small lung cancer tumours are being found, and the demand for segmentectomy is     increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult     to view the tissue lines that separate each segment within the lobe. As a result, it is     difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of     these challenges, many patients having robotic surgery will have a lobectomy, even if a full     lobectomy is not needed.      Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent     advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to     determine which segment the tumour is located in. Once identified, the surgeon will isolate     the segment by cutting off the blood supply to that segment. Then ICG will be injected into a     vein. It is expected that the entire lung, except the isolated segment, which will remain     'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when     viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will     remove it. A pathologist will examine the excised tissue to ensure that the tumour was     removed in its entirety. Once confirmed, the surgeon will end the procedure. If the     pathologist determines that the segment removed did not contain the entire tumour, then the     surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all     participants will have the entire tumour removed from their lung.   "
54611|NCT02570802|"     The purpose of this clinical trial is to assess normal values of the cross-sectional area of     peripheral nerves and nerve roots in children and adolescents between 2 and 18 years.   "
54612|NCT02570789|"     The purpose of this study is to assess whether certain metabonomics and/or lipidomics     features in correlation with pharmacokinetics before, during and after treatment with     sunitinib or pazopanib in first line can predict toxicity and efficacy of sunitinib or     pazopanib in metastatic clear cell renal cell carcinoma patients.   "
54613|NCT02570776|"     The prevalence of H. pylori infection in Pakistan is unknown and investigators want to assess     it in dyspeptic patients utilizing UBT. At the same time investigators want to validate UBT     sensitivity and specificity in Pakistani patients   "
54614|NCT02570763|"     The current study aims to examine the safety and feasibility of utilizing tDCS to enhance     affect-laden episodic memory consolidation among adults with co-occurring alcohol use and     anxiety disorders who have recently undergone detoxification as a step toward the     translational clinical application of this approach.   "
54615|NCT02570750|"     The main purpose of this study is to assess the effect of smoking status on the success of     Etanercept therapy in patients with moderate-to-severe psoriasis.   "
54621|NCT02570672|"     Frailty is a geriatric syndrome which leads to poor health outcomes in older adults, such as     falls, disability, hospitalization, institutionalization, and death. Due to the dramatic     growth in the U.S. aging population and the health care costs associated with frailty     (estimated at more than $18 billion per year), frailty is a major health care problem. There     has been little research into potential pharmacologic interventions that would delay or     reduce the incidence of frailty. Thus, the major goal of this study is to test metformin as a     novel intervention for the prevention of frailty. The investigators propose that     diabetes/insulin resistance and inflammation are major contributors to frailty, and that the     use of metformin to modulate diabetes/insulin resistance and inflammation will prevent and/or     ameliorate the progression of frailty.   "
54622|NCT02570659|"     A randomized controlled trial (RCT) to investigate the effect of a information video,     consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder     (WAD).   "
54623|NCT02570646|"     Using a single-arm trial design, this study will examine the feasibility and acceptability of     evaluating QuitAdvisorDDS, a clinical decision support software application designed to     facilitate implementation of evidence-based tobacco treatment interventions into the dental     setting. The study will examine the feasibility and acceptability of evaluating the impact of     the QuitAdvisorDDS tool on patient outcomes related to tobacco use and cessation attempts as     well as provider knowledge, attitudes, and practices regarding tobacco treatment.     Practitioners (dentists and hygienists) will complete surveys at baseline and follow-up,     while patients will complete surveys at baseline and 1-month follow-up. An embedded substudy     will also evaluate the feasibility and acceptability of collecting biospecimens (saliva) to     serve as biochemical verification of smoking status.   "
54624|NCT02570633|"     The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment     of migraine.   "
54625|NCT02570620|"     Study of the contribution of ultrasound measurements of the uterine cervix related to the     calculation of Bishop score. Evaluation of the period between cervical induction and     delivery. Study of ultrasound data to improve the care of these patients requiring induction.   "
54626|NCT02570607|"     BNP is a hormone that predicts preoperatively the occurrence of postoperative cardiovascular     complications. In practice, the problem is that the practitioner don't know the most     opportune moment for the preoperative sample or what threshold used to classify our patient     in patients at risk of cardiovascular complication or not at risk.      The purpose of this study is to determine the best time to dose the preoperative BNP with a     specific threshold being associated with it allowing the practitioner to assess more     accurately the post operative cardiovascular risk patients and possibly offer them strategies     taking different load.      The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate     preoperative operating room. Post-operative cardiovascular complications will be collected     during hospitalization of the patient and by telephone contact on the 28th day, 90th day and     6th postoperative months.      The investigator then establish the threshold BNP most informative for both sampling times     and then compare them to determine the most discriminating dosage and thus the most     appropriate time for the determination of BNP.   "
54627|NCT02570594|"     The aim of the study is to investigate the temporal organization of autobiographical memory     in patients with schizophrenia. Patients and control participants will be invited separately     to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an     automatic camera around their neck, which is called SenseCam®. Pictures obtained with     SenseCam® will be later presented to the participants during the session of test. They will     be asked to determine the chronological order of 12 pictures corresponding to 12 particular     events of the tour. Then they will be asked to watch the complete sequence of photos from the     tour and to determine the beginning and ending of the events that have occurred during the     tour. According to the investigators hypotheses, patients should have difficulty to find out     the correct chronological order of the photos and to determine the appropriate beginnings and     endings of the events   "
54628|NCT02570581|"     Elderly people often suffer from chronic pathologies and they are given polypharmacy. In case     of swallowing problems, the drugs are crushed and mixed in food, which alters the taste of     food and is a cause of anorexia and malnutrition. Gustative side-effects of crushed drugs     have nether been investigated. The MELA study is a one session hedonic test involving 16     healthy volunteers. They will score in a blind manner the taste of 10 drugs commonly     prescribed in nursing homes, crushed in jelly or apple compote. These volunteers will be 8     food professionals and 8 geriatric care professionals. Thanks to the MELA protocol, they will     have a unique opportunity to communicate and propose solutions to this neglected aspect of     malnutrition in elderly populations.   "
54629|NCT02570568|"     Our novel technique of pen-torch transillumination (PTI) uses a cheap and easily available     instrument (Penlite-LP212®, Energizer®, Missouri, USA) to visualize superficial veins     invisible to the naked eye. The investigators evaluate the efficacy of PTI in improving     venepuncture success rate (SR) for patients with poor venous access.      This prospective randomized controlled trial looks at adult patients aged 21 to 90 with     difficult venous access (history of ≥3 consecutive attempts required for successful     cannulation during the current admission) requiring non-emergent venepuncture. Patients will     undergo venepuncture over the upper-limb using one of the following: Conventional     venepuncture (control); Veinlite® (TransLite®, Texas, USA), a commercial transillumination     device; PTI. Outcome measures are: successful cannulation within 2 attempts; duration of each     successful attempt. Fisher's exact and Kruskal-Wallis tests will be performed.   "
54630|NCT02570555|"     The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of     patients with strabismus may be reduced. The goal of this work is to study the possible     amelioration of driving ability after strabismus surgery and to compare the driving     capacities of patients with strabismus to a normal population; Patients will be tested before     and after strabismus surgery using a driving simulator, binocular visual field and binocular     visual acuity.   "
54631|NCT02570542|"     The purpose of this study is to study the impact of stem cell dose on outcome after     autologous transplant.   "
54642|NCT02570399|"     This is a prospective, multicentric, phase II and feasibility study aimed to address early     and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients     with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.   "
54632|NCT02570529|"     Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. About 40%     of pancreatic cancer patients were diagnosed as locally advanced unresectable status without     distant metastasis. Concurrent chemoradiotherapy (CCRT) was a reasonable treatment modality     for locally advanced pancreatic cancer. However, several adverse events of chemoradiation     could lead unfavorable treatment results, which included unique gastrointestinal (GI)     toxicities, such as ulcer and hemorrhage in the stomach and duodenum that are included in the     radiation field. According to the study in the investigators hospital, 45% of locally     advanced pancreatic cancer patients treated with CCRT suffered from GI ulcers, and among     them, 65% of the patients experienced the significant hemorrhage events. Although these GI     toxicities, the studies for radioprotective agents were limited. Albis® is a newly developed     drug comprised of ranitidine, bismuth and sucralfate. The investigators will investigate the     radioprotective effect of Albis® for locally advanced pancreatic cancer patients treated with     CCRT.   "
54633|NCT02570516|"     This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo     carmine chromoendoscopy) in patients having Lynch Syndrome   "
54634|NCT02570503|"     This study will evaluate the use of a local injection around the knee (periarticular) during     total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The     injection is a combination of various medications which are thought to reduce pain levels.      Approximately 128 patients will participate in this study, half of the patients will receive     this injection during surgery and the other half will receive a saline (salt water)     injection. Pain scores after the surgery will be compared between the two groups.      All patients will also receive a long-acting (24 hours) morphine injection during surgery.      The hypothesis is that those participants receiving intrathecal Duramorph and local     periarticular injections will have improved pain scores and reduced narcotic use when     compared with intrathecal Duramorph alone at 48 hours postoperatively.   "
54635|NCT02570490|"     Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral     CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with     ABSSSI   "
54636|NCT02570477|"     Clostridium difficile infection (CDI) is a leading cause of hospital-associated     gastrointestinal illness, associated with significant morbidity and mortality and has a high     burden on health-care system. The incidence of CDI has increased to epidemic proportion     worldwide over the past decade. Community-acquired CDI, elderly and hospitalized patients     receiving antibiotics are the main group at risk for developing CDI.      Currently, the first-line treatment for C. difficile-associated diarrhea includes cessation     of the antibiotic implicated in the development of CDI, treatment with metronidazole or     vancomycin and recently Fidaxomicin which is yet to be available in Hong Kong. However,     disease recurrence is an increasing problem and 20% to 60% of patients experience at least     one recurrence within a few weeks of completion of antibiotic treatment. Moreover, an     increasing number of patients who require life-saving emergency colectomy experience     persistent CDI after surgery. Until recently, an effective treatment against recurrent CDI is     not available. Generally, repeated and extended courses of vancomycin are prescribed.      Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to     affected subjects has attracted great interest in recent years and is now recommended as the     most effective therapy for CDI not responding to standard therapies. Systematic reviews of     prospective trials, case series and one randomized controlled trial have shown an overall     cure rate of close to 100%. More than 50% of patients stated they would have FMT as their     preferred first treatment option if CDI were to recur.      This proposal aims to investigate the efficacy of FMT as first line therapy in patients with     severe CDI and to assess changes in the fecal microbiota after FMT using pyrosequencing     techniques.   "
55801|NCT02555228|"     A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid     simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given     at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility     score.   "
54637|NCT02570464|"     Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after     abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during     open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of     reactive oxygen species (ROS) and inflammatory cytokines which damage distant organs,     including heart, kidney, and lung.      Ischemic preconditioning, first described in cardiac surgery, is a mechanism whereby tissues     exposed to a brief period of nonlethal I/R develop resistance to subsequent ischemic insult.     Remote ischemic preconditioning (RIPC), is a phenomenon whereby brief periods of ischemia     followed by reperfusion in one organ (usually skeletal muscle) provide systemic protection     from prolonged ischemia. The mechanisms through which RIPC confer organ protection remains     unclear.      The hypothesis is that limb RIPC would reduce systemic inflammatory mediators produced by     ischemia-reperfusion and thereby protect the remote organs.      A single-center, prospective, randomized, parallel-group controlled trial is conducted on     patients undergoing elective open infrarenal AAA repair. Written informed consent is obtained     from each participant. The study protocol was reviewed and approved by the Research Ethics     Committee of Rouen, France.      Patients are divided in two groups : the sham-operated control group underwent surgery     without RIPC and the RIPC group : Two cycles of intermittent crossclamping of the common     iliac artery (right or left) with 10 minutes ischemia followed by 10 minutes reperfusion     served as the RIPC stimulus, before prolonged ischemia.      Blood samples are collected for analysis at the following time points: before surgery     (baseline), 1, 3 and 24 h after cross-clamp release (reperfusion). The systemic inflammatory     response is measured using the serum concentrations of TNF-alpha, and IL 1, 4, 6, 10.     Cardiac, renal and pulmonary functions are evaluated with usual biological markers and     clinical monitoring until 28 days after surgery.      Aortic surgery is a perfect clinical model of ischemia-reperfusion which makes it possible to     study the impact of RIPC in humans. This biological approach would help to better understand     the mechanisms underlying this technique.   "
54638|NCT02570451|"     The overall objectives of this study are to improve outcomes of surgical patients 65 years of     age or older through risk stratification based on preoperative screening of cognition /     mental function. Aim 1 is to determine the prevalence of cognitive impairment among patients     65 years of age or older presenting for elective joint replacement surgery by structured     cognitive screening versus standard practice. Aim 2 is to ascertain whether preoperative     cognitive impairment in patients 65 years of age or older undergoing elective joint     replacement surgery is an independent predictor of adverse postoperative events and/or     mortality. Aim 3 is to implement routine structured preoperative cognitive screening of     patients 65 years of age or older undergoing elective surgical procedures in a busy     preoperative clinic.   "
54639|NCT02570438|"     The hypothesis is that structured preoperative cognitive screening of seniors is feasible     without specialized staff and can help preoperatively identify persons at high risk of     complications. To demonstrate generalizability of the single center experience, and     strengthen the case for routine preoperative cognitive screening of seniors, the aims of this     proposal are to implement preoperative cognitive screening of seniors in the preoperative     clinics of a community hospital (NWH) and a 2nd tertiary care institution (MGH); and     determine whether impairment is an independent predictor of adverse perioperative events.   "
54645|NCT02570360|"     The research study compares the substance abuse treatment outcomes (e.g., craving, withdrawal     symptoms, rates of use, abstinence) of standard intensive outpatient care, with or without an     added 6-wk aerobic exercise component. In addition, certain biomarkers associated with both     exercise and substance use (e.g., endocannabinoids and cortisol) will be assessed. In a     rolling admissions format over the course of a year, approximately 36 treatment-seeking     substance users who are currently receiving Intensive Outpatient Treatment through a local     Alcohol or Other Drug Abuse agency will be randomized to either receive 6 weeks aerobic     exercise training in addition to standard care or standard care with 6 weekly laboratory     visits to complete questionnaires (18 per group).   "
54646|NCT02570347|"     Clinicians tend to overuse antibiotics in snake bite despite evidence from three previous     clinical trials that failed to show a benefit. But, none of these trials was done in India.     Further, the species of snake in two of these trials was quite different from that seen in     the Indian setting limiting generalization of these findings. Hence, home-grown evidence is     needed to persuade clinicians to use antibiotics rationally.   "
54647|NCT02570334|"     This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old     children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to     provide complementary information to the trials CHER and PREDICT on the long term development     of (1) HIV-infected children according to age at ARV initiation and (2) HIV exposed but not     infected children, all compared with the control group of children uninfected, unexposed to     HIV.   "
54648|NCT02570321|"     The primary purpose of this study is to determine if patients randomized to corneal collagen     cross-linking plus medical therapy will have a lower prevalence of positive bacterial or     fungal cultures immediately after the procedure than patients who received medical therapy     alone.      The secondary purpose of this study is to determine if patients randomized to corneal     collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who     receive medical therapy alone.   "
54649|NCT02570308|"     IMCgp100-102 is a Phase I study of the weekly intra-patient escalation dose regimen with     IMCgp100 as a single agent in patients with metastatic uveal melanoma (mUM). According to     this regimen, all patients in the trial will receive 2 weekly doses of IMCgp100 at a dose     level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose     escalation will commence at the third weekly dose at C1D15. The Phase I testing of the     intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal     plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter .   "
54650|NCT02570295|"     The purpose of this study is to determine whether the new sport concept of the Swiss Armed     Forces influences the physical and psychological fitness of the recruits.   "
54651|NCT02570282|"     This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way     crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A     sufficient number of participants will be enrolled to yield 30 (approximately 15     pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo     Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).   "
54652|NCT02570269|"     The study has to show that an intubation with the AuraGain Laryngeal mask could bring the     same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.   "
54674|NCT02569983|"     The primary aims of the SOCQER-2 study are to describe any impact on short (6 weeks), medium     term (6, 12 months) and long term (18 months, 24 months) PRO/quality of life using validated     questionnaires in patients undergoing standard or extensive surgery for suspected or     confirmed Stage III/IV ovarian cancer and to describe progression free survival (PFS) in     these patients.   "
54653|NCT02570256|"     This study investigates the potential of customized robotic and visual feedback interaction     to improve recovery of movements in stroke survivors. While therapists widely recognize that     customization is critical to recovery, little is understood about how take advantage of     statistical analysis tools to aid in the process of designing individualized training. Our     approach first creates a model of a person's own unique movement deficits, and then creates a     practice environment to correct these problems. Experiments will determine how the     deficit-field approach can improve (1) reaching accuracy, (2) range of motion, and (3)     activities of daily living. The findings will not only shed light on how to improve therapy     for stroke survivors, it will test hypotheses about fundamental processes of practice and     learning. This study will help us move closer to our long-term goal of clinically effective     treatments using interactive devices.   "
54654|NCT02570243|"     This is a prospective, multi-center, superiority study of parallel design. Patients are     enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary     angiography and the interventional cardiologist is willing to proceed with radial access.     Patients are randomized before diagnostic catheterization to receive intravenously either     100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged     usually within 4 to 6 hours after coronary angiography.      Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by     one physician who is blinded to the actual antithrombotic treatment given. Radial artery is     considered occluded if it exhibits ultrasonographically no antegrade flow signal both at     baseline and after reevaluation on a second occasion, within 30 days after the index     procedure. Initially patent arteries will not be reexamined and are thought to remain     permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL     decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding     (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined     as those extending beyond the forearm).   "
54655|NCT02570230|"     Thoracotomy is one of the most painful operation. Continuous thoracic epidural or     paravertebral analgesia are gold standard for postoperative pain. But both techniques require     skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose     ketamine during intraoperative may be helpful in postoperative pain relief.   "
54656|NCT02570217|"     Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the     following treatments as non invasive respiratory support if they develop mild to moderate     Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2)     HHHFNC providing a flow 4-6 l/min.      The aim of the study is to assess efficacy and safety of relative new form of respiratory     support (HHHFNC) versus a more common one (NCPAP).   "
54657|NCT02570204|"     This study aims to investigate the effectiveness and acceptability of the multi-level     pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.   "
76018|NCT02290821|"     This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction     of the pain associated with acute blunt trauma injuries.   "
54659|NCT02570178|"     The objectives of this study are to evaluate the usefulness of an intervention utilizing the     NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of     falling as well as the number of falls, and to evaluate the correlation between balance as     determined by the console and the value obtained in the Tinetti tests and the one foot     stationary test.   "
54660|NCT02570165|"     Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and     beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled,     double-blind, parallel group study primarily designed to assess the dose response, efficacy     and safety of five dose regimens of batefenterol administered via the dry powder inhaler     (DPI) once-daily in the morning for 42 days in subjects with COPD. The information obtained     from this study will be used to select the minimal, optimally effective and safe dose of     batefenterol and also to evaluate the pharmacokinetic profile and established pharmacodynamic     (PD) responses of batefenterol. These data will support for future studies with batefenterol     in COPD subjects.      The study will consist of a pre-screening visit, screening visit; a run-in period (2 weeks),     treatment period of 42 days and a follow-up visit 7 days post-treatment. The total duration     of the study for each subject will be approximately 9 weeks. Approximately 460 subjects will     be screened in order to randomize approximately 320 subjects, assuming that 280 subjects will     complete the study. During treatment period, subjects will be randomized to one of the     following treatments delivered via DPI once daily in the morning: Batefenterol 37.5 mcg, 75     mcg, 150 mcg, 300 mcg and 600 mcg, umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and placebo.     All subjects will receive supplemental albuterol/salbutamol to be used on an as-needed basis     (rescue medication) throughout the study.   "
54661|NCT02570152|"     The purpose of this study is to determine the incidence of dengue fever and to build capacity     for dengue vaccine trials in dengue-endemic regions of South Asia.   "
54662|NCT02570139|"     The purpose of the study is to evaluate the safety and efficacy of the investigational     product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of     incontinence associated dermatitis.   "
54663|NCT02570126|"     The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of     GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.   "
54664|NCT02570113|"     The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device     which is intended to be used to ablate the afferent and efferent sympathetic nerves serving     the kidneys. The catheter is inserted via the femoral artery, steered into the renal artery,     and then delivers, by infusion from its distal end, a neurolytic agent. This targets the     nerve bundles, which are in the adventitia - a sheath surrounding the artery. The aim is to     reduce blood pressure in cases of hypertension, including seriously elevated blood pressure     which does not respond to drug treatment. This study will evaluate the safety and performance     of the device.   "
54697|NCT02569684|"     The aim of the study is to compare the effects of prebiotics versus placebo on blood     concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.   "
55887|NCT02554110|"     This study is designed to determine if using peripheral nerve stimulation in conjunction with     pulse oximetry as an adjunct to traditional monitoring in the PACU reduces the frequency and     severity of sedation related apnea and hypoxic events.   "
54665|NCT02570100|"     From a cellular perspective, breast cancers appear to develop hierarchically from a small     contingent of cancer stem cells (CSCs). The presence of CSCs in tumor tissue is associated     with an increased risk of recurrence and metastasis, as well as a worse prognosis. Thus,     these CSCs exhibit resistance to conventional anti-tumor treatments such as radiotherapy and     chemotherapy. Moreover, these treatments would favor the emergence of these CSCs and the     reprogramming of non-CSCs in CSCs. It has been demonstrated in neoadjuvant that the     proportion of CSCs before any treatment is correlated with chemoresistance and that a     resurgence of CSCs after chemotherapy is correlated with a poor prognosis. However, the     mechanisms involved in the emergence of CSCs by reprogramming of non-CSCs are not yet known.      The Oscar Lambret Center proposes a monocentric prospective interventional study based on the     cellular and molecular analysis of the tumor, serum and circulating cells, before, during and     at the end of the treatment for each patient receiving a neoadjuvant chemotherapy for breast     cancer. The identification of the mechanisms contributing to the enrichment of CSCs resistant     to chemotherapy could lead to therapeutic solutions.   "
54666|NCT02570087|"     The investigators studied the effect of CTO-PCI on left ventricular function and clinical     parameters in patients with HFrEF.   "
54667|NCT02570074|"     Oral dosage regimens for fosfomycin tromethamine (Monurol™) are not established for the     treatment of cUTI. The most common and recommended adult dosage regimen in the literature is     a single-dose sachet containing the equivalent of 3 grams of fosfomycin administered every     other day (QOD) for a total of three doses.      There are a myriad of different oral fosfomycin dosing regimens currently being used in     clinical practice, including up to 3 grams orally twice daily for 7-21 days, but these     regimens are not based on solid pharmacokinetic, pharmacodynamic or safety rationale. Initial     pharmacokinetic studies performed with oral fosfomycin tromethamine primarily examined single     dose regimens and did not use modern day bioanalytical or pharmacokinetic techniques. As the     use of fosfomycin becomes more pervasive in concordance with the increase in multidrug     resistant pathogens, further pharmacokinetic and safety data are needed for more intensive     dosing regimens to support its continued use.      The rationale of this study is that oral fosfomycin tromethamine requires a modern     pharmacokinetic-pharmacodynamic study to identify alternative oral dosage regimens that are     appropriate and safe. This study will provide safety/tolerability and clinical pharmacology     information regarding two oral dosing regimens that may have application to treat various     types of infections involving resistant pathogens or when other oral antibacterial options     are not available.   "
54668|NCT02570061|"     This study examined the use of the telephone for the purpose of informing expectant mothers     about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination.     Expectant mothers who were contacted for participation in a vaccination trial (the Calmette     study, NCT01694108) were randomized to receive information by telephone or at a face-to-face     consultation. The primary outcome was a communication score, consisting of comprehension of     information about the study and satisfaction with the information process. The outcome was     measured using a questionnaire two weeks after the information was provided and two and a     half months after birth.   "
54995|NCT02565797|"     Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its     effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative     setting. The primary objective of the study is to compare the prevention-effectiveness     (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care     pressure-relieving device(s) (control group) peri-operatively to discharge.   "
54669|NCT02570048|"     This is a novel experimental device 'MuteButton' can affect the awareness of tinnitus. Sound     that arrives at the ears naturally will be presented in the form of touch patterns on the     tongue. By learning to associate the sounds in the ears with the sound patterns on the     tongue, investigators aim to demonstrate that the brain will learn to discriminate the real     sounds from legitimate external sounds from the imaginary tinnitus sounds that are created     inside the brain. Tinnitus is an audiological condition most commonly described as 'ringing     in the ears' that affects an estimated 40 million people globally (American Tinnitus     Association; Royal National Institute for Deaf). More accurately, tinnitus is the perception     of illusory sound that has no legitimate external source and normally arises from a small     number of underlying neuropathologies. There are broadly two categories of tinnitus Somatic     Tinnitus and Hearing Loss Related Tinnitus.      MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The     study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The     objective of the study will be to determine the impact of acoustic and tactile multi-modal     neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and     subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking     (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale     (VAS).   "
54670|NCT02570035|"     This purpose of this study is to investigate the effects of mirabegron on the cardiovascular     system in patients with overactive bladder with current or a history of cardiovascular     disease.   "
54671|NCT02570022|"     This is a randomized, single blinded, standard of care controlled clinical trial. All adult     patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares     pain control and opioid consumption in patients undergoing shoulder arthroplasty between     patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene     nerve block.   "
54672|NCT02570009|"     Obesity risk is shared within married couples yet most existing weight loss programs focus on     individuals and not the marital dyad. This project will test the effects of a couples weight     loss program that teaches spouses how to provide each other with autonomy support and create     an interpersonal environment that promotes sustained behavior change.   "
54673|NCT02569996|"     This study will evaluate the efficacy, safety, and tolerability of long-term maintenance     therapy with rituximab in participants with advanced follicular lymphoma who have had a     positive response to first-line treatment with a rituximab-containing regimen. The     anticipated time on study treatment is 2 years, and the target sample size is 124     individuals.   "
55404|NCT02560558|"     The purpose of this study is to transition patients who have been stable on Belatacept for     one year after kidney transplant from standard 4-week to an investigational 8-week belatacept     dosing schedule. The investigators hypothesize that renal function and acute rejection rates     will be non-inferior with 8-week belatacept dosing.   "
54675|NCT02569970|"     Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that     primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP     incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood,     it appears that the majority of such death occurs in the immediate aftermath of a general     tonic-clonic seizure.      There is currently no validated preventive treatment for SUDEP. Some evidence suggest that     modulation of the serotoninergic tone, and more specifically selective serotonin recapture     inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents     seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models     of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the     control of breathing, especially during sleep and in response to repeated hypoxia.      In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of     seizures are associated with decrease in SpO2 <90%, an abnormality suspected to represent a     risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs     displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs.      The investigators project aimed at testing whether fluoxetine can reduce the risk of     ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled trial     in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of their     focal drug-resistant epilepsy.   "
54676|NCT02569957|"     This randomized phase II trial studies the effects of acetylcysteine and topotecan     hydrochloride on the tumor microenvironment, or cells that make up a tumor, compared to     topotecan hydrochloride alone in patients with ovarian, fallopian tube, or primary peritoneal     cancer that has not responded to treatment (persistent) or has returned after a period of     improvement (recurrent) and is high grade (likely to grow and spread quickly). Research has     shown that cancer cells may be able to convert nearby normal cells into cancer cells.     Acetylcysteine may stop this from happening. Topotecan hydrochloride is a chemotherapy drug     used to treat ovarian cancer, and may help acetylcysteine work better. This trial studies the     effect of acetylcysteine and topotecan hydrochloride on the tumor microenvironment to see if     they can help make it more difficult for tumor cells to grow.   "
54677|NCT02569944|"     Randomize trial by including patients up to 12 months old in whom a urine sample by a     non-sterile method was requested under physician criteria. Intention-to-treat analysis was     made.      Urine dipstick was considered as altered if it was positive in leukoesterase test (≥2+) or     nitrite test. In patients with an altered urine dipstick, a sterile sample was obtained for     culture. If there was an initial altered urine dipstick with a subsequent negative urine     culture it was considered as contaminated urine.   "
54678|NCT02569931|"     The principal objective of the study is to find out which everyday activities make the     kneecap unstable in people with patellofemoral instability.      Analysing how a patient with an unstable kneecap walks will help us to determine if surgery     is successful in these patients by seeing if better scores on patient questionnaires are     found in patients following surgery and whether these patients also have a better pattern of     walking.      The investigators aim to use cameras and pressure pads to see how patients walk before and     after surgery and see how this compares to patient scores on the questionnaires.      If the investigators find that patients walk better after surgery they can justify that     surgery is worthwhile for the patient and cost effective for the NHS.   "
77673|NCT02269176|"     Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the     treatment of the mild to moderate primary hypertension patients in China   "
54679|NCT02569918|"     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously     difficult to treat. Amputation usually follows traumatic injuries or surgery following     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is     required for the survival of the patient. The loss of a limb or other body parts is usually     followed by the sensation that the lost body part is still present and can be felt. These     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure     on the residual limb) and psychological factors (e.g. emotional stress). It is well known     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,     psychological and other, are ineffective.      Today it is believed that phantom limb pain may be related to changes in the cortex of the     brain. There is evidence that these changes may be modulated - or even reversed - by     providing sensory input to the stump or amputation zone. For example, cortical reorganization     and alleviation of phantom limb pain has been observed in amputees following intense use of a     hand prosthesis. However, there is no consistent knowledge on which type of peripheral     sensory feedback may be effective in affecting the cortical plasticity or on how to best     apply the sensory feedback.      The aim of the proposed research is to create natural, meaningful sensations through     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.   "
54680|NCT02569905|"     Shivering is an early postoperative complication during the postoperative recovery period,     and there is no clear consensus about the best way for its prevention. The aim of the study     was to compare the efficacy and accompanying side effects of prophylactic flurbiprofen with     that of parecoxib or placebo for reducing postoperative shivering.   "
54681|NCT02569892|"     This is a randomized controlled study of non-damaging photothermal macular grid laser versus     sham laser therapy in patients with dry age-related macular degeneration (AMD) and large     high-risk drusen. The goal of the study is to determine if this treatment will reduce macular     drusen volume and also whether this might improve visual acuity or reduce the risk of     conversion to advanced age-related macular degeneration defined as development of choroidal     neovascularization or geographic atrophy.   "
54682|NCT02569879|"     This study is being conducted to assess impact of maternal immunisation against pertussis in     infants ≤12 months of age before and after introduction of pertussis maternal immunisation in     Bogota, Colombia from January 2005-December 2014.   "
54683|NCT02569866|"     This study was designed to determine the role of antibiotics reduction mammaplasty influence     surgical site infections rates.   "
54684|NCT02569853|"     Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.   "
54685|NCT02569840|"     This study of the tolerance and acceptability of an amino acid based feed will assess     gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste,     smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid     based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated     conditions, over 4 weeks.   "
56382|NCT02547636|"     This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.   "
54686|NCT02569827|"     Dengue fever is an acute febrile illness transmitted by mosquitoes, which affects half the     world's population. There are 96 million symptomatic infections, 500,0000 hospitalisations     and 25,000 deaths per year attributed to the disease. The economic burden is $12 billion. In     Singapore, as elsewhere, the incidence of the disease continues to increase despite     aggressive control measures. At present there are no approved medicines for treating dengue     fever. Only supportive fluid replacement therapy is used to treat vascular leakage in     patients with severe illness. Therefore there is an urgent need to find alternative     treatments. Experiments in the laboratory have shown that Celgosivir and modipafant inhibit     dengue virus and improve mouse survival. Both drugs have previously been used in humans with     good safety records, so investigators are taking this one step further to find out how well     it works in dengue patients. Investigators plan to enroll dengue patients within 48 hours of     fever onset and assign them to one of four treatment groups over five days. Together with the     support from the industry partner, 60°Pharmaceuticals PLC, the investigators will determine     the safety and effectiveness of these drugs on acute dengue patients and pave the way forward     for dengue antiviral medicines to reach patients.   "
54687|NCT02569814|"     A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics     and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus     Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in     Healthy Male Subjects.   "
54688|NCT02569801|"     The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of     GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic     estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-)     breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the     Sponsor and the enrollment in this study has been discontinued. Participants currently     enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810     as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity,     withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the     Sponsor.   "
54689|NCT02569788|"     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation     using carbon ion radiotherapy (CIRT) in the treatment of locally recurrent nasopharyngeal     cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be     treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD)     in terms of acute and subactue toxicity observed during and within 4 months after the     completion of CIRT. Once the MTD for locally recurrent NPC is determined, the MTD will be     used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II     part of the trial.   "
54690|NCT02569775|"     The aim of this study is to assess the safety and effectiveness of autologous bone marrow     mononuclear stem cells in patients with cerebral palsy.   "
54691|NCT02569762|"     The Objectives of this study is to determine the effect(s) of daily non-caloric artificial     sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and     also to determine the changes in glucose metabolism.   "
54692|NCT02569749|"     To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and     central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator     (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left     ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.   "
71336|NCT02352012|"     The purpose of this study is to determine whether injecting autologous blood or putting     bronchial plug through bronchoscope is effective in the treatment of refractory pneumothorax.   "
54693|NCT02569736|"     Naïve CD4+ helper T (Th) cells, upon encountering their cognate antigens presented on     professional antigen-presenting cells, differentiate into different effector cells:        -  Th1 cells produce Interferon-γ and regulate antigen presentation and immunity against          intracellular pathogens;        -  Th2 cells produce IL-4 (Interleukin-4), IL-5 and IL-13, and mediate humoral responses          and immunity against parasites;        -  Th17 cells produce IL-17, IL-17F and IL-22 and regulate inflammatory responses by tissue          cells.      An additional TH subset called follicular helper T (Tfh) cells has recently been identified     in germinal centers and also in whole blood (circulating Tfh cells). These cells regulate     B-cell maturation and immunoglobulin production during normal immune responses. They produce     factors essential for B cell selection and maturation into memory B-cells or long-lived     antibody-secreting plasma cells. Furthermore, they also seem to favor pathogenic autoantibody     production in systemic autoimmunity, and therefore could potentially represent a novel     therapeutic target in autoimmune diseases. Indeed, rheumatoid arthritis synovium is     characterized by the presence of ectopic lymphoid structures, resembling germinal centers.     Potentially, Tfh cells from these nonlymphoid tissues could promote B-cell maturation and     synthesis of pathogenic autoantibody production, thus potentiating tissue injury.     Interestingly, production of IL-21 by Tfh cells is implicated in B cell activation, and the     same cytokine have been associated with rheumatoid arthritis (RA) pathogenesis.      IL-6 blocking therapy significantly reduces signs and symptoms as well as radiological     progression in RA. However, so far, it has not been determined which of the pleiotropic IL-6     effects impact the observed clinical response. Recently, Samson et al have demonstrated that     Tocilizumab (TCZ) corrects the imbalance between Th17 cells and Treg cells in patients with     RA. More interestingly, the group of Hans-Peter Tony has reported the impact of TCZ on B cell     compartment. They showed a significant reduction in the frequency of peripheral pre-switch     and post-switch memory B cells but also a reduction of serum immunoglobulin levels, that     could be the reflect of TCZ on Tfh cells development, circulation and/or function.      Most of the work studying the role of IL-6 on Tfh cells development has been performed in     mice. They showed that optimal Tfh cells formation requires IL-21 and IL-6, and that     cytokines alone are insufficient to drive Tfh cells differentiation.      To better understand the impact of IL-6 on human Tfh cells, the investigators would like to     conduct a prospective study in patients with active RA and investigated the effects of     blocking IL-6 with TCZ on circulating Tfh cells levels and Tfh cells subsets over a 12-week     study period. Furthermore, the impact of TCZ treatment on Tfh cells generation will be     explored in vitro.   "
54694|NCT02569723|"     This pilot clinical trial studies how well carbon C 14 oxaliplatin microdosing assay works in     predicting exposure and sensitivity to oxaliplatin-based chemotherapy in patients with     colorectal cancer that has spread to other places in the body and usually cannot be cured or     controlled with treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Carbon C 14 is a radioactive form of carbon,     exists in nature and in the body at a low level. Microdose carbon C 14 oxaliplatin diagnostic     assay may help doctors understand how well patients respond to treatment and develop     individualize oxaliplatin dosing in patients with colorectal cancer.   "
54695|NCT02569710|"     This randomized, open-label study will assess the safety, pharmacokinetics and efficacy of     the orally administered combination of AL-335, ACH-3102, and simeprevir in treatment-naïve     subjects with chronic hepatitis C (CHC) infection.   "
54696|NCT02569697|"     The purpose of this study is to develop markers for use of placebo vaginal products and     measure markers of mucosal semen exposure among healthy women. The study will also monitor     safety of placebo product use.   "
54698|NCT02569671|"     The aim of this randomized, controlled, multi-center study is to assess the clinical and     radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate     implantation following extraction of a tooth in the pre-molar and anterior region of the     maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites     (control).   "
54699|NCT02569658|"     To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine     whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of     transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.   "
54700|NCT02569645|"     This study will evaluate whether the addition of Rosuvastatin to standard chemoradiation     therapy for the treatment of locally advanced rectal cancer may improve the pathological     response rate and survival compared to standard chemoradiation therapy alone.   "
54701|NCT02569632|"     This study will investigate the breadth of protection against meningococcal disease in humans     immunized with a newly FDA approved meningococcal B vaccine, trade name Trumenba®     manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate     underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated     bactericidal activity.   "
54702|NCT02569619|"     The purpose of this study is to determine if a manualised intervention to promote physical     activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of     everyday physical activity.   "
54703|NCT02569606|"     Comparison of the consumption of blood and coagulation products (packed red blood cells,     fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates,     coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics)     before and after the introduction of a designated trauma related transfusion and coagulation     algorithm.The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed.     Two level-1 trauma centers in Switzerland (Hospital Lucerne, University Hospital Zurich) are     included in the study. Predicted probability of a massive transfusion by the trauma     associated acute hemorrhage score (TASH)is correlated with the actual rate.   "
54704|NCT02569593|"     Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to     participate in a cross-over study using commercial available iron supplements. The aim of     this study is to evaluate the absorption rate of different oral iron supplements in     volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).   "
54705|NCT02569580|"     The purpose of this study is to determine effectiveness of an Anti-lice treatment using the     medical device No More which is designed to kill lice and lice eggs on the head.   "
54706|NCT02569567|"     The aim of this prospective study was to evaluate the applicability and diagnostic     performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE)     for the staging of liver fibrosis using pathologic results as the reference standard.   "
54707|NCT02569554|"     The current study will be conducted in healthy adult subjects to evaluate the effect of     proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the     bioavailability of the oral solution relative to the tablet formulation of PF-06463922.   "
54708|NCT02569541|"     To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic     antibiotic for the treatment of bone or joint infections.   "
71725|NCT02346929|"     The purpose of this study is to determine the efficacy of ultrasound guided hematoma block     versus traditional blind hematoma block for analgesia in distal radius fracture reduction.   "
54709|NCT02569528|"     The goal of this study is to learn about the patient and provider perceptions, priorities,     preferences, and willingness to use/prescribe anticoagulation as a stroke prevention therapy     in patients with atrial fibrillation. Qualitative interviews will be performed with atrial     fibrillation patients and providers caring for atrial fibrillation patients. The     investigators want to understand the factors that influence decision-making about     anticoagulation medications, and to gain insight into patients' and providers' knowledge of     the risk of stroke and bleeding associated with oral anticoagulation. This feedback will help     provide better education to providers caring for patients with atrial fibrillation and better     care to patients with atrial fibrillation by developing tools to optimize the appropriate use     of oral anticoagulation for patients with atrial fibrillation.   "
54710|NCT02569515|"     This study will evaluate the tolerability, and effect on quality of life, in patients     receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic     renal anemia. The anticipated time on study treatment is 10 months, and the target sample     size is 60 individuals.   "
54711|NCT02569502|"     This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with     advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently     available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and     the target sample size is 9 individuals.   "
54712|NCT02569489|"     This is a phase I multi-center dose escalation study of the histone deacetylase inhibitor     (HDACi) HBI-8000 when given in combination with paclitaxel and trastuzumab in women with     advanced or metastatic HER2+ breast cancer.   "
54713|NCT02569476|"     This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with     obinutuzumab in subjects with B-cell lymphoid malignancies.   "
54714|NCT02569463|"     The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human     Interleukin-2 （rhIL-2） for MAS.   "
54715|NCT02569450|"     This two arms parallel cluster-randomized trial will evaluate the impact of monitoring     surgical outcomes using Shewhart control chart (intervention) on the occurence of major     adverse events, among a large sample of French surgical departments. Trends in surgical     outcomes before and after the intervention will be compared between arms.   "
54716|NCT02569437|"     The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease with     polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be     eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms and     avoid surgery. The treatment combines an antibiotic (doxycycline) with oral steroids. Oral     steroids are the mainstay of medical management for patients with CRSwNP. However, recent     studies have shown that doxycycline helps improve symptoms as well by reducing inflammation     and killing common bacteria that can cause symptoms. This study is the first to evaluate this     combination regimen.   "
54717|NCT02569424|"     There is no recommendation for the management of the positive end-expiratory pressure (PEEP)     during setting of a central venous catheter (CVC) in a ventilated patient. Several     non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis     for different pressure levels by evaluating a single vessel every time or by not displaying     the right or left side in the evaluation. Another study showed that there could be     unpredictable size differences between the 2 subclavian veins.      In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous     return and thus possibly a superior vena cava dilation, located outside the pleura, depending     on their capacitance. Different pressure levels showed an increase of AST with the increase     of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.      The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and     the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area     of the jugular and subclavian veins.   "
54718|NCT02569411|"     The objective of this study is to examine the impact of incentivizing authors of RCTs that     are eligible for a systematic review and meta-analysis, versus usual contact strategies to     obtain original IPD   "
54719|NCT02569398|"     The purpose of this study is to evaluate whether treatment with JNJ-54861911 slows cognitive     decline compared with placebo treatment, as measured by a composite cognitive measure, the     Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are     asymptomatic at risk for developing Alzheimer's dementia.   "
54720|NCT02569385|"     The aim of the present study is to determine the cardiovascular function/ cardio respiratory     interaction on spontaneous breathing trials in patients with prolonged weaning.   "
54721|NCT02569372|"     This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the     Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B     Human Immunoglobulin) in Chronic Hepatitis B Patients.   "
54722|NCT02569359|"     Recurrent hemarthrosis results in synovitis and destructive arthropathy in hemophilic     patients. Prophylactic replacement, physical therapy, cyclooxygenase-2 (COX-2) inhibitors,     corticosteroids, and radionucleotide synovectomy are some of the typical modalities used in     the managements hemophilic synovitis and arthropathy. In clinical practice, the choice of     non-steroidal anti-inflammatory drugs (NSAIDs) also needs to take into consideration the risk     for cardiovascular events and should be used at the lowest effective dose and for the     shortest duration.This study will investigate the safety and efficacy of Shea nut oil for the     treatment of hemophilic arthropathy.   "
54723|NCT02569346|"     Dolutegravir is an HIV-1 integrase inhibitor which is marketed as a single tablet (Tivicay®)     and in a fixed dose combination tablet with abacavir and lamivudine (Triumeq®, referred to as     TRI). For patients with swallowing difficulties, administration of whole tablets can be     problematic and tablets are cut or crushed to ease administration.      Currently there is no information about crushing TRI tablets. Therefore this study will be     conducted to investigate whether crushed and suspended TRI and crushed and suspended TRI with     drip feed are bioequivalent to taking TRI as a whole.   "
54996|NCT02565784|"     The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and     Restylane Perlane Lidocaine after the first and second treatment when used for facial     augmentation in Asian population.   "
72149|NCT02341365|"     Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin     D, ovarian reserve and ovarian response to controlled stimulation in egg donors.   "
54724|NCT02569333|"     Hospitalized patients with ulcerative colitis (UC) are at increased risk for a variety of     complications such as infections, venous thrombosis, and surgery. The literature has revealed     significant variation in the quality of care to hospitalized UC patients. As a result,     guidelines for the management of these patients have been developed. However, the update of     guidelines are variable. Admission to hospital can also have significant impact on quality of     life due to interruptions in life commitments and lost sense of control of disease.     Maintaining a sense of self-control of disease and active participation in care has been     shown to be valuable among individuals with chronic diseases. The investigators propose the     development of a multi-site, patient centred initiative aimed at improving clinical and     patient-centered outcomes through an educational iPad based tool for patients admitted to     hospital with ulcerative colitis.   "
54725|NCT02569320|"     This pilot phase I trial studies the side effects and best dose of histone deacetylase (HDAC)     inhibitor AR-42 (AR-42) when given together with pomalidomide in treating patients with     multiple myeloma that has returned after a period of improvement. HDAC inhibitor AR-42 may     work to stop cancer growth by blocking an enzyme needed for cell growth. Pomalidomide is a     drug used in chemotherapy that works to stop the growth of cancer cells by causing them to     die. Giving HDAC inhibitor AR-42 together with pomalidomide may cause patients to respond     better to treatment.   "
54726|NCT02569307|"     This is a randomized double-blind placebo controlled trial which aims to evaluate the     efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS.     Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to     Treatment as Usual in an operationalized ARMS population in Pakistan:   "
54727|NCT02569294|"     This is a clinical non-randomized prospective study. This study had two objectives. The fist     one was to determine the interest of breast cancer patients in participating in one of three     group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the     reasons for choosing a particular group or decline the offer. The second objective was to     evaluate and compare the benefits of these three interventions on emotional distress, QoL,     sleep quality and mental adjustment to cancer, at three times after the end of the     interventions (just after the end, at a 3-month and at a 9-month follow-up).   "
54825|NCT02568007|"     The purpose of this study is to examine the effect of standard dosing of cyproheptadine for     both cycled and continuous administration, as compared to no medication, on appetite     stimulation and growth in the pediatric gastroenterology feeding team patient population. The     secondary aim is to evaluate the effect, if any, of the suspected tachyphylaxis that is     commonly associated with cyproheptadine use. The third aim will be to examine the type and     duration of side effects of cyproheptadine in this population. The ultimate goal will be to     create a standardized protocol for cyproheptadine therapy in children with feeding disorders     and suboptimal growth.   "
54728|NCT02569281|"     Scientific evidence of conservative management of subacromial pain syndrome is conflicting.     There is evidence that eccentric exercise programs are effective at medium term for this pain     condition. The inclusion of other therapeutic modalities is still controversial. A recent     study suggests that the inclusion of US-guided percutaneous electrolysis combined with     eccentric exercises can be effective at short-term for this condition. The objective of this     randomized clinical trial is to determine the effectiveness at short- and long-term of the     inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise protocol     for the management of patients with subacromial pain syndrome for pain, function, disability     and pressure pain sensitivity.   "
54729|NCT02569268|"     Arteriosclerotic vascular-related diseases have become a serious threat to human health. The     prevention and reversal of vascular events has become an important direction of medicine.     Early vascular disease detection system includes pulse wave velocity (PWV), carotid     intima-media thickness (IMT) and coronary flow velocity reserve (CFVR), flow-mediated     vasodilation (FMD), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), insulin     resistance index (HOMA-IR), hypersensitivity C- reactive protein (hs-CRP), plasma     homocysteine (Hcy), B-type natriuretic peptide (BNP), uric acid (UA), and so on. However,     there is no international and domestic comprehensive study on simple and practical evaluation     system by jointing application of these evaluation indexes to detect vascular disease.     Combined evaluation function can simultaneously detect and evaluate vascular abnormalities,     make up a single indicator shortcoming in clinical applications from multiple levels of     vascular structure and function. However, all indicators testing not only cause time     consuming, but also increase the burden on patients, resulting unnecessary waste of medical     resources. Thus, the present study was to select appropriate indicators and effective joint,     and establish the rating system, using the vascular system to predict the incidence of     terminal events, and compare this system with the previous scoring system such as FRS     (Framingham Risk Score) pros and cons.   "
54730|NCT02569255|"     Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary     vein isolation (PVI) is still controversial. Experience is reported from consecutive patients     ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or     apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All     complications possible being related to the use of NOAC are registered.   "
54731|NCT02569242|"     The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable     advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.   "
54732|NCT02569229|"     The aim is to describe the association of glucose tolerance measured with three different     tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT     and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung     function and anthropometric parameters in patients with cystic fibrosis.   "
54733|NCT02569216|"     An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart     pacemaker delivers a weak electrical current to the human uterus during active preterm labor     to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a     preterm birth.   "
54734|NCT02569203|"     To determine whether high-protein (24% of total calorie from protein) enteral nutrition of     immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan     stimulates immune functions compared with standard enteral nutrition (control: 20% of total     calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition     of immune modulating nutrients without β-glucan in critically ill patients.   "
54735|NCT02569190|"     Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in     hemiplegia patients.   "
55106|NCT02564328|"     Stroke is a frequently occurring and common diseases in nervous system,and most of the     survivors will remain disorders of motor,sensory and cognition function.Stem cell     transplantation provides a promising approach for rehabilitation. The main objective of this     study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow     mesenchymal stem cells in patients with chronic stroke.   "
54736|NCT02569177|"     Myocardial infarction and subsequent myocardial injury after cardiac surgery occurs in 7-15%     of patients undergoing cardiac surgery and is associated with an increased length of stay,     and reduced short- and long-term survival. Cardiac troponin is considered to be a cornerstone     in the diagnosis of a myocardial infarction. Heart-type Fatty Acid-Binding Protein (H-FABP)     is a new sensitive biomarker for myocardial injury. The effectiveness of using the     combination of H-FABP with Troponin to diagnose myocardial injury within 6 hours after the     onset of ischemia is well reported. Previous studies in non-surgical patients have associated     increased H-FABP with an increased risk of subsequent death and major cardiac events. The     prognostic value in cardiac surgery patients has not been studied extensively.      The objective is to estimate the association between biomarkers of myocardial injury and     myocardial infarction in patients undergoing cardiac surgery. Myocardial infarction will be     established with both a new and very early marker of myocardial injury (Heart-type Fatty Acid     Binding Proteins) as well as to a known early marker of such injury (Cardiac troponin).   "
54737|NCT02569164|"     PCO patients will be assessed clinically,urine & blood samples will be tested. Systolic &     diastolic blood pressure, serum glucose & insulin levels, lipid profile, C-reactive protein,     complete hormonal profile, and Urinary albumin excretion will be measured.   "
54807|NCT02568241|"     This study aimed to evaluate the efficacy of interferon α after prophylactic donor lymphocyte     infusion (DLI) among high-risk acute leukemia patients undergone unmanipulated blood and     marrow transplantation. Hematopoietic stem cell transplantation (HSCT) is an effective     treatment option for high-risk acute leukemia (AL). However, post-transplant relapse can     occur in some patients, and the prognosis of these patients is usually very poor.Prophylactic     DLI can decrease the risk of relapse of high-risk AL patients. Interferon α-2b exerts a     relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or     natural killer cell functions.Consequently, interferon α-2b may have potential value for     high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b     after prophylactic DLI following hematopoietic stem cell transplantation in patients with     high-risk AL can further reduce relapse rate and improve leukemia-free survival.   "
54738|NCT02569151|"     Participants were examined using the methods reported previous. All chemical laboratory data     were obtained at each clinic visit in the morning in a non-fasting state. A single specimen     at each visit was used to assess urinary albumin levels based on the 2009 guidelines of the     ADA. CBP was measured once in each clinic visit. HBP was measured every day in the morning     within 10 minutes after awakening in the sitting position, but HBP value assessed for this     study used the value measured once in the same morning at each clinic visit.      Clinic hypertension (CH) and morning hypertension (MH) were defined as systolic BP (SBP) 130     mmHg and/or diastolic BP (DBP) 85 mmHg; clinic normotension (CN) and morning normotension     (MN) were defined as SBP <130 mmHg and DBP <85 mmHg, respectively. The reason underlying that     same threshold was used for both clinic and morning values was based on criteria of the 1999     WHO-International Society of Hypertension guidelines, because this study started in 1999.     Based on HBP, subjects were divided into MH and MN patients, and anti-hypertensive drug use     was determined in each group. In addition, based on CBP, subjects were divided into CH and CN     patients. These patients were followed using the same methods used for MH and MN patients.      Outcome considered only the first event in each subject. Primary end-point was death from any     cause. Secondary end-points were new, worsened, or improved microvascular and macrovascular     events.      Risk factors related to each outcome were determined, and therapy which was added to baseline     used for each disease in patients with MH was recorded at base- and end-points.      All results are presented as means ± SD. Mean values were compared using the paired or     unpaired student t test. To compare the prevalence of events or medical treatment in patients     with and without HT on basis of HBP or CBP, Fisher's exact test with two-tailed P values was     used, and then hazard ratio and 95% confidence intervals were calculated.      Differences in outcomes between patients with HT and NT on basis of HBP or CBP at base- and     end-points in the home or in the clinic, respectively, were assessed using Kaplan-Meier     survival curves and then compared by hazard rate using the log-rank test.      Risk factors determined to be statistically related to outcomes were assessed by Cox     proportional hazard analysis.   "
54739|NCT02569138|"     The purpose of this study is to investigate the long term balance-enhancing effects of     insoles that are hard and thin for older adults. Thirty older female adults between the ages     of 65-84 years will be recruited for this study. Twenty participants (20) will wear the     experimental insole and ten (10) participants will work their usual insole, during a 12 week     period. Balance and foot sensitivity testing will take place at 0, 6 and 12 weeks. These     tests will involve measurement of body motion and foot pressure in order to evaluate balance     control. Additionally, each participant will be asked to return a bi-weekly postcard that     will report on footwear wearing patterns and any falls (or fall-related) incidents that have     occurred during the 12 weeks.   "
54740|NCT02569125|"     This is an open-label, multicenter, single-arm, phase II clinical trial of Everolimus     (RAD001) in patients with segmental overgrowth syndrome.   "
54741|NCT02569112|"     The purpose of this study is to evaluate the effect on the subject outcome using the     combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar     radiofrequency device with varipulse technology for the enhanced non-surgical treatment of     skin laxity in the flank area.   "
54742|NCT02569099|"     The burden of stroke has continued to increase in Zimbabwe in the last 3 decades. resulting     in increased burden of care to family caregivers. Caregivers who had cared for survivors for     periods exceeding 3 months indicated desire to be taught about basic care before they were     discharged from hospital and a curriculum of training based on a targeted needs analysis was     developed. One arm of the study will receive caregivers training as the intervention and the     other arm will be the control. The outcome of both the caregivers and survivors will be     compared based on selected tools. Data will be collected at baseline (at most 2 weeks after     suffering a stroke) the participants will be followed up at 3 and 12 months post stroke.   "
54743|NCT02569086|"     Antibiotic dosing in severe septic patients poses a challenge for clinicians due to the     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.      The investigators aim is to determined the pharmacokinetic profile of piperacillin 4g every 8     hour in 20 patients treated empirically for severe sepsis. A PK population model will be     established with the dual purpose to assess current standard treatment and to simulate     alternative dosing regimens and modes of administration. Time above the minimal inhibitory     concentration (T>MIC) predicted for each patient will be evaluated against MIC for pathogens     detected. Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated are 100% f T>MIC and 50%     fT>4xMIC.      Only patients who are prescribed piperacillin empirically by the treating physician are     enrolled in the study. The investigators have no influence on the choice of treatment     prescribed to the patient.   "
54744|NCT02569073|"     In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest     Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were     not adversely affected by this regiment. In fact, some cholesterol measures trended in a     favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol     twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to see     if the same goals can be achieved. More so, the study will be extended to 12 weeks to gain a     more longitudinal picture of therapy with Dronabinol. It is hypothesized that reducing the     dose and extending the duration will continue to show an improvement in symptoms as well as     no adverse metabolic outcomes.   "
54745|NCT02569060|"     The Feeding America Intervention Trial for Health—Diabetes Mellitus (FAITH-DM) is a     randomized, controlled study of the implementation of a diabetes intervention in food pantry     settings.   "
56209|NCT02549898|"     The investigators aim to investigate inflammation of cranial and meningeal arteries during     pharmacologically induced migraine attacks, using ultrasmall superparamagnetic iron oxide     (USPIO) nanoparticles and black blood imaging (BBI) MRI.   "
54746|NCT02569047|"     The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is     to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART)     restorations compared to the Hall Technique (HT) placed in a school setting. The     investigators will recruit 120 schoolchildren (6-8 years) with at least one occlusal-proximal     carious lesion in primary molar. They will be randomized and treated following best-practice     protocols to either receive an ART restoration using the high-viscosity glass ionomer cement     (EQUIA Forte, capsules, GC Corp.) or a preformed metal crown placed using the HT (3M ESPE)     cemented with glass ionomer luting cement (Fuji I Capsules, GC Corp.). Baseline measures and     outcome data (at reviews over a three year period) will be assessed through participant     report, clinical examination and parent report/ questionnaires.   "
54826|NCT02567994|"     After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in     a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to     ongoing stable doses of glimepiride in combination with metformin for 24 weeks.   "
55975|NCT02552940|"     This observational trial will evaluate the effectiveness, the consistency of evaluation     scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in     participants with RA in daily clinical practice.   "
54747|NCT02569034|"     Anhedonia, decreased motivation for and sensitivity to rewarding experiences, is present in     at least 1/3 of community dwelling older adults and is a feature of various psychiatric and     neurological disorders, including late-life depression and Parkinson's disease. Anhedonia is     associated with cognitive deficits, as well as poor clinical outcomes and increased     mortality. Recent research suggests that anhedonia comprises motivational (reward wanting)     and consummatory (reward liking) aspects. However, previous research on anhedonia has     failed to dissociate these components, which may explain the contradictory findings in the     literature. Recently, the Effort-Expenditure for Rewards Task (EEfRT) was developed in an     effort to dissociate reward components in anhedonia. The EEfRT is an effort-based     decision-making task that measures reward wanting, in contrast to commonly used anhedonia     questionnaires, which focus on reward liking. This novel task may provide a useful measure     of components of anhedonia in older adults and in different patient populations. Thus far no     data is available on this task in elderly individuals, and the cognitive and neural     correlates of components of the task have not been investigated. Given the paucity of     research on the neurobiology of anhedonia, cognitive neuroscience studies using this task     could fill a gap in the literature. The investigators are developing a line of cognitive     neuroscience studies examining anhedonia in community-dwelling older adults and in late-life     depression and Parkinson's disease. This study will involve gathering pilot behavioral and     functional magnetic resonance imaging (fMRI) data in young and older adults performing the     EEfRT task. Understanding the brain mechanisms underlying anhedonia in older adults and in     different patient populations will have a translational impact by elucidating biological     targets for treatment.   "
54748|NCT02569021|"     The purpose of this research study is to test effectiveness of different deep brain     stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the     battery. If these patterns are effective, the implanted batteries will be drained more slowly     and last longer than currently expected. An increase in battery life may reduce the number of     surgeries needed to replace them.   "
54749|NCT02569008|"     This study evaluate the effect of different doses of crystalloids on the changes on cardiac     output (CO) and on the proportion of responders and non-responders and aims to determine the     minimal volume required to increase the mean systemic filling pressures (Pmsf) in     post-cardiac surgical patients.   "
54750|NCT02568995|"     Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality     after hip joint replacement is low but some complications remain, including chronic     post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4).     Strategies that have been identified to reduce morbidity and mortality include: posterior     surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and     the use of spinal anesthesia (5). One of the important factors for patient satisfaction with     lower limb arthroplasty is good postoperative pain management (6). Poorly managed     postoperative pain can lead to chronic post-surgical pain and therefore aggressive     postoperative pain management is important (7). Several different methods have been used to     treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a     combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory agents     (NSAID) injected systematically peri-articularly has been used for pain management with     variable success (8). We found that better analgesia could be achieved when using LIA     compared to intrathecal morphine during the first few days postoperatively (9,10).      Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to     reduce pain intensity and may be considered by many to be a standard of care. Specifically,     the 3-in-1 block has been commonly used because of its ease of application and good pain     management following total hip arthroplasty. The present study aims to compare postoperative     pain intensity following local infiltration analgesia with a standardised 3-in-1 block for     total hip arthroplasty.   "
54751|NCT02568982|"     This study aims at investigating the complications of Cushing's disease in de novo     patients. A series of investigations will assay before treatment and every year thereafter     during a 3 years follow-up period the various complications of the disease. These     investigations will determine the presence and severity of cardiovascular, metabolic, and     bone complications as well as the Quality of Life. Outcome of these complications after     treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.   "
54752|NCT02568969|"     The major combined interventions are between challenging and high-risk aspects of current     cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and     technical features influencing the surgical approach as well as cardiopulmonary bypass (CPB),     anesthesia, and respiratory support.      Plasma lactate concentration is a routine clinical indicator of the tissue oxygen shortage,     and is routinely monitored in virtually all in-risk surgical and ICU patients. However, the     discrete measurement of these values among with other biochemical values has a major drawback     and continuous measurement can be beneficial.      The aim of our study is to assess the clinical usefulness and rationale for routine use of     continuous monitoring of lactate in high-risk combined/complex cardiac surgery.   "
54753|NCT02568943|"     The purpose of this study is to provide oral panobinostat (PAN) treatment to relapsed or     relapsed and refractory multiple myeloma patients who are without satisfactory treatment     alternatives prior to the commercial availability* and reimbursement of panobinostat during     the regulatory approval process. This protocol will acquire additional safety data on the use     of panobinostat in combination with bortezomib (BTZ) and dexamethasone (Dex) in patients with     relapsed or relapsed and refractory multiple myeloma. In this protocol, PAN must be     administered in the defined regimen in combination with both BTZ and DEX.      *(Note: throughout this protocol commercially available means local health authority     approval and a functional method for reimbursement)   "
54754|NCT02568930|"     The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in     older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation     (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination     therapy [DT]) and their caregivers. Our study will contribute to better patient-centered care     of older advanced HF patients and their caregivers, by informing decision making and guiding     strategies to enhance post-operative HRQOL.   "
54820|NCT02568072|"     This project will expand on research conducted by the investigators' group, where the     investigators have demonstrated increased LV trabeculation, satisfying currently existing     criteria for LV Non-Compaction Cardiomyopathy (LVNC), in groups exposed to high cardiac     workloads. To the investigators' knowledge, this will be the first prospective study aiming     to demonstrate a direct relationship between high levels of exercise and increased LV     trabeculation. This study may add weight to the theory that this entity currently described     as LVNC, is a morphological epiphenomenon common to many distinct myocardial remodeling     processes associated with increased cardiac preload and afterload and may better define     normal adaptive increases in LV trabeculation.   "
54755|NCT02568917|"     Background: Dental caries is still a public health problem among Brazilian children and     doubts still exist regarding the most effective restorative technique. The aim of this     pragmatic randomized clinical trial is to evaluate the effectiveness of single and     multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART)     premises compared with Conventional Treatment (CT) in primary and permanent teeth.      Methods: A total of 1,214 5-to-13 years-old children with at least one single or     multiple-surface dentin caries lesion in primary or permanent molars will be selected in the     public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT     (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained     dentists in a dental office inside the schools. The restorations will be evaluated after 6,     12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth     survival, the cost-effectiveness analysis between the two groups and the operator preference     of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival     analysis and log-rank test will be applied to the survival of restorations. All the average     event rates in the two groups will be modelled and compared with a Cox proportional hazard     shared frailty model since there is an operator cluster-effect. The significance level for     all analyses will be 5%.   "
54756|NCT02568904|"     Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to     inflammation and immune dysfunction as well as the typical hangover symptoms.   "
54757|NCT02568891|"     In end-stage renal disease (ESRD) cardiovascular and infectious complications are common. The     gut microbiome might play an important pathophysiological role. ESRD is hypothesized to be     associated with profound alterations of gut microbiome and gut permeability. The     investigators aim to test whether a multispecies probiotic mixture is able to revert the     microbiome changes and decrease gut permeability. Furthermore the investigators aim to test     whether this improvement in microbiome composition and gut permeability is also associated     with improvements in endotoxemia, uremia and cardiovascular risk factors.   "
54758|NCT02568878|"     -  Assess the antidepressant/anxiolytic effect of creatine in male and female          methamphetamine users        -  Assess creatine's effect on methamphetamine use        -  Assess the safety of creatine in male methamphetamine users with depression   "
54759|NCT02568865|"     This project aims to use sensors to monitor physiological signals, sleep patterns, vocal     characteristics, activity, location and phone usage in study patients with depression who are     receiving standard treatment (compared with healthy controls).   "
54760|NCT02568852|"     Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of     pneumoperitoneum on coagulation factors is not well known. In our study the investigators     aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA)     during laparoscopic cholecystectomy(LC) with effect on coagulation factors.      Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under     Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia     (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.   "
54761|NCT02568839|"     The purpose of this trial is to evaluate efficacy and toxicity of either the combination of     docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of     therapy to the opposite treatment alternative is applicable in case of lack of response after     two courses of treatment, or for medical reasons under exceptional circumstances (drug     reaction, other medical conditions) at any point. After termination of the primary treatment     follow-up for five years.      A translational subprotocol is a mandatory part of the study protocol, with exception for the     use of PET-CT evaluations.   "
54762|NCT02568826|"     This is a prospective cohort study, open-label, uncontrolled proof of concept trial. The     trial objective is to evaluate the analgesic tolerability, safety and activity of IDN 5243     (3-glycosyl-3-O-demethylthiocolchicine derivative)administered intramuscularly at 4 mg b.i.d.     for 5 days in the morning (8.00-10.00 AM) and in the evening (6.00-8.00 PM) in subjects with     Low Back Pain (LBP).   "
54763|NCT02568813|"     Epilepsy is a multifaceted disorder and a major public health problem. In addition to     recurrent and unpredictable seizures, abnormalities in psychiatric status, cognition and     social-adaptive behaviors are potential major sources of disability in children and adults     with epilepsy disorders. Recent studies have unequivocally documented raised psychiatric     comorbidities in children with epilepsy, particularly emotional regulation disorders such as     depression and anxiety, as compared to both the general population and the children with     other medical disorders, neurological and non-neurological. A prevalence of 12% to 35% has     been reported, compared to 3-8% in the general population.      Major advances have begun to uncover the potential mediators of emotional regulation     disorders and social comorbidities in epilepsy, but important gaps remain in the early     detection, treatment and prevention of these disorders. A very small number of investigations     have examined children with epilepsy at or near the time of diagnosis. This is a time during     which the effects of chronic epilepsy, potential averse social effects of epilepsy, and other     complicating aetiological effects are minimized.      Epilepsy syndromes provide a useful framework for considering the risk and type of emotional     dysregulation comorbidities. But variability within and across syndromes needs to be taken     into account thus requiring a strict phenotyping by specialists in the filed of pediatric     epileptology. Retrospective studies, usually including patients with chronic epilepsies and     suffering from a mixed spectrum of epilepsy syndromes introduce biases leading to rather     disparate findings.      Are such disorders the result of common physiopathological mechanisms, which precede the     development of the epilepsy? The link between an underlying brain disorder and psychiatric     comorbidities has emerged in recent literature, with evidence based on studies in adults,     suggesting bidirectional relations between epilepsy and neurobehavioural comorbidities.     Emotional regulation disorders can follow the onset of epilepsy, but they can also precede     it, thus serving as a possible risk factor. The clinical implication of such a bidirectional     association is that neurobehavioural comorbidities might be present at diagnosis and even     before epilepsy onset. There is a need for greater understanding of the causes of these     conditions in younger people.      The degree to which specific epilepsy syndromes are associated with the relative risk of     emotional dysregulation disorders in children with new- or recent-onset (within six months     prior to enrolment) has rarely been comprehensively examined and represents the focus of the     current investigation.      The investigators study will be based on a prospectively recruited cohort of 280     children/adolescents with recently diagnosed epilepsy. All participating centres dispose of     the necessary competences for a precise diagnosis of the epilepsy syndromes and the tools for     a per case appropriate aetiology screening. Following a first seizure children are usually     first examined at hospital based emergency departments. Prompt referral to the epilepsy teams     participating at the present study will significantly reduce the population biases and     shortcuts encountered in studies that recruited patients with chronic epilepsy followed in     tertiary care epilepsy units.      The investigators expect their results to provide a greater understanding of both the shared     and the unique features of emotional regulation disorders, in relation to specific epilepsy     categories defined on the basis of the underlying physiopathological mechanisms.      Such knowledge will also assist clinicians and families in the planning of both diagnosis and     management resources.   "
54764|NCT02568800|"     It is advocated that prolonged infusion of beta-lactamic antibiotics provides better     bactericidal effect. The aim of the present study is to randomize patients a to extended     cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting     more than thirty minutes) and evaluate the clinical efficacy of this theoretical     pharmacokinetic advantage.   "
54765|NCT02568787|"     The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound     (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This     nutritional supplement is made from a water soluble extract of rice bran that has been     partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake     mushroom.   "
54766|NCT02568774|"     This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms.     Participants will be put into groups randomly and compared. There are two groups: traditional     acupuncture and usual care. The ratio of group allocation is 1:1.   "
54767|NCT02568761|"     A randomized single blind clinical trial, with a larger sample size than previous studies ,     to evaluate the effectiveness of injection snoreplasty in the treatment of patients with     snoring and obstructive sleep apnea/hypopnea syndrome (OSAHS) compared to oropharyngeal     exercises, a low cost therapeutic modality.   "
54788|NCT02568488|"     Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three     criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The     criteria were as follows:        1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles          per year or amenorrhoea (cycle length > 12wks),        2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels        3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than          eight follicles in an ovary ranging from 2-10mm).      the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months.     Blood samples were collected at the start of the study, before receiving metformin, where     baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) ,     total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian     Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and     6 months respectively of metformin treatment , to asses its effect on serum levels of the     previously mentioned hormonal parameters.   "
54768|NCT02568748|"     Hepatocellular carcinoma (HCC) is the fifth most common malignancy in the world and the third     most common cause of cancer-related deaths complicating liver cirrhosis in most cases. In     Egypt, there has been a remarkable increase of the proportion of HCC among CLD patients from     4.0% to 7.2% over a decade. This rising proportion may be explained by the increasing risk     factors such as the emergence of HCV over the same period of time, the contribution of HBV     infection, improvement of the screening programs and diagnostic tools of HCC as well as the     increased survival rate among patients with cirrhosis to allow time for some of them to     develop HCC. The only curative treatment modalities for HCC are surgery, local ablation, and     liver transplantation which have high recurrence rate either due to viral hepatitis infection     or cirrhosis leading to low success rate and high economic burden.      Unfortunately, the majority of patients have unresectable disease at diagnosis. So, patients     search for palliative very expensive therapies including chemotherapy and radiotherapy which     often fail to eradicate tumor lesions completely and tend to result in many adverse     events.Thus, novel approaches for treatment options are needed for patients with advanced HCC     .      In recent years, immunotherapy has emerged as an efficacious treatment modality with     encouraging efficacy and slight adverse events in cancer therapy [Stroncek 2010].     Cytokine-induced killer CIK cells therapy has been evaluated as an adoptive cell     immunotherapy for cancer patients in a number of clinical trials and the promising efficacy     of CIK cells on malignancies has been proved.   "
54769|NCT02568735|"     The main purpose of this study was to determine the plasma and central nervious system     pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect     on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers     both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their     efficacy in postoperative pain treatment.   "
54770|NCT02568722|"     The objectives of this trial are to determine whether, in critically ill patients with severe     acute kidney injury (AKI), randomization to accelerated initiation of renal replacement     therapy (RRT), compared to standard initiation, leads to:        1. Improved survival (primary outcome); and        2. Recovery of kidney function (principal secondary outcome), defined as independence from          RRT at 90 days   "
54771|NCT02568709|"     The specific aim of this proposal is to investigate the neurophysiological mechanisms of     oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using     magnetoencephalography.      Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala     hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will     be normalized.      Hypothesis B: When OT is administered to patients with schizophrenia, the decreased     functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.      By elucidating the neurophysiological mechanisms of OT administration on emotional face     processing, investigators will bee able to:        1. understand the pathophysiology of the functionally debilitating social cognitive          deficits of schizophrenia,        2. test the efficacy of OT in normalizing the neural abnormalities underlying these social          deficits, and        3. develop and optimize novel treatments for these currently untreatable deficits.   "
54772|NCT02568696|"     The purpose of this study is to investigate local activation of the coagulation system in the     kidney graft during organ preservation and during early reperfusion in adult kidney     transplantation. Generation of thrombin and fibrin as well as activation and inhibition of     fibrinolysis will be investigated. Influence of these events on delayed graft function (DGF)     and acute cell-mediated rejection will be evaluated.   "
54773|NCT02568683|"     This study will evaluate the safety of entospletinib (ENTO) with vincristine (VCR) in     participants with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL).   "
54774|NCT02568670|"     This is a single-center, open label, prospective, randomized, noninferiority controlled trial     with cost-effectiveness analysis to verify if is non inferior to remove peripheral     intravenous catheter according to clinical signs in relation to every 96 hours.   "
54775|NCT02568657|"     Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide     reaching as high as 60% in some countries.      Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre     or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should     be considered a PPH.      In 2012, WHO updated the guidelines for the management of PPH and retained placenta to     include: The use of intrauterine balloon tamponade is recommended for the treatment of PPH     due to uterine atony. This recommendation is now stronger than the previous guidelines. It     can be used for women who do not respond to uterotonics or if uterotonics are not available.     This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a     higher-level facility.Furthermore, FIGO included Uterine balloon tamponade as a recommended     second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.      In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and     Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored     design that enables conservative management of uterine bleeding in cases of uterine atony and     other causes of PPH.      The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a     wide variety of causes in resource-poor settings.      One of the new methods that could be used to control PPH is Uterine packing with     chitosan-covered gauze or Celox.      Celox Haemostats are dressings with natural material called chitosan to control major     haemorrhage including life-threatening bleeding . They are simple and effective, stopping     major bleeding.It was first used by military forces to stop sever bleeding in the scene with     no other options to stop bleeding. Celox™ granules are actually very high surface area     flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to     make a gel like clot, without generating any heat. Celox™ does not set off the normal     clotting cascade, it only clots the blood it comes directly into contact with. Celox works on     casualties using anticoagulants and anti-platelet therapy such as aspirin .   "
54776|NCT02568644|"     The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen     for the treatment of headache and other symptoms related with migraine attacks.   "
54804|NCT02568280|"     This trial is conducted in Europe. The aim of the trial is to investigate the postprandial     glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1     diabetes.   "
54806|NCT02568254|"     This is a single-site, 8-visit, double-masked, cross-over study involving three marketed     products as study lenses. Participants will be randomly assigned each lens type, which will     be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum     washout period of 3 days before entering the study and undergo a minimum 7 day washout period     between dispensing each lens type.   "
54821|NCT02568059|"     The clinical safety of Sahastara remedy alcoholic extract in healthy volunteers.     Investigators will investigate safety of 100 and 200 mg of Sahastara remedy extract capsule     in healthy volunteers. This is Clinical trial Phase I.   "
54777|NCT02568631|"     The serious game JeStiMulE (Educational Game for Multisensory Stimulation of Children with     developmental disorders), developed by the Autism Resources Center of Nice, was created to     teach social cognition including emotion recognition in context, for children and adolescents     with autism. In a previous study, JeStiMulE has demonstrated efficacy in a population of     young people aged 6-17 years old with high and low levels of autism.      According to the recommendations of the 2011 HAS, disorders of social interactions are the     most persistent troubles of the autistic triad in life.      It seems essential to us to be able to offer young adults with autism, rehabilitation methods     adapted to their trouble, and to observe whether JeStiMulE could be one of them.      This study researches the effectiveness of the serious game JeStiMulE in the improvement     social cognition for adults with autism versus controls.      The main goal is:      - Comparing the improvement in social cognition among adults with autism using the serious     game JeStiMulE or not.      Two groups will be formed: a first one of fifteen adults with a diagnosis of autism     objectified, this group will use JeStiMulE and will be compared to a control group of adults     with autism, using another video game, not aimed to improve social cognition.      The objective of JeStiMulE players will be ending the game after a learning period and two     playing periods (with emotional words and idioms, including three modules each). The groups     will be matched with their nonverbal IQ through Raven matrices and visual memory tasks     (WAIS).      The control group will also be stimulated through a video game, not specialized in improving     social cognition.      The primary outcome will be assessed by the emotion recognition at the FEEST of Ekman test:     by the number of emotions recognized on faces, compared to the number of emotion presented     through this test.      The secondary outcomes will be:        -  The rest of social cognition improvement by several tests (the theory of mind with the          score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a          self-administered questionnaire: EQ / AQ).        -  The impact on the quality of life, verbal fluency of emotional words, and the feedback          from JeStiMulE players will also be seen as a secondary outcome.   "
54778|NCT02568618|"     This study utilizes the Medication DNA Insight™ tests for pain and mental health medications.     We are testing the pain and mental health medications commonly used in pain treatment.     Subjects will give a sample of saliva that will be tested for the metabolism of the different     medications. Consented providers will be given the results of the test and can determine     whether to change the subject's medication regimen. Providers and subjects will be ask to     complete surveys both pre and post visits. The purpose is to examine provider and patient     satisfaction, confidence and certainty of using the test results.   "
54779|NCT02568605|"     Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the     liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD.     Part of the metabolic dysfunction may arise through changes in the gut microbiota. Prebiotic     fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota;     therefore they may have potential as part of a dietary strategy for NAFLD treatment.   "
54780|NCT02568592|"     The capacity to burn fat as fuel for exercise may have important implications for sporting     performance, with dietary fat intake positively influencing this ability.      Endurance performance and the ability to burn fat will be measured in women runners following     the consumption of 3 diets varying in the amount of fat and carbohydrate.   "
54781|NCT02568579|"     This study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%)     breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of     life from birth until 12 month age. Visits - Subjects will be consented prior to delivery,     visit 1. Subject will be seen if possible after delivery for instruction on stool collection     and distribution of supplies, visit 2. Subject will be seen at 6 months of age post     immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact     via phone/email to collect information about feeding changes.   "
54782|NCT02568566|"     This phase IIA trial studies how well a recombinant human papillomavirus nonavalent works in     preventing human papilloma virus (HPV) in younger healthy participants. HPV is a common virus     which usually causes infections that last only a few months, but sometimes can last a long     time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among     adults. Recombinant human papillomavirus nonavalent vaccine is a type of nonavalent vaccine     (a vaccine that works against nine different viruses or other microorganisms) and may protect     against HPV infection and the health problems that HPV infection can cause.   "
54783|NCT02568553|"     This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab     when given together in treating patients with non-Hodgkin lymphoma that has returned after a     period of improvement. Biological therapies, such as lenalidomide and blinatumomab, use     substances made from living organisms that may stimulate or suppress the immune system in     different ways and stop cancer cells from growing.   "
54784|NCT02568540|"     Today's mobile devices (especially smartphones) are powerful ways to communicate new     information to medical researchers. For this study, researchers at Boston Children's Hospital     are asking people with hepatitis C to make use of their smartphones to help report     information about themselves that may improve how hepatitis C is treated. This study uses a     free app called C Tracker that can be installed from the Apple App Store onto the     participants iPhone. The main goal of this research study is to use this app to report     hepatitis C related health information to the researchers who are conducting this study. The     investigators will ask participants about their health,activities, medications, and ways in     which hepatitis C has impacted you. This information will be reported anonymously, which     means that the researchers doing the study won't know who the participants are.   "
54785|NCT02568527|"     The purpose of this clinical study is to undertake a pilot safety and efficacy study of a     synthetic biodegradable membrane as a substitute for using donor human amniotic membrane     (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly     excised limbal tissue in theatre as a one stage procedure   "
54786|NCT02568514|"     In this study, the investigators will conduct a randomized, controlled trial to evaluate the     impact of offering mobile secure text messaging on clinical outcomes.   "
54787|NCT02568501|"     In this study the investigators will compare a novel approach using daily financial     incentives and a tiered sponsor network to motivate adolescents and young adults with type 1     diabetes to improve glycemic control.   "
54818|NCT02568098|"     Primary Objective        -  To evaluate the safety and tolerability of co-administered single dose          Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and          Albendazole (ABZ) in healthy subjects.      Secondary Objectives        -  To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ, and          ABZ in healthy adult subjects.        -  To characterize the pharmacokinetic properties of PQ (and its major metabolite),          DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination.        -  To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM,          ABZ and their metabolites.        -  To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against          Anopheles dirus and Anopheles minimus.        -  To determine if IVM concentrations in venous blood differs from capillary blood.   "
54789|NCT02568475|"     This study addresses the Patient-Centered Outcomes Research Institute (PCORI) area of     interest related to development of decision support tools that bring patients, families and     clinicians together to decide, in this instance, whether or not transfer from the nursing     home (NH) to acute care is necessary and appropriate. The purposes of this study were 1) to     develop an evidence-based decision aid addressing potentially avoidable transfers of     residents from nursing homes to hospitals (preceded this protocol), and 2) to evaluate this     decision aid in terms of acceptability to residents and families and its effect on the     quality of transfer decisions.      The primary hypotheses to be tested are:      Hypothesis 1: Resident and family members in the intervention group will report greater     preparation for decision making and less decisional conflict than those in the no treatment     control group.      Hypothesis 2: Residents and family members in the intervention group will demonstrate     increased knowledge related to acute care transfer and less preference for acute care     transfer than those in the no treatment control group.   "
54790|NCT02568462|"     The purpose of this study is to evaluate the safety and performance of a new version of a     coronary artery stent for treating blockages in the arteries supplying blood to the heart     muscle. The Amaranth Medical APTITUDE scaffold releases a drug (sirolimus) to reduce the     likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold     dissolves away over time, leaving no permanent implant after the blood vessel has healed.   "
54791|NCT02568449|"     This phase II trial studies how well nintedanib works in treating patients with malignant     pleural mesothelioma that has come back. Nintedanib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
54792|NCT02568436|"     26 participants from the Orthodontic Department at University of Damascus Dental School will     be randomly assigned into two groups. In the experimental group, a low level laser with a     wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15     seconds per point will be applied on each tooth of the six upper incisors according to this     protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be     applied in the center of each half from both the buccal and palatal sides which means 4     application points and a total energy of 8 j per each tooth. Control group will undergo     typical orthodontic treatment with the laser device applied the same manner but without being     turned on (to get the placebo effect for pain reduction effect). This procedure will be     repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the     end of the leveling and alignment stage.   "
54793|NCT02568423|"     The main purpose of this study is to explore the safety and tolerability of mirikizumab in     healthy Japanese and Caucasian participants. The study will also estimate how much     mirikizumab gets into the blood stream and how long it takes the body to remove it. The study     is expected to last about 16 weeks for each participant.   "
54794|NCT02568410|"     Platelets are increasingly recognized as a potent and ubiquitously present source of     inflammatory activation. Importantly, antiplatelet therapy has been shown to significantly     reduce major adverse events such as renal injury in cardiac surgery patients. However, in     current practice, concerns of excessive bleeding—not platelet activation and thrombosis—shape     clinical decisions.      The investigators have recently seen, that a significant drop in platelet numbers following     cardiac surgery is associated with increased mortality and risk of acute kidney injury. The     investigators hypothesize that such thrombocytopenia is a result of excessive perioperative     platelet activation and resultant release of inflammatory and tissue injurious signals by     activated platelets. Platelet activation will be characterized during and after cardiac     surgery and examine its correlation with inflammatory responses and perioperative end-organ     injury.   "
54795|NCT02568397|"     The purpose of this study is to learn about the effect of lanabecestat on how the body     absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat     when they are taken together. This study will last about 28 days and participants will be     asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3     occasions. Screening is required within 30 days prior to the start of the study.   "
54796|NCT02568384|"     The purpose of this study is to assess the usability of the Onyx system in the hands of     subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with     Non-IDDM.   "
54797|NCT02568371|"     The bio-Share project aims at collecting blood samples in students participating in the     i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable     investigators in the future to study biological determinants of conditions that affect young     adults and to test certain hypotheses on the pathophysiology and mechanisms underlying     diseases occurring both at a young age and later in life (as early exposures may also impact     late onset diseases)   "
54798|NCT02568358|"     Lung transplantation (LTx) , DNA-based testing.      Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard     testing.      Experimental intervention: DNA-based testing of BAL fluid.   "
54799|NCT02568345|"     The purpose of this study is to determine the minimum effective dose of sugammadex, an     antagonist of neuromuscular blockade used during anesthesia practice, in obese patients,     considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg     but no studies were found with obese patients.   "
54800|NCT02568332|"     This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines     AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV)     seropositive individuals. This study also aims to assess the cellular immune response     generated by these vaccines when administered as mentioned above.   "
54801|NCT02568319|"     This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese     subjects.   "
54802|NCT02568306|"     This trial is conducted in the United States of America. The aim of the trial is to     investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the     body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but     otherwise healthy subjects.   "
54803|NCT02568293|"     The purpose of this study is to compare balloon angioplasty plus SBCV against balloon     angioplasty alone for treatment of stenosis within the femoropopliteal artery.   "
54808|NCT02568228|"     Intake of omega-3 (n-3) polyunsaturated fatty acids (PUFAs) from fish oil and fish are     associated with significant health benefits in risk of cardiovascular disease. However, both     lean and fatty fish have been shown to have beneficial effects suggesting that not all     effects are mediated by n-3 PUFAs. Krill oil is an n-3 PUFA supplement on the marked. The n-3     PUFAs from krill oil is in the form of phospholipids, and these fatty acids may be more     readily and effectively absorbed after ingestion than n-3 PUFAs in the form of     triacylglycerols from fish oil. Fish also contain many other potential health components than     n-3 PUFAs such as taurine and vitamin D, iodine, selenium and more unspecified components     such as bioactive peptides which can mediate the health beneficial effects observed after     intake of fish.      The present study aims to elucidate the cardiovascular health beneficial effects after     consumption of fish (lean and fatty) and krill oil, with regard to effects on plasma lipids     and other markers of cardiovascular health such as inflammatory, haemostatic and endothelial     dysfunction markers. The investigators will perform whole genome transcriptome analyses in     peripheral blood mononuclear cells (PBMCs) in order to further understand the cardiovascular     health benefits and elucidate the mechanisms of action.   "
54809|NCT02568215|"     This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)     VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.   "
54810|NCT02568202|"     This study is conducted in the United States of America (USA). Tha aim of this study is     bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).   "
54811|NCT02568189|"     Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the     inferior vena cava impacts the management and outcomes of pediatric emergency department     patients undergoing evaluation and treatment of sepsis and gastroenteritis associated     dehydration.   "
54812|NCT02568176|"     The primary purpose of this study is to evaluate the induction potential of repeated     administration of intranasal esketamine on cytochrome P450 (CYP) 3A4 and CYP2B6 activity in     healthy participants using orally administered midazolam and bupropion as probes,     respectively and to evaluate the pharmacokinetics of esketamine after a single dose and     repeated administration.   "
54813|NCT02568163|"     Treatment of periodontal diseases is influenced by several risk factors. Psychological stress     is considered as one of them. Aim of this study is to assess if stress influences results of     non surgical periodontal treatment in severe chronic forms of periodontitis.   "
54814|NCT02568150|"     Evaluate onset time and safety of improvement effect of each group's forehead wrinkles after     2, 3, 4, 5, 14 days from administration of 20U dosage of DWP450-004 for adult patients who     need more than moderate improvement of forehead wrinkles.   "
54815|NCT02568137|"     This research seeks to develop a culturally-acceptable, effective, and sustainable way of     utilizing the rapidly growing penetration of mobile phones among people in Sub-Saharan Africa     (SSA), to improve the currently poor control of hypertension among patients at high risk for     future stroke. It also aims to develop human capital in SSA to conduct locally-relevant,     high-quality stroke research in the future. Specifically, this study will preliminarily test     a strategy that incorporates mobile phone texting and home blood pressure monitoring directed     by trained nurses, to improve patient adherence to proven medical therapies for treating     hypertension.   "
54816|NCT02568124|"     BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial     neurosurgical consult. There is no widely accepted medical treatment for CSDH.      This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH     resolution following conservative management, lower the number of required surgical     procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a     double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to     provide preliminary efficacy data as well as feasibility, safety and incidence data required     to plan a larger definitive phase III trial.      METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke     with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be     screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic     disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be     randomized to receive either 750 mg of TXA daily or placebo until complete radiological     resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial     CT scanning. Cognitive function tests, quality of life questionnaires as well as functional     autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months     post-treatment follow-up. During the treatment period, patients will undergo standard CSDH     management with surgery being performed at the discretion of the treating physician. If     surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.      The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned     surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation     procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life,     incidence of complications and length of hospital stay. Planned subgroup analyses will be     performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised     CSDH.      DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment     has yet to be discovered. The TRACS trial will be the first prospective study of TXA for     CSDH.   "
54817|NCT02568111|"     The primary objective of this study is to evaluate the Injection Related Erythema (IRE)     mitigation effect of a single administration of brimonidine tartrate in comparison with a     vehicle gel (placebo).      The secondary study objectives are to evaluate the IRE mitigation effect of a single     administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent     definition scale, in accordance with the primary endpoint of the original brimonidine pivotal     trials and participants' satisfaction with the overall appearance of their skin.   "
55324|NCT02561494|"     Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the     total intravenous anesthesia (TIVA).      The investigators will evaluate whether the nefopam can decrease the total amount of     remifentanil administered during the operation, which will reduce the acute opioid tolerance     and following consumption of fentanyl during postoperative period.   "
54819|NCT02568085|"     This is a single-blinded randomized controlled trial to evaluate the effectiveness of Arista     hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) in reducing     drainage output after total thyroidectomy with and without lateral neck dissections.     Increased drainage in total thyroidectomy and neck dissection wound beds can lead to seroma     formation with possible secondary infection, delayed hospital discharge, and additional home     care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic     powder that can be easily applied to broad surgical fields to reduce bleeding and seroma     rates. Therefore, its application to thyroidectomy and neck dissection wound beds may bear     significant potential benefit.   "
54822|NCT02568046|"     This is a phase 1b/2a study investigating the safety and effect of Sym004 in combination with     FOLFIRI (chemotherapy) when administered every second week.   "
54827|NCT02567981|"     Adequate nutrition during the first years of life is essential to reach full body and brain     development potential. Children under the age of 5 in Central America and El Salvador suffer     from micronutrient deficiencies. In El Salvador, ~ 20% of children under the age of 5 suffer     from chronic undernutrition which is reflected in low length-for-their age Z-scores and     anemia. This trial will examine the impact on health and growth in young children that will     receive either a 21 micronutrient fortified cereal/legume mix manufactured in Guatemala or     the current standard of nutritional care. The ultimate goal is to identify other feasible and     effective alternatives to prevent micronutrient deficiencies through culturally acceptable     vehicles.   "
54828|NCT02567968|"     At present clinicians have no way to reverse anesthesia. Patients wake when their bodies     clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and     other cognitive problems after waking from anesthesia. In studies on animals, the     investigators observed that caffeine caused rats and mice to wake much more rapidly from     anesthesia. This was true for all the animals tested. The investigators would like to see if     this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse     the cognitive deficits associated with anesthesia, after waking?      The investigators hope to start with a very modest pilot program. Each volunteer will be     anesthetized twice. Each volunteer will be anesthetized one time and allowed to wake without     the aid of any other drugs and the other time they volunteer will receive a relatively low     dose of caffeine after anesthesia.      If no adverse effects are observed in the Pilot program, the investigators will expand the     study. At this dosage of caffeine, animal studies suggest approximately a dozen volunteers     will be required to complete the study.   "
54829|NCT02567955|"     A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on     immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine     (Cervarix) are available. The main objective of this study is to assess the immunogenicity of     ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys     according to 0-6 month schedule.   "
54830|NCT02567942|"     Anesthetics agents has variety inflammation during the cancer surgery. This perioperative     inflammation can influence to cancer metastasis or recurrence.      The purpose of this study is to prove the variation of immune cell activity between     preoperative and postoperative period.   "
54831|NCT02567929|"     Anesthetics agents has variety inflammation during the cancer surgery. This perioperative     inflammation can influence to cancer metastasis or recurrence.      The purpose of this study is to prove the variation of immune cell activity between     preoperative and postoperative period.   "
54832|NCT02567916|"     The purpose of this study is to compare the incidence and intensity of possible pain on     injection as well as patient satisfaction caused by long chain triglyceride propofol versus     medium/long chain combinated triglyceride propofol on endoscopy.   "
54866|NCT02567474|"     This study evaluates the effectiveness of self management programs based on 5A model on the     lung function status, dyspnea and exercise tolerance in Chronic Obstructive Pulmonary Disease     patients. Participants were randomly assigned to an intervention group or a control group.     The control group were receiving standard practice care and the intervention group were     receiving intervention in addition to standard practice care. The intervention content     include implementation of a self management plan based on 5A model.   "
54833|NCT02567903|"     Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with,     according to the American Society for Sports Medicine, over 4 million procedures performed     each year. The risk of venous thrombosis following this procedure is considerable with rates     of symptomatic events varying between 0.9% and 4.6%. It is currently unknown how this high     risk comes about considering its short duration and minimal tissue damage caused by the     procedure. A factor that may play a role is the use of a tourniquet. A large majority of     orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of     a tourniquet. Tourniquet applied surgery is not without risks. Although its use during     orthopedic surgery is widely accepted and a standard procedure, tourniquet use can lead to     loss of muscle functional strength and contractile speed, vessel wall damage and nerve     injury, next to the possibly increased risk of venous thrombosis. In the proposed study the     investigators will investigate the effect of a tourniquet on local and systemic markers of     hypoxia, inflammation, involvement of endothelium, and coagulation activation. A finding of     more prominent activation of the coagulation system with tourniquet use than with non-use     will create an important opportunity to prevent thromboembolic events in these patients, as     it has been shown that knee arthroscopy can be performed adequately without the use of a     tourniquet. Furthermore, it will increase the understanding of the pathophysiology of     thrombosis.   "
54834|NCT02567890|"     Women in general and young girls in particular are constantly exposed to unhealthy body and     appearance ideals through media that contribute to body dissatisfaction and unhealthy     behaviors such as rigid dieting, which in interaction with genes and other factors increase     the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The     investigators aim is to investigate the extent to which an interactive prevention program,     delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the     emergence of eating disorders among young females. The sBody Project is based on a     Dissonance-Based Intervention: (DBI) that has shown very promising results. The adaptations     and changes in the format of delivery accomplished in this study might help to disseminate     the program on a broad basis, and consequently affect the health of young females on a much     larger scale the ever before.   "
54847|NCT02567721|"     The purpose of this study is to conduct a pilot study to explore the potential use of     routinely collected data in General Practitioner (GP) practices to conduct enhanced safety     surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim     guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.   "
54899|NCT02567045|"     This is a multicenter, controlled, randomized phase III study to compare participation rate     with two screening rounds of fecal occult blood test (FIT) versus one-time screening     colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).      The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is     higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy     and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary     to include in each group.   "
54835|NCT02567877|"     Patients taking thyroid hormone replacement after thyroid removal surgery often report     feeling differently than they did prior to taking thyroid hormone. The symptoms can include     fatigue, worsening mood or subjective brain fog where the patient feels like their thinking     is just not as sharp as it was previously. Multiple studies have found that patients taking     thyroid hormone replacement have a diminished quality of life compared to matched controls.     Previous studies have suggested that the type of deiodinase (DIO) polymorphism a patient has,     which is responsible for converting the thyroid hormone T4 into the more biologically active     T3, may contribute to their overall cognition and sense of well-being. The Investigators aim     to determine if the type of deiodinase polymorphism a patient has contributes to the     patient's cognition and overall sense of well-being after surgery and thyroid hormone     replacement.      Objective: Determine if patients with the deiodinase type 2 CC polymorphism have objective     differences in working memory (N-back test is primary endpoint), cognitive function and sense     of well-being after thyroidectomy when placed on standard thyroid hormone replacement     therapy.      Hypotheses: (1) Patients with the deiodinase type 2 CC polymorphism will have worse working     memory (N-back test is primary endpoint), cognitive function and sense of well-being on     standard thyroid hormone replacement therapy after thyroidectomy compared with before     thyroidectomy.      (2) Patients with the deiodinase type 2 TT or TC polymorphism will have no differences in     working memory, cognitive function or sense of well-being on standard thyroid hormone     replacement before and after thyroidectomy.   "
54836|NCT02567864|"     The goals of this research project were: 1) to develop a senior-tailored Healthy Beat     Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects     of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility,     compliance, and long-term effects of a six-month, DVD-guide HBA exercise program.   "
54837|NCT02567851|"     An early phase II, single arm, two stage study, to investigate the level of activity,     duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent,     utilising a response adapted approach, in older, frailer or co-morbid patients with     previously untreated Hodgkin lymphoma.      Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on     the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks.      At the end of treatment patients will be assessed clinically at 3 months intervals and by CT     scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years,     follow-up will be according to local practice.   "
54838|NCT02567838|"     The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing     pain associated with transrectal ultrasonography (TRS) in gynecologic field.   "
54839|NCT02567825|"     To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management     will meaningfully improve children's acute otitis media (AOM) experience over the succeeding     2 years.   "
54840|NCT02567812|"     The aim of this prospective study is to collect data on in-patients with pelvic inflammatory     disease(PID) at Kangbuk Samsung Hospital.   "
54841|NCT02567799|"     The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral     Suspension when used in combination with standard dose radiation therapy and chemotherapy in     patients with non-small cell lung cancer. Based on preclinical data the investigators     hypothesize that BIO 300 Oral Suspension will reduce the incidence of radiation-induced     pneumonitis and pulmonary fibrosis.   "
54842|NCT02567786|"     Coagulation abnormalities after pediatric open-heart surgery are complex and very often     multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the     coagulation tests during CPB, the younger age has been the most significant risk factor for     bleeding and transfusion requirements. In children the volume of pump priming is much higher     compared with the patient's circulating blood volume. For this reason the CPB tubing system     is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive     hemodilution and induced coagulopathy. While this is routinely performed in neonates and     small infants, the routine priming of CPB system with FFP has been questioned in several     randomized prospective studies in older infants. However, the results of these studies are     conflicting. Moreover, they show methodological issues.   "
54843|NCT02567773|"     GSK2881078 is a selective androgen receptor modulator (SARM) that is being evaluated for     effects on muscle growth and strength in subjects with muscle wasting to improve their     physical function. Part A of this study will evaluate the safety, efficacy and     pharmacokinetics of GSK2881078 in healthy, older men and post-menopausal women who will take     daily dosing for 28 days and be followed for a total of 70 days. Part B of this study will     characterize the effect of Cytochrome P450 3A4 (CYP3A4) inhibition on the GSK2881078     pharmacokinetics. Part B will only be conducted if safe and efficacious dose is identified in     Part A. Part A will include healthy older males and post-menopausal females; and randomize     approximately 60 subjects (about 15 per cohort [4 cohorts]) to complete approximately 48     (about 12 per cohort). Part B will enroll one cohort of approximately 15 healthy male     subjects to complete approximately 12. The study duration will be approximately 115 days for     Part A and 122 days for Part B.   "
54844|NCT02567760|"     This study is set up to determine the cognitive enhancing effect and consumption safety of     the novel cognitive enhancement product made from the combined extract of Z. mays (purple     color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.   "
54845|NCT02567747|"     The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media     (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health     care resources before and after the introduction of vaccination against pneumococcal disease     within the Universal Mass Vaccination (UMV) in Colombia.   "
54846|NCT02567734|"     Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that     uses a series of short but intense electric pulses delivered by NanoKnife generator through     paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis     through irreversibly disrupting cellular membrane integrity. This study aimed to investigate     the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the     treatment of patients with locally advanced tumors in different anatomical position.   "
54861|NCT02567539|"     The study is aimed to evaluate efficacy and safety of re-irradiation for patients with     recurrent high grade gliomas after other treatment.   "
54848|NCT02567708|"     This study is a multi-centre, randomised, double-blind, placebo-controlled (with rescue     medication), two period crossover study in subjects with persistent uncontrolled asthma,     currently not treated with an inhaled corticosteroid (ICS) or long acting beta 2 agonist     (LABA). This study is the first administration of GSK2269557 to asthmatic subjects, and the     aims of the study are to investigate the efficacy, safety, tolerability, and pharmacokinetics     of four weeks of treatment with orally inhaled GSK2269557 1000 microgram (mcg) in subjects     with persistent uncontrolled asthma. In a sub-study, biological mediators will be measured     from induced sputum and blood.      Approximately 50 subjects will be randomised into the study (including approximately 16     subjects in the sputum sub-study). Each subject will complete two treatment periods: subjects     will be randomised to receive GSK2269557 1000 mcg in one treatment period, and matching     placebo in the other treatment period. Each treatment will be administered once daily for 28     days (+/- 2 days) via the DISKUS™ dry powder inhaler (DPI).      The study will consist of a Screening Visit; a Run-in Period (approximately 2 weeks in     duration); two 28-day Treatment Periods (each with 4 clinic visits); a 4-week Washout Period     (between the Treatment Periods); and a Follow-up Visit. The total duration of the study for     each subject will be approximately 16 weeks. DISKUS is a registered trademark of the     GlaxoSmithKline group of companies.   "
54849|NCT02567695|"     The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose     of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100     mg) capsule formulation in healthy fasted subjects.   "
54850|NCT02567682|"     The purpose of this study to evaluate the effect of concomitant administration of GBT440 on     caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a     CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.   "
54851|NCT02567669|"     This study examines the extent of systemic muscle loss and the degree of fatigue experienced     by breast cancer patients undergoing radiotherapy. This study seeks to identify whether     muscle loss occurs outside the radiation fields and if muscle loss is correlated with the     degree of fatigue.   "
54852|NCT02567656|"     The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K     delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.   "
54853|NCT02567643|"     This study is designed to determine outcome for patients with 5 or more central nervous     system (CNS) metastatic lesions treated with stereotactic radiosurgery (SRS).   "
54854|NCT02567630|"     This is a prospective interventional study involving young children who will all receive     non-invasive, passive assessments of sensory and motor function. In addition a subpopulation     of young children with cerebral palsy will participate in a randomized controlled trial of     constraint-induced movement therapy, a routinely prescribed therapy used in clinical practice     for children with motor difficulties. The study attempts to apply a rigorous scientific     approach to study a widely used but poorly studied practice. The design is an RCT with     wait-list controls to allow all children to benefit from the therapy, even if they are     randomized to the control group. All children, regardless of group allocation will continue     with their standard of care occupational and physical therapy throughout the study.   "
54855|NCT02567617|"     The aim of this study was to evaluate the effect of polyphenol supplementation on plasma     levels of prostaglandin E2 in women during the reproductive period.   "
54856|NCT02567604|"     This study will explore experience of AMD caregivers in order to develop a core outcome set     (COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying     to capture what research outcomes are important from their perspective.      People 18 years of age and older who have been AMD caregivers for at least 6 months may be     eligible for this study.      The aim is to conduct three focus groups lasting approximately one hour. The plan is to enrol     18-24 participants (6-8 participants per each of 3 focus groups).Two researchers will be     involved in conducting the focus groups. A moderator will ensure fluid discussion, while the     second investigator will be taking notes and audio-recording the discussion.   "
54857|NCT02567591|"     Physical exercise has been identified as a major beneficial factor in the management of     patients suffering from many chronic diseases especially cancer and in the context of cardiac     or pulmonary transplantation. It contributes to an improvement of the quality of life and     decreases treatment side effects and mortality. Aerobic fitness is constantly altered in     cirrhotic patients and correlated to the severity of the hepatic disease. Moreover, in this     setting, other etiological factors may be added like chronic obstructive bronchitis and     alcoholic cardiomyopathy. In this population, muscle abnormalities with fatigue and cramps     have been described. Muscle weakness in this condition may be comparable to that described in     patients with chronic obstructive bronchitis and contributes to the decrease of aerobic     fitness. Different causes such as muscle deconditioning, hypoxemia, denutrition,     anti-rejection drugs increase this phenomenon after liver transplantation. Finally, the     aerobic capacity or VO2max is a prognostic factor for survival and is linked to the number     and the length of hospitalizations after liver transplantation (LT).      Therefore, physical activity is a valid and relevant way to improve quality of life, increase     survival, and limit costs of hospitalizations. The aim of this study is to assess the effects     of a personalized physical activity retraining program on aerobic capacity, strength and     fatigue, in a population awaiting liver transplantation.      Purpose: The hypothesis is that an at home adapted retraining program conducted before LT,     and including physical activity (aerobic and strength training), will improve aerobic     fitness, peripheral strength, quality of life and decrease the hospitalization length in     intensive care unit after LT.   "
54858|NCT02567578|"     This is a multicenter, randomized, double-blind, placebo-controlled dose-finding phase 2     trial to evaluate the efficacy and safety of YH12852 in patients with functional dyspepsia.   "
54859|NCT02567565|"     This study will compare cataract patients before and after phacoemulsification. Evaluations     will be performed before and 1 and 3 months following cataract surgery, including measurement     of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and     conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the     Ocular Surface Disease Index.   "
54860|NCT02567552|"     Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus     intramuscular progesterone 50 mg/day, to determine whether there are differences in the     endometrial transformation and endometrial receptivity.   "
54862|NCT02567526|"     Inadequate food and fluid intake is a common problem among nursing home (NH) residents and     one that can lead to under-nutrition, dehydration, weight loss, hospitalization, and even     death. The most common nutrition intervention for at-risk NH residents is oral liquid     nutrition supplementation, although, there is limited controlled evidence of the efficacy of     supplements in promoting weight gain in NH residents. Moreover, studies show that supplements     are not provided consistent with orders and residents receive little to no staff assistance     to promote consumption in daily NH care practice. The result is that nutritionally at-risk NH     residents with supplement orders receive few additional daily calories from supplements.     Recent evidence strongly suggests that offering residents a choice among a variety of foods     and fluids multiple times per day between meals coupled with assistance is effective in     increasing daily caloric intake and promoting weight gain. However, the provision of the     between-meal choice intervention requires significantly more staff time relative to the     amount of time NH staff currently spend on between-meal nutritional care provision.      A new federal regulation allows NHs to train non-nursing staff to provide feeding assistance     care. Preliminary research has demonstrated that non-nursing staff trained as feeding     assistants provide mealtime feeding assistance care that is comparable to or better than     their indigenous nurse aide counterparts. Moreover, a recent demonstration project showed     that these staff can be used to effectively augment nurse aide staff for mealtime feeding     assistance care provision in daily care practice. The proposed translational study will     utilize the federal regulation to train non-nursing staff for between-meal nutritional care     delivery. Specifically, the proposed study will use a controlled, intervention design to     determine the cost-effectiveness of the between-meal choice intervention relative to a usual     care control group in a group of 200 residents across 4 NH sites. Residents with an order for     caloric supplementation will be included in this study and randomized into either a usual     care control group or a choice intervention group (100 residents per group). The usual care     control group will continue to receive standard NH care for supplement or snack delivery     between meals, as provided by indigenous nurse aide staff. Non-nursing staff trained as     feeding assistants will offer residents in the intervention group a choice between     supplements and other snack foods and fluids twice daily, five days per week, for 24 weeks     while also providing a standardized prompting protocol to enhance intake and independence in     eating. Research staff will independently document the costs of intervention implementation     and compare these costs to effectiveness measures which include improvements in caloric     intake, weight and quality of life. These outcomes will be independently monitored for both     groups across 24 study weeks by trained research staff using standardized, validated     protocols. This translational research effort will provide critical information to improve     care practices in nursing homes for nutritionally at risk residents.   "
54863|NCT02567513|"     Low oral food and fluid intake and unintentional weight loss are common problems among     long-stay nursing home (NH) residents and are associated with adverse, costly clinical     outcomes. This study will use a controlled, intervention design to determine the     cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition     intervention that offers NH residents a choice between supplements and other foods and fluids     (i.e., snacks) between meals in a group of 200 residents across 4 NH sites. Residents with an     order for supplementation will be included in this study and randomized into one of three     groups: (1) usual care control; (2) oral liquid nutrition supplementation intervention; or     (3) choice intervention. The usual care control group will continue to receive standard NH     care for supplement or snack delivery. Research staff will provide the same supplements used     by the NH (group two) or a choice between supplements and other foods and fluids (group     three) twice daily, five days per week, for 24 weeks and document the daily costs of     intervention implementation when also providing a prompting protocol known to improve intake     and enhance independence in eating. Based on extensive preliminary data, it is anticipated     that both groups two and three will require significantly more staff time than usual care     (group one). Thus, the labor costs of these interventions will be documented and compared to     effectiveness measures. Effectiveness measures include the following resident outcomes:     improvements in total daily caloric intake, weight, nutrition and hydration status and     quality of life. These outcomes will be independently monitored for all three groups across     24-weeks by trained research staff using standardized, validated protocols.   "
54864|NCT02567500|"     The aim of this study is to show presence of cognitive and emotional factors on the beginning     and persistence of auditory hallucinations in non-psychotic children. Investigators will     describe a significant link between this factors and hallucinations in a sample of     non-psychotic children. The results of this sample will be comparing to another group of     children of the same age, sex and diagnosis, but without hallucination. Finally,     investigators will control the persistence of hallucination on the first group after a six     month period.   "
54865|NCT02567487|"     The aim of the current study is to investigate the effects of two different doses of     levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For     this purpose we planned to include 50 children aged between 2 and 12 that will undergo     unilateral inguinal surgery.      The doses that will be used in the study were within usual dose limits which is stated in     prospectus of the study drug.   "
54867|NCT02567461|"     It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be     treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF).     Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12     receptor inhibitor, respectively. However, over the past years, several non-vitamin K     antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF     showing encouraging safety and efficacy profiles as compared with warfarin. However, the     effects of edoxaban in combination with DAPT in the setting of patients with coronary artery     disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic     treatment strategy, including clopidogrel and stopping aspirin, represents another important     area of clinical interest. This investigation is a prospective, randomized, parallel-design,     open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and     clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin     and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).   "
54868|NCT02567448|"     The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural     changes associated with COPD and upper airway inflammation on upper airway collapsibility.     Upper airway collapsibility is closely associated with development of obstructive sleep apnea     (OSA), which is a common disease characterized by repetitive collapse of upper airway during     sleep, leading to hypoxemia and arousal. OSA has important neurocognitive and cardiovascular     consequences, especially in patients with COPD.      Participants in this research study will undergo two overnight sleep studies (PSGs),     pulmonary function test, and CT scan of the upper airway and chest. The first sleep study     will evaluate the sleep breathing disorder and the second sleep study will measure the upper     airway collapsibility, called critical closing pressure (Pcrit). Pcrit is measured by a     modified continuous positive airway pressure (CPAP) machine which can provide a wide range of     pressures between 20 and -20 cmH2O in order to modify upper airway pressure.   "
54887|NCT02567201|"     Aim : To assess the ability of healthy subjects and patients with a severe motor disability     to voluntary control their attention      Material and Methods:      Population: healthy subjects, patients with brain injury Electroencephalographic study to     research attentional modulation during different kind of stimulation (visual, auditory,     tactile)      Sudy 1: passive recording.      Study 2: active recording (instruction of attentional control given to the subject).      Study 3: active recording with a feedback obtained after a processing of the brain activity.   "
54870|NCT02567422|"     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970     (VX-970) when given together with cisplatin and radiation therapy in treating patients with     human papillomavirus negative (HPV) (-) head and neck squamous cell carcinoma that has spread     from where it started to nearby tissue or lymph nodes. ATR kinase inhibitor VX-970 may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Giving ATR kinase inhibitor VX-970 together with cisplatin and radiation therapy may work     better in treating patients with locally advanced HPV-negative head and neck squamous cell     carcinoma.   "
54871|NCT02567409|"     This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with     or without ATR kinase inhibitor VX-970 works in treating patients with urothelial cancer that     has spread to other places in the body. Drugs used in chemotherapy, such as cisplatin and     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading. ATR     kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work     better alone or with ATR kinase inhibitor VX-970 in treating patients with urothelial cancer.   "
54872|NCT02567396|"     This phase I trial studies the side effects and best dose of talazoparib in treating patients     with solid tumors that have spread to other places in the body and usually cannot be cured or     controlled with treatment (advanced) or have spread to other places in the body (metastatic)     and cannot be removed by surgery and liver or kidney dysfunction. Talazoparib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
54873|NCT02567383|"     Clinical experience of with hyperthermia combined with radiotherapy and chemotherapy for     recurrent head and neck cancer is limited. The primary goals of hyperthermia combined with     CCRT on recurrent head and neck cancer are tumor response rate, while secondary goals are     rates of acute and late adverse effects, local control rate, distant metastasis rate,     progression-free rate and overall survival rate.   "
54874|NCT02567370|"     The purpose of this study is to find out the time it takes to absorb, distribute, breakdown     and remove the drug from the body, safety and tolerability of AMG 581 in healthy participants     and subjects with schizophrenia.   "
54875|NCT02567357|"     'PREDICTORS' (Parents Resources for Decreasing the Incidence of Change Triggered Temper     Outbursts) aims to evaluate web-based training packages for caregivers of children who show     frequent temper outbursts following changes to their routines and plans. The training     packages will teach caregivers how to apply strategies that aim to reduce the number of     temper outbursts that the children show following changes, as well as making any outbursts     they do show less severe (less functionally impairing).   "
54876|NCT02567344|"     This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking     Cannabis use disordered participants. Participants will then undergo either active, or sham     rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.   "
54877|NCT02567331|"     This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in     patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12     months, and the target sample size is 28 individuals.   "
54881|NCT02567279|"     The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal     factors that regulate the activity of bone cells. This alteration of bone remodeling is     characterized by increased bone resorption and decreased bone formation, leading to a marked     reduction of bone mineral density, osteoporosis and an increased risk of fracture.      To date, there is a paucity of studies and no consensus on the management of bone loss in     patients with AN. The few previous studies were performed with small samples and using short     follow-up periods.      Denosumab is a fully human monoclonal antibody that binds with high specificity to human     RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore     decreasing bone resorption that was found increased in patients AN.      Denosumab may transiently protect bone whilst psychonutritional management will induce a     weight restoration   "
54882|NCT02567266|"     Emotional disorders, including an array of anxiety and depressive syndromes, are the most     common psychiatric disorders among adolescents, are highly comorbid, and severely impair the     lives of youth and their families. Extant evidence-based therapies target only single     disorders or symptom domains, are often not adopted by community mental health center (CMHC)     clinicians, and have only modest effect sizes. To improve the clinical outcomes of these     youth, the proposed study tests the effectiveness of two novel interventions (a     transdiagnostic intervention, the Unified Protocol for the Treatment of Emotional Disorders     in Adolescents, and a measurement and feedback system, the Youth Outcomes Questionnaires)     relative to usual care in CMHCs.   "
54883|NCT02567253|"     The OvIP1 study is designed to examine how drug dose and perfusion temperature affect the     pharmacokinetics and pharmacodynamics of cisplatin used as (hyperthermic) intraperitoneal     chemoperfusion, as an adjunct to surgery, in women with stage III epithelial ovarian cancer.   "
54884|NCT02567240|"     The goal of this study is to determine whether harvesting islets using carbon monoxide     (CO)-saturated mediums can protect islet cell from death after autologous islet     transplantation in patients with chronic pancreatitis.   "
54885|NCT02567227|"     The investigators propose to conduct a single-blind randomized clinical trial to test the     efficacy of a computerized cognitive remediation intervention program on improving locomotion     in sedentary seniors, a group at an especially high risk for disability. The hypothesis is     that executive functions will respond to the cognitive remediation program and in turn     enhance locomotion.   "
54886|NCT02567214|"     The investigators will compare the reduction in Borg dyspnea score during the 3-min constant     rate shuttle walking test after 3 weeks of indacaterol 110 µg/Glycopyrronium 50 µg (Ultibro®)     versus Tiotropium 18 µg (Spiriva®) alone in patients with moderate to severe COPD.   "
55976|NCT02552927|"     Infants will be randomized to either chest shielding with aluminum foil or chest shielding     without aluminum foil while undergoing phototherapy for premature infants. The primary     outcome is patent ductus arteriosus.   "
54889|NCT02567175|"     FDA currently allows patients 12 years of age and older with various gastrointestinal (GI)     conditions to be treated with Domperidone through the Expanded Access to Investigational     Drugs program. These conditions include gastroesophageal reflux disease with upper GI     symptoms, gastroparesis, and chronic constipation. Patients must have failed standard     therapies to be eligible to receive Domperidone. This program facilitates availability of     investigational drugs, (such as Domperidone) to patients with serious diseases or conditions     when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or     treat the patient's disease or condition.   "
54890|NCT02567162|"     The aim of this project is development of a comprehensive, prospective, multinational,     multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.   "
54891|NCT02567149|"     The primary objective is to determine whether intralesional cidofovir is effective at     bringing about the total or near-total resolution of warts that have already proven     recalcitrant to standard therapy.      The secondary objective is to determine the tolerability of this new mode of administration     of cidofovir in the pediatric population   "
54892|NCT02567136|"     The purpose of the study is to determine if we are able to find one or more biomarkers of     Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic     resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker     is a measurable characteristic that can be used as an indicator of a particular disease     state. Identifying biomarkers of a disease can lead to a better understanding of the disease     as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy     controls.   "
54893|NCT02567123|"     The purpose of this study is to determine whether changing foot strike pattern from a     rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is     believed that switching foot strike pattern from a rearfoot strike to a forefoot strike     pattern will reduce associated running-related patellofemoral knee pain.   "
54894|NCT02567110|"     The purpose of this study is to determine the impact of inflammation on central nervous     system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in     middle-aged patients with major depression. Depression is associated with significant     alterations in glutamate concentrations and white matter integrity, which has been associated     with decreased antidepressant response, poor functional outcome, and cognitive impairment.   "
55120|NCT02564146|"     ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II     trial with two arms.      To estimate the treatment effect on overall survival, feasibility, efficacy and safety of     alternating treatment cycles of gemcitabine monotherapy followed by     nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles     in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles     of induction therapy with standard nab-paclitaxel/gemcitabine.   "
54895|NCT02567097|"     Tobacco use is the greatest cause of ill health and early mortality, and smoking is the main     contributor to around 75,000 deaths a year in England. The aim of the present research is to     test the effect of helping people to reward themselves when they have successfully abstained     from smoking and the impact this will have on subsequent smoking cessation. Each participant     will be randomly allocated to one of four conditions. The trial requires 159 participants to     perform an fully powered statistical analysis. The four conditions include: (1) a control     condition (asked to form a plan to quit smoking), (2) an implementation intention condition     (asked to form a more specific 'if-then' plan), (3) baseline which include: (1) a control     condition (asked to form a plan to quit smoking), (2) a volitional help sheet condition     (asked to link temptations with appropriate behavioural responses), (3) a weekly     self-incentivising condition (asked to reward themselves at the end of each week that they     have successfully abstained from smoking), or (4) a monthly self-incentivising condition     (asked to reward themselves at the end of each month that they have successfully abstained     from smoking). The main outcome measure will be smoking quit status, which will be verified     biochemically at the end of the stop smoking programme, and at six-months post quit date.   "
54896|NCT02567084|"     The purpose of this study is to assess the ability a injectable bi-phasic ceramic bone     substitute to provide bone generation and bone remodeling in patients with benign bone     tumors.   "
54897|NCT02567071|"     The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the     1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some     hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%.     The use of C-section continues to grow in every countries of the world despite that current     knowledge leads us to think that the vaginal birth, retained through millennia during     mammalian evolution, guarantees the implementation of the best suited intestinal microbiota     to build immunity and beneficial protective functions under the balanced mutual association     between the host and its microbiota. Oral administration of a previously impregnated swab, by     vaginal and maternal perineal secretions, following birth by planned C-section, would restore     the normal development of the newborn intestinal microbiota mimicking exposure to these     secretions during vaginal delivery.      The expected benefit is the establishment of a rich and diverse microbiota in individuals in     the intervention group and by extension improving the overall health of these individuals.   "
54898|NCT02567058|"     Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common.     Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and     that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical     properties are directly related to the tendon of the health status and its elongation     capacity.      The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive     ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the     viscoelastic properties of the tendon during the contraction of the sural triceps.      This is what we want to do in this first protocol: in vivo observation of the normal values     and variations, looking for changes related to hyper solicitation and finally trying to     highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon     rupture.   "
55430|NCT02560220|"     A phase- I clinical trial to determine safety and feasibilty of intravenous administration of     mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney     disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or < 15 mL/min) who receive a kidney     transplant from a living donor.   "
54900|NCT02567032|"     In this study, investigators will examine the behavioral effects and neurophysiological     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset     schizophrenia. Such research is a necessary first step towards identifying whether intranasal     oxytocin administration can serve as an adjunct treatment for social impairments in     schizophrenia.      Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in     patients with recent-onset schizophrenia.      Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition     (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved     in emotional or sarcastic communication) after administration of oxytocin versus placebo.      Hypothesis B: Patients and healthy comparison subjects will show increased attention to     others' eyes and patients will exhibit increased facial affect expressivity after     administration of oxytocin versus placebo.      Aim 2: To examine the effects of exogenous oxytocin on PNS activity in patients with     recent-onset schizophrenia.      Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS     activity during social tasks after administration of oxytocin versus placebo.      Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social     cognition and behavior will be predicted by the degree to which oxytocin increases their PNS     activity.   "
54901|NCT02567019|"     Periodontal diseases are a group of diseases that affect 15% of the population and in the     absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by     strong inflammation and hyper-vascularization. Search in blood cells and inflammatory markers     attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be assessed     by qualitative and quantitative analysis of blood phagocytes, natural killer cells,     complement, proteins of inflammation and cytokines. Current data from the literature on this     subject give contradictory results and the comparison of studies are difficult because the     diversity of the populations studied, evaluated cells and the methods used. The aim of the     study was to evaluate the innate immunity of patients with periodontal disease and compare it     with a group of patients without periodontal disease.   "
54902|NCT02567006|"     This project plans to learn more about whether sending text messages to parents on their     mobile phones to remind them when their child is due for his or her next vaccination will     improve children getting vaccinated on time.   "
55130|NCT02564016|"     The goal of this study is to evaluate the effect of continuous postpartum epidural saline     infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery     following vaginal delivery.   "
54903|NCT02566993|"     Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus     cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as     treatment in patients with small-cell lung cancer (SCLC) who failed one prior     platinum-containing line to determine a difference in progression-free survival (PFS) by an     Independent Review Committee (IRC) between lurbinectedin (PM01183)/doxorubicin (DOX) and the     control arm (CAV) or topotecan and to analyze the median overall survival (OS) and mid- and     long-term overall survival (OS at 12, 18 and 24 months).   "
54904|NCT02566980|"     The goal of the study is to define and measure biological processes that contribute to the     underlying pathophysiologic process of peri-partum depression to be used for identifying     those at risk for developing it. This knowledge may also generate novel drug targets for     peripartum depression that may be applicable to other types of depression.   "
54905|NCT02566967|"     This study will evaluate the optimal dose of tofacitinib needed to achieve low disease     activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical     remission has been achieved, the structural benefit in reducing erosions, synovitis and bone     edema as measured by low field MRI will be determined at the same time period by the use of     the OMERACT/RAMRIS scoring system   "
54906|NCT02566954|"     The study will be in 3 parts: first one will be to address the key question of the lower limb     frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays     and foot morphology assessment. Indeed, a major issue in the management of lower limb     disorders is the ability to correctly assess abnormal development and decide on the most     adapted treatment option. In particular, the link between lower limb disorders and foot     morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in     children has been successfully assessed using low-dose biplanar X-rays.      Second part will be to assess the reproducibility of the 3dimensional reconstructions whether     they are made by a radiology technician, or by a so-called expert through collecting datas     from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or     lower limb X-Rays.      Last part will be to work on the recently developed weight-bearing foot 3D reconstruction     method for clinical use using the Parametric Personalized Modelling approach (PPM). This will     allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.   "
54907|NCT02566941|"     Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of     COPD (chronic obstructive pulmonary disease) patients (among others) to improve their     resistance to efforts in everyday life. In patients in intensive care, it seems to improve     strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical     illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation days,     with expected effects on the duration of hospitalization and the long-term functional     outcome. Although its use could sometimes be limited by the development of peripheral edema     and use of vasoconstrictors, the main advantage of this technique is the possibility of being     used very early, even in patients that require deep sedation . This is extremely important     given that the muscular atrophy process already starts 18h after the onset of invasive     ventilation and as signs of impaired nerve transmission are developed in one third of     patients at risk within 72 hours.      The purpose of the study is to assess the effects, in the short and medium term, of early     neuromuscular stimulation in patients who are at higher risk of developing a critical illness     polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.      This is a randomized controlled single-blind study comparing a group of patients submitted to     NMES early (up to 5 days after admission) versus a control group unstimulated.   "
55431|NCT02560207|"     This study evaluates target attainment after either intermittent intravenous bolus or     intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill     patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.   "
54908|NCT02566928|"     The overall goal of the project is to develop and evaluate a home-based intervention to     prevent re-infection and transmission of Community-Acquired Methicillin-resistant     Staphylococcus aureus (CA-MRSA) in patients presenting to primary care with skin or soft     tissue infections (SSTIs). Centers for Disease Control (CDC) CA-MRSA guidelines include     incision and drainage, antibiotic sensitivity testing and antibiogram-directed prescribing.     Re-infections are common, ranging from 16% to 43%, and present significant challenges to     clinicians, patients and their families. Several decolonization and decontamination     interventions have been shown to reduce Hospital-Acquired MRSA (HA-MRSA) re-infection and     transmission in intensive care units. Few studies examine the feasibility and effectiveness     of these infection prevention interventions into primary care settings, and none employ     Community Health Workers (CHWs) or promotoras to provide home visits for education and     interventions about decolonization and decontamination. This comparative effectiveness     research/patient centered outcomes research builds upon a highly stakeholder-engaged     community-academic research and learning collaborative, including practicing clinicians,     patients, clinical and laboratory researchers, and barbers/beauticians. Clinical Directors     Network (CDN), an established, NIH-recognized best practice Federally Qualified Health Center     (FQHC) Practice-based Research Network (PBRN), and The Rockefeller University propose to     address this question through the completion of four aims: (1) To evaluate the comparative     effectiveness of a CHW/Promotora-delivered home intervention (Experimental Group) as compared     to Usual Care (Control Group) on the primary patient-centered and clinical outcome (SSTI     recurrence rates) and secondary patient-centered and clinical outcomes (pain, depression,     quality of life, care satisfaction) using a two-arm randomized controlled trial (RCT). (2) To     understand the patient-level factors (CA-MRSA infection prevention knowledge, self-efficacy,     decision-making autonomy, prevention behaviors/adherence) and environmental-level factors     (household surface contamination, household member colonization, transmission to household     members) that are associated with differences in SSTI recurrence rates. (3) To understand     interactions of the intervention with bacterial genotypic and phenotypic variables on     decontamination, decolonization, SSTI recurrence, and household transmission. (4) To explore     the evolution of stakeholder engagement and interactions among patients and other community     stakeholders with practicing community-based clinicians and academic laboratory and clinical     investigators over the duration of the study period.   "
54909|NCT02566915|"     The purpose of this study is to evaluate the effects of the application of Expiratory     Positive Airway Pressure (EPAP) on Dynamic Hyperinflation, dyspnea and exercise tolerance in     patients with Chronic Obstructive Pulmonary Disease (COPD).   "
54910|NCT02566902|"     This is a blinded observer randomized controlled trial comparing two nebulizer devices. The     objective of this study is to evaluate the efficacy of two different nebulizers.   "
54911|NCT02566889|"     The purpose of this study is to evaluate whether trough serum infliximab concentrations at     the time of loss of clinical response will identify pediatric participants with inflammatory     bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above     the currently approved dose [5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)].   "
54932|NCT02566616|"     Cubital tunnel syndrome is caused by compression of the ulnar nerve at the elbow. This leads     to symptoms such as chronic hand weakness, numbness and pain. This is usually treated with a     surgical procedure where the nerve is decompressed. Research has shown that nerve simulators     speed up the recovery of nerves following injury. The purpose of our research is to examine     the difference in patient outcomes after the nerve decompression surgery with and without     nerve stimulation.      Our research questions is: What are the differences in long term functional outcomes of     patients that have ulnar nerve decompression surgery with and without nerve stimulation?   "
54912|NCT02566876|"     Abdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly     Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and     no safe and effective treatment is available. Although probiotics have shown promising     results in adults, few studies have been published in children. The Bifidobacterium Infantis,     Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial bacteria     in children and represent 95% of the total bacterial population in the intestine of breastfed     infant.      Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria     on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To     evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life     in children with FD and IBS.   "
54913|NCT02566863|"     Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart     rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic     vascular resistance increases. The indication for the drug is to produce sedation during     surgical procedures and in ICU patients.      The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure     and heart rate variability during drug infusion) depend on pre-drug autonomic system     activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement     before drug injection and during drug infusion. Heart rate and blood pressure measured before     and during drug infusion will be analysed.      HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug     injection and during its infusion. 5 minutes intervals will be analysed , using Frequency     Domain Measures of HRV. Surgical procedure will start after measurement have been taken.   "
54914|NCT02566850|"     The purpose of the study is to study the safety and health effects of using the Ekso Bionics     powered exoskeleton device in a home setting over a 12-36 month period.   "
54915|NCT02566837|"     Intramuscular injections of botulinum toxin are currently the best focal treatment of     spasticity, with clearly defined indications and role. French and European recommendations     focus on the toxin's mode of administration, which must be as precise as possible. The     toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the     importance of targeted injections within the muscle belly. The pain caused by these     injections is due partly the number of injections (up to 30 in a single session), and partly     to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused     by these injections have become a regulatory obligation since the law of 4 March 2002     relating to the rights of patients and the quality of the health system ( Any person has the     right to receive relief from pain, which must, under all circumstances, be prevented,     evaluated, taken into account and treated … ).   "
54923|NCT02566733|"     Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is     performed using the Minto model. It was derived from patients undergoing general surgery.     However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The     investigators tested whether Minto model for target controlled infusion produces constant     plasma remifentanil concentration during the cardiac surgery.   "
54974|NCT02566070|"     This multi-center, prospective, randomized comparative effectiveness intervention study will     evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect     on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated     critically ill children for up through 24 hours post achievement goal feeds or exclusion from     feeding protocol, whichever comes first, to a maximum of 10 days.   "
54916|NCT02566824|"     Attention Deficit/ Hyperactivity Disorder (ADHD) is a common childhood psychiatric condition,     which often persists into adolescence. In adolescence ADHD is associated with poor academic,     social, and emotional functioning, other psychiatric problems, substance abuse, and     antisocial behaviour. Although medication effectively reduces symptoms such as hyperactivity     and inattention, it does not directly address academic, social, emotional, and behavioural     problems. Overcoming these would require building skills in organization, time management,     problem solving, emotional modulation, stress management and interpersonal rapport. Yet,     psychosocial treatments targeting such skills in adolescents with ADHD have been little     studied and are scarce in the community. The proposed study will evaluate cognitive     behavioural and skills training therapy (CBT+S) for medicated adolescents with ADHD.     Adolescents will be stabilized on optimized medication and randomly assigned to 14 sessions     of either manualized group CBT+S or manualized supportive group therapy (SGT). An additional     treatment-as-usual group will also be included. CBT+S will focus on skill acquisition in     common problem areas for adolescents with ADHD, such as organization and time management,     distractibility, impulsivity, and social skills. A coach will call each participant twice a     week to help practice the learned skills.      Parallel groups will be provided for parents of CBT+S and SGT participants focusing on     education, support and sharing experiences. If CBT+S proves to benefit adolescents with ADHD,     it can be made widely available to these adolescents in the community. This would help them     improve their academic, social, and emotional functioning and ultimately their long term     outcomes.   "
54917|NCT02566811|"     The primary aim of this trial is to determine whether lymphadenectomy, used to restrict     adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a     non-inferior survival as compared to adjuvant therapy given to all women with high risk     apparent stage 1 endometrial cancer.   "
54918|NCT02566798|"     Osteoarthritis is a degenerative disease that affects a growing proportion of the population.     There is currently no treatment to halt this process. The aim of the research is in     particular to find treatments targeting the molecular origins of osteoarthritis focusing     especially on the inflammatory component of the disease. That is why research is looking to     the development of preventive treatments like nutraceuticals. This project aims to determine     the anti-inflammatory properties of sera of patients who received supplementation of their     diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be     collected during visits for hyaluronic acid injections in OA patients. These sera will be     tested in vitro in a model of inflamed chondrocytes.   "
54933|NCT02566603|"     Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may     lead to improved platelet levels where these are decreased due to immunological pathologies     and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been     shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The primary     objective of the study is to assess the efficacy of PRTX-100 in terms of platelet response in     patients with chronic/persistent ITP.   "
54997|NCT02565771|"     Survival rate of childhood cancers is now reaching 80%. However, early or late complications     related to surgery, chemotherapy and radiotherapy remain high and greatly increase the risk     of late mortality.      Health of individuals is closely correlated to the stability of the autonomic nervous system     (ANS), a key system for maintaining homeostasis in any living species. Efficient computer     tools allowed the opportunity to assess the intrinsic autonomic regulation of the ANS either     directly or at a later time by an analysis of the heart rate variability (HRV). These tools     have become very powerful predictors of cardiovascular morbidity and neurological aging.     Physical endurance training improves both maximal aerobic capacity and ANS activity.   "
54919|NCT02566785|"     Purpose: The purpose of this pilot study is to evaluate the effect of a multi-component     balance & resistance training [RT] intervention on physical function, balance, & falls in     older [≥ 65 y/o] community dwelling heart failure [HF] patients. The study aims: 1] Pilot     test multi-component balance activities & RT intervention on primary outcomes. 2] Explore     perceptions related to outcomes & the intervention through focus groups. 3] Generate pilot     data on adherence. 4] Generate pilot data on feasibility of conducting the BASIC Training     intervention.      Background/Significance: Falls are the leading cause of injury-related deaths in this group.     Fall risks are even greater for those with HF due to decreased exercise capacity, loss of     skeletal muscle & medication side effects. Though RT is effective for improving skeletal     muscle, it has only a modest effect on improving balance, which is comprised of peripheral     sensory input central integration, & motor output. A multi-component intervention focusing on     balance retraining & strengthening the muscles supporting static/dynamic balance & functional     mobility is necessary.      Methods: Design - Randomized, two-group with wait list control, repeated measures     experimental design. Sample/ Setting - 40-50 participants recruited from medical center heart     failure clinic; supervised group sessions conducted in center's health & wellness center.     Procedures - Participants will be randomized to intervention group or wait list control     group. Focus groups pre/post intervention. The intervention will be administered in 1x per     week supervised group sessions & 2x a week home sessions. Instruments - 30 Second Sit-to-St&,     Modified Clinical Test of Sensory Interaction on Balance, Activity Specific Balance     Confidence Scale, Timed Up & Go, Dynamic Gait Index.      Analysis Plan: Aim 1- independent t-test to compare change scores from baseline to the end of     the first 12 week period for the intervention group with the wait list control group. A     second analysis will combine data from the delayed intervention period for the wait list     control group with that from the first 12 week period for the intervention group to test     change. Supplemental analysis, involving only data from intervention group, will test whether     change is sustained at 24 weeks. Aim 2 - thematic analysis conducted with focus group data.     Aim 3 - adherence assessed by group session attendance & home activities completed. Aim 4 -     assess & report logistics of conducting the study.      Nursing Relevance/Implications: This pilot study will initiate the process of developing a     targeted intervention to induce changes in elderly HF patients to prevent future falls; thus     reducing costs, physical & emotional burdens related to falls; & effect a major difference in     the quality of life for this population.   "
54920|NCT02566772|"     The purpose of this trial is to investigate the safety and tolerability of TAS3681 and to     find the maximum tolerated dose of TAS3681.   "
54921|NCT02566759|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK)     of single and multiple rising doses of TAK-831 in healthy participants.   "
54922|NCT02566746|"     The investigators' study aims to compare the results of percutaneous endoscopic caecostomie     (CPE) to optimal medical therapy in the treatment of patients with constipation refractory to     medical treatment. The primary endpoint will be the quality of life assessed by the     Gastrointestinal Quality Of Life Index (GIQLI) at one year. The secondary endpoints are     digestive symptoms, Kess's constipation scores and Cleveland's incontinence score, tolerance     of the Chait TrapdoorTM caecostomy catheter (CTCC) and the collection of possible     complications. The patients included must meet the classification criteria of Rome III, have     an elongated colonic transit time, have had a complete colonoscopy and be refractory to     medical treatment including at least one stimulant laxative or suppositories or enemas     retrograde.   "
54924|NCT02566720|"     This is a pilot study. The objective is to further understand the mechanism by which     amantadine improves function in patients with persistent vegetative state and minimally     conscious state. Specifically, the investigators will measure the size of the nerve fibers     that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI     tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score.     The information gathered from this study will be used to formulate a larger clinical trial.   "
54925|NCT02566707|"     During the past years the treatment of HIV-1 infection has transformed towards chronic     treatment. Patients are being treated with antiretroviral drugs for many years and become     older. The risk of developing side-effects due to long term antiretroviral therapy is     therefore more and more likely. New alternative once-daily maintenance regimes are needed for     those who are extensively pre-treated and experience side-effects or toxicity on standard     treatment combinations. A possible once-daily, fully active maintenance regimen is the     combination of atazanavir (unboosted), dolutegravir and lamivudine (PRADAII regimen). This     combination is expected to be a safe, once-daily maintenance regimen with a favorable     side-effect profile. The combination suits patients with intolerance and/or resistance to     NRTIs, NNRTIs and ritonavir, who have a suppressed viral load. However, for this new     combination the pharmacokinetic profile is unknown and there are no data on short-term and     long-term safety and efficacy. This study wille therefore asses the pharmacokinetics, safety     and efficacy in a small number of HIV-1 infected patients.   "
54926|NCT02566694|"     The investigators aim to determine the cause of failure of orthopaedic implants using     multi-disciplinary analysis of data from patients who have undergone revision.   "
54927|NCT02566681|"     The purpose of this study is to evaluate the safety of use of autologous bone marrow stem     cells seeded on porous tricalcium phosphate matrix and demineralized bone matrix in patients     with osteonecrosis of the jaw by a prospective, single-center, open, nonrandomized and     unblinded clinical trial.   "
54928|NCT02566668|"     This research study is being done to learn more about severe asthma by comparing people with     severe asthma to those with milder forms of asthma and people without asthma, at baseline and     over time. Individuals are being asked to join a research study to help understand the     differences in the lungs and blood of participants with severe asthma compared to those with     milder asthma and healthy individuals, as well as differences in overall health.     Investigators also want to determine whether these differences predict asthma-related and     biologic outcomes over 1 year of follow up.   "
54929|NCT02566655|"     The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated     autologous bone marrow cells as a new therapy in patients with established osteoporosis by a     prospective, single-center, open, non-randomized and unblinded clinical trial.   "
54930|NCT02566642|"     When presenting for elective surgery, patient's often do not completely understand the role     that the anesthesiology team plays in their care. In 1999, the American Medical Association     (AMA) found that health literacy was a stronger predictor of a person's health than age,     income, education level and race. It is very important that the investigators provide     information to patients on the role of anesthesiologists in their care before, during, and     after the surgery as it has been shown to improve patient anxiety and overall satisfaction.   "
54931|NCT02566629|"     Analyze microbiota community of irritable bowel syndrome in episodes phase and remission     phase.   "
54934|NCT02566590|"     One third of independent older adults over the age of 65y will be hospitalized for an acute     medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults     will experience functional decline during their hospital stay from the amount of time they     are physically inactive and in bed. Following discharge, the functional deficits can persist     for months and in many instances never return to pre-hospitalization levels thus compounding     morbidity, health care costs and dying. A classic consequence of short-term bed rest in older     adults is the significant loss in skeletal muscle mass which underlies the accelerated leg     strength deficits. The investigator has shown that an important mechanism of skeletal muscle     loss is the inability of nutrients to stimulate a normal muscle protein synthesis response; a     process highly regulated by the mammalian target of rapamycin signaling pathway (mTOR) and     amino acid transporters. Day to day maintenance of force generating muscle tissue is dictated     by anabolic stimulation from muscle contraction and essential amino acid ingestion.     Therefore, anabolic interventions such as neuromuscular electrical stimulation (NMES) and     high quality protein supplementation that contains a high proportion of essential amino acids     (whey protein) may be promising approach to maintain leg muscle mass and strength in     hospitalized older adults and prevent the long term consequences of repeated periods of     short-term physical inactivity. The purpose of this study is to test in older adults if the     combination of NMES and protein supplementation is capable of preserving muscle mass and     strength and maintaining muscle nutrient anabolic sensitivity during bed rest. The     investigators current hypotheses are that daily NMES and protein supplementation during     5-days of bed rest in older adults will: 1) preserve lower extremity muscle mass and strength     and 2) maintain muscle nutrient anabolic sensitivity as measured by mTOR signaling and amino     acid transporter expression. The long term goal is to utilize this inpatient preventative     therapeutic approach in a clinical setting in which muscle mass and strength deficits are     profound (e.g., intensive care patients).   "
54935|NCT02566577|"     The purpose of this study is to determine how red blood cell transfusions, particularly the     length of storage time of units of packed red blood cells, affects the cardiovascular     function in patients receiving transfusions. This study will also determine the most ideal     way of storing and processing blood, and assess how transfusion affects a person's ability to     exercise and how their blood vessels relax and contract.   "
54936|NCT02566564|"     Phase I/IIa study to determine the safety and clinical effects of intra-articular injections     of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.   "
54937|NCT02566551|"     The purpose of this prospective randomized controlled study is to compare the improvement of     symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients     undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the     prostate (TURP).   "
54938|NCT02566538|"     Aging is a long term process, starting early in life, and progressively affecting various     functions and organs. Cardiovascular diseases and cognitive impairment are two conditions     related to advancing age and sharing common risk factors. The Mona Lisa- PREDOR study is a     population-based prospective cohort study carried out to develop risk prediction algorithms     aimed at identifying people who are the most likely to develop impaired psychometric and     cognitive functioning and impaired cardiovascular risk, in the coming years.   "
54939|NCT02566525|"     Prospective, multi-center, randomized, feasibility clinical study. Subjects will be     randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and     treatment with the CytoSorb® device.   "
72017|NCT02343094|"     The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2     urinary expression in proteinuric patients.   "
54940|NCT02566512|"     The investigators propose to assess cough strength in patients undergoing spontaneous     breathing trials in the Intermediate Intensive Care Unit (IICU) and compare their cough     strength under two conditions,        1. Tracheostomy cuff inflated: cough strength will be measured with the tracheostomy cuff          inflated and the patient coughing through the tracheostomy tube.        2. Tracheostomy cuff deflated: cough strength will be measured with the tracheostomy cuff          deflated and the patient coughing around the tracheostomy tube, through their mouth..      The investigators hypothesize that patients will have a stronger cough when they can use     their vocal cords.   "
54941|NCT02566499|"     The main goal of this project is to assess the ability of a recently developed Breast     Microwave Imaging (BMI) system to detect abnormalities in a human breast. These trials will     be performed by recruiting fourteen volunteers that have been diagnosed with breast     abnormalities using x-ray mammography. The breast presenting the abnormality will be imaged     using the BMI system in a controlled and comfortable environment. As this is a feasibility     study of the technology, and has the main goal to evaluate the diagnostic accuracy of this     technology. The data collected from this study will be used to: (1) evaluate the overall     participant experience during the BMI imaging procedure, (2) optimize the design of the BMI     imaging system (both hardware and software), (3) open discussions with other medical     professionals (e.g. radiologists) about the clinical feasibility of this emerging diagnostic     imaging modality.   "
54942|NCT02566486|"     Aim The aim of this clinical study was to evaluate the influence of the instrumentation     techniques on the incidence and intensity of postoperative pain in single-visit root canal     treatment.      Methodology Ninety patients with single root/canal and non-vital pulps were included. The     patients were assigned into 3 groups according to root canal instrumentation technique used;     the modified step-back (stainless-steel hand files, HF), reciprocal (WaveOne, WO), and     rotational (ProTaper Next, PTN). Root canal treatment was carried out in a single visit and     the severity of postoperative pain was assessed by 4-point pain intensity scale. All the     participants were called through phone at 12, 24 and 48 h to obtain the pain scores. Data     were analyzed by the Kruskal-Wallis test.   "
54943|NCT02566473|"     Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing     all regions of the country and varied hospital and surgeon practice settings (e.g.,     urban/rural, low and high volume) to ensure that registry analyses and research reflect     typical clinical practice thereby providing optimal guidance for patients, clinicians, and     national healthcare policymakers. Collect pre-operative and post-operative patient reported     outcomes (PROs) for pain and function.      Aim 2: Develop new and transformative comparative effectiveness tools useful to both clinical     practice and healthcare policy.      Aim 3. Broadly disseminate surveillance reports for adverse events, such as implant revision,     hip dislocation, knee manipulation, and identify important variation to inform quality     improvement priorities.   "
54956|NCT02566304|"     This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy     before donor stem cell transplant in treating patients with hematologic malignancies. Giving     low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor     stem cell transplant may help stop the growth of cancer cells. It may also stop the patient's     immune system from rejecting the donor's stem cells. The donated stem cells may replace the     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor     effect). Reducing the intensity of the chemotherapy and radiation may also reduce the side     effects of the donor stem cell transplant.   "
54944|NCT02566460|"     The purpose of this study is to explore and assess possible outcome benefits of lactate     clearance＞30% vs ScvO2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of during     early resuscitation of septic shock through a single-center randomized controlled study. The     investigators anticipate to collect 300-400 qualified patients with septic shock who were     selected from critically ill patients admitted to the Department of Critical Care Medicine.     The participants can be randomized divided into lactate clearance group and SCVO2 group. The     investigators compared the treatment and the relevant parameters changed after different     target. 28-day mortality, ICU and hospital lengths of stay, ventilator-free days, and new     emerged organ failure were collected and compared. 28-day survival curves were drew between     these two group. And the adverse events of the treatment have also been compared. Through     this study, the investigators want to answer that whether lactate clearance-oriented therapy     can reduce the mortality in patients with septic shock, compared with ScvO2-oriented     protocolised therapy.   "
54945|NCT02566447|"     The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for     the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the     Helicase-Dependent Amplification (HDA) technology and the Solana instrument.   "
54946|NCT02566434|"     Participants will receive four different doses of methionine through four month long     interventions with a two week wash-out period in between intervention. The dose will increase     with each intervention. Two visits during each intervention will also involve receiving     stable isotope infusion to determine the metabolism of methionine in the body. Participants     will also be monitored via blood work and questionnaires regarding overall health.   "
54947|NCT02566421|"     This pilot clinical trial studies patients' genomic sequencing in determining specific     treatments, also called Precision Medicine, in patients with cancer that has spread to other     parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic     code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid [DNA] sequence     of a cell or gene) may be identified and matched with available treatment that targets the     mutated gene or an alternative treatment that may provide benefit for the patient with the     mutation identified. Precision medicine may impacts patient's response to treatment by     targeting specific mutations and may increase survival and improve quality of life.   "
54970|NCT02566122|"     Normal values for muscle strength using hand held dynamometer and muscle mass using     echography are largely unknown. The objective of the present study is to establish normal     values of these measurements in population living in France.   "
54975|NCT02566057|"     This study evaluates whether prospective pharmacogenetic testing is cost-effective in     affecting clinical treatment outcomes in patients with early-phase psychosis.   "
72430|NCT02337686|"     The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to     control glioblastoma. The safety of this drug will also be studied.   "
54948|NCT02566408|"     This clinical trial studies the attitudes, beliefs, and preferences of older stage I-III     breast cancer survivors towards physical activity. Studies have shown that older     African-American and women of lower socioeconomic status are more likely than their Caucasian     counterparts and women of higher socioeconomic status to have functional disability at the     time of a new breast cancer diagnosis. Functional disability is the inability to     independently complete activities of daily living and increases health care costs and deaths.     The poor health status of older African-Americans with breast cancer has been suggested to     diminish the long-term benefits from cancer treatment, resulting in older African-American     women more likely to die from breast cancer compared to Caucasians. Questionnaires that     measure the attitudes, beliefs, and preferences of older breast cancer survivors may lead to     the development of an intervention that increases physical activity, improves functional and     health status, and improves breast cancer treatment benefits translating to improved survival     among older breast cancer survivors in general, and in particular among older     African-American and lower socioeconomic status women with breast cancer.   "
54949|NCT02566395|"     This clinical pilot trial is intended to evaluate the feasibility, efficacy and safety of     hematopoietic stem cell transplantation (HSCT) from Human Leukocyte Antigen (HLA)-mismatched     related donors for children and young adults with hematologic malignancies who lack a     suitably matched related or unrelated donor. The methodology will be one that has been     successfully utilized in adult patients at Thomas Jefferson University.   "
54950|NCT02566382|"     Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative     spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.   "
54952|NCT02566356|"     In this study, investigators will examine the behavioral effects and neurophysiological     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset     schizophrenia. Such research is a necessary first step towards identifying whether intranasal     oxytocin administration can serve as an adjunct treatment for social impairments in     schizophrenia.      Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as     measured by fMRI during a well-characterized affect-labeling task in patients with     recent-onset schizophrenia and healthy comparison subjects.      Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when     passively viewing faces, which will be normalized by administration of oxytocin.      Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces     and this hypo-activity will be normalized by oxytocin administration.   "
54953|NCT02566343|"     This prospective study intends to investigate the incidence of postoperative pulmonary     complications (PPC) or in-hospital mortality in patients with COPD or at risk for COPD     undergoing high-risk noncardiac major surgery and to identify relevant risk factors.     Furthermore, this study aims to quantify and compare the diagnostic performance of     preoperative functional tests, exercise capacity, clinical assessment tests and predictive     scoring systems to predict PPC or in-hospital mortality in these patients.   "
54954|NCT02566330|"     The aim in the current proposal is to evaluate the long-term outcome of the EndoBarrier     device. The group of participants the investigators want to study participated in earlier     studies at the Maastricht University Medical Center (MUMC) and the Atrium Medical Center in     Heerlen. Three years of follow-up after the EndoBarrier device is now available. The     investigators hope to give new insights in the postoperative status and postoperative     symptoms experienced by the study participants using standardised questionnaires and     evaluating blood samples. The goal of the investigators is to study the long-term effect of     the EndoBarrier procedure and to possibly provide insight in the relation between     success/failure and objective parameters.   "
54955|NCT02566317|"     A trial testing the efficacy of sit-stand workstations on decreasing sitting time and     increasing light-intensity physical activity in samples of office worksites.   "
54958|NCT02566278|"     The investigators hypothesis is that upper airway collapsibility (Pcrit) in patients with     obstructive sleep apnea (OSA) can be measured using equipment found in the clinical sleep     laboratory and these Pcrit measurements obtained using clinical sleep laboratory equipment is     comparable to those obtained using research equipment. OSA is a common disease characterized     by repetitive collapse of the upper airway during sleep, leading to hypoxemia and arousals,     and which has important neurocognitive and cardiovascular consequences. The single most     important factor in the development of OSA is upper airway collapsibility: those with a more     collapsible upper airway tend to have OSA while those with a stiffer upper airway do not. The     gold standard treatment for OSA is continuous positive airway pressure (CPAP), which acts by     stenting open the collapsible airway. Upper airway collapsibility can be measured during     sleep by changing the CPAP level and assessing the change in inspiratory flow through the     upper airway. Although technically feasible, these measurements are typically only undertaken     in research laboratories with specialized equipment. The purpose of this study is to measure     upper airway collapsibility using clinically available (i.e. equipment found in a clinical     sleep laboratory) equipment only. If successful, upper airway collapsibility could be     routinely measured in clinical practice, which could help inform treatment decisions and help     individualize therapy for OSA.   "
54959|NCT02566265|"     The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster     to all patients with monoclonal gammopathies (irrespective of age) will lead to     seroconversion rates exceeding 50% and more importantly, will reduce influenza-related     morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the     end of the flu season   "
54960|NCT02566252|"     This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol     sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.   "
54971|NCT02566109|"     The overall of this proposal is to test in community hospitals the utility of a 10-min     magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis     algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for     breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with     a time-efficient method to identify those at risk of a future CV event so that prevention can     be implemented to prolong survival and reduce morbidity in cancer survivors.   "
54972|NCT02566096|"     This study aims to compare the analgesic efficacy of transversus abdominis-plane block with     bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer     surgery.   "
54961|NCT02566239|"     The purpose of this study is to learn more about how to maintain health and independence for     seniors by developing tools that collect data constantly from their home. Caregivers can then     use this information to make decisions about their health care, such as when an individual     may not be able to live independently any longer. Specific Aims of this study are:        -  Aim 1: To identify trends in our data that predict health decline. To serve this aim, we          want to test a number of tools that we have developed, such as in-home sensors, to          determine which ones are best at measuring health risks in seniors. After collecting          information for one year, we will look at which tools could be most useful to provide          feedback to seniors and their communities about the process of aging.        -  Aim 2: To develop a system for analyzing the data we collect and presenting a summary of          the data to care teams.        -  Aim 3: To validate our data and the computer-based tool in senior community settings.   "
54962|NCT02566226|"     Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed     under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the     patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic     episodes is unknown. The objective of this randomised controlled trial is to investigate the     effect of intrathecal morphine and surgery on apneic episodes.   "
54963|NCT02566213|"     The human performance during weightlessness was tested in a multiplicity of laboratory     experiments during parabolic flights and in space. It is therefore known that human fine     motor skills as grasping are affected by the impact of changing gravity levels. However,     because everyday life movements differ in several aspects from those done in an experimental     lab situation, investigators do not know until know if this kind of movements is altered in     the same extend.      Fine motor skills seem to depend on the context in which they are made. Thus, the performance     in weightlessness during everyday life could substantially differ from the results given by     previous laboratory studies.      This assumption will be tested in the present project, with subjects executing one and the     same grasping movement in two different contexts, both in normal gravity conditions and in     weightlessness. To that end, the investigators developed a new method which allows comparing     the same grasping movements under different conditions.   "
54964|NCT02566200|"     Over the last two decades, considerable progress has been made in the management of     myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase.     However changing practices in the real world and their impact on prognosis in the medium     and long term patients admitted to the intensive care unit for acute myocardial infarction     are relatively little studied exhaustively.      The study of clinical, biological and genetic characteristics of patients and their     conditions of care, help to identify patients at risk for increased morbidity and mortality     after myocardial infarction and could be the basis for the subsequent realization of specific     studies on the optimal therapeutic management of the disease according to the different risk     profiles.   "
54965|NCT02566187|"     A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the     Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of     Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.   "
54966|NCT02566174|"     Background:      Cancer causes changes in the lives of patients and in the lives of their caregivers. Patients     and caregivers feel stress and they affect each other as they deal with these changes. They     each cope with cancer diagnosis and treatment on their own. They also cope together.     Researchers want to explore this shared change of roles and responsibilities. They will do     this by gaining insight into the social experience of cancer caregiving. They also want to     better understand the ways caregiver/patient teams manage the cancer diagnosis and     experience. This can help find new ways to support caregivers and their patients.      Objective:      To explore the shared change of roles and responsibilities of patients and caregivers by     studying the social experience of cancer caregiving.      Eligibility:      English speakers ages 18 and older who are one of the following:      A cancer patients at the NIH Clinical Center (CC)      A caregiver of a CC cancer patient      Design:      Participants will have been screened by the CC.      Patients and caregivers will be interviewed separately. This will last up to an hour and a     half.      Participants will complete online surveys.      Participants may have a follow-up phone interview. This will last up to 15 minutes.   "
54967|NCT02566161|"     Data on transgenerational effects following nuclear accidents are important for understanding     fully the consequences of parental exposure to ionizing radiation. Few studies to date have     had adequate statistical power to detect effects of the magnitude expected based on animal     data, and most have not been of low-dose, protracted exposures associated with nuclear     accidents and their aftermath. Although, to date, scant use has been made of the new genomic     technologies, in Chernobyl-exposed areas of Ukraine and Belarus, excess minisatellite     mutations have been seen in children born after the accident. We propose a study of     parent-child trios in which at least one parent was exposed to Chernobyl radiation as a     clean-up worker (mean dose >=100 mGy) and/or evacuee from a contaminated area (mean >=     50mGy). The specific aims are to investigate the transgenerational and de novo mutation rates     of the spectrum of genetic variants in trios, in particular looking at effects in children     and mapping them to possible parental origin of the chromsome. Together with long-term     collaborators at the Research Center for Radiation Medicine (RCRM) in Kiev, epidemiologic     data will be collected for up to 450 trios of parents with preconceptional doses and their     unexposed offspring. We will use state-of-the-art genomic technologies to characterize the     landscape of the genomes of the trios to determine whether parental radiation exposure is     associated with genetic mutations transmitted to the offspring, by examining de novo mutation     rates, minisatellite mutations, copy number alterations, and variations in telomere length.     The analysis will be conducted in peripheral blood and/or buccal samples (when blood is not     available) from complete father-mother-child trios. Doses to the gonads from the time of the     accident to the time of conception will be reconstructed for all parents using existing     records supplemented by interview data.      Trio subjects will be selected from representative populations exposed to radiation from     Chernobyl who are under active follow-up in the Clinico-Epidemiologic Registry at RCRM. To     help identify specific effects of paternal and maternal radiation exposure, we will initially     select sets of trio subjects in five categories: (1) exposed father, unexposed mother; (2)     unexposed father, exposed mother; (3) both parents exposed; (4) both parents unexposed; and     (5) a group of high dose emergency workers with acute radiation syndrome. All trio members     will be invited to the RCRM outpatient clinic for collection of a 20 ml blood sample (or     buccal cells for those who refuse phlebotomy). Both parents will be asked to complete a     general questionnaire to obtain demographic and lifestyle data. Then one or both will     complete detailed dosimetry questionnaires, based on forms used in previous collaborations     with RCRM and administered by specially trained interviewers. Once 50 trios have been     recruited (10 from each of the 5 exposure categories), we will conduct an interim evaluation     of participation rates, sample collection and quality, and dose reconstruction in order to     modify the protocol as needed. The analytical approach will be to correlate the extent,     especially for de novo events of genetic alterations in the offspring with parental     preconceptional radiation dose overall and by parental origin. The statistical power in     relation to de novo mutations is very high, in excess of 90%, but somewhat lower for trends     in minisatellite mutations. Study findings will contribute importantly to knowledge of the     heritable effects of moderate- and low-dose radiation exposure in humans and to radiation     risk projection. Eventually data from the Trio Study may be shared with the international     community through dbGap.   "
55160|NCT02563626|"     International registry gathering patients with angiographically confirmed coronary aneurysm.   "
54968|NCT02566148|"     Populations from Sub-Saharan Africa represent one of the most dynamic immigration flows in     France and are among the most exposed to HIV infection and hepatitis B.      The Parcours study aims to understand, among sub-Saharan African migrants, how social and     individual factors combine in the course of migration and settlement in France, and influence     the risk of infection, access to prevention and care, and the effectiveness of care for both     HIV and hepatitis B diseases.      The research was conducted in Ile-de-France, where 60% of sub-Saharan African migrants     reside. It consists in a cross-sectional observational survey, using a life-event history     approach that reproduces the sequence of different life and health events, and contributes to     explain the present situation (type of disease management, patient's quality of life) in     light of all the elements of the past trajectory (administrative, familial, socio-economic,     professionals).      A representative survey was conducted between February 2012 and May 2013 in health care     facilities in Ile-de-France, among three groups of migrants from Sub-Saharan Africa: a group     living with HIV, a group living with chronic hepatitis B and a group who has neither of these     diseases. For each group, stratified random sampling was used. The survey was conducted in 24     hospital services providing HIV care, 20 health care facilities providing hepatitis B care,     and 30 primary health care facilities.      Were eligible all patients attending these health care facilities, born in a Sub-Saharan     African country and with Sub-Saharan African citizenship at birth, aged 18 to 59 years, with     an HIV diagnosis (HIV group) or chronic hepatitis B diagnosis (hepatitis B group) more than     three months prior or not diagnosed with HIV or chronic Hepatitis B (reference group).      Among the patients offered participation, 926 HIV-infected patients, 779 patients infected by     hepatitis B, and 763 patients without these two diseases participated in the study.      For all participants, detailed information on socio-demographic characteristics; migration     and life conditions in France; social, sexual and reproductive life history; and screening     and care history were collected using a life-event history questionnaire administered     face-to-face by a specialized interviewer. Health care professionals documented clinical     information from the medical records. Data was collected anonymously.   "
54969|NCT02566135|"     Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have     been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia     with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation     may become difficult sometimes and endangers patients life. Using SGAs as a conduit for     tracheal intubation helps in securing airway. This will be further facilitated by using     ventilating bougie, as it maintains oxygenation.   "
54973|NCT02566083|"     Post-approval study to evaluate the rates of visual distortions for patients requiring >2.0 D     of corneal astigmatism correction   "
54976|NCT02566044|"     This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top     of standard of care. The study will be divided into 3 Cohorts. Cohorts 1 and 2 are designed     to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to     assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled QBW276     over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis regardless of     their genotype.      In contrast, cohort 3 is a randomized, double-blind, placebo-controlled, cross-over design,     multiple dose study to assess the efficacy, safety, tolerability and pharmacokinetics of     inhaled QBW276 over 4 weeks in patients with cystic fibrosis who are homozygous for the     F508del mutation.   "
54977|NCT02566031|"     To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once     daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15     min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients   "
54978|NCT02566018|"     This study is set to evaluate a proposed standard for the treatment of proximal humerus     fractures   "
54979|NCT02566005|"     A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital     labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb     together with vaginal misoprostol will result in shorter induction to delivery time compared     with vaginal misoprostol alone   "
54980|NCT02565992|"     This study will employ a phase Ib design using the established dose of CAVATAK with     pembrolizumab in subjects with advanced melanoma for whom pembrolizumab would be considered     standard of care. Our hypothesis is that oncolysis of melanoma cells by CAVATAK will be     important in amplifying the T-cell potentiating effects of pembrolizumab.   "
54981|NCT02565979|"     The main objective of the study is to investigate if 6 months resveratrol supplementation can     improve glucose tolerance in overweight/obese individuals. As secondary objectives we want to     investigate whether resting energy metabolism, intra-hepatic lipid content, physical     performance, body composition and quality of life change by 6 months resveratrol     supplementation in these individuals.   "
54998|NCT02565758|"     This is an open-label dose escalation study designed to evaluate the safety and     pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in     combination with standard therapies) in subjects with advanced solid tumors.   "
54999|NCT02565745|"     Study purpose:      To assess if - in adult patients admitted to hospital with surgical or medical conditions at     high/very high risk of developing pressure ulcers (PU) according to Braden scale - using skin     dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the     incidence of in-hospital PU   "
55000|NCT02565732|"     This is a safety and efficacy study of botulinum toxin type A in subjects with primary     axillary hyperhidrosis.   "
54982|NCT02565966|"     The purpose of this study is to better define the potential molecular and anti-inflammatory     changes induced by the modified Atkins diet in the brains of patients with treatment     resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to     compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20     subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks     prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher     carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects     in this study to compare serologic and brain tissue specimens. Approximately five (5)     subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5)     subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue     specimens will be obtained at the time of surgery and will be compared. The goal of this     study is to identify whether or not there are changes in neuroinflammation or     neuroexcitability in the human brain induced by the modified Atkins diet.   "
54983|NCT02565953|"     In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA)     balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal     arteries. This device combined the mechanical action of PTA balloon with the     antiproliferative effects of paclitaxel. The use of these devices in venous pathology is     limited. This devices could improve the treatment of renal dialysis arteriovenous fistula     stenosis.   "
54984|NCT02565940|"     This work also highlights the presence of an unknown virus double-stranded DNA. In this     project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot     infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet     previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a     minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the     most frequent new species frequency in the disease and incidentally get a sense of their role     in the evolution and prognosis of the disease, including failures of and targeted antibiotic     therapy on all 150 samples.   "
54985|NCT02565927|"     The aim of this study was to evaluate the safety and effectiveness of an radioactive airway     stent loaded with 125I seeds compared to a conventional airway stent in patients with     malignant airway obstruction caused by both primary and metastatic malignant tumors.   "
54986|NCT02565914|"     This is a Phase 3, multicenter, open-label, 2-part rollover study in subjects with CF who are     homozygous or heterozygous for the F508del-CFTR mutation and who participated in Studies     NCT02070744, NCT02347657, NCT02516410, NCT02392234, NCT02412111, and NCT02508207. The study     is designed to evaluate the safety and efficacy of long term treatment of VX-661 in     combination with ivacaftor.   "
54987|NCT02565901|"     This partially randomized phase I/II trial studies the side effects and how well sirolimus     works when given together with docetaxel and carboplatin in treating patients with     hormone-resistant prostate cancer that has spread to other places in the body. Biological     therapies, such as sirolimus, use substances made from living organisms that may stimulate or     suppress the immune system in different ways and stop tumor cells from growing. Drugs used in     chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Giving sirolimus together with docetaxel and carboplatin may kill more tumor     cells.   "
54988|NCT02565888|"     This study aims to provide the evidence that 150mg of cobicistat will have the same effect on     the pharmacokinetics of daclatasvir 30mg QD as 100mg of ritonavir, when given together with     atazanavir 300mg.   "
54989|NCT02565875|"     Obstetrics and Gynecology residents, fellows and attending physicians will be randomized to     view one of two educational presentations of equal duration. The intervention presentation     will demonstrate the use of a standardized language for effective communication of     laparoscopy commands. Both groups will be asked to perform a simulated laparoscopic task.     Participants will be timed and use of the standardized language will be tracked and     tabulated. The primary outcome of interest is whether the use of standard commands during a     simulated laparoscopic task is associated with sooner completion of the task. This may     translate into improved efficiency in the operating room.   "
54990|NCT02565862|"     This study aims to provide clinical information on a potential drug-drug interaction between     daclatasvir and metformin.   "
54991|NCT02565849|"     The Sickle Cell Anemia (SCA) is a recessive genetic condition, monogenic, resulting in     defects in the red cell structure. In the investigators' country, this disease affects about     3,000 children each year and is considered one of the most prevalent disorders among the     group of existing hereditary diseases.      The lungs are frequently affected in this disease by Acute Chest Syndrome (STA). Besides     being the leading cause of death and the second leading cause of hospitalization in SCA, the     STA is correlated with cognitive impairment frame these patients, resulting secondary Stroke     vaso-occlusion of capillaries that supply the brain tissue.      Traditional tests of pulmonary function allow assess whether the person has any commitment in     the respiratory system, whether obstructive, restrictive or mixed. To run these tests it is     necessary that the patient understands and performs a forced expiratory maneuver to obtain     reliable results. In the particular case of SCA, performing these tests it is very difficult     due to the presence of cognitive impairment of varying degrees. This results in     underdiagnosis of early changes in the lung parenchyma during the therapeutic window,     committing the proper monitoring and treatment offered to these patients.   "
54992|NCT02565836|"     This study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate     (FEIBA VH, Baxter) versus the variable, manufacturer recommended, dose regimen of inactivated     prothrombin complex concentrate (Kcentra, CSL Behring) for reversal of warfarin-associated     major hemorrhage.   "
54993|NCT02565823|"     The purpose of this study is to find out whether exercise leads to changes in the blood that     are produced by exercised muscles and if these changes produce new hormones that affect the     body's regulation of sugar and body weight.   "
54994|NCT02565810|"     A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects     with Rheumatoid Arthritis.   "
55173|NCT02563457|"     This study will assess the efficacy of periodontal treatment in diabetic patient. Patients     will be randomized in the periodontal group or in the control group. The control group will     received a periodontal treatment after the study.   "
55001|NCT02565719|"     NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both     preclinically (in duck HBV infected ducks) and in human patients. REP 2139-Ca mediated HBsAg     clearance acts synergistically with immunotherapeutic agent pegylated interferon-alpha 2a to     restore host immunological control of HBV infection. REP 2165 is a version of REP 2139 which     has been shown preclinically to retain antiviral activity with lower accumulation in the     liver.      Both REP 2139 and REP 2165 used in this protocol are formulated as magnesium chelate     complexes, which improve their administration tolerability. This open label, randomized and     controlled study will examine the safety and efficacy of REP 2139-Mg and REP 2165-Mg therapy     in patients with HBeAg negative chronic hepatitis B when used in combination with tenofovir     disoproxil fumarate and pegylated interferon alpha-2a.   "
55002|NCT02565706|"     This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition     education lesson to promote farmers' market fruit and vegetable purchases and consumption     among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and     Children (WIC).   "
55003|NCT02565693|"     There is a marked lack of evidence on the optimal prevention of ischaemic stroke in patients     with atrial fibrillation and a recent intracerebral haemorrhage (ICH) during treatment with     oral anticoagulation. These patients are currently treated with vitamin K antagonists,     antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional     preferences. Treatment with a direct oral anticoagulant like apixaban might be an attractive     alternative in terms of a low risk of recurrent ICH, while at the same time being effective     for the prevention of ischaemic stroke. This study aims to obtain reliable estimates of the     rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent     anticoagulation-associated intracerebral haemorrhage who are treated with apixaban versus     those who are treated with antiplatelet drugs or no antithrombotic drug at all.      This study has a multi-centre, phase II, randomised, open-label clinical trial with blinded     outcome assessment design.   "
55004|NCT02565680|"     Acute urticaria is common and affected 12% of population. 400 patients come in department     emergency of Toulouse each year and there aren't many studies in literature which evaluate     the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but     glucocorticoids treatment administered orally for short course would permit to increase     quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded     of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.   "
55005|NCT02565667|"     The most challenge for the surgery of low rectal carcinoma was whether to perform low     anterior resection (LAR) and preserve anal function improving the quality of life for     patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in     reported literature. Up to now, kinds of surgical devices have been employed to reduce     anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the     problem of dog ear phenomena. In the present clinical trial, the investigators use a double     purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for     low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The     investigators aim to demonstrate the safety, effectiveness of this procedure and establish a     standard method for laparoscopic (ultra-)low anterior rectal resection.   "
55017|NCT02565511|"     The purpose of this study is to test whether two investigational drugs called CAD106 and     CNP520, administered separately, can slow down the onset and progression of clinical symptoms     associated with Alzheimer's disease (AD) in participants at the risk to develop clinical     symptoms based on their age and genotype.   "
55006|NCT02565654|"     Irritable bowel syndrome (IBS) is a common disease and the pathogenesis of this disease     includes central and peripheral mechanisms. In recent years, there were many studies     suggesting that microbiota in the intestine may play an important role in the IBS.What's     more, small intestinal bacterial overgrowth (SIBO) may be an important pathogenic factor for     IBS and the use of antibiotics may be beneficial. Therefore, the investigators intend to     explore the efficacy of rifaximin for IBS-D in Chinese population.   "
55007|NCT02565641|"     This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV)     gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The     anticipated time on study treatment is 3 to 12 months, and the target sample size is 56     individuals.   "
55008|NCT02565628|"     This study is designed to assess safety, tolerability and pharmacokinetic data for multiple     doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study     will assess whether PF-06669571 is able to demonstrate superior efficacy compared with     placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.   "
55009|NCT02565615|"     The study is to verify atorvastatin effectiveness and safety in Chinese population, and     explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。   "
55010|NCT02565602|"     This study aims to: 1) quantitatively assess parameters of bone calcium balance in healthy     postmenopausal Asian women of Chinese descent; 2) assess possible ethnic differences in     calcium metabolism by direct comparison of acquired data in Chinese postmenopausal women with     those acquired earlier in Caucasian postmenopausal women using the same methodology; 3)     assess differences in calcium and strontium metabolism in parallel to evaluate if strontium     stable isotopes can be used for tracing bone calcium metabolism qualitatively   "
55011|NCT02565589|"     To investigate natural killer (NK) cell activities, circulating cytokine levels and     peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill     patients.   "
55012|NCT02565576|"     The purpose of this study is to evaluate safety, tolerability,     pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of     care in patients with moderate to severe myasthenia gravis (MG).   "
55065|NCT02564874|"     The objective of this study is to determine the effect different sources and forms of     discretionary foods have on dietary compensation and energy intake in healthy adults in a     free living, real world setting. Specifically, this pilot study will compare the effect of     the greatest caloric sources of savory and sweetened discretionary foods in the American diet     (savory snacks v. sugar-sweetened beverages). The rationale for conducting this study is to     test the mechanism whereby sugar-sweetened beverages are hypothesized to relate to weight     gain and obesity above and beyond other discretionary foods (lack of energy intake     compensation due to liquid form of the beverage), since the evidence for this topic is     limited. The subject population will be 20 men and women between the age of 18 and 59 who are     overweight by body mass index (BMI ≥ 25 kg/m2), generally healthy, consume sugar-sweetened     beverages or , and are willing to incorporate a sweetened beverage or a savory snack into     their usual diet in the 4 week period.   "
55013|NCT02565563|"     The purpose of the study is to gain greater insight into Eye Movement Desensitisation     Reprocessing (EMDR). EMDR is an NHS recommended treatment, which can significantly reduce     trauma symptoms. There is some debate regarding how it actually works, however there is     evidence to suggest that the eye movements component helps reduce anxiety and increase     relaxation levels. To measure these arousal levels during EMDR previous research has used     electrocardiography (ECG) to measure heart rate, which offers insight into the effectiveness     of eye movements (EM). All studies to date have used ECG to measure arousal levels which     requires technical knowledge to administer and interpret. Furthermore, applying electrodes to     a patient experiencing PTSD may heighten anxiety. The present study will use new technology     which is a small device that would be gently attached to the end of the patient's index     finger. This device is very similar to one that measures oxygen levels in the blood and     therefore is a very simple piece of equipment and should cause no discomfort to the patient.     The study also requires patient's faces to be video recorded throughout and it will only be     their face that is recorded. This is to match the stages of treatment (i.e. when EM starts     and stops) to their corresponding arousal level outcome. The new technology will digitally     measure the patient's anxious and relaxed arousal levels during EM and no EM treatment     sessions. 10 NHS patients would be recruited to receive two treatment sessions; one with EM     and one without and then continue with treatment as usual without any of the recording     devices. EM and no EM phases occur at least three times within a treatment session and     therefore several measurements can be taken and analysed.   "
55014|NCT02565550|"     To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota     community is associated with its efficacy.   "
55015|NCT02565537|"     The investigators are comparing outcomes of LASIK surgery using a high definition     wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with     and without astigmatism.   "
55016|NCT02565524|"     Childhood schizophrenia early dissociative disorder is a rare disease with a low incidence     of approximately (1 0/00 to 30/00 ). Its link with autism spectrum disorders remains unknown     although both are serious neurodevelopmental diseases. As part of the 2011-2013 Interregional     hospital Clinical Research program, University Department of Child and Adolescent Psychiatry     Pediatric Hospitals of CHU (Centre Hospitalier Universitaire) de Nice Lenval identified 15     patients with a complex phenotype characterized by an early schizophrenia associated with     autism spectrum disorders and developmental disabilities in mild to moderate. This phenotype     could be a new syndrome called schizotiste.      The goal of the investigator's project is to define the genetic causes of this phenotype. The     technique of high throughput sequencing will be used to obtain the sequence of exomes of     these patients and their families. This study will therefore be important to give an accurate     diagnosis for patients and their families. Moreover, investigators believe that this project     will identify new genes involved allowing a better understanding of the pathophysiology.     Recent studies show the involvement of mutations in several genes (eg Shank, NLGN, NRXN and     UPF3) in these different clinical phenotypes. However, the genetic basis of the child's     schizophrenia are much less well known than those of autism spectrum disorder.   "
55018|NCT02565498|"     This study is designed to determine if preoperative image guided radiation therapy (IGRT)     delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in     similar short-term wound healing complications as surgery followed by postoperative IGRT in     patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive     preoperative radiotherapy, half will receive postoperative radiotherapy.   "
55019|NCT02565485|"     Epidural anesthesia, the most common method of pain control in labor, can contribute to     alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the     administration of an IV fluid bolus (preload) is standard prior to epidural placement.     However, the optimal volume of preload is unknown and no clinical trials have evaluated a     risk-factor based approach to dosing. Studies in the critical care, trauma, and obstetric     literature have suggested that a narrow pulse pressure (difference between systolic and     diastolic blood pressures) is a marker of reduced intravascular volume status and may     identify women at a higher risk for new onset fetal heart rate changes after epidural     placement. Therefore, the purpose of this study is to assess if an increased IV fluid preload     bolus among women with a narrow pulse pressure reduces the risk of new onset fetal heart rate     changes after epidural placement.   "
55020|NCT02565472|"     The goal of this study is to determine subjective gastrointestinal tolerance response and     differences in breath hydrogen response following the consumption of two types of juice. This     double-blind crossover study requires participants to arrive to the lab 12 hours fasted,     consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as     produce samples for breath hydrogen analysis at various time points over the next 3 hours.     Subjects will be asked to complete additional questionnaires at 12 and 24 hours post     consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior     to their scheduled visit times to assure compliance.   "
55021|NCT02565459|"     The general aim of the present study is to test a cell therapy with third-party ex-vivo     expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce     tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared     accordingly to established protocols, starting from the remnants in the bag and filter at the     end of the bone marrow infusions. From these samples, MSCs will be expanded in good     manufacturing practice (GMP) approved facilities and used for the present study in patients     undergoing kidney transplantation.      The proposed study will be developed in two phases: i) a pilot explorative     safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).   "
55066|NCT02564861|"     This is a randomised, double-blind, placebo-controlled multiple dose study designed to     explore the safety, tolerability and PK of DS-1971a following oral administration over 14     days to healthy male and female subjects. Each participant receives lidocaine as a local     anaesthetic before inserting the intravenous cannula.   "
55022|NCT02565446|"     A variety of liver insults lead to pathological changes in liver architecture that culminate     in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development     of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver     fibrosis through non-invasive means that involve measurement of liver stiffness. However, a     number of pathological findings occur in liver in response to various insults that precede     cirrhosis and are clinically important to identify such as steatosis associated with NASH,     inflammation associated with viral hepatitis, and congestion associated with cardiac     hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and     treatment information but yet is not available non-invasively. Recent murine studies from     this group of investigators has identified that MRE technology can be adapted to     non-invasively detect these conditions. Implementing this into the practice will transform it     by obviating the need for invasive liver biopsies in patients suspected of having such forms     of suspected liver disease. This will differentiate Mayo from other institutions where such     technology is not available.      An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on     the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of     obesity. Recent evidence indicates a potential link between OSA and severity of NASH and     fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in NAFLD     is unclear. This study offers the unique opportunity to analyze this association, as the     study population will undergo routine evaluation for OSA, as part as the preoperative work-up     prior to bariatric surgery.   "
55023|NCT02565433|"     The aim of the study is to assess prospectively the impact of radiosurgery on the quality of     life in patients with brain metastases.   "
55024|NCT02565420|"     Perioperative volumes of saline cause a mild acidosis compared with buffered fluids. On the     other hand, saline administration maintains plasma osmolality and better repletes vascular     volume which is an important goal of perioperative fluid administration. Currently, there is     no convincing evidence that either saline or buffered solutions are preferable. Consequently,     both types of fluid remain in common use at the Clinic and worldwide.      There has never been a large trial of perioperative saline and balanced salt solutions     comparing the incidence of major complications including acute kidney injury. The     investigators primary objective is thus to determine the relative safety of perioperative     saline and lactated Ringer's solution. Specifically, the investigators propose to test the:        1. Primary hypothesis that a composite of major in-hospital postoperative complications is          lower in patients given lactated Ringer's solution compared to normal saline.        2. Secondary hypothesis that acute kidney injury, measured by AKIN criteria, is lower in          patients given lactated Ringer's solution compared to normal saline.      The acquisition cost of saline and lactated Ringer's solutions is similar in the United     States. (Curiously, buffered solutions are far more expensive than saline in Great Britain.)     But to the extent that one fluid or the other provokes more complications, cost of care may     be increased with that fluid selection. Cost may also be increased by the need for additional     electrolyte monitoring and electrolyte replacement.      The investigators will therefore secondarily conduct an economic evaluation to determine the     relative incremental hospital cost of each fluid. To the extent that one fluid or the other     reduces cost (assuming similar complication rates), the Clinic will be able to reduce cost by     specifying the appropriate fluid without impairing quality.      Evidence that one fluid or the other causes few complications would be a strong quality     indicator that the Clinic should standardize perioperative fluid selection.   "
55025|NCT02565407|"     This study investigates the effect of a robot-aided 2-day proprioceptive training of the     wrist on the proprioceptive and motor function of the wrist/hand complex in patients with     proprioceptive impairment. The wrist proprioceptive training consists of active movement     training with augmented haptic and vibro-tactile feedback provided by a patented wrist     robotic system (US Serial No. 62/136,065). This study protocol can be applied to a variety of     clinical and non-clinical populations. The purpose of this study is to obtain preliminary     data on the effectiveness of the proprioceptive training in subjects with cortical stroke or     peripheral sensory neuropathy.   "
55026|NCT02565394|"     Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high     physical and mental demands while enhancing performance during surgical procedures?   "
55027|NCT02565381|"     The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm     pilot randomized controlled trial that will test the effect of 2 different experimental     smoking cessation interventions relative to a control condition in homeless cigarette     smokers. All participants will receive free transdermal nicotine patches and weekly in-person     smoking cessation counseling. In addition, participants randomized to the first experimental     condition will receive financial rewards for biochemically-verified smoking abstinence, and     participants randomized to the second experimental condition will be enrolled in a text     messaging program to support smoking abstinence.   "
55028|NCT02565368|"     This study is a randomized, open-label, single dose, 2-way crossover study to compare the     pharmacokinetic characteristics of CKD-395 0.5/1000 mg in healthy male volunteers.   "
55029|NCT02565355|"     Recurrent Abdominal Pain (RAP) in children is common and causes significant functional     impairment and poor quality of life. Lifestyle factors such as diet, anxiety, and stress are     important triggers of abdominal pains, but there is lack of high quality research evidence on     optimal treatment modalities in children. This study aims to evaluate the effect of food     elimination on abdominal pain frequency and severity in a cohort of children with abdominal     pain associated Functional Gastrointestinal Diseases (FGID). The primary outcome will be a     comparison of abdominal pain frequency and severity between standard therapy and targeted     food elimination, based on IgG antibody results to a multiple food antigen panel. The     investigators anticipate that 'targeted dietary elimination' as a treatment strategy will     resolve abdominal pain and improve quality of life in children.   "
55030|NCT02565342|"     The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks     aimed at relieving pre- and post-operative pain include the superficial cervical plexus     blocks, interscalene blocks and a combined version of the above. In this case study, the     investigators aim to describe the protocol used in a university hospital: general anaesthesia     with interscalene brachial plexus block, followed by optional iv morphine administration in     phase 1 recovery and oral oxycodone on the ward.   "
55031|NCT02565329|"     The study aimed to evaluate the correlation between the serum lactate concentration ed     cumulative Pringle time after liver resection. In addition, the correlation between lactate     clearance and clamping time was investigated.   "
55067|NCT02564848|"     This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without     sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative     breast cancer. Clinically node-negative means that during a physical exam your doctor cannot     feel or see that any lymph nodes near the breast area are swollen and there is also no     imaging evidence, such as from a mammogram, of nodal involvement.   "
72150|NCT02341352|"     Analysis different measures preventive effect on carious Lesions incidence and oral     microecological system change of preschool children   "
55032|NCT02565316|"     The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety     herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial.     A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz     medical university, who having depression according to Persian‐language version of the Beck     Depression Inventory‐Second edition and get score above 11 according to Persian version of     Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly     allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta     menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and     1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation,     allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous     suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and     hypothyroidism and patients who used substances or alcohol and patients who had indication     for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety     Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd     week, 4th week and then two weeks after the end of the intervention (in 6th week)   "
55033|NCT02565303|"     Ropivacaine is one of commonly used anesthetics for spinal anesthesia. Usually L2-3 or L3-4     intervertebral space is chosen for spinal anesthesia. The efficacy of ropivacaine injected     into subarachnoid space depends on the given dose and the chosen intervertebral space.     Appropriate dose could satisfy the requirement of operation and reduce incidence of the     adverse reaction. But it is not certain about the minimum effective dose of ropivacaine in     cesarean section through the two intervertebral spaces, respectively. This study is being     conducted to find the minimum effective doses for L2-3 and L3-4 spinal anesthesia in cesarean     section.   "
55034|NCT02565290|"     The effect of anti-inflammatory substances on the dynamics of the fetal ductus arteriosus is     well documented, but the anti-inflammatory property of polyunsaturated fatty acid omega-3     about changing this dynamic is not established. This study evaluate the relationship between     supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third     trimester. Women with gestational between 28 to 32 weeks will receive capsules of omega-3 or     placebo, to be consumed daily for 3 weeks.   "
55035|NCT02565277|"     To assess the impact of influenza vaccination on the overall systemic inflammatory response     in patients undergoing cardiac surgery and investigate functional and clinical outcomes in     vaccinated patients postoperatively.   "
55036|NCT02565264|"     This study is an open prospective clinical trial. The objective is to evaluate the effect of     autologous exosomes rich plasma on cutaneous wound healing. The participants are patients     with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease,     chronic venous insufficiency, decubitus or burns). The participants will be treated     autologous exosomes rich plasma every day for 28 days. The cutaneous wound healing will be     evaluated by the length, width and depth of the wound.   "
55048|NCT02565108|"     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The     blinded phase only will be described in this record. Participants will be randomized in a 4:1     ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of clobazam     (CLB) and its major metabolite (N-CLB) may be altered (increased or decreased) as a result of     using GWP42003-P.   "
56014|NCT02552433|"     The objective of this study is to describe the wound related complication rate in     post-bariatric body contouring surgery patients who are treated according to the new Dutch     guideline and to asses the factors associated with a higher complication rate.   "
55037|NCT02565251|"     Severe sepsis and septic shock are among the leading causes of morbidity and mortality in     patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the     USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of     this condition may lower the associated morbidity and mortality.      The hemodynamic profile of the septic shock is characterized by the presence of the     distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks.      The objecive of this study is to optimize the volemic resuscitation of the severe septic and     of the septic shock patient using two minimally invasive methods of hemdynamic monitoring     which both use the same device (Edwards Lifescience). In the same time hemodinamic data will     be colected by mesuring the inferior vena cava diameter.   "
55038|NCT02565238|"     The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is     collected to support the regulatory approval of this product in countries outside the CE     region.   "
55039|NCT02565225|"     The purpose of this study is to evaluate the use, usability and feasibility of an Application     (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician     interaction.   "
55040|NCT02565212|"     The investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory     functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty     patients with seasonal were included in this study. Patients were randomly divided into three     groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy,     group 2 received only montelukast, and group 3 only mometasone furoate. Patients' olfactory     functions were determined using the Sniffin' Sticks olfactory test before and after a month     treatments.      Threshold, discrimination, identification, and TDI values were not significantly different     among the groups before treatment. For Group 1 and Group 3 patients, there were statistically     significant differences in threshold, discrimination, identification, and TDI values before     and after treatment (p < 0.05) (Wilcoxon signed ranks analysis) For Group 2 patients, the     before and after treatment values of threshold, discrimination, identification, and TDI     showed no significant differences (p > 0.05). According to the findings of our study, MF is     superior to montelukast in improving olfactory function. Although montelukast has been shown     to be effective against AR symptoms, its effect on olfactory function was not demonstrated in     this study.   "
55041|NCT02565199|"     The goal of the study is to determine the effect of repetitive transcranial magnetic     stimulation (rTMS) over the premotor cortex on training-related improvements in motor     performance and associated neural plasticity.   "
55042|NCT02565186|"     This is a prospective, randomized, open-label study in subjects with migraine who have     completed CoLucid Phase 3 study, COL MIG 301 or COL MIG-302. The study is designed to     evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and     of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of     migraine. Long term efficacy will also be evaluated.   "
55068|NCT02564835|"     The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga     and to begin to assess whether yoga is effective in improving attention and immune function     in individuals with colorectal cancer compared to physical activity and usual care.   "
57152|NCT02537470|"     This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of     doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered     over 12 weeks in subjects with type 2 diabetes mellitus.   "
55043|NCT02565173|"     Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic     formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or     timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary     Open-Angle Glaucoma.      All subjects who meet the study's enrollment criteria following Screening will undergo     washout of all prohibited medications, including their routine glaucoma medications. During     the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects.     During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks     followed by an Observation Period of approximately 7 days wherein no study eye drops are     instilled.      The purpose of the study is to assess the efficacy, tolerability, and safety of binocular     topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12     weeks.      Timolol is being included in the trial in order to have an active control to ensure the     integrity of the trial from an efficacy perspective; the primary comparator for all     statistical purposes is the placebo arm.   "
55044|NCT02565160|"     Making the diagnosis underlying a painful, swollen joint currently involves aspiration     followed by numerous microbiological and biochemical laboratory tests. This can be costly,     time consuming and in the case of an acutely swollen joint, lead to a lengthy inpatient     admission. There is an unmet need to provide a quick, easy, reliable dipstick like test to     analyse joint fluid in the community, clinic, or emergency department setting.      The investigators aim to use well established metabonomic techniques to:        1. Analyse fluid from patients with swollen joints        2. Identify potential biomarkers of inflammatory, infective and osteoarthritic causes of          joint swelling        3. Correlate this with lubrication and wear properties of the fluid The long term goal is          to develop time saving, cost effective, non-invasive diagnostic tests to improve          management of a swollen joint. The biomedical research centre at Imperial provides a          unique and unparalleled clinical and scientific environment to conduct this research.          The Imperial College division of Computational and Systems Medicine has an international          reputation in metabonomics and this, together with the high volume of patients with          swollen joints treated at Imperial National Health Service Trust (c1000/yr) ensures that          the study can take place in an environment conductive to success.   "
55045|NCT02565147|"     The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent of     the damage done to the heart muscle in patients who suffered a heart attack, compared to the     comparator treatment (heparin).   "
55046|NCT02565134|"     The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in     male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID     topical applications of PAC-14028 cream or vehicle for up to 4 weeks.   "
55047|NCT02565121|"     The aim of the study is to see whether patients with chronic smell impairment after brain     injury benefit from a treatment that consists of corticosteroids, and then olfactory training     in 3 months.   "
55049|NCT02565095|"     It is well documented that a few days stay in space induces a change in the vestibular-ocular     reflex reflecting a reinterpretation of sensory inputs following the disappearance of     gravity. If the change of eye reflexes actually the result of a reinterpretation of sensory     input, the investigators should also expect to see an alteration of the     vestibular-cardiovascular reflexes. The modification of these reflexes may modulate the     carotid baroreflex and thus participate in the post-flight cardiovascular deconditioning.      The first objective of this project is to study the carotid baroreflex under different supine     (dorsal, ventral and lateral) inducing different otolith stimulation in normal-gravity.   "
55050|NCT02565082|"     Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid     sequence of the β chain of hemoglobin.      The most expressive and most frequent complication of the disease is vaso-occlusive crisis,     dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic     biological disturbances are observed in sickle cell patients.Sickle cell disease is     considered nowadays as a hypercoagulable state.      However, the approach used so far to the measure of clotting in sickle cell disease was     segmented in the sense that the various components of the hemostatic balance were studied     separately.The thrombin generation test is a functional test which explores the coagulation     globally, integrating both pro players that anticoagulants actors in the system. The     investigators already used this test to demonstrate that the hemostatic potential was high in     a cohort of affected children compared to control children of the same age.      This test will be used to characterize the hemostatic potential of adult sickle cell patients     followed at the CHU Brugmann Hospital.   "
55051|NCT02565069|"     The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D     Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the     treatment of complex arrhythmias.   "
55052|NCT02565056|"     The purpose of this study is to assess the feasibility of conducting a trial to evaluate a     self-help treatment for depression in people with end-stage renal disease.   "
55053|NCT02565030|"     This study will help to provide more up to date prognostic data on the natural history of     untreated proximal CTEPH which will be helpful in discussions regarding surgical versus     medical treatment and by exploring the similarities and differences between distal CTEPH and     IPAH the investigators hope to get insights into disease mechanisms in patients with distal     CTEPH.   "
55054|NCT02565017|"     The purpose of this study is to learn what cancer patients think about IBM Watson Oncology.     IBM Watson Oncology is a computer program designed to help inform oncologists about the best     chemotherapy choices for their patients. The investigators will conduct focus groups with     cancer patients who have received chemotherapy treatment at MSK in order to understand cancer     patients' thoughts about IBM Watson Oncology.   "
55069|NCT02564822|"     The aim of this study is to investigate the motor and visual cortex excitability in response     to visual stimulation of migraineurs with and without aura compared to healthy individuals.     For this purpose, electrical cortical activity of migraineurs will be compared to healthy     volunteers.   "
55055|NCT02565004|"     Background:      DNA makes up the instruction book for people s cells. Cancer is a disease caused by DNA     changes that build up and affect cell function. Researchers want to learn more about what may     cause cancer by testing the DNA of people with the disease and their family members.      Objective:      To find DNA changes that may be inherited and may cause or influence whether a person gets     cancer. To study families with clusters of cancer to find out if there is a DNA mutation     specific to certain cancers.      Eligibility:      People 18 years of age and older who:      Participated in the familial genetic part of NIH study 09-C-0079, a previous study or had     family members enrolled in this study      Design:      Participants may have been screened in the previous study. They will give permission for     researchers to use their data and their tissue or blood samples collected in the study.      Participants may give blood samples.      At each stage of testing, participants will meet with a genetics health care provider. The     provider will explain the tests and answer questions.      If researchers find a DNA change that might increase the risk for cancer or other health     issues, they will confirm this result in a testing lab. This will require a blood sample.      Participants personal DNA data and health information will be put in a database for research     purposes.   "
55056|NCT02564991|"     Background:      The way alcohol affects brain structure has been widely studied. But the way it affects all     parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI)     scans to study brain structure and function. They hope this will help them better understand     changes that happen in brain regions during treatment of alcohol use disorders.      Objectives:      To study changes in the brain by using MRI in people with and without alcohol use disorders.     To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how     the brain recovers when alcohol use stops.      Eligibility:      People with alcohol dependence who are currently hospitalized in a particular unit at NIH.      Healthy volunteers 30 60 years old without an alcohol use disorder.      Design:      Participants will be screened under a separate protocol.      Participants will give a urine sample for a drug test and pregnancy test at each study visit.     They will also have to pass a breath alcohol test.      At the first visit, participants will have an MRI. The scanner is a metal cylinder in a     strong magnetic field. Participants will lie on a table that slides in and out of the     cylinder.      They will do behavior and memory tasks outside the scanner.      They will have gait and balance tested. They will have to stand on both legs, stand on just     one leg, and walk in a straight line. They will perform each task with eyes open, then with     eyes closed.      They will have tests of memory, thinking, and problem solving.      Some participants will have a second visit. They will have another MRI and repeat some of the     behavior and memory tasks.   "
55078|NCT02564705|"     The aim of this study is to compare outcomes and cost-effectiveness of anterior versus     posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is     to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry     Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related     adverse events. Secondary objectives are to compare treatments in terms of differences in     pain, quality of life, health utilities, and need for re-operation. Finally, a     cost-effectiveness analysis will be performed. This analysis will take the form of     cost-effectiveness if there is a difference in treatment effects or cost-minimization if     there is no difference in treatment efficacy.   "
55057|NCT02564978|"     Background:      Age-related macular degeneration (AMD) is the main reason older people lose their vision. It     affects the macula, the center of the retina needed for sharp, clear vision. Researchers want     to see if an antibiotic can help people with an advanced form of AMD, Geographic Atrophy     (GA).      Objective:      To see if minocycline is safe for people with GA and if it helps preserve their vision.      Eligibility:      People age 55 and older who have GA in at least one eye.      Design:      Participants will be screened with physical exam, medical history, blood tests, and eye exam.      Participants will be assigned to take either minocycline or placebo. They will take 1 pill     twice a day for at least 3 years.      Participants will have study visits every 6 months for at least 3 years. At each visit,     participants will have a medical history. They may have:      Blood tests.      Eye exam. Vision, eye pressure, and eye movements will be checked. The pupils may be dilated.     The inside of the eyes may be photographed.      Their thyroid gland felt while they swallow.      Microperimetry. They will sit in front of a computer and press a button when they see a light     on the screen.      Fluorescein angiography. An intravenous line (IV) will be placed in an arm vein. A dye called     fluorescein will be placed in the IV and travel through the veins to the blood vessels in the     eyes. A camera will take pictures of the dye as it flows through the eye blood vessels.      Participants will be contacted by phone periodically between visits. They will answer     questions on their visual function once every year.   "
55058|NCT02564965|"     The purpose of this study is to determine optimal treatment strategies for symptomatic     walled-off pancreatic necrosis( WON).   "
55059|NCT02564952|"     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The     open-label extension phase only will be described in this record. All participants will     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or     increase the participant's dose until the optimal dose is found.   "
55060|NCT02564939|"     Delirium is a common morbid condition in hospitalized adults. Treatment of delirium has been     unsatisfactory and prevention is the preferred goal. Based on limited experimental research,     ramelteon appears to have promise for prevention. This study will evaluate ramelteon in     prevention of delirium in a hospitalized adult population age 65+ in a double-blinded RCT.   "
55061|NCT02564926|"     To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month,     randomised, open-label, parallel-group, multi-centre phase IV study.   "
55062|NCT02564913|"     In traditional Chinese medicine (TCM), examination of the tongue plays an important role in     diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur,     teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of     the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia,     which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing     hyperglycemia can also be associated with buccal alteration. The purpose of this study was to     survey on tongue diagnosis and other examinations associated with diabetic mellitus.   "
55063|NCT02564900|"     This is an open-label, two-part, multiple study to evaluate the safety and tolerability of     DS-8201a in patients with advanced solid malignant tumors.   "
55064|NCT02564887|"     Patients with head and neck cancer treated with chemoradiation, often develop a treatment     associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks     to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced     dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer.     This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise     alone to determine if recovery is enhanced and to determine if rate of recovery is     accelerated.   "
55070|NCT02564809|"     The investigators will conduct a 8-week proof-of-concept randomized controlled trial to     provide preliminary evidence of efficacy of Fit Brains (Rosetta Stone Canada) training -- a     mobile cognitive training program -- on cognitive and brain plasticity in older adults. The     investigators will also explore whether Fit Brains training paired with a brief bout of     exercise would enhance the potential cognitive benefits of Fit Brains. In addition, the     investigators will explore the long-term effects of cognitive training by performing a 1-year     follow-up measurement (i.e., 1-year after study completion).   "
55071|NCT02564796|"     Cyanotic congenital cardiac patients require higher hemoglobin concentrations (red blood cell     levels) for optimal oxygen delivery to the body. Prophylactic erythropoietin (EPO) and iron     can prevent and/or decrease the amount of blood transfusions needed in this population. We     seek to investigate if EPO and iron make a clinically significant difference in the number of     transfusions given to these patients and the morbidity associated with it.   "
55072|NCT02564783|"     PURPOSE OF THE STUDY      The main purpose of this study is to find out what is the true burden of surgical conditions     in pediatric population in a well defined geographical rural area in western Kenya.   "
55073|NCT02564770|"     This is a cross-sectional, observational study examining the factors leading to the     therapeutic decision to use MabThera (rituximab) in participants with RA. Routine     rheumatology clinical practice data of participants who are being or have been treated with     rituximab for RA will be collected and analysed in this chart review.   "
55074|NCT02564757|"     The investigators will examine if pregnancy increases risk of ventral hernia recurrence   "
55076|NCT02564731|"     This prospective cohort study is designed to observe of the effect of intervention therapy on     the long-term prognosis of children with bronchiectasis. The main purpose of the study was to     evaluate the degree of deterioration of lung function, to observe and compare the quality of     life, the time of pulmonary exacerbation, and the changes of lung image.   "
55077|NCT02564718|"     The purpose of this study is to find out whether rivaroxaban is safe and effective to use in     children age newborn to less than 6 months and how long it stays in the body and how it is     used in the body. Safety will be assesed by looking at the incidence and types of bleeding     events. There will also be a check for worsening of blood clots.   "
55114|NCT02564224|"     Temporary stomas has been performed to reduce complications after colorectal cancer surgery,     especially in high-risk anastomosis. Different closure technics showed different outcome. The     aim of this study is to compare the VSS score , surgical site infection and pain score of     pursestring wound closure vs conventional closure.   "
55079|NCT02564692|"     The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large     group of people interested in participating in research studies or clinical trials based in     part on their genetic background. This genetic information will be used to match interested     individuals to studies, providing a recruitment resource to the Alzheimer's scientific     community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the     GeneMatch program.   "
55080|NCT02564679|"     Pediatric obesity has become a critical health problem worldwide, increasing the premature     onset of obesity-related morbidities. This phenomenon has induce an increase in the incidence     of serious health complications starting in childhood and adolescence. Lifestyle     interventions, including diet and regular physical activity, are the cornerstone of current     medical management. Unfortunately, these interventions are often ineffective in providing a     meaningful and long-lasting weight loss necessary to change health outcomes. It has been     demonstrated that an early intervention in obesity in children and adolescents, inducing     weight loss by performing bariatric surgery in carefully selected patients, can dramatically     reduce the risk of adulthood obesity and obesity-related diseases, including non-alcoholic     fatty liver disease (NAFLD).      Recent evidence suggest that bariatric surgery can improve metabolic complications and liver     involvement in patients affected by morbid obesity.   "
55081|NCT02564666|"     Sorafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects     used as systemic treatment in patients with unresectable hepatocellular carcinoma.      Although sorafenib has demonstrated many clinical benefits in patients, its adverse cannot be     ignores.      This drug occasionally causes severe adverse events (AEs), which include hand-foot skin     reaction (HFSR), hypertension, diarrhea, anorexia, fatigue, weight loss, and so on. Although     most adverse events are reversible, they can significantly impact a patient's quality of life     and occasionally result in dose reduction or discontinuation of therapy Patients are also     more likely to remain on treatment if they are guided over the difficult initial 4~6wks of     therapy during which time the development of adverse events following sorafenib treatment     initiation are most likely to occur.      Patient education, proactive management and establishing and maintaining open communication     between patients and the nurse are crucial to the effective management of these adverse     events.      This study design is a randomized controlled trial and 64 patients will be randomized to one     of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the     rest of 32 patients will be enrolled into the intervention group. The intervention group will     be received the routine telephone calls of six times at intervals of once a week during 10~15     minutes (from a well-trained nurse)      The purpose of this study is to confirm whether an effective intervention that telephone     counseling and education by a nurse can increase drug compliance for patients with HCC who is     taking Sorafenib and is to use for developing individual educational program as a fundamental     data that can be applied for patients taking Sorafenib after investigating patient     satisfaction by The Satisfaction with information about Medicines Scale(SIMS) tool.   "
55102|NCT02564380|"     A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance     Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous -     Non-Small Cell Lung Cancer (sNSCLC).   "
55103|NCT02564367|"     Multicenter trial in Germany:      Feasibility Study of Adjuvant Treatment with S-1 in Patients after R0-Resection of     Adenocarcinoma of the Stomach and Esophagogastric Junction with the aim to show the     feasibility and tolerability of two different adjuvant S-1 treatment regimens in Caucasian     patients and to determine the recommended dose for both treatment regimens.   "
74531|NCT02310204|"     The primary objective of this research protocol is to assess the effect of a structured     therapeutic education program on the quality of life of patients with moderate to severe     psoriasis   "
55082|NCT02564653|"     Vietnam has a smoking prevalence that is the second highest among South East Asian countries     (SEACs). With a population of approximately 90 million, Vietnam also has the second largest     total number of adult smokers (over 16 million) in SEA. According to the World Health     Organization (WHO), most reductions in mortality from tobacco use in the near future will be     achieved through helping current users quit. Tobacco use treatment, as defined by the U.S.     Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is     evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of     recommended care is suboptimal. The objective of this proposal is to fill the current     research-to-practice gap by conducting a randomized controlled trial that compares the     effectiveness and cost effectiveness of two practical and highly replicable strategies for     implementing evidence-based guidelines for the treatment of tobacco use in public health     clinics in Vietnam. The proposed implementation strategies draw on evidence-based approaches,     and the WHO's recently released guidelines for implementing Article 14 of the Framework     Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed     by the WHO in response to the globalization of the tobacco epidemic. Vietnam ratified the     FCTC in 2004; however, they have not taken steps to implement Article 14 which specifies the     need to integrate best practices for treating tobacco use and dependence into routine     preventive care. The proposed implementation strategies also build on the growing literature     that supports the effectiveness of integrating community health workers as members of the     health care team to improve access to preventive services.   "
55083|NCT02564640|"     Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might     attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs     comparatively less airway manipulation so, the investigators expect less hemodynamic response     while using videolaryngoscope.   "
55084|NCT02564627|"     A prospective randomized study, including moderately obese patients will be included.     Patients will be randomized in 3 groups:        -  PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet        -  PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet        -  Only 1200Kcal/day diet      The effect on appetite and weight loss will be investigated.   "
55085|NCT02564614|"     This open-label study will demonstrate proof-of-mechanism of HIF1A inhibition by a decrease     of HIF1A mRNA after intravenous (IV) infusion of RO7070179 in participants with     hepatocellular carcinoma (HCC) who have failed at least one line of systemic therapy. This     will be a single arm study and all participants will receive RO7070179, 13 milligram per     kilogram per week (mg/kg/week), 2-hour IV infusion on Days 1 and 4 during Week 1 of Cycle 1,     followed by once weekly in 6 week cycle. Treatment with RO7070179 will be continued until     disease progression or unacceptable toxicity.   "
55115|NCT02564211|"     This is a study to assess the safety and efficacy of the addition of ipragliflozin to     sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate     glycemic control on sitagliptin, diet, and exercise therapy.   "
72600|NCT02335463|"     The investigators will use an advanced high resolution 3D optical coherence tomography (OCT)     technology to observe colon and skin images in ex vivo.   "
55086|NCT02564601|"     This project evaluates the effects of piano training and computerized cognitive training on     cognitive performance in healthy older adults compared to controls. The project is intended     for healthy older adults (60-80 years) with little to no previous musical training (less than     three years of prior musical training or cognitive training and not currently engaged in     music reading or musical performance, less than 10 hours of previous cognitive training).     Investigators anticipate that musical engagement will serve as an enjoyable cognitive     intervention for older adults. Investigators believe that piano training will enhance     cognitive performance on executive functions essential for maintaining independence in older     adulthood. Learning a musical instrument, while challenging, will improve self-efficacy,     mood, and qualtiy of life. Participants engaged in piano training will demonstrate reduced     cortisol levels and increased immune function responses. Investigators predict that adults     enrolled in computerized cognitive training will demonstrate enhanced memory, working memory     and self-efficacy post-training.   "
55087|NCT02564588|"     Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with     moderate to severe Binge Eating Disorder (BED)   "
55088|NCT02564575|"     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the     HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.   "
55089|NCT02564562|"     The study aims to understand, using radiolabelled PF-06463922, how this compound is modified     by the body once it is absorbed. The study also aims to understand how much of the compound     is broken down and how much leaves the body unchanged.   "
55090|NCT02564549|"     Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and     targeted biopsies for men with low risk prostate cancer on active surveillance with any     volume Gleason's Score 6, but no prior MRI imaging of the prostate.   "
55091|NCT02564536|"     For the first 28 day cycle, all patients will be treated with single agent pacritinib at 200     mg twice daily. The investigators chose this starting dose based on the previous three phase     I studies of pacritinib as a single agent which showed that the maximum tolerated dose (MTD)     to be 500 mg, and subsequently, the dose of 400 mg daily was recommended for the phase II     studies.      Recently, the results of the phase III PERSIST-1 trial comparing pacritinib to best available     therapy (BAT) in patients with MF was reported at the 2015 American Society of Clinical     Oncology (ASCO) annual meeting. Pacritinib was found to be significantly more effective than     BAT at reducing spleen volume at 24 weeks of therapy and improving constitutional symptoms.      Low dose decitabine has demonstrated depletion of DNMT1 in normal hematopoietic stem cells     (HSC) without cytotoxicity and subcutaneous (SC) instead of intravenous (IV) administration     may avoid high peak levels that can cause apoptosis. Furthermore, the low toxicity associated     with low dose decitabine would allow for more frequent (1 to 3 times weekly) administration     of the drug which would catch more cells in S-phase via greater exposure time. Based on these     findings, a starting dose of decitabine 5 mg/m2 SC twice weekly should be well tolerated and     effective in patients with MF and MPN/MDS syndromes when combined with pacritinib 400 mg     daily.   "
55092|NCT02564523|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of three     heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study     will include healthy adults and elderly participants, HIV infected participants and healthy     children in 2 age strata.   "
55093|NCT02564497|"     The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept     relative to Process C belatacept in Healthy subjects   "
78391|NCT02259816|"     Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in     combination with repeated doses of 10 mg amlodipine   "
55094|NCT02564484|"     This observational study is designed to establish induced pluripotent stem cells (iPSCs) from     childhood cancer survivors who did or did not develop persistent treatment-induced peripheral     neuropathy, from which to make human neurons for comparing their sensitivity to vincristine     and other potentially neurotoxic drugs.      Investigators will assess the effects of inherited genome variations on treatment-induced     peripheral neuropathy that persists in adults who were cured of childhood cancer. Cells from     childhood cancer survivors who did or did not develop drug-induced neuropathy will be     isolated and induced to become neurons. Cell sensitivity to anticancer agents will be tested     in both groups and compared to determine if the survivors have genetic variants that     correspond to those identified in companion genomic studies. This will assist in determining     if gene variants increase the risk of treatment-induced neurotoxicity.      The investigators are interested in detecting changes of phenotype pre-post treatment in each     group (cases, controls) respectively, as well in comparing the pre-post treatment phenotypic     changes between the two groups (cases vs. controls).   "
55095|NCT02564471|"     This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune     response generated by rabies vaccine when administered for post-exposure prophylaxis. This     study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies     immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis     regimen.   "
55096|NCT02564458|"     Purpose: The primary hypothesis of this study is that the combination of interval exercise     training (IET) as well as motivational accelerometry (MA) delivered both as a 5-12 week     intervention that will improve cardiorespiratory fitness in patients preparing to undergo     allogeneic hematopoietic cell transplantation (alloHCT). MA is not an established term, but     in respect to this study, MA refers to the use of wearable accelerometry paired with regular     intervals of physical activity coaching from members of the study staff during the IET     training. The study will also look at several secondary endpoints including the association     of the intervention with changes in cyclin-dependent kinase inhibitor 2A, multiple tumor     suppressor 1 (p16INK4a), and the association of the intervention with changes in symptoms and     quality of life before and after transplant.      Participants: 60 patients will be randomized into two groups, 30 in the intervention group     consisting of both IET and MA, and 30 in the control group applying usual care and use of     wearable accelerometry without motivational physical activity coaching.      Procedures (methods): Results of this study will inform a randomized, multi-site study of a     pre-transplant exercise intervention.   "
55097|NCT02564445|"     This is a 36-week, three-arm randomized, controlled trial using a team-based model to compare     two weight loss programs to control. Each intervention will use insights from behavioral     economics to leverage social incentives and gamification.   "
55098|NCT02564432|"     The purpose of this study is to investigate the clinical implementation of a new percutaneous     prosthetic attachment system by determining the resident microbial ecology of the implant     exit site and to simultaneously study the systemic and local stomal immune responses. This     study will follow 10 patients implanted with percutaneous osseointegrated prosthetics (POPs)     for a period of one year. Two state-of-the-art, pre- and post-surgery bacterial monitoring     technologies will be used; these procedures are intended to facilitate the early prediction,     detection, and treatment of infection, as well as to provide follow-up data that can     potentially be used to advantageously manipulate the stomal microbial environment in future     clinical trials.      Commensal skin bacteria colonize all stomas. Colonization does not necessarily result in     infection. Over time, the presence of this skin penetrating foreign object (implant) will     cause measurable changes in the bacterial population (microbiota) at and around the POP exit     site. It is anticipated that the evolving microbiota, in concert with measurable changes in     the local and systemic cytokine responses, will reveal patterns associated with     mutualistic-commensal bacteria and/or pathogenic bacteria related to the stages of chronic     wound healing. These patterns could be used to determine the presence of a stable uninfected     stoma or the progression of a stomal infection. Hopefully, this information will allow timely     intervention to prevent infection, i.e. by detecting early stages of infection or discerning     common patterns of stable mutualistic-commensal bacterial strains, effective intervention     protocols (antibiotics, probiotics or manipulation of the stomal and skin microbiota) may be     developed to avoid patient morbidity and assure implant survival.   "
55099|NCT02564419|"     In this study, investigators will show proof-of-concept that brain signals can be used in     real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo     surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the     motor cortex. These electrodes implanted in the brain will enable bioelectrical data     recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data     will be        1. either processed in the Activa PC+S; or        2. off-loaded via the Nexus D communication device (Medtronic) to a computer.   "
55100|NCT02564406|"     Noninvasive ventilation represents the standard of care for patients with exacerbation of     chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe     forms of acute hypercapnic respiratory failure and patients must undergo endotracheal     intubation and invasive ventilation to restore adequate gas exchange. Under these     circumstances, patients may express a clear intention not to be intubated.The aim of this     study is to retrospectively assess efficacy and safety of noninvasive ventilation-     plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.   "
55101|NCT02564393|"     The study is defined in 3 stages of in vitro assays :      Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.      This is a transversal study in which we compare :        -  Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of          patients        -  Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and          blood of control subjects      Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify     receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent     transduction pathways calcium and PKC . It will be performed on control blood neutrophils.      Phase 3: Analysis of cell death ( NETose )      This is a transversal study that will analyze :      the mode of cell death of neutrophils purified blood and sputum of patients and control blood     neutrophils by flow cytometry and transmission electron microscopy .   "
55107|NCT02564315|"     Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking.     This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an     innovative multi-phase approach - - to test post-relapse treatments designed to assist     smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR)     treatments that are applied at two stages following relapse: 1) RR Preparation Phase     treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase     treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to     quit smoking will make an initial quit attempt in the Quit Phase (cessation medication +     counseling). Participants who relapse will be randomized to one of three RR Preparation Phase     treatments (Behavioral [Smoking] Reduction Counseling + the Nicotine Mini-Lozenge; Recycling     Counseling that encourages participants to quit again as soon as possible; and Preparation     Phase Control). RR Preparation Phase participants (other than controls) who elect to try a     new quit attempt will be randomized to one of four RR Cessation Phase treatments based on a     2X2 fully-crossed factorial design testing two factors: Supportive Counseling (vs. Brief     Information) and Skill Training (vs. Brief Information). All RR Cessation Phase participants     will receive 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine     mini-lozenge). The investigators hypothesize that RR Preparation Phase Reduction treatment     will significantly increase long-term abstinence rates relative to the Preparation Phase     Control condition.   "
55108|NCT02564302|"     This study aims to investigate the effect of MUSE (R) Headbands on patients with Atrial     Fibrillation who is awaiting pulmonary vein isolation ablation procedure. Patients are     randomized in 2 arms. The control arm will not be receiving the MUSE headband, whereas the     treatment group obtains a device.      Patients from both group will fill out a quality-of-life questionnaire at the time of     enrollment and 3 months post PVI. Results from both arms will be evaluated and ultimately the     effect of mindfulness using the headband will be evaluated in the aforementioned patient     population.   "
55109|NCT02564289|"     The current study proposes to investigate the effects of chronic snus use on the blood     vessels. Several cardiovascular endpoints are measured using various methods in healthy daily     snus users as well as in healthy matched controls.   "
55110|NCT02564276|"     To determine the difference in the proportion of hemipelves with successful detection of     Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging     vs blue dye) in women with endometrial cancer.   "
55112|NCT02564250|"     The purpose of this study is to study longitudinal changes in maternal metabolism and     pregnancy outcomes in obese pregnant women.   "
55113|NCT02564237|"     This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The     study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one     dosage (600 µg protein) in healthy adults 18 through 50 years of age.   "
55117|NCT02564185|"     According to the WHO, therapeutic education is intended to help patients acquire or maintain     the skills they need to optimally manage living with a chronic disease. Low back pain is     frequent and therapeutic education could be a promising option.      The purpose of the study is to evaluate the impact of a therapeutic education program for     patients suffering from low back pain.   "
55118|NCT02564172|"     Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has     devastating effects on patient's quality of life. Today, 30% of patients are refractory to     pain management and surgical procedure.      The neuropathic characteristics of the pain in these patients lead us to test the efficiency     of spinal cord stimulation at conus medullaris level.      In our published preliminary study involving 27 patients with refractory pudendal neuralgia,     we demonstrated that 74% of patients implanted with stimulation electrodes at the conus     medullaris responded to stimulation.      The primary objective of the present trial is to assess through a randomized, parallel group     design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar     surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time     in refractory pudendal neuralgia.   "
55119|NCT02564159|"     Malnutrition is a major risk factor for morbidity and mortality of patients managed in     intensive care unit. Early recognition and treatment of adult malnutrition are recommended in     acute care settings especially for patients requiring mechanical ventilation. Biochemical     indicators like serum concentrations of albumin and prealbumin (transthyretin) have a     tradition of being used as markers of nutritional status but remains influenced by     nonnutritional factors. A recent assessment of quadriceps muscle diameter with ultrasound     method has gained interest for screening and follow-up of muscle weakness at the bedside in     critically ill patients. The purpose of the study is to investigate the validity of     ultrasound as measurement tool for assessing malnutrition acquired in intensive care unit.   "
55202|NCT02563080|"     Severe pancreatitis induces more damage in the pancreas and might therefore result reduced     exocrine function leading to the insufficiency. The aim of this prospective study is to     investigate development of pancreatic exocrine insufficiency in patients recovering from     first attack of moderately severe or severe acute pancreatitis.   "
55121|NCT02564133|"     Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of     a hip prosthesis may be complicated by intracardiac embolization of various origin.      A patent foramen ovale exists in approximately one fifth of the population; it facilitates     the passage of embolus from the right heart to the left one and then especially to the     coronary vessels and to the brain.      The hypothesis supported in this research is that the prevalence of postoperative     complications, especially neurological ones, is increased after surgery for hip fracture when     patients have a patent foramen ovale.   "
55122|NCT02564120|"     NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate     cancer, who were enrolled from January 2011-June 2013. These patients were recruited     throughout North Carolina, and also in partnership with institutions across the country.     Patients enrolled before they start treatment, and are then followed prospectively through     treatment and then afterwards. This observational study collects information on quality of     life, cancer control, and health care received inclusive of treatment and management of     subsequent effects including complications and recurrence. The objective of this study is to     examine comparative outcomes among different modern prostate cancer treatment options in this     cohort of patients.   "
55123|NCT02564107|"     This study will evaluate the efficacy, safety, and effect on quality of life of oral     ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The     anticipated time on study treatment is 25 weeks, and the target sample size is 50     individuals.   "
55124|NCT02564094|"     This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with     subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or     solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size     is 60 individuals.   "
55125|NCT02564081|"     Recent research suggests that the skeletal muscles and the fibrous connective tissue form a     body-wide network of myofascial chains. A systematic analysis of dissection studies suggests     that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As     fascia can modify its stiffness, strain transmission along these meridians is supposable     (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to     the proper functioning of the movement system. However, despite solid evidence from in vitro     studies, scarce data is available concerning the in vivo behavior of the meridians. The     present study is conducted to resolve this research deficit and to elucidate whether     stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20)     participate in the randomized controlled trial. One group performs three 30 s bouts of static     stretching for the gastrocnemius and the hamstrings respectively. A control group remains     inactive for the same time. Participants of the third group perform 6x30 s bouts of static     stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post     intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM)     in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement     analysis system.   "
55126|NCT02564068|"     In human volunteers intranasal administration of oxytocin significantly increases     parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease     with high cardiovascular risk factors, yet this disease remains very poorly treated. This     proposal, based on the current literature and new basic science results detailed above on the     role of oxytocin in cardiovascular control, will test if oxytocin administration improves     adverse cardiovascular events during the recurrent nocturnal apneas in patients with OSA.     This project will lay the groundwork and provide preliminary data to obtain NIH funding to     test this important hypotheses more thoroughly and in larger clinical trials.      This study will explore if intranasal oxytocin has any positive cardiovascular benefits in     patients with sleep apnea.   "
55208|NCT02563002|"     In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly     assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of     care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The     primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS)     compared to current SOC chemotherapy.   "
55127|NCT02564055|"     This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and     1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the     topical treatment in adolescent and adult subjects with atopic dermatitis. Results from this     study will be considered when selecting the most appropriate concentration of GSK2894512     cream and application frequency in future clinical studies. This is a multicenter (United     States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,     6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic     dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream     will be equally randomized and evaluated following application to all atopic dermatitis     lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for     12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks     double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject     participation will be approximately 16 to 20 weeks. Approximately 270 adolescent and adult     males and females subjects with atopic dermatitis will be screened in order to have at least     228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately     204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to     achieve at least 24 evaluable Japanese subjects.   "
55128|NCT02564042|"     This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and     1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the     topical treatment in subjects with plaque psoriasis. Results from this study will be     considered when selecting the most appropriate concentration of GSK2894512 cream and dosing     frequency in future clinical safety and efficacy studies. This is a multicenter (United     States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,     6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and     1%) and a vehicle control cream will be equally randomized and evaluated following     application to all psoriasis lesions (except on the scalp) once daily (evening) or twice     daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks     screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total     duration of subject participation will be approximately 16 to 20 weeks. Approximately 270     adult males and females subjects with plaque psoriasis will be screened in order to have at     least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and     approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in     Japan to achieve at least 24 evaluable Japanese subjects.   "
55129|NCT02564029|"     PF-06372865 in subjects with photosensitive epilepsy   "
55131|NCT02564003|"     The pharmacokinetics of oxycodone is well characterized in children older than six months of     age. However, only one study has been published with children younger than six months,     concluding that unexplained inter-individual variability is pronounced in the youngest     children. The aim of the current study was to quantify oxycodone pharmacokinetics in children     ranging from preterm newborn infants to children up to two years of age.   "
55132|NCT02563990|"     This is a prospective, randomized, single-blinded human clinical trial that will examine how     injection pressure influences the spread of a given volume of injectate in the adductor     canal, during adductor canal nerve block.   "
55133|NCT02563977|"     The purpose of this study was to perform an evaluation of the structural changes in the     abdominal wall after harvesting a DIEP flap in breast reconstruction.      15 women undergoing secondary, unilateral breast reconstruction were recruited to the study     and underwent a 2 year postoperative CT scan of the abdomen (without contrast).      Structural changes were assessed by comparing the abdominal CT scans performed prior to     surgery with the 2 year postoperative CT scans.   "
55134|NCT02563964|"     Myocardial infarction (MI) frequently recurs after non-ST elevation MI (NSTEMI) that may be     related to insufficient vulnerable plaque identification using invasive coronary angiography.     Furthermore, the natural behaviour of vulnerable plaques in NSTEMI over time and their     relation with biomarkers need further exploration. More accurate identification and assessing     long-term behaviour of vulnerable plaques may improve therapeutic strategies and clinical     outcome. The investigators hypothesize that fully integrated 18Fluoride Sodium-Fluoride     (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance imaging (PET/CMR) increases     the ability to detect vulnerable plaques as compared to coronary angiography.      This prospective study in 33 consecutive patients with NSTEMI aims to:        1. Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive          coronary angiography,        2. Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with          myocardial infarction using CMR, both at baseline and during follow-up,        3. Examine systemic arterial 18F-NaF-uptake using PET/CMR and their relation with systemic          events (cerebrovascular accidents, transient ischemic attacks, or peripheral arterial          disease), and        4. Examine the relation between vulnerable plaques and plasma biomarkers.   "
55135|NCT02563951|"     The purpose of this study is to examine the pharmacokinetics (PK), safety and tolerability of     3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS)     as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.   "
55136|NCT02563938|"     This first-in-human study will evaluate the safety and tolerability of single doses of AK001     across a range of potentially active doses. Early signals of pharmacodynamic activity will     also be evaluated.   "
55137|NCT02563925|"     The purpose of this study is to see if the combination of tremelimumab with brain radiation     therapy can help treat this type of breast cancer that has spread to the brain.   "
55206|NCT02563028|"     Spine surgery in the prone position (which involves lying face down) is associated with     various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent     blindness. Known risk factors include low blood count (anemia) and long surgical times in the     prone position under general anesthesia. While blindness is a rare outcome of this surgery,     it is devastating and incompletely prevented by controlling known risk factors. Thus,     improved monitoring and detection of visual injury during surgery is necessary. The purpose     of this study is to determine whether a novel, non-invasive monitoring device can reliably     record visual responses during spine surgery. The first phase of this study is completed and     involved patients undergoing microdiscectomy surgery. The second phase of this study involves     patients undergoing single-level lumbar spine decompression/fusion surgery.   "
55138|NCT02563912|"     Dosage errors are common in the stressful situation of a pediatric resuscitation. In addition     to that, studies have reported that delays to provide medication is associated to worst     survival rate for very sick children. To minimize delays and error, the investigators     recently published a resuscitation handbook who provides drug dosages for each weight for     children thus eliminating the need for dosage calculation. Once the weight of the patient is     known, the physicians only have to open the book at the page corresponding to the weight and     all the medications with their calculated dosage are provided. The primary goal of this study     is to evaluate the number of dosage error during simulated pediatric resuscitation comparing     residents using the handbook vs. utilisation of a chart providing non-calculated dosage. This     will be an experimental crossover trial among 40 residents performing four simulated     case-scenarios in a high-fidelity simulation lab.   "
55139|NCT02563899|"     This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo     controlled study to assess the pharmacokinetic parameters, safety, tolerability, and clinical     effect of topically applied umeclidinium following once daily topical administration to     axilla for 14 days in subjects with primary axillary hyperhidrosis. This study will determine     whether topically applied umeclidinium can decrease hyperhidrosis without systemic     anticholinergic effects (ie. in the range or lower to those obtained after inhaled route) at     the highest possible concentration.      Subjects will be dosed by site staff each night immediately before bedtime for 14 days.     Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS)     measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic     sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of     the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately 24     subjects.   "
55140|NCT02563886|"     The purpose of this study is to determine whether intensive, focused training of the affected     upper extremity after stroke results in long-term functional gains in moderately-to-severely     paralyzed patients, more than 6 months after their vascular accident. During the course of     therapy, user's attempts to move and complete exercises are assisted by neuromuscular     electrical stimulation.   "
55141|NCT02563873|"     The investigators are examining the relationship between heart rate and heart contraction in     patients with heart failure and pacemakers, aiming to improve quality of life.   "
55142|NCT02563860|"     This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.   "
55143|NCT02563847|"     With this study the investigators investigate the effects of amino acids (tryptophan in two     different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety     mechanisms.   "
55144|NCT02563834|"     Studies of myocardial fuel selection using a novel palmitate-based PET probe   "
55145|NCT02563821|"     Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural     Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via     Continuous Epidural Infusion (CEI).      Purpose : However, the superiority of PIEB compared to CEI has not been investigated for     third trimester voluntary termination of pregnancy.      We hypothesized that PIEB administration would result in a better degree of satisfaction of     the patients compared with CEI for third trimester legally induced abortion analgesia.   "
78392|NCT02259803|"     Study to investigate the relative bioavailability of fixed-dose combination tablet vs.      mono-components of telmisartan and amlodipine   "
55146|NCT02563808|"     The purpose of this study is to investigate the impact of incorporating anticipated regret      into standard patient decision aids. Participants in the Wharton Behavioral Lab will be     administered a standard patient decision aid and an anticipated regret augmented decision     aid. Participants will complete a computerized survey about their experiences with each     version, and their answers will be assessed for potential differences associated with the     incorporation of Anticipated Regret.   "
55147|NCT02563795|"     Anesthesia for cesarean section requires special importance because it may affect both mother     and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary     objective during anesthesia. Even though many factors influence sensory nerve block for     surgical anesthesia, local anesthetic dose is the main determinant. Another factor that     influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement     of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces,     so the local anesthetic requirement also reduces. Many investigators recommend lower dose of     local anesthetic in obese patients due to reduced requirement There are many studies about     dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have     designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose     plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for     cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in     obese patients while avoiding maternal hypotension.   "
55148|NCT02563782|"     To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection     prophylaxis prior to and/or following transplant of MA09-hRPE cells.   "
55149|NCT02563769|"     The main purpose of this study is to determine if it is safe to use the study drug,     clavulanic acid, in combination with cocaine. In this study, subjects will receive     intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid     is being studied so future studies can be done to find out if this drug is helpful in     treating cocaine dependence. Currently, there is no available medication treatment for     cocaine dependence.   "
55150|NCT02563756|"     Patients with medial gonarthritis are randomised to a unicompartmental or a total knee     replacement.      Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by     CT Secondary aims: functional tests, gait analysis, health related quality of life and     patient related outcome.   "
55243|NCT02562547|"     This is a retrospective data-only study following the phased introduction of the HEM-AVERT®     Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on     the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in     labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and to     determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean     Section during labor and delivery.   "
55244|NCT02562534|"     The aim is to create a database including recordings of ECG data recorded in an MRI     acquisition   "
55151|NCT02563743|"     Purpose      Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden,     resulting in suffering for the individual and financial costs for the employer as well as for     society at large. Studies on interventions that address stress and mental ill-health and that     focus on sick leave and return to work (RTW) show little or no effect of commonly used     methods such as medication or psychological approaches. Furthermore, these interventions     often focus on the individual's symptoms without considering their work situation. The     occupational health services (OHS) has knowledge of the employee's work environment and can     offer treatment facilitating the employee's RTW and improving the employee's work ability     while taking into account both the individual and the work situation. The intervention in the     current study will be performed at the OHS.      The study aim is two-fold: first, an intervention that addresses both individual and     workplace related aspects among employees with work-related CMD:s and/or stress related     symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on     sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence     to the intended treatment and associations with the outcome of the intervention will be     assessed.   "
55152|NCT02563730|"     A multicenter, multinational, prospective study to clarify, whether the addition of     cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients     with suspected Idiopathic Interstitial Pneumonia   "
55153|NCT02563717|"     Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with     new system (low imposed work of breathing and prongs) reduce the frequency of delivery room     intubations compared to standard treatment with T-piece resuscitator system (high imposed     work of breathing and face mask)?      Trial summary: This is a randomised controlled trial of delivery room intubation rates     comparing a new system and T-piece resuscitation system for initial stabilisation of infants     born <28 weeks.   "
55154|NCT02563704|"     The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate     with three quinine regimens in the treatment of severe malaria in children at the Ebolowa     Regional Hospital located in the South region of Cameroon   "
55155|NCT02563691|"     This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in     conjunction with hormone therapy for patients with metastatic prostate cancer where there are     a limited number of metastatic tumours.   "
55156|NCT02563678|"     In this small pilot study, participants (patients and healthy volunteers) will have blood     drawn before and after the study intervention (hyperbaric chamber session or normal pressure     oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine     analysis.   "
55157|NCT02563665|"     All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients     with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at     the dialysis unit of ILBS.   "
55158|NCT02563652|"     Patients undergoing major surgery are exposed to extensive damage of tissues, which induces     widespread activation of the inflammatory system, called 'systemic inflammatory response     syndrome' (SIRS).This activation of the inflammatory system may induce instability of the     heart and respiration in the postoperative period. The degree of physiologic response to     postoperative SIRS as well as the degree of postoperative pain differ between patients.     Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia     care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients     need to stay in a PACU after major surgery has not been extensively studied, and more     appropriate tools for prediction of length of stay are needed.      The main aim of this study is to assess whether clinical observations, inflammatory     biomarkers or genetic markers may aid in the prediction of physiological instability and/or     pain after major surgery. Such predictors would help clinicians planning the length of     PACU-stays.   "
55159|NCT02563639|"     Objective of the registry is to assess the use of antithrombotic therapies and adherence to     guidelines in patients with non-valvular atrial fibrillation.   "
55161|NCT02563613|"     In recent years, Hong Kong is undergoing rapid changes together with macro social and     economic trends. The increasingly complex and diverse family structure is leading to a major     concern in the well-being of families, including their health, happiness and harmony (3Hs).     Family life and health education should be strengthened to meet the increasing needs of     healthy lifestyle promotion. In light of these concerns, the Happy Family Kitchen Movement     (HFKM) project, with a focus on FAMILY Holistic Health, will be conducted at territory-wide     level in Hong Kong. HFKM is a community-based research project to develop, implement and     evaluate a community-based family intervention program for improving family well-being. It is     expected that participants of the community-based family interventions will gain knowledge on     family holistic health and in turn promote a healthy lifestyle for 3Hs.   "
55162|NCT02563600|"     Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be     randomly divided into three groups:        -  a group that gets a telephone call before their invitation letter is sent.        -  a group that gets a telephone call after their invitation letter is sent.        -  a group that does not receive a telephone call.      The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the     patient of their appointment time, it will outline what the treatment involves and highlight     the potential benefits and drawbacks, and allow the patient to ask questions about the     treatment.   "
55163|NCT02563587|"     The purpose of this study is to determine the efficacy of laughter therapy in children to     improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital     stay.   "
55219|NCT02562859|"     The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the     blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given     as an oral suspension under fasted conditions as well as a tablet formulation under fasted     and fed conditions, in male healthy subjects.      Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral     suspension under fasted conditions as well as a tablet formulation under fasted and fed     conditions, will be assessed.      Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an     oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be     separated by a wash-out period of at least 6 days.   "
55164|NCT02563574|"     This study is being done to learn about the interaction of alcohol consumption and HIV on     brain function. The proposed study will have two broad objectives. The first is to     incorporate functional neuroimaging (FMRI) approaches, along with additional Magnetic     Resonance Spectroscopy (MRS) methods that will enable a delineation in both functional and     cerebral metabolic disturbances affecting specific functional brain systems that are     associated with the interaction of ethanol (ETOH) consumption on Human Immunodeficiency Virus     (HIV)-associated brain dysfunction. Recent data indicate that HIV infected patients with     heavy ETOH consumption have FMRI abnormalities and exhibit alterations on other neuroimaging     measures compared to moderate drinkers and people who do not drink at all. The second     objective is to examine the extent to which reductions in ETOH consumption among heavy     drinkers with HIV infection result from a motivational intervention. The findings from this     study will provide important information on how heavy ETOH and HIV interact to affect the     brain functional responsiveness, and the extent of improvement that might be gained by     reducing heavy ETOH use.   "
55165|NCT02563561|"     This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study     of apaziquone in patients with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter,     all of which must have been fully resected at TURBT.      In addition to Screening, patients will undergo an assessment of urothelial carcinoma of the     bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.      Following TURBT on Day 1, eligible patients will be randomized to one of three treatment arms     in a 1:1:1 ratio:      Arm 1 : One dose of Apaziquone      Arm 2 : Two Doses of Apaziquone      Arm 3 : Placebo      Primary endpoint is to evaluate the Time to Recurrence with either a one instillation of 4 mg     apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following     TURBT in patients with non-muscle invasive bladder cancer (NMIBC) who receive transurethral     resection bladder tumor (TURBT).   "
55166|NCT02563548|"     This is a phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in     hyaluronan-high (HA-high) subjects with relapsed/refractory Non-Small Cell Lung Cancer     (NSCLC) and HA-high subjects with relapsed/refractory gastric adenocarcinoma.   "
55167|NCT02563535|"     The aim of this study is to evaluate the potential advantage in terms of late lumen loss     reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in     the treatment of below-the-knee disease in patients with critical limb ischemia.   "
55168|NCT02563522|"     This study will assess the safety and efficacy of using gene therapy via intramuscular     injections of the calf for patients with chronic non-healing foot ulcers.   "
55169|NCT02563509|"     Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients, so     the viruses could not massively replicate when HAART was discontinued, then make HIV     functional cure possible.   "
55170|NCT02563496|"     This is a prospective, open-label, multicenter, non-comparative, single arm study of     pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of     age. A total of 60 subjects will be enrolled. Potential subjects who are slide-positive for     P. vivax will be started by the site on chloroquine (CQ) per local/national guidelines. Sites     will have up to 48 hours to obtain consent. Once full consent is provided, all subjects will     be screened and, if eligible, receive Tafenoquine (TQ), given as a single dose on Day 1. All     study medication should be taken with food. After the treatment period, subjects will attend     up to 7 follow-up visits through Day 120 (Days 3, 8, 15, 29, 60, 90 and 120). The main cohort     will consist of subjects aged >=2 years to <16 years with no restriction on gender. Subjects     will be dosed according to four weight bands. Within the total of 60 enrolled pediatric     subjects, a second cohort of up to 6 infants aged >=6 months to <2 years (weighing >=5     kilogram [kg]) will be recruited following completion of a planned first interim analysis. An     interim analysis will be conducted once sufficient data from 16 subjects is available to     assess pharmacokinetic (PK) and safety parameters. If needed, a second interim analysis will     be conducted after a total of 32 subjects have enrolled. The primary objective of this PK     bridging study is to adequately characterize the systemic TQ exposure in the pediatric     population.   "
55171|NCT02563483|"     This study evaluates the effects of the practice of yoga in combination with compassion     meditation on the quality of life, attention, vitality and self-compassion of family     caregivers of patients with Alzheimer's disease.   "
55172|NCT02563470|"     In this retrospective registry trial, the investigators sought to assess the incidence and     predictors of cardiovascular and cerebrovascular complications as well as their derivatives     (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation     requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism)     in cohort of patients undergoing head and neck surgery.   "
55174|NCT02563444|"     The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the     positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by     comparing the path indicated by the ultrasound fusion (virtual line) and the path actually     obtained on the control CT scan (real line).      Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more     accurate, saving time and irradiation (not evaluated here).   "
55175|NCT02563431|"     About 70% of hemiplegic patients suffer from hemiplegic shoulder pain after stroke. This     common occurrence is a cause for concern in the rehabilitation setting as it leads to     impairment of functional outcomes induced by discomfort and delays in rehabilitation,     important psycho-emotional repercussions as there is a correlation between upper arm pain and     depression, a longer hospital stay. Poor management of hemiplegic shoulder pain can     ultimately give rise to type 1 complex regional pain syndrome (CRPS I). There is no     consensus on treatment, care pathways or useful devices for positioning acute stroke patients     in the literature. Our objective is to compare the effectiveness of a new positioning     procedure of the hemiplegic arm with conventional positioning (pillow and     shoulder-immobilisation sling) in acute stroke patients.      Patient's actions are focus in 4 points:        -  Positioning in bed, wheelchair and standing with specific materials (holds, sling in          external rotation and abduction)        -  Be careful of shoulder's coaptation in care and functional activities (toilet, dressing,          transfers)        -  A training of the patient and members of family on pathology, risk, use of material        -  Daily passive mobilisation of the upper member by a therapist.   "
55177|NCT02563405|"     Hypertension is one of the most common cardiovascular diseases, which is a major risk factor     for stroke and cardiovascular events. Accumulated data has shown that target-organ damage is     related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects     with essential hypertension. There are many studies about the effects of different kinds of     drugs on blood pressure, but the clinical researches about the impacts of antihypertensive     drugs on BPV are limited, and the conclusion is still controversial.      In addition, recent studies found that the occurrence and development of hypertension,     especially essential hypertension, are closely related with hyperuricemia. Serum UA is an     independently prognostic indicator for the development of hypertension. Some studies have     observed the effects of different kinds of antihypertensive drugs on uric acid level in     hypertensive patients. After adjustment, calcium channel blockers are associated with a lower     risk of incident gout among people with hypertension. However, the effects of alpha blockers     on uric acid in plasma are still not very clear.      Therefore, we performed this study to observe the different effects of alpha blocker and     calcium channel blocker on blood pressure variability and uric acid level in hypertensive     patients.   "
55178|NCT02563392|"     Hysterectomy is an effective treatment used as a first-line approach for uterine myomas.     Several others alternatives to hysterectomy have been developed in recent years for women     wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound.      Myomectomy, particularly through minimally invasive surgery, is currently considered the     conservative treatment of choice for patients wishing to preserve their fertility. However,     three important issues should be considered: the risk of intra- and postoperative bleeding,     the risk for recurring myomas, and the preservation of subsequent fertility.      Preventive uterine artery occlusion can be combined with laparoscopic myomectomy in order to     avoid bleeding and improve uterine suture. Another expected long-term benefit is the     improvement of treatment efficacy, leading to less symptoms and myomas recurrence. However,     the effect of uterine arteries occlusion on the ovarian reserve of women of childbearing age     has not yet been studied, which limits its clinical application.   "
55179|NCT02563379|"     The goals of our study are to determine a).the association between abnormal circadian BP and     the development of paroxysmal AF in hypertensive patients, b).at which level of TOD,     paroxysmal AF episodes are detected in hypertensive subjects, c).if there is any association     between systolic and/or diastolic BP levels with AF occurrence, d).whether the mean heart     rate during a 24-hr interval is associated with the development of paroxysmal AF, and finally     e).examine the relationship between a wide PP and asymptomatic AF episodes in patients with     HTN.   "
55180|NCT02563366|"     This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem     cells (BM-MSCs) can promote function recovery in patients with poor early graft function     after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney     transplant recipients with poor early graft function (with or without dialysis) post     transplant are equally randomized into MSCs group or control group. Patients in MSCs group     are administered MSCs treatment. Allogeneic BM-MSCs (1*10^6/kg) from third party are given     intravenously for four consecutive doses every week after enrollment. Patients in control     group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and     severe adverse events up to 12 months post enrollment are monitored.   "
55181|NCT02563353|"     Objective:      This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard     parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body     vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV     stimulates muscles and bones. A combined treatment might have synergistic or additive     beneficial effects on bone, reducing fracture risk making treatment more effective and     cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve     fracture risk even further.      If the results of this pilot study are promising then a strong case can be made for a large     multi-centre RCT using strong endpoints including fractures and falls.   "
55203|NCT02563067|"     This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared     with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA     2015) in each of the groups (patients with severe asthma and high eosinophil counts and all     patients with severe asthma)   "
55204|NCT02563054|"     This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus     5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with     advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at     least 6 weeks and continued up to disease progression, and the target sample size is 300     individuals.   "
55182|NCT02563340|"     This study is designed to investigate the efficacy and safety of allogeneic bone     marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection (cAMR)     after kidney transplantation. Chronic AMR is diagnosed according to Banff criteria 2013 based     on renal graft biopsy and donor specific antibodies (DSA) examination. cAMR patients are     assigned to MSCs group or control group. Patients in control group are prescribed to current     desensitization therapy including at least one of the following treatments: plasmapheresis     (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib, depending on individual     pathological and immunological features (eg. DSA type and titer) of each study subjects.     Patients in MSCs group receive additional BM-MSCs therapy besides desensitization treatments     as in control group. Allogeneic BM-MSCs (1*10^6/kg) are intravenously administered every two     weeks for four consecutive doses. All cAMR patients are followed up for one year. Renal     function, DSA level, pathological features, patient/graft survival, and severe adverse events     are monitored during the follow-up period. Immunological features of patients in both groups     are consecutively examined.   "
55228|NCT02562742|"     This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir,     SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the     safety and efficacy of SOF administered in combination with ribavirin under real world use in     Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and     treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to     evaluate the incidence of adverse drug reactions (ADRs) under real world settings.   "
55229|NCT02562729|"     The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1     radical hysterectomy in cervical cancer.   "
55183|NCT02563327|"     The Tuberculosis Trials Consortium (TBTC) phase 3 treatment trial, Study 31, will investigate     the efficacy and safety of daily rifapentine (1200 mg daily) with or without moxifloxacin as     part of multidrug treatment regimens for drug-sensitive pulmonary TB. The proposed study     (Study 31 PK/PD) will examine the population pharmacokinetics and pharmacodynamics (PK/PD) of     high-dose daily rifapentine with and without moxifloxacin given for 17 weeks. Two different     PK sampling procedures are required for the population PK/PD assessments involving     rifapentine and moxifloxacin: (1) intensive sampling of 6 samples/participant on one occasion     plus subsequent sparse sampling for a subset of Study 31 participants who are invited to     co-enroll in Study 31 PK/PD; and (2) sparse sampling of 2-3 samples/participant for all other     Study 31 trial participants (these data will be collected as part of the Study 31 treatment     protocol). Herein, we describe the PK sampling to be conducted among those Study 31     participants who are co-enrolled to Study 31 PK/PD (n=60). Intensive PK sampling is needed in     some participants to estimate the population PK model parameters with no bias and     satisfactory precision (relative standard error < 20%). PK and outcomes data from all     participants in Study 31 will be merged to build the population PK/PD models to evaluate     PK/PD parameters. Details regarding these planned analyses are also provided in this Study 31     PK/PD protocol.      Primary Objectives:        1. Characterize the population pharmacokinetics of rifapentine and 25-desacetyl          rifapentine, using sparse PK data from Study 31 and intensive PK data from Study 31          PK/PD. Using the population PK model, determine post-hoc Bayesian estimates of          individual-level PK parameters.        2. Examine the relationship between rifapentine PK parameters of interest and treatment          efficacy. PK parameters will include area under the concentration time curve (AUC0-24),          peak concentration (Cmax), time above the mean inhibitory concentration (MIC), and          AUC/MIC. The treatment outcome of interest will be time to culture conversion and time          to treatment failure or relapse.           Secondary Objectives:        3. Among the Study 31 participants in the lowest 10% for rifapentine AUC0-24, examine the          PK/PD effect on culture conversion of sputa after completion of 4 months of daily          rifapentine therapy.        4. Examine the relationship between safety outcomes (Grade 3 or higher adverse events) and          rifapentine PK parameters (AUC0-24, Cmax, AUC0-24/MIC and time above MIC).        5. Characterize the population PK of moxifloxacin, and then estimate moxifloxacin AUC0-24          and Cmax when moxifloxacin is administered with rifapentine given at a daily dose of          1200 mg.        6. Examine the relationships between moxifloxacin PK and treatment outcomes (as described          in objective 2 for rifapentine) and moxifloxacin PK and safety (as described in          objective 4 for rifapentine).      Design:      In Study 31 PK/PD, among 60 participants with tuberculosis enrolled in a rifapentine-based     treatment arm of Study 31, PK data will be collected on two occasions. At TBTC sites that     have the capacity to perform this activity, participants will have 6 scheduled PK samples per     participant collected to measure rifapentine (with or without moxifloxacin) concentrations     over approximately 24 hours. In addition among these 60 participants, 2 to 3 scheduled PK     samples will be obtained on a second late sampling at > 14 days after the first PK     sampling.   "
55184|NCT02563314|"     Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at     some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2     retention is believed to be reversal of preexisting regional hypoxic pulmonary     vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical     ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention     with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled     oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and     improve both urinary output and renal function.   "
55185|NCT02563301|"     Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is     maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a     potential solution. The relatively short radius of the blade curvature combined with the     internal arrangement of optimal components means that the glottis can be seen without the     need for alignment of the oral, pharyngeal and tracheal axes.      The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view     of the larynx in patients with limited neck movements, making intubation quicker, easier and     possibly safer.   "
55186|NCT02563288|"     Patients undergoing intracranial procedures may experience severe hypertension and     tachycardia due to intracranial hypertension and to increased release of adrenaline.     Preventing perioperative sympathetic activity is of great importance. A common technique is     using b-blockers like esmolol, which effectively block perioperative hemodynamic changes     during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a     component of a balanced anesthesia during neurosurgical procedures. This study aimed to     evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing     elective craniotomy with fast track neuroanesthesia.   "
55187|NCT02563275|"     The aim of this project is to investigate whether alterations in sensory-motor performances     during weightlessness are only of theoretical relevance, or indeed restrict the capacity of     the participants. To find out, volunteers will monitor a complex realistic process by     operation of buttons and switches in weightlessness. The task will mimic the control of     vehicles, research equipment and industrial processes. Effects of weightlessness will be     separated from effects induced by stress and those of motivation through evaluation of     cortisol and manipulation of motivation.   "
55188|NCT02563262|"     The scientific goal of this experiment is to evaluate the performances of our     three-dimensional digital model by comparing its prediction computed from underwater data to     posture observed during real weightlessness during parabolic flight.   "
55189|NCT02563249|"     If investigators know that the anticipatory mechanisms involved in precision grip take into     account the gravity, however it is unclear how they adapt to changes in the gravitational     level. The objectives of this study are to study and model the movement control and the     mechanisms underlying learning and adapting to the condition of weightlessness. Specifically,     i) investigators will determine if a change in the level of gravity is taken into account     when controlling grip force and ii) investigators will examine the effects of gravity change     on hand-eye coordination.   "
55205|NCT02563041|"     BACKGROUND: Central venous catheters (CVC) are the only option when hemodialysis is needed     for patients without definitive vascular access. However, CVC use is associated with     complications such as infection, thrombosis, and dysfunction, leading to higher mortality and     expenditures. The aim of this study was to compare the effectiveness of 30% trisodium citrate     (TSC30%) with heparin as CVC lock solution in preventing catheter-related bloodstream     infections (CRBSI) and dysfunction in hemodialysis patients. METHODS: Randomized,     double-blind controlled trial comparing the event-free survival of non-tunneled CVC locked     with heparin or TSC30% in adult hemodialysis patients.   "
55207|NCT02563015|"     One in four infants are born with low amounts of vitamin D stored in their body. This study     is designed to test whether improving vitamin D status quickly after birth helps infants to     build muscle and to normalize growth. This is important since the investigators have noticed     in previous work that infants with low vitamin D have higher body weight relative to body     length later on and that those who develop very good stores quickly have a leaner body type.     Therefore, in this study infants with low stores early after birth will be given either the     regular amount of supplementation or a higher amount to more rapidly build up the vitamin     stores in the body. Infants in both groups will be measured for muscle and fat mass at     standardized ages during the first year of life and into the toddler years. The information     will inform health care professionals and parents of the importance of establishing good     vitamin D stores early in life. Vitamin D supplementation is a modifiable factor that is     already recommended for all term born infants. Knowing how much is needed in infants born     with low stores has not been tested in a controlled manner in Canada.   "
55190|NCT02563236|"     During a space mission the crew has to perform a wide variety of tasks under different     acceleration conditions. For handling of displays and control items during a mission, the     astronaut's performance is strong depended on an intuitive usability. Currently investigators     are exploring and developing different Augmented Reality interfaces for the International     Standard Payload Rack (ISPR) Biolab that is installed in the International Space Station     (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect, view of a     physical, real-world environment whose elements are augmented by computer-generated sensory     input such as sound, video, graphics or GPS data. Using AR technologies provides     user-oriented support for working procedures in development, production, and operating of     complex technical products and systems. It is conceivable that in future manned missions such     interfaces will be applied to space operations, where the astronaut will handle virtual     information that enriches the physical reality. To improve the support for the operational     ground team and the space crew by performing service and maintenance tasks at the Columbus     space laboratory Biolab, investigators explore innovative tridimensional (3D) interaction     techniques that allow an intuitive way to interact with the virtual content. The developed AR     interfaces for the ISPR Biolab ought to offer support while handling standardize service and     maintenance procedures. This research is primarily focused on supporting the ground team     during their work at the engineering model of Biolab that is located in Cologne at the     Institute of Aerospace Medicine. Applying these interfaces subsequently to space operations     requires previous exploration regarding the influence of different acceleration conditions     that ought to be considered at the investigators' current stage of designing and development.     Thereby one important aspect is focused on the correct placement of virtual user interfaces     while interacting with it. To explore human adaption of handling and controlling virtual AR     interfaces, this experiment denotes a usability study that will supply findings about human     mental workload and sensorimotor coordination while performing the experimentation task under     different accelerations of gravity. The proposed experiment will supply essential information     about understanding the adequate quality characteristics concerning placement of virtual     interfaces in physical reality and identify disturbing factors while applying in hyper-g and     micro-g conditions.   "
55191|NCT02563223|"     In this project, investigators propose to study the jump in different reduced gravity fields     obtained during parabolic flights profiles but also during increased gravity fields obtained     during turns of the airplane or during the pull-up phase of the parabola. By means of a     pneumatic device, an additional pull-down force will be added to the vertical force caused by     the gravity field. By combining different levels of gravity to different levels of the added     pull-down force it will be possible to dissociate the respective contribution of the     otolithic and proprioceptive systems to the anticipatory landing response. To the     investigators' knowledge, only one study has modified the gravity field during a jump.     However, these authors did not add a pull-down force and only analyzed the vertical ground     reaction force.      A better knowledge of the sensory-motor control of the landing phase of a jump will also     increase the investigators' understanding of the physiopathology of joint instability.     Indeed, similarities could be found between the evolution of the motor response due to the     absence gravity during long-duration space flights and the pathological process of chronic     ankle and knee instability. The knowledge generated by this study will thus provide     invaluable information in the context of human performance and rehabilitation.   "
55192|NCT02563210|"     In preschool aged children, the most suitable techniques to assess airway obstruction is     debit interruption technic (Rint) and plethysmographic measure of specific airway resistance     (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung     tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to     be better for discriminating airway obstruction. These two techniques will be compared in     terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.   "
55193|NCT02563197|"     Study should show feasibility of the device for drug delivery into the lung independently of     the severity of impaired lung function.   "
55194|NCT02563184|"     To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent     influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of     GOLD Stage C and D COPD vs. those patients without COPD.   "
55195|NCT02563171|"     Our objective in this case-control intervention study, therefore, was to explore the effect     of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with     chronic periodontitis in order to determine the usefulness of vaspin and omentin as a     diagnostic and prognostic biomarker of periodontal disease.   "
55196|NCT02563158|"     The study aims to compare the perioperative and long-term outcomes of liver resection for     HBV-related HCC with versus without hepatic inflow occlusion.   "
55197|NCT02563145|"     The purpose of this study is to determine whether real-time fMRI feedback is effective in the     treatment of aggressive behavior problems in adolescents with high callous unemotional traits     when compared to treatment as usual.   "
55198|NCT02563132|"     Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain,     bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory     bowel disease patients. The study was designed to evaluate discomfort after the carbon     dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.   "
55199|NCT02563119|"     Studying obesity and metabolic syndrome attention is focused more and more on gut microbiota.     In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations     of gut microbiota, which seem to be favourable. In this study the investigators aim to     examine the effect of different bariatric procedures on composition of gut microbiota.   "
55200|NCT02563106|"     A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004     Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in     Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract     Infection (LRTI).   "
55201|NCT02563093|"     The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016     formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults     18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and     Fluzone High-Dose vaccines in adults ≥ 65 years of age.      Primary Objective:      - To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone     Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the     2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65     years of age.      Observational Objectives:        -  To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and          Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the          immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone          High-Dose vaccines in adults ≥ 65 years of age.        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone          Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the applicable          age group with the historical requirements of the Committee for Human Medicinal Products          (CHMP) Note for Guidance (NfG) Committee for Propriety Medicinal Products (CPMP) - CHMP          NfG CPMP/BWP/214/96.   "
55209|NCT02562989|"     The purpose of this 2-part open-label study is to investigate the safety and efficacy of     [18F]MK-6240 as a Positron Emission Tomography (PET) imaging agent for quantifying brain     burden of neurofibrillary tangle (NFT) pathology. Brain NFT deposition is a pathology finding     in Alzheimer's Disease (AD), and density of brain NFTs has been shown to correlate with     severity of cognitive impairment in AD. The objectives of the study include performing the     following with respect to [18F]MK-6240 administered as a PET imaging agent: assess safety and     tolerability; determine radiation safety profile; determine optimal imaging protocol     parameters for quantification of brain NFTs in AD; compare tracer binding in brain PET scans     from participants with AD of varying severity, participants with amnestic mild cognitive     impairment (MCI) and healthy elderly participants; and evaluate intra-subject test-retest     (T-RT) variability of tracer uptake in brain regions of interest. The primary efficacy     hypothesis is that the intra-subject T-RT variability in brain regions associated with NFT     deposition in AD is ≤10%.   "
55210|NCT02562976|"     The aim of the present study was to evaluate characteristics of background mucosa in early     gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.   "
55211|NCT02562963|"     Natural killer T (NKT) cells are a unique subset of lymphocytes that present a mixed T-NK     phenotype. Our hypothesis is that Natural killer T cells may decrease the tumor burden and     improve overall survival. The purpose of this study is to determine whether Natural killer T     (NKT) cells are effective and safe in the treatment of patients with unresectable advanced     solid tumor.   "
55212|NCT02562950|"     This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of     GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy     male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2     occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837,     after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).      Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with     midazolam in healthy male subjects will be evaluated.      A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.)     GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg     (500 mg b.i.d.) GLPG1837.   "
55213|NCT02562937|"     The primary purpose of the current study was to determine whether a text message intervention     would increase break frequency and length of break from sitting, time spent standing, and     time spent in light and moderate intensity physical activity in university students   "
55214|NCT02562924|"     This study will assess the effectiveness of MEDIHONEY® sinus rinses (alone or in combination     with intranasal corticosteroids) vs. intranasal corticosteroid sinus rinses on mucosal     healing and polyp recurrence in the post-operative period following functional endoscopic     sinus surgery.   "
55215|NCT02562911|"     In the general population, age of puberty, and age of menarche in girls, are closely     correlated with those of their mother. The severity of chronic disease has an impact on the     stature, the weight gain and the onset of puberty: age of menarche is even later that chronic     illness is serious. Cystic fibrosis is one of the major chronic diseases of children.      Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore     currently have a very specialized and early care. Older patients were diagnosed during     childhood. The optimization of the nutritional and respiratory management has allowed over     the past two decades a significant improvement in the survival of these patients. Most young     people reach adulthood, puberty and reproductive desire are a crucial issue in the care of     these young adults.      In literature, it is often noted an age of menarche delayed an average of 2 years compared to     the general population, but correlated with the age of menstruation from the mothers.      The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are     poorly known and there are few data on the characteristics of cycles. The menstrual     irregularity and amenorrhoea episodes concern nearly half of women.      On the pathophysiological level, studies in animals show that there is a direct effect of     CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and     reproductive capacity in mice.      The literature data on the pubertal development, fertility and hormonal profile of these     girls are for studies with low numbers and are very old. There is to date no French cohort     study on this topic.      The study is a multicenter cross-sectional descriptive study for pubertal and gynecological     characteristics in girls followed annually in the reference centers Cystic Fibrosis two     inter-region.   "
56377|NCT02547701|"     Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or     affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated     topically with P-3058 nail solution according to the appropriate treatment schedule.   "
55216|NCT02562898|"     Gemcitabine and nab-paclitaxel is a standard regimen (NCCN, Category 1) for patients with     metastatic pancreatic ductal adenocarcinoma (PDAC). However, further improvement in treatment     is needed. Increasingly, the nature of the immune infiltrate in PDAC appears to be tumor     promoting. In preclinical studies, ibrutinib treatment, presumably by reprogramming B cells,     results in increased CD8+ T cells to assist in tumor control. Preclinical studies of     ibrutinib plus gemcitabine show superior antitumor effects compared to gemcitabine alone in     both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered mouse     models. Thus, the investigators propose a clinical trial of ibrutinib plus the standard     gemcitabine based regimen of gemcitabine and nab-paclitaxel, evaluating safety, then efficacy     and including correlative studies.   "
55217|NCT02562885|"     Background: Close relationship exists between sleep slow wave (SSW) and the generation of     spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between     excitatory depolarization (Up-phase of the SSW) and inhibitory hyperpolarization     (Down-phase of the SSW). It has been shown experimentally that with increasing synchrony of     slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in     correspondence to the SSW Up-phase enhance the amplitude of the subsequent SSW. Conversely,     tones delivered at the SSW Downphase have a disruptive effect on the following SSW.      Participants: Patients with epilepsy and spike waves in NREM-sleep.      Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep by     acoustic pulses applied at the Up- or Down-phase of SSW.   "
55218|NCT02562872|"     The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265     including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.      The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).   "
55242|NCT02562560|"     The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in     assessing three episodic memory's abilities (mental simulation throught the future, and the     past, the learning of personnal actions i-e the enactment effect). Secondary goal is to     describe the neuronal substrates associated to the alteration of theses abilites in TGA.   "
55220|NCT02562846|"     It has been convincingly demonstrated that electroconvulsive therapy (ECT) works better and     sooner than antidepressants in the treatment of certain subtypes of depression. Given this     effectiveness, it would be unfortunate not to give ECT to patients with good response chances     as this could substantially shorten the length of a severe depressive episode. Instead of     going through all possible psychopharmacological treatment steps, ECT could be proposed much     earlier as a treatment option for those patients who might have good response chances. This     would be a great advantage for the severely depressed patient, with a decreased     disease-burden and hospitalization duration.      However, up to now, objective and reliable predictive factors for good ECT response have not     yet been established. Clinical characteristics such as psychomotor retardation, psychotic     features and age have often been used to predict the outcome of ECT, but there is too little     evidence to consider these as strong predictive factors.      The current project is designed to allow better prediction of ECT-response. The investgators     base their selection of predictors on clinical impression and previous research results. The     predictive capacity of psychomotor functioning, psychotic symptoms and several biomarkers     will be investigated. With these clinical and biological patient and depression     characteristics, the investigators aim to develop a decision making tool that will allow a     more accurate indication of ECT.      The investigators also investigate ways to predict whether or not a patient will have a good     response when treatment has already started, based on an early improvement of psychomotor     functioning.      Another subject of great importance is predicting and preventing side-effects. When patients     at risk for lasting cognitive side-effects can be identified early in the treatment course,     treatment can be adjusted to prevent persistence of memory problems. Therefore, the second     part of the study focuses on identifying people at risk for cognitive side effects early in     the treatment course.   "
55221|NCT02562833|"     The PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a     self-management and exercise program specific for elderly with knee osteoarthritis (OA), with     the goals of managing OA symptoms, improving physical fitness, and developing self-efficacy     and self-management of pathology.   "
55222|NCT02562820|"     Rett Syndrome (RTT) is a complex disorder resulting from mutations in a gene encoding the     MeCP2 protein. Currently, there are no methods to fix the abnormal gene, however, animal     studies suggest that the symptoms of RTT can be treated.      Ketamine is a sedative or anesthetic, depending on the dose. The drug is approved by the US     Food and Drug Administration (FDA) and is commonly used in children and adults. Animal     studies and case reports in humans suggest that ketamine may reduce the symptoms of Rett     syndrome. The purpose of this study is to determine the safety and efficacy of ketamine for     treating breathing and behavioral symptoms of RTT.   "
55223|NCT02562807|"     The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic     of TAS-303 in female patients with Stress Urinary Incontinence.   "
55224|NCT02562794|"     This study will use CBPR mixed methods (qualitative and quantitative data collection) to     conduct needs assessments and design and evaluate a core family-based intervention. Project     activities will emphasize capacity building in two refugee communities resettled in Greater     Boston—the Somali Bantu and the Bhutanese—actively engaging refugee community members,     community advisory boards, services providers, and other stakeholders. Specific Aims are to:     (1) deepen partnerships with the Somali Bantu and Bhutanese communities through     co-leadership, capacity-building, and knowledge sharing; (2) collect and apply qualitative     data to (a) prepare a needs assessment of mental health in children and adolescents, barriers     to care, and services preferences with each target refugee group; (b) develop mental     health/psychosocial assessments for refugee caregivers and children; (c) adapt the core     components of a family-based strengthening intervention for use with refugees; and (3)     conduct an 80-family pilot study to examine acceptability and sustainability of the     intervention. Key outcomes will be reduced mental health symptoms among children and     adolescents and improvement in caregiver-child relationships.   "
55275|NCT02562131|"     Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent     prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high     molecular sensitivity of PET in a single imaging session. The aim of this study is to     evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for     detection of recurrent prostate cancer.   "
56406|NCT02547324|"     This is a prospective, single-blinded, randomized-controlled study comparing a new method     (slump-sitting) with the conventional method (forward erect bending) of performing lumbar     spine flexion X-rays.   "
55225|NCT02562781|"     Patients undergoing vascular surgery are at a significantly high risk of perioperative     cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery.     This could be because of co-morbidities that are common in this patient group. Additionally,     smoking, which is common in this population, may be a contributing factor.      Oxygen therapy has been used for decades in order to reduce the risk of myocardial infarction     and stroke in patients undergoing vascular surgery and pre-existing co-morbidities in the     belief that increased inspired oxygen increases oxygen delivery to tissues, thereby reducing     the risk for hypoxia and cell death. However, several studies published recently have     questioned the routine use of high inspired oxygen concentration (hyperoxia) to improve     oxygen delivery, specifically in the neonatal period but possibly even following myocardial     infarction. This could be explained by the fact that increasing inspired concentrations of     oxygen cause vasoconstriction in cerebral and coronary arteries, thereby reducing blood flow.     Additionally, increased oxygen causes excessive production of reactive oxygen species (ROS),     and repercussion injury from oxidative stress. The latter can lead to apoptosis (cell death)     in myocardial or cerebral neurons. Despite the high risks of administering oxygen when not     needed, it is routinely used in hospitals all over the world without a doctors prescription.      This study aims to assess peri-operative complications up to 1 year following vascular     surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2     98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).   "
55226|NCT02562768|"     This two-part study will evaluate how safe LY3154207 is and the effects it has on the body.      Part A will include healthy participants. Each participant will receive daily doses of     LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day     stay in the clinical research unit (CRU) and follow-up.      Part B is contingent on the results of Part A. Part B will include participants with     Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for 14     days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and     follow-up.      Both Part A and Part B will require screening within 30 days prior to the start of the study.   "
55227|NCT02562755|"     This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based     immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with     sorafenib in patients with advanced hepatocellular carcinoma who have not received prior     systemic therapy.   "
55230|NCT02562716|"     This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and     oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and     paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients     with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as     fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and     paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill     more tumor cells. It is not yet known whether combination chemotherapy is more effective than     gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before     surgery in treating pancreatic cancer.   "
55231|NCT02562703|"     This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as     primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve     Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.   "
55232|NCT02562690|"     Impaired thrombotic status is associated with adverse cardiovascular events. Patients with     acute coronary syndrome (ACS) are at increased cardiovascular risk. The aim of the study is     to determine the usefulness of thrombotic status assessment in a large cohort of ACS     patients, managed with contemporary treatments, to identify patients at risk of thrombosis     and those at risk of bleeding complications.   "
55233|NCT02562677|"     This is a phase II, open-label clinical trial. This clinical trial has as primary objective     to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for     elderly patients with moderate / severe depressive episode.   "
55234|NCT02562664|"     Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a     prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria     and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically,     PCOS can identify during the early adolescence. Insulin resistance is a common finding in the     obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving     hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are     metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by     velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the     intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition     of its more common connection to obesity and insulin resistance allows for diagnosis of     related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary     syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene     treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular     randomized, double-blind, placebo-controlled trial . The first pharmacological approach to     induction of ovulation in women with PCOS is clomiphene citrate   "
55235|NCT02562651|"     The purpose of the study is to investigate the changes of myocardial biomechanics and     efficacy of doxycycline in patients with primary anterior STEMI.   "
56425|NCT02547077|"     The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during     repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure     with 5-0 fast absorbing gut.   "
55236|NCT02562638|"     Traditionally, patients are kept nil-per-os (NPO) or nil-by-mouth (NBM) prior to invasive     cardiac procedures. There exists neither clear evidence nor guidance about the benefits of     this.      The investigators aim to assess if there is a reduced incidence of vasovagal complications     (primary outcome) and the combined incidence of aspiration pneumonia, change in eGFR,     participant satisfaction if participants are not kept fasting.      This (pilot) randomised control trial will have an intervention arm allowing participants to     drink clear liquids freely up to 1 hour before the procedure versus keeping them     traditionally NPO.      240 patients will be randomised with 120 participants in each arm.   "
55237|NCT02562625|"     Around 13,000 participants are diagnosed with melanoma in the UK each year and that number is     growing quicker than any other cancer. About 20% of participants will see their cancer return     following their initial treatment and at present would survive a median time of 912 months.     In recent years, the development of new effective drugs has revolutionised the treatment of     advanced melanoma, However, response rates are still low and new therapeutic approaches are     needed.      This is a phase II study to look at the effectiveness and safety of the combination of a new     drug called pembrolizumab plus radiotherapy compared to pembrolizumab alone. The purpose of     this study is to see if the addition of radiotherapy to pembrolizumab is better than     pembrolizumab alone by measuring how long these treatments can control the growth of the     cancer. Also it will assess if by adding radiotherapy the investigators can see its effects     not only in the tumour that has had radiotherapy but also in other tumours in the rest of the     body.   "
55238|NCT02562612|"     The purpose of this study is to collect response and pharmacokinetic data on the oral     administration of a cocktail combination of 4 drugs being developed for the indication of     metastatic breast cancer.   "
55239|NCT02562599|"     The purpose of this study is to evaluate the efficacy and safety of raltitrexed and cisplatin     neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and cisplatin     in patients with locally advanced nasopharyngeal carcinoma.   "
55240|NCT02562586|"     The goal of this study was to compare early results of Total Hip Replacement (THR) in 2     groups of patients: with and without closed suction drainage (CSD). Patients were followed     for 3 months post operatively.   "
55241|NCT02562573|"     This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050     800 mg daily oral administration in type 2 diabetes patients with metabolic syndrome.      A total of 12 patients will initially be enrolled for study participation. A Data Safety     Monitoring Board (DSMB) will continuously review data obtained from the 12 patients. When the     12 patients have completed at least one month of study treatment, the DSMB will meet and     determine whether additional patients may be enrolled or the study should be stopped. If the     safety is deemed acceptable to continue with the study, the study will enroll a maximum of 36     patients.   "
55453|NCT02559778|"     A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of     using molecularly guided therapy in combination with standard therapy followed by maintenance     therapy with DFMO in subjects with newly diagnosed high risk neuroblastoma.   "
55246|NCT02562508|"     This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen     Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the     immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in     girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the     standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the     difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).   "
55247|NCT02562495|"     Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of     mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of     muscle loss. This is a serious pathology associated with high morbidity and mortality.      Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic     Resonance Imaging (MRI) are considered as gold standards to quantify and monitor changes in     muscle mass. But these tools are not adapted to ICU patients.      Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not     expose the patient to additional radiation.      The objective of this study is to evaluate the correlation between US and CT scan to measure     quadriceps muscle thickness of ICU patients.   "
55248|NCT02562482|"     This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the     safety and immunogenicity of a 2 injection vaccine Chikungunya virus (CHIKV) and virus like     particle vaccine (CHIKV VLP) in healthy adults.   "
55249|NCT02562469|"     A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD.     ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see:     www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e.,     sustained attention, working memory (WM), response inhibition, speed of information     processing, cognitive flexibility and control, multiple simultaneous attention, category     formation, and pattern recognition and inductive thinking).   "
55371|NCT02561000|"     The object of the study is to determine whether different doses of PZ-128, when added to     standard medical care in persons undergoing cardiac catheterization/percutaneous coronary     intervention, will increase the risk of bleeding.      A secondary objective is to determine whether patients treated with PZ-128 have fewer cardiac     events such as heart attack, bypass surgery or stroke compared with those persons treated     with the standard of care.   "
55250|NCT02562456|"     The aim of this randomized clinical trial study is to compare the longevity of ART using high     viscosity GIC and conventional treatment using composite resin in posterior primary teeth. As     secondary outcomes, cost-efficacy and patient's self-reported discomfort will also be tested.     Children aging between 3 to 6 years old presenting at least one occlusal and/or     occlusal-proximal cavity will be randomly assigned in two groups according to the dental     treatment - ART with high viscosity GIC (experimental group) or composite resin restoration     (control group) -, which will be performed at dental care trailer located in a Educational     Complex in Barueri/SP, Brazil. The unit of analysis for randomization will be the child. A     number of 240 teeth presenting occlusal cavities and 188 teeth presenting occlusal-proximal     cavities were set after sample size calculation. The groups will still be stratified     according to children's caries experience. The primary outcome will be the restorations'     longevity, which will be assessed after 6, 12, 18 and 24 months by two examiners through     clinical examination of treatment according to Frencken and Holmgren (2001) criteria for     occlusal cavities and Roeleveld et al. (2006) criteria for occlusal-proximal ones. The time     spent during the dental treatment and all materials used will be considered for estimating     the cost-efficacy of each treatment. The individual's discomfort will be also measured after     each dental procedure using the Facial Scale of Wong-Baker.   "
55252|NCT02562430|"     In summary, the proposed research is novel with respect to design, technology, and its     multi-level integration probing psychological and neurobiological constructs assumed to be     crucially implicated in placebo response and has significant clinical and research     implications for the future. Specifically, the future implications include: 1) identification     of biomarkers and biosignatures of placebo responders, 2) new possibilities to understanding     and manipulating the system, 3) possibly decreasing or eliminating a major confounder in     clinical trials and drug development, and 4) refining treatments with novel drugs that     decrease (in clinical trial) or increase (in clinical practice) the placebo response.   "
55253|NCT02562417|"     Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular     block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure     against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone     may impair the reversal effect of sugammadex. The objective of this randomised controlled     trial is to confirm in the clinical practice these preliminary results.   "
55254|NCT02562404|"     This study is an observational study designed to determine the extent of gastrointestinal     (GI) post-procedure complications after Radiofrequency Catheter Ablation (RFCA) for atrial     fibrillation (AF). This exploratory study will evaluate patient symptoms prior to the RFCA     procedure, at 1 month post RFCA procedure, and at 3 months post RFCA procedure, through the     administration of a questionnaire. The purpose of this study is to determine if vagus nerve     injury resulting from RFCA for AF increases the risk of post-procedure GI complications that     may present as temporary or permanent symptoms.   "
55255|NCT02562391|"     The aim of this study is to assess the effect of left atrial appendage excision on atrial     fibrillation recurrence and incidence of stroke in patients with persistent and long-standing     persistent atrial fibrillation undergoing surgical ablation.   "
55256|NCT02562378|"     The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1     and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously     treated with taxanes and trastuzumab-based therapy.      In addition, pharmacokinetic data on the combination of T-DM1 and lyposomal doxorubicin will     be obtained.   "
55257|NCT02562365|"     Ovarian cancer was mostly diagnosed at late stage (III/IV) with high rate of recurrence after     first line of therapy by optimal cytoreductive sugery and 6-8cycle of TP chemotherapy. We     developed an adjuvant chemotherapy of three steps (ACTS). It is adding CTX+VP-16(second     step)6cycle and CTX+CBP(third steps) to firstline chemotherapy (first step). The aim of this     study is to verify the effectivity and safety of ACTS.   "
56015|NCT02552420|"     The purpose of this study is to determine the effectiveness of infrared thermal imaging in     adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).   "
55258|NCT02562352|"     In an aging population, most seniors suffer from multiple chronic conditions. When the number     of medications taken is ≥5 (polypharmacy), the burden of taking so many together can do more     harm than good. This study will test a program focused on medication reduction involving     patient, pharmacist and physician using current technology aimed at reducing the harms of     polypharmacy. Reducing the risk of adverse effects from drugs or the interactions between     them involves prioritizing the most important ones according to the patient's preference and     stopping those which may no longer be necessary. Reducing the dose also reduces the risk of     drug side effects. Patients, aged over 69 years taking ≥5 medications, will randomly receive     the program immediately or at 6 months. The program involves information gathering from the     patient, medication review with the pharmacist and then a consultation with the family doctor     focused on discontinuing/reducing the dose of medications where possible using a 'pause and     monitor' framework to assess the need for restart. An electronic program that detects drug     adverse effects and flags potentially inappropriate medications will be integrated into a     clinical pathway incorporating monitoring and follow up systems. This study will examine     effects on patient and health relevant outcome measures as well as patients' and clinicians'     experiences of the program. The results will be used to determine whether this system can be     implemented as part of routine preventative care in older adults.   "
55259|NCT02562339|"     This is a prospective study that will examine psychosocial improvements among CF adolescents     and caregivers going through the Stress Management and Resiliency Training - Relaxation     Response Resiliency Program (SMART-3RP).   "
55372|NCT02560974|"     This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation     alone in chemotherapy-naive participants who have undergone potentially curative resection     for gastric cancer. Participants will be randomized to either the chemotherapy arm or the     observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared     (mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin     will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles.     The anticipated time on study treatment in 6 months and the target sample size is 1024     individuals.   "
55260|NCT02562326|"     This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an     individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes     mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro     compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of     multiple daily dose administrations for 14 days. Each subject will be randomised to a     sequence of two treatments, either BioChaperone insulin lispro-Humalog® or     Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an     individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be     determined at the screening visit. During the outpatient phase the subjects will keep their     basal insulin constant (except changes for safety reason). They will self-measure blood     glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per     outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2     hours post-prandial and at bedtime).   "
55261|NCT02562313|"     This study is constituted of 2 parts:      Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will     participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion     (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company).     Each treatment period consists of 10 treatment days under free living conditions (e.g. home /     workplace) and under standardised conditions at the clinic. Various assessments for     pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are     performed on selected days, including:        -  Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the          post-prandial glucose response for 6 hours after individualized standard meal (fixed          nutrient ratio) ingestion and bolus administration via CSII.        -  Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode          (i.e. neither subjects nor the investigators are aware of the sensor glucose values).        -  Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the          Investigational Medicinal Products (IMP) during the outpatient periods.      Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period     cross-over study aiming at comparing the performance of BC Lispro and Humalog after a     prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and     Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump     compatibility and safety will be analyzed.      Each period will include a mixed meal tolerance test with a CSII device and a mixed meal     tolerance test with the same dose of insulin administered with a syringe.   "
55262|NCT02562300|"     Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality     worldwide and that is according to the estimates of the World Health Organization in 1998.     Average blood loss during delivery progressively increases with the type of delivery, vaginal     delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood.      A reduction of operative blood loss at cesarean section has a great benefit to the patients     in terms of decreased postoperative morbidity and a decrease in risks associated with blood     transfusions. The routine use of oxytocin is associated with a significant reduction in the     occurrence of postpartum hemorrhage.      Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by     need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of     cesarean births.      Although many delivery units use oxytocin as the first line agent to prevent uterine atony at     cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage     especially in compromised patients with preeclampsia, cardiac disease or prolonged labor.     Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has     negative inotropic, antiplatelet and antidiuretic effects.      Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective     myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.      Misoprostol administration, either by oral or rectal route, has been shown to be effective in     prevention of postpartum haemorrhage and is considered as an effective alternative to other     conventional oxytocics especially in developing countries as it is cheap and thermostable.      Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual     administration was higher than those after oral or vaginal administration.      A few studies are now available for the use of sublingual misoprostol in the prevention of     postpartum haemorrhage following vaginal delivery and have reported it as an effective and     convenient route of administration.      However, none of the studies conducted so far have evaluated the response of sublingual     misoprostol for prevention of postpartum haemorrhage during cesarean section.   "
55271|NCT02562183|"     In order to reevaluate safety and efficacy of human urinary kallikrein in treating acute     cerebral infarction ,a multi-center, open label , single group study was designed. Expect to     enroll 60 sites and 2186 subjects. Subjects will receive kallikrein treatment according to     real clinical practice (suggest above 14days treatment) and 90 days follow up   "
55263|NCT02562287|"     The clinical use of clozapine has been an unequivocal advance in the treatment of     schizophrenia, a chronic and severe mental illness. A wealth of clinical data demonstrates it     offers enhanced efficacy on both positive and negative symptomatology, improving cognition,     functioning and quality of life. It is also associated with improved compliance and a     continued efficacy in long-term treatment that can be translated into a reduction of     suicidality and all-cause mortality. Because of preclinical evidence that it modulates     neuroplasticity and prefrontal cortex connectivity, clozapine may be an interesting strategy     for further severe psychotic illnesses. Nevertheless, even considering the growing use of     other atypical antipsychotics in the management of bipolar disorder, a role for clozapine has     been poorly defined. The clinical evidence-base for its use in this condition is largely     based on uncontrolled naturalistic trials and retrospective studies and chart reviews.     Several of these have supported clozapine's efficacy in treatment-resistant bipolar disorder.     Possibly because of clozapine's profile of adverse effects and lack of interest from     pharmaceutical companies, only two randomized trials have examined its effectiveness. Both     suggest clinically relevant antimanic and mood-stabilizing properties. Therefore, the primary     objective of this trial is to determine the effectiveness of clozapine for     treatment-resistant bipolar disorder. Secondary objectives include examining the effects of     treatment with clozapine on cognition and functioning of patients with bipolar disorder.     Tolerability and safety of long-term clozapine use will also be examined. To that end, the     investigators will conduct a clinical trial with 54 patients with a history of treatment     resistance. Patients will be randomized to either open-label treatment with clozapine, in     combination with lithium or valproate, or open-label treatment with an atypical antipsychotic     with consistent evidence of efficacy in the treatment of bipolar disorder (olanzapine,     quetiapine or risperidone), also in combination with lithium or valproate. Patients will be     followed for one-year and time to all-cause treatment failure will be the primary outcome     measure. It is the belief of the investigators that this study will generate meaningful     clinical data of tremendous importance to validate clozapine as a legitimate treatment option     for treatment-resistant bipolar disorder.   "
55264|NCT02562274|"     This study the investigators aimed to determine the effect of the herbal porridge containing     the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone     formation markers of menopausal women. Forty-five participants were randomly assigned to     receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.   "
55307|NCT02561715|"     Anosognosia is a recognised condition for people with Parkinson's, and is the result of     physiological damage on brain structure.      Surgical Parkinson Disease Nurse Specialists have noticed that when reviewing the pre-surgery     videos 12 months post-DBS, patients have forgotten and are shocked at how bad their symptoms     were prior to surgery (personal communication), which may not be reflected in the change in     QoL reported.      This lack of awareness, while possibly helpful in everyday life, may lead to effective     treatments looking ineffective, or the benefits in QoL of effective treatment appearing     reduced. This confound may not only reduce the apparent effectiveness but also the related     cost-effectiveness of treatment. As cost-effectiveness is determined by both size and     longevity of an effect, current methods of capturing these data may be suboptimal.   "
56542|NCT02545556|"     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional     therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.   "
55265|NCT02562261|"     Activation of blood platelets is a typical finding in patients with systemic inflammation and     sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation     while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial     cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the     exact effects of bacterial products on platelet function have not been found to be consistent     and may vary according to the species, the timing of the study, and the pathogenesis of     sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation     among patients with sepsis compared to healthy controls. Defining platelet's behaviour during     sepsis is particularly important in view of recent findings revealing potential association     between antiplatelet therapy and reduction in short term mortality, incidence of acute lung     injury and intensive care unit admission in critically ill patients.This study aims to     measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay,     in platelet reactivity units (PRU)- along different stages of sepsis, including     bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow     up of patients going along different stages will also be performed. At the end of this study     analysis of clinical and laboratory findings in correlation with platelet reactivity will be     performed to assess platelet aggregation during sepsis.   "
55266|NCT02562248|"     Inattentive behaviors are a common childhood condition that presents to the general     pediatrician. While some of these behaviors are expected during childhood, others need     work-up to ensure optimal functioning at home and school. A number of these children     ultimately go on to have a mental health conditions, such as ADHD. However, inattentive     symptoms represent a broad spectrum of potential behavioral and mental health conditions,     such as pediatric anxiety which can masquerade as or co-exist with ADHD. Treatment is quite     different and general pediatricians must have ways to facilitate the accurate identification     of children needing further work-up and referral. Health information technology can greatly     improve pediatricians' ability to identify and refer children with inattentive symptoms for     further work-up. This study represents initial work to revise an existing computer decision     support system's module for identification of ADHD to include screening questions and prompts     for anxiety.   "
55267|NCT02562235|"     This study is designed to evaluate the safety, tolerability, pharmacodynamics and     pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg,     1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary     arterial hypertension (PAH) group 1. The study consists of two phases: titration phase up to     8 weeks and a maintenance phase up to 16 weeks.   "
55268|NCT02562222|"     The aim of this study is to establish an optimized protocol of tDCS that normalize the lack     of habituation and efficiency of inhibitory cortical circuits in migraine patients and     determine tDCS polarity and the best cortical areas to stimulate which could normalize the     lack of habituation and efficiency of inhibitory cortical circuits. For this, migraineurs     volunteers will undergo to some tDCS protocols or sham tDCS.   "
55269|NCT02562209|"     This study evaluates the effects High Protein Atkin's Complete (lacto) VEgetaRian Diet     (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian     Indians subjects living in north India.   "
55270|NCT02562196|"     The aim of this study is to evaluate an optimized protocol of tDCS that normalize the lack of     habituation and efficiency of inhibitory cortical circuits in migraine patients. For this     purpose, migraineurs volunteers will undergo to optimized tDCS protocol or sham tDCS.   "
55802|NCT02555215|"     The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects     who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate     the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS)     outcomes in subjects who completed Study 109MS202 (NCT02410200).   "
55272|NCT02562170|"     Randomized controlled trial to look at early complications, cosmetic outcome, patient     satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate     implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a     mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer     centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.   "
55273|NCT02562157|"     Achieving gastro-jejunal or duodenal anastomosis (GJA ) by exclusive endoscopically is a real     goal for many years in the development and research of the transluminal endoscopic surgery     (N.O.T.E.S). Endoscopic treatment, including palliative antro duodenal stenosis by metallic     stent, although minimally invasive, causes problems in long-term secondary obstruction and     migration. Surgical treatment of these strictures is associated with significant morbidity     and mortality . The complication rate and severity of post-operative surgery after gastric     bypass Roux-en-Y anastomosis or gastroduodenal fistulas remain close to 5% with a mortality     of 1%. After 3 years of experimental research on porcine model, our team has developed a     procedure of gastro duodenal anastomosis using transgastric endoscopic minimally invasive     surgical technique (or NOTES) - LBA UMRT24 CERC laboratory , Aix-Marseille University ,     Faculty of Medicine North, with the aim to offer a credible alternative to conventional     surgery.      Thus the investigators propose to conduct a pilot prospective intervenionnal study. The     investigators hypothetized that this technique would reduce morbidity and mortality clinical     but also economic consequences of surgery while making it possible to obtain excellent     results permeability and long-term functionality. This method uses a new concept of tissue     apposition with a fully covered metallic stent to create the anastomosis under endoscopy     exclusively. Ten patients with antro duodenal obstructions requiring surgical or endoscopic     bypass will be included as part of an interventional biomedical research that will be     conducted in one expert center. The duration of the inclusions will be 18 months. Then, the     stent will be removed three months after insertion, at the end of the healing process, and     each patient will be followed for one year. The primary endpoint will be the assessment of     the feasibility of the procedure for gastro duodenal anastomosis using tissue apposition     stenting and NOTES in human being. The secondary endpoints will be the clinical efficacy, the     long term (1 year) patency of the anastomosis, the procedure duration, adverse events,     morbidity and mortality, the quality of life and the length of stay.      In case of failure of the NOTES procedure, the patient will be treated either by surgery or     by conventional endoscopy according to the usual techniques without loss of chance. The risk     / benefit ratio appears positive and a safety report will be issued after the first 4     inclusions. There will be no supplementary examination in patient follow-up in this study for     which a CT iconography and biology are enough. The material used in the context of this work     is consistent with the legislation on medical devices and has received CE Mark (tissue     apposition fully covered stent Axios ®).   "
55274|NCT02562144|"     The enrolled subjects will get an intravenous cannulation in both elbows. The subject will     get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in     one of the elbows, the other intravenous cannulation is placed in the other arm before     placebo spray is placed, the control arm. The pain score during insertion of the cannulation,     the incidence of adverse events and the success rate and degree of difficulty to place an     intravenous cannulation. The subjects and the one who place the cannulations will be blinded     to the treatment.   "
55276|NCT02562118|"     Background: Endocrine therapy is the standard treatment for hormone receptor positive breast     cancer. However, both primary and acquired resistance occurs, and better strategies to     improve treatment outcome and overcome resistance are urgently needed. There is known cross     talk between RET and ER, and preclinical studies have suggested that combining a RET     inhibitor with endocrine therapy may improve cell kill in breast cancer cell lines.      Aim: To determine the safe dose of lenvatinib that can be co-administered with letrozole in a     phase Ib study, followed by a phase II study to determine the efficacy of lenvatinib +     letrozole in post-menopausal patients newly diagnosed with hormone receptor positive breast     cancer in the neoadjuvant setting.      Methods: Eligible patients will be treated with 2 weeks of single agent lenvatinib, followed     by 12 weeks of lenvatinib + letrozole. Blood and tumor samples will be obtained from the     patient serially to study tumor and host factors that may influence drug efficacy and     toxicity.      Importance of the proposed research: The combination of lenvatinib + letrozole may improve     the treatment response in some ER+ breast cancers. The study will seek to identify biomarkers     (eg tumor RET expression) that may select patients most likely to benefit from the     combination therapy.      Potential benefits and risks: The combination may improve treatment response. Adding     lenvatinib may increase treatment risks, but these will be monitored closely. Pharmacokinetic     analyses will also be performed to determine the drug levels achieved in the patients, and     correlate that with treatment toxicity and efficacy.   "
55277|NCT02562105|"     This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients     admitted to the intensive care unit of Mansoura oncology center through a cohort study as     regards their need for mechanical ventilation during two years.   "
55278|NCT02562092|"     This study aims to understand the barriers to receiving HIV testing and retention of care for     at risk and HIV positive young adults. This study also seeks to determine the feasibility and     acceptability of HIV testing in a non-clinical setting.   "
55279|NCT02562079|"     It is a study of basic research with mechanistically objectives and including clinical     biological samples.   "
55280|NCT02562066|"     This randomized, double-blind, controlled, outpatient two-period, two-treatment crossover     study is designed to evaluate the efficacy and safety of amifampridine phosphate in patients     (ages 2 and above) diagnosed with certain genetic subtypes of CMS and demonstrated open label     (amifampridine phosphate) or history of sustained amifampridine benefit from treatment.   "
55281|NCT02562053|"     Three hundred women with severe premenstrual syndrome will be divided into 3 groups using     computer generated random numbers. Group 1 will receiveCombined oral contraceptives (COC)     containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg) daily for 21 days starting     from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2 will     receive fluoxetine 20 mg daily in addition to an oral placebo similar to COC daily for 21     days starting from the 3rd day of menstruation.Group 3 will receive oral placebo similar to     COC daily for 21 days starting from the 3rd day of menstruation in addition to a daily oral     placebo similar in size, color and structure to fluoxetine.   "
55282|NCT02562040|"     The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the     behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but     do not have obstructive sleep apnea, as well as identify factors that moderate responses to     the surgery. Half of participants will receive eAT, while the other half will be observed     with watchful waiting and supportive care.   "
55283|NCT02562027|"     A principle objective of the study is to create a validated risk model for treatment     selection. This will greatly enhance the ability to counsel patients regarding their specific     risks/benefit ratio for surgery or SBRT. This will improve informed decision making on the     part of the patient, and remove much of the subjectivity of treatment selection.   "
72930|NCT02331173|"     The purpose of this study is to evaluate subjects with X-linked retinoschisis in a clinical     setting to collect data on disease progression.   "
55284|NCT02562014|"     The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the     promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role     in preventing diabetes. The investigators aimed to compare the effects of two fermentable     fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids     (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese     (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design,     13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each     day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g     inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test     drink.   "
55285|NCT02562001|"     The spinal cord injury is identified as the major cause of permanent disability worldwide,     with the loss of ability to walk being the largest and most devastating of them for these     patients. In this way, our goal is to analyze the effects of treatment with electrical     transcranial direct-current stimulation of high definition (HD-tDCS) associated with gait     training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the     march of patients with incomplete spinal cord injury (SCI). This randomized double-blind     study will be built on the existing work already conducted at the Physical Medicine and     Rehabilitation Institute of Medical School of the University of Sao Paulo, General Hospital.     Outpatients (GA) and inpatients (GI) with spinal cord injury (AIS C and D) will receive     active or placebo HD-tDCS followed by gait training with Lokomat (GA: 3 sessions / week X 6     weeks = 18 sessions; GI: 5 sessions / week x 6 weeks = 30 sessions). The functional     assessments (through clinical and functional scales, assess gait, muscle strength,     spasticity, balance and pain) and neurophysiological (cortical excitability measured by     transcranial magnetic stimulation) will be held before and immediately after the training     period and after a 3 months follow up. The expected result is that patients that received the     active HD-tDCS presents an improvement over the ground gait after the Lokomat training period     significantly greater than the placebo group, with positive correlations between     neurophysiologic, kinematics and functional measurements.   "
55286|NCT02561988|"     This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of     BLU-285, administered orally (PO), in adult patients with advanced systemic mastocytosis and     other relapsed or refractory myeloid malignancies. The study consists of 2 parts, a     dose-escalation part (Part 1) and an expansion part (Part 2).   "
55287|NCT02561975|"     An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.      There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity     and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2     max). This injury is a new follow-up parameter of cardiac function for the adult.      The nature of damage (vascular or membrane) can be determined by the measure of double     pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).      Today, in chronic heart failure consecutive to a congenital heart disease, there is no data     on evolution of membrane and capillar factors.It is impossible to predict if membrane damage     will be the best factor correlated to the VO2max in patients suffering from complex     congenital heart disease.      Assessing these parameters could be an comparative evaluation of heart-rate exercise     tolerance test with VO2max and an early control of his damage without risks related to     heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart     disease.These results would have an early prognostic value that would permit to refine the     follow-up and the treatment.      The main objective of this trial is to assess the statistic correlation between the membrane     injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in     children and adults suffering from complex congenital heart disease.   "
55288|NCT02561962|"     This is a first in human phase 1 multicenter open label study in subjects with relapsed or     refractory multiple myeloma.   "
55289|NCT02561949|"     The research will first examine data obtained from YRI participants to investigate effects of     the group sessions on psychosocial functioning outcomes in youth aged 15 - 24. The research     also intends to examine whether youth participating in YRI and complementary income     generating activities will fare better than an employment only control group. Finally, the     research intends to examine whether utilizing lay health workers are a is cost-effective and     scalable method for addressing mental health concerns.      The research will investigate the following hypotheses:        1. Participants who are exposed to YRI will demonstrate greater reduction in mental health          and behavioral problems than participants who are waitlisted for YRI over the same          period; emotion regulation will operate as a major mechanism of YRI improvements; high          comorbidity will be a treatment modifier;        2. Improvements in mental health and functioning due to YRI will lead to (mediate) greater          employment outcomes and superior economic self-sufficiency over time; and        3. Homelessness, orphanhood, young parenthood, and high problems in emotion regulation          co-morbid with other mental health conditions will be major moderators lessening the          effectiveness of YRI.        4. Lay and trained practitioners at agencies participating in the combined mental          health-employment program will demonstrate high fidelity to evidence-based treatment          components and that good satisfaction, social support, and professional exchange of          evidence-based practices will emerge.   "
55290|NCT02561936|"     The purpose of this study is to compare the rate and extent of absorption of rilpivirine in     healthy adult participants following: 1) administration of a single dose of two different     oral dispersible tablet formulation candidates and of an oral granules formulation with that     following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT),     after a standardized breakfast; 2) administration of a single dose of one selected oral     formulation candidate (a dispersible tablet or granules) in different fed conditions     (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3)     administration of a single dose of one selected oral formulation candidate (a dispersible     tablet or granules) dispersed in water or in orange juice, in fed condition (standardized     breakfast).   "
55463|NCT02559648|"     This is a single-site, randomized, placebo-controlled, double blind phase 2b clinical trial.     Patients with Thalassemia will participate in this study and will be treated with Denosumab     or placebo. The effect of Denosumab on lumbar spine BMD in patients with Thalassemia Major     and Osteoporosis will be evaluated as compared with control (placebo) at 12 months.   "
55291|NCT02561923|"     The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin     complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters     (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their     effects on the anticoagulant/pharmacodynamic (prothrombin time and endogenous thrombin     potential) changes induced by rivaroxaban at steady state, to better understand their     potential role in bleeding reversal.   "
55292|NCT02561910|"     The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one     year period a total of 1208 inguinal hernias in 952 patients were consecutively operated     using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.      Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the     standard procedure in inguinal hernia repair in future.   "
55293|NCT02561897|"     This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety     and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF)     undergoing clinically indicated implantation or replacement of cardiovascular implantable     electrical devices.The primary objective is to compare the rates of local and systemic     bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous     warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.   "
55294|NCT02561884|"     To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs     Olmetec and Crestor.   "
55295|NCT02561871|"     The purpose of this study is to assess the safety and tolerability of intramuscular     prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2     (human adenovirus-vectored vaccine candidate) in healthy participants.   "
55308|NCT02561702|"     Charcot Marie Tooth Disease is a family of inherited peripheral neuropathies, with over 70     causative genes identified to date.1-4 Muscle cramps are frequent in CMT, affecting up to 85%     of patients with some subtypes of CMT. These cramps impact quality of life and have been     identified as an important therapeutic target for clinical trials in CMT.1-4 There is no FDA     approved treatment for muscle cramps.5 Mexiletine is a sodium channel blocker approved for     treatment of arrhythmias. As a sodium channel blocker, mexiletine offers the promise of     effective therapy for muscle cramps.   "
55397|NCT02560649|"     The aim of current study is to investigate whether the HBsAg clearance rate can be improved     if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B)     patients treated by nucleoside analogue(NUC) achieved HBVDNA<1000copies/ml，and     HBsAg<5000IU/ml; &HBeAg<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks.   "
57153|NCT02537457|"     The objectives of this study are to establish the bioequivalence between rivaroxaban tablet     15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of     rivaroxaban 15 mg in healthy adult male subjects.   "
55296|NCT02561858|"     Patients who are overweight or obese, diabetic or not, share with those who are suffering     from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney     ammoniogenesis default. This results in an overly acidic urine pH which is directly     pathogenic in people predisposed to develop uric stones because the precipitation of urate     soluble uric acid is accelerated in acid medium.      Excess visceral fat, particularly perirenal, this defect may promote formation of renal     ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a     common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat     are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the     pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential     hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are     positively correlated.      Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric     because of anatomical links between kidney stones and greasy environment and because excess     fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic     syndrome.      For the test, the investigators will compare the amount of fat and perirenal renal ability to     form ammonium in patients with uric or calcium lithiasis taking into account the amount of     intra-abdominal fat.   "
55297|NCT02561845|"     Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased     need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and     the population is well suited to demonstrating rosuvastatin's low density     lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI patients are at very high CV risk,     and as such here is an increased need for intensive lipid management in PCI patients and the     population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose     of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C,     high density lipoprotein-cholesterol (HDL-C), Triglyceride (TG), and non-HDL-C) and lipid     goal attainment according to recent guidelines.   "
55298|NCT02561832|"     This is an open-label study to assess the safety, tolerability and efficacy of olaparib in     combination with carboplatin. There are two parts in this study: Part A, a dose escalation in     patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and     Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer     patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.   "
55299|NCT02561819|"     This study will determine if air-displacement plethysmography (ADP) provides accurate     measurement of body composition (percent body fat and fat-free mass) in pediatric patients     with intestinal failure, as compared to body composition measured by alternative standard     methods, including deuterium dilution, bioimpedance analysis (BIA), dual x-ray absorptiometry     (DXA) when clinically indicated, and routine anthropometric measurements.   "
55300|NCT02561806|"     The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab     compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.   "
55329|NCT02561429|"     Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy     and safety of SPT were proved. The positive control of SPT is histamine.      In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some     practice they use other concentration (1, 2.5 mg/ml).      This study will find the proper concentration of histamine for positive control use in SPT.   "
72956|NCT02330835|"     This project evaluated a multimedia student behavior management program for school bus     drivers and school administrators.   "
55301|NCT02561793|"     440 women with expected poor ovarian response undergoing IVF/ICSI (intracytoplasmic sperm     injection) will be randomly divided into 2 groups using computer generated random numbers .     Group 1 ( study group) will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol ,     USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle. Group 2 ( control group) will     receive a placebo. Patients included in the study will be subjected to full history taking     and clinical examination. On the second day of menstruation serum FSH, LH, Prolactin and     Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using a     vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin     (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On     the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal     probe. Oocytes will be aspirated 34-36 hours after HCG administration. Oocytes will be     fertilized and embryos will be transferred. Both groups will be compared regarding the     proportion of pregnancy.   "
55302|NCT02561780|"     This study examines the effectiveness of a school based mental health literacy intervention     for high school students, on improving mental health knowledge and reducing stigma.     Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to     either the curriculum or control condition at a two to one ratio. The educational curriculum     was integrated within grade 11 and 12 Provincial Healthy Living courses, delivered by     teachers, and replaced existing educational content on mental health.   "
55303|NCT02561767|"     This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived     mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death     (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into     two groups: MSCs group and control group. Besides routine induction therapy (ATG or     Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA +     prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic     bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion     during surgery), day 7, day 14 and day 21. The renal allograft function, rejection,     patient/graft survival and severe adverse events within 12 months post-transplant are     monitored.   "
55304|NCT02561754|"     The goal of this study is to explore the impact of two different diets (conventional vs.     enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight     across 18 months in overweight and obese adolescents with intellectual and developmental     disabilities.   "
55305|NCT02561741|"     A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study     conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on     the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.   "
55306|NCT02561728|"     The purpose of this study is to examine a group of patients requiring helmet therapy (either     patients with plagiocephaly or post-surgical patients) to compare outcomes of infants treated     with the Hanger helmet (Hanger, Inc.) to outcomes of infants treated with the P Pod Helmet     (Lorica Scientific, LLC). Currently both helmets are prescribed at CCHMC. The investigators'     goal is to determine which helmet is more effective in skull remodeling and to standardize     the investigators' care for these patient types.   "
55309|NCT02561689|"     Background: Occlusal caries is the main reason for restorative therapy in the young permanent     dentition, but restorations have limited survival time and may also weaken the tooth. An     intact fissure sealing is an effective preventive treatment of occlusal caries lesions and     may be used therapeutically to arrest the caries progression. However, the major challenge     with fissure sealants is the frequent need for re-treatments, mostly due to inadequate     retention.      Purpose: To quantify the longevity and effectiveness of the 6 resin sealants used     prophylactically and therapeutically in permanent molar teeth.      Study design: The study is carried out as a prospective, clinically controlled study with     split-mouth design, where each of the 60 dentists/dental hygienists from 13 municipalities in     Denmark uses 2 of the 6 sealants. The treatments are examined clinically and radiologically     after 1, 2, 3, and 5 years.   "
55310|NCT02561676|"     Chronic pain (pain that is that is present for a long period of time) is very common among     people with spinal cord injury (SCI).      The purpose of this study is to compare how well two different web-based education programs     reduce the level to which chronic pain interferes with daily activities and well-being.   "
55311|NCT02561663|"     Rationale: Subjects with the metabolic syndrome have an increased risk of developing     cardiovascular disease and a twofold risk of developing hypertension. A functional food     ingredient with the ability to improve arterial stiffness, microcirculation and/or the     ability to reduce blood pressure could potentially contribute to the delay or prevention of a     range of cardiovascular diseases and could provide additional complimentary alternatives to     pharmacological and lifestyle based interventions in the maintenance of cardiovascular     health.      Objective: To assess the acute (2h) and short term (2 days and 4 week) effects of daily     administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave     Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral PWV,     characteristics of microcirculation, systolic and diastolic blood pressure, lipid and     lipoprotein metabolism, glucose metabolism and incretins.      Study design: Investigators propose to carry out a randomized, double-blind, placebo     controlled crossover study.      Study population: Eligible subjects will be male or female, non-smokers between 18-75 years     of age and will be otherwise healthy, but meeting at least three criteria of the Metabolic     Syndrome (MetS). It is estimated that 80 otherwise healthy subjects with MetS will be     randomised, to result in a minimum of 72 evaluable subjects (drop out maximal 10%) at the end     of the study.      Intervention: Subjects will be randomly allocated to receive 5g of NWT-03 and placebo, once     daily, on separate occasions, for a period of 4 weeks and with a washout period between the     two interventions of typically 4 weeks. However, this period may be shortened by 2 weeks or     extended by 8 weeks, depending on the availability of the subject. Total study duration will     be 10 - 16 weeks, depending on the duration of the washout period.      Main study parameters/endpoints: Measurements will be performed at the start and end of each     4-week intervention period. Effects of NWT-03 supplementation will be calculated as the     absolute differences between values obtained at each period. The main study endpoint is the     change in cr-PWV.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Before the study starts, subjects will be screened to determine eligibility     during a screening visit. During this visit, body weight, height, waist circumference and     blood pressure will be measured and a venous blood sample (10 mL) will be collected. During     the study, subjects will receive NWT-03 and placebo powders in random order and are asked to     consume it on a daily basis. At visits 2, 3, 4, 5, 6 and 7 (days 0, 2, 27, 56, 58 and 83 of     the study), cr-PWV, cf-PWV and office blood pressure will be recorded. A fundus photograph     and a blood sample (20mL) will be taken in fasting condition. 2 hours after intake of the     designated study product cr-PWV, cf-PWV and office blood pressure will again be measured and     another fundus photograph will be taken. Additionally, a blood sample (20 mL) will be     collected. Thus, in total 270 mL blood will be drawn. A pregnancy test will be taken in     females of childbearing potential at visits 2 and 5. Subjects will be asked to fill out a     food frequency questionnaire and to provide a spot urine sample at visits 4 and 7.     Furthermore, subjects will be asked to keep a study diary throughout the duration of the     study. Total time investment for the subjects will be approximately 19 hours. Apart from     bruises or hematoma, rarely induced by blood sampling, no risks are associated with     participation in this study.   "
55312|NCT02561650|"     A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study     conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on     the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.   "
55313|NCT02561637|"     Patients in fast-track programmes are required to take an active part in their treatment and     rehabilitation. Spouses of older patients can often provide valued practical and emotional     support, reducing stress, pain and length of stay - yet they are seldom invited to     participate in a supporting role. The aim of this study is to investigate the effect of     spouses' involvement in older patients fast-track treatment programs using case management as     intervention. A two-group quasi-experimental design with pre-test and repeated post-test     measures (protocol approved in November 2012) was used. Patients aged 65 years or older going     through a fast-track programme for a total hip replacement and their spouses was recruited in     dyads from one Danish orthopaedic ward for the intervention group (n=15) and for the control     group (n=14). Data was collected from both groups at baseline, two weeks and three months     after surgery. Outcome measures for patients include: functional status, nutrition, pain,     depression and healthcare consumptions; and for spouses: caregiver satisfaction and     difficulties and anxiety.   "
55349|NCT02561169|"     A multi-centre, randomized, placebo controlled, trial. Participants will be patients either     ≥65 years or with one or more high risk conditions presenting to one of four academic     emergency departments in Edmonton or Calgary with influenza-like illness. The investigators     will test for influenza using a point-of-care rapid test and if positive for influenza     participants will be randomized to oseltamivir or placebo and followed prospectively. The     primary outcome will be hospitalization.   "
55350|NCT02561156|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of     TAK-653 when administered as single and multiple oral doses at escalating dose levels in     healthy participants.   "
55314|NCT02561624|"     The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria     prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net     distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to     electronic vouchers in this program has increased efficiency and the ability to track and     distribute nets since 2007. Although the program has been successful, to date, electronic     voucher redemption varies widely across the country and it has not been clearly established     as to what barriers exist for women who receive electronic vouchers in the program. This     cluster-randomized trial was designed to examine perceived barriers to electronic voucher     redemption among pregnant women and to evaluate if educational and personalized text messages     around electronic voucher redemption and bed net usage will increase electronic voucher     redemption when directed at pregnant women who receive electronic vouchers in the currently     existing program.   "
55315|NCT02561611|"     The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative     multi-component intervention focused on increasing energy expenditure and re-balancing the     disrupted energy balance equation of sedentary workplaces with an ultimate target of reducing     workers' abdominal obesity.   "
55316|NCT02561598|"     The purpose of the study is to develop methods to identify predictors of Malignant     Hyperthermia.   "
55317|NCT02561585|"     This clinical trial attempts to investigate the efficacy and safety of LEO 124249 in the     treatment of alopecia areata and the molecular disease mechanism and biomarkers.   "
55318|NCT02561572|"     Preoperative anxiety has been associated with adverse consequences, including increased     anaesthetic and analgesic requirements and overall dissatisfaction with care. Traditionally     this has been treated with sedative drugs, such as benzodiazepines, but these can be     associated with a sedative hangover with sedation continuing into the postoperative period.     This is undesirable in patients undergoing neurosurgical procedures, as there is a need to     assess neurological status in the immediate postoperative period. Acupuncture at the Yintang     point (on the forehead between the eyebrows) has been shown to effectively reduce     preoperative anxiety, but studies undertaken in the United Kingdom and neurosurgical     population are lacking. The investigators aim to investigate the effect of acupuncture at the     Yintang point on preoperative anxiety. Anxiety levels will be measured using two validated     questionnaires: the State-Trait Anxiety Inventory (STAI) and Amsterdam Preoperative Anxiety     and Information Scale (APAIS).   "
55319|NCT02561559|"     In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is     to evaluate rate of local control of treated lesions in patients treated with Intensity     Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung     metastases from STS.   "
55320|NCT02561546|"     An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in     treatment of diabetes concurrent with hepatocellular carcinoma (HCC).   "
55321|NCT02561533|"     Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle     aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the     mutation specific antibody VE1.   "
55322|NCT02561520|"     The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich     Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of     ocular graft versus host disease (O-GVHD). In addition to their current medication (except     autologous serum drops), patients will receive PRP and PPP drops.   "
55323|NCT02561507|"     This is a survey of members of the American College of Surgeons (ACS), to describe and     explore current patterns of their decisions about withholding or continuation for patients     taking aspirin (ASA) in the perioperative period. Secondarily, the survey will also explore     surgeons' knowledge about the risks and benefits attending this decision, and about national     organizations' recommendations.   "
78393|NCT02259790|"     Study to investigate the relative bioavailability of fixed-dose combination tablet vs.      mono-components of telmisartan and amlodipine   "
55325|NCT02561481|"     ASD is a diverse disorder starting in early childhood and characterized by social     communication impairment as well as restricted interests and repetitive behaviors. It affects     1:68 children and is an enormous medical and economic problem for which there is no     established, mechanism-based treatment. Sulforaphane is an isothiocyanate derived from     broccoli, and has potent activity in transcriptionally up-regulating genes that control     mechanisms whereby aerobic cells protect themselves against oxidative stress, mitochondrial     dysfunction, and inflammation.      This study is a clinical trial of oral sulforaphane (as broccoli seed powder) in 50 boys and     girls (3-12 years) with ASD in 3 phases over 36 weeks. In Phase 1, 25 children will receive     active drug and 25 will receive placebo for 15 weeks; in Phase 2, all children will receive     sulforaphane from 15-30 weeks; in Phase 3, children will receive no treatment for 6 weeks.     Study visits will take place at screening, 7, 15, 22, 30 and 36 weeks, when the Ohio Autism     Clinical Clinical Impressions Scale - Severity and Improvement (OACIS-S and OACIS-I),     Aberrant Behavior Checklist (ABC) and Social Responsiveness Scale (SRS) will be recorded.     Children will be monitored with physical examinations and for toxicity with clinical     laboratory studies and examine possible biomarkers: Nuclear factor-erythroid factor 2 (Nrf2),     oxidative stress and mitochondrial function, the mechanistic target of rapamycin (mTOR)     pathway and cytokine expression. In addition, prior to the main clinical trial, a pilot study     will be carried out in 10 children with ASD, 6-12 years of age, who will receive     sulforaphane, 2.2 micromoles/kg daily for 14 days. Blood and urine samples before and at the     end of treatment will be collected, in order to measure several parameters that are likely to     demonstrate expected effects of sulforaphane, to standardize the assays and procedures, and     to determine the most effective measures.   "
55326|NCT02561468|"     Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast     cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be     reduced.   "
55327|NCT02561455|"     The purpose of the study is to provide access to continued treatment for subjects who     participated in other Astellas sponsored ASP2215 trials that completed the primary analysis     and for whom the Investigator feels may have potential to continue to derive clinical benefit     from the treatment with ASP2215, and who did not meet any of the study discontinuation     criteria in the present study.   "
55328|NCT02561442|"     The proposed study aims to assess the time above MIC (4 mg/mL), and the     pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by     constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone     administered as a constant IV infusion over 0.5 hours. In addition, the study will compare     the results obtained after 1 g ceftriaxone intravenous or subcutaneous administration with 2     g ceftriaxone administered subcutaneously   "
64866|NCT02436629|"     The objective of the current study is to assess the effect of 6-day dietary nitrate ingestion     on high intensity intermittent sports performance in recreational soccer players.   "
55330|NCT02561416|"     Purpose:      Fibromyalgia syndrome (FMS) is a disabling condition mainly characterized by chronic     widespread pain, disturbed sleep, fatigue, and distress. The estimated overall prevalence of     FMS in Europe is 2.9% and it incurs in high personal, social and healthcare costs. Available     treatments in FMS are not curative and there is some evidence of positive effects of     mindfulness-based stress reduction (MBSR) in patients with chronic pain and FMS.     Nevertheless, although promising, the positive findings obtained in previous studies     implementing mindfulness-based interventions in patients with FMS have to be interpreted with     caution due to important methodological limitations (e.g. absence of randomization, high     attrition rates, or small sample sizes). Therefore, further research in larger studies using     more adequate methodologies is warranted. Furthermore, little is known about putative     neurobiological processes underpinning the effects of mindfulness training in patients with     chronic pain.      Aims: The aim of this randomized, controlled trial (RCT) is two-fold: firstly, to assess the     effectiveness and cost-utility of MBSR added to treatment as usual (TAU); and secondly, to     evaluate the effects of the compared interventions on neurobiological parameters.     Specifically, MBSR will be compared to an active control which was previously reported as a     cost-effective intervention (TAU + FibroQol psycho-educational program; Luciano et al., 2013)     and also vs. TAU alone (in a 12-month follow-up RCT). Brain structure and function of     pain-relevant areas and levels of inflammation markers (cytokines) will be assessed pre-post     interventions in half of the study participants.      Methods:      Design: RCT with three arms:        1. TAU + MBSR,        2. TAU + FibroQoL and        3. TAU.      Sample: 180 adults with FMS according to the ACR 1990 criteria (N=60 for each study arm) will     be recruited from from the Parc Sanitari Sant Joan de Déu Rheumatology Service, Sant Boi de     Llobregat, Spain. Half of the participants will be randomly selected to participate in the     neurobiological pre-post evaluation (N= 30 each group). All patients will be assessed at     baseline, post-intervention and 12-month follow-up for clinical variables, prep-post     intervention for biomarkers study, and baseline and 12-month follow-up for cost-related     variables.   "
55331|NCT02561403|"     The purpose of this study is to conduct a pilot trial investigating cognitive training in     older Veterans with a history of traumatic brain injury (TBI) to assess training effects,     acceptability of training to participants, and to explore whether other factors influence     training effects.   "
55332|NCT02561390|"     The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC     found that prevalence of AR and asthma inThailand was in moderately high group.      Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of     allergen in patient. They guided the investigators for proper management as well as patient     education. Clinician will use the result for choose allergen in case that might need     immunotherapy.      SPT is safe and more economic for patient. Specific IgE has an advantage in patient who     cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT     and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two     tests. In Thailand, the investigators haven't had data about it yet.   "
55333|NCT02561377|"     This study evaluates the efficacy of a 12-month resistance training on metabolic control and     reducing the risk of diabetes.   "
55334|NCT02561364|"     The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in     pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile     (BPP) is a score that is intended to assess fetal well-being. This test will be performed     within the expected time of the routine ultrasound exam.   "
55335|NCT02561351|"     The purpose of this study is to determine mean or median of fractional exhaled nitric oxide     (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma     exacerbation according to the global initiative for asthma guideline.   "
55336|NCT02561338|"     This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type     2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will     receive placebo.   "
55410|NCT02560480|"     The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This     observational case-control study follows three contact sport teams (soccer, ice-hockey and     bandy) for two years to find out the prevalence and reasons for groin pain. Clinical     examination, pain scores and pelvic magnetic resonance imaging (MRI) are performed. Hip and     groin questionnaire (HAGOS) is used to determine severity of groin injuries.   "
55337|NCT02561325|"     Many large-scale epidemiological studies have established a link between the average     consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted     in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health     authorities considered it appropriate to reduce consumption about 20%, by limiting     contributions of sodium in prepared foods, bread.      In terms of basic and clinical research, the biological effects of sodium chloride dietary     intake, have been the subject of numerous studies for several decades. This work showed that     all subjects do not react uniformly to sodium chloride flows, determining what the     investigators call people sodium-sensitive. For these people the sodium intake elevated     blood pressure, much more marked than in subjects called sodium-resistant.      Sodium-sensitive people represent 10 to 30% of the population. A marked over-representation     of this phenotype was observed in patients with hypertension or a family history of     hypertension.      In addition, studies conducted in animals and humans indicate that sodium intake has a     different impact on biological parameters mentioned above, as is done in the form of chloride     salt or bicarbonate of sodium.      Based on these factors, investigators developed a clinical trial protocol intended to     highlight a possible differential effect in the biological effects of the same sodium intake     (2.56 g / day) orally, depending on the nature salt.   "
55338|NCT02561312|"     Chronic blood transfusions are essential supportive care for sickle cell patients at high     risk for morbidity and mortality due to stroke. These patients, however, are at risk for iron     overload. In the investigator's comprehensive sickle cell center, the investigators support     chronic transfusion with rapid manual partial exchange transfusions (RMPET) using a single     access central line port. The investigators do not have a comprehensive adult sickle cell     program but upon transition of patients the patients would be provided simple transfusion     (ST) in an adult ambulatory infusion setting due to nursing acuity needed for RMPET. The     investigators plan to study the institution's participants currently on chronic transfusion     support and compare different transfusion modalities to better understand the effects from     switching from RMPET to ST. To date, there are no such comparisons within and between sickle     cell patients in the literature.   "
55339|NCT02561299|"     The purpose of this study is to prospectively evaluate acute and long term clinical results     of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB     angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK)     lesions.   "
56168|NCT02550431|"     This study plans to learn more about puberty blockers and cross (testosterone and estradiol).     There is not much known about how these medications affect hormone levels, heart health and     overall general health in young transgender individuals.   "
55340|NCT02561286|"     The incidence of HIV/AIDS among African American men who have sex with men (MSM) is alarming,     and the public health response to this urgent situation has been hampered by a lack of sexual     risk reduction interventions with solid evidence of efficacy in this population. Accordingly,     the broad, long-term objective of the proposed research is to identify interventions to     reduce the risk of sexually transmitted infection (STI) among African American MSM. This     application seeks funds to develop and test the efficacy of a theory-based, contextually     appropriate behavioral intervention to reduce sexual risk behavior among African American     MSM. Intervention development will be guided by social cognitive theory, the theory of     planned behavior, qualitative information from focus groups, and findings from a longitudinal     survey of men from the study population. A one-on-one intervention will be utilized to     address the specific prevention needs of each man and to allay participants' concerns about     revealing their sexual involvement with men by virtue of participating in a group or workshop     intervention. The study will utilize a randomized controlled trial design, with baseline,     immediate post intervention, and 6 and 12 months post intervention assessments. The     participants will be African American MSM who will be randomized to a one-on-one sexual risk     reduction intervention or a one-on-one health promotion intervention that will serve as the     control condition. The primary outcome is consistent condom use during anal and vaginal     intercourse. The study will test whether the intervention increases the consistent use of     condoms during anal intercourse, the primary outcome, whether it decreases other sexual risk     behaviors, and whether social cognitive theory variables mediate the effects of the     intervention on consistent condom use. This study will provide an urgently needed     intervention to reduce the risk of HIV and other STIs in one of the highest risk populations     in the United States.   "
55341|NCT02561273|"     This phase I/II trial studies the side effects and best dose of lenalidomide when given     together with combination chemotherapy and to see how well they work in treating patients     with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and     etoposide, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may     stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new     blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide     may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.   "
55342|NCT02561260|"     In recent years, more and more previously thought to be unknown encephalitis was found to be     a specific antigen associated encephalitis，but because of the lack of recognition in the     clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to     establish a database of autoimmune encephalitis in Chinese population. The prospective     clinical trial of atutoimmune encephalitis in China, by screening the autoimmune encephalitis     associated antibody and summarizing the cases analysis, in order to provide evidence for     clinical diagnosis and treatment of autoimmune encephalitis.   "
55343|NCT02561247|"     The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex®     HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement     therapy to effectively treat acute kidney injury (AKI) in pediatric patients by reducing     blood urea nitrogen (BUN).   "
55344|NCT02561234|"     This is the first-in-human study of the safety of increasing dose levels of AEB1102 in     patients with advanced cancers. The study will also evaluate the amounts of AEB1102 in blood,     the effects of AEB1102 on blood amino acid levels and tumor growth.   "
55345|NCT02561221|"     The primary aim of this trial is to develop and test the effectiveness of a 24 month,     patient-centered, pragmatic and scalable obesity treatment program delivered within primary     care, inclusive of an underserved population. Half of the participants will receive a     behavioral intervention delivered in a primary care setting and half of the participants will     receive usual care.   "
55411|NCT02560467|"     The objective of this study is to determine whether myocardial contrast echocardiography in     patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or     stress induced perfusion defects due to associated abnormalities in intramyocardial arteries     and the microcirculation. A secondary aim will be to determine whether abnormalities in     perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence     of arrhythmias, and regional function of the septum.   "
56210|NCT02549885|"     The purpose of this study is to determine whether the contract-relax technique of     proprioceptive neuromuscular facilitation, and the static stretching exercise are effective     in reducing the frequency, intensity and duration of headache and in improving the perception     of quality of life in women with migraine.   "
55346|NCT02561208|"     Cervical cancer remains a serious health problem, particularly in developing countries. It is     the leading cause of cancer death among women and mainly affects women of low socioeconomic     status.      Evidence has shown that HPV-test self-collection can reduce social and health services     barriers to screening and increase coverage. However, high coverage will not result in a     decrease of disease burden if women are not diagnosed/treated. The HPV-test indicates whether     a woman is positive or not, and a triage test is needed to identify HPV-positive women who     need to perform diagnostic procedures. Several triage methods are available. In Argentina,     cytology is used as triage method; therefore, all HPV-positive women who have performed     self—collection at home need to attend health centers to undergo cytology. However, the     proportion of women who have completed triage is low, therefore new innovative strategies are     needed to increase attendance to cytology of these women.      This study will be carried out in Jujuy, one of the Argentinian provinces with highest     cervical cancer mortality rates and where HPV- self-collection has been introduced as     programmatic strategy for screening under-users.      This trial is population-based cluster-randomized study that aims to evaluate the     effectiveness of a mHealth intervention versus usual care to increase adherence to     cytological triage among women with HPV-positive self-collected tests.      An overall number of 240 Community Health Workers (CHWs) from the Primary Health Care System     (PHCS) of the Province of Jujuy will be randomized into two groups:        1. mHealth Intervention Group: Women with HPV self-collected tests will receive a mixed          intervention which includes counseling through an interactive Apps specifically devised          to increase adherence to triage which will be run on a tablet, and SMS text messages to          remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services          and CHWs will receive reminders via e-mails and SMS message to contact women if after 60          days from the HPV-results HPV+ they have not performed triage.        2. Usual Care Group: Women with HPV self-collected tests receive usual care.      A database built specifically for the study will be used; it will include data about     randomization Group, agreement to participate in the study and socio-demographic data. Data     on HPV-testing and triage will be uploaded importing the data from SITAM, using the Unique     Identification Number (DNI).      Data Analysis      Effectiveness to enhance adherence to cytological triage: Adherence to triage will be     considered for each CHW. This will be defined as the number of women with triage smears     within 30, 60 and 90 days. There will be a comparison of the percentage of HPV-positive women     that did the Pap test within those time intervals in the mHealth intervention group and the     Usual Care group. The effect of the mHealth intervention against usual care will be estimated     using a means difference test or a non-parametric test for independent samples.   "
55347|NCT02561195|"     This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85     years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination     schedules. The study will assess the safety and tolerability of the vaccine as well as the     subjects' immune response to the vaccine. One year after the third dose subjects that did not     receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up     to 4 years after their third vaccination.   "
55348|NCT02561182|"     The goal of this study is to determine whether or not patients with overgrowth syndromes have     decreased bone density.   "
56169|NCT02550418|"     The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9     mg budesonide in patients with active ulcerative colitis   "
55351|NCT02561143|"     Investigators are evaluating the nutritional role of IAtta supplementation along with     nutritional counselling in delaying the progression of cachexia to refractory cachexia in     adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100     g) for daily consumption for 6 months. Dietary and physical activity counseling will be     imparted every fortnight to patients.      Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at     baseline, after 3 months and at 6 months of intervention for all patients.      Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary     and physical activity counselling) for six months will improve the health status and quality     of life in free-living patients suffering from cancer cachexia.   "
55352|NCT02561130|"     The purpose of the study is to determine whether in patients with early type 2 diabetes, a     short-term intensive metabolic intervention comprising Forxiga, metformin, basal insulin     glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving     sustained diabetes remission.   "
55353|NCT02561117|"     The objective of this study is to determine whether administering once-daily doses of     metronidazole, an intravenous (IV) antibiotic used to prevent infection in perforated     appendicitis, is as effective in children as delivering it in the standard method of once     every eight hours. Reducing the frequency of administration has the potential of decreasing     personnel time and healthcare cost and increasing the lifespan of the IV line.      To determine the effectiveness once-daily administration, a randomized controlled trial (RCT)     will be conducted to compare outcomes between the two treatment schedules. We will recruit     100 patients (50 per treatment) aged 5-18 being surgically treated for perforated     appendicitis at the Children's Hospital of Eastern Ontario, who will be randomly assigned to     one of the two treatment schedules. To compare the efficacy of the treatments, outcomes such     as duration of hospital stay and theoretical cost will be measured and analyzed using     statistical tests.   "
55354|NCT02561104|"     The study design will be a prospective study comparing laser-assisted cataract extraction     cases and traditional manual phacoemulsification cases. All cases will be performed by     faculty-supervised residents at Parkland Memorial Hospital. This study aims to examine visual     acuity and complication rates in femtosecond laser-assisted cataract surgery compared to     traditional manual phacoemulsification cataract surgery for the beginning surgeon. In     addition, this study will assess the subjective novice surgeon experience and the patient     experience in terms of expectations and results.   "
55355|NCT02561091|"     The purpose of this research study is to test the effectiveness and safety of the study drug,     AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the     cause is unknown.   "
55356|NCT02561078|"     The main purpose of this study is to evaluate the efficacy and safety of the study drug known     as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin     infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes     mellitus.   "
55357|NCT02561065|"     The main objective of TANSNIP-PESA is to determine in a population of asymptomatic bank     employees with high and low imaging defined cardiovascular disease (CVD) risk the     effectiveness of a comprehensive 3-year worksite-based lifestyle intervention consisting of     12 personalized lifestyle counseling sessions, a Fitbit physical activity tracker and a     sit-stand Workstation.   "
55480|NCT02559427|"     The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea     in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea     Syndrome (OSAS).   "
55358|NCT02560012|"     This is for subjects with metastatic Renal Cell Cancer (RCC). There are four Food and Drug     Administration (FDA) approved drugs for first-line therapy of Renal Cell Cancer (RCC) and two     for second-line therapy. Each of these drugs targets a specific molecular pathway. At present     oncologists select therapy based on current guidelines. There is a new method for trying to     use biomarker information from the subject's tumor to select the best drug to treat the     subject. This process is investigational, which is why this study is being done.      Biomarkers are genes, proteins and other molecules that affect how cancer cells grow,     multiply, die and respond to other compounds in the body. These biomarkers build a tumor     profile or fingerprint of the subject's tumor. A new focus in cancer care is personalized     treatment, where doctors select a drug based on the subject's tumor's unique fingerprint     which is more likely to be effective in fighting the tumor. Selecting the treatment the     subject is more likely to respond to requires a thorough understanding of the relationship     between biomarker and treatment effect. The PI wants to gather data to understand that     relationship to help treat future cancer patients. The purpose of this study is to evaluate     efficacy of treatments that are selected based on tumor profiles.   "
55359|NCT02559999|"     Determine objective markers of pain perception remains a major scientific and medical issue.     Various tools have been proposed to objectify pain, but their adaptability to different     clinical contexts are limited. Our working hypothesis considers that the research for markers     of immediate pain perception should be based on an electrophysiological approach, based on     the combined analysis of EEG and autonomic responses.   "
55360|NCT02559986|"     Postpartum depression (PD) is a serious and disabling mental health condition that affects     10-15% of women after childbirth. Low-income minority women are disproportionately affected.     Untreated PD can lead to significant negative outcomes for both mother and child.     Pediatricians are being asked to routinely screen for PD and while screening rates are     improving, little is known about whether mothers actually adhere to pediatrician     recommendations to seek additional help after a positive PD screen. The objective of this     study is to describe the rate at which mothers seek treatment for suspected PD after a     positive screen at the pediatrician office. Additional examination will look at factors that     predict whether a mother recalls a recommendation to seek treatment.   "
55361|NCT02559973|"     This is a single-center, randomized, open-label, single-dose, parallel-group study which will     enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use     disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential     (Inpatient) and Non-Residential (Outpatient) Period.   "
55362|NCT02559960|"     This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the     potential risk factors for the adverse drug reactions.   "
55364|NCT02559921|"     This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and     tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells)     in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only,     rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for     human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in     combination with rabies vaccine for human use,and placebo in combination with rabies vaccine     for human use,respectively.   "
55365|NCT02559908|"     This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel     for the restoration and creation of facial volume in participants seeking to increase     projection of the chin and/or jaw.   "
55366|NCT02559895|"     The purpose of this study is to assess ALD403 in the prevention of migraine headache in     frequent episodic migraineurs.   "
55367|NCT02559882|"     The study aimed to assess the success of a clinically indicated renal denervation by     different tests and correlate the results of the tests with the clinical outcome.   "
55368|NCT02561039|"     This study will assess the efficacy and safety of ibandronate (Bondronat), administered     intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate     to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV     infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky     Performance Index (KPI) will be measured at intervals throughout the study. The anticipated     time on study treatment is 4 months and the target sample size is 150 individuals.   "
55369|NCT02561026|"     Frozen plasma (FP) is commonly transfused to patients with abnormal coagulation results prior     to medical procedures associated with a risk of bleeding (e.g. involving a needle or     incision). The most frequent group that requires FP transfusions are patients admitted to an     intensive care unit. These patients frequently have abnormal coagulation tests and also     frequently require invasive medical procedures that can be associated with bleeding. While FP     transfusions can improve abnormal coagulation test results, there is no evidence to suggest     that prophylactic FP transfusions will reduce bleeding associated with medical procedures in     patients with mild coagulation abnormalities. Additionally, it is known that important     adverse complications occur with FP transfusions.      The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU     patients who require an invasive medical procedure (central venous catheterization, chest     tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals.     Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP     transfusion or no treatment prior to an invasive procedure.      The primary outcome for this pilot study will be feasibility (the number of patients enrolled     per month). Other important outcomes will include those that will be evaluated in the     definitive trial including bleeding post procedure, red cell transfusions, adverse     transfusion reactions, mortality and hospital length of stay.      The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.   "
55370|NCT02561013|"     The purpose of this study is to evaluate the product performance of a new adjustable     compression system for the treatment of venous leg ulcers.   "
57154|NCT02537444|"     To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and     acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian     cancer   "
55373|NCT02560961|"     Introduction: Kinesio taping consists of the attachment of a thin elastic tape over specific     muscles, the thickness of which is similar to that of the epidermis. This tape can be     stretched to 140% of its original length, which demonstrates greater elasticity in comparison     to conventional bandages. According to the creator of this method, Kinesio taping leads to     better muscle activation or inhibition, reduces pain, swelling and muscle spasms and prevents     muscle injury. Objective: The aim of the proposed study is to compare and analyze the     immediate effect of Kinesio taping and placebo taping on performance during unilateral     vertical jump and two hop tests by young professional soccer players. Methods: A randomized,     placebo-controlled, double-blind, clinical trial will be conducted involving 100 athletes.     The volunteers will be submitted to an evaluation of the dominant lower limb using the Single     Leg Hop Test and Single Leg Triple Hop Test as well as the evaluation of a unilateral     vertical jump on a pressure platform. The athletes will then be randomly allocated to two     groups. Group A will receive Kinesio taping of the triceps surae muscle as described by Kase     (2003, 2013) and Group B will receive a placebo taping of the same muscle. After 30 minutes,     the volunteers will be submitted to the same evaluation tests. Analysis: Intra-group and     inter-group analyses of the results will be performed. Statistical tests will be conducted     considering a 5% significance level.   "
55374|NCT02560948|"     gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.     The purpose of this study is to demonstrate the clinical efficacy and safety of a     subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic     rhinoconjunctivitis compared to placebo.   "
55375|NCT02560935|"     The overall goal of this proposal is to conduct a partial double-blind randomized Phase III     clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in     sub-Saharan Africa.   "
55385|NCT02560805|"     The purpose of this study is to find out why patients with post-traumatic stress disorder     (PTSD) have an increased risk for heart disease and high blood pressure later in life. A     second purpose is to find out what causes PTSD patients to have high adrenaline levels during     stress. This study will also test if a medicine called losartan improves high adrenaline     levels in patients with PTSD and if a certain gene that has to do with high blood pressure     might be associated with high adrenaline levels.   "
55386|NCT02560792|"     The primary goal of this study is to determine experimentally the relationship between     affective response to exercise and future exercise behavior. A secondary goal is to examine     potential mediators and moderators of this relationship, specifically four variables     considered to contribute to the volitional control of exercise behavior - planning,     attention, resource commitment, and affect regulation. An additional goal is to examine how     symptoms of depression might influence the affective response to exercise, and the     relationship between affective response to exercise and exercise behavior.   "
65317|NCT02430753|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.   "
55376|NCT02560922|"     This study will examine the effectiveness of an 11-session, culturally enhanced,     telephone-based pain coping skills training program among African Americans with hip or knee     OA. The study team will enroll n=248 African Americans with hip or knee OA. The participants     will be randomized into two groups. One group will take part in an 11-week pain CST     intervention. The other group will be a wait list that receives the pain CST program after     completing all follow-up study measures. All study participants will be able to continue any     other usual medical care for their OA during the study period. The pain CST intervention     includes 11 individual sessions with a study counselor, delivered via telephone to enhance     access and reach. The sessions include the following: general information about why pain     coping skills training is important, training in specific pain coping skills (such as     progressive muscle relaxation, communication, imagery, and activity pacing), and guided     practice with each skill. The CST program will also include information about other behaviors     important for OA, such as physical activity and weight management. The main study outcome     will be the pain subscale of the Western Ontario and McMasters Universities Osteoarthritis     Index (WOMAC). Other outcomes will include the WOMAC function subscale, Coping Strategies     Questionnaire, Arthritis Self Efficacy Scale, depressive symptoms, Health-Related Quality of     Life, and Patient Global Impression of Change.   "
55377|NCT02560909|"     Influenza virus is an important cause of morbidity in the transplant population and can lead     to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for     transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity.     There are no studies that define the effect of adjuvanted vaccine in this population. The     purpose of this study is to determine if a vaccination with FLUAD® results in improved     immunogenicity as compared to standard vaccine in allo-HSCT recipients. Immunogenicity will     be assessed by standard quantitative antibody titer assessments and using cell-mediated     immunity measurements.   "
55378|NCT02560896|"     Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought     to proceed when the research participant in a biobank is deceased and there is clinically     relevant information that could be disclosed to family members. This study is designed to     test a procedure offering genetic information to family members of research participants who     participated in a pancreatic cancer biobank in a Health Insurance Portability and     Accountability Act (HIPAA) -compliant design.   "
55379|NCT02560883|"     The overall objective is to develop a clinical data registry that can be used to facilitate     research with the ultimate goal of reducing the morbidity and/or mortality and improving the     quality of life of patients diagnosed or living with hairy cell leukemia. With approximately     600 new cases of this rare disease identified in the US each year, HCL represents 2% of all     cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell     Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence,     seeks to develop a registry to help researchers identify new trends in outcomes, recognize     the most effective treatments, discover previously unknown complications of the disease, and     design clinical trials for new therapies.   "
55380|NCT02560870|"     Aim: To compare the efficacy of Aloe Vera and non-alcoholic chlorhexidine mouthwash in the     treatment of Periodontal diseases.      Methods &Material: 32 patients were selected, the following periodontal parameters were     recorded at baseline, and after recording all the parameters at the baseline, Scaling, root     planning, and polishing are done for all the patients participating in the study. Oral     hygiene instructions were given that included brushing twice a day with a soft brush, After 2     weeks, patients in the study, were randomly (Balanced Block Randomization) equal divided into     2 groups;      Group A: mouthwash aloe Vera (Alodent Co. UK) for each patient, Group B: Non-alcoholic     Chlorhexidine (Perio-Kin, Livar CO. Spain) 10 ml by patients routinely washed two times in     one day for about 30 seconds and lasts for 15 days, then every 7 days periodontal parameters,     and at the end of 2 weeks (days 0, 7, 15) clinical changes are evaluated.   "
55381|NCT02560857|"     The study will prospectively determine the clinical utility of non-pathogen specific cellular     immunity assessment using the Quantiferon-Monitor to quantify the degree of     immunosuppression. The investigators will use the results of the assay to predict whether     patients develop opportunistic infections and predict organ rejection.   "
55382|NCT02560844|"     This study will evaluate the prognostic utility of novel ECG markers of electrical     instability in patients with cardiomyopathy.   "
58599|NCT02518568|"     The purpose of this study is to investigate the pharmacokinetics of serum iron after a single     oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency     anaemia.   "
55383|NCT02560831|"     Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia,     rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle     strength and postural balance, however benefits from association with pompage is not known.     This study aims to evaluate the effects of therapeutic exercise on pain, muscle strength and     postural balance in elderly women with knee osteoarthritis. Methodology: Almost randomized     controlled trial, in which were included elderly between 60 and 80 years diagnosed with knee     osteoarthritis, randomized into two groups with 11 participants each. Intervention group held     strengthening exercises for flexors and knee extensors, balance training, and manual knee     pompage for 12 weeks. Control Group received educational lectures. Arthralgia was estimated     by pain subscale of the questionnaire Western Ontario McMaster Universities Osteoarthritis     Index and (WOMAC); muscle strength was assessed by the isokinetic dynamometer HUMAC® NORM     Testing & Rehabilitation System and the postural balance by the Biodex Balance SD postural     stability protocol (Biodex Medical Systems, Inc. New York, USA). The Student t test was used     for statistical analysis.   "
55384|NCT02560818|"     This is a case-control study of molecular diagnostics.      This study requires two steps:        -  The first part of the study will be conducted on a population of 10 women without breast          cancer and, or ovarian family (Healthy Volunteers controls)        -  The second part of the study will be conducted on a population of 50 patients          predisposed to familial breast and, or ovarian cancer compared to 10 controls .      For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL     study, ID-RCB 2009-A00833-54) will be used.   "
56792|NCT02542267|"     The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of     GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral     Artery.   "
55387|NCT02560779|"     The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a     recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with     hepatocellular carcinoma. Up to 18 patients will be treated.      The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular     carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.   "
55388|NCT02560766|"     The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg,     compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome     (RLS) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.   "
55389|NCT02560753|"     The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate     Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will     be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET     imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function     (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959.      An expanded access extension is planed to provide access to study medication to subjects who     have completed the main study and requested continued use.   "
55390|NCT02560740|"     Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often     irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the     hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40     percent of patients undergoing chemotherapy.      American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology     (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN.      PerOx Quench has unique membrane protection and anti-oxidative function as a special food,     that's why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin     for colorectal cancer or gastric cancer chemotherapy.   "
55391|NCT02560727|"     No technique by placing a tube through anus into cecum for whole colon administration. This     study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral     tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.   "
55392|NCT02560714|"     The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to     evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of     SI joint pain symptoms.   "
55393|NCT02560701|"     Using eleven years (2004-2014) of claims data from the largest US commercial health insurer,     the investigators will assess the impact of switching into high-deductible health plans     (HDHPs) on outcomes for patients with bipolar disorder. Patient subgroups will include     patients with and without high medication cost-sharing and vulnerable populations     (racial/ethnic minorities, poor, rural, major comorbidities). Interviews with patients and     caregivers recruited through a major advocacy group will provide further insights into the     policy issues with real-life experiences.   "
55394|NCT02560688|"     This study is being conducted to test the hypothesis that coadministration of clopidogrel     with DS-1040b will be safe and well tolerated. Subjects entering the study will initially     receive a single 12 hour infusion of DS-1040b, to generate data on the effect of DS-1040b     alone. After a wash-out period (to ensure that no DS-1040b is left in the blood) subjects     will receive repeated clopidogrel doses over 5 days to generate data on the effect of     clopidogrel alone. On the sixth day subjects will receive both DS-1040b and clopidogrel, and     the effects will be compared to when the two treatments were given alone.   "
55395|NCT02560675|"     Why does acute post whiplash injury pain transform into chronic pain? Multi-modal assessment     of risk factors and predictors of pain chronification   "
55396|NCT02560662|"     The purpose of this study is to investigate whether a training program with intensified     physical exercise prior to and after surgery for breast cancer enhances postoperative     recovery.   "
55398|NCT02560636|"     PLUMMB is an phase I trial to investigate the safety, tolerability and effectiveness of an     immunotherapy drug called Pembrolizumab used in combination with radiotherapy. The study will     also investigate two different doses of pembrolizumab, starting at 100mg (through an     intravenous drip) and increasing to 200mg for the next cohort of patients, if the first dose     is well tolerated. The patients suitable for this study will be: Group A those with locally     advanced bladder cancer or Group B patients whose cancer has spread from the bladder     (metastatic bladder cancer).      Treatment in the PLUMMB trial will start with a pembrolizumab 2 weeks prior to starting a     course of 6 weeks radiotherapy. Treatment with pembrolizumab will then be given every three     weeks. Patients in Group A will then continue to take pembrolizumab for up to a year unless     they have disease progression or unacceptable side effects in the meantime. Patients in Group     B will continue taking pembrolizumab for as long as needed until they have disease     progression or unacceptable side effects.      Patients will be seen every 3 weeks during treatment and every 3-6 months thereafter. CT     scans will be done every 3 months during treatment and as per usual care (usually 6 monthly)     after the treatment has finished. Patients in Group A will also have a cystoscopy (camera     test) to look into the bladder 3 months after they finish radiotherapy. This is standard care     and would be the same for patients not on a research study.   "
55399|NCT02560623|"     This study will evaluate if the capsule sponge device can detect the presence of Barrett's     Esophagus   "
55400|NCT02560610|"     The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma     control in subjects with severe, refractory eosinophilic asthma.   "
55401|NCT02560597|"     The purpose of this study is to assess the effects of repetitive transcranial magnetic     stimulation (rTMS) as a treatment for Epilepsia Partialis Continua (EPC) or refractory Status     Epilepticus (SE), when standard clinical treatments have failed.   "
55402|NCT02560584|"     The purpose of this study is to investigate if blue light cystoscopy with Cysview improves     detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the     KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if     Cysview and blue light is safe and effective when used repeatedly.   "
55403|NCT02560571|"     The study evaluates pre-operative prediction of the risk for lymph nodes involvement in     endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional)     and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before     surgery.      The sonographic evaluation will include endometrial characteristics and myometrial invasion,     pelvic findings and enlarged lymph nodes.   "
55405|NCT02560545|"     Effective treatment of acute pain, chronic and persistent is the most important concern in     the world today. Although a variety of pain medications including anti-inflammatory     painkillers and opiouids, patients continue to suffer from pain constantly. For over a     century ,International committees studied the issue of cannabis, and almost uniformly     recommended the use of cannabis for various medical applications ,especially those that     include pain treatment.      Despite the widespread use of THC in clinical practice, there are few studies on the efficacy     of THC In a double-blind, randomized trial. In addition, few studies examined the effect of     THC on the experience pain in healthy subjects and most of them did not find an effect on     pain experimental induced by capsain. so checking other models of pain such as thermal pain     and mechanical pain in addition to checking the influence on the regulation of pain will     contribute to understanding the mechanism of action of THC. Understanding the mechanism of     action of THC in relieving pain will lead to predicting who will benefit from this treatment     and direct patients for selection of appropriate medication according to the damaged     mechanism.   "
55406|NCT02560532|"     The purpose of this study is to evaluate the safety and potential therapeutic benefit of use     of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due     to the presence of blood in the space around the brain) in patients who have suffered a     condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of     the brain from a ruptured brain aneurysm   "
55407|NCT02560519|"     Colloid solutions are widely used for volume replacement therapy because of their high     oncotic pressure, which could reduce interstitial fluid shifting. Human albumin is the only     colloid solution of biologic origin with a molecular weight of 60 kDa. As the most abundant     plasma protein, it has physiological importance in the well-being of the endothelial     glycocalyx. Older studies in septic patients, however, did not show any benefit of albumin     over saline solution. Crystalloid solutions, such as Ringer's acetate, do not impair neither     renal function nor coagulation, but their volume expanding effect is questionable.      For several reasons (use of heart-lung machine, systemic inflammation, coagulation     disturbances), patients undergoing cardiac surgery need especially large amounts of fluids.     However, there are no large trials comparing albumin solutions to crystalloid solutions     cardiac surgery.      This double-blinded trial will randomize according to a power analysis 1250 cardiac surgery     patients (=625+625) at Meilahti hospital to use either 4% Albumin or Ringer's acetate     solutions for both priming of the heart-lung machine and perioperative volume replacement     therapy. The primary efficacy and safety endpoint of this study is the incidence of major     adverse events (MAE), defined as a composite endpoint of all-cause mortality, acute     myocardial infarction, acute heart failure or low output syndrome, resternotomy, stroke,     certain arrhythmias, major bleeding, infections compromising post-procedural rehabilitation,     acute kidney injury within 90 days postoperatively. The secondary outcomes are total number     of MAEs, major adverse cardiac events (MACE), perioperative fluid balance, blood product     transfusions, blood loss, acute kidney injury, days alive without mechanical     ventilation/outside ICU/at home in 90 days as well as 90-day mortality. Blood samples for     biochemical analyses will be collected at four perioperative time points.      This trial will provide data about efficacy and safety of 4% albumin in cardiac surgery     patients. The biochemical mechanisms of albumin will be assessed.   "
55408|NCT02560506|"     The goals of this Model System Program are to expand upon and advance the findings and     outcomes of previous and current Model Systems clinical research, to continue to develop and     study the effectiveness of innovative treatment strategies for persons with spinal cord     injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated,     interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI.     In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord     Injury Care System (MRSCICS) model system grant proposal will be accomplished.   "
55409|NCT02560493|"     The goal of the proposed randomized controlled trial is to test the efficacy of exergaming     (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and     obese children.   "
55412|NCT02560454|"     ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as     an intervention for ADHD that targets cognitive deficits, with specific exercises through     intensive training sessions. This intervention is based on principles of brain plasticity and     cerebral functional reorganizations.      Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working     memory training is the most commonly used and studied cognitive training program in clinical     practice and research. It is clear from most studies that Cogmed training program increases     working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive     functions that are not targeted by the program, on ADHD symptoms, nor on academic     achievement.      In addition to this type of intervention multi-factorial program targeting different     cognitive function as Presco also exist but have been less studied.      To address these challenges, this study will follow a randomized and controlled design.      The main objective of this study is to examine the impact of cognitive training in comparison     with a control waiting-list group among children with ADHD on:        1. ADHD symptoms,        2. cognitive functioning,        3. attentional capacities        4. academic achievement.      The second objective is to compare two types of cognitive training a unifactorial program     Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive     functions affected by ADHD.      Long-term effects are examined six months after training. Participants (n=90) will be     randomly assigned to the two experimental group (Cogmed or Presco) or to the control group     waiting list. Participants will be evaluated three time (time 1) just before the     intervention, (time 2) six weeks after the first evaluation, immediately after the     intervention and (time 3) six months after the intervention.   "
55413|NCT02560441|"     The first Part: recruiting untreated ENKL patients with extensive stage I or limited stage II     disease (only referring to patients with the invasion of Waldeyer's ring and cervical lymph     nodes) . Patients are randomly divided into two arms, IPGDP regimen chemotherapy followed by     radiotherapy or radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both     arms are 3 cycles. And the chemotherapy is repeated every 3 weeks..      The second part: recruiting extensive stage II ,stage III-IV, relapsed or refractory ENKL     patients. Patients receive 6 cycles of IPGDP regimen chemotherapy. And the chemotherapy is     repeated every 3 weeks.   "
55414|NCT02560428|"     The purpose of this study is to evaluate approximately eight grants that will test     interventions to improve cardiovascular disease prevention. The investigators will collect     and analyze qualitative data to identify the most effective combinations of intervention     strategies. The investigators will observe grantees and selected practices to understand why     and how those combinations are effective. The investigators will also gather data from the     grantees to assess how effective the interventions are.   "
55415|NCT02560415|"     To meet the required intensive intervention hour for treating children with autism spectrum     disorder (ASD), the investigators developed an automated serious gaming platform (11 games)     to deliver intensive intervention at home (GOLIAH). The major objective of the study is to     test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the     usefulness and acceptability of the gaming platform; (2) how experimental children performed     using the different Imitation and JA games; and (3) whether children from the experimental     group improved significantly more than children treated as usual (control group).   "
57523|NCT02532634|"     The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant     and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving     highly emetogenic chemotherapy.   "
55416|NCT02560402|"     Aim of the present study is to determine whether        1. RRI can predict glomerular hyperfiltration;        2. glomerular hyperfiltration is associated with low renal resistive index;        3. glomerular hyperfiltration/low RRI are associated with accelerated flow in the          sublingual microcirculation;        4. glomerular hyperfiltration/low RRI are related to fluid status as quantified with          bioimpedance analysis.   "
55417|NCT02560389|"     The purpose of this study is to investigate a new use for a medication called levodopa     (L-DOPA). L-DOPA has been approved for use in Parkinson 's disease, but not for Posttraumatic     Stress Disorder (PTSD). L-DOPA is thought to enhance certain cognitive abilities that the     investigators believe may be affected among women with PTSD. It is hypothesized that L-DOPA     may enhance fear extinction learning to a conditioned fear stimulus. If this is true, L-DOPA     may improve outcomes for those undergoing certain types of therapy for PTSD, though that aim     is beyond the scope of this project. Additionally, the investigators are testing whether an     individual's genetic profile affects how well L-DOPA works to enhance cognitive abilities.   "
55418|NCT02560376|"     This is an open-label positron emission tomography/computed tomography (PET/CT) study to     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in     insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq)     68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will     be used to assess the PET/CT images.   "
55419|NCT02560363|"     This is an open-label, randomized, cross over single oral dose study to compare the     pharmacokinetics of different formulations of AZD9977 in Part A and the influence of food in     Part B in healthy male subjects   "
55420|NCT02560350|"     Human adipose tissues were obtained from five healthy adult women who underwent abdominal     liposuction. They were aged 28 to 45 years (mean, 32.15±4.8 years) and had no infectious or     endocrine diseases. Ten millilitres of discarded adipose tissue from the humans was used to     gain the adipose-derived stem cells. In this study, the investigators will evaluate the     potential of a small intestinal submucosa scaffold combined with adipose-derived stem cells     to form an adipocyte-containing hypodermis.   "
55421|NCT02560337|"     Many ovarian cancer patients have been offered different standard cytostatics and gradually     develop chemo-resistance. However, a considerable fraction of these patients are still in     good general health and have a strong wish for further treatment.      Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both     tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be     anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer.      Tocotrienol is a fraction of the natural E-vitamin with several biological effects, including     effect on malignant cells and angiogenesis.      The aim of the study is to investigate whether cabazitaxel and tocotrienol could be     reasonable treatment options in patients with chemo-resistant and refractory ovarian cancer     with regard to effect and toxicity.      In case of progression on cabazitaxel there is an option of crossing over to tocotrienol and     vice versa.   "
55422|NCT02560324|"     This is a randomized, double-blind, placebo-controlled crossover study to test whether a     medication called ramelteon (Brand Name: Remeron) will help smokers quit and whether it     reduces sleep problems that smokers experience during a quit attempt.   "
55423|NCT02560311|"     The aim of this study is to analyze cases of human epidermal growth factor receptor (HER)     2-positive metastatic breast cancer (MBC) of the last 10 years at the University Hospital of     Zurich to assess the efficacy of the treatment with trastuzumab in HER2-positive MBC and to     find out associations between different variables and the outcome. The aim is to find out     probable prognostic factors and patterns of disease progression. Prognostic factors could     optimize treatment approaches and result in a delay of disease progression.   "
55424|NCT02560298|"     This randomized phase II trial studies how well cisplatin and fluorouracil work compared with     carboplatin and paclitaxel in treating patients with anal cancer that cannot be removed by     surgery, has come back at or near the same place as the primary tumor, or spread to other     places in the body. Drugs used in chemotherapy, such as cisplatin, fluorouracil, carboplatin     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet     known whether cisplatin and fluorouracil are more effective than carboplatin and paclitaxel     in treating anal cancer.   "
55425|NCT02560285|"     Over time there is a need to improve old and develop new risk models. Overall the assessment     of mortality risk in cardiac surgery is performed with the use of preoperative risk models.     The use of improved risk models and increased accuracy in the technique of preparing these     mathematical systems does not have a positive impact on the level of prediction, which is     still inaccurate, especially in the considered group of high risk. New models need to be     built not only for a better prediction of mortality risk, if not also to predict morbidity in     the group of patients at higher risk of complications after cardiac surgery procedures.      The aim of this study is:        -  To construct the HiriSCORE to identify patients at higher risk of complications after          cardiac surgery procedures        -  Assessing the impact of pre-, intra- and postoperative period to the prognosis of          morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.   "
55426|NCT02560272|"     The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b     conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been     previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses     of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children     1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1     month apart.   "
55427|NCT02560259|"     The role of referred pain from the retro trochanteric region, in patients with knee pain.     Defining and quantifying this sub group of knee patients in the investigators list of refered     knee patients. Evaluating the effect of treatment. A randomized trial.   "
55428|NCT02560246|"     The purpose of this study is to determine whether diet and the gut microbiome play a role in     spontaneous preterm birth (SPTB), namely delivery of the fetus prior to 37 weeks gestation.   "
55429|NCT02560233|"     The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic     Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating     neural, endocrine, and subjective reactivity to psychosocial stress.   "
55432|NCT02560194|"     Guaiac faecal occult blood testing (gFOBT) consistently demonstrates reductions in deaths     from colorectal cancer of around 16% and gFOBT screening is now routine in all four countries     of the United Kingdom. However, gFOBT has significant limitations and is associated with a     substantial interval cancer rate in the region of 50 %, indicating a severe deficiency in     sensitivity for cancer. Additionally, as the majority of colorectal cancers arise from     pre-existing adenomas, it is important for colorectal screening programmes to detect adenomas     in order to reduce the incidence of the disease as well as the associated mortality. Although     gFOBT does detect some adenomas, most randomised trials have not demonstrated a reduction in     colorectal cancer incidence. Also, FOBT screening tends to under-detect cancers in women and     it is relatively insensitive for rectal cancer when compared with colon cancer.      Single flexible sigmoidoscopy (FS), between the ages of 55 and 65 years, has been shown to     bring about a significant reduction in colorectal cancer mortality. In addition, and most     importantly, after a period of four years a significant reduction in colorectal cancer     incidence was observed. FS does not suffer from low specificity since false positives do not     occur, and there is independent evidence that it is more sensitive than a single gFOBT. In     addition, FS is ideally suited to detecting rectal cancers and adenomas, and it is unlikely     that there would be a gender difference in the sensitivity.      Single FS has not been compared with biennial FOBT and there is no information regarding the     utility of FS in a population that has already been exposed to FOBT screening. It is     hypothesised that offering a combination of gFOBT and FS would provide an enhanced screening     algorithm that would be associated with better outcomes than gFOBT alone. In order to test     this hypothesis a randomised evaluation pilot study of FS screening integrated into the     current gFOBT Screening Programme, will be carried out in those around age 60, as this     appears to be the age at which adenoma prevalence peaks.   "
55433|NCT02560181|"     Radiation therapy is considered a standard treatment option for the management of localized     prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal     salvage therapy. Salvage options available for isolated local recurrence include; temporary     or permanent implantation of radioactive seeds into the prostate, complete removal of the     prostate gland, use of low temperatures to treat the disease (cryotherapy), and high     frequency ultrasound to treat the disease. There are risks of complications associated with     all these treatments, and there is presently no consensus as to which treatment is the best.     The aim of this pilot study is to look at the feasibility and toxicities of whole gland     salvage treatment of the prostate using temporary implantation of radioactive seeds into the     prostate.   "
55434|NCT02560168|"     1. The MyoVista device is capable of detecting surface electrocardiogram signals and          sensitive in detecting coronary artery disease compared to traditional computed          tomography angiography (CTA)        2. Electrophysiological signals at the cellular level of myocardium are related to specific          patterns on the MyoVista device        3. Changes in MyoVista device output and can indicative of future CAD outcomes and need for          revascularization   "
55435|NCT02560155|"     Surgical site infections are a major postoperative complication and are mostly due to     colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or     Propionibacterium acnes. In literature, preoperative decolonization procedures showed a trend     in lowering surgical site infection rates, but especially in orthopedic surgery data is     controversial and randomized controlled trials are lacking. In the main study, the study     investigators aim at performing a controlled prospective randomized interventional trial to     measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on     surgical site infection rates in orthopedic surgery. In an alongside study a controlled     prospective randomized interventional trial to measure the impact of preoperative skin     decolonization of patients undergoing an orthopedic procedure will be conducted.   "
55436|NCT02560142|"     This is a single center non-interventional study in healthy participants for behavioral     assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5     participants and will study the implementation of the behavioral tests and identify potential     issues. Part B will involve 30 participants and will study the test-retest reliability.     Duration of participation for each participant will be 30 days for Part A (28 days screening     period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2     study visits of 2 days each separated by a period of 14 days).   "
55437|NCT02560129|"     Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive     critical illness. However, there is no data regarding long-term follow-up for ICU survivors.     The investigators have begun the implementation of an ICU recovery clinic.      Rationale:      ICU survivors are at high risk for functional, cognitive and psychiatric impairments.     However, methods to mitigate these impairments and improve recovery are lacking. Special     follow-up clinics for survivors of critical illness have been proposed and implemented to     some degree, but are uncommon.   "
55438|NCT02560116|"     The investigators aim to correlate noninvasive pulmonary artery systolic pressure (PASP)     measurements obtained with and without echocardiographic contrast (Optison) during     transthoracic echocardiography (TTE) with those obtained invasively and simultaneously during     right heart catheterization, as the gold standard.   "
55439|NCT02560103|"     Observational study to investigate circadian rhythm patterns   "
55440|NCT02560090|"     Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be     eligible for a clinical research study to improve diabetes self-management and decrease     hospital re-admissions.      The purpose of this study is to compare the effectiveness of three hospital discharge     follow-up methods:        1. standard of care,        2. a nurse telephone intervention (care coordination and education), and        3. an in-home community health worker intervention (care coordination and education).   "
55441|NCT02560077|"     Cashew or Anacardium occidentale L. is a plant in a family of Anacardiaceae. The fruit of     cashew or cashew apple may be consumed fresh, but contains high quantities of tannins     yielding a bitter taste and dry mouth feel. Therefore, it is more often prepared as beverage.     It is rich in carbohydrate and vitamin C. It is also claimed for numerous ailments including     antitumor, antimicrobial, urease inhibitory and lipoxygenase activity. In addition, cashew     apple juice also has excellent anti-oxidant potential. The preclinical data also demonstrated     that cognitive deficit rats induced by cholinotoxin which received A.occidentale or cashew     fruit juice for 2 weeks showed the neuroprotective and cognitive enhancing effects.Therefore,     the potential benefit of Cashew apple juice on physical fitness and psychological fitness of     the middle aged and elderly is focused.   "
55442|NCT02560064|"     Measurement of the small bowel length studied by anatomists, surgeons and radiologists.     Results were highly different among these series. Technical and mechanical factors have major     effects on measures. Investigators decided to reach a standardization for the measurement of     small bowel length.   "
56188|NCT02550171|"     The BioGene bank: Is a centralized collection of human blood samples along with de-identified     (coded) health information, environmental factors, family disease histories and information     from DNA. Limited to the NSLIJHS catchment area.   "
55443|NCT02560051|"     This study is for men who have prostate cancer and have failed local therapy or are not a     candidate for prostatectomy or radiation therapy. The purpose of this research study is to     assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus     chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin,     Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The     drugs used in this study are approved by the Food and Drug Administration (FDA).      Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week     cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the     number of months they receive ADT will be based on their disease. The current standard     treatment is ADT and chemotherapy. What differs in this research study is the cycling and     combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side     effects and are believed to provide maximum benefit.   "
55444|NCT02560038|"     This trial is for people with bladder cancer that has spread. The purpose of this research     study is to see if the chemotherapy combination of gemcitabine and cisplatin plus paclitaxel     is safe and effective treatment for bladder cancer.      Paclitaxel, gemcitabine and cisplatin have all been approved by the United States Food and     Drug Administration (FDA). Gemcitabine and cisplatin is a standard treatment for bladder     cancer. There have been studies that show that paclitaxel and cisplatin have antitumor     activity in bladder cancer. European researchers studied paclitaxel, gemcitabine and     cisplatin (same drug combination in this trial) and found that the combination provided good     disease control and was well tolerated. Investigators are studying the same drug combination,     but at different dosages and schedule.   "
55445|NCT02560025|"     This research study is studying a targeted therapy (a form of treatment that uses drugs or     other substances to identify and attack specific types of cancer cells with less harm to     normal cells) as a possible treatment for high-risk acute myeloid leukemia.      The names of the study interventions involved in this study are:        -  Alisertib / MLN8237        -  Cytarabine / Cytosine Arabinoside        -  Idarubicin / Idarubicin hydrochloride        -  Daunorubicin (Can be used in place of idarubicin)   "
55446|NCT02559869|"     This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers     in people with ALS to expand the understanding of ALS pathology, treatment targets, disease     progression, and anatomical differences between different disease phenotypes. This pilot     project is tailored to produce imaging tools that will allow researchers to conduct future     ALS clinical trials more efficiently which may in turn impact the pace for ALS drug     discovery.   "
55447|NCT02559856|"     This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood     thinners for the treatment of blood clots. Half of the patients will receive apixaban and     half will receive rivaroxaban. The main objective is to determine the feasibility of patient     recruitment and resources required to follow enrolled patients and inform for a larger,     multi-centered trial and to assess which one is safer.   "
55757|NCT02555813|"     This observational program collects data on tolerability, safety and efficacy regarding the     use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine.     Additionally data on dosage that is actually used in these patients will be collected.     Patients who have pancreatic cancer and additional diseases can be documented in this study,     too. Collected data might generate learnings on the optimal use of Abraxane in the daily     routine setting.   "
55448|NCT02559843|"     Introduction: Diabetes mellitus a chronic diseases, is the most common and important     metabolic disease in human. Increased free radicals production due to hyperglycemia produces     oxidative stress which worsens the disease and its complications. Pomegranate juice has     antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the     effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure     and oxidative stress in patients with type 2 diabetes   "
55449|NCT02559830|"     Evaluating the safety and efficacy of Lentiviral Hematopoietic Stem Cell Gene Therapy for     advanced stage of Metachromatic Leukodystrophy and adrenoleukodystrophy.   "
55450|NCT02559817|"     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the     treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.      This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.     Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will     receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria     will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17     years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo     for 4 weeks.      This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well     as other bowel symptoms of IBS-C.   "
55451|NCT02559804|"     To describe the natural history of peripheral neuroblastic tumour presenting with SCI and     evaluate the combined effects of different risk factors on the eventual neurologic and     orthopaedic outcomes   "
55452|NCT02559791|"     The steroid sparing effect of anti interleukin (IL-5) monoclonal antibody has been proven,     but the effectiveness of subcutaneous (SC) compared to intravenous (IV) administration of     these drugs to suppress airway eosinophilia is still under debate. As part of a previous     study, 100mg of mepolizumab were administered subcutaneously to a group of subjects with     prednisone-dependent eosinophilic asthma. Despite this intervention, 50% of the subjects (15     patients participated in this study) had persistently elevated sputum eosinophil counts. The     same 15 patients will be invited to participate in the current study, and if they provide     their informed consent, will receive 2 monthly doses of placebo, followed by 4 monthly doses     of IV reslizumab. The primary outcomes are blood and sputum eosinophils, and the secondary     outcomes include sputum and blood Innate lymphoid cell-2 (ILC2) cells, cluster of     differentiation 4 (CD4+) cells, cluster of differentiation-8 (CD8+) cells, cluster of     differentiation-34 (CD34+), Eosinophil-Basophil cluster cells (Eo/B progenitor cells), forced     expired volume in 1 second (FEV1), asthma control questionnaire (ACQ) and number of     eosinophilic exacerbations. Measurements of the outcomes will be done before placebo, after     placebo and after IV reslizumab. This study design will determine whether IV reslizumab is     effective in suppressing airway eosinophilia in prednisone-dependent patients.   "
56189|NCT02550158|"     This study has the objective to demonstrate that an education program could have a     significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their     disease.   "
55454|NCT02559765|"     This survey will investigate the views of people with progressive MS in terms of     physiotherapy services. In particular the study will examine the proportion of people with     progressive MS on the MS register who use physiotherapy services, how worthwhile they think     it is for them and how they would like their physiotherapy to be delivered. This survey will     also explore how physiotherapy services for people with progressive MS varies across the UK     and what other types of rehabilitation services are currently used by people with progressive     MS.   "
55455|NCT02559752|"     This study will explore neurocognitive performance in pediatric brain tumor patients     receiving proton beam radiation therapy (PBRT). The investigators goal is to gather baseline     neurocognitive testing prior to the completion of the first week of radiation therapy along     with follow-up testing 6-12 months after the completion of radiation and serial annual     testing thereafter. With these data the investigators plan to evaluate the effects of PBRT on     neurocognitive performance as it relates to patients' age at diagnosis, tumor location, and     radiation dose. Modeling studies have demonstrated that PBRT could improve neurocognitive     outcomes, but there is a paucity of prospectively-collected patient data. The investigators     are uniquely positioned to address this important question given the busy pediatric central     nervous system (CNS) tumor service, the delivery of proton therapy at the S. Lee Kling Proton     Therapy Center at Barnes-Jewish Hospital, and the multi-disciplinary research team with     extensive experience into the late effects of therapy as it relates to neurocognition.   "
55456|NCT02559739|"     Deficient sleep duration and sleep disturbances - such as insomnia, sleep disordered     breathing (SDB) and restless legs syndrome (RLS)- are associated with hypertension and     cardio-cerebrovascular morbidity and mortality. Several studies suggest that sleep disorders     are frequent after stroke and detrimental for stroke outcome. However, more prospective     studies in a large unselected sample of stroke survivors are needed to better investigate the     short- and long-term consequences of sleep disturbances on mortality and occurrence of new     cardio-cerebrovascular events. Also their pathophysiological mechanisms and their influence     on stroke recovery should be better understood.      Therefore, the aim of this study is to assess the impact of sleep deficiency and sleep     fragmentation on the frequency of new cerebro- and cardiovascular events and death after     stroke or transient ischemic attacks, and clinical outcome within one and two years after     stroke.      The working hypotheses are that stroke survivors with sleep deficiency and sleep     fragmentation due to insomnia, sleep-disordered breathing or restless leg syndrome will     present: (1) higher mortality from all causes and higher frequency of new cardio-/     cerebrovascular events; and (2) a less favorable clinical outcome. Outcomes will be compared     between patients with and without sleep deficiency and fragmentation.      Since current clinical practice in cerebrovascular patients does not sufficiently consider     sleep disorders in patient's management, this study can help to bring attention to a still     overlooked medical problem and change the current standard of management of stroke survivors.   "
55758|NCT02555800|"     The aim of this study is to compare the efficacy of intralesional bevacizumab, a monoclonal     antibody against vascular endothelial growth factor, versus the antiviral drug cidofovir in     patients with recurrent respiratory papillomatosis.   "
74702|NCT02307968|"     To observe the patient's preference, pain perception, and usability between inner and outer     upper thigh for insulin therapy. To add another injection site for insulin therapy.   "
55457|NCT02559726|"     Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract     gradient of 30 mmHg or more under resting conditions is an independent determinant of     symptoms of progressive heart failure and death.      The investigators hypothesize that the electrical approach by dual chamber pacing could     improve symptoms and reduce outflow-tract obstruction in a specific sub-group of selected     patients with a mechanical hyper-synchronicity. The aim of the study is to identify and     describe this phenomenon in HCM with (O-HCM) and without (NO-HCM) outflow-tract obstruction     thanks to innovative multi-imaging approach.   "
55458|NCT02559713|"     The purpose of this study is to assess the concentration of vedolizumab in breast milk of     lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving     vedolizumab therapeutically.   "
55459|NCT02559700|"     This study is an open trial investigating the long-term use of an online brain training     programme for adults over 50. It will determine whether there is sustained benefit to     cognition, and whether this group can be engaged in this form of intervention over a period     of 12 months.   "
55460|NCT02559687|"     In this study participants with advanced/metastatic adenocarcinoma or squamous cell carcinoma     of the esophagus or advanced/metastatic Siewert type I adenocarcinoma of the gastroesophageal     junction (GEJ) previously treated with two standard therapies will be treated with     pembrolizumab   "
55461|NCT02559674|"     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation     study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with advanced     pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.   "
55462|NCT02559661|"     Operations in the retina and removal of the vitreous (vitrectomy) is a type of operation     where the surgeon requires much training and where there is an increased risk of operative     complications in the early stage. For this reason, virtual surgery is suited to help training     and subsequent maintenance of operational skills [1, 2].      There are no previously published research in virtual vitreoretinal surgery, but this is     nevertheless vital to better surgical training.      Many surgical disorders - such as retinal detachment - progresses with time, and it is often     not known when to ideally operate [3]. On one hand, it may be best to operate early and     thereby reduce the risk of disease progression before surgery. On the other hand, it is also     important to take into account factors such as the presence of the correct operational     expertise as well as the surgeon's fatigue and stress levels. These mentioned matters is     difficult to test clinically. With virtual surgery it will be possible to introduce various     operational distractions and see what impact it has on operating performance.      The purpose of the study 'Virtual vitreoretinal surgery: construction of a training program     and analysis of significant factors for operating performance' is 1) to facilitate the     training of future vitreoretinal surgeons by introducing a virtual training program with high     construction validity, and 2) to clarify which external conditions affects the performance of     trained operator using the virtual training program.   "
55464|NCT02559635|"     Postoperative ileus is the most commonly observed morbidity following ileostomy closure.     Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy     undergoes a series of functional and structural changes. It has been hypothesized that these     changes may contribute to the development of postoperative ileus, and that stimulating the     distal limb of a loop ileostomy prior to closure may functionally prepare the excluded bowel     for intestinal transit.      The purpose of the multicenter, randomized controlled trial is to determine the impact of     preoperative stimulation of the distal limb of a loop ileostomy on postoperative ileus.   "
55465|NCT02559622|"     The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg     secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on     endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in     subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to     evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging     (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel     wall morphometry in atherosclerosis prone vascular beds.   "
55466|NCT02559609|"     Despite recent improvements in the US economy, unemployment remains a significant concern,     and estimates indicate that one-third of unemployed persons drink at hazardous levels,     adversely impacting their health and abilities to find jobs. Reinforcement interventions are     highly efficacious in reducing substance use, and they can be applied to increase job-seeking     activities as well. In partnership with CT United Labor Agency, this project is designed to     reduce hazardous drinking and enhance active participation in job-seeking activities among     those with job loss. It will evaluate the independent and combined effects of reinforcing     negative breathalyzer samples and job-seeking activities to ascertain the simplest and most     cost-effective approach to improving outcomes in this population. Unemployed individuals with     hazardous drinking (N = 280) will be randomly assigned to one of four conditions using a 2 x     2 design: standard care, standard care with reinforcement for submitting negative     breathalyzer samples, standard care with reinforcement for job-seeking activities, or     standard care plus reinforcement for both negative breathalyzer samples and job-seeking     activities. Participants in all conditions will receive usual services part of CT United     Labor Agency, along with a novel remote breath alcohol monitoring procedure. The study     interventions will be in effect for three months, and participants will be followed for one     year. Alcohol and other drug use, employment, psychiatric symptoms, and global measures of     health will be assessed throughout treatment and follow-up. Reinforcing negative breathalyzer     samples is expected to significantly reduce drinking, and reinforcing job-seeking activities     is expected to increase re-employment rates and reduce time until job attainment. Reinforcing     both negative breathalyzer samples and job-seeking activities is hypothesized to improve     outcomes along both domains. The reinforcement interventions may also decrease psychiatric     distress and slow progression of physical decline, common among the unemployed. If     efficacious and cost-effective, results from this study may stimulate adoption of     reinforcement interventions in the context of unemployment services. Reducing the adverse     consequences of hazardous drinking and improving job re-entry may have pronounced benefits in     a highly vulnerable segment of the US population.   "
55467|NCT02559596|"     The purpose of this study is to investigate whether there is an association between stroke or     heart attack and reactivation of varicella zoster virus, measured by antibody levels, using     linked data from the Health Survey for England and secondary care.   "
55468|NCT02559583|"     The primary purpose of the study is to quantify participants' demographic parameters, country     standard therapies, treatment patterns and outcomes among participants with chronic     lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in     oncology concentration hospitals in Latin America.   "
76211|NCT02288273|"     A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared     with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.   "
55469|NCT02559570|"     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the     treatment of functional constipation (FC), in children age 6-17 years This study includes up     to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will     receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid     oral solution.      Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of     linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will     be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.      This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well     as other bowel symptoms of FC.   "
55471|NCT02559544|"     Evaluate [18F]FES PET/CT uptake as a predictor of progression free survival in endocrine     refractory recurrent or metastatic breast cancer patients starting a new therapy regimen     including endocrine targeted therapy.   "
55472|NCT02559531|"     The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in     Switzerland, France and Belgium. No validated triage scale is actually used by Emergency     Medical Service (EMS) providers. The objective of this project is to evaluate the reliability     and performance of triage by EMS providers with the SETS.   "
55473|NCT02559518|"     A crossover trial with healthy volunteers will be conducted. Six sessions will be performed     once a week in a counterbalanced order and at least with seven days washout period to     minimize carry-over effects. In each session, volunteers will be submitted to: fatigue and     attention levels evaluation, cortical brain activity measures through paired pulse     transcranial magnetic stimulation (pp-TMS), handwriting test, non-invasive cerebellar     stimulation during serial reaction time task (SRTT) and performance perception evaluation.   "
55474|NCT02559505|"     This study evaluates how different methods of early exposure to influenza (natural infection,     live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate     immunity and poise the immune system to respond to a future challenge with the inactivated     influenza vaccine.   "
55475|NCT02559492|"     This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid     tumors. The study will be divided into 2 parts (Part 1a and Part 1b). Part 1a will evaluate a     JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor     (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor     (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each     combination. Once the recommended dose has been identified for each treatment group in Part     1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon     prior treatment history with a PD-1 pathway-targeted agent (Part 1b).   "
55564|NCT02558335|"     The purpose of this study is to identify and quantify circulating tumor markers, which are     associated with the presence of tumors. The current imaging available does not allow     specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or     swelling of the tumor after treatment before it shrinks). Our hope is that CTCs will     provide a more accurate description of tumor state for high grade glioma patients.   "
56190|NCT02550145|"     The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial     glucose reductions after bariatric surgery in a subset of patients who have severe     symptomatic hypoglycemia.   "
55476|NCT02559479|"     The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs.     high (35%) protein (mainly coming from animal source) composition on body weight and     carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A     dietary intervention is carried out during 6 months in 100 subjects who are individually     randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35%     protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates.     Around 80% of total protein in diet comes from animal source (of whom around 40% from lean     red meat). Subjects are provided with weekly menus and different recipes to use them as part     of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the     beginning of the study, after 3 and 6 months, the following parameters are determined:     anthropometric (weight, waist circumference, body mass index and body composition), blood     pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total     cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron,     transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine     samples are also collected to assess microalbuminuria and ureic nitrogen.   "
55477|NCT02559466|"     Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for     treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS     efficiency remains however unknown; besides local effect on the target, TMS may induce     interaction changes between remote cerebral regions. On the other hand, few studies have been     performed in comparison to sham placebo stimulation. The investigators recently showed that     non-responder depressive patients to TMS exhibited deeper and wider brain functional     abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device     capable of inducing a magnetic field with a deeper and wider distribution than standard     coils.      The investigators design here a randomized controlled study in which the investigators will     compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their     functional neuroanatomical correlates and changes in connectivity by Positron Emission     Tomography (PET). The general objective is to better understand the mechanisms related to TMS     efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach     for the patient.   "
55478|NCT02559453|"     We have designed this study to determine whether performing two, compared with ≥3 operations     has an effect on key clinical outcomes after discharge from the hospital of an infected wound     that requires admission. Each arm of this study represents the two commonly practiced     standard of care treatment plans for patients presenting with infected wounds. It is     currently unknown which SoC option provides the best patient outcome.   "
55479|NCT02559440|"     The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid     hypertrophy children with severe allergic rhinitis.   "
55481|NCT02559414|"     The proposed study will add to the growing understanding of platelet activity and platelet     inhibition in subjects with HIV. It will examine the relationship between platelet activity     and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy)     in this high-risk cohort. Furthermore, it will provide important data on the mechanism of     platelet activity and its inhibition using biomarkers of platelet activity, inflammation,     immune activity and endothelial function and genetic expression profiling.   "
55482|NCT02559401|"     Currently, standard-of-care tractography is based on information obtained from diffusion     tensor imaging (DTI). DTI is a diffusion magnetic resonance imaging (dMRI) technique that is     routinely obtained on neurosurgical patients to assist in pre-operative planning. The primary     objective of the proposed study is to determine the ability of msHARDI-based tractography to     discern fibers in edematous brain regions.   "
55483|NCT02559388|"     In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic     pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily     activity disorders enroll in this study. These patients should have at least a course of     therapy without proper response. After proper informing patients and taking testimonial     patients enter to study. Then patients randomized in case and control group. In case group,     patients took montelukast 10 milligram daily and in control group took placebo for 30 days.     Other antipruritic or antiinflammatory medication has been stopped one week prior to starting     treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid     Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus     severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score     in beginning and at end of study in both group. Sleep disorder score and its severity added     to crude score at beginning and end of study and change of measures analyzed.   "
55484|NCT02559375|"     This study will increase knowledge of patient preferences for pain treatments, and improve     the ability to meet patients pain management needs. This study will assess patient attitudes     towards underutilized treatments and identify technologies to increase awareness of such     treatments. This study also demonstrate the feasibility of using the Penn Cancer Network in     future clinical and cancer control research and better understand how to effectively raise     patients awareness of supportive cancer services.   "
55485|NCT02559362|"     The goal of the study is to establish the feasibility/willingness of breast cancer patients     to delay surgery to do an exercise program, or be randomized to an exercise training program     following treatment, and to see if that willingness correlates with prior physical activity     history.   "
55486|NCT02559349|"     A pilot, single arm, single center study to determine the feasibility of obtaining stool     samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the     gut microbiota and to obtain preliminary data about possible correlation of baseline     composition and changes in gut microbiota with tumor response, local control, and development     of pneumonitis/other side effects.   "
55565|NCT02558322|"     The study explores the variation in the patient populations and describes regional     differences regarding the reasons for consultations in the primary medical care in Germany.     The data collection will be stratified by rural and urban areas as well as environs. The data     set will include a large variety of data about physicians, patients and health care     utilization.   "
55998|NCT02552641|"     The purpose of the study is assess whether the various forms of triple regimen of     administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and     any independent mealtime) influence the rate of eradication of this bacterium.   "
55487|NCT02559336|"     Advanced cancer patients have a poor quality of life and a high rate of unplanned hospital     admissions. Palliative care has been shown to improve patient outcomes such as quality of     life and symptom burden. Our long-term aim is to study the effect of Supportive and     Palliative Care Review Kit (SPaRK) - a novel model of early palliative care in the acute     hospital inpatient setting. To this end, we propose a pilot study that will provide the     necessary information for the planning of a subsequent larger scale Phase III trial of SPaRK.      The specific aims of this pilot study are: 1) to estimate the recruitment rate and ability of     advanced cancer patients to complete the Functional Assessment of Cancer Therapy - General     (FACT-G) questionnaire, which measures health-related quality of life (QOL) in the four     domains of physical well-being, social/family well-being, emotional well-being, and     functional well-being, 2) to obtain a tentative estimate of the effect size of the SPaRK     model of care on change in patient QOL over 6 days, 3) to explore the responsiveness to     change of FACT-G over 3 days and 4) to explore views of healthcare professionals and     stakeholders on SPaRK as a model of integrated palliative care and oncology care service     delivery.      In the short term, the results from this study will be used to plan a larger scale Phase III     study of SPaRK. In the long term, a resource-efficient and effective model of care needs to     be developed for the aging population and rising palliative care needs of patients. If     successful, this pilot study will lead on to the testing of SPaRK, which does not rely wholly     on specialist palliative care manpower, but involves both specialists and non-specialists     working together to provide palliative care, and hence can be feasibly scaled up across     institutions and extended to non-cancer patients.   "
55488|NCT02559323|"     Cancer survivors face unique health challenges as a result of their cancer diagnosis and     treatment. OncoLink created an Internet based program for survivors to learn about their     risks. A follow up survey will allow us to continue to develop the program in ways that will     benefit users. This survey will need to be conducted via email, which will require the     collection of the users email address and a secure method of linking the users care plan     questionnaire answers to their survey answers.   "
55489|NCT02559310|"     This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment     of adults with moderate to severe community-acquired bacterial pneumonia.   "
55490|NCT02559297|"     This prospective interventional study aims to compare sevoflurane and desflurane anesthetic     agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing     Living Donor Kidney Transplant (LDKT).   "
55492|NCT02559271|"     The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor in     a pediatric population (between 5 and 16 years of age).   "
55759|NCT02555787|"     A study to evaluate changes over time in renal function from baseline (time of conversion) up     until five years post conversion in kidney transplant patients converted from tacrolimus     twice daily (BD) formulations to a once daily formulation as Advagraf.   "
59160|NCT02511184|"     The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum     tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and     anti-tumor activity of the combination.   "
55493|NCT02559258|"     This is a single-center, randomized, double-blind, placebo-controlled, single-dose, dose-     escalation study in otherwise healthy cat-, dust mite-, or Bermuda grass-allergic male and     female subjects. There will be five dosing cohorts (0.1, 0.3, 1.0, 3.0 and 10.0 mg/kg), with     eight subjects in each cohort, randomized to either epsi-gam (6 subjects) or placebo (2     subjects) for a total of 40 subjects. The first cohort will receive the starting dose of 0.1     mg/kg epsi-gam or placebo and subsequent cohorts will be recruited sequentially to receive     escalating doses of epsi-gam or placebo.   "
55494|NCT02559245|"     This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel     syndrome predominant constipation. one-third of patients will receive Ficus carica, another     one-third will receive Descurainia Sophia and remained patients only will follow their     regular diet for 4 months.   "
55495|NCT02559232|"     This is a retrospective observational study to describe the sociodemographic and clinical     characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of     stroke or systemic embolism, who at least three months ago changed their anticoagulant     therapy, due to any clinical situation, and are currently on treatment with a direct oral     anticoagulant (DOAC)   "
55496|NCT02559219|"     Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and     Patient Satisfaction is a pilot project designed to test the feasibility and acceptability of     use of an online care plan generator for adult survivors of pediatric cancers.      Because of improvements in cancer screening, diagnosis and treatment, there are an estimated     13 million cancer survivors living in the U.S. today, with projected growth to 18 million by     2020 (De Moor). These survivors include survivors of leukemia and lymphoma, as well as solid     tumors including breast, colon, testicular and prostate cancers. It also include a subset of     patients who are survivors of pediatric cancers, as over 80% of children diagnosed with     cancer today are cured. In fact, it is estimated that 1 in every 600 young adults between the     ages of 20-35 is a cancer survivor (Dreyer, Hewitt, Greenlee).      Cancer patients as a whole, despite improved cure rates, have been shown to receive     inadequate medical care as survivors. Comprehensive survivorship care should include routine     age appropriate medical care as well as information about prior diagnosis and treatment, and     screening for recurrence of their primary malignancy as well as secondary malignancies, and     screening for late effects of cancer treatment (Earle, Craig). Adult survivors of pediatric     cancer, exposed to life-saving but toxic treatments during times of growth and development,     are particularly prone to late effects but also have been shown to have inadequate monitoring     and follow up. This is a concern as late effects of treatment are sometimes silent for years     or decades after completion of cancer therapy and that adult survivors of childhood cancer,     years from their diagnosis and treatment, have been shown to have alarming rates of life     threatening chronic health conditions compared to their peers (Oeffinger). Thus, these late     effects may emerge during adulthood when patients have moved on from the care of their     primary oncologist. Complicating matters, primary care providers, who often assume the care     of these patients, may not have the knowledge or tools necessary to appropriately care for     survivors of childhood cancer (Suh).      National organizations have come together to identify ways to improve quality of and access     to long term follow up care for adult survivors of childhood cancer. The Children's Oncology     Group published Long Term Follow up guidelines which recommend lifelong risk based follow up     care and screening (COG guidelines). In addition, in 2005, the Institute of Medicine     published a report, From Cancer Patient to Cancer Survivor: Lost in Transition gave     recommendations to improve health outcomes of cancer survivors which includes the receipt of     a comprehensive care summary and follow up plan to aid in appropriate risk based follow up     care (Hewitt). Despite these recommendations childhood cancer survivors knowledge about past     diagnosis and treatment and engagement in follow up care is suboptimal (Kaden-Lottick,     Nathan). It has been demonstrated that pediatric cancer survivors are not receiving care     summaries, and thus may try to find appropriate follow up information via the other sources     such as the internet (Casillas).      Oncolife, a free online tool to create survivorship care plans, was created in May 2007 (Hill     2009), and has been housed at maintained at the University of Pennsylvania since then. This     tool has shown to be feasible way to provide information and care plans to survivors of adult     cancers. In addition, survivors who have used the resource, state that it will, or has     already, positively influenced communication about cancer related follow up with their     healthcare team (Hill 2013).      The study aim is to adapt Oncolife to provide individualized information for adult survivors     of childhood cancer with the unique recommendations for long term follow up for pediatric     cancer survivors. Oncolife has already been collecting data on plans created by adult     survivors of adult cancers and has been reviewed by the IRB previously (IRB#806368 and     #811528 note: previously called Oncolink). Adaption of Oncolife to meet the needs of adult     survivors of childhood cancer will improve access to high quality electronic health     information as patients may find long term follow up guidelines cumbersome or largely     irrelevant to their needs depending on their specific exposures. Individualizing the     available information to a particular survivor will allow for better understanding of and     improved adherence to recommended cancer related follow up care. We propose to develop     survivorship care plans in a way that will most benefit users, thus after creation of the     Smart Adult Living After Childhood Cancer care plan we will ask for patient input via survey     immediately after receipt of their care plan and in a one month follow up survey.   "
55497|NCT02559206|"     The objectives of this study are to evaluate the safety, efficacy, and dose response of two     delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is     DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C).     Additional objectives include understanding how the two DR formulations compare with each     other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of     linaclotide).   "
55498|NCT02559193|"     The Study is a single-arm prospective trial of patients receiving at least one medication     with a known association between genetics and drug metabolism. All patients will undergo     genetic testing as determined by their treating physician. The specific genes tested will, in     general, be based upon the drugs the patients are taking or those that the patient's treating     physician is considering as potential substitutes for current medications.   "
55499|NCT02559180|"     Treatment of diabetic macular edema with intravitreal aflibercept in subjects previously     treated with intravitreal anti-Vegf agents (ranibizumab or bevacizumab)   "
55541|NCT02558634|"     Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological     voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles.     Current treatments such as botox and voice therapy only provide temporary relief and thus,     the investigators are exploring new strategies to provide long-term, sustained improvement.      Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of     electrodes to deliver electrical stimuli to specific brain regions. It is the standard     surgical treatment for many other movement disorders such as Parkinson's disease, essential     tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS     can improve the vocal dysfunction of LD.   "
55542|NCT02558621|"     The main objectives of the study are to evaluate the acceptance into operating flow,     performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery   "
55500|NCT02559167|"     In this study, the investigators seek to evaluate the effects of cannabidiol (CBD) on cocaine     craving and relapse. Cocaine addiction is characterized by compulsive substance use and     repetitive urges to consume the drug even after a sustained period of abstinence. While     substance use remains the most obvious direct outcome of addiction, there is a growing     interest in other core symptoms of this disorder. Craving has become a subject of great     interest as it is a reliable intermediate phenotype of cocaine relapse and a distressing     symptom of addiction associated with suffering. Indeed, even after a period of abstinence,     cocaine-dependent individuals remain vulnerable to stress and other craving-inducing stimuli,     which, in turn, lead to intense physiological responses and various negative feelings such as     anger and sadness. Real-time daily monitoring of craving and drug use has shown that craving     predicts cocaine relapse among cocaine-dependent individuals. In sum, working toward     improving the treatment of craving could not only help prevent relapse, but also reduce     patient distress on emotional, cognitive, and physiological levels. In the past decades,     significant scientific efforts have been deployed toward the development of innovative     strategies to beat cocaine addiction, but with partial success thus far. Psychosocial     approaches have been widely used to help cocaine-dependent patients achieve better outcomes     after drug cessation, but literature indicates that these strategies alone are at times     insufficient to induce significant behavioural changes or a reduction in rates of drug     consumption. Unlike other types of addiction, such as opioid and alcohol, no pharmacological     treatment has yet been found to be truly effective in relieving cocaine-cessation symptoms     like craving and anxiety or to prevent relapse. CBD is a natural cannabinoid with a     favourable tolerability profile and discrete neurobiological actions that are linked to     neural circuits closely involved in addiction disorders. Addiction to cocaine is     characterized by alternating phases of intoxication and short abstinence, followed by     recurrent drug-craving episodes which result in distress and relapse. Our hypothesis is that     CBD a cannabinoid known for its broad spectrum properties is an interesting pharmacological     contender to decrease cocaine craving and treat cocaine addiction. Previous studies conducted     in animals and humans confirm that CBD is a very safe and tolerable medication.   "
55501|NCT02559154|"     To investigate the efficacy of a modified bortezomib based combination therapy for patients     with multiple myeloma.   "
55502|NCT02559141|"     The Nexfin monitoring system offers a complete non-invasive approach to a continuously     estimation of blood pressure, CI and PPV by means of finger-cuff based pulse contour     analysis. Several clinical investigations have proven reliability and interchangeability of     the Nexfin technology yielding acceptable results especially regarding the trending     abilities. At present there is no evidence available, whether a early goal directed     hemodynamic optimization protocol based on a completely non-invasive monitoring technology is     able to reduce postoperative complication. Therefore, the aim of this single-center study is     to compare the clinical outcome and postoperative complications of patients undergoing major     colorectal surgery treated with standard of care or with a GDT protocol based on the Nexfin     technology.   "
55503|NCT02559128|"     The purpose of this cross-sectional comparative 2x2 trial study is to compare the degree of     insulin resistance, myocardial function and selected metabolic parameters and to explore the     pathophysiological mechanisms by which insulin resistance is implicated in development of     chronic heart failure (HF) in patients with type 2 diabetes and prediabetes (T2D).      Investigators hypothesize that patients with heart failure will be insulin-resistant and will     display metabolic abnormalities as patients with diabetes.   "
55504|NCT02559115|"     The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can     show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled     DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study     is being done because there are unmet medical needs to improve the current ways of detecting     prostate cancers before surgery.   "
55505|NCT02559102|"     This is a prospective randomized controlled trial comparing dexmedetomidine sedation with     caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal     herniotomies in neonates and infants below 3 months of age.      The investigators will compare the efficacy and adverse events associated with each of these     techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2     years of age.   "
55631|NCT02557464|"     The objective of this study is to identify early and accurate semantics markers of     Alzheimer's disease (AD) by using two types of methods. First, the investigator will evaluate     semantic processing of patients with AD or related disorders which will be compared to age     matched controls by taking neuropsychological tests. Then, the investigator will analyze the     effect of contextual word predictability on eye movements in reading sentences with the help     of the same participants by using an eye tracker. Both of these methods will be used twice     with a time interval of 6 months.   "
55506|NCT02559089|"     Anti-NMDA receptor encephalitis is the most common curable non-infectious autoimmune     encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed     as other causes of encephalitis. Therefore, it is urgent to establish a database of anti-NMDA     receptor encephalitis in Chinese population. The multi-center, prospective clinical trial of     anti-NMDA receptor encephalitis in China's , combined with Beijing Xuanwu hospital, Beijing     Tiantan Hospital, Beijing Children's Hospital and other hospitals around the country, by     screening the NMDA receptor antibody and summarizing the cases analysis, in order to provide     evidence for clinical diagnosis and treatment of anti-NMDA receptor encephalitis.   "
55507|NCT02559076|"     The aim of the present study was to investigate the potential factors that determine     preschool obesity in Al Ain, United Arab Emirates, and assess the effectiveness of a simple     healthy lifestyle tool: Eat Right Emirates (ERE) adapted from the Ten Steps for Healthy     Toddlers, produced in the UK by the Infant and Toddler Forum.   "
55508|NCT02559063|"     This project seeks to identify neural changes that occur in adults with mild cognitive     impairment (MCI) after engagement in computerized cognitive training. In addition, this     project aims to identify physiological factors that may bolster effects of the training on     cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD).     Understanding how cognitive training protects cognitive function in MCI can contribute to     development of effective interventions to slow progression to AD in individuals at risk,     thereby reducing the significant morbidity and health care costs associated with AD.   "
55509|NCT02559050|"     A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction     and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity     constriction.   "
55510|NCT02559037|"     The purpose of this study is to observe the efficacy and safety of acupuncture and     moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and     mucosal immunity.   "
55511|NCT02559024|"     This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the     immune cell environment within colorectal cancer metastases. The drug will be administered to     patients before surgical treatment.   "
78996|NCT02251847|"     To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus     monotherapy of rosuvastatin in hypercholesterolemia patients   "
55512|NCT02559011|"     Transcatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive     treatment option in patients with symptomatic severe aortic valve (AV) stenosis at     prohibitive or increased risk for conventional open-heart surgery. Recent randomized clinical     trials reported a large treatment effect of TAVI over medical treatment among inoperable     patients and similar or superior outcomes compared with surgical aortic valve replacement in     high to intermediate risk patients. However, atrio-ventricular conduction disturbances and     arrhythmias (in particular atrial fibrillation) before, during or after TAVI remain a matter     of concern as they have important consequences.      The objective of this study is to investigate the incidence, nature and prognostic     significance of AV-conduction disturbances and arrhythmias among patients with severe,     symptomatic aortic stenosis undergoing TAVI before, during and after the procedure using a     small implantable cardiac monitoring system (ICM; Medtronic REVEAL LinQTM).      One hundred patients will be enrolled in this study. Prior to TAVI (at least 4 weeks), at the     time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted under     the skin of the chest under local anesthesia. The device will be interrogated just prior to     readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of     symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on     medical and device treatment as well as clinical outcomes analyzed.      The present study will provide information about the actual incidence and impact of     symptomatic and silent arrhythmias and AV-conduction disturbances among patients with severe,     symptomatic aortic stenosis undergoing TAVI. Specifically, the study estimate the burden of     arrhythmias before TAVI and to accurately determine the incidence of new onset atrial     fibrillation and complete AV-block within 12 months after the procedure. Identifying patients     at risk for AV- conduction abnormalities, atrial fibrillation (AF), and non-sustained or     sustained ventricular arrhythmias may guide future preventive measures, medical treatment and     improve patients outcomes after TAVI.   "
55513|NCT02558998|"     The objective of this study is to 1) evaluate the impact of a novel individualized care     planning/ educational technology (the On Q Care Planning System or CPS) on oncology patient     and provider knowledge, attitudes and beliefs about Non-Small Cell Lung Carcinoma (NSCLC)     clinical trials, as well as 2) to evaluate the impact of the On Q CPS on patient referral to     and enrollment in NSCLC clinical trials.   "
55514|NCT02558985|"     No interventions outside the normal course of patient care. The investigators will be     collecting data at specified points throughout the casting process.      The proposed study will measure lung compliance during the casting process for spinal     manipulation. Research questions include: Is there a quantifiable change in lung compliance     during the casting process? Is there an individual change in lung compliance over time     comparing collection points at each cast change? Is there a change in appearance of     flow-volume loop? Is there a decrease in oxygen saturation from post-induction baseline? The     investigators hypothesize that there is a change in lung compliance and a decrease in oxygen     saturation during the casting process.   "
55515|NCT02558972|"     Vasovagal syncope (VVS, simple faint) is the most common cause of transient loss of     consciousness and represents the acute episodic form of orthostatic intolerance (OI).     Postural tachycardia syndrome (POTS) is the common chronic form of OI. Both are defined by     debilitating symptoms and signs while upright relieved by recumbency. Northera should     therefore improve both sympathetic splanchnic arterial vasoconstriction and sympathetic     splanchnic venoconstriction in POTS and VVS, and may represent an ideal drug to improve the     orthostatic response in POTS and VVS.   "
55516|NCT02558959|"     This study is designed to investigate the effect of second-line irinotecan and capecitabine     versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract     cancer patients.   "
55517|NCT02558946|"     The purpose of this study is to determine if pelvic floor muscle training with a physical     therapist before and after surgery will improve health-related quality of life following     robot-assisted radical prostatectomy.   "
55518|NCT02558933|"     The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in     other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for     cognitive and health related quality of life improvement in Down's syndrome.      The objective is to determine the efficacy of EGCG as a therapeutic candidate for the     improvement of cognitive performance in FAS patients.      Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy     of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An     oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6     months after finishing the treatment.   "
55760|NCT02555774|"     This study evaluates the efficacy of cognitive training in subjects with subjective memory     impairment. The first group will receive cognitive training and lifestyle modification in     combination, the second group will receive only lifestyle modification, and the third group     will receive no intervention.   "
55519|NCT02558920|"     Sugars have been implicated in the epidemics of overweight and obesity. This view is     supported by lower quality evidence from ecological observations, animal models, and select     human trials. Higher level evidence from controlled trials and prospective cohort studies has     been inconclusive. Whether sugars contribute to weight gain or increases in adiposity     independent of their calories and whether important food sources other than SSBs are     associated with a higher risk of overweight and obesity remain unclear. To address the     uncertainties, the investigators propose to conduct a series of systematic reviews and     meta-analyses of the totality of the evidence from controlled trials and prospective cohort     studies to distinguish the contribution of fructose-containing sugars and important food     sources of added sugars (SSBs, pure fruit juice, cakes/sweets, yogurt, cereals, etc) from     that of energy in the development of overweight and obesity. The findings generated by this     proposed knowledge synthesis will help improve the health of consumers through informing     evidence-based guidelines and improving health outcomes by educating healthcare providers and     patients, stimulating industry innovation, and guiding future research design   "
55520|NCT02558907|"     Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal     Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer     will be received an examination oncogériatric   "
55521|NCT02558894|"     A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in     Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.   "
55543|NCT02558608|"     This subject analysis of the influence of the dissociating inferior pulmonary ligament on     pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by     video assisted thoracic surgery. All patients are randomly divided into two groups: group A     and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect     the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior     pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed     between the two groups.   "
55544|NCT02558595|"     The purpose of this study is to observe the effects of niacinamide on markers of kidney     injury, inflammation, kidney cyst growth and kidney function.   "
55522|NCT02558881|"     France is among the countries with a high incidence of colorectal cancer. The prognosis     associated with colorectal cancer is related to the development stage of the disease at     diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate     at 5 years was 90%. It is therefore a major issue of screening is widespread in France since     the end of 2008.      This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and     if positive 2) the realization of an optical colonoscopy examination currently regarded as     the evaluation procedure colon reference. But as part of this organized screening, 13% of     those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the     refusal, virtual colonoscopy may be proposed as an alternative according to the     recommendations of the National Health Authority in 2010. But it has never been assessed as     part of organized screening. Similarly another alternative is recently developed colic     capsule that benefits of development in recent years of the capsule for the small intestine     which has become the gold standard for diagnosis of most diseases of the small intestine     (bleeding occult, diagnosis of unknown colitis...).      Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive     FOBT as part of organized screening and did not realize optical colonoscopy after the usual     procedure and complete recovery. This study aims to answer the question of the place of colic     capsule as part of organized screening. An economic component is integrated to assess, in     terms of health insurance, the cost associated with these two exams, and compare them to the     cost of optical colonoscopy.      The proposed study is an observational study of impact of an alternative screening strategy     for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual     colonoscopy and colon capsule in patients refusing optical colonoscopy.   "
55523|NCT02558868|"     This study is a randomized, open-label, controlled study that will compare the efficacy of     oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for     patients with gemcitabine and S-1 refractory pancreatic cancer.   "
55524|NCT02558855|"     The primary aim of this study is to examine how different physical therapy interventions     affect the resting state and contraction state of a certain abdominal muscle in patients with     low back pain.   "
55525|NCT02558842|"     Brazil ranks 17th among the 22 countries responsible for 80% of tuberculosis (TB) cases in     the world. In 2010, the number of new cases of tuberculosis in Brazil was 71,930 and in 4972     RS. In 2010, Brazil had a disease incidence of 37.6 / 100,000 in 2011 fell to 36.0 / 100,000.     The Rio Grande do Sul(RS)S showed an incidence rate of 46.1 / 100,000 in 2011. The mortality     rate was 2.4 / 100,000 population per year in Brazil and RS.      In Porto Alegre, the incidence rate of all clinical forms of tuberculosis has remained, in     the last six years, around 100/100.000 inhabitants per year, while the coefficient of     pulmonary tuberculosis remained on average 50/100.000 inhabitants to year. Thus, Porto Alegre     holds the 2nd place in Brazil among the capitals with the highest incidence of TB,     classifying the city as high risk 5th. Porto Alegre also has a co-infection TB / HIV from     35.3% one of the highest in the country.      The best strategy to prevent new cases of tuberculosis is to invest in early diagnosis and     effective treatment of existing cases of the disease. As the treatment of the disease     requires daily use of medications for an extended period of time (at least 6 months),     adherence becomes the main determinant of the rate of healing of disease.      There are several factors that contribute to poor adherence and treatment dropout:     alcoholism, illicit drug use, infection with human immunodeficiency virus (HIV Human     Immunodeficiency Virus), low education, unemployment, poor housing and prolonged the     treatment. The irregular treatment and neglect are the major obstacles to the control and     elimination of this disease.      Study in Porto Alegre pointed alcoholism, TB / HIV, the fact that the patient does not reside     with family and low education as predictors of dropout. The dropout rate in the general     population of patients with active tuberculosis was 10.7% (8.0% - 17.0%). Abandonment     occurred more often within the first three meses8.      In Porto Alegre, 32.5% of new TB cases are diagnosed in hospitals. Twenty percent of these     patients do not bind, after discharge, the Tuberculosis Control Program (TCP), ie, the     patient egress from the hospital does not reach the basic health unit (BHU) reference for     further monitoring and treatment, which is considered a serious flaw in the process control     of the disease.   "
55526|NCT02558829|"     The Macimorelin-GHST (growth hormone stimulation test) will be compared with the ITT (insulin     tolerance test) in an open-label, randomized, 2-way crossover Trial. The trial will include     subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy     control subjects.   "
55527|NCT02558816|"     This is an open label, multicenter, fixed dose and dose escalation, phase I/II study.      The study will be conducted into 3 steps. The first one will be to ensure the safety of the     combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses in patients with relapsed or     refractory Mantle Cell Lymphoma (MCL).      A total of 9 patients will be included in this first step (step A) with grouped inclusions of     three patients (a safety evaluation will be performed at each inclusion of 3 patients).      The second step (step B) will be conducted if no unacceptable toxicity is observed during the     first step and 24 new patients will be included in the step B. The aim of the second step is     to determine the MTD of the GDC-0199 in combination of GA101 and Ibrutinib (both respecting     the previous doses) by using a Continual Reassessment Method.      The third step (step C) will be conducted if no unacceptable toxicity is observed during the     second step. The aim of the third step is to confirm the safety profile of the combination of     GA101 + Ibrutininb + GDC-199 at dose determined according to step B result in patients with     untreated Mantle Cell Lymphoma (MCL). 15 patients will be included in this step.   "
55528|NCT02558803|"     Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care     provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses     of HPV vaccine for eligible male and female adolescents who have initiated vaccination.   "
55529|NCT02558790|"     This study is a 12-week, open-label pilot study to test the effects of MMFS-201-301 on     cognition and function in adults with ADHD. Subjects may enter the trial on a stable dose of     medication for ADHD, and MMFS-201-301 will be given. Subjects who do not enter on a stable     dose of ADHD medication will receive MMFS-201-301 alone.   "
78624|NCT02256735|"     Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the     ECG in comparison to placebo and moxifloxacin   "
55530|NCT02558777|"     Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial     (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and     severity of delirium in hospitalized older adults in an AGU.      Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU     Complejo Hospitalario Universitario from Albacete (Albacete, Spain).      Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29     control group).      Interventions: After risk factor analysis, all participants in the intervention group (IG)     received a daily multicomponent intervention (orientation, sensorial deficit, sleep,     mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the     intervention nurses. The control group (CG) received usual care.      Measurements: Delirium presence was determined daily with the Confusion Assessment Method     (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days     of hospitalization, use of physical restraint measures, and use of drugs for delirium control     (neuroleptics and benzodiacepines) were also recorded.   "
55592|NCT02557971|"     This study is a retrospective chart review of patients treated with BOTOX® for idiopathic     Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine     the rate of post procedural urinary retention requiring catheterization and identify factors     that may predict urinary retention.   "
55593|NCT02557958|"     Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.   "
55531|NCT02558764|"     Advances in surgical techniques and immunosuppression (IS) have led to an appreciable     reduction in postoperative complications following kidney transplantation. However, surgical     site events (SSE) including surgical site infections (SSI) and other wound complications are     still very common and they can limit these improved outcomes and result in prolonged     hospitalization, hospital readmission and reoperation, consequently increasing overall     transplant cost.      Negative pressure wound therapy (NPWT) is a concept introduced initially to assist in the     treatment of chronic open wounds. This technique uses a negative pressure unit and specific     dressings that help to hold the incision edges together, redistribute lateral tension, reduce     edema, stimulate perfusion and protect the surgical site from external infectious sources.     Thus, it provides faster wound healing and shortens hospital stay.      Recently, there has been growing interest in using portable NPWT devices on closed incisions     after surgery to prevent potential SSI and other wound complications in high-risk patients.     Investigations regarding this technique in various surgical settings have shown that it can     reduce the risk of SSI and other wound complications. These studies concluded that any     patient undergoing transplantation should be considered as 'high-risk' and should receive     this treatment.      To date, no studies are reported in literature exploring the effects of preventive use of     portable NPWT devices on surgical wounds in the setting of organ transplantation. The aim of     our study is to compare a portable NPWT device (PICO, Smith & Nephew, London UK) to     conventional gauze dressings in patients undergoing kidney transplantation (KT) surgery.   "
55532|NCT02558751|"     The investigators hypothesized that vaccination with either the 23-valent pneumococcal     polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV 13)     followed by PPV23 results in similar antibody levels/functional activity and induce a similar     pneumococcal polysaccharide (PPS)-specific B cell response in HIV-positive individuals >50     years of age and HIV-negative persons>50 years of age. The investigators immunized the study     group HIV+ persons>50 and controls (HIV negative >50 years) with PCV13 followed by PPV23 and     HIV+>50 with PPV23 alone. The investigators examined immune responses to PPS23F and PPS14 on     a quantitative and qualitative level using ELISA and opsonophagocytic assays (OPA).      To test the hypothesis that the levels of antigen specific B cells identified with PPS were     comparable between the PPV23 and PCV13 vaccine recipients. Pre- and post-immunization     peripheral blood samples were obtained. Extensive B cell phenotype analysis using fluorescent     antibodies was used to characterize PPS-labeled B cells. Specific phenotypes were correlated     with antibody levels and OPA and compared to historic populations immunized with PPV.   "
55533|NCT02558738|"     In this observational study, insights regarding the tolerability and influence on the quality     of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall     be gained under real life conditions in patients with chronic eczematous irritations and     pruritus of the outer ear canal.   "
55534|NCT02558725|"     Since normal pregnancies are associated with dilutional anemia, due to a greater increase in     plasma volume with a smaller increase in RBC mass, it is important to properly diagnose IDA     according to the levels of serum ferritin. Previous studies examining the optimal iron dose     have shown that adjustment of iron supplementation according to serum ferritin levels in     early pregnancy could be beneficial. Nonetheless, there is no consensus regarding the     appropriate dose of iron during pregnancy, its dose-response curve and its effect on serum     ferritin levels.      In this trial the investigators sought to assess the efficacy of doubling the daily iron     supplement dose in pregnant women with IDA.   "
55535|NCT02558712|"     The purpose of this study is to compare the Technology-based Eye Care Services (TECS)     protocol to the standard face to face ophthalmologic exam.   "
55536|NCT02558699|"     Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal     atrial fibrillation. In order to reduce the recurrence rate after catheter ablation, we     propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial     computer model. We will conduct virtual rotor mapping in the patient specific atrial model.     Then, we will compare the clinical outcome of conventional circumferential pulmonary vein     isolation and additional rotor ablation guided by virtual rotor mapping.   "
55537|NCT02558686|"     Application of trigger point dry needling can induce post-dry needling soreness. This is not     a negative experience, but sometimes some patients want to reduce it as much as possible.     Manual therapies and exercise strategies targeting to decrease post-dry needling soreness     need to be investigated.   "
55538|NCT02558673|"     The purpose of this study was to understand the production of trimethylamine-N-oxide (TMAO)     and its metabolites from dietary precursors found in fish, eggs and beef. In addition, this     study traced the fate of supplemental TMAO that has been labeled with deuterium to determine     how TMAO is being used in the body.   "
55539|NCT02558660|"     The purpose of this study is to evaluate the impact of a brief clinic-based educational     intervention on utilization of Double Up Food Bucks (DUFB)—a Michigan-wide Supplemental     Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center     patients at a community health center in Southeast Michigan.   "
55761|NCT02555761|"     This post-marketing surveillance study will assess the safety and efficacy of Lastacaft®     Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with Allergic     Conjunctivitis as prescribed as standard of care in clinical practice in Korea.   "
55540|NCT02558647|"     This first aim of this study is to evaluate the effect of a cost-effective, more accessible     alternative treatment approach for insomniacs. Traditional CBT-I has been adapted to an     online intervention system, so individuals can access a personalized treatment when they     want. This newly developed web-based computer technology has produced remarkable preliminary     results, comparable to the results one can achieve when delivering CBT-I in a face-to-face     format. The current project will test this approach for use on a population scale. Of the 13     500 participants reporting symptoms of insomnia in HUNT3, 1500 will be randomized into CBT-I     or a placebo control group. The large scale of this trial will allow detailed analyses of     subgroups (insomniacs with comorbid conditions), which has not been possible in the previous     small clinical trials. The upcoming HUNT4 in 2017-2018 will together with data from FD-Trygd     provide unique long-term FU-data on both a range of health parameters and employment status.     The second aim is to use the HUNT3 Biobank to examine how genes may be related to insomnia.     Our study will also be the first of its kind to examine if genes may predict the outcome for     individuals in the treatment study.   "
55545|NCT02558582|"     Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated.     Advances in medical therapy have improved survival according to recent registries and     systematic reviews, but are associated with high healthcare costs.      Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise     training on improving exercise performance, quality of life and pulmonary hemodynamics in     patients with pulmonary hypertension.      The main objectives of the present project are:        1. to investigate the quality of the implementation of a standardized 3 week in-hospital          exercise training program on markers of outcome and disease severity in PH-patients in          Switzerland immediately after training and after 3 and 12 month.        2. to look whether training with hyperoxia vs. standard care might be more effective.      This is a multicentre, randomized parallel-group trial where the intervention rehabilitation     is delayed in one group so that they can serve as standard care controls for the others.      In a nested single-centre randomized-controlled trial patent will additionally be randomized     to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental     oxygen therapy (SSOT) during nights and ergometer training.      Patients will receive a PH specific rehabilitation program during 3 weeks followed by an     instructed home-based training program for 12 weeks. Patients who are not already under     long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to     receive standardized supplemental oxygen therapy (SSOT) during training and nights upon     written informed consent.   "
55546|NCT02558569|"     This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor     patients. The control group will receive standard general anesthesia with the use of fentanyl     for intraoperative pain control and the study group will receive scalp nerve block with 0.5%     levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The     scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general     anesthesia.   "
55547|NCT02558556|"     Rationale: Several clinical feasibility studies have shown the potential benefit of     near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) for enhanced and     earlier biliary anatomy visualization during laparoscopic cholecystectomy with the aim to     reduce the number of vascular and biliary injuries. Although the incidence of injuries is low     (0.7%), the impact on patients in terms of morbidity, quality of life and costs are dramatic.     The Critical View of Safety (CVS) technique is regarded as the safety valve in conventional     laparoscopic cholecystectomy (CLC). It is hypothesized that standard application of     near-infrared fluorescence imaging during laparoscopic cholecystectomy can be useful to     obtain establishment of CVS (at least 5 minutes) earlier and with more certainty regarding     visualization when compared to conventional laparoscopic imaging alone.      Study design: A multicenter randomized controlled trial with two study arms. Patients     scheduled for an elective laparoscopic cholecystectomy will be recruited and randomized at     the outpatient clinic (n = 308 total). One group will undergo near-infrared fluorescence     cholangiography assisted laparoscopic cholecystectomy (NIRF-LC) and the other group will     undergo conventional laparoscopic cholecystectomy (CLC).      Compared with standard care, patients in the NIRF-LC group have to receive one preoperative     intravenous injection of ICG. This is the only additional minimally invasive action for the     patient. Initially, patients participating in this study will not benefit from the     application of NIRFC during the surgical procedure. The administration of ICG and the     modified laparoscope itself are not related with any kind of additional risk for the patient.      Despite the encouraging results from several (pre)clinical feasibility studies, wide clinical     acceptance of the routine use of ICG fluorescence laparoscopy is still lacking due to the     absence of reliable and validated clinical data. A randomized clinical study is desirable to     assess the potential added value of the NIRF imaging technique during laparoscopic     cholecystectomy. Strong evidence in favor of routine implementation of this new imaging     technique during laparoscopic cholecystectomy, will probably lead to worldwide routine     application of the NIRF technique. Therewith long term sustainability of this research     project is guaranteed.   "
55653|NCT02557178|"     Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to     motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete     home exercise as part of pulmonary rehabilitation (PR). The proposed system has two     components: home-based activity monitoring and health coaching. The investigators will     conduct a randomized, wait-list controlled clinical study to evaluate the effects of the     activity monitoring system and health coaching on quality of life and daily steps.   "
55548|NCT02558543|"     Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an     alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are     frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis.      . The injection of adipose autologous tissue is a common practice in plastic surgery, and has     been known for over a century. Adipose tissue, originally used to increase volume, is also     characterized by trophic properties associated to stromal vascular fraction (SVF), which     contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can     be angiogenic and anti-inflammatory, which could improve damage seen with SSc.      A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed     the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of     twelve patients to be proven.      The encouraging results have encouraged us to propose a trial which would bear on a higher     number of patients and include a control group.   "
55549|NCT02558530|"     The major adverse health consequences of obesity occur only when non-alcoholic fatty liver     disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of     triglycerides and other lipids. The first-line approach to NAFLD management is caloric     restriction and weight loss, but these remain difficult to achieve. Little attention has been     given to dietary carbohydrate restriction, despite recent reports showing that hepatic de     novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the     postprandial state, accounts for approximately 25% of liver triglyceride content in     hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides     were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized     30% fat diet for four days before being assessed.   "
55550|NCT02558517|"     Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The     aim of this study was to study the possibility of corticosteroids interruption in patients     with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.   "
55562|NCT02558361|"     Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic     arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works     in the laboratory, there are very few demonstrating how it works in the actual target organ,     i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.      Laboratory data has demonstrated that apremilast decreases inflammatory proteins and     increases anti-inflammatory proteins. However, almost all of these data/studies have been     performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or     synovial (joint) tissue. These studies that have been performed on the blood of patients with     this condition may, or may not, reflect the true response to therapy in the synovial (joint)     tissue and/or skin.   "
55551|NCT02558504|"     First intent treatment for superficial circular esophageal neoplasm is surgical resection.     Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal     stenosis (higher than 80%).      Surgical limits are related to a high level of morbidity due, in particular, to respiratory     complications or infections that require prolonged hospitalisations, and by significant rate     of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative     technique to remove esophageal circular preneoplastic and neoplastic lesions has been     developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which     incorporates approximately 100 electrodes on its surface that emit radiofrequency waves     (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration     of the electrical impulses, it is possible to obtain a homogenous and controlled destruction     of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements     underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna     4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than     half of the circumference of the esophagus and that requires surgical treatment. The expected     benefit for the patient is linked to the reduced invasiveness of the technique in comparison     to the surgery   "
55552|NCT02558491|"     The purpose of this study is to demonstrate the safety and feasibility of a decision support     system aimed at reducing glucose variability in T1DM patient using an insulin pump.   "
55553|NCT02558478|"     Next Generation Sequencing (NGS) strategy is a powerful tool to identify genes implicated in     very rare diseases for which the previous genetic explorations remain negative to date. The     aim of this project is based on groups of patients with original clinical phenotypes     including neurosensory impairment without genetic cause identified to date. The investigators     will study these families using whole exome sequencing to potentially identify new genes and     new underlying biological pathways involved in neurosensory diseases.   "
55554|NCT02558465|"     The objective of this investigation is to assess safety and effectiveness of Xarelto under     practice routine use in VTE secondary prevention after acute DVT, focusing on     hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This     study is a company sponsored, one- arm prospective cohort study with patients to whom     Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard     observation period (1 year) and an extension survey period (2 years, at the longest).   "
55555|NCT02558452|"     SENIOR transplant Registry European transplant registry of senior renal transplant recipients     (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily,     mycophenolate and steroids to investigate long term outcomes on an observational basis.   "
55556|NCT02558439|"     The purpose of this study is to evaluate the safety and efficacy of a single injection of     CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.   "
55557|NCT02558426|"     Chronic Venous Disease (CVD) is a very common problem affecting western adult population. To     date the pathophysiology of CVD development encloses several theories such as the role of     extracellular matrix (ECM) components alterations, the alteration of Matrix     Metalloproteinases (MMPs) and other related molecules, the endothelial dysfunction, and     several genetic factors but none of these could properly explain its genesis. Estrogen     Receptors may be involved in CDV pathogenesis. Endogenous estrogens are important regulators     of vascular homeostasis and they act mainly via three different ERs which are expressed in     the cardiovascular system: ERα, ERβ, and a G protein-coupled estrogen receptor termed GPER.     of this study is to explore the expression of estrogen receptors in vessel wall of varicose     veins through the entire clinical spectrum of CVD.   "
55558|NCT02558413|"     This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1     clinical trial to determine the safety and tolerability of BTA-C585 administered orally to     healthy subjects.   "
55559|NCT02558400|"     To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to     Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.      Following completion of the Month 12 study visit procedures, subjects will be offered the     opportunity to participate in a 2-month observational (i.e., non-interventional) trial     extension.   "
57442|NCT02533687|"     With this study, it is aimed to compare the operative results and complication rates in     transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different     bipolar and a monopolar energy sources.   "
55560|NCT02558387|"     Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in     patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR     might be important role in salivary gland cancers. Accordingly, several trials with various     anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in     salivary gland cancer are ongoing.      Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor     (PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in     initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the     target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo     nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg,     leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts of     a broad range of differing human tumors.      Based on this background, in this study, the investigators would like to conduct a phase II     study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland     cancer of the head and neck to evaluate efficacy and safety.   "
55561|NCT02558374|"     To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic     Solution compared to Timolol Maleate Ophthalmic Solution.   "
55563|NCT02558348|"     The purpose of Part 1 (Phase 1b) is to evaluate the general safety and tolerability of     repeated 21-day cycles of AL3818 therapy, and to reevaluate the maximum tolerated dose (MTD).      The purpose of Part 2 (Phase 2a) is to evaluate the efficacy of repeated 21-day cycles of     AL3818 therapy preliminary efficacy of AL3818 in subjects with recurrent or metastatic     endometrial, ovarian or cervical cancer.   "
55594|NCT02557945|"     The purpose of this study is to test the effects of the drug gabapentin on brain function     thought to be important in the development of schizophrenia. Researchers think that treating     a brain region with gabapentin (the hippocampus) may reduce the risk for developing     schizophrenia.   "
55566|NCT02558309|"     The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial     pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health has been an     area of concrete research effort in recent years. The ability to acquire non-invasive and     highly detailed information on both the eye and the brain using technologies such as magnetic     resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess     non-invasively the effect of ICP in-vivo. In this study, we will quantify the structural     changes in the ONH in subjects with elevated ICP while they are treated to reduce the     elevated pressure. This process will occur in a stepwise fashion over a period of time     determined by the clinical treatment plans. We will apply controlled pressures to the eye     during each step of ICP lowering while OCT images are obtained.   "
55567|NCT02558296|"     The purpose of this study is to investigate the effect of bexagliflozin in lowering     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased     risk of cardiovascular adverse events.      The data from this study will be combined with the data from other bexagliflozin studies in a     meta-analysis of CV safety outcomes.   "
55568|NCT02558283|"     This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in     Chinese adults with nasolabial folds.   "
55569|NCT02558270|"     Inhibition of SGLT2 by specific inhibitors has been shown to reduce the renal threshold for     glucose excretion in patients with type 2 diabetes mellitus (T2DM) and control subjects     leading to significant renal glucose loss even in the presence of normal glucose     concentrations. SGLT2 inhibition with canagliflozin induces a 24h urinary glucose loss of     around 70g in healthy subjects.      Recent studies indicate that under fasting and postprandial conditions administration of     SGLT-2 inhibitors leads to increase in endogenous (hepatic) glucose production (EGP)     potentially counteracting the glucose lowering potency of these drugs. Dapagliflozin has been     shown to acutely increase endogenous glucose production (EGP) and plasma glucagon     concentrations under postabsorptive conditions within 2 hours after drug ingestion in     patients with (T2DM). Glucagon binds to receptors in the liver and activates hepatic     gluconeogenesis (GNG) and glycogenolysis, likely contributing to the observed increase in     EGP.      So far the likely interrelation between acute changes in hepatic glucose metabolism and     energy turnover contributing to increased hepatic glucose production induced by SGLT2     inhibition has not been studied. It is known that out of the 80% of oxygen consumption     coupled to ATP synthesis, 7- 10% is used by GNG. However, so far the effects of dapagliflozin     on acute changes in gluconeogenesis (GNG) and ATP turnover in hepatic tissue and on the time     course of hormones involved in hypoglycaemia counter regulation have not been studied.   "
55654|NCT02557165|"     Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary     disease (COPD) and can affect both respiratory and peripheral muscles. Impaired muscle     regeneration is thought to be implicated in the process of muscle atrophy. In this study the     investigators will evaluate muscle regenerative potential of the Vastus Lateralis (VL) and     diaphragm of patients with COPD, compared to patients with normal lung function.   "
76810|NCT02280434|"     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     CBP-307 following oral single and multiple escalating dose administration in healthy     subjects.   "
55570|NCT02558257|"     Objectives:      Primary Objective The primary objective is to determine patients' perceptions of the     timeliness of their referral to an outpatient palliative care clinic.      The secondary objectives are to determine:        1. The factors and variables associated with perception of timeliness such as age, gender,          and symptom distress        2. The patients' perceptions of the physical environment of the outpatient clinic at UT MD          Anderson Cancer Center (UTMDACC) such as lighting, music, and lack of a waiting room;          and        3. If there is an association between level of distress (physical, psychological, and          spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and the          usefulness of the referral to palliative care center.   "
55571|NCT02558244|"     The aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with     neuroblastoma, at the time of their initial presentation, as a prognostic factor for     prediction of subsequent outcome & complications related to surgery, in the accordance with     the experience of South Egypt Cancer Institute (SECI), which is the largest referral site in     Upper Egypt.   "
55572|NCT02558231|"     The objective of this clinical trial is to compare the efficacy and safety of an initial     triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral     treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve     patients with pulmonary arterial hypertension.   "
55573|NCT02558218|"     Primary objective of the study is the assessment of the patients' discomfort and ocular     redness following cataract extraction surgery by means of phacoemulsification and intraocular     lens implantation.   "
55574|NCT02558205|"     The purpose of this study is to see if it is possible to establish a relationship between the     blood flow and blood volume of liver tumors from CT body perfusion and the radiation dose     deposited in the tumors from the radioembolization treatment as measured by PET/CT.      The study will do this by:        1. Measuring the blood flow and blood volume of tumors in the imaging data from a CT body          perfusion        2. Measuring the radioactivity in the tumors after the radioembolization treatment using          PET/CT and then calculating the dose deposited in the tumor        3. Using statistical analysis to assess the relationship between the dose and the perfusion          parameters      In addition, the research may help develop a method for calculating the dose of     radioembolization to be delivered to a liver tumor(s) using blood volume and blood flow data     obtained from the CT body perfusion scans.   "
55595|NCT02557932|"     In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple     therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for     H. pylori.   "
55596|NCT02557919|"     This project proposes to evaluate the effectiveness of training Head Start staff to discuss     tobacco use, shs reduction and cessation in their existing encounters with parents in     reducing tobacco use and exposure. Understanding the facilitators and barriers to integrating     the intervention into the Head Start system will support future efforts to address tobacco     use and exposure in families with small children.   "
79319|NCT02247648|"     The investigators hypothesize that the use of tramadol will reduce pain and analgesic     consumption after arthroscopic shoulder surgery.   "
55575|NCT02558192|"     Nosocomial infections are infections that occur from the time of 'entry in the hospital up to     48h after discharge. In most developed countries, the incidence of nosocomial infections in     children is between 5% and 44% with the predominance of respiratory infections and     gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce     the effectiveness of treatment, significantly increasing hospital costs. Current measures for     prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with     sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the     possible methods of prevention, between which has been already tested the use of probiotics     such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against     placebo, noted a significant reduction in the risk of gastrointestinal infections and     respiratory infections in hospitalized children treated with LGG, compared with patients who     received placebo. There are also evidence which demonstrate a potential role zinc in reducing     the incidence of respiratory infections is that bowel. We thought, therefore, to perform a     multicenter randomized controlled trial with the aim to evaluate the role of a complex     containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and     respiratory tract infections in pediatric wards.   "
55576|NCT02558179|"     This study is designed as a prospective evaluation of the diagnostic performance of the     multiplex nucleic acid-based genetic test (Gynecologene Next-Generation Sequencing test) to     identify known significant causative organisms in bacterial vaginosis/vaginitis and other     major pathogens and normal commensals in symptomatic women during the reproductive years.     Vaginal fluid samples will be split and tested with the comparator methods and Nugent score,     with the results evaluated according to sensitivity, specificity, positive predictive value,     and negative predictive value. Laboratorians performing each test will be blinded to the     clinical history and any prior test results to minimize ascertainment bias.      Each subject will be followed routinely for up to 6 weeks after initial visit for     vaginosis/vaginitis by telephone or office visit at the discretion of the treating physician.   "
55577|NCT02558166|"     This study consists of two substudies.      The first substudy:      'Renal resistive index in critically ill patients with cardiogenic and septic shock'      Design: cross-sectional observational      Aim of this project is:        1. to determine whether critically ill patients with cardiogenic and septic shock have an          elevated Renal Resistive Index and        2. to determine whether Renal Resistive Index differs between cardiogenic/hypovolemic shock          and shock due to sepsis/systemic inflammation (SIRS)        3. to determine the relation between the (change in) renal vascular resistance and             -  Markers of the systemic - and the microcirculation             -  Fluid status as quantified by bioimpedance analysis             -  Concomitant renal function      The second substudy:      'Predictive value of the Renal Resistive Index on ICU admission and its course for the     development of acute kidney injury in critically ill patients with cardiogenic and septic     shock'      Design: longitudinal observational      The aim of this project is:        1. to determine whether the renal resistance index on admission to the intensive care unit          can predict the development of acute kidney injury (AKI) in critically ill patients with          shock        2. to investigate if the renal resistance index on admission to the intensive care unit is          an independent predictor of the development of AKI or depends on the severity and          duration of shock and other known risk factors of AKI such as comorbidity and use of          nephrotoxic drugs      Aim of the large research project is to determine whether the Renal Resistive Index could     become a monitoring tool for intervention studies aiming to prevent acute kidney injury or     protect the kidney.   "
55578|NCT02558153|"     A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus     standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients     with haemodialysis access stenoses.   "
57472|NCT02533297|"     The aim of the current study was to develop a criterion in terms of the number of sessions     required to achieve mastery in DCS based on the learning curve assessment in real clinical     situation.   "
55579|NCT02558140|"     This first-in-human study consists of three parts. The primary purpose of Part 1 is to     characterize the safety and tolerability of RO6874813 in participants with locally advanced     and/or metastatic solid tumors whose disease has progressed despite standard therapy or for     whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or     recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of     RO6874813 will continue to be characterized in participants with locally advanced and/or     metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In     addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and     paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of     RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.   "
55580|NCT02558127|"     The combination of asthma and being a carrier of genetic variants (mutations and / or     polymorphisms) in the CFTR gene variant would cause bronchial asthma with mucus     hypersecretion. This phenotype is characterized by a more severe disease, in terms of     control, quality of life, exacerbations and lung function, and a different asthma the     bronchial hypersecretion without inflammatory phenotype.   "
55581|NCT02558114|"     The purpose of the study is to compare the efficacy, safety and recurrence rate of two     therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute     hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the     viremia within 4 weeks of the start of treatment (12 vs 24 weeks).      The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing     dose adjusted to renal function, plasma levels of drug and hemoglobin.   "
55582|NCT02558101|"     This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung     cancer screening lung health check appointment. Patients will be individually randomised     (1:1) to receive either control invitation materials or intervention invitation materials.     Those who attend will undergo a lung health check and be invited to a baseline screening     scan if eligibility criteria are fulfilled.   "
55583|NCT02558088|"     The objective of the study is to help establish a urinary threshold for salmeterol on the     World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in     competitive sports.      Hence, there is no hypothesis as such.   "
55584|NCT02558075|"     Large scale, effective, low-cost, and evidence-based programs that can nimbly translate new     research discoveries into prevention and care for psychosocial based problems are urgently     needed. This study hopes to provide support for Mood-Lifters, a template for a low-cost     evidence based program, so that investigators may fill this gap and relieve suffering for     millions of people who are not getting adequate mental health care. Mood-Lifters provides a     low cost, research based program designed to enrich people's lives and reduce psychological     distress. It is designed to provide useful support, coaching and information. It seeks to     help people enhance pleasure, engagement and meaning in their lives while minimizing     depression, fear, loneliness and other negative feelings via a proprietary peer based program     that offers weekly meetings and other flexible support options. The goal of this pilot study     is to test the efficacy of this program. This is not traditional therapy, rather an     educational supportive program similar to WeightWatchers, but for mental health.   "
55585|NCT02558062|"     Critically ill patients are often ventilated in dedicated critical care units to provide     respiratory support. Despite best practice patients can often develop a condition called     adult respiratory distress syndrome (ARDS), which is characterised by deterioration in their     respiratory function, and changes on chest x-ray. The correct management for ARDS is     identifying the underlying condition causing the deterioration and identifying appropriate     targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs     of a ventilated patient. The patients may have been ventilated due to pneumonia but they may     also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has     significant mortality.      Despite all the clinical and laboratory data at the investigators' disposal there remains     great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often     given empirically. Therefore, there is an urgent clinical need for accurate methods to     diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As     such, the investigating team have developed and synthesised an imaging agent called BAC ONE.     BAC ONE will be instilled directly into the lungs of 12 patients (with and without lung     infection) to assess whether it can label bacteria in the human lung.   "
55586|NCT02558049|"     BACKGROUND: Proton pump inhibitors (PPIs) treat problems such as gastroesophageal reflux     disease (GERD). In many patients with mild or moderate GERD, PPIs should be used for 1-2     months but are often continued longer unnecessarily. This is a problem because PPIs may cause     harm when used long-term. PPI use is associated with severe C. difficile infections,     fractures and pneumonia. Canada's public drug programs spent $247 million on PPIs in 2012     (not including Quebec or PEI). Due to concerns with long-term PPI use, patients may face the     decision to continue their PPI, use a lower dose or stop and use on-demand (only when     symptoms return). This decision should be made collaboratively between patients and     clinicians, though patients tend to have a poor understanding of when reducing a drug is     appropriate. Using a lower dose or using on-demand may be viewed as difficult because of the     chance of symptoms returning. Patient decision aids (PDAs) inform patients on benefits and     risks of treatment options and improve ability to make informed decisions and clarify values.     OBJECTIVES: Develop a PDA to help patients with the decision to continue PPI or stop and use     on-demand/use a lower dose. Evaluate whether: 1) the PDA changes patient preference to     continue or stop and use on-demand/use a lower dose of PPI 2) the PDA improves patient     knowledge and realistic expectations 3) patients and pharmacists feel they made a shared     decision 4) there is a change in PPI prescribing 8 weeks post-PDA and 5) patients' choices     match up with their values. METHODOLOGY: The PDA will be developed by a team of doctors,     pharmacists and patients. It will be delivered during a visit with a pharmacist. Patients     (n=54) will indicate which choice they prefer (continue PPI/stop or use lower dose) before     and after going through the PDA. We will use Mcnemar's test to compare the number of patients     preferring to continue their PPI before and after. We will evaluate whether there is a     difference in knowledge test scores and expectations test scores before and after the PDA.     After the PDA, we will ask patients and pharmacists to rate the extent to which shared     decision making occurred and measure the agreement. Values/choice congruence will be     evaluated using logistic regression. Eight weeks after patients have received the PDA, we     will look at whether there is any reduction in PPI use.   "
55587|NCT02558036|"     Optimal patient head and neck position when performing videolaryngoscopy for endotracheal     intubation has not yet been established.The investigators aim to assess the effect of two     different positions on the laryngeal view obtained and success of tracheal intubation during     videolaryngoscopy with two commercially available and well established videolaryngoscopes.   "
55655|NCT02557152|"     The purpose of this registry is to gain a real world perspective for the use and outcomes     associated with the Sonendo® GentleWave System usage. The registry population includes up to     500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical     sites in the United States.   "
55588|NCT02558023|"     The objective of this study is to demonstrate that urapidil is not inferior to nicardipine     for the treatment of hypertension associated with preeclampsia (PE) and that it is better     tolerated.        -  efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min          of study drug administration.        -  safety endpoints : clinical and biological observation for any side effect. All infants          will be observed in the neonatology unit (during 48h).      Pharmacokinetic study included to study :        -  transplacental transfer,        -  transfer in breast milk,        -  and neonatal elimination (premature babies of mothers treated with urapidil (less than          33 WG))   "
55589|NCT02558010|"     Acute pain management following major surgical procedures in pediatric patients continues to     be a challenge, especially after extensive posterior spine fusions.      Spine surgery is particularly traumatic, initiating pain in both peripheral and central     pathways. While the standard management of post-surgical pain involves a multimodal approach,     opioids provide the predominant benefit. However, opioid use is associated with many adverse     effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease     total opioid consumption and adverse effects as well as improve satisfaction with pain     management after scoliosis repair.   "
55590|NCT02557997|"     We aim at comparing markers of HIV reservoir, monocyte function and immune activation between     antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled     or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The     investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble     CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6     (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points     between baseline and week 48 post DTG-based regimen initiation in each group.   "
55591|NCT02557984|"     The purpose of this study is to determine how the dopamine and opioid system is involved in     reward processing, specifically in cue-induced reward responding and reward impulsivity,     using dopamine and opioid receptor antagonists in healthy participants. The investigators     predict that particularly the dopamine challenge should alter cue-induced reward responding     and reward impulsivity. Such effects would be of high interest for the treatment of disorders     which involve impairments of reward processing such as addiction.   "
55597|NCT02557906|"     Some women with breast cancer have their whole breast removed as part of their treatment     (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are     two main ways to create a new breast(i)using tissue from elsewhere on the body (autologous     reconstruction )or (ii)using a silicone implant.      In recent years, it has been reported that by using a material called an acellular dermal     matrix (ADM) the results of breast reconstruction surgery using an implant can be improved.     ADMs are materials which originally come from animal or human skin. They act like a sling,     supporting the lower part of an implant beneath the skin.      Although ADMs have been approved for used in breast reconstruction and are safe, there is     very little high quality evidence to back up their reported benefits, and some studies have     suggested their use may in fact increase complications.      The main purpose of this study is to find out what the actual risks and benefits of using an     ADM in breast reconstruction surgery are. The investigators will follow the progress of women     who have an implant based reconstruction to observe if participants develop problems; what     those problems are and how participants feel about the results of their surgery. The     investigators also follow the progress of women who undergo autologous reconstruction or     alternative reconstructive techniques using an implant for the same reasons.   "
55598|NCT02557893|"     Pregnant women at increased risk for back pain were studied during the second trimester and     randomized to12-weeks of resistance exercise, education or waitlist. Several outcomes were     assessed including physical function, quality of life and mood.   "
55599|NCT02557880|"     The purpose of this study will be to see if adolescents can advance bedtime above what can be     accomplished by counseling alone simply by inputting their information into a sleep     application diary and reporting this information back to their sleep doctor.   "
55600|NCT02557867|"     The purpose of this study is to study the effect of obesity in dexmedetomidine     pharmacokinetics and pharmacodynamic profile.   "
55601|NCT02557854|"     The purpose of this study is to determine whether Doxil (liposomal doxorubicin) given prior     to MR-HIFU Hyperthermia is safe for the treatment of pediatric and young adult patients with     recurrent and refractory solid tumors.   "
55602|NCT02557841|"     A crossover trial with healthy volunteers will be conducted. Three sessions will be performed     with at least 48 hours washout period to minimize carry-over effects. In each session,     volunteers will be submitted to: fatigue and attention levels evaluation, handwriting test,     serial reaction time task (SRTT) before and after ctDCS conditions and after session, a     performance perception evaluation.   "
55656|NCT02557139|"     Bioavailability, Phase I study to evaluate the clinical performance of the tablet formulation     in the fasted and fed states, in comparison to the capsule formulation in the fed state.   "
55603|NCT02557828|"     Invasive blood pressure monitoring is achieved by cannulating an artery and transducing the     pressure. During arterial cannulation the artery can be located by palpation, but use of     ultrasound has increased the success rate of cannulation. A new ultrasound technique for     vascular cannulation (dynamic needle tip positioning) has been described. Investigators aim     to compare this technique to the palpation technique for arterial cannulation. Investigators     hypothesize that the use of this novel ultrasound technique will result in a higher first     attempt success rate and overall success compared to palpation.      Investigators plan to enroll 310 patients in this study. The participants in the study will     have been deemed by the attending anesthesiologist to require a radial arterial line for the     operation and thus the research protocol will not involve a deviation from the standard of     care.   "
55604|NCT02557815|"     This current project investigates the effect of a single session of right dlPFC repetitive     transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol     dependent patients and healthy controls.   "
55605|NCT02557802|"     The investigators will explore in an experimental medicine healthy human model of     immunisation, whether switching the route of sequential administration of licensed influenza     vaccines can result in an immune response that is broader in its ability to recognise     different substrains of influenza viruses. The investigators will do this by initially giving     an immunisation with a nasal or an injected vaccine, and then switching subjects over to     receive a second dose one month later (when the cellular component of immunity will have     matured) via the opposite route (nasal->injected or injected->nasal). The investigators will     use research assays that can map the different parts of the influenza virus that the     vaccinated person's immune cells recognise at baseline, after the first immunisation, and     then again after the second, to see if the breadth of the recognition has broadened to     include new strains or virus components. Should this pilot study give an indication that the     breadth has widened (rather than just a further boost to the same responses seen after the     first immunisation) it will provide justification for a larger study in which statistical     significance may be powered for observed changes.      The study is funded by ADITEC, which is a collaborative research programme that aims to     accelerate the development of novel and powerful immunisation technologies for the next     generation of human vaccines.   "
55606|NCT02557789|"     A Phase 1 study to assess the bioavailability and pharmacokinetics of a 600 mg immediate     release tablet formulation of lefamulin when administered to fed and fasted healthy subjects     in comparison to an intravenous formulation and a capsule formulation.   "
55607|NCT02557776|"     The overall purpose of the study is to evaluate a method for offering mutation analysis of     BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at     diagnosis and family history. Information about the study as well as pre-test genetic     counseling will primarily be given in a written way. In addition to that, if a study     participant wishes to, she can also receive pre-test telephone genetic counseling.   "
55608|NCT02557763|"     The aims of this study is to compare the results between patients without severe     patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile     bearing UKA.      The investigators prospective compute the results including anterior knee pain, knee society     score, pain score, functional score, range of motion, operative time, blood loss, and     component alignment.   "
55609|NCT02557750|"     The aim of this study is to retrospectively investigate the effect of combined modality     treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance     with the experience at the pediatric oncology department at South Egypt Cancer Institute.   "
55613|NCT02557698|"     Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized     by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be     compromised. Skin care practices to decrease the risk of development of dry skin and/or to     improve dry skin condition have barely been investigated. Bathing with bath oils has been     shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore,     the aim of this study is to investigate the effect of bathing every other day on the skin     barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH     (pH) were measured to characterize skin barrier function.   "
55614|NCT02557685|"     This study aims to document early changes in the distal gut microbiota (both fecal and     mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate     collaborative immunologic and metabolomic analyses.      This will be an open label clinical trial of FMT to prevent further recurrence in patients     who have suffered at least a third episode of Clostridium difficile infection (CDI) and who     have previously been treated with oral vancomycin.   "
55615|NCT02557672|"     This will be the first prospective randomized controlled clinical trial directly comparing     Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post     cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a     difference in bleeding and transfusion requirements in patients received PCC versus FFP?   "
55616|NCT02557659|"     This extended investigation is to provide continued physician access to the device and     collect confirmatory safety and effectiveness data.   "
55617|NCT02557646|"     The purpose of this open-label, non-randomized, single-arm, multicentre observational study     is to investigate the influence of the cumulative dose (total administered dose/ planned     dose) of ribavirin on the sustained virologic response (SVR) in participants who have been     receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin     (Copegus).   "
57473|NCT02533284|"     Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic     cholecystectomy.   "
55618|NCT02557633|"     There is increasing evidence that the effectiveness of allergy immunotherapy to control     symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid     administered during a single regimen of subcutaneous (SC) injections or of sublingual     administration.      Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are     being developed to compare with the current dose of 5100 SU. The purpose of this study is to     evaluate the tolerability and safety of these two new cumulative dose regimens of Grass MATA     MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to     grass pollen, to enable selection of the best dose to go into a larger scale study to assess     the efficacy and safety of the higher cumulative doses.   "
55619|NCT02557620|"     This trial is conducted in Europe. The aim of this trial is to compare the steady-state     exposure of semaglutide administered subcutaneously once daily to semaglutide administered     subcutaneously once weekly in healthy subjects.   "
55620|NCT02557607|"     A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating,     repeatable over time, appears promising in the field. This sequence allows for routine,     generate perfusion maps relating to the entire brain volume   "
55621|NCT02557594|"     This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg     and Viread 300mg after a single oral dose in healthy male volunteers.   "
55622|NCT02557581|"     The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been     well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the     present study is thus to investigate the role of cAMP signaling by beta2-adrenergic     stimulation for muscle adaptations in humans.   "
55623|NCT02557568|"     The nasal carriage of Staphylococcus aureus is a major risk factor of S. aureus infection,     notably in hemodialysis patients (HPs). Decolonization strategies were shown able to reduce     the rate of S. aureus infection in this category of patients although the risk of emergence     of antimicrobial resistance persists. Approximately one quarter of the general population is     colonized by S. aureus in the anterior part of the nostril (vestibulum nasi). Three main     categories of nasal carriers have been historically identified: persistent carriers (20%,     12-30%]), intermittent carriers (30%, [16-70%]) and non-carriers (50% [16-69%]). By contrast     to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of S.     aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery.      Persistent carriers are characterized by a higher nasal bacterial load, a longer duration of     carriage, a lower rate of exchange of S. aureus strains, and a particular affinity for the     carried strain. However, there is no consensual definition of this persistent carriage state.     In previous studies, 5 to 12 nasal sampling episodes were realized for a period ranging from     5 weeks to 8 years. The index of carriage, corresponding to the number of samples positive     for S. aureus divided by the total number of samples, has been proposed to standardize the     definition of the carriage state. According to standard tools, it is almost impossible to     determine the nasal carriage state in routine practice.      Recently, an algorithm based on one or two quantitative cultures from nasal samples taken     within 2 days that was able to distinguish accurately persistent and non-persistent nasal     carriers of S. aureus has been described; only one nasal sample was needed in more than 9     cases out of 10. The aim of the present study was to assess prospectively the reliability of     this algorithm in clinical practice in a cohort of healthcare workers (HCWs) and HPs and to     check its ability for identifying patients with the highest risk of S. aureus infection   "
55624|NCT02557555|"     The purpose of this study is to learn how the investigators can better educate pregnant     patients about the options open to them for pain relief during labor. Patients will receive     educational pamphlet during prenatal clinic visit and again on admission to labor and     delivery. The options for analgesia will be discussed by anesthesia care provider. Patient     will be asked to complete a survey on the post partum unit.   "
55625|NCT02557542|"     A pilot randomised controlled trial looking at the setting up of a one stop vein clinic for     the treatment of varicose veins and assessing the quality-adjusted life years at 3 months of     patients This will be a pilot study which is designed to provide us with enough information     for a potentially larger multicentre randomised controlled study.   "
55664|NCT02557035|"     PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron     0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered     as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The     objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective     as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced     by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single     cycle of highly emetogenic chemotherapy   "
66037|NCT02421315|"     The purpose of this study is to examine the brain functioning of children and adolescent with     OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.   "
55626|NCT02557529|"     72 patients with head and neck cancer, undergoing primary treatment with radiation therapy     and concomitant weekly cisplatin, will be recruited to this multicentre trial.      Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control     arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre,     gender, p16-status and body mass index (BMI) below or above 30.      Primary endpoint is difference in change in lean body mass (LBM) between the groups and the     endpoint is reduction of LBM loss in intervention arm by 25% compared to control.      Secondary endpoints include side-effects to treatment, change in body composition, physical     function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise     and work affiliation will also be registered.      Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for     proteomics analyses and histological analyses.   "
55627|NCT02557516|"     Combination study of IPH2201 with Ibrutinib in relapsed or refractory Chronic Lymphocytic     Leukemia (CLL) patients in 2 parts :        -  phase 1b : a 3+3 design to assess the Maximum Tolerated Dose (MTD)        -  phase 2a: to evaluate the anti-leukemic activity of the combination   "
55628|NCT02557503|"     To investigate the therapy effect and security of oxaliplatin and fluorouracil on with or     without concomitant vascular invasion and extrahepatic metastases unresectable advanced     primary liver cancer   "
55629|NCT02557490|"     The purpose of this study was a randomized controlled trial to compare the effect of     oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE     hepatic artery infusion   "
55630|NCT02557477|"     The primary objective was to assess whether supplementation of Omega 3/6 fatty acids improves     mainstream schoolchildren's reading ability. The secondary objective was to assess whether     Omega 3/6 improves cognitive functions such as attention, memory, learning,     language/communication, problem solving and social ability.This was a 3-month randomised,     double-blind, placebo-controlled study followed by one-way crossover (placebo to active     treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were     initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo.     All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome     measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities.     Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder     (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and     problem solving); Social and Communication Disorders Checklist (to evaluate social ability)   "
55657|NCT02557126|"     The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate     Lowering Effect of URC102 in gout patients.   "
55632|NCT02557451|"     AMD is a disease of the central retina, a zone that enables fine detail activities (reading,     detail…). This central zone of the retina can be affected by a haemorrhagic complication when     small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic     approaches are currently available even though they have never been truly compared. The study     will be proposed to patients who need to be treated for haemorrhage of the macula. A certain     number of factors will be evaluated to compare the 2 principal approaches currently used in     France: surgery followed by injections of an anti-angiogenic OR intravitreal injections of     gas followed by injections of anti-angiogenics. This is a multicentre, randomized controlled     trial to compare these 2 therapeutic approaches.      These diametrically opposed approaches have very different consequences for patients and in     terms of cost for society. The consequences for patients will be immediately measurable so as     to determine the best therapeutic approach in terms of functional recovery and the impact of     the disease on quality of life, while taking into account the risks inherent to these 2     treatments. The impact on quality of life of these 2 approaches as well as their consequences     - an important factor in this disease, which is a cause of sensory handicap - will provide     the ophthalmological community with essential information making it possible to validate one     or the other of these methods for the management of these haematomas.   "
55633|NCT02557438|"     The purpose of this study is to examine the impact of weight-loss surgery (Roux-en-Y gastric     bypass or Vertical Sleeve Gastrectomy) on bone outcomes in girls and boys ages 14-21. This     study will also examine a group of overweight boys and girls who are not scheduled or planned     for surgery for comparison of these outcomes.      Obese adults who undergo weight-loss surgery are at risk for bone loss and decreased bone     strength. The investigators do not know the effects of such surgery on bone in teenagers and     young adults. The purpose of this study is to find out how different types of weight loss     surgery affect bone density and strength in teenagers and young adults and compare these     results to obese teenagers and young adults who are not undergoing weight-loss surgery.   "
55634|NCT02557425|"     Each year, ~85.3 million pregnant women are at risk of becoming infected with Plasmodium     falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical     immunity to malaria, malaria infection in pregnancy leads to placental malaria (PM), often     without clinical symptoms in the mother. The systemic and placental changes that occur with     malaria in pregnancy can adversely affect the developing fetal brain, an fetal brain injury     strongly affects long-term childhood neurodevelopmental (ND) and behavior but there are no     published studies to date on the impact of malaria in pregnancy on childhood ND. This study,     conducted in Uganda, will address the effects of malaria in pregnancy and childhood ND and     define mechanisms by which malaria may lead to ND impairment including micronutrient     deficiencies. ND outcomes will be measured by the following neuropsychological and behavioral     tests: Mullen Scales of Early Learning, the Color Object Association Test, the Early     Childhood Vigilance Test, the Behavior Rating Scales, the Behavior Related inventory of     Executive Function and the Child Behavior Checklist. These tests will be given at 12, 24 and     36 months of age. This study will be nested in an ongoing Ugandan IRB approved interventional     trial (PROMOTE-II) (NCT02163447). Blood sampling is being conducted in the PROMOTE-II     protocol for research purposes. Some of that blood will be used to test for micronutrient     deficiencies as well as other immune responses to malaria.   "
55803|NCT02555202|"     The main objective of this study is to develop and to validate a French version of the London     Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of     this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD     patients (stages severe and very severe).   "
55635|NCT02557412|"     OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with     conventional treatment, improves the lipid profile of patients with dyslipidemia and     mild-moderate apnea-hypopnea syndrome (OSA).      Secondary objectives:        -  Determine the additional effect of CPAP on insulin resistance and dyslipidemia in          patients with mild-moderate OSA.        -  Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with          dyslipidemia and mild-moderate OSA.      DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional     treatment.      STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and     in stable treatment during the last month with diet, cholesterol lowering drug, and     cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.      Sample size. 38 patients who completed the test in each treatment arm.      TREATMENT      Patients will be randomized to one of the following treatment arms form:        1. hygiene and dietary recommendations.        2. lifestyle intervention (more strict and promotion of daily physical activity and dietary          control).        3. Treatment with positive airway pressure (CPAP).      ENDPOINTS:      Efficacy endpoints.        -  Primary endpoint: LDL-cholesterol.        -  Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high          sensitivity (hsCRP).        -  Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α),          oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion          molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic          activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A /          hypocretin-1 and ghrelin).        -  Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model          Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI),          thyroid-stimulating hormone (TSH).        -  Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep          Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ).      Security endpoints.        -  Notification of clinical adverse events.        -  Compliance with CPAP (average hours use per day).        -  Epworth Sleepiness Questionnaire.        -  Development of cardiovascular events.   "
55636|NCT02557399|"     This is a multicentre, randomized, single-blind (investigator is blinded), active (the     combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group     study in Japanese subjects with facial acne vulgaris. The purpose of this study is to     evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3%     (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus     combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne     vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will     use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including     the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination     therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the     forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice     daily, once in the morning and once in the evening (at bedtime) for 12 weeks.   "
55637|NCT02557386|"     To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in     unilateral cruciate ligament of the knee reconstruction surgery.   "
55638|NCT02557373|"     The purpose of this study is to assess feasibility of rice bran consumption in weaning     children and to identify dietary rice bran mediated changes to the stool microbiome and stool     metabolome.   "
55671|NCT02556944|"     To assess postsurgical visual acuity (distant, intermediate, near), refractive errors,     contrast sensitivity, visual function and patient satisfaction after implantation of     multifocal IOLs of different add power contralaterally.   "
55639|NCT02557360|"     Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to     several symptoms such as intractable pruritus or chronic fatigue, significantly impairing     patients quality of life. Recent studies show, that chronic liver diseases are associated     with an acquired deficiency of S-adenosyl-L-methionine (SAMe) synthetase, responsible for the     synthesis of SAMe from methionine. SAMe deficiency is associated with impaired detoxification     and hepatoprotection and exacerbate liver injury. Supplementation with SAMe has proven useful     in several liver diseases.      The study group will include 20 patients with PBC diagnosed with European Association for the     Study of the Liver (EASL) criteria, who have been already treated with ursodeoxycholic acid     (UDCA). They will receive SAMe in the dose of 1600 mg bd over the period of 6 months. Both     clinical and laboratory aspects will be analyzed: liver serum biochemistry, serum and urine     bile acids metabolites, transient elastography and health related quality of life.   "
55640|NCT02557347|"     The objective of this study is to determine the effectiveness of treating peritoneal dialysis     (PD) patients with fluid overload by a structured nurse-lead intervention protocol. We plan     to recruit 100 PD patients with fluid overload. These patients will be assessed and managed     by a renal nurse specialist in the ambulatory renal center according to a standardized     protocol. The improvement in the degree of overhydration will be determined by bioimpedance     spectroscopy 4 and 12 weeks after treatment.   "
55641|NCT02557334|"     The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL     cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other     lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive     compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol,     as well as blood pressure and arterial health.   "
55642|NCT02557321|"     This is an international multicenter, open-label, sequential phase study of intralesional     (IL) PV-10 in combination with immune checkpoint inhibition. Stage IV metastatic melanoma     patients with at least one injectable cutaneous or subcutaneous lesion who are candidates for     pembrolizumab will be eligible for study participation. In the Phase 1b portion of the study,     all participants will receive the combination of IL PV-10 and pembrolizumab (i.e., PV-10 +     standard of care). In the subsequent Phase 2 portion of the study participants will be     randomized 1:1 to receive either the combination of IL PV-10 and pembrolizumab or     pembrolizumab alone (i.e., PV-10 + standard of care vs. standard of care).   "
55643|NCT02557308|"     An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in     Patients with Ankylosing Spondylitis   "
55644|NCT02557295|"     An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in     Patients with Rheumatoid Arthritis.   "
55645|NCT02557282|"     The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed     Tomography (CT) Perfusion (investigational device) imaging performance. Evaluation of CT     Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS with     CT Perfusion Module.   "
55805|NCT02555176|"     This pilot clinical trial studies the effects of a low carbohydrate diet on tumor metabolism     in patients with head and neck cancer. A low carbohydrate diet may reduce the metabolic     activity of cancer cells and of surrounding supportive tissues. Studying samples of tissue     and blood from patients with head and neck cancer in the laboratory before and after a low     carbohydrate diet may help determine any changes in tumor metabolism.   "
55646|NCT02557269|"     ASIT naïve patients sensitized to grass pollens will be recruited for the study. All of them     will be instructed to treat bothersome in-season symptoms when they appear (on as needed, pro     re nata basis) with rescue medication. They will be given 5 different options and will be     informed about the effects of each of them in order to make their optimal choice for     different symptoms and their combination: local decongestant (xylomethazoline, when     congestion is leading), local antihistamine (azelastine, when itching, sneezing and rhinorhea     a predominant), nasal corticosteroid (momethasone, when all nasal symptoms are pressing and     no adequate relief is obtained form the other 2 local treatments), oral antihistamine     (bilastine, when itching and sneezing persist despite the local treatments) and oral     corticosteroid (prednisolone, when any or all symptoms become unbearable despite the other     suggested treatments). Patients who are reluctant to use immunotherapy or who are too late to     initiate it will be randomized to be treated with the listed medications on as needed basis,     the nasally applied formulations will be followed by either HPMC to prolong and enhance their     effect (Group HPMC) or placebo (lactose powder) (Group Placebo) to serve as control. Patients     indicated and willing to carry out ASIT will be treated according to the standard protocol     with grass allergens sublingually (Staloral #688) and will receive rescue medication (Group     Immunotherapy).   "
55647|NCT02557256|"     The aim of the study is to retrospectively review data about malignancies that arise     primarily in the pelvis and/or in the pelvic organs, in pediatric cancer patients &     categorize the spectrum of these malignancies according to experience at South Egypt Cancer     Institute which is the largest referral site in Upper Egypt.   "
55648|NCT02557243|"     The aim of this study is to identify demographic & disease characteristics in pediatric     oncology patients diagnosed with soft tissue & bone tumors involving the extremities &     treatment outcomes in these patients.   "
55649|NCT02557230|"     The aim of this study is to identify demographic & disease characteristics in pediatric     oncology patients diagnosed with one of genitourinary tumors & treatment outcomes in these     patients.   "
55650|NCT02557217|"     NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a     treatment for people after they have had a heart attack (MI).   "
55651|NCT02557204|"     The primary aim of this study is to investigate the difference in the first attempt and     overall success rate of different techniques for insertion of nasogastric tube. Secondary aim     is to investigate the difference of the duration of insertion using the selected technique,     complications during insertion such as kinking, knotting, mucosal bleeding   "
55652|NCT02557191|"     Approximately 2% of neonates in the US are born very preterm. Preterm births are associated     with impaired cognitive, language and motor function, and increased risk for autism spectrum     disorders. Epidemiological studies indicate a dose-response relationship between gestational     age at delivery and cognitive impairments, with the most immature of newborns being the most     susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term     neurocognitive impairments are currently lacking. The investigators seek to identify     epigenetic markers that mediate the relationship between adverse prematurity-related     exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that     DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm     infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment     in childhood.   "
55658|NCT02557113|"     Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral     body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate     of cement leakage is of value and makes the procedure safer.The aim of this study was to     investigate the effect of the creation of a cavity on cement leakage during vertebroplasty.     Investigators tested the hypothesis that the creation of a merely small and irregular cavity     in vertebral body prior to cement injection would reduce cement leakage.   "
55660|NCT02557087|"     The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine     for analgesia during the first stage of labor.   "
55661|NCT02557074|"     In a prospective pilot study the investigators showed that low doses of IL2 could be     beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.      The objective of this study is to compare the long term efficacy of low doses of IL2 versus     placebo in a multicenter prospective randomized double blind study.   "
55662|NCT02557061|"     Colorectal cancer (CRC) is one of the most common cancers in France (36,000 new cases / year)     and nearly 16,000 people die each year from this disease. The lymph node involvement of the     surgical specimen is today the main tool on which is based the adjuvant treatment decision     after curative surgical resection. The study of new predictive factors to identify patients     at risk for developing a local or metastatic recurrence is therefore a major challenge.      It is now clear that the immune system plays a role in the control of tumor's development,     and it was shown that there was a correlation between the presence of a CD3+ T-lymphocyte     infiltrate in colorectal cancers and patient survival. Preliminary studies suggest an     important role of regulatory T-lymphocyte in the modulation of the antitumor immune response.     The aim of our study is to follow a cohort of patients operated for colon cancer with     curative intent to highlight the prognostic characteristics of the tumoral infiltrate by     various lymphocyte populations (particularly T-lymphocytes but also B-lymphocytes and     regulatory lymphocytes). It will be performed a preoperative analysis of blood circulating     lymphocytes with antibodies specific for different cell populations (CD3, CD4, CD8, CD56,     CD16, CD19, CD2) and stage of activation (CD25, CD69, HLA-DR ) or differentiation (CD24,     CD38, CD27, CD103, CD62L, CCR7, CD45RA / RO, IgD). The presence of regulatory T-lymphocytes     will also be analyzed. It will be performed on tumor sample a Tissue Microarrays for     immunohistochemical study to determine the presence of different lymphocyte populations. We     systematically study the markers CD68 (monocytes / macrophages), CD56 (NK cells), CD20 and     CD79a (B cells / plasma cells), CD3 (T cells), CD8 (cytotoxic T), CD4 (helper T) FoxP3     (regulatory T), cytotoxicity of CD8 markers (Fas ligand, perforin and granzyme) and MHC I     (antigen presentation) to explore the innate and adaptive immune responses. For each section,     the different zones will be analyzed (center and invasive margin and healthy tissue). The     main objective of the study is the influence of the tumor infiltration rate by CD3 + T cells     on disease free survival at 2-years in patients with non-metastatic colon cancer resection.     The secondary objective is to search a correlation between the rate of T-lymphocytes on     preoperative blood sample and on tumor sample.   "
55663|NCT02557048|"     The aim of the study is to identify demographic characteristics, various histopathologies,     and site preferences for each disease entity of malignant head and neck tumors in pediatric     oncology patients & treatment outcomes in these patients, according to experience at South     Egypt Cancer Institute which is the largest referral site in Upper Egypt.   "
55977|NCT02552914|"     Study objectives:        -  To evaluate the usability of the Colli-PeeTM device to collect first-void urine for          nucleic acid detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas          vaginalis and Mycoplasma genitalium.        -  To collect feedback on the easiness of use and the willingness of future use of the          Colli-PeeTM device.   "
55665|NCT02557022|"     A low glycemic index (GI) diet has been associated with improved glycemic control in type 2     diabetes patients and a reduced risk of cardiovascular disease (CVD). Low glycemic load (GL)     diets have been associated in cohort studies with a reduction in both diabetes incidence and     CVD events, especially in overweight individuals, and have been recommended by the Canadian,     American and European diabetes associations. Life style modification trials have shown that     reducing body weight in overweight or obese individuals improves obesity-related risk     factors. The process of a systematic review combines the results from many studies in order     to arrive at a pooled weighted average of the true effect. The investigators propose to     conduct a systematic review and meta-analysis of the highest quality evidence from randomized     controlled trials to assess the effect of low GI/GL diets on body weight change. The results     of this synthesis will inform clinical practice guidelines and lead to better health outcomes     through informing healthcare providers and patients, stimulating industry innovation, and     guiding future research.   "
55666|NCT02557009|"     The study is designed as a prospective observational study. Each participant will have their     BP, CVP, PAP, and CO measured by their clinical nurse using indwelling catheters placed for     routine patient monitoring. Measurements will be recorded on an hourly basis during the day     and for as many days as possible if the required measurements are being made for clinical     care.      Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of     convenience sampling. Data will be analyzed using a test of equivalence on the initial     measurements (test of equivalence between two means) and then over time (repeated     measurements) with a linear mixed-effects model.   "
55667|NCT02556996|"     This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian     children 6-18 months of age. The primary aim of the study is to determine the protective     efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine     against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over     a one year period of follow-up by active surveillance. The vaccine consists of a mixture of     five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and     recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation is     heat-killed Escherichia coli K-12 bacteria.   "
55668|NCT02556983|"     The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute     appendicitis, by using of dose simulation technique and iterative reconstruction.   "
55669|NCT02556970|"     This study seeks to establish if thoracoscopic surgery performed through a single port or     incision reduces early post-operative pain compared with conventional multiple port     thoracoscopic surgery.      This initial pilot study is designed to establish whether a trial of the two techniques is     acceptable to patients, clinically feasible and can be delivered in a reasonable timescale.   "
55670|NCT02556957|"     Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV hotspot     with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service     utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations,     compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have     recognized the urgent need to target hotspots with enhanced HIV treatment and prevention     efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies     for hotspots is limited and is thus a priority need for the field.      The investigators propose an implementation science, cluster-randomized, controlled trial in     Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting     combination HIV prevention (CHP) services supported by mobile health technologies (mHealth).     CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing     and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to     maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV     incidence, most community members must be assessed for risk factors and current CHP     utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The     proposed intervention will use low-cost CHWs leveraging mHealth decision support and     counseling tools to promote CHP along this entire continuum of HIV service utilization. The     hypotheses for this implementation science research are that residents in clusters receiving     the implementation intervention will have improved CHP service uptake and decreased     Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.      The intervention will be evaluated through a pragmatic, cluster-randomized trial nested     within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort     Study (RCCS). Intervention arm participants will be visited in their place of residence by     CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP     health counseling, linkage, and adherence support, all supported by a mHealth decision     support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will     be HIV incidence, population viral load, implementation measures, retention, virologic     suppression, and sexual behaviors.      Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial     will be conducted to evaluate implementation processes, facilitators, and barriers to inform     study results and future program uptake. Focus groups and in-depth interviews will be     conducted during and after the follow-up period and synthesized with quantitative data.     Intervention costs will be prospectively measured to provide information on program     affordability.      Through this study, a novel, low-cost, and scalable implementation intervention to improve     CHP uptake will be evaluated in an HIV hotspot critical to controlling the HIV epidemic.     The study design ensures rigorous evidence of immediate relevance to many stakeholders.   "
55674|NCT02556905|"     The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the     safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to     the approved package insert, after approval of marketing authorization for new drug in Korea.     In addition, the efficacy information of REVLIMID® in clinical practice is collected and     evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing     surveillance.      The patients can be recruited through both Drug Use Examination after the initiation of Post     Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was     performed before REVLIMID® reimbursement.      Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for     safety assessment has been conducted by site monitoring process by 07Dec2016.      REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug     Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs),     unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety &     efficacy of the drug.      It is necessary to examine patients' demographics and baseline characteristics, medical     history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and     final efficacy (best response) assessment.   "
55675|NCT02556892|"     The purpose of this study is to evaluate the safety of Ibrutinib in Japanese participants     with treatment-naive chronic lymphocytic leukemia ( CLL) or small lymphocytic lymphoma (SLL).   "
55676|NCT02556879|"     Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor specific     antibodies (DSA) is an underestimated factor in liver transplantation and may contribute to     dysfunction and graft loss , especially among candidates for retransplantation, that have     major immunization.      This study will analyzed immunization markers at the time of liver retransplantation and     systematically in patients follow-up. This will allow to characterize the histological     lesions due to humoral immunization, to establish further investigations and to adapt early     immunosuppressive therapy.   "
55677|NCT02556866|"     Multicenter randomized double-blind study comparing the efficacy and safety of rituximab in     combination with corticosteroids to corticosteroids plus placebo in the treatment of     non-infectious active mixed cryoglobulinemia vasculitis.   "
55678|NCT02556853|"     The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The     correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®)     for the patients of the one group (group U) and by clinical examination for the patients of     the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®).     The two methods will be compared in terms of sensitivity and specificity. The main purpose of     the study is to determine if the ultrasound can be used for determination of the correct     placement of the left sided double lumen endotracheal tube   "
55704|NCT02556515|"     Interpositional arthroplasty is by many considered to be the current gold standard for the     treatment of thumb carpometacarpal arthritis. The results are generally good, but the     rehabilitation time can be long and failures are difficult to treat. Total joint replacements     now exist with modern uncemented designs that can be an alternative treatment. Short term     studies show that thumb function often is better and rehabilitation time shorter, however     there is uncertainty with regards to the longevity of the implants. Currently no prospective     randomized trials have compared these two treatment options. Our hypothesis is that the total     joint replacement will give the same results or better when compared to the interpositional     arthroplasty.   "
55679|NCT02556840|"     Maturity-onset diabetes of youth (MODY) are the most frequent monogenic diabetes with     autosomic dominant inheritance (2% of diabetes). The MODY2 diabetes is related to a defect in     the glucokinase (GCK) enzyme, the first limiting step of insulin secretion. An abnormal GCK     leads to a delayed insulin secretion. Patients with GCK mutations have only mild raised     fasting plasma glucose. Treatment is usually unnecessary since hyperglycemia is stable and     MODY2 patients have no microvascular complications of diabetes. In contrast, pregnancy in     MODY2 women is a challenging situation. A non-mutated fetus will produce excess insulin in     response to raised maternal blood glucose leading to an accelerated growth and a higher risk     of macrosomia. The mother of non-mutated fetus should therefore be treated to normalize her     blood glucose levels. On contrary, a mutated fetus will produce a delayed insulin secretion     (as his MODY2 mother) in response to maternal hyperglycemia. Consequently insulin therapy     during pregnancy would reduce fetal insulin secretion and result in a low birth weight.      Moreover, insulin therapy exposes pregnant women to more labor induction, prematurity and     cesarean deliveries. In these MODY2 women whose glucose set point is physiologically higher,     glycemic goals are difficult to achieve while often requiring extensive insulin therapy. An     optimal situation would consist in initiating insulin therapy only for women with non-mutated     offsprings. Unfortunately no antenatal diagnosis of the GCK mutation on fetal cells is     available yet. In literature, birth weight differences between mutated and non-mutated     neonates may reach up to 700g. In clinical practice, two strategies are used but without     standardized protocol on glycemic targets, delay and doses of insulin : 1) insulin at     diagnosis of pregnancy 2) treatment based on fetal abdominal circumference and fetal weight     measurements by ultrasonography (US) and initiated if fetal biometry is greater than the 75th     percentile.      The purpose of the study is to evaluate for the first time these two management strategies     through a prospective and standardized study. Hypothesis: US assessment would be sufficient     to identify fetuses at risk of macrosomia and to initiate insulin treatment in mothers.   "
55680|NCT02556827|"     Aim of study is to determine reactive oxygen products and antioxidant capacity with rosacea     patients; to measure metalloproteinase level and inflammatory markers of immune response and     investigate their corelation with demodex infestation and also investigate the role of     photoaging and sebum secretion in rosacea.   "
55681|NCT02556814|"     The project was undertaking by Qilu Hospital of Shandong University in China. In order to     report the efficacy and safety of caffeic acid tablets combining with high-dose dexamethasone     for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).   "
55682|NCT02556801|"     The purpose of this study is to assess safety, tolerability and demonstrate a dose response     signal using Total Symptom Score (TSS), based on challenges with grass pollen in an     Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of     SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.      The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.   "
55684|NCT02556775|"     The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20     antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA.     Development of the fetus/infant at birth and for the first 2 years will also be followed.   "
55685|NCT02556762|"     This randomized phase III trial is to compare simultaneous modulated accelerated boost with     standard dose radiotherapy given together with chemotherapy in treating patients with     esophageal squamous cell carcinoma.   "
55686|NCT02556749|"     The purpose of this study is to evaluate the effects of cranberry juice on central and     peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein     concentrations and size characteristics, and HDL function. The investigators hypothesize that     the bioactive compounds in cranberry juice may elicit beneficial effects on blood pressure     and arterial health, as well as LDL-C and HDL function.   "
55687|NCT02556736|"     RST-001 is a gene therapy given as an injection into the eye.   "
59206|NCT02510586|"     The aim of the present study is to evaluate the effect of sevoflurane postconditioning on the     incidence of postoperative hyperperfusion syndrome following revascularization surgery in     moyamoya patients.   "
55688|NCT02556723|"     Diabetic macular edema (DME), wet-AMD and macular edema secondary to vein occlusions are the     leading cause of blindness in developed countries. Several therapies have been studied as     such laser treatment and intravitreal injections of corticosteroids or anti-VEGF drugs. In     terms of public health the long term treatment with the current available drugs is very     expensive and new therapies with the same or better effect should be investigated. This study     intends to evaluate the efficacy and safety of intravitreal injections of ziv-aflibercept for     the treatment of patients with DME, wet-AMD and macular edema secondary to vein occlusions.   "
55689|NCT02556710|"     This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™     in adults with pain due to osteoarthritis of the knee   "
55690|NCT02556697|"     Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and     microvessels, characterized by the occurrence of fibrosis and vascular obliteration     phenomena. The alterations in lung microvessels are found in pulmonary involvement of     scleroderma, which are the most serious complications of the disease.      In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are     involved in the onset and development of the disease.      The confocal endomicroscopy is an endoscopic technique which can be performed during a     bronchoscopy. This technique makes it possible to observe in real time the most distal     pulmonary elements at the microscopic scale. After injection of fluorescein, then the     technique of observing the pulmonary microvasculature, in vivo and in situ.      The characterization of microvascular lesions in these two pathologies could improve     understanding of their mechanisms and ultimately improve the early management of patients.   "
55691|NCT02556684|"     A prospective cohort study design will be conducted. Patients with LABC who receive     chemotherapy will undergo physical examination, ultrasound, MRI, and BSGI at baseline,     midway, and at the completion of chemotherapy. Approximately 100 patients will be recruited     over a 2-year period. This study will give clinicians further insight into the usefulness of     ultrasound, MRI, and BSGI in monitoring treatment responses in patients with LABC. This could     potentially lead to changes in clinical management of these patients.   "
55743|NCT02556008|"     This is an open-label observational study of pure CBD for the treatment for 25 children with     intractable epilepsy. As pure CBD is not FDA approved, the investigators are conducting this     study via the FDA expanded access mechanism on a compassionate use basis. The target patient     population is children with severe refractory epilepsy who have exhausted all other     reasonable avenues of treatment. These are patients for whom the risks of a relatively     untested product are outweighed by the potential benefit. Using seizure-diaries maintained on     a routine clinical basis, seizure frequency will be assessed four weeks prior to initiation     of CBD, one month after CBD initiation, and at least every 3 months thereafter. CBD will be     administered as an adjunct to all current anti-epileptic therapies.   "
55692|NCT02556671|"     Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been     the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However,     inhibition of platelet activation and aggregation after DAPT varies greatly among patients.     Some clinical studies have demonstrated that patients with high on-treatment platelet     reactivity are at increased risk of major adverse cardiovascular events. Tailored     antiplatelet therapy seems offer an opportunity to improve outcomes after coronary stenting     by drug adjustment based on platelet function testing. Unfortunately, the results of 3 major     prospective trials (GRAVITAS, ARCTIC, TRIGGER PCI) of personalized antiplatelet therapy are     neutral. In these studies, platelet function was only assessed by a single measurement and a     single method early after the start of antiplatelet treatment. To test the stability of     platelet reactivity measurements over time among patients undergoing PCI, investigators use 3     methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status of     VASP, light transmittance aggregometry) for platelet function testing in 2 periods (~14days),     with maintenance doses of clopidogrel.   "
55693|NCT02556658|"     The purpose of this study is to evaluate if prediction of general anaesthesia level by the     Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip     fracture surgery.   "
55694|NCT02556645|"     The purpose of this randomized controlled trial is to compare the efficacy and potential     biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE),     Web-PE, delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT) delivered     over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to 170     individuals will be consented to obtain data from 120 for analysis. Participants will be     assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment completion.   "
55695|NCT02556632|"     This randomized pilot phase II trial studies and compares prophylactic topical agents in     reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or     breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR     Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss     and inflammation during radiation therapy.   "
55696|NCT02556619|"     The purpose of this research study is to evaluate the effect of early palliative care     consultation on quality of life, use of hospital resources, end-of-life care and survival     among Hepatocellular Carcinoma (HCC) patients with advanced End Stage Live Disease not     eligible for potentially curative or local area therapy. Half of patients will receive early     palliative care at diagnosis of HCC and other half will receive palliative care when all     standard therapy treatments have been exhausted.   "
55697|NCT02556606|"     The purpose of this study is to examine the effectiveness of a single infusion of ketamine     (KET), to determine which dose is optimal and lasts the longest, and to learn about how     ketamine works in the body and brain in persons with late-life treatment resistant     depression.   "
55698|NCT02556593|"     This study is to assess the efficacy of IMRT combined with erlotinib compared with     whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain     metastases.   "
55699|NCT02556580|"     The study aims to determine the degree of plasma volume expansion and the half-life of the     plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes     in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and     on the day after major surgery when the patient is in a post surgical inflammatory state. The     study also examines the increase in the plasma colloid osmotic pressure as a result of this     infusion and its possible influence on markers of kidney damage.   "
55700|NCT02556567|"     This is a research study to find associations between asthma symptoms and sleep patterns and     physical activity among adolescent patients with persistent asthma. The Investigators will     collect Fitbit® sensor data and survey data from each adolescent enrolled in the study.   "
55701|NCT02556554|"     A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the     role of continuous glucose monitor (CGM) use either alone or with remote monitoring     capabilities during pregnancy associated with T1DM.   "
78842|NCT02253862|"     Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200     mg on the single-dose pharmacokinetics of tadalafil 10 mg   "
55702|NCT02556541|"     The purpose of this investigation is to conduct a randomized, patient-blinded prospective     controlled trial comparing peripheral intravenous cannulation in children done by:        1. Conventional landmark cannulation where the intravenous cannulation is done by direct          visual guidance or palpation or a combination thereof.        2. Ultrasound guided cannulation by means of DNTP.      The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation     the first-attempt success rate will be significantly higher than by the conventional landmark     cannulation technique.   "
55703|NCT02556528|"     This is a study to assess the feasibility of using health coaching sessions in cancer     patients. The investigators are investigating whether health coaching sessions can be     delivered to this group of participants in a semi structured way. The investigators hope that     the study will allow us to see whether such sessions can be delivered in a timely manner that     is acceptable to patients and staff. The longer term aim for this work, should it prove     feasible, is to conduct a randomised controlled trial to assess health coaching.      The participants for the study will be selected using purposive sampling. The investigators     will select a sample of 10 patients. The participants will be patients at the Oxford     University Hospitals NHS Trust who are prescribed oral anticancer therapy. The sample will     include male and female patients and try to cover a range of ages from 18 upwards. It will     cover patients taking a range of oral anticancer agents, for a range of different cancer     indications. The sample will look at patients who are newly prescribed oral anticancer     therapy through to patients who have been taking therapy for years.      Participants will be identified for the study by multidisciplinary staff members who are     running oral education sessions or by non-medical prescribers who are seeing patients in     clinic. These members of the MDT will be given lists of the types of participants the     investigators are looking for in the study and where appropriate offer patients the     opportunity to take part. Patients will be contacted prior to the end of their subsequent     cycle of treatment about whether they wish to participate. Patients wishing to take part will     be consented at their next clinic visit.      All participants will attend for their usual clinic visits throughout the study. Participants     will additionally be offered up to 3 health coaching sessions for a maximum of three cycles     or until treatment with their oral anticancer agent ends, whichever comes first.      At the end of study visit participants will be asked to attend a qualitative based interview     to discuss the intervention.   "
55829|NCT02554864|"     The adductor canal block (ACB) is the standard of care for analgesia after Anterior Cruciate     Ligament (ACL) repair. ACB is performed by injecting local anesthetic (freezing) in the     subsartorial canal in the thigh which is about 7-10cm long. Preliminary evidence suggests     that different injection sites within the canal may produce different degrees of analgesia     and quadriceps motor block. This trial seeks to determine the effects of various ACB     injection sites on postoperative analgesia and motor power following ACL repair.   "
55705|NCT02556502|"     The diagnosis of Alzheimer's disease (AD) is based on clinical and neuropathological     criteria.      Some patients have a contributive CSF biology to determinate a high level risk of AD (Tau +     phospho-tau ratio increased and Ab42 / decreased Aβ40), but others have an intermediate CSF     biology (Tau and/or phospho-tau increased but Ab42 ratio / normal Aβ40) and are     unclassifiable.      18F-Florbetaben (Neuraceq®), a radioisotope in positron emission tomography (PET),     selectively binds to amyloid plaques, with high detection sensitivity (98%).      Detection of amyloid plaques by PET imaging separate patients according to the criteria of     Dubois, as with AD and allow them to benefit a cholinesterase inhibitor treatment.      If negative, the diagnosis of AD can be excluded with a high level of confidence to prevent     initiating unnecessary treatment, expensive for the community.      This is the first imaging study of amyloid plaques targeting population whose diagnosis of AD     is uncertain according to the CSF biology.      The aim of this study is to describe the results of amyloid PET in case of intermediate CSF     biology and to separate patients as AD or not according to the criteria of Dubois   "
55706|NCT02556489|"     Analyse the transcriptomic signature of anti vaccinia memory B cells at a short time after     vaccination as compared to the signature already established in long-lived memory B cells.   "
55707|NCT02556476|"     The purpose of this study was to examine the cost effectiveness of critical care in a middle     income country with limited resources.      The main study hypothesis was that critical care is cost effective in low resources setting.   "
55708|NCT02556463|"     To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid     tumors or CTCL, and in combination with durvalumab and/or palliative radiation in subjects     with solid tumors.   "
55709|NCT02556450|"     Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed.     Prevention is most efficient when directed toward patients at risk and when mechanistically     targeted to patients most likely to respond. An increase in myocardial and possibly vascular     collagen content (fibrosis) may be a major determinant of the transition to HF. In patients     with hypertension and diabetes, two important risk-factors for HF, changes in blood markers     of fibrosis occur before clinically overt HF develops. These markers are also related to     prognosis.      In the general population, Galectin-3 (Gal-3), a potential marker of fibrosis, is associated     with cardiovascular (CV) risk factors, and predicts development of HF. In animal models,     Gal-3 is a key mediator of aldosterone-induced CV and renal fibrosis and dysfunction.      The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA),     spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in     patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of     spironolactone might be superior in patients with a higher compared to lower plasma     concentrations of Gal-3.      Main objective is to investigate whether spironolactone can favourably alter extra-cellular     matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III     N-Terminal Peptide (PIIINP), in patients at increased risk of developing heart failure and     whether this effect is greater in patients with increased plasma concentrations of Gal-3.   "
55710|NCT02556437|"     The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin     10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment     in patients with Multifocal Motor Neuropathy (MMN).   "
55711|NCT02556424|"     Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the     therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only     triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially     for rheumatological or dermatological use, has been increasingly deployed in ophthalmology,     while still off-label.      In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into     the vitreous cavity obtained the label for inflammatory macular edema. This protocol is     therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of     corticosteroids in the treatment of inflammatory macular edema.   "
79469|NCT02245698|"     The purpose of this study was to study the safety and effect of stem cell therapy on the     functional recovery in patients with sub acute/chronic stroke.   "
55712|NCT02556411|"     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of     the uterus. It affects about 15-20% of the female population.      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation     (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment     levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues,     Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study     is to compare the efficacy and usefulness of association of oral contraceptive pill and     LNG-IUS or LNG-IUS alone   "
55713|NCT02556398|"     The project involve evaluation of a web-based nutrition education program and pilot-testing     of a new smartphone app for real-time data logging to identify factors causing glycemic     variability.   "
55714|NCT02556385|"     The aim of this study is to assess the safety and clinical efficacy of high or low-frequency     repetitive transcranial magnetic stimulation based on brain activation with functional near     infrared spectroscopy in poststroke nonfluent aphasia patients.   "
55715|NCT02556372|"     This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects     with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper     limit of normal (ULN) and who have had a failed response to, incomplete response to,     intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The     dose of JKB-122 will be escalated monthly.   "
55744|NCT02555995|"     Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique     ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular     degeneration (AMD).      This study assesses the scanning performance of a newly developed sparse OCT retina scanner     that is smaller and more compact than most commercially available medical OCT systems. The     prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.      In this study the device is first tested on human eyes. The scanning performance is compared     to a reference device. Additionally patient feedback during the examination is acquired.      The findings of this study are used to improve the software and the ergonomics of the     investigational device.   "
55716|NCT02556359|"     The molecular mechanisms participating in the various aspects of the DNA Damage Response     (DDR) are absolutely essential to maintain the genome dynamics essential to all living     organisms. The most commonly studied consequence of faulty DDR is genome instability     participating in cancer onset. In the present proposal, we wish to explore another aspect of     DDR, not relevant to cancer, which is its absolute requirement at several key steps of the     development, maturation, and function of the immune system.      The most spectacular consequences of faulty DNA repair processes with respect to the     immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to     defective DNA joining phase during V(D)J recombination resulting in patients with Severe     Combined Immune Deficiency (SCID).      The objectives of this study are to increase our knowledge on the role of the various DNA     repair processes in the development, the maintenance, and the function of the immune system     and thus, to better understand why and how dysfunctions of these DNA repair processes result     in human severe conditions such as CVID, LOCID or other manifestations of immune disorders     such as autoimmunity.      The explorations of DNA repair mechanisms in the patients will allow us to establish the     genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of     immediate importance for the patients and their families, as it not only contributes to a     better understanding of the patients' condition, but also allows providing genetic counseling     for the families.   "
55717|NCT02556346|"     This Phase I, multiple ascending dose study will seek to enroll subjects with     relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma     (SLL) with confirmed and measurable disease who have received standard treatment with at     least one anti-CD20 antibody (e.g.; rituximab, ofatumumab) containing front-line regimen that     resulted in initial response, followed by relapse/recurrence and who are not eligible for any     further approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or     refuse alternative approved therapies and/or are unlikely to achieve clinical benefit from     any therapy of higher priority by Investigator assessment.   "
55718|NCT02556333|"     Background:      HIV attacks the immune system. Antiretroviral therapy (ART) is a combination of drugs used     for treating HIV infection. For some people, ART drugs stop working against their HIV.     Researchers want to see if a different form of the drug tenofovir (an ART drug currently     approved by the FDA), combined with another drug, may help people whose HIV is resistant to     ART. This combination pill is called F/TAF      Objective:      To study the safety and efficacy of the drug F/TAF, when used with other ART, for people     whose HIV infection has been hard to control with available medicines.      Eligibility:      People age 14 years and older who have HIV infection and are enrolled in the DOTCOM     (14-I-0009) protocol.      Design:      Participants will be screened with physical exam, medical history, and blood and urine tests.      Participants will stay in the hospital for at least 10 days. For the first 9 days, they will     take F/TAF by mouth along with their usual ART drugs.      In the hospital, they will repeat the screening tests.      Participants will have a DEXA scan, an x-ray that measures calcium and other minerals in the     bones. Participants will lie on a soft table while the scanner passes over the lower spine     and hips.      Participants will get a supply of F/TAF and some new ART drugs to take at home.      Participants will have follow-up visits in 1, 2, 4, 8, and 12 weeks. After the 12-week visit,     they will come back about every 3 months for about 1 year.      At these visits, participants will repeat the screening tests. They will discuss any problems     taking their ART drugs. They may have another DEXA scan.   "
55719|NCT02556320|"     A recent study has shown that certain drug allergies were actually related to an immune     system against certain viruses. The aim of the study is to evaluate, in patients taking     antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily     an immune response that would promote the development of a rash. In particular, will be     studied whether these drugs can induce virus reactivation dormant in the immune system.     This study will not affect the usual follow-up proposed by investigators, with the exception     of some additional blood samples.   "
55720|NCT02556307|"     In this Slovenian, multi-center, observational study, the effectiveness of standard of care     Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC)     is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating     physician, followed by a 24-week follow-up period.   "
55721|NCT02556294|"     India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an     identified high risk group. MSM in India face unique psychosocial stress underlying the     context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the     purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a     behavioral intervention that addresses both psychosocial / contextual stress and reducing     participant's risk for HIV.   "
57551|NCT02532257|"     The goal of this clinical research study is to learn if adding Imbruvica (ibrutinib) to     Rituxan (rituximab) and Revlimid (lenalidomide) can help to control previously untreated     follicular lymphoma (FL) and marginal zone lymphoma.   "
55732|NCT02556151|"     Fecal Incontinence (FI) affects 8-15 % of the US population, predominantly women and elderly,     and 45% of nursing home residents. It significantly impairs quality of life and poses a major     health care burden. FI is characterized by significant neuromuscular dysfunction of the     pelvic floor that includes bilateral lumbo-anorectal and sacro-anorectal neuropathy and     sensori-motor dysfunction. This multifactorial etiology suggests that maladaptive     neuroplastic changes in the neural innervation of lower gastrointestinal tract could play a     significant role in the pathogenesis of FI. A critical barrier to progress in the treatment     of FI is the lack of understanding of how treatments affect the core pathophysiological     mechanisms of FI, and the absence of mechanistically based non-invasive therapies. Our goal     is to address the problem of FI by developing therapies that modulate peripheral and central     neuronal perturbations and thereby improve visceromotor control and sensori-motor     dysfunctions, and to understand the neurobiologic basis of these treatments. Our central     hypothesis is that a novel non-invasive treatment consisting of repetitive translumbar     magnetic stimulation (rTLMS) and repetitive transsacral magnetic stimulation (rTSMS) will     significantly improve FI by enhancing peripheral and central neural excitability and will     provide a multidimensional therapeutic benefit- enhance anal muscle strength, improve stool     perception and improve rectal capacity. Our approach is based on our preliminary studies     which suggest that repetitive translumbar magnetic stimulation (rTLMS) and transsacral     magnetic stimulation (rTSMS) improve anorectal pain and neuropathy and induce central     neuroplastic changes.      Our objectives are to:        1. address the significant gap in our knowledge regarding the peripheral and central          neuroenteric axis and how perturbations in the afferent and efferent neural signaling          can affect FI;        2. develop a new treatment for FI with repetitive magnetic stimulation and determine the          feasibility, safety and optimal frequency setting of rTLMS and rTSMS;        3. determine the mechanistic basis for this neuromodulation therapy;        4. identify if the locus for improvement lies in the afferent or efferent signaling or          both.   "
55733|NCT02556138|"     The purpose of this study is to determine whether the ORBERA Intragastric Balloon is a safe     and effective means for weight loss and improved metabolic disease in patients with cirrhosis     requiring liver transplantation.   "
55722|NCT02556281|"     After curative surgical resection, detection of metastatic lymph node remains the main     prognostic validated criteria on which is based the decision of adjuvant therapy. To date,     none of the molecular alterations, identified as potentially predictive factor, are used in     routine for therapeutic decision. The circulating markers, either in the form of free     circulating DNA or in the form of circulating tumoral cells seems important potential     candidates. To investigators knowledge, only one study estimated with several interesting     results the prognostic interest of a coupled detection of the free circulating mutant DNA     (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain     however difficult to achieve because of the small number of patient included (n=58) and the     fact that this study included different stages. For colorectal cancer a Chinese team     presented a series of results suggesting that the presence of CTC during the postoperative     course is a factor significantly related to the risk of recurrence. In multivariate analysis     integrating the lymph node status and the vascular invasion, the presence of CTC appeared as     an independent factor for recurrence with a hazard ratio of 29.5.      The aim of the present study is to compare the prognostic value of two circulating tumoral     markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating     tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two     circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival     rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA     and circulating tumoral cells in localised colorectal cancer.   "
55723|NCT02556268|"     To investigate the pharmacokinetic drug-drug interaction potential of fixed dose     antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved     antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure     to riociguat in HIV patients on a stable dose of one of these therapies.      • To Assess the safety and tolerability of riociguat treatment in combination with these     fixed-dose antiretroviral therapies.   "
55724|NCT02556255|"     The aim of the study is to assess the safety and efficacy of the use of the Eximo's CathiTM     hybrid catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity     arteries.   "
55725|NCT02556242|"     Since 2000, annual numbers of malaria cases in South Africa have sharply declined to about     5,000, with case numbers fairly stable since 2007. The principal malaria prevention strategy     has consisted of generalised Indoor Residual Spraying (IRS) of all houses in malaria endemic     districts. As recent case data indicate that the levels of transmission in many districts     have been reduced to very low levels, the continuation of untargeted IRS in areas where there     is little or no evidence of recent transmission may be unwarranted. Efforts to eliminate     malaria will only be sustainable if mass prevention efforts can be scaled down in an     evidence-based manner, whilst maintaining or enhancing high sensitivity of the surveillance     system of the disease. This trial will provide scientific evidence for targeted malaria     prevention responding to localised transmission in pre-elimination settings, compared to     continuation of generalised IRS of all houses.      Two methods of IRS delivery for community malaria prevention will be compared through an     open-label cluster-randomised trial consisting of two study arms with 30 clusters per arm of     approximately 8,000 inhabitants per cluster.      Comparison is on the basis of non-inferiority by showing that malaria incidence in the     targeted IRS arm is no higher than malaria incidence in the generalised IRS arm within a     specified margin of difference, and on the basis of superiority showing that the proportion     of houses targeted for spraying is higher in the intervention than the reference arm.     Neighbourhood investigation in response to two cases in the intervention arm, and comparison     neighbourhoods in the reference arm, will include testing for antibody sero-conversion to     malarial antigens to assess whether cases arise in communities with long term exposure to     malaria parasites.      The trial will be carried out in the South African provinces of Limpopo and Mpumalanga, in     localities which have average reported incidence of malaria of <5 cases per 1000 per annum     over the past five years.   "
55726|NCT02556229|"     Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and     Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment     should not be delayed.      InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)     therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated     in AMD. Case reports suggest that such patients would not need as many injections as in AMD.      ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment     with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage     regimen is designed to achieve maximum efficiency. The patients are followed on a monthly     basis until 52 weeks. The first injection is mandatory. The other ones are injected only in     case of active InCNV.   "
55727|NCT02556216|"     Bone and mineral disease is a key problem in patients with kidney disease. The available     clinical parameters are non-specific, unproven for the assessment of the bone metabolism and     do not reflect the complexity and diversity of the underlying bone pathology. The aim of this     study is to use bone histology, novel bone markers and bone imaging results to establish a     reliable decision model (diagnostic tool) that can be used to guide the individual therapy.   "
55728|NCT02556203|"     To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR,     compared to an antiplatelet-based strategy, is superior in reducing death or first     thromboembolic events (DTE).      To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an     antiplateletbased strategy, following TAVR.   "
55729|NCT02556190|"     The emergence of multidrug-resistant bacteria has recently renewed interest in colistin. Data     on dosing in critically ill patients undergoing extended dialysis are missing. The aim of     this study is to determine the pharmacokinetics of colistin during extended dialysis in     critically ill patients and to provide dosing guidelines for this drug.   "
55730|NCT02556177|"     This is an open-label, non-randomized, prospective, multi-site, parallel group (segment),     hypothesis-generating study designed to collect data that will aid in future scientific and     engineering exploration of correlations between clinical neuropsychological assessments and     GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended     for scientific inquiry and engineering development purposes, and may be used in future     regulatory submissions.   "
55731|NCT02556164|"     Gait and balance disorders, key contributors to fall and poor quality of life, represent a     major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of     acupuncture in recent years in PD, its efficacy remains unclear, largely due to     methodological flaws and lack of high quality studies using objective outcome measures. In a     patient and assessor-blind pilot study, investigators objectively assess the efficacy of     electroacupuncture (EA) for gait and balance disorders using body-worn sensor technology in     patients with PD.   "
80797|NCT02228343|"     Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk     factors in patients with coronary artery disease.   "
55734|NCT02556125|"     Respiratory dysfunction is the leading cause of death in individuals with spinal cord     injuries (SCIs). Nearly one quarter of all SCI cases involve injury to the upper spinal cord     segments which impairs neural activation of the diaphragm muscle and compromises breathing.     Although mechanical ventilation can be life-saving after cervical SCI (C-SCI), it also     triggers rapid and profound diaphragm muscle atrophy, thereby complicating (or even     preventing) ventilator weaning. Intramuscular diaphragm stimulation, or diaphragm pacing, was     developed to replace long-term ventilator support, and is now used acutely post C-SCI (<4     months following injury) to promote ventilator weaning. The impact of diaphragm pacing on     respiratory function and diaphragm muscle activation has not been formally evaluated. This is     an essential step in determining the efficacy of intramuscular diaphragm stimulation and its     effects on respiratory function after SCI. Accordingly, this research study will evaluate the     effects of intramuscular diaphragm stimulation and test the hypothesis that diaphragm pacing     enhances neuromuscular diaphragm activation and respiratory function in adults with cervical     SCIs. The investigators will test the hypothesis by evaluating the effects of diaphragm     pacing on neuromuscular activation of the diaphragm by directly recording electromyogram     (EMG) activity from the intramuscular pacing electrodes. Recording from these     surgically-implanted electrodes allows direct comparisons of EMG activity across time,     minimizing methodological limitations inherent with surface or percutaneous EMG recordings.     This approach, in association with respiratory assessments, will be used to investigate the     impact of diaphragm pacing in adults with intramuscular diaphragm pacing electrodes following     acute, traumatic C-SCIs.   "
55735|NCT02556112|"     With this study researchers will evaluate the effects of the GLB intervention on weight loss,     chronic disease indicators and self-perceived function and well-being in an active duty     population. The purpose of this study is to examine the effectiveness of the GLB program     [compared with two currently available programs, the Fitness Improvement Program (FIP) and     the Better Body Better Life (BBBL) program], on the following health indicators: improvement     of individual physical fitness as measured by change in abdominal circumference, weight and     physical activity; decrease in risk associated with chronic disease as measured by changes in     lipid and HbA1c levels; and improvement in self-perceived function and well-being as measured     by the RAND 36 Item Short Form Health Survey (RAND SF- 36). In addition, the researchers seek     to obtain feedback about the programs from the participants.   "
55736|NCT02556099|"     The primary goal of the Phase II EXTEND trial is to investigate the effects of open-label     hydroxyurea treatment, escalated to maximum tolerated dose, for children with Sickle Cell     Anemia and either conditional (170 - 199 cm/sec) or abnormal (≥200 cm/sec) Transcranial     Doppler velocities. The primary endpoint will be measured after 18 months of hydroxyurea but     treatment will continue until a common study termination date.   "
55737|NCT02556086|"     The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and     sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated     previously without liver cirrhosis who are chronically infected with hepatitis C virus     (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.   "
55738|NCT02556073|"     Poor adherence to asthma controller medication may link to poor asthma outcome. A metered     dose device with built-in dose counter helps physicians to monitor drug compliance in asthma     patients. Mobile-phone based self management opens a window for better asthma control. The     present study aims to investigate the relationship between the adherence to controller     medication of combined inhaled corticosteroid/long acting beta2-agonists, assessing by     integrated dose counter, and the level of airway inflammation and asthma control. Moreover,     the investigators also use a new asthma self-management Apps to enhance drug compliance. With     the application of the new, easily available tools, the investigator expect to increase     adherence rates, and hence, to reduce airway inflammation and improve the level of asthma     control.   "
55739|NCT02556060|"     The purpose of this study is to investigate the efficacy of lamotrigine in the treatment of     ketamine dependence in a double-blind, placebo controlled design.   "
55762|NCT02555748|"     This pilot study is an open-label interventional study, prospective, non-comparative,     sequential (two stages), national, multicenter study.      Patients starting therapy with sunitinib or pazopanib as standard first line treatment for     advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts     (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).      The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose     individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of     this approach in terms of tolerance and efficacy compared with the current empirical method     based only on tolerance observation.   "
55806|NCT02555163|"     Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor     (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT)     in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness     of tumor resection and peri procedure complication.   "
55740|NCT02556047|"     Several vaccinations are administered by the intradermal (ID) method where the vaccine is     injected between layers of skin. The current technique required to do this can be difficult     to learn and perform accurately, is slower to deliver than subcutaneous or intramuscular     injections, and there is a risk that the injection will be given to too-deep skin layers or     to underlying tissues, which might change the immune response. There is increasing interest     in using ID administration for vaccines as it may be possible to achieve the same immune     response with a smaller dose of vaccine. This could increase access to vaccines that are     expensive or are only available in small quantities and therefore could have global health     benefit for vaccine programs for diseases such as yellow fever and polio.      Because of the potential global-health benefits of being able to give ID injections of     vaccines easily, quickly and with relatively little training or experience, several novel     devices are currently being developed to allow easy ID administration. Star Syringe have     developed two novel intradermal safety devices that differ only in the length of the needle     used. The current study will assess how the two new devices perform, compared to the     traditional Mantoux test, using injections of saline into the upper arm. Twenty volunteers     (18-60 years, male and female) will be recruited and attend a screening visit (1), an     injection visit (2a) and have a follow up telephone call (2b). At the injection visit they     will receive 3 injections in each arm (Mantoux and 2 device injections) and measurements will     be performed.      A subset of volunteers will be invited back to attend an additional visit (3a) which will be     a repeat of visit 2 but with an ultrasound image taken of each injection site. There will be     a follow up telephone call 24 hours later (3b).   "
55741|NCT02556034|"     This study will establish a comparison in follow-up care of 100 patients between Health Care     Practitioners, more specifically the rheumatologist and a trained nurse. The study objective     is to show consistency of evaluation between two different health care professionals, a     physician and a nurse.   "
55745|NCT02555982|"     Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or     primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis     intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of     blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses,     leading to a reduction of pathological muscle movement. Very little information is available     on its efficacy on HT. Two published reports suggested that local Btx A injections could be     an effective and safe approach for treating HT. Given the scarcity of published data (small     samples, open studies, different doses of Btx used, heterogeneous populations, several     muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx     injections in essential HT by a multi-center, randomized, double-blind, parallel-group,     placebo-controlled study.      Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment     of head tremor.      Secondary objectives:        -  - To evaluate the tolerance of botulinum toxin injections in the treatment of head          tremor.        -  - To evaluate the impact of botulinum toxin injections on the patients' quality of life          and embarrassment.        -  To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D          accelerometer wireless portable system (Xsens MTw wireless motion tracker system)          (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a          new video system device to analyze head tremor characteristics   "
55746|NCT02555969|"     This protocol will assess patients with AL amyloidosis who achieve a complete response (CR)     or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three     approaches to MRD testing will be used since there is no established method. The     investigators will clone and sequence each patient's light chain (LC) gene and design     patient-specific primers to evaluate genomic DNA from future marrow specimens. Whole genome     sequencing (WGS) will be used to test baseline and follow-up marrow cell DNA, seeking copy     number variations in chromosomes 1 and 2 or 22, and structural variations in chromosomes 11     and 14, consistent with the known genetic abnormalities in AL and with clonal LC gene use.     Plasma protein analysis by mass spectrometry will also be used to look for fragmentary     protein sequences associated with the culprit LC gene of each subject. The feasibility and     predictive value of these three approaches in patients achieving CR or VGPR will be     evaluated. This protocol will help provide insight into the ways that the disease changes and     progresses. MRD testing is likely an important next step in AL management.   "
55747|NCT02555956|"     Diabetic related complications are increasing day by day due to increse in the number of     diabetic patients all over the world. Diabetic macular edema is one of them and a major cause     of vision imparment. Various kind of treatment modalities are preent to treat this     coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive     procedure.Laser power if kept to aminimum can get the desired results without severe     destruction to the retina . In this study, the investigators are going to document the effect     of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.   "
55748|NCT02555943|"     This is a prospective study to determine the incidence, morbidity, mortality and predisposing     factors for the reactivation of hepatitis B virus replication during direct anti-HCV     treatment of HCV/HBV co-infection patients.   "
81720|NCT02216318|"     to investigate the effect of two lightning conditions on sleep hypothesizing that sleep     length is influenced by the color of light during daytime   "
55749|NCT02555930|"     HIV associated sensory neuropathy (HIV-SN) is a frequent complication of HIV infection,     affecting between 20 and 57% of infected individuals. The advent of better antiretroviral     treatment for HIV has meant that mortality from HIV has decreased dramatically in the UK.     This means however, that chronic, age-related conditions associated with HIV, such as HIV-SN     and cognitive impairment, are increasing in prevalence and becoming a significant disease     burden.      The classification, diagnosis and treatment of HIV-SN remains poor. Currently, little is     known about the genetic basis of the disorder and what risk factors mean that some patients     with HIV develop neuropathy and pain, whilst others do not. It is hoped that by further     characterising or 'phenotyping' the disorder, it will be easier to identify which patients     are at risk of developing neuropathy and chronic pain. It may also mean that treatment can be     more individualised as currently patients often undergo a frustrating 'trial and error'     protocol of treatment, as clinicians can not yet predict who will respond to which treatment.      It has also been suggested that there is a link between HIV-SN and HIV associated     neurocognitive disorder (HAND), which is another common, age-related complication of HIV     infection. It may be that the existence of one pathology could predict the development of the     other, or that the presence of HAND may impair the diagnosis or treatment of chronic pain     associated with HIV-SN.      This study aims to recruit a cohort of HIV patients with and without HIV-SN and to identify     genetic risk factors for the development of HIV-SN and neuropathic pain. It also aims to more     deeply phenotype the condition, using well validated questionnaires, and to identify any     influence that early neurocognitive dysfunction may have on the reporting, diagnosis and     treatment of neuropathic pain in the HIV population.   "
55750|NCT02555917|"     Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate     ligament complete rupture leads to knee joint instability and degenerative change of the     knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and     it gives excellent results. For leading to successful result of anterior cruciate ligament     reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. If     selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of     transplanted tendon, loss of range of motion, instability, failure of transplantation and     risk of arthritis. It is known that selection of inappropriate tibial tunnel location is the     most common cause of anterior cruciate ligament reconstruction failure.      Recently many studies reconstructed at anatomical lesion instead of isometric point. And some     cadaver studies reported that tibial insertion of anterior cruciate ligament has C shape.     There are two methods for anterior cruciate ligament reconstruction. One is preserving     remnant and the other is removing remnant.      This study aims to compare the tibia and femoral tunnel location of remnant preserving and     remnant resecting anterior cruciate ligament reconstruction.   "
55751|NCT02555904|"     This is an observational, single center study to evaluate if acoustic and accelerometer-based     measures of voice and speech have sufficient precision to detect a change in lung fluid     status for patients with confirmed acute heart failure syndrome with pulmonary congestion.     The study shall be conducted in concordance with the United States FDA regulations for a     non-significant risk study. Patients admitted for acute heart failure syndrome with pulmonary     congestion with an expected stay greater than 3 to 4 days, who are willing and able to sign     an informed consent, and who meet all inclusion/exclusion criteria, as identified by the     clinical investigator, will be enrolled in the study. Results of this study will evaluate the     sensitivity of voice and speech measures in detecting changes in lung fluid status in a     symptomatic population. Up to 12 subjects will be enrolled to comparatively evaluate the     voice outcome measures in this pilot study.   "
55752|NCT02555891|"     The overall objective of the present study will be to describe the occurrence of Potentially     Inappropriate Prescribing (PIP) in Ontario's elderly (>65 yrs) population, assess the health     and economic burden associated with it, and evaluate interventions aimed at mitigating its     effects.      To attain this objective, the investigators will test three specific hypotheses:      Hypothesis 1: Instances of Potentially Inappropriate Prescribing are frequent and costly. To     test this hypothesis, the investigators will apply a subset of the STOPP criteria and Beers     criteria to Ontario health administrative data to identify instances of potentially     inappropriate prescribing, and estimate potential savings, both direct and indirect, that     could be achieved by reducing inappropriate prescribing.      Hypothesis 2: ED visits and hospitalizations are significantly associated with Potentially     Inappropriate Prescribing. To test this hypothesis, the investigators will estimate the     attributable fraction of ER visits and hospitalizations associated with different frequencies     of PIP using multivariate methods and survival analysis.      Hypothesis 3: The likelihood of inappropriate prescribing is associated with patient and     physician characteristics. To test this hypothesis, the investigators will identify each     physician's annual PIP incidence density, calculated by dividing the number of PIP they     issued by the total number of prescriptions they provided over the study period and then     explore the association of patient and physician level covariates with patient outcomes.      The investigators will test these hypotheses in the framework of a retrospective cohort study     which the investigators will conduct using Ontario's large health administrative and     population databases. These are housed at the Institute for Clinical Evaluative Sciences     (ICES) and contain information on both hospital and outpatient use of health services, as     well as demographic and socioeconomic data. Patients included in the study will be all OHIP     (Ontario Health Insurance Plan) eligible patients aged 66 yrs of age and older who have been     issued at least one prescription between April 1st 2003 and March 31st 2013.      The investigator team, housed at ICES@uOttawa, has extensive experience and expertise with     the analysis of these databases, and has the support and resources necessary to successfully     carry out this study.   "
55753|NCT02555878|"     The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for     reducing the risk of the primary composite outcome as defined by objectively confirmed     symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity     proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE),     incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult     participants with various cancer types receiving systemic cancer therapy who are at high risk     of developing a VTE.   "
55754|NCT02555865|"     This multicenter retrospective observation study is designed to investigate the etiology of     children with bronchiectasis by review the medical records.   "
55755|NCT02555852|"     The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication     used to treat gastric conditions, increase the risk of hospitalization for community-acquired     pneumonia (HCAP).      The investigators will carry out separate population-based cohort studies using     administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort     entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug, with     follow-up until hospitalization for pneumonia or end of follow-up (6 months). The results     from the separate sites will be combined using a statistical approach called meta-analysis to     provide an overall assessment of the risk of HCAP with PPIs.   "
55756|NCT02555839|"     There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously     treated with Lenalidomide and Bortezomib, due to poor prognosis.      This observational study focuses on the collection of data concerning the safe and optimal     usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the     knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage     and efficacy will be performed.      This knowledge could lead to a optimization of Pomalidomide usage and treatment.   "
55779|NCT02555527|"     To perform a cost-effectiveness analysis for the routine use of contrast in rest     echocardiography in patients with dilated or ischemic cardiomyopathy from the United States     healthcare system, provider and payer perspectives.   "
81721|NCT02216305|"     HYPOTHESIS        1. HAL- RAR causes a lower immediate postoperative pain compared with erxcision          hemorrhoidectomy.        2. HAL - RAR achieves similar immediate and long term results compared to the excision          hemorrhoidectomy in the control of hemorrhoidal symptoms.        3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.      OBJECTIVES        1. Compare postoperative pain of both techniques.        2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique,          and compare the results with those of the excision hemorrhoidectomy.        3. Evaluate and compare the rate of complications of both techniques.        4. Assess the quality of life of patients before and after treatment.      MATERIAL AND METHODS      The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació     Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation).      All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with     both methods who agree to participate in the study, will be included in the prospective     randomized trial. All patients will be required to sign the specific informed consent.      Patients who are suitable for treatment with both techniques will be randomly assigned to the     surgical technique.      Inclusion criteria:      1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or     prolapse) that are eligible for surgical treatment with both methods.      Exclusion criteria:        1. Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure,          perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal          stenosis.        2. Prior anorectal surgery .        3. Systemic pathology that could alter the outcome of the surgery as coagulopathies,          chronic pain with continued consumption of analgesics.        4. Age younger than 18 or older than 80 years, socio-pathology or inability to understand          the study objectives.      All surgeries are performed on an outpatient basis under regional anesthesia and sedation for     the same team of three surgeons. Preoperative preparation consists of a cleansing enema and     no prophylactic antibiotics will be administered.      Both techniques will be performed in Jack -Knife position. The open hemorrhoidectomy may     include one to three anal cushions and made according to the Milligan-Morgan technique, with     resection of the anal cushion and the external hemorrhoidal epidermal component using     electrocautery and ligation of the hemorroidal base with absorbable suture. Once completed     hemorrhoidectomy a perianal block is performed with bupivacaine/epinephrine.      Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally     invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the     superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the     blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently,     a running suture was added from the suture point to 5 mm above the dentate line to lift the     prolapsing hemorroid. Other procedures will not be associated, if necessary, the patient will     be excluded from the study .      The patient will be discharged if adequate pain control, oral tolerance and spontaneous     diuresis is achieved, and after examination by the surgeon in order to discard immediate     complications. The ambulatory treatment consists of an osmotic laxative (magnesium hydroxide     ), oral analgesia with paracetamol/tramadol ( 325mg/37.5mg ) every 6 hours and Dexketoprofen     (25 mg) every 8 hours, metamizol (575 mg) may be associated every 8 hours if pain. In case of     persistent pain, the patient will be examinated in emergency room.      EVALUATION OF RESULTS A power analysis was performed to assess the study sample size.     Choosing a power of 0.8 and a confidence interval of 95% α-error of 0.05, we calculated that     26 patients were needed in each arm. We increased this number up to 30 to increase     reliability of the study.      All patients will be evaluated with a validated questionnaire of 36 questions on quality of     life ( SF-36 ) and specific questions about specific symptoms of hemorrhoidal disease (pain,     itching , bleeding, soiling and hemorrhoidal prolapse reduction ). The questionnaire will be     answered before the intervention, after six and twelve months of follow up.      All patients will complete a diary testing global postoperative pain every day, measured on a     numerical scale from 0 to 10 during the first 15 days.      The patients will be assessed on the day of discharge and at 7, 14, and 30 postoperative     days. The patients will be evaluated at 6, 12 and 24 postoperative months in the outpatient     clinic.   "
55763|NCT02555735|"     This is an observational study enrolling patients with metastatic pancreatic cancer to     identify genomic differences between exceptional responder and non-responders to standard of     care chemotherapy. Data analysis of the gene expression profile of the exceptional responders     compared to non-responders will define genomic patterns that may help understand their     response to chemotherapy.   "
55764|NCT02555722|"     This study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized,     lens blocked (subjects remain in the same lens brand throughout the study) concurrent control     study enrolling up to 90 subjects with a study duration of approximately three months.     Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of     fanfilcon A lens (test) to enfilcon A lens (control).   "
55765|NCT02555709|"     This is a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742     will be administered to normal healthy volunteers (NHV) and to moderate to severe psoriatic     patients, both in sequential ascending dose panels.   "
55766|NCT02555696|"     This observational project is collecting tolerability, safety and efficacy data with the     routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on     the dosage of Abraxane and general data on the disease and the health status of the patient     will be collected.   "
55767|NCT02555683|"     This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared     with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA     2015) in each of the groups (patients with severe asthma and high eosinophil counts and all     patients with severe asthma).   "
55768|NCT02555670|"     Aim of the present study is to determine whether muscle mass as assessed by bioelectrical     impedance analysis correlates with and corresponds to muscle mass as assessed by CT scan     analysis in critically patients admitted to the intensive care unit.   "
55769|NCT02555657|"     In this study, participants with metastatic triple negative breast cancer (mTNBC) will be     randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy     chosen by the treating physician (TPC) in accordance with local regulations and guidelines,     consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study     hypothesis is that pembrolizumab extends progression free and/or overall survival compared to     TPC   "
55770|NCT02555644|"     The main purpose of this study is to investigate the safety of prexasertib in combination     with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants     with locally advanced head and neck cancer. The study has two parts (A and B). Participants     will only enroll in one part.   "
55771|NCT02555631|"     The purpose of this two-year proposal is to:        1. develop and        2. complete a pilot test of an adaptation of the evidence-based National Diabetes          Prevention Program (NDPP) tailored to engage men with prediabetes in disadvantaged          communities in New York City.      The sites for this pilot study are New York City Parks and recreation centers. Study's main     outcome is weight loss of 5-7% baseline weight.   "
55775|NCT02555579|"     This is a study to determine if a simplified protein counting system, including the free     usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in     teens and adults with phenylketonuria (PKU).      Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to     participate in this study.      Subjects will be educated on the simplified system upon enrollment, and historical     phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about     their attitudes towards their current Phe counting system.   "
55776|NCT02555566|"     Endothelial lesions within the transplanted kidney are a major determinant of chronic     allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived     hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.      The main goal of the investigators' study is to evaluate whether genetic polymorphisms of     specific enzymes responsible for the bioavailability of EETs are associated with     post-transplant kidney function.      To this end, 80 kidney transplant recipients will be included. Prespecified genetic     polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined.     Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated     dilatation, EETs and circulating biomarkers of endothelial function will be measured in the     radial artery.      The expected results of this study to provide preliminary evidence supporting a beneficial     role of an increase in the bioavailability of EETs in kidney transplant recipients.   "
55777|NCT02555553|"     The purpose of the proposed Phase II STTR study is to test the primary efficacy of a novel     mobile app, 'Noom Monitor,' in a large population of binge eaters in the Kaiser Permanente     health care system relative to a well-established treatment as usual (TAU) control condition.     Noom Monitor facilitates the delivery of CBT-GSH by utilizing a patient interface that     increases adherence and provides between-session reminders of CBT-GSH principles. In     addition, the Noom Monitor includes a therapist interface with weekly feedback to the     provider about patient progress. This application has several primary objectives, including:     (1) testing the real-world effectiveness of the Noom Monitor in a clinical setting, and (2)     establishing a database of training materials for Noom Monitor. The knowledge gained from the     current study will contribute to our understanding of the role of new emerging mobile     technologies in augmenting existing treatments.   "
55778|NCT02555540|"     The purpose of this protocol is to generate a set of data that will be analysed by integrated     systems biology approach, for validation in subsequent clinical trials or in animal models.      240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of     Boostrix on Day 0, 20 will receive a placebo on Day 0.   "
55780|NCT02555514|"     The association between varus malalignment and dynamic knee loading / adduction moment and     progression of knee joint cartilage degeneration in the lateral compartment is unclear and     has not been studied in detail before. There is a need to identify relevant parameters     explaining this cause-effect relationship. It is the purpose of the study to correlate load     changes in knee joints with biomechanical and biochemical alterations in cartilage to     understand the underlying mechanism of load induced cartilage degeneration in patients. This     study will therefore include patients with different stages of knee OA with various     malalignments. Moreover, analyzing changes in cartilage morphology, radiography and MRI and     correlate those findings with alterations in biochemical parameters in cartilage, serum,     urine and synovial fluid will allow us to identify novel biomarkers for the onset and     progression of joint cartilage degeneration in varus malaligned knees.      The following hypotheses will be tested:        1. Knee joint cartilage degeneration progresses from medial to lateral in varus-aligned          knees.        2. External knee adduction moments in patients with isolated medial OA are higher when          compared with patients with OA of the medial and lateral compartment.        3. Morphological and mechanical properties of cartilage show different stages of          degeneration when comparing the mechanically stronger loaded medial with the lateral          compartment of the knee.        4. Histological and biochemical analysis of the cartilage indicate different stages of          degeneration when comparing the mechanically loaded medial with the lesser loaded          lateral compartment of the knee.        5. Synovial fluid analysis, as well as serum biomarkers of cartilage metabolism demonstrate          cartilage degeneration and are related to biomechanical determinants of OA in the knee.        6. Novel biomarkers (ECM, miRNA, cytokines, mitochondria related, mechanical determinants)          for varus-aligned knees can be identified.   "
55781|NCT02555501|"     The aim of the study was to evaluate the therapeutic action through the diameter of the     lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis     (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was     performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora     Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT +     LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own     control. Patients were masked about therapy performed on each side of the arch. The     evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the     lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect     magnitude calculated. The significance level was 5%. Statistically significant difference was     observed between the groups for the lesion diameter of the 6th to the 8th day (greater     regression of lesion size for the PDT + LLL group), which was confirmed by a difference     magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater     therapeutic effect when compared to LLL in reducing the severity of OM lesions.   "
55782|NCT02555488|"     The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and     Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with     periradicular lesion.   "
55783|NCT02555475|"     The Prime Study is a randomised trial investigating models of care for hepatitis C in the era     of direct acting antiviral (DAA) therapy. The study aims to compare outcomes of hepatitis C     care and DAA treatment provided in a primary health care service with a tertiary hospital.   "
55784|NCT02555462|"     Integration of the REM-verification within the fitting workflow will enable the hearing care     professional to easily run real ear measurements. The purpose of the two study parts is to     prove that an integrated cooperative system, consisting of fitting software and measurement     system, matches desired responses for certain stimuli faster, more reliably and more     precisely at the ear drums of hearing instrument wearers than current best practice     processes.   "
55785|NCT02555449|"     The purpose of this study is to measure how much of the specially prepared study drug,     LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it     takes the body to get rid of it.      Information about any side effects that may occur will also be collected.      Participants will stay at a clinical research unit (CRU). The study will last about 28 days     (check in to follow-up) for each participant.      This study is for research purposes only and is not intended to treat any medical condition.   "
55978|NCT02552901|"     Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value     (PDR) to assess liver function in normal patients as well as in patients with mild to severe     hepatic impairment compared to manual Serum ICG PDR.   "
55786|NCT02555423|"     The aim of the study is to determine the effectiveness of serratus place block in the control     of post-operative pain following mastectomy. The investigators will compare one group of     patients receiving serratus plane block and wound infiltration to a control group receiving a     saline injection into serratus anterior and wound infiltration with local anaesthetic only.     The investigators will compare our results to the National Mastectomy and Breast     Reconstruction Audit's reported rate of 6.2% of patients reporting severe pain following     mastectomy to see if there is an improvement of the national standard. In the serratus block     group, the investigators expect a 50% decrease in the number of patients who report severe     pain day one post operatively.   "
55787|NCT02555410|"     This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure     detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.   "
55788|NCT02555397|"     The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and     maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene     therapy in men with locally recurrent prostate cancer after definitive radiotherapy   "
55789|NCT02555384|"     Amblyopia, affects 4% of the population. In the presence of a normal retina and optic nerve,     the visual cortex does not develop normally secondary to the amblyopic eye being at a     disadvantage in the sensitive period such as in strabismus. Amblyopia is associated with     visuospatial disorders, and poor to absent stereopsis. Amblyopia is treated by occlusion of     the non- amblyopic eye in childhood. The present study aims to evaluate the effectiveness of     perceptual learning (PL), that is a training of visual drawing tasks (12 sessions of 30     Minutes duration) with crowding (c) for children with amblyopia compared to an amblyopic     control group with a placebo drawing task.      Arm 1: Crowded (PLc)- Training with small spacing Arm 2: Uncrowded (PLu)- Training with large     spacing Prior to this, a small group will help optimize parameters such as contrast and     distance of visual objects presented   "
55804|NCT02555189|"     This partially randomized phase IB/II trial studies the side effects and best dose of     ribociclib when given with enzalutamide and to see how well they work compared to     enzalutamide alone in treating patients with prostate cancer that does not respond to     treatment with hormones (hormone resistant), has spread from the primary site (place where it     started) to other places in the body (metastatic), is chemotherapy naïve, and retains     retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells.     Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of     testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works     better when given with or without ribociclib in treating patients with prostate cancer.   "
57385|NCT02534428|"     The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the     effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of     childhood atopic dermatitis over two consecutive six-week periods.   "
55791|NCT02555358|"     The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing     the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer     patients.   "
55792|NCT02555345|"     This study aims to identify and validate the gene expression differentials of peripheral     blood mononuclear cells and differential inflammation profiles and other aspects in classic     asthma, cough-variant asthma and eosinophilic bronchitis.   "
55793|NCT02555332|"     This study was conducted to analyze the role of TSH level and TPOAb status in early pregnancy     and use this information in assessment of the risk of gestational diabetes mellitus at     different weeks of gestation when the FT4 level is normal.   "
55794|NCT02555319|"     The purpose of this study is to evaluate the safety and short-term effectiveness of     implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart     disease with pulmonary valve disease.   "
55795|NCT02555306|"     The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and     bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with     refractory exudative age-related macular degeneration (AMD).   "
55796|NCT02555293|"     Surgery is in almost all cases the only potentially curative treatment option for patients     with primary or secondary malignancies of the liver. However, in most cases oncological     resections (R0-resections) can only be achieved by performing major liver resections (4 or     more liver segments), which is related to considerable postoperative complications such as     systemic infections and postoperative liver insufficiency (postresectional liver failure     (PRLF)). Despite optimized preoperative and postoperative strategies of care presently, up to     32-55% of patients display severs postoperative complications (Clavien score ≥ 3a) and 5%     even suffer from a severe PRLF. Recent observations in murine disease models as well as human     patients suggested that postoperative alterations of hemodynamics within the portal vein     tract as well as postoperative modulations of the immune response facilitates the     translocation of gut bacteria in the blood, leading to systemic infections and sepsis.     Moreover it became apparent that inflammatory mediators, released by the gut microbiota might     negatively affect postoperative liver regeneration. Rifaximin (Xifaxan®) is a novel and     potent, semisynthetic antibiotic that efficiently acts against most enteric bacteria and     significantly reduced liver inflammation and liver fibrosis in animal studies. Moreover,     Rifaximin is very well tolerated, even in patients with liver insufficiency.   "
55797|NCT02555280|"     A 2 and 5 year comparative evaluation of clinical outcomes in the treatment of degenerative     spinal stenosis with concomitant low back pain by decompression with and without additional     stabilization using the coflex® Interlaminar Technology for FDA Real Conditions of Use Study.   "
55798|NCT02555267|"     This study investigate the impact of comprehensive geriatric assessments using activity of     daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity     index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma     (DLBCL) treated with R-CHOP.   "
55799|NCT02555254|"     Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow     rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a     period of targeted temperature at 33°C after cardiac arrest supported by shockable rhythm and     successfully resuscitated.   "
55808|NCT02555137|"     This is a prospective, international, multicenter outcome cohort study. This study starts at     the moment patients visit the outpatient clinic 3 to 6 months after a diagnosis of acute PE     as part of routine medical care. If patients consent to study participation, the CTEPH     clinical prediction score will be calculated. CTEPH is considered to be not present in     patients with a low probability (≤6 points) and no symptoms suggestive of CTEPH, i.e. dyspnea     on exertion, edema, newly developed palpitations, syncope or chest pains.The remaining     patients with either high probability (>6 points) or who report symptoms that may be     associated with CTEPH will be subjected to the 'rule-out criteria'. CTEPH will be assumed not     present in patients with an age- and gender dependent normal NT-proBNP level (as defined by     the assay's manufacturer), in the absence of any of the 3 ECG criteria. Patients who have an     abnormal result from the 'rule-out criteria' will be referred for transthoracic     echocardiography. All echocardiograms will be performed according to a predefined     standardized protocol.      In case of echocardiographic intermediate or high probability of PH, patients will be     referred for further diagnostic work-up of suspected CTEPH starting with perfusion lung scan     or VQ-scan and right heart catheterization, of which the results will be discussed by an     independent interdisciplinary working group of PH specialists, to ensure optimal diagnostic     management. This latter diagnostic work-up of an abnormal echocardiograph lies within the     setting of standard medical care.      All patients who were not diagnosed with pulmonary hypertension of any origin, or with NYHA     class III or IV heart failure due to left ventricular systolic dysfunction, left ventricular     diastolic dysfunction or significant valvular lesions, will be followed for a total of 2     years from the index PE diagnosis. During that period, the study protocol will not interfere     with standard patient care, allowing diagnostic tests as deemed indicated by the treating     physician including echocardiography in case of new respiratory symptoms. At the end of the     follow-up period, all patients will be subjected to a second echocardiography that will be     handled according to the above stated procedures to evaluate the presence of CTEPH.   "
55809|NCT02555124|"     The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral     administration.   "
55810|NCT02555111|"     Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the     recurrence of thromboembolic event compared to an untreated group in patients with chronic     portal vein thrombosis without high risk thrombophilia.   "
55811|NCT02554058|"     A novel rehabilitation bike has been developed for patients with incomplete spinal cord     injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory     receptors in the soles of the feet; the effect of mechanical stimulator on muscle     strengthening has been reported by NASA to improve muscle atrophy in astronauts in     zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict     that the combination of mechanical stimulation with cycling may be similar enough to walking     over ground to lead to gains in balance and mobility. The present study will evaluate the     therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal     pathways in patients with incomplete spinal cord injuries.   "
55812|NCT02555085|"     The primary objective of the study is to evaluate the safety and tolerability of single     ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy     volunteers. The secondary objectives of the study are to estimate the PK parameters of single     ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F)     of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses     of BIIB063.   "
55813|NCT02555072|"     This is a Phase IV study cohort, uncontrolled, composed of two segments: children and healthy     adults. It will be included 2756 children and 2005 adults, evaluated initially in six     different times (before vaccination, 30-45 days, 1 year, 4 years, 7 years and 10 years after     vaccination). The Paraiba state was selected for the study because in this region there are     no yellow fever virus dissemination and therefore no NIP recommendation for people's routine     vaccination. However, the NIP indicate yellow fever vaccination for individuals who are     moving to areas with virus circulation. The study will take place in six (6) Basic Health     Units of three (3) municipalities (2 units per municipality) in the state of Paraíba. The     selected municipalities are: Alhambra, Caaporã and Conde. The study target population     consisted of healthy children and adults of both sexes. Children must be between 9 months and     4 years,11months and 29 days; adults between 18 and 50 years. It will be eligible for the     study, people who have never received the yellow fever vaccine checked in vaccine design and     history and who agree to participate. Not be included participants with any contraindication     to vaccination against yellow fever and individuals who previously moved to risk areas for     extended periods. The study main objective is to assess the immune status of children and     adults who have never vaccinated, they will receive the first dose of 17DD yellow fever     vaccine provided by the study and will be monitored for 10 years. Depending on the results of     the analyzed of the data, the period of monitoring may be extended.   "
55814|NCT02555059|"     The objective in this study is collecting post-marketing information on the safety and     efficacy of Ciproxan injection under the routine clinical practice.   "
55815|NCT02555046|"     The purpose of this study is to determine the effect of General versus Local Anaesthesia on     muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised     controlled trail.   "
55816|NCT02555033|"     Aging results in a gradual decline of physical abilities and consequently in functional     impairments which increases the risk of falls in elderly people. It has been shown, that     balance and resistance training can counteract the effects of aging. The aim of this study     was to investigate effects of instability resistance training (IRT), combining balance and     resistance training, on measures of muscle strength / power and balance for falls in healthy     community-dwelling older adults. Therefore 75 elderly people, aged 65 - 80 years (Mage =     70.4; SD = 4.3 years) were assigned into three intervention groups: machine-based (M-RT),     machine-based instability (M-IRT), free weight instability resistance training (F-IRT). All     three groups exercised over 10-weeks with two training sessions per week. Assessment of     muscle strength (e.g. maximal isometric leg extension strength), power (e.g. chair rise test)     and balance (e.g. gait, functional reach test) was conducted before and after training.      Based on the principle of training specificity, it is assumed, that groups to improve better     within their respective training modality. Thus, the investigators hypothesis that regarding     measures of strength and power, M-RT performs better than M-IRT, performs better than F-IRT.     As to measures of balance, we hypothesis that F-IRT performs better that M-IRT, performs     better than M-RT.   "
55827|NCT02554890|"     The purpose of this study is to assess the effect of in-hospital initiation of     sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP     in patients who have been stabilized following hospitalization for acute decompensated heart     failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤     40%).   "
55828|NCT02554877|"     The purpose of this study is to determine whether PF-06291874 is effective in the treatment     T2DM   "
55817|NCT02555020|"     Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative     carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery     (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been     widely investigated and have been shown to be associated with improved postoperative     outcomes, some individual constituents of these protocols, including preoperative     carbohydrate treatment, have not been subject to such robust analysis.To assess the effects     of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on     postoperative recovery and insulin resistance in adult patients undergoing elective surgery.   "
55818|NCT02555007|"     Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant     Pleural Mesothelioma, but all the studies published thus far were based upon a variety of     empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modeling     showed by simulation that a new metronomic protocol could lead to a better safety and     efficacy profile.      Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate     efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic     NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and     an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an     alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical Protocol)     with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is two-staged as     12 patients are planned to participate in the phase Ia, to confirm safety and consolidate the     calibration of the average parameters of the model. Depending the phase Ia result, and after     favorable decision of a consultative committee, the extension phase (phase Ib) will be an     efficacy study and will include a number of 20 patients receiving the Optimal Vinorelbine     Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the     phase Ia and the objective response according to RECIST 1.1 for the phase Ib.      An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.      Discussion: this ongoing trial is the first to prospectively test a mathematical optimized     schedule in metronomic chemotherapy. As such, this trial can be considered as a     proof-of-concept study demonstrating the feasibility to run a computational-driven protocol     to ensure an optimal efficacy/toxicity balance in patients with cancer.   "
55819|NCT02554994|"     Frailty is a highly prevalent, progressive condition in older adults that is characterized by     multisystem physiologic impairments and vulnerability to stressful events, leading to     increased risk of geriatric conditions, disability, falls, hospitalization, and mortality. An     effective public health intervention to improve frailty in a rural aging population with     limited resources remains unknown. The purpose of our study is to evaluate the effectiveness     of multidimensional public health intervention to reduce frailty and related geriatric     conditions in older adults in rural communities. Our hypotheses are that a multidimensional     intervention consisting of group exercise, nutritional support, depression management,     polypharmacy, and home safety intervention over a 6-month period will improve frailty and     selected geriatric conditions in older adults who are in low socioeconomic status or living     alone in a rural community. Our primary outcome is short physical performance battery at 6     month. Secondary outcomes include frailty status, nutritional status, depression, falls,     sarcopenia, and health care utilization. The investigators will conduct a designed delay     trial by implementing our intervention in one town for the first 6 months (intervention     group), while measuring the outcomes without any intervention in another town (serving as a     control group); in the following 6 months, the investigators will implement the 6-month     intervention in the control town. The findings from our study will inform us to find     effective public health interventions to promote healthy aging in resource-limited, rural     populations.   "
55820|NCT02554981|"     This study will evaluate the efficacy of Restasis® in participants with dry eye disease who     engage in electronic visual tasking.   "
55821|NCT02554968|"     This study will utilize Rasch analysis to study the construct validity and reliability of     five shoulder-related patient-reported outcome measures in patients reporting shoulder     impairment following surgery for head and neck cancer.   "
55822|NCT02554955|"     This study will evaluate the efficacy and safety of intravenous daclizumab in combination     with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart     transplant, and at risk of impaired kidney function. The anticipated time on study treatment     is 6 months, and the target sample size is 44 individuals.   "
55823|NCT02554942|"     This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults     with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia.     The anticipated time on study treatment is 16 weeks, and the target sample size is     approximately 208 individuals.   "
55824|NCT02554929|"     This study is to assess the efficacy of a brief, 11-week, manualized Taming Sneaky Fears for     Social Anxiety Disorder (SAD) and/or Selective Mutism (SM) child and parent group Cognitive     Behavioural Therapy (CBT) treatment protocol. Children 4 to 7 years old (n = 88) meeting     criteria for SAD and/or SM, and their parents are recruited from the Psychiatry Outpatient     Program and participants will be randomized to either the Taming Sneaky Fears group or a     parent psycho-education and child socialization group. Trained clinicians blinded to all     measures and treatment assignment will administer pre, post and 6-month follow-up outcome     measures. Investigators assess within-the-child and within-the-parent/environment factors     that predict treatment outcomes.   "
55825|NCT02554916|"     This is an exploratory study designed to investigate the effects of aerobic dual belt     treadmill walking versus traditional treadmill exercise on gait performance and functional     capacity in older adults at risk for mobility disability. Identifying the relationship     between aerobic treadmill exercise (dual belt or traditional) and the recovery of walking     abilities will serve to optimize current rehabilitation approaches.   "
55826|NCT02554903|"     STUDY OBJECTIVES Primary objective(s) To evaluate the effect of macitentan 10 mg on pulmonary     vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH)     after left ventricular assist device (LVAD) implantation.      Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on     cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD     implantation.      To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD     implantation.      Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to     placebo on right ventricular function in subjects with PH after LVAD implantation.      To explore the potential effect of macitentan 10 mg as compared to placebo on selected     clinical events in subjects with PH after LVAD implantation.      To explore the potential effect of macitentan 10 mg as compared to placebo on renal function     as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.   "
55841|NCT02554708|"     To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.   "
55830|NCT02554851|"     Phase III clinical trial, multicenter, controlled, randomized, double-blind, with two     parallel groups (experimental and control). Both study groups will receive standard therapy     currently available in treatment centers for diabetic foot ulcer (DFU). Associate with the     standard therapy, it will be given the recombinant human Epidermal Growth Factor (rhEGF) to     experimental group and in the control group, it will be given a formulation without     pharmacological effect (placebo) in order to masking and control of intralesional     application. Participants with type 1 and type 2 diabetes mellitus (DM) diagnosed with DFU     for at least 4 weeks, treated in referral centers participating in the study, agreeing to     participate after reading, understanding and signing of Informed Consent (IC); meet all the     inclusion criteria; and presenting no exclusion criteria. The Informed Consent (IC) should be     applied to potential participants, as recommended by the regulations and ethical consensus     before beginning any procedure related to the clinical trial. In the early weeks,     participants will be evaluated at the research centers by the study team (doctors and / or     staff). The number of visits will be determined by the investigator, thus ensuring     appropriate assistance to participants, and avoiding any complications with DFU. By meeting     the eligibility requirements (inclusion and exclusion criteria), the participant will undergo     a thorough evaluation of the DFU before the start of treatment. This assessment is precisely     to classify the condition of the ulcer before treatment and provide relevant information for     statistical analysis of the protocol. If eligible, the participant will be randomly set to     treatment arm (placebo or rhEGF) and the administration of investigational product associated     with predefined standardized outpatient therapy will be initiated. This administration occurs     three times per week until the DFU is scarred, not exceeding 8 weeks of treatment (T.01 to     T.08) .The study will be randomized and balanced according to the type and size of the DFU.     This balancing is necessary to ensure that both treatment groups are homogeneous for     participants under different conditions. All participants will be applied established     standard therapy for the treatment of DFU. The objective is to provide regular care for     healing and reduce possible bias in the efficacy analysis and product safety. After the     treatment period (last dose of the experimental drug) the participant will start the     follow-up period, with 16 weeks duration. The participant shall be subjected to weekly visits     for ongoing assessment of DFU, however, according to the investigator, may result in     unscheduled visits to assess local or general clinical events. After the monitoring period,     the participant will be observed for 24 additional weeks, visits every 4 weeks (E.01 E.24 a)     having beginning one week after the last visit of follow-up. This period is intended to     assess possible events related to the efficacy and safety that can happen in the period,     mainly for analysis of secondary endpoints.   "
55831|NCT02554838|"     This project aims to determine the respective impacts of two routine care regarding phobic of     falling seniors on the mobility restriction. The investigators used a monocentric, randomized     and controlled research according to two parallel groups : physical activity, home assessment     and modification (rehabilitation group) versus physical activity, home assessment and     modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT group). The     investigators will assess the efficacy of usual care (rehabilitation group) and the     supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space Assessment.   "
55832|NCT02554825|"     This study evaluated the impact of the three-year Healthy Futures program on teen sexual     behaviors in three Massachusetts cities.   "
55833|NCT02554812|"     This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics,     pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination     with other cancer immunotherapies in patients with locally advanced or metastatic solid     tumors. The primary purpose is to assess the safety and early signs of efficacy of various     avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as     appropriate, in a limited series of indications.   "
55834|NCT02554799|"     This study will be conducted in a single centre, as an open single dose two parallel cohorts     design with oral doses of MMV390048 administered in healthy male and female subjects between     18 to 55 years of age. Subjects will be screened within 28 days prior to entering the study.     On Day 1 of the study each subject will receive one of the two MMV390048 prototype     formulations, at a dose of 40 mg with 240 mL of water. Subjects will be discharged on Day 3     after 48h post-dose and they will attend the unit for follow-up visits on Days 5, 7, 10, 14,     19, 26 and 29.   "
55835|NCT02554786|"     The purpose of the trial is to evaluate the efficacy and safety of two different doses of     QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses     (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic     patients as determined by pulmonary function testing, and effects on asthma control   "
55836|NCT02554773|"     The purpose of this study is to evaluate the long-term safety and tolerability of ALN-AT3SC     in male patients with moderate or severe hemophilia A or B.   "
55837|NCT02554760|"     Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the     flank using an applicator with the Crown Cooling Insert.   "
55838|NCT02554747|"     Diabetic macular edema (DME) in diabetic retinopathy (DR) is the leading cause of visual     impairment among the 300,000 Danish patients with diabetes (DM) and will in time affect 29%     of patients. Because of DME, 550 intravitreal injections were given at Odense University     Hospital in 2014 with medicine expenses approximating 3.3 million DKK. With an increasing     prevalence of diabetes, the number is expected to rise significantly for the years to come.      The investigators hypothesize that combination therapy with intravitreal aflibercept and a     new computer navigated photocoagulations system (Navilas®) leads to a decreased need for     intravitreal injections.      Further, the investigators wish to identify retinal risk markers for DME treatment outcome to     assist individualized treatment planning. The evaluation of the baseline level of macular     ischemia as marker of successful treatment outcome is of particular interest as this is still     highly debatable and may prove a significant prognostic factor of anatomical and functional     outcome to anti-VEGF treatment.      The ADDENDUM study (four-year part-time PhD study) is a 12-month prospective randomized 1:1     study to compare intravitreal aflibercept and Navilas® laser (Group A) with intravitreal     aflibercept and conventional Pascal laser (Group B) in the treatment of DME.      Eligibility criteria: DM, age 18-99, clinically significant macular edema, central retinal     thickness > 300 μm, best corrected visual acuity 35-75 Early Treatment Diabetic Retinopathy     Study (ETDRS) letters.      The investigators believe that this study holds the potential to set precedent for a new gold     standard of DME-treatment with increased treatment effect, reduced risks and a more     cost-effective approach.   "
55839|NCT02554734|"     Phase I open, randomized cross-over pharmacokinetic study.   "
55840|NCT02554721|"     The primary objective of this study is to investigate the effects of Cilostazol,     Acetylsalycylic acid and Clopidogrel alone as well as combinations of     Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF)     testing.   "
55886|NCT02554123|"     A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s     haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be     performed. The patients will be randomized into 2 groups:        -  Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application          of Vitamin E ointment on the surgical bed.        -  Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of          Vaseline on the surgical bed.      Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for     morphine rescue will be investigated.   "
55844|NCT02554669|"     Physical activity performed in the postprandial state has the ability to blunt postprandial     glycemia acutely, even as a result of very light or small amounts of postprandial physical     activity. Postprandial physical activity decreases postprandial glycemia more effectively     than activity performed in the post-absorptive state. However, studies comparing postprandial     and postabsorptive physical activity have measured glycemic outcomes in only short periods of     time (hours) or have used a very large dose of physical activity.      Physical activity have the ability to entail an acute increase in markers of systemic     inflammation.Previous studies has also shown that systemic inflammation is increased during     glycemic spikes, such as after a high carbohydrate load. Therefore the effect of postprandial     physical activity is difficult to predict. One one hand it might increase markers of systemic     inflammation. On the other hand it might decrease systemic inflammation as a result of a     blunting effect on postprandial glycemia. The effect of physical activity after carbohydrate     intake might therefore also differ from postabsorptive physical activity.      Purpose of the study: I) The investigators hypothesized that light physical activity     performed in the post-prandial sate decrease blood glucose in a day and night cycle compared     to the same activity performed in the postabsorptive state and a control day. II) To test     whether postabsorptive and postprandial light physical activity do affect markers of systemic     inflammation different.      12 participants diagnosed with hyperglycemia but not on hypoglycemic medication took part in     a randomized cross-over trial with 3 test days. A control day with no physical activity, and     two days similar to the control day except that one of them contained a one hour bout of     treadmill walking prior to breakfast and the other a similar exercise bout after breakfast.     Continuous glucose monitoring was performed from start of exercise / breakfast until the     morning next day (at least 22 hours). Venous blood was also sampled at given timepoints     (before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast. Dietary     intake was individually standardized prior to and during test days.   "
55845|NCT02554656|"     Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general     clinical practices.   "
55846|NCT02554643|"     The present study aims to evaluate the impact of a soccer training program lasting 12 weeks     in patients with type 2 diabetes mellitus. 60 sedentary adults and elderly patients with type     2 diabetes mellitus (age: 50-75 y), with a BMI > 25kg/m2 and > 29kg/m2, respectively, from     the Hospital of the Medical Faculty of São Paulo University will participate in this study.     They will be randomly divided in 3 groups (soccer, running and control). All patients will     undergo the following assessments: anthropometric, dietary, physical performance,     inflammatory, metabolic and hormonal parameters such as gene expression, bone markers and     predictors of cardiovascular disease. In addition the investigators aim to evaluate the body     composition of these patients by DXA, and muscle and visceral lipids content by proton     spectroscopic MRI.   "
55847|NCT02554630|"     Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of     mortality is in preterm neonates, especially low birth weight (LBW), and very low birth     weight (VLBW) neonates. The estimated cost of caring for these patients is approximately $700     million in the US alone.      In an effort to help mature the neonatal immune system, several adjuvant therapies have been     studied; however, none have been implemented in clinical practice. One of the most frequently     considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs detect conserved     molecular products of microorganisms (lipopolysaccharide (LPS), and initiate immunity and     inflammation. Early adjuvant administration in VLBW infants may be a viable approach to     reducing the incidence of early and late sepsis.      This research study will characterize immune genomic expression and functional capacity at     the time of birth in both term and preterm neonates and determine what effects, if any, that     adjuvants have on this function. Additionally, this study will seek to determine if immune     function correlates with certain microbiota.   "
55848|NCT02554617|"     The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in     healthy subjects among Thai populations.   "
55849|NCT02554604|"     The study is design to assess if there is a correlation between diagnosis of preeclampsia and     its severity to changes in HDL quality, in terms of composition and function and to determine     whether preeclampsia-induced changes in VOCs in saliva can be used for the early diagnosis of     preeclampsia.   "
55850|NCT02554591|"     The investigators propose to conduct a retrospective study of single agent ceritinib in     patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged adenocarcinoma     of the lung with the sole purpose of characterizing the genomic landscape before ceritinib     and at the time of disease progression.   "
55851|NCT02554578|"     The purpose of this study is to improve medication adherence, engagement and support to heart     transplant patients through implementation of a new clinical care programme conducted by the     clinical pharmacy service in cooperation with the heart transplant team and supported by     mobile health (mHealth).   "
55852|NCT02554565|"     Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients     with cervical cancer compared to the early detection of minimal metastatic disease.   "
55853|NCT02554552|"     This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa     clinical trial of YY1201 for treatment of osteoarthritis of the knee.   "
55854|NCT02554539|"     The purpose of this study is to understand the mechanism of communication between the uterine     environment and the preimplantation human embryo. The investigators are interested in     understanding how the in-utero environment during the window of implantation is different in     normal weight and overweight/obese women and how this may impact the programming of the     developing embryo.   "
55855|NCT02554526|"     Using whole blood samples and plasma samples obtained from some hemophilia A patients with     inhibitors, the investigators will perform the coagulation assessment in the co-presence of     aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under     blood flow conditions.   "
55856|NCT02554513|"     The purpose of the proposed research is to examine the effects of two treatment approaches on     speech production involving speakers with chronic apraxia of speech (AOS) and aphasia. The     planned investigation is designed to examine the acquisition, maintenance and generalization     effects of each treatment. One approach, electropalatography (EPG) uses visual biofeedback in     conjunction with articulatory-kinematic treatment and the other approach, sound production     treatment (SPT) is one of the most systematically studied articulatory-kinematic treatments     for AOS.   "
55857|NCT02554500|"     In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at     replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although     previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate bone     healing in case of non-union, only a few studies focused on the elucidation of its mechanisms     of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of     remote ischemic preconditioning (RIPC) on scaphoid bones and metacarpal bones and metatarsal     bones in a human in-vivo setting for the first time.   "
56221|NCT02549742|"     A phase II clinical trial testing electrochemotherapy on mucosal recurrent head and neck     cancer. Twenty-five patients will be treated. Primary outcome is tumour response on imaging.     Secondary outcomes are response from tissue samples, VAS score, Quality of life evaluation     and side effects to treatment.   "
55858|NCT02554487|"     Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major     importance. First because of the high occurrence rate of stroke and the fact that it is a     frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central     and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on     clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated     neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation.     Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive     Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and     mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on     clinical stroke outcome.      To this end, the investigators recruit and prospectively follow 3 groups of patients with     ischemic stroke over 1 year. During the first night after hospital admission due to acute     stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with     significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are     randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts     the second night following hospital admission and ends 90 days later. Stroke patients without     SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion     volume and stroke outcome without the additional burden of SDB.      Lesion volume one day after hospital admission due to acute stroke (after potential lysis     therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume     measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared     between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients     without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical     scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive     outcome is assessed during hospitalization (within the first week following stroke) and after     the treatment period of 90 days by neuropsychological tests assessing attention and memory.     In addition, baseline assessment of physiological parameters such as blood pressure and     endothelial function/arterial stiffness are assessed during the first weeks following stroke     and at the end of the treatment period, i.e. approximately 90 days following stroke.   "
55859|NCT02554474|"     Being physically active can reduce pain and fatigue, improve mobility and enhance quality of     life in people with arthritis, but adherence to an active lifestyle is poor, with less than     half of people with arthritis being active. The primary goal of this randomized controlled     trial is to assess the efficacy of a physical activity coaching model to improve physical     activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and     Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless physical     activity tracker) paired with a FitViz application, a group education session, and telephone     counselling by a physiotherapist.   "
55860|NCT02554461|"     On the basis of clinical and movement analysis records players are informed on what     parameters can be optimized in order to improve their performance and avoid injuries   "
55861|NCT02554448|"     The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in     peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox     treatment and chemoradiotherapy,before and after surgery.   "
55862|NCT02554435|"     Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to     physical activity. Most older adults do not participate in healthy levels of physical     activity. Physical activity promotion and counseling from a primary health care provider is     important for disease prevention. In addition to counseling, an activity monitor can increase     physical activity through self-regulation. Two types of monitors are available: pedometers     and electronic activity monitors (EAMs). Research shows that both monitors are motivational     devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can     monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also     offer more behavioral change techniques and opportunities for self-monitoring. The goal of     this study is to compare the effectiveness of EAMs compared to a pedometer on increasing     physical activity and decreasing cardiovascular risk within older adult, primary care     patients. The study will include sedentary, overweight primary care patients, 55-74 years of     age with access to a smart phone or tablet. All participants will receive brief physical     activity counseling. Participants will then be randomized to receive a self-monitoring device     (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate     the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator,     fitness), psychological feeling toward exercise, physical function, health status, exercise     motivation and self-regulation. The investigators hypothesize that EAMs will be more     effective than pedometers in improving these outcomes. The results of this pilot test will     aid in the translation of effective physical activity intervention components to primary care     clinics for cardiovascular disease prevention.   "
55863|NCT02554422|"     Feasibility of the objective measurement of the ossicular chain mobility, by using a     force-measuring device based on a fiber optics sensors (PalpEar).   "
55864|NCT02554409|"     The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy     Registry will be a prospectively recruited pregnancy surveillance program designed to collect     to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and     offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.   "
55865|NCT02554396|"     This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and     safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1,     PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects     on improving near-vision acuity.   "
55866|NCT02554383|"     The objective of this trial is to determine whether certain subgroups of children with acute     sinusitis exist in whom antibiotic therapy can be appropriately withheld.   "
55867|NCT02554370|"     Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to     improve motor signs and reduce dopaminergic treatment and related motor complications in     patients with severe forms of Parkinson's disease (PD). However, psychological disorders and     socio-familial maladjustment are less clearly improved with subthalamic stimulation with an     aggravation of the social adjustment described in about 1/3 of cases, with work disruption,     divorce or familial conflict. The caregivers have also been reported to present negative     well-being after surgery with an aggravation of the quality of life. In the present study,     the investigators evaluate the effects of a perioperative psychoeducational programme to     avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic     stimulation, and their caregivers, in a randomized controlled study.   "
55868|NCT02554357|"     Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single     injection nerve blocks.   "
55869|NCT02554344|"     The purpose of this study is to determine the safety, feasibility, and regression rate of     using curcumin in patients with Cervical Intraepithelial neoplasias (CIN3). The secondary     objectives of this study is to evaluate patients with CIN3 for the presence of high-risk     Human papillomavirus (HPV) and to perform an inflammatory panel on dysplasia biopsies from     patients with CIN3 to determine which factors play a role in persistence of CIN3.   "
55882|NCT02554175|"     The aim of this study was to determine the target propofol concentration needed to provide     adequate hypnosis for induction and tracheal intubation for Schnider model using total body     weight (TBW) in parturients. In addition, investigators wanted to define the hemodynamic     adverse effects associated with these propofol target concentrations.   "
55883|NCT02554162|"     This study examines if there are differences in satiety responses between structurally     different wholegrain rye products.   "
55884|NCT02554149|"     The purpose of this study was to develop a radiological method to measure stem anteversion     and to determine its validity and reliability.   "
55870|NCT02554331|"     Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an     underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy     body disease. Identifying additional abnormal clinical features may help in identifying those     at greater risk of evolving to a more severe syndrome. Because gait disorders are common in     the synucleinopathies, early abnormalities in gait in those with RBD could help in     identifying those at increased risk of developing overt parkinsonism and/or cognitive     impairment.      The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify     sensitive and early biomarkers:        1. to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and        2. to track their evolution in the parallel with the disease progression.      Main objective: In comparison with age and gender matched-controls, to identify in patients     with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal     characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).      Secondary objective:        1. In comparison with age and gender matched-PD patients, to identify in patients with RBD          a smaller reduction of gait velocity (and other abnormalities of spatio-temporal          characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).        2. In patients with RBD to identify correlations between the spatio-temporal          characteristics modifications of gait between a single (gait) and a dual-task          (gait+cognitive task) and the percentage of REM without atonia - the dopamine          transporter (DAT) density using FP-CIT single-photon emission computed tomography; the          reduction of the olfactory discrimination and thresholds.        3. In patients with RBD to track the spatio-temporal characteristics evolution of gait over          time (every 6 months for 2 years)   "
55871|NCT02554318|"     Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting.     Wasting reduces lean body mass and may cause physical function impairment. This study aimed     to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight     and physical function changes among active pulmonary tuberculosis patients with standard     therapy.   "
55872|NCT02554305|"     This study compares between the clinical, hematological, inflammatory and neurological     outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which     different oxygenation systems will be used.   "
55873|NCT02554292|"     The main objective of the SeQuent® Please Neo post market surveillance is to assess the     clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon     before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world'     setting for the treatment of in-stent restenosis.   "
55874|NCT02554279|"     The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant     Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in     women undergoing controlled ovarian stimulation (COS) following GnRH treatment.   "
55875|NCT02554266|"     The study will enroll patients presenting with claudication, or critical limb ischemia     (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion     appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix     Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a     minimum of 2 years.   "
55876|NCT02554253|"     Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia     as well as as an analgesic. It has been shown to have anti-inflammatory properties which may     decrease post-operative complications following cardiac surgery with cardiopulmonary bypass     that are thought to associated with inflammation. Some studies have shown that ketamine does     decrease these complications when compared with anesthetics that are not commonly used in our     cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication     which is used for induction of anesthesia. Ketamine has not been compared with propofol for     potential to reduce post-operative complications associated with the inflammatory process.     This study aims to see if ketamine will reduce the incidence of cognitive dysfunction,     delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic     impact of ketamine compared propofol will be investigated.   "
55877|NCT02554240|"     This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients     with osteoarthritis of the knee.   "
55878|NCT02554227|"     Spondylodiscitis is an infectious disease of the intervertebral discs and adjacent vertebral     bodies, which often has a protracted progression. Diagnosis is frequently delayed because of     the unspecific pathology and a lack of specific infection markers. However, an early     diagnosis is fundamental to prevent long periods with symptoms including extensive back pain     and progressive and destructive changes of the spine.      Cytokines can be helpful to extend the knowledge about diverse biological processes.     Furthermore, they are a promising category of biomarkers that are already present in the     early phases of developing diseases. Currently, little is known about the participation of     cytokines in Spondylodiscitis. The aim of this study is to establish a non-invasive method to     improve the diagnosis of spondylodiscitis. Therefore, blood and tissue samples will be     analyzed at different time points for the concentration of specific cytokines to select     potential marker cytokines via a Multiplex Assay. After successful identification of marker     cytokines, verification of the results will be done by expression analysis of     cytokine-producing cells.      The potential of such a diagnostic method lies in reducing medical costs and preventing     extensive pain and structural changes of the spine.      Experimental research will be performed with the approval of the ethic committee of the     medical faculty of the University of Cologne.   "
55879|NCT02554214|"     This will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30     patients who satisfy entry criteria is estimated to be appropriate to provide safety and     performance data for this study.      The objectives of the study are to verify the performance and safety of the Glafkos     adjustable glaucoma drainage device system. Performance will be measured assessing the     possibility to adjust the intra-ocular pressure post-operatively. Safety will be measured by     the incidence and severity of adverse events.      The Glafkos device will be implanted in combination with a seton tube. The implant is placed     under a scleral flap, in a manner analogous to the ex-Press device (Alcon). The distal end of     the draining tube is linked to a seton draining tube, which is linked to a plate placed under     the extraocular muscles, creating a filtering space at the orbit (filtering bleb).   "
55880|NCT02554201|"     The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent     from late complications. The present study is to evaluate the efficacy of electrical pudendal     nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The     study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible     patients will be involved and divided into EPNS or TES group according to their location of     medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS).     The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine     volume.   "
55881|NCT02554188|"     The objective of this study is to test a Fasting-Mimicking Diet (FMD) for its efficacy on     improving immune response to flu vaccination in an older adult population (50-75 years of     age).   "
55888|NCT02554097|"     Patients with gallstone and confirmed common bile duct stones are registered in this study.     The three managements for common bile duct stones are endoscopic sphincterotomy (EST),     laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile     duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative     investigations, operative method, operative time, conversion to open procedure,     intraoperative and postoperative complications, and the presence of retained and recurrent     stones. All patients were followed up for 3 years by telephone interview ang outpatient     visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom     appeared during the follow-up period. If there were unusual findings, magnetic resonance     cholangiopancreatography(MRCP) was carried out.   "
55889|NCT02554084|"     The purpose of this study is to evaluate a new instrument that takes digital images of tear     film (a thin film that coats the eye that is made up of oil and water). The investigators are     interested in measuring how the thickness of the tear film varies through time. The goal is     to develop a technique that may enable non-invasive evaluation of Dry Eye Disease for future     clinical diagnosis.   "
55890|NCT02554071|"     A single arm pilot study conducted to assess the feasibility of having Manitoba Pharmacists     provide support (product and cognitive) to low-income (receiving social assistance) smokers     wishing to quit smoking.   "
55891|NCT02554045|"     Data confirming a role for PDE5 in adipocyte biology in vitro have been recently reported.     However, a better understanding of the complex role of PDE5 in fat metabolism and whole body     homeostasis requires the use of transgenic animal models either lacking or overexpressing     PDE5 in adipose tissue. This will clarify the role of PDE5 in adipose expansion and     metabolism, and also in glucose homeostasis and vascular function in vivo. Analysis of     expression and activity of PDE5 in different sites of human adipose tissue (i.e. visceral vs.     subcutaneous), and also in different metabolic conditions (i.e. high-fat diet vs. low calorie     intake) could reveal if PDE5 can be considered to be a reliable 'marker' of metabolic     dysfunction of the adipocyte. Importantly, chronic treatment with the PDE5 inhibitor     sildenafil in a mouse model of diet-induced insulin resistance caused a significant     improvement in insulin sensitivity . Also, in humans chronic exposure to tadalafil confirmed     an improvement of insulin sensitivity in men with erectile dysfunction. However, the efficacy     of long-term treatment with PDE5i awaits demonstration in human metabolic diseases such as     obesity and insulin resistance.      The primary purpose of the study is to investigate the effects of tadalafil taken once a day     on body composition in men with sexual distress and/or erectile dysfunction.   "
55892|NCT02554032|"     The ACE trial is a multicentre, randomized controlled trial comparing axillary vs. innominate     artery cannulation for established antegrade cerebral perfusion in patients having aortic     surgery (thoracic and aortic arch) requiring deep hypothermic circulatory arrest using a     non-inferiority trial design.   "
55893|NCT02554019|"     The purpose of this study is to evaluate the safety and efficacy of repeated intravenous     infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE)     compared with people who receive a placebo.   "
55894|NCT02554006|"     A single-center, randomized trial of admitted patients with ischemic heart disease receiving     percutaneous coronary intervention and stent implantation will be conducted at University     Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the     bundle group in which patients will receive counseling regarding dual antiplatelet therapy     management, advantages and side effects, screening for depression or anxiety, standardized     education. The primary endpoint will be the difference in the quality of life as assessed by     EQ-5D questionnaire.   "
55895|NCT02553993|"     The objective of this study was to: compare the training and maintenance effects of 3 balance     training programs (2 kinds of exergame systems and 1 conventional weight-shifting training     program) on cognitive function of subjects with chronic stroke.   "
55896|NCT02553980|"     Practicing a habitual physical activity is important for health. A Virtual Trainer (VT)     online system was developed in 2006 (1st version) and improved in 2010 (2nd version) for     encouraging an active lifestyle. This project intends to further improve the VT (3rd version)     which incorporates more effective psychological and e-health theories, and disseminate it to     Hong Kong middle-aged adults.   "
55897|NCT02553967|"     Breast reconstruction is an integral part of the management of patients with breast cancer     and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying     aesthetic and functional result (sensitivity) and that would enable the patient to     appropriate the reconstructed breast. Patient satisfaction assessed subjectively by     questionnaires would be better in autologous reconstructions than in reconstructions by     prosthesis.      The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to     describe the brain functional changes of sensory projections after immediate or secondary     breast reconstruction.   "
55913|NCT02553759|"     The aim of the present protocol is to prove if the observed actions (AOb) will improve the     cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This     study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and     pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will     consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second     measurement (motor imagery).   "
56222|NCT02549729|"     The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on     muscle function of postmenopausal women using or not using hormonal therapy replacement     (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its     severity and impact on quality of life.   "
55914|NCT02553746|"     The patients will be allocated to 2 groups: the ultrasound group and the palpation group.     Ultrasound detection of the puncture site will be performed to the patients of the one group     (group U). The puncture site will be determined by palpation of the landmarks at the patients     of the other group (group L). The main purpose of the study is to determine if the ultrasound     scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural     anesthesia, increase the success and decrease the complication rate of these techniques. The     secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to     determine accurately the depth of the epidural space.   "
68833|NCT02384811|"     The primary object of this trial is to evaluate the 2-year local control rate adding     extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell     carcinoma.   "
55898|NCT02553954|"     Epidemiological data show that the incidence of carcinoma, the most common cancer, is     strongly linked to the age. Non Melanoma Skin Carcinomas (NMSCs) (the most frequent cancers     in the elderly population) derive from keratinocytes of the basal layer of the epidermis,     from differentiated keratinocytes of the more superficial layers or from stem cells of hair     follicles. Unlike NMSCs, soft-tissue sarcomas, including those deriving from dermal     fibroblasts, are very rare (less than 1% of all cancers). Our overall purpose is to decipher     the molecular pathways activated during the aging of these tissues that may explain why they     have a so different propensity to undergo a malignant transformation. Given that senescent     cells accumulate in the dermis and epidermis with age, we will constitute two groups : young     skin that we arbitrarily limit to the range ≥ 18 and ≤ 40 and aged skin ≥ 55.      Thus the main objective of our study is to search within 2 age groups (≥ 18 and ≤ 40 years     and ≥ 55 years) the expression of senescence markers on healthy skin tissue.   "
55899|NCT02553941|"     This phase Ib trial studies the side effects and best dose of ibrutinib when given together     with azacitidine in treating patients with myelodysplastic syndrome that is likely to occur     or spread (higher risk) and who were previously treated or untreated and unfit for or refused     intense therapy. Ibrutinib and azacitidine may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.   "
55900|NCT02553928|"     Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared     with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range     5-18.   "
55901|NCT02553915|"     This project aims to evaluate whether a dose-response relationship exists between dose of     polyunsaturated fatty acids (PUFA), delivered as eicosapentaenoic acid (EPA), and change in     markers of inflammation, and whether these effects differ from placebo. A key secondary aim     is to evaluate the antidepressant effectiveness of EPA in overweight adult outpatients with     current major depressive disorder (MDD). To address these aims, the project will use a     four-arm, randomized, parallel-group, placebo-controlled design comparing placebo versus     three doses of EPA (1 gm/day, 2 gm/day, or 4 gm/day) administered over 12 weeks. The study is     to be conducted at two sites: Emory University School of Medicine, and Massachusetts General     Hospital. Eligible participants will be between the ages of 18-80 who have current MDD, are     overweight, and who demonstrate peripheral inflammation, defined as an high sensitivity     C-reactive protein (hs-CRP) level ≥ 3 mg/L. The primary outcome will be change in plasma     interleukin-6 (IL-6) levels and/or mitogen-stimulated peripheral blood mononuclear cells     (PBMC) Tumor Necrosis Factor-alpha (TNF-α) expression levels in EPA- versus placebo-treated     participants. The results of this investigation are intended to be used to design and power a     larger definitive test of the efficacy and biological effects of EPA in patients with major     depressive disorder.   "
55902|NCT02553902|"     OBJECTIVES:      To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with     continuous positive airway pressure (CPAP) in patients with moderate positional obstructive     sleep apnea (POSA).      HYPOTHESIS:      The SPT+MAD combination is more cost-effective and effective, in means of reduction of the     apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.      STUDY DESIGN:      A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months     per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All     outcomes will be measured at baseline, month 3, 6 and 12.      STUDY POPULATION:      Patients diagnosed with moderate POSA according to polysomnography (PSG) results.      INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:      The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway     pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a     protrusive position, all to prevent effectively apneic events.      OUTCOME MEASURES:      AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular     parameters, incremental cost-effectiveness ratio (ICER)      SAMPLE SIZE / DATA ANALYSIS:      100 subjects in each treatment group, total of 200 patients.      COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:      The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients,     and will save annually approximately 35-150 million euros.   "
55903|NCT02553889|"     Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal     disease (ESRD) receiving chronic hemodialysis.   "
55904|NCT02553876|"     There are no studies as yet specifically investigating the application of DRG stimulation in     the treatment of chronic pain affecting the upper limbs. The investigators propose to     investigate the effect of dorsal root stimulation in patients with chrionic hand or upper     limb pain.   "
55905|NCT02553863|"     The purpose of this study is to determine whether a course of acupuncture is effective in the     management of peripheral neuropathy related pain in patients receiving chemotherapy.   "
55906|NCT02553850|"     This open non-randomized, single-arm, multicenter, observational study is designed to     evaluate the correlation between bone turnover markers and the response to treatment in     patients with breast cancer and bone metastases. In this observational study, ibandronate     (Bondronat) will be prescribed and used in accordance with the standards of care. Data will     be collected for 12 months.   "
55907|NCT02553837|"     This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating     Hantavax in Healthy Adult.   "
55908|NCT02553824|"     This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa     and binge eating disorder.   "
55909|NCT02553811|"     There is no golden universal standard for the diagnosis of Carpal Tunnel Syndrome (CTS). In     this scenario, for a comparison of the effectiveness of the principal diagnostic tests CTS     should determine how they affect the likelihood of disease through a clinical accuracy trial     of good methodological quality in order to get answers to what is the best diagnostic     strategy in clinical CTS practice. The paresthesia in nerve distribution territory median     hands is the most common symptom in patients with CTS. The nuisance caused by paresthesia     directly affects the quality of life of patients and impairs daily manual activities and     sleep quality. To evaluate the remission of paresthesia is a major clinical criterion for     improved STC being an expected relevant outcome for the patient. This study evaluated and     compared the diagnostic accuracy of the ultrasonography (US) and electromyography (EMG),     considering the postoperative status of remission of paresthesia as the reference standard in     the diagnosis of CTS.   "
55915|NCT02553733|"     In this study the investigators will test the hypothesis that short-term consumption of     inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow     responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with     peripheral arterial disease (PAD). Understanding and improving blood flow regulation in the     heart and skeletal muscles of patients with PAD is important because exercise triggers     symptoms of leg pain and substantially raises blood pressure and myocardial demand in these     patients.   "
55916|NCT02553720|"     The purpose of this study is to test whether addition of aquatic exercise to conventional     treatment helps reduce the adverse outcomes of deep vein thrombosis and reduce the severity     of chronic venous insufficiency.   "
55917|NCT02553707|"     This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in     participants with breast cancer and malignant bone disease, with moderate to severe pain. All     participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain     response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and     the target sample size is 182 individuals.   "
55918|NCT02553694|"     The purpose of this study is to determine how satisfied patients are when undergoing an     overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what     factors affect obstructive sleep apnea (OSA) treatment use.   "
55919|NCT02553681|"     This will be an up to six months, subject-masked, contralateral, parallel-group, randomised,     daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the     other eye. Data from the first four weeks of Test and Control lens exposure will be used for     the FDA 510 (k) submission.   "
55920|NCT02553668|"     Aim of the present study is to investigate the influence of hyperoxia on the protein     expression using the differential analysis of protein expression in tissues (proteomics). In     the study, blood and urine samples will be collected from participants who undergo a short     term hyperoxia using 100% oxgen for 3 hours.      Here, gel electrophoresis, protein separation and mass spectroscopy allow to identify     affected proteins. Based on these results, different induction factors of proteins will be     determined and then assessed using a bioinformatic network analysis regarding the cellular     influence.   "
55922|NCT02553642|"     The purpose of this study is to investigate the characteristics of tumors in patients treated     with nivolumab and to identify features that help to predict a good or bad response to this     drug.   "
55923|NCT02553629|"     This is a randomized control trial (RCT) that studies the surgical conditions during moderate     and deep neuromuscular blockade in 100 morbidly obese patients receiving elective     laparoscopic surgery for bariatric surgery.   "
55924|NCT02553616|"     Investigators will use a Solomon 4-group design to test the effectiveness of a brief     intervention to promote health behaviors for homeless youth who are 18-23 years of age. We     will recruit 300 youths from Austin, TX and 300 from Columbus, OH. We will gather     quantitative data on health behaviors and life satisfaction 3 and 6 months following the     intervention, which will be delivered on an individual basis. Data will be analyzed using     structural equation modeling and ANCOVA statistics.   "
55925|NCT02553603|"     This study is examining the effects of growth hormone releasing hormone (GHRH) on mild     cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects     with MCI as well as healthy controls.   "
55926|NCT02553590|"     To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree     allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual     therapy in special consideration of the chosen titration schedule in everyday practice.   "
55927|NCT02553577|"     There has been a dramatic escalation of electronic cigarette (e-cig) use among women of     childbearing age, including pregnant women. The overall goal of this study is to determine     the effects of e-cigs on prenatal biomarkers and birth outcomes. It is imperative that more     data about these effects be available to better inform women of childbearing age.   "
55928|NCT02553564|"     After a hospitalization, dialysis patients have a high risk of being admitted to the hospital     again within 30 days. The purpose of this research study is to test a new way of reducing the     chance of patients being hospitalized again. In this study investigator will evaluate a     checklist driven evaluation upon return to the dialysis facility as a method to reduce the     rate of rehospitalizations in hemodialysis patients.   "
55929|NCT02553551|"     The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to     reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded     randomized controlled trial.   "
55930|NCT02553538|"     Patient navigation (PN) has been shown to improve rates of cancer screening in vulnerable     populations. Most cancer PN programs are located in community health centers and focus on a     single cancer. We will evaluate the impact of PN program on breast, cervical, and/or     colorectal cancer screening in vulnerable patients receiving care in a large, academic,     primary care network using a population-based IT system.   "
56223|NCT02549716|"     This study compares the bioavailability of IV and PO acetaminophen in both blood and the     cerebrospinal fluid (CSF) of patients following subarachnoid hemorrhage. The study will also     compare the temperature and levels of inflammatory cytokines in both blood and CSF of     patients treated with IV and PO acetaminophen.   "
55931|NCT02553525|"     The purpose of this study is to measure the effects of non-regular temporal patterns of deep     brain stimulation (DBS) on motor symptoms and neural activity in persons with Parkinson's     disease (PD), essential tremor (ET) or multiple sclerosis (MS). These data will guide the     design of novel stimulation patterns that may lead to more effective and reliable treatment     with DBS. These data will also enable evaluation of current hypotheses on the mechanisms of     action of DBS. Improving our understanding of the mechanisms of action of DBS may lead to     full development of DBS as a treatment for Parkinson's disease and may lead to future     applications of DBS.   "
55932|NCT02553512|"     The purpose of this study is to demonstrate the use of a digital health offering in the     management of persistent hypertension during chronic anti-hypertensive treatment.   "
55979|NCT02552888|"     The proposed randomized controlled trial will test the safety and efficacy of combination     therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among     patients with chronic kidney disease.   "
55933|NCT02553499|"     In this study, participants with advanced solid tumors will be assigned to receive either     MK-1248 alone or in combination with pembrolizumab (MK-3475). This study will use an adaptive     design to find and confirm the maximum tolerated dose (MTD, or maximum administered dose     [MAD]) for MK-1248 alone and in combination with pembrolizumab.      Enrollment into this study has been prematurely discontinued due to program prioritization     and not related to any safety concerns.   "
55934|NCT02553486|"     This study evaluates the global quality of life of foreign born adopted children, one to     seven years following their arrival in France. Investigators will assess global health,     behavior, school integration for each child who arrived in France between 2008 and 2013,     through an online anonymous survey. Investigators, then, will identify variables associated     with a lower quality of life in order to improve the support offered to the children.   "
55935|NCT02553473|"     Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once     daily for two weeks + placebo for four weeks. Primary objective is to answer the question is     two weeks doxycycline treatment (currently suggested treatment) at least as effective as six     weeks doxycycline treatment in Lyme Neuroborreliosis?.Key secondary objectives are to     provide a better understanding of the pathogenesis and long‐term complaints, and to search     for new biomarkers in Lyme Neuroborreliosis (LNB) by collecting clinical data, blood, and     cerebrospinal fluid (CSF) in a biobank for future research      Endpoints:      Primary endpoint: Composite clinical score at six months after end of treatment.Secondary     endpoints: Fatigue Severity Scale (FSS),Patient Health Questionnaire (PHQ-15), Short Form 36     (SF-36) and blood and CSF findings at inclusion, after 6 and 12 months.      The study design is a multicenter, non-inferiority, randomized, penta-blind,     placebo-controlled trial. 250 patients will be included from Sørlandet Hospital and 5-10     other Norwegian hospitals.      Main inclusion criteria are neurological symptoms suggestive of LNB without other obvious     reasons, one or both of a) Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3) b) intrathecal     Bb antibody Production and signed informed consent. Safety assessments during the trial:     Comparison of clinical outcome six months after end of treatment between the two treatment     groups. Subjective experiences and blood tests including hematology and biochemistry for four     weeks after ended treatment.   "
55936|NCT02553460|"     The purpose of this study is to test the good and bad effects of the study drugs bortezomib     and vorinostat when they are given in combination with chemotherapy commonly used to treat     acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease     the number of leukemia cells, but it could also cause additional side effects. Bortezomib and     vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other     cancers in adults, but they have not been approved for treating children with leukemia. With     this research, we plan to meet the following goals:      PRIMARY OBJECTIVE:        -  Determine the tolerability of incorporating bortezomib and vorinostat into an ALL          chemotherapy backbone for newly diagnosed infants with ALL.      SECONDARY OBJECTIVES:        -  Estimate the event-free survival and overall survival of infants with ALL who are          treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.        -  Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.        -  Compare end of induction, end of consolidation, and end of reinduction MRD levels to          Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant          outcomes.   "
55937|NCT02553447|"     This randomized pilot early phase I trial studies how well cholecalciferol works in treating     patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low     levels of vitamin D (vitamin D deficiency). Cholecalciferol may increase levels of vitamin D     and improve survival in patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia     receiving standard of care chemotherapy.   "
55938|NCT02553434|"     After sustaining severe trauma to the chest, patients will often bleed into the chest cavity     pleural space) which is called hemothorax or they may also experience air leakage within the     chest cavity in combination with the bleeding (hemopneumothorax). The treatment for these     conditions include the insertion of a tube into the chest called a chest tube). Insertion of     the chest tube is commonly very painful for the patient due to the size or diameter of the     tube. Alternatively, procedure it is standard practice in the acute care setting at     Banner-University of Arizona Tucson Campus (B-UATC) to insert a pigtail catheter, which has a     smaller diameter, into the chest wall to treat the hemothorax or hemopnuemothorax. The     primary purpose of this study is to see if the use of the pigtail catheter is just as     effective as chest tube insertion in terms of removing leaked blood and/or air from the chest     cavity. An additional objective of this study is to evaluate which procedure is less painful     for the patient.   "
55939|NCT02553421|"     This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric     patients. Half the participants will be monitored by the device without infiltration     notifications and the other half will be monitored by the device with infiltration     notifications enabled.   "
55940|NCT02553408|"     Putting the limited use of titration algorithms in the context of escalating diabetes     prevalence rates, strategies and tools are urgently needed to help both patients and primary     care providers efficiently initiate and continue basal insulin therapy. Basel insulin is     considered to be the appropriate strategy after oral diabetic agent failure. This project     could set the stage for the need for a blood glucose meter with built-in algorithms designed     to support decision making by patients as well as care providers. Furthermore, the project     will evaluate the uptake and use of the newly developed Meter by Abbott Diabetes Care, which     was launched in Canada in October 2014, and its impact on primary care diabetes consultation.   "
55973|NCT02552966|"     It is postulated that the incompetence of the upper esophageal sphincter (UES) to restrict     passage of esophageal refluxate is fundamental to the development of LPR. The UES Assist     Device (UESAD) is a novel device that applies relatively modest external cricoid pressure,     which results in a 20 to 30 mmHg intraluminal UES pressure increase. Pepsin, a proteolytic     enzyme produced in the stomach, has been detected in the laryngeal epithelium of patients     with reflux associated laryngeal symptoms and implicated in the pathogenesis of     laryngopharyngeal reflux. This study will asses the effectiveness of a UESAD worn for 2 weeks     on LPR symptoms and salivary pepsin levels.   "
55974|NCT02552953|"     This is an open-label, single arm, dose escalation study in patients with advanced cancers.   "
55941|NCT02553382|"     Despite the availability of multiple medications for the treatment of Type 2 diabetes,     patients often continue to have difficulty attaining blood glucose targets and managing     cardiovascular disease risk factors. Recent trends in non-pharmacological therapy have     created a growing public interest in dietary supplements.      Research by this group and others support the benefits of whole grains, viscous dietary fibre     and ginseng in the management of diabetes. The current study investigates whether the     co-administration of a viscous dietary fibre blend, Salba (a grain rich in omega-3 fatty     acids), and 2 varieties of ginseng roots will further improve blood sugar control and     cardiovascular disease risk outcomes in individuals with Type 2 diabetes already receiving     conventional treatments.      Patients with Type 2 diabetes receiving the recommended intervention in accordance with the     Canadian Diabetes Association guidelines will be enrolled in a 6-month clinical study. Half     of the participants will be randomly assigned to a 4-component intervention that comprises     the co-administration of these four dietary/herbal supplements in addition to their usual     treatment regimen; the other half will continue their usual treatment regimen in addition to     taking high-oat fiber and wheat bran supplements.      The investigators hypothesize that an intensified, multi-targeted intervention with the     addition of these dietary and herb components will further improve long-term blood glucose     control and cardiovascular disease risk factors beyond conventional therapy. If this     combination of viscous fiber, Salba and ginseng is shown to be beneficial, these remedies     could complement current conventional therapy for Type 2 diabetes with the goal to further     improve health outcomes.   "
55942|NCT02553369|"     Late 2013, the first indigenous cases of chikungunya have been observed in the French     Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by     the outbreak.      During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack     rate was 38%. The most active period was three months.      In this context, knowledge of the attack rate and the epidemic in the Caribbean is an     important issue for outbreak management and modeling work.      As the chikungunya virus had never circulated in the Caribbean, determining the     seroconversion rate can be achieved by realizing a seroprevalence survey among the general     population at the end of the outbreak. Another simple method is to estimate the rate in a     cohort of patients followed regularly and whose habitat is distributed throughout the     territory studied.      The follow up of patients infected by the human immunodeficiency virus (HIV) in the French     West Indies is almost exclusively performed in hospitals in department of Infectious and     Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected     patients on all of our territories, allow to hypothesize that the risk of transmission of     arboviruses by exposure to mosquito bites is comparable to the general population. This     patient cohort is well suited to study the emergence of Chikungunya in the French West Indie     .      Primary objective :      To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the     French West Indies by estimating the prevalence of specific antibodies of chikungunya virus     in a sample (randomly constituted) from patients infected by HIV and representative of the     general population of Martinique and Guadeloupe      Secondary objective :      To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied     population To estimate the frequency of chronic forms of chikungunya in the studied     population   "
55943|NCT02553356|"     This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are     in general good health and selected for participation in the study according to the selection     criteria. This study will assess the effect of food on the pharmacokinetics of PT2385     Tablets. The study will consist of two periods and will be conducted in a crossover fashion.   "
55944|NCT02553343|"     The aim of the study is to assess the safety and immunogenicity of two formulations of the     high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent     influenza vaccine control in healthy elderly subjects aged 65 years of age and above.      Primary objectives:        -  To describe the safety profile of all subjects in each study group.        -  To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune          response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to          responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common          virus strains at 28 days post-vaccination.      Secondary objectives:        -  To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by          seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent          influenza vaccine and the licensed high-dose trivalent influenza vaccine.        -  To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by          GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose          quadrivalent influenza vaccine and the investigational high-dose trivalent influenza          vaccine.   "
55945|NCT02553330|"     A phase 2 study to find out if the drug INCB018424 Phosphate Cream is safe and has beneficial     effects in people who have alopecia areata (partial or complete hair loss) when applied to     the skin.   "
55946|NCT02553317|"     The study is a phase III, double blind, placebo-controlled, randomized study to evaluate the     efficacy and safety of caplacizumab in more rapidly restoring normal platelet counts as     measure of prevention of further microvascular thrombosis   "
55947|NCT02553304|"     Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western     countries; it is stratified as a subtype of indolent lymphoid malignancy with a long but     slowly progressive nature history. However, the clinical course of CLL actually varies     widely. Thus, many clinical and molecular features have been identified for outcome     predictions. The accurate predictions of prognosis through those factors help for the     decision making on the treatment, i.e. to treat patients of high risk of early progression or     poor overall survival (OS) with alternative or investigational therapies, while to avoid     unnecessary over-treatment for low-risk patients.      CLL is much less prevalent in Eastern countries; presently, most available data on CLL are     derived mainly from Western countries. However, a previous report concerning the epidemiology     of CLL in Taiwan revealed a drastic increase in the age-adjusted incidence of CLL, a trend     not found in Western countries where the incidence rate of CLL remained steadily stable over     time. In addition to this epidemiological difference, a population-based analysis has found     the overall outcome of CLL, estimated by relative survivals, is steadily much poorer in     Taiwanese patients than in US Caucasians. In another report about the cytogenetic profiles in     a small cohort of CLL patients in Taiwan, a novel cytogenetic abnormality was found to     correlate with poorer outcomes. These reports suggest the existence of ethnic differences in     the disease natures of CLL between the East and the West.      To delineate the possible underlying racial differences, especially in the molecular     prognostic profiles that might underlie the outcome disparity between Taiwanese and western     CLL patients, a comprehensive surveillance of the molecular profiles for CLL in Taiwan is of     importance. In this study, we are going to enroll around 250 CLL patients; their clinical     parameters will be recorded, their blood samples will be collected for a panel of molecular     and cytogenetic factor studies. The molecular markers to be tested in this project include     (but not limited to) cytogenetic abnormalities by fluorescent-in-situ hybridization (FISH),     immunoglobulin heavy chain variable region (IGHV) hypermutation status, gene mutations for     Notch1, SF3B1, p53, MyD88, and BIRC3, and the expressions for ZAP70 and stem cell factor     (SCF). These proposed markers include not only the conventional prognostic markers derived     from Western studies, and also some novel explorations from our preliminary results, such as     SCF and trisomy 3. Through this study, a comprehensive profile of CLL in Taiwan will be     established to identify the characteristics of CLL in Taiwanese patients and to address the     underlying factors of ethnic differences in the disease nature and outcomes of this disease.   "
56004|NCT02552563|"     This pilot study seeks to examine the extent to which, relative to usual care, a dementia     care management program for veterans and their caregivers (CGs)improves patient (e.g.,     behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden,     affect) outcomes.   "
55948|NCT02553291|"     HIV was once a fatal diagnosis, but due to treatment advances it is no longer a death     sentence. Today, HIV-infected adults face a new challenge to their health; they are     developing cardiovascular disease (CVD) earlier and more frequently than those not     HIV-infected. Reasons for this include toxic effects of HIV medications and activation of the     immune system. Preventing cardiovascular disease in HIV-infected adults will help them live     healthier lives; however, there is a lack evidence to help us to achieve this goal. Exercise     prevents cardiovascular disease, but it is often not addressed in HIV care, due, in part, to     a lack of practical interventions targeting this population. This study will address this     problem by testing an intervention to improve and maintain exercise in HIV-infected adults.      This study will examine the impact of an innovative and sustainable intervention, adapted to     the unique medical and psychosocial needs of HIV-infected adults, called SystemCHANGE-HIV. It     consists of six sessions to help redesign an individual's environment and routines to     increase exercise.This is a randomized trial in which half of the subjects will participate     in the intervention and half will participate in a control condition. Measures include     assessments of exercise, fitness, and the markers of cardiovascular health before and after     the intervention to see if, and how, they changed.   "
55949|NCT02553278|"     Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I     V3 device for non-invasive fat reduction vs. control.      All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with     VelaShape or Contour I V3 device.      Each arm will be treated with a different device:      Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I     V3 device   "
55950|NCT02553265|"     The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well     tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension     and normalize or reduce the exaggerated blood pressure variability in patients with familial     dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or     Riley-Day syndrome). Funding Source- FDA OOPD.   "
55951|NCT02553252|"     Patients with post traumatic stress disorder (PTSD) will be randomized to a 12-week     intervention of Sudarshan Kriya Yoga Trauma Relief Program (SKY) or a wait list control (WLC)     to assess the effects of this intervention on symptoms of PTSD, depression, anxiety, quality     of life, autonomic symptoms, and blood inflammatory markers.   "
55952|NCT02553239|"     This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle     tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed     CoolLoop® cryoablation catheter.      A further aim of the investigation is the evaluation of the efficacy and average duration of     the applied procedure.   "
55953|NCT02553226|"     Background:      The proposed study will investigate the effect of Syntocinon® (synthetic oxytocin) to induce     labour. The hypothesis to be studied is that once the active phase of labour has commenced,     Syntocinon® can be discontinued and the labour process will continue.      Design:      Double-blind randomised controlled multicentre trial      Setting:      Aarhus University Hospital, Denmark and Regional Hospital of Randers, Denmark      Population:      1200 women (600 in each group) stimulated in the latent phase of labour with oxytocin for     induction      Methods:      The Syntocinon® infusion will be replaced with either continuous isotonic saline (placebo) or     Syntocinon® infusion (control group), when the active phase of labour is reached.      Main outcome measures:      Caesarean section (primary outcome), tachysystole, neonatal asphyxia, birth experience      Perspective:      Syntocinon® is on the list high-alert medications and associated with complications for     mother and child during labour. Reducing the duration of stimulation during labour may lower     the number of asphyxial sequelae and the number of caesarean sections.   "
55954|NCT02553213|"     The aim of the study is to investigate, if bariatric surgery or the related caloric     restriction causes the significant improvement of glucose metabolism, which has been found in     bariatric patients.   "
55955|NCT02553200|"     The efficacy of breathing exercise with oscillated inspiratory loading and oscillated     positive expiratory pressure for airway secretion clearance and lung function in intubated     patients, both with and without mechanical ventilation dependence   "
55956|NCT02553187|"     The purpose of the study is to explore the efficacy and safety of Kanglaite Injection in the     treatment of patients with late-stage cancer cachexia.   "
55957|NCT02553174|"     The study will investigate the role of NSAIDs in the development of AKI in patients     undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the     use of new urinary biomarkers will allow earlier detection of AKI than the current gold     standard, i.e. changes in serum creatinine and/or urine output.   "
55958|NCT02553161|"     A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with     depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be     evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a     MRI scan and then randomized to treatment. Following randomization, high-risk youth will have     visits every week for the first 4 weeks of treatment then biweekly up to 16 weeks during     which time tolerability and ratings will be performed. MRI scan will be repeated at week 4.   "
55959|NCT02553148|"     A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used     to estimate the global need for palliative care for children aged 0-19 years. Prevalence     data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic     groups needing children's palliative care according to WHO and UNICEF guidelines.   "
55960|NCT02553135|"     Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The     study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients     will be required to attend a total of 11 study visits over a 24 month period with an     additional 3 year follow-up.   "
55961|NCT02553122|"     Total knee arthroplasty is a surgical procedure that involves a significant amount of blood     loss and it has always been the surgeons' goal to try to minimize blood loss. In the current     study, we will investigate the effect of blood loss after total knee arthroplasty with the     combination of Evicel, a fibrin sealant and Tranexamic Acid.   "
55962|NCT02553109|"     The optimal consensus concerning treatment of incidental small paraclinoid unruptured     intracranial aneurysms (UIAs) remains controversial. The aim of this prospective study is to     reveal the natural history of small paraclinoid UIAs with the goal of informing the treatment     plan.   "
55964|NCT02553083|"     The investigators will performed a large-scale multi center trial to compare the efficacy of     a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 300)     patients with Hp infection. Consecutive symptomatic patients will be recruited in Israel and     Spain when tested positive to Hp with serology and 13C urea breath test (13C-UBT) due to     symptoms. Patients with gastric cancer, MALT lymphoma, and younger than 18 or older than 80     years old will be excluded. All patients will be naive to eradication therapy and will be     randomized into one of three groups:      Group 1: Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days Group 2: Nexium 40 mg     and doxycycline 200 mg twice a day Group 3: Triple therapy of Nexium 20 mg, clarythromycin     500 mg, and amoxicillin 1gr twice a day for 10 days (regular accepted treatment).      All treatments will be stopped for a month and then 13CUBT will be repeated. The primary aim     of the study is to assess eradication success, intentioned to treat and per protocol in the     three treatment regimens.      The secondary aim of the study is to assess the safety of high dose amoxicillin and     doxycycline.   "
55965|NCT02553070|"     Inaccurate perceptions of the severity of an exposure may result in unnecessary visits to the     Emergency Department or Health Care Facility which can result in crowding of Emergency     Departments, unnecessary utilization of valuable health care resources, unnecessary     treatments, and or mistakes / errors resulting in harm to the patient.      Inaccurate perceptions about the severity of an exposure can result in delays in proper     evaluation and treatment resulting in harm or in some cases death of the patient.   "
55966|NCT02553057|"     Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury.     Since lung protective ventilation has been recommended during anesthesia to prevent ongoing     lung injury, so in our study the investigators will compare three different lung protective     strategies regarding their lung protective effect measured by the incidence of postoperative     pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator     release.   "
55967|NCT02553044|"     Total 25(OH)D is currently used as a biomarker of vitamin D status. However, there is some     debate as to whether total 25(OH)D is the best marker to use.      It has been suggested that free vitamin D may be better because it may be more biologically     available.      There are also some uncertainties about how we treat vitamin D deficiency. A single dose is     attractive because it is certain that the patient has had the dose and there is no     requirement for ongoing compliance, but it is still not clear what the best dose is to give.     Also, recent studies have highlighted that high dose vitamin D supplementation may increase     the risk of falling in older populations.      The investigators believe that studying how free vitamin D responds to different bolus doses     is the best way address some of the current research gaps, including what is the best     biomarker of vitamin D status, what is the mechanism of vitamin D toxicity and what is a safe     bolus dose to treat deficiency.      The investigators will study changes in total and free 25(OH)D, and also clinical response,     to three different bolus doses of vitamin D (50 000IU, 150 000IU and 500 000IU) in 84 vitamin     D deficient postmenopausal women, over a three month period with 5 study visits. A concurrent     control group of 28 vitamin D sufficient postmenopausal women will also be recruited.      This will allow the investigators to determine how total and free vitamin D change with bolus     dosing and whether there is a disproportionate rise in free 25(OH)D with higher doses that     may lead to hypercalcemia and falls.   "
55968|NCT02553031|"     This study will explore the potential value in proper therapeutic decision and clinical     outcome prediction by using integrated MR-PET system and advanced MR techniques in patients     with colorectal cancer.   "
55969|NCT02553018|"     The primary objective of the study is to compare, in patients treated with methotrexate     injection for rheumatoid arthritis, the compliance and the health assessment questionnaire     evolution for the administration by auto-injector versus administration by conventional     subcutaneous injection, after 6 months of treatment.   "
55970|NCT02553005|"     Rheumatoid Arthritis (RA) is a systemic inflammatory disease characterized by functional     disability and pain. Although acupuncture is widely used, western acupuncture studies on RA     show no conclusive positive result. Acupuncture is regarded as a reflex therapy, and     Traditional Chinese Medicine (TCM) diagnosis was shown to be an individual neurovegetative     state allowing to individually allocated acupoints. Positive results were reported using a     classical diagnostic procedure to allocate acupoints to the patient according to the Shang     Han Lun. The investigators are interested if acupuncture compatible with this ancient theory     would be successful in improve hand function in RA patients.      The investigators therefore developed a prospective randomized control trial in a three-armed     parallel group design with a standardized treatment intervention. Only patients with the TCM     diagnosis of a so-called Turning Point syndrome will be allowed in the experimental phase.     This may harmonize TCM diagnosis and the standardized intervention, in order to optimize     potential therapeutic effects.   "
55971|NCT02552992|"     This study is a pilot, randomized controlled trial to provide feasibility and conduct     preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga     intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have     demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes     are available to the public and a specialized yoga protocol for individuals with cLBP is     needed. This study's goal is to quantify trunk strength and flexibility to better understand     how these potential physical mechanisms specifically lead to improvement in pain-related     outcomes including pain and disability. This knowledge will be used to design a large scale     trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be     randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will     receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga     intervention will be offered weekly yoga classes and instructional materials will be provided     for home practice.   "
55972|NCT02552979|"     Positive reactions in atopy patch test in children with atopic dermatitis.   "
56005|NCT02552550|"     The curative treatment and organ preservation in advanced squamous cell carcinoma of the     oropharynx is multimodal. It involves induction chemotherapy and depending on the response     radio-chemotherapy or surgery. The combination of these methods has important functional     consequences.      The aim of this prospective pilot study is to describe swallowing, speech, but also patients'     quality of life before and after therapeutic management (existing studies measuring these     functions after treatment but not before).   "
55980|NCT02552875|"     Repetitive nerve stimulation is used to monitor the neuromuscular transmission function in     infants, children and adults after the application of muscle relaxants. During repetitive     stimulation of a motor nerve, amplitude of contractions of the corresponding muscle will     increase to a plateau (twitch potentiation), which is known as the staircase phenomenon.      There is no systematic information about the staircase phenomenon of the adductor pollices     muscle (ulnar nerve) in children between 1 month and 18 years .      In adults , a 50-Hz tetanus administered before initial twitch stabilization is able to     shorten the twitch stabilization period and to eliminate this staircase phenomenon.      The purpose of this study is to investigate the characteristics of twitch potentiation in     children between 1 month and 18 years by using acceleromyography.      In addition we investigate whether application of a 50-Hz tetanic stimulation is able to     eliminate the twitch potentiation like in adults.   "
55981|NCT02552862|"     Study Design: Double-blind placebo-controlled clinical trial      Study Duration:2 years      Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center)      Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in     patients with cirrhosis and SBP      Number of Subjects: 30      Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at     Hospital de la Santa Creu i Sant Pau      Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2     every 12 hours during hospitalization (n=15), or placebo (n=15)      Duration of administration: During hospitalization due to SBP episode      Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could     decrease bacterial translocation and systemic and cerebral proinflammatory state. This would     result in a faster SBP resolution, a decrease in the incidence of complications and an     improvement in cognitive function.   "
55982|NCT02552849|"     This is a multi-center, non-interventional study to assess and describe course and outcomes     in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet     (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity     (FVC) change from baseline on an ongoing basis.   "
55983|NCT02552836|"     The primary aim of this randomized controlled trial is to determine the acute antidepressant     efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson`s Disease.   "
55984|NCT02552823|"     Diabetes is one of the most common chronic diseases affecting Canadians (PHAC, 2011).     Lifestyle modifications that include a diet high in fibre may lower the risk of developing     type 2 diabetes (CDA, 2013). In this context, the presence of fibre in carbohydrate rich     foods has been widely recognized for its effect on post-prandial glucose response (PPGR).     Peas are high in fibre and protein and show great potential as a functional food. A health     claim for PPGR would increase market demand for peas, and help those who want to limit the     rise in blood sugar after a meal choose products to meet their goals, but there are several     gaps in the literature that need to be filled before a submission to Health Canada can be     successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin     response; 3) test varieties of peas that that currently available on the market; 4) test     whole/split peas (not fractions or isolates); 5) compare peas to appropriate starchy     reference food (rice or potato). The proposed study design will address all of these gaps in     the current literature and take into consideration Health Canada's guidance document for     health claims related to the reduction in PPGR, which sets out the criteria by which the     validity of such claims will be assessed.      Specific objectives        1. To determine the effect of 3 common market classes of peas on PPGR and insulin response          in a cross-over, randomized, controlled clinical trial.        2. To assess the effect of 3 common market classes of peas on appetite-related sensations          using visual analog scales.        3. To demonstrate whether the test and reference products were liked or disliked similarly          by participants.        4. To assess any gastrointestinal side effects from eating the test products   "
55985|NCT02552810|"     Contamination of implant abutments could potentially influence the peri-implant tissue     inflammatory response. The aim of the present study was to assess the radiographic bone     changes around customized, platform switched, abutments placed according to the     one-abutment-one-time protocol, with and without plasma of argon cleaning treatment.   "
59207|NCT02510573|"     The current study was designed to investigate the change of serum ficolin-3 levels and assess     the prognostic predictive effect of serum ficolin-3 levels in the patients with severe     traumatic brain injury.   "
55986|NCT02552797|"     Patients should be able to have a say in their care and treatment, but how this should work     for children and young people with mental health difficulties is unknown. For example, how     and when do young people want to be involved in decision making, and what is important to     them, their parents/guardians and healthcare professionals? This project will address these     questions and will develop a tool known as 'Power Up' to help young people with mental health     difficulties make decisions about their own care and treatment.      This project will run for 24 months and will:        1. Understand the beliefs, experiences, and values of young people, their parents/guardians          and clinicians around shared decision making (SDM) in mental health.        2. Use these responses to develop 'Power Up'; a tool to help young people make decisions          about their care or treatment in mental health services.        3. Pilot 'Power 'Up' in child and adolescent mental health services to estimate the number          of patients who would want to use Power Up and to see whether patients can be recruited          and followed up with measures. The pilot study would investigate randomisation, see how          clinicians cooperate, and identify barriers to collaboration and ways of overcoming          these.      Forty five young people, parents and clinicians will be recruited for interviews and focus     groups to inform tool development. Sixty young people aged 1116 will be recruited for the     pilot/feasibility study. Measurements will be collected at baseline, session by session, and     at the end of treatment.   "
55987|NCT02552784|"     The general objective is study medical, socioeconomic, behavioral, health environmental,     school and professional integration, and short- and medium- term quality of life determinants     for all patients under 18 years old, residing in France for which the diagnosis of inherited     metabolic diseases with specific regime (MHMRS) has been achieved during their childhood.   "
55997|NCT02552654|"     Intrusive memories of traumatic events are core features of posttraumatic stress disorder     (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this     study was to determine whether cortisol levels during an intrusion-inducing stressor     influence subsequent intrusive memories.   "
55988|NCT02552771|"     Multicentre, double-armed, randomized controlled trial designed to compare mitral valve     leaflet resection versus leaflet preservation with regards to the development of functional     mitral stenosis following surgical repair of mitral valve prolapse. Patients will be     randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral     valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed     by echocardiographic and clinical assessment at 12-months following surgery.   "
55989|NCT02552758|"     Investigators plan to explore whether Omega-3 fatty acid have effect on the violent behavior     of the schizophrenia patients. Investigators will use PET to explore the influence on     serotonin function of the brain to understand the mechanism of how Omega-3 fatty acid works.     This study will enroll 100 patients of schizophrenia with violent behavior.Participants will     be split into two groups randomly. In one group, participants will receive one pill of     placebo per day, and in the other, participants will have one pill of 900mg Omega-3 fatty     acid per day. This intervention will last 3 months.At week 0, week 4, week 8 and week 12,     some scales will be evaluated. Meanwhile, the density of eicosapentaenoic     acid(EPA),docosahexaenoic acid (DHA),noradrenalin(NE), dopamine(DA) and serotonin(5-HT) in     blood will be tested.At week 0 and week 12, 10 patients of each group will be randomly     selected to have the exam of PET.   "
55990|NCT02552745|"     This study is aiming to understand the effects of parecoxib on the postoperative     complications of hepatocellular carcinoma (HCC) patients undergoing hepatic transcatheter     arterial embolization (TACE). The investigators enrolled 242 patients who were diagnosed with     HCC for the first time and who received hepatic TACE at the Cancer Prevention and Treatment     Center of Sun Yat-sen University from October 2014 to March 2015 were prospectively enrolled.     The patients were divided into study and control groups according to whether parecoxib sodium     was administered postoperatively. Pain scores,body temperature, vomiting, and changes in     liver function after surgery, as well as the length of the hospital stay, were recorded and     compared.   "
55991|NCT02552732|"     The aim of this feasibility study is to provide data for a subsequent randomized controlled     trial to investigate if patient outcomes will be improved after an acute COPD exacerbation     using domiciliary nasal high flow therapy (NHF) compared to standard care. This feasibility     study will investigate the following: process, resources, management and scientific aspects     of delivering NHF as an adjunct therapy in COPD patients.   "
55992|NCT02552719|"     Purpose of the study is the validation of the German version of the Injustice Experience     Questionnaire.      Pretest: Participants were informed about the aims of the study and fill in a consent form.     They filled in a paper version of the German translation of the Injustice Experience     Questionnaire. In a structured interview patients were asked if there were any items     difficult to understand, unacceptable or offending them. Subsequently they had to answer     questions about the content and meaning of the IEQ-items.      Validation Study: Participants were informed about the aims of the study and filled in a     consent form. By e-mail they received an access link to the online survey. The questionnaires     of the survey could be filled in at home. The survey could be interrupted and terminated     later. About 20 minutes were needed to answer the 80 questions of the survey. All data was     saved anonymously during the survey.   "
55993|NCT02552706|"     The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture     probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight     infants.   "
55994|NCT02552693|"     This study evaluates the effectiveness of an enhanced package of support for activities     described in the Standard Operating Procedures (SOP) for Patient Tracing in Health     Facilities in Zimbabwe. This package is intended to increase the effectiveness of active     patient tracing activities by developing tools, providing mentorship and implementing     systematic review of processes to improve communication, coordination, and supervision     between community health workers and facility-based staff.   "
56006|NCT02552537|"     In patients with a walnut allergy double blind placebo controlled food challenge with walnut     will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the     impact of PPI on threshold level and on clinical manifestation.   "
56024|NCT02552303|"     The purpose of this study is to assess the effects of Armodafinil, CBT-I, or the combination     of the two on the sleep continuity of persons suffering from sleep disordered breathing and     their adherence to CBT-I and Continuous Positive Airway Pressure (CPAP). Adults diagnosed     with obstructive sleep apnea and who meet additional research and diagnostic criteria for     insomnia will be recruited. Participants will submit daily sleep diaries and supplemental     questionnaires as measures of study progress.   "
55995|NCT02552680|"     Introduction: Work-Related Musculoskeletal Disorders (WMSDs) are characterized by     inflammation of muscles, tendons, fascia and nerves of upper limbs, shoulder girdle and neck.     Its incidence is increasing and there is evidence of its association with the pace of work.     As WMSDs, another major public health problem is back pain, which also negatively influence     the quality of life of patients. These diseases affect many workers, among them, workers in     the health area, including surgeons. Studies show that many surgeons are suffering from     fatigue and musculoskeletal pain after undergoing surgery, especially laparoscopy. Regarding     the quality of life of doctors, a study indicates that surgeons have commitment of domains     Vitality and Pain. For these reasons it is important to develop strategies for prevention     of occupational risks (WMSDs) in this class of workers.      Objectives: To evaluate the influence of a Preventive Program (educational and gymnastics)     for prevention of WMSDs, in the quality of life, in limitation of the work, in intensity and     frequency of musculoskeletal pain in surgeons of the Hospital de Clínicas de Porto Alegre.     There will also be evaluated the effects of the program on muscular strength and flexibility     of medics participating in the Preventive Program.      Methodology: Randomized clinical trial with a sample of 54 surgeons, divided into two groups:     A (Intervention: will participate in eight meetings consisting of exercise and guidelines     on care and prevention of WMSDs in activities of daily living, especially those relating work     activities) and B (Control: will receive a manual-brochure - containing information about     general health). Participants will sign a Letter of Consent.   "
55996|NCT02552667|"     Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled,     multicenter phase 3 clinical trial.   "
84000|NCT02186613|"     The investigators will conduct a telephone-based support to breastfeeding women with healthy     newborns to improve breastfeeding outcomes.   "
55999|NCT02552628|"     Dystonia in Wilson's disease represent a major issue. The persistence of disabling motor     symptoms despite medical treatments justifies conducting a study on deep brain stimulation     (DBS) in Wilson's disease (WD). For bradykinetic patients, subthalamic nucleus (STN) could be     considered as a better target than the globus pallidus (GPi). For patients with hyperkinetic     dystonia, the internal globus pallidus (GPi) will be chosen as the target of DBS.      The investigators hypothesize that STN DBS will improve Wilson's disease patients, who,     despite copper chelators drugs, are still impaired by severe dystonia and akinesia (more or     less associated with other movement disorders).      The investigators primary objective is to demonstrate the efficacy of STN/GPi DBS on dystonia     associated with Wilson's disease.      Secondary objectives:        -  To evaluate the impact of STN/GPi DBS on other movements disorders (tremor,          Parkinsonism, chorea) observed in Wilson's disease.        -  To describe cognitive status of patients and to evaluate the consequences of STN/GPi DBS          on cognition and behavioral aspects of the disease.        -  To evaluate the consequences of the stimulation on speech and swallowing.        -  To evaluate the social impact of STN/GPi DBS in Wilson's disease.        -  To evaluate the safety of STN/GPi DBS in the specific context of Wilson's disease.   "
56000|NCT02552615|"     The aim of this study was to compare the effects of spinal stabilization and body awareness     in addition to brace wearing versus classical exercises on subjective verticality perception,     trunk symmetry and quality of life in AIS. Study included 30 AIS patients between the ages of     14.40±201 years (stabilization group), 14.2±2 years (Body awareness) and 13.60±1.65     (classical). Cobb angles, rotation, subjective visual (SVV), postural (SPV) and haptic (SHV)     and deformity perception, quality of life were assessed at baseline and after 10th week of     treatment. Cobb angle decreased in stabilization and awareness groups. Rotation decreased in     three groups. SVV improved in all groups. SPV and SHV, body asymmetry and cosmetic deformity     improved in stabilization and awareness groups. Only function improved with stabilization     treatment. Stabilization and body awareness exercises created positive changes in AIS.   "
56001|NCT02552602|"     Micronutrient deficiencies in people living with HIV have been reported. Multivitamins can     address micronutrient deficiencies, however the benefits of multivitamins in people living     with HIV is still debatable. While some multivitamin intervention studies have reported the     benefits of multivitamins in HIV infection, some other studies have reported no statistical     differences in outcomes of interest in intervention and control groups. With clear     differences in composition and strength of the multivitamins used in the different studies,     it is possible that some of the multivitamins used in some of the intervention studies may     have been unable to meet existing micronutrient deficiencies. Hence there is a chance that     higher strength multivitamins may be better able to correct these deficiencies and result in     better outcomes. This study will therefore compare three different multivitamins varying in     strength and composition to determine if any one of the three multivitamins will produce     better health outcomes.   "
56002|NCT02552589|"     The purpose of this double blind study is to prove whether a fluoride containing toothpaste     is able to reduce dental plaque and gingival inflammation in patients who have gingivitis     when applied twice daily during brushing at home over a period of 12 weeks.   "
56003|NCT02552576|"     This is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further     investigate the efficacy and safety of Voncento in subjects with Von Willebrand Disease (VWD)     in whom treatment with a Von Willebrand Factor (VWF) product is required as on-demand     therapy, for prophylactic therapy, or during surgery. Subjects will be treated with Voncento     either as an on-demand regimen (eg, to treat a non-surgical spontaneous or traumatic bleeding     event) or prevention regimen (eg, to prevent an anticipated bleeding event) at a dose     prescribed by the Investigator in accordance with the Voncento Summary of Product     Characteristics (SmPC), or with a prophylaxis regimen (regular treatment with Voncento at a     frequency of 1-3 times per week). Voncento will also be given to prevent and treat any     surgical bleeding events.   "
56025|NCT02552290|"     The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and     passive stretching to the upper trapezius on pressure pain thresholds and range of motion     (ROM) in individuals without recent complain of neck pain.   "
56007|NCT02552524|"     The gambling problem is characterized by a loss of control and an excessive focus on the     gambling practice. Currently, the treatment of pathological gamblers is often complex and     multidimensional, it notably includes psychological techniques including cognitive behavioral     therapy and the use of psychotropic drugs.      In pathological gambling and addictions, craving (or urge to play) and loss of control are     two essential clinical elements. The neurobiological level, they are associated with a     dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and     Goldstein, 2002).      One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation     (rTMS).   "
56008|NCT02552511|"     A Multicentre, observational and cohort study to get the incidence of new-onset or     newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain     electric activity and diagnose. Other data also will be collected since first seizure until     confirmed diagnosis.   "
56009|NCT02552498|"     Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the     gingiva in order to characterize the kinetics of the blood flow changes in human subjects.   "
56010|NCT02552485|"     Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension     in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as     latest clinical control ≥ 5 years.   "
56011|NCT02552472|"     This is a prospective cohort observational study of inhaler adherence in a community care     setting (ie. general practice clinics and pharmacies in the community).   "
56012|NCT02552459|"     The purpose of this study is to determine effect of combined medication of sufentanil and     dexmedetomidine in patient controlled analgesia after neurosurgery.   "
56013|NCT02552446|"     Indirect calorimetry is the gold standard to measure energy expenditure. In fact it is not     always available and inconstantly feasible. Various equations for predicting energy     expenditure based on body weights have been created. This study aims at determining the best     suitable predictive strategy unless indirect calorimetry is available.   "
85308|NCT02169427|"     The purpose of this study is to determine the rate and routes of excretion of OPC and the     mass balance in urine, faeces and expired air.   "
56016|NCT02552407|"     During primary percutaneous coronary intervention, distal embolization of thrombus and     impaired microvascular perfusion has been associated with an increased mortality.     Thrombectomy devices during primary percutaneous coronary intervention may prevent distal     embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce     mortality.   "
56017|NCT02552394|"     This clinical trial is for men with advanced prostate cancer that may have spread to other     parts of the body.      Currently, once prostate cancer cells have spread from the prostate to other organs it is not     treatable by surgery. The purpose of this study is to treat patients with an experimental     antibody (i.e. that has not been FDA approved) called J591 that attaches itself to a special     protein on cancer cells called PSMA to try to eliminate these cancer cells (called     circulating tumor cells) from the circulation.      In the initial phase of the study, 6 participants will receive the experimental J591     treatment. Routine blood tests, research blood tests, physical exam will be performed at each     visit. Participants will also be asked to complete a questionnaire about how they are     feeling. Participants will have a radiographic scan every 3 months to check the status of     their disease.      Participants who tolerate the treatment well may be re-treated at the same level every 3     months, and may continue on treatment as long as they are responding to therapy and not     experiencing unacceptable side effects.   "
56018|NCT02552381|"     The purpose of the study is to assess the fibrin structure marker in the plasma of cancer     patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to     determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients     without treatment and in patients under LMWH treatment will be recorded, depending on the     location and type of cancer, metastases, and treatment of cancer.   "
56019|NCT02552368|"     The ultimate goal of this project is to develop a functioning and clinically feasible method     for restoring function to motor-impaired stroke survivors. This ultimate goal will be     approached through two different means. The first method is to develop a functioning     brain-computer interface that operates based on cortical activity ipsilateral to an intended     movement on the motor-impaired side of the body. And secondly, to develop new methods of     rehabilitation that involve stimulating peripheral muscles based upon cortical activity     ipsilateral to intended movements. Finally, the study seeks to assess changes in functional     connectivity as a result of using a BCI device.   "
56020|NCT02552355|"     The investigators propose that post-exercise milk protein feeding will enhance the     mitochondrial protein synthesis (biogenesis) response to an exercise-training program. In     addition, the investigators propose that this stimulatory effect of protein feeding will     overcome the potential blunting effect of metformin on exercise responses. The investigators     will investigate these outcomes over a 12-week exercise-training program in older adults with     pre-diabetes with or without metformin treatment.   "
56021|NCT02552342|"     The purpose of the present study is to assess the efficacy of methylprednisolone as an     adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).      The hypothesis of the study is that methylprednisolone can decrease the mortality of severe     CAP without any significant side effects,with reduction of the time to clinical stability and     failure rate of treatment.   "
56022|NCT02552329|"     Most research on Tai Chi has been done in the area of balance and falls. Studies examining     the effects of Tai Chi exercise on cognitive function are sparse especially in the population     of MCI. Therefore, the aims of the present study are: 1) to examine the effects of Tai Chi     exercise on cognitive function of elderly with MCI, and 2) to investigate the effects of     6-month Tai Chi exercise on serum biomarkers in individuals with MCI.   "
56023|NCT02552316|"     The ASPIRE study is a clinical trial designed to examine the microbes (e.g., bacteria) within     psoriasis skin lesions compared with normal skin. The investigators will also examine the     effect of NB-UVB (narrow-band ultraviolet B) phototherapy (i.e., light therapy) on skin     microbes.   "
56026|NCT02552277|"     This is a Phase 2, randomized, double-blind, placebo-controlled, dose range finding study in     subjects who have diabetic peripheral neuropathy (DPN). The study will enroll approximately     24 subjects. Subjects will be randomized to receive one of 3 treatments: PDA-002 (3 x 10^6     cells), PDA-002 (30 x 10^6 cells), or placebo (vehicle control) in a 1:1:1 randomization     approach. Investigational product or placebo will be administered monthly (3 administrations     total on Study Days 1, 29, and 57).   "
56027|NCT02552264|"     The Behaviour Change Institute (BCI) was created in 2008 within Capital Health to provide     healthcare providers with evidence-based skills in helping patients change. In addition, the     BCI has also become a resource within the organization to assist with other needed changes,     such as helping healthcare providers use new or different procedures to provide better     patient care. Through our work at the BCI we have identified the need to help healthcare     providers to better cope with change. The purpose of this project is to implement and to     evaluate an evidence-based professional resiliency training program for staff to help them     better cope with change. This professional resiliency training program is based on an     empirically supported form of therapy called Acceptance and Commitment Therapy. The training     takes the form of a hands-on, applied workshop designed to increase resiliency and     flexibility in a workplace setting.   "
56039|NCT02552108|"     Generalized Anxiety Disorder (GAD) is a chronic condition that is characterized by excessive     and uncontrollable worry and anxiety. In Canada, 3 to 4% of the population suffer from GAD at     any point in time. These individuals have a lowered quality of life and are at risk for many     medical conditions such as coronary heart disease and cancer. Research suggests that both     pharmacological and psychological approaches are effective for treating GAD in the     short-term; however, psychological treatments appear to offer the greatest long-term     benefits. There exist a number of effective psychological treatments for GAD, most of which     fall into the category of cognitive-behavioural therapy or CBT. In the 1990s, a group of     Canadian investigators developed a CBT protocol for GAD that included four components. Data     from five clinical trials suggest that one of the four components is particularly important     for treatment success: experiencing uncertainty rather than avoiding it in everyday life.     Stated differently, learning to tolerate and deal with uncertainty appears to be the key to     decreasing worry and anxiety. Given this finding, the investigators have developed a new     treatment that exclusively targets intolerance of uncertainty: Behavioural Experiments for     Intolerance of Uncertainty or BE-IU. The goal of the current proposal is to test the efficacy     of BE-IU by comparing it to a Waiting List (WL) control condition. A total of 50 participants     with a primary diagnosis of GAD will be randomly assigned to either BE-IU or WL and will be     assessed at 5 time points ranging from pre-treatment to 12-month follow-up. The conditions     will be compared in terms of treatment efficacy and mechanisms. The investigators will also     examine the predictors of change during the 12-months following treatment. The proposed study     will produce data on the efficacy and mechanisms of a treatment for GAD that is less costly,     less complex and easier to disseminate than treatments that are currently available.   "
56028|NCT02552251|"     Congenital adrenal hyperplasia (CAH) results from a deficiency of a key enzyme in the     biosynthesis of cortisol, mainly 21-hydroxylase, resulting in its classic form a neonatal     salt loss syndrome and / or a virilization syndrome in girls. The treatment of the disorder     in adulthood involves administering steroidal compounds with the aim to substitute the gluco-     and mineralocorticoid deficit on the one hand, and effectively curb the adrenal hyperplasia     and adrenal androgen pathway in girls . The terms of glucocorticoid treatment are not clearly     codified and are based on several steroidal compounds and various protocols. The advantages     in terms of adrenal suppression and disadvantages - including bone and metabolic - different     treatments have not been clearly established in the literature. The main objective of this     study is to compare among adults with HCS in its classical form the impact on hormonal     parameters adrenal suppression glucocorticoid of 3 types of treatment administered to     equivalent dose and according to the usual procedures. The secondary objective is to compare     in the same patients the impact of different drugs and treatments on several metabolic bone     parameters. The study will include 40 adult patients bearing a HCS in its classical form and     will include 3 treatment sequences of eight weeks each, during which they will be     administered sequentially in random order at random and according to the known equivalences     hydrocortisone, prednisone (CORTANCYL) and dexamethasone (DECTANCYL).      Randomization will be stratified based on previous DMARDs in the investigation that may be     different for different patients, knowing that France hydrocortisone and dexamethasone are     used mainly for the treatment of congenital adrenal hyperplasia. The judging criteria will     be: i) the criteria of adrenal hormone suppression: plasma levels of testosterone,     androstenedione, 17 OHP, ACTH and diurnal variations of the 17 OH progesterone salivary ii)     the criteria of the metabolic impact of glucocorticoids: plasma glucose levels , blood     lipids, and insulin sensitivity index HOMA-R calculated from glucose and insulin, iii) the     criteria of bone impact of glucocorticoids: plasma for CTX bone resorption and bone alkaline     phosphatase P1NP for bone formation iv) the living quality criteria evaluated by the PGWB     Questionnaire (Psychological General Well-Being). The duration of the study period will be 24     months.   "
56029|NCT02552238|"     The purpose of this study is to assess the safety and efficacy of Lumason-enhanced dobutamine     stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border     delineation (LV EBD) at rest and who are scheduled for coronary angiography.   "
56030|NCT02552225|"     The study will compare the effectiveness of amitriptyline versus placebo (inactive     medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned     at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen     in the clinic at baseline and at 8 weeks. Improvement will be measured using standardized     symptom scales, and a self-reported subjective improvement percentage.   "
56032|NCT02552199|"     To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria     for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.   "
56033|NCT02552186|"     Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical     repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to     classify PE severity. Calculation of the PI requires cross-sectional imaging of the chest,     usually with computed tomography (CT) or Magnetic Resonance Imaging (MRI), to obtain the     necessary measurements. However, CT delivers a high dose of ionizing radiation, which carries     cumulative long-term risks of malignancy and MRI can be costly. The purpose of this study is     to develop a method whereby accurate chest wall measurements can be obtained to quantify PE     severity without the need for cross-sectional imaging.   "
56034|NCT02552173|"     Investigators prospectively evaluate the accuracy of intraoperative stem anteversion in     40consecutive total hip arthroplasties.   "
56035|NCT02552160|"     Prospective, multi-centre, non-interventional study to collect findings about the effects of     LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination     preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life     under real conditions and to find out what types of patients are selected for this therapy by     physicians.   "
56036|NCT02552147|"     Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or     aggression, which can interfere with functioning. The purpose of this pilot study is to test     whether transdermal nicotine is effective for irritability and/or aggression in adults with     ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in     three visits. At the first visit, subjects are screened for eligibility and enrolled.     Baseline measures include rating scales and a frustrative computerized task. They will then     wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study     measures are repeated, vital signs and side effects monitored. Subjects will return for a     third and final visit on day 21 to repeat the study measures performed during visit two.   "
56048|NCT02551991|"     This is an open-label, phase 2 comparative study to assess the safety, tolerability, and     efficacy of nal-IRI in combination with other anticancer therapies, compared to     nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have     not received prior chemotherapy. This study will assess the following regimens:        -  nal-IRI + 5-FU/LV + oxaliplatin        -  nal-IRI + 5-FU/LV        -  nab-paclitaxel + gemcitabine      The study will be conducted in two parts:        1. a safety run-in of the nal-IRI + 5-FU/LV + oxaliplatin regimen, and        2. a randomized, efficacy study of nal-IRI + 5-FU/LV + oxaliplatin, and nal-IRI + 5-FU/LV,          versus nab-paclitaxel + gemcitabine.   "
59208|NCT02510560|"     The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm     infants.   "
56037|NCT02552134|"     Background: More than 10% of the adult population in Styria, a federal state in the south of     Austria, is allotted to a stationary stay at a health resort each year. In practice     approximately 50.000 adults receive these stays that are financed from the health insurance     companies and that last up to 3 weeks. The target group for theses stays is the general     population aged between 30 and 65 years that shows minor health deficits like back pain or     risk factors for cardio-metabolic diseases. The treatment during the stays consists of     exercise, nutritional and psychological interventions. Thus the increase of physical activity     is an important goal that is focussed during the stationary stay. Because of the absence of     regional facilities that are linked to the resorts and that provide accesses to standardised     regional programmes sustainability is questionable.      Methods/Design: This prospective controlled open label study compares two study groups. After     a stationary stay at a health resort patient are allocated to a standardised, regional     sports-club based exercise programme or to another group, where only written hand-outs are     provided. The primary outcome is the weekly level of health enhancing physical activity which     is objectively measured with an accelerometer and an activity log-book. Additionally, social     determinants are requested, fitness and anthropometric measurements are done at baseline     until 12 months. Beside the changes in measurable parameters, processes are evaluated     accurately. Consequently the gateway - function of the health resort is analysed.      Discussion: The structured cooperation between the health sector, where health resorts     informing and assigning patients to regional sports-clubs and the sports sector potentially     provides a wide network of standardised programmes. Within this study we aim to evaluate the     sustainability of stationary stays and a continuing regional standardised exercise programme.   "
56038|NCT02552121|"     The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC)     in a mixed population of patients with specified solid tumors   "
56040|NCT02552095|"     The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee     Replacement (PKR) with the Japanese population. It is expected that patients who receive the     Triathlon PKR will achieve excellent clinical results without adverse effects and that the     device fits well with Japanese morphology.   "
56041|NCT02552082|"     The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability     (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship     between these parameters and clinical outcomes will be evaluated as well as the importance of     rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes     and perform the same or better than other total knee implants.   "
56042|NCT02552069|"     The purpose of this study is to evaluate early fixation and stability of the Tritanium cup.     It is expected that the Tritanium® cup will be equal to or better than conventional     cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.   "
56043|NCT02552056|"     This randomized controlled trial will compare the effect of a CAMH integration package on     yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses,     midwives and clinical officers who provide PHC services to children and adolescents in 42     health centers; and eligible traditional healers.   "
56044|NCT02552043|"     The aim of this study is to evaluate the efficacy of a long-term domiciliary exercise program     using the Wii video game platform as a training modality in Cystic Fibrosis (CF) patients.     Investigators hypothesize that an exercise program performed by active videogames (AVG) will     produce an improvement in exercise tolerance and muscular strength to be maintained over time     in young CF patients.   "
56045|NCT02552030|"     In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S)     to determine systolic blood pressure (RR) and compare it to conventional oscillometric     measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and     perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person.     Primary parameter will be the absolute difference (Delta) between the correlating blood     pressure measurements in mmHg.   "
56046|NCT02552017|"     The purpose of this study is to determine if a new device, called the Endocuff Vision (a     small plastic device attached to the end of the colonoscope which helps by holding the folds     of the bowel back to give a clear view of the inside of the bowel) will significantly improve     the detection of adenomas when used in all patients referred for colonoscopy.   "
56047|NCT02552004|"     Intraoperative histological examination is a fundamental tool in surgery. Probe-based     Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time,     microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate     pCLE in surgical setting. The objective is the depiction of histological rendering of normal     and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be     assessed. All surgical conditions usually necessitating frozen section will be investigated.     A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach,     esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic     criteria will be defined by a surgeon - pathologist team and further validated by     retrospective analysis of the video sequences in comparison to conventional histology slides.     The data will be used to create an image bank of reference optical biopsy images. The study     will allow to point out the surgical conditions in which pCLE is the most effective and     reliable and could eventually replace the frozen section technique.   "
56272|NCT02549079|"     The present study investigates the levels of certain soluble factors in the blood of patients     with severe burn injury. Serum levels of different soluble factors will be correlated with     the clinical outcome, presence of sepsis, the area of burn, and other clinical parameters in     order to make a statement regarding their use as biomarkers in the prediction and monitoring     of burn patients.   "
56049|NCT02551978|"     Obesity and its associated comorbidities are becoming a key and rapidly growing public health     problem. The cause of obesity is an imbalance between energy intake and energy expenditure in     favor of the former. Childhood and adolescence are seen as critical time for its development.     It is therefore crucial to provide both prevention and treatment actions already during     childhood. The prevention and treatment weight-management programs in children focus on     improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One     important basic requirement for any weight-management program is, that both children and     their families are motivated and ready for change. Video games, including exergames, serious     games or combined approaches offer additional chances in the treatment and prevention of     obesity by approaching children in their environment and motivating them to deal with     life-style topics.      The investigators developed a motion-controlled serious game for children aged between 9 and     12 years, addressing all the three core areas nutrition, physical activity, and psychosocial     factors. In addition to the motion control, a tablet is used for knowledge-based and     cognitive tasks. In comparison to other studies the nutrition part not only deals with the     food pyramid but also with the energy density of foods and liquids and offers a     self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects,     especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises.     The game consists of two sessions, having each a duration of about 35 minutes.      The aim of this study is to evaluate the program in a cluster-randomized controlled trial in     a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of     the same school will be randomly allocated to an intervention and a control group. The     intervention group will play the game within two weeks, whereas the control group will     receive basic information. At baseline, two weeks after baseline and at four weeks follow-up,     measurements will be performed. The primary outcome of the study is the gain of knowledge     (nutrition, psychosocial aspects) measured by a self-constructed questionnaires tailored     specifically for the serious game. Secondary outcomes are the acceptance of the game, changes     of nutrition behaviour, physical activity and intentions of the children to follow a healthy     lifestyle, measured by mostly validated questionnaires.   "
56050|NCT02551965|"     In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the     clinical risk factor of exhaustion, the researchers propose to conduct a prospective     observational study during 6 months phone follow up of the caregivers. The recruitment will     take place during the oncogeriatric assessment consultation.   "
56051|NCT02551952|"     INTRODUCTION: Cognitive dysfunction is a frequent adverse event in the postoperative period,     especially in elderly patients. The tests commonly used for the detection of postoperative     cognitive dysfunction are time-consuming and with variable sensitivity and specificity and     difficult routine use. Applying a difficult battery of cognitive tests decreases the     viability of adopting measures to increase preoperative cognitive reserve and methods for     prevention, diagnosis and rehabilitation of cases of Postoperative Cognitive Dysfunction     (POCD), it is desirable to search for alternative methods diagnoses.   "
56052|NCT02551939|"     A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast     augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1     year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and     well-being of patients during the preoperative and 1 year post operation.   "
56067|NCT02551744|"     Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in     thienopyridine users remains unclear.   "
56053|NCT02551926|"     Prehypertension is a predisposing condition for morbidity inhypertension and cardiovascular     diseases. Health education via electronic pathways such as mobile text messaging or virtual     communities may provide more availability and adherence than printed media. Regarding lower     costs of such electronic resources and continuity of interventions through these ways,     assessing their effectiveness compared to a printed material may help health educators to     choose proper methods for improve their educational attempts. Therefore, the current study     aims to compare different tools for health education about healthy lifestyle in people with     prehypertension. For this, educational interventions with similar content among 3 groups of     people will be conducted (i.e., first group via mobile text messaging, second group using     virtual communities, and third group by brochures as a printed media). A control group also     will be considered without any intervention. Several phases are considered in the study. In     phase 1 using health centers located in Qazvin city, people would be invited to a free     screening program of prehypertension. Then, an eligible sample will be divided in three     groups using a random allocation process (each one including 100-150 people with     prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II) will     be measured before intervention. A standard educational content using approaches of lifestyle     promotion defined in HPLP II would be available for intervention groups during a time period     of 1 month concurrently. At final phase, one month after termination of intervention blood     pressure as primary outcome and lifestyle changes along with self-efficacy for lifestyle     modification as secondary outcomes will be measured. This study may suggest effective ways     for health education which is applicable by health care professionals to promote health     status among peopleat risk of hypertension.   "
56054|NCT02551913|"     Sleep education has been used as a method of primary and secondary prevention of sleep     problems in all age groups. An especially vulnerable age group are adolescents who frequently     have poor sleep habits and suffer from sleep deprivation. In adolescents, insufficient sleep,     inadequate sleep quality, and irregular sleep patterns are associated with daytime     sleepiness, negative moods, increased likelihood of stimulant use, higher levels of     risk-taking behavior, poor school performance, and increased risk of unintentional injuries.     As an US study has shown, sleepiness was the major causal factor in many traffic accidents     and more than 50% of sleep-related crashes involved drivers aged 25 or younger. The study was     aimed to evaluate the effectiveness of a theory-based sleep hygiene intervention in improving     sleep quality in adolescents.   "
56055|NCT02551900|"     Warm water based cycling exercise training would more favorable than cold water based cycling     exercise training and land based cycling exercise in vascular function in type 2 diabetic     patients.   "
56056|NCT02551887|"     Primary, Secondary, and Exploratory Objective(s):      Primary objective: To evaluate the effect of interventions on 1st dose uptake of HPV vaccine.   "
56057|NCT02551874|"     This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM)     will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin     and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects     receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a     treatment period of 52 weeks.   "
56058|NCT02551861|"     The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or     without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected     patients without advanced fibrosis or liver cirrhosis who have never been treated previously.   "
56059|NCT02551848|"     The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected     utilizing kinematically-based injection parameters for the treatment of upper extremity     essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment     tools in determining injection parameters and to study the composition of tremor using     kinematics.   "
56060|NCT02551835|"     This meta-analysis will be conducted to study the effect on vitamin D supplements on markers     for cardiovascular disease and diabetes using individual participant data from 12 RCTs. Given     that previous data suggest that vitamin D supplementation might be most effective in those     individuals with very low 25-hydroxyvitamin D (25(OH)D) and potentially harmful in those     achieving very high levels after vitamin D supplementation, this meta-analyses will be     performed in subgroups according 25(OH)D levels.   "
56061|NCT02551822|"     The investigators objective is to compare patient outcomes as changes in validated symptom     measures of overactive bladder, the Overactive Bladder Questionnaire Short Form (OABq-SF)     symptom scale, between women who are set on cycling versus continuous programs for their     neuromodulator. Specifically, the investigators propose to perform a randomized double blind     crossover study in women who are successfully treated with neuromodulation to either     continuous or cycling mode on the modulator and compare differences between groups on the     validated OABq-SF symptom questionnaire. In addition, the investigators will compare     differences in urinary frequency and pad counts between women randomized to cycling versus     continuous stimulation as measured by a 3 day voiding diary. This investigation will provide     evidence-based guidelines for neuromodulator programming.   "
56062|NCT02551809|"     The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine     (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and     immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the     secondary endpoint.   "
56063|NCT02551796|"     To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators     after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond     laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.   "
56064|NCT02551783|"     This is a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa     graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of     repairing the strictured urethra. Current evidence suggests the two approaches for placement     of the graft are equally successful at correcting the stricture and the two approaches have     similar risks of complications. The investigators propose to randomly assign appropriately     selected patients to either a dorsally- or ventrally-placed graft. No additional procedures     beyond the normal care protocol will be required of the patients. Success will be assessed     via objective and subjective methods; complications will be tallied in a standardized     fashion. Outcomes will be measured at two years.   "
56065|NCT02551770|"     The aim of this controlled study is to assess the clinical outcomes and patient reported     outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct     (test treatment) or without Straumann Emdogain (control treatment).   "
56066|NCT02551757|"     The purpose of this study is to assess the effect of continuous positive airway pressure     (CPAP) on functional outcome in patients with acute stroke, the investigators conducted a     sham-controlled, double-blind pilot trial during inpatient rehabilitation.      Patients with acute stroke were recruited and randomly assigned to auto-titrating or     sham-CPAP during their rehabilitation stay.   "
56069|NCT02551718|"     This pilot clinical trial studies the feasibility of choosing treatment based on a high     throughput ex vivo drug sensitivity assay in combination with mutation analysis for patients     with acute leukemia that has returned after a period of improvement or does not respond to     treatment. A high throughput screening assay tests many different drugs individually or in     combination that kill leukemia cells in tiny chambers at the same time. High throughput drug     sensitivity assay and mutation analysis may help guide the choice most effective for an     individual's acute leukemia.   "
56070|NCT02551705|"     Huntington's disease (HD) is a genetic progressive fatal neurodegenerative disorder. In the     western world it affects 5-10 persons per 100000. The main brain changes include the loss of     brain cells in subcortical structures. The symptoms of HD include involuntary movements,     cognitive deterioration and behavioural disturbances. It has been shown that changes in     emotion comprehension occur before the onset of the motor symptoms (preHD). This deficit in     perception of emotions has been primarily investigated by means of facial expressions.     However, emotions can also be expressed through body language. Here, the investigators     propose to investigate whether the emotion comprehension deficit in preHD also includes body     language comprehension.   "
56071|NCT02551692|"     The goal of this study is to evaluate the effects of varenicline versus nicotine replacement     versus placebo on personal smoking environment cue (PSE) reactivity. The results of this     study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine     patch, varenicline) alter reactivity to environment cues. The investigators propose to     identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1     training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check     sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC;     n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind,     double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will     be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking)     repeated measures ANOVAs with random-effects. The investigators hypothesize that personal     smoking, as compared to nonsmoking environments, will be associated with greater reactivity     (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x     Environment interaction will be characterized by decreased reactivity to smoking as compared     to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.   "
56072|NCT02551679|"     The primary objective of this study is to determine the efficacy and safety of intramuscular     injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical     limb ischemia who are receiving standard of care therapy and have no endovascular or surgical     revascularization options.   "
56073|NCT02551666|"     The goal of this translational research study is to evaluate the efficacy and feasibility of     balance recovery training as an on-site fall prevention exercise intervention for older     adults living in retirement communities. Falls are the leading cause of injuries and     injury-related deaths among older adults over the age of 65 in the United States. While it is     generally accepted that exercise helps prevent falls, exercise does not always reduce the     number of falls, and it remains unclear which types of exercise are most effective at     preventing falls. Balance recovery training (BRT) is a novel exercise intervention that has     that has the potential to decrease the number of falls among older adults by improving their     balance recovery ability after common balance perturbations such as tripping. BRT involves     repeatedly exposing individuals to postural perturbations in a safe, controlled setting that     allows reactive balance recovery to be practiced and improved. The investigators will     administer BRT on-site at continuing care retirement communities over four weeks to older     adult fallers and determine its effects on balance recovery ability over the following six     months compared to another group of older adult fallers performing Tai Chi as an alternative     exercise intervention. To further address the potential for BRT to be translated into typical     practice within retirement communities, the investigators will also collect data on     facilitators and barriers to the long-term sustainability of BRT in retirement communities     using qualitative methods. These quantitative (balance recovery ability) and qualitative     (implementation process) measures will provide the basis for a subsequent large practical     clinical trial to test the effectiveness of BRT on reducing the number of falls among older     adults.   "
56074|NCT02551653|"     Pulmonary arterial hypertension (PAH) involves the narrowing of blood vessels connected to     and within the lungs. Focal adhesion kinase (FAK) is a focal adhesion-associated protein     kinase involved in cellular adhesion and spreading processes which leads to stiffening and     thickening of blood vessels in lungs. This further increases the blood pressure within the     lungs and impairs their blood flow. This study aims to demonstrate biodistribution of FAK     inhibitor, GSK2256098, in cardiopulmonary sites i.e. heart and lung tissues. The uptake of     11C-radiolabelled GSK2256098 within the lung and / or heart of healthy subjects and     idiopathic pulmonary arterial hypertension (iPAH) patients will be assessed using Positron     Emission Tomography (PET). Based on study results the decision as to whether a follow-on     phase 2 trial should be initiated to investigate the therapeutic utility of GSK2256098 in     iPAH will be decided. Sufficient number of subjects will be screened (up to 30 days prior to     scan) to enrol 12 healthy subjects and 12 PAH patients in the study. Enrolled subjects will     receive a microdose of [11C]-GSK2256098 on a scanning day which will be followed by the     follow-up visit (2-4 weeks post-last dose).   "
56075|NCT02551640|"     The goal of this study is to explore the effects of FeatForward on physical activity and     cardio-metabolic risk factors. The study will be implemented as a 2-arm randomized controlled     trial (RCT) comparing the effects of FeatForward in patients assigned to use the application     versus a control group who will not use the app over a 6-month follow-up period. The     investigators hypothesize that subjects using FeatForward will be more physically active and     will achieve greater improvements in their cardio-metabolic risk (CMR) factors than a usual     care control group that will not use the app over a 6-month period.   "
56076|NCT02551627|"     This will be a double blind, two-arm, parallel-group, stratified for gender, randomised,     controlled study in participants aged 7-10 years (yrs). The aim of the study is to test the     hypothesis that MMN fortified beverage may help improve immunity outcomes as assessed through     vaccine response in 7-10 yrs old school participants.   "
69702|NCT02373462|"     To study the effect of olmesartan on walking distance and quality of life in peripheral     artery disease patients with hypertension treated For intermittent claudication.   "
56077|NCT02551614|"     This is an exploratory study to further develop an imaging platform for the assessment of     whole lung neutrophil retention. The primary objective of the study is to quantify and     compare neutrophil retention in the lungs of lipopolysaccharide-challenged healthy subjects,     saline-challenged healthy subjects and subjects with stable COPD. There will be two treatment     groups, one with healthy subjects and the other with subjects with stable COPD. The total     duration of this study for healthy subjects will be approximately 1 week, in addition to the     screening window of 28 days. The total duration of this study for subjects with COPD will be     approximately 1 week for those that complete Visit 1 only, and approximately 2 weeks for     those subjects with COPD that return to the unit for Visit 2 7-10 days later, in addition to     the screening window of 28 days.   "
56078|NCT02551601|"     The purpose of this study was to determine the subfoveal choroidal thickness in normal Thai     eyes and study the associations with gender, age, refractive error and axial length using     spectral-domain optical coherence tomography with enhanced depth imaging technique.   "
56079|NCT02551588|"     Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the     obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography     Doppler, which assesses two key markers that are aortic valve pressure gradient and the     aortic valve area. however these marker are a poor reflect of the clinical severity of AVS.     The aim of the study is to validate new markers assessing cardiac fibrosis that might best or     complementary markers.   "
56080|NCT02551575|"     This is prospective randomized, controlled study to evaluate the efficacy and safety of     Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis     (RA). The major outcome index is the change from baseline to week 24 in Disease Activity     Score (DAS28), and minor outcome indexes include American College of Rheumatology     (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any     time were recorded to evaluate the safety.   "
56089|NCT02551458|"     Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and     predictive markers of Complete Clinical Response and Pathologic Complete Response (using     blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its     toxicity.      The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT     will thus be chosen by the investigator from published effective schemes in a pre-operative     setting or in patients not undergoing surgery.      Evaluation of the response 5 to 6 weeks after the RCT.      Step 2: Randomisation in patients with a complete clinical response:      Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable     loco-regional recurrence      Patients not eligible for randomisation will have the possibility to participate in a     specific study (information can be obtained from the SAKK group (Switzerland Group Clinical     Research on Cancer)).   "
56081|NCT02551562|"     20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation     treatment, meet all the inclusion and none of the exclusion criteria, and have signed a     written informed consent, will be enrolled. Subjects will be divided randomly into two     treatment groups:        1. Group A: subjects will use a basic skin care regime following a full facial rejuvenation          with hyaluronic acid soft-tissue filler and botulinum neurotoxin.        2. Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with          hyaluronic acid soft-tissue filler and botulinum neurotoxin.      The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit     2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation     (Visit 5).      Changes in the subjects' quality of skin will be determined by the PI's assessment of skin     tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as     well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and     hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects.      Subjects' satisfaction with treatments and their quality of skin will be determined through a     self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The     impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks     following the treatments.   "
56082|NCT02551549|"     A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of     CD101 Injection in Healthy Subjects.   "
56083|NCT02551536|"     Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide     is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor     antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and     methods: Seventy patients with allergic rhinitis participated in a prospective, randomized,     double-blind, parallel, active controlled, comparative 4 week trial. The patients between age     group of 18-65 years of either gender having moderate-severe intermittent or mild persistent     allergic rhinitis were included. The study inclusion criteria required the subjects with     Total Nasal Symptom Score (TNSS) of 5 or higher. The patients were randomly divided into two     treatment groups with montelukast-levocetrizine (10 mg and 5 mg) in one group and     montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main     effectiveness parameter.   "
56084|NCT02551523|"     Long term toxicity of combination antiretroviral therapy (cART) is a substantial contributor     to morbidity and mortality in chronically infected HIV positive individuals. To date it is     still debated, whether long term nucleoside reverse transcriptase inhibitors (NRTI's)     -sparing regimens are practicable or even superior compared to standard of care cART in terms     of efficacy, safety and tolerability. In addition, data about efficacy of integrase inhibitor     (INSTI) based monotherapy is lacking. We aim at investigating the efficacy of standard of     care combination antiretroviral therapy with a simplified dolutegravir monotherapy in     patients with a primary HIV-1 infection under suppressive early standard of care     antiretroviral therapy. Briefly, hundred-thirty-eight patients with a documented primary     HIV1- infection (PHI) will be recruited from the Zurich Primary HIV-1 Infection Study (ZHPI),     which is an open label, non-randomized, observational, single-center study     (http://clinicaltrials.gov, ID 5 NCT00537966). All subjects formerly underwent early cART     consisting of either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase     inhibitor (NNRTI) or a INSTI in combination with two NRTIs at the time point of enrolment in     the ZPHI and must be under a fully suppressive ART (i.e., <50 copies/ml) for at least 48     weeks at the time point of randomisation. The primary end point is the proportion of     individuals with a viral failure at week 48 or before.   "
56087|NCT02551484|"     50 patients will be included for each of the 2 procedures:      - For procedure 1: Patients will be selected during multidisciplinary consultations for     amputees who are stabilized with their definitive prosthesis and have returned to their usual     place of residence. The aim of this procedure is to show the validity and reproducibility of     measurements of tissue oxygenation using NIRS (TcPO2 being the reference measurement), to     determine the way in which NIRS measurements are more precise (i.e. in terms of validity and     reproductibility) (values at rest with the patient lying perfectly flat or with the amputated     limb raised 30°). These patients will require a single visit which will include measurements     by NIRS and TCPO2, a walk test and the completion of 2 questionnaires (visual scale).      - For procedure 2: The patients will be included in the initial phase of postamputation     rehabilitation, during the period of in-hospital rehabilitation. The main problems of healing     and tolerance to the temporary prosthesis arise during this phase. The specific objectives     will be: To show that measurement by NIRS predicts the quality of healing in trans-tibial     amputees; to show that the zone of uncertainty concerning the predictive values for the     viability of the stump is smaller with NIRS than with TcPO2 (better discrimination). NIRS and     TCPO2 measurements as well as the evaluation of stump healing will be done 15, 30 and 45 days     after the amputation.   "
56088|NCT02551471|"     The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15%     are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection     margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The     invasion of the resection margins triples the risk of local recurrence. In the absence of     surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of     rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative     resection. The care and management of locally advanced and fixed rectal tumours and pelvic     recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a     difficult therapeutic problem with great variability in the methods of care and management     around the world. These variations in practice can be explained by structural and     organizational differences, as well as cultural dissimilarities. With regards to the     organization of its healthcare system, Australia is shown to be a leader as regards the care     and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal     cancer.   "
56090|NCT02551445|"     This study involves people with eating disorders and healthy volunteers (people who have     never experienced an eating disorder). Participants are interviewed about their psychological     and physical health by the experimenter and they have a simulated scan session (about 1     hour). Approximately 1 week after they attend the first study session. They are asked to     complete questionnaires and computerized tasks (about 30 minutes) followed by the active scan     (1 hour). During the brain scan they look at pictures and answer questions about the     pictures. After the first study session, people with eating disorders receive an intensive     meal-support intervention (in the following 3 months) aimed at reducing anxiety and fears     related to food (10 sessions lasting about 60 min.). Three months after the first brain scan,     participants with eating disorders and healthy controls receive a second assessment and brain     scan. We hypothesized that the meal support intervention will be effective in: 1) targeting     eating disorder symptoms (body mass index - BMI, primarily) and 2) producing functional     changes in brain regions that underline food-related anxiety and avoidance.   "
56091|NCT02551432|"     Patients with refractory SCLC. Patients will be treated with paclitaxel and pembrolizumab.   "
56092|NCT02551419|"     A six month, placebo-controlled, parallel group project in which MCI participants will     receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo.     Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before     and after the intervention will be assessed by PET (position emission tomography) imaging, as     well as fMRI, diffusion MRI and cognition.   "
56093|NCT02551406|"     Different tools may be used to monitor the efficacy of home mechanical ventilation.     Investigators aimed to compare the prognostic value of the different data obtained by     capno-oxymetry in a mechanical ventilated neuromuscular disease's population.   "
56094|NCT02551393|"     Clinical Trial: The investigators aims at comparing providing validated home BP device,     followed by group education of self-management of hypertension as well as self-BP monitoring     and appropriate medication in response to home BP reading, followed by nurse follow up with     usual care, which may possibly improve older adults with uncontrolled hypertensions drug     adherence, and therefore improve their BP level in primary care setting. The investigators     will invite total 270 patients from 6 general outpatient clinic (GOPCs) to participate the     trial.      Qualitative study: The investigators would also like to evaluate patients' view and     operational concerns on self BP monitoring by individually interviewing 30 selected patients     from intervention group   "
56095|NCT02551380|"     The investigator planned to study the efficiency of folinic acid treatment on autistic     symptoms in children suffering from autism spectrum disorder.   "
56096|NCT02551367|"     110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35     distributed randomly :        -  55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday          of the cycle for three successive cycles.        -  55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to          the 6thday of the cycle for three successive cycles.      Patients will be subjected to:      Complete history taking:        1. Details about name, age        2. Menstrual history with determination of menarche        3. Amenorrhea or oligomenorrhea , Regularity of the cycle        4. History of endocrine disease.        5. History of previous operations.             -  Physical examination:             -  General examination:           With special concern to:           --Acne.           --Hirsutism .           --Weight.           --Height           --BMI was determined :           Wt. in kg ـــــــــــــــــــ =           ) Height in m)2           - Abdominal examination :             -  for scar of previous pelvic or abdominal operations .                  -  Pelvic examination :             -  vaginal examination for enlarged cystic ovaries.                  -  ultrasound for diagnosis of pcos.           PARAMETERS:      (1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number     of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical     pregnancy. (7) ongoing pregnancy   "
56097|NCT02551354|"     Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric     labor and childbirth. It consists in establishing a catheter into the epidural space and to     block the transmission of pain sensations by injecting a local anesthetic and an opioid. In     10-25% of cases the epidural does not give perfect results, causing it to test its     effectiveness, which is mainly done by questioning the patient on mitigation or disappearance     of pain. This collaboration of patients is sometimes limited in our care structure by the     inability to assess or express the pain, mainly due to cultural differences or language     barriers, which can represent up to 15% of women in our institution. This led to develop     objective measures of pain techniques used at the bedside.      Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of     the pupil, and parasympathetic system (pΣ).      The PD increases in response to painful stimulation, in proportion to the intensity of the     nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain     in patients under general anesthesia, but has been little studied in conscious subjects.      There are other permanent changes in the PD, due to constant interaction between Σ and pΣ     systems. Few data have been published to date on this PD variability (PDV).   "
56098|NCT02551341|"     Randomized study investigating the effects of lung protective ventilation (PEEP), as compared     with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water,     vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing     assisted robotic radical prostatectomy   "
56099|NCT02551328|"     The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory     response and platelets function during minimally invasive mitral valve repair or replacement     (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \propofol)   "
56100|NCT02551315|"     This multicenter, prospective, observational cohort study will assess bone differences in     women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.   "
56101|NCT02551302|"     Effectiveness of hybrid systems (topping off) compared to rigid spondylodesis in fusion     surgery of the lumbar spine: A prospective, randomized, bicentric pilot study (CD HORIZON     BalanC™)   "
56113|NCT02551146|"     The aim of this study is to assess the influence of this particular treatment method on the     patients' quality of life and masticatory function.   "
56102|NCT02551289|"     One in 100 people suffers from coeliac disease. It affects the lining of the bowel and causes     many symptoms such as diarrhoea, wind, stomach pain, constipation and nausea. The only     treatment so far is a strict glutenfree diet for life which reverses the bowel damage and     often improves symptoms. Up to 25% of patients however may have persistent symptoms despite     the gluten free diet but the reasons for this are not clear.      This research aims to help us understand how the gluten free diet works. Investigators will     use medical imaging (magnetic resonance imaging or MRI) to measure the volumes of fluid in     the small bowel, the size of the large bowel and the time it takes for foods to go through     the entire bowel in patients who have just been diagnosed with coeliac disease by their     hospital doctor. Investigators will also carry out a breath test and collect a stool sample     for basic analysis of the stool bacteria.      Investigators will also collect questionnaires about their feelings and their bowel habits     and will try to see how the MRI measurements relate to the patients' symptoms. Investigators     will observe how all these measures change after one year of the gluten free diet that     doctors will have prescribed as part of the coeliac patients' standard care. As such there is     no dietary intervention in this study, investigators will simply study changes in the     patients due to their standard treatment. Investigators will also look at a matched group of     healthy volunteers to gather a likely reference range of the measurements. This research will     be carried out in Nottingham with the help of the specialist coeliac clinics and it will last     3 years. There is a dedicated Coeliac Patient Public Involvement group who have helped plan     this study.   "
56103|NCT02551276|"     Studies in animals have shown that beta2-adrenoceptor activation with selective agonists     regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These     effects may be mediated by cAMP/PKA dependent activation of several downstream sites that     modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is     well-described in animals, it is inadequately explored in humans. The purpose of the study is     thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling)     on muscle hypertrophy.   "
56104|NCT02551263|"     This is a observational study in a real-world setting, not requiring determining a dosage     regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose     of the study is to investigate the efficacy of eribulin as the first or second line     chemotherapy to prolong overall survival and to explore factors affecting the survival in     patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast     cancer who scheduled to receive the first or second line chemotherapy in clinical practice in     Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year     enrollment period and 3-year observational period; the duration of patient participation will     be 3 years. All patients will receive adequate treatment for breast cancer which selected by     the primary physician after enrollment using the Japanese Breast Cancer Society Clinical     Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN)     Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will     enter patient data into an electronic data capture (EDC) system up to the third chemotherapy     in the study. The end of the study is defined as the time the last patient completes     observational period. Patients will primarily be assessed by overall survival (OS) of the     first line chemotherapy.   "
56105|NCT02551250|"     The investigators will investigate the usefulness of biannual ultrasonography versus annual     non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in     single arm patients.   "
56106|NCT02551237|"     The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine)     to a short course RT associated with a delayed surgery, with two primary objectives: the     efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).   "
56107|NCT02551224|"     The purpose of this study is to compare in COPD patients naïve to DPIs, the perception of the     Breezhaler® and Ellipta® devices' feedback mechanisms evaluated using a preference     questionnaire.   "
56108|NCT02551211|"     With the recent approval of Nivolumab for second-line treatment of stage IIIb/IV non-small     cell lung cancer (NSCLC), immune checkpoint inhibitors are entering the standard of care for     lung cancer. Other immune checkpoint inhibitors are under evaluation, both in resectable and     non-resectable NSCLC. In order to refine our use of these molecules, comprehensive data on     the immune contexture of NSCLC are needed. Moreover,a blood marker of this contexture would     allow physicians to monitor the immune status of their patient's tumor and though to evaluate     the rightful place of immunotherapy in the multimodal treatment of NSCLC. No such blood     marker has been validated so far. The LYMPHOLUNG study investigate the concordance between     blood and intratumoral counts of immune cells in resectable stage I to IIIA NSCLC. By the use     of 30-marker cytometry, a precise immune profile of NSCLC will be depicted. The prognostic     value of the circulating and intra-tumoral T regulator over total lymphocytes ratio for     2-year recurrence-free survival will also be addressed.   "
56109|NCT02551198|"     Colonoscopy is considered by many the preferred mode of screening for colorectal cancer     (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate     bowel preparation.      For bowel preparation, effective, well-tolerated and safe methods should be applied.      Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of     direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate     solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned     the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel     preparation   "
56110|NCT02551185|"     This is a Phase 1b, multicenter, single arm, open label, dose escalation study to determine     the MTD and evaluate the safety and preliminary antitumor activity of orally (PO)     administered ACY 241 in combination with intravenously (IV) administered paclitaxel in     eligible patients with advanced solid tumors.   "
56111|NCT02551172|"     To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic     patients with high risk for CHD.   "
56112|NCT02551159|"     This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine     the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus     SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior     systemic chemotherapy for recurrent or metastatic disease.   "
56115|NCT02551120|"     Hypoparathyroidism (hypoPT) and pseudohypoparathyroidism (Ps-hypoPT) are rare diseases,     characterized by low levels of parathyroid hormone [PTH] and plasma calcium or high plasma     PTH and low plasma calcium, respectively. A recently study by the investigators' group,     identified 123 living persons with idiopathic hypoPT and 62 living persons with Ps-hypoPT,     only few of these have been genetic tested.      The aim of the study is to perform a detailed clinical and genetic characterization of Danish     patients with idiopathic hypoPT and Ps-hypoPT. Patients will be examined by questionnaires,     biochemistry, scans, bone biopsies and genetic tests. Furthermore the investigators aim to     perform family tracing for the hereditary forms. The prevalence of magnesium depletion will     be assessed as well.      In addition to providing new information on symptoms, co-morbidity, and prognosis for this     group of patients, the investigators presume that the study may improve their understanding     on calcium homeostasis and bone metabolism in general.   "
56116|NCT02551107|"     This pilot study aims to measure nasal nitric oxide (nNO) in a group of neonates and infants     (≤ 12 months) with congenital heart disease (CHD) and compare their nNO levels to age matched     controls without CHD. CHD patients will be divided into subgroups, based on their cardiac     anatomy, to try and identify a level of risk of ciliary dyskinesia within the subgroup of     CHD. Each of these sub groups' nNO levels will be compared between groups and against age     matched control infants without CHD.   "
56117|NCT02551094|"     The study evaluates whether long-term treatment with colchicine reduces rates of     cardiovascular events in patients after myocardial infarction. Patients who have suffered a     documented acute myocardial infarction within the last 30 days, are treated according to the     national guidelines and after having completed any planned percutaneous revascularization     procedures associated with their initial infarction will receive either colchicine (0.5 mg     per day) or matching placebo (1:1 allocation ratio) for an estimated 2 years period or until     the target of 301 primary endpoints has been reached.   "
56118|NCT02551081|"     The purpose of study is to evaluate the benefits of using the Next Generation Sequencing     Technology to diagnose birth defects and genetic diseases. The results from genomic     sequencing can also significantly shorten the time of examination, improve the diagnosis     rate, guide the clinical treatments. So the ultimate goal is individualized or personalized     therapy and promote prognosis.   "
56119|NCT02551068|"     The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking     nintedanib will have improved exercise endurance, breathlessness and quality of life if     breathing 60% oxygen compared to standard of care during an 8 week exercise training program.   "
56120|NCT02551055|"     The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Part     2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel, paclitaxel,     investigational TAK-659 or investigational alisertib in adult participants with advanced and     metastatic gastric or gastroesophageal adenocarcinoma. The study consists of a dose     escalation phase (Part 1) and a dose expansion phase (Part 2).   "
56121|NCT02551042|"     Many patients with Scleroderma (Systemic sclerosis) experience damage to blood vessels,     mainly to the small arteries. A common manifestation of this is Raynaud's phenomenon (fingers     or toes turning white then blue in the cold) and digital ulcers (open sores on the     fingertips). The purpose of this study is to see how effective the study drug Human Factor     XIII Concentrate is in treating patients who have these and other common manifestation of     Scleroderma. It will be given in addition to the accepted treatments used for this disease.   "
56122|NCT02551029|"     Brain imaging has shown abnormal brain activations in response to visceral stimulation in     patients with the Irritable Bowel Syndrome (IBS). To investigate the possible role of the     Nucleus of the Solitary Tract (NTS), the primary relay station in the brainstem for vagal     afferents, its activation in IBS and functional dyspepsia patients will be evaluated. Prior     to this, an exploratory study in healthy volunteers will be conducted. This will be the first     high magnetic field fMRI study evaluating the possible role of NTS activation in visceral     abdominal pain. Moreover, this will be the first fMRI study using duodenal capsaicin infusion     as a chemical stimulus, which is more physiological than mechano-stimulation.   "
56123|NCT02551016|"     The main objectives of this study are i) to assess how heart failure was captured accross     different linked electronic health record sources within the CALIBER program and the overlap     between primary care, hospital admissions and/or the national mortality register, and ii) to     assess risk factors, heart failure treatment and survival in patients, stratified by EHR     source.   "
56124|NCT02551003|"     This study examines the effect of cord blood in the treatment of newborn infants with     neonatal encephalopathy in combination with hypothermia, which is the standard treatment for     this condition. The hypothesis is that the cord blood + hypothermia combination will produce     better neuroprotection than the standard treatment of hypothermia alone.   "
56125|NCT02550990|"     The purpose of this study is to determine the treatment effects of sequential combination of     aerobic exercise and cognitive training on cognitive function, physiological markers, daily     function, physical function, social participation and quality of life in stroke patients with     cognitive decline. The investigators hypothesized that: (1) sequential training protocol can     improve outcome measures compared to single mode of training; (2) these treatment effects     will retain at 6-month follow-up.   "
56126|NCT02550977|"     The purpose of this study is to look into the effectiveness of a new investigational     medication applied as a transdermal patch. The patch is applied on the skin with study     medication that is absorbed through the skin suppressing ovarian activity and therefore     preventing an egg from leaving an ovary (ovulation). The study will look into the study     drug`s safety and how well it is tolerated and its absorption, breakdown and elimination in     the body. It describes how the body affects a specific drug after administration.   "
56127|NCT02550964|"     The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy     who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as     rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the     investigators will screen these patients by baseline examination (Fundus photography, fundus     autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test     and multifocal electroretinography) and observe with same examination for every year.   "
56133|NCT02550886|"     In 2011, 38.6 million hospital stays occurred in the United States at a cost of $387.2     billion. 47.9 percent involved hospitalizations during which surgical procedures were     performed. Orthopedic procedures constituted the most frequently performed and most costly of     operating room procedures. As the healthcare climate in the United States continues to     change, there is a trend towards providing effective care in a fiscally conservative manner.     Central to this strategy is the shift towards increasing ambulatory surgical procedures from     surgeries requiring post-operative admission for patients. While savings to hospitals and     third-party payers are implied, there may be an unrecognized increase in financial, physical,     and psychosocial post-operative costs to patients undergoing ambulatory surgery and to their     caregivers. Rawal et al., and McGarth and colleagues have found that patients undergoing     orthopedic procedures had moderate to severe post-operative pain. We propose to present a     survey to patients and their caregivers before surgery and at multiple timepoints     post-operatively to acquire information on the impacts of ambulatory orthopedic surgery. In     addition to assessing post-operative pain, this study serves to examine various other     possible burdens to patients that have not been previously evaluated in this patient     population.      REFERENCES      McGarth B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have a     moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J     Anesth. 2004; 51:886-891.      Rawal N, Hylander J, Nydahl P, Olofsson I, Gupta A. Survey of postoperative analgesia     following ambulatory surgery. Acta Anesthesiol Scand. 1997; 41:1017-1022.   "
56134|NCT02550873|"     This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed     to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with     IPF.   "
56135|NCT02550860|"     The epidermal barrier efficacy is determined by the physicochemical properties of the     epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role.     Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving     lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier     through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many     applications in clinical nutrition, mainly limiting water loss in patients receiving     long-term LCPN and help in electrolyte and water balance.      The objective of this interventional clinical trial is to evaluate the epidermal barrier     function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean     oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal     barrier function will be assessed through the transepidermal water loss (TEWL) measurement on     the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE     (SO-based or FO-containing) will be compared using a randomized double blind crossover     design, using patients as their own control. Each IVFE will be allocated for a 3-month     period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and     red blood cell EFA profile will be determinate in order to facilitate result interpretation.   "
56136|NCT02550847|"     The aim of this study was to evaluate MR/PET with both functional and molecular imaging on     the prediction of prognosis in patients with suspected pancreatic cancer.   "
56137|NCT02550834|"     This study investigates if, patients with diagnosed chronic spinal cord injury will benefit     from an Indoor Curling Exercise program on their control capabilities of trunk movements and     on their intrinsic motivation for physical activity. Half of participants will receive 8     training-sessions during 4 weeks, while the other will receive usual care.   "
56138|NCT02550821|"     The purpose of this study is to compare physical activity levels between patients with     bronchiectasis and healthy subjects.      We hypothesize that patients with bronchiectasis will have lower levels of physical activity,     since physical activity levels is affected by reduced exercise tolerance, severity of disease     and other disease related symptoms and conditions.   "
56139|NCT02550808|"     This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic     cardiopulmonary disease. The investigators will also investigate metabolic disorders like     glucose metabolism, presence of metabolic syndrome, body composition and histological changes     in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.   "
56140|NCT02550795|"     Previous reports demonstrated that dexmedetomidine could reduce the incidence of     postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for     ajuvant drugs for preventing and reducing PONV. So investigator want to study about the     effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.   "
56141|NCT02550782|"     Infraclavicular block is one of the peripheral nerve block used in upper extremity surgery.     Adjuvant agents are used in peripheral nerve blocks to increase the duration and block     quality. We investigated that the effects of patient-controlled perineural dexmedetomidine     application on postoperative analgesia.   "
56142|NCT02550769|"     INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less     invasive procedure that responds to some of the limitations of the rectal laparoscopic     approach.      MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion     rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with     the same pathological, functional and oncologic results.      METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal     cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general     morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The     sample calculation is 58 patients per group.   "
56143|NCT02550756|"     The purpose of this study is to confirm that the local anesthetic applied to subjects with     Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure     discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b     study.   "
56144|NCT02550743|"     The primary goal of this Brown University Oncology Research Group is to determine that a safe     dose of BYL719 can be administered with capecitabine and radiation in patients with rectal     cancer. Therefore, the threshold of success for this phase I study is to establish safety.   "
56347|NCT02548091|"     The purpose of this study is to determine whether Non Invasive Ventilation are effective in     prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis     is that administration of Non Invasive Ventilation during the procedure and systematically in     post procedure period is a protective factor against the development and severity of     reperfusion pulmonary edema.   "
56145|NCT02550730|"     Peer support during labor, birth and the perinatal period (also known as doula support) has     been shown in some studies to reduce cesarean rates, postpartum depression and increase     breastfeeding rates. The purpose of this program evaluation is to prospectively assess the     clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the     few established, hospital-based programs in the United States. To enhance the capability of     the Birth Sisters Program to impact social determinants of perinatal health in a low-income     population, the program evaluation will include the addition of Medical Legal Partnership for     Children's (MLP) training and referral services. This program will be described as the Birth     Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB     compared with no Birth Sister support for women receiving maternity care at Boston Medical     Center. Eligible women will be randomly assigned either BBB services or usual care. All women     will be consented and interviewed in the mid-second trimester of pregnancy and interviewed     again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8 prenatal Birth     Sister visits in the home or at Boston Medical Center starting at 6 months of pregnancy,     continuous support through labor and birth, and up to 4 postpartum Birth Sister visits in the     home or at Boston Medical Center. The usual care group will receive no birth sister support     but does have access to standard interdisciplinary maternity care services. The primary     outcomes will be reduction in cesarean rate. Secondary outcomes will include cost, labor     interventions, infant outcomes, satisfaction with care and psychosocial outcomes, including     depression, social functioning and self-efficacy.   "
56146|NCT02550717|"     To investigate the risk of major bleeding (including gastrointestinal and intracranial     bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical     practice   "
56147|NCT02550704|"     Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are     three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion     between these abnormalities is not known. We hypothesis there is a link between them in IBS     with diarrhoea.   "
56149|NCT02550678|"     The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal     cell carcinoma (nBCC) in patients aged 18 years or over.      The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU     for 3 weeks and undergo surgical excision of the tumor.   "
56150|NCT02550665|"     This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg     for patients with Alzheimer's disease. Investigators randomly divide participants into three     groups according to the dose escalation method; no titration, 15mg of donepezil for a month     before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to     23mg.   "
56151|NCT02550652|"     This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate     mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with     proliferative LN.   "
56152|NCT02550639|"     The aim of this prospective, randomized study is to assess a subject's immunological status     against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT     technique confirming previous results and establishing their statistical validity in order to     determine whether this test could be used routinely in clinical practice to assess the risk     of developing hCMV infection after renal transplantation and, ultimately, identify the most     effective individual antiviral therapeutic strategy against hCMV.   "
56153|NCT02550626|"     Hypothesis is that the presence of a-synucleinopathy related non motor symptoms could be     predictive factor for post-operative delirium. During 72hrs after spine surgery, investigator     will observe occurrence of post-operative delirium, and analysis difference of     a-synucleinopathy related non motor symptoms between 2 groups.   "
56154|NCT02550613|"     The purpose of this study is to explore the ability of integrated MRI/PET to detect and     evaluate treatment outcome in HCC patients.   "
56191|NCT02550132|"     The objective of the present study is to determine if spinal manipulations with a constant     rate of force application but with different peak force and time to peak force lead to     similar responses in healthy adults.   "
56155|NCT02550600|"     The purpose of this study is to compare the effect of interventional Lung Assist iLA activve     to standard therapy in mechanically ventilated patients with severe acute lung impairment.     Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or     death) within 28 days compared to standard treatment.   "
56156|NCT02550587|"     The level of patient satisfaction is an important indicator of health care quality because it     causes to reconsider the functioning of the hospital and go to the new regulations.     Postoperative thought gives us important information for improving the quality of anesthesia     care and health care quality. The investigators aimed to investigate the status of the     anesthesia satisfaction in patients.   "
56157|NCT02550574|"     The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during     repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis     compared to wound closure with sutures.   "
56365|NCT02547857|"     Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for     ovarian pathology, though its use has not been described in the medical literature. This     observational study aims to describe its use in clinical ED practice.   "
56158|NCT02550561|"     In 2014, the American Urological Association updated it management algorithm for Interstitial     Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become     increasingly invasive and morbid. 4th line treatment is sacral neuromodulation (SNM),     involving a two stage surgical procedure and permanent device implantation. While the     mechanism for decrease in IC/PBS symptoms is unknown, SNM is thought act through central and     peripheral mechanisms related to afferent signaling, causing modification of pain and lower     urinary tract sensation.¹      Percutaneous posterior tibial nerve stimulation (PTNS) is a method of peripheral     neuromodulation targeting the same nerve roots as SNM, but with significantly fewer risks.     The purpose of our research is to determine if PTNS is effective in the treatment of IC/PBS.     The results of this study will suggest future directions and provide critical information to     design studies to determine to what extent and in what situations PTNS may be effective.      The investigators will enroll subjects with IC/PBS and urinary frequency/urgency to treatment     with 12 weekly treatments of PTNS. The investigators will assess symptoms and lower urinary     tract function before, during and after the treatments. At the completion of treatments,     subjects will be asked to enroll in post-study follow up monitoring to understand the     duration of symptom effect.   "
56159|NCT02550548|"     This project is designed to advance understanding of the incretin effect in health and     disease. This system of gut-islet linkage is essential for normal glucose tolerance, impaired     in T2DM, and amenable to therapeutic intervention. However, there are important gaps in     understanding incretin function that limit application of this system; this project will     address several of these. A secondary, but critical aspect of this research is focus on     inter-individual variation in the physiology of the incretin system. This is a novel     direction for research in this field and is critical to advancing the concept of     individualized medical care in diabetes by establishing whether there is a physiologic basis     for predicting the existence of responders and non-responders to incretin therapies.      Currently, we have described only Aim 1 from this grant in this protocol registration. While     Aim 2 and 3 are described in the grant, Aim 1 will be conducted first and the results from     this Aim and / or the publication of other results in the field may affect the approach to     Aims 2 and 3.   "
56160|NCT02550535|"     This is a Phase I/II trial to determine safety, clinical efficacy and feasibility of a     gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) and acute     myeloid leukaemia (AML).      Patient's white blood cells (T cells) will be modified by transferring a gene which enables     them to make a new T cell receptor (TCR) that can recognize fragments of a protein called WT1     (Wilms' tumour 1) which is present at abnormally high levels on the surface of     myelodysplastic and leukaemic cells.      In this trial, approximately 25 participants with an Human Leukocyte Antigen A2 (HLA-A*0201)     tissue type who have failed to achieve or maintain an IWG defined response following     hypomethylating agent therapy will be recruited.   "
56161|NCT02550522|"     The BCI project falls within the very broad field of brain machine interfaces. Its multiple     applications include the compensation of motor deficits. The subject of the present protocol     is the first test of the system in man on the compensation of motor deficits by an epidural     brain implant enabling an electrocorticogram (EcoG) to be recorded.   "
56162|NCT02550509|"     Muscle alterations and modifications passive biomechanical properties that occur on a spastic     muscle contribute to functional disorders involved in spasticity. Botulinum toxin (TB) A is     the reference treatment of the focused spasticity, and muscle source structural and     biomechanical changes, very little studied in humans, especially since it is not one     possibility of easily and reliably paraclinical assessment injections consequences.   "
56163|NCT02550496|"     Waiting for a proof by mycological culture is usually necessary before starting a systemic     antifungal therapy. It therefore seems to us interesting to evaluate the benefit of using     dermoscopy in clinical diagnosis of Tinea Capitis.   "
56164|NCT02550483|"     The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants     will start with a 2-week free-living wash-in period where they will be asked to avoid certain     carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In addition to     the controlled diet, participants will consume one of three beverages (300 mL/day; n =     12/group): placebo beverage (control), high beta-carotene tomato juice, and high-lycopene     tomato juice. Blood, urine and feces will be collected throughout the study.   "
56165|NCT02550470|"     This is a prospective, randomized, double blind study investigating the duration of use and     cost of the new CO2 absorbent Micropore's Spiralith®, compared to Drägersorb® 800+,     Drägersorb® Free.   "
56166|NCT02550457|"     This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back     pain. All the subjects will be submitted to an evaluation of the painful sensation,     functional performance, trunk range of motion and neuromuscular performance at three     different times.   "
56167|NCT02550444|"     The purpose of this study is to evaluate effects of intravenous clonidine in acute and     chronic post-cesarean pain, possible adverse effects over mother-newborn pair, in comparison     to intrathecal adjuvant clonidine and placebo.   "
56193|NCT02550106|"     Evaluate the proportion of patients with an urticaria control test [UCT] score of greater     than or equal to 12 at Week 12.   "
56170|NCT02550405|"     This project aims to (1) investigate behavioral and neural factors (e.g., emotional factors     such as craving and cognitive factors such as decision-making)) associated with Internet     addiction (mainly Internet gaming disorder ;IGD); (2) develop an tailored intervention (named     craving behavioral intervention; CBI) for IGD based previous evidence; (3) evaluate the     behavioral and neural effects of CBI on individuals with IGD. This project in implemented in     Beijing, China, based on a relatively large sample of young adults with IGD. It will advance     the investigators' understanding of the characters associated with IGD and the mechanisms     underlying the psychological-based interventions in the field of IGD, as well as other     addictive disorder. Moreover, this study will also shed new light on the development of more     effective interventions.   "
89797|NCT02110732|"     The purpose of this study is to evaluate the effect of oral administration of probiotic     Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.   "
56171|NCT02550392|"     Transient Ischaemic Attack (TIA), also called 'ministroke' is characterised by shortlasting     symptoms that generally do not cause permanent damage. 'Minor stroke' is a term used to     describe a stroke with mild and nondisabling symptoms. TIA and minor stroke patients account     for more than half of all cases of stroke and they are at a higher risk to suffer a major     stroke. Currently, management of TIA/minor stroke patients is mainly focused on identifying     and reducing risk factors for a later stroke. However, people after a TIA often have limited     access for further specialist support from stroke-specific rehabilitation services. Although     there is variability in the level of recovery and severity of symptoms after TIA and minor     stroke, there is evidence that these patients may experience difficulties that affect their     quality of life including anxiety and depression.      This study aims to develop, tailor and target the delivery of a time-limited group     intervention that offers educational, psychological and social support for people following     TIA and minor stroke. A qualitative study (Phase 1) will be conducted with service users and     experts working with people with TIA/minor stroke to develop the psychoeducational     intervention. Following this, we will conduct a feasibility randomised controlled trial in     one centre (Phase 2) to explore whether this group psychoeducational intervention for people     after TIA and minor stroke carers is acceptable and to determine the feasibility of the     proposed evaluation and the sample size needed in a definite trial.   "
56172|NCT02550379|"     While it has been hypothesised that individuals who experience social anxiety are more likely     to misread facial emotions as threatening or disapproving, researchers have proposed that the     difficulty may lie in decoding ambiguous facial expressions rather than identifying emotions     which are expressed with greater intensity. Emotion recognition (ER) training provides a     promising new avenue of research which may be beneficial in altering emotion processing     biases which maintain or increase symptoms of mental health disorders. This study will     examine the effectiveness of ER training in a community-based sample of young people (15-18     years) who report high levels of social anxiety. The intervention aims to alter emotion     processing biases through a training procedure designed to promote the perception of     happiness over disgust in ambiguous facial expressions which we hypothesise will subsequently     reduce symptoms of social anxiety.      The study design consists of two phases. During Phase 1 participants will complete a     screening questionnaire. This questionnaire will include a measure of the affective,     cognitive, and behavioural components of social anxiety in adolescence. Depending on their     suitability (i.e. scoring above a cut-off on a standardised measure of social anxiety in     Phase 1 of the study), participants may then be invited to take part in a 4-day     computer-based emotion recognition training programme (Phase 2). The purpose of this phase is     to see if ER training will help young people feel less worried or nervous in social     situations by training them to interpret ambiguous facial expressions as expressing a     positive emotion (happy rather than disgusted).      Participants will be randomly assigned to either the intervention or placebo (inactive)     group. Both groups will be asked to complete a 4-day programme involving one computer     training session per day (each session takes approximately 20 minutes). Questionnaires will     also be given to participants to complete before and after the intervention, along with a     2-week follow-up assessment. These will include questionnaires to measure social anxiety,     depressive symptoms, and fear of negative evaluation. Each questionnaire will take     approximately 15 minutes to complete. Participants will not know whether they have received     the intervention or placebo training until after the intervention.   "
56173|NCT02550366|"     Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI     is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used     in the diagnosis of CAD. In this work, the investigators will develop and validate techniques     for accelerated cardiac MRI, offering better volumetric coverage of the heart, improved     contrast, and superior spatial and temporal resolutions.   "
56174|NCT02550353|"     The aim is to evaluate the short-term changes in ocular surface measures and tear     inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser     in situ keratomileusis (FS-LASIK) procedures.   "
56175|NCT02550340|"     The study aims to determine if acute recreational alcohol intake is associated with the     occurence of ECG changes and arrhythmias.   "
56176|NCT02550327|"     The objective of this study is to improve survival by the addition of anakinra to the     chemotherapy combination of nab-paclitaxel, gemcitabine, and cisplatin in patients with     resectable or potentially resectable pancreatic adenocarcinoma (PDAC). The primary endpoint     of the study is to determine whether the combination of abraxane, gemcitabine, cisplatin, and     anakinra will improve disease-free survival (DFS) and to determine the number of patients who     meet or surpass 11.5 months of DFS.      The secondary objectives of this study are to evaluate the effect of anakinra when combined     with the three-drug regimen of nab-paclitaxel, gemcitabine, and cisplatin on response rate     and overall survival after diagnosis and adverse events of patients with resectable or     potentially resectable PDAC. The investigators will use the benchmark of 24 months overall     survival (OS) to determine how many patients meet or exceed this goal. The investigators will     monitor, by survey, patients' health related quality of life while on treatment to determine     if the addition of anakinra improves this measure.   "
56177|NCT02550314|"     To assess the efficacy and safety of the regeneration treatment of tympanic membrane with     NPC-18 and FBG-18.   "
56178|NCT02550301|"     Platelets play a major role in thrombus formation and platelet size, measured by Mean     Platelet Volume (MPV) correlates with platelet activity. MPV is increased in patients with     Myocardial Infarction (MI) and is an independent predictor of adverse events in patients with     ST Elevation Myocardial Infarction (STEMI) . Data on MPV in patients with stable angina is     limited.      Aspirin and clopidogrel are antiplatelet agents administered routinely to patients undergoing     PCI and are required for stent patency. MPV is not known to be affected by low dose Aspirin.     Treatment with clopidogrel is thought to reduce MPV in-vitro but the magnitude of this     reduction in MPV is unclear, especially in patients with stable angina undergoing PCI. An     inverse correlation also exists between MPV and platelet count .      The investigators aim to assess if a change occurs in MPV (∆ MPV) after routine clopidogrel     administration in patients with stable angina undergoing PCI.   "
56179|NCT02550288|"     This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10     mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg     alone when administered to Japanese participants with hypercholesterolemia. The primary     hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior     to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is     superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein     cholesterol (LDL-C) after 12 weeks of treatment.   "
56192|NCT02550119|"     This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without     aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing     chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent     nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving     aprepitant together with dolasetron mesylate and dexamethasone is more effective than     dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.   "
56180|NCT02550275|"     Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by     movement disorders, cognitive and behavioral. The social behavior of patients are changed,     affecting interpersonal relationships. Patients with Huntington's disease are described as     self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral     problems can be a major source of anxiety for patients and their families. These disorders     also have a negative impact cognitive and motor symptoms as well as the functional abilities     and the quality of life of patients and their entourage. Authors have suggested that these     problems could be related inter alia to social cognition disorders. This concept refers to a     set of skills and emotional and social experiences that regulate relations between     individuals and can explain the behavior of individuals and groups. The objective is to     evaluate disorders of social cognition, which may account for behavioral changes in     Huntington's disease.   "
56181|NCT02550262|"     Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with     a pump that could only provide continuous infusion of the freezing medication in combination     of pushes of medication activated by the patient, a technique called patient controlled     epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this     continuous infusion of medication is not as effective as previously thought, and suggested     that instead of continuous infusion, intermittent programmed pushes should be used. The     investigators now have devices that are able to do that. Programmed intermittent epidural     bolus (PIEB) is a new technological advance based on the concept that boluses of freezing     medication in the epidural space are superior to continuous epidural infusion (CEI). The new     pumps are able to deliver bolus of medication at regular intervals (PIEB), in addition to     what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in     this manner can prolong the duration of analgesia, diminish motor block, lower the incidence     of breakthrough pain, improve maternal satisfaction and decrease local anesthetic     consumption. Based on the information already available in the literature, this study aims to     determine the best regimen of PIEB achievable with our standard epidural mixture.      The hypothesis of this study is that there is an optimal interval time between PIEB boluses     of 30 to 60 minutes at a fixed volume of 10 ml of our standard epidural mixture that will     provide women the necessary drug requirements, thus avoiding breakthrough pain and need for     PCEA or physician intervention.   "
56182|NCT02550249|"     Neoadjuvant nivolumab will be administered to patients with primary and recurrent     glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery.   "
56183|NCT02550236|"     The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective     longitudinal population-based study with a life course approach to health and disease.      The LIFE Child Study focuses on two main research objectives:        -  monitoring of normal growth, development and health        -  non-communicable diseases such as childhood obesity and its co-morbidities, atopy and          mental health problems      Detailed assessments will be conducted alongside long-term storage of biological samples in     2,000 pregnant women and more than 10,000 children and their families.   "
56184|NCT02550223|"     Comparing an novel technique ( oblique view) during ultrasound guided radial artery     catheterization versus Transverse and longitudinal views   "
56185|NCT02550210|"     In this study, the investigators will enroll women with palpable cancers to assess the     accuracy of the Breast Cancer Locator (BCL) and concomitant procedure as a vehicle to     optimize and validate the approach in surgical cases where the new device will not     substantially alter or modify the standard-of-care procedure before initiating an evaluative     trial of the BCL in non palpable breast cancer cases.   "
56186|NCT02550197|"     The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza     vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern     Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the     Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.      Objectives:        -  To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016          seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH          2015-2016 formulation, with the requirements of the Committee for Medicinal Products for          Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.        -  To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016          seasonal formulations   "
56187|NCT02550184|"     Aim To investigate if the proportion of correctly diagnosed patients at 4 hours after arrival     to the Emergency Department (ED) increases when patients are diagnosed with standard     diagnostics and focused ultrasonography examination (f-US) compared to standard diagnostics     alone.      Methods The investigators are medical doctors who work in the ED and who use f-US as a     diagnostic tool. The patients are those arriving to the ED with symptoms of difficulties of     respiration.      All patients receive a f-US but only in the intervention group these results will be     unblinded to the treating physician once he has made his 1. presumptive diagnosis . A final     presumptive diagnosis has to be made within 4 hours from the patient´s admittance to the ED.      The correct diagnosis is assessed by a blinded audit of the medical journal. This project     holds the potential to develop evidence-based optimization of early diagnostic accuracy.   "
90350|NCT02103452|"     Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non     endometriotic ovarian and endometrial tissues.   "
56194|NCT02550093|"     Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The     vast majority of basic science studies suggested a large effect of oxytocin in minimizing     acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and     pain in humans. Since addictive properties of oxytocin have not been described, the drug may     have important application in the management of acute and chronic pain. No studies have     examined the effect of intranasal oxytocin on pain sensitivity and threshold.   "
56195|NCT02550080|"     This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of     dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Those     patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin     diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need     dapsone administration. The study has two (co-primary) objectives: i) to determine if     screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence of     clinically-suspected DHS versus current standard of care (no genetic screening) and ii) to     determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a     significantly lower incidence of immunologically-confirmed DHS versus current standard of     care (no genetic screening or patch testing). The study consists of up to a 5-day screening     period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing     a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch test (EPT)     assessment period. Eligible subjects will be randomised to one of two study arms: a Current     Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm     (prospective genetic screening: Case). Subjects identified as HLA-B*1301 positive in the     prospective Genetic Screening Arm will not receive dapsone and will be excluded from further     study. Subjects who experience suspected DHS during the 6-week observation would be withdrawn     from dapsone and undergo EPT patch testing 6 weeks later.   "
56196|NCT02550067|"     The ECHO Study is an open-label randomized clinical trial that will compare three highly     effective, reversible methods of contraception (including a non-hormonal method) to evaluate     whether there is a link between use of any of these methods and increased risk of acquiring     HIV infection. A randomized clinical trial among about 7,800 women in four countries, ECHO     will deliver evidence to support and guide individual, policy and programmatic decisions on     contraception for women at risk of acquiring HIV infection.   "
56197|NCT02550054|"     The main goal of this trial is to investigate whether early administration of human     erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months     corrected age. This study is designed as randomized, double-masked, placebo controlled     multicenter study involving at least 312 patients.   "
56198|NCT02550041|"     The study aims to asses the ability of cell tests based on the analysis of the     anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic     fibrosis.      In addition, the study will evaluate the contribution of biological classification of     aspergillosis according to criteria recently proposed by Baxter et al. compared to the     classification used in clinical practice in the hospital of Montpellier.   "
56199|NCT02550028|"     Current treatments for the brain damaging complication of neonatal seizures are     unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral     Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The     purpose of this study is to determine the correct oral dosing, safety and efficacy for oral     Levetiracetam as first line treatment in term new born babies with seizures.   "
56200|NCT02550015|"     The purpose of this study is to examine if high intensity interval training after stroke is     more effective than standard care to increase maximal oxygen uptake, reduce known risk     factors for recurrent stroke and improve function.   "
56201|NCT02550002|"     The primary objective of this study is to test non-inferiority of aflibercept treat and     extend using a relaxed retinal fluid management relative to aflibercept treat and extend     using a strict retinal fluid management SD-OCT (spectral domain optical coherence tomography)     disease activity guided retreatment with respect to best-corrected visual acuity (BCVA) from     baseline to end of treatment.   "
56202|NCT02549989|"     The purpose of this study is to determine the effectiveness of LY3023414 in treating the     participants type of cancer and to determine the types and severity of side effects caused by     treatment with LY3023414.   "
56203|NCT02549976|"     The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in     the GETAID centers included in the RAPID study. Secondary objective is to identify predictive     factors of the evolution digestive damage.   "
56204|NCT02549963|"     This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left     atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular     atrial fibrillation.   "
56205|NCT02549950|"     The purpose of this study is to provide evidence on the effectiveness, the efficiency and     efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing     orthodontic treatment time.   "
56206|NCT02549937|"     Primary Objective:      To evaluate the safety and tolerability of sulfatinib in patients with advanced solid tumors     and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D).      Secondary Objective： To evaluate the pharmacokinetic profile of multiple dose sulfatinib in     patients with advanced solid tumors and to evaluate the anti cancer activity of sulfatinib in     patients with advanced solid tumors.   "
56207|NCT02549924|"     Type 2 diabetes mellitus [ T2DM ] has quickly become the epidemic of the XXI century and     challenging global health . Estimates of the World Health Organization [ WHO ] indicate that     globally , from 1995 to date has nearly tripled the number of people living with diabetes     mellitus [DM ]. Resveratrol has been extensively studied as a regulator of glucose through     its antioxidant effects and protecting pancreatic β cells by activation of sirtuin -1 [ SIRT1     ] dependent deacetylase nicotinamide adenine diphosphate [ NAD ]. Therefore, it is important     to know the effect of resveratrol on the glycemic variability [GV ] in patients with T2DM who     are not in control with metformin monotherapy based.   "
56208|NCT02549911|"     Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy     for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.   "
91099|NCT02093676|"     It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit     from parents' counselling, guided by the New Authority model.   "
56211|NCT02549872|"     Most patients with dementia in the UK use their local hospitals and general (family)     practices throughout their illness. Linked electronic health records from primary care,     hospital and death certificates records therefore provide useful information about the     diagnosis and prognosis of patients who develop dementia.      In this study we will assess the validity of dementia diagnoses in linked primary care,     hospital and death records, by examining the timing of important health transitions in     patients with recorded dementia, and we will estimate the lifetime risk of recorded dementia     in different age and sex groups   "
56212|NCT02549859|"     Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that 60Hz stimulation,     compared to the traditional 130Hz, decreased the aspiration frequency and swallowing     difficulty, medication refractory freezing of gait (FOG), and other axial symptoms and     parkinsonism in Parkinson patients with bilateral STN DBS. The benefit of 60Hz stimulation     persisted during the 6-week study period, with worsening tremor in one patient. However, it     remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period,     and whether there is carry-over effect across different conditions. Clarifying these     questions is essential for the application of 60Hz stimulation chronically and confidently to     treat medication refractory axial symptoms. Hence, the investigators would test the     hypothesis that the 60Hz stimulation, compared to 130Hz, would have persistent benefit over     an extended period (on average > 8-month study period) in reducing the swallowing     dysfunction, FOG, and other axial symptoms in PD patients with bilateral STN DBS and     medication refractory FOG at 130Hz stimulation, even after correcting the potential     carry-over effects between stimulation conditions.   "
56213|NCT02549846|"     Investigators will study whether immediate statin treatment after the onset of stroke is     beneficial on the neurological protection   "
56214|NCT02549833|"     This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which     surgical resection of the tumor is clinically indicated. Co-primary objectives are to     determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the     regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive     to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected     glioma.   "
56215|NCT02549820|"     CDH is a birth defect characterized by the development, very early in gestation, of a hole in     the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result,     the intestines and other organs in the abdomen can move into the chest and press on the     developing lungs. This prevents the lungs from growing and developing normally.      In severe cases, CDH can lead to serious disease and death at birth. For these babies,     treatment before birth may allow the lungs to grow enough before birth so these children are     capable of surviving and thriving.   "
56216|NCT02549807|"     Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP)     have both muscles spastic and paresis. These movement disorders are likely to cause muscle     changes both structural and viscoelastic involved in the alteration of neuromotor functions     such as walking. Therefore, it seems interesting to study the structure of these muscles with     available imaging techniques. The medial gastrocnemius muscle presents architectural     characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the     reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular     thickness, particularly in children. In addition, the sonoelastometry by Supersonic ShearWave     Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the     calculation of the modulus of elasticity within a muscle tissue. This allows to consider new     perspectives evaluation of the viscoelastic properties of the muscle. No studies have     evaluated the reproducibility of this method in adults/children/ adolescent after stroke and     hemiplegia.   "
56217|NCT02549794|"     According to CT technology development, cardiac CT is very useful examination as noninvasive     examination and the accuracy in locating lesions has increased to 95%. Specifically, cardiac     CT has been performing a gateway role in reducing invasive cardiac angiography implemented     solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac     angiography. However, cardiac CT also comes with the disadvantage that patients cannot avoid     being exposed to radiation, so there has been much effort in appealing to reduce exposed     radiation dose. Of these methods, the most effective is the method of repeatedly     reconstitution by way of synchronized prospective ECG while using low tube-based potential.     According to recent studies, the SNR(Signal Noise Ratio) and CNR(Contrast Noise Ratio) values     representing image quality have been higher compared to the combined method of image     reconstruction by makeshift filtered back projection and condition of image acquisition by     patient BMI. Also, the administered amount of contrast agent can be reduced for achieving the     same contrast effect due to the advantage of the increased effect of contrast enhancement by     using low tube voltage. Therefore, the efficacy studies of using low concentration of     contrast agents in conditions of using low tube voltage are being processed.      This study intends to prove that image quality does not deteriorate by suitable image     reconstruction method with low concentration contrast agent compared to the combined method     of the makeshift filtered back projection image reconstruction method and the conditions of     image acquisition according to BMI with general amount of contrast agent.   "
56218|NCT02549781|"     In France, the prevalence of problem gambling and risk has been estimated at 1.3%. This     disorder, currently considered a behavioral addiction is characterized by a loss of control     and an excessive focus on the game.      The literature on intervening psychological mechanisms in the development of the game led to     think that the size of loss of control, central among players, could be understood as a     reduction in control capacity but also as automatic activation behavior game.      The task of Go-Nogo, commonly used in cognitive psychology, assesses the automatic and     controlled components of behavior. Furthermore, different models of the concept of addiction     underline the importance of the environment associated with addiction. However, no study     takes into account the interaction between the game environment and the involvement of these     mechanisms.   "
56219|NCT02549768|"     Use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its relation     to cortisol levels during postoperative period.   "
56220|NCT02549755|"     It is thought that PET of the abdomen with 11C Acetate will provide new information regarding     whether or not patient's have benefited from radiotherapy. To test this theory, the project     will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of     treatment success.   "
56224|NCT02549703|"     While the last several years have seen great strides in the treatment of relapsing forms of     MS, progressive MS, responsible for the majority of MS-related disability, lags far behind.     Despite much research, the lack of understanding related to what causes patients' relentless     decline in function results in an inability to develop targeted treatment strategies suitable     for clinical trials. This grant has two main goals.      The first goal is to extend the investigators preliminary study on rat neurons treated with     the CSF of MS patients to a larger number of Progressive patients in order to validate the     initial findings and extend the study to include analysis of human neurons. The initiating PI     (Dr. Casaccia) and the Partnering PI and Clinical Neurologist (Dr. Katz Sand) have recently     identified components that are present in the CSF of progressive patients that impair the     ability of rat neurons to produce energy. The partnering PI, Dr. Quinzii (Columbia     University) together with collaborator Dr. Fossati (NY Stem Cells Foundation), have     characterized human neurons generated from stem cells derived from skin biopsies of     progressive patients and detected the presence of energetic deficits. The experimental plan     will build on these results and test hypotheses of disease progression. The overall goal is     to improve understanding on how to stop neurons from degenerating and stop clinical     progression.      The second goal is to ask whether it is possible to define a progressive disease course on     the basis of combined biochemical, functional and imaging measurements. The initiating PI     will be responsible for the biochemical assessment of CSF and serum samples and, together     with partnering PI Quinzii, will also provide functional bioassays measurements of     mitochondrial bioenergetics impairment in patients. These data will be combined with clinical     assessment and MRI evaluations conducted by the partnering PI Katz Sand and collaborator     Inglese. A two year clinical and imaging follow up from the initial recruitment will allow to     define whether the combined measurements can be used by clinical neurologists to define the     disease course and better identify therapeutic options for patients.      The expectation is that the completion of the stated aims of research will allow an     advancement of the current knowledge of the progressive form of MS and lead to potential new     therapeutic targets.   "
56225|NCT02549690|"     The main purpose of this study is to compare the number of oocytes retrieved after using     transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for     6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization     (IVF).   "
56226|NCT02549677|"     The purpose of this study is to compare the safety and efficacy of epirubicin plus     cyclophosphamide versus docetaxel plus cyclophosphamide in lymph node negative, estrogen     receptor (ER) positive, human epithelial growth factor receptor 2 (HER2) negative breast     cancer patients as adjuvant chemotherapy.   "
56227|NCT02549664|"     The goal is to determine how lifestyle and exercise impact the well-being of individuals with     hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).   "
56228|NCT02549651|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736     alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed     or refractory dIffuse large B-cell lymphoma.   "
56229|NCT02549638|"     The study will utilize both retrospective and prospective data collection from patients that     already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection     for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic     biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients     who meet the study criteria.   "
56230|NCT02549625|"     The objective of this study is to determine the safety and feasibility of autologous     mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for     individuals with declining ventricle systemic pumps. This procedure has the potential to     foster a new strategy for congenital heart patients. This is an open-label study of     autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related     serious adverse events and 2) monitor changes in cardiac structure and function.   "
56231|NCT02549612|"     Secretory otitis media (SOM) or middle ear effusion is a common finding after acute otitis     media (AOM). It is usually associated with 5-15 deci Bells hearing loss. Although spontaneous     resolution with normalisation of hearing is the usual outcome, this can take several months.     Secretory otitis media is the most common cause of hearing impairment in the paediatric age     group. When the hearing loss caused by SOM is bilateral and persists for 3-6 months or more,     surgery with tympanostomy tube insertion under general anaesthesia is indicated. In Sweden,     10000 children undergo this operation annually. Although many children with unilateral or     bilateral SOM improve in the summer, the problem usually recurs in the autumn or winter. The     cost of SOM for the Swedish society was 600 million Swedish crowns 2005.      In two previous studies, the investigators concluded that the nonsurgical treatment method,     that was developed to assist children with SOM equalising their middle ear pressure, could     normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months.     These children avoided therefore grommet insertion.      The investigators would like to assess the effect of this new treatment method on hearing     directly after AOM. The investigators expect that using the new method could rapidly     normalise hearing in these cases and thereby operation with grommet insertion could be     avoided.   "
56232|NCT02549599|"     The primary aim of the proposed project is to conduct a randomized controlled trial to     evaluate the efficacy of a digital intervention tool that enables young people to correspond     with trained staff via online chat or text messages about urgent questions related to     sexual/reproductive health.   "
56233|NCT02549586|"     This open-label, proof-of-principle two center cohort study will evaluate the ability of     autologous hematopoietic stem cell transplantation to induce tolerance in recipients of     deceased or live donor liver transplants (ASCOTT). A maximum of 10 participants will be     entered at a minimum of 3 months post liver transplant. The participants will undergo     autologous hematopoietic stem cell transplants (HSCT) to re-educate their immune systems to     accept the graft without the need for long term immunosuppression (tolerance).   "
56234|NCT02549573|"     To determine if PT intervention will be improved while in the on motor state vs. the     end-of-dose-off motor state during the PT Intervention Visit in subjects with PD.   "
56235|NCT02549560|"     Postoperative cognitive dysfunction (POCD) is a contrary event observed between 20 to 83%,     especially on elderly and patients submitted to cardiac surgery. The prevention and     rehabilitation on cases of POCD can improve the quality of life and decrease the mortality in     surgical patients. The effect of the noninvasive cerebral stimulation, also known as     transcranial Direct Current Stimulation (tDCS) has been studied to be used in the treatment     of brain injuries and depression, and also in the cognitive rehabilitation. The hypothesis is     that the use of the tDCS technique can decrease the occurrence of POCD and cognitively     rehabilitate patients submitted to cardiac surgeries.   "
56331|NCT02548299|"     This study is a multi-dimensional therapeutic lifestyle program that offers cooking and     nutrition education as well as email-based health coaching to diabetic patients in an     underserved Cleveland community. This is an innovative project as it is one of the first     focused efforts within this community to improve diabetes control and prevent diabetes     progression through cooking and nutrition as well as to systematically measure both clinical     and behavioral outcomes.   "
56236|NCT02549547|"     The WHO, the Pan American Health Organization, the EU Council of Ministers, the World     Federation of Mental Health, and the UK Royal College of Psychiatrists all agree -there can     be no health without mental health. Within Canada, 6.7M people live with a mental illness     and when family and caregivers are included almost everyone is affected.      A systematic review (2014) concluded that physical activity has a significant potential for     reducing depressive symptoms in people with a mental illness. Globally, physical inactivity     is pandemic. Current guidelines recommend a minimum of only a 150 minutes a week of     moderately vigorous exercise but 85% of Canadians do not meet the national recommendations.     How then can people with depression be motivated to become physically more active?      Group Medical Visits (GMVs) can be used to provide health services and they have proven     effective in some settings, including mood disorders. As well as providing economic and     resource efficiencies, the GMV model has the potential to add a 'support     group/accountability' element for behavioural interventions such as physical activity     promotion; such influence is not present in an individual patient-physician consultation.      Jump Step is a 14-week program within a GMV setting designed to motivate and support people     with depression to engage in regular physical activity. The investigators seek to design,     implement, and evaluate the effectiveness of the Group Medical Visits focused on promoting     physical activity for patients with depression.   "
56237|NCT02549534|"     Purpose: The purpose of the study is to test a new way of measuring nerve damage in women     with breast cancer receiving chemotherapy drug paclitaxel (Taxol).   "
56238|NCT02549521|"     Calcium and vitamin D substitution has for a long time been used to improve osteoporosis.The     main storage place for magnesium is in the bone. Magnesium is direct under calcium in the     periodic system making it possible to interact with the crystal structure. Some small studies     have shown beneficial effects of magnesium substitution on osteoporosis. Evidence has shown     improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. It has been     uncertain however, which of these factors can contribute to such a change. The effect of     magnesium substitution 240 mg daily as therefore studied in two parallel groups where both     received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got placebo and the     other received magnesium. This was studied on various expressions for bone metabolism after     zero, seven and 28 days in elderly females aged 70 years old.   "
56239|NCT02549508|"     The purpose of this research is to examine the application of AutoCPAP with and without     SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate     whether patients achieve better sleep quality and compliance with SensAwake, compared to the     same treatment without SensAwake.   "
56240|NCT02549495|"     This study evaluates the effectiveness of community health workers when added to routine care     for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It     does so by recording information on adherence to therapy, blood pressure and blood sugar     while a non-governmental organization working in Mexico trains and introduces a community     health worker program.   "
56241|NCT02549482|"     13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask     fitted with an inspiratory and expiratory resistor. A brachial arterial catheter was used to     measure blood pressure and thus systolic pressure variation and pulse contour analysis     determined stroke volume and thereby cardiac output in order to detect a central volume     deficit.   "
56242|NCT02549469|"     Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3     different sustained release formulations of naproxen 660 mg relative to the established     commercial Aleve 220 mg tablet.   "
56243|NCT02549456|"     The purpose of this study is to assess different hybrid natural orifice transluminal     endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of     the technique, short term oncologic outcome and functional outcome.   "
56244|NCT02549443|"     This study evaluates whether providing a nutritional intervention in the form of insulin,     sugar and protein during and after open-heart surgery will increase the body's protein stores     and maintain a normal level of blood sugar. The primary outcome will be Whole body protein     balance which will be assessed by isotope tracer kinetics. Protein balance will be calculated     as protein synthesis minus protein breakdown with positive values indicating anabolism and     negative values catabolism. The preoperative measurements will be performed on the morning     before the operation. Postoperative studies will be conducted two hours after surgery in the     intensive care unit. Patients will be followed for 12 hours after surgery.   "
56245|NCT02549430|"     This study aims to assess the activity of PD0332991 in monotherapy and in combination with     the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the     patient has progressed in the previous line for advanced breast cancer in order to reverse     endocrine resistance.   "
56246|NCT02549417|"     This study is designed to evaluate efficacy and safety of KHK7580 orally administered once     daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal     dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week     extension period to evaluate long-term safety and efficacy.   "
56247|NCT02549404|"     This long-term study is designed to evaluate safety and efficacy of KHK7580 orally     administered once daily for 52 weeks for patients with secondary hyperparathyroidism     receiving hemodialysis.   "
56248|NCT02549391|"     The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally     administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT)     receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment,     parallel-group design with cinacalcet hydrochloride as an active control.   "
56257|NCT02549274|"     The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is     most often based on analgesics combined with physical therapy. More recently authors have     advocated the use of self-rehabilitation, that is to say, the use by the patient himself of     physiotherapy exercises to perform at home regularly. However, if there are currently many     studies on the effectiveness of self-rehabilitation for low back pain, there are few data on     neck pain.      In this context we have chosen to implement a prospective, randomized study, on the     effectiveness of self-rehabilitation in patients with chronic neck pain.   "
60074|NCT02499250|"     The purpose is to test whether daily ischemic conditioning of the arms over 30 days could     reduce the frequency and severity of angina pectoris and improve the life quality of     refractory angina pectoris patients.   "
56249|NCT02549378|"     The microcirculatory alterations is common in circulatory failure, especially during sepsis.     The severity of these changes and their sustainability are responsible of multi organ failure     and ultimately death. The optimization of microcirculatory flow could be a central objective     of the management of patients hospitalized in intensive care.      Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It     represents the largest heat exchange surface of the body and is involved in tissue     oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and     blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The     role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our     team and the oldest work in the literature lead to believe that CO2 has a specific role in     modulating microcirculatory flow. No study to date precisely studied the impact of changes in     the microcirculatory flow carbonemia .      The hypocapnia test is carried out in a standardized manner by inhalation of a mixture     enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn     obtained by a calibrated voluntary hyperventilation test.      Direct visualization of microcirculation by confocal microscopy is now considered the gold     standard for exploring the microcirculation.   "
56250|NCT02549365|"     The UK Departments of Health now recommend annual influenza vaccination for all children 2-7     years of age, with children over 7 years eligible for vaccination if in certain higher risk     clinical categories. Though data are available documenting the safety and immunogenicity of     LAIV in this age group, there are little data to assess efficacy and immune correlates in UK     children, and in particular atopic children. This study will enrol 200 children (and at least     200 unvaccinated household sibling controls), many with a history of asthma or recurrent     wheezing, and allow an assessment of efficacy, safety and immune correlates in these     children, and how this varies with prior administration of pandemic influenza vaccine and/or     LAIV.   "
56251|NCT02549352|"     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with     vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive     days as field treatment   "
56252|NCT02549339|"     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with     vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days     as field treatment   "
56253|NCT02549326|"     Obesity is associated with lower total serum 25-hydroxycholecalciferol (S-25OHD)     concentration. However, the impact of obesity on free S-25OHD is inadequately studied. A     direct assay for free 25OHD was introduced recently.      The aim of the study was to evaluate differences in vitamin D metabolism between young adults     with severe childhood-onset obesity and normal-weight controls. Half of the obese subjects     and controls will receive placebo and the other half will receive vitamin D3 50 µg daily for     12 weeks.   "
56254|NCT02549313|"     The position of the head of the patient influences the cerebral venous return and cerebral     perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a     Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on     precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure     (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC.     Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem unaffected     by changes of position of the head of the patient. But the whole of the literature on this     subject has significant bias.   "
56255|NCT02549300|"     The purpose of this study is to investigate the effects of connective tissue massage and     lifestyle modifications in adolescents tension type headache, pain severity, pain duration,     pain frequency and quality of life and pressure pain threshold rates. The patients will be     accepted to study according to 'The International Classification of Headache Disorders-III'     criteria. Including criteria are; being between 10-19 ages adolescents, suffering from     tension type headache at least for 6 months, pain severity between 4-7 on visual analog     scale. Excluding criteria are; current pregnancy, having any history of cancer, traffic     accident, head trauma and any kind of neurological disorder. Patients will be divided into     two groups randomly. The investigators plan to receive 30 patients to the study. 15 of them     will be in control group, 15 in study group. Control group will just receive some advices     including life style modifications, like using right glasses, not smoking, true posture     habits and regular and quality sleep habits. In addition to life style modifications, the     other group will be treated with connective tissue massage. Connective tissue massage will be     applied on basic part, lower thoracic, scapular, inter scapular and neck regions, 5 times a     week, totally 20 sessions in a month. Each session lasts approximately 20-30 minutes.     Patients detailed medical history and demographic data will be recorded. Pain severity,     duration, frequency, analgesic usage, connective tissue evaluation of back, range of motion     of neck, pressure pain threshold for pain sensitization measurements and quality of life will     be evaluated before treatment and after 4 weeks of treatment.   "
56256|NCT02549287|"     The purpose of this study is to conduct an effectiveness trial of the SafeCare model for     parents with substantiated maltreatment. SafeCare, a behavioral parenting program will be     compared to supportive case management (SCM), which is a process oriented service aimed at     building rapport, providing family support, crisis management, and provision of referrals to     additional services. The SafeCare model is a promising intervention for child maltreatment,     but has not been broadly compared to usual services across a variety of service setting, and     it has not been evaluated with respect to client outcomes of well-being, or service delivery     burden, satisfaction, and perceived effectiveness. The study aims are as follows:      (1) Compare SafeCare to SCM on parent and child outcomes including parenting skill, parenting     stress and emotional well-being, parent-child relationship, parent and child well-being, and     child adaptive behavior. (2) Compare SafeCare to SCM on how families and providers perceive     each intervention, specifically with regard to burden, satisfaction, and program impact. (3)     Compare SafeCare to SCM on ability to reduce child welfare re-reports. (4) Examine     variability in SafeCare effects across sites and client characteristics.   "
56268|NCT02549131|"     The purpose of this randomized controlled prospective trial is to guide physicians on the     most effective evidenced based skin closure during a cesarean section for the obese gravida,     defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular     sutures and surgical staples.   "
56269|NCT02549118|"     The aim of this study is to assess whether tenoxicam is as effective as pethidine for     analgesia during the first stage of labor.   "
56258|NCT02549261|"     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     efficacy has been shown in adult with head and neck cancer. The study assessed the efficacy     and safety of the combination of Nimotuzumab administered concomitantly with     chemoradiotherapy in patients with NSCLC .There is a tolerance trial of Nimotuzumab in     Combination With Radiochemotherapy treatment before the randomization,double     blind,muti-center sites trial of this treatment.   "
56259|NCT02549248|"     Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres.     Over the past decade, industrial applications of NP have increased dramatically. Despite     their widespread use, their true impact on human health remains unknown and poorly studied.     NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim     of this study is to estimate the relationships between the nanoparticle load in the lung and     bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos,     the pathological consequences of environmental exposure to nanomaterials could be evaluated     upon a mineralogical analysis of pulmonary samples.   "
56260|NCT02549235|"     The purpose of this trial is to evaluate the morphological characteristics of the uterus with     three-dimensional ultrasound (3DUS) at the time of embryo transfer in women undergoing     IVF/ICSI treatment and correlate it to clinical outcomes. The uterus will be assessed in the     3D coronal plane and measurements including the fundal wall thickness, fundal wall     indentation and interostial distance will be performed to assess whether they correlate with     clinical pregnancy rate, miscarriage rate and live birth rate.   "
56261|NCT02549222|"     This study is a prospective, non-randomized sequential cohort, open label, multi-center,     non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The     patient population will be hematology-oncology patients, including those undergoing     hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions.      For each participating center, the study will start with a brief pilot run-in period with a     group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot     run-in is to evaluate study logistics and data collection methods within each study center.     Data from the pilot phase will be included in the data listings but not included for the     treatment comparison.      After the pilot run-in period, the study will be conducted in two sequential patient cohorts:     1) the Control cohort during which study patients will receive only conventional PCs, and 2)     the INTERCEPT cohort during which patients will receive only INTERCEPT PCs. Patient     enrollment at each Center will be monitored to target similar numbers of patients into the     Control and Test Cohorts within each center. Within each Center, patient enrollment will be     stratified in four categories: (1) chemotherapy only; and by use of conditioning regimens for     hematopoietic stem cell transplantation (HSCT) in (2) myeloablative conditioning, (3)     non-myeloablative conditioning, and (4) reduced intensity using the Center for International     Blood and Marrow Transplant Research (CIBMTR) criteria. To ensure both Test and Control     cohorts have a similar allocation ratio (±10% per category) among the conditioning regimen     strata, enrollment caps will be set for the Test cohorts, hence no Test patients will be     enrolled to a stratum once the cap for the given stratum is met.   "
56262|NCT02549209|"     This is a single-arm, open-label, multi-center phase II study for subjects with measurable     advanced or recurrent endometrial cancer using pembrolizumab in combination with carboplatin     and paclitaxel chemotherapy. As this combination of agents has not been tested in this     subject population, the first six subjects enrolled will constitute a safety run-in cohort.   "
56263|NCT02549196|"     This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's     type to determine the optimal dose titration schedule.   "
56264|NCT02549183|"     Clinical study to estimate the optimal frequency for stimulation of the spinal cord to     achieve relief from back pain.   "
56265|NCT02549170|"     This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate     the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human     hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent     relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10%     administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult     subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen     (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6     weeks) of IGIV therapy for at least 3 months prior to screening. In this double-blind,     placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a     1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20     every two, three, or four weeks in a double-blind fashion for a period of 6 months or until     relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for     a period of 6 months.   "
56266|NCT02549157|"     The research aims to assess the relationship between treatments for a range of     urogynaecological problems (pelvic floor dysfunction, cancers) and patient reported values,     psychological states, and quality of life. The impact of treatments on the patients' health     outcomes will be measured, using specific urogynaecological outcome measures (for either     pelvic floor dysfunction or cancer), and patient reported measures of general health and     quality of life. Patients' psychological states and values will be measured by validated self     report instruments for these areas. Researchers will obtain consent for participation from     patients. Following consent, baseline measures will be taken at the patients' routine     appointment about 4weeks prior to undergoing treatment (e.g., surgery or physiotherapy for     pelvic floor dysfunction, or surgery for a urogynaecology cancer). These measures will be the     routinely collected physical data obtained by medical staff, and patient reported measures of     their general health (GHQ28), psychological state (HADS; PVQII), and quality of life     (EuroQual5D, WHOQoLBREF, QRS, QLQC30). These questionnaires should take about 30 minutes to     complete, in total. The patients will then undergo their treatment (physiotherapy programme     or surgery), which will not be affected in any way by this research. Researchers will obtain     consent for participation from patients. Following consent, baseline measures will be taken     at the patients' routine appointment about 4 weeks prior to undergoing treatment (e.g.,     surgery or physiotherapy for pelvic floor dysfunction, or surgery for a urogynaecology     cancer). These measures will be the routinely collected physical data obtained by medical     staff, and patient reported measures of their general health (GHQ28), psychological state     (HADS; PVQII), and quality of life (EuroQual5D, WHOQoLBREF, QRS, EORTC QLQC30). These     questionnaires should take about 30 minutes to complete, in total. The patients will then     undergo their treatment (physiotherapy programme or surgery), which will not be affected in     any way by this research. About four weeks post treatment, patients will receive their usual     appointment, and routinely collected physical data will be obtained by medical staff, and     patients will complete the measures as described above. With the patient's consent, the above     evaluation will be repeated at every follow-up appointment that the patient has (i.e. after     3months, and then at yearly intervals, for 5 years). The impact of treatments on objective     routine health measures taken by medical staff, and on patient reported measures of health,     quality of life, personal values, and psychological functioning, will be documented at each     measurement point. Additionally, relationships between psychological states/values and both     objective and subjective ratings of how treatments have impacted the patients will be     established.   "
56267|NCT02549144|"     In this study the investigators aimed at measuring the effect of a two-week     high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition     and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.   "
56270|NCT02549105|"     A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration     with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.   "
56273|NCT02549066|"     Cardiac surgery with cardiopulmonary bypass (CPB), especially when oxygen delivery is low, is     associated with acute kidney injury. Unpublished data shows that renal oxygen delivery is     compromised during CPB due to low hematocrit and redistribution of blood flow away from the     kidneys. We wish to study if increased CPB flow can improve renal oxygenation.      Patients who develop cardiac failure after weaning from CPB will be treated as per our     departments routine with the inotropic agent milrinone, and measurements will be made before     and after treatment.   "
56274|NCT02549053|"     The aim of this study was to determine whether the prevalence of Human PapillomaVirus (HPV)     was increased in patients with Barrett esophagus compared with controls in a prospective     study. Secondary objective was to identify, if present, the type of Human PapillomaVirus     (HPV) associated in Barrett esophagus.   "
56275|NCT02549040|"     This study aims to evaluate and compare the relative bioavailability of different MK-1439     experimental nano formulations (NFs) with that of a MK-1439 film coated tablet.   "
56276|NCT02549027|"     The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is     to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as     measured by polysomnography (PSG) in healthy young male participants, and to evaluate the     safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male     participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is     superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.   "
56277|NCT02549014|"     The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the     safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in     healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least     one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064     plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment     of MK-1064 in humans, the study protocol allows for modifications to the outlined dose,     dosing regimen and/or clinical or laboratory procedures, if required to address study     objectives and/or to ensure appropriate safety monitoring of participants.   "
56278|NCT02549001|"     The purpose of this study is to determine whether P-3058 nail solution is a safe and     effective treatment for onychomycosis.   "
56279|NCT02548988|"     The purpose of this study is analyze the immediate effect of selective neuromuscular     electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO     and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral pain     syndrome.   "
56280|NCT02548975|"     This study will evaluate several potential risk factors for postoperative delirium in cardiac     surgery patients. The risk factors will include use of specific preoperative, intraoperative,     and/or postoperative medications. Other risk factors investigated may include exposure to     cardiopulmonary bypass, surgical technique, and or duration of surgery.   "
56281|NCT02548962|"     Phase 1 will be an open-label, dose finding, multicenter study of ibrutinib in combination     with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.      Phase 2b will be conducted as a randomized, double-blind, multicenter study of ibrutinib or     placebo, in combination with pomalidomide and dexamethasone in subjects with     relapsed/refractory multiple myeloma.   "
56282|NCT02548949|"     On 6 Feb 2014, Pristiq was approved for the treatment of Major Depressive Disorder(MDD) in     Korea. In accordance with the Standards for Re-examination of New Drug, it is required to     conduct a PMS for 600 patients by 5 Feb 2020. Post marketing surveillance is required to     determine any problems or questions associated with Pristiq after marketing, with regard to     the following clauses under conditions of general clinical practice. Therefore, through this     study, effectiveness and safety of pristiq will be observed.   "
56283|NCT02548936|"     This is a randomized single-blind trial. This study aimed to determine if intensive     lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the     progression of atherosclerosis effectively and safely among SLE patients with carotid artery     intima thickening. The study results were expected to be helpful for SLE patients in     preventing atherosclerosis.   "
56284|NCT02548923|"     The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for     prolonged sedation in trauma and surgical patients.   "
56285|NCT02548910|"     Major liver resection is associated with substantial intraoperative blood loss. Blood loss in     elective liver surgery is a significant factor of perioperative morbidity and mortality, as     well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood     phlebotomy to decrease the central venous pressure, resulting in a state of relative     hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss     at the time of liver resection.   "
56286|NCT02548897|"     The purpose of this study is to investigate brain signals related to freezing of gait (FoG),     a symptom of Parkinson's Disease, that can lead to dangerous falls. The investigators     hypothesize that uncovering these signals can lead to better deep brain stimulation     interventions.   "
56287|NCT02548884|"     The purpose of the study is to compare two different techniques (pancreatic sphincterotomy     (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and     the success of cannulation in difficult cannulation. For the study, the difficult cannulation     is de-fined as situation when the common bile duct has not been cannulated in five minutes,     after five attempts or after two pancreatic guide wire passages or when any of those limits     is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The     primary end-point is the risk of PEP .   "
56288|NCT02548871|"     The purpose of this study was to determine the impact of TOP® on sexual health behavior.   "
56289|NCT02548858|"     The purpose of this study is to determine whether performing a perineorrhaphy during a     reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body     image.   "
56290|NCT02548845|"     In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment     of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in     oncology patients was developed. Since it is hypothesised that the adherence to the SEOM     algorithm is not 100%, the current retrospective non-interventional study will investigate     the perceived and actual adherence of participating centres to the SEOM algorithm and its     impact on patient outcomes   "
56291|NCT02548832|"     Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has     increased over the last decade. Part of the components of metabolic syndrome and consensus so     far contemplated to increased triglycerides and reduced HDL-C as part of the elements for     classification, which includes mixed dyslipidemia.      Currently fibrates, such as bezafibrate, are drugs whose utility in treating     hypertriglyceridemia is fully proven, besides reducing the risk of coronary disease. However,     although this treatment is safe, it is not without risks; with increased prevalence of     adverse effects as the dose thereof is increased or joins combination with a statin drug for     the treatment of mixed dyslipidemia long term.      Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides     may be useful in combination with the bezafribrato in the treatment of mixed dyslipidemia and     as an option with lower cost and lower frequency of adverse events.   "
56292|NCT02548819|"     A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic     magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and     implantable cardioverter defibrillators).   "
56293|NCT02548806|"     The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg     and 100 μg Clonidine and comparative bioavailability of clonidine with that from the     Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy     subjects.   "
56294|NCT02548793|"     Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival     for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than     one third of witnessed SCA events. A number of barriers to bystander CPR training have been     identified including time and cost of the training course. Since the large majority of arrest     events occur in the home environment, studies have suggested that providing CPR training to     family members of hospitalized cardiac patients may serve as a useful approach to address an     environment in which bystander CPR is frequently not provided. Utilizing an existing     in-hospital program to train adult family members, the investigators will assess the skills     of those who learn CPR through two different educational methods: a mobile app and video     self-instruction (VSI).   "
56295|NCT02548780|"     The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and     efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable     HCC.   "
56296|NCT02548767|"     It is not known whether consumption of excessive amounts of sugar can increase risk factors     for cardiovascular disease or diabetes in the absence of increased food (caloric) intake and     weight gain, nor whether the negative effects of sugar consumption are made worse when     accompanied by weight gain. This study will investigate the effects of excess sugar when     consumed with an energy-balanced diet that prevents weight gain, and the effects of excess     sugar when consumed with a diet that can cause weight gain. The results will determine     whether excess sugar consumption and excess caloric intake that lead to weight gain have     independent and additive effects on risk factors for cardiovascular disease or diabetes, and     will have the potential to influence dietary guidelines and public health policy.   "
56297|NCT02548754|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental     studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at     voltages substantially below that which slowed the sinus rate, significantly suppressed AF     inducibility and decreased AF duration. The investigators subsequently developed a     non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch of     the VN located at the tragus, the anterior protuberance of the outer canine ear (low level     tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those of LLVNS     delivered to the cervical VN trunk. More recently, in a proof-of-concept study in humans, the     investigators showed that in patients with drug-refractory AF undergoing AF ablation, LLTS     for just one hour significantly shortened the AF duration and decreased inflammatory     cytokines.      The overall objective of this proposal is to translate in ambulatory patients with paroxysmal     AF the results of previous studies showing acute suppression of AF and inflammation in     anesthetized canines as well as humans, in order to examine the long-term therapeutic effects     of this approach. The investigators hypothesize that intermittent (1 hour daily) LLTS for 6     months may result in long-term decrease of AF burden and suppression inflammatory cytokines     in patients with paroxysmal AF. Patients will be randomized to either active or sham LLTS.     LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device     for 1 hour daily over a 6-month period. AF burden will be defined as the percent of time     spent in AF over a 2-week period, assessed by noninvasive continuous ECG monitoring at     baseline and at 6 months. In addition, blood samples will be collected from patients at     baseline, and at 3 and 6 months, for cytokine measurement. These investigations will     establish the first evidence of the long-term effects of LLTS on AF suppression in patients     with paroxysmal AF and may provide the basis for a potential expansion of the therapeutic     targets of this treatment modality beyond AF.   "
56298|NCT02548741|"     This study is designed to investigate the effects of metformin, a commonly prescribed first     line medication for diabetes and recommended for prediabetes, on the levels of the     potentially tissue damaging reactive product (MG) in the blood and its cleared counterpart in     the urine (IMZ). The study will involve patients with elevated HbA1c randomized to receive     either metformin or a similar inactive placebo pill and a group of sex and age matched     volunteers without diabetes. Study participants will be recruited from the University of     Arizona Medical Center, South Campus clinics (Endocrine clinic, family medicine clinic and     general medicine clinic). Eighty patients with HbA1c >6.0% will be randomized to receive     either metformin or a similar inactive placebo for 6 weeks. The response of these patients     will be compared to 40 patients normal HbA1c <5.6% who will not receive either study     medication. Investigators will compare the plasma MG and urine IMZ concentration/content     between the 3 groups before and after the 6-week intervention. It is hypothesized that plasma     MG level in the metformin treatment group will be less than in the group taking the placebo     pills, while there will be no significant difference in MG level between the metformin     treatment group and the volunteers without diabetes.   "
56299|NCT02548728|"     Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases     use of and cravings for opioids (narcotics) in people who have been using opioids heavily for     long periods of time and are unable to stop on their own.      Participants: Patients meeting DSM-IV-TR criteria for opioid dependence.      Procedures (methods): Subjects will have standard medications available for withdrawal     symptoms from opioids and standard psychosocial interventions available in the inpatient     setting. In addition, subjects will self-administer intranasal test treatments 3 times daily.   "
56332|NCT02548286|"     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330     (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with     coadministration of the two separate drugs in healthy male volunteers.   "
56333|NCT02548273|"     This study aims to assess the corneal damage after phacoemulsification and to assess the     factors causing it in diabetics in comparison with non-diabetics.   "
56300|NCT02548715|"     Patients that require treatment for cancers of the head and neck often require a combination     of surgery and/or radiation and chemotherapy. Hypothyroidism is one of the most common     complications, and has been associated with post-operative complications such as wound     healing problems, fistula formation, and decreased quality of life and survival. Several     studies have examined hypothyroidism after radiation to the head and neck, but few have     examined this after non-thyroid head and neck surgery. Head and neck resection is theorized     to devascularize the thyroid, thus resulting in post-operative hypothyroidism.      Synthroid is a synthetic thyroid hormone often used in cases of patients with proven     hypothyroidism and after surgical thyroid removal. It's use has been in effect and studied     for over fifty years.      Treatment algorithms for hypothyroidism are well published. However, treatment of subclinical     hypothyroidism (elevated TSH with normal or near-normal T3/T4) is controversial. The rate of     subclinical hypothyroidism after non-thyroid head and neck surgery is high (up to 20%), and     is associated with post-operative complications as noted above.      Therefore the investigators propose a double blinded randomized controlled trial comparing     outcomes of patients that develop subclinical hypothyroidism after head and neck surgery, who     are given a standardized dose of synthroid treatment versus those treated with placebo. The     main outcomes to be examined are post-operative complications (wound healing issues, fistula     formation), survival, and quality of life measures.   "
56301|NCT02548702|"     The Fit4Life intervention aims to engage inactive patients with type 2 diabetes in a     community-based sport intervention, with the aim being that all participants complete 1 x 30     min session of physical activity/exercise per week across the 12 months they are involved in     the intervention (total study duration 3 years).      The aim of the Fit4Life intervention is to slow the progression of disease symptoms and to     improve quality of life in those diagnosed with type 2 diabetes. The aim of this research     study is thus to evaluate the effectiveness of the intervention in achieving these aims. The     hypothesis is that involvement in the Fit4Life programme will increase physical activity,     reduce type 2 diabetes disease symptoms and enhance self-reported quality of life in male and     female patients aged 35-64.   "
56302|NCT02548689|"     This study will investigate whether subjects who suffer from hair loss have increased levels     of PAI-1 compared to age-matched control subjects. The level of PAI-1 expression will be     determined in subjects without hair loss and in subjects with non-scarring hair loss,     including androgenetic alopecia, telogen effluvium and alopecia areata.   "
56303|NCT02548676|"     Glaucoma is one of the leading causes for blindness in industrialized countries. It is     characterized by a progressive loss of retinal ganglion cells, morphological changes in the     optic nerve head and a characteristic loss of visual field. It has been speculated for a long     time that vascular factors may also contribute to the pathogenesis of the disease. This     concept has been supported by several epidemiological studies showing that small retinal     vessel calibre are associated with the disease. In the recent years tremendous enhancements     in the field of optical coherence tomography has been achieved. These developments made it     possible to visualize the retinal vasculature in a full depth manner without the application     of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma     show altered vascular morphology compared to healthy subjects. This is of importance because     it may clarify the degree of vascular involvement in glaucoma.   "
56304|NCT02548663|"     This project assessed muscle oxidative metabolism and fatigue in patients affected by     amyotrophic lateral sclerosis (ALS) undergoing to three months of individualized     cardiovascular and strength training. Muscle oxidative metabolism and strength will be     assessed by non-invasive methods, such as near-infrared spectroscopy (NIRS) and     mechanomyography (MMG). NIRS is a technique giving indications on the capacity of oxygen     extraction of muscles during exercise. MMG allows analyzing the pattern of motor unit     recruitment and related fatigue. The investigators will also assess the effects of training     on pain tolerance and quality of life (QoL) by the Brief Pain Inventory and the McGill     Quality of Life questionnaires, using the validated Italian versions. Patients will be     assessed longitudinally before (time T0) and after three months of individualized training     (time T1). After one month of de-training (time T2) the investigators will assess the     hypothetic persistence of any treatment-related effect. The effect of three     months-osteopathic treatment (osteo) on pain and QoL will be assessed as well.   "
56305|NCT02548650|"     Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor, more frequently     clopidogrel, represents the standard of care for the long-term secondary prevention of     atherothrombotic events in patients with myocardial infarction (MI) or peripheral arterial     disease (PAD). However, rates of ischemic recurrences remain high. Vorapaxar is a     protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of     thrombin-mediated platelet aggregation. Patients with diabetes mellitus (DM) are known to be     at increased risk of recurrent atherothrombotic events, which translates into worse outcomes,     despite the use of standard of care therapy. This is in part due to the hyperreactive     platelet phenotype, which characterizes DM patients, and to inadequate response to oral     antiplatelet agents, including clopidogrel. Therefore, vorapaxar is an attractive treatment     option for DM patients with a prior MI. The pharmacodynamic (PD) effects of vorapaxar in DM     patients and how these may differentiate from non-DM patients has not been explored. Further,     the role of vorapaxar as part of a dual antithrombotic treatment regimen combined with     clopidogrel (and stopping aspirin) represents another important area of clinical interest.     The proposed prospective, parallel-design study conducted in patients post-MI or with PAD     with and without DM will aim the assess the pharmacodynamic effects of vorapaxar in addition     to standard DAPT with aspirin and clopidogrel as well as in combination with clopidogrel only     following aspirin withdrawal.   "
56306|NCT02548637|"     Researchers at the John Wayne Cancer Institute (JWCI) at Providence Saint John's Health     Center (PSJHC) are trying to examine whether acupuncture reduces joint pain in patients being     treated with aromatase inhibitor (AI) therapy for breast cancer and whether the reduction in     pain happens by lowering inflammation.   "
56307|NCT02548624|"     The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in     measuring position changes of a non-patient subject in a lab setting and to examine the     effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.   "
77783|NCT02267733|"     A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing     schedule for patients with monoclonal gammopathies stratified by disease status   "
56308|NCT02548611|"     Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary     interventions is associated with improved outcomes after coronary stenting. However the onset     of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very     variable. A way to overcome this limitation is loading with a more potent antiplatelet drug     such as prasugrel. Therefore in the current study the investigators want to compare loading     with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug)     in patients undergoing elective coronary intervention.   "
56309|NCT02548598|"     This is a cross-sectional, non-interventional study, consisting of three study arms, (1) Full     Characterization (AIMS-Full), (2) Surgery Arm (AIMS-OR), and (3) Mucus Collection (AIMS-M).     Participants will be recruited and enrolled in either AIMS-Full or AIMS-OR (based on     participant availability). Participants who complete the initial characterization study     (either AIMS-Full or AIMS-OR), may also go on to participate in the AIMS-M arm, which focuses     mainly on sample collection. Participants who choose not to participate in either     characterization arm are able to enroll directly into AIMS-M for sample collection only.   "
56310|NCT02548585|"     A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the     efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes     Mellitus (T2DM).   "
56311|NCT02548572|"     Several studies have shown that TES in RP patients may help to slow the progressive     deterioration of this degenerative disease. The end point of this clinical trial is to slow     or stop disease progression with weekly treatment using TES for 1 year.   "
56312|NCT02548559|"     This study evaluates the effects of cannabidiol (CBD) for the treatment of anxiety in adults     certified for medical marijuana. Participants will use a sublingual (under-the-tongue)     tincture of whole plant derived CBD three times daily for four weeks in addition to their     normal treatment regimen. Participants' clinical state will be assessed weekly during the     treatment period. In addition, cognitive function and measures of quality of life, sleep,     general health, and multimodal neuroimaging will be assessed at baseline and the     post-treatment final visit.   "
56313|NCT02548546|"     The primary aim of this study is to establish the practicality of using two novel imaging     modalities for the assessment of biomechanical properties of the aorta.   "
56314|NCT02548533|"     The purpose of this study is to assess the efficacy of skin anesthesia using fractional laser     assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution     (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and     prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser treatment of acne     scars and traumatic scars.   "
56315|NCT02548520|"     In this study the investigators wanted to assess vitamin D status and possible consequences     of low plasma 25-hydroxyvitamin D levels in a population of healthy mothers and their     infants, in the community of Aarhus, Denmark.   "
56316|NCT02548507|"     Background :      Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower limbs     occurring during prolonged periods of rest, typically during the night. They may cause severe     pain and sleep disturbance, and are particularly common among older adults, though they can     occur in all decades of life. They are frequently unreported to physicians. To the     investigators' knowledge, no epidemiological studies have been conducted in Switzerland, but     in a general population survey carried out in the UK (n=233), the overall prevalence of NLC     was 37% and the disorder was more prevalent in older subjects (>80 years old: 54%). Of those     who experienced NLC, 40% had cramps three or more times per week and 6% nightly. Another     study performed in older US veterans (n=515) showed that 56% suffered from NLC.      The precise cause of these cramps is unclear. Most NLC occurring in adults appear to be     idiopathic, but potential contributing factors include low levels of certain minerals,     extracellular fluid volume depletion and prolonged sitting or inappropriate leg position     during sedentary activity.      Research question :      What are the prevalence and the main features of NLC in patients consulting primary care     physicians (PCPs) in Geneva, and how do PCPs treat this affection?      Primary objective :      To compute the prevalence of NLC in patients consulting PCPs in Geneva, explore its main     features (number, duration, severity and sleep disturbance) and assess how PCPs treat this     affection.      Study design :      Prospective observational study using questionnaire and daily log completed by patients.   "
56318|NCT02548481|"     Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients     survived with aftereffects, in particular aphasic disorders.      A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post stroke     had been worked out. After a meeting, 13 multidisciplinary experts have discussed, adjusted     and a new complete tool (BESTA) had been created in order to evaluate the different states of     aphasia.      The goal of this study is the validation and the standardization of this new BESTA tool.   "
56334|NCT02548260|"     Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no     treatment has been shown to be superior. The investigators wish to study the effectiveness of     syndactyly versus digital splint when comparing joint mobility. The investigators also wish     to study the effectiveness of finger compression in reducing edema and therefore allowing a     greater arc of motion.   "
56319|NCT02548468|"     This phase I trial studies the side effects and the best dose of donor lymphocyte infusion     when given together with reduced intensity conditioning regimen before partially matched     donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or Sezary     syndrome. Giving chemotherapy and low-dose total-body irradiation followed by high-dose     cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth     of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer     cells. Sometimes the transplanted cells from a donor can make an immune response against the     body's normal cells (called graft-versus-host disease). Removing the T-cells from the donor     cells and giving them before transplant may stop this from happening. Additionally, giving     tacrolimus and mycophenolate mofetil before and after transplant may also stop this from     happening.   "
56320|NCT02548455|"     The primary intent of this study is to assess the safety of the model 1457Q Quartet Left     Ventricular (LV) lead at 3 months in a patient population indicated for cardiac     resynchronization therapy.   "
56321|NCT02548442|"     Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose     Autism Spectrum Disorder in Early Childhood.   "
56322|NCT02548416|"     Atelectasis is common during and after general anaesthesia and a number of interventions have     been suggested in order to prevent their formation. The use of Positive End Expiratory     Pressure (PEEP) during general anaesthesia has in recent years been questioned.      The investigators hypothesize that the use of PEEP as a single intervention improves     oxygenation and prevents atelectasis as investigated by computed tomography compared to a     control group with zero PEEP.   "
56323|NCT02548403|"     Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal     visualization during colonoscopy is often limited by residual stool, bubbles, bile,     intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other     small lesions.Therefore, intestinal preparation is necessary to remove residual materials     prior to endoscopy.      A combined agent, low-dose PEG with ascorbic acid (PEG-Asc), is one low-volume solution     commonly used in Korea (Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea). However,     practitioners have noted an increased incidence of bubble formation with this preparation     method.      To the investigators knowledge, no previous study has assessed colon preparation in patients     administered simethicone.      The purpose of this study was to compare the quality of bowel preparation and compliance     between PEG-Asc and PEG-Asc with simethicone. The effectiveness of adding simethicone as an     antifoaming agent to improve bowel cleansing for colonoscopy was evaluated in terms of bowel     preparation scale and bubble score, and the compliance of both patients and endoscopists was     also investigated using a questionnaire.   "
56324|NCT02548390|"     This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107 administered     to subjects with advanced solid tumors. The study is designed to explore the safety, maximum     tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary clinical activity     of RXDX-107 and to define a recommended Phase 2 dose (RP2D)   "
56325|NCT02548377|"     The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the     risk of complications in patients undergoing resection of head and neck cancer and immediate     reconstruction with autologous free tissue transfer.      Remote ischemic preconditioning is a treatment, which is carried out by inducing brief     episodes of upper arm occlusion using an inflatable tourniquet.      Blood samples will be taken during the operation and postoperatively to evaluate the effects     of remote ischemic preconditioning. These blood samples will be analyzed for clotting     properties and markers of inflammation.      Furthermore, effects on the blood supply of the transferred tissue flap will be measured by     infrared thermography.      Effects on surgical complication rates will be obtained by clinical follow-up and patient     chart review.   "
56326|NCT02548364|"     To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma     levels of several prognostic biomarkers and on endothelial function after an anterior     myocardial infarction.   "
56327|NCT02548351|"     The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment     compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in     patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.   "
56328|NCT02548338|"     The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical     treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical     treatment using regular electric scalpel ; 2) surgical treatment using argon plasma     coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the     weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative     outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a     doctor using our standard clinical record and it will be measured using reliable parameters,     for exemple: if the investigators clinically detect a hematoma then we'll perform an     ultrasound to take the real extension; if the investigators clinically pick an infection     we'll measure the extension of the hiperemia; and if the investigators clinically pick a     seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure     (centimeters) the terminal damage caused on the surgical specimens (samples) using the     microscope.   "
56329|NCT02548325|"     The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental.     Also, describe the stage of the disease, and whether if they are under medical treatment or     not.   "
56330|NCT02548312|"     Financial ties with industry are common among doctors, academics and institutions. This trial     aims to investigate the influence of different types of industry-linked activities on     readers' perceptions of clinical reviews. Two clinical reviews have been selected on medical     topics and study participants (practicing doctors) will be sent one review each. The reviews     will be identical except for the inclusion of one of four different permutations of competing     interest statements. Participants will be asked to rate the one review they are sent based on     the study outcomes (confidence, interest, importance and likeliness to change practice). The     study focus is on educational articles as these are intended to guide patient care and convey     the authors' interpretation of selected data.   "
56335|NCT02548247|"     Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel     motor function in subjects with constipation.   "
56337|NCT02548221|"     The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly     understood. Improvement of the heart and lung function may contribute to the dyspnea relief.     But there is no data support this phenomenon. Transthoracic echocardiogram (TTE) is a     non-invasive viewing of the heart, which can quickly assess the heart function through     real-time images. The investigators performed thoracentesis on patients with large-volume     pleural effusions, and utilized TTE to access the change of heart and lung function before     and after this medical procedure.   "
56338|NCT02548208|"     The study is a single-center, double blinded, randomized controlled trial aimed to     investigate the effects of focused extracorporeal shockwave therapy (fESWT) on Delayed Onset     Muscle Soreness (DOMS) of the non-dominant biceps brachialis muscle in healthy voluntary     adults.   "
56339|NCT02548195|"     To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus     capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic     cholangiocarcinoma (ICC) -- a randomized control study.   "
56398|NCT02547428|"     This is a Phase IIb, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover     study to evaluate safety, efficacy, and duration of efficacy of CTN SR BID target total daily     dose (TDD) 400 mg compared with placebo in adults with ADHD.   "
56340|NCT02548182|"     The investigators are planning to conduct a pilot RCT of young obese population to evaluate     the effect of smartcare with or without financial incentives for 12 weeks. Participants will     be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial     incentives group.   "
56341|NCT02548169|"     The primary objective is to confirm clinical safety and feasibility of combining the     antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid,     oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine     in patients with pancreatic cancer.      The secondary objectives of this trial are to determine preliminary clinical efficacy based     on response rates, overall survival and progression free survival compared with historic     control, and surgical conversion rate as defined as percent of locally advanced     (unresectable) patients achieving resectability within 6 months of treatment initiation.     Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune     activating events post-vaccination and to correlate clinical response with acquired immune     responses.   "
56342|NCT02548156|"     The aim of this study is to assess the impact of formulation differences on fluoride     retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and     comparing between treatments the concentrations of fluoride and calcium ions in saliva over     60 minutes after a single brushing with US marketed fluoridated dentifrices and following a     dietary acid challenge post 60 minutes of brushing with study treatment.   "
56343|NCT02548143|"     The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive     bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have     inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who     are undergoing elective surgical or other invasive procedures. Administration of LR769 will     be performed just prior to surgery/procedure and will be repeated during and after the     surgery/procedure to achieve and maintain adequate hemostasis as determined by the     investigator's judgment.   "
56344|NCT02548130|"     The goal of this observational study was to evaluate the impact of the adoption of the MELD     system to prioritize patients on the waiting list for OLT on survival for 700 consecutive     liver transplantations. Survival was evaluated on the waiting list, one month, and one year     after the transplantation. Another goal was to look at blood losses and transfusion     requirement after the adoption of the MELD score. The hypothesis was the MELD system will     ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses and     transfusions could be worse with the MELD system.   "
56345|NCT02548117|"     Hypogonadism (low testosterone) is becoming an increasingly recognized problem that affects     numerous men in the United States. Symptoms may be always feeling tired, lower sex drive, and     loss of muscle mass. Treatment typically involves testosterone in either injections or a     topical gel form.      However, administration of testosterone is not without side effects of its own. Testosterone     supplementation therapy is known to cause a variety of side effects including high blood     pressure and high lipids (fats) and an increased proportion of red blood cells. Side effects     of increased red blood cells can include an increased risk of developing a blood clot.      The increase in the red blood cells is related to dihydrotestosterone (DHT - a male sex     hormone) activity. It is normal for the testosterone to become DHT. DHT has various effects     on the body including growth of the prostate gland, baldness, and others and DHT levels have     been linked to elevated red blood cell counts in men on testosterone.      Finasteride is an FDA approved medication used in the treatment of benign prostatic     hypertrophy (BPH) in men with enlarged prostate to improve symptoms and to reduce the risk of     the need for surgery. Finasteride may prevent elevations in or reduce elevated red blood cell     levels in men on testosterone.   "
56346|NCT02548104|"     Recently, more distal approach to femoral nerve branches (saphenous) in the adductor canal in     the medial compartment of the thigh have shown to provide comparable anesthesia and analgesia     without quadriceps muscle weakness than traditional femoral nerve blocks (FNB) after total     knee arthroplasty (TKA). Adductor canal block (ACB) has the unique advantage of providing     localized analgesia to the peripatellar and intra-articular aspects of the knee joint without     reducing the patient's ability to perform a straight leg raise. However, it does not     adequately address the incisional pain component on the anterior surface of the knee     innervated by anterior femoral cutaneous nerve. This pain may be improved by addition of the     anterior femoral block (AFB). Additionally, the ACB does not provide analgesia to the     posterior aspect of the knee, which is commonly moderate to severe after surgery. This pain     may be decreased by addition of the genicular block, also known as the iPACK block     (interspace between the popliteal artery and the capsule of the knee). There is no study that     has evaluated the potentially analgesic benefits of the AFB or the iPACK block combined with     ACB after TKA. Therefore, the investigators designed this randomized, prospective, and     double-blinded study to assess our hypothesis that the addition of the AFB and/or iPACK block     to the ACB will improve analgesic effects, decrease pain scores, deceased opioid requirement,     and as well as facilitate early recovery and improve patient satisfaction with pain     management in patient after TKA.   "
56366|NCT02547844|"     To compare the lipidomic profile in patients with HIV-1 with viral suppression changing     efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir     (Eviplera®) versus a group of patients that continue with Atripla®.   "
56348|NCT02548078|"     The purpose of this study is to assess the safety and reactogenicity of a single IM dose of     the ChAd3 EBO-Z vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years,     separately Considering the risk of exposure to Ebola and the potential (based on animal data)     for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all     children in the study will receive the investigational ChAd3 EBO-Z vaccine. The children in     the Group EBO-Z/ MENACWY-TT will receive the investigational ChAd3-EBO-Z vaccine at Day 0 of     the study, whereas the children in the Group MENACWY-TT/ EBO-Z will receive Nimenrix at Day 0     (as a control). At Month 6, the children in the Group MENACWY-TT/ EBO-Z will receive the     investigational ChAd3-EBO-Z vaccine (provided that no safety concerns are raised), whereas     the children in the Group EBO-Z/ MENACWY-TT will receive Nimenrix..   "
56349|NCT02548065|"     The present randomized, controlled double blind trial aims to evaluate the efficacy and     tolerability of balneotherapy with mineral water named Debole of Vetriolo in 100 patients     with primary Fibromyalgia Syndrome (FS).   "
56350|NCT02548052|"     GSK2981278 is a highly potent and selective inverse agonist of retinoic acid receptor-related     orphan receptor gamma (ROR gamma) that is under development for topical treatment of plaque     type psoriasis suitable for topical therapy.      This is the first study to administer GSK2981278 to subjects with psoriasis. This     proof-of-concept study will evaluate the safety, tolerability and initial efficacy of a range     of concentrations of GSK2981278 ointment with repeated topical applications in adult subjects     with psoriasis. Results of this study will provide first clinical information on the drug's     safety and efficacy in psoriasis and inform the selection of concentration of GSK2981278     ointment to be evaluated in subsequent clinical studies.      This is a Phase 1, single center, test field-randomized, vehicle- and positive- controlled,     subject- and evaluator-blind study. All subjects will receive all 6 treatments on 6 test     fields, for intra-individual treatment comparison. For every subject, the manner of     assignment of each treatment to a particular test field will be according to a randomization     scheme. Thus, the test fields within each subject, and not the subjects themselves, will be     randomized.      The study will consist of screening, followed by a treatment period of 19 days, and a     follow-up visit at Day 27 (+/-2) for subjects who will consent for biopsy. During the     treatment period, subjects will receive all of these treatments: GSK2981278 ointment 0.03%     weight by weight [w/w], 0.1% w/w, 0.8% w/w, 4% w/w, GSK2981278 vehicle, and betamethasone     valerate 0.1% cream. The test fields on which these treatments will be applied will be     identified on stable plaque(s) on the upper extremities, thighs and/or trunk. A blinded     evaluator (an investigator or designee) will perform the measurements and assessments whereas     an unblinded study staff member (not an evaluator) will perform biopsy collection.   "
56351|NCT02548039|"     The purpose of this study is to match the genetic component and clinical attributes of     anovulatory patients with response to clomiphene treatment.      By improving our understanding on patient-specific clomiphene response will allow     optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.   "
56352|NCT02548026|"     The purpose of this study was to determine the effects of low vs. high eating frequency (EF)     on biomarkers of health and subjective appetite.   "
56353|NCT02548013|"     This study is to compare the maternal and neonatal outcomes in the patients with PPROM who     are managed at home versus those managed at hospital, half the patients will be managed at     home and the other half will be managed inpatient.   "
56354|NCT02548000|"     This study aims to verify the effects of resistance training on neuromuscular, vascular and     functional adaptations of elderly diabetics type 2. Half of participants will be the     intervention group that will perform resistance training, while the other half will be the     control group that will perform stretching sessions.   "
56355|NCT02547987|"     The purpose of this study is to determine whether the combination of docetaxel and     carboplatin is an effective treatment for patients with triple negative breast cancer.   "
56356|NCT02547974|"     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the     investigational GSK Biologicals' GSK3277511A vaccine in adults   "
56357|NCT02547961|"     The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion     for advanced HER2 positive breast cancer.   "
56358|NCT02547948|"     The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T     Cells infusion for B Cell Lymphoma.   "
56359|NCT02547935|"     The purpose of this clinical research study is to determine whether dapagliflozin alone or in     combination with saxagliptin can decrease albuminuria and improve glycemic control in     patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned     to randomize a total of 450 patients (150 patients per treatment arm).   "
56360|NCT02547922|"     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment     regimen of two doses of anifrolumab versus placebo in adult subjects with active     proliferative lupus nephritis (LN).   "
56361|NCT02547909|"     Endometriosis is defined as the presence of endometrial glands and stroma outside of the     uterus.Endometriosis affects 5%-15% of women in the reproductive age. Deep endometriosis is     mostly defined as a single endometrial nodule, located in the vesico-uterine fold or close to     the distal 20 cm of the large bowel. Current guidelines recommends that laparoscopy with     histology should be done to diagnose endometriosis. Probe-based confocal laser endomicroscopy     (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo     cellular-level imaging, a concept known as optical biopsy. considering the rectal bleeding     that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen     at standard endoscopy (personal data), we hypothesized that there might be histological     architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.   "
56362|NCT02547896|"     It will be evaluated the clinical efficacy of Diclofenac 50mg (NSAID) compared to its     association with Codeine 50mg (opioid) administered in 50 patients requiring extraction of     two third molars. After assessing the research parameters, a comparative data analysis, along     with the proper application of statistical tests, will provide the basis for an evaluation of     both efficiency medications used.   "
56363|NCT02547883|"     In patients ≥ 75 years, there is no evidence that statins in primary prevention are     associated with a decreased mortality and recent US recommendations consider statins in     people only between 40 and 75 years. Moreover, statins are associated with numerous side     effects impacting quality of life of those people and represent a high cost for the French     healthcare system.      The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin     cessation in people ≥ 75 years treated in primary prevention.   "
56364|NCT02547870|"     The purpose of this study is to compare the single‐dose pharmacokinetics of rilpivirine (RPV)     after intramuscular (IM) injection of rilpivirine long‐acting parenteral formulation (RPV‐LA)     and 'aged' RPV‐LA, in healthy adult participants.   "
56378|NCT02547688|"     Preliminary data show that high flow nasal air has been shown to reduce promote heat exchange     due to evaporation of nasal mucus by the air flow resulting in heat loss. It is unclear     whether unidirectional nasal airflow is well tolerated in healthy individuals. The central     hypothesis of this proposal is that dry high flow nasal air will be sufficiently tolerated in     healthy adults.   "
56379|NCT02547675|"     To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC     who have been treated previously with EGFR directed therapy and have evidence of a T790M     mutation (T790M+).   "
56380|NCT02547662|"     This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work     in treating patients with previously treated multiple myeloma or plasma cell leukemia.     Biological therapies, such as pomalidomide and dexamethasone, use substances made from living     organisms that may stimulate or suppress the immune system in different ways and stop cancer     cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone     together may be more effective in treating multiple myeloma.   "
56367|NCT02547831|"     This is a prospective, multicenter observational study under the umbrella of the ISG (Italian     Sarcoma Group) evaluating local progression-free survival at 3 years of patients affected by     extra-abdominal primary fibromatosis managed with front-line conservative approach and     treated only in case of demonstrated progressive disease.      All patients included will be placed on wait and see approach and then shifted to treatment     in case of documented radiological progressive disease.      For patient primarily evaluated for suspected desmoid tumor, a core-needle biopsy (eventually     under CT/ultrasound guide) will be obtained for histological diagnosis and mutational     analysis of CTNNB1 exon 3 (gene encoding Beta-catenin). If incisional biopsy or surgical     procedure has done elsewhere, samples will be requested for histological confirmation and     mutational analysis (centralization at the investigators Institution).      In case of progression at 3 months, defined as tumor growth documented radiologically (by     contrast enhanced MRI) by Response Evaluation Criteria in Solid Tumors (RECIST), administered     treatments will be proposed and then registered in the clinical database.The choice of the     treatment and eventually the possibility of continuation of  surveillance only will be at     the discretion of Institution's Multidisciplinary Sarcoma Committee or as part of clinical     trials with the consent of patient.   "
56368|NCT02547818|"     This is a global Phase III, randomized, double-blinded, placebo-controlled study for subjects     with evidence of early AD. The protocol is designed to determine whether ALZT-OP1 combination     treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive and     functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).   "
56369|NCT02547805|"     Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for     reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney     stones.   "
56370|NCT02547792|"     This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this     study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent     seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27     subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects     (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be     enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and     immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated     through 1 year post vaccination.   "
56371|NCT02547779|"     The administration of intravenous fluids is ubiquitous in the care of the critically ill.     Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte     compositions including a range chloride concentrations. Recent studies have associated     solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and     renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased     mortality but no large, randomized-controlled trials have been conducted. SMART-SURG will be     a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from     the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The primary     endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment     (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at     discharge).   "
56372|NCT02547766|"     Heart failure remains a major cause of morbidity and mortality. Many patients with heart     failure receive support from a left ventricular assist device (LVAD) at some point in the     course of their disease. Some of these LVAD patients experience a durable recovery after     ventricular unloading with an LVAD, which may be associated with inhibition of inflammatory     cytokines. This small pilot study aims to determine the biologic and clinical efficacy of an     interleukin-1 receptor antagonist (Anakinra) at inducing myocardial recovery in patients     supported with left ventricular assist devices.   "
56373|NCT02547753|"     The literature is rich in studies that explore the type and frequency of oral abnormalities     in transplanted recipients, but it is scarce in studies that provide scientific evidence on     the risk of complications after invasive interventions on those patients. Within this     context, the aim of our study is to evaluate the post-exodontic socket repair in kidney     transplant recipients compared to a control group and see if some indicators in the     population of transplanted people (complete blood count, cluster of differentiation 4 (CD4+)     level, serum concentration of immunosuppressive drugs) can help to provide for the host     response face a invasive procedures. Therefore, 30 kidney transplant recipients over six     months and 30 healthy non immunosuppressed adults will be submitted to a maximum of 3 simple     extractions, always by the same surgeon. Laboratory tests will be evaluated preoperatively     and include: blood count and coagulation - for both groups - and urea, creatinine, CD4+ and     cluster of differentiation 8 (CD8+) lymphocytes T and serum levels of immunosuppressive drug     - only for the study group. Researchers will evaluate the patient in the postoperative 3, 7,     21, 30 and 60 days. The presence, or absence, of post-exodontic complication and delay, or     not, of socket repair will be the results of interest in this study and will be compared     between the groups. The data will be evaluated by ANOVA, chi-square. Logistic regression     analysis will be used to evaluate the influence of modifying factors such as smoking and     presence of diabetes.   "
56374|NCT02547740|"     Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a     new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is     getting worse. There is scientific evidence that the macula, the central part of the retina,     can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very     prevalent and is often missed using conventional clinical tests.      Relatively little is known about progression of early glaucoma damage and its effects on the     macula. This project investigates the nature of progressive damage to the macula and proposes     new methods to improve accuracy to detect clinically significant progression.The study will     evaluate the nature of damage to the macula's structures through OCT imaging and eye function     via visual field tests.   "
56375|NCT02547727|"     A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever     received primary rabies vaccination could improve their immune response to this kind of     vaccine.   "
56376|NCT02547714|"     The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16     based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response     to cyclosporine A.   "
56428|NCT02547038|"     Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy     remained unanswered.   "
56383|NCT02547623|"     The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40     years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion     criteria will be randomized to 1 of 2 treatment groups        -  A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone,          equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;        -  Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times          daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp          biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and          specular microscopy endothelial cell count.   "
56384|NCT02547610|"     In this prospective study, we will recruit newly diagnosed esophageal cancer patients and     perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be     added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.   "
56385|NCT02547597|"     There are few data regarding anti-anginal effects between beta-blockers with and without     vasodilating property. Beta-blocker without vasodilating property is generally known to have     unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared     carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina     pectoris.   "
56386|NCT02547584|"     This pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in     female patients with paroxysmal and persistent atrial fibrillation (AF).   "
56387|NCT02547571|"     The purpose of this study is to compare diet, type of bowel preparation and time of     colonoscopy to determine if one method is better than the other and, if they are the same,     identify the one which is the most convenient for the patients.   "
56388|NCT02547558|"     To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled     indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011     groups.      Measurements on a single day before and after 60 and 120 minutes of indacaterol will include     arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in     exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated.     Cardiac output will be directly measured by bio-impedance.   "
56389|NCT02547545|"     This is a cohort study. This study is to develop a predictive model of the side effects after     chemotherapy, exploreing the potential risk factors of the side effects such as     myelosuppression and chemotherapy realted vomit after the chemotherapy, so that it could help     to alleviate patients' fear and anxiety about the side effects and the toxicity of     chemotherapy. The potential risk factors were measured at baseline.   "
56390|NCT02547532|"     In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our     aim is to determine the total and specific bacterial and viral load in sputa from patients     with COPD due to AATD and to correlate these findings with cellular, biochemical and     immunological characteristics of sputa. These quantitative data obtained from sputum will be     analyzed in the context of the clinical and physiological parameters of the patients.   "
56391|NCT02547519|"     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta     cells within the pancreatic islets of Langerhans. This process is identified by circulating     islet autoantibodies to beta cell antigens, and is mediated by a lack of immunological     self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or     periphery in a manner that deletes autoreactive effector T cells or induces regulatory T     cells. Immunological tolerance can be achieved by administration of antigen under appropriate     conditions. Administration of oral insulin in islet autoantibody-negative children who are     genetically predisposed for T1D offers the potential for inducing immunological tolerance to     beta cells and thereby protect against the development of islet autoimmunity and T1D.   "
56392|NCT02547506|"     The central goal of the proposed study is to generate essential pilot data necessary to     support an established line of research leading to future extramural grant submissions. The     aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and     gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD) who     participate in boxing on a regular basis, (2) individuals with PD who participate in exercise     other than boxing on a regular basis and (3) healthy controls of the same age who exercise on     a regular basis and 2) to examine the relationship between CRF and motor symptoms of PD     (bradykinesia, tremor and postural instability). Forty-five participants (15 for each group)     who participate in exercise on a regular basis (at least 120 minutes of exercise per week for     the past 3 months) will be recruited for this cross-sectional study. In a single testing     session, participants will perform the following tests: (1) clinical performance measures and     (2) a CRF assessment. A one-way ANOVA with appropriate post hoc tests will be used to examine     differences in dependent variables across the three exercise groups. Relationships between     CRF and clinical performance measures will be evaluated with Pearson's correlation     coefficients.   "
56393|NCT02547493|"     Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more     efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral     response) in RA patients treated with abatacept, biotherapy targeting T-cells? The     investigator propose to conduct a prospective, multicenter (11 centers), randomized,     open-label study.      The patients are going to be randomized in 2 groups: patients of the first group will be     vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®) whereas patients of the     second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).   "
56394|NCT02547480|"     The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and     efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver     predominant mCRC by chemoembolization.   "
56395|NCT02547467|"     The aim of this study is to assess the causes of death in patients with septic shock in     French intensive care units. It is an epidemiologic and descriptive study .   "
56396|NCT02547454|"     This observational trial will examine the efficacy and safety of Mircera for renal anemia in     participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by     treating physician and followed for approximately 36 months.   "
56397|NCT02547441|"     This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel     compared to vehicle gel in subjects with severe papulopustular rosacea.   "
56399|NCT02547415|"     Medically unexplained chronic pain - without identifiable somatic origin - is yet an     insufficiently known and explored field in children and adolescents by international clinical     works. This research aims to characterize somatic, psychological, psychopathological and     environmental (particularly attachment styles and family functioning) processes trough an     observational study with three pain management centers.      The study concerns children and adolescents from 7 to 17 years old, suffering of medically     unexplained chronic pain and their parents who are referred to a pain center. It is composed     of a somatic, psychological and family functioning assessment on the one hand and     psychopathological and attachment evaluation on the other hand.   "
56400|NCT02547402|"     This is an exploratory study in a small, well controlled group of healthy subjects to explore     the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe).   "
56401|NCT02547389|"     Improving medical compliance and health-related quality of life (HRQoL) among people with     epilepsy (PWE) has become the focus of various treatment programs and behavioral     interventions which continue to be challenging to both patients and health care     professionals.      In order to design an effective intervention on the management of epilepsy, the drug     management of epilepsy by community health workers was evaluated.   "
56402|NCT02547376|"     Soft tissue sarcomas (STSs) are a rare group of cancers that can arise in any 'soft' tissue     but commonly involve muscles, fat and nerves. Even following surgery and radiotherapy over     50% of tumours will recur or spread and at present, there is no reliable test that allows     doctors to predict in which patients this will occur.      DNA that is not inside cells (cell-free or cfDNA) is present in very small quantities     circulating in blood. In cancer patients some of this cfDNA comes from cancer cells. Analysis     of cancer-derived cfDNA in patients with other cancers has shown that the quantity and     characteristics of cfDNA changes with stage of disease and treatment. The researchers plan to     investigate the abundance and persistence of cancer-derived cfDNA in STS patients at various     stages of disease to investigate the potential role of these characteristics as biomarkers.      Selection of the genetic characters to be tracked in the patients' cfDNA is an important     consideration. An established hallmark of a cancer cell is the ability to undergo an     unlimited number of cell divisions. In normal human cells protective structures on the ends     of chromosomes called telomeres provide a mechanism to limit the number of times a healthy     cell can divide. This limitation has to be overcome in cancer cells for a tumour to form.     This occurs by the activation of one of two telomere maintenance mechanisms (TMM) - either an     enzyme called Telomerase or a mechanism known as Alternative Lengthening of Telomeres (ALT).     In many sarcomas the activation of either TMM is associated with genetic changes (mutations)     in a small number of genes. As these mutations are not present in normal cells but mark an     essential feature of cancer cells (and their capacity for unlimited cell division) they are     likely to be reliable markers of the presence of STS cells.      The investigators plan to develop sensitive, quantitative assays to detect TMM associated     mutations in tumour derived cfDNA in the blood of patients with STSs, and track these     mutations overtime. They will establish the amount of cancer-derived cfDNA in STS patients at     the time of surgery, and persistence of this cfDNA during follow up visits following tumour     resection and in the events of local tumour recurrence or spread (metastatic disease). Once     these basic parameters are established analysis will be broadened to include other genes that     are commonly mutated in STSs with a view of identifying other genetic characteristics that     may also aid identification of patients at high risk of recurrence or spread. In summary all     of the assays described above should facilitate better monitoring of patients with STS, and     allow earlier treatment if STS recurs following surgery.   "
56403|NCT02547363|"     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with     vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive     days as field treatment.   "
56404|NCT02547350|"     The purpose of this study is to evaluate the efficacy of prophylactic intravesical     chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder     recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).   "
56405|NCT02547337|"     Type 1 diabetes is the major type of diabetes in the young. The pathophysiology still needs     clarification in order to reach feasible means of preventing the disease. This study aims in     defining the differences in pancreatic and intestinal blood flow between subjects with and     without type 1 diabetes and validating the methodology to achieve this. Earlier animal     studies have demonstrated changes in pancreatic islet blood flow using microspheres. The aim     of this study is to test and validate a method for the assessment of islet perfusion in     humans using molecular imaging. The investigators hypothesize that glucose-stimulated     pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this     increase is mostly suppressed in subjects with type 1 diabetes.      Positron emission tomography (PET) is a non-invasive imaging technique, which can be used to     study flow and metabolism of different organs. Using radiowater ([15O]H2O) and PET, cellular     perfusion can be measured directly and noninvasively. Recently, diffusion weighted magnetic     resonance imaging (DWI) has also been applied as a complimentary method for the assessment to     quantitate changes in pancreatic blood flow.      In the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two     separate days. Pancreatic and intestinal perfusion are first measured with [15O]H2O and     combined PET/magnetic resonance imaging before and 5 and 15 minutes after intravenous glucose     infusion. On the second day, PET imaging is replaced by dynamic DWI conducted in the same     time schedule and with intravenous glucose stimulation.   "
56407|NCT02547311|"     Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles     with their diabetes management resulting in worsening diabetes health and increased     complications. This population's declining well-being occurs during a time when they should     be at their healthiest and enjoying multiple exciting life transitions. Their worsening     diabetes management is complicated by the fact they are also learning how to become more     independent from their family in preparation for eventually leaving home. Furthermore, the     number of people under 20 years of age diagnosed with T1D has increased dramatically over the     past 10 years giving rise to increased concern about providing care to this population.      The Team Clinic Intervention is an innovative clinical care approach to address the medical     and developmental needs of adolescents with T1D and their families. A group medical     appointment format will be used for routine diabetes clinic visits in middle school and high     school adolescents with T1D. Parents of these patients will be participating in their own     group during these clinic visits. The Team Clinic model incorporates developmentally tailored     peer support and novel learning tools, (e.g. games, physical activity, and/or interaction     through Internet resources, e.g. blogs, forums) into the shared medical appointment design.      The goal of Team Clinic Intervention is to improve medical and psychological outcomes in     adolescents with T1D and their parents. The study will investigate, in a randomized     controlled trial, the efficacy of a novel clinical care model that addresses the unique     developmental strengths and weaknesses of the T1D adolescent population. The Team Clinic     format streamlines clinical care delivery to this often-challenging patient population     without placing additional burden on youth, families, or clinics because the intervention     will be completed during routine diabetes care visits. Moreover, the Team Clinic approach     maximizes the benefits of peer support by delivering care in a group format to address the     sense of isolation that teens and families coping with chronic illness often feel.      If successful, the Team Clinic Intervention will not only positively impact adolescents with     T1D and their families, but it could be used as a model of care for other adolescents with     chronic medical conditions struggling to remain involved and invested in their medical care.     Team Clinics may be one approach to successfully engaging adolescents in their diabetes care     prior to their transition away from home, which will help them remain invested and active in     their medical care through adolescence and young adulthood.   "
56429|NCT02547025|"     In this study, the investigators develop a personalized treatment according to culture-guided     antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori     infection.   "
56430|NCT02547012|"     From the profiles of antibiotic susceptibility data following eradication therapy,     tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the     rescue treatment.   "
56408|NCT02547298|"     Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic     procedure involving cystoscopy (a lighted scope is used to look inside the bladder) under     anesthesia will be approached to participate in the study. Once prospective study subjects     are consented, they will be requested to complete the study questionnaires.      At the time of the procedure, during the cystoscopy, patients will undergo hydrodistension     (stretching the bladder with fluid). Photographic images of the bladder will be collected, to     be later analyzed by examiners. Patients who have positive findings for interstitial cystitis     during cystoscopy with hydrodistension, will be notified of the findings after the procedure.      They will be asked to fill out an additional, previously completed questionnaire at the time     of a follow-up visit, during a phone interview or responding to the questionnaire via a     secure web site. These patients will be treated for interstitial cystitis by their primary     providers as clinically indicated.   "
56409|NCT02547285|"     The proportion of people aged 60 and over in the French population has increased from 18% in     1970 to over 22% in 2010.      One major problem in the elderly is falling. About half of these falls cause a minor injury     and between 5% and 25% will cause a more serious injury such as a fracture or a sprain     (Alexander et al., 1992; Nevitt et al., 1991).      It therefore seems essential to study the locomotion of seniors to limit the maximum risk of     falling into a public health measure.      Two factors may be involved:        1. The first corresponds to factors related to natural aging topics        2. The second is the environment that is a real problem for seniors (Rolling showers,          presence of works ....) And especially the port of inappropriate footwear.      Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this     parameter that will be highlighted in our study.   "
56410|NCT02547272|"     Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A     methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus     bacteremia with are due to the strain isolated in the nasal level. However, as part of a     study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic     orthopedic devices have been linked to nasal carriage . Outside of exogenous infections,     intestinal colonization with S. aureus could be an alternative source of endogenous     infections with the waning of orthopedic surgery. In the general population, considering that     about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the     intestine However the proportion of exclusive intestinal porting is not well known .      This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It     will better clarify the relationship between nasal and rectal ports and the risk of     developing an infection.   "
56411|NCT02547259|"     Currently there is uncertainty on how schizophrenic patients feel pain. Pain has several     components including cognitive behavior which allow humans to perceive it as a negative     emotion. It is difficult to say precisely what are the differences in cognitive processing     between the emotional component of pain and painless another negative emotion (eg fear).     However, pain and negative emotion have some neural networks together and there are many     common ways between emotional processing (pain or negative) and storing information (limbic     system).   "
56412|NCT02547246|"     Bulimic patients suffering from binge eating or craving a pressing need to eat, with a     sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may     be considered appropriately by using paradigms developed in the framework of embodied     cognition theories.      In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for     food in these patients, as measured by reaction time.      Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated     transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to     the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among     bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more     than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms     have not yet been explored.   "
56413|NCT02547233|"     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with     vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days     as field treatment.   "
56414|NCT02547220|"     To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated     rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the     proportion of subjects with new or worsening transplant glomerulopathy (TG) at 6 months after     treatment initiation.   "
56415|NCT02547207|"     The purpose of this study is to characterize left ventricular acute hemodynamic and     electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint     Pacing (MPP) settings, and assess the relationship between electrical activation patterns and     hemodynamic measurements during these pacing settings.   "
58147|NCT02524470|"     To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the     in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and     console. The VSP System will be incorporated into the study site's Information Technology     infrastructure.   "
56416|NCT02547194|"     The health-related quality of life questionnaire EQ-5D has been collected in connection     with several interventional and observational studies where the no-touch vein harvesting     technique in CABG has been used. The results of the questionnaires will be compiled and     reported in this study.   "
56417|NCT02547181|"     This Study is being done because the investigators would like to know if pain and hand     function after having a boxer's fracture differs between being treated with supportive     splinting or without splinting, but with behavioral modifications.   "
56432|NCT02546986|"     The purpose of this study is to determine whether the combination therapy of CC-486 (oral     azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab     alone in subjects with previously treated locally advanced or metastatic non-small cell lung     cancer.   "
56444|NCT02546830|"     The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver     automatically oxygen in the post anesthesia care unit in a patient population admitted for     major abdominal and thoracic surgery.      The investigators' hypothesis is that FreeO2 system will provide a better control of the     oxygen saturation and reduce postoperative hypoxaemia.   "
86860|NCT02149121|"     This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10,     Rituxan and MabThera in Patients with Rheumatoid Arthritis.   "
56418|NCT02547168|"     Lung resections for pulmonary malignancies offer the best chance of survival for patients,     but these procedures carry a significant burden of post-operative morbidity and mortality.     Patients are particularly at high risk for post-operative atrial fibrillation (a condition     involving irregular heart rhythm). Atrial fibrillation with symptoms can increase the risk of     stroke - a blockage in a major blood vessel in the brain, which can potentially result in a     disability or even death. The objective of this study is to establish the feasibility of     using ambulatory heart rate monitoring to determine the total incidence of atrial     fibrillation in the peri-operative period before and after anatomic lung resection for     malignancies. The study will also investigate the correlation between atrial fibrillation and     rates of stroke and other adverse events, as well as serve to identify the patients that are     at a higher risk of developing atrial fibrillation.   "
56419|NCT02547155|"     The purpose of the study is to compare the risk of being unable to urinate shortly after     surgery, also called acute post-operative urinary retention (POUR) between spinal and general     anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary     incontinence surgery.   "
56420|NCT02547142|"     Palliative care physicians and nurses are trained to help reduce suffering and improve     quality of life in patients under their care. Their services also include other components     such as referral to dietitians, social workers and community resources, to assist patients in     their homes. In addition to this, they may also administer interventions to make patients     more comfortable, assisting them and their families in making important decisions and     providing support, during that time.      At present, palliative care is provided to esophageal cancer patients on an as-needed basis,     through the referral of a heath care professional or the patient's request. This study aims     to assess the impact of the integration of early palliative care combined with appropriate     medical care in the metastatic esophageal cancer population, so that patients can benefit     from these services at an earlier stage. It is hoped that this will improve quality of life,     symptom management, depression and anxiety, as well as survival.   "
56421|NCT02547129|"     What is the difference in the outcomes of patients treated with an articulating antibiotic     spacer versus a static articulating spacer in the setting of two stage exchange for infected     total knee arthroplasty?   "
56422|NCT02547116|"     Methicillin-susceptible (MSSA) and Methicillin-resistant (MRSA) Staphylococcus aureus (SA)     are two of the most important infectious pathogens in CF, with 69% of CF patients having lung     infection with MSSA or MRSA in the last year. Wolter and co-workers recently demonstrated     that a specific morphologic subtype of MSSA and MRSA, small-colony variant Staph aureus     (SCV-SA), is associated with greater decline in lung function and worse clinical outcomes.     SCV-SA is already recognized for its ability to contribute to persistent infection, likely     due to SCV-SA's ability for intracellular growth, as well as its increased antibiotic     resistance compared to normal-colony SA. To investigate the epidemiology and clinical     significance of SCV-SA in CF, and explore the hypothesis that SCV-SA may require unique     antibiotic treatment strategies to optimize clinical response, the investigators will perform     the following:        1. Characterize the epidemiology of SCV-SA infection in both an adult and pediatric CF          population and investigate the clinical significance of SCV-SA infection in CF by          comparing clinical characteristics and outcomes of CF patients with SCV-SA compared to          those with to normal-colony MSSA/MRSA.        2. Characterize the unique microbiologic characteristics of SCV-SA infection in CF by          evaluating antibiotic susceptibility profiles and molecular characteristics of SCV-SA in          a two large CF patient populations.        3. Perform a 16-patient pilot study of a novel treatment for SCV-SA infection in CF,          utilizing low dose rifampin in combination with standard anti-SA antibiotics.      These investigations will delineate the role of SCV-SA as a pathogen in CF and provide     guidance to optimize treatment strategies of MSSA/MRSA CF lung infection.   "
56423|NCT02547103|"     This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine     gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal     saline) with aseptic technique in prevention of PD-related infection. It is a pilot study,     double-blind, stratified randomized controlled trial. Participants will be randomized to     three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be     followed at 1,3,6,9, and 12 months or until PD-related infection, catheter removal, or death.     The primary outcome is PD-related infection. Secondary outcomes are safety, adverse events     related to treatments such as skin irritation, rash etc. Other outcomes are hospitalization     due to PD-related infection, technical failure,change of modal of dialysis, adherence to     medication, death due to PD-related infection. Costs include providers and patients expenses.     Utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version.     The results of this study are anticipate nephrologists and health care professional involving     to PD in decision making for a plan to prevent PD-related infection. In addition, the results     will lead to clinical guideline development a prevention of PD-related infection.   "
56424|NCT02547090|"     Background:      Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of     complications and mortality. Complication rates have been reported as high as 45%, and     infection rates typically reported at 15%. Efforts to improve efficiency by reducing     operative time and blood loss could decrease these risks. The purpose of this study is to     investigate the impact of utilizing two attending surgeons on blood loss, operative time, and     complications in this population.      Methods:      This is a prospective, matched cohort analysis with a consecutive series of patients with CP     who underwent PSF, with two attending surgeons, in 2012. These are matched with a control     group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA,     or RN-FA. The groups are compared using paired Student T-tests and chi square tests     (significance set a p<0.05).   "
56426|NCT02547064|"     The GlideScope® videolaryngoscope usually visualize glottis better than the conventional     laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of     endotracheal tube, however, is challenging.      The goal of this study was to determine which of two stylet (70° vs 90°) was better, as     determined by time to intubation.   "
56427|NCT02547051|"     The purpose of this study is to see whether participants with persistent developmental     stuttering (PDS) who report fluctuational severity on a day to day basis of can achieve a     more normalized fluency of speech by identifying dietary allergen responses and subsequently     eliminating these dietary triggers from their daily consumption.   "
56433|NCT02546973|"     A national study of a three year cohort consisting of all patients diagnosed with anal cancer     in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient     registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All     out- and inpatient visits with diagnoses, admission dates and discharge dates will be     requested including.      Patient documentation from the concerned hospitals will be collected and data on the details     of the treatment collected retrospectively in a standardised fashion using a clinical record     form.      Comorbidity will be calculated using data from the Patient Registry using all main and     co-diagnoses 2 years prior and then at least two years after treatment cessation.      Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years     after index treatment.   "
56434|NCT02546960|"     The purpose of this study is to evaluate the safety, tolerability of different doses of     JNJ-63871860 (ExPEC4V) in participants greater than or equal to (>=)18 years of age and to     evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked     immunosorbent assay (ELISA).   "
56435|NCT02546947|"     Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective     mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a     prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking     agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could     improve survival remain speculative and the dose of NMBA needed to observe a beneficial     effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion     with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and     an objective of two responses had similar effects on respiratory parameters. In their study,     Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by     a continuous infusion of 37.5mg/h, based on previous results of studies with patients     monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing     neuromuscular blocking drugs, both used in anaesthesia and intensive care units.      The aim of this study was to compare in ARDS patients a dose adjustment of     continuous-atracurium intravenous infusion with an end point of one or two response at     orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of     protective ventilation without monitoring of TOF stimulation.   "
56436|NCT02546934|"     ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)   "
56437|NCT02546921|"     This first in human study of the new therapeutic antibody MOv18 IgE in patients with advanced     cancer seeks to demonstrate the potential for the use of this IgE antibody as an example of     the use of the IgE class of antibodies for the treatment of cancer.   "
56438|NCT02546908|"     The purpose of this study is to document prostate cancer (PC) management including diagnosis,     prognosis, treatment, and care in real-world practice.   "
56439|NCT02546895|"     Head and neck cancers account for the sixth leading cause of cancers worldwide. The annual     incidence of Head and neck cancers is more than 650,000 the patients each year. Head and neck     cancers are associated with smoking, alcohol consumption, human papilloma virus (type 16 and     18) and previous exposure to radiation.      So far, most of clinical and research data about head and neck cancers, such as the etiology,     pathogenesis, prognosis factors and associated factors, treatment outcomes, are from Western     countries. However, due to various environmental factors, for example race, genetics,     geographical factors, general hygiene and health care system differences, the possibility of     differences of disease characteristics between Western and Asian people should be considered.      For several decades, there have been many studies about treatment modalities (surgery,     chemotherapy, and radiation therapy), complications and side effects for head and neck     cancers in the West. Many institutions tried to improve the survival rate and resolve the     toxicity of chemotherapy and radiation treatment for head and neck cancer patients. However     there has been little information about the characteristics of head and neck cancers,     effectiveness of treatment (survival rate, recurrence, and complication rate), and prognosis,     particularly in Korean as well as in Asian patients.      Therefore it is necessary to evaluate and analyze the features of head and neck cancers such     as etiology, pathogenesis, risk factors, prognostic factors, treatment outcomes in a site     specific cohort (South Korea) separately. It could be helpful to improve the treatment     outcomes of head and neck cancers overall, to design race or site specific treatments for     head and neck cancers, and to develop management strategy common in Asia as well as the West.      The purpose of this study is        1. To establish the prospective tumor registry about patient's information,          treatment-related morbidities, treatment outcomes and quality of life, in addition to          the prospective collection of patient samples (blood and tumor tissues).        2. To establish the predictive model for treatment outcomes and treatment-related          morbidities.        3. To develop the biomarkers as predictive and/or prognostic factors.   "
56440|NCT02546882|"     The purpose of this study is to observe whether the transplantation of autologous stromal     vascular fraction (SVF) in adipose tissue is safe and its effect on improving the texture and     contracture of skin grafting.   "
56441|NCT02546869|"     This multi-center, single-arm study is designed to evaluate clinical experience of     participants (or caregivers) administering lebrikizumab at home in participants with asthma.     Eligible participants will receive four doses of subcutaneous (SC) lebrikizumab every 4 weeks     (q4w) up to Week 12. Primary analysis visit occurs at Week 13. After study treatment, all     participants will complete a 12 week safety follow up. All participants will get training for     the administartion of lebrikizumab using the device.   "
56442|NCT02546856|"     Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which     are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme     Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor     Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless,     dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration     of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety.     Objective: To compare doses achieved by patients of BB, ACEI, ARA II and ARM in 4 months ( %     relative to target doses) in the intervention group (HF nurse) and in the control group (     cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart     Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and     mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New     (de novo) HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17     Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and,     driven by protocol, the HF nurse implements the up-titration. In the control group doses are     decided by the cardiologist clinical support and education being provided by nurses.     Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF),     NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP),     6min. walking test, Creatinine/Glomedular Filtration Rate (GFR), Potassium (K), haemoglobin,     Blood Preassure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour     Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality     of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be     provided on the effectiveness of this healthcare management, that could be economically     evaluated in future studies. A qualitative study also will be undertaken to explore barriers     and facilitators to implementation   "
56443|NCT02546843|"     This randomized study prospectively evaluates our experience with administration of     cisatracurium and rocuronium antagonized by sugammadex and evaluates the effects of various     depths of neuromuscular blockage on providing optimal surgical conditions during laparoscopy     with low-pressure capnoperitoneum.   "
56445|NCT02546817|"     To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism     (VTE) patients and patient characteristics that are associated with bleeding among patients     taking Eliquis. To identify factors that might be associated with the safety and     effectiveness profile in Korean VTE patients.   "
56446|NCT02546804|"     Periodontal Disease is a ubiquitous in nature affecting about 80% population of India. The     Periodontal Disease is a multifactorial but the dental plaque is considered as main     etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in     between teeth, if not removed by effective daily brushing and flossing, plaque can cause Gum     infection and tooth loss. Though, many scientific periodontal procedures are available to get     the treatment but because of lack of man power and poor socioeconomic condition it is not     possible for every group of population in our India.   "
56447|NCT02546791|"     This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of     chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include     100 patients treated in different public centers in the Mexican Republic.   "
56448|NCT02546778|"     Nowadays increasingly quest for improved physical appearance, gradually developing the     medicine of beauty, where the radio fits as an additional tool in helping some aging     processes and maintenance of body shape. The aim of this study was to evaluate and compare     the changes in the thickness of adipose tissue and blood levels of some biochemical markers     of sedentary and active women who underwent radio frequency technique via ultrasound imaging     and laboratory tests. Seven (7) sessions were held, each lasting 20 minutes each, 22     volunteers allocated into two groups, sedentary and physically active. Measures ultrasound     image were collected at baseline, pre-treatment and post-treatment period period and serum     biochemical parameters (lipid profile, liver and kidney) for the pre-treatment and     post-treatment.   "
56449|NCT02546765|"     Investigators will assess the incidence and duration of postoperative delirium in patients     ≥60 years old undergoing Coronary Artery Bypass Grafting (CABG), with/without valve surgery     (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia.     Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or     standard postoperative management using IV propofol with morphine or hydromorphine. The     Confusion Assessment Method (CAM) will be used to assess delirium in these patients.     Investigators also seek to compare overall postoperative analgesic requirements in patients     with or without IV acetaminophen. Investigators will finally assess postoperative cognition     in post-surgical patients up to one year post-discharge using a cognitive assessment scale.   "
56450|NCT02546752|"     This primary goal of this study is to assess whether patient whose parents watch a     standardized digital video using the integrated digital approach during a routine office     visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to     those not completing the program. The study team anticipates eligible patients in the     intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses)     than patients in the usual care comparison clinics.      Additionally, the study team is interested in determining the impact of the integrated system     on clinical workflow by measuring the number of minutes of each patient office visit when     using the system compared to the number of minutes of each visit in offices where the system     is not used.      Although this is a descriptive/exploratory aim, our expectation is that the THEO system will     have minimal impact on patient flow.   "
56451|NCT02546739|"     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric     Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed     CD19+ haematological malignancies.   "
56543|NCT02545543|"     This is a study to assess the immune (antibody) response and safety of a Seqirus split     virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US     licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric     population 5 through 17 years of age.   "
56452|NCT02546726|"     This study is intended for inactive, middle-aged adults with untreated pre-hypertension who     live in the Urbana-Champaign area, who are interested in a comprehensive program designed to     enhance physical activity & reduce blood pressure. All participants will be asked to engage     in a program developed in accordance with American Heart Association's recommendations.     Specifically, the program will encourage and support lifestyle behavior changes such as     quitting smoking, eating heart-healthy food, and reducing excessive alcohol, in addition to     weekly exercise. The exercise program will involve a 14-week aerobic training program (3     weekly sessions, scheduled at study participants' convenience), and 2 pre- and 2-post-testing     sessions.   "
56453|NCT02546713|"     The aim of this study is to evaluate the effect of abutment macro-design on soft and hard     tissue responses. This trial is designed as a randomized controlled clinical study in which     two groups of fourteen partially edentulous patients will have as part of their treatment one     implant placed in the maxillary premolar region.   "
56454|NCT02546700|"     Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of     lebrikizumab in participants with COPD and a history of exacerbations who are treated with     inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication.     This study will be conducted to assess the safety, efficacy, and patient-reported outcome     (PRO) measures.   "
56455|NCT02546687|"     Esophageal resection becomes a routine surgical procedure in many medical centers. Usually     reconstruction after esophagectomy is achieved by gastric pull-up with cervical or     intrathoracic anastomosis. The only blood supply for this gastric tube is by right     gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for     future anastomotic leaks or strictures.      The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate)     from the area of future anastomosis before construction of gastric tube and just before     creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with     systemic venous blood.      The investigators suppose that elevation of acid features of blood (pH decreasing, lactate     increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the     significant predictive sign for future anastomotic leaks or strictures.      After operation the investigators plan to find relationship between the blood gas changes and     rate of anastomotic leak and stricture.      This is prospective study. Anticipated cohort of 50 patients   "
56456|NCT02546674|"     The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS <     0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic     phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML')     laboratories adequate and reliable molecular monitoring as a key parameter for assessing     molecular milestones is fostered. Furthermore this trial aims to investigate early prediction     of outcome in newly diagnosed patients with nilotinib by assessing the individual decline of     BCR-ABL transcripts. Quality of life will bemeasured via use of the EORTC CML-24     questionnaire.   "
56457|NCT02546661|"     This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, randomised     Phase 1b study in patients with muscle invasive bladder cancer (urothelial) who have     progressed on prior treatment. This study is modular in design, allowing evaluation of the     safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as     monotherapy and as combinations of different novel anti-cancer agents in patients with muscle     invasive bladder cancer.      The study will consist of a number of study modules (substudies), each evaluating the safety     and tolerability of a specific agent or combination.   "
56458|NCT02546648|"     A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic     acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative     cardiovascular event.   "
56459|NCT02546635|"     Part A: Food effect (a single oral dose of 500 mg AX-024.HCl under fasted and fed states)     Eight (8) healthy male volunteers will receive a single dose of 500 mg AX-024.HCl in the     fasted state (10 h overnight fast), and will return 2 weeks later to receive the same dose of     AX-024.HCl following a meal.      Part B: Multiple doses (a once daily dose of AX-024.HCl or Placebo for 10 days).      Part B is a double-blind, dose escalating, placebo controlled, randomised, multiple dose     study to assess the tolerability, safety and pharmacokinetics in 24 healthy male subjects.     Subjects will be allocated to one of 2 dosing cohorts. Each cohort will have 12 subjects with     9 subjects randomised to receive AX-024.HCl and 3 subjects randomised to receive placebo.      There will be a data review following each dose level. Dose administration in the subsequent     cohorts will only proceed after satisfactory data review on the blinded safety data and     plasma PK data in the previous cohort.   "
56460|NCT02546622|"     This is a longitudinal, observational study of patients with Hemophilia A or B who are     planning to switch to a newly approved coagulation factor replacement product, or who have     recently switched factor products. The study will follow each patient for up to 1 year.     Patients will be recruited at Hemophilia Treatment Centers (HTC) which are ATHN-affiliates.     The primary outcome being studied is the development of inhibitor (i.e., antibodies to     factor) at 1 year or 50 exposure days, whichever comes first.      The study will be conducted at approximately 30 HTCs, with a planned enrollment of 600     patients.The entire study duration is projected to be approximately 6 years.      In addition, optional substudies will be included for some products, as Product-Specific     Modules. These will be questionnaires to collect data for subjects receiving selected Factor     products. For example, subjects receiving Eloctate will be approached to participate in the     'Eloctate Product-Specific Module'; subjects receiving Adynovate will be approached to     participate in the 'Adynovate Product-Specific Module'. Questions will be related to product     use, perceptions of product use, and other post-marketing consumer data.   "
56461|NCT02546609|"     The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in     patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare     two doses of NS-0200 to placebo in NAFLD patients.   "
56544|NCT02545530|"     The majority of chronic hemodialysis patients need a combination of several antihypertensive     drugs for adequate BP control. The primary objective of this study is to evaluate whether     transdermal clonidine can improve blood pressure control or decrease oral antihypertensive     agents type or dosage and the secondary objective is to observe incidence of adverse     reactions of transdermal clonidine in chronic hemodialysis patients.   "
56462|NCT02546596|"     Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of     complete resection and anal sphincter preservation. However, a treatment period of from 5 to     6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is     confronting challenges for maximizing the therapeutic effect and minimizing the side effects.     Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In     this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be     verified during preoperative radiotherapy for locally advanced rectal cancer. The ultimate     goal is to establish a safe and effective treatment protocol.   "
56463|NCT02546583|"     Effective diuresis is the primary goal of most acute decompensated heart failure     hospitalizations, but diuretic resistance is common and our ability to detect it is limited.     Further, there are therapeutically distinct groups of diuretic-resistant patients. These are     not easily distinguished using currently available methods, leading to trial-and-error based     treatment that promotes lengthy hospitalizations.      The aims of this study are:        1. To develop inexpensive and efficient tools to predict diuretic response        2. To understand the prevalence of therapeutically targetable mechanisms of diuretic          resistance using endogenous lithium clearance        3. To develop methodology to differentiate diuretic resistance mechanisms using          common/inexpensive laboratory tests        4. To provide proof of concept that mechanistically tailored diuretic therapy can improve          natriuresis   "
56464|NCT02546570|"     The investigators will use multiple methods (including Oxytocin intranasal inhalation,     neuroimaging, behavioral measures, peripheral hormone measurements) to examine how     individuals' behavior, cognition, and brain function is impacted by the neuro-hormone     Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin     administration on affective processing in non-trauma exposed and trauma-exposed adults (both     with and without posttraumatic stress disorder, PTSD).   "
56465|NCT02546557|"     The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene®     suture concerning its key indication.   "
56482|NCT02546336|"     Hip osteoarthritis (HOA) is a common cause of pain and disability in aging population.     Conservative treatment is based on lifestyle modifications, physical therapy, analgesic and     anti-inflammatory medications and intra articular injections. This Prospective Pilot Study     aims at investigating the efficacy of Ultrasound-Guided Cooled Radiofrequency Hip Denervation     as a treatment offered to patients with HOA.   "
56466|NCT02546544|"     This is an international, multi-centre, single arm Bayesian designed phase 2 study to     identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with     relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7     European centres. Each patient will be treated with single agent linsitinib, 600 mg orally     once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue     toxicity.   "
56467|NCT02546531|"     In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic     strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a     fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated     reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic     effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and     chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK     inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment.     Therefore, these robust preclinical findings will be tested in the proposed phase I trial.   "
56468|NCT02546518|"     Secretory otitis media (SOM) or middle ear effusion is a common finding affecting children in     the age of 4-5 years. It is usually associated with 5-15 deci Bells hearing loss. Although     spontaneous resolution with normalisation of hearing is the usual outcome, this can take     several months. Secretory otitis media is the most common cause of hearing impairment in the     paediatric age group. When the hearing loss caused by SOM is bilateral and persists for 3-6     months or more, surgery with tympanostomy tube insertion under general anaesthesia is     indicated. In Sweden, 10000 children undergo this operation annually. Although many children     with unilateral or bilateral SOM improve in the summer, the problem usually recurs in the     autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish crowns     2005.      In two previous studies, the investigators concluded that the nonsurgical treatment method,     that was developed to assist children with SOM equalising their middle ear pressure, could     normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months.     These children avoided therefore grommet insertion.      The investigators would like to assess the effect of this new treatment method on mainly the     hearing threshold of children with SOM. The investigators expect that using the new method     could help children with SOM avoid operation with grommet insertion.   "
56469|NCT02546505|"     Introducing Front-Of-Pack (FOP) nutrition labelling, providing simplified information on     nutritional content at a glance, in order to help consumer make informed choices, has been     identified as of major interest by public health specialists. In France, a recent report to     the Minister of Health has proposed the introduction of a Front-of-Pack nutrition label, the     5-Colour nutrition label. Existing studies on FOP labels mainly focused on assessment of     consumers' acceptability/liking and understanding. If most of the studies on purchasing     behavior, conducted in real supermarkets, suggested a positive effect of FOP labels on     consumers' food choices, the impact of the 5-CNL has not been evaluated.      The main objective is to evaluate the impact of a Front-of-pack nutrition label, the 5-Colour     Nutrition Label on consumer purchases in a controlled environment close to real-world     settings. Nutritional quality of the items purchased will be compared using the Food     Standards Agency nutrient profiling system (FSA score). The study relies on a comparison     across three independent samples :        -  Control group: The current situation with current way brands show or not nutritional          information on Front of Pack (FoP) - without consumer information        -  Intervention n°1: Introduction of a Front-of-pack nutrition label (5-CNL) on selected          categories of foods. No additional consumer information        -  Intervention n°3: Introduction of a Front-of-pack nutrition label (5-CNL) on selected          categories of foods. Additional consumer information specifically targeting nutritional          information and explaining the 5-CNL will be performed (this information will consist in          a concept shown to respondents before the shopping session).      Participants are recruited in the street through quota sampling, based on criteria of gender,     age and purchasing habits on the products categories selected for the introduction of the FOP     nutrition label.      The study relies on LabStores®, i.e. shopper laboratory stores, which are controlled study     spaces in which a store is recreated in reality.The real lab store mimics a store environment     with real shelves, product, and cash register, and presents several product categories in a     realistic shopping environment. At the end of the shopping session, the respondents proceed     to the cashier but don't actually pay for their purchases.      The selected foodstuffs come from actual retailers' brand products available on the French     market. Three categories of products were selected, based on expected variability in     nutritional quality of the products and logistic criteria (exclusion of fresh products):        -  Breakfast cereals        -  Sweet biscuits        -  Salty snacks The impact of the different labels on nutritional quality (FSA score,          calories, lipids, saturated fatty acids, sugars, proteins, fibre, sodium) of the          shopping cart is investigated using one way ANOVA. Pairwise comparisons among FOP labels          are assessed by using Tukey's multiple comparisons tests.      All tests of significance are two-sided, and a P value <0.05 is considered significant.     Statistical analyses are performed using SAS software (version 9.3; SAS Institute Inc.).   "
56470|NCT02546492|"     This is an open label safety and feasibility trial using Acthar® in addition to the     investigators center-specific standard therapy, which could include increase in maintenance     immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR.   "
78298|NCT02261025|"     The aim of present study is to examine the effect of low-dose aspirin on the incidence of     cardiovascular events and mortality in patients undergoing chronic hemodialysis.   "
56471|NCT02546479|"     Background:      Scoliosis is a curving of the spine. It usually happens in girls when they are children and     teens. Doctors often use x-rays to diagnose it. The x-rays give low radiation. This may     increase the risk that those young women get cancer later in life. Researchers want to learn     more about this risk. They will look data that has already been collected.      Objectives:      To study cancer risks of repeated low radiation from x-rays for scoliosis. Also, to study     death risks related to certain scoliosis patient characteristics. These include causes, kinds     of curvature, and kinds of treatment.      Eligibility:      Medical records of women from past scoliosis studies.      Design:      This U.S. Scoliosis Cohort includes more than 5,000 women who were diagnosed between 1912 and     1965.      Data were collected on these women in the 1980s and 1990s. These came from medical records,     radiology log books, and x-ray films. Researchers found out where participants were,     including if they were dead. Some women were given a follow-up questionnaire.      Researchers want to find out where participants are today. They want to identify new deaths     of participants. They want to find out their causes of death. This data will be added to     other databases.   "
56483|NCT02546323|"     The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to     placebo for treating Chinese patients with subclinical atherosclerosis.   "
56484|NCT02546310|"     To determine if treatment with HTL0009936 will lead to changes in neural activity, measured     using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and     working memory, learning and executive functioning.   "
56485|NCT02546297|"     The purpose of this study is to determine which treatment is more effective and safer for the     patients in COPD C group with bronchiectasis.The research results will help guide physicians     to select appropriate individualized treatment and hopefully provide some evidence-based     medicine proofs for revising guide.   "
56486|NCT02546284|"     This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate     safety, pharmacokinetics, and clinical activity.   "
56472|NCT02546466|"     Background: Low back pain is a major public health problem that affects most people at some     point in life, and results in major psychosocial, economic, functional and physical     consequences that can last for days and months. Most cases are undiagnosed and become chronic     non-specific low back pain. Studies showed that these patients presented changes in postural     control, yet the information is inconsistent, as well as the effects of Functional Taping     (FT).      Objectives: The aim of this study will be to investigate the immediate and one-month     follow-up effects of the use of Functional Taping to lumbar spine on pain intensity and     postural control in patients with chronic nonspecific low back pain (CLBP).      Methods: This study will be a sham-controlled and randomized clinical trial. Participants:     One hundred and twenty participants (18 and 50 years) both genders. Interventions:     Participants will be randomly allocated to receive three possible interventions: Functional     Star-shape Taping, Sham Functional Taping (both interventions during seven days) and a     Minimal Intervention (MI) (one session). Main outcome measures: Primary outcomes will be pain     intensity and posturography to assess balance parameters. Low back pain related disability,     global perceived effect of treatment and fear avoidance beliefs will be considered as     secondary outcomes. Four measurements of static posturography will be conducted:     pre-intervention, immediately after application of the tape, after seven days     post-intervention (after removal of the tape) and after one month follow-up period. Secondary     and primary outcomes will be assessed on three occasions: pre-intervention, seven days     post-intervention and after one month follow-up period. All statistical analysis will be     conducted following the principles of intention to treat, and the effects of treatment will     be calculated using linear mixed models.   "
56473|NCT02546453|"     The search for genetic alterations in primary tumor by NGS techniques followed by the     detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral     samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several     steps and after the treatment could be a tool to monitor the response during and after the     treatment.   "
56474|NCT02546440|"     The main objective of the trial is to investigate whether oral treatment of patients     suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant     improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks of     treatment (primary endpoint). Secondary endpoints will be CTCL severity index, dermatologic     life quality index, itching measured by a VAS and the blood involvement if applicable.      Primary: safety and efficacy of DMF treatment in CTCL Secondary: CTCL severity index,     Dermatologic Life Quality index, VAS for itching, blood involvement if appl.   "
56475|NCT02546427|"     This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole     pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate     cancer as defined by NCCN risk criteria. Patients will have >15% risk of lymph node     involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study     will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy.     Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH     agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months     for the first 24 months after completion of radiotherapy in a similar schedule to usual     standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be     collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented.     An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the     first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated     if >30% acute grade 2 or >5% grade 3 or greater toxicity is observed as a result of radiation     treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or     noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant     but not immediately life-threatening event requiring hospitalization or prolongation of     hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of     Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated     radiotherapy followed by brachytherapy.   "
56476|NCT02546414|"     To validate the PC/SD ratio to be used to predict the variceal haemorrhage in Chinese     patients with hepatitis B virus (HBV)-associated hepatic cirrhosis.   "
56477|NCT02546401|"     The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin     and commonly used in the treatment of type 1 diabetes, where it obtained the marketing     authorization for this indication. In the patient who have an insulin pump, insulin Aspart is     given daily like a pre-prandial bolus (just before the meal). However, many patients perform     their bolus after the meal. However this insulin administration modality is not clearly     studied in the literature.   "
56478|NCT02546388|"     The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can     help doctors diagnose people with cardiac sarcoidosis better.      OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to     diagnose certain tumors.   "
56479|NCT02546375|"     The purpose of this study is to describe the efficacy and safety of bosutinib in patients     with chronic myeloid leukaemia used in a real world setting   "
56480|NCT02546362|"     The objective of this pilot open trial is to investigate the efficacy and safety of e-TNS     with the Cefaly(R) device in fibromyalgia.   "
56545|NCT02545517|"     The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to     assess the boostability of immune responses in subjects who received a primary series of     accelerated or conventional rabies PrEP IM regimen.   "
56546|NCT02545504|"     The primary objective of this study is to compare the efficacy of andecaliximab (formerly     GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV),     and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.   "
56481|NCT02546349|"     It is recognized that eosinophilic airway inflammation is more likely respond to steroid     treatment. However, in real-world practice, it is difficult to routinely assess airway     inflammation using sputum induction because of technical and facility requirement. COPD     (chronic obstructive pulmonary disease) is a heterogeneous disease and it remains a great     challenge to identify patients who have eosinophilic airway inflammation and respond to     steroid treatment well. A recent study demonstrated elevated plasma D-dimer was associated     with acute inflammation and a significant predictor of pulmonary embolism in COPD exacerbated     patients. D-dimer may potentially act as a marker of inflammation and a predictor of     cardiovascular event in COPD patients. The investigators preliminary study demonstrated that     exhaled nitric oxide (eNO) > 23.5 ppb is a good surrogate marker to predict eosinophilic     airway inflammation in COPD patients who were newly diagnosed or untreated for at least 3     months. There were significant correlations among sputum eosinophils, eNO and serum total     immunoglobulin E (IgE). Particularly, eNO predicted sputum eosinophilia (> 3%) in COPD at a     sensitivity and specificity of 62% and 71% respectively. Herein, the investigators test the     hypothesis that eNO may act as a biomarker to determine treatment option for COPD.   "
56487|NCT02546271|"     Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive     gay and bisexual men, which takes place in a group counselling format. All participants     provided written informed consent at the outset of the study. Eligible participants filled     out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants     attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay     men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS     program, participants were scheduled to attend a 1-hour session to complete the same     questionnaire package. Participants received an honorarium and a list of community resources,     including mental health or substance use counseling services, at the end of each assessment.     Participants also participated in a program evaluation interview at the 3-month follow-up     assessment.   "
56488|NCT02546258|"     This is a prospective, open label, non-comparative clinical investigation to evaluate the     performance of a Fungal Nail Treatment on the visual signs of onychomycosis.      The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available     as an over-the-counter product.      The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail     infections will be determined by a reduction in the surface area of the infection over time.     This will be assessed through visual quantification of the infected area from baseline, as     measured by image analysis, throughout the treatment period, where subjects will follow     instructions for use on the product pack and self-treat for the duration of the investigation     or until their condition has resolved. Both subject and podiatrist will assess the     improvement of signs and symptoms of the target nail.   "
56489|NCT02546245|"     The goal of the proposed research is to adapt and rigorously evaluate educational mobile     games, designed as a downloadable mobile apps to be played on smartphones or tablets.     Investigators will be partnering with Yogome for this project. Yogame is a company dedicated     to creating educational games that aim to reinforce knowledge acquired in school and help     children learn new things in an entertaining and fun way.   "
56490|NCT02546232|"     The purpose of the study is to investigate the molecular biology of the tumor in relation to     treatment response to chemotherapy, in particular paclitaxel compared to the combination     paclitaxel and carboplatin. The study is carried out in two different, separate cohorts:      Cohort I: Patients with large primary breast cancer (> 2.0 cm) including locally advanced     disease, are treated with weekly paclitaxel for 12 weeks, before continuing on anthracycline     containing regimen for another 12 weeks before surgery. Patient are randomized 1:1 to receive     carboplatin in addition to paclitaxel for the first 12 weeks of the treatment.      Cohort II: Patients with metastatic disease, available for biopsies before and during therapy     are included to receive paclitaxel for 24 weeks. Patients are randomized 1:1 to receive     paclitaxel alone or paclitaxel in combination with carboplatin.   "
56491|NCT02546219|"     The overall objective of this preclinical study is to further the investigators mechanistic     understanding of the role that the α4β7 and mucosal addressin cell adhesion molecule     (MAdCAM-1) pathway plays in mediating eosinophil recruitment in EoE. To accomplish this, the     investigators aim to (1) determine the baseline and dynamic patterns of α4β7 integrin     expression on circulating and tissue eosinophils in EoE and in the setting of non-EoE     esophageal eosinophilia (e.g., reflux esophagitis) and (2) determine the complete profile of     eosinophil integrin molecules that may play a role in active EoE.   "
56560|NCT02545322|"     Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy     concept. This involves the adaption of the radiotherapy treatment plan according to changes     in tissues and variations in patients position and posture during a radiotherapy treatment     course, based on repeat CT scans.      It is investigated, if dosimetric improvements can be achieved using this approach and if the     method using the software-package ReDeform can be implemented in clinical Routine.   "
56492|NCT02546206|"     The aim of this study was to evaluate the effects of probiotic yoghurt on the development of     gingival inflammation.      Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and     randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt     containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural     yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted     for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data     (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected     at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.   "
56493|NCT02546193|"     Induction of labor, or causing labor to start before it otherwise starts spontaneously, is     sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant.     Labor induction often begins with cervical ripening, in which various methods are used to     prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases     the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant     women are admitted to the hospital at the start of this process and remain inpatient until     after the baby is born.      There is increasing interest in allowing the mother to return to her own home during the very     first part of this process. She may be more satisfied in a more comfortable environment with     her family. Growing scientific evidence supports use of the Foley catheter as an approach to     outpatient cervical ripening. The Foley catheter is a safe, effective method that is already     used often in the inpatient setting. It does not cause increased health risks for either     mother or baby. Previous research studies have shown that it is just as safe and effective     when women return to their own homes with a Foley catheter and that women spend less time in     the hospital before delivery. More information is needed before this becomes a standard of     care. This research study will allow pregnant women to return home for the first night of     their labor induction with a Foley catheter in place. In the morning they will return to the     hospital and stay until after delivery. They will be compared to a group of women who remain     in the hospital for their entire labor induction. The benefits to going home during labor     induction may include increasing maternal satisfaction and optimizing the use of resources in     the hospital.   "
56530|NCT02545712|"     The purpose of this study is to explore the quantity of excipient exposure in neonatal and     young pediatric patients in a Danish Hospital. The focus will be on the preservatives     ethanol, propyl glycol, benzyl alcohol, methyl-p-hydroxybenzoate and     propanyl-p-hydroxybenzoate and the artificial sweeteners acesulfam potassium, aspartame,     glycerol and sorbitol.   "
56494|NCT02546180|"     This prospective randomized pilot clinical trial studied the effect on preoperative anxiety     of watching a series of YouTube videos designed to create a virtual hospital experience for     patients undergoing primary total hip and knee arthroplasty as compared to routine     preoperative education.      Hypothesis: Preoperative anxiety related to hip and knee replacement surgeries can be reduced     by patient exposure to a virtual hospital inpatient experience delivered by a series of     YouTube videos.   "
56495|NCT02546167|"     Open-label, single-center, pilot study to assess the safety and feasibility of infusion of     autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen     receptors with tandem TCR and 4-1BB costimulatory domains (referred to as CART-BCMA ) in     adult patients with multiple myeloma (MM). CART-BCMA cells will be given as a split dose     intravenous infusion over 3 days. The duration of active intervention and monitoring is     approximately 2 years.   "
56496|NCT02546154|"     The objective is to monitor and quality assure the efficacy, including effects on quality of     life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease patient     populations when Monofer® is used according to the Monofer® label (Summary of Product     Characteristics, SPC) in current clinical practice and where standard routines are being     followed.   "
56497|NCT02546141|"     This study was designed to obtain information about the change in postprandial amino acids in     blood over time, after consumption of different dairy products, in an elderly population and     how this relates to gastric emptying rate and feelings of satiety.   "
56498|NCT02546128|"     To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured     home-exercise programme has any additional benefit to patients with tendinopathies   "
56499|NCT02546115|"     To assess whether the provision of a tension night splint (TNS) device has any additional     benefit in patients with chronic plantar fasciitis, compared to routine care comprising     physiotherapy & podiatry alone.   "
56500|NCT02546102|"     ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are     pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA)     present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients     with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care     chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with     the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target     glioblastoma tumour cells.   "
56501|NCT02546089|"     To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI),     which includes a dry-needling component within the overall procedure, has any measureable     clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar     fasciitis.   "
56502|NCT02546076|"     Skin injuries due to trauma are relatively common, and patients are very concerned about     scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative     lasers based on the fractional approach has become a novel strategy for the treatment of     scars.      The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering     pulses either with and without heat/coagulation in a cohort of patients with long     keloid/hypertrophic scars.      The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent     to laser with heat/coagulation in terms of scars volume reduction, while the secondary     hypothesis is that ablative fractional laser without heat/coagulation is superior in terms of     post-operative erythema and hypopigmentation reduction.   "
56561|NCT02545309|"     SSC-CIP is increasing in patients after critical illness. Pathogenesis is still largely     unclear. The investigators hypothesize that genetic variants of biliary transporter genes are     frequent in patients with SSC-CIP. In approximately 140 patients and controls the rate of     genetic variants in biliary transporter genes, gut permeability and gut microbiome as well as     bone health will be studied.   "
56503|NCT02546063|"     The standard method for determining the carbohydrate content of a meal in patients with     diabetes mellitus is the weighing of individual foods. However, in daily life, the weighing     is not practical at all times. Inaccurate estimation of meal's CHO content, leads to wrong     insulin doses and consequently to poor postprandial glucose control. Fact is that even well     trained diabetic individuals find it difficult to estimate CHO precisely and that especially     meals served on a plate are prone to false estimations underlining an emergent need for novel     approaches to CHO estimation.      GoCarb is a computer vision-based system for calculating the carbohydrate content of meals.     In a typical scenario, the user places a credit card-sized reference object next to the meal     and acquires two images using his/her smartphone. A series of computer vision modules     follows: the plate is detected and the different food items on the plate are automatically     segmented and recognized, while their 3D shape is reconstructed. On the basis of the shape,     the segmentation results and the reference card, the volume of each item is then estimated.     The CHO content is calculated by combining the food types with its volumes, and by using the     USDA nutritional database. Finally, the results are displayed to the user.      A preclinical study using the GoCarb system indicates that the system is able to estimate the     meal's CHO content with higher accuracy than individuals with T1D. Furthermore, the feedback     gathered by the participants showed that the system is easy to use even for non-smartphone     users.      The aim of this randomized, cross-over pilot study is to investigate the benefits of an     automated determination of the carbohydrate content of meals on glycemic control in subjects     with type 1 diabetes mellitus with sensor-augmented insulin pump therapy.   "
56504|NCT02546050|"     OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes     in metabolic markers in urine, saliva, blood and fecal samples following metformin treatment.      DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week     pre-intervention period, 6-week intervention period and a 6-week post-intervention period. 25     healthy young men will be included in the trial.      INTERVENTION: Six-week Metformin treatment to young healthy men.   "
56505|NCT02546037|"     Primary Objective:      The purpose of this study is to measure the amount of convection achieved with two different     haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration     treatment.   "
56531|NCT02545699|"     The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™     colonoscopy with that of standard colonoscopy.   "
56506|NCT02546024|"     Depression is a common disorder, especially in old age, where it is associated with     significant morbidity and mortality.      This study will investigate whether there are features of individual patients with major     depression that may predict positive treatment response. The study will invite 40 patients     who have been diagnosed with major depressive disorder with onset after the age of 60 years     to participate. Participants will be recruited from the Mental Health of Older Adults     services at the South London and Maudsley NHS Mental Health Foundation Trust. Participants     will receive usual treatment as set out in standard Care Pathways, used by the clinical care     team. As part of the study, they will undergo a short battery of neuropsychological tests and     a standard MRI brain imaging protocol. The neuropsychological tests and assessment of     depression severity will be carried out twice (at Baseline and Week 12). Data will be     analysed to investigate whether there are features specific to those patients who show a good     response to antidepressant treatment after 12 weeks. Identification of such predictors may     help to stratify treatment approaches in the future and lead to the early identification of     individual patients who may require alternative treatment approaches to standard     antidepressants.   "
56507|NCT02546011|"     The goal of this study is to compare the amount of time that the fetal heart tones are traced     in babies just at or beyond viability using a traditional device compared to the Monica     device.   "
56508|NCT02545998|"     The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies     in both primary and secondary care resulting in one of the highest mortality rates in Europe.     A key recommendation in the report is the provision of an annual asthma review in primary     care.      Telehealthcare is an alternative means of service delivery incorporating the use of telephone     and e-mail consultations which may improve access and quality of patient care. There is scant     data on the role of teleheathcare in asthma care.      This is a single-centre, primary care-based, randomized controlled trial to evaluate the use     of telehealthcare to conduct the annual asthma review for adult patients with well-controlled     asthma. This will be compared with standard care (face-to-face consultations).      Telehealthcare will consist of a telephone consultation followed by an e-mail with an     attached personalised asthma action plan and a link to a video demonstrating inhaler     technique.      Standard care will involve a face-to-face consultation in primary care. The two patient     groups will be compared prospectively to determine whether there is a difference in the     quality of care evaluated in terms of the patient experience/ satisfaction, health-related     quality of life, asthma control and frequency of asthma exacerbations over a 6 month period     after the asthma review.      The data will be presented in the form of frequency tables, bar charts and pie charts.     Non-parametric tests will be applied to determine whether there is a significant difference     in the quality of care received.   "
56509|NCT02545985|"     The aim of this study was to assess the safety and the efficacy of the novel     sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.   "
56510|NCT02545972|"     This study investigates the use of tacrolimus extended release in stable patients who have     undergone a heart transplant. All patients will receive the study medication free of charge     for the 1 year duration of the study.   "
56511|NCT02545959|"     The goal of investigators is to study the kinetics of action of a single dose of     intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets in     progressive MS patients. Various markers of central nervous system inflammation (osteopontin,     Tumor Necrosis Factor α, IgG secretion) and neurodegeneration (neurofilament) are studied at     multiple time-points, assuming that a definitive action upon CSF biological targets would be     strongly predictive of a delayed clinical action.   "
56512|NCT02545946|"     Comparing the outcome of traditional incision and drainage with a larger skin incision with     or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive     incision and drainage with two small incisions and a vessel loop transversing the incisions     to keep them open.   "
61025|NCT02486796|"     This study is examine the effect of the addition of naturopathic on immunologic and/or     inflammatory parameters and/or quality of life in women receiving neoadjuvant chemotherapy     for breast cancer.   "
56513|NCT02545933|"     Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the     standard of care for the long-term secondary prevention of atherothrombotic events in     patients with myocardial infarction (MI). However, rates of ischemic recurrences remain high,     which may be in part due to the fact that other platelet signaling pathways, such as     thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a     protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of     thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug     Administration for the reduction of thrombotic cardiovascular events in patients with a     history of MI or with peripheral arterial disease. However, to date clinical trial experience     with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor clopidogrel and     the effects of vorapaxar in combination with antiplatelet therapy including prasugrel or     ticagrelor, is largely unexplored. Further, the role of vorapaxar as part of a dual     antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with     withdrawal of aspirin, represents another important area of clinical interest as it has the     potential to maximize ischemic protection while reducing the risk of bleeding. The proposed     prospective, randomized, parallel-design, open label, study conducted in a real world     clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of     vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor     (prasugrel or ticagrelor) with and without aspirin.   "
56514|NCT02545920|"     This is a prospective observational pilot study of patients under the care of the Royal Free     Hospital with chronic kidney disease who have been established on regular thrice weekly     haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear     during haemodialysis.   "
56515|NCT02545907|"     This study evaluates the safety and efficacy of carfilzomib used in combination with     thalidomide and dexamethasone in patients with relapsed AL amyloidosis. The trial begins with     a dose escalation phase, in which the maximum tolerated and recommended dose will be     determined. The trial will then open into an expansion phase in which the combination     efficacy is assessed.   "
56532|NCT02545686|"     CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing     and chest wall motion.   "
56516|NCT02545894|"     People with global aphasia (PwGA) post stroke have little to no meaningful communication     abilities (ie limited comprehension, spoken language, reading and writing abilities).A     proportion of PwGA will also have limited abilities to use any alternative means of     communication e.g. gesture, pictures or computer devices. There is a suggestion in the     literature that this is because of co-occurring cognitive deficits. The consequence is that     these clients are unable to reliably communicate even their basic needs.This is commonly     known as having no functional communication abilities. Such PwGA tend not to respond to     standard speech and language therapy interventions.      This research will investigate the effect of a new cognitive intervention designed to improve     basic functional communication abilities. The treatment will be nonverbal and involve     computer and paperbased tasks ordered hierarchically from basic to more complex tasks. Six to     eight participants will take part. All their sessions will take place in their own home. For     some this may be a care home. They will first complete a diagnostic communication assessment     in order for baseline abilities to be established. Further formal language and cognitive     assessments will be conducted over a period of 6 weeks. A relative/friend will complete a     questionnaires about mood/communication. The PwGA will also be videoed interacting with the     research student e.g. looking at a magazine, completing a jigsaw, answering questions and     making choices non-verbally.      The participants then receive the new intervention 3 times a week for 6 consecutive weeks.     All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks     using the same assessments as prior to the intervention. The questionnaire with their     relative/friend and videoed activity session will also be repeated. After a twelve week break     the participant will be videoed interacting with the research student complete some of the     assessments again and their relative will re-complete the questionnaires.   "
56517|NCT02545881|"     The purpose of this study is to develop, validate, and evaluate the correlation of novel     magnetic resonance imaging (MRI) methods with prostate cancer aggressiveness and histological     data obtained during prostatectomy.   "
56518|NCT02545868|"     This multicenter, randomized, open-label study will evaluate the immune response to vaccines     (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide     vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine     [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose     of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).   "
56519|NCT02545855|"     This is a prospective, randomized crossover study for evaluation of the efficacy and safety     of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD     patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)     and hypercapnia who require home oxygen therapy (HOT). The total duration of subject     participation will be 52 weeks, consisting of 12-week treatment period and 40-week     continuation period. Subjects who satisfy all inclusion and exclusion criteria will be     randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus     HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus     HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®,     in addition to their current HOT. After treatment period, the willing subjects can continue     the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end     of the study is defined as the treatment period or continuation period end date of the last     participant, whichever is later. Subjects will primarily be assessed by the St. George's     Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.   "
56521|NCT02545829|"     The purpose of this study is to investigate the bioequivalence after administration of     HIP1302 and HGP1406 in healthy male volunteers.   "
56585|NCT02544997|"     Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective     therapeutic strategies including targeted agents.      Poziotinib is a panHER tyrosin kinase inhibitor (TKI) that showed stable activity with     feasible toxicity for MBC patients as a salvage treatment strategy after failure of     anthracycline and taxane in phase I trial. Poziotinib has rational benefit compared with     other salvage agents, especially for patients with HER2 overexpression breast cancers.     Additionally, a recent report showed that possible rational background for patients with HER2     mutation-positive breast cancers.      Based on this rationale, the investigators are to conduct phase II single-arm study of     poziotinib for patients with MBC who showed refractoriness to conventional treatments as     salvage treatment.   "
56522|NCT02545816|"     After any acute brain injury, a primary pathophysiological response arises, enabling the     brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in     patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain     injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without     any clinical motor signs, which are then termed as nonconvulsive, and therefore remain     frequently clinically unrecognized. As such, it is of great importance that these patients     are diagnosed as early as possible since the increased metabolic demand and blood flow     associated with an epileptic insult may further compromise the brain at risk. Thus far,     continuous EEG (cEEG) is the only clinical instrument that is able to detect the development     of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is     labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore,     a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an     early stage so that patients might benefit from a specific and early treatment. A validation     study in comatose patients with an acute neurological insult will be conducted to provide     evidence that simplified Bispectral Index EEG monitoring has the potential to detect     epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG     monitoring could possibly be used to facilitate the prognostication and management of     epileptic seizures in this patient cohort which could eventually improve the clinical     outcome.   "
56533|NCT02545673|"     The purpose of this study is to evaluate the effectiveness of a linkage to care intervention     at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to     /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among     people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural     Uganda.   "
56566|NCT02545244|"     The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on     teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash     to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical     trial among adults of 18-40 years of age.   "
56567|NCT02545231|"     To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal     hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and     near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse     cardiovascular events during 3-year follow-up.   "
56581|NCT02545049|"     The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to     standard daily therapy, is effective and safe in treating patients with type 2 diabetes     mellitus and diabetic kidney disease, when compared to a placebo.   "
56523|NCT02545803|"     Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may     result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma     and postoperative complications. In an attempt to preserve or increase the oxygenation,     conventional mechanical ventilation is initiated in these patients. Unfortunately, patients     frequently become refractory to standard ventilatory techniques and as such, gas exchange     remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the     other hand, is an advanced mode of ventilation which can be a salvage option in these patient     cohorts as it has already been proven to improve gas exchange with success. The volumetric     diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only commercially     available system to deliver HFPV. This ventilator mechanically ventilates the lung by     administering small successive subtidal volumes or percussions at unconventional high     frequencies to reach an optimal diffusive oxygenation.      Since it has been known that hypoxemia due to a reduced oxygenation results in secondary     brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as     well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range     has an ameliorative influence on hypoxic events and in turn leads to a better clinical     outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation     by means of a switch to HFPV automatically leads to an increment in the cerebral tissue     oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators will     investigate whether this alternation of ventilation strategy is associated with a     (beneficial) change of the cerebral tissue oxygenation.   "
56524|NCT02545790|"     This study is designed to learn more about children who have blockage of the left side of     their heart. The goal is to determine how much the heart muscle has thickened before surgery     and how it changes in the months after surgery. Investigators are also looking for blood     tests that may help them predict which patients will have the most thickening pre-operatively     and the best return towards normal after surgery. The findings of this study will help the     investigators develop new tests to monitor affected patients and develop new therapies to     help minimize heart thickening.   "
56525|NCT02545777|"     This research is based on spleen trapped by dampness and turbid which is the pathogenesis of     gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In     this study, the investigators use multi-center randomized parallel controlled clinical     trials.The treatment groups are afforded oral traditional Chinese medicine     decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet     wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a     positive control drug.The outcome is evaluated by condition of symptoms remission,pain relief     time, recurrence rate and laboratory index to determine the efficacy of internal and external     treatment.And the research will provide optimized diagnosis and treatment program. The     investigators hope this research will also get tonifying spleen and descending the turbid     internal and external treatment for gouty arthritis effective clinical treatment.   "
56526|NCT02545764|"     Childhood obesity is one of the most critical and accelerating health challenges throughout     the world. It is a major risk factor for developing varus/valgus misalignments of the knee     joint. The combination of misalignment at the knee and excess body mass may result in     increased joint stress and damage to articular cartilage. A training programme, which aims at     developing a more neutral alignment of the trunk and lower limbs during movement tasks may be     able to reduce knee loading during locomotion. Despite the large number of guidelines for     muscle strength training and neuromuscular exercises that exists, most are not specifically     designed to target the obese children and adolescent demographic.      The purpose of this study is to evaluate a training programme which combines strength and     neuromuscular exercises specifically designed to the needs and limitations of obese children     and adolescents and analyse the effects of the training programme from a biomechanical and     clinical point of view.   "
56527|NCT02545751|"     Patients with esophageal cancer that had metastatic lesions after been treated with     definitive surgery or chemoradiotherapy are being asked to participate in this study.        1. To observe immunity-mediated tumor response after Stereotactic Body Radiation          Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.        2. To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and          thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study          will help find out what effects (good or bad) the combination of radiotherapy and          thymalfasin has on metastatic esophageal cancer.   "
56528|NCT02545738|"     The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2     diabetes.   "
56586|NCT02544984|"     The purpose of this study is to determine if the prophylactic use of azithromycin will reduce     the total number of days when unscheduled treatment is given outside of the home in a clinic,     urgent care, emergency room or hospital setting between the respiratory illness season months     (October 1-March 31) and subsequent 2 month follow-up (April and May)   "
61026|NCT02486783|"     Suriname is a small developing country in South America with a population of half a million     people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished     data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of     infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In     comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These     numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In any     case about 40 newborns that die each year of infection are a huge loss, also considering the     small Surinamese community. Despite this overall idea on the impact of infectious disease in     Surinamese neonates exact information regarding incidence, type of infection (e.g.,     localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient     antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes,     morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g.,     gestational age, sex, ethnicity) are lacking.      From a clinical perspective, there is still a challenge to identify neonates with infection.     Neonates are often admitted with ambivalent clinical symptoms and receive preventive     antibiotics that are costly, promote pathogen-resistance, and have negative long-term effects     (i.e., on the development of the intestinal bacterial flora). Currently, assessment of blood     leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be used as     biomarkers, while confirmation of actual sepsis or meningitis by positive culture results is     relatively rare (0.5-3% in the United States). This complicates decisions on duration of     antibiotic treatment and hospitalization significantly, while no other biomarkers exist.      The circulating isoforms of adhesion molecules (cAMs), which mediate interactions of     leukocytes with the vascular endothelium, have been proposed as biomarkers for infection and     sepsis. During infection they accumulate in the bloodstream as a result of shedding, which     represents their removal from cell surfaces of endothelial cells and leukocytes by enzymes     called sheddases. Recently, we have reviewed mechanisms behind shedding of cAMs in neonatal,     pediatric and adult sepsis. The shedding process reflects a critical and active process in     orchestrating interaction between leukocytes and the endothelium for an effective host     response, while minimizing collateral tissue damage. As a result, both plasma levels of cAMs     and their sheddases are subject to change during infection and sepsis. Additionally,     compelling, albeit limited, data suggest changes of levels of cAMs in CSF in adult and     pediatric meningitis.      To date, some evidence exists of changes in levels of cAMs during malaria (in children from     Malawi) and sepsis, although not sensitive enough to predict outcomes in the clinic. Those     levels have never been assessed simultaneously with levels of their sheddases in blood or CSF     as a diagnostic tool. We propose that this combined approach may provide more detailed     information about the extent of inflammatory activation in neonates.While a balance in levels     is maintained under resting conditions or mild (local) infection, it may be perturbed during     sepsis or meningitis . Thus, simultaneous measurement of these levels could promote early     identification of infection, and may even distinguish between mild infection, systemic     infection or meningitis. Currently, manufacturers are rapidly developing Luminex® technology     as an advanced, fast, high-throughput and clinically feasible bedside tool for such an     approach.      We hypothesize that incidence rates of neonates with infection in Suriname are high. We     further hypothesize that, upon signs of infection, the simultaneous measurement of cAMs and     their SEs in serum and CSF discriminates between infected and non-infected neonates. We aim     to: 1) identify and follow neonates at the Academic Hospital Paramaribo with signs of     infection to establish incidence rates of infection, and 2) investigate diagnostic potential     of our proposed biomarker combination in these neonates for infection, type of infection     (e.g., local (mild), sepsis or meningitis) and outcomes.   "
56529|NCT02545725|"     This study is collecting data on quality of life, (care)needs and socio-economic factors in     colorectal (ex-)cancer patients via a written questionnaire completed by the patient     him/herself. The collected data will be linked with the patient- and tumour characteristics     available in the database of the Belgian Cancer Registry and with the facturation data     supplying information about diagnostic techniques and performed treatments (available via the     insurance companies).      Based on the selection criteria, 1220 patients were finally selected from the database of the     Belgian Cancer Registry. These patients received an invitation letter by regular mail, a     detailed questionnaire and an informed consent.      The questionnaire contains topics as sociodemographic, life style, comorbidity, satisfaction     with the provided information, care needs, quality of life, anxiety and depression, financial     situation etc.      The patients were asked to complete the questionnaire and send it back, together with the     signed informed consent, to the study-collaborators.      After 2-4 weeks, a reminder was sent. At that time, a reply card was added. If a patient     doesn't want to participate in this study, a reason can be mentioned on the reply card.      The collected data are linked with the clinical data. The dataset will be coded before     analyses will start.   "
56551|NCT02545439|"     This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics     of ALKS 5461.   "
56534|NCT02545660|"     During orthodontic treatment bacterial plaque readily accumulates on the teeth. This is     because food easily accumulates around the braces and it is more difficult to clean when the     braces are in place. The plaque accumulation can lead to demineralisation (white spots)     developing on the teeth. This is the start of decay and can lead to permanent marks and     fillings being required.Prior to the start of orthodontic treatment adequate oral hygiene is     necessary.      During orthodontic treatment, it is important that patients have an excellent level of oral     hygiene to prevent plaque accumulating and demineralisation occurring. However, adequate     tooth brushing can be difficult to perform as the bacterial plaque is not easily visible.     Thus patients may not be able to see which areas need better tooth brushing.      QLFD(Quantitative Light Induced Fluorescence Digital) is a noninvasive method that uses     fluorescent light to illuminate the oral bacteria in plaque that are responsible for     demineralisation. The purpose of this study is to use the QLFD camera to assess its ability     to measure plaque accumulation and demineralisation before the start of orthodontic     treatment. The study will also assess the QLFD camera as a tool to improve oral hygiene.   "
56535|NCT02545647|"     A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient     because weight regain can occur. An intervention to prevent weight regain in the future is to     place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB)     which increases weight loss and decreases weight regain on the longer term. The question is     whether primary application of a banded bypass gives a greater weight loss and / or prevent     weight regain in the future versus a standard RYGB.   "
56536|NCT02545634|"     The study will examine the effect of a probiotic supplement (Lactobacillus helveticus R0052     and Bifidobacterium Longum R0175) dissolved in a dairy product such as milk or ice-cream on     symptoms of ADHD and anxiety in children. The main goal is to determine if probiotics might     be useful as a treatment for anxiety and ADHD symptoms in children. A second goal is to     examine the effects of probiotics on saliva cortisol levels. Finally, the investigators are     also interested in the effects of the probiotics on children's digestive health.   "
56537|NCT02545621|"     RAGE (the receptor for advanced glycation end-products) is a marker of alveolar type I cell     injury and a pivotal mediator of acute inflammation and innate immunity. RAGE pathway is     highly regulated; the interaction of the transmembrane receptor with its various ligands     (e.g. HMGB1, S100A12) ultimately leads to NF-kB activation and RAGE upregulation itself, but     precise RAGE functions and intracellular pathways remain underexplored. During ARDS, monocyte     and macrophage activation could modulate alveolar inflammation and repair.      As RAGE is also expressed at the surface of monocytes/macrophages, we hypothesize that     alveolar monocyte/macrophage activation may be mediated through a RAGE-TXNIP (thioredoxin     interacting protein)-NLRP3/inflammasome intracellular pathway. The purpose of this     observational prospective study is to compare alveolar monocyte/macrophage activation     profiles (as assessed by Fluorescence-Activated Cell Sorting (FACS)) in mechanically     ventilated patients with or without ARDS.   "
56538|NCT02545608|"     The purpose of this study is to determine the safety and efficacy of using Restylane Vital     for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will     be done by a blinded evaluator.   "
56539|NCT02545595|"     This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40     kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is     performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the     end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2     mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is     defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if     recurarization occurs within 15 min after complete reversal success.   "
56540|NCT02545582|"     This registry will observe patients with symptomatic heart failure with implantable vagus     nerve stimulation to provide insights into safety and efficacy during clinical routine.   "
56541|NCT02545569|"     The purpose of this evaluation is to receive the greatest benefit of new custom made hearing     product technology and shell modification for the end customer and to continual improve the     custom made hearing products.   "
56547|NCT02545491|"     Background: Responsive stimulation and/or enhanced nutrition interventions delivered to     children through health programs shows improved cognitive, language, and motor, and the     social-emotional status. This could benefit young children in Lebanon and worldwide to     improve their developmental potential.      Aim: This study aims to implement Care for Child Development (CCD) intervention for children     aged 0-3 years within a supportive environment in Day Care Centers and to investigate its     effectiveness on early child development.      Methodology: CCD program will be implemented in 10 randomly selected daycare centers in     Lebanon where three providers in each center will be trained (CCD-group). Another group of 10     day care centers will serve as controls (WV-group). 228 Children in each group will receive     either early stimulation based on CCD and education from the World Vision Infant and Young     Child Feeding (WV-IYCF) project (CCD-group) or education from the WV-IYCF project (WV-group).     Caregivers' knowledge and behaviors will be assessed before and after the intervention using     a predetermined questionnaire and behavioral checklist. Early child development will be     assessed using Ages and Stages Questionnaire-3 (ASQ-3) and Bayley Scale for infant     Development (BSID-III).      Expected Outcome: Implementation of CCD program in day care centers will be feasible and will     lead to enhanced early child development. This study will serve as a prototype for program     implementation throughout the country and the region.   "
56548|NCT02545478|"     The purpose of this investigation is to evaluate how early biomarkers of infection and     inflammation perform in identifying patients at risk for poor outcome in sepsis and septic     shock.   "
56549|NCT02545465|"     The aim of this study is to understand the treatment patterns in patients with Pulmonary     Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a     switch of treatment to Adempas in real-life clinical practice.      In addition, this study will describe patient demographics and reason for switching   "
56550|NCT02545452|"     To investigate the pharmacokinetic effect of a vaginally administered antimycotic     (miconazole), antibiotic (clindamycin), spermicide (nonoxynol-9) or the concomitant use of     tampons during the use of an intravaginal ring releasing anastrozole and levonorgestrel   "
56552|NCT02545426|"     Chronic kidney disease (CKD) is linked to elevated mortality rate, and cardiovascular disease     is the main cause related to this outcome. The cardiovascular mortality among patients on     conventional hemodialysis (CHD) is high, achieving up to 30 times more risk of death when     comparing to individuals of same age on general population. Congestive heart failure can     develop in 25% to 50% of patients, leading to a worse prognosis. CKD patients present     anatomic and functional abnormalities on peripheral bed vases and also cardiovascular     abnormalities that can cause myocardial ischemia. This last usually is transitory and lead to     left ventricular dysfunction that can persist even after the end of dialysis session despite     normal coronary perfusion. The prolonged dysfunction is called myocardial stunning (MS).     Patients on CHD are subject to hemodynamic instability, myocardial ischemia and development     of regional abnormalities of myocardial wall (ARPM´s). MS induced by intradialytic ischemia     is a complication that can be minimized by applying techniques associated to more stability     during the CHD, as cool dialysate or increasing the length of the therapy. The goal of the     present study is to evaluate the behavior of cardiovascular system (trough hemodynamic     performance during CHD, accessing MS by echocardiography technique, and biomarkers associated     to MS). Finally, the investigators aimed to investigate the role of two different dialysate     calcium concentration (2,5 and 3,5 mEq/l) in the genesis of MS during CHD. The elucidation of     pathogenesis of MS during CHD might help us modified hemodialysis technique in order to     prevent MS, and reduce the high cardiovascular mortality among CKD patients.   "
56553|NCT02545413|"     Irritable bowel syndrome (IBS) is the most common functional GI disorder in which abdominal     pain and/or discomfort is associated with changes in bowel habit, and with features of     disordered defecation. IBS affects 10-20% of the population and causes a marked reduction of     quality of life in affected individuals.The high prevalence of IBS is accompanied by large     societal economic burdens and negative effects on the quality of life in affected patients.     It is divided into 3 types IBS-D diarrhea predominant, IBS-C constipation predominant, IBS-M     mixed sub type.   "
56554|NCT02545400|"     This study aims to assess the frequency and severity of adverse events during Hepatitis C     therapy with or without first generation protease inhibitors.   "
56555|NCT02545387|"     Patients with hepatitis C show impaired neutrophil function. It is not known whether this is     a direct of an indirect phenomenon. Using bone marrow biopsies from patients with hepatitis C     it is possible to see whether neutrophil granulocyte progenitors are already infected with     hepatitis C.   "
56556|NCT02545374|"     Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds     compared with the usual care(with or without CICAT-LR Network).   "
56557|NCT02545361|"     The purpose of this study is to evaluate the safety and to determine the Dose Limiting     Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.   "
56558|NCT02545348|"     This is an obstervationnal study, to evaluate the good clinical practice of the use of the     sentinel node biospy in early stage endometrial cancer. The collaborating centres with the     OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc     will also particpate to the trial.      Sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading     team in the world published very good result and that the first prospectives trials are     already published with also excellents results. The investigators decided then to include     this practice in their institutional guideslines and also to registred the procedure.   "
56559|NCT02545335|"     The aim of this study is to characterize neutrophil function in patients undergoing chronic     hepatitis C triple therapy with protease inhibitors in comparison to dual therapy with     peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate     the possible mechanisms of protease-inhibitor associated infections.   "
56604|NCT02544750|"     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The     open-label extension phase only will be described in this record. All participants will     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or     increase the participant's dose until the optimal dose is found.   "
56563|NCT02545283|"     This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare     overall survival in participants with relapsed or refractory AML treated with idasanutlin in     combination with cytarabine versus participants treated with placebo and cytarabine.     Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle     1). Responding participants may continue to receive a maximum of further two cycles of     consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet     count recovery (CRp), overall remission rate (ORR), event-free survival (EFS), leukemia-free     survival (LFS) and percentage of participants with an allogeneic hematopoietic stem cell     transplant (HSCT) will also be compared between treatment arms. This study will include     participants with and without TP53 wild type (TP53 WT) mutations.   "
56564|NCT02545270|"     It is of great importance to obtain optimal surgical conditions for the surgeon in order to     increase patient safety. The effect of different interventions on surgical conditions has     been assessed by various surgeon-assessed rating scales. A 5-point surgical rating scale has     previously been tested in a proof-of-concept trial - but not validated - during radical     retropubic prostatectomy by asking different surgeons to evaluate the surgical workspace     using video sequences.      In an ongoing study (The Hernia Study, Trial registration NCT02247466) performed by     investigators group, investigators are using a 5-point scale to rate the surgical workspace     during laparoscopic ventral herniotomy with or without neuromuscular blockade. This scale is     based on previously used scales by already published studies and has a description connected     to each point. To the authors' knowledge the scale has never been validated in a laparoscopic     setting, where the intra-abdominal pressure during pneumoperitoneum can have a great     influence on visualization. In fact, to investigators knowledge, no validated     surgeon-assessed rating scale regarding the surgical workspace during laparoscopic surgery     does exists.      Purpose:      Primary aim:      To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations     of the surgical workspace at different intra-abdominal pressures. Using intra-abdominal video     recordings.      Secondary aims:      To validate a 10-point rating scale by investigating the inter-rater agreement of evaluations     of the surgical workspace at different intra-abdominal pressures.      To test the agreement between the two rating scales. To assess which of the two rating scales     has the highest inter-rater agreement To assess the intra-rater agreement of both rating     scales.      Hypothesis:      Investigators hypothesize that the 5-point rating scale has an intra-class correlation     coefficient (ICC) > 0.6., validated by video-sequences obtained during laparoscopic surgery.   "
56565|NCT02545257|"     The objective of this randomized controlled trial is to develop a coordinated,     multiprofessional medication management model for home-dwelling aged in primary care and to     study the effectiveness of this model. The main hypothesis is that the new model helps to     identify aged people having potential risks with their medications and thus allows solving     these risks.   "
56621|NCT02544529|"     The purpose of this study is to test the hypothesis that myopia progression can be slowed or     prevented by low dose Echothiophate Iodide.   "
56568|NCT02545218|"     The perineal body is commonly injured during labor. It is possible to perform a secondary     repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed     perineal tear. The aim of the randomized trial is to evaluate the results of such an     operation compared with conservative treatment.   "
56569|NCT02545205|"     The overall purpose of this project is to establish the added value of training with the     Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention     programs after stroke.      The main specific aims are:        -  to demonstrate the effect of training with HAL as part of current, best available,          regular inpatient rehabilitation in comparison with the effect of current, best          available regular inpatient rehabilitation programs only, in the post acute phase          (starting 4-7 weeks) after stroke with regard to gait and cardio-vascular function,          activity and participation;        -  to explore factors that predict outcome/good responders to training with HAL;        -  to estimate health care utilisation and cost effectiveness of using the HAL during the          first year after stroke.   "
56570|NCT02545192|"     The investigators propose to make the first observations of LFMS treating a population of     subjects with PTSD. A positive outcome for this study could translate directly into a new     treatment modality for symptoms of PTSD in both acute and chronic situations. The     investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in     the treatment of PTSD.   "
56571|NCT02545179|"     Purpose:Effect of web-based daily care training on the quality of life of caregivers of     children with cerebral palsy.      study design: Single-blind clinical trial. study population: Caregivers of children with     cerebral palsy. Inclusion criteria: caregiver -Mother of a child with cerebral palsy who     spent most time on child care- Children with cerebral palsy aged 4 to 12 years old living in     Alborz province that clinical diagnosis of cerebral palsy registered in their clinical     records. Moderate and severe cerebral palsy (gross motor function levels 3 to 5). caregiver     have facilities and basic knowledge of using Internet (Declared access to the Internet at     least one hour a week). exclusion criteria: taking care of two or more children with     disability. participated in previous face to face training programs.      Sample size: 100. Intervention: Web-based daily care training. intervention time: 12-week.     Outcome of the study: the quality of life of caregivers   "
56572|NCT02545166|"     This study will validate the sensitivity of a purine biosensor (SMARTChip) in detecting acute     cerebral ischaemia in a group of patients undergoing elective carotid endarterectomy. The     study will also investigate whether blood purine levels are indicative of future risk of     stroke by comparing pre-operative blood purine levels in carotid endarterectomy patients     (high risk group) and blood purine levels in a group of age and sex-matched controls.   "
56573|NCT02545153|"     Bile leak reduction from the common bile duct, as a result of glue appliance after     cholangiotomy.   "
56574|NCT02545140|"     The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk     assessment tool to identify those children with chronic disease risk factors (including Type     2 Diabetes).   "
56575|NCT02545127|"     This trial investigates the safety and efficacy of FE 202767 compared to placebo in     increasing milk production in subjects with preterm delivery and inadequate milk production.   "
56615|NCT02544607|"     Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has     been shown to last for up to one month. MRI technology will be used before and after ketamine     for patients with depression to examine the extent to which certain brain areas predict     ketamine's antidepressant effects.   "
56576|NCT02545114|"     Hyponatremia occurs frequently in patients with acute brain injury in the days to weeks     following injury, and may contribute to adverse outcome. In addition, hyponatremia can     aggravate neurologic dysfunction, complicate neurological assessments, and contribute to     neurologic symptoms such as gait dysfunction that can impair efforts at mobilization and     rehabilitation. Strict normonatremia (serum Na levels between 135 and 145 meq/dl) is the goal     in most patients with acute brain injury. SIADH is the most frequent cause of hyponatremia in     patients with neurological injury; however, treatment with fluid restriction is often     difficult or contra-indicated, for example in patients with subarachnoid hemorrhage (SAH)     where intravascular hypovolemia can trigger vasospasms. The aim of this project is to test     Tolvaptan, an ADH antagonist, as a treatment in selected patients with acute brain injury who     have developed SIADH.   "
56577|NCT02545101|"     This is a retrospective chart review non-interventional study designed to collect real world     data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia     secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.   "
56578|NCT02545088|"     The overall purpose of this project is to establish the added value of training with the     Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention     programs after stroke.      The main specific aims are        -  to demonstrate the effect of intensive training with HAL in comparison with intensive          training without HAL and with standard care only, in a later phase (1-10 years) after          stroke with regard to gait and cardio-vascular function, activity and participation;        -  to estimate health care utilisation and cost effectiveness of using the HAL during the          first year after stroke.   "
56579|NCT02545075|"     The purpose of this study is to determine whether Ipilimumab will extend the life of chinese     patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to     examine safety in this patient population.   "
56580|NCT02545062|"     T2D and cognitive impairment are two of the most common chronic condition found in persons 60     years and older. Diabetes type 2 increases with age and studies suggest that the diabetes is     one of the risk factor for cognitive impairment and dementia.      Although there is much recent research showing that diabetics at every age have more     cognitive impairment and dementia than non-diabetics, relatively little attention has been     paid to the implications of this complication in the management of T2D in terms of screening,     prevention, education and treatment adherence.      There are now guidelines for periodic evaluation of patients with diabetes as early detection     of complications of the disease, but so far there are no similar assessment and monitoring of     cognitive function.      In this study the investigators examine cognitive function in young diabetic patients (from     20 to 55) using the MoCa test, that allows detection of mild cognitive impairment, and may be     carried out during a visit, an annual advisory diabetes clinic.   "
56582|NCT02545036|"     The annual report of USRDS shows than Taiwan has the highest prevalence of     end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors     associated with chronic renal failure are age, diabetes, hypertension, chronic     glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic     kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And     these possible prognostic factors associating with the disease progression and ultimately     increase the morbidity and mortality. End-stage renal failure is an irreversible course often     with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often     use Chinese medicine or acupuncture to help them to ease the symptom.      The aim of this study is to investigate the efficacy of combined Western medicine and     traditional Chinese medicine daycare model for chronic kidney disease patients. The study     approach to investigate whether combination of Western medicine and traditional Chinese     medicine daycare model can improve the clinical symptoms and quality of life as well as the     laboratory biochemistries data.   "
56583|NCT02545023|"     This phase I/II research trial studies supportive care questionnaires in gathering data on     unmet needs and health-related quality of life in Latina breast cancer survivors after     surgery, chemotherapy, or radiation therapy. Questionnaires that address unmet supportive     care needs and health-related quality of life of breast cancer survivors may help doctors     learn about barriers to cancer care that are linked to language, acculturation, knowledge     about diagnosis and care, and financial concerns. Learning about unmet needs of breast cancer     patients may help increase quality of life and decrease healthcare utilization and costs.   "
56584|NCT02545010|"     Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic malignancies     and is the fifth leading cause of cancer death in women in the United States.1 Despite     initial high response rates, 50% to 75% of women who present with advanced disease suffer     relapse and require re treatment2.The optimal treatment for platinum resistant ovarian cancer     remains hotly debated. Combination chemotherapy is not favored due to its increased toxicity     and lack of convincing benefit when compared to single agent chemotherapy.3,4 Recently, the     addition of bevacizumab to single agent chemotherapy in the AURELIA study improved     progression free survival (PFS) from 3.4 months to 6.7 months. Response rates were also     improved from 11.8% versus 27.3% (p= 0 .001).9 Aim: To determine the maximal tolerated dose     (MTD) of weekly paclitaxel in combination with LDWART. The recommended phase II dose (RP2D)     will be based on the MTD in this Phase I study. Method: This study is designed as a     prospective, single arm phase I study with 3+3 with dose de-escalation and cohort expansion.     All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2,     60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard     practices. Cycles of chemotherapy will be administered weekly without interruption on Days     1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART(Fig.1). LDWART will     be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter     fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.(Fig.1).     Importance of proposed research: The combination of a LDWART with weekly paclitaxel may     improve the efficacy of the current standard weekly paclitaxel in platinum resistant ovarian     cancer patients. Potential benefits and risks: The combination may improve treatment     response. Adding LDWART may increase treatment risks, but these will be monitored closely.   "
56616|NCT02544594|"     This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus     standard treatment alone in patients with cardiogenic shock due to myocardial infarction.   "
56882|NCT02541084|"     This study aims at investigation of the caregiver burden of Wet Age-related Macular     Degeneration (wAMD) patients and at the assessment of how much of caregiver burden could be     reduced in transitioning from Pro Re Nata to proactive therapy especially in real-life rural     settings where public transportations are not readily available.   "
56587|NCT02544971|"     Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many     individuals exposed to aversive events. The severity of PTSD symptoms is positively     correlated with amygdala activation. More severe PTSD symptoms following exposure to     stressful events, are associated with amygdala hyper-responsivity prior to exposure. A     possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned     self-modulation of neural activity in response to feedback of neural signal. Previous work in     our lab established a NF training procedure that utilizes the temporal abilities of EEG with     the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD     signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to     self-regulate amygdala activity and to improve emotional regulation in a healthy population.     The current study aims to investigate the potential of this method as a therapeutic     intervention for PTSD.   "
56588|NCT02544958|"     To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment     of enlarged pores.   "
56589|NCT02544945|"     This is a cohort study of 16 women undergoing post-mastectomy chest wall radiotherapy for     breast cancer comparing two ways of modifying the radiation beam with bolus (a 5mm rubber     substance placed on the skin to modify the radiation beam). The hypothesis is that 3D printed     bolus will conform more closely to the chest wall than standard 5mm-thick standard bolus and     thus lead to less chance of underdose or overdose of the skin. Each patient will receive the     standard dose of radiotherapy, but half the treatments will use standard bolus and half the     treatments will 3D printed bolus (ie each patient will act as is their own control). The     primary outcome is the comparison of the amount of air under the bolus for each technique.     Secondary outcome is the amount of time it takes to set up the patient for radiotherapy.   "
56590|NCT02544932|"     Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including     endothelial dysfunction of heart and vessel. This study was designed to determine the     efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of     atherosclerosis of AF subjects.   "
56591|NCT02544919|"     To study the impact of pretreatment of living donor liver transplantation recipients with     SMOF lipid on the incidence and severity of post-transplantation neurological complications     in patients receiving tacrolimus based immunosuppression protocol   "
56592|NCT02544906|"     The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in     LDLT recipients   "
56593|NCT02544893|"     we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine     for ultrasound guided thoracic paravertebral block in thoracotomy   "
56594|NCT02544880|"     The investigators hypothesize that Tadalafil treatment, by lowering Myeloid Derived     Suppressor Cells (MDSCs) and regulatory T cells (Tregs), can prime an antitumor immune     response and promote a permissive environment that should increase the efficacy of anti-tumor     vaccine in a setting of minimal residual disease.   "
56595|NCT02544867|"     An emerging body of epidemiological evidence suggests that various forms of sedentary     behavior, including TV viewing, occupational sitting, and total daily sitting, may be     associated with all-cause and cardiovascular mortality, overweight and obesity, type 2     diabetes, depression and psychological well-being. Importantly, many of these associations     were independent of participation in moderate to vigorous intensity physical activity. We     propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of     two interventions targeting sedentary behavior. Since it is currently unknown what component     of sedentary behavior exposure presents the greatest risk to health, we propose separate     interventions to reduce overall sedentary time and to promote breaks in sedentary time.   "
56596|NCT02544854|"     By measuring plasmatic concentration of propofol at different intervals during surgery of     children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for     cerebral activity, the investigators aim to create a pharmacokinetic/pharmacodynamic model of     propofol for children.   "
56597|NCT02544841|"     The purpose of the study is to determine the impact of the offer to participate in Safer Sex     Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health     (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and     frequency of sex) six months after the end of treatment.   "
56598|NCT02544828|"     The objective of the present study is to determine the impact of intraoperative IV-iron     supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2     ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb     arthroplasty surgery.   "
56599|NCT02544815|"     AHFS management is challenging and most of the used drugs has failed to decrease     post-discharge mortality and readmission rates which represent the most important goal in     AHFS.      Digoxin processes many characteristics of a beneficial drug for heart failure, however recent     publications has rose concerns about its safety profile and therefore decreasing its use.      Whether digoxin is efficient and safe in short term treatment of acute heart failure is a     question that should be studied.   "
56600|NCT02544802|"     The purpose of this study is to evaluate the safety and preliminary efficacy of autologous     adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary     osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed     to subjects at a weekly interval.   "
56601|NCT02544789|"     Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are     dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate     the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients     with R/R ALL   "
56602|NCT02544776|"     On the basis of the current study, amlodipine seems to be a promising drug on improving     uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level and     pregnancy outcome in patients with pco.   "
56603|NCT02544763|"     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The     blinded phase only will be described in this record. Participants will receive 1 of 2 doses     of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a     difference between GWP42003-P and placebo in their effect on seizure frequency.   "
57000|NCT02539485|"     The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on     respiratory mechanics and sore throat was investigated.   "
56605|NCT02544737|"     Patients with esophageal cancer that had metastatic lesions after been treated with surgery     or definitive chemoradiotherapy are being asked to participate in this study.      Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine     kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of     vatalanib or sorafenib.      The purpose of this study is to determine what effects apatinib has on metastatic esophageal     cancer. These effects include whether apatinib could shrink the tumor or slow down its growth     and what side effects apatinib will have on the tumor.   "
56606|NCT02544724|"     NM-IL-12 is being evaluated as an immunotherapeutic with concomitant hematopoietic     regenerating properties for treatment of relapsed/refractory DLBCL, an aggressive type of     B-cell non-Hodgkin's lymphoma (NHL). Determination of the maximum tolerated dose (MTD) for     NM-IL-12 is not planned in this study, rather, a pre-defined dose of 150 ng/kg will be     explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy     volunteers.   "
56607|NCT02544711|"     Primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare     pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases     in France per year).      The reference treatment is a surgical en bloc resection associated or not to a medical     treatment. This surgery remains highly challenging because of the complex three-dimensional     geometry of the pelvic bone and the proximity of important organs and neurovascular     structures. The local recurrence rate is significantly increased when the resection does not     respect a safe tissues margin (R0 margin).      A new technology has been developed and used in different reference sites the Patient     Specific Instrument (PSI), manufactured by 3D-Side. The PSI allows for a more secure and     reliable surgical gesture, leading to more frequent R0 margins.      The main objective of this study is to compare the efficiency of the PSI for bone tumor     resections within the pelvis with respect to the reference method.   "
56608|NCT02544698|"     This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People     Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years     and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and 2-5 years     old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will receive 3     doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.   "
56670|NCT02543892|"     This study will determine if PATH-wSP, a vaccine against a germ that causes pneumonia, is     safe and induces immune responses in adults and toddlers. The study vaccine will be compared     to placebo. First adults will receive a 2 injections of a lower dose of the vaccine or     placebo, 28 days apart. If the lower dose is safe, then a higher dose will be tested. Once     the safety is established in adults the lower and higher dose will be tested in toddlers,     starting with the lower dose.   "
70095|NCT02368314|"     The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan     for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.   "
56609|NCT02544685|"     Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer     patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the     main sources of infections during neutropenia. Competitive inhibition of gut mucosal     colonization by pathogenic microorganisms using synbiotics could represent one of the     potential options for its prevention. Synbiotics represent combination of two components:     probiotics and prebiotics. Probiotics are live microorganisms, which in form of drugs or food     supplements administered at a sufficient dose help to maintain health beneficial microbial     balance in the digestive tract of a human or other host. Prebiotics are food ingredients     nondigestible for our digestive enzymes, but can be fermented by bacteria in our bowel and     this way selectively stimulate growth or activity of specific saccharolytic bacterial     strains. These changes in composition of our microflora may bring benefits on host well-being     and health. Based on the results of human and animal studies, probiotics probably can not     only decrease the level of gut colonisation with pathogenic bacteria, but may also lead to     reduction in the duration of neutropenia, accelerate the restitution of the intestinal mucosa     and boost immunity. Despite a significant number of studies on probiotics still only little     evidence of their safety especially in immunocompromised patients is available.      To help find new options for increasing quality of healthcare for children cancer patients     and also to evaluate safety of this new approach investigators designed double-blinded     placebo controled multicenter study aimed to decrease the number of febrile episodes using     prevention with synbiotic.   "
56610|NCT02544672|"     The objective of this study is to evaluate the functional benefits of a myoelectric     Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular     accident (CVA).   "
56611|NCT02544659|"     This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone     marrow edema in patients with SAPHO syndrome.   "
56612|NCT02544646|"     It has been hypothesized that the biomechanical properties of the optic nerve head and/or     sclera play a role in the development of glaucoma. One approach of gaining insight into the     biomechanical properties of the eye by the means of clinical studies is based on the     Friedenwald equation, representing a pressure-volume relationship. This equation represents     the so called ocular rigidity, which expresses the elasticity of the globe.      In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA)     with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude     (PA) have to be performed.      In addition choroidal thickness will be assessed with OCT before and after trabeculectomy,     since results in choroidal thickness measurements in patients with glaucoma are     controversial.      The focus of this study lies on the changes of ocular rigidity and choroidal thickness after     surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or     pseudoexfoliation glaucoma (PEX).   "
56613|NCT02544633|"     MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and     other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced,     unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic     changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing     for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have     previously received treatment with chemotherapy. The number of patients to be enrolled will     depend on how many enrolled patients experience tumor size reduction. MGCD265 will be     administered orally, twice daily. The study is designed to evaluate whether the number of     patients experiencing tumor size reduction is substantially higher than would be expected     with other available treatments.   "
56614|NCT02544620|"     The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement, Total     Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The     design is as an observational prospective study, evaluating patients that fulfil discharge     criteria on the day of the surgery. The investigators will further evaluate safety aspects,     such a early morbidity and mortality, as well as patient satisfaction.   "
56617|NCT02544581|"     This is an exempt, retrospective study of a limited set of information obtained from     patients' medical records at 10 to 12 substance abuse treatment programs combined with     alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study     objectives are 1) to compare the compliance rates and likelihood of achieving sustained     sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated     monitoring programs and 2) identify components within patients' monitoring agreements that     are significantly correlated with positive outcomes.   "
56618|NCT02544568|"     Meal composition is important for blood sugar levels in patients with diabetes. The aim of     this study is to investigate if a meal composition of fat, protein and carbohydrate is     important for the hormonal and inflammatory responses Patients with type 1 and type 2     diabetes and healthy controls will be included in the study. At four different occasions the     participants will receive lunch with the same amount of calories but different composition of     fat, protein, carbohydrate and fiber. Blood samples will be taken before and after the meals.     The participants will estimate their satiety. In addition participant will fill in     questionnaires about their food habits and wellbeing.      This study is the first study to compare both hormonal and inflammatory responses, as well as     psychological aspect of the meals, after meals with different composition. Results from this     study will help to make recommendation about meal composition which is beneficial for     patients with diabetes type 1 and type 2.   "
56619|NCT02544555|"     There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial     lesion with guide wire. One is the intraluminal approach of passing guide wire through the     atheroma, the other is the subintimal approach of passing wire through the subintima of the     vessel.      Either of these two interventional technique can be chosen depending on the character of the     lesions they have their own pros and cons which affects the success of the intervention. The     study is limited to retrospective studies to which interventional technique is better for     post-procedural recurrence rate, however there is no prospective randomized controlled study.   "
56620|NCT02544542|"     This study will try to evaluate the effectiveness and safety of a new method for achieving     mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be     treated by the widely-used hyper-hypothermia blanket method, while the other half will be     treated by the investigators' new method.   "
56622|NCT02544516|"     In schizophrenia, dislocation of psychic functions involving a loss of contact with reality     is frequently found. A fragmentation of motor and sensory perceptions could be held     responsible (Fuchs, 2005). However, automatic integration between perception and action is     the necessary condition to be in relationship with the world. Affordance is the     experimental link between object perception and actions potentially associated (Gibson (1977,     1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual     motor neurons leads us to postulate that the affordance effect can be assisted by a     visuomotor priming of a hand in a position to grasp. With Tucker & Ellis sensory motor     compatibility task, we study the capacity of affordance in schizophrenia, as well as the     impact of perceptual motor priming on these affordance effects.   "
56623|NCT02544503|"     The purpose of this study is to identify and establish how the area of the brain that     controls motor function (motor cortex) might serve as a new focus for treatment for stroke.     The therapeutic intervention aims to identify protocols that improve motor performance after     stroke.   "
56624|NCT02544490|"     The objectives are to:        1. derive and validate a panel of miRNAs that are consistently differentially expressed in          the plasma of patients with and without sepsis        2. investigate the prognostic and predictive values of the panel of miRNAs to guide          treatment        3. investigate the roles of these differentially-expressed circulating miRNAs in immune          modulation during sepsis      The methodology involves sampling of blood from controls and subjects in the sepsis continuum     at their earliest presentation in the emergency department longitudinally to hospitalization.     The investigators will develop panels of miRNAs that are specific to early and late stages of     sepsis, and correlate clinical, biochemical and microbiological outcomes with these miRNAs.   "
56625|NCT02544477|"     The primary objective of this study is to evaluate the impact of early preventive application     of HFNCO versus conventional oxygen therapy in patients after thoracotomic lung lobectomy   "
56626|NCT02544464|"     The objective of the present study is to determine the impact of intraoperative IV-iron     supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2     ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb     total knee arthroplasty surgery.   "
56627|NCT02544451|"     Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic     fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator     (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233).     Study 110 is designed to evaluate the safety and efficacy of long term treatment of     lumacaftor in combination with ivacaftor.   "
56628|NCT02544438|"     A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of     Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid     Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) disease   "
56629|NCT02544425|"     Open-labeled, multicenter phase II study of VIDL (VP-16, Ifosfamide, Dexamethasone,     L-asparaginase) chemotherapy followed by high-dose chemotherapy and autologous stem cell     transplantation in patients with stage III/IV extranodal NK/T-cell Lymphoma.   "
56630|NCT02544412|"     The purpose of this project is to study whether a mindfulness-based training program supports     self-regulation, resiliency, effective classroom behaviors, and persistence in teaching.   "
56643|NCT02544243|"     Development of an active second-line treatment option for metastatic breast cancer patients     previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative     settings.For each randomisation arm, 100 patients will be included. The trial was performed     as a 2-stage phase II study according to the optimal design by Simon with overall response     rate as the primary objective.      Study Design:      Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25     mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks   "
56631|NCT02544399|"     After the age of 50, one in three women and one in eight men will experience at least one     fragility fracture during the rest of their lives. It is currently recognized that physical     activity has an osteogenic actions, especially when it includes the impact transmitted to the     skeleton. In this context, the investigators propose a study to determine whether the regular     practice of golf could be particularly beneficial for the skeleton, not only in the lower     limbs, due to repeated impacts to the ground when it requires sustained walking, but also the     upper limbs due to the impacts transmitted by the club at the time of striking the ball, as     has been amply demonstrated with racquet sports.   "
56632|NCT02544386|"     In hemiplegic, there is very little data on the impact of neurological deficit on the     microarchitecture independent of bone mineral density and composition of the bone marrow.     Rare studies have shown the relationship between some micro-architectural parameters and     severity of neurological deficit. There is no study in humans on the evolution of the     parameters of the microarchitecture assessed by 3D micro-tomography in the early phase of the     installation of neurological deficits after stroke, in terms of a bearing bone, tibia, that a     non-load bearing bones, radius.   "
56633|NCT02544373|"     The objectives of this study are to determine the effects of obstructive sleep apnea (OSA) on     cognitive function in patients with multiple sclerosis (MS); and to evaluate whether OSA     treatment with positive airway pressure therapy could improve cognitive dysfunction in MS     patients who have OSA.   "
56634|NCT02544360|"     The purpose of this study is to determine whether photoaging mobile app promoting poster     campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is     measured via questionnaire.   "
56635|NCT02544347|"     The aim of the present study were 1) to determine the role of these adipokines in the     pathogenesis of periodontal disease, inflammation and tissue destruction comparing with     gingival crevicular fluid (GCF) levels of TNF-α, which has a known pro-inflammatory effect in     periodontal disease, 2) to investigate the effect of non-surgical periodontal treatment on     GCF vaspin and omentin levels in type 2 diabetic (T2DM) patients with Chronic Periodontitis     (CP).   "
56671|NCT02543879|"     This is an open-label, multicenter, dose-escalation Phase 1 study in patients with acute     leukemia/high-risk MDS or non-Hodgkin Lymphoma, intended to investigate safety,     pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more     intermittent dosing schedules. Once the MTD has been established, up to 56 additional     patients may be enrolled in 4 expansion cohorts in selected patient populations at the     recommended dose for future studies to confirm safety.   "
56636|NCT02544334|"     Rheumatoid Arthritis (RA) is a chronic and potentially severe autoimmune disease affecting 2     million in the United States. The role of environmental factors in modulating autoimmunity     pathogenesis has been clearly described and yet the specific mechanisms of action remain     poorly understood. A growing body of evidence implicates microbiota of mucosal surfaces in     the development of autoimmune disorders. Various studies have clearly linked RA to     periodontal disease. The latter is linked to the red-complex that includes the oral bacterium     Porphyromonas gingivalis. And yet there has not been a systematic analysis of the oral     microbiota in RA to determine whether there are specific markers for P. gingivalis (and other     oral bacteria) that are linked to RA.      In this study, the investigators will characterize oral microbial composition (microbiome)     and gene content (metagenome) of DNA isolated from oral samples obtained from patients with     (i) early stage RA prior to biologics treatments and (ii) subsets of RA patients who are     responsive or unresponsive to anti-TNF-alpha therapy. The innovative aspect of this study is     going beyond the identification of oral bacterial species, to the level of strains and genes     that are associated with these groups. The overall hypothesis is that oral microbial     variation exists between individuals that influences development of autoimmunity and     autoimmune disease.   "
56638|NCT02544308|"     The purpose of the trial is to establish whether adjuvant therapy with lenalidomide +     dexamethasone after radiotherapy can improve progression free survival in patients with high     risk solitary bone plasmacytoma compared with RT only.   "
56639|NCT02544295|"     The objective of this research is to develop original virtual reality scenarios and/or new     virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit     disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies     interfering with sleep/wake disorders.   "
56640|NCT02544282|"     In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with     axillary node dissection will be randomly assigned to general anesthesia with opioids     combined with a Pecs II block or to general anesthesia with opioids combined with a placebo     Pecs II block. Participants will be followed postoperatively during their entire hospital     stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block     and opioids as postoperative pain treatment.   "
56641|NCT02544269|"     The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal     anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade     and the other half will receive continuous spinal anesthesia.   "
56642|NCT02544256|"     The purpose of this study is to determine whether mild hypothermia causes reduction of     vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow     in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of     vasospasms during the period of 14 postoperative days measured by transcranial Doppler.   "
56644|NCT02544230|"     The investigators retrospectively evaluated the efficacy of granulocyte transfusions as     adjunctive treatment for severe infections in neutropenic fever unresponsive to antimicrobial     therapy in hematological patients.   "
61027|NCT02486770|"     This study will evaluate the safety profile and pharmacokinetic behavior of a single     administration of Aerucin in healthy adults at three different dosages.   "
56645|NCT02544217|"     Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders     affecting both children and adults. KH176 is a novel chemical entity currently under     development for the treatment of inherited mitochondrial diseases, including MELAS     (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease     and LHON (Leber's Hereditary Optic Neuropathy). KH176 is a potent intracellular redox     modulating agent targeting the reactive oxygen species which are important in the     pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a     favourable safety profile in the pre-clinical testing, the safety, tolerability and     pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in     healthy male subjects in this trial   "
56646|NCT02544204|"     To investigate the efficacy of the administration of JVS-100 delivered via direct     intramuscular injections on a 3 month and 6 month composite endpoint of wound progression,     healing and limb loss in patients with severe peripheral arterial disease with non-healing     chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of     infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.   "
56647|NCT02544191|"     Preliminary reports showed that hormonal treatment may improve the chance of retrieving     viable testicular sperm from men with NOA. It was generally believed that gonadotrophin     treatment would be ineffective in the presence of high plasma levels of endogenous     gonadotrophin.The purpose of this study is to determine whether GnRHa(gonadotropin-releasing     hormone agonist) combined with hCG(human chorionic gonadotropin) and hMG(human menopausal     gonadotropin) are effective in the treatment of non-obstructive azoospermia.   "
56648|NCT02544178|"     The survival time and the number of long time survivors after radiotherapy in brain cancer     patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic     effects of this therapy gains more and more importance. Among these side effects, the main     and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the     white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence     rate assessment, as well as the occurrence time, is based on retrospective studies with low     numbers of patients, but seems to reach 30 to 50 % of the patients according to the     follow-up. The risk seems to be increased during the first two years after the radiotherapy,     but persists for decades.      To gain further insight in the radiation-induced leukoencephalopathy, the objective of this     project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective     cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using     specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive     bio-markers of cognitive impairments.   "
56649|NCT02544165|"     The aim of this study was to investigate the difference in accumulation of AGEs (advanced     glycation end-products) in the tissues of individuals who smoke in comparison with     individuals who do not as well as of individuals who consume caffeine versus those who do     not, and finally to examine the probable differences concerning participants' haemodynamic     parameters.   "
56650|NCT02544152|"     A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.   "
56651|NCT02544139|"     This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard     reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.      The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the     qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole     blood samples. Reactive assay results are presumptive evidence of Chagas infection.      This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas     infection. A fingerprick blood sample and a venous blood sample (for processing to serum)     will be collected from each subject. Subject age, gender, and symptoms will be recorded. For     this study, samples will have no personally identifiable information.      CDP and reference tests will be performed by different operators who are laboratory staff     members. These staff members, blinded to each other's results, will evaluate the samples from     each method independently.   "
56652|NCT02544126|"     The purpose of this study is to investigate how working with a computer program may affect     mood, feelings, overall health, and markers in blood in young adults with HIV.   "
56653|NCT02544113|"     This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult     patients receiving a single organ liver transplant from a deceased donor; the purpose being     to determine the efficacy of Thymoglobulin® induction and delayed initiation of CNI in the     long-term preservation of renal function after liver transplantation. This study is based on     the outcomes of an earlier phase 1 pilot study which was performed at the Cleveland Clinic.      This study will be conducted at 3 centers, with 110 subjects randomized 1:1 into two groups:     Group 1 will receive Thymoglobulin® induction, (4.5 mg/Kg, in 3 doses of 1.5 mg/Kg/dose) with     delayed initiation of CNI to begin on Day 10 post LT. Group 2 will receive early CNI     initiation (to be started no later than Day 2 post LT), and no Thymoglobulin® induction (or     any other antibody).      All subjects will also receive a maintenance immunosuppressive regimen consisting of     corticosteroids and mycophenolate mofetil (MMF) according to standard of practice in     orthotopic liver transplantation (OLT).      Subjects will be consented pre-transplant. Participation may last up to 12 months post OLT.     There are 15 study-related visits which will be completed during standard of care (SOC)     visits.   "
56654|NCT02544100|"     The purpose of this study is to create a neonatal neurologic biological big data center named     Neonatal Neurologic Intensive Care Network in China with neonatal systematic information,     biological samples and genomics & genetic data on neonates born with neonatal severe     encephalopathy. It also can predict brain injury as cerebral function monitoring through big     data and recommend appropriate treatment. In addition, the following samples will be     collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (CSF)     samples.   "
56655|NCT02544087|"     The present study is designed to confirm the therapeutic effects of heat-clearing and     blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI)     and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action     involved from the standpoint of pathology, cell and molecular biology, as well as immunology.   "
59865|NCT02501967|"     The purpose of the proposed project is to pilot-test in the clinic setting a computer-based     clinical decision support system (CDSS) designed to optimize medication prescribing for older     persons with multiple chronic conditions and polypharmacy.   "
56656|NCT02544074|"     The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive     assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia.     SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable     forms allows it to be given in almost any setting, does not require any staff time to     administer and makes it practical to rapidly screen large numbers of individuals in the     community or in their home.This trial is being conducted to study the validity of SAGE in a     digital format (eSAGE) for cognitive screening.      The investigators will analyze the data to learn the correlations between eSAGE and gold     standard neuropsychological testing designed to differentiate normal cognition from MCI and     early dementia. The investigators will also find out whether the paper (SAGE) and electronic     (eSAGE) versions of SAGE could be used interchangeably or not.   "
56657|NCT02544061|"     The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to     standard of care (SOC; control) in subjects with open surgical wounds.   "
56658|NCT02544048|"     Background:      People with malaria often show altered immune responses to many illnesses and vaccines. This     means that the malaria might cause immune suppression. It is not clear how or which vaccines     are impacted by malaria. It is also not clear if the impacts are such that people should be     preemptively treated before they get vaccinations. Researchers want to see if there is a link     between taking an antimalaria drug prior to getting vaccines and the immune response to those     vaccines. To do this, they will study people who are taking part in certain NIAID studies.      Objectives:      To compare the proportion of PD1+ CD4 T cells among all T cells in vaccine immune responses     in adults who have or have not received antimalarials prior to getting a Menactra vaccine.      Eligibility:      Healthy Malian adults who:      Were previously enrolled in NIAID Protocol 13-I-N109 or 15-I-0044      Reside in Bancoumana and neighboring villages      Are not pregnant      Design:      Participants will be screened with a physical exam.      Participants will get the vaccines listed below as part of Protocol 13-I-N109 or 15-I-0044.     This study will follow their schedule.      At each visit, participants will give a blood sample. They will also have a physical exam.     Each visit will last 1 to 2 hours.      At visit 1, participants will get a hepatitis vaccine.      Two weeks later, participants may get the antimalarial drug Coartem . They will be chosen at     random.      Two weeks later, participants will get Menactra .      Participants will have 5 follow-up visits after they get Menactra .      The study will last up to 4 months.   "
56672|NCT02543866|"     This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to eradicate     intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae in     pediatric patients.      FMT will be performed on subjects with a history of at least one infection due to ESC-R     Enterobacteriaceae.      This protocol aims to determine the feasibility, safety, tolerability, and potential efficacy     of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.   "
56673|NCT02543853|"     The purpose of this study is to determine effect of veres needle entry and direct trocar     entry on postoperative gastrointestinal functions.   "
56659|NCT02544035|"     Background:      Play during childhood is an important part of healthy development, and children can learn     many things when they play. Much of the time that children spend playing is with toys.     However, children at different ages need different types of toys to engage in healthy play.      Understanding children s play with toys is important to the National Institute of Child     Health and Human Development (NICHD), and to the U.S. Consumer Product Safety Commission     (CPSC). The CPSC rates toys that are currently available in the United States for children     for age appropriateness. NICHD will share the findings of this study with CPSC to aid in     their toy rating process.      Objective:      To categorize traditional and contemporary children s products and toys into age appropriate     groups.      Eligibility:      Healthy children 6 months to 12 years old.      Their parents.      Design:      Participants will be screened with a phone call with the parents.      Participants will complete surveys online or on paper, and by phone. These will ask about     demographic facts, behavior, thoughts on parenting and toys, and child development.      Participants will have 1 study visit. The child will play with toys by himself or herself.     Then they will play with their parent. A researcher will observe. The sessions will be     videotaped.      Children will share their thoughts about the toys by pointing at a smiley face scale.      Parents will fill out a short survey. Then can choose to participate in a 1-hour focus group.   "
56660|NCT02544022|"     Background:      People with neurofibromatosis 1 (NF1) who have plexiform neurofibromas (PNs) can have pain     that affects their daily lives. This study aims to improve questionnaires that measure their     pain, daily living, and physical functioning.      Objectives:      To examine and improve questionnaires about daily living for people with NF1 and PNs.      Eligibility:      People ages 5 and older with NF1 and a PN      Design:      Participants will be screened with medical history.      This study will have 2 phases.      Phase 1 participants will talk about existing pain assessment questionnaires and how PNs     affect their life. They will have group discussions of up to 8 people of a similar age with     NF1 and PNs, or the parents of children with it. These will last about 90 minutes. Children     ages 5 to 7 and their parents will have one-on-one meetings instead. These will last about 45     minutes. Discussions will be audiotaped. After the questionnaires have been changed,     individual interviews will discuss the new wording, instructions, questions, and electronic     format of the new forms.      Phase 1 participants may be invited to Phase 2.      Phase 2 participants will complete the new questionnaires. These may be pen-and-paper or     electronic. The questionnaires will take about 30 minutes for adults and teens. Children will     work one-on-one with a staff member and may need up to 45 minutes. A small group of     participants will be complete the forms twice in clinic and 1 month later at home. Also, a     small group who start a new pain treatment or have a dose increase in their treatment will     complete the forms twice before the treatment change and 1 month later.   "
56668|NCT02543918|"     The purpose of this study is to compare the body's immune response when vaccines are given     alone versus when vaccines are given along with the study drug called ixekizumab. The     vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with     follow-up at 12 weeks.   "
56703|NCT02543450|"     In hemiplegic stroke patients, gait performance is affected by impaired walking endurance.     Evidence has shown that higher exercise intensity improves cardiovascular fitness, while     greater dose in task repetition benefits locomotor function. Therefore, the goal of this     study is to examine the effect of a combined cardiovascular/task-oriented interval training     programme on the walking capacity of chronic stroke individuals and the improvement in their     participation.   "
56704|NCT02543437|"     The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger     diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance     for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the     Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is     to observe wear resistance performance of X3 over historical liner existing highly     crosslinked polyethylene.   "
56661|NCT02544009|"     Background:      Many people regain the weight they lose through diet and exercise. This might happen because     the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may     cause people to regain weight if they do not keep up high levels of exercise or major caloric     restrictions. Researchers want to find the long-term effects of metabolic adaptation in the     previous Biggest Loser study participants. They hope to learn the body s response to     lifestyle changes that result in weight loss. They also want to see if certain changes can     lead to longer-term success in maintaining weight loss.      Objectives:      To better understand the long-term metabolic changes caused by rapid weight loss achieved     through diet restriction and vigorous physical activity.      Eligibility:      Former Biggest Loser research study participants (Protocol No. PBRC29008).      Design:      Participants will be screened with a phone interview.      This study has 3 phases.      Phase 1 will last at least 3 weeks. Participants will receive a physical activity monitor and     wireless scale. These will send their daily weight and activity back to NIH.      In Phase 2, participants will stay at NIH for 3 days. Their metabolism will be measured     through:      Their activity monitor      Urine samples and daily body weight      Medical review and physical exam      Fasting for 12 hours each night for a blood draw the following morning      DEXA: a low-dose x-ray of the body      BIS: Electrodes on the hand/wrist and foot/ankle measure body water content.      Phase 3 will last at least 3 weeks. Participants will:      Continue to monitor their daily weight and activity      Collect urine samples and send them back to NIH   "
56683|NCT02543710|"     MoMaTEC2 aims to test, in clinically oriented studies, the applicability of already     identified and promising molecular biomarkers, to promote individualisation of treatment for     patients with endometrial cancer. Predominantly, but not exclusively, such biomarkers have     shown to be interesting in retrospective analysis of our large prospectively collected     MoMaTEC1 series.      Part 1: Performance of a phase 4 implementation trial for optimised stratification of     surgical treatment, specifically the performance of (para-aortic and pelvic) lymphadenectomy     guided by validated biomarkers.      Part 2: Performance of a phase 2b clinical biomarker study to evaluate the predictive     potential of the biomarker stathmin for taxane treatment response in endometrial and ovarian     cancer. In this study stathmin will be used as integrated biomarker.   "
58438|NCT02520674|"     The purpose of this study is to assess the accuracy and reliability of smartphone     ophthalmoscopy compared to slit-lamp biomicroscopy in glaucoma screening for potential     community screening programs.   "
56662|NCT02543996|"     Background:      Studies show that rare genetic variants might lead to diseases. Researchers want to collect     blood and tissue samples so they can study them and better understand diseases.      Objective:      To collect blood and tissue samples for studies to identify underlying causes of disease.      Eligibility:      People of all ages      Design:      Participants will have blood and/or tissue samples collected.      Samples can be collected at the NIH Clinical Center. Participants doctors can collect the     samples and send them to NIH. NIH staff can collect samples off site.      For blood samples, blood is taken from an arm vein using a needle.      Tissue collection may involve:      Buccal smear: Cells are collected by scraping the inside of the cheek with a cotton swab.      Saliva collection: Participants spit into a cup.      Skin biopsy: A special needle takes a very small skin sample.      Surgical waste tissue: If participants have surgery, NIH may receive samples of tissue that      would routinely be removed.      Umbilical cord or cord blood collection: If a participant has a baby, NIH may receive a      small piece of the umbilical cord or blood from the cord once the baby is delivered.   "
56663|NCT02543983|"     Background:      There are no good treatments for people considering suicide. Researchers want to study     suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better     understand suicide, so they can help suicidal people.      Objective:      To understand what happens in the brain when someone has thought about or attempted suicide.      Eligibility:      Group 1: Adults ages 18 70 who have thought about or attempted suicide recently      Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past      Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about     suicide      Group 4: Healthy volunteers the same ages.      Design:      Participants will be screened in another protocol. Adults who have recently thought about or     attempted suicide must be referred by a doctor. They may do up to 3 phases of this study.     Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.      Phase 1: 1 week in hospital. Participants will have:      Physical exam.      Questions about thoughts and feelings.      Thinking and memory tests and simple tasks.      Blood and urine tests.      Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes     pictures. They will have a coil over their head and earplugs and do a computer task.      Sleep test. Disks and bands will be placed on the body to monitor it during sleep.      Magnetic detectors on their head while they perform tasks.      A wrist monitor for activity and sleep.      Lumbar puncture (optional). A needle will collect fluid from the back.      Shock experiments (optional). Participants will observe pictures and sounds and feel a small     shock on the hand.      Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood     draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1     tests.      Phase 3: up to 4 more ketamine doses over 2 weeks.      Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5     years.   "
56664|NCT02543970|"     The primary objective of this study is to confirm the safe and effective use of the Celluma3     for the reduction in the appearance of periorbital wrinkles.   "
56665|NCT02543957|"     An Endoscopic retrograde cholangio pancreatography (ERCP) with cholangioscopy (endoscope to     directly visualize the bile duct ) is a procedure (a small flexible tube that is inserted     into the participants mouth to the participants stomach and into the participants liver to     visualize the bile duct) that is usually performed in patients for the following purposes :        1. The removal of all stones from the participants bile duct (if present).        2. Acquiring a tissue sample biopsy from any common bile mass to examine (if present).        3. Acquiring tissue sample biopsy from common bile duct narrowing (if present). However          this procedure is associated with an increase risk of infection compared with the          standard ERCP (ERCP without cholangioscopy). Previous studies have shown that despite          the administration of antibiotics prior to these procedures, infection still occurs.          This leads to a suspicion that other factors may be the cause in these infections.          Factors such as age, race, gender and ethnicity have not been fully explored yet. This          study aims to examine these factors in addition to others in patients who are undergoing          ERCP with cholangioscopy as part of their routine medical care. This examination will          allow us to bring out if any of the above mentioned factors may be involved in the          development of an infection after ERCP with cholangioscopy.   "
56666|NCT02543944|"     Overall, this proposal seeks to improve treatment strategies for the significant public     health problem of prescription opioid dependence by determining whether gabapentin, a     non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy, will     be effective in ameliorating withdrawal symptoms, craving and illicit drug use in     prescription opioid dependent participants undergoing a 10-day detoxification from     buprenorphine. In addition, the acceptability and feasibility of transitioning to depot     naltrexone therapy will also be determined. If successful, this study would provide data to     support further development of gabapentin as a pharmacological tool for improved outcomes     during opioid detoxification as well as an integrated outpatient approach for treating     prescription opioid dependence.   "
56667|NCT02543931|"     The purpose of this study is to find out whether turmeric dietary supplements that are     available over the counter for general use in the United States are safe and useful when     taken specifically for the treatment of rheumatoid arthritis (RA) and how the active     principles in turmeric are broken down and metabolized by the body in individuals with RA.   "
56760|NCT02542696|"     A 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD     patients with motor fluctuations (OFF episodes), designed to evaluate the long-term safety,     tolerability and efficacy of APL-130277.   "
56669|NCT02543905|"     Prostate cancer is the most common cancer in men in the United Kingdom (UK) with over 40,000     men diagnosed each year. Prostate cancer (PrCa) can run in some families and research studies     have identified several genetic changes that are thought to increase the risk of developing     prostate cancer. This study aims to look at the potential risk of these changes in targeted     screening. Some of these changes may cause a very slight increase in prostate cancer risk     while others may cause a much larger increase in risk of developing prostate cancer. The     investigators will invite men with a family history of prostate cancer for targeted prostate     screening (Prostate Specific Antigen (PSA) testing and a biopsy of the prostate gland) and     genetic profiling. This research will help us to determine what the risk of cancer is for men     who have inherited these genetic changes and also increase our knowledge about the role of     genetics in developing prostate cancer targeted screening. Some of these changes may cause a     very slight increase in prostate cancer risk while others may cause a much larger increase in     risk of developing prostate cancer.      The investigators will invite men with a family history of prostate cancer for targeted     prostate screening (PSA testing and a biopsy of the prostate gland) and genetic profiling.     This research will help us to determine what the risk of cancer is for men who have inherited     these genetic changes and also increase our knowledge about the role of genetics in     developing prostate cancer.   "
88783|NCT02123966|"     This research study is evaluating the effectiveness of topical sirolimus combined with     topical steroid therapy, as a possible treatment for oral cGVHD.   "
56674|NCT02543840|"     This randomized program evaluation is undertaken in conjunction with the Department of     Veterans Affairs Office of Mental Health Operations and the Quality Enhancement Research     Initiative. It is designed to answer two related questions: (1) Can an evidence-based     implementation strategy using the CDC's Replicating Effective Programs plus External     Facilitation (REP-F)enhance the adoption of team-based care in VA General Mental Health     Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans'     health status, satisfaction, and perceptions of care? The model for team-based care is the     evidence-based Collaborative Chronic Care Model (CCM).      In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary     Program team (BHIP) initiative, the investigators have structured a randomized, controlled     program evaluation to answer these questions. Specifically, using a stepped wedge design the     investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1     of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait     with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures     will be collected in a repeated measures design at 6-month intervals, and analyzed with     general linear modeling.   "
56675|NCT02543827|"     The purpose of the study is to evaluate the efficacy and safety of a biological vaccine     (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo     group.   "
56676|NCT02543801|"     This study evaluates two routinely used drug combinations for periarticular injection     following total hip arthroplasty for pain control. One group will receive liposomal     bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive     ropivacaine, clonidine, epinephrine and ketorolac.   "
56677|NCT02543788|"     Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that     may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any     acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON and     P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage could be     secondary to retrograde atrophy of axons within plaques of demyelination or a primary     progressive degeneration of ganglion cells, but the underlying physiopathology has not been     fully questioned in the different profile types of CON.      In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON,     i.e. secondary to demyelination or primary degeneration, in patients complaining of     persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to     moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive     neuro-ophthalmological assessment including clinical examination, visual evoked potentials     (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT     (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve. In     these patients with mild to moderate CON, investigators aim at differentiating patients     showing predominant demyelination from those showing pure or predominant axonal degeneration.     Visual function assessment and degree of axonal degeneration will be compared and correlated     in the two types of underlying pathophysiology and in the group of control subject. In a     following longitudinal study, the patients will be re-assessed a year later in order to     evaluate the progression of CON in both profile types. Our hypothesis would be that visual     function and progression is worse in the degeneration group as compared to the demyelination     group. This study should help to find reliable measures of the pathophysiology of CON and     correlate it with the long-term visual prognostic of the disease.   "
56678|NCT02543775|"     The primary objective of this study is to determine the feasibility of detecting the sentinel     lymph node (SLN) in patients with early invasive cervical cancer using a combined     radioisotope and blue dye technique.      The investigators hypothesize that the sentinel lymph node (first node draining the     tumour/cervix) for early stage cervical cancer represents the status of the regional lymph     node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need     for complete pelvic lymphadenectomy.   "
56679|NCT02543762|"     To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted     biopsies   "
59866|NCT02501954|"     To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces     the rate of recurrence when compared to sandwich therapy.   "
56680|NCT02543749|"     The aim of this phase I/II trial is induction of anti leukemic T cell immunity in a clinical     situation of minimal residual disease. This might be a strategy to immunologically     eradicate the residual leukemia cells. Patients to be included are chronic phase bcr/abl+ CML     (chronic myeloid leukemia) patients in stable cytogenetic and/or molecular remission.      These patients can be included if they have:        1. not achieved a CMR (complete molecular response) or        2. achieved bcr/abl < 10% on qPCR (quantitative polymerase chain reaction) (=MCyR) (Major          cytogenic Response), but less than a CCyR (complete cytogenic Response).      Autologous DC (Dendritic cells), generated under GMP (Good manufacturing conditions)     conditions, are used as a vaccine. These DC constitutively express all putative tumor     antigens. In order to ensure sufficient presentation of distinct CML-related antigens,     particularly in good responders to TKIs, DC are additionally pulsed with peptides from     bcr/abl, WT-1 (Wilms Tumor Protein) and proteinase-3. Monitoring of T cell reactivity against     these peptides can then serve as surrogate marker for anti leukemic immunity induced by the     vaccine. Vaccination is performed with 10^7 DC i.d. (intra dermal) in weeks 1, 3, 5, 8, 11,     14, 17, 20, 23 and 26. KLH (keyhole limpet hemocyanin) is used as an adjuvant for vaccine     preparations in weeks 3, 5 and 8 (and 11).   "
56681|NCT02543736|"     Knee osteoarthritis (KOA) patients, have impairments in gait and balance. Accurate gait and     postural balance analysis is needed to detect this impairments. Nevertheless methodological     quality about the recording of gait and balance analysis in KOA patients is lacking in     literature.   "
56682|NCT02543723|"     Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to     traditional intravenous chemotherapy, and factors promoting this trend include increased     survival times requiring long-term therapy, acceptability among patients, convenience, and     cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients,     adherence to these medications vary. Suboptimal medication adherence leads to loss of     treatment efficacy, increased toxicity, and increased health care costs. Thus, it is critical     to develop and test interventions that effectively improve adherence to OCAs. Although the     medication adherence literature has been criticized for methodological issues, some     components of interventions have had promising results on adherence such as electronic     monitored adherence feedback, cognitive-education, nurse-based interventions, and     technology-based or telehealth strategies. The investigators propose to unify components of     these effective approaches in a novel way to assess the efficacy and feasibility of two     telehealth-based strategies (electronic medication-event monitoring with feedback and     tailored nurse coaching which includes cognitive-education) in an effort increase OCA     adherence among cancer patients who are at high-risk for non-adherence in rural eastern North     Carolina.   "
88784|NCT02123953|"     The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438     following multiple oral doses to healthy adult Japanese male participants   "
56684|NCT02543697|"     Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical     Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if     the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided,     the investigators offer the patient operation.   "
56685|NCT02543684|"     The aim of the current study was to compare the effects of three ready-to-eat mixed meals,     with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic     response in patients with Type 2 diabetes mellitus (T2DM).   "
56686|NCT02543671|"     The primary aim of the current study was to investigate whether the consumption of vitamin D3     enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum     25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in     what degree it can contribute as a potential food-based strategy for the prevention of     vitamin D deficiency. A secondary aim was also to investigate any potential effect of the     intervention in several quality of life (QoL) indices in the population of postmenopausal     women under study.   "
56687|NCT02543658|"     Acute pancreatitis with Intra-abdominal Hypertension have high mortality rate,     intra-abdominal pressure mainly because of intestinal paralysis which due to edema,     intestinal gas, fluid and other intestinal dysfunction.Neostigmine is an anti-cholinesterase     drugs, can enhance intestinal peristalsis, promote flatus, defecation. This study will     determine the efficacy of neostigmine in the treatment of acute pancreatitis with     Intra-abdominal Hypertension.   "
56688|NCT02543645|"     This is a study to determine the clinical benefit (how well the drug works), safety and     tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll     patients with a number of tumor types; Phase ll will enroll only patients with renal cell     carcinoma (RCC).   "
56689|NCT02543632|"     Prospective, multi-center, post-market, non-randomized, nested-control, observational study     of the CE marked CardioKinetix Parachute Implant System.   "
56690|NCT02543619|"     Forty healthy patients with including criteria who failed to infra alveolar nerve block     injection (without lip numbness) have been randomly divided into two groups on a random basis     and have received Gow-Gates or another inferior alveolar nerve block injection. Endodontic     access cavity preparation has been initiated after complete anesthesia. If patients felt any     pain during the steps of caries or dentin removal, Endodontic access cavity preparation or     canal working length determination, treatment has been stopped and their pain has been     measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain     ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.   "
56691|NCT02543606|"     Bioequivalence of Two Formulations of Esomeprazole 40mg   "
59452|NCT02507362|"     the purpose of this study is to compare the efficacy and safety of a new method of corneal     cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known     Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)   "
56692|NCT02543593|"     Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high     prevalence and important sexual, conjugal and psychological deleterious repercussions,     effective evidence-based interventions remain limited. For a high proportion of women,     significant pain persists despite the currently available treatments. Transcranial     direct-current stimulation (tDCS) was shown to be effective in various chronic pain     conditions. So far, only one case report study has shown significant pain reduction in women     with vulvodynia. The main goal of this randomized controlled trial is to evaluate the     efficacy of tDCS in women with PVD compared to sham tDCS. Forty women diagnosed with PVD, by     a gynecologist following a standardized protocol will be randomized to either active or sham     tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period. Outcome measures     will be collected at baseline, after treatment and at 3-month follow-up. The primary outcome     is pain during intercourse assessed with a numerical rating scale (NRS). Secondary     measurements focus on sexual function, vestibular pain sensitivity, psychological distress,     treatment satisfaction and Patient Global Impression of Change (PGIC). The investigators     expect that active tDCS treatment will significantly reduce pain during intercourse     (post-treatment and 3-month follow-up compared to pre-treatment assessment). This trial will     provide important information for determining the efficacy of a novel and promising     intervention for women with PVD.   "
56693|NCT02543580|"     The purpose of this study is to evaluate the effects of single acupoint or two combination of     acupoints stimulated with electroacupuncture on patients undergoing radical operation of     breast cancer   "
56694|NCT02543567|"     The purpose of this study is to demonstrate the non‐inferiority of a heterologous prime‐boost     regimen using Ad26.ZEBOV as prime and MVA‐BN‐Filo as boost administered at different doses at     a 56‐day interval versus the same regimen with the recently released batches of Ad26.ZEBOV     and MVA‐BN‐Filo in terms of humoral immune response against the Ebola virus (EBOV) GP     (glycoprotein) as measured by enzyme‐linked immunosorbent assay (ELISA) at 21 days post     boost.   "
56695|NCT02543554|"     Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary     complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in     the emergency department (ED) has been studied infrequently when compared to the intensive     care unit; however, data suggests that ED-based mechanical ventilation has significant room     for improvement and may also be a causative factor in ARDS incidence.   "
56696|NCT02543541|"     The goal of this research study is to find out if providing patients who are enrolled in     phase 1 clinical trials with structured supportive care will enable them to continue in the     Phase 1 trial longer and improve their quality of life by reducing or treating side effects     and by providing emotional and social support to the patient and family. The structured     supportive or palliative care intervention will be provided by a team of trained specialists     which include doctors, nurses, social workers and spiritual care providers. The supportive     care team will provide treatment to address symptoms, such as pain or anxiety, caused by the     cancer itself or from the treatment. The team can make referrals to other specialists. Such     as psychologists or nutritionist, if needed, and can help arrange for services to address     home care needs.   "
56745|NCT02542891|"     To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural     Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU).     Within the French context the TAU is considered as the traditional face to face CBT.   "
56697|NCT02543528|"     This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group     clinical trial design. All subjects will participate in a 2-week daily disposable contact     lens adaptation period prior to being randomized into one of the four extended wear lenses.     The study has a total of 9 scheduled study visits and a total duration of ~197 days. The     lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.   "
56698|NCT02543515|"     Study type:      Observational, prospective.      Objectives:      Primary:      Identify psychosocial and clinical factors that predispose to the occurrence of pain     following office hysteroscopy      Secondary:      Stratify risk factors for pain previous Cesarean section and pain score repeat C section and     pain score post-menopausal and pain score type of delivery and pain score body mass index and     pain score history of dysmenorrhea and pain score, abnormal uterine bleeding and pain score     previous surgery upon uterine cervix and pain score Characterize women's psychosocial profile     and pain score Establish anxiety as a factor influencing pain perception using (State-Trait     Anxiety Inventory for Adults).      Determine if there is a specified population who would benefit from procedure under     anaesthesia   "
56699|NCT02543502|"     The main objective of this study is to evaluate the effect of treatment periodontal     endothelium-dependent artery of the arm in patients with acute myocardial infarction with     ST-segment elevation undergoing primary coronary intervention.   "
56700|NCT02543489|"     The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod     and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the     incidence of overhung with Flex IM rod.   "
56701|NCT02543476|"     This is a retrospective international, multi-center, non-interventional cohort study based on     use of data derived from established medical records and secondary analysis of archival tumor     samples. The study will collect data on patient and tumor characteristics, PD-L1 status,     patterns of treatment, and clinical outcomes, in up to 600 adult patients with     recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases     falling into specific ICD-10 or International Classification of Diseases, Ninth Revision     (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor.      For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as     the index date. The patient selection period extends from the 1st March 2011 to the 30th June     2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years     age, and ensures approximately 10 months follow-up for living patients recruited at last day     of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the     oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth),     oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the     study (Figure 1). Patients will be identified and followed up through their medical records     until death or end of data collection in approximately 20 centers in the US, Asia and Europe.      Patients' demographic, clinical characteristics, and medical history will be described.     Clinical outcomes including PFS, best response, duration of response, and ORR will be     described for the first line and second line of therapy (if any), and OS will be collected A     mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has     more than one suitable tissue sample, the most recent sample will be used as the mandatory     tissue sample. Where available, additional tumor samples obtained at any other time points of     the disease will be also collected (optional).      The enrolment target is up to 600 patients. Statistical analyses will be performed for the     whole cohort, per PD-L1 status and for predefined subgroups.   "
56702|NCT02543463|"     The purpose of this study is to compare the effect of the large head in THA with a navigation     system and without a navigation system.   "
60048|NCT02499588|"     The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin     over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as     part of their standard protocol of care following surgery.   "
56705|NCT02543424|"     Neurological pathologies cause important and permanent disabilities in every day life. These     pathologies can follow stoke, affecting two people per one thousand each year or cerebral     palsy, affecting two births per one thousand each year. To date, the diagnosis and the     rehabilitation of motor and cognitive problems has been carried out separately by different     domains. For example, physiotherapists have focused on motor problems and neuropsychologists     have focused on cognitive functions. However, a number of studies have demonstrated a link     between motor and cognitive abilities in adults and children. The present study has three     main aims: (1) to better evaluate motor and cognitive problems in brain damaged patients (all     ages), (2) to understand the link between motor and cognitive abilities in patients and     healthy participants and, (3) to propose new types of therapies based on the link between     motor and cognitive functions.   "
56706|NCT02543411|"     The primary purpose of this study is to investigate the effects of lidocaine on the total     administered dose of fentanyl during sedation for endoscopic mucosal resection.      The secondary purpose of this study is to investigate the effects of lidocaine on pain score     related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.   "
56707|NCT02543398|"     Following tooth extraction ridge preservation procedure have been suggested to limit bone     resorptive dimensional changes to facilitate prospective implant placement. While this is     particularly true for anterior teeth, no evidence is available to establish clinical     guidelines in posterior sites, i.e. following molar extraction.      This research project will answer the following question:      What are the dimensional changes of the hard and soft tissues encountered following molar     extractions with and without ridge preservation?   "
56708|NCT02543385|"     This study investigates the effect of low dose S+ketamine compared to placebo on cumulative     morphine consumption at 24 hours in women undergoing open abdominal hysterectomy with     remifentanil-propofol target controlled infusion. It compares the adverse effect profile in     patients receiving S+ketamine as compared to those who did not. Participants are randomly     distributed in two groups of 45 patient's each.   "
56716|NCT02543281|"     The purpose of this study is to better understand how adaptive cardiac resynchronization     therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only the     left side of the heart, rather than to both sides, depending on how it senses the heart is     functioning. CRT without the adaptive algorithm works by giving stimulation to both sides of     the heart. aCRT has already been approved by the FDA and is being used in patients now, but     it is not clear which patients it should be used in compared to normal CRT. This study will     include patients who are already scheduled to get a CRT device. The investigators will then     randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the     investigators will assess the electrical activity of the patients' hearts. After this time,     the patient and their doctors will be able to decide if they would like to change the type     CRT they have been designated.   "
56717|NCT02543268|"     The purpose of this study is to compare the humoral immune response induced by 3 different     batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the     Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.   "
56709|NCT02543372|"     Background: Problem gambling is a public health concern with prevalence rates at 2 %. Problem     gambling also severely affects concerned significant others (CSOs). Several studies have     investigated the effects of individual treatments based on cognitive behavior therapy (CBT),     but there is a shortage in studies on the effect of involving CSOs in treatment. This study     aims to compare an intervention based on behavioral couples therapy (BCT) involving a CSO     with an individual CBT treatment to determine their relative efficacy. BCT has shown     promising results in working with substance abuse, but this is the first time it is used as     an intervention for problem gambling. Both interventions will be Internet-delivered and     participants will receive e-mail and telephone support.      Method/Design: A sample of at least 100 couples will be randomized to either the BCT     condition or the CBT condition. The participants will work through 10 modules over 12 weeks     in a secure online environment, and receive support via email and over telephone. Repeated     measures will be conducted weekly and at 3, 6 and 12 months follow-up. The primary outcome     measure is gambling behavior, defined as time spent and money lost on gambling, as measured     by timeline follow-back. Secondary outcomes include gambling related harm, alcohol     consumption, relationship satisfaction and mental health for the gambler as well as for the     CSO.      Hypotheses: The investigators hypothesize that a) BCT will yield greater reductions on     gambling measures than CBT, b) BCT will yield a lower drop-out rate compared to CBT, c) BCT     will be superior to CBT on increasing relationship satisfaction, d) relationship functioning     will mediate change in gambling behavior in the BCT group and e) reduction in gambling     behavior will mediate change in relationship functioning in the CBT group.   "
56710|NCT02543359|"     Evidence-based treatments (EBTs) are available for treating Disruptive Behavior Disorders (     DBDs) including Parent-Child Interaction Therapy (PCIT). Despite EBTs' potential to help     children and families, they have primarily remained in university settings. Recognized field     leaders have expressed concern over the discrepancy between treatment research and clinical     practice, and have indicated that EBT implementation is a priority. Little empirical evidence     exists regarding how effective commonly used training models are in changing clinician     behavior, achieving full implementation (e.g., increasing treatment fidelity, integrating     into service settings), and supporting positive client outcomes. This novel application will     evaluate the effectiveness of three training models (Learning Collaborative,     Train-the-Trainer, and Web-Supported Self-Study) to implement a well-established EBT in     real-world, community settings.      To accomplish this goal, the project will be guided by three specific aims:        1. to build knowledge about training outcomes,        2. to build knowledge about implementation outcomes, and        3. to understand the impact of training clinicians using LC, TTT, and SS models on key          client outcomes.      Seventy-two of 243 possible (30%) licensed psychiatric clinics across Pennsylvania will be     randomized to one of three training conditions:        1. Learning Collaborative (LC),        2. Train-the-Trainer (TTT), or        3. Web-Supported Self-Study (SS).      Data also will be collected on staff trained by clinicians in the TTT group given that the     intention of a TTT model is for participants of that group to return to their organization     and train others within the organization. The impact of training (clinician level) will be     evaluated at 4 time-points coinciding with the training schedule: baseline, 6, 12, and     24-months. Immediately after training begins, parent-child dyads (client level) will be     recruited from the caseloads of participating clinicians (N = 288). Client outcomes will be     assessed at four timepoints (pre-treatment, 3, 6, and 12-months). Implementation outcomes     (clinic level) will be assessed at baseline, 6, 12, and 24-months after training. This     proposal builds on an ongoing state-led initiative to implement, and ultimately sustain, PCIT     statewide. Lessons learned from this project will directly impact future EBT implementation     efforts in Pennsylvania and other states, helping to increase the use of EBTs in community     settings nationwide.   "
56711|NCT02543346|"     Allergen challenge facilities have been utilized for many years in clinical drug trials     studying onset of action, proof of concept, duration of action, and efficacy. Each facility     has somewhat different design characteristics and pollen dispersal technologies. Facilities     are located in disparate geographic areas and have populations of participants who are     sensitized to allergens unique to that area. Therefore, facilities have operated as single     sites with little effort to evaluate facility comparability or to attempt standardization     across facilities. The purpose of this study is to compare the two sites and assess whether     the sites are able to achieve similar symptom scores.   "
56712|NCT02543333|"     Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients     with acute asthma; an observational study in healthy participants and during patients'     clinical investigation of broncho-reversibility in the asthma groups.   "
56713|NCT02543320|"     The goal of this study is to learn how the brain processes pain and if using neurofeedback     training can help teach patients ways to modify their own brain waves to decrease the     perception of pain and improve quality of life.   "
60719|NCT02490800|"     First in human, open-label, sequential dose escalation and expansion study of oral BAL101553     in adult patients with advanced solid tumors and adult patients with recurrent or progressive     glioblastoma or high-grade glioma.   "
56714|NCT02543307|"     Objectives: This quasi-experimental pre-post-study investigated the effect of newly developed     Nurse-led Patient Pathways (NPP) designed to improve patients`, and health care     professionals` as well as institutional outcomes.      Intervention: In the IG patients were cared for under the three newly developed NPP. NPP are     characterized by four principles: evidence-based nursing, patient and family centered care,     comprehensive discharge planning beyond hospital discharge and nurses' responsibility for     patients` processes. The principles support and strengthen patient and family preferences as     well as formalize nursing activities, and therefore contribute to process transparency in     relation to other health care professionals.      Outcomes: Primary Outcomes were defined as quality of nursing care (nursing care index, NCI),     and patient satisfaction (patient satisfaction with nursing care quality, PSNCQ). Secondary     outcomes were defined as 1) nursing work environment (nursing work index revised, NWI-R; and     nursing workplace quality, NWQ), and 2) institutional-related costs (length of hospital stay,     LOS; nursing time and nursing costs). Additionally, nurses` and other health care     professionals` experiences of intervention translation will be explored.   "
56715|NCT02543294|"     The goal of this clinical trial is to learn if heart function remains normal after stopping     heart failure medication in patients who have received chemotherapy.   "
56718|NCT02543255|"     This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone     acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in     patients with high-risk prostate carcinoma. Half of the participants will receive treatment     with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will     receive only abiraterone acetate, prednisone, and leuprolide.   "
56746|NCT02542878|"     This study evaluate the effect of the a low back self-application of myofascial release using     a foam rolling on back muscles endurance measured by the Biering-Sorensen test.   "
56747|NCT02542865|"     This study will test the hypothesis that a fortified malt based food may improve immunity     outcomes in 7-10 year old school age children.   "
56719|NCT02543242|"     The rationale for the conduct of this study is that the Intone device (along with pelvic     physiotherapy) can be used to help females suffering from urinary stress incontinence by     using electrical stimulation and biofeedback during pelvic floor muscle training. This     investigation is important because it can aid in the greater acceptance and development of     non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The     study results will address if the Intone device is beneficial and promotes long-term     improvement in women that suffer from urinary incontinence.   "
56720|NCT02543229|"     The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK) and     pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months with     and without Lucentis™ in patients with wet age related macular degeneration (AMD). This study     will be conducted in two parts: Part 1 will comprise an open label, sequential dose     escalation and Part 2 a randomized dose expansion.      OPT-302 is a soluble form of VEGFR-3 comprising the extracellular domains 1-3 of human     vascular endothelial growth factor receptor (VEGFR)-3 and the Fc fragment of human IgG1. It     functions by binding and neutralizing the activity of vascular endothelial growth factor     (VEGF)-C and VEGF-D on endogenous VEGFR-2 and VEGFR-3.      VEGF-C and VEGF-D promote blood vessel development (angiogenesis) by binding and activating     VEGFR-2 and VEGFR-3. VEGF-C is also a potent inducer of vascular permeability or leakage.     Angiogenesis and vascular leakage are key hallmarks of wet AMD. Approved therapies for wet     AMD include Eylea™ and Lucentis™ which block the activity of VEGF-A, but not VEGF-C or VEGF-D     which are alternate members of the same family of molecules.      VEGF-C and VEGF-D can stimulate blood vessel growth and leakage through the same pathway as     VEGF-A (via VEGFR-2), as well as through pathways that are independent of VEGF-A (via     VEGFR-3). Published studies have also indicated that VEGF-C and VEGF-D play an important role     in mediating resistance to therapies that block VEGF-A such as Lucentis™ and Eylea™.      Combination therapy with OPT-302 an anti-VEGF-A agent provides a more complete blockade of     the VEGF family. This strategy targets functional redundancy in the VEGF pathway and     mechanisms of 'resistance' or sub-response to VEGF-A inhibition.   "
56721|NCT02543216|"     Interactions between genes and environment, are likely to be crucial in the development of     the common diseases such as type 2 diabetes. It was recently shown that FADS1 and FADS 2     genotypes are the strongest genes in a genome-wide analysis regulating serum fatty acid     profile.The aim of this study is to test if subjects with the CC and TT genotypes of the     FADS1 gene (rs174547) respond differentially to a diet supplemented with linoleic acid     (substrate for FADS). We hypothesize that subjects with the TT genotype with more active     desaturases will be more sensitive to dietary modification leading to more robust differences     in serum FA profile, tissue inflammation and serum lipids.   "
56722|NCT02543203|"     Essential oils (aromatic oils extracted from plant parts) are routinely used by the public     and are available on the market. Investigators are conducting this study because it is     unknown whether the essential oils formulations will be safe and effective for improving     quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and     sleep.      Children invited to participate in this study must be between 3-9 years of age and have been     diagnosed with Autism Spectrum Disorder. Approximately 34 children and their families will be     enrolled in the study.      Participants will try two different fragrant oils in a double-blind randomized order. Each     child will receive each treatment for 3 months, with a 1-month washout period in between     during which no oil is used.   "
78394|NCT02259777|"     Study to investigate the effect of food intake on the bioavailability of a fixed dose     combination of 80 mg telmisartan / 10 mg amlodipine following a high fat breakfast   "
56723|NCT02543190|"     Short-term post-operative complications after colon and rectal surgery present a known major     clinical and financial burden for patients and hospitals. Focused efforts to reduce     readmissions after colorectal surgery is one potentially high-yield and broad approach to     address this problem since post- operative complications are the strongest predictor of     readmissions. We focus on decreasing readmissions after ileostomy surgery by using a     previously published intervention that prevents dehydration in the outpatient setting and     decreases acute renal failure complications. We plan to introduce the SWIFT post op program     for ileostomy patients at one academic and two community hospitals which are part of a single     health care system, and to then randomize patients to usual care in the setting of this new     program versus an aggressive compliance surveillance and improvement strategy (CSIS) strategy     using study personnel. Our primary study outcome is all-cause 30-day readmission, and our     secondary outcomes include patient satisfaction (CAHPS scores) and a cost-benefit analysis.     We seek to create a partnership between colorectal surgeons, inpatient nurse managers and     wound ostomy continence nurses (WOCN) at the three sites, linking them with outpatient nurse     practitioners and physician's assistants at the respective colorectal surgery clinics who     facilitate care-transition after hospital discharge.   "
56724|NCT02543177|"     Aim of the study is the determination of the ideal timepoint for the treatment of patients     with acute Non-ST-segment Elevation Myocardial Infarction (NSTEMI) and an acute or chronic     kidney disease (CKD) with a GRACE score < 140. It should be determine if a prompt coronary     angiography or the protection of the kidneys from the used contrast agent is more important     for the outcome of the patients. Additionally it will be investigated if the ischemic     precondition can help to prevent heart damages.   "
56725|NCT02543164|"     Objective of the study is to investigate the influence of beta-glucan enriched barley flour     as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic     response will be measured as AUC of blood glucose after consumption of barley bread(s), and     compared with white bread.   "
56726|NCT02543151|"     The purpose of this study is to describe SpyGlass choledochoscopy in patients with post     orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal     changes after treatment stents.   "
56727|NCT02543138|"     Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy     process that is difficult for unskilled physicians, whereas the use of a traditional trocar     is relatively likely to damage internal organs. In this study, investigators developed a new     trocar and examined its usefulness.   "
56728|NCT02543125|"     To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV) in     preterms with respiratory disease syndrome(RDS) after extubation.   "
56730|NCT02543086|"     This is a single-center open label study conducted in multiple sequential cohorts using     Induced Blood Stage Malaria infection in healthy volunteers to characterize the effectiveness     of KAE609 against sexual and asexual blood stage forms of Plasmodium falciparum. This study     is divided in 2 parts (Part A and part B). A total of 8 healthy volunteers per cohort will be     enrolled. Based on the results of Part A, Part B will be undertaken to evaluate the effect of     KAE609 following pretreatment with Piperaquine on sexual stage/gametocytemia and its activity     as an inhibitor of onward transmission to mosquito vectors using experimental mosquito     feeding assays.   "
56731|NCT02543073|"     Interstitial lung disease (ILD） is the late pulmonary complications after allogeneic     hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality.     At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the     efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as     the treatment of ILD will be evaluated in the recipients of allo-HSCT.   "
56732|NCT02543060|"     This study will evaluate the sensitivity of an assay and its ability to split a marketed     stannous fluoride toothpaste versus a negative control.   "
56733|NCT02543047|"     Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical     Support for Vein Grafts Used in CABG Surgery.   "
56734|NCT02543034|"     This study is a randomized, controlled, multi-centre, open-label, phase IV study.      Total 81 patients will be enrolled in this study. Patients will be randomly assigned to     Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.   "
56735|NCT02543021|"     Patients with colitis require regular 'surveillance' colonoscopy as their risk of developing     colon cancer is at least 2.5 times that of the general population. However, cancer in colitis     develops as flat lesions called dysplasia, that can be easily missed at routine colonoscopy.     As a result NICE guidelines for colitis surveillance recommend the use of a technique called     chromoendoscopy (CE) in which a water-soluble blue dye is sprayed through the colonoscope to     coat and highlight the lining of the bowel, making dysplasia easier to see. Although CE is     accepted as best practice for surveillance it is time-consuming, technically difficult and     requires expertise to interpret the appearances. For these reasons, its use is not widespread     and the vast majority of patients still receive the inferior 'routine' colonoscopy without     CE.      New technology means that the video image obtained during colonoscopy can be digitally     enhanced and coloured at the press of a button - termed virtual chromoendoscopy (VCE). This     could make surveillance colonoscopy shorter, more comfortable and cleaner (resulting in a     more 'dignified' experience) as well as cheaper and less technically difficult.      The main objectives to be explored in this feasibility study (and the larger trial) were     informed by a PPI meeting, which placed the ability to detect dysplasia at equal importance     with the participant's experience of the procedure in terms of speed, comfort and dignity.      This is primarily a feasibility study to assess patient experience, recruitment and retention     rates to the investigators' specified trial design, to support the development of a larger     crossover trial to compare VCE to CE during surveillance colonoscopy for colitis.   "
56736|NCT02543008|"     Comparison of the effects of physical activity (treadmill running) plus thoracic     mobilization, physical activity only or a placebo intervention (only manual contact thoracic     mobilization), on heart rate variability and pressure pain threshold.   "
78395|NCT02259764|"     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL   "
56737|NCT02542995|"     The health of the public depends upon smoothly functioning physician offices that promote the     health of both workers and their patients. This study targets ambulatory health care offices     with rapid paced, chaotic environments. Investigators will measure adverse outcomes for     providers and staff (e.g., stress and burnout), the impact these have on quality of care for     hypertensive, diabetic and depressed patients, and identify areas where practice redesign to     create healthy workplaces improves these outcomes.   "
56738|NCT02542982|"     This study investigated the combined effects of anodal tDCS and intensive motor training (MT)     vs. sham stimulation with MT (control intervention) on grip strength, motor performance and     functional use of the affected arm in population of chronic stroke patients.   "
56739|NCT02542969|"     The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of     rosuvastatin and/or simvastatin in healthy male subjects and female subjects not of     child-bearing potential.   "
56740|NCT02542956|"     The purpose of this study is to identify the best pain management for patients undergoing     abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM)     flap for breast reconstruction. The investigator is conducting this study to compare the     effectiveness of a continuous infusion pain pump versus a locally injectable long-acting     anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for     post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug     Administration) for the purpose of pain control after surgery, and have been used for this     purpose before.   "
56741|NCT02542943|"     This study will investigate the longitudinal efficacy of two experimental oral rinses     containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH     4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a     placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride     toothpaste.   "
56742|NCT02542930|"     Patients with Non-small cell lung cancer that had metastatic lesions after been treated with     definitive surgery or chemoradiotherapy are being asked to participate in this study.        1. To observe immunity-mediated tumor response outside the radiation field (abscopal          effect) after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung          cancer patients.        2. To induce the efficacy (effectiveness) of a new combination of therapy,          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic Non-small cell lung          cancer patients;        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.      This study will help find out what abscopal effects (good or bad) the combination of     radiotherapy and thymalfasin has on metastatic Non-small cell lung cancer.   "
56743|NCT02542917|"     This trial will test, in a representative group of IBD patients, the acceptability of - and     adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of     inflammatory bowel disease (IBD)).   "
56748|NCT02542852|"     Research ipotesis is to assess the efficacy and safety of a nucleos(t)ide sparing regimen of     atazanavir/ritonavir 300 mg /100 mg QD + Dolutegravir 50 mg QD for the management of     virological failure in HIV-1 infected patients.      The Primary Objective is to explore the 24-week efficacy of a nucleos(t)ide sparing regimen     of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of     virologic failure in HIV-1 infected, integrase inhibitor-naïve subjects.   "
56749|NCT02542839|"     Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently     reported as a source of disability, decreased quality of life, and social stigma. Botulinum     toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from     BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure     symptomatic benefits and does not seem to modify the disease pathophysiology.      The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as     an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD.     The primary goal of this study is to compare standard treatment with BoNT versus BoNT     combined with a two week course of rTMS.   "
56750|NCT02542826|"     This is a multi-site collaborative study that will be done in the context of three Quebec     hospitals' outpatient pulmonary rehabilitation programs: Montreal Chest Institute; University     of Laval, and Hopital Sacre-Coeur Montreal. The objectives are two-fold. First, to determine     the Minimal Clinical Important Difference in intensity ratings of perceived breathlessness     for each of the 3-min constant rate shuttle walking (3-MWT) and stair stepping (3-MST)     protocols in patients with chronic obstructive pulmonary disease (COPD). Second, to test the     hypothesis that both the 3-MWT and 3-MST protocols are able to detect statistically     significant and clinically-meaningful improvements in exertional breathlessness following an     7-12 week outpatient rehabilitative exercise training program in COPD.   "
56768|NCT02542592|"     The study evaluates the pathophysiological effects of a single dose Methylprednisolone     administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the     effect on immune signaling and recovery after surgery.      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will     receive placebo.      The investigators hypothesize that the group receiving Methylprednisolone will experience a     positive modulation of the immune response and an enhanced recovery.   "
56813|NCT02541994|"     Patients in for treatment of benign intracranial hypertension will undergo two tests that are     not routinely performed for these patients: central corneal thickness and axial length of the     eye. The data obtained from these measurements will be assessed to see if the correlate with     aspects of vision loss including visual acuity, visual field status, optical coherence     tomography (OCT) results, and fundus photographs.   "
56751|NCT02542813|"     Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum     haemorrhage (PPH). However, in resource-poor settings within the developing world, the     stability and therefore effectiveness of prophylactic IM oxytocin is diminished by a lack of     appropriate refrigeration facilities and availability of trained health care professionals     (HCPs) to administer IM injections. This study will be the first investigation of oxytocin in     humans via the inhaled (IH) route and is designed to evaluate the safety and tolerability of     inhaled oxytocin and the five non-pharmacologically active components in the placebo, and to     establish the PK characteristics of up to four fixed escalating doses of inhaled oxytocin. In     this single blind ascending dose-escalation study, the systemic exposure from up to four     proposed escalating inhaled fixed-dose levels (50 micrograms [mcg], 200 mcg, 400 mcg and 600     mcg) will be compared with the systemic exposure following 10 international units (IU) of IM     oxytocin in healthy premenopausal females.. A total of 15 subjects will be enrolled after     screening sufficient number of healthy female subjects and the subjects will be assigned to     one of the two treatment sequences. The total duration of this study is approximately 20     weeks.   "
56752|NCT02542800|"     Schemas describe mental structures storing recurrent and organized pattern of information.     Schemas may have a strong influence on the process of storing and retrieving new information     into memory. Previous approaches in the cognitive neuroscience of memory have entirely     focused on the individual dimension of preexisting schemas. In the real world though, much of     the researchers' experiences and knowledge are collective or shared. Such social-cultural     frameworks stored in collective memory may also reshape and reconfigure the construction of     individual memories. Attempting to ascertain the influence of collective schema on the neural     substrates of individual memories using cutting-edge brain imaging methods represents the     challenge that MULTIBRAIN2 seeks to tackle. To achieve this goal, the researchers will record     brain activity during MRI scanning sessions in a group of 24 participants while they are     performing an encoding followed by episodic memory retrieval tasks on pictures of the World     War II Memorial of Caen. This study will seek to identify brain areas of the prefrontal     cortex encoding the organization of knowledge in collective memory using multivariate     analyses of brain activity patterns, and then to understand how such regions might modulate     the recruitment of the hippocampus during episodic memory retrieval using analyses of     effective connectivity. The organization of knowledge in collective memory is measured in     parallel through 1) the analysis of French social memory of World War II using a corpus of     thousand of television and radio shows from the National Institute of Audiovisual, and 2) an     internet task measuring the organization of shared individual knowledge about World War II.     Once collected, these data will help us to understand how collective schemas may shape the     organization of individual memories.   "
56753|NCT02542787|"     Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.   "
56754|NCT02542774|"     To evaluate the risk of cardiovascular events associated with medication use for controlling     blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated     in primary care   "
56755|NCT02542761|"     The purpose of this study is to compare the functional performance of individuals with     transtibial amputation using two types of prosthetic foot designs: carbon fiber vs.     fiberglass composite.   "
56756|NCT02542748|"     Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be     used to treat hypotension but lead to lower fetal pH as well. This study is to compare the     effects of norepinephrine and ephedrine on hypotension in parturients.   "
88785|NCT02123940|"     Prospective, randomized clinical multicentric study in ICU during weaning from mechanical     ventilation.   "
56757|NCT02542735|"     Primary Objectives: To determine the incidence of type 2 diabetes in the south zone of the     di@bet.es study (Andalusia and the Canary Islands) at 6 years follow-up. To determine the     main risk factors associated with the incidence of type 2 diabetes and to check the role of     diet and physical inactivity. To determine whether the interaction between diet fatty acids     with the genetic variability of the fatty acid transport systems regulated by VEGFB influence     the risk of diabetes and related diseases. To test in a general population the predictive     value of some of the risk scores currently available: Finrisc, PREDIMED-clinical Score, etc..      Secondary Objectives: To determine the incidence of obesity and metabolic syndrome in the     south zone of the di@bet.es study. To determine the main risk factors associated with the     incidence of obesity and metabolic syndrome: to check the role of diet, physical inactivity     and certain polymorphisms in genes related to the handling of fatty acids Methodology:     Prospective population-based cohort study where the incidence of type 2 diabetes, obesity and     metabolic syndrome at 6 years follow-up will be determined in the sampling south zone of the     di@bet.es study (1600 subjects aged 18 years baseline data from a randomized cluster     sampling). Considering follow up losses in 25%, statistical power to detect as significant a     relative risk of 1.5 (incidence = 10/1000 person-years) is greater than 85% (alpha = 0.05).     Risk factor / exposure: alterations in glucose estimated from the baseline surveys, the     presence of insulin-resistance (HOMA) score Finrisk / PREDIMED-clinical Score / adherence to     Mediterranean diet transport and metabolism of fatty acids and genotypes of genes involved in     the handling of fatty acids. Covariates: all collected in the baseline study.   "
56758|NCT02542722|"     It will be selected 1274 subject older than 40 years of the population of Cabra in order to     realize a sociodemographic and habits (toxic, food, of physical activity) survey. It will be     realized a physical exploration including anthropometry, blood pressure, oral glucose     tolerance test, blood extractions (basal and after 120 ' of the OGTT). Several biochemical     determinations will be realized (p.e. marker of fat intake and marker of inflammation) The     proposed intervention consists of a series of clinical visits and phone calls programmed with     the aim to change the dietetic and physical activity habits of people. The Pizarra study     (financed with other grants and realised with the same methodology) will be use as cohort     control. Though the basic aim of the project is to achieve a reduction of the of diabetes     incidence with a hygienic - sanitary intervention, the ambition of knowing the major number     of possible factors that can participate in this process constitutes a complex project     capable of analyzing the problem from diverse points of view. Endocrinologists (of two     Andalusian hospitals), clinical biochemists, geneticists and dietitians they join in this     project to approach an integral way the etiopathogeny of the diabetes type 2.   "
56759|NCT02542709|"     The purpose of this trial is to study the effect of noninvasive brain stimulation in adults     with post-traumatic stress disorder.   "
56761|NCT02542683|"     1. Compare physical activity and cognitive functions between children having cardiac          surgery with an age-matched group of children undergoing non-cardiac surgery, as well as          otherwise healthy siblings or best buddies (or age and gender-matched children if no          siblings or best buddies available) before surgery and after surgery or six months          following initial assessment.        2. Determine the effects of a structured physical activity program for 6 months following          surgery on cognitive functions and adaptive behavior in children following congenital          cardiac surgery.        3. Determine the effects of a structured physical activity program for 12 months following          surgery on cognitive functions and adaptive behavior in children following congenital          cardiac surgery.        4. We will perform exploratory analysis to determine whether any effects of a 12-months          structured physical activity program on cognitive functions and adaptive behavior          persist beyond 12 months after cessation of the program.   "
56762|NCT02542670|"     Colorectal cancers (CRC) are the third most common human malignancy, and are also the leading     cause of cancer related deaths worldwide. Early detection of premalignant lesions such as     adenomatous polyps has decreased the risk of CRCs; however, cases which are initially     undetected and progress to advanced CRC with distant metastasis are still unfortunately     incurable. The development of CRC is a complex and heterogeneous process arising from an     interaction between multiple etiological factors, including genetic factors and environmental     factors such as diet and lifestyle. The challenges are to understand the molecular basis of     individual susceptibility to colorectal cancer and to determine factors that initiate the     development of the tumor, drive its progression, and determine its responsiveness or     resistance to antitumor agents. Next generation sequencing(NGS)-driven genomic studies are     already reporting novel features of cancer genomes beyond the traditional mutational     categories. Recent advance in sequencing technology has enabled comprehensive profiling of     genetic alterations in CRC.These methods are facilitating an increase in the efficiency and     resolution of detection of each of the principal types of somatic cancer genome alterations,     including nucleotide substitutions, small insertions and deletions, copy number alterations,     chromosomal rearrangements,DNA methylation sequencing such as bisulfite-sequencing and     microbial infections. Besides the microsatellite instability (MSI), some researchers reported     novel mitochondrial mutations in the cancer genomes. NGS technology will help the     investigators for understanding of entire CRC genomes and the obtained knowledge will lead to     a better diagnosis and personalized targeted therapeutics for CRC management   "
56763|NCT02542657|"     This phase I/II trial studies the side effects and best dose of clarithromycin when given     together with ixazomib citrate, pomalidomide, and dexamethasone and to see how well it works     in treating patients with multiple myeloma that has not responded to previous treatment.     Biological therapies, such as clarithromycin, pomalidomide, and dexamethasone, use substances     made from living organisms that may stimulate the immune system in different ways and stop     cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Giving clarithromycin with ixazomib citrate,     pomalidomide and dexamethasone may be a better treatment for patients with multiple myeloma.   "
56776|NCT02542488|"     This study evaluates the use of the STOPBANG questionnaire to predict whether an obese     pregnant woman has obstructive sleep apnoea. All participants will have a STOPBANG score     calculated and then be tested with overnight oximetry to see if they have obstructive sleep     apnoea.   "
88786|NCT02123927|"     The primary purpose of this study was to evaluate the single dose safety and pharmacokinetics     of TAK-438 in healthy Japanese men.   "
56764|NCT02542644|"     Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss     of endothelial cells, thickening of Descemet's membrane and deposition of extracellular     matrix in the form of guttae. This result in failure of the endothelium to support corneal     deturgescence leading to corneal edema. Affected patients complain about blurred vision at     early stages of the disease which can progress to blindness. The pathophysiology of the     disease is still unclear, but several studies point towards a genetic susceptibility.     Additional risk factors that have been identified are female sex, smoking and older age.      While for a long time penetrating keratoplasty (PKP) was the only therapy available for     affected patients, in the recent years less invasive methods such as descemet's membrane     endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane     and the endothelium is removed and replaced with the corresponding parts from a donor's     cornea. For FECD, this brings the advantage that only the diseased part of the cornea is     replaced. Graft detachment has been identified as the main complication following DMEK.      In the investigators' study, an ultra high resolution OCT system will be used to detect graft     detachment in patients with FECD after DMEK. With this technique, even small detachments can     be visualized. The area of graft detachment will be evaluated at predefined time points after     surgery and correlated to visual acuity. A follow-up of one year will be performed in order     to investigate the predictive value of graft adherence status at several time points for     visual outcome.   "
56765|NCT02542631|"     To compare glycemic control and treatment satisfaction using a novel bolus insulin patch     (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM     not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.   "
56766|NCT02542618|"     Background: Major depression is a common mental disorder with serious consequences. The     societal costs of depression are high. Despite the existence of empirically-supported     psychological therapies, many patients do not benefit from these treatments and relapse and     recurrence percentages are high. Improvement of existing treatments or development of new and     better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising     verbal therapy focusing on the inquiry of thoughts and could be a next step in improving     psychotherapy for depression.      Objective: The objective of the current study is to assess the effectiveness of IBSR.     Research to date has shown that IBSR is effective in reducing symptoms of anxiety and     depression. The investigators want to know if IBSR is more effective in reducing symptoms of     depression than the best psychotherapeutic treatment for depression at this moment, cognitive     behavioural therapy (CBT). The investigators' secondary objective is to know more about the     underlying mechanisms of change of these therapies.      Study design: A randomized controlled intervention study.      Study population: 88 patients with a mild to moderate depression as their principal     diagnosis.      Intervention: IBSR or CBT   "
56767|NCT02542605|"     Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to     Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced     Migraine-like Attacks in Migraine Patients.   "
62008|NCT02473939|"     The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and     pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated     doses in mild asthmatics (part 2).   "
56769|NCT02542579|"     Diagnostic tests for Helicobacter pylori infection consist of noninvasive tests (i.e., urea     breath test, serum antibody, stool antigen, urine antibody) and invasive tests (i.e.,     histology, Giemsa stain, Warthin-Starry stain, Gram stain, culture, rapid urease test).      Discrepancies between the tests may occur, and further induce problems for the diagnosis and     treatment for H. pylori infection.      Various types of microbiota can live together in a human stomach, and can be diagnosed using     16S ribosomal ribonucleic acid (rRNA) pyrosequencing analysis based on multiplex polymerase     chain reaction (PCR) method.      With the progress of gastric atrophy, the numbers of gastric microbiota may increase due to     the low acidity of the intragastric condition.      As a consequence, H. pylori are derived out the stomach, and may show a negative findings on     the H. pylori assays.      The aim of this study is to evaluate how the composition of gastric microbiota differ     according to the H. pylori test findings.   "
56770|NCT02542566|"     To test using a randomised control trial, whether conservative rehabilitation and protected     weight bearing versus early weight bearing and accelerated rehabilitation affects patient     outcomes post microfracture surgery of the knee.   "
56771|NCT02542553|"     The purpose of this study is to assess microbiologic concordance rates between right- and     left-lung bronchoalveolar lavage cultures from patients with suspected ventilator-associated     pneumonia, identify predictors of concordance, and evaluate the impact of discordant     microbiology on clinicians' ability to prescribe appropriate antibiotic treatments, the     investigators conducted a prospective observational study in the general intensive care unit     of a large university hospital.   "
56772|NCT02542540|"     Children with osteogenesis imperfecta are described as extremely sedentary and therefore     fatigable, which strongly impacts their daily activities. The physical rehabilitation of     these children is a fundamental aspect of treatment.      It has been shown that playing Wii console causes the same increase in energy expenditure     than practicing moderate exercise, while ensuring user safety. This type of physical exercise     with this type of fun game console might have a role in the treatment of OI children on the     physical side but also on the psychological side.   "
56773|NCT02542527|"     This study is an early (during the product development process) feasibility study. It shall     evaluate the device design concept with respect to device functionality of a new fluid filled     breast pump in a small number of subjects.   "
56774|NCT02542514|"     The study is an open label, prospective, multicenter, phase II study which aims to define     ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma     (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete     response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease     (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG)     criteria.   "
56775|NCT02542501|"     The intention of this study is to investigate how many patients with prostate cancer, planned     to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering     from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS     symptoms over time will be investigated.   "
56777|NCT02542475|"     To assess the effects of daily LFMS treatments for those suffering from affective or anxiety     symptoms. We hypothesize a reduction in affective and or anxiety symptoms after active     treatment over the period of one week, with improvement through the following week.   "
56778|NCT02542462|"     This is a prospective randomized clinical trial that aims to evaluate the potential effects     of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood     and stool cytokine responses. It will also assess the association between these outcomes and     the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be     randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with     other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with     other recommended vaccines. Data derived from the pilot study will be used to assess the     feasibility of conducting a larger scale study.   "
56779|NCT02542449|"     This study evaluates whether supplementations with a highly bioavailable green tea extract     may help obese women to counteract weight regain after a 3-month weight loss intervention.   "
56780|NCT02542436|"     This study will focus on participants in the United Kingdom (UK) to collect local data on the     effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal     cancer in normal clinical use.   "
56781|NCT02542423|"     According to literature data, Endocan can detect the onset of respiratory failure. The     investigators aim to prove its value also for cardiac surgery patients.   "
56782|NCT02542410|"     The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent,     cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of     endometriosis-associated pain in young women with endometriosis.   "
56783|NCT02542397|"     About half of all cancer patients seen in oncology clinics have pain at initial assessment;     pain relief within a one-month period is seen in approximately one third of these patients     and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain     include age older than 65 years, minority status, and inadequate pain assessment practices.     There is a need for better methods of opioid drug/dose selection and identification of risk     factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic     variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids.     Translating pharmacogenomic results into actionable prescribing decisions may ultimately     enable a personalized approach to pain management, increasing the chance of significant pain     improvement. Cancer outpatients with uncontrolled malignant pain will be offered a     pharmacogenomic test through participation in the study. The results of this test will be     used to modify their pain regimen, if applicable.   "
56784|NCT02542384|"     The study schedule is comprised of a 14-day Screening Period, a treatment period and an     observation period. All eligible subjects will be randomized into one of 3 treatment groups     (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously     prior to surgery, and at specific time intervals post surgery. Additional rescue pain and     anti-nausea medication will be made available. Post surgical changes in pain intensity,     nausea and vomiting will be assessed.   "
56785|NCT02542371|"     The purpose of this study is to measure arterial 99mTc-Tilmanocept uptake using single photon     emission computed tomography (SPECT/CT) scanning in HIV infected subjects known to have     subclinical coronary atherosclerosis as assessed by contrast-enhanced coronary computed     tomography angiography (CCTA).   "
56786|NCT02542345|"     This is a prospective, multicentric study conducted in order to evaluate if MRI     coronarography is as powerful as Cardiac Multislice CT in detection of coronary abnormalities     after coronary reimpantation in children over 5 yo, teenagers and young adults who underwent     coronary reimplantation in childhood.      Newborns suffering from transposition of the great vessels who underwent at neonatal age an     arterial switch operation (ASO) with coronary reimplantation, may develop in time with     growth, stenosis, twist or elongation of the reimplanted coronary artery, which may cause     myocardial ischemia. As well, aortic root surgery such as the Ross procedure and abnomalous     coronary artery from pulmonary artery (ACAPA) reimplantation may lead to the same     complications. Functional ischemic tests in a combination of three minimum are positive in     only 75% of the cases . Silent ischemia due to coronary abnormality is to be detected in     those patients.      In those patients, coronarography was recommended to be performed at least at 7 and 15 yo,     without any clinical symptoms . It has also been recommended to examine those patients at 5,     10 and 15 yo as growth is the main cause for coronary abnormality development. Cardiac CT has     been proven to be as efficient as coronarography to depict coronary reimplantation     abnormalities .      Due to the invasiveness of angiography and to the development of cardiac CT, in our     institution, the attitude is to performed cardiac CT instead of angiography with the same     frequency in our patients.      Coronaro MRI has been established as a valid technique for evaluation of coronary arteries in     patients after ASO .      The aim of this study is to evaluate if non contrast 3D MR coronarography is as powerful as     Cardiac Multislice CT for the depiction of coronary anomalies.      All patients, with prior ASO, Ross or ACAPA reimplantation, refereed for cardiac CT and     eligible for MRI, over 5yo are included in this prospective multi centric study.      Both examinations are performed on the same day after informed consent, from the patient or     from both parents if minor.      Cardiac CT is performed according to the usual protocol in our institution, and MR coronaro     angiography is performed as follow: excluding any contra indication to MR, the study requires     one or two maximum 3D true FISP sequence without IV contrast injection, with cardiac gating,     and free breathing.      3D images are evaluated blinded to the results of cardiac CT by two senior radiologists, with     at least 5 years of experience in MR and CT cardiac imaging.      Comparison of the results is consolidated afterwards. Other elements evaluated are tolerance     and feasibility of the examination.      The study is designed for four years and benefits from a grant from the Assistance     Publique-Hopitaux de Paris.   "
56787|NCT02542332|"     This study evaluates whether doctors are familiar with the statistical background of lung     cancer screening.   "
56788|NCT02542319|"     Randomized placebo-controlled double-blinded interventional trial to investigate the effect     of oral magnesium supplementation on vascular calcification in subjects with chronic kidney     disease. We hypothesize that oral magnesium supplementation will reduce vascular     calcification in subjects with chronic kidney disease while not decreasing bone mineral     density.   "
56789|NCT02542306|"     Bleeding is a common complication of cardiac surgery, especially aortic arch surgery     involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly     used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and     safety are unknown.      Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below     1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the     non-FC-treated group.   "
56790|NCT02542293|"     This is a randomized, open-label, multi-center, global, Phase III study to determine the     efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based     SoC chemotherapy in the first-line treatment of patients with epidermal growth factor     receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.   "
56791|NCT02542280|"     The investigator suggests that local endometrial injury using pipelle catheter performed in     the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy     rates among patients undergoing intrauterine insemination.   "
56793|NCT02542254|"     This study evaluates the addition of RPL554 to standard reliever medications for chronic     obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in a     randomised sequence:        1. salbutamol,        2. ipratropium,        3. salbutamol + RPL554,        4. ipratropium + RPL554,        5. RPL554        6. Placebo   "
56794|NCT02542241|"     The purpose of this study is to determine whether hypertonic saline solution is effective in     the resuscitation of traumatized patients undergone abdominal damage control surgery     regarding early closure of the abdominal wall.   "
56795|NCT02542228|"     This research is being done to construct a survey questionnaire, a quality of life tool, to     determine the health, well-being, ability to perform daily activities, and physical, social     and emotional functioning in participants with primary immunodeficiency disorders (PIDD).     This quality of life (QOL) tool will help physicians understand the effects of PIDD on a     person's health. These quality of life surveys are important tools for physicians to measure     outcomes for satisfaction and effects of treatment.   "
56796|NCT02542215|"     To evaluate the efficacy, safety, and pharmacokinetics (PK) of liquid cobiprostone in     preventing oral mucositis, when administered topically to the oral mucosa via spray for the     duration of radiation and chemotherapy (RT/CT).   "
56797|NCT02542202|"     This pilot clinical trial studies the side effects and best dose of stereotactic body     radiation therapy in treating patients with kidney cancer that has spread to other places in     the body (metastatic) or has come back (recurrent). Stereotactic radiosurgery, also known as     stereotactic body radiation therapy, is a specialized radiation therapy that delivers a     single, high dose of radiation directly to the tumor and may kill more tumor cells and cause     less damage to normal tissue.   "
56798|NCT02542189|"     The purpose of this study was to collect data on the prevalence and clinical significance of     elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation     presenting to an emergency department.   "
56799|NCT02542176|"     The purpose of this study is to evaluate the effects of both chronic and acute grape     ingestion in a population of men and women at higher risk for both type 2 diabetes and     cardiovascular disease (metabolic syndrome).   "
56800|NCT02542163|"     Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless     telemetry vest in cardiac rehabilitation.      Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating     the NimbleHeart chest harness system.   "
56802|NCT02542137|"     Patients with small cell lung cancer that had metastatic lesions after been treated with     definitive surgery or chemoradiotherapy are being asked to participate in this study.        1. To observe immunity-mediated tumor response outside the radiation field (abscopal          effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung          cancer patients.        2. To induce the efficacy (effectiveness) of a new combination of therapy,          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung          cancer patients;        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.      This study will help find out what abscopal effects (good or bad) the combination of     radiotherapy and thymalfasin has on metastatic small cell lung cancer.   "
56803|NCT02542124|"     In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor     efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose     TSEBT therapy. Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned     in this study, rather, a pre-defined starting dose will be explored; this dose is based on     two safety and tolerability studies of NM-IL-12 in healthy volunteers.   "
56804|NCT02542111|"     This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of     non-GCB DLBCL patients.   "
56805|NCT02542098|"     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness     of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring     around-the-clock opioid analgesics.   "
56806|NCT02542085|"     Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional     hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair     (laparoscopic mesh and fascial suturation).      Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka,     Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).      Patients are randomized to operative groups (lap. vs hybrid).      Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for     their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score     (VAS) are reported.      The primary end-points:        -  clinically and/or radiologically detected seroma in 1 month control        -  clinically and/or radiologically detected recurrent hernia in 1 year control      The secondary end-points:        -  peri-and postoperative outcomes/ complications, morbidity, mortality        -  duration of hospital stay        -  pain scale (VAS)        -  Quality of Life (SF/Rand36)   "
56807|NCT02542072|"     The purpose of this study is to compare the subjective performance of comfilcon A lens     against samfilcon A lens after 4 weeks of reusable lens wear.   "
56808|NCT02542059|"     In order to evaluate the difference in beta cell mass in patients with and without complete     resolution of type 2 diabetes mellitus (T2DM) after Roux en Y gastric bypass (RYGB)     investigators aim to compare quantitative PET imaging of the pancreas between these patient     groups.      These highly relevant data will provide investigators with more information on the possible     role of beta cell mass in the mechanisms behind resolution of T2DM after bariatric surgery.     This would be of great interest for the assessment of RYGB as an alternative therapy in     patients with T2DM with a BMI <35, who currently do not meet the international guidelines for     bariatric surgery.   "
56820|NCT02541903|"     Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease.     Supportive evidence for the value of systemic therapy does not exist for this disease and     there are no agents currently approved by regulatory agencies. This study will evaluate the     drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif     has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins     that are also found in PSCC. The drug has the potential for some patients to exhibit a     response contributing to a greater quality of life.   "
91259|NCT02091570|"     This study investigates nutrition bar consumption and possible impact on self-reported     ratings of hunger and fullness compared to a control.   "
56809|NCT02542046|"     Although positive oral contrast agents are used for the majority of abdominopelvic CT scans     in the United States, the quality of bowel opacification has not been compared between the     three major classes of positive oral contrast material (barium sulfate, ionic iodinated     contrast material, and non-ionic iodinate contrast material). This is a retrospective single     institution study of clinical records to show whether the uniformity of bowel opacification     is different between the three main types of positive CT oral contrast material used in the     United States (Barium sulfate, Diatrizoate, and Iohexol). The investigators will     retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and     iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality     of bowel lumen opacification by the positive oral contrast agents.   "
56810|NCT02542033|"     Primary objective of this study is to investigate the effect of sugar reduction (starting     from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by     comparing the reference food item apple juice (control) with the test product (apple juice     with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l     resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of     this study is to investigate the effect of sugar reduction on postprandial insulinemic     response.      Exploratory objectives are to investigate further characteristics of postprandial glucose and     insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.   "
56811|NCT02542020|"     Human immunodeficiency virus (HIV) infection is a major global health issue with up to 40     million people infected worldwide. Due to highly active antiretroviral therapy, mortality     related to acquired immunodeficiency syndrome (AIDS) has been reducing in the last decades.     However, liver disease remains as an important cause of severe complications and death.      Hepatic fibrosis progression is the main responsible for liver-related outcomes in     HIV-positive patients. Co-infection by hepatitis B (HBV) or hepatitis C virus (HCV) is highly     prevalence in HIV patients. Chronic viral co-infection induces faster liver fibrosis     progression compared to mono-infected HIV. However, published data have been reporting     presence of significant liver fibrosis in HIV without HBV or HCV infection. This might be     related to direct action of HIV in hepatocytes or association with others factors, such as     non-alcoholic fatty liver disease (NAFLD). NAFLD is associated with metabolic factors, such     as obesity and type-2 diabetes mellitus. However, antiretroviral drugs may induce abnormal     body fat distribution (lipodistrophy) and insulin resistance playing an important role on     this process. Liver biopsy has been historically considered as the gold standard to evaluate     liver injury. However, this painful method presents several limitations. Therefore, several     non-invasive methods for estimation of liver fibrosis, such as biomarkers (APRI, FIB-4,     FibroTest and FibroMeter) and transient elastography by Fibroscan, have been developed as an     alternative to liver biopsy. The diagnostic performance and prognostic value of biomarkers     and transient elastography have been validated in patients with chronic liver diseases.     However, few data are available in HIV patients, especially in those without chronic viral     co-infection.      Therefore, patients, medical doctors and scientific community will be beneficiated by the     future application of non-invasive methods for estimation of liver injury in clinical     practice in HIV patients.   "
56812|NCT02542007|"     To evaluate the safety, efficacy and deliverability of the Combo bio-engineered     sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the     treatment of patients with de novo stenotic lesions of native coronary artery.   "
56837|NCT02541682|"     In this study, the investigators aimed to research the relationship between affective     temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The     investigators aimed to assess temperament differences between healthy pregnant women and     pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.   "
56814|NCT02541981|"     The outcome of heart transplantation has improved by years. The renal dysfunction is a major     complication after heart transplantation.The natural course of renal function following     orthotopic heart transplant is not clear in Taiwan. A retrospective study was conducted on     patients who received a heart transplant at National Taiwan University Hospital between 1987     and 2015.   "
56815|NCT02541968|"     Randomized controlled non-inferiority trial comparing therapist-guided Internet-based     Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT     for Obsessive-Compulsive Disorder (OCD) in adults.      The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared     to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second     objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this     question has cost implications for the health system, a third objective is to carry out a     health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A     fourth objective is to explore whether ICBT is equally suited for clinic-referred cases     compared to self-referred patients. Finally, a fifth objective is to investigate whether     genetic markers, in combination with clinical variables, can be employed to predict treatment     outcomes with CBT in general.      Research Questions:      Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f)     CBT with regard to OCD symptoms, function and quality of life?      Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms,     function and quality of life?      Q3: Is ICBT a cost-effective treatment, compared to f2f CBT?      Q4: Is there a difference in treatment outcome between self-referred and clinical referred     patients?      Q5: Can clinical variables and genetic markers be useful to predict which patients will     benefit from CBT?   "
56816|NCT02541955|"     This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine     in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease     activity scores improve with Acthar treatment.   "
56817|NCT02541942|"     This study is conducted globally. This study describes pharmacogenetic testing of saliva     samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The     objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the     FVII gene in patients previously exposed to rFVIIa analogue.   "
56818|NCT02541929|"     Docosahexaenoic acid (DHA) is an essential omega-3 fish oil. DHA is critical to the structure     and function of brain cells.      DHA fish oil has been shown to be beneficial in cognition in several animal studies; however,     this effect in human studies is not clear. It is not known how much dietary fish oil can get     into the human brain. Thus, exploring fish oil delivery in human brains is critical for     designing appropriate interventions.   "
56819|NCT02541916|"     The purpose of this study is to validate and test a tolerance gene expression profile for the     identification of operationally tolerant liver transplant recipients, allowing for the     successful withdrawal of immunosuppression without rejection in these patients.   "
57693|NCT02530385|"     The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota     transplantation (FMT) transfers intestinal bacteria by a stool transplant from a healthy,     lean person to a person with obesity.   "
56821|NCT02541890|"     Aim is to study the effect of a work place intervention during a multicomponent     return-to-work rehabilitation program on return-to-work. The intervention is compared with     inpatient rehabilitation only, and participants will be recruited from the diagnostic groups     dominating the sick-leave statistics, namely musculoskeletal disorders, common mental     disorders (e.g. stress, depression and anxiety), and unspecific disorders including chronic     fatigue.   "
56822|NCT02541877|"     To observe the clinical outcomes of the different valve sizing strategies treating type-0     Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation     (TAVI) valve, compared with those of a standard sizing strategy of normal Tricuspid Aortic     Stenosis(TAS).   "
56823|NCT02541864|"     According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing     quadruple therapy was suggested to be the first choice for eradication therapy of     Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy     or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the     recommended first-line treatment is unknown. The investigators compared the efficacy of     14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line     treatment.   "
56824|NCT02541851|"     The acute pain remains unfortunately a major health problem in intensive care patients.     Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or     therapeutic procedure, could contribute to an increase in the incidence or in the intensity     of acute pain. The acute pain could impact on the prognosis of intensive care patients and on     the patients perception of the quality of care.      Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain     after intensive care admission could threaten the physical and psychological recovery after     the stay in the intensive care unit (ICU).      If many studies have been conducted to improve the management of the acute pain in the ICU,     only few data exist on the incidence and the risk factors of the chronic pain after a stay in     a surgical intensive care.      The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month     chronic pain after a stay in our surgical ICU.   "
56836|NCT02541695|"     Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already     suitable for dietary interventions in its current form, further characterization of the     working-mechanism of the attenuated strain and further optimization of the study design will     enable the investigators to better select those ingredients that affect the key     pathophysiological processes. The aim of the CORAL study is to further characterize and     increase the discriminative power of the diarrhoeagenic E. coli challenge model.   "
56838|NCT02541669|"     The purpose of this study is to assess the pharmacokinetics and safety of single- and     multiple-dose of TAK-491 in healthy Chinese participants.   "
78396|NCT02259751|"     Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483   "
56825|NCT02541838|"     Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system     impairments that accelerate age-associated limitations in functional independence and the     risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in     balance and mobility because of limitations metabolic abnormalities. The constellation of     impairments accompanying type 2 diabetes diminishes muscle function and performance including     strength and power. Loss of strength at higher speeds of movement (deficit in power) occurs     in neural activation of muscles, changes in muscle properties, and through in older     individuals with DPN compared to older controls. Consequently, this deficit in speed     dependent muscle power production leads to limitations in rapidly responding to sudden loss     of balance stability to prevent falling. The goal of this pilot research program is to     determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro     improving balance and mobility functions and preventing falls in older adults with DPN. The     investigators pan to use the results from this pilot study to design and implement a larger     randomized control trial.   "
56826|NCT02541825|"     This study evaluates the incidence of hepatic encephalopathy between covered stent of     diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of     the participants will receive stent of diameter of 7mm ,while the other half will receive     stent of diameter of 8mm.   "
56827|NCT02541812|"     The purpose of this study is two-fold: first, to observe the effect of one session of     repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of     patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second,     to observe the clinical effect of 10 sessions of rTMS in patients with OCD.   "
56828|NCT02541799|"     The investigators hypothesis is that patient comprehension of telemedicine-enabled research     informed consent is not inferior to standard face-to-face research informed consent.      The procotol will involve a prospective, randomized control trial to test the effectiveness     of a telemedicine medium in obtaining research informed consent. Within a single emergency     department, the investigators will conduct a simple, low risk randomized trial (single does     of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with     expected hospital admission). Prior to being approached for informed consent, potential     participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent     vs. consent provided by audio-visual telemedicine. After standard clinical care, potential     participants will be approached according to their allocation. Comprehension of research     informed consent will be the primary outcome, and will be measured using the modified Quality     of Informed Consent (QuIC) instrument.   "
56829|NCT02541786|"     Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed     release formulation. It is effective for symptom control of patients with gastroesophageal     reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear.     This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole     MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in     the treatment of H.pylori infection.   "
56864|NCT02541331|"     This study evaluate the efficacy of Mechanical Bacterial Lysate (PMBL - Ismigen®) to improve     the asthma control level (ACT score) as add-on treatment to routine asthma treatment in     children aged 6 to 16 with uncontrolled or partly controlled asthma. Half of the 150     participants will receive Ismigen® and their current asthma therapy while the other half will     receive Placebo and their current asthma treatment.   "
56830|NCT02541773|"     The purpose of this study is to understand the behaviour of certain blood markers in patients     with heart failure who undergo a cardiac device implantation procedure called cardiac     resynchronization therapy (CRT). CRT is an effective treatment for heart failure, but up to     30% of people do not respond and have poor outcomes (1,2). Despite extensive investigation,     identifying these patients continues to be a challenge. The study intends to describe the     changes in these blood markers before and after CRT and to examine any potential clinical     value.      The idea behind the study is that these blood markers alter in heart failure and change with     CRT implantation. Furthermore the pattern of marker expression before implant and after may     predict response and outcome.   "
56831|NCT02541760|"     Otitis media is one of the most common infections among children and is a complication in     about 30% of common colds. The most common complication of acute otitis media is otitis media     with effusion. Some studies have reported the effects of montelukast and mometasone nasal     spray in treatment of otitis media with effusion. However, current information is inadequate     in this issue. The aim of this study was to compare the effectiveness of montelukast and     mometasone nasal spray in treatment of otitis media with effusion in children attending     Koodakan hospital in Bandar Abbas, Iran.   "
56832|NCT02541747|"     This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and     staff during night shift.   "
56833|NCT02541734|"     The highly promising and innovative tracer on 111In-DTPA-AHX-Lys40-Exendin 4 has been applied     to determine beta cell mass in healthy volunteers and patients with type 1 diabetes. However,     the high retention of the tracer in the kidneys was leading to a kidney/pancreas uptake ratio     of 41±23. This high renal uptake is complicating absolute BCM quantification by SPECT     imaging. In order to reduce the kidney/pancreas uptake ratio, investigators propose a     co-infusion with the plasma expander Gelofusine since it has been shown in several     pre-clinical and clinical studies that Gelofusine can reduce the renal retention of several     other, closely related tracers. When investigators are able to reduce the kidney/pancreas     uptake ratio, these findings will improve the interpretation of clinical quantitative SPECT,     having important implications for therapeutic decision making for patients with diabetes,     insulinomas or congenital hyperinsulinism, and may also have a major impact on our     understanding of the pathophysiology of these diseases.   "
56834|NCT02541721|"     The current study aims to investigate the effectiveness in clinical symptomatic control and     tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar     dermatoses.   "
56835|NCT02541708|"     Intravenous iron preparations have been shown to be superior to oral iron and have largely     replaced the treatment of anaemia in Northern countries. However, the socio-economic and     medical conditions in low resource countries greatly differ from those in northern countries.     Patients' different access to medication supply, perception of medication need and compliance     as well as the burden of concomitant disease like malaria, soil-transmitted helminths,     schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness     and safety of iron substitution modality. The aim of the present study is to compare iv iron     substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low     resource country   "
56839|NCT02541656|"     A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid     administration can be directed by cardiac output monitoring which evaluate the response to     repeated fluid challenge or by preload dependence indices. These indices are not well     validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary     compliance.      The aim of the study is to study the validity of pulse pressure variation to predict fluid     response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on     the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic     waveform of pulse oximetry variation and the stroke volume variation.   "
56840|NCT02541643|"     To provide elotuzumab treatment for single-patient use.   "
56841|NCT02541630|"     A variety of mindfulness-based interventions, such as Mindfulness-Based Stress Reduction and     Mindfulness-Based Cognitive Therapy have been shown to be beneficial for individuals     experiencing mood and anxiety symptoms. The aim of this pilot study is to test the     feasibility of using a similar intervention, known as Big Mind, for veterans with PTSD and     other psychological symptoms.      Big Mind is a method of self-exploration that utilizes a voice dialog technique to help     individuals see the world and themselves from a variety of perspectives. The investigators     hypothesize that this process will increase mindfulness and decrease self-referential     thinking, which is associated with negative affect.      To test the feasibility of using this method, veterans with PTSD will complete a four-week     group Big Mind class with a total of four sessions. The investigators will use a single group     design with pre and post-intervention measures to assess tolerability and acceptance of the     intervention. Secondary outcome measures will evaluate symptom improvement and increased     mindfulness.      If this project demonstrates that using this intervention for veterans with PTSD is feasible,     then more rigorous clinical trials will be warranted.   "
56842|NCT02541617|"     Outcomes study to test the hypothesis that patients first identified by community-based     neurologists, implanted by a networked movement disorders center, and then managed by the     same community-based neurologist will have clinical outcomes comparable to movement disorders     centers.   "
56843|NCT02541604|"     This early phase, multicenter, open-label, single-arm study will evaluate the safety,     tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in     pediatric and young adult participants with solid tumors for which prior treatment was proven     to be ineffective.   "
56844|NCT02541591|"     The primary objective of the Neuroprotect trial is to assess whether or not a new goal     directed hemodynamic optimization strategy can reduce cerebral ischemia in post-cardiac     arrest (CA) patients.   "
56877|NCT02541149|"     This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel     diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha     fetoprotein the current marker ofhepatocellular carcinoma (HCC).   "
56914|NCT02540655|"     The purpose of the clinical trial is to study the therapeutic efficacy and safety of     Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized,     double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal®     through intravenous infusion.   "
56845|NCT02541578|"     Physiological complexity of gait, a measure of the interaction of multiple control mechanisms     for walking within a biological system, is decreased in persons with chronic stroke compared     to those without disability. Thus, it is assumed that the quantification of gait complexity     represents the adaptability and health of the individual. However, it is unknown if the level     of gait-related complexity improves over time with recovery from stroke. Therefore, the     primary purpose of this study is to determine if the physiological complexity of gait changes     over the first six months post stroke within the contemporary healthcare environment.     Secondary aims include 1) determining if there is a difference between the amount of     physiological complexity of gait and lateralization of hemispheric damage after stroke and 2)     exploring the relationship of complexity to lower extremity motor impairment, walking speed     and balance. Sixty individuals within one month post stroke from the greater Indianapolis     area will be recruited for this prospective, longitudinal outcomes study. Testing sessions     will occur at intervals across the first six months post stroke: within 1 month, at 3 months,     and at 6 months post stroke. During each testing session, participants will complete a     2-minute walking task during which accelerometer signals from wireless inertial measurement     units will be collected and converted to sample entropy to quantify the physiological     complexity of gait. Additionally, measures to quantify lower extremity motor impairment,     walking speed and balance will be collected and analyzed. Changes in complexity of gait from     early to later stages of stroke recovery may serve as a foundation for prognosticating     outcomes, such as predicting capacity for community mobility and/or risk of fall. The     proposed study will meet a critical need to develop methods that differentiate among     capacities for adapting movement patterns in individuals with neurological dysfunction. This     work will ultimately build upon evidence that will assist therapists in tailoring     interventions in such a way to optimize function.   "
56846|NCT02541565|"     This pilot clinical trial studies the side effects of pembrolizumab and combination     chemotherapy in treating patients with previously untreated diffuse large B-cell lymphoma or     grade 3b follicular lymphoma. Monoclonal antibodies, such as pembrolizumab and rituximab, may     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone,     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab     together with combination chemotherapy may be with a better treatment for diffuse large     B-cell lymphoma or follicular lymphoma.   "
56847|NCT02541552|"     Adductor canal block is commonly offered to provide pain relief following knee surgery with     the hope that they cause less leg weakness than traditionally performed femoral nerve block.     Infrequently, adductor canal blocks also result in leg weakness thereby potentially limiting     the advantages of the technique. Investigators want to find out the effective dose for a 30%     response (volume of local anesthetic which would result in clinically significant weakness of     the leg)   "
56848|NCT02541539|"     This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ)     in prevention of upper respiratory and gastrointestinal illnesses, which are found common     among adults in Malaysia aged from 18 to 81 years.   "
56849|NCT02541526|"     The purpose of this study is to evaluate tolerability, acceptability and potential efficacy     of 4 months of maintenance treatment with Mirtazapine as compared to placebo for patients     with co-occurring amphetamine-type stimulant and opioid dependence (COATS) receiving     buprenorphine maintenance treatment (BMT) in Kota Bharu.   "
56850|NCT02541513|"     The proposed study will evaluate the tolerability, acceptability and potential efficacy of     paliparidone for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS)     dependence. In the proposed clinical trial, all patients will first discontinue illicit     opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the     inpatient ward at the department of psychiatry before beginning to receive paliparidone.     Tolerability and acceptability will be evaluated by assessing the rates of patient retention     during treatment, patient satisfaction with treatment and adverse effects during treatment.     The potential efficacy of paliparidone will be evaluated with regard to the primary outcome     measure: reductions in illicit ATS use, based on urine toxicology testing and self-report.     Secondary outcome measures include treatment retention, reduction in HIV risk behaviors and     improvements in functional status.   "
56851|NCT02541500|"     The proposed study will evaluate the tolerability, acceptability and potential efficacy of     minocycline for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS)     dependence. In the proposed clinical trial, all patients will first discontinue illicit     opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the     inpatient ward at the department of psychiatry before beginning to receive minocycline.     Tolerability and acceptability will be evaluated by assessing the rates of patient retention     during treatment, patient satisfaction with treatment and adverse effects during treatment.     The potential efficacy of minocycline will be evaluated with regard to the primary outcome     measure: reductions in ATS use , based on urine toxicology testing and self-report. Secondary     outcome measures include retention, reduction in HIV risk behaviors and improvements in     functional status.   "
56852|NCT02541487|"     This is a cross-sectional comparison study of three maternal and fetal groups. Patients     studied are women (and their fetus if they conceive) participating in the Reproductive     Medicine Network's (RMN) FIT-PLESE investigation (funded, the NuPA and PAo arms) compared to     control mothers who decline the intervention protocols and their fetuses if they conceive.   "
56853|NCT02541474|"     There is an urgent need to develop new care models for patients with long-term and complex     needs. Our goal is services that are seamless, pro-active and person-oriented.      Intervention:      The Patient-centered health care team (PACT) is a service model for frail elderly patients     with multiple long term conditions. PACT is a seamless and proactive health service model     that aims to ensure safe early discharge and prevent hospital admissions for elderly frail     patients. The four pivotal elements are are supported by theoretical and empirical     underpinnings: 1) Goal-oriented person centered approach 2) Inter-disciplinary comprehensive     geriatric team: 3) Pro-active care plan.      Study Objective:      1) To investigate whether the PACT model improves health-related quality of life and patient     generated goals 2) carry out a health economic evaluation of PACT.      Design:      The evaluation model for complex interventions is our guiding evaluation framework. This is a     non-randomized, matched control, before after study. The intervention unit, is the care     organization, including four hospitals - municipality dyads. Two intervention dyads and two     control dyads. Index patients from intervention hospitals will be matched age, sex and number     of chronic conditions.      Intervention group: Patients with emergency admission to the UNN internal medicine department     in Tromsø and Harstad who are age > 65, have three or more long-term conditions, an emergency     admission within the last year, and an informed consent is given by patient or next of kin.     (Approved by ethics board 07.05.2015). The exclusion criteria are: Language barriers, and     less than 3 months life expectancy.      Controls: Recruited from the Nordlanssykehuset (Bodø) and UNN-Narvik internal medicine     departments, matched to the index patient's sex, age, number of long-term conditions. Control     patients will be subject to the same data-collection as intervention patients.      Data collections: All patient data will be collected at baseline, 6 and 12 months. Outcomes:     The primary outcome is the adjusted differences in the change of Quality of Life, measured by     Short Form-36 (SF-36), physical health dimension between intervention and control groups at 6     months after inclusion in study.   "
56889|NCT02540993|"     The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to     standard daily therapy, is effective and safe in treating patients with type 2 diabetes     mellitus and diabetic kidney disease, when compared to a placebo.   "
56854|NCT02541461|"     Nutritional status including changes of body composition is one of the most important     clinical determinants of outcome after gastrectomy for gastric cancer. The laparoscopic     gastrectomy is considered to be minimally invasive and to have favorable outcome that is     widely used in South Korea. It was reported that several advantages of laparoscopic     gastrectomy are the prevention of overt weight loss and enhanced recovery of muscle mass at 6     months after surgery. But there have been no longitudinal studies evaluating changes in the     body composition according to the different type of anastomosis of laparoscopic gastrectomy.      This study will therefore evaluate which of these two surgical procedures is most effective     for postoperative body composition in laparoscopic gastrectomy patients, by comparing whether     there are any differences in the amount of weight lost, lean body mass, fat mass, and lipid     profile. It will help to better define the influence of anastomosis on changes of body     composition after laparoscopic gastrectomy. This information can then be used by physicians     to better make a plan to the patient's body make up and medical comorbidities.   "
56855|NCT02541448|"     This study is designed to evaluate physician preference related to the use of the SURGIQUEST     AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of     pneumoperitoneum.   "
56856|NCT02541435|"     In Europe, breast cancer is by far the most common form of cancer diagnosed in women today,     accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is     usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and/or     trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast     cancer patients.      Unfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which     includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke,     and is the most common non-malignancy cause of death. During the last two decades, RT     regimens for breast cancer have changed and the doses of radiation to which the heart is     exposed are now potentially lower due to new and improved RT techniques. However, there are     no data on whether these new regimes decrease the risk of cardiovascular disease.      In this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and     15 years after both conventional and laser assisted breath controlled RT, and compared with     cardiovascular diseases in the general female population. A further aim is to evaluate signs     and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic resonance     imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac biomarkers and to     investigate whether these signs can predict later cardiovascular disease. The importance of     traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking     habits and physical activity, as registered before RT) will also be evaluated.   "
56857|NCT02541422|"     This will be a double-blinded study involving healthy non-alcoholic (self-reported)     volunteers over the age of 21 to consume beer on hospital property in a safe environment to     ensure immediate availability to medical attention and to security if needed. Volunteers will     be recruited from residency programs, hospital employees, emergency medical personnel, and     friends of study investigators. The volunteers will drink to a BAC of 0.1 as checked with a     breathalyzer. They will wear a tag around their neck with their study number, which will be     hole-punched with every beer consumed, which will be collected at the end of the night for an     accurate count of beers consumed per person. They however will not be forced to drink anymore     if they are uncomfortable with the amount of alcohol they are consuming and can withdraw from     the study at any time. All participants will be required to be driven home by a sober driver     once the participant's BAT is 0.02 or less. At the end of the night, the volunteer will be     breathalyzed to determine BAC, and given 1 capsule per 3 drinks consumed of either 600 mg     N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participate will fill out a     Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 - 4 point     Hangover Symptom Severity scale. A random number generator will be used to determine Placebo     or NAC first, then the participant will be given the other treatment at their subsequent     encounter. The study will be conducted over the series of many months, and data can be     analyzed by self-control comparing the participant's hangover symptom severity as determined     by the hangover symptom scale data when using NAC compared to placebo. The data will be     analyzed using the numerical values of each category for hangover classification and compare     the placebo data to the control data.   "
61103|NCT02485769|"     A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group,     Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And     Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects   "
56858|NCT02541409|"     The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24     weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited     setting. The investigators will compare treatment completion rates among 50 persons     chronically infected with HCV who will be randomized to receive either 1) 12 weeks of     sofosbuvir (SOF) + ribavirin (RBV) + pegylated interferon alfa-2a (PEG); or 2) 24 weeks of     SOF + RBV. Treatment will be delivered daily by field workers at a location of a participants     choosing. Secondary objectives are 1) To compare the efficacy of SOF+RBV with or without PEG     as measured by the proportion of subjects with sustained viral response at 12 weeks after     discontinuation of therapy (SVR12); 2) To evaluate the safety and tolerability of SOF+RBV     with or without PEG; 3) To assess the impact of SVR12 on insulin resistance.   "
56859|NCT02541396|"     To evaluate the safety and effectiveness of Wafermine administered with and without an opioid     medication for acute pain following bunionectomy surgery.   "
56860|NCT02541383|"     The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib,     Thalidomide and Dexamethasone will increase the stringent complete response rate after     consolidation therapy and increase the progression free survival after daratumumab     maintenance therapy in transplant eligible participants with previously untreated Multiple     Myeloma.   "
56861|NCT02541370|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous or donor-derived T cells may make the body build immune response to     kill cancer cells.      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in     treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.   "
56862|NCT02541357|"     This study aims to test the effects of a Preoperative Relaxation intervention and an     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in     Patients Undergoing colorectal surgery.   "
56863|NCT02541344|"     In this trial, the investigational product , the active ingredients which has been proven to     reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim     of this clinical study is to evaluate the possibility of the investigational product to     reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with     normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in     insulin levels.   "
56865|NCT02541318|"     Among health problems of peri-menopausal women, sleep disturbances is very common complaint.     The aim of this study is to realize the body constitution of the peri-menopausal women with     sleep disturbance; and to evaluate the effects of Duo-in practice on this population to see     if this intervention can decrease the dosage of hormone replacement therapy.      Quasi-experimental design and convenient sampling are both adopted. Participants will be     recruited from China Medical University, Tri-Service General Hospital, Taiwan Society of     Health Promotion, and Dr. Chen's Obstetrics and Gynecology Clinic. One hundred of     participants who are willing to try Duo-in exercise to improve their sleep quality will be     randomly assigned into experiment group and control group. The experiment group will practice     Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the     control group. Then, after 2 weeks, the participants of experiment and control group will     crossover. The experiment group has no intervention, but the control group will practice     Duo-in exercise for 2 months. Chinese version of the Pittsburgh Sleep Quality Index (CPSQI),     Body Constitution Questionnaire (BCQ), peri-menopausal disturbance scale, and peri-menopausal     fatigue scale will be used in the assessment at each time point. According to previous     experience, a total of 70 participants will completed the whole observation course.     Generalized estimating equations (GEE) is applied to analyzed the repeated measurement of     different time and groups.      This study will provide the evidence for Duo-in exercise as complementary treatment for     hormone replacement therapy for peri-menopausal women, and also for integration of Dao-in     exercise into mainstream treatment for other patients with sleep disturbance.   "
56866|NCT02541305|"     Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of     falls in institutionalized elderly.   "
56867|NCT02541292|"     Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy     with approximately 500 patients in Denmark. It is characterized by weakness and wasting of     the facial muscles, the muscles in the shoulder region and of the legs.      The primary aim of this study is to investigate possible links and order between inflammation     and fat infiltration in the muscles in patients with FSHD.      Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year     where the inflammation and fat infiltration in the muscles can be quantified.   "
56868|NCT02541279|"     The investigators determined the effectiveness of a group intervention for the treatment of     shoulder pathologies.   "
56869|NCT02541266|"     This research is aimed at finding out what may influence the decision of patients to     participate in trials involving imaging so that the investigators may improve our future     studies so they are more patient focused and acceptable in regards to scan schedules.   "
56870|NCT02541253|"     1. Part 1 If study subject and legal guardians who decide voluntarily to participate the          clinical trial, and sign the Informed Consent Form (In the case of study subject less          than 7 years of age, written informed consent by study subject's legal guardians), study          subjects eligible for participating this trial protocol were assigned to test group and          receiving the test drug 1 times or 2 times according to age.        2. Part 2 If study subject and legal guardians who decide voluntarily to participate the          clinical trial, and sign the Informed Consent Form(In the case of study subject less          than 7 years of age, written informed consent by study subject's legal guardians), the          study subjects eligible for participating this trial protocol were assigned to test          group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2          times according to age as below;             -  6 m ~ 3 years             -  3 years ~ 9 years             -  9 years ~ 19 years   "
56871|NCT02541240|"     Health professional students experience high levels of psychological stress. Individuals with     higher levels of resilience are better equipped to handle stress. The purpose of this study     is to evaluate the effects of an 8-hour resilience curriculum on stress levels, resilience,     coping, protective factors, and symptomatology on students enrolled in a doctor of physical     therapy (DPT) program.      Hypothesis: The curriculum will decrease stress levels, increase resilience, coping     flexibility, protective factors (optimism, positive affect, and social support), and reduce     symptomatology (negative affect, illness). Research on stress and its consequences     experienced by physical therapy students in particular is limited. If the results of this     study support this hypothesis, it may establish the benefit of adding a resilience component     to the curriculum for students of physical therapy.   "
56872|NCT02541227|"     Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine     treatment of patients with acute ischemic stroke.   "
56873|NCT02541201|"     This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial     that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Half of     the participants will consume of 1.5g of plant sterols daily as provided by two servings of     the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half     will consume placebo low-fat milk.   "
56874|NCT02541188|"     Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast     cancer in young women (< 40years old) is more aggressive in the Maghreb countries     comparatively to western countries. This aggressiveness could be associated with phenotypic     and genotypic differences between this two populations.   "
56875|NCT02541175|"     This study is designed to prove new methods to enable the automated analysis of esophageal     electrocardiography (eECG) signals in long-term measurements as well as the detection of     atrial fibrillation. The investigators hypothesis is that eECG signals allow the reliable     atrial and ventricular ECG signal distinction and the detection of atrial fibrillation.     Therefore 14 patients with arrhythmias and 6 cardiac healthy subjects are asked to take part     in this study. On each subject an esophageal ECG and a simultaneous standard surface ECG will     be taken for about half an hour. Patient undergoing a cardiac catheter ablation during their     current hospitalization will be further asked to allow access to the invasively obtained     measurements (i.e. atrial potential map) to further improve the understanding of the eECG     signals.   "
56876|NCT02541162|"     In a perspective of improvement of the global care of the patients, investigators wish to     estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a     clear, written and oral information, on the sexual satisfaction of the couples during     treatments.      Further to this study, the project will be to train and to sensitize the medical staff, or     still to develop new activities to meet the needs better of patients and of partners.   "
56878|NCT02541136|"     Stress-related disorders have a profound impact on public health. The World Health     Organisation (WHO) found major depressive disorder (MDD) to be one of the most important     human health problems with a prevalence of about 10%. In the current proposal the aim is to     investigate mechanisms of resilience against stress-related disorders and to examine changes     in quality of life, health, brain structure and brain function in individuals performing a     resilience programme. Therefore, the investigators will recruit forty healthy subjects from     the hospital staff exposed to normal day-to-day stress and not participating already in a     fitness programme. Half of the subjects will be randomised to a cognitive behavioural     self-experience and exercise programme for 20 weeks carried out by experienced supervisors,     coaches and trainers. Clinical psychological and psychiatric examinations will be carried out     weekly and a range of sophisticated neuroimaging techniques - high angular resolution     diffusion imaging (HARDI) and functional MRI (fMRI) - will be conducted before and after the     resilience program in order to investigate its effectiveness on brain structure and     function. The stress system will also be tested by examining cortisol awaking response (CAR)     and daily rhythms of cortisol secretion. These techniques are all well established in our     laboratories. The proposed research will likely stimulate the development of new prevention     strategies for this common and important disorder, and in the future could be applied to     other illnesses. Moreover, when successful it could be patented and offered for     implementation in the daily routine of median to large companies.   "
56879|NCT02541123|"     The primary objective of the clinical trial is to evaluate the effect of time on levels of     Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP)     biomarker levels in a population of head injured subjects over the age of 18 presenting     acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control     subjects.   "
56880|NCT02541110|"     Second trimester homocysteine & uterine artery doppler will be assessed& the cases will be     followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth     retardation) & other obstetric complications.   "
56881|NCT02541097|"     This study will establish factors fundamental to the improvement in communication and quality     of life for people with dementia known as primary progressive aphasia (PPA). PPA is a type of     dementia in which language declines but other cognitive skills (including memory) are     preserved in the first several years after the onset. This makes those in the initial stages     of PPA excellent candidates for treatment and creates a window of time (2-7 years) whereby     they can lead independent lives with minimal support. However, currently, no communication     therapy is available to people with PPA due to the progressive nature of the disorder and     lack of awareness of available options for professionals willing to treat it.      Participants with PPA in our study will receive two kinds of therapy for the words they     cannot recall spontaneously, and will be trained to maintain them through social interaction.     The type of training will be based on the most successful interventions the investigators     provided to people with PPA in our previous work. The investigators expect that successful     re-learning of forgotten words and practicing them in a group setting will facilitate     retention of communication skills leading to greater personal independence and     increased/maintained quality of life for people with PPA. Our study represents natural     combination of two novel approaches for PPA that ultimately will lead to lower demands on the     health care system.   "
56883|NCT02541071|"     Intrusive memories of traumatic events are core features of posttraumatic stress disorder     (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this     study was to determine whether the activity of the noradrenergic system during an     intrusion-inducing stressor influences subsequent intrusive memories.   "
56884|NCT02541058|"     This study is being conducted to develop and evaluate a cell-free fetal DNA test (Ariosa     Test) for non-invasive prenatal detection of 22q11.2 chromosomal deletion or duplication.     Investigators will be evaluating subjects with abnormal U/S.   "
56885|NCT02541045|"     The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients     with biopsy-proven non-alcoholic steatohepatitis.   "
56886|NCT02541032|"     The PREMIERS study is a proposal for conducting an adequately powered two center phase III     randomized controlled trial to test whether intensive periodontal treatment reduces the risk     of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the     resources in both states including established dental centers, Joint Commission Certified     Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate     Health Disparities. The proposal addresses specific issues with regards to recruitment of     African-American and rural stroke/TIA patients advocating the use of culturally appropriate     strategies to educate the study subjects regarding stroke, periodontal disease and the     periodontal stroke link.      The study proposes to utilize economic evaluation of the periodontal intervention from the     budgetary perspective. The focus will be on the financial sustainability of providing     aggressive periodontal therapy (with certain, although relatively low expenditures) in     exchange for a reduction of uncertain recurrent vascular events that may require high cost     emergency department utilization and/or inpatient care. The sustainability of the proposed     intervention after the completion of the project is integrally linked to the health economic     assessment to show the health care cost savings. By integration with a rural primary care     center, with an African American majority and households with average incomes below the state     average, the study ensures that the proposed intervention to reduce stroke disparity is     applicable to this target population.   "
56887|NCT02541019|"     Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still     frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the     main characterized prophylactic agents in patients at high risk, however there are few     studies comparing the efficacy of these drugs and no study that addresses women aged over 60     years.      In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing     laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic     induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis     of PONV.   "
56888|NCT02541006|"     The objective of this study is to compare the bronchodilator efficacy a of tiotropium     inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in     patients with moderate to severe chronic obstructive pulmonary disease (COPD).   "
56892|NCT02540941|"     The investigators will extract single cells and analyze the molecular composition of single     cells as well as bulks using the latest protocols for single cell and bulk genomics analyses     including genetic, epigenetic, transcriptomic and proteomic analyses using the latest     available protocols. A broad list of such example protocols are listed below.      The samples and their molecular characterization (including sequencing & molecular levels)     will serve as the basis for development of methods for single cells analysis. The developed     methods are aimed at genomic transcriptomic, epigenetic, or proteomics analysis of single     cells and share the same structure: the measured feature will be translated to a DNA library     which will represent the feature by a dedicated assay.      This library alongside with proper mathematical analysis of the sequencing results will be     performed in order to conclude the desired feature. The general structure of such protocols     is described in our review paper (Single-cell sequencing-based technologies will     revolutionize whole-organism science, E. Shapiro, T. Biezuner & S.Linnarsson, Nature Reviews     Genetics 14, 618-630, 2013) which is attached to our proposal.      In addition, the researchers will use sequencing based methods (existing and future     developed) in order to compare single cells and bulks from different tissues and/or different     time points from the same donor in order to measure genetic, epigenetic, transcriptomic, and     proteomic diversity.   "
56893|NCT02540928|"     The purpose of this study is to determine whether a drug called AMG 319 has an effect on a     patient's own immune response to head and neck cancer squamous cell carcinoma (HNSCC). This     study is specifically for patients who are having surgery to treat their HNSCC   "
56894|NCT02540915|"     The Chest Wall and Spine Deformity Registry is a tool designed to assist spine surgeons to     efficiently identify and track patients with chest wall and spinal disorders.   "
56895|NCT02540902|"     This will be a prospective single cohort investigation of the Columbus all polyethylene tibia     (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of     the project is to determine post-operative outcome of the all polyethylene tibia up to two     years.   "
56896|NCT02540889|"     The main aim is to develop and test the clinical efficacy of a novel, web based,     rehabilitation application. Listen-In will provide an effective speech comprehension training     tool that patients with aphasia can use to practice independently. This will free up     therapists time to provide additional assessment, supervision and functional intervention in     a highly cost effective manner.   "
56897|NCT02540876|"     This pilot phase I trial studies how well ilorasertib works in treating patients with     cyclin-dependent kinase inhibitor 2A (CDKN2A)-deficient solid cancers that have spread to     other places in the body and usually cannot be cured or controlled with treatment (advanced)     or have spread to other places in the body (metastatic) and cannot be removed by surgery.     Ilorasertib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
56898|NCT02540863|"     Objectives: The aim of this research is to compare the effectiveness of myofascial release     therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint     sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction     syndrome.      Material and Methods: A single-blind randomized clinical trial will be conducted in a     university research clinic. Sixty-four subjects with temporomandibular disorders and     myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group     (myofascial release protocol and Rocabado exercise therapy) and control group (exercise     therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and     joint sounds will be collected at baseline, and forty-eight hours after the intervention     phase.   "
56899|NCT02540850|"     The purpose of this study is to evaluate the performance of the SEPT9 gene methylation assay     in Colorectal cancer (CRC) high-risk population in Chinese hospitals using the opportunistic     screening method. The trial plans to evaluate a Chinese domestic SEPT9 assay kit produced by     BioChain (Beijing) Science and Technology Corporation, who is a close partner of Epigenomics     AG, the producer for Epi proColon 2.0 CE.   "
56900|NCT02540837|"     A higher number than expected of patients with hip fracture have only insufficient analgesic     effect of a femoral nerve block, which is the nerve block commonly used for this group of     patients. One of the possible causes of this failure to provide analgesia from a single nerve     block could be the that other nerves are involved in transmitting the pain signal. One of the     nerves that is believed to give off branches to the hip is the obturator nerve.      With ultrasound it is possible to make a selective proximal nerve block of the obturator     nerve.      The aim of this trial is to test the analgesic effect of a femoral nerve block i combination     with an obturator nerve block compared to femoral nerve block alone in a randomized and     placebo controlled design.   "
56901|NCT02540824|"     RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer     (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase     show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an     oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the     safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.   "
56902|NCT02540811|"     The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have     been implanted with the investigational product following a ruptured anterior cruciate     ligament (ACL) of the knee.   "
56903|NCT02540798|"     This study will look at how pre-test anxiety levels affect the reproducibility of symptoms     during routine urodynamic testing in women. Urodynamics is a test that assesses the function     of the lower urinary tract, including the bladder.   "
56904|NCT02540785|"     The aim is to evaluate the short-term changes in ocular surface measures and tear     inflammatory mediators after lenticule extraction (FLEx) and small-incision lenticule     extraction (SMILE) procedures.   "
56913|NCT02540668|"     The purpose of this study is to look at how much warfarin gets into the blood stream and how     long it takes the body to get rid of it when given both with and without lanabecestat.     Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots     when given with lanabecestat by measuring international normalized ratio (INR). INR measures     the time it takes for blood to clot and compares it to an average. Information about any side     effects that may occur will also be collected. The study will last about 5 weeks from the     first dose to follow-up for each participant.   "
56905|NCT02540772|"     Confabulators consistently generate false memories without intention to deceive and with     great feeling of rightness. However, there is currently no known effective treatment for     them. In order to fill this gap, the aim of this trial was to design a neuropsychological     treatment based on the current theoretical models and test it experimentally in two groups of     confabulators: experimental vs. control. The treatment consisted of some brief material that     patients had to learn and recall at both immediate and delayed moments. After both     recollections, patients were given feedback about their performance (errors and correct     responses). Pre-treatment and post-treatment baselines were administered. Confabulators in     the control group performed the baselines without treatment, and were then offered the     treatment after the second baseline.   "
56906|NCT02540759|"     The effect of various doses of Buglossoides oil on the accrual of eicosapentaenoic acid (EPA)     in blood and circulating cells will be investigated.   "
56907|NCT02540746|"     The aim of this pilot study is to examine a brief manualized treatment, Emotional Regulation     Group Skills Training (ERG ST), which has shown promise with high-risk youth presenting with     a range of mental health concerns. The investigators will examine the effectiveness of a ERG     ST group, as well as two additional components to which clients will be randomized: a     motivational enhancement (ME) pre-treatment, and family skills treatment (FAM). This project     will be the first to combine and test these modules as a transdiagnostic early intervention     for youth in the early stages on mental illness. This pilot trial will answer the following     questions: 1) What is the response rate to ERG ST compared to ERG ST plus FAM, and who     benefits? 2) What is the response rate to a ME pre-treatment, and who benefits? 3) What is     the acceptability of this treatment?      The ME pre-treatment will consist of four weekly one and a half hour sessions. The 12-week     ERG ST will consist of 12 weekly two-hour sessions with 4-12 youths per group. The 12-week     FAM will consist of 12 weekly two-hour sessions, with 16-20 caregivers per group. This study     will use a two-stage randomization design to allow for balanced groups if there is     differential attrition after pre-treatment. The following are the four treatment     combinations: ERG ST; ERG ST+FAM; ME+ERG ST; ME+ERG ST+FAM. Four subjects will be enrolled in     the study and randomized. The primary outcome is to improve emotion dysregulation in     participants. Emotion dysregulation will be measured using the Difficulties in Emotion     Regulation Scales (DERS).   "
56908|NCT02540733|"     Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction     (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis     compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown     that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar     with the findings in mice models. In this study, with multi-modal MRI technologies,     investigators tend to observe structural and functional changes of the brain in both DM and     non-DM CI patients and assess their neural rehabilitation using clinical scales in the     following 6 months. Investigators also expect to find out dynamic changes of brain structure     and function, to reveal the weights of factors including brain blood vessels, nerves and     function remodeling related with stroke recovery, as well as the potential mechanism in CI     patients with DM.   "
56909|NCT02540720|"     This study is performed to evaluate the efficacy and safety of various measures in the     treatment of severe HSP in children.   "
79381|NCT02246842|"     The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's     D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.   "
56910|NCT02540707|"     Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female     population. Antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic     distress. However, there is no such research for the new drug- mirabegron (a β3-agonist).     Thus, the aim of our study is to analyze the between-group differences in heart rate     variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic     distress, personality trait, family support and clinical outcomes between the mirabegron and     the solifenacin groups.      Patients and Methods: The investigators will perform a prospective randomized controlled     study to recruit 150 female OAB patients at the outpatient clinic of Department of Obstetrics     and Gynecology of National Taiwan University Hospital. All OAB female patients will be asked     to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires,     King's Health questionnaires, UDI-6 & IIQ-7, Patient Health Questionnaire, brief symptom     rating scale (BSRS), Maudsley personality inventory (MPI) and adaptability, partnership,     growth, affection, and resolve (APGAR) questionnaires, Sleep and Dietary habit Questionnaire,     standard 12-leads electrocardiography (ECG), 5 minutes Holter monitoring, cardio-ankle     vascular index (CAVI) test, bladder diary, 20-min pad test, urodynamic studies and     measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron     versus solifenacin treatment. STATA software is used for statistical analyses.      Possible Results: The investigators can answer that the between-group differences in heart     rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic     distress, personality trait, family support and clinical outcomes between the mirabegron and     the solifenacin groups. The above conclusions should be important for pre-treatment     consultation.   "
56911|NCT02540694|"     Rationale:      Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose     sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is     indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal)     for mediastinal nodal sampling is under discussion.      Secondly, which needle size or type provides optimal tissue sample quality for granuloma     detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue     acquisition of small core biopsies in addition to cytological aspirates.      Hypotheses:        1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14%          higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal          sampling in patients with suspected sarcoidosis stage I/II.        2. 25G ProCore needles provide superior sample quality compared to conventional 22G needles          in patients with suspected sarcoidosis stage I/II.      Study design:      Investigator initiated, randomized clinical trial. Setting: International, multicenter     (university and general hospitals)      Study population:      Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II     and an indication for tissue verification of non-caseating granulomas are eligible for     inclusion.      Intervention:      EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.      Main study endpoints:        1. The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic          lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in          patients with suspected sarcoidosis stage I/II.        2. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected          sarcoidosis stage I/II.   "
56912|NCT02540681|"     The aims of this study address an exploratory endpoint in the Major Extremity Trauma Research     Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that is     investigating prosthesis fit, alignment and condition of the residual limb. As there are no     validated measures of fit and alignment (factors known to impact comfort, function and     performance among amputees) the TAOS study includes a provision in the protocol for     acquisition of photographs, video and radiographs in order to help develop uniform     assessments of the residual limb. The goal of the ProFit study is to validate and refine the     prosthetic assessment tool (ProFit) that was developed by an expert panel of certified     orthotist prosthetistis (CPOs) in collaboration with orthopaedic trauma investigators, a     measurement scientist and a biomedical engineer from the BADER consortium.   "
56915|NCT02540642|"     Increased plasma homocysteine level is associated with macroangiopathy and nephropathy in     type 2 diabetes. Also increased levels of serum homocysteine are associated with     microalbuminuria which is associated with increased cardiovascular morbidity and mortality     among the patients with type 2 diabetes. With B12 supplementation homocysteine level can be     reduced .Type 2 diabetes as a metabolic syndrome may show improvement in glycaemic control     with Vitamin B12 therapy as there is correction of hyperhomocysteinemia. In studies it is     proved that combination of vit B12, folic acid and vit B6 are effective for     hyperhomocysteinemia.There are no such separate trials on the use of vit B12 alone. This     therapy may be used in large number of type 2 uncontrolled diabetic hyperhomocysteinemic     patients.      this study was planned with following objectives to study effect of Vitamin B12     supplementation on glycaemic control in poorly controlled hyperhomocysteinemic type 2     diabetic patients        1. Glycaemic control measured by levels of glycosylated haemoglobin (HbA1c) at baseline and          4 weeks        2. Fasting blood sugar level at baseline and 4 weeks        3. Serum homocysteine/ vitamin B12 levels at baseline and 4 weeks        4. Serum lipid profile at baseline and 4 weeks   "
56916|NCT02540629|"     This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by 2%     through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2)     multi-tiered response team CPR, and 3) feedback CPR.   "
56917|NCT02540616|"     The goal of this study is to determine whether external neuromodulation using transcranial     electrical stimulation (TES) can reduce the perception of self-motion that is experienced by     patients with MdDS. Mal de debarquement is translated as the sickness of disembarkment, and     refers to the chronic feeling of rocking dizziness that occurs after exposure to passive     motion. A similar form of rocking dizziness can be experienced without a motion trigger in     individuals with certain risk factors.      Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine     whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as     an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic     stimulation. The investigators will determine the optimal treatment duration and stimulation     parameters.   "
56918|NCT02540603|"     This investigation is designed to evaluate the performance (leak and comfort) as well as     participant's overall acceptance of the investigative full face mask amongst OSA     participants.   "
57386|NCT02534415|"     Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on     secondary wound healing of the free gingival graft donor site. The hypothesis of this study     is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free     gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.   "
56919|NCT02540590|"     Our overall goal is to characterize the role of the microcirculation in healing oral mucosa     after routinely applied surgery intervention in order to facilitate treatment. Using Laser     Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators     will have the possibility to detect functional alterations in gingival microcirculation in     case of wound healing. After periodontal surgery, by means of the detection of     microcirculation as a prognostic and diagnostic factor, the investigators can follow-up the     healing procedure and obtain data so as to design e.g. the incision line that takes     microvascular anatomy into account, thus result in better wound healing later on.   "
56920|NCT02540551|"     Recently the investigators have shown that the SN procedure performed through the injection     of tracers into the ovarian ligaments is feasible and promising in patients with clinical     early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the     identification of SNs in all 21 patients. Before a multicentre prospective trial can be     initiated, still some questions have to be answered, especially if a SN procedure still is     feasable in patients with OC through injection of the tracers in the ovarian ligaments, when     the ovarian tumour has already been resected, either during the same surgical procedure     (ovarian tumour resected for frozen section with a malignancy as result) or at a second     surgical procedure to complete the staging procedure (by laparotomy or laparoscopy).   "
56921|NCT02540538|"     The purpose of this study is to determine whether the HBAI20 vaccine is safe and more     immunogenic than the HBVaxPro-10µg in people who have never been vaccinated with a hepatitis     B vaccine and in people who have been vaccinated 6 times with hepatitis B vaccine but do not     have a protective anti hepatitis B antibody titer.   "
56922|NCT02540525|"     1. OBJECTIVE:           To determine the efficacy and safety of a single-incision mini-sling compared with a          transobturator midurethral sling for stress urinary incontinence (SUI) treatment.        2. METHODS:      This prospective single-center randomized controlled trial will involve 100 women with a     diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as     negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the     Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form,     operation time, complications, and reoperation rates were also recorded. The efficacy was     analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P     value >.05 rejects the noninferiority hypothesis of the mini-sling.   "
56923|NCT02540512|"     The purpose of the study is to test auricular (ear) acupuncture for the acute management of     patient pain in the Emergency Department as an alternative and adjunct to standard medical     treatment.      Currently, physicians who practice medicine here in the United States only have     pharmacological intervention at their disposal as the only available treatment tool they have     for the treatment and management of pain, and as a result, painkiller misuse, overdose, and     death has become the leading health epidemic in America. American healthcare is in desperate     need of alternative and safer ways to prevent prescription painkiller overdoses and to better     manage pain. If prescription painkiller dependencies can be avoided at the source,     potentially many lives and healthcare dollars can be saved. Acupuncture is an alternative     treatment that has been effectively used to treat pain for thousands of years in countries     around the world. The National Institutes of Health (NIH) and the United Nations World Health     Organization (WHO) have stated that acupuncture is a safe and effective treatment for the     management of pain. Supported by many studies illustrating seventy-five to ninety-nine     percent effectiveness in treating pain with an instantaneous drop in pain by twenty-five to     eighty percent, acupuncture appears to be the safest and most effective option available to     manage pain syndromes in the emergency department.      Auricular acupuncture has demonstrated beneficial effects to reduce acute and chronic pain     intensity. Specifically, for the thesis of this clinical trial, the investigators hypothesize     that auricular acupuncture can be an effective alternative and/or adjunct treatment tool in     the civilian emergency department for the acute management of pain.      In order to test the safety and efficacy of using auricular acupuncture in the emergency     department, people presenting to the emergency department with pain who are willing to     participate in the study will be randomized into three separate groups:        1. Standard medical group (tape on ear + standard medical drug)        2. Standard medical group plus auricular acupuncture (acupuncture + standard medical drug)        3. Auricular acupuncture group (acupuncture + placebo pill)      The design of these groups will allow the investigators to best test the efficacy of     auricular acupuncture versus the placebo effect and standard medical care as well as an     adjunct to standard medical care. To accomplish the objective of this proposal, the     investigators will pursue the following specific aims:      Specific Aim 1: To prove the efficacy of auricular acupuncture over a placebo group in the     management of pain syndromes. By having the acupuncture group and sham acupuncture group, the     investigators will be able to effectively compare the difference in pain levels with a     placebo-group.      Specific Aim 2: To prove that auricular acupuncture is an effective alternative and/or     adjunct to standard medical care in the Emergency Department.      By testing the efficacy of acupuncture in conjunction with standard medical treatment, the     investigators expect to see a potentiation of analgesic effects, and this will be noted by an     increased reduction in pain between the standard medical plus acupuncture group versus the     standard group and acupuncture group.      Specific Aim 3: To prove that auricular acupuncture as an effective pain management     alternative that decreases short-term prescription painkiller dependency.      Through a series of follow up questionnaires and a medication diary that the investigators     will give to the patient prior to discharge, the investigators will track the patient's need     and use of additional pain medications post treatment. These surveys will give a good     indication as to the effectiveness of auricular acupuncture to reduce a patient's dependency     on painkiller drugs in the short-term setting.   "
56932|NCT02540395|"     The main objective of the study is to demonstrate the utility and safety of the IFN-γ     (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification     of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The     enrichment study will test non-inferiority of low IS regimen compared to high IS regimen,     assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit     of maximum 10%.   "
56933|NCT02540382|"     Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in     transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal     hypertension.   "
56934|NCT02540369|"     To describe the use of intravitreal aflibercept in routine clinical practice and to describe     follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical     practice in Canada for a study population of treatment naive patients and those who have     received prior therapy (anti-VEGF injections, laser, steroids, etc).   "
57694|NCT02530372|"     The study will evaluate safety and effectiveness of the UriCap-F, a non-invasive urine     collection device for women, in hospitalized patients who would otherwise be treated with an     indwelling catheter, pads or diapers.   "
56924|NCT02540499|"     Despite considerable advances in cancer treatment, patients with locally advanced lung cancer     still face a poor chance of survival and a high risk of experiencing serious, life     threatening treatment-related side-effects. These side-effects are poorly understood and     difficult to measure: it is therefore challenging to design new treatment strategies aiming     to decrease treatment toxicity and yet increase survival. At present, many patients present     with tumours so large that only a low palliative dose of radiation therapy can be offered in     order to keep the risk of side-effects to an acceptable level. In this project, named INHALE,     the possibility of irradiating lung cancer patients while they hold their breath in deep     inspiration (so called: Deep inspiration breath hold, or DIBH) will be investigated. In DIBH,     the healthy lung tissue is pushed away from the tumour, and even when a large tumour is     present, a high curative dose of radiation therapy can be offered. This technique is simple     and is widely used to treat breast cancer patients in our institution as well as in other     centres in the world. If positive, results from INHALE can be transferred easily and with     minimal costs throughout Denmark and the rest of the world.      DIBH has only sporadically been used in lung cancer patients to date, because of the     assumption that this patient group, often having a poor performance status, could not comply     with DIBH procedure. However, the investigators' experience has shown that the majority of     lung cancer patients can comfortably hold short repeated DIBHs during treatment sessions     throughout the eight weeks of their treatment course, even if they have a relatively poor     lung function.      The differences in side-effects between patients treated with the INHALE regimen and a large     group of patients previously treated at our institution will be thoroughly investigated,     using both follow-up CT images and a range of clinical parameters. INHALE is a unique study     because of combining use of the highest level of technology to ensure high-quality treatment     in DIBH and a thorough scientific investigation of follow-up data. INHALE will provide an     improved understanding of how to assess and decrease treatment side-effects: consequently the     investigators aim to test the hypothesis in a large clinical trial in order to improve     survival of lung cancer patients.   "
56925|NCT02540486|"     Evaluating patients with type 2 diabetes either starting once daily basal insulin or     requiring increased basal titrations in order to compare the LTHome web based tool with the     usual standard of practice for insulin glargine dosing adjustment.   "
56926|NCT02540473|"     Physicians in general are at risk for burnout, and this risk is heightened among women,     particularly mothers. In a randomized design, central hypotheses in this study are that     mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention     will show significantly greater decreases in stress, depression, burnout, and associated risk     biomarker indices, as compared to comparison controls (who would meet in unstructured     gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that     the gains would be maintained three months after the intervention is completed.   "
56927|NCT02540460|"     The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371     after a multiple oral dose in healthy male subjects.      To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male     subjects.   "
56928|NCT02540447|"     The investigators tested the impact of purging the graft contents and mesenteric blood into     the systemic circulation versus washing out this volume out of the circulation in living     donor liver transplantation recipients.   "
56929|NCT02540434|"     The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce     allogeneic blood product use and decrease unnecessary laboratory costs. One of the NYPH     Quality and Patient Safety Goals for 2013 was to improve the appropriate use of transfusion     guidelines and reduce unnecessary red blood cell (RBC) transfusions. Further, this study will     help to answer whether RiaSTAP is a more effective product to treat bleeding than     cryoprecipitate. In addition, this trial will provide investigators with preliminary data to     apply for future federal funding opportunities, such as the National Heart Lung and Blood     Institute sponsored R21 grant (PAR-13-025) that encourages research grant applications from     investigators who propose to study research topics in blood banking and transfusion medicine     aimed at improving the safety and availability of the blood supply and the practice of     transfusion medicine. The investigators anticipate future follow-on studies further     investigating fibrinogen concentrate and other similar therapeutics in other perioperative     populations, such as in postpartum hemorrhage or surgical ICU settings. Finally, this study     involves the use of a safer therapeutic, fibrinogen concentrate, to improve patient care and     patient safety. This product does not require the time-intensive process of thawing;     therefore, delays in patient care can be avoided by having the product readily available in     the OR.   "
56930|NCT02540421|"     Objectives: To identify factors associated with disease recurrence in patients with     high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the     transformation zone (LLETZ).      Study Design: A case-control study that included 103 patients. Patients were included in the     study if they had a history of surgery for conization by LLETZ for the histopathological     diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III).     Follow-up exams were conducted every six months with Pap smear collection and colposcopic     examination with biopsy, when necessary, for a minimum period of twelve months. Cure was     defined as a normal follow-up examination within 24 months. During follow-up, relapse     occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at     which time a new cervical conization by LLETZ was performed.   "
56931|NCT02540408|"     A pilot study from the investigators group suggests that the prevalence of chronic     obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general     population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality     of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial     stiffness and exercise capacity) are largely unknown. Although immunization against organic     dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.      This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in     subjects without any occupational exposure (control arm) through a vast COPD detection     program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits,     dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic     inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and     patients with COPD without any occupational exposure; (iv) identifying etiological factors of     COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy     farmers with COPD and dairy farmers with normal pulmonary function tests); and (v)     constituting a cohort of COPD patients and control subjects for further longitudinal studies.      Data from selected patients (either current or former smokers) with mild COPD and from     matched controls will also be analyzed in an ancillary study which objectives are to compare     exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between     asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.   "
56969|NCT02539914|"     The purpose of this study is to determine whether it is feasible to use a virtual reality     task for stroke rehabilitation for training motor and cognitive (attention and memory)     domains based on the use of positive stimuli, and to evaluate the potential benefits in     comparison to standard rehabilitation.   "
56935|NCT02540356|"     The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy     given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after     intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated     dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with     refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma     pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will     be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability     of the RP2D and explore clinical signs of efficacy.   "
56936|NCT02540343|"     The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain Questionnaire     into German.   "
56937|NCT02540330|"     This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled     for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or     DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The     subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All     subjects will be monitored for systemic and local adverse events during the procedure, and     following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant     will undergo serial blood draws to determine fulvestrant blood concentration levels.   "
56938|NCT02540317|"     Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and     cause substantial suffering. Prior evidence suggest that these disorders may be effectively     treated with cognitive behavior therapy (CBT), but access to psychological treatment is     limited. One possible solution is to provide therapy via the Internet, which has been shown     to be effective for anxiety disorders and depression. In the present study, we will     investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout     syndrom in a randomized controlled trial (N=100). Participants will be randomized to active     treatment (n=50) or a control condition on waiting list.   "
56939|NCT02540304|"     This study is evaluating the effectiveness of three evidence-based teen pregnancy prevention     (TPP) programs in reducing sexual risk-taking behaviors of youth. The study is using an     experimental design in which youth are randomly assigned to receive either TPP programming or     services as usual.   "
56940|NCT02540291|"     This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and     tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the     recommended Phase 2 dose (RP2D) of E7046.   "
56941|NCT02540278|"     This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention     program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.   "
56942|NCT02540265|"     The primary objective of this study is to evaluate the safety of N1539 in subjects with acute     moderate to severe pain following unilateral bunionectomy.   "
57397|NCT02534272|"     D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The     study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to     changes of gut microbiota in subjects presenting with or without intestinal symptoms.   "
56943|NCT02540252|"     Patients with non-traumatic lower limb amputation are characterized by; high age; majority     being men; multimorbidity; and high mortality. The patients comorbidities are related to     diabetes and cardiovascular disorders such as arteriosclerosis.      Major surgery induces a surgical stress response that initiates a catabolic metabolism.     Furthermore, the risk of systemic inflammatory response syndrome (SIRS) both before and after     amputation is high (3) as the most prominent indication for amputation is gangrene, followed     by non-healing or infected wounds. This leads to an impaired immune response and an increased     insulin resistance that also includes a cascade of impaired appetite regulation, low dietary     intake and reduced nutrient uptake form the intestine which increases inflammation, loss of     muscle and risk of severe complications.      Among healthy adults with a normal weight a slow speed of eating will result in a low     nutritional intake due to faster satiety experience.      Low appetite following major surgery is related to the regulation of hormone controlling the     appetite. Especially older patients experience variations in appetite that affect their     eating pattern such as eating speed and intake. It is therefore reasonable to assume that the     speed of eating and the total nutritional intake among older patients, who are exposed to     catabolic metabolism, are associated.      The hypothesis is that major surgery induces a change in patients' current eating pattern     that is measurable and can be identified as a surrogate measurement of the catabolic state     that is related to inflammation.      Eating Patterns are often described in clinical practice without engaging in nutritional     assessment of the patient. Whether the speed of eating is an objective marker of the current     nutritional status has not been established.      This study investigates patients undergoing lower limb amputation and their nutritional     status, eating pattern and inflammation and whether this is linked to the current degree of     disease. The purpose is to describe the development in nutritional status before and after     amputation and to investigate associations between patients eating pattern and nutritional     status to inflammatory and metabolic biomarkers reflecting the degree of disease.   "
56944|NCT02540239|"     To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S)     for colonoscopy.   "
56945|NCT02540226|"     Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for     Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is     an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA     can be given either intravenously or topically (placed directly on the open wound) before     wound closure. Patients with certain medical conditions have been found to have a high risk     of thrombosis after being given intravenous TXA, which may lead to serious complications.     However, to date, no high-risk patients have been identified for use of topical TXA. This     study will look at thrombogenic markers (proteins found in blood that promote clot formation)     after TXA is given either intravenously or topically. If the effect on these markers is     similar between intravenous and topical use of TXA, then the safety of topical TXA should be     questioned. Of note, these markers have never been measured after TXA has been given     topically. As a result, this information would be important for the medical community.   "
56946|NCT02540213|"     This non-interventional, observational study investigates the efficiency, safety and     acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA)     using a self-application system. For each participant, the investigator documents 9 months of     treatment with Mircera with respect to efficacy, safety and acceptance.   "
56990|NCT02539615|"     The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for     the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology.     Including collecting, processing and shipping samples, training staff, processing samples,     sample interpretation and accurate and timely reporting in a manner resembling routine     clinical use. The study will include a subset of patients who are known carriers of a BRCA     germline mutation. NAF from this subset will be submitted for molecular testing in addition     to cytology.   "
56947|NCT02540200|"     Hip pain in young patients is difficult to diagnose and treat. However, with advanced imaging     techniques and surgical method, the investigators are able to identify hip cartilage lesions     as a cause for the hip pain. MR (magnetic resonance) arthrography is the best imaging     modality to diagnose chondral lesions of the hip, but it occasionally miss the pathology,     thus necessitating a more accurate and invasive means of diagnosis. Consequently, hip     arthroscopy is increasingly used for both diagnosis and treatment for hip cartilage     pathology.      Microfracture is a means of stimulating bone marrow, and is a standard treatment for small     chondral lesions. This procedure has shown to result in excellent functional and anatomical     outcomes. Microfracture is now recognized as a standard treatment for cartilage lesions in     the knee, and recently the indications of this technique extended to hip pathology.      The BST-CarGel device (Piramal Life Sciences, Bio-Orthopaedic Division) is based on the     patented technology for cartilage repair. BST-Gel comprised of the buffer     beta-glycerophosphate and chitosan, which is a well-studied natural material that is     biocompatible and appropriate for its use as a scaffold to assist in cartilage repair.     BST-Gel is mixed with the patient's whole blood and delivered to a surgically prepared     cartilage lesion in conjunction with bone marrow stimulation. The BST-CarGel/blood mixture     solidifies in the cartilage lesion and provides a three-dimensional scaffold for the repair     process. This product has shown to result in superior chondral lesion repair when compared to     the bone marrow stimulation alone.      The current study will collect data through standard of care practice when BST-CarGel in     conjunction with a bone marrow stimulation technique is used for the treatment of focal     cartilage lesions in the hip. In addition, these patients in the study group will be compared     with the group o patients who undergo the bone marrow stimulation technique alone. The     efficacy of BST-CarGel in conjunction with microfracture for cartilage lesions in the knee     has been shown in previous studies. Additional research is required to expand knowledge and     develop treatment guidelines for the treatment of the cartilage lesions in the hip using     BST-CarGel. As the BST-CarGel improves the results of the bone marrow stimulation techniques     without increasing the risks of the procedure, this device can be very beneficial in the case     of cartilage lesions in the hip.   "
56948|NCT02540187|"     Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic     mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible     for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a     factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX)     deficiency. According to the intensity of the defect, there are three forms of haemophilia:     severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor     (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic     manifestations are variable from one patient to the other. Moreover, several studies showed     that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that     haemophilic A patients.      The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin     system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive     inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation     starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the     VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the     amplification pathway being strongly altered because of factor VIII or IX deficiency,     thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We     can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI     that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.   "
56949|NCT02540174|"     This is a multicenter, interventional, randomized study among patients with a first lung or     head & neck cancer who are still active smokers ± alcohol misusers.The study will aim to     compare the systematic implementation of an addiction treatment program initiated at hospital     and integrated to the initial cancer treatment program (Arm A), versus the as-usual     procedure, which consists in recommendations to follow an addiction treatment program (Arm B)   "
56950|NCT02540161|"     The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture     that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose     tumor is EGFR amplified. This is a phase 2 study that will accrue a total of 61 patients with     WHO grade IV recurrent malignant glioma (glioblastoma or gliosarcoma) in two cohorts to     assess the efficacy of Sym004.   "
56951|NCT02540148|"     This randomized study will assess the effectiveness of externally applied micro current     electrical stimulation on improving the visual acuity in subjects with vision loss from dry     (non-neovascular) age-related macular degeneration (AMD) over a 6 week period.   "
56952|NCT02540135|"     This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance     Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of     tumor tissue during surgery.      Both fluorescein and intraoperative MRI have been studied and routinely used to aid the     neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely     resect more tumor tissue during surgery.      This study will enroll patients with malignant high grade glioma who are going to have a     surgery to remove their brain tumor.      For half of the patients, fluorescein and intraoperative MRI will be used together during     surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI     is used as final verification of complete, safe resection in both arms.   "
56953|NCT02540122|"     This is a pilot evaluation to assess the feasibility of using novel imaging process to     characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and     blink; and conjunctival microvasculature including fractal analysis of microvascular     perfusion maps and blood flow velocity.   "
56954|NCT02540109|"     This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment     of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as     alternate outcome measures, subject selection criteria, and benefits of extended treatment     duration. These results will be compared to an existing trial using conventional non-targeted     tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while     performing computerized anomia treatment. The basis behind this method is that language     therapy is mediated by cortical areas that are most effectively activated during the training     tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To     better understand the long term benefits of the adjunctive treatment, patients will be     screened again four weeks and six months after study using the same anomia tests. If HD-tDCS     shows promising results in increasing the learning outcomes of anomia treatment, a Phase III     trial can be considered.   "
56991|NCT02539602|"     This trial evaluated the impact of N2K, a three-year quasi-experimental study to delay sexual     initiation and increase condom and contraception use among high school students. The program     was administered to treatment students beginning in the fall of 2012 (9th grade) and     continued through the spring of 2015 (11th grade). The purpose of this study was to measure:     1) the impact of N2K on sexual initiation at the end of the three-year program and 2) the     impact of N2K on condom or contraception non-use at the end of the program.   "
59108|NCT02511860|"     This is a study of women aged 18-65, to determine the physiological effects of consuming     burdock root in supplement form. Burdock has long been used by herbalists for its diuretic     and blood sugar lowering properties.   "
56955|NCT02540096|"     Stroke is a neurovascular event characterized by impaired blood supply to the brain due to     rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and     can affect individuals of any age and sex, being prevalent in the elderly population.      Among the main treatments available for stroke rehabilitation, most of them demands an     appropriate structure and high-qualified personnel. Searching for more affordable treatment     options, several studies suggest the use of mental practice with motor imagery as a potential     therapeutic tool, since it can be performed at any place or any time the patient wishes,     including their own homes.      Motor imagery can be defined as the covert cognitive process of imagining a movement of your     own body(-part) without actually moving that body(-part).      Within this context, the objective of this study is to investigate the effects of mental     practice for mobility, gait function and speed and muscle strength of the lower limb in     subacute post-stroke hemiparesis.   "
56956|NCT02540083|"     The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on     both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with     other subject data including histology results from biopsy specimen examination and cancer     classification data from initially asymptomatic women referred for clinically indicated     breast biopsy based on suspicious DBT screening breast imaging results. These data will be     included in a subsequent and prospectively planned pooled analysis described in a separate     protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and     other performance measures.   "
56957|NCT02540070|"     Patients undergoing primary total knee replacement will receive either motor sparing knee     block to be performed by anesthesia or periarticular local anesthetic infiltration at the end     of surgery by surgeons to assess pain relief as well as capacity to ambulate early. The motor     sparing knee block will be performed prior to surgery using ultrasonography and the effect of     adding dexmedetomidine, an alpha 2 agonist to the injectate with regards to prolonging the     duration of analgesia will be assessed.   "
56958|NCT02540057|"     We are investigating the use of the flexor carpi radialis and abductor pollicis longus     tendons in the use of trapeziectomy and ligament reconstruction with tendon interposition.     Previous studies have shown clinical equipoise, and we plan to do a randomized controlled     trial to further assess.   "
56959|NCT02540044|"     This proof-of-concept randomized trial evaluates the effectiveness of using an on-line     decision aid (ANSWER-2) in the decision making to start or switch biologic therapy in     Canadian patients with rheumatoid arthritis.   "
56960|NCT02540031|"     Although adequate bowel preparation is essential for successful colonoscopy, the 23% of     patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in     incomplete examination, increased patient's discomfort, decreased polyp detection rates,     ultimately leading to repeated colonoscopies. One prior study showed that patients reporting     their last rectal effluents as brown color or solid stool had a 54% chance of having fair or     poor preparation. Thus, recent consensus guideline suggested consideration of additional oral     preparation in patients presenting brown effluents on the day of colonoscopy. However, the     data supporting additional oral preparation is still spares. Therefore, the investigators     aimed to examine the impact of additional oral preparation on the quality of bowel     preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.   "
56961|NCT02540018|"     The aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor®     paclitaxel drug‐eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting     restenosis and in ensuring long‐term patency.   "
56962|NCT02540005|"     The main purpose of this study is to analyse the on-going coagulation process after aSAH. For     investigation the investigators use the rotational thromboelastometry (ROTEM) which is a     point-of-care test using a variety of activators to provide a targeted and a dynamic analysis     of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH     patients treated in Tampere University Hospital intensive care unit and 16 control patients     (elective craniotomy due to non-ruptured intracranial aneurysm.   "
56963|NCT02539992|"     Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement     (TKR) in a consecutive series of patients who meet the eligibility criteria.   "
57398|NCT02534259|"     The objective of this study is to develop methods for using forces measured on circular     external fixators to predict the state of individual patient's healing of severe tibial     fractures and defects.   "
56964|NCT02539979|"     A double blinded randomized controlled study comparing pre-procedural IV Paracetamol versus     IV placebo (normal saline). The patients will be randomized to either receiving IV     paracetamol or saline infusions before undergoing radiofrequency lesioning of two levels of     medial branch nerves of the lumbar facets. The primary outcome will be potential differences     in pain control. The secondary outcomes will be changes in quality of life (QoL) and     activities of daily living (ADLs). We will also be comparing potential differences in the     amounts of post-procedure pain medications taken by the patients in each wing of the study   "
56965|NCT02539966|"     The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable     Coronary Scaffold in native coronary arteries.   "
56966|NCT02539953|"     One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure.     The investigators intend to monitor the ambulatory blood pressure of such patients in order     to assess whether this is a true haemodynamic effect.   "
56967|NCT02539940|"     The aim of this observational study is to evaluate the outcomes and safety of the     Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease     (PAD) in below-the-knee vessels   "
56968|NCT02539927|"     Patients will be treated in accordance with the standard medical practice of the hospital     where they have been recruited during their participation in this study. No additional     assessments or tests will be required.      SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing     endocrinologists to manage acromegalic patients and disease activity in their clinical     practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S;     Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth     factor 1(IGF-1) concentration -I; Tumour size- T.      The instrument has been pre evaluated during a qualitative pilot study. The purpose of the     validation study is to define and validate the scoring of the SAGIT® instrument.   "
59109|NCT02511847|"     [Background]: Triple-negative breast cancer (TNBC) is defined by a lack of expression of both     estrogen and progesterone receptor as well as human epidermal growth factor receptor 2     (HER-2). TNBC is characterized by distinct molecular, histological and unfavorable clinical     features despite the high rates of response to chemotherapy. Based on the above reasons, it     is important to emergently develop novel therapies and/or treatment strategies to increase     treatment efficacies and the survival rate of TNBC.      [Rationale]: Overexpression of epidermal growth factor receptor (EGFR/ErbB1) and EGFR     mutation have been reported in TNBC and may therefore be a valid target for anti-tumor     therapy in TNBC. Afatinib (BIBW 2992) is an ErbB-family blocker that irreversibly inhibits     signaling from all relevant ErbB-family dimers. Afatinib has demonstrated preclinical     activity in triple-negative breast cancer cell lines and xenograft models of breast cancer,     and clinical activity in phase I studies. Based on the assumption that uncontrolled     ErbB-signaling is directly related to an increased oncogenic potential in TNBC, the studying     afatinib in the neoadjuvant treatment of TNBC patients is important and provides a novel     therapy.      [Aims] The primary endpoint is to evaluate the pathologic complete response of the     combination of afatinib and weekly paclitaxel in TNBC patients receiving neoadjuvant     treatment. The secondary endpoints are to evaluate the clinical response and safety of     afatinib with and without paclitaxel, and to explore the different afatinib-affecting     downstream molecular pathways as well as potential biomarkers predicting the response of     afatinib with and without paclitaxel.      [Patients and methods]: Patients with TNBC (clinical T2-T3, N0-N1, M0; clinical T1-3, N1-2,     M0; or any T4a tumor) and received neoadjuvant treatment will included in this open, label,     multi-center phase II study. Our schema is as follows: (1) Afatinib 40 mg per day for 14     days, then evaluation, every subject will go into the following phase no matter whether she     had response or not (2) the following phase (the combination with afatinib and paclitaxel):     Afatinib 40 mg per day, day 1 to day 21, in combination with paclitaxel 80 mg/m² on days 1,     8, 15 in a 3-weekly course. In addition to the clinical assessment, we will evaluate the     potential predictive biological markers of activity of Afatinib with and without paclitaxel     and dynamic changes of molecular makers ([serum and tissue samples: before treatment, 2 weeks     after treatment, and operation timing]; potential molecules, such as EGFR, EGFR-signaling,     FGFR, FGFR-signaling, ERK, p53, NF-κB, and etc. were evaluated through the     immunohistochemical stains, mutation analysis, mRNA [RT-PCR], single nucleotide polymorphism     analysis, and FISH analysis). In addition, the genetic expression profiles will be compared     between afatinib-responsive and afatinib-unresponsive samples.      [Expected Results]: The promising clinical activity, tolerable toxicity, and potential     biomarkers of afatinib with and without paclitaxel in TNBC patients receiving neoadjuvant     setting will be demonstrated. The results from this study can be used to conduct a larger     trial that would allow us to confirm or validate the hypotheses generated.   "
56970|NCT02539901|"     Cochlear implantation enables profoundly deaf children to acquire speech and develop their     understanding of spoken language. However, there are significant interindividual differences     in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic     predictors, cognitive and language to obtain optimum speech recognition with cochlear     implants associated with a good communicative and language development of deaf children, the     investigators intend to achieve a preliminary longitudinal study aimed to describe the     cognitive, communicative and perceptive implanted deaf children.      The main objective of our study is to describe the cognitive and communicative development of     deaf children implanted from the pre-implant assessment to 18 months post-implantation, by     addressing the following aspects:        -  The psychomotor and cognitive development assessed using the Brunet-Lézine test;        -  The development of preverbal communication, evaluated using the Early Social          Communication Scale.   "
56971|NCT02539875|"     Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily smokers     10.8% (Census and Statistics Department, 2013) and half will be killed by smoking (Lam, 2012)     which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, & Peto, 2001). Smoking     also accounts for a large amount of medical cost, long-term care and productivity loss of     US$688 million (0.6% Hong Kong GDP) (Census & Statistics Department, 2001; McGhee et al.,     2006) . Smoking is a highly addictive behavior and it is difficult for smokers with strong     nicotine dependence to quit without assistance. On the other hand, reaching and helping the     many smokers who have no intention to quit is a challenge, because they are unlikely to seek     professional help from smoking cessation services.      The Quit and Win programme provides an opportunity to reach and encourage a large group of     smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that     smokers participating in the contest will have higher motivation to quit with incentives and     better social support (Cahill & Perera, 2011). Studies have found that such quitting contests     or incentive programs appeared to reach a large number of smokers and demonstrated a     significantly higher quit rate for the quit and win group than for the control group (Cahill     & Perera, 2008).      Smoking cessation services in Hong Kong are under-used with more than half (60.9%) adult     daily smokers who had never used smoking cessation services (Census and Statistics     Department, 2013). Among these smokers only 9.6% were willing to use the services. Existing     services mostly require self-initiation to seek the services but smokers general lack the     will power of initiation. Active referral will help overcome the barriers of self-initiation.     There is preliminary evidence that active referral of smokers to smoking cessation hotline     services may increase likelihood of smoking abstinence at 12-month follow-up compared with no     active referrals (Borland et al., 2008). A recent study has also reported that individuals     who used the community-based referral were also more likely to quit than those who did not     (43.6% vs 15.3%, P<0.001) (Haas et al., 2015).      Therefore, the present study will examine (1) effectiveness of the active referral and AWARD     approaches, (2) explore the use of CBPR model to build capacity and to engage community     partners in taking on this important public health issue for sustainability in the community.     In addition, process evaluation will be conducted to assess the effectiveness of the     recruitment activity and how it is linked with the overall program outcomes.   "
56972|NCT02539862|"     The purpose of this study is to evaluate the effectiveness of the management of chronic     primary insomnia patients by a computer program guidance of behavioral and cognitive     therapies for insomnia (BCT-I).   "
56973|NCT02539849|"     FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease   "
56974|NCT02539836|"     With the rapid development of society and economy, children's simple obesity is the rising in     the world and has become a chronic disease which is one of the biggest public health     challenges in the world. It is a serious threat to the health of children and their     adulthood. The overweight and obesity is induced by the genetic and environmental factors.     The environmental factors are very important, while the dietary factors are the driving     factors of many chronic diseases including obesity. This study focus on the dietary     intervention of childhood obesity to build healthy intestinal flora. The interventing food     was based on a natural health food - fruit and vegetable fermentation liquid, and combined     with other probiotic dietary factors, dietary fiber and oligosaccharides. The implementation     of the study will help to reveal the fuction mechanism of intestinal bacteria in the obese     children and normal children, and to construct healthy micro environment of intestinal flor.     According to the positive effect factors, the study will propose a healthy diet and nutrition     intervention model for obese children, which is significant to social health especially to     children's health.   "
56975|NCT02539823|"     Despite the current available therapies for opioid-dependent patients, most patients relapse.     This research project focuses on the development of a novel compound, cannabidiol, to     modulate opioid craving in humans based on animal models showing its selective effectiveness     to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse     would be of tremendous medical and public health value.   "
56976|NCT02539810|"     The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded     endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting +     standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration     in patients with confirmed resistant hypertension (RH) and angiographically proven grade III     unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.   "
56977|NCT02539797|"     This study will examine the benefits of transcranial direct current stimulation (tDCS), a new     tool that is being developed as a safe and non-invasive neurostimulation method, for     improving neurocognitive and social cognitive functions in schizophrenia. This procedure is     non-invasive and painless and it results in increase or decrease of spontaneous neuronal     firing in the brain. Its safety and beneficial effect on cognition has been demonstrated in     healthy individuals and several clinical populations. In this pilot study, the investigators     will examine the effect of tDCS on cognitive functions in 40 individuals with schizophrenia.     Each participant will arrive for three visits, with approximately one week between each     visit. During the first visit, participants will be interviewed about their psychiatric     symptoms, personal life experiences, and emotional well being by a specially-trained     interviewer. On each of the three visits, participants will receive one of three     stimulations: a type of tDCS designed to increase neuronal firing, an alternative form of     tDCS designed to decrease neuronal firing, and a sham tDCS (stimulation with no current).     Immediately following the stimulation, participants will be asked to complete measures of     mental abilities, including tests presented on a computer screen and paper-and-pencil tests.     During each visit, participants will also undergo a standard measure of brain activity (EEG)     while listening to tones. The first visit will last approximately five hours, and the other     two visits will last approximately four hours each. The project will take approximately two     years to complete.   "
56992|NCT02539589|"     The purpose of the study is to determine the impact of the offer to participate in Becoming a     Responsible Teen (BART) (treatment) relative to the offer to participate in Healthy Living     (control) on two self-reported sexual behaviors (condom use and frequency of sex) six months     after the end of treatment.   "
56978|NCT02539784|"     Following the so call honey moon period, motor symptoms of Parkinson's Disease (PD) become     difficult to control with dopaminergic treatments alone. Deep brain stimulation (DBS) of the     subthalamic nucleus and internal globus pallidus helps to treat fluctuating parkinsonian     patients restoring a decent quality of life. However, DBS need a long, complex and invasive     surgery to succeed. Thus, there is a critical need to develop alternative treatments, more     accessible and less invasive. Thoracic posterior spinal cord stimulation has been used for     decades to treat chronic neuropathic pains. Safety and efficacy have already been     demonstrated in neuropathic pain. Experimentally, SCS has also demonstrated to improve     locomotor activity in two different rodents' models of parkinson's disease. The purpose of     this study is to determine whether thoracic SCS is safe and could induce a benefit motor     parkinsonian symptoms without any impact on cognitive function and axial disability.   "
56979|NCT02539771|"     Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in     adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea     syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep     Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations     (nocturnal desaturation) favour nocturnal VOC.      The confirmation of this hypothesis will lead investigator to propose a systematic screening     of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic     treatment of OSA in sickle cell patients could help significantly reduce the number and     severity of nocturnal VOC.   "
56980|NCT02539758|"     Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma.     The effect of ocular massage on intraocular pressure in patients with acute primary angle     closure was the important thing.This was a prospective study, in which 20 eyes from 20     patients had acute angle closure. When they went to the hospital, ocular massage was     performed without any medication. Intraocular pressure was detected by Goldmann tonometer,     and Lenstar LS900 optical biometry observed changes of anterior chamber depth before and     after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were     observed by Ultrasound biomicroscopy after massage, and anterior chamber angle was also     checked by gonioscope after massage.   "
56981|NCT02539745|"     This study investigated whether vitamin D receptor gene polymorphism is altered in primary     open-angle glaucoma subjects carrying the risk allele and vitamin D deficiency is an     important factor in the development of glaucoma. Primary open-angle glaucoma patients and     age-matched people in the Han population were enrolled. Serum levels of 1a,     25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay. Vitamin D     receptor polymorphic analysis was studied by real-time polymerase-chain reaction high     resolution melting analysis.   "
56982|NCT02539732|"     Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a     patient is ready to be weaned from the ventilator based on breathing pattern measurements.     The T-piece technique allows clinicians to calculate breathing patterns accurately but many     prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern.     The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt)     supposedly represents what the patient really wants: without disconnecting the patient from     the ventilator, it may be possible to determine what is the real need and whether the patient     is able to maintain Vt without support. The aims of the study are as follows: to test whether     the changes in Vt after the removal of a standardized level of NAVA assistance (ΔVt) can     predict weaning outcome; to compare the proposed titration of effort in NAVA (occlusion) with     Patient-Ventilator Breath Contribution (PVBC) and titration using the Pmusc/Eadi index (PEI)     relating the pressure generated by the respiratory muscles (muscular pressure; Pmusc) to the     electrical activity of the diaphragm (EAdi); to assess the effect of PEEP on the change in     Vt; and to evaluate EAdi after extubation. Patients ventilated for at least 24 hours who are     ready to undergo an SBT will be included. Patients younger than 18 years of age and/or who     have a contraindication to NAVA catheter insertion and/or surgical patients expected to be     extubated within 12 hours will be excluded. After a baseline inclusion period with the     pre-enrollment mode of ventilation, the standardized NAVA level will be applied for 20     minutes, during which both Patient-Ventilator Breath Contribution (PVBC) and PEI will be     calculated. After the NAVA trial, a period of Continuous Positive Airway Pressure (CPAP) 5     (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both with NAVA gain 0) will be     performed in order to record the difference with Vt during standardized NAVA (ΔVt). At the     end of this period, the patient will be switched back to the baseline settings for 30     minutes-3 hours. After this period, the patient will perform an SBT with CPAP 0 or CPAP 5 for     1 hour. At the end of the SBT, the attending physician will decide whether or not to extubate     the patient according to standard criteria and blinded to the ΔVt results. Ultimately,     patients will be classified as success or failure and the ΔVt will be compared between     these two groups.   "
56983|NCT02539719|"     This is a Phase 1a/1b study of SC-003 in patients with platinum-resistant/refractory ovarian     cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked     to a potent chemotherapy.   "
56984|NCT02539706|"     This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half     of participants will receive follicular phase, while the other half will receive luteal     phase.   "
56985|NCT02539693|"     Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as     well as in the recovery room. In addition, decreased hospital stay and postoperative     analgesic consumption.      Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it     would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine     versus 150µg/mL.   "
56986|NCT02539680|"     The aim of the present study is to study the expression of the various phosphate transporters     in patients with normal or moderately impaired renal function or in patients on dialysis. In     particular, the investigators want to clarify whether NaPi-IIb expression level decreases in     CKD patients, which would render it a potentially inadequate pharmaceutical target in these     patients.   "
56987|NCT02539654|"     The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic     Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects,     immediately after bilateral tympanostomy tube surgery.   "
56988|NCT02539641|"     The study evaluates the gastric emptying by scintigraphy in patients that had bariatric     surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight     loss and in patients before and after the placement of a duodenal-jejunal bypass liner.      Additional, after bariatric surgery gut hormones that influence the gastric emptying rate are     determined.   "
56989|NCT02539628|"     The investigators believe sufficient spread to all nerves within the adductor canal—and     thereby sufficient analgesia—can only be obtained by bolus injections and not by continuous     infusions via a catheter. The aim of the study is to investigate whether an adductor canal     block performed as repeated intermittent boluses provides superior pain relief to continuous     infusion. The investigators hypothesize that adductor canal block performed as intermittent     boluses via a catheter will reduce morphine consumption and pain as well as enhance     ambulation and muscle strength compared with continuous infusion.   "
56993|NCT02539576|"     The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg     fixed-dose combination (FDC) tablet is currently approved in the United States (US) and     Europe. Although the pharmacokinetics (PK), safety and tolerability of ABC/DTG/3TC FDC     tablets have been extensively studied in subjects not of Japanese heritage, these parameters     have not been exclusively assessed in Japanese subjects. To support the marketing application     in Japan, this single-dose, open-label study will characterize the PK, safety and     tolerability of ABC/DTG/3TC FDC tablet in adult Japanese healthy subjects. A maximum of 12     subjects will be enrolled such that approximately 10 evaluable subjects complete the study.     The study will consist of a screening, treatment phase (single oral dose under the fasted     state) and follow-up visit (within 7-14 days of the last PK sample collected). The total     duration of the study for each subject will be approximately up to 48 days.   "
56994|NCT02539563|"     Labor patients who meet inclusion and exclusion criteria will be consented to be participate     in this study to determine if the use of a peanut shaped birthing ball reduces the length of     labor and reduces the incidence of cesarean section. Subjects will be randomized at the time     of consent to either use the birthing ball or not use the birthing ball from the time of     labor analgesia until complete cervical dilation.   "
56995|NCT02539550|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     PF-06266047 after first-time administration to healthy adult subjects.   "
56996|NCT02539537|"     French national multicentric phase III trial evaluating chemotherapy with Folfirinox or     gemcitabine in locally advanced pancreatic carcinoma   "
56997|NCT02539524|"     The aim of this study is to investigate weather the breathing exercises of Yoga are effective     in altering clinical impact, anxiety, depression and quality of life in Chronic Obstructive     Pulmonary Disease patients.   "
56998|NCT02539511|"     Alcohol use disorders remain a significant public health problem. The pharmacological     facilitation of behavioral treatment represents a promising strategy for addressing     disordered drinking. Alcohol use disorders are recognized to be associated with various     vulnerabilities that complicate the course of treatment and that may be amenable to glutamate     modulators. The purpose of this randomized, double-blind, controlled trial is to test various     glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol     use disorders.   "
56999|NCT02539498|"     Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by     Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact of     excessive parathyroid hormone (PTH) secretion. High-Resolution peripheral Quantitative     Computed Tomography (HR-pQCT) assesses separately cortical and trabecular bone sites as well     as geometric characteristics of peripheral skeleton. In postmenopausal women, HR-pQCT has     shown that decreased microarchitectural parameters are associated with reduced bone strength     independently of BMD. The purpose of this study is to characterize the impact of PHPT in     cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed     for one year, in comparison with control postmenopausal women.   "
57001|NCT02539472|"     Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the     accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches     and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and the     differential diagnosis with inflammatory dermatoses is often very difficult. The     histopathological diagnosis is also difficult and delayed. Therefore, it is important to     develop biomarkers and/or a combination of biomarkers in order to improve the early     diagnostic of MF.      In a previous trial, investigators included 490 patients in a study aiming at identifying     skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be     interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later     evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This     French institutional study demonstrated that the identification by PCR of a combination of 4     blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis     of lymphoma in erythrodermic patients. This previously published study interestingly showed     that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the     blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic tool     for MF.      The aim of this study is to establishing an accurate blood diagnosis for early suspected MF     by demonstrating that newly identified biomarkers or their combination [5 cutaneous KIR     receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX,     Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)] are differentially expressed by patients with MF     and patients with inflammatory dermatoses closely resembling MF lesions.      Statistical analysis will establish the best combination of blood biomarkers allowing the     differentiation between the two groups of patients, combination that could represent a     suitable diagnostic tool for early MF.   "
57002|NCT02539459|"     The purpose of this research study is to see if oral everolimus is tolerable and effective in     the treatment of sporadic Angiomyolipomas (AMLs). AMLs are the most common non-cancerous     tumor of the kidney. They are composed of blood vessels, muscle cells and fat     cells.Everolimus is already an approved drug for several other diseases like kidney cancer,     but is being studied now specifically to see if it is helpful for people with AML.   "
57003|NCT02539446|"     Inherent with intricate allocation of brain resource and attention shift,     postural-suprapostural task is defined as postural control takes place while the other     concurrent task is being performed. Recent studies have indicated that attentional focusing     alters attention allocation in the brain as well as motor performance of a     postural-suprapostural task. Also, most studies have demonstrated benefits of inducing an     external focus relative to internal focus for motor performance. However, postural difficulty     might be a critical factor for choosing an appropriate focusing strategy, and the strategy     used in a particular difficulty level do not always generalize to other difficulty levels.     Besides, despite a lot of studies have been done, current findings are confined to behavioral     observations in young healthy adults for lacking direct neural evidence. With the uses of     H-reflex, event-related potential and behavioral measures, the purpose of the 3-year research     project is to investigate the differences in performance quality and intrinsic neural     mechanisms of a postural-suprapostural task for older adults and patients with Parkinson's     disease, by adopting external and internal strategies for suprapostural task under different     posture difficulties. In the first year, the investigators will characterize suprapostural     focusing effect on reciprocity of a postural-suprapostural task, with a special focus on     modulation of motoneuron excitability in sitting and standing posture for healthy young and     older adults using H-reflex technique. In the second year, the adaptive selection of     suprapostural focusing strategy will be investigated for patients with Parkinson's disease by     varying the standing surface (stable/unstable surface). In the third year, the investigators     will investigate suprapostural focusing effect on brain resource allocation for patients with     Parkinson's disease, in light of event-related potential and movement-related potential. The     present project is expected to have significant contributions not only to gain a better     insight to neural correlates of concurrent postural and motor suprapostural tasks with     internal/external focusing strategy under different posture difficulty, but to optimize     treatment strategy for older adults and patients with Parkinson's disease with balance or     multi-tasking disturbances.   "
57004|NCT02539433|"     Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is     suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET     and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a     similar protocol as they had used for PET (Positron emission tomography) or FDG     (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States     Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation     Safety Committee in 1989 and 1994 for the study of neurological diseases and used     uneventfully.   "
57005|NCT02539420|"     Though BiPAP is an increasingly common tool used by pediatric critical care physicians and     there is promising data suggesting a role for BiPAP in the management of status asthmaticus,     more information is needed to more definitively clarify the extent of its benefit, as well as     when during an asthma exacerbation and in whom it is the most beneficial. In this study,     which is among the first randomized studies of BiPAP use for status asthmaticus in the     pediatric population, the investigators hope to better elucidate these issues to help guide     clinicians' future management decisions.   "
57006|NCT02539407|"     Concentrations and effects of anti-infectives in critically ill children are unpredictable     and the risk of under-exposure may be associated with poor clinical outcomes. In addition,     between-subject variability (BSV) is known to be substantial in critically ill children.     Rationalisation of anti-infectives in children is therefore desirable.      The investigators aim to investigate, using a population approach, the pharmacokinetics (PK)     and pharmacodynamics (PD) of anti-infectives including PK/PD targets (fT(%) > minimal     inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill     children. Covariates The effects of covariates on anti-infectives PK and PK/PDs are     investigated in order to better explain the BSV and to ultimately suggest individualized     dosage regimens.      It will be a prospective PK study including 11 anti-infectives antibiotics. Six blood samples     were taken from each patient during dosing interval. The primary PK/ PD targets were     anti-infectives concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and     100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic regression     to describe the effect of anti-infectives exposure on patient outcome.   "
57007|NCT02539394|"     The purpose of this study is to determine what effect intraoperative topical steroids have on     reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.   "
57008|NCT02539381|"     Visual impairment can affect up to 70% of stroke survivors, but many do not have their vision     adequately assessed in hospital. An unidentified visual defect can cause significant problems     for recovery and quality of life. The Stroke Vision app (an application currently scaled for     a 10 Android tablet) has been developed to act as a screening tool for visual problems in     stroke survivors; to help identify visual problems earlier and thereby improve rehabilitation     outcomes. The app includes a suite of tests for assessing the patient's acuity, their visual     fields and to aid in the identification of visual neglect / inattention. Furthermore, it     includes educational information on visual stroke in order to better educate staff, patients     and their carers. This study seeks to validate the novel digital assessments included in the     Stroke Vision app against the current methods used for screening (clinical examination by     confrontation field testing). Both screening measures will be compared with the gold standard     methods for visual assessments, Octopus perimetry for fields and paper-based methods for     visuospatial neglect   "
57220|NCT02536586|"     The main purpose of this study is to evaluate the tolerability of an investigational drug     known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to     another part(s) of the body. The study will also explore the safety of the drug. It will     measure how much of the drug gets into the blood steam and how long the body takes to get rid     of it. It will investigate anti-cancer activity.   "
57009|NCT02539368|"     This is a post-marketing observational study of patients with Inflammatory Bowel Disease     (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra     (infliximab) or Remicade (infliximab) for treatment. Inflectra is a biosimilar medicine to     Remicade, meaning it is a biologic medicine that contains the same active substance as     Remicade (infliximab). The key study objectives are as follows:        -  To characterize the population and drug utilization patterns of patients treated with          Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard          of care Remicade        -  To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of          patients with CD or UC in the context of standard of care Remicade        -  To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in          the context of standard of care Remicade        -  To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD          or UC        -  To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work          productivity and healthcare resource utilization (HRU) in patients treated with          Inflectra for CD or UC   "
57010|NCT02539355|"     Obesity is a risk factor for several common cancers, including those of the breast, colon,     liver, and pancreas. Proposed molecular links between obesity and these types of cancer     include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of     sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic     inflammatory processes in expanded adipose tissue. The objective of this proposal is to test     the hypothesis that adipose tissue inflammation can be reduced by the foods we eat.   "
57011|NCT02539342|"     The purpose of this study is to determine if the administration of Caphosol rinse, at the     start of chemotherapy, will prevent the development of mucositis (greater than or equal to     grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.   "
57012|NCT02539329|"     Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are     responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple     etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody     is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that     other antibodies can be discovered in patients who remain seronegative changing.      However, the study is retrospective and only a small number of patients could be identified.     Several points therefore need to be clarified or confirmed in a second prospective study.   "
57034|NCT02539043|"     The aim of this study is to evaluate the effect of cavitation ultrasound focused on localized     adiposity and its effects associated with stereodynamic lymphatic drainage. The investigators     aim also to know if this procedure will influence the biochemical profile of the individuals     concerned, as well as whether it will be found difference between the group that will receive     focused ultrasound cavitation associated with stereodynamic drainage and the group will     receive only focused cavitation ultrasound.   "
57035|NCT02539030|"     This study was designed to evaluate the efficacy and safety of a modified microfracture using     collagen, and to compare them with those of a simple microfracture to prove the     non-inferiority of the modified microfracture using collagen in patients with cartilage     defects in their knees.   "
57013|NCT02539316|"     Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's     nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity,     cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the     context of a long-term PN especially in premature infants. It results in an increase in     gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied     in the adult population and in the preterm in the PN on short and long, with the finding of a     hepatoprotection. Investigators do not find a single retrospective study about it in     Pediatric Onco-Hematology. No prospective studies have been performed in the population of     Onco-Hematology. The objective of this study is to evaluate the impact of the use of     SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with     Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric     population.   "
57014|NCT02539303|"     This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5     (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower     extremities in patients with severe peripheral arterial disease (PAD) who were deemed to have     unreconstructable arterial disease and who have already been scheduled to undergo limb     amputation (below knee or above knee amputation).   "
57015|NCT02539290|"     The purpose of this study is to determine whether preovulatory uterine flushing with     physiological saline is effective in the treatment of unexplained infertility.   "
57016|NCT02539277|"     Study topic：A comparative effectiveness research on Jinyebaidu granule in treating patients     with acute upper respiratory infection: A double blind, double dummy, randomized, controlled     trial. It is a post-marketing clinical study to evaluate effectiveness, safety and     cost-effectiveness on Jinyebaidu granule in treating acute upper respiratory infection.      Objectives of Study：This study aims to evaluate effectiveness, safety and cost-effectiveness     on Jinyebaidu granule in treating patients with acute upper respiratory infection.      Study design：multi-center double-blind, double-dummy, randomized, controlled trial   "
57017|NCT02539264|"     In this study the investigators will analyze the influence of smoking, benzodizepine use, and     obesity among patients with severe Obstructive Sleep Apnea (sOSA).   "
57018|NCT02539251|"     Early detection and intervention for developmental delays are crucial in promoting healthy     child development, hence the need for formal screening. In the Arabic speaking population     developmental screening tools are scarce in the native language and there is a need for such     a tool for pediatricians and health care workers to use routinely.      This study aims to translate, adapt and validate the newest version of ASQ (ASQ-3) to Arabic     (A-ASQ-3) based on the previously published study showing that ASQ-2 was culturally     sensitive.      The previously translated A-ASQ-2 will be revised and updated to match the new ASQ-3, then     revised by experts in child development. Questionnaires will be adapted and field-tested on     15 subjects per age group (total of 75). For validity, the revised version will be tested on     500 Lebanese children (100 children per age group) selected from all Lebanese governates.      It is expected to generate a culturally adapted and validated Arabic tool for screening     children for any developmental delay up to 3 years of age. This tool once published will be     available for use by primary care providers and caregivers in Arabic speaking countries. It     may be used to screen children for developmental delay as early as 7 months therefore     prompting prevention of further delay by starting early intervention and promoting child     development.   "
57121|NCT02537886|"     The Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be     developed as a patient-centered web-based mobile application and will be able to run on     mobile devices. The development of VIC is to create a reusable infrastructure for integrating     the informed consent process into clinical care and the clinical workflow in a way that     enhances patient comprehension while improving the efficiency of obtaining patient consent.   "
57019|NCT02539238|"     Objectives: The primary objective of this project is to assess whether the implementation of     a new cardiopulmonary resuscitation (CPR) training program (longitudinal training with     real-time feedback) can improve CPR quality of healthcare providers compared with traditional     training method. The secondary objective is to identify whether the implementation of the new     training program will result in cost-effectiveness.      Design: Randomized trial to compare new training program with tradition training method and     cost-effectiveness alongside this trial      Participants and setting: Paediatric healthcare providers in Emergency Department at Alberta     Children's Hospital. Subjects will be enrolled in either intervention (new training program)     or control (traditional training program) by random.      Statistical analysis: Investigators will conduct chi-square test and independent t-test to     compare the proportion of excellent CPR and 3 metrics of CPR quality of intervention group     with control group at the end of 12-month interval. A multi-level logistic regression and     linear regression models will be used to assess the effect of training method and time on     proportion of excellent CPR and 3 metrics of CPR quality. Investigators will also conduct a     full-economic evaluation in a health care system prospective. cost-effectiveness will be     expressed as cost per increased CPR excellence according to incremental cost-effectiveness     ratio (ICER). A one-way sensitivity analysis and a probabilistic sensitivity analysis will be     conducted to deal with uncertainty in effects and costs.      Conclusion: The new CPR training program will serve as an example of competency-based     psychomotor skill training program and help healthcare providers to improve quality of CPR,     and potentially improve the survival of children with cardiac arrest. The results of the     studies might provide evidence to inform and update in resuscitation education guideline to     change the way of CPR training and improve the cost-effectiveness of CPR training program.   "
57020|NCT02539225|"     The main purpose of this study is to evaluate the effectiveness of S-1 and oxaliplatin with     or without ramucirumab as first line therapy in participants with metastatic gastric or     gastroesophageal junction (GEJ) adenocarcinoma.   "
57021|NCT02539212|"     According to randomized controlled trial requirement, the therapeutic effectiveness of     cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular     carcinoma is compared to find a better approach for minimally invasive thermal ablation.   "
57022|NCT02539199|"     The purpose of this study is to investigate the effectiveness and safety of vaginally     administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in     induction of labour in nulliparous women.   "
57023|NCT02539186|"     The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of     musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for     regeneration of peripheral neuropathy in animal study, the associated study in human is rare.   "
57060|NCT02538692|"     The purpose of this study is to test the efficacy and safety of a traditional Chinese     medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome     (IBS-D).   "
57162|NCT02537340|"     The hypothesis to be proven with this study is that the use of PET/CT on the initial staging     of rectal cancers in patients with extramural vascular invasion detected by MR will detect     more lesions than conventional work-up and will significantly impact on therapeutic decision,     improving disease free and overall survival.   "
57024|NCT02539173|"     1. INTRODUCTION AND MAIN OBJECTIVES The incidence of diaphragmatic paralysis after an          inter-block scalénique varies between 30 and 100% in the literature. Its clinical impact          is mostly absent and paralysis regresses after the block lifted. When it is suspected,          it can be diagnosed by a chest radio, showing an elevation of the dome.           The objective of this study is to evaluate the incidence of diaphragmatic paralysis by          measuring the thickness diaphragmatic as quantitative assessment of diaphragmatic          contraction noninvasive ultrasound scan and feasibility of this measure in SSPI unit          (post-interventional monitoring unit) with scan (ultrasound) in the usual way used for          the block under ultrasound scan.        2. STUDY TYPE Prospective, single-center clinical study routine care involving 50          consecutive patients scheduled to undergo surgical procedures in the area of the          shoulder or arm for which locoregional analgesia inter-block type scalénique or          supraclavicular ultrasound scan is indicated below.        3. START OF THE STUDY February 2014 with an expected duration of six months.   "
57025|NCT02539160|"     Patients with diabetes mellitus (DM) are at increased risk of atherothrombotic events.     Importantly, DM is a key risk factor for the development of chronic kidney disease (CKD),     which further enhances atherothrombotic risk. Clopidogrel is the most widely used platelet     P2Y12 receptor inhibitor. However, despite its clinical benefit, patients with DM and CKD     frequently experience recurrent atherothrombotic events. Ticagrelor is an oral, reversible,     non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition     than clopidogrel. In large-scale clinical investigation, ticagrelor significantly reduced     ischemic events to a greater extent than clopidogrel, a finding that was consistent also     among DM patients. To date there has been no analysis on the efficacy of ticagrelor in DM     patients according to CKD status. Moreover, although PD studies showed enhanced platelet     inhibition associated with ticagrelor, it is unknown how this may be affected by CKD status.     Ultimately, how PK/PD profiles of different ticagrelor dosing regimens may be affected by DM     and CKD status is also unknown. The proposed study is aimed to show the impact of CKD status     among patients with DM and CAD on PD and PK profiles of ticagrelor used at 2 doses (90mg bid     and 60mg bid) in the setting of a prospective, randomized, cross-over trial.   "
57026|NCT02539147|"     Activation of caspase-4 and human caspase-5 (orthologs of caspase-11 in mice) in innate     immune cells.   "
57027|NCT02539134|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of     multiple rising doses of TAK-935 in healthy participants.   "
57028|NCT02539121|"     In this study, a single blind randomized trial with third party evaluation is carried out in     order to compare the postpartum blood loss when Ren Mai 6 point is stimulated and when this     point is not stimulated.      Investigators focus on measuring the volume of postpartum blood during the third stage of     labor and during the first two hours after birth. A significant reduction in the volume of     bleeding would imply a reduction in the rate of postpartum hemorrhage (PPH) (more than 500     ml) and the rate of severe PPH (more than 1000 ml).      The principal outcome of the study is the volume of postpartum blood, this volume is measured     by the midwife who is responsible of the birth. Collection of lost blood is initiated     immediately after birth of the baby by passing a blood collection drape under the woman's     buttocks.      The secondary outcomes are the influence of acupuncture in the placental expulsion time, and     the influence of the predictor variables in the bleeding volume and in the placental     expulsion time: primiparity or multiparity, number of gestation including abortions, doses of     oxytocin during labor, maternal age, maternal weight in the beginning of the gestation,     maternal ponderal gain during pregnancy, date of the last blood test during pregnancy and     value of hemoglobin and hematocrit, spontaneous labor or induction by means of oxytocin or     prostaglandins, spontaneous or artificial rupture of membranes, first stage of labor     duration, second stage of labor duration, hours since rupture of membranes, hours since     epidural analgesia, volume of serotherapy during labor, and newborn weight. Possible     puerperal complications or security problems, the degree of Satisfaction of the Mother and     the degree of ease with which the acupuncturist administered the treatment are also secondary     outcomes.   "
57399|NCT02534246|"     The aim of this study is to evaluate and compare the diagnostic accuracy and specimen     adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy     regimens, with respect to diagnosis of solid pancreatic lesions.   "
57029|NCT02539108|"     The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of Fluzone     Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the     Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to     < 9 years of age.      Objective:        -  To describe the safety of the 2015-2016 formulation of Fluzone Quadrivalent vaccine,          administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in          children 6 months to < 9 years of age.      Observational objectives:        -  To describe the immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP          recommendations, in children 6 months to < 9 years of age.        -  To submit available sera from each subject to Center for Biologics Evaluation and          Research (CBER) for further analysis by the World Health Organization (WHO), the Centers          for Disease Control and Prevention (CDC), and the FDA to support formulation          recommendations for subsequent influenza vaccines.   "
57030|NCT02539095|"     The primary objective of this study is to confirm the superiority of intra-articular collagen     injection in patients with knee joint pain compared to the control group. 100mm VAS is used     to measure the pain of the subjects 24 weeks after the procedure.   "
57031|NCT02539082|"     The primary objective of this study is to evaluate the safety and efficacy of collagen     injection in patients with plantar fasciitis   "
57032|NCT02539069|"     A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous     cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and     safety evaluation with 96 weeks follow-up in patients with knee cartilage defects.   "
57033|NCT02539056|"     A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous     cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects     in their knees.   "
57075|NCT02538484|"     Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese,     postmenopausal breast cancer patients.   "
57036|NCT02539017|"     As a special type of breast cancer, the triple negative breast cancer has the characteristics     of high recurrence rate (2 years after surgery), high distant metastasis rate, poor prognosis     and short survival time. No matter at home or abroad, the clinical researches of the triple     negative breast cancer are mainly focused on finding new drugs and new treatment strategies     in order to reduce its recurrence and distant metastasis rate. The DC/CIK cell immunotherapy     combined with chemotherapy in the clinical study of metastatic triple negative breast cancer     has already confirmed benefit. This study is based on the theory that the optimal timing of     cellular immunity is while the host tumor load is under the smallest state. Put forward the     hypothesis that the DC/CIK cell immunotherapy combined with chemotherapy may improve the     disease-free survival and overall surviva after the triple negative breast cancer operation.     The investigators intends to use the RCT, observing the clinical significance of cellular     immune adjuvant therapy of triple negative breast cancer in 340 patients with TNBC. Do the     safety evaluation of cellular immunity in the adjuvant treatment of breast cancer treatment,     explore the clinical strategies for breast cancer immunotherapy.   "
57037|NCT02539004|"     Urolithiasis is a universal problem, a large part of patients will be affected by multiple     stones throughout their lifetime, with estimated recurrence rates of 75% within 20 years. The     high recurrence rate requires an increasing amount of imaging follow-up. US-NCCT real-time     fusion (Fusion) enables lesion assessment and follow up using both modalities as reference     for each other. Our study proposes a novel approach for short term follow up of patients     using Fusion instead of repeat NCCT exams.      the goal of the study is to create an initial proof of concept that Fusion is effective for     follow up of known urinary stones.      the study is a prospective study on Patients with an obstructing ureteral stone found on a     NCCT. Patients will undergo Fusion (using General Electric Logiq E9) after NCCT. The primary     endpoint was the ability to locate the ureteral stone using US with guidance of the NCCT as a     Road Map.   "
57038|NCT02538991|"     One out of three adult females suffer from daily urinary incontinence. Two thirds of urinary     incontinence is physical activity-related stress urinary incontinence (SUI). If the     first-line treatment for SUI, training of pelvic floor muscles, is insufficient, treatment     options are suburethral sling operation or transurethral bulking injection. Randomized     studies between TVT and Bulkamid® and the knowledge about cost-effectiveness and patient     satisfaction is missing.      This prospective randomized study compares TVT and Bulkamid®-injections in treatment of SUI.     Main outcome measures are patient satisfaction, complications and effectiveness of the     treatment in reducing urinary leakage. Secondary outcome measures are cost-effectiveness,     pain during and after treatment and changes in Quality of Life and symptoms.   "
57039|NCT02538978|"     This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal     clinical study in which subjects are evaluated for prevention of major limb amputation in the     treatment of non-reconstructable Rutherford Category 5 critical limb ischemia (CLI). Subjects     will be randomized in 3:1 ratio (device treatment: placebo-control).   "
57040|NCT02538965|"     To determine the activity of lenalidomide in the treatment of pediatric subjects with     relapsed/refractory AML (with second or greater relapse or refractory to at least 2 prior     induction attempts) measured by morphological complete response defined as either a CR or CRi     within the first 4 cycles of treatment.   "
57221|NCT02536573|"     This is a prospective, randomized study of total hip arthroplasty with and without the use of     Radlink surgical positioning software. The investigators are interested in discovering     whether the use of the Radlink software will provide more accurate acetabular cup position     when compared with surgeon estimates based on visual inspection of fluoroscopic images.   "
57041|NCT02538952|"     Background: In Botswana, as in the rest of sub-Saharan Africa, undiagnosed TB or TB diagnosed     late in the course of disease is thought to be the most common cause of death among     HIV-infected persons.      Interventions for Evaluation: The Xpert MTB/RIF assay for the GeneXpert platform (Xpert) has     a TB diagnostic sensitivity of 82.4%, significantly superior to that of smear microscopy     (44.6%). In line with WHO guidelines, the Botswana Ministry of Health (MOH) and CDC rapidly     rolled out the Xpert device and a new Xpert-based diagnostic algorithm in service of 22 HIV     care and treatment clinics. To maximize impact of the Xpert device in improving detection of     active TB, Xpert rollout was preceded by strengthening of TB screening procedures by: (1)     adopting the WHO-recommended 4-symptom TB screen for adults; (2) situating trained TB     case-finding nurses in facilities; and (3) training health facility personnel in TB     diagnostic algorithms. The combination of these strengthened TB screening procedures and     rollout of the Xpert device is referred to as the Xpert package in this protocol.      Key Evaluation Objectives: The protocol has two key objectives: (1) to evaluate whether the     new MOH-recommended Xpert-based TB diagnostic algorithm for new adult HIV clinic enrollees is     more sensitive than the pre-Xpert smear-microscopy-based algorithm in diagnosing     culture-positive TB disease; and (2) to evaluate the impact of the whole Xpert package on     all-cause mortality during the first 6 months of ART, among adult patients.      Design: Stepped-wedge cluster randomized trial. Sample Size: 6,136 patients were     prospectively enrolled to meet the first primary objective. A retrospective cohort of 10,131     persons was also enrolled to meet the second objective. Projected power to meet both     objectives is >80%.      Time line: Prospective cohort enrollment started in July 2012 and was complete by March 2014.     Retrospective cohort enrollment was complete by March 2015. Patient follow-up and data entry     will be complete in March 2016 at which time analysis to answer the first two primary study     questions will be possible.   "
57042|NCT02538939|"     Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder.     US- guided needling and lavage of the calcification is one of the therapeutic options after     failure of conservative management with physiotherapy and anti-inflammatory drugs. The goal     of this procedure is to remove the calcific deposit that is believed to cause the     sub-acromial impingement. However, studies have shown that complete and rapid disappearance     of the calcification deposit after irrigation is rare. The treatment is thought to promote     the spontaneous resorption that occurs the weeks and months after the procedure. However, due     to this slow process, time to complete recovery can be long. Moreover, it has been shown an     association between the amount of removed calcium and improved outcome. Therefore, there is a     need to find a way to remove quickly and completely the calcific deposit after irrigation.     Sodium thiosulfate has been used successfully in the treatment of calciphylaxis and     subcutaneous calcification deposit. The mechanism of action involves chelation of calcium     into calcium thiosulfate salts which are much more soluble than other salts of calcium. Our     hypothesis is that injection of sodium thiosulfate after irrigation of the calcification will     help to dissolve the calcific deposit and thus prompt the disappearance of the calcification.   "
57089|NCT02538302|"     Nocturnal enuresis is among the most common disorders in children. The aim of current study     was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal     enuresis in children in Bandar Abbas in 2014.   "
57043|NCT02538926|"     This phase II trial studies how well etoposide, prednisone, vincristine sulfate,     cyclophosphamide, and doxorubicin hydrochloride with asparaginase work in treating patients     with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such     as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Asparaginase     breaks down the amino acid asparagine and may block the growth of tumor cells that need     asparagine to grow. Giving combination chemotherapy with asparaginase may work better in     treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.   "
57044|NCT02538913|"     Cancer treatments often cause acute toxicity during treatment, and late toxicity after     treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction     are late side effects associated with cancer treatment in general, and patients treated for     pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329     in 2010. Advances in the treatment during the past few decades have led to fewer local     recurrences and increased long-term survival, and today the relative survival is 66% for     women and 64% for men. More patients are having sphincter-preserving surgery with low     colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70%     of the patients with curative surgery. Unfortunately, many patients experience altered bowel     function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal     incontinence are common and distressing complications. These functional disturbances are seen     in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant     therapy. Urinary incontinence and decreased sexual function is also common in both men and     women following rectal cancer treatment.      In many surgical settings, patients with higher preoperative physical fitness rehabilitate     more quickly and have fewer operative complications compared with patients who are less     physically fit. Additionally, specific strength training of the pelvic floor muscles builds     up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and     closes the levator hiatus thus providing improved structural support for the pelvic floor as     well as more optimal automatic function. The aim of the present trial is to investigate     whether exercise training including pelvic floor muscle training during preoperative     radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the     physiology of the anal sphincter muscle after LAR. In addition quality of life,     cardiopulmonary parameters and postoperative complications will be studied.   "
57045|NCT02538900|"     This proposed study will determine whether an exercise intervention that avoids continuous     supervision and exercise-related ischemic pain improves walking performance at 52-week     follow-up in people with PAD. Our intervention directly addresses two aspects of current     practice guidelines that are major barriers to exercise for patients with PAD: 1) the     recommendation for supervised exercise and 2) the recommendation for high intensity     ischemic-pain inducing walking exercise.   "
57046|NCT02538887|"     The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection     System (RFDS) as a non-radiological means to ease the process of detecting retained sponges     and reconciling sponge counts in the labor and delivery room (following vaginal birth).   "
57047|NCT02538874|"     The purpose of this study is to assess safety, to measure blood levels of drug, and to find     out what the drug does to the body.   "
57055|NCT02538770|"     Viral respiratory infections are common and often require use of health care resources.     Patients receive inappropriate bacterial antibiotics, which has many problems including     side-effects, development of resistance and costs.      A small portion of the infections leads to severe clinical manifestations including     hospitalisations and deaths. The significance of influenza virus is well known and it is     actively detected in all age groups. However, the benefits of detecting other respiratory     viruses have mainly been studied among children but not among adults. The development of     multiplex PCR technique has provided a new and sensitive method for diagnosing a large panel     of viruses. To convince the economical benefits of the rapid viral diagnostic in adult     infectious patient, more evidence is needed.      In our randomized study, nasal and pharyngeal samples from the patients evaluated at the     emergency clinic of internal medicine in the University Hospital of Oulu because of any     respiratory symptom, chest pain or fever, will be collected. The samples will be tested for     16 different respiratory viruses by using Anyplex TMII RV16 Detection. The adult participants     will be randomized in two groups. In one group the results of the testing will be reported     for the attending physician as soon as possible, and in the other group 7 days after     sampling. The effect of this delay to patient care is monitored. Also the results of children     and adults are compared as well as results of men and women. The hypothesis is that rapid     viral diagnostics shortens the length of admission and diminishes the use of bacterial     antibiotics. New information on the viral epidemiology among children and adults is provided     and clinical manifestations of specific viral infections in adults are described.      The estimated 1500 samples are also tested for 5 different respiratory bacteria by Anyplex TM     II RB5 Detection. These results will be examined after completion of the study period. The     benefits of rapid bacterial detection are evaluated in respect to the clinical course of the     disease and considering the infection control aspects as well.   "
57048|NCT02538861|"     This is a prospective open label two arms clinical trial. ARM-A patients will receive the     standard of care diagnostic test at Baptist Hospital Main (BHM), which includes Single Photon     Emission Computed Tomography (SPECT) imaging, while ARM-B patients will be randomized     sequentially into two groups; Group-1 will receive CT Angiography and CT myocardial perfusion     with new Revolution CT scanner (General Electric Healthcare) while the Group-2 will receive     SPECT imaging test; both groups of ARM-B at West Kendall Baptist Hospital (WKBH). The primary     hypothesis is that the combined evaluation of CT angiography with CT myocardial perfusion is     more efficient in detecting or excluding acute coronary syndrome resulting in early discharge     and decrease length of stay of patients from the Emergency Department (ED) compared to a     strategy with SPECT alone. The secondary hypothesis is that a strategy with CTA/CTP can     reduce direct patient care costs and potentially improve patient outcomes in the same patient     population when compared to a strategy with SPECT imaging alone.      The main purpose of this study is to have a definite ED chest pain admission triage, which     will help to reduce the length of stay and direct patient cost. This approach will reduce the     economic burden in intermediate risk group patients as well. We had a Baptist statistician     run the numbers. This study will provide important preliminary data to guide clinical     implementation of CTP/CTA in clinical practice. We divided arm B into two groups as the CT     protocol might be different at each hospital, so we want to reduce bias as a result of     variation in clinical patterns in the different hospitals. Also, we kept 50 patients in arm A     (Baptist hospital) to have a control group at the hospital level.   "
57049|NCT02538848|"     To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in     healthy volunteers   "
57050|NCT02538835|"     This study evaluates the effect of metacognitive group therapy on depression compared to     mindfulness groups and supportive groups. The participants, all with a history of depression     and with current symptoms of depression, will be randomized to one of the three group     interventions.   "
57090|NCT02538289|"     Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are     becoming more frequent. Patients suffering from dyspnea have a significant disabling due to     chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools     that may produce an improvement of symptom intensity, they are underused.   "
57051|NCT02538822|"     Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by     rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present,     the only parameter for assessing the risk of complication is the maximum diameter of the     aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal     aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal     circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when     the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm     in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos     syndrome). However, there are aneurysms with diameter greater than the surgical threshold     which remain stable. Conversely, complications have been described for aneurysms less than     4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the     risk of complication of an aneurysm of the ascending aorta.Multiple methods have been     described in the literature. One of them relies on in vitro mechanical testing on healthy or     aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound).     So far, no algorithm is robust enough for predicting the risk of complication better than the     universally used criterion of diameter.      The pathophysiology of these aneurysms has also been explored from histological studies. The     investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated     with a degradation of elastin fibers and collagen that determine to a large extent its     biomechanical behavior. Histological analysis appears inseparable from biomechanical     analysis.   "
57052|NCT02538809|"     Bladder cancer is a well-recognized complication in spinal cord injury (SCI) individuals. The     observed incidence rates in SCI individuals are considerably higher compared to the general     population. Bladder cancer in SCI individuals tends to present at an earlier age compared to     the general population. Furthermore, bladder cancer in SCI individuals is more commonly     invasive and at a more advanced stage at the time of diagnosis compared to bladder cancer in     the general population. Individuals with bladder cancer commonly present with hematuria and     other urinary symptoms. The gold standard for diagnosis is cystoscopy. However in SCI     individuals, hematuria may get attributed to catheter irritation or trauma or an urinary     tract infection. Furthermore, the bladder wall commonly presents with various changes under     cystoscopic examination masking the presence of a bladder wall mass. Thus, diagnosis of     bladder cancer in SCI individuals can be complicate.      Some cytokeratins are frequently overexpressed in tumor cells and are therefore a marker of     bladder cancer. There is a new commercial test available for the quantitative measurement of     cytokeratins. The diagnostic accuracy of this test has been investigated in non-SCI     individuals with symptoms suspicious for bladder cancer. The test showed high sensitivity and     specificity values and is thus a promising diagnostic or screening tool. However, the     diagnostic accuracy of the test has not yet been investigated in SCI individuals.      The primary objective of the proposed study is to investigate whether urine cytokeratin     levels in spinal cord injury individuals with symptoms and findings suspicious for bladder     cancer are a discriminator between individuals suffering from bladder cancer and those not     suffering from cancer.      Individuals presenting with symptoms suspicious of bladder cancer will undergo ultrasonic and     cystoscopic examination of the bladder. An urine sample will be taken, and the bladder will     be flushed for collecting a bladder fluid sample. In patients with bladder wall findings     suspicious of cancer, a bladder wall biopsy will be taken, according to clinical standard     practice. The bladder fluid and the bladder wall biopsy will be submitted for cytology and     histopathology examination, respectively. Cytokeratin levels will be measured in the urine     sample.   "
57053|NCT02538796|"     Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality)     that has changed little over in half a century. One of the forms is the restrictive anorexia     nervosa (ANR). It consists of a phobia of weight gain and food with a massive food     restriction. This pathology is studied in psychology but not using the theories of embodied     cognition in which perception and action interact through sensorimotor processes. They are     the source of attitudes (unconscious) towards certain stimuli and influence our     interpretation (conscious).   "
57054|NCT02538783|"     This study aims to evaluate the effectiveness of financial incentives in improving and     maintaining weight loss.   "
57056|NCT02538744|"     The investigators will assess the impact of treatment with doxazosin and modafinil, alone and     in combination, on the subjective and reinforcing effects of cocaine in     non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid     design in which participants will be randomized into two groups: placebo and doxazosin 8     mg/d. They will remain in their assigned group for the duration of the study. After titrating     doxazosin to the target dose, study procedures will be completed three times, once during     treatment with each dose of modafinil (0, 200, and 300 mg/d), in pseudo-random order such     that 200 mg precedes 300 mg).   "
57146|NCT02537548|"     This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in     treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in     the body behind the intestines that is typically the first place that seminoma spreads. RPLND     is a surgery that removes lymph nodes in this area to treat testicular seminoma and may     experience fewer long-term toxicities, such as a second cancer, cardiovascular disease,     metabolic syndrome (pre-diabetes), or lung disease.   "
57057|NCT02538731|"     Very large bile duct stones are difficult to remove. Dilation-assisted stone extraction, also     termed small endoscopic sphincterotomy plus endoscopic papillary large balloon dilatation, is     safe and effective technique for the treatment of large CBD stones. However, in approximately     5-10% of patients, the removal of large bile duct stones may be difficult. For this selected     group of patients for whom all conventional endoscopic stone treatment devices have failed,     laser lithotripsy technology has provided an approach to the fragmentation of difficult bile     duct stones.      A single-operator cholangioscopy (SOC) system (SpyGlass Direct Visualization System, Boston     Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy     limitations. The investigators aimed to evaluate the efficacy and safety of Spyglass-guided     laser lithotripsy for difficult CBD stones not amenable to conventional dilation-assisted     stone extraction therapy.   "
57058|NCT02538718|"     Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it     was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has     many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such     complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its     use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare     the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to     ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34     completed weeks whose uterine contraction is more than 4 during 20 minutes period with their     cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or     MgSO4 group. Then, the investigators will check the change of their interval of uterine     contraction, degree of pain and the appearance of any side effects or treatment failure sign.   "
57059|NCT02538705|"     The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in     the treatment of ulcers related to diabetic foot syndrome   "
57061|NCT02538679|"     Postoperative pain can pose significant challenges in the postoperative recovery of patients     undergoing major colorectal surgery. Traditionally, opioids have played an important role in     treating postoperative pain. It is well established that opioids are highly effective in     relieving pain; however opioids are associated with numerous side effects that include     nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus,     drowsiness, sedation, and allergic reaction. These opioid side effects, which range in     severity, can significantly interfere with discharge home following colorectal surgery.     Significant interest exists in the use of local anesthetic based regional anesthesia     techniques as a means to extend the analgesic window for patients undergoing colorectal     surgery. Specifically, the use of the TAP block as an adjunct in postoperative pain control     has been widely reported in the anesthesia and colorectal surgery literature. Historically,     the block was performed in a blind fashion with relative success and presently the block is     typically performed either with ultrasound guidance or laparoscopic visualization. While TAP     block has shown to be effective in post-operative pain control, the techniques used to place     the block have not formally been compared.      The investigators are purposing a prospective, patient-blinded, randomized study of patients     undergoing major colorectal surgery to compare TAP block under ultrasound guidance versus     laparoscopic visualization versus no TAP block. The investigators hypothesize that     laparoscopic-guided TAP block is non-inferior to ultrasound-guided TAP block with respect to     perioperative pain control and either technique is superior to no TAP. In addition the     investigators will measure procedural time, any adverse events related to the block, overall     postoperative analgesic requirement, analgesic duration, postoperative pain scores, length of     postoperative hospital stay, incidence of postoperative ileus, and overall patient     satisfaction between the three groups.   "
57063|NCT02538653|"     This study aimed at determining the 4-hours postprandial blood glucose and insulin responses     to the ingestion of cereal product differing by their SDS content.   "
57064|NCT02538640|"     This is a laboratory-based research study conducted in two parts. Open cross-over design. 2     test sessions per subject included in the study. It aims at determining the postprandial     blood glucose and insulin responses to the ingestion of cereal product differing by their SDS     content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.   "
57065|NCT02538627|"     This is a Phase 1 open-label, dose-escalation trial using 3+3 design, evaluating MM-151     co-administration with MM-121 at varying dose levels.   "
57066|NCT02538614|"     This study consists of 2 parts: Phase 1b and Phase 2. Phase 1b will evaluate the safety and     tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI     836826 in participants with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and     establish the maximum recommended Phase 2 combination dose (highRP2D) as well as an alternate     lower recommended Phase 2 combination dose (lowRP2D). Phase 2 will determine the rates of     complete response (CR) and of minimal residual disease (MRD) negativity with the combination     at the highRP2D and the lowRP2D in participants with R/R CLL.      The Phase 2 portion of this study will not occur.   "
57067|NCT02538601|"     The purpose of this study was to test the efficacy of a CBT-based smoking cessation treatment     enhanced with transdiagnostic skills for the management of anxiety and fear-based avoidance     behaviors (CBT-A) relative to a standard CBT-based smoking cessation treatment (CBT-S) for     smokers with elevated PTSD symptoms who were exposed to the 9/11 World Trade Center disaster.     The investigators hypothesized that the CBT-A treatment would yield more favorable outcomes     with regard to smoking abstinence as well as improvements in PTSD and respiratory symptoms     over a 6-month follow-up period.   "
57068|NCT02538588|"     Comparison between two modalities of nebulization.   "
57069|NCT02538575|"     The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a     prognostic factor for cystic fibrosis patients.   "
57070|NCT02538562|"     This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric     and gastroesophageal junction cancer as assessed by local laboratories in a real-life     setting. No investigational products will be provided or evaluated.   "
57107|NCT02538068|"     This study plans to learn more about psychosocial factors that contribute to adopting     physical activity. The goal of this study is to improve upon existing theories of behavior     change in order to help other people become more physically active.   "
57071|NCT02538549|"     Behavioral activation (BA) is a low cost, evidence-based intervention that can be effective     in treating depression and anxiety. We have developed a behavioural activation card game for     clients receiving treatment through the Crisis Team and Traditional Case Management (TCM) in     Kingston, ON. The game is designed to integrate behavioural activation tools into daily life     while receiving points for completion of the each Activity Challenge, which are divided into     4 areas (ACE4), with the goal to receive maximum amount of points in the timeframe of the     study. Using a Randomized Control Trial (RCT) design, participants (n=40) will be assigned to     one of two groups, with the intervention group receiving ACE4 and treatment as usual (TAU)     and the control group only receiving TAU. Assessments will be carried out upon entry to the     study and at the end of the intervention period (8 weeks). Assessments will be completed     using the WHODAS 2.0 (World Health Organization Disability Assessment Schedule), HADS (The     Hospital Anxiety and Depression Scale), and CORE (Clinical Outcome in Routine Evaluation). We     hypothesize that the treatment group receiving the ACE4 intervention will show improvement in     overall mental state. Analyses will be conducted using SPSSv16, an analysis of covariance and     t-test, and a binary logistic regression analysis will be used to investigate factors that     predict good outcomes. Results will be published in international journals and presented at     conferences with an aim towards being applied to clinics in Pakistan.   "
57072|NCT02538536|"     This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050     800 mg daily oral administration in 40 adult patients with IPF.   "
57073|NCT02538510|"     This phase I/II trial studies the side effects of pembrolizumab and vorinostat in treating     patients with squamous cell head and neck cancer or salivary gland cancer that has come back,     has spread to other places in the body and/or cannot be removed by surgery. Monoclonal     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and     spread. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving pembrolizumab together with vorinostat may be a better treatment for     head and neck cancer or salivary gland cancer.   "
57074|NCT02538497|"     The aim of this study is two-fold: 1) To study risk factors for the development of postpartum     depression, including cognitive factors (i.e., perseverative negative thinking and     interpretation of infant facial expressions), and other factors such as negative childhood     experiences, parental attachment, parental stress and previous psychopathology. 2)     Investigate the effect of The Newborn Behavioral Observation (NBO) as a universal prevention     intervention implemented at well-baby clinics in Tromsø with regard to parental mental     health, parent-infant interaction and child development.   "
57076|NCT02538471|"     Patients with metastatic breast cancer receiving at least one single agent chemotherapy and     demonstrating stable disease or disease progression at two consecutive clinical/radiological     assessments (at an interval of at least 2 weeks).      Transforming growth factor-beta (TGFΒ) blockade will enhance response of irradiated tumors     and improve the function of Dendritic and T cells. Patients will receive 300 mg/day of study     drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day     cycle). Radiation to a metastatic site will be delivered at a dose of 7.5 Gy, given     consecutively on days 1-3-5.   "
57077|NCT02538458|"     Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis     in infants.   "
57078|NCT02538445|"     Based on the theory of embodied cognition, which focuses on the influence of sensory and     motor processes on cognition, researchers propose to study the influence of the action on     memorization and inhibition in patients suffering from schizophrenia, using a directed     forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of     action verbs. The instruction to forget is given at the end of learning the first list (To     Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is     presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is     performed at the end. The action verbs had to be encoded using four conditions: action     performed, mimed, imagined action, action with a contextual word, reading the action verb     only. 48 schizophrenic patients were included in this study. Patients were randomized to have     10 participants per condition. 48 controls matched by age, gender, laterality and education     are also included and randomized in the same modality. This study aims to show that the     encoding of sensory-motor components, more than providing a context could improve the     inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation     cognitive.   "
57079|NCT02538432|"     This is a phase II trial of (RQ-07) in advanced solid tumors in prostate, breast or non-small     cell lung cancer.   "
57080|NCT02538419|"     The investigators will compare two alternatives designed to maximize adherence to continuous     positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support     administered in groups, versus individual education.   "
57081|NCT02538406|"     Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for     screening purposes to find any precancerous lesions (polyps) at an early stage. During the     colonoscopy the doctor will advance the colonoscope to the end of your colon and start     examining the colon for any polyps. Withdrawal time is the period of time the doctor spends     examining the colon. Doctors usually spend six minutes examining the colon after they reach     the end of the colon. Studies have showed that spending more withdrawal time detects more     lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in     examining the right side will increase the detection of polyps in the right side of the     colon. There will be no other changes in the procedural aspect of the colonoscopy.   "
57108|NCT02538055|"     As many as 75% of people with diabetes report chronic pain. While cognitive behavioral     therapy (CBT) improves pain and functioning in individuals with chronic pain, many rural and     underserved communities lack resources for such programs. The investigators tested the     hypothesis that a CBT-based program delivered by community health workers (CHW) can improve     quality of life in individuals with diabetes and chronic pain.   "
57147|NCT02537535|"     Cross-sectional observational study designed to identify and describe the care gap in     guideline-oriented low density lipoprotein cholesterol (LDL-C) management in Canadian     patients at high cardiovascular risk.   "
57082|NCT02538393|"     The primary objective of the study is to      • Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for     oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.      The secondary objectives of this study are to        -  Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for          oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x          100 mg) dose of sorafenib in fasted state        -  Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension          formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)        -  Evaluate the taste and palatability of sorafenib (both formulations)        -  Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy          male subjects   "
57083|NCT02538380|"     The purpose of this study is to compare EUS-B-FNA (using the EBUS scope)with EUS-FNA for left     adrenal gland analysis in lung cancer patients.   "
57084|NCT02538367|"     A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose,     parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation   "
57085|NCT02538354|"     This study will evaluate if suppelementation of the diet with riboflavin in Crohn's disease     patients will result in an increase in the amount of F. prausnitzii.   "
57086|NCT02538341|"     The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the     herpes zoster (shingles) vaccine, Zostavax, in patients over 50 years old with arthritis and     other diseases who are using anti-TNF therapy and who have not previously received the     vaccine.   "
57087|NCT02538328|"     Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery     especially in gastric bypass surgery patients.   "
57088|NCT02538315|"     While positron emission tomography/computed tomography (PET/CT) can assist in the diagnosis     of Parkinson disease (PD), it can also potentially help monitor treatment options for PD. One     such experimental therapeutic option for PD is fetal dopaminergic transplantation trials. A     potential goal of such novel therapies is to replace deficient dopaminergic neurons in PD.     Researchers at the University of Saskatchewan have been at the frontier of these exciting     treatment options. [18F]FDOPA PET/CT imaging has been successfully used by some authors to     monitor engraftment and assess efficacy of fetal dopaminergic transplant . This study also     aims to utilize [18F]FDOPA PET/CT imaging to potentially aid in detecting alterations in the     dopaminergic pathway from these innovative surgical treatment options.      There are two main objectives of this study: 1) Evaluate the effectiveness of fetal     dopaminergic grafts in patients with PD using FDOPA PET imaging pre and post-surgical     implantation and a secondary longer term goal 2) Correlate the [18F]FDOPA PET/CT findings in     early PD with post-mortem pathological analyses of PD   "
57091|NCT02538276|"     Cerebrovascular disease is a leading cause of death and the leading cause of serious     long-term disability. Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are     alternative strategies for stroke prevention in patients with atherosclerotic carotid     disease.The safety and efficacy of CAS compared to CEA still remains questioned, and CEA has     been considered to the first-line treatment of carotid stenosis in worldwide. The purpose of     this study is to compare the practice and outcomes of CAS and CEA in a real world setting at     Public University Hospitals in Brazil.   "
57092|NCT02538263|"     Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that targets a preseted tidal     volume (VT) by automated adjustment of pressure support, could guarantee the delivered VT     over pressure-limited noninvasive ventilation (PL-NIV) with fixed level pressure support.     Whether VT-NIV is more effective in improving gas exchange in patients with acute hypercapnic     respiratory failure (AHRF) as compared with PL-NIV remains unclear. Our aim was to verify     whether in comparison with PL-NIV, use of VT-NIV was more effective in correcting     hypercapnia, hence reducing the need for intubation and improving survival in patients with     AHRF.   "
57093|NCT02538250|"     Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study     is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show     that it is acceptable for patients in the United Kingdom.   "
57094|NCT02538237|"     Aim: Use an ibuprofen mouthwash 2% irrigate subgingival in improving the progression of     periodontal diseases can be evaluated. Materials and Methods: 22 patients with chronic     periodontitis without any systemic disease who have had periodontal disease, and 2 molars     that have periodontal pockets deeper than 4 mm on either side of the lower jaw have the     clinical examinations. Interventions: For patients who participated in this study, subjects     who received oral hygiene instruction and scaling root planing (SRP), After 2 weeks, They     were divided into two groups as determined by randomization in this study, Experimental     group: ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad     University, Tehran), Control group: placebo, Subgingival Irrigation of ibuprofen 2% mouthwash     with an insulin syringe 0.5 ml were rinsed, Clinical measurements including probing depth     (PD), clinical attachment levels (CAL), Plaque Index (PI), and Bleeding Index (BI) were     recorded and the patients were recalled per once every 2 weeks for 3 months is repetitive,     and at the end of 3 months, were evaluated changes in clinical periodontal parameters. ®   "
57120|NCT02537899|"     SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and     will provide important information on the feasibility of conducting larger controlled trials.   "
57148|NCT02537522|"     The objective of this study is to determine if corneal diameter and keratometry readings     correlate to subjective comfort and lens fitting characteristics.   "
57149|NCT02537509|"     Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D     supplementation or not, could be beneficial to improve disease LTC in AD patients   "
57095|NCT02538224|"     Objectives: The aim of the present clinical study was to evaluate the efficacy of doxycyline     3% plus ketoprofen 2.5% as an adjunct to scaling and root planing in the treatment of chronic     periodontitis(early-modearte). Material and Methods: 20 systemically healthy, chronic     periodontitis patients were included in the study.The Patients were selected on the basis of     having chronic periodontitis with periodontal pocket depths of more than 4mm on at least two     teeth in mandibular molar area; Periodontal parameters (plaque, bleeding on probing and     pocket depth) were recorded at baseline and every 15 days for 3 months. Oral hygiene     instructions were given that included brushing twice- daily, (Using the Bass brushing     technique for at least 2 minutes ), Randomly divided two groups,Test group: was treated by     scaling and root planing Followed by local delivery of doxycycline 3%+ ketoprofen 2.5%, While     the control group: was treated by scaling and root planing along with ketoprofen 2.5%; and     was administered to the both groups every 15 days for 3 months, repeated. Every 15 days once     periodontal parameters were assessed, and at the end of 3 months, evaluated the clinical     parameters changes.   "
57096|NCT02538211|"     The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus     vaccine immune responses in healthy adult volunteers.   "
57097|NCT02538198|"     This is a Phase 2 study to assess the good and bad effects of maintenance therapy on patients     who have been treated for myeloma and no longer show signs of this type of cancer.   "
57098|NCT02538185|"     The study is planned as a single-center, randomized, double-blind placebo-controlled,     comparative Phase I, first-in-man study to assess the safety and tolerability of the     NanoJect™ device, and the immunogenicity of the rabies vaccine Vaccin rabique Pasteur®     delivered with the NanoJect™ device by ID route.   "
57099|NCT02538172|"     An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in     D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV     assay. Investigators will include kidney and liver transplant recipients. Patients will be     randomized during the first month post transplant.      In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be     monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be     done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis     will depend on the result of the assay:        -  T-Track positive (patient at lower risk): discontinuation of the antiviral drug        -  T-Track negative (patient at higher risk): continuation of the antiviral drug until the          maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard          fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients          and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the          Quantiferon-CMV® assays will be done at the same time points of the interventional arm,          but the result will not be known by the investigators.      After discontinuation of prophylaxis, patients in both arms will be followed for the     development of CMV replication at each visit using the local PCR assay and antiviral therapy     will be administered in case of CMV infection according to local guidelines.      The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV     replication during the first 12 months post transplant AND the duration of antiviral     prophylaxis.   "
57100|NCT02538159|"     Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare     the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral     inserted central catheter.   "
57101|NCT02538146|"     An open label pilot study will determine the effect of the amino acid nutritional supplement     acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory     mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is     given to all participants for 3 months, and assessments will occur at intake and after 3     months.   "
57102|NCT02538133|"     Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is     often difficult (germs are found only in 50% of cases). Conventional imagery is often     non-specific and difficult to interpret especially in early postoperative phase. Leukocytes     isolated from the patient's blood are labeled with a radiopharmaceutical technetium     99mTc-HMPAO.      The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid     SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis     infection.   "
57103|NCT02538120|"     This study aims to see whether or not the diabetes 1 patients have a neurovascular     microcirculatory dysfunction using various microvascular tests which have been previously     validated.      Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in     Laser Speckle Perfusion Units (LSPU).   "
57104|NCT02538107|"     This observational study will investigate efficacy and safety of methoxy     polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each     participant will be collected over 15 months of Mircera therapy.   "
57105|NCT02538094|"     This research is being done to determine whether transcranial direct current stimulation     (tDCS) can improve certain mental abilities in individuals with multiple sclerosis or     encephalitis. Participants will be asked to come in daily for two full weeks during which     time they will undergo cognitive testing and Magnetic Resonance Imaging (MRI) brain scans. In     this research, a very weak electrical current is administered to the surface of the scalp     while participants complete cognitive tasks. The investigators' aim is to find out whether     tDCS will improve task performance in adults with multiple sclerosis or encephalitis.   "
57106|NCT02538081|"     This study proposes to conduct a clinical trial comparison of olanzapine and the combination     of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a     dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the     hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that     enhances the efficacy of olanzapine that allows its slight superiority to risperidone. This     trial would enroll patients taking olanzapine and record baseline measurements of clinical     symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects     would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6 weeks     and then would again have measurements of clinical symptoms, cognition, metabolic parameters     and extrapyramidal side effects.   "
57238|NCT02536352|"     The purpose of this study is to determine whether fluoride supplementation during pregnancy     is effective in extending the length of gestation and improving overall perinatal well-being.   "
57109|NCT02538042|"     The central objective of the project is to evaluate the effect of incorporating smoking     related contexts into very low nicotine content (VLNC) cigarette extinction trials on     clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking     (N=80) will be interviewed and trained to take pictures where they smoke cigarettes.     Following taking these pictures, participants will then be switched to smoke VLNCs while     wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period,     half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of     multiple context extinction (MCE+) during which they will view smoking-related environments     and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE     (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of     the three weeks, participants will quit smoking and continue to wear the nicotine patch while     being followed during a 10-week abstinence period. Participants will also complete a     follow-up phone call 6 months after their quit day.   "
57110|NCT02538029|"     The primary aim of the proposed project is to characterize dual tasking (DT) deficits to     improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's     disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15     individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation     Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion     capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural     control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of     these findings. This phase will involve creating a clinical intervention based on the     objective information gathered the CAREN system. The intervention will take place 3x/week for     a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2)     Single task group (N=10). Outcome measures will be used at the beginning and end of the     intervention to assess the feasibility and efficacy of the intervention.   "
57111|NCT02538016|"     The goal of this research project is to establish that in short-term use, tolvaptan is a safe     and potentially effective new therapy for cystinuria, by conducting a short-term pilot study     of the safety and tolerability of this drug, and assess impact on urinary stone risk     parameters, among adolescent and young adult patients with clinical cystinuria.   "
57112|NCT02538003|"     The purpose of this study is to assess safety, tolerability of LCB01-0371 after     fasting/non-fasting food taken in healthy male subjects.   "
57113|NCT02537990|"     The purposes of this study are: 1. To identify and quantify the health utilities and quality     of life experienced by patients who have been diagnosed with MDS and what are their     predictors. 2. Measure the effects of patient related factors like frailty and comorbidity on     quality of life and overall survival or toxicity to therapy. 3. Assess how quality of life     changes over time and what are its predictors. This will be valuable information that may     guide therapy, transfusion practices, etc., as MDS is a chronic, incurable disease that is     often progressive.   "
57114|NCT02537977|"     Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy     with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this     clinical trial, the investigators aim to assess the safety and efficacy of administering T     cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19     positive B cell malignancy including leukemia and lymphoma.   "
57115|NCT02537964|"     This is a prospective, controlled; crossover study of daily bathing with no-rinse, 2%     chlorhexidine gluconate (CHG) impregnated washcloths versus bathing with water/soap or water     according to gestational age and weight (e.g. standard bathing). The trial will take place in     the Neonatal intensive care unit (NICU).      Baseline data ragarding bloodstream infections (BSI) and colonization with multidrug     resistant orgnisms (MDRO) will be collected for 3-6 months prior to patient enrollment. In     the preliminary phase of the study we will establish the safety of chlorhexidine bathing     using Clinell ® Chlorhexidine wash cloths on three groups of patients: term infants admitted     to the NICU; late preterm infants (34-37 weeks); preterm infants 30-34 weeks of gestation.     Interim analysis for adverse events will be performed after each group of patients.      In the subsequent phases of the study, all infants admitted to the NICU and enrolled in the     study will be bathed three times a week with Chlorhexidine wash cloths during the initial     6-months study period (intervention), followed by standard bathing during the second 6-months     period, then again intervention period for 6 months and standard bathing for 6-months. Total     study period- 3 years.      Data collection will include all bloodstream infections as well as surveillance cultures   "
57116|NCT02537951|"     Small fiber neuropathy (SFN) is a common disorder, which has a profound negative impact on     quality of life because of severe neuropathic pain. To reliably establish a diagnosis of SFN     is challenging, since neurological examination and nerve conduction studies are often normal.     Autofluorescent flavoprotein imaging (AFI) is an optical method through which neuronal     activity in the termination area of small nerve fibers in the spinal cord can be quantified.     Since the epidermis also contains a high density of small nerve terminals and since the     number of intraepidermal nerve fibers is greatly reduced in patients with SFN, our hypothesis     is that AFI intensity is reduced in patients with SFN. To support this hypothesis, a pilot     study is required in which the investigators first need to confirm the precision of AFI in     the epidermis of the third finger of 10 healthy volunteers. Secondly, lidocaine/prilocaine     cream will be used as a negative control. Finally, the AFI signal will be measured after     application of a 8% capsaicin patch, through which (temporarily) a selective reduction of     small nerve fibers can be induced, mimicking SFN. Using this experimental design, the     investigators will be able to test the reliability and validity of AFI for capsaicin-induced     small nerve fiber degeneration. This would be a significant step in developing an objective,     rapid and non-invasive diagnostic tool to diagnose patients with SFN, which may also be     utilized as a biomarker in studies that assess the efficacy of novel treatments for SFN.   "
57117|NCT02537938|"     This study involves the use of an investigational drug called NGP 555. In each group of     healthy subjects, 2 people will receive placebo and 6 people will receive NGP 555.   "
57118|NCT02537925|"     The purpose of this study is to determine whether celecoxib is effective in the treatment of     nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.   "
57119|NCT02537912|"     The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose     was demonstrated in a double-blind, placebo-controlled study. .   "
57122|NCT02537873|"     The overall goal of this project is to develop initial human data on effects of novel     compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine     and self administration data) in non-treatment seeking cocaine use disorder subjects. The     compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR     agonists have been shown to reduce cocaine self-administration and cue reactivity in rodents.     In addition there is human safety data in non-cocaine using subjects for lorcaserin as it is     currently FDA approved for obesity, and safety data from a cocaine interaction study in     rodents , but there is no human cocaine interaction/PK data and no PD data to support     potential dosages for phase II clinical trials.   "
57123|NCT02537860|"     This prospective double-blinded clinical trial is intended to compare three nerve stimulator-     guided paravertebral block injections versus five injections for elderly patients undergoing     hernia repair regarding intraoperative hemodynamic stability and postoperative pain.   "
57124|NCT02537847|"     The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial     agents which can be used in outpatient for the treatment of non-bacteremic acute     pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was     conducted to compare the clinical and bacteriological outcomes of patients with     non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia     coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV     ertapenem.   "
57125|NCT02537834|"     An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and     efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.   "
57126|NCT02537821|"     Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in     severly burned patients. Potential HLA triggers in the treatment of severely burned patients     are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory     markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin)     and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in     severely burned patients.   "
57127|NCT02537808|"     The objective of this non-interventional study is to explore the safety, effectiveness and     quality of life of lenalidomide / dexamethasone as first line treatment for     transplant-ineligible patients with multiple myeloma in a real life setting.   "
57128|NCT02537795|"     In this study the investigators will use semi-structured interviews to qualitatively analyse     patient and family member experiences with either deep brain stimulation or other forms of     psychiatric neurosurgery.   "
57129|NCT02537782|"     Several attempts have been made to refine selection criteria for cardiac resynchronisation     therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously     proposed parameters probably do not sufficiently reflect the underlying mechanical     dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that     better candidate selection can rely on the direct observation or measurement of this LV     mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and     other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate     regional myocardial workload and metabolism, and determine their predictive value in CRT     response.   "
57130|NCT02537769|"     The use of implantable left ventricular assist devices (LVAD) has increased over the last     decade; partly because the newer continuous flow pumps feature a smaller design and better     durability. These pumps have shown improved outcomes for those patients who don't qualify for     heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart     transplantation. Despite these improved outcomes, procedure related length of hospitalization     for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One     important reason for this is that many people experience right ventricular dysfunction after     LVAD implantation. Treatment options for this are limited. Many LVAD patients with right     ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of     the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent     studies suggest that correction of the TV during LVAD implantation has improved survival for     those with severe regurgitation. However, this has not been evaluated for mild or moderate     regurgitation.      The goal of this study is to look at the clinical impact of surgical correction of mild to     moderate TR in participants who are also undergoing LVAD implantation. The study will look at     the degree of TR at various time points post-surgery, as well as any major cardiac adverse     events, duration of hospitalization, and quality of life. The investigators hope to show that     surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular     dysfunction and have a positive impact on health outcomes.   "
57131|NCT02537756|"     HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true     among traditionally underserved adolescents. Few parent-targeted interventions have focused     on the parental decision-making process. Self-persuasion, generating one's own arguments for     engaging in a behavior, may be an effective means to influence parents' motivation to     vaccinate their children. In a three-phase study, investigators are using quantitative and     qualitative research methods to develop and refine a tablet-based self-persuasion     intervention for parents who are undecided about the HPV vaccine. This clinical trial     submission focuses on the second phase of the study. The results of the second phase will     inform the third phase of the trial (also registered in clinical trials).   "
57132|NCT02537743|"     Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE     Renal Cell Carcinoma population   "
57133|NCT02537730|"     Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each     combination (lens / disinfecting cleaning system).   "
57150|NCT02537496|"     In this study the investigators aim at assessing and then enhancing neuroplasticity in the     dorsolateral prefrontal cortex (DLPFC) and working memory - a key function of DLPFC - in     patients with mild Alzheimer's disease (AD). The investigators will use Paired Associative     Stimulation (PAS) paradigm to measure neuroplasticity and then a 4-week course of     high-frequency repetitive Transcranial Magnetic Stimulation (rTMS) to the DLPFC to enhance     cognitive function. Clinical and cognitive assessments will be done at baseline, one week,     one month and 6 months after the rTMS course. Healthy controls will also be enrolled to carry     out baseline cognitive assessments and a baseline measurement of neuroplasticity.   "
57134|NCT02537704|"     Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico.     Several randomized controlled trials have shown that intensive lifestyle programs are     efficacious for the management of obesity. These programs include frequent sessions (14 or     more contacts in the first 6 months) focused on diet and physical activity and use a behavior     change protocol. In Mexico most primary care clinics and public hospitals apply traditional     treatments for obesity management, which have limited effect on weight loss. This study would     provide scientific evidence for an effective model for obesity management. Objective. The     purpose of this study is to evaluate the effectiveness of the Group Lifestyle Balance     Program for overweight and obesity management in adults, in primary care clinics and public     hospitals from Sonora. This is a translational clinical study. Healthcare providers from the     participating clinics will be trained with the Group Lifestyle Balance Program before its     implementation. The primary outcome measurement is the change in body weight from baseline to     6 months and 12 months. Changes in body mass index, waist circumference, systolic and     diastolic blood pressure, depression, quality of life and stress scales will be measured in     patients receiving the program before and 6 and 12 months after starting the program.     Additionally, biochemical parameters (fasting glucose, total cholesterol, LDL-cholesterol,     HDL-cholesterol, triglycerides, fasting insulin, Homeostatic Model Assessment- Insulin     Resistance (HOMA-IR) and liver enzymes [Aspartate transaminase (AST), Alanine     Aminotransferase (ALT)] will be evaluated from baseline to 12 months.   "
57135|NCT02537691|"     Prospective, single-arm, longitudinal, international, multicenter study in a real-world     cohort of adult severe asthma participants being conducted to assess the relationships     between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.   "
57136|NCT02537678|"     Children who are exposed to traumatic events are at risk for developing PTSD and other mental     health problems. Although effective treatments for childhood PTSD exist, service delivery     approaches that are more accessible, efficient, and cost-effective are needed to improve     access to evidence-based treatment. The proposed study furthers our pilot work and evaluates     an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize     treatment in community settings and improve the value and efficiency of trauma-focused     treatment for children compared to existing approaches, thereby reducing childhood PTSD and     related societal impacts and costs.   "
57137|NCT02537665|"     To explore the effect of heating precondition of epidural catheter on the incidence of injury     to blood vessel during epidural catheter placement.   "
57161|NCT02537353|"     The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding     located proximal to the angle of Treitz, whose cause is not related to esophagogastric     varices or gastropathy of portal hypertension.      Animal studies showed no absorption in the GIT and disposal within 48 hours of application,     and no reported cases of obstruction. Recently, a prospective study involving 20 patients     with upper gastrointestinal bleeding, showed that the application of hemospray ® promoted     hemostasis in 95% of cases, confirmed by endoscopic revision 72h after application without     any complication.   "
58651|NCT02517879|"     All households in three zones in Zambia's Eastern Province were invited to attend a community     point distribution of insecticide treated bed nets (ITNs). Households were then randomized to     different intervals for a community health worker (CHW) hang-up visit.   "
57138|NCT02537652|"     Individuals who experience a stroke or transient ischaemic attack (TIA) are at heightened     risk of subsequent vascular events, including heart attacks and secondary stroke/TIA. Blood     pressure control is considered the most important contributor to positive health outcomes in     stroke patients. The measurement of central blood pressure (cSBP) (the blood pressure which     is being exerted at the heart), may provide clinicians with important diagnostic and     prognostic information over and above that typically obtained from a peripheral blood     pressure measure (the blood pressure in the arm). Central blood pressures may be better than     traditional peripheral blood pressure measures as: i) peripheral blood pressure may not     accurately reflect the effects of peak arterial blood pressure on centrally located organs,     ii) central blood pressures may be 50 % superior to peripheral blood pressures when     predicting cardiovascular events, and iii) information pertaining to central blood pressures     may be more effective in the management of hypertension. While the validity of oscillometric     devices which measure central blood pressures has been demonstrated, further study is     required to determine precision under normal clinical operating conditions (i.e., reflective     of the Hospital/GP practice setting). As such, this study will assess central and peripheral     blood pressures of stroke patients when fasted and nonfasted, and when seated and supine. The     study is interested in identifying the effect of the above parameters (fasted vs. unfasted,     seated vs. supine) on central and peripheral blood pressures in stroke patients.      Participants will take part in three separate assessment sessions, on three separate days,     with a minimum 24 hour recovery between each session. Each assessment is expected to last 90     minutes, with a minimum of eight blood pressures being taken from the left upper arm. As     such, participants will be asked to give up 4.5 hours of their time to the study. During each     assessment participants will be tested in a fasted and non-fasted state, and in a supine     (lying) and seated position. All assessments will take place between 7 and 10am and will be     undertaken following written informed consent.   "
57139|NCT02537639|"     The investigators would like to evaluate how well intensive care trainees without previous     experience in transesophageal echocardiography are able to perform a transesophageal     echocardiography study in the clinical setting after completing a simulator based training     compared to conventional training.   "
57140|NCT02537626|"     This study evaluates the effect of applying low level laser light therapy to individuals with     mild to moderate Alzheimer's disease to see if it may improve their memory, thinking and     behaviors. Half of the participants will receive the real treatment with the laser device and     the other half of the participants will receive a placebo treatment (not active laser).   "
57141|NCT02537613|"     This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as     a possible treatment for Chronic Lymphocytic Leukemia (CLL).   "
57142|NCT02537600|"     The purpose of this study is to determine wether cobimetinib + vemurafenib combination     treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain     metastasis   "
57143|NCT02537587|"     The purpose of this study was to determine the effect of changing the amounts of resistant     starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy     bars. The investigators also compared the glucose and insulin responses to the rates at which     the food bars were digested in-vitro (in the test tube). The investigators thought increasing     resistant starch and reducing sugar would reduce the glucose and insulin responses, and that     adding protein would reduce glucose and increase insulin. The investigators also thought the     glucose and insulin responses in people would be related to the rate of digestion of the food     bars in-vitro.   "
57144|NCT02537574|"     This study will evaluate the safety, effectiveness and tolerance of low doses of oral     naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection     of VIVITROL.   "
57145|NCT02537561|"     In this proposed study the investigators will combine gemcitabine and cisplatin with     talazoparib to determine the recommended Phase 2 dose (RP2D) of this combination regimen.     After determination of the RP2D patients with lung cancer whose tumors carry molecular     alterations in DNA repair pathway genes will be enrolled to an expansion cohort to determine     anti-tumor efficacy. Tissue samples of patients with confirmed partial response, complete     response, and non-responders will be obtained for whole exome, and transcriptome sequencing     to characterize the genetic alterations associated with response to therapy.   "
57151|NCT02537483|"     The primary objective of this study is to compare the efficacy, safety, and tolerability of     IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects     with moderate to severe acne vulgaris.   "
57155|NCT02537431|"     UX023-CL304 is a Phase 3 open-label, single-arm, multicenter study to establish the effects     of KRN23 on bone quality and osteomalacia associated with XLH. Approximately 14 adult     subjects with a diagnosis of XLH supported by typical clinical and biochemical features and     who have not received oral phosphate and vitamin D therapy in the past two years will be     enrolled. Iliac crest bone biopsies will be performed at baseline and end of study. Baseline     histologic and histomorphometric assessments of the bone biopsy specimens will be performed     as each biopsy is completed to assess sample quality and confirm the presence of osteomalacia     in at least 8 subjects.   "
57156|NCT02537418|"     The purpose of this study is to find the highest dose of durvalumab or of durvalumab with     tremelimumab that can be tolerated without causing very severe side effects when receiving     standard chemotherapy and to see what effects the study drugs has on this type of cancer.     Patients may receive durvalumab alone or in combination with tremelimumab.   "
57157|NCT02537405|"     The objectives of this study are to establish the bioequivalence between rivaroxaban tablet     10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of     rivaroxaban 10mg in healthy adult male subjects.   "
57158|NCT02537392|"     The purpose of this study is to determine whether daily oral supplements of vitamin B complex     along with folic acid or supplements of iron plus folic acid given to women during     peri-conception can reduce the risk of congenital heart disease when compared with folic acid     alone.   "
57159|NCT02537379|"     This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF)     administered in combination with Copegus® tablets (ribavirin, COPE) will evaluate the safety     and efficacy of SOF administered in combination with ribavirin under real world use in Japan.     Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated     with SOF+ribavirin in routine clinical use, the primary objective of this study is to     evaluate the incidence of adverse drug reactions (ADRs) under real world settings.   "
57160|NCT02537366|"     Crossover randomized controlled double blinded trial :        -  The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes)          with dexmedetomidine (DEX) or placebo.        -  Secondary endpoints will be the sedation level as assessed by the Richmond Agitation          Sedation Scale (RASS), the number of interventions to allow the completion of NIV          session, the pain intensity level as assessed by visual analogue scale, the morphine and          ketamine consumption during NIV sessions, the comparison of blood gas measurements          before and after NIV sessions, the reproducibility of NIV cycles. The side effects of          DEX will be notified.   "
57163|NCT02537327|"     The aim of this study is to determine the incidence of recurrent caries around the different     types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better     characterize recurrent caries lesions in terms of location and size of the lesions and type,     material and age of the restoration.   "
57164|NCT02537314|"     The overall hypothesis of this proposal is that nutrient sensing in the foregut regulates     metabolic hormone secretion and nutrient metabolism via enteric neural signals, and these     mechanisms might be defective in obesity.   "
57165|NCT02537301|"     Group chat through the platform of mobile social networking provides an easily accessible,     real-time and interactive channel for communication. With the help of mobile social app, a     group of doctors with similar interests can share valuable cases, important papers and     opinions through multiple media types (texts, images, and videos). It remains unknown what     activities of Endoscopic Retrograde Cholangiopancreatography(ERCP) doctors on a group-chat     platform are.      In the beginning of 2013, a chatting group on Wechat (the most popular mobile social app in     China), focusing on ERCP, was created. All the doctors who received and finished their ERCP     training in Xijing Hospital of Digestive Diseases were invited to join in the platform. The     contents in the chatting group were analyzed. The relationships between the chatting     activities of ERCP doctors and the performance of ERCP (such as case volume, cannulation     success rate and PEP etc.) were investigated.   "
57166|NCT02537288|"     The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon     dose administration relative to placebo in healthy adult male and female subjects.   "
57167|NCT02537275|"     Investigators planned to investigate changes in visual function after wearing decorative     tinted soft contact lenses with different pigment-free optical zone diameters.   "
57168|NCT02537262|"     Preoperative midnight NPO is a traditional method for preventing aspiration during general     anesthesia. However, recent studies reported that drinking carbohydrate beverage, three hours     prior the surgery helps reducing patients starving, uncomfortment, and fatigue without other     complication. QOR 40 is developed for evaluating patients' recovery condition regarding     physical, psychological, and social aspects. Enhanced Recovery After Surgery(ERAS) is a     concept for reducing patients' hospital stay and helping recovery. Studies showed that     drinking carbohydrate beverage made better recovery of bowel function and shorter hospital     stay in colorectal surgeries. However, the effect of carbohydrate drink for laparoscopic     surgery is not yet proved. Therefore, the investigators will show the effect of carbohydrate     drinking through this study.   "
57239|NCT02536339|"     This study will examine the safety and efficacy of pertuzumab in combination with high-dose     trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease     progression in the brain following radiotherapy.   "
57240|NCT02536326|"     The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of     resistant hypertension in Chinese patients in a prospective cohort study.   "
57169|NCT02537249|"     Dexmedetomidine is a selective α2 adrenergic agonist that can be considered analgesics,     anxiolytic,and anti-stress effect . This randomized, double-blind placebo-controlled trial of     intraoperative dexmedetomidine for improvement of quality of recovery and analgesia from     surgery. Patients scheduled to undergo video-assisted thoracoscopic surgery (VATS) will be     enrolled. Patients will be recruited before the date of their surgery and will complete the     Quality of Recovery-40 (QoR-40) questionnaire before their surgery and at 24 and 48 hours     post op. They will also complete clinically significant pains score and oxygenation from the     postanesthetic recovery unit (PACU).   "
57170|NCT02537236|"     The positive patients to the Human Immunodeficiency Virus (HIV) with Highly Active     Antiretroviral Therapy (HAART) present multiple alterations in their corporal composition and     dyslipidemia, wich increase the cardiovascular risk.      The investigators evaluated the efficiency of the combination of fish oil omega 3 fatty acids     to different doses with the Therapeutic Lifestyle Changes (TLC) diet of the National     Cholesterol Education Program on the profile of lipids and the corporal weight in patients     with HIV treated with HAART.   "
57171|NCT02537223|"     This is a phase 1 study (the first step in testing a new drug or combination, to see how safe     the drug and/or combination are) of investigational agent BYL719 in patients with locally     advanced head and neck cancer (LA-SCCHN) in combination with standard radiation and     chemotherapy (cisplatin).      BYL719 is a new drug that is able to bind (attach to) and block a protein called PI3K-alpha.     PI3K-alpha is part of an important pathway called EGFR/PI3K/Akt. A pathway is a series of     chemical reactions among proteins in the cells that are involved in the support of normal     cellular function. If the pathway is too active, due to changes in those proteins, the     pathway can lead to tumor cell growth, survival and invasion. BYL719 has been shown to stop     cancers in laboratory and animal studies.      This study is the first time BYL719 will be combined with radiation and chemotherapy.   "
57172|NCT02537210|"     The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely     withdrawn in patients with long-standing clinical inactive UC.   "
57173|NCT02537197|"     This study examines the effect of regular naltrexone dosing on disordered gamblers. Gamblers     will also be scanned pre- and post-treatment where we will investigate the functional changes     to tasks designed to engage brain region associated with gambling and addiction. These     changes will be correlated with treatment outcomes and urge scores.   "
57198|NCT02536872|"     The concept of organisms living on or in the human body without causing overt signs of an     infection is common in medicine and has been termed a microbiome. Urine from patients with     Overactive bladder (OAB) grows different organisms from controls without OAB. However, it is     not known if the bacteria that have been identified are innocent commensals or pathogenic     organism responsible for the symptoms of OAB. Previous data suggests that treatment with     antibiotics does lead to an improvement in overactive bladder symptoms in a large number of     patients. On this basis the investigators now treat are patients with similar antibiotic     regimes. If antibiotics improve symptoms it would be expected that they would return the     microbiome back to how it is in patients without OAB. This study aims to identify the effects     of antibiotics on the urinary microbiome and to identify/confirm if antibiotic treatments     cause improvement in OAB.   "
58652|NCT02517866|"     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil     (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.   "
57174|NCT02537184|"     Objectives: To assess the beneficial and harmful effects of two recall intervals on caries     incidence (primary outcome) in preschool children with high caries risk. The level of     anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)     according to each interval will also be assessed. Methods: The sample will consist of 224     children between 3-5 years of age, of both genders, with high caries risk according to the     clinical criteria adapted from the Municipal Health Secretary of São Paulo. Children will be     randomly allocated into two study groups: Group 1 (G1) - oral clinical examination +     orientation for oral health and diet in return for 4 months; and Group 2 (G2) - oral clinical     examination + orientation for oral health and diet in return for 8 months. An examiner     calibrated and blinded to the study groups and the secondary outcomes will perform the     clinical examinations, which consist of: gingival bleeding index, dental plaque index,     detection of caries and its activity according to the ICDAS (International Caries Detection     and Assessment System) and the clinical features of active and inactive caries lesions will     be associated with the criteria discribed in ICDAS Commitee manual. An external dentist will     conduct the assessment of the anxiety levels assessed by the Facial Image Scale, the OHRQoL     measured by B-ECOHIS, the time and costs. All groups will be followed for an initial period     of 16 months, totaling four follow-up visits for G1 and two follow-up visits to the G2. All     analyzes will be performed by intention to treat (ITT) and considering the sensitivity     analysis to assess the differences between the ITT analyzes and analyzes of complete cases.   "
57175|NCT02537171|"     The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic     adenocarcinoma of stomach or gastroesophageal junction.   "
57176|NCT02537158|"     This study is a prospective non-randomized controlled study. The purpose of this study is to     evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization     (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after     radical surgery.   "
57177|NCT02537145|"     The aim of this pilot study is to determine the feasibility of Do-It-Yourself studies in     pregnant women to detect changes in health parameters by assessing compliance and user     experiences of participants. Besides, the measured health will be analysed to increase     insight in physiological development in pregnant women.   "
57178|NCT02537132|"     The purpose of this study is to demonstrate that the adaptation to the Non Invasive     Ventilation (NIV) at home is not worse when compared with an adaptation performed in     inpatient settings.   "
57179|NCT02537119|"     Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with     nonspecific low back pain.   "
57180|NCT02537106|"     Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and     microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and     natriuresis is less pronounced.   "
57191|NCT02536963|"     Amblyopia (lazy eye) and strabismus (misaligned eyes) are medical eye conditions that     combine as the leading causes of preventable vision loss in children. They are irreversible     if not detected and corrected by the age of seven, however half of all cases are missed     because the conditions do not always manifest themselves and pediatricians are unable to     reliably detect the conditions. The current health care system badly needs an accurate and     effective approach toward detecting amblyopia and strabismus in preschool children.      The study will be conducted in busy, ethnically and racially diverse primary care sites     operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric     Vision Scanner with outcomes the current standard of care.   "
57192|NCT02536950|"     This is an open-label, non-randomized, pilot study to determine the safety and feasibility of     the insulin-only bionic pancreas.   "
57413|NCT02534064|"     The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+     pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the     serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women.   "
57181|NCT02537093|"     Specific Aims: This study aims to assess the acceptability of asynchronous      telepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility (SNF)      population, in a 12-month randomized controlled trial. ATP relies on video recording of a      psychiatric interview, where the video is later reviewed by a psychiatrist to make a      psychiatric diagnosis and treatment recommendation to the primary treatment team.      STP is real-time, face-to-face psychiatric assessment using video conferencing to come      up with a psychiatric recommendation. People residing in SNFs generally rely on primary      and consultant physicians to visit them and rarely have outpatient psychiatrist follow-up.      SNFs offer more services than what is available to primary care office, and include 24-      hours skilled nursing services, physical therapy, nutritional consultation, occupational      therapy, social services, wound care, and psychiatric consultation when available. SNF      residents are unable to live independently due to their multiple medical comorbidities      and are therefore more medically ill than patients who are typically seen in primary care      settings. The present study aims to demonstrate feasibility and to collect pilot data in      SNFs. This study is funded by the UC Davis Behavior Health Center of Excellence grant      via the California Mental Health Services Act (Prop 63). In a larger, future study, the     investigators      intend to demonstrate that ATP will be no different than STP in clinical outcomes but will      be more accessible and cost effective.   "
57182|NCT02537080|"     The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through     the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral     blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly inhibited     the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of nitric oxide     and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal cytokine networks     are important in the development of nerve cell damage that leads to cognitive impairment.   "
57183|NCT02537067|"     The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus     Chondrocyte) in patients with cartilage defects in their ankle for 18 months   "
57184|NCT02537054|"     The purpose of this study is to determine whether Aflibercept (Eylea) is effective in the     treatment of choroidal neovascularization and fibrovascular proliferation in patients with     pseudoxanthoma elasticum (PXE) in terms of preservation or improvement of visual acuity.   "
57185|NCT02537041|"     SITUATION ON RESEARCH Diastolic heart failure (HF) or heart failure with preserved systolic     function (SF) is the primary cause of heart failure in the elderly (over 2/3 of heart failure     in patients over 60 years). Its main cause is hypertension. The diagnosis of diastolic heart     failure is still controversial in clinical practice. It is based on ultrasound and biological     criteria (or MRI). Basically, it is concerned patients making acute pulmonary edema with     preserved SF and high BNP. It is now recognized that the primum movens of this type of HF     is increased myocardial stiffness secondary to LVH. Noninvasive assessment of this parameter     would allow a more accurate and reliable diagnosis because not dependent on load conditions     unlike the ejection fraction (EF) and trans-mitral Doppler. However, the absence of     non-invasive tool for the direct evaluation of the diastolic stiffness (so-called passive)     prevents to date to use this diagnostic parameter.      The investigators propose here to evaluate noninvasively myocardial stiffness in elderly     patients with diastolic heart failure using a new imaging tool that uses an innovative     ultrasonic technology, the ultrafast echo associated with its elastography function     ShearWave Imaging (SWI). The investigators work for several years in collaboration with the     Langevin Institute on this technology which was recently validated in experimental models.     Its principle is based on the creation of a shear wave from a standard ultrasound and     calculating the velocity of this wave with the high time resolution of the ultrasound probe,     this being correlated with the speed myocardial stiffness.      The human study was recently made possible by the development of a phased array probe having     the opportunity to work with elastography mode (SWI).      PURPOSE OF RESEARCH The goal will be to demonstrate the interest of the non-invasive     evaluation by ultrafast echo (SWI) of myocardial stiffness in the diagnosis of diastolic     heart failure in the elderly.   "
57186|NCT02537028|"     The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to     evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C     administered for 4 weeks in systemic lupus erythematosus subjects (SLE).   "
57187|NCT02537015|"     This study evaluates the long-term (9-months) safety of the Bimatoprost Ocular Insert in     subjects with Glaucoma or Ocular Hypertension. All the subjects will receive Bimatoprost     Ocular Insert and will wear it for approximately 3 months (12 weeks), then will have a that     Insert removed and a new Insert placed for another 24 weeks (approximately 6 months).   "
57188|NCT02537002|"     The purpose of this study is the following:        -  To determine the safety and tolerability of single ascending intravenous (IV) doses of          PF-05230907 in healthy Japanese subjects.        -  To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy          Japanese subjects.        -  To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy          Japanese subjects.        -  To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects   "
57189|NCT02536989|"     The investigators will include those patients with adherent clot on gastric or duodenal     ulcers after endoscopic confirmation After receiving well explanation and giving written     consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first     group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second     group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients     in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd     for further treatment of peptic ulcer.      The investigators define rebleeding during admission and within 30 days as primary end points     and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization     days after allocation as secondary end points.   "
57190|NCT02536976|"     There is a high prevalence of OAB symptoms among patients with Parkinson's disease and a lack     of pharmacotherapies with an acceptable side effect profile. Specifically, available     anticholinergic medications have a high risk of cognitive side-effects, which preclude their     use in PD patients with CI. PD can also cause a number of non-motor symptoms that are likely     to be adversely affected by the currently available anticholinergic agents. Mirabegron is the     first pharmacologic treatment which may not exacerbate CI, constipation, orthostatic     hypotension (OH), somnolence, and dry mouth in PD.   "
57193|NCT02536937|"     Primary Objective:      To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics     (PK) of eliglustat.      Secondary Objective:      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with     mild, moderate, and severe renal impairment in comparison with matched subjects with normal     renal function.   "
61116|NCT02485600|"     This is an open-label, postmarketing, observational study to document health outcomes, in     Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa     (levodopa/carbidopa intestinal gel).   "
57194|NCT02536924|"     Crisis Teams are now a well established part of the mental health system. These teams are     effective in providing crisis management, treatment, referral, and educational services. We     are testing a waiting room intervention for the patients attending a Crisis Team. As far as     we are aware, no trial of a waiting room intervention has been reported in a psychiatric     setting. This is a preliminary study using a Randomized Control Trial (RCT) Design. Patients     (N =40) will be randomly allocated to either the treatment or the control group, and will be     selected from the local Crisis Team. The treatment group will receive a waiting room     intervention called, RESOLVE (Relaxation, SOLving problem and cognitiVe Errors), that is a     short film, Plus Treatment As Usual (TAU), and the control group will receive only TAU.     Patients in both groups will be assessed before and after the intervention, using the HADS     (Hospital Anxiety And Depression Scale), CORE (Clinical Outcome in Routine Evaluation), (to     measure psychopathology) and WHODAS (World Health Organization Disability Assessment     Schedule) (for functioning). We hypothesize that the treatment group will demonstrate     significant improvement in mental health and functioning, compared to the control group.     Analyses will be conducted using SPSS v22, and will consist of a t-test or Chi Square test to     measure the baseline differences, and a linear regression to compare the differences between     the two groups at the end of the intervention. Results will be published in international     journals and will be presented in local and international conferences.   "
57195|NCT02536911|"     Primary Objective:      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of     eliglustat.      Secondary Objective:      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with     mild and moderate hepatic impairment in comparison with matched subjects with normal hepatic     function.   "
57196|NCT02536898|"     The main aim is to assess the effectiveness of introducing a standardized intervention     program for treatment of fracture patients as measured by changes in the fracture rates and     the mortality.   "
57197|NCT02536885|"     Permanent and temporary cognitive impairment in the perioperative period is of great     importance to patients. Hypoperfusion due to the intraoperative hypotension is often     mentioned as a possible cause of postoperative cognitive dysfunction.   "
57199|NCT02536859|"     This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the     effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial     drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at     steady-state conditions in subjects with type 1 diabetes mellitus.   "
57200|NCT02536846|"     The primary aim of this study is to investigate antipsychotic drug effects on healthy brain     metabolism.   "
57201|NCT02536833|"     The purpose of this study is to assess the efficacy, safety, and tolerability of three     different strengths of SM04690 injected in the target knee joint of moderately to severely     symptomatic osteoarthritis subjects.   "
57202|NCT02536820|"     The Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the     interactions between the processes of adaptive behavior, neurological, endocrine and immune.      Among its premises assuming homeostasis or physiological balance as an integrated process     involving the systems above mentioned.      Additionally, among the basics theme the re-mean is introduced, ie changing the direction,     the function of a concept from a negative context carry a positive meaning, so that from the     PNIT no disease is seen as a problem but as a situation to solve. The patient then transmits     the importance of which will come.      Primary objective:      To investigate whether patients on PNIT have a higher proportion of patients achieving     disease control (<7% in glycosylated hemoglobin (HBAC1) and quality of life compared with     conventional treatment patients.      Methodology:      quasi-experimental, simple blind, simple blind, parallel, phase III clinical trial The     investigators will follow a group of patients with type 2 diabetes mellitus durgin three     months with an interim analysis a month after receiving the intervention (two visits) During     each visit a trained PNIT physician assess the effectiveness, safety and quality of life of     each patient.      The investigators will include male or female patients aged 18 years-old with diabetes     mellitus type II in any severity, uncontrolled (> 7% Glycosilated Haemoglobin (HbAc1)) and     any treatment regimen included.      The patients are not allocated by a random process and the investigators will have a     convenience sample      The investigators will perform an intention to treat analysis, patients will be analyzed     according to the intervention received even if this was different from the one they were     assigned.   "
57203|NCT02536807|"     Open gingival embrasures, also called black triangles, may occur after surgical     intervention or tooth replacement by an implant. They are perceived as anaesthetic by most     patients and causing functional and phonetic problems. The aim of the present study is to     assess the effect of injection of hyaluronic acid for papilla augmentation next to an implant     restoration in a clinical controlled double-blinded randomized trial with 6 months follow-up.   "
57204|NCT02536794|"     The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in     combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both     MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight     infections and cancers). MEDI4736 attaches to a protein in tumors called PD-L1. It may     prevent cancer growth by helping certain blood cells of the immune system get rid of the     tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting     a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may     result in better treatment options for patients with breast cancer.   "
57206|NCT02536768|"     NOTE THAT THE STUDY IS LED BY SOUTH AFRICA NATIONAL DEPARTMENT OF HEALTH AND WORLD BANK WITH     SUPPORT FROM BOSTON UNIVERSITY. The South Africa National Department of Health (NDOH) intends     to launch its newly developed National Adherence Guidelines for Chronic Diseases (HIV, TB and     NCDs) throughout South Africa in the coming year. Early implementation of the minimum     package of interventions described in the Adherence Guidelines for HIV patients will take     place at 12 primary health clinics and community health centres in four provinces starting in     July 2015. To maximize the learning potential of this early implementation stage, NDOH will     match the intervention clinics with 12 comparison clinics and randomly allocate intervention     or comparison status within the pairs of clinics. This will allow the outcomes of the     interventions to be evaluated using a cluster-randomized design and generate data on the     costs of implementation and the potential need for adherence support for the other diseases     addressed in the guidelines (tuberculosis, hypertension, and diabetes). This protocol is for     the evaluation, which will generate information on the effectiveness of minimum package     interventions and help improve the design, implementation, and budgeting of the guidelines.   "
57207|NCT02536755|"     Primary Objective:      Evaluate long term skeletal response to eliglustat in adult patients who successfully     completed the Phase 2 or Phase 3 studies.      Secondary Objective:      Evaluate the safety of eliglustat in adult patients who successfully completed the Phase 2 or     Phase 3 studies.   "
57208|NCT02536742|"     This international, multicenter, prospective single arm Phase II biomarker discovery clinical     trial with the primary objective of assessing the association of PFS with gene mutations,     gene copy number aberrations and gene signatures in post-menopausal women with hormone     receptor positive, HER2-negative metastatic or locally relapsed breast cancer whose disease     has progressed after prior adjuvant endocrine therapy or one line systemic treatment, i.e.,     endocrine treatment or chemotherapy, administered for metastatic disease.   "
57209|NCT02536729|"     Objective: The primary objective of this study is to assess the quality of life of people     treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging     procedures, according to the outcome variables reported by patients.      Type of study: A non-interventional observational analytic prospective cohort study.      Sample: We will include people who need bowel cleansing for the realization of imaging tests      Exposures: - oral sodium phosphate normal regimen        -  Oral sodium phosphate with modified diet        -  Polyethylene Glycol + electrolytes      Follow-up time: 8 days after the bowel preparation      Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium,     Potassium, Calcium)   "
57210|NCT02536716|"     To compare platform-switched implants to platform-matched implants for replacement of a     single missing tooth and their effect on: 1) Interproximal alveolar crest level in relation     to implant platform. 2) Buccal implant recession. 3) Presence or absence of black triangle     apical to the contact point. 4) Implant Success. 5) Adequate buccal tissue thickness.   "
57211|NCT02536703|"     To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for     Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic     stenosis.   "
57212|NCT02536690|"     Propofol in combination with remifentanil or midazolam can result in synergistic or additive     effect.      The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120     patients will be randomly allocated to 3 groups(P, PR, PMR). The patients in group P will     receive general anesthesia only with propofol and group PR and PMR will receive 0.25     mcg/kg/min remifentanil infusion prior to propofol. The patients in group PMR will receive     0.03 mg/kg bolus dose of midazolam 1 min after start of the remifentanil infusion. 'Success'     is defined as loss of both verbal response and eyelash reflex in 2 min after propofol     administration. When 'success', the next patient will receive the same dose(in 18/19     probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the     next patient will receive 0.25 mg/kg higher dose of propofol at induction period.   "
57213|NCT02536677|"     EMPACT is the first attempt to comprehensively evaluate the current emergency care of acute     chest pain from a regional representative sample in China.Findings will allow new     opportunities to facilitate the clinical quality improvements and ultimately reduce the     mortality and health care burden in patients with acute chest pain. It also will help to     establish a regional network and database for further research and performance improvement.   "
57214|NCT02536664|"     It is a non-interventional study with a duration of approximately 24 months per participant     to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab     maintenance therapy in daily routine in participants with previously untreated, relapsed or     refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical     practice.   "
57215|NCT02536651|"     There are no validated patient-reported outcome measures to assess lower extremity function     in Finnish language. The present study aimed to 1)translate and culturally validate the     Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity     Functional Scale, and 2) study the psychometric properties of these two questionnaires   "
57216|NCT02536638|"     The purpose of this research study is to compare the amount of protein excreted by the     kidneys in a 24-hour period between patients who have a kidney infection and those who do not     have a kidney infection.   "
57217|NCT02536625|"     NK (Natural Killer) cells are important in the fight against tumor, especially for the     control of cancer metastasis. The purpose of this prospective study is to evaluate the impact     on lymphocytes NK functions and development of an everolimus treatment in women treated for a     metastatic breast cancer. In particular, the study of lymphocytes NK functions and     development under everolimus treatment could permit to validate an early biomarker of the     impact of everolimus on these NK cells.   "
57218|NCT02536612|"     The purpose of the study is to test feasibility and acceptability of a lottery to help women     in Cape Town, South Africa to continue using long-acting reversible contraceptives to avoid     unintended pregnancies, and to also use condoms to reduce sexually transmitted infections     including HIV.   "
57219|NCT02536599|"     The aim of the study is to identify clinical and laboratory parameters, present at the time     of initial evaluation that could help predict which children with cancer, fever, and     neutropenia will be at risk for developing clinically documented infections and/ or     complications.   "
57222|NCT02536560|"     In this prospective observational cohort study the potential clinical consequences of     antibiotic use in early life and perturbations in the gastrointestinal microbiota composition     due to that antibiotic use are studied. It is hypothesized that altered microbiota may be an     important underlying mechanism for impediments in the developing immune system.      Differentiation will be made between a group of neonates who received antibiotics in the     first week of life, and control infants who were not exposed to antibiotics in the neonatal     period.   "
57223|NCT02536547|"     This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection     Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS     - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP).   "
57224|NCT02536534|"     Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity     tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with     Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension     (CTEPH) over 6 months in routine clinical practice settings.   "
57225|NCT02536521|"     This prospective observational study aimed to identify the intraoperative variables to     predict the hemodynamic change according to intra-abdominal pressure in the children     undergoing laparoscopic surgery.      The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure     variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform     amplitude (△POP),and pleth variability index (PVI).   "
57226|NCT02536508|"     Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with     Moderate to Very Severe Chronic Obstructive Pulmonary Disease   "
57227|NCT02536495|"     This phase I/II trial studies the side effects and best dose of selinexor and docetaxel and     to see how well they work when given together in treating patients with squamous cell lung     cancer that has come back or spread to other places in the body. Selinexor may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving selinexor together with docetaxel may work better in treating squamous cell     lung cancer.   "
57228|NCT02536482|"     It is a study to assess the tolerance to a new commercially available infant formula in     children affected by Cow`s Milk Allergy.   "
57229|NCT02536469|"     A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic     or unresectable, locally advanced malignant solid tumors.   "
57265|NCT02536001|"     The purpose of this study is to compare anatomical differences, quality of life and sexual     function and complications rate between apical support with one anterior vaginal mesh versus     repair with two separate meshes.   "
57271|NCT02535923|"     The goal of this project is to develop guidelines for the clinical tailoring of Cognitive     Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia,     and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving     sleep-related functional outcomes in this population.   "
57230|NCT02536456|"     China PEACE Millions Persons Project is a national screening project for cardiovascular     disease in China. This Project was approved by National Health and Family Planning Commission     (NHFPC), China and founded by Ministry of Finance, China in 2014.      The specific objectives of the project are to:        1. identify subjects at high-risk of CVD and provide counseling for medication and          lifestyle improvements        2. evaluate the feasibility of such screening methods for subjects at high risk of CVD, and          to assess the effect of health counseling on CVD incidence rates and risk factors          control        3. inform future intervention and long-term follow up efforts for primary and secondary CVD          prevention in China.   "
57231|NCT02536443|"     The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is an     observational study on an all-comer systolic heart failure population hospitalized in a     highly specialized cardiovascular center. The aim of the study is to assess the clinical     characteristics, treatment modalities and prognosis in this population.   "
57232|NCT02536430|"     The aim of this study was to determine whether combining an intraoral injection of a non     steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior     alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.     Forty adult volunteers with including criteria has been randomly divided into two groups     (n=20). All patients received standard inferior alveolar nerve block injection. After     achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the     other one received a buccal infiltration of Normal Saline as placebo. Any pain during root     canal treatment has been recorded using analog visual scale. The success was considered as     none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and     chi-squared tests.   "
57233|NCT02536417|"     The purpose of this study is to determine if melatonin administration to end-of-life patients     is effective in preventing the development of delirium compared with those who do not receive     this treatment. Delirium is a difficult to control symptom commonly seen in patients at the     end-of-life. A person who is delirious is unable to think clearly and cannot make sense of     what is going on around him/her.   "
57234|NCT02536404|"     The purpose of this study is to determine whether APD334 is a safe and effective treatment     for ulcerative colitis after 52 weeks of treatment.   "
57235|NCT02536391|"     This Phase I, open-label, randomized, 3-period crossover study was designed to determine the     relative bioavailability of ipatasertib administered as capsule and tablet formulations to     healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be     determined. Participants will be randomized to one of six treatment sequences to receive     three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in     the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the     fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations     will be performed throughout the study. Time on study is expected to be 3 weeks.   "
57236|NCT02536378|"     The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid     Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying     experience with the transcarotid technique.   "
57237|NCT02536365|"     A common feature of ASD is over or under sensitivity to the environment and difficulty     putting sensory information together in an orderly way, referred to here as sensory issues.     Building on previous work, this study will test the efficacy of Sensory Integration Therapy     (SIT), a non-invasive intervention to improve functional skills in children with ASD, in     comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms. A     total of 180 children with ASD and sensory issues in the greater New York City Metropolitan     area will complete this study.   "
57241|NCT02536313|"     This study will evaluate the efficacy, safety, and tolerability of the treatment with     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin     (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior     treatment experience with a direct acting antiviral as measured by the proportion of     participants with sustained viral response 12 weeks after cessation of treatment (SVR12).   "
57242|NCT02536300|"     This study will optimize the safety and efficacy of chronic administration of idelalisib in     participants with follicular lymphoma (FL) and evaluate the overall safety profile of     idelalisib and the overall response rate (ORR) by Week 24.   "
57243|NCT02536287|"     The purpose of this study is to compare short-term and long-term efficacy of total     parathyroidectomy with autotransplantation and total parathyroidectomy without     autotransplantation for Secondary hyperparathyroidism.   "
57244|NCT02536274|"     Aim of the study is to analyze systematically by using surface EMG the effect of the dynamic     flexion orthosis Dynaflex® and the back bandage Lumbo Sensa® on the voluntary activation of     the low back muscles and thereby on the muscles' stiffness.      Patients have to pass a course with 6 different exercises in which they have to carry out     certain activities of daily life under controlled conditions to examine, if the particular     technical aid has a positive impact on pain-related activation of the back muscles.   "
57245|NCT02536261|"     The purpose of this study is to observe whether dopamine agonists can be safely withdrawn     after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous     sinus have been effectively controlled through pharmacological treatment.   "
57266|NCT02535988|"     Patients with colorectal cancer that had metastatic lesions after been treated with     definitive surgery or chemoradiotherapy are being asked to participate in this study.        1. To observe immunity-mediated tumor response outside the radiation field (abscopal          effect) after chemoradiotherapy of a metastatic site in metastatic colorectal cancer          patients.        2. To induce the efficacy (effectiveness) of a new combination of therapy,          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic esophageal cancer          patients;        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.      This study will help find out what abscopal effects (good or bad) the combination of     radiotherapy and thymalfasin has on metastatic esophageal cancer.   "
57267|NCT02535975|"     This is a prospective, randomized, double-blind, placebo-controlled study about the effect of     metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild     ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three     times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months     after withdrawal of treatment.   "
57246|NCT02536248|"     Inflammatory processes are increasingly being recognized as a critical step in the     pathogenesis of both diabetes and heart disease and may constitute a biological link between     the two diseases. Inflammatory cytokines increase vascular permeability, change     vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus     formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing     fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important     step in the development of atherosclerosis, and adhesion molecules, such as intercellular     adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore,     identifying novel therapeutic approaches that would favorably affect inflammation,     endothelial function, and glucose is of significant interest. Investigators have recently     demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant     reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The     results also suggest that the beneficial effects of sitagliptin on both inflammation and     endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and     global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the     beneficial effects of sitagliptin on these markers remain to be fully elucidated. The     proposed study will address this key issue.   "
57247|NCT02536235|"     Paracervical blocks are routinely used in first trimester surgical abortions and are a proven     method for decreasing procedural pain. Even when paracervical anesthesia is used, an     overwhelming majority of women still report at least moderate pain during a first trimester     abortion procedure. Other than some non-pharmacologic modalities (music and visualization),     only the addition of intravenous medication has been shown to reduce procedural pain. Applied     topical heat is effective in alleviating pain in other medical subspecialties, and in     gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for     intraoperative pain control during first trimester abortion.      The investigators plan to conduct a double-blinded, randomized, controlled trial     investigating the utility of topical heat application as an adjunct to paracervical block in     first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score,     measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators     will look at the effect of heat application on pain at time of speculum placement,     paracervical block, tenaculum placement, cervical dilation and overall pain. Patient     satisfaction will also be assessed. If found to reduce pain during abortion under local     anesthesia, the use of heat could offer an inexpensive, safe and universally available     adjunct to the paracervical block during this procedure.   "
57248|NCT02536222|"     The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou     districts) and Louga (Linguère district), that were selected in 2014 on the basis of the     malaria incidence rate, the heterogeneity of transmission between villages in the health post     catchment areas, their proximity, and the availability of historical data from before 2014.     Malaria elimination strategies were already implemented in the same health posts in 2014 and     are still ongoing, thus this protocol aims to strengthen these activities. Seven health posts     with similar characteristics but with a slightly lower incidence rate were chosen as     controls. It will be implemented in all villages in the six intervention health posts and it     will consist of investigating all passively detected cases (index cases) and conducting focal     test and focal drug administration (FT/FDA) with dihydroartemisinin-piperaquine (DHAP) in all     index case and neighboring households with a positive RDT. All household members in     households with a positive RDT will be treated, regardless of their RDT results. Impact of     the enhanced Step D on malaria incidence and prevalence will be evaluated using before-after     comparison and compared to the change in the control health posts and the operational aspects     will be assessed for subsequent scale up.   "
57249|NCT02536209|"     The purpose of this study is to investigate the pharmacodynamic effect of single doses of     MT-8554 in healthy subjects.   "
57250|NCT02536196|"     The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce     the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries     during transcatheter heart valve implantation.      The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic     deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in     comparison with an active control group of patients undergoing unprotected TAVI.      Subjects with indications for TAVI and who meet study eligibility criteria will be randomized     2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard™) with     transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve     implantation.   "
63119|NCT02459470|"     The aim pf this prospective study is to investigate the ability of stroke volume variation     (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients     undergoing kidney transplantation.   "
57251|NCT02536183|"     This study is looking to determine the maximum tolerated dose (MTD) and recommended phase 2     dose (RP2D) of lyso-thermosensitive liposomal doxorubicin (LTLD) administered in combination     with MR-HIFU in children with relapsed/refractory solid tumors, which may include but are not     limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors,     osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, and germ cell tumors.   "
57252|NCT02536170|"     The aim of this study is to determine whether giving extra arginine, a simple amino acid, to     patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful     events (VOE) will decrease pain scores, decrease the need for pain medications or decrease     length of hospital stay or emergency department visit. Funding Source - FDA OOPD.   "
57268|NCT02535962|"     The purpose of study is to see if adding probiotics to corticosteroid treatment for children     with PFAPA could improve the health and daily of patients through reduction in febrile period     frequency and length, along with concomitant reduction of associated symptoms. Current     standard of care incorporates the administration of corticosteroids; however, while limiting     the symptoms associated with PFAPA, corticosteroid use has been shown to increase the     frequency at which these symptoms occur. Investigators hypothesize that administration of     probiotics along with corticosteroids will work to decrease the frequency at which the     febrile episodes occur. Additionally, probiotics may decrease the maximal fever experienced     during these episodes, amount of corticosteroid needed to control the symptoms, average     length of the episodes, and the number of patients who ultimately undergo tonsillectomy due     to unsuccessful treatment with medication.   "
57253|NCT02536157|"     Which splinting method produces the best outcomes (in range of movement, pain and function)     in the non-operative treatment of stable volar plate injuries in adults?      The volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint -     PIPJ) of the finger. It is commonly injured through hyperextension, for example a ball     hitting the fingertip. Current treatment in the Hand Therapy Unit involves splinting the     injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using     thermoplastic material. However, there is a potential risk of developing permanent stiffness     of the PIPJ into straightening, once the volar plate ligament heals. To reduce this risk, the     study aims to investigate if using a volar (on the front of the finger) gutter splint in 0⁰     flexion (straight), which still prevents hyperextension, achieves better outcomes. There is     no existing high-quality evidence comparing these two methods.      This is a randomised controlled trial. For the purposes of this study, the current treatment     of a 20° dorsal block splint will act as the control group. The intervention group will be     the volar gutter splint group. A convenience sample will be used and all patients (over 16     years old) presenting to the Mid Yorkshire Hospitals NHS Trust's Hand Therapy Unit will be     invited to participate in the study, with consideration to inclusion/exclusion criteria.     Participants will be randomised into one of two groups through the use of a random number     generator. The outcomes assessed will be range of movement, pain and function. These will be     measured at initial assessment, four and twelve weeks. These are all average normal time     intervals that patients are seen. Each splint is worn for four weeks and participants will     receive standardised advice, exercises and treatment.   "
57254|NCT02536144|"     This study is to determine the feasibility and safety of magnetic-controlled capsule     endoscopy system in examination of human colon under the real time monitoring by colonoscopy     in the clinical application.   "
57255|NCT02536131|"     Longitudinal Investigation of intestinal microbiome, fecal inflammation markers, stress and     psychological variables in patients with irritable bowel syndrome and inflammatory bowel     disease undergoing gut-directed hypnotherapy (GHT).   "
57256|NCT02536118|"     Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the     Micra Transcatheter Pacing System (Micra system) when used as intended, in real-world     clinical practice, following commercial release.      The Micra Registry is conducted within Medtronic's Product Surveillance Registry.   "
57257|NCT02536105|"     The purpose of this study is to evaluate the association between blood drug levels and the     corresponding scores of commonly used behavioral instruments based upon data collected     following administration of three different methylphenidate hydrochloride extended-release     drug products in children with ADHD.   "
57258|NCT02536092|"     To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite     and 1064nm Nd:YAG laser for hair removal.   "
57259|NCT02536079|"     The NeST registry is a pro-active industry-academic collaboration to assess the use and     safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy     data entry and retrieval of clinical information.   "
57260|NCT02536066|"     The postprandial blood glucose concentration is an important risk factor for development of     cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate     or light post-meal physical activity effectively blunts the postprandial increase in blood     glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus, the     effect of exercise on postprandial glycemia depend on the timing of exercise. Even very light     physical activity decreases postprandial glycemia when performed in the postprandial period.     The purpose of this study was to investigate whether such activity performed each day for 12     weeks would influence blood variables related to glycemic control.      METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an     intervention or a control group. They were previously diagnosed as hyperglycemic, or with     high risk of type 2 diabetes according to Ramachandran's risc score.      Control subjects were told to maintain their usual physical activity patterns during the     study period, while the intervention subjects were instructed to undertake a minimum of 30     minutes of daily post-meal physical activity in addition to their usual activity patterns.      Venous blood samples were taken before and after the 12 week intervention period. Plasma was     analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and c-peptide.     The subjects kept a physical activity diary, answered questionnaires and used accelerometers     to determine the level of physical activity.   "
57261|NCT02536053|"     This study aims to:        1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto          Extremity Salvage Score lower extremity sections and to        2. assess the functional ability and health-related quality of life (HRQoL) of lower          extremity sarcoma patients who have undergone limb salvage surgery.   "
57262|NCT02536040|"     This study is being conducted to test whether the use of diammine silver fluoride (also     called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.   "
57263|NCT02536027|"     The plasma level of neutrophil gelatinase-associated lipocalin (NGAL) in critically ill     patients with AKI is not affected by continuous venovenous hemofiltration (CVVH). However, it     remains unclear if this also applies to sepsis-induced AKI, as considerable evidence suggests     that the pathophysiology of septic AKI is different from other causes of AKI.   "
57437|NCT02533752|"     Canadian WATCHMAN Registry is a multicentre (8 Centres) Canadian prospective, non-randomized,     registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to     study the safety and effectiveness of the WATCHMAN device   "
57264|NCT02536014|"     Sympathetic activity could be increased during robot-assisted laparoscopic radical     prostatectomy, which is performed in a steep trendelenburg position under CO2     pneumoperitoneum.      Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the     susceptibility to life threatening cardiac arrhythmias.      Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties.     Perioperative administration of dexmedetomidine is a potential preventive and treatment     strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of     dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic     radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and     Tp-e/QTc ratio as well.   "
57272|NCT02535910|"     This study aims to compare the acute effect of consuming milk and butter fortified with     either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the     effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and     cognitive function will be examined.   "
57273|NCT02535897|"     The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the     absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and     carbohydrate-only controls, and to determine whether increasing plasma carnitine availability     can impact upon insulin-stimulated muscle carnitine uptake.   "
57274|NCT02535884|"     The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and     to show superiority of DBS on motor function in the stimulation group compared to     stimulation-off group   "
57275|NCT02535871|"     The primary objective of this study is to compare the efficacy, safety and tolerability of     IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.   "
57276|NCT02535858|"     Anxiety is one of the major influences on relapse and substance abuse treatment dropout.     Chemically dependent individuals need to be aware of their emotional state in situations that     jeopardise their treatment. The current therapeutic resources still subjective and with     limited treatment success. This research presents a developed virtual environment (VE)     simultaneously connected to a physiological signals device acquisition that allows, through a     biofeedback, the chemically dependents consciousness on their vulnerability front different     situations of 'risk', without a direct assessment of the therapist. Developed in 3ds Max®     software, the VE is composed of scenarios and objects that are in the habit of the chemically     dependent individual's daily life. The interaction with the environment is accomplished using     a Human-Computer Interface (HCI) that converts incoming physiological signals indicating     anxiety state into commands that change the scenes. Anxiety is characterized by the average     variability from both heart and respiratory rate of 30 volunteers undergoing stress     environment situations. To evaluate the effectiveness of the VE as a biofeedback of     chemically dependent's vulnerability front situations of risk, a total of 50 volunteers who     were drug users, monitored by 10 therapists, were enrolled. Prior VE, the results     demonstrated a poor correlation between the therapists' predictions and those of the     chemically dependent individuals. After exposure to the VE, there was a significant increase     of 73% in awareness of the risks of relapse by the chemically dependent individuals,     confirming the hypothesis that the VE coupled to the biofeedback device may assist the     therapist with treatment.   "
57438|NCT02533739|"     The purpose of these studies is to determine whether vestibular disorders could affect     visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire     and a new computerized test using a digital tablet in different studies.   "
57277|NCT02535845|"     HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true     among traditionally underserved adolescents. Few parent-targeted interventions have focused     on the parental decision-making process. Self-persuasion, generating one's own arguments for     engaging in a behavior, may be an effective means to influence parents' motivation to     vaccinate their children. In a three-phase study, investigators are using quantitative and     qualitative research methods to develop and refine a tablet-based self-persuasion     intervention for parents who are undecided about the HPV vaccine. This clinical trial     submission focuses on the third phase of the study (the second stage is also registered in     clinical trials).   "
57278|NCT02535832|"     Muscle strength helps determine a person's quality of life and functional independence.     Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic     condition called insulin resistance.      By doing this study, the investigators hope to learn why patients with rheumatoid arthritis     (RA) suffer from muscle weakness.   "
57279|NCT02535819|"     Cataract is the clouding of the lens of the eye, which initially prevents clear vision and     eventually progresses to blindness if left untreated. Cataract remains the leading cause of     blindness and an important cause of visual impairment across the globe. Cataract surgery by     ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)      Two sub-categories of phacoemulsification coexist :      Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular     techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal     endothelium plays an important role in maintaining the dehydrated state and the transparency     of the cornea. Some degree of endothelial cell loss invariably occurs in all types of     cataract surgery but the amount of endothelial cell loss may varies with the type of surgical     technique The aim of the study is to evaluate the density of the central corneal endothelial     cells before and after cataract surgery comparing two phacoemulsification techniques     (Divide-and-Conquer vs Subluxation)   "
57280|NCT02535806|"     This is a phase II study designed to investigate the combination of bortezomib with the     mitoxantrone reinduction regimen used in the ALL R3 trial. The study will enroll patients     with high risk ALL relapse including early bone marrow relapse and second or greater relapse     of any kind. Patients with relapsed LL will also be eligible. Bone marrow evaluation will be     performed after blood counts recover to assess the rate of CR (<5% bone marrow blasts) and     MRD status in children following this regimen. Further treatment with or without HSCT will be     at the discretion of the primary physician.   "
57281|NCT02535793|"     Allergy is a very common problem and can be a handicap in everyday life, specially when     symptoms occur at work place. Some persons working with drosophila developed respiratory     symptoms. Investigators tried to analyze if these manifestations could be due to a specific     allergy to drosophila.   "
57282|NCT02535780|"     The primary aim of this study is to study how Repetitive Transcranial Magnetic Stimulation     (rTMS) tailored to specific anorexia nervosa (AN) or bulimia nervosa (BN) brain activation     alterations will promote recovery and to study how inhibitory tDCS (Transcranial Direct     Current Stimulation) will reduce symptoms of body image distortion in a second sample of AN     and BN groups.   "
57283|NCT02535767|"     The purpose of this study is to determine the highest tolerable dose of primaquine within     0.75 mg/kg. A tolerable dose is defined as one in which:        -  Two or fewer participants (< 30%) experience hemolysis;        -  No participant experiences a drug-related serious adverse event; and        -  No participant requires a blood transfusion.   "
57284|NCT02535754|"     Behaviour changes such as improving nutrition, increasing physical activity, and decreasing     obesity are linked with lower mortality and morbidity and fewer cancers. Health promotion     programs in the workplace are a promising way to reach a large segment of the population.     This project evaluated the efficacy of three approaches - all of which were based on previous     research and programs with demonstrated positive benefits - on cancer-related outcomes     (healthy eating, physical activity, normal body weight) and work-related outcomes     (absenteeism, presenteeism).   "
57285|NCT02535741|"     An open label, post-market, non-randomised, historical controlled, multi-centre study of the     outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.   "
57286|NCT02535728|"     A prospective observational cohort study to assess the predictive value of preoperative     frailty on postoperative quality of life in cardiac surgery patients.   "
57287|NCT02535715|"     ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the     present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate     this novel insulin preparation as a potential therapeutic option in diabetic patients.   "
57288|NCT02535702|"     Background:      Abusing alcohol, drugs, and other substances can cause serious health problems. These     substances also can affect brain function. Researchers want to learn more about brain     function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio     waves to take pictures of the brain.      Objective:      To develop new ways to use MRI to study the brain.      Eligibility:      Healthy people 18 years of age or older.      Design:      Participants will be screened with a medical history, physical exam, and blood and urine     tests.      They will answer questions about their drug use and psychiatric history. They will be asked     about family history of alcoholism or drug abuse.      Participants will answer questions to see if they can participate in MRI.      Participants will have MRI scans. The scanner is a metal cylinder in a strong magnetic field.     Participants will lie on a table that slides in and out of the cylinder. A device called a     coil may be placed over the head.      Each sub-study will include up to 3 different MRI visits. Participants can be in multiple     sub-studies. But they can have only 1 MRI per week and 20 per year.      During MRI visits, participants may have urine collected. They may get another MRI     questionnaire.      Participants may have a clinical MRI brain scan. This may show physical problems in the     brain.      During some scans, participants may perform simple movement, memory, and thinking tasks.      Participants may be connected to a machine to monitor brain activity during the scan. Small     metal electrodes will be placed on the scalp. A gel will be placed in the space between the     electrodes and the scalp.   "
57439|NCT02533726|"     The purpose of this study is to test whether optimal patient turning, strictly every 2 hours     with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired     pressure ulcers.   "
57290|NCT02535676|"     The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct     current stimulation) for treatment of negative symptoms in patients with schizophrenia. The     proposed design is a clinical trial, randomized, double-blind, placebo-controlled study.     Participants will receive ten sessions of active or sham stimulation in five consecutive     days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be     assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the investigators     expect to see a clinical improvement of negative symptoms through scales PANSS (Positive and     Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS (Skills for     Assessment of Negative Symptoms), and expect improvement on computerized cognitive tests.     Another goal is to see improvement in biological markers related to schizophrenia, plasma and     DNA will be stored.   "
57291|NCT02535663|"     To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in     Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and     circulating cytokine levels.   "
57292|NCT02535650|"     Platinum-based chemotherapy is now regarded a standard first-line treatment for patients with     advanced urothelial carcinoma (UC). However, patients who failed to response or experienced     progression after platinum-based chemotherapy have a grim prognosis and a standard salvage     treatment is not available.      UC is known to harbor multiple mutations. In the investigators' own high-throughput molecular     profiling study, the most commonly observed mutations included TP53, FGFR3(fibroblast growth     factor receptor 3 ) and HRAS. Since RAS signaling can be attenuated using selective farnesyl     transferase (FTase) inhibitors, tipifarnib, a highly potent and selective inhibitor of FTase,     was proposed to be an effective therapeutic approach in the treatment of UC.   "
57293|NCT02535637|"     The purpose of this study is to explore the effect maternal obesity and breastfeeding play on     infant body composition. The investigators hypothesize in the first 6 months of life breast     fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and     accumulate fat at a greater rate than breast fed infants from normal weight mothers.     Furthermore, the investigators postulate that circulating maternal milk adipocytokines will     positively correlate to total fat mass at six months of age.   "
57294|NCT02535624|"     This study is designed to answer whether minimal invasive vessel clotting (angioembolization)     or open surgery (retroperitoneal packing) is more effective for pelvic fractures with massive     bleeding. Patients admitted at daytime (7am-5pm) are treated with angioembolization while     patients admitted at nighttime (5pm to 7am) are treated with open surgery.   "
57295|NCT02535611|"     The researchers aim to investigate the effect of memantine on stroke outcome in a randomized     double-blind placebo-controlled clinical trial.   "
57296|NCT02535598|"     This project aims to investigate factors that are important in affecting adherence in     internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two     intervention-specific variables, Support and Content, are important factors and that     maximizing the impact of these would result in improved adherence and potentially in the end     also better outcome for participants in internet interventions.   "
57326|NCT02535195|"     The hypothesis of this study was that ginger supplement consumption can be introduced as a     new therapeutic strategy for non-alcoholic fatty liver disease through the improved body     antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized     double-blind study was designed to evaluate this hypothesis in order to examine the     effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.   "
57297|NCT02535585|"     The shoulder is the joint that most commonly suffers dislocation, and anterior instability is     the most frequent form. Arthroscopic repair is the gold standard for the treatment of     recurrent shoulder dislocation. The most commonly used technique is the attachment of glenoid     labrum-ligament complex (GLLC) with knotted anchors. In 2001, Thal introduced the concept of     tissue fixation using knotless anchors and its applicability for GLLC lesions. Some     researchers have published studies using knotless anchors and have compared this technique to     the use of knotted anchors, demonstrating similar reconstruction of labral height and     functional outcomes, while the recurrence rate is still contradictory. To date, there are no     prospective randomized controlled clinical trial comparing these two techniques of GLLC     repairs.      The researchers aims to compare clinical outcomes and imaging evaluation of patients     undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted     anchors.   "
57316|NCT02535338|"     This phase I/II trial studies the side effects and best dose of onalespib lactate when given     together with erlotinib hydrochloride and to see how well they work in treating patients with     EGFR-mutant non-small cell lung cancer that has come back (recurrent) or has spread to other     places in the body (metastatic). Erlotinib hydrochloride and onalespib lactate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
57341|NCT02535000|"     Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation     with fentanyl demand controlled by the patient. The primary objective is to evaluate the     efficacy of duloxetine in fentanyl consumption during the postoperative period of patients     undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints     were pain scores and the presence or absence of adverse effects such as headache, nausea,     vomiting, itching, dizziness and drowsiness.   "
57298|NCT02535572|"     This open label investigation further evaluates the safety, efficacy and potential mechanisms     of action of a new form of electroconvulsive therapy (ECT). The investigators have recently     completed preliminary open-label studies with FEAST, first at Columbia University, and then     at the Medical University of South Carolina in Charleston (Nahas et al., 2013b). The     investigators have published the outcomes of the first 17 patients studied. One patient     withdrew from the study after a single titration session. After the course of FEAST (median     10 sessions), there was a 46.1 + 35.5% improvement in Hamilton Rating Scale for Depression     (HRSD24) scores compared to baseline (33.1 + 6.8, 16.8 + 10.9; P < 0.0001). Eight of 16     patients met response criteria (≥50% decrease in HRSD24) and 5/16 met remission criteria     (HRSD24≤10). Patients achieved full re-orientation (4 of 5 items correct) in 5.5 + 6.4 min     (median time = 3.6 min), timed from when their eyes first opened after treatment. The     investigators have now studied 18 more patients (see results below), and we are completing     the study in the original IDE with another two more patients still to enroll.      This work allowed us to refine the treatment. For example, the investigators selectively     modified the electrode geometry to decrease interelectrode resistance. Additionally the     investigators modified the titration schedule, now only administering a standard 800 ma     ultrabrief pulse, and thus no longer titrating in the current domain.      In this next proposed trial we will continue to gather efficacy and safety data, and compare     these to a parallel non-randomized group receiving ECT standard of care.      ECT is typically delivered in a dynamically adaptive manner, with each person having a     different number of treatments, averaging between 8-12 treatment over 4-5 weeks. We thus have     to use imprecise time points such as 'at the end of the acute treatment course' rather than     specified dates or visits.   "
57299|NCT02535559|"     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on     tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either     receive a series of two presentations or wait listed to receive them later in the school     year.   "
57300|NCT02535546|"     Patients suffering from chronic obstructive pulmonary disease (COPD) commonly get     exacerbations of their illness which have many potential triggers including infection. The     most common cause of lung infection/pneumonia is an organism named Streptococcus pneumoniae.     In Ireland a 13-valent pneumococcal conjugated vaccine (PCV-13) was recently introduced into     the childhood vaccination programme. This study aims to investigate the carriage rate of S.     pneumoniae in COPD patients over one year and to determine if isolates of S. pneumoniae found     within the COPD population would be covered by the PCV-13 vaccine.   "
57301|NCT02535533|"     This is a Phase 1 trial for safety and preliminary efficacy of the combination of axitinib     and selenomethionine (SLM) for adult patients with advanced metastatic clear cell renal cell     carcinoma (CCRCC). This will be a two part study consisting of a dose escalation and     expansion study.   "
57302|NCT02535520|"     Optovue has implemented a motion contrast imaging software in RTVue XR, a split spectrum     amplitude decorrelation algorithm (SSADA), for non-invasive imaging of ocular vasculature.     Consented subjects will undergo a series of images of the back of the eye using an Optical     Coherence Tomograpy (OCT) device, RTVue XR, in addition to the conventional images as part of     clinical routine. SSADA images will be compared with conventional methods.   "
57303|NCT02535507|"     Various driver gene mutations have been identified in lung cancer. Among them, human     epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell     lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2     receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in     patients with HER2 positive advanced Non-small cell lung cancer.   "
57304|NCT02535494|"     This investigation is one of the first large-scale, prospective attempts to obtain data on     the effectiveness of naloxone distribution among opioid-abusing populations at high risk of     unintentional opioid poisoning. Specifically, opioid abusers will be recruited from drug     detoxification sites as well as those accessing services at needle exchange programs. All     participants (N=700) will receive the standard opioid overdose education and naloxone. One     third of the participants will be randomized to receive additional in-depth psychosocial     education focusing on recognition and prevention of opioid overdose, and appropriate use of     naloxone. Another third of the participants will receive the extensive training and be     required to engage a spouse, partner, relative, or friend in this supplementary intervention.     The investigators plan to randomize individuals to each group [Treatment as Usual (TAU) vs.     Extensively Trained (ET) vs. Extensively Trained with a Significant Other (ETwSO)] and,     through continued follow up over one year, the investigators will compare self-reported     overdose reversal attempts (with and without naloxone use), naloxone-related adverse events,     and changes in patterns of heroin and other drug use.   "
57327|NCT02535182|"     This is a an ancillary study designed to explore whether an additional cell signaling pathway     (prenylation of Rap1) that was recently identified as being under beta-adrenergic control may     be affected by beta-blocker use.   "
57305|NCT02535481|"     Split thickness skin grafting is the normal standard of care for wound closure. However, this     is an invasive procedure and associated with pain also there can be additional donor site     morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical     practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that     'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This     potentially results in less pain and reduced donor site morbidity but only delivers several     cell layers to the wound so may be less effective at healing a wound. It is not known if EG     is an effective alternative to SSG.      Further the mechanism to achieve wound healing may be different. EG promotes wound healing by     expressing growth factors that accelerates wound healing and encourages keratinocyte     migration. Whereas SSG is a transplant of several skin layers that integrated to the existing     wound bed as a formal skin covering.      The investigators wish to compare these two clinical practises; epidermal grafting and split     thickness skin grafting in wound healing. Further to undertake a translational study to     investigate the mechanism by which each technique achieves wound healing.   "
57306|NCT02535468|"     The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria     Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of     the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status     of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole     blood clinical samples.   "
57317|NCT02535325|"     This phase I trial studies the side effects and best dose of methoxyamine when given together     with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage     IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as methoxyamine,     pemetrexed disodium, and cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.     Giving methoxyamine together with pemetrexed disodium, cisplatin, and radiation therapy may     kill more tumor cells.   "
57307|NCT02535455|"     Innovative approaches are needed to optimize the benefits of treatment as prevention (TasP)     among HIV+ substance users, who experience profound health disparities that amplify onward     transmission risk. This project will systematically develop, refine and conduct an open pilot     to assess the feasibility and acceptability of a two-phase emotion regulation intervention     that targets emotional barriers to HIV-related self-care among individuals who endorse active     substance use. Emotional barriers such as shame and internalized stigma have been identified     as barriers to optimal HIV care among individuals struggling with HIV and substance use. To     effectively implement TasP, strategies for addressing these barriers are needed. Utilizing     transdiagnostic approaches (e.g., positive affect-focused emotional regulation, mindfulness     and self-compassion) investigators will develop, refine and pilot a two-phase emotional     regulation intervention that requires only 5 face-to-face hours and can ultimately be     implemented by a case-management-level staff person or trained peer educator. The first phase     of the intervention will be a multicomponent in-person intervention targeting emotional,     cognitive and behavioral barriers to HIV self-care behaviors among HIV+ substance users. The     second phase of the intervention will extend the intervention benefits by sending     personalized positive self-reappraisal text messages in response to text message queries     about participants' mood. This phase will use an innovative personalized bi-directional     platform, which will leverage an existing text message delivery system. This project will be     instrumental in developing a relatively low-resource intervention strategy to address unmet     emotional barriers to optimal HIV-care among individuals who are actively using substances.     This work will provide the necessary pilot data for a subsequent grant submission to assess     the preliminary efficacy of the intervention. The resulting intervention has the potential to     address emotional barriers to self-care along the HIV care cascade: including retention in     care, antiretroviral treatment adherence and persistence, and ultimately viral suppression.   "
57308|NCT02535442|"     The objective of this study is to evaluate the microbial consortia and the host inflammatory     factors present in the nasal passages of patients during upper respiratory symptomology and     when healthy using culture and molecular analysis techniques.   "
57309|NCT02535429|"     Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and     quality of life   "
57310|NCT02535416|"     Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.   "
57311|NCT02535403|"     Cognitive behavioral therapy (CBT) is a well-documented and effective method for the     treatment of children and adolescents with anxiety disorders. Lately there has been an     increase in the development and use of internet-based CBT programs (ICBT), as a means to     reduce costs and enhance accessibility of psychological interventions. ICBT has proven     efficacious towards adults with anxiety disorders. Research in the field of ICBT with     children and adolescents is still in its infancy though and to date, no program targeting     anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this     study is to investigate the efficacy of a newly developed internet-based treatment program     for adolescents with anxiety disorders. The effect will be examined in a randomized     controlled trial comparing ICBT to a wait-list control condition.   "
57312|NCT02535390|"     Major depressive disorder places a tremendous burden on workplace disability each year. Its     diagnosis is based on the presence of characteristic symptoms that include disturbances in     mood regulation, maladaptive beliefs, and behaviour. Impairment in neurocognitive functions     (e.g., information processing speed, attention, memory, problem solving skills) is absent     from current diagnostic criteria and off the radar in most clinical treatment settings, yet     increasingly recognized as a primary cause of poor work functioning and outcomes. This     disconnect between the root causes of poor vocational outcomes and targets of treatment has     resulted in a failure to return to work following illness, job underproductivity, and     work-related stress, which contribute to indirect costs to society each year. The     investigators seek to expand scientific support for treating neurocognitive impairments in     order to increase occupational productivity and reduce job-related stress associated with     depression. The investigators developed a novel group cognitive remediation (CR) treatment,     Action-Based Cognitive Remediation (ABCR). It builds on procedural learning skills with     explicit work-related role-plays to facilitate immediate and salient abstraction of drill and     practice remediation techniques. The activities were developed in collaboration with a     community rehabilitation partner in this study through systematic interviews with job     placement specialists and supervisors from employment sites used by the agency. The props     match those used in work settings and include miniature versions of a cash register, filing     system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The     activities capitalize on procedural learning skills through roleplays and props that simulate     a work environment. ABCR maintains important aspects of drill and practice, strategic     monitoring to enhance flexible problem solving approaches, and bridging. The role-plays     follow computerized drill and practice exercise and therapists facilitate group discussions     of how cognitive skills and flexibility in thinking from drill and practice can be effective     while directly engaged in an everyday work environment. Thus, bridging used in ABCR is a     tangible, procedural, and realistic. This approach to bridging differentiates the treatment     from standard CR, where the discussion-based approach is limited by the auditory learning,     memory, and abstraction deficits observed in depression.   "
57328|NCT02535169|"     This study looks as how a health education intervention strategy effects health outcomes in     overweight and obese adolescents.   "
57329|NCT02535156|"     Neurophysiological indices of self-monitoring were assessed in a group of patients with     Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after     the administration of risperidone and placebo.   "
57313|NCT02535377|"     Sperm freezing has been employed for decades for male fertility preservation in cases of     foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a     complement of assisted reproduction techniques.      Sperm quality after thawing is highly variable, even among consecutive samples from the same     individual, with mean survival rates around 40%. To date, the molecular basis of the adequate     resistance or intolerance to freezing/thawing protocols is unknown, and its knowledge can     lead to improvement in the selection of the samples to be frozen and also in the adequate     supplement of cryopreservation media. Microarray analysis provides a powerful tool to address     the molecular explanation beyond this behaviour, yielding results about comparative messenger     ribonucleic acid (mRNA)expression under the two different biological conditions: optimal and     suboptimal survival.      Then, the aim of the investigators' study is to determine the genomic profile of sperm     samples depending on their survival resistance to cryopreservation, to determine genes     involved in cryodamage sensitivity.   "
57314|NCT02535364|"     This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or     refractory B-ALL with an infusion of the patient's own T cells that have been genetically     modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that     express the CD19 protein on the cell surface. The study will determine if these modified T     cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will     also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's     body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this     treatment on survival.   "
57315|NCT02535351|"     Two randomized trials in the cytokine era clearly showed that cytoreductive nephrectomy (CN)     had a role in metastatic renal cell carcinoma (mRCC) increasing life expectancy. The survival     benefit of tyrosine kinase inhibitors (TKIs) including first-line sunitinib and pazopanib in     mRCC has been demonstrated, but the majority of patients enrolled in the pivotal phase III     studies had undergone nephrectomy.      Therefore it is unknown if similar survival benefit could be achieved without CN with these     new targeted agents.      At the same time there is a need to better understand mechanisms of primary and secondary     resistance to TKIs in mRCC patients and to identify eighter prognostic and predictive     biomarkers to better define risk factors and potentially druggable targets.   "
57440|NCT02533713|"     This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on     the musculoskeletal system and health-related quality of life.   "
57318|NCT02535312|"     This phase I/II trial studies the side effects and the best dose of methoxyamine when given     together with cisplatin and pemetrexed disodium and to see how well it works in treating     patients with solid tumors or mesothelioma that have spread to other places in the body and     usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma     that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory).     Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work     better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as     cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a     better treatment for solid tumors or mesothelioma.   "
57319|NCT02535299|"     Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in     Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about     telomere-telomerase system and Par-4.   "
57320|NCT02535286|"     The purpose of this study is to evaluate the safety and effectiveness of pembrolizumab in     combination with ublituximab and TGR-1202, in patients with advanced CLL or Richter's     Transformation.   "
57321|NCT02535273|"     Evaluate safety and efficacy of dexmedetomidine in minimally invasive spine surgery under     local anesthesia sedation.Explore the appropriate concentration of dexmedetomidine, whether     or not can reduce the amount of local anesthetics.   "
57322|NCT02535260|"     This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home     setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) by     female volunteers seeking to get pregnant.   "
57323|NCT02535247|"     This is a multicenter, single-arm, open label 2-stage phase 2 study exploring monotherapy     with the PD-1 antibody pembrolizumab (or MK-3475) given intravenously at a fixed dose of     200mg every 3 weeks for up to 36 cycles for patients with relapsed or refractory Peripheral     T-cell Lymphoma (PTCL), who have received at least 1 prior systemic therapy. The primary     endpoint of the study is progression-free survival. Secondary outcomes are overall survival     and response rate. Patients will be assessed for response with PET CT or CT every 12 weeks     using the revised Cheson criteria. Correlative endpoints will be exploratory and assess PD-1     expression on peripheral blood lymphocytes; peripheral blood T-cell and NK-cell functional     assays; PD-1 and PD-L1 expression on tumor tissue; and tumor infiltrating lymphocytes as     prognostic and predictive biomarkers.   "
57324|NCT02535221|"     This study proposes to prove that the efficacy of adjuvant endocrine therapy for the     premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy     assessed by ultrasound response rate.   "
57325|NCT02535208|"     The primary aim of this study is to determine the mean number of red blood cell (RBC)     transfusions received by preterm infants cared for using restrictive Hgb guidelines in     combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the     mean number of transfusions received by preterm infants cared for using liberal guidelines     alone.      This study is designed as a prospective randomized controlled trial. Preterm infants less     than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled     into the study during day of life 0 to 3. Study participants will be randomly assigned into     two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal     group, RBC transfusions will be given to subjects when their Hgb level falls below defined     values that are based on respiratory support status. In the restrictive group, RBC     transfusions will be given to subjects either when their Hgb level falls below defined values     based on respiratory status or, despite not having reached their Hgb trigger threshold, if     they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e.     apnea, bradycardia, or desaturation episodes) and subsequently have a near-infrared     spectroscopy (NIRS) evaluation that demonstrates an SCOR < 0.73.   "
57338|NCT02535039|"     Postoperative cognitive dysfunction (POCD) refers to the patients in the central nervous     system complications after general anesthesia and clinical manifestations of mental disorder,     anxiety, personality changes, impaired memory, personality, social skills and cognitive     function after surgery for this decline is called postoperative cognitive dysfunction.Due to     the lack of effective clinical treatments, how to prevent and solve the postoperative     cognitive dysfunction has become a difficulty and a focus of research in the field of     anesthesia.Methylprednisolone is a new type of cortical hormone, because of its strong     anti-inflammatory effect, less adverse reactions, is widely used in clinical     anesthesia.Electric acupuncture as a kind of traditional treatments, after years of clinical     application and achieved good curative effect in practice.In this paper by comparing brain     oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on     cognitive function in patients with grade indexes, such as observation of methylprednisolone     combined electric acupuncture treatment of elderly patients with general anesthesia early     after the operation, the influence of cognitive function.      Through comparing the operation of cerebral oxygen saturation, blood biochemical indexes,     Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade     indexes, such as observation of methylprednisolone combined electric acupuncture treatment of     elderly patients with general anesthesia early after the operation, the influence of     cognitive function.   "
57330|NCT02535143|"     This study aims to test the hypothesis that there was a relationship between the consumption     of energy drinks and the manual dexterity skills of final year dental students.      Identification of baseline caffeine consumption and selection of sample Baseline caffeine     consumption will be identified by distributing the caffeine consumption questionnaire to all     the final year students of the Riyadh Colleges of Dentistry and Pharmacy. The study will     recruit 60 students who are moderate caffeine consumers. To avoid the confounding effect of     nicotine consumption, the study will only recruit non-smokers .female candidates taken oral     contraceptives and Subjects with any history of renal disease will be excluded.      All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK,     Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the     cavity in each test both cavities will be selected for assessment. The ability of the     participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the     task will be used as criteria to evaluate dexterity. The participants will be required to     perform the test before and 30 minutes after energy drink exposure.      Energy Drink Exposure Subjects will be given 330ml of an energy three hours after the last     meal in the other hand the control group will be receiving a placebo drink .      Dexterity outcomes will be compared before and after exposure to the energy drink using the     paired t test. Outcomes will be compared between different groups and different time     intervals using the two way, multiple measures ANOVA. All data will be analyzed using the     SPSS ver.21 data processing software.   "
57331|NCT02535130|"     The purpose of this study is to compare the efficiency of nebulization and positive     expiratory pressure combination   "
57332|NCT02535117|"     Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death     from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC     accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to     the lack of donors Recurrence of tumor within the liver remnant is also common, with a     reported 5-year recurrence rate of 50-70%, in patients who have undergone curative     hepatectomy. Management of recurrent HCC is still urgent and several treatments have been     developed. Repeat hepatectomy is considered to be the first choice for recurrent HCC with a     5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only     in a small proportion of patients with HCC recurrence due to the poor functional liver     reserve or because of widespread recurrence. With a 3-year survival rate of 62% to 68% after     treatment, radiofreqency ablation (RFA) has been used as an effective treatment for recurrent     HCC. The efficacy of RFA for recurrent HCC has been reported to be comparable to those     achieved by surgery. Laparoscopic surgery was considered not to be a suitable treatment for     recurrent HCC due to postoperative adhesions that can make laparoscopic surgical procedure     more difficult and less safe. Recently, several studies reported that laparoscopic surgery     for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term     outcomes. By far, no study has been performed to compare the efficacy and safety of     laparoscopic surgery with RFA for treatment of recurrent HCC.   "
57333|NCT02535104|"     Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical     treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety     of a topical formulation of ranpirnase in subjects with genital warts.   "
57334|NCT02535091|"     This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089     as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking     phenytoin or phenobarbital will be enrolled followed by additional subjects taking     anti-epileptic drugs other than phenytoin and phenobarbital to further investigate long-term     safety.   "
57335|NCT02535078|"     This study is a Phase Ib/II, multi-center, open-label study of IMCgp100 as a single agent and     in combination with durvalumab (MEDI4736) and/or tremelimumab in metastatic cutaneous     melanoma. The purpose of this study is to characterize the safety, tolerability,     pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of IMCgp100 in combination     with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab (CLTA-4     inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent     IMCgp100 alone. The study will enroll patients who have metastatic melanoma that is     refractory to treatment with an anti-PD-1 inhibitor as well as patients naive to therapy in     the metastatic setting.      Recent biologic evidence indicates that optimal responses to programmed cell death-1 (PD-1)     directed therapy require the presence of CD8+ T cells in the tumor microenvironment and thus     therapies such as IMCgp100 that recruit these effector cells to the tumor may overcome     pre-existing resistance to checkpoint blockade. This emerging biology of checkpoint inhibitor     resistance suggests the combination of IMCgp100 with checkpoint inhibition may have enhanced     activity in patients with pre-existing resistance.   "
57336|NCT02535065|"     The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study     the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in     conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic,     aortoiliac, and iliac aneurysms.   "
57337|NCT02535052|"     This study will investigate the function of the immune system in people with chronic kidney     disease (CKD) compared to people with normal kidneys. The investigators will use standard     vaccines - the seasonal flu vaccine and pneumococcal polysaccharide (Pneumovax) vaccine - to     examine how the immune system responds to challenge. All subjects will receive these     recommended vaccines as part of routine care. Blood and urine samples will be collected and     tested at different time points to look at how the immune response develops to these vaccines     and if there are any differences between people with CKD and those without. This will help us     understand how CKD affects the function of the immune system.   "
57339|NCT02535026|"     This is a descriptive, prospective, observational and epidemiological study on participants     recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.   "
57340|NCT02535013|"     Investigators hypothesized that perioperative lung ultrasound would be beneficial in     pediatric patients undergoing cardiac surgery compared to those who did not receive lung     ultrasound.   "
57474|NCT02533271|"     The purpose of this study is to compare effectiveness of short-term radiotherapy with     neoadjuvant chemotherapy(Experimental group) with preoperative long-term     chemoradiotherapy(Control group) in locally advanced rectal cancer. The hypothesis is 3-year     disease-free survival in Experimental group was non-inferior to that in Control group.   "
57342|NCT02534987|"     The study is a randomized controlled trial, with an Intervention Group and a Control Group at     the University of Utah (U of U) and University of Wisconsin (UW). BU serves as the primary     award and coordinating institution. The unit of randomization will be at the clinic level at     each institution. UW will recruit all General Internal Medicine (GIM) Clinics and Department     of Family Medicine (DFM) Clinics in Dane County as well as their East and West Urgent Care     Clinics. U of U will recruit all affiliated primary care practices. The unit of randomization     will be the clinic.      The study biostatistician will receive a list of clinic sites that have agreed to participate     in the study from the site PIs. Clinics will be randomized to either Intervention group or to     a Control group stratified by clinic size. Both groups will receive a single 45 minute     academic detailing session describing evidenced-based diagnosis and treatment for strep     throat and pneumonia. The Intervention Group will also receive a demonstration of the iCPR     tool during their academic detailing session. Providers and clinic staff will be invited to     the academic detailing session. Any provider or staff that is unable to attend the session     will receive written and electronic copies of the material. Individual providers will not be     specifically recruited for participation and they will participate or not based on personal     preferences as they would for any clinic quality improvement project. The iCPR tool will be     turned on for providers in the Intervention group. This means that the best practice alerts     will trigger for appropriate patients with suspected strep throat or pneumonia.      We will collect and analyze data about the use of each element of the iCPR tool during     patient visits, including which elements of the tool were used and how often. We will also     collect data from the site EHRs about antibiotic and diagnostic test orders for strep throat     and pneumonia from all clinics participating in the trial, both Intervention and Control     groups.      After one year of study implementation, we will run an Interim Primary Outcome Report     comparing the antibiotic and diagnostic test orders between the Intervention and Control     group clinics. This report will be in the aggregate and will not contain any     personally-identifiable information. If there is a significant difference between the groups     that meets our predetermined stopping end points, we will stop the randomized controlled     trial.   "
57343|NCT02534974|"     Ventilation-associated pneumonia is the main site of healthcare-associated infections in the     severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia     increases morbi-mortality, length of stay in intensive care and overall management costs. As     was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of     nosocomial infections contracted in intensive care, success in this preventive endeavour     depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure     between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal     care at regular intervals, striving to avoid unscheduled extubation, and use of a written     sedation-analgesia algorithm allowing for early weaning from ventilation.      Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in     maintaining tracheal balloon pressure than intermittent adjustments using a hand-held     manometer. In one study, these devices clearly facilitated diminution of microaspiration of     gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22     VAP/1000 days of mechanical ventilation; p = 0.005).      The investigators are putting forward the hypothesis that by adjoining a device providing     continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at     ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°,     oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP     incidence by 50% in severely traumatised patients whose condition necessitates mechanical     ventilation of an expected duration exceeding 48h.      Ours is the first large-scale study to evaluate the interest of an innovative technology     bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care     populations the most at risk, namely severe trauma patients, a population presently     benefiting from the other recommended preventive measures.   "
57344|NCT02534961|"     This randomized prospective study aims to investigate whether prophylactic administration of     antibiotics has an influence on inflammatory markers, liver function test results, or the     incidence of post-procedural infection in patients with hepatocellular carcinoma (HCC)     undergoing radiofrequency ablation (RFA).   "
57345|NCT02534948|"     Anxiety and depressive disorders are common in all regions of the world. Anxiety disorders     are considered as third major psychological issue in Pakistan (Panhwer, 2014). Objective of     the present study is to see the feasibility and effectiveness of social anxiety in females     with the help of mindfulness and acceptance based therapy. It is hypothesized that women in     the intervention group will have significantly reduced anxiety as compared to the women in     the control group. A total of 60 females in the age range of 18 to 28 ages will be selected     from Institute of professional psychology and private clinics from Karachi city. The     participants will be recruited through the administration of Mini-Social Phobia Inventory     (SPIN-mini). The participants will be randomly divided in interventions and control group and     will receive the intervention of ten sessions of group therapy of MABT plan. Assessment will     be conducted at the baseline and at the end of the intervention.   "
57346|NCT02534935|"     The purpose of this study is to investigate the immunogenicity, safety and tolerability of a     new vaccine that might prevent meningococcal B disease. The study will be conducted in     healthy toddlers aged between 12 and 24 months.   "
57347|NCT02534922|"     This trial is a Phase I open-label safety study of Prolanta™, a recombinant analog of the     human prolactin protein with a single amino acid substitution to create an antagonist of the     prolactin receptor. The Sponsor believes that blocking the prolactin receptor in patients     with ovarian and other cancers will be effective as a monotherapy or in combination with     other chemotherapies. This Phase I study will be conducted in Subjects with recurrent or     persistent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.   "
57348|NCT02534909|"     To determine whether LFG316 can induce a hematological response, as measured by reduction in     hemolytic activity, in patients with PNH.   "
57349|NCT02534896|"     This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects     with active rheumatoid arthritis who are experiencing a flare/exacerbation.   "
57695|NCT02530359|"     Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF     600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and placebo     equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days, all     receive conventional treatment KDIGO guides. We analyze the recovery of renal function as a     primary objective.   "
57350|NCT02534883|"     Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours     pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix     for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical     instrument) into the uterus for all operative hysteroscopic procedures requiring dilation     above 5 mm.      Time required for cervical dilatation will be recorded. Start time will be when the smallest     dilator is placed into the endocervical canal, and stop time recorded when the desired     cervical dilation is achieved with the largest dilator. Depending on the procedure, desired     dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of     dilatation.      The investigators will compare the two groups in terms of medication, resistance, dilation     time and size, side effects and surgical complications.   "
57351|NCT02534870|"     The purpose of this study is to assess the pharmacokinetics and safety of multiple oral doses     of ABT-450/ritonavir/ABT-267 and ABT-333 when co-administered under non-fasting conditions in     healthy Chinese adult participants.   "
57372|NCT02534597|"     This evaluation seeks to assess the impact of a training program on childcare center     environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized     control trial, over 200 childcare centers participating in the program will be assigned to     various treatment arms receiving different components of the program. A community comparison     cohort will also be enrolled.   "
57638|NCT02531100|"     This study is designed to assess the safety and effectiveness of BonyPid-500TM implantation     for intrabony peri-implantitis defects.      BonyPid-500™ is a bone graft substitute, which contains an antibiotic drug - doxycycline, and     is intended for filling and reconstruction of bone defects caused by peri-implantitis.   "
57352|NCT02534857|"     In vitro fertilization (IVF) treatment is now commonly used to treat infertile couples.     During IVF treatment, oocytes and sperm are routinely incubated overnight and this may lead     to suboptimal culture conditions because of increased reactive oxygen species (ROS) produced     by sperm in the standard incubation. High levels of ROS can adversely affect the quality of     the embryos, result in hardening of the zona pellucida and impair the implantation capacity     of embryos. Studies shows successful fertilization of an oocyte occurs 20mins after the     gametes are put together. Sperm can penetrate through the cumulus cells within 15min, and 80%     of oocytes can be fertilized when they are exposed to a large number of spermatozoa within     1hr. As an attempt to avoid possible detrimental effects on the oocytes from long exposure to     sperm, the brief incubation insemination protocol was developed. It implies that prolonged     incubation of oocytes and sperm may not be necessary and may even be harmful. Some reports     suggest that a sperm-oocyte exposure time of 1-6 h improves IVF outcomes. However, other     studies report no such advantage with a short insemination time .      A recent meta-analysis shows brief incubation of gametes was associated with significantly     higher rates of clinical pregnancy , ongoing pregnancy and higher rate of implantation than     standard incubation. But the rates of normal fertilization, good quality embryos and     polyspermy were not significantly different compared with standard incubation. In a Cochrane     meta-analysis, eight RCTs with 733 women were included, and showed similar results. But it     only reported clinical pregnancy rate and ongoing pregnancy rate which were significantly     higher in brief incubation group than standard incubation. However, the live birth rate,     which is the important outcome parameter, was not reported in all these studies. It is     uncertain whether brief incubation improves the life birth rate compared with standard     incubation.      The aim of this randomized double blinded study is to compare the live birth rate of IVF     treatment following brief incubation of oocytes and sperm versus standard incubation. The     hypothesis is that a brief incubation improves the live birth rate of IVF treatment.   "
57353|NCT02534844|"     This study evaluates the efficacy and safety of 2-hydroxypropyl-β-cyclodextrin (VTS-270) in     patients with neurologic manifestations of Niemann-Pick Type C1 (NPC1) Disease. Approximately     two-thirds of patients will receive the study drug, 2-hydroxypropyl-β-cyclodextrin (HP-β-CD),     while the remaining study participants will receive sham control.   "
57354|NCT02534831|"     Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease     characterized by progressive airflow limitation that is associated with an inflammatory     response to noxious particles or gases.      Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to     provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such     as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization     and joint manipulation. The suggestion that MT could deliver long-term benefits to people     with COPD was first put forward in 2009. Since then a number of small studies have reported     medium term improvements in lung function and exercise capacity following repeated     applications of MT intervention.      Our aim is to measure the immediate effect on lung function of a single application of soft     tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary     disease.   "
57355|NCT02534818|"     The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive     the same detection rate per patient and per lesion for the detection of gastric intestinal     metaplasia.   "
57356|NCT02534805|"     To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients     using a patient and caregiver perspective.   "
57357|NCT02534792|"     Aim With this retrospective study, the investigators would like to evaluate and, if possible     confirm, whether earlier revalvulation of the right ventricular outflow tract is better than     late revalvulation. Up to now, no analysis is done to validate this policy change.      Patient selection All patients registered in the database of paediatric and congenital     cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who     underwent transannular patching at repair will be included in the study.      Methodology and statistical analysis All files will be reviewed for demographic,     electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics,     Cox regression will be performed to detect whether the time period between repair and     revalvulation influences clinical outcome (defined as death, heart failure hospitalization,     redo-revalvulation, implantation of automatic defibrillator, endocarditis).   "
57358|NCT02534779|"     This open-label study will examine the disintegration/disappearance time, safety, and     acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert     twice: first for an in-clinic disintegration/safety assessment, and a second time for an     at-home acceptability assessment, with safety assessed at the following clinic visit.   "
57377|NCT02534532|"     Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a     primary healthcare environment using a smartphone device and iECG application as an     opportunistic screening tool?      Objectives:      Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an     opportunistic screening program using a smartphone device/application        1. Define the predictable value of the smartphone device with electrocardiogram (ECG)          confirmation to detect AF in patients 65 years and older        2. Correlate screened patients cardiovascular risk profile and those that register cardiac          rhythm irregularities for a better description of the general characteristics of          Colombian population   "
57359|NCT02534766|"     MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary     Disease (COPD) care and has the potential to change the way COPD care across the UK is     delivered as well as services for other long term health conditions. The MISSION model has     been piloted in asthma which is the subject of an ongoing research study. This is the first     model of this type in COPD and the current research study aims to evaluate the outcomes of     the project. This will be done in several different ways. The study is a mixed methods     evaluation of the new service comparing outcomes before and after the clinic using     retrospective data analysis and prospective qualitative interview. The study will be     conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD     clinics as well as staff who attended MISSION clinics in a professional capacity.   "
57360|NCT02534753|"     This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic     Acid.   "
57361|NCT02534740|"     This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of     tafamidis will be compared. Subjects will be fasted for each test and every subject will test     all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will     be measured periodically for 6 days. After 14 days, subjects will take a different     formulation of tafamidis and tafamidis blood concentrations will be measured periodically for     6 days. After another 14 days, the last formulation will be tested in the same way. In part 2     of the study, depending on the results of part 1, either none, one or 2 of the formulations     tested in part 1 will be tested comparing the same formulation when given either with or     without food. Additionally, depending on the results of part 1 of the study, different doses     of the formulations may be compared.   "
57384|NCT02534441|"     The primary objectives of this study are to identify positivity rates to three novel     surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower     the surface tension of the skin and remove debris) and co-reactivity with other surfactants     in patients with known surfactant sensitivity on skin patch testing. The investigators     hypothesize that subjects who previously tested positive to known allergenic surfactants     (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut     diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate     co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate,     isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch     testing.   "
57362|NCT02534727|"     Background:      Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM)     infections. Sometimes medicine that treats these infections does not get to where the     bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is     getting to where it is needed in the lungs. They will look at how much medicine is in your     sputum (what you cough up) compared to how much is in your blood. They will also investigate     a new test to quickly figure out what medicines are likely to treat TB effectively.      Objective:      To determine the relationship between the concentration of TB drugs in plasma and sputum over     time.      Eligibility:      People ages 18 and older who have TB or NTM infection that is suspected to be drug resistant.     They must be taking TB or NTM medicines.      Design:      Participants will be screened with medical history.      Participants will be in the study for 2 8 days.      Participants will give 3 or more sputum samples over at least 2 different days. They will     cough sputum into a cup.      Participants will have blood drawn 4 times a day on 2 different days.   "
57363|NCT02534714|"     The purpose of this study is to determine if there is correlation between Vitamin D     deficiency and spinal disease/spinal fusion surgery.   "
57364|NCT02534701|"     To monitor the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter     on artery recanalization and on clinical outcomes in stroke patients using data from clinical     routine application (ERASER).      To additionally evaluate the effect of the ERIC® device in combination with SOFIA™ Distal     Access Catheter on the final infarct volume as determined by advanced image postprocessing     methods in the subgroup of patients with acute middle cerebral artery stroke (ERASER+).   "
57365|NCT02534688|"     randomized controlled trial      Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea     Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule     Cul-de-sac nodularity Endometrioma detected by ultrasonography size < 4 cm      Inclusion criteria Female age 18-45 yr Moderate to severe pelvic pain categorized by VAS >50     Previous sexual intercourse      Exclusion criteria Co-existing other genital tract disease associated pain Previous hormonal     use within 3 months History of DMPA treatment failure WHO eligibility criteria 2009 for DMPA     and LNG-IUS Category 3,4 Fertility desire in upcoming 1 year      Primary objective To compare efficacy of pain control in endometriosis associated pelvic pain     between LNG-IUS and DMPA      Secondary objective To compare side effect, continuation rate, satisfaction and quality of     life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain      Primary outcome Severity of pelvic pain Measured by VAS score 0 mean no pain 100 mean most     pain      Secondary outcomes Vaginal bleeding pattern Side effects of systemic progestogen Lipid     profiles Weight gain Quality of life Measured by quesionaire SF36 Satisfaction Measrured by     linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3     satisfied 4 very satisfied Continuation rate Endometrioma size reduction   "
57366|NCT02534675|"     The purpose of this study is to learn more about personalized cancer therapy including     response to treatment and side effects. Information from the patient's medical record     regarding the tests and treatments they have received, or will receive, for their cancer will     be collected. Genomic testing on tissue from the primary tumor or metastases will be used to     match therapy recommendations. Patients in which there is no appropriate matched therapy will     receive systemic chemotherapy according to their treating physician's discretion. This     information will be used to describe whether or not patients respond better when their     physicians choose to treat them according to the genetic makeup of their tumor.   "
57392|NCT02534337|"     The purpose of this study is to determine that Gemcitabine(GEM) plus oxaliplatin(OXA) (GEMOX)     is superior to Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging     progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.   "
60187|NCT02497781|"     This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam     (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with     complicated urinary tract infections.   "
57367|NCT02534662|"     Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty     (EVG) using an endoluminal-suturing device.      Briefly, Vertical gastric plication is a novel surgical approach for reducing the stomach     capacity. Anterior surface plication and greater curvature plication are variations of     vertical gastric plication that reduce the gastric capacity through infolding of the anterior     surface or greater curvature of the stomach, respectively. These approaches have been tested,     with positive results.      A transoral or endoluminal approach (ie, a procedure that requires no incision, because     access is granted through the mouth) offers the potential for additional benefit to the     patient, because the procedures continue to become more and more minimally invasive.      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring     bariatric procedures performed via flexible endoscopy. Although these procedures may not be     as effective as their surgical counterparts, these less-invasive options may relieve patients     of the significant risks associated with surgery.      Study duration and number of subjects A period of approximately 6 months is anticipated form     the time the time the first patient is enrolled to the completion of the last patient.      The participants will be followed as follow:      Day (0): Procedure Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects     observed)      1 month: Follow up endoscopy, Clinical assessment 3 month: Follow up endoscopy, Clinical     assessment 6 month: Final assessment (Endoscopically and Clinical) On Parallel a nutritional     specialist will monitor the patient on quarterly basis (1,3,6,12).      Study procedures The intervention will be performed under general anesthesia with tracheal     intubation. Endomina will be introduced into the stomach over guide wires and then fixed to     the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior     sutures after argon plasma coagulation of the tissue opposition areas in order to ensure     persistence of the pouch reduction. Patient will be kept overnight after the procedure.   "
57368|NCT02534649|"     This is a biology driven, monocentric study designed to identify actionable molecular     alterations in cancer patients with advanced disease.      In this trial, high throughput analysis will be carried out using next generation sequencing,     and immunological profiling.      Patients included in the BIP study and for whom a targetable genomic alteration had been     identified might be subsequently included in an early phase trials running at Institut     Bergonie or another French hospital.   "
57369|NCT02534636|"     The purpose of this study is to establish if BMS-986165 is safe and effective at treating     autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for     inhibiting autoimmune conditions. This study will be the first time this drug is given to     humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A     will investigate single oral doses of drug. Part B will investigate giving the drug daily for     14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese     decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule     makes a difference to the safety and potential use of this drug.   "
57370|NCT02534623|"     Transurethral resection of the bladder (TURB) is often performed as an outpatient procedure     so high-quality postoperative recovery is particularly important. The aim of this study is to     compare postoperative quality of recovery after spinal anesthesia (SA) and general anesthesia     (GA) for transurethral resection of the bladder.   "
57371|NCT02534610|"     Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in     total knee arthroplasty (TKA).   "
57373|NCT02534584|"     This study is a service evaluation to assess the impact of compliance of Acute Kidney Injury     care bundle (AKI-CB) on clinical and renal outcomes. The AKI care bundle is coupled with an     interruptive electronic alert, which is triggered by the first attempt to order blood tests     or medications on patients who have been identified as having AKI by the electronic     recognition from serum creatinine results. The interruptive alert will warn the clinician     about AKI and request them to complete the AKI care bundle. Once the AKI care bundle is     completed, the clinician is able to request blood tests or medication. The clinician will be     able to override the alert only after stating the reason. Education with respect to     importance of AKI and the AKI-CB is provided every four months when junior doctors rotated     through different specialities and also at clinical governance days. The investigators will     compare AKI episodes, which have the AKI-CB completed early (defined as within 24 hours of     availability of the blood results) with those who either had the AKI-CB completed late     (defined as after 24 hours of availability of the blood results) or not completed at all. The     AKI patients who either had the AKI-CB completed late or not completed will be considered as     not having the AKI-CB completed for this analysis.   "
57374|NCT02534571|"     Acute upper gastrointestinal bleeding is a common medical emergency. Bleeding peptic ulcers     and other non-variceal causes constitute to about 95% of all cases of bleeding. Endoscopic     treatment stops active bleeding, reduces rate of further bleeding and leads to improved     patients outcomes. Endoscopic treatment can be technically demanding especially with lesions     in difficult anatomic positions and to endoscopists with less experience. TC-325 is a     propriety mineral blend hemostatic powder used to compress external civilian and military     traumatic injuries. Investigators reported the first endoscopic application of TC-325 in 20     patients with actively bleeding gastro-duodenal ulcers. Investigators were able to stop     bleeding in 19 of them. Subsequent case series from others reported a similar rate in the     acute control of bleeding. To further define the role of TC-325 as a mono-therapy, a     comparison to the current standard in endoscopic treatment is required. A non-inferiority     randomized trial is being proposed to compare endoscopic use of TC-325 as a mono-therapy to     current standards (i.e. hemoclips or thermo-coagulation with or without pre-injection with     diluted epinephrine) in hemostatic treatment in patients with acute upper gastrointestinal     bleeding from non-variceal causes. The non-inferiority primary endpoint is control of     bleeding over 30 days from randomization. Other outcome endpoints include further endoscopic,     angiographic or surgical treatments, hospitalization, blood transfusion and mortality.     Investigators also compare ease of therapy measured by procedure time and a 10 cm visual     analogue scale rated by endoscopists. Endoscopic application of TC-325 is a simple and less     skill dependent technique. It may prove useful in bleeding from anatomically challenging     sites of the gastro-duodenal tract.   "
57375|NCT02534558|"     The team integrates experimental analyses of clinical and basic medicine and transgenic mice     models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts     of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue     homeostasis that alleviates tissue stiffness and maintains function.   "
57376|NCT02534545|"     The primary objective of the study will be to determine whether remote limb ischemic     conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of     recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial     artery.      After screening period, eligible patients will be randomly allocated into 2 groups. In     addition, all participants receive an usual clinical therapy.   "
57378|NCT02534519|"     No health condition(s) are studied. Genetic background of blood groups is studied. U- and     Stones(a)+ (Caucasian type) are used as proof-of-principle samples. Disease associations of     all blood group genes investigated are very rare, e.g. < 1 among 1'000 Swiss individuals (see     table 1), and are not to be expected in the course of this study.      Genomic DNA of 2 U- samples were both provided as blinded reference material from New York     and Vienna blood centres, respectively. Both donors are lost for follow up, and although     there is no documented evidence for refusal of the respective donors to use their material in     research projects, samples still lack informed consent.   "
57379|NCT02534506|"     The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects     with advanced and/or metastatic malignant tumors.   "
57380|NCT02534493|"     A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a     novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical     function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).   "
57381|NCT02534480|"     NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease     amyloid buildup by targeting Abeta 42 production.   "
57382|NCT02534467|"     An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16     years assessing effects of Montelukast on moderate to severe atopic dermatitis.   "
57383|NCT02534454|"     The purpose of the phase 1 translational pilot study proposed here is to gather preliminary     data investigating the efficacy of transcranial direct current stimulation (TDCS) and     cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The     recent use of TDCS over task relevant regions to alter behavior holds incredible promise for     use in cognitive retraining intervention protocols. Previous studies of cognitive retraining     have focused on implicit training techniques. This proposed study will attempt to enhance     these implicit training techniques through the use of TDCS during implicit retraining in     order to increase learning of avoidance-related action tendencies towards tobacco. The     objective of this pilot study is to establish the feasibility and obtain preliminary data on     the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette     smoking in individuals with nicotine addiction.   "
57387|NCT02534402|"     In this study, prednisone dose, day/time administration will be controlled in a stable COPD     patient population to determine its effect on peripheral whole blood gene expression. This     data has never been collected in a COPD population using the investigators' chosen platform     for gene expression (Affymetrix Human Gene 1.1 ST). Conducting this experiment is essential     for achieving the broader aims of an already existing and related study titled Clinical     Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management study.     As part of this existing study, blood is being collected from hospitalized and     non-hospitalized COPD patients in order to develop a blood-based biomarker test for the     diagnosis and prediction of acute exacerbation of COPD (AECOPD). The majority of these     patients were administered prednisone as part of standard care for the treatment of AECOPD.     As such, the effect of prednisone on gene expression needs to be ruled out.   "
57388|NCT02534389|"     Neoadjuvant treatment with radiotherapy (RDT) and chemotherapy (CT) are the treatment of     choice for rectal adenocarcinomas in stages II and III. This results currently in pathologic     complete response in 10% to 30% of cases. The immune and inflammatory response is altered in     these individuals and is directly related to response to therapy. Both the disease and the     treatment of colorectal cancer have an impact on quality of life and nutritional status. In     studies with cells and animal models the incorporation of fatty acids eicosapentaenoic acid     (EPA) and docosahexaenoic (DHA) - derived from fish oil - has been shown to interfere in the     process of inflammation, cell signaling and gene transcription enhancing the response to     treatment. Are reported ability to restore the apoptosis of tumor cells, sensitization of     tumor cells to chemotherapy, production of less pro-inflammatory cytokines and the     preservation of normal energy and protein metabolism. The aim of this study is to verify if     the daily consumption of 2.4 g EPA + DHA for adults in neoadjuvant therapy can promote     changes on inflammatory and immunological markers of host response to tumor and if this     response is altered by nutritional status. It is expected that supplementation can reflect in     control of inflammatory and immune response in favor of tumor cell death contributes to     pathological complete response and that it happens with preservation of nutritional status.     Subjects will be randomized as to supplementation. All will be assessed in four moments     during neoadjuvant therapy and immediate postoperative. Results will be presented by     comparing the intervention group and control group at each moment.   "
57389|NCT02534376|"     There is evidence in human studies as well as animal studies that treatments to lower     cholesterol can reduce the risk of dying from prostate cancer.To decide if     cholesterol-lowering therapy can slow the growth of prostate cancer, the investigators would     like to lower cholesterol prior to surgery and then measure the growth of prostate cancers     cells when the prostate has been removed. The investigators will use the combination of two     drugs that is approved by the U.S. Food and Drug Administration to lower cholesterol. The     drug combination is commercially available with a doctor's prescription and sold as Vytorin®.     It is known that maximal cholesterol-lower effects are seen after 2 weeks of treatment with     Vytorin®. Therefore, study patients receive at least 2 weeks, but no more than 6 weeks of     Vytorin® prior to surgery.   "
57390|NCT02534363|"     Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive     deficits are already present at the first break of the illness, seem to remain stable during     early phases and noticeably influence daily functioning. Differences among antipsychotics in     terms of cognitive effectiveness have turned out to be a topic of increasing research     interest. The initially postulated superior neurocognitive effectiveness of second-generation     antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under     debate. Long-term studies would be of great value to evaluate the differential benefits     exerted by antipsychotic drugs on cognitive performance. The aim of this study is to     investigate the cognitive effects of aripiprazole, quetiapine and ziprasidone in     first-episode psychosis at 1 year.   "
57391|NCT02534350|"     This study will evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV)     viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.   "
57393|NCT02534324|"     The current guideline of asymptomatic severe hypertension (ASH) treatment in emergency     department (ED) recommends through low level of evidence that the patients should not be     rapidly decreased their BP in ED but instead receive oral antihypertensive treatment and     close outpatient follow-up is needed. Unfortunately, there was some ambiguity in the time     point of BP measurement in ED described in the past literature because high BP on ED     admission may significantly decrease within hours without any medications. The importance of     pre-ED discharge BP, which can still be critically high, that may affect the follow-up     outcome has never been investigated. The study aim of this study is to evaluate the     physicians' treatment strategies as well as immediate clinical outcomes between patients with     severely- and moderately-elevated pre-discharge BP after management of ASH its in ED during     the recent recommendation. The secondary outcome is to compare the BP at follow-up in these     two groups.   "
57394|NCT02534311|"     The purpose of this clinical trial is to prospectively evaluate RA activity using the     assessment of change in DAS28 under local conditions in Slovakia in participants who are     treated with subcutaneously administered tocilizumab pursuant to the recommendations of the     Ministry of Health of the Slovak Republic in order to better assess the disease activity and     impairment of the joint function.   "
57395|NCT02534298|"     The objective is to study the relation between the reorganization of the central auditory     system, and the psychophysical deficits in binaural hearing in subjects with single sided     deafness.   "
57396|NCT02534285|"     The investigators hypothesize that the noise level in the operating theatre influences the     patients' requirements of anesthetics. Study subject are patients undergoing abdominal     surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural     injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the     inhalational anesthetic desflurane. Desflurane requirements are adjusted using     neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are     randomized to receive hearing protections or not.   "
57400|NCT02534233|"     Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of     various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The     purpose of this study is to assess the safety, feasibility and performance of cryoablation     system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous     dysplasia who need ablation therapy for clinical standard care. The new cryoablation     treatment will be offered as an alternative to standard ablation therapies already in place     (radiofrequency ablation, carbon dioxide cryotherapy).   "
57401|NCT02534220|"     The aim of this study is to evaluate the gingival margin stability with the use of     oscillating-rotating toothbrushes compared to manual toothbrushes.   "
57402|NCT02534207|"     This study will evaluate the relationship between basmisanil plasma concentrations and the     occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5)     subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging     sessions. In the first imaging session, participants will have a baseline Positron Emission     Tomography (PET) scan. In the second imaging session, participants will receive a single oral     dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.   "
57403|NCT02534194|"     In the UK and worldwide many babies are born without carers knowing their gestation as the     mothers will not have had good antenatal care. It is possible to estimate gestation but this     requires a detailed clinical exam. The investigators wish to improve this by using software     analysis to pick out features of the baby (face and foot) to try and estimate the gestation     of the baby once it is born. The investigators will also look explore if the software can     distinguish the normal face or a baby in discomfort.      Good estimation of gestation can result in more targeted management of the baby. The     investigators will capture the images of newborn babies, from a variety of gestations, and     use this dataset to teach the software to estimate gestational age and level of discomfort.   "
57404|NCT02534181|"     The purpose of this study is to evaluate whether a nutritional strategy is effective in     critically ill patients with cancer diagnosed with refeeding syndrome.   "
57405|NCT02534168|"     Pain assessment in infants and toddlers is quite challenging since children in these     populations are nonverbal or preverbal and cannot describe the presence and severity of pain     that they perceive. Over the last decade, advances in the field have included the development     of behavioral scoring systems for the assessment of acute pain . However, although they have     been validated, these commonly used methods of pain assessment are largely subjective and     rely on a highly trained observer. An objective continuous measure of pain would be an     important addition to standard behavioral painscores which require nurses to monitor the     child's behavioral responses.   "
57406|NCT02534155|"     The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients,     who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs.     surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or     Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12     months post-procedure).   "
57407|NCT02534142|"     Approximately 40% of members with a positive fecal occult blood result do not continue to     followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural,     process, carer and patient related causes of undertreatment and suggest appropriate     organisational interventions. Using both quantitative and qualitative methods, the     investigators will identify organisational and personal barriers to completion of followup of     positive FOBT.   "
57408|NCT02534129|"     Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying,     ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing     whole breast radiation.   "
57409|NCT02534116|"     The purpose of this study is to compare outcomes between incisional negative-pressure wound     vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal     surgery.   "
57420|NCT02533973|"     A phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel (calcipotriol     50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with     Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in Chinese     subjects with scalp psoriasis   "
95846|NCT02031588|"     Observational study of the effects of antibiotics on commensal flora. Realization of stool     samples and nasal swabs before and after antibiotic therapy.   "
57410|NCT02534103|"     As considering the close relationship between systolic dysfunction and diastolic dysfunction,     the EAS index e'/(a' x s') including systolic and diastolic function could be expected to     predict hemodynamic changes during off-pump coronary artery bypass surgery(OPCAB). Exposure     of the grafting site during OPCAB needs displacement of the heart, resulting in hemodynamic     instability.      Therefore the investigators are going to evaluate EAS index with preoperative Transthoracic     echocardiography(TTE) and want to know the relationship between preoperative EAS index and     intraoperative hemodynamic changes in patients undergoing OPCAB, in a prospective     observational study.   "
57411|NCT02534090|"     Nowadays feeding intolerance (FI) is a common condition among preterm infants. It has been     estimated that 16%-29% of premature infants admitted to neonatal intensive care units (NICUs)     develop feeding intolerance at some point during their length of stay. The most frequent     signs of FI are the presence of abdominal distension, abundant and/or bilious gastric     residuals and vomiting suggesting an inability of the infant to further tolerate enteral     nutrition, it increases with decreasing in gestational age (GA) and birth weight (BW). FI     represents one of the most uncontrollable variables in the early nutritional management of     these infants, and may lead to suboptimal nutrition, delayed attainment of full enteral     feeding and prolonged parenteral nutrition supply.      NIRS has been used in preterm infants to evaluate changes in cerebral perfusion and     oxygenation. It provides real time insight into the oxygen delivery, presented as regional     oxygen saturation rSO2 with lower values than SpO2 distal pulse-oximetry where is mostly     measured as arterialized capillary bed (around 55% vs 98% Oxygen saturation in regional NIRS     vs conventional pulse-oximetry). Light easily penetrates the thin tissues of the neonate     through bone and soft tissue, particularly the thin capillary bed of the tissues; NIRS     provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.      This technique uses principles of optical spectrophotometry that make use of the fact that     biological material, including the skull, is relatively transparent in the NIR range.      Dave et al. evaluated the abdominal tissue oxygenation with NIRS, and showed that preterm     infants change their cerebral - splanchnic oxygenation ratios during feedings, mainly because     an increasing in the splanchnic oxygenation.      Gay et al. performed abdominal NIRS in premature piglets showing association of     perfusion/oxygen changes with NEC spectrum.      The investigators would like to evaluate the association between feeding intolerance and     unchanged splanchnic regional saturation and variation in the cerebral splanchnic ratio.      Innovation:      FI diagnosis follows a subjective approach, where the clinician is worried in further risk of     develop Necrotizing enterocolitis (NEC). This non-studied relationship (FI and NEC) lower the     threshold for the diagnosis of FI. Furthermore, infants with FI diagnosis commonly are     subject of stop or slow the progression of feedings, increasing the risk of intestinal villi     atrophy, and increase the length of parenteral nutrition support, and also the length of stay     in the NICU settings. If NIRS technology help the clinicians to detect true abnormalities     objectively as a new monitor assessing adequate feeds progress decreasing failure to feed,     and therefore diminishing the need for parenteral feeds and further complication associated     with it.   "
57412|NCT02534077|"     To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated     cholestasis to receive Omegaven for compassionate use situations for which there are no     satisfactory alternative treatments.   "
57414|NCT02534051|"     Clinics will be randomized to the use of the care pathway for obese pregnant women or     standard care. Women who are (1) up to 20 weeks + 6 days gestation into their pregnancy, (2)     are carrying one baby (not twins) that is healthy (no life threatening anomalies) and (3)     have a Body Mass Index ≥ 30 kg/m², will be included. Data will be obtained from the Ministry     of Health's Antenatal Records, charts, and for those in the intervention group, the care path     (filled out by the practitioners - the participants' obstetrician, midwife, or family     doctor). At the end of the study, practitioners will complete a survey, participate in     structured interviews to understand barriers, facilitators, and motivators of using the care     path.      Primary Objective:      To evaluate the feasibility of implementing and testing a clinical care pathway for obese     pregnant women in a pilot cluster randomized controlled trial (RCT)      Secondary Objectives:      To obtain pilot data on A) process outcomes (steps of the pathway, e.g. what % of obese women     receive a screen for diabetes) B) clinical outcomes (e.g. what % of obese women receive a     diagnosis of diabetes), C) provider outcomes (e.g. Is the intervention acceptable, feasible &     efficient? Barriers & facilitators to use, effectiveness? [Structured interviews])   "
57415|NCT02534038|"     Treatment of disinhibition syndrome in participants with Neurodegenrative Disorder.   "
57416|NCT02534025|"     Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to     ameliorate the effect of reperfusion injury in recipients.   "
57417|NCT02534012|"     Elderly patients are usually presented with higher risk for developing cardiopulmonary     complications after general anesthesia (GA). Bilateral paravertebral block (PVB) has been     associated with favorable outcomes in patients undergoing ventral hernia repair. Hence,     elderly patients undergoing major abdominal surgery may benefit from PVB anesthetic     technique.   "
57418|NCT02533999|"     Given the large numbers of children who undergo tonsillectomy (by the time a child is 15     years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity,     and direct and indirect costs associated with absences for child from school or parent from     work or other responsibilities, it is vitally important to identify surgical techniques which     will minimize pain and serious negative outcomes. This study aims to compare a new surgical     technique, PEAK® Surgery System, with electrocautery, one of the most commonly used methods     for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a diagnosis     of sleep-disordered breathing.      In this project, the investigator will evaluate intra-operative outcomes including, surgery     time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption     of normal diet and activity, analgesic type and use, and frequency of emergent visits over 14     days following surgery.      The hypothesis is that there is no difference in outcomes between the traditional     extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced     Peak® Surgery System.      The long-term goal is to minimize pain and risk of bleeding and shorten the time to     resumption of normal eating and activities in children undergoing tonsillectomy.   "
57419|NCT02533986|"     The main objective of this study is to investigate the effect of a 4-weeks intake of berry     peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The     berry peel product will be compared with a placebo in a single-blind, cross-over design.     Furthermore, inflammation-related peripheral blood mononuclear cells (PBMCs) genes     expression, appetite and cognitive performance will be included as a pilot study.     Investigators hypothesize that long-term consumption of polyphenols and fibres of berry peel     will exhibit both direct and indirect actions in healthy overweight subjects by improvement     of glucose-associated markers as well as ameliorating inflammation. Moreover, above metabolic     markers will correlated with improvements in inflammation-related PBMCs genes expression,     subjective appetite and cognitive performance after long-term consumption of berry peel as a     source of polyphenols.   "
59130|NCT02511574|"     The aim of this study is to compare the effectiveness between the cervical pessary and the     natural progesterone in reduction of preterm birth rates in pregnant women with a uterine     cervical length of 25 mm or less evaluated by transvaginal ultrasonography.   "
57421|NCT02533960|"     The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an     investigator-initiated study, is a German multicenter, prospective, observational registry.     It is performed at about 50 certified stroke-units and supported by an unrestricted grant     from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime     is designed to assess the emergency management of acute ischemic and hemorrhagic stroke     patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke:     Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no     anticoagulation.   "
57422|NCT02533947|"     Studies suggest that patients with hematological malignancies undergoing allogeneic     hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and     long-term cognitive dysfunction. To address this issue, a randomized controlled intervention     trial on the effect of physical exercise on cognition is conducted. In addition, the impact     on psychological and physical health outcomes is evaluated. Results may benefit patients who     suffer from disease- or treatment-associated cognitive change.   "
57423|NCT02533934|"     Pilot, open-label study using fixed dose combination of sofosbuvir /ledipasvir to treat     HIV/HCV coinfected pre or post liver transplant participants   "
57424|NCT02533921|"     The purpose of this study is to improve outcomes for persons living with Parkinson's Disease     (PD) and their family caregivers. The investigators hypothesize that outpatient     interdisciplinary palliative care will improve patient-centered outcomes for PD patients at     high-risk for poor outcomes.   "
57425|NCT02533908|"     This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined     with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for     analgosedation for short and painful procedures in children.   "
57441|NCT02533700|"     Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year     PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin,     doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't     demonstrate better response. At present, there is no standardized treatment protocol for this     kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.   "
57426|NCT02533895|"     This is an un-blinded Phase 1 study in which 21 patients suffering from solid advanced     paediatric malignancies (14 sarcoma and 7 non-sarcoma patients) are treated with AV0113, an     anti-tumour immune therapy with autologous Dendritic Cells (DCs) loaded with tumour cell     lysates, in order to investigate its safety and feasibility.      For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue     sarcoma, a long-term (LT) follow-up investigation of the 14 sarcoma patients, which will be     treated using the AV0113 Dendritic Cell Cancer Immune Therapy (DC-CIT) technology is planned,     in order to gather first evidence for a potential LT effect of DC-CIT with AV0113.      Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a cohort     of matched historic control patients that were treated using standard of care will be     conducted. It is planned to analyse 42 historic control sarcoma patients that will be matched     for disease, recurrences, relapses etc.   "
57427|NCT02533882|"     This study will examine the effectiveness of two types of group exercise classes on the     health and functional status in inactive adults age 18-65 with neurological conditions     including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be     randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist     group who will complete a home-based exercise intervention of either Movement to Music or     Adapted Yoga.   "
57428|NCT02533869|"     This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to     differentiate between uncomplicated and complicated acute appendicitis. Differentiation     between the two forms of acute appendicitis is important because according to recent studies     their treatment differs. Complicated forms are still treated operatively, while uncomplicated     forms can be treated conservatively with antibiotics. In the initial phase of the study,     several optimized CT protocols will be created with a phantom model. The two best performing     models will be selected for the second phase of the study, in which patients presenting with     suspected acute appendicitis will be imaged with the two protocols. All patients     participating in the study will be treated operatively, primarily with a laparoscopic     appendectomy. Thus histological confirmation for the diagnosis can be achieved and compared     with the CT images. The goal of this study is to optimize a well-performing low-dose CT     imaging protocol to use in the diagnosis of uncomplicated acute appendicitis.   "
57429|NCT02533856|"     This is a randomized controlled trial to assess the relative effectiveness of providing     Enhanced Transitions of Care (ETOC) to improve patient outcomes after discharge from the     Emergency Department (ED). Patients who are being discharged from the ED and have had a     previous ED visit or hospital admission within the Thomas Jefferson Hospital System (TJUH or     Methodist) within the past 90 days will be eligible for enrollment in this trial. Patients     who consent to enrollment will be randomized to discharge by usual care or discharge with     ETOC as provided by the company BoardRounds.   "
57430|NCT02533843|"     Specific Aim: This prospective randomized study aims to compare the impact of three different     catheter ablation approaches on long-term procedure outcome in terms of arrhythmia recurrence     in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF) patients. The     three strategies to be evaluated are 1) ablation at sources guided by FIRMap (using     RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap + conventional     pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of non-PV triggers     and complex fractionated atrial electrograms (CFAE).   "
57431|NCT02533830|"     The aim of the present study was to evaluate the effect of chewing gum on the recovery of     bowel function after cesarean section in women.   "
57462|NCT02533427|"     This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 fixed-dose     combination (FDC) + GS-9857 on the pharmacokinetics (PK) of a representative hormonal     contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will     assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/GS-9857+GS-9857.   "
57463|NCT02533414|"     In this study, it is aimed to evaluate whether use of a ureteral access sheath (UAS) during     retrograde intrarenal surgery (RIRS) due to kidney stone has any effect on protecting the     kidney functions by measuring blood and urine and Netrin-1 levels.   "
57432|NCT02533817|"     In the UK, people of black West African and Caribbean's tend to have healthier blood     cholesterol and blood fat levels, as well as lower incidence of heart disease/heart attack.     But rates of heart disease are now rising in young African-American populations with     diabetes, for the first time exceeding the rate in their white European-American peers. One     possible culprit is the increasing consumption of fructose which can lead to high blood fat     levels. Fructose is a natural sugar found in fruits and table sugar but is also used the food     industry as an ingredient and sweetener. Because fructose intakes are lower in the UK than in     North America we are studying the effect of fructose intake in UK black West African and     Caribbean people, to understand if fructose intake is indeed a reason for these ethnic     differences.   "
57433|NCT02533804|"     The Lake Nona Life Project aims to examine the health and wellness of participants over the     course of multiple years, focusing on the links between health and wellness, longevity,     quality of life, and human performance.   "
57434|NCT02533791|"     Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14     outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious     outbreak was considered to be a new epidemic strain, with GP homology of the gene was only     97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine     was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry     products which could be stored at 4℃.      In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical     trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe     and robustly immunogenic. One shot of the high dose vaccine could mount glycoprotein-specific     humoral and T-cell response against Ebola virus in 14 days. The investigators intent to     evaluate the safety and immunogenicity of a booster dose of the recombinant Ebola adenovirus     vector vaccine (Ad5-EBOV) in healthy adults after primary immunization in this add in study.     The investigators expect that the boosting immunization with a same vaccine for primary     immunization is possible and could confer a longer-lived protection when needed.      The phase I trial has been unblind 28 days after the primary vaccination, but all the     subjects are still kept blind as well as the laboratory staffs. Therefore, this booster     vaccination trial will be conduct in single blind.   "
57435|NCT02533778|"     A prospective pilot study to evaluate the recanalization and safety of mechanical     thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal     between 8 - 24 hours.   "
57436|NCT02533765|"     This is open-label, single-arm, two-stage phase II trial of olaparib in patients with     relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the     preliminary activity of Olaparib in GCT tumors. The secondary objective is to evaluate the     safety of Olaparib in patients with cisplatin-refractory GCT.   "
57443|NCT02533674|"     Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of     PM060184 in combination with gemcitabine in selected patients with advanced solid tumors.      The study objectives are:      To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected     patients with advanced solid tumors.      To characterize the safety profile and feasibility of this combination in this study     population.      To characterize the pharmacokinetics of this combination and to detect major drug-drug PK     interactions.      To obtain preliminary information on the clinical antitumor activity of this combination.   "
57444|NCT02533661|"     Accumulating data on early intervention for preterm infants in Western countries have     demonstrated short- to medium-term benefits on enhancing child cognitive outcome.     Furthermore, the cumulative plasticity of dopamine-related genes may interact with     environmental intervention in influencing a child's behavior. However, rare studies have     examined the long-term effect of early intervention for preterm infants in Eastern society     and whether the genetic markers interact with environmental intervention in shaping child     developmental outcomes. To meet the contemporary concept of family-centered intervention and     to adapt the findings of our previous studies into program design, we have developed a     family-centered intervention program (FCIP) for preterm infants with very low birth weight     (VLBW, birth weight <1,500 g) in Taiwan and employed a multi-centered, randomized controlled     study design to examine its short-term effects with respect to a usual care program (UCP) and     its biosocial pathways.The FCIP contained ecologically pervasive child-, parent- and     dyad-focused services that lasted from hospitalization until 12 months; the UCP contained     child-focused services in hospitalization and phone calls after discharge. This three-year     multi-centered study is therefore aimed to extend our research to examine the long-term     effectiveness of FCIP on child and parent outcome compared to a usual care program (UCP) for     VLBW preterm children in Taiwan at preschool age and to investigate if dopamine-related genes     moderate intervention effect on child developmental outcome. A total of 270 VLBW preterm     infants have been enrolled and randomly assigned to the FCIP and UCP, and their buccal cells     samples have been collected for typing of dopamine-related genes. All infants and families     will be examined at 3 and 4 years of age for child and parent outcomes. Child outcomes will     include growth, health, cognition, language, motor function, and behavioral measures; parent     outcomes will consist of parental stress and quality of life measures. The long-term effect     of early intervention for preterm infants will provide important information to help     medical/educational professionals and public policy makers develop and assess effective     intervention for Taiwanese preterm children who are at risk of developmental disorders.     Furthermore, the results will help reveal the gene and intervention interaction on child     developmental outcome.   "
57445|NCT02533648|"     Our recent data in mice have demonstrated a key role of xanthine oxidase in     hyperglycemia-induced by Reactive oxygen species production, and a preventive role of     allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and     structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical     trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial     alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2     diabetic patients.   "
57446|NCT02533635|"     This is a single-blind, cross-over pilot study to observe the safety and efficacy of     Ganoderma tea on eczema patients.   "
57447|NCT02533622|"     Despite the known complications of immobility for ICU patients, compliance to mobility     protocols is lacking in many institutions. Significant barriers have been described to     compliance to up in chair and weight bearing orders in the ICU. Recent studies indicate that     if progressive mobility is performed for acutely ill ICU patients they may have a reduced ICU     length of stay, reduced overall hospital length of stay, incur lower hospital costs, and     reduce the rate of some medical complications and increase functionality post ICU discharge.      The current protocol seeks to understand whether or not the TotalCare® P500 Bed System and     the Liko Lift can remove some of the barriers associated with progressive mobility     compliance.   "
57464|NCT02533401|"     This study will evaluate the efficacy and safety of rituximab in combination with     chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.   "
57773|NCT02529345|"     The objective of this clinical investigation is to evaluate the clinical outcome (up to 12     months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high     risk for carotid endarterectomy requiring carotid revascularization due to significant     extra-cranial carotid artery stenosis.   "
57448|NCT02533609|"     Acute kidney injury requiring renal replacement therapy is common in critically ill patients.     The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic     treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal     replacement therapy is applied using continuous techniques. In recent years, the efficacy of     renal replacement therapies has improved, namely by using regional citrate anticoagulation     which improves filter lifetime and filter patency. At present, the extent of removal of     antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been     investigated thoroughly. Thus, the investigators want to investigate        1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and          imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se        2. whether filter patency during citrate-anticoagulated CVVD remains stable during a          treatment period of 72 h   "
57449|NCT02533596|"     Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal     of pathophysiological relevant mediators in various diseases. Adipokines have recently been     found to play an important role in a variety of immunologic diseases. However, in many of     these disease states cardiac and inflammatory involvement is common and biomarkers are     routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on     biomarkers used in the clinical routine has not been investigated. The aim of this study is     to determine adipokine and cardiac biomarker removal during TPE therapy.   "
57450|NCT02533583|"     The investigator assessed the feasibility and reliability of pulse oximetry plus clinical     observation for detection the lung disease in neonates.   "
57451|NCT02533570|"     The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin     in adults with active systemic lupus erythematosus (SLE).   "
57452|NCT02533557|"     The supraclavicular block can provide effective surgical anesthesia of the forearm and hand.     There have been many different approaches to ultrasound-guided supraclavicular brachial     plexus block (US-SCBPB) according to the needle injection site (e.g. corner pocket approach,     cluster approach) or number of needling (single or double injection). Numerous studies     demonstrates good results (e.g. faster onset time) when using double injections rather than     single injection. But double injection does not guarantee complete sensory block because     ulnar nerve tends to be spared by its anatomical location.   "
57453|NCT02533544|"     This is an open-label, single arm cohort study to see efficacy and safety of tenofovir     disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively     both.   "
57454|NCT02533531|"     This study is intended to assess the feasibility and usability of the 1 Lead Patch as a     whole, on patients outside the hospital, in the out-patient setting.   "
57475|NCT02533258|"     This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern,     safety and effectiveness in Taiwan real world routine practice. The primary objective of this     registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The     secondary objectives include safety profile, objective response rate, and progression-free     rate in real world routine practice.   "
57455|NCT02533518|"     Diagnose lung cancer at an early stage is crucial for effective treatment. At these early     stages, cancer is usually invisible in ambient white light when the endoscopic analysis of     the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light.     These widely distributed autofluorescence methods detect early mucosal abnormalities. They     are very sensitive but not specific to recognize the lung cancer. Thanks to European funding     (EURIMUS), a new tool with fluorescent UV light has been developed.      The purpose of this preliminary study is to verify the suitability for specific detection of     cancerous tissue in Pneumology of this fluorescence method versus histological analysis of     the tissue.   "
57456|NCT02533505|"     A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects     with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after     administration of Symbicort pMDI 160/4.5 μg.   "
57457|NCT02533492|"     Total knee replacement is now one of the most popular reconstructive procedures for the     elderly people to regain their functional capacity and life quality. However the reported     incidence of postoperative infection or surgical site infection after total knee replacement     has been around 1 to 2 percent. The cost and expenditure for treating periprosthetic     infection are high and the results are often detrimental to the patients who suffered from     the complication. To decrease the wound healing complication related to the contamination of     bacteria, an antibacterial suture was used successfully in some clinical settings and in     animal experiments. Whether the antibacterial suture material could be used in patients with     total knee replacement has not been addressed in the past. The investigators therefore     propose a prospective randomized double-blinded study to investigate the efficacy of an     antibacterial suture material in total knee replacement. The inclusion criteria are patients     with degenerative osteoarthritis without previous surgery to the index knee. Patients who     have inflammatory arthritis such as rheumatoid arthritis, who have neurovascular disease of     the lower extremities, who have history of liver cirrhosis or under hemodialysis for renal     failure are excluded. One hundred and two patients will be randomized to study group (51     knees) and control group (51 knees) in a period of 12 months. All cases will follow the     standard protocol based on clinical pathway. Antibacterial suture material (Vicryl Plus,     Ethicon) will be used in the study group and regular suture material (Vicryl, Ethicon) will     be used in the control group. Preoperatively, the skin condition (digital photo and image     analysis),laser Doppler study, inflammatory markers (CRP/ESR/IL-6), functional score (KSS:     Knee Society Score; SF-12: Short Form 12), and VAS score will be assessed. Operative data of     operation time, blood loss and wound classification are recorded. Postoperatively, the skin     condition (digital photo and image analysis), skin temperature, inflammatory markers, KSS,     and VAS will be assessed on 1st and 3rd postoperative day, 2 weeks, 4 weeks, and 3 months.   "
57458|NCT02533479|"     The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles     in adult healthy human after caloric restriction and acute exercise in order to validate     erythrocyte FAs profile as marker of changes in muscle fatty acid composition.   "
57459|NCT02533466|"     This exploratory study is designed to help develop a clinical model to measure the earlier     stages of dietary acid medicated enamel loss. The study will use fluoride as positive control     to explore the validity of this design.   "
57460|NCT02533453|"     As current study is conducted to provide additional information regarding safety and efficacy     Bydureon, exenatide once weekly for injectable suspension, in the Korean population open     label, non-comparative, multi-centre design is used.   "
57461|NCT02533440|"     This study is researching managing postsurgical pain by injecting both short-acting local     anesthetics and EXPAREL® at the time of surgery and reviewing if it could reduce or eliminate     the need for postsurgical opioids and improve clinical outcomes following the FAST dental     implant surgery procedure. This approach is being compared to the current standard of care.   "
57465|NCT02533388|"     Elderly patients have an increased risk of stress responses during extubation after general     anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses     during extubation after general anaesthesia remains challenging for the anaesthesiologist. In     this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation     (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly     patients who underwent elective supratentorial craniotomy under general anaesthesia.   "
57466|NCT02533375|"     The primary objective is to investigate efficacy, safety and pharmacokinetics of adalimumab     in Japanese subjects with generalized pustular psoriasis (GPP).   "
57467|NCT02533362|"     A 6 month safety, tolerability, efficacy and pharmacokinetic study with ANF-Rho to treat     patients with chronic neutropenia.   "
57468|NCT02533349|"     Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD)     (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies     had several problems including inclusion criteria, randomization methods, and placebo     medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had     synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the     efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed     randomized double blind case-control study.   "
57469|NCT02533336|"     Over one year period in an area with universal coverage of LLIN and ACT provision as the     first-line treatment of malaria, the investigators intend to evaluate the impact of DL on     malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of     moderate to severe anemia, and entomological parameters. Information on the relative     cost-effectiveness estimates of DL and the community acceptability of DL will also be     measured.   "
57470|NCT02533323|"     This prospective study was conducted to evaluate the efficacy and safety profiles of     first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed,     nasal type, extranodal natural killer/T-cell lymphoma.   "
57471|NCT02533310|"     The aim of this study is to examine the efficacy of virtual reality exposure therapy as a     treatment for specific phobia (spiders). A gamified virtual reality simulation of one-session     therapy (VR-OST) will be compared to the gold-standard treatment in the form of traditional     one-session phobia treatment (OST) using in-vivo stimuli. This study was powered to detect a     non-inferiority margin of a 2-point difference between groups.   "
57476|NCT02533245|"     The primary aim is to evaluate the short- and long-term effect of the 'Transplantoux'     exercise training intervention in solid organ transplant recipients with matched control     sample of transplant recipients in view of selected Patient Reported Outcomes (PRO), i.e.     health-related quality-of-life (HRQOL), psychosocial and behavioral variables, using a     quasi-experimental design.   "
57477|NCT02533232|"     This a randomized double-blind placebo controlled trial which aims to determine the     beneficial effects of minocycline augmentation to clozapine in partial responders to     Treatment Resistant Schizophrenia (TRS).   "
57478|NCT02533219|"     The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide     improved presurgical planning and distinguish between focal and diffuse forms of HI. The     investigators will perform descriptive analysis, relying on visual analysis to diagnose and     localize a focal lesion. Our findings will be compared to surgical histopathology to     determine sensitivity and specificity or this technique. The investigators will also track     patient surgical outcomes, specifically whether the patient is surgically cured or still     requires medical management to control residual hypoglycemia.   "
57479|NCT02533206|"     Chronic sinusitis is one of the most common chronic diseases in North America, with over 5%     of the Canadian population affected by the disease. Until now, treatment with surgery has     been performed only in the operating room. Recently a smaller surgical procedure that is done     in the clinic for some patients with chronic sinusitis with polyps has been found to result     in symptom control that appears to be similar to that which occurs with sinus surgery.     Performing the smaller clinical procedure has advantages including a shorter recovery time     for the patient, a much lower cost to the health care system for the procedure, and a shorter     patient wait time for the procedure to be done in comparison to sinus surgery performed in     the operating room. To know with greater certainty that the procedure performed in the clinic     is as good as the operating room sinus surgery, a large multiple investigator randomised     clinical trial has been designed. However, before carrying out that trial, a practice run or     internal pilot study of that trial is required to ensure that the trial can recruit patients     at the rate that is anticipated and that the procedures to obtain the measurements being used     for the larger study are adequate.   "
57480|NCT02533193|"     The purpose of this study is to investigate the clinical value of enhanced recovery after     surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days     comparing with traditional care .   "
57481|NCT02533180|"     The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte     phenotype of immune senescence or exhaustion is different between operationally tolerant and     non-tolerant liver allograft recipients.   "
57482|NCT02533167|"     Early skin to skin contact has beneficial effects and is part of the Healthy Birth     Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose     control, and temperature has been demonstrated. It is the standard of care for vaginal     deliveries but surgery is a barrier in its initation in the operating room. This study is     evaluating initiating skin to skin contact as soon as feasible in the operating room.     Informed consent will be obtained from scheduled/non emergent cesarean sections who are of     EGA.37 weeks who are ASA I-II and receiving the standard spinal anesthetic. Skin to skin     contact will be initiated after delivery as soon as apgars and newborn assessment has been     completed. Goal is a minimum of 60 minutes of skin to skin contact between the mother and the     newborn, with the only interruption being upon movement from the OR table to the stretcher     when leaving the OR. Subjects seen post delivery day 1 for assessments of pain and maternal     satisfaction utilizing a sliding 100mm VAS assessment tool.   "
57774|NCT02529332|"     Omega-3 supplementation has been shown to have neuroprotective and potentially     anti-inflammatory properties in both central and peripheral nerve injuries. The investigators     are studying to see if omega-3 supplementation will affect olfactory (smell) function in     patients with olfactory dysfunction following endoscopic removal of pituitary tumors.   "
57483|NCT02533154|"     Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of     topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial     spectrum, it has also been shown to induce toxic effects to the ocular surface. Several     studies have indicated that BAC may also have altering effects on the bacterial flora of the     conjunctiva.      Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular     surface and the tear fluid resulting in tear film instability, inflammation of the ocular     surface, symptoms of discomfort and visual impairment, there are many different preserved as     well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of     DES. Unpublished data from our department shows differences between artificial tears for the     treatment of DES with and without BAC in bacterial culture.      Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops     with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or     moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study     will be recruited and treated either with the preservative-free Prosicca sine eyedrops or     the BAC containing Prosicca eyedrops for one month. Conjunctival samples will be collected     of one eye of each patient before and after the 1-month treatment period to compare the     conjunctival bacterial flora of the two treatment groups.   "
57484|NCT02533141|"     Statins are drugs representing the most commonly prescribed medication for the treatment of     hypercholesterolemia. In a recently published study, discontinuation of statin therapy in     patients after acute myocardial infarction was associated with a higher all-cause mortality     (hazard ratio 3,45) and a higher cardiac mortality (hazard ratio 4,65). Increasing evidence     suggests that statins also have vasoactive properties by up-regulating endothelial nitric     oxide synthase (eNOS) with positive effects on endothelial function. Experiments with     flow-mediated vasodilatation (FMD) showed these positive effects of statin treatment on     endothelial function but also revealed that withdrawal of statin treatment transiently     worsens endothelial function, independently of serum cholesterol levels.      Consequently, this placebo controlled Phase IV crossover study wants to assess changes of     endothelial function in terms of flicker induced vasodilatation before and during statin     therapy as well as after statin withdrawal. For this purpose 20 healthy subjects will be     treated with 40 mg/day of simvastatin for a period of 4 weeks. Flicker induced vasodilatation     and retinal oxygen saturation will be measured with the Dynamic Vessel Analyzer system by     Imedos at baseline, in the 4th week of simvastatin or placebo intake as well as 3, 7 and 14     days after the end of intake.   "
58649|NCT02517905|"     This is a Phase 3, randomized, double-blind, placebo-controlled study in subjects scheduled     to undergo elective bilateral third molar extraction under local anesthesia. At least one     lower mandibular third molar must involve full or partial bony impaction confirmed by visual     or radiographic evidence.   "
57485|NCT02533128|"     Major adverse cardiovascular events (MACE) are a leading cause of serious complications and     death following major noncardiac surgery. The heart biomarkers brain-type natriuretic peptide     (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk of surgery     - low values may permit identifying patients at a very low risk of postoperative     complications, potentially helping to avoid unnecessary tests and delays prior to surgery.      Recent studies suggest that the manner in which an anesthetic is conducted may have an     important impact on postoperative outcomes. The combination of low blood pressure (BP) and a     deep level of anesthesia despite a low dose of anesthetic - also known as a triple low -     has been linked to increased complications and death following surgery. However, it is     unclear whether triple lows actually cause postoperative complications or whether they are     merely an indicator of a sick patient, who is in general more likely to suffer from     cardiovascular events in the near future. To answer this question, in this study patients     will be randomly assigned to groups with lower and higher blood pressures, and the     postoperative rates of major adverse cardiovascular events and of relevant increases in     hs-TnI (a marker of cardiac injury) compared.      Another important question is that of the optimal blood pressure target during surgery.     Currently there are no established methods of tailoring blood pressure management to the     individual patient. In the study the investigators will perform ambulatory 24h BP     measurements prior to surgery to measure the patients' average BP during sleep. In the     analysis of the study data, the investigators will try to determine the relationship of     preoperative biomarker levels, intraoperative BP (both in relation to fixed targets and to     the patient's own night-time BP) and of anesthetic depth with the occurrence of major adverse     cardiovascular events after surgery.   "
57486|NCT02533115|"     This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary     acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.   "
57487|NCT02533102|"     This study is designed to first evaluate the effect of food on E7050's pharmacokinetic     parameters following the administration of single 100 mg oral doses of E7050 tablet to each     normal healthy participant in the study (Part A), and second to characterize E7050     pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B).     Part A will be a randomized, single-dose, open-label, three-treatment period crossover study.     Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve     participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted     conditions. Following review of safety data of the 200 mg dose level, an additional 12     subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.   "
57488|NCT02533089|"     Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly     employed strategy to address the global shortage of skilled health workers. Despite     availability of effective treatment, tuberculosis (TB) remains an important cause of     mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new     TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In     response to the combined high TB burden and severe healthcare worker shortages in these     settings, outpatient TB care is among the tasks commonly shifted to LHWs.      LHWs are community members who have received some training but are not healthcare     professionals. Randomised trials show LHWs improve access to basic health services and TB     treatment outcomes, however, insufficient training and supervision are recognized barriers to     their effectiveness.      The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and     evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of     evidence into LHW practice. The investigators will employ a mixed methods design including a     pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and     qualitative methods to understand barriers and facilitators to scalability and sustainability     of the program.   "
57800|NCT02528994|"     This study will test the effect of short-term, high-dose dietary serine supplementation on     circulating levels of serine. Individuals with risk factors for type 2 diabetes will be     recruited into the 2 week study. Effects of dietary serine supplementation on glycemic     measures will also be explored.   "
57489|NCT02533076|"     Cystinosis is a rare autosomal recessive disorder, characterized by the abnormal accumulation     of cystine in the lysosomes. Cystinosis is mostly caused by mutations in the cystinosin gene     (CTNS). The major mutation, which is present in almost 50% of the cystinosis patients, is a     57-kb deletion. This deletion removes the first 9 exons and a part of exon 10 of the CTNS     gene. Exon 10 of the CTNS gene is a upstream 5' region that encodes for the CARKL gene and     also for the first two noncoding exons of the transient receptor potential channel, vanilloid     subfamily member 1 (TRPV1) gene.      TRPV1 belongs to the transient receptor potential (TRP) superfamily of cation channels. TRPV1     is primarily expressed in sensory nerves and is activated by heating (>43°C) and a wide range     of chemical stimuli. One of these chemical stimuli is capsaicin, the pungent ingredient in     hot chilli peppers. The effect of binding of the exogenous ligand capsaicin with the TRPV1     receptor is well known to provoke the release of a number of bioactive substances including     calcitonin gene-related peptide (CGRP). These substances, in turn, act on target cells in the     surrounding tissue such as mast cells, immune cells and vascular smooth muscle cells. The     resulting response is characterized by redness and warmth (secondary to vasodilatation),     swelling (secondary to plasma extravasation) and allodynia (i.e. hypersensitivity to heat and     touch secondary to alterations in the excitability of primary sensory neurons).      The present study wants to test the following hypotheses:      (i) The DBF response to topical applied capsaicin is decreased in cystinosis patients,     compared to matched control subjects.      (ii) The skin sensitivity response after topical applied capsaicin is decreased in cystinosis     patients, compared to matched control subjects.      (iii) The temperature sensitivity is decreased in cystinosis patients, compared to matched     control subjects.   "
57490|NCT02533063|"     This proposed prospective study will evaluate whether a novel exercise approach, seated     vibration therapy, can improve function in the target population of older adults. Therefore,     the primary aim of this pilot is to examine the effect of vibration therapy on muscle     function (balance, muscle power and strength) and muscle mass.   "
57491|NCT02533050|"     The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients     victims of a coronary artery disease (CAD) (myocardial infarction, revascularization). Unlike     patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic     patients do not complain in their daytime functioning. The objective of this study is to     explore whether the objective cognitive assessment measures may be a good marker of the     efficacy of CPAP treatment given to non-sleepy apneic CAD patients.      Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after     randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients     should have a positive impact on cognitive performance, particularly on attention span and     working memory measured by improvement in the Paced Auditory Serial Addition Test score     (PASAT score).   "
57502|NCT02532907|"     This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC     Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to     determine the effect of new DAA therapies on HCV-related responses in the liver and     peripheral blood.      The introduction of new DAAs regimens that do not include IFN provides unique and novel     opportunities to examine whether successful treatment-induced eradication of viral antigen     results in reconstitution of T cell immunity. serum and liver tissue samples will be     collected and stored in hopes of improving treatment and outcomes for future patients.   "
57634|NCT02531152|"     Primary Objective:      To assess the local and systemic safety and tolerability of ascending repeated topical doses     of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension     (OHT) as compared to latanoprost.      Secondary Objective:      To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in     patients with OAG or OHT as compared to latanoprost.   "
57492|NCT02533037|"     This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic     ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI     have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes     are used clinically and may improve neuromuscular control by increasing lower extremity     muscle activation, which may improve gait patterns. The investigators' purpose is to     determine whether a 4-week rehabilitation program that includes ankle destabilization shoes     (experimental) has beneficial effects on self-reported function and ankle gait kinematics     compared to traditional rehabilitation without destabilization shoes (control) in CAI     patients. In addition, the investigators will compare ankle strength and balance between CAI     patients and healthy individuals with no history of ankle injury prior to the 4-week     rehabilitation. The investigators hypothesize the experimental group will have greater     improvement in self-reported function and frontal and sagittal plane kinematics during     walking compared to the control group. In addition, the investigators hypothesize that     patients with CAI will have a decrease in ankle strength and balance when compared to healthy     individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients     will complete baseline self-reported function questionnaires and walking gait trials and then     be randomized into control and experimental groups. Both groups will complete 4-weeks of     supervised rehabilitation with or without destabilization shoes and then repeat the     questionnaires and walking trials.   "
57493|NCT02533024|"     This study is to investigate the incidence of undiagnosed ulnar neuropathy in patients     undergoing surgery. The investigators hope to determine if patients with ulnar neuropathy     have changes in nerve conduction latency during surgery.   "
57494|NCT02533011|"     Present criteria used to define sepsis are non-specific, making it difficult to both     distinguish sepsis from other diseases and to predict which patients are likely to become     more severely ill. In standard care, patients at risk of becoming more severely ill are     neither identified nor indicated for resuscitative efforts until they develop hemodynamic     insufficiency or organ failure; after progression to severe disease, mortality increases     significantly. The identification of risk patients can lead to earlier initiation of     resuscitation therapies and potentially lead to reduced morbidity and mortality. This study     aims to determine whether Heparin-binding protein (HBP), which is secreted from neutrophils     during infection and a mediator of vascular leakage, can act as a biomarker for the     progression to severe sepsis with circulatory failure.      The objective of this study is to validate the utility of HBP to predict the development of     delayed onset organ dysfunction in sepsis in patients and to compare the performance of HBP     relative to currently used prognostic biomarkers in sepsis.   "
57495|NCT02532998|"     This is a Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics     of AZD9977 following Single-Dose administration to healthy male subjects   "
57508|NCT02532829|"     The HIPER-1 study is a single centre cross sectional study in which a total of 240     participants (in different metabolic states and surgical models) will receive an Oral Mixed     Meal Tolerance Test (OMTT). At baseline and after 30, 60 and 120 minutes the PYY levels,     GLP-1 levels, glucose and insulin sensitivity will be measured. The primary endpoint of the     study will be the area under the GLP-1 and Peptide - YY curves and insulin sensitivity     following the OMTT.   "
57496|NCT02532985|"     The study will assess the gastrointestinal tolerability of multiple servings of a novel     dietary fiber at three different dose levels in generally healthy men and women. Double-blind     controlled, cross-over clinical trial with negative (no added fiber) and positive controls.     Multiple servings over 24h, with data collection at 24 and 48h and 1 week wash-out between     cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI higher or equal to     18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control     will be delivered in 240 ml beverages.   "
57497|NCT02532972|"     This is a research study to determine whether a cochlear implantation (CI) device can improve     hearing in people who are deaf in one ear (known as single-sided deafness).   "
57498|NCT02532959|"     Analysis of exhaled breath samples using a high-speed gas chromatography medical device will     identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and     Sepsis.      Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis     System, which includes high-speed gas chromatography, in the early detection of SIRS and     Sepsis as compared with current SIRS and Sepsis evaluation methods.   "
57499|NCT02532946|"     This is a mixed methods study, incorporating a randomized controlled trial and a qualitative     provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in     patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting     reversible contraception in women seeking induced abortion.   "
57500|NCT02532933|"     The overall purpose is to compare the kinematics and mechanics of medialized dome and     anatomic resurfacing through measurement and simulation, and to correlate these findings with     patient satisfaction and performance.      Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs     using stereo radiography and correlation with patient function as measured by Knee injury and     Osteoarthritis Outcome score, Knee Society score, and strength.      Hypothesis: the anatomic patellar implant will have significantly greater sagittal flexion     than the dome implant.      Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact     mechanics and loading through the use of subject-specific simulation.      Hypothesis: quadriceps efficiency and moment arm will be greater for the anatomic patellar     implant, while loading between the patellar and femoral components will be reduced.   "
57501|NCT02532920|"     Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is     increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD     is diagnosed by clinical as Hanifin and Rajka criteria. There are 3 group of severity defined     by SCORAD(Scoring Atopic Dermatitis) : mild (<25), moderate (25-50) and severe (>50). The     natural history of AD was mentioned in 3 groups: complete remission, persistent and     intermittent. Atopic march is the progression of atopic disease that has atopic dermatitis as     the first manifestation then patients will have allergic rhinitis or asthma in the future.     The investigators do a retrospective study to understand the natural history of AD as well as     it associate with atopic march. That might be a predictive factor of AD and atopic march   "
57528|NCT02532569|"     A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and     safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj.     and to conduct an exploratory investigation on vaccine interchangeability in Korean children     aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC®     inj.   "
80525|NCT02231905|"     Study to assess the safety, tolerability and effectiveness of a switching from Domin®     (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease   "
57503|NCT02532894|"     We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function     measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon     either activation or apoptosis from different cell types such as platelets, leucocytes and     endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the     blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells     are inversely correlated to cardiovascular risk factors.      As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation     marker used in asthmatic patients - after inhalation of electronic cigarette vapor.   "
57504|NCT02532881|"     The purpose of this study is to determine the effect of an internet-based preparation on the     outcome expectancy and treatment credibility of rehabilitants concerning inpatient     psychosomatic rehabilitation. Both study groups receive the usual written information for     preparation (TAU). The patients of the experimental group have access to various videos on     the study website until their inpatient rehabilitation begins, the patients of the placebo     group receive no special treatment. The investigators hypothesize that the experimental group     gains more positive outcome expectancy and treatment credibility compared to the control     group.   "
57505|NCT02532868|"     The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an     Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the     oral formulation will also be assessed. The primary study hypothesis is that administration     of MK-0457 is sufficiently safe and tolerated to permit further study.   "
57506|NCT02532855|"     The purpose of the study is to assess the effect of the addition of sitagliptin to metformin     with or without a sulfonylurea compared with the addition of dapagliflozin to metformin with     or without a sulfonylurea on hemoglobin A1c (A1C) over 24 weeks of treatment as well as the     overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin after     24 weeks of treatment. The primary hypothesis is that the change from baseline in A1C in     participants treated with the addition of sitagliptin is non-inferior compared to that in     participants treated with the addition of dapagliflozin after 24 weeks of treatment.   "
57507|NCT02532842|"     The primary objective of this study is to explore hospitalization (number, length and reasons     for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants     during the first 12 months of treatment with once monthly paliperidone palmitate in     naturalistic clinical settings.   "
57509|NCT02532816|"     The purpose of this study is to determine and compare the effect of higher nutrient-dense     complementary foods and standard nutrient dense complementary foods on the catch-up growth     and nutritional status of stunting children aged 12-23 months old in Indonesia.   "
57510|NCT02532803|"     Early cancers of the rectum can be removed safely through the anus without subjecting     patients to major abdominal surgery in a procedure called TEMS (transanal endoscopic     microsurgery). Patients undergoing TEMS can benefit from reduced mortality, impotence,     hospital stay and avoiding a stoma that may be associated with pelvic surgery.      Currently few of the patients eligible for TEMS are offered it for a variety of reasons that     include uncertainties about the risk of leaving residual tumour and the increased risk of     subsequent recurrence of cancer within the pelvis. Current UK guidelines state there is no     role for imaging in assessing the malignant polyp. Conversely whilst retrospectively     reviewing their MRI databank the investigators have found evidence that MRI can accurately     judge the depth of these early tumours and thereby potentially identify patients for local     excision.      The investigators hope to prospectively test their hypothesis that an MRI scan can accurately     gauge depth of tumour spread in an unselected group of benign and malignant tumours measuring     between 20mm and 50mm in size.      The investigators will identify eligible patients awaiting surgery / polypectomy and if they     consent to this pilot study participants will undergo an MRI to assess their tumour which     assesses safety at all levels of the rectal wall. The accuracy of MRI can then be established     by reference to gold standard histopathology. Should MRI prove sensitive and specific then     the investigators hope to change national guidelines to mandate MRI to standardise assessment     and thereby increase the appropriate use of TEMS in the UK.   "
57511|NCT02532790|"     This study is performed to evaluate the efficacy and safety of various measures in the     treatment of HSPN with mild proteinuria in children.   "
57512|NCT02532777|"     This study is performed to evaluate the efficacy and safety of various measures in the     treatment of HSPN in children.   "
57513|NCT02532764|"     A randomized, double-blind, placebo-controlled study of single and multiple ascending doses     of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.   "
57514|NCT02532751|"     The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish     version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery     using patient-reported outcome measures.   "
57515|NCT02532738|"     The investigators' preliminary study indicates that MSC is effective therapy in treating IBD.     But the standard treatment is still lacking and the effect is not stable in IBD patients.     This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.   "
57529|NCT02532556|"     Blood is aided on its journey to the heart by the action of the muscles of the legs. Muscle     contraction squeezes the deep veins of the leg and pushes blood upwards, back towards the     heart. In immobilised patients, or those with blood vessel problems, the pumping process can     be helped by machines that either squeeze or shock the muscles of the calf (e.g. intermittent     pneumatic compression, electrical stimulating devices). Many are licensed for medical use,     and some are common place in hospitals and outpatient departments.      Objective: The most efficient way of electrically stimulating the calf muscles has not been     identified. The investigators aim to investigate this using a matrix of electrical     parameters, and measuring the outcome with vascular ultrasound of the leg.   "
57516|NCT02532725|"     Obesity is associated with many undesirable health effects and disease, and middle age is     associated with increased risk for disease. Unfortunately, while others have looked at the     effects of obesity, gender, and middle age, the combined effects of obesity and middle age on     men's ability to do work in hot industrial environments have not been satisfactorily     investigated.      This small study evaluates the heat tolerance of lean and obese middle aged men both while     exercising and resting and the ways in which each compensate for and dissipate increasing     environmental heat and heat generated by the body while exercising.      As obesity is a worldwide public health crisis and as populations in many industrialized     nations age, it is important to understand the combined effects of obesity and middle age for     men on their ability to safely work in hot environments. Such information will permit     establishing and revising of safe work standards and inform public health outreach to the     target population, itself.   "
57517|NCT02532712|"     This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple     Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and     pharmacokinetics of single-dose and multiple-dose oral administration of the investigational     product, EC-18 (study drug) in healthy adult male volunteers.   "
57518|NCT02532699|"     This the first report undertaken to assess the effect of supplementation with oral     gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood     pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks     could successfully reduce mean diastolic and systolic BP through the suppression of PRA that     is linked to downstream suppresion of angiotensin II formation, which further decreases the     sympathetic outflow that leads to hypertension. In addition to blood pressure lowering     properties, AC mycelia also has beneficial effect in reducing oxidative stress,     significantly. No adverse events were noted, suggesting that AC mycelia deserve its     consideration as a candidate for safe alternative treatment to conventional anti-hypertensive     medications.   "
57519|NCT02532686|"     Pharmacotherapy for schizophrenia has limitations such as residual positive and negative     symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still     a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA)     hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino     acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to     examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant     schizophrenia patients in a randomized, double-blind, placebo-controlled trial.   "
57520|NCT02532673|"     The purpose of this study is to determine whether HIV patients on Atazanavir who have     Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.   "
57521|NCT02532660|"     Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram +     Trichilia catigua Dry Extract (LABCAT TCJUSS) in the average alteration on depression score     measured by the Hamilton Scale (HAM-D).   "
57522|NCT02532647|"     A prospective, double-blind, randomized, placebo and active controlled, multi-center,     parallel group study comparing remimazolam to placebo, with an additional open-label arm for     midazolam, in ASA Grade III and IV patients (ASA status evaluated by an anesthesiologist not     otherwise involved in the study) undergoing a colonoscopy for diagnostic or therapeutic     reasons.   "
57524|NCT02532621|"     This study is a prospective multicenter evaluation of the performance of the InterGraft     System for anastomosis of a hemodialysis graft. The InterGraft System includes an arterial     InterGraft (AIG) connector and a venous InterGraft (VIG) connector used with a standard     arterial-venous (AV) graft. The study is intended to demonstrate that the 6 month cumulative     patency of grafts connected with the InterGraft Connectors is similar to that of grafts     connected using standard sutured anastomoses. In addition, the study will also include a     separate cohort of up to 25 subjects in whom the VIG is used for the venous anastomosis,     together with a standard sutured arterial anastomosis, in situations where the target artery     is not suitable for use of the AIG.   "
57525|NCT02532608|"     In this study the investigators plan to systematically characterise infra-slow EEG     oscillations during sleep, explore their relationship to the microstructure of sleep, and     investigate its role in the physiology and pathophysiology of sleep by co-registration of     Full band EEG with polysomnography during wake and sleep in healthy subjects, after sleep     deprivation, and in patients with restless legs syndrome/periodic leg movements during sleep     (RLS/PLMS).   "
57526|NCT02532595|"     Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the     American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry     needling is effective in reducing pain in several body regions, but no published (TDN)     studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is     to investigate whether a treatment program performed including TDN, manual therapy and     exercise will result in a significant improvement in pain, strength and function compared to     a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects     with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise     will demonstrate a significant improvement in pain, strength and functional outcomes compared     to the group that receives manual therapy and exercise.   "
57527|NCT02532582|"     The purpose of this study is to ultimately prevent injuries to nerves during surgical     procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver)     patients will receive an arterial line as standard of care. The arterial line helps monitor     blood pressure along with the compression of important vessels during surgery. In addition,     research participants will undergo neuromuscular monitoring using Somato-Sensory Evoked     Potential (SSEP) or Evoked Potential Assessment Device (EPAD). During an operation,     neuromuscular monitoring can tell doctors if the nerves being studied are working normally or     if they are at risk for injury. This study will help investigators to understand what kind of     monitoring is best to prevent nerve injuries during a surgical procedure.   "
57549|NCT02532283|"     The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in     combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to     adults (aged 18 to <= 64 years) with influenza A infection.   "
57530|NCT02532543|"     This study is intended to provide statistically robust evidence that Symbios Demineralized     Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with     Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during     ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the     overlying soft tissues. Additionally, a comparison between each material will be made,     providing further evidence of each materials' ability to preserve the alveolus. It is     intended to define in objective terms the response of the hard and soft tissues to ridge     augmentation.   "
57531|NCT02532530|"     Delirium is an acute brain syndrome characterized by a disturbance in consciousness     accompanied by periods of inattention and changes in cognition. Memory impairment, irrelevant     speech and disorientation are commonly observed signs and symptoms. Episodes of delirium have     been associated with a prolonged hospital stay, functional and cognitive dysfunction and even     an increased mortality. Delirium is a common complication in the postoperative setting where     the incidence increases with the risk of surgery. The estimated incidence of postoperative     delirium after cardiovascular surgery is remarkable, ranging from 31% up to 51%. Diverse     preoperative risk factors have been documented for patients undergoing cardiac surgery: age,     pre-existing cognitive dysfunction, a history of alcohol abuse and the severity of illness at     admission.      An early diagnosis of postoperative delirium is of great importance to prevent long-term     cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should     be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS)     provides information on brain oxygenation by quantifying the regional cerebral oxygen     saturation (SctO2) at the microvascular level. Recently, two studies showed that preoperative     cerebral tissue oxygenation was lower in the cohort of patients that developed delirium     postoperatively. Nevertheless, these studies did not investigate whether the onset of     postoperative delirium coincided with a change of postoperative SctO2. A relationship between     delirium and reduced cerebral blood flow has already been suggested. As such, the occurrence     of a postoperative decrease of SctO2 might have been overlooked thus far. Hence,     Investigators want to conduct a prospective, interventional study to determine the     relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.   "
57532|NCT02532504|"     The aim of this study is to deliver CBT based intervention called Change your life with 7     Sheets of paper to women with mild to moderate postnatal depression (PND) through trained     traditional birth attendants (TBAs). Participants will be recruited from low income area in     Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers     having children between birth till 12 months. Group intervention will be delivered through     trained TBAs.   "
57533|NCT02532491|"     This study compares the efficacy and effectiveness of two of the second-generation     antipsychotics (SGAs) most used in our society in the treatment of schizophrenia     (Aripiprazole and Risperidone) and the investigators do within an assistance program of     early-stage psychosis individuals of the Community of Cantabria, clinical reference for the     treatment of this disease in the Spanish Autonomous Community. Patients are included in a     prospective naturalistic study, open flexible-doses and randomized into one of two possible     patterns of treatment that includes the protocol.   "
57558|NCT02532153|"     Every 40 seconds, someone in the world dies by suicide. There is a lack of effective and safe     antisuicidal agents for preventing suicide attempts. This leads to the immense worldwide     individual, financial, and societal burden of suicide—which is projected to rise in the     coming decades—supporting the need for antisuicidal treatments.      This treatment gap may be filled through understanding the neurobiology of suicide, which can     guide the development of targeted antisuicidal treatments. Though some research has examined     the neurobiology of suicidal ideation in the context of depression—implicating the orbital     frontal cortex, anterior cingulate cortex, and striatum—the underlying pathophysiology and     neurobiology of suicidal ideation as a separate construct from depression remains largely     unknown. Therefore, the investigators propose to study the neurocircuitry of suicidal     thoughts, regardless of whether or not depression is present.   "
57534|NCT02532478|"     The risk factors for stoma reversal failure have been rarely studied, which is probably one     of the worst scenarios for a case who has a sphincter preserving procedure for a rectal     cancer and is expecting to have regular bowel movements through a functional anus. Several     studies have analyzed this particular issue and some have shown that up to 30% of 'temporary'     stomas have never been closed. However these data have been criticized to be heterogeneous,     since they have included patients with benign and malignant diseases, cases underwent     elective or emergent anterior or low anterior resections or restorative proctocolectomy; and     those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some     studies have underlined some risk factors for the failure of stoma reversal, but they also     have similar limitations as mentioned above. Finally, survival -to the best of investigators'     knowledge- has never been separately studied in patients who cannot receive a stoma reversal     procedure. Thus, current study aims to present a single-surgeon experience regarding the rate     of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in     patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to     expose the fortune of these cases.   "
57535|NCT02532465|"     Endotracheal intubation is the gold standard for securing the airway. However, while managing     patients with difficult airways, various supraglottic devices have been used as rescue airway     devices. The aim of this study is to compare the fiberoptic view through the internal aspect     of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view     through these two devices, the investigators will determine which device provides a clearer     passage to the glottic opening and is therefore the preferred conduit to aid endotracheal     intubation in difficult airways.   "
57536|NCT02532452|"     The purpose of this study is to demonstrate that viral specific T-cells (a type of white     blood cell) can be generated from an unrelated donor and given safely to patients with viral     infections.   "
57537|NCT02532439|"     Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some     factors of fracture occurrence have been highlighted. For example, some diseases or therapy     are known to increased risk of bone fracture only in some patients. Accordingly, it is     important for clinicians to identify patients at risk for bone fracture. Right now, various     tools are available for the clinicians:        -  clinical exam,        -  bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA),        -  an algorithm based on interrogation, clinical exam and bone mineral density. However,          prediction of bone fracture risk needs to be improved since only 50% of bone fractures          can be predicted. DEXA provides information for fracture risk estimation, but it is          unable to distinguish cortical part to trabecular part. It also fails to quantify the          microstructural properties that influence bone strength. Bone microarchitecture,          including the cortical compartment can now be assessed in vivo by the HR-pQCT. This          technique allows access to several parameters: on the one hand the volumetric bone          mineral density for the whole area measured as well as cortical and trabecular regions,          and on the other hand, the thickness and cortical porosity and the number of trabecular,          their orientation and distribution.      Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on cortical     and trabecular bone microarchitecture. This is the only noninvasive way to assess cortical     and trabecular bone microarchitecture.   "
57550|NCT02532270|"     The purpose of this study is to determine whether continuous non-invasive arterial pressure     (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the     outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive     arterial pressure (NIAP)measurement during spinal anaesthesia for cesarean section .   "
57538|NCT02532426|"     In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary     Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling     feature and also an independent determinant of survival. Muscular impairment involves loss of     muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative     capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to     elucidate the role of hypoxia in loss of muscle OXPHEN.      Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline     biopsies for association with the degree of hypoxemia. In addition, expression levels of the     key OXPHEN regulators will be measured in pre/post exercise biopsies.   "
57539|NCT02532413|"     The purpose of this study is to investigate antiviral efficacy of the combination treatment     with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for     chronic hepatitis B.   "
57540|NCT02532400|"     To compare the efficacy and safety of neoadjuvant aromatase inhibitor plus ovarian     suppression with chemotherapy in premenopausal patients with hormone receptor-positive breast     cancer.   "
57541|NCT02532387|"     Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT)     treatment.   "
57542|NCT02532374|"     The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD,     i.e., subjective effects) profiles, and the safety and tolerability of the     nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different     nicotine levels in smoking healthy subjects in relation to Nicorette® inhalator.   "
57543|NCT02532361|"     The objective of this study is to describe the proportion of hysterectomy in patients that     had undergone sterilization through hysteroscopic device placement and the patients that had     undergone sterilization through tubal ligation.   "
57544|NCT02532348|"     HIV infection is associated with an immune activation and an inflammatory response - despite     an active antiretroviral therapy - which may lead notably but not exclusively to     cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead     of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction.     Platelets may play a role in the occurrence of the inflammatory state: they contain big     amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of     platelets to the inflammatory state associated with HIV infection has been little studied.     Thus, it has been shown that platelets in HIV patients are able to release interleukin     (IL)-18. The group has shown with others that the platelet function could be altered during     HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with     platelets.      The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on     the platelets activation markers.   "
57545|NCT02532335|"     OCAPUSH (EudraCT 2014-002313-33) is a double-blind placebo-controlled parallel-arms study of     the effects of obeticholic acid on farnesoid X receptor expression in jejunum and on gut     microbiota in morbidly obese patients and healthy volunteers. Obeticholic acid (OCA,     6-ethyl-chenodeoxycholic acid, INT-747) is a semi-synthetic derivative of the major human     bile acid chenodeoxycholic acid and will be administered orally at a dose of 25 mg/day during     three weeks to 20 morbidly obese patients awaiting Roux-en-Y gastric bypass and to 20 healthy     volunteers. On the days before the first and after the last dose faeces and blood are sampled     for the analyses of bile acids and the gut microbiota. On the day after the last dose a     push-enteroscopy is performed in conscious sedation for biopsy taking in the jejunum.These     procedures are repeated 6 month after surgery in the morbid obese patients. Inclusion     criteria are male or female gender, 20-65 years of age and morbid obesity (BMI >35 kg/m2)     eligible for bariatric surgery. Exclusion criteria are liver diseases other that fatty liver     disease, other significant morbidity, medications known to interact with OCA, pregnancy,     uncertainty about safe and reliable contraception, and problems to understand or adhere to     the protocol. The primary objectives of this pharmacodynamic trial are the study of the     effect of OCA on the expression of FXR in the jejunum and small intestinal permeability, and     on fecal bile acids and gut microbiota. The secondary objectives are the study of the effects     of OCA on the genome-wide FXR DNA binding sites (cistromics) with the global gene expression     profile (transcriptomics) in human jejunum.   "
57546|NCT02532322|"     Uncontrolled pain after posterior fossa surgery and associated negative side effects of     conventional opioid therapy causes significant morbidity and mortality in infants and     children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to     moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children.     However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in     children undergoing posterior fossa surgery. In this prospective, randomized controlled     trial, the investigators aim to determine whether the addition of IV acetaminophen for 24     hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical     procedures of the posterior fossa compared with conventional therapy.   "
57547|NCT02532309|"     This is a 2-year, open-label, randomized study to evaluate the efficacy of Rosuvastatin     dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese patients     with Carotid Atherosclerosis.   "
57548|NCT02532296|"     Improving hospital-to-home care transitions can produce improvements in patient safety and     health care outcomes, while decreasing medical costs. Most transitions research has examined     strategies for older patients. This project, however, focuses on younger, high-risk patients     within a safety net system. The proposed intervention is based on research that patient     activation, as measured by the Patient Activation Measure (PAM), is correlated with risk for     hospital readmission. The intervention seeks to increase PAM scores by employing a Transition     Coach to coach patients, prior to and for 30-days after discharge, to (1) improve     self-management skills through goal setting and goal attainment; (2) to enhance patient     capacity to engage in trusting relationships with the Primary Care Provider (PCP), other     medical specialists, family members of friends, and the Transition Coach; and (3) to improve     ability to navigate the medical system.      The investigators will conduct a randomized trial to determine; (a) if PAM scores can be     increased in the 30-day after hospital discharge; (b) if increased PAM scores, in this     setting, are correlated with changes in healthcare utilization patterns; and (c) if the     intervention presents a viable strategy to change healthcare utilization patterns and reduce     rehospitalizations.   "
57552|NCT02532244|"     The goal of this study is to establish a genetic registry of patients with early-onset motor     neuron and neuromuscular diseases. The investigators will collect samples from patients with     a motor neuron or a neuromuscular disorder and their family members. The samples to be     collected will be obtained using either non-invasive (saliva and buccal swabs) or minimally     invasive (whole blood) means. The research team will then extract high quality genomic DNA     from these samples and use it to identify and confirm novel gene mutations and to identify     genes which regulate the severity of motor neuron/neuromuscular diseases.   "
57553|NCT02532231|"     The goal of this clinical research study is to learn if opdivo (nivolumab) can help to     control AML. The safety of nivolumab will also be studied.   "
57554|NCT02532218|"     The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to     placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with     dyslipidemia.   "
57555|NCT02532192|"     The goal of this clinical research study is to find the highest tolerable dose of belinostat     that can be combined with standard chemotherapy drugs (rituximab, cisplatin, cytarabine, and     dexamethasone) in patients with relapsed or refractory DLBCL who are eligible for an     autologous stem cell transplant (a transplant of the patient's own stem cells). The safety of     the study drug will also be studied.   "
57556|NCT02532179|"     This is an open label trial of mouse allergenic extract administered by subcutaneous     injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:        -  the safety of this therapy when given by injection        -  biomarkers of the immune response and        -  whether the therapy would be effective in treating allergic asthma.   "
57557|NCT02532166|"     The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%,     that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with     infection of the skin, the oral with his known premalignant potential in up to 2-3%     predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is     also an manifestation of the lining of the esophagus, which can then be associated with     symptomatic strictures of the esophagus.      The value of moreover increasingly established endoscopic imaging procedures are investigated     as well as data of the natural long-term outcome in esophageal lichen planus infestation     especially in view of malignant transformation.   "
57559|NCT02532140|"     • To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK     5107 alone and in combination with cefepime in healthy adult human subjects.   "
57853|NCT02528305|"     This pilot study aims to investigate whether 6 weeks of twice weekly High-intensity Interval     Training (HIT) results in improvements in disease-specific measures, feelings of general     well-being, physical fitness and cognitive function in patients with non-alcoholic fatty     liver disease or non-alcoholic steatohepatitis.   "
57560|NCT02532127|"     Cone Beam Computed Tomography (CBCT) is an emerging X-ray technology that has found wide     applications in dentomaxillofacial imaging. The ability to provide high-resolution 3D images     has resulted in a significant increase in the volume of dental radiology procedures. Although     CBCT is associated with higher radiation risk to the patient than conventional dental X-ray     imaging (intraoral or panoramic), it is considered to be 'low dose' imaging as defined by the     High Level Expert Group (HLEG) with doses ranging from a few microsieverts (μSv) to     millisieverts (mSv) per examination.      This proposal is set to tackle important issues raised by the HLEG and the Multidisciplinary     European Low Dose Initiative (MELODI) platform. In particular, as deduced by the name DIMITRA     (Dentomaxillofacial paediatric imaging: an investigation towards low dose radiation induced     risks), the project focuses on the uncertainties associated with radiation-induced health     risks at low doses in paediatric dentistry and is a multidisciplinary effort to approach the     involved risks from different yet interrelated perspectives: radiobiological     characterisation, dosimetric quantification, epidemiological surveying and image quality &     dose optimization. A unique Monte Carlo simulation (MC) framework will be used to accurately     calculate organ doses in dental CBCT imaging, to quantify the radiation induced risk and to     feed the radiobiology team with the appropriate data towards the identification, development     and validation of biomarkers for radiation induced health effects. Furthermore, it will     constitute the basis upon setting up a gender and age related epidemiology study. The balance     between image quality and dose levels will be explored aiming at reducing the risk through     image quality optimization.      It is expected that DIMITRA`s outcomes and deliverables can be presented to a wider forum via     a dissemination meeting, leading to further recommendations and potential future adaptations     for the use of CBCT in paediatric dentistry.   "
57561|NCT02532114|"     This phase I trial studies the side effects and best dose of niclosamide when given together     with enzalutamide in treating patients with castration resistant prostate cancer that has     spread from the primary site to other places in the body. Androgens such as testosterone can     cause the growth of prostate cancer cells. Drugs like enzalutamide block androgens from     driving tumor growth; however, when androgen receptor splice variants are present, these     drugs may not be effective. Niclosamide may decrease the amount of androgen receptor splice     variant present within tumor cells, thus promoting the anti-tumor effects of enzalutamide.     Giving niclosamide together with enzalutamide may be a better treatment for prostate cancer.   "
57562|NCT02532101|"     Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in     this spontaneous diabetes model. The present study aims to determine the beneficial effects     of Oil Palm Phenolics in uncontrolled insulin treated type 2 diabetic patients.   "
57563|NCT02532088|"     Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in     this spontaneous diabetes model. The present study aims to determine the beneficial effects     of Oil Palm Phenolics in subjects with pre-diabetes.   "
57564|NCT02532075|"     The purpose of this study is to investigate the effects of performing a breathing muscle warm     up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The     main aim is to see whether performing a breathing muscle warm up can improve distance walked     in a 6 minute walk test and also decrease perceptions of effort and breathlessness.   "
58710|NCT02517086|"     The objective of this study is to evaluate the effect of elastic compression, functional     compressive bandaging (ECF) and active exercises in the bloodstream of the upper member     ipsilateral to the surgical procedure for the treatment of breast cancer.   "
57565|NCT02532062|"     This study aims to establish the ability of 4,000 IU oral vitamin D3 per day (in combination     with a daily multivitamin) to safely convert vitamin D3-deficient subjects at increased risk     of lung cancer to a vitamin D3-sufficient state, and to explore effects of vitamin D3     supplementation in this population on markers of inflammation and lung cancer risk. Current     and former smokers with chronic obstructive pulmonary disease (COPD) are at increased risk of     developing lung cancer and represent the clinical population of interest for this study.   "
57566|NCT02532049|"     This is a clinical trial in which healthy volunteers will be administered one or two     experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA     Pfs25-IMX313 in a prime-boost regime.      All vaccines will be administered intramuscularly.      Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.      Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.      Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA     Pfs25-IMX313 at 1x10^8 pfu eight weeks later.      Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA     Pfs25-IMX313 at 2x10^8 pfu eight weeks later.      The study will assess the safety of the vaccinations, and the immune responses to the     vaccination. Immune responses are measured by tests on blood samples.      Healthy volunteers will be recruited in Oxford and Southampton, England.   "
57567|NCT02532036|"     TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis     (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route     in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.   "
57568|NCT02532023|"     The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their     combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β,     IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of     COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.   "
57569|NCT02532010|"     The purpose of this study is to see if a medicine called pacritinib is both safe and     effective as a study intervention for patients with AML in combination with either decitabine     or cytarabine. Pacritinib is an experimental drug that is being studied to treat acute     myeloid leukemia (AML). Decitabine and cytarabine are both FDA approved drugs that are used     in treatment of AML. Pacritinib is being tested in clinical trials and has not been submitted     to the U.S. Food and Drug Administration (FDA) for approval for any indications. Pacritinib     is a drug that is designed to slow down the growth of leukemic cells.   "
57570|NCT02531997|"     The purpose of this study is to determine if hypnotic relaxation therapy is a more effective     intervention for improving self-image in women who have been diagnosed with breast or     gynecologic cancer when compared to progressive muscle relaxation therapy.   "
57571|NCT02531984|"     Bronchiectasis is characterized by a permanent and abnormal dilatation of a part of the     bronchial tree. An accumulation of mucus in the respiratory tract ensues, resulting in     frequent bacterial infections and eventual destruction of the lungs. Clinically, patients     present with a chronic productive cough and episodes of acute respiratory exacerbations.     Chronic respiratory failure can follow. Although its prevalence is largely unknown,     bronchiectasis is considered to be a rare and orphan disease. There are numerous causes for     this disease: sequelae of respiratory infections, immunodeficiency, genetic diseases like     cystic fibrosis, primary ciliary dyskinesia….The focus of this study will be on non cystic     fibrosis bronchiectasis in children.      Due to a lack of pediatric clinical trials, the management of children with this disease is     widely based on the management of adults or patients with cystic fibrosis or     pan-bronchiolitis. The treatment is based on respiratory physiotherapy, prevention of     infections, administration of inhaled corticosteroids and anti biotherapy for acute     exacerbations.      Recently, some studies have demonstrated the efficacy of a family of antibiotics, the     macrolides, in the treatment of cystic fibrosis or pan-bronchiolitis in children. Indeed,     taken 3 times a week during a long period of time, the macrolides, and specifically the     azithromycin have shown some anti-inflammatory and tissue repairing properties, in addition     to their antimicrobial properties.      Moreover, several studies conducted in the adult population have shown that the use of     azithromycin has led to significant reduction in the frequency of respiratory exacerbations     as well as an improvement in the quality of life.      The efficacy of azithromycin in these respiratory diseases has led to enlarge its use for the     long term treatment of bronchiectasis. Yet, this type of treatment has no marketing     authorization application.      No studies have been conducted in children, but individual examination of patients with     bronchiectasis treated with azithromycin suggests an improvement of their symptoms.      Thus, the use of azithromycin in the treatment of bronchiectasis in children seems to be a     promising therapy. However, its efficacy needs to be demonstrated by clinical trials led on a     pediatric population with an adequate number of patients and a strong methodology in order to     ensure validity and reliability of the results.      Therefore the investigators decided to conduct a comparative, prospective multicenter     randomized study in this population.      This study intends to include 100 patients already treated by azithromycin for at least 6     months. After inclusion, they will be randomized in two groups of 50 patients each. The first     group will continue the treatment and the other one will discontinue it.      The patients will be followed from the inclusion period (M0) until the onset of the first     exacerbation for a maximum of 6 months (M6), with an intermediate health care visit after 3     months (M3).      In case of exacerbation, a health care visit will be scheduled; the patient will receive the     appropriate treatment and he will be suspended from the study.      The duration of follow up for each patient is dictated by the occurrence of the first     respiratory exacerbation, a maximum of 6 months .The total inclusion period is 12 months and     the total duration of the study is 18 months.   "
57572|NCT02531971|"     The study to be performed will utilize already FDA-approved marketed products in healthy     adults for the purpose to generate data for establishing rate of drug delivery comparisons     between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and     Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these     types of products.   "
58795|NCT02515968|"     The purpose of this study is to investigate whether propofol can improve quality of recovery     compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy.   "
57573|NCT02531958|"     Recently, the United States Department of Agriculture (USDA) has recommended removal of the     300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a     connection between cholesterol intake and increased risk for cardiovascular disease (CVD).     Previous work has shown that daily intake of eggs actually favorably alters many parameters     associated with CVD risk. Conversely, emerging research suggests that choline, a nutrient in     eggs, may be converted into trimethylamine oxide (TMAO) by the intestinal microbiota. TMAO is     thought to increase the risk for CVD. Therefore, the purpose of this study is to determine a     threshold of daily egg intake at which the risk for CVD is not negatively impacted in a     young, healthy population.   "
57574|NCT02531945|"     The main objective of the study is to investigate the correlation between the measurement of     the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface     topography.      The device used in this research to the topography examination is three-dimensional     morphometry device of AXS Medical society : the BIOMOD L.   "
57575|NCT02531932|"     The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared     to the combination of carboplatin and everolimus for the treatment of advanced     triple-negative breast cancer (TNBC).   "
57576|NCT02531919|"     This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in     patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may     inhibit the spread of the tumor to other parts of the body (metastases) and improve survival.   "
57577|NCT02531906|"     This randomized pilot clinical trial studies the side effects of gabapentin and how well it     works when given together with methadone hydrochloride and oxycodone hydrochloride in     improving quality of life in patients with stage II-IV head and neck cancer during     chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help     relieve moderate or severe pain caused by head and neck cancer during and after     chemoradiation therapy.   "
57588|NCT02531763|"     BE FIT (Behavioral Economics Framingham Incentive Trial) is a pilot study to test the     deployment of a social incentive intervention using the Framingham Heart Study (FHS)     Offspring, Generation 3, and Omni cohorts to increase physical activity (PA). The     investigators will leverage the strength of FHS by recruiting trios and nuclear families to     test whether social connectedness increases PA. The investigators will utilize a randomized     controlled trial design. The investigators will test a social incentive intervention strategy     using a team-based design in which participants work together to jointly achieve their PA     goals, and a social connectedness intervention.   "
57635|NCT02531139|"     Anesthesia reduces blood pressure and cerebral blood flow is normally considered to be     maintained despite marked changes in blood pressure. Vascular surgical patients are often     elderly, have high blood pressure and atherosclerosis and in these patients cerebral blood     flow may decrease if blood pressure is reduced during anesthesia. The purpose of this study     is to assess the effect of blood pressure for preservation of cerebral blood flow during     anesthesia in vascular surgery. The hypothesis is that in vascular surgical patients, during     anesthesia, cerebral blood flow is higher with blood pressure maintained at a higher level     than that used in normal clinical practice.   "
57578|NCT02531893|"     Background:      When children have severe irritability and temper outbursts, they can be so cranky or angry     that it leads to problems at home, in school, and with friends. This is called Disruptive     Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed     specifically for children with this problem. Researchers think two forms of therapy,     Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help     children with DMDD.      Objective:      To test two whether IBT and CBT can decrease severe irritability in children and youth.      Eligibility:      Children 8-17 years old with DMDD. Their symptoms must have started before age 10.      Design:      Participants will be screened with a review of their symptoms. Parents and participants will     answer questions.      Participants can do only one or both of these treatments if they wish. Those who wish to do     both will start with IBT.      Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent     will participate in part of the sessions.      Participants will talk about what makes them irritable and how it affects them. They may be     put in situations that might make them annoyed or irritable.      Participants will rate how intense their irritability is. Parents and participants will     complete rating scales, questionnaires, and interviews.      Participants will do practice activities at home.      Participants doing IBT will have up to 14 sessions over 10 weeks.      Participants will view 15 faces, one at a time, on a computer. They will choose if the face     looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will     complete some sessions at the NIH and some at home.      Participants and parents answer questions about their progress.   "
57579|NCT02531880|"     Background:      - The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a     neurological disease that causes seizures. It can affect this barrier. Researchers think a     contrast agent called mangafodipir might be better able to show areas of the brain that     epilepsy affects.      Objective:      - To see if mangafodipir is well tolerated and safe. To see if it can show, on an MRI, areas     of the brain that epilepsy affects.      Eligibility:        -  People ages 18-60 who:        -  Have epilepsy not controlled by drugs        -  Are enrolled in protocol 01-N-0139        -  Healthy volunteers      Design:        -  Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Participants will have up to 6 visits in 1 3 months. Those with epilepsy will have an          inpatient stay lasting 2 10 days. Visits may include:        -  Video-EEG monitoring for participants with epilepsy (not for healthy volunteers)        -  An IV catheter put in place: a needle guides a thin plastic tube into an arm vein.        -  Getting mangafodipir through the IV.        -  5 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the          brain. Participants lie on a table that slides into a metal cylinder. They are in the          cylinder for 45 90 minutes, lying still for up to 10 minutes at a time. The scanner          makes loud knocking sounds. Participants will get earplugs.        -  A final MRI at least 2 weeks after receiving mangafodipir. Gadolinium is given through          an IV catheter.   "
57580|NCT02531867|"     This is a multicenter study in Japan. Eleven sites which have already participated in the     investigator-initiated clinical study (Early Access Program) will participate in this     study.The objective of this study is to gain further information on the safety and efficacy     of treatment with asfotase alfa.   "
57581|NCT02531854|"     -  Open label        -  Enrollment in the order of confirmation of eligibility and HPV+ tumor status        -  Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR)          mutation status, performance status and first-line induction chemotherapy outcome;        -  Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus          ADXS11-001 vs. 42 patients receiving pemetrexed alone)        -  Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy        -  Control Arm: Pemetrexed only        -  Positive control: pemetrexed chemotherapy   "
57582|NCT02531841|"     In the presently planned multicentre Phase III trial the two therapies will be compared:     Patients will be randomized after intensified induction treatment with 4 cycles rituximab,     methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy     against conventional consolidating therapy with 2 cycles of conventional chemotherapy with     R-DeVIC (rituximab, dexamethasone, etoposide, ifosfamide, carboplatin).   "
57583|NCT02531828|"     The aim of this study is validate the use of biopolymer from sugar cane molasses film     (POLYSHAFT®) a product developed in Experimental Station research laboratories (UFRPE)     comparing to polyurethane film, or similar, used as a bandage after surgical correction of     hypospadias, as well as other procedures. The main objective of the study is to prove the     hypothesis the POLYSHAFT® presents similar or better outcomes in terms of biocompatibility,     when compared to the polyurethane film when used as a bandage.   "
57584|NCT02531815|"     This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind,     placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and     pharmacodynamics of PF-06741086.   "
57585|NCT02531802|"     The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT     adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.   "
57586|NCT02531789|"     Current post-operative monitoring of patient recovery consists measuring two blood markers     C-reactive protein (CRP) and White Blood Cell Count (WBC). However, these are slow to respond     to the onset of infection. However, monitoring the absolute levels of the proteins in the     three pathways of the complement cascade should provide a faster and better predictor of     patient recovery. The investigators propose a pilot trial to measure concentrations of     Complement Cascade (CC) activation biomarkers in the blood over a time course around     operations of major abdomino-pelvic surgery involving a bowel resection. Further, analysis of     the differential CC pathway activation should identify the onset of recovery complications     before clinical symptoms present and potentially identify the causes allowing the clinicians     to target therapies.   "
57587|NCT02531776|"     This study will focus on how different injection needles are perceived by patients. The     needles differ in design and mechanical properties, and will be tested in people with Type 2     Diabetes. The measured parameters during and after needle insertion are: penetration force     through skin (measured with force gauge), pain perception (rated on visual analog scale, VAS,     on a scale from 0 to 10), and skin blood perfusion at insertion site (measured with laser     speckle contrast scanner). Furthermore, any skin reactions will be recorded.   "
57589|NCT02531750|"     Introduction This study will evaluate the effect on glucose, lipid and bone metabolism     following conservative orthopaedic procedures in patients who suffered from acute Achilles     tendon rupture. The sedentary rehabilitation period following these procedures may impact     negatively upon glucose, lipid and bone metabolic pathways whereas the more physically active     rehabilitation period instituted 8 weeks after the injury is hypothesized to impose positive     metabolic effects.      The study is addition to the on-going clinical trial, Non-operative Treatment of Acute     Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization,     ClinicalTrials.gov Identifier: NCT02015364.      Perspective This study will establish whether the well-known effects on glucose, lipid and     bone metabolism of a sedentary lifestyle can be observed already following 8 weeks of almost     total abstain from physical activity in non-diabetic individuals, who suffered an acute     Achilles tendon rupture. Thereby, we will add knowledge to the previous findings following     strict bed-rest in healthy individuals on glucose and lipid metabolism and bone turnover. In     a clinical perspective it is important to examine the extent to which individuals deteriorate     in various metabolic pathways to better understand the pathophysiology behind these defects     both in healthy individuals and in patients, who undergo bed rest or an equal reduction in     physical activity as part of their rehabilitation.      Study design The present study includes 50 cases, who are examined early following injury (<     2 weeks) (baseline), 8 weeks (6 - 10 weeks) after injury and 52 weeks (40 - 64 weeks) after     injury, respectively.      Oral glucose tolerance test (OGTT) with ingestion of 75 g of glucose during a maximum of 3     min from baseline (0 min). Plasma for glucose, insulin, C-peptide, NEFA will be drawn.      The individual will bring in morning spot urine for measurement of suPAR, creatinine, albumin     and orosomucoid.      The individual will have drawn blood for measurement of HbA1c, total cholesterol, LDL     cholesterol, HDL cholesterol, triglyceride, Na, K, creatinine, HgB, CRP, leukocytes, ALAT,     alkaline phosphatase, Ca++, D vitamin, TSH, albumine and amylase. Also blood for BTM and     plasma suPAR, IL6, TNFa and hsCRP will be drawn. Finally blood for lipid density profiling     and lipid particle size will be drawn DXA of hip and lumbar spine including abdominal     visceral and subcutaneous fat is done on a Hologic Discovery scanner.   "
57590|NCT02531737|"     The purpose of this study is to determine whether nintedanib (vargatef®) combined with     docetaxel are effective in second line of treatment in patients with no squamous non small     cell lung cancer refractory to first line chemotherapy.   "
57591|NCT02531724|"     Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal     oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to     improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy     controls after cardiac surgery.      In order to investigate the effect of levosimendan in patients with AKI after cardiac     surgery, the investigators plan a randomized placebo controlled trial. 30 patients will     receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured     using infusion clearance technique of para-aminohippuric acid and Chromium     ethylenediaminetetraacetic acid (Cr-EDTA) respectively.   "
57592|NCT02531711|"     The goal of this proposed research is to assess the preliminary efficacy of dietary     interventions that change dietary fats in improving clinical outcomes related to lumbar     radicular pain. After a two-week baseline, consented participants are randomized to one of     two diets. Key foods consistent with the diet are provided for 12 weeks along with extensive     dietary counseling and support from the study-provided materials. Participants are encouraged     to follow the assigned diet for another 6 weeks without provision of food.      Participants complete questionnaires at baseline, randomization, and after 6 weeks, 12 weeks,     and 18 weeks on the diet. They provide blood samples at randomization (2 weeks) and after 12     and 18 weeks on the diet.   "
57593|NCT02531698|"     This study is looking at a new vaccine that might prevent meningococcal disease, and will     study the immune response elicited by this vaccine when given to healthy young children. The     study will also look at the safety of the new vaccine as well as how it is tolerated.   "
57594|NCT02531685|"     Many infectious pathogens, like ETEC, initiate infection by first interacting with the gut     mucosal surfaces of their human host. Consequently, vaccination strategies that can better     stimulate protective mucosal immunity are needed if we are to effectively control the large     number of intestinal pathogens that cause morbidity and mortality in humans. The LT toxin of     ETEC is a unique antigen in that it also has inherent mucosal adjuvant properties for     co-administered antigens. Thus, this protein has the potential to be both a stand-alone     vaccine as well as a mucosal adjuvant for other co-administered vaccine antigens. The primary     objective is to assess the safety and tolerability of dmLT vaccine when administered in three     doses intradermally over a range of dosages in healthy adult subjects.   "
57595|NCT02531672|"     The purpose of this study is to use a new imaging drug called 11C-choline that is used with a     PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as bone     scans, CT or MRI.   "
57596|NCT02531646|"     The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital     Tomosynthesis (DE-DT) application against the commercially available predicate devices.   "
57597|NCT02531633|"     Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high     affinity and specificity for binding to the human IL-6 molecule that may have therapeutic     benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic     pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3     (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This     study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk     profile of sirukumab in the treatment of active GCA. The study will be conducted in 2     distinct parts (Part A and Part B) and consists of the following phases: Screening phase,     Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the     option to receive open-label sirukumab based on disease status and a 16-week follow-up phase     if applicable.      Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of     baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive     one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone     taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week     52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week     extension phase, designed to investigate the long-term maintenance of remission and safety     following cessation of sirukumab treatment and to assess long-term corticosteroid use.     Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the     first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need     to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of     study drug, applicable only for those who are withdrawn prematurely from the study or whose     open-label sirukumab treatment in Part B completes after Week 88.   "
57598|NCT02531620|"     This is a pilot study designed to evaluate a programme of rehabilitation for patients     undergoing elective colorectal resection surgery.   "
57599|NCT02531607|"     This is a non-randomized natural history protocol in which patients undergoing surgery or     endoscopy for suspected/ diagnosed pancreaticobiliary strictures are assigned to a) control     (chronic pancreatitis, no pancreatic neoplasm, primary sclerosing cholangitis), b)     non-carcinoma (bile duct stones, papillary stenosis, ), c) carcinoma non-pancreatic     (ampullary and distal bile duct or cholangiocarcinoma) and d) pancreatic ductal     adenocarcinoma (pancreatic cancer.   "
57619|NCT02531347|"     The purpose of the study is to compare antihypertensive treatment based on either     conventional blood pressure measurements or telemedical home blood pressure measurements.      Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood     pressure, is more cost-effective and provides better quality of life.   "
57600|NCT02531594|"     This study will test the efficacy of a cessation intervention for caregivers in a large,     inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers     who smoke who present to our Pediatric Emergency Department with their child who has a Second     Hand Smoke exposure-related illness to either one of two conditions: 1) Screening, Brief     Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control (HHC).     The Screening, Brief Intervention, and Assisted Referral to Treatment condition will include     a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence,     motivational interviewing, engaging and personalized materials on the effects of smoking and     Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources     (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement     therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program will be     used as an attention control in which caregivers will receive instruction on healthy     lifestyle choices to improve the child's health.   "
57601|NCT02531581|"     Pulmonary embolism (PE) is a serious disease with frequent intra hospital mortality remains     high. If anticoagulation is perfectly codified, the remainder of the initial management has     been less studied.      In particular, the conditioning Initial often involves systematic plasma volume of 250 to     500 cc, by analogy to other situations. But this treatment option is not based on factual     data. In the right ventricular dysfunction that often accompany severe EP, volume expansion     may instead be harmful, according to the law of Frank Starling. A retrospective study has     recently shown a benefit of diuretic therapy in patients hospitalized for severe normotensive     EP.      The proposed study is interventional, prospective, multicenter, randomized, require to     include 60 patients.      The main objective of the study is the comparison of the troponin normalization period Ic     (biomarker of right ventricular dysfunction) in patients hospitalized in the initial phase of     a serious normotensive EP, between the 2 groups diuretic and filling Vascular.      The primary endpoint is the time in hours standardization of troponin Ic.      The secondary endpoints will be:        -  the period of normalization of Brain Natriuretic Peptide (BNP)        -  changes in echocardiographic parameters of right ventricular dysfunction        -  a composite endpoint: cardiovascular death / cardiogenic shock / use of amines / use of          thrombolysis.   "
57602|NCT02531568|"     The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin   "
57603|NCT02531555|"     Background: Aim of this randomized controlled parallel-designed study was to evaluate the     effects of diode laser as an adjunct to mechanical periodontal treatment on clinical     parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed     following initial periodontal treatment in chronic periodontitis (CP) patients.      Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were     included and randomly assigned into 3 groups. Residual pockets were treated either only by     mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or     by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI),     bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival     recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF     samples were collected at baseline, 1 and 8 weeks after treatment.   "
57604|NCT02531542|"     Elderly people constitute the largest proportion of emergency room patients, representing 12%     of all emergency room admissions. The need for diagnostic tests or therapeutic interventions     is much greater in this patient population. Cardiovascular diseases and symptoms represent     12% of the causes for emergency room admission, and patients suffering from cardiovascular     disease are those whose emergency room visit lasts longest.      The diagnostic approach in the emergency room in elderly patients admitted for acute dypsnoea     is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it     has an impact on prognosis. The clinical signs are difficult to interpret, and are     non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some     authors have reported up to 50% of diagnostic errors in elderly patients.      Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis.     However, peptides suffer from several limitations, particularly in situations that are often     encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome,     pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass     index. Diagnostic performance deteriorates with increasing age, and there is a significant     increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly     patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left     heart failure.      Some authors have suggested using lung ultrasound in the initial work-up of acute respiratory     failure, since some specific profiles are known to be related to the presence of interstitial     oedema, reflecting impaired left heart function (e.g. presence of B lines). These studies     were performed in the context of intensive or critical care, but data are sparse regarding     the application of this approach in the emergency room.      The hypothesis is that the diagnostic accuracy of a targeted and quick echographic approach,     namely the READ method (Rapid Echography for Acute Dyspnoea), comprising targeted lung     ultrasound combined with isolated measure of transmitral flow, would be superior to that of     NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to     the emergency department.   "
57605|NCT02531529|"     To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion     during donor hepatectomy.   "
57606|NCT02531516|"     The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone     (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer     receiving primary radiation therapy results in an improvement of metastasis-free survival.   "
57607|NCT02531503|"     The purpose of this study is to determine the predicting factors for asthma remission in     children.   "
57608|NCT02531490|"     Paradoxical fetal and maternal results of studies have led to inconsistent use of     antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in     the Netherlands. However, none of the studies have taken the individual maternal circulatory     state or the contemplated blood pressure response into account. Hypertension may be     accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low     (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to     one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors     of the hemodynamic state rather than solely reducers of blood pressure. Without taking the     maternal hemodynamic profile and condition into account, generic antihypertensive treatment     can be expected to result in disappointing, inadequate and paradoxical results. The     investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically     guided antihypertensive therapy (with target systolic and diastolic blood pressure     <130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to     no treatment, without the alleged side-effects.   "
57609|NCT02531477|"     Intra-Carotid delivery of propofol.   "
57620|NCT02531334|"     This study is being conducted to evaluate the efficacy of TA-65, a purified extract of     Astragalus root, on insulin resistance, oxidative stress, and inflammation in individuals     classified with metabolic syndrome.   "
57610|NCT02531464|"     Family caregivers play a crucial role in cancer patients care, as they are their principal     source of support. It is well recommended to provide them with the resources, information and     support needed to maintain a good health, and to sustain their caregiving role. Recently,     oncology centres have implemented systematic distress screening programs, but the focus has     been limited to cancer patients, with little intervention on family caregivers. This study     aims to address this gap. It will implement and test the effectiveness of a simple     intervention integrating primary care and oncology care that transfers into practice the main     recommendations of governmental authorities and experts to globally improve supportive care.     The intervention includes systematic distress screening and problems assessment of family     caregivers at diagnosis, and every two months, privileged contact with a nurse away from the     patient to address caregivers distress and identified problems, and for caregivers     experiencing high level of distress, liaison by the study nurse with their family physician     to transfer information on their identified problems and level of distress and to facilitate     shared follow-up. This intervention has been pilot-tested with family caregivers, health care     providers and decision makers involved in lung cancer care, as well as with community-based     family physicians, to ensure its feasibility and acceptability. This study findings may     clearly improve patient and caregiver experience of cancer care, and reduce the burden of     disease.   "
57611|NCT02531451|"     In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg     ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During     these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions).     Before and after training, muscle volume is measured by MRI, and muscle strength is assessed     by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus     lateralis to study gene and protein expression of markers regulating muscle protein turnover     and prostaglandin synthesis.   "
57612|NCT02531438|"     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared     to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.   "
57613|NCT02531425|"     Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to     approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or     subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of     local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into     accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single     28-day cycle.   "
57624|NCT02531282|"     The study's primary objective is to test the hypothesis that a group-based health promotion     intervention with patient education and practical exercises delivered at a Healthy Life     Centre increases patient activation in people living with chronic pain. Due to many people     living with chronic pain, interventions focusing on self-management and coping are on the     agenda in primary care. This study will investigate whether a Healthy Life Centre in a     municipality is a suitable setting for interventions targeting people living with chronic     pain. Short and long term effect of an intervention developed in a health promotion and     salutogenic framework will be investigated in a randomized clinical trial.   "
57614|NCT02531412|"     Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury     is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow     restoration and accompanying reperfusion injury (ischemia-reperfusion injury. Several     studies, mainly in animal models have tried to establish spironolactone role on kidney injury     induced by ischemia-reperfusion injury. It has been demonstrated in renal transplant     recipients that the administration of spironolactone can prevent oxidative stress and is     safe. The group of cancer patients with states capable of producing tissue hypoperfusion     (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk     of developing acute renal ischemia-reperfusion injury.      The investigators hypothesis is that spironolactone may be useful in preventing acute renal     injury when administered during the first six hour of renal ischemia-reperfusion insult.      The purpose of this study is to determine the utility of spironolactone administered after an     ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer     patients.      Investigators propose a pilot study, randomized, double blind, placebo controlled trial,     approved by the local ethical committee, to compare the efficacy of spironolactone to prevent     acute kidney injury in patients after major surgery. Investigators will include 12 patients     in spironolactone group (25mg daily for three days) and 12 patients in placebo group.   "
57615|NCT02531399|"     Neurovascular coupling or functional hyperemia is defined as an essential physiologic     mechanism in the brain, which is necessary for the local adaption of blood flow to altered     metabolic demands of the tissue. It has been shown that also in the eye, blood flow is     considerably coupled to retinal neural activity. The current concept of functional hyperemia     is that visual stimulation, as flicker light, effectuates increasing neural activity in the     retina, which elevates the metabolic needs of the retinal tissue for oxygen and glucose and     consequently induces dilatation and augmented blood flow in the retinal vasculature. In     several studies, stimulation with flicker light has been shown to induce an increase of blood     flow in major retinal arteries and veins as well as an increase of optic nerve head blood     flow. Up until now, flicker induced changes in blood flow were measured solely in the major     retinal arteries and veins with systems such as the commercially available dynamic vessel     analyzer (DVA) by Imedos and with laser Doppler velocimetry (LDV).      In the present study, the investigators propose to measure the response of total retinal     blood flow to diffuse luminance flicker stimulation with bi-directional Fourier Domain     Doppler Optical Coherence Tomography (FDOCT) as well as with Laser Speckle Flowgraphy (LSFG)     in healthy subjects by assessing vessel diameter, blood velocity and blood flow of all     retinal vessels. For comparative reasons, the investigators will furthermore assess the blood     flow of major retinal arteries and veins with the dynamic vessel analyzer (DVA) and laser     Doppler velocimetry (LDV).   "
57616|NCT02531386|"     The objective of this study is the evaluation of system accuracy following ISO 15197:2013     (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood     glucose monitoring systems intended for self-monitoring of blood glucose by patients are     stipulated. In this study, system accuracy evaluation will be performed with CE-marked BGMS     (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva     Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care),     OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and     Accu-Chek Mobile with three different reagent system lots for each BGMS.      The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.   "
57617|NCT02531373|"     This study is designed to assess the effect of different dose levels of pneumococcal     polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and     infants.   "
57618|NCT02531360|"     The overall goal of this imaging trial is to characterize [18F]MNI-815, a PET radioligand for     imaging Tau.   "
57621|NCT02531321|"     The project is a two-arm prospective cohort and pharmacokinetic study comparing     levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking     antiretroviral regimens that include ritonavir to those in women who take regimens known not     to interact with combined oral contraceptives. In addition, the prevalence of ovulation will     be measured in each group. Participants will take a combined oral contraceptive containing     levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly     serum progesterones. On the final day, they will complete a pharmacokinetic study. The     investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve     from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels     will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be     unchanged.      This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of     a combined oral contraceptive containing the progestin levonorgestrel. In addition, no     previous studies have rigorously assessed ovulation in women taking protease inhibitors and     combined oral contraceptives. As a result, this study will provide new information     correlating pharmacokinetic changes with effects on ovulation.   "
57622|NCT02531308|"     Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects     with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)   "
57623|NCT02531295|"     The purpose of this study is to determine the safety and bioactivity of an herbal supplement     called kansui, which contains several active ingredients such as ingenols that may have a     role in helping clear HIV from the body. Kansui has been used in traditional Chinese medicine     for centuries to treat various ailments such as for eliminating excess fluid in the abdomen     or lungs, loosening phlegm from the chest, and relieving constipation. Based on preliminary     in vitro data from our group, kansui extract powder is a potent activator of HIV     transpcription in latently infected Jurkat cells. The investigators' hypothesis is that     kansui extract powder prepared as tea will be safe and well-tolerated, elicit an in vivo     immunologic response, and at the doses administered, increase HIV transcription in     latently-infected cells among HIV-infected patients on suppressive antiretroviral therapy.   "
57643|NCT02531035|"     This Phase 3 study is designed to demonstrate the net benefit of sotagliflozin versus placebo     in patients with T1D.   "
57644|NCT02531022|"     This study will use a randomized, controlled trial to test the effectiveness of a home-based     physical activity program using wearable devices and financial incentives. All participants     in will establish a baseline step count during the first two weeks and then proceed to a     16-week intervention period and 8-week follow-up period.   "
57625|NCT02531269|"     Using European data from patients included in the Named Patient Program (NPP) and from the     early post-marketing authorization period, the present study aims to describe patient     characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in     Europe. This will be a retrospective cohort study of patients who received treatment with a     DCV-based regimen in the following context:        -  Patients enrolled within the European NPP in one of the following countries Austria,          Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or        -  In those countries where DCV is commercially available (ie, Sweden, Germany, United          Kingdom), patients who received DCV during the early post-marketing authorization period      The results of this study will contribute to a better understanding of effectiveness of     DCV-based regimens in a population that differs from population in the clinical trials, and     therefore will provide additional valuable information to inform clinical practice.      This study intends to estimate primarily the effectiveness of DCV-based regimens as measured     by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As     well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end     of Hepatitis C virus (HCV).      This study intends also to describe as secondary objectives the characteristics (ie,     demographic and clinical characteristics and treatment patterns of patients starting a new     DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based     regimens as measured by:        -  On-treatment virological response at post treatment follow-up visit Week 4; and        -  Virological response at the end of treatment (EOT); and        -  The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post          treatment follow-up visit Week 24 (SVR24); and        -  The occurrence of virological failure (on-treatment and relapse).      An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the     overall population treated with DCV.   "
57626|NCT02531256|"     Evaluation of LMA Protector   "
57627|NCT02531243|"     The purpose of this study is to learn whether a new family therapy using computer games with     biofeedback might help people at clinical high risk for psychosis and their family members     learn to experience less stress and have fewer mental health challenges.   "
57628|NCT02531230|"     The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent     system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis     post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA)     and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2     & P3)   "
57629|NCT02531217|"     The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the     treatment of adult patients with molecularly defined genetic muscular dystrophies.   "
57630|NCT02531204|"     The purpose of this study is to assess the bioequivalence between ASP1585 granules and     ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules     under open-label conditions in non-elderly healthy male subjects. In addition, the safety of     these products is assessed.   "
57631|NCT02531191|"     The objective of this study is to evaluate the bioequivalence of a new tablet versus a     current tablet of ASP015K under fasting conditions after single oral administration in     healthy male subjects.   "
57632|NCT02531178|"     This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study designed     to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose     levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be administered once     every other week (EOW) for a total of 4 doses. Subjects will continue on their stable dose of     methotrexate weekly throughout participation in the study.      This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects     per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2     subjects will receive placebo. Subjects participating in one dose group will be ineligible to     participate in another dose group in the study.   "
57633|NCT02531165|"     Prospective, randomized, open-label, single-center, investigator-initiated trial, including     patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary     percutaneous coronary intervention (PPCI) within 12 hours of the symptom's onset. The study     aims to compare platelet inhibition (pharmacodynamics and pharmacokinetics) of pre-hospital     Ticagrelor in patients with STEMI according to two different analgesia protocols using     Fentanyl or Morphine.   "
57639|NCT02531087|"     Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily.     Individuals with osteogenesis imperfecta break bones often and may have other problems,     including hearing loss, dental problems, pain and difficulty getting around. Before the     genetic cause of OI was known, OI was classified into four types. Each type was based upon     the symptoms and severity of OI. In most people with OI, the cause is a change in one of the     genes that makes a protein called type 1 collagen. Some doctors now classify OI both on how     severe it is as well as which gene is causing OI. When people classify OI this way, there are     more than 10 types of OI. The current laboratory testing to determine OI subtype involves the     collection of blood and/or skin cells.   "
57640|NCT02531074|"     This pilot study evaluates the use of a mobile application to improve weight loss in obese     stroke patients. The investigators hypothesize that acute stroke patients who use the mobile     application are more likely to achieve a minimum 5% weight reduction during the critical six     months post-stroke, yielding considerable improvement in stroke risk factors.   "
57641|NCT02531061|"     Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid     arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some     criteria were already proposed and the last one was proposed in 2011.      All these criteria integrated only clinical criteria without imaging assessment. In this     context, ultrasound joint is daily performed without definition of remission. A discrepancy     exists between clinical remission and persistence of active disease with ultrasound joint     presence of a Doppler effect indicating inflammation and the risk of progression of joint     damage. A definition of remission in RA could include erosions regression in subchondral bone     (at best measured by high resolution peripheral quantitative computed tomography (HR-pQCT)).      The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be     observed only in the absence of local inflammation measured by Doppler ultrasound in the     erosion.      Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of     clinical improvement and structural damage (progression of radiographic lesions). Recent data     showed that there could be joint bone rebuilt in case of inflammation suppression. HR-pQCT is     a new technique emerging for bone erosions assessment in RA. Erosions size and volume could     be reduced with anti-TNF, but with a large interindividual variability. There was no     correlation between the activity of clinical or ultrasound synovium and evolution of erosion     HR-pQCT.   "
57642|NCT02531048|"     Different neurological damage may alter the pain conduction systems centrally (spinothalamic     pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal     stimulation selectively stimulates the pain pathways and generates nociceptive signals     conveyed to the cortex. Registering these cortical responses constitute the technical laser     nociceptive evoked potentials. If these tests are routinely used, their interpretation must     remain cautious especially in the elderly.   "
57646|NCT02530996|"     Systemic sclerosis (SSc; scleroderma) is a multi-organ systemic disease characterized by     activation of immune cells, which results in vascular dysfunction (vasculopathy) and     subsequent scarring (fibrosis). SSc has a higher than expect prevalence in the US military.     On a national level there are 5,766 SSc patients (ICD-9 710.1) presently cared for in the     Veterans Health Administration (VHA). While there is no cure for SSc, studies of therapeutics     that can help slow disease progression are valuable to our Veterans. This proposal addresses     the solicitation for projects with attention to SSc requested by President Obama after     reviewing potential contamination of water at Camp Lejeune. This proposal is a     patient-centered outreach for our Veterans with SSc to inform and prevent catastrophic     endstage vascular abnormalities, including digital ulcers, pulmonary arterial hypertension     (PAH) and scleroderma renal crisis in SSc. The study proposes a novel application of a     therapeutic for this disease. A better understanding of the initiating insult and natural     progression of SSc vasculopathy is needed in order to develop therapeutics with a goal of     curing/treating the underlying disease. This project has the potential to impact not only     Veterans with SSc, but also those with vascular abnormalities including digital ulcers, PAH,     and renal crisis. This proposal represents a potential major therapeutic advance for our     Veterans with SSc.   "
57647|NCT02530983|"     The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a     consistent evaluation tools for patients undergoing esophagectomy or esophageal     reconstruction in order to standardize and validate outcome measures. Data will be used to     establish the validation of the Mayo Clinic Conduit Report Card Questionnaires. Data will     also lead to the establishment of normal or expected scores for patients undergoing each     type of esophagectomy procedure   "
57648|NCT02530970|"     The objective of the SECURE Study is to actively gather additional information on the use of     the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.   "
57649|NCT02530957|"     Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with     severe life threatening complications. To decrease these complications, preoxygenation is     recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation,     applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC)     improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic     oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients has     never been evaluated. The aim of this study is to determine if HFNC combined to NIV could     have therapeutic advantages over NIV alone for preoxygenation in the ICU patients intubated     for hypoxemic acute respiratory failure.   "
57650|NCT02530944|"     The goal of this new lupus research study is two-fold: first, to understand the genetic     associations found between people's DNA and this disease, and second, to apply this     understanding to drug development efforts with the investigator's partners at Pfizer.   "
57651|NCT02530931|"     -  This prospective study aims to better characterize inner ear's perilymphatic structures          with Magnetic Resonance Imaging using contrast media and delayed injection in patient's          with Meniere's disease.        -  MR Perfusion Imaging will be assess in both cochlea as well        -  Primary auditory brain pathways will be evaluated through MR diffusion imaging   "
57653|NCT02530905|"     This is a first-in-human dose-titration and open-label extension study to assess safety,     tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy     (DMD) patients with deletions amenable to exon 45 skipping.   "
57654|NCT02530892|"     The purpose of this study is to determine whether embryo mechanical properties measured after     in vitro fertilization can predict clinical pregnancy.   "
57655|NCT02530879|"     This study will be a prospective, randomized, unblinded but controlled trial. Patients     presenting to the Otolaryngology clinic who are diagnosed with laryngopharyngeal reflux     disorder related dysphonia and meet inclusion criteria will be eligible to enroll in the     study. Subjects will be randomized to one of three treatment arms, voice therapy, anti-reflux     therapy, or a combination of voice therapy and anti-reflux therapy. Reflux symptom index     (RSI) scores, reflux finding scores (RFS), voice handicap index-10 (VHI-10) scores, and     consensus auditory perceptual evaluation-voice (CAPE-V) scores will be compared prior to     initiation of therapy as well as at 1, 2, and 3 months following initiation of treatment.   "
57656|NCT02530866|"     This is a randomized clinical pilot trial designed to assess the feasibility of randomizing     obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and     cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and     duration will also be compared between groups.   "
57657|NCT02530853|"     This is a randomized clinical trial with blinded, multi-center, involving the Federal     University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a     proponent and research coordinator; and as a collaborative educational institutions, the     Federal University of in Espirito Santo, represented by the Department of Nursing; and the     Higher School of Sciences of the Santa Casa de Misericordia of Vitoria, developed by building     doctorate thesis as a final product of the research.   "
57658|NCT02530840|"     In the IMPACT project, the investigators want to improve adherence and commitment to     treatment.   "
57659|NCT02530827|"     Background: Several studies have reported increased resting energy expenditure (REE) in     people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV     lipodystrophy syndrome.      The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in     resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive     for HIV in treatment of lipodystrophy.   "
57677|NCT02530593|"     All patients presenting at participating hospitals during the recruitment period with a newly     diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for     inclusion. They will answer a questionnaire on health related quality of life, physical     symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36     months. Clinical data including recurrence, survival, surgical treatment, oncologic result     (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal     Cancer Registry (SCRCR)   "
58384|NCT02521376|"     The primary objective of this study is to evaluate the pharmacokinetics of Entospletinib     (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function     (stratified by smoking status, as appropriate) relative to matched, healthy controls.   "
57660|NCT02530814|"     In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine     pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane,     toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests     and to improve crop harvests. For most of those years, the farmworkers were exposed to the     pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these     organochlorine pesticides (OCPs) are readily taken up into the body and not readily     eliminated. Therefore, they can be detected in exposed individuals for many years after the     exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems     in sensitive individuals. For example, exposure to some OCPs has been associated with     development of Parkinsonism. Exposure to other OCPs has been associated with development of     lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are     endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may     have mixed interactions with steroid receptors.      In this research study the investigators aim is to test the blood from former farmworkers     during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for     the auto-antibodies. In addition, questionnaires will provide insight on their health status     and health concerns.   "
57661|NCT02530801|"     Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it     is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by     causing astigmatism and may encroach on cornea (transparent part of the eye) affecting     vision. It could cause ocular irritation and can be cosmetically unacceptable especially when     inflamed.      Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium     vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of     your eye), before advancing on to the cornea. Treating the recurrent pterygium before the     cornea gets involved avoids repeat surgery, which is difficult and is associated with more     scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be     stopped before it progresses to true recurrence.      Several studies attributed the recurrence pf pterygium to the increase of substances as     vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF)     and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF     and fibroblast growth factor.      Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring     pterygium has been both safe and effective in treatment of recurrent pterygium.      In many cases, vascularization and inflammation were controlled by subconjunctival Avastin,     providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in     ophthalmology because of its anti-scarring properties.      The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a     challenging condition that usually resists conventional surgery and its rate of recurrence     after surgery is high. Moreover, recurrent pterygium surgery is usually accompanied by     scarring, more risk of intra and post- complications This study aims to generate data to     inform further studies towards establishing Avastin and 5 fluouracil as treatment modality     for recurrent pterygium.   "
57662|NCT02530788|"     This planned pilot study is a monocentric, prospective, double-blind randomized and placebo     controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.      The aim of the present trial is to provide the scientific rationale for a large multicenter     clinical trial, investigating the effects of perioperative high dose selenium supplementation     in high-risk cardiac surgical patients undergoing complicated open heart surgery with     prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators     hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a     faster independency from life-sustaining technologies in the ICU and a decrease of     postoperative morbidity and mortality. Before proceeding to the large-scale, definitive     trial, the investigators propose to conduct a pilot study of the definitive randomized trial,     to determine the feasibility of the study protocol.   "
57663|NCT02530775|"     The purpose of this study is to determine whether instrumented lumbar fusion provides     superior clinical outcomes in comparison to non-instrumented fusion in patients with static     degenerative spondylolisthesis.   "
57664|NCT02530762|"     The study will assess the gastrointestinal tolerability of a single serving of a novel     dietary fiber at three different dose levels in generally healthy men and women. Double-blind     controlled, cross-over clinical trial with negative (no added fiber) and positive controls.     Single dose, with 24 hours data collection and 1 week wash-out between cross-overs. 45     randomized, generally healthy men and women, 18-54 y, BMI higher or equal to 18.5 and smaller     or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control will be     delivered in 240 ml beverages.   "
57665|NCT02530749|"     Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been     evaluated. This study aims to determine if frailty predicts neurosurgical complications in     brain tumor patients and enhances current perioperative risk models.   "
57666|NCT02530736|"     This study measures the 4 metre gait speed (4MGS) test in patients with Idiopathic Pulmonary     Fibrosis (IPF). The investigators are interested to see whether usual walking speed in IPF     patients changes following pulmonary rehabilitation and if it changes, what is the smallest     change that is meaningful to patients.   "
57667|NCT02530723|"     Extending quality of life and attenuating functional decline is paramount in older adults.     This study investigates the effects of low-intensity power-training in older women and its     effects on functional outcomes.   "
57668|NCT02530710|"     Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and     female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1     - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo)     in a fasting state.      Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a     cohort, completes all procedures and none of the subjects has a clinically significant     adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related     serious adverse events (SAEs) have occurred.      A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100     mg dose level (this dose level may change based on PK analysis results). Subjects who     received 100mg dose in a fasting state will return and receive the second dose, with food.      Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.   "
57669|NCT02530697|"     Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries     worldwide. The standard treatment with meglumine antimoniate has a high rate of important     adverse effects. This interventional study consists in a randomized clinical trial to access     efficacy and safety of the association of miltefosine and pentoxifylline compared to     meglumine antimoniate and pentoxifyline.   "
57691|NCT02530411|"     A randomised double blind placebo controlled phase II study of fulvestrant with or without     the addition of vandetanib as treatment for patients with metastatic breast cancer resistant     to aromatase inhibitor therapy.   "
57670|NCT02530684|"     It is critical to improve our understanding of knee osteoarthritis and to design better     therapeutic options for this disease. The function of the knee during walking is an important     factor in the development and progression of the disease. Many models of insoles that can be     inserted in regular shoes with the objectives of improving the function of the knee are     available on the market without prescription. Prior studies on these insoles failed to report     clear benefits for the patients, mainly because the results varied strongly between persons.     Walking is a complex tasks and it is well known that everybody develops his/her individual     way of walking (ie., there are subtle but very important differences in the function of the     knee). This observation and the fact that patient responses could vary between individuals     suggest that using the same standard insoles with all patients might not be appropriated.     This further suggests that care could be greatly improved if it was possible to identify     patients that would respond positively to a model of insoles. Unfortunately, while several     randomized controlled trials were conducted on these insoles for knee osteoarthritis, there     is a paucity of data regarding their effects on the ambulatory function of the knee.     Therefore, this study aims to improve the understanding regarding the effects of insoles     freely available on the market in terms of knee mechanics during walking and its relation     with quality of life. This study will test the hypotheses that (i) insoles have an effect on     the static and dynamic lower-limb function and (ii) that benefits perceived by the patients     are related to the mechanical effects produced by the insoles.   "
57671|NCT02530671|"     Background: Clinical studies have explored the relationship between toothbrushing and the     development of recession, but relevant recession data for the multi-directional power     toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing     with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association)     reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over     12 months      Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized     controlled clinical study. Healthy participants without periodontitis but with at least 2     teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The     primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession     measurements were performed by one calibrated examiner at baseline, 6 and 12 months.     Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR),     changes in the percentage of recession sites demonstrating a change of ≥1mm as well as     changes in pocket probing depths.   "
58195|NCT02523846|"     The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique     for postoperative analgesia. Investigators are comparing between patient re-education and the     background morphine infusion among patients who fail to achieve satisfactory analgesia using     IV-PCA Morphine after laparotomy.   "
57672|NCT02530658|"     The development of next generation sequencing (NGS) techniques, including whole genome (WGS),     exome (WES) and RNA sequencing has revolutionized the ability of investigators to query the     molecular mechanisms underlying tumor formation. Through the Pediatric Cancer Genome Project     (PCGP), investigators at St. Jude Children's Research Hospital (SJCRH) have successfully used     NGS approaches to evaluate more than 1,000 pediatric cancers ranging from hematologic     malignancies to central nervous system (CNS) and non-CNS solid tumors. From these and related     studies, it has become clear that genomic approaches can accurately classify tumors into     distinct pathologic and prognostic subtypes and detect alterations in cellular pathways that     may serve as novel therapeutic targets. Collectively, these studies suggest that by     characterizing the genomic make-up of individual tumors, investigators will be able to     develop personalized and potentially more effective cancer treatments and/or preventive     measures.      Despite recent advances, NGS approaches are not yet routinely used as part of clinical care     due to their high cost and technical complexity, as well as the many challenges related to     data analysis and translation to the clinical setting. The overarching goal of this protocol     is to establish and test processes by which NGS technologies, including WGS, WES and RNA     sequencing, can be offered to pediatric oncology patients undergoing treatment at SJCRH.      This is a non-therapeutic study examining the feasibility, acceptance and impact of clinical     WGS, WES and RNA sequencing in a pediatric oncology setting. Investigators anticipate a     sample size of approximately 400 patients and 400-800 biological parents.   "
57673|NCT02530645|"     A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness     of OnTrack (a smartphone application to self-monitor substance use and sexual behaviors among     homeless young adults) plus a brief motivational intervention (BMI), in comparison to     treatment as usual (TAU) at Covenant House New York (CHNY) for those with substance abuse     problems and who engage in risky sex. Following referral, screening, and eligibility     determination, 60 participants will complete informed consent and be randomly assigned to one     of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at baseline,     2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption, marijuana use,     HIV sexual risk behaviors, and other relevant variables.   "
57674|NCT02530632|"     Effects of different general anesthetics on peripheral microcirculation.   "
57675|NCT02530619|"     The purpose of this study is to evaluate the safety of alisertib and its effect, bad and/or     good, on acute megakaryoblastic leukemia (AMKL) or myelofibrosis (MF). The study drug,     alisertib, is an investigational drug. An investigational drug is one that has not been     approved by the U.S. Food and Drug Administration (FDA). Alisertib has shown evidence in the     lab that it may have an effect on a type of cell that produces platelets. This cell is called     a megakaryocyte and it is known to be defective (doesn't work well) in both AMKL and MF.   "
57676|NCT02530606|"     This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian     or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to     light up tissue, and then converts the light information into ultrasound images.     Photoacoustic imaging can provide images of the structure of tissues, as well as their     function and the levels of molecules, such as the flow of blood in blood vessels and the     level of oxygen in the blood. Photoacoustic imaging may help doctors determine whether a mass     is benign (non-cancerous) or cancerous based on the molecular differences between cancer and     normal tissue. It may be more accurate and less expensive than other imaging methods, and     does not expose patients to radiation.   "
57678|NCT02530580|"     GABA (gamma-aminobutyric acid) is the main inhibitory neurotransmitter in the human brain.     For years, drugs that enhance its effects (e.g., benzodiazepines such as diazepam/Valium)     have been used to treat various diseases such as epilepsy, insomnia, anxiety or movement     disorders. However, the use of these medications is often compromised because of their side     effects, such as sleepiness, memory problems, and addiction.      Therefore, effort has been made to develop drugs that act more selectively in the brain to     exert the positive therapeutic effects and are devoid of the unwanted side effects. AZD7325     is one of these drugs. It has been tested in more than 700 people and so far proved to be     generally well tolerated. Positron emission tomography (PET) study in humans demonstrated     that AZD7325 binds to GABA A receptors in the brain after a single dose. Early clinical     studies have shown that it has less sedative and cognitive adverse events as compared with a     benzodiazepine lorazepam.      The investigators now wish to evaluate if effects of AZD7325 can be objectively measured in     healthy volunteers and to establish which of the drug's outcomes could be utilised for     further studies in patients with neurological diseases.      The investigators are especially interested in the effects of AZD7325 on manual dexterity and     skin sensation of the hand. This can be assessed by a number of simple non-invasive tests of     object manipulation and detection of different sensory stimuli such as touch, vibration, or     temperature. Recent studies show that healthy individuals who performed better in similar     tasks had more GABA in relevant areas of their brain. If performance in these tasks in     healthy volunteers can be improved by enhancing GABA effects in the brain with AZD7325, this     would create the grounds for the use of this medication to treat symptoms of certain     neurological disorders in which motor control and sensation of the hand is impaired (e.g.,     polyneuropathy).   "
57679|NCT02530567|"     The objective of this research is to study the correlation between the portosystemic pressure     gradient and azygos blood flow measured by MRI.   "
57680|NCT02530554|"     Pilot study to evaluate and compare activity of preoperative preparation with comparator   "
57681|NCT02530541|"     Pilot study to evaluate and compare activity of preoperative preparation with comparator   "
57682|NCT02530528|"     Pilot study to evaluate and compare activity of preoperative preparation with comparator.   "
57683|NCT02530515|"     Patient's immune systems are often damaged by chemotherapy or by CLL. Researchers want to     learn if giving T-cells (immune cells) that have been expanded and specially processed in the     laboratory (activated) will help CLL patients' immune systems recover after chemotherapy.     This may help lower the chance of infections.      The goal of this clinical research study is to learn if an activated T-cell infusion, when     given with or without lenalidomide, can help to restore patients' immune systems when given     after chemotherapy (rituximab and fludarabine with cyclophosphamide or bendamustine). The     safety of this treatment combination will also be studied.      Researchers also want to learn if the activated T-cells may also be able to kill cancer     cells.   "
57684|NCT02530502|"     The purpose of phase I trial is to determine the safest, most effective dose of MK-3475     (pembrolizumab), when used with radiotherapy and temozolomide for treating newly diagnosed     patients with glioblastoma (GBM). Phase II trial will evaluate if MK-3475 used in combination     with temozolomide and radiation followed by radiation and temozolomide to see if this is     better than using radiation and temozolomide alone. Temozolomide binds to the     deoxyribonucleic acid (DNA), changes it, and triggers the death of tumor cells. MK-3475 is an     investigational drug, it is not currently approved by the Federal Drug Administration (FDA)     for use in treating GBM but it is approved for treating melanoma. MK-3475 works by targets     the local tumor immune-protection in solid tumors. It is hoped the addition of MK-3475 to the     usual treatment for GBM will improve the current treatment.   "
57685|NCT02530489|"     The goal of this clinical research study is to learn if receiving atezolizumab and abraxane     (nab-paclitaxel) in combination before surgery and atezolizumab alone after surgery can help     to control breast cancer. The safety of this study drug combination will also be studied.   "
57686|NCT02530476|"     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).      The goal of Part 1 of this clinical research study is to find the highest tolerated dose of     the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients     with FLT3-ITD and -D835 mutated acute myeloid leukemia (AML) or FLT3-mutated high-risk     myelodysplastic syndrome (MDS).      The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control     the disease.      The safety of the drug combination will also be studied in both parts of this study.   "
57687|NCT02530463|"     The goal of this clinical research study is to learn if nivolumab and/or ipilimumab, with or     without azacitidine, are safe to give to patients with MDS. Researchers also want to learn if     the study drug combinations can help to control the disease.   "
57688|NCT02530450|"     The purpose of this study is to determine if the use of continuous glucose monitoring in a     practical outpatient clinic setting in children with poorly controlled diabetes will lead to     improved blood sugar control.   "
57689|NCT02530437|"     The goal of Phase 1B of this clinical research study is to find a dose of Taladegib that can     be given safely with the chemotherapy drugs carboplatin and paclitaxel and radiotherapy to     patients with esophageal or gastroesophageal junction cancer.      The goal of Phase 2 of this clinical research study is to learn if Taladegib given with     chemoradiation can help to control the disease. The safety of this treatment combination will     continue to be studied.   "
57690|NCT02530424|"     This is a multicenter neoadjuvant trial conducted under the sponsorship and overall trial     management of the Fondazione Michelangelo in Italy.      Women with a diagnosis of invasive unilateral non metastatic HER2-positive and ER-positive     breast cancer suitable for neoadjuvant therapy.      Patients in this study will receive: Trastuzumab+Pertuzumab+Palbociclib+Fulvestrant (HPPF)      Trastuzumab 8 mg/kg loading dose IV, then 6 mg/kg IV q.3 wks (repeat for a total of 6     administrations) Pertuzumab 840 mg loading dose IV, then 420 mg IV q. 3 wks (repeat for a     total of 6 administrations) Palbociclib 125 mg po q.d. x 21 q. 4 wks (= 1 cycle; repeat for a     total of 5 cycles) Fulvestrant will be given intra-muscle at the dose of 500 mg every 4 weeks     (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose     (total administrations including the additional one = 6)      The total duration of neoadjuvant palbociclib (5 cycles every 4 weeks) and fulvestrant (5     administrations every 4 weeks plus the additional dose given two weeks after the initial     dose) was selected to match as closely as possible the total duration of the six planned     3-weekly administrations of trastuzumab and pertuzumab      Definitive surgery will be performed not earlier than 14 days and not later than 28 days     after the last dose of any of the drugs in the combination reported above      After completion of the neoadjuvant and surgical treatment patients will receive irradiation     as locally acceptable.      Patients will also continue to receive systemic drug therapy including chemotherapy, and     standard HER2 treatment until completion of full 1 year and endocrine therapy according to     local guidelines at the Investigator's discretion.   "
57696|NCT02530346|"     This study will help determine wether mechanical bowel preparation before a colostomy closure     is necessary in pediatric population, in order to avoid surgery related complications     (surgical site infection and anastomosis leakage).      Half of the population will go through the mechanical bowel prep before colostomy closure and     the other half won´t. Complications rate will be compared among both groups.   "
57764|NCT02529462|"     This study evaluates the efficacy of NEUROPHARMAGEN pharmacogenetic test in the selection of     the pharmacological treatments for patients with Major Depressive Disorder (MDD), both with     and without psychiatric comorbidities. Patients will be randomly asigned to test-guided     treatment prescription or to treatment as usual ina a 1:1 ratio; the results of the test will     not be disclosed to the later until the end of the 3-month follow-up period. The study will     compare the rate of treatment responders among both groups, based on patient-reported     improvement collected by blind telephone interview.   "
57697|NCT02530333|"     Anterior cruciate ligament injury programs are less successful in women's basketball than     soccer players, yet the reason for this discrepancy is unknown. Thus, this study will recruit     high school aged girl's basketball and soccer players, randomized teams into control and     experimental groups, administer an ACL injury prevention program in the experimental group     and compare the two groups on their lower extremity biomechanics before and after completion     of the program. Biomechanical analyses will help determine the extent to which women's     basketball and soccer players respond differently to a uniform injury prevention program, and     whether this prevention program provides an adequate stimulus to improve lower extremity     biomechanics during basketball-specific tasks.   "
57698|NCT02530320|"     This multicenter, open-label, phase II trial aims to assess the safety and efficacy of     palbociclib in adult patients with Oligodendroglioma or recurrent oligoastrocytoma anaplastic     with the activity of the protein RB preserved.   "
57699|NCT02530307|"     This is a randomized, double-blind, placebo-controlled parallel group outpatient study that     will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a     subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in     medically stable subjects following ischemic stroke.   "
57700|NCT02530294|"     The study is a randomized, double-blind, vehicle controlled, parallel group study, designed     to assess the efficacy and safety of DRM04 Topical Wipes, once daily, compared to vehicle in     subjects with axillary hyperhidrosis.   "
57701|NCT02530281|"     The study is a randomized, double-blind, vehicle controlled, parallel group study, designed     to assess the efficacy and safety of DRM04 Topical Wipes, once daily, compared to vehicle in     subjects with axillary hyperhidrosis.   "
57702|NCT02530268|"     This prospective, non-interventional, research registry is designed to study the comparative     effectiveness and comparative safety of approved treatments for PsA-SpA in a cohort of     patients cared for by rheumatologists across North America. Secondary objectives include     analyzing the epidemiology and natural history of the disease, its comorbidities, and current     treatment practices.   "
57703|NCT02530255|"     A method of detecting amyloid in the retina has been developed. A specially designed retinal     camera will directly visualze and record retinal amyloid and via image processing will     generate a number: the retinal amyloid index (RAI). The amount of retinal amyloid correlates     with cerebral amyloid and has a predictive value in Alzheimer's disease.      Telomere attrition accounts for cellular aging and is felt to have a pivotal role in     Alzheimer's disease. The investigators plan to screen individuals to select those having     retinal amyloid then evaluate an oral telomerase activator to determine if its use can alter     the RAI over time compared to placebo.   "
57704|NCT02530242|"     Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO     (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature     conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).   "
57705|NCT02530229|"     The purpose of this study is to analyze pre- and intra-operative joint aspirates of native     joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and     shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic     methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these     methods is compared to standard diagnostic methods in clinical routine, such as blood     cultures of joint aspirates, cell count/differential, intra-operative tissue culture and     histology and sonication.   "
57706|NCT02530216|"     Healthcare delivery now mandates shorter visits with higher documentation requirements,     undermining the patient-provider interaction. Electronic health records (EHRs) have the     potential to improve outcomes and quality of care in this pressured environment, and are     endorsed by the Patient Protection and Affordable Care Act (ACA) and Health Information     Technology for Economic and Clinical Health (HITECH) Act as an important mechanism to support     value-based healthcare. However, EHR systems were principally designed to support the     transactional needs of administrators and billers, less so to nurture the relationship     between patients and their providers. The purpose of this research is to identify ways to use     EHRs to support clinical gastroenterologists and their patients while meeting the meaningful     use requirements of the HITECH Act.      To improve clinic visit efficiency and meet criteria for meaningful use, investigators     developed a patient-provider portal (P3) that systematically collects patient symptoms using     a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS     utilizes computerized adaptive testing (CAT) to guide patients through questions drawn from a     library of over 300 symptom attributes measuring the timing, severity, frequency, location,     quality, and character of their GI symptoms, along with relevant comorbidities, family     history, and alarm features. The system then automatically translates the patient report     into a full narrative HPI available for use by GI providers in an EHR.      In a cross-sectional study in the American Journal of Gastroenterology comparing AEGIS versus     physician-documented HPIs, investigators found that blinded physician reviewers perceived     that AEGIS HPIs were of higher overall quality, better organized, and more succinct,     comprehensible, complete and useful compared to HPIs written by physicians during usual care     in academic GI clinics. In the current study, investigators aim to evaluate     computer-generated HPIs prospectively on a wider scale in diverse academic and     community-based settings. Moreover, investigators aim to test an enhanced AEGIS intervention     that ties patient HPIs to an individualized education prescription which guides the patient     through a library of multi-media educational materials on GI symptoms, conditions, and     treatments.   "
57707|NCT02530203|"     Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate     the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days     after surgery.   "
57708|NCT02530190|"     The study is a randomized clinical trial examining the effectiveness of massage and     intermittent pneumatic compression on recovery from a 161-km ultramarathon.   "
96012|NCT02029430|"     This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV     positive subjects with Kaposi's sarcoma.   "
57709|NCT02530177|"     The purpose of this study is to see how many patients develop hair, skin and nail changes due     to cancer treatments. The investigators would like to study the clinical factors, genetic     markers, and impact on patients' health-related quality of life to learn more about who is at     greater risk. We trust that the study will improve our understanding of how cancer patients     feel about their skin, hair, and nail conditions. This information will help us determine the     burden on breast cancer patients and survivors. It will also help us learn how to prevent     these conditions and it may improve the way we treat them and counsel patients.   "
57765|NCT02529449|"     The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of     ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2     weeks.   "
58216|NCT02523573|"     Bronchoscopy with bronchoalveolar lavage (BAL) is at risk for worsening hypoxemia in patients     with acute respiratory failure (ARF). High-flow nasal cannula oxygen (HFNC) improves     hypoxemia in ARF patients . We investigated its efficacy and tolerance in intensive care unit     patients admitted for ARF requiring BAL.   "
57710|NCT02530164|"     Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder.     Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently     from existing antidepressant interventions including trials of medication and psychotherapy.     A 15-25% of patients manifest a chronic, treatment-resistant course of illness, resulting in     a need for additional treatment options. Brain stimulation techniques are considered as a     promising therapeutic approach in affective disorders like MDD. Transcranial direct current     stimulation (tDCS) is a non-invasive brain stimulation method that has been largely     investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been     proposed as novel treatment in MDD. In the largest 2x2 factorial randomized controlled trial     in MDD to date, Brunoni et al. (2013) have shown that tDCS combined with an Selective     Serotonin Reuptake Inhibitor (SSRI; sertraline) resulted in an antidepressant efficacy     superior to placebo treatment, tDCS alone and sertraline alone.      The purpose of this study is to explore the sustained efficacy and tolerability of repeated     tDCS for the treatment of MDD. It is hypothesized that prefrontal tDCS in combination with an     SSRI will provoke an antidepressant effect while antidepressant medication alone (sham tDCS)     did not. This will be measured by the change from baseline in the Montgomery Åsberg     Depression Rating Scale (MADRS) scores after 6 weeks of treatment.      In this randomized, placebo-controlled multicenter trial (5 centers involved) patients with a     diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS (anode over electrode     position F3, cathode over F4, 5 sessions/week for 4 weeks followed by 2 sessions/week for 2     weeks, 24 treatments in sum, 30min/day, 2mA intensity) or sham tDCS (frequency and duration     correspondent active tDCS, ramp in and ramp out periods only without intermittent     stimulation), as adjunctive treatment with a SSRI. Follow-up per patient is 3 and 6 months     after the last tDCS treatment session. Before, during and after the treatment period     different assessment scales will be conducted to record neuropsychological features and the     course of the individual symptomatology.   "
57711|NCT02530151|"     The purpose of this study is to determine whether intraoperative (during surgery) morphine     and clonidine hip injections are effective in postoperative pain management for patients     undergoing hip arthroscopy.   "
57712|NCT02530138|"     Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver     disease in the world. The only approved treatment for it is lifestyle modification and weight     loss; however, there is no evidence for patients with normal or low body mass index (BMI).      The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD     patients with normal or low BMI.      Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial     protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42     patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a     placebo capsule. Both groups will be advised to follow an energy balanced diet and physical     activity recommendations.   "
57713|NCT02530125|"     The purpose of this study is to evaluate pidilizumab and its effect, bad and/or good, on the     immune system in relation to its ability to fight cancer cells. Many cancers can be brought     to a phase called complete remission (no cancer is found) but have a chance that they may     come back. Researchers are working to improve therapy and to find new drugs that lower the     chance of disease coming back. This study uses a drug called pidilizumab. The drug targets     our immune system. It can change how our immune system finds cancer cells. The drug may kill     any remaining cancer cells that we cannot see with computed tomography (CT) scans. The drug,     pidilizumab, is being studied in other cancers.   "
57714|NCT02530112|"     To identify outcome measures for cancer control in Head and Neck cancer patient populations     at the University of Pennsylvania (HUP, PAH, Presby) by administering various functional     outcome surveys and questionnaires about their reconstructive surgery. We hope to ultimately     develop a QOL indicator that will reflect the impact of reconstructive surgery on patient's     quality of life, and help with therapeutic interventions and explanation of expectations     prior to surgery.   "
57715|NCT02530099|"     Often the less experienced as medical students are charged with the role as camera navigator     and assistant during laparoscopic surgery. Camera navigation is generally considered an easy     skill, but it requires specific psychomotor and visuospatial skills. Simulation-based     training can improve surgical skills, but little is known on how to optimally structure a     training program to acquire camera navigation skills. The objective of this trial is to     examine if simulation-based laparoscopic camera navigation skills transfer to the operating     room after practicing one of two fundamentally different laparoscopic tasks on a simulator.     The first group practice a procedure on a virtual reality simulator, the second group     practice camera navigation on a virtual reality simulator and the third group receive no     training. All participants are tested as camera navigators and assistants during a procedure     in the operating room.   "
57716|NCT02530086|"     A prospective randomized trial comparing non-operative management of small bowel obstruction     due to adhesions with or without a naso-gastric tube (NGT).   "
57717|NCT02530073|"     The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore     adequate lung growth for neonatal survival.   "
57718|NCT02530060|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of     rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of     Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate [TDF]) to     healthy Japanese adult male participants.   "
57719|NCT02530047|"     The goal of this clinical research study is to find the highest tolerable dose of human     mesenchymal stem cells with interferon beta (MSC-INFβ) that can be given to patients with     ovarian cancer and to test the safety of the MSC-INFβ.   "
57720|NCT02530034|"     The goal of this clinical research study is to find the highest tolerable dose of Hu8F4 that     can be given to patients with advanced leukemia.      This is the first study using Hu8F4 in humans.   "
57721|NCT02530021|"     There are many patients hospitalized for chest pain, which don't have high risk features that     require invasive coronary angiography, but are considered intermediate risk and for which     ischemic heart disease can not be excluded.      The current management for these patients is to perform a non invasive test in order to     classify their risk.      Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is     non-invasive, and does not involve radiation or intra-venous contrast. The test is limited     for many patients, because of un-ability to exercise, or because of non-interpetable Electro     Cardio-Graphy (ECG).      Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate     variability testing is a non-invasive ECG monitoring technique.      The study design is to identify hospitalized patients who are candidates for non-invasive     stress testing, and to monitor their heart rate variability for one hour prior to the stress     test.   "
58217|NCT02523560|"     Applying modern technology of data collecting, monitoring, transmitting and analyzing in     order to implement a novel (hybrid) model of comprehensive home-based cardiac rehabilitation     in heart failure patients.   "
57722|NCT02530008|"     This is a cohort study of women with suspected or confirmed recurrent breast cancer, with     accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent     metastatic disease. Study participants will be ascertained from the population of all persons     greater than eighteen years of age receiving care at the clinical practices of the Rowan     Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this study is     to identify the genetic and molecular markers of molecular evolution identified in patients     who have progressed from a primary diagnosis of breast cancer to recurrent, metastatic     disease. As an observational study, this study seeks to gather data regarding the molecular     and genetic changes that a primary cancer undergoes as a patient's cancer recurs and     ultimately progresses. We anticipate enrolling 50 women with recurrent breast cancer who meet     eligibility requirements for this study. Participation in this study will include the     following: a biopsy and blood collection, completion of the study questionnaire, an optional     bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a     optional bone marrow aspirate collection at each progression time point. The study     participants' medical information will be updated and changes in disease status will be     captured on a regular basis.   "
57723|NCT02529995|"     A Phase I, Open-Label, Two Parts Study to Assess the Safety, Tolerability,Pharmacokinetics     and Preliminary Anti-tumour Activity of AZD9291 in Chinese Patients with Advanced Non-Small     Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor     Receptor Tyrosine Kinase Inhibitor Agent      Study Objective: 1, Primary Objective To characterise the pharmacokinetics (PK) of AZD9291     and its metabolites (AZ5104 and AZ7550) after single then multiple doses of AZD9291     administered orally once daily in Chinese patients with locally advanced or metastatic non     small cell lung Cancer (NSCLC) who have progressed following prior therapy with an approved     Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) agent.      2, Secondary objective(s) To investigate the safety and tolerability of AZD9291 when given     orally to Chinese patients with locally advanced or metastatic NSCLC who have progressed     following prior therapy with an approved EGFR TKI agent. To obtain a preliminary assessment     of the anti-tumour activity of AZD9291 by evaluation of tumour response using Response     Evaluation Criteria in Solid Tumours (RECIST) version 1.1.   "
57724|NCT02529982|"     Diabetes mellitus is the most common endocrine disorder, causes many complications such as     micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed,     but most of them have side effects. Recently, the use of natural plant products has gained     more attention among scientists in order to prevent diabetic vascular complications. Curcumin     is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic     and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory,     anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic     index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the     studies conducted on animal model, and just a few of them are on human model. The present     study was planned to evaluate the effects of curcumin supplementation on serum levels of     glycemic control, lipid profile, inflammatory markers, and oxidative stress in patients with     type 2 diabetes   "
57725|NCT02529969|"     Diabetes mellitus is the most common endocrine disorder, causes many complications such as     micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed,     but most of them have side effects. Recently, the use of natural plant products has gained     more attention among scientists in order to prevent diabetic vascular complications. Curcumin     is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic     and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory,     anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic     index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the     studies conducted on animal model, and just a few of them are on human model. The present     study was planned to evaluate the effects of curcumin supplementation on serum levels of     lipid profile and inflammatory markers in patients with type 2 diabetes   "
57726|NCT02529956|"     To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in     subjects with mild to moderate plaque psoriasis.   "
57727|NCT02529943|"     Is there a relationship between changes in motor evoked potential latency intraoperatively     and post-operative changes in walking function in patients undergoing spinal decompression.   "
57728|NCT02529930|"     This is an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in     patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This study     will recruit approximately 27-40 female patients with high grade cervical intraepithelial     neoplasia (HSIL, CIN 2/3) at multiple sites in Europe.   "
57797|NCT02529033|"     The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac     output) is as equivalent in determining the hemodynamic assessment in cardiac surgical     scenarios as the most often used pulmonary artery catheter, which is much more invasive than     the Lidco Rapid. This will be accomplished through online surveys which have different     cardiac surgery scenarios and will be distributed to cardiac fellowship trained     anesthesiologists. The online based survey will include a specific scenario and details on     the scenario represented in image format and a brief description of the patient to aid with     their analysis of the situation.   "
57729|NCT02529917|"     Forty physically active men and women aged 18-45y will take part in an 8-week resistance     training program, randomized (double blind) 1:1 into each of two groups. Twenty participants     will be randomized to receive 60 g/d of hemp powder (containing approximately 40 g protein     and 9 g oil) supplementation and 20 randomized to receive 60 g/d of soy supplementation     (matched to the hemp for macronutrients and calories) during eight weeks of training. Each     participant will complete testing before and after the intervention for assessment of body     composition (lean tissue, fat, and bone mass), strength, central fatigue, markers of     inflammation, and bone resorption. Over the 8-weeks of training, participants will train     four-five days per week for 1-1.5 hours per session with exercises targeting all major muscle     groups. The training will involve a two day split where different muscle groups are trained     on two consecutive days (day 1 involves chest, back, and arms; day 2 legs, shoulders, and     abdominals). Resistance training will provide the necessary stimulus for protein synthesis to     optimize the effect of a protein-containing nutritional supplement. The hemp or soy powder     will be consumed in two doses (i.e. 30 g powder containing 20 g protein per dose) immediately     after exercise sessions and one hour after exercise. This dosing regimen is optimal for     stimulating muscle protein synthesis and building muscle mass . On the one non-training day     per week the two doses will be consumed with meals.   "
57988|NCT02526550|"     This study was undertaken to assess the immunogenicity and safety of a booster dose of a live     attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with     SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the     duration interval after primary vaccination on subsequent booster response.   "
57730|NCT02529904|"     Influenza infection is related to significant morbidity and mortality in children. The     trivalent inactive vaccine (TIV) has been documented to have poor immunogenicity in children     and the live attenuated influenza vaccine (ATIV) although proven to have more efficacy is     unable to be administered to children under 2 years old. The MF59 adjuvanted influenza     vaccine as proven efficacy on reducing the rates of laboratory confirmed influenza, including     in children.      The study aims to assess early gene transcriptional responses to priming and boosting with     MF59-ATIV in children aged 13-24 months and adults aged 18 - 65 years, and to establish     correlations with haemagglutination inhibition (HAI) titers. It will be an open label study     with 90 healthy children allocated to 3 groups (groups 1, 2 and 3) and 30 healthy adults     allocated to group 4.   "
57731|NCT02529891|"     Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD),     affecting the decline of pulmonary function, quality of life and increasing morbidity. The     use of validated biomarkers could help to identify the etiology of exacerbation and to     prescribe antibiotherapy when indicated.      The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which     reflect local or systemic inflammation and oxidative stress. The relationship between the     presence of some of these compounds and the exacerbation of COPD has never been studied.      The aim of this study is to identify a cluster of VOC in COPD patients during an acute     exacerbation of the disease, compared to a stable condition (3 months after discharge).     Investigators also will seek for a relationship between VOC and the etiology of exacerbation     (bacterial, viral, inflammatory).   "
57732|NCT02529878|"     The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an     initially unresectable gastric cancer to a resectable cancer. Previous studies showed     patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and     subsequent curative surgery. The key of conversion therapy of initially unresectable     metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF     receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The     purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy     plus Apatinib in the conversion therapys of metastatic gastric cancer.   "
57733|NCT02529865|"     The purpose of this study is to evaluate the efficacy and safety of periurethral injection of     autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.   "
57734|NCT02529852|"     There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion).      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin,     vincristine, and prednisone) that can be given to patients with diffuse large B cell     lymphoma.      The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found     in Part 1 can help to control the disease.      The safety of this drug combination will be studied in both parts.   "
57735|NCT02529839|"     The purpose of this study is to evaluate the safety and efficacy of an immunoablative     nonmyeloablative conditioning protocol for autologous bone marrow transplantation in patients     with Multiple Sclerosis. Patients meeting inclusion and exclusion criteria will start an     immunoablative nonmyeloablative conditioning regimen followed by autologous bone marrow     transplantation. Patients will be followed for one year by a neurologist to evaluate the     course of the disease after treatment.   "
57736|NCT02529826|"     Due to remarkable advances in cancer treatments, the investigators are witnessing a growing     population of long-term survivors of childhood malignancies. However, fertility in adult life     may be severely impaired by gonadotoxic therapies. Since prepubertal boys cannot produce     spermatozoa, banking of testicular tissue prior to gonadotoxic treatment is a crucial step     towards fertility preservation for this population. Several centers around the world are now     cryopreserving testicular tissue for prepubertal boys in anticipation that future     technologies will allow the utilization of the banked samples for fertility restoration.      Testicular tissue cryopreservation has now emerged as the leading strategy for fertility     preservation in prepubertal boys before gonadotoxic treatments. Fertility restoration can     theoretically be obtained after allo-transplantation of testicular tissue fragments that     preserve both the SSCs and the supporting microenvironment (spermatogonial stem-cell niche).   "
57798|NCT02529020|"     The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece     require additional research to assess its impact on anaerobic ability and ventilatory     parameters. This study was aimed at determining the ergogenic acute effects of wearing a     custom-made mouthpiece on oral airflow dynamics, Wingate Test performance parameters.   "
96973|NCT02016885|"     The purpose of this study is to evaluate the safety and efficacy of DRM04B compared to     vehicle for the treatment of axillary hyperhidrosis.   "
57737|NCT02529813|"     Sometimes researchers change the DNA (genetic material in cells) of donated T-cells (white     blood cells that support the immune system) using a process called gene transfer. Gene     transfer involves drawing blood from the patient, and then separating out the T-cells using a     machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject     the changed T-cells into the body of the patient.      The goal of this clinical research study is to find the highest tolerable dose of genetically     changed T-cells that can be given to patients. Researchers want to learn if these genetically     changed T-cells may be able to attack cancer cells in patients with advanced B-cell lymphoma     or leukemia.   "
57738|NCT02529800|"     To investigate the PK charateristics and the effect of food on the PK in healthy male     volunteers who receive HIP1402 capsule in fed versus fasted condition   "
57739|NCT02529787|"     Comparative randomized, single dose, two-way crossover open-label study to determine the     bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and     Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)   "
57740|NCT02529774|"     This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant     systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete     hepatic resection for Chinese patients with metastatic colorectal cancer.   "
57741|NCT02529761|"     This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE combined     with sorafenib compared with TACE monotherapy in term of overall survival in     intermediate-stage HCC.   "
57776|NCT02529306|"     Many type 2 diabetic men have low serum testosterone levels. Our aim in this trial is to     check if there is a correlation between serum or hair testosteron levels and serum or hair     cortisol levels in type 2 diabetic men. We'll also examine whether there is a correlation     between serum and hair testosterone levels and cortisol levels and serum inflammatory     markers.      If such correlation will be found- then it is possible that excess cortisol or an abnormal     inflammatory status- may cause the low testosterone levels that seen in type 2 diabetic men.   "
57742|NCT02529748|"     Dermal transfer efficiency has been defined as the amount of material that moves from one     surface to another following contact. The investigators propose to measure dermal transfer     efficiency for the following pathways: (1) object to skin, (2) skin to skin, (3) skin to     mouth, (4) clothing to skin, (5) gloves to skin, and (6) air to skin. First, the quantitative     dermal transfer will be measured for the two selected test substances (lead, Tinopal) for     each of these six pathways. The relative quantities of dermal transfer will also then be     compared between the different transfer pathways (e.g., is skin to skin transfer greater or     less than clothing to skin transfer?). And second, the pattern of transfer will be     characterized semi-quantitatively (e.g., does dermal transfer occur consistently and evenly     to the skin from different reservoirs?).   "
57743|NCT02529735|"     Non-invasive measurement of blood pressure is an instrument governed nursing routine care.     The use of an automated oscillometric cuff is a common technique and validated if this is     done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the     right atrium (the brachial site) . If cons-indication to use the brachial site, measurements     are frequently performed at the ankle, calf or thigh. Among the blood pressure values     measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific     property of which the observed values are closest to the reference values (brachial).      The objective of this study is to measure the non-invasive blood pressure values at three     sites of the lower limb, to compare the reference value to determine which alternative site     should be preferred when the reference measurement is not feasible .      We want to determine the alternative site to obtain values as close as the measured values of     the reference site. The three study sites are the thigh, calf and ankle. The reference site     recommended for monitoring non-invasive blood pressureis the arm.      It is also assessing the impact of certain parameters on the primary endpoint:        -  Physiological parameters: gender, weight, height, age, systolic blood pressure          reference, listed measures.        -  A parameter related to measurement: discomfort felt when the blood pressure outlet.        -  Exposure setting: smoking.   "
57744|NCT02529722|"     IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an     important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per     million age-related population in adults and 3-5/new cases/year/per million age-related     population in children and progresses to need of renal replacement treatment in 5-15% at 10     years and in about 20% at 20 years. The variability of the clinical course anticipates     different treatment options. There is an absolute need of validated biomarkers to predict     risk of progression and indication for treatment at early stages, when lesions can be     reversible. This study aimed to evaluate IgAN progression and its histological and clinical     correlates.   "
57745|NCT02529709|"     The purpose of this study is to see if a high-protein meal leads to a better postprandial     (after a meal) blood lipid profile compared to a high-monounsaturated meal.   "
57746|NCT02529696|"     Maintenance of analgesia during a patient stay in the hospital has been an important area of     investigation after demonstrating a direct correlation between level of sedation and     mortality in the ICU setting. This study will investigate the use of accelerometers in     determining patient sedation level.   "
57747|NCT02529683|"     One arm clinical trial of Nuvaring use for six months among 200 previously contracepting     HIV-negative women (COCPs or DMPA) aged 18-35 in Kenya, where no vaginal rings are     licensed/available for contraception or other indications. This was meant to be a formative     research study to understand the predictors of acceptability and adherence to a contraceptive     vaginal ring, and its immunoogical and microbiological effects over six months of product     use.   "
57770|NCT02529384|"     Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is     still challenge for radiologist. This study is going to evaluate multi-b value diffusion     weighted imaging in discrimination of breast benign and malignant lesions and explore the     diagnostic effect of the combination of multi-parameter. At the same time, pathological     specimens of patients will be collected. The relationship between magnetic resonance(MR)     parameters and pathology biomarkers will be evaluated. Hope multi-b value diffusion weighted     imaging can improve diagnosis for breast lesion and provide the basis for clinical treatment.     The fundamental of pathology on MR signal change will be further expounded.   "
57748|NCT02529670|"     Chronic axial low back pain is a public health problem and has a high socioeconomic impact.     The dorsal ganglion of the second spinal nerve (GDL2) is a cluster of neuronal bodies     responsible for sensory afferent inputs from more than 80% of the lumbar region. Low-level     laser therapy (LLLT) is proven effective to help relieve pain. Thus, the aim of this project     is to determine the effect of LLLT on GDL2 when applied to assist in the diagnosis and     treatment of chronic axial low back pain. Methodology: 45 patients will be randomized into     three groups: laser, radiofrequency and local anesthetic. The patient will be positioned in a     prone horizontal position under anesthetic monitoring. The intervertebral foramen between the     second and third lumbar vertebrae will be accessed by percutaneous puncture guided by     fluoroscopy. In the local anesthetic group, injection of 1 ml lidocaine without     vasoconstrictor will be applied in the tubes G20, 150 mm long and 5 mm active tip in contact     with the target. In the radiofrequency group, neuromodulation will be held for 300 seconds at     42oC. In the laser group, the laser Photon III® (DCM) will be applied through optic fiber     crossing G18 cannulas, during 84 seconds. The pain score will be assessed by visual analog     scale. Temperature will be measured and aspirate periganglionic sample, trans-operatively, to     study Interleucins-1β and TNF-alpha assessed by ELISA and genetic evaluation trough RNA seek,     RNA isolation and ATP quantification. The data will be evaluated for normality and subjected     to appropriate statistical analysis, in order to seek representation, as same as the level of     significance of the studied samples.   "
57759|NCT02529527|"     Strong evidence supports that preconception care, or care to optimize a woman's health health     prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a     broad range of topics, including: desire for pregnancy, obstetric history, nutrition,     vaccinations, sexual health, chronic disease, substance abuse, mental health and     contraception. Despite calls from public health organizations and experts in the field for     universal access to preconception care, most US women do not receive any health counseling to     prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is     critical that routine primary care serve as a venue for the provision of this important     service. From a patient's perspective, improving preconception health involves many health     behavior changes. As such, patient engagement and education regarding preconception health     must be a primary focus. Several preconception health promotion tools have been developed for     patients to date; few are truly patient-centered and even fewer have been rigorously     evaluated.      This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health     education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is     truly innovative in two key ways:        -  MyFamilyPlan is a web-based preconception health self-assessment. This will allow for          the employment of skip logic to individualize the questionnaire and subsequent health          recommendations for each patient.        -  Recognizing that preconception care is relevant to all women at risk of pregnancy,          MyFamilyPlan has been designed for utilization in a primary care setting.      This preconception health education tool will be tested using a randomized controlled design.     This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of     preconception health issues in primary care encounters (primary outcome). It will also     evaluate whether the intervention affects participant self-efficacy in planning a healthy     pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will     improve the quality of evidence for preconception health education tools. Should it     demonstrate effectiveness, it will also result in a new tool that could be made more widely     available to promote preconception health.   "
57749|NCT02529657|"     Each year, more than one million individuals worldwide are submitted to laminectomies, with a     failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause     of ''failed back surgery syndrome'' and associated with increased risk of complications     during revision surgery. The postoperative epidural scar can cause extradural compression or     dural tethering, which results in recurrent radicular pain and physical impairment. Several     studies in the literature are signalizing that Low-Level-Laser-Therapy (LLLT) is proven to be     an effective tool to assist the inflammatory process and wound healing, as well to prevent     infection. Thus, the objectives of this project are to delineate and evaluate the LLLT     effects in spinal surgery. A prospective randomized, controlled trial with a total of 48     patients who underwent laminectomy, were divided into 2 groups. In the first group, 25     patients received LLLT during the surgical procedure over dura mater, over subcutaneous and     on the skin, as well as 24h and 72h post surgery. In the second group, 23 patients were     induced to think they will be getting the same treatment, although the laser is not     operating. In those groups, C reactive protein, Lactate Dehydrogenase and Creatine kinase     were evaluated in the second and fifth days after surgery, digital temperature will be     measured and scores in visual analogue scale will be used, 5 minutes pre and 5 minutes post     Laser application. The drainage output was collected in the first three days following     surgery in both groups. Interleukins were evaluated in interstitial infiltrate drained in 24h     and 48h. The data was evaluated for normality and subjected to appropriate statistical     analysis, in order to seek representation, as same as the level of significance of the     studied samples.   "
57750|NCT02529644|"     The primary aim of this study is to fully test a culturally/religiously-tailored,     church-based HIV screening intervention (TIPS) against a standard HIV information     intervention on HIV screening rates at 6 and 12 months with adult African American church     members and community members who use church outreach services. Our secondary outcome is to     reduce sexual risk behaviors with this same population.   "
57751|NCT02529631|"     This trial compares two treatment methods:        1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in          overweight adults. Important is also that it is taken along with a reduced-calorie and          low-fat diet.        2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main          meals with the highest fat content, indicated for weight maintenance and weight loss.   "
57752|NCT02529618|"     The purpose of this study is to assess a new screening tool for sideline evaluation of     concussion injuries in athletes. iDETECT is a new technology that combines several elements     of recommended concussion screening tools into a single, portable device.   "
57753|NCT02529605|"     This is a single dose, randomized, cross-over pharmacokinetic study in healthy volunteers     (n=12) of two dietary supplement formulations. The Product B® IsaGenesis® formulation     represents a newer reformulation of an existing product known simply as IsaGenesis®. Beyond     some changes in the relative abundance of some of the constituents of the earlier IsaGenesis®     formulation, the Product B® IsaGenesis® product has been formulated as a liquid-gel     formulation (rather than a dried powder extract) which is theorized to enhance the absorption     and bioavailability of the contained botanical constituents. The purpose of this study is to     compare the two dietary supplement formulations relative to the absorption of two compounds     contained within the supplement known as the flavonolignans silybin A and silybin B into the     bloodstream after oral administration of capsules.   "
57771|NCT02529371|"     The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA     cleared non-invasive urine collection device for men.   "
57754|NCT02529592|"     The objective of the present study is to specifically assess the effect of lipopolysaccharide     (LPS) administration on the development of behavioral symptoms and the underlying     contribution of inflammatory processes. In particular, the investigators will assess the     development of subjective and objective behavioral symptoms. In addition, the investigators     will determine whether some psychological trait or state can predict and/or modulate the     LPS-induced inflammatory and behavioral responses.      Twenty-five healthy subjects will be included. A placebo-controlled, double-blinded and     cross-over design will be used. Subjects will receive an intravenous injection of endotoxin     at 2 nanogram/kilogram (ng/kg) of body weight and an intravenous injection of sodium chloride     as placebo of endotoxin injection at two different occasions.      Prior to inclusion and randomization, subjects will come at the hospital and will receive a     medical examination. Psychological variables that could affect the behavioral (or immune)     response to LPS will be assessed at that time, using several self-assessment questionnaires.      On the trial days, injection of endotoxin or sodium chloride will be performed and blood     samples will be taken just before the endotoxin or sodium chloride injection and 1, 1.5, 2,     3, 4, 5, 6 and 7.5 hours after the injection. Blood samples will be used to measure several     inflammatory and immune markers. Urine samples will be taken before the endotoxin or sodium     chloride injection and as late as possible after the injection. Subjects will wear T-shirt     all day. Urine and T-shirt samples will be used for behavioral assessment and analysis of     body odor compound.      Self-assessment questionnaires assessing behavioral and psychological variables will be     completed by participants just before the endotoxin or sodium chloride injection, three hours     and 7.5 hours after the injection. A short questionnaire assessing sickness behavior     (SicknessQ) will be repeatedly completed by participants from just before to 7.5 hours after     the endotoxin or sodium chloride injection.      Several behavioral tests will be used, including a motivation task, a test assessing     behavioral response to negative and sickness stimuli. Analysis of gait and motion, as well as     of social interactions, will be performed. Photographs will be taken for the further rating     of the faces.   "
57755|NCT02529579|"     The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined     gemcitabine therapy on advanced pancreatic cancer.   "
57756|NCT02529566|"     Investigate the potential of tissue grafting that includes human mesenchymal stem cells in     the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo     and at the time of surgical reconstruction. Our hypothesis proposes that stabilization will     help restore normal structure and function in the degenerative lumbar spine may decrease     chronic low back pain associated with the biomechanical demise of the degenerative disk or     facet and may improve the natural history of adjacent segment disease found after spinal     surgery.   "
57757|NCT02529553|"     The main purpose of this study is to evaluate the safety of the study drug known as LY3076226     in participants with advanced or metastatic cancer.   "
57758|NCT02529540|"     Two-month randomized trial comparing three groups.   "
57760|NCT02529514|"     Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac     surgery.   "
57761|NCT02529501|"     The purpose of this study is to describe, in real-life conditions, the factors influencing     the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient     surgery.   "
57762|NCT02529488|"     The purpose of this study is to investigate visual outcomes and assess safety at 12 months     (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting     IOL.   "
57763|NCT02529475|"     -  This prospective study aims to better characterize inner ear's perilymphatic structures          with Magnetic Resonance Imaging using contrast media and delayed injection in healthy          subjects        -  MR Perfusion Imaging will be assess in both cochlea as well        -  Primary auditory brain pathways will be evaluated through MR diffusion imaging   "
57766|NCT02529436|"     Near 40% of French people aged 65 years and over and suffering from Alzheimer disease and     associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without     ADAD. If depression and anxiety disorders are comorbidities frequently associated with     dementia, such level of AD exposure suggests an overuse of AD in this population.      Hypothesis: Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse     associated with off label prescriptions (no validated indication and excess in prescription     duration) Main objective: to assess the prevalence of AD overuse associated with off label     prescriptions (no validated indication and excess in prescription duration) in patients aged     70 years and over with ADAD.      Secondary objectives:        1. To assess the prevalence of AD prescribed for a non validated indication        2. To assess the prevalence of AD prescribed with excess in prescription duration        3. To assess the prevalence of psychotropic coprescription and notably the prevalence of          the neurologic iatrogenic alerts as defined by the French National Authority for Health        4. To assess factors associated to AD overuse Method: A transversal monocentric study in          the geriatric day Bretonneau unit will be performed. Study will be proposed to all          eligible patients (with non-opposition of the patient or of his legal representative to          the collection of his personal data). Included people will have no supplementary          clinical or complementary investigations. The geriatrician in charge will have to          systematically collect the indication and the history of the AD treatment. At the end of          the evaluation performed in the geriatric day unit, the geriatrician will have to          conclude to the AD overuse or not associated with off label prescription. Doubtful case          will be examined by a validation committee.      Eligibility criteria: Patient consulting in geriatric day hospital with age ≥70 years and     dementia according to DSMIV criteria, whatever its level and antidepressant prescription.      Sample size Considering that 40% of people suffering from ADAD are prescribed antidepressant     (data from French Health Insurance), the number of eligible patients consulting in the     geriatric day swill be 65 in 6 months. If 10% of them are opposed to the collection of their     personal data and if the overuse of AD is near 50%, precision of the result will be 12.8%     (95%CI bilateral).      Duration of inclusion: 6 months Duration of patient's participation: one day   "
57767|NCT02529423|"     The study examines the feasibility and effectiveness of two different nutritional strategies     (multi‐nutrient supplement and food‐related behavioural change) to prevent depression in     high‐risk overweight European Union citizens. Interventions will last 12 months. Design is a     two‐by‐two factorial randomized controlled prevention trial with four intervention groups:        1. Control group (daily placebo supplements)        2. Multi-nutrient supplementation group (daily multi-nutrient supplement)        3. Food-related behavioural change group (food-related behavioural activation focusing on          improving overall diet + placebo supplements)        4. Multi-nutrient supplementation + food-related behavioural activation group (daily          multi-nutrient supplement + food-related behavioural activation focusing on improving          overall diet).      Follow‐up assessment will be conducted at 3, 6, and 12 months for primary and secondary     endpoints, and during intervention for compliance, adverse events and mediating     variables.Data will first be analyzed according to the intention‐to‐treat principle, using     (mixed model) analysis of covariance with primary and secondary endpoints, testing for the     effects of the two nutritional strategies separately as well as combined.   "
57768|NCT02529410|"     100 pt multicentre study 50 pts randomised to triventricular pacemaker, 50 to biventricular     pacemaker Feasibility study with 6 month outcome data   "
57769|NCT02529397|"     This study will examine the effects of providing subjects who have attention deficits, with     or without a formal diagnosis of attention deficit hyperactivity disorder (ADHD), with     Working Memory computerized training and explore whether this training is a feasible way to     help them better engage in a weight loss treatment program, thereby enhancing weight loss     results. Half of the participants will receive five weeks of online adaptive WM training     concurrently while attending an in-person 24-week behavioral weight management program and     half will receive five weeks of a non-adaptive form of cognitive training concurrently while     attending a 24-week behavioral weight management program in person.   "
57772|NCT02529358|"     The study presents findings from a randomized clinical trial evaluating the effects of text     messages encouraging short emotion regulation exercises on the course of psychopathological     symptoms after inpatient treatment for depression. In this context, the study also compares     the effectiveness of standardized versus personalized text messages.   "
57775|NCT02529319|"     This proposal is aiming at modifying and improving persistent AF management guidelines by     evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related     effect on procedural outcome.      OBJECTIVES:      Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an     ablation procedure in treating persistent AF. Results from the DECAAF study show that one of     the most important predictors of ablation outcome was the degree of ablation of the fibrotic     tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better     the outcome. These results were the impetus for the primary outcome of DECAAF II. Patients     will be randomized to receive conventional pulmonary vein isolation (PVI) ablation or PVI +     fibrosis-guided ablation. The investigators will follow patients longitudinally to assess the     primary outcome identified as recurrence of persistent atrial arrhythmias (AA) (atrial     fibrillation, atrial flutter or atrial tachycardia as defined by recent guidelines [2]). The     investigators hypothesize that patients receiving fibrosis-guided ablation in addition to     conventional PVI ablation will have fewer AA recurrences than those who receive PVI ablation     alone.      The investigators will also examine the efficacy of the fibrosis-guided ablation intervention     on a number of secondary or exploratory outcomes including the individual components of the     primary outcome (atrial fibrillation, atrial flutter and atrial tachycardia), symptomatic     atrial arrhythmia, AF cycle length/regularity/termination, cardiovascular (CV)-related     hospitalization, CV-related mortality, quality of life measurements (University of Toronto     Atrial Fibrillation Severity Scale (AFSS), and AF burden.      The safety of the two interventions will be evaluated by evaluating peri-procedural     complications including stroke, peripheral vascular stenosis, bleeding, esophageal injury,     cardiac perforation, heart failure, and death.   "
58002|NCT02526368|"     This is a pilot study evaluating pre-surgical patients with histologically confirmed     localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection     and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical     prostatectomy.   "
58218|NCT02523547|"     Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.   "
57777|NCT02529293|"     This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the     feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone     insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.      Each subject will be randomly allocated to a sequence of four treatments, i.e. two single     doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of     BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.   "
57778|NCT02529280|"     Increasing Access of Latinas into Breast Cancer Clinical Trials aims to develop and pilot     test a multi-communications approach - using a culturally relevant computer video, a tailored     booklet and a patient navigator (PN) - to empower Latinas to make informed decisions about     breast cancer clinical trials (BCCTs). Latinos represent 15% of the U.S. population but only     5.6% of participants in National Cancer Institute (NCI) treatment clinical trials, resulting     in disparities in cancer outcomes and jeopardizing the generalizability of trial findings. In     response, this study will develop and evaluate communication and health-system-change     strategies to facilitate Latinas' access to BCCTs at the Cancer Therapy and Research Center     at The University of Texas Health Science Center at San Antonio (CTRC-UTHSCSA). The     CTRC-UTHSCSA, an NCI-designated Cancer Center located in South Texas, serves a culturally and     ethnically diverse population that historically has low participation in clinical trials,     especially among those with breast cancer, the No. 1 cancer killer of Latinas.   "
57779|NCT02529267|"     Intimate partner violence (IPV), also known as domestic abuse, is a leading cause of     non-fatal injury in women worldwide. 1 in 6 women attending surgical fracture clinics have a     history of IPV in the past year. Given the high prevalence and costs associated with IPV,     there is a need to identify health outcomes associated with IPV, the incidence of new and     worsening cases of IPV, and resource use among IPV victims. This prospective cohort study of     women with fractures and dislocations will assess differences in injury-related outcomes     (time to fracture healing, injury-related complications, and return to pre-injury function)     between abused and non-abused women. This study will also determine whether a musculoskeletal     injury can lead to new or worsening abuse by an intimate partner and how patterns of IPV     change over time following musculoskeletal injuries.Finally, the proposed study will also     inform the feasibility of a larger multinational cohort study.   "
57780|NCT02529254|"     The purpose of this study is to determine if video coaching is an efficient way of teaching     surgical skills outside of the operating room for surgical residents.   "
57781|NCT02529241|"     To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a     single oral dose in healthy male subjects.      To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male     subjects.   "
57782|NCT02529228|"     This study examines the effect of meal frequency and meal composition on risk factors of     cardiometabolic disease.   "
57783|NCT02529215|"     Communication and teamwork failures are the leading causes of errors in healthcare settings.     In situ mock code simulations are a potential means to train team-based skills using     simulation within real clinical care environments where errors occur; however, debriefing     discussions often focus on gaps in learners' clinical skills as opposed to team functioning.     This study aims to determine whether learners who are pre-trained using just-in-time     simulation regarding CPR quality and medication administration will exhibit improved     performance with respect to these skills during in situ mock codes as well as improved team     functioning.   "
57784|NCT02529202|"     The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns     ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic     encephalopathy.   "
57785|NCT02529189|"     The mainstay treatment for reducing the symptoms of angina and long-term risk of heart     attacks in patients with heart disease is stent implantation in the diseased coronary artery.     Whilst this procedure has revolutionised treatment the incidence of secondary events remains     a concern. These repeat events are due in part to continued enhanced platelet reactivity,     endothelial dysfunction and a phenomenon called 'restenosis' i.e. the stent becomes blocked     ultimately requiring another expensive and risky procedure. In this study it will be     determined whether a once daily inorganic nitrate administration might favourably modulate     platelet reactivity and endothelial function leading to a decrease in restenosis.   "
57786|NCT02529176|"     This is a randomized trial of a best-practice alert delivered via the electronic medical     record (Apex) to physicians on the Medicine service at UCSF Medical Center over a six month     period. The alert notifies physicians that their order for continuous cardiac monitoring     (telemetry) for a given patient has exceeded the duration recommended by national guidelines     and offers them the opportunity to discontinue monitoring if they feel it is clinically     appropriate. Physicians will be randomized to either receive the BPA or not, with the     anticipation that physicians in the intervention arm will discontinue unnecessary telemetry.   "
57787|NCT02529163|"     As of late Integrated Care Pathways (ICPs) have been shown to improve quality of care in the     medical field with special attention given to mental health in particular. One aspect of     metal health that has not seen the incorporation of ICPs is in the area of schizophrenia.     Late life Schizophrenia (LLS) is defined as suffering from schizophrenia and being 50 years     of age or older. The LLS-ICP study will look at the efficacy of an ICP in late life     schizophrenia versus treatment as usual (TAU). Participants with LLS and having psychotic     symptoms above a predefined threshold will be randomly assigned to a TAU group or an ICP     group. The primary outcome measure will be reduction in symptom severity as measured by     clinical global impression severity scale (CGI-S) and brief psychiatric rating scale (BPRS).     If successful, this study will provide strong evidence to implement LLS-ICP across different     inpatient and outpatient settings.   "
57843|NCT02528435|"     Methotrexate is a cornerstone in the treatment of childhood leukemia. When given in high-dose     as part of the initial phase of treatment, gastrointestinal toxicity is a known problem.     However when children reach maintenance treatment with low-dose methotrexate this is not     described as a significant challenge. Children with juvenile idiopathic arthritis are another     patient group receiving low-dose methotrexate. Among these patients gastrointestinal     intolerance is such a significant problem that treatment may be ceased. The aim of this     project is to create a greater understanding of gastrointestinal intolerance associated to     low-dose methotrexate treatment by investigating the differences between these two patient     groups, investigating genetic and psychological factors.   "
57788|NCT02529150|"     One in four deaths in the United States is due to cancer, and one in three women will develop     cancer in her lifetime. Despite improvements in survival among other forms of cancer, ovarian     cancer prognosis remains poor. Eighty percent of women with ovarian cancer will present with     advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2 Among patients     with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are high.4 Therefore,     interventions focused on preventing recurrence or slowing progression of EOC is a critical     problem in the field. The investigators have submitted an R21 to NCI for a dose response     exercise intervention trial to examine the dose response effects of aerobic exercise on     biomarkers relevant to ovarian cancer progression and recurrence. The reviewers would like     assurance that the investigators can recruit ovarian cancer patients into an exercise study     and that these women will do the exercise protocol we plan to prescribe in our high dose of     exercise.   "
57789|NCT02529137|"     The primary objective of this study is to show safety and effectiveness of the PDx for In     Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital     images of surgical pathology slides.   "
57790|NCT02529124|"     The focus is healthy ageing, i.e. delaying the deterioration in health status in older     adults. Loss of lean tissue (skeletal muscle) mass, a process termed sarcopenia, or bone     tissue mass, a process called osteopenia, is a consequence of aging per se, modified by     nutrition and lifestyle behaviour.      The aim is to conduct a study of body composition, physical activity, muscle function and     ability to undertake activities of daily living in older Irish men and women and to     investigate the effect of a six month period of nutrient support, or nutrient plus physical     activity on lean tissue mass and function and bone mass in men and women aged 50 to 70 years.   "
57791|NCT02529111|"     The interventional catheterization allows the percutaneous treatment of congenital heart     diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with     stochastic side effects worrying at the child's. The software Echonavigator allows to merge     the ultrasound image and fluoroscopic. This innovative software facilitates the procedures     and reduce the irradiation time in some adult procedures.      The aim of this study was to validate the image fusion in children.   "
57792|NCT02529098|"     This study will highlight differences in cortical activation between asymptomatic and     symptomatic patients.   "
57793|NCT02529085|"     The present project aims to determine the underlying mechanisms for the switch from failure     to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS. The primary     objective is to describe the evolution of circulating hormones involved in feeding and     appetite regulation during the 4 first years of life. The secondary objective is to make this     blood bank available for other research projects and particularly the investigation of     hormones involved in hypogonadism.      Over the last ten years, the age at diagnosis in PWS has fallen significantly and the     majority of cases is now diagnosed during the 1st trimester of life giving the possibility to     collect precise clinical data and serum samples at early stages. The investigators of the     project are involved in the care of patients with PWS and have a devoted clinic and an     organized network in their country through clinical networks or patient associations.   "
57794|NCT02529072|"     Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will     receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab     alone and with DC vaccine therapy until surgical resection. During surgical resection blood     and tumor samples will be assessed and compared. Following surgery, both groups will continue     to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.   "
57795|NCT02529059|"     This study aims to investigate whether substitution of Efavirenz (EFV) as the     Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) fixed-dose combination (FDC) Atripla, with     Rilpivirine as the tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) fixed-dose combination     (FDC) Eviplera, leads to resolution of covert Central Nervous System (CNS) toxicity     associated with EFV, continued virological suppression and immunological reconstitution and     whether this is associated with an improvement in quality of life, sleep, anxiety/depression     and neurocognitive function; the impact of switch on adherence will also be investigated.   "
57796|NCT02529046|"     In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation     associated with aerobic exercise on body fat and lipid profile in obese women.   "
57799|NCT02529007|"     The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a     colonoscope improves the numbers of polyps detected during bowel cancer screening     colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy     with the cap attached.   "
60339|NCT02495922|"     Trial in patients with newly diagnosed myeloma to evaluate the effect of elotuzumab in     induction and consolidation therapy with bortezomib/lenalidomide/dexamethasone and in     lenalidomide maintenance treatment   "
57801|NCT02528981|"     Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in     Canada. It may be passed from a study participant colonized in the genital tract by GBS to     their baby during vaginal birth. While approximately 10 to 30% of pregnant people harbour GBS     in the vagina or rectum, the incidence of neonatal GBS disease is 1 to 2 infants per 1000     births. The use of intrapartum antibiotics to treat colonized individuals with or without     risk factors has led to a 70% decline in the incidence of early-onset GBS sepsis in the past     decade. Despite this impressive decline, antibiotic resistance has become a major public     health concern. Association between intrapartum antibiotic use and ampicillin resistance in     E. coli isolated from neonates has previously been documented. Furthermore, while GBS has     remained sensitive to penicillin, 20% are resistant to erythromycin and clindamycin, which     are alternate drugs for patients allergic to penicillin. Alternative approaches are therefore     needed to reduce the risk of GBS infection.      We therefore propose to study the use of Lactobacillus rhamnosus GR-1 and Lactobacillus     reuteri RC-14 (Lactobacillus fermentum RC-14) in the colonization status of GBS in pregnant     people. Lactobacilli are part of normal gut and vaginal flora and have been widely used as     probiotics to treat various conditions. In particular, these two strains have shown to be     beneficial in the treatment of urinary tract infections and bacterial vaginosis. Our study     design involves recruiting two hundred pregnant people (one hundred in each arm) through     various midwifery practices in the GTA at the end of their first trimester of pregnancy.     These individuals will be randomized to receive probiotics or placebo for twelve weeks of     their pregnancies and will be cultured before delivery to determine their colonization     status. The capsules with probiotics and placebo will be provided free of charge. The study     design was chosen to minimize the cost and clients' visits to the clinic as vaginal/rectal     swabs are routinely offered at 35-37 weeks of gestation.   "
57802|NCT02528968|"     Prospective, interventional study of pharmacokinetic (PK)-focused FVIII dosing discussions     delivered as part of a patient education package.      The study will capture severe haemophilia A patient reported outcome measures before and     after PK-focused dosing discussions, including a standardised patient education package, that     include personalised PK-guided dosing suggestions from a computational predictive device     (myPKFiT®). The pragmatic study design recognises the CE marked myPKFiT® device is being     implemented into routine care nationally and consequently only requires a single additional     clinic visit for the purpose of consenting.   "
57803|NCT02528955|"     In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with     >= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care.     Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis,     lymph node metastasis with extracapsular spread and or R1/2 resection.      Locoregional control rates are over 80% after surgery and radio(chemo)therapy. But many     patients suffer from therapy-related long-term side-effects, like xerostomia, dysphagia,     fibrosis, trismus etc.      The aim of this study is to investigate if depending on primary tumor stage, quality of     resection ( resection margin) and number of lymph node metastasis and performed neck     dissection an adapted de-intensified dose- and target volume concept may be performed without     reducing locoregional-control but with reducing radiotherapy-related side-effects.   "
57804|NCT02528942|"     The proposed study is in the field of thoracic radiation oncology where radiation therapy is     used to treat lung cancer. The primary objective of the early phase clinical trial will be to     evaluate the safety of performing functional avoidance radiation therapy for lung cancer     patients using 4D computed tomography (4DCT) ventilation imaging.   "
57805|NCT02528929|"     To evaluate the effects of a gluten-free diet in irritable bowel syndrome.   "
57806|NCT02528916|"     Nociceptin/Orphanin is a novel opioid peptide system associated with inflammatory response.     Currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of     patients. Nociceptin levels will be measured pre-operatively and post-operatively in plasma     levels of patients receiving primary total knee arthroplasty. Nociceptin levels will also be     measured in synovial fluid levels prior to surgical manipulation.   "
57807|NCT02528903|"     This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study     in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of     MHAB5553A.   "
57808|NCT02528890|"     The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth     Hospital through the years 2006-2013 has been higher compared to the national average. On     reviewing all the cases of infants with early GBS infection, revealed that some of these     infants were born to mothers who are not included in any of the high-risk groups that need to     have prophylactic antibiotic treatment before delivery. Therefore, the question was whether     pregnant Arab women in the North district of Israel have a higher GBS carrier state rate than     the general rate in Israel?   "
57809|NCT02528877|"     This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given     together with tacrolimus and sirolimus in preventing acute graft-versus-host disease during     reduced intensity donor hematopoietic cell transplant in patients with myelofibrosis.     Sometimes transplanted cells from a donor can attack the normal tissue of the transplant     patient called graft-versus-host disease. Ruxolitinib phosphate may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. It may also reduce     graft-versus-host disease by reducing inflammation and immune modulation. Giving ruxolitinib     phosphate together with tacrolimus and sirolimus after transplant may prevent     graft-versus-host disease.   "
57810|NCT02528864|"     The aims of this project are: (1) To establish a research platform in order to integrate     multiparametric imaging and metabolomics data for uterine malignancy. (2) Identify potential     surrogate biomarkers for early diagnosis of endometrial cancer by using multiparametric     magnetic resonance imaging and metabolomics approach. (3) To develop surrogate biomarkers for     uterine malignancy, in detecting tumor involvement of myometrium, cervix, and lymph nodes.     The investigators propose a 3-year research project to prospectively collect data from 150     female patients 20-80 years old, with clinically diagnosed or suspected to have uterine     malignancy. An additional control group comprising 30 patients with normal endometrial tissue     will be enrolled. Robust magnetic resonance (MR) imaging techniques including MR spectroscopy     (MRS), diffusion-weighted imaging and chemical exchange saturation transfer (CEST) imaging     will be applied. Biological samples (tissue, blood, urine) will be analyzed by detailed     metabolomics approach (high-resolution MRS).   "
57864|NCT02528162|"     Prospective observational cohort study of women with gestational diabetes (GDM) based on the     'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is     to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction of     women with GDM about the education they receive (given in group or individually). Normal     routine care is followed and evaluated.   "
58796|NCT02515955|"     The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of     JNJ-54175446 after multiple consecutive dose administrations   "
57811|NCT02528851|"     The aim of this study is to compare the cardiovascular and respiratory effects of higher     versus equivalent CPAP pressures post-extubation from high endotracheal airway pressures     (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled     cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure     (MAP) [if on high frequency ventilation] or positive end-expiratory pressure (PEEP) [if on     conventional ventilation] at time of extubation. Participants will be randomized to higher     CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or equivalent CPAP group     (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We     hypothesize that higher CPAP levels, when compared to equivalent CPAP levels, do not     adversely impact the cardiorespiratory status when a patient is extubated from high EAP.   "
57812|NCT02528838|"     The study is designed as a prospective, non-interventional, observational single arm study.     Hundred-fifty patients over 18 with stable disease or at least partial response while on     treatment with lenalidomide will be recruited from approximately 20 haematology/oncology     sites in the Netherlands. Recruitment will continue until 150 patients have started the     study. When this target is reached, all patients on lenalidomide will continue to be followed     until the last patient has been followed for 36 months.   "
57813|NCT02528825|"     Smooth emergence is important for patient safety and satisfaction. Coughing during emergence     is associated with detrimental effects like laryngospasm, sore throat, hoarseness, negative     pressure pulmonary edema and bleeding at surgical site 1. Especially sore throat and     hoarseness are most common complications after extubation 2,3 and closely related to patient     satisfaction 4. Using double lumen tube (DLT) increase the incidence of hoarseness and airway     injury than using single lumen tube for it has large size5,6. Various technique and drugs     have been proposed for reducing coughing during extubation including smooth emergence 1,7-11     and this is closely correlate with reducing sore throat and hoarseness 12. One of the     proposed technique, the use of short acting opioids are prefered13-15 because it can be     maintained during emergence with less respiratory depression. Remifentanil is a potent short     acting opioid and several studies choose remifentanil combined with other anesthetic agents     1,15,16. There is a study about the EC50 and EC95 of remifentanil in effect site Target     controlled infusion(TCI) for preventing cough during emergence after thyroidectomy with     propofol-remifentanil anesthesia 15 but no study about the proper dose of remifentanil for     smooth DLT extubation.      The purpose of this study was to evaluate the EC50 and EC95 of remifentanil in effect-site     TCI for preventing cough during extubation of DLT in total TIVA with propofol and     remifentanil.   "
57814|NCT02528812|"     In a randomized control trial and single blinded study, tender spots were identified in 150     participants` plantar flexor muscles (gastrocnemius or soleus). Then participants were     randomly assigned to one of five intervention groups (n = 30): 1) heavy rolling massage on     the calf that exhibited the higher tenderness (Ipsi-R), 2) heavy rolling massage on the     contralateral calf (Contra-R), 3) light stroking of the skin with roller massager on the calf     that exhibited the higher tenderness (Sham), 4) manual massage on the calf that exhibited the     higher tenderness (Ipsi-M) and 5) no intervention (Control). Pain pressure threshold (PPT)     was measured at 30 seconds and up to 15 minutes post-intervention via a pressure algometer.   "
57815|NCT02528799|"     A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human     Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.   "
57816|NCT02528786|"     The purpose of this study is to obtain blood samples from up to 14 subjects who previously     received namilumab in the previous study M1-1188-002-EM (PRIORA, [NCT01317797]) to correlate     genetic markers with clinical outcomes.   "
57817|NCT02528773|"     The investigators are conducting a study to learn more about the spread of HIV infection     within different geographic regions and populations in San Diego County, with the goal of     demonstrating that early use of HIV treatment can reduce the number of new infections in our     community. At the study visits, participants will be examined by the study staff and asked to     donate some blood. Participants will also be asked several questions about themselves, their     background, behaviors, health, and the general geographic area in which they live. By     collecting information about antiretroviral treatment choices that are made by study     participants, the investigators will be better able to measure how effectively HIV treatment     can interrupt (i.e., block) the spread of HIV. All of the information gathered at the study     visits will be de-identified and analyzed. Study staff will use the information to better     understand in which groups of people, and in what areas of San Diego, HIV is spreading most     quickly. This information will be used to determine how well Antiretroviral Therapy (HIV     treatment) by certain individuals can control the spread of HIV within the population.   "
57818|NCT02528760|"     1. All patients with chronic liver disease admitted in ICU (Intensive Care Unit) to be          screened.        2. Patients fulfilling criteria for feed intolerance to be included in the study.        3. Patients to undergo routine biochemical and hematological testing including CBC, KFT,          LFT, PT/INR, electrolytes baseline and daily along with ABG (Arterial Blood gas)          analysis.        4. Patients with ascites to be tested for presence or absence of SBP (Spontaneous Bacterial          Peritonitis).        5. Cultures to be sent as based on clinical parameter of the patient.        6. All correctable causes for intra abdominal hypertension to be corrected including          electrolyte imbalance, grade III ascites, intra abdominal infection.        7. Symptoms- Absent bowel sounds (BS)= no BS detected by auscultation.          Vomiting/regurgitation= any visible regurgitation of gastric contents; Diarrhoea= liquid          stool > or =3 times/day; Bowel distension= suspected clinically and radiologically          confirmed; Large gastric residual volume (GRV) of >or =500 ml/24 h on a single day or >          200ml at any time of the day.        8. Per abdomen findings to be checked daily including presence of bowel sounds, tenderness,          development of abdominal distension, abdominal girth monitoring and abdominal pressure          monitoring.        9. Patients who develop feed intolerance will be included.       10. Feed intolerance to be defined as per study definition (3 out of 5 symptoms).       11. Measurement of GRV (Gastric residual volume) to be done at 4 hourly interval.       12. Methods for measuring GRV by either gravity drainage by connecting a gastric tube to a          drainage bag for 10min or by manual aspiration of content using a 50ml syringe.       13. Once feed intolerance develop than every 6 hourly intra abdominal pressure monitoring          and abdominal girth monitoring to be done (24)       14. Intra bladder pressure to be measured using Foleys manometer technique (25).       15. Pressure measured in cm of water to be converted into mm of Hg.       16. X ray abdomen supine to look for bowel distension, defined as more than 3 cm for small          bowel and more than 5 cm in large bowel.       17. Development of intra abdominal hypertension based on intra abdominal pressure.       18. Patient to be stratified according to the grade of intra-abdominal hypertension.       19. After correction of all correctable causes, if feed intolerance persists, then patient          to be randomized by block randomization method into 3 arms, metaclopromide group,          erythromycin group or placebo group.       20. Daily assessment of bowel sounds, abdominal pressure, abdominal girth every 6 hourly and          gastric residual volume to be noted every 4 hourly.       21. Response of therapy to be assessed at 24 hours in each arm.       22. Response to be assessed by resolution of feed intolerance or initiation of entral          nutrition.       23. Metoclopromide to be given 10mg iv 8 hourly.       24. Erythromycin to be given 70mg iv 12 hourly (26).       25. Placebo arm to receive normal saline in 10ml syring twice daily.       26. After 24 hours of treatment if symptoms do not resolve than rescue treatment will be          given to each arm which may include continuation of prokinetics, add on prokinetic,          flatus tube insertion for bowel decompression, upgradation of antibiotics or search for          any other cause, as per the patient response.       27. Therapy to continue for a total duration of 72 hours.       28. If there is no response at 72 hours, than study stops.       29. If patient responds to given treatment, study to continue for a total duration of 7          days.       30. Assessment to continue in each arm for a maximum period of 7 days.   "
57819|NCT02528747|"     This observational, multicenter survey is designed to assess the efficacy of oral ibandronate     in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in     clinical practice will be collected from Hungarian patients.   "
57820|NCT02528734|"     Monocentric observational study of needle exsufflation for pneumothorax in the ICU.   "
57821|NCT02528721|"     The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode     BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis     and post treatment monitoring of H.pylori infection in adult patients and its results will be     compared to biopsy results.   "
57822|NCT02528708|"     In this prospective, single-center, randomized, placebo-controlled, double-blind clinical     trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate     following both vaginal delivery and cesarean section complicated by an estimated blood loss     (EBL) >1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume     replacement, uterine massage, and uterotonic agents).   "
57894|NCT02527772|"     The purpose of this study is to determine that Liposomal Doxorubicin(LD) plus     Gemcitabine(GEM) is superior to Oxaliplatin（OXA） Plus Fluorouracil/Leucovorin(FOLFOX4) in     prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.   "
58040|NCT02525874|"     The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset     counts during the first year of treatment in subjects with relapsing-remitting multiple     sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute     lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.   "
57823|NCT02528695|"     The metabolic function of different white adipose tissue depots in the body and its role in     the development of type 2 diabetes (T2D) remains unclear. Several studies have used fluor-18     fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) to     image the metabolic activity of different adipose tissues in lean and obese healthy subjects     and in patients with T2D with or without euglycaemic hyperinsulinemic clamping, describing     differences in metabolic activity of visceral adipose tissue (VAT), subcutaneous adipose     tissue (SAT) and gluteal-femoral adipose tissue (GFAT). Recently, FDG PET/CT showed high     glucose uptake in VAT and SAT under unintentional hypoglycaemic conditions in a non-diabetic     patient. Evaluation of potential differences in FDG uptake in white adipose tissue between     healthy volunteers and T2D patients and between VAT, SAT and GFAT in these subjects under     hyperinsulinemic hypoglycaemic conditions would be of great value in further exploring the     pathogenesis of insulin resistance in T2D.   "
57824|NCT02528682|"     Allogeneic stem cell transplantation (allo-SCT) is a potent treatment, and sometimes the only     curative treatment for aggressive hematological malignancies. The therapeutic efficacy is     attributed to the graft-versus-tumor (GVT) response, during which donor-derived CD8+ T cells     become activated by recipient minor histocompatibility antigens (MiHA) presented on dendritic     cells (DC). Consequently, these alloreactive donor T cells clonally expand, acquire effector     functions and kill MiHA-positive malignant cells. However, in a substantial number of     patients persistence and recurrence of malignant disease is observed, indicating that     insufficient GVT immunity is induced. This is reflected by our observation that not all     patients develop a productive CD8+ T cell response towards MiHA mismatched between the     recipient and donor. We found that the PD-1/PD-L1 co-inhibitory pathway is involved in     dampening MiHA-specific CD8+ T cell expansion and function post-transplantation. Therefore, a     promising strategy to induce or boost GVT immune responses is pre-emptive or therapeutic     vaccination with ex vivo-generated donor DCs loaded with MiHA that are exclusively expressed     by recipient hematopoietic cells and their malignant counterparts. In contrast to pre-emptive     donor lymphocyte infusion (DLI) with polyclonal donor T cells, this MiHA-DC vaccination     approach has less risk of inducing graft-versus-host disease (GVHD) and the potency to induce     more efficient GVT-associated T cell immunity. In addition, the potency of this DC vaccine     will be further enhanced by interference with the PD-1/PD-L1 co-inhibitory pathway, using     siRNA mediated PD-L1/PD-L2 silencing.   "
57825|NCT02528669|"     The purpose of this study is to create a platform that accurately measures and reports     patient physical activity before a procedure, during the hospital stay, and after discharge     from the hospital.   "
57826|NCT02528656|"     The physiological assessment in non-operative treatment on chest wall deformities, are still     unclear today. These functional benefits outweigh the aesthetic benefits associated with     anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic,     have never been evaluated.      Assessment of Effects on parasympathetic activity of the autonomic nervous system, global     health criterion measured by noninvasive methods.      Anatomic evaluation, between the initial and final assessment by objective measures 1) of the     chest wall by MRI, and 2) of the heart by echocardiography.      Noninvasive physiological assessment at rest and during exercise in respiratory function     exploration flows and volumes, cardiac function by flow measurement, and overall metabolic     function test effort (VO2max). Subjective assessment of functional gain between the initial     and final balance sheet, based on EVA scales, valued by patients, parents and doctors.   "
57827|NCT02528643|"     The purpose of the study is to evaluate the efficacy of enzalutamide in subjects with     advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS).      This study will also evaluate the safety of enzalutamide; pharmacokinetics of enzalutamide     and the active metabolite N-desmethyl and Progression Free Survival (PFS) of enzalutamide as     compared to placebo in subjects with advanced HCC.   "
57828|NCT02528630|"     Background: Hand osteoarthritis (OA) is highly prevalent, affecting 55-70% of the population     over 55 years with an age-related progressive increase. The OA of interphalangeal (IF) and     carpometacarpal joints may have varying degrees of deformity associated with pain, decreased     of grip and pinch strength, decreased range of motion and functional impairment. Systematic     reviews and meta-analyzes have shown the beneficial effect of exercise for lower limb OA,     however for hand OA exercise is still used based on recommendations based on clinical     experience and low quality studies, not allowing a conclusion about the effects of exercise     in pain, function and strength in hand OA patients.      Objective: assess the effectiveness of progressive resistance strength training program on     pain, function and strength in hand OA patients.      Methods: diagnostic of hand OA according to American College of Rheumatology of at least     1year, age over 50 years, both genders, pain in IF joints between 3-8 cm on a 10-cm numerical     pain scale (NPS). Sixty patients who meet the eligibility criteria were randomized into     exercise group (EG) and control group (CG). Both groups performed a session regarding joint     protection and energy conservation before randomization. The EG performed a progressive     resistance strength training program for intrinsic muscles of the hand for 12 weeks. The     outcome measures were NPS; Australian/Canadian (AUSCAN) Hand Osteoarthritis Index and Cochin     Hand Functional Scale for hand function; grip and pinch strengthening using the Hydraulic     Hand Dynamometer and a pinch gauge dynamometer and satisfaction with the treatment using a     Likert scale. A blinded evaluator performed the evaluations at baseline, 6 and 12 weeks after     treatment baseline.   "
57829|NCT02528617|"     The purpose of this trial is to study the effect of Velaglucerase Alfa on skeletal bone     development of children with Type 1 or Type 3 Gaucher Disease. In addition, the natural     history and neurological status of children with Type 3 Gaucher Disease will be studied.   "
57830|NCT02528604|"     Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker     implantation with AV node ablation for patients over 65 years of age with persistent Atrial     Fibrillation.   "
57917|NCT02527473|"     In an attempt to enhance OHCA survival by increasing bystander CPR rate, this study will     assess the effectiveness of the new basic life support with dispatch assistance (DA-BLS)     education program through a simulation experiment.      This study aims to determine whether the new DA-BLS program for possible home bystanders is     associated with improved CPR quality. We expect home bystanders who were trained with new     DA-BLS education program to show better compliance with CPR instructions given by dispatcher     via telephone along with improved CPR quality.   "
57831|NCT02528591|"     The renal transplant patient is at high cardiovascular risk compared to the general     population. The cardiovascular mortality represents one of the most important causes of late     graft loss. Cardiovascular risk prediction tools applied to the general population, however,     are caught failing on the population of kidney transplant and tend to underestimate the     actual risk.      Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is     directly related to the target organ (heart, kidney, brain). Central blood pressure could be     a cardiovascular risk factor more robust and powerful than brachial blood pressure.      Central blood pressure may in part explain the increased risk of cardiovascular disease in     the population of kidney transplant patients. A cohort of 250 kidney transplant patients will     be constituted with a measure of concomitant central hemodynamic monitoring to the annual     review will be conducted. The main objective of this study is to describe the central blood     pressure measured by oscillometric method in renal transplanted population.   "
57832|NCT02528578|"     The objective of the study is to evaluate in healthy volunteers, the influence of empathy on     pain perception.      It is widely accepted in the clinical management that the feeling of listening to the     patients' pain would have a favorable influence on the pain, and conversely, the lack of     listening would be aggravating.      In this study, the volunteer will receive painful thermal stimuli in empathetic context (l,     empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or     minimize the suffering of the voluntary and the other or the contrary, the subject will     receive empathy.      The first part of the project is to verify that the pain is influenced by the empathetic     context. The second part will be conducted functional MRI, which should isolate the brain     regions affected by other people's empathy for pain.   "
57833|NCT02528565|"     The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in     patients after failed RYGB.   "
57834|NCT02528552|"     This is a prospective, randomized double-blind, multi-center study to evaluate the efficacy     of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to     SHAM for promoting hair growth in males diagnosed with androgenetic alopecia, and a usability     study to assess subject ability to self-assess hair loss and understanding use of the device.   "
57835|NCT02528539|"     Introduction: Breast cancer women who are treated with axillary node dissection are at     increased risk for lymphedema - the lifetime risk in these women is estimated at 15-50% and     the risk can significantly increase with chemotherapy and radiation therapy      Objectives:        1. To evaluate the feasibility and effectiveness of implementing the integrative therapy          program (ITP) intervention. ITP consists of self-management education in conjunction          with acupuncture.        2. To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain,          and early detection and management of lymphedema.      Design: the exploratory study aims to evaluate the feasibility and benefits of the     integrative therapy program (ITP) intervention post-operatively for 18 months.      Subjects: Women with breast cancer treated with axillary node dissection with normal baseline     pre-operative bioimpedance (L-dex U400) score.      Sample size: 30 subjects   "
57836|NCT02528526|"     The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe     and tolerated in patients with primary and secondary hepato-pancreato-biliary and     gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At     level of MTD, additional patients will be included aimed for assessing the efficacy profile     in these neoplasia entities.   "
57837|NCT02528513|"     The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or     sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically     ill, mechanically ventilated patients.   "
57838|NCT02528500|"     This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch     Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral     Branch Vessels.   "
57839|NCT02528487|"     The present study aims to assess the prevalence and impact of comorbid psychiatric disorders     among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary     rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on exercise     tolerance and physical activity post-PR and HRQoL, as well as to determine the processes by     which these psychiatric disorders may impact on these patient behaviours.   "
57840|NCT02528474|"     Drug-coated balloon technology (DCB) has recently attracted considerable interest as a     promising alternative treatment option, particularly in the setting of in-stent restenosis     (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents     (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be     compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.   "
57841|NCT02528461|"     The purpose of the study is to investigate how the liver is affected with regard to     inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.      In order to examine how the liver heals, we want to use blood samples to check for the     occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent     fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of     ultrasound examination) and also preferably with extraction of a small tissue sample. We want     to examine how the liver function as inflammation and scar tissue decrease, especially     concerning the liver's ability to produce proteins. Furthermore, we want to examine with a     gastroscopy, if the circulation of blood in the liver is improved after successful treatment     with the expected result that potential varicose veins in the esophagus vanish.   "
57842|NCT02528448|"     The purpose of this study is to determine if chloride is nephrotoxic using 0,9% saline versus     Plasma-Lytein in patients having primary hip replacement surgery. The outcome is found     measuring bio markers, vasoactive hormones and salt regulation. And to measure syndecan as a     marker for glycocalyx degradation.   "
57930|NCT02527304|"     This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT)     in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a     specialized radiation therapy that delivers a single, high dose of radiation directly to the     tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT     uses information gathered during treatment to inform, guide, and alter future radiation     treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive     staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.   "
57844|NCT02528422|"     Ghrelin (growth hormone release inducer) is produced in the stomach. The active form of     Ghrelin is Acyl-Ghrelin. Acyl-Ghrelin stimulates the Ghrelin receptors. Ghrelin receptors are     detected in the distal tubules in mice and animal studies have shown that Ghrelin increases     the absorption of sodium in the renal tubules. Ghrelin infusion directly into the renal     artery of rats increased sodium reabsorption in the distal nephron, presumably via the     epithelial sodium channels (ENaC).      The purpose of the study is to measure the acyl-ghrelin induced effects on GFR, tubular     transport of sodium and water in different nephron segments and central and peripheral blood     pressure in a randomized, cross-over, single-blind, placebo-controlled dose-response study.   "
57845|NCT02528409|"     The aim of the present study is to examine the efficacy and safety of vortioxetine vs placebo     in adults with moderate to severe Binge eating disorder, as indicated by at least 3 binge     eating days per week for the 2 weeks before the baseline visit.   "
57846|NCT02528396|"     This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an     individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes     mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro     compared to Humalog®. The assessments will be conducted before and after a period of multiple     daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3     and on day 14 of each period. Furthermore the study aims at investigating Post-prandial     glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various     injection meal intervals (-15min, 0 minutes, +15 minutes).      Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin     lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of     injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be     performed during the 14 day treatment periods.   "
57847|NCT02528383|"     Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as     vaginal dryness and urinary discomfort. The purpose of this research study is to see the     benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal     symptoms and health. The investigators also want to monitor whether the bones might be     impacted by estrogen or its absence. If there is an effect on bones, it means that some     estrogen may be absorbed from the tablet to affect other places in the body. The     investigators are hoping to prove this is not the case. The investigators will also be     measuring the quality of life of women participating in the study.   "
57848|NCT02528370|"     Observational non-randomized study with an intervention cohort from Hospital     Galdakao-Usansolo with 119 patients and a control cohort from Hospital Cruces with 78     patients. The inclusion criteria were: being hospital admitted at least twice in the previous     year or at least three times in the 2 previous years. The cohorts were follow-up for 2 years.     Several clinical measurements like pulmonary function, exercise capacity, health related     quality of life, limitation in daily life activities and anxiety and depression were recorded     in both cohorts. Telemonitoring and an organized education program were only and exclusively     applied in the intervention cohort.   "
57849|NCT02528357|"     This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed     to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and     preliminary clinical activity of GSK3174998 administered intravenously to subjects with     selected advanced or recurrent solid tumors.      This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy     (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with     additional therapies.      The study will be conducted in 2 parts, each part consisting of a dose-escalation phase     followed by a cohort expansion phase. Part 1 will evaluate GSK3174998 monotherapy, while Part     2 will evaluate GSK3174998 in combination with pembrolizumab.      GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of     GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic     activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be     evaluated with fixed doses of pembrolizumab.      The study will enroll up to approximately 264 subjects with different tumor types     (approximately 144 subjects in Parts 1A and 2A [dose escalation]; approximately 120 subjects     in Parts 1B and 2B [cohort expansion]). The maximum duration of treatment with GSK3174998     plus or minus pembrolizumab will be 2 years or 35 cycles, whichever comes first. The     follow-up period for safety assessments will be a minimum of 3 months from the date of the     last dose. The post-treatment follow-up period includes disease assessments every 12 weeks.   "
57850|NCT02528344|"     The overall objective is to determine whether High Intensity Interval Training (HIIT) has     potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients. By     reducing inflammation and modifying immune function HIIT may offer a substantial paradigm     shift in RA care, especially in older persons with RA who experience aging     related-immunesenescence, increased systemic inflammation and greater physical inactivity     than young persons. Prior to embarking on a large scale trial of HIIT-induced disease     modification, this pilot study aims to demonstrate that HIIT can produce measurable responses     in disease activity scores and peak VO2in persons undergoing routine pharmacologic treatment     for RA.   "
57851|NCT02528331|"     The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered     simultaneously with elements of cognitive behavioral therapy/exposure-response prevention     (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive     disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and     an investigational treatment modality (TMS). The investigators will compare the Yale-Brown     Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical     improvement. The side effects from TMS include, but are not limited to, headache, seizure,     and general pain. CBT has minimal side effects other than mental discomfort during the     exposure sessions. For safety concerns, pregnant women and subjects with seizure-related     history will be excluded as well as other indicated conditions in the details protocol.   "
57852|NCT02528318|"     The primary objective of this study is to evaluate the safety and tolerability of lucinactant     for inhalation, administered as an aerosolized dose in up to four escalating doses to preterm     neonates 26 to 28 weeks gestational age who are receiving nasal continuous positive airway     pressure (nCPAP) for respiratory distress syndrome (RDS) compared to neonates receiving nCPAP     alone.   "
57854|NCT02528292|"     This study will be an open label observational prospective study assessing the clinical     efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific     regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid     arthritis.      Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the     UK. It affects approximately 1% of adults and causes considerable morbidity, substantially     reduces quality of life and has a significant mortality. It results in large direct medical     costs as well as extensive indirect social costs. Despite the significant therapeutic     progress following the introduction of antiTNFα, a cure for RA is still elusive. At present     the reasons for the variation in clinical response are not known. The main aim of this study     is to test the hypothesis that there are distinct molecular and cellular phenotypes present     within the synovial tissue that define specific disease subsets and provide characteristic     prognostic implications. In particular, the aim is to assess the relationship between the     presence of ectopic lymphoneogenesis (ELN) within the rheumatoid synovial membrane and     response to antiTNFα therapy.   "
57855|NCT02528279|"     Malaria is a protozoan infection transmitted by anopheline mosquitoes. The most severe forms     are caused by Plasmodium (P) falciparum and to a much lesser extent by P. vivax.      Although the interest in research on malaria has increased during the last years, yet little     research is conducted on the neglected malaria species P. ovale and P. malariae. P. ovale     being first described in 1922, it still remains unclear whether it displays dormant     pre-erythrocytic liver stages, so called hypnozoites, or not. Primaquine, the only marketed     drug with liver stage activity at present, can cause severe hemolysis in glucose-6-phosphate     dehydrogenase (G6PD) deficient persons and methemoglobinemia. Because G6PD is widely spread     in Central Africa, it is important to explore whether additional intake of liver-active     medication is really needed and on this account further research to investigating new     treatment options with liver stage activity should be conducted.      While, due to widespread resistance, treatment recommendations for P. falciparum and mixed     infections have switched from chloroquine to the safer applicable artemisinin-based     combination therapies (ACTs), World Health Organization (WHO) guidelines still suggest     chloroquine as first line treatment for P. malariae and P. ovale mono infections. Further     studies assessing alternative treatment options are largely missing.      Summing up the current situation for both topics shows the need for further research.     Therefore this study aims to assess the evidence and characterize the frequency of relapses     in P. ovale infections with respect to differences between its subspecies as well as the     effectiveness of the ACT artemether-lumefantrine in P. malariae and P. ovale mono- and mixed     infections.   "
57856|NCT02528266|"     This study is conducted to clinically assess safety and performance of the Polyganics nerve     capping device for the treatment of symptomatic neuroma. There is sufficient clinical     experience with regard to the safety of the commercially available nerve guide, NEUROLAC®.     This new nerve capping device is identical in material and manufacturing. The exception is in     design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed)     end. This study will be conducted to obtain data on the clinical performance of the capping     device's ability to isolate the nerve end, resulting in a reduction of pain of experienced     from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.   "
57857|NCT02528253|"     This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered     by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective     of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to     placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the     long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the     treatment of chronic low back pain. In addition, the study will evaluate the effectiveness     and long term safety profile of tanezumab treatment for chronic low back pain compared to     tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic     low back pain.   "
57858|NCT02528240|"     This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during     endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone     healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone     healing will be studied. The trial design is an open randomized controlled clinical trial     with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF     (experimental group), the other half without (control group). The control and experimental     group will be divided in 2 subsequent groups: half of the participants will receive an     occlusive membrane during EMS, the other half not.   "
57859|NCT02528227|"     The purpose of this study is to adminster one of two education programs to parents of preterm     infants in the NICU to evaluate language and cognitive outcomes of their infants.   "
57860|NCT02528214|"     Primary Objective:      To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of     maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.      Secondary Objectives:        -  To evaluate the safety and tolerability of dupilumab.        -  To evaluate the effect of dupilumab in improving patient-reported outcomes.        -  To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug          antibodies.   "
57861|NCT02528201|"     A clinical trial to assess the effect of celecoxib 200 milligrams (mg) once daily and 400     milligrams (mg) once daily compared to diclofenac three times daily in the treatment of     Ankylosing Spondylitis (AS) for 12 weeks. This will be used to confirm the results of a prior     6 week trial.   "
57862|NCT02528188|"     The purpose of this study is to compare the long-term joint safety and efficacy (pain relief)     of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory     drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.   "
57863|NCT02528175|"     This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided     focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination     with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer.     Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited     for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral     chemotherapy.   "
58797|NCT02515942|"     The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days)     intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as     compared to sham in subjects with geographic atrophy.   "
57865|NCT02528149|"     Fibromuscular dysplasia (FMD) is localized structural defects in the arterial wall, whose     innate or acquired character is still unknown. This segmental non atheromatous injury, leads     to stenosis of the arteries of small and medium caliber. Renal arteries are the most commonly     affected with 60-75% of total fibrodysplasia. Three histological subtypes have been     described: intimal, medial and peri-medial. They are not mutually exclusive and can be     observed in the same patient.      This is a rare blood disease, occurring in children and young adults. In this young     population with long life expectancy, these aneurysmal lesion are associated with 10% risk of     rupture. To date, no data have shown in the literature that FMD is link to genetic causes, or     if there is specific histopathologic lesions for non-atherosclerotic renal artery aneurysms.      To answer these questions, Cardiovascular Surgery Unit of the University Hospital of     Saint-Etienne, French national reference center for renal artery surgery, in association with     the Reference Center for Rare Vascular Disease in Paris, designed the first study for     pathological and genetic characteristics of dysplastic renal artery aneurysms in young     patients.   "
57866|NCT02528136|"     Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.   "
57867|NCT02528123|"     The purpose of this study is to validate the safety and effectiveness of treating myopia     (short-sightedness) higher than -10D using small incision lenticule extraction (SMILE) with     the VisuMax femtosecond laser.   "
57868|NCT02528110|"     The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal     metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is     that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of     overall survival.   "
57869|NCT02528097|"     Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of     end-stage liver disease with a mortality of up to 10% primarily due to the development of     kidney failure. Current standard practice is to treat this infection with broad spectrum     antibiotics and salt-poor albumin administration on day one and three of treatment. In this     study the investigators test the hypothesis that the administration of a second dose of     albumin at 48 hours only to patients with renal insufficiency is as effective at preventing     kidney failure as administering the second dose to all patients at 72 hours. In addition, a     kidney function determined approach to albumin dosing may lead to substantial cost and     resource saving from decreased albumin use without compromising treatment efficacy.   "
57870|NCT02528084|"     To determine if patients who undergo a 6-week online yoga exercise treatment differ from     those who undergo a 6-week online standard exercise intervention and patients who do not     undergo any treatment (the control).   "
57871|NCT02528071|"     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory     muscles and can lead at short term to respiratory failure. The occurrence of respiratory     failure is associated with morbidity and an increased mortality. To date, respiratory muscle     weakness is predicted from the reduction of vital capacity, maximal inspiratory force,     nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these     indices is low.      The investigators hypothesize that an endurance test of diaphragmatic work would be more     sensitive to respiratory muscle involvement than maximal respiratory force.      Consequently, the investigators assessed diaphragmatic performance through an isocapnic     hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the     occurrence of respiratory failure. The investigators make the hypothesis that IHT will be     altered earlier than maximal inspiratory force   "
57872|NCT02528058|"     The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular     retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent     vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to     evaluate ultrastructure with electron microscopy.   "
57873|NCT02528045|"     The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic     traction maculopathy who received viterctomy including internal limiting membrane peeling and     scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal     reattachment and macular hole closure, the shape of staphyloma determined by optical     coherence tomography and 3-dimensional magnetic resonance imaging were assessed.   "
57874|NCT02528032|"     Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with     biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT     restores contraction coordination between different regions of the left ventricle, which     yields a significant improvement in LV systolic function, symptoms, exercise tolerance and     quality of life. In the longer term, treatment with resynchronization induces a reverse     remodeling of the left ventricle and a decrease in mortality and morbidity (hospitalization     for heart failure). Nevertheless, even if a majority of patients treated with CRT feel the     benefit, some (up to 40% depending on the response criteria of CRT) do not experience     significant improvement (nonresponders). Echocardiography and imaging have not so far     demonstrated their added value to optimize delivery of CRT. Monocentric promising work on     limited numbers of patients, however, were carried out. Meanwhile, equipment for delivering     CRT evolves and new probes with four poles stimulation of the left ventricle are now used.     The objective of this research is to validate new sequences of ultrasound processing     estimating the CRT. These tools are based on usual echocardiographic examination of patients   "
57875|NCT02528019|"     Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2)     has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors     or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their     glucose-lowering effects remains unknown.   "
57876|NCT02528006|"     For adductor spasmodic dysphonia, there is a need for establishing a new therapy under the     present circumstance where no standard therapy has been established yet and existing     therapies fail to provide permanent effect. Evaluation of the efficacy of type 2 thyroplasty     using titanium bridges will expand the therapeutic options available for adductor spasmodic     dysphonia and establishment of a standard therapy.   "
58017|NCT02526173|"     The investigators will examine the beneficial impacts of applying of dHACM on the preserved     neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted     laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing     and reduction of inflammation at the operative site and thus an acceleration of return of     potency regulating cavernosal nerves.   "
57877|NCT02527993|"     Obesity is increasing worldwide and consequently the need for efficient treatment     opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed     bariatric procedures used in the treatment of severe obesity. The surgery results in     significant and sustained weight loss and has a beneficial effect on blood glucose     regulation.      However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia     years after the operation, with symptoms varying from mild dizziness to confusion, loss of     consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to     an oral glucose load are believed to play a role in the syndrome, which is not yet fully     understood. There are no current treatment guidelines beside dietary recommendations.      The purpose of this study is to compare different pharmacological treatments on daily blood     glucose variations as well as postprandial hormonal and autonomous changes in subjects with     symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.   "
57878|NCT02527980|"     The proposed research will provide in-depth, longitudinal data, based on real-time reports,     which will address key priorities for the FDA including, increased understanding of the     relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions     in combustible cigarette (CC) use, 3) attempts to quit CC use and the success of those     attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.   "
57879|NCT02527967|"     Although there is evidence for reducing complication rate and improving recovery after the     implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery,     most published papers include patients undergoing open resections. The aim was to analyse     factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal     surgery for cancer combined with ERAS protocol.   "
57880|NCT02527954|"     In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and     Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS),     the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without     microdeletions who undergo assisted reproduction in their clinics.   "
57881|NCT02527941|"     A non-randomized, interventional, longitudinal clinical study to quantify the impact of     bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.   "
57882|NCT02527928|"     Invasive fungal infections (IFIs) are complications that happen in the hospital, usually in     patients hospitalized for long periods in intensive care units (ICU) after invasive     procedures, and in specific populations, such as cancer patients. The aim of this study is to     determine the direct and indirect hospital costs with different formulations of amphotericin     B (deoxycholate, lipid complex and liposomal) in different public and private hospitals in     the city of Curitiba, Paraná, Brazil.   "
57883|NCT02527915|"     The purpose of this study is to assess whether electronic consultations between primary care     providers and psychiatrists affects mental health services delivered in primary care     settings.   "
57884|NCT02527902|"     The estimation of the cardiovascular risk in the general population must take into account     small renal disturbances, as the microalbuminuria. Conversely certain parameters of the     cardiovascular risk influence the evolution of renal diseases, for example the arterial high     blood pressure.      The measure of the activity of the autonomous nervous system, and especially the     quantification of its variability, is a means to estimate the cardiovascular risk. The     investigators formulate the hypothesis that the variability of the autonomous nervous system     is an additional clinical element for the evaluation of the evolutionary risk of renal     diseases.      The aim of this study is to compare the variability of the autonomous nervous system during     the various evolutionary stages of the renal disease.      The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined     glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the     renal mesangium (at list 1+) by immunofluorescence.   "
57885|NCT02527889|"     The purpose of the study is to evaluate the effect of resistive exercise on forearm blood     flow and tissue oxygenation among breast cancer survivors with or at risk for breast     cancer-related lymphoedema (BCRL).   "
57886|NCT02527876|"     The purpose of this study is to evaluate how physical activity levels change in young adults     when they start a specific exercise program.   "
57887|NCT02527863|"     Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and     sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which     stimulates V1-receptors in the vascular bed and may change both central and brachial     hemodynamics and plasma concentration of vasoactive hormones.      The purpose of the study is to measure the effects of tolvaptan on renal handling of water     and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide     (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA) in patients with autosomal dominant     polycystic kidney disease.   "
57888|NCT02527850|"     Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of     this study is to investigated the effect of B-cure laser on muscle performance and recovery     after intense exercise.   "
57889|NCT02527837|"     The purpose of this study is to investigate how the effect of infused sodium nitrite differs     in hypertensives compared to healthy age and sex matched controls. The effects on renal     handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones,     peripheral (brachial) and central blood pressure will be evaluated.   "
57890|NCT02527824|"     This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan,     and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.   "
57891|NCT02527811|"     1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary          insufficiency and safety in pediatric patients undergoing scheduled CPB open heart          surgery to treat Complex Congenital Heart Disease        2. Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic          instability as well as other post-operative organ recuperation and its impact on          hospital stay & cost   "
57892|NCT02527798|"     This study will describe the safety of furosemide in premature infants at risk of     bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics     (PK) of furosemide.   "
57893|NCT02527785|"     This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan,     and S-1 as the first-line chemotherapy in patients with advanced gastric cancer.   "
57895|NCT02527759|"     The purpose of this study is to examine the relative predictive ability of the derived     monitoring instrument to determine post discharge instability and 30-day outcomes in patients     discharged with HF. The primary hypothesis is that variables in the monitoring instrument,     individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea,     fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure,     mental condition, medication adherence, and overall well-being will be reported by     participants on a daily basis and considered indicators for 30-day outcomes of stability,     re-hospitalization, or mortality.   "
57896|NCT02527746|"     A Phase I, dose escalation study to evaluation the safety and     pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up     to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were     assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.   "
57897|NCT02527733|"     The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal     vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully     investigated. The purpose of this study is to compare the changes in retinal sensitivity     after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in     eyes with BRVO.   "
57898|NCT02527720|"     The investigators plan to establish the efficacy of a novel breathing-based mindfulness     training (BBMT, a much simplified, easy-to-use version of standard MM) for problem drinking,     and test whether impulsivity mediates this effect among a sample of student problem drinkers     (i.e., > 8 on AUDIT, the problem drinking Screening Test). The specific aims of this pilot     study are as follows:        1. to modify and further develop the easy-to-use BBMT program for directly targeting          impulsivity to produce an indirect reduction in problem drinking among college students;        2. to investigate the feasibility and preliminary efficacy of applying BBMT for reducing          problem drinking with a pilot randomized controlled trial (RCT);        3. to examine changes in impulsivity, as measured by both behavioral and self-report          assessments, as one of the possible mediators in the effect of BBMT on problem drinking,          with control for changes in perceived stress and anxiety.   "
57899|NCT02527707|"     A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamic activity of titrating-dose lonafarnib in combination with ritonavir in     patients chronically infected with hepatitis delta virus   "
57900|NCT02527694|"     This study aims to compare the quality of emergency medical services cardiopulmonary     resuscitation between flexible stretcher and standard stretcher during ambulance transport to     hospital among out-of-hospital cardiac arrest patients.   "
57901|NCT02527681|"     The primary objective is to characterize the pharmacokinetics of single doses of ceftobiprole     in neonates and infants aged ≤ 3 months. The secondary objective is to evaluate safety and     tolerability of ceftobiprole in neonates and infants aged ≤ 3 months.   "
57902|NCT02527668|"     Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score     below pharmacologic treatment indication have limited treatment options in the prevention of     osteoporosis/treatment of osteopenia. Further, there is a concern about long-term side     effects of bisphosphonate treatment among young postmenopausal women, and hormone replacement     therapy has been controversial. In a pilot study 20 microgram Calcifediol Hy.D improved     several muscle related function in this target population within 4 months of treatment, which     can help to prevent falls and associated bone fractures. Thus the main aim of this study is     to test whether Calcifediol Hy.D at a daily dose of 20 μg / day improves muscle function     (lower extremity test battery) compared with (1) placebo and compared with (2) 3200 Vitamin     D3 IU per day, at 3 and 6 month follow-up. As a secondary and exploratory objective of this     study, the investigators will compare the beforementioned doses on muscle strength and the     quality of the bones, beside muscle mass, body composition and systolic and diastolic blood     pressure measurements.   "
57903|NCT02527655|"     The Men on the Move Study is a randomized, controlled, feasibility study designed to address     the health problem of physical inactivity in older men.   "
57904|NCT02527642|"     This is a randomized, controlled, single-center study in otherwise healthy infertile female     subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will     be among those patients who have been diagnosed with infertility and are planning to undergo     IVF at the centers where this study is being performed. The patients will have undergone the     usual informed consent procedure at the center.   "
57905|NCT02527629|"     Evaluation of decellularized human heart valves for aortic heart valve replacement in     comparison to current valve substitutes.      Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention     and explantation.      Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.   "
57906|NCT02527616|"     This is a single-blinded, randomised, crossover investigation comparing the investigational     device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV)     infusion method used for obtaining FFR measurements. All subjects requiring on a clinical     basis a pressure wire assessment of intermediate coronary artery stenosis(es) will be     eligible to take part in the investigation.   "
57907|NCT02527603|"     To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for     anterior shoulder dislocation and the Spaso method performed by a physician.   "
57908|NCT02527590|"     The stimuli used in the evoked potentials are electrical or laser. They are started and     synchronized with the collection of the EEG by signals TTL (transistor-transistor logic).     Investigators propose to validate a pneumatic stimulator delivering the compressed air sync     with the EEG. It has two advantages over existing stimuli: Is capable of inducing in patients     an allodynic response, excessive, painful, in response to a stimulation painless rarely     obtained with laser or electrical stimuli. Therefore, the pneumatic stimulation is a means to     study allodynic evoked potentials unknown to date.      It must be possible with a single stimulator to explore non-painful sensations and allodynic     sensation , compare them with one device. The differences are the abnormal responses. This     validation assumes evoked potential recording 1. somatosensory (low stimulation) then 2.     allodynic (only in patients). The study therefore provides for the registration 100 potential     for each of these two modalities in patients and only for the painless pneumatic modality in     volunteers.   "
57909|NCT02527577|"     The indications liver cancer surgery currently booming due to the increase in surgical     techniques and instruments for a more secure resection of liver tissue with a significant     reduction in bleeding or surgical complications. This allowed to expand surgical indications     in the most fragile patients so assuming optimized anesthetic care.      So far, the technique of analgesia reference to this surgery remains administration of     morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is     against-indicated because of induced bleeding disorders by surgery.      Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the     abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective     anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging     surgical approach represent a significant share of post operative pain.      This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.   "
57910|NCT02527564|"     The purpose of this study is to evaluate the efficacy of suvorexant, added to existing     medications, for treatment-resistant insomnia in individuals with bipolar disorder. The     investigators hypothesize that participants receiving suvorexant for one week will experience     significantly greater improvement in sleep duration compared to participants receiving     placebo.   "
57911|NCT02527551|"     Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown     etiology, characterized by generalized body pain, hyperalgesia and other functional and     emotional comorbidities. Women are predominantly affected. Long term prognosis of FMS might     be severe by its physical and psychological consequences. The etiology of FMS remains unknown     but recent studies suggest a disorder of central pain modulation, neurotransmitters,     sympatho-adrenal and hypothalamic-pituitary-adrenal system and peripheral muscles issues.     Indeed, muscular abnormalities with a decrease of ATP and micro vascularization have been     reported, inducing muscle weakness and local biochemical changes that participate to pain     hyper sensitivity. Treatment of FMS is only symptomatic, often difficult, associating     pharmacological and non-pharmacological therapies. Massages are largely used in FMS and are     included in chronic pain management recommendations.      Massages are recognized as haptic when the hands of the practitioner move on the skin of the     patient; haptic massage is superficial if the pressure applied on the skin is similar to the     weight of the hand and it's a deep haptic massage when the pressure applied is over the     weight of the hand, allowing reaching deep muscle structure. Deep haptic massages are largely     used for athlete to improve muscle recovery and treat tendinitis. All massages evaluate in     FMS are superficial haptic massage; they are recognized as efficient on pain, anxiety and     depression if they are performed at least on 5 weeks but these effects are transient et     remain to be optimized. The efficacy of deep haptic massage has not been evaluated in     pathological conditions. The investigators hypothesize that, in FMS patients, deep     intramuscular maneuvers may solicit sensitive receptors, stimulating large caliber fibers A     lemniscal conveyed by the way that bypass chronic pain information carried by the C fibers of     the extra-lemniscal pathway: this is the Gate Control theory for inhibiting pain     information.   "
57912|NCT02527538|"     The beach chair position for shoulder operation induces hypotension during general     anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia.     Masimo is a pulse oximetry which shows pleth variability index noninvasively. The pleth     variability may predict the hypotension during beach chair position.   "
57913|NCT02527525|"     The incidence of type 1 diabetes (T1D) in young children (age <6 years) is rising. Disease     management guidelines offered by the ADA and other diabetes care organizations place a high     burden of responsibility onto these children's parents and caregivers to check blood sugar,     administer insulin, and monitor diet and physical activity to maintain tight glycemic     control. Unfortunately, this occurs at a vulnerable time in life when children's behavior is     unpredictable, their T1D is difficult to control, parenting stress is elevated, and     caregivers are strained by normal child caretaking routines. T1D education and support tends     to be highly concentrated at diagnosis/during the inpatient stay, and requires rapid     knowledge and skill acquisition on the part of parents. Not all families respond equally well     to this teaching model, and many need more guided practice, problem-solving assistance, and     behavioral supports than can be offered in a one-size-fits-all patient education approach.     Our research will attempt to better meet the needs of individual families through a clinical     behavioral stepped care intervention for T1D in parents of young children by using real-time     glycemic control and [parental depression indices] to intensify management support when     indicated. Primary caregivers of young children (<6 years) newly diagnosed with T1D will be     randomized to either a 3-step stepped care (treatment) or usual care (comparison) condition.     Stepped care components include: T1D management support delivered by trained lay parent     consultants (Step 1), T1D parenting strategies and mealtime behavior management delivered by     bachelor's level behavioral assistants (Step 2), and individualized diabetes     education/management planning with a certified diabetes nurse educator and [consultation with     a diabetes team clinical psychologist] (Step 3). Biomedical and psychosocial measurements     (including A1c, depressive symptoms, mealtime behavior, parenting stress, quality of life)     will occur at baseline and 3-month intervals for up to 15 months post-diagnosis. The results     of this work will ultimately lead to a more practical approach to T1D education and     management that can be translated more easily into a variety of clinical practice settings to     support young children's T1D management.   "
57914|NCT02527512|"     This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal     patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of     povidone-iodine and normal saline irrigation at reducing bacterial contamination of the     surgical wound will be measured by collecting cultures before and after irrigation.   "
57915|NCT02527499|"     The four purposes of this study are: 1) to examine the feasibility of combining modified     ride-on cars with bimanual training (ROCBT) on mobility, socialization and motor function in     toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to     have more manual explorations and social interactions with ROCBT through observation and     wrist-worn accelerometers; 3) to determine the critical factors of using the modified ride-on     toy car on family perceptions and participation.      Independent mobility is believed to be essential for perceptual-motor, cognition, language     and social skill development. It is important to increase independent mobility in toddlers     with disabilities and further enhance their development, especially socialization. Assistive     and power mobility devices allow toddlers with disabilities to move independently within     their environment and may increase the opportunities to explore and interact with people and     environment. However, issues to consider before prescribing an assistive device include     factors such as age, accessibly to community environments, cost, and social acceptance of the     device and the adaptability of the device to growth. To address these limitations and meet     toddlers' needs, the concept of using modified ride-on toy cars in therapy becomes a novel     application. Study has demonstrated the use of toy cars enhanced a child's motivation,     socialization and family participation. This study is further to combine the use of     customized, modified ride-on toy cars with bimanual training, to enhance the independent     mobility, manual exploration and socialization through low-cost, family-centered approach. It     will also improve family's understanding of children's capabilities, which improve their     development.      Investigators will recruit 75 children with who are between 1 to 3 years old and diagnosed as     motor delay (>1.5 sd). They will be randomly assigned to one of the following three groups:     ROCBT treatment group, early mobility training group and regular therapy group. The whole     study duration will be 18 weeks, including 9-week intervention and 9-week follow-up; the     total amount of treatment will be equal for two groups. Standardized assessments are provided     for a total of three times during the study, including the time before and after the     intervention and in the end of the follow-up phase. The ROCBT and early mobility training     programs will be administered by the therapist and include 120 minutes/per session, 2     sessions/per week. The research team will visit the hospital once/per week to provide 60     minutes videotaping and wearing wrist-worn accelerometers. The regular therapy group will     continue their regular therapy without any additional car driving training. The research team     will visit them once/per week for the assessments. The assessments include standardized     measurements and behavior coding from the videotapes and accelerometers. The findings of this     study will help to understand the feasibility and effectiveness of combining the low-tech     modified ride-on cars with bimanual training on advancing children's mobility and     socialization. They can be used in the clinic or school and are a low cost alternative or     addition to other mobility devices. They may provide a novel therapeutic tool to improve     mobility, socialization, family participation and development.   "
57916|NCT02527486|"     This is a multicenter, prospective observational cohort study, in which patients with chronic     airway diseases including chronic obstructive pulmonary disease(COPD), asthma, asthma-COPD     overlap syndrome (ACOS) will be recruited.   "
96996|NCT02016586|"     To evaluate the benefits of a lactation support intervention, in conjunction with maternal     nutritional supplementation.   "
57918|NCT02527460|"     Background:      HIV can sometimes cause HIV-associated neurocognitive disorder, or HAND. HAND is     HIV-associated neurocognitive disorder. It can affect memory, thinking, or concentration. It     can cause mood changes. HAND may be caused by HIV hiding in the central nervous system then     causing inflammation. Researchers want to see if a drug for inflammation (Anakinra) can help     people with HIV.      Objective:      To see if a drug for inflammatory diseases is safe for people with HIV-infection on     antiretroviral therapy.      Eligibility:      Adults 18-61 years old with HIV who are enrolled in another study.      Design:      Participants will be screened with medical history, physical exam, and blood and urine tests.      Participants will have up to 15 study visits over 16 weeks.      At study visit 1, participants will have:        -  Screening tests repeated.        -  Brain magnetic resonance imaging (MRI) scans. They will lie on a table that slides into          a metal cylinder in a strong magnetic field. They will get a dye inserted by a thin          plastic tube in a vein.        -  Lumbar puncture. The lower back will be numbed. A needle will collect fluid from between          bones in the back.        -  Tests of memory, thinking, and attention. Participants may also fill out forms and do          tasks.      Participants will learn how to inject the study drug. Over 8 weeks, they will give themselves     the study drug at home every day. They will do up to 3 injections at once. They will write     down their injections and any side effects.      Participants will have 5 weekly visits while taking the study drug. They will answer     questions and have blood drawn.      At weeks 8 and 16, they will have a visit that repeats visit 1.   "
57919|NCT02527447|"     Background:      -Acute myeloid leukemia (AML) is a cancer of the white blood cells. It can be fatal. Standard     treatment involves intensive chemotherapy. Not all treatment works. AML that has not     responded to treatment (refractory) or that has returned after treatment (relapsed) is     high-risk even with treatment. Success of therapy is normally determined after 28 to 56 days.     This study will see if a blood test on day 4 of therapy can help identify earlier those who     will not respond.      Objectives:      -To see if a blood test on day 4 of therapy can help identify those who will not respond to     treatment for AML.      Eligibility:      -People ages 18-70 who have refractory or relapsed AML and have had at least one previous     therapy for it.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Participants will have:        -  Several blood tests.        -  Bone marrow exams: a needle is inserted into the hip to take cells from the bone marrow.        -  Echocardiogram: a small probe is held to the chest to take pictures of the heart.        -  ECG: soft electrodes are stuck to the skin. A machine records the heart s signals.        -  CT scans: they will lie in a machine that takes pictures of the body.        -  Standard chemotherapy.        -  Possible transfusions of blood products such as red blood cells or platelets.        -  Participants will be expected to stay in the study typically for 2 3 months. This will          include inpatient treatment. Inpatient stay normally will be 1 or 2 months.   "
57920|NCT02527434|"     A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with     Advanced Solid Tumors   "
57921|NCT02527421|"     This study evaluates the potential of HPA suppression in adolescent patients with moderate to     severe plaque psoriasis when using DFD01 Spray (twice daily for either 15 or 29 days) vs.     Comp01 Lotion (twice daily for 15 days).   "
57922|NCT02527408|"     This study will address the feasibility of using wrist-worn fitness trackers to monitor     hospital inpatients. The study is being conducted in the Intensive Care Unit where patients     are closely monitored, in order to provide gold standard measurements of heart rate, and     accurate estimates of sleep quality.   "
57923|NCT02527395|"     The purpose of this prospective study is to investigate how close Heat Pain Detection     Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical     pain model Brief Thermal Sensitization.      Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min.     heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing     Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary     hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.   "
57924|NCT02527382|"     The purpose of this study is to check if there is a difference in peritoneal contamination in     patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.   "
57925|NCT02527369|"     This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive     temporary reduction of thighs circumference by disruption of adipocyte cells.   "
57926|NCT02527356|"     The three purposes of this study are: 1) to examine the feasibility and effects of ride-on     car training with two different postures on mobility and socialization in toddlers with     disabilities; 2) to quantify whether toddlers with disabilities are able to have more     exploratory behaviors and social interactions with ride-on car training through observation     and wrist-worn accelerators; 3) to determine the critical factors of using the different     modes of modified ride-on toy car on family perceptions and participation. Independent     mobility is believed to be essential for perceptual-motor, cognition, language and social     skill development. It is important to increase independent mobility in toddlers with     disabilities and further enhance their development, especially socialization. Assertive and     power mobility devices allow toddlers with disabilities to move independently within their     environment and may increase the opportunities to explore environment and interact with     people. However, issues to consider before prescribing an assertive device include factors     such as age, accessibly to community environments, cost, and social acceptance of the device     and the adaptability of the device to growth. To address these limitations and meet toddlers'     needs, the concept of using modified ride-on toy cars (ROC) in therapy becomes a novel     application. Studies have demonstrated the use of toy cars enhanced a child's motivation,     socialization and family participation. Investigator preliminary results of the group study     showed significantly increased mobility, socialization and decreased parenting stress level     after the toy car training in toddlers with disabilities.      More percentages of participants in the treatment group had clinical meaningful improvements     on mobility and social function than the control group. Evidence supported that specificity     of psychological changes associated with different modes of locomotion, particularly the loco     motor experience involving motor activity, e.g., postural control; the perceptual information     (e.g., periphery optical flow) and action experience affect psychological development.      Therefore, this study is further to examine the effects of ride-on toy car training with two     different postures, i.e., sitting and standing , on independent mobility, exploration and     socialization through low-cost, family-centered approach. It will also improve family's     understanding of children's capabilities, which improves their development. Based on the     power analysis from the preliminary results of investigator group study, investigators will     recruit 60 children with disabilities who are between 1 to 3 years old and diagnosed as motor     delay (>1.5 sd). They will be randomly assigned to one of the following three groups: ROC-Sit     group, ROC-Stand group and regular therapy group. The whole study duration will be 24 weeks,     including 12-week intervention and 12-week follow-up; the total amount of treatment will be     equal for three groups. Standardized assessments are provided for a total of three times     during the study, including the time before and after the intervention and in the end of the     follow-up phase. The ROC-Sit and ROC-Stand programs will be administered by the therapist and     include 120 minutes/per session, 2 sessions/per week. The research team will visit the     hospital once/per week to provide 60 minutes videotaping and let participants wear wrist-worn     accelerators. The regular therapy group will continue their regular therapy without any     additional car driving training. The research team will visit them once/per week for the     assessments. The assessments include standardized measurements and behavioral coding from the     videotapes and accelerators.      The findings of this study will provide a novel therapeutic tool (i.e., combining the     low-tech modified ride-on cars with different postures) on advancing children's mobility,     socialization, family participation and development.   "
57927|NCT02527343|"     The purpose of this study is to evaluate the efficacy and safety of volanesorsen     (IONIS-APOCIIIRx) given for 52 weeks in patients with Familial Partial Lipodystrophy.   "
57928|NCT02527330|"     Heart failure from myocardial iron deposition is a severe complication for patients with     hematological disorders who need repeated blood transfusions. Increased cardiac iron content     impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis,     and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited     in the myocardium.      Cardiovascular magnetic resonance (CMR) imaging is used as noninvasive method to evaluate the     amount of iron in the heart. Myocardial T2* value has been shown to correlate well with     biopsy-derived iron concentration in the heart, and myocardial T2* values less than 20ms     (indicating elevated iron) were found to be associated with LV dysfunction and improve in     concert with LV function during recovery. The majority of the recent studies about myocardial     iron overload and the effect of iron chelation therapy were focused on patients with     transfusion-dependent hematological disorder, especially beta-thalassemia major.      The objective of this 3-year project is to evaluate myocardial iron deposition in patients     with heart failure, induced by variable causes. With myocardial T2* imaging, the     investigators will analyze the decreased signal intensity in the ventricular septum and     quantitatively acquire the T2* value as marker for myocardial iron deposition. The first year     is a cross-sectional study. The investigators aim to compare the severity of myocardial iron     deposition of normal subjects and that of stable HF patients in recovery with normal or     impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each     group. In the 2nd and 3rd years, the investigators plan a prospective longitudinal study of     40 subjects. Enrolled patients will be evaluated with cardiac T2* imaging at three time     points, i.e., disease onset, 6 months and one year after treatment, and will be followed up     until the end of this project (1.5~3-year follow up). In total 120 MR scans will be performed     in the 2nd and 3rd years. The presence and severity of myocardial iron deposition will be     correlated with the disease course, patient biochemistry data and clinical outcome.   "
57929|NCT02527317|"     This is a prospective, non-interventional, single arm study, which is examining doxorubicin     and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast     cancer.   "
58029|NCT02526017|"     This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and     clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced     cancers.   "
57931|NCT02527291|"     We hypothesized that the stress of cardiac surgery and cardiopulmonary bypass can cause     reactivation of a latent CMV infection and that reactivation might be more prevalent in     patients with complicated post-operative course. The study aims are:        -  To study whether cardiac surgery is a trigger for latent CMV reactivation and to compare          reactivation rate between sub groups of patient with complicated post-operative course          and non complicated post operative course.        -  To study the relationship between expression IL28 SNP rs12979860 and the risk of CMV          replication in the non immunocompromised patient undergoing cardiac surgery.   "
57932|NCT02527278|"     The research questions are:        1. What is the proportion of women undergoing hysterectomy after hysteroscopic          sterilization or laparoscopic tubal ligation?        2. What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy          after hysteroscopic sterilization or laparoscopic tubal ligation?        3. What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic          sterilization or laparoscopic tubal ligation?   "
57933|NCT02527265|"     Primary Objective:      -To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1     diabetes mellitus (T1DM).      Secondary Objectives:        -  To assess the ability to titrate the prandial and supplemental doses of Afrezza at each          meal.        -  To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4          to 17 years with T1DM.   "
57934|NCT02527252|"     The purpose of the current randomized clinical trial was to analyze the effectiveness of     craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric     endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac     index, and biochemical estimation of interstitial fluid in individuals with chronic low back     pain.   "
57935|NCT02527239|"     Pompe's disease is a very rare condition which causes weakness of the respiratory muscles and     may therefore cause symptoms of breathlessness or even respiratory failure, requiring the use     of a ventilator at night. Recently a treatment for this condition has become available as     well as a simple diagnostic test. However, we believe it is possible that there are patients     with this condition who are presently undiagnosed attending respiratory clinics.      We would like to complete an observational study of patients with respiratory muscle weakness     of an unknown cause, who are attending respiratory clinics at two London centres, to     determine whether patients attending these services have undiagnosed Pompe's disease.   "
57936|NCT02527226|"     This is a protocol to govern the prospective trial of facial nerve monitoring in patients     undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor     provides useful information to operating surgeons and if the information provided by the     facial nerve monitor can predict degrees of postoperative facial nerve paresis.      Additionally, the study will determine if performing daily facial rehabilitation exercises     provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.   "
57937|NCT02527213|"     To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing     analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial     28-day treatment phase.   "
57938|NCT02527200|"     This trial is conducted globally. The aim of this trial is to investigate the effect of     liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.   "
57939|NCT02527187|"     The main objective is to evaluate the concentration of allergen extract of Betula verrucosa     that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride     10 mg / ml in size.   "
57940|NCT02527174|"     This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the     polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus     cytarabine induction chemotherapy for previously untreated patients with acute myeloid     leukemia. (AML).   "
57941|NCT02527161|"     This is a prospective, non-randomized, longitudinal study of the clinical outcomes of     participants that receive the Stryker Triathlon® Total Knee System for Total Knee     Arthroplasty implanted using ShapeMatch® Cutting Guides.      Health status and functional outcome measures will be recorded to quantify functional status     of subjects before surgery and at each follow-up interval. This sub-study involved the     assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and     post-operatively.An assessment of post-operative patient outcomes compared to pre-operative     status was also analysed.   "
57942|NCT02527148|"     This is a prospective, randomized, longitudinal study of the clinical outcomes of     osteoarthritis patients treated by two different alignment philosophies for total knee     replacement. In this study ShapeMatch® cutting guides will be compared to the conventional     approach.   "
57943|NCT02527135|"     The purpose of this study is to determine whether regularly scheduled HIV sensitization text     messages (SMS) are effective in increasing HIV testing rates among young women in Kenya.   "
57944|NCT02527122|"     Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen     extracts, together with a positive and negative control, using 10 mg/ml histamine     dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be     tested in every patient in duplicate on the volar surface of the forearm..   "
57945|NCT02527109|"     The objective of the study is to examine the effect of Nifedipine, applied intra-anally     through our drug delivery device, on rectal pain severity in anal fissure patients that are     being managed with conservative treatment.   "
57946|NCT02527096|"     The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the     two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected     patients virologically suppressed with triple HAART.   "
57947|NCT02527083|"     Research suggests that the type of anesthesia used for surgery may affect intraoperative     stress hormone levels. There is also data to support that an increased level of stress     hormones leads to increased pain after surgery. The primary aim of this study is to determine     the effect of anesthesia type on long term pain after hernia surgery. In this study, patients     undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total     Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA)     maintained with sevoflurane. This will allow us to look at any differences in short and     long-term pain after hernia repair depending on type of anesthesia received.   "
57948|NCT02527070|"     Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations     in skin blood volume. The objective of the current study is to investigate a potential     relationship between MRT (minimum rise time, in time units) a measure derived from PPG and     the state of microvessels.      This study includes a 1-2 hour single session per subject during which PPG and other     microvascular and systemic variables will be monitored in response to non-invasive     interventions that are known to elicit microvascular responses.   "
57949|NCT02527057|"     Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually     worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25%     patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%.     Concurrent chemoradiation followed by surgery results in better survival than single-modality     treatments, and thus National Comprehensive Cancer Network(NCCN) recommends concurrent     chemoradiation as preoperative or definitive treatment for patients with stage II or III     esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some subgroup     of these patients, and its toxicity can increase perioperative mortality and delay or     preclude surgery. The ability to distinguish tumors that will respond or not respond to such     therapy remains an urgent priority. Diffusion-weighted magnetic resonance imaging(DW-MRI) is     based on the extent of mobility of water protons, as quantified by the apparent diffusion     coefficient (ADC). The ADC is a measure of the extent of free diffusion of water molecules     within tissues, which is mainly influenced by cell organization, size, and density. Cell     death leads to a loss of cell membrane integrity and density and leads to increases in ADC     values. The ADC has emerged as a potential biomarker of response to cancer therapy. However,     no one has published findings regarding the potential correlation between changes in ADC and     response of esophageal cancer to chemoradiation. Clarifying the potential predictive value of     DW-MRI for predicting response to such therapy is important for the delivery of appropriately     tailored treatment.      Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant     chemoradiation in esophageal squamous cell carcinoma（ESCC）, hence identify patients at high     risk of treatment failure from such therapy. Investigators will test this hypothesis with two     specific aims: (1) assess the ability of ADC to predict pathologic response to treatment; and     (2) assess the ability of ADC to predict disease-free survival and overall survival.   "
57950|NCT02527044|"     Assessing coronary graft functionality 6 months after in patients with complete arterial     coronary artery bypass grafting.   "
57951|NCT02527031|"     Cardiac arrest (CA) affects approximately 40,000 people in France. It is still a major cause     of death in a young population. Management of CA is defined by international recommendations,     detailed by learned societies in each country. It includes several links that are     interconnected for its optimisation. Despite all these improvements, no progress, or little     has been made in the survival of CA victims over the past few years in industrialised     countries, and the survival rate in France is 3% to 5%.      Refractory cardiac arrest is defined as failure, after 30 minutes of specialised     resuscitation. It used to be the standard to admit that there was no hope of spontaneous     cardiac activity and satisfactory neurological recovery after this period, except in cases of     CA with neuroprotection (intoxication, hypothermia).      External circulatory support such as extracorporeal membrane oxygenation (ECMO) makes it     possible to replace the circulatory activity of the myocardium and the respiratory activity     of the lungs.      In in-hospital cardiac arrest (CA) some teams use ECMO with an improvement in the survival     rate of 20% in comparison to standard resuscitation. This use demonstrates the possibility of     neurological recovery independent of the recovery of spontaneous cardiac activity which can     be differed.      These results encouraged the use of ECMOs in cases of out-of-hospital refractory cardiac     arrests. Patients who are victims of CA are resuscitated for 30 minutes on the spot where the     CA occurs. They are then transferred to a specialised centre. The significant improvement in     survival noted in in-hospital CAs was not observed in the French series of studies concerning     out-of-hospital CAs. This survival is currently estimated at 4%. This difference can be     partly explained by the difference in time between the beginning of cardiac massage and the     implementation of circulatory support by ECMO (low flow period). This time period is     directly correlated to survival.      To demonstrate the superiority of this strategy in terms of survival, investigators would     like to conduct a randomised comparative study of two strategies: 1) installation of an ECMO     between the 20th minute to the 30 minute of CA, directly at the site of the CA, by emergency     physicians and/or specifically trained resuscitators 2) On-site resuscitation optimised with     secondary transfer to the hospital for the implementation of support. The purpose is to     increase by 5% to 20% the survival of victims of out-of-hospital refractory cardiac arrests     with a good neurological prognosis.      Main objective:      The hypothesis is that pre-hospital ECMO will result in survival for 20% of the patients,     considering that the percentage of survival with in-hospital ECMO is less than 5%.      Main judgement criterion:      Survival with good neurological outcome (CPC 1 or 2) on discharge from intensive care or at 6     months      Secondary judgement criteria:      Success rate of the implementation of ECMO ECMO implementation time Immediate complications:     haemorrhage, infection Number of organ harvesting The quality of survivors' neurological     status according to the CPC neurological classification at D 28, 2 months and 1 year     Predictive indicators of the prognosis during cardiac arrest via cerebral and biological     monitoring Methodology, type of study: This is a prospective randomised study of current care     Sample size (SS, power, risk): A total number of 105 patients in each group will make it     possible to demonstrate at the alpha risk of 5% and a power of 1-β=90%, a significant     difference in favour of early pre-hospital ECMO compared to the current practice with     in-hospital ECMO.   "
57952|NCT02527018|"     Hypertensive disorders of pregnancy including preeclampsia are the leading cause of pregnancy     related mortality in the United States. Timely and appropriate management of hypertensive     disorders of pregnancy is critical to prevent complications such as kidney failure, HELLP     syndrome, disseminated intravascular coagulation, placental abruption, intrauterine fetal     demise, intracranial bleed, coma and death. (HELLP syndrome is a group of symptoms that occur     inpregnant women who have: H -- hemolysis (the breakdown of red blood cells); EL -- elevated     liver enzymes; LP -- low platelet count.) Hypertensive disorders of pregnancy include     gestational hypertension (HTN), chronic HTN, preeclampsia and preexisting HTN with     superimposed preeclampsia.      Hypertensive disorders may also lead to significant maternal and/or fetal morbidity. Based on     the severity of the disease process and gestational age of the fetus, decision needs to be     made whether to proceed with immediate delivery or continue expectant management. Meanwhile,     maintenance of optimal blood pressure, blood volume, and cardiac output are recommended to     preserve placental perfusion and to prevent unfavorable maternal and/or fetal outcomes.      Previous studies have demonstrated blood flow differences in pregnancies complicated by     preeclampsia vs. healthy pregnant women evidenced by decreased arterial compliance, increased     systemic vascular resistance and after load, and changes in blood volume and cardiac output.     Additionally, various serum markers have been tried to identify women with preeclampsia.     B-Type natriuretic peptide (BNP) has been consistently shown to be elevated in preeclampsia,     and serves as a marker of heart function and intra vascular volume status.      Continuous hemodynamic monitoring may play a crucial role in timely management of these     patients with severe disease due to the dynamic nature of the disease process. Existing     methods are not preferred in pregnancy due to their invasive nature, and there is lack of     validated non-invasive means to provide real time information on various hemodynamic     parameters including cardiac output in these critically ill pregnant women.      Among new cardiac monitoring devices, the Nexfin device (BMEYE, Amsterdam, Netherlands) has     recently been introduced. Nexfin device is a device approved by the Food and Drug     Administration (FDA) as a non-invasive reliable method of continuous measuring arterial blood     pressure in pregnant women. However there are no preliminary data on preeclamptic patients     using this device. The standard of care is to use a sphygmomanometer for blood pressure     monitoring. Additionally there are no studies comparing the hemodynamics of healthy and     preeclamptic women using Nexfin device. Nexfin is thought to be superior over other available     non-invasive methods as it is a safe and a considerably accurate method. Nexfin provides     continuous blood pressure, heart rate, cardiac output, stroke volume, systemic vascular     resistance and left ventricular contractility indices.      The study aims to determine if the non-invasive Nexfin device can be used to reliably     distinguish hemodynamics in preeclamptic vs. healthy pregnant women with singleton     pregnancies along with use of BNP levels. Investigators aim to recruit 33 healthy controls     and 33 subjects diagnosed with preeclampsia (mild and severe). Subject's systolic and     diastolic blood pressures will be measured using both the Nexfin device and a standard     sphygmomanometer (blood pressure meter). Additionally hemodynamic measure such as: heart     rate, cardiac output, stroke volume, systemic vascular resistance, and left ventricular     contractility will be recorded using the Nexfin device. Investigators will perform a blood     draw to measure BNP levels as an additional assessment of the hemodynamic changes in the two     groups.   "
57953|NCT02527005|"     Randomized controlled single blind prospective comparative study   "
57954|NCT02526992|"     Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease in adults and     is characterized by chronic inflammation of the joints leading to their destruction,     resulting in a major loss of function.      The investigators propose a pilot study for studying changes in bone microarchitecture with     High Resolution peripheral micro Computerized Tomography (HR-pQCT) in patients with RA     treated with anti-TNF(Tumor Necrosis Factor), with the measurement of micro-architectural     parameters in subchondral area near an inflammatory joint during the first 12 months of     initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).   "
57955|NCT02526979|"     The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral     suspension after single dose administration in children with neurogenic detrusor overactivity     (NDO) or overactive bladder (OAB).      This study will also evaluate the safety and tolerability as well as the acceptability and     palatability of mirabegron oral suspension after single dose administration in children with     NDO or OAB.   "
57956|NCT02526966|"     The anti-hinge region antibodies would be a relevant biomarker of IgA nephropathy. Beyond a     prognostic value (which could increase the risk of Renal Absolute), the longitudinal     monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in     place including a possible repetition renal biopsy); (2) to guide treatment decisions and (3)     in clinical research, as an outcome (in substitution for the occurrence of kidney failure) in     therapeutic trials IgA nephropathy.      This research project constitutes the first step in validating these antibodies biomarker of     IgA nephropathy and its main objective is to study the performance of the blood levels of     anti-hinge region antibodies in the diagnosis of progressive forms of histologically IgA     nephropathy as defined by the Renal Risk Absolute.      The secondary objectives of this project are to establish a bio-collection that will allow us     to search for other prognostic factors (genetic, cellular and serum) of IgA nephropathy and     to evaluate the performance of Renal Absolute risk by integrating Oxford score, the new     international histological classification.   "
57957|NCT02526953|"     The purpose of this study is to determine whether the combination of paclitaxel,     capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the     standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT)     in patients with squamous-cell anal cancer.   "
57958|NCT02526940|"     Although combined antiretroviral therapy (cART) has dramatically improved quality of life and     lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs. The Gut     Associated Lymphoid Tissue (GALT) is the largest reservoir of HIV-1, as it harbors most of     HIV target cells as activated memory Cluster of differentiation (CD)4+/CCR5+ T cells.     Intestinal T and B cells express α4β7 integrin, a gut mucosal homing receptor which binds to     gp120 HIV-1 envelope facilitating the infection of intestinal T cells and the early     establishment of the gut HIV reservoir. Intensive viral replication in the GALT leads to an     early impairment of mucosal immunity, due to the severe CD4+ T cells depletion, that could be     also explained by a lack of recruitment in the gut. Among T cells, interleukin-(IL-)17     secreting CD4+ T cells (Th17) are particularly depleted during HIV infection. This depletion     could be associated with HIV progression since these cells play a crucial role in the     maintenance of mucosal immunity. A dysbalance of the Th17/Treg ratio may reflect the loss of     the intestinal epithelial barrier integrity. These damages are responsible for an increase in     microbial translocation, which is associated with immune activation and progression to AIDS.     Several recent studies have shown that cART initiation during acute or early HIV-1 infection     reduces HIV DNA reservoir size and improves immune reconstitution in blood. Post-treatment     controllers, who started long-term cART early after HIV infection, have very low levels of     HIV DNA in peripheral blood mononuclear cells, similarly to elite controllers. Unlike most     HIV-infected individuals, they maintain an undetectable plasmatic viral load after several     years of cART interruption, suggesting that a weak reservoir is a prerequisite to achieve a     functional cure. By extrapolation, it could be hypothesized that the gut viral reservoir is     also decreased and that mucosal immunity is restored when cART is initiated during primary     phase of infection. The gut viral reservoir begins to form within the first days after HIV     exposure, and grows during acute HIV infection. Similarly, intestinal T cells are depleted     very early after infection, due to high viral replication, host immune response and bystander     effects. Most studies also concluded that long-term and optimal treatment can't fully restore     mucosal immunity. These observations led us to study the impact of time of cART start on the     size of viral reservoir and on immune reconstitution in the gut. For this, we analyzed the     virological and immunological characteristics of the rectal HIV reservoir of long-term     treated patients regarding their blood CD4+ T cells count at the time of cART initiation.   "
57987|NCT02526563|"     The primary investigators in this study plan to investigate serum concentrations of     ropivacaine in pediatric patients who already receive as standard of care a continuous wound     catheter after an iliac crest alveolar bone graft harvest for completion of a previous cleft     palate repair.      The goals of this study are 1) to determine serum concentrations (free, unbound) of     ropivacaine 2) To evaluate pain scores during the perioperative period to determine efficacy     of wound catheters for postoperative analgesia for iliac crest bone graft harvest.   "
57959|NCT02526927|"     The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces     starvation, stop of growth and impaired mineralization of bone tissue together with an     interruption of pubertal development. These consequences are initially reversible following     food intake return but can lead to a more irreversible status with low height, osteoporosis     and high fracture risk. The onset of the disease more and more early in life, with the first     stages of puberty suggest that these consequences will be even more severe as bone resistance     will be damaged by more profound effects on bone growth as well. It is therefore critical to     evaluate these bone metabolism alterations in order to better manage these patients.      At every age and in every clinical circumstance either physiologic or pathologic, high     resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation of     bone microarchitecture that is more informative than the global quantitative assessment given     by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of clinical     fracture risk.      Here, we propose to measure cortical parameters, such as cortical thickness which plays a key     role in bone biomechanical strength in young adults aged between 20 and 30 years-old, who had     developed AN as early as the during the first stages of puberty but no longer present,     compared to age-and sex-matched healthy volunteers. Other micro-architectural parameters will     also be studied. In an exploratory phase, we will evaluate these bone microarchitectural     parameters together with bone biological turnover markers and markers of sexual maturation in     adolescents or young adults 20 years-old or less, undernourished and currently managed for     AN.   "
57960|NCT02526914|"     The purpose of this study is to investigate the role of a one-time intranasal administration     of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and     competition in a healthy population of student controls.   "
57961|NCT02526901|"     The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and     long-term effects of exposure in early life on health consequences in Guangzhou, China. Data     are collected regarding environmental, occupational and lifestyle exposures as well as health     outcomes in later life. Biological samples including blood and tissue samples are also     collected from the participants.   "
57962|NCT02526888|"     The main objective of this study is to investigate whether repeated administration of a     cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of     presence in the blood) of ACT-541468   "
57963|NCT02526875|"     To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine     (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately     Controlled by Telmisartan Monotherapy   "
57964|NCT02526862|"     This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM-     mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU),     compared with other three usual preventive measures which consist in the use of three     different medical devices.   "
57965|NCT02526849|"     The purpose of this study is to evaluate the effect of fecal microbiota transplantation in     adults with slow transit constipation.   "
57966|NCT02526836|"     The aim of this study is to compare between complete mesocolic excision with central vascular     ligation and conventional surgery of colon cancer regarding number of harvested lymph nodes,     surgical outcome and complications.   "
57967|NCT02526823|"     Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation     related cardiac toxicity limits their clinical application, especially adriamycin. Adriamycin     has been gradually replaced by epirubicin. Polyethylene glycol liposome doxorubicin (PLD) can     go into tumor tissues through tumor angiogenesis and produces targeted killing effect to     tumor tissues. PLD has potential advantages in the treatment of malignant tumors,including     lymphoma.   "
57968|NCT02526810|"     The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and     oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with     oral drugs and the other is continuous subcutaneous insulin injection.   "
57969|NCT02526797|"     To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer     can improve the selection of patients suitable for Active Surveillance and have a relevance     in the ongoing monitoring.   "
57970|NCT02526784|"     The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions)     following degarelix subcutaneous (s.c.) administrations with two different injection     techniques and intramuscular (i.m.) administration in patients with hormone dependent     prostate cancer.   "
57971|NCT02526771|"     The aim of this study is to compare the surgical outcomes of conventional lymph node     dissection with unconventional lymph node dissection during resection of Intrahepatic     cholangiocarcinoma.   "
57972|NCT02526758|"     Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by     progressive development of airflow limitation. Small airway disease (obstructive bronchitis)     and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow limitation.     Research shows that small airway resistance increased by 4-40 times in COPD patients, and     become the main part of the airflow obstruction. Impulse oscillation system (IOS) is able to     measure the total airway resistance, the central airway resistance and the peripheral airway     resistance, which is now widely used to assess small airway function in COPD patients. While     High resolution CT (HRCT) is easy to operate and its images are intuitive. Meanwhile it can     measure the proportion of emphysema, the airway diameter and the thickness of airway wall.     Both of these two tests have great significance in small airway evaluation. Chronic     obstructive pulmonary disease with acute exacerbation (AECOPD) is an acute onset process,     which is characterized by the aggravation of respiratory symptoms and deterioration of     pulmonary function. However, the structural and functional changes of small airway in AECOPD     are not clear. Inhalation drugs are the main treatment for stable COPD , and inhaled     corticosteroid（ICS）+long-acting beta2-agonist（LABA） are used to treat patients with severe     and severe airflow limitation. The particles in traditional inhalation drugs are larger and     mainly deposited in large airways, and their effects on small airway function are relatively     small.      The objectives of the investigators study are COPD patients. The study is divided into two     parts, that is the part of AECOPD patients and the part of stable patients . Patients with     AECOPD are arranged to take HRCT and IOS test to assess the small airway changes.Patients     with stable COPD are randomized to take either beclomethasone / formoterol (particle diameter     for 1.4-1.5um) or budesonide / formoterol (3.2um) for three months. The structure and     function changes of small airway in different stage will be evaluated and the efficacy of     these two drugs is to be compared. This study is expected to highlight the investigators     understanding on the role of small airways in COPD, and provide a guideline to clinical     standardized treatment as well as evaluation of patients' conditions.   "
57973|NCT02526745|"     This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged     50 years and older. Half of participants will receive high doses of the vaccine,while the     other half will receive low doses of the vaccine in phase I clinical trial. At the phase II     clinical trial, participants will be distributed equally to four groups(low、middle, high     doses of the vaccine and placebo).   "
57974|NCT02526732|"     The aim of the study is to examine the influence of hepatic inflammation or damage on     physical performance (maximal oxygen uptake, VO2max) depending on the histologic state of the     liver. The study population are patients with fatty liver disease and non-alcoholic     steatohepatitis (NASH). All study participants obtain an individual training plan with     individual and group training sessions for a period of 8 weeks. At the beginning and end of     the training phase a sport physiological examination is carried out. In the study group the     effect of regular examinations is surveyed by surrogate parameters of liver inflammation.   "
57975|NCT02526719|"     The goal of nipple-sparing mastectomy (NSM) with immediate breast reconstruction is to     reconstruct a breast mound with preservation a patient's natural skin envelope. Preservation     of the nipple and areola complex during mastectomy and breast reconstruction is associated     with improved quality of life and a better cosmetic result. However, this surgical technique     relies on tenuous blood supply to maintain the nipple and areola. Therefore a certain     proportion of women will actually lose their preserved nipple-areolar complex due to vascular     insufficiency. Furthermore, some women may find out after a nipple-sparing mastectomy that     cancer had invaded the nipple-areolar complex, and would require another operation to     completely remove the cancer. Despite these devastating complications, there have been no     controlled studies to investigate mechanisms to reduce the chance of their occurrence.      Our research study will use a pre-operative minor procedure to enhance blood flow to the     nipple-areola complex prior to standard nipple sparing mastectomy among eligible women     undergoing mastectomy for breast cancer or risk reduction. A secondary objective is to test     how many women actually have active cancer in their nipple at the time of this minor surgical     procedure, prior to standard NSM. The investigators hypothesize that our innovative and novel     nipple-delay procedure will reduce the risk of loss of the nipple due to vascular     insufficiency and may be of benefit to identify the small proportion of women with     nipple-areola complex involvement, in order to optimize the ultimate cancer ablation.      For this study the investigators propose to undertake a Pilot RCT as the first step in the     evaluation of a delay procedure prior to NSM, and the results will be used to determine the     feasibility and inform the optimal design for a definitive RCT. This study question has the     potential to set a new standard of care in the management of women seeking NSM for the     management of their breast cancer.   "
57976|NCT02526706|"     The investigators aim to conduct a prospective clinical pilot study to investigate the use of     VisionBlue staining administered during cataract surgery to 20 patients with history of     trabeculectomy for glaucoma as a means to assess functioning of an existing filtering bleb.     The investigators also aim to develop a standard classification system for assessing     filtering bleb function during cataract surgery.   "
57977|NCT02526693|"     The Konan RAPDx (Konan Medical USA, Irvine, CA) is a newly patented pupillography device.The     aims of this study are to assess the ability of the RAPDx to distinguish between healthy     subjects and patients with confirmed glaucoma using standard testing sequences, assess the     ability of the RAPDx to distinguish between healthy subjects and patients with confirmed     glaucoma using a customized testing sequence developed for use at the Wills Eye Hospital     Glaucoma Research Center and to determine the combination of demographic, clinical, and RAPDx     testing parameters which allow for maximum sensitivity and specificity in discriminating     healthy subjects from those with glaucoma.   "
57978|NCT02526680|"     To determine the impact of OrCam on health-related quality of life (HRQoL) in subjects with     advanced glaucoma over 1 month and to assess health-related quality of life using the     National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25).      To determine the tasks for which the subjects are using the OrCam device and patient     satisfaction and to analyze qualitative data from weekly patient logs, in order to determine     efficacy of OrCam.   "
57979|NCT02526667|"     Demonstrate the reduction of bacteria on the skin.   "
57980|NCT02526654|"     The main purpose of this study is to compare standard automated perimetry (SAP) using the     Heidelberg Edge Perimeter (HEP) with the Octopus Visual Field (OVF) analyzer and determine     test-retest reliability of both parameters in detecting glaucomatous visual field losses. A     secondary outcome measure is investigation of novel imaging parameters of the optic nerve     head and a new automated structure-function report.   "
57981|NCT02526641|"     Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of     chronic viral hepatitis C infection on the macrophage specific activation marker soluble     CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and     metabolic liver function determined by the galactose elimination capacity (GEC) test and the     functional hepatic nitrogen clearance (FHNC).   "
57982|NCT02526628|"     The haemostatic balance and neurocognitive capability of men with Klinefelter syndrome is     compared to healthy controls by using specific biochemical assays for coagulation and     fibrinolysis and a selection of neuropsychological tests and brain fMRI. Furthermore, the     effect of gonadal status and any effects of long- or short-term testosterone treatment on the     above mentioned parameters are investigated.   "
57983|NCT02526615|"     The objectives of this study are to compare the effects of rosiglitazone and metformin on     insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal     muscle, heart and adipose tissue insulin stimulated glucose uptake is measured during     euglycemic hyperinsulinemic clamp and positron-emission tomography scanning before and 26     weeks after treatment in 48 newly diagnosed subjects with type 2 diabetes. Subjects will be     randomized to receive either rosiglitazone or metformin or placebo, according to a simple     randomization procedure with double blinding.   "
57984|NCT02526602|"     Urinary incontinence and impotence are typical disturbances after radical prostatectomy.     Although, several surgical methods are developed to decrease these disturbances, 8% and 50%     of the patients suffer from permanent urinary incontinence and impotence, respectively.      Previously two studies have shown that endopelvic fascia preservation may decrease     postoperative incontinence and impotence rates. Unfortunately these studies are retrospective     decreasing their reliability.      The present study is prospective and randomized clinical trial. The investigators are going     to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional     and oncological results are followed up to 1 year after surgery.   "
57985|NCT02526589|"     Traditionally the watertightness of urethrovesical anastomosis after robotic radical     prostatectomy is controlled by cystogram. However, clinical observations and one previous     study showed that patients with anastomotic leakage have red coloured urine. If the     investigators can verify this finding, the most of the cystograms can be avoided. In this     study the investigators estimate urine colour after cystogram and take a picture from urine     collecting pag. Later on the pictures are digitally analyzed and compared to cystogram     finding.   "
57986|NCT02526576|"     This phase two, randomized, double-blind study is designed to demonstrate the enhanced     efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF     enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted     region over the course of one year.   "
57989|NCT02526537|"     Currently, whether adjuvant therapy should be applied to Stage Ib non-small cell lung cancer     (NSCLC) patients who received radical resection remains controversial. There is still no     clear evidence that the postoperative adjuvant chemotherapy or other treatments can improve     the survival rate for patients with stage Ib NSCLC. Tyrosine Kinase Inhibitors (TKIs) such as     Gefitinib and Erlotinib are widely accepted as the first-line therapy for Epidermal growth     factor receptor (EGFR) gene mutation late stage NSCLC patients. However the effect is largely     uncertain for early stage patients who received surgery. The investigators aim to evaluate     the effect of postoperative adjuvant use of Gefitinib for high risk stage Ib EGFR sensitive     mutation NSCLC patients.   "
57990|NCT02526524|"     The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met     DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is     designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning [qAM])     compared to placebo. A single-blind reference treatment of 2000 mg metformin     immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID)     will also be included.   "
57991|NCT02526511|"     This pilot clinical trial studies perfusion magnetic resonance imaging in diagnosing patients     with kidney tumors. Diagnostic procedures, such as perfusion magnetic resonance imaging, may     help find and diagnose kidney tumors and predict and monitor a patient's response to     treatment.   "
57992|NCT02526498|"     This phase II trial studies how well accelerated partial breast irradiation (APBI) using     high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not     spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation     therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type     of internal radiation therapy that provides radiation inside the breast to any remaining     tumor cells next to the space where the tumor was removed, and is given over a shorter amount     of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI)     using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is     delivered to the tumor cells.   "
57993|NCT02526485|"     The purpose of this research is to identify genomic markers that can predict heparin-induced     thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly     used to prevent blood clots and the investigators may be able to identify genomic markers     which can be used to prevent heparin use in people who will get HIT.   "
57994|NCT02526472|"     One thousand, six hundred forty-eight IVF patients undergoing ET with fresh embryos,     randomized to receive mTVET (n=828) or UGET (n=820). The transfer in uteri of 1-2 embryos on     day 2-3 of culture was performed using a soft catheter either under trans-abdominal US     guidance (UGET group) or after measurement of uterine cavity by transvaginal US and     calculation of the discharge site (mTVET). Mai outcome measures was the clinical pregnancy     rate (CPR), secondary outcomes were the implantation rate (IR), and the patient's discomfort     during ET procedure.   "
57995|NCT02526459|"     The study design is a prospective, single institution, randomized control trial in which the     introduction of a birth plan is the intervention and a comparison of the rate of Caesarean     sections between participants in the control group (no birth plan) and the experimental group     (birth plan) is the primary outcome.   "
57996|NCT02526446|"     This proposed study is to evaluate the effectiveness of a self-administered acupressure     intervention on caregiver stress and associated distress symptoms of fatigue, insomnia and     depression in Chinese family caregivers of an elderly family member.   "
57997|NCT02526433|"     Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least     75,000 cases per year in the UK alone. However, despite this, there is currently a worrying     lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK     do not have a strategy for treating PND, and flaws in the current pharmacological and     psychological treatment models. Consequently, research into promising psychosocial     interventions such as music is critical to developing new paradigms for treating PND.      This project is an ambitious programme of research that investigates links between the mental     health of women in the later stages of pregnancy and first 9 months post birth and their use     of psychosocial interventions including music.   "
57998|NCT02526420|"     A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for     five months in adults with GHD.   "
57999|NCT02526407|"     Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least     75,000 cases per year in the UK alone. However, despite this, there is currently a worrying     lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK     do not have a strategy for treating postnatal depression, and flaws in the current     pharmacological and psychological treatment models. Consequently, research into promising     psychosocial interventions such as music is critical to developing new paradigms for treating     postnatal depression.      This project is an ambitious programme of research that investigates the effects of music on     postnatal depression through two phases: a questionnaire study and an intervention study.     This record is for the intervention study. The questionnaire study has a separate record. We     are accepting host hospital sites for both.   "
58000|NCT02526394|"     The trial includes groups receiving various combinations of meningitis C and pertussis     containing vaccines, to be administered concomitantly in adolescents due their school leaving     booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age).     Immunogenicity and reactogenicity will be assessed.   "
58001|NCT02526381|"     Clinical study on patients with turbid phlegm and blood stasis syndrome and Qi -Yin     Deficiency syndrome of coronary artery disease (CHD) compared with normal cases will be     launched. Detection of lipid metabolism, inflammation medium, endothelial cell injury, blood     coagulation function evaluation of the relationship between disease and biochemical basis,     detect plasma metabonomics and the gene expression profile chip, with phlegm - lipid     metabolic disorder, stasis - microcirculation disorder, alternating knot - inflammation     mediated and other system related to the biological basis. With Danlou Tablet for treatment,     the investigators can observe result/effect index of turbid phlegm and blood stasis syndrome.     Through comprehensive comparison of multi-level, multi-targets and multi-date biological     index to discuss its sickness-syndrome-prescription corresponding relation and its biological     basis.   "
58003|NCT02526355|"     The prevalence rate of postnatal depression in Pakistani women and its effect on the growth     and development of young children and child mortality is very high.      The main objective of this study is to increase access to evidence based psychological     interventions for mothers who have children of age 0 to 12 months, consistent with her     values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled     trail. Depressed mothers will be randomized either to intervention arm or control arm.     Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).   "
58004|NCT02526342|"     Aim of the study is to prove the utility and safety of the negative pressure wound therapy     (NPWT) in the postoperative management of free flaps.      The quantitative assessment of the entirety of clinical main relevant parameters like edema     formation, microcirculation, macrocirculation and wound healing should create a better and     comprehensive understanding of the NPWT effects in this field.   "
58005|NCT02526329|"     This phase I trial studies the side effects and best dose of donor regulatory T cells in     treating patients with graft-versus-host disease affecting the liver or gastrointestinal     organs (visceral) within 100 days (acute) after undergoing a stem cell transplant.     Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant     attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a     type of immune cell that may be able to reduce the attack of the donor's immune cells on the     patient's normal cells and help treat graft-vs-host disease.   "
58006|NCT02526316|"     The study will include 10 patients with HPV-associated ano-genital cancer (cervical, vulvar,     vaginal, penile, anal) or HPV-associated head and neck cancer, who are planned to receive a     cisplatin-based chemotherapy (alternatively a carboplatin-based chemotherapy may be selected     by investigators choice). Patients will receive P16_37-63 peptide (100 µg) combined with     Montanide® ISA-51 VG subcutaneously once a week for four weeks, followed by a 4 week rest     period (1 cycle). The vaccination is to be started one week before the initiation or     continuation of the cisplatin-based chemotherapy. Concurrent radiation is allowed and should     be documented. The vaccination schedule will be repeated up to a total of 3 cycles (= 6     months) or until progression or intolerable toxicity. If chemotherapy is withheld (e.g. for     toxicity), vaccination treatment can be continued.   "
58007|NCT02526303|"     The purpose of this study is to determine the safety and efficacy of anticoagulation in the     treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.   "
58008|NCT02526290|"     In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal     Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be     evaluated.   "
58009|NCT02526277|"     The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy     may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the     MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS.     Participants will be randomly assigned to one of four treatment groups;        1. MMF07 Foot Massager device        2. Heat therapy        3. Heat therapy and the MMF07 Foot Massage device        4. Neither heat nor MMF07 Foot Massager device (no treatment group)   "
58010|NCT02526264|"     Patients with colorectal cancer prior to stoma surgery are randomized to different     preoperative education programs: (a) specific preoperative education, (b) standard     preoperative education. Outcome measures are quality of life, period of hospitalization and     complication rates.   "
58011|NCT02526251|"     The purpose of this cohort study is to map, during one year in an e-health setting, patients     having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to     dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires     (HBI and SCCAI) and Fecal Calprotectin (FC) on any smart phone. And Secondarily how dysbiosis     defined by a dysbiosis index (DI) ranging from 1-5 is related to changes in disease activity     and FC under different treatments scenarios. Is a certain DI or specific bacteria probes     related to increase or reduced relapse rate. Moreover change in above mentioned     parameters/indices will also be correlated to QoL and a fatigue score.   "
58012|NCT02526238|"     This is a double blinded, randomized control trial with a pretest-posttest control and     interventional group design. The assessor is blinded to all assessments and evaluations. All     patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened     initially by a series of screening test. Suitable patients are assigned randomly to two     groups respectively. Group 1 is the experimental group for Transcranial Magnetic Stimulation     (TMS) and trunk rotation; Group 2 is the control group with only trunk rotation training and     placebo stimulation.   "
58013|NCT02526225|"     The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone     meglumine injection tn the treatment of acute ischemic stroke   "
58014|NCT02526212|"     The primary goal of this research is to improve the effectiveness of buprenorphine     maintenance treatment (BMT) within primary care.      Investigators propose that providing BMT as part of a group medical visit (instead of an     individual visit) will improve treatment outcomes for patients with persistent opioid abuse,     because members become accountable to the group, are exposed to beneficial habits of others     (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly     with medical management   "
58015|NCT02526199|"     To extend the duration of peripheral nerve blockade after major foot and ankle surgery the     investigators randomize the postoperative treatment with either perineurial sciatic nerve     blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.   "
58016|NCT02526186|"     We will conduct a randomized controlled trial to determine whether the addition of     battlefield auricular acupuncture to standard of care is effective for control of postpartum     pain for mothers in the immediate post-partum period. Post-partum patients (DoD     beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth     in a hospital setting will be offered the opportunity to participate in the study through PCM     referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24     hours post caesarean section subjects will be given treatment according to their     randomization group. Subjects will be assessed on pain control, overall satisfaction with     pain management, and the amount of pharmacological pain medications used. Safety of measures     will also be assessed to include infection rates, syncope, vertigo, and hypotension.   "
58018|NCT02526160|"     UX023-CL303 is a phase 3 multicenter, randomized, double-blind, placebo-controlled study to     evaluate the efficacy and safety of KRN23 in adult subjects with XLH. Approximately 120     subjects with a diagnosis of XLH supported by clinical and biochemical features consistent     with XLH and/or a confirmed PHEX mutation (self or family member consistent with X-linked     inheritance) and with bone or joint pain at baseline will be enrolled. Subjects not receiving     supplementation therapy with oral phosphate and active vitamin D metabolites or those willing     to discontinue supplementation therapy are eligible.   "
58019|NCT02526147|"     This evaluation is part of a five country project to evaluate the benefits and costs of the     use of two alternatives to food transfers: vouchers and cash (hereafter referred to as     alternative modalities). The project will generate information on how outcomes such as     household food expenditure and dietary diversity, relevant to both beneficiaries and WFP,     change following the introduction of these alternative modalities; how benefits and costs of     these are, relative to food transfers, distributed across and within households; and what are     the critical operational issues that need to be addressed for these alternatives to be     successfully implemented. More specifically, the project will answer seven questions:        1. Do households benefit from receipt of the alternative modalities?        2. Are these benefits greater, or less, when transfers are made using alternative          modalities compared to food transfers. How does this vary across outcomes (such as          nutrition, livelihoods, gender dynamics and intra-household resource allocation) that          are of especial interest to WFP?        3. How does the distribution of benefits differ across households when transfers are made          using alternative modalities compared to food transfers?        4. How does the distribution of benefits differ within households when transfers are made          using alternative modalities compared to food transfers? Do certain household members          (women, young children) benefit more from one type of modality? How do these modalities          affect decision-making processes within the household?        5. Why are these differences observed? How do the reasons for these differences affect the          study's ability to generalize from these evaluations?        6. Does the delivery of alternative modalities cost less than food transfers? What accounts          for these cost differences? Are some costs (such as transport) really lower or are they          transferred to beneficiaries? Within the household, who bears these additional costs?        7. What is the benefit: cost ratios associated with these different modalities from the          perspective of WFP? Is there a conflict between the modality preferred by WFP and the          modality preferred by beneficiaries?      These objectives will be accomplished through household survey data collection among a panel     of households before and after transfer of alternative modalities. In addition, select     countries will involve the collection of anthropometric, biomarker and cognitive testing.   "
58020|NCT02526134|"     The purpose of this study is to estimate the rate of patients in whom a significant change in     the area to be irradiated will be observed between the assessment before and after laying the     evaluation of Trustees.   "
58021|NCT02526121|"     The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on     blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload,     compared with a dietary intervention alone.      All subjects in this study will follow dietary and lifestyle counseling in a period of 3     months.      A randomized group will receive phlebotomies every 3 weeks in this period.   "
58022|NCT02526108|"     The purpose of this study is to assess the energy expenditure and intensity of a High     Intensity Functional Training (HIFT) session in overweight and obese adult men and women.   "
58023|NCT02526095|"     This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor     after surgery.   "
58024|NCT02526082|"     The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started     in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention     trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up     through national registers since the 1980, and since 2000 with regular questionnaire surveys.     Latest in 2015. Also clinical and laboratory studies have been performed in random     subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.   "
58025|NCT02526069|"     Study Objectives:      This study aims to assess the feasibility and acceptability of an application utilising     Acceptance and Commitment Therapy in young people with type 1 diabetes.      Primary Research Questions:      Is an ACT based application feasible and acceptable to young people with type 1 diabetes.      Study Design:      Patients will use the app for four weeks and then be invited to attend an interview     discussing the acceptability, usability and feasibility of the app. Clinician's will also be     invited to take part in a workshop where they interact with the app and provide feedback.      Consent for will be obtained through the app. Additional consent for the recording of     interviews will be obtained in paper format and stored in a secure locked cabinet at     Edinburgh University.      Quantitative data will also be collected on well-being, psychological flexibility, and data     usage.      Data Collection      Qualitative feedback:      Interviews will be recorded and transcribed using unique identifiers.      Outcome measures and data usage patterns:      Data will be collected on a password protected database which can only be obtained via a     password protected and encrypted server from University of Edinburgh.      Data Analysis:      Phase 1:      Framework analysis and interpretive phenomenological analysis will be utilised to create     themes from the qualitative feedback.   "
58026|NCT02526056|"     This study is a usability design with qualitative and quantitative aspects. In one part, with     patients, physical strain and designs facets will be investigated and in another part with     physiotherapists, the therapeutic relevance and design features will be explored.      For this reasons 13-15 elderly people have to play an exergame, during their game playing     process, different measurements will be done. Additional 13-15 physiotherapists will also     playing the exergame, they will be asked about their opinions about the game.   "
58027|NCT02526043|"     The purpose of the study is to observe the curative effect and safety of laparoscopic versus     open liver resection for hepatocellular carcinoma.   "
58028|NCT02526030|"     The selection of antipsychotic in early stages of the illness is mainly determined by its     clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug     treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a     homogeneous group and clinical effects and profile of side effects differ between SGAs.     Differences among antipsychotics in terms of effectiveness have turned out to be a topic of     increasing research interest, although comparisons between the different SGAs are scarce. In     first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to     first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less     evident seems to be the notion that some of the SGAs might be more effective (in terms of     treatment discontinuation) than others. Most of the medium-term randomized studies have shown     similar rates of all-cause treatment discontinuation in first episode patients treated with     different SGAs. It may be concluded that more randomized controlled trails should be     accomplished to determine the position of frequently used SGAs in clinical practice.     Investigators undertook this study with the major objective of comparing the clinical     effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in the     acute treatment of first-episode non-affective psychosis individuals at 3 years of follow-up.   "
58030|NCT02526004|"     Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary     use of antibiotics is a key driver in the development of antibiotic resistance. Cystic     Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore     therapeutic strategies for same, as chronic lung infection overlaps with acute lung     exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial infection     develops, with the most dominant infecting organism being Pseudomonas aeruginosa. In acute CF     infections, empiric intravenous antibiotics are usually given for two weeks. Recurrent     infections and treatments result in increasing antimicrobial resistance, and alterations in     pathogen host interactions in the lung and gut flora. Next-generation DNA sequencing     technology now offers DNA-based personalised diagnostics and treatment strategies. Enhancing     our knowledge of the microbiome allows the use of stratified targeted antibacterial therapy     that can be compared with standard empirical antibacterial therapy currently used. Cystic     Fibrosis Microbiome-determined Antimicrobial Therapy Trial in Exacerbations: Results     Stratified (CFMATTERS) will provide a randomized multi-centre controlled trial of     microbiome-derived antimicrobial treatments versus current empirical therapy.   "
58031|NCT02525991|"     Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in     Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile     of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when     self-administered outside of a hospital setting without the supervision of a healthcare     professional. The Study will aim to include approximately 500 patients who have been     previously treated with ADASUVE® in the last 6 months prior to screening or recently treated     during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE®     responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about     30-34 centers. All patients will be followed up for a maximum of 6 months from baseline,     during which it is expected that a new episode of agitation will occur.   "
58032|NCT02525978|"     The purpose of this study is to understand if there is a relationship between the way that     emotions are regulated by the brain and the way that heart rate is regulated by the brain.     The study also seeks to understand whether having depression changes the way that emotions     and heart rate are regulated.   "
58033|NCT02525965|"     Before the surgery, the investigators predict the risk of microvascular invasion (MVI)     presence for the early-stage hepatocellular carcinoma according to the nomogram the     investigators have created. Patients with a high risk of microvascular invasion were randomly     chose to give the treatment of a wide resection margin, which establish an individualized     anti-recurrence program based on the high-grade evidence-based medicine.   "
58034|NCT02525952|"     The aim of this study is to establish a selection criteria of hepatectomy for patients with     multiple hepatocellular carcinomas based on the NDR Scoring System   "
58035|NCT02525939|"     A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study     in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects     will provide informed consent before any study-specific procedures are performed. Subject     enrollment may begin in the hospital and will continue following release from the hospital.     Screening procedures may be performed at the time of the index ACS event or anytime     thereafter, with the condition that randomization must occur within the mandated window (4-12     weeks after the index event). Subjects will be assessed based on their medical history. Those     who are likely to qualify will undergo Genotype Assay testing to evaluate genetic     determination for the presence of AA genotype.   "
58036|NCT02525926|"     Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and     premature death. Only modest improvements of outcomes have been observed with the current     available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also     expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot     study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical     improvement in 13 patients with severe pulmonary hypertension despite optimal medical     management. However this single non-randomized study requires confirmation.      The investigators propose a prospective multi-center, randomized, single-blinded trial. Its     main objective will be to assess, in patients with uncontrolled pulmonary hypertension     despite optimal medical management, the efficacy of pulmonary artery denervation in reducing     mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment     following a simulated (sham) procedure.      The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right     heart catheterization.      The study will run for 18 months and it will be necessary to recruit 50 patients.      All adult patients (with the exception of pregnant women and individuals unable to receive an     appropriate information and to give their free and informed consent) with uncontrolled     pulmonary arterial hypertension despite optimal medical management will be invited to     participate, in the absence of any exclusion criteria.      The investigators will also measure changes in clinical, biological, echocardiographic and     hemodynamic prognostic markers in both groups.   "
58037|NCT02525913|"     The purpose of this study is to build a device that will consistently ablate (destroy or     remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the     tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to     handle, perform the ablation in less time and by so ablating this margin would avoid the need     in many for reoperation to obtain negative margins and based on preliminary data avoid the     need for radiation. This would be especially important in poor and rural patients and would     lead to decreased costs of treatment in patients with favorable breast cancer.   "
58038|NCT02525900|"     Prospective, randomized study comparing local wound infiltration with local anesthetic (LA)     versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths)     catheters with LA for treatment of postoperative pain after total abdominal hysterectomy     (TAH).   "
58039|NCT02525887|"     This observation will look at patient care decisions of the primary healthcare provider     utilizing the results of the DNA testing of patients' metabolic pathways using 2C19, 2C9,     2D6, 3A4, Factor II, Factor V and MTHFR and VKORC1. Findings of the data collection will be     published to optimize the benefits of pharmacogenomics testing and publish health outcomes.   "
63366|NCT02456233|"     This prospective randomized study will assess the safety and efficacy of FIRM-guided ablation     (FIRM+PVI) compared to pulmonary vein isolation (PVI) without FIRM, for the treatment of     symptomatic atrial fibrillation.   "
58041|NCT02525861|"     The purpose of the study is two-fold: (1) to further evaluate the safety and potential     immunogenicity of GLASSIA following IV administration via in-line filtration; and, (2) to     assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various     biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration at     a dosage of 60 mg/kg Body weight (BW)/week active A1PI protein for 25 weeks in subjects with     emphysema due to congenital A1PI deficiency.   "
58042|NCT02525848|"     To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin     prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic     gynacological surgeries.   "
58043|NCT02525835|"     This pilot study will test the hypothesis that a low sodium diet will decrease sodium (23Na)     magnetic resonance imaging-determined skin sodium concentrations in patients with systemic     lupus erythematosus (SLE) and improve blood pressure and inflammation   "
58044|NCT02525822|"     The primary objective of this study is to compare the safety and efficacy of once daily     application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in     subjects with moderate to severe acne vulgaris.   "
58045|NCT02525809|"     The total hip replacement, with over 120,000 cases per year in France, provides short term,     excellent functional results and a significant improvement in quality of life, in almost all     cases. However, observation showed that the dislocation is not a rare complication (2-4%) and     the lifetime of the implants is limited due to aseptic loosening.      The evaluation process used in this study will be the extent of penetration of the metal     femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA)     whose precision provides early results (2 3 years), long before wear and migration are     measurable by conventional radiological means. The main objective will be to compare, 2 years     after the intervention, the penetration of the metal femoral head in 3 types of inserts: two     dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure     (Sunfit®), and a fixed insert (Quartz®).      This is a randomized controlled trial. 105 patients will be enrolled (35 in each group).     Patients will be included in each of the two participating centers (Amiens, Caen). The     analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will     be made to 3 years if the analysis requires it to 2 years.      Analysis of pictures will be centralized in Caen and performed with specific software after     transferring images via a secure network.   "
58046|NCT02525796|"     This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in     combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium     levels in primary hyperparathyroidism.   "
58047|NCT02525770|"     Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the     few early complications (acute infections and dislocations), the patient made a PTH can be     assured of a significant improvement in its function and its short-term quality of life.     However, clinical studies and records have shown that the lifetime of these implants was     limited. The main cause of failure is the aseptic loosening influenced by many factors,     foremost of which is due to periprosthetic osteolysis debris. This is a major concern for     orthopedic surgeons loosening leads, in most cases, the recovery, the importance of     osteolysis is a major cause of difficulties and poorer results.      The main objective of the study is to compare, 2 years after the intervention, the     penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC®     conventional polyethylene.   "
58048|NCT02525757|"     The goal of this clinical research study is to learn about the safety of adding MDPL3280A to     standard chemotherapy (a combination of carboplatin and paclitaxel) and radiation in patients     with lung cancer.      You are being asked to take part in this study because you have non-small cell lung cancer     (NSCLC) that is unresectable (cannot be removed by surgery) and has not spread.   "
58049|NCT02525744|"     This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is     administered by injection under the skin of the abdomen. The study will be conducted in     healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of     different doses of LY900014 on blood sugar levels. Side effects and tolerability will be     documented. The study will last for about 8 to 9 weeks for each participant, including     screening and follow up. Screening is required within 28 days prior to entering the study.   "
58050|NCT02525731|"     The TEACH patient cohort will characterize a clinic sample of HIV-infected patients on     chronic opioid therapy (COT) by describing basic demographics and health status, including     characteristics of pain (severity and interference), aberrant behaviors/misuse of COT,     substance use and trust/satisfaction with providers. In addition, data on a subset of     participants will be used to supplement analysis of secondary outcomes for the TEACH     randomized controlled trial (RCT), an intervention study directed at COT providers (outlined     in a separate Clinical Trials Protocol Registration and Results (PRS) summary).   "
58051|NCT02525718|"     Subjects are being asked to participate in this study because they will be undergoing     unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction     involving insertion of a tissue expander.   "
58052|NCT02525705|"     The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping     syndrome in children operated at birth for oesophageal atresia type III et IV.   "
58053|NCT02525692|"     ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory     studies and completed a phase I clinical trial in advanced cancer patients. This clinical     trial will be the first phase II clinical trial of ONC201 that will specifically enroll     patients with advanced glioblastoma.   "
58054|NCT02525679|"     The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy     male subjects following single rising low, medium and high doses.   "
58055|NCT02525666|"     Investigation of a bilateral inguinal hernia repair using one large self-fixating mesh     covering both groins. Health outcomes are assessed using different questionaires with focus     on urinary symptoms (with ICIQ-MLUTS score), the recurrence rate, postoperative pain     measurement, and Quality of Life assessment with EuraHS-QoL and chronic pain monitoring for     12 months.   "
58070|NCT02525471|"     The purpose of this study is to determine the safety and tolerability of RNS60 in patients     with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60     on several markers of neuro-inflammation, measured by blood biomarkers and positron emission     tomography (PET) imaging.   "
58056|NCT02525653|"     The purpose of this study is to test the safety and effectiveness of albumin-bound paclitaxel     plus gemcitabine in patients with advanced squamous cell lung cancers. The investigators     would like to determine the percentage of patients with squamous cell lung cancers who     experience shrinkage of their tumors following treatment with this regimen. This combination     of drugs is not a standard therapy for patients with squamous cell lung cancers. However,     each of these drugs, when given alone or with other chemotherapies, is FDA-approved for the     treatment of this disease.   "
58057|NCT02525640|"     Single sided deafness (SSD) refers to asymmetrical hearing loss, where there is a significant     worsening of hearing in one ear compared to the other.      In Cambridge, the investigators see large numbers of patients with SSD caused by vestibular     schwannomas, due to their affiliation with the Neuro-Otology Department, with over 100 new     SSD patients being referred every year.      Only a small number of studies have explored hearing handicap for those with SSD, and music     appreciation has not been investigated, to the best of the investigators knowledge, in this     patient group.      In the limited number of studies conducted on those with single sided deafness, often only     one or two outcome measures have been used, or the patient group has been small. The     investigators have a large group of patients with a wide range of aetiologies who have     completed several questionnaires as part of their treatment in the single sided deafness     clinic and the investigators would like to analyse these data.      At present there are different devices available on the NHS for the management of SSD and     many studies have explored benefits of Bone Anchored Hearing Aids (BAHA). There is an     under-representation of studies looking specifically at CROS aid devices which is relevant     given the cost differences involved between devices.      Study goals and objectives        -  To find out what factors drive hearing handicap in SSD patients by analysing the results          of several different well validated hearing handicap questionnaires        -  To find out whether or not it is possible to change hearing handicap in this patient          group by looking to see if there is an improvement in questionnaire scores post          treatment.        -  The investigators will also look at a sub-group who will be fitted with both traditional          wired CROS aids and more up-to-date wireless aids which have been funded through a          research grant, in order to assess whether these are more beneficial.        -  The investigators will use a new questionnaire developed in-house to further explore the          impact of single sided deafness on music appreciation.   "
58058|NCT02525627|"     Prospective, singlecentre, randomized clinical study; series of patients with a 5-years     patient evaluation period.   "
58059|NCT02525614|"     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective     randomized clinical trial.   "
58060|NCT02525601|"     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective     randomized clinical trial.   "
58061|NCT02525588|"     Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with X3 highly     cross-linked polyethylene in a CS (condylar stabilizing) fixed bearing total knee prosthesis     by means of RSA and clinical evaluation.   "
58062|NCT02525575|"     For suicidal individuals, minimizing future risk and fostering recovery are critical public     health concerns, especially among Veterans, as very few effective interventions exist. This     proposal tests a novel group psychotherapy treatment that combines emotion regulation skill     based, and psychoeducational approaches, with suicide safety planning development and     implementation.      Project Life Force (PLF), a novel suicide safety planning group intervention has been     designed to fill this critical gap and provide a mechanism to develop and enhance suicide     safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines     Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance     suicide safety planning development and implementation. Veterans revise their plans over     several weeks while learning distress tolerance, emotion regulation, and friendship     building/interpersonal skills to incorporate into their safety plans and also receive lessons     on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training     in the use of a suicide safety planning mobile App to promote accessibility and maximize     implementation, and 2) didactic information to bolster recovery, including fostering improved     connection with the treatment team, and Veteran's family.   "
58063|NCT02525562|"     Provide outcomes information with regard to surgical and implant performance and patient     clinical outcomes of the patients who are eligible for either a Total Knee Arthroplasty (TKA)     replacement surgery or Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA)   "
58064|NCT02525549|"     The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to     an FDA approved product for the treatment acne vulgaris.   "
58065|NCT02525536|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK)     profile of trebananib (AMG 386) after intravenous administration in adult Japanese     participants with advanced solid tumors.   "
58066|NCT02525523|"     A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic     antibiotic refractory pouchitis.      Subjects will undertake a <2 week screening period to provide baseline data and be assessed     for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1     basis to either a) 240 mg alicaforsen enema or b) matching placebo.      Study drug will be administered once nightly (on going to bed) up to and including week 6.     Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy     assessments at Week 3, 6, 10, 18 and 26.      Subjects may receive certain permitted medications as per Entry Criteria, which must remain     at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a     dose change to an existing concomitant medication for pouchitis, other than those detailed in     the protocol, will not be permitted.      Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary     card.      Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6     and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample     for histopathology.      In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will     be assessed.      Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods     and stool samples will be collected to evaluate relevant biomarkers.   "
58067|NCT02525510|"     To protect kidney function during the transplantation process by comparing mild hypothermia     in the deceased organ donor before organs are recovered and pulsatile perfusion of the kidney     after recovery and prior to transplantation.   "
58068|NCT02525497|"     This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis     machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a     domestic peritoneal dialysis machine.   "
58069|NCT02525484|"     This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose,     crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after     administration of tablet and capsule dosage forms under both fed and fasted conditions.   "
58071|NCT02525458|"     One of the major challenges in orthodontic treatment is long-term stability. Because     removable retainers are worn for at least one year, bacteria and fungi may accumulate on the     retainers in the form of multi-species plaque biofilms. This may result in increased     incidence of proximal dental caries or oral candida infection. Thus, incorporation of     antimicrobial activity in orthodontic acrylic resin to achieve plaque biofilm reduction is     highly desirable. An antimicrobial and antifungal quaternary ammonium methacryloxy silicate     molecule (QAMS) has been synthesized by sol-gel reaction and incorporated into orthodontic     acrylic resin. The QAMS-copolymerized acrylic resin demonstrated contact-killing properties     against single-species biofilms in previous in vitro studies and has received US FDA 510(K)     clearance for marketing. The objective of the present randomized clinical trial is to     determine the in vivo antimicrobial efficacy of the QAMS-containing orthodontic acrylic by     using removable retainers that are worn by recruited subjects to create 48-hour multi-species     plaque biofilms. The null hypothesis tested is that there is no difference in the     antimicrobial activities between QAMS-free and QAMS-containing orthodontic acrylic resin on     oral biofilms grown in vivo in human subjects.   "
58072|NCT02525445|"     The purpose of this study is to investigate if it is possible to influence the participants'     expectations to improve outcome, in this particular setting the relaxing effects of one     single acupuncture treatment with genuine or sham needles combined with positive or neutral     communication regarding expected relaxing effects.   "
58073|NCT02525432|"     The purpose of this study is to determine the effect of intravenous infusion of autologous     bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional     outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to     determine if the intravenous infusion of autologous BMMNC after severe TBI results in     structural preservation of global gray matter (GM) volume and white matter (WM) volume and     integrity; as well as select regions of interest in the corpus callosum. THe secondary     objectives are to determine if autologous BMMNC infusion improves functional and     neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI;     evaluate spleen size and splenic blood flow over time using ultrasound and corresponding     changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up     safety evaluations.   "
58074|NCT02525419|"     This study systematically quantified the effects of intermittent fasting and caloric     restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat     mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate     utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were     enrolled in the study as a single cohort and participated in an 12-week trial consisting of     two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2)     11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to     maintain their body weight by consuming their normal food intake; however, during the 11 week     IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of     body weight loss per week. At the conclusion of the 12 week weight loss study, all 40     participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they     agreed to participate, groups were balanced so there were similar numbers of men and women     and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a     modified version of the 12 week weight loss intervention that consumes whole foods along with     2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the     Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n=     18) and asked to follow these nutritional guidelines ad libitum for the duration of 12     months.   "
58075|NCT02525406|"     The goal of the study is to identify factors that enhance productivity and increase value     delivered by hospitals drawing on concepts used in industry for quality and productivity in     production and operations management literature. The investigators intend to look at surgeon     experience, patient characteristics and pre-admission testing on operating room productivity.   "
58076|NCT02525393|"     Patients were randomized in 3 groups: two intervent groups and a control group. The first     group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation     (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct     Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS     and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily     session of sham tDCS.      Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were     performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all     patients underwent follow-up neuropsychological assessment 6 months after the end of each     stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of     each stimulation period.   "
58077|NCT02525380|"     Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced     hepatocellular carcinoma.   "
58078|NCT02525367|"     In Parkinson's disease, Multiple Sclerosis and depressed patients treated with     electroconvulsive therapy, cognitive dysfunction is prevalent. However, treatment of these     dysfunctions is in its infancy.      The purpose of this study is 1) to assess the feasibility of a randomized controlled trial     using an online computerized intervention for training cognitive abilities in the three     patient groups and 2) to estimate the effect of the online training on objectively and     subjectively measured cognitive functions.      The investigators hypothesize that patients using online cognitive training will improve more     on cognitive functions, as compared to patients using an active control condition.   "
58079|NCT02525354|"     Epidemiological studies have shown obesity to be a risk factor of asthma. Research evidence     of obesity and atopic(ie. allergic)-related respiratory diseases, has been less clear. The     purpose of the present study was to test the hypothesis that the relationship between obesity     and atopic-related respiratory disease in premenopausal women is mediated by a dietary     imbalance of omega 6 and 3 polyunsaturated fatty acids.   "
58080|NCT02525341|"     The purpose of the study is to examine the short and long term effects of Hatha yoga compared     to the current recommended exercise program in promoting physical function, alleviating     osteoarthritis (OA)-related symptoms, fear of falling, and improving mood, spiritual health,     physical activity level, and quality of life in older adults with knee OA, and to determine     the effect sizes for use in power calculations to design a larger efficacy clinical trial.   "
58081|NCT02525328|"     Constitutional thinness (CT) is a recently defined entity as a differential diagnosis of     anorexia nervosa (AN), considered to be the most frequent cause of low body mass index (BMI)     in young women. CT subjects present no AN psychiatric traits, preserved menses, no biological     signs of undernutrition and balanced energy metabolism despite a Body Mass Index (BMI) <17 kg     / m².      CT familial aggregation, low body mass without a hormonal explanation, and specific appetite     regulation profile suggest a specific genetic profile in these subjects.      Objective: A family linkage study in order to identify genes involved in the constitutional     thinness phenotype by using genome wide scan (GWAS) techniques Studied population: Fifty     families including at least one well phenotyped CT index case (grade 2 or 3 of thinness     according WHO classification). Blood or saliva is sampled for DNA extraction.      Perspectives: Revealing eventual abnormalities could lead to a more precise diagnosis of     constitutional thinness and new hypothesis in understanding extreme bodyweight mechanisms.   "
58082|NCT02525315|"     Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating.     Behavioral disorders associated with them can have serious social repercussions. However, in     25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.      Fifteen subjects will be included after collection and signed their informed consent.      The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency     of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay     below the risk of occurrence of seizures, the only serious side effects identified.     Furthermore the rTMS treatment is almost painless: tension headaches are the main side     effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The     LEFT stimulation site will be established through a anatomofunctional imaging before     treatment (between D-7 and D0).      Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the     first 2 weeks of starting treatment.   "
58083|NCT02525302|"     This study, HALO-DMD-03, is a follow-on study to HALO-DMD-01 and HALO-DMD-02, and allows     continued open-label access to HT-100 for subjects who have completed these studies.     HALO-DMD-03 will provide safety and strength and function data on continuous long-term     dosing. Data from this study will be used to inform the safety, tolerability, and dose     selection for a future trial of HT-100 in boys with Duchenne Muscular Dystrophy (DMD).   "
58084|NCT02525289|"     To investigate different strategies of body positioning associated to early corporal     mobilization and verify the impact int the time and quantification of thoracic and     mediastinal drainage, pulmonary complications and time of intensive care units in hospitals     stay. After first six hours post extubation in the first postoperative day and after     evaluation and inclusion in the study, patients were randomized in three groups for receiving     different strategies of body positioning associated to early mobilization with help of bed     Hill Rom (Hill Rom Batesville@): Group 1: Control (GC n=33); Group 2: Continuous Lateral     Rotation Group (TRCL n=34); Group 3:Positioning in sitting and Orthostatic (ORT n=34).   "
58085|NCT02525276|"     The main objective of this study is to investigate the role of female sex hormones in     relation to insulin resistance in a controlled human experimental model of menopause and to     explore whether exercise and/or hormone treatment (HT) can compensate for loss of endogenous     sex hormone production by maintaining insulin sensitivity and metabolic activity at a level     equivalent to what is seen in premenopausal women.      Loss of ovarian function is associated with an increased incidence of metabolic disease     including metabolic syndrome, type 2 diabetes and cardiovascular disease. This increased     disease incidence seems to be related to changes in body composition including decreased     skeletal muscle mass and increased visceral fat mass as well as decreased whole body fat     oxidation and energy expenditure. Regular physical activity decreases general mortality among     other things by increasing fat free mass and insulin sensitivity and hereby prevents     metabolic syndrome and cardiovascular disease - conditions seen with an increased incidence     after menopause and could therefore be a possible treatment.      In the present study the Investigators will assess the role of sex hormones in a model of     menopause where healthy women are undergoing planned bilateral oophorectomy due to risk of     hereditary ovary cancer. The use of this model makes it possible to control the time point     for loss of ovarian function and hereby investigate the timeframe and possible contributing     factors in a strictly controlled model. 48 premenopausal women will be included in the study.     The study is conducted in women who have already been offered surgical oophorectomy. The     first 2 months the study will be an observational cohort study. Hereafter the patients will     be allocated to one of four groups (n=12) in a randomized controlled trial, addressing the     effects of 6 months of exercise with or without HT. Type of surgery has been decided before     inclusion based on medical indications. The women will be offered HT according to national     guidelines, but the choice is up to them. Randomization applies only to the training     intervention.      Firstly the Investigators aim at investigating the role of endogenous female sex hormones and     HT in relation to insulin resistance, whole body fat oxidation and -energy expenditure,     changes in visceral fat mass and fat free mass after oophorectomy. Secondly, the     Investigators wish to study the molecular mechanisms behind the oophorectomy-induced insulin     resistance with a focus on insulin signaling in skeletal muscle and fat tissue. Lastly, the     investigators aim to explore whether exercise and/or HT can compensate for loss of endogenous     female sex hormone production by maintaining IS and metabolic activity, hereby preventing     future incidents of metabolic disease in relation to menopause.      All in all, this project will contribute with new knowledge concerning the question of how     endogenous female sex hormones affect insulin sensitivity and metabolic functioning and how     exercise may be used as a disease preventive modality for middle-aged women.   "
58086|NCT02525263|"     A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in     Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from     expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. All     enrolled subjects will be treated with up to two injections of NKA at least 6 months apart.   "
58087|NCT02525250|"     This project is a framework for developing new therapeutic strategies for acute myeloid     leukemia(AML)based immunotherapy.      the role of NK cells was demonstrated in AML and especially GVL effect (graft versus     leukemia) during allogeneic transplantation in these patients. However, it has been shown     that the phenotype of NK cells and their cytotoxic functions were altered during this     malignancy. In addition, in these patients, impaired NK function is associated with relapse.      lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a     role in leukemic cells in this malignancy? what is its effect on the production of     pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of     NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the     cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in     the production of TNF-alpha (tumor necrosis factor) by NK.      It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this     study confirm these results in vivo in peripheral blood cells in patients treated with     lenalidomide.   "
58088|NCT02525237|"     The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with     S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction     adenocarcinoma.   "
58100|NCT02525081|"     The aim of this study is to explore effects of long term treatment with ACE-inhibitor on the     small vessel function assessed by coronary flow reserve (CFR) by transthoracic     echocardiography and flow mediated dilation in normotensive patients with small vessel     disease (CFR<2.2) and Angina Pectoris but no obstructive coronary artery disease.   "
58089|NCT02525224|"     Healthy skin has been equated with a healthy diet leading to the inside out approach to     skin health. Since the skin is the barrier to the external world, healthy skin should lead to     overall better health. Conversely, the skin derives its nutrition from the internal body     requiring the consumption of nutritional supplements for optimal health. This research     attempts to examine skin attributes and improved appearance achieved after consumption of a     state-of-the-art dietary supplement.   "
58090|NCT02525211|"     The acute pain care, in particular after breast cancer surgery must be early and quickly     effective, because a severe postoperative pain increases the risk of chronic pain and exposes     to a risk of important embarrassment for the realization of simple daily movements.      Associated to conventional analgesics administered by systemic way, a local anesthesic     (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the     operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the     surgical unit by the surgeon at the end the surgical procedure.      Besides the control of the postoperative acute pain, the local anesthesic could intervene in     the prevention of the chronic pain, the early recovery, the reduction of the neuropathic     pains and the decrease of needs in morphine after mastectomy.      The duration of hospitalization being lower than 48 hours for this type of surgery, the     investigators envisage an immediate follow-up in the Units of Care then at home, what will     require a training of the hospital actors and at home (patient, family, visiting nurse,     general practitioner).      Although proposed for several years, the CCP after breast surgery is still a little spread     technique and few works had evaluated the pain at rest and at mobilization after mastectomy,     the early rehabilitation, and to spread its use towards home, that is why we propose a     randomized double-blind study ropivacaine / placebo in patients after mastectomy.   "
58091|NCT02525198|"     There is a dearth of research which takes a multi-compound approach to dietary interventions,     in humans, aimed at improving outcome measures of cognition. Animal research in particular     points towards fatty acids and flavonoids having a potentiating effect on each other, and     possibly even being synergistic. Thus, study products will be administered in the present     trial comprising both of these compounds, with a view to investigating their potential     effects on cognition in older adults with mild cognitive impairment (MCI) or subjective     memory impairment (SMI).   "
58092|NCT02525185|"     Cardiac resynchronisation therapy (CRT) has been documented to be a powerful treatment in     patients with severe congestive heart failure. However, 30-40% of patients receiving a CRT     are non-responders. In this study the investigators will use a previously validated method to     estimate myocardial segment work non-invasively by speckle-tracking echocardiography and     blood pressure. Since segments which shorten in systole perform positive work, whereas     segments which lengthen do negative work, the investigators will calculate wasted work as     negative work in percentage of positive work. The main purpose of the study is to determine     if wasted work can predict response to CRT.   "
58093|NCT02525172|"     The purpose of this study is to assess anti-recombinant human acid α-glucosidase (anti-rhGAA)     antibody titers after treatment with immune modulation therapy in patients of Pompe disease.   "
58094|NCT02525159|"     Breast cancer is a public health problem in Mexico and its incidence rises when the woman is     still premenopausal. Estrogen metabolism has been linked to breast cancer. Several studies     reported that high concentrations of 2 hydroxyestrone (2OHE1) in urine have a protective     effect for this neoplasia, whereas high concentrations of 16 alpha-hydroxyestrone (16αOHE1)     in urine have the opposite effect, further has been reported that women with a ratio of     estrogen metabolites 2OHE1:16αOHE1 in urine (REMU) less than 0.9, have ten times the risk of     developing Breast Cancer than those women with an RMEU equal or more than 0.9. Other studies     have showed that the active compounds of cruciferous vegetables, indole-3-carbinol (I3C) and     its dimer, 3'3'diindolylmethane (DIM) induce benign pathway of metabolism of estrogens     producing 2OHE1. Several studies, evaluate the pharmacokinetics and effect of I3C     supplementation, finding that 300 to 600 mg of this compound are well tolerated and able to     promote formation of 2OHE1 in women when supplemented for one month. In the case of DIM, only     a pilot study has explored its effect in postmenopausal women with personal history of breast     cancer in early stages, reporting an increase in the concentrations of 2OHE1. The purpose of     this study was to evaluate the effectiveness of supplementation with DIM to increase urinary     RMEU in premenopausal women at risk of Breast Cancer (RMEU less than 0.9). A clinical,     randomized, double-blind study was performed with women attending on the urogynecology     service of Institute National of Perinatology. Subjects were premenopausal women over 34     years who were healthy. The inclusion criteria's was had a RMEU less than 0.9 and were     excluded for any medical condition, medication, or dietary or lifestyle habit that might     interfere with estrogen metabolism. Patients were randomly assigned to one of two groups: one     received orally at a daily dose of 75 mg of DIM for a period of 30 days and other group     received orally at a daily placebo for a period of 30 days. All urine samples were collected     from the women before DIM or placebo ingestion, after 30 days of DIM or placebo ingestion and     finally after another 30 days once suspended supplementation. Analysis of the 2OHE1 and     16αOHE1 were determined using a commercially kit ESTRAMET™. The change in metabolites median     concentrations and RMEU was assessed through the Wilcoxon test and these differences between     groups through U Mann-Whitney test.   "
58095|NCT02525146|"     The purpose of this study is to determine whether a modified form of the ARTAS     (Antiretroviral Treatment and Access to Services) intervention, adapted for HIV patients who     have fallen out of care, can be successful in re-engaging patients in care and reducing HIV-1     viral load.   "
58096|NCT02525133|"     This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled     efficacy and safety study of postoperative pain in adults who are scheduled for unilateral     inguinal hernioplasty via open laparotomy (tension-free technique).      Patients will assess their postoperative pain intensity (PI) using an 11-point numerical     rating scale (NRS) from 0 hour through 72 hours postoperatively.      The expected maximum study duration for each patient will be up to 60 days, including a     maximum 30-day screening period, the day of surgery and implantation, and a 30-day post     implantation period including treatment and follow-up.   "
58097|NCT02525120|"     The primary objective of this study is to compare the early clinical outcomes following     non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less     than or equal to 6 months.   "
58098|NCT02525107|"     140 SCD patients [70 on Hydroxyurea] will receive Omega-3 capsules whereas another 140 SCD     patients [70 on Hydroxyurea] will receive placebo and will be recruited from the Sultan     Qaboos University Hospital [SQUH] haematology specialty clinics. Patients will be randomized     in a 1:1 ratio to receive placebo or Omega-3 for 52 weeks. The aim is to investigate the     therapeutic potential of omega-3 fatty acids in the prevention of vaso-occlusive crisis in     Omani patients with sickle cell disease[SCD].   "
58099|NCT02525094|"     To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis   "
58101|NCT02525068|"     A multicentre prospective, randomised, phase II interventional study in mCRPC patients     previously treated with 1‐2 lines of chemotherapy and at least 12 weeks of abiraterone with a     safety run‐in and single stage phase II expansion cohort.   "
58103|NCT02525042|"     The main objective is to identify in the candidate regions of differentially expressed genes     by comparing the transcriptome of dendritic cells derived from circulating monocytes between     cases and controls. Cases and family controls will be matched on the presence of HLA-B27 and     depending on haplotype association studies to correlate the differences of gene expression     and genetic variations with susceptibility to AS.   "
58104|NCT02525029|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when     given in combination with standard immunosuppressive therapy in pediatric and adult patients     with high-risk (Arm 1) or refractory/dependent (Arm 2) aGVHD.   "
58105|NCT02525016|"     Intravenous lidocaine is efficient for management of post operative pain in abdominal     surgery. As previously published in literature the investigators use it during bariatric     surgery.      Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a     widespread use.      Investigators propose in this work to bring an objective proof that administration of     lidocaine based on a modified body weight is safe.      Intravenous administration concerned the peri operative period. A total of six samples are     taken for each patient.      Investigators get approbation of local ethic committee for this work.   "
58106|NCT02525003|"     Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However,     in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in     winter. Between November and March, dietary or supplementary vitamin D intake is essential to     maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a few     natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of     vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2     (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one     strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly     used in fortified products in Europe, although the production of plant-derived vitamin D2     would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3 are     limited. An important consideration is whether food-based sources of vitamin D2 are effective     in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The investigators     investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast in bread in     terms of efficacy of raising total S-25(OH)D) as well its possible effects on S-25(OH)D2,     S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations compared with     D2 and D3 supplementation in a randomized placebo-controlled trial in young healthy females     during winter in Finland.   "
58107|NCT02524990|"     The purpose of this operations research study is to evaluate women's interest in and     compliance with using a semiquantitative multi-level dipstick pregnancy test at home for     medical abortion follow-up.   "
58108|NCT02524977|"     Study objective was to improve decision-making and thromboprophylaxis for patients with     Atrial Fibrillation (AF) by developing and implementing a computerized decision support tool     for individual patient-level decision-making about oral anticoagulant therapy. To accomplish     these goals, the investigators studied the incremental impact of adding a quality-improvement     (QI) intervention to an educational package (for practice staff and clinicians) using a     computerized aid, the Atrial Fibrillation Decision Support Tool (AFDST) for individual     patient-level decision-making about oral anticoagulant therapy in patients with non-valvular     AF. The decision support tool incorporates individual patients' risk factor profiles for     ischemic stroke and bleeding and provides a recommendation for treatment based upon the     projected quality-adjusted life expectancy gained or lost with the addition of either oral     anticoagulant therapy or aspirin compared with no thromboprophylaxis.   "
58109|NCT02524964|"     Approximately 60 patients with ST-segment elevation myocardial infarction successfully     treated with primary percutaneous coronary intervention will be enrolled and randomized to     receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same     volume/day of normal saline.      The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed with     cardiac magnetic resonance imaging (MRI) at baseline and 6 months.   "
58110|NCT02524951|"     This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a     single intravenous infusion twice a week for 3 weeks on a 4-week cycle.   "
58111|NCT02524938|"     Type 2 diabetes mellitus (T2DM) is associated with an increased risk of kidney failure, with     high levels of glycohaemoglobin (HbA1c) presenting a sharper decline in renal function and an     increase in the risk of mortality and end-stage renal disease (ESRD). Polyphenols may improve     renal insufficiency in patients with diabetes with chlorogenic acids (CGA) one of the     principle polyphenol groups in the diet - coffee/tea, stone fruits (especially plums/prunes)     and some vegetables (artichoke, chicory). CGA (3-4 cups of coffee) has been associated with     25% lower risk of T2DM and a favourable reduction of HbA1c, blood pressure, and oxidative     stress levels. This randomised controlled trial, therefore, aims to evaluate the effect of     high CGA food on glycation and oxidative stress in T2DM subjects with early renal     insufficiency (glomerular filtration rate of 35-60 mL/min) as well as progression of renal     insufficiency and the risk of cardiovascular diseases.      The study will have two phases - phase I, an interventional study of 3 months followed by     phase II, an observational study of 21 months.      In phase I, subjects will be randomized into 2 groups: CGA-enriched diet group, or control     (habitual) diet group. The treatment group will be provided with a chlorogenic acid-rich food     (coffee) with instructions to achieve an intake of 400 mg per day (equivalent to 3-4 coffee     cups per day) for 12 weeks. The control group will receive a conventional coffee low in     chlorogenic acid.      Participants will attend three sessions during phase I; baseline, 6 weeks, and 12 weeks. At     baseline, general information, medical history, dietary habits and medication use will be     recorded and a Food Frequency Questionnaire completed. Urine and blood samples will be     collected and blood pressure, waist circumference, height and weight recorded. Participants'     diet over the previous 3 days will be assessed by estimated food diary analysis.      In phase II, written dietary recommendations will be provided at three time points (months 6,     12 and 24) - treatment group to achieve a CGA-rich diet (total polyphenol intake of at least     1g per day, and at least 400mg per day of CGA) and standard dietary advice for the control     group. Anthropometric/dietary data will be collected as well as blood and urine samples to     assess markers of renal function, glycation and oxidative stress, and proteomic markers of     cardiovascular disease, coronary artery disease and diabetes.   "
58112|NCT02524925|"     A prospective randomized clinical study, with cross-sectional comparisons and correlations     was conducted from May 2012 to July 2015 with a sample of 231 patients who have undergone     hepatectomy or pancreatectomy, randomized into 2 groups. In group A was applied     postoperatively the protocol Fast-track, while in group B the conventional postoperative     care. Demographic and clinical data were collected. In 170 patients, Neuropeptide Y (NPY),     Adrenocorticotropic hormone (ACTH)/Cortisol plasma levels were measured by ELISA method: a)     at the day of patient's admission, b) the operation day, c) the 3rd postoperative day or     prior to discharge.   "
58866|NCT02515045|"     To compare the use of an injectable compound containing an antibiotic and an     anti-inflammatory at time of cataract surgery to standard of care that is the use 3 different     topical medications to prevent inflammation and infection after routine cataract surgery.   "
58113|NCT02524912|"     Methadone maintenance treatment (MMT) has been one of the most effective treatment choices     for opioid addicts to reduce their heroin use, criminality and spread of HIV. In Taiwan, MMT     has been introduced since 2006. To date, more than 30,000 opioid addicts have ever     participated in MMT, but only around 10,000 retains in treatment. Outcomes of the     ever-treated MMT patients remain unclear. It is crucial to trace the opioid addicts'     treatment career, outcomes and unmet treatment needs for the service providers to modify     treatment strategy to help these individual to maintain abstinence. Moreover, understanding     of the determinants for these subjects' long-term outcomes is important for policy makers to     implement realistic policies to motivate the service providers and patients.      From the results of previous research, the research team found that early dropout, defined as     stayed in-treatment less than one month, of MMT participants were 14.4%. The rate of     maintaining in treatment at 3rd , 6th, and 12th month were 65.7%、51.3% and 33.8%,     respectively. Average treatment days for 12-month is 186.9±141.2. This result showed that the     effectiveness of the MMT was varied among different facilities. On the other hand, the     quality of the MMT can be improved largely through different dimensions. Besides, if one     participant can enhance its motivation in staying in-treatment, it could reduce 15% early     dropout. Above all, the result also showed that though the quality of life was recorded as     improved after MMT, it appeared to be significantly lower than their healthy counterparties.     The assessments of health outcomes after participating MMT are rare, but in need. It is     necessary to make some modification to improve the effectiveness. Moreover, the evaluation of     the needs shall not limit to patients, but also extend to their family members.      Therefore, in this study, the research team plans to probe the dimensions from physical,     psychiatric, to social conditions by assessing patients and their family members after     treated by MMT for five years. The research team would like to know more about the outcomes     of those who attended MMT five years ago, their physical and mental health conditions, also     health status of their family members.   "
58114|NCT02524899|"     This is a study to assess the efficacy augmenting cognitive remediation therapy (CRT) with a     pharmacological agent for individuals with schizotypal personality disorder (SPD). Impaired     cognition, along with functional and social skill deficits, is a core feature of     schizophrenia and schizophrenia spectrum disorders. A better understanding of the cognitive     and functional impairments in schizophrenia-related conditions, as well as the identification     of interventions that can reduce these impairments, are vital to improving outcomes for     individual with these disorders.   "
58115|NCT02524886|"     Rationale: Tardive dyskinesia and dystonia (TDD) are severe side effects of dopamine blocking     agents, particularly antipsychotics. Deep brain stimulation (DBS) has shown to be effective     in the treatment of TDD in psychiatric patients, but only reported in case reports and small     clinical trials and with little attention to possible psychiatric or cognitive complications     or positive effect on psychiatric symptoms.      Objective: To assess whether treatment with DBS can reduce or resolve TDD and if DBS can     induce beneficial or side-effects in particular psychiatric symptoms.      Study design: A delayed onset double blind randomised controlled trial. Study population:     Adult patients with a current or previous psychiatric disorder and antipsychotic induced TDD     with a stable psychiatric status during the past 6 months.      Intervention: All patients will be treated with DBS in the posteroventrolateral GPi. The     groups will be randomised into immediate stimulation or delayed stimulation after 3 months.      Main study parameters/endpoints: Primary objective, improvement on the movement rating scales     BFMDRS. Secondary objectives improvement on the quality of life measured on the SF-36,     psychiatric stability as measured on the BPRS and the MADRS and cognitive effects as measured     on the MATTIS Dementia Rating Scale, Nederlandse Leestest voor Volwassenen (NLV), 15 word     test, Facial Expression of Emotion S+T (FEEST), Groninger Intelligentie Test woordopnoemen     (GIT), category and letter fluency test, Trail Making Test part A and B and the Stroop colour     and word test   "
58116|NCT02524873|"     Whether patients with a functional genotype of a protein important in blood pressure     regulation respond better to a drug therapy class/combination of therapy classes that target     that specific pathway using the Geneticure panel for high blood pressure   "
58117|NCT02524860|"     The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting     clinically significant prostate cancer in a standard clinical environment.   "
58118|NCT02524847|"     This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen)     Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems in pediatric     patients with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and     Follow-up Periods.   "
58119|NCT02524834|"     This is an early feasibility study that investigates the outcome of selected patients with     complex thoracoabdominal aortic lesions who are suitable for endovascular (within the vessel)     repair with a physician-modified Medtronic Thoracic Valiant stent graft. The Medtronic     Valiant System includes a Valiant Thoracic Stent Graft, a self-expanding, tubular end     prosthesis which is modified/customized by the Investigators to fit the patient's anatomy.     The device is constructed by making a taper in the larger proximal thoracic device and     attaching it to a smaller distal thoracic device. The Viabahn branches for the visceral     vessels are sutured to holes made in the tapered section. The modified Valiant stent graft is     advanced to the lesion site endoluminally via the iliac/femoral artery. Access for delivery     of extensions to the device will be delivered through the left subclavian artery. Upon     deployment, the stent graft self-expands at the target location, where it is designed to     exclude the lesion by restoring blood flow through the stent graft lumen.   "
58120|NCT02524821|"     The purpose of this study is to determine the effect of Gelesis100 on the absorption of     metformin both with and without a meal.   "
58121|NCT02524808|"     This is an observational prospective study. Patients diagnosed with advanced epithelial     ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by     signing an informed consent. Tumour samples will be reviewed to confirm the diagnosis and to     select the best regions for tissue sampling to perform the following molecular studies:     array-based Comparative Genomic Hybridization and Next Generation Sequencing. Detected     mutations will be analysed by Sanger sequencing. FISH probes will be designed and tested on     the samples.   "
58135|NCT02524626|"     Hypothesis:      Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead     to a faster postoperative recovery after abdominal surgery.      Aims:      In the present study, the investigators want evaluate the anti-inflammatory effect of     peroperative electrical stimulation of the vagus nerve. In addition, the investigators want     to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To     this end, the following aims are formulated:        1. to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal          transit using radiological testing        2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical          improvement (daily questionnaire)        3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the          inflammatory response to abdominal surgery   "
58122|NCT02524795|"     Omega-3 fatty acids have been considered anti-inflammatory lipids based on data from     epidemiological studies of Greenland Eskimos whose diet is rich in fish, sources of     polyunsaturated fatty acids.      Fatty acids from the omega-3 family [mainly the α-linolenic acid, eicosapentaenoic (EPA) and     docosahexaenoic (DHA)], as well as those of the omega-6 family [represented mainly by     linoleic acid and arachidonic acid (AA)] are essential for the synthesis of eicosanoids,     prostaglandins, leukotrienes, thromboxanes and other oxidative factors, major mediators and     regulators of inflammation.      Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease characterized by the     loss of balance of cellular immunoregulation and increased levels of circulating inflammatory     mediators.Thus, omega-3 supplementation could represent additional therapy for individuals     with SLE.      The aim of this study was to investigate the effects of omega-3 fatty acids on circulating     levels of inflammatory and biochemical markers in women with SLE.   "
58123|NCT02524782|"     A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to     evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of     MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).   "
58124|NCT02524769|"     The medical field is beginning to adopt treatments that alter an individual's microbiome to     improve patient health; however, this approach has not been adopted for treatment of lower     urinary tract symptoms (LUTS). Here, the investigators propose the first step in development     of such a therapy. If the investigators hypothesis is correct, the investigators could change     the first line of treatment for hypoestrogenic women and develop future therapies that     modulate bacteria in the bladder to improve not only LUTS but also treatment response. This     could lead to the first treatment for lower urinary disorders that incorporates a person's     individual microbiome.   "
58125|NCT02524756|"     The aim of this study is to assess:        1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type          III/C1 as regard surgical technique, blood loss and operative time.        2. Evaluate patients' outcome as regard bladder function and quality of life.      in order to preserve the function of the bladder and the rectum, it is necessary to modify     the traditional procedures, so as to identify the precise anatomical information directing     the technique for optimal preservation of bladder function at the time of radical     hysterectomy.      The laparoscopic technique offers several well-known advantages. Under the magnified view of     the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and     precise dissection of the para-cervical structures and areolar tissue, including the blood     vessels and the nerves.      Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior     hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good     knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as     this qualification could prohibit long-term bladder and voiding dysfunction during     nerve-sparing radical hysterectomy   "
58126|NCT02524743|"     The purpose of this study is to determine whether efficacy of different doses of lidocain and     acetaminophen for the prevention of rocuronium injection pain and frequency of withdrawal     movements during the general anesthesia induction period.   "
58127|NCT02524730|"     The purpose of this study is to collect basic function, radiographic and patient satisfaction     data for observation and analysis.   "
58128|NCT02524717|"     The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in     participants with mild and moderate hepatic impairment.   "
58129|NCT02524704|"     The goal of this feasibility study is to evaluate the ability of Electrical Impedance     Tomography (EIT) for providing regional and quantitative information about the extent and     nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted     to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography     low amplitude, low frequency current is applied on electrodes, and the resulting voltage is     measured and used to computed the electrical properties of the interior of the chest as they     change in time. The computed properties are used to form an image, which can then be used for     monitoring and diagnosis.   "
58130|NCT02524691|"     The study is designed to establish the level of agreement between the ROM Plus test and the     diagnosis of ROM as defined by the patient's clinical course, with respect to a population of     pregnant women who present to the clinical site with signs and symptoms suggestive of ROM.   "
58131|NCT02524678|"     The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in     healthy subjects.   "
58132|NCT02524665|"     One of the main success factors in acne therapy is user compliance with treatment, product     cost, availability and ease of use. Poor compliance may translate into decreased efficacy     (either not improving symptoms well enough or not improving symptoms fast enough),     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a     lack of understanding of the instructions for use, or product cost/availability. Whatever the     reason, poor compliance translates to decreased efficacy and increased frustration on the     part of the user.      The current study will evaluate and compare the efficacy and tolerability of 2 over the     counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5%     benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam     compared with MURAD Clarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne     Treatment Gel (1% SA) and Skin Perfecting Lotion.   "
58133|NCT02524652|"     Early rehabilitation after anterior cruciate ligament reconstruction is of paramount     importance and requires optimal pain control based on a multimodal concept, including     injection of local anaesthetics. Regarding this latter, different options have emerged     recently such as the adductor canal block, performed before the surgery by the     anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of     the intervention. No trial has compared these two approaches. As practice of medicine should     be based on evidence, we decided to undertake this randomised controlled trial where we     compared the adductor canal block with the local infiltration analgesia technique in terms of     pain and functional outcomes   "
58134|NCT02524639|"     The purpose of this pilot study is to generate data to assess feasibility of study     design/procedures and for formal sample size estimation for a larger multicenter study of the     efficacy and safety of sirolimus in infants with medically-unresponsive congenital     hyperinsulinism (HI) due to inactivating mutations of adenosine triphosphate-sensitive     potassium (KATP) channels.   "
58136|NCT02524613|"     Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic     diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed     annually in the U.S. Most of them are performed by practicing hematologists/oncologists in     their offices or hospitals. However, a significant number are performed by     hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of     complications associated with bone marrow biopsy are largely unknown. This study has two     goals:        1. The first goal is to objectively determine by CT and clinical assessment, the actual          risk to patients of the bone marrow biopsy and the rate of pelvic injury in an          unselected group of hematology patients requiring a bone marrow biopsy, as performed by          hematologist-in-training.        2. The second goal is to determine the quality of bone marrow biopsies obtained, using the          lateral angulation technique.   "
58137|NCT02524600|"     Cardiological examination is one of the major directions in nuclear medicine for detection of     myocardial ischemia in patients with suspected coronary artery disease. In Caen, they     constitute 20% of the activity of nuclear medicine. It is evaluating a new versatile     innovative technology (IQ-SPECT) for performing rapid nuclear cardiological examinations (4     minutes) and quality on a SCINTI-CT camera for correcting the mitigation. This technical     solution IQ-SPECT was made available to the nuclear medicine department in August 2011. To     date, apart from the work on heart ghosts and one publication in abstract form in 2009, no     other study have been published.      The goal of the study is to study the technical performance of the innovative technology     IQ-SPECT during a SCINTI-CT imaging in patients suspected of coronary disease .   "
58138|NCT02524587|"     The total hip replacement, with over 120,000 cases per year in France, provides short term,     excellent functional results and a significant improvement in quality of life, in almost all     cases. However, the observation has shown that the lifetime of the implants is limited due to     aseptic loosening. One of the factors associated with these failures is a peri-prosthetic     osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions     have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the     two components of the couple) or improving quality polyethylene. Improving the resistance of     polyethylene wear is the primary objective evaluated in this study.   "
58139|NCT02524574|"     In patients with heart failure, the drive to the effort has demonstrated its safety and its     interest. Patients with heart failure, endothelium-dependent peripheral vasodilatation is     impaired by decreased activity of endothelial NO synthase. The rehabilitation training     significantly improves peripheral endothelial function, and this improvement is correlated to     the increase in exercise capacity. The impact on coronary endothelial function remains poorly     documented, especially in non-ischemic dilated heart disease.      The main objective of this study is to investigate the effectiveness of cardiac     rehabilitation on the restoration of coronary endothelial function in cardiac failure patient     evaluated with Tomography Positron Emission 15O-H2O.   "
58140|NCT02524561|"     Combined estrogen and progestin therapy has been shown to increase mammographic density and     incidence of breast cancer in randomized trials. The investigators propose to examine the     effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast     density, rates of abnormal mammogram, and circulating estrogens in the ongoing,     already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical     trial with a primary goal of examining the effects of low-dose transdermal versus oral     estrogen combined with cyclic micronized progesterone on progression of subclinical     atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short     duration and small size. By determining the effects of low-dose hormone therapy on the     breast, the proposed ancillary study will add important information about the estimated     balance of risks and benefits associated with low-dose HT and will help guide future research     trials.   "
58141|NCT02524548|"     The purpose of this study is to determine whether weekly SMS reminders are effective in     improving medication adherence of adjuvant aromatase inhibitors in women with breast cancer.   "
58142|NCT02524535|"     Regardless of age, the quality of hospital care, the confidence that the young can have in     the health care team, joining parents are pivotal elements and influence followed. Family     support is all the more important as 14% of young people realize a new suicidal act within     three months of hospitalization for attempted suicide, and that the essential predictors     appear to be the young age and quality of intra-family relationships.      The main objective of this study is to determine, through the construction of an instrument     to quantify the therapeutic alliance, defined by the characteristics of the mobilization of     the entourage and the mutual commitments in the care of nursing teams and the entourage, the     role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether     primosuicidants or repeat offenders, on short and medium term recurrences and early     mortality.   "
58143|NCT02524522|"     This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation     from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the     mechanical ventilation and the number of pulmonary complications in the early postoperative     period after cardiac surgery.   "
58144|NCT02524509|"     The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured     Chondrocyte) by comparing between Chondron implantation and Microfracture.   "
58145|NCT02524496|"     Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the     compassionate use of cisapride to treat patients who had no other effective therapy. For this     observational study, 3 patients who had already been prescribed cisapride by outside     physicians, were followed to determine the effectiveness of cisapride on their gastric     emtpying.   "
58146|NCT02524483|"     Background: Outcomes from the investigators' recent exploratory investigation suggested that     a high dosage of challenging physical therapy exercises can result in clinically relevant     improvements in the postural balance and walking speed of individuals with MS.      Objective: The investigators anticipated that the promising results were due to the novel     challenging postural balance and mobility exercises. The purpose of this investigation was to     test this notion by evaluating the mobility and postural balance improvements that could be     achieved in a cohort of individuals with MS who participated in a therapeutic protocol that     consisted of activity based exercises, and a cohort of individuals with MS that participated     in the challenging physical therapy protocol.   "
58148|NCT02524457|"     The purpose of the study is to describe the molecular mechanisms related to an increased     visceral fat mass and changed T-cell homeostasis. the project is expected to add new     knowledge to the field of metabolic diseases after menopause and increase the focus of how     lipid affects the development of metabolic disease in relation to the menopausal transition.   "
58149|NCT02524444|"     Randomized controlled single blind prospective comparative study.   "
58150|NCT02524431|"     The purpose of this study is to try to identify the cause of damage to the drainage system of     the eye (the trabecular meshwork). Damage to this system may cause elevation in the pressure     within the eye and thereby damage to the optic nerve and the vision.   "
58151|NCT02524418|"     This is a prospective evaluation of the clinical utility of the new cholangioscopy platform     SpyGlass DS. The aims of this study are to prospectively document the clinical utility and     technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and     management of pancreatic-biliary disorders.   "
58152|NCT02524405|"     The main objectives for this study are:        1. To investigate three novel, non-invasive ocular measurements in a cross-sectional study          of participants with various neurodegenerative dementias against standard cognitive          assessments and brain imaging measures; and        2. To assess the potential utility of ocular assessments for early detection in the          pre-dementia, i.e. the so-called Mild Cognitive Impairment (MCI) stage.   "
58153|NCT02524392|"     A randomized controlled trial comparing independent medical evaluation (IME) to treatment as     usual (TAU). Participants will be individuals reaching six months uninterrupted sickness     absence. Treatment as usual (TAU) is normal follow-up by a general practitioner (GP).   "
58154|NCT02524379|"     The purpose of this study is to determine the safety of using oral Glyburide (DiaBeta) in     patients with acute traumatic cervical spinal cord injuries (SCI).   "
58155|NCT02524366|"     We propose a randomized non-blinded comparison of standard vs. transcorporal approach for     placement of an artificial urinary sphincter in male patients with stress urinary     incontinence after radiation and radical prostatectomy for prostate cancer. In the United     States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is     the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff,     which is the portion of the device that encircles and occludes the urethra, is typically     placed directly around the urethra (i.e., standard placement). The cuff can erode into the     urethra. Transcorporal placement has been introduced as a method to reduce the risk of     erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so     as to protect the dorsal aspect of the urethra. This approach has never been compared to     standard placement in a randomized fashion. In our randomized trial, no additional procedures     beyond the normal care protocol will be required of the patients. We will conduct the study     through our established, IRB-approved multi-institutional network of surgeons. Success will     be assessed via objective and subjective methods; complications will be tallied in a     standardized fashion. Outcomes will be measured at two years.   "
58156|NCT02524353|"     Countless studies are performed to quantify the severity of heart disease and its influence     on the respiratory system, checking that their heart conditions and the surgical process     determine pulmonary complications, one of the most common causes of morbidity and mortality     in the postoperative period of cardiac surgery . After surgical procedures, there is a     reduction of the residual volume (RV), total lung capacity (TLC), vital capacity (VC) and     functional residual capacity (FRC), leading to the formation of atelectasis, with alterations     in the ventilation-perfusion ( V / Q), the partial pressure of carbon dioxide in arterial     blood (PaCO2) and partial pressure of oxygen in arterial blood (PaO 2).      Pulmonary function is impaired in the postoperative period of cardiac surgery, due to various     factors common to this major surgery that will drive the patient to develop respiratory     complications such as atelectasis and pneumonia. Physical therapy plays an important role in     the treatment of patients undergoing cardiac surgery, both in the preoperative period and     postoperative, in order to prevent or minimize the respiratory complications.      Follow-up studies on cardiac rehabilitation quantify the quality of all the activities     necessary to ensure to patients with heart disease patients the best physical , mental and     social conditions so that consequently they are able , with its effort to regain a normal     position in the community and lead a active and productive life over time, therefore, the     clinical changes resulting from an extensive cardiac surgery are already highly dedicated     described in literature but which daily life factors or rehabilitation interventions that the     patient will take in the late postoperative period that really assisted in his complete     recovery and inclusion into society they are still not well elucidated , so it is appropriate     to carry out this project due to the fact exposed to up.      The project to be developed whose main justification clarify issues related to the return or     preservation of the individual feature that undergoes extensive cardiac procedure , as well     as incidence of mortality after 12 months of the procedure. The current literature does not     expressed clearly, possible impacts on functionality and return the daily activities of the     individual in the late postoperative period , since such malfunctions in the immediate post     operative period are already fully understood.   "
58157|NCT02524340|"     The best treatment plan for Juvenile Idiopathic Arthritis (JIA) is often complicated.     Patients and clinicians often don't know what is the best treatment strategy for a given     patient at a given time. The purpose of this study is to develop a method to analyze data in     situations where the treatment and disease state change over time. The researchers will     develop a web-based package that will use the methods developed in this study. The package     will be easy to use and allow dissemination of the methods to the public.   "
58158|NCT02524327|"     The first aim of this study is to compare two methods of administration of intravenous     anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or     automated and to determine a mid-term (6 months) influence of the frail phenotype on     self-sufficient elderly patients after general anesthesia.   "
58159|NCT02524314|"     The purpose of this study is to collect safety and performance data on the use of the     Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and     alignment for the treatment of acute humerus fractures.   "
58160|NCT02524301|"     The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear.     Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia     nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a     ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the     interaction between endogenous opioids and their receptors.   "
58161|NCT02524288|"     The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) +     17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the number     of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess     the safety and tolerability of the ENG-E2 vaginal ring.   "
58238|NCT02523287|"     The purpose of this protocol is to generate a set of data that will be analysed by integrated     systems biology approach, for validation in subsequent clinical trials or in animal models.      240 healthy participants (18-45y) will be enrolled, 228 will be administered a dose of Fluad     on Day 0, 12 will receive a placebo on Day 0.   "
58162|NCT02524275|"     This phase II trial studies the side effects and how well docetaxel and capecitabine work in     treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that     has come back or spread to others places in the body. Drugs used in chemotherapy, such as     docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.   "
58163|NCT02524262|"     Atrophic gastritis with hypochlorhydric milieu is a risk factor for gastric cancer. Microbes     colonizing the acid-free stomach oxidize ethanol into acetaldehyde, a group 1 carcinogen. The     aim is to assess gastric production of acetaldehyde and its inert condensation product,     non-toxic 4-methyltiazolidine-2-carboxylic acid (MTCA), after alcohol intake under treatment     with slow-release L-cysteine or placebo.      Patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17     are studied. On separate days, patients will be randomly assigned to receive 200 mg     slow-release L-cysteine or placebo, then have intragastric instillation of 15% (0.3 g/kg)     ethanol. After intake, gastric concentrations of acetaldehyde, ethanol, L-cysteine and MTCA     are analysed for 4 hours.      Expected results show mitigated exposure of the gastric mucosa to acetaldehyde.   "
58164|NCT02524249|"     Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth     weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such     as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in     very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective     studies and recently published retrospective studies demonstrated that early caffeine given     within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns.     Retrospective design can be biased as newborns with mild lung disease may have received     caffeine early for extubation. There are several studies on pharmacodynamics and     pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine     levels and BPD outcome is deficient.      Primary objective of this study is to test the hypothesis that early caffeine given within 24     hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns.      This study will also test an additional hypothesis that higher caffeine dosage and caffeine     levels are associated with decreased mortality and postnatal morbidities in studied newborns.   "
58165|NCT02524236|"     The primary objective of this study is to compare the efficacy and safety of a single     injection of 50 U and 100 U doses of BoNT-A for the treatment of BPH-associated LUTS.   "
58166|NCT02524223|"     Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted     diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk     of oncogenicity especially for the anal and cervical mucosa. At the present time, no     recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP)     procedures. The main objective of this prospective multicentric cohort study is to evaluate     the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives     are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP,     (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the     correlation between HPV and male infertility and (4) the correlation between HPV and success     rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV     vaccination policy.   "
58167|NCT02524210|"     Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic     prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as     anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases     the risk of gastrointestinal bleeding compared to standard treatment (AVK) [3]. In these     circumstances the risk / benefit of dabigatran could be improved by combining it with gastric     protectors such as inhibitor drugs proton pump (IPP).      Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of     co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy     subjects.   "
58168|NCT02524197|"     To assess the safety and tolerability of orally-administered CR845 in patients with     osteoarthritis (OA) of the hip or knee. The study drug is being tested to reduce OA pain, and     will be taken twice a day for two weeks, with four different doses (strengths) being tested.     From screening period to follow up examination, the study is expected to last for up to 38     days per participant.   "
58169|NCT02524184|"     Obesity and metabolic disease result when energy intake consistently exceeds energy     expenditure. One appealing new target for treatment is the activation of brown adipose tissue     (BAT), an organ recently found to be functional in adult humans. Brown adipocytes selectively     express uncoupling protein 1 (UCP1), which renders the inner membrane of mitochondria leaky,     thereby diverting chemical energy from ATP generation to heat production. Interest in BAT has     been spurred by the recognition that in addition to classical BAT depots, other     brown-fat-like cells are present in the subcutaneous white adipose tissue (WAT) in animals     and also in humans.These cells have structural and functional properties that resemble brown     adipocytes, and they are referred to as beige or 'brite' (brown-in-white) adipocytes.     Interestingly, browning of WAT can be induced in animals and humans by physiological stimuli     such as cold exposure, which increases adrenergic tone, and by exercise, which selectively     drives WAT browning through irisin, an exercise-induced myokine. In addition b-adrenergic     drugs and other pharmacological agents,such as prostaglandins, can induce browning of white     adipose tissue. More recently, one study showed that treatment of C57BL/6 mice with     phosphodiesterase inhibitor sildenafil (12 mg/kg/d) for 7 d caused 4.6-fold increase in     uncoupling protein-1 expression and promoted establishment of a brown fat cell-like phenotype     (browning) of WAT in vivo. Therefore, the investigators hypothesized that sildenafil can     promote browning of white adipose tissue and improves insulin sensitivity in human adults.   "
58170|NCT02524171|"     The purpose of this study is to determine whether Moral Reconation Therapy (MRT) is effective     for reducing risk of criminal recidivism and improving other health-related outcomes     (substance use, mental health, housing, and employment problems) among justice-involved     Veterans entering residential mental health treatment programs in the Department of Veterans     Affairs (VA).   "
58239|NCT02523274|"     The purpose of this research study is to evaluate the effects of combining physical exercise     with a resveratrol supplementation on the physical function of older adults.   "
58171|NCT02524158|"     Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current     treatment options have limited effectiveness. In addition to chronic pain, people with     chronic low back pain experience increased disability, psychological symptoms such as     depression, and reduced health-related quality of life. This randomized controlled study will     examine the impact of yoga therapy for improving function and decreasing pain in VA patients     with chronic low back pain. Although not every VA patient with chronic low back pain will     choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to     many VA patients. If yoga is effective, it could become an additional low-cost option that     the VA can offer to better serve Veterans with chronic low back pain.   "
58172|NCT02524145|"     The purpose of this study is to determine the mechanisms of chronotropic incompetence     (inability to increase heart rate with exercise) in patients with heart failure and preserved     ejection fraction (HFpEF). The investigators will test both central command regulation and     cardiac beta-receptor sensitivity over control of heart rate.   "
58173|NCT02524132|"     In this research project, the investigators addressed if incorporating physical movements     with preschoolers will help increase their ability to retain concepts learned in preschool     such as letter, sound and number recognition. Movement plays an important role in the brain.     Exercise shows many benefits for the brain to help maintain clearer thought, improve memory,     and increase activity in the brain, especially the areas involved in memory, attention, and     language. The following research includes an eight week study of the implementation of     movement breaks with one preschool class, while using another class as a control group.     During the two weeks of baseline data, data was collected from every student in both groups     on their letter recognition with both upper and lower case, letter sound identification, and     number recognition for numbers 0-10. The group that implemented movement breaks had     three-five minute scheduled times to stop for movement. Data was collected and compared     between the two groups to find differences in their academic performance.   "
58174|NCT02524119|"     The purpose of this study is determine whether the combination therapy with LEE011 and     chemoembolization in patients with locally advanced Hepatocellular Carcinoma not amenable to     curative therapies will provide greater efficacy than chemoembolization alone with a     tolerable safety profile.   "
58175|NCT02524106|"     B-HIVE is a Phase 3, double blind, placebo-controlled, randomized, parallel group study,     designed to compare the efficacy and safety of bococizumab 150 mg subcutaneously every 2     weeks to bococizumab placebo subcutaneously every 2 weeks for LDL-C lowering in HIV-infected     subjects.   "
58176|NCT02524093|"     Depression and anxiety are common in MS and often go untreated. Even symptoms which do not     meet the threshold for a psychiatric diagnosis can have a significant impact on quality of     life. Positive Mental Training (PosMT) is a 12 week programme which aims to help people     overcome the negative thinking and feelings that come with worry and low mood and become more     positive, confident and resilient. To find out if Positive Mental Training is helpful in MS     the investigators are running a randomised controlled trial. The initial study is a pilot     tiral, the primary function being examination of the feasibility and acceptability of this     treatment in MS. Though sample size is small and consequently it may not be powered to detect     a significant change in symptoms in association with the treatment, this will also be     examined.   "
58177|NCT02524080|"     If patients get to optimal level of healthcare directly it will prevent suffering for both     patients and their relatives and moreover save a lot of resources. In the project Care at     the right care level (CRC) the Emergency Medical Services (EMS) will triage patients who are     in need of primary health care to the Primary Care (PC) instead of to the Emergency     Department (ED). This intervention should be implemented with the same medical safety as with     traditional care in the ED and the patient and their relatives should experience     corresponding confidence to the healthcare provider. To prepare this intervention this     patient group and their care needs have to be identified by a retrospective journal review     and a guideline has to be developed. To evaluate the patients' and their relatives'     experience of the intervention, finally interviews will be implemented. This project is     expected to provide answers whether it is possible to triage non-urgent patients to another     care level with the same medical safety and that the patients experience the same confidence     in healthcare. And further it will answer the question, if the care providers around the     patient manage to collaborate.   "
58178|NCT02524067|"     This study examines the effect of an intervention consisting of dynamic circadian light and     sound therapy, as well as systematic information on sleep pattern, agitated behavior and     functioning level.   "
58179|NCT02524054|"     The purpose of this protocol is to develop and test aerosol furosemide, as a treatment that     has the potential to significantly improve symptom management and enhance the quality of care     for patients with intractable dyspnea.   "
58180|NCT02524041|"     Based on the evidence that periostin is specifically involved in intra-cortical remodeling     control, our working hypothesis is that assessment of its concentration in the serum would be     helpful in identifying patients with severe cortical porosity, a critical parameter in bone     fragility. Periostin expression by osteoblasts and osteocytes is part of the bone cortical     response to anabolic stimuli such as mechanical strain or intermittent increase in     parathyroid hormone. However, it remains unknown whether this expression may participate as     well to mechanisms that will lead to exaggerated intra-cortical remodeling and subsequent     bone loss.      In rare clinical situations in which trans-iliac bone biopsies will be necessary to better     understand their bone status in addition to densitometry and biological bone markers     assessment, specific analyses using immune-staining techniques will be performed on the bone     sample. Data from routine follow-up every six months will be also collected in this specific     sub-group.      High resolution peripheral quantitative computerized tomography (HR-pQCT) gives the     opportunity of performing a virtual bone biopsy providing information on trabecular and     cortical microarchitecture in vivo. These microarchitectural parameters allow a more accurate     evaluation of the alteration of the bone structure and therefore of the fracture risk as     compared to current tools used in clinical practice such as densitometry. However, the     availability of such HRpQCT facilities is limited and there is on-going development on the     best way of measuring porosity for example. The definition of a biological profile including     key proteins such as periostin and sclerostin involved in porosity mechanisms is therefore of     great interest. A better understanding of the relationship between bone matrix components and     parathyroid hormone effects also appears as critical. Follow-up of routine evaluation     parameters reflecting bone status in a subgroup of specific patients could also provide new     and additional information.   "
58269|NCT02522884|"     This is a prospective, multi-center, single-arm, non-blinded study designed to investigate     the safety and efficacy of the Tack Endovascular System in subjects with post-balloon     angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and     proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.   "
58181|NCT02524028|"     The fMRI study is a prospective study with the objective of evaluating the effects of the     autonomic central nervous system on the regulation of heart rate in patients with atrial     fibrillation (AF). This study will compare a functional MRI (fMRI) scan in patients prior to     a direct current cardioversion (DCCV) to a second fMRI scan taken post DCCV. In addition,     this study will compare functional MRI (fMRIs) to a control group of heart healthy,     age-matched patients who will also receive two fMRI scans spaced about one week apart.      Our expectation is that at the end of this study, the investigators will have greater insight     into the role of the central nervous system and more specifically the autonomic nervous     system in modulating AF. The investigators expect that understanding the interaction between     the central nervous system and cardiac arrhythmias will lead to the development of novel     therapies that preserve and restore normal sinus rhythm. This study will serve as a pilot     study with the goal of obtaining additional grant funding and expanding the study once     differences in volumes of activation are demonstrated.   "
58182|NCT02524015|"     The purpose of this study is to see if a specific physical therapy intervention speeds     recovery from stroke-related pusher syndrome.   "
58183|NCT02524002|"     The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel     during labor speeds labor and reduces the rate of cesarean delivery.   "
58184|NCT02523989|"     The purpose of this study is to explore the relationship between arsenic methylation and     blood metals in children with developmental delays and its correlation with health related     quality of life.   "
58185|NCT02523976|"     In this single-center, open-label, no control,prospective clinical trial, a total of 30     Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) patients will be     enrolled. Dasatinib 100 mg per day will be given orally along with combination chemotherapy     starting day 8 of induction chemotherapy. Dasatinib will be given continuously (if it's     tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation     chemotherapy and maintenance therapy.Patients can receive allogeneic hematopoietic stem cell     transplantation (HSCT) or autologous HSCT whenever possible during their first CR. Otherwise,     they will finish the consolidation chemotherapy. The purpose of current study is to determine     the clinical efficacy and tolerability of combination therapy of Dasatinib with multi-agent     chemotherapy in newly-diagnosed Ph+ ALL.   "
58186|NCT02523963|"     The purpose of this study is to identify the effects of family work shop for children with     developmental delays.   "
58187|NCT02523950|"     The purpose of this study is to evaluate the safety and efficacy of staged and combined     phacoemulsification with intraocular lens implantation and Descemet membrane endothelial     keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical     and postoperative complications, visual acuity and corneal endothelial cell density are     evaluated.   "
58188|NCT02523937|"     The purpose of the study is to evaluate the performances of Soluble Fibrin assay for     exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to     determine the threshold value from the ROC curves, the possible interest in the positive     diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on     the SF results.   "
58189|NCT02523924|"     This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel     low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical     prostatectomy.   "
58190|NCT02523911|"     The purpose of this study is to investigate Suprep bowel preparation, with and without the     anti-gas medication simethicone, in terms of efficacy and patient tolerability in the     preparation of patients undergoing routine colonoscopy for colorectal cancer screening.   "
58191|NCT02523898|"     Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility which     affects 12-21% of the population.Several studies performed evaluate the possible benefit of     metformin alone or in combination with clomiphene (CC)as first-line treatment for infertility     in women with PCOS have reported conflicting results. These conflicting results may be due to     the presence or absence of insulin resistance(IR).Metformin decreases IR .However there is     not a single randomized clinical trial with metformin in IR PCOS patients. Therefore, the aim     of current study is to compare CC with coadministration of metformin and with CC with     coadministration of placebo in IR PCOS patients to induce ovulation.   "
58192|NCT02523885|"     To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient     management at the early stage of community-acquired pneumonia (CAP) requiring hospital     consultation. Non-interventional observational study.   "
58193|NCT02523872|"     The specific aim of this study is to gather data on fluid balance, intravenous medication     administration, electrolyte balance, and diuretic and dialysis use in patients with acute     respiratory failure who might benefit from a strategy designed to limit fluid administration.   "
58194|NCT02523859|"     This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia.     Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil     as opioid analgesics and a neuromuscular blocker.      In total, 530 patients will be randomized. This group of 530 patients will be split randomly     into 2 groups as follows:      • 106 patients will be randomized to induction with propofol plus fentanyl or sufentanil or     remifentanil and a neuromuscular blocker. Throughout maintenance, the patients will receive     propofol and remifentanil until weaning from the mechanical ventilation on the ICU or PACU     within 24 hours after induction.      Afterwards, sedation with propofol as study medication has to be ended. If necessary, the     sedation is to be continued with the hospital's own supplies (propofol or other sedative).      • 424 patients will be randomized to induction with remimazolam 6.0 mg/kg/hr together with     fentanyl or sufentanil or remifentanil and a neuromuscular blocker. Throughout maintenance,     the patients will receive remimazolam and remifentanil until weaning from the mechanical     ventilation on the ICU or PACU within 24 hours after induction.      The primary endpoint is successful sedation is defined as a Narcotrend index of 60 or less     during at least 85% of the maintenance time and no rescue sedative medication administered.     The maintenance starts at arrival at the operation theater and ends with the completion of     the last skin suture.   "
58270|NCT02522871|"     A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness     of the OCS™ Liver to preserve and assess donor livers intended for transplantation.   "
58196|NCT02523833|"     Hypersensitivity pneumonitis (HP) is a syndrome with variable clinical presentation in which     lung inflammation is caused by inhalation of specific organic antigens or low molecular     weight particles in previously sensitized individuals. Systemic symptoms may or may not be     present. Chronic HP represents the final stage of the disease, caused by prolonged exposure     to a particular antigen, leading to pulmonary fibrosis. In chronic HP, pulmonary function     tests (PFTs) commonly present a restrictive ventilatory pattern, with decreased diffusion of     carbon monoxide (DLCO). Some patients can also have obstructive disorders with expiratory     flow limitation, due to obstruction of the small airways typically caused by bronchiolar     involvement in this pathology. However, PFTs are relatively insensitive for detecting small     airway involvement when there is concomitant interstitial fibrosis. First, conventional PFTs     may be normal in patients with small airway involvement, since they contribute to less than     30% of the total airway resistance. In addition, damage to the small airways in HP is     generally occurring parallel to areas of focal fibrosis - even when small airways are     involved, these regions can be completely ignored, since they are excluded from ventilation.     In summary, traditional PFTs are not sufficiently sensitive to detect diffuse small airway     involvement in these diseases. In these cases, other functional tests, such as forced     oscillation technique (FOT) and high resolution computer tomography (HRCT) scans of the chest     with expired studies, could be used for this purpose.      This will be a cross-sectional study, which will include the following evaluations in 28     patients with HP recruited from our clinic:      - Clinical variables: (A) demographic and anthropometric data; (B) Clinical data: Onset of     symptoms and time of diagnosis      C) Dyspnea score:      D) Smoking: * Current or former smoker * Smoking history (number of cigarettes smoked per day     and for how long);        -  Spirometry with forced and slow maneuvers before and after bronchodilator (salbutamol);        -  Plethysmography to measure lung volumes;        -  Diffusion capacity of carbon monoxide (DLCO);        -  High-resolution chest CT with expiratory scans;        -  Six-minute walk test;        -  Cardio-respiratory test using a maximal incremental treadmill.        -  Forced oscillation technique (FOT).   "
58197|NCT02523820|"     The purpose of this study is to evaluate the efficacy and adverse effect of nebulized     corticosteroid to prevent post-extubation stridor in children.   "
58198|NCT02523807|"     Patients with tremor may have varying degrees of tremor at different times. The amplitude and     frequency of tremor may change. The investigators observational study is intended to document     this tremor.   "
58199|NCT02523794|"     The purpose of this study is to evaluate the efficacy of electro-kinetically modified water     (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis     associated pain, and to evaluate the effect of EMW consumption on analgesic use for     endometriosis associated pain.   "
58200|NCT02523781|"     It is known that preeclampsia is a risk factor for cardiovascular diseases, diabetes, chronic     hypertension, nephropathy and thromboembolism. The study's aim, subsequent to these     informations, is to help prevent those consequences. Information tools have been known to     enhance retention of information given orally. The objective of this study is to assess the     knowledge and satisfaction of women after an episode of preeclampsia after reading an     explanatory pamphlet on preeclampsia. The investigators also want to change their perception     on cardiovascular risk, their risk of recurrence and preeclampsia's medium to long-term     consequences and the ways to prevent them.   "
58201|NCT02523768|"     IgA nephropathy (IgAN) is a histologically defined glomerulonephritis (renal biopsy) by the     presence of deposits immunoglobulin A (IgA) in the renal mesangium (at least 1+) by     immunofluorescence. The clinic allows excluding secondary forms (10-15%). Recurrence of this     condition on the renal graft is time-dependent and confirmed in 25 to 50% of 10 years     post-transplant.      The primary immunosuppressive induction regimens currently used in kidney transplantation are     the anti-lymphocyte globulin (GAL) whose main target is human T lymphocytes (ATG, polyclonal)     and monoclonal anti-CD25 antibodies (α chain of the interleukin receptor 2 in the surface of     T lymphocytes). Due to their potent and prolonged immunosuppressive properties, the ATG may     prevent or delay the recurrence on renal transplant.      The aim of this study was to evaluate the influence of induction therapy (ATG versus     Basiliximab) in the cumulative incidence at 5 years of (IgAN) recurrence after a first kidney     transplant.      This is a prospective, multicenter, randomized, open trial with a follow-up period of 5 years     old.      Patients in the ATG arm will receive 5 antilymphocyte globulin infusions Fresenius® (rabbit     immunoglobulin antilymphocyte human T-Fresenius® said ATG) from Day 0 to Day + 4     post-transplant (day 0 one dose of 4mg / kg, day 1 one dose of 4mg/kg, day2 one dose of     4mgkg, day 3 one dose of 3 m/kg and day 4 and one final dose of 3 mg/kg) and the patients in     the anti-CD25 arm will receive 2 doses of 20 mg of basiliximab (Simulect®) pn day 0 and day 4     after the graft. The maintenance immunosuppressive therapy is left to the discretion of the     center.      The primary endpoint will be the clinical and histological recurrence of IgAN defined by the     presence of mesangial deposits of IgA (at least 1) by immunofluorescence on a biopsy of the     graft triggered by the onset of proteinuria 1g/j and/or microalbuminuria greater than 300 mg     / day.   "
58202|NCT02523755|"     With an efficient epidural analgesia the physiological effects of pain are disabled during     labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of     paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after     labor with and without epidural analgesia. With more efficient breathing, the occurence of     atelectasis should be reduced; this effect will be investigated in these settings for the     first time with the electrical impedance tomography, which is a completely non-invasive     measure.   "
58203|NCT02523742|"     Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced     by a language task were significantly lower in a semantic region of the left hemisphere     (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri     medium and angular) in schizophrenic patients compared with controls matched for age, sex,     level of education and handedness.      Investigators wish to test the hypothesis that functional modification of the hemispherical     specialization is specific language and also specific for schizophrenia.   "
58204|NCT02523729|"     Human milk is the most optimal food to provide all infants' needs before eating solid food.     However, underproduction of milk is a common and concerned problem for breastfeeding women.     In this case, proper milk-making foods reveal their importance on lactation. In many European     countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate the     secretion of breast milk. This study estimates the effects of non-alcoholic malt product     during first three months of lactation.   "
58205|NCT02523716|"     To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically     active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary     functional capacity.   "
58206|NCT02523703|"     Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning     most often in subjects aged 20-40 years. In France, thanks to recent studies reported during     general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3     / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower Normandy,     the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per year.      The primary objective of this pilot study is to assess the levels of glutamate and aspartate     (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in     40 patients experiencing an event demyelinating central nervous system.   "
58207|NCT02523690|"     ICU acquired muscle weakness is a significant problem in patients recovering from critical     illness. This trial will evaluate the safety and efficacy of a drug in improving muscle     weakness in critically ill patients.   "
58208|NCT02523677|"     The purpose of this study is to examine relationships among lifestyle behaviors (i.e.,     physical activity, sleep), cognitive function (i.e., memory, processing speed, and executive     function), and quality of life in breast cancer patients and survivors across time. The     investigators will compare the strength of these relationships across age cohorts and time     since treatment and diagnosis. Participants will complete a battery of questionnaires and a     set of cognitive tests on an iPad app specifically tailored for this study. A subset of     participants will also wear an accelerometer for seven days. Data will be collected at     baseline and 6-month follow-up.      This research is critical to identifying potentially important approaches to improving health     outcomes and quality of life in breast cancer patients and survivors. Previous research     provides evidence of the influence of lifestyle behaviors on cognition and quality of life in     healthy aging populations. However, despite data indicating cancer's negative impact on     lifestyle behaviors, cognition, and quality of life, very few studies have investigated     interactions among these factors in cancer patients and survivors.   "
58209|NCT02523664|"     To investigate which neuronal correlates underlie cortisol-induced enhancement of memory     retrieval in PTSD and BPD.   "
58210|NCT02523651|"     The purpose of this study is to evaluate the safety of clinical injection of allogeneic human     dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether     injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal     disease.   "
58211|NCT02523638|"     Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic     increase of red blood cells and frequently also of white blood cells. The thickening of the     blood in relation with a modified function of the cells has several consequences like     increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the     brain as well as fingers and toes and an increased risk of arterial and venous thrombosis     (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction,     deep vein thrombosis in the legs. In case of a strong increase of platelets there is an     additional risk of bleedings. As the disease progresses the size of spleen and liver     increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a     progression at a later time point to a leukemia (increased formation of white blood cells)     can occur.      The aim of this study is to assess the ease of AOP2014 self-administration using dedicated     questionnaires.        -  To assess safety and tolerability: adverse events (AEs), laboratory parameters,          electrocardiogram (ECG) throughout study.        -  To assess maintenance of the blood efficacy parameters Hct (Hematocrit), WBC (white          blood cells) and PLTs (platelets) and spleen size (comparing values at Visit P7 vs.          values at Visit P1).        -  To assess the feasibility of AOP2014 self-administration: defined as the ability of the          patients to use the pen as a self-administration tool (ease of handling, safety,          tolerability and efficacy).   "
58212|NCT02523625|"     Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in     the elderly and which can lead to blindness in 20-30% of untreated cases. The study group     have previously shown that ultrasound is a viable non-invasive alternative to temporal artery     biopsy in diagnosing GCA. However, there is significant variation in ultrasound assessment     (measuring a dark halo around the abnormal blood vessels) between sonographers in different     centres, requiring a labour intensive and time consuming training programme. The study group     propose to standardise the training programme, and use ultrasound and clinical evaluation to     define changes occurring over time and with treatment in patients with a diagnosis of GCA     made based on ultrasound changes alone. The study group will explore the use of algorithms to     automate or semi-automate image interpretation.   "
58213|NCT02523612|"     Routine screening mammography has increased the non-palpable suspicious lesion detection     rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast     biopsy is associated with two interrelated risks:        1. The risk of underestimating the severity of the lesion biopsied currently leads          systematically to achieve a surgical resection for these patients while a breast cancer          (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary          surgeries will be performed in 75 to 90% of cases (no cancer).        2. These breast lesions confer long-term increase in the subsequent risk of breast cancer          (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical          lesions are then followed using clinical and mammographic annual evaluation.      The goal would be to get a model to assess the risk and no longer operate those patients at     high risk of BC. Several groups have attempted to identify predictors of concurrent or     secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are     often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia,     atypical lobular hyperplasia) and no prediction model has been validated in prospective     multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model     (Nomat) has been developed, common to all atypical lesions, which can predict the presence of     a BC at excision surgery (risk of concurrent BC). This model is based on the age of the     patient, the disappearance of radiographic abnormalities (microcalcifications in general)     after the biopsy and initial radiological lesion size. This model has good performance with     an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of     20%, negative predictive value was 90%, and this model would have prevented the surgery in     51% of patients (low risk patients by model). It is essential to validate this model by     forward-looking and in different centers to ensure its relevance.      This is a multicenter prospective validation of the model on 300 patients operated for     atypical lesions in 21 centers. All patients with atypical breast lesions have a routine     surgery. The clinical data, imaging and histological data will be collected prospectively.     The main objective of this study is to validate the model Nomat.   "
58214|NCT02523599|"     This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled     efficacy and safety study of postoperative pain in adults who are scheduled for unilateral     inguinal hernioplasty via open laparotomy (tension-free technique).      Patients will assess their postoperative pain intensity (PI) using an 11-point numerical     rating scale (NRS) from 0 hour through 72 hours postoperatively.      The expected maximum study duration for each patient will be up to 60 days, including a     maximum 30-day screening period, the day of surgery and implantation, and a 30-day post     implantation period including treatment and follow-up.   "
58215|NCT02523586|"     The intent of this study is to determine the difference in pharyngeal oxygen concentration in     patients who have a natural airway (not intubated) using commonly available oxygen delivery     systems.      The investigators will test the hypothesis that oxygen concentration during the period of     inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high     flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration     at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask,     non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit.      A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered     clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%.     With a significance criterion of 0.05, 10 subjects would provide more than 90% power to     detect a mean difference of 10%.   "
58219|NCT02523534|"     This is an electrogram mapping study that tests the ability of a new signal processing     technique called electrogram morphology recurrence mapping to locate drivers in participants     with atrial fibrillation. This study will also test the hypothesis that there are     non-invasive markers that can predict driver location. Electrogram mapping will be performed     in participants undergoing ablation for persistent atrial fibrillation. These participants     will have a cardiac MRI and 12-lead ECG prior to the ablation procedure.   "
58220|NCT02523521|"     The purpose of this study is to determine the effects of a physical activity program for     children with Bronchopulmonary Dysplasia.   "
58221|NCT02523508|"     Previous studies have shown that peripheral muscles weakness or inhibition is related to     spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle     weakness. The purpose of the study was to assess the effect of spinal mobilization on the     maximal muscle strength of the hip flexors and motor function.   "
58222|NCT02523495|"     Through clinical observation and data statistics, conclude the clinical outcome of target     therapy in metastasis colorectal cancer and explore some biomarkers that relate to target     therapy.   "
58223|NCT02523482|"     The study objectives are: to validate the subsets of Screening Tool of Older People's     Prescriptions (STOPP) and Screening Tool to Alert Right Treatment (START), or STOPP/START     criteria, and Beers criteria applicable to HAD by comparing their performance when applied to     clinical and HAD for the same patients, and, using clinical data, to compare the performance     of the full STOPP/START and full Beers criteria with each other.   "
58224|NCT02523469|"     The purpose of the study is to define the safety and tolerability of this drug combination.     The study will also define the response rate of patients with advanced and unresectable     NSCLC.   "
58225|NCT02523456|"     Rationale: Early detection and timely interventions are important determinants of clinical     outcome in people with acute illness. Adverse outcomes including unplanned transfer to     intensive care (ICU), cardiac arrest and death are usually preceded by acute physiological     changes manifesting as alterations in vital signs. Usage of early warning scores (EWS) based     on bedside vital sign observations may help early detection, improve outcome of patients and     reduce healthcare cost.      EWS which are effective in predicting deteriorating patients developed in high income     countries have been shown to lose sensitivity and specificity when applied to a low income     setting. It is imperative to explore the usefulness of EWSs in Sri Lanka. If the results are     positive, widespread adaptation of these scores can significantly contribute to improved     patient outcome, better utilization of ICU services and cost effective healthcare provision.      Objectives: To describe the demographic characteristics of cardiac arrest patients and the     availability of physiological variables for calculation various EWSs in DGH, Moneragala To     validate an early warning score suitable for patients at DGH, Moneragala To examine the     effectiveness of the selected EWS at improving pre-defined patient outcomes      Proposed methodology:      Study I: All clinical variables and patient characteristics of past two years collected     retrospectively from BHTs. Vital signs and laboratory measurements 24 and 48 hours before     cardio respiratory emergency and at admission to hospital will be extracted. The availability     of variables required for the calculation of various EWSs will be noted.      Study II: All consecutive inpatient admissions for three months to all units except intensive     care unit at DGH, Moneragala will be included to the study, prospectively. Data will be     collected from bed head tickets using pre-defined data sheets by nominated medical/ nursing     officers daily. Demographic details and physiological data will be recorded on admission to     ward. Physiological data for seven EWS will be collected twice daily by these medical/nursing     officers.      Study III: Training will be given for the staff to identify patients getting worse using the     newly validated EWS. The outcome of this will be measured with information obtained from     Study II.      Ethical clearance obtained from the Ethics review Committee of the Faculty of Medicine,     University of Colombo (EC-15-034).   "
58226|NCT02523443|"     The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is     a better method for managing pain after liver resection compared to patient-controlled     analgesia (IV PCA). Currently, the standard pain control method for liver resection patients     is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a     day to day basis after liver resection.   "
58227|NCT02523430|"     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional     therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.   "
58228|NCT02523417|"     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional     therapy using digital subtraction angiography（DSA）for breast cancer.   "
58229|NCT02523404|"     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional     therapy using digital subtraction angiography（DSA）for lung cancer.   "
58230|NCT02523391|"     The purpose of this study is to compare the pharmacokinetics of capsule and tablet     formulations of TA-8995 in healthy male subjects aged 18 to 55 years.   "
58231|NCT02523378|"     The goal of this research study is to learn how easy participants think it is to complete a     symptom questionnaire.   "
58232|NCT02523365|"     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional     therapy using digital subtraction angiography（DSA） for cervical carcinoma.   "
58233|NCT02523352|"     Aim of this study is to better understand pathophysiology of the alteration of respiratory     mechanics and cardiovascular function in obese volunteer subjects. The investigators plan to     test this hypothesis with a physiological, interventional study conducted on volunteers at     the magnetic resonance (MR) suite at Massachusetts General Hospital.   "
58234|NCT02523339|"     The purpose of the study is to test if oxygen saturation in retinal vessels is correlated     with clinical parameters, such as visual acuity, central retinal thickness and presence of     neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The     study will not entail change in treatment of the disease.   "
58235|NCT02523326|"     Objective The aim of this study was to test a protocol for the extraction of high quality     genomic DNA from saliva samples obtained with mouthwash and taken from patients with     periodontal disease.      Materials and methods Saliva samples were taken from 60 patients, then stored at room     temperature. DNA extraction was carried out at distinct post-sampling times (10, 20 and 30     days). Evaluation of genomic DNA was performed with spectrophotometry, electrophoresis, and     PCR genotyping and sequencing.   "
58236|NCT02523313|"     This is a prospective, double-blind placebo-controlled, multicenter, randomized phase II     trial testing the adjuvant immunotherapy with Nivolumab plus Ipilimumab Placebo or Nivolumab     plus Ipilimumab versus Double Placebo Control as a post-surgical/post-radiation treatment for     stage IV melanoma with no evidence of disease (NED).   "
58237|NCT02523300|"     To explore the potential prognostic effect of glucocorticoid on the postoperative     aorta-related adverse events after aortic dissections patients underwent thoracic     endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given     within 2h after TEVAR.   "
58240|NCT02523261|"     Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high     scientific level as the reference treatment of cerebral infarction associated with proximal     cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time     a major decrease (-35%) of disability related to severe cerebral infarction and reduction in     mortality. These studies only used thrombectomy devices called stent retriever for obtaining     recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014,     2015). This criterion recanalization is important because it largely determines the     functional prognosis of patients with severe cerebral infarction (Khatri, 2014).      These results are exciting but we can do even better. Indeed, already new thrombectomy     devices are available with a special interest for ADAPT (A Direct Aspiration First Pass     Technic). This distal suction system, with a high level of endovascular navigability,     provides high recanalization rates (> 90%), low morbidity, with a synergistic effect with     stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been     assessed in a randomized controlled trial.      We have previously conducted a comparative observational study between two recanalization     strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever.     The interventional neuroradiologist could, in case of recanalization failure with the     Solitaire system, used another thrombectomy material left to the operator's choice. 244     consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France)     admitted for a cerebral infarction associated with proximal occlusion were included. This is     so far the largest series of patients with ADAPT system. The complete recanalization rate was     84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral     presentation at the European Stroke Organization, April 2015). Our research aims to show that     a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT)     is superior that the use of a stent retriever.   "
58241|NCT02523248|"     The aim of this randomized control study is to evaluate the effect of tonsillectomy with or     without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.   "
58242|NCT02523235|"     Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for     lower extremity post-operative pain control, specifically for total knee arthroplasty and     foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for     postoperative analgesia may be placed at various locations along the target nerves.     Investigations of single-injection peripheral nerve blocks suggest that the onset of the     block might be faster with one location over the other; but, the success rates are     equivalent. However, remaining unknown is whether there is an optimal location to place a     perineural catheter as part of a continuous peripheral nerve block.   "
58243|NCT02523222|"     This will be a quasi-experimental study comparing blood glucose values 30 minutes after     feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal     hypoglycemia.   "
58244|NCT02523209|"     While the duration of renal transplant function has increased over the last decade kidney     transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general     population. Fracture risk remains increased despite the improvement of immunosuppressive     therapies (IST) that allowed the reduction of steroid administration. Potential explanations     for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that     occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2)     that kidney transplanted patients are older and older (14% of kidney transplanted patients     were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST,     besides steroid, may have deleterious effects on bone and 4) that secondary     hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus,     the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains     insufficiently characterized. Despite these data, and contrarily to what is done for patients     candidates for cardiac transplantation, there is no general consensus for performing bone     evaluation before kidney transplanted . Thus it's necessary to individualize the management     of bone fragility and prevent fractures according to strategies that remain to be defined,     provided that patients at risk are better detected.   "
58245|NCT02523196|"     This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt     (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to     Hepatic Venous Pressure Gradient testing in patients with liver disease.   "
58246|NCT02523183|"     Many families of children with medically refractory epilepsy are choosing to use medicinal     cannabinoids (MCBD) as an adjunctive alternative treatment option. The safety, tolerability     and efficacy of these products are not known. The primary objective of this study is to     determine how the use of MCBD affects children with medically refractory epilepsy in an     observational study. Measures of evaluation to be used will include: laboratory values,     developmental measures, seizure diaries and serial electroencephalographic (EEG) recordings.   "
58247|NCT02523170|"     A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in     patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided     fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited     sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by     standard surveillance. This part of the study will recruit 60 patients.   "
58248|NCT02523157|"     The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which     aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.   "
58249|NCT02523144|"     Sedation Techniques for children undergoing transthoracic echocardiography (TTE).   "
58250|NCT02523131|"     The main study objective is to determine whether day and night automated closed loop glucose     control combined with pump suspend feature will improve glucose control and reduce the burden     of hypoglycaemia compared to sensor augmented insulin pump therapy alone.      This is an open-label, multi-centre, multi-national, single-period, randomised, parallel     group design study, involving a three-month period of home study during which day and night     glucose levels will be controlled either by a closed loop system combined with pump suspend     feature (intervention group) or by sensor augmented insulin pump therapy (control group).      It is expected that up to 100 subjects, aiming for 84 randomised subjects [42 youth (6 to 21     years), and 42 adults (22 years and older)], with type 1 diabetes will be recruited through     paediatric and adult outpatient diabetes clinics in each of the investigation centres.     Subjects who drop out within the first four weeks of the intervention may be replaced.     Participants will all be on subcutaneous insulin pump therapy and will have proven     competencies both in the use of the study insulin pump and the study CGM device.      Subjects in the intervention group will receive appropriate training in the safe use of     closed loop insulin delivery system and pump suspend feature. All subjects will have regular     contact with the study team during the home study phase including 24/7 telephone support. The     primary outcome is between group differences in the time spent in the target glucose range     from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels during the 12 week free     living phase. Secondary outcomes are HbA1 at the end of treatment period, the time spent with     glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.     Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes.   "
58301|NCT02522468|"     The purpose of this randomized trial is to determine the superiority of utilizing radioactive     seed localization (RSL) over wire-guided localization (WL) for palpable or non-palpable     malignant lesions in patients undergoing breast conservation surgery (BCS).   "
58251|NCT02523118|"     The purpose of this observational study is to find the best measures to define how well a     person with eosinophilic disorder is doing. People with eosinophilic esophagitis (EoE),     eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or     colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for     microscopic analysis. Treatments are then decided based on how the tissue looks. We are     aiming to compare different tissue components such as inflammatory cell types with clinical     symptoms. We want to see if scores on standard questionnaires can give us an idea how well     the person is doing.   "
58252|NCT02523105|"     This study evaluates the use of brain activity monitoring for early identification of     pharmaceutical treatment efficacy and development of depression deterioration events.   "
58253|NCT02523092|"     The objective is this study is to test whether use of Acthar gel in the context of     sarcoidosis will lead to improved symptoms and lung function and correlate with decreased     levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).   "
58254|NCT02523079|"     The aim of the study is to compare the implementation and effectiveness of group and     self-help based cognitive behavioral treatment for insomnia (CBT-I) delivered by occupational     health services (OHS) in a randomized and controlled design (RCT) among different types of     shift workers.   "
58255|NCT02523066|"     Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.   "
58256|NCT02523053|"     The aim of this study is to confirmed the role of intraoperative controlled release     5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with     high risk of preoperative prediction of microvascular invasion.   "
58257|NCT02523040|"     This research study is studying a chemotherapy drug Lenalidomide as a possible treatment for     one of three histiocyte disorders: Langerhans cell histiocytosis (LCH), Erdheim-Chester     disease (ECD), or histiocytic sarcoma (HS).   "
58258|NCT02523027|"     This study will investigate the effect of two oral nutritional supplements (ONS) along with     dietary counseling vs dietary counseling alone on growth among picky eating children from     India, aged > 24 months to ≤ 48 months over a period of 90 days.   "
58259|NCT02523014|"     This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor     GSK2256098 work in treating patients with meningioma that is growing, spreading, or getting     worse. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
58260|NCT02523001|"     The purpose of this study is to test the hypothesis that the function and/or regulation of     urinary aquaporin 2 in hypercholesterolemic humans is affected by standard statin therapy, as     compared with diet alone   "
58261|NCT02522988|"     The purpose of this randomized-controlled, crossover pilot trial is to evaluate the     feasibility, acceptability and effects of a non-deceptive (open-label) administration of     placebo pills for treating cancer related fatigue (CRF). If significant effects are found,     the investigators will later determine if the presence of a COMT Val18Met genotype variant     predicts placebo responses.   "
58262|NCT02522975|"     This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO®     and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The targeted     population is anaemia patients with chronic renal disease who are naive to epoetin treatment     and not yet on haemodialysis.   "
58263|NCT02522962|"     This project comprises a two-arm randomized controlled trial (RCT) complemented by     qualitative research on innovative group-based intervention for people with Multiple     Sclerosis (MS) performed in the primary health care and organized in collaboration with the     services provided by a hospital's outpatient clinic. The RCT will be conducted by Nordland     Hospital Trust, Bodø (NLSH), in collaboration with UiT The Arctic University of Norway (UiT)     and the Norwegian Centre for Integrated Care and Telemedicine, University Hospital North     Norway (NST). The overall purpose of the RCT is to demonstrate whether high-intensity     individualised group-based core stability training (GroupCoreSIT) performed by     physiotherapists (PTs) in the primary health care has effect on balance, walking and     activities of daily living (ADL) in people with MS compared to standard care. Changes in     quality of life and costs will also be studied to conclude whether the intervention is     cost-effective. The qualitative study contains three parts. The first part aims to     investigate users' experiences from participating in the new group intervention and in     standard care. The researchers will particularly focus on reflections regarding content,     feasibility, potential changes in ADL, self-management, and continuity of care. The second     part will investigate how the PTs act and interact with the group while conducting the     intervention, particularly how individualization is carried out, and the PTs' reflections     from participating in the education and performance of the intervention. The third part     explores health professionals' reflections regarding coordination of care in people with MS.   "
58264|NCT02522949|"     This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation     of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of     participants will receive ColdZyme® mouth spray while the other half will receive placebo.   "
58265|NCT02522936|"     This is a randomized placebo controlled trial of the use of Biotene versus no treatment in     women receiving oral oxybutynin for overactive bladder. The primary outcome will be rate of     discontinuation of oxybutynin at 6 month.   "
58266|NCT02522923|"     This study is a randomized controlled trial conducted at two clinical sites. The purpose of     this study is to determine whether patients with musculoskeletal injuries do better by seeing     a primary care provider first versus seeing a physical therapist first. Target enrollment is     150 subjects.   "
58267|NCT02522910|"     This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3     dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY     1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel     in subjects with second- or third-line NSCLC.   "
58268|NCT02522897|"     The purpose of this study is to determine if additional panretinal photocoagulation of     ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and     allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment     following the trea-and-extend scheme.   "
58271|NCT02522858|"     Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on     respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to     prolong the anesthesia time when used with patients undergoing spinal anesthesia. However,     dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose     dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of     anticholinergic agents on vital sign in patients undergoing spinal anesthesia.   "
58272|NCT02522845|"     This study will be looking at the effect of compression therapy in patients having endovenous     treatment for truncal incompetence of their varicose veins using either radiofrequency     ablation (RFA) or endovenous laser therapy (EVLT). Patients will be randomised to either the     compression group (group A) or the no compression group (group B).      The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as     the cost effectiveness of each intervention will be assessed.   "
58273|NCT02522832|"     A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers     in the human viral challenge model.   "
58274|NCT02522819|"     This project is focused on the treatment of obstructive sleep apnea in the acute phase of     stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it     has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke,     on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke     have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is     associated with worse functional outcomes and higher mortality in the post-stroke period.     Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to     aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially     reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary     treatment for obstructive sleep apnea.      Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of     CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one     randomised trial has provided the means to document neurological improvement at mid term (1     month) in a targeted population.      Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of     ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at     the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate     the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.   "
58275|NCT02522806|"     In spite of all progress realized in the field of assisted reproduction the pregnancy rate by     In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.      Different causes may account for these failures and that, during all stages of pregnancy.      Recent studies have investigated an essential step in fecundation : uterine receptivity. Some     teams have shown that a lot of immunological factors would have very significant in this     step, by them possible expression in this process. Other studies looked at genes modulation,     essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy     (EB). The last findings published on this subject, but after 2 IVF failures, are most     encouraging because the pregnancy rate for these teams after just endometrial local injury     (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused     on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest     with results, suitable treatment for each patient (ongoing study).      EB is quick, easy, make in a simple consultation and with a low cost, contrary to     immunological study, which depend of ultra-specialized laboratories and therefore with an     important cost.   "
58276|NCT02522793|"     1. Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and          normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the          optical measurements could be used to survey for and delineate the extent of          malignancies in a noninvasive manner.        2. Study activities and population group: Competent adults with a clinically suspicious          skin lesion who are undergoing a biopsy as part of their routine care. For those who          agree to participate, the sterilized portable optical spectroscopic probe will be used          to measure diffuse reflectance on the lesion of clinical interest.        3. Data analysis and risk/safety issues: The optical spectrometer does not breach any skin          defense barrier. As this study involves noninvasive optical measurements of tissues, no          significant safety concerns are anticipated. Qualitative analysis will be performed to          describe whether there is correlation between spectroscopy measurements and pathologic          diagnosis. A variety of correlative statistics will be explored to determine if there          are relationships found that can justify a larger study   "
58277|NCT02522780|"     The purpose of this trial is to investigate the safety and efficacy of mesalamine 2 g     extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic     remission in subjects with UC. The duration of treatment for each subject will be 6 months.   "
58278|NCT02522767|"     The purpose of this trial is to investigate the safety and efficacy of mesalamine for the     induction of clinical and endoscopic remission in subjects with active, mild to moderate UC.     Subject will receive 4 g extended release granules (sachet) once daily.   "
58279|NCT02522754|"     A study to compare multiple dosage regimes of a protesomal intranasal vaccine.   "
58280|NCT02522741|"     The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic     stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for     mothers receiving preventive services. The study intervention is adapted from Skills Training     in Affective and Interpersonal Regulation (STAIR). The investigators expect that the adaption     (Parenting STAIR) has the potential to prevent child maltreatment as well as improve maternal     and child well-being by reducing the effects of maternal PTSD and depression on parenting.      The investigators plan to recruit mothers with high levels of trauma-related symptoms from     preventive service agencies, and invite them to participate in the study. This study is a     single group design, and data will be collected pre-treatment, post-treatment, and 12-week     follow-up.   "
58281|NCT02522728|"     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective     randomized clinical trial.   "
81038|NCT02225210|"     This study was designed to observe the effects of dexmedetomidine on delirium and     haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of     dexmedetomidine.   "
58282|NCT02522715|"     This phase I/II trial studies the side effects and best dose of cabazitaxel when given     together with enzalutamide in treating patients with prostate cancer that has spread to other     places in the body (metastatic) and has not responded to treatment with hormones     (hormone-resistant). Drugs used in chemotherapy, such as cabazitaxel, work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Androgen can cause the growth of prostate     cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the     use of androgen by the tumor cells. Giving cabazitaxel together with enzalutamide may work     better in treating metastatic, hormone-resistant prostate cancer.   "
58283|NCT02522702|"     The aim of the study is to develop a computer program which is able to distinguish between     adenomatous and non- adenomatous polyps on the basis of optical features of the polyps. Still     images of polyps (< 10 mm of size) will be collected during routine colonoscopy procedures.     All polyps will be resected endoscopically so that histopathological diagnoses (gold     standard) can be notified.      In the validation phase of the study a computer program will be established which aims to     distinguish between adenomatous and non- adenomatous polyps on the basis of optical features     derived from still images. The program will operated using the the random forest learning     method. Afterwards, in the testing phase of the study, still images of 100 polyps (not used     in the validation phase) will be presented to the computer program. The establishment of a     well- functioning computer program is the primary aim of the study.   "
58284|NCT02522689|"     It is aimed to evaluate the treatment results, rates of success and complications, and injury     given to the kidney by measuring preoperative and postoperative blood and Cystatin C levels     in patients with kidney stones smaller than 2 cm who will undergo either ultra-mini     percutaneous nephrolithotripsy (PCNL) or micro PCNL.   "
58285|NCT02522676|"     It is aimed to evaluate the treatment results, rates of success and complications, and injury     given to the kidney by measuring preoperative and postoperative blood urea, creatinine,     Cystatin C and Netrin-1 levels and urine Cystatin C and Netrin-1 levels in patients with     lower pole or renal pelvis stone(s) undergoing either one of the treatment modalities     including conventional percutaneous nephrolithotripsy (PCNL), mini PCNL, ultra-mini PCNL,     micro PCNL, retrograde intrarenal surgery (RIRS) and extracorporeal shock wave lithotripsy     (ESWL).   "
58286|NCT02522663|"     Aortic Valve Replacement (AVR) surgery for aortic valve disease continues to increase in     numbers. With better surgical techniques and equipment, also older patients can be operated     on, resulting in an growth of the older population. AVR is characterized by high rates of     hospital readmissions, resulting in suboptimal care planning and higher health care costs.     Hence, it is important to develop strategies to reduce hospital readmissions following AVR.     The purpose if this study is to develop and test the efficacy of a 24/7-phone support in the     reduction of readmissions after AVR treatment. Secondary outcomes are a reduced level of     anxiety, less depressive symptoms and a better health related quality of life.   "
58287|NCT02522650|"     This cross-over study is designed to test the hypothesis that amiloride will reduce urinary     protein excretion and protect the kidney from rapid progression in proteinuric kidney     disease.   "
58288|NCT02522637|"     International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate     COPD patients looking at the work setting, programs and frequency of training sessions in an     outpatient program of rehabilitation. However, a new population of respiratory patients is     growing: these are more serious and older patients, with several comorbidities and recurrent     hospitalizations. In this population no guidelines are available to describe the optimum     prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In     this kind of patients, only few studies are available on the overtraining risk. The aims of     the current study are:        1. To detect and compare the response in terms of endurance of two endurance training          programs with different time-frequencies (1 session / day versus 2 sessions / day)          during 30 days of in-hospital admission to a pulmonary rehabilitation center        2. To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and          respiratory muscle strength, quality of life and psychological and functional impact of          the disease.   "
58289|NCT02522624|"     The overall purpose of the study is to better understand how the investigators previously     developed decision support (DS) tool can help people make decisions about health insurance     plans available through the federal exchanges created by the Affordable Care Act (ACA). The     investigators will evaluate the DS tool compared to the federal government website. The     investigators will also evaluate the feasibility of disseminating this tool. There are two     primary aims to be completed in this project: (1) examine the reach and effectiveness of the     health insurance DS tool; and (2) collect stakeholders' feedback to improve the likelihood of     implementation of the DS tool.   "
58290|NCT02522611|"     Background:      Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to     anxiety, depression, and reduced mobility and quality of life. Researchers believe a research     drug called resiniferatoxin (RTX) may be able to help.      Objective:      To learn whether RTX is safe and can reduce cancer induced bone pain.      Eligibility:      People ages 18 and older with CIBP that is not relieved by standard treatments      Design:      Participants will have up to 6 outpatient visits over about 7 months. These will include:      Medical history      Physical exam      Blood and urine tests.      Thermal testing: a disk placed on the skin to test ability to sense temperature in and around     the area of pain      Chest x-ray      EKG: stickers are placed on the chest to measure heart signals      ECG: measures electrical activity of the heart      Participants will have 1 inpatient visit lasting 2-4 days. This will include:      Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray     contrast.      A needle is passed through the skin of the back to inject the RTX.      Participants will keep a log of the pain medications they take after surgery.      Participants will be called 1 week and 2, 3, and 4 months after the injection.      Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after     the injection.   "
58320|NCT02522221|"     TACT is a real world randomized controlled trial of tecarfarin, a novel vitamin K     antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two     groups of subjects who require chronic oral anticoagulation for a broad panel of indications.   "
58291|NCT02522598|"     VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity     inhibiting GlyT2 and 5HT2A simultaneously. These target receptors have been known to play     important roles in induction and transmission of pain signals. There have been many efforts     to develop selective drugs to treat pain, but usually unsuccessful due to the lack of     efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected     to be a dual-target drug, demonstrated having a potential synergism between GlyT2 and 5HT2A     to maximize an antinociceptive effect in the in vivo animal models. In Phase 1 conducted     among healthy subjects, safety and tolerability were confirmed. Phase 2 was designed as a     randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy     and safety of the analgesic drug VVZ-149 injection.   "
58292|NCT02522585|"     The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia     grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and     ki-67 immunohistochemical staining and to the expression of NK cell receptors.   "
58293|NCT02522572|"     The primary objective of this study is to conduct a proof of concept pilot study that will     provide a preliminary evaluation of the safety of plerixafor alone or in combination with     bortezomib on plasma cell mobilization, Human Leukocyte Antigen (HLA) antibody levels and     toxicity profile in sensitized patients awaiting kidney transplantation.      The secondary objective of this study is to conduct additional analyses of the study regimen     on HLA antibody levels using multiple different assays and statistical analysis.   "
58294|NCT02522559|"     Herbs and spices offer one potential solution to the recent decline in children taking school     lunch because they can increase the palatability of foods without adding salt and fat.     However, there is currently limited evidence on how to successfully integrate herbs and     spices into the school lunch menu. Developing evidence-based methods to teach school     cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs     and spices is a research priority. The investigators hypothesize that herbs and spices can be     used to increase acceptance, intake, and participation in the school lunch program among 6th     - 12th grade students from Central Pennsylvania.   "
58295|NCT02522546|"     Pneumococci are bacteria which can cause serious and potentially life threatening illnesses     like meningitis and blood poisoning.      Pneumococcal vaccines (PCV) have been given in the national immunisation schedule since     2006.Carriage studies allow assessment of how the strains in the nose change over time, in     that by clearing some strains away which other strains take up those niches in their place     both in children and in their close/household contacts. This helps to inform the best use of     the vaccines available and for future vaccine development and which strains would be useful     to include.   "
58296|NCT02522533|"     Frailty has been associated with poor acute and long-term outcomes after major surgery. We     recently determined that nearly 70% of patients undergoing major thoracic surgery are     pre-frail or frail. We are interested in assessing whether a strength training intervention     for frail or pre-frail patients has an impact on surgical decision making and on surgical     outcomes.   "
58297|NCT02522520|"     Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women     are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other     cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is     71 years. Improved treatment has increased the number of survivors with an expected 5-year     survival rate of 50-60%. Characteristic of this group of patients is that at the time of     diagnosis they often live with comorbidities and have limited leisure time physical activity.      There is evidence that rehabilitation in the form of physical exercise for cancer patients     after their initial treatment has a positive effect on a number of physical and psychological     parameter such as health-related quality of life, physical capacity and physical function,     fatigue, anxiety and depression. However, the most frequently studied diagnosis group is     women with breast cancer. Until now only few studies have evaluated the effects of physical     activity among colorectal cancer patients receiving chemotherapy      The purpose of this study is: to examine the effect of two different training initiatives -     12 weeks progressive, high-intensity training versus low intensity exercise intervention - on     physical, emotional and social habitus, in sedentary patients with colorectal cancer during     adjuvant chemotherapy.      The hypothesis of the study are: 1. That both interventions will show a positive association     between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen     uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary     colorectal cancer patients undergoing adjuvant chemotherapy.      Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have     self-reported physical activity level below the national recommended levels (less than 150     min/week of moderate leisure time physical activity, and exercises at least 20 minutes of     strenuous physical activity twice a week).      Benefits and risks of participating: Possible benefits of the interventions: to reduce     treatment related symptoms and side-effects, increase vitality and well-being and promote     lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy.     At participation in the interventions minor sports injuries may occur.   "
58298|NCT02522507|"     Despite the strong business case of hiring people with disabilities, a significant proportion     of youth with disabilities leave high school and neither work nor continue their education     and are unprepared to meet the demands of a work environment. Although youth with     disabilities have much to gain from employment readiness programs, they are often excluded     from, or have limited access to school and community vocational programs. One encouraging     approach to address gaps in vocational programming is through peer mentoring, which may     facilitate a smoother transition to adulthood by offering support to enhance coping skills.     Despite the increase in online communities, little is known about their impact on vocational     mentoring for youth with physical disabilities and their parents. The purpose of this study     is to develop, implement and assess the feasibility of an online peer mentor employment     readiness intervention for youth with physical disabilities and their parents to improve     their self-efficacy, career maturity and social support.   "
58299|NCT02522494|"     Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the     prevalence of diabetes at almost 20 percent in VA patients. Poorly controlled diabetes leads     to a number of complications including cardiovascular disease, blindness, amputation, and end     stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as     diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care     is related at least in part to effective communication in medical encounters. This project is     designed to test a video intervention to improve patients' communication behaviors. Providers     will also receive a pamphlet with specific recommendation to improve communication skills.     The project will assess the impact of the training programs on communication and outcomes.     The study is designed to help make patient care more patient-centered, which is one of the     six aims for improvement in the IOM Report, Crossing the Quality Chasm and is a goal of VA     transformation efforts.   "
58300|NCT02522481|"     The purpose of this study is to assess the safety and efficacy of Lumason-enhanced dobutamine     stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border     delineation (LV EBD) at rest and who are scheduled for coronary angiography.   "
58302|NCT02522455|"     This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks     gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants     require less overall pressure from the ventilator than the usual conventional settings used,     with the aim of providing data to construct a larger trial looking at the longer term outcome     of these infants using this type of ventilation in the future.      Many preterm infants at these gestations require assistance from a ventilator due to the     immaturity of their lungs. The lungs of preterm infants are susceptible to damage, especially     if high pressures are needed or prolonged periods of ventilation. There is concern that if     the infant's breathing pattern does not synchronise with the ventilator, this causes     additional distress, longer duration of ventilation needed and increased risk of     complications. Over the past 20 years, a different type of ventilation, known as flow-cycle     ventilation, has been trialed, with limited use in preterm infants. This allows the baby to     determine the duration of breathing in and out and how many breaths they require per minute.     This would help babies to synchronise better with the ventilator, and consequently require     less pressure from the ventilator.      This pilot study is being conducted at St. Mary's Hospital, Manchester. All babies born under     32 weeks gestation, with a stable respiratory effort, will be eligible for consideration for     the study. The study will last no longer than 5 hours and involve the babies receiving     different pressures from the ventilator in flow-cycle mode for 1-hour epochs. Blood gases     after each epoch and continuous ventilator data will be downloaded to assess their tolerance     on the different settings, before being returned to the usual conventional settings used on     the unit. The babies will have continuous monitoring throughout as per standard neonatal     intensive care.   "
58303|NCT02522442|"     The primary objective outcome is the proportion of participants compliant (at least four     hours of use per night for all nights) in the Auto Bilevel group compared to the continuous     positive airway pressure (CPAP) group after 90 days of treatment during the investigation.     Proportion will be calculated using the cumulative number of hours on therapy divided by the     total number of days of the investigation for each participant. The mean and standard     deviation of these mean therapy hours will then be calculated for each arm of the     investigation. Participants with compliance of at least four hours will be classified as     compliant and those with less than four hours will be classified as non-compliant. The     null hypothesis will be rejected if the mean of the primary objective outcome for all     participants in the BiPAP® Auto with Bi-Flex® therapy (auto Bilevel) arm is significantly     greater than that for all participants in the CPAP therapy arm   "
58304|NCT02522429|"     Few neurological conditions are as scientifically mysterious and clinically, legally, and     ethically challenging as disorders of consciousness. To date there exists no standard     intervention for patients suffering from these devastating conditions. The present project is     aimed at evaluating the potential of non-invasive Low Intensity Focused Ultrasound Pulsation     (LIFUP) of thalamus (a key area for the consciousness network) as a neurorestorative     stimulation for those patients. In this study, LIFUP will be performed during two sessions.     The proposed experiment will involve behavioral and paramedical measurements just before and     after each of the two LIFUP sessions in a small sample of patients (up to 15) in order to     evaluate the feasibility of a full scale clinical trial. Outcome measures will be     administered at discharge, 6 months and one year after injury.   "
58305|NCT02522416|"     Corneal topography allows the measure of the radii of curvature and of the thickness of the     cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal     irregularities such as a keratoconus, or too thin corneas which are a contra-indication for     laser refractive surgery.      Several types of corneal topographers are commercially available. Some as the Orbscan(r),     operate by analyzing the image of the patterns of a Placido disk associated with a light     slit, allowing the collection of thousands of points of the anterior and posterior surface of     the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras     which capture images of the whole anterior segment of the eye. The aim of this study is to     compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the     central corneal pachymetry measurements measured pre- and postoperatively.   "
58306|NCT02522403|"     The patients with distal radius fracture treated with immobilization (cast) and percutaneous     pinning it will be to able to participate in this randomized trial. The investigators will be     able to determine if the laser acupuncture is a good therapy for the rehabilitation in this     type of patients. And if they are more comfortable to begin his rehabilitation exercise after     the application of this therapy   "
58307|NCT02522390|"     The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop     and evaluate the open access Nutrition Researcher Cohort for gathering personal health data     from nutrition researchers, including analytical methods, standards and operation procedures,     data infrastructure, ethical and privacy aspects, and governance.      Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound     intake and exposure, biomarkers for food, health and/or disease and health and/or disease     related measurements to study the relation between nutrition, health and development of     disease (on individual level).      In addition, data will be used to develop applications that visualise personal health risks     based for example on (validated) recommendations and applications that predict individual     health risks.      The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort     will be composed of about 250 life sciences employees and students from different,     predominantly European, countries. This allows optimal involvement of participants in shaping     all aspects of the cohort and the ownership of data. We aim to recruit about in total 20 male     and female scientists per participating country.   "
58308|NCT02522377|"     In this proof of concept study, the investigators plan to administer iv ketamine interleaved     with ECT days.      Patients with treatment resistant depression who are deemed to be eligible for ECT treatment     will randomly be assigned to either ketamine or active placebo.   "
58321|NCT02522208|"     This study will investigate cardiovascular parameters using echocardiographic and     pharmacokinetics during a daily dose of BiDil and BiDil Extended Release (XR) compared to a     study drug free day.   "
58322|NCT02522195|"     This study assessed the meal distribution across the day (energy and macronutrient intake)     and its relationship to the nutritional status of nursing professionals.   "
58323|NCT02522182|"     The purpose of the ALLEPRE trial is to compare the benefit offered by a structured, intensive     and fully nurse-led intensive secondary prevention intervention programme with that offered     by standard of care in a high-risk population of patients admitted to hospital because of an     ACS.   "
58324|NCT02522169|"     This clinical trail intends to evaluate interventions based on the Infliximab trough levels     for an individualized therapy adaption for pediatric IBD-patients undergoing     anti-TNF-alpha-therapy. Main aim of the individualized strategy is to attain and maintain     early disease control in order to keep as many patients as possible in disease remission, and     to avoid primary and secondary therapy failure.   "
58309|NCT02522364|"     Postoperative atrial fibrillation and atrial flutter (POAF) is the most common complication     after cardiac surgery requiring intervention or prolonged hospital stay.      POAF is associated with higher mortality and higher risk of thromboembolic events.      However, It is yet unknown whether a now event of postoperative atrial fibrillation is an     indication of a chronic arrhythmic disease - a tendency towards developing recurrent atrial     fibrillation or merely a response to the stress of surgery with not recurrence. This     distinction is critical to determine the appropriate therapy. Since recurred events of atrial     fibrillation (Paroxysmal atrial fibrillation) are associated with long term risk for stroke     and thromboembolic evens patients with PAF are treated with long term anticoagulation.     Missing the long term recurrence of arrhythmia may result in under-treatment and pose a     significant risk of stroke.      Bio-Monitor is a subcutaneous implanted device that automatically detects arrhythmias and     stores electrocardiogram (ECG) recordings. It will enable the detection of atrial     fibrillation over a period of years and allow correct diagnosis and appropriate treatment.      The purpose of the study is to study the long term behavior of POAF, determine the likelihood     of developing paroxysmal atrial fibrillation in patients with POAF and to define the risk     factors for this eventuality   "
58310|NCT02522351|"     The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of     swallowing in patients having dysphagia problems.   "
58311|NCT02522338|"     Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the     kidneys, and its plasma assay reflects the GFR.      Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on     assay plasma cystatin C with that of the MDRD formulas.   "
58312|NCT02522325|"     This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for     cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which     the subjective, physiological and reinforcing effects of cocaine are evaluated during     maintenance on placebo and phendimetrazine.   "
58313|NCT02522312|"     A retrospective analysis of Restasis® benefits in dry eye contact lens patients.   "
58314|NCT02522299|"     The purpose of this study is to evaluate specific alterations in immune cell mechanisms     related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger     ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an     exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment     with GSK2269557 will also be measured using functional respiratory imaging (FRI) and     spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study. The     study consisted of Screening Phase (up to 3 days prior to Day 1), Treatment Phase (Days 1 to     84) and Follow phase (7 to 14 days after last dose). The total duration of the study is 13-14     weeks including the screening visit.   "
58315|NCT02522286|"     This study implements a simple evidence-based patient activation intervention - Ask 3     Questions- augmented by a novel theory-based intervention - Open Communication - aimed at     activating patients and healthcare providers. The goal of this project is to increase patient     and physician's preparedness for more having more questions, expressing differing opinions,     and working collaboratively in making medical decisions that are both informed and responsive     to patients' needs and preferences.   "
58316|NCT02522273|"     A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a     baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is     becoming distressed.      In this situation a blood test can be taken from the scalp of the baby. A high lactate level     in the blood indicates that urgent delivery is required to prevent long-term harm to the     newborn.      SensPoint is a new medical device that measures lactate. It has several potential benefits     over the current method of measuring lactate in that it is a portable hand-held device     (allowing for use in the delivery room), requires a much smaller volume of blood and produces     results more quickly than the current method of measuring lactate.      Before a new device is adopted into clinical practice, it is important that it is first     confirmed that it is accurate and reliable for its intended use. This study will evaluate the     ability of the SensPoint device to accurately and reliably detect lactate in fetal and     umbilical cord blood by comparing its performance to the reference device currently in use.   "
58317|NCT02522260|"     This study on women with breast cancer during and after chemo- and hormonal therapy compares     the effect of different physical training programs on physical and mental well-being and     systemic inflammation mechanisms in blood. In a sub-group of participants, mitochondrial     biogenesis and function and other molecular processes in skeletal muscle biopsies are     studied. The women will be randomly allocated into three different intervention arms, a     control arm with usual care and two different training arms. All participants will respond to     questionnaires and have blood samples and taken and for a subgroup muscle biopsies before and     after the exercise intervention. Participants will be supported to uphold exercise through     collaboration with Friskis & Svettis and followed for 5 years. Some of the women will also be     asked to participate in an in depth interview about the experiences of exercise during     ongoing treatment. This study will contribute to increased knowledge about the type,     intensity and frequency of training that patients with breast cancer benefit most from with     regards to impact on physical and mental wellbeing. This knowledge is of great importance     since experience shows that patients and relatives often seek information about     rehabilitation, self-care and physical activity. The study will also contribute to the     improvement of the patients´ quality of life, ability to return to work, and reduce social     costs, but above all, increase the possibility for development and implementation of     evidence-based rehabilitation of women with breast cancer during and after active treatment.   "
58318|NCT02522247|"     To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.   "
58319|NCT02522234|"     This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627     once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.      The patients received the intravenous administration of the chemotherapy (docetaxol,     doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and     the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24     hours after chemotherapy) each cycle for up to 6 cycles.   "
63437|NCT02455297|"     The primary objective of this study is to assess objective response rate (ORR) in patients     with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate     ibrutinib.   "
58325|NCT02522156|"     Almost one-fifth of US adults are current cigarette smokers. To make further progress in     lowering prevalence, it would help to increase the proportion of smokers attempting to quit.     This application tests a novel approach to motivating smokers to quit, based on an     empirically supported theory of anxiety. The approach uses guided imagery to increase     smokers' sense of urgency about preventing the negative health consequences of smoking.   "
58326|NCT02522143|"     Study Aims/Objectives:      This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to     the unique requirements of students meeting sub-clinical diagnostic criteria for BPD     (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.   "
58327|NCT02522130|"     Different ways of reducing pain during IUD insertion have been explored. So a randomized     study will be conducted to test their role   "
58328|NCT02522117|"     Renal insufficiency is a priority disease in the health system, which may require renal     replacement therapy based on kidney transplantation, which is considered as therapy of     choice. During the procedure of kidney transplantation, the body is subjected to     ischemia-reperfusion damage that generates late complications related to graft function.      Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,     which could be beneficial in kidney transplantation.   "
58329|NCT02522104|"     The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and     renal failure requires a specific monitoring and dose adjustment in order to remain within     the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For this     reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in     normal-renal function sickle cell patients to those of patients with glomerular     hyperfiltration or moderate renal failure.   "
58330|NCT02522091|"     Investigators propose in this study to evaluate prospective memory (MP) in all its complexity     as well as the processes, cognitive and brain, the underlying. Specifically, investigators     propose to evaluate the evolution of the MP during normal aging and Alzheimer's disease (AD)     to identify the cognitive and brain processes underlying this development. To do this, this     study will have to include healthy subjects, 18 to 95 years, patients with Mild Cognitive     Impairment (MCI) and patients with probable AD. All participants will undergo a series of     examinations, both neuropsychological and brain imaging.   "
58331|NCT02522078|"     This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine     evacuation increases the dilatation of uterine cervix compared to dry misoprostol   "
58332|NCT02522065|"     The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating     part of the condition. Current methods to evaluate this impairment rely on subjective     examinations. The investigators seek to develop an objective assessment of motor deficits by     monitoring the participants natural interactions with a keyboard (on a computer or smart     device). This approach provides a window to how the brain behaves during typical daily use of     these devices, i.e. writing a report, sending an email or any other task performed on a     digital device and thus has the potential to be used easily and regularly. (Importantly, the     data gathered are non-sensitive and based only on timing information).      PD participants will be recruited during outpatient visits to PD clinics throughout the     Madrid metropolitan region. General entry criteria will be those patients who are scheduled     to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact     on participants' standard clinical management other than by asking the participants to type     for 15 minutes at each of 3 clinic visits, and installing the investigators proprietary     software on their home computer. This software will collect keystroke data alone. (None of     the actual information about what is being typed will be collected.) The keystroke data     collected will be analyzed and compared with standard clinical metrics of therapeutic     response, as well as the in-clinic typing data.   "
58333|NCT02522052|"     Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large     proportion of patients with established disease have persistent high disease activity in     spite of existing effective pharmacological treatment. Improved treatment is thus urgently     needed, including alternative treatments in addition to optimal pharmacological therapy. The     main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis)     could decrease inflammation and disease activity in patients with established RA. A secondary     goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this     diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to     look at genetic polymorphisms in relation to long chain polyunsaturated fatty acids (LCPUFA)     and inflammatory markers.   "
58334|NCT02522039|"     Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol     in healthy subjects. The pupillary constriction is compared to no drug.   "
58335|NCT02522026|"     Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as     well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined     regarding different clinical and blood/ sputum derived biomarkers at the investigators'     research center. This observation study will follow-up/re-examine all available subjects     regarding disease course and treatment changes after 3 years (+/-6 months) for the     investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease     progression. In addition, biobanking of respective biosamples for potential future COPD     biomarker research will be conducted.   "
58347|NCT02521870|"     This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety,     tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections     in combination with intravenous pembrolizumab in patients with metastatic melanoma or     recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).      Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or     intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with     metastatic melanoma.      Phase 2 of this study will consist of 4 expansion cohorts to further evaluate the efficacy     and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC     populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be     recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy     naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.   "
58348|NCT02521857|"     This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS     5461.   "
58336|NCT02522013|"     Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its     clinical manifestations are pain in the forehead and the occipital region, or diffuse     headache. The pain is dull or fluctuating, becoming worse when standing and better when lying     down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss,     photophobia, and nausea, which cause great suffering to the patients1. According to     epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture     suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for     PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and     the application of an epidural blood patch. The efficacy of theophylline has been proven in a     placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of     200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were     significantly different compared with those of the placebo group5. At present, the clinical     application of theophylline has been replaced by aminophylline and doxofylline, and it is     difficult to purchase theophylline in most hospitals in China and other countries.      The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a     prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and     safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients     were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or     sterile isotonic saline.The investigators estimate that this trial will demonstrate that an     IV injection of aminophylline could be the preferred method for the clinical treatment of     PDPH.   "
58337|NCT02522000|"     Functional dyspepsia (FD) is a heterogeneous disorder with multifactorial pathophysiology.     Patients with FD have visceral hypersensitivity to mechanical and chemical stimuli. Several     previous studies have described an increased chemosensitivity to oral capsaicin ingestion.     Capsaicin is a natural agonist of TRPV-1 receptors present on afferent sensory neurons.     Activation of the TRPV-1 receptor by capsaicin or other agonists results in the release of     several neuropeptides (i.e. substance P, somatostatin). Besides, increased duodenal     permeability and disruption of tight junction structure in FD patients compared to healthy     volunteers has been reported in a recent study. In this observational study investigators     will evaluate the role of the TRPV-1 neuropeptide pathway in patients with functional     dyspepsia and healthy controls.   "
58338|NCT02521987|"     The purpose of this study is to determine if there is a difference in pain perception by     participants when the assistant port size varies by 50% (8 mm to 12 mm).   "
58339|NCT02521974|"     Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE     recommendations at the time of writing this protocol. After this cessation of OPV2,     stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future     outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low population     immunity. Research is ongoing to develop vaccines that are genetically more stable than the     currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and     genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio     vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is     performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability     endpoints of mOPV2 in children aged 1 to 5 years and in infants approximately 18 weeks of     aged vaccinated with bOPV-/IPV for better understanding of the stockpile use of this vaccine,     and for comparison with any potential new polio vaccine with a type 2 component in the     future.   "
58340|NCT02521961|"     This randomized clinical trial studies a support group program in improving quality of life     in underserved urban Latina breast cancer survivors. A psychosocial support group program may     help reduce distress and improve health-related quality of life in underserved urban Latina     breast cancer survivors.   "
58341|NCT02521948|"     The purpose of this study is to evaluate the safety and performance of the MANTA Vascular     Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular     procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite     Europeenne--European Conformity) and other regulatory submissions. The study will assess     whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after     interventional procedures.   "
58342|NCT02521935|"     Purpose: To compare complete denture outcomes between conventional and digital denture     fabrication processes.      Participants: Sixteen edentulous adult patients in the University of North Carolina School of     Dentistry Student Clinic who are seeking removable complete dentures.      Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one     using the conventional process (A) and the other using a digital process (B). Variability     will be assessed by the research team, the treating dental students, an independent     prosthodontist, and the patients through quantitative measures. Case selection and results     analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.   "
58343|NCT02521922|"     To assess the feasibility and usability of the VSP System in the in-patient hospital setting     to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be     incorporated into the study site's Information Technology infrastructure.   "
58344|NCT02521909|"     The purpose of this study is to compare the accuracy of different apex locators. Before root     canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the     root canal and to locate its opening at the tip of the tooth's root (called the apical     foramen). A root canal is the space inside the root of a tooth. If the tissue within the root     canal becomes infected, dentists may perform root canal therapy.   "
58345|NCT02521896|"     The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in     facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal     atrial fibrillation and persistent atrial fibrillation (AF). The study will be a prospective,     single-center, non-randomized investigation.   "
58346|NCT02521883|"     The aim is to investigate the safety and effectiveness of transcranial Direct Current     Stimulation (tDCS) in patients with moderate to severe major depression compared to patients     treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.      This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.   "
58867|NCT02515032|"     SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary     weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective     is to study the safety and tolerability of Nutrifriend Cachexia.   "
58349|NCT02521844|"     This is a Phase 1A/B study consisting of two parts. Part A is a non-randomised, open-label,     sequential evaluation of the safety, pharmacokinetics, MTD, and RD of ETC 1922159 in patients     with advanced or metastatic, or unresectable solid malignancies, for whom no approved     treatment option or standard of care is available. Dose escalation, with the goal of     identifying the MTD and RD, will be guided by an oCRM model with a cohort size of one     patient.      Part B will be a non-randomised, non-comparative, open-label evaluation of the safety and     tolerability of the RD of ETC 1922159 in patients with advanced or metastatic, or     unresectable solid malignancies, for whom no approved treatment option or standard of care is     available, with a molecular phenotype that is expected to make them sensitive to PORCN     inhibitor treatment.      It is anticipated that the study will take approximately 34 months to complete (approximately     22 months for Part A and approximately 12 months for Part B).   "
58350|NCT02521831|"     Significant concern regarding the safety of general anesthesia in children has arisen due to     myriad animal studies suggesting neurotoxicity of commonly used anesthetic agents.     Inflammation of the central nervous system after anesthesia may have a significant role in     the pathogenesis of anesthetic-induced neural injury. To evaluate this hypothesis, the     investigators propose to randomize healthy infants undergoing elective surgery to one of two     anesthetics: 1) spinal anesthesia only; or 2) general inhalational anesthesia with     isoflurane, laryngeal mask airway (LMA) or endotracheal tube (ETT), and single-shot caudal     block. Primary endpoint will be serum inflammatory biomarkers and transcriptome analysis and     secondary endpoint will be neurocognitive outcome at 6 months and 1 year.   "
58351|NCT02521818|"     This trial seeks to establish the feasibility of implementing a ketogenic, modified Atkins     diet (MAD) to older adults with mild cognitive impairment (MCI) or early Alzheimer's disease     (AD) living in the community. A secondary aim is to determine whether adherence to the MAD     results in better cognitive test scores than adherence to a non-ketogenic control diet. A     final aim is to determine the role of apolipoprotein E (ApoE) genotype in participants'     response to the MAD. Participants will be randomly assigned to a 12-week trial of either the     MAD or a placebo diet based on the National Institute on Aging's recommendations for senior     nutrition.   "
58352|NCT02521805|"     A randomized cross-over meal study will investigate the effects of protein quality and a     combination of dietary fibre and protein on appetite regulation.      The study will use basic measures of ad libitum energy intake and visual-analogue scales of     appetite (study A). A sub-study (study B) will additionally include blood collection from 15     of the 40 participants to investigate biological markers targeted satiety.      The study days will be conducted at least one week apart to eliminate carry over effects. In     the sub-study, the study days will be at least two weeks apart due to blood collection.   "
58353|NCT02521792|"     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict     movement by locking joints leading to cumulative loss of function and disability. Mouse     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists     such as palovarotene to prevent HO following injury. This 36-month study will evaluate the     long-term safety and efficacy of episodic treatment with palovarotene for flare-ups in FOP     subjects who successfully complete two flare-up treatment periods (6 weeks duration) and two     follow-up periods (6 weeks duration) in Study PVO-1A-202.   "
58354|NCT02521779|"     The purpose of this study was to determine the effect of different dietary fats (saturated or     unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The     investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase     postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial     endotoxemia.Participants were recruited via email and randomized to treatment meal in this     single-blind, cross-over study. Each test session participants reported to the laboratory     right away in the morning. An indwelling catheter was inserted into the participant     non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant     was then provided with one of four test meals (a porridge-type meal containing a different     dietary fat), which they ate in entirety within 15 minutes. The participants remained in the     laboratory for the next five and a half hours and were not allowed to consume any food or     drink except water. During this time, further blood draws were taken at intervals of one hour     for a total of five hours after the consumption of the test meal. Collected blood was     processed on-site and the serum fraction collected and tested for endotoxin, inflammatory     biomarkers, and metabolites.   "
58355|NCT02521753|"     Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age     women. PCOS is usually characterized by an excessive androgen production, menstrual     irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying     degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for     these patients. Metformin has proven to be useful in IR and is frequently used in PCOS.     However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon     rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have     been used in other IR states and may be useful in PCOS. The aim of this study is to asses the     efficacy of these alternatives in obese PCOS patients.   "
58356|NCT02521740|"     Providing care for a disabled elderly may represent a risk for the health of the caregiver.     The objective of the study is to assess the impact of caregiving in terms of clinical and     biological markers in relation to disability and cognitive impairment.   "
58381|NCT02521415|"     This single center, randomized control, double blind trial will prospectively examine the     feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain     control in the pediatric emergency department setting. The investigators hypothesize that IN     ketamine may provide a safe and effective alternative to IN fentanyl for children with     suspected, isolated extremity fractures.      Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires     analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the     emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.   "
58357|NCT02521727|"     The risk of CRC in families of patients with CRC is well established, but it is less     well-defined for families of patients with adenomas. Screening recommendations to families     when an index subject has an adenoma on colonoscopy are not clear. Previous studies     demonstrating an increased CRC risk in close relatives of subjects with adenomas were mostly     limited by the lack of a suitable comparison group, did not offer colonoscopy to all     relatives or did not have verification on true status of adenoma history in the relatives. A     systematic review has reported that most studies cited for risk of CRC in relatives with     adenomas have not addressed the intended question. Currently International guidelines     recommended screening colonoscopy in close relatives and at a younger age when there is a     proband with an adenoma, however this recommendation has not been fully supported by all     societies due to the lack of robust evidence. This gap in knowledge highlights the need of     well-designed and adequately powered studies to estimate the risk of colorectal neoplasms in     subjects who have first-degree relatives with adenomas.      Up to 30% of average risk asymptomatic individuals 50 years or older will have at least one     adenoma. Based on current guidelines, nearly half the population will be counseled to undergo     a colonoscopy from 40 years old based on a positive family history of adenoma. This will have     enormous burden on the healthcare system if screening is implicated in all these individuals.     Secondly, not all adenomas carry the same risk. Large or villous adenomas are associated with     a nearly 70% increased risk of CRC in first degree relatives (FDR) whereas small adenomas may     be associated with a modest increased risk 19. It is therefore important to determine the     risk of colorectal neoplasms in families of subjects with non-advanced adenomas to justify     more intensive screening in these individuals. Investigators hypothesize that first-degree     relatives of patients with non-advanced adenoma have an increased risk of both CRC and     adenomas. Investigators aim to quantify this risk, and to identify other individual patient     or neoplasm characteristics that may contribute to this increased risk. In addition,     Investigators aim to determine molecular alteration profiles of colonic adenoma in siblings     of patients with advanced neoplasm.   "
58358|NCT02521714|"     This study will evaluate the amount of drug that reaches the circulation when a subject takes     the test (liquid) formulation compared to the reference (capsule) formulation. The study will     also examine the effect of a high fat meal on the levels of drug in blood.   "
58359|NCT02521701|"     This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.   "
58360|NCT02521688|"     Investigators have shown the presence of elevated proinflammatory cytokines in amniotic fluid     in patients in preterm labor.However, there is limited and mostly negative evidence that the     elevation of these mediators in gingival crevicular fluid (GCF), and amniotic fluid are     associated with pregnancy complications in periodontitis patients. Thus this case control     study will be conducted to        1. To determine the level of proinflammatory cytokines in gingival crevicular fluid in          women with spontaneous preterm delivery with chronic periodontitis.        2. To investigate the expression of macrophage inflammatory protein-1α in placental          tissues.        3. To assess the possible correlation between chronic periodontitis and preterm delivery.   "
58361|NCT02521675|"     There is no specific recommendations on the adjustments of the insulin treatment in the event     of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often     prefer additional carbohydrates intake rather than the reduction of their insulin doses     because of the lack of specific algorithms.      The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week     of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained     during a week of rest without physical activity.      It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients     practicing an occasional AP.      25 centers involved in this study.      After agreeing to participate in the study, patients will read the information leaflet, ask     questions to the investigator physician and they will date and sign the consent form. The     investigator physician will do the same.      They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in     which they will realize the rest vs DIABRASPORT sessions.      The study will take place in 5 weeks:      During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of     30 to 60 minutes separated by at least 24 hours:        -  moderate activity 3 hours after lunch        -  intense activity 3 hours after lunch        -  activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or          adjustment of the dose of insulin) during the week Baseline and they will use the          Diabrasport algorithm during the week Diabrasport.      Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.      During the week of rest, patients should do no physical activity during the week. They will     be equipped with the Glycemic holter.      Patients will have to fill a food survey the days they practice PA. Between each period, the     patient must respect a period of wash-out for one week at least, during which he will be     asked to not practice physical activity.      Validation of algorithms simple, easy to implement, adaptable by patients, could help to     improve balance metabolic and practice of sport among the T1D.   "
58362|NCT02521662|"     A randomised trial to determine whether e-cigarettes (with and without nicotine) combined     with nicotine patches and behavioural support can assist smokers in remaining abstinent for     at least six months.   "
58363|NCT02521649|"     An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or     Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three     injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension     study period.   "
58364|NCT02521636|"     Investigators propose to conduct a prospective, randomized, controlled, multicenter assessing     the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on morbidity and     mortality in patients with chronic obstructive pulmonary disease (COPD) hospitalized in     intensive care unit (ICU) for acute exacerbation with or without associated pneumonia. The     main objective is to show in patients hospitalized in intensive care for acute exacerbation     of COPD with or without pneumonia, safety, defined as a lack of difference in mortality at 3     months, an antibiotic strategy guided by the PCT in the ICU.   "
58365|NCT02521623|"     An increasing number of women undergo an immediate breast reconstruction, where the     mastectomy and the breast reconstruction are performed in the same surgery. To aid survival     of the mastectomy skin flaps, and to provide better aesthetic results acellular dermal     matrixes (ADMs) are used to reinforce the breast. There are several different types of ADM     available for this purpose. In this randomized clinical trial, the following study will     investigate two different types of ADM (Strattice™ and SurgiMend®) in an immediate breast     reconstructive setting. Sixty patients will be allocated on a 1:1 ratio to receive either     Strattice™ or SurgiMend® ADM. Patients scheduled for immediate breast reconstruction with ADM     at pt. of Plastic and Reconstructive Surgery at Aarhus University Hospital, Aarhus, Denmark     will be offered participation. In total, 60 patients will be included. Outcome parameters of     interest are complication rate, patient satisfaction, aesthetic result and cost of the     procedure. Satisfaction and aesthetic result will be measured at 4 and 12 months post     surgery.   "
58366|NCT02521610|"     This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will     evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week     of RG7625 dosing in healthy male and female volunteers. Each participant will receive a     single dose of RG7625 or placebo followed by one week of dosing with the same treatment. Each     participant will also receive intradermal administration of 4 recall antigens at Screening     and on Day 7 of treatment to assess study drug effects on delayed-type hypersensitivity     (DTH).   "
58367|NCT02521597|"     To evaluate the residents' efficacy in diagnosing acute otitis media among febrile children     presenting with respiratory symptoms using a smartphone otoscope attachment compared with a     classic otoscope.   "
58368|NCT02521584|"     Study the effect of ischemia time on patient and graft survival.   "
58369|NCT02521571|"     The Resilience Alliance is a skill-based staff development intervention for child protective     staff that focuses on improving job satisfaction, resilience, optimism and social support,     while decreasing attrition, stress reactivity and burnout. The investigators believe that the     intervention will enhance the capacity of child welfare workers to care for themselves, which     will result in them providing better care for the children and families involved with the     child welfare system.      The Resiliance Alliance will be implemented in two child protective offices, Manhattan Zone C     and Brooklyn Zone B. Staff from two additional offices (Staten Island Zone A and Brooklyn     Zone C) will serve as a control group. A web-based survey will be administered in the group     receiving the Resiliance Alliance intervention prior to intervention, at completion of the     intervention, and 3 months post completion. The control group will be given a two-part     training (3 hours in total) on secondary traumatic stress. The control group will then be     asked to complete the same survey as the intervention group.   "
58370|NCT02521558|"     The current study will examine the use of a mobile electronic application used to deliver     cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to     Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific     cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them     to complete. The goal of this study is to determine if a) patients are able to use and adhere     to a cognitive rehabilitation program delivered to their mobile device and b) to determine if     patients can improve their language, attention, and memory by completing cognitive     rehabilitation tasks assigned to them.   "
58371|NCT02521545|"     The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061     in the new oral formulation in the fasted state in healthy male and female volunteers. The     secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in     the new formulation in this study population.   "
58372|NCT02521532|"     Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise     and decrease systemic blood pressure in multiple populations, including COPD. The chronic     effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.   "
58373|NCT02521519|"     This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep     intramuscular (PDI) injection for pain relief in chronic low back pain. Based on     randomization in first intervention session, one side receives MBB and the other side takes     PDI and in second session the pattern reverses.   "
58374|NCT02521506|"     Diabetes mellitus is one of the most prevalent disease in the western world. The control of     glucose levels has a big impact in the prevention of diabetes complications. The measure of     glucose levels in capillary blood with glucometers is the gold standard to measure and     control the glucose levels. Nowadays the glucometers become to more precise and sophisticated     devices. One of the most notables advance is the inclusion of software that cam predicts     glucose trends. This software has not be tested in routine clinical practice.   "
58376|NCT02521480|"     To determine whether real TMS is more effective than sham TMS in reducing pain following     surgery   "
58377|NCT02521467|"     Free gingival grafts are important to increase zone of attached gingiva and root coverage.     This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal     wound healing. The superior healing observed at the PRF membrane sites supports its use in     accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious     approach to protect the raw wound area of a palatal donor site to reduce healing time and     patient discomfort.   "
58378|NCT02521454|"     Successful policing requires rapid and unbiased decision-making, well-developed emotion     regulation skills, and psychological resilience. However, law enforcement officers (LEOs) are     frequently exposed to intensive work-related stress and trauma, and consequently, are at     elevated risk of adverse mental health outcomes. These mental health issues in turn are some     of the primary mechanisms underlying other- and self-directed violence among LEOs. The     excessive use of force by LEOs, including unjustified shootings, frequently captures national     headlines and is considered by many to be one of the most serious and divisive human rights     issues in the United States. Previous research suggests that LEOs can be impacted by various     factors when making rapid decisions while using firearms, including a lack of careful     consideration of contextual factors and unconscious racial stereotypes. This is especially     true when their cognitive and emotional resources are compromised due to factors such as     stress. Similarly, key precursors to suicide among LEOs include chronic stress, exposure to     trauma, alcohol misuse, and depression. The substantial personal, social, and economic costs     of LEO stress, including unjustified shootings and suicide, suggest a clear need for     innovative and novel prevention programs to promote well-being and reduce violence. Given its     demonstrated impact on many of the precursors to self- and other-directed violence among     LEOs, one possible approach is an adapted Mindfulness-Based Stress-Reduction (MBSR) program,     developed specifically for LEOs. Therefore, the primary objectives of this proposal are to:     (1) assess the feasibility of recruitment, adherence to program intervention, and compliance     with assessment instruments, and (2) determine the impact of an adapted MBSR program     (Mindfulness-Based Resilience Training; MBRT) on precursors to other- and self-directed     violence, and in promoting psychological resilience and emotion regulation among LEOs. There     is promising preliminary evidence suggesting that mindfulness is an effective strategy for     LEOs to decrease stress and its negative outcomes, enhance resilience and emotion regulation,     and ultimately reduce other- and self-directed violence. The proposed project will test the     impact of MBRT using a pilot feasibility randomized controlled trial (RCT). This research     will generate important information on the feasibility of recruitment, adherence to program     intervention, and compliance with assessment instruments, and data obtained through the     proposed study will build on the investigators existing work to provide support for a larger     RCT examining the efficacy of MBRT in reducing violence.   "
58379|NCT02521441|"     This was a randomized, open-label, active-controlled, dose-finding, phase II study to     evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with     breast cancer receiving myelotoxic chemotherapy.      Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose     of F-627 or Filgrastim, in an equal ratio.   "
58380|NCT02521428|"     The purpose of this retrospective observational study is to describe the sequence of     ICU-therapies that are limited and to compare characteristics and the decision making process     in surgical ICU-patients.   "
58382|NCT02521402|"     The main purpose of this study is to see if there is clinical benefit of using Biovance in     reduction of the recurrence of keloids when used to revise them. It will also assess the     postoperative complications.   "
58383|NCT02521389|"     This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3     sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A).     There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to     assess alternative dose levels or formulations, if required.      In each study part, each subject will receive a single dose of investigational medicinal     product PWT-143 in each of 2 study periods (total of 2 single doses).   "
70383|NCT02364700|"     This is an interventional pilot study investigating the feasibility of using the hand of hope     (HOH) device for individuals with decreased hand function after stroke.   "
58385|NCT02521363|"     The purpose of this study is to test the safety and feasibility of placing and removing a     small device that contains anti-cancer drugs in a breast tumor of patients who plan on having     breast surgery without treatment prior or patients who plan on receiving standard     preoperative chemotherapy prior to their breast surgery. This device may be able to predict     what types of treatment work best against an individual's breast cancer. With this device,     the investigators hope to be able to personalize treatment choices based on an individual's     type of breast cancer.   "
58386|NCT02521350|"     In the last few years, acute renal injury (AKI) definition has been significantly changed. In     the light of the data obtained from multicenter international studies, acute renal injury was     redefined according to RIFLE, AKIN and KDIGO criteria. The common criteria of all three     criteria in acute renal failure is the increment of level of creatinine as 0.3 mg/dL or 50 %     increment of respective basal value of serum creatinine.      In the current study, older than 40 years patients with no specific gender, who will stay at     least one night in hospital will be included and cardiovascular and urological surgery     patients and patients with known renal insufficiency will be excluded. It was aimed to     measure serum creatinine levels in all included patients at baseline and up to 24h after     surgery and will be determined acute kidney injury incidence and risk factors according to     new criteria.   "
58387|NCT02521337|"     Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation.     The incidence of preterm birth in Israel in the last years is around 7-8%.      Despite various diagnostic modalities as well as newly therapeutic approaches the incidence     of preterm birth remains unchanged and is considered to be the leading cause of neonatal     morbidity and mortality.      In the last decade, small RNAs have emerged as an important player in both physiological and     pathophysiological responses. These single strands, non-coding regulatory RNA molecules are     responsible for post transcriptional regulation of target genes. Hence, may provide a new     opportunity for biomarkers discovery in the field of preterm birth.      The main objective of this study is to identify a distinctive expression profile of maternal     circulating RNAs that will be used as biomarkers for preterm birth.   "
58388|NCT02521324|"     The current study is designed to evaluate the effect of device guided breathing (DGB) on     sleeplessness. Healthy subjects with mild to moderate sleeplessness that wish to improve     their sleep quality will be included in this study. The subjects will receive a belt type     breathing sensor, download the app on their smartphone, and will be required to perform DGB     at their home setting for 2 weeks after a baseline period.   "
58389|NCT02521311|"     The main purpose of this study is to assess clemastine as a remyelinating agent in patients     with acute optic neuritis.The study will also evaluate the tolerability of clemastine,     originally approved as first-generation antihistamine, in patients with optic neuritis. Study     procedures will include assessments for evidence of remyelination in the anterior visual     pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging.     If they are on one, patients in this study can remain on their standard disease modifying     treatment during the course of the study. However, patients cannot participate in any other     investigational new drug research study concurrently.   "
58390|NCT02521298|"     This study investigates the treatment effect on lateral elbow tendinopathy of strength     training in combination with cortico-steroid injection, dry-needling or placebo in a     double-blinded randomized controlled trial.   "
58391|NCT02521285|"     This randomized phase II trial studies the safety of and how well aspirin works in preventing     Barrett's esophagus from returning after it has been successfully eliminated by     radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus     for the levels of a specific protein that is linked to developing Barrett's esophagus may     help doctors learn whether aspirin can prevent it from returning after it has been     successfully treated.   "
58392|NCT02521272|"     The aim of the study is to investigate respiratory parameters of a person in the simulated     avalanche snow and consequent use of the measured data for development of a     mathematical-physical model of breathing during increasing hypercapnia in the avalanche.   "
58393|NCT02521259|"     This study evaluates the association between the depth of general anesthesia and the     occurrence of EA. The investigators hypothesized that optimal level of anesthetic depth could     decrease the incidence of EA in children undergoing strabismus surgery compared to the deep     level of anesthetic depth.   "
58394|NCT02521246|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drug associations in the essential hypertension control.   "
58395|NCT02521233|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drug associations in the essential hypertension control.   "
58405|NCT02521103|"     This study is a prospective, open-label, post-market, non-randomized, multi-center clinical     evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for     revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the     eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected     to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments     at 2 years postoperative.   "
58406|NCT02521090|"     This phase I/II trial studies the side effects and best dose of epidermal growth factor     receptor bispecific antibody (EGFRBi)-armed autologous T cells and how well it works in     treating patients with glioblastoma that have come back or does not respond to treatment.     EGFRBi-armed autologous T cells coated with antibodies (proteins used by the immune system to     target and kill foreign objects such as cancer cells) may have great ability to seek out,     attach to, and destroy glioblastoma cells.   "
58417|NCT02520947|"     213 patients undergoing elective on-pump coronary artery bypass grafting (CABG) were enrolled     into this prospective-clinical trial.After hundred and sixty three patients were excluded due     to various reasons, 50 patients were randomized to BIS (bispectral index) and MAC (minimum     alveolar concentration) groups. In BIS group (Group B, n=25), desflurane was titrated within     40 to 60 BIS values and in MAC group (Group M, n=25) within 0.7 to 1.3 MAC. Primary end point     of the study was to investigate the difference of desflurane consumption between groups.   "
58418|NCT02520934|"     evaluate the combination therapy with Miglustat and enzyme replacement therapy (ERT) on     Gaucher disease   "
58396|NCT02521220|"     Some studies have reported improved vascular function with the supplementation of L-arginine     in participants with cardiovascular disease (CVD). Several clinical studies have also begun     the investigation of L-arginine supplementation in participants with peripheral artery     disease (PAD). This is particularly important as currently there are limited options     available to medically manage intermittent leg pain resulted from PAD. Although some of these     short-term clinical trials suggested that oral L-arginine improved walking distance or     improved walking speed in participants with PAD, these results were not consistent. Further,     only 1% of the oral supplemented L-arginine is available for the NO production as the rest is     metabolised by the body. A better way to provide the body with substrate to produce NO is     therefore needed. The natural amino acid and food component, L-citrulline has been suggested     to be a good candidate for this purpose.      L-citrulline, named after watermelon citrullus vulgaris from which it was first isolated, is     a natural precursor of L-arginine. Studies have shown that L-citrulline is metabolised by the     body to a lesser degree compared to L-arginine and hence is an effective precursor of     arginine in peripheral tissues, including endothelial cells. Oral L-citrulline     supplementation also eliminates some of the unwanted effects associated with oral arginine     supplementation and it is well tolerated without known side effects. In addition,     L-citrulline is a supplement that is available over-the-counter. Thus, oral supplementation     of L-citrulline may be a new intervention strategy in participants with PAD.      The investigators hypothesize that the oral food supplement L-citrulline, unlike L-arginine,     reverses endothelial dysfunction. In a multinational, multicenter, double blinded,     randomised, placebo-controlled cross-over trial the effects of L-citrulline in peripheral     artery disease will be investigated.   "
58397|NCT02521207|"     The study will compare the study drug to an already marketed formulation of prescription     strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by     the body and also by performing a specialist procedure called an endoscopy (or more     specifically, a gastroscopy). The safety and tolerability of the study drug will also be     assessed.      The study will consist of 2 parts involving up to 54 healthy male and female subjects.     Subjects will be randomly assigned to receive either the study drug or reference product.     Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of     800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001     or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on     progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or     Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach     irritation using endoscopy.   "
58398|NCT02521194|"     The goal of this research study is to learn if inpatient occupational therapy can help     patients in the Palliative Care Unit (PCU).   "
58399|NCT02521181|"     The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight     (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure     in people with chronic kidney disease. However, the dose to prescribe in order to test this     possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help     determine the best dose of sodium bicarbonate to prescribe in a future study that will test     the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney     function in individuals with chronic kidney disease.   "
58400|NCT02521168|"     A condition of decreased serum T3 level in children after cardiac surgery using     cardiopulmonary bypass has been commonly recognized as euthyroid sick syndrome (ESS). This     syndrome has been closely associated with low cardiac output syndrome after heart surgery.     The unique characteristics of pediatric patients with congenital heart disease (CHD) in     Indonesia have caused ESS to arise in the population even before surgical managements.     Thyroid hormones increase cardiac function, respiration and diuresis. Increased myocardial     function occurred through the improvement of mitochondrial effectiveness as the body energy     source by utilizing effective energy substrates, lactate and pyruvate. Prevention of     decreased serum thyroid hormones level by T3 supplementation could be clinically beneficial.     Intravenous T3 unit dose is very expensive and inapplicable for daily use. In adult studies,     oral T3 was found to be effective for the prevention of decreased serum T3 levels; similar     study on pediatric population, however, has not been elucidated.   "
58401|NCT02521155|"     The purpose of the investigators' study is to assess effectiveness of community based oral     health literacy intervention promoting positive oral hygiene self-care behavior among     Montreal's Punjabi immigrants.   "
58402|NCT02521142|"     Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual     loss and classified blindness in the elderly throughout Europe and the US. Among these     patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible     for the most severe visual loss. There is now convincing evidence that vascular endothelial     growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels,     responsible for the development of the neovascular form of AMD. Today, the gold standard for     vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or     indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the     recent years tremendous enhancements in the field of optical coherence tomography have been     achieved. These developments made it possible to visualize the retinal vasculature in a full     depth manner without the application of an intravenous marker. The proposed study tests the     hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not     inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.   "
58403|NCT02521129|"     The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track     ablation device for liver biopsy.   "
58404|NCT02521116|"     To date two different instruments are commercially available to measure retinal oxygen     saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal     oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up     to now no data comparing both instruments for the measurement of retinal oxygen saturation     and vessel diameter are available in the literature.      Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy     subjects and patients with diabetic retinopathy or retinal vein occlusion between 2     commercially available systems (DVA, Oxymap T1)      Study design: Open pilot study      Study population:      30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate     non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein     occlusion, age 18-80 years      Topically administered medication:      Tropicamide (Mydriaticum Agepha®, Agepha, Vienna, Austria), dose: 1-2 drops per study day     for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein     (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements     of intraocular pressure Nonylacidvanillylamide combined with     Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH & Co KG, Vienna,     Austria): topical on the earlobe      Methods:      Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation     tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from     earlobe      Main outcome variables:      Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1      The motive for this investigation is to compare data between 2 commercially available     instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in     healthy subjects as well as in patients with ocular disease associated with altered retinal     oxygenation. Comparative data from both systems are currently not available. Data from this     study will allow the comparison of studies performed with different systems. All oxygen     measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears     to be acceptable.   "
58407|NCT02521077|"     This is a parallel-track, randomized study will observe whether intravenous ascorbic acid     reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for     early stage breast cancer.   "
58408|NCT02521064|"     Children with Crohn's disease can be effectively treated by remaining on a single-formula     diet for 8 continuous weeks. This dietary therapy is known as exclusive enteral nutrition     (EEN). It is just as effective as steroid treatment, which is what's traditionally used for     the initial treatment of Crohn's disease. It is not clear why EEN is an effective treated.     One possibility is that it changes the bacteria in our intestines, which allows the intestine     to heal. It is also unclear whether EEN can be used to treat ulcerative colitis, a disease     that is very similar to Crohn's disease. The purpose of our research project is to determine     whether EEN can be used to treat ulcerative colitis, and understand how the intestinal     bacteria changes while on EEN. Investigators will compare the results to patients who have     either Crohn's disease or ulcerative colitis, and are receiving standard treatment for their     disease (steroids). This is a pilot study, meaning that the goal of this study is to     determine whether a larger study is feasible. Investigators will measure patient recruitment     rates, whether patients are able to perform the treatment as requested, whether there are any     safety concerns, and whether investigators are able to collect the bloodwork and stool     samples without difficulty.   "
58409|NCT02521051|"     This research study is evaluating two drugs, alectinib and bevacizumab, as possible     treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).   "
58410|NCT02521038|"     Patients with acute coronary syndrome (ACS) require platelet inhibition after treatment.     P2Y12 receptor blockage is a well-known, proved method of urgent and effective blockade of     the platelet activation, and is applied to the current practice protocol. Ticagrelor is a     well-performing P2Y12 receptor blocking agent which is used in these patients. In the same     matter, it is essential to prescribe the exact dosage to optimize efficacy within the safety     limits. However current studies are based on Western countries, whereas there has been no     Ticagrelor patient registry in East-Asia. Thus it is reasonable to study the use of     Ticagrelor in a large registry of Korean ACS patients.      The BK registry is a Prospective, Open-label, Multi-center, Real world, Registry, with     prospective registration of patients receiving the medication, Ticagrelor. All subjects are     to be followed up for 18 months after diagnosis and treatment for ACS.      The purpose of this study is to observe and register clinical data including Major Adverse     Cardiovascular Endpoints and any total bleeding occurrence in Korean ACS patients treated     with Ticagrelor during 18 month follow-up. Also, the purpose includes to determine compliance     of Ticagrelor during post-approval commercial use and to determine prescription pattern of     Ticagrelor during post-approval commercial use.   "
58411|NCT02521025|"     In the present study, the investigators will assess the impact of two different feeding     patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following     bedrest.   "
58412|NCT02521012|"     Depression affects 350 million people worldwide. In the light of the global disease burden     statistics, the efficacy of current treatments for depression appears insufficient. Thus,     research on novel treatment interventions and predictors for good treatment response are     warranted. Earlier prospective follow-up studies and intervention studies suggest that     several bio-psychosocial factors, including high serum concentrations of vitamin D, are     related to better treatment outcomes. In this follow-up study with randomized clinical     vitamin D supplementation trial on patients with depression, the investigators aim to        1. clarify how a six-month intervention with vitamin D supplementation affects treatment          response, recovery, and the biological pathways related to depression. This aims to          finding potential sub-groups getting benefits from vitamin D supplementation. In          addition, the investigators want to        2. investigate and characterize factors related to recovery from depression and working          ability in depression patients in the long-term. The investigators are especially          interested in the bio-psychosocial factors and the aims include examining both the          individual's positive resources.      The trial will start with a six-month double-blinded randomized controlled trial with vitamin     D supplementation. The aim is to recruit altogether 3028 patients with non-psychotic,     unipolar depression, aged 18-65 years, who are referred to the recruitment sites for     treatment for depression. The participants will be randomized to low (10 µg/day) or high (100     µg/day) vitamin D supplementation group. Clinically necessary antidepressant treatments will     continue during the intervention as needed. After six months of intervention, the     participants will be followed up at 18 months and at 5 years.      Several measurements will be conducted during the intervention and follow-up period.     Participants will fill a variety of clinical questionnaires and questionnaires with     background information. All participants give blood samples for biomarker analyses at time     points 3, 6, 18 months and 5 years. Clinical interviews of mental disorders (e.g. SCID) and     anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.   "
58413|NCT02520999|"     Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid     infusion, external pressure can be used. The investigators will study correlation between     external pressure and hemolysis and deformability of red blood cell.   "
58414|NCT02520986|"     In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two     surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation,     will be compared. The primary outcome of the study is the cosmetic result judged by the     Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS), secondary     outcomes are intervention time, operative complications, subjects and users satisfaction,     postoperative pain and recurrence of genital warts.   "
58415|NCT02520973|"     Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal     and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant     women have active TB , many with advanced disease, contributing to the 40% of maternal     mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in     this setting is therefore essential to reduce maternal mortality. Symptom-directed screening     for TB has been recommended by the World Health Organization and by the South African     National Department of Health; however, no implementation framework is in place to     operationalize the guidelines. Symptom-based testing is an efficient process that limits use     of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of     HIV-infected women had active TB when a symptom-based strategy was employed once, but in     Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing,     regardless of symptoms, was performed; most TB cases were newly diagnosed among women who     reported no symptoms .   "
58416|NCT02520960|"     Prospective observational multicentric study evaluating the efficacy of considering unipolar     signal modification during radio frequency catheter ablation of patients with symptomatic     paroxysmal atrial fibrillation in France between November 2013 and January 2015. All     procedures were conducted according to the standard clinical care and current guidelines.     Pulmonary vein isolation was guided according to force (at least 10 grams) and application     vector (perpendicular to the wall) developed until the atrial unipolar electrogram recording     became a complete positive signal. Patients were discharged from hospital free of any     anti-arrhythmic drugs. Recurrence of arrhythmias at 12 months (primary outcome) was assessed     by continuous 48-hour Holter at 1, 3, 6, 9 and 12 months post-catheter ablation.   "
58419|NCT02520921|"     To compare treatment with enteric coated aspirin twice a day (100 mg in the morning and 100     mg in the evening) versus enteric coated aspirin 100 mg once per day on a composite end-point     of ischemic events in diabetic patients with acute coronary syndrome.      It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic     event after acute coronary syndrome in diabetic patients.   "
58420|NCT02520908|"     Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant,     Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically     runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very     bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete     remissions exceptionally occur and quality of life is severely affected. Several publications     have reported durable responses following allogeneic hematopoietic stem cell transplantation     (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in     treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study     will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic     HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive     standard of care in patients with advanced-stage ETCL with poor prognostic features, will be     performed. Patients are included at the time of donor search irrespective of the results, and     compared on a donor versus no donor basis. It is an observational study since no intervention     is made except the comparison of outcomes of groups that receive usual care (HSCT if donor     available, or not).   "
58421|NCT02520895|"     RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire     diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and     chronic lymphocytic leukemia before and after treatment, and to evaluate the association of     these parameters with clinical patient data and outcomes.   "
58422|NCT02520882|"     This is an open-label positron emission tomography/computed tomography (PET/CT) study to     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in     glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will     be injected intravenously. Visual and semiquantitative method will be used to assess the     PET/CT images.   "
58423|NCT02520869|"     All patients will go through an ICSI (intracytoplasmic sperm injection)cycle Monitoring: COH     (controlled ovarian hyperstimulation) will be monitored by transvaginal sonography, and then     the dose of gonadotropin will be adjusted according to the follicle size and number.      Triggering ovulation: when three or more follicles reach >18mm, endometrium triple line >8mm,     both the gonadotropin and agonist injections will be stopped and 10,000 IU of hCG(human     chorionic gonadotropin ) will be given.      Egg collection : 34-36 hour after hCG injection, embryo transfer :48-72 hour after oocyte     retrieval. Luteal phase support: with 100 mg progesterone injection IM daily until the day of     the pregnancy test pregnancy test: 15 days after the embryo transfer. Semen collection and     preparation Semen samples will be collected by masturbation in clean containers, usually     after 2-3 days of abstinence. Each sample will be allowed to liquefy for at least 20 min at     37 °C.      Semen analysis:      Basic sperm parameters including sperm count, concentration, motility and morphology will be     evaluated according to World Health Organization guidelines. After the initial assessment,     ejaculates will be divided into three aliquots. An aliquot of each sample will be used to     assess sperm DNA damage, the second aliquot will be processed by direct swim-up technique (n     30) or zeta test technique (n 30) this will be followed by assessment of DNA damage again in     each sample to measure the difference in DNA damage after processing in each technique then     spermatozoa from the third aliquot will be morphologically analyzed manually using Spermic     stain and a light microscope and will be scored according to WHO   "
58424|NCT02520856|"     Hypertrophic cardiomyopathy (HCM) is an autosomal dominant disease characterized by     unexplained hypertrophy of the left ventricle, often with predominant involvement of the     interventricular septum, and characterized by myocyte disarray and fibrosis.      HCM is the most common familial heart disease with strong genetic heterogeneity, demonstrated     over the past 20 years. Mutations in 11 or more genes encoding proteins of the cardiac     sarcomere are responsible for (or associated with) HCM.      However, 30-40% of sporadic and familial cases of HCM are still genetically unlabelled. In     addition, secondary HCM caused by Fabry's disease or amyloidosis, may mimic primary HCM and     may be under diagnosed. This may result in a delay in accurate diagnosis and instauration of     specific treatment, with possible clinical consequences for the patients.      For these reasons, we decided to apply a new diagnostic strategy for patients with newly     diagnosed HCM, including the whole exome sequencing (WES) technology.      If correctly applied, this new technology has the potential to strongly reduce the diagnostic     wavering leading to earlier diagnosis and genetic counseling in sarcomeric HCM and rarer     forms of secondary HCM including Fabry's disease and amyloidosis, and also specific therapy     set-up in secondary forms of HCM. It should also allow identifying new genes responsible for     HCM.   "
58425|NCT02520843|"     Crohn's disease is a chronic inflammation of all or part of the digestive tract,  from the     mouth to the anus . .      Cell therapy is a new and promising approach for the treatment of inflammatory disease     including Crohn's disease and fistulas.      Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open,     non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and     will be conducted over a period of 28 month.      This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano     refractory to conventional medical and surgical treatment, the safety and efficacy of local     microinjection of autologous adipose tissue and SVF from microaspirate .      The main objective is to assess tolerance and security. The secondary objective is to     evaluate the effectiveness of this technique   "
58426|NCT02520830|"     Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in     epidemiological studies.      Dietary intervention studies with certain micronutrients have shown promising effects on     surrogate parameters of vascular risk including blood pressure, endothelial function and     cholesterol levels. Wild blueberries have gained attention due to their high content of     phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular     function and health when given over relevant time periods and in relevant populations is not     known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption     of wild blueberries can improve endothelial function, a prognostically validated surrogate of     cardiovascular risk.   "
58427|NCT02520817|"     Minimal hepatic encephalopathy (MHE) can have a far-reaching impact on quality and ability to     function in daily life and may progress to overt Hepatic Encephalopathy. Patients with MHE     were missed in clinical follow up and are more exposure to work accident. The aim of the     present study was to assess the effects of oral supplementation of antioxidant and zinc     gluconate Versus Lactulose inTruck driver cirrhotic patients with MHE.   "
58428|NCT02520804|"     The purpose of this study is to determine Acute kidney injury incidence between sterofundin     and normal saline ; Resuscitation shock patients   "
58429|NCT02520791|"     This phase I trial studies the side effects and best dose of anti-inducible T-cell     co-stimulator (ICOS) monoclonal antibody MEDI-570 in treating patients with peripheral T-cell     lymphoma follicular variant or angioimmunblastic T-cell lymphoma that has returned after a     period of improvement (relapsed) or has not responded to previous treatment (refractory).     Monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may block cancer     growth in different ways by targeting certain cells.   "
58430|NCT02520778|"     This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when     given together and to see how well they work in treating patients with previously treated     epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread     to other places in the body or has not responded to previous treatment with initial EGFR     kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving with osimertinib together with navitoclax     may work better in treating EGFR-positive non-small cell lung cancer.   "
58431|NCT02520765|"     This study is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist     Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI.   "
58432|NCT02520752|"     Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of     midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors   "
58433|NCT02520739|"     The Mediterranean diet, in which olive oil is the main source of fat, has shown to be     protective for chronic degenerative diseases. These diseases, such as cardiovascular, cancer,     and neurodegenerative, and even the aging process, are linked to oxidative stress and     inflammation. Recently, the Prevention through Mediterranean Diet Study has provided for     first time evidence of the benefits of the Mediterranean diet on the primary prevention of     cardiovascular disease.      Olive oil, besides its high content of a healthy fat, the monounsaturated (MUFA) one: the     oleic acid, has minor components with bioactive properties. The minor components of virgin     olive oil are classified into two types: the unsaponifiable fraction, defined as the fraction     extracted with solvents after the saponification of the oil, and the soluble fraction which     includes the phenolic compounds. The content of the phenolic compounds (polyphenols) of an     olive oil depends of the variety of the olive fruit, the cultivar, the climate, the ripeness     of the olive, and the type of processing. Virgin olive oils obtained from the first press of     centrifugation of the olives are those with high phenolic content. On November 2011, the     European Food Safety Authority released a claim concerning the benefits of the daily     ingestion of olive oil rich in phenolic compounds, such as the virgin olive oil. Due to this,     the need to optimize the olive oil processing in order to obtain high phenolic content olive     oils is one of the current goals in terms of increasing the nutritional value of an olive     oil. To obtain an optimized olive oil with high phenolic content (OHPCO) has been one of the     achievements within the frame of the NUTRAOLEOUM Project.      However, the healthy properties of the new olive oils (OHPCO and FOO), according to the     Evidence Based Medicine must be tested in proper clinical randomized trials. New olive oil     products need to be tested in front of the parental ones (i.e. virgin olive oil obtained by     common procedures) in order to ensure that their healthy properties are highlighted. This is     the purpose of the NUTRAOLEUM Study. In order to be able to obtain future health claims from     EFSA or FDA, for the products, the investigators will also examine the bioavailability in     humans of the active principles (phenolic compounds and triterpenes) of the olive oils, as     well as possible basic mechanisms involved in the potential health benefits of the olive oils     tested.   "
58434|NCT02520726|"     This is a randomized, double-blind, placebo-controlled study to determine whether     administration of sertraline to patients who exhibit acute stress disorder secondary to     severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).   "
58435|NCT02520713|"     This research study is evaluating the use of specialized testing of solid tumors including     sequencing. The process of performing these specialized tests is called tumor profiling. The     tumor profiling may result in identifying changes in genes of the tumor that indicate that a     particular therapy may have activity. This is called an individualized cancer therapy (iCat)     recommendation. The results of the tumor profiling and, if applicable, the iCat     recommendation will be returned.   "
58436|NCT02520700|"     Photodynamic therapy (PDT) uses visible light to treat a premalignant condition, called     actinic keratosis, which results on chronically sun exposed skin such as on a balding scalp.     A cream is applied containing aminolaevulinic acid or methyl aminolaevulinate and this is     converted in the cells to the photodegradable product protoporphyrin IX (PpIX). Visible light     causes the degradation of PpIX resulting in the production of reactive oxygen species and     then cell death in the actinic keratosis. In conventional PDT a lamp is used to supply the     visible light. The main draw back to treatment is pain. Recent studies have shown that     daylight can be used as the source of visible light and is as effective as conventional PDT.     Patients find this form of treatment less painful and therefore preferable. The reduction in     pain seen in daylight PDT appears to be related to the fact that no significant quantity of     PpIX accumulates prior to exposure to the light source and small quantities of PpIX are     activated continuously during daylight exposure. The drawback of performing daylight PDT in     Ireland is the climate, both in terms of cloud cover and temperature. The typical daylight     treatment times is 2 hours and it would be difficult for patients to stay outside in winter,     spring and autumn. This study investigates the use of an artificial white light source, a     Maquet PWD 50SF theatre-light, as an alternative.   "
58459|NCT02520401|"     This studies aims to investigate the effect of a probiotics in peri-implantitis patients as     an adjunct to non-surgical therapy.   "
58460|NCT02520388|"     This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in     patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout     period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of     3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.   "
58437|NCT02520687|"     High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with     serious adverse outcomes for both mother and baby. Treatment options for the management of     high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals     have shown that supplementation with dietary nitrate, using beetroot juice, can significantly     lower blood pressure and improve blood flow. This study aims to investigate whether     supplementation with dietary nitrate (via beetroot juice) can improve blood pressure     regulation in pregnant women with chronic high blood pressure, and will also determine     whether this can improve blood flow across the placenta.   "
58439|NCT02520661|"     The emergency department (ED) is a common source of acute illness care for older adults. Many     older adults who are discharged home from the ED return within 30 days due to numerous     challenges faced during the ED-to-home transition. Unless programs to improve the ED-to-home     transition are identified, the health and financial costs will only increase as the older     adult population doubles by 2040. This study will apply Coleman's Care Transitions     Intervention to the ED-to-home transition by adapting the program to account for the unique     aspects of the ED setting. The research will evaluate the process, ED use, and cost outcomes     of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion,     this study will provide empiric evidence regarding this innovative approach to help the     rapidly growing older adult population remain healthy and independent after an ED visit.   "
58440|NCT02520648|"     The purpose of this trial is to investigate the immediate effects of neuro-lymphatic     treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical     and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.   "
58441|NCT02520635|"     The primary purpose of the study is to evaluate the efficacy and safety of supra-early     post-surgery chemotherapy versus standard TEMODAL® regimen in treatment of patients with     newly diagnosed glioblastoma multiforme. The secondary purpose is to assess the efficacy of     supra-early post-surgery chemotherapy in release brain edema.   "
58442|NCT02520622|"     The primary aim is to determine the impact of using digital photographs on a mobile device     versus printed photographs on skin self-examination rates. The ease-of-use and overall     satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on     melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be     evaluated. The study involves patients in the Pigmented Lesion Clinic that have received     total body photography for skin monitoring.   "
58443|NCT02520609|"     Background:      Metabolism refers to the many chemical pathways by which various compounds, including food,     are processed and used in the body. People with non-alcoholic fatty liver disease (NAFLD)     have too much fat in their liver cells, but what causes it is unclear. One explanation is     that people with NAFLD process food and metabolize it differently than people without NAFLD.     Researchers want to compare how food is metabolized in people with and without NAFLD.      Objective:      To better understand how food intake influences the development and progression of NAFLD.      Eligibility:      People ages 18 and older with NAFLD or with a non-NAFLD metabolic syndrome      Healthy volunteers ages 18 and older      Design:      Participants will be screened with medical history, surveys, physical exam, and blood tests.     This will have ultrasound of the abdomen. This uses sound waves to image internal organs.      Participants will stay at the Clinical Center for 2 nights.      They will fast he first night.      On the second day they will:      Have their metabolism monitored in a metabolism research room for 24 hours      Have a catheter inserted into an arm vein for several blood tests      Drink an Ensure Plus for breakfast      Have solid meals for lunch and dinner      Have several urine tests.      The final morning, they will:      Have more blood tests.      Have a DXA test to measure the fat in the body. They will lie on their backs for 15-25     minutes while an x-ray machine is positioned over areas of the body.   "
58444|NCT02520596|"     Red raspberries are a rich source of (poly)phenolic compounds, the main components being     anthocyanins and ellagitannins. There is growing evidence linking consumption of these     compounds with beneficial effects on human health. However, the mechanisms involved remain     poorly understood principally because of a limited understanding of the bioavailability of     ellagitannins and anthocyanins. This study aims to explore the identity and amounts of the     phenolic metabolites of anthocyanins and ellagitannins in human plasma and urine following     acute ingestion of raspberries. For this purpose ten healthy volunteers were feed 300 g of     blended raspberries containing in total 293 μmol anthocyanins and 250 μmol ellagitannins. All     urine excreted over 48 h after the ingestion of raspberries was collected and blood samples     were collected before (0 h) and after raspberry consumption up to 24 h. Metabolites were     identified and quantified by ultra high performance liquid chromatography-mass spectrometry     (UHPLC-MS).   "
58445|NCT02520583|"     To determine the effect of probiotic supplementation on the inflammatory response and     subsequent performance following a muscle damaging exercise bout, a double-blind, randomized     placebo controlled two-factor repeated measures design will be employed. The dependent     variables for this study will include measures of performance as well as markers of     inflammation in a single limb model. Participants who qualify for study participation will     have their height, weight, and body composition assessed (skin fold) followed by baseline     measurements for determination of isometric and dynamic strength. Initial limb will be     determined randomly. Following baseline testing, participants will randomly be assigned to     ingest either a probiotic or placebo. Supplementation will begin at least 24 hours post     baseline testing. Twenty-one days after initiating supplementation, participants will again     complete performance testing followed by an exercise bout known to elicit muscle damage and     produce an inflammatory response. Participants will then repeat performance testing 24, 48,     and 72 hours post muscle damaging bout. Blood samples for determination of markers of     inflammation will be taken throughout study duration. Following a 3-week wash-out period (21     days), participants will repeat the experiment following the alternate supplement regimen     with the contralateral limb.   "
58461|NCT02520375|"     The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in     periodontitis patients as an adjunct to scaling and rootplaning.   "
58446|NCT02520570|"     1. Investigate the application of ulinastatin in real practice clinic.(eg:population          character, usage and dosage, course of treatment,etc )        2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect          the main clinical manifestations, treatment, outcome, influence factors; provide          evidence for improving the recommended medication plan of ulinastatin.        3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence          for appropriate medication to administration department of health authority.   "
58525|NCT02519530|"     Investigators are carrying out a study to assess the immediate and long-term effects of a     positive youth development program (the Teen Outreach Program) on high school youth in     Florida. This study will answer the following questions: What is the impact of the Teen     Outreach Program on sexual activity and positive youth development at the end of the program     and 10 months after the program?   "
58447|NCT02520557|"     The purpose of this study is to understand if people with certain genes are predisposed to     develop severe skin reactions after they are administered Eslicarbazepine Acetate. Currently     there is no information that suggests that certain individuals who use Eslicarbazepine     Acetate are predisposed to develop severe skin reactions. However, previous research has     shown that seizure medicines like carbamazepine (Tegretol®) and oxcarbazepine (Trileptal®,     Oxtellar XR®) are more likely to cause severe drug related skin reactions in some people of     Asian ancestry who have specific genes. These are genes found in an area of chromosomes     called the Major Histocompatibility Complex. This association is called a genetic risk     factor. The study objective is to compare information that is obtained from individuals with     a history of seizure disorders who develop severe skin reactions while using Eslicarbazepine     Acetate to a group of patients who also have a history of seizure disorders and do not have a     history of a severe skin reaction after using Eslicarbazepine Acetate.   "
58448|NCT02520544|"     The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium     cup survivorship over years.   "
58449|NCT02520531|"     Single-centre, prospective, randomized comparative study to compare the maximum flexion and     Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of     all complications.   "
58450|NCT02520518|"     Th mechanism of action of dapagliflozin is via sodium-glucose co-transporter 2 (SGLT2)     inhibition. Sodium-glucose co-transporter 2 inhibition is associated with moderate weight     (fat) loss, in addition to other health benefits, including decreased blood pressure,     decreased inflammation, and decreased oxidative stress. It is unclear as to whether these     health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss.   "
58451|NCT02520505|"     This is a prospective randomized control, crossover trial to determine if supraovulation with     clomiphene citrate and intrauterine insemination is more efficacious than expectant     management in women with stage III or IV endometriosis who have recently undergone operative     laparoscopy.   "
58452|NCT02520492|"     In patients at risk of increased intracranial pressure (ICP), ICP measurements require     invasive transducers, usually with insertion of a catheter into the cranium, or through a     spinal tap. These invasive modalities involve risks and pain and they can be done only in     specialized care units, with a high associated cost.      A novel method for detecting changes in ICP has developed recently. The auditory hair cells     emit sounds and electric signals in response to sound, which can be easily detected and     measured non-invasively with the help of a microphone probe placed in the external ear canal     or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)     spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within     seconds.      A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination     of causes: the inflammatory reaction around the tumor, the mass effect of the tumor,     secondary vascular changes, a change in the flow of CSF.      The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the     monitoring of intracranial tumors. It is then detected by using routine clinical signs, in     combination with a standard imaging method (MRI), but still subjective.      The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate     whether the increase in ICP precedes tumor clinical worsening and / or imaging.   "
58453|NCT02520479|"     A phase 2 study was conducted of sandwich protocols, with earlier RT after an initial 2 of     P-CHOP (Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone ), followed     by further two consolidation cycles,to explore the appropriate mode of combined modality     therapy (CMT) in early stage ENKTL.   "
58454|NCT02520466|"     The aim of the present study is to investigate whether the ingestion of a cocoa     flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and     platelet function in patients with overt coronary artery disease acutely (after 2 hours)   "
58455|NCT02520453|"     Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer     following neoadjuvant CCRT.   "
58456|NCT02520440|"     The gastrointestinal dysfunction occurs frequently during the intensive care unit (ICU) stay     and is associated with a worse prognosis.      The gastrointestinal failure (GIF) is diagnosed based on symptoms such as bowel distension,     ileus, diarrhea, digestive bleeding, or intestinal ischemia. A GIF score based on has been     demonstrated to be correlated with outcome, with higher scores indicating higher risk of     death. However, GIF may be occult or clinical signs can go undetected in critically ill     patients due to the frequent use of analgesic, sedative or neuromuscular blocking agents,     acute neurologic diseases, or delirium.      Citrulline is a potential biomarker for small bowel function in critically ill patients with     maintained renal function. Normal plasma citrulline levels (12-55 µmol/L) are determined by     the balance between gut synthesis and kidney degradation.      GIF is involved in the pathogenesis of multiple organ dysfunctions and failures (MOF) through     various mechanisms, and it is often associated with high intra-abdominal pressure (IAP). IAP     greater than 12 mmHg, may lead to abdominal compartment syndrome (ACS) and MOF, including     cardiac, respiratory and kidney failure. Studies have suggested that GIF can be the     consequence rather than the cause of MOF.      The aim of this study is to investigate if plasma citrulline levels is associated with a     clinical diagnosis of GIF, and may predict the development of MOF.   "
58457|NCT02520427|"     The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a     continuous IV infusion is safe and tolerable in adult subjects that have relapsed/refractory     Acute Myeloid Leukemia, and to determine the maximum tolerated dose and/or a biologically     active dose. The study will be conducted in multiple sites and test increasing doses of AMG     330. The safety of subjects will be monitored by intensive assessment of vital signs,     electrocardiograms, physical examinations, and laboratory tests.   "
58458|NCT02520414|"     The purpose of this study is to determine the safety and feasibility of using the Symphion     system in an office setting.   "
58524|NCT02519543|"     In a previous study by Dr. Calkin, the principal investigator of this study, persons with     bipolar disorder and either type II diabetes or insulin resistance were found to experience     more severe symptoms of bipolar illness and a lower response to treatment, compared to     persons with bipolar disorder who did not have type II diabetes or insulin resistance. To     further explore these findings, the investigators have developed this study to see if adding     metformin, a drug used to improve the body's use of insulin, may also help improve the     symptoms of bipolar illness.   "
58462|NCT02520362|"     This is a prospective open cohort study with annual assessment and reporting of descriptive     findings and a final report at the end of the study to address all study objectives. The     study period will include 10 years of data accumulated in each data system. The study start     date is the denosumab international birth date, 26 May 2010. The data end date will be 10     years after the international birth date, 25 May 2020.The primary data sources will be the     following:• US Medicare, including Parts A, B, and D• United HealthCare• Scandinavian     national health registry databases, including data from Denmark, Sweden, and Norway. Data     will be collected for postmenopausal women overall, women with Postmenopausal Osteoporosis,     and patients who receive Prolia for unapproved indications. Among women with Postmenopausal     Osteoporosis, exposure cohorts will be established based on exposure to denosumab or     bisphosphonates. Nine adverse events of special interest will be identified using validated     algorithms based on inpatient and outpatient diagnosis and procedure codes, and, for some     AESI, medication codes or laboratory data. Selected AESI (osteonecoris of the jaw and     atypical femoral fracture) will be confirmed by medical chart review.   "
58463|NCT02520349|"     The proposed research is a longitudinal human lab study to examine how measures of abuse     liability and product appeal vary by e-cigarette device type, and how these lab assessments     may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An     additional aim is to evaluate e-cigarette safety and tolerability among smokers by device     type.   "
58464|NCT02520336|"     Assess postpartum diabetes screening in GDM patients with initiation of a reminder system in     the postpartum period   "
58465|NCT02520323|"     The objective of this study is to determine the presence of bacterial species, and the     immunologic and molecular mechanisms of granuloma formation that might be involved in the     pathogenesis of sarcoidosis. The investigators will collect peripheral blood and     bronchoalveolar lavage fluid samples to isolate bacterial DNA and blood monocytes and     lymphocytes. Specimens will be obtained from patients with sarcoidosis, with non-sarcoid lung     disease, and healthy volunteers to directly compare the bacterial species present and the     characteristics of cells thought to be involved in granuloma formation.   "
58466|NCT02520310|"     The objective of the study is to confirm the reproducibility of the evidence of safety and     efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for     mitral valve surgery by the local site heart team.   "
58467|NCT02520297|"     The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe     acute pain in patients presenting to the emergency department (ED) with a suspected/known,     unilateral, closed long bone fracture.   "
58468|NCT02520284|"     This study will evaluate the efficacy, safety, and tolerability of GS-5745. It will consist     of 3 parts: Induction Study (Cohort 1), and Maintenance Study (Cohort 2), and an Extended     Treatment Phase.   "
58469|NCT02520271|"     Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district     of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up     study on depression and related substance use disorders (SUD). The study focuses on several     aspects concerning the relation of depression and SUDs, the efficacy of selected assessment     and treatment protocols, characteristics and genetics of the participants and the use of     related biomarkers in clinical practice. The misused substance in focus is alcohol. In this     study, dual diagnosis (DD) is defined as the simultaneous presence of clinically diagnosed     major depressive disorder (MDD) and alcohol use disorder (AUD). The study was approved by the     local ethics committee. Written informed consent was collected from all participants.   "
58470|NCT02520258|"     Experiments have shown that some artificial sweeteners like those in diet soda can cause     changes in how the body responds to and uses sugar. These changes increase the chance of     obesity, type 2 diabetes, and other metabolic diseases. In this study, the investigators plan     to see if the most common artificial sweetener, aspartame (brand name Equal, NutraSweet),     causes these changes. The investigators believe that if metabolic changes are observed in a     person who consumes aspartame, then removing all aspartame from the diet might lead to a     reversal of the changes and a normalization of test results.This would impact sweetener     additives in our foods and thus decrease the incidence of obesity, diabetes, and the     metabolic syndrome.   "
58471|NCT02520245|"     This study has been designed to collect long-term follow-up information for patients who     received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.   "
58472|NCT02520232|"     Alzheimer's disease (AD) is an irreversible, progressive brain disease. It is the most common     form of dementia and the major cause of functional dependence in the elderly. Since there is     currently no cure for Alzheimer's disease, a growing number of scientists pointed out the     interest to use non-pharmacological alternative therapeutic approaches in order to slow down     the decline of physical and cognitive resources and improve quality of life of patients with     Alzheimer's disease. Several narrative and meta-analytical reviews suggest that regular     practice of physical activity delays the occurrence of cognitive decline and slows down     Alzheimer's disease progress when compared with sedentary people. Despite the growing     interest of the scientific community for the positive effects of chronic exercise on mental     health and cognitive functions, the clinical reality of this phenomenon remains to be clearly     established, more particularly in aged people suffering from neurodegenerative diseases.The     first aim of this research project is to test if chronic exercise reduces and even     compensates for a cognitive decline in both patients with prodromal Alzheimer's disease     (i.e., no dementia) and aging people with no pathology of central nervous system. The second     aim of this research project is to examine whether an increasing of cerebral blood flow     induced by chronic exercise can explain this positive effect.   "
58473|NCT02520219|"     The aim of this study is to evaluate anti-tumor safety and efficacy of endostar®（Human     recombinant endostatin injection）combined with traditional GDP     （gemcitabine+dexamethasone+cis-platinum）chemotherapy for newly diagnosed or relapsed     PTCL(aggressive peripheral T-cell lymphomas) patients in phase II clinical study.   "
58536|NCT02519387|"     This is a phase IV, open-label and single-arm study of patients with non-malignant pain due     to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not     responding to non-opioid analgesics. The primary objective was to assess the efficacy of     buprenorphine transdermal patch for pain control among these patients.   "
58537|NCT02519374|"     Assessment of the digestive tolerability of the PROMITOR® .   "
58474|NCT02520206|"     The investigators propose to conduct a translational study on the regulation of     S-adenosylmethionine synthesis and cellular methylation reactions during chronic     inflammation. Development of in vitro cell models may reveal the regulatory mechanisms by     which specific inflammatory mediators cause metabolic changes and alter DNA methylation     status. Metabolic and pharmacological studies in the in vivo models will enable us to better     understand the regulation of inter-organ homeostasis of S-adenosyl methionine and help     identify tissue specific biomarkers for methylation and epigenetic modifications in different     stage of chronic inflammation. The clinical study in human subjects will help distinguish the     impacts of autoimmune rheumatic disease, degenerated joint disease, or specific medication     use on significant clinical and biochemical markers in folate and vitamin B6 metabolic     pathways.The Investigators hope the present study can identify specific clinical markers for     potential epigenetic changes in patients suffering from chronic inflammation, which will     contribute to better clinical management of these diseases in humans.   "
58475|NCT02520193|"     The purpose of the present study is to compare usual care in terms of mobilization performed     to intubated ICU patients to a standardized program designed to deliver early mobilization at     least 5 days a week.      This study has a before / after design with a control group during the experimental phase.     The first phase of the study corresponds to an observational phase during which every act of     mobilization performed to the included patients is going to be documented. During this first     study period, total duration of mechanical ventilation is going to be recorded for all the     patients included.      At the end of this first study period, the participating ICU are going to be randomized     (Cluster randomization) in two groups either observational or experimental. The corresponding     strategy is going to be applied to all the patients included during the second study period.     During this second period, total duration of mechanical ventilation is also going to be     recorded for all the patients included.      The study hypothesis is that applying a protocolized early mobilization strategy increases     the number of ventilator free-days during the 28 days after intubation in ICU patients.   "
58476|NCT02520180|"     Purpose The TARGET All comers trial is a prospective, multicenter, randomized, two-arm,     non-inferiority, open-label study with 1656 patients at 20 centers in Europe. The study is a     real world, all comers study.   "
58477|NCT02520167|"     This study will pilot and assess feasibility of a prenatal intervention for obese pregnant     women based on the Diabetes Prevention Program (DPP). Intervention group participants will     meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a     DPP-based curriculum and receive breastfeeding education. Control group participants will     receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational     weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks     postpartum.   "
58478|NCT02520154|"     The goal of this clinical research study is to learn about the safety of giving the     combination of pembrolizumab, carboplatin, and paclitaxel to patients with high-grade     epithelial non-mucinous ovarian, primary peritoneal, or Fallopian tube cancer. Researchers     want to find out how the disease responds to therapy with pembrolizumab.   "
58479|NCT02520141|"     The goal of this clinical research study is to learn if ramucirumab can help to control     biliary cancer. The safety of this drug will also be studied.   "
58480|NCT02520128|"     IMRiS is a phase II trial which aims to assess the feasibility, efficacy and toxicity of     Intensity Modulated Radiotherapy (IMRT) in three different cohorts of patients with primary     bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical     outcomes.   "
58481|NCT02520115|"     This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum     samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian     cancer. Studying samples of serum from patients with ovarian cancer in the laboratory may     help understand the use of folate receptor induction as a clinical tool in initial diagnosis,     surveillance, and recurrence.   "
58482|NCT02520102|"     Primary Objective:      Measure the proportion of patients who develop binding and neutralizing antibodies in the     blood after treatment with sargramostim following induction/reinduction chemotherapy.      Secondary Objectives:        -  Assess the time after treatment at which the antibodies develop and the level of          antibodies is measured after the first dose.        -  Measure the levels of immunoglobulin protein.        -  Assess the impact of any immune response on safety and the duration of low white blood          cell count.   "
58483|NCT02520089|"     Patients with humeral shaft pseudoarthrosis is going to be treated with a standard protocol     with a locking compression plate and bone autograft, and other group of patients treated with     platelet rich plasma.      Posteriorly all the patients it will evaluated radiographically and with functional scales     for a period of one year.   "
58484|NCT02520076|"     Islet transplantation is a relatively new procedure used in people with difficult to control     Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas donated by the     next of kin of a person who is brain dead. After the cells are prepared, the islets are     transplanted into the recipient's liver and produce insulin. Patients who receive an islet     transplant take medication that suppresses their immune system and prevent rejection of the     islet tissue.      The investigators have also learned that there is general inflammation at the time of the     transplant that is not fully controlled with our standard medications. The investigators     believe this inflammation may cause some islet cell death around the time of transplant. Due     to this islet death around the time of transplant, most recipients need 2 or 3 separate     transplant procedures.      The investigators are studying the use of Alpha-1 Antitrypsin (AAT) in islet transplant to     decrease the amount of cell death caused by general inflammation. In this study, the     investigators hope to decrease the need for more than one transplant procedure by controlling     inflammation, before and after transplant, with Alpha-1 Antitrypsin (Aralast NP).      Alpha-1 Antitrypsin is a protein made in healthy humans that helps to prevent tissue damage     during times of inflammation. Alpha-1 Antitrypsin is obtained from healthy plasma donors.     There have been studies in Islet Transplant in monkeys using this medication and it has shown     to protect the islets from inflammation.      This study involves using Alpha-1 Antitrypsin in addition to our current Standard of Care     medications used in Islet Transplant.   "
63455|NCT02455050|"     A study to evaluate the tolerability and acceptability of an investigational eye drop     formulation in patients with Dry Eye Disease.   "
58485|NCT02520063|"     This study will test how well a new combination of three drugs (Letrozole, Everolimus, and     TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to     definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers     while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational     drug that blocks the formation and growth of blood vessels that feed the cancer and promote     its growth. The goal of this study is to investigate the safety and efficacy of this     multitargeted approach in breast cancer.   "
58486|NCT02520050|"     The American Diabetes Association (ADA), among other medical societies, is strongly     recommending medical nutrition therapy (MNT) for prevention and management of type 2     diabetes. However, the ADA recognized that there is no one size fits all diet and thus     recommends that MNT should be conducted through a consultation with registered dietitians     (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an     integral part of the MNT, lowers postprandial blood glucose levels. Through our experience     from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying     MNT within a structured dietary intervention protocol has the best impact on blood glucose     values and body weight. Meanwhile, the frequent use of health coaching during dietary     intervention proved to be effective in managing diabetes and inducing weight loss. However,     no study compared those three intervention methods in a randomized clinical study.      The aim of this study is to evaluate the effect of different models of conducting medical     nutrition therapy on the glycemic control in patients with type 2 diabetes.   "
58487|NCT02520037|"     Fluids are generally administered to patients in order to improve circulation. However,     fluids do not always improve circulation and fluids have side effects. Unfortunately, it is     difficult to predict whether fluid administration improves the circulation, i.e. it is     difficult to predict fluid responsiveness The overall aim of this observational study is to     investigate if analysis of spontaneously occuring extra systoles can give the answer: The     second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has     experienced the compensatory pause, i.e. this beat is associated with increased filling time     and in turn associated with increased filling. As such, the post ectopic beat shows how the     heart responds to increased filling. Therefore, the hypothesis of this study is that the     hemodynamic response to the increased filling at the post ectopic beat (compared with sinus     beats) can predict fluid responsiveness   "
58488|NCT02520024|"     This project proposed to demonstrate the effectiveness, costs, and benefits to participation     and community living self-directed care programming within a financially sustainable Medicaid     managed care environment. The study examined outcomes associated with the implementation of a     novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in     which consumers were able to access a set amount of renewable funds per year and direct how     they were spent, both to purchase the types and amounts of rehabilitation and treatment     services they desire (and from whom they choose) and to purchase a broad-range of     individualized resources and services that are generally outside of Medicaid funding (e.g.,     health club memberships, yoga classes, support in taking care of bills).   "
58489|NCT02520011|"     The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete     Remission) to FLAM compared to AM treatment in refractory or relapsed AML patients with     demonstrated NOXA BH3 priming of ≥ 40% by mitochondrial profiling in bone marrow.   "
58490|NCT02519998|"     The purpose of this study is to prospectively collect a comprehensive, multi-modality set of     diagnostics on patients who have had a concussion, repeating some of these tests serially     over time, so that the investigators may then in the future perform retrospective data mining     to determine if there were a biomarker or risk calculator that could be used to guide     return-to-play and other medical decisions.   "
58491|NCT02519985|"     The purpose of this study is to evaluate the repeatability and reproducibility of corneal     (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment     measurements using the ArcScan Insight 100 very high-frequency digital ultrasound     arc-scanner.   "
58492|NCT02519972|"     Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung     cancer. Relatives with family history of lung cancer are at increased risk of lung cancer     compared to those without a family history in pooled analysis. A prospective trial using LDCT     of lung to screen the relatives with family history of lung cancer is needed.   "
58493|NCT02519946|"     Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their     long-term outcomes and survival. Currently, no effective cardiovascular preventative care is     provided for this pediatric population, in part, due to the fact that clinic-based programs     are not easily accessible to children and their families. However, tele-health has been show     to improve medical outcomes by making care more accessible to these patients. This study aims     to meet the urgent need for an effective and sustainable delivery of preventative care to     pediatric heart transplant patients using a diet and exercise intervention program delivered     live over the internet direct to these patients' homes.   "
58494|NCT02519933|"     A well-functioning vascular access is essential for effective hemodialysis. The native     arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis     and infection risks compared to either synthetic arteriovenous grafts or central venous     catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic     arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no     suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the     antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise     proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also     associates with severe arm swelling and pain. Thus, the investigators introduced a novel     modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term     hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried     out.   "
58495|NCT02519920|"     This study was to test an appropriate dose of fluorescein sodium which can provide high image     quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized     blinded controlled trial.   "
59063|NCT02512445|"     The goal of this project is to determine if a 6-session psychotherapy intervention will help     Veterans feel less deployment-related guilt and less distress related to their guilt. Half of     the participants will receive the guilt focused intervention and half will receive a     supportive intervention.   "
58496|NCT02519907|"     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously     difficult to treat. Amputation usually follows traumatic injuries or surgery following     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is     required for the survival of the patient. The loss of a limb or other body parts is usually     followed by the sensation that the lost body part is still present and can be felt. These     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure     on the residual limb) and psychological factors (e.g. emotional stress). It is well known     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,     psychological and other, are ineffective.      Today it is believed that phantom limb pain may be related to changes in the cortex of the     brain. There is evidence that these changes may be modulated - or even reversed - by     providing sensory input to the stump or amputation zone. For example, cortical reorganization     and alleviation of phantom limb pain has been observed in amputees following intense use of a     hand prosthesis. However, there is no consistent knowledge on which type of peripheral     sensory feedback may be effective in affecting the cortical plasticity or on how to best     apply the sensory feedback.      The aim of the proposed research is to create natural, meaningful sensations through     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.   "
58497|NCT02519894|"     Introduction :      Due to Chronic kidney disease is a public health problem, which is important increased in     both developed and developing countries . And sodium intake restriction was related to the     reduction of blood pressure and urine protein which is one of the important risk factor in     chronic kidney disease. One of the problem in sodium restriction failure in Thai population     with CKD nowadays is lack of knowledge and problem unawareness.      The study hypothesis :      Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be     simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR     reduction rate      Objectives :      To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between     CKD patients receiving strict controlled combined with immediate individual feedback (DISC     Progrram) and those receiving standard education.      Study design :      Multicenter, open labeled, parallel, randomized controlled trial      Sample size : 600      Primary outcome : GFR reduction (CKD-EPI)      Secondary outcome :        -  Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)        -  Blood pressure difference        -  Proportions of patients with BP reached the target (130/80 mmHg)        -  Number of anti-hypertensive drugs use to achieve BP target        -  Urine albumin/creatinine ratio        -  Major Adverse Cardiac Events (MACE)        -  Cardio-ankle vascular index (CAVI)        -  ankle-brachial index (ABI)      Documentary Proof of Ethical Clearance :      This project has been reviewed and approved by the Comittee on Human Rights Related to     Research Involving Human Subjects , based on the declaration of Helsinki   "
58498|NCT02519881|"     This study was designed to evaluate the efficacy and safety of a modified microfracture using     collagen, and to compare them with those of a simple microfracture in patients with cartilage     defects in their ankles.   "
58499|NCT02519868|"     High blood pressure, also referred to as hypertension, affects about 65 million people in the     United States alone. Approximately 25 percent of people with hypertension cannot control     their high blood pressure, despite the use of multiple medications. Recently, new evidence     has demonstrated that the carotid body (CB) plays a role in essential refractory     hypertension, possibly due to a deregulated, enhanced activity of this organ. Animal studies     showed that CB de-afferentiation, through carotid sinus nerve denervation, leads to a     long-term stable drop in blood pressure in spontaneously hypertensive rats. De-afferentiation     may be performed either by injecting local anesthetics or by electrical stimulation. Both     techniques are daily used in the operating theater to anesthetize nerves for a wide range of     surgical procedures. We hypothesize that blocking CB with local anesthetics will result in a     drop of the blood pressure in refractory hypertensive patients. We also want to test the idea     that stimulating the CB with an electrical current will mislead the CB and will also result     in a drop of the blood pressure.   "
58500|NCT02519855|"     The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211)     administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine     (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the     noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella     zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of     geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the     noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza     virus strain-specific GMT antibody responses.   "
58501|NCT02519842|"     The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517)     plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea     and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s)     associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s)     not previously tolerated due to vomiting. The primary hypothesis is that a single dose of     fosaprepitant in combination with ondansetron provides superior control of CINV compared to     ondansetron alone as measured by the percentage of participants with a Complete Response (no     vomiting, no retching, and no use of rescue medications) in the delayed phase (>24 to 120     hours) following initiation of emetogneic chemotherapy in Cycle 1.   "
58502|NCT02519829|"     Patients undergoing primary hip arthroplasty will be randomized to receive either monocryl     closure of fascial and dermal layers with dermabond and tegaderm covering versus standard     vicryl closure of fascia layer and staple closure for skin. Short term wound complications,     pain and patient and surgeon-rated cosmetic scar appearance will be measured. The     investigators will also measure operating room time and costs associated with dressing     changes and wound-related procedures (e.g. staple removal).   "
58503|NCT02519816|"     Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with     steroid-refractory or dependent chronic graft vs host disease.      Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks.     Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell     depletion and Regulatory T-cell Expansion)   "
58621|NCT02518269|"     The study is designed to compare three articulation options in terms of osteolysis, patient     satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score     (HHS)) and safety.      In addition, the purpose of the study is also to evaluate the safety and effectiveness of     patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary     total hip arthroplasty.   "
58504|NCT02519803|"     Title: A Prospective Household observational cohort study of Influenza, Respiratory Syncytial     virus and other respiratory pathogens community burden and Transmission dynamics in South     Africa (The PHIRST Study) This study will improve understanding of the community burden of     influenza, RSV, pertussis, tuberculosis and pneumococcal infection in South Africa. It will     also provide data on the carriage prevalence of meningococcus and diphtheria. The data     generated from this study will also provide important information on the transmission     dynamics of influenza, RSV, pertussis and pneumococcus in the community allowing to better     strategize interventions (including targeted vaccination strategies) and evaluate their     potential impact. Moreover, there is an absence of prospective data on tuberculosis infection     from high tuberculosis burden countries. The data generated will both inform modelling of     transmission, sample size for prevention studies and surveillance assessing the impact of the     National Tuberculosis Control Program.   "
58505|NCT02519790|"     The purpose of this study is to explore the way the antidepressant concentration (amount of     medication) in the blood changes due to the physiological changes in the body (i.e., changes     in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of     genetic factors on the degree of these changes. Changes in antidepressant concentration are     important to monitor, as decreases in antidepressant concentration may lead to less than     therapeutic drug levels, which may cause an increase in mood symptoms or recurrence of     depressive episodes. Increases in antidepressant concentration have the potential to lead to     increased side effects. The study team is hoping to better understand the course of these     changes across pregnancy and postpartum and how an individual's genetic makeup impacts these     changes with the goal of developing guidelines to optimize antidepressant treatment of     pregnant women.   "
58506|NCT02519777|"     People infected with HIV often have cognitive dysfunction even if they are on antiretroviral     therapy (ART) and have undetectable viral loads. The purpose of this study is to evaluate if     the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV]     medications) to participants' existing ART regimens will improve participants' neurocognitive     performance.   "
58507|NCT02519764|"     The main objective of this study is to evaluate the impact of a hydration protocol at     thirst compared to other not at thirst hydration protocols on the changes in serum sodium     in runners of the Ultra Trail Mont-Blanc (UTMB) in 2015.   "
58508|NCT02519751|"     Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of muscle     mass. The method uses a dose of deuterium-labelled creatine to determine total skeletal     muscle mass via estimation of total body creatine pool size.The aim of this study is to     compare estimates of total body skeletal muscle mass by D3-creatine dilution method and whole     body Magnetic Resonance Imaging (MRI) in an athletic population.   "
58509|NCT02519738|"     Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common     problem seen in the pediatric surgery population. There is no standard treatment that has     been identified in clinical practice to treat granulation tissue effectively. Clinicians     prescribe treatments of varying nature to help treat this condition. By conducting this     study, the investigators hope to identify if there is any difference in the treatment groups     and if there is any superiority for one treatment over the other. The three arms in the study     are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will     continue over a period of three weeks, and the progress will be followed using surveys and     photographs.   "
58510|NCT02519725|"     The purpose of this study is to assess the influence of an ICU diary implemented during the     ICU stay on the psychological well-being of patients and families after ICU discharge.   "
58511|NCT02519712|"     The purpose of this study is to test a method of bone marrow transplantation that results in     only temporary donor immune function. In other words, the donor immune cells are given in a     way that will allow them to attack leukemia briefly before being destroyed by their own     immune system, or rejected. The investigators want to test whether temporary donor immune     function is enough to improve the odds of achieving a remission without exposing the patient     to the toxicities of a full bone marrow transplant. To do this, the investigators will use     standard chemotherapy for AML followed by an infusion of donor stem cells. The donor will be     a family member who is haploidentically, or half matched, to the patient such as a child or     sibling. Chemotherapy designed to treat AML should not be strong enough to prevent them from     rejecting the donor stem cells. The investigators will then follow the patient to see how     long the donor stem cells stay in them. The study will test whether this process is feasible     and can result in improved chances of obtaining a remission.   "
58512|NCT02519699|"     The optimal levels of mean arterial pressure that must be achieved in septic shock are     subject of debate. Studies tried to correlate blood pressure increase in patients with septic     shock with microcirculation. However, there are few studies that specifically assessed septic     shock patients with previous arterial hypertension. The main objective of this study is to     evaluate the effect of increased blood pressure level in the microcirculation of these     patients and compare them with patients without arterial hypertension.   "
58513|NCT02519686|"     The purpose of this study is to determine if the trendelenberg (TD) position (position in     procedures that involves placing the patient at an angle so that their head is lower than     their feet on the procedure bed) in select patients undergoing colonoscopy is superior than     the left lateral (LL) position (patient laying on their side, traditionally used for     colonoscopies) in terms of decreasing time necessary to pass the colonoscope through the left     colon, and decreasing the difficulty of the procedure.   "
58523|NCT02519556|"     Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or     relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The     hypothesis that an appropriate early stimulation of the intestinal flora contributes to the     establishment of the immune system balance has led to the use of probiotics in the prevention     and treatment of AD in several clinical and experimental studies.      Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of     probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD     (scoring atopic dermatitis) and to evaluate the effects of this medication in the following     laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation     composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor     necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth     factor beta [TGF - β]).   "
58514|NCT02519673|"     In refractive surgery, stromal ablation depth is fundamental because it determines the     thickness of the residual posterior wall. The posterior wall is an essential element that     guarantees the refractive stability and the long term prevention of corneal ectasia after     corneal refractive surgery. A minimum thickness of more or less 300 microns is universally     accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.      With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a new     treatment option called wavefront optimized is offered for myopia, astigmatism and     hyperopia. The ablation profile has been developed to save stromal tissue consumption and to     favor the quality of vision, by optimizing connections between the optical zone and the     transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the     depth of ablation may be defined by differential ultrasonic pachymetry or by topographical     analysis pre and postoperatively. The latter is currently the method of reference to assess     the corneal thickness.   "
58515|NCT02519660|"     Needle-related procedures are among the most common sources of pain and distress for children     in the health care setting. More than 50% of children reported pain during these procedures.     The necessity for pain management during these procedures is well established. Topical     anesthesia has been shown to be effective in managing needle-related pain. Eutectic mixture     of local anaesthetic (EMLA) cream is the topical anesthetic most used. The application of     this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. To     be effective EMLA cream must be applied for at least 60 minutes before needle procedure. This     is the major limitation for its use in emergency settings.      Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and     tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its     application. Only one randomized controlled trial compared the two topical anaesthetics in     children during venipuncture and showed that Ralydan patch led to superior analgesia than     EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes     before needle procedure. No differences were found in success rate of the procedure and vein     visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after     60 minutes from application.      To the best of the investigators' knowledge there is no published study that compared needle     procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine     patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect.      The aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum     analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the     first attempt and pain relief in children.   "
58516|NCT02519647|"     Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite     is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the     efficacy of a new designed bougie for intubation in patients with simulated difficult     airways.   "
58517|NCT02519634|"     Shock wave lithotripsy (SWL) is recommended for kidney stones < 20 mm. However, the stone     clearance of lower pole calculi after SWL is limited, thus leading to an extended indication     for mini-percutaneous nephrolithotripsy (PCNL) even for stones between 10 and 20 mm in many     centers. This trend is further promoted by introduction of super-mini PCNL (SMP), which is     postulated to be less invasive compared to mini-PCNL due to the miniaturized instruments.     However, this issue remains controversial.      On the other hand, improvements in endoscopy technology have made retrograde stone removal     more attractive. This has led to an increasing use of RIRS as a primary treatment although it     is recommended only as 2nd-line option by current guidelines. However, the treatment of     symptomatic lower pole calculi is a challenge for RIRS because of lower clearance rates.      The purpose of this study is to evaluate the efficacy and safety of SMP and RIRS for the     treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.   "
58518|NCT02519621|"     This study is designed to assess the efficacy and economics of two NPWT branded devices of     wound healing outcomes. It is also designed to assess the effectiveness of negative pressure     and negative pressure with continuous irrigation on multiple parameters of wound healing. It     is a single-center, open-label, active controlled, parallel-group trial that aims to     determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic     foot ulcers. Specifically, eligible participants will be randomized to receive either PRO     negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without     irrigation; or KCI Ulta negative pressure therapy.   "
58519|NCT02519608|"     This is an investigator-initiated, prospective, single-centre, randomised, phase II,     open-label study, testing the superiority of ticagrelor, as compared to clopidogrel, in     modulating on-P2Y12 treatment platelet reactivity, endothelial dysfunction and inflammation     in chronic obstructive pulmonary disease (COPD) patients receiving scheduled percutaneous     coronary intervention (PCI) for stable coronary artery disease. Subjects that meet the     inclusion criteria and have provided informed consent will be randomly assigned in a 1:1     fashion to one of the two dual antiplatelet therapy (DAPT) regimen: aspirin + clopidogrel     (standard of care) vs. aspirin + ticagrelor (experimental arm).      DAPT with aspirin and clopidogrel for at least 6 months (preferably 12 months) is the current     gold-standard for patients receiving PCI and drug eluting stent implantation for SCAD. No     data supports a different strategy and/or approach in COPD patients undergoing PCI.     Ticagrelor, a new P2Y12 inhibitor, showed a significantly higher platelet inhibition as     compared to clopidogrel. Recently, ticagrelor administration has been associated with a     positive effect on endothelial function and a modulation of proinflammatory signalling. These     actions are mediated by a significant influence of adenosine uptake. Higher platelet     reactivity, chronic inflammatory response, heightened endothelial dysfunction characterized     COPD patients with concomitant coronary artery disease (CAD). The investigators speculated     that COPD patients undergoing PCI for stable CAD (SCAD) had a risk profile similar to that of     acute coronary syndromes (ACS) patients. Accordingly, COPD patients undergoing PCI for SCAD     may obtain a stronger benefit by ticagrelor as compared to clopidogrel. The aim of this study     is to evaluate whether ticagrelor, is superior to clopidogrel, in reducing endothelial     dysfunction , platelet reactivity (PR) and inflammation profile of patients with stable CAD     and COPD. Ticagrelor will be administered according PLATO trial and international guidelines     (180 mg as loading dose, 90 mg x 2 daily as maintenance dose). As suggested by international     guidelines, the control group will be patients with current gold standard treatment for SCAD     treated with PCI (aspirin + clopidogrel 75 mg daily). The evaluation of endothelial     dysfunction, PR and inflammation profile will be repeated after 30 days and will be compared     to baseline values.   "
58520|NCT02519595|"     There is a wide variation of published IV ketamine dosing regimens used for procedural     sedation in children in the Emergency Department (ED). The purpose of the study was to     compare the efficacy, duration of sedation and adverse events between the three commonly     administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional     administration method of 30-60 second infusion for ED sedation in children.   "
58521|NCT02519582|"     Phase II trial evaluating the safety and efficacy of oral appliqued niclosamide in patients     who are progressive with metachronous or synchronous metastases of colorectal cancer among     the previous therapy (Nikolo). Monocentric open-label clinical trial of phase II. All     patients received 2 g p.o. niclosamide daily until progression (according to RECIST) or     unacceptable toxicity or discontinuation of study for other reasons.   "
58522|NCT02519569|"     A considerable proportion of bereaved individuals experience chronic and disabling grief     (so-called complicated or prolonged grief). Complicated grief is associated with severe     mental and physical health problems as well as impaired social and occupational functioning.     Interventions based on cognitive-behavioral therapy and applied via the internet have shown     to be efficacious for this condition, but have not yet been adapted and evaluated in Norway.     The aim of the current study is to adapt an internet-based cognitive-behavioral intervention     for complicated grief and evaluate its effectiveness as a pilot study.   "
58526|NCT02519517|"     Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy.     Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV)     and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35     mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min     post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH     >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures analysis     of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is     considered statistically significant.   "
58527|NCT02519504|"     The purpose of this study is to learn about Duarte galactosemia (DG). This study will examine     the possible effects of Duarte galactosemia (DG) in children, and determine whether dietary     exposure to milk in infancy or early childhood is associated with developmental outcomes of     school-age children with Duarte galactosemia (DG).   "
58528|NCT02519491|"     Accessing the arteries of the heart through the blood vessels of the wrist is becoming     increasingly popular. By obtaining access via the artery in the arm as opposed to the groin,     there is less risk of complications and improved patient satisfaction. However, using the     wrist can cause blockage of the artery after the procedure. If there is too little blood flow     from a second artery that supplies the hand, this could result in significant injury.     Therefore, it is important to test these blood vessels in the wrist prior to having this     procedure. The best way to evaluate these arteries involves the use of ultrasounds but this     takes a long time and is expensive. Therefore, the artery is usually evaluated with a     clinical test known as the modified Allen's test, which relies on the doctor watching the     flushing of the hand during compression of the artery. Currently smart phones with cameras     are able to assess blood flow by passing light through the skin and watching differences in     brightness. This may be a better way to assess the arteries in the hand as it is less     subjective than simply watching the flushing of the hand. This study aims to assess the     ability of an iPhone application in determining whether there is sufficient blood flow     through the arteries of the wrist and comparing it to the clinical test commonly used.   "
58529|NCT02519478|"     The purpose of the study is to determine the effectiveness of the helmet-less tackling     training (the HuTT Technique) intervention to reduce head impacts in high school football     players and to gain an understanding of the neurocognitive effects of repetitive head impacts     in football. The investigators hypothesis is that the HuTT Technique will result in a reduced     frequency and magnitude of helmet impacts than the control group measured by a head impact     measurement system. Also, the investigators hypothesize the HuTT Technique group will     demonstrate less changes in neurocognitive scores in the mid and post season evaluations     compared to the control group. Head impacts will be measured using the SIM-G impact monitor     made by Triax Technology. The SIM-G impact monitor measures the location, magnitude, and     direction of every head impact in real time and is stored on a protected cloud-based system.     The sensor is worn by each athlete in a headband or skullcap. Neurocognitive function will be     measured using the Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) test.     The test is used as a tool to determine baseline neurocognitive function and is used in     comparison if an athlete was to be injured to ensure he/she returns to baseline. ImPACT     measures memory (verbal, visual, working), processing speed and reaction time using a variety     of tests. Subjects will be recruited from local high school football teams and will include     freshman, sophomores and juniors. Since the study is expected to run for 2 years, seniors     will not be eligible for participation. The target is to recruit at least 150 total subjects.     All subjects will be equipped with a new helmet that is fitted to their head and a headband     that will be used to hold the head impact telemetry sensor. In addition, all subjects will     take an ImPACT test preseason, midseason and postseason. At the conclusion of each season,     all of the impacts from the SIM-G impact monitor system and ImPACT test scores will be     analyzed. The relevant outcome measures to be analyzed include head impact frequency,     location, magnitude, symptom scores, memory, visual motor speed and reaction time composite     scores. Statistical analysis will be used to determine if the HuTT intervention minimized     head impacts and neurocognitive decline compared to the control group.   "
58530|NCT02519465|"     The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal     interface have been employed in an attempt to relieve respiratory distress and optimize the     deposition of drugs by inhalation.      Some studies report the effects of NIV association with fogging in healthy subjects,     asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist     interface and therapy are scarce and most are found in vitro and animal models. The objective     of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow     nasal interface system with vibrating mesh nebulizers using in healthy adults.   "
58531|NCT02519452|"     The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture of     daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC)     delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation) administration     via SC delivery of daratumumab (Part 2).   "
58532|NCT02519439|"     A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult     patients with drug-resistant partial-onset seizures   "
58533|NCT02519426|"     The study evaluates and validates a new classification proposed by Juodzbalys and Daugela in     2013 predicting the complexity of impacted mandibular third molars surgical extraction,     comparing it with other two, scientifically approved (Pell and Gregory, Winter)     classifications.   "
58534|NCT02519413|"     The primary objective of the study is to retrospectively investigate changes in lymphocyte     counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on     Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in     lymphocyte subtypes other than CD4+ and CD8+ T cells.   "
58535|NCT02519400|"     A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline,     25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and     cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma     concentrations of amitriptyline, nortriptyline, and their metabolites. Various     pharmacodynamic markers related to the adverse event of amitriptyline will be measured     serially during the study.   "
58538|NCT02519361|"     Aging cause specific changes in the immune system. Processes like immunoessence and     inflammaging offend the functioning of the immune cells and expose the elderly patient to     infections that can lead to morbidity and death.      Protein translation regulation offers a strategic advantage to the immune cells, because it     enables rapid activation or termination of synthesis of specific proteins, required for     inflammation or its resolution. Translation initiation depends on recruitment of eukaryotic     initiation factor eIF4F complex.      The aim of the current study is to investigate the involvement of the translation initiation     factors (eIF4E and eIF4G) in the process of recovery from acute infection in elderly patient     admitted to the internal department with an acute infection.   "
58565|NCT02519010|"     Comparative randomized, single dose, two-way crossover open-label study to determine the     bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets     (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma, USA).   "
58540|NCT02519335|"     Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow     the surgeon to perform heart operations. However, these processes can cause injury to the     heart which may worsen post-operative outcomes. In fact, the effects of these injuries may     continue after surgery, and lead to a long-term decrease in heart function. Neonates and     young infants are at particular risk for this occurrence.      While much research has been done in adults looking for medicines that might protect the     heart during surgery, few studies have been conducted in neonates and young infants. The     investigators are testing Dexrazoxane, which has proven to be cardio-protective in pediatric     cancer patients, in the hope that it may lessen cardiac injury during and after congenital     heart surgery, and thereby improve outcomes in the neonatal and young infant population.      In order to accomplish this, the investigators must first determine how Dexrazoxane can be     safely administered to young children with congenital heart disease. Therefore, the     investigators are performing a pilot study of 12 children to assess:        1. how Dexrazoxane at 3 different doses is metabolized in the body of a child age 0-6          months during and after congenital heart surgery, and        2. the safety of Dexrazoxane use in the neonatal and young infant population undergoing          cardiac surgery.   "
58541|NCT02519322|"     You are being asked to take part in this study because you have melanoma that is metastatic     (has spread) and you are going to have surgery to remove the disease.      The goal of this clinical research study is to learn if giving nivolumab alone or in     combination with ipilimumab before and after surgery can help to control metastatic melanoma.     The safety of these drugs will also be studied.   "
58542|NCT02519309|"     The primary purpose of this research is to demonstrate the therapeutic effects on diabetes,     pre-diabetes and metabolic syndrome of implementing a well-formulated low carbohydrate     lifestyle program.   "
58543|NCT02519296|"     In this article, the investigators report the design and protocol of a functional magnetic     resonance imaging study (fMRI) of the treatment of Danish veterans with PTSD with Prolonged     Exposure Therapy (PE). In total 30 Danish veterans will be recruited, who meet the ICD-10     diagnostic criteria for PTSD, and treated with PE. A group of controls will be recruited     consisting of age-appropriate same sex veterans who have participated in international     missions similar to the patient group   "
58544|NCT02519283|"     Approximately 20-30% of patients presenting with acute heart failure are discharged from the     ED. Compared to patients discharged from the hospital, they more frequently return to the ED     and hospital for further management. While inpatient discharges are often enrolled in     transitions programs and have their care tailored to evidence-based recommendations, ED     discharges do not. The investigators propose to evaluate current standard ED discharge to an     ED-based intervention which will transition patients to outpatient follow-up on     guideline-recommended therapy.   "
58545|NCT02519270|"     A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and     Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with     Refractory Non-Hodgkin Lymphoma (NHL)   "
58546|NCT02519257|"     Atherosclerosis is an inflammatory process in which immune mechanisms interact with metabolic     risk factors to initiate, propagate, and activate lesions in the arterial trees and is known     as the main cause of coronary artery disease (CAD). Recently, there are more and more studies     highlighted the potential importance of adipose tissue in relation to inflammation effects on     CAD pathogenesis. However, it remains unclear whether Thy-1, adiponectin or any other     inflammatory mediators in mediastinal adipose tissue contribute to CAD. In this study, we aim     to analyze the expression of inflammatory mediators' expression via in vitro assay (3T3-L1     cell culture) and in vivo assay (human adipose tissues).   "
58547|NCT02519244|"     The purpose of this study is to investigate whether a wearable robotic exoskeleton can help     people with multiple sclerosis (MS) to walk again.   "
58548|NCT02519231|"     Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper     IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory     medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did     not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available     NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot     trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or     spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7     days of menstruation for three consecutive cycles, and then observed for one cycle without     treatment.   "
58550|NCT02519205|"     The purpose of this study is to determine how the length of a triage shift (i.e. 4 vs., 8     vs., 12 hours) affects fatigue levels among triage nurses in the Emergency Department (ED).   "
58645|NCT02517957|"     On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter,     randomized, double-blind, controlled trial of design type. Objective, normative evaluation of     traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in     the treatment of eczema, security, and control of the relapse of situation, provide     high-level evidence-based basis for traditional Chinese medicine treatment of eczema, aims to     form suitable for popularization and application of traditional Chinese medicine in the     treatment of eczema.   "
58551|NCT02519192|"     This study hopes to determine if a negative pressure dressing is superior to a traditional     dressing for speeding fistula closure after laparotomy. This study has a broad variety of     implications. Patient safety is a paramount concern: Investigators hope to identify a     superior method of wound management which minimizes risk for skin breakdown, sepsis, and     morbidity. In addition, patient satisfaction would be improved with a method for faster wound     healing. Finally,implications exist in the realm of a cost-benefit analysis, for example,     although the VAC method is more costly, it may save money if it speeds healing and prevents     the need for reoperation. Alternatively, if the VAC method is not shown to be beneficial,     physicians can avoid using a more costly device with no proven benefit.   "
58653|NCT02517853|"     The aim of this study is to evaluate the efficiency of the Neuroestimulation of the Posterior     Tibial Nerve for the treatment of this syndrome.      A multicentric, prospective, randomized study will be performed in patients affected with     severe LARS symptoms. Patients will be randomized in two groups:        1. Control group- placebo        2. Treatment group: neuroestimulation of the posterior tibial nerve   "
58552|NCT02519179|"     The objective this research is to conduct a within-subject, experimental study that will     describe mothers' feeding practices during typical bottle-feeding conditions and will examine     whether removal of visual cues related to the amount of milk/formula in the bottle will alter     these feeding practices. The investigators hypothesize that mothers will show higher levels     of infant-directed feeding practices and lower levels of mother-directed feeding practices     when using opaque, weighted bottles compared to when using standard, clear bottles. The     investigators also hypothesize that infants will consume less breast milk or formula when fed     from opaque, weighted bottles compared to when fed from standard, clear bottles.   "
58553|NCT02519166|"     In this prospective observational study, the investigators tried assess the presence of     biofilm on chronic wound samples coming from a large cohort study of patients, whilst     cross-referencing the clinical, bacteriological and wound care observations.   "
58554|NCT02519153|"     Urolithiasis is one of the most common urological diseases. The risk of urolithiasis is     estimated to be between 5% and 12% all over the world with increased incidence in male rather     than female (2:1) respectively . Ureteral stones account for 20% from all urinary tract     stones, more than 70% of the ureteral stones found in the lower third of the ureter . The     incidence of urinary stones has been increasing day by day. Medical expulsive therapy (MET)     of ureteral stones is the investigators' concern in this study. Stone location, size, number,     ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors affecting     passage of the ureteral stones. So, MET is based on mechanism that stone passage is     facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure     proximal to the stone and decreasing exciting edema . There are many oral medication could be     used as MET such as adrenergic blockers, calcium channel blockers, prostaglandin synthesis     inhibitors, glyceryl trinitrate and steroid treatment . Calcium-channel blockers and     adrenergic α-antagonists are the main that has been proposed to enhance stone passage as     expulsive medical therapy. Cyclic nucleotides are degraded by phosphodiesterases enzymes     (PDEs). So using of PDE inhibtors may play role in relaxation of smooth muscle of the ureter.     A study was done for evaluation of three PDE5 inhibtors, sildenafil , vardenafil and     tadalafil, they found that PDE5 inhibitors can reverse the tension of isolated human ureteral     smooth muscle via cGMP-mediated pathways.   "
58555|NCT02519140|"     This is a study to determine how the viscosity (thickness) of an FDA approved gel made by     Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of     endoscopic surgery performed for localised cancer - can be performed when the gel is injected     submucosally. The lifting characteristics of the gel will be assessed by height and diameter     and ease with which the subsequent EMR dissection can be performed. These characteristics     would be assessed on excised human stomachs and colon, which are harvested during routine     sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.   "
58556|NCT02519127|"     This study is testing the effectiveness of a dietary intervention by means of measuring the     change in RQ upon a hyperinsulinemic euglycemic clamp challenge and by means of measuring the     kinetic responses of multiple PF markers (including RQ) to an acute mixed meal challenge     before and after a 6-week dietary intervention. The challenges will be applied to investigate     whether the kinetic response is a better measure for health and wellbeing when compared to     fasting (baseline) levels. In addition, several measures that reflect perceivable benefits     like mood, quality of life, sleep quality, cognitive and physical performance will be     assessed in a first exploratory attempt to link (changes in) PF to consumer perceivable     benefits.      Subjects will be randomly allocated to a low glycemic load diet or a 'Western' diet for 6     weeks. Before and after the intervention several measurements will take place. The low     glycemic load diet will be high in polyphenols, protein, vegetables, pulses, fibres and nuts,     and low in glycemic carbohydrates. All these dietary factors have been shown to improve     glycemic control and/or to reduce metabolic syndrome risk factors.   "
58557|NCT02519114|"     The aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with     post-transplant cyclophosphamide will improve progression free survival in poor risk multiple     myeloma patients.   "
58559|NCT02519088|"     The study evaluates the patient related risk and predictive factors concerning perioperative     homologous blood cell transfusion (erythrocyte concentrate ) in THA patients in one EndoCert     max-certified orthopedic hospital in Germany.      A patient oriented preoperative decision-making algorithm (a personalised Patient Blood     Management or pPBM App) will be developed as a new patient-safety blood-sparing strategy.      The aim is to increase the patient safety by using the pPBM App and to reach a more efficient     management of resources.   "
58560|NCT02519075|"     Prospective exploratory study specifically investigating the diagnostic and predictive role     of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and     candidate to TARE. A minimum number of 20 patients will be considered for the analysis.   "
58561|NCT02519062|"     This is a retrospective study that involves the revision of clinical, instrumental and     pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with     surgery with radical intent at our center.   "
58562|NCT02519049|"     Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT     imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to     pleurodesis.   "
58563|NCT02519036|"     This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of     multiple ascending doses of IONIS-HTTRx administered intrathecally to adult patients with     early manifest Huntington's Disease.   "
58564|NCT02519023|"     Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally     invasive way in which to remove the uterus, which has less scarring and fewer complications.     However, this procedure, much like its open-surgical counterpart, is often associated with     significant post-operative pain. To augment this pain there are many different analgesic     techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP)     block is one such procedure involving the injection of a local anesthetic into the plane of     the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet     different analgesic approach is that of direct injection of local anesthetic into the     incision by the surgeon during or just after surgical procedures. These two approaches have     both been proven to decrease post-operative pain in patients for many procedures, but never     compared to one another.   "
58566|NCT02518997|"     Reading to children is believed to be beneficial to cognitive and mental development.This     study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to     bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen     levels. The investigators will follow rates of common preterm health issues while in the     hospital and time to hospital discharge. Effects of bedside reading on parental stress and     infant bonding will be measured and compared to usual rates of these indicators to determine     if reading to babies reduces stress and enhances bonding.   "
58567|NCT02518984|"     Given the advances in Atrial Fibrillation (AF) management and the availability of new     European Society of Cardiology (ESC) guidelines, there is a need for the systematic     collection of contemporary data regarding the management and treatment of AF in the member     ESC countries. It is now nearly 10 years since the last European registry of AF management     was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was     needed.   "
58568|NCT02518971|"     The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence     of postoperative urinary retention in primary total knee and hip arthroplasty patients.   "
58569|NCT02518958|"     This is a dose escalation protocol to determine the feasibility of co-administration of     RRx-001 and nivolumab. Immune surveillance is an endogenous mechanism to cause remission of     neoplastic growth. Epigenetic agents like RRx-001 are associated not only with enhanced gene     transcription and restored expression of silenced genes but also with increased expression of     pro-inflammatory mediators, upregulation of PD-L1 on tumor cells and de-repression of     antigens that promote immune recognition of tumors. It is hypothesized that RRx-001, will     prime or sensitize to immune checkpoint therapy targeting PD-1 interaction with nivolumab.   "
58570|NCT02518945|"     This is a single center, prospective, randomized, double blinded placebo controlled study     conducted I patients with type 1 diabetes.The aim of this study is to examine the additive     effects of GLP-1 agonist and SGLT2 inhibitor in patients with type 1 diabetes in terms of     possible improved glycemic control, reduced glycemic variability, reduced insulin dosages,     additional effects of weight loss and blood pressure reduction.   "
58571|NCT02518932|"     To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.   "
58572|NCT02518919|"     The role of Adjunct therapies such as Child Life therapy and Music listening during     Procedural Sedation and Analgesia(PSA) for children during painful procedures has not been     studied in the Emergency Department (ED). The investigators hypothesize that there will be a     reduction in sedation medication dosage without change in sedation efficacy by addition of     music therapy and Child Life to standard sedation protocol in children 3-15 years of age who     undergo PSA for painful (orthopedic procedures, laceration repair, incision and drainage)     procedures in a Pediatric emergency Department (PED).   "
58573|NCT02518906|"     Specialized treatment of personality disorders (PD) in youth has been neglected for a long     time, because these disorders were not diagnosed before the age of 18. Since 2013 the age     threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change     is also announced for the International Classification of Diseases (ICD)-11. There is broad     consensus from both scientific evidence and clinical experience that specialized early     interventions in adolescents with PD are urgently needed.      In the last decades a number of specialized psychotherapeutic treatment programs have been     developed. Despite their conceptual differences, many of the treatment models have shown     significant effects in the treatment of PD in adults. However, the treatment of adolescents     with PD remains difficult and further enhancement and development of treatments is needed.      Given the different therapeutic approaches available, the present project aims to go beyond     the comparison of integral therapeutic models in the classical outcome study design. While     outcome research is important to build on the evidence of the effectiveness of an     intervention, it contributes little to its understanding and refinement. The aim of the     present multi-center project is to compare two therapeutic methods used in routine care:        -  Adolescent Identity Treatment (AIT)        -  Dialectic Behavioral Treatment for Adolescents (DBT-A)      Treatments will be performed at different study centers and compared using the same measures     of outcome. The main outcome will be psychosocial functioning.      Additionally, the psychotherapy process will be investigated to explore specific and     unspecific mechanisms of the therapeutic process, its outcome and mediators.   "
58574|NCT02518893|"     The purpose of the study is to describe service members' experiences as participants in     health research, including their reasons for deciding for or against research participation.   "
58575|NCT02518880|"     To understand the cardiovascular reactions of the human body to changing conditions of     gravity is an important aim of space science. In this context, cardiac output (CO) is a key     value to estimate the human cardiovascular system.      The main objective of this experiment is to determine the effects of parabolic flight on     intravascular volume, and how these changes modulate the complex haemodynamics induced by the     parabolas.   "
58648|NCT02517918|"     This is a prospective open-labeled phase I trial based on a dose escalating study design     assessing two dose levels of sirolimus when prescribed in combination with metronomic     cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion     cohort once the Maximum Tolerated Dose (MTD) is established.   "
58600|NCT02518555|"     This randomized phase II trial studies how well ibrutinib works when given together with     vaccine therapies in treating patients without clinical signs or indications that raise the     possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk chronic     lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Vaccines, such as pneumococcal     13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria toxoid/tetanus     toxoid/acellular pertussis vaccine adsorbed, may help the body build an effective immune     response to kill cancer cells. Giving ibrutinib together with vaccine therapies may be a     better treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.   "
58654|NCT02517840|"     The rise in life expectancy implies an increased number of nonagenarian patients who need     evaluation for critical lower limb ischaemia (CLI). The study goal is to evaluate whether     revascularization techniques in these patients fulfill a set of security and efficacy     criteria generated from surgical results in a validated historical cohort.   "
58576|NCT02518867|"     Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment of     neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive TMS     (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious     subjects through the intact scalp. The investigators hypothesize that excitatory rTMS applied     over the motor cortex would increase motor cortex activity and result in an increase in the     inhibitory input through the corticospinal tract to the spinal cord, thus reducing alpha     neuron hyperactivity and consequently clinical spasticity. In this study, the investigators     will apply the stimulation on the legs motor cortex area, which can cover supplemental motor     area (SMA). Therefore, not only the spasticity, but also the motor control of legs both can     be modulated by stimulation. Theta burst stimulation is a condition of rTMS which was     designed by the co-investigator. It has controllable, consistent, long-lasting, and powerful     effects on motor cortex physiology and behavior. The investigators therefore design this     protocol using theta burst stimulation on the motor cortex of the patients of cerebral palsy.     The investigators expect that there would be an effect on the reduction of spasticity after     rTMS on the brain of children with CP, thus improving the motor control of legs.   "
58577|NCT02518854|"     Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely     under-diagnosed in children and adolescents. Obesity and hypertension are two important     requirements for criteria of MetS. With early detection and early intervention of MetS in     children and adolescents will enable better care to reduce the heavy burden of health care     all over the world.      Investigators intend to recruit 150 children and adolescents age 6 to 18 yr with     overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to     reach the following research goals:      1) To identify biomarkers as risk factors; 2) To characterize that impact of vascular     assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular     assessment parameters, and metabolic phenotypes.   "
58578|NCT02518841|"     The investigators will compare Achilles tendon stretching with a new product called a     ThermaWedge™ device, a foam wedge designed to help with certain foot stretches and exercises,     in the treatment of chronic plantar fasciopathy. There will be 2 groups each of 25 - 30     participants who have chronic plantar fasciopathy, which is a common cause of foot pain.     Exercises will be done for 6 weeks and then each group will do the other exercise protocol     for another 6 weeks. Participants will fill out the Foot and Ankle Disability Index scale and     numerical analog pain scale and the Global Rating of Change Scale prior to any treatment,     weekly during treatment and post treatment. The investigators' hypothesis is that use of the     ThermaWedge™ device will result in decreased pain and disability when compared to achilles     tendon stretching.   "
58579|NCT02518828|"     The primary objective of this pilot trial is to determine whether inpatients presenting to     the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who     receive supplemental oxygen adjusted at either a high (SpO2 range ≥96%) or low (SpO2 range     90-92%) oxygen saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP)     at 72 hours.   "
58580|NCT02518815|"     This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic     surgery prevented inadvertent post-operative hypothermia. Treatment group received prewarming     using a forced air body warming, control group received no active warming system. Both groups     were then warmed with forced air warmer intraoperatively.   "
58581|NCT02518802|"     This randomized phase III trial is studying gefitinib and synchronous pemetrexed/cisplatin     chenmotherapy to see how well it works compared to pemetrexed/cisplatin chenmotherapy alone     in treating patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma     with EGFR activating mutation in Asian population.   "
58582|NCT02518789|"     By observing the difference of plasma homovanillic acid concentrations and brain electrical     consciousness monitoring Narcotrend index, study the possible mechanism of influencing     Etomidate induced myoclonus with Dexmedetomidine pretreatment during general anesthesia     induction period.   "
58583|NCT02518776|"     Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible     for physical disability but can also cause cognitive disturbances annoying social and     professional life of patients with the disease. Various studies have shown that there was a     breach of episodic memory, working memory, attention and executive functions regardless of     the form of disease, disability or duration of disease progression.      The main objective of this study is to investigate the influence of emotional components and     executive processes on the components retrograde and anterograde episodic memory (thanks to     an original paradigm based on the emotional valence of the memory) in MS patients   "
58584|NCT02518763|"     The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of     French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility     and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a     suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from     undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic     regimens, specific to each clinician in the absence of precise data in the literature. No     consensus on supplementation dosages and methods have been proposed so far. Also, given the     frequency of vitamin D deficiency including osteoporosis observed in the population, it     became necessary to establish a single, uniform regimen for all patients with osteoporosis   "
58598|NCT02518581|"     The present study is an exploratory trial to establish a feasible DLW (doubly labelled water)     protocol for implementation in clinical trials conducted at Profil Institut für     Stoffwechselforschung, investigating treatment options for overweight and obesity in     populations with and without diabetic comorbidity. The study aims at the practical validation     of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects.      Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as     calculated based on individual anthropometric measurements (including body composition) using     the Müller formula and the AEE (activity related energy expenditure) based on reported work     place and leisure time activities and (2) TEE as calculated from measured REE (resting energy     expenditure) as assessed by indirect calorimetry and the AEE based on information recorded by     the subjects in a physical activity diary and corresponding pedometer counts. Moreover, TEE     assessments will be repeated once (separated by 2-4 weeks) to determine intra-subject     variability / re-test reliability of the measurement.   "
58585|NCT02518750|"     This is a phase-II study to evaluate the efficacy of a salvage regimen in children with     relapsed T-cell ALL or lymphoma. Peg-asparaginase, mitoxantrone, intrathecal triples (IT)     (intrathecal methotrexate/hydrocortisone/cytarabine) (ITMHA) and dexamethasone are commonly     used drugs to treat relapsed or refractory acute lymphocytic leukemia or lymphoma (ALL). In     this study, the investigators want to know if adding three drugs called panobinostat,     bortezomib and liposomal vincristine (VSLI) to this regimen will result in remission (no     signs or symptoms of leukemia or lymphoma).        -  Panobinostat has been approved by the FDA for treating adults with multiple myeloma, but          it has not been approved for use in children and has not been given together with the          other drugs used in this study. It has not been widely studied in children.        -  VSLI has been approved by the FDA for adults with relapsed or refractory ALL, but has          not yet been approved for treating children with leukemia or lymphoma.        -  Bortezomib has been approved by the FDA for treating adults with a cancer called          multiple myeloma and adults with relapsed mantle cell lymphoma; it has not been approved          for treating children.      PRIMARY OBJECTIVE:        -  To estimate the complete remission (CR) rate for patients with T-cell lymphoblastic          leukemia and lymphoma in first relapse.      SECONDARY OBJECTIVES:        -  To evaluate minimal residual disease (MRD) levels at end of each block of therapy.        -  To describe the toxicities of vincristine sulfate liposome injection (VSLI) when used in          combination with chemotherapy and bortezomib.   "
58586|NCT02518737|"     The bone tissue of the human adult body is in a constant process of break-down (resorption)     and rebuilding (formation), a process called bone remodeling. The extent to which bone     remodeling happens varies during the day, especially a decrease in the bone resorption is     observed after eating.      The overall purpose of this study is to examine the possible role of the hormone     Glucose-dependent Insulinotropic Polypeptide (GIP) in Bone Remodeling. GIP is released from     cells in the gut after eating, and previous studies have shown an effect of GIP on bone     tissue. In addition, it has been observed that the risk of bone fracture is 60% higher in     women with a mutation in the GIP receptor, when compared to women with a normal functioning     GIP receptor.      In the present study humans with a mutation in their GIP receptor is compared to humans with     a normal functioning GIP receptor. The study population will be examined during a meal     stimulation test, where blood will be sampled regularly. The blood samples will be examined     for markers of bone resorption among other markers of bone remodeling, GIP and other gut     hormones.      The hypothesis for the present study is that GIP secreted after meal ingestion inhibits bone     resorption. Thus it is expected that the decrease in resorption is less pronounced in the     humans carrying the GIP-receptor mutation, compared to humans with a normal functioning GIP     receptor.   "
58587|NCT02518724|"     In order to examine the effect of RIPC on skeleton muscle exertional damage and on aerobic     and anaerobic physical performances, 30 healthy volunteers will undergo a series of different     physical tests twice; once without intervention and a second time with RIPC intervention or     placebo (false) intervention.   "
58588|NCT02518711|"     The goal of this study was to investigate the effectiveness of a behavioral teacher program     addressing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) in the classroom.   "
58589|NCT02518698|"     The goal of the study is to provide a detailed description of treatments for CRPC (Castrate     Resistant Prostate Cancer) patients with bone metastases and the resource utilization and     costs associated with that diagnosis and subsequent treatments.   "
58590|NCT02518685|"     The purpose of this clinical research trial is to study safety and effectiveness of the     TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered     medically obese.   "
58591|NCT02518672|"     Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would     increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific     metabolites involved in the resolution of inflammation.      The PREMDIC project, initiated at the Centre Hospitalier Universitaire de Sherbrooke, is a     randomized double-blind study for people with cystic fibrosis (CF) and aims to evaluate     whether daily supplementation monoglyceride of DHA (a fatty acid omega-3 family) will reduce     lung inflammation and improve pulmonary function.   "
58592|NCT02518659|"     Hypomagnesemia is a severe side effect of longterm use of all available proton-pump     inhibitors (PPIH). It develops due to intestinal malabsorption of Mg2+.      This study investigates the application of dietary inulin fibers in users of proton-pump     inhibitors with such a hypomagnesemia. To this end, repetitive short-term trials of 14 days     of orally administered inulin, separated by a wash-out period of 14 days each were performed     in cases of PPIH and controls. This study was not blinded or randomized.   "
58593|NCT02518646|"     Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the     early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet     implemented as standard in clinical practice, as it is unknown which delirium prediction     model can best be used to predict delirium in ICU patients.Therefore the main aim of this     study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.   "
58594|NCT02518633|"     Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of     cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea.     Reduced adipose tissue oxygen availability has been described in obesity and may also be a     mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose     tissue which are factors contributing to cardiovascular risk. The investigators hypothesize     that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by     comparing in vivo AT oxygenation and blood flow in tissue of control subjects.   "
58595|NCT02518620|"     The objective of this study is to evaluate the long-term efficacy and safety of ALX-0061     administered subcutaneously (s.c.) to subjects with active Rheumatoid Arthritis (RA).   "
58596|NCT02518607|"     This study is to assess the safety and tolerability aspects of oral MGB-BP-3, a treatment for     Clostridium difficile infections.   "
58597|NCT02518594|"     This protocol outlines a randomized trial of 630 women evaluating the use of micronized     vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in     women carrying twins and with a cervical length of less than 30 millimeters.   "
98619|NCT01995318|"     Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in emergency     department. It enhances Karlsson score more than elastic bandage.   "
58601|NCT02518542|"     Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as     dysphagia, regurgitation, chest pain and consecutive weight loss.      Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon     dilatation (BD) can provide sufficient symptom relief in many patients, both interventions     have their individual drawbacks. Additionally, treatment after failed LHM or BD can be     challenging and in few might even lead to esophagectomy.      Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel     endoscopically performed therapeutic options for achalasia and other esophageal motility     disorders. Both not only appear to provide good results, when performed as initial treatment     but also might be an excellent option after e.g failed LHM.      The purpose of this study is to evaluate the long-term efficacy of four different treatment     options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an     individualized treatment setting.   "
58602|NCT02518529|"     Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At     or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT     were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study     duration 52 weeks).   "
58603|NCT02518516|"     Statins are a class of cholesterol lowering medications that are prescribed for the     prevention and treatment of cardiovascular disease. The purpose of this study is to determine     if there is an excess risk of acute kidney injury (AKI) with high potency statins compared to     low potency statins.      The investigators will carry out separate population based cohort studies using     administrative health care databases in nine jurisdictions in Canada, the US, and the UK.     Cohorts will be defined by the initiation of a statin, with follow-up until hospitalization     for AKI. Analyses will be done separately for groups of patients with and without chronic     kidney disease. The results from the separate sites will be combined in a meta-analysis to     provide an overall assessment of the risk of AKI in new statin users.   "
58604|NCT02518503|"     Statins are a class of cholesterol lowering medications that are prescribed for the     prevention and treatment of cardiovascular disease. The purpose of this study is to determine     if there is an increased risk of new diabetes when exposed to high potency statins, compared     to low potency statins, among patients who had a recent cardiovascular event or procedure.      The investigators will carry out separate population based cohort studies using     administrative health care databases in eight jurisdictions in Canada, the US, and the UK.     The cohort will be defined by the initiation of a statin, with follow-up until a diagnosis of     incident diabetes or a prescription for insulin or an oral antidiabetic medication. The     results from the separate sites will be combined in a meta-analysis to provide an overall     assessment of the risk of new onset diabetes in subjects starting a statin.   "
58605|NCT02518477|"     This study will examine whether lymphedema after breast cancer surgery can be reduced. In a     randomised controlled design the aim is to investigate whether an early intervention with     progressive resistance training and close monitoring of arm swelling can reduce the incidence     of lymphedema after breast cancer surgery.   "
58606|NCT02518464|"     This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the     hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg     by mouth (PO) twice a day) reduces episodic and/or chronic migraine headache symptoms in     patients with right to left shunt. Headache frequency while on Brilinta/ticagrelor will be     compared with the documented baseline for each subject. If the Brilinta/ticagrelor therapy     was effective (> 50% reduction in monthly headache days), the subject could elect to continue     therapy for an additional two months (56 days), while continuing to complete daily headache     logs.   "
58607|NCT02518451|"     This was a randomized, single-blind, two-period, two sequence cross-over study under fasting     condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and     bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated     caplets.   "
58608|NCT02518438|"     This double-blind, randomized trial examined whether tramadol wound infiltration decreased     postoperative pain following cesarean delivery under general anesthesia or reduced the need     for analgesics in the immediate postoperative period. Patients in the tramadol group consumed     significantly less morphine at all time intervals than those in the control group. The     investigators suggest that the use of wound infiltration with tramadol may be a useful     technique in patients who undergo cesarean section under general anesthesia to reduce     postoperative pain, improve recovery, and facilitate early contact of mothers with their     babies.   "
58609|NCT02518425|"     In a retrospective analysis of already existing clinical assessment data from patients with     functional voice disorders the following aspects will be sampled, encoded and analysed:     Outcomes pre and post treatment of        1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i),        2. perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain          Scale (GRBAS Scale),        3. instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and          range of speaking pitch and intensity, max. intensity and mean pitch of calling voice,          singing voice: min./max. and range of pitch and intensity, maximum phonation time,          Dysphonia Severity Index (DSI).   "
58646|NCT02517944|"     Patients with familial hypercholesterolemia (FH) at high cardiovascular risk may suffer from     silent micro-infarctions (MI) before clinical coronary heart disease manifestations because     of the lifetime exposure to elevated serum LDL-cholesterol levels.      The study aims to demonstrate the higher prevalence of silent myocardial infarction in a     population of asymptomatic patients with familial hypercholesterolemia at high cardiovascular     risk in comparison to control patients using Cardiac Magnetic Resonance sequences of delayed     gadolinium enhancement.   "
58610|NCT02518412|"     The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as     a cognitive enhancer for patients with Alzheimer disease.      Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are     applied to the brain by using two electrodes. These electrodes are placed on the scalp. The     current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by     increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the     present study, participants will undergo six stimulations. The effect of all stimulations     swill be measured with neuropsychological testing before the first (pre) and after the sixth     tDCS stimulation (post).   "
58611|NCT02518399|"     The purpose of the study is to investigate whether long-term heat therapy (i.e. 8 weeks of     hot tub 4-5x per week) improves biomarkers of cardiovascular health in young, healthy,     able-bodied individuals. Although exercise is a potent means of improving cardiovascular     health, many patients are unable to exercise effectively, and thus there is high demand for     novel therapies to better manage cardiovascular risk in these patients. If successful, this     study will set the groundwork for heat therapy to be used as an alternative treatment in     patients who have limited exercise capabilities for the prevention of cardiovascular disease.   "
58612|NCT02518386|"     Acute self poisoning is a leading cause of suicide attempts and leads to frequent emergency     department visits. However, the exact epidemiology of acute self poisoning is not known. The     description of the clinical pathway and the characteristics of patients with acute self     poisoning could lead to an improvement in emergency care.      The Investigators will conduct a 48h observational study in emergency services in France.     Investigators primary objective is to gathered epidemiological clinical and treatment data     during emergency dispatch, prehospital care and inhospital emergency care.   "
58613|NCT02518373|"     This Phase 2 study was an open label, single-center 18-week study to compare basal and meal     stimulated plasma gastrin levels before and after treatment with 3 intramuscular injections     of 250 µg G17DT, with and without the concomitant administration of Omeprazole.   "
58614|NCT02518360|"     Determine the improvement in nonspecific low back pain patients with osteopathic techniques     (Body Adjustment Protocol) and know changes in stabilometric measures analyzed with a     stabilometric platform (Footscan®).   "
58615|NCT02518347|"     The proposed study aims to examine the hypothesis that strawberry supplementation will lower     serum biomarkers of inflammation and improve knee function in patients with symptomatic     osteoarthritis (OA).   "
58616|NCT02518334|"     Many studies have reported that alcoholic beverage consumption, especially in the form of     wine, reduces the risk of developing type 2 diabetes by as much as 40%. This association     suggests that wine consumption may somehow improve the body's ability to control its blood     glucose concentration. Indeed, it has been reported that when wine is consumed immediately     prior to ingestion of glucose, the release of insulin is enhanced and blood glucose     concentration is lowered. The mechanism of wine's effects on blood glucose concentration is     unknown, but is likely related to its ethanol or antioxidant content. In this study, the     investigators plan to test whether wine or plain ethanol (vodka) ingestion alters the control     of blood glucose in subjects who have diabetes or pre-diabetes.   "
58617|NCT02518321|"     Toileting is a private activity of daily living. Geriatric rehabilitation patients are often     unable to toilet themselves independently, leading to embarrassment and loss of self-esteem.     Relationships with their caregivers may also become strained. Furthermore, improper toileting     hygiene can lead to skin irritation, breakdown and infection.      Technology-assisted toilets (TATs) clean and dry the anal and vaginal regions using a stream     of water and a fan. They can therefore potentially eliminate the need for patients to be able     to wipe themselves. TATs are operated using wall-mounted remote controls. This study will     examine the potential benefits of TAT use in geriatric rehabilitation patients.      Forty patients aged ≥65 years referred for treatment of physical impairments to the Geriatric     Rehabilitation Unit (GRU) of the Elisabeth Bruyère Hospital (EBH) will be recruited for this     study. Participants will have a bowel movement on two occasions, once using toilet paper and     once using the TAT. The Psychosocial Impact of Assistive Devices Scale (PIADS), a validated     questionnaire, will be used to analyze participants' toileting experience. Participants will     be visually evaluated for cleanliness before and after each testing session.      The investigators hypothesize that participants will report that, in comparison with use of a     standard toilet, toileting using the TAT: 1) is easier to use, 2) improves psychological     well-being and 3) is more effective at cleaning than regular wiping techniques.   "
58618|NCT02518308|"     This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR)     intervention works in reducing anxiety in patients who have undergone treatment for     gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of     the female reproductive tract, which includes the cervix, endometrium, fallopian tubes,     ovaries, uterus, and vagina. Side effects from treatment for these cancers may include     anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses     meditation and yoga to help patients focus on breathing, bodily sensations, and mental     awareness. This may help decrease patients' stress and anxiety and improve their quality of     life, and may also help their immune system.   "
58619|NCT02518295|"     The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains     help improve lactose digestion in subjects with lactose maldigestion.   "
58620|NCT02518282|"     A measurable degree of heart muscle tissue injury is expected in patients undergoing heart     valvular surgery. The level of this injury can be measured by cardiac biomarkers in blood     samples. Those biomarkers are used to diagnose an acute myocardial infarction.      Postoperative myocardial infarction (MI) is a frequent and important complication after     cardiac surgery with high morbidity and mortality. Therefore it is very important to     recognize any cardiac event in patients who undergo cardiac surgery. Different diagnostic     tools can be used to the diagnosis of acute myocardial infarction; however few is known about     the value of high-sensitivity cardiac troponin T (hs-cTn) to diagnose a MI after heart     valvular surgery.      The aim of this study is to determine the upper reference limit of high-sensitivity troponin     T concentration to consider the diagnosis of acute myocardial infarction in patients     undergoing heart valvular surgery.   "
59064|NCT02512432|"     To join established study put on by Addition Technologies, Inc. in the surgical implantation     of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.   "
58650|NCT02517892|"     This is a prospective study to identify molecular mechanisms of acquired resistance to     targeted therapies in patients with unresectable or metastatic cancer.      This is a protocol to study clinical characteristics and biopsy tissue of patients with     oncogene-driven cancer who have had previous clinical response to targeted therapy and     subsequently experience progression of disease. The tissues and other specimens will be used     to carry out laboratory studies to explore the molecular basis of acquired resistance to     targeted therapies.   "
99311|NCT01986218|"     The primary purpose of this study is to evaluate the safety and effectiveness of daily doses     of BMS-986115 in subjects with advanced solid tumors   "
58622|NCT02518256|"     The ovarian surface, the Fallopian tubes, the uterine cavity and the peritoneal cavity all     together form a communicating compartment. The physiologic function of the ciliated lining of     the tubes is to transport the egg, after ovulation, into the uterine cavity. Thus, making it     very likely that exfoliated cells from pathologic changes of the ovarian surface and     Fallopian tube lining will be present in a lavage from the uterine cavity.      The proof of concept that malignant cells from the upper genital tract get transported even     into the lower genital tract was recently published by Kind I. et al. Liquid-based cervical     cytology allows not only cytological evaluation but also collection of DNA. A panel of genes     that are commonly mutated in endometrial and ovarian cancers was assembled with new     whole-exome sequencing data from 22 endometrial cancers and previously published data on     other tumour types, including mutations in the TP53 gene. This panel was used to search for     mutations in 24 endometrial and 22 ovarian cancers and identified mutations in all 46     samples. With a sensitive massively parallel sequencing method, it was possible to identify     the same mutations in the DNA from liquid Pap smear specimens in 100% of endometrial cancers     (24 of 24) and in 41% of ovarian cancers (9 of 22).      In the current project the investigators will study the specificity and sensitivity of the     lavage of uterine cavity and proximal tubes as a test to differentiate between malign and     benign ovarian tumours. The investigators aim to detect cells from EOCs or genetic material     from those cells in the lavage.   "
58623|NCT02518243|"     All over the world the increasing prevalence of chronic disorders and its impact on     functional decline is challenging the sustainability of health care systems. Older     individuals also frequently experience the reversible frailty syndrome, which overlaps with     chronic diseases, increasing incidence of disability.      Building a global system aiming to take in charge all causes leading to loss of autonomy is a     rather complicated task involving numerous Information and Communication technologies (ICT)     solutions which are not always easy to use in everyday life.      The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality     of life of older people at risk.      The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation     aromatherapy automatic fragrance ...) .      The goal of this study is to validate the acceptability, sensitivity and efficacy of the     systems.   "
58624|NCT02518230|"     This study is a single center, prospective cohort crossover study comparing mechanically     ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and     synchronized intermittent mandatory ventilation with pressure control plus pressure support     (SIMV(PC) + PS) modes.      This design will allow for direct comparison of two commonly used ventilator modalities in     the neonatal intensive care unit (NICU) to determine if one mode is superior to the other     with regards to respiratory mechanics and estimated energy expenditure.      It is hypothesized that neonates and infants will have improved respiratory severity score     (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased     estimated energy expenditure.   "
58625|NCT02518217|"     This randomized controlled trial will evaluate patterns of use and health outcomes of the     ShapeUp Empower online program with and without financial incentives for program engagement.   "
58626|NCT02518204|"     The purpose of this study is to evaluate the concurrent validity between the Brain     Performance Test (BPT) subtests and corresponding conventional in-person neuropsychological     assessments (NP).   "
58627|NCT02518191|"     This prospective randomized controlled study is conducted to analyze the effect of Goserelin     on ovarian function in women with breast cancer in China.   "
58628|NCT02518178|"     This is a three arm cluster randomized controlled trial where the unit of randomization is     the immunization camp. Immunization camps are the sole provider of vaccinations in our study     area and have catchment areas of several villages. The 96 immunization camps will be     randomized evenly to one of three arms:        1. control arm; where near field communication (NFC) stickers will be placed on existing          immunization booklets. These stickers can be scanned using a mobile phone with an          installed application whereby information can be entered onto the phone and then scanned          onto the sticker        2. pendant only; where the same NFC technology will be placed into a pendant that is worn          by the infant, and        3. pendant as described above with voice reminders sent 15 days, 1 day prior, and the day          of the scheduled immunization camp dates.   "
58629|NCT02518165|"     This study was designed to evaluate the chronic effects of a proprietary spearmint extract     over 90 days of supplementation on aspects of cognitive performance (cognitive function and     active reaction time), subjective mood, and sleep quality in healthy men and women.   "
58630|NCT02518152|"     The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF)     and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects     in chronic periodontitis patients.   "
58631|NCT02518139|"     The purpose of this study is to measure the safety and tolerability of TD 4208, an     investigational drug being developed to treat people with moderate to very severe COPD,     compared to tiotropium.   "
58632|NCT02518126|"     To see if there is a relationship between the level of LIF in IUGR fetuses and compared to     the level of LIF in AGA fetuses   "
58633|NCT02518113|"     The main purpose of this study is to evaluate the safety of the study drug known as LY3039478     in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or     T-cell lymphoblastic lymphoma (T-ALL/T-LBL).   "
58634|NCT02518100|"     This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and     monitor specified vital signs. It will be used in parallel with the normal equipment the     study site uses to take and monitor vital signs.   "
58644|NCT02517970|"     The objective of the proposed research is to conduct a within-subject experimental study that     will assess the effect of environmental distractions on a mothers' ability to recognize and     feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend     significantly more time looking at their technology compared to looking at their infant,     which will be negatively associated with the mothers' responsiveness to her infant. This will     have a positive association with infant intake during the feeding. Investigators also     hypothesize that mothers will show less sensitivity when distracted when compared to when     they are not distracted.   "
63456|NCT02455037|"     Evaluation of a neck strengthening program as a potential intervention to reduce the risk of     sport-related concussion in youth contact and collision sport athletes.   "
58635|NCT02518087|"     Our project intends to reduce acute kidney injury in non emergent cardiac surgery (AKI-CS)     patients with the use of an increased adsorption membrane (OXIRIS®) connected to the     cardiopulmonary bypass (CPB) circuit, besides evaluating the inflammatory response by     quantifying inflammatory mediators during and after cardiac surgery with CPB. Our study is a     randomized and controlled multicentre trial that includes recruiting centres with a long     experience in cardiac surgery with CPB.      The primary endpoint of the project is to evaluate the ability of OXIRIS® to reduce the     incidence of AKI-CS in patients undergoing non emergent cardiac surgery with CPB. With the     goal of reducing by 10% (from 15 to 5%) the risk of AKI-CS during the first postoperative     week a sample size of 340 patients has been calculated.      Secondary endpoints are two; first, to evaluate the effect of using OXIRIS® on survival,     clinical course and removal capacity of cytokines and lipopolysaccharide (LPS) during and     after CPB; and second, to assess the predictive value for AKI-CS of some new biomarkers, such     as uNAD (urinary nicotinamide adenine dinucleotide).   "
58636|NCT02518074|"     The investigators objective is twofold. Investigators propose to study how the vestibular and     auditory information interact in the construction of coherence between the staff and     extrapersonal space.      Furthermore, investigators want to investigate whether, even in the absence of gravity, the     auditory spatial information allocentric provide a framework for spatial reference.   "
58637|NCT02518061|"     This is a retrospective study that involves the revision of clinical, instrumental and     pathologic data of an estimated cohort of maximum 145 patients with glioma treated with     surgery with radical intent at our center.   "
58638|NCT02518048|"     The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam     compared with Betesil® medicated plaster   "
58639|NCT02518035|"     Effort to reduce post-surgical scar is especially important for microtia patients. Even the     scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear     auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will     accompanies the child for many years.The main objective aim of this study is to examine     whether post-operative use of silicone gel can improve scar formation for microtia     reconstruction scars.   "
58640|NCT02518022|"     The purpose of this study is to show that during and after drinking beer a treatment strategy     by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an     increase of hypoglycaemic events compared to a treatment strategy according to the standard     recommendation without insulin Bolus.   "
58641|NCT02518009|"     Gender dysphoria (DSM-5) or transsexualism (ICD10) is a condition in which a person's feeling     of gender identity is not congruent with the physical body. The hormonal treatment includes     inhibition of one's own sex hormone production followed by treatment with testosterone or     estrogen levels that are normal for the opposite sex. Seen as experimental model, this is a     process that provides an opportunity to study the sex hormone dependent influences that     explain differences in morbidity in men and women respectively. The differences that are     especially significant but not well known is 1) metabolic changes in the regulation of     glucose homeostasis and lipid metabolism 2) regulation of vascular function and structural     effects on the heart and arteries 3) regulation of skeletal muscle mass and fat tissue 4)     morphological and functional effects on discrete areas of the brain.      Therefore, the investigators will follow these patients for a year to study how the heart,     blood vessels, brain, and risk factors for cardiovascular disease affected by altered sex     hormone patterns and studying what happens in the muscles and fat in both the short and long     term with respect to particular gene expression and epigenetic changes and link it to     metabolic changes and body composition.   "
58642|NCT02517996|"     Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition     that severely impacts between 2.7 and 6.5 percent of women in the United States. Despite its     public health importance the pathogenesis of IC/PBS is not well understood and there is no     consensus on the optimal treatment approach for this condition. Hydrodistention is the most     commonly used therapy for this condition; but it is limited by severe immediate postoperative     bladder pain and its short duration of action. It has been postulated that hydrodistention     works by disrupting the sensory nerves within the bladder that may be contributing to bladder     pain. Recent evidence has provided support for the use of preemptive pudendal nerve block as     a way to blunt immediate postoperative pain. The investigators hypothesize that preemptive     pudendal nerve block prior to hydrodistention will result in lower postoperative pain after     hydrodistention compared to placebo. This is a prospective double- blinded randomized study     and patients will be randomized to receive preemptive bilateral pudendal nerve block with     either 1% lidocaine or placebo. Bladder pain will be compared at baseline, 2 hours, 2 weeks,     6 weeks and 3 months using the Visual Analog Scale, O'Leary-Sant questionnaire and the Pelvic     Pain Urgency and Frequency questionnaire.   "
58643|NCT02517983|"     World Health Organization (WHO) considers chronic respiratory disease (CRD) as one of its     four priorities. These diseases include asthma and rhinitis, chronic obstructive pulmonary     diseases (COPD), occupational lung diseases, sleep apnoea syndromes, pulmonary hypertension,     bronchiectasis and interstitial lung diseases. They constitute a serious public health     problem in all countries throughout the world, in particular in low and middle income     countries and in deprived populations. Hundreds of millions of people of all ages, in all     countries of the world, are affected by chronic respiratory diseases. More than 50% of them     live in low and middle income countries. Over 90% of deaths and the complete inability, due     to CRDs occur in countries with low or middle incomes.      The main causes of CRD are: tobacco smoke, occupational factors, indoor air pollution and     outdoor air pollution, allergens, sequelae of respiratory infections such as tuberculosis.      More than 30% of the population of Ho Chi Minh City (HCMC) could develop a CRD. In fact, 15%     of children and 7% of adults could become asthma and 6% of the population could become COPD     due to smoking. Children exposed to fumes from biomass burning, early in their life, seem to     have a higher risk to develop COPD. The high level of air pollution in HCMC could aggravate     asthma / COPD. Populations combining the rural risk (exposure to smoke from biomass) and the     urban risk (smoking, pollution) may develop COPD much earlier (before age 40). Among the 9     million people in HCMC, 50% of the population is rural origin. Within this population,     parasites could play a protective role against the risk of allergic asthma and consequently,     the better control of helminthiasis among urban population, may result in allergic diseases     such as asthma and anaphylaxis. Finally, the sequelae of tuberculosis (incidence is     200/100000) could participate to the morbidity of COPD / CRD.      Study granted by the ARES-CUD (Comission universitaire au développement)   "
58647|NCT02517931|"     This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural     puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive     a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo     nerve block.   "
100163|NCT01975090|"     The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide     temporary protection against pulmonary embolism (PE).   "
58655|NCT02517827|"     The endovascular therapy prevailed in nearly all regions of peripheral artery disease over     open surgery techniques. However, in treatment of the common femoral artery vascular surgery     is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today,     only in selected cases an endovascular procedure for common femoral artery diseases is     recommended.      The primary objective of this study is to compare the performance of directional atherectomy     and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in     a prospective, multi-center, randomized clinical trial.   "
58656|NCT02517814|"     Vitamin D deficiency could be a high risk for cardiovascular diseases. It has been recently     reported that vitamin D deficiency is another cause of heart failure and cardiomyopathies. It     was found that vitamin D supplementation improved the heart function. The purpose of this     study is to evaluate patients with idiopathic cardiomyopathies and determine whether vitamin     D supplementation in cases where there is a deficiency, improves heart functioning.   "
58657|NCT02517801|"     Anthocyanins are the most common polyphenols in berries and red wine, along with other     flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized     and they are transformed into glucuronides and phenolic acids. The investigators have     recently shown that the acute consumption of blueberries leads to an increase in     endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male     volunteers. There were significant correlations of these effects with the plasma     concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study     aims at understanding to which extent the anthocyanins contained in berries are related with     positive effects in endothelial function. A large part of the absorbed anthocyanin circulate     in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. The     formation of these metabolites begins right as early as 2h after consumption due to     metabolism at the small intestine and a second plasmatic peak occurs around 6h due the     metabolism of colonic bacteria. Whether and which metabolites are associated with biological     effects and the mechanisms underlying this effect remains unclear.   "
58658|NCT02517788|"     Phase I study aiming at:        -  establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration          of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in          pre-filled syringes) at 18 MIU;        -  investigating the possible impact of albumin on pharmacokinetic profile by comparing 3          different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution          in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif®          from Merck-Serono, a registered IFN beta-1a solution containing HSA;        -  establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in          HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals          against Rebif® using the same regimen.   "
58659|NCT02517775|"     Accumulating evidence from epidemiological and human intervention studies indicates that the     cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related     to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular     anthocyanins, but also phenolic acids. At present, a small number of randomized controlled     trials investigating the effects of berry (poly)phenols on validated surrogate markers of     cardiovascular disease risk has shown promising results. However, to date, very few human     studies have specifically investigated the effects of cranberry (poly)phenols on     cardiovascular function in healthy subjects. To our knowledge, no study has investigated the     time and intake-dependent effect of cranberry consumption on vascular function in healthy     subjects. This information is necessary for the planning of long-term studies aiming to     assess the potential beneficial effects of cranberries, using optimal amounts at optimal time     points. Therefore, this study aims to investigate the potential role of cranberry     (poly)phenols in the modulation of vascular function by monitoring changes in vascular     function together with the major (poly)phenol derivatives/metabolites in plasma and urine.   "
58660|NCT02517762|"     The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the     cause of pain, evaluation of treatments and development. Employees from a large local     manufacturing company are sent for a complete orthopedic and pain evaluation immediately     after onset of acute low back pain. Thereafter, the included patients are allocated either to     the advice to stay as active as possible in spite of the pain or to adjust their activity to     the pain. Pain intensity and physical activity are followed prospectively over seven days     using a diary and a pedometer.   "
59122|NCT02511678|"     This study will evaluate the efficacy of cryoablation for palliation of painful metastases in     patients with metastatic lesions involving bone who have failed, are not candidates for, or     are not experiencing adequate pain relief from current pain therapies (e.g. radiation,     analgesics).   "
58661|NCT02517749|"     This is a multicentre randomised controlled trial evaluating global health related quality of     life outcomes in patients with malignant pleural effusions. Patients will be randomised to     receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc     pleurodesis. Patients will be followed up for 3 months post intervention   "
58662|NCT02517736|"     The objective of the study is to determine the efficacy and toxicity of sorafenib in     metastatic uveal melanoma.      The main objective is to determine the non-tumor progression rate 24 weeks after initiation     of treatment with sorafenib at a dose of 800 mg / day   "
58663|NCT02517723|"     Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for     survivors of prolonged and repeated exposure to traumatic stress and childhood adversity.     Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid     Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims     are the reduction of PTSD-Symptoms in these patients via activation of associative neural     networks related to traumatic experiences and habituation of fear and the placement of     traumatic experiences in a reconstructed, detailed and consistent autobiography. This     practice enables the processing of and coping with painful memories and the construction of     clear contingencies of dangerous and safe conditions, generally leading to significant     emotional recovery. The investigators assume that using NET the reduction of PTSD symptom     severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).   "
58664|NCT02517710|"     Prospective single blinded trial comparing standard synthetic suture material to a synthetic     barbed suture in closure of uterine incision, during Cesarean section procedures.   "
58665|NCT02517697|"     The objective of the study is to investigate effects of inorganic sodium nitrite on the     cardiometabolic and hormonal disturbances observed in a targeted population of     overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin     resistance and endothelial dysfunction.   "
58666|NCT02517684|"     The purpose of this study is to determine whether a top-down treatment approach, prescribing     infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to     the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral     nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.   "
58667|NCT02517671|"     The purpose of this study is to assess the effects of 35 EECP sessions on cardiopulmonary     training performance in healthy volunteers. Data from this study will be used to generate     sample size and power calculations for feasibility of future EECP studies. The results of     this study could provide evidence that can help active duty and Department of Defense     beneficiaries optimize physical conditioning, endurance and overall health.   "
58668|NCT02517658|"     The study will involve parents filling out a survey before & after watching a teaching tool     video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching.     The parents randomized to the video arms will watch the video while their child is in the OR     and then either take the post survey immediately after or wait to take the survey until just     prior to discharge. Parents not in the video arms of the study will also be asked to complete     a survey pre and post standard pain management teaching.   "
58669|NCT02517632|"     The aim of this investigation is to evaluate the impact of exercise in a cardiac     rehabilitation program on functional capacity, clinical markers, quality of life and     biomarkers in patients with chronic chagasic cardiomyopathy.   "
58670|NCT02517619|"     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with     dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery     System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with     non-infectious anterior segment uveitis.   "
58671|NCT02517606|"     Chronic nonspecific low back pain is an important health condition with a high prevalence     worldwide and it is associated with enormous direct and indirect costs to the society.     Clinical practice guidelines show that many interventions are available to treat patients     with chronic low back pain, but the vast majority of these interventions have a modest effect     in reducing pain and disability. A biomechanical approach that has been raised is that a     weakness of the hip abductors, extensors, and lateral rotators musculature (posterolateral     complex - PLC) would lead to excessive contralateral pelvic drop during weight-bearing     activities such as walking, running, climbing up or downstairs, generating an overload in the     lumbar area. Although the strengthening of the hip PLC is largely used in clinical practice     for treating patients with hip and knee injuries, there is still a lack of evidence regarding     patients with low back pain. Therefore, questions remain about the efficacy of the hip     dynamic stabilization as an additional intervention to conventional treatment in a well     design trial with statistic power.   "
58672|NCT02517593|"     The primary aim of this study is to determine if the addition of an individual polygenic risk     score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk     Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer     in making a decision to take (or not take) medications to prevent breast cancer   "
58673|NCT02517580|"     This study is a single arm, single center clinical trial that aims to evaluate the effect of     8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in     stable renal transplant patients.   "
58674|NCT02517567|"     The purpose of this study is to evaluate the tear film evaporation of symptomatic soft     contact lens wearers in the absence of contact lens wear and after at least 8 hours of     contact lens wear.   "
58675|NCT02517554|"     The goal of this research is to evaluate the relative advantage of remote counseling over     usual care in community health practices without access to genetic services. We will evaluate     ability of remote telemedicine, referred to going forward as TeleGenetic services (phone or     videoconferencing), to increase uptake of genetic testing and identification of genetic     carriers compared to usual care. Secondly, we will evaluate the advantages of     videoconferencing over telephone for delivery of remote genetic services and the short-term     and longitudinal outcomes of TeleGenetic services in socio-demographically diverse patients     in community practices.   "
58676|NCT02517541|"     The aim of the study is to obtain an understanding of relevant parameters affecting the     performance of ostomy products.   "
59123|NCT02511665|"     This is a randomized, placebo-controlled, double-blind, window of opportunity study     investigating the biological mechanism of metformin in prostate cancer.   "
58677|NCT02517528|"     This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT     450/r/ ABT 267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks in HCV genotype     1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV     treatment-experienced Asian adults with compensated cirrhosis.   "
58678|NCT02517515|"     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating     ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced adults with     subgenotype 1b chronic HCV.   "
58679|NCT02517502|"     The purpose of this study is to determine if a high dose of DHA begun prior to and continued     during neo-adjuvant chemotherapy (chemotherapy given prior to surgery) is likely to prevent     or lessen chemotherapy induced cognitive dysfunction.   "
58691|NCT02517346|"     The purpose of this study is to compare the effectiveness of telemonitoring versus standard     follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).   "
58713|NCT02517047|"     Background: Pediatric asthma is the most common chronic illness among children and is     associated with poor quality of life, activity restriction, school absences, and thousands of     physician visits annually. The purpose of this study is to measure the effectiveness of using     an innovative tracking system (CareTRx) for the self-management of asthma, including daily     and rescue medication use, among children and adolescents with pediatric asthma.   "
61059|NCT02486354|"     This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the     efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after     failure of at least one platinum-based chemotherapy regimen.   "
58680|NCT02517489|"     Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is     between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate     pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of     inflammation-associated systemic complications. Two recent meta-analyses suggest a positive     effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are     based on only four trials gathering less than 300 patients, of which only one was positive.     Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a     well-powered trial appears necessary to test the hypothesis that CTx - and more specifically     hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP,     severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the     use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.      A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing     the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to     antibiotics and supportive care, including the correction of hypoxemia.      Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the     time of inclusion.   "
58681|NCT02517476|"     The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of     early nutritional therapy in regard to effectiveness, safety and costs when applied to the     heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the     question about overall benefit or harm, but using a physio-pathological mechanistic approach,     it also will explore and provide conclusive answers about whether, why, how, and in which     patient populations nutritional therapy does and does not works.   "
58682|NCT02517463|"     This was a prospective, open-label, single-drug, uncontrolled, observational clinical study.      Women attending the Family Planning Association of Hong Kong (FPAHK) for emergency     contraception within 120 hours of UPSI were recruited. Subjects were recruited from both the     Birth Control Clinics and Youth Health Care Centres of the FPAHK.      Depending on the timing in relation to ovulation in the current menstrual cycle at the time     of presentation, the women were classified into two groups:      Group 1: pre-ovulatory Group 2: post-ovulatory      After counseling and obtaining informed consent, eligible subjects received a single dose of     ulipristal acetate 30 mg (ellaOne®) under direct supervision. A baseline blood test for     hormonal profile (LH, oestradiol and progesterone) and ultrasound scan for ovarian follicle     assessment were carried out by a designated doctor or research nurse at the clinic visit.      The subjects were advised not to have further acts of coitus before the return of     menstruation. They were given a diary chart to record vaginal spotting and bleeding, possible     side effects and further acts of intercourse, if any, and the contraceptive method used. A     follow-up appointment were be arranged about 1-2 weeks after the expected next menstruation.     Any events of unplanned pregnancy and adverse effects were recorded for analysis.   "
58683|NCT02517450|"     This study tested the effectiveness of an adventure-based training programme in promoting the     psychological well-being of primary schoolchildren. A randomised controlled trial was     conducted, with 56 primary school pupils randomly assigned to the experimental group     participating in the adventure-based training programme and 64 to the attention placebo     control group.   "
58684|NCT02517437|"     The purpose of this study is to determine whether the combination of suprascapular and     axillary nerve blocks is non-inferior to the conventional interscalene block (ISB) in     providing pain relief during the first postoperative day to adult healthy patients (age > 18)     undergoing ambulatory shoulder surgery.   "
58685|NCT02517424|"     The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in     participants with chronic, treatment-resistant posttraumatic stress disorder.   "
58686|NCT02517411|"     Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by     incompletely reversible airflow obstruction. It is projected to be the fifth leading burden     of disease worldwide by the year 2020. Pulmonary dysfunction reduces exercise capacity in     COPD patients, and it has been previously shown that COPD patients suffer deterioration in     their quality of life. The objective of this study is to examine the effects of a physical     therapy intervention in stable patients with COPD.   "
58687|NCT02517398|"     The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose     levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means     the study drug has not previously been given to humans or has only been given to a limited     number of people, although it has been extensively studied in animals. Based on this     information, it is hoped to find out which dose could be best for the treatment of patients.     There are two parts of this research study: a dose-escalation part and an expansion part.     Dose escalation means that the first people taking part in the study will receive low doses     of the study drug, and as more people take part, the additional participants will receive a     higher dose. This is done to find the safest dose for the study drug. Expansion means that     after the dose-escalation part of the study has looked at the safety and effectiveness of     different doses, many more people will be invited to take part in the study and will receive     the study drug at the safest dose. Additional purposes of the study are to find out whether     the study drug has anti-cancer effects and how the study drug is processed by the body.   "
58688|NCT02517385|"     Primary Objective:      To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day     for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.      Secondary Objectives:      To assess effectiveness on symptomatic improvement in patients with gastrointestinal symptoms     in acute and chronic liver diseases.      To monitor compliance.   "
58689|NCT02517372|"     This study is a single-centre, open-label, dose escalation , safety, tolerability and     pharmacokinetics (PK) study in healthy male and female subjects. The study include a     screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and     each cohort will include 8 subjects. there will be 24 subjects total included in the study.     The duration of the clinical part of the study will be approximately 2 months.   "
58690|NCT02517359|"     RV6153 is a new medicine being developed for possible treatment of asthma and smoking related     lung disease (also known as chronic obstructive pulmonary disease - COPD).      The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics     and pharmacodynamics of single and repeat doses of RV6153   "
58692|NCT02517333|"     The importance of play and physical activity include its many benefits on positively     improving health and well-being, enhancing children's and young people's thinking and     performance in school, improving their sleep and enabling confidence and skill building     (Janssen and LeBlanc, 2010; Budde et al., 2008; Sallis and Patrick, 1994). However, children     with movement difficulties (MD) and physical disabilities are at risk of decreased physical     activity and subsequently decreased physical fitness and overall health and well-being as a     result. To build upon current findings and to follow-up on a continuing study, looking at the     impact (responses) and recovery during and following acute exercise at different intensities     in children and adolescents with and without movement difficulties, this next phase aims to     provide an intervention to improve fitness levels and health measures and to strategically     provide a pathway for longer term participation in physical activity in young people.     Implement and evaluate a pathway to sport for 14+ year old young people who do not regularly     participate in sport due to Neurodevelopmental conditions, young people presenting with poor     coordination and movement, and even children and adolescents with special educational needs.     The pathway hopes to promote engagement, participation, inclusion and confidence (EPIC) in     sport within local schools and the community through 1) targeted recruitment, 2) confidence     and skill building (EPIC Club), 3) connection to sport ('Have a go days') and 4) exit to long     term participation.   "
58693|NCT02517320|"     The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic     nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the     first morning void urine sample as an indicator.   "
58694|NCT02517307|"     The purpose of this study is to learn more about what causes insulin resistance. It has been     suggested that proper breakdown of fat into energy (oxidation) in the body is important to     allow insulin to keep blood sugar in the normal range. The investigators want to know if     having one of the fatty acid oxidation disorders could have an influence on insulin action.     Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that     converts fat into energy. The investigators will study both normal healthy people and people     with a long-chain fatty acid oxidation disorder.   "
58695|NCT02517294|"     Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal     tube during nasotracheal intubation in children undergoing general anesthesia for dental     surgery.   "
58696|NCT02517281|"     The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in     patients treated using targeted therapies in order to have a better understanding of the skin     pathophysiology.   "
58697|NCT02517268|"     This randomized clinical trial studies accelerated recovery pathway for discharge after     surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may     improve outcomes after surgery following complex abdominal operations resulting in a shorter     length of stay in patients with pancreatic cancer. It may also help patients to mobilize more     quickly and return to the home setting, decrease hospital-acquired infectious complications,     and increase potential cost savings. It is not yet known whether an accelerated recovery     pathway is better than a standard recovery pathway for discharge following surgery in     patients with pancreatic cancer.   "
58698|NCT02517255|"     Atherosclerotic disease is responsible for one third of all deaths annually and is a major     cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads     to complications such as acute myocardial infarction with ST-segment elevation. Rescue     angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing     mortality and the amount of myocardium effectively saved are not well established. The     development of new tools, including cardiac magnetic resonance imaging to identify myocardial     area at risk and infarcted increased diagnostic accuracy. However, unlike the context of     primary angioplasty, little is known about the relation between coronary epicardial and     microvascular flow after rescue angioplasty and myocardial salvage. The objective of this     study is to evaluate whether there is a relation between these flows and myocardial salvage     identified by Magnetic Resonance Imaging (MRI). At the end of this research, the     investigators hope to contribute to a better understanding of coronary flow and its relation     to the amount of heart muscle saved after rescue angioplasty. This is an important     information that can help understand which cases benefit most from rescue angioplasty.   "
58699|NCT02517242|"     This is a prospective, intervention, randomized, phase IV study. Patients will be included     with 60 years or older, both sexes, with HbA1c >8.5% using oral antidiabetics agents and     insulin and then we will be randomized by use syringe or pens device to use insulin NPH and     regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood     glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients     will see monthly.   "
58700|NCT02517229|"     The scientific goal of this experiment is to evaluate changes in balance control in response     to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular     parameters under microgravity are compared to normal gravity conditions. To induce postural     responses among the test subjects, an electromagnetic maneuverable postural platform will be     used in order to randomly elicit perturbations. Postural reactions will be quantified by     means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation     will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex     measurements were chosen as they allow reliable information about inhibitory and facilitatory     mechanisms taking place at the spinal level.   "
58711|NCT02517073|"     The mechanical ventilation strategy has changed over years worldwide. Several international     researches have been conducted to study the association of the use of mechanical ventilation     with clinical outcomes. In this prospective, multicenter, cross-sectional survey, the     practice of mechanical ventilation among patients with severe brain injury will be     investigated in 70 intensive care units in China.   "
58712|NCT02517060|"     The investigators measure brain responses of healthy participants while they perform     evaluation tasks inside the fMRI. For each task the participants were primed with tactile     stimuli. Results should demonstrate engagement of sensorimotor brain regions after priming,     hence confirming embodiment theories.   "
58729|NCT02516839|"     The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL     compared to an active comparator (AC) and to BWL.   "
58701|NCT02517216|"     Weightlessness profoundly modifies many physiological systems and especially the nervous     system and the vestibular system. The changes in the nervous system are based in part on     brain plasticity mechanisms, that is to say on modifications of neurons and their     connections. They are the source of some of the behavioral response observed in the parabolic     flight or in astronauts. For example, it is commonly observed that in the second and third     days of parabolic flight campaigns with 3 flights, fewer participants are prone to motion     sickness during the first day. Similarly, during their first trip into space, astronauts     suffer 2/3 for 2 or 3 days of space sickness - special form of motion sickness - while this     proportion is much lower in the second trip.      The hypothesis of this study is that short-term weightlessness as well as changes in the     level of gravity experienced during parabolic flights, induce neuroplascity phenomena in     brain regions involved in the integration of vestibular, visual and proprioceptive.      The goal is to objectify these plasticity phenomena, and assess their changes over time,     using methods of Magnetic Resonance Imaging (MRI). A standard MRI will give an anatomical     image of the brain. For this study, a variant called diffusion MRI (Diffusion Tensor Imaging     - DTI) will visualize nerve bundles and their journey in the brain. The total duration of     this review will be about ¾ hour.      The results of this study will be compared with those of an ongoing study of 12 astronauts     who have the same MRI scans taken before and after a trip to the International Space Station.     Investigators can then evaluate the effect of duration of exposure to weightlessness on the     phenomena of neuroplasticity.   "
58702|NCT02517190|"     From previous parabolic flight campaigns completed by our research group investigators     gathered data showing important changes in neuro‐endocrine and also immunological changes.     This experiment now will complete the data set‐up obtained during the MARS500 study on how     these respective individuals will re‐act to highly physically and emotionally challenging     situations during a parabolic flight.      This add‐on experiment to MARS500 will enable answering to the following questions i) if the     stress response systems - when compared for two conditions but in the same individuals - do     react uniformly and ii) if those subjects prone to have adequate stress response pattern will     show gradually less immune modulation effects.      The understanding of the complex interactions of stress and immunity under chronic and acute     stress conditions might help to enable adequate health and immune monitoring and might as     well suggest suitable countermeasures for the prevention of the unwanted immunological     effects during long‐term confinement and space missions.   "
58703|NCT02517177|"     As a direct consequence of exposure to microgravity, astronauts experience a number of     physiological changes which can lead to serious medical implications. Most immediate and     significant is the headward shift of body fluids and the removal of gravitational loading     from bone and muscles, resulting in progressive changes of the cardiovascular and     musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has     been demonstrated in studies of short term (shuttle) and long term missions to Skylab and     MIR.      Our main hypothesis is that there is a linear relationship between the gravity level (0G,     0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate     variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral     analysis of HRV and BPV.   "
58704|NCT02517164|"     Every year, nearly 30% of people aged over 65 fall at least once and about 15% fall at least     twice. These falls can have serious consequences that are a significant threat to the     independence and well-being of older people. From an economic perspective, the cost of     medical care related to falls and resulting injuries is very high and continue to grow with     the aging of the population. Therefore falls prevention is a public health priority.      Many data suggest that cognitive, common disorders in the elderly, is a major risk factor for     falls and the elderly often have difficulty managing their parallel postural stability and     other situations requiring attentional resources. Furthermore, the data used to evoke a role     of vitamin D in the risk of falls in the elderly. Indeed, vitamin D has beneficial effects on     muscle and on the human brain and several recent studies have shown the existence of positive     relationship between serum 25 hydroxyvitamin D and cognitive function. These different     actions may explain the beneficial effect of vitamin D supplementation on the risk of falling     for practicing daily oral doses of vitamin D in the range of 700-1000 IU.      Our goal in this study is to confirm the existence of a link between vitamin D status and     some areas of cognitive functions, and analyze the roles played by vitamin D deficiency and     cognitive impairment in the occurrence of falls. The study will also seek the existence of a     threshold level of 25-hydroxyvitamin D below which may arise cognitive disorders. The     prospective follow-up of patients for 2 years will study the effect of correcting the vitamin     D deficiency (initial correction and regular supplementation) on cognitive function, balance,     walking and the occurrence of falls.      The study will be conducted in 150 subjects aged 50 years and over and fell in 150 subjects     aged 50 and over at risk of falling. These patients will be enrolled in the Emergency     Services, Orthopedics, Geriatrics, and Rheumatology of the University Hospital of Caen. All     subjects will receive a dose of 25 hydroxyvitamin D, a comprehensive study of cognitive     function, tests of balance and walking and assessment of activities of daily living and     depression. All the examinations and tests will be carried out during the same half day.     According to current recommendations, it will be prescribed a treatment with Vitamin D to     subjects with a lowered rate of 25 hydroxyvitamin D (<30 ng / ml) to normalize the rate and     will be advised doctors to prescribe regular supplementation vitamin D in order to maintain     it in the standard rate (30 to 80 ng / ml). The effect of the correction of hypovitaminosis     D, confirmed by controlling the rate of 25 hydroxyvitamin D, on cognitive functions, balance     and walking will be analyzed 3 months and 9 months. During the two years following their     inclusion in the study, subjects will be contacted by a phone call every 3 months during     which will be recorded any falls they have been victims, as well as changes to their drug     treatments, particularly case of regular intake of vitamin D supplementation.      If our hypothesis were true, it would be appropriate to consider a new approach to prevention     of fractures involving the correction of vitamin D deficiency, cognitive rehabilitation and     cognitive-motor drive in subjects with cognitive impairment.   "
58705|NCT02517151|"     A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron     supplementation on chronic fatigue in IBD patients with controlled disease.   "
58706|NCT02517138|"     The goal of this study is to objectively determine the perceived direction of the right-front     by the subjects in weightlessness. The direction of the right-front has not been investigated     to date with the measurements of the position of the eyes. The investigators will compare the     intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent     direction of the right-front indicated by the subjects when they look right front in the dark     (LOOK) and that they indicate when they determine whether a visual target through the     right-front apparent (PERCEPTION). Then, the investigators will compare these measurements     between normal gravity and microgravity hypergravity during parabolic flight.   "
58707|NCT02517125|"     Head and Neck cancers are treated either with surgical resection followed by adjuvant     radiotherapy, or with organ preservation strategies using definitive radiotherapy with or     without concomitant chemotherapy. These treatments have long-time functional side effects and     consequences on the quality of life. Transoral robotic surgery has been developing since 2006     by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the     large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for     transoral surgery of head and neck cancers, using previous generations of da Vinci. The last     generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014     and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The     objective of our study is therefore to study the feasibility of this transoral robotic     surgery for head and neck cancers, using the da Vinci Xi.   "
58708|NCT02517112|"     3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2     missions on a single astronaut. The results from this experiment have been published in the     literature: the influence of respiration have been demonstrated and the signal processing     methodology for the reconstruction of the displacement in one cardiac cycle have been     developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained     microgravity experiment onboard the Russian segment of ISS has been initiated. To be     integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity     before implemented on ISS.      The aim of the present parabolic flight study is to serve as a feasibility demonstrator and     test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test     whether the sensitivity of the developed 3D-BCG sensor is appropriate   "
58709|NCT02517099|"     This is a single-centre, randomised-controlled trial, comparing management of preschool     wheeze. It specifically aims to compare management of preschool wheeze using current clinical     guidelines to management determined by eosinophilic inflammation and infection. Participants     will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of     two treatment groups, either current clinical care or pathological phenotype based     management. They will be asked to make 2 study visits to the Royal Brompton Hospital over the     course of 4 months.   "
58714|NCT02517034|"     This randomized clinical trial studies a geriatric assessment intervention in predicting     chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer.     Assessing patients' functional status, comorbidities, psychological state, social support,     nutritional status, and cognitive function before treatment may help identify     vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with     cancer.   "
58715|NCT02517021|"     NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two     antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if     pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting     after administration of repeated cycles of chemotherapy.   "
58716|NCT02517008|"     This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive     (mama kit) on rural facility delivery rates in Zambia.   "
58717|NCT02516995|"     Merge the data of ultrasound with that of the anatomical and functional MRI is necessary     since the high dose rate Curietherapy is carried out under ultrasound guidance. The     investigators will recruit prostate cancer patients to evaluate the quality of the data,     their sensitivity to exam conditions (patient position, volume of endorectal probe, gold     grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from     different sources with the purpose of estimating the opportunities of integration treatment     plan for Curietherapy broadband.      The nuclear magnetic resonance imaging provides precise anatomical study, but also provides     access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI),     for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic     imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context,     involving close collaboration between clinicians, medical physicists, and physicists of the     teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital     Kremlin-Bicetre).   "
58718|NCT02516982|"     The aim of this study is to determine the feasibility of using mobile technology for:        1. Implementing the recommendations of the Antenatal and postnatal mental health: clinical          management and service guidance NICE guideline for recognising depression (i.e., Whooley          questions followed by a validated screening instrument such as the Edinburgh Postnatal          Depression Scale) during pregnancy using iPad Air tablets in the waiting area of general          practices, midwifery services, or hospitals during antenatal clinics; and        2. Using a bespoke app running on pregnant women's own smartphones to monitor mood and          symptoms of depression throughout pregnancy.   "
58719|NCT02516969|"     Comparison of 1-year local control in patients with operable, recurrent previously-irradiated     squamous cell head-and-neck cancers with or without adjuvant SBRT.   "
58720|NCT02516956|"     This project aims to demonstrate that the best breakfast meal is the one able to improve the     best postprandial hunger, satiety and adiposity regulators profile as well as the best     reward-related gratification, due to hedonistic parameters. To do this, 4 different     breakfasts will be tested and blood tests, food choices, and attentional components will be     analysed.   "
58721|NCT02516943|"     Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive     care unit (SICU). These luxury investigations waste the resources. Therefore we develop a     pathological- based guideline for arterial blood gas analysis in patients after cardiac     surgery. We test the guideline for its safety and efficacy.   "
58722|NCT02516930|"     This is a pragmatic, non-inferiority, randomized controlled trial comparing the effectiveness     of two methods (crowdsourcing versus social marketing) for creating one-minute videos     promoting condom use among MSM and TG in China. Crowdsourcing is the process of shifting     individual tasks to a large group, often involving open contests and enabled through     multisectoral partnerships.   "
58723|NCT02516917|"     This study aims to investigate the application of the Attention Training Technique in     children with ADHD aged 7-11 years old. The research aims to investigate both the feasibility     of this technique in this population as well as whether it can improve symptoms, behaviour     and executive functioning.   "
58724|NCT02516904|"     A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of     CD101 IV   "
58725|NCT02516891|"     The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval     maneuvers after the jailing.      2) To determined anatomic and technical factors influencing the induced damage in the     guidewire.      Design of the study: prospective randomized study to compare 2 types of guidewire:     hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation     coronary lesions will be included. All of then will be treated by provisional side-branch     stenting using the jailed wire technique. One hundred patients will be randomized to     hydrophilic wires and another 100 patients to non-hydrophilic wires.   "
58726|NCT02516878|"     In this study, a 18-week, single-blinded, randomized controlled clinical trial will be     conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control     in Hong Kong.   "
58727|NCT02516865|"     This project aims to test the feasibility of a practical physical activity intervention for     postpartum women, incorporating the use of body weights worn during typical daily activities.   "
58728|NCT02516852|"     Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth     and development. Yet, for poor children in developing countries, ASF consumption is limited     by cost, inadequate caregiver knowledge, and lack of local production and physical     availability. The impact of HH- and village-level livestock interventions on household     dietary diversity and nutritional status in resource-poor communities is not well     established. The objective of this study is to test the effectiveness of local egg production     intervention on maternal and child diets and child nutrition status.      This project takes place in the Luangwa Valley, Zambia in partnership with a local     non-governmental organization, COMACO. Twenty communities will be assigned to the     intervention, and 20 matched communities will be selected as controls. In each intervention     community, an egg production facility will be built, owned, and operated by trained COMACO     farmers. Simultaneously, a nutrition-focused behavior change campaign will be disseminated to     all communities.      Households (HHs) in each community will be sampled twice annually for 1 year pre-intervention     (baseline) and 2 years post-intervention to assess dietary diversity and nutritional status.     Data analysis will test for a change in these outcomes from baseline in each intervention     community compared to the matched control community.   "
58730|NCT02516826|"     1. Stains have demonstrated consistent benefits to reduce cardiovascular events in several          primary and secondary prevention trials. The suppression of plaque progression or          regression may be a part of mechanism of clinical benefit. The intravascular ultrasound          studies demonstrated that intensive statin therapy can regress or inhibit the          progression of coronary atherosclerosis.        2. Unregulated renin-angiotensin system is important in the pathogenesis of cardiovascular          disease. Angiotensin receptor antagonists (ARB) have been reported to improve clinical          outcomes in patients with heart failure, left ventricular dysfunction, myocardial          infarction, and high-risk patients. Several small studies showed that ARBs were          effective to inhibit the progression of coronary atherosclerosis by intravascular          ultrasound examination.        3. The combined therapy with statins and ARBs may be additive or synergistic effects on the          atherosclerosis regression as well as to improve endothelial dysfunction and insulin          resistance in addition to lowering cholesterol levels and blood pressure when compared          with either monotherapy in patients.        4. Serial computed tomography angiography (CTA) can be utilized to assess the effect of          treatment on coronary plaque morphology. In addition to the assessment of luminal          stenosis, CTA also allows characterization of plaque morphology.   "
58731|NCT02516813|"     MSC2490484A or M3814 is an investigational drug that is being evaluated for the treatment of     subjects with locally advanced tumors. The main purposes of this study are to determine the     safety, the tolerability and the efficacy of MSC2490484A in combination with radiotherapy and     in combination with chemoradiotherapy (Radiotherapy + cisplatin).   "
58732|NCT02516800|"     Mutations in the SLC34A2 gene, that encodes the sodium phosphate co-transporter (NaPi-IIb),     cause defect cell-uptake of phosphate, which leads to formation of calcium-phosphate     concretions in the lungs as seen in Pulmonary Alveolar Microlithiasis (PAM). Extra pulmonary     calcifications, including heart valve calcification, have previously been reported in     patients with PAM.      Calcific Aortic Valve Disease (CAVD) is a common disease in the elderly and is characterised     by thickening and calcification of the aortic valve leaflets in the absence of rheumatic     heart disease. CAVD is present in more than 25% of patients older than age 65 years and is     associated with an increased risk of cardiovascular events. Currently, there is no effective     therapy for the disease other than surgical aortic valve replacement. Both calcium and     phosphate are the major components of calcific deposits in PAM and CAVD. Based on these     preliminary findings, the investigators hypothesize that mutations in sodium phosphate     co-transporters may play a role in both pulmonary and extra pulmonary calcifications.      Two studies will be performed: 1. A retrospective cross-sectional study including patients     with an age ≤ 65 years with CAVD from Denmark and Örebro, will be carried out. Genetic     association analysis will be performed to investigate the incidence of common variants in     five genes representing sodium phosphate co-transporters (SLC34A1, SLC34A2, SLC34A3, SLC20A1,     SLC20A2) compared to healthy controls. Associated genes will subsequently be sequenced to     identify possible causal mutations. 2. In a prospective study, aortic valve tissue will be     collected from patients with AS undergoing surgical valve replacement. Molecular     characterisation of the transporters will be conducted by determining the level of specific     mRNA and protein by RT-PCR/qPCR, and Western Blotting, respectively. The localisation and     visualisation will be investigated by immunostaining and confocal laser microscopy.     Fibroblasts and endothelial cells will be isolated and grown in cultures with subsequent     functional studies of the phosphate uptake.   "
58733|NCT02516787|"     Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or     bone demineralization, extended stays in weightlessness also cause cognitive dysfunction.     However, the studies on this subject during space missions short or long term could not     determine how these cognitive dysfunction resulted from a direct effect of weightlessness or     a stress-related effect.      Analysis of electro-encephalography (EEG) using a standardized mapping method is used to     study the changes of operation of the cerebral cortex as the near infrared spectroscopy     (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a     relatively simple and economical method for studying brain changes in an environment where     the normal brain imaging techniques can not be used.      The main objective of this experiment is to evaluate the alterations in brain cortical     activity and brain oxygenation level induced by micro- and hypergravity conditions.   "
58734|NCT02516774|"     The hypothesis is that the particular richness of ATC's microenvironment in TAMs creates a     unique opportunity for using Tumor Necrosis Factor blockade during chemotherapy and     radiotherapy in order to counteract tumor resistance to therapy.   "
58735|NCT02516761|"     The idea of this study is the combination of these two techniques (low-impact aerobic     exercise through functional movements and music therapy) that have proven to be effective     separately. The main objective of this study is to test this combination to reduce widespread     pain in fibromyalgia patients, improve their balance, influence on decreasing levels of     depression and improve quality of life.   "
58736|NCT02516748|"     Accurate optical diagnosis of colorectal polyps could allow a resect and discard strategy     with surveillance intervals determined based on the results of the optical biopsy. The     investigators perform education to characterize the histology of diminutive and small     colorectal polyps by using narrow band imaging (NBI). After education program, the     investigators prospectively evaluate real-time optical biopsy analysis of polyps with NBI by     16 academic based gastroenterologists.   "
58737|NCT02516735|"     The purpose of this study is to assess whether i-scan with magnification can reduce the     biopsy number needed per patient for the detection of gastric intestinal metaplasia without     the loss of corresponding diagnostic yield.   "
58738|NCT02516722|"     The objective of this study is to assess the safety, performance and initial effectiveness of     the TIVUS™ System when used for pulmonary artery denervation through subjective and objective     change in clinical parameters and haemodynamic evaluation. This is a prospective,     multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to     5 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who     have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific     medications.   "
58739|NCT02516709|"     Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer.   "
58740|NCT02516696|"     This is a randomized, open-label, phase III study to investigate the efficacy of combination     therapy with an induction phase utilizing a combination clarithromycin (Biaxin®),     lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are     newly diagnosed and require treatment when compared to patients who receive lenalidomide and     dexamethasone alone.   "
58766|NCT02516358|"     To quantify the local prevalence of diabetes mellitus in critically ill patients. To     understand whether a correlation does exist between premorbid glycaemic control and glycaemic     status in ICU. A subgroup analysis will be conducted to investigate whether a relationship     does exist between Neuron Specific Enolase levels and glycaemic disorders.   "
58741|NCT02516683|"     Background: The incidence of postinfectious irritable bowel syndrome (PI-IBS) was reported to     be in the range of 5-30%, but limited number of long-term follow-up results.      Objective: To investigate the long term clinical course of PI-IBS after Shigellosis.      Setting: A Shigellosis outbreak in a tertiary referral hospital with about 2,000 employees in     Korea at 2001.      Patients: A Shigella-exposed cohort of 124 hospital employees who had been infected by     Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance     Hospital, Seoul, Korea, at December 2001. A control cohort of age and sex-matched,     non-infected 105 contemporary hospital employees.      Measurements: Questionnaire survey for bowel symptoms at 1, 3, 5, 8 and 10 years after     outbreak.   "
58742|NCT02516670|"     This randomized phase II trial studies how well docetaxel works when given with or without     ascorbic acid in treating patients with prostate cancer that has spread to other places in     the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Ascorbic acid (vitamin C) is a water-soluble vitamin that may     help inhibit the growth of cancer cells. It is not yet known whether docetaxel works better     when given with or without ascorbic acid in treating prostate cancer.   "
58743|NCT02516657|"     The purpose of this study is to study the effect of a liraglutide, a glucagon-like peptide     agonist, on post-meal blood glucose concentrations, glucagon levels, mean weekly blood     sugars, and insulin doses in adolescents with Type 1 diabetes. Type 1 diabetes is an     autoimmune disease that is usually diagnosed before the age of 20. Individuals with this     disease are completely dependent on insulin for survival. While significant advances have     been made in technological support for improving diabetes control, insulin remains the only     effective treatment for Type 1 diabetes. Liraglutide is a long-acting glucagon-like peptide-1     analog. This drug is approved for the treatment of Type 2 diabetes in adults. This study will     test the effect of liraglutide on blood sugar control in adolescents with Type 1 diabetes.   "
58744|NCT02516644|"     The primary hypothesis of the investigators is that a virtual reality system combined with     physical activity provided on a body weight support treadmill training would change clinical     parameters of balance and mobility in people with Parkinson's Disease   "
58745|NCT02516631|"     The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol     following single dose administration in adult women being given misoprostol for cervical     ripening and induction of labour.   "
58746|NCT02516618|"     The primary objective of the study is to assess the safety and tolerability of a single dose     of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.   "
58747|NCT02516605|"     A multi-part study to assess safety, tolerability and efficacy of LJN452 in patients with     primary biliary cholangitis   "
58748|NCT02516592|"     This study will investigate whether switching symptomatic COPD patients from a fixed-dose     combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149     110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on     symptom burden, breathlessness, and use of rescue medication after this switch.   "
58749|NCT02516579|"     In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to     collect information about long-term safety of Siklos® (hydroxycarbamide) when used in current     practices for the prevention of symptomatic vaso-occlusive complications in patients with     Sickle Cell Disease.   "
58750|NCT02516566|"     The investigators aim to investigate the effects of positive end-expiratory pressure     ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in     patients undergoing robot-assisted laparoscopic prostatectomy.   "
58751|NCT02516553|"     The aim of the phase Ia (dose escalation) part of this trial is to assess the MTD of BI     894999 administered at escalating doses in two treatment schedules (schedule A of continuous     dosing, schedule B with two weeks on treatment followed by one week off in 3-week cycles) in     patients with solid tumours and for schedule A in Non-Hodgkin lymphoma patients. In the phase     Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at the     recommended dose and schedule in patients with solid tumours and to assess target modulation     and the potential antitumour efficacy in patients with selected types of tumours. Once the     MTD has been determined for both schedules in patients with solid tumours, the MTD will be     determined as well in patients with NHL, using the recommended schedule for solid tumours.The     PK profile will be determined from the first cycle in all patients in both phases.   "
58752|NCT02516540|"     The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a     structured life-style intervention program with exercise training and mediterranean diet is     effective regarding increased adherence to a mediterranean diet, reduction of body mass     index, and increase of physical fitness.   "
58753|NCT02516527|"     The purpose of this study is to determine whether ipilimumab is effective in the treatment of     select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.   "
58872|NCT02514967|"     The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a     composite responder index in subjects who, despite corticosteroid use, continue to have     seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by     SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or     C4).   "
58764|NCT02516384|"     Inflammatory bowel disease is a condition caused by gastrointestinal immune system     dysregulation and affected by both genetic and environmental factors. Differences in     intestinal bacteria exist between IBD patients and healthy controls, but the role of     intestinal bacteria in the development and treatment of IBD remains largely unknown. Fecal     microbiota transplantation (FMT) is the transfer of gastrointestinal bacteria from a healthy     donor to a patient with altered microbial diversity with the intent of restoring a normal     bacterial balance. Most studies focus on its use in treating Clostridium difficile (CDI), an     infection characterized by dysbiosis. Given the role of dysbiosis in IBD, the investigators     hypothesize that FMT may be beneficial in IBD. The purpose of this study is to prospectively     examine the safety of FMT in the management of ulcerative colitis (UC).   "
58765|NCT02516371|"     This study aims to exam the subpopulation of lymphocytes and evaluate the clinico-pathologic     correlations.   "
58754|NCT02516514|"     Current recommendations for the diagnosis of bacteremia based on the embodiment     February-March blood cultures separated by a minimum interval of 30 minutes. Each blood     culture comprises seeding a pair of aerobic and anaerobic vials inoculated each with 5 to 10     ml of blood. The sensitivity and specificity of this technique depends essentially on the     amount of blood removed since there is a direct relationship between the volume of blood     inoculated into each flask and the efficiency of the technique. A preliminary study conducted     at the University Hospital of Caen found that 14-30% of patients depending on the services     had received only one blood culture. In addition, at least four blood cultures in 24 hours     were taken for 10 to 20% of patients. The practice of a single blood culture reduces the     sensitivity of the analysis due to insufficient total amount of blood collected. The practice     of too many blood cultures increases the risk of false positive (presence of contaminating     bacteria), generates extra work for healthcare personnel (and laboratory) and represents a     significant cost for an unproven benefit.      The investigators propose to evaluate a single blood culture sampling technique with seeding     4 vials (2 aerobic and anaerobic 2).   "
58755|NCT02516501|"     Type of study: Pilot / phase I trial      Study purpose To assess the impact of a dietary intervention during radio(chemo)therapy (RCT)     on body composition changes      Trial Treatment Patients will be split into a control group and intervention group 1. If     willing to undertake a ketogenic diet for the duration of radiotherapy, patients are entered     into intervention group 2.        -  Group 1: On irradiation days irradiation after overnight fast + ketogenic breakfast          consisting of 50-250 ml betaquick® (vitaflo, Bad Homburg, Germany) and 5-15 g Master          Amino Acid Pattern (dr. reinwald healthcare gmbh+co kg, Schwarzenbruck, Germany).        -  Group 2: Complete ketogenic diet plus 5-15g Master Amino Acid Pattern/day        -  Control: No dietary intervention.        -  All groups: Weight measurements and bioimpedance analysis (BIA) once per week, routine          blood parameters and quality of life (QoL) questionnaire before, during and after RCT      Endpoints      Primary:        -  Feasibility of the dietary intervention during RCT, measured by dropout rates        -  Changes in body weight        -  BIA phase angle and quantities derived from BIA variables      Secondary:        -  QoL        -  Toxicities        -  Blood parameters        -  Grade of regression at time of surgery in case of rectum carcinomas      Inclusion criteria        -  One of the following tumor entities:             -  Breast carcinoma             -  Rectum carcinoma             -  Head & Neck Cancer        -  Histological confirmation of malignancy        -  Signed written informed consent        -  Karnofsky index ≥ 70        -  Age between 18 and 75 years        -  BMI between 18 and 34 kg/m^2      Exclusion criteria        -  Palliative patients, in particular with metastasis        -  Type I diabetes        -  Pregnancy        -  Pacemaker and other metallic parts within the body        -  Known defects in enzymes necessary for ketogenesis, ketolysis, fatty acid oxidation or          gluconeogenesis        -  Unable to speak or understand German        -  Cognitive impairments or psychological disorders        -  Renal insufficiency      Planned accrual        -  15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in          intervention group 1        -  15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in control          group        -  Minimum 5 patients of each tumor entity in intervantion group 2 Total: n ≥ 85 patients      Study procedure        1. Inclusion and full written informed consent.        2. Baseline BIA measurement and blood work        3. RCT with weekly BIA assessments; at least one blood withdrawal ± concurrent dietary          intervention        4. Final BIA measurement and blood work after radiotherapy      Follow up For rectal carcinoma: Regression at time of surgery (c and p)   "
58756|NCT02516488|"     Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination     against surgical histopathology of cystic pancreatic lesions.   "
58757|NCT02516475|"     To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory     markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of     Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg     zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the     investigators' diet . At the first and the end of the intervention,weight, body mass index     (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin,     hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups.   "
58758|NCT02516462|"     Because a large proportion of the embryo's quality is dependent upon the egg, this     investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical     IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at     this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an     impact on oocyte quality the use of in IVM is critical. Development of a successful IVM     protocol for clinical use would not only provide an option for women of advanced maternal     age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for     stimulation, and significantly lessen the risk of ovarian hyper-stimulation.      The objective of this research study is to evaluate a newly developed oocyte maturation media     system for human clinical use in assisted reproductive technology (ART).   "
58759|NCT02516449|"     The purpose of this study is to determine whether the use of shared decision making aids is     more effective than usual care in improving asthma knowledge, lessening decisional conflict,     and enhancing adherence to treatments and asthma control in adult patients with mild to     severe asthma.   "
58760|NCT02516436|"     A randomized, double blind, active controlled study in approximately 40 opioid dependent     subjects. Study duration is up to five days and includes a maximum of 3 days confinement in     the clinic. Opioid dependent subjects who provide informed consent meet all entry criteria     are eligible for enrollment into the study.   "
58761|NCT02516423|"     This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and     zoledronic acid with zoledronic acid alone to see how well they work when given after     radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Lenalidomide may help the immune system kill abnormal blood cells or cancer cells.     Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic     acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard     treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib     citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more     effective, and whether adding these treatments after radiation therapy is more effective than     radiation therapy alone in treating patients with solitary plasmacytoma of bone.   "
58762|NCT02516410|"     Study to evaluate the efficacy of VX-661 in combination with ivacaftor through Week 12 in     subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF     transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not     likely to respond to VX-661 and/or ivacaftor therapy (F508del/not responsive [NR]).   "
58763|NCT02516397|"     The purpose of this clinical trial is to evaluate the safety and efficacy of a food     supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight     subjects during 12 weeks treatment.   "
58922|NCT02514304|"     The purpose of this multicenter, two component observational and standardized case-control     study is to evaluate risk factors of gastrointestinal (GI) bleeding with a prospective     3-month and 12-month follow-up to examine outcomes and their possible causes.   "
58768|NCT02516332|"     Coronary heart disease (CHD) is the leading cause of death in the United States; more than     600,000 Americans suffer a fatal cardiac event each year. Traditional CHD risk factors such     as high blood pressure, smoking, and elevated cholesterol do not fully account for the timing     and occurrence of CHD events and individuals with elevated levels of anxiety appear to have a     greater risk of cardiovascular events. The present study will examine the impact of aerobic     exercise and Lexapro in the treatment of anxiety and cardiovascular biomarkers among     individuals with CHD.   "
58769|NCT02516319|"     The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function     Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an     adequate dose based on LFA technology and 3) determine an adequate time period for LFA     determination.   "
58770|NCT02516306|"     The purpose of this study is to determine whether EV06 Ophthalmic Solution is safe and     effective in improving distance corrected near vision in people who have presbyopia.   "
58771|NCT02516293|"     Due to the lack of information in the literature about the role of cardiac rehabilitation on     Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac     exercise program on functional capacity, cardiac function, respiratory muscle strength, body     composition, biomarkers and quality of life among Chagas heart failure patients.   "
58772|NCT02516280|"     A pilot study was performed to investigate the feasibility of a large randomized controlled     trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in     knee flexion range of motion in the first two days after total knee arthroplasty.   "
58773|NCT02516267|"     The purpose of this study is to assess platelet aggregability by a point of care device     (Multiplate®) to decrease the release time for coronary artery bypass graft (CABG ) in     patients with acute coronary syndrome (ACS) in use of dual antiplatelet therapy.   "
58774|NCT02516254|"     The aim of this study is to evaluate the efficacy of daily intake of fortified bread with     vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy     subjects compared to vitamin D supplement.   "
58775|NCT02516241|"     A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line     MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care     Chemotherapy in Patients with Stage IV Urothelial Cancer   "
58776|NCT02516228|"     This study examines the safety and feasibility of suppressing epileptic discharges through     inducing long term depression of the epileptic focus with transcranial electrical     neuromodulation.   "
58777|NCT02516215|"     This is an observational clinical study, patients with systemic diseases will be enrolled     according to the inclusion and exclusion criteria. 360 patients will received the examination     of sublingual microcirculation by using sidestream dark filed video microscope. The     microcirculation data includes total small vessel density, perfused small vessel density,     microvascular flow index, and heterogeneity index. The patients will be divided into right     groups according to their systemic diseases as follows: group 1 hypertension (60 patients),     group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60), group 4 end     stage renal disease with hemodialysis (60), group 5 peripheral arterial occlusive disease     (30), group 6 coronary artery disease (30), group 7 liver cirrhosis (30), and group 8 anemia     (30).   "
58778|NCT02516202|"     This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms     and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter     trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel,     with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function,     and to create a biorepository of specimens for future translational, mechanistic research on     the etiology of vaginal symptoms.   "
58779|NCT02516189|"     The purpose of this study is to verify the effects of a strength training program on     functional capacity, muscle performance and microcirculation in the elderly.   "
58780|NCT02516176|"     People who are living in the community following a stroke fall frequently. The ability to     take a step in response to a balance disturbance helps to prevent falls but stroke survivors     tend not to step with their paretic leg in these circumstances. This leaves them vulnerable     to falls towards their paretic side. The purpose of this study is to train paretic limb     stepping by having individuals stand sideways on a treadmill and respond to sudden     accelerations of the treadmill.   "
58781|NCT02516163|"     This is a prospective, non-randomized, study of the clinical outcomes of participants that     receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using     ShapeMatch® Cutting Guides.   "
58782|NCT02516150|"     This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not     significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with     type 1 diabetes.   "
58783|NCT02516137|"     The purpose of this study is to find out if individuals with tight hamstring muscles who     receive dry needling in addition to a standard stretching exercise program, show an     improvement in hamstring tightness and function compared to individuals with tight hamstrings     who receive either sham dry needling or no needling (blunt needle) in addition to a standard     stretching program.   "
58784|NCT02516124|"     The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem     Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc)     as currently performed by different study protocols used across Europe in various EBMT     centres through the careful recording and analysis of routinely collected clinical and     biological data.   "
58785|NCT02516111|"     The present study is designed as a single-centre, randomized, controlled clinical trial to     evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2%     atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony     defects in patients with chronic periodontitis.   "
58786|NCT02516098|"     Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated     tablets.   "
58787|NCT02516085|"     The purpose of the study is to show that the intake of L-arginine and metformin improves     muscle function and delays disease progression in patients with Duchenne's muscular     dystrophy.   "
71154|NCT02354417|"     This is an open-label, safety study of a single ProHema-CB product administered following     myeloablative conditioning regimen in pediatric subjects with hematologic malignancies.   "
58788|NCT02516072|"     With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is     rising. With approximately one quarter of all PAD patients ultimately progressing to Critical     Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to accurately     assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A & B) can be treated with     angioplasty+/- stenting and accurate assessment relies on the imaging gold standard of     angiography.      Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal     impairment placing them at increased risk of developing contrast induced nephropathy (CIN)     when exposed to iodinated contrast media. High risk individuals with decreased eGFR <60ml/min     have a risk of between 20-30% of developing CIN. They have increased morbidity and mortality     risks with a greater need for dialysis and prolonged in patient hospital stays. Ideally, the     investigators should be searching for ways to decrease the incidence of CIN. Animal studies     and more recently pilot human trials have shown that subjecting a remote vascular bed to a     brief ischaemic stress, followed by a period of reperfusion; in what has been termed remote     ischemic preconditioning (RIPC), may confer a protective benefit against the development of     CIN. This study aims to determine if RIPC can protect against CIN in patients undergoing     elective peripheral angiography for infrainguinal disease.   "
58789|NCT02516059|"     Cystectomy with urinary diversion (ileal conduit, ileal orthotopic neobladder, catheterizable     ileal pouch) is major abdominal surgery, which is associated with a high incidence of     gastrointestinal complications.Perioperative techniques aiming at an early return of bowel     function are to be pursued.      Optimal postoperative pain management is one of the key factors leading to enhanced recovery     after surgery. The perioperative use of an epidural analgesia for major abdominal surgery is     established, not only because of its excellent analgesic properties, but also because it can     accelerate the return of bowel function. However, epidural analgesia is associated with     additional costs, need for close monitoring and nursing. In addition each supplemental day     with an indwelling epidural catheter increases the risk of infection. So it is recommended to     re-assess the risk/benefit ratio of an epidural analgesia after 4 days, if not sooner.     Therefore, it is important to develop strategies that reduce its duration without impairing     the benefits. Systemic analgesics with prolonged-release oral formulation like oral oxycodone     (Oxycontin®) or combined drug mixture (oral oxycodone/naloxone (Targin®)) could be a valuable     alternative pain treatment as a second analgesic step, starting on postoperative day (POD) 3,     so that the epidural catheter could be removed earlier without impairing postoperative     enhanced recovery including return of the bowel function. Both oxycodone and naloxone orally     administered are a recognized and accepted treatment option.      The objective of this study is to evaluate the implementation of an oral opioid with or     without naloxone in the early postoperative period in patients undergoing open radical     cystectomy with urinary diversion and intraoperative and early postoperative use of epidural     analgesia. The investigators expect an unchanged early return of the bowel function and equal     analgesia with a reduced length of stay of the epidural catheter (primary endpoint), thus     potentially reducing epidural catheter associated complications and lowering costs (nursing     and pain service).   "
58790|NCT02516046|"     This study is designed to test the relationship between ante-mortem 18F-AV-1451 Positron     Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with     Alzheimer's disease (AD), as measured at autopsy.   "
58791|NCT02516033|"     Recently a combined approach of surgeon ablation in combination with endocardial ablation     (hybrid ablation) has been introduced. This therapy has shown excellent results in patients     with previous failed endocardial ablation for paroxysmal atrial fibrillation as well in     patients with persistent atrial fibrillation. The investigators hypothesize that the severity     of atrial remodeling in patients with atrial fibrillation can be measured by clinical     factors, echocardiographic parameters, circulating biomarkers and genetic background, and     that these factors can be used to identify a risk profile to predict failure of the hybrid     ablation therapy in patients with atrial fibrillation. Aim of this study is to determine a     risk profile based on clinical correlates, circulating biomarkers, and genetic background     associated with failure of the hybrid ablation procedure, in a prospective single center     registry setting. The investigators evaluate all consecutive patients who have agreed to     undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim     for a total of 250 participants. Extra study related procedures include blood sampling for     biomarkers and genetic analysis, prolonged Holter monitoring for documentation of recurrences     of atrial fibrillation/atrial flutter/atrial tachycardias, and a quality of life     questionnaire. Total follow-up will be five years.      Main study endpoint is failure of the hybrid ablation procedure in patients with atrial     fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia     >30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day     Holter monitoring.   "
58792|NCT02516020|"     To compare the effectiveness of single step culture media and continuous uninterrupted     culture media on blastulation rate   "
58793|NCT02515994|"     Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing     study of Johnson & Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared     with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI     investigational contact lenses on a daily wear basis.   "
58794|NCT02515981|"     The New Hampshire Medicaid Wellness Incentive Program (WIP) will address both the health     disparity and increased costs by providing incentivized health promotion programs to     overweight or obese and/or tobacco-smoking Medicaid beneficiaries receiving services at New     Hampshire's 10 regional Community Mental Health Centers (CMHCs).   "
58798|NCT02515929|"     Aim: To evaluate the effectiveness on tissue response of the new nutritional supplement made     of Oligomeric Proanthocyanidins (OPCs) in induced gingivitis after 21 days of use.      Material and Methods: A double-blind randomized controlled prospective clinical trial was     carried out on 20 patients divided into an experimental group treated with the OPCs pill and     a control group treated with placebo, after fulfilling the selection criteria. Patients had     to come 4 times during the study to register the Silness and Loe and Gingival Bleeding index,     plaque index, inflammatory crevicular fluid study (IL6) and changes in brightness of the     gingiva. No complementary hygiene methods were allowed during the 21 days.   "
58799|NCT02515916|"     The purpose of this study is assess the effects of oncology treatment on ovarian reserve and     also to better understand the experiences, thoughts and feelings of women scheduled to     undergo chemotherapy/radiotherapy and seeking fertility preservation at Weill Cornell Medical     College (WCMC).   "
58810|NCT02515773|"     A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and     healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body     weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and     Quality of Life.   "
60507|NCT02493569|"     The purpose of the study is to study the epidemic features and diagnosis of female breast     cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival     (DFS) and the total survival time(OS) of the breast cancer patients will also be studied.   "
58800|NCT02515903|"     Views for surgery method selection of intracerebral hemorrhage are still controversial. Since     the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed     effective and safe, some investigators have attempted to use endoscopic strategies to     evacuate intracerebral hematomas. Some significant advances have also been reported in     endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still     crucial to implement a prospective and controlled study to evaluate the efficiency and safety     of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the     investigators will exclusively select some patients with intracerebral hemorrhage in the     basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery     versus stereotactic aspiration on neurologic outcomes for patients with intracerebral     hemorrhage.   "
58801|NCT02515890|"     The purpose of this study is to determine the effects of pain on facilitating long-term     auditory memory in the presence and absence of distinct intravenous anesthetics. The ability     to identify previously presented words from a list will asses the degree of memory formation.     In a subset of subjects, functional magnetic resonance imaging will be used to identify the     neural correlates of memory inhibition or facilitation by the combination of pain and     anesthetic used. The primary hypothesis is that pain will enhance memory formation, and that     this will be mediated by additional neural pathways compared to those used to encode words     not paired with pain. The study will occur over 4-5 visits and involves no long-term follow     up.   "
58802|NCT02515877|"     The treatment of cervical tumors depends on the stage of the disease. In advanced forms     (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated     with curietherapy , plays a major role. Until recently this association was the standard     treatment for advanced stage uterine cancer. With this combination, rates of local failures     (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for     stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II     / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect     survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have     evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix.     More than 19 randomized trials have been published. A meta-analysis of these trials was     undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first     meta-analysis published by the Cochrane Collaborative Group, taking into account 4580     patient, shows an improvement in survival, both in terms of progression free survival and     overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p <     0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were     significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical     benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced,     possibly due to small number of patients. The investigators have previously shown that     antiviral agents used in preclinical models, Cidofovir® causes the selective     radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to     study a new concept to increase radiochemotherapy efficiency: the modulation of the     expression of viral oncoproteins HPV virus by an antiviral agent.   "
58803|NCT02515864|"     A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval     of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control,     in Healthy Male and Female Volunteers.   "
58804|NCT02515851|"     For patients undergoing open-reduction internal-fixaton (ORIF) of isolated distal radius     fractures, administration of 66.5 mg of liposomal bupivacaine to operative field may decrease     the need for post-operative narcotic pain medication.   "
58805|NCT02515838|"     A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate     Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis     (VOC) in Subjects with Sickle-Cell Disease (SCD).   "
58806|NCT02515825|"     The purpose of this non-significant risk study is to collect performance information     regarding the use of the CADence system under normal conditions of use. This is a     prospective, multi-center study to capture information on CADence agreement with coronary     angiograms, on subjects who are already scheduled for coronary angiography.   "
58807|NCT02515812|"     Cardiological examination constitute one of the major directions in nuclear medicine for     detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they     constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or     nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF     stratification study based on cardiac adrenergic function after injection of a tracer:     I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally     in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous     publications from 1992 to the present day have reported encouraging results for the daily use     of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in     using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961     patients. Typically, the camera used was an Anger camera with collimating Nai standard called     parallel holes.      The main objective is to validate the measurements of cardiac adrenergic function evaluated     by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection     of I-123-MIBG in 80 patients with heart failure.   "
58808|NCT02515799|"     The purpose of this study is to evaluate the mucolytic activity of Tacholiquine® compared to     saline (0.9%) in chronic bronchitis patients. Lung function parameters, biomarker profiles in     sputum and serum, and clinical symptoms by standardized questionnaires [COPD activity index     (CAT), Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)and the St. George's     Respiratory Questionnaire (SGRQ)] will be evaluated in response to Tacholiquine® vs. saline     in chronic bronchitis patients.   "
58923|NCT02514291|"     The purpose of the study is to develop and evaluate a sleep intervention program for     improving sleep and health in youth with epilepsy and their parents.   "
58809|NCT02515786|"     During normal breathing, the upper and lower airways performs the priming of inspired gas:     humidification, heating and filtering from nose to the bronchios for adequate gas exchange     occurs in the lungs. Many patients with severe or advanced cardiopulmonary conditions (cystic     fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, advanced heart     failure among others) may develop chronic respiratory failure and require treatment with     oxygen therapy. High fractions of inspired oxygen have been associated with deleterious     effects on the nasal ciliary beating and nose mucociliary transport. At home assistance, the     patient with chronic respiratory receives oxygen via nasal cannula to the patient has been     applied with and without humidification, however, does not know the effects of these two     types of dry and humidified administration on the mucosa of the nose, airways and lungs. The     investigators will assess the subject in use of home oxygen therapy at baseline, 12 hours, 7     days 30 days, 12 months and 24 months.   "
58811|NCT02515760|"     Non-small cell lung cancer is characterized by aggressive growth and treatment resistance.     New approaches include immunotherapeutic strategies but spontaneous immune responses against     tumor antigens remain unclear. The aim of this study is to characterize localization and     frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated     antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.   "
58812|NCT02515747|"     The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a)     phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease     patients divided on the basis of management strategy - medical, endovascular or open cardiac     surgery.   "
58813|NCT02515734|"     This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus     bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS     wild-type tumors.   "
58814|NCT02515721|"     Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and     gastric cancer are essential to improve patients' outcomes. This study aims to compare the     diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based     confocal laser endomicroscopy (pCLE) and iScan alone.   "
58815|NCT02515708|"     Normothermic machine perfusion (NMP) preservation is a promising method to decrease the     complication of marginal donor livers compared to cold storage (CS). The aim of this project     is to assess safety and feasibility of NMP in human liver transplantation. This will be a     single center prospective cohort pilot study. Thirty-two livers with acceptable quality for     transplantation will be preserved with NMP in 4-18 hours and transplanted. The follow-up     period will be 6 months post-transplantation. The outcome will be compared to 128 historical     patients transplanted in our program in the past 5 years (liver preserved using CS) with     matched characteristics on age, Model for End-Stage Liver Disease (MELD) score, preservation     time, etc.   "
58816|NCT02515695|"     Phase I study aiming at:        -  assessing the absolute bioavailability, pharmacokinetic profile, and dose          proportionality of interferon beta-1a (HSA-free solution in pre-filled syringes) after          i.v. and s.c. administration as well as the pharmacodynamic profile to create the link          with available surrogate markers investigated with both formulations used clinically,          lyophilisate with HSA (HSA+) and solution without HSA (HSA-);        -  gathering further information on safety and tolerability of interferon beta-1a over dose          range,including local and systemic tolerance, body temperature, vital signs, and a          battery of exploratory sickness behavior tests.   "
58817|NCT02515682|"     We propose to perform a 24-week randomized, double-blind a placebo-controlled trial among 207     non-equol producing postmenopausal women with prehypertension to examine the effectiveness of     equol (10mg and 20mg/d) on 24h ambulatory blood pressure, vascular function and other     cardiovascular risks (lipid profile, glycemic control and inflammatory biomarkers) and     explore the optimal dosage of equol.   "
58818|NCT02515669|"     The purpose of this study is to determine the safety and tolerability of BMS-986089 in boys     with Duchenne Muscular Dystrophy with any genetic mutation.   "
58819|NCT02515656|"     POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated     for the local treatment of vaginitis due to sensitive germs and treatment of non specific     vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.      Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study     supporting the interest of the combinaison of antifungal and antibiotics agents versus     antifungal agent alone.      The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole     in the treatment of women experiencing symptoms of infectious vaginitis.   "
58820|NCT02515643|"     Endothelial dysfunction one-year after transplantation mainly depends on     transplant-associated factors and only marginally on reduced renal function.      OBJETIVES Primary objective Estimate the contribution of renal dysfunction to endothelial     dysfunction in two cohorts of patients, living kidney donors and their transplant recipients.      Secondary objectives      To evaluate in both cohorts of patients before and after nephrectomy/transplantation the     evolution of the following parameters:        1. Renal function (iohexolGFR, proteinuria/microalbuminuria).        2. Blood pressure (24 h ambulatory blood pressure measurement)        3. Surrogate variables of subclinical atherosclerosis (carotid ultrasound, ankle-brachial          index, pulse wave velocity).      DESIGN Non-interventional, prospective, multicenter, longitudinal study of two cohorts:     living kidney donors and their transplant recipients.   "
58821|NCT02515630|"     This study will evaluate the transfusion independence response rate in transfusion-dependent     adults with myelofibrosis after treatment with momelotinib (MMB).   "
58868|NCT02515019|"     Electroencephalographic-based monitoring systems such as the bispectral index (BIS) may     reduce anaesthetic overdose rates. The investigators hypothesised that goal-directed     sevoflurane administration (guided by BIS monitoring) could reduce the sevoflurane plasma     concentration (SPC) and intraoperative vasopressor doses during on-pump cardiac surgery in a     prospective, controlled, sequential two-arm clinical study.   "
58822|NCT02515617|"     In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia     (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last     american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has     been notified among the basic practices to prevent VAP. Nevertheless, the diffusion of SSD     in ICUs remains limited. This situation is largely due to the initial overcost of the     specific endotracheal tubes allowing SSD and to the unavailability of these devices in     medical units in which patients are intubated before the ICU admission. So, this pragmatical     cluster randomized and cross-over study evaluates the medico-economic impact of the     subglottic secretions drainage in addition to VAP prevention bundles in ICU.   "
58823|NCT02515604|"     A randomised controlled trial assessing the efficacy of single versus repeated dose of     vaginal misoprostol for the treatment of early pregnancy failure.   "
58824|NCT02515591|"     Validation study to use the disposable bronchoscopes in healthy volunteer research     bronchoscopies to ensure adequate sample and cell yield.   "
58856|NCT02515175|"     This study evaluates the reduction in viral shedding after vaccination with a new formulation     of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will     receive GEN-003, one-third will receive placebo.   "
58826|NCT02515565|"     Acute respiratory infections are the fourth cause of hospitalization in elderly. Various     studies have examined the impact of hospitalization in patients with respiratory pathology,     showing the need of interventions in order to reduce the impact of hospitalization. The     objective of this study is to examine whether a physical therapy intervention can reduce     impairment in patients hospitalized due to pneumonia.   "
58827|NCT02515552|"     Fibromyalgia is a complex chronic illness affecting 6-12 million Americans. Self-management     strategies play a key role in reducing symptoms and maintaining functioning. The proposed     project offers a web-based self management tool that enables FM sufferers to identify     significant linkages between their personal symptom levels and their personal self-management     efforts over time in order to plan their own optimal approach to disease management.   "
58828|NCT02515539|"     The purpose of the study is to generate early US feasibility data of the CardiAQ™     Transcatheter Mitral Valve Implant System.      The study will enroll patients with moderate to severe mitral valve regurgitation who are     considered high risk for mortality and morbidity from conventional open-heart surgery.   "
58829|NCT02515526|"     Protocol title: Effect of acute alcohol consumption on the activity of major cytochrome P450     enzymes, NAT2 and P-glycoprotein.      Objectives: The study is mainly conducted to evaluate the effect of acute alcohol consumption     on the activity of the most important drug metabolising cytochrome P450 enzymes CYP1A2,     CYP2C9, CYP2C19, CYP2D6, intestinal CYP3A4, hepatic CYP3A4, NAT2 and on the activity of the     drug transporter p-glycoprotein (intestinal and renal).      The study should also provide basis for a planned clinical study on interactions caused by     chronic alcohol intake.      Design: Single center, open-label, two-way, cross-over study with randomly allocated     sequences Test-Reference or Reference-Test.      The study is not a clinical drug study according to the German Drug Act.      Clinical phase: Not applicable      Volunteers: 16 healthy male and female subjects are planned for completion in accordance with     the protocol, i.e. with evaluable/analysable data for all periods and treatments.      Clinical centre: Department of Pharmacology, Clinical Pharmacology Unit (KPH), University of     Cologne, Gleueler Str. 24, 50931Köln, Germany   "
58830|NCT02515513|"     The relationship between myopenia, nutritional status, and long-term oncologic outcomes     remains poorly characterized in patients with anatomically resectable pancreatic cancer (PC).     The investigators want to look at muscle properties in pancreatic cancer patients to     determine possible therapeutic options toward better nutritional status. Patients with benign     right upper quadrant pathology will be utilized as controls for the study.      The researchers hypothesize that improving cancer cachexia in PC will improve the quality of     life and ultimately increase overall survival. The long term goal of is to identify areas of     intervention to prevent and/or improve cachectic events in PC in order to significantly     improve clinical outcomes. The first step in this long term goal is to fully characterize     cachexia in the condition of PC. This research is to understand and modify the local response     within skeletal muscle leading to a clinically relevant persistent wasting and to understand     and interrupt the systemic stimulus produced by the tumor local environment resulting in     these muscle specific mechanisms.   "
58831|NCT02515500|"     The study is designed to evaluate the efficacy of a cigarette reduction intervention using a     novel device called the Quitbit, a digital lighter paired with a smartphone mobile     application, to enhance self-regulatory techniques for reducing cigarettes smoked per day     toward cessation.   "
58832|NCT02515487|"     The main goal of this project is to identify and remediate the cognitive difficulties,     including processing speed and attention deficits in individuals who have undergone     chemotherapy treatment. Recent research has demonstrated objective cognitive deficits     following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it     was once considered. There are a large number of woman diagnosed and treated for breast     cancer that experience chemotherapy induced cognitive deficits.      Subjects who participate in the study will be evaluated for cognitive abilities prior to     chemotherapy treatment and after completion of chemotherapy. Participants will then have the     option to participate in the second phase of the study, which involves the use of a     computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive     evaluation.   "
58833|NCT02515474|"     Protection of Oddi's sphincter remains a huge argument especially in the long term     complications like common bile duct stone recurrence or cholangitis after ERCP, which     determined to destroy the sphincter of Oddi. The purpose of this study is to compare the     long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.   "
58869|NCT02515006|"     Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom     satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective     intervention may offer a practicable solution. The aim of this study was to investigate the     clinical effectiveness of homeopathy for insomnia.   "
58834|NCT02515461|"     The investigators aim to investigate whether low energy shockwave therapy (LE-SWT) can     preserve kidney function in diabetic patients. Participants in this study will receive LE-SWT     treatment 6 times over 3 weeks. The treatment is non-invasive and has no known side effects.     Previous studies have shown that LE-SWT induces angiogenesis. The investigators hypothesize     that chromium-ethylenediaminetetraacetic acid (EDTA) renal clearance remains stable or     increases in treated patients. Furthermore, kidney biopsy should show no signs of damage to     the tissue and possibly neo-vascularization. In this project, the investigators shall also     investigate LE-SWT effect on urinary markers of tubular damage and urinary nitric oxide     indices. Patients' self-reported quality of life will be assessed using Short Form 36 version     2 (SF-36v2) Health Survey.      There is an 18-months follow-up on patients. Only patients between 18-65 years old with     moderate chronic kidney failure from diabetes will be included.      This project is an interventional prospective study. 30 patients with moderate kidney failure     will be recruited from the Department of Endocrinology, Odense University Hospital, Denmark.     LE-SWT treatment will be performed in the ambulatory of Department of Urology. Patients will     be hospitalized for 1 day in the Department of Nephrology when kidney biopsy is taken (two     times in study period).   "
58875|NCT02514928|"     This study is performed to confirm whether resection of the nerve plexus on the right half of     celiac and SMA associated with extended pancreatoduodenectomy could improve survival and     relieve pain of pancreatic cancer patients.   "
58835|NCT02515448|"     Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection     associated with the highest morbidity and mortality.      Respiratory infection with resistant organism are increasing in prevalence. Because of lack     of alternatives, amino glycoside, old antibiotics family, can be used for several infection.      Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for     respiratory infections. Gentamicin,which is effective against numerous multi drug resistant     Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option     for nebulisation.      The investigators assume that nebulisation of gentamicin allows to obtain a higher lung     concentration while assuring a systematic toxicity much lesser than a parenteral     administration.   "
58836|NCT02515435|"     The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer     treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which selectively     inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also represents mild     inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally bioavailable, small     molecule agent which is thought to inhibit VEGF-mediated endothelial cell migration and     proliferation thus blocking blood vessel formation in tumor tissues. Previous studies have     identified that apatinib was well tolerated at doses below 750mg daily. In phase I/II study,     investigators reported an objective response rate of 68%. In a phase III trial conducted in     advanced pretreated gastric cancer, the median overall survival was significantly prolonged     in the apatinib group compared with placebo group. Thus, in this trial, the investigators aim     to investigate the efficacy and safety of apatinib in previously treated advanced     non-squamous non-small cell lung cancer.   "
58837|NCT02515422|"     Aim: To assess the analgesic efficacy of subcutaneous infiltration of ketamine, either alone     or as an adjuvant to bupivacaine, following CS and to compare their effects on postoperative     pain scores and opioid consumption.      Methods: Included patients were allocated to four treatment groups using computer-generated     randomization number chart as follows; Group 1 (Ketamine, n=30) received subcutaneous     infiltration of ketamine, Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of     bupivacaine 0.5%, Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of     ketamine+bupivacaine 0.5% and Group 4 (Placebo, n=30) received subcutaneous infiltration of     placebo (0.9% saline solution). Patients, anesthetist, surgeon, and other medical and nursing     staff were blinded to the contents of the medications. VAS scores at resting and on coughing     and analgesic consumptions were compared.   "
58838|NCT02515409|"     The purpose of this study is to determine whether heated humidified high flow nasal cannula     (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to     continues positive airway pressure (CPAP) treatments in children and to compare their     adherence and compliance.   "
58839|NCT02515396|"     A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the     effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory     markers.   "
58840|NCT02515383|"     The goal of this research study is to learn if a symptom questionnaire used for adults at MD     Anderson can be improved to better understand the symptoms experienced by 13-17 year old     patients with cancer.   "
58841|NCT02515370|"     The main goal of the study is to support HIV-infected pregnant women initiated on PMTCT     Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an     enhanced group peer support intervention called friends for life circles.   "
58842|NCT02515357|"     Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent episodes of     partial or complete collapse of the upper airway during sleep, leading to pauses of breathing     and arousals. Although previously considered as a local abnormality of the respiratory track,     it is nowadays recognized as a systemic disease and an important cause of morbidity and     mortality, since it is strongly associated with obesity (especially abdominal obesity) and     cardiometabolic diseases, including cardiovascular diseases and diabetes mellitus.     Interestingly, recent hypotheses support that the metabolic syndrome pathology, including     insulin resistance, inflammation and oxidative stress may be involved in OSA pathogenesis.     The modification of lifestyle habits, e.g. in terms of diet and physical activity, is     currently explored as a mean of managing the disease in combination with the first line     treatment, i.e., the application of continuous positive airway pressure (CPAP) during sleep.     The available data support that weight loss, achieved through lifestyle modification,     effectively reduces the severity of OSA and improves the associated cardiometabolic disorders     in overweight or obese patients. However, studies exploring the potential effect of diet's     quality or other lifestyle habits (such as physical activity) on OSA severity, besides weight     loss, are currently lacking. Given that a Mediterranean dietary pattern, as well as other     lifestyle habits adopted by the populations in the Mediterranean region, have been proven     beneficial both for the prevention and the resolution of the metabolic syndrome and its     associated cardiometabolic diseases, the aim of the present randomized, controlled,     single-blind study is to implement an intensive intervention based on the Mediterranean     lifestyle (hypocaloric diet and 7 group lifestyle counselling sessions) and to evaluate its     potential benefits, compared with standard care (hypocaloric diet and written advice for     healthy lifestyle), in a sample of patients with OSA.   "
58870|NCT02514993|"     -  Analysis of patient data and computed tomography scan of polytraumatized patients          thoracic spine fractures        -  A concomitant sternal fracture was identified an indicator for an unstable thoracic          spine fracture   "
58871|NCT02514980|"     this study will be undertaken to evaluate the safety and analgesic efficacy of adding     ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain     postoperatively following repair of cleft lip in children less than two years of age.   "
58843|NCT02515344|"     Objective : to demonstrate that providing to GPs a list of their patients who are not     compliant to colorectal cancer screening will 1) enhance patient participation to screening,     and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design     : Randomised controlled study, 3 parallel arms. Enrollment: GPs allocated in the 3 groups of     the study will be all GPs 1) from the Loire-Atlantique and Vendée geographic area (1300 GPs     on average) and 2) who have more than 100 patients in their patient list (based on data     provided by the Healthcare Insurance System Services). Patients will be eligible to the study     depending on their eligibility to the Faecal Occult Blood Test for colorectal cancer     screening : 1) they should be older than 50 and younger than 74; 2) they should not have a     personal history of colorectal cancer (or history of adenoma bigger than 1 cm) nor a family     history of colorectal cancer. Main outcomes measures : Patient participation to colorectal     cancer screening, and number of cancers screened in (versus diagnosed outside) the screening     procedure.   "
58844|NCT02515331|"     The purpose of the present study is to determine whether LHW090 displays the clinical safety     and efficacy profile to support further development in patients with resistant hypertension.   "
58845|NCT02515318|"     Chronic Obstructive Pulmonary Disease (COPD) is projected to be the fifth leading burden of     disease worldwide by the year 2020. An acute exacerbation of COPD (AECOPD) is defined as an     acute event characterized by a worsening of the patient's respiratory symptoms that requires     a modification in the medication. AECOPD are frequent (mean of 1-4 exacerbations each year).     It increases in frequency with the severity of the disease. The objective of this study is to     examine whether a physical therapy intervention can reduce impairment in patients with COPD     during hospitalization due to an acute exacerbation.   "
58846|NCT02515305|"     The purpose of this study is to compare the safety and efficacy of Perrigo's product to an     FDA approved product for the treatment acne vulgaris   "
58847|NCT02515292|"     Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and immunological     by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of neonates with     intrauterine growth restriction (IUGR) and the integration in a multidimensional statistical     model .      Objectives:        1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor          gene expression in cord blood from newborns with intrauterine growth restriction (IUGR).          (Prospective)        2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and          paraclinical. (Retrospective & prospective)        3. Evaluation and monitoring of morphological and functional by echocardiography.          (Prospective)        4. Integrating multidimensional clinical and paraclinical parameters in a statistical model          for evaluating newborn with intrauterine growth restriction.   "
58848|NCT02515279|"     This noninterventional, open-label study will observe the safety and tolerability of     peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for     HCV infection according to routine practice.   "
58849|NCT02515266|"     Postnatal growth is a crucial in premature infants as it could be correlated with the     long-term cognitive development. Optimal nutritional care is required to reduce the initial     weight loss and further growth deficit.      The quantitative objective is to achieve growth that is at least equivalent to that of the     fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often     grow during difficult 10-15 first days of life, so they accumulate a delay that should     compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than     15 g/kg.day.      Individualized fortification of human milk (HM) has been proposed to optimize postnatal     growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal     growth in preterm infants.      The objectives of this study are to determine the effectiveness of additional protein     fortification (APF) in terms of short-term growth along with the proportion of extremely low     birth weight (ELBW) infants requiring APF.   "
58850|NCT02515253|"     The purpose of this study is to assess whether prescribing a bra to participants results in     an improvement in the Patient Global Impression of Change (PGIC) compared to participants who     receive standard care alone.   "
58851|NCT02515240|"     The purpose of the study. To characterize the immune response to the pneumococcal vaccine in     HIV positive individuals and to dissect the most appropriate timing and frequency of     vaccination.   "
58852|NCT02515227|"     This study evaluates whether it is safe to administer a peptide vaccine in combination with     pembrolizumab. This study will also evaluate the effects of the combination of the peptide     vaccine and pembrolizumab on the immune system. The investigators will monitor these effects     by performing tests in the laboratory on participants' blood, a lymph node, and tumor     samples.   "
58853|NCT02515214|"     The use of bariatric surgery has risen subsequently over the last decade, especially in women     of reproductive age. (Unplanned) pregnancies in this subgroup are not rare because of e.g. an     increased fertility (because of the weight loss) and a possible ineffectiveness of     contraceptives (because of a malabsorption in the intestine). Although a pregnancy after     bariatric surgery is generally known as safe, there are a few studies that indicate that a     pregnancy after a bariatric surgery is not always without complications, and that it should     be considered as a high risk pregnancy. The research on pregnancy outcomes after this type of     surgery is rather limited to a few small, mainly retrospective, observational case-control     and cohort studies and a limited amount of case studies. For risk- and prognose related     issues, e.g. the effect of bariatric surgery on fertility, timing of the pregnancy,     development of complications during the pregnancy and pregnancy outcomes, large prospective     cohort studies are needed. Besides, breast feeding practices and breast milk composition have     scarcely been investigated in this population. The energy content of breast milk could     possibly be influenced by a state of malabsorption after the procedure. Low amounts of     vitamin B12 have also been noticed in the breast milk of women the surgery. The overall     objective of this study is to establish a group of women at reproductive age (age 18-45) with     a history of bariatric surgery and to generate an extensive database for future analysis. The     final goal of the researchers is to develop guidelines or recommendations on how to manage     pregnancies after bariatric surgery, based on large-scale prospective research.      The study design is a multicentric observational and prospective cohort study. Participants     will be followed from the moment of surgery until 6 months postpartum and they can be     included on several time points (before surgery, after surgery (<12 months); after surgery     (>12 months) or during the pregnancy). Both retrospective and prospective data concerning the     medical background, fertility (menstrual cycle), lifestyle (e.a. food, physical activities,     smoking, sleeping), blood samples, psychological factors (fear and depression), sexuality,     quality of life and pregnancy outcomes will be collected. Data collection by the     investigators will happen in a web-based database and by direct online registration by the     subjects.   "
58854|NCT02515201|"     Clinical trial, that aim is evaluation of the use of taurolidine and heparin in the     prevention of bloodstream infection in venous catheter in children with intestinal failure.   "
82637|NCT02204345|"     A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and     paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.   "
58855|NCT02515188|"     Sedation for catheter ablation of atrial fibrillation should be performed to achieve     analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as     propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However,     propofol and midazolam causes respiratory depression and dexmedetomidine occasionally     accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that     does not induce respiratory depression with stable hemodynamics is needed.      Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st     line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption     after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators     hypothesized that addition of propacetamol to previously used sedatives     midazolam-remifentanil will reduce opioid consumption during the catheter ablation.      Therefore, the investigators designed this study to investigate the role of addition of     propacetamol to previous used midazolam-remifentanil sedation. This study will compare the     opioid consumption and respiratory effect of propacetamol with placebo-control for catheter     ablation of atrial fibrillation.   "
58857|NCT02515162|"     In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two     electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure,     will be compared. The primary outcome of the study is dysplasia-free resection margin rate,     secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention     time, postoperative pain, intra- and postoperative complications, the resected cone volume     and users satisfaction.   "
58858|NCT02515149|"     Randomised Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost     Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and     Time to Antiretroviral Therapy Initiation among HIV Infected Patients in Rural Western Kenya.   "
58859|NCT02515136|"     In a computerized experiment, visual stimuli will be presented to the parkinson's disease     patients and to the controls. They will respond to each image by acting on the keyboard in a     specific manner. Each participant will repeat that task 384 times per session. A break will     be inserted every 12 tests so that participants can rest.      The experiment consists of three sessions. Each image will be presented three times. For the     first two presentations it is assumed that a link will be created between the image and the     task, and the image and action. In the third presentation, the same task and the same action     will be maintained or will be swapped. In this way, It can be checked whether associations     thus generated will affect the performance of the participants when tasks and actions will be     incongruent.   "
58860|NCT02515123|"     Early enteral feeding is a key component of the management of critically ill patients     receiving mechanical ventilation. However, enteral feeding has been associated with serious     complications such as gastro-esophageal reflux, with both overt and micro pulmonary     aspiration, which potentially increases the risk to nosocomial pneumonia. Many critically ill     patients experience poor tolerance of early enteral nutrition because of impaired gastric     motility, which leads to a sequence of delayed gastric emptying, increased gastric volume,     gastro esophageal reflux, vomiting, aspiration, and VAP. Early and adequate enteral feeding     in ICU patients is correlated with decreased overall infections rates, ventilator and     intensive care unit (ICU) days, costs, and mortality.      This study is intended to assess the efficacy and safety of the E-Motion System (i.e.     E-Motion tubeTM and E-Motion EPG 1000TM) in improving tolerance to enteral nutrition by     inducing esophageal motion by means of electrical stimulation in ICU patients.   "
58861|NCT02515110|"     Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional     nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment     groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam     radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3)     plans for locoregional EBRT following mastectomy with reconstruction.      Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other     EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with     reconstruction, cosmetic outcome.   "
58862|NCT02515097|"     Evaluate the safety and efficacy of a topical lotion when applied once daily to adult     subjects with moderate to severe plaque psoriasis.   "
58863|NCT02515084|"     The purpose of the study is to evaluate the concordance between the 18F-PET/CT under     thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the     detection of residual mass in 40 patients with partial response or relapsed differentiated     thyroid carcinoma.   "
58864|NCT02515071|"     Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic     blood pressure in multiple populations as well as increase organ perfusion in areas of     interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is     associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of     dietary nitrate in OSAS has not been reported.   "
58865|NCT02515058|"     The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to     examine histologic wound healing following ridge preservation using bone allograft that has     been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire     protocol involves procedures that are standard care. All materials are FDA-approved materials     being used in an FDA-approved manner. The test group subjects will have extraction sockets     grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test     group will be compared to an active control group using cancellous freeze-dried bone     allograft (called FDBA). The null hypothesis is that there will be no significant difference     in formation of new vital bone between treatment groups (primary outcome).      Each subject will provide a single non-molar tooth site for study treatment. After tooth     extraction, the graft material will be placed and covered by a resorbable collagen membrane.     Following 3 months of healing, the dental implant will be place, at which time a core of bone     will be removed from the site as part of the preparation for the implant. The core biopsy     will then be evaluated for the primary histologic outcome of % vital bone formation and     secondary histologic outcome of % residual graft material.   "
58873|NCT02514954|"     Each subject will be randomly allocated to a sequence of two treatments applied at two     separate dosing visits. At each dosing visit subjects will be injected with individualised     doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a     standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at     both dosing visits of one individual and will be administered subcutaneously in the abdominal     region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home     in the evening before each dosing visit. Subjects will attend the clinical site in a fasted     state in the morning of each dosing day and stay at the clinical trial centre until 10-hour     after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing     visits will be separated by a wash-out period of 5-15 days.   "
58874|NCT02514941|"     The purpose of this study is to evaluate pharmacokinetics of paracetamol, amoxicillin and     talinolol in morbid adipose subjects before as well as shortly after and about one year after     proximal Roux-en-Y Gastric Bypass (RYGB) and to measure messenger ribonucleic acid (mRNA)     expression and protein content of duodenal and/or jejunal drug metabolizing enzymes (eg.     cytochrome P450 isoenzyme 3A4 (CYP3A4), uridine diphosphoglucuronosyltransferase (UGTs)) and     drug transport proteins (e.g. P-glycoprotein, MRP2, OATPB, PEPT) before and during the     operation and about one year after proximal RYGB.   "
58876|NCT02514915|"     The primary goal of this research study is to determine the efficacy of giving pre-operative     radiosurgery to patients pending resection of a brain metastasis.   "
58877|NCT02514902|"     In the search for a novel marker of stroke that could be rapidly assessed in blood, the     investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (< 15     min) detects levels of a biomarker that is released into blood following neuronal injury     associated with stroke and traumatic brain injury. The protein's expression in human brain     should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.   "
58878|NCT02514889|"     Investigators from the University of California-Los Angeles (UCLA) and The Children's Clinic     of Long Beach (TCC) are conducting a randomized, controlled comparative effectiveness trial     of two government-sanctioned behavior change approaches to weight control with TCC's obese     patients. The first approach is the calorie-counting calorie restriction (CC) approach used     in the Diabetes Prevention Program. The second approach is the high-satiation/high-satiety     approach represented by MyPlate.gov. The MyPlate nutritional goal is to double patient fruit     and vegetable intake, legume intake, and whole grain intake. Both conditions stipulate 150     minutes of moderate physical activity a week. Study participants will be 300 of TCC's obese     patients, 75% of whom are expected to be Latino, 15% African American and 10% Other     Ethnicities.      The interventions will be implemented by trained community lifestyle change coaches with     brief support from clinicians. The interventions will include two home visits, two group     education sessions and seven telephone behavior change coaching sessions.      Compared to the CC approach, the MyPlate approach is hypothesized to yield better 12 months     patient-centered outcomes, particularly self-reported satiety.   "
58879|NCT02514876|"     This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac     Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation     procedures.   "
58880|NCT02514863|"     Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing     diverging results. With electrode position being a suspected factor influencing measurement     accuracy or reproducibility for impedance cardiography in general, no data is currently     available on altering the gap of the two lower electrodes in EV. Reference values were     determined using the non-invasive gold-standard cardiac magnetic resonance imaging (CMR).   "
58881|NCT02514850|"     This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period     cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin     treatment. Each subject will be randomly allocated to a treatment sequence and will be     administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog®     Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus®     during three separate dosing visits.   "
58882|NCT02514837|"     A malignant tumor has higher temperature than normal tissue and the temperature of the tumor     is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of     tumor activity.      The temperature changes begin in the stage of atypical hyperplasia and increased     proliferation and this opens up the possibilities for detection of patients with high risk     lesions.      Microwave radiometer (RTM-01-RES) allows measurement of temperature changes of internal     tissue at the depth of several centimetre and allows visualization of the temperature on the     thermogram and temperature field.      It is noninvasive and the measurement of internal temperature is based on receiving natural     electromagnetic radiation from the tissue in the gigahertz (GHz) frequency range. The device     is absolutely harmless and has no risk because it does not emit any radiation. It can be used     repeatedly as a method of monitoring.      Microwave radiometry has successfully completed seven clinical trials of more than 1000     patients in different countries. Microwave device (RTM-01-RES) is used in more than 300     medical centers in 30 countries.      Medical technology of microwave radiometry is included in the nomenclature of medical     services in the Russian Federation, the Ministry of Health and is part of the standard of     care for patients with malignant tumors of the breast.      This method of microwave radiometry is recommended by leading Russian mammalogists in the     National guidelines of breast care.      The investigators would like to use the device in clinics in Scotland and later United     Kingdom (UK) for breast diagnosis and monitoring treatment.      During 3 months the investigators aim to examine 150 patients with breast cancer and 150     patients without cancer who will be the control group. The results of temperature measurement     will be compared with the results of histology, in particular, tumour cellulants p53     expression and other gene expression data for metabolic biomarkers and other tumor indicator.     Statistical analysis of data will be performed. The device and initial training will be     provided by RES Company (device producer).   "
58883|NCT02514824|"     This research study is studying a targeted therapy as a possible treatment for merkel cell     carcinoma.      - The name of the study intervention involved in this study is: MLN0128.   "
58884|NCT02514811|"     The Northwest Coalition for Adolescent Health (NWCAH) replicated the Teen Outreach Program     (TOP) in five states across the pacific northwest including Idaho, Alaska, Montana, Oregon,     and Washington. The purpose of this study is to measure: at the end of the program year, were     TOP students less likely than control group students to report ever being pregnant or causing     someone to be pregnant?   "
58963|NCT02513758|"     Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial     cells, Langerhans cells) and antibodies may also play a critical role. The investigators'     study aims to precise the role of each type of cells, the interaction cell-cell and     cell-antibodies.   "
58885|NCT02514798|"     Patients affected with severe parenchymal pulmonary diseases, such as Chronic Obstructive     Pulmonary Disease (COPD ), may experience dyspnea at rest due to increased work of breathing     and reduced oxygenation. The delivery of high-flow humidified nasal oxygen (HFNC) has been     shown to have a positive-end-expiratory pressure (PEEP) effect and is able to flush out CO2     from the upper airways, reducing dead space ventilation. Furthermore it has been proven to     reduce the respiratory rate shortly after its initiation. These multiple actions offer the     potential of changing the respiratory pattern and reducing work of breathing, improving the     efficiency of breathing.      In this short-term, physiological, open, randomized, cross-over pilot study the investigator     swill describe the effects of varying settings of high-flow nasal oxygen on respiratory rate,     tidal volume, and diaphragmatic work of breathing in patients with severe COPD. The     investigators will also describe changes in gas exchange and effects on the subjects' comfort     and dyspnea and the breathing responses to varying setting of CPAP in the subject population.   "
58886|NCT02514772|"     The study objective is to identify potential safety risks of the transition from US-licensed     Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to     continuous treatment with the originator product in terms of general safety and     immunogenicity.   "
58887|NCT02514759|"     The Women's Clinic of Kansas City (TWC) replicated the Teen Outreach Program (TOP) across     Kansas City, Missouri. The purpose of this study is to measure: one year after the end of the     program year, what is TOP's impact on the treatment group's sexual activity and contraceptive     use, relative to the control group, at one year following the program?   "
58888|NCT02514746|"     This study aims to understand the persistence of the Japanese encephalitis (JE) antibody     response in previously vaccinated children. The proposed study is a phase 4 open-label trial     enrolling up to 818 Bangladeshi children who had previously participated in a lot to lot     consistency study (JEV05) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).   "
58889|NCT02514733|"     This is a single center study that seeks to study the impact of donor age on recipient     outcomes in older kidney transplant recipients.   "
58890|NCT02514720|"     The purpose of this study is to investigate the effects of nicotine metabolism on occupancy     of [11C]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence     and smoking during an abstinence. This will be a Positron Emission Tomography (PET) study and     the radiotracer [11C]-(+)-PHNO (11C]-( + )-4-propyl-     3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol) will be used.   "
58891|NCT02514707|"     Study Title: Outcomes of HIV infected individuals after ten years on antiretroviral treatment     Short Title/Study ID: ALT cohort Protocol Version and Date: Version 1.0 June 2013 Clinical     Phase: NA Methodology: Prospective observational study Study Duration: 01 January 2014- 30th     June 2025 Study Centre(s): Single centre (Infectious Diseases Institute, Kampala, Uganda)     Number of Subjects: Enrollment of 1,000 study participants. All patients discharged from the     IDI Research cohort (10 years of follow up on ART) will be offered to participate in the     study. Additional patients with similar characteristics will be enrolled from he clinic     Diagnosis and Main Inclusion Criteria: HIV patients above 18 years and in their 10th year of     ART Main Exclusion Criteria: ART started outside IDI Study Product, Dose, Route, Regimen: ART     will be provided according to standard of care at IDI and according to the WHO and Ugandan     guidelines Duration of follow up: 10 years Reference therapy, Dose, Route, Regimen: Not     applicable Recruitment Schedule: 1 January 2014- 30 June 2015 Statistical Methodology: Time     to event analysis (end of treatment, failure, death, switch, occurrence of drug toxicities)     including Kaplan-Meier curves and Cox regression will be performed. Endpoints will be     correlated with characteristics at ART start and at study enrollment. Possible confounding     variables, if available, will be considered.      GCP Statement: This study will be conducted in compliance with the protocol, the current     version of the Declaration of Helsinki, and ICH-GCP as well as all national legal and     regulatory requirements.   "
58892|NCT02514694|"     LEO 32731 (Study Drug) is an investigational drug which is being developed by LEO Pharma     A/S (the Sponsor) for treatment of psoriasis. The aim (s) of this Study are to determine:        -  The safety and tolerability of the Study Drug and any side effects that might be          associated with it        -  The Study will also measure how much of the Study Drug that gets into the blood and how          long time it takes for the body to remove it.   "
58893|NCT02514681|"     The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab     and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in     locally advanced or metastatic breast cancer patients for previously treated with pertuzumab   "
58894|NCT02514668|"     Primary Objective:        -  Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with          relapsed/refractory multiple myeloma (RRMM).        -  Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall          response rate (ORR) in RRMM patients previously treated with daratumumab.      Secondary Objectives:        -  Part A:        -  To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.        -  Part B:        -  To evaluate the safety of SAR650984 (isatuximab).        -  To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response          (DOR), clinical benefit rate (CBR) and progression free survival (PFS).        -  To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at          baseline.        -  To evaluate the immunogenicity of SAR650984 (isatuximab).   "
58895|NCT02514655|"     Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes     excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP)     and early tracheal lesions resulting from intubation with decreased discomfort, morbidity,     and nursing workload.      The main objective of the investigators is to show that Nosten® device is more effective than     monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP     occurrence.   "
58990|NCT02513394|"     This is a prospective, two arm, international, multicenter, randomized, open-label Phase III     study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine     therapy for patients with HR+ / HER2- early breast cancer (EBC).      The purpose of the PALLAS study is to determine whether the addition of palbociclib to     adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-     early breast cancer. Assessment of a variety of correlative analysis, including evaluation of     the effect of palbociclib in genomically defined tumor subgroups, is planned.   "
58896|NCT02514642|"     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used     clinically for the prevention of atherothrombotic events in patients with acute coronary     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT)     have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to     clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment     elevation. However, few East Asian patients (or those of East Asian descent) have been     included in these trials to assess the use of these drugs. In Korea and Japan, it has been     reported that low doses of ticagrelor might have a more potent inhibition of platelet     aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with     stable coronary artery disease, respectively. But it is still not clear whether a low dose of     ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients. A recent     study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma     concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice     daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in     healthy Chinese volunteers compared with Caucasian subjects. This data also suggested that a     low dose of ticagrelor might be more appropriate for Chinese ACS patients. In view of a large     diurnal variation with a single daily dose, a lower dose twice daily may be a better choice     for Chinese patients. Therefore, the investigators performed this randomized, single-blind,     crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg     twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable     coronary artery disease.   "
58897|NCT02514629|"     The purpose of this study is to examine the effects of metformin, testosterone, or both, in     males with obesity-related hypogonadism. This study will evaluate changes in insulin     resistance, weight loss, body composition, testosterone levels,quality of life and erectile     dysfunction.      Obese men will receive diet and physical activity counselling, and be randomised to either     testosterone, metformin, a combination of both or placebo   "
58898|NCT02514616|"     The investigational device that will be used in this trial is the EndoStim® Lower Esophageal     Sphincter (LES) Stimulation System.      The purpose of this trial is to evaluate the safety and the effectiveness of electrical     stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of     subjects with gastroesophageal reflux disease (GERD).      The study population will consist of subjects diagnosed with pathological GERD as defined by     abnormal pH and who complain of heartburn, regurgitation or both for > 6 months, on a daily     PPI use.   "
58899|NCT02514603|"     The primary purpose of this study is to assess the tolerability of prexasertib in Japanese     participants with advanced solid cancers.   "
58900|NCT02514590|"     The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord     Stimulator (SCS) System for treatment of chronic pain utilizing high frequency (10,000 Hz)     waveforms in comparison to traditional stimulation settings.   "
58901|NCT02514577|"     Evaluate the safety and efficacy of a topical lotion when applied once daily to adult     subjects with moderate to severe plaque psoriasis.   "
58902|NCT02514564|"     This study evaluates the effects of different volumes of aerobic exercise training in     cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac     rehabilitation program.   "
58903|NCT02514551|"     The main purpose of this study is to evaluate the efficacy of an alternative dose of     ramucirumab in combination with paclitaxel in participants with second-line metastatic or     locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).   "
58904|NCT02514538|"     Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as     bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well     known, due to the sodium content it has raised a hypothesis that may interfere with the     control of that risk factor.      Therefore, the objective of this study is to evaluate the effect on blood pressure of     effervescent paracetamol compared to non-effervescent, in hypertensive patients.      This is a multicenter, randomized, controlled, crossover, open, phase IV clinical trial,     which compares the effect of two different formulations of paracetamol (effervescent or     non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks     treatment (coded EUDRACT 2010-023485-53). The washing time between the two periods is     approximately 1 week (minimum 3 days)   "
58905|NCT02514525|"     To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the     treatment of previously-untreated (treatment naïve) Barrett's Esophagus (BE)   "
58906|NCT02514512|"     A research study into a new technology for adjustment of the radiotherapy beam to account for     movement of lung tumours as the patient breathes during radiotherapy.   "
58907|NCT02514499|"     The overall goal of the proposed research is to evaluate the uptake of testing and     longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2     negative patients. This model will inform the selection of the outcomes and potential     mediators and moderators of these outcomes, to inform the debate over utility, risks, and     benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.   "
58908|NCT02514486|"     This study will describe patient-reported symptom burden and concerns, quality of life (QOL),     and health behaviors of breast cancer(BC) survivors who have completed initial treatments     (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a     web-based platform to collect patient-reported outcome (PRO) data, and evaluate provider     satisfaction following delivery of an electronic health record (HER)/EPIC summary of these     PROs. Secondary aims will estimate differences in referral to available services between     those providers exposed to the PRO summary and historical controls. BC survivors who have     completed initial treatment and present within the first year following treatment for an end     of treatment (EOT)/survivorship focused visit will be the focus of this study.   "
58909|NCT02514473|"     To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects     aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF     transmembrane conductance regulator (CFTR) mutation   "
58910|NCT02514460|"     This is a randomized study comparing stent and plaque excision systems in treatment of lower     limb (superficial femoral or popliteal artery) ischemia.   "
82638|NCT02204332|"     The purpose of this study is to determine efficacy and safety of cabazitaxel administration     in patients with colorectal cancer resistant to standard treatment.   "
58911|NCT02514447|"     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor     efficacy when administered prior to topotecan in patients previously treated for     extensive-stage SCLC.      The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a     randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase,     Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first     dose with study treatment and completes at the Post-Treatment Visit. The open-label portion     enrolled 32 patients and the randomized portion will enroll approximately 90 patients.   "
58912|NCT02514434|"     The investigators will investigate the usefulness of ultrasonography versus non-contrast     magnetic resonance imaging for surveillance of hepatocellular carcinoma through this     prospective, randomized trial.   "
58913|NCT02514421|"     The purpose of this study is to see how well electrochemotherapy works at treating people     with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines     electroporation and chemotherapy administration. Electroporation uses an electric current to     produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher     concentration of administered chemotherapy agent. This study will test the safety and look at     the effect of electrochemotherapy in the treatment of stage III pancreatic adenocarcinoma.     This study will also help to find the safest and most effective amount of electroporation     voltage to apply to this type of tumor.   "
58914|NCT02514408|"     This pilot clinical trial studies the impact of radical cystectomy (surgery) on the expulsion     (release) of circulating tumor cells into the blood stream in patients with bladder cancer.     Significant surgery such as radical cystectomy may cause the expulsion of tumor cells.     Studying the release of tumor cells into the circulation may help doctors understand the     impact that radical cystectomy has on tumor metastasis and/or tumor recurrence.   "
58915|NCT02514395|"     Background:      KOOS is a self -administered instrument which assesses the patient's opinion about the Knee     associated problems. For now it is available in English & various other languages & is a     complete instrument in itself.      In India it has been translated in Hindi so far. However, each province in this country has a     unique language. Maharashtra is the second largest state in India and Marathi is the regional     language of the communication. Since KOOS is a self‐report measure, its translation in this     local language was thought to be necessary. This disease specific measure which is originally     designed for English speaking region when employed to non-English population needed to be     translated with unique method to achieve a normative equivalence and linguistic validation.      Methods: After taking permission from KOOS web manager T1, T2, T12, B1 & B2 versions were     formatted according to the guidelines laid down by AAOS for cross cultural adaptation of     health status measure. T12 version was sent for the field testing. Total 32 subjects who met     the eligibility criteria were Included in this study.      Results:      Statistical analysis for reliability with test re‐test method suggested Perfect correlation     (r =1) between day 1 & 2. A range of 0.83‐0.54 co‐relation co‐efficient (r) demonstrated the     validity of KOOS and its subscales when compared against the 8 different domains of SF‐36.     All this correlations were statistically highly significant. Sport and recreation subscale     had many missing responses since many items in this subscale were not appropriate for the     Maharashtrian cultural set-up. Participants additionally provided the information about other     functional activities which were difficult to execute due to knee associated pain and     disability.      Conclusion: Marathi version of KOOS is proved to be a reliable & valid measure. Future scope:     this study demonstrate a need to undertake the cross cultural adaptation since a constant     pattern of impairment revealed in the execution of daily activities such as sitting on the     floor and attending certain yoga postures etc.      Key words: linguistic validation, disease specific self-report, KOOS, Marathi translation,     quality of life.   "
58916|NCT02514382|"     This phase Ib trial studies the safety and best dose of wild-type reovirus in combination     with bortezomib and dexamethasone and to see how well they work in treating patients with     multiple myeloma that has returned (relapsed) or does not respond to treatment (refractory).     A virus, called wild-type reovirus, may be able to infect cancer cells and slow the cancer     growth and kill cancer cells. Bortezomib and dexamethasone may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Giving wild-type reovirus     together with bortezomib and dexamethasone may be a better treatment for multiple myeloma.   "
58917|NCT02514369|"     Some genetic polymorphisms are known to interfere with ARV metabolism and are therefore     likely to explain some of the inter-individual variations (efficacy,toxicity,resistance)     observed during ART. The most common form of human DNA variations consists of a change of a     base in the nucleotide sequence of an individual at a given position, the single nucleotide     polymorphism (SNP). Therefore,the purpose of this research will be the identification and     characterization of the clinical impact of several SNPs in gene coding for transport proteins     (e.g.ABCB1,ABCC1) and biotransformation enzymes (e.g.CYP3A4,CYP2B6) known to be involved in     the pharmacokinetic pathway of selected ARV drugs for which the therapeutic response is     difficult to predict. Aside,the influence of these SNPs on the response to treatment     (CD4+cell,viral load) and on the toxicity will be evaluated. Plasma concentrations of ARV     drugs correlate with therapeutic efficacy but also with the risk of toxicity and of     virological failure, which is the basis of the therapeutic drug monitoring. However,given the     intracellular location of HIV, analyzing intracellular drug concentrations is fundamental and     the investigators will also focus of this new topic.   "
58918|NCT02514356|"     The purpose of this study 'SMS as an Incentive To Adhere' (SITA) is to test two novel     approaches of using SMS messages (provision of information about electronically measured own     adherence, as well as in combination with group adherence level) to improve adherence to     anitretroviral (ART) and pre-ART prophylaxis among youth age 15-24 at an HIV clinic in     Uganda.   "
58919|NCT02514343|"     This study evaluates the effect of 10% magnesium sulfate in the rehabilitation of the wrist     mobility in patients with distal radius fracture treated with percutaneous pinning and     plaster   "
58920|NCT02514330|"     The objective of the present study was to determine the effect of interval session running at     high intensity with 1% or 10% gradient on the height of the drop jump. The cinematic     variables concentric phase, eccentric and contact time were compared after the running     session in both conditions in order to explain possible changes in the jump performance. The     investigators theorize that the lower eccentric overload in the running to 10% inclination     promotes higher deleterious effect on power performance of the lower limbs   "
58921|NCT02514317|"     The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome     resistant to medical treatment, clinical course after percutaneous treatment under ultrasound     guidance. 40 patients will be included in the study. The following parameters will be     evaluated: patient satisfaction, pain, functional disability, quality of life and time to     return to work. The medico-economic aspect will be analyzed.   "
58924|NCT02514278|"     Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A     new concept suggests organ preservation as an alternative to rectal excision in good     responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase     quality of life. The rational is the fact that 15% of patients have sterilized tumours after     radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III     trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm)     received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between     local and rectal excision. The main findings were: the rate of complete pathologic response     was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and     good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes.      The objective of the new trial is to increase the proportion of patients treated with organ     preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has     been shown to enhance the response rate. In patients with colorectal metastases, response     rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also     increases response and chance of R0 resection rates in initially unresectable colorectal     metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months     of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect     to increase chance of organ preservation rate, as compared to radiochemotherapy alone.   "
58925|NCT02514265|"     This study is the second phase of the MAPP Network and is designed to conduct a prospective,     observational study of men and women with UCPPS, referred to as the Symptom Patterns Study     (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further     investigate clinical and biologic factors associated with worsening and/or improvement of     reported urinary and non-urinary symptoms.   "
58926|NCT02514252|"     The goal of this clinical research study is to learn if an investigational dose of fentanyl     sublingual spray (FSS) can help to control pain in patients with advanced cancer when given     in an outpatient and inpatient setting.   "
58927|NCT02514239|"     The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI     836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory     multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for     further development will be determined. This will depend on the safety data,     pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary     objectives are to document the safety and tolerability of BI 836909, to perform     pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in     terms of parameters of efficacy.   "
58928|NCT02514226|"     Background: Association between periodontal disease (PD) and chronic obstructive pulmonary     disease (COPD) has been widely studied and the aspiration of periodontal pathogens is one of     the most accepted causal mechanisms for pulmonary exacerbation. Bronchiectasis is clinically     quite similar with COPD, including chronic administration of antibiotics, increased systemic     inflammation and relatively similar clinical symptoms, but for the time being; there are no     studies that have correlated this condition to PD. This study will evaluate if the scaling     and root planning (SRP) associated with photodynamic therapy improves periodontal clinical     parameters, halitosis, and the quantity of microorganisms associated with exacerbation of     bronchiectasis in saliva, subgingival periodontal microenvironment, sputum and nasal lavage     at baseline, after 3 months and one year of SRP. Methods/Design: Ninety patients with chronic     periodontal disease and bronchiectasis will be enrolled in the study and they will be treated     as follow:G1 control (n = 30) - supragingival scaling (SS) and dental hygiene orientation     (DHO); G2 experimental (n = 30) - SRP + DHO; G3- experimental (n = 30) - SRP + PDT + DHO. The     quantification of bacterial groups commonly associated with exacerbation of bronchiectasis (P     aeruginosa, S. aureus) and periodontal diseases (P. gingivalis), will be evaluated in     periodontal pockets, saliva, nasal lavage and sputum by quantitative PCR at baseline 3 months     and one year after the SRP. G1 patients will receive SRP upon completion of the     investigation. If the mean depth of probing of this group worsen (> 1mm) at 3 months they     will be excluded from the study, treated (SRP) and the data will be described. Discussion:     The results of this protocol will determine the efficacy of periodontal treatment in     decreasing the total amount microorganisms in saliva periodontal pocket, sputum and nasal     lavage, the most probable niches of bronchiectasis exacerbation, and reducing local     inflammation and halitosis after 3 months and one year. It is expected an higher improvement     in all parameters measured over 3 months and 1 year for G3   "
58929|NCT02514213|"     This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150     alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by     electroporation (EP) in men with biochemically relapsed prostate cancer.   "
58930|NCT02514200|"     The purpose of this study is to determine whether individualized, topography-based corneal     crosslinking for keratoconus can improve the optical outcomes of the treatment.   "
58931|NCT02514187|"     The purpose of this study is to evaluate technetium-99m (99mTc) pertechnetate produced by a     cyclotron as a replacement for 99mTc pertechnetate obtained from a generator containing the     parent isotope Molybdenum-99 (99Mo). 99mTc pertechnetate is currently used in nuclear     medicine departments across the country. 99Mo is produced by a number of ageing nuclear     reactors across the world and severe shortages of the isotope have occurred in the past few     years. Cyclotron-produced 99mTc offers an alternative decentralized production method on a     regional basis. Since the manufacturing process is different, the safety and efficacy of     cyclotron-produced 99mTc pertechnetate must be evaluated in human subjects to enable its     routine clinical use.   "
58932|NCT02514174|"     Continuos treatment until progression or occurence of intolerable Adverse Event (AE) or end     of trial. The end of trial is one year after the last patient has entered the study.   "
58933|NCT02514161|"     The aim of this study is to assess if an intervention of manual therapy and motor control     exercises combined with an inspiratory muscle training program is more effective than an     inspiratory muscle training program alone in increasing the maximum inspiratory pressure in     moderate smokers. In addition, the study pretends to evaluate the changes caused by the     intervention regarding possible postural changes and thoracic diameter.   "
58934|NCT02514148|"     The purpose of this study is to know wich combination of treatments are the most effective in     patients with chronic migraine. The study design is a simple blind randomized controlled     trial (outcomes assessor). The study population: Men and women aged from 18 to 70 years old     with chronic migraine for at least 12 weeks. Interventions: A combination of techniques     during 6 weeks (6 sessions; 1 per week)   "
58935|NCT02514135|"     The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal     hypertension and abdominal compartment syndrome in consecutive intensive care admissions     using broad inclusion criteria.   "
58936|NCT02514122|"     A randomized double blind control trial to investigate the safety and efficacy of     subcutaneous ketamine for control of post operative pain in low resource settings.   "
58937|NCT02514109|"     The diagnosis of sensory neuronopathy is difficult to establish because the only certainty     criterion is based on the detection of specific lesions in the posterior spinal ganglion     which is usually not possible. There is to date no clinical and electrophysiological criteria     or validated biomarker for the diagnosis of this type of neuropathy. In a retrospective     study, we analyzed the files of patients with peripheral sensory neuronopathy certain and     established clinical and electrophysiological diagnostic criteria for sensitive neuronopathy.     We therefore wish now validate these criteria and investigate possible associated antibodies     on a prospective cohort of patients.   "
58947|NCT02513966|"     There is a decrease in the amount of blood components used during cardiac surgery in the last     four years. As the hemovigilance team of the investigators' Hospital the investigators want     to find out the causes and effects of this decrease.   "
58948|NCT02513953|"     Objective:To present an extremely rare site of occurrence of endometriotic cyst in the layers     of Broad Ligament.      Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in     lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were     performed in emergency.Oblong cyst structure,41x21x23mm in the left adnexa,away from ovary     and uterus was identified and excised by Four Port laparoscopic interventional surgery.   "
61195|NCT02484573|"     This study seeks to investigate whether non-selective beta blocker treatment decreases     intestinal permeability in cirrhotic patients by altering the expression of genes encoding     intercellular junction proteins.   "
58938|NCT02514083|"     Background:        -  Chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL) are tumors of          abnormal B cells that often affect elderly patients. Studies have identified critical          factors required for the growth of CLL cells. First, CLL cells survive because they          receive signals through the B-cell receptor. Second, CLL cells benefit from interactions          with other cells, especially T cells.        -  Survival signals through the B-cell receptor can be reduced with ibrutinib, which is a          pill taken daily by mouth. Ibrutinib has been approved by the U.S. Food and Drug          Administration to treat CLL patients.        -  T cells that interact with CLL cells can be removed by fludarabine, which is a drug          given by vein and has been widely used to treat CLL. By adding a short course of          fludarabine, we hope to complement the action of ibrutinib and restore a healthier          immune system.      Objectives:      - To determine if ibrutinib and a short course of fludarabine can be used safely and     effectively to treat CLL or SLL.      Eligibility:        -  Diagnosed with CLL or SLL requiring treatment        -  No prior treatment for CLL or SLL        -  Age greater than or equal to 18 years        -  Not pregnant or breast-feeding women        -  Adequate kidney and liver function      Study Design:        -  This is a phase II study of 32 patients.        -  Participants will be screened with blood tests and physical exam for eligibility.        -  Eligible participants will be treated with ibrutinib and a short course of fludarabine;             -  Treatment is given in cycles. Each cycle is defined as 28 days. Treatment continues               as long as it is effective and safe for participants.             -  Ibrutinib is taken by mouth starting on the first day of cycle 1. Ibrutinib is               continued daily.             -  Fludarabine is given through vein on the first five days of cycle 3 and 4 only.               Each infusion takes approximately 30 minutes.             -  Participants will also take drugs that prevent infections and other complications.        -  Participants under treatment will have clinic visits with tests including:             -  Medical history             -  Physical exam             -  Blood and urine tests             -  CT and PET scans: They will lie in a machine that uses a computer to take serial               images of the body.             -  For the PET scan, a radioactive sugar is injected into a vein for clear               visualization of the body.             -  EKG: To assess heart rhythm.             -  Bone marrow and lymph node biopsies        -  Participants should avoid grapefruit, Seville oranges, and grapefruit juice during the          study. They also should avoid any live vaccines.   "
58939|NCT02514070|"     Background:      - Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are     substances found in foods such as cold-water fish and shellfish that are essential for good     health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA) and     docosahexaenoic acid (DHA) on metabolism. They may be beneficial to cardiovascular health.      Objective:      - To understand the effects of EPA and DHA on metabolism.      Eligibility:      - Healthy people ages 18 years or above with plasma triglyceride (a type of fat in the blood)     levels of 100 mg/dL or higher      Design:        -  The study will last 20 to 24 weeks.        -  Participants will have 4 visits to the NIH Clinical Center. These will include:        -  Medical history        -  Physical Fasting blood and urine tests        -  CAVI tests: blood pressure is taken in the arms and legs, and the heart is monitored.        -  Participants will take an EPA/DHA dietary supplement. They will take 4 gel capsules, 3          times a day, for 6 or 7 weeks. Then they will not take the capsules for 8 to 10 weeks (a          wash-out period). They will then take the capsules again for 6 or 7 weeks.        -  Participants will keep a food journal.   "
58940|NCT02514057|"     Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well     established and validated questionnaires that do not fully fit the requirements of an     investigator concerned about gastrointestinal side effects in a patient without primary     gastrointestinal disease.   "
58941|NCT02514044|"     The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine     (Dexedrine) and transcranial direct current stimulation with melodic intonation therapy for     treatment of aphasia after stroke. The target population is patients with chronic speech     deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed project     will help in the design of future larger studies.The safety phase will use cross-over,     placebo controlled and single-blinded design. 10 participants with post stroke chronic     non-fluent aphasia will undergo two experiments. To study the safety and effect of combined     dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized,     sham and placebo controlled, and double-blinded design in which 48 participants with post     stroke chronic non-fluent aphasia will be randomly assigned to receive either 1)     dextroamphetamine therapy with active stimulation, 2) placebo medication with active     stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with     sham stimulation for the same duration.   "
58942|NCT02514031|"     This is a study of ARQ-761 (beta-lapachone) with gemcitabine/nab-paclitaxel chemotherapy in     subjects with advanced (metastatic, unresectable, or recurrent) pancreatic cancer that has     not been treated with gemcitabine.   "
58943|NCT02514018|"     The re-activating nature of Varicella Zoster Virus (VZV) may allow life long boosting when     used as a vaccine vector in conjunction with HIV to generate durable immunity systemically     and at the mucosa. This study aims to characterize mucosal immunity before and after     vaccination with a commercial live-attenuated varicella-zoster virus vaccine with respect to     immune activation state, mucosal homing properties and VZV-specific effector immune responses     in healthy women at low risk for HIV acquisition.   "
58944|NCT02514005|"     It is a randomized clinical trial comparing two treatments in patients affected by the     patellofemoral syndrome (PFS). Our aim was to investigate the effectiveness of inclusion of     trigger point dry needling into the management of idividuals with patellofemoral pain     syndrome.   "
58945|NCT02513992|"     Ictal SPECT with intravenous injection in a cubital vein of a perfusion tracer is an     established technique to localize the ictal onset zone during presurgical evaluation of     refractory focal epilepsy. When seizures last less than 10 seconds, localizing information is     often not obtained. Since it takes around 30 seconds before the tracer reaches the brain     after intravenous injection, ictal hyperperfusion most likely has already switched to     postictal hypoperfusion. In this study, we plan to inject the perfusion tracer in the aorta     proximal to the cerebral arteries, which will allow a true ictal injection in patients with     seizures of short duration.   "
58991|NCT02513381|"     This is a double blind randomised placebo-controlled study involving women with polycystic     ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo     for three months. The main hypothesis of this study is Vitamin D improves hormonal,     metabolic and cardiovascular risk markers in women with PCOS.   "
58946|NCT02513979|"     An angiotensin II type 2 receptor (AT2R) antagonist has been assessed for its efficacy in     neuropathic pain with promising results. A considerable number of patients undergoing surgery     under general anesthesia are hypertensive and receive drugs to control high blood pressure,     including angiotensin II receptor antagonists. These drugs may attenuate the acute and/or     chronic postoperative pain or decrease the analgesic requirements after surgery. The aim of     the present study is to assess the early postoperative pain and analgesic requirements in     patients treated with antagonists of the angiotensin II receptors for at least three months     before surgery compared to normotensive patients.   "
58949|NCT02513940|"     Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with     corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the     US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in     women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for     drug-induced TdP in men, possibly due to declining serum testosterone concentrations.     Available evidence shows an inverse relationship between QTc intervals and serum testosterone     concentrations. In addition, experimental data, including those from the investigators'     laboratory, suggest that both exogenous testosterone or progesterone administration may be     protective against prolongation of ventricular repolarization and TdP. Specific Aim:     Establish the influence of transdermal testosterone administration and oral progesterone     administration as preventive methods by which to diminish the degree of drug-induced QT     interval prolongation in men 65 years of age or older. Hypothesis: Transdermal testosterone     administration and oral progesterone administration both effectively attenuate drug-induced     QT interval response in older men. To test this hypothesis, transdermal testosterone, oral     progesterone or placebo will be administered in a 3-way crossover study to men 65 years of     age or older. QTc interval response to low-dose ibutilide will be assessed. The primary     endpoints will be individually-corrected QT interval (QTcI) response to ibutilide, in the     presence and absence of testosterone, and in the presence or absence of progesterone: 1)     Effect on pre-ibutilide QTcI, 2) Effect on maximum post-ibutilide QTcI, 3) Effect on % change     in post-ibutilide QTcI, and 2) Area under the QTcI interval-time curves.   "
58950|NCT02513927|"     Hypertension is one of the most common cardiovascular diseases, which is a major risk factor     for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in     hypertensive patients was based on the average blood pressure (BP) measured in the clinic.     Accumulated data has shown that target-organ damage is related not only to 24-h mean     intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension.     Growing evidence demonstrated that BPV has considerable prognostic value for all-cause     mortality and cardiovascular outcomes, independent of average BP.      At present, the normal range of BPV is not very clear. There are many studies about the     effects of different kinds of drugs on blood pressure, but the clinical researches about the     impacts of antihypertensive drugs on BPV are limited, and the conclusion is still     controversial.   "
58951|NCT02513914|"     Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is characterized     by elevated intracranial pressure, headache, and if severe, vision loss. IIH is difficult to     treat. Medical management may not adequately resolve the symptoms, and surgical management     (primarily through cerebrospinal fluid [CSF] shunting) has a high failure rate. Recently, a     relationship between IIH and stenosis of the dural venous sinuses (the veins that drain blood     from the brain) has been reported. In patients with IIH in whom there is stenosis of one or     more dural venous sinuses, placing a stent in the venous sinus may improve patients'     objective symptoms (such as visual loss and papilledema) and subjective symptoms (such as     headache). This study will determine whether dural venous sinus stenting is as effective as     CSF shunting (considered the standard surgical treatment) in treating IIH patients who have     moderate vision loss and stenosis of the dural venous sinuses.   "
58952|NCT02513901|"     HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS)     can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected     people must remain on treatment continuously to avoid viral rebound and progression to AIDS.     HIV persistence is thought to stem primarily from the presence of integrated copies of the     proviral genome within long-lived cells. Because active viral gene expression causes cell     death due to viral cytopathic effects and the immune response, long-lived cells likely harbor     transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular     reservoirs remains a major barrier to a cure. HDACi have the potential to activate (Kick)     these latently infected cells. This will make the HIV infected cells visible to the immune     system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate     (Kill) the infected cells. The purpose of this study is to evaluate the safety and efficacy     of multi-dose Chidamide in combination with antiretroviral therapy in HIV-infected adults     with suppressed viral load.   "
58974|NCT02513602|"     The evaluation of the bone, using several techniques and on several aspects will be the     purpose to study the possible impact of the kidney transplant (and, extensively, the     pre-transplant dialysis, the organ replacement and the immunosuppressive therapy) could have     on the bone metabolism and on the density of the bone where the implants are placed. The     assessment on the bone density only in a retrospectively selected population that underwent     the same surgical procedure will help the comparison of the data to get a satisfactory     conclusion. The evaluation of other clinical and instrumental parameters in the test group     makes the kidney-transplant patients bone quality clear, and will consequently demonstrate if     implants are a feasible therapy for these patients.   "
59025|NCT02512939|"     This study will assess the next generation of blood tests for latent TB infection, which may     be able to indicate how treatment is working as well as in diagnosis infection.   "
58953|NCT02513888|"     PREVENT-WIN study has three components.      The work plan will have the following S&T components. Component 1: Cross-sectional Study      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened     randomly for the vitamin D deficiency and its determinants including duration of sun     exposure.      Component 2: Prospective Study      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women     with vitamin D deficiency. The women will be recruited from cross-sectional study, out     patient department and health camps and they will be followed up for 2 years. The women will     be randomized into two groups; lifestyle modification counseling along with intervention with     either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed     periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of     vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be     compared.      Component 3: Information Education and Communication (IEC) Activities:      There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas.     IEC material will be developed and IEC activities through various modes like lectures,     workshops, group discussions, leaflets/booklets distribution and audio video media shows     (Hindi and English) will be used for educating health professionals, Medical and paramedical     workers and various village level health functionaries like, Multi purpose workers, anganwadi     workers, Accredited Social Health Activist under National Rural Health Mission of Government     of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the     benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and     adverse health effects of vitamin D deficiency.   "
60525|NCT02493335|"     The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide     orodispersible tablets versus placebo for the maintenance of clinico-pathological remission     in patients with eosinophilic esophagitis.   "
58954|NCT02513875|"     The work plan will have the following S&T components. Component 1: Cross-sectional Study      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened     randomly for the vitamin D deficiency and its determinants including duration of sun     exposure.      Component 2: Prospective Study      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women     with vitamin D deficiency. The women will be recruited from cross-sectional study, out     patient department and health camps and they will be followed up for 2 years. The women will     be randomized into two groups; lifestyle modification counseling along with intervention with     either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed     periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of     vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be     compared.   "
58955|NCT02513862|"     The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is     effective in reducing allogeneic blood transfusions during aortic surgery using deep     hypothermic circulatory arrest.   "
58956|NCT02513849|"     Cancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive 5     years once diagnosed. It is more common in men than women, and men appear to have a worse     prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which     exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well     described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors     are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer     however, is less well defined. Work conducted by the investigators, as well as another     research group in Australia showed that antioestrogens including tamoxifen, reduce     oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the     effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators propose     a study to determine the effect of tamoxifen in patients with oesophageal cancer who aren't     undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for 4 weeks     after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a flexible     camera that is passed into the mouth through the gullet into the stomach). The biopsy will be     compared with the biopsy taken at the time of diagnosis to determine if tamoxifen has had any     effect on cancer cell growth. If this study shows that tamoxifen does slow cancer cell growth     it could lead to a larger study of patients with oesophageal cancer taking tamoxifen for a     longer time period to determine if there is any clinical benefit.   "
58957|NCT02513836|"     In this vital study, the investigators will develop an innovative Opioid Safety (Op-Safe)     Program for use in pain clinics. The Op-Safe Program consists of two key components:     Educating patients with an informative brochure and video developed by the Institute for Safe     Medication Practices (ISMP) Canada, and a screening algorithm to identify unrecognized sleep     apnea in patients taking opioids for chronic non-cancer pain.   "
58958|NCT02513823|"     This pilot study will examine the effectiveness of vitamin D supplementation on reducing     blood pressure and improving endothelial function. Premenopausal African American women will     be recruited. Potential subjects will have systolic and diastolic blood pressure measured     following the American Heart Association Blood Pressure Guidelines. Any individual with an     average blood pressure > 140/90 mmHg will be referred to their personal physician for follow     up. Participants with blood pressure readings <140/90 mmHg will be consented and then     instructed to record food intake for three days to estimate usual dietary intake at baseline     and at the 10th week timepoint. At the baseline clinic visit a 10 week supply of vitamin D3     supplements (2,000 IU/day; Nature Made ®) will be given to participants and log sheets     provided to record supplement intake. For the baseline and the 10 week visits, participants     will fast overnight and refrain from consuming any caffeinated products, vitamins, or     medications that may affect vascular tone, and will refrain from smoking. Three successive     systolic and diastolic blood pressure measurements and the average of the last two     measurements will be calculated. Anthropometric and body fat distribution assessments will be     performed. Height and weight will be measured. Percent body fat will be determined by     bioelectric impedance (Tanita BF-350) by C Moore. Body mass index (BMI) will be calculated as     weight in kilograms (kg) divided by height squared (m2). Pulse amplitude tonometry (PAT) will     be measured with the EndoPAT 2000 (Itamar Medical Ltd) which records digital pulse wave     amplitude (PWA) using fingertip plethysmography. A reactive hyperemia index (RHI) measures     nitric-oxide dependent changes in vascular tone. Endothelial dysfunction is classified as a     RHI < 1.67 with average normal endothelial RHI values ranging between 1.7 and 2.0. Blood will     be drawn for measurement of serum 25(OH)D concentrations by chemiluminescence immunoassay(     Abbott Architect). Vitamin D deficiency will be defined as serum 25(OH)D levels less than 20     ng/mL (50 nmol/L) and vitamin D insufficiency as 21 to 29 ng/mL (50 to 80 nmol/L).     Descriptive statistics, including means and standard deviations for continuous variables and     frequencies and percentages for categorical variables, will be calculated for study     variables. To answer the primary research questions, within subjects repeated measures     analysis of variance (ANOVA) tests will be conducted to test if any differences in blood     pressure, serum 25(OH)D concentrations, and RHI are statistically different after 10 weeks of     supplementation with 2,000 IU/d of vitamin D. Furthermore, exploratory multivariate linear     regression models will be constructed to determine relationships between vitamin D status and     vascular function parameters (blood pressure, RHI) before and after adjustment for age and     BMI.   "
58959|NCT02513810|"     DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is     required for patients treated with DES for prevention of late or very late stent thrombosis.     which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that     consists of a stainless steel stent platform with a textured abluminal surface without use of     any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give     BioFreedom the advantages of both DES and BMS that may require less duration of DAPT.     BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety     and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with     different duration of DAPT. With proven adequate and safe duration, we will compare between     one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents     implantation using different properties of BioFreedom and BioMatrix Flex.   "
58960|NCT02513797|"     This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the     safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left     Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI)     catheter ablation in the treatment of subjects with symptomatic persistent or longstanding     persistent atrial fibrillation.      This study will be conducted in two stages:        -  Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites        -  Pivotal Stage (Stage 2): up to 600 subjects at up to 65 sites All patients from both          stages will be included in the primary analysis.   "
58961|NCT02513784|"     This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine     mouthwash can alter the esophageal and gastric cardia microbiome   "
58962|NCT02513771|"     The purpose of the study is to evaluate whether sitagliptin (Januvia is the brand name for     sitagliptin) reduces inflammation and immune activation markers in HIV-infected men and women     when compared to a placebo (inactive medication like a dummy pill). The study will evaluate     whether taking 100 mg of sitagliptin by mouth daily for 16 weeks is safe and effective for     HIV-infected persons on antiretroviral therapy (ART) who do not have diabetes. Sitagliptin is     a medication that is used to treat people with diabetes (high blood sugar) but also may     reduce inflammation in the body.   "
58976|NCT02513576|"     Sternal instability caused by mediastinitis is one of the most feared complications for     cardiac surgery team for generating large commitments and functional damages to patients.     Biomechanically, the contraction of abdominal muscles such as transverse abdominal, produces     forces that result in a corset-like action and anterior thoracic cage muscles too may     assist in stabilizing the sternum. Thus, strengthening the abdominal muscles might contribute     to the recovery of functional aspects. The aim was to evaluate whether contraction and     strengthening the abdominal muscles could improve lung function and respiratory muscle     strength in patients with sternal instability.   "
58977|NCT02513563|"     The purpose of this study is to find out what effects (good and bad) AZD1775 used in     combination with carboplatin and paclitaxel will have on participants and their cancer.   "
58978|NCT02513550|"     The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in     participants with plaque psoriasis.   "
59128|NCT02511600|"     The goal of this clinical research study is to compare Progel® (a type of surgical sealant     that is made from human blood products) to the standard of care (talcum powder) to learn if     one method is better than the other for preventing air leaks in patients having a pleurectomy     decortication.   "
58964|NCT02513745|"     Nowadays cataract patient's expectations are closer to those of refractive surgery patients.     Patients want to be spectacle independent. However, fifteen to twenty percent of cataract     surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes     achieving spectacle independence unlikely in this patients unless the astigmatism is treated     at the time of cataract surgery. Option to treat this astigmatism include corneal or limbal     incisions (LRIs), the use of toric intraocular lenses (IOLs) or LASIK. Regardless of the     treatment of choice to correct the astigmatism at time of cataract extraction, a treatment     plan has to be calculated preoperatively. This planning include: keratometry measurements and     the use of a calculator to estimate the treatment and orientation of IOL and/or placement of     the LRIs.      New technology has been developed and is widely used. Among this technology, we have the     VERION Image Guided System. This system encompasses a reference unit that takes a picture of     the eye with the patient in the sitting position creating image of the patient's eye,     capturing scleral vessels, limbus and iris features. It measures keratometry as well as the     corneal diameter (limbus) and pupil size. The information captured is transferred     automatically to its planner where IOL power calculation and astigmatism correction     calculation are completed. Additionally, intraoperative wavefront aberrometry has been used     in the last couple of years with increase success.   "
58965|NCT02513732|"     The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition     Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.   "
58966|NCT02513719|"     The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real     world practice in Japanese hospitals.   "
58967|NCT02513693|"     Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and     clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a     neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between     optimal surgical conditions (sufficiently deep block) and capability to antagonize the block     rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep     neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous     recovery or reversal of the block with neostigmine, administration of sugammadex at the end     of the surgery will enable quick and consistent reversal of the block. Project is focused on     comparison of the parameters of deep and standard neuromuscular blockade - surgical     conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).   "
58968|NCT02513680|"     In today's society, the search for keeping up with the appearance with no visible signs of     aging has become common. Therefore, many therapies to try to mitigate these senility markers     are present in specialized clinics. Such therapies seek grounding in the theories of how the     skin and its appendages respond to the aging process, causing this way, they can be created     ways to slow or minimize wrinkles and other consequences of this natural biological process.     However, this process can be accelerated by exposure to ultraviolet light such as to toxic     substances as well as tobacco, among others. The low-power laser and light emitted diode     (LED) characterized by being non-ablative light source, which means phototherapy which does     not cause physical damage to the epidermis, as the case of CO2 laser ablative and other     methods. This study has the purpose of comparing the effects of combined application of low     level laser with LED and LED action alone in facial rejuvenation. For this, the analysis of     these effects will be conducted through digital photography, blinded assessment and customer     satisfaction questionnaire.   "
58969|NCT02513667|"     The purpose of this study is to see if Ceritinib can target ALK in non-small cell lung cancer     and slow down cancer growth and prevent it from spreading.   "
58970|NCT02513654|"     This Pharmacokinetic (PK) study is going to provide supplemental PK data for supporting     bipolar Phase III study for New Drug Application (NDA) filing according to regulatory     requirement. The primary objective of this study is to evaluate the PK of lamotrigine     following repeat dosing of lamotrigine dispersible tablet in healthy Chinese subjects. This     study consisted of Screening Phase (Days-14 to 0), Open-label Phase (Days 1 to 51) and     follow-up Phase (10-17 days after last dosing). After signing the informed consent and     confirm the eligibility, subjects will start dosing with lamotrigine 25 mg dispersible tablet     once daily at Day 1 and remain at this dose level for two weeks (Days 1-14), then will be     titrated to 50 mg once daily at Day 15 and last for weeks 3-4 (Days 15-28), and then titrated     to 100 mg once daily at Day 29 during weeks 5-6 (Days 29-42). The total duration of the study     will be approximately 10 weeks including screening and follow-up phase.   "
58971|NCT02513641|"     The purpose of this study is to determine if 2-weeks of nightly exposure (7-12 hours) to     moderate hypoxia (~2,400 meters or 7,500 feet) improves glucose metabolism in people with     type 2 diabetes.   "
58972|NCT02513628|"     Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day     after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath     diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works     showed that ONSD measurement could be used to predict outcome in post-CA patients.      The aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement     to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in     post-cardiac arrest patients treated with therapeutic hypothermia (TH).   "
58973|NCT02513615|"     Peritoneal dialysis (PD) is a type of kidney replacement therapy for patients with chronic     kidney disease where the peritoneal membrane is used to filter the blood. Exposure to PD     fluid results in scarring of the peritoneal membrane and increased blood vessel growth. This     condition can progress even when peritoneal dialysis is stopped. Therefore, the investigators     hypothesize glucose in the dialysis fluid may result in DNA modifications called epigenetic     changes. These changes modify how genes are expressed and how cells function. The     investigators want to study these epigenetic changes and the effect on peritoneal membrane     scarring, blood vessel growth and peritoneal membrane function.   "
58975|NCT02513589|"     Evaluating an innovative molecular imaging technique to visualize inflammation of the     atherosclerotic plaque in patients with a recent ischemic stroke (<15 days) with carotid     stenosis> 50%, by performing a Positron emission tomography-computed tomography (PET-CT) with     PBR06 18F, a tracer for Translocator protein (TPSO).   "
63641|NCT02452606|"     The purpose of this study is to investigate the genetic variants of clock and narcolepsy     genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients     with Parkinson's Disease.   "
58979|NCT02513537|"     The ESA is currently preparing a guideline on the management of postoperative delirium (POD),     which attempts to reduce the impact of postoperative delirium and provide recommendations for     prevention, diagnostics and treatment of delirium outside the intensive care unit. The     guidelines are going to be published during 2015.      While the guideline provides recommendations for daily practice, assessment of current     practice and knowledge is of utmost importance, because the implementation and the     measurement of a change in clinical practice will be dependent on these measurements.      This Survey has been approved by the Scientific and Research Committees of the European     Society of Anaesthesiology (ESA), the Media Committee of the ESA, as well as the     institutional ethical committee of Charité - Universitätsmedizin Berlin.   "
58980|NCT02513524|"     High blood pressure is a risk factor for bad clinical events, such as heart failure, stroke,     kidney failure and death. This risk is much higher in those with 'resistant' hypertension, in     whom the blood pressure remains high despite more than 3 blood pressure medicines. Current     estimates of the proportion of individuals with resistant hypertension may be an     overestimate, since some of them are not actually adherent (i.e. not taking the medicines     they are prescribed). Methods to detect non-adherence, such as asking the patient, counting     pills, and getting records from pharmacy are not fool proof. Direct observed therapy (where     patients are administered medicines under observation by a health care personnel) is quite     useful to diagnose this, and is the standard of care in the Renal Hypertension Clinic, before     more tests and interventions (such as CT scans, renal angiogram) are performed.      In this study, the investigators will measure the proportion of patients with resistant     hypertension who are non-adherent based on direct observed therapy, and follow them up to     examine the impact of this diagnosis.   "
58981|NCT02513511|"     Awake intubation is a recommended safety procedure in specific cases where the intubation or     ventilation before general anesthesia is at risk.      Numerous techniques to allow awake intubation have been described, such as pure awake     technique, local anesthetics or intravenous sedation for example.      Hypnosis is used for various operating room techniques and surgeries. The investigators aim     to analyze the feasibility of awake laryngoscopy and intubations on patients placed under     hypnosis alone.   "
58982|NCT02513498|"     This phase II trial studies how well ixazomib citrate works in treating patients with chronic     graft-versus-host disease. Chronic graft-versus-host disease is a complication of a donor     bone marrow or blood cell transplant, usually occurring more than three months after     transplant, in which donor cells damage the host tissue. Ixazomib citrate may be an effective     treatment for chronic graft-versus-host disease.   "
58983|NCT02513485|"     The purpose of this study is to learn more about the changes that happen in the brain and the     body when a person is depressed. This study will determine if the level of inflammation in     the body is related to symptoms of depression, how well the person thinks, and how certain     brain regions communicate.   "
58984|NCT02513472|"     This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in     combination with pembrolizumab in participants with metastatic triple-negative breast cancer     (mTNBC) previously treated with 0 to 2 lines of systemic anticancer therapy (cytotoxic or     targeted anticancer agents) in the metastatic setting.   "
58985|NCT02513459|"     This is an open label, single group, long term safety extension trial to provide a long-term     treatment option for subjects who responded to treatment with BI 655066/ABBV-066     (risankizumab) in a preceding trial.   "
58986|NCT02513446|"     The primary objective of this trial is to investigate the effect of multiple doses of     itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of     safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore,     the pharmacokinetics of the metabolite BI 1072668 will be explored.   "
58987|NCT02513433|"     This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine     and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.   "
58988|NCT02513420|"     Levator Ani Muscle (LAM) avulsion occurs in 13-36% of women having their first birth. These     damages by palpation and ultrasound of the pelvic floor can be detected. Avulsion of the LAM     results in decreased muscle strength of the pelvic floor, enlarge the genital hiatus and     promotes pelvic organ prolapse. The perineal muscle training is a proposal to combine the     perineal massage with pelvic floor exercises in order to prepare the LAM in the last weeks     before delivery, to withstand stretching which will be submitted during childbirth. No     studies in the world that have explored the effect of the perineal muscle training on the     avulsion of MEA.      Objective: To quantify the proportion of primiparous that result with avulsion of LAM after     their first birth among those performing perineal muscle training from week 33 of gestation     and those with usual prenatal care.   "
58989|NCT02513407|"     This randomized pilot research trial studies how well Eat, Move, Live (EML) works in reducing     chronic disease risk in medically vulnerable communities. Obesity, unhealthy diet, and     physical inactivity are linked to increased cancer risk, especially hormone-related cancer     (example, breast cancer). Improving healthy lifestyle practices, namely increasing physical     activity and encouraging healthy eating behaviors may reduce the risk of getting cancer and     chronic disease.   "
60075|NCT02499237|"     In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone     mineral density gains. The investigators aim to evaluate whether in patients treated with     denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.   "
58992|NCT02513368|"     The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at     implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance     the stability of peri implant soft tissue, when compared to the grafting technique (     bilaminar technique), performed in association with implant placement .   "
58993|NCT02513355|"     Research purpose:      Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination     chemotherapy regimens including cisplatin two medicine first-line treatment of advanced     non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.   "
58994|NCT02513342|"     Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection     pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance     treatment., and explore the predicted biomarkers.   "
58995|NCT02513329|"     Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact     their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic     women with breast cancer who are on anti-estrogens and are seeking relief from moderate to     very severe VMS that are adversely affecting health and wellbeing. Women with breast cancer     on Tamoxifen, aromatase inhibitors (AIs) or Selective Estrogen Receptor Modulators (SERMS)     with moderate to very severe VMS will be enrolled as participants in this study.   "
58996|NCT02513316|"     Study I: CROMIS-2 (AF) Prospective cohort study of patients anticoagulated after     cardioembolic stroke An observational inception cohort study (n=1425) of patients throughout     the United Kingdom (UK) - (79 hospitals) started on best practice oral anticoagulant (without     prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with follow up     for the occurrence of intracerebral haemorrhage (ICH) and ischaemic stroke for an average of     two years. The main baseline exposures (risk factors of interest) are the presence of     cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI), and genetic polymorphisms in     candidate genes with potential functional relevance to ICH risk.      Study II: CROMIS-2 (ICH) Observational and genetics study of intracerebral haemorrhage The     investigators will also recruit 600 patients admitted to participating centres with ICH (with     a target of at least 300 anticoagulant-related ICH cases) and collect DNA to increase the     power of the genetic studies. The investigators will collect clinical and imaging data from     these ICH cases to investigate risk factors associated with anticoagulant-related ICH     compared to non anticoagulant-related ICH.   "
58997|NCT02513303|"     The purpose of this study is to determine whether the use of the Sirolimus-eluting Collagen     Implant will improve AV Fistula outcomes, including time to first dialysis and suitability     for dialysis at 6 months, in subjects undergoing surgical creation of an AV fistula for     providing vascular access for hemodialysis.   "
58998|NCT02513290|"     The purpose of this study was to verify whether there were differences in health-related     quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to     those treated with loratadine 10 mg.   "
58999|NCT02513277|"     People with learning (intellectual) disabilities have more health problems than the rest of     the population; they are less likely to access help and have lifestyles that may increase     their risk of getting diabetes (for example, poor diet and lack of physical activity). People     with learning disabilities may also be prescribed drugs or have certain medical conditions     (such as Down's syndrome) which can make their chances of getting diabetes greater.      Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys, nerves     and feet. Impaired glucose regulation happens when sugar levels in the blood are higher than     normal but are not high enough to be diagnosed with diabetes. People with impaired glucose     regulation are more likely to develop diabetes, heart disease and stroke in the future. If     people with impaired glucose regulation make changes to their lifestyle (diet and exercise)     they can prevent or delay getting diabetes.      The aim of this study is to screen people with learning disabilities for diabetes and     impaired glucose regulation. The investigators also want to find out the best way to give     people with learning disabilities some education around healthy lifestyles (for example,     eating and exercise) to help with prevention of diabetes and cardiovascular disease.     Therefore, the investigators also aim to develop a lifestyle education programme that is     suitable for use in this population and test whether it is feasible and acceptable.   "
59000|NCT02513264|"     There is a need for people to take part in research studies to learn more about diseases and     how to treat them. The Registry for Asthma Characterization and Recruitment 2 (RACR2) will     create a database of participants with asthma and nasal allergies, or risk factors for these     conditions, who are potentially eligible for future Inner City Asthma Consortium (ICAC)     trials. The registry database will include assessments of various asthma and allergy     characteristics to achieve a more efficient, selective recruitment of these participants for     other protocols.   "
59001|NCT02513251|"     Pain is defined as An unpleasant sensory and emotional experience associated with actual or     potential tissue damage, or described in terms of such damage. In particular, chronic pain     has significant impact on health care cost and socio-economic aspects of the society. It is     clear that the development of effective chronic pain management is paramount in reducing the     significant socio-economic burden of this common healthcare problem.      One of the difficulties in measuring outcomes in chronic pain patients is the subjective     nature of pain. The McGill Pain Questionnaire (MPQ) was developed in 1975 with the aim of     quantifying the subjective pain experiences of patients. Since then it has become one of the     major assessment tools in evaluation of chronic pain patients during the course of     treatments. The Short Form McGill Pain Questionnaire (SF-MPQ) developed in 1987 has further     refined pain descriptors into sensory and affective domains, and incorporating the Visual     Analog Scale (VAS) for easier administration in hospitals and clinics. The validity and     reliability of both the original English and translated versions of MPQ and SF-MPQ have been     well demonstrated. The latest version of Short Form McGill Pain Questionnaire (SF-MPQ-2)     included descriptive terms for neuropathic pain which expanded the scope of coverage on     chronic neuropathic pain patients. It has also been evaluated in cancer pain patients.     Translated versions of SF-MPQ-2 showed good reliability and validity. Therefore the     investigators devised this study to (1) translate SF-MPQ-2 into Traditional Chinese-Cantonese     (C-SF-MPQ-2) suitable for use in Hong Kong patients, (2) examine the validity, reliability     and psychometric properties of this translated version in Hong Kong patients.   "
59002|NCT02513238|"     The current study aims to assess the safety and feasibility of the injection of autologous     adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia     in head and neck cancer participants. The project can potentially help to develop a     clinically relevant treatment option for the growing number of patients suffering from     xerostomia after radiotherapy. The development of new therapies is especially important,     since only sub-optimal symptomatic treatments are currently available and the symptom of     xerostomia greatly reduces the quality of life.   "
59012|NCT02513108|"     The purpose of this study is to provide information on safety of same day discharge after     uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian     clinical practice. The investigators also think that is in patients interest to stay as short     time as possible in hospital and this will be measured using standardised quality of life     questionnaires.   "
59003|NCT02513225|"     The goal of this research study is to evaluate the impact of a paraprofessional-delivered,     culturally adapted, evidence-based intervention (EBI) on sexually transmitted disease (STD),     substance use and poor mental/emotional health among American Indians (AI) through a     Randomized Controlled Trial (RCT). These intertwining risks have produced marked disparities     and have unique cultural and social determinants in Native communities. If aims are achieved,     scientific knowledge and community-based practice will be advanced in areas vital to AI     communities, and to STD and drug prevention science.      Prior to this study, the investigators applied findings from research protocol (IRB#00005929)     and adapted a brief intervention to reduce risk and increase protective behaviors for STDs,     HIV/AIDS, substance use and poor mental/emotional health, and to promote STD screening. The     specific aim of the current study is to compare the efficacy of the adapted brief     intervention vs. a comparison condition on participants' condom use, STD screening and     treatment-seeking behaviors, substance use and emotional/mental health outcomes at 3 and 6     months post-intervention.   "
59004|NCT02513212|"     This study will determine the effects toothbrush type (power or manual) has on the safety and     effectiveness of professional dentinal hypersensitivity treatment with a marketed     oxalate-containing solution.   "
59005|NCT02513199|"     The purpose of this study is to develop better ways to treat liver cancer, known as     hepatocellular carcinoma or HCC, while it is still in the liver. Many treatments exist to     treat tumors in the liver when they are small but after they grow past a certain size, local     therapies such as surgery, Trans-Arterial Chemo Embolization (TACE), or Radiofrequency     Ablation (RFA) are not effective. The purpose of this study to test the combination of two     known treatments - TACE and Stereotactic Body Radiation Therapy (SBRT) - to be used together     to treat larger or difficult to access liver tumors. Each treatment has been shown to work     well but has limitations. The study will combine the treatments in an organized sequence and     monitor closely how effective this combination controls tumors.   "
59006|NCT02513186|"     Primary Objective:        -  To determine the maximum tolerated dose (MTD) and recommended dose (RD) of isatuximab          when administered in combination with bortezomib, cyclophosphamide, and dexamethasone          (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly          diagnosed multiple myeloma non-eligible for transplantation.        -  To evaluate safety and preliminary efficacy (overall response rate, complete response          rate and duration of response) of isatuximab in combination with 2 bortezomib-based          regimens (VCDI and isatuximab with bortezomib, dexamethasone, and lenalidomide VRDI).      Secondary Objectives:        -  To characterize the overall safety profile of isatuximab in combination with each          bortezomib-based regimen, including cumulative toxicities.        -  To characterize the pharmacokinetic (PK) profile of isatuximab and each combination drug          in each isatuximab/bortezomib-based regimen.        -  To evaluate the immunogenicity of isatuximab in combination treatments.        -  To evaluate the preliminary efficacy of both bortezomib-based regimens in terms of          duration of response and overall survival.        -  To assess the relationship between clinical effects (adverse event [AE] and/or tumor          response) and CD38 receptor density.   "
59007|NCT02513173|"     Segmental stabilization exercise has been shown to be effective in the rehabilitation of low     back pain (LBP). Due to the isometric nature of segmental stabilization exercise, manual     therapists use various verbal instructions to elicit lumbar multifidus muscle contraction.     The purpose of this study was to assess whether or not three verbal instructions would alter     muscle thickness of the lumbar multifidus differently in asymptomatic individuals and     patients with LBP.      Three verbal instructions were selected for this study: (1) swell the muscle underneath the     transducer, (2) draw your belly button in towards your spinal column, and (3) think about     tilting your pelvis but without really doing it. Lumbar multifidus muscle thickness was     determined using parasagittal ultrasound imaging. Measurements of muscle thickness were     collected at rest and during verbal instructions from 21 asymptomatic adults and 21 patients     with LBP. Percent changes of muscle thickness during contraction and at rest were compared     between groups and across verbal instructions.   "
59008|NCT02513160|"     The primary objective of this study is to evaluate the efficacy of beclomethasone     dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320     or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent     asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and     pre-rescue bronchodilator) Forced expiratory volume in 1 second (FEV1) area under the effect     curve from time 0 to 6 weeks (AUEC[0-6wk]).   "
59009|NCT02513147|"     The purpose of this study is to assess changes in viral reservoir after changing IP/r to     dolutegravir in HIV-1 infected patients maintaining undetectable viral load on Antiretroviral     Therapy (ART).   "
59010|NCT02513134|"     Recently a prototype of a combination of an anterior segment OCT (VISANTE; Carl Zeiss Meditec     AG) and an operating microscope (OPMI 200; Carl Zeiss Meditec AG) was introduced that allows     measurements of the crystalline lens as well as the lens capsule itself after removing the     crystalline lens of cataract patients intra-operatively. This device uses OCT technology to     create high resolution B-scans (=images) of the anterior segment of the eye. The OCT was     shown to be highly reproducible for ACD measurements pre-operatively 12 and small changes of     the IOL/crystalline lens can be detected 13.      In a previous study (EK-10-125-0710) that was recently published in the journal     Investigative Ophthalmology & Visual Science it was shown that intra-operative measurements     of the anterior lens capsule improve the refractive outcome theoretically.14 However, in this     previous study conventional eye models were used for IOL power calculation and only the     intra-operative measurement replaced pre-operative ACD measurements.      Aim of this study is to observe, whether the postoperative refractive outcome could be     improved theoretically by using both pre- and intra-operative measurements for retrospective     IOL power calculation with new eye models.   "
59011|NCT02513121|"     This is an investigator initiated study being conducted in equal numbers at two sites, UC San     Diego and Emory University. The purpose of this study is to understand the potential of a low     sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children. Forty     boys with NAFLD will be randomly assigned to either an intervention group or a habitual diet     control group. The intervention will be a low sugar diet for a period of 8 weeks. The effect     of this dietary change will be assessed using advanced MRI testing to measure liver fat.   "
59013|NCT02513095|"     Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study     of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered     intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is     defined as effective body cooling, which should be implemented as quickly as available after     diagnosis of exertional heat stroke.   "
59014|NCT02513082|"     This study aims to compare the effectiveness of adductor canal block and femoral nerve block     in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and     effective in pain control after total knee arthroplasty. But some authors insist that     quadriceps muscle power was decreased by femoral nerve block. The study design is a     double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously     bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve     block on one leg and adductor canal block on the other, in addition to combined general     anaesthesia. The primary outcome was comparative postoperative pain in either extremity at     four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes     included motor strength by cybex test.   "
59015|NCT02513069|"     The primary goal of the study is to evaluate the effectiveness of a combined tele-health and     contingency management (CM) intervention that the investigators call mobile CM, or mCM, in     promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile     system to reward non-smoking, smoking cessation counseling, and smoking cessation     medications. The primary aim is to evaluate how effective this intervention is in promoting     smoking abstinence compared to telehealth interventions for smoking cessation.   "
59016|NCT02513056|"     The overall objective of this protocol is to evaluate the safety and utility of diagnostic     MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and     Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI.   "
59017|NCT02513043|"     This pilot study is designed to obtain preliminary data on the safety, acceptability, and     feasibility of direct-to-consumer telemedicine abortion.   "
59018|NCT02513030|"     The SIMPLE study was a large one, and lasted quite a few years due to its design as a     randomized controlled trial and the follow up needed to reach an endpoint. The investigators     aim to conduct an observational pilot study looking at frequency of positive findings during     VF testing . The comparator will be the rate of findings during testing in the Simple trial.     If the investigators will find an increased rate of findings (significantly higher than in     the Simple trial ) it may set the stage for a randomized controlled trial of replacements ,     along the line of the Simple trial , or to a recommendation to continue VF testing in all ICD     replacements.   "
59019|NCT02513017|"     Research has shown that persons who have trouble sleeping and experience stress are at risk     of developing heart diseases. Two treatments, called stimulus control instructions and sleep     efficiency treatment, that do not involve sleeping pills, have been found effective in     managing trouble sleeping. This study will be undertaken to find out if the two treatments     are effective in improving sleep, and reducing stress and the risk of heart diseases. Persons     with trouble sleeping may have a preference for either treatment. It is believed that if     persons get the treatment they prefer, then they will be satisfied with the treatment and     comply with it, and experience improvement in their sleep. This study will also examine the     extent to which giving persons the treatment of their choice, as compared to giving persons     treatment based on chance, will lead to higher satisfaction and compliance with treatment,     and improved sleep. About 300 persons who experience trouble sleeping will be included in the     study. They will be requested to complete a questionnaire and a sleep diary before and after     they receive treatment, as well as 6 month and one year later.   "
59020|NCT02513004|"     This study is designed to test the hypothesis that the onset of the antiplatelet effect     90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of     clopidogrel evaluated by P2Y12 reaction units measured by Verify NowTM P2Y12 assay at 1 hour     in patients undergoing one-stop Hybrid coronary revascularization(HCR).   "
59021|NCT02512991|"     This study compares patients bound for Percutaneous Coronary Intervention (PCI) who were     transported by either ground ambulance or emergency medical helicopter. The investigators     describe long-term follow-up in relation to mortality and labour affiliation.   "
59022|NCT02512978|"     Based on accumulating evidences showing that hypothyroid status is associated with poor     prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate     whether replacement treatment with levothyroxine could have beneficial effects on patients     with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial     stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy     group.   "
59023|NCT02512965|"     The purpose of this study is to find out if SBRT is better than CRT at controlling pain in     the spine 3 months after receiving treatment.   "
59024|NCT02512952|"     Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along     with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in     the treatment of intrabony defects (IBDs).      Materials and methods: Study was conducted on subjects reporting to the Department of     Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90     periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone     (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each     subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm     in at least three teeth.   "
59026|NCT02512926|"     This study evaluates the use of carfilzomib in combination with cyclophosphamide and     etoposide for children with relapsed/refractory solid tumors or leukemia. The medications     cyclophosphamide and etoposide are standard drugs often used together for the treatment of     cancer in children with solid tumors or leukemia.      Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults     with multiple myeloma (a type of cancer). However, this drug is not approved for the disease     being treated in this study. Since carfilzomib has not yet been used in this setting to treat     this condition, the investigators must first find the best dose to give. The investigators     are looking for the highest dose of carfilzomib that can be given safely. Therefore, not all     children taking part in this study will receive the same dose of the study drug in the first     part of the trial.   "
59029|NCT02512887|"     Hypospadias is one of the most common congenital malformations of the genitalia in boys, and     is typically managed by surgical intervention. During pediatric urological surgery, caudal     anesthesia is one of the most common regional anesthetic techniques used. Also known as     caudal block, it has been shown to be a safe and effective anesthetic technique in children     with a low incidence of anesthesia-related complications.While the reported incidence of     complications directly associated with caudal block is low, there is scarce and inconclusive     evidence on the impact of caudal anesthesia on the incidence of surgical complications. As a     result, the objective of this superiority, randomized controlled trial is to assess whether     the use of caudal anesthesia, when compared to dorsal penile block, is associated with a     higher rate of urethrocutaneous fistulas and glans dehiscence post hypospadias repair.   "
59030|NCT02512874|"     Frailty is a state of health with predisposition to adverse events, morbidity and mortality.     Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting.     Frailty is associated with increased hospitalizations and death in lung disease. It is     unknown if pulmonary rehabilitation will improve frailty markers.   "
59031|NCT02512861|"     All pediatric patients who undergo cardiac surgery require analgesic medications for     postoperative pain control and many require sedation to facilitate comfort with cares.     Parasternal infiltration of local anesthetic for nerve blocks is a simple option to     postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve     block administered in pediatric patients undergoing cardiac surgery will reduce the     requirement of Opioids and other pain medications as well as decrease postoperative pain     scores. This is a prospective, double-blind, randomized controlled trial. Subjects are     randomized to receive either 0.25% Bupivacaine or normal saline following their     cardiothoracic surgery.   "
59032|NCT02512848|"     Investigators aim to collect endometrial sampling with Li Brush among target population who     have risks for endometrial neoplasm, then Fractional curettage should performed with these     participants, investigators intend to compare the pathological diagnosis results of cytology     and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect     that the brush can be used for screening of endometrial cancer in the postmenopausal period     in the clinic.   "
59033|NCT02512835|"     Social determinants of health (e.g. the income, education, and environment of patients) may     exert greater influence on health outcomes than traditional clinical factors (e.g. lab     results, diagnoses, and family history). Calls for integrating primary care and public health     are therefore increasing, but merging these domains of care is logistically difficult.     Research is lacking on the incremental benefit of adding public health data at the practice     level-- in improving either health outcomes or care delivery. This proof of concept pilot     will merge data from electronic health records (EHRs) with community vital signs, a set of     metrics that describes key community resources that affect health. The investigators will     identify resource poor communities, or cold spots, based on four variables (education,     poverty, life expectancy, and access to healthy foods) at the census tract level - referred     to as a community vital sign. The hypothesis is that patients coming from cold spots are more     likely to have worse health outcomes and that clinicians will deliver better care if they     know a patient's community context and his/her specific social needs. This study will involve     12 primary care practices in Northern Virginia that care for more than 170,000 patients.     Patient addresses will be geocoded for each practice and determine which patients reside in     cold spots for each community vital sign. The variation for each community vital sign for     each practice's patients will be calculated and a bivariate and regression analyses will be     used to determine whether coming from a cold spot is associated with worse clinical quality     metrics. 15 clinicians will be alerted when they see a patient from a cold spot, patients     will complete a social needs survey, and clinicians will prospectively document through     surveys whether such knowledge affects interpersonal interactions (such as time spent with     patients and the use of clearer language) or clinical management (such as referrals to care     coordination or community resources). By pragmatically integrating community vital signs into     care, this innovative proposal will seek to understand which community data clinicians value,     how these data might influence care, and how best to incorporate these data into clinical and     population care.   "
59034|NCT02512822|"     To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.   "
59035|NCT02512809|"     The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and     serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement     under isoflurane anesthesia.   "
59036|NCT02512796|"     Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known     of its toxicity outside of patients with reduced renal function.   "
59037|NCT02512783|"     This is a double blind, randomized, controlled study. The sedationist performing the sedation     procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo     before the administration of Propofol. A research staff will observe the patient     simultaneously with the induction of Propofol to determine the patient's pain level, as     measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this     study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the     burning sensation caused by intravenous Propofol.   "
59038|NCT02512770|"     The aim of this study compares hemodynamic and respiratory changes and complications in     children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only     control.   "
59039|NCT02512757|"     This is a prospective, multi-center study to evaluate the diagnostic performance     characteristics of the AminoIndex™ technology among patients at high risk for developing lung     cancer as compared with standard lung cancer screening and diagnostic procedures including     low-dose CT, high-dose CT, biopsy and histopathology.   "
59040|NCT02512744|"     Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing     two different decannulation protocols:        1. based on capping trials to decide decannulation,        2. based on the aspiration frequency to decide decannulation time. High-flow conditioned          oxygen therapy will be applied to all patients through the tracheal cannula. In patients          included in the suctioning frequency based protocol along the study period and in          patients included in the capping trial protocol along periods out of capping trials.   "
59041|NCT02512731|"     Delayed graft function (DGF) is defined as requirement for dialysis in the first week     following kidney transplantation. DGF is a common complication occurring in 39% of the     deceased donor renal transplants at the investigators' institution with significant cost and     outcome implications. The 3 major risk factors for DGF are donor graft characteristics,     recipient factors and perioperative management. The most easily modifiable of these factors     is perioperative management, in particular intraoperative fluid therapy. The investigators     propose to compare the amount of fluid administered using the current standard of care with     the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler     Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta,     optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid administration     fails to produce an increase in CO.   "
59042|NCT02512718|"     Children undergoing hematopoietic cell transplantation (HCT) for cancer or blood disorders     frequently develop gastrointestinal, metabolic and infectious complications related to     preparative high-dose chemotherapy and/or radiation-related toxicity. Parenteral nutrition     (PN) with lipid emulsion is commonly required while gastrointestinal complications preclude     adequate oral or enteral intake. PN and lipids may increase the risk of metabolic and     infectious complications in HCT patients who are inherently immune compromised.      Supplementation with omega-3 fatty acids has been linked to improvements in outcomes in     several populations. Provision of fish oil lipid emulsion (FOLE), rich in omega-3 fatty     acids, to children undergoing HCT is an innovative nutritional strategy that could mitigate     the metabolic and inflammatory side effects of HCT and its treatment. With its potential to     safely maintain essential fatty acid status, normalize blood lipids and alleviate the     inflammatory response to illness, the use of FOLE may reduce the risk of infections,     regimen-related toxicity, and other morbidities after HCT.      A randomized, controlled pilot study is proposed to test the safety and tolerability of FOLE,     compared to standard lipid emulsion, in 20 children during hospitalization for HCT. Results     of this study will provide the preliminary data needed for a larger clinical trial examining     the effect of FOLE on important clinical outcomes in this population. This novel approach to     nutritional care of this high-risk group will advance clinical knowledge of the impact of     FOLE, and will support further investigation into nutritional adjuncts to pediatric cancer     treatment.   "
59043|NCT02512705|"     The Psychiatric Emergency Services (PES) is an under researched area of clinical practice,     largely in the management of acutely agitated and violent patients. The goal of this pilot     randomized clinical trial (RCT) is to assess the benefit of medically monitoring patients     that present with extreme agitation and/or violent behaviour to PES. Placing them in physical     restraints and immediately administering chemical restraint, will enable medical monitoring     of these potentially medically unstable patients. Investigators believe that this practice     will provide safer management of patients, reduce risk to staff and other patients, reduce     risk of undiagnosed medical conditions that underly the agitation, and increase clinical     management and quality of care. Patients that come into the Emergency Department that are     agitated and violent, where verbal-deescalation will not suffice, will be randomly treated     with either immediate placement in seclusion (current practice) or be placed in physical     restraints and given chemical restraint (as outlined in the BETA project guidelines). The     same time interval assessments will be performed on both groups of patients including;     medical monitoring and agitation scale assessment. Data will also be collected on number of     violent episodes, code whites, required increase in the use of physical restraints, length of     intervention, and more. This assessment will enable a comparison between the current practice     and the proposed practice to establish evidence based clinical guidelines for the management     of acute agitation in PES, where de-escalation techniques are ineffective and the lack of     medical monitoring is harmful to the patient and can negatively effect their outcome. In     order to best assess the importance of medical monitoring for such patients, a pilot study     must be performed to assess the feasibility of such a phase III RCT study.   "
59044|NCT02512692|"     The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y     TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable     intrahepatic cholangiocarcinoma (ICC).   "
59045|NCT02512679|"     Many genetic diseases of lymphohematopoietic cells (such as sickle cell anemia, thalassemia,     Diamond-Blackfan anemia, Combined Immune Deficiency (CID), Wiskott-Aldrich syndrome, chronic     granulomatous disease, X-linked lymphoproliferative disease, and metabolic diseases affecting     hematopoiesis) are sublethal diseases caused by mutations that adversely affect the     development or function of different types of blood cells. Although pathophysiologically     diverse, these genetic diseases share a similar clinical course of significant progressive     morbidity, overall poor quality of life, and ultimate death from complications of the disease     or its palliative treatment. Supportive care for these diseases includes chronic transfusion,     iron chelation, and surgery (splenectomy or cholecystectomy) for the hemoglobinopathies;     prophylactic antibiotics, intravenous immunoglobulin, and immunomodulator therapies for the     immune deficiencies; and enzyme replacement injections and dietary restriction for some of     the metabolic diseases. The suboptimal results of such supportive care measures have led to     efforts to implement more aggressive therapeutic interventions to cure these     lymphohematopoietic diseases. The most logical strategies for cure of these diseases have     been either replacement of the patient's own hematopoietic stem cells (HSC) with those     derived from a normal donor allogeneic bone marrow transplant (BMT) or hematopoietic stem     cell transplant (HSCT), or to genetically modify the patient's own stem cells to replace the     defective gene (gene therapy).   "
59046|NCT02512666|"     This research study is looking at a small device that measures white blood cell (WBC) counts     by being placed against the finger nail for participants who are undergoing stem cell     transplantation at Massachusetts General Hospital or have a hematologic malignancy and are     being seen as an outpatient.   "
59047|NCT02512653|"     Biological Standardization of Cupressus arizonica Allergen Extract.   "
59062|NCT02512458|"     This is a prospective, open-label, single arm translational study of cabazitaxel in bone     Castration Resistant metastatic Pancreatic Cancer (mCRPC) patients. Patient will be treated     with intravenous (iv) cabazitaxel 25mg/m2 every (q) 21days per standard clinical practice for     up to 10 cycles or until disease progression or unacceptable toxicity or physician's decision     or patient's consent withdrawal (whichever occurs first).   "
59048|NCT02512640|"     Ischemia-reperfusion injury resulted from pneumoperitoneum during laparoscopic surgery have     been reported in some literatures. There are no studies investigating the time course of     changes in oxidative stress markers in volume-controlled ventilation (VCV) and     pressure-controlled ventilation (PCV) modes. The aim of this study is to compare the     alterations in oxidative stress in two different ventilation strategies during gynecologic     laparoscopic surgery.      Methods:      Fifty-two patients of ASA physical status I or II were randomly assigned to receive either     VCV or PCV during laparoscopic gynecologic surgery. Blood gas analysis and ventilation     variables were recorded 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum. Blood     samples for malondialdehyde (MDA) measurement were collected at seven points: 1 minute before     (T1) and 1 hour after (T2) pneumoperitoneum; 30 minutes, 60 minutes, 90 minutes, and 120     minutes after deflation (T3~T6); and 24 hours after deflation (T7).   "
59049|NCT02512627|"     This study aims to investigate and compare the intervention effects of combining exercise and     cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly     with mild cognitive impairment. The investigators hypothesize that (1) both sequential and     dual-task training can induce greater improvements in the outcome measures than single mode     of training; (2) the improvement in cognitive functions and other outcomes may differ between     the groups.   "
59129|NCT02511587|"     FSME-Immun® is registered for application into the muscle. This study investigates if     application under the skin leads to a comparable immune response.   "
59050|NCT02512614|"     In March 2012, the investigators initiated a prospective, cluster-randomized, controlled     field trial in Kisumu County, located in an area in western Kenya which has the highest     under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The     study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter     referred to as towel) in preventing diarrheal diseases, acute respiratory infections,     self-reported fever, and skin infections in children <2 years old.   "
59052|NCT02512588|"     This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple     crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without     cataplexy (Type 2).   "
59053|NCT02512575|"     This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single     ascending dose sequential group study in healthy male subjects. The objectives are to study     the safety, tolerability, pharmacokinetics and effects on glucose homeostasis     (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid     receptor modulator (SGRM). The study will also assess the safety, tolerability,     pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high     doses of AZD9567 and placebo.   "
59054|NCT02512562|"     This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and     Simeprevir on AL-335 pharmacokinetics in healthy volunteers.   "
59055|NCT02512549|"     This study is a randomized parallel group controlled trial which aims to study the effects of     pulmonary rehabilitation intervention on exercise capacity and quality of life in patients     with severe COPD as compared to standard medical care. The expected duration is one and a     half years with effect from 1st July, 2015 and will include 80 patients, 40 in each arm.   "
59056|NCT02512536|"     Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen     both in primary and secondary care. It is a painful condition, with significant disability.     Specialist shoulder replacements have found acceptance within the trust, nationally and     internationally although there are high complication rates. There is however a significant     cost difference (fifty fold) between a reverse total shoulder replacement and a botox     injection, and to date there have been no randomised control trials, or any registered,     comparing the use of a botox injection for pain relief in cuff arthropathy versus no     treatment. If there is a significant clinical difference in the pain outcomes between the     two, this could result in significant savings to the NHS and the taxpayer as a whole. If high     levels of pain relief could be predictably obtained using Botulinum A toxin injections then     potentially patients could avoid the need for surgery.   "
59057|NCT02512523|"     This is a randomized, double-blind, active control, parallel group, exploratory phase 4 study     to compare the effect of teneligliptin versus sitagliptin on glucose variability when added     on to metformin in patients with inadequately controlled type 2 diabetes mellitus.   "
59058|NCT02512510|"     The purpose of this study is to measure the effectiveness and safety of TD 4208, an     investigational drug being developed to treat people with moderate to very severe COPD,     compared to placebo, a treatment without activity.   "
59059|NCT02512497|"     The goal of this clinical research study is to learn if giving romidepsin before and after a     stem cell transplant in combination with fludarabine and busulfan can help to control     leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin     that can be given with this combination.      The safety of this combination and the safety of giving romidepsin after a stem cell     transplant will also be studied.   "
59060|NCT02512484|"     Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not     have a general practitioner (GP) registration and their only interaction with the NHS is via     Accident and Emergency (A&E) Departments of hospitals. This is often the case for those in     hard to reach groups, who are also those often at highest risk of TB. This study seeks to     assess whether A&E Departments are effective sites for the identification and onward     management of TB, both in its latent and active forms.   "
59061|NCT02512471|"     The aim of this study is to determine the minimum effective volume of local anesthetic     (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for     surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle     aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal     to the shoulder.   "
59065|NCT02512419|"     The aim of this study is to build upon our tailored print intervention by developing new     text-delivered intervention materials to complement our print-based physical activity (PA)     intervention. In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American     (MA) men to determine content, frequency, and types of text messages desired, and to identify     cultural themes to incorporate into existing and new materials. Themes from the focus groups     and sample text messages will be presented to a confirmatory focus group panel. Phase 2 will     be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60) to test the     text-enhanced, Spanish language, individually tailored PA intervention vs. publicly     available, Spanish language health education materials, including information on PA, diet,     and stress management. This will be followed by post-intervention qualitative interviews to     solicit suggestions for improvements to help further refine the program. The proposed pilot     will support a future R01 to establish the efficacy of this multi-media, multi-level PA     intervention for Mexican and MA men.   "
59066|NCT02512406|"     The purpose of this study is to learn more about how patients with Tourette Syndrome deal     with sensory stimuli in their environment such as bright lights, loud noises, physical     sensations such as shirt tags, etcetera. We will compare responses of patients with Tourette     Syndrome to those without Tourette Syndrome.      The study aims to better characterize sensory processing abnormalities by sensory modality:     The investigators will use a measuring tool based on Dunn's 1997 model of sensory processing,     the Sensory Profile, which will allow the investigator to characterize both registration and     response to external stimuli, as well as to delineate which sensory modalities are affected.     Identifying which sensory modalities are most affected may guide future research into the     pathophysiology of sensory processing abnormalities in TS.      The investigators also aim to correlate sensory processing abnormalities with the presence of     Obsessive Compulsive Disorder (OCD), Attention-deficit/hyperactivity disorder (ADHD) , and     autism spectrum disorders.   "
59067|NCT02512393|"     The purpose of this research is to study the effects of Transcranial Direct Current     Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a     better understanding of the factors that cause pain and disability in people with knee     osteoarthritis (OA). In particular, people from different ethnic and racial groups may     experience OA pain differently which is why the focus will be on older Asian Americans and     non-Hispanic whites. It is important to find a reason for such difference so that a better     treatment can be found for all OA patients. In addition, the research study will examine if     there is any ethnic differences in pain and mobility disability. The investigator hypothesize     that Asian Americans will report greater pain and mobility disability than non-Hispanic     whites, and that active tDCS will result in improvement in pain and disability compared to     sham tDCS.   "
59068|NCT02512380|"     gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of     this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel     (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable     gastric/esophagogastric junction (EGJ) cancer.   "
59069|NCT02512367|"     There are few disease prevention programs or programs to manage somatic disorders in a     psychiatric context. The aim of this study is to evaluate the impact in the medium term of a     global program to promote dental health on buccodental hygiene in patients with schizophrenia     and the ability of these patients to follow the intervention.      This is an interventional trial, randomized in clusters. The participating establishments     will be randomized to the intervention group (promotion program) or the control group     (surveillance).      For each patient, the study will last 12 months altogether and will include an initial     evaluation of dental health, a 6-month education program for dental care (for patients in the     intervention group) and a follow-up at 6 and 12 months after the start of the study. The     follow-up will evaluate dental health and quality of life.   "
59070|NCT02512354|"     This research concerns the contribution of a new examination, high-throughput exome     sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. With currently     available examinations, the causes of polyformative syndromes, which correspond to the     association of several congenital malformations with varying degrees of severity in different     organs, remain unknown in a large number of cases.      High-throughput exome sequencing (HTES) is a diagnostic tool that allows the simultaneous     analysis of all of the coding parts of DNA. This examination has already shown its superior     diagnostic capability in every post-natal diagnostic context, in particulier in infants with     malformations associated or not with intellectual deficiency. Its contribution has not yet     been studied in a large number of fetuses with polymalformations. To investigate the     usefulness of HTES, we propose to carry out the examination in 100 fetuses with     polymalformations, as well as the usual examinations including chromosomal microarray     analysis and possibly the study of specific genes that may explain these malformations. A     blood sample will be taken from both parents to allow interpretation of the results.   "
59071|NCT02512341|"     The purpose of this preliminary clinical study is to assess the quality of a computational     algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either     pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.      Each patient is auscultated and diagnosed independently by a medical specialist by means of a     standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a     Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An     echocardiogram is performed as the gold-standard for determining heart pathologies. The     results of the computer aided auscultation (CAA) are compared to the findings of the medical     professionals as well as to the echocardiogram findings.      Hypothesis: The specific CAA algorithms used in this study are able to differentiate     pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric     population.   "
59072|NCT02512328|"     Feasibility of an newly programmed offline application for smartphones (SPA, APP) for     colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and     behavioral recommendation.   "
59119|NCT02511717|"     Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence.     This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin     patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the     treatment of women with clinical symptoms of overactive bladder.   "
59073|NCT02512315|"     The standard treatment strategy of locally advanced nasopharyngeal carcinoma (NPC) nowadays     is concurrent chemoradiation (CRT) based on intensity-modulated radiation therapy (IMRT).     However, distant metastasis remains the major cause of treatment failure, especially in     patients with T1-4N2-3M0 diseases (N2-3 NPC). The investigators inferred that it was more     appropriate to consider N2-3 NPC as a systemic disease instead of a local disease. NACT of     sufficient intensity such as 4 cycles might be effective enough for control of the     pre-existing micrometastases. Therefore, the objective of this phase 3 multicenter randomized     controlled trial is to make a comparison between NACT of 4 cycles plus CRT based on IMRT and     CRT alone in N2-3 NPC on distant metastasis, survival and adverse reaction.   "
59074|NCT02512302|"     The purpose of this research study is to determine the amount of medicine absorbed in the     lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated     charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).   "
59075|NCT02512289|"     tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used     in chronic stroke patients to improve a variety of functions with upper limb.   "
59076|NCT02512276|"     The purpose of this cluster randomized controlled trial is to evaluate whether a novel     tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and     diabetes improves medication adherence, disease control, and patients' understanding of their     treatment.   "
59077|NCT02512263|"     The purpose is to assess the adherence and the efficiency of a home-based training program on     muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and     depression for colon cancer patient treated by chemotherapy.   "
59078|NCT02512250|"     The Swiss Hemophilia Registry will collect data on the prophylactic and therapeutic use of     factor concentrates in patients with hemophilia and other severe bleeding disorders in     Switzerland.   "
59079|NCT02512237|"     This is a 2-part, Phase 1 FIH study with Phase 1a designed to determine the maximum tolerated     dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic cancers with a human     epidermal growth factor receptor 2 (HER2) test result that is in situ hybridization (ISH)     positive (+) or immunohistochemistry (IHC) 3+ or 2+, and Phase 1b designed to assess     anticancer activity and safety in three expansion cohorts: two different advanced breast     cancer expansion cohorts (namely, for tumors that test as HER2 ISH positive or IHC3+ and for     tumors that test as HER2 ISH negative with IHC 2+), and one advanced gastric cancer expansion     cohort (for tumors that test as HER2 ISH positive or IHC3+).   "
59080|NCT02512224|"     Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally     were compared and analyzed.   "
59081|NCT02512211|"     Spanish Validation of HAL and HEP questionnaire by double translation     (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and     parents of children with hemophilia. The final validity will be obtained with a sample of     60-100 patients with hemophilia   "
59082|NCT02512198|"     This is a randomised controlled study to evaluate the effect of providing prescribing     feedback that includes individual patient data to General Practitioners (GP) in Scotland on     high risk or low quality prescribing.   "
59083|NCT02512185|"     This study will examine the impact of modern treatments for metastatic Castrate Resistant     Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function,     objective physical function, and falls. Additionally, the investigators study whether frailty     is associated with worse outcomes, and whether it is possible to predict the risk of severe     chemotherapy toxicity in older men.   "
59084|NCT02512172|"     This study is being done to test the safety and effectiveness of the combination of     intravenous (IV) romidepsin and/or oral 5-azacitidine with IV MK-3475 in people with     microsatellite stable (MSS) advanced colorectal cancer.   "
59085|NCT02512159|"     The aim of this study was to evaluate the efficacy of a handicraft topical device of negative     pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients     with diabetes mellitus, venous stasis and arterial insufficiency.   "
59086|NCT02512146|"     The study aims to determine the expression of the ionotropic glutamate receptors in colon of     irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic     glutamate receptors and IBS symptoms.   "
59087|NCT02512133|"     To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of     microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus     (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary     open angle glaucoma (POAG).   "
59088|NCT02512120|"     Volume controlled ventilation(VCV) is a most common used ventilation mode during general     anesthesia. But VCV can cause high airway peak pressure when patient under steep     Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure     and improve dynamic compliance. We will compare parameters(arterial blood gas analysis,     airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.   "
59089|NCT02512107|"     The purpose of this study is to determine if a dried fruit and vegetable supplement (Juice     Plus+) can alter the gut microbiome and improve gut permeability and inflammatory levels in     an obese, stressed population.      The microbiome and its component genes are long known as critical determinants of the     nutritional value of the food we eat. Recently, it has become clear that the composition of     this microbiome and its metabolites influences the host immune system, thereby altering host     physiology. Both obesity and chronic stress have been shown to have an altered gut     microbiome; both these conditions also lead to increased systemic inflammatory molecules that     can lead to an increased risk for type 2 diabetes and other diseases caused by chronic     inflammation.      Juice Plus+ consumed by an overweight population combined with an eight week exercise regime     showed decreased markers of protein/lipid oxidation (ox-LDL), total lipid oxidation (TOS) and     lowered systemic concentrations of the inflammatory cytokine, TNF-α. As systemic cytokines     are altered by the composition of the gut microbiome, this study proposes to determine if     this decrease in inflammation by Juice Plus+ is due to a change in the species composition     and metabolism of the microbiome. This question is particularly relevant for populations with     high inflammatory loads resulting from excess weight in addition to increased psychological     stress.      The investigators propose to determine 1) how Juice Plus+ consumption alters the microbiome     species composition and metabolism, 2) if there is an alteration in intestinal permeability     with the consumption of Juice Plus+ and 3) do these alterations coincide with lower systemic     markers of inflammation and oxidative stress among individuals who are psychologically     stressed and overweight. The investigators will use a randomized, placebo-controlled design     with a cohort of overweight, female, critical care health care professionals. Subjects will     receive the supplements or placebo for sixteen weeks. At the end of 16 weeks, the cohort     receiving the supplement will be randomized to also receive a meal replacement component or     follow their normal diet for an additional 4 weeks. Stool and a fasting blood sample will be     collected at the beginning of the study (baseline) and 8, 16 and 20 weeks later. At each time     point, subjects will also consume a cocktail of glucose, mannitol and lactulose and a second     blood draw performed to look at absorption of these molecules.   "
59090|NCT02512094|"     Since an increasing in population age, there was an increasing in geriatric patients. Most of     elderly patients needed rehabilitation programs to regain their quality of life during their     medical treatments. Barthel index is a functional measurement to evaluate rehabilitation     improvement in chronically-ill patients and also used for evaluation of patient's self-care.      Barthel index had been translated into many languages and validated in many medical     conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However,     Barthel index had not been translated into Thai language and validated to use in hip fracture     patients.      The purposes of this study were to translate the Barthel index into Thai language and to     assess validity and reliability of Thai version Barthel index in hip fracture patients.   "
59091|NCT02512081|"     This will be an exploratory study, using semi-structured interviews to explore patients'     experiences of undergoing investigations for Sciatica (leg pain referred from the lower     back). Interviews will be analysed based on an Interpretative Phenomenological Approach     (IPA).The end product of analysis will be a detailed account of patients' experiences     supported by direct quotes.The intention is that this account will help health-care providers     to understand patients' experiences and to plan and provide Sciatica care that is effective,     evidence based and acceptable to patients.   "
59092|NCT02512068|"     The purpose of this study is to evaluate the efficacy and safety of SYR-472 when administered     at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes     mellitus complicated by severe renal impairment or end-stage renal failure and inadequate     glycemic control despite diet and/or exercise therapy (if given) or despite treatment with     one other antidiabetic drug in addition to diet and/or exercise therapy (if given); and to     evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 25 mg     once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment     or end-stage renal failure.   "
59093|NCT02512055|"     Ketamine provides a safety zone for sedated but spontaneously ventilated children especially     in remote conditions such as radiotherapy units where sedation is an essential practice for     children to keep calm and motionless In this study, investigators planned to analyse ketamine     doses needed and the recovery times in pediatric oncology patients undergoing repeated     radiotherapy sessions.   "
59094|NCT02512042|"     This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence     study, at multiple clinical trial sites designed to demonstrate bioequivalence of     Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma     Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in     the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.   "
59095|NCT02512029|"     This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute     traumatic brain injury.   "
59096|NCT02512016|"     The Motherhood and Pelvic health study (MAP), Bridging physical and cultural determinants of     postpartum pelvic floor support and symptoms following vaginal delivery, uses mixed methods     research to study the influences of intra-abdominal pressure, physical activity and strength     on pelvic floor support and symptoms and the cultural context in which women experience those     changes.   "
59097|NCT02512003|"     The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary     Scaffold in native coronary arteries.   "
59098|NCT02511990|"     This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the     antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in     HIV-infected and HIV-uninfected individuals.   "
59099|NCT02511977|"     The control of biofilm around implants is critical to the success of the implant     rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform     and guide patients, and keep their maintenance in order to prevent pathological processes     that can lead to the implanted component loss.The aim of the present retrospective     longitudinal study was to evaluate through clinical periodontal parameters and radiographic     images in dental implants rehabilitated with overdentures installed seven years ago.     individuals who underwent the installation of dental implants for making full     implant-supported upper and lower mucus dentures in the Department of Implant Dentistry,     Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal     parameters such as probing depth, plaque index, bleeding index and mobility as well as     radiographic examination, are key to determine the correct diagnosis in dental implants. The     control of biofilm around the implants seems to be a decisive factor for maintaining tissue     health. We believe that the maintenance appointments are fundamental, but more studies should     be conducted to elucidate microbial and immunological factors in implants placed and due for     some time.   "
59100|NCT02511964|"     The objective was to determine the effect of six running sessions of high intensity interval     training (HIIT) at 1% and 10% incline on VO2max, peak of velocity (VPeak), and time limit of     1% (TLim1%) and 10% (TLim10%) of inclination, as well as the influence of the specificity of     training on performance in the different inclines.   "
59101|NCT02511951|"     The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure     named One-layer duct-to-mucosa pancreaticojejunostomy in pancreatoduodenectomy, which could     provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.   "
59102|NCT02511938|"     This study will introduce healthy child menu items into 8 independent full service     restaurants in San Diego County. The restaurants will be assigned either to receive new,     healthy kids' menu items or to receive the new menu items in addition to marketing materials     and staff trainings to support promotion of these new menu items. The primary outcome for the     study is sales of kids' menu items. Additional customer observation and interview data will     be collected, as well as manager interviews and restaurant environment assessments. Process     evaluation measures will also evaluate the implementation of the intervention.   "
59120|NCT02511704|"     The purposes of this study are 1) to determine the pharmacokinetics of nicotine after     multiple dose administration by electronic cigarette and 2) to compare the acute effects of     multiple dose of nicotine administrated by electronic cigarette compared with those obteined     by cigarette.   "
59121|NCT02511691|"     Based on PET (18-PSS232) and MRI, glutamate release after N-acetylcystein challenge will be     monitored in human brains.   "
59103|NCT02511925|"     If patients acquire a new infection whilst in hospital this can cause significant morbidity,     prolonged hospitalisation and even death. Indeed, there is much public concern about     infections such as MRSA. Patients who require intensive care are probably at the greatest     risk.      Appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal     of many patient safety initiatives. Worldwide, hand hygiene compliance has been estimated at     only 38.7% despite the intervention being simple and cheap. Reasons for poor compliance     include lack of time, skin irritation, lack of facilities, intensity of workload and     forgetfulness. Furthermore, since cross infection may not be apparent for some days, staff     may not associate their (lack of) actions with having caused harm.      Measuring compliance levels enables staff to understand whether they could improve. Direct     observation of staff is labour intensive and is not continuous or universal. We will monitor     hand hygiene compliance with a newly developed electronic system (MedSense, General Sensing     Inc.). We will use the data to provide feedback to the staff in several ways. We hypothesise     that comprehensive personalised feedback will reduce healthcare associated infections. We     will undertake the study in three intensive care units.   "
59104|NCT02511912|"     This is a prospective, non-randomized, open label, single-arm multi-center study.   "
59105|NCT02511899|"     Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit     powder on cutaneous microcirculation and endothelial function.   "
59106|NCT02511886|"     This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in     the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving     AP, one subject will receive placebo.   "
59107|NCT02511873|"     This is a Phase II, 2 arm randomized crossover study. Subjects will be assigned to either     active agent or placebo and then crossover to the other arm. This study is designed to     evaluate whether Fycompa improves the quality of life in patients with small fiber     neuropathy.   "
59110|NCT02511834|"     Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective,     multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi     vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass     grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the     right territory and one or more SVGs to the left territory. Of all vein grafts, one will be     selected randomly to receive treatment with VEST and another designated Control.   "
59111|NCT02511821|"     This pilot clinical trial studies an electronic monitoring device of patient-reported     outcomes (PROs) and function in improving patient-centered care in patients with     gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way     of asking patients about the quality of life, symptoms, and activity using online surveys and     an activity tracking watch may make it easier for patients to tell their doctors and nurses     about any issues before and after surgery. Electronic systems of assessing PROs may increase     the depth and accuracy of available clinical data, save administrative time, prompt early     intervention that improves the patient experience, foster patient-provider communication,     improve patient safety, and enhance the consistency of data collection across multiple sites.   "
59112|NCT02511808|"     The purpose of this study is to understand how certain interventions help people reduce or     quit their drinking and how certain interventions may help best at certain points in time in     the change process.   "
59113|NCT02511795|"     The purpose of this Phase 1b, multi-centre, dose escalation study is to find the maximum     tolerated dose (MTD) of AZD1775 combined with olaparib in patients with refractory solid     tumours   "
59114|NCT02511782|"     The aim of this study is to measure local inflammatory responses in patients undergoing an     allogeneic stem cell transplant and attempt to define any set of biomarkers that are     significantly altered in acute or chronic skin graft versus host disease.   "
59115|NCT02511769|"     The proposed study will determine whether the efficacy of WebMAP cognitive behavioral therapy     (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and explore whether     the intervention is feasible and acceptable to this population. Feasibility of     multi-institutional recruitment from sickle cell centers will also be determined. The     short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a     multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral     intervention in a large population of youth with SCD. The long-term goal of this research is     to develop effective, easily accessible, behavioral pain interventions for youth with SCD to     reduce the long-term impact of pain on function, quality of life, and health service use in     this population.      The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized     controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in     reducing pain and functional impairment in youth with sickle cell disease. (Figure 1)     Subjects will be randomized to either the behavioral intervention or the online patient     education control group. The treatment protocol will be implemented over 8 weeks in     Internet-based treatment modules. The primary study outcome is pain and functional impairment     measured at baseline, immediately post-treatment, and at 3-month follow-up.   "
59116|NCT02511756|"     The primary objective of this study is to investigate the anti-angiogenic effect of     bevacizumab measured by CTP as a predictive marker for efficacy measured by progression-free     survival (PFS) in mCRC patients under first-line bevacizumab-containing,     fluoropyrimidine-based chemotherapy   "
59117|NCT02511743|"     The aim of this study was to evaluate knowledge and behavior of physicians regarding     Hepatitis B Virus. The investigators designed a 30-item self-administered questionnaire     assessing physicians' knowledge and behavior regarding chronic Hepatitis B Virus infection.     These results provide data support for updating guidelines, continuing training, and even     developing policies in medical insurance.   "
59118|NCT02511730|"     The purpose of this pilot is to provide credible performance estimate information in order to     conduct subsequent reader studies.   "
83098|NCT02198313|"     The objective of the present study is to obtain information about the safety and tolerability     of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data   "
59124|NCT02511652|"     The aim of the study is to compare the performance of two supraglottic airway devices (SGA),     the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic     laparoscopy in the trendelemburg position.      Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion,     quality of ventilation, endoscopic view of the glottis, gastric tube passage and     complications.   "
59125|NCT02511639|"     The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus     with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic     breast cancer.   "
59126|NCT02511626|"     Endometriosis, one of the most common diseases of women during their reproductive period.,     may present a chronic disabling disease with major impact on women's life. Therapeutic     options are limited and recurrence of disease symptoms is frequent.      The current study investigates the quality of life and several risk factors for the     development of endometriosis as well as satisfaction with medical support in a minimum of 600     women with different stages of endometriosis and the same number of control women matched for     age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated     pain a second group of 100 women with chronic abdominal/pelvic pain not related to     endometriosis is investigated. Recruitment takes place in different university clinics, and     districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without     any evidence for endometriosis presenting for annual routine gynaecological controls are     collected at the same places.      A composition of different internationally validated questionnaires as well as specific     questions on dealing with endometriosis is used to collect information on the quality of life     and potential risk factors for endometriosis. Questions on sexuality and partnership are also     distributed to women's partners. All diagnosis of endometriosis and classification of ASRM     (American Society for Reproductive Medicine) disease stages are based on woman's medical     charts.   "
59127|NCT02511613|"     The purpose of this study is to evaluate anatomical and functional effect of combination     therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly     ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.   "
59131|NCT02511561|"     This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa.     Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study     is designed to characterize safety, procedural factors and clinical effect of OTO-201     administered in subjects with otitis externa.   "
59132|NCT02511548|"     The main objective of this study is to reach 80% circumcised men in a random sample of men     living in the township of Orange Farm (South Africa).   "
59133|NCT02511535|"     Allergic patients especially those undergoing de-sensitization treatment have an altered     immune responsiveness. The investigators aim to find out whether this influences immune     responses to primary and booster vaccinations.   "
59134|NCT02511522|"     The purpose of this study is to see whether one dose of palliative radiation therapy directed     to the liver in combination with standard BSC might help to reduce liver pain/discomfort due     to cancer when compared to getting standard BSC alone.   "
59135|NCT02511509|"     Electroconvulsive therapy has been used in clinical practice since 1938, a number of     randomized trials found significant differences favoring ECT in response rates between     individuals with depression receiving real and sham ECT. Results of early studies performed     on patients with schizophrenia weren't so clear, only few of these trials found appreciable     differences between real and sham ECT in clinical outcome. The recent, more reliable studies     have found that ECT is efficacious on different symptoms which might be present in the course     of schizophrenia, for example, psychotic and affective ones, as well as suicidality. The     serious complications of electroconvulsive therapy are rare, however, more frequent side     effects may include cognitive impairment and postictal delirium. Thus, the researchers try to     develop new, more effective and less harmful procedures of ECT, like bifrontal electrodes.     The available studies revealed that bifrontal ECT has equal efficacy to bitemporal ECT with     less cognitive impairment, but the literature examining this placement is limited to major     depressive disorder and the results are inconsistent. In the worldwide literature there is     lack of studies regarding the use of bifrontal ECT among patients with schizophrenia. It is     interesting how bifrontal ECT would affect axial symptoms of schizophrenia, since the     electrodes in this procedure are placed over the brain areas responsible for negative     symptoms. This randomized, double blind study is going to assess whether the bifrontal ECT is     more effective in the treatment of positive and negative symptoms of schizophrenia, has less     harmful impact on the cognitive functions and decrease the frequency and severity of     postictal delirium comparing to the bitemporal ECT. Moreover, as the first worldwide will     assess the brain dopaminergic activity with the use of PET in the patients with schizophrenia     after ECT and the impact of the ECT on the concentration of such neurotrophins as     brain-derived neurotrophic factor-BDNF, neuron specific enolase-NSE and protein S100B.   "
59136|NCT02511496|"     This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV)     infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.   "
59137|NCT02511483|"     This study is a randomized, double-blind, placebo controlled clinical trial. The main purpose     of this study is to determine if postsurgical pain ratings are improved with treatment with     oral Propranolol, and if the effectiveness of treatment can be modified by the presence or     absence of SNPs (Single Nucleotide Polymorphism) associated with Cathecol-O-MethylTransferase     (COMT) and mu-opioid receptor (MOR1) activity. The treatment period will last for three days     and the observation period will last for six months. Effectiveness of treatment will be     assessed by means of morphine consumption through quantitative evaluation of IV-PCA (Patient     Controlled Analgesia) morphine as primary outcome measure.   "
59138|NCT02511470|"     The purpose of this study is to determine if the use of a metronome improves chest     compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric manikin.   "
59176|NCT02510976|"     Controlled cross-over study of prucalopride 2 mg daily or placebo in gastroparesis     (idiopathic or diabetic). Patients will be randomized to 4 week treatment with the first     regimen (double-blind), followed by a 2-week washout and 4 week treatment with the second     regimen in cross-over.   "
59139|NCT02511457|"     Measurement of the cardiac output is one of the important hemodynamic monitoring tools in     cardiac surgery. It helps determine the type of medications needed to maintain optimal     hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary     artery catheter is considered has the gold standard for the measurement of cardiac output.     Investigators would like to compare the most popular minimally-invasive devices used to     measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution     method at various phases of the cardiac surgery.   "
59140|NCT02511444|"     The purpose of this study is to evaluate the test characteristics of a rapid intrapartum     real- time polymerase chain reaction (RT-PCR) compared to the intrapartum GBS culture as the     standard in preterm patients presenting with threatened preterm labor or with obstetric     indications for preterm delivery.   "
59141|NCT02511431|"     Background:      - Chronic hepatitis D is a liver disease caused by the hepatitis D virus. It can be severe     and progressive. Most people with hepatitis D will develop scarring and damage to the liver.     There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the     drugs lonafarnib and ritonavir can help people with chronic hepatitis D.      Objective:      - To find out if treatment of hepatitis D with lonafarnib and ritonavir is safe and     effective.      Eligibility:      - People 18 years of age and older with chronic hepatitis D. They must not have HIV or other     major illnesses.      Design:        -  Participants will be screened with medical history, physical exams, and blood tests.        -  Participants will have 24 weeks of treatment. They will then have 24 weeks of follow-up.        -  Participants will be in 1 of 6 treatment groups. Those in each group will receive          different doses of the study drugs. Some groups will start with placebo but will receive          treatment after 3 months of placebo.        -  Participants will also take drugs to treat hepatitis B.        -  Participants will have many visits. These will include:        -  One three-day stay at the Clinical Center        -  Physical exams        -  EKG: small sticky patches will be put on the chest, arms, and legs to trace heart rhythm        -  Ultrasounds of the abdomen        -  Urine and blood tests        -  Stool samples        -  Eye exams        -  Evaluations by a reproductive endocrinologist (women) or urologist (men). Men may          provide a sperm sample (optional).   "
59142|NCT02511418|"     This study was done to determine whether Simvastatin (a medication commonly used to treat     patients with high cholesterol levels in the blood increases blood flow to the kidneys and     improves renal function in normal volunteers and patients with impaired renal function     secondary to polycystic kidney diseases.   "
59143|NCT02511405|"     The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus     bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.   "
60526|NCT02493322|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drug associations in the essential hypertension control.   "
59144|NCT02511392|"     Objectives.-Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive stimulation     methods that became widely used as therapeutic tools in neuropsychiatric research. The aim of     this study is to Evaluate the therapeutic impact of different frequencies of repetitive     transcranial stimulation (1HZ, 10HZ) in OCD patients. Material and Methods; Forty five     patients of OCD were participated in the study. All patients fulfilled the diagnostic     criteria of DSM-IV-TR. The mean age of the patients was 27.1+4.5 years. Each patient was     subjected to the following: Yale-Brown obsessive compulsive scale (Y-BOCS), Hamilton Anxiety     Rating Scale (HAM-A), and Clinical Global Impression - Severity scale (CGI-S). The patients     were randomly classified into three equal groups using closed envelop: 1st group received 1     Hz rTMS at 100% of the RMT, 2nd group received 10 Hz rTMS with intensity of 100% of the RMT     and 3rd group was sham group received the sham stimulation with a total 2000 pulses every day     for each group for 10 sessions. Follow up of the patients using the same previous scales     after the end of sessions and 3 months later.   "
59145|NCT02511379|"     The purpose of this study is to evaluate the efficacy and safety of Systane® Balance     following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye. This study     will be conducted in India.   "
59146|NCT02511366|"     The appearance of intact macronutrients in the small intestine induces an intestinal brake; a     negative feedback mechanism from different parts of the intestine to the stomach, the small     intestine and to the central nervous system. These processes inhibit food processing,     appetite sensations and food intake, and furthermore they increase feelings of satiety and     satiation. Several studies showed that intraileal infusion of nutrients resulted in a     reduction in food intake. However only acute effects were investigated in these studies and     thus far it is not known whether repetitive (intermittent) infusion results in adaptation to     repeated exposure and, thus, a lowered ileal brake response.   "
59147|NCT02511353|"     In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40%     in 2008, where it has now stagnated. Innovative approaches are needed to continue towards     elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the     control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at     this dose has a potent, but short-lived effect for 6-11 days on mosquito survival,     egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal     effects. Previous studies have shown ivermectin is very well tolerated and safe even up to     2,000 mcg/kg. This dose finding study will evaluate the transmission blocking effect of     high-dose ivermectin to define the optimal dose for future use of ivermectin in combination     with artemisinin-based combination therapy (ACT) for mass drug administration (MDA). It     explores a research question of global relevance. A prolonged transmission blocking effect of     ivermectin could have substantial consequences for malaria control in the next decades. The     results are expected to inform national malaria control programs in malaria endemic     countries, to inform WHO guidelines, and to contribute to the regulatory process.   "
59148|NCT02511340|"     Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib     in accelerated or blastic Phase chronic myelogenous leukemia patients.   "
59159|NCT02511197|"     This is an open-label positron emission tomography/computed tomography (PET/CT) study to     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PRGD2 in lung     injury (LI) and pulmonary fibrosis (PF) patients. A single dose of nearly 111 MBq     68Ga-NOTA-PRGD2 (≤ 40 µg NOTA-PRGD2) will be intravenously injected into patients with LI/PF.     Visual and semiquantitative method will be used to assess the PET/CT images.   "
59149|NCT02511327|"     Young infants are most vulnerable to severe disease and even death when infected with     Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee     protection of neonates. During the last weeks of pregnancy, maternal IgG antibodies are     transferred actively to the fetus. Administration of a pertussis containing vaccine during     pregnancy offers protection through high titers of maternal antibodies transferred to the     child. Since transplacental transport is immature, infants who are born prior to 37 weeks of     gestation, might be vulnerable to pertussis infection even though maternal vaccination was     administered, but specific data are lacking. The primary aim of this observational study is     to measure whether vaccination during pregnancy offers protection to preterm born infants     through higher titers of maternal antibodies, despite immature transplacental transport. Four     cohorts of mother-infant pairs will be recruited: term versus preterm born infants, born from     either vaccinated women or not vaccinated women. These mother-infant pairs are recruited     according to the vaccination status of the mother and to the gestational age at delivery.     Pertussis specific antibody titers (anti-Pertussis Toxin, anti-Filamentous haemagglutinin,     anti-Pertactin titers) will be monitored in blood samples of the mothers at delivery to     measure the possible influence of both gestational age and maternal vaccination status. In     order to measure the decline of maternal antibodies in the first weeks of life, blood will be     taken from cords as well as from infants at 8 weeks of age, before the first infant pertussis     vaccine is administered.      Pertussis antibodies to the same antigens will be measured in all infants after a primary     series of acellular pertussis vaccines administered at 8,12 and 16 weeks of age and before     and after a booster dose in the second year of life.      In addition, cellular mediated immune responses will be evaluated in a subgroup of infants     before and after a primary series of infants vaccines. A last goal is to measure whether     vaccination during pregnancy could offer additional maternal antibodies through breast milk.     Again a comparison is made between preterm and term born infants, born from either vaccinated     or unvaccinated women. The amount of lactoferrin and pertussis toxin specific IgA in breast     milk samples will be measured in samples taken at birth (colostrum), and at several time     points afterwards as long as breastfeeding is continued.   "
59150|NCT02511314|"     The purpose of this study is to compare the use of an electronic incontinence identification     system with nursing home support (Tena Identifi) versus usual care on the quality, resource     use and outcomes of continence care for older residents of nursing care homes.   "
59151|NCT02511301|"     The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™),     which is attached to soft biometric patches worn on the body, can improve early breast cancer     detection along with mammography or as a stand alone device.   "
59152|NCT02511288|"     The goal of this project is to create a biological collection of blood samples from patients     with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) with clinical annotations.   "
59180|NCT02510924|"     Airtraq sp has been proven effective for intubating patients presenting with difficult     airway.      The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.      By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the     visualisation of the tracheal inlet is possible for all the airway providers.      The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves     success rate of intubation (primary endpoint), as well as confort of the airway provider,     shortens time for intubation and reduces injury to the patients.   "
59259|NCT02509897|"     To study the effects of hypoxia at rest and during moderate physical activity on     cardiorespiratory fitness, resting, postprandial and exercise activity energy expenditure,     immunoregulatory functions and serum erythropoietin levels in relapsing-remitting multiple     sclerosis patients.   "
60587|NCT02492529|"     Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.   "
59153|NCT02511275|"     Surgery plays a central role in kidney cancer management being the only therapy that offers     the possibility of healing the patients. Currently, the partial nephrectomy is a standard     technique because it meets the principle of nephron sparing surgery. A partial nephrectomy     requires a control of the renal blood flow using a clamp, which can be parenchymal or     vascular (pedicular). In France, most of the centers use pedicular clamping. It is well     established that this technique results in warm ischemia of the entire healthy parenchyma and     can lead to permanent kidney damages. Currently, no study evaluated the impact of parenchymal     clamping on the healthy parenchyma.      The aim of the investigators study is to evaluate the nephrotoxicity of the healthy     parenchyma due to parenchymal clamping during partial nephrectomy. This assessment will be     done through a microdialysis technique. The microdialysis probe is directly implanted in the     healthy unclamped parenchyma and will allow us to measure in real time, during the surgery,     the biological changes related to anaerobic metabolism of renal interstitial space. All those     measures will be completed by urinary and plasmatic assessments. Oxidative stress will be     assessed using four markers of tubular viability : Interleukin 18 (IL18), Kidney Injury     Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C and four     parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose.      This is a prospective pilot study limited to 10 patients included over 12 months. Depending     on the results, it will be further developed by a second study comparing parenchymal with     pedicle clamping.   "
59154|NCT02511262|"     The objective of this Clinical Trial is to define the methods to be used to document that     illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument,     with throat swab samples collected from symptomatic patients.   "
59155|NCT02511249|"     While perinatal ischemic stroke is the most frequent form of childhood stroke, early     determinants of outcome remain poorly understood. Two main structural biases limit the     accuracy of most studies: heterogeneity of the population and short follow-up.      Perinatal ischemic stroke includes several conditions that differ in pathophysiology and     timing of occurrence. Yet, it is not surprising that risk factors and outcome depend     primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal     insult. Even though the original lesion is static and focal in perinatal stroke, its     consequences grow over time within the maturing brain and affect all fields of     neurodevelopment.      The objective of the AVCnn study was to delineate the determinants, clinical and imaging     presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal     arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the     opportunity to regularly monitor a large cohort of children having suffered an NAIS.   "
59156|NCT02511236|"     The importance of reducing tobacco-associated health disparities between cannot be     understated. Racial/ethnic minorities are less likely to quit, and tend to have elevated     stress and depressive symptoms, which may contribute to cessation disparities. Cognitive     behavioral therapy (CBT) for cessation addresses these concerns and has the potential to     reduce/eliminate disparities. Preliminary research found racial/ethnic differences in     baseline perceived stress and depressive symptoms. Following CBT, these differences were no     longer present. Moreover, compared to Whites, African Americans exhibited blunted     hypothalamic-pituitary-adrenal (HPA) axis functioning. This randomized controlled trial (RCT)     will be the first to test the impact of CBT on smoking cessation disparities. The specific     aims are to: (1) Examine the effects of CBT on perceived stress and depressive symptoms in a     racially/ethnically diverse sample; (2) test the efficacy of CBT for eliminating smoking     cessation disparities; and (3) examine physiological distress as an underlying mechanism for     the effects of CBT on racial/ethnic minority smokers (exploratory). It is hypothesized that     CBT will eliminate racial/ethnic differences in distress symptoms compared to the general     health education (GHE) control group. A condition and race/ethnicity interaction on 7-day     point prevalence abstinence (ppa) is also expected, with no racial/ethnic differences in     cessation in the CBT condition only. It is also hypothesized that HPA functioning will     mediate the effect of CBT on smoking cessation, particularly among racial/ethnic minorities.     This study has implications for eliminating disparities in psychosocial factors related to     cessation, and disparities in success. Addressing stress and depressive symptoms through CBT     may facilitate cessation, particularly among racial/ethnic minorities.   "
59157|NCT02511223|"     This is an open label, single arm, phase II trial of Olaparib for PDAC patients with     BRCAness. All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily.     Treatment will continue until progression, intolerable toxicity or as per patient preference.      Primary objective:      To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal     adenocarcinoma (PDAC)with BRCAness (BRCA-Breast Cancer susceptibility gene).   "
59158|NCT02511210|"     The researchers aimed to investigate that preoperative anxiety scores of patients who are     informed about the anesthesia before surgery with using State-Trait Anxiety Inventory and     Amsterdam preoperative anxiety and information scale tests together.   "
59161|NCT02511171|"     The aim of this research is to assess the acceptability of using a mobile folding screen for     blinding parents of infant study participants in clinical trials of osteopathic     interventions. The preliminary data of this acceptability study will inform future randomized     controlled trials with infant participants where parental blinding is required. 30     excessively crying infants will be randomly allocated to 2 groups, one group receives     osteopathic intervention, the other group does not receive treatment. All infants are treated     (or not) behind a mobile folding screen, so that parents are not aware of group allocation.     After a 'treatment' period of 20 min, the screen is removed, and parents are asked to fill in     an acceptability and blinding success questionnaire.   "
59162|NCT02511158|"     In this study we will examine patients who have undergone anterior cruciate and/or posterior     cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury,     contralateral tear and functional outcomes at least two years after surgery.   "
59163|NCT02511145|"     Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy     volunteers to compare the effect on MAL penetration into the skin following various     mechanical penetration enhancement techniques.   "
59255|NCT02509949|"     Delirium, an acute change in mental status, is a serious medical complication among     hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective     disorders and cognitive disruptions.      One vulnerable period for developing delirium is in the postoperative days. Postoperative     delirium often initiates a cascade of adverse consequences including an increase in length of     stay and hospital costs, and greater mortality. The investigators have observed that the     incidence of postoperative delirium in patients after renal transplantation is about 20-30%     in our hospital.      Several studies have revealed that dexmedetomidine, as a widely used sedative during     anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The     investigators aim to examine whether administration of dexmedetomidine can reduce     postoperative delirium after living donor renal transplantation in adult patients.   "
59164|NCT02511132|"     Based on the limited accrual to Part 1 of this study, Gradalis is opening Part 2 of this     clinical protocol to assess the safety of Vigil immunotherapy in combination with irinotecan     and temozolimidetemozolomide. Part 2 will be conducted at the same centers as Part 1,     studying intradermal autologous Vigil cancer vaccine (1.0 x 10e7 cells/injection; minimum of     4 to a maximum of 12 administrations) in patients with metastatic Ewing's sarcoma Family of     Tumors (ESFT) refractory or intolerant to at least 1 prior line of chemotherapy. Patients     undergoing a standard surgical procedure (e.g., tumor biopsy or palliative resection) may     have tumor tissue harvested for manufacture of investigational product. Patients meeting     eligibility criteria including manufacture of a minimum of 4 immunotherapy doses of Vigil     will be registered to receive: (i) oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5,     total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose     250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle),     intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be     administered at home), and (iv) Vigil 1.0 x 10e7 cells/injection, intradermally on Day 15 and     every 3 weeks thereafter. One cycle = 21 days.   "
59165|NCT02511119|"     The aim of this study is to develop a predictive model of risk of developing melanoma. The     investigators will used artificial intelligence techniques to analysed images patterns     obtained by clinical and dermoscopic pictures. The investigators want to defined a new     predictive risk model obtained from genetic information and image analysis of pigmented     lesions. This model could help to discriminate more accurately those patients who are most     likely to develop melanoma in a high-risk population.   "
59166|NCT02511106|"     To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal     Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma,     following complete tumour resection with or without adjuvant chemotherapy.   "
59167|NCT02511093|"     The purpose of this study is to determine whether a team-based care (TBC) intervention,     combining physician, nurse and pharmacist care improves BP control compared to usual care at     6 months among outpatients with uncontrolled hypertension.   "
59168|NCT02511080|"     Using the spot-on device for monitoring core body temperature during colon laparoscopic     surgery and prevent non-therapeutic hypothermia.   "
59169|NCT02511067|"     The purpose of this study is to investigate the safety, tolerability and efficacy of     Ranibizumab and Tocilizumab alone and in combination in eyes with Diabetic Macular Edema.   "
59170|NCT02511054|"     Background:      - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito     that carries the parasite bites them. Although malaria does not occur in the United States,     many people in Africa, Asia, and South America do get malaria. In some cases, malaria can     cause death. In 2013 alone, 584,000 people died due to malaria. Researchers want to find ways     to prevent and treat malaria.      Objective:      - To find out if combining live, infectious malaria parasites (known as Sanaria PfSPZ     Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] and     chloroquine [CQ]) is safe and can provide people protection against malaria. The Sanaria     PfSPZ Challenge has been used in other studies without significant side effects.      Eligibility:        -  Healthy people ages 18-50 who weigh less than 170 pounds and are not pregnant or          breastfeeding        -  No history of hepatitis B, hepatitis C, or HIV infection        -  Not currently enrolled in a clinical trial that involves a research drug or vaccine        -  Have not traveled to an area with high malaria transmission within the last 5 years        -  Never diagnosed with malaria in the past      Design:        -  Participants will be in 1 of 4 groups.        -  Participants will receive a combination of injections and drugs. What combination they          will receive will depend on what group they are in. This combination of injections and          drugs may include:             -  Injections of Sanaria PfSPZ Challenge (live, infectious malaria parasites) into a               vein             -  FDA approved antimalarial drug called chloroquine (CQ)             -  FDA approved antimalarial drug called pyrimethamine (PYR)             -  FDA approved antimalarial drug called Malarone             -  The study will last approximately 3-7 months (depending on which group participants               are in).        -  There will be up to 68 study visits for three groups. One group will have up to 27 study          visits. During the study visits, participants may have:             -  Medical history review             -  Physical exams             -  Electrocardiogram (ECG): soft electrodes will be placed on the skin. A machine will               record the heart s electrical signals to evaluate heart function.             -  Blood and urine tests             -  Medication given in the clinic under direct observation             -  Injection of Sanaria PfSPZ Challenge into a vein             -  Participants will receive a diary, thermometer, and ruler to record their body               temperature and any symptoms.   "
59177|NCT02510963|"     To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV)     during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a     randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with     high HBV load and normal liver function will be treated with tenofovir during the middle or     late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th     gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th     gestational week of mothers, the intrauterine HBV infection rate of infants will be compared     across the three groups.   "
59227|NCT02510313|"     The proposed study will test the effectiveness of the Strong Families, Thriving Children     Sugira Muryango program as delivered by community based workers and aligned with the     Rwandan social protection system. Sugira Muryango is a preventive, family-based model that     uses home visiting and coaching to encourage responsive parent-child interactions and     discourage violence and harsh punishment targeting families living in extreme poverty.     Integration of scalable, cost-effective interventions into poverty-reduction and other social     welfare programs has great potential as an effective means to promote child development and     reduce familial violence and in a range of culturally diverse, low-resource settings.   "
59181|NCT02510911|"     Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a     result, hospitalization may be prolonged leading to increased cost. A recent randomized     controlled trial from the University of Heidelberg showed that consumption of regular black     coffee after colectomy is safe and associated with a significantly faster resumption of     intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is     unknown but caffeine seems to be the most likely stimulating agent.      Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis     after elective laparoscopic colectomy?      Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine,     or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.      The study is a randomized, controlled trial, with blinding of physicians, patients and     nursing stuff (evaluating the endpoints).      Primary endpoint will be the time to first bowel movement.   "
59256|NCT02509936|"     This study seeks to evaluate the impact of an intensive home-based education intervention     targeting severely stunted Guatemalan children for catch up growth and improved development.     Half of the children in the study will receive standard of care, which includes micronutrient     supplementation and a food ration. The other half of children in the study will receive, in     addition to the above, home-based dietary assessment and individualized parental nutrition     education.   "
59171|NCT02511041|"     Background:      - A congenital disorder of glycosylation (CDG) affects the cells that make up the organs and     tissues. In these cells, sugar molecules do not properly attach to other molecules, which are     the basic building blocks of cells. Changes in sugars seen in people with CDGs may lead to     allergies and can change people s ability to fight infections. Researchers want to see if a     sugar supplement called N-acetylglucosamine can help people with CDGs who have detectable     changes in their immune systems.      Objective:      - To see if N-acetylglucosamine can help cells to function in a healthy way in people with     CDGs.      Eligibility:      - People at least 2 years of age who have a CDG and immune system changes.      Design:        -  Participants will be screened with a physical exam, medical history, and blood tests.        -  One month later, participants will repeat the blood tests from the screening visit.          Blood will be drawn on 2 different days in the same week.        -  Participants will get N-acetylglucosamine supplements and instructions for how to take          them. N-acetylglucosamine is a powder that can be added to food or drink.        -  Participants will have a physical exam and blood tests every month during the study.        -  After taking N-acetylglucosamine for about 4 months, participants will have more blood          tests. They will get more N-acetylglucosamine supplements and a nucleoside supplement.          The second supplement may be a powder or tablets that may be crushed and added to food.          Participants will take both supplements for 5 months.        -  After about 10 months in the study, participants will have 2 more visits in the same          week for the same blood tests.   "
59172|NCT02511028|"     Background:      - Contrast agents help things show up better on magnetic resonance imaging (MRI) scans.     Researchers want to see if the drug ferumoxytol is a good contrast agent. They want to     determine that it does not cause prolonged MRI changes in the brain and to see if it helps     identify inflammation in multiple sclerosis      Objective:      - To learn how ferumoxytol can be used to image inflammation in multiple sclerosis (MS).      Eligibility:        -  Adults ages 18 70 who have MS.        -  Healthy volunteers ages 18 70.      Design:        -  Participants will have 5 clinic visits over 6 months.        -  Participants will be screened with a medical history, neurological exam, and blood draw.          Full clinical measures will be obtained.        -  Participants will have a 7 tesla brain MRI scan that may include gadolinium contrast          agent. The MRI is a metal cylinder in a strong magnetic field. The participant will lie          on a table that can slide in and out of the cylinder.        -  During visit 2, ferumoxytol with be given through a catheter (a thin plastic tube) that          is inserted with a needle into a vessel in the arm.      <TAB>- Participants will then have a 7 tesla MRI scan of the brain..        -  At each of the next 3 clinic visits, participants will have a 7 tesla brain MRI and have          blood drawn. The MRIs may include gadolinium.        -  Participants may have a full neurologic exam at these visits. At the final visit, full          clinical measures will be obtained.        -  Participants may have more MRI scans if a 6-month MRI shows ferumoxytol still in the          brain.   "
59174|NCT02511002|"     Background:      - Influenza is a common viral infection. But it can be deadly for some people. Researchers     want to learn more about how the body fights this virus. They want to study this in people     who have recently been infected with influenza. They hope this can help them create more     effective influenza vaccines.      Objective:      - To learn about long-term changes in the body s immune system after influenza infection.      Eligibility:      - People who have completed a previous LID Clinical Studies Unit influenza challenge study     and are willing to have samples stored for future research.      Design:        -  Eligible participants will be asked to visit the clinic every 3 months for 2 years.        -  During each visit, participants will have blood drawn from an arm vein using a needle          and a syringe.        -  Participants will have a medical history and physical exam and vital signs performed.          This will include blood pressure, heart rate, breathing rate, temperature, weight, and          finger-measured blood oxygen. They will answer questions about any medicines taken and          possible recent illnesses.        -  If participants have symptoms of influenza, they may have a sample taken from the nose.          A small <TAB>amount of salt water will be sprayed into the nostril with a squeezable          container. The salt water will then run out of the nose and into the container. Or the          inside of the nose will be wiped with a swab that is      similar to a Q-tip.      - Participants will complete a health questionnaire once a month on a secure website.     Participants may also give their responses over the telephone.   "
59175|NCT02510989|"     Syndromic obesity are rare forms of obesity (1% of cases), involving severe obesity and early     to multi organ involvement (mental retardation, dysmorphic, sensorineural damage and / or     endocrine). To date, the genetic defects are identified in only 5% of cases (Prader-Willi     syndrome, Bardet-Biedl syndrome, mutation of leptin or its receptor, the proconvertase-1,     proopiomelanocortin or SIM-1 and TRKB genes, high resolution karyotype or abnormal DNA chips,     ...). Precocity and severity of obesity are those for a little dependent genetic environment.      The investigators aim is to identify new gene variants in subjects with syndromic obesity     sharing common phenotypic features.   "
59178|NCT02510950|"     The early clinical development paradigm for chemotherapeutic agents has significantly     influenced the development of therapeutic cancer vaccines. However, there are major     differences between these two classes of therapeutics that have important implications for     early clinical development. Specifically, the phase 1 concept of dose escalation to find a     maximum-tolerated dose does not apply to most therapeutic cancer vaccines. Most therapeutic     cancer vaccines are associated with minimal toxicity at a range that is feasible to     manufacture or administer, and there is little reason to believe that the maximum-tolerated     dose is the most effective dose.      In a recent article from the biostatistics literature, Simon et al. write that the initial     clinical trial of many new vaccines will not be a toxicity or dose-ranging trial but rather     will involve administration of a fixed dose of vaccine … in most cases the dose selected will     be based on preclinical findings or practical considerations. Using several dose levels in     the initial study to find the minimal active dose or to characterize the dose-activity     relationship is generally not realistic.      Consistent with these recommendations, the general philosophy of the phase 1 clinical trial     is to facilitate a prompt preliminary evaluation of the safety and immunogenicity of the     personalized synthetic long peptide vaccine strategy. The proposed clinical trial will test a     fixed dose of vaccine. There is considerable experience with the synthetic long peptide     vaccine platform. The synthetic long peptide vaccine platform has an excellent safety     profile, and the optimal dose appears to be based on practical considerations (solubility of     the peptide). The dose to be tested in the proposed clinical trial is consistent with other     similar cancer vaccine trials that have been recently completed or are currently ongoing. The     sample size (n=10) will provide a reasonably reliable estimate of the safety and     immunogenicity of the vaccine.   "
59179|NCT02510937|"     Participation in the study will last for 3months, with a 1 month screening phase.   "
59257|NCT02509923|"     The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10     mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male     Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.   "
59182|NCT02510898|"     The purpose of this study is to determine whether a 6-week writing to heal     seminar/workshop/class, Transform Your Life: Write to Heal, raises resilience scores as     measured by the Connor-Davidson Resilience Scale for people who have recently experienced an     emotional or physical trauma.      Eligible subjects will be adults who self-identify as having had a recent emotional upheaval     or physical health challenge. Potential subjects will be recruited through the use of flyers,     advertisements, and emails to the Duke Integrative Medicine email list. Subjects will     complete pen and paper measures at baseline and immediately post-treatment, including: the     Connor-Davidson Resilience Scale, the 10-item Perceived Stress Scale, The 20-item Center for     Epidemiological Studies Depression Scale, the 22-item Rumination Response Scale, and a     baseline questionnaire.      The investigators aim to target a sample of 30 completers by enrolling 37 participants. The     risks of participation in this study are minimal, and include temporary sadness after the     initial writing experience.   "
59183|NCT02510885|"     The objective of this study is to image retinal vascular alterations in patients with retinal     disease using the AngioVue OCT-A system and understand the information these images provide.     The investigators will image study participants who have retinal diseases with the AngioVue     unit (Optovue) and will collect relevant clinical data to understand the nature of the     information contained in images obtained on AngioVue. This study being conducted under an     abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks     related to light exposure will be managed by ensuring that the exposure to the AngioVue light     source is well below maximum permissible limits for safe exposure.   "
59184|NCT02510872|"     Early detection of viable residual tumor or early neoplastic recurrence represents a real     challenge in monitoring patients treated with concomitant chemoradiotherapy squamous cell     carcinoma of the upper aerodigestive tract.      The locoregional recurrence rate is indeed high (up 40%) over the first two years of this     therapeutic method.      The conventional imaging methods such as CT and MRI appear limited in terms of sensitivity     because of the many post-treatment changes are fibrosis, tissue edema and the tissue     distortion.      PET-CT 18F-FDG proves to be a non-invasive, reliable for the detection of residual tumor and     metastasis, even in the absence of clinical signs.      To date, the acquired CT examination in the same time and in the same position that PET is     performed without iodinated contrast injection, used for anatomical identification and     attenuation correction of PET fused images. The patient usually has a second CT imaging,     centered on the neck with contrast injection iodized within the radiology department.      To date, no team has yet studied the interest of the PET-CT 18F-FDG coupled with a CT scan     with contrast injection iodized in the diagnosis of early recurrence in head and neck     malignancies while interest of the contrast agent injection has been demonstrated in ovarian     neoplastic recurrence research, pancreatic and colon.   "
59228|NCT02510300|"     This Registry will enroll adolescent and pediatric participants who received at least one     Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a     Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry     is to determine the long-term safety of anti-HCV regimens in the pediatric population.     Secondary objectives of this Registry are to determine whether subsequent detection of HCV     RNA in participants who relapse following sustained virologic response (SVR) represents the     re-emergence of pre-existing virus, the development of resistance mutations, or whether it is     due to re-infection, and to characterize resistance mutations and the persistence of     resistance mutations in pediatric participants who did not achieve SVR. Once enrolled,     participants will be followed for up to 5 years.   "
64315|NCT02443831|"     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric     Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed     CD19+ haematological malignancies.   "
59185|NCT02510859|"     Malnutrition is currently a major factor of morbidity and mortality, which poses a major     public health problem in developing countries but also, albeit to a lesser degree and for     different reasons, for industrialized countries. It is recognized that in countries of the     North, from 30 to 60% of hospitalized patients suffer from dénutrition.      In any case, it is covered by an imbalance between the contributions and needs; the two main     mechanisms are a delivery failure (fasting, ingesting difficulty ...) and / or increased     requirements (hypermetabolism ...). In cancer patients the Aero-Digestive Upper Airways     (VADS), this imbalance is even more pronounced than the two mechanisms exist and potentiate.     Patients included in this study are a population at risk, because of their therapeutic     containing at least radiotherapy. It is recognized that this form of therapy exposes dental     complications, mucous, saliva. These complications have a deleterious effect on the     nutritional status of patients.      The diagnosis, treatment and prevention of dénutritions have an important place in the     therapeutic strategies of this type of cancer because it is events whose incidence and morbid     consequences are high and for which there are appropriate nutritional treatments in most cas.     While the complete correction of malnutrition generally passes by the effective etiological     treatment of the causal pathology, therapeutic efficacy of the latter is often conditioned by     the nutritionnel state.      In addition to these concepts, investigators wants to study the benefits of a diet followed     during the irradiation phase of patients with head and neck cancers and New treaties. We     propose a randomized, phase III, open, multicenter, to evaluate the impact of a dietary     consultation at home on the life quality of patients with head and neck cancer including     first therapeutic sequence involves radiotherapy more or less aware. The duration of the     study is 24 months.      The main objective is to evaluate the impact of a dietary consultation at home on the life     quality of patients with head and neck cancer including first therapeutic sequence involves a     more or less sensitized radiotherapy.   "
59186|NCT02510846|"     Profound multiple disabilities also called in French polyhandicap are defined by the     combination of a deep mental disability and severe motor deficit with extreme restriction of     autonomy. Life in institution for people with profound multiple disabilities induces     emotional and educative deficiency and often conducts to behavioral disorders. These     behavioral disorders also impact on quality of life and feelings of caregivers. An intensive     multimodal educative program proposed to patients with profound multiple disabilities can     improve their psychic well-being, reduce chronic pain and improve also quality of life and     feelings of caregivers. The intensive multimodal educative program will be compared to the     usual practice of educative program.   "
59196|NCT02510716|"     The purpose of this study is to evaluate the feasibility, acceptability and preliminary     efficacy of a Scheduled Gradual Reduction (SGR) intervention via SMS (short message service)     text messaging plus SMS Support Messages in decreasing smoking in an older adult rural     population. The SGR group (n=20) will receive a four-week SGR program delivered via SMS text     messages plus SMS support messages. The control group (n=20) will receive SMS support     messages to aid in quitting.   "
59258|NCT02509910|"     This study examines the effect of an algorithm for GDT for patients undergoing major surgery     under routine conditions.   "
59187|NCT02510833|"     Parkinson's disease (PD), neurodegenerative and common from 50 to 60 years, is characterized     by rigidity, bradykinesia and resting tremor that can interfere in the quality of life. To     maintain or improve this, there is the physiotherapy. Problems in access, such as walking and     financial difficulties, make home exercises target of interest. The study aims to assess the     impact of a program of home therapeutic exercises, with individualized approach and remote     monitoring by physical therapist, about signs and symptoms of Parkinson's disease and quality     of life. This is a randomized controlled clinical trial, conducted at the Program     Pró-Parkinson of the Clinics Hospital, Federal University of Pernambuco, Neurology Clinic.     Will be included people of both sexes (50 years) with idiopathic PD, stages 1-3 in Hoehn &     Yahr original; non-institutionalized and independent walking. It will be applied before and     after 12 weeks of intervention (period ON of medication): Survey about Knowledge, Attitudes     and Practice; Questionnaire of Accession; Unified Scale Evaluation of Parkinson's disease     (UPDRS) - subscales II and III; and Parkinson's Disease Questionnaire 39 (PDQ-39).     Participants will be randomized into two groups: Group continued intervention (GIC) and     control group (CG). The GIC will have an meeting with individualized approach (physical     therapist, patient and companion) for guidance on home physical therapy exercises, using the     Manual Pró-Parkinson, then the participant will receive the manual with stretching exercises,     mobility, balance and strength, which will lead to your home as a way to guide their     activities; and receive weekly follow-up by phone calls (to remember the exercises, answer     questions and encourage the continued practice). GC may be attend presentations on home     exercises of the Pro-Parkinson's manual in the days of your query and have the same manual     without remote follow-up by phone calls, usual service procedure. Exercises are oriented to     be performed three times a week for 12 weeks and under the effect of anti-Parkinson     medication. This study will contribute new evidence on the effects of a rehabilitation     program available and inexpensive based on home exercises.   "
59188|NCT02510820|"     This will be a controlled and randomized, single-masked, crossover study in which 48 subjects     will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products     ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up     visits for each solution will take place at one week, two weeks and four weeks: with a     one-week 'wash-out' period between the solutions. Key outcome measures for this study include     biomicroscopic and subjective responses to the lens/solution combinations.   "
59189|NCT02510807|"     The literature has shown that supervised exercise programs for patients with PAD and who     report intermittent claudication (IC) have improved health outcomes, but this is not locally     available. Introducing the use of a pedometer may act as a method to encourage patients to     continue on their independent exercise regimen. There is very little literature which has     examined the effectiveness using pedometers as a measure of compliance within this     population.   "
59190|NCT02510794|"     This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of     three different formulations of ranibizumab delivered via RPDS implant compared with the     standard of care (SOC) intravitreal (ITV) injections of ranibizumab, in participants with     subfoveal neovascular AMD.   "
59191|NCT02510781|"     Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with     human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher     pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when     used the anthracycline instead of carboplatin. The investigators expect to carry out a large     sample size clinical research to optimize the existing therapeutic regimen   "
59192|NCT02510768|"     The study is designed to evaluate the efficacy of two formulations of a cross-linked     tropoelastin matrix given the product codes ELAPR002f and ELAPR002g (collectively referred to     as ELAPR or ELAPR002) for the treatment of Striae Distensae (SD) alba when administered as     intradermal implants.   "
59203|NCT02510625|"     The objective of this study is to investigate arthroscopic treatments of recurrent anterior     shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction     with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The     investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft     will provide better functional outcomes and decreased risk of recurrent     dislocation/subluxation.      This will be a single center, double blinded, randomized controlled trial performed in     Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario     Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation,     and range of motion. A minimum of 200 patients will be enrolled in the study as determined by     sample size calculation. Routine radiographs as well as a pre-operative CT with 3D     reconstruction and MRI are obtained for all patients. The patients will then undergo a     clinical examination and complete a variety of functional and quality of life surveys.     Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid     reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both     groups will follow a standardized rehabilitation protocol. The patient will follow-up with     the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24     month visits the patient will again undergo the structured clinical examination conducted by     a physiotherapist who is blinded to the patients' treatment group. The patient will also     complete the questionnaires at each of these follow-up appointments. Complications, and     subluxation/dislocation events will be documented at each follow-up evaluation. On the basis     of a clinical examination and patient history, the surgeon will diagnose recurrent     instability and categorize it as a traumatic or atraumatic subluxation or dislocation.   "
59204|NCT02510612|"     Dexmedetomidine's Sedative Effect on Diabetic Patient   "
59193|NCT02510755|"     A broad group of disorders is associated with severe stress existence in children or     adolescents. The most characteristic result, and one of the most serious being the state of     post-traumatic stress disorder (PTSD), whose main source consists of physical or sexual     violence, and to a lesser extent, accidents public road or natural disaster, whose child was     the subject or witness. PTSD is associated with a deleterious effect on cognition and     including the mnemonic operation. The painful reminder of the traumatic event is one of the     most disabling symptoms. However, there are many other memory disorders that experimental     studies gradually update. They maintain a close link with emotional regulation that disturbed     you know if PTSD. However the majority of studies on emotion and cognition and their     relationship with brain activity took adult subject. Work in adolescents are few on the     morphological study, on rare neurobehavioral and reduced to two studies of functional     neuroimaging. Contrary to what is observed in adults, morphological studies report     consistently, no reduction in hippocampal volume. There is no study in the idle state. Two     studies in functional MRI, the first highlighted in PTSD patients inhibition of the activity     of the anterior cingulate cortex (ACC) to stimuli such as to evoke the trauma, a second     reported increased activity in the prefrontal cortex Median (mPFC) in a inhibition. The     objective task of our study is to evaluate the impact of psychological trauma on brain     structures involved in the emotional component of the memory (amygdala, hippocampus,     prefrontal cortex in particular). For this, the investigators will take in 33 adolescents,     including patients with posttraumatic symptomatology and matched controls free of trauma age,     several neuroimaging exams, anatomical and functional. The functional review will include     some rest and another in activation during episodic memory task designed to assess the     influence of self-perception on memory impairment observed in patients. The investigators     will check, for each group of patients and controls, the involvement of cortical structures     in relation to the regulation of emotional memory (CCA, amygdala and hippocampus). The     anatomy of the hippocampus benefit specific imaging methods developed in the unit INSERM     U923. Endocrine correlates of stress tests will be studied by a fully-traumatic by salivary     cortisol sampling.      This research will clarify the mechanisms involved in emotional and memory impairments     secondary to psychological trauma, their relationship with self (judgment and self-esteem)     and studying their morphological substrates. A longer-term goal is to offer help in the     diagnosis and monitoring of young patients with posttraumatic symptomatology.   "
59194|NCT02510742|"     Hypothesis:      Stimulation of the SPG at low frequencies (20 Hz)is believed to cause a physiological     parasympathetic upregulation which increases VMCA, concentration and cephalic vessel     diameter.   "
59195|NCT02510729|"     We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow,     activate sensory afferents and provoke a cluster-like attack.   "
59197|NCT02510703|"     Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function,     especially in the coronary arteries, which are a factor of poor prognosis. Following acute     coronary syndrome, the endothelial function abnormalities usually persist for several weeks     before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor     prognostic factor. Investigators assume that global abnormalities of endothelial function in     patients with diabetes may be additive with segmental abnormalities in revascularized     myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there     is no published data showing any relationship between calcium score and endothelial function     abnormalities in these patients. The investigators seek a relationship between calcium score     and persistence of abnormalities of coronary endothelial function in these patients.      The main objective of this study was to compare coronary endothelial function by quantitative     method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary     syndrome.   "
59198|NCT02510690|"     This study aims to analyse the results of national data collected by the e-Dengue Information     System in order to determine the factors associated with disease outcomes in all patients     registered from January 2013 to December 2014.   "
59199|NCT02510677|"     The prognosis of patients with heart failure has improved due to recent breakthrough in     medical treatment and cardiac resynchronization devices. However, there is no paraclinical     parameter to assess response to cardiac resynchronization therapy (CRT). This is a major     issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows     to perform myocardial perfusion imaging in less than 4 minutes and is able to study     myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.      Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular     dyssynchrony in viable segments in patients with heart failure eligible for CRT.   "
59200|NCT02510664|"     The purpose of this study is to determine whether a newly developed intervention is feasible     and acceptable to adolescents with type 1 diabetes and their families and diabetes care     providers, and to evaluate trends in whether the intervention impacts important diabetes     outcomes. The intervention involves diabetes care providers discussing and reinforcing     individuals' and families' diabetes management strengths during routine, outpatient diabetes     care appointments.   "
59201|NCT02510651|"     ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant     repigmentation did not show significant difference with better healing of the donor site.     Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better     results using combination of donor NCECS and recipient cryoblebs.   "
59202|NCT02510638|"     Dengue infection has been identified as the fastest spreading mosquito-borne viral disease by     World Health Organization (WHO), which affects more than 2.5 billion people living in the     subtropical and tropical regions. Malaysia is hyper-endemic with all four dengue virus     serotypes circulating and responsible for the escalating number of cases over the years. As     of 28 February 2015, there are 62 deaths secondary to dengue infection being reported in     Malaysia; and the total number of dengue cases reported in the same period was 23,966 which     is 46% higher than the same reporting period of 2014. Although dengue virus has been     identified for so many years and plenty of research work has been carried out, it was proven     that there are still many aspects that we are not too sure about the disease. Therefore, this     multi-center, observational cohort study is designed to investigate the clinical course of     hospitalized dengue infection in Malaysia. The study population of this study consists of     male or female patients with dengue to be randomly sampled from hospitals in Malaysia. This     study will be conducted in 2 stages whereby the 1st stage will only focus on the basic social     and clinical data to describe the clinical course of dengue as general and the 2nd stage will     collect the more detailed clinical and management data to describe the detailed clinical     course, management and prognosis of dengue. All hospital participation in this study is     voluntary, and approval will be obtained from National Institute of Health (NIH) and Medical     Research Ethics Committee (MREC) prior to any recruitment.   "
59209|NCT02510547|"     CrossBoss First is a single-blind randomized controlled trial that will randomize 246     patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary     Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation     strategy The CrossBoss First study has two primary objectives. The primary efficacy     objective is to compare the procedure time required to cross the CTO or abort the procedure     with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize     that upfront use of the CrossBoss catheter will be associated with shorter procedure time     required for CTO crossing compared with an antegrade wire escalation strategy.      The primary safety objective is to compare the frequency of procedural major adverse     cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation     strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be     associated with similar incidence of MACE compared with an antegrade wire escalation     strategy.      The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure     time (defined as the interval between administration of local anesthesia for obtaining     vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and     total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume;     and (6) number of wires, microcatheters, balloons, and stents used.   "
59210|NCT02510534|"     To determine the difference in clinical pregnancy rates with and without luteal progesterone     support in a young reproductive aged population having undergone ovulation induction with     combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.   "
59233|NCT02510235|"     Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms     of discomfort, visual disturbance, and tear film instability with potential damage to the     ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation     of the ocular surface.      Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted     product of cells that line the joint tissues, which is present at the surface of articular     cartilage and it has been investigated on its roles at the ocular surface, in normal and     pathologic conditions such as dry eye.      The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye     drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution     in subjects with moderate dry eye.   "
59211|NCT02510521|"     Type 2 diabetes is a major public health problem because of its increasing prevalence and     morbidity and mortality that accompanies it. Therapeutic management of this pathology,     lifestyle measures, dietary and physical activity are fundamental. Their observance is     unfortunately too often insufficient, leading to a therapeutic climbing with first oral     antidiabetic (OAD) then the use of insulin therapy.      Yet there is now ample evidence that physical activity improves glucose control in these     patients in particular improving insulin sensitivity after a training period but also after a     single session of physical activity.      Neuro-myo-electrical stimulation (NMES) is used in common clinical practice in physical     therapy, patients with neurological or after orthopedic surgery in particular. In fact, this     method enables improvement of volume and strength, even for denervated muscles. Recent     studies have also shown the benefits of NMES in situations of cardiac or respiratory     readjustments. In addition, NMES is used by top athletes supplements classical training in     order to develop muscle strength or speed recovery.      Investigators propose to test the impact of bilateral quadriceps NMES on insulin sensitivity     in type 2 diabetic patients treated with OAD (excluding glitazone). To do this, investigators     plan to assess their insulin sensitivity by the reference method of hyperinsulinemic     euglycemic clamp before surgery, after a single session of bilateral quadriceps NMES and     after a sequence of daily training 6 days a quadriceps NMES bilateral.      Investigators hope to show an improvement in insulin sensitivity by this method, which would     constitute an alternative to physical activity in the treatment of diabetes type 2. This     procedure would be particularly interesting in diabetic subjects with type 2 counter-     indications or an inability to perform a conventional physical activity.   "
59212|NCT02510508|"     The aim of this study is to determine whether a group format Community Reinforcement and     Family Training (CRAFT) and Self-Directed CRAFT Delivery are more effective than     non-intervention in terms of Concerned Significant Others (CSO) well- being and cost-     effectiveness.   "
59213|NCT02510495|"     The purpose of this study is to determine how different endoscopic papillary balloon     dilatation (EPBD) duration time affects the complications after endoscopic retrograde     cholangiopancreatography (ERCP) in the treatment of common bile duct stones.   "
59214|NCT02510482|"     Calcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the cornerstone     in diagnostics and follow-up is echocardiography. Cardiac biomarkers (such as cardiac     troponins T and I and NT-pro-BNP) hold promise to fulfil a role in early recognition of     complications concerning the aortic valve and decompensation. For this purpose, it is     important to assess the normal biological variation (BV) of cardiac biomarkers in CAVS. The     assessment of biological variation will contribute to a better understanding of fluctuation     of cardiac biomarkers in subjects with stable CAVS. These data will improve monitoring of     CAVS using cardiac biomarkers.   "
59215|NCT02510469|"     The purpose of this study is to assess the efficacy and safety of apatinib as maintenance     therapy after adjuvant chemotherapy in progressive gastric cancer patients with positive     exfoliative cancer cells.   "
59216|NCT02510456|"     This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to     evaluate the efficacy of an investigational imaging technology known as Diffuse Optical     Spectroscopy Imaging (DOSI) in predicting patient response to chemotherapy treatment. DOSI is     a noninvasive imaging method that uses harmless near-infrared light using a simple handheld     probe held against the skin to predict tumor metabolic activity. It uses nonionizing     radiation, requires no external contrast agent and uses low light exposure to human tissue.     DOSI scans can be performed frequently at the bedside in settings such as a doctor's office     or infusion center.   "
59217|NCT02510443|"     Using a very broad survey, the objective is to confirm the effectiveness of the Essure     method, and to obtain more information on the conditions of use as well as on the methods     used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on     patients.   "
59218|NCT02510430|"     Excessive sitting time (sedentary time) has been associated with risk of insulin resistance     and other factors which may be relevant to breast cancer prognosis. This 8-week study tests     different strategies for helping breast cancer survivors to modify their levels of sitting     time. Participants will be assigned with equal likelihood to one of three groups (1) overall     reduction in sitting time, (2) interruption of sitting time with standing breaks, and (3)     usual care.   "
59229|NCT02510287|"     The analgesic approach in labor can be done in different ways, among which the neuraxial     approach has shown the best analgesic results and fetal outcomes. Currently, programmed     epidural intermittent bolus has been included in the neuraxial approach for a better     distribution of the solution into the epidural space as compared with the continuous infusion     strategy. In this study, the investigators seek to compare both strategies in 132 laboring     women.   "
59230|NCT02510274|"     The objective of this study is to assess PK, safety and tolerability of a single oral dose of     ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d.     before or just after each meal   "
59231|NCT02510261|"     The purpose of this study is to evaluate the safety and efficacy of long-term dosing with     ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).   "
64346|NCT02443415|"     The purpose of this study is to assess brain and memory changes in patients with uncontrolled     diabetes (a condition called diabetic ketoacidosis (DKA))   "
59219|NCT02510417|"     The primary purpose of the study is to evaluate whether most closely HLA-matched     multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell     lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus.      Reconstitution of anti-viral immunity by donor-derived VSTs has shown promise in preventing     and treating infections associated with CMV, EBV and adenovirus post-transplant. However, the     time taken to prepare patient-specific products and lack of virus-specific memory T cells in     cord blood and seronegative donors, limits their value.      An alternative is to use banked partially HLA-matched allogeneic VSTs. A prior phase II study     at our institution using trivirus-specific VSTs generated using monocytes and EBV-transformed     B cells gene-modified with a clinical grade adenoviral vector expressing CMV-pp65 to activate     and expand specific T cells showed the feasibility, safety and activity of this approach for     the treatment of refractory CMV, EBV and Adenovirus infections. However, the production     process was lengthy, requiring 8-12 weeks, with exposure to biohazards (B95.8 EBV viral     strain and adenovector), while antigenic competition between different viral components     precluded increasing the spectrum of specificity beyond these three viruses.      Investigator have overcome these limitations and in the current trial, they will evaluate     whether rapidly generated, allogeneic most closely HLA-matched multivirus-specific VSTs,     activated using overlapping peptide libraries spanning immunogenic antigens from CMV,     adenovirus and EBV will be safe and produce anti-viral effects in allogeneic HSCT recipients     infected with one of more of the targeted viruses that are persistent despite conventional     anti-viral therapy. The study agent will be assessed for safety (stopping rules defined) and     antiviral activity.   "
59234|NCT02510222|"     This study is considered a pilot exploratory study. Intervention, prospective, double-armed,     randomized, placebo-control clinical trial.      The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be     studied.   "
59235|NCT02510209|"     This study tested the extent to which TOP®, when replicated with fidelity, produced impacts     on sexual risk-taking behaviors in the short term and the longer term.   "
59220|NCT02510404|"     PIDD represent an expanding group of genetic disorders that compromise immunity against     bacteria, viruses, and fungi. The most severe forms of PIDD cause profound susceptibility to     opportunistic infections due to impaired or absent T-cell immunity. These diseases can be     rapidly fatal unless treated via hematopoietic stem cell transplantation (HSCT). Chronic     viral illnesses are a common presenting feature of many of these disorders, and studies have     shown that survival of HSCT is profoundly impacted by the patient's pre-transplant disease     status. Primary infections with viruses such as cytomegalovirus (CMV) and Epstein-Barr virus     (EBV) are common, and respiratory viruses such as adenovirus also frequently cause infection.     In patients with severe combined immunodeficiency (SCID), a prior study identified these     viruses as the most common causes of mortality in the immediate period following HSCT. Though     some forms of PIDD are amenable to HSCT without requiring conditioning chemotherapy, many     forms require a variable degree of pre-conditioning to ensure that stable engraftment of the     donor cells is achieved. The administration of cytotoxic chemotherapy used in the     conditioning regimens can however increase the risk for regimen related toxicity and for some     patients (especially those with active viral infections) this risk is particularly high,     leading to high treatment related mortality rates. For these reasons, many such patients are     not even considered candidates for HSCT or are delayed getting to HSCT and ultimately succumb     to infection before they can receive the transplant.      The primary objective of this study is to determine the safety of administering third-party     multivirus-specific cytotoxic T lymphocytes (mCTL) from adult CMV seropositive donors to     treat refractory viral infections in patients with primary immunodeficiency disorders (PIDD)     prior to hematopoietic stem cell transplantation (HSCT).   "
59221|NCT02510391|"     This nonrandomized pilot study is investigating the efficacy of a modularized treatment for     anxiety in children ages 3-7 years old. Eligibility is determined at a baseline assessment,     followed by a second baseline assessment one month later. The treatment protocol,     Parent-training Intervention for Preschoolers with Anxiety (PIPA), is flexible and allows for     individualized treatments based on a treatment algorithm, ensuring that sessions address the     most pressing clinical needs of each child. Treatment consists of weekly 60-minute sessions     delivered over the course of 12 weeks. Symptom change is tracked weekly during brief phone     assessments and a post-treatment assessment will occur following the final treatment session,     approximately 12 weeks after starting treatment. Finally, all participants will complete two     follow-up assessments, occurring 1-month and 6-months after the final treatment session.   "
59222|NCT02510378|"     Patients with rectal cancer and resectable liver metastases receive short course     radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles     after 2 weeks.   "
59223|NCT02510365|"     The study is designed to assess the safety and efficacy of functional neural regeneration     collagen scaffold transplanted into acute spinal cord injury patients.   "
59224|NCT02510352|"     In accordance with national guidelines surgical repair of rotator cuff tear is the first-line     strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff     muscles and articular status. In appropriate situations, a satisfactory result is expected in     more than 80% of cases with a very good long-term outcome. On the other hand, the first-line     strategy in older patients is conservative as the main objective is the treatment of pain and     stiffness of the shoulder which can be achieved at least in the short-term with general and     local medications and physiotherapy. In addition, poor prognostic factors such as massive     tears and muscle fatty infiltration or atrophy, are more frequently present in those     patients, leading to poor results of surgical treatment and a high risk of iterative tear     after repair.      Because of a lack of evaluation, there is currently no identified prognostic factor of     medical treatment and on the other hand no clinical situation in which a surgical repair is     mandatory. Therefore, investigator designed this study as an observatory with the follow up     of patients with a symptomatic rotator cuff tear treated conservatively.   "
59225|NCT02510339|"     The goal of this project is to determine the incidence of intra-articular knee pathology     following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical     exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial     nail via MRI.   "
59226|NCT02510326|"     The scaphotrapeziotrapezoid (STT) joint is a dome shaped joint in the radial wrist that is     important in transfer of load from the thumb and radial hand to the scaphoid and the     radioscaphoid and scaphocapitate joints. Arthritis in this joint is the second most common     degenerative arthritis in the wrist, reported in 15% of wrist radiographs. The true incidence     of arthritis in the STT joint however is unknown though we assume that most cases of     arthritis are not clinically significant. Furthermore, the clinical and biomechanical     significance of arthritis in this joint is unclear. The investigators' clinical impression is     that the incidence of STT joint arthritis is inversely related to that of radiocarpal joint     arthritis. In an ongoing study, we are examining the relationship between STT joint arthritis     and radiocarpal joint arthritis on radiographs.      We suggest that STT joint arthritis alters the biomechanics of the wrist by limiting movement     of the scaphoid within the STT joint thereby protecting the wrist from radiocarpal arthritis     by limiting instability of the scaphoid.      The specific aims of this pilot study are to evaluate the movement of the arthritic scaphoid     within the STT joint using a computer-generated model based on CT scan of the wrist and to     compare this model with the already established model of the normal STT joint.      The investigators' hypothesis is that there is significantly less motion in the arthritic STT     joint.   "
59862|NCT02502006|"     This research study will evaluate inter-individual variability in the response to the     non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen, among healthy adults.     It will also investigate what factors, like age, sex, or genetic background, cause this     variability.   "
59232|NCT02510248|"     This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study     in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be     assessed in healthy adult subjects and in adult subjects with CHC infection.      Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of     AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be     randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2     assigned to placebo), in a fasted state.      The planned dose-escalation scheme may be changed based on the emerging PK and safety data.     Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses     at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK)     profile, and the presence of an acceptable safety profile.      Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part     1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the     same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14     days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be     selected, however this depends on the evaluation of available PK and safety data from Part 1     of the study.      Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be     evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC     genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7     consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed     state. The treatment is anticipated to be administered in a once daily dose regimen or a     twice daily dose regimen. The dose and dose regimen to be administered will be determined by     the Sponsor depending on the PK and safety outcomes of previous cohorts.   "
72185|NCT02340897|"     The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of     nontuberculous mycobacterial lung disease based on chest computed tomography findings.   "
59236|NCT02510196|"     Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day -     Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding     of written English used in the questionnaires      Stage 1 - training The aims and requirements of the teaching program will be explained to the     participants at the start of the workshop. All participants will be given a sticker with a     number and a questionnaire numbered about current ultrasound practice which is numbered     according to participant number to allow for blinding. Anyone not wishing to participate can     either remove their sticker or not return the questionnaire at the end of the session. The     number on the questionnaire correlated to participant number. This will be recorded against     the participant name to allow for further follow up. All participants will rotate normally     throughout the sessions. At the end of the neuraxial session participants will be scored by     the session leader according to their ability to adequately carry out the procedure. Scores     will be correlated to participant number.      Stage 2 - assessment of skill retention      Following the training day participants will randomly be allocated into two groups. One group     will receive regular reminders to use ultrasound for all neuraxial anesthesias they perform     in the OR or labor ward. They will be reminded on a regular basis that ultrasound is a new     tool to assist them in performing neuraxial ultrasound. The other group with be allowed to     continue with their regular practice and will not receive reminders to use ultrasound for     neuraxial anesthesia insertion. Two months after the initial training day all participants     with be observed performing neuraxial anesthesia and re-assesed according to the original     scoring system. Each participant will be assessed 3 times over a 6 month period.   "
59237|NCT02510183|"     This study is to evaluate the effect of preoperative acupressure application on Postoperative     nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy in terms of     being in high risk group for PONV.   "
59238|NCT02510170|"     In this study, measurements of fetal and maternal head circumference will be collected. This     data will be presented in table or graph form. The effect of maternal head circumference on     fetal head circumference will be evaluated and presented in either formula or graph form.   "
59239|NCT02510157|"     This study aims to investigate the possible clinical effect of dexamethasone on the action of     sugammadex when it is administered to reverse deep neuromuscular blockade caused by     rocuronium in laparoscopic cholecystectomies.   "
59240|NCT02510144|"     Propionibacterium acnes is the most common pathogen identified from a surgical site infection     in the shoulder. Standard skin preps do not prevent this type of infection. Patients will     undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery.     Bacterial burden will be determined at the time of surgery.   "
59241|NCT02510131|"     To determine whether Hyacinth exercises are more effective than Kegel's exercise at improving     pelvic floor weakness among women aged 55 and above with urinary incontinence.   "
59242|NCT02510118|"     The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based     on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind,     multicenter clinical study.   "
59243|NCT02510105|"     The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive     Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).   "
59244|NCT02510092|"     This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical     coherence tomography and safety and efficacy of new generation fully bioresorbable vascular     scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective     tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary     disease patients.   "
59245|NCT02510079|"     The primary purpose of this research study is to determine the safety of injecting ones own     Schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the     sciatic nerve has occurred.   "
59246|NCT02510066|"     This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic     cancer pain and then investigates its potential mechanism of peripheral blood.   "
59247|NCT02510053|"     To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients     after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40     patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in     this study. Caspofungin plasma concentrations are measured by using solid phase extraction     and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily     during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy     assessment (clinical and mycological responses) will be taken every 3 days by clinical and     mycological tests.   "
59248|NCT02510040|"     The purpose of this study is to describe clinical characteristics, treatments, and one-year     outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle     hypertropia.   "
59249|NCT02510027|"     While there is broad consensus that HR-HPV detection is the best available primary screening     test, there is no agreement about the most efficient and reliable triage procedure for HR-HPV     positive women. Transient HR-HPV infections are very common, and the vast majority of these     infections spontaneously regress after a year or two. Only a small fraction of cases will     lead to persistent infection responsible for cervical neoplasia. The FRIDA Study is a large,     population-based study that was designed to evaluate the performance and cost-effectiveness     of different triage strategies for hrHPV-positive women in Mexico.   "
59250|NCT02510014|"     A multi-center, open-label, long-term safety study in which approximately 600 subjects     diagnosed with opioid use disorder will be enrolled. Following a screening period, all     subjects will receive run in SUBOXONE sublingual film followed by monthly injections of     open-label high dose RBP-6000. RBP-6000 dose can be adjusted to low dose, and back to high     dose, based on the medical judgment of the Investigator. Subjects will participate in the     study for either 6 or 12 months.   "
59251|NCT02510001|"     This trial is designed to try two new cancer drugs together for the first time. The     investigators think that they might be effective in some types of bowel cancer. The first     part of the trial will see what doses of the two drugs can safely be given together. Once the     investigators have identified a suitable dose combination they will look at how effective     treatment is in bowel cancers where either the RAS gene is mutated, or MET is over-active. In     the trial the investigators will look at samples of blood, skin and tumour to check the drugs     are working in the way expected. The trial will take place in three sites in the UK and 5     sites in Europe. The trial is funded as part of the European commission's FP7 program.   "
59252|NCT02509988|"     The study aims to assess whether a nutritional drink taken before conception and continuing     through pregnancy, assists in the maintenance of healthy glucose metabolism in the mother and     promotes offspring health.   "
59253|NCT02509975|"     This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and     effectiveness study of OCL 503 in men with BPH.   "
59254|NCT02509962|"     To study the effects of an increased salt intake on metabolic, cardiovascular and     immunoregulatory functions in healthy men.   "
59260|NCT02509884|"     Comprehensive diagnosis and treatment of Alveolar Echinococcosis : A single-center, long-term     observational study of 312 Patients in Germany. Human alveolar echinococcosis (AE) is the     most Iethal human helminthic infection and is one of the 17 neglected tropical diseases     prioritized by the World Health Organization (WHO). Its incidence is low in endemic regions     of Central and Western Europe (0.03-0.05/100,000), but morbidity and treatment costs are     high. In this observational study, the investigators assessed the severity of the disease     using the PNM staging system and report on the long-term results of specific AE therapy in an     interdisciplinary team of clinicians.   "
59261|NCT02509871|"     This cross-sectional study of pathophysiology will bring additional informations on body     composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a     complementary study of Metaca study (AU882).   "
59262|NCT02509858|"     We investigated the effect of the administration of small doses of thyroxine to healthy     humans and patients with type 2 diabetes on postprandial forearm muscle glucose uptake,     insulin sensitivity indices, lipid metabolism, in vitro glucose uptake and GLUT4 recruitment     in the plasma membrane of monocytes.   "
59263|NCT02509845|"     The purpose of the clinical study is to evaluate the safety and bacterial impact of study     drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects.   "
59264|NCT02509832|"     COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess     Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute     Myocardial Infarction.      Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL     Proteus IVTM System into existing STEMI treatment protocols for subjects who present with     acute anterior myocardial infarction.   "
59395|NCT02508116|"     This is a randomized, prospective, open label study to determine the cost-effectiveness of     genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI)     with stent implantation, will be randomized either to genotype guided dosing of antiplatelet     therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine     CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.   "
59265|NCT02509819|"     The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a type of ankle foot orthosis designed to     reduce pain and improve function for individuals with foot/ankle pain and/or weakness.     Because the IDEO restricts ankle movement, the geometry and mechanics of the device must be     designed to allow for a smooth roll-over as the patient walks with the IDEO. The heel wedge,     while not physically part of the IDEO, is an integral part of the IDEO-heel wedge-shoe     system. The goal of this research is to determine how heel wedge properties may contribute     to the smoothness of roll-over during gait. Insight into the effects of heel wedge properties     on roll-over will help optimize the design of the IDEO-heel wedge-shoe system and may     produce guidelines for the customization of these features.   "
59266|NCT02509806|"     The purpose of this study is to assess the efficacy and safety of apatinib as maintenance     therapy after first-line chemotherapy in Postoperative Recurrence / Metastasis Progressive     Gastric Cancer.   "
59267|NCT02509793|"     The purpose of this research study is to see if tetrabenazine, which is commonly used to     treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in     patients with HD. Investigators will also see how the medicine affects aspects of thinking     and mood.   "
59268|NCT02509780|"     Vichy water is a type of spring water which traditionally comes from the famous spa town of     Vichy, France. The springs which feed Vichy carry a high amount of dissolved minerals.     Alkaline salts such as sodium bicarbonate are a primary ingredient in Vichy water, along with     calcium and magnesium carbonates.      Bicarbonates alkalinize urine, which is fundamental in preventing and/or diluting uric acid     crystals. These are the main component of the uric acid stones or even oxalate stones, which     generally  use  a crystal of uric acid as nucleus for stone formation. Cystine stones can     also be treated by alkalinizing urine.      Any disorder leading to a low urinary pH ( < 5.5 ) may predispose to stone formation. In this     context , the solution of uric acid and the prevention and treatment of uric acid stones can     be obtained by alkalization of the urine . The ideal alkalization is achieved when a urinary     pH of 6-6.5 can be reached.      The aim of this study is to evaluate the quantity of daily intake of the Vichy water     necessary to obtain this alkalization of the urine. There are no data available in the     literature about the relationship between the absolute quantity of Vichy water taken and the     urinary pH ; nor about the possible influence of the Body Mass Index on this relationship.   "
59269|NCT02509767|"     This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate     (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient     populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible,     and acceptable for women and adolescents. A total of 400 female patients (ages 15-44)     requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration     (usual care). Subjects will be followed for one year. The primary study outcome is DMPA     continuation at one year by self-report in both study arms. Secondary outcomes include     patient-reported satisfaction with treatment; satisfaction with home use; and costs     associated with contraceptive care. The investigators hypothesize higher continuation rates     among self-injection users compared to patients who receive standard care. Secondary     exploratory hypotheses include higher patient satisfaction and lower costs associated with     contraceptive care among self-injection users.   "
59281|NCT02509611|"     The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e.     reduction-oxidation [redox] status); motor function; and psychosocial well-being, and the     feasibility and acceptability of implementing a Hatha yoga program in PD subjects.   "
59282|NCT02509598|"     Open label, non-randomized, multi-center, within-subject comparative study to evaluate the     tolerability and the diagnostic utility of Lymphoseek and compared with VBD in pediatric     subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from     neonatal through 17 years.   "
59283|NCT02509585|"     Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of     lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single     dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.   "
72242|NCT02340143|"     The study is intended to assess the amount of crying and fussiness in infants fed an infant     formula containing probiotics.   "
59270|NCT02509754|"     Atrial fibrillation (AF) and congestive heart failure (CHF) are two epidemics that share     several physiopathological links. CHF patients present a significantly increased risk of     developing AF and the related detrimental hemodynamic effects are even more relevant than in     patients without CHF.      Within CHF patients rate control is the most widely used strategy to manage AF, having proved     non-inferior to rhythm control strategies. However, by this strategy, the hemodynamic effects     of AF persist, not contrasting the natural evolution towards progressive left ventricular     (LV) function, cardiac output , and symptoms worsening. Rhythm control strategy, instead, has     shown, in the general population, advantages over rate control concerning survival, quality     of life and thromboembolic events. The main limitation is that antiarrhythmic therapy used to     achieve this goal has several side effects, and that transcatheter AF ablation has been     assessed only in modest sample size studies.      Available literature focusing on a direct comparison between two specific management     strategies in patients with CHF and AF is limited to a small randomized study comparing     pulmonary veins isolation to AV node ablation and biventricular PM implantation (PABA-CHF     study). Additional indirect evidences may derive from meta-analyses of observational studies.      The investigators therefore designed this multicenter, randomized controlled trial aiming to     assess if, in recently diagnosed (less than 6 months) and optimally treated CHF patients with     impaired LV function, AF catheter ablation is effective in improving LV function and clinical     functional class, potentially driving to a reduction of device implantations (ICD/CRTs).   "
59271|NCT02509741|"     This research is aimed at verifying the effects of diets with high protein and low glycemic     index (GI) on weight management among overweight or obese Chinese adult. Additionally, the     investigators intend to verify the effects of two new approaches, including food replacement     and Internet-of-things (IOT) monitoring on weight control.   "
59272|NCT02509728|"     To explore the effects of enteral choline and DHA supplementation on plasma choline and     DHA-PC concentrations and metabolism, this randomized controlled study will assign 40 preterm     infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and     choline and DHA supplementation.      After 7 days of supplementation, a single dose of stable isotope labelled choline will be     administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels,     uptake and distribution of choline and DHA.      This study is designed to inform larger studies evaluating this approach of enteral     co-application of choline and DHA on clinical important outcomes.   "
59273|NCT02509715|"     Effect of intraoperative nerve monitoring on voice quality during thyroid surgery      Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and     endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable     decrease in the complication rates. In case of these advances, patients still have fear     related with their voice. In this study, investigators aimed to investigate voice changes     during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.   "
59274|NCT02509702|"     This study evaluates the effect of the mobile phone intervention 'Connected to Care' on the     attendance rate to cervical cancer screening check-up appointments.   "
59275|NCT02509689|"     A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified     that can overcome an existing barrier to the use of neurofeedback as a treatment technique in     a military setting. Neurofeedback, or EEG Biofeedback, is a form of biofeedback that uses the     brain's own electrical activity as the training parameter. With sufficient practice, the     brain can learn to change its own activity through finely tuned feedback using computerized     sounds, graphs and animations. Previous attempts at using neurofeedback as a treatment     modality have been subject to a lack of standardization and have required significant     expertise on the part of the provider. This new GZNT technology allows neurofeedback to be     administered in a standardized and semi-automated fashion, which, if effective, will     represent a significant advance toward providing this promising treatment modality to Service     Members in a military or VA setting. This study will determine feasibility and preliminary     evidence of efficacy for this neurofeedback technology in a pilot study of soldiers with     medical issues associated with Traumatic Brain Injury (TBI). GZNT technology has the     potential to provide a cost-efficient, non-invasive/non-pharmacological approach to recovery     from impact and/or blast-induced brain injury, and holds promise to simultaneously address     emotional symptoms that are often a part of the post-concussion symptom picture.   "
59276|NCT02509676|"     The purpose of this study is to investigate the effects of a 5-week dynamic stretching     exercise training on muscle-tendon unit of gastrocnemius muscle.   "
59277|NCT02509663|"     The sinuplasty balloon offers a more physiological first of the sinuses which minimizes risks     associated to traditional surgery. Its atraumatic characteristic also helps to reduce the     risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative pain,     ensure faster return to daily life activities (reduction of the average length of     hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and     reduction of post-operative pain score seams decrease on EVA.      The economic impact of the sinuplasty balloon appears very favourable and fits into the     strategy of development of the ambulatory practice.   "
59278|NCT02509650|"     The primary purpose of the protocol is to use next generation sequencing to identify     pathogenic variants in genes involved in very rare skin diseases.      The secondary purpose will be to study the genotype-phenotype correlation in order to     re-evaluate the classification of these disorders. This work could help in the understanding     of the physiopathology of very rare skin disorders.   "
59279|NCT02509637|"     Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of     bronchi caused mainly by the perpetuation of inflammation and impaired clearance of     secretions. Physical therapy is essential in the treatment of these patients, using its     various techniques and devices. The aim of this study is to evaluate the impedance of the     respiratory system, by impulse oscillometry, after breathing exercises with chest compression     or flutter in patients with bronchiectasis, considering that there are no results in the     literature on the effect of these techniques in the small airways of these patients.   "
59280|NCT02509624|"     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of GS-4997 in     adults with impaired hepatic function relative to matched, healthy controls. Each participant     in the control group will be matched to a participant with impaired hepatic function by age     (± 10 years), gender, and body mass index (± 20%).   "
59284|NCT02509572|"     The goal of this trial is to test a novel means of collecting patient-entered sexual health     information for the provision of clinical decision support to increase the testing and     detection of sexually transmitted infections (STI) in adolescent emergency department (ED)     patients at high risk for STIs.   "
59285|NCT02509559|"     The main objective of the present study is to combine two lines of research, investigating     the interaction between emotional processing and memory performance (on both behavioral and     electrophysiological levels) and its modulation by ß-blockade.      Concerning pharmacological manipulations with ß-blockers, there are no studies, which     investigated the effects of propranolol on electrophysiological (ERPs) and behavioral     measures of recognition memory along with their codependence on individual variations of     adrenergic receptors' polymorphisms. Till now, also the findings about genetic influences of     ADRB1 and ADRB2 on recognition memory for emotional contents are lacking.      Therefore, the current investigation has been designed to replicate the former results which     revealed reduced ERP correlates of recognition memory for emotional pictures due to     administration of ß-blocker propranolol. Furthermore investigators goal is to test, whether     there are any differences between carriers of genetic variants of the ADRB1 and ADRB2 in     memory performance and/or changes in event-related potentials and in propranolol influences     on the above mentioned processes.      In conclusion, investigators hypothesize: (1) a memory advantage of emotionally arousing     stimuli over emotionally neutral pictures; (2) more pronounced ERP components (EPN, LPP,     old-new effect) associated with encoding and memory for emotional stimuli; (3) a reduction of     electrocortical correlates of emotional recognition memory (old-new effect) caused by     propranolol; (4) a potential impact of genetic variants of the ADRB1 and ADRB2 on the     emotional information processing and memory formation alone, and on the propranolol     modulation of those processes.      Furthermore, investigators hypothesize additional pharmacodynamic effects of propranolol such     as influence on skin- conductance, pulse waves, burdening heart frequency, pulmonary function     and metabolomics, which might depend on the ADRB1 and ADRB2 genotype.   "
59286|NCT02509546|"     This phase I/II trial studies the side effects and best dose of 8-chloro-adenosine and how     well it works in treating patients with acute myeloid leukemia that has returned after a     period of improvement (relapsed) or has not responded to previous treatment (refractory).     Drugs used in chemotherapy, such as 8-chloro-adenosine, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading.   "
59396|NCT02508103|"     This research study will look at brain and symptom differences among women with severe     premenstrual mood symptoms. One goal of this study is to look at the effects of taking a     nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in     emotion regulation while viewing pictures during a neuroimaging (fMRI) session. The     investigators will also look at whether oxytocin improves premenstrual mood symptoms.   "
59287|NCT02509533|"     To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus     usual dressing method. The VAC Therapy system consists of:        -  A unit delivering a precise under atmospheric pressure, controlled and regulated in the          wound site,        -  Consumables necessary for the implementation of the dressing,        -  Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It          is known to be efficient into care of chronic wounds and ulcerous wounds by increasing          the cicatrisation.      This system is systematically used into the dermatology unit of the CHU of Saint-Etienne     after transplants of leg ulcers, but no data confirms the interest of this method compared to     usual dressing method. This study will provide this data.   "
59288|NCT02509520|"     Elderly patients who experience a prolonged ICU stay are at high risk for developing post     intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle     mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic     disability, prolonged mechanical ventilation and the need for costly extended stays in long     term care facilities (LTCs). The investigators' preliminary study shows attempts at     rehabilitating patients who have already developed PICS are minimally effective, resulting in     only modest improvements in functionality. This project will determine the effects of     mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation     (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing     PICS related musculoskeletal and functional deficits, and improving clinical outcomes.   "
59289|NCT02509507|"     This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene     laherparepvec, injected intrahepatically, into liver tumors with known progression in     subjects with Hepatocellular carcinoma and subjects with liver metastases from breast     adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or     squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell     carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation     consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in     increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose     determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated     separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be     deemed safe for non-hepatocellular carcinoma subjects before it will be administered in     hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the     Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A     (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects     for each tumor type.   "
59290|NCT02509494|"     The purpose of this study is the evaluation of the safety and immunogenicity of two candidate     Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen.   "
59291|NCT02509481|"     The purpose of this study is to determine whether repeated ivermectin mass drug     administrations to Burkinabé villagers, performed in three week intervals over the     rainy-season, is well-tolerated and safe, and also effective in reducing local malaria     transmission and thus clinical malaria episodes in treated village children.   "
59318|NCT02509130|"     MISSION is a new and novel way of delivering highly specialised asthma care and has the     potential to change the way asthma care across the United Kingdom (UK) is delivered as well     as services for other long term health conditions. The MISSION model is the first model of     this type and the current research study aims to evaluate its success and to compare the     MISSION service to current care delivery. This will be done in several different ways. The     study is a mixed methods evaluation of the new service comparing outcomes before and after     the intervention using retrospective data analysis and prospective qualitative interview. A     control arm of patients not exposed to, but eligible for, the new intervention will also be     included. The study will be conducted at Portsmouth Hospitals National Health Service (NHS)     Trust and will recruit patients who attended MISSION clinics, outpatient asthma clinics,     staff who attended MISSION clinics in a professional capacity and patients from GP surgeries     where MISSION clinics were held who did not attend.   "
59292|NCT02509468|"     The most recent classification, adopted by International Society for the Study of Vascular     Anomalies (ISSVA) in 1996, and updated in Melbourne in 2014, divides these lesions into two     broad categories: vascular tumors and vascular malformations. Vascular malformations (VMs)     are subdivided into high-flow VM and slow-flow VM.      Slow-flow VMs consist of congenital anomalies which may involve abnormal capillaries vessels,     venous vessels, lymphatic vessels or combination of several of them. They can be superficial     (involving cutaneous and subcutaneous tissues) and/or may have visceral involvement. They can     be limited or diffuse, and are sometimes components of genetic hypertrophic syndromes.      The diagnosis of slow-flow VMs is performed on physical examination (biopsy may be required     for confirmation), and is completed with imaging (ultrasonography and magnetic resonance     imaging (MRI)). Slow-flow VMs may be particularly voluminous; associated with underlying     hypertrophy responsible for functional impairment; painful; associated with seepage or     continuous cutaneous bleeding; complicated with visceral signs or hematologic disturbances     (anemia, thrombopenia). Management requires dedicated multispecialty care. There are no     guidelines for treatment, and management may include no intervention - but natural history of     these VMs is progressive worsening -, compression by physical bandage, sclerotherapy,     resection (when feasible),anti-inflammatory or anti-coagulation drugs.      Case reports and series have provided evidence for supporting the need for a clinical trial     of sirolimus by reporting successful treatment on several children with complicated vascular     anomalies. The choice of sirolimus is rational. Mammalian target of rapamycin (mTOR) is a     serine/threonine kinase regulated by phosphoinositide-3-kinase involved in cell mobility,     cell growth and angiogenesis. Sirolimus inhibits mTOR, which induces inhibition of     angiogenesis, in particular lymphangiogenesis, which has been demonstrated in several models.   "
59293|NCT02509455|"     To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand     management purposes), has the same trunk sway measures similar normal reference values of     SwayStar. Offline data analysis of data obtained from Sensoro will be compared to data     obtained by SwayStar, a highly accurate and widely accepted system for measuring balance     control.   "
59294|NCT02509442|"     This study is about an experimental biomedical monocentric search concerning twelves patients     presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on     the site of the CHU of Montpellier.      The objective of this search is to understand exactly how the electric impulses, delivered by     the neurosurgeon to make a functional mapping of the brain during the surgery awakened by     tumors infiltrates of low rank, propagate in this one and to identify the nervous networks     inhibited by these electric impulses.      Having verified the eligibility of the patients and having obtained their consent, they will     be included in the study. Before the beginning of the surgery, the electroencephalography     activity of the brain of every patient will be recorded. Before and after the surgical     resection, the electrocorticography activity will be recorded.      The collected data will then be analyzed, after the operation. Analyses will try to identify     what we call potential evoked by the stimulation and which are small electric waves which     appear after the electric stimulation was delivered.   "
59295|NCT02509429|"     The objective of this study is to assess the efficacy of an Artificial Pancreas system which     includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold     Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical     centres. After a 2 week run-in period, they will attend two investigational sessions of 65     hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will     be activated, depending on the randomization. The main endpoint is the time spent below     70mg/dL between 22:00 and 07:00.   "
64347|NCT02443402|"     The purpose of this study is to compare sitagliptin and placebo for the prevention of high     blood glucose during surgery.   "
59296|NCT02509416|"     The establishment of a number of training programs in therapeutic endoscopy, standardization     of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde     cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The     length of training and minimum number of procedures, requisite theoretical learning and     methodology to define competence in EUS and ERCP are not well defined. The investigators     research has demonstrated that individuals in training acquire skills at different rates and     the number of procedures completed alone is a suboptimal marker for competency in a given     procedure. Hence, emphasis needs to be shifted away from the number of procedures performed     to performance metrics with well-defined and validated thresholds of performance. Multicenter     prospective data are needed to help guide development of competency based medical education     that define learning curves in EUS and ERCP and set evidence-based benchmarks required to     achieve competence using a validated competency assessment tool.      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment     tool will allow for reliable and generalizable standardized learning curves, competency     benchmarks and creation of a centralized national database that compares a trainee's     performance amongst peers.   "
59297|NCT02509403|"     The purpose of this study is to assess the safety (absence of skin irritation) of a feminine     hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. The     feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.   "
59298|NCT02509390|"     Assessment of the evolution of fibrinogen plasma level within the first ten days after major     trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to     onset.   "
59299|NCT02509377|"     Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of     Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout     the United States. These criteria state exclusion for hypertension and diabetes which are     known co-morbidities for obesity. Investigators plan to expand one exclusion criteria for     open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of 35.0 and     greater.Investigators will maintain all other inclusion and exclusion criteria (including     excluding for hypertension and diabetes) with the exception of expanding the BMI to include     mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be compared to     the comorbidities of the mothers published in the MOMS trial.   "
59319|NCT02509117|"     The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979     following oral doses in healthy adult and healthy elderly subjects.   "
59322|NCT02509078|"     This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a     patient with acute respiratory distress syndrome will improve survival. Half of the patients     will receive a neuromuscular blocker for two days and in the other half the use of     neuromuscular blockers will be discouraged .   "
61820|NCT02476422|"     The study is designed to assess the efficacy and tolerability of diclofenac potassium soft     gelatin capsules compared with ibuprofen tablets in patients with moderate to severe     postoperative dental pain.   "
59300|NCT02509364|"     Idiopathic pulmonary fibrosis (IPF) is a highly heterogeneous and lethal pathological process     with limited therapeutic options, which is the most common and severe of the idiopathic     interstitial pneumonias (IIPs). During the past 20 years, the incidence of IPF increased     significantly. Most of IPF patients show a median survival time of 2-3 years after diagnosis.     Five-year survival rate is 30%-50%. It's difficult to diagnose in the early stage of IPF.     Once the patients go to hospital, it's already in the late stage. Now there is no effective     therapy except lung transplant for IPF in clinical application.      Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a fatal condition with high     mortality (over 80%). Its etiology and pathogenesis remain unknown. There is a lack of     effective treatment for it. Based on the investigators' long-term clinical observation, most     cases of AE-IPF initially got common cold and had coryza, more cough, nasal     obstruction，rhinorrhea, sore throat, some patients had fever, headache, and etc. Some of     these patients' condition developed very rapidly and then became very severe similar to the     situation of acute respiratory distress syndrome (ARDS). Why these AE-IPF patients were so     hypersensitive to cold? What were the immunologic and pathological mechanisms of their lung     lesions after patients exposed to common cold? How to effectively offer interventional     treatment for AE-IPF? All the above questions are yet to be explained clearly.      In the investigators' previous retrospective study, the investigators found that there were     some obviously imbalanced immune responses in IPF patients, including increased cluster of     differentiation 4 (CD4) T cell population, immunoglobulin and complements. The investigators     also found highly expressed inflammatory cytokines (IL-17, MIG and IL-9) and high detection     rates of pathogens in AE-IPF patients, especially serum immunoglobulin M (IgM) antibody of     some respiratory virus. These findings provide a strong suggestion that there are some     imbalance of immunologic function in IPF and there are relationship between AE-IPF and     infection, especially Cold virus infection might be a key trigger for AE-IPF.   "
59301|NCT02509351|"     -  Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects          on either mother or baby.        -  The aim of the this study is to address if there is any benefits 'regarding the          intra-operative blood loss' from preoperative rectal administration of 400 mic of          Misoprostol in addition to the routinely administrated 10 units of oxytocin   "
59302|NCT02509338|"     The main objective of the trial is to study the technical feasibility of the implantation of     a new electrode Monocontact deep brain stimulation electrode in dystonia.   "
59303|NCT02509325|"     The purpose of the study is to investigate the feasibility of using the commercially     available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor     fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of     motor fluctuations would support the general neurologists in the referral of PD patients to     the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility     evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers.   "
59304|NCT02509312|"     This is a randomized, double blind placebo trial to evaluate whether ketorolac given at the     time of cord clamp has any impact on post-partum pain control. Patients will be randomized to     either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive     ketorolac at cord clamp and 3 additional doses 6 hours apart (total 4 doses/24 hours). Those     in the placebo group will receive placebo medications during those time periods.   "
59305|NCT02509299|"     Chronic obstructive pulmonary disease (COPD) impacts negatively on the quality of life of     patients. Several studies have shown that acute exacerbations (AEs) decrease health-related     quality of life, pulmonary function and survival of COPD patients.      The objective of the present study is to examine the effects of a physical therapy program on     perceived health status in COPD patients hospitalized due to an acute exacerbation.   "
59306|NCT02509286|"     The trial is designed to investigate differences in outcome of patients with esophageal     adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant +     adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation     (CROSS) plus surgical resection.   "
59397|NCT02508090|"     Genotype 1 CHC participants from Study SPC3649-207 with null response to prior     pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension     study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen     monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an     investigational product.   "
64429|NCT02442336|"     The overall goal is to develop and examine the acceptability of a web-based (Internet)     intervention program for patients with head and neck cancer who have recently completed     radiation therapy.   "
59307|NCT02509273|"     Closed1 aims to compare the efficacy, safety and pharmacokinetics of clonidine     (hydrochloride) to midazolam in the sedation of ventilated children and adolescents (0-18     years) admitted to a paediatric intensive care unit (PICU) and requiring mechanical     ventilation and sedation for at least 24 hours.      In particular, the proportion of subjects with sedation failure at the maximum possible dose     (defined within the study protocol) will be measured. Additionally, the safety and     tolerability (including withdrawal effects) of clonidine compared to midazolam will be     evaluated. A pharmacokinetic-pharmacodynamic relationship of clonidine for sedation in PICU     will be established. Genetic polymorphisms of clinical relevance affecting pharmacokinetics,     pharmacodynamics and metabolism will be also identified.      Ad hoc paediatric parenteral formulations of clonidine hydrochloride and midazolam will be     manufactured. At least 300 subjects will be enrolled from study centres in five European     member countries (Czech Republic, Germany, Italy, the Netherlands, and Sweden).      The clinical study will enrol critically ill paediatric patients who require mechanical     ventilation and sedation.      Subjects will be closely followed using standard PICU monitoring of vital functions     (continuous assessment of heart rate and peripheral arterial oxygen saturation, intermittent     assessment of systolic and diastolic blood pressure), intermittent assessment of pain and     depth of sedation, documentation of parameters of mechanical ventilation and intermittent     arterial blood gas analysis.      The study will be conducted in compliance with the study protocol, Good Clinical Practice     (ICH-GCP) and the applicable regulatory requirement(s). In addition, qualified PICU staff     will be monitoring subjects around the clock, thus minimising reaction time in case of alarms     or deterioration of clinical parameters.      This project has received funding from the European Union's Seventh Framework Programme for     research, technological development and demonstration under grant agreement n° 602453.   "
59320|NCT02509104|"     The primary objective of this study is to determine the bioavailability of a FDC capsule     formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative     to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in     healthy male subjects in fed and fasted states. This is an open-label, randomized, single     dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1)     and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride     0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the     coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period.     Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive     treatment under fasted or fed conditions) and will participate in both treatment periods. The     two treatment periods will be separated by a minimum washout period of 28 days. The total     duration in the study for each subject will be approximately 2.5 months from screening to the     final follow-up visit.   "
62401|NCT02468830|"     The objective is to evaluate the efficacy and safety of mirabegron to treat urinary     incontinence in children with Overactive Bladder that are refractory and/or intolerant to     antimuscarinics.   "
59308|NCT02509260|"     Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and     Medicaid Services introduced the Surgical Care Improvement Project infection project with the     aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous     antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic     selection, discontinuation of prophylactic antibiotics within 24 hours after surgery,     appropriate hair removal, and maintenance of perioperative normothermia. Despite the     enforcement of these measures through quality reporting and pay-for-performance measures,     significant controversy exists as to their overall effectiveness, especially in the high-risk     colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in     the colorectal population; however, not all patients are appropriate candidates for this     approach and the inability of promising interventions such as wound edge protection and     gentamicin sponges to improve SSI rates following colorectal surgery mandate the     investigation of novel techniques.      The aim of the current study is to assess the clinical effectiveness of incisional NPWT to     reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study     is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints     include length of hospital stay and cost effectiveness.   "
59309|NCT02509247|"     Wireless telemonitoring was used during the habituation phase of continuous positive airway     pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated     either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time,     patient satisfaction and treatment efficiency and efficacy were compared between the groups     at baseline and after one year treatment the CPAP adherence and treatment efficacy were     recorded.   "
59310|NCT02509234|"     The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have     been treated with a combination therapy of trabectedin and irinotecan (within compassionate     use), to determine, if this is a promising treatment option with acceptable toxicity and if     the results warrant a prospective study.   "
59311|NCT02509221|"     Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with     Sevoflurane. Restless recovery from anesthesia may not only cause injury to the child or to     the surgical site, but may also lead to the accidental removal of surgical dressings, IV     catheters, and drains. is one of the The purpose of the study is to find whether duration of     exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.   "
59312|NCT02509208|"     The purpose of this European study is to demonstrate the safety and performance of the     SurgiClot® dressing in the treatment of cancellous bone bleeding.   "
59313|NCT02509195|"     The purpose of this study is to identify the effects that ageing may have on the drug levels,     the safety and the efficacy of Dolutegravir.      These effects will be measured in people who are aged 60 or over and taking antiretroviral     therapy for HIV infection.      Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs     called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and     Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data     available on Dolutegravir in the context of older age. The HIV population is ageing and the     investigators know that older age can significantly change the effects and side effects of     medications, including that of antiretrovirals.      The investigators aim to investigate the treatment outcomes in older people taking     Dolutegravir including the tolerability, efficacy and safety of the drug.      The study will also assess the quality of life (wellbeing of individuals) and cognition     (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this     study may inform treatment choices and monitoring in this population in the future.      The duration of involvement in the study will be 6 months with an additional screening visit     and a checkup visit 10 days after end of study visit.   "
59314|NCT02509182|"     The purpose of this study is to test the hypothesis that decreasing the inspired oxygen     concentration during thoracic surgery requiring one lung ventilation will improve     post-operative oxygenation.   "
59315|NCT02509169|"     An open-labeled, randomized, active-controlled phase II study to investigate clinical     efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with     p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).   "
59316|NCT02509156|"     The primary purpose of this study is to examine the safety and feasibility of delivering     allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer     survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced     cardiomyopathy (AIC).      The secondary purpose of this study is to obtain preliminary evidence for therapeutic     efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV     dysfunction secondary to AIC.   "
59408|NCT02507947|"     SPECTAmel is a standardized, quality-assured molecular screening platform for tumor     characterization and storage of human biological material (HBM) for the purpose of     integrating new biomarkers into clinical trials and optimizing access of patients to     therapeutic biomarker-driven clinical trials. HBM and clinical/pathological data are     collected from consenting patients.   "
59317|NCT02509143|"     Objectives: This study aims to assess the effectiveness, safety, and feasibility of intensive     acupuncture treatments combined with standard antiemetic medication as compared with P6     acupoint stimulation combined with standard antiemetic medication or with standard antiemetic     medication alone, to prevent postoperative nausea and vomiting (PONV) in patients undergoing     laparoscopic colorectal surgery.      Background: PONV is one of the prevalent discomforts in the early phase of recovery after     surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the     occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces     more benefits compared with P6 stimulation alone or whether acupuncture combined with     standard antiemetic medication yields better outcomes. This study aims to assess the     effectiveness and safety of different acupuncture regimen for the prevention of PONV:     high-dose acupuncture treatments combined with standard antiemetic medication, P6     acupuncture-point stimulation combined with standard antiemetic medication, or medication     alone.   "
59321|NCT02509091|"     The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of     bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy     and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with     Acute Exacerbation of Bronchiectasis.   "
59323|NCT02509065|"     The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon     usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic     pancreas, and determine whether there is a target at which adequate glycemic control is     achieved by an insulin-only bionic pancreas with minimal hypoglycemia.   "
59324|NCT02509052|"     This phase I/II trial studies the side effects and best dose of leflunomide in treating     patients with multiple myeloma that has come back (relapsed) or has not responded to previous     treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.   "
59325|NCT02509039|"     To determine the safety and tolerability of CC-122 when administered orally to adult Japanese     subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL) and to define the maximum     tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).   "
59326|NCT02509026|"     The purpose of this study is to study the benefits and risks of etanercept withdrawal in     patients who have achieved a significant clinical response.   "
59327|NCT02509013|"     This is a prospective, multi-center, hospital-based observational study. The aim of the study     is to evaluate the prevalence of chronic kidney disease in patients with stable coronar heart     disease.   "
59328|NCT02509000|"     This study aimed to assess the impact of air filtration on indoor air quality and     cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.   "
59329|NCT02508987|"     The aim of the study is to evaluate the effect of obesity on periodontally healthy or     diseased tissues.Normal weight and obese subjects were analyzed in 6 groups. Clinical     periodontal status was determined through plaque index, gingival index, bleeding on probing,     pocket probing depth, clinical attacment level and radiographs.      Oxidative stress is known to contribute to various diseases by affecting cellular functions     through the oxidation of proteins, lipids and DNA. Oxidative stress can be assessed by     measuring the products of oxidative damage found in proteins, lipids and DNA or reductions in     total antioxidant capacity Malondialdehyde, protein carbonyl and total antioxidant capacity     levels are biomarkers of oxidative stress in gingival crevicular fluid.   "
59330|NCT02508974|"     Malnutrition of patients on admission to hospitals are estimated to be as high as 60%,     although the prevalence varies between countries. The impact of malnutrition on patient     recovery and discharge is severe, with extensive cost implications. This study aims to assess     the prevalence of at risk for malnutrition among adult patients admitted to hospital across 3     countries on the African continent.   "
59425|NCT02507726|"     This study evaluates the performance of a new 1-piece ostomy convex appliance in patients     with enterostomy.   "
59331|NCT02508961|"     The study will be a pragmatic, single blind, randomised, controlled feasibility study,     comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS.     The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and     Arran, NHS Lothian, and Plymouth Hospitals NHS Trust.      The aim of this study is to assess the feasibility of a randomised controlled trial examining     the effectiveness of a six-month web-based physiotherapy programme and usual care compared to     usual care alone, in people moderately affected by MS and to gather essential information for     the planning of a definitive trial, which would evaluate both clinical and cost effectiveness     of the intervention.   "
59332|NCT02508948|"     To further examine current intubation practice among critically ill patients who are in need     of endotracheal intubation, the investigators plan to perform a prospective cross-sectional     study of adult critically ill patients who needed endotracheal intubation at participating     sites between August 1st, 2015 to August 1st, 2016. The investigators aim to describe the     current intubation practice among the participating sites with a description of complications     that may have surfaced during the peri-intubation period and to isolate predictive factors of     these complications.      In this study, the primary aim is to describe, through a prospective cross-sectional study,     the current intubation practice of adult critically ill patients undergoing endotracheal     intubations with secondary aims exploring complications that may emerge during the     peri-intubation period and to isolate predictive factors of these complications. This     information will generate hypotheses which will lead to further study with the ultimate     impact of reducing patient-related outcomes such as morbidity and mortality.   "
59333|NCT02508935|"     Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and safety     of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate to     severe acute pain. The study will assess the safety of administering multiple doses of     XARTEMIS XR in this population.   "
59334|NCT02508922|"     To build on a recent case study and open label trial, the investigators want to find out if     vitamin D supplementation can influence behavioural and core symptoms of autism.   "
59335|NCT02508909|"     Groin lymph node dissection for melanoma patients is burdened by high post-operative     morbidity, mainly related to wound. This is a prospective pilot trial investigated     feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in     patients with inguinal lymph node melanoma metastases.   "
59336|NCT02508896|"     Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel     group, phase I clinical trial of repeated administration by subcutaneous injection of a     single dose of one of two different proprotein convertase subtilisin/kexin type 9 targeting     AFFITOPE® vaccines or Placebo. This study will assess Safety, Immunogenicity and low density     lipoprotein cholesterol-lowering activity of the two vaccines.      72 healthy subjects are divided into three test groups (2 treatment groups, 1 placebo group),     each consisting of 24 subjects. The subjects are randomized to receive either of two     AFFITOPEs® (AT04A or AT06A, adsorbed to 1 mg aluminium oxyhydroxide) or placebo (1 mg     aluminium oxyhydroxide).      The study consists of 3 parts, part A, encompassing Visit 1 to Visit 8, covering 3 priming     immunizations at a dose of 15μg at days 0, 28 and 56 and the immediate observation period     extending to day 140; the prolonged observation period: part B, encompassing Visit 9 and     Visit 10 at days 273 and 365; and part C consisting of 7 visits (V11 to V17). Study     participants having received 3 priming vaccinations and having completed part B will receive     in part C one boost immunization at a dose of 75μg, which will be applied one year after the     3rd immunization (day 420). Probands will proceed directly from part A to part B and to part     C. Continuation of parts B and C will be considered based on the part A results, primarily     the immunological results. The following scenarios apply (provided that there is no safety     issue). None of the two treatment groups exhibits a vaccine-specific antibody response over     the placebo group at Visit 8 - this will lead to termination of the trial. One of the two     groups fails to exhibit a vaccine-specific antibody response over the placebo group at Visit     8 - this will lead to its discontinuation; the other treatment group and the placebo group     will be continued.   "
59337|NCT02508883|"     This is a prospective and observational study to evaluate oncologic patients that presented     upper gastrointestinal bleeding with the use of some prognostic scores.   "
59338|NCT02508870|"     This is a non-randomized, open-label, Phase 1 study of atezolizumab (anti programmed     death-ligand 1 [anti-PD-L1] monoclonal antibody) in intermediate/high/very high-risk     myelodysplastic syndromes (MDS) participants, as evaluated by the International Prognostic     Scoring System-Revised (IPSS-R). Eligible participants will either have never received     treatment with hypomethylating agent(s) (HMAs) or have relapsed or are refractory (R/R) to     prior HMA therapy. The primary objectives of this study are to determine the safety and     feasibility of atezolizumab therapy in these participant populations, including treatment in     combination with azacitidine.   "
59339|NCT02508857|"     Magnesium sulfate has been reported to improve postoperative pain, but evidence is still     controversial. Some studies demonstrated benefits while others concluded that there is no     efficacy. Aim: the aim of the study was to compare the effect of intravenous infusion of     magnesium sulfate to ketorolac during laparoscopic gynecologic oncology surgeries. Methods:     We designed a double-blind randomized controlled trial that compared intravenous magnesium     sulfate to ketorolac and saline solution in postoperative pain, morphine consumption and     opioid related side effects.   "
59340|NCT02508844|"     The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational     weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight     body composition of their infants.   "
59341|NCT02508831|"     The case of patients with amputation of forearm on one side and arm on the other is     particularly interesting to study because in this situation of handicap greater than a double     amputation in forearm. We should bring a functional benefit to the patient with the     transplant of forearm and this situation allows to have the best possible control to compare     the result of the transplant of arm to that of forearm because it is realized at the same     patient.      Amputation of both arms deprives patients of an elbow what establishes a major factor of     limitation of autonomy and makes patients totally dependent for the realization of the     essential gestures of the current life requiring the prehension (dress, dressing, food,     hygiene of the elimination). The various equipments are not always adaptable and usable.     Psychologically, an amputation in arm is unanimously considered as an infringement very badly     accepted of the physical integrity and establishes a major handicap factor of family,     professional and social exclusion.      The results of this study should allow a better appreciation of indications and modalities of     care of biamputed patients with at least one lesion level above the elbow.      This clinical research will determine the potential place of a reconstructive surgery as     allograft in biamputed patients on the basis of functional results and assessment of     disorders of the body schema perception.   "
59342|NCT02508818|"     There are no equivalent experiment setups to create comparable changes of gravitation such as     during parabolic flights. To determine the initial orthostatic responses of the     cardiovascular system under the gravitational conditions of mars and moon is an essential     step for a better understanding of 1) the fundamental functions of the human cardiovascular     system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels     in a spaceflight-context 3) approaches for countermeasure development against orthostatic     intolerance on moon and mars (applied research).      Non-invasive measurement methods will be used to achieve the cardiovascular key values of the     study: stroke volume (SV) and cardiac output determination by pulse contour analysis,     impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure     measurement, heart rate and heart rate variability determination by ECG. All of these methods     have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and     impedance cardiography are known to provide only relative SV and CO values. Thus inert gas     rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to     absolute values. Success of this procedure was shown during former parabolic flights.   "
59343|NCT02508805|"     The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for     injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard     therapy. The patients are randomised into two groups: standard therapy group and standard     therapy plus Neuromultivit group.   "
59344|NCT02508792|"     Heart failure (HF) is an important public health problem being considered an emerging     epidemic, therefore, strategies are essential to improve symptoms and to decrease the money     expenditure on healthcare. Based on the knowledge about the syndrome of heart failure, new     approaches are needed to decrease the symptoms, to enhance the quality of life of these     patients and highlight the non-pharmacological therapies such as the use of phototherapy. The     objective of this study is to study the effect of low level laser therapy in muscle function     and tissue oxygenation of the lower limbs in patients with heart failure. It is a randomized,     double-blind, including 20 individuals with heart failure, with stable, class II or III     according to the New York Heart Association (NYHA). It will be evaluated the acute effects of     a LASER intervention applied before a fatigue protocol throught muscle function and tissue     oxygenation in the participants. Evaluations will be performed by an isokinetic dynamometer,     near infrared spectroscopy (NIRS) and electromyography . It will be analyzed the     concentration of oxyhemoglobin and deoxyhemoglobin, total hemoglobin concentration, the     difference between these concentrations, muscular torque, fatigue index and muscle     activation. The data will be subjected to distribution normality test and if they have normal     distribution, the differences between the interventions will be checked by analysis of     variance, considering significant ap <0.05. If the data is non-parametric distribution will     be using the Mann-Whitney or Kruskal-Wallis. The SPSS 19.0 software will be used as a tool     for data analysis. The investigators expected to find as outcomes of this study an increase     in peripheral muscle function and tissue oxygenation and also a delay in the development of     muscle fatigue in patients with HF submitted to acute intervention with LASER.   "
59345|NCT02508779|"     Ineffective management of blood glucose (BG) levels during preconception and pregnancy has     been associated with severe maternal and fetal complications in women with type 1 diabetes     (T1DM). Preconception care emphasizing stringent glycemic control in the preconception period     and continued through early pregnancy can dramatically reduce these risks. However, the use     of preconception care in the US has been disappointingly low due to a variety of     organizational, provider, and patient centered factors. Furthermore, efforts to achieve tight     glycemic control can increase the risk of severe hypoglycemia (SH) in T1DM women, potentially     leading to serious health consequences. In this project, the investigators will test an     education based Internet intervention (Bump2be or Blood glucose awareness training (BGAT) for     users who might become pregnant) for use with T1DM women who are either actively trying to     become pregnant (TP) or planning to become pregnant in the 12 months following their     enrollment in this study (PP).      The main objective is to examine Bump2be's feasibility and preliminary efficacy as an     intervention for these women to better regulate their BG levels and to meet their     diabetes-related clinical targets for pregnancy. More specifically, Bump2be will be tested in     a randomized clinical trial in which 58 T1DM women who are either TP or PP will be recruited.     As part of this pre-post study design, participants will be randomly assigned to either the     Bump2be intervention (n=29) or the routine care group (n=29). Data collected will include     frequency of extreme BG, consequences of extreme BG, average BG levels (HbA1c level),     estimation of BG, detection of low and high BG, and psychological functioning (including fear     of hypoglycemia, avoidance of hyperglycemia, well-being, and internal locus of control).     Interviews with up to 10 trial participants will be conducted at the conclusion of their     study participation, to enable further optimization of the intervention in preparation for a     subsequent R01 submission. This will be the first study investigating the use of the Internet     to improve detection and management of extreme BG levels in Diabetes mellitus type 1 (T1DM)     women who are either TP or PP.   "
59346|NCT02508766|"     The primary purpose of this study was to examine the immediate effect of manual stimulation     on the foot plant in static and dynamic balance in young healthy subjects. In addition, the     secondary objectives of this study were: 1) to identify whether manual stimulation of the     foot plant in healthy young subjects, carried out with an easily reproducible protocol with     10 minutes duration, improves static balance, measured with Unipedal Stance Test; 2) to     assess whether, manual stimulation of the foot plant in healthy young subjects, carried out     with an easily reproducible protocol with 10 minutes duration, improves dynamic balance test,     measured with Star Excursion Balance Test.   "
59347|NCT02508753|"     The purpose of the study is look at the possible side effects of two different doses of     CXA-101/tazobactam, a low dose and a high dose, on participant's heart.   "
59348|NCT02508740|"     The purpose of this study is to characterize the effect of renal function on the PK of a 0.25     mg single oral dose of bevenopran in humans and to assess the safety and tolerability of     bevenopran in patients with varying degrees of renal impairment and in healthy subjects.   "
59349|NCT02508727|"     Cardiac exploration almost systematically requires the acquisition and / or calculating     function indices. The ejection fraction (LVEF) is probably based index most widely used in     all cardiac exploration methods. This relatively universal overall index has very many     qualities. LVEF is widely used in clinical practice through the exploration and monitoring of     all heart disease.      Current progress in the management of various cardiomyopathies pass through the detection of     early attacks. This testing often takes place upstream changes in LVEF that remains long     normal or normalized. Sensitive indicators capable of detecting early abnormalities of     regional functions are essential in addition to conventional echocardiography. Various     studies have shown the contribution of these new markers in early detection of abnormalities     of the cardiac function. The most widely used indicator in these studies because of its high     sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler     however has limitations in particular its dependence on the incident angle, which makes it     impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.      A new way of exploring the regional function of the heart, speckle tracking, can analyze     heart deformations along the principal axes of the heart. The advantage of this technique has     been shown in various pathological situations. Currently, this technique is mostly used in     longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this     technique is not currently known, acquisition of 3D technology is recent (2004) and dedicated     software is confidential dissemination and unvalidated.      The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In     the 90s, studies have demonstrated the feasibility of this technique, the ability to access     all of the myocardial deformation in space and to define normal values. The cost of the     procedure, duration, limited accessibility and post-processing very time consuming limited     the scope of the clinical benefits of this modality.      Echocardiography has major advantages over MRI, particularly its high availability, low cost     and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is     a new opportunity that it is essential to validate.      The main purpose of the study is to compare the strain values obtained 3D ultrasound to those     obtained by MRI tagged in a control group and a group of subjects with an anterior infarction     sequela.   "
59350|NCT02508714|"     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has     led to a significant reduction in morbidity. However, the first generation of these devices     had no positive impact on the mortality after PCI (compared to bare metal stents), which was     greatly attributed to a somewhat increased incidence of late and very late stent thrombosis.     Concerns about the role of durable polymers as a potential trigger of inflammation and     finally adverse events also led to the development of DES with bioresorbable coatings, which     leave after degradation of the coating only a bare metal stent in the vessel wall that does     not induce an inflammatory response. While such bioresorbable polymer DES are increasingly     used in clinical practice, data from head-to-head comparisons between bioresorbable polymer     DES with a contemporary highly flexible new generation permanent polymer coated DES.   "
59351|NCT02508701|"     This is a study testing what type of message and access influences a young male to get the     HPV vaccine.      The investigators are conducting a 2 X 2 design      These conditions are:        -  Condition 1: Altruistic personal with direct recommendation inside-dorm        -  Condition 2: Generic message with inside-dorm        -  Condition 3: Generic message with outside-dorm HPV vaccine        -  Condition 4: Altruistic personal with outside-dorm HPV vaccine      The objectives of this study are:      A. To examine the efficacy in encouraging young men to receive HPV shots at Time 1 within     each of the four intervention conditions (altruistic/personal with direct recommendation vs.     generic message) X (in-dorm vs. outside-dorm HPV vaccine).      B. To examine the efficacy in encouraging young men to receive HPV shots at Times 2 & 3     within each of the four intervention conditions (altruistic/personal with direct     recommendation vs. generic message) X (in-dorm vs. outside-dorm HPV vaccine).      2.1.1 List the clinical hypotheses. Objective A H A.1: At Time 1, college men who have     immediate access to the HPV vaccination will take the vaccination at a higher rate than those     who do not have immediate access to the vaccine.      H A.2: At Time 1, college men who receive an altruistic/personal health message along with     immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than the     men in the other three arms of the study.      Objective B H B.1: At Times 2 & 3, college men who have immediate access to the HPV     vaccination will take the vaccination at a higher rate than those who do not have immediate     access to the vaccine.      H B.2: At Times 2 & 3, college men who receive an altruistic/personal health message along     with immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than     the men in the other three arms of the study.   "
59352|NCT02508688|"     The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The     study will discuss the perioperative treatment, effectiveness, and morphology of     diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors     associated with increased three-month mortality in these critically ill patients will be     studied.   "
59353|NCT02508675|"     The major aim of this project is to investigate the prevalence, recovery patterns and risk     factors for health related quality of life functional, psychological, societal and economic     outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref)     questionnaire for the trauma population.   "
59354|NCT02508662|"     Objectives:      Primary Objectives:      To evaluate the anti-cancer activity of commercially available, targeted anti-cancer     therapies used off-label for treatment in patients with advanced solid cancer with known     genomic aberrations.      Secondary Objectives:      To determine outcomes of patients who were treated with matched targeted anti-cancer     therapies based on known genomic aberrations.      To obtain treatment related adverse events in patients with advanced solid tumor who were     treated with off -label targeted therapies.      To determine co-genomic aberrations that may contribute to treatment response or resistance     mechanisms.      To determine feasibility of detecting the genomic alterations in plasma, and the genomic     evolution of circulating biomarkers.   "
59356|NCT02508636|"     This is a phase II study to evaluate efficacy, safety, toxicity, and feasibility of the     addition of enzalutamide to leuprolide for a total duration of 24 months in patients with     very high-risk prostate cancer or pelvic node positive disease receiving radiotherapy. Very     high-risk prostate cancer is defined as 2 or more of the following characteristics: 1)     cT3a/b, 2) PSA ≥20 and <150, 3) Gleason 8-10, and 4) ≥33% core involvement.   "
59357|NCT02508623|"     The purpose of this study is to assess whether the add of Rifaximin in patients with liver     cirrhosis and esophageal varices treated with a standard therapy with beta blockers, leads to     a significant reduction of portal hypertension.   "
59382|NCT02508298|"     This is a prospective longitudinal study that will evaluate if changes (pre and post therapy)     in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen stiffness (SS)     as measured by acoustic radiofrequency impulse (ARFI) correlate with changes in portal     pressure as determined by the hepatic vein pressure gradient (HVPG) in patients with     compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.   "
59358|NCT02508610|"     This is protocol is generated in response to the exploratory R21 from the National Institutes     of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) for US-Russia     collaborative research in HIV/tuberculosis (TB). Given the exploratory focus of the protocol     and the short time frame of funding (2 years) we will study TB in Irkutsk, in Eastern     Siberia. Irkutsk is one of the hardest-hit areas in all of the Russian Federation for     drug-resistant TB and poor TB outcomes. Specifically, the investigators will examine the     factors of anti-TB drug pharmacokinetics, TB drug-resistance mutations and     virulent/transmissible M. tuberculosis sublineages. This foundational work will inform future     diagnostic strategies and therapeutic regimens.   "
59359|NCT02508597|"     Physicians play a critical role in reducing tobacco use by advising smoking patients to quit.     After receiving such advice to quit smoking, patients were more likely to report trying to     quit, quitting for at least 24 hours, making more quit attempts, and having more successful     quitting outcomes compared with those who received no such advice. On the other hand, most     physicians are not performing smoking cessation counselling, and miss the opportunities to     advise patients to quit smoking. One of the common reasons is the lack of time. Physicians     are busy and cannot afford even one minute to advice their patients to quit smoking. Other     barriers include lack of training and experience, lack of knowledge and skills, no awareness     about the benefits and effects of physicians' advice, no incentives and no support or     requirement from hospital management that they have to do it.      We designed a brief smoking cessation counselling model (AWARD) which takes only 10-20     seconds. We will train the physicians to perform the AWARD cessation counselling model in     clinic, and encourage them to participate in our brief smoking cessation intervention project     using the randomized controlled trail (RCT) design and to train more peer physicians to     perform brief smoking cessation counseling. We propose to investigate the effect of the     training program on physicians' knowledge of tobacco cessation, practice of performing     cessation counselling, and attitudes toward tobacco control policies.   "
59437|NCT02507570|"     This is an open label study designed to examine the effects of Enzalutamide with concurrent     administration of Radium Ra 223 dichloride in Castrate-Resistant (Hormone-Refractory)     Prostate Cancer subjects with symptomatic bone metastases in both the pre- and     post-chemotherapy setting.   "
59863|NCT02501993|"     The primary objective is to determine the early diagnosis rate and mortality rate of the     Nasopharyngeal Carcinoma (NPC) in the study population.      The secondary objective is to determine the incidence of NPC in the study population.   "
59360|NCT02508584|"     M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma     hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency     Investigational New Drug (eIND) 114686 following many prior treatments with standard     antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The     antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been     shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma     isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the     setting of immune deficiency, and in some cases resulted in cures. The investigators propose     to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB     Biotherapeutics), purify human antibody after vaccination, test the purified antibody in     killing assays to confirm potency, and then administer the purified human IgG to M. A. after     FDA compassionate use IND application and local Institutional Review Board (IRB) approval.   "
59361|NCT02508571|"     This is randomized controlled trial investigating the effects of direct swallowing training     and oral sensorimotor stimulation in preterm infants on oral feeding performance.   "
59362|NCT02508558|"     Previous studies have neglected two important aspects for the China National Space     Administration. First, while biomechanical models are very sensitive to the characteristics     of the subjects, data have been collected on subjects with biomechanical characteristics very     different from those of typical Chinese astronauts. Second, pure video analysis techniques     and kinematic data lack the necessary acceleration information important to understanding the     forces exerted during movement and control of human motion. While some studies used force and     moment sensors to aid in robot torque control and human joint work estimation, investigators     are unaware of any studies performed in a microgravity environment that have combined the     kinetic force and moment information with acceleration measurements to enable more reliable     motion tracking without the need for acceleration estimation.      This is why MICR0-G sensors and accompanying kinematic video system have been developed in     order to provide for detailed analyses of the astronaut movement control strategy (joint     forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques     permits us to calculate the joint and musculoskeletal dynamics required to execute the     microgravity motions, as well to provide insight into the altered movement strategies in     reduced gravity as compared to 1-G locomotion.   "
59363|NCT02508545|"     Parabolic flight is the only ground-based condition in which weightlessness (0G) can be     created long enough for safely testing changes in human perception and behavior. In addition     to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present     another unique opportunity to test the same responses to hypergravity and back to 1G.      Cognitive function, together with good oculomotor control, eye-hand coordination, and spatial     orientation perception, is a critical subsystem that is used by the CNS in the control of     vehicles and other complex systems in a high-level integrative function. Evidence from space     flight research demonstrates that the function of each of these subsystems is altered by the     transitions in gravito-inertial force levels. These neuro-vestibular alterations,     unfortunately, correspond to mission phases where physical and cognitive performance are     particularly critical for crew safety and mission success. To date, there is only limited     operational evidence that these alterations cause functional impacts on mission-critical     vehicle (or complex system) control capabilities. However, the true operational risks will be     estimable only after the investigators have filled the knowledge gaps and when the     investigators can accurately assess integrated performance in off-nominal operational     settings.      Accurate perception of self-in-space motion and self-motion relative to other objects are     critical to piloting, driving, and remote manipulator operations. Immediately after space     flight, most crewmembers have reported some degree of disorientation/perceptual illusion,     often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested     by lack of coordination, particularly during locomotion. Despite recent, intensive training,     some Shuttle landings were outside of the desired performance boundaries. Scores indicating     neurovestibular dysfunction in returning astronauts generally correlated with poorer flying     performances, including a lower approach and landing shorter, faster, and harder. An     underestimation of distance, coupled to an overestimation of tilt magnitude or misperception     of the type of motion, could be at the origin of these poorer performances.      This study should confirm that the unloading of the otoliths in weightlessness induces an     alteration in the egocentric reference during space flight. Errors in egocentric localization     might contribute at a higher level to the computation of misleading world-centered     representations, and therefore be partly responsible for illusory sensations and motion     sickness symptoms during space flight, and postural instability and oscillopsia after     returning in a reduced or terrestrial gravitational force level.      Beside their fundamental implications, the results of this study have also practical     implications in the design of man-machine interfaces. Changes in judgment of distance in     microgravity or in reduced gravity affect crew posture and reach, display orientation, and     other visual cues, which should be considered in hardware and operations design.   "
59364|NCT02508532|"     This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of     BLU-285, administered orally (PO), in adult patients with unresectable GIST or other relapsed     or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1)     and an expansion part (Part 2).   "
59365|NCT02508519|"     The aim of the study is to investigate how effective is zonal acupuncture method compared to     balance method to obtain a short coming pain relief effect, which takes place several minutes     after needle insertion.   "
59366|NCT02508506|"     This study will evaluate the effect of various degrees of renal function on the     pharmacokinetics and safety of ALKS 5461.   "
59383|NCT02508272|"     Discovery of differences in the host response in patients with systemic inflammation and     sepsis, and identification of novel, specific markers by using a longitudinal     clinico-transcriptomic approach.   "
59384|NCT02508259|"     This study is designed to test the safety and efficacy of a single, intravenous dose of     suramin in autism spectrum disorders (ASD).   "
59388|NCT02508207|"     To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 in     combination with ivacaftor (IVA) (VX-661/IVA) in subjects with cystic fibrosis (CF) who are     homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR)     gene.   "
59367|NCT02508493|"     Cognitive dysfunction is a highly persistent, pervasive and progressive abnormality in young     adults (i.e., 18-65 years) with MDD. It has also been shown that among adults with MDD who     are gainfully employed, measures of cognition are a greater determinant of overall workplace     performance than is total depression symptom severity. Several lines of evidence indicate     that cognitive deficits that persist between episodes of depression are critical determinants     of functional recovery in the workplace. The functional implications associated with     cognitive impairment provide the impetus for systematic evaluation, measurement and     assessment of the domains of cognition expected to be impaired in this patient population.      To date, no measurement tool has been sufficiently validated and/or determined to be     sensitive to the cognitive deficits in younger adults with MDD. Major limitations of     available comprehensive psychometric tools include relative lack of availability, cost, lack     of access to most healthcare providers, and above all else, the lengthy time to administer.     Moreover, the need for a psychometrist to interpret the results adds to the complexity and     the costliness of such an endeavor.      It is imperative that any tool recommended for clinical utility be aligned with the busy     nature of a high-volume clinical practice. The ideal gold standard tool for assessing the     presence of cognitive dysfunction in MDD in the clinical environment should include, but not     be limited to, features such as good conceptual coverage of cognitive domains affected in     MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture     effects and practice effects. The tool would also need to be brief, easy to administer and     interpret, and complement busy clinical practice.      This study is designed to validate a brief user-friendly tool capable of detecting deficit in     cognitive performance among adults with MDD. Data will be gathered with the aim to determine     whether the proposed tool identifies cognitive deficits in adults with MDD and differentiates     the clinical MDD population from healthy controls.      It is anticipated that the THINC-it tool will be free of charge and downloadable from the     THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be     accessible via computers/tablets, will take 20 minutes to self-administer in a clinical     setting, and the performance results will be immediately available.   "
59368|NCT02508480|"     We are conducting a randomized clinical trial (RCT) comparing the 10-week peer-led Photovoice     program to services as usual (SAU) at a large publicly funded community mental health agency     in Massachusetts. The control SAU condition will be enhanced with a 60-minute peer-led group     educational session about understanding and coping with prejudice and discrimination. The     10-session, peer-led Photovoice program, designed to empower individuals with serious mental     illness (SMI) to confront public prejudice and discrimination and reduce personal stigma     (self-stigma and perceived stigma), was developed and pilot tested at our Center, with     primary contributions from staff with a lived experience of mental illness. Development of     the Photovoice program was guided by an adaptation of the stress-coping model, informed by     recent research and conceptualizations of the effects of stigma on people with SMI. The     stress-coping model explicates the mechanisms by which public stigma about mental illness can     lead to personal stigma, which in turn has a negative impact on the person's mental health     and psychosocial functioning. This model also identifies critical factors that contribute to     personal stigma or protect against it, as well as more vs. less adaptive coping responses,     that are the primary focus of the Photovoice program.   "
59369|NCT02508467|"     This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic     activity of BLU- 554 administered orally in patients with hepatocellular carcinoma (HCC). The     study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2)     exploring both a once daily (qd) and twice daily (bid) dosing schedule.   "
59966|NCT02500654|"     The purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel     matrix derivative (Emdogain®, EMD) will have an additional effect on the healing outcome,     changes in the peri-implant microflora and on the inflammatory response in the periimplant     pocket at 12 months.   "
59370|NCT02508454|"     The Miami Heart Study at Baptist Health will be an observational, longitudinal and     prospective cohort study in a target population of 4000 healthy subjects (40-65 years old)     consisting of members from the Greater Miami Area (including eligible BHSF(Baptist Health     South Florida) employees). Baseline examination will consist of (1) assessment for     cardiovascular risk factors (including lifestyle and psychosocial factors); (2) screening for     subclinical atherosclerosis using Coronary CT angiogram, Coronary Artery Calcium (CAC)     testing, vascular 2D/3D ultrasound, endothelial function, arterial stiffness and (3) blood     sampling for determination of traditional risk factors, advanced omics and biobanking.     Participants will be followed yearly via telephone, email, or mail for change in health     status with a focus on cardiovascular disease events, including acute myocardial infarction     and other forms of coronary heart disease (CHD), stroke, and congestive heart failure;     mortality; and for cardiovascular disease interventions.      The Miami Heart Study at Baptist Health is expected to identify new imaging and biological     factors associated with the presence and feature of earliest markers of subclinical     atherosclerotic disease and provide opportunities for discovery/validation of novel     biomarkers to identify these high-risk features. This is expected to lead to advances in     understanding of evolution and progression of atherosclerotic cardiovascular disease starts     with an ultimate goal of establishing more personalized, evidence-based approach to medical     care.   "
59371|NCT02508441|"     This is a first-in-human, open-label, dose escalation and expansion, 2-part study to     determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in     patients with advanced unresectable solid tumors that are refractory to standard therapy or     for which no standard therapy is available.   "
59372|NCT02508428|"     The purpose of the study is to determine whether crosslinked Marathon and standard Enduron     polyethylene liners show differences in survivorship due to wear-related revisions at minimum     14-year follow-up and every 5 years after.   "
59385|NCT02508246|"     This phase I trial studies the side effects and the best dose of WEE1 inhibitor MK-1775 when     given together with docetaxel and cisplatin in treating patients with stage III-IVB squamous     cell carcinoma of the head and neck that may or may not be able to be removed by surgery     (borderline resectable). WEE1 inhibitor MK-1775 may block the growth of tumor cells by     blocking some of enzymes that are needed for tumor growth and may also help docetaxel and     cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in     chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Giving WEE1 inhibitor MK-1775 with docetaxel and cisplatin before surgery may     kill more tumor cells and shrink the tumor, allowing patients to undergo surgery to remove     it.   "
59386|NCT02508233|"     Many recent randomised multi-centre trials have used the AOS and the involvement of the     French-speaking population is limited by the absence of a French version. The goal of our     study was to develop a French version and validate the psychometric properties to assure     equivalence to the English original.   "
59387|NCT02508220|"     The study compares the short-term tinnitus reduction following a single oxytocin intervention     with a placebo control condition.   "
59373|NCT02508415|"     Obesity is an epidemic with increasing prevalence in the Asia Pacific region. The first     Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a     marked increase in obesity in 2003, 2004 and 2006 with 12.2%, 12.3% and 14.0% respectively.      Periodontal disease is a chronic inflammatory disease which results in gingival inflammation,     irreversible attachment loss, alveolar bone destruction and eventually tooth loss. Worldwide,     the prevalence of periodontitis in the adult population is about 10-15%. Periodontal disease,     through inflammation and destruction of the periodontium produces clinical signs and     symptoms, some of which may have a considerable impact on quality of life (QoL).      A positive association between obesity and periodontal disease was repeatedly demonstrated     worldwide. Obese individuals have elevated levels of circulating TNF- α and IL-6 compared to     normal weight individuals. These cytokines decrease after weight loss. Adipokines produced by     adipose tissue could be one of the mechanisms mediating the association between obesity and     periodontal disease. This suggests that obesity may have the potential to modify the host's     immunity and inflammatory system.      This project will extend the existing information on the association between obesity and     periodontal disease including QoL aspect to a Malaysia population. It will also improve     knowledge on the cellular and molecular mechanisms that underpin obesity-periodontal disease     relationship. By extension, this study also will cast light on the effects of periodontal     interventions for the subgroup population.   "
59374|NCT02508402|"     ABSTRACT:      Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish     whether dexamethasone plays a role in shorting the duration interval between initiation of     labor induction and beginning of the active phase in primigravida full-term pregnancy.      Methods: case control study included 86 primigravidae with full term pregnancy classified     into two groups: The participant of Group I will receive a prefilled syringe with two     milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not     receive Dexamethasone or any other cervical ripening agent.      Key Words: Dexamethasone;post-term pregnancy;induction of labor.   "
59375|NCT02508389|"     The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered     prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and     severity of radiation induced oral mucositis in patients who have been diagnosed with locally     advanced, non-metastatic squamous cell carcinoma of the head and neck.   "
59376|NCT02508376|"     This is a phase I randomized, double blind clinical trial designed to evaluate the safety,     tolerability and immunogenicity of the ID93 recombinant protein antigen alone or formulated     with GLA-SE or AP10-602 adjuvant in 70 healthy adults 18-49 years of age. Subjects will     receive a total of 3 doses administered intramuscularly on Days 1, 29 and 57. Subjects will     be monitored for approximately 422 days (365 days following the third study injection),     including safety laboratory analyses done just prior to and 7 days following each study     injection. Blood samples will be obtained for immunological assays (Luminex, intracellular     cytokine staining at Days 1 and 71, and antibody analysis at Days 1 and 85). The primary     objective is to evaluate the safety and tolerability of 10 µg ID93 + 5 or 10 µg AP10-602     compared to 10 µg ID93 + 5 µg GLA-SE and 10 µg ID93 alone following three consecutive     intramuscular injections administered on Days 1, 29 and 57.   "
59377|NCT02508363|"     The investigators are testing different ways of following up with drivers who attend our     health fairs to find the best way to make sure that taxi drivers go to important medical     appointments and have a regular doctor to help with their health problems.   "
59378|NCT02508350|"     The first objective of this study was to characterize the pharmacokinetics and     pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the     second objective is to identify the optimal dosing scheme for daptomycin among patients with     septic shock and to enhance therapeutic outcomes.   "
59379|NCT02508337|"     The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)     compared to vehicle in the treatment of subjects with inflammation and pain following     cataract surgery.   "
59560|NCT02505932|"     To date, use of arthroscopic procedure to perform Latarjet procedure is still technically     demanding. The benefits of arthroscopic procedure need to be evaluated compared to the     mini-invasive approach. The aim of this study was to assess postoperative pain during the     first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid.     At minimum 2 years follow-up, the recurrence of shoulder instability and functional     evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.   "
59380|NCT02508324|"     The purpose of this study is to determine the overall safety of adoptive immunotherapy when     given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of cells     from a donor to help fight cancer. The donor cells will be either from the umbilical cord     blood of a newborn baby or they will be cells collected from a relative (haplo-identical     cells).      The 2 cohorts that were discussed - adoptive immunotherapy with either UCB or haplo-identical     stem cells - will be analyzed separately.      Preliminary data from other centers has suggested that adoptive immunotherapy with cells from     a relative is an effective approach that may improve remission rates and survival in AML and     MDS, because they exert anti-cancer effects of their own (so called graft vs leukemia     effects) and possibly because they hasten recovery of cell counts from chemotherapy. The     Investigators are interested in confirming these data, but also in testing umbilical cord     blood cells for the same purpose. Preliminary data indicate that umbilical cord blood cells     may have more powerful graft vs leukemia effects and cause fewer side-effects.   "
59381|NCT02508311|"     Spinal cord injury (SCI), especially involving the cervical and upper thoracic segments, can     significantly compromise respiratory muscle function. Respiratory complications can ensue,     including lung collapse and pneumonia, which are the primary cause for mortality in     association with traumatic SCI both during the acute and chronic phases post-injury. Lesions     at the level of the cervical or high thoracic spinal cord result in respiratory muscle     weakness, which is associated with ineffective cough, mucus retention, and mucus plugging.     Despite the fact that pulmonary complications are a major cause of morbidity and mortality in     this population, there is a paucity of effective interventions in the SCI population known to     improve respiratory muscle strength with pharmacologic interventions receiving little to no     attention. The current objective of this study is to determine the effectiveness of 16 weeks     of sustained release oral Albuterol to; (1) improve respiratory muscular strength, and (2)     improve cough effectiveness.   "
59389|NCT02508194|"     This study will be the first assessment of the efficacy of MEDI7510 for the prevention of RSV     disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the     placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of     MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It     will also expand the safety database of subjects dosed with MEDI7510. The study will also     assess the immune response to MEDI7510 in Season 1 and Season 2.   "
59390|NCT02508181|"     The investigators enrolled pediatric patients who are undergoing strabismus surgery. The     investigators insert either an I-gel or laryngeal mask airway Supreme and measure the     intraocular pressures.   "
59391|NCT02508168|"     The purpose of this study is to determine the relative bioavailability of alogliptin 12.5     milligram (mg) and immediate-release metformin 1000 mg when administered as individual     tablets and as a fixed-dose combination (FDC) product.   "
59392|NCT02508155|"     The purpose of this study is to assess the safety, drug levels and effects on the body of     MEDI7352, in subjects with painful osteoarthritis of the knee.   "
59393|NCT02508142|"     This study aims to assess the analgesic efficacy and safety of intravenous 20 mg     Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with     acute gastroenteritis in the emergency department.   "
59394|NCT02508129|"     Insomnia and hypertension are common health problems that often occur together and influence     each other. This practical, low-cost, clinical trial will evaluate two behavioral treatments     for insomnia (a brief intervention with therapist contact and a self-guided Internet     intervention) compared to usual care. Participants will be recruited using the electronic     health record in their primary care physicians' offices, and will be evaluated for sleep,     blood pressure, and health outcomes after 9 weeks, 6 months, and 12 months.   "
59967|NCT02500641|"     Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36     weeks of treatment.   "
59398|NCT02508077|"     This phase II trial studies how well fluorouracil, leucovorin calcium, and irinotecan     hydrochloride (FOLFIRI) together with panitumumab work in treating patients with colorectal     cancer that expresses the RAS and B-Raf proto-oncogene, serine/threonine kinase (BRAF)     wild-type genes, has spread from the original site of growth to another part of the body     (metastatic), resists the effects of treatment with prior cetuximab (or panitumumab) plus     irinotecan hydrochloride-based therapy, and who have failed at least one subsequent     non-anti-epidermal growth factor receptor (EGFR) containing treatment regimen. Drugs used in     chemotherapy, such as fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving more than one drug     (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as     panitumumab, may block tumor growth in different ways by targeting certain cells. Giving     FOLFIRI together with panitumumab may be an effective treatment for colorectal cancer.   "
59399|NCT02508064|"     This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from     prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype     extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg     extended release tablet of BMS-663068.   "
59400|NCT02508051|"     Optimal patient care hinges on physicians remaining up to date with developing medical     knowledge. With ever increasing clinical demands however, the ability of physicians to do     this is compromised. While the structure of journal based reports requires the devotion of     significant time to glean emerging medical findings, social media can grab an individual's     attention and then direct them to external media sites, so as to obtain more specific and     detailed information of emerging medical findings. If medical journals were to fully embrace     social media, physicians would have a more time-cost effective means for staying up to date.      Specific aims Using the investigator's experience as editors of two medical education based     blogs, the Specific Aims of this project is to determine if a combined journal and social     media-based education strategy will be more likely to continuously engage physicians. The     investigators will specifically test whether physicians who access a medical journal blog     will have better knowledge of the information contained in a journal, measured by CME-based     questions of journal articles than they would if they only received links to the journal's     site.      Specifically, the investigators will randomize participants into 3 groups with all     interventions done by e-mail: group 1 is the usual care group, and will receive no     intervention except for a reminder every six months to take a test of journal-based     Continuing Medical Education (CME) questions from 2 anesthesiology journals; group 2 will get     e-mailed web links to different specific articles, including articles on which the CME     questions are based, published in 2 anesthesiology journals Monday through Friday with a     reminder to take the same test every six months; and group 3 will get e-mailed web links to     blogs Monday through Friday based on the same specific articles as in group 2; each daily     blog will focus on a specific article, including articles on which CME questions are based,     the blogs will have web links to the articles on which they are based and every six months     group 3 will get a reminder to take the same test. This will continue for 2 years' duration.     Every six months, the investigators will assess knowledge of material contained in the two     journals using CME material from the journals.      The investigators hypothesize that those participants randomized to group 3, the group that     will receive web links to blogs, will stay more informed, as measured by the test score of     CME-based questions. The investigators expect that both groups 1, usual care, and 2, e-mailed     links to articles, will have a similar low score as the investigators found in a preliminary     study of anesthesiologists who were presented with a set of journal-based CME questions.      Public Health Significance. This study will demonstrate the utility of journal based blogs as     a support to physicians in their effort to remain up to date with developing medical     knowledge.   "
59401|NCT02508038|"     This phase I trial studies the safety of transplantation with a haploidentical donor     peripheral blood stem cell graft depleted of TCRαβ+ cells and CD19+ cells in conjunction with     the immunomodulating drug, Zoledronate, given in the post-transplant period to treat     pediatric patients with relapsed or refractory hematologic malignancies or high risk solid     tumors.   "
59402|NCT02508025|"     Purposes of this research:        -  To study similarities and differences in FCE performances between participants from          different countries, jurisdictions, and evaluators.        -  To study determinants of FCE performance.   "
59419|NCT02507804|"     The aim of the study is to design and evaluate a PROMs diary for cancer patients to self     report side effects and experiences of their treatment, and thereby create a detailed account     of treatment related adverse events and their impact on daily activities to share with the     care team.   "
59420|NCT02507791|"     This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to     remotely track the physical activity of obese pediatric patients who are concurrently     enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit     devices and will be called weekly to review their average daily steps and heart rates.     Patients will receive the Fitbit either at the beginning of classes or upon completion of     classes. Patients will then be followed remotely and called weekly for 12 additional weeks     after completing classes. The two groups will be compared to examine for differences.   "
59421|NCT02507778|"     The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung     cancer.   "
59403|NCT02508012|"     Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors     have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD).     However, more than one-third of patients present primary resistance, and one more third     become resistant over time. One of the main factors associated with loss of response is the     immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the     TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the     serum and decrease its therapeutic activity. In this study the investigators propose a     medico-economic evaluation of the mesurement of anti-TNF agents and anti-drug antibodies     serum concentrations in the management of patients with inflammatory bowel disease treated     with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis     (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring.     In the monitored group, in case of loss of response, the clinician will use biological     informations to adapt the treatment following a simple treatment algorithm. In the     unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician.     Clinical and economical benefits of the biological monitoring will be evaluated after a     follow-up period of two years.   "
59404|NCT02507999|"     Goal directed therapy (GDT) is a technique, which employs a non-invasive cardiac output     monitoring (NICOM) device to guide management of circulating blood volume and blood pressure     during procedures. The purpose of this study is to determine whether the use of goal-directed     therapy to optimize blood volume and cardiac output during the procedure can improve the     outcome of patients undergoing endovascular treatment of a brain aneurysm.   "
59405|NCT02507986|"     The main objective of this study is to compare the incidence of detected atrial fibrillation     (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of     detected AF by a 7-Day Holter ECG.   "
59406|NCT02507973|"     The investigators will conduct an observational crossover study. The investigators aim to     recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial     pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley     Shock Trauma Center.      Overall, participants will be monitored, on average, for approximately 6-8 hours during the     study period. The investigators do not anticipate the need for prolonged monitoring during     the duration of their hospital stay or post hospital period.   "
59407|NCT02507960|"     In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma Pod™     system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in 15     fractions) course of whole breast radiation. The clinical target volume receiving 8 Gy will     be the surgical cavity as defined by the surgical clips and post-surgical changes + 5 mm. The     planning target volume (PTV) will add 5 mm to the clinical target volume to account for     geometric uncertainties.   "
59561|NCT02505919|"     A prospective multicenter randomized blinded study comparing Aquablation of the prostate with     the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The     primary endpoints for safety and effectiveness will be measured at 3 and 6 months,     respectively, and subjects will be followed out to 3 years to collect long-term clinical     data.   "
59409|NCT02507934|"     Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms     of discomfort, visual disturbance, and tear film instability with potential damage to the     ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation     of the ocular surface.      Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted     product of cells that line the joint tissues, which is present at the surface of articular     cartilage and it has been investigated on its roles at the ocular surface, in normal and     pathologic conditions such as dry eye.      The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye     drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution     in subjects with moderate dry eye.   "
59410|NCT02507921|"     The investigators aim to assess type and frequency of HIV drug resistance in adults     presenting to the Infectious Diseases Institute (IDI) in Kampala, Uganda, and compare this     data to patients from the Swiss HIV Cohort Study (SHCS). This study is a single-site,     cross-sectional study. The Investigators' goal is to perform viral load measurements in 2750     HIV-infected patients who have been on ART for 6 months or more. Presuming a detectable viral     load in 10%, resistance testing would then be performed in 250 patients on ART. All adult     patients attending will be screened for enrollment. Furthermore, the investigators' goal is     to perform resistance testing in 250 ART naive patients in order to detect transmitted     resistance mutations. Investigators will therefore consecutively screen and enroll 250 ART     naive patients who attend the clinic during the study period. For each participant, a case     report form (CRF) form will be completed which includes social, as well as medical     information. Investigators will ask each participant for permission to store plasma in case     resistance testing must be repeated, and serum, in case of future research questions.   "
59411|NCT02507908|"     The objective of this observational laboratory study is to measure the correlation between     5-hydroxyindolacetic acid (5-HIAA) in platelet rich plasma and 5-HIAA in 24-hours urine     collection in adult patients with a serotonin-producing neuro-endocrine tumor. Plasma and     urine of included patients are collected and 5-HIAA values are measured with LCMS-MS and     analysed.   "
59412|NCT02507895|"     Currently the process for stroke recovery is slow with majority of its treatments focused     around physical therapy. Among the many methods employed to facilitate recovery in stroke,     the use of motor imagery (MI) training may be beneficial towards stroke rehabilitation.      In the current study, we propose 2 aims. Our first aim is to determine the feasibility and     efficacy of a novel brain-computer interface-assisted MI train program (BCI-MI) in patients     with chronic ischemic stroke. This is designed as a proof-of-concept study that only require     a single-session trial. If patients successfully activate the BCI-MI system without much     difficulty, our second aim is to enroll patients into a 4-week training program using the     BCI-MI. Both functional magnetic resonance imaging (fMRI) and transcranial magnetic     stimulation (TMS) will be done to determine the effects of the 4-week training program.     Subjects may potentially see improvements in walking gait as preliminary data from previous     studies have demonstrated positive results.   "
62403|NCT02468804|"     We hypothesize that reductions in gamma activity are a key mechanism underlying cognitive     dysfunction in PD and that interventions to increase gamma activity will improve cognition.   "
59413|NCT02507882|"     Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide as well     as in Egypt. Despite improvements in HCC therapy, the prognosis for HCC patients remains     poor. Today molecular, genomic and epigenomic aberrations in tumors are being deeply     investigated. Many biomarkers were associated to HCC onset, and they could be useful for     clinicians, but all show some limitations and no one is so early to predict the HCC onset.      It is estimated that 51.5% of HCC cases can be attributed to HCV infection. Moreover, there     is a large occult reservoir of HCV caused chronic liver disease in approximately 9 % in the     Egyptian with estimated 6 million HCV chronic infections and estimated 150 000 new infections     per year. Among them, we have to mention the polymorphism of IL28B gene rs12979860 C/T. and     rs 4803217. The IL-28B gene encodes interferon-lambda 3 (IFN-λ3), which belongs to the type     III IFN family. IFN-λ interacts with a transmembrane receptor inducing a potent antiviral     response. In experimental model of HCV type III IFN was able to inhibit viral replication.     IL-28B polymorphisms are linked to the efficiency of the inflammatory process during HCV     infection, and to the mechanisms that HCV adopts to escape by innate and adaptive immunity.      During the last years, a number of studies have assessed the association between the IL-28B     polymorphisms and risk of HCC and liver cirrhosis (LC) occurrence in various populations;     however, results obtained are still inconclusive.      Interestingly, some polymorphisms located at the 3' untranslated region (UTR) of IL28B, e.g.     rs 4803217, seem to interfere with the binding of miRNA, to date recognized as important     post-transcriptional regulators. In the last years miRNAs acquired a growing relevance as     potential biomarkers for several diseases including cancer, and many researches are focusing     on understanding their role in cancer.      Thus the objectives of the current proposal are to determine through investigating a cohort     of 405 patients, whether IL28B rs12979860 and rs4803217 polymorphisms are associated to the     risk of HCC in chronic hepatitis C (CHC) patients and, above all, to identify their role as     predictor marker of HCC in CHC, when associated to miRNAs modulation. Data obtained by our     work could be helpful in HCC diagnosis, thus leading to the improvement of the patients     prognosis. The proposed activities are going to be implemented through a partnership us as     Egyptian Liver Research Institute and Hospital (ELRIAH)- Dakhlya- Egypt and Non- Egyptian     Partners.   "
59414|NCT02507869|"     Despite awareness of the benefits of engaging in regular physical activity, at least 50% of     adults in the US do not meet recommended guidelines for physical activity. One potential     explanation for this lack of regular physical activity is that people often experience     exercise as affectively unpleasant. Evidence suggests that the more positively people     experience exercise (i.e., the better they feel while exercising), the more likely they are     to engage in regular physical activity. This may be especially true for people in poor     cardiorespiratory condition. In this randomized trial, investigators compared the effects of     an affect-guided exercise prescription (intervention) to a heart rate-guided exercise     prescription (control) on change in physical activity minutes among previously underactive     adults. Investigators also tested whether the effect of the intervention was moderated by     differences in cardiorespiratory fitness.   "
59438|NCT02507557|"     Excessive fluid loss is often reported in gastrointestinal surgical patients due to     preoperative fasting and bowel preparations. Insufficient fluid infusion may cause     hypovolemia and tissue hypoperfusion, which may delayed postoperative recovery and even     induce postoperative acute renal failure. The aim of this study is to compare the effects of     Goal-directed fluid therapy (GDFT) strategy with that of the conventional fluid management on     the morbidity and mortality of postoperative complications, length of postoperative hospital     stay, and medical expense, so as to provide clinical evidences for optimized intraoperative     fluid management for patients undergone gastrointestinal surgery.   "
59439|NCT02507544|"     TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer     therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer     cell lines. The objectives of this study are to determine the safety profile of TRX-818     including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) and     determine the recommended dose and regimen(s) to initiate Phase 2.   "
59415|NCT02507856|"     The multi-center, prospective PRODAST study is investigating patients with non-valvular     atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack     (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. It consists of     a baseline visit and a 3 months central follow-up for patients who were discharged with     dabigatran, vitamin K-antagonists, antiplatelets only, or no oral antithrombotic treatment at     all. Thus, data on the use of dabigatran and vitamin K-antagonists in routine clinical     practice will be collected to describe how dabigatran is prescribed and used in the     population of AF patients with recent cerebrovascular events and how these factors influence     important outcome and safety events. The utilization of dabigatran will be assessed with     regards to treatment persistence, compliance, proportion of patients discontinuing treatment     and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or     systemic embolism. Due to the fact that patients will be treated according to local medical     practice it is possible that medication will be changed during the observation period. In the     follow-up, data from the first as well as from the second prescribed medication will be used     in the study. To explore a long-term effect of anticoagulation, survival up to one year will     be assessed.   "
59416|NCT02507843|"     This study evaluates vitamin D as an adjunctive treatment in patients with non-Cystic     Fibrosis bronchiectasis, which are combined with vitamin D deficiency. Half of participants     will receive vitamin D supplementation, while the other half will receive placebo.   "
59417|NCT02507830|"     Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran     2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The     investigators aim is to recruit 150 patients for the study.      The outcomes The investigators would like to determine are : postoperative pain,recurrences     and complication rates such as seromas.   "
59418|NCT02507817|"     During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory     factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF), neuregulin     1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated with     neurogenesis and differentiation of brain cells.      LIF is a cytokine that is essential for the development of the central nervous system, and     has recently been shown in rats that maternal LIF stimulates placental ACTH     (adrenocorticotropic hormone) that in turn promotes secretion of fetal LIF from nRBC     (nucleated red blood cell ), which in turn promotes brain development of the fetus In other     studies on rats a theory was proposed that LPS (lipopolysaccharide) and infection during     pregnancy influence the normal development of the brain and may cause brain damage by     altering placental ACTH thank in turn alters LIF secretion in the embryo which could be the     cause of brain damage.      Our hypothesis is that by treating the mother with Magnesium Sulphate we can protect the     embryo's brain in one of two ways:        1. Altering Placental ACTH        2. Altering the number of receptors for LIF in the brain Women who are at risk for preterm          labor prior to 32 weeks of gestation are treated with Magnesium Sulphate for          neuroprotection, randomized controlled studies showed that if these women are treated in          the 24 hours prior to labor with magnesium sulphate the risk for cerebral palsy and          other severe motor problems are decreased.      The mechanism for this decrease is unknown and that is the purpose of our study.      The purpose of our research is to examine maternal LIF levels prior to birth and Maternal and     cord levels after delivery and to see if levels are different if the mother was treated with     Magnesium Sulphate. We will also check the placental ACTH level   "
59422|NCT02507765|"     This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and     transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be     removed by surgery. SBRT is a specialized radiation therapy that delivers a high dose of     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal     tissue. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels     near the tumors and then blocking the blood flow to allow a higher concentration of the drug     to reach the tumor for a longer period of time. SBRT may make TACE more beneficial by     increasing blood flow to the tumor, which may allow more of the TACE chemotherapy to enter     the tumor. Giving SBRT with TACE may work better in treating patients with liver cancer that     cannot be removed by surgery.   "
59423|NCT02507752|"     This multicenter prospective observational study will evaluate the quality of life in     participants with rheumatoid arthritis (RA) who are initiated with rituximab     (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.   "
59424|NCT02507739|"     Mobilization, ambulation, during obstetrical work attitudes are naturally adopted by women     since ancient times in many countries. The advent of the epidural in the 60s revolutionized     the management of pain during childbirth. The consideration of such advance is to keep the     laboring parturients lying down. Indeed at this time the use of high doses of local     anesthetics charge of an engine block against formally allocate all up.      In a matchless analgesic efficacy during childbirth, epidurals also offers the possibility of     a secure obstetrical gesture because without general anesthesia, inhalation great purveyor in     these women with full stomach. These advantages explain the considerable growth in the number     of epidurals performed in obstetric work in France over the last thirty years. However, this     analgesia technique will soon be implicated in the alterations of obstetric mechanics, its     effects depend primarily on the nature and concentration of the products used.      Evolution is then marked by a considerable reduction of concentrations of local anesthetics     used with the addition of opioids, allowing to achieve an isolated analgesia without     impairing motor skills, it involves the lower limbs or muscles pelvis, allowing the woman to     mobilize.      Ambulatory epidural and made its appearance in the early 90. Responding to women in labor     demand wishing to receive effective labor analgesia without being confined to bed, she then     puts to the test the dogmas and practices on how to provide analgesia that is both effective     and safe. It is now well codified and used daily in some maternity hospitals.      The mobilization of women during labor is a subject that motivates obstetric teams Caen     University Hospital for many years. Motherhood has thus given the means for monitoring and     ambulatory epidural analgesia protocol suitable for this technique.      The introduction of this daily care protocol opens new possibilities of care delivery hoped     more physiological and less iatrogenic.      A critical evaluation of the changes possibly recorded on obstetric mechanics inherent     question, motivating, for which the answers are now few and discordant in the literature.      The investigators therefore propose a randomized study evaluating single-center relative to     obstetrical work typically occurring in a bed, the mobilizations of repercussions out of bed,     in terms of obstetrical mechanics and comfort of the parturient.      Those will be objectified by a significant change in the working hours. This study included     560 patients is scheduled to last 2 years. Positive effects could also have repercussions in     terms of public health and even of health economics.   "
59426|NCT02507713|"     Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease.     Nonspecific symptoms lead to a delay in the diagnosis, only confirmed by the     electrophysiologic study.      Objectives.        1. To establish the diagnostic value of ultrasonography in ALS.        2. To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients          with ALS.        3. To check the relationship between ultrasound, clinical variables and functional tests in          patients with ALS.      Methods. A longitudinal observational study in a consecutive sample of patients diagnosed     with ALS will be realized. All the patients will be examined 3 times during 6 months and     capabilities associated with ALS and muscle strength will be assessed. Bilateral and cross     sectional ultrasonography of several muscles and also median and tibial nerves will be     performed. All the images will be processed and analyzed for obtaining morphometric variables     (muscle thickness and nerve area) and textural ones (echogenic variation, entropy,     homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded.     After longitudinal study, a survival study will be performed in relation to functional and     sonographic variables.   "
59427|NCT02507700|"     Popliteal block is a technique for providing postoperative pain management in children. In     this randomized double-blinded study, the investigators evaluated the effects of preoperative     popliteal nerve block on postoperative pain and analgesic requirement in children with     cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale     and skin conductance fluctuations will be assessed.   "
59428|NCT02507687|"     This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost     SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or     ocular hypertension who are not adequately managed with topical IOP-lowering medication.   "
59429|NCT02507674|"     1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid          acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will          use a newly developed acquisition method and post-processing technique to create three          dimensional image models of the abdomen.        2. Study activities and population group. The study population will be a convenience sample          of patients 18 years and younger with suspected appendicitis, whose clinical care          (unrelated to the study) includes ultrasound and/or CT of the abdomen. The study          intervention includes acquisition of research ultrasound images, which will not be used          for clinical care, and comparison of these images with clinically obtained images. Other          clinical data such as surgical and pathology reports will also be reviewed. If not          evident from the patient medical record, the final diagnosis will be confirmed by a          telephone call to the subject 2 weeks after the initial visit.        3. Data analysis and risk/safety issues. This is a pilot study intended to determine          feasibility and to refine image reconstruction algorithms. Research images will be          compared to clinical images to determine the frequency of visualization of the appendix          and whether the appendix was deemed normal or abnormal. Comparison of research images          with final diagnosis will also occur. The research intervention, an ultrasound exam, has          no known safety risks. The only risk to subjects is loss of confidentiality.      This study is observational, not interventional, because the experimental ultrasound will be     performed in all subjects and will not be used in the clinical care of patients     (consequently, will not have the opportunity to affect clinical outcomes). Experimental     images will be reviewed after completion of clinical care and will not be provided to the     clinicians caring for the subjects. We are not measuring the effect of the ultrasound     examination on the subjects' outcomes.   "
59430|NCT02507661|"     The purpose of this study is to evaluate esthetic outcome of implant supported single crowns     after alveolar ridge preservation with beta three calcium phosphate with collagen type I in     aesthetic region in upper jaw.   "
59431|NCT02507648|"     Comparative randomized, single dose, two-way crossover open-label study to determine the     bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules (Pharmacare PLC, Palestine) and     Tamiflu® 75 mg capsules (Hoffmann-La Roche, Switzerland under license Gilead Sciences     ,California ,USA after a single oral dose administration of each to healthy adults under     fasting conditions.   "
59456|NCT02507310|"     Based on preliminary data and previous studies, we hypothesize that the ambient temperature     experienced by an individual influences his or her food intake. Specifically, exposure to     temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in     a sedentary situation. Researchers will execute a crossover randomized control trial     specifically testing thermal exposure and its effect on individual female's food consumption.   "
59432|NCT02507635|"     The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and     patients' quality of life and prevent the development of asthma. Therapeutic strategies also     target a reduction of pro-inflammatory mediators released from activated cells, including     mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may     increase the risk of asthma occurrence, especially in patients with persistent allergic     rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis,     regardless of symptom severity or persistence. They control all of the symptoms, but to a     lesser extent nasal congestion. New generation agents, such as levocetirizine and     desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.   "
59433|NCT02507622|"     The main goal of the study is demonstrate that e-Nose system function is not altered in     weightlessness and more specifically that gas concentration measurements are the same in     weightlessness and normal gravity.   "
59434|NCT02507609|"     The purpose of the study is to determine the relationship between the degree of neuromuscular     block, the release of cytokines and clinical outcomes in elderly patients undergoing     orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade decreases the     release of cytokine and the incidence of postoperative delirium in elderly patients     undergoing orthopedic surgery, compared with moderate neuromuscular blockade.   "
59435|NCT02507596|"     A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in     comparison with open flap debridement for management of periodontal intrabony defects.   "
59436|NCT02507583|"     This human Phase 1 trial is a continuation of a Phase 1 trial which enrolled patients with     recurrent gliomas (#TJU-14379-101) and which was designed after a previously conducted Phase     1 human trial at our institution. With certain modifications, it is intended to reproduce the     safety results of the recurrent glioma previous trials as well as explore any objective     clinical responses in newly diagnosed patients. Protocol 14379-101 is closed to accrual and     Abbreviated Clinical Report is prepared for FDA submission. The safety profile for this     protocol was quite favorable.      This treatment involves taking the patient's own tumor cells at surgery, treating them with     an investigational new drug (an antisense molecule) designed to shut down a targeted surface     receptor protein, and re-implanting the cells, now encapsulated in small diffusion chambers     the size of a nickel in the patient's abdomen within 24 hours after the surgery. Loss of the     surface receptor causes the tumor cells to die in a process called apoptosis. As the tumor     cells die, they release small particles called exosomes, each full of tumor antigens. The     investigators believe that these exosomes as well as the presence of the antisense molecule     work together to activate the immune system against the tumor as they slowly diffuse out of     the chamber. Immune cells are immediately available for activation outside of the chamber     because a wound was created to implant these tumor cells and a foreign body (the chamber) is     present in the wound. In this trial, a dose escalation of the therapeutic agent will involve     an increase in both biodiffusion chamber number as well as the time the biodiffusion chambers     remain implanted. The wound and the chamber fortify the initial immune response which     eventually leads to the activation of immune system T cells that attack and eliminate the     tumor. By training the immune system to recognize the tumor, the patient is also protected     through immune surveillance from later tumor growth should the tumor recur. Compared to     treatment alternatives for tumor recurrence, including a boost of further radiation and more     chemotherapy, this treatment represents potentially greater benefit with fewer risks.   "
83153|NCT02197585|"     To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.      Hypothesis: Glue may induce less complications and chronic pain than suture   "
59440|NCT02507518|"     Non small cell lung cancer is the first cause of cancer related death in France and is     becoming an increasing health problem in developing countries.      Recently for patient with no progression disease after first line chemotherapy, new therapies     were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib,     pemetrexed) with improved survival.      Until now, determination of efficiency of treatment is only based on morphological response     (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical     lesion modification.      Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a     biologically relevant tool for assessment of tumour response therapies.      The assumption of the study is that FDG PET would allow to earlier detect a lack of response,     thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained     up to evidence of progression disease.      However, despite the increasing use of FDG PET for predicting therapeutic response, there are     no validated criteria for judging response of maintenance therapy in non-small cell lung     cancer.      It seems necessary to determine standardized criteria response, earlier during the course of     maintenance therapy in patient with non small cell lung cancer.      The final aim is to optimize survival by an adapted metabolic imaging guided therapy.   "
59441|NCT02507505|"     The purpose of this study is to find out if two types of standard care anesthesia are the     same or if one is better for people who have hip fractures.   "
59442|NCT02507492|"     The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC)     injection of RM-493, in subjects with POMC (propiomelanocortin) or other related rare genetic     mutations, on body weight, metabolic function and blood pressure. Patients who respond during     the initial 84 days of treatment can enter into long-term (2-year) extensions. The study drug     (RM-493) will be administered in an unblinded fashion.   "
59443|NCT02507479|"     The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to     busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving     disease eradication in patients with lymphoid malignancies not eligible for standard     transplantation.   "
59444|NCT02507466|"     The overall objective of this subproject is to evaluate the individual and paired     contributions of intensity and variability of stepping training on lower extremity (LE)     function, health and community participation in patients with chronic hemiparesis     post-stroke.   "
59457|NCT02507297|"     The goal of this study is to understand the contribution of sleep-disordered breathing (SDB)     to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression.     The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on     sleep and depression symptoms in perinatal women. Participants will be pregnant women with     depression and sleep-disordered breathing. Participants will be randomly assigned to receive     either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and     sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly     thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at     baseline and again 8 weeks later.   "
59458|NCT02507284|"     This study evaluates the tolerability, safety and activity of SRX246 in the treatment of     irritability in patients with Huntington's disease. Two-thirds of all participants will     receive SRX246, while the other third will receive a placebo.   "
59445|NCT02507453|"     Parabolic flight is the only ground-based condition in which free-fall (0G) can be created     long enough for safely testing changes in human perception and behavior. In addition to the     0G period, parabolic flight generates equal duration periods of 1.8G, which present another     unique opportunity to test the same responses to hypergravity and back to 1G.      It is well known that performance decrements occur in astronauts during and after gravity     level transitions. Illusions are commonly felt in orbit as well disorientation and perceptual     limitations, mainly due to both psycho-physiological changes and adaptation and lack of     familiar points of reference in the space environment. Studies performed during previous     space missions showed several changes occurring in different gravity conditions, pointing     out, for example, that colors and shadows were misleading, the depth and distance perception     were weakened, and the linear perspective was lost. Visual perception is of primary     importance for spatial orientation and object recognition because the static vestibular     (otolithic) and proprioceptive signals are absent when free-floating. Consequently,     astronauts become increasingly dependent on vision to perceive motion and orientation. All     these factors play an important role in the adaptation of humans to spaceflight that needs to     be analyzed to understand the underlying mechanisms that regulate human psycho-physiological     adaptive process to changing gravity. Human psycho-physiological health has to be safeguarded     and possibly improved when long-term human space missions are programmed in the near future.      The primary objective of this experiment is to investigate if the SWI illusion is present in     altered gravity environments. Since weight cannot be estimated in 0G, investigators have     developed a procedure during which the subject is asked to estimate the objects' mass by     shaking them rather than lifting them. Our results in 1G indicate that a size-mass illusion     (SMI) is also present in 1G. Our hypothesis is that the previously observed alteration in 3D     visual perception in 0G, particularly in the height of 3D objects, as well as the change in     proprioceptive inputs, will be responsible for changes in the SMI in 0G and 1.8G compared to     1G. In a separate proposal, investigators will also propose to perform this experiment using     the ESA short-arm human centrifuge (SAHC), with subjects exposed to various centrifugal force     levels, to further investigate the role of proprioceptive cues in the size-mass illusion.   "
59446|NCT02507440|"     To find out if the administration of the local pharyngeal anesthetic, lidocaine, in     conjunction with Propofol during elective Esophagogastroduodenoscopy (EGD) is useful, safe     and impacts the time of discharge of patient compared to placebo.   "
59447|NCT02507427|"     To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during     robot assisted laparoscopic radical prostatectomy for preservation of erectile function.   "
59448|NCT02507414|"     It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common     event during upper gastrointestinal cancer surgery (UGC surgery) and that the induction of     the syndrome is an important factor in provoking further peri- and postoperative     complications and in worsening the surgical stress response (SSR). The characteristics of MTS     is hypotension, tachycardia, and flushing.      In order to uncover the role of MTS in cancer surgery and the effects on the oncological     patients, the aim of the project is:      1. To characterize MTS in patients undergoing three common forms of UGC surgery using a new     objective methodology and by recording biomarkers suspected of playing a role in the     pathophysiology of MTS and postoperative complication development.      Three different interventions will be examined during this prospective trial:        1. Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast          Imaging during surgery.        2. Analyses of plasma samples obtained pre-, intra-, and one day postoperatively.        3. Continuous measurements of haemodynamic variables during surgery.   "
59449|NCT02507401|"     The purpose of this study is to determine whether the mix of microbial species isolated from     biofilm-clogged voice prostheses is specific to each participant, whether the microbes are     orally-derived and whether the presence of specific species is a predictor of the frequency     with which patients discard devices due to malfunction. The microbes isolated from discarded     devices will be used to test the antimicrobial properties of newly-developed medical     silicones.   "
59450|NCT02507388|"     The purpose of this study is to assess the systemic pharmacokinetics (PK) of RTH258 in     subjects (Japanese and non-Japanese ethnicity) with neovascular Age-Related Macular     Degeneration (AMD).   "
59451|NCT02507375|"     This study will assess the safety and tolerability, and make a preliminary assessment of     activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or     metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior     chemotherapy regimen. The anticipated time on study treatment is until disease progression or     unacceptable toxicity, and the target sample size is less than 100 individuals.   "
59453|NCT02507349|"     Fifteen minutes is the typical length of an outpatient medication management appointment for     people with serious mental health conditions. These brief interactions with prescribers are     frequently provider-driven with insufficient time focused on the patient's needs and personal     recovery. Shared decision making is a strategy that could improve this interaction. This     study examines how technology can be used in the care process to amplify the voice of the     patient, support shared decisions, and improve treatment outcomes.      Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care on     two primary patient-centered outcomes: the patient experience of care with medication     treatment and the level of shared decision making. Investigators hypothesize that:        1. Person-Centered Care will result in greater improvement in patient experience of care          with medication treatment than Measurement-Based Care.        2. Person-Centered Care will result in a greater level of shared decision making during the          medication visit than Measurement-Based Care.      The study team will collect information from patients, caregivers, and clinic staff at     different points in time during the study. Patients will be asked to complete questionnaires,     and additional data on their service use will be gathered. Some patients and providers will     also be interviewed about their experiences with care. Investigators are especially     interested to learn if and how these two approaches are perceived to change medication     treatment, if patients are more satisfied and empowered in their care, and why and how     providers perceive and adopt changes to their clinical care.   "
59454|NCT02507336|"     The study seeks to provide long-term follow-up and/or to offer continued maintenance     thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be     followed until withdrawal of consent, or death.   "
59455|NCT02507323|"     This study has been designed as a randomized, double-blind trial to provide definitive     evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with     anterior ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary Percutaneous     Coronary Intervention (PCI). This study will also measure the effects of ticagrelor vs.     prasugrel on secondary endpoints listed above. This study design aims to test the hypothesis     that ticagrelor will reduce myocardial infarct size as a proportion of the ischemic area at     risk when compared to prasugrel.   "
62438|NCT02468349|"     The proposed research aims to compare Left ventricular remodeling outcomes among patients     with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided post-MI     treatment vs. non-telemedicine guided treatment.   "
59459|NCT02507271|"     The purpose of this project is to test the hypothesis that Speed of Information Processing     (SIP) deficits in acquired brain injury (ABI) can be remediated. The majority of individuals     with acquired brain injuries have speed of information processing deficits as part of the     cognitive sequelae of the brain injury. Empirical research is expected to demonstrate the     efficacy of computerized cognitive Speed of Information Processing (SIP) training in     individuals with ABI.      Study participants will be asked to attend two study visits over the course of approximately     13 weeks. Participants will be randomly assigned to either the experimental or control group.   "
59460|NCT02507258|"     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to     evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing     components marketed in the European Union (EU). These types of studies are required by     regulatory authorities for all THA and resurfacing devices that do not have medium to     long-term clinical evidence available at the time of gaining approval to market in the EU.     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2     rev 2.   "
59461|NCT02507245|"     The aim of this study is to assess the developmental patterns of lung function in children     affected by growth hormone deficiency after one year of GH therapy.The assessment by specific     questionnaires of quality of life and of parental stress index.Parameters will be evaluated     at the time of the diagnosis and after 12 months of GH therapy.   "
59462|NCT02507232|"     The purpose of this study is to test the effectiveness and safety of the NovoTTF-200A device     in patients with low-grade glioma when it's used by itself or used together with     temozolomide. Researchers would also like to know whether the use of NovoTTF-200A, with or     without temozolomide, is associated with fewer negative side effects on mental function that     may be seen with other currently used treatment options.   "
59485|NCT02506933|"     This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus     (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients     previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is     a virus that may reproduce and cause disease and even death in patients with lowered immune     systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces     of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened     virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the     ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV     complications and reduce the need for antiviral drugs in patients undergoing a donor     hematopoietic cell transplant.   "
59486|NCT02506920|"     The investigators wanted to study the postprandial lipemia after six oral fat tolerance test     with varying amounts of saturated fat in young healthy subjects.   "
59463|NCT02507219|"     The aim of this project is to determine whether the acute oral administration of Ibuprofen     changes the activation pattern in the amygdala and other brain structures during functional     magnetic resonance imaging. The investigators use a double-blind, randomized,     repeated-measures design. Each of the 20 healthy control subjects will be tested three times     and receive placebo, 200 mg or 600 mg dose of ibuprofen p.o. The study will consist of 4     sessions: a baseline screening session and 3 testing sessions scheduled 1-2 weeks apart. Each     of these individuals will undergo a multi-level assessment based on the RDoC approach that     consists of (a) a standardized diagnostic assessment, (b) self-report questionnaires     assessing the positive and negative valence domains as well as interoception, (c) behavioral     tasks assessing reward-related processing, avoidance, and aversive processing, cognition, and     interoception; (d) physiological measurements consisting of facial emotion expression     monitoring, heart rate and respiration, (e) functional magnetic resonance imaging focusing on     reward-related processing, fear conditioning and extinction, cognitive inhibition, and     interoceptive processing, and (f) biomarker assessments.   "
59464|NCT02507206|"     The purpose of the study is to examine the effects of the administration of a drug called     DAR-0100A on attention and memory in persons with schizotypal personality disorder (SPD).     DAR-0100A has not been FDA approved, however in recent studies has been used to treat     cognitive deficits, meaning problems in the way you organize your thinking, in people     diagnosed with schizophrenia.      Many people who carry a diagnosis of schizotypal personality disorder have trouble with     attention and memory. Increasing the presence of a brain chemical called dopamine has been     found to help people with schizophrenia with their attention and memory problems. This study     will investigate whether the same is true for people with schizotypal personality disorder by     using DAR-0100A, a drug that has been shown to help with the cognitive deficits of people     with Parkinson's disease by increasing dopamine effects. Information collected in this     experiment may lead to a better understanding of the brain mechanisms involved in schizotypal     personality disorder and improve treatments for the psychological problems associated with     this condition.   "
59465|NCT02507193|"     The primary objective of this study will be to evaluate the functional outcome of patients     who present with a distal fibula fracture who were treated with either intermedullary nail     (IMN) fixation or plate fixation.   "
59466|NCT02507180|"     This is prospective cohort study, in pregnant women who present with signs and symptoms of     possible deep vein thrombosis. All patients will have the same method of assessment of their     DVT symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done)     to determine if a compression ultrasound is required. All patients will be followed for a     period of 3 months.   "
59467|NCT02507167|"     The purpose of this study is to evaluate the impact of genetic variants of OATP 1B3 or MRP 2     on the systemic disposition of endogenously formed CCK-8 and to determine the influence of a     single-dose of the transporter inhibitor rifampin (600 mg) on the systemic disposition of     endogenously formed CCK-8. Endogenous CCK-8 secretion will be induced by a single-dose     standardized liquid mixed meal.   "
59468|NCT02507154|"     This study aims to determine the safety and efficacy of expanded activated autologous NK     cells administered after cetuximab in patients with EGFR-positive nasopharyngeal carcinoma or     head and neck squamous cell carcinoma.   "
59720|NCT02503852|"     The primary objective of this study is to evaluate the safety and feasibility of the Celution     and Puregraft Systems in the processing and preparation of an autologous fat graft enriched     with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia     androgenetica.   "
59469|NCT02507141|"     The purpose of this study is to get images (pictures) of oral lesions, which occur inside the     mouth, before the patient's surgery using a special camera. These pictures will be used in     our research to evaluate a new technology that uses a laser and takes pictures of the     microscopic structure of tissue. The technology is called reflectance confocal microscopy.     We would like to compare what the camera sees to biopsies (pathology) of the same area. We     will evaluate the pictures obtained from the patient to determine whether this technology may     be useful in the future. We hope this technology can be used as a tool for early diagnosis of     oral cancers and for guiding surgery.   "
59470|NCT02507128|"     The investigators planned to evaluate the effects of liraglutide on no-reflow in patients     with acute ST-segment elevation myocardial infarction (STEMI).   "
59471|NCT02507115|"     This project will develop an intervention delivered through text messaging to reduce alcohol     consumption and high risk drinking among adults who are enrolled as students in community     colleges.   "
59472|NCT02507102|"     This feasibility study will assess the effects of the Nativis Voyager therapy in patients     with recurrent GBM who have either failed standard of care or are intolerant to therapy. The     study will enroll and treat up to eleven subjects over six months. Safety and clinical     utility will be evaluated.   "
59473|NCT02507089|"     This study aims to develop educational tools and platforms to promote the transfer of sleep     health information to blacks to foster adoption of healthful sleep practices.   "
59474|NCT02507076|"     This pilot clinical trial studies isolated limb perfusion with melphalan in treating patients     with stage IIIB-IV melanoma or sarcoma. Drugs used in chemotherapy, such as melphalan, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Heating a chemotherapy solution and infusing it directly into     the arteries around the tumor may kill more tumor cells.   "
59499|NCT02506738|"     The aim of the study was to demonstrate the effectiveness of telemonitoring functional status     and vital signs to early detect heart failure exacerbation, and to minimize readmissions and     length of hospitalisations.      Patients over 75 with heart failure were included after a hospitalisation due to heart     failure exacerbation. Patients were assigned randomly into intervention or control. The     intervention group comprised 47 patients who were assessed through telemonitoring, while 40     followed traditional clinical pathways.      Patients were followed-up for 3 months after discharge, collecting emergency visits and     readmissions due to a new heart failure exacerbation. Those patients in the intervention     group used a commercial telemedicine system: Careline H@me, which was provided by the company     SALUDNOVA. They system was personalized by adding the functional status monitoring     capabilities. Thus, the system collected vital signs (i.e. blood pressure, heart rate,     respiratory rate, oxygen saturation, glucose, and weight); symptoms of decompensated heart     failure (i.e. dyspnoea and orthopnoea); and functional status (i.e. part of the Short     Physical Performance Battery, SPPB) and a brief questionnaire (i.e. Do you have the     medication?) every 48 hours.      Two staff geriatricians at the Hospital Universitario de Getafe accessed, during working     days, a secured dedicated web-portal to assess the progression of their patients, evaluated     through the monitored variables and the self reported symptoms. They reacted to the data, if     needed, making a phone call or visiting the patient. Besides, patients could contact the     geriatricians or attending the emergency room as usually.      After completion, we analysed the results. First, we carried out a descriptive analysis of     the data. Later, we analysed the effects of the intervention with telemedicine and the     predictive values of the different measured variables through logistic regressions.   "
59475|NCT02507063|"     The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised     ICP has many potential benefits. This includes having assessments that can be made at the     bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise     in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove     useful in the emergency department (ED) setting in the evaluation of shunts used for     cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate     with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The     investigators further hypothesize that ONSD changes will correlate with changes in ICP,     making it a useful bedside tool for assessing ICP changes over time. This is a prospective,     observational study using a convenience sample. Children who are 0 - 18 years old who have an     invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care     Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who     are determined to require a shunt revision following evaluation in the ED will also be     included in the study. 10. After the invasive intracranial pressure monitoring device is     placed, for every recruited patient, ONSD measurements will be taken and the ICP will be     recorded 8 hours post placement and then repeated 3 times a day until the intracranial     pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision     patients, the investigators will obtain a measurement just before surgery, immediately     post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready     for discharge prior to 36 hours, the measurement may be omitted or done early so as to not     unnecessarily prolong the hospitalization   "
59476|NCT02507050|"     The aim of the study is to test whether, in patients with angina and flow limiting epicardial     coronary artery disease, pre-treatment with Ivabradine, as opposed to beta blockers, will     reduce post percutaneous coronary intervention induced microvascular dysfunction.   "
59477|NCT02507037|"     In this randomized controlled study, consecutive outpatients scheduled for elective     colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before     colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum     plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston     Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of     procedure, patients' tolerance, and adverse events were also evaluated.   "
59478|NCT02507024|"     The aim of this project is to develop a disease specific patient reported outcome measure     (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a     questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV).     Patients with AAV have inflammation in the small blood vessels leading to involvement of a     range of organs and can suffer from ongoing disease activity or treatment side effects.     Quality of life can be measured by patient reported outcome measures (PROMs).   "
59479|NCT02507011|"     The investigators will conduct a, randomized, phase 2, placebo-controlled, double-blinded,     crossover trial of carvedilol in 26 PAH patients with World Health Organization functional     class II or III symptoms and RV ejection fraction (EF) < 45% for 6 months.   "
59480|NCT02506998|"     The purpose of this study is to determine the changes of quality of life of patients with     allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte     Extracts (DLE). All patients will receive DLE in combination with current guide     lines-suggested standard medication.   "
59481|NCT02506985|"     The trial is an open-label, randomized, trial examining novel biomarkers of thrombosis in     patients managed with rivaroxaban vs. standard care following treatment of pulmonary embolism     (PE) with catheter-guided alteplase. Patients >18 years old who present with PE and are     managed with catheter-guided alteplase will be screened for study inclusion. Patient's     meeting inclusion/exclusion criteria will undergo informed consent. Immediately following     completion of alteplase infusion, patients will be randomized to receipt of rivaroxaban 15 mg     oral bid for 21 days followed by 20mg oral daily or continuation on unfractioned heparin or     low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3. Blood     samples will be taken within 2 hours of CDT completion prior to receipt of study treatment     (study day 1), at 8h-12h, 24h, 48h, 5d (or prior to hospital discharge), and at 30 day     follow-up. Clinical endpoints, including bleeding, evidence of thrombosis progression, and     death will be tracked during index hospitalization and at follow-up 30 days post-discharge.   "
59482|NCT02506972|"     The purpose of this study was to determine the impact of serving size and the addition of     sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice     cereal.   "
59483|NCT02506959|"     The goal of this clinical research study is to learn if a combination of panobinostat,     gemcitabine, busulfan, and melphalan and a stem cell transplant can help to control MM. The     safety of this combination will also be studied.   "
59484|NCT02506946|"     This project focuses on an at-risk adolescent and young adult population who may gain     long-term health benefits from detection of risk factors at a young age. The primary aims of     this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary     Syndrome (PCOS) are more likely to have elevated liver fat (>/=4.8%) than controls by     studying liver fat deposition measured by magnetic resonance spectroscopy (MRS); 2) To assess     the association of percentage liver fat with biomarkers of Non-alcoholic fatty liver disease     (NAFLD), dyslipidemia, insulin resistance and body composition in PCOS and controls.      In the proposed study, 40 adolescents and young adults with PCOS and 40 age-comparable     control subjects will be evaluated for metabolic disturbances and elevated liver fat using     noninvasive and state-of-the-art techniques including MRI, dual-energy x-ray absorptiometry     and an oral glucose tolerance test in order to fully assess the metabolic and body     composition differences between these groups. This research proposal represents a critical     step in understanding the metabolic and cardiovascular comorbidities of PCOS and their     relationship to NAFLD. The investigator hopes to use the results generated by this research     proposal in order to lay the groundwork for the prevention and treatment of metabolic     disorders in adolescents with PCOS. The overarching goal is to decrease and prevent lifelong     morbidity associated with this common disorder.   "
59573|NCT02505763|"     The main objective of the study is to assess the cost-effectiveness ratio of two management     strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a     strategy without thoracic ultrasound.   "
59487|NCT02506907|"     The overall aim of this work is to assess the relationship between stroke risk and     hemodynamic compensation strategies, as measured using a novel 3.0 Tesla MRI protocol, in     patients with symptomatic intracranial (IC) steno-occlusive disease. Recent studies have     shown high two-year ischemic stroke rates in symptomatic patients with IC arterial stenosis.     Therapy for IC stenosis patients includes revascularization with angioplasty, IC stenting, or     bypass, however identification of patients most likely to benefit from these more aggressive     interventions, rather than medical management alone, has been problematic. Accurate     measurements of hemodynamic compromise are likely required to better define stroke risk and     guide treatment decisions. Specifically, in IC stenosis patients with compromised cerebral     perfusion pressure (CPP), the extent of hemodynamic compromise reflects the autoregulatory     capacity of vasculature to increase arterial cerebral blood volume (aCBV) and/or develop     collaterals to supplement cerebral blood flow (CBF). The prevalence of CBF collateralization     and aCBV autoregulation has been hypothesized to correlate uniquely with stroke risk, however     the extent of this correlation has been debated. The critical barrier to stratifying stroke     risk rests with a lack of (i) methodology for measuring multiple hemodynamic factors with     high specificity and (ii) noninvasive approaches capable of monitoring longitudinal     progression of impairment. The investigators have demonstrated the clinical utility of     relatively new, noninvasive MRI approaches for assessing cerebrovascular reactivity (CVR),     aCBV, and collateral CBF. The investigators hypothesize that stroke risk can be more     completely evinced from collective measurements of these parameters. Therefore, the     investigators propose to implement a novel, validated hemodynamic MRI protocol to assess     tissue-level impairment and compensation strategies in patients with IC stenosis. Using a     collective approach combining measurements of collateral CBF, aCBV and CVR in multiple brain     regions, in conjunction with a statistical model incorporating the above variables as     possible prognostic factors, the investigators will quantify the extent to which two-year     stroke risk is associated with hemodynamic compensation mechanisms. The noninvasive and     multi-faceted scope of this investigation is intended to expand the diagnostic stroke     infrastructure and elucidate new hemodynamic prognostic indicators of stroke in this     high-risk population.   "
59488|NCT02506894|"     Two groups of women with preterm labor will be included. One will receive magnesium sulfate     for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler     indices will be measured before and after intake of either magnesium sulfate or placebo to     find if any significant changes occur in fetal cerebral blood flow.   "
59489|NCT02506881|"     This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and     safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen     Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate     the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single     subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a     dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval     of at least 25 days.   "
59490|NCT02506868|"     The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and     Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.   "
59491|NCT02506855|"     This study attempts to learn about the effectiveness of a modification to the Transversus     Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the     abdominal wall postoperatively using ultrasound guidance. The investigators want to see if     regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread     in the appropriate plane could reduce error and improve postoperative recovery.   "
59492|NCT02506842|"     The purpose of this study is to investigate the activity and safety of second-line adjuvant     therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and     fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.   "
59538|NCT02506218|"     This study will be conducted using standardized techniques to collect blood samples via an     acute, randomized, cross-over design. Subjects will be provided all of their meals the day     prior to testing and participate in 3 testing days with a minimum of 1 week break between     testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a     catheter and collect blood samples from an antecubital vein using sterile techniques.   "
59493|NCT02506829|"     The investigators plan to compare the impact of two approaches for smoking cessation on     smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse     population of patients at the Manhattan campus of the VA New York Harbor Healthcare System,     which serves a critical safety-net role for urban veterans. During hospitalization, all     smokers will receive usual care. Patients will be randomized to one of two arms: financial     incentives plus usual care vs. usual care alone, which includes referral to the state     Quitline. All patients enrolled in the study will be offered nicotine replacement therapy.     The investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12     months after discharge. The primary study outcome is smoking abstinence at 6-month follow-up,     verified by salivary/urinary cotinine.   "
59494|NCT02506816|"     The primary objective of this study is to identify, in human tumour samples, biomarker     changes associated to short exposure to AZD2281 as potential predictors of activity in     Endometrial Carcinoma (EC).      This is an exploratory study with a biological primary endpoint. Clinical efficacy or safety     are not a primary objective of the study.   "
59495|NCT02506803|"     Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international     oncology meeting and represents a new standard regimen in the treatment of metastatic     pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy     as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only     two cycles (three times weekly and one week rest) of GEMABR regimen.   "
59496|NCT02506790|"     This study evaluates the addition melatonin and metformin to toremifene in the treatment of     locally advanced breast cancer. Third of patients will receive toremifene, other third will     receive combination of melatonin and toremifene and other patients will receive combination     of metformin and toremifene.   "
59497|NCT02506777|"     This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC     (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast     cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of     melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6     cycles.   "
59498|NCT02506751|"     This study will evaluate the safety and tolerability of synthetic T3, liothyronine. It will     establish if there are changes in MS symptoms and if there is a positive effect on markers of     neuronal health.   "
59500|NCT02506725|"     The goal of Quarenta Semanas is to remove risk factors for preterm birth by linking women to     prenatal care in the first trimester; supporting, educating and empowering women in pregnancy     to reduce maternal stress and interrupt social, psychological, attitudinal and biological     risk factors for preterm birth; and providing evidence-based, quality care that identifies     and intervenes medically to treat underlying chronic and emergent conditions associated with     preterm birth.   "
59501|NCT02506712|"     The main objective is to quantify energy expenditure when using the SmartDrive system during     manual wheelchair propulsion in external conditions (slope, straight line). For this two     comparisons are performed:      Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute     propulsion test.      Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion     test.   "
59502|NCT02506699|"     For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has     found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by     some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted     through a neurosurgical procedure. This is common practice at the University Hospital of Caen     and in different CHU with the proper equipment rTMS. It seems permissible to provide in our     center only a non-invasive technique for patients challenged with brain surgery, since     according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated     to the repetition of sessions.      Assessment centers and the treatment of pain allow a multidimensional assessment,     bio-psycho-social of patients in order to optimize their management and experience     efficiently analgesics first- and second-line.      We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation     parameters reproduced according to a literature review, during 3 months after 5 active     sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory     to treatment of first and second line, followed by multidisciplinary center specializing in     chronic pain Lower Normandy. The quality of life will also be assessed by validated scales,     and the results will be compared to the literature data.   "
59503|NCT02506686|"     A prospective, open-label study investigated the pharmacokinetic profile of meropenem in     patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB     penetration into cerebrospinal fluid (CSF).   "
59504|NCT02506673|"     Little is known about perioperative stress responses and possible anxiety mitigating factors     like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective     questionnaires, and are not based on real-time gathered data. Skin conductance measurements     allow the sympathetic discharge to be evaluated down to fractions of a second and enable us     to continuously monitor stress responses as skin conductance responses/per second during the     perioperative management. In our study, the investigators propose to examine the effect of     personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and     overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia.     Patients will be randomly assigned to either receive traditional sedation or light sedation     in addition to audiovisual equipment. The investigators hope to determine outcome estimates     of the use of this equipment on stress levels using skin conductance measurements, request     for further sedation, postoperative pain levels and analgesic consumption, time to discharge     readiness, and overall patient satisfaction, and collect thus far unavailable data on the     stress response to perioperative stresses (such as IV insertion and spinal placement) in     order to allow for power analyses for future studies.   "
59552|NCT02506036|"     This study is being done to test the feasibility and effectiveness of web-based     social-cognitive training exercises in treating social-emotional deficits in patients with     stroke or frontotemporal dementia (FTD).   "
59553|NCT02506023|"     The purpose of this study is to determine how female hemophilia A carriers respond to a     medication called DDAVP (Desmopressin).   "
59505|NCT02506660|"     Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain     after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a     corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The     addition of higher doses of dexamethasone to nerve blocks, which are injections of local     anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce     pain. However, it is unclear whether the advantage of longer pain relief outweighs patient     dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have     shown that systemic, intravenously administered dexamethasone may similarly reduce pain     levels when compared with dexamethasone in the block. In our study, the investigators propose     to examine the effect of low-dose IV versus block dexamethasone on interscalene block     duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more.     One study suggests that 1 mg may have the same effect as larger doses. Our aims are to     determine whether the addition of low-dose dexamethasone to a local anesthetic in the block     can prolong its duration, and whether there are differences in postoperative pain,     consumption of painkillers, side effects, and satisfaction in patients who received IV or     block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or     block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block     duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and     7-10 days after surgery. Results from this study will reveal whether patients prefer the     longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.   "
59506|NCT02506647|"     This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over,     pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan &     Lee's insulin glargine injection in comparison to the marketed Lantus (US) in subjects with     type 1 diabetes mellitus (T1DM).   "
59507|NCT02506634|"     Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with     upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy     or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux     was defined as the percentage total time for which a pH value < 4 was >4.2 % in the distal     esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The     symptom scores were measured by the frequency score multiplied by the severity scores of the     predominant symptom before and at the end of the treatment, and the  PPI test  was defined     as positive if the overall scores of the predominant dyspeptic symptom in the fourth week     decreased by >50 % compared with those of the baseline.      GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump     inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in     the symptom questionnaire in Chinese outpatients in Gastroenterology department will be     calculated. The symptom of the highest percentage will be the primary symptom.   "
59508|NCT02506621|"     Randomised crossover study comparing the sensitivity and specificity of 5 External loop     recorders in detecting pacemaker detected Atrial fibrillation burden.   "
59509|NCT02506608|"     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously     difficult to treat. Amputation usually follows traumatic injuries or surgery following     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is     required for the survival of the patient. The loss of a limb or other body parts is usually     followed by the sensation that the lost body part is still present and can be felt. These     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure     on the residual limb) and psychological factors (e.g. emotional stress). It is well known     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,     psychological and other, are ineffective. Today it is believed that phantom limb pain may be     related to changes in the cortex of the brain. There is evidence that these changes may be     modulated - or even reversed - by providing sensory input to the stump or amputation zone.     For example, cortical reorganization and alleviation of phantom limb pain has been observed     in amputees following intense use of a hand prosthesis. However, there is no consistent     knowledge on which type of peripheral sensory feedback may be effective in affecting the     cortical plasticity or on how to best apply the sensory feedback. The aim of the proposed     research is to create natural, meaningful sensations through providing non-invasive sensory     feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom     limb pain and restore the cortical neuroplastic changes.   "
59510|NCT02506595|"     The purpose of this study is to obtain preliminary data of the efficacy of Exposure,     Relaxation, and Rescripting Therapy for nightmares among active duty military personnel.   "
59511|NCT02506582|"     The purpose of this randomized, double-blind, placebo-controlled study was to determine     whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control     of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.   "
59512|NCT02506569|"     The investigation is designed to provide supporting evidence for the clinical safety of the     Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3     Tesla MR conditions .   "
59513|NCT02506556|"     This is a phase II, exploratory, open-label, single arm study of BYL719 monotherapy, a     selective phosphatidylinositol 3-kinase (PI3K) alpha inhibitor, in adult patients with     advanced metastatic breast cancer progressing after first line therapy. Patients with     advanced hormone receptor positive tumors will be required to have an alteration of the PI3K     pathway. Those patients with advanced triple negative breast cancers are genetically     unselected for this study.   "
59525|NCT02506387|"     The primary objective of the registry is to investigate and follow all patients treated with     the MitraClip System in Belgium. This information is intended to contribute to decision     making with regards to MitraClip therapy selection in patients with mitral regurgitation: (a)     by establishing the clinical value of the MitraClip therapy in the continuum of care; and (b)     by providing practical information that will allow physicians to make therapeutic decisions,     assist hospitals to make purchasing decisions, and assist insurers/government in making     coverage decisions.      In addition national data will be shared with European registries in order to increase the     knowledge about the efficacy of this new technique.   "
59526|NCT02506374|"     This non-intervention qualitative study will use focus groups to assess the feasibility and     acceptability of a proposed intervention for a future study. The focus group will discuss a     potential biobehavioral family self-management intervention designed to improve sleep in     persons with Alzheimer's disease (PAD) and their caregivers (CG).   "
59600|NCT02505412|"     Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac     screening needed?   "
59514|NCT02506543|"     The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls     in three refugee camps in Ethiopia. The study design will employ a two group wait-list     cluster randomized controlled trial where girls will be invited to participate in the COMPASS     program, assigned to groups of approximately 20 for the purposes of the program, complete a     pre-test baseline assessment, and will then be randomized by group to the intervention or     control condition. In addition, qualitative research will address additional questions of     acceptability, processes of change and best practice.      Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to     determine whether the participants receive the intervention or are placed on the wait-list     immediately following the baseline. Those that do not get the curriculum during the study     will receive it following the endline phase of the study so as to not create tensions or     jealousies.      The intervention, the COMPASS program, will involve a structured intervention for girls     between the ages of 13-19 that is intended to engage adolescent girls, those who are     influential in their lives, service providers and other stakeholders, with the ultimate goal     of co-creating environments in which girls are valued and safe. The program is centered on     establishing or supporting community-supported safe spaces for girls where they can come and     gather among themselves and participate in a structured life-skills curriculum.   "
59515|NCT02506530|"     This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive     treatment in reducing secondary lymphoedema in breast cancer.   "
59516|NCT02506517|"     This is a phase 2 study (the second phase in testing a new drug) to see how useful an     investigational drug called afatinib is in patients with advanced cancer with changes in the     HER gene.      Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung     cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein     called HER from working. HER is an important protein that contributes to the growth of cancer     cells.   "
59517|NCT02506504|"     In patients with severe Chronic Obstructive Pulmonary Disease (COPD), exercise tolerance is     severely impaired due to a ventilatory limitation, levelling off the intensity of exercise.     This reduces the physiological benefit of pulmonary rehabilitation. In these patients, it is     then proposed to add an Inspiratory Pressure Support (IPS) in order to increase the intensity     and the duration of every training session. In a preliminary study, the investigators showed     that IPS applied during an exhaustive cycling exercise allowed to prevent the onset of     post-exercise quadriceps fatigue evaluated by the endurance time to isotonic quadriceps     contractions (TlimQ).      The aim of this study is to determine the relationship between the prevention of     post-exercise fatigue (TlimQ) and the change in training load (intensity x time x number of     sessions) during a pulmonary rehabilitation programme. At the beginning of the training     programme, 25 patients will be evaluated for TlimQ after a cycling exercise (70% maximal     workload) with and without IPS in random order. The training load was then monitored at every     exercise session of the programme.   "
59518|NCT02506491|"     This study is based on assess and contrast isometric and isokinetic core strength, static and     dynamic balance, the number of falls, and functional autonomy in three different old women     groups after a 22 weeks 1) Pilates-based structured exercise program, 2) muscular structured     exercise program, and 3) nonexercising.   "
59519|NCT02506478|"     ED patients who are able to drink juice will be approached and asked their beverage     preference.   "
59520|NCT02506465|"     The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as     compared to control group (catheter only).   "
59521|NCT02506452|"     The purpose of this study is to compare the wound closure outcomes of subjects receiving     diabetic foot ulcer treatment with and without the use of Biovance®.   "
59522|NCT02506439|"     Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant     women.   "
60049|NCT02499575|"     Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In     this study the investigators plan to determine the ability of Exparel to control     post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion     surgery, 1st MTP fusion, and cheilectomy).   "
59523|NCT02506426|"     Chronic sinusitis is a disease involving severe swelling of your facial sinuses and nasal     cavity. Chronic sinusitis is a common disorder and roughly 5% of adult men and women have     chronic sinusitis in Canada. Surgery has shown to have benefits for people suffering from     chronic sinusitis. There are two surgeries which have been shown to help people: 1)     Endoscopic sinus surgery with septoplasty and 2) Septoplasty alone. Both surgeries have     research which show they help improve quality of life and reduce symptoms. However, it is     unknown which surgery is better.      'Endoscopic sinus surgery with Septoplasty' uses special telescopes through the nostrils to     make the nasal septum straight and open the facial sinuses without any incisions. The sinuses     are opened using special microscopic instruments and the procedure takes approximately 90-120     minutes.      'Septoplasty alone' is a shorter (take approximately 25-30 minutes) and less invasive (do not     open the facial sinuses) that might provide the same benefits compared to the larger and     longer endoscopic sinus surgery.      Currently, performing 'Endoscopic Sinus Surgery and Septoplasty' together is the standard of     care, however, there is limited evidence to support just performing 'Septoplasty alone'     provides similar results but it is shorter and has lower risks. This represents a significant     gap in the investigators' knowledge, which adversely impacts a doctor's ability to counsel     patients who have chronic sinusitis and elect to undergo surgery.      The purpose of this study is to understand which surgery (endoscopic sinus surgery plus     septoplasty OR septoplasty alone) is the most appropriate for people with chronic sinusitis.     You are being asked to participate in this study because you have chronic sinusitis and are     also going to have surgery to improve your quality of life.   "
59524|NCT02506413|"     This study aims to adapt and implement a district-led, policy-based, low cost Maternal and     Newborn Health (MNH) intervention package using the MamaToto process, proven successful in     Uganda, in rural Tanzania. The investigators hypothesize that the 'MamaToto Package' will be     successfully implemented in the Misungwi District and will be effective in improving key     maternal and newborn health indicators of study participants.   "
59759|NCT02503345|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of different     doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary     hyperoxaluria and recurrent kidney stones.   "
59527|NCT02506361|"     This is a prospective、multicenter、non-comparative interventional case series. 800 breast     cancer patients who have already received chemotherapy prior to this study will be enrolled     in the group, including 400 patients received the anthracyclines followed taxanes     chemotherapy, and the other 400 patients who have received regiments containing no taxanes.     Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay.     Meanwhile, 10 years followed-up survey will be conducted. The relationship of TOP2α     expression and 5- year or 10-year disease free survival(DFS) and overall survival（OS）will be     identified in this study.   "
59528|NCT02506348|"     In this study we test Diclofenac and Nepafenac and compared patients experience and comfort     following administration of these ophthalmic drops.   "
59529|NCT02506335|"     Background: It is still difficult to predict the outcome in patients requiring Fontan     Revisions and in those who have evidence of congestive hepatopathy and probable cirrhosis     requiring major cardiac surgery including heart transplant. Over the years, many prognostic     indices have been derived from laboratory results of blood tests, clinical and physiological     variables (or some combination thereof), from liver imaging to liver histology, which has     issues of sampling error, medical risks and technical difficulty. None of these have proved     entirely satisfactory. Predicting morbidity or survival is particularly important when     deciding about Fontan revisions versus the need for heart transplantation. What is needed     here is a truly reliable test of liver function that can help predict outcome, on the basis     of a single measurement within few days of a planned revision. For this purpose, it is     desirable that the chosen tests of liver performance be safe, non-invasive, easy to perform,     have a rapid turnaround for results, and be readily repeatable.      Tests of hepatic elimination of various exogenous substances have been described, such as     galactose elimination capacity (GEC), indocyanine green (ICG) clearance, lidocaine metabolism     to monoethylglycinexylidide (MEGX), and other tests that rely on liver metabolic capacity.     None of these metabolic or clearance tests achieved widespread acceptance or use, mostly     because their performance and analyses were cumbersome.      HepQuant,LLC has developed a platform of tests of liver function which include Systemic     Hepatic Filtration Rate (HFR), Portal HFR, SHUNT, and Disease Severity Index (DSI)1,2.     HepQuant tests specifically target the hepatic uptake of cholate and use a single noninvasive     test of 90 minutes duration to quantify the systemic circulation, portal circulation, and     portal-systemic shunt and to derive a DSI in intact human subjects. HepQuant tests can assess     all stages and etiologies of liver disease. In chronic HCV patients HepQuant testing can     predict which patients will respond to antiviral therapy and can measure the improvement in     hepatic function that occurs after successful antiviral therapy. Patients who did not respond     were followed for an average of 5 years and up to 8 years, and baseline HepQuant testing     could predict clinical outcomes (CTP progression, variceal bleeding, encephalopathy, ascites,     liver-related death) with 87% sensitivity and 71% specificity.   "
59530|NCT02506322|"     This efficacy study compares an adjuvant specific psychotherapy and an active control     intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain     remission. Patients should be in their early (18-30 yr.) phase of illness without having     suffered of to many affective episodes (below 6), already. In addition, psychological,     social, and neurobiological mediators and moderators well be identified.   "
59531|NCT02506309|"     Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress     urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be     as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A     third generation of the MUS inserted through a single vaginal incision (SIS) has become a     means to overcome significant post-operative groin pain. Novel types of SIS with a more     robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the     obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an     innovative fixation SIS in randomized controlled trial on patients undergoing their primary     surgery for urodynamic SUI.   "
59532|NCT02506296|"     Patients with type 2 diabetes have very variable endogenous insulin secretion. While some     patients have relatively preserved endogenous insulin with marked insulin resistance others     may develop the very severe insulin deficiency seen in type 1 diabetes. The impact of this     variation on hypoglycaemia risk and treatment response in type 2 diabetes is unclear. This     project aims to determine the impact of residual endogenous insulin secretion on glucose     variability, hypoglycaemia risk and treatment response in insulin-treated participants with a     clinical diagnosis of type 2 diabetes. The investigators will recruit participants from     existing cohorts known to have severe insulin deficiency despite classical clinical     characteristics of type 2 diabetes. The investigators will recruit other participants with     insulin-treated type 2 diabetes and retained endogenous insulin secretion matched for     glycemia and gender. The investigators will assess glucose variability (using continuous     glucose monitoring system (CGMS)) and treatment response to a single dose of the glucose     lowering therapy vildagliptin and compare responses between groups. This study will allow us     to assess the potential utility of measuring endogenous insulin secretion in insulin-treated     type 2 diabetes as a marker of hypoglycaemia risk and in determining likely response to oral     therapy.   "
59533|NCT02506283|"     This study investigates the effects of cooling on the recovery and performance characteristic     in young healthy subjects. The study is divided in two projects:      Project A: investigates the effects of 20 min. post-exercise cooling on vertical jump     performance and delayed onset muscle soreness and rated perceived exertion.      Project B: investigates the effects of 20 min. pre-exercise cooling on maximal voluntary     contraction of the right M. quadriceps femoris and delayed onset muscle soreness and rated     perceived exertion.   "
59534|NCT02506270|"     The aim of the investigators' study is to investigate if the use of the AirSeal insufflation     system impairs ventilatory parameters of patients less than a conventional system in patients     undergoing robot-assisted laparoscopic cystectomy.   "
59535|NCT02506257|"     Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study     to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic     solution compared to placebo in healthy subjects   "
59536|NCT02506244|"     The purpose of this study is to investigate whether it is possible to identify a high-risk     cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and     then engage those individuals in a mobile health technology-enabled home monitoring program     in order to document previously undiagnosed atrial fibrillation, and provide clinical     evidence of an outcomes benefit associated with this early detection.   "
59537|NCT02506231|"     The purpose of this study is to assess the impact of folinic acid (FA) -rescue following     methotrexate (MTX) graft-versus-host disease (GVHD) prophylaxis on regimen related toxicity     and transplantation outcomes after allogeneic hematopoietic cell transplantation (alloHCT) in     a double blind randomized controlled trial.   "
74321|NCT02312947|"     Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold     dissection adenoidectomy specifically inquire which method is safer and more efficient.   "
59539|NCT02506205|"     A handful of studies have examined the effects of the Lee Silverman Voice Treatment (LSVT)     LOUD on hypokinetic dysarthria in English speakers with Parkinson's disease (PD). Although     LSVT LOUD has been found to be effective on improving these speaker's vocal intensity and     increasing their speech intelligibility as well as speech function with Phase I evidence, no     study has investigated whether Mandarin-speaking individuals with dysarthria secondary to PD     would benefit from LSVT LOUD. In the proposed study, speech data of Mandarin-speaking     individuals with hypokinetic dysarthria before and after speech therapy will be audio     recorded and analyzed in order to examine the effects of LSVT LOUD on the speech function in     this population. The same speech data will be played to Mandarin listeners in order to     investigate the speech intelligibility of this population. It is hypothesized that     Mandarin-speaking individuals with hypokinetic dysarthria secondary to PD will demonstrate     reduced vocal intensity, reduced speech intelligibility and impaired speech function before     they receive LSVT LOUD. They will improve these speech characteristics following speech     therapy and will present with short-term maintenance effects.   "
59540|NCT02506192|"     The primary objective of this clinical trial is to determine if treatment with an     anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of     life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change     from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes     measures include changes from baseline levels of GWI-associated biomarkers of inflammation in     peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment),     and HRQOL with respect to mental functioning.   "
59541|NCT02506179|"     To evaluate the real-life effect of adalimumab on psychological distress/depression symptoms     in moderate-to-severe Ulcerative Colitis (UC) patients   "
59542|NCT02506166|"     The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden     cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The     ESCAPE - SCD Study will address following specific study questions:        -  Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk          factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM)          indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC)          Guidelines for primary prevention of sudden cardiac death?        -  Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive          Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM          patients?        -  Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy          improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant?        -  Does obstructive sleep apnea represent a novel factor that may improve risk          stratification of sudden cardiac death and advance identification of those patients that          will benefit from ICD/CRT-D therapy?   "
60050|NCT02499562|"     To explore the effective dose and safety of the effect of hydronidone and entecavir on     hepatic fibrosis in chronic viral hepatitis B.   "
59544|NCT02506140|"     Ticagrelor is a reversible and direct-acting oral antagonist of the P2Y12 (Purinergic     receptor P2Y, G-protein coupled, 12) receptor for adenosine diphosphate, which provides     faster, greater, and more consistent P2Y12 inhibition than Clopidogrel in patients with acute     coronary syndrome, irrespective of the genetic variants affecting Clopidogrel metabolism. It     is still undefined whether combination therapy of Ticagrelor and Aspirin is more effective     than Clopidogrel and aspirin for minor stroke and transient ischemic attack (TIA). The     primary purpose of the PRINCE trial is to evaluate the anti-platelet effects of a 3-month     regimen of ticagrelor initiated with 180 mg loading dose followed by 90 mg twice/day combined     with aspirin 100 mg/day during first 21 days versus a 3-month regimen of clopidogrel     initiated with 300 mg loading dose of followed by 75 mg/day combined with aspirin 100 mg/day     during first 21 days when initiated within 24 hours of symptom onset in high-risk transient     ischemic attack or minor stroke.   "
59545|NCT02506127|"     This study will evaluate the effectiveness of intermittent Theta Burst Stimulation for     patients with Major Depressive Disorder.   "
59546|NCT02506114|"     This is a multicentered, open label, randomized phase II trial of PROSTVAC or ipilimumab or     the combination of PROSTVAC and ipilimumab as neoadjuvant therapy in patients with localized     PC. Eligible patients will be randomized to PROSTVAC monotherapy (Arm A), ipilimumab     monotherapy (Arm B), or combination therapy with both PROSTVAC and ipilimumab (Arm C), prior     to RP. In arms A and C, PROSTVAC-V will be administered subcutaneously as the primary vaccine     on Day 1, which will be followed 2 weeks later with a series of 2 PROSTVAC-F subcutaneous     administrations, given 3 weeks apart. In arms B and C, ipilimumab will be administered twice,     at a dose of 3mg/kg, 3 weeks apart. In the combination arm, ipilimumab administration will     coincide with the PROSTVAC-F administration. In arm B, ipilimumab will begin on Day 1. In all     three arms, RP will occur 21 days, or three weeks, following final treatment administration     of PROSTVAC or ipilimumab. No further therapy will be administered on study following RP.   "
59547|NCT02506101|"     The objective of this study is to assess the effectiveness and safety of     narrowband-ultraviolet B (NB-UVB) treatment in adult subjects with vitiligo.   "
59548|NCT02506088|"     The present research creates a partnership between researchers and a community agency to     evaluate whether a sexual assault prevention program for high school students reduces     perpetration of sexual violence among high school boys.   "
59549|NCT02506075|"     The primary objective of this study is to confirm and compare the effect of methods of     transcranial direct current stimulation(tDCS) in the unilateral neglect of stroke patients   "
59550|NCT02506062|"     This trial will test the efficacy of brief periods of controlled limb ischemia (remote     ischemic preconditioning, RIPC) as an effective treatment of patients with Raynaud's     Phenomenon (RP).The hypothesis of this trial is that due to its vasoprotective effects, RIPC     would be more effective than placebo in the treatment of both primary and secondary RP, as     defined by decreased frequency, duration, and severity of attacks. This trial was also     designed to monitor the tolerance of RIPC in a rheumatologic population. Patients will not be     required to stop any current treatment for RP.   "
59551|NCT02506049|"     Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser     photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).   "
59554|NCT02506010|"     The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation     comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood     saturation during non-motion conditions over the range of 60-100% SaO2 as measured by     Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements     will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.   "
59555|NCT02505997|"     The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on     the pharmacokinetic (PK) profile of a single oral dose of midazolam.   "
59556|NCT02505984|"     The purpose of this feasibility study is to test a new treatment for preventing     childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing     maternal bonding and reducing postpartum depression (PPD) and posttraumatic stress symptoms     in mothers at risk. To this end, the investigators will test the clinical utility of     intranasal oxytocin (IN-OXT) administered to mothers during the first postpartum days.   "
59557|NCT02505971|"     The purpose of this study is to assess the efficacy and safety of oral propranolol versus     nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled,     double-blinded study.   "
59558|NCT02505958|"     Objective: To show that a 1-2 day reduction of caloric intake can reduce the insulin     resistance produced by several days of overnutrition. Approach: Healthy volunteers will be     admitted to the Clinical Research Center and undergo a baseline euglycemic-hyperinsulinemic     clamp study to assess their insulin resistance. Subjects will then start on an overnutrition     program for 4 days consisting of 3 meals and 3 snacks containing ~6,000 Kcal/24hours. A     second clamp study will be performed on day 5 to demonstrate the overnutrition induced     increase in insulin resistance. Starting on day 5 the subject's caloric intake will be     reduced to ~1,000 Kcal for 2 days (day 5 and 6). After that on the morning of day 7, a third     hyperinsulinemic-euglycemic clamp will be performed to determine whether the reduced caloric     intake did reduce insulin resistance and the volunteer will be discharged from the Clinical     Research Center.   "
59559|NCT02505945|"     This study compares mechanical sphincter augmentation (LINX Reflux Management System) to     double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to     gastroesophageal reflux disease (GERD).   "
59678|NCT02504398|"     Vaccine injections are a significant source of pain for infants. Altering the injection speed     when administering vaccines may be an effective intervention and is feasible (cost neutral).     At present, there are no data regarding impact of injection speed on vaccine injection pain     in infants. The aim of this study is to address this knowledge gap and to compare the impact     of slow and fast vaccine injection speeds on pain during routine infant vaccinations.   "
59562|NCT02505906|"     In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment     technique for early breast cancer. Radiotherapy has shown to give better local control and     survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB)     technique is a new treatment technique in breast irradiation. In this technique the whole     breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late     radiation-induced toxicity has not been investigated in patients treated with radiotherapy     using this technique. Proposed study will study the late radiation-induced toxicity, describe     patients-rated complaints, quality of life, survival and local control curves in patients     treated for early breast cancer with breast-conserving surgery in combination with     radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.   "
59563|NCT02505893|"     This is a prospective phase 2, single-arm, mono-center pilot study. It has been designed to     investigate whether giving the combination therapy consisting of minimal islet     transplantation (1500 EIQ/Kg body weight), Thymoglobulin® (ATG), Rapamune® (rapamycin) and     Neulasta® (pegfilgastrim) to patients with Type 1 Diabetes (T1D) at onset is safe and     secondarily, if it will preserve insulin production. It will involve 6 patients with     new-onset T1D. Each patient will be involved in the study for a screening period and a     post-islet transplantation study period of 52±2 weeks, to include 1 treatment cycles of 12     weeks, assessment during treatment and 5 follow-up visits scheduled at weeks 2±1 (14 days),     4±1 (month 1), 12±2 (month 3), 26±2 (month 6) and 52±2 (month 12).   "
59564|NCT02505880|"     In adults, it is common to perform a number of superficial and non invasive surgeries under     local anesthesia in order to limit the use of general anesthesia.      Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the     patient comfort and experience. The benefit of this practice has been widely demonstrated in     adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and     vomiting.      In pediatric surgery, hypnosis is an effective technique for the management of preoperative     anxiety. It is used by many teams in their daily practice, particularly during anesthetic     induction.      For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University     Hospital also offers for selected short and superficial non-invasive surgeries, an     intraoperative management under hypnosis in association with ocal anesthesia as an     alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted     and recognized in our intraoperative surgical unit, to date, no studies have evaluated the     benefits of this technique compared to general anesthesia.      The objective of the study is to compare the impact of these techniques (hypnosis vs. general     anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain,     nausea and vomiting, negative behavioral disorders).   "
59565|NCT02505867|"     The purpose of this study is to evaluate the effect of in-hospital diagnosis and treatment of     sleep disordered breathing (SDB) on post-discharge mortality and readmissions in-     hospitalized patients with acute heart failure syndrome and reduced ejection fraction     (HFrEF).   "
59566|NCT02505854|"     The purpose of this study is to evaluate whether contribute with weight loss and improvement     of blood sugar and lipemia in obese women.   "
59567|NCT02505841|"     The transversus abdominis plane (TAP) block is a regional anesthetic technique for post     operative pain control after abdominal surgical procedures. Its effectiveness in children     undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate     its analgesic efficacy over the first 24 post operative hours.   "
59760|NCT02503332|"     The primary objectives of the study are to assess the safety, tolerability and evidence of     activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic     Atrophy associated with Age-Related Macular Degeneration (AMD).   "
59568|NCT02505828|"     The aim of this study is to find markers that could differentiate infectious and inflammatory     arthritis. The investigators want to find markers by differential analysis by compare     synovial fluids of septic and inflammatory arthritis. The investigators will use for this     analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The     investigators will use one marker or a score with biological and clinical data to     discriminate arthritis of infectious and inflammatory etiology.   "
59569|NCT02505815|"     Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory     function and intellectual skills, which occurs after surgery with and without anesthesia. The     POCD strongly depends on patient's age and the surgical operation type. The anesthesia     procedure plays a pivotal role as well and regarding the current knowledge it is still     uncertain which technique matches the lowest risk. Elevated stress level accompanied with     regional anesthesia procedures are accused to cause POCD in elderly patients. The     investigators address the question weather regional or general anesthesia leads to a     pronounced POCD in dependence of stress incidence.   "
59570|NCT02505802|"     Botulinum toxin A (BoNT-A) injections are widely used to treat spasticity after stroke.     Although this treatment is effective on muscle tone improvement, its effect on gait and     ability of daily living on early stage of stroke adults remains uncertain.The purpose of this     study is to determine whether an early calf muscle injection of low dose BoNT-A in severely     affected patients within 6 weeks after stroke could help to hold back disabling muscle     spasticity and improve walking dysfunction.   "
59571|NCT02505789|"     In many countries, numerous steps are taken to minimize the risk of infection from transfused     blood products. Typically, blood banking organisations will screen for an array of infectious     pathogens as part of their quality control protocol. While transmission of these tested     agents via transfusion has become exceedingly rare, the risk of transfusion-transmitted     infections for which testing is not currently performed continues to be a concern. Among     these untested infectious agents is Epstein-Barr virus (EBV, also known as human     herpesvirus-4). Most notably, infection with this virus in transplant recipients can give     rise to a malignant disorder called post-transplant lymphoproliferative disease (PTLD), a     life-threatening complication which is due to the uncontrolled expansion of EBV-infected     cells. It is also associated with other complications such as hepatitis, hemophagocytic     syndrome, etc. in transplant population. It is recognised that EBV infection can occurred in     transfused immune suppressed graft recipients but the origin of the viral infection is still     a matter of debate. It is a known fact that the EBV already present in the recipient's blood     can undergo reactivation due to immune suppression. However, because it is known to occur     more frequently in patients who are EBV-seronegative at the time of transplant, it is also     accepted that primary infection contracted via an infected graft can be a source of virus.     The question we are seeking to answer is whether immune suppressed graft recipients can     acquire primary EBV infection via transfusion of blood products. EBV is present in the blood     of most adults and cases of EBV transfusion-related infection have been reported. Transplant     populations are generally transfused with very large volumes of blood products and our recent     pilot study supports the possibility that transfusion-related EBV infection can be     transmitted to pediatric hematopoietic stem cell (HSCT) recipients (Trottier et al, 2012).     The aim of this study is to analyse the risk of EBV transmission through blood product     transfusion in pediatric allogeneic HSCT patients.   "
59572|NCT02505776|"     This is a post-marketing surveillance study in Japan that will evaluate the safety and     patient satisfaction with GLASH VISTA™ (bimatoprost cutaneous solution 0.03%) in the     treatment of hypotrichosis of the eyelashes.   "
59574|NCT02505750|"     The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm     using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy     (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be     organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of     this concept will be of most benefit for all patients but especially for the elderly who     usually are not fit for or keen to undergo major surgery.      The hypothesis of this study is to determine whether the addition of an endocavitary boost     with CXB after standard treatment with nCRT, increases the chance of rectum and anus     preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease     (organ preservation in control arm 20%, in experimental arm 40%).      Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost     given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT     alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease     at 3 years post treatment start, or permanent deviating stoma.      Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1,     2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.   "
59575|NCT02505737|"     There is a critical need for treatments that address depression and barriers to mental health     care in Parkinson's disease (PD). This randomized-controlled trial will evaluate a 10-session     telephone-guided cognitive behavioral self-help program (TH-CBT) for depression in PD (dPD).     72 people with dPD (and their caregivers) will receive either TH-CBT plus enhanced usual care     (INTERVENTION GROUP) or enhanced usual care only (CONTROL GROUP). Groups will be compared at     baseline, midpoint, endpoint, and 1 and 6 months post-treatment. Participants assigned to the     control group with have the opportunity to receive the experimental intervention (TH-CBT)     after the data collection period (e.g., after the 6-month follow-up evaluation). Given the     public health impact of improved depression treatment in PD, the knowledge to be gained may     be significant and the project could directly impact clinical practice.   "
59576|NCT02505724|"     This single-blinded randomized controlled trial assesses the efficacy of peer-coaching to     teach novice surgical faculty an advanced laparoscopic skill.   "
59577|NCT02505711|"     The aim of this study is to evaluate the potential of reducing young child undernutrition in     low-income countries through an integrated program that trains women's groups in agriculture,     nutrition, child care and hygiene.   "
59601|NCT02505399|"     Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly     calcified atherosclerotic coronary lesions. It aims at fragmenting calcium deposits into     microscopic particulates to allow less hazardous coronary revascularization and stenting. The     main drawback associated with the procedure is the subsequent enhancement of platelet     aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic     fragments. In order to limit these complications, a double antiplatelet therapy is required     (generally Clopidogrel + Aspirin) when RA procedures are performed. Clopidogrel inhibits the     protein P2Y12 which is a cornerstone in platelet aggregation. Ticagrelor is a new     antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel. It is     currently indicated to reduce risk of cardiovascular events in patients hospitalized for     coronary revascularization after an acute coronary syndrome. Ticagrelor has never been     evaluated so far in stable coronary patients treated with rotational atherectomy prior to     angioplasty.   "
59578|NCT02505698|"     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology     using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D     metabolic maps of the breast and based on sophisticated machine learning technology, provides     objective risk assessment for the presence of malignant tumor in the breast. The procedure is     non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring     infrared images of the breast. Those images are processed and analyzed by computers to     provide the objective risk assessment.      The technology is intended to be used as a screening tool for breast cancer and emerges as     highly useful in women for whom screening mammography is sub-optimal, such as women with     dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating     patients with mammographically dense breasts.      Real Imaging is continuously developing the technology including image acquisition hardware     and objective analysis of the imaging biomarkers. To further improve and optimize this novel     metabolic imaging technology, Real Imaging will introduce an improved imaging device.      The purpose of this clinical study is to collect more imaging data in order to establish     superiority of the newer device over the previous one.      The investigators hypothesize is that the new device will be at least as good as the previous     one.   "
59579|NCT02505685|"     The purpose of this study is to evaluate the use of Dynamic PET/CT as a tool to assess     disease response to anti-cancer therapy in Lung Cancer patients.   "
59580|NCT02505672|"     Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects     of this treatment on cochlear function is well characterized, its effect on vestibular     function is not well studied.      In this study the investigators will study the vestibular function of 50 patients undergoing     chemoradiotherapy for NPC both before and after treatment in order to better define its     effects. All patients will undergo a validated questionnaire (dizziness handicap index),     posturography, audiometry and vestibular-evoked myogenic potentials.   "
59581|NCT02505659|"     Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to     functional deficits which are difficult to overcome. To prevent from an unfavorable     evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very     common. Knee functional performance level could impact on the postoperative outcome and it's     of common knowledge that early re-education after an ACR rupture improves knee functioning.      Patients with an ACR rupture enrolled in this study will be randomized either in an     experimental group (with preoperative reeducation) or in a control group (without     preoperative reeducation). Both groups will then have post-operative re-education (40     sessions) based on HAS recommendations.      The main aim of this study is to assess the impact of preoperative re-education on knee     functional performance 4 month after surgical reconstruction of an ACR.      Secondary aims are to determine the impact of the 4-week preoperative re-education on knee     functional performance after an ACR rupture, before surgery and 7 months after surgery.      Functional performance, muscular strength, proprioception and anterior knee laxity will be     measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M)     after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the     previous assessments.   "
59598|NCT02505438|"     Maintaining muscle mass and function is important in healthy ageing to maintain quality of     life. Loss of muscle mass is major problem, as beyond the age ~50, muscle mass declines by     ~1-2% a year. To prevent this loss, the investigators need to understand the mechanism     regulating muscle mass as we age. In this project the investigators aim to determine these     mechanisms using a new technique of heavy water ingestion, this allows measurement of     multiple aspects of skeletal muscle mass metabolism e.g. protein synthesis, over long periods     (6 weeks) as people go about their normal everyday activities. The investigators also aim to     determine the influence of resistance exercise training on older muscle, as well as     differences between men and women in muscle responses to exercise and nutrition HMB     (beta-hydroxy-beta-methylbutyrate).   "
59582|NCT02505646|"     Purpose:      Fluid responsiveness in a context of circulatory failure can be predicted by different way.     Dynamic criteria such as pulse pressure variation, stroke volume variation during an     end-expiratory occlusion maneuver or a passive leg raising have been reported to predict     fluid responsiveness. Only aortic velocity peak variation measured with transthoracic     echocardiography during mechanical ventilation has been reported to predict fluid     responsiveness in children. Besides some physician use a maneuver of abdominal compression to     predict fluid responsiveness in children with circulatory failure. This strategy has never     been formally evaluated.      The investigators will study the diagnosis accuracy of the stroke volume variation induced by     an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in     children with circulatory failure.      Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the     attending physician has decided a fluid load will be included. Hemodynamic parameters:     arterial pressure, heart rate, stroke volume measured with echocardiography; will be     recorded. This data collection will be performed before, after abdominal compression and     after a fluid load of 10 ml/kg.      Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders.     Fluid responders are defined as patients that show an increase greater than 15 % in stroke     volume. The diagnosis ability of the Stroke volume variation after an abdominal compression     to predict fluid responsiveness will be investigate and receiving operative characteristic     (ROC) curve will be built. The correlation between the variation of stroke volume during     abdominal compression and during the fluid load will be studied. Other parameters such as     arterial pressure and heart rate will also be investigated.   "
59583|NCT02505633|"     Ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) has been a generalized     regional anesthesia in upper extremity surgery. It is performed just above the clavicle, in     which the neural cluster formed by the trunks or divisions of the brachial plexus is situated     superolateral to the subclavian artery (SA).      In many approaches, corner pocket approach [deposit local anesthetic (LA) at the intersection     of the SA, neural cluster, and the first rib] and cluster approach (direct deposit LA into     the neural cluster after penetration of the sheath of brachial plexus) has been well known     methods. And single or multiple injection techniques has been used with the above approaches.   "
59584|NCT02505620|"     Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway     obstruction while sleeping. Upper airway obstruction while sleeping leads to a dramatic     decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient     rapidly awake. Clinical signs are sleepiness and functional cognitive deficits. The Gold     standard therapy is continuous positive airway pressure ventilation during sleep. However,     the success depends strongly to the patient´s compliance. Surgical treatment is an     alternative option, which could be considered if clinical success failed. A comparison of the     cognitive function of both therapies is not yet analyzed. The study addresses the question     which of this treatment options is favorable regarding cognitive function and outcome.   "
62451|NCT02468180|"     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection     versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric     variceal bleeding.   "
59585|NCT02505607|"     Overactive bladder (OAB) is a common, chronic condition, characterized by urinary urgency,     with or without urge incontinence, usually with frequency and nocturia. Treatment adherence     is a major barrier to management of OAB and drug continuation is poor. Many factors may play     a role in non-adherence to medication management of OAB including drug cost, side effects,     and a lack of understanding of the disease and treatment process.Studies show that recall of     disease information and treatment is often suboptimal. Literature shows that providing     written materials is an efficacious way to aid in recall. Based on known poor adherence to     OAB medication treatment and the clear role patient education methods have on patient     information recall, the investigators believe that improvement of participant education     through use of a OAB care plan will improve participant understanding and treatment     adherence.      Through this randomized trial, the investigators plan to evaluate whether implementation of a     OAB Care Plan improves understanding of disease and treatment options, treatment success, and     satisfaction.      This is a prospective, randomized, controlled study of OAB counseling in new patients     presenting to the Urogynecology offices of Hartford Hospital. All new patients with a     diagnosis of OAB will be offered participation. All consenting participants will be     randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the     Standard Care group, participants will be counseled as the physician routinely counsels     patients about OAB, in the Care Plan group, participants will be counseled a printed     Overactive Bladder Plan of Care information sheet. At the end of the visit, the participant     will complete a Baseline Survey. The Baseline Survey includes basic demographic information,     a physician satisfaction survey, and a OAB knowledge survey. The participant will return for     follow up as directed by the physician.      At the follow up visit, participants in both groups will complete a Followup Survey. The     Followup Survey will be completed before the participant sees the physician. The Followup     Survey assesses OAB knowledge.      Eight months after the baseline visit, each participant's chart will be reviewed for final     data collection. If a participant progresses to a treatment method where she is satisfied and     would like to remain, this will be documented.   "
59586|NCT02505594|"     Obstructive sleep apnea (OSA) is a common disorder with major cardiovascular sequelae. A     recent study confirmed that OSA is associated with impaired exercise capacity and increasing     OSA severity predicts worsening exercise capacity, which is a marker of potential increased     cardiovascular risk. However, potential mechanisms of decreased exercise capacity caused by     OSA remain unclear. Several pathophysiologic mechanisms of OSA have been proposed and     investigators hypothesize that endothelial dysfunction leading to exercise-induced right     ventricular dysfunction and associated pulmonary hypertension is the potential mechanism for     impaired exercise capacity in OSA.   "
59587|NCT02505581|"     Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be     used.      Experimental group: Patients undergoing elective colorectal surgery that involves, colonic     resection.      The antibiotic prophylaxis in this group will be composed of:      An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg /     8h, 3 doses) the day before surgery.      Control group: Patients undergoing elective colorectal surgery that involves, colonic     resection.      The antibiotic prophylaxis in this group will be composed of:      An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic     induction.      In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the     intraoperative time elongates more than three hours or there is an intraoperative bleeding     over 1000cc.      There won´t be a placebo treatment. Subject compliance will be evaluated according to the     usual practice in surgical care field   "
59588|NCT02505568|"     The purpose of this study is to evaluate the efficacy of infliximab in induction regimen by     assessing the mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD)     score of 20 or more in participants with active intestinal Behcet's disease who are     refractory to conventional therapies.   "
59589|NCT02505555|"     The purpose of this study is to summarize our experience with and to evaluate the feasibility     of transvaginal four-dimensional hysterosalpingo-contrast sonography using SonoVue     (4D-HyCoSy) for assessment of fallopian tubal patency, women attending the fertility clinic     are recruited. All of the patients are tried to be examined with 4D-HyCoSy,some of who     undergone laparoscopy and dye. Then the results of 4D-HyCoSy and lap and dye are compared.     All of the patients will be followed up. The complications of 4D-HyCoSy will be evaluated and     the pregnancy outcomes will be recorded.   "
59590|NCT02505542|"     Patients receive study drug for one year (Part A). If, after the initial run-in phase, a     sustained remission is reached they will be randomly split into one of three dose groups for     another year (Part B). The maintenance of the sustained remission will be analyzed.   "
59613|NCT02505243|"     The aim of this study is to evaluate RBV plasma concentrations when used in combination with     newly developed DAA combinations. If possible, its correlations with SVR rates and incidence     of anaemia will be assessed in HCV-patients.   "
59591|NCT02505529|"     The UNCODE Study seeks to better identify the neurological causes of muscle weakness     associated with advancing age. The main study consists of 4 laboratory-based testing sessions     that involve testing muscle strength and physical and cognitive function as well as a battery     of tests to 1) quantify brain excitability (using non-invasive transcranial magnetic     stimulation), 2) modulate brain excitability (using non-invasive transcranial direct current     stimulation), 3) spinal motor nerve firing characteristics, and 4) brain structure and     function characteristics based on magnetic resonance images of the brain. Additionally, three     option sub-studies are also available for enrollment. The first is a genetics sub-study where     a cheek swab will be used to examine associations between certain genes and the physiological     and functional measures obtained from the main study. The other two sub-studies are     interventions. The first sub-study is a progressive resistance exercise training study where     study participants will undergo 12-weeks of exercise training (3x/wk) and at the completion     of the exercise training the measures obtained in the main study will be re-assessed. The     other sub-study is a mental imagery sub-study where subjects are randomly assigned to perform     a mental imagery training program consisting of imaging strong muscle contractions and     mobility tasks (5x/wk) or to serve as a control (i.e., to not modify lifestyle) for 6-weeks.     At the completion of the respective intervention period the measures obtained in the main     study will be re-assessed.   "
59592|NCT02505516|"     patients om metformin from diabetic clinic were checked for bladder cancer   "
59616|NCT02505204|"     Paravertebral block (PVB) combined with light intravenous sedation was associated with a     short hospital stay, less post-operative nausea and vomiting and reduced analgesic     consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness     of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with     versus without clonidine in elderly patients.      Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the     sealed envelope technique. Group one will receive PVB with clonidine while group 2 will     receive PVB with placebo.   "
59617|NCT02505191|"     A pilot phase I, randomised, open mono-center, two parallel group clinical trial     investigating the pharmacokinetics of a prolonged-release formulation in comparison to an     immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers     under fasting condition.   "
59593|NCT02505503|"     Some people experience a cramp-like leg pain during walking that is relieved only by rest.     This is called intermittent claudication (IC) and it is a common symptom of peripheral     arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of     life.      The intensity of IC pain experienced during walking depends on several factors, including the     type of footwear worn. For example, non-supportive shoes may make the calf muscles work     harder during walking, leading to earlier and more-severe symptoms of IC.      A member of the research team has developed a shoe that reduces the work done by the     lower-leg muscles during walking. Preliminary data indicate that, when wearing these     unloading shoes, people with IC were able to walk further without pain as compared with     when wearing a normal pair of shoes. The current project aims to provide further information     on the usefulness and acceptability of these shoes.      Forty people with IC will complete a set of three walking tests on two separate occasions;     once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The     participants will then be given a pair of unloading or normal shoes to wear for two weeks,     after which we will collect information on how acceptable the shoes were to wear via a survey     of all participants and one-to-one interviews with a subset of participants.   "
59594|NCT02505490|"     The purpose of the study is to investigate the effect of television viewing on liking of     food.   "
59595|NCT02505477|"     The purpose of this study is to attempt to treat cognitive and negative symptoms of     schizophrenia, with the nutritional supplement N-acetylcysteine (NAC).      Schizophrenia is a chronic mental disorder that affects approximately 65 million people     worldwide, and causes significant disability and suffering. Patients with schizophrenia often     hear voices and have persecutory delusions. Though these are the most recognizable features     of the illness, the deficits most closely linked to disability are known as cognitive     deficits and negative symptoms. Cognitive abilities refer to the ability to perform mental     tasks that require focus and attention, and also include memory and verbal skills. Negative     symptoms refer to a lack of interest in the world, and decreased social interactions. In our     study, the investigators aim to improve these symptoms and deficits by targeting the     glutamate system.      Glutamate is the major excitatory neurotransmitter in the brain, and its regulation is     abnormal in schizophrenia: glutamate levels are too low at some receptors, and too high at     others. As well, free radicals surrounding glutamate receptors also interfere with their     proper function. N-acetylcystine (NAC) is a safe and widely-available dietary supplement that     may restore glutamate to its correct levels in the brain, and may also help protect the brain     from antioxidant damage.      In our study, patients with schizophrenia will be randomly assigned to receive either NAC or     placebo for 8 weeks. Brain levels of glutamate and an important antioxidant, glutathione,     will be measured before and after treatment, using a neuroimaging technique known as magnetic     resonance spectroscopy. Cognitive and negative symptoms will also be assessed before, during     and after treatment. The investigators hypothesize that glutamate and glutathione will be     normalized in patients' brains, and that their negative and cognitive symptoms will be     improved, too.   "
59596|NCT02505464|"     The focus of this research is to create a repository of ultrasonographic images and their     corresponding medical data from pregnant women (the mothers of the fetuses that are imaged),     focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One     Health and the Le Bonheur Fetal Center.   "
59597|NCT02505451|"     Summary.      Theoretical Rationale:      The left ventricular myocardial performance results from a complex interplay between linear     deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. These     components of myocardial mechanics can be assessed, at rest and during stress conditions, by     high resolution echocardiography using the 2D-strain technology and constitute good indexes     of tissue intrinsic contractility / relaxation properties. Type 2 diabetes (T2DM) and     metabolic syndrome (MS) are associated with an increased risk for cardiac diseases. While     several clinical studies have reported, particularly in T2DM, a diastolic dysfunction     (concept of diabetic cardiomyopathy), the existence of impaired regional myocardial     function, with altered intrinsic contractility properties, remains largely unanswered,     especially in the SM. Stress echocardiography is very interesting to reveal myocardial     dysfunction, discrete or absent at rest. To the best of our knowledge, no scientific study     is, however, today available on the kinetics of linear strains and twist/untwist dynamics in     response to stress in T2DM as well as SM. The epicardial adipose tissue is the source of     production of important pro-inflammatory cytokines that have the potential, through an     exacerbation of oxidative stress, to impair coronary endothelial function, increase fibrosis,     but also directly affect cardiomyocyte calcium homeostasis. An increase in epicardial adipose     tissue is consensually reported in T2DM and SM and is clearly associated with coronary     atherosclerosis. A link between cardiac adiposity and overall cardiac function, particularly     diastolic, is now suggested but to our knowledge no study has challenged its association with     myocardial dysfunction in T2DM as SM patients.      Objectives and Methodology: - To investigate regional myocardial linear deformations and     torsion, at rest and in response to a dobutamine stress, in asymptomatic T2DM and SM patients     without clinical complications, - to study the links between expected regional myocardial     abnormalities and inflammation, hyperglycemia and cardiac adiposity. A control group of     healthy individuals matched for sex and age will also be included.      All the subjects will benefit from a clinical, anthropometric and biological evaluation. In     addition, conventional echocardiography (remodelling and global diastolic and systolic     functions) complemented by a functional analysis by tissue Doppler imaging will be performed.     Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the     objective assessment of myocardial longitudinal deformations as well as in the parasternal     short axis (base and apex) for the evaluation of the circumferential deformations and basal     and apical rotations and left ventricular torsion, at rest and under low dose of dobutamine     (110 and 120 bpm).   "
59614|NCT02505230|"     This study will investigate the energy consumed from an entree with high- or low-volume     vegetables incorporated into the entree or served along side of the entree, in normal weight     adults.   "
59725|NCT02503787|"     The purpose of this study is to evaluate programming options in spinal cord stimulation for     the management of chronic, intractable pain of the trunk and limbs.   "
59726|NCT02503774|"     The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics,     Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in     Adult Subjects with Select Advanced Solid Tumors   "
59599|NCT02505425|"     Advanced heart failure affects nearly 6 million Americans, and less is known about how this     illness affects the 80% of heart failure patients who are 65 years and older because research     tends to focus on younger patients. Older patients with heart failure and their family     caregivers, rarely have access to palliative supportive care services because the disease is     unpredictable and palliative treatment may not be provided until after other medical     treatments have been tried. Investigators are studying whether palliative care provided when     advanced heart failure patients are still well will result in better quality of life, mood     and less symptom distress compared to usual or standard heart failure care.      Specific Aims and Hypotheses:      Specific Aim 1: Determine whether ENABLE: CHF-PC leads to higher advanced heart failure     patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom     burden and resource use (e.g. hospital admissions and days, emergency visits) at 8 and 16     weeks after baseline.      • Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower     symptom burden and resource use at 8 and 16 weeks after baseline compared with those     receiving usual HF care.      Specific Aim 2: Determine whether ENABLE: CHF-PC leads to higher caregiver-reported QOL, mood     (anxiety/depression), and self-reported health and lower caregiver burden at 8 and 16 weeks     after baseline.      • Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported     health, and lower caregiver burden at 8 and 16 weeks after baseline.   "
59602|NCT02505386|"     In geriatric departments, physicians are faced with two difficulties, first the increasing     number of infections caused by multiresistant bacteria, especially extended spectrum     β-lactamase (ESBL) producing enterobacteria strains and second, the poor venous access     frequently encountered in elderly population. Giving antibiotics subcutaneously would be an     interesting alternative, all the more as intramuscular injection is contraindicated in case     the of anticoagulant therapy. Unfortunately, few data are available about subcutaneous (SC)     administration. Ertapenem is a recent long-acting parenteral carbapenem indicated especially     in the treatment of ESBL infection. Its subcutaneously administration has been tested in     several studies in Intensive Care Units (ICU) and internal medicine wards with promising     results regarding clinical and pharmacokinetics data.      An alternative to the IV Ertapenem administration is needed because of poor venous access and     behavioural abnormalities commonly present in infected elderly population. Ertapenem is     currently SC administrated in geriatric departments if no other option is available. Moreover     elderly patients often present several comorbdities, polymedication, renal insufficiency,     cachexia which may disturb antibiotics pharmacokinetics.      The aim of the study is to obtain pharmacokinetic data of SC and IV Ertapenem administration     in elderly population, obtain PK/PD parameters adapted to time-dependent antibiotics (T%>MIC)     and descriptive data of occurrence of adverse effects and evolution of signs of infection.   "
59603|NCT02505373|"     Objective      Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence     of the effectiveness of follow-up treatments for these patients is limited. The authors     evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a     novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP     consists of three sessions followed by regular letters for 24 months.      Method      In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention     or a control group that received a one-session clinical assessment. Both groups received in-     and outpatient treatment as usual. Study participants also completed a set of psychosocial     and clinical questionnaires every 6 months during a 24-month follow-up period.   "
59604|NCT02505360|"     We seek to compare biochemically and histologically the nasal cartilage and ear in the     newborn cleft lip and slot carrier in order to improve the quality of care and patient     comfort after surgery of cheilorhinoplasty which is the primary treatment slots .      The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by     immunohistochemistry and study of mRNA and then they are compared according to the type of     cartilage.      This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip     and operated in the neonatal period.      Given the difficulty and constraint of time it takes to reach the 20 subjects of our study ,     we will also add to our population the stillborn babies before 25SA and newborns who die     before the age of 28 days and having had an autopsy.   "
59626|NCT02505074|"     The Melody valve has historically been used for pulmonary valve replacements; however it has     been more recently used in the mitral and tricuspid positions. This multi-center,     retrospective, observational study will review the durability of the Melody valve inserted     into the mitral or tricuspid positions.      Patients who have undergone Melody valve insertion into either the mitral or tricuspid     positions prior to December, 2014 will be eligible for the study. Basic de-identified patient     demographics will be collected as well as select clinical data. Ventricular function and     valvar function of the affected valve will be retrospectively reviewed both prior to surgery     and following, as well as review of operative data. The investigators will also review the     most recent follow up data and any subsequent re-interventions on the Melody valve. Data from     all sites will be entered into an external REDCap database, using only de-identified data.   "
60051|NCT02499549|"     To assess the efficacy and safety of 10% Cocamide DEA using two treatment regimens in the     eradication of head lice. To assess the ability of each treatment regimen to kill all viable     ova and to assess patient acceptability of the product in use   "
59605|NCT02505347|"     Distal biceps ruptures occur most commonly among young males in their third and fourth decade     of life. These injuries are becoming more common, however, as the aging population is     remaining active through sport or labour demands. Distal biceps tears or ruptures follow a     heavy eccentric load being placed on a shortened or flexed muscle, and often require surgical     repair. Functionally, distal biceps injuries cause impairment as this portion of the muscle     is largely responsible for supination and flexion at the elbow. Currently there is no     consensus regarding post-operative immobilization protocols, and little evidence is available     regarding timeframe for early return to functional activities. Existing evidence on     functional outcomes post distal biceps tendon repair (DBTR) is of low quality with small     sample sizes, and no known RCTs exist comparing early mobilization to immobilization on     functional return. Reported timeframes for immobilization range from early controlled motion     on day 1 post-operatively to complete immobilization for 6 weeks.      The primary study goal is to determine the effect of immobilization compared to unrestricted     mobility post DBTR on early functional return to activities. It has been previously reported     that those with DBTR related to a workers compensation injury returned to full duties in 3.95     months, while those with a non-workers compensation related injury returned to full work     duties in 1.35 months. In Alberta, near 100 WCB claims were made for DBTR in both 2013 and     2014. Early mobilization of these repairs may allow an earlier return to modified and full     work duties, thereby improving the functional quality of life of the individual as well as     reducing the overall cost of disability payments.      This study will assess the 1) time to return to pre-injury work level and 2) time to return     to modified duties among those who have no movement restriction post-repair and those who are     splinted for 6 weeks. Re-rupture rates between groups will also be assessed as will strength,     range of motion (ROM) and quality of life. These findings will assist in developing a     standardized protocol for immobilization to optimize functional and clinical outcomes while     expediting return to work.   "
59606|NCT02505334|"     This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety     of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes     mellitus.   "
59618|NCT02505178|"     This study seeks to determine the feasibility and efficacy of a Problem Solving Therapy     intervention for the treatment of late life depression (LLD). Participants diagnosed with LLD     will participate in six sessions of Problem Solving Therapy, a form of talk-therapy, over a     period of eight weeks. A Case Manager (CM) will lead the PST. The primary outcome measure is     depression severity and will be measured throughout the study at weeks 0, 4, and 8. the     secondary outcome measure is quality of life and will be measured at week 0     (pre-intervention) and week 12.   "
59619|NCT02505165|"     The purpose of this study is to test the efficacy of a clinic-based intervention designed to     reduce illness uncertainty for parents of children who have been recently diagnosed with     cancer.   "
59620|NCT02505152|"     To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for     treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.   "
59607|NCT02505321|"     The adipose (fat) cells under the skin are where individuals store excess fat. The more     excess fat they have, the more strain they put on these cells which then get bigger and     don't work as well as they should. Having some fat under the skin is important. People who     have a genetic defect which results in them having almost no fat under their skin have a very     high risk of a condition called insulin resistance (where the body does not respond as well     to insulin and blood sugar levels rise). This can lead to diabetes and heart disease despite     them not being overweight.      Scientists have only recently started to understand the importance of fat in insulin     resistance and how people unable to store fat very well can have insulin resistance despite     not being obese. The investigators have also recently discovered that small changes in a     person's genetic code (their body's instruction manual) may also affect their ability to     store fat and would like to explore this in more detail. To do this, they will recruit     volunteers from the Exeter 10,000 study who gave permission to contact them about further     research. The investigators will collect detailed body size measures and blood samples taken     before and after a special drink that is high in fat (similar to a thick milk shake), then     compare the results between people with and without the particular genetic changes of     interest.      Knowing more about these genetic changes and how fat cells work could help to improve     understanding about why some people develop diabetes and heart disease despite a relatively     normal BMI.   "
59608|NCT02505308|"     Defects in insulin secretion are central to the pathogenesis of type 2 diabetes (T2D) but the     molecular basis and physiological consequences of those defects are poorly understood,     impeding efforts to develop novel therapeutic approaches. Key questions remain unanswered,     such as the extent to which T2D-associated islet dysfunction reflects endogenous defects in     beta-cell mass or function, as opposed to disruption of external factors impinging on the     beta-cells, such as incretins.      Recently the investigators have identified several genetic variations (DNA changes)     associated with the production and processing of insulin in non-diabetic individuals and now     aim to explore in more detail the role of these genetic variations. Utilising a recruit by     genotype approach, they will identify individuals with and without genetic variants of     interest from existing databases of research volunteers. The investigators will collect     detailed medical history and measurements, fasted and stimulated blood samples for the     profiling of insulin-related hormones and metabolites. The resulting genetic and non-genetic     data will be used to improve understanding of the role of genetic variation on insulin     secretion and sensitivity defects that lead to the development of T2D.   "
59609|NCT02505295|"     Selenium is a trace element essential to human health.Selenium protection against cellular     damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is     associated with the generation of oxygen free radicals resulting in a condition of oxidative     stress. Supplementing stroke patients with antioxidant nutrients may improve survival.   "
59610|NCT02505282|"     Postural hypotension is common in older people, leading to falls, decline in function, and     dependence. Available treatments have limited efficacy and tolerability; novel approaches to     treatment are therefore needed. Decreased vascular health, stiffening of the arteries and     consequent decreased vascular reactivity are thought to contribute to postural hypotension     and are therefore therapeutic targets.      Recent trial evidence has suggested that vitamin K may exert beneficial effects on vascular     health particularly in respect to inhibiting calcification. Calcification increases vascular     stiffness, decreases compliance and thus decreases the ability of blood vessels to     autoregulate blood pressure and flow - which could contribute to postural drops in blood     pressure. Worsened vascular health could also impact adversely on baroceptor function, which     is needed for blood pressure autoregulation and which is disrupted in patients with     orthostatic hypotension.      Vitamin K intake is below recommended daily intake in 60% of adults in the UK. In animals,     vitamin K supplementation may be able to reverse calcification of arteries, and in humans     Vitamin K has been shown to arrest decline in carotid artery elasticity compared to placebo.     High levels of circulating vitamin K were also associated with lower levels of CRP in the     Framingham cohort, suggesting a possible role in the suppression of chronic inflammation that     is known to accompany vascular disease. The recent ECKO study suggested that vitamin K may     reduce falls and fractures; an intriguing question that follows on from this is whether this     could be due to beneficial effects on vascular health and postural hypotension, leading to     less dizziness and reduced falls.      This cross-sectional comparative study aims to find whether there is a difference in the     vitamin K status of patients with postural hypotension compared to those without postural     hypotension and whether differences in vitamin K status are associated with other markers of     vascular function in patients with and without postural hypotension. This could potentially     lead to new treatments for the condition for which there is currently little of proven     benefit.   "
59611|NCT02505269|"     Limited stage Hodgkin lymphoma is a highly curable disease, but standard treatment with ABVD     chemotherapy and radiation can lead to late risks of secondary cancers, lung injury, heart     injury, and others. This trial eliminates radiation therapy and reduces intensity of     chemotherapy by incorporating the highly active FDA-approved targeted therapy brentuximab     vedotin, an antibody-drug conjugate specifically against the lymphoma cells, combined with     the standard chemotherapy drugs Adriamycin and Dacarbazine (AD).   "
59612|NCT02505256|"     Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline     for the treatment of this disease. This study was launched to investigate into the problem     that which patients should be diagnosed as hyperplasia of mammary glands and which patients     should be treated.   "
60052|NCT02499536|"     The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding     on intraoperative lung ultrasound.   "
59615|NCT02505217|"     Treatment of patients who have had a heart attack with drugs that prevent formation of blood     clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as     heart attack, stroke, and death. Because new drugs have increased treatment options, the     development of tests that can guide treatment should improve treatment selection and further     reduce the risk of cardiovascular events as well as bleeding. This study is designed to     assess the value of new tests. It is a prospective study that will enroll patients who have     had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day     after their heart attack) and a second time 6 months later during an ambulatory clinical     visit. Investigators will perform biochemical tests on the blood that assess the likelihood     of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount     of blood poses no risk to the participant. Investigators will ask the participant whether     they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory     follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their     1 year of participation, investigators will review medical records and record information in     a manner that protects the identity of all participants. We hypothesize that the biochemical     test results will be similar at baseline and 6 month follow-up and that these biochemical     tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment     of participants will not be altered by their participation in this study.   "
59621|NCT02505139|"     A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies     such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome     prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Through the     observational prospective clinical trial, sensitivity, specificity, positive and negative     predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the value of     CTC in outcome prediction of mNPC patients will be uncovered.   "
59622|NCT02505126|"     The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol     consumption within the 24 weeks following the treatment in non-abstinent patients with     alcohol use disorders versus placebo.   "
59623|NCT02505113|"     To observe the etiology, diagnosis, management and prognosis of cavernous transformation of     portal vein.   "
59624|NCT02505100|"     The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy     complicated by preterm delivery in 5-10% of cases in developed countries. Psychological     stress that encompasses anxiety and anxiety resounding including sleep quality can be a work     of preacher and premature delivery.      Preterm birth before 37 has an impact on the survival and health of the newborn. It is the     leading cause of mortality and obstetric complications. It has a cost both for the newborn,     the term parturient health but also the financial cost by the management before delivery and     the consequences of a premature birth.      The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The     hospitalization and invasive procedures contribute to increasing stress. It therefore seems     necessary to seek to diversify and master reputable techniques for their effectiveness on     mastering stress and improving sleep quality as hypnosis and feel relaxing.      Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression.     It also reduces preoperative anxiety and during induction of anesthesia, as well as     behavioral disorders during the first postoperative week. Hypnosis can play an important role     in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug     therapy has prolonged pregnancy of patients followed in high risk pregnancy.      The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on     the anti-stress hormones and plays a role in reducing pain during childbirth.      Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in     case of MAP. The published data relate to a small number of patients and a low level of     evidence. Although there seems promising results, prospective studies are needed to conclude     its effectiveness in improving the stress, pain or other parameters.      Health workers trained in these techniques could observe during their production improved     sleep disorders, stress, better communication between doctor and patient. Moreover, these     treatments could induce an improvement in the overall care of patients, and therefore have an     impact on the continuation of pregnancy.      These findings are based on these hypothesis. There is a clinical gain the contribution of     hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This     would, among other improvements in sleep disorders and stress, decrease pain, and acting on     the extension of the term of pregnancy in women followed by these techniques and a decrease     in hospitalizations of newborns premature neonatology and neonatal intensive care units.   "
59625|NCT02505087|"     The objective of this study is to determine whether the administration of N-acetylcysteine     (NAC) improves oxidative stress. To determine this, the study will assess the impact of oral     treatment on the balance between reduced and oxidized form of glutathione in erythrocytes of     peripheral blood.   "
59635|NCT02504957|"     Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. The     aim of this study is to assess the feasibility and safety of this technique in the context of     a nationwide retrospective analysis.   "
59751|NCT02503449|"     The purpose of the study:1.Improve the understanding of the risk factors of pulmonary     cryptococcosis;2.Improve the awareness of pulmonary cryptococcosis clinical and imaging     manifestations;3.Grasp pulmonary cryptococcosis patients of clinical and imaging     manifestations in different conditions;4.Learn about antibacterial activity of antifungal     drugs for cryptococcosis in China.   "
59627|NCT02505061|"     The four purposes of this study are: 1) to examine the feasibility of providing children with     disabilities to explore the environment with a modified ride-on car; 2) to quantify whether     children with disabilities are able to have more social interactions with a ride-on car; 3)     to examine the progression of socialization during the intervention and follow-up phases to     determine which factors might influence the learning curve; 4) to compare the effectiveness     of using the modified toy cars through the hospital-based program and regular therapy program     after intervention and follow-up phases to determine the critical factors on increasing     independent mobility and socialization, including motivation, treatment executor, treatment     environment and play programs. It can provide guidelines for the future intervention.      Independent mobility is believed to be essential for perceptual-motor, cognition, language     and social skill development. It is important to increase the independent mobility in     children with disabilities and further enhance their development, especially motor and     socialization. Assistive and power mobility devices allow children with disabilities to move     independently within their environment and may increase the opportunities to explore and     interact with people and environment . However, issues to consider before prescribing an     assistive device include factors such as age, accessibly to community environments, cost,     social acceptance of the device and the adaptability of the device to growth. This study is     to use the customized, modified ride-on toy cars, to enhance the independent mobility,     exploration and socialization through low-cost, family-centered approach. It will also     improve family's understanding of children's capabilities, which improve their development.     Investigators will recruit 60 children with who are between 1 to 3 years old and diagnosed as     motor delay (>1.5 sd). They will be randomly assigned to one of the following two groups:     hospital-based program group and regular therapy group.      The whole study duration will be 18 weeks, including 9-week intervention and 9-week     follow-up; the total amount of treatment will be equal for two groups. The hospital-based     program will be administered by the therapist and include 120 minutes/per session, 2     sessions/per week. In addition, the research team will visit the hospital once/per week to     provide assessments. The regular therapy group will continue their regular therapy without     any additional car driving training. The research team will visit them once/per week for the     assessments. The assessments include behavior coding from the videotapes and the clinical     assessments. The findings of this study will help to understand the feasibility and     effectiveness of using the low-tech modified toy cars on advancing children's mobility and     socialization. They can be used in the clinics and are a low cost alternative or addition to     other mobility devices. They may provide a novel therapeutic tool to improve mobility,     socialization and development.   "
59628|NCT02505048|"     The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in     progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic     signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.   "
59629|NCT02505035|"     This is a large pragmatic, randomized controlled trial to test the real-world effectiveness     of inpatient palliative care consultative services in improving a number of patient- and     family-centered processes and outcomes of care among seriously ill hospitalized patients. The     investigators hypothesize that improved patient-centered outcomes can be achieved without     higher costs by simply changing the default option for inpatient palliative care consultation     for eligible patients from an opt-in to an opt-out system. To test this hypothesis the     investigators will conduct a clinical trial at 11 hospitals using the same electronic health     record within Ascension Health, the largest non-profit health system in the U.S.   "
59630|NCT02505022|"     During this study the investigators will 1) collect measures of social cognition and social     functioning in adolescents and young adults who are experiencing early symptoms of a major     mental disorder; and 2) evaluate the predictive value and utility of a new role functioning     assessment measure for individuals experiencing changes in their lives after an index episode     of mental illness. This will happen in the context of providing treatment-as-usual to     individuals who arrive seeking help with the early phases of mental illness.   "
59649|NCT02504775|"     This will be a monocentric, single blinded, randomized, single-dose, two-periods,     two-sequence, crossover bioequivalence study of two oral formulations in healthy participants     under fasting conditions.   "
59789|NCT02503046|"     Periodontitis and Rhematoid arthritis are chronic inflammatory diseases which share common     risk factors The purpose of this study is to determine if Pentraxin 3 and Porphyromonas     Gingivalis levels play an important role in the progression of both the diseases.   "
59631|NCT02505009|"     Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but     only about 30-40% remain sustained response 1-3 years after discontinued therapy. The     investigators will try to improve the sustained response rate by given a course of HBV     vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir     therapy.      Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are     suppressed during entecavir or tenofovir therapy.      Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30     months will be invited to this study. The case group will receive 5 Engerix-B injections     during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated group:     75 cases will be enrolled to receive Engerix-B injection and compared with histological     non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients will be     randomized into case (vaccine) and control group according to age, gender, pretreatment HBV     DNA level.      Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir     therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir or     tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th month     [30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be     discontinued after completed therapy.      Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative     HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy.      Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL     after discontinued nucleos(t)ide analogues therapy will be considered to have sustained     response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously     without further therapy will be defined as delayed response. Patients with persistent HBV DNA     greater than 1*100000 cps/mL will be considered to have non-sustained response.      Study duration: The enrollment will be completed in one year and keep on observation for     additional 2 years.      Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may     decrease the HBV relapse rate at 1 and 2 year after completed therapy.   "
59632|NCT02504996|"     Siatalgia is one of the main symptoms related to emergency department presentations. Patients     with sciatalgia are seeking for immediate pain relief and little known regarding the pain     management of these patients in emergency department. This study aim to trial the effect of     intravenous paracetamol and morphine in patients presented with sciatalgia to emergency     department.   "
59633|NCT02504983|"     Transcatheter arterial chemoembolization (TACE) + sorafenib therapy has been demonstrated to     exert a beneficial effective on time-to-tumor-progression (TTP) in patients with unresectable     hepatocellular carcinoma (HCC) in some studies. However, the beneficial effect varies among     studies conducted in different areas of the world. The objectives of this study are (1) to     understand whether GALNT14 TT genotype patients respond better than do GALNT14 non-TT     genotype patients when treated by TACE; and (2) to understand whether GALNT14 non-TT genotype     patients can benefit from TACE plus sorafenib (Nexavar) combination therapy. Patients     enrolled will be stratified by GALNT14 genotyping. The GALNT14 non-TT patients were then     randomized into two subgroups to evaluate the safety, tolerability and efficacy of TACE plus     sorafenib therapy.      The primary endpoint of this study is the efficacy of TACE with or without sorafenib     combination therapy evaluated by complete remission (CR).      The secondary endpoints are:        1. Time to partial or complete response (PR + CR).        2. Time-to-tumor-progression (TTP) and the progression free survival (PFS).        3. Overall survival (OS).        4. Safety and tolerability of TACE plus sorafenib therapy.   "
59634|NCT02504970|"     The Anesthesia Quality Institute (AQI) is home to the National Anesthesia Clinical Outcomes     Registry (NACOR), a data warehouse that has been designated as a Qualified Clinical Data     Registry (QCDR) by the Centers for Medicare and Medicaid Services (CMS) for Physician Quality     Reporting System (PQRS) reporting. With 20 million cases and growing, Anesthesia Quality     Institute's clinical data provides an evidence-based rational that informs treatment choices     and helps control treatment costs.      National Anesthesia Clinical Outcomes Registry is intended for all anesthesia providers     caring for patients. The registry provides participating providers with:      Custom continuous performance monitors Performance gap analysis and patient outlier     identification Access to improvement interventions to close performance gaps including     patient care management tools, targeted education, resources and other evidence based     interventions Registry and peer-to-peer benchmarks   "
59636|NCT02504944|"     The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye     drops in treating preterm newborns with a precocious stage of retinopathy of prematurity     (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive     propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no     more than 90 days.      Propranolol concentrations will be measured on dried blood spots at the steady state (10th     day). Cardiovascular and respiratory parameters will be continuously monitored. Blood     samplings checking metabolic, renal and liver functions will be performed periodically, as     well as cardiac function, in order to verify the treatment safety. Serial ophthalmological     evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and     the possible complications.   "
59637|NCT02504931|"     The investigators propose to conduct a clinical trial to evaluate sertraline treatment     efficacy in a large sample of military veterans with a dual diagnosis of PTSD and Alcohol Use     Disorder who are receiving Cognitive and Behavioral Therapy as part of the VA-system's new     dual diagnosis program. The study is designed as an efficacy trial of sertraline used as an     adjunct to Cognitive Behavioral Therapy (CBT) in the treatment of PTSD/Alcohol dual     diagnosis. There are two outcomes of interest, namely PTSD symptom improvement and also     decreased alcohol consumption. The investigators are interested to know whether or not     sertraline is superior to placebo in improving the symptoms of either one or both of these     two disorders. Even though sertraline is a treatment of choice for PTSD, the investigators     expect that the comorbid condition of alcohol dependence will complicate the treatment of     PTSD and that the clustered subgroups will show differential treatment response with     sertraline. The primary objective of the present study is to identify subgroups of alcohol     dependent persons with PTSD who will either benefit or not benefit from treatment with     SSRI's. The proposed study will enroll veterans with PTSD and dually-diagnosed alcohol     dependence in a 12-week treatment providing sertraline vs. placebo medication as an adjunct     to manualized CBT and will specifically test the hypothesis that subtypes of alcohol     dependence can be used to predict which patients respond well and which subgroup responds     poorly to SSRI treatment.   "
59650|NCT02504762|"     To evaluate whether an HCR strategy is more or less effective than conventional coronary     artery bypass grafting (cCABG), in diabetic patients with multivessel CAD involving the left     anterior descending artery (LAD), who do not present in the context of acute ST-elevation     myocardial infarction (STEMI).   "
59651|NCT02504749|"     This study aims to compare the time to regain intestinal motility after general anesthesia     versus spinal anesthesia for cesarean section.      A double blinded randomized controlled trial was conducted at the Department of Obstetrics     and Gynecology, Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo,     Egypt, between July 20 and November 20, 2015. In the study hospital, the total number of     deliveries in 2012 was 15 167, 6244 (41.2%) of which were by cesarean; in 2013, the total     number of deliveries was 16 057, 5200 (32.4%) of which were by cesarean.   "
59638|NCT02504918|"     Background:      - The disease malaria can cause very serious health problems. Researchers want to see if     malaria affects the way T cells and vaccines work in the body. If it does, they may need to     give malaria treatments before vaccines. They want to check the T cells in children who do or     do not get antimalarial treatment.      Objectives:      - To study the effect of blood stage malaria on T cell suppression and vaccine responses. To     describe markers of T cell suppression in children who do or do not receive antimalarial     treatment.      Eligibility:      - Children ages 12 59 months living near Ouelessebougou in Mali. They must have no serious     illness.      Design:        -  Participants will be screened with medical history and physical exam.        -  Some participants will get a course of antimalarial tablets. Some will not. This will be          decided at random.        -  Participants will have monthly visits for up to a year. They will have blood tests at          each visit.   "
59639|NCT02504905|"     Background:      - People with dystonia have muscle contractions they can t control. These cause slow,     repeated motions or abnormal postures. People with dystonia have abnormalities in certain     parts of the brain. Researchers want to study the activity of two different brain areas in     people with writer s cramp and cervical dystonia.      Objective:      - To compare brain activity in people with dystonia to that in healthy people.      Eligibility:        -  Right-handed people ages of 18 60 with cervical dystonia or writer s cramp.        -  Healthy volunteers the same ages.      Design:        -  Participants will be screened with a physical exam. They will answer questions about          being right- or left-handed.        -  At study visit 1, participants will:<TAB>        -  Have a neurological exam.        -  Answer questions about how their disease impacts their daily activities.        -  Have a structural magnetic resonance imaging (MRI) scan. Participants will lie on a          table that can slide <TAB>in and out of a metal cylinder. This is surrounded by a strong          magnetic field.        -  Do 2 simple computer tasks.        -  At study visit 2:        -  Participants will have transcranial magnetic stimulations (TMS) at 2 places on the head.          Two wire <TAB>coils will be held on the scalp. A brief electrical current creates a          magnetic pulse that affects brain <TAB>activity. Muscles of the face, arm, or leg might          twitch. Participants may have to tense certain muscles or do simple tasks during TMS.          They may be asked to rate any discomfort caused by TMS.        -  Muscle activity in the right hand will be recorded by electrodes stuck to the skin of          that hand.   "
59640|NCT02504892|"     Background:      - Research has shown that the drug everolimus can stop cancer cells from growing. It is     approved for people with advanced kidney cancer. Researchers want to see if it also helps     people with two other types of kidney cancer.      Objective:      - To see if everolimus is safe and effective in people with Birt-Hogg-Dube Syndrome     (BHD)-associated kidney cancer or sporadic (nonfamilial) chromophobe renal cancer.      Eligibility:      - People ages 18 and over with BHD-associated kidney cancer or advanced sporadic chromophobe     renal cancer.      Design:        -  Participants will be screened with:        -  Medical history, physical exam, and blood and urine tests.        -  Computed tomography (CT) scan or magnetic resonance imaging (MRI) scan. They will lie in          a machine that takes pictures of their chest/abdomen/pelvis.        -  They may also be screened with:        -  Another scan, of the brain or neck.        -  Bone scan.        -  Positron emission tomography scan with fludeoxyglucose (FDG-PET).        -  Heart and lung tests.        -  Tests for hepatitis.        -  Participants will take a tablet once a day by mouth for up to a year. They will keep a          diary of when they take the tablet and any symptoms.        -  During the study, participants will have physical exams and urine and blood tests. They          will have scans of the chest/abdomen/pelvis. They may have FDG-PET and bone scans.        -  Participants will have tests for hepatitis and may have a tumor sample taken.        -  Participants will have a follow-up visit 4 5 weeks finishing taking the drug. They will          have a physical exam and blood tests. They may have scans and/or hepatitis tests.        -  Participants will be called about every 3 6 months after the study ends to see how they          are doing   "
59662|NCT02504606|"     This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan     with Amosartan, which was available commercially after single oral dose in healthy male     subjects.   "
59641|NCT02504879|"     Background:      - The rare disease melorheostosis causes bones to thicken. This may lead to pain, and can     affect bones, joints, and muscles. Researchers want to learn more about the disease and how     it progresses.      Objective:      -To see what happens to people with melorheostosis over time and understand the causes of the     disease.      Eligibility:        -  People 18 and over with melorheostosis.        -  Their unaffected relatives.      Design:        -  All participants will have a medical history and physical exam.        -  Participants who are relatives will give samples of blood or cheek cells.        -  Other participants will be in the study for about 1 week.        -  They will have blood and urine collected.        -  Strength, walking, and range of motion will be measured.        -  Participants may also have        -  X-rays and scans.        -  A pain and neurological evaluation.        -  Their skin evaluated by a dermatologist.        -  A small sample of bone taken.        -  Nerve conduction studies. Small electrodes with to wires will be put on the skin. A          metal probe will give a small electrical shock.        -  Electromyography. A thin needle will be placed into the muscles.        -  An ultrasound, which uses sound waves to examine the muscles and nerves. An ultrasound          probe will be placed over the skin.        -  A bone scan. They will get a small amount of radioactive fluid through a needle in an          arm vein. This fluid travels to the bones. The bones will be photographed in a machine.        -  Bone Densitometry, a low-level x-ray.        -  Photographs taken.        -  A small circle of skin removed with a surgical instrument.        -  Questionnaires about their quality of life.        -  Participants will be asked to return about every 2 years. At these visits, participants          may have blood and urine tests and x-rays.   "
59652|NCT02504736|"     To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South     Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains     above target despite optimal statin use.   "
59653|NCT02504723|"     Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal     bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective     β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is     not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to     gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.   "
59654|NCT02504710|"     This study will try to analyze the effect of the real-time kinematic feedback (KRTF) to learn     manual therapy on peripherical joints comparing the results with the traditional teaching     method.   "
59790|NCT02503033|"     The purpose of this study is to evaluate the safety and tolerability of HMPL-523 administered     to patients with relapsed or refractory Hematologic Malignancies      To determine the maximum tolerated dosage/recommended phase 2 dosage and characterize the     dose limited toxicities associated with HMPL-523 when administered to patients with relapsed     or refractory Hematologic Malignancies   "
59642|NCT02504866|"     Background:      - Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking     and emotions. Exercise can improve these things in people with other brain damage.     Researchers want to look at the effect of exercise on these things in people with TBI.      Objectives:      - To study how head injuries affect the brain. To study if exercise can help some symptoms in     people with TBI. These include problems thinking, balancing, and moving, and depression or     anxiety.      Eligibility:        -  People age between 18 and 79 :        -  Had a non-penetrating TBI at least 12 months ago.        -  Are physically inactive, but can stand and walk without help.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests. They may have a balance test.        -  Participants will be assigned to a high-intensity or a lower-intensity exercise program.        -  The study is 6 months long. There will be 3 months with exercise on an elliptical          machine and 3 months without exercise.        -  Participants will exercise for 30 minutes on an elliptical machine, 3 days per week for          3 months.        -  Participants will also have 3 outpatient testing visits lasting approximately 8 hours,          once every 3 months. This visit will include:        -  Blood tests        -  Tests for memory, attention, and thinking        -  Tests of walking and balance        -  Questionnaires        -  An MRI: they will lie in a machine that takes pictures of their brain, while breathing          regular air and air with more carbon dioxide        -  Test of physical fitness.   "
59643|NCT02504853|"     Background:      - About 15 million Americans have a food allergy. Because there are no cures or effective     prevention or treatment for food allergies, researchers want to learn more about them.      Objective:      - To learn more about the causes and effects of food allergy and related conditions.      Eligibility:        -  People ages 2 99 who have food allergy and/or a related genetic or other condition        -  Their relatives        -  Healthy relatives and volunteers      Design:        -  Participants will have at least 3 visits over 1 2 years, and then once a year for up to          12 years. Each may last a day or longer.        -  Participants will be screened with medical history, physical exam, and questionnaires.        -  Participants may have the following:        -  Blood tests        -  Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is          scratched under each drop.        -  Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and          returned through a needle in the other arm.        -  X-rays        -  Esophageal string test: One end of a string is taped to the cheek and the other end is          packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in          for at least 1 hour.        -  EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.        -  Tiny biopsies of skin        -  Photographs of the body        -  Collection of cells through:        -  Swab of nose, inside of cheek, or skin        -  Gentle skin scrape        -  Tape stripping: piece of tape is put on the skin and pulled off.   "
59644|NCT02504840|"     Background:      - Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor     neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI     pictures are taken. They also want to learn more about using newer MRIs with stronger magnets     to get better pictures than standard MRIs provide.      Objectives:      - To collect data that will help researchers better understand MS and related diseases.      Eligibility:        -  Adults 18 and older with MS or MRI findings that appear similar to MS, or with other          neurological diseases that may look or act like MS.        -  Healthy adult volunteers.      Design:        -  Participants will be screened with a review of their medical records.        -  Participants will have a baseline visit. It will include a physical exam, medical          history, and neurological exam. They may have blood tests.        -  The study will last indefinitely.        -  Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle          will be used to guide a thin plastic tube into an arm vein.        -  Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a          needle inserted between back bones will remove fluid.        -  Participants may give saliva samples and have an eye exam.        -  Participants may have evoked potential tests. These measure how the nervous system          responds to different types of stimulation. Participants may sit in front of a TV and          watch pictures on the screen. Or they may wear earphones that make a clicking noise or          static. Or they may get a small electrical shock that may tingle and cause a hand or          foot twitch.        -  Participants may have tests of strength, spasticity, sensations, balance, and/or          walking.   "
59645|NCT02504827|"     The purpose of this research study is to characterize the pharmacokinetics of intravenous     ceftazidime/avibactam in patients with Cystic Fibrosis.   "
59646|NCT02504814|"     The study explores the changes in pressure, volume and in hypercapnia in patients with COPD.     The investigators will use different application forms.   "
59647|NCT02504801|"     To test the hypothesis that nebulized Pulmicort Respules could reduce post operation     pulmonary complication incidence in primary lung cancer patients with COPD. Compare     post-operation pulmonary complication incidence in two treatment arms among primary lung     cancer patients with COPD required single lobectomy from 3days before operation to 7 days     after operation.   "
59648|NCT02504788|"     Whole brain radiotherapy (WBRT) has long been a practical and effective therapeutic modality     for various settings of management in radiation oncology. For example, the indications for     WBRT should include brain metastasis or metastases, the setting of prophylactic cranial     irradiation (PCI) used mainly for patients with limited-stage small cell lung cancer, and     even some patients with extensive-stage small cell lung cancer. The rationales for WBRT are     essentially based on that it can target both microscopic and gross intracranial disease.      In addition to providing rapid alleviation of neurologic symptoms and enhanced intracranial     disease control, WBRT might also prolong the time to develop neurocognitive function (NCF)     decline. However, paradoxically NCF decline can also occur due to a sequel of WBRT. In terms     of the time course of WBRT-induced NCF decline, it might vary considerably according to the     specific domains which are selected to be measured. Early neurocognitive decline occurs     within the first 1 - 4 months after WBRT for brain metastases. The domains of early     neurocognitive decline principally involve verbal and short-term memory recall.      Since several decades ago, it has been understood that hippocampus plays an essential role in     memory function. Not little evidence supports that radiation-induced damage to hippocampus     should be strongly associated with NCF impairment. Furthermore, several studies have shown     that isodose distribution in hippocampus is closely related to neurocognitive function in     patients with benign or low-grade brain tumors. As a consequence, it is hypothesized that     conformal hippocampal sparing during the course of WBRT (HS-WBRT) might provide significant     preservation in terms of cognitive function.      This prospective cohort study aims to explore and evaluate the impact of the delivery of     HS-WBRT on the pattern of NCF change and the extent of NCF decline in patients receiving     prophylactic or therapeutic WBRT. As compared with previous related and relevant studies, it     will also be investigated whether neurocognitive functional preservation can be achieved via     the integration of hippocampal sparing with the course of WBRT.   "
59655|NCT02504697|"     The goal of this project is to improve lung cancer screening in high-risk individuals by     identifying biomarkers of preclinical disease and disease risk that are measured in minimally     invasive and non-invasive biospecimens. Existing biomarkers for lung cancer diagnosis as well     as new biomarkers discovered specifically in this clinical setting will be examined.     Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer     prior to the appearance of concerning symptoms could increase the utility of lung cancer     surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving     these goals would improve the detection and treatment of early stage and incipient lung     cancer, while restricting the risk of these procedures to those individuals who currently     exhibit the early molecular warning signs of impending disease.   "
59656|NCT02504684|"     Objective: Compare venous occlusion rates at a one-year follow-up comparing 1920-nm versus     1470-nm laser treatment. Design: Non-randomized prospective study. Methods: Adult patients     with varicose veins associated with great saphenous reflux were included. Procedures were     performed between February and April of 2013. The 1470-nm laser ablation was performed in     continuous mode, power being set between 8 and 10 W, while for the 1920-nm it was set between     5 and 6 W. Checking for vein closure was performed during the thermal ablation procedure,     LEED (linear endovenous energy density) being calculated after the procedure. Follow-up data     were collected at the 7-day, 30-day, 3-month, 6-month and 1-year visits, and involved     clinical and ultrasound evaluation, measurement of occlusion extent.   "
59657|NCT02504671|"     This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group,     placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in     combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid     arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into     the study, following a screening period of up to four weeks. The total treatment period is up     to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be     randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in     combination with MTX (at a weekly dose between 15-25 milligram [mg]), previously received for     at least 12 weeks, with a stable and tolerated dose and route of administration for >=4     weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that     do not achieve adequate disease improvement.   "
59658|NCT02504658|"     This 4-week pilot study is designed to test the feasibility, adherence, and effectiveness of     a cell phone text message program for lifestyle goal setting among adolescents with type 1 or     type 2 diabetes. The study entails a small-scale randomized controlled trial with pre-post     test of a mobile text message program.   "
59659|NCT02504645|"     This current Phase 3 study will evaluate the efficacy and safety of administration of     subcutaneous (sc) IPP-201101 in patients with active SLE.   "
59660|NCT02504632|"     Study of platelet activation by severe aortic stenosis and its correction by Transcatheter     Aortic Valve Implantation (TAVI)   "
59661|NCT02504619|"     CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells     composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to     evaluate the safety and efficacy of CordIn™.   "
59663|NCT02504593|"     The investigators propose to implement a new mobile interface that automatically reads and     troubleshoots malaria rapid diagnostic test (RDT) cassettes. This device, called a Deki     reader (DR), will allow the investigators to establish an extensive quality assurance program     of malaria diagnosis performed by trained community health volunteers (CHVs). The study will     lease 10 DRs and rotate them amongst 200 CHVs performing community-based malaria diagnosis     through rapid diagnostic testing. The study setting is Bungoma East subcounty and Kiminini     subcounty in Kenya. The overall goal is to measure and improve the quality of malaria     diagnosis by CHVs using malaria RDTs. The investigators aim for every CHW to exceed 90%     sensitivity and specificity and zero operator errors within six months. There are no     appreciable risks to the CHV associated with evaluation by the DR device. The investigators'     analysis will focus on descriptive statistics of RDT use and accuracy amongst all     participating CHVs.   "
59664|NCT02504580|"     A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and     Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical     Application Following Unilateral Open Inguinal Herniorrhaphy   "
59665|NCT02504567|"     This protocol aims at assessing the efficacy of performing catheter ablation for atrial     fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF)     catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3     months after the procedure will be performed in both groups. MRI analysis will detect     ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare     the number of gaps in the laser catheter and the RF group. The secondary endpoint of the     study is recurrence of AF after 12 months. The target population of the study is patients     with paroxysmal or persistent AF undergoing AF ablation.   "
59666|NCT02504554|"     This is an open-label clinical trial to investigate a combination therapy for treating     gastrointestinal problems in children with autism spectrum disorders.      The combination therapy includes beneficial bacteria.   "
59667|NCT02504541|"     Evaluation of safety of a concentration controlled testosterone enanthate QuickShot     Testosterone regimen administered subcutaneously once each week to adult males with     hypogonadism.   "
59668|NCT02504528|"     The purpose of this study is to establish the methodology of bronchial provocation tests with     house dust mites in China, and to evaluate its safety and effects on upper and lower airways     inflammation.   "
59687|NCT02504281|"     To determine whether there is higher incidence of skewed X chromosome inactivation(SXCI) in     the recurrent miscarriage(RM) population compared with normal population, and screen the     possible genetic sites that may lead to SXCI and RM by genome microarray analysis of the RM     patients with SXCI and normal females with SXCI.   "
59688|NCT02504268|"     The purpose of this study is to determine if abatacept is effective in the treatment of early     rheumatoid arthritis.   "
59804|NCT02502851|"     The primary objective of this study is to evaluate the success of lesion preparation with     either rotational atherectomy or cutting/scoring balloons as well as the long term effects of     a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with     complex calcified coronary lesions.   "
59669|NCT02504515|"     Patients will be randomly assigned to two separate groups. Both patient groups will be     evaluated using the WHOQOL-BREF questionaire. Evaluations will be carried out just before the     study begins and at intervals of six months during a period of one year for a total of three     evaluations. Group one will be made up of patients who will begin homeopathy or acupuncture     or anthroposophic medicine treatment and patients from group two will start homeopathy or     acupuncture or anthroposophic medicine six months after the beginning of the study. Each one     of these three research branches will be done independently (Homeopathy versus control;     Acupuncture versus control; Anthroposophic Medicine versus control). Conventional medical     treatment will be available for all patients in both groups. A data sheet will be filled out     on each patient with data as to age, education level, marital status and the patient's own     perception of their health status. During the interviews the interviewer will have no     influence whatsoever over the respondents' answers. Integrative/complementary or traditional     medicine doctors do not participate in the research and will not be informed about which     patients are participating in this project, and as such the research will be blinded for     these doctors. Minitab software, version 16, was used for sample calculation through the     module Power and Sample Size. Sample calculation option for paired t-tests before and after     intervention demonstrated the need to randomize 906 patients: 450 patients for homeopathy     branch (225 patients in the homeopathy group and 225 patients in the control group), 228     patients for acupuncture branch (114 patients in the acupuncture group and 114 patients in     the control group), and 228 patients for anthroposophic medicine branch (114 patients in the     anthroposophic medicine group and 114 patients in the control group).   "
59670|NCT02504502|"     Current lab reports are designed to communicate results from the laboratory to the provider;     they are not designed to be accessible to patients. The investigators believe that a new type     of genomic test report, tailored for patient- as well as provider-use, will enable patients     to have access to information they can understand allowing them to be more involved in the     management of their disorders, better navigate the health care system, and make more informed     decisions about their health and health care in conjunction with their providers. This     approach has the potential to improve outcomes from both the patient and provider     perspectives.      The investigators propose to study the research question, Can a genomic laboratory report     tailored for both providers and families of patients improve interpretation of complex     results and facilitate recommended care by enhancing communication and shared decision     making?   "
59671|NCT02504489|"     The primary purpose of the study is to compare the overall survival of NSCLC patients     receiving second- or third-line chemotherapy with docetaxel + plinabulin (DP Arm) to patients     treated with docetaxel + placebo (D Arm) for advanced or metastatic disease.      Secondary purposes of the study are:        1. To compare the neutropenia (frequency, severity and clinical sequelae), duration of          response, quality of life, response rate and progression free survival in patients with          NSCLC treated with DP to patients treated with D as second- or third-line chemotherapy          for advanced or metastatic disease; and        2. To compare the safety and adverse event profiles of DP to D respectively, as well as          dose delays, dose modifications, and/or dose discontinuation of docetaxel due to safety          concerns in the two treatment arms.        3. To evaluate population pharmacokinetics in patients enrolled in China and western          countries (US and Australia).   "
59672|NCT02504476|"     The purpose of this study is to find out the time it takes to absorb, distribute, breakdown     and remove the drug from the body in healthy participants and subjects with schizophrenia and     whether it causes any side effects.   "
59673|NCT02504463|"     This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male     volunteers.   "
59674|NCT02504450|"     To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol)     in order to evaluate outcomes.   "
59675|NCT02504437|"     The purpose of the present study is to evaluate the efficacy of the preconditioned autologous     bone marrow mesenchymal stem cells for patients with ischemic heart diseases.   "
59676|NCT02504424|"     This study is designed to allow existing investigators continued access to the AeroForm     Tissue Expander to treat patients while AirXpanders completes a marketing application and     during the review process by FDA.   "
59677|NCT02504411|"     The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with     standard colonoscopy (SC) in detecting adenomas in a randomized fashion.   "
65821|NCT02424149|"     In this prospective, randomized trial subjects will be randomized to receive phenazopyridine     or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm     ureteral patency intraoperatively.   "
59679|NCT02504385|"     The subjet of this study is to explore the effect of using virtual reality environment at the     clinic and at home (using Timocco) on the motor and participation abilities of children with     DCD (Developmental Coordination Disorder).      The study will examine the efficacy of using virtual reality gaming environment (Timocco) for     treating children with DCD and the use of remote therapy, by shifting the focus of therapy     from the clinic to the home environment, using the remote control system of Timocco for home     practice.   "
59681|NCT02504359|"     This phase Ib trial studies the side effects of combination chemotherapy and donor stem cell     transplant followed by ixazomib citrate maintenance therapy in treating patients with     multiple myeloma that has returned after a period of improvement and is likely to recur (come     back), or spread. Giving chemotherapy before a donor peripheral blood stem cell transplant     helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem     cells) and cancer cells. When the healthy stem cells from a donor are infused into the     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood     cells, and platelets. Giving ixazomib citrate after the transplant may improve the overall     treatment outcome without causing additional toxicities.   "
59682|NCT02504346|"     Phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once     daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or     metastatic NSCLC, who have progressed following treatment with an approved epidermal growth     factor tyrosine kinase inhibitor agent.   "
59683|NCT02504333|"     The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane)     and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously     untreated, metastatic pancreatic adenocarcinoma   "
59684|NCT02504320|"     This study will assess the relative bioavailability, safety and tolerability following     administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.   "
59685|NCT02504307|"     Prospective, single center, randomized and non-inferiority study, to include up to 60     patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and     12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.   "
59686|NCT02504294|"     A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira     Epoetin and Standard of Care Epogen.   "
59689|NCT02504255|"     Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable     remission. the probability of recurrence of CD in a patient in remission is even stronger if     it pre-exists endoscopic lesions of the intestinal mucosa.      The mucosal healing exploration needs the realization of an ileo-colonoscopy under general     anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its     too frequent repetition. we do not currently have noninvasive and reliable markers able to     predict the occurrence of thrust of CD and allow the introduction of a more suitable     treatment.      Indeed, relapse prevention is the best way to avoid complications and formation of lesions     that lead to the irreversible medical treatment failure and surgery.      Since during the CD, it is the immunological changes that lead to inflammation and lesions,     we make the assumption that the ability of certain markers immunological to predict a relapse     of CD is higher than that of other in particular inflammatory markers.      This work should help to identify the profile of patients with CD in remission but at high     risk of recurrence. It will specify i) the potential new markers immunological, from the     pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest     of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally,     the stress and the management of stressful events in the occurrence of a relapse.      This work also will specify the evolution of different markers at the moment of thrust   "
59690|NCT02504242|"     A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate     the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody     Fusion.   "
59691|NCT02504229|"     This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with     cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil     Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or     metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and     oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin     adjuvant chemotherapy served as controls.   "
59692|NCT02504216|"     The purpose of study is to test whether rivaroxaban added to standard of care treatment, when     compared to placebo, has the potential to reduce the incidence of the clinical events related     to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs     (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s)     to improve the blood flow of their legs.   "
59693|NCT02504203|"     The purpose of this study is to determine whether BCG vaccination shortly after birth can     reduce early infant mortality in a rural setting.   "
59753|NCT02503423|"     This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660,     determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended     dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target     engagement data, in subjects with advanced solid tumors or lymphoma for whom standard     life-prolonging measures are not available.   "
60076|NCT02499224|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     maximum tolerated dose (MTD) of YYB101, HGF-neutralizing humanized Mab, in advanced solid     tumors patients who are refractory to standard therapy.   "
59694|NCT02504190|"     Lymphoma is a malignant blood disease sensitive to chemotherapy. In case of relapse after     first-line treatment, high-dose chemotherapy conditioning followed by autologous     hematopoietic stem cell transplantation (auto-HSCT) improves patient survival and reduces the     risk of relapse. Auto-HSCT may also be indicated in the first line in case of aggressive     lymphoma at high risk of relapse. BEAM (Carmustine, Etoposide, Aracytine and Melphalan) is     the more frequently used high-dose conditioning regimen. Nevertheless, Carmustine is no     longer available in Europe.      The investigators have therefore chosen to replace Carmustine by Thiotepa and use the TEAM     regimen as the new conditioning. Indeed, Thiotepa is approved by french national agency for     the security of drugs (ANSM) for use as part of auto-HSCT conditioning regimen. The results     of TEAM regimen in terms of efficacy and toxicity appear similar to those of BEAM. However,     no study have been performed prospectively. Only small series and case reports have been     reported.      If the study confirms the results of retrospective studies, conditioning by TEAM could become     a new standard in auto-HSCT for the treatment of lymphoma.      This study is non-interventional, prospective with 3 centers.      All included patients will receive, according to standard practice and drug label in France,     the following diagram:        1. Conditioning:             -  Thiotepa 8 mg / kg to J-6             -  Etoposide 100 mg / m² / 12 h for 4 days (J-5 to D-2)             -  Aracytine 200 mg / m² / 12 h for 4 days (J-5 to D-2)             -  Melphalan 140 mg / m² on day-1        2. Transfusion graft: the day D0 with autologous peripheral stem cell transplant        3. Care supports: Patients will be treated according to the usual procedures of centers          participating in the study at the discretion of the investigator.        4. Follow-up of patients will not be changed by the study.      The main objective of the study is to evaluate the progression-free survival (PFS) of     lymphoma patients treated with autologous stem cells after conditioning by TEAM      Secondary objectives are:        -  To evaluate overall survival;        -  To assess the response to treatment;        -  to evaluate the incidence of relapse;        -  to assess the toxic transplant related mortality;        -  to study transplant-related morbidity (infections, nutritional and gastrointestinal          toxicity, immune reconstitution).   "
59695|NCT02504177|"     This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial     fibrillation ablation. The investigators will compare the bleeding complications were     classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission     and increased in the length of hospital stay during the 30-day post-radiofrequency catheter     ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients     who stop NOAC in the morning of the procedure.   "
59696|NCT02504164|"     Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and     minimizing patient movement is of key importance for successful outcome. Propofol has widely     replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the     quality of procedure in our past study. However, despite higher satisfaction scores of the     endoscopists and faster post-procedural recovery, patient satisfaction scores were found to     be higher in patients that received midazolam and meperidine instead of propofol and     remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather     than the quality of sedation itself. Investigator hypothesized that by premedicating the     patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl,     patient satisfaction would be enhanced without affecting endoscopic performance.   "
59709|NCT02503995|"     This study aimed to investigate whether there are measurable differences in CHANS function in     pregnant women who receive only standard antenatal care compared with those who additionally     undertake a programme of regular physical exercise.   "
59806|NCT02502825|"     The purpose of this study is to compare the diagnostic validity (sensitivity and specificity)     and evaluate the safety of 2-min Tidal Breathing methacholine bronchial provocation tests     with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.   "
59697|NCT02504151|"     Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations     in cannabis extracts. CBD has been shown to produce central effects including hypnotic,     anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that     treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the     Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a     reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1)     Greater improvement in functioning as measured on the Patient Assessment of Own Functioning     Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design,     subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1)     followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2)     under double-blind conditions. The 2 study periods will be separated by a washout of at least     2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or     placebo) for a period of 4 weeks.   "
59698|NCT02504138|"     Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and     long-term hepatic dysfunction after liver transplantation. Protecting the liver against I/R     injury and maintaining hepatic function during transplant surgery is therefore very important     in order to improve post-operative outcome. This purpose of this study is to investigate     whether propofol anesthesia done in both liver donors and recipients during living-donor     liver transplantation is effective in reducing liver I/R injury via its antioxidant and     antiinflammatory properties and improve post-transplant outcome compared to desflurane     anesthesia.   "
59699|NCT02504125|"     A randomized, double-blind, single-center and controlled study comparing the efficacy and     safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous     bilateral total knee arthroplasty.   "
59700|NCT02504112|"     The objective of the observational study is to assess the positioning of customized guides     designed from patients X-Rays (Zimmer® X-Ray PSI Knee) using optical navigation in primary     total knee arthroplasty.   "
59701|NCT02504099|"     The purpose of this study is to evaluate the safety and efficacy of     ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered     with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or     genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with     compensated cirrhosis.   "
59702|NCT02504086|"     The purpose of this study is to evaluate the effect of online support for diabetes     self-management for patients with Type II diabetes in the Vancouver region. Patients will be     invited to receive 8 online video consultations (total 2.5 hours) with certified healthcare     providers (video calls in a secure Website). Participants will also have access to the use of     an online personal health record -- a place to store healthcare information for the patient     and healthcare provider to view. Patients' ability to care for their diabetes will be     measured at the beginning and the end of the study. Additional measures include glycaemic     control, BMI, waist circumference, diabetes self-efficacy, computer and health literacy,     patient satisfaction with care and perceived ease of use and perceived usefulness of the     technology.   "
59703|NCT02504073|"     The goal of this study is to find out what clinical reasoning process physiotherapists     undergo when observing hemiplegic patients gait.   "
59754|NCT02503410|"     This study aims to compare the outcomes of a traditional, exercise-based rehabilitation     intervention for chronic low back pain with the outcomes achieved by combining a traditional     intervention with adjunct therapy delivered using an interactive gaming-based system for     home-based therapy. 50 subjects with non-specific cLBP will be recruited in the study.     Following baseline measures, study volunteers will be randomized to either the Usual Care     alone group or to the Interactive Home-Based System group. In each group, an endpoint     assessment session will be conducted at approximately 4 and 8 weeks post baseline measures.   "
59704|NCT02504060|"     This study is a randomized double-blind placebo-controlled clinical trail to evaluate the     clinical efficacy and safety of 1.1 chemical drugs N-acetyl-D-glucosamine on Chinese IBS-D     patients coming from thirty- six centers in Chinese. 720 IBS-D patients (360 for treatment     group, 360 for placebo group) in this research are accord with the Rome III diagnostic     criteria, screening/import period pain intensity scores of the NRS(numerical rating scale)     week mean value are 3.0 plus and the days which at least more than one time a stool type are     6 or 7 type over 2 days/week. Test cycle includes screening/import period (2 weeks), open     treatment period (12 weeks), follow-up period (2 weeks). The main outcome measures are pain     intensity (NRS score 11 point scale) and stool type ( Bristol type), and secondary endpoints     included overall symptoms sensory scores, defecation frequency, abdominal distension,     defecation urgency and quality of life parameters (IBS-QOL scale).   "
59705|NCT02504047|"     The administration of high-dose chemotherapy followed by the infusion of blood or bone marrow     stem cells (stem cell transplantation) from a matched donor has become standard treatment for     patients with high-risk or relapsed hematological cancers. Currently, donors are found for     approximately 80% of people who require such treatment, although the chance of finding a     donor is much lower in some ethnic communities. In the current study the investigators will     offer patients requiring transplantation, but for whom well matched donors cannot be     identified either from within the family or on the donor registry, a transplant from a     half-matched (haploidentical) family member. A myeloablative conditioning regimen and     un-manipulated peripheral blood stem cells will be used. Post-transplant cyclophosphamide,     tacrolimus and mycophenolate mofetil will be used to prevent graft versus host disease     (GVHD). The primary outcome measure will be 6 month survival free from graft failure, relapse     and grade 3-4 acute GVHD. Other outcomes of interest will include the frequency of     Cytomegalovirus (CMV) or Epstein-Barr Virus (EBV) requiring treatment, overall survival and     progression-free survival.   "
59706|NCT02504034|"     To evaluate the values of portosystemic shunt and other interventional radiology approaches     for treatment of symptomatic portal hypertension in patients with cavernous transformation of     portal vein.   "
59707|NCT02504021|"     A randomized clinical trial for patients with end stage renal disease in which a family     consultation condition is compared against a treatment as usual control condition on the     hospital readmissions after 1 month as the primary outcome variable.   "
59708|NCT02504008|"     This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the     efficacy and safety of AXS-02 in patients with CRPS-I.   "
59710|NCT02503982|"     Valganciclovir is extensively used for cytomegalovirus (CMV) infection treatment and     prophylaxis after solid organ transplantation (SOT). VGC dosing is problematic in children.     valganciclovir has variable absorption and is renally excreted. Area Under the Curve (AUC)     (0-24) of 40-60 mcg∙h/L is a predictive pharmacokinetic parameter of efficacy and safety.     Dosing based on manufacturer recommendations is supra-therapeutic in most cases. A few     published dosing algorithms result in AUC out of range.      Objective: To prospectively validate a Valganciclovir administration dosing regimen and     compare it to other dosing algorithms.      Methods: Children after SOT at Schneider Children's Medical Center, the largest tertiary     pediatric center in Israel, were prospectively studied, starting Dec 2014. The dosing regimen     was derived from Seattle Children's Hospital guidelines; 14-16 mg/kg/dose. For impaired renal     function, stratified dose reduction was used. Blood was withdrawn at steady state: 2, 5 and     10 hours post dosing. Drug level was analyzed by high pressure liquid chromatography (HPLC).   "
59711|NCT02503969|"     The primary aim of this project is to examine the association between having a long-term     condition (morbidity) and screening uptake for colorectal cancer. Whilst this project will     consider all morbidity and co-morbidities, there will be a particular focus on common mental     health disorders, such as depression and anxiety.      The secondary aim of this project is to examine other factors that may influence uptake rate.     Information on a wide array of potential factors is available for this project. These include     demographics (age, gender, ethnicity), socio-economic status (deprivation, education status)     and lifestyle (smoking status, drinking patterns, degree of exercise). In addition, any     potential moderating effect of these factors on the association between morbidity and     screening uptake shall be explored.      In summary, the following shall be explored:        -  Uptake rates by type of mental health disorder.        -  Uptake rates by chronic physical health problems.        -  Associations between uptake, morbidity (both physical and mental) and broader health          determinants such as demographics, socio-economic status and lifestyle.   "
59712|NCT02503956|"     Assessing efficacy of punctal dilatation with insertion of perforated punctal plugs for the     management of acquired punctal stenosis due to allergic conjunctivitis in otherwise healthy     patients.   "
59713|NCT02503943|"     Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese diabetes     patients are combined with dyslipidemia or hypertension. The clustering of diabetes, obesity,     hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1     (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported     that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could     decrease blood pressure and improve lipid metabolism. Therefore, activation of GLP-1 receptor     may become a new comprehensive treatment strategies for improving glucose and lipid     metabolism, blood pressure level and cardiovascular complication. But, it is lack of     evidence-based medicine proof on the relationship between GLP-1 and blood pressure or serum     lipid. So, investigators designed a prospective, randomized, open-label, active control     study, and try to evaluate the effects of activator of GLP-1 receptor (liraglutide) on     lowering blood pressure, improving vascular function and lipid metabolism in overweight or     obese type 2 diabetic patients with masked hypertension.   "
59755|NCT02503397|"     This study evaluates auditory neural maturation by auditory brainstem evoked response in late     preterm and term infants with in utero iron deficiency compared with neonates with normal in     utero iron status.   "
83154|NCT02197572|"     The purpose of this study is to characterize the effect of a single dose of 40 mg MLN0128 on     the electrocardiographic QT/QTc interval in participants with advanced solid tumors.   "
59714|NCT02503930|"     The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous     every day phenomena. For example, people frequently walk while talking on a cellphone or     drive while talking to a passenger. Often, the performance of one or more of these     simultaneously performed tasks may deteriorate when another task is carried out at the same     time, even in healthy young adults. This reduction in performance is referred to as the DT     deficit or DT cost and is typically much higher in patients with Parkinson's disease (PD)     than in young adults or age-matched controls. In PD, this DT cost impairs the gait pattern,     as manifested, for example, in increased gait variability, exacerbating instability and fall     risk.      In the proposed study, would be evaluated the effects of tDCS on dual tasking performance     following tDCS.      The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will     increase DT performance and prefrontal activation.   "
59715|NCT02503917|"     This study will establish the feasibility and accuracy of localising and outlining the uterus     on ultrasound images using both healthy volunteer and cervical patient cohorts. This will     enable us to determine whether or not ultrasound will be a good option to ensure the correct     patient position prior to radiotherapy for cervical cancer patients.   "
59716|NCT02503904|"     The principal aim of the present research is to compare two methods of antibiotic delivery:     concomitant tumescent antibiotic delivery (TAD) and intravenous antibiotic delivery (IVAD)     versus IVAD alone, (TAD+IVAD vs IVAD), with respect to the prevention of surgical site     infections (SSI). The investigators hypothesize that TAD+IVAD will significantly reduce the     incidence of SSI compared to IVAD.      TAD is the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of     tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L),     epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.      A secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention     of post-operative venous thromboembolism (VTE).   "
59717|NCT02503891|"     M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide -     MP-1™.      M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing     process and supplies them to the customer.      The aim of this study is to evaluate, in the frame of PMCF, the safety and performance of     using AL-X MP1 Polyimide Acetabular liners in Total Hip Replacement surgery by clinical     following up of patients for a period of 2 years .   "
59718|NCT02503878|"     Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to     monitor levels of sedation based on a bilateral 4-channel electroencephalogram (EEG). The     purpose of this study is to observe the effectiveness of the Sedline monitor to detect the     unilateral hemispheric EEG changes seen in Wada testing   "
59719|NCT02503865|"     Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis   "
59721|NCT02503839|"     Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug     resistant (MDR)-TB there is restricted treatment options. This calls for research of new     immune-modulating treatment strategies that can strengthen the patients immune system to     better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator     prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue.     Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve the     immune system and strengthen vaccines responses.      Hypothesis        1. A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune          responses that favour TB survival, but this can be abrogated by COX-2i.        2. TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine          and enhanced by COX-2i will improve immune-mediated host clearance of TB.        3. Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB chemotherapy          offer new treatment modalities for TB, including MDR/XDR-TB.      Approach to test the hypothesis        1. Study design: 4-arm, open and randomized clinical intervention trial of patients          starting treatment for active TB in specialized Norwegian TB centres and where two arms          will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only          and the last arm serve as control receiving only standard anti-TB therapy. For safety          precautions, only patients bearing sensitive TB strains are included and study arms will          be sequentially introduced.        2. In a mouse model examine in more detail the effects of reversion of chronic inflammation          with COX-2i locally in tissue and the interplay with TB vaccine responses, immune          regulation, correlates of protection and survival in a well-characterized model for          TB-exposed mice.   "
59722|NCT02503826|"     Effective postoperative pain control is essential for patients and inadequate postoperative     pain relief can cause mental and psychological sufferings. Despite the growing concern on     postoperative pain management, acute postoperative pain is still poorly managed. Though     numerous clinical practice guidelines for postoperative pain management have been published     throughout the last decades, inadequate pain relief remain a big health care issue.     Sufentanil has been used as satisfied pain control drug because of its strong potency of     analgesia for a long while. But its use in patient controlled intravenous analgesia (PCIA)     has not been clarified. And the dilemma of safety concern and insufficient dosage of     analgesic is a common problem. Thus the investigators design this prospective randomized     controlled double blinded trial to observe the efficacy and the optimal dose of sufentanil in     PCIA in patients underwent moderate surgery for the purpose of providing reference in     clinical practice.   "
59723|NCT02503813|"     One required examination for declaration of death by neurological criteria is the apnea     challenge test. The apnea challenge test evaluates the medulla brainstem respiratory center     response to a rise in CO2. The current guideline requires arterial sampling of CO2 and     therefore either arterial puncture or arterial catheter placement for the examination.     Arterial catheter is an invasive monitoring device and is not without complications. Recent     studies have demonstrated that there is a direct correlation between peripheral venous and     arterial blood gas measures and that peripheral venous CO2 measures may be used as     alternatives to arterial CO2 measure.The purpose of this study is to evaluate brainstem     response during the apnea challenge test to a rise in venous CO2 and correlate it with the     rise in arterial measured CO2. The objective of this study is to demonstrate a similar rise     between the venous and arterial CO2 during the apnea challenge test and eliminate the     necessity of arterial blood sampling for the sole purpose of apnea challenge test in the     future.   "
59724|NCT02503800|"     The investigators wish to evaluate the association between tryptase values as well as c-Kit     mutation and adverse effects in the course of immunotherapy. The investigators also intend to     assess the effect of immunotherapy on tryptase levels.   "
59727|NCT02503761|"     Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature     organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to     narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new     agents with a wider spectrum of activity.      Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It     is well tolerated by children and neonates, including preterm babies, and allowing     monotherapy instead of combined therapy.      Severe neonatal infections with increasing antibiotic resistance are major problems affecting     morbidity and mortality in the NICU. Few number of new antibacterial agents entering the     clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be     available in the near future.   "
59728|NCT02503748|"     In a participatory process involving urologists and former patients, the project team has     developed an online information system (tutorial) for patients with localized prostate     cancer. In this field test, relevant outcomes are measured and the tutorial will be tested     for its clinical applicability.   "
59729|NCT02503735|"     Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD)     who are treated with Harvoni for 12 weeks have improvements in their kidney disease.   "
59730|NCT02503722|"     This phase I trial studies the side effects and best dose of transducer of regulated CREB     activity 1/2 (TORC1/2) inhibitor INK128 when given together with epidermal growth factor     receptor (EGFR) inhibitor AZD9291in treating patients with advanced EGFR mutation positive     non-small cell lung cancer that has spread to other places in the body (advanced) and has     progressed after treatment with an EGFR tyrosine kinase inhibitor. TORC1/2 inhibitor INK128     and EGFR inhibitor AZD9291 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
59731|NCT02503709|"     This phase I trial studies the side effects and best dose of onalespib and CDKI AT7519 in     treating patients with solid tumors that have spread from the primary site (place where they     started) to other places in the body (metastatic) or cannot be removed by surgery. Onalespib     and CDKI AT7519 may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
59732|NCT02503696|"     The primary objective of this study is to gather stool samples from subjects with     inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be     utilized to help select molecular markers and determine the optimal sensitivity and     specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).   "
59733|NCT02503683|"     The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and     Pharmacodynamics of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and     Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.   "
59734|NCT02503670|"     The purpose of this study is to develop and pilot test HealthyDads.ca, a website for     expectant first-time fathers who have known risk factors for depression.   "
62083|NCT02472964|"     A multicenter, double-blind, randomized, parallel-group, Phase III study of the efficacy and     safety of Hercules( Myl 1401O, Mylan Trastuzumab) plus taxane versus Herceptin® plus taxane     as first line therapy in patients with HER2-positive metastatic breast cancer.   "
59735|NCT02503657|"     This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month     open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in     moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally     administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF     per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are     planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching     placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will     consist of males and females ranging in age from 21 to 80 years old, inclusive.      The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26     week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a Follow-up     Visit (within 4 weeks after the last dose).   "
59736|NCT02503644|"     Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin.     It is a life-threatening orphan disease with severe physical and psychosocial consequences.     IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two     dose levels with a placebo control treatment. Patients will be unaware of the treatment they     are receiving and will be randomized to one of three treatment arms , either IVA337 400mg     bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that     time assessments will be made to monitor both the efficacy and safety of the treatment.   "
59737|NCT02503631|"     The primary objective of this study is to obtain de-identified, clinically characterized,     stool and plasma specimens for use in assessing new markers for the detection of neoplasms of     the digestive tract.   "
59738|NCT02503618|"     The scientific purpose of this study is to look at how substance use may relate to human     immunodeficiency virus (HIV) infection among young black men who have sex with men in     Atlanta.   "
59739|NCT02503605|"     Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step     in simplifying fertility treatments, making them easier to manage and more accessible to     patients. Taking in mind these arguments ,the study is proposed for determining equivalence     in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar     recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.   "
59740|NCT02503592|"     This study will measure the effects of soft surgical techniques on vestibular function and     quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the     investigators will attempt to systematically evaluate the utility of different     electrophysiological measures of vestibular system function in surgical ears.      Vestibular system function in CI patients will be evaluated pre-surgically and twice     post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques -     such as VNG, rotational testing, and air conduction VEMPs - will be compared to and     cross-checked with newer techniques including video head impulse testing (vHIT) and bone     conduction VEMPs.   "
59741|NCT02503579|"     This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in     the relationship between physical fitness/activity and executive functions in typically     developing children and children with Autism Spectrum Disorder, Development Coordination     Disorder , Attention Hyperactive Disorder.   "
60053|NCT02499523|"     A prospective, interventional, monocentric, controlled and randomized study will compare a     conventional surgical technique to a surgical technique with the assistance of the Acetabular     Cup Orientation Guide (ACOG, Materialise) System during total hip replacement (THR).   "
59742|NCT02503566|"     Cardiac allograft vasculopathy (CAV) is characterized by marked intimal proliferation and     concentric vascular thickening and fibrosis. CAV remains the leading cause of late morbidity     and mortality in heart transplant recipients. Optical coherence tomography (OCT) is a new     generation catheter-based modality that acquires images at a spatial resolution of 10-20 μm     which is 10-fold greater than that of intravascular ultrasound (IVUS). OCT is currently the     most sensitive imaging technique for early CAV detection. Recent studies proved that     circulating human leukocyte antigen (HLA) directed donor-specific antibodies correlate with     increased mortality and CAV. Contradiction of scientific results has been reported regarding     increased resting heart rate and development of CAV. Larger prospective studies using more     sensitive CAV detecting methods are required to enhance our understanding. Novel     immunosuppressants, mechanistic target of rapamycin (mTOR) inhibitors, may attenuate CAV     progression and may improve long-term allograft survival owing to favorable coronary     remodeling.      Aim of the study: Use OCT imaging for identification of patients with early rapid progression     of CAV (rapid progressors) and to identify the critical risk factors responsible for CAV     progression. The impact of conventional and heart transplant (HTx) specific risk factors,     such as donor-specific antibodies or rapid heart rate will be studied in a prospective,     national-level cohort study. The implication of OCT results will lead to adjustment of     immunosuppressive therapy in one year after heart transplant to prevent further progression     of the disease in CAV rapid progressors.      Working hypotheses:        1. Patients with rapid progression of cardiac allograft vasculopathy can be identified by          increased titers of donor specific anti-human leukocyte antigen (anti-HLA) and/or          antibodies against major histocompatibility complex (MHC) class I-related chain A (MICA)          antibodies.        2. Specific high-risk characteristics of anti-HLA antibodies can be identified that are          associated with particularly high rate of CAV progression (vascular complement          activation in biopsies, certain HLA haplotypes).        3. Tachycardia in heart transplant recipients represents a risk factor for development of          cardiac allograft vasculopathy.        4. Influence of anti-HLA antibodies and increased heart rate is independent of already          established risk factors of CAV.   "
59743|NCT02503553|"     Identifying and making a decision about the best health treatment or screening option can be     difficult for patients. Decision aids can be used when there is more than one reasonable     option, when no option has a clear advantage in terms of health outcomes, and when each     option has benefits and harms that patients may value differently.      Decision aids may be pamphlets, videos, or web-based tools. They make the decision explicit,     describe the options available, and help people to understand these options as well as their     possible benefits and harms. This helps patients to consider the options from a personal view     (e.g., how important the possible benefits and harms are to them) and helps them to     participate with their health practitioner in making a decision.      Cerebral aneurysms are common and potentially very dangerous. However, there are important     treatment choices that may prevent bleeding and stroke before aneurysm rupture.Current     procedural options are clipping and endovascular coiling. The anatomy of most aneurysms is     amenable to either treatment.      The treatment decisions are not simple, since each choice has its own trade-offs. How the     benefits and trade-offs are valued varies across different patients, and, therefore, the     right treatment decision needs to include greater patient participation. This starts with     better communication of the probabilities associated with the outcomes of each option in     terms that can be understood by patients. Equally important is helping the patients clarify     their own treatment goals, as well as legitimizing patients' partnership in the     decision-making process. Tools (e.g., decision aids) to achieve shared decision-making, are     lacking in this area of medicine. We propose to investigate the impact of such decision aids     on patient satisfaction and the outcomes of cerebral aneurysm coiling and clipping.      Aim 1. To determine whether structured decision aids offered to cerebral aneurysm patients     are associated with increased patient participation in the decision making process as     indicated by the OPTION score      Aim 2. To determine whether structured decision aids offered to cerebral aneurysm patients     are associated with improved quality of life and patient satisfaction outcomes immediately     preoperatively, and 30 days postoperatively.   "
59826|NCT02502565|"     An observational study to evaluate the prevalence of US changes of gout in the joints and     tendons of patients with different degrees of asymptomatic hyperuricemia. The investigators'     findings may support the extension of the spectrum of urate disease, and define a subset of     patients that may benefit from early urate-lowering therapy.   "
59744|NCT02503540|"     This interventional study will evaluate the retinal vascular dynamics associated with     Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or     macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein     angiography and OCT angiography will be performed at multiple timepoints to assess the     changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the     study duration and compare these alterations to baseline.   "
59745|NCT02503527|"     The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube     feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically     ill patients receiving insulin treatment for blood glucose management.   "
59746|NCT02503514|"     Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic     agents will be evaluated for incidences of paradoxical immune reactions, the risk factors     associated with those paradoxical immune reactions, and whether the paradoxical immune     reactions and their associated risk factors differ based on formulation of biologic agent.      Participants: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to     initiate treatment in 1 month      Procedures (methods): Subjects undergoing treatment with a biologic agent will be followed     indefinitely for paradoxical immune reactions. Data will be collected at baseline as well as     serum and plasma for banking. Subjects will be followed at 6 month intervals either via     email, telephone interviews or at the time of clinic follow-up visits. In the event of a     de-novo paradoxical reaction, specific information will be collected from sites in an event     capture form, with data abstracted from routine clinical care for the paradoxical reaction.     Subjects will continue to be followed every 3 months after the event via email, telephone     contact to determine whether resolution and/or recurrence occurred, and to determine any     changes in medical therapy. Serum and plasma will be re-collected at the time of first event     for comparison to baseline samples and to samples from controls (those on biologics without     study documented paradoxical immune reactions). At resolution of the event, patient will     return to 6 month follow up schedule. Subjects can discontinue and/or fail a particular     biologic treatment; therefore they will also be followed for paradoxical immune reactions, on     any new biologic treatment they undergo while in the study.   "
59747|NCT02503501|"     This study evaluates the safety and effectiveness of intranasal (IN) glulisine in patients     with amnestic mild cognitive impairment (aMCI) and probable Alzheimer's disease. Half of     participants will receive IN glulisine, while the other half will receive IN placebo.   "
59748|NCT02503488|"     The purpose of the current study is to examine the psychological well-being of youth within     the context of participation in political violence during the 2015 election period in     Burundi. In detail, the investigators are interested in fostering improved outcomes in a     peace-building initiative aimed at youth in Burundi by reducing the mental health-related     stress of the initiative's most severely affected participants. In addition, the     investigators are interested in learning more about the youth experience of involvement in     the Burundian political system in an effort to understand the links between youth engagement     in political violence and past experiences of traumatic events.   "
59749|NCT02503475|"     The purpose of the Stanford Center for Back Pain is to investigate and characterize the     mechanisms of four treatments for chronic low back pain. These interventions (research     treatment) include real-time fMRI neurofeedback, mindfulness based stress reduction,     cognitive behavioral therapy, and acupuncture treatment. The investigators plan to     characterize both mechanisms of treatment effects and efficacy.   "
59750|NCT02503462|"     The purpose of this study is to assess whether a boosting by cobicistat results in similar     concentrations of darunavir in the brain compared to a boosting by ritonavir.   "
62043|NCT02473484|"     The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass     spectrometry imaging (MALDI MSI). In order to provide more specific informations for the     diagnosis and the prognosis of high grade glioma.   "
59756|NCT02503384|"     Background: In mainland China, the development of pediatric liver transplantation (LT) has     lagged behind that of adult LT during the past two decades, but it has been progressing     immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric     transplant center in mainland China.      Aim and method: This study is performed for establishment of key techniques for pediatric LT     in mainland China, including the indications and timing for pediatric LT, the criteria for     donor selections, living donor LT planning, prevention and treatment for posttransplant     complications, long-term follow-up management et al.   "
59757|NCT02503371|"     Since its introduction in 1978, over 3.75 million babies have been born using in vitro     fertilization (IVF). Maturing ovarian follicles lead to a large rise in estrogen to     supra-physiological levels . This increase in estrogen has been shown to cause a     hypercoagulable state, leading at times to arterial and venous thrombosis.(Thromboelastogram     (TEG) is a point of care whole blood hemostatsis analyzer mimicking in vivo conditions and     measuring visco elastic properties of the clot. The TEG shows effect of most of the     components of hemostatsis: coagulation factors, fibrinogen, platelets and fibrinolysis.     Components of TEG include R, reflecting coagulation factor cascade, alpha angle and K     measurements reflecting fibrin function, MA reflecting mostly thrombocyte function,     coagulation index (CI) measuring global hemostatic statis and LY30 measuring fibrinolysis.      In this study the investigators would like to measure serum estrogen levels and (TEG) in     parturients at the beginning and conclusion of an IVF simulation cycle and evaluate how it's     influnence on coagulation parameters, and wheather or not a large sample size will effect     primary outcomes.      Secondarily the investigators would like to see if estrogen levels are predictors of     coagulation parameters and see if age influences TEG parameters   "
59758|NCT02503358|"     This randomized phase I trial is studying the side effects and the best dose of selumetinib     when given together with paclitaxel as a second line therapy in treating patients with stage     IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor     cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for     cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving selumetinib together with paclitaxel may kill more tumor     cells.   "
59761|NCT02503319|"     The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral,     is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum     period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum     hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal     delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called primary     when blood loss arose within 24 hours after birth.      This is a open-trial randomized, longitudinal, controlled that including 486 subjects .   "
59762|NCT02503306|"     Primary Objective:      o To assess the change in percent of sexual attempts in which subjects are able to maintain     an erection of sufficient duration to have successful intercourse between the run-in period     and treatment period:        -  The change in percent of sexual attempts in which subjects are able to insert the penis          into the partner's vagina.        -  The change in score on the erectile function (EF) domain of the International Index of          Erectile Function (IIEF) questionnaire.      Secondary Objective:      o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction     (ED).   "
59763|NCT02503293|"     A randomised, cross-over study to compare quality of life and satisfaction in primary     immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL     administered with two different delivery devices: injections using pump or rapid push.   "
59764|NCT02503280|"     Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this     phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection     Catheter System will be tested. The randomized portion of the study will be conducted after a     full review of the safety data from the pilot Phase by the Data safety monitoring board.      Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac     catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline.      Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.   "
59765|NCT02503267|"     The objective of the study is to investigate congenital disorders of glycosylation in     congenital heart diseases without a clear molecular or genetic basis.   "
59766|NCT02503254|"     The overall goal of the study is to demonstrate the reduction of biomarkers of exposure     (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers     switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0     (CHTP 1.0) as compared to smokers continuing to use CC.   "
59767|NCT02503241|"     The goal of this interventional crossover study in morbidly obese intubated and mechanically     ventilated patients is to describe the respiratory mechanics and the heart-lung interaction     at titrated positive end-expiratory pressure levels following a recruitment maneuver with     transthoracic echocardiography and electric impedance tomography imaging.   "
59838|NCT02502409|"     This study will examine two groups of subjects with factor IX (FIX) deficiency: 1) those with     a current or history of inhibitors to FIX, and; 2) groups of two or more affected brothers,     with or without inhibitors. The overall goal is to characterize the study groups in terms of     their medical history, their patterns of bleeding, their care, quality of life, and     complications including the development of joint disease, inhibitory antibodies to FIX, use     of immune tolerance induction (ITI) and outcome.   "
59839|NCT02502396|"     The primary objective of this study is to evaluate the practice patterns of rivaroxaban usage     invenous-thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) in cancer     patients.      The secondary objectives are to evaluate outcomes such as recurrent VTE, stroke and bleeding     for cancer patients on rivaroxaban.   "
59768|NCT02503228|"     Patients who have a large enough defect in their knee cartilage will sometimes undergo     surgery to transplant donor cartilage tissue into their defect in an attempt to repair the     knee. The donor cartilage tissue must be fully tested for disease and contamination before it     can be placed into a patient. This time, along with the time needed to coordinate the surgery     and transport the tissue to the hospital, can be substantial. Cartilage tissue does not last     for long outside a body and the fresher the tissue is, the more likely it is that the patient     receiving the transplant will heal better.      The MOPS was developed to preserve the cartilage tissue better than the currently standard     preservation system is able to. Patients that are enrolled into this study will receive     cartilage tissue that has been stored in the MOPS instead of the currently standard     preservation system. Their surgical procedure will not change and be performed as per usual.     The patient will then be followed for a period of two years in which their progress will be     assessed using surveys and the healing and integration of the transplanted tissue will be     assessed using diagnostic imaging and blood and urine samples.   "
59769|NCT02503215|"     To study the effects of compression stockings on sleep apnea in hemodialysis patients with     diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift     theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper     airways edema.      The aim of this study is to evaluate if compression stockings could improve such nocturnal     volume redistribution and, therefore, improve obstructive sleep apnea.   "
59770|NCT02503202|"     The study will evaluate the safety and immunogenicity of 3 consistency lots and a high-dose     lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this     study is to demonstrate consistency in the immune responses of participants receiving 3     separate lots of V920 (at release dose) through 28 days postvaccination. A subset of     participants representative of all treatment groups will continue through 24 months     postvaccination in the extension study for the evaluation of safety, and durability of immune     response. Safety of the vaccines and matching placebo will be evaluated through 6 months     postvaccination for all participants and through 24 months postvaccination for participants     continuing in the study extension.   "
59771|NCT02503189|"     The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to     evaluate safety in dry eye patients with Sjögren's syndrome   "
59772|NCT02503176|"     The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in     dry eye patients with Sjögren's syndrome.   "
59857|NCT02502071|"     The purpose of this study is to determine whether alkalinization of urine uric acid by 2     doses of sodium bicarbonate (1950mg) over 24-hours reduces precipitation and crystallization     of urine uric acid over in adults with type 1 diabetes.   "
59773|NCT02502201|"     The purpose of this research study is to determine the effect of the environment on     six-minute walk test performance in individuals with chronic obstructive pulmonary disease     due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the environmental     impact on physical performance in this population to determine if any factors influence     quality of life. This study was developed to evaluate the efficacy of the using the indoor     six-minute walk test to determine eligibility for ambulatory oxygen therapy.   "
59774|NCT02502188|"     To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of     CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis.   "
59775|NCT02502175|"     Opioid-dependent patients seeking maintenance treatment will be recruited. Each participant     will be allocated to one of the two study groups with the equal chance of receiving either     opium tincture or methadone. Participants, clinical and research staff will not be aware of     the medication that each patient receives. This study aims to test whether opium tincture is     equally effective as methadone at retaining participants with opioid dependence in     substitution treatment.   "
59776|NCT02502162|"     The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of     complex regional pain syndrome (CRPS). Study participants will be randomly assigned to     receive either LDN or placebo for a period of several weeks. During this period participants     will be asked to come to several visits, which will include sensory testing, physical     assessments, and questionnaires.   "
59777|NCT02502149|"     The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant     coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of     2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously     treated participants with severe hemophilia A. The secondary objectives are: to characterize     the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of     treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial     and a higher strength vial; and to evaluate the safety of rFVIIIFc manufactured at the 15K     scale.   "
59778|NCT02502136|"     The purpose of this study is to assess the differences of safety and efficacy of carbon     dioxide insufflation instead of air during sedated or unsedated endoscopy.   "
59779|NCT02502123|"     This study will prospectively assess long term heath related quality of life in chronic     migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as     standard of care.   "
59780|NCT02503163|"     The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in     dry eye patients with Sjögren's syndrome.   "
59781|NCT02503150|"     This trial is to compare the efficacy and safety of modified FOLFOX6 [mFOLFOX6, a specific     chemotherapy regimen of Oxaliplatin ,5-Fluorouracil and Leucovorin] chemotherapy plus Antigen     Pulsed Dendritic Cells (APDC，a kind of autologous tumor lysates pulsed human dendritic cells     vaccine) with modified chemotherapy alone in patients with metastatic colorectal cancer.   "
59782|NCT02503137|"     This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of     0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical     analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554     and compared to placebo may lead to a greater understanding of the underlying mechanisms of     action of SM04554.   "
59783|NCT02503124|"     A randomized controlled trial comparing wake therapy (single night) followed by bright light     therapy to treatment as usual.   "
59867|NCT02501941|"     Hypothesis: Cortical spreading depolarizations are inhibited by the NMDA receptor antagonist     Ketamine Aim 1: To demonstrate, in a group of patients with acute severe brain injury     requiring surgery including traumatic brain injury and aneurysmal subarachnoid hemorrhage,     whether use of continuous infusion of ketamine decreases frequency of occurrence of cortical     spreading depolarizations.   "
59784|NCT02503111|"     Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide.     Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several     cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal     infection with these HR-HPV strains and the resultant high-grade anal dysplasia and anal     cancer are much higher in men who have sex with men (MSM) than in the general population.     Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making     the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer     prior to the adoption of routine cervical cytology screening. Despite these alarming     statistics, there are no established protocols for optimal screening and treatment of anal     HPV and cancer precursors, nor has there been any widespread rollout of organized screening     programs anywhere in Canada. Further, not only does HPV directly cause significant disease in     these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual     transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies     in care for HIV-positive MSM.      The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team will recruit a large     group of MSM to carry out a number of different studies. One key component of recruitment     entails the mailing of invitations with educational materials in an invitational package to     subjects in order to determine who would be interested in having anal cancer screening. In     this way, the investigators will reveal factors that are important in acceptance of     screening.      The HPV-SAVE team brings together community and internationally-recognized experts in HPV and     HIV disease and mucosal immunology, to better define the optimal approaches for primary and     secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and     to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor     for HIV transmission. This will yield critical information which can lead to improvement in     the health of MSM, and will provide a foundation on which to build further, large-scale     screening and treatment trials on a national level.   "
59785|NCT02503098|"     This study will augment an existing mobile application for individuals with eating disorders     by developing adaptive, tailored content targeting remediation of cognitive distortions. The     adaptive application will be deployed and assessed for efficacy relative to the standard     product in a randomized controlled trial.   "
59786|NCT02503085|"     The purpose of this study was to determine the rate and extent of absorption of Ibuprofen     suspension formulations.   "
59787|NCT02503072|"     The goal of this study is to identify ways for implementing small prizes allocated by a     drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala,     Uganda. The study is called Rewarding Adherence Program (RAP).   "
59788|NCT02503059|"     Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in     moderate / severe plaque and the reasons that led to the abandonment. Besides factors that     might have had a positive or negative influence on adherence to treatment and analysis of     efficacy (PASI 75) and safety will be identified.      All variables were collected through retrospective review of medical records of patients     dermatology unit are made.   "
59791|NCT02503020|"     Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and     docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated     cell membranes in the central nervous system, including in the retina, hence the great     importance of them for appropriate visual and cognitive development.      In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor     development in very preterm infants who had diets supplemented with different LCPUFA amount     of AA to support the importance of sufficient AA values in formula.   "
59792|NCT02503007|"     Sustained high-intensity activity, such as survival training with little nourishment     available, can result in a loss of muscle performance. This study will examine the effects of     a nutritional supplement to maintain muscle and muscle performance during this period.   "
59793|NCT02502994|"     This study is designed to evaluate the safety and efficacy of a single injection of GEN0101     in patients with recurrence of castration resistant prostate cancer.      The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and     followed subcutaneous injection) and two weeks of observation as one cycle treatment period.     Each subject receive two cycle treatment period.      Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per     injection of GEN0101 Each group included minimal 3 subjects.   "
59794|NCT02502981|"     In stage 3 chronic kidney disease (CKD) the risk of death due to cardiovascular causes is     high and greatly exceeds the risk of progression to end stage renal failure. This high     cardiovascular risk is predominantly due to sudden cardiac death and heart failure,     manifestations of left ventricular hypertrophy and fibrosis. Aldosterone appears to play an     important role in the causation of this myocardial disease both by direct inflammatory and     fibrotic myocardial effects and via increased arterial stiffness due to hypertrophy,     inflammation, and fibrosis within the media of large arteries. Levels of aldosterone are high     in CKD despite sodium overload and treatment with angiotensin-converting enzyme (ACE)     inhibitor or angiotensin receptor blocker (ARB) drugs due to the twin phenomena of     aldosterone escape and breakthrough. In a previous British Heart Foundation funded study,     Birmingham investigators showed that the addition of the mineralocorticoid receptor blocker     (MRB) spironolactone to background therapy with ACE inhibitors or ARBs caused reductions in     the prognostically important parameters of arterial stiffness and LV mass. Because     spironolactone therapy was also associated with significant falls in arterial pressure it     remains possible that these effects were mediated simply by blood pressure reduction. In this     multi-centre, randomised controlled study, the effects of treatment with spironolactone on LV     mass and arterial stiffness in patients with stage 3 CKD on established ACE or ARB therapy     will be compared to those of chlortalidone, a control anti-hypertensive agent. Early stage     chronic kidney disease is highly prevalent and new, cost effective treatment strategies are     required to reduce cardiovascular risk. This study is designed to provide the rationale for a     larger study of morbidity and mortality with MRB therapy in early stage CKD.   "
59795|NCT02502968|"     This study evaluates the addition of BL-8040 to the standard consolidation therapy with     cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants     will receive BL-8040 and cytarabine in combination, while the other half will receive placebo     and cytarabine.   "
59796|NCT02502955|"     Today complex vascular and cardiological interventions are performed in severely ill     patients.      Autopsy is the reference standard for quality control for almost two centuries, but autopsy     rates for patients dying in hospitals are decreasing rapidly.      Virtual autopsy has shown to be a good alternative for classic autopsy.   "
59868|NCT02501928|"     The purpose of this study is to investigate the safety and tolerability of fesoterodine     following once daily long-term treatment in Japanese pediatric neurogenic detrusor     overactivity (NDO) subjects.   "
59797|NCT02502942|"     Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the     upper airway during sleep. OSA patients have a small upper airway that is kept patent during     wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g.     genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in     upper airway narrowing or collapse. Previous studies of upper airway muscle training showed     variable results on OSA, but so far there has not been any practical, long-term, systematic     upper airway muscle training developed or studied as the treatment of OSA. In theory,     strengthening the upper airway muscle with exercise training in theory helps maintain a     patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA muscle     training can improve sleep apnea in some patients with OSA, including those already receiving     treatment with PAP or oral appliance therapy. 2) Muscle training is a viable therapy for a     definable subset of OSA patients. Investigators hypothesize that patients with OSA who have     mild or moderately compromised upper airway anatomy will benefit the most. 3)There will be a     positive association between the changes in muscle function and improvement in OSA severity.   "
59798|NCT02502929|"     The primary aim of the study is to compare the effect of three different interventions on     lifestyle risk factors and biological risk factors for type 2 diabetes in depressed     Cambodians. The three different interventions are lifestyle, lifestyle plus medication     therapy management, and enhanced standard care.   "
59799|NCT02502916|"     The aim of this study is to evaluate the potential role of the enteral feeding systems on the     bacterial colonization of premature infants during their NICU admittance and its evolution     after 2 years, which is the age when the infant's gut starts to contain an adult-like     microbiota.   "
59800|NCT02502903|"     Prospective, double-blind, randomized, placebo-controlled First-In-Human study with three     sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs),     Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in     patients with a complement-mediated disorder.   "
59801|NCT02502890|"     Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness     of breath, chest tightness, and cough. A cold that is caused by a virus (viral cold) can     sometimes make asthma symptoms worse. This study will help investigators learn about the way     colds are related to asthma attacks among children who need higher amounts of medications to     control their asthma. Investigators want to learn why viral colds sometimes cause asthma     attacks and other times do not by studying the immune system response in samples taken from     the nose and blood.   "
59802|NCT02502877|"     The present study is a pilot study aiming to compare the variation in core temperature     (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to neuraxial     anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.   "
59803|NCT02502864|"     The purpose of this study is to adjust the amount of docetaxel participants receive based on     the level of docetaxel measured in their blood. This method of dose adjustment is called     pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of     docetaxel using this method will lessen the side effects associated with docetaxel in cancer     treatment.   "
59807|NCT02502812|"     Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate     (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way     cross over, six sequence study to investigate the relative bioavailability of two 75     milligrams (mg) clopidogrel tablet formulations (clopidogrel SB224326 test formulation 1     [Clop F1] and clopidogrel SB224326 test formulation 2 [Clop F2]) compared with the reference     product (innovator) in healthy human subjects. A total of 18 healthy human subjects will be     randomized, such that approximately 14 evaluable subjects complete the study. Total duration     in the study for each subject will be approximately 8 weeks from screening to the follow-up     visit.   "
59880|NCT02501772|"     For diabetic patient with persisted albuminuria under the intensive control on blood pressure     and blood glucose, the non-invasive method of acupressure at Sanyinjiao (SP6) is easy to use     and significantly effect on albuminuria reduction in patients of diabetic nephropathy.   "
66505|NCT02415205|"     The study will measure the effects of eye exams on markers of stress in the urine. In     addition, measurements will be taken to show the effects of stress on brain activity, O2     sats, and blood flow.   "
59808|NCT02502799|"     Individuals with ADHD are at markedly high risk for increased substance use and Substance Use     Disorder (SUD). Given the strong evidence for the negative trajectory of individuals with     co-occurring ADHD and substance use initiation, the goal of this study is to conduct a     controlled examination of a brief, early intervention (BEI) for substance modified for     adolescents with ADHD. Importantly, this intervention will address individuals who are at     risk for problems with substance use, but do not yet meet criteria for severe SUD.      Although brief interventions have been found to be effective in other populations, their     efficacy in an ADHD population with emerging risk for substance use problems remains     uninvestigated. This study aims to understand why some adolescents with ADHD and elevated     risk for SUD respond to (BEI) and others do not. The investigators will test whether     situational and individual characteristics predict substance use development and response to     treatment. Further, this study will assess which types of additional treatment are most     effective for youth who do not respond to the initial BEI. It is hypothesized that rates of     adolescent substance use will be lower among adolescents who participate in study treatments.   "
59809|NCT02502786|"     The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8)     and a drug called GM-CSF have on the patient and whether it can keep the patient in remission     longer and/or prevent recurrence of the disease.   "
59810|NCT02502773|"     The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6%     Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy     is associated with a difference in morbidity and mortality within the first 14 days in     patients at moderate-to-high risk of postoperative complications after abdominal surgery.   "
59811|NCT02502760|"     The purpose of this study is to determine if a program of physical activity, nutritional     supplements and relaxation techniques is effective at decreasing post operative complications     in frail colorectal cancer patients undergoing resection.   "
59812|NCT02502747|"     Study Objectives: To determine whether, in patients with large acute myocardial infarction     undergoing primary or rescue angioplasty, the administration of subcutaneous Lenograstim     [recombinant human Granulocyte-Colony Stimulating Factor (rhu G-CSF), Myelostim 34,     Italfarmaco] associated with Myocardial Contrast Echocardiography and the intravenous     infusion of sulphur hexafluoride (Sonovue, Bracco) determines an improvement:        -  in regional and global contractile function, myocardial perfusion and infarct size          assessed by cardiovascular magnetic resonance.        -  Echocardiographic parameters of LV function        -  in the serum profile of inflammatory and mobilizing cytokines and of biomarkers of          myocardial damage and wall stress   "
59813|NCT02502734|"     This study will be conducted to evaluate the effect of once daily treatment with fluticasone     furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using     knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive),     will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the     eligibility criteria will enter the 2 week run-in period. After completing run-in period,     each subject will be randomly allocated to one of two treatment sequences: inhaled     fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate.     Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment     periods will be separated by a two-week wash-out period. Subjects completing two treatment     period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US     for adults and adolescents aged 12 and above.      ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.   "
59814|NCT02502721|"     A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate     pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.   "
59815|NCT02502708|"     This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune     checkpoint pathway indoleamine 2,3-dioxygenase (IDO), in combination with     temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma     model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation     significantly enhanced survival by driving a vigorous, tumordirected inflammatory response.     This data provided the rationale for the companion adult phase 1 trial using indoximod     (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open     (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the     clinic for children with brain tumors. This study will provide a foundation for future     pediatric trials testing indoximod combined with radiation and temozolomide in the up-front     setting for patients with newly diagnosed central nervous system tumors.   "
59816|NCT02502695|"     This is a research study for participants who have been diagnosed with lung cancer and are     receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall     objective of this study is to develop a database to collect data on participants who are     undergoing VATS lobectomy or segmentectomy for lung cancer.   "
59858|NCT02502058|"     The primary objective of this study is to determine if the use of a bone compaction process     (osseodensification) (Densah™ bur: Versah Osseodensification Company™) to prepare dental     implant sites, in human subjects, results in increased bone-ridge width, increased compact     bone in the outer wall of the prepared sites, and dental implant stability.   "
59817|NCT02502682|"     Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may     present with profound diarrhea, especially in those patients receiving antibiotics. Based on     a preliminary review of hospital data, the investigators have found that these symptomatic c.     diff infections occur with a relatively high incidence at Delnor Hospital. Notwithstanding     their high mortality, one recent study attributes a near quadrupling of hospitalization costs     to c. diff infections. Chlorhexidine baths have been shown in multiple randomized trials to     help reduce the incidence of highly virulent pathogens and hospital acquired infections.     Further, several studies show a favorable effect of reducing the incidence of c. diff     infections by using Chlorhexidine baths on ICU patients. Far fewer studies, however, have     focused on the effects of these baths on general medical/surgical wards. This investigation     seeks to study the effect of the daily use of 2% Chlorhexidine gluconate wipes in patients on     the general medical/surgical wards who are exposed to antibiotics for a suspected or     confirmed infection.   "
59818|NCT02502669|"     Double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and     safety of once weekly, high dose oral finasteride compared to placebo for the treatment of     severe nodulocystic acne in male subjects.   "
59819|NCT02502656|"     This study will evaluate the concordance of RAS mutation detection between the results     obtained from circulating tumor DNA and those obtained with the standard method (testing     from tumor tissue).   "
59820|NCT02502643|"     The purpose of this study is (1) The success rate of OK-432 pleurodesis after thoracic     surgery that air leak over 48 hours (2)The side effects and treatments of OK-432 pleurodesis.      [Methods] This study was a prospective, randomized, open-label, controlled study to evaluate     the effectiveness of OK-432 pleurodesis of persistent air Leak after pulmonary Resection. The     adult patient have persistent air leak >48 hours after thoracic surgery, will randomized to     OK-432 pleurodesis (OK-432 group) or normal saline pleurodesis (NS group). The trial will be     conduct from May 25, 2015 to May 25, 2018 in the Department of Surgery at national Taiwan     University Hospital, a medical center. The study protocol was approved by the hospitals'     Institutional Review Boards. A total of 80 cases, the subjects will be the hospital thoracic     surgery ward and received outpatient programs. Eligible Subjects : adults (minimum age> 20     years; maximum age ≦ 70 years old) patients with thoracic surgery and over48 hours of     continuous air leak. The exclusion criteria include: penicillin allergy,primary pneumothorax,     esophageal cancer, immune dysfunction, those who can not sign a consent form, and pregnant or     lactating, other serious concomitant illness such as uremia or liver cirrhosis. Study steps:     eligible Patients will randomize according to computer-generated random numbers, with 1:1     ratio in sequentially numbered, sealed envelopes by a study nurse who was masked to the     study. Randomization envelopes were opened, and randomization was performed by the study     nurse after informed consent was obtain. Eligible inpatients were randomized to the OK-432     group or the normal saline (NS) group，each group are 40 cases.      All subjects were observed by the physician who was masked to the study， about air leak stop     time, chest tube removal time, discharge time, outpatient chest X-ray, pulmonary function     tests as necessary. cases if persistent air leak more than seven days, the attending     physician determines whether pleurodesis again or surgery or other medical treatment.     Finally, the researcher who do not know groups will collection data by air leak case record     form including diagnosis, surgical site，the start and end time of the surgery, the use of     antibiotics, discomfort problems (pain , stomach discomfort, cough, fever> 38 ℃, allergic     reactions and respiratory discomfort), postoperative air leak time, air leak stop time ,     chest tube removal time, discharge time, the data will be use SPSS20.0 version of the     statistical software package, and T-test, pair T-test ，Anova ,linear correlation statistical     methods for analysis.      Outcome measures: OK-432 success rate, OK-432 side effects, air leak time, chest tube remove     time, length of hospital stay.   "
59821|NCT02502630|"     (MWA) is the most recent development in the field of local ablative therapies. The aim of     this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy     in pulmonary metastases from colorectal cancer.   "
59822|NCT02502617|"     In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are the     direct consequence of malnutrition and adaptation to starvation and which are not. There is     clinical consensus that depression/anxiety and cognitive impairments in AN mainly are     sequelae to the malnutrition. However, this consensus is largely based on experimental     starvation studies of healthy subjects back in 1940s and from famine- and food programs in     the third world, whereas evidence from studies on AN is lacking.      The main objective of the study is in the detail to elucidate the short-term changes in the     psychopathological profile, depression, anxiety, and cognitive functions in relations to     intensive nutritional rehabilitation with weight gain of 10-30% in a specialized medical     stabilization unit. Secondarily, it is examined whether cortisol levels are associated with     depression/anxiety symptomatology and cognitive impairments. The hypothesis is that an     improvement in nutritional status over a short time leads to clinically significant     improvements in psychopathology and cognitive functions, which remain 2-3 months after     discharge, making the patients more accessible to psychotherapy.   "
59823|NCT02502604|"     Individuals with affective disorders (including post-traumatic stress disorder (PTSD) and     major depressive disorder (MDD)) often experience declines in cognitive abilities such as     memory and attention. Such difficulties can reduce functioning in important aspects of life,     including at work or school. Little research has been conducted to investigate if cognitive     dysfunction can be reduced in individuals with PTSD or MDD following a specific treatment.     Thus, the investigators plan to determine the utility of a cognitive training program called     goal management training (GMT) in reducing cognitive dysfunction in MDD/PTSD. GMT aims to     assist participants in building skills in performing specific behaviours that rely on basic     cognitive processes, allowing them to achieve an identified goal. 64 individuals with PTSD     and 64 with MDD will be divided into two groups of 32, one GMT group, and one wait-list group     that will receive GMT after study completion. The investigators predict that in comparison to     the wait-list group, the GMT group will show greater improvements in cognitive functioning     and everyday functioning following treatment and that these improvements will remain     long-term.   "
59824|NCT02502591|"     Rectocoele or a posterior vaginal prolapse (bulge in the vagina) is a frequent gynaecological     condition. It is repaired by repairing and reinforcing the support to the vaginal wall at the     back. A small cut is made through the lining of the back wall of the vagina. The supports to     the rectum are reinforced with stitches and the bulging part of the vaginal wall cut away.     The wound in the vagina is then stitched up. Rectocoele repair is usually carried under a     general anaesthetic with women reporting moderate to severe degrees of pain post operatively     on sitting down.      A Pudendal Nerve Block (PNB) is a common analgesic (pain killing) technique often used for     women who need an instrumental delivery during childbirth. It is also widely used during a     range of surgical procedures (operations) as a preventive analgesia to help reducing post     -operative pain. The investigators would like to see if using this technique during routine     rectocele repair will help with post - op pain.   "
59825|NCT02502578|"     The purpose of this study is to assess the safety and to examine the index of the efficacy     after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit     cardiomyovasculopathy.   "
59840|NCT02502383|"     Using a previously created weight management program for adolescents, the intervention will     be implemented through school-based health centers (SBHC) and will be delivered by SBHC     providers trained in Motivational Interviewing. Students at intervention school sites will be     compared to students at control school sites. All students will have baseline, 1 year, and 2     year follow-up to assess if students in the intervention school sites will have improved risk     factor profile for metabolic syndrome, improved nutrition and increased physical activity     when compared with students at control school sites.   "
59864|NCT02501980|"     All participants in the selected communities will be tested for HBsAg by using serum samples.     Among those who are positive for HBsAg, further clinical work-ups including AFP test and     ultrasonography for liver exam will be performed. High risk group will be selected according     to the definition. HCC diagnosis will be determined according to imaging and/or biopsy     result. Repeated check-ups will be performed in 6-months among HBsAg positive group and     3-years among HBsAg negative group.      All subjects in the control arm (control communities) will be followed by record linkage to     Cancer Register and Population Register.   "
59827|NCT02502552|"     Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on     clinical factors (disease extension, perianal involvement, need for surgery, use of     immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic     role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have     been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil     cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the     distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and     their combined use has a sensitivity and a specificity of about 85%. However, 10 other     antibodies have been identified and recently evaluated individually in IBD and especially in     pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan     (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate     antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and     anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These     complementary tests improve the reliability of the diagnosis. In a previous cross-sectional     work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of     anti-glycan Abs and especially a correlation with a pejorative form of the disease both in     Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.   "
59828|NCT02502539|"     Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint     inflammation. The immune system disruption that leads to overproduction of pro-inflammatory     cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels—some molecular, some     cellular, and some systemic. Our objective is to identify the mechanisms through which     physical activity is liable to mediate inflammatory balance in autoimmune disease settings,     and specifically in JIA patients.   "
59829|NCT02502526|"     The purpose of this study is to demonstrate that the Centurion® Vision System used with the     45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti®     Vision System used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction     surgery via phacoemulsification of cataract grades NII- NIV [Lens opacities classification     system II (LOCSII)].   "
59830|NCT02502513|"     This pilot study aims to investigate the effects of a brief computerized intervention (the     computer game Tetris) on intrusive memories and other posttraumatic stress symptoms     following an emergency cesarean section. Patients who have undergone an emergency cesarian     section will be randomly allocated to either the brief computerized intervention or usual     care within the first 6 hours following the operation. Participants will be followed up at     one week and one month. It is predicted that participants given the brief computerized     intervention will develop fewer intrusive memories and less severe clinical symptoms than     those who are not. This will inform the potential future development of a simple computerized     intervention to prevent distressing psychological symptoms after a traumatic event such as an     emergency cesarean section.   "
59831|NCT02502500|"     To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when     administered alone and following multiple daily doses of AKB-6548.   "
59832|NCT02502487|"     This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in     men undergoing rigid cystoscopy.   "
59833|NCT02502474|"     Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and     colonic) of S. aureus in patients without chronic digestive disease who are going to have a     colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity     of strains isolated from each site will be analyzed using molecular tools. The aim of this     study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous     infections due to this bacterium.   "
59834|NCT02502461|"     Correct endotracheal tube (ETT) placement is important. Proper ETT position is achieved when     the distal tip is in mid-trachea with the head in neutral alignment. Unrecognized tube     misplacement is an uncommon but significant cause of hypoxemia and death during general     anesthesia as well as in the care of critically ill patients.      Hypotheses: A specific manoeuvre to palpate the inflated ETT cuff, with fingers anterior to     the trachea, moving the ETT caudally then rostrally following intubation, will enable correct     depth placement of the tip of the ETT within the trachea (more than 2.5cm above the carina     with cuff below the vocal cords) more frequently than routine care. This will not cause     tissue damage as measured by sore throat.   "
59835|NCT02502448|"     Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating     cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well     established.      Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly     allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced     hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.      After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are     analyzed.      As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be     determined at 10 min after ANH in Group-ANH and that at control.   "
59859|NCT02502045|"     Determine effect and duration of effect of timed therapeutic light compared to control light     on parameters of circadian rhythmicity, physiologic plasticity, sleep, and global function in     women with Alzheimer's Disease.   "
59836|NCT02502435|"     This study wishes to look at the 24-hour rhythm of certain fats in the blood stream. Recent     studies in animals and healthy participants suggest that unusual eating habits may be     connected to a change in the 24-hour rhythm of the blood fats the investigators wish to     measure. The investigators will ask persons suffering from night eating syndrome, a condition     where people eat additional meals throughout the night, to participate in this study. Healthy     volunteers who are of the same age and gender, and have a comparable body-mass-index, a     number calculated from a person's weight and height, will also be asked to participate.      The aim is to learn how the 24-hour rhythm of the blood fats the investigators measure     differs between the persons experiencing the night eating episodes and persons who do not.   "
59837|NCT02502422|"     Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord     paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway     cuff volume and pressure and physical examination of head and neck.   "
59848|NCT02502279|"     General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis.     Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve     arterial oxygenation.   "
66553|NCT02414581|"     Clinical triple-blind randomized controlled trial to assess the use of two different     mouthwashes to reduce the oral colonization by gramnegative bacteria in patients with     chemotherapy   "
59841|NCT02502370|"     The utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA)     remains unproven and awaits the results of a large, global, prospective, phase III,     randomised, controlled trial. Across the 830 million population of North America and Europe,     there are approximately 3,000 patients with stage I-III SBA every year who would be     potentially eligible for such an adjuvant chemotherapy trial.      Given the absence of good-quality and evidence-based data, it has been agreed that a trial     considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with     stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant     chemotherapy is uncertain. For those patients with stage I-III SBA who, with their     oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence     are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation     between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin     chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those     patients who do not consent to be randomised will be offered registration to allow collection     of demographic, clinicopathological and survival data, thereby making optimal use of the rare     patient population available. In addition, archival Formalin Fixed Paraffin Embedded (FFPE)     tissue and contemporaneous venous blood samples will be collected from every registered     patient to allow molecular profiling and future translational research. A questionnaire about     underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch syndrome etc) will be     completed along with the other collected data on all registered patients.   "
59842|NCT02502357|"     This is a randomized clinical trial comparing the severity of post-operative pain and use of     pain medication in women who are and are not exposed to healing statements before undergoing     vaginal hysterectomy with minimally invasive sacrocolpopexy. The investigators' hypothesis is     that those who are read healing statements before surgery will require less post-operative     pain medications and experience less severe pain than those who do not hear the statements.   "
59843|NCT02502344|"     This research would take medical interventions in subjects of insulin resistance without     abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose     tolerance in different groups.   "
59844|NCT02502331|"     -  Number of doses and intervals: Two doses, 2 weeks apart        -  Method of administration: Oral administration        -  Volume of vaccine to be administered: 1.5 mL/dose        -  Observational period: 4 weeks (2 weeks after each dose)        -  Number of visits: 3 visits             1. Visit 1: Screening and enrollment (1st dosing)             2. Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)             3. Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This               study will be carried out in healthy adults and children, at two sites, enrollment               will be competitive between the sites. Subjects will be stratified according to age               into adults (18~40 years of age) and children (1~17 years of age). According to the               pre-generated randomization list, the participants will be randomized to the test               or comparator groups (Visit 1) and will be given either the test vaccine or the               comparator vaccine. For immunogenicity assessment, blood sample will be taken at               Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the               end-of-study Visit (Visit 3). For Safety assessment: the participants will be               observed for 30 minutes post vaccination and instructed to record solicited adverse               events that occur up to 6 days after vaccination on the participant diary card.      This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two     distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine     administrator will remain blinded and will not handle the investigational product.   "
59845|NCT02502318|"     This is a national study that involves the participation of 600 lung cancer patients     indicated that treatment is ablation of the pulmonary lobe. This technique is called     lobectomy.      Lobectomy may be performed in two different ways:        -  Thoracotomy, which is the first reference approach and that is to make a large incision          in the chest to pass between the ribs and spread the order to ablate the lobe.        -  By video-thoracoscopy, which is a new surgical approach consisting in practice several          small incisions in the chest wall to allow the introduction of a camera and special          instruments to ablate the lobe.      The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative     expectoration and ventilation. As a result, the incidence of postoperative respiratory     complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS)     is reduced. These respiratory complications are responsible for prolonged stays in Intensive     Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of     life when patients return home. The reduction in the incidence of complications should     counterbalance the additional cost of video-thoracoscopy.      This study aims to evaluate the effectiveness of these two techniques in relation to the     quality of life and the costs they generate.      Patients who agree to participate in the study were assigned to one or other of these groups     (technical thoracotomy or video-thoracoscopy technique) by lot.   "
59846|NCT02502305|"     Aim of the study is to find out if the live online course is effective with regard to health     promotion. Older adults receive support to initiate a health behavior (i.e., to enhance     physical activity or to improve food habits).      Motivation, confidence and self-management strategies are optimized to make sure participants     are able to integrate the physical activity or healthy diet into their daily life.   "
59847|NCT02502292|"     In this study, the investigators evaluate an intervention aiming to increase participation     and communication of older adults during primary care consultations with their General     Practitioner(GP). The investigators are particularly interested in a Photo novel tool with     this aim. Photo novels are picture stories, which have the advantage of using a familiar     narrative format, thereby possibly increasing comprehension, personal involvement and     motivation and self-efficacy to perform the relevant behaviors by offering role models (story     characters that are similar to older adults themselves). The patient perspective on     doctor-patient communication is underrepresented in most research. This study aims to     incorporate the patient perspective in different ways: in addressing their needs and barriers     during focus group discussions, in collecting their communication strategies and solutions to     these barriers in the role play exercise, in involving them in developing the photo novel,     and in studying their responses to the photo novel in the evaluation study the investigators     describe in this research proposal.   "
59849|NCT02502266|"     This randomized phase II/III trial studies how well cediranib maleate and olaparib work when     given together or separately, and compares them to standard chemotherapy in treating patients     with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving     chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while     being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate     and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth.     Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It     is not yet known whether giving cediranib maleate and olaparib together may cause more damage     to cancer cells when compared to either drug alone or standard chemotherapy.   "
59850|NCT02502253|"     Mild Cognitive Impairment (MCI) represents a group of persons who are at risk of incident     dementia in the near-term. Persons with MCI who have deficits in short-term recall (amnestic     MCI) are at significant risk of incident Alzheimer's disease (AD) (termed prodromal AD), and     thus represent a worthy target for secondary prevention interventions.      There is increasing evidence that risk factors for metabolic syndrome (such as prediabetes     and type 2 diabetes) increase risk of incident cognitive impairment and possibly AD, and     evidence that the neurons of the AD brain are in fact insulin resistant with diminished     glucose uptake under physiological conditions. Thus, persons with MCI and prediabetes or type     2 diabetes may be at particular risk of incident cognitive impairment and AD.      A large clinical trial (ACCORD)1 demonstrated that tight control of peripheral blood glucose     does not improve cognitive (or other health) outcomes in older persons with peripheral     insulin resistance. Thus, there is a need to target cognitive outcomes in persons with MCI     and metabolic risk factors, and a drug targeting insulin resistance with good     blood-brain-barrier (BBB) penetrance can potentially accomplish these objectives. While there     is a phase III study of intranasal insulin targeting this strategy, nutraceuticals offer a     low-tech solution that would be more suitable to future secondary prevention trials in MCI.      Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical     preparations grape seed polyphenolic extract (GSE), and resveratrol that contain abundant     concentrations of polyphenols. The investigators have found that oral BDPP administration was     associated with improved cognition and brain plasticity long-term potentiation (LTP) in mouse     models of metabolic syndrome and AD, as well as lowering brain amyloid and tau burden in an     AD mouse model2-4. The investigators have demonstrated excellent absorption of oral BDPP in a     small study in humans and similarly excellent CSF penetration of oral BDPP in rats, but it is     crucial to demonstrate safety and CSF penetration of oral BDPP in humans to assess its     potential as a treatment for MCI and prediabetes or type 2 diabetes.   "
59851|NCT02502240|"     Evaluation of the frequency and clinical characteristics of ALK rearrangements in     Latin-American countries.      Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and     exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated     protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has     led to the development of novel therapies with activity in vitro and in the clinic.   "
59852|NCT02502227|"     This study is a three-arm randomized controlled trial of a mindfulness stress reduction     intervention, with the aim of dismantling the experience-monitoring and     nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment     component. In addition to enhancing understanding of mechanisms underlying the effects of     mindfulness interventions, identifying the therapeutic constituent(s) could inform     development of targeted interventions as well as provide strategies to optimize adherence.   "
59853|NCT02502214|"     Preimplantation Genetic Diagnosis (PGD) for monogenic diseases is usually performed by     multiplex PCR combining polymorphic microsatellites familial analysis and, where possible,     couple-specific mutation detection. Single-cell multiplex PCR developments are costly and     time-consuming. We propose to test and clinically validate a targeted next-generation     sequencing approach for the PGD for cystic fibrosis. This technique would allow a PGD for     probably almost every couple asking for it in our centre, without a previous couple-specific     development (but only a preliminary familial analysis). It will be based on haplotyping using     a large number of SNPs and mutation detection. A clinical validation will be performed by     reanalysing non-transferable embryos obtained after PGD for cystic fibrosis, with couple's     informed consent. Concordance of the results between PGD and reanalysis by NGS will be     achieved and if validated, this technique may be applied to future PGD for cystic fibrosis in     our centre. The same technique may then be applied for other PGD indications for which a     set-up is often needed.   "
59854|NCT02502110|"     The study will select all recruited patients with paroxysmal atrial fibrillation will be     randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before     ablation and last for 3 months. To observe the early relapse of atrial fibrillation and the     changes of white blood cell count, hs-C reactive protein (CRP), interleukin (IL)-6 and tumor     necrosis factor (TNF)-α, and the changes of safety indicators .      This study assumes that the early atrial fibrillation (AF) recurrence will be decreased in     patients with paroxysmal AF if rosuvastatin 20mg/d is received from 7 days before surgery in     these patients who plan to undergo radiofrequency catheter ablation for consecutive 3 months.   "
59855|NCT02502097|"     A randomized, double-blind, placebo-controlled, crossover, dose escalation study of     gefapixant (AF-219) in participants with Idiopathic Pulmonary Fibrosis (IPF) with persistent     cough.   "
59856|NCT02502084|"     3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to     visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the     sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic     procedures.   "
59861|NCT02502019|"     The primary objective of this pilot clinical investigation is to assess the reliability of     the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of     this clinical investigation are to collect initial data on the safety and efficacy of     HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.   "
59869|NCT02501915|"     The Kinesio Taping (KT ) method was developed more than thirty years ago in order to cause     sensory effects through the epidermis and dermis, generating a variety of physiological     effects in other systems. Clinical effects are well known levels in muscle, neurological     system, injuries, inflammation, edema, among other physiological effects are thus largely in     the theoretical framework. Objectives: The aim of this study is to evaluate the     Electromyographic (EMG), Electroencephalographic (EEG), muscle temperature and flexibility     effects with the Rectus Femoral muscle KT application. Methods: This is a pilot study with     six subjects in which they were divided into two groups, A and B. Group A received the     application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both     groups taped the non-dominant limb and the dominant limb was used as control group. The first     application was conducted at 0% and the second with 75 to 100% tension. Evaluations were     performed before the first application, immediately and 24 hours later. After this last     evaluation, was withdrawn taping, evaluated without taping, reapplied 75 to 100 % of rated     voltage and in sequence. The sixth last review was conducted 24 hours after this last     application. Before every application a specific vibration was performed on the patellar     tendon in order to trigger a neurophysiological imbalance rectus femoral.   "
59870|NCT02501902|"     This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety,     pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in     sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately     30-60 patients are expected to be enrolled in the overall study.   "
59871|NCT02501889|"     This study investigates whether walnuts help to promote weight loss, associated with     increased meal satiety and satisfaction, in 100 overweight and obese men and women who are     participating in a 6-month behavioral weight loss intervention. Participants will be randomly     assigned to a walnut-enriched reduced-calorie diet or a standard reduced-calorie diet. Body     weight, risk factors for cardiovascular disease, and self-reported feelings relevant to     satiety and appetite will be measured at baseline and 3- and 6-month follow-up. Also, the     response of gastrointestinal tract hormones following meals with or without walnuts will be     measured in a subset of study participants (n=20). Results from this study will contribute to     understanding the role of nuts in weight control, including further knowledge of the     mechanisms, and will expand knowledge of how nuts in the diet may contribute to the     prevention and management of obesity.   "
59872|NCT02501876|"     In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an     increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term     mild cognitive impairment (MCI) describes a transition state between normal cognitive     function and dementia. The annual rate of conversion to dementia in MCI patients is around     15% in the general population, regardless of the presence or absence of diabetes. At present     it is not possible to identify which patients with MCI are most likely to progress to AD. On     this basis, the main objective of this study is to evaluate whether the presence of diabetes     and or the presence of its related genes favors the conversion of MCI to AD.   "
59873|NCT02501863|"     The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with     ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.   "
59874|NCT02501850|"     Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general     population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective     treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of     CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to     lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have     demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp     (a) in hepatocytes. The objective of the study is to test in humans the results observed in     vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or     Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.   "
59875|NCT02501837|"     The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social     behavior and it has been recently shown that OXT also contributes to pair-bonding in men.     However, it is still elusive whether OXT has similar effects in women. In the present study,     the investigators examine the effect of intranasal OXT on behavioral ratings of and neural     responses to the male partner in female participants. In a second experiment, the modulatory     effect of OXT on emotion regulation is investigated.   "
59876|NCT02501824|"     Anthroposophic therapeutic speech is a complementary method that indirectly influences     breathing and uses specific vowels, consonants, syllables and metres depending on the     indication. The aim of this study is to test the effectiveness of anthroposophic therapeutic     speech in patients with asthma regarding clinical and physiological parameters, asthma     control and quality of life.   "
59877|NCT02501811|"     This is a phase II, randomized, placebo-controlled clinical trial designed to assess     feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells     (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared     to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by     transendocardial injection in subjects with ischemic cardiomyopathy.   "
59878|NCT02501798|"     This study aims at investigating the direct effects of methylphenidate on school performance     of primary school children. Although behavioral effects of this frequently prescribed drug     are thoroughly studied (and confirmed), the effects of methylphenidate on school performance     are less clear. Recent overviews indicate that effects are mainly quantitative and     subject-specific. To gain more insight in this issue, the current double blind placebo     controlled crossover study investigates not only the effects of methylphenidate on school     performance but also it's effect on related variables such as short term memory, motivation     and behavior. 60 children with ADHD are included and tested twice (with medication and with     placebo) at their primary school.   "
62707|NCT02464852|"     The aim of this study is to evaluate the effects on MND patients of a new collar specifically     designed for people affected by neck weakness: the Sheffield Support Snood.   "
59879|NCT02501785|"     The purpose of this study is to understand the level of caregiver burden related to caring     for a patient who goes home within the first 24 hours following surgery. As the caregiver     they are providing care to a family member, friend, or neighbor. Even when not formally     trained, the care they provide is important to the patient's recovery. Providing care in this     manner can be stressful. This study will help us understand what aspects of the patient's     recovery are most difficult for the caregiver.   "
59881|NCT02501759|"     This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy     to see how well it works in identifying cancer in patients with suspected prostate cancer who     are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle     inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI.     MRI uses magnets to take pictures of the prostate and may be able to identify cancer.     Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard     ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more     effective than ultrasound-guided biopsy in identifying prostate cancer.   "
59882|NCT02501746|"     Specific Aims: Bridging Income Generation with GrouP Integrated Care (BIGPIC) Over 80% of     cardiovascular disease (CVD) deaths occur in low- and middle-income countries (LMICs).     Diabetes, a major risk factor for CVD, is also responsible for substantial morbidity and     mortality in LMICs. Elevated blood pressure (BP) increases CVD risk among individuals with     diabetes and pre-diabetes; BP control is therefore a powerful way to reduce CVD risk.     Cost-effective, culturally appropriate, and context-specific approaches are critical. Two     promising strategies to improve health outcomes are group medical visits and microfinance.     Both can increase quality of care, clinician-patient trust, self-efficacy, health savings,     self-confidence, group cohesion, and social support. While these strategies have been     successful in other contexts, their impact on CVD risk reduction among diabetics and     pre-diabetics in low-resource settings is not known.      In partnership with the Government of Kenya, the Academic Model Providing Access to     Healthcare (AMPATH) Partnership has expanded its clinical scope of work to include diabetes     and hypertension. AMPATH has piloted group care and microfinance initiatives among patients     with chronic diseases with promising early results. Both strategies are feasible, as is     integration of group medical visits into microfinance groups. However, the effectiveness of     these strategies individually, and in combination, on improving CVD risk is not known.      Thus, the objective of this proposal is to utilize a transdisciplinary implementation     research approach to address the challenge of reducing CVD risk in low-resource settings. The     central hypothesis is: group medical visits integrated into microfinance groups will be     effective and cost-effective in reducing CVD risk among individuals with diabetes and at     increased risk for diabetes in western Kenya, and that the key modifiable CVD risk factor to     be addressed is BP. The research team hypothesize that group medical visits and microfinance     may each reduce CVD risk, but the integration of group medical visits and microfinance will     yield the largest gains. Also further hypothesize is that changes in social network     characteristics may mediate the impact of interventions on the primary outcome, and that     baseline social network characteristics may moderate the impact of interventions. To test     these hypotheses and achieve the overall objectives, the following specific aims will be     pursued:      Aim 1: Identify the contextual factors, facilitators, and barriers that may impact     integration of group medical visits and microfinance for CVD risk reduction, using a     combination of qualitative research methods: 1) baraza (traditional community gathering) form     of inquiry; and 2) focus group discussions among individuals with diabetes or at increased     risk for diabetes, microfinance group members, and rural health workers.      Subsidiary Aim 1.1: Use identified facilitators and barriers to develop a contextually and     culturally appropriate integrated group medical visit-microfinance model to reduce CVD risk     among individuals with diabetes or at increased risk of diabetes. This model's acceptability     and feasibility will be assessed by conducting focus group discussions with patients,     microfinance group members, and health workers.      Aim 2: Evaluate the effectiveness of group medical visits and microfinance groups for CVD     risk reduction among individuals with diabetes or at increased risk for diabetes, by     conducting a four-arm cluster randomized trial comparing: 1) usual clinical care; 2) usual     clinical care plus microfinance groups only; 3) group medical visits only (no microfinance);     and 4) group medical visits integrated into microfinance groups. The primary outcome measure     will be one-year change in systolic blood pressure (SBP), and a key secondary outcome will be     change in QRISK2 CVD risk score, which has been validated for Black Africans.      Subsidiary Aim 2.1: Conduct mediation analysis to evaluate the influence of changes in social     network characteristics on intermediate factors and intervention outcomes and moderation     analysis to evaluate the influence of baseline social network characteristics on     effectiveness of interventions.      Aim 3: Evaluate the incremental cost-effectiveness of each intervention arm of the trial, in     terms of costs per unit decrease in SBP, per percent change in CVD risk score, and per     disability-adjusted life year saved.      This research project will add to the existing knowledge base on innovative, scalable, and     sustainable strategies for reducing CVD risk in diabetes and other chronic diseases in LMICs     and other low-resource settings. If proven to be effective, the investigators are poised to     expand the approach beyond the trial, thus ensuring that this research will have a     significant and positive health impact on a larger population.   "
59883|NCT02501733|"     This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta     GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data     coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num:     20141994) and randomized to the Sphere arm, will have their data utilized for this study.   "
59884|NCT02501720|"     Post burn flexion contractures are common in pediatric age group. Release of contracture and     coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem.     This procedure is routinely done under tourniquet control because bloodless operative field     is essential to visualize important neurovascular structures in hand.      Use of tumescent technique without a tourniquet is gaining acceptance because it avoids     complications associated with tourniquet use, maintains a blood less surgical field and     decreases operative time. Furthermore use of tumescent anesthesia often results in better     surgical outcomes.      Although the benefits of tumescent technique used in wide awake hand surgery are well     documented, epinephrine at a concentration of 1:1 000,00 has also been used as a replacement     for pneumatic tourniquet for release of hand contracture in infants and adults under general     anesthesia. Thus epinephrine 1:1,000,00 in saline solution can be a potential replacement for     a tourniquet in hand surgeries done under general anesthesia.   "
59885|NCT02501707|"     Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer     patients, who are treated with curative chemoradiation. In this study the investigators want     to evaluate the prognostic value of baseline cardiac function assessed with echocardiography     for prediction of RILI.   "
59886|NCT02501694|"     Define responses to exercise on both arterial bruits and oxymetry in patients referred for     suspected endofibrosis.   "
59887|NCT02501681|"     Single-centre prospective randomized study will be included the patients who undergo elective     cardiovascular surgery. Preoperative fluid deficit will be calculated by the formula as     starvation period X 4 X weight. Patients will be divided into two groups: Group A (n=20);     crystalloid as priming solution used in patients, Group B (n=20); colloids as priming     solution used in patients. In addition to priming solutions, extracorporeal pump will be     filled with 150 mL of Mannitol, 60 mL of NaHCO3 and 10000 IU Insulin. Standard anesthesia     protocol will be administered to all patients. Ringer's Lactate will be given at first 30     minute after induction. Ringer's Lactate as fluid maintenance will be administered at a rate     of 100 mL/h except in extracorporeal circulation. Goal-directed fluid management will be     performed by PVI (Pleth Variability Index). Cut off level of PVI will be accepted %15.   "
59888|NCT02501668|"     The investigators will evaluate the prevalence of lung cancer associated with interstitial     lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health     Insurance Review and Assessment Service (HIRA) database, spanning the period from January     2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of     outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD),     and COPD were identified based on the International Classification of Disease-10 (ICD-10)     diagnostic codes.   "
59889|NCT02501655|"     BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose     compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to     compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar     scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled     99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN     (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb     Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine     distribution of deposition and mass balance between compartments.   "
59890|NCT02501642|"     The proposed study will address a very important issue for the VA both currently and in the     future -- the high percentage of OIF/OEF/OND Veterans who have been medically diagnosed with     a mild traumatic brain injury (mild TBI) and experience distressing symptoms. Smart phone     mobile applications have become a primary source of information and communication among large     percentages of Americans, especially those of the OIF/OEF/OND generation. The proposed study     is a 4-year randomized control trial investigating the utility of an interactive,     self-management smartphone application, TBI Coach, one of a suite of mobile applications     developed by VA. The primary goal of the proposed study is to evaluate the efficacy of TBI     Coach for improving clinical outcomes in those with a history of mild TBI and to determine     what aspects of TBI Coach are most useful to Veterans. An overarching goal of this line of     research is to improve access among Veterans with mild TBI who still have symptoms months to     years after injury.      Objectives. The study will pursue the following objectives:        1. Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of          TBI Coach.        2. Determine the aspects of TBI Coach most associated with positive outcomes.        3. Obtain qualitative information on factors associated with use of TBI coach or with          deriving benefit from use of TBI Coach that can be used to inform future modifications          of the application and wide scale implementation.   "
59891|NCT02501629|"     The primary objective of the study is to determine the ability of reslizumab administered sc     to produce a corticosteroid-sparing effect in patients with oral corticosteroid     (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.   "
59892|NCT02501616|"     This is a phase 4, single center, randomized, open-labeled, cross-over design study. The     primary objective of the study is to compare effect of dapagliflozine and metformin on     endothelial function.      Subjects are randomized to initial metformin or initial dapagliflozin group and maintained     initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained     10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8     weeks' cross-over is followed.   "
59893|NCT02501603|"     For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is     a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks     signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the     transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of     afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer     patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for     target enriched patients in gastric cancer.   "
59894|NCT02501590|"     Drawing on a vertical surface, such as a blackboard (rather than a horizontal surface) is     often used by occupational therapists as a way of developing fine motor control and visual     motor integration in children. While there is anecdotal evidence to support this     intervention, preliminary results in healthy children showed no differences in graphical     quality while drawing on vertical or horizontal surfaces. This however was not investigated     in children with graphomotor impairments.      The goal of this study is to determine whether movements produced on a vertical surface     differ in their performance level and muscle activation patterns compared to movements     produced on a horizontal surface. The investigators predict that the level of performance on     the vertical surface will exceed the level of performance on the horizontal surface.     Additionally, the investigators hypothesize that the proximal muscles will be more activated     and fatigued (in longer tasks) while drawing on the vertical surface, while the distal muscle     will be more activated and fatigued while drawing on the horizontal surface.   "
59895|NCT02501577|"     Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position   "
59896|NCT02501564|"     Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and     low efficacy. The investigators aimed to evaluate efficacy and safety of naproxen     sodium/codeine phosphate combination in these patients.   "
59897|NCT02501551|"     This is a phase II trial of regorafenib in patients with metastatic melanoma harboring c-Kit     mutations and/or amplifications of c-Kit gene copy number. The primary end point is disease     control rate (DCR), and the secondary end points are safety, response rate (RR), progression     free survival (PFS), and overall survival (OS).   "
59898|NCT02501538|"     This is a pilot study. The investigators plan a cohort study of 10 patients with a diabetic     foot ulcer (DFU). Study duration will be three weeks. Patients will be consented and undergo     debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory     Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue     samples will be taken at this visit during standard of care wound debridement and these     tissue samples of the wound would normally be removed as part of routine debridement. These     tissue samples of the wound will be used for gene expression and bacterial     analysis(research). The patient will then receive topical oxygen therapy using the TransCu O2     device (research) with moist wound dressings for 21 days. Moist wound dressings are used as     standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after     routine wound debridement, and patient will receive instructions for home use of the device.     The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study     window of 5 days., Digital photos of the wound, acetate tracing of the wound and vascular     evaluations(SensiLase, Transcutaneous oxygen measurements, Hyperspectral imaging) will be     performed at each study visit(research).Tissue samples will be taken during standard of care     wound debridement at every study visit. Results of the data analysis from this project will     be used to inform the design of a larger randomized clinical trial.   "
59899|NCT02501525|"     This study will include patients aged between 18 and 70 who will undergo retrograde     intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will     be recruited, and will be randomized into 2 groups consisting of 40 patients in each group.     The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned     prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases     the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or     not affects the level of pain felt by patients in the postoperative period.   "
59900|NCT02501512|"     This study aims to extract and discriminate the signals of respiration, heart rate and     swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric tube.     These signals will be compared with the standard monitoring signals in the neonatal intensive     care unit (NICU). Further, they will be used to search for objectively quantifiable     maturational coordination processes of respiration, heart rate and swallowing. Lastly, this     study aims to identify changes in ECG/EMG-signals as a result of external stimuli (e.g.     nursing interventions) in the NICU.   "
59909|NCT02501395|"     Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive     muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms,     followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and     bulbar muscles are also involved. However, the muscle involvement pattern has not been     investigated systemically in Kennedy disease.      The primary aim of the study is to investigate the muscle involvement in patients with     Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as     a potential outcome measure for future clinical trials in Kennedy disease.      Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy     voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5     hours.   "
59910|NCT02501382|"     The purpose of this study is to investigate the effects of hyperic oxygen treatment on the     immune response in patients with necrotizing soft tissue infections   "
59948|NCT02500888|"     The aim of this study is to evaluate, through a pilot study with about ten cases, if     bilateral ventral capsulotomy by linear accelerator enable modification of     obsessive-compulsive symptoms and quality of life in patients with severe and refractory     obsessive compulsive disorder (OCD) and also investigate possible adverse effects /     complications of the procedure.   "
59901|NCT02501499|"     This is an exploratory, qualitative evaluation study of the Breastfeeding Buddies (BFB)     program. The Breastfeeding Buddies Program is a peer-based education and support program     offered through the Kitchener Downtown Community Health Centre. The KDCHC has received     funding to undertake a qualitative exploratory study of the BFB program. KDCHC has partnered     with researchers at the Manulife Centre for Community Health Research at Wilfrid Laurier     University to plan and implement this study.      The purpose of the evaluation study is to understand the perspectives and experiences of     Breastfeeding Buddies (BFB) participants and volunteers. The evaluation will explore the     process of implementation of the BFB education and support programs and assess the program     impacts from the perspective of participants and volunteers. The methods in this study are     qualitative because the BFB program has never collected qualitative data from program     participants and volunteers. In the past, evaluation of the program has been limited to pre     and post surveys. This qualitative study includes two components:        1. Interviews 6-8 weeks after the participants due dates with consenting mothers who          participated in the Me Breastfeed workshop - 10-12 mothers who were matched with a Buddy          (optional for all workshop participants) will be interviewed and 10-12 mothers who did          not seek a match (but did participate in the workshop) will be interviewed to explore          what they learned, what was helpful and how the program can be improved.        2. One focus group with 10-15 Breastfeeding Buddies volunteers to explore the experiences          and perspectives of the BFB volunteers.   "
60122|NCT02498626|"     This study was designed to examine if venous saturations from the central venous line and     from the venous side of the heart lung machine are interchangeable or not with mixed venous     saturation from the pulmonary artery in children undergoing open heart surgery for correction     of various congenital heart defects.   "
59902|NCT02501486|"     Rationale: Case reports describe suppression of the hypothalamic-pituitary-adrenal (HPA) axis     caused by local corticosteroids, most often with inhalation corticosteroids. The exact     prevalence is not known. Early recognition is important, because suppression of the HPA-axis     can lead to significant morbidity and mortality. Suppression of the HPA axis might occur more     often when a Cytochrome P450 3A4 (CYP3A4) inhibitor, e.g. ritonavir, is used next to the     local corticosteroid, a combination often used by human immunodeficiency virus     (HIV)-patients. Cortisol can be determined in hair. This non-invasive analysis could help in     diagnosis of suppressed HPA-axis.      Research questions:      Primary objective:        1. How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis in          HIV-treated patients?           Secondary objectives:        2. Are other variables associated with the HPA-axis suppression?        3. Are cortisol measurements in hair as reliable as serum cortisol or an          Adrenocorticotropic hormone (ACTH) stimulation test to diagnose suppression of the HPA          axis? Study design: cross-sectional explorative study Study population: adults treated          for HIV and using an inhalation or nasal corticosteroid.      Intervention: an ACTH stimulation test, cortisol measurements in blood and hair.      Main study parameters/endpoints:      Proportions of persons with a low morning plasma cortisol or low cortisol after an ACTH     stimulation test. Correlation between cortisol in plasma and hair cortisol.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Each person will be screened with a history and a short physical examination. A     venous cannula will be inserted for obtaining blood for the plasma cortisol and for the ACTH     stimulation test. An ACTH stimulation test has no major complications. A piece of hair is cut     for cortisol hair analysis. The risks and burden are minimal, while the future benefits could     be great since suppression of the endogenous HPA- axis can be associated with morbidities     like hypertension or osteoporosis and can even lead to an adrenal crisis when the local     corticosteroid is stopped.   "
59903|NCT02501473|"     This is a Phase 1/2 open label trial of G100 in patients with low grade NHL. G100 is composed     of glucopranosyl lipid A in a stable emulsion and is a potent TLR4 (toll-like receptor-4)     agonist. G100 will be administered by direct injection (intratumorally) into tumors of low     grade NHL following standard low dose radiation therapy. Preclinical models and clinical     studies in other cancers such as Merkel cell carcinoma have demonstrated that G100     administered in this manner can alter the tumor microenvironment, activate dendritic cells, T     cells and other immune cells and induce systemic anti-tumor immune responses. In this trial,     the safety, immunogenicity, and clinical efficacy of G100 will be examined alone or with     pembrolizumab.   "
59904|NCT02501460|"     This study is being conducted because low lean muscle mass is prevalent among childhood     cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the body's     lean body mass. Low lean muscle mass is associated with loss of overall body strength,     declining mobility and eventually, loss of independence. Among childhood cancer survivors,     low lean muscle mass may contribute to reduced physical functioning and a sense of fatigue     with exertion, limiting ability to participate in adequate physical activity. Loss of     strength and a sense of fatigue with repeated movement make it difficult to participate in     daily activities.      Although there have not been exercise intervention studies among childhood cancer survivors     specifically designed to evaluate the effects of resistance training on muscle mass, studies     among individuals with chronic disease, including survivors of adult onset cancers, indicate     that resistance exercise improves muscle mass, muscle strength, mobility, vitality and     physical activity levels. Resistance training (weight lifting) is a form of physical activity     that is designed to improve muscular fitness by exercising a muscle or a muscle group against     external resistance.      The purpose of the study is to evaluate the effects of resistance training combined with     either a protein supplement or a sports drink on changes in lean muscle mass in young adults     who were treated for childhood cancer. The sports drink, for this study, is considered a     placebo.   "
59905|NCT02501447|"     Stress is known to trigger acute pain crisis of sickle cell disease (SCD). SCD is an     inherited blood disorder that afflicts about 100,000 people in the United States, and is     among the most common lethal genetic diseases in the United States. Though worldwide in     distribution, in the US it is most commonly found in African Americans. Its best known     complication is severe, recurrent relentless pain, often known as pain crisis. Non-drug     treatment for SCD pain such as cognitive coping interventions have been shown to be effective     for reducing SCD pain intensity, but they are complicated, multifaceted, and time-consuming.     A simple and cost-effective alternative such as guided imagery (GI) could reduce the effect     of stress on SCD pain. GI is an intervention where patients listen to and view audio-visual     recordings while being directed to visualize themselves being immersed in that scene or     scenario. There are no published studies on the use of GI as a simple stress coping     intervention or tracking stress in a systematic manner as a trigger for SCD pain.   "
59906|NCT02501434|"     A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose     Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients     with Significant Hemorrhage Burden.   "
59907|NCT02501421|"     The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial     that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L     tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged     18-50 years.   "
59921|NCT02501239|"     The primary aim of this project is to conduct a randomized controlled pilot study evaluating     the feasibility and potential effectiveness of a newly developed combined Health At Every     Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself!     compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women     (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two     treatments. Depression, physical health, and other psychosocial outcomes will be assessed     prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.   "
83155|NCT02197559|"     The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis     than Bare-metal stents after Vertebral Artery Ostium stenting   "
59911|NCT02501369|"     Cystic fibrosis (CF) is an illness that makes the lungs clog up with sticky mucus. There is     no cure and so treatments are used to help make the illness easier to live with. The     treatment can take lots of time and can feel not very nice sometimes. When children with CF     become teenagers they need to learn to take charge of their treatment. This can be difficult.     Teenagers with CF want to fit in with friends and can become more upset about their illness.     Their parents have to learn to let their child take charge of their illness which can be hard     for parents. These issues can put strain on parent-child relationships and this can make it     harder for teenagers to stick to their treatment plans. A parenting program (called Teen     Triple P) has been shown to help teenagers with other illnesses (such as diabetes) to be able     to stick to their treatment plans. Parents are given a booklet to work through at home which     helps them to build on the skills they already have. It aims to help families to support     positive parent-child relationships, to manage difficult teenage behaviours, and to teach new     skills and behaviours. So far no one has done any research to see if this program helps     families of teenagers with CF. This research would like to see if the Triple P program can     help teenagers with CF stick to their treatment plan. Helping teenagers stick to their     treatment plan will help them to live happier and healthier lives.   "
59912|NCT02501356|"     To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the     primary outcome measure of body weight and secondary outcome measures (hunger/satiety,     health-related measures and self-reported quality of life) in a group of overweight but     otherwise healthy adults.   "
59913|NCT02501343|"     The purpose of this study is to test the effect of increasing the body pH acutely with an     alkaline medication (sodium bicarbonate, NaHCO3, sodibic) on glucose metabolism post meal in     non diabetic subjects with normal renal function.      The investigators aim to determine whether there is an acute reduction in venous blood pH     following a typical Western-style (high acid load) breakfast in healthy men and women, and     whether this effect is attenuated by the concurrent administration of an alkaline medication.     The effect on glucose metabolism, hunger/satiety and arterial stiffness post meal will be     assessed.   "
59914|NCT02501330|"     The objective of this surveillance is to collect information about        1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)        2. the incidence of adverse drug reactions in this surveillance        3. factors considered to affect the safety and/or efficacy of this drug.   "
59915|NCT02501317|"     Introduction: Urinary incontinence is a condition that affects most women in her adult life;     it is considered a public health problem and has a high negative impact on the quality of     life. Physical therapy is considered as the first treatment option for this disease, these     treatments are done with pelvic floor muscles exercises (kinesiotherapy) with or without the     use of other resources such as biofeedback, electrical stimulation and vaginal cones.     Rationale: The protocols used in the various studies on the treatment of urinary incontinence     are made with only one type of therapy and have no change in the intensity of the exercises.     The Active Perineal Rehabilitation protocol uses kinesiotherapy with biofeedback,     electrical stimulation, vaginal cones and home exercises; it consists of 14 individual     sessions that gradually evolve the intensity of exercises. Objective: To assess the     scientific validity of Active Perineal Rehabilitation protocol for the treatment of urinary     incontinence. Methodology: A multicenter, prospective clinical trial, controlled and     randomized, the sample will be divided into a study group that will be treated with the     Active Perineal Rehabilitation protocol, and a control group will be treated with the     protocol already widely used.      Keys Words: urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum,     conservative treatment   "
59916|NCT02501304|"     This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and     effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.   "
59917|NCT02501291|"     Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by     relapse and progression. The incidence and prevalence of IBD are increasing in different     regions around the world, indicating its emergence as a global disease. Though modern medical     therapies including immunomodulators and biologic agents have revolutionized treatment of CD,     the occurrence of steroids-dependence and resistance or intolerance to medical therapy is     quite common. The limitation of present therapeutic management and the high expense of     biologic agents leads to the treatment of CD become refractoriness. The occurrence rate of     steroids-dependence and resistance or intolerance to thiopurine therapy is quite high during     the course of CD. Approximately 38% of cases required surgery within 10 years. Therefore, the     management of such refractory CD remains a great therapeutic challenge for clinicians.      Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor necrosis     factor)-a- suppressing effects. The potential role for thalidomide in the treatment of     refractory paediatric and adult CD has been investigated in more and more small open-label     studies and retrospective case series. Recently, a randomized controlled trial showed     thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance     of remission in pediatric refractory CD. Gerich et al reported in a retrospective study that     thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a     median of 58 months. However, the dose of thalidomide used in these studies ranged from     50mg/d to 150mg/d, and the occurrence rate of side effects reported variously but all quite     high. The side effects related to the dose of thalidomide were the major concerns of using it     in CD. Moreover, the effect of thalidomide on endoscopic response including mucosal healing     which is a more objective and important outcome in CD was rarely reported. Therefore the aim     of this study is to investigate the efficacy on clinical and endoscopic response and the     adverse effects of using low-dose thalidomide in active adult CD patients.   "
59932|NCT02501096|"     This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in     participants with selected solid tumors. Phase 1b will determine and confirm the maximum     tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous     [IV], every 3 weeks [Q3W]) pembrolizumab in participants with selected solid tumors (i.e.     non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial     carcinoma, squamous cell carcinoma of the head and neck, or melanoma). Phase 2 (Expansion)     will evaluate the safety and efficacy of the combination in 6 cohorts at the MTD from Phase     1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).   "
59918|NCT02501278|"     The aim of this study is to assess the potential benefit of the addition of immunotherapy     with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and     continued as adjuvant in patients with locally advanced cervical cancer.      Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This     safety run-in phase will include the first 3 patients treated in each of the two INO-3112     combination arms who are exposed to at least two immunotherapy doses and evaluate whether the     combination does not pose undue immediate risks to the patients further enrolled in the     trial.      Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant a     further phase III conclusive trial based on progression free survival (PFS) at 18 months     assessed by RECIST by the local investigator. The efficacy will be assessed within each     experimental arm while the standard arm will serve as a reference arm to check the     reliability of the results.   "
59919|NCT02501265|"     This study is designed to test an adaptive pharmacotherapy algorithm within the Duke Smoking     Cessation Program (DSCP). The investigators hypothesize that patients treated in the DSCP     with Algorithm-based pharmacotherapy vs. Varenicline will show significantly higher 12-week     post-quit 30-day continuous abstinence.   "
59920|NCT02501252|"     Rationale: Every year, 287,00 million women, and 3.1 million neonates continue to die, and     the majority of these deaths have been identified as being avoidable. A proxy indicator of     Millennium Development Goal (MDG) 5, birth with skilled attendance is low in Sub-Saharan     Africa(47%) and the lowest (13%) is for Ethiopia, with the greatest number of maternal     deaths. The Ethiopia health system has established a vast network of health infrastructure     that extends to rural areas with the establishment of over 15,000 health posts and deployment     of over 30,000 health extension workers throughout the country. Although these unprecedented     situations made health services more accessible than ever, it is yet to be exploited for     improving rural women's access to clean and safe delivery and postpartum care. Lack of usage     of delivery care in the country is related not only to accessibility but also acceptability     of the services. In fact, the vast majority of women with home deliveries saw institutional     delivery as unnecessary and a non-customary practice. Therefore, instituting an     innovative, culturally sensitive, and practically amenable strategy, deployment of CORNs for     example might be the best remedy, in this case.      Objective: To evaluate the effectiveness and acceptability of availing Home based Skilled     Birth Attendance (SBA) Services through Community Reproductive Health Nurses (CORN) in rural     communities of Ethiopia.      Study design: Cluster Randomized Controlled Community Trial that will be conducted in four     phases.      Study population: Study participants will be all pregnant women who will give birth at home     and health facility (including health post) during the study period.      Intervention: The study will be conducted in four phases as discussed below. During the first     (preparatory) phase, sensitization of relevant stakeholders and recruitment of trainees will     be conducted. In the second phase, formative and baseline assessment as well as training of     CORNs will take place. In the third phase, which will be actual intervention phase,     deployment of CORNs in their respective study site will be done and in the final phase, final     evaluation and dissemination of study findings will be done. The intension behind deploying     CORNs to the grassroots level is just to give a backup skilled delivery and other MNH     services to poor rural mothers who have difficult of accessing modern health facilities for     various reasons; it has no any intention to promote or encourage home deliveries or replace     institutional deliveries. Perhaps it will help to assimilate rural mothers to modern health     facilities Main study parameters/endpoints: The main study end point is percentage of skilled     birth attendance which is very low in local and national level. In addition secondary study     parameters are percentage changes of maternal & related services uptakes. These include     focused Antenatal; care (ANC), long term family planning, Prevention of Mother to Child     Transmission of HIV (PMTCT) and postnatal care.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: the burden and risks associated with participation to the study is very minimal.     To mention few; physical examinations (Leopold manoeuvre) or the routine investigations of     pregnancy this will be anonymous except for the CORNs keeping the principles of shared     confidentiality in mind. Similarly all questionnaires or medical charts will be kept     confidential. All CORNs will obtain intensive training on ethical principles that will help     to minimize any physical and physiological discomfort associated with participation, the     risks associated with the investigation treatment.      The study period and Budget: the study will be carried out in a total of 18 months which     holds a period from the development of protocol to the terminal evaluation and submission of     reports. The overall study budget will be 99, 987.95 USD (Ninety nine thousands, nine hundred     eighty seven dollars and ninety five cents   "
59922|NCT02501226|"     Background. Major Depressive Disorder (MDD) is highly prevalent and was associated with     greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will     become the leading cause of disability in high-income countries. Notably, among patients with     a previous experience of a major depressive episode, it was indeed estimated that up to 85%     of those patients will suffer from relapse. Two main factors were associated with a     significantly higher risk of relapse: poor medication adherence and low self-efficacy in     disease management. Interestingly, these issues could become the targets of psychoeducational     programs for chronic diseases. Inded psychoeducational program for depression are recommended     in international guidelines, but have not yet been proposed in France.      Methods/Design: The investigators propose to evaluate the first French psychoeducational     program for depression named ENVIE in a multicenter randomized controlled trial. Its aim is     to educate patients on the latest knowledge on depression and effective treatments through     didactic and interactive sessions. Patients will experiment the latest innovating     psychological skills (from acceptance and commitment therapy) to cope with depressive     symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic     (< 2 years) outpatients with moderate to severe depression, without psychotic features, will     be randomly allocated to the add-on ENVIE program (N=166) or to a waiting list (N=166). The     follow-up will last 15 months and include 5 assessment visits (enrollment, 3, 6, 9, 12, 15     months).      Discussion. If the proposed trial shows the effectiveness of the intervention, but also an     increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to     improved treatment adherence in patients, it will further promotes arguments in favor of a     wide dissemination of psychoeducational programs for depression.   "
59923|NCT02501213|"     While some authors recommend diuretics as the first treatment to initiate for symptoms caused     by malignant ascites (MA), their prescription is variable. No randomized, controlled study     has assessed their benefit in this context. According to literature, diuretics may bring     relief in about 40% of cases, regardless of primary tumor.      The purpose of our study is to assess the effectiveness of diuretic treatment according to     Serum Ascites Albumin Gradient (SAAG) measured before treatment. Judgment criteria is the     time elapsed between recurrent MA that requires paracentesis. The investigators will also     examine whether SAAG and serum levels of renin and aldosterone can predict symptom response     to diuretics.   "
59924|NCT02501200|"     A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety     CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.   "
59925|NCT02501187|"     Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired.     Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the     levator aponeurosis. Treatment is surgical and can be performed by three common procedures -     Levator advancement, Müller's muscle-conjunctival resection procedure and White line     advancement. A number of reports inspected the possibility that Blepharoptosis repair     procedures may cause deterioration in dry eye status. The investigators would like to assess     whether there is a difference between the different procedures in their influence on dry eye     status.   "
59926|NCT02501174|"     The aim of this study is to establish a common geriatric oncology medical database. The     patients concerned are the patients having benefited from a geriatric oncology consultation     in one of the participating centres. This database is designed with a view on the one hand to     better describe to better understand this population and on the other hand to facilitate the     conduct of future retrospective or prospective studies on this population. The constitution     of this observatory of patients seen in consultation should facilitate the development of     studies from the analysis of data collected, and occasional surveys by the rapid     identification of cases. Data from this database could provide clinicians with valuable     informative elements of descriptive epidemiology and concerning the organization of care in     the geriatric oncology field.   "
59927|NCT02501161|"     This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose     is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus     insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately     controlled with oral anti diabetics.   "
59928|NCT02501148|"     The purpose of this study is to assess the safety and clinical performance of Paladin System     in patients with carotid artery stenosis.   "
59929|NCT02501135|"     The purpose of this study is to retrospectively compare perioperative pain relief and safety     in pediatric patients who have received a femoral nerve block with varying concentrations of     local anesthetic.   "
59930|NCT02501122|"     The purpose of this study is to interrogate the Partners for Kids (PFK) and the pediatric     health information (PHIS) databases in addition to our own perioperative Nationwide     Children's data base to look at outcomes, resource utilization, and cost trends for     adenotonsillectomy in the nationally versus locally. The investigators also want compare     Nationwide Children's to other regional and national tertiary pediatric institutions.   "
59931|NCT02501109|"     The purpose of this study is to compare the rate and extent of absorption of Aripiprazole     Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male     volunteers   "
59933|NCT02501083|"     Muscular dystrophies are inherited disorders that affect skeletal muscle. Cardiac and     respiratory function may be affected in this group of diseases. The investigators sought to     analyze the long term cardiac and respiratory function in patients with muscular dystrophies     recquiring home mechnaical ventilation .   "
59934|NCT02501070|"     This is a multicenter retrospective observational study with STEMI (ST Elevation Myocardial     Infarction) patients who have been treated in the northern Galician Hospitals. The study     tries to verify if the implantation of the PROGALIAM (Galician Assistance Program Acute     Myocardial Infarction) has supposed a progress in the quality and expectancy of life of AMI     patients in the north area of Galicia.      The study will recruit STEMI patients according to the third consensus definition of     myocardial infarction type I.      It will include all patients who meet these criteria regardless of other demographic or     clinical circumstances. There is not exclusion criteria defined for this population.   "
59950|NCT02500862|"     Characterize potential biomarkers of sight-threatening eye diseases based on the information     acquired in clinical practice at CEC, AIBILI   "
59935|NCT02501057|"     The purpose of this study is to compare the effects of interventions for drinking-reduction     and antiretroviral therapy (ART) adherence among HIV-positive primary care patients. The     interventions consist of brief meetings to discuss drinking and ART adherence enhanced with     daily self-monitoring through the use of a smart phone application that tracks drinking and     other aspects of health. These meetings will either be based on the Clinician's Guide, a     brief intervention for heavy drinking in primary care settings advocated by the National     Institute on Alcohol Abuse and Alcoholism, or Motivational Interviewing. Participants will be     assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. By the end of     treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest     among participants who receive the Clinician's Guide alone, intermediate among participants     who receive the enhanced Clinician's Guide, and lowest among participants who receive     enhanced Motivational Interviewing.   "
59936|NCT02501044|"     Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis     treatment, which may lead to hypoxia in the tissues.      The investigators hypothesize that:        1. The cumulative number, severity, or other characteristics of such deoxygenation episodes          may be a predictor of adverse outcomes in hemodialysis patients.        2. There may be demographic, anthropometric, clinical, treatment prescription, lab          analytical, and other parameters that correlate with the number and severity of          deoxygenation episodes and, therefore, may be used for risk stratification. Further,          some of these parameters may be modifiable.   "
59937|NCT02501031|"     The purpose of this study is to understand whether consuming flaxseed for approximately 50     days may beneficially affect the level of certain hormones in the blood thought to be     involved in the development of breast cancer. This study will address the first steps toward     the development of possible breast cancer prevention strategies. Differences in hormone     levels (from blood samples) will be compared between two groups of women - those in the group     assigned to eating ground flaxseed daily and those in the control group (with no change in     diet).   "
59938|NCT02501018|"     A prospective, open label, controlled, randomized, double arm, multi-center study to assess     the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to     arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and     potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).   "
59939|NCT02501005|"     The BERLIN VT study is designed to evaluate the impact of prophylactic ventricular     tachycardia (VT) ablation on all-cause mortality and unplanned hospital admission for     congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation (VF)     when compared to VT ablation after the third appropriate implantable     cardioverter-defibrillator (ICD) shock.   "
59940|NCT02500992|"     Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained     popularity. It is an appealing technique as a minilaparotomy in order to retrieve the     specimen is avoided. Therefore less postoperative pain and a better cosmetic result are     expected. The feasibility of the technique has been demonstrated.      Still an open question is the risk of intraperitoneal contamination as in this procedure the     colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened     rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in     order to fashion an anastomosis.      In this study the bacterial contamination in the rectal stump as well as in the peritoneal     cavity is assessed. The results are compared to bacteriological samples taken in a comparison     group consisting of conventional laparoscopic assisted sigmoidectomies.   "
59941|NCT02500979|"     This study is designed to investigate the clinical efficacy and safety of pramlintide     co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously     via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired     level of glycemic control using insulin therapy.   "
59942|NCT02500966|"     Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and     amenorrhea. This study will test a new device named DUDA Device (Dispositivo Uterino para     dilatar canal endocervical) placed just after the conization, in order to evaluate the     safety, efficacy and quality of life.   "
59943|NCT02500953|"     The objectives of this study are to evaluate the safety and tolerability of a single and     multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the     pharmacodynamics of ASP3325 orally administered three times a day.   "
59944|NCT02500940|"     The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy     schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in     patients with advanced nasopharyngeal carcinoma   "
59945|NCT02500927|"     The purpose of this study is to determine the safety, the antitumor activity and the     pharmacokinetics of ASP8273 in EGFR tyrosine kinase inhibitor (EGFR-TKI)-naïve patients with     non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.   "
59946|NCT02500914|"     This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC)     or large cell neuroendocrine carcinoma (LCNEC). SC-002 is an antibody-drug conjugate (ADC)     comprised of a monoclonal antibody linked to a potent chemotherapy.      The purpose of this study is to assess the safety and tolerability of SC-002 at different     dose levels, to determine the highest dose of SC-002 that can be given to patients with SCLC     or LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of     SC-002.   "
59947|NCT02500901|"     This is a phase I study to determine the safety and feasibility of the combination of     enzalutamide and niraparib in subjects with metastatic castration-resistant prostate cancer     (CRPC).   "
59949|NCT02500875|"     The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN     therapy without instillation in the treatment of infected surgical wounds. Investigators mean     to verify differences of effectiveness between the different types of instilled substances,     normal saline versus Amukine Med 0.5%.   "
59952|NCT02500836|"     Randomized, prospective, multi-center, double blind placebo-controlled parallel group study     of a Placebo Topical Solution versus Cocaine HCl 4% Topical Solution for safety and efficacy,     and Cocaine HCl 4% and 10% Topical Solution for Safety as an anesthetic prior to a diagnostic     procedure or surgery on or through accessible mucous membranes of the nasal cavities. Both     domestic (United States) and foreign sites are eligible, and both inpatient and outpatient     settings are eligible.   "
59953|NCT02500823|"     Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,     including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with     the initiation and development of cardiovascular disease. This study was undertaken to     investigate whether mtDNA copy number in peripheral blood cells could be used as a risk     predictor for coronary heart disease.   "
59954|NCT02500810|"     The purpose of this study is to determine whether monosialoganglioside are effective in the     prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer     patients, and improve the quality of life of patients.   "
59956|NCT02500784|"     The purpose of this study is to test the effects of long-term therapeutic doses of     formoterol, on a) cerebrospinal fluid (CSF) tau levels, and Amyloid Beta protein 40/42 levels     in the CSF, and b) cognitive function in people with mild to moderate Alzheimer' Disease     (AD).   "
59957|NCT02500771|"     This is a project to be funded by a Fast-Track Small Business Innovative Research to build     and test the feasibility of a new software prototype called V-Motive which will facilitate     the combination of two proven autism behavioral interventions: Applied Behavior Analysis     therapy (ABA) and Video Modeling (VM). The investigators will conduct a Phase I feasibility     analysis and Phase II pilot study of the V-Motive Prototype by observing a community therapy     providers' use of the prototype in a therapy setting. Investigators will observe the users     and record the success or failure of the performance of key functions of the software.     Investigators will also administer surveys. The study will answer research questions about     V-Motive's ability to perform its intended function: allowing interventionists to feasibly     leverage video modeling within ABA therapy with a minimal amount of overhead and labor.   "
59958|NCT02500758|"     Despite the wide variety of products and antiseptic agents, no agent is ideal for every     situation. The investigators would like to evaluate the difference in reducing bacterial     load, using 4% chlorhexidine digluconate and 3% parachlorometaxylenol after a preoperative     surgical scrubbing.   "
59959|NCT02500745|"     After obtaining a consent, bed side cardiac ultrasonography will be performed for cases     undergoing transesophageal echocardiography to evaluate the correlation between left atrium     volume and left atrial appendage flow velocity which can predict the thrombosis risk.   "
59960|NCT02500732|"     Objective: To determine if atomoxetine 40 mg bid in patients ≥18 years old with recurrent     vasovagal syncope will better prevent syncope during tilt testing than placebo.   "
59961|NCT02500719|"     The purpose of the current study is to develop a better understanding of the brain mechanisms     involved in psychological treatments for posttraumatic stress disorder (PTSD). This project     will build on past research using script-driven imagery in our lab by investigating brain     activity in areas activated during exposure to trauma-related cues. This project will also     develop new knowledge concerning volitional control of those areas. The ultimate goal of this     study is a better understanding of whether volitional control of these brain areas will     improve therapeutic outcomes. This process will first be piloted in a sample of healthy     controls. This will allow investigators to refine the methodology prior to recruiting a     sample with PTSD.   "
59962|NCT02500706|"     This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy     in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in     combination with insulin degludec in adults with Type 1 Diabetes Mellitus.   "
59963|NCT02500693|"     This trial is intended to evaluate the value of circulating tumor cells (CTC), in combination     with unenhanced (without injection of contrast media) low dose (to limit the effective     radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of Lung     cancer (LC).      LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55     years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of     false positive that require repeat follow-up and also invasive investigations, but also false     negatives with metastatic LC being discovered between screening rounds.      Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and     characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET     technique in a population at high risk for LC, i.e. COPD patients before LC was detectable on     LDCT.      The study will focus on patients at very high risk for lung cancer i.e. smokers and     ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD).      The study will enroll 600 participants who will undergo three rounds of screening at one year     intervals, each round combining search for CTC on a blood sample and LDCT. Each participant     will be followed for at least one year after the last screening round   "
59964|NCT02500680|"     The purpose of this study is to evaluate the safety, tolerance, and immunogenicity of     MAS-1-Adjuvanted seasonal inactivated influenza vaccine (IIV) (MER4101) with hemagglutinin     dose escalation compared to non-adjuvanted comparator IIV standard dose (SD) in healthy     adults and high dose (HD) IIV in ambulatory elderly subjects.      Hypothesis: Reduced hemagglutinin (HA) dose IIV formulated in MAS-1 adjuvant (MER4101) is     safe, tolerable and immunogenic in healthy young adults 18 - 49 years of age compared to SD     IIV and an optimal dose of HA formulated in MAS-1 adjuvant will be safe and immunogenic in     adults who are 65 years of age and older compared to HD IIV (from Phase 1A, known to be 9µg     of HA antigen).   "
59965|NCT02500667|"     The present study is designed to assess the effects of Rifampin on the pharmacokinetics of     N91115 in healthy subjects.   "
60000|NCT02500212|"     Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of     ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney     transplant patients.   "
59968|NCT02500628|"     Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to     familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated     with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will     provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then     provide an additional sample 2 hours later.   "
59969|NCT02500615|"     This study examines the acute effects in ECIG users of the two primary vehicles in ECIG     liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an     ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin     ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid     nicotine concentration, puff number, and interpuff interval all will be held constant).     Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in     each condition.   "
59970|NCT02500602|"     The proposed study will examine the efficacy of doxazosin in the treatment of PTSD and     alcohol use disorders.   "
59972|NCT02500576|"     The goal of this clinical research study is to learn if pembrolizumab, an infusion of     T-cells, chemotherapy (cyclophosphamide and fludarabine), and either high or low dose     interleukin-2 (IL-2) can help to control metastatic melanoma. The safety of this drug     combination will also be studied.      T-cells are white blood cells in your body that are important to the immune system. The     T-cells used in this study will be collected and grown in a separate study (MD Anderson     Protocol 2004-0069).   "
59973|NCT02500563|"     This clinical trial will evaluate the stool of infants fed one of two infant formulas, which     contain different types of proteins, or breast milk to determine if different proteins have     an effect on the type of bacteria that enters and lives in an infant's intestine early in     life.   "
59974|NCT02500550|"     The purpose of this study is to determine whether a repeat dose administration of ATIR101 is     safe and effective when infused in patients with a hematologic malignancy following a T-cell     depleted stem cell graft from a related haploidentical donor. All patients are planned to     receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or     halted for safety reasons.   "
59975|NCT02500537|"     A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.   "
59976|NCT02500524|"     To assess the efficacy and safety of 10% Cocamide DEA and Lyclear creme rinse (permethrin1%)     in the eradication of head lice. To assess the ability of each product to kill all viable ova     and to assess patient acceptability of the product in use.   "
59977|NCT02500511|"     To determine the persistence of protective antibody levels for subjects who seroconverted     after vaccination with NmVac4-A/C/Y/W-135-DT™      Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted     and asked to provide a blood sample at 12-24 months after vaccination with     NmVac4-A/C/Y/W-135-DT.      Serum Bactericidal Assays will be performed to evaluated duration of protective antibody     titer for NmVac4-A/C/Y/W-135-DT for all four serogroups. To determine if subjects who     seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24     months after vaccination.   "
59978|NCT02500498|"     The study is a retrospective cohort study that utilizes medical records from the BiologicTx.     Data accrual starts upon initial home infusion nurse visit until the most recent home     infusion nurse visit. Infusion related adverse events are quantified as number of patients     with adverse event over the total number of patients and number of event over total number of     home infusion visits.   "
59979|NCT02500485|"     The purpose of the study is to investigate the potential interaction between multiple oral     doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.   "
59980|NCT02500472|"     This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess     whether kava can alter NNK metabolism in humans.   "
59981|NCT02500459|"     Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this     study is to determine if treatment with topotecan by an alternative method, direct delivery     into the part of the brain where the tumor has spread, is safe and well tolerated. The     Cleveland Multiport Catheter is a new, investigational device that will be used to deliver     topotecan into tumor-infiltrated brain. A second purpose of this study is to determine     whether the Cleveland Multiport Catheter can be used effectively and safely to deliver     topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to     treatment with topotecan. This study will also look at the way topotecan is injected into     tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be     added to topotecan before it is injected. Pictures will be taken of the brain with an MRI     machine. This will allow the investigators to see where in the tumor-infiltrated brain the     topotecan has been injected. This study will collect medical information before, during, and     after treatment in order to better understand hot to make this type of procedure accessible     to patients.   "
60029|NCT02499835|"     This randomized pilot trial studies vaccine therapy and pembrolizumab in treating patients     with prostate cancer that does not respond to treatment with hormones (hormone-resistant) and     has spread to other places in the body (metastatic). Vaccines made from deoxyribonucleic acid     (DNA), such as pTVG-HP plasmid DNA vaccine, may help the body build an effective immune     response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may find tumor     cells and help kill them. Giving pTVG-HP plasmid DNA vaccine and pembrolizumab may kill more     tumor cells.   "
59982|NCT02500446|"     Several studies have suggested that despite suppressive combination antiretroviral therapy     (ART) in people who are HIV-positive, in some individuals there may be on-going viral     replication. Clarifying the extent of on-going viral replication on ART is important for the     development of HIV-1 curative strategies and for reducing HIV-1 associated immune activation.     The investigators hypothesize that treatment intensification with dolutegravir will inhibit     residual virus replication in HIV-1 infected patients on ART. The primary objective of this     study is to determine the effects of dolutegravir intensification on residual virus     replication in circulating cluster of differentiation 4 (CD4+) T cells.   "
60588|NCT02492516|"     Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and     lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only     therapeutic option now. Recently several studies have shown that stem cell transplantation is     safe and can be effective in reduction of disease progression and increase of quality of     life.   "
59983|NCT02500433|"     OBJECTIVE: To investigate whether VR videogames plus conventional therapy improves motor     control compared with conventional therapy in children with cerebral palsy (CP).      METHODS: Thirty participants with CP were included. A baseline (A0), a post-conventional     intervention (A1), a post-experimental treatment (A2) and a two-month follow-up (A3)     assessment were performed. Experimental intervention was based on videogames treatment     (Kinect-Kbox360TM) added to their conventional physiotherapy. Motor and the process skills     were evaluated by the Assessment of Motor and Process Skills (AMPS); balance by the Pediatric     Reach test (PRT); gait speed by the 10-meters walk test (10MW); and running and jumping     capacity by the Gross Motor Function Measure (GMFM).   "
59984|NCT02500420|"     Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic     cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the     left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an     important heterogeneity of prognosis and clinical expression going from a asymptomatic state     until the devastating sudden death occurring in a young person.The diagnosis of HCM is     definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial     history).This hypertrophy is often accompanied by other abnormalities detected by     echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral     regurgitation …Now, the current challenge is to determine the prognosis factors of the     disease that could help to identify the patients with high risk of sudden death. Some     prognosis factors are knowed and used in the calculation of a new risk score. This risk score     allows to estimate the risk of sudden death at 5 years and propose depending on the result,     the implantation of a defibrillator for primary prevention.The physiopathological mechanism     of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major     mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where     ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be     the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart     failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an     important mechanism of the disease evolution. Acute ischemic events could be a trigger of     malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is     long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis     appears at a very advanced stage of the disease. Exercice stress echocardiography permits to     detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis     apparition. Moreover the investigators suggest to study the deformation parameters by speckle     tracking or 2D strain witness of a contractile LV dysfunction before the apparition of     segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more     sensible technique to identify focal myocardial fibrosis resulting in areas of late     gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the     severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by     hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of     hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible     hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful     sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies     show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without     LGE which reflects the presence of new fibrosis.The objective of study is to compare these     two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually     used in the diagnosis or the monitoring of the disease. The investigators propose to realize     an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle     and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1     mapping.Actually the investigators consider that LGE is a risk factor of the disease     (although not yet involved in the calculation of the risk of sudden death) and need to be     study in each MRI realized for HCM. From the same way, the investigators suggest to follow     patients to determine if the abnormalities detected by these two techniques and particularly     2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are     prognosis factors of the disease and appear more precociously than LGE.   "
59985|NCT02500407|"     This study is designed to evaluate the safety and pharmacokinetics of BTCT4465A when     administered as a single agent by intravenous (IV) infusion to participants with relapsed or     refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an     expansion stage where participants will be enrolled into indication-specific cohorts.   "
59986|NCT02500394|"     This study evaluates the impact of a biomarked guided intervention on the development of     acute kidney injury in high risk surgical patients. Eligible patients are screened for marker     of tubular stress in the urine; if patient specific results are above a pre-defined cutoff     they are randomized into a standard care group or an interventional group in which patients     receive intensified volume therapy.   "
59988|NCT02500368|"     This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test     lens against the control lens.   "
59989|NCT02500355|"     Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under     Endoscope.   "
59990|NCT02500342|"     Thyroid hormone is a key regulatory hormone for a range of physiological systems. An impaired     function of the thyroid gland such as subclinical hypothyroidism (SCH) can affect quality of     life. Older adults with subclinical hypothyroidism often report non-specific symptoms such as     tiredness. In addition, muscle symptoms such as cramps, weakness and myalgia are more common     in SCH than in healthy controls. At present, evidence is lacking about the benefits of     thyroxine replacement in the elderly with SCH, as no large randomized clinical trials (RCT)     on the full range of relevant clinical outcomes, including tiredness have been performed.     Moreover, there is continued uncertainty about the long-term impact on health related quality     of life of thyroxine treatment for SCH. The aim of the study is to examine, within a large     RCT of elderly participants with subclinical hypothyroidism, the impact of thyroxine therapy     on the association between subclinical thyroid disease (SCTD) and the level of physical and     mental fatigue. The existing trial infrastructure (TRUST thyroid trial-Euresearch FP7;     clinicaltrials.gov ID: NCT 01660126) will be utilized to collect information on the level of     physical and mental fatigue by using the Pittsburgh Fatigability Scale at baseline and at 1     year from 220 participants with persistent subclinical hypothyroidism randomized to either     thyroxine or placebo.   "
59991|NCT02500329|"     This is a phase 4, single center, randomized, open-labeled study. The primary objective of     the study is to compare effect of gemigliptin and acarbose on endothelial function.      Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for     4 weeks.   "
59992|NCT02500316|"     Protocol CP-4-004-EXT is designed as an open-label extension study assessing long-term     MOD-4023 administration. It is open to subjects completing Phase 2 study in children with     growth hormone deficiency (CP-4-004).   "
59993|NCT02500303|"     The purpose of this study is to explore the factors that influence limb fitting in those with     diabetes compared to those without diabetes. The population without diabetes will usually     present with peripheral arterial disease (PAD) and are similar in management following LEA.     The impact that not walking with a prosthesis has long term on both populations will be     explored. In general, previous research has used retrospective analysis of case notes which,     although valuable, have fixed fields and only allow the researcher to look at associations     between factors not at causation. Additionally, very few have followed a population over     time. Therefore this study will be a prospective observational analysis of all those who     undergo a LEA in one year from 01/03/14 to 28/02/15 within the Greater Glasgow & Clyde area     with follow up at 6, 12 & 18 months from date of amputation.   "
59994|NCT02500290|"     This study aims to describe antiplatelet therapy in ACS in Andalusia and make an assessment     of efficacy and safety of hospital use Prasugrel / ticagrelor vs. Clopidogrel and Prasugrel     switching to / ticagrelor patients pretreated with clopidogrel.   "
59995|NCT02500277|"     This is a prospective study to assess the yield of pleural biopsy obtained with the routine     flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during     semirigid thoracoscopy   "
59996|NCT02500264|"     The aims of the study: To evaluate whether the use of a specific TENS technology can improve     GERD symptoms and esophageal acid exposure.   "
59997|NCT02500251|"     This study is a prospective, open label, phase I/II pilot study.   "
60030|NCT02499822|"     The purpose of this study is        1. to compare the effects of nifedipine GITS and ramipril on blood pressure variability in          subjects with elevated blood pressure variability.        2. to assess whether the degree of treatment-induced changes in blood pressure variability,          is related to the degree of regression (or progression) of organ damage in heart,          kidneys and carotid arteries.   "
59998|NCT02500238|"     Electronic cigarette use may be less harmful than cigarettes in adults, however, limited data     exists examining passive electronic cigarette exposure and child health outcomes. The current     study seeks to compare health-related outcomes among youth who reside with non-smokers,     cigarette smokers, and electronic cigarette users. The investigators propose to conduct a     small pilot study with 30 youth, ages 6-17 and a caregiver. Three groups of 10 parent-child     dyads will be recruited: 1) control group: parents who are non-smokers/non-vapers, 2) smoking     group: parents who are exclusive cigarette smokers, and 3) vaping group: parents who are     exclusively ECIG users. Groups will be compared across the following variables: child lung     function and biomarkers of nicotine.   "
59999|NCT02500225|"     The purpose of the study was to investigate the effects of etomidate or sevoflurane used in     electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery     profiles.   "
60001|NCT02500199|"     Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum     tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2     (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other     solid tumors that have no targeted agent as standard of care).      Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive     metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at     the RP2D (or MTD).   "
60002|NCT02500186|"     The objectives of this clinical study is to assess the effect of the amount of carbohydrate     intake and meals differing in glycemic index (GI) in patients of type 2 diabetes mellitus     treated with an SGLT2 inhibitor (Luseogliflozin), which inhibits glucose reabsorption from     renal uriniferous tubule, on glucose variability by using continuous glucose monitoring     (CGM), and to establish dietary therapy which reduces the risk of hypoglycemia in patients     treated with SGLT2 inhibitors. In addition, blood and urine samples are collected for     metabolome analysis that will be performed as an extension study of the clinical study.   "
60003|NCT02500173|"     To collect and analyze effects and side effects in patients undergoing radiotherapy.      This study investigates how analysis of effects and side effects will influence outcome of     patients. These retrospectively collected data allow to adapt and improve radiotherapy     treatment regimens .   "
60004|NCT02500160|"     Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA)     as a new technology for improving accuracy in restoration of the alignment and biomechanics     of the lower limb. PSI in TKA refers to custom-made cutting jigs manufactured according to     the patient's anatomic configuration of distal femur and proximal tibia based on preoperative     magnetic resonance imaging (MRI) or computed tomography (CT) scans. MRI- and CT-based PSI     systems are available from various manufacturers for preoperative planning. MRI offers     precise visualization of articular cartilage without the risk of radiation exposure, but it     is expensive and requires long scan times. In contrast, CT enables accurate identification of     the contour of the femur and tibia at short scan times, but it does not provide information     on the cartilage thickness and carries the risk of radiation exposure. As a result, there is     a possibility of some discrepancy between the thickness of bone resection proposed by MRI- or     CT-based PSI system and the actual thickness of bone cut. Although PSI has been the focus of     study in many recent researches, there has been no clinical study comparing MRI-based and     CT-based PSI systems in preoperative planning. Therefore the investigators questioned whether     the MRI-based PSI that reflects the cartilage layer would provide more precision in TKA than     the CT-based PSI. The purpose of this study was to investigate the accuracy of MRI-based PSI     and CT-based PSI in predicting bone resection thickness in TKA.   "
60005|NCT02500147|"     This project, A double-blind placebo-controlled randomized clinical trial assessing the     efficacy of metformin for hepatic fat in adolescents and young adults with polycystic ovary     syndrome, proposes exploring the use of novel and noninvasive methodologies in an at-risk     adolescent and young adult population with polycystic ovary syndrome (PCOS) who may gain     long-term health benefits from early detection and treatment of non-alcoholic fatty liver     disease (NAFLD). PCOS is a common condition that frequently presents in adolescence and young     adulthood and is defined by elevated androgens (male hormones) in the blood leading to 1.     hirsutism and acne and 2. menstrual abnormalities or amenorrhea. Affected individuals are at     increased risk of developing insulin resistance (a precursor of diabetes), NAFLD and lipid     (cholesterol) abnormalities.These features are all associated with the metabolic syndrome, a     rising major public health concern. Recently, an association between PCOS and NAFLD has been     noted but has only been superficially studied in the adolescent and young adult population.     The susceptibility of certain PCOS patients to developing NAFLD is theorized to be due to     having underlying insulin resistance, elevated androgen levels, and a genetic predisposition.     Metformin is an insulin sensitizing medication widely used to treat type 2 diabetes mellitus     that may have beneficial effects on insulin resistance-related conditions including PCOS and     NAFLD. Although widely used in PCOS, its effect on NAFLD in this group has not been     previously studied.      The primary aims of this proposal are: 1) To determine whether PCOS with liver fat >/=4.8%     treated with metformin for six months will have a decline in percentage liver fat compared to     a placebo group. 2) To measure the association of the PNPLA3 I148M allele with NAFLD in PCOS     at baseline (n=40). 2b) To measure the association of percentage liver fat with biomarkers of     NAFLD, dyslipidemia, insulin resistance and body composition at baseline (n=40) and after a     placebo-controlled intervention with metformin in PCOS with liver fat >4.8% (n=20).      The goal of this research proposal is to explore the use of novel and noninvasive     technologies in a young and at risk population. Dr. Sopher hopes to use the results of this     research to lay the groundwork for the prevention and treatment of NAFLD and other metabolic     disorders in adolescents and young adults with PCOS and to prevent lifelong morbidity     associated with PCOS.   "
60026|NCT02499874|"     The purpose of the study is to measure the drug levels in your blood and to find out whether     a reduced dose (400mg) of the anti-HIV medication Efavirenz is safe when taken during     pregnancy.      The study will recruit HIV infected women who take Efavirenz as part of their anti-hiv     treatment and who are pregnant.      Efavirenz has been shown to be safe in pregnancy and at the standard dose that everybody     takes of 600mg once a day, it shows levels that are enough to treat HIV and give birth to a     HIV negative baby.      Efavirenz at a dose of 400mg once daily works against HIV too but this dose has not been     given to HIV positive pregnant women.      People with HIV may benefit from using a dose of efavirenz of 400mg instead of 600mg, as     lower drug doses could have fewer side effects and be tolerated better.      Dose reduction would also make the drug cheaper. This would allow more people to be treated     and free up money for other important work in the fight against HIV such as education and     prevention programs.      However, it is not known whether 400mg of Efavirenz works as well as 600mg of Efavirenz     during pregnancy and this is why the investigators are conducting this study, which aims to     measure the amount of Efavirenz 400mg in HIV pregnant women's bodies when they are taking     400mg of Efavirenz once a day.   "
60031|NCT02499809|"     High intensity exercise can lead to muscle damage, resulting in muscle soreness, swelling and     reduction in muscle strength. If the recovery is not sufficient or efficient it can increase     the risk for injury and decrease the ability of the athlete to perform repetitive exercise     and maintain overall performance.      There are a variety of recovery aids which are being used by athletes, such as: the use of     compression garments, massage, cold water immersion, sauna etc. Additional recovery strategy     currently growing in popularity is the application of vibration.      The evidences regarding the benefits of vibration therapy as a recovery aid are limited,     specifically in athlete. Therefore, the proposed study will examine the use of vibration     therapy as a recovery tool. The efficacy of this technique will be measure using functional     and field tests.   "
60032|NCT02499796|"     This study compares the short-term effects of a new humidification system (Hygrovent Gold)     and two other humidification devices (heated and moisture exchanger and heated humidifier) on     respiratory pattern and work of breathing, during invasive ventilation.   "
60033|NCT02499783|"     This study will evaluate the efficacy and safety of adalimumab induction and maintenance     treatment in subjects with moderately to severely active Crohn's disease.   "
60006|NCT02500134|"     The limbus located between the cornea and the conjunctiva tissue, is important for not only     providing a barrier frontier to prevent conjunctival tissue invasion into the cornea,     containing nerves passing to the cornea, having blood and lymph vasculature for oxygen and     nutrient delivery, but also the niche environment of limbal stem cells.      So far, in vivo image systems are not able to visualize or identify the limbal stem cells     directly. One alternative practical is to visualize the histological morphology of palisades     of Vogt (POV), and to speculate the possible status of the stem cells accordingly. Slit-lamp     biomicroscope can be used routinely for clinical examination of the limbal morphology.     However, this technology does not allow for high resolution imaging of structural details and     only up to 20% of patients can be identified. In vivo confocal microscopy has been used to     visualize the POV and can provide cellular level resolution images, but the technique is     limited by high magnification that restricts the area of the scan, and requires contact with     the eye. Besides, both slit lamp biomicroscopy and in vivo confocal microscopy have the     limitation of not being able to give an overall view of the dimension and structure of the     whole palisades region.      Anterior segment optical coherence tomography (AS-OCT) is a noninvasive, rapid and     reproducible technique to evaluate the anterior segment and can also provide in vivo spatial     information. The purpose of the study is to assess the role of aging and regions on the     limbus.   "
60007|NCT02500121|"     This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial     of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with     metastatic urothelial cancer who have achieved at least stable disease on first-line     chemotherapy.   "
60008|NCT02500108|"     The purpose of this study is to assess the risk of serious cardiac events, specifically     ventricular tachyarrhythmia and sudden cardiac death (VT/SCD), associated with the use of     domperidone in a population of patients with Parkinson's disease. The hypothesis for this     study is that the risk of VT/SCD will be higher among domperidone users, especially at a     higher dose.      The investigators will conduct a retrospective population-based cohort study using health     care databases in eight jurisdictions in Canada and the UK. The study cohort will be defined     by the initiation of a new antiparkinsonian drug or a new diagnosis of Parkinson's disease.     The results from the separate sites will be combined by meta-analysis to provide an overall     assessment of the risk of VT/SCD in users of domperidone.   "
60009|NCT02500095|"     Background: Calorie restriction increases longevity in many species and attenuate the     development of chronic disorders including type 2 diabetes, cardiovascular diseases and     cancer. In mice reduced activity of insulin-like growth factor I (IGF-I) and/or insulin is     associated with extended longevity. Growth hormone (GH) is the main regulator of IGF-I     production, but the molecular mechanism whereby GH switches from IGF-I stimulation (protein     anabolism) to fatty acid oxidation (fatty acid catabolism) as well as induction of insulin     resistance during fasting remains enigmatic.      Hypotheses: The changes of the global set of metabolites, induction of insulin resistance,     and the shift in metabolism from protein anabolism to lipolysis together with the potentially     favorable effect of calorie restriction during fasting depend on preserved fasting-induced GH     secretion.      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in     signaling pathways that take place at the transition to the fasting state among healthy     overweight and obese subjects. Furthermore the investigators wish to determine the effect of     GH on the adaption of the metabolism to a fasting state.   "
60010|NCT02500082|"     The purpose of this study is to determine whether triheptanoin (UX007) is effective in the     treatment of neurological symptoms related to citrate transporter deficiency (SLC13A5 gene     mutation).   "
60011|NCT02500069|"     The appearance of intact macronutrients in the small intestine can result in the activation     of an intestinal brake; a negative feedback mechanism from different parts of the intestine     to the stomach, the small intestine and to the central nervous system. These processes     inhibit food processing, appetite sensations and food intake, and furthermore they increase     feelings of satiety and satiation. The researchers will investigate the effects of     intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food     intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and     glucose and insulin.   "
60012|NCT02500056|"     The aim of the present study is to determine whether usage of mesh with larger pores,     compared with mesh with smaller pores, would result in decreased rate of chronic pain after     open inguinal hernia repair.   "
60013|NCT02500043|"     The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC)     with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.   "
60014|NCT02500030|"     Neuromuscular diseases (NMD) are characterized by a reduced maximum insufflation capacity     (MIC), which contributes to increased morbidity and mortality from respiratory diseases.     Techniques such as glossopharyngeal breathing (GPB) and insufflation using a manual     resuscitation bag, or air stacking (AS), can be used to increase the MIC. These techniques     employ different mechanisms, and the ability to learn the technique plays a key role in its     proper implementation and effectiveness. The objective is compare the effects of AS and GPB     on the MIC in patients with NMD.      Children and adolescents with NMD who were users of non-invasive mechanical ventilation were     recruited. Vital capacity (VC) and MIC were measured prior to and after the intervention with     AS and GPB. Values were compared pre- and post-intervention and were considered statistically     significant if p <0.05.   "
60015|NCT02500017|"     This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot     clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of     Night Eating Syndrome (NES). The investigators will also look at the effect of melatonin     treatment on weight, metabolic parameters and sleep parameters in individuals with NES.   "
60016|NCT02500004|"     To study BAT activity and energy metabolism in patients with cachexia induced by cancer or     chronic disease.   "
60046|NCT02499614|"     Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1     translocation or MET amplification   "
60047|NCT02499601|"     The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12     months of follow up, and to evaluate the performance of the therapy in relieving symptoms and     restore diastolic function in patients with heart failure and preserved ejection fraction.   "
60017|NCT02499991|"     Research shows that there are a plenitude of interventions that can be used to enhance memory     for older adults; however, the evidence as to whether these interventions enhance memory for     daily activities is equivocal. The purpose of this pilot study is to test a memory     intervention that is potentially useful in everyday life. Objectives of the pilot study are:     1) to examine the feasibility of the intervention (e.g., ease of use of materials provided);     and 2) to gain preliminary evidence of the intervention's impact on recall of recent daily     social events. Participants will be 20 cognitively healthy (i.e. not cognitively impaired)     older adults, with 10 participants randomly assigned to either an intervention or control     group, respectively. The study will consist of: a) a pre-training session; b) seven days of     independent memory training; and c) a post-training session. The pre-training session will     involve a test that measures recall of daily social events from the previous week. This will     be followed by seven days of training for recall of daily social events. During the seven     days, the intervention group will perform daily memory tasks using self-instructional     materials given to them by the researcher, whereas the control group will use their own     strategies for remembering social events that they are involved in during the week. The     post-training session will occur after the seven days and will involve the same test as the     pre-training session that measures recall of social events from the previous week. The     hypotheses are that: a) recall of social events will be higher for the post-training test     than in the pre-training test and; b) recall will be better for in the intervention group     than the control group. The ease of use of the memory recall materials provided to the     intervention group will be assessed in interviews.   "
60018|NCT02499978|"     This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™,     DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV     viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be     effective in maintaining virologic suppression at 48 weeks of treatment.   "
60019|NCT02499965|"     The purpose of this study is to determine whether or not the pain of IV catheter insertion in     the Emergency Department can be reduced significantly with the use of a rapid acting topical     anesthetic spray and to determine whether or not healthcare providers who undergo such     treatment are likely to endorse its use in their future practice.   "
60020|NCT02499952|"     This is an open label, multi-institutional, single arm phase II trial of pembrolizumab in     patients with incurable platinum refractory germ cell tumors. No randomization or blinding is     involved.   "
60021|NCT02499939|"     The primary purpose of the trial is to determine the preliminary efficacy of therapeutic     ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced     peripheral neuropathy.   "
60022|NCT02499926|"     This research study is investigating if consuming more of one amino acid (arginine)     influences the digestion and absorption of another amino acid (lysine) due to competition in     digestion, in a healthy adult population.   "
60023|NCT02499913|"     Alcohol use and alcohol-related disorders are highly prevalent in soup kitchen users, and     this population is overrepresented by minorities and disproportionately affected by     alcohol-related morbidity and mortality. Contingency management is a behavioral intervention     effective in reducing substance use, but few studies have evaluated the efficacy of     contingency management in the context of soup kitchens or homeless programs. The     investigators found that contingency management, using a twice weekly testing and     reinforcement schedule, had benefits for decreasing drinking in individuals receiving     services at a homeless shelter. This study will replicate and extend these earlier findings     to a soup kitchen population using more sophisticated alcohol monitoring procedures to better     assess the extent of drinking in this group and in response to a contingency management     intervention reinforcing submission of negative breath samples. Specifically, 40 hazardous     drinkers recruited from a soup kitchen will be randomly assigned to one of two conditions:     alcohol monitoring or the same plus reinforcement for provision of daily negative breath     alcohol samples. The interventions will be in effect for 3 weeks, and all participants will     also wear transdermal continuous alcohol monitors during the intervention period. Objective     and subjective indices of alcohol consumption will be evaluated and compared between and     within the treatment conditions. This pilot project will provide information regarding the     effect size of contingency management reinforcing negative breath samples in an important     health disparities group, and results from this study will guide subsequent grant     applications focusing on methods to decrease drinking in this underserved population.   "
60025|NCT02499887|"     The purpose of the proposed study is to determine whether the addition of inhaled     corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat     emergency department (ED) visits among patients treated for acute exacerbations of asthma and     COPD discharged from the emergency department to home. The investigators hypothesize that     patients treated with inhaled corticosteroids in addition to oral corticosteroids and     albuterol will have lower rates of 30-day return visits to the emergency department than     those patients treated with oral corticosteroids and albuterol only.   "
60027|NCT02499861|"     This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the     isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the     maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory     leukemia and solid tumors. For the phase II study, only patients with relapsed or refractory     leukemias will be included. To further evaluate the treatment efficacy and gain further     insight into action of these drugs, the DNA methylation levels before and after treatment for     all participants, pharmacokinetics parameters such as through level for decitabine and     through and peak level for genistein will be measured. Pharmacogenomics testing for     decitabine will be performed prior to cycle 1 of treatment.      Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and     genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest     period.   "
60028|NCT02499848|"     To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically     significant localised low to intermediate prostate cancer.   "
60589|NCT02492503|"     Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent     cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic     equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian     cancer, performed in a cervix cancer population.   "
60034|NCT02499770|"     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor     efficacy when administered prior to carboplatin and etoposide in first line treatment for     patients with newly diagnosed extensive-stage SCLC.      The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a     randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase,     Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first     dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90     patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part     2 portion.   "
60035|NCT02499757|"     The investigators' aim is to test the prediction that sweet taste perception enhances the     ability of nicotine to induce neural plastic changes in brain reward circuits to increase the     saliency, liking and brain reactivity to the sight and vaporized flavor of electronic     cigarettes (e-cigarettes).   "
60036|NCT02499744|"     The investigators hypothesize that the Humidified High Flow Nasal Cannula(HHFNC) is effective     and safe as primary respiratory support in neonate with respiratory distress syndrome(RDS).     It is more convenient in HHFNC combined with kangaroo care.   "
60037|NCT02499731|"     Strong Hearts, Healthy Communities is a research study which aims to reduce cardiovascular     disease (CVD), improve quality of life, and reduce CVD related health care costs in rural     communities.      The investigators' aim is to better understand how changes in lifestyle can affect the health     of rural women and others in their communities.   "
60038|NCT02499718|"     Assessment of the effect and safety of noninvasive positive pressure ventilation for severe     stable chronic obstructive pulmonary disease   "
60039|NCT02499705|"     The purpose of this study is to investigate the effects of dietary exposure to artificial     sweeteners on taste sensitivity, preference and brain response in adolescents using fMRI,     psychophysical measures, and questionnaires. The investigators hypothesize that dietary     exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift     preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala     to sweet taste compared to sucrose.   "
60040|NCT02499692|"     Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites     across China, the primary endpoint is Technical success.   "
60041|NCT02499679|"     The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and     resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients     with coronary artery disease (CAD) in order to further inform patients, health care     providers, and other stakeholders about which technologies are most effective and efficient     in the diagnosis and management of CAD.   "
60042|NCT02499666|"     The purpose of this project is to objectively assess the change (improvement) in exercise     capacity in patients undergoing routine percutaneous coronary intervention (PCI) for chronic     total occlusion (CTO)   "
60043|NCT02499653|"     This study aims to analyze the impact of a brief psychological support intervention in the     promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic     Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of     this intervention on both physical and psychological well-being, and consequently, a     reduction of health costs.   "
60044|NCT02499640|"     The aim of the present study was to investigate the effects of cold water immersion (CWI)     during post-exercise recovery with different durations and temperatures on heart rate     variability (HRV) indices. 100 participants performed a protocol of jumps and a Wingate test,     and immediately afterwards were immersed in cold water, according to the characteristics of     each group (CG: control; G1: 5' at 9±1°C; G2: 5' at 14±1°C; G3: 15' at 9±1°C; G4: 15' at     14±1°C). Analyses were performed at baseline, during the recuperative technique (TRec) by CWI     and 20, 30, 40, 50 and 60 minutes post-exercise. The HRV indices average of all RR intervals     in each analysis period (Mean RR), standard deviation of normal R-R intervals (SDNN), square     root of the mean of the sum of the squares of differences between adjacent R-R intervals     (RMSSD), spectral components of very low frequency (VLF), low frequency (LF) and high     frequency (HF), scatter of points perpendicular to the line of identity of the Poincaré Plot     (SD1) and scatter points along the line of identity (SD2) were assessed. Comparisons between     groups and moments were performed using the technique of analysis of variance for repeated     measures in two scheme factors. A significance level of p<0.05 was considered.   "
60045|NCT02499627|"     This is a single-arm, open-label, multicenter, phase 2 clinical trial aimed at evaluating the     efficacy and safety of the combination of bendamustine and brentuximab vedotin as a first     salvage therapy in patients with relapsed or refractory Hodgkin's lymphoma or PTCL. A total     of 25 patients with PTCL, and 40 with Hodgkin's lymphoma are expected to be treated according     to this treatment protocol. In the study, intravenous bendamustine will be administered at a     dose of 90 mg/m2 on day 1 and 2 and brentuximab will be given intravenously at a total dose     of 1.8 mg/kg on day 1 of each 21 days-based cycle, for 6 cycles. All patients achieving a CR     can be considered eligible to peripheral blood stem cell mobilization (to be performed with     granulocytecolony stimulating factor alone) and may proceed to an ASCT at any time after     cycle 4.   "
60054|NCT02499510|"     The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed     to have superior radial strength, flexibility and durability compared to standard nitinol     stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and     efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular     disease in the femoropopliteal arteries.   "
60055|NCT02499497|"     This research study is studying the use of a targeted therapy called LY SARM, which is an     investigational drug from a new class of molecules called Selective Androgen Receptor     Modulators (SARMs) as a possible improvement in quality of life for participants who have     undergone radical prostatectomy. Androgens are a group of hormones that play a role in male     traits and reproductive activity.      The names of the study interventions involved in this study are:      - LY2452473   "
60627|NCT02492009|"     The proposed study is a pilot randomized controlled trial (RCT) of an electronic patient     decision aid (PDA) for antidepressant use in pregnancy. The overall aim of this pilot RCT is     to establish the feasibility of future large international RCT of the PDA's effectiveness.   "
60056|NCT02499484|"     The primary objective of this research is to determine if the addition of topical GTN over 24     weeks to a 12 week exercise programme improves clinical outcomes more than placebo GTN for     people with Achilles Tendinopathy.      Pain in the Achilles tendon is a common condition seen by physiotherapists and doctors. It     affects people involved in sports and those who are not. It can limit the ability to walk,     hop, jump and run. If the pain persists for longer than 3 months it can become extremely     difficult to abolish. As a result, people with this common condition can suffer from     prolonged pain and often the pain will persist and affect everyday activities.      While this is an easy injury to diagnose, it is not so easy to treat. Many treatments do     exist, but often just provide short-term relief until the pain returns. Specific     strengthening exercises have been shown to be beneficial in treating this condition.      The current project will study Achilles tendon pain in Irish adults at Connolly Hospital,     Dublin, and will take place from 2015 to 2019. In this study, there are two groups of     patients. Both groups will perform an exercise program for 12 weeks. Physiotherapists will     instruct them on how to perform the exercises. Each group will be given an ointment to place     on the sore tendon using an applirule. This ointment will be applied daily for 6 months. One     group will use an ointment containing nitroglycerin, the other group will use an ointment     with no active ingredient. This is called a placebo. The patients will apply the ointment     daily for 6 months.      The patients will be assessed at the start of the program and after 6, 12 and 24 weeks. Our     main question is to see whether this exercise program when combined with a nitroglycerin     ointment applied directly over the sore tendon can improve the outcomes and recovery time for     people who suffer with Achilles tendon pain.   "
60057|NCT02499471|"     Rationale: During the last decades, research in possible therapies for existing obesity and     developmental factors causing obesity has explosively increased. Recently renewed interest     aroused for a tissue playing a possible role in both development and therapy for obesity:     brown adipose tissue (BAT).      To define the relation between BAT and thyroid hormone, the investigators set up the     following research protocol. In this protocol BAT activity will be determined in subjects     that underwent thyroidectomy for well-differentiated thyroid carcinoma.      Objective: To study the effect of thyroid hormone and thyroid-stimulating hormone on brown     adipose tissue activity.      Study design: Determine BAT activity after thyroidectomy in well-differentiated thyroid     carcinoma patients.      Study population: Patients that underwent thyroidectomy for well-differentiated thyroid     carcinoma, male and female, aged 18-65 years.      Intervention: FDG-PET-CT-imaging ([18F]fluorodeoxyglucose positron-emission-tomography     computed-tomography) of BAT activity will be performed under cold stimulation twice.      For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be     in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will     take place in a euthyroid state 4 months after the start of thyroid hormone treatment.      For patients receiving recombinant-thyroid-stimulating-hormone injections, the first occasion     will be shortly after the injection in a state of high thyroid-stimulating hormone levels.     The second measurement will be in a euthyroid state 4 months after the injection.      Main study parameters/endpoints: The main endpoint of this study is the effect of thyroid     hormone and thyroid-stimulating hormone on BAT activity in kBq (kilobecquerel) and SUV     (standard uptake value). Secondary endpoints are the effects of thyroid hormone and     thyroid-stimulating hormone on energy metabolism, body core temperature, skin surface     temperatures and skin perfusion.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The absorbed radiation dose from the FDG PET-CT scan after administration of 74     MBq (megabecquerel) of 18F-FDG is 2.8 mSv (miliSievert).   "
60058|NCT02499458|"     Circulating tumor cells (CTCs) have prognostic value in several tumor types, and increasing     evidence suggests that molecular characterization of CTCs can serve as a liquid biopsy to     understand and address treatment resistance. The goal of this proposal is to demonstrate that     CTCs can be accurately enumerated and characterized in metastatic clear cell renal cancer     (CCRC) and can serve as prognostic/predictive biomarkers to improve treatment. The challenge     surrounding CTC analysis in CCRC is that most CTC technologies (including the clinical     gold-standard CellSearch®) depend in epithelial markers such as EpCAM that are expressed at     low or heterogeneous levels in CCRC. Members of the research team have developed a novel CTC     microfluidic technology that can effectively detect CTCs that are completely undetectable by     CellSearch® because of very low EpCAM expression, as well as allowing for CTC recovery for     downstream molecular characterization. The goal of this proposal is therefore to test the     hypotheses that (1) The microfluidics CTC technology will have better sensitivity/specificity     relative to the CellSearch in metastatic CCRC; and (2) Enumeration of CTCs in metastatic CCRC     patients (n=66) will have prognostic value, while molecular characterization of CTCs for     expression of biomarkers (VHL, VEGF, mTOR, HIF1/HIF2, AKT) related to CCRC etiology will be     predictive of response/resistance to targeted therapies. Although CCRC is relatively     uncommon, the lack of established adjuvant treatments and high cost of targeted therapies in     the palliative setting makes the search for new prognostic/predictive biomarkers an important     clinical goal.   "
60059|NCT02499445|"     In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different     anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site     concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane     (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI     effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of     Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control),     during vascular graft harvesting (harvesting), after completing graft construction     (postgrafting), and one day after surgery (postoperative).   "
60060|NCT02499432|"     To further increase the access of evidence based psychotherapies for Veterans with     Posttraumatic Stress Disorder, we propose to offer training and intensive consultation to     community-based providers in Cognitive Processing Therapy for Posttraumatic Stress Disorder.     However, we believe that many clinicians may not implement Cognitive Processing Therapy or     take advantage of consultation after initial training. For this reason, we propose to examine     the effectiveness of an enhanced training method, which would add Motivational Interviewing     to the standard Cognitive Processing Therapy training. Motivational Interviewing is a form of     collaborative discussion for strengthening motivation and commitment to change. We     hypothesize that augmenting the standard Cognitive Processing Therapy training with these     techniques will reduce providers' reluctance to fully implement the interventions.   "
60073|NCT02499263|"     This is a prospective, single country, multi-center study in Ulcerative Colitis (UC) patients     treated with adalimumab. 200 subjects will be enrolled at approximately 20 sites. The     baseline assessment should be performed prior to the first dose of adalimumab (Visit1). Study     visits will be conducted at weeks 8, 16, 24, 32, 40, 48 and 56 in accordance with clinical     practice. All subjects will have one Follow-up for safety approximately 70 days after the     last dose of adalimumab   "
60077|NCT02499211|"     Using a cluster randomized controlled design, this study will evaluate effects of in-store     healthy food marketing strategies on sales and purchase of specific healthier items in six     product categories (milk, frozen entrees, beverage checkout coolers, salty snacks, bread and     cheese); and examine the effects of changes in in-store food marketing environments on sales     of healthier foods. If these strategies are found to be effective, they could be used widely     to encourage healthy retail sales, complement food access initiatives, and reduce health     disparities in obesity and other diseases. Supermarkets will be the unit of randomization,     intervention, and analysis.   "
60635|NCT02491905|"     This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in     non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low     dose, high dose, and placebo control group.   "
60061|NCT02499419|"     Mitral valve prolapse (MVP) is a relatively common cardial problem in which one or more of     the leaflets of the mitral valve prolapse during systole into the left atrium.      The disease is very heterogeneous and can vary from a benign disease with almost no impact on     the patient's life to a severe cardiac problem with many complications and high mortality     rate.      The purpose of the study is to see if the investigators can find a relation between the     severity of the MVP to the exercise capacity of the patient. The investigators also want to     see if they can find a difference between the exercise capacity of mild MVP patients and     healthy people.      To evaluate the exercise capacity of the subjects the investigators use Cardiopulmonary     Exercise Testing (CPET). CPET is probably the best known way to get a full picture of the     subject's functions during exercise. By combining gas exchange monitoring and ECG during a     controlled exercise in which the subject reaches maximal effort, the test gives information     about the cardiac, the pulmonary and the metabolic functions of the subject. This information     can help identify if there is a problem to perform exercise properly and more specifically if     the limitation is due to a cardiac, pulmonary or metabolic problem.   "
60062|NCT02499406|"     Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of     Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion     dysregulation.   "
60063|NCT02499393|"     New 2010 neonatal resuscitation guidelines state that offering therapeutic hypothermia (TH)     should be a standard of care in managing neonates with perinatal hypoxic - ischemic insult     and present with signs of moderate and/or severe hypoxic - ischemic encephalopathy (HIE) .     Despite the evidence from several randomized control trial (RCT) proving its effectiveness,     its effect is perceived insufficient or only modest. Thus today's research efforts are     directed toward finding the new possibilities of enhancing the effects of hypothermia. List     of agents with potential neuroprotective properties includes: erythropoetin, melatonin,     topiramate, morphine, xenon, MgSO4. Given investigators previous experiences with preterm     neonates exposed to MgSO4 prenatally or administered this drug after birth because of     perinatal asphyxia, the investigators designed the trial which would evaluate the possibility     of increasing the TH effect by combining this method with MgSO4. Until now there are several     published studies evaluating the effectiveness of MgSO4 in the group of asphyxiated neonates,     including one RCT. However, all of these studies were conducted before the era of TH     Furthermore, irrespective of the potential benefits, safety of using MgSO4 during TH in the     group of term neonates was not studied. It is particularly important in the light of the     results presented by Mittendorf et.al. They studied the effects of prenatal aggressive     treatment with MgSO4 on the outcome of preterm neonates showed that patients exposed to high     doses of MgSO4 were at higher risk of severe intracranial bleeding. Other side effects of     high serum magnesium levels are: vasodilatation, hypotension, cardiac arrhythmias,     coagulopathy, and gastrointestinal disturbances. MgSO4 is a very attractive neuroprotective     option,also because of its easy availability. Drug can be administered in the birth hospital     while neonate is being prepared for the transport to TH center. Timing of the intervention is     very important for neonates suffering from perinatal asphyxia. Both TH and administration of     potentially neuroprotective drug should be started during therapeutic window. It is the     initial potentially reversible phase of hypoxic insult lasting about 6 hours. If the     long-term follow up shows that MgSO4 has an additive neuroprotective effect and no     significant side effects in the group of asphyxiated neonates treated with TH this relatively     simple and not expensive intervention may be introduced into clinical practice   "
60064|NCT02499380|"     The objective of this post-marketing study is to advance the understanding of the mechanism     of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac     performance in patients with emphysema treated with the RePneu Coils, when used as intended.   "
60065|NCT02499367|"     This is a single center non-blinded randomized non-comparative phase II trial. The first     stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1     with no induction treatment before nivolumab).      For the second stage, the number of arms will be reduced based on the results obtained in the     first stage.   "
60066|NCT02499354|"     The purpose of the study is to determine the relative effect size of standard IV and oral     iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of     treatment response.   "
60067|NCT02499341|"     The purpose of the study is the comparison between ketamine and tramadol, regarding the     analgesia quality and efficiency, in patients receiving Patient Controlled Analgesia (PCA)     morphine, after major upper abdominal surgeries such as hepatectomies, gastrectomies, Whipple     procedures and peripheral pancreatectomies. The goal is to bring out an improved analgesia     scheme, which can be applied to the clinical work and refine the analgesia provided for major     procedures which require increased postoperative opioids doses. In the study, half of     patients will receive continuous intravenous infusion of tramadol and Patient Controlled     Analgesia morphine and the other half will receive continuous intravenous infusion of     ketamine and Patient Controlled Analgesia morphine postoperatively after major upper     abdominal surgery. The successful combination of different drugs targets at the improvement     of the analgesia provided, the reduction of complications and the exploitation of the     pharmacodynamic properties of each drug.   "
60068|NCT02499328|"     This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a     dose-escalation, safety run-in Part A and a dose-expansion Part B   "
60069|NCT02499315|"     The purpose of the study is to find out if AMG 357 is safe and tolerated by women with     Rhematoid Arthritis.   "
60070|NCT02499302|"     The general aim of this study is to investigate the effect of an individually tailored mental     training program in adolescents developing chronic fatigue syndrome (CFS) after an acute     Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint),     symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of     disease mechanisms (autonomic, endocrine, and immune responses).   "
60071|NCT02499289|"     Polycystic ovary syndrome (PCOS) has a heterogeneous clinical presentation comprising     reproductive (hyperandrogenism, menstrual irregularity, anovulation, infertility, pregnancy     complications), metabolic [insulin resistance (IR), increased type 2 diabetes mellitus (T2DM)     and cardiovascular disease (CVD) risk factors] and psychological features (worsened quality     of life and increased anxiety and depression) Whether prolonged fasting during Ramadan breaks     the insulin resistance state of polycystic ovarian syndrome and subsequently improve the     ovulation and spontaneous pregnancy will happen without ovarian stimulation.   "
60072|NCT02499276|"     Experimental animal data suggest that increasing breathing pattern variability in mechanical     ventilation could be beneficial. Variable ventilation can be induced through the following     modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and     Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each     other. Pilot observations in our department suggest a feasibility in patients.      The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the     variability of the breathing pattern, patient-ventilator asynchrony, risk of lung     overdistension, gas exchange, and repartition of ventilation.   "
60078|NCT02499198|"     Smokeless tobacco users who are unable or unwilling to quit tobacco use may be exposed to the     potent oral and esophageal carcinogen NNN not only from tobacco itself, but also via its     endogenous synthesis from nornicotine. The proposed study will lead to an understanding of     the endogenous formation of NNN from nornicotine in humans, and will also investigate the     effect of the reduction of nornicotine content in smokeless tobacco on the extent of     endogenous NNN formation. The knowledge gained in this study will lead to the development of     recommendations for the regulation, or potentially elimination, of nornicotine in smokeless     tobacco products in order to minimize exposure to NNN in the users of these products.   "
60079|NCT02499185|"     To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra     abdominal surgery.   "
60080|NCT02499172|"     This study, to be carried out immediately following an emergency, reactive cholera     vaccination campaign in Nsanje District, Malawi, will be a cohort study to estimate the     safety of killed oral cholera vaccine (OCV), in pregnant women as measured by ShancholTM, on     pregnancy outcomes and birth defects. While limited evidence which suggests that the vaccine     is safe in pregnant women, this setting will allow investigators to answer this question in a     community where more than 100,000 people will receive vaccine with no restrictions on     pregnancy status. In past cholera vaccine campaigns including clinical trials, pregnant women     were excluded due to lack of safety data. However, in this campaign, the decision by the     Ministry of Health is that the benefits of offering vaccine to all individuals regardless of     pregnancy status far outweigh any theoretical risk. Here the investigators specifically     propose to:      Specific Objective 1: To conduct surveillance of pregnant women to detect adverse pregnancy     outcomes within communities in Nsanje District, Malawi that received oral cholera vaccine in     a reactive vaccination campaign that started on 30 March 2015. Through household surveying     and enrollment of pregnant women with monthly follow-up visits, the investigators will     determine the cumulative incidence of adverse pregnancy outcomes among vaccinated and     unvaccinated women in Nsanje and Chikwawa Districts, Malawi.      Specific Objective 2: To compare the cumulative incidence of pregnancy loss (miscarriage and     stillbirth) of women who received oral cholera vaccine while they were pregnant to women who     were vaccinated and became pregnant after the end of the final round of vaccination in Nsanje     and Chikwawa Districts, Malawi.      Specific Objective 3: To compare the incidence of newborn malformations in a cohort of     infants that had fetal exposure to oral cholera vaccine compared to those without such     exposure in Nsanje and Chikwawa Districts, Malawi.   "
60081|NCT02499159|"     This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on     decreasing the amount of consumed pain medications.      Patients will be randomly selected to received either Exparel or standard bupivicaine     injection during surgery. Patients will be followed up to assess pain levels using a visual     pain scale, and to assess how much pain medication was consumed.   "
60082|NCT02499146|"     As part of the global clinical development program for Palbociclib, studies are planned in     cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients,     as required by the Chinese Health Authorities, is therefore warranted. In addition, safety     and efficacy will be also evaluated.      The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be     characterized.   "
60083|NCT02499133|"     Researches that focus on the perception of prosodic elements among adult who suffered     traumatic brain injury (TBI), focus on their ability to decipher intonation in order to     understand an additional meaning of a sentence. According to these researches, adults who     suffer from TBI, with no signs of Aphasia, have difficulty perceiving and deciphering     intonation (Marquardt et al., 2001; Angeleri et al., 2008). The current research asks to     broaden the knowledge in this domain by examining the ability of adults with TBI to     understand an additional prosodic element - focused stress.      The ability to identify and understand focused stress in a sentence requires different     abilities. First, a psychoacoustic ability in order to detect the stressed word. Second, an     ability to understand the lexical grammatical meaning of the word as it negates other     possible meanings (for example, in the sentence I'm eating a red apple the stressed word     negated the option of a different color). Third, an understanding of the stressed word as it     creates a different pragmatic/social meaning (for example, in the sentence mom, I asked for     red, yellow and green candy the role of the stressed word is to mark the candy that the     addressee didn't get).      The aim of the study is to assess the ability of adults who had experienced TBI to grasp and     understand the meaning of focused stress in the different contexts that were described above.     An additional aim is to examine if differences in speech and cognitive abilities can describe     some of the variation in the results.      Thirty adults between the ages of 18-50 years will take part in this study, fifteen adults     who had experienced moderate to severe TBI (0.5-3 years post injury) and fifteen healthy     adults. Each participant with TBI will be matched to a healthy adult by gender, age,     education and social-economic status. All of the participants will be Hebrew native speakers,     with no learning disability, no neurological injury, proper speech abilities and no hearing     impairment.      The participants will undergo seven different tests in three different meetings (60 minute     each), in a quiet room at Sheba - Academic Medical Center Hospital. The tests will include     different cognitive and language examinations. The main test of the study will be The Hebrew     Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires     identification of the stressed word in a sentence based on psychoacoustic abilities alone.     The second and the third subtests require understanding the meaning of focused stress in     different contexts - lexical grammatical and pragmatic/social. The test includes forty eight     recorded sentences. In each sentence one word is stressed. The participants will be asked to     listen to the recordings and answer a closed question regarding the stressed word.   "
60084|NCT02499120|"     The purpose of this study is to determine whether the combination of palbociclib with     cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative,     cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and     neck.   "
60085|NCT02499107|"     This study will compare the effects of commonly consumed carbohydrate sources such as     potatoes, pasta and rice along with a fixed portion of meat on blood glucose, satiety and     insulin levels among healthy body weight children. Healthy boys and girls, aged between 11 -     13 years old, will be involved in this study.   "
60086|NCT02499094|"     The purpose of this study is to validate the effectiveness of using an integrated mobile     sensing platform to deliver large-scale data-driven interventions to patients with     depression.   "
60087|NCT02499081|"     The purpose of this study is to evaluate the effect of Ixazomib on inducing osteoblast     activation as measured by bone markers and imaging in patients with relapsed/refractory     myeloma.   "
60088|NCT02499068|"     The purpose of the study is to verify the clinical effectiveness of a managed home     telemonitoring program in patients with severe COPD against usual clinical practice, as     measured by the decrease in the number of exacerbations, number of hospitalizations, hospital     days and emergency room visits in a 12 month period      The primary endpoint of effectiveness is severe exacerbations avoided.      The main hypothesis is that patients with severe or very severe COPD patients managed with a     home telehealth program have better outcomes than patients managed according to usual     clinical practice.   "
60198|NCT02497638|"     This study is a randomized trial examining the administration of a combination of biguanide     metformin and atorvastatin (Lipitor) to men who are experiencing rising prostate-specific     antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).   "
60123|NCT02498613|"     This phase II trial studies cediranib maleate in combination with olaparib in treating     patients with solid tumors that have spread to other parts of the body or cannot be removed     by surgery, including breast cancer, non-small cell lung cancer, small cell lung cancer, and     pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the     flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.   "
60089|NCT02499055|"     Background. In Denmark, about 350,000 persons suffer from anxiety. Public health-care     services plan to implement internet based self-help psychotherapy (IBT) to be an important     alternative and supplement to ordinary face-to-face therapy. Meta-analyses indicate that the     effect of IBT for anxiety disorders seems better than no intervention, and in some instances     equal to 'usual therapy'. But studies have been characterised by small sample sizes, high     risk for bias, including high dropout.      Objective. The objective of this pilot trial is to assess the feasibility of conducting a     larger confirmatory trial investigating the benefits and harms of an internet-based self-help     therapy program, FearFighter™, compared with no intervention for persons with an anxiety     disorder.      Design. An investigator-initiated feasibility randomised clinical trial investigating     internet-based therapy with FearFighter™ compared with no intervention for persons with an     anxiety disorder. We will include 64 participants.      Eligibility criteria. Inclusion criteria: age 18 or older; specific phobia, panic disorder,     agoraphobia, or social phobia is the primary diagnosis according to the DSM-IV; and informed     consent. Exclusion criteria: suicidal risk; ongoing episode of bipolar disorder or psychosis;     concurrent psychological treatment for the anxiety disorder; unable to attend the     intervention; or lack of informed consent.      Intervention. The intervention group will use the program FearFighter™, a nine session     cognitive behavioural self-help therapy program delivered over the internet during nine     weeks. The control group receive no intervention for nine weeks.      Outcomes. Feasibility outcomes are the fraction that are eligible, the fraction that are     randomised, and the compliance in the intervention group. Clinical exploratory outcomes are:     remission, Beck Anxiety Inventory, Symptom Check List-90R, WHO Well-Being Index, Sheehan     Disability Scale, serious adverse events, and behaviour log from FearFighter.      Time schedule. Participants will be included in the trial from July 2015. Results are     expected in February 2016.   "
60090|NCT02499042|"     This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen     delivery in adult patients who have been resuscitated from OHCA.   "
60091|NCT02499029|"     Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in     veterans with PTSD and comorbid substance use disorders.   "
60092|NCT02499016|"     Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain     additional benefits such as a better cosmetic outcome, the investigators developed a surgical     option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a     non-visible scar, that was preliminarily shown to be feasible and safe in our previous     retrospective studies To further evaluate the feasibility, safety and cosmetic results of     this innovative approach, the investigators compared the outcomes of SSILA and CLA by     performing a randomized controlled trial.   "
60093|NCT02499003|"     The purpose of this study is to evaluate the overall response rate of Obinutuzumab (GA101) in     combination with Pixantrone in patients with relapsed aggressive B-cell lymphoma. 70 patients     with diffuse large B-cell lymphoma, follicular lymphoma grade IIIB or transformed indolent     lymphoma will receive up to 6 cycles of the described combination regimen. Follow up visits     are scheduled for up to 3 years.   "
60094|NCT02498990|"     The primary hypothesis is to investigate whether a low calorie diet for 7 weeks followed by     continuous lifestyle advice is an effective option to achieve an improvement in glucose     control as measured by HbA1c after 52 and 104 weeks as compared to baseline values in obese     type 2 diabetes patients on either tablet or insulin treatment. The secondary hypothesis is     to investigate whether the weight reduction therapy also has significant impact on various     anthropometric, clinical and metabolic parameters associated with obesity.   "
60095|NCT02498977|"     LIFT is prospective randomised marker-based trial to assess the clinical utility and safety     of biomarker-guided immunosuppression withdrawal in liver transplantation. 'LIFT' aims to     validate a biomarker test of operational tolerance to stratify liver transplant recipients     before withdrawing immunosuppressive medication. Primary objective is clinical utility and     risk/benefit ratio of employing a transcriptional test of tolerance to stratify liver     recipients prior to immunosuppression withdrawal. Secondary objectives are: safety of     biomarker-guided immunosuppression withdrawal; health-economic and quality of life impact of     biomarker-guided immunosuppression withdrawal; improvement in drug-related co-morbidities;     prevalence of tolerance over time; role of donor-specific anti-human leukocyte antigen (HLA)     antibodies; identify mechanisms of liver allograft tolerance. It is a prospective,     multi-centre, phase IV, biomarker-strategy design trial with a randomized control group in     which adult liver transplant recipients will undergo immunosuppression withdrawal. The sample     size is 148 patients.   "
60096|NCT02498964|"     High fidelity simulations provide a unique opportunity for teaching and evaluation of     knowledge, clinical reasoning, decision making and teamwork. We have developed a series of     novel cardiac based simulations that review difficult learning objectives of cardiac     anesthesiology rotation. We hypothesized that residents who have completed a rotation in     cardiac anesthesiology will perceive these simulations to be both mentally challenging and a     useful tool in preparing them for their subsequent clinical experience and for their     anesthesiology board. For the first time, we have used the NASA Task Load Index Scale in     evaluating Neuro Cognitive Workload during Cardiac Anesthesia Based simulation scenarios     .Residents who have completed the cardiac rotation at least once would be assigned the task     in small groups either a group of 2 or group of 3.The module consists of 3 different     scenarios. The scenarios include, weaning the patient off of cardio pulmonary bypass,     management of severe protamine drug reaction and acute hypotension from malfunction of the     coronary graft in a simulated operating room in real time.        1. Setting up a Simulation Lab,almost similar to real cardiac operating rooms would have          cardio-pulmonary bypass machine,transesophageal echocardiography images upon request,all          emergency medications with various infusions pumps,defibrillator,real time monitors          include EKG,SpO2,invasive arterial line,CVP,PAP,ETCO2,operating room surgical          equipment,anesthesia machine with ventilator.        2. Tasks Assigned to the residents        3. Feed-back and Teaching Session        4. At the end of each session residents are encouraged to reflect upon how they performed          and learning gaps that they perceived and areas that they felt needed to improve upon.        5. Feedback session would be followed by interactive teaching to reinforce the knowledge.        6. Evaluation of Hypothesis using NASA TLX Scale. Immediately following the Simulation          based training, residents would be given the paper based NASA TLX scale to assess the          neurocognitive workload   "
60097|NCT02498951|"     This randomized phase II trial studies how well obinutuzumab works as maintenance treatment     in patients with central nervous system lymphoma who have achieved the disappearance of all     signs of cancer in response to treatment (complete response). Monoclonal antibodies, such as     obinutuzumab, may kill cancer cells that are left after chemotherapy.   "
60098|NCT02498938|"     Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases.     The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with     COPD serve as a risk factor for developing periodontitis.   "
60119|NCT02498665|"     This is a multicenter, open label, Phase 1 dose-escalation study of DSP-7888 Dosing Emulsion     administered to adult patients with advanced malignancies. Patients will be administered     escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance     with the following regimen: once weekly for four weeks during the Induction Phase, once every     7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a     discontinuation criterion is met during the Maintenance Phase.   "
83516|NCT02192827|"     The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs.     two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.   "
60099|NCT02498925|"     The prevalence of major depressive disorder (MDD) is relatively low in childhood (i.e.,     1-3%), but increases substantially during adolescence. By the age of 18, approximately 15% of     adolescents will have experienced at least one episode of MDD. A growing body of research     implicates abnormalities in reward circuitry as playing a critical role in the development     and maintenance of depressive symptoms in adolescents. Importantly, these reward-circuitry     abnormalities have been linked to anhedonia (i.e., decreased pleasure or blunted reactivity     to rewarding stimuli). Behavioral Activation (BA) represents a promising - and relatively     simple to deliver - nonpharmacologic intervention for adolescent depression, which has been     shown to be at least as effective as Cognitive Behavioral Therapy (CBT) with regards to     symptom reduction and lowering the risk of relapse in adult samples. More recently, promising     data have emerged from the application of BA to depressed adolescents. BA can be     conceptualized as a treatment directly targeting anhedonia. More specifically, BA targets     anhedonia through behavioral change strategies aimed at gradually increasing patients'     exposure to and engagement with rewarding stimuli and positively reinforcing experiences.     Given this treatment focus, BA may be particularly beneficial for adolescents struggling with     relatively elevated levels of anhedonic symptoms. Accordingly, the present study will examine     the role of anhedonia and reward functioning in predicting treatment response in BA. In     addition, analyses will be conducted examining the reward-related neural and behavioral     mechanisms underlying anhedonic symptom improvement in BA.   "
60100|NCT02498912|"     The purpose of this phase I study is to test the safety of different dose levels of specially     prepared cells collected called modified T cells. In the screening part of this study the     tumor was found to have a protein called MUC16. This protein is present on about 70% of     ovarian cancers. The investigators want to find a safe dose of modified T cells for patients     with this type of cancer that has progressed after standard chemotherapy. We also want to     find out what effects these modified T cells have on the patient and their cancer.   "
60101|NCT02498899|"     The goal of this research study is to learn how patients view their doctor's compassion about     supportive care and treatment options for advanced cancer patients.   "
60102|NCT02498886|"     At MRC Human Nutrition Research, the investigators have developed an engineered analogue of     the ferritin-core for safe and effective iron supplementation. Iron hydroxide adipate     tartrate (IHAT) is a tartrate-modified, nano-disperse Fe(III) oxo-hydroxide, formed in an     adipate buffer, with similar functional properties and small primary particle size (~2 nm) as     the iron found in the ferritin core; it better mimics iron absorption from food than the     non-physiological bolus doses of ferrous sulphate currently used.      This exploratory study will test the hypothesis that IHAT has equivalent bioavailability to     ferrous sulphate but produces a less harmful post-ingestion rise in transferrin saturation.     The design is a 3-arm (IDA, non-IDA and IDA-IHAT new manufacture), crossover, randomised,     single-dose study.      Primary endpoint:      Relative bioavailability value of IHAT versus ferrous sulphate. This will be determined from     the red blood cell incorporation of isotope-labelled iron 14 days following a single oral     dose.      Secondary endpoints:      Serum iron at 0, 2, 4, 6 hours following a single dose of each iron compound. Transferrin     saturation at 0, 2, 4, 6 hours following a single dose of each iron compound.      Plasma 58Fe and 57Fe at 0, 2, 4, 6 hours. Pathogen growth using ex vivo assays in serum     collected from each subject at 0, 2, 4 and 6 hours following a single dose.   "
60103|NCT02498873|"     In a competitive scenario, trainers and coaches seek to improve the performance of their     athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training     aimed at a specific moment of a competition. The organization variables, mainly the intensity     of exercise in a training routine can stimulate important physiological pathways and uphold     superior gains to VO2max, leading to a peak aerobic performance. However, due to lack of     evidence, and the difficulty of control on a large scale, the effects of the intensity     organization over a mesocycle periodization are still poorly investigated.   "
60104|NCT02498860|"     Two-Year Disease Free Survival Rate of Stage IB~IIIA adenocarcinoma after Adjuvant     Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be     recruited for 12 months, and followed for two years, thus the duration of study will be 36     months.   "
60105|NCT02498847|"     Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and     disability. Non-pharmacological interventions are recommended but are underutilized. Exercise     reduces pain and improves physical function, but benefits tend to wane without a component to     facilitate behavior change. Cognitive behavioral therapy (CBT) has long term benefits on pain     and physical function in individuals with OA, but is not typically offered in clinical care.     CBT could be taught in the context of clinical care by occupational therapists (OT). OTs help     people manage chronic conditions by teaching behavioral strategies that promote health and     function. The purpose of this study is to test the feasibility and efficacy of an     OT-delivered cognitive behavioral therapy program to help people manage their knee OA.   "
60106|NCT02498834|"     The purpose of this study is to conduct a randomized controlled trial with English and     Spanish-speaking adolescents to compare the effectiveness of an adolescent asthma question     prompt list with a supportive educational video intervention with usual care.      The hypothesis of this study is that by showing the parents and adolescents the educational     video and then providing the adolescents with the one-page asthma question prompt lists to     use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in     managing asthma, and (c) adolescent quality-of-life.   "
60107|NCT02498821|"     The purpose of the study is to evaluate differences in the time and costs between Sherlock     3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter     (PICC).   "
60120|NCT02498652|"     This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic     (PD) effects of RDEA3170 administered in combination with allopurinol compared with     allopurinol administered alone in adult subjects with gout.   "
60121|NCT02498639|"     Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy     and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid     ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary     pacemaker device with CE mark). It is expected to enroll 100 patients. Randomization is done     through a dedicated computer program.   "
60108|NCT02498808|"     Neutrophils emerge as key immune cells in the initiation and perpetuation of immune responses     in autoimmune diseases. They display marked abnormalities in phenotype and function in     various autoimmune diseases, including systemic vasculitis, systemic lupus erythematosus     (SLE) and rheumatoid arthritis (RA).      These neutrophils are characterised by an extended life span, increased capacity to produce     reactive oxygen species, active gene expression and release of extracellular traps.     Consequently, there is a need for better understanding of neutrophil phenotype and functions     in these conditions, as well as for identifying molecules capable of specifically     manipulating neutrophil function. The investigators have recently discovered that interferon     lambdas (IFN-λs), also known as interleukin 28 (IL28) and interleukin 29 (IL29), class II     cytokines with previously studied anti-viral biological functions, specifically suppress     neutrophil infiltration and interleukin-1β production and thereby, halt and reverse the     development of collagen induced arthritis (CIA). The investigators propose to further     investigate the cellular and molecular mechanisms behind this suppression and examine the     translational potential of the investigators' finding by examining the IFN-λ receptor     expression and function in neutrophils isolated from the blood of healthy donors and     rheumatic patients (early rheumatoid arthritis and vasculitis).   "
60109|NCT02498795|"     The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional     form to the accomplishment of eccentric exercise's program in patients with chronic patellar     tendinopathy is more effective than the accomplishment of an additional treatment with dry     needling or eccentric exercise's program realized of isolated form.   "
60110|NCT02498782|"     The hypothesis is to evaluate if the treatment with Fexinidazole will lead to a better     sustained clearance of the parasites at 6 months of follow-up when in comparison to placebo     in patients with chronic indeterminate CD.   "
60111|NCT02498769|"     In this study, the investigators aim to determine whether injecting botulinum toxin into     epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation     (POAF) after cardiac surgery. The investigators will test the hypothesis that botulinum toxin     injected into the epicardial fat pads reduces POAF and length of stay (LOS) without     increasing adverse events. This will be a prospective randomized trial of 130 patients     undergoing coronary artery bypass graft (CABG), valve surgery or CABG + valve surgery with     cardiopulmonary bypass. Patients will be randomized to receive either botulinum toxin (50     units per fat pad, n=65) or normal saline/placebo (1 mL per fat pad, n=65) injected into     epicardial fat pads. All patients will receive standardized anesthetic, surgical, and     post-surgical care. The primary outcome in this study will be time to occurrence of     in-hospital POAF. Based on previous work and a pilot trial showing a pronounced reduction     (relative risk reduction 77%) in POAF after injecting botulinum into the epicardial fat pads,     the investigators anticipate a significant reduction in the risk for POAF with epicardial     botulinum in this cohort, which includes valve surgery patients.   "
60112|NCT02498756|"     For investigators' current experimental clinical trial, patients are given 4 injections of     ipilimumab, given 3 weeks apart x 4 injections with or without cytokine-induced killer     therapy. Investigators propose to test this dual therapy in patients with melanoma who have     known stage I, metastatic melanoma. Investigators hypothesize that this form of combinatorial     immunotherapy will result in tumor stabilization or shrinkage, significant prolongation of     progression-free, disease-free or overall survival compared to the use of ipilimumab alone   "
60113|NCT02498743|"     The objective of this study is analyze the influence of TV entertainment in children less     than 3 years of age during echocardiography in order to achieve a complete and accurate test.      This is an experimental study in children with suspected congenital or acquired cardiac     disease. An examination room was prepared with a TV on the ceiling that was positioned in a     way that would provide unobstructed viewing for children during the echocardiography     procedure.   "
60114|NCT02498730|"     Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity     interval training compared to moderate intensity (same total work) on reducing the symptoms     of bipolar disorder, cortical changes, as well as on the VO2max. In addition, the     investigators will establish what influence of gain to VO2max has on reducing symptoms.   "
60115|NCT02498717|"     This study will examine the initial efficacy and cost-effectiveness of using the     cryocompression therapy model both pre-operatively and post-operatively in patients that have     recently suffered a traumatic calcaneus or ankle fracture compared to the standard     pre-operative RICE therapy procedures.   "
60116|NCT02498704|"     The purposes of this double-blinded, randomized controlled trial are (1) to determine if the     addition of trigger point dry needling (TDN) to a standard stretching program results in     greater improvements in hamstring flexibility versus stretching alone in a population with     atraumatic knee pain; (2) measure length of time that flexibility gains are maintained, (3)     assess resulting movement mechanics and (4) assess patient reported changes in pain. Findings     will potentially lead to insights as to the benefit of applying this intervention to     additional body regions.   "
60117|NCT02498691|"     Endometriosis is a benign gynecological disease, characterized by the presence of     endometrium-like tissue outside the uterine cavity that affect up to 10-15% of women in     reproductive age worldwide, with an extensive impact on women's wellbeing and their     reproductive life. Endometriosis lesions are heterogeneous and three phenotypes of the     disease are well recognized and are fundamentally different from each other: superficial     peritoneal endometriosis (peritoneal implants), ovarian endometrioma (cyst ovarian     endometriosis), and deeply infiltrating endometriosis (invasive nodules greater than 5 mm).      The investigators performed a prospective multicenter comparative study to assess the     maternal and fetal risks related to endometriosis during pregnancy, regarding disease     phenotype, This study will evaluate with sufficient power the risk of prematurity and     obstetrical complications associated with endometriosis according to disease phenotype.      This study aims to provide new informations to pregnant women with endometriosis, guide the     monitoring of pregnancy, optimize management strategies based on the nature of complications     and ultimately to improve the health of women and their unborn child   "
60118|NCT02498678|"     The objective of this study is to assess the performance of acceleromyography as a method of     evaluation of muscle relaxation after application of tetanus stimulation to obtain stability     of responses before administration of neuromuscular blocking agents.   "
60125|NCT02498587|"     This is a multi-centre, prospective, short period incidence observational study of patients     in participating hospitals and intensive care units (ICUs) with SARI. The study period will     occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5     to 7-day cohort study in which patients meeting a SARI case-definition, who are newly     admitted to the hospitals / ICUs at participating sites, will be included in the study. The     study will be conducted in 20 to 40-hospital/ ICU-based research networks globally. All     clinical information and sample data will only be recorded if taken as part of the routine     clinical practice at each site and only fully anonymised and de-identified data will be     submitted centrally.      The primary aim of this study is to establishing a research response capability for a future     epidemic / pandemic through a global SARI observational study. The secondary aim of this     study is to investigate the descriptive epidemiology and microbiology profiles of patients     with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory     and Logistic (EARL) barriers to conducting pandemic research on a global level.   "
60126|NCT02498574|"     A promising form of enhancing brain function non-invasively involves stimulating the brain     using weak magnetic or electric currents. This method is becoming increasingly popular in     both clinical and commercial circles; a number of portable, at-home devices are available on     the commercial market for personal use. In this study, the investigators aim to determine     factors associated with the enhancement of cognitive and motor learning following     transcranial direct-current stimulation in healthy young adults. Understanding how     participants respond to brain stimulation is critical to maximizing the effectiveness of     stimulation and determining its potential as a performance-enhancing aid for mental tasks.     Future developments of this study may also inform the capacity of brain stimulation to act as     non-drug alternative to treatment for cognitive decline.   "
60127|NCT02498561|"     Obesity may affect periodontal health by inducing gingival oxidative damage through increased     production in circulating reactive oxygen species (ROS). Previous studies have reported     decreased glutathione levels in patients with periodontitis when compared to healthy subjects     in gingival crevicular fluid (GCF), plasma and saliva. In the present study we hypothesized     that high ROS levels in circulation may decrease glutathione levels in the GCF,plasma and     saliva in obese patients with chronic periodontitis, whereas periodontal therapy could have     positive effects on glutathione levels.   "
60128|NCT02498548|"     This project will characterize lower extremity eccentric muscle function among individuals     who have undergone locomotor training after spinal cord injury and will evaluate the effect     of downhill training at moderate speeds - targeted to rehabilitation eccentric function of     the knee.   "
60129|NCT02498535|"     Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing     over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo     control arm.   "
60130|NCT02498522|"     The aim of this work is to study the effect of metformin use for reducing early pregnancy     loss in pregnant patients with Polycystic ovary syndrome (PCOS).   "
60131|NCT02498509|"     Clinical Trial to Evaluate the Efficacy and Safety of CKD-342   "
60132|NCT02498496|"     The purpose of this study is to assess whether administration of a bolus dose of MgSO4     (magnesium sulfate) plus standard therapy is superior to standard therapy alone for the     management of Acute Exacerbations of Chronic Pulmonary Obstructive Disease (AECOPD) in the     emergency department. The investigators hypothesize that MgSO4 causes faster recovery of the     bronchospasm, and a reduction of the dead space, translating to the following clinical     outcomes : less hospitalisation, lower length of stay (LOS), better composite outcome of     hospitalisation + LOS + readmission for AECOPD.   "
60133|NCT02498483|"     Infants do not routinely receive acetaminophen for pain control after circumcision. This     study will determine if acetaminophen is effective at controlling infant pain after     circumcision using nerve block and oral dextrose. Infants will undergo the routine     circumcision procedure , and half will be randomly selected to receive half acetaminophen     immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate,     respiratory rate, oxygen saturation), NIPS (the neonatal infant pain scale), and salivary     cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated     pain scoring system based on the appearance of the infant. A reduction in NIPS for those     infants who receive acetaminophen versus nothing will be our primary outcome to determine if     our study is significant.   "
60134|NCT02498470|"     The registry study is to obtain the state of the percutaneous coronary intervention state     treatment for coronary heart disease in the center of the first hospital of sun yat-sen     unversity in a real world.   "
60135|NCT02498457|"     This study aim to observe the preventive effect and the long term safety of low calcium     dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.   "
60155|NCT02498197|"     There is high prevalence of back pain and neck-shoulder pain among blue collar workers.     Physical excessive exposures such as heavy lifting or working with a bended or twisted back     are independent risk factors for back pain among workers in the construction industry.     Participatory ergonomic initiatives increase the success of interventions aimed at reducing     physical excessive exposures.      The objectives are in two phases to; 1) determine which work-tasks in selected job-groups     involve the highest load of the back and shoulders during a normal working day (using EMG,     Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical     workloads, drawing on information from objective measurements from phase 1.   "
60157|NCT02498171|"     This study is aimed at evaluating single short spinal technique as a form of labour analgesia     in a setting where more expensive and labor intensive techniques are not feasible.The study     will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl     vs intrathecal morphine+bupivacaine) through a randomized control trial.      The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl     or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients     experiencing normal labour.   "
60158|NCT02498158|"     Functional neural connectivity at rest of 3 groups (heat tolerant, heat intolerant and     healthy subjects) will be assessed using the anatomical and functional MRI scans and     compared.   "
77459|NCT02271971|"     The purpose of this study is to determine whether supplementation with oral vitamin D     (cholecalciferol) improves metabolic parameters in patients with moderate to severe     psoriasis.   "
60136|NCT02498444|"     The purpose of this study is to test the efficacy of treprostinil in the perioperative     non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube     drainage (in days).      The Fontan operation is performed for patients with single ventricle physiology as the final     palliation to create a series circulation, with passive systemic venous return to the     pulmonary arteries and the single ventricle solely providing systemic output.      Patients undergoing extracardiac Fontan tend to have elevation of Fontan pressures     immediately following the operation with inflammation from surgery requiring additional fluid     administration to maintain blood pressure. Increased Fontan pressures and fluid overload lead     to prolonged chest tube drainage.      The hypothesis is that treprostinil, a prostacyclin drug that dilates the pulmonary arteries,     will improve immediate postoperative Fontan pressures. Treprostinil is not FDA approved for     this use. Anecdotally and in a small case series, prostacyclin therapy has been shown to     assist in transitioning patients off nitric oxide. The investigators believe that this     improvement in hemodynamics will decrease duration of chest tube drainage resulting in a     shorter length of hospital stay.   "
60137|NCT02498431|"     The investigators aim to evaluate circulating irisin levels alterations in patients with     acute myocardial infraction and in patients with coronary artery disease subjected to     percutaneous coronary intervention.   "
60138|NCT02498418|"     The primary objective is to demonstrate rifaximin 200-mg tablets (test) and Xifaxan® 200 mg     tablets (reference ) are clinically bioequivalent with respect to the clinical cure rates     when administered 3 times a day (TID) for 3 days in subjects with travelers' diarrhea.   "
60139|NCT02498405|"     The primary objective of this study is to determine if the Smartphone electrocardiogram (ECG)     is an acceptable replacement for a standard ECG in the identification of ST Elevation     Myocardial Infarction (STEMI).      Toward this objective, this study involves the following:        -  Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone 12-lead          equivalent ECG on patients presenting with chest pain in which the STEMI protocol was          activated.        -  Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone 12-lead          equivalent ECG on patients presenting to the Emergency Department for evaluation of          chest pain, not necessarily presenting with STEMI.        -  Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who          are blinded to the initial clinical ECG readings, the type of ECG equipment used, and          the patient's clinical information.        -  Assess the operational feasibility of using the Smartphone to obtain 12-lead          equivalent ECG recordings in patients suspected to have STEMI, and        -  Determine the possibility of pooling the data obtained from this study with data from          other institutions conducting identical studies, and developing a future IRB-approved          protocol and statistical analysis plan to compare the sensitivity, specificity, positive          predictive value and the negative predictive power of the iPhone ECG, using a paired          standard 12-lead ECG as the gold standard.      There will be no therapeutic interventions. A single research-related procedure will be     required, i.e. an iPhone ECG. Effort will be made to ensure that the performance of this     procedure will not delay any treatment and/or diagnostic procedures that are part of usual or     specialized care that the patient requires. Effort will be made to enroll 1 STEMI patient for     every 2 non-STEMI patients.   "
60140|NCT02498392|"     The purpose of this study is to evaluate the efficacy and safety and tolerability of     JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who     have had inadequate response to treatment with a selective serotonin reuptake inhibitor     (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).   "
60141|NCT02498379|"     This study is designed to assess the safety, biodistribution and dosimetry of the novel     atherosclerotic imaging PET radiotracer, Cu[64]-25%-CANF-Comb.   "
60142|NCT02498366|"     In order to determine norm values for skeleton muscle disassembly due to physical exertion in     healthy and trained population, and developing a prediction test for approval for     rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of     different physical tests.   "
60143|NCT02498353|"     A randomized trial comparing weather preoperative short-course radiotherapy with local boost     is better than conventional preoperative short-course radiotherapy for local advanced rectal     cancer.   "
60144|NCT02498340|"     Glucose-6-phosphate dehydrogenase (G6PD) deficiency is prevalent and add a burden on families     in Egypt and Middle East due to lifelong diet restriction, non-fava beans diet is main food     for most families in the region and parents and doctors consider it as a prohibited food     whatever the genetic or clinical phenotypes. The effective management is avoiding a spectrum     of food and drugs causing oxidative stress. No data is available about the hazards of     consumption of non-fava beans diet.   "
60145|NCT02498327|"     Chronic Venous Insufficiency (CVI) is impaired venous return which results in lower limbs     symptoms that include pain, swelling and dermatologic changes. CVI is a condition that     affects both males and females, but is more prevalent in females due to the effect of     progesterone on vascular tissue resulting in the dilation of veins. The predisposing factors     for CVI include: female gender, long periods of standing, decreased physical activity,     obesity, poor nutrition, metabolic syndrome, tight and restrictive clothing as well as     advanced age, constipation, pregnancy and ascites. Conventional treatment may involve     surgery, compression stockings, laser therapy, sclerotherapy and venoactive drugs, which are     aimed at improving the appearance of varicose veins and decreasing pain and swelling.      The combination of Red Vine, Butcher's Broom, Horse Chestnut and Vitamin B6 is an over-the     counter herbal preparation, which is used to treat the symptoms associated with CVI. Studies     done on each of the preparation's individual constituents demonstrate their efficacy in     improving blood circulation, thereby alleviating symptoms associated with venous stasis. The     individual extracts improve venous tone and blood circulation, however there are no studies     on the combined effect of these individual ingredients and their efficacy on the quality of     life of females affected by CVI.      The aim of this study is to determine the efficacy of a combination of Red Vine Leaf extract,     Butcher's Broom, Horse Chestnut and Vitamin B6 on the quality of life in female participants     with CVI, using the Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20).   "
60154|NCT02498210|"     Poor ovarian response (POR) is one of the major therapeutic challenges in in vitro     fertilization. Several therapeutic approaches for POR have been explored; yet, a single     effective strategy has not yet been established. Recently, a live birth was reported after     ovarian cortex fragmentation and in vitro disruption of the Hippo signaling pathway and     activation of Akt signaling. During IVM procedure increased mechanical stimulation of the     ovarian cortex takes place. , with the consequent disruption of the Hippo signaling pathway.     Our aim is to investigate whether the mechanical manipulation and triggering of ovarian     cortex caused by IVM can cause ovarian follicular activation and recruitment by the     mechanisms mentioned above. Thus stimulation in the following regular IVF cycle will result     in improved ovarian response and increased oocytes yield   "
60156|NCT02498184|"     This is a double-blinded, randomized, controlled study on the effect of perioperative     acupuncture on pain after third molar extraction.   "
60146|NCT02498314|"     In orthopaedic manual therapy translatoric grades of movement are used to determine the     intensity of force applied during the mobilization. Different clinical effects are described     for each translatoric grade of movement but there are not published studies evaluating these     clinical effects.      The objective of this trial is to determine if force magnitude during hip traction in resting     position affects immediate and short-term outcomes (pain, physical function, hip muscle     length and hip range of motion) in patients with hip osteoarthritis. For this purpose,     investigators conduct a randomized clinical trial, double-blind (patient and physical     therapist examiner). Participants entering the study were randomized into 1 of 3 treatment     groups: grade I- grade IISZ mobilization, grade IITZ mobilization or grade III mobilization.     Participants attend three sessions on alternate days (monday, wednesday, friday) and at the     same hour. Measurements are taken prior to treatment, immediately after each session     treatment.      The participants are recruited from physiotherapy groups or referred by general practitioners     and orthopedic surgeons.      Participants were assigned to 1 of the 3 study groups through concealed allocation (sealed     envelopes) and independent blocked randomization, using a random number generator.      One physical therapist enroll patients in the study, while an independent research assistant     performed the randomization and prepared the sealed envelopes, which are opened after     baseline data collection by the physiotherapist performing the treatments. Participants are     treated in a private treatment area and have no knowledge of treatments received by other     participants.      A second experienced orthopaedic manual therapist applies the standardized hip traction     mobilization in resting position at either level of force, during 10 minutes. This amount of     mobilization is consistent with clinical practice and previous studies in osteoarthritis     patients.      Two physiotherapists (third and fourth) with 5 years of experience, who were blinded to     participant group, performed all measurements.The outcome measures are pain, physical     function, hip muscle length and hip passive range of motion. Pain is registered with visual     analogic scale (VAS), Pressure Pain Threshold ( PPT) and WOMAC pain subscale. Physical     function is registered using Timed Up & Go test (TUG), the 20-Meter Walking Test (20MWT) and     the physical function subscale of WOMAC index. The hip muscle length is measured using Ely´s     test, Active Knee Extension test and modified Ober´s test. The passive hip range of motion is     measured using inclinometer or goniometer.   "
60147|NCT02498301|"     The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin     chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed     setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial     flora and antimicrobial resistance, and obtain parameter estimates to inform a     cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study     will be used to develop management guidelines for the prevention of TD among deployed (United     States (US) and United Kingdom (UK) military personnel.      The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial     among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once     daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.      For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US     and UK) deploying/traveling overseas will be recruited prior to travel to participate and     will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible     and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550     mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed.     Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to     6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return     to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be     obtained before, during if available and after deployment/chemoprophylaxis.   "
60148|NCT02498288|"     This is an open-label, crossover, randomized, single dose, three treatments, three periods     and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin.     Bioequivalence will be compared between the reference medication one (T1) vs the test     medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3):     (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they     are bioequivalent.   "
60149|NCT02498275|"     This is an exploratory study to characterize the ex vivo immune response to RO6871765 or     RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy     volunteers and chronic hepatitis B (CHB) patients.   "
60150|NCT02498262|"     Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and     Placement (VR4VR) is a project that incorporates Virtual Reality into job training to     increase job opportunities for people who have physical or mental disabilities. The     investigators are using Virtual Reality and robotics for job evaluation, training and     placement of people with disabilities. The investigators' goal is to assess and train people     in a safe, adaptable, and fun virtual environment similar to a video game.      This is an interventional study with three target populations: autism spectrum disorder,     traumatic brain injury, and severe mobility and manipulation impairments. The prototype     system allows for a wide range of environments with the vocational evaluator easily     controlling the virtual experience, while the job seekers interact realistically.   "
60151|NCT02498249|"     The aim of the present study is to assess the immediate effect of irradiation with low level     laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the     amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients     with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study.     Each subject will receive two forms of treatment in random order: a single session of LLLT     and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out     period will be respected between sessions. Surface electromyography will be used to determine     nerve conduction velocity and activity in the upper trapezius muscles before and after     treatment. The outcome measures will be determined by a numerical pain rating scale.     Comparisons before and after irradiation with LLLT will determine the activity of the upper     trapezius muscles and the level of pain. The data will be submitted to statistical tests     considering a p-value of p < 0.05.   "
60152|NCT02498236|"     This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two     proposed measures of target engagement in brain. The targets are (1) the suppression of a     particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially     relevant form of motion and (2) pupil dilation will subjects identify faces showing different     emotions.   "
60153|NCT02498223|"     In order to reduce the physiological and biomechanical loads that the soldiers are exposed     to, the investigators want to examine new approaches for distributing the carried loads     according to measurements that are specific for each soldier (body composition and aerobic     capacity). A functional index (LCI=load carriage index) will provide the commander a tool for     better decisions in distributing the same total load among the same number of soldiers,     according to each soldier's ability.   "
60182|NCT02497846|"     The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL®     PureSense Redensity [I] injection using MicronJet® needle in the treatment of crow's feet     wrinkles.      It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with     an interval of 3 weeks. The last visit will be performed 3 weeks after the last injection.      Only, one group of 15 healthy volunteers will be included.   "
60159|NCT02498145|"     This is a pilot human experimental study to evaluate whether the use of an e-cigarette     affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in     active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult     Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be     randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus     nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine     e-cigarette.   "
60160|NCT02498132|"     Elevated depressive symptomatology is a widespread public health concern and individuals with     elevated depressive symptoms most frequently report such symptoms to primary care physicians     (PCPs). PCPs have few evidence-based resources beyond antidepressant medication for treating     elevated depressive symptoms, which results in negative outcomes for their depressed     patients. Mobile technologies offer an ideal strategy to meet widespread treatment needs. The     purpose of the proposed project is to\ customize Behavioral Activation (BA), a     straightforward, empirically supported treatment for elevated depressive symptoms, for a     mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their     patients with elevated depressive symptoms.   "
60161|NCT02498119|"     The purpose of this study is to determine whether an increase in lipid bodies in leukocytes     will lead to an increase in eicosanoid production. The 2nd purpose is to determine if there     is a significant correlation between lipid body formation and enhanced generation of both     Lipoxygenase (LO) and COX derived eicosanoids. The 3rd purpose is, if lipid bodies are     involved in arachidonic acid (AA) metabolism, then AA present in these lipid rich structure     must be released by phospholipases and the free Arachidonic Acid (AA) must have access to the     eicosanoid forming enzyme. The fourth objective is to determine the compartmentalisation of     cPLA2 and MAP kinases including ERK1, ERK2, p85 and p38 are involved in AA liberation within     lipid bodies.   "
60162|NCT02498106|"     The overall goal of this study is to investigate whether the daily administration of     multivitamins, minerals and n-3 fatty acids will reduce aggression in long-term psychiatric     inpatients and will thereby reduce costs of care.   "
60163|NCT02498093|"     Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore     muscular strength or walking speed. Three-5 years after surgery patients are still not fully     rehabilitated. This study evaluates the effects of maximal strength training on the muscular     strength in leg press and abduction in patients undergoing THA. Aim of the study is to     increase the patients physical function through evidence-based rehabilitation in clinical     practice, with gradually less supervision.   "
60164|NCT02498080|"     Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering     peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage.     During the last decade, drug eluting balloons (DEB) were found to be an effective tool for     the treatment of atherosclerotic disease in several arterial districts. Aim of this study is     to compare results of DEB PTA versus standard PTA of infra-popliteal district in patients     with CLI, from a single-centre prospective randomized trial.   "
60165|NCT02498067|"     The investigators will develop a digital application (app)—rPlan dual protection (rPlan)—to     be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The     goal of this research is to develop the app and conduct a feasibility, acceptability and     effectiveness assessment of rPlan to examine improvement in dual method use, enhancement of     contraceptive adherence and continuation, increase of condom use and decrease of sexually     transmitted infection (STI) and human immunodeficiency virus(HIV) infection. The research     will consist of baseline activities as well as 6 week phone call and 12 week in-clinic survey     and STI test, as well as a retrospective chart review.   "
60166|NCT02498054|"     A single visit & single arm study in 80 subjects with diabetes to determine if a short     educational experience with a new blood glucose meter feature improves the ability of each     subject to better classify glucose results into acceptable glucose ranges.   "
60167|NCT02498041|"     This study evaluates the diagnostic accuracy, safety and acceptability of transnasal     endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised     trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be     randomised to receive either TNE or standard endoscopy followed by the other procedure.   "
60168|NCT02498028|"     The aim of this study is to examine the clinical outcome after anterior cervical     decompression and fusion, and cervical disc prostheses in general. Additionally these two     surgical methods for degenerative diseases of the cercival spine are analyzed comparatively     in order to see whether one procedure should be preferred.   "
60169|NCT02498015|"     A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid     substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with     genotype 1a infection or cirrhosis will receive 12 weeks of open-label     paritaprevir/ritonavir/ombitasvir and dasabuvir (3D), and twice-daily ribavirin.     Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label     3D. The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and     follow-up phase (96 weeks) to evaluate treatment response and reinfection.   "
60183|NCT02497833|"     The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity     and cholesterol efflux capacity in hypercholesterolemic subjects.   "
60184|NCT02497820|"     A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg     versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline     pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention     Programme (CaPP3).   "
60186|NCT02497794|"     This study is a randomised controlled trial that included 150 pregnant women undergoing     cesarean in Sisli Ethal Training and Research Hospital, Department of Obstetrics and     Gynecology, Istanbul, Turkey. It was carried out in the period from October 1, 2015 to     December 31, 2015. After operation, the participants are going to randomly assigned into two     groups by using cards. The patients are going to randomized into two groups by using a sealed     enveloped system.The patients in the study group, will chew one sugar less gum for 30 minutes     in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum.     All patients will note the time of first rumbling of the stomach, first feeling of hunger and     the first gas outlet.   "
60170|NCT02498002|"     Obesity is a global concern with links to conditions such as diabetes. Historically, these     conditions have been managed by reducing energy intake on a daily basis, which is often     hampered by low adherence rates and compensatory reductions in physical activity.     Intermittent fasting (IMF) has become popular as an alternative method of weight loss, where     periods of normal eating are punctuated by days of fasting. However, despite its popularity,     IMF is scarcely examined within the literature.      This study will examine the impact of IMF on energy balance and the associated health     outcomes relating to conditions such as diabetes. To achieve this, 36 lean adults and 36     overweight/obese adults will be recruited, excluding those with conditions which may be     adversely affected by fasting. Once enrolled, participants will complete a one month control     phase, incorporating 12 days of diet and activity monitoring, to ensure their weight is     stable before moving in to the intervention phase.      The intervention phase will begin with a lab protocol designed to examine body composition,     resting metabolic rate and metabolic responses to two successive meals. Once completed,     participants will be randomised to one of three diets which are listed below. Comparing the     changes seen with diets 1 and 2 will provide the first direct comparison of IMF against more     conventional strategies, while diet 3 will allow us to ascertain the role of weight loss in     mediating any effects of IMF.        1. Daily calorie restriction - Reduce energy intake by 25% on a daily basis        2. IMF with weight loss - Alternate between 24 hour cycles of fasting and feeding with 150%          of normal intake when feeding        3. IMF without weight loss - Alternate between 24 hour cycles of fasting and feeding with          200% of normal intake when feeding      All three diets will last for 20 consecutive days, with transitions between each 24 hour diet     cycle occurring at 15:00 each day to allow at least one main meal per day. When fasting,     participants will only be permitted water and black tea/coffee to eliminate energy intake.     Once again physical activity and diet will be monitored for 12 days during the intervention     to examine changes in energy expenditure and ensure compliance.      Having completed all 20 diet cycles participants will return to the laboratory to repeat the     protocol described earlier. Comparing these results against the values seen before the     intervention will then allow the effects of IMF to be identified and compared.   "
60171|NCT02497989|"     The purpose of this study is to evaluate the impact of two interventions - Inter-Personal     Communication [IPC] and Dedicated Service Outlets [DSOs] - in recruiting men aged 25-39 years     for Voluntary Medical Male Circumcision (VMMC) services.   "
60172|NCT02497976|"     Randomized, double-blind, placebo controlled study evaluating the efficacy of certolizumab     pegol in the treatment of interstitial cystitis/ bladder pain syndrome.   "
60173|NCT02497963|"     The purpose of this study is to determine the efficacy and safety of tubularized incised     plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary     hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of     glans ≤ 14 mm, and urethral plate depth shallow o moderate.   "
60174|NCT02497950|"     Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.   "
60175|NCT02497937|"     This study is a single centre, randomised, double-blind, sponsor-unblinded,     placebo-controlled, 2 by 2 crossover study in adults with heart failure. In blocking the     TRPV4 ion channel and reducing pulmonary interstitial fluid, GSK2798745 may improve pulmonary     function, respiration, and gas exchange as well as sleep-disordered breathing in patients     with heart failure. Therefore, the current study is designed to investigate the effect of     repeat administration of GSK2798745 on pulmonary gas exchange and pulmonary function.      A sufficient number of subjects with heart failure will be enrolled so that 12 subjects     complete the two study periods and critical assessments. Subjects will be randomised to     receive either GSK2798745 or placebo once daily for a period of 7 days in one treatment     period and alternate study medication in the second treatment period. Both the treatment     periods will be separated by a washout period of at least 14-days.      This study will consist of a Screening visit within 14 days of the start of Period I and two     treatment periods wherein eligible subjects will be randomised to one of the two treatment     sequences, a follow-up visit approximately 2 weeks after the completion of second study     period. The total duration of the study is approximately 8 weeks from screening to follow-up     visit.   "
60176|NCT02497924|"     This study will provide information regarding the metabolic pathway of GBT440, the need for     evaluation of potential drug-drug interactions, and the need for studies in special     populations. The administration of radiolabeled drug is necessary to fully characterize the     rates and routes of elimination of GBT440, providing further quantitative information on the     disposition of GBT440. The results from this study will permit a comprehensive comparison     between animal and human routes of elimination and metabolic profiles of GBT440.   "
60177|NCT02497911|"     The study is a prospective randomized controlled trial comparing intraarticular catheters and     adductor canal catheters for postoperative analgesia following a primary Total Knee     Arthroplasty (TKA).   "
60178|NCT02497898|"     The purpose of this study is to study the safety and efficacy of chemotherapy usage followed     by CIK transfusion in refractory and/or chemoresistant lymphomas.   "
60179|NCT02497885|"     The investigators aim to do serosurvey of healthcare-personnel who had participated in     treatment of confirmed patients of Middle-East respiratory syndrome. The investigators     collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and     will collect the post-exposure serum from about 25-30 centers in which confirmed MERS     patients had been treated.      The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy     healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators     will subdivided the seroprevalence according to the degree of exposure and preparedness of     personal protective equipment.   "
60180|NCT02497872|"     BACKGROUND: The most common complication of endoscopic retrograde cholangiopancreatography     (ERCP) is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. However,     early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a     preventive measure has not been compared to other preventive measures, such as pancreatic     duct stent placement.      AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent     placement in high-risk subjects undergoing ERCP.      MATERIALS AND METHODS: This is a single-blinded, randomized trial that took place in two     tertiary referral centers in Buenos Aires. ERCP subjects shall present at least one of the     following risk factors: female sex, age less than 40 years, clinical suspicion of Sphincter     of Oddi dysfunction, previous pancreatitis, common bile duct diameter of less than 8 mm. Only     those who present a difficult biliary cannulation shall be randomized into two groups: those     who receive early precut sphincterotomy or those in whom persistency of biliary cannulation     is intended with subsequent pancreatic duct stent placement after cholangiography is     achieved. The incidence of post-ERCP pancreatitis as well as other complications shall be     compared.   "
60181|NCT02497859|"     The experiments in this study will assess if while following a reduced energy diet, eating a     breakfast with higher protein quality will enhance weight loss compared to another breakfast     with lower protein quality, but matched for energy density and macronutrient composition.   "
60185|NCT02497807|"     The purpose of this study is to characterize the functional and anatomical connectivity     changes in Tourette syndrome and its relation with iron deficiency.   "
60188|NCT02497768|"     The investigators want to understand how oral processing (chewing) of nuts affects particle     size and the presence of lipid (fat) on the cut surfaces.      The main objective of the study is to:      Measure the size of nut particles that have been chewed sufficiently to be swallowed.      The secondary objective of this study is to:      Measure any changes in lipid content due to chewing and compare it to a prediction from a     theoretical model.      The investigators have developed a theoretical model for determining the release of nutrients     from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate     the amount of lipid released from chewed almonds. The model shows that only about 10% of the     lipid is immediately released. The investigators require information on the particle size     distribution (number of particles of each size) for other chewed nuts to calculate the amount     of lipid released for other nuts. This will allow us to check the validity of our model for     other foods.   "
60189|NCT02497755|"     This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care     patients receiving treatment for depression or anxiety delivered in an integrated primary     care-based behavioral health program.   "
60190|NCT02497742|"     Twice daily basic metabolic panel's or labs are common practice at Vanderbilt University     Medical Center. However, it is unclear how often the second BMP each day is acted on. the     investigators project aims to answer a few fundamental questions about the need for twice     daily labs in patients hospitalized with acute/subacute-decompensated congestive heart     failure who are being actively diuresed.   "
60191|NCT02497729|"     The use of a written, pre-procedure checklist and positioning the patient with the head of     the bed elevated have been proposed as interventions capable of preventing complications     during non-elective intubation and are used intermittently in routine care -- however neither     have been examined in a prospective trial.   "
60192|NCT02497716|"     To characterize the pharmacokinetic profile of rivaroxaban administered as granules for     suspension formulation and to document safety and tolerability   "
60193|NCT02497703|"     An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This     robotic system has been developed to facilitate functional motor recovery by practices     walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank     and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the     gait pattern from the stroke patients and assist the walking and control the knee angle. The     clinical trial will use repeated measurements to evaluate the effectiveness of the robotic     knee system in gait rehabilitation post stroke.   "
60194|NCT02497690|"     This study will assess the effectiveness of post-cochlear implant or hearing aid fitting     Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.   "
60195|NCT02497677|"     Infant mental health is a significant public health issue as early adversity and expose to     childhood stress has life-long consequences for the affected children. Helping families at     risk correct their adverse effects on the infant has the potential to halt a negative spiral     effect where vulnerable parents fail to cope with an at-risk child - which in turn, adds to     the child's vulnerability, negatively affects the parents, and so forth. Over a four year     period, an estimated 17.600 dyads will be screened in the City of Copenhagen using     standardized screening instruments in detecting infant social withdrawal (ADBB) and maternal     postnatal depression (EPDS). A sample of 314 eligible parent(s) will enter into a clinical,     randomized control trial to test the efficacy of an 8 week group counseling program, Circle     of Security Parenting (COS-P) compared to Care as Usual(CAU) in enhancing maternal     sensitivity, child attachment and cognitive development. CIMHP is the first large-scale     randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity,     child attachment and cognitive development in Denmark. Results will provide evidence     regarding the efficacy of an American short term indicated parenting group program when     implemented in a Scandinavian country.   "
60196|NCT02497664|"     Neo-adjuvant chemoradiotherapy (neo-CRT) is increasingly applied in the curative treatment of     esophageal cancer, with the aim to downstage the tumor, to increase the rate of radical     resections, and consequently to improve the survival rates. Due to improved survival, it will     become increasingly important to minimize the radiation-induced toxicity among long-term     survivors.      In the management of locally advanced non small cell lung cancer (NSCLC), radiotherapy is the     standard treatment modality. However, the dose that can be safely applied to the tumour is     limited by the risk of cardiac and pulmonary complications, which even led to decreased     survival in a randomised study, when a higher tumor dose was administered [1].      Radiation induced pulmonary and cardiac toxicity are the most important late side effects     after thoracic radiotherapy [2-4].      The aim of this study is to reduce the radiation dose of heart (and lungs) in order to reduce     the toxicity risk.      In recent years, the active breathing control (ABC) technique has been introduced in the     radiotherapy for left sided breast cancer patients, to minimize the radiation dose to the     heart. These patients are irradiated in the inspiration phase, in which the distance between     the heart and the breast is largest, while the lungs extend.      Breath hold might also be beneficial for radiotherapy of esophageal and lung tumors. For     these patients the expiratory phase might theoretically be more beneficial to reduce the     heart dose. However, the inspiration phase might be better for the dose to the lungs, which     consequently allows cardiac dose reduction.   "
60197|NCT02497651|"     The study aims to evaluate the effect of smoking on postprandial responses such as plasma     glucose, secretion of gut - and pancreatic hormones and gastric emptying in healthy, heavy     smoking men.   "
60199|NCT02497625|"     This study aims to evaluate the effectiveness of minimal intervention and therapeutic     alliance in pain, specific and general disability, global perceived effect, empathy,     credibility and expectation of improvement in patients with chronic non-specific low back     pain   "
60200|NCT02497612|"     Primary Objective:      To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) is an     efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.      Secondary Objectives:      To evaluate the efficacy of OZ439 (Artefenomel)/FQ (Ferroquine):        -  To determine the incidence of recrudescence and re-infection.        -  To determine the time to relief of fever and parasite clearance.      To evaluate the safety and tolerability of OZ439 (Artefenomel)/FQ (Ferroquine).      To evaluate the pharmacokinetics of OZ439 (Artefenomel)/FQ (Ferroquine).      To explore in vitro drug resistance of P. falciparum infecting patients >14 years old in     Vietnamese sites.   "
60201|NCT02497599|"     Intraoperative tumor localization and resection can be enhanced using intraoperative     fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic     anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore     Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality     image-guided surgery in RCC.      The aim of this study is to assess the feasibility and safety of intraoperative dual-modality     imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.   "
60202|NCT02497586|"     Lung cancer is commonly characterised either with a surgical procedure or by taking a tissue     sample with a needle. Unfortunately, these invasive approaches may be unsafe in many patients     with lung cancer, who often have co-existing illnesses such as emphysema.      Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of     assessing tumour function by measuring concentrations of chemicals (metabolites) within the     abnormal tissue. It is a well-established technique in imaging brain cancers. It has also     been more recently studied in assessing prostate, liver and heart. There has been very little     exploration of the potential role of MRS in lung cancer.      The proposed feasibility study will recruit 15 patients with proven lung cancer to undergo an     MRS scan. The reliability of the technique for metabolite measurement will be determined by     comparing repeated scans from the same region in the same tumour. Further scans from     different regions in the same tumour, normal lung around the tumour and tumour regions in     different patients will be used to look for any patterns in the cancer metabolites which may     indicate avenues for potential future research.   "
60203|NCT02497573|"     Around 50% of patients with locally advanced H&N cancer fail to achieve loco-regional     control. Currently it cannot be predicted, during treatment, who will fall into this group of     non-responders.      This study is designed to assess the value of DW MRI as a predictive biomarker of response to     radiotherapy in intermediate and high risk OPSCC.   "
60204|NCT02497560|"     This is a randomized, masked, placebo controlled study to assess the effect on a nutritional     dietary supplement on menopausal signs and symptoms in perimenopausal women.   "
60205|NCT02497547|"     Up to 50% of postmenopausal women frequently suffer from atrophic vaginitis or vaginal     atrophy with symptoms including vaginal dryness, irritation, burning, itching or discomfort.     Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier,     and less elastic due to lack of estrogen. In addition, vaginal atrophy is associated with an     increased pH, which creates an environment more susceptible to infections.      Menopausal hormone therapy is a common treatment for vaginal atrophy. However, menopausal     hormone therapy has been shown to coincide with an increased incidence of breast cancer,     heart attack and stroke. Some women experience adverse reactions such as uterine bleeding,     perineal pain, and breast pain with menopausal hormone therapy. Many women are also reluctant     to initiate estrogen treatment, due to a general negative view of menopausal hormone therapy     in the society. There are also many contraindicated conditions like undiagnosed vaginal     bleeding, thromboembolic disease, breast cancer, other estrogen-sensitive cancers, or liver     disease. Women suffering from vaginal atrophy and presenting with these conditions have     extremely limited options for effective therapy.      Oxytocin is a peptide hormone, normally released into the circulation via the pituitary.     Oxytocin has been shown in vitro to exert positive effects on the proliferation of human     vaginal mucosal cells from postmenopausal women. Local application of oxytocin, in the form     of a vaginal gel, Vagitocin, has been investigated in previous studies on postmenopausal     women, as a new effective and safe option for the treatment of vaginal atrophy. Vagitocin     appeared to reverse the manifestation of vaginal atrophy by stimulating vaginal mucosal     growth, reducing symptoms of vaginal atrophy and increasing the patients' wellbeing and     quality of life. Overall, treatment with Vagitocin was safe and well tolerated by the     subjects in the studies.      In this study, the clinical efficacy of Vagitocin as a potential treatment for postmenopausal     women suffering from moderate to severe symptoms of vaginal atrophy, vaginal     irritation/itching and vaginal discomfort and/or pain associated with sexual activity will be     explored. In addition, the dose relationship and lowest effective dose of Vagitocin will be     investigated.   "
60206|NCT02497534|"     The purpose of this project is to characterize measures of cardiac performance and     neuromuscular physiology in FA patients using novel techniques, including echocardiography     and magnetic resonance imaging (MRI), metabolic exercise testing, and neurophysiological     outcomes.   "
60207|NCT02497521|"     The German ADPKD Tolvaptan Treatment Registry is a prospective, observational, multicentric     study of patients suffering from ADPKD that are considered for tolvaptan treatment. All ADPKD     patients that are evaluated for treatment indication, or that are planned to be treated with     tolvaptan, or that are already treated with tolvaptan are eligible. This registry is designed     to provide real-world data on treatment management of patients with ADPKD.   "
60208|NCT02497508|"     This is a prospective, single arm, phase II trial in previously treated patients with MPM who     are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies.     Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection.      The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks     when compared to DCR of patients treated with best supportive care based on historical     controls.   "
60221|NCT02497326|"     Pain Associated with partial thickness burns (PTB) is very severe and distressing for the     patients.Topical conventional treatment of superficial PTB wounds includes application of     polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are     treated with silvazine cream twice a day and prepared for grafting if not healed within 3     weeks. Existing conventional therapy is un-comfortable and expensive for the patients. Search     continues for a reliable, safe, cheap and effective treatment of burn.Topical use of heparin     has been found effective in reducing pain associated with burn wounds. More over use of     heparin topically in burn patients is easy to perform and cheap but at the moment, evidence     of its effectiveness is weak. Current study is being conducted to verify clinical     effectiveness of use of heparin in 2nd degree burns by comparing it with topical conventional     treatment.   "
60568|NCT02492776|"     The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of two     gefapixant (AF-219) formulations; to assess the effect of omeprazole on the multiple dose PK     of two gefapixant formulations; and, to assess the safety and tolerability of gefapixant.   "
60313|NCT02496117|"     Study design: Investigator initiated, single centre, feasibility study      Main objectives are twofold:        1. To investigate the feasibility of RNS in patients with therapy resistant hypertension,          which is assessing the functional distribution of renal nerves using 3D imaging and          differential pacing modalities.        2. To investigate the blood pressure responses and cardiac excitable properties to RNS, and          subsequently perform a RDN procedure, guided by 3D mapping by two different techniques          e.g. RNS-checked RDN and RNS-guided RDN procedures.      Study population: 40 patients (18 - 80 yr old)   "
60701|NCT02491034|"     The purpose of this project is to implement a Depression Education Intervention (DEI)     designed to increase disease literacy, and dispel myths about depression and its treatment     among Hispanic patients thus reducing stigma and increasing treatment engagement. This     project will be conducted at one community health center whose patient population is majority     Hispanic.   "
60209|NCT02497495|"     Introduction: immersion cold water is a recuperative strategy commonly used, however, are not     yet fully understood the real effects of this technique on specific conditions. Objective: To     analyze and to compare the effects of the immersion cold water during the intense     post-exercise recovery, using different times and temperatures on biological, clinical and     metabolic variables. Method: 105 male subjects were divided into five groups: one control     group (CG) and four recoveries (G1: 5' at 9±1 degrees Celsius; G2: 5' at 14±1 degrees     Celsius; G3: 15' at 9±1 degrees Celsius; G4: 15' at 14±1 degrees Celsius). The volunteers     were submitted an exhaustion protocol that consisted of a program of jumps and the Wingate     test. Immediately after the exhaustion protocol, volunteers were directed to a tank with     water and ice, which were immersed up to the height of the anterior superior iliac spine to     the recovery procedure, during which blood samples were collected for later analysis lactate     and creatine kinase (CK). Variables were collected prior to the exercise, 24, 48, 72 and 96     hours after the end of it. Furthermore, the perception of pain and recovery of the lower     limbs were also collected at specific moments by means respectively of the Likert scale of     perceived effort and visual analogue scale pain. Appropriate statistical analysis was used to     compare the groups and the moments, considering the 5% level of significance.   "
60210|NCT02497469|"     The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous     (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment     period.   "
60211|NCT02497456|"     The purpose of this study is to evaluate the impact of follow-up counselling after HIV     diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to     pre-antiretroviral therapy (pre-ART) care in Uganda.   "
60212|NCT02497443|"     • The goal of this study was to evaluate the safety and efficacy of autologous MSC     application for the therapy of drug-resistant symptomatic epilepsy. Adult (18-60 years old)     patients (pts) of both sexes suffering from refractory epilepsy with frequent (>5 events per     month) seizures were included in this study. The pts were randomized to the standard     treatment with anti-epileptic drugs (control group, 30 pts) or anti-epileptic drugs plus     autologous mesenchymal stem cells (MSCs) (study group, 30 pts). The pts in the study group     received one intravenous injection of ex vivo expanded MSCs (40-101 x 106 cells) and one     subsequent endolumbal injection of neuroinduced MSCs (2.7 - 8.0 x 106 cells). Both the     unfavorable reactions to MSC infusions and the clinical effects, including complications,     were examined. The unfavorable reactions to the MSC injections included local pain or     hemorrhage at the site of injection and systemic reactions of the central nervous system     (CNS; i.e., hyperthermia, fatigue, and myalgia).The possible beneficial effects of therapy in     the two groups of pts were examined based on clinical observations and electroencephalography     measurements (prior and 12 months after the application of the MSC-based therapy). To     determine potential changes in disease progression, the signs of cognitive impairment,     behavioral disorders, and particularly, changes in seizure character and frequency were     evaluated using the National Hospital Scale of Seizure Severity. The main points of disease     monitoring were yes or no responses (to therapy), seizure frequency (per month), and     remission of disease. Electroencephalography (EEG) recordings were performed to evaluate     electrical alpha, beta, theta and delta waves based on standard and additional criteria. The     paroxismality index, the peak frequency of EEG activity, the index of slow activity, and the     summarized points of EEG pathology signs were calculated for each patient. All assessments     were performed for the pts in the control and study groups, and the obtained data were     compared to identify the potential differences between the two pts groups. Therapy was     terminated when immediate unfavorable reactions to the MSC injections were observed. The     final observation of each patient included clinical and EEG assessments at the time point of     12 months (or more) after the application of the MSC-based therapy.   "
60213|NCT02497430|"     The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B     Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs     obtained from pregnant women between 35 - 37 weeks gestation.   "
60214|NCT02497417|"     The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test     for the direct detection of C. difficile nucleic acid in stool specimens.   "
60215|NCT02497404|"     The purpose of this study is to determine whether 5-Azacytidine priming before the     conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an     effective treatment for high risk myeloid malignancies in complete remission (CR).   "
60216|NCT02497391|"     The purpose of this study is to determine if there is any difference in the way the body     handles 3 types of evacetrapib tablets with different particle sizes. Information about any     side effects will also be collected. This study will consist of 3 study periods. Participants     will be dosed 3 times during the entire study. Each study period will consist of an inpatient     stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing     (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily     for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks     from first dose to end of study. Screening will take place within 28 days prior to the first     dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.   "
60217|NCT02497378|"     The purpose of this study is to evaluate the tolerability and safety of JNJ-54767414     (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese     participants with relapsed (the return of a medical problem) or refractory (not responding to     treatment) multiple myeloma.   "
60218|NCT02497365|"     This is a study comparing a new treatment for bacterial keratitis (also known as corneal     ulcers) with the current standard of care. It is a randomized trial, and the investigators     plan to test whether besifloxacin (a new antibiotic) in comparison to the current standard of     treatment, fortified antibiotic drops (cefazolin and tobramycin).   "
60219|NCT02497352|"     To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and     anthropocentric measurements in subjects with metabolic syndrome, in a randomized,     open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received     30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both     groups will be advised to follow an energy balanced diet and physical activity     recommendations. Parameters related to metabolic syndrome will be measured at the baseline     and at the end of the study.   "
60220|NCT02497339|"     This study has the following objectives:        1. To raise the awareness of female smokers about the harmfulness of tobacco towards their          life issues        2. To encourage female smokers to stop using tobacco        3. To assess the effectiveness of mindfulness approach for smoking cessation in women      We will use cluster randomisation. About 40 companies (5 smokers / company) involved in the     study will be matched on the company characteristics (e.g. company size, the industry the     company belongs to). Using random generator in Excel, random number will be first generated     to each pair i.e. there will be 1-40 random numbers. For each pair, the two companies will be     randomly assigned to 0 or 1. Companies who are assigned to 1 will be allocated to     intervention . Interviewers (assessors) in the follow-ups will not be involved in the     randomization process and be totally blinded to the group assignment (allocation     concealment).      Invitation letter will be sent to beauty and retail industries or other women-related     industries by Lok Sin Tong. Health talks on smoking and its hazard will deliver to each     company. For those who join the workshops after the health talks will fill in pre- and post-     workshop questionnaires (Appendix 4-5). Women who attend the health talk will be recruited on     site. Women will be screened by the criteria of eligibility form (Appendix 1) and all     eligible women smokers will be asked to sign on informed consents (Appendix 2, 3) before they     participate in the programs. After they consent to participate, they will fill in a baseline     questionnaire (Appendix 6), and will be assigned to intervention or control group according     to the allocation of their company. Some of the eligible women may miss the health talks and     directly join the intervention program, because of this situation the intervention group will     be further divided into Group A and B: women in Group A will attend health talks and     intervention program, women in Group B will only attend intervention program.      Intervention group (Mindfulness Smoking cessation program): Women in intervention group will     be provided 2 sessions mindfulness training within 2 weeks. Each session will last for 2     hours with 8-20 participants. For mindfulness training, it aims to understand women smokers'     own life planning, stressors and their correlation with smoking; to help women smokers sit     with negative affect and alleviate stress through mindfulness; to educate women smokers gain     the self-control and replace the smoking habit; to teach women smokers how to prevent craving     and relapse. The tentative agenda is shown below:      Session 1 (Introductory) Contents        1. Pre-questionnaire        2. Introducing mindfulness and managing craving with mindfulness        3. Understanding the components of craving and its management             -  The relationship between habitual response and learned association             -  The physiological and psychological withdrawal symptoms        4. Mindfulness yoga practices      Responsible person* Smoking Cessation Program in Workplace (SCPW) staff & Yoga teacher      Session 2 (Advanced)      Contents        1. Knowledge about impacts of smoking on women's health        2. Recapture the management of craving through mindfulness        3. Mindfulness exercises        4. Mindfulness yoga practices      Responsible person* SCPW staff & Yoga teacher      * SCPW staff would be responsible for the whole session except for the part stress reduction     and self-control through mindfulness yoga. It would be held by the yoga teacher.      Control group (Self-help smoking cessation booklet): Only the self-help booklet related to     quitting will be provided to the participants.      Evaluation: 1-month telephone interviews will be conducted for control group at 1- (Appendix     97) and 6-month follow-ups will be conducted for both groups (after the last interventions)     by trained interviewers (blinded to the group assignment). Participants who have reported     abstinence in past 7 days from smoking at 6-month follow-ups will undergo a non-biochemical     validation to check their quitting status. They will be invited to have biochemical     validation tests (saliva cotinine test and exhaled CO test) at 6-month follow-up.      In-depth face-to-face interview will be conducted by trained interviewers in 10 randomly     selected participants in each group (in total 20 participants) to better understand their     quitting process, quitting difficulty, and their own feeling and experience in the project.   "
60270|NCT02496689|"     This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene     mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme     needed to harden bone. The purpose of this study is to provide access to treatment in a     disease where no approved treatment exists. This is an experimental treatment provided under     specific treatment guidelines in which safety endpoints will be collected.   "
60491|NCT02494154|"     This study evaluates the work of breathing among patients under various conditions of     treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with     respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is     a cross over of four treatment periods with different flow settings.   "
60222|NCT02497313|"     Accumulating evidence suggests that bile acids in our intestines may constitute essential     components in the complex mechanisms regulating gut hormone secretion and glucose     homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile     acids can lead to changes in gut hormone secretion and consequently affect glucose     homeostasis.      The current study is a human interventional randomized controlled cross-over study including     four study days for each participant. Metformin will be applied as a tool to reduce bile acid     reuptake in the small intestine; thereby increasing bile acid concentration in the more     distal parts of the gut where GLP-1-secreting L cell are abundant. Interestingly, metformin     has been shown to reduce the active reabsorption of bile acids in the ileum and cause     increased faecal elimination of bile acids. Clinical data has suggested that metformin causes     an increase in the postprandial secretion of GLP-1 in humans including patients with type 2     diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder     contraction and emptying. The aim is to examine how (and if) modification of bile acid     reabsorption can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose     homeostasis in patients with type 2 diabetes.      The investigators hypothesize that higher luminal concentrations of bile acids in the distal     gut will elicit changes in gut hormone secretion. The current study will help to clarify this     hypothesis and improve our general understanding of the association between bile acid     circulation and signalling, gut hormone secretion and glucose metabolism.   "
60223|NCT02497300|"     Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the     progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have     been shown to improve endothelial function, as well as decrease CV mortality and proteinuria.     The specific biochemical pathways that produce these pharmacological effects for MR     antagonists, however, are poorly understood. This study investigates the effect of MR     antagonism on endothelial function in patients with moderate (stage III) CKD using a     randomized, controlled trial. Three specific aims are proposed: Aim 1: To determine if     spironolactone improves endothelial function as compared to amiloride in patients with stage     III CKD; Aim 2: To determine if oxidative stress is associated with changes in endothelial     function by spironolactone compared to amiloride in patients with stage III CKD; and Aim 3:     To determine if endothelial dysfunction contributes to albuminuria in patients with stage III     CKD. The clinical relevance is to improve understanding of the mechanisms of kidney function     decline in CKD in order to develop interventions to delay or prevent dialysis, which would     translate into alleviating patient suffering, caregiver burden, and health care costs.   "
60224|NCT02497287|"     The purpose of this open-label, multicenter study is to assess the long term safety and     efficacy of intranasal esketamine plus an oral antidepressant in participants with     treatment-resistant depression (TRD).   "
60225|NCT02497274|"     The purpose of the protocol is to determine the impact of bariatric surgery on taste     receptors and taste perceptions and to precise the factors implicated in taste alterations in     50 obese patients before and 6 months after bariatric surgery (25 Roux Y gastric bypass and     25 sleeve gastrectomy).   "
60226|NCT02497261|"     The purpose of this study is to determine if avoidance of peanut by children with positive     allergy testing to peanut in the first 5 years of life increases the likelihood of developing     a persistent peanut allergy by age 5 years. To answer this question, the investigators need     to determine which children with positive allergy testing to peanut have reactions after     eating peanut (allergic to peanut) and which are able to tolerate eating peanut (not     allergic).      The investigators plan to conduct double-blind placebo-controlled peanut challenges (gold     standard for peanut allergy diagnosis) for CHILD study (http://www.canadianchildstudy.ca)     participants who had positive skin prick testing to peanut at ages 1, 3 or 5 years (in other     words, children who are sensitized to peanut, but may or may not be allergic to peanut) and     who are avoiding peanut without ever having had a reaction or whose history suggests that     they may have outgrown a known peanut allergy. These challenges will not change a child's     ability to tolerate peanut, but will determine if children who are avoiding peanut are     allergic to peanut (and need to continue avoiding peanut) or clinically tolerant to peanut     (and may continue to eat peanut after passing the challenge).   "
60227|NCT02497248|"     Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a     limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the     therapy of choice in drug-refractory patients. Recent studies have shown that ablation have a     greater efficacy in patients in whom AF is maintained hierarchically and after ablation of     rotors. The non-invasive identification of specific mechanism of AF maintenance in each     patient could allow the selection of the most appropriate treatment.   "
60228|NCT02497235|"     The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H)     enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron     emission tomography (PET) ligand [18F]MNI-792 and PET imaging and to determine the     relationship of occupancy to TAK-935 exposure.   "
60229|NCT02497222|"     This study evaluates the use of RNS60 in the treatment of asthma examining regional     improvements in inflammation using PET imaging. All subjects will be treated with both RNS60     and placebo in a crossover design.   "
60230|NCT02497209|"     Aim: To collate data on Anogenital Distance (AGD) from several population studies to build an     international database for Anogenital Distance (AGD) Primary objective: To build a database     platform to promote and facilitate international collaboration on research related to AGD,     endocrine disruptors and reproductive health.      Study Design Observational study Outcome Measures Outcomes from varying projects based on the     database      Summary of eligibility criteria Population studies with subjects in whom data on AGD is     available      Procedures:      An international AGD database will be set-up with an appropriate dataset for the research     projects. This will be based on anonymised data from multiple population studies. In order to     facilitate and provide a governance structure for the study, an international AGD consortium     will be established.   "
60231|NCT02497196|"     This study investigates comparing the effects of transcranial Pulsed Current Stimulation and     transcranial Direct Current Stimulation (tDCS) (Soterix ©) and their combination on     neurophysiological outcomes on healthy subjects as well as on the clinical population for     chronic visceral pain. The study also aims to evaluate the effects of these techniques on     pain thresholds in healthy subjects as well as for chronic visceral pain patients.   "
60232|NCT02497183|"     Acute appendicitis is the most common cause of abdominal pain requiring surgical     intervention.      The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its     effectiveness, the test involves exposure to a high dose of radiation.      Using ultrasound to diagnose this condition has been described extensively in the medical     literature, and this test has a very high specificity (over 95%), however sensitivity of the     test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test     include operator dependency as well as factors such as body habitus of the patient, presence     of technical disturbances (artifacts) caused by gas in the large intestine and inadequate     cooperation from the patient during the exam. All of these factors may affect the ability to     detect sonographic signs of appendicitis.      The investigators believe that it is possible to reduce the amount of artifacts caused by the     presence of gas in the intestine by filling of the colon with liquid suspension that is     routinely given in the investigators' hospital before performing an abdominal CT and     performing an additional ultrasound scan to those patients in which the initial ultrasound     examination (without any preparation) proved to be equivocal or not diagnostic.      The target population for the study is any patient who arrives to the emergency room with     complaints of right lower quadrant abdominal pain and it is decided by the referring     physician in the ER to start diagnostic workup for suspected appendicitis by performing an     ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided     that the patient needs to continue investigation by performing a CT scan, the patient will     receive contrast material orally for approximately 180 minutes and prior to the CT the     investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat     ultrasound will allow a statistically significant improvement in the detection rate of the     appendix.   "
60233|NCT02497170|"     Translational study based on the American Association of Diabetes Educators 7 behaviors to     manage Type 2 diabetes   "
60234|NCT02497157|"     The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU),     levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate     (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who     harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) *1/*1, *1/*6 or     *1/*28.   "
60235|NCT02497144|"     Decreased exercise capacity and quality of life, increased dyspnea and fatigue perception and     hypoxemia during exercise is seen in patients with interstitial lung disease. Impaired     ventilatory response, increased lung compliance, ventilation-perfusion mismatching and     inadequate peripheral circulation causes decreased exercise capacity. Another important     factor that induce decreased exercise capacity is peripheral muscle weakness. In literature,     there is no study investigated effects of neuromuscular electrical stimulation on functional     exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical     activity level, dyspnea and fatigue perception in patients with interstitial lung disease.   "
60236|NCT02497131|"     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and     safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL     patients.      BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of     anti-cancer activity will be assessed using the revised response criteria for malignant     lymphoma (Cheson et al. 2007).      Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) and PET scan will be     performed at baseline and Cycles 3, 8, 12, and 16. Patients will have an End of Treatment     (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Patients with at     least stable disease will enter short follow up phase till month 24 with radiology assessment     every 6 months and visit every 12 weeks. After month 24 and for all patients with progressive     disease, long-term follow-up assessments (including survival, disease status and next therapy     information) will be performed every 12 weeks until either patient death or study closure,     whichever occurs first.   "
60237|NCT02497118|"     This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with     vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung     cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with     neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate     and the rate of resection, At the same time, the study before and after the anti angiogenesis     therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of     Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial     growth factor(VEGF) expression level, to understanding the correlation between the clinical     efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these     markers. In order to find the reference basis for the prediction of the effect of curative     effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer     before and after treatment with CT perfusion imaging are studied.   "
60238|NCT02497105|"     This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,     and moderate protein) in treating epilepsy. Two study groups will be comprised of children     with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet -     epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.   "
60239|NCT02497092|"     The purpose of this study is to determine whether certain intravitreal injection techniques     cause less pain than others and would therefore be beneficial for the patient's well being.   "
60240|NCT02497079|"     The purpose of this study is to compare the diagnostic efficacy of nested and realtime     polymerase chain reaction for Mycobacterium tuberculosis using EBUS-TBNA samples in patients     with isolated intrathoracic lymphadenopathy.   "
60241|NCT02497066|"     The main objective of this protocol is to determine the effectiveness of using compounded     topical pain creams for treating neuropathic, nociceptive, or mixed-pain syndromes. Since     these compounded pain creams may be associated with burning or irritation at the application     site, and possible systemic effects may present, the secondary objective is to determine the     relative satisfaction with the creams. The investigators hypothesis is that the active pain     creams may provide significant benefit compared to placebo cream.      3.1 Specific Aims        1. Specific Aim 1 will determine pain relief following treatment with the appropriate          (based on specified pain) compounded topical pain cream or a placebo cream. The          investigators hypothesis is that the compounded topical pain creams will provide greater          pain relief than placebo creams.        2. Specific Aim 2 will measure the patient satisfaction with the cream (compound or          placebo). The investigators hypothesis is that the compounded topical pain creams will          improve patient satisfaction, while the placebo cream will not result in a change in          patient satisfaction with their pain treatment.   "
60278|NCT02496585|"     The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib     in combination with steroids, has on the lungs. Furthermore, such treatments' side effects     will be studied together with quality of life. In addition, the investigators would like to     determine whether they can find markers in the blood which predict worsening lung injury.   "
60242|NCT02497053|"     The prognosis of mesothelioma is generally poor. The median survival of patients with     unresectable malignant mesothelioma ranges approximately between 6-12 months. Survival is     poor because there is no curative treatment.      Treatment options include surgery, chemotherapy and radiotherapy. Recently multimodality     treatment regimens have been reported to prolong survival. Other new therapeutic approaches     include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and     photodynamic therapy, but the results have not yet been completely validated. Even with the     introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean     survival of 12 months. The current standard of care for unresectable malignant pleural     mesothelioma is pemetrexed/cisplatin. This regimen was compared to cisplatin alone in a study     including 448 patients from 19 countries which was the largest trial to date among patients     suffering from malignant mesothelioma. Results showed statistically significant increase in     overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3 months for     cisplatin alone. In addition, there was an improvement in lung function (forced vital     capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm.      Until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in     malignant mesothelioma and there are no approved predictive markers for response.      Pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable     toxicity and so we need to rationalize its use in our Egyptian patients.      Therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of     pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for     response.   "
60243|NCT02497040|"     Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II     patients were recruited for a randomised, placebo-controlled, double-blind study and were     randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B;     n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30).     Scalp block was performed 5 min before head pinning. Systolic, diastolic and mean arterial     pressure (MAP), heart rate (HR), peripheral oxygen saturation and end-tidal carbon dioxide     were recorded. Postoperative pain was evaluated using a 10-cm visual analogue scale (VAS).   "
60244|NCT02497027|"     This is a randomized, control group design of pharmacogenetic implementation in a mental     health population of subjects taking anti-depressants and/or anti-psychotics with a new or     current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive     Disorder Not Otherwise Specified (DDNOS).   "
60245|NCT02497014|"     The objective of the study is to investigate clinical outcomes following single versus dual     stenting strategies for the treatment of true bifurcation distal left main coronary artery     lesions.   "
60246|NCT02497001|"     Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort®     Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.   "
60247|NCT02496988|"     The purpose of this study is to determine whether combining of Temozolomide and     cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with     Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of     Malignant Glioma is also evaluated.   "
60248|NCT02496975|"     This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and     traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for     other diseases, but is not approved by the Food and Drug Administration for treatment of     traumatic brain injury. The effect of Cyclosporine A on chemicals produced following brain     injury is being determined using doses no larger than those used for patients having organ     transplant. It is also being given for a much shorter time period (3 days). It is not know if     side effects seen in patients taking cyclosporine A will occur when it is given for only 3     days. It is not known if patients with brain injury that are treated with cyclosporine A will     have side effects like those seen in organ transplant patients.   "
60249|NCT02496962|"     This study aimed to investigate the effect of 48-h sleep deprivation on heart rate     variability (HRV) in young healthy people and the protective effect of statin on arrhythmia     and HRV.   "
60250|NCT02496949|"     to assess the safety, tolerability，PK and efficacy profile of two doses (600mg,800mg,BID) of     Icaritin in advanced solid tumor patients in China   "
60251|NCT02496936|"     The influences of specific dietary fat sources on satiety, appetite and energy utilization     remains unclear; evidence is lacking on whether responses vary according to acute intake. The     researchers will use a controlled setting to determine whether the source of dietary fat is     related to perceived satiety, satiety hormone responses, and energy expenditure by conducting     experiments to evaluate short term (acute) effects.   "
60252|NCT02496923|"     Background:      High risk patients with lung disease who undergo cardiac surgery are at significant risk of     postoperative complications leading to prolonged hospital stay. One method of reducing the     risk of lung complications is to treat patients with non-invasive ventilation or continuous     positive airways pressure postoperatively. However, this often requires admission to a high     dependency unit or intensive care, and is uncomfortable because of the need for a tight     fitting mask, as well as being labour intensive and costly. Nasal high flow oxygen     (Optiflow™) is a new alternative as it provides warmed humidified oxygen at high flow, and     also has been shown to assist breathing and improve recovery. It is comfortable during use     and indeed may be more comfortable than standard (dry) oxygen via a facemask (Hudson type) or     nasal prongs. It may be administered on a normal ward, however its routine use in high risk     patients with lung conditions such as asthma, chronic obstructive pulmonary disease, recent     chest infections and heavy smokers has not been tested before.      Aims/Objectives:      The primary aim of this clinical trial is to determine if prophylactic nasal high flow oxygen     (Optiflow™) therapy in cardiac surgical patients at high-risk of developing post-operative     pulmonary complications is associated with shorter hospital length of stay.      Methods:      High risk adult patients who are scheduled to undergo cardiac surgery will be recruited with     full ethical approval and informed consent. Before surgery, each patient will perform a 6-     minute walking test under the supervision of a physiotherapist. This simple tests measures     how far patients can walk in 6 minutes. Additionally, patients will undergo spirometry     testing which is used to assess how well the lungs work by measuring how much air the patient     inhales and exhales and how quickly they exhale. Patients will thereafter undergo surgery     under general anaesthesia as they would normally. After the operation they will be looked     after following our recovery protocols, incorporating pain relief, regular physiotherapy,     early mobilisation and eating and drinking, and removal of chest drains and tubes as soon as     possible.      On arrival in the critical care area after their surgery, patients will be randomly assigned     to receive supplemental oxygen via a soft facemask (Hudson Type) (standard group), or via     high-flow nasal cannulae(Optiflow™) (intervention group). Patients will be administered     oxygen for at least 24 hours after surgery.      Patients who develop breathing difficulty will receive treatment based on their clinical     need. On the fifth or sixth postoperative day they will repeat the walking test and     spirometry. The investigators will use a short questionnaire to determine if there is any     difference in how patients feel they recovered before they leave hospital and how quickly     they returned to normal activities after discharge, and also to evaluate how they tolerated     either the facemask (Hudson Type) or high flow nasal cannulae (Optiflow™).      The investigators have used data from previous studies to calculate that a total of 74     patients will be needed to take part, in order to evaluate whether high flow nasal oxygen     (Optiflow™) leads to reduced length of hospital stay after high risk cardiac surgery compared     with usual care oxygen therapy.   "
60253|NCT02496910|"     This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover     design.   "
60254|NCT02496897|"     This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B     vaccine, administered as an add-on therapy to entecavir or tenofovir.   "
60255|NCT02496884|"     DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia pain. Because it is     excreted through the kidneys, people who have reduced kidney function will not process the     drug as well as with those with normal kidney function, so the dose must be reduced. This     study will test two reduced dose levels for both moderately reduced and severely reduced     kidney function. The study will test the hypothesis that the drug will be safe and     well-tolerated in people who have both fibromyalgia and chronic kidney disease.   "
60256|NCT02496871|"     The purpose of this study is to compare two different weight management delivery methods,     social media versus a traditional care model.   "
60257|NCT02496858|"     The aim of this study is to identify genetic loci,or gene variations contributing to the     development of coronary artery disease (CAD) in Chinese young adults. Investigators will     compare coronary angiogram results to genetic findings within young CAD patients.   "
60258|NCT02496845|"     VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the treatment     of ED.   "
60291|NCT02496416|"     This study will examine the effectiveness of aquatic therapy on a range of MS-related     symptoms such as cognition, mood, fatigue and quality of life (QOL).   "
83763|NCT02189590|"     The purpose of this study is to determine if there is a difference in time for successful     fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.   "
60259|NCT02496832|"     Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is     believed that looking for low levels of oxygen (hypoxia) in tumours may give a better     understanding of how certain tumours grow or respond to certain treatments. This study will     look at hypoxia in pancreatic tumours while participants are receiving treatment with the     combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.      This study will use positron emission tomography (PET) scans to look at hypoxia in tumours.     PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a     radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to label areas of     hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans     and comparing these levels with the patient's response to treatment with gemcitabine and     TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship     between hypoxia and response to this treatment.      The main purpose of this study is to see how useful looking at hypoxia in tumours are when     they are done at different centres.   "
60260|NCT02496819|"     Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in     160 children for the age group of 6-12 years old in Australia are diagnosed with ASD.     Children with ASD have impairment in two common areas including: i) social and communication     and ii) repetitive and stereotypical patterns of behaviours. These common features result in     behavioural problems which negatively impact children's participation in school, activities     of daily living and social engagement.      Therefore, there is a need for effective interventions to overcome the behavioural problems     in children with ASD.      The purpose of the study is to investigate the effect of sensory integration (SI) and     self-regulated learning versus an activity-based control programme in reducing behavioural     problems in children with ASD that interfere with their daily livings, school, and social     engagement.      The study will adopt a randomized controlled trial design with three intervention groups: I)     self-regulated learning, II) sensory integration and III) activity-based intervention as the     control group.   "
60261|NCT02496806|"     Brown seaweeds are a rich source of phlorotannins, a characteristic class of polyphenols     which are unique to seaweeds of this type and can comprise 5 to 15 % of the dried weight.     Unlike other classes of polyphenols, there is a lack of knowledge regarding phlorotannins and     their bioavailability and bioactivity. The purpose of this study is to investigate the     absorption and metabolism of seaweed polyphenols in humans. As part of an EC project     (SWAFAX), an acute clinical intervention will be conducted to investigate the metabolism/     bioavailability of brown seaweed phlorotannins. Urine and plasma samples from 24 healthy     volunteers that consumed a seaweed capsule containing polyphenols will be collected before     and after the intervention. Data emanating from this project will provide strong scientific     evidence for bioavailability and health promoting activity of a seaweed polyphenol extract in     human volunteers.   "
60262|NCT02496793|"     The goal of this community randomized operations research study was to evaluate the effect of     a peer-facilitated community support group intervention on uptake of maternal and neonatal     child health (MNCH) and PMTCT services and on adherence outcomes in Zimbabwe.   "
60263|NCT02496780|"     Insulin replacement therapy may be effective in breaking the cycle of protein catabolism,     undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF     youth because of its potent anabolic effect. A significant number of CF patients might     benefit from this therapeutic approach with a substantial impact on morbidity and mortality.   "
60264|NCT02496767|"     This study is to assess the effect of tirasemtiv versus placebo on respiratory function in     patients with ALS.   "
60265|NCT02496754|"     Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It     can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles     growth evenly.      At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used     in around 85% patients in the investigator's center. However, patients have to inject short     term GnRH-a 0.05mg or 0.1mg daily for around 3 weeks in one IVF cycle.      Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to     increase IVF outcome by altering endometrial receptivity. Moreover, it is also very     convenient because patients do not have to inject GnRH-a daily. In order to make patients     feel more comfortable during IVF treatment, the investigators have used a new ovarian     stimulation protocol since the beginning of 2015. The investigators give patients long term     GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle     growth around 30 days later based on the hormone levels and follicle size. In the pilot     observational study of several patients, no LH surge occurred during ovarian stimulation.      The aim of this randomized controlled study is to compare the efficiency of this new protocol     and standard GnRH-a long protocol in the investigator's center.   "
60266|NCT02496741|"     This phase Ib, open-label, single-center, non-randomized clinical trial will evaluate the     toxicity and efficacy of metformin and chloroquine in isocitrate dehydrogenase 1/2-mutated     (IDH1/2MT) patients with a glioma, intrahepatic cholangiocarcinoma or chondrosarcoma.   "
60267|NCT02496728|"     The purpose of the study is to investigate the preservation or promotion of health in     students during the college years.   "
60268|NCT02496715|"     This is a pivotal trial that will examine therapeutic equivalence (BE) of a new generic     fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg     (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients     with chronic but stable asthma as defined in the National Asthma Education and Prevention     Program Expert Panel Report 3 (NAEPP 3) guidelines   "
60269|NCT02496702|"     This study evaluates the use of Playware technology for balance training. Falling among elder     is a costly problem. Research shows that training can help prevent falls. Pilot studies of     the use of Interactive Modular Tiles (IMT) show that the participants can highly increase     their physical abilities.      The interventions group will train using interactive modular tiles. The tiles include     preprogrammed games that create playful training for the participants.      The control group will receive usual care, which here refers to normal day activities.      The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and     each participant receiving 13 minutes of training each time.   "
66554|NCT02414568|"     This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin     Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in     this study.   "
60271|NCT02496676|"     Background:      - X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and     neoplasia syndrome is called XMEN syndrome. In this genetic condition, the cells have less     magnesium than normal. This makes it hard for the body to fight infections. Researchers want     to see if magnesium supplements can make it easier for the body to fight infection.      Objective:      - To see if magnesium supplements can strengthen the immune system and reduce the amount of     Epstein-Barr virus in people with XMEN syndrome.      Eligibility:      - People ages 6 and older who have XMEN syndrome      Design:        -  Participants will be screened with:        -  Medical history        -  Physical exam        -  CT scan: Participants will drink a contrast and may get dye through an IV in the arm.          They will lie in a machine that takes pictures of the body.        -  EKG: Small sticky patches on the body will trace heart rhythm.        -  Blood tests        -  The study has 2 parts.        -  Participants doing both parts will participate for 1 year and visit the clinic about 15          <TAB>times. These visits will include a physical exam and blood and urine tests.        -  Participants doing only the first part finish in 6 months and have fewer visits.        -  For study part 1, participants will take magnesium pills for 3 months and placebo pills          for another 3 months.        -  At 3 and 6 months, they will have physical exam, medical history, blood and urine tests,          <TAB>and an EKG.        -  If the magnesium pills are not helpful, participants will do study part 2.        -  They will be admitted to the hospital for 4 5 days to get magnesium for 3 days through          an arm vein.        -  They will take magnesium pills for another 6 months.   "
60272|NCT02496663|"     This phase I trial studies the side effects and best dose of necitumumab when given together     with osimertinib in treating patients with EGFR-positive non-small cell lung cancer that is     stage IV or has come back (recurrent) and who have progressed on a previous EGFR tyrosine     kinase inhibitor. Monoclonal antibodies, such as necitumumab, may block tumor growth in     different ways by targeting certain cells. Osimertinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may     be a better treatment for EGFR-mutant non-small cell lung cancer.   "
60273|NCT02496650|"     The objective of this randomized controlled study was to evaluate whether DEX addition to     benzodiazepine therapy is effective and safe for AWS patients in the intensive care unit     (ICU). Eligible participants were randomly assigned to intervention (D) and control (C)     groups. In the group D DEX infusion was started in doses 0,2-1,4 μg/kg/hr and titrated to     achieve target sedation level; symptom-triggered BZD administration (diazepam 10mg bolus)     were used wherever DEX infusion was not enough. In group K BZD boluses (diazepam 10mg) were     used to achieve target sedation level and to control AWS symptoms (symptom-triggered     administration). The primary efficacy outcomes were 24-hour diazepam consumption and     cumulative diazepam dose required over the course of ICU stay, secondary outcomes were length     of ICU stay, sedation and communication quality, haloperidol consumption.   "
60274|NCT02496637|"     The proposed study is a randomized clinical trial investigating the effects of a weight gain     and eating dysregulation prevention intervention among college freshmen women. It will     compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no     treatment control group. Appetite Awareness Training approach to increasing eating regulation     through training individuals to eat in response to their appetite cues rather than external     or emotional cues.   "
60275|NCT02496624|"     The Guided Therapeutics (GTx) program at the University Health Network is a network of     clinicians, scientists, and engineers focused on the development and translation of     image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies     developed within the GTx program include a portable intra-operative cone-beam CT (in     collaboration with Siemens) that has been evaluated in clinical trials for head and neck     surgery. The intraoperative imaging has been integrated with tracking and navigational tools     and optical imaging to provide a general surgical dashboard that is used to improve the     accuracy of surgical resection.      A recent addition to the GTx program is the development of the GTx OR, located within the     general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary     advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy     Somatom Flash provides a gold-standard in CT imaging, while the Zeego provides excellent 3D     Cone-beam CT with robotic placement for flexible integration within the operating     environment. Together, the integration of these 2 components into a single OR enables     critical evaluation of the limits of CT imaging technology for surgical guidance.      This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous placement     and localization of markers for resection of small pulmonary nodules during VATS.   "
60276|NCT02496611|"     Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to     numerous biological adaptations involving appetite, satiety, and energy expenditure in the     post- weight loss setting. Following a loss in body weight, peripheral and central mechanisms     convey a sense that energy reserves have dwindled, activating a strong counter response to     increase caloric intake. Adolescents with severe obesity are not immune to the vexing issue     of weight regain. Indeed, only 2% are able to achieve and maintain clinically-meaningful     weight loss with lifestyle modification therapy. Therefore, novel treatment paradigms focused     on long-term weight loss maintenance are urgently needed. Pharmacotherapy has the potential     to prevent weight regain by targeting specific counter-regulatory mechanisms in the post-     weight loss setting. One of the most promising candidates is the glucagon like peptide-1     receptor agonist (GLP-1RA) class, which greatly enhanced weight loss maintenance following a     short-term low calorie diet among adults with obesity. The rationale for focusing on GLP-1RA     treatment (BYDUREON™) to prevent weight regain is supported by the multiple central and     peripheral mechanisms of action targeted by this class of drug; many of which specifically     address the biological adaptations known to induce relapse. The investigators have strong     preliminary data demonstrating that GLP-1RA treatment reduces BMI in adolescents with severe     obesity. Moreover, the investigators and others have shown that although meal replacement     therapy (structured meals of known caloric content) can elicit robust short-term weight loss     among adolescents with severe obesity, weight regain is a pervasive problem. Therefore, in     this clinical trial, our innovative approach will utilize GLP-1RA treatment to target weight     regain following short-term meal replacement therapy in youth with severe obesity.     Participants who achieve ≥5% BMI reduction during the meal replacement phase will be     randomized to GLP-1RA treatment or placebo for an additional 52 weeks while simultaneously     engaging in lifestyle modification therapy. Importantly, this study will also allow us to     examine the extent to which GLP-1RA treatment addresses mechanisms of weight regain,     investigate other pleiotropic benefits of GLP-1RA, and identify predictors of weight loss     response.   "
60277|NCT02496598|"     The purpose of this study is to evaluate the effectiveness of an experimental treatment,     known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women     diagnosed with primary ovarian insufficiency (POI).   "
60438|NCT02494843|"     The purpose of this study is to characterise, in detail, the cardiac structure, function and     perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to     ascertain if haemodiafiltration provides relative myocardial protection compared to     conventional haemodialysis.   "
60279|NCT02496572|"     Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to     adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a     minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated     with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in     Uzbekistan shows that the current standard treatment greatly limits the ability to scale up     to meet the high rates of MDR TB in the region.      Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a     relapse-free cure rate of 88%. Several countries in West Africa started implementing similar     regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among     regions with high second line drug use and resistance is still limited.      The investigators propose an observational study under programmatic conditions to evaluate     the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug     resistant (XDR) TB prevalence and high second-line drug resistance setting of Karakalpakstan,     Uzbekistan.   "
60280|NCT02496559|"     Viral self-limiting infections in respiratory organs among children are common in primary     care. Serious infections have low prevalence and are challenging to distinguish from     self-limiting infections.      Prescription of antibiotics in primary care is still high but stable since 2009 in Norway,     and 90% of all antibiotics are prescribed in primary care.      C-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in     primary care, but its role in ruling-out serious infections and the cut-off value for     prescribing antibiotics has been discussed a lot.      The aim of this study is to identify if pretesting with CRP of all children 0-6 year with     fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of     antibiotics and the referral to hospital for children.   "
60281|NCT02496546|"     The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO     32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.   "
60282|NCT02496533|"     This clinical trial design evaluates whether hand massage reduces anxiety levels in cancer     patients as they undergo radiological examination to evaluate tumor response. Anxiety levels     will be investigated before massage, after massage, and following the completion of the     radiological exam. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will     be used to measure anxiety.   "
60283|NCT02496520|"     Phase I/II, open, prospective clinical trial, historically controlled. The objective is to     evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment     based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor     lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System)     CNS tumors.   "
60284|NCT02496507|"     The purpose of this study is to investigate whether a device that allows office workers to     sit or stand whilst working can reduce their sitting time at work and improve their health     over 8 weeks.   "
60285|NCT02496494|"     The purpose of this study is to evaluate the effects of conversion from cyclosporine to     tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal     transplant recipients.   "
60286|NCT02496481|"     This study involves an emergency department (ED)-based intervention utilizing Motivational     Interviewing (MI) techniques and patient-centered (e.g., tailored) print materials to promote     the correct and consistent use of size-appropriate child passenger restraints (car seats,     booster seats, and seat belts). This study is designed as a randomized pilot trial.   "
60287|NCT02496468|"     Despite its common occurrence, still little is known about pathomechanisms determining     different wheeze and asthma trajectories and phenotypes in children, and those beginning in     adulthood. Therefore, deciphering underlying determinants for different childhood and adult     asthma phenotypes is urgently needed to develop personalized treatment approaches targeting     distinct underlying mechanisms. Thereby, secondary prevention early in the disease process     can also be achieved. The decoding of such mechanisms and their translation to the individual     patient is the aim of the Disease Area Asthma Allergy of the 'German Centre for Lung     Research' (DZL).   "
60288|NCT02496455|"     The purpose of this study to determine the association between postoperative pain after     cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.   "
60289|NCT02496442|"     A. Synopsis        1. This protocol comes to direct the experiment to be performed on the Aqueduct Automatic          Continuous Irrigation system.        2. The Aquaduct System is aimed at reducing risks to the patient by decreasing the          irrigation fluid pressure he may be exposed to, reducing the procedure time and          therefore the anesthesia time, reducing the manual handling of the sterile bags and the          risk of contamination and more.        3. In general since there is no new procedure suggested and the equipment does not actually          come into contact with the human body in any direct way, there is no need to have a          clinical study for the regulation purpose. The reason for performing this experiment is          to demonstrate the new system and to find out the best way to operate it in order to          improve the process and reduce risks.        4. This information will serve the development of most suitable automation solution for          achieving the long desired continuous irrigation.        5. The experiment will be performed in the OR in MIS procedures, and will replace the          standard gravitational manual method of performing the irrigation. The surgeons and the          medical staff of the OR will be directed with the set up and operation of the system          prior to using it. The experiment will be accompanied at all times with a knowledgeable          representative of the research originator.        6. A maximum of 30 procedures will be analyzed during a period of approximately one month.          The surgeons and the medical staff will report their impression of using the system          during the procedures and will recommend the best settings achieved.      This information will be used to improve the system performance and design.   "
60290|NCT02496429|"     The primary objectives of this study is to evaluate how professionals rate the reliability     and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump     set      4.2 Secondary Objectives      The secondary objectives of this study are:        -  to evaluate the rate of usability problems with the BrownieForSymphony pump set        -  to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump          set        -  to evaluate first impression of lactating woman regarding pumping with the          BrownieForSymphony pump set   "
60292|NCT02496403|"     This is a randomized trial of two group-based models of care for buprenorphine/naloxone     (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management     (SMM) and Intensive Outpatient Treatment (IOT). The setting is a large outpatient SU     treatment program, where a medical management model of care has not been empirically tested     with bup/nx patients, and where a high prevalence of patients with co-occurring psychiatric     and medical co-morbidities are treated. SSM includes brief weekly group-based visits     consistent with previously studied medical models, and is drawn from primary care bup/nx     research. IOT is a predominant model of care in specialty treatment, and incorporates     psychosocial support, 12-step, educational and relapse-prevention based approaches. The     investigators will recruit 300 adult patients inducted onto bup/nx, randomize them to either     SMM or IOT, and conduct telephone follow-up interviews at 6 and 12 months. Study     investigators will examine the impact of these treatment approaches on 90-day bup/nx     adherence, opioid and SU abstinence, quality of life, and health care and societal costs.     Further, investigators will examine whether the effect of IOT versus SMM on adherence and SU     treatment outcomes is greater for those with medical or psychiatric co-morbidities. This     innovative approach includes a focus on complex patients with psychiatric and medical     co-morbidities in specialty care, adapting a care model previously only tested in primary     care, a 12-month follow-up, no research-forced medication taper, an examination of health     care and societal costs, and a combination of patient self-report and electronic medical     record data. Through this approach, the proposed study will yield critically important     findings on how best to treat complex prescription opioid dependent patients with an     integrative behavioral services and medication treatment model in SU treatment.   "
60293|NCT02496390|"     Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is deposited in the liver.     Almost all patients also have obesity and insulin resistance (the inability of the body to     effectively use insulin). Obesity and NAFLD are intricately intertwined and are increasing in     incidence. While weight loss is the most effective therapy for NAFLD, the investigators'     efforts are failing and in the next generation it will become the most common cause of liver     failure in Canada. Recently, researchers have focused on the potential use of altering the     composition of bacteria in the gut (microbiome) to alter absorption of energy from food,     deposition of fat and resistance to insulin. This study will determine if transplantation of     bacteria from the stool of a healthy volunteer into an individual with metabolic syndrome and     NAFLD (i.e. fecal microbiota transplant/FMT) can alter insulin resistance and reduce the     amount of fat deposited in the liver. FMT is being studied to treat several clinical     conditions and is now standard of care for the treatment of refractory Clostridium difficile     infection. Investigators are proposing a randomized controlled pilot study of FMT in 21     patients to determine the feasibility and to inform us of changes needed for a larger study.   "
60294|NCT02496377|"     Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If     the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation     the patients were randomized to the oral or intravenous (IV) group. The oral group received     160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3     epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The     IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery,     associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from     the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints     comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after     surgery, and the change in iron indices from the day of the preoperative visit to day - 1.   "
60295|NCT02496364|"     Lumbar degenerative disease surgery entails in a high blood loss, requiring often for blood     transfusion. The cost and risks involved in the use of allogeneic blood have motivated     research methods to reduce operative bleeding in these patients. One such method is the use     of anti-fibrinolytic drugs, among which is tranexamic acid.   "
60296|NCT02496351|"     A growing body of literature indicates that up to 80% of amputees may have phantom limb pain     (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from     PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The     etiology and pathophysiology of PLP are poorly understood. Some studies suggest a     somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a     analgesic technique. TENS apply a low voltage electrical current through the skin using     surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of     evidence to support any treatment for PLP, interest has turned to preventing it instead.      The aim of this study is to assess if the early use of TENS in the immediately postoperative     of major limb amputation due to peripheral vascular disease, should decrease the PLP     incidence. TENS should interfere in the mechanism of PLP production to level of the pain     fibers conduction.   "
60297|NCT02496338|"     The investigators conducted a clinical trial to evaluation the effect of a menopausal health     training for Husbands of 45-60 years women on the women's quality of life and marital     satisfaction during transitional period to menopause.   "
60298|NCT02496325|"     Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under     ultrasound-guidance.      Methods : Successive inclusions after parental consent of 60 children undergoing perineal     surgery under general anesthesia and pudendal nerve block. Data were collected from induction     of anesthesia to second post-operative day (24 hrs. after admission in recovery room). Ease     of PNB achievement was the primary objective evaluated. Efficiency in preoperative and     postoperative period was also reported.   "
60299|NCT02496312|"     The purpose of this study is to provide relevant quantitative evaluation of apathy close to     real life situation by means of a multimodal sensor system integrated.   "
60300|NCT02496299|"     It is a prospective double blind randomized study on the effect of dexamethasone added to     bupivacaine with plain bupivacaine for caudal block in patient for herniotomy.      96 patients between the ages 1-6 years will be randomly selected and divided into two groups;     B and BD.      Group B will receive 1ml/kg bupivacaine 0.25% (maximum volume 20mls) and group BD will     receive a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine 0.25% (maximum volume =     20mls).      Data taken will then be analyzed and interpreted.   "
60301|NCT02496286|"     This study will evaluate the safety and efficacy of intraperitoneal administration of     Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive     intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks     for up to six weeks, or a maximum of three treatments.   "
60302|NCT02496273|"     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of CEA     specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant     adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.   "
66649|NCT02413333|"     The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean     residual peroxide in used lens cases collected at Day 30 after neutralization at recommended     storage time.   "
60303|NCT02496260|"     Radiotherapy plays an integral role in breast cancer therapy. Multiple randomized studies     have demonstrated decreased local-regional recurrence rates and decreased breast-cancer     mortality. However, balanced with this survival benefit is the potential toxicity of the     treatment itself. In particular, cardiac effects of radiotherapy have been a concern and an     area of research for the past 20 years. From long-term follow up of patients with lymphoma,     it is known that radiotherapy can lead to increased risk of myocardial infarction, valvular     dysfunction, systolic and diastolic function abnormalities, and heart failure among     cancer-survivors. Patients with breast cancer receive lower doses to smaller volumes of the     heart, but they also have an excellent long-term survival, so it is crucial to study the     effects of low dose radiotherapy. Indeed, a recent study suggests that these effects can be     seen within the first 5 years after treatment, and that there is no dose threshold. This     study aims to develop imaging and blood biomarkers of cardiac exposure, as a first step to     identifying patients at increased risk for cardiac effects, so they can be targeted for close     monitoring and early intervention, potentially with statins or ACE inhibitors. Additionally,     by characterizing a time-course and radiation dose-volume relationship, potentially real-time     modifications can be made to RT field design for patients sensitive to RT effects. Finally,     this information can be incorporated into better designs of treatment plans for future     patients.   "
60304|NCT02496247|"     This study will test the effectiveness of a weekly village distribution of canned herring for     prevention of malnutrition in children aged 2-5 years old during a food-insecure time of the     year in rural villages in Guinea-Bissau. The study will use community health workers to     conduct the herring distribution, making this a test that will provide valuable information     on what could become a practical food aid supplementation practice. The primary study     hypothesis is that distribution of canned herring as a weekly food supplement to families     with young children at the beginning of the rainy season will prevent a seasonal decrease in     weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at     baseline.   "
60305|NCT02496234|"     Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second     most common cause of hospital acquired AKI. The development of CSA-AKI is independently     associated with an increased risk of in-hospital death. There are currently no biomarkers     that could identify patients at higher risk for AKI and current risk predictor scores that     are based on clinical and demographic information are inadequate. Therefore, a diagnostic     test for predicting AKI risk in this clinical context would assist clinicians to optimize     surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient     outcomes.      The primary purpose of this study is to measure the association between baseline expression     of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.   "
60306|NCT02496221|"     Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and     approved for the treatment of type 2 diabetes mellitus. The primary objective of this study     is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder     emptying. To make this assessment, each study participant will receive a dose of albiglutide     and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement     of the gallbladder.      The study will be comprised of two periods and 20 subjects. The screening visit will occur     within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by     a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28     days following the last dose of albiglutide or placebo. The total duration of a subject's     participation from Screening to Follow-up will be approximately 17.5 weeks.      This study is a post marketing commitment to the United States Food and Drug Administration     (USFDA).   "
60307|NCT02496208|"     This phase I trial studies the side effects and best doses of cabozantinib-s-malate and     nivolumab with or without ipilimumab in treating patients with genitourinary (genital and     urinary organ) tumors that have spread to other places in the body. Cabozantinib-s-malate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different     ways by targeting certain cells. It is not yet known whether giving cabozantinib-s-malate and     nivolumab alone or with ipilimumab works better in treating patients with genitourinary     tumors.   "
60308|NCT02496182|"     The Chronic Hypersensitivity Pneumonitis (HP), is an inflammatory disease who has an     evolution to develop progressive interstitial fibrosis, who cause the death of the patient.     Actually HP has been treated with Prednisone and occasionally with Azathioprine, but     unfortunately the treatment with these drugs have not an effective result to treat the     interstitial fibrosis.      Pirfenidone has been studied over the world for the treatment of Fibrotic diseases, with     positive results, and due to the Pirfenidone mechanism of action has anti-inflammatory and     anti-fibrotic properties, the investigators propose to evaluate the addition of Pirfenidone     to the actual treatment with Prednisone and Azathioprine in the treatment of patients with     Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.   "
60309|NCT02496169|"     The purpose of this study is to evaluate the safety and efficacy of the eucaLimus Sirolimus     Eluting stent system in patients with de novo coronary lesions.   "
60310|NCT02496156|"     This work is testing a shared medical decision making intervention for adolescents with type     1 diabetes and their parents who are candidates for adding either an insulin pump or     continuous glucose monitor to their treatment plan. The first half of the work consisted of     the stakeholder driven design, construction and refinement of web-delivered multimedia     decision aids for each of these decisions. The randomized controlled trial of that     intervention began enroling participants in February 2015. A sample of 166 eligible     adolescents who receive care at an operating entity of the Nemours Children's Health System     will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the     Shared Medical Decision Making intervention. Primary outcomes include measures of engagement     with the pertinent technology if it is chosen and measures of decision quality; Secondary     outcomes include indices of metabolic control, quality of life and parent-adolescent     relationships around diabetes management.   "
60311|NCT02496143|"     The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.   "
60312|NCT02496130|"     The goal of this study is to compare common methods of tissue extraction at the time of     minimally invasive surgery.   "
60314|NCT02496104|"     Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age     (GA)). The investigators called very preterm infants those who were born before 33 weeks of     GA. These very preterm infants have a higher risk of developing neurological complications     like developmental disabilities or cerebral palsy. To date, early assessment of these infants     is difficult and not reliable enough to detect those who are at risks of developing     neurological issues. Now, the investigators need to identify earlier these infants to provide     them interventions to improve their development (physical therapy for example). Consequently,     the investigators are examining a study whose aim is to assess preterm infants habituation.     Habituation is the newborn ability to become familiar with new environmental stimulations     (noise, light…). This habituation allows the newborn to maintain his sleep even at onset of a     noise or light. To study this phenomenon in infants born preterm near to corrected term     (around 40 weeks of postnatal GA), will allow us to better understand neurological     development of these infants. The investigators plan to compare habituation skills of preterm     infants near to their theorical date of birth (40 weeks of GA) to a population of infants     born at term. The investigators will also study the link between habituation abilities and     sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.   "
60315|NCT02496091|"     The study is designed as a retrospective and multi-center study. The study population is US     individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments.     The study includes retrospective data collection from the medical records and data collection     from one prospective study visit with a clinical examination.The primary objective is to     evaluate success. Success is defined as that the study implant and abutment are in situ and     no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant     tissues are reported during the study.   "
60316|NCT02496078|"     The purpose of this study is to determine whether a regimen consisting of daclatasvir and     asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b     infection.   "
60317|NCT02496065|"     Surgery is the primary treatment modality for many types of cancer and the extent of surgical     resection is directly related to patient survival. However, it is often difficult for     surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or     tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid     damage to critical normal tissues. The purpose of this exploratory study is to evaluate the     intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with     breast cancer.   "
60318|NCT02496052|"     To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic     lysis of intrauterine adhesions.   "
60319|NCT02496039|"     6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the     treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.   "
60320|NCT02496026|"     The objective of the study is to evaluate the effectiveness of transcranial direct current     stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal     stimulation on the impaired hemisphere will be used associated with a robotic treatment.   "
60321|NCT02496013|"     This is an open-label whole-body PET/CT study for investigation of radiation dosimetry,     plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in     healthy volunteers and patients with suspected infection. Changes of routine blood and urine     tests and any adverse events will be collected from the volunteers. Adverse events will also     be observed in the patients.   "
60322|NCT02496000|"     Randomized, double-blind, placebo-controlled, parallel group study.   "
60323|NCT02495987|"     This study aims to understand the role of metabolic tissues in the changes of the metabolism     of pregnant women and whether this contributes to some women developing metabolic diseases of     pregnancy such as gestational diabetes (GDM) or intrahepatic cholestasis of pregnancy (ICP).     Samples of adipose tissue will be taken when pregnant women are having caesarean section or     laparoscopic procedures.   "
60324|NCT02495974|"     The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with     metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as     measured by time to treatment failure defined as the time from baseline (treatment     initiation) to treatment discontinuation of enzalutamide for any reason including disease     progression, skeletal related events, treatment toxicity, patient preference, or death.   "
60325|NCT02495961|"     The prevalence of obesity and type 2 diabetes mellitus (DM) in children have been increasing     in parallel at an alarming rate. In particular, the increasing prevalence of type 2 DM is     attributable to genetic factors, clinical (waist circumference, adiposity and physical     condition) and biochemical (insulin secretion and sensitivity, lipids and inflammation) risk,     each of which represents an independent risk.      As has already studied and published in the investigators' group, the child population of     Toluca has greater expression of cardiovascular risk factors than their counterparts in     Bogota, Colombia. The metabolic characterization of the young population of Toluca and Bogota     with new biomarkers such as homocysteine and leptin is an activity that aims to provide more     metabolic data affecting young people.      Hypothesis:      After six months of follow-up there will be a greater relative risk in Mexican population to     have identified another component of metabolic syndrome compared to the young population of     Colombia.   "
60326|NCT02495948|"     The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses     compared to ULTRA lenses after 30 days of wear.   "
60550|NCT02493010|"     The primary objective of the study is to examine the safety, usability and preliminary     efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The     investigators hypothesize that after 8 weeks of hour-long interventions, participants will     show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.   "
60338|NCT02493933|"     To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as     an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in     patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly     divided to 3 groups for induction of ovulation. Group A, [PE group, n= 80] patients received     CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, [ISMN group, n=80]     received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, [NAC group, n=80] patients     received CC 100 mg/d plus NAC 1200 mg/day.   "
60327|NCT02494076|"     Asthma is a leading cause of emergency department (ED) visits for children. A novel way of     treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory     pressure works by creating pressure in the lungs to keep airways open and to clear mucus from     the lungs. PEP is already used in the treatment of asthma at the investigators institution,     but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This     study plans to learn more about the use of PEP therapy in the treatment of asthma     exacerbations in children in the emergency department. Specifically, the study aims to     evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it     reduces the need for additional therapies and admission to the hospital. This study will be a     randomized control trial comparing children who receive standard therapy to those who receive     standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to     18 years presenting to the ED with moderate to severe asthma exacerbations will be included     in the study. Reduction in clinical asthma severity will be measured by change in the     Pulmonary Asthma Score (the respiratory severity score used at the investigators     institution). The need for additional therapies and hospitalization will also be evaluated.   "
60328|NCT02494063|"     To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is     non-inferior to treatment with systematic pelvic lymphadenectomy.      The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the     reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after     systematic pelvic lymphadenectomy, but that the less radical surgery is associated with     significantly lower postoperative morbidity.   "
60329|NCT02494050|"     Anhedonia, characterized as (a) the diminished motivation to participate in activities,     and/or (b) diminished enjoyment of a pleasurable activity are common symptoms among women     diagnosed with mood disorders. This trial aims to test three treatments adapted to reduce     anhedonia.      The investigators will compare three treatment groups, specifically, two doses of Behavioral     Activation treatment for anhedonia (i.e., 12 weeks vs. 8 weeks of BA) with an active     comparator treatment, Bipolar Disorder Collaborative Care (12 weeks of BDCC). BA is a     psychotherapy approach that helps participants to identify and modify environmental sources     of their depression. BDCC is a supportive care approach that educates participants to     optimize their medication initiation or their existing medication regimen. The time frame for     this study will be between 12-14 weeks. Specifically, participants will be evaluated and     enrolled within one week, then received up to 12 weeks of treatment (tracked through this     time) and then complete two evaluations (one at week 8) and another at the end of treatment     (an expected average of 12-14 weeks after enrolling into treatment).      Primary analyses aim to compare the dose-mechanism change in BA relative to a standard     medication optimizing protocol, BDCC. The secondary analyses are to evaluate individual     differences in stated patient preferences for treatment, and group differences in treatment     effect on anhedonia, side effects, and quality of life.   "
60330|NCT02494037|"     This study describes the three-year survival outcome of consecutively recruited advanced     stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced     integrative oncology (AIO) treatment at one of the participating North American advanced     integrative oncology specialist clinics. This study also aims to describe AIO treatments     recommended by naturopathic oncologists for these advanced stage cancer patients and pilot     the collection and evaluation of health-related quality of life data on a subset of Canadian     AIO-treated patients.   "
60331|NCT02494024|"     This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the     specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with     progressive supranuclear palsy (PSP).   "
60332|NCT02494011|"     This study compared the effects of closed kinetic chain exercise and Russian current     stimulation on pain, functional disability, wrist range of motion (ROM) and grip strength in     patients with colles' fracture. Forty five patients with stable colles' fractures are     randomly classified into three groups with fifteen patients in each group; Group I received     traditional exercise in the form of; Mobilization, stretching exercises, range of motion     exercises (passive and active) and edema control of the wrist joint. Group II stimulated by     electrical Russian current in addition to traditional exercise. Group III received closed     kinetic chain exercise (wall press, plyometric wall push up, Quadruped rhythmic     stabilization, and Push up exercises) plus traditional exercise. All outcome measures     including Pain, function, Wrist ROM, and grip strength were evaluated before and after the     treatment program.   "
60333|NCT02493998|"     Mucopolysaccharidosis type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B) is a     severe neurodegenerative disorder. The purpose of this study is to learn more about the     health problems in patients with MPS IIIB and how to measure these problems over time. It     will particularly look at how the disease develops in young children. This is an     observational study, so no experimental drug will be given. The results from this study will     help us design future studies to measure whether these health problems get better when we     give experimental drug for MPS IIIB.   "
60334|NCT02493985|"     The purpose of this study is to study the effects of carbon dioxide combined with head down     tilt on cerebral physiology and anatomy. This paradigm will help establish a ground-based     analog for spaceflight, and also evaluate the ability of non-invasive devices to monitor     brain physiology.   "
60335|NCT02493972|"     This is a Multicenter prospective diagnostic study.   "
60336|NCT02493959|"     Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon     food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study     we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a     C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.   "
60337|NCT02493946|"     The purpose of the protocol is to demonstrate the safety and the efficacy of a single     injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex     (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines     between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after     repeated injections.   "
60551|NCT02492997|"     The octipolar applicator is intended for circumference reduction treatment by reduction of     adipose size and enhancement of collagen synthesis as the result thermal and non-thermal     collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF)     and pulsed electromagnetic fields (PMF) treatment on circumference reduction.   "
60340|NCT02495909|"     Objective and Hypotheses: This project has the overall objective of implementing and     evaluating new approaches to reducing the current and future burden of urinary     schistosomiasis in young children using the antihelminthic drug Praziquantel. The project     aims to (1) determine the operational health benefits of treating schistosome infections     early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome     structure (species diversity or abundance) is a risk factor for S. haematobium infection or     morbidity, and (3) elucidate the factors and underlying mechanisms mediating the     reduction/reversal of schistosome-related morbidity and resistance against     infection/re-infection in young children.   "
60341|NCT02495896|"     This pilot phase Ib trial studies the side effects and best dose of recombinant EphB4-HSA     fusion protein when given together with standard chemotherapy regimens in treating patients     with solid tumors that have spread to other places in the body and usually cannot be cured or     controlled with treatment (advanced) or have spread to other places in the body (metastatic).     Drugs used in chemotherapy, such as recombinant EphB4-HSA fusion protein, paclitaxel     albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, docetaxel, and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet     known whether standard chemotherapy regimens are more effective with recombinant ephB4-HSA     fusion protein in treating advanced or metastatic solid tumors.   "
60342|NCT02495883|"     Essential Tremor (ET) is the most common tremor disorder, currently affecting an estimated     2.9 million Americans and leading to disability and decreased quality of life in 75% of     cases. The pathophysiology of ET is poorly understood, with the source of the tremor     remaining controversial since all studies show increased activity in the cerebellum     (including mimicked tremor in controls), while animal models of ET using harmaline and a     single human PET study implicate the inferior olivary nucleus in the brainstem.      There is evidence from the investigator's laboratory that the use of resting-state functional     magnetic resonance imaging (rs-fMRI) is useful for characterizing the abnormal tremor neural     network in ET compared with controls. The goal is to identify the source of the tremor, which     is hypothesized to remain active during rest.      Current ET diagnostic criteria require the presence of postural and/or kinetic tremor, which     are assumed to be different manifestations of the same tremor oscillator. This long-standing     assumption may be incorrect based on several lines of evidence from the investigator's     laboratory, and has major implications for understanding ET pathophysiology and treatment.     The investigators will test the hypothesis that postural and kinetic tremors are generated     through different neural mechanisms.      Treatment of ET focuses on pharmacological agents of various mechanisms and rarely deep brain     stimulation of the Vim thalamus. Despite the assortment of agents used to treat ET, only ~50%     of patients benefit from a particular agent. Furthermore, the mechanisms of action on tremor     are not generally known. Understanding the mechanisms of action of various tremor-suppressing     agents is critical for future drug development. In this proposal, the investigators plan to     study the effects of ethanol (the most efficacious tremor-suppressant currently available)     and propranolol (a non-specific β-adrenergic blocker with proven efficacy and unknown     mechanism of action) on the tremor neural network.   "
60343|NCT02495870|"     Cooking meat at low temperatures for prolonged times is widely used among chefs and in food     service due to the possibility to obtain a consistent and appealing eating quality. The     method is generally termed low-temperature long-time (LTLT) cooking. In LTLT cooking, meat is     vacuum-packed and heated at temperatures between 50°C and 65°C in a water bath for several     hours. LTLT has several benefits - improved tenderness and juiciness, less cooking loss,     better vitamin retention and uncompromised food safety.      A recent PhD thesis concluded that one of the mechanisms behind the changes in eating quality     during LTLT cooking was due to the proteolytic degradation in the muscle tissue. The activity     of proteolytic enzymes has shown to be dependent on heating temperature and time where the     cathepsins were found to remain active during heat treatment. At 58°C the cathepsin B+L     activity is increased compared to 48°C and 53°C and at 55°C compared to 25°C, 40°C and 70°C.     A prolonged heating time of 17 hours at 58°C has also shown to increase cathepsin B+L     activity. The proteolytic degradation results in the occurrence of peptides and amino acids     such as tryptophan, tyrosine, leucine and histidine which could lead to a faster degree of     satiety when consumed.      According to the aminostatic hypothesis by Mellinkoff, a rise in plasma amino acids elicited     by protein ingestion could assist in the suppression of food intake and the onset of satiety.      The investigators therefore hypothesize that the ingestion of LTLT cooked pork would induce a     faster satiety response due to the higher availability of peptides and amino acids prior to     digestion. An acute meal study will elucidate this. LTLT cooking will be performed by the     cook-chill method to mimic real life where meat is rapidly chilled after heat treatment,     stored at 0-2°C and reheated and browned prior to serving.   "
60344|NCT02495857|"     The study is a prospective, multi-center, randomized, three-arm, parallel group, clinical     study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of     Investigational hyaluronate as compared to placebo injected into the target knee for the     treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the     investigational product will also be compared with Euflexxa.   "
60345|NCT02495844|"     This study is to assess the efficacy, safety, and tolerability of the investigational drug     UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in     Europe.   "
60346|NCT02495831|"     To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of     diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with     respect to 50 mg diclofenac sodium administered alone.   "
60347|NCT02495818|"     The purpose of this study is to evaluate the effect of suprascapular nerve block guided by     ultrasound combined with home exercises compared with placebo. Pain intensity, function,     pressure pain threshold and goniometry were designed to be assessed in all patients.   "
60348|NCT02495805|"     The purpose of the study is to compare continuous femoral nerve block with continuous     proximal adductor canal block for postoperative pain control and rehabilitation.   "
60349|NCT02495792|"     The purposes of this study are 1) to assess foot strike patterns initially, at six months and     at one year between two groups of runners attempting to transition to a non-rearfoot strike     pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively     compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.   "
61307|NCT02483104|"     This is a Phase 1, open-label, multicenter, dose escalation study evaluating the     tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination     with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.   "
60350|NCT02495779|"     This study is designed to investigate the acceptability, perceived need and uptake of     short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex     with men (MSM). The overall objective is to determine the feasibility of a clinic-based     Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report     occasional condomless sex and who anticipate a period of high-risk while away from home (e.g.     vacation) during the study period.   "
60767|NCT02490176|"     Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and     GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction.     The investigators planned to evaluate the effects of liraglutide on haemodynamic parameters     in patients with heart failure.   "
60351|NCT02495766|"     This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal     stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.      Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6,     the treatment will be crossed to receive the other product. The objective is to assess the     safety of a single infusion BM-MSC, and to explore its efficacy in these patients.      Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.   "
60352|NCT02495753|"     The purpose of this study is to test the hypothesis that vaginal cleansing with     povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean     infectious morbidity.   "
60353|NCT02495740|"     The effects of active commuting with an e-bike, as compared with a classic bike, on     cardiorespiratory fitness and vascular health are largely unknown. To assess whether active     commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in     untrained and overweight individuals.   "
60354|NCT02495727|"     Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength     declining up to twice as fast as muscle size. This may eventually lead to loss of     independence if tasks of daily living become too strenuous to be performed safely. Short     periods of bed rest cause very rapid loss of muscle size and strength, and studies using     healthy older participants have shown that age increases vulnerability to this muscle loss.     However, it is unlikely that healthy individuals would be faced with periods of bed rest     unless suffering a severe illness. In light of this, recent evidence has shown that even just     reducing walking to less than 1,500 steps per day for two weeks caused 4% loss of leg muscle     in over 65 year olds. This amount of activity is roughly the equivalent of being housebound,     something that may become more common into older age, for example due to prolonged bad     weather, or minor injury or illness.      This study will investigate what causes such stark muscle loss during two weeks of reduced     activity, and the impact on skeletal muscle function and size, as well as balance, body     composition, and other indicators of general health such as how the body responds to food or     exercise. Importantly, exercise strategies that could reduce muscle loss during a period of     reduced activity will also be investigated.      In brief, three groups of 10 older men (aged 65-80 years) will undertake two weeks of reduced     physical activity by limiting their daily steps to <1,500/day. All groups will then undertake     a re-training exercise programme to ensure that any losses in muscle strength or size are     regained. One of the groups will be a control, whereby they will undertake the step-reduction     intervention and re-training, but no protective exercise before or during the step-reduction     intervention. This group will allow us to achieve our primary objective of determining the     influence of two weeks of reduced physical activity on muscle strength and size in healthy     older males. The two other groups will undertake either four weeks of strength exercise     training before the step-reduction intervention, or daily home based exercise 'snacking'     during the step-reduction intervention. The potential protective benefits of the exercise     interventions in reducing the impact of two weeks of reduced activity on muscle strength and     size, and any effect on how muscle is re-gained afterwards, will be compared to the 'control'     group.   "
60355|NCT02495714|"     HOPP Learning will be implemented in elementary schools in the Horten municipality and will     assess the effect of a combined pedagogical approach, active learning, on a large student     population. Students are to increase their amount of physical activity with learning, during     a school day by one hour.   "
60356|NCT02495701|"     Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to     perform the surgical procedure. A retrospective study has described neuropraxia, ankle joint     pain and a skin burn after surgery (1). Moreover, it has been described that surgeons     performing the procedure have a learning curve related to the number of complications     described postoperatively. At the investigators' institution, hip arthroscopies have been     performed since 2010 and the 3 surgeons have 4-12 years of experience. During the past years,     changes have been made to secure the best possible comfort for the patient during the     arthroscopic procedure. Hence, there is a rationale for investigating complications after hip     arthroscopy in a setting that is less affected by the surgeon's learning curve and with the     patient comfort in focus.   "
60357|NCT02495688|"     The purpose of this study is to compare general and regional anesthesia with regard to     postoperative pain in patients who undergo surgery in a day surgery setting due to a     displaced distal radius fracture.   "
60358|NCT02495675|"     This study evaluates the work of breathing among healthy subjects under various conditions of     treatment with high flow nasal cannulas. Ten subjects will be included. The design of this     study is a cross over of five treatment periods with different flow settings.   "
60359|NCT02495662|"     This study will investigate if liposomal prednisolone is effective in promoting arteriovenous     fistula (AVF) maturation when administered to human subjects after surgical creation of a     radio-cephalic AVF.   "
60360|NCT02495649|"     The purpose of this study is to evaluate the added value of PET-CT with [18F]FDOPA tracer for     Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with     Parkinson's disease.      The investigators expect to see normal values of uptake ratio of [18F]FDOPA , in patients     with no synuclein underline pathology or previously known cardiovascular disease (no history     of high blood pressure or take medications that influence the sympathetic system- exclusion     criteria). Low values of uptake ratio is presumed to be found in patients diagnosed with     Parkinson's disease or other synuclein pathology.      The expected normal ratio of Heart/liver uptake values will be determined from scans of     patients refered to [18F]FDOPA scan and were found to have normal [18F]FDOPA scan of the     basal ganglia and no cardiovascular diseases.   "
60361|NCT02495636|"     The primary purpose of this study is to look at effects, good or bad, of combining two     investigational anti-cancer drugs called MPDL3280A and CDX-1401. CDX-1401 is given in     combination with a third agent, poly-ICLC, which is another investigational drug that is     believed to work together with CDX-1401. All investigational drugs, MPDL3280A and CDX-1401 in     conjunction with poly-ICLC, have been evaluated separately in prior studies; however, this is     the first study assessing the combination therapy.   "
60362|NCT02495623|"     A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the     Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production     in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)   "
60467|NCT02494466|"     Supraglottic airway equipment used during anaesthesia application can lead to airway     reactivity or even larynx spasm in sensitive children.      Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist     which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of     Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and     corticosteroids.   "
60493|NCT02494128|"     All parents in Sweden are offered group based parental support within Child Health Service     (CHS) but only 40% participate. Nurses feel insecure in their group leadership and express a     need for education in group leadership and group dynamics. Most CHC nurses do not have formal     education or training in group leadership and the aim of this study was to evaluate a group     based education program in group leadership for Child Health Care (CHC) nurses.   "
60363|NCT02495610|"     INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of     elevated intracranial pressure. Patients often present with the Hakim triad comprising gait     disturbance, dementia and urinary incontinence. Treatment consists of ventriculoperitoneal     (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the central nervous system     (CNS); a generally safe and welltolerated procedure nevertheless invasive in nature and     associated with surgical risk. The currently used diagnostic algorithms to predict surgery     outcome by testing patients before and after a diagnostic spinal tap temporarily reducing the     CSF volume in the CNS are of wide variability and limited validity. Developing measures to     accurately diagnose and select patients for intervention is thus of great importance. The     objective of this study is to define and validate a diagnostic algorithm for the selection of     patients with symptoms compatible with iNPH for shunt surgery.   "
60364|NCT02495597|"     The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the     results of the Lung Clearance index (LCI) . Further this study evaluates bronchial     inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years     compared with an age- and sex-matched control group. The investigators will perform a     pulmonary function test (body plethysmography with DLCO) and compare the results with the     LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood     sample to determine the level of systemic inflammation. Finally induced sputum is collected     and a cell count is performed, and cells and supernatants are analyzed for inflammatory     markers. This study will set baseline markers for future interventional studies.   "
60365|NCT02495584|"     Vitamin D insufficiency has become a global concern, with low vitamin D status associated     with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and     Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude,     increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent     survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status,     with lower levels noted in the winter months. Variations in vitamin D status have been known     to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet     (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin     D during the winter months, causing us to rely on dietary sources. The aim of this     intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental     vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this     intervention will affect subsequent dermal synthesis of vitamin D from UV exposure.     Participants will be recruited from the local community. Blood samples will be collected from     each participant at two timepoints (September/October and March/April). Pre- and     post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences     will be measured, in addition participants will undergo a dual energy x-ray absorptiometry     (DXA) scan to assess body composition and bone mineral density. Information on general     health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will     be collected. Following the dietary intervention, a subset of participants will be invited to     participate in a follow-up study, examining UV exposure during the summer months, when they     will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2     additional blood samples.   "
60366|NCT02495571|"     This study aims to assess the presence and the intensity of voluntary and cough reflex in     patients with amyotrophic lateral sclerosis (ALS), comparing the results with the healthy     control group. The assessment of the cough is fundamental to verify the mechanism of airways     protection which is particularly compromised in ALS patients.      Objective parameters of voluntary and reflex cough would be measured by the spirometer. The     reflex of cough would be elicited by a solution of citric acid through an ultrasonic     nebulizer.   "
60367|NCT02495558|"     The cough assessment is fundamental in the weaning process as it gives information on the     possibility to expel food and secretion out from the airways. The majority of persons     suffering from severe acquired brain injury are not able to cough voluntary due to severe     cognitive deficit. In the present study, it would be evaluated the intensity of the reflex     cough (RC) and the results would be correlated with weaning outcome.   "
60368|NCT02495545|"     The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and     efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the combination     of CSFD and elevation of mean arterial pressure (MAP) in patients with acute spinal cord     injury (SCI). The objectives of the trial are to evaluate (i) efficacy of reducing     intrathecal pressure (ITP) by CSFD in patients with acute SCI; (ii) preliminary efficacy of     combination of CSFD and elevation of MAP compared to elevation of MAP alone in improving     neurologic motor outcomes in patients with acute SCI; and, (iii) safety of intensive CSFD in     acute SCI patients.   "
60369|NCT02495532|"     Regional lymph node metastasis is a major determinant of local recurrence and overall     survival rates in patients with colorectal cancer. Because of the poor prognosis associated     with the presence of lymph node metastasis, stage III colorectal cancer patients should     receive adjuvant treatment with chemo and / or radiation therapy according to the site of     tumor. Several authors have investigated the use of revealing solutions for lymph node     clearance in colorectal cancer. Most studies comparing conventional histopathological     specimen examination to any lymph node clearing technique showed that the use of revealing     solutions increases the mean number of lymph nodes harvested, usually in a statistically     significant manner. It is still controversial the impact of the use of revealing solutions     for upstaging of lymph node status and consequently for the indication for adjuvant therapy.     Therefore will be conducted a randomized clinical trial to compares the performance of GEWF     and Carnoy solutions for the histopathological examination of patients with colorectal     cancer. The aim of this study is to determine the lymph node revealing solution with the best     performance (increase in the mean number of lymph node harvested and lymph node upstaging) in     patients with colorectal cancer.   "
60370|NCT02495519|"     Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm     that typically arises in the abdomen but can develop at other anatomic sites, most commonly     in the extremities. These tumors have a relatively high local failure rate after primary     treatment using surgery and/or radiotherapy, and although rarely giving rise to distant     metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may     recur adjacent to the site of surgical resection, underscoring the limitations of surgery in     the palliative setting. Therefore, effective medical therapies for AF are needed to maintain     quality of life and prolong survival.The goal of the current study was to better define the     activity of imatinib in the treatment of AF and to determine the molecular basis for     response/nonresponse   "
60552|NCT02492984|"     An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and     efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia A     in usual care settings in China for approximately 6 months or or approximately 50 exposure     days whichever occurs first   "
60371|NCT02495506|"     This study will investigate the effects of Leukocyte reduced cold-stored platelet     transfusions used in treatment of immediate postoperative blood loss in patients undergoing     thoracic surgery in combination with extracorporal circulation. Today platelet concentrates     are stored at 22 degrees C .      This is a prospective, randomized, unblinded, non-inferiority two-arm study. Aimn of study is     to compare platelet function in bleeding patients transfused with leukoreduced platelet     concentrates stored cold (4 degrees C) and in room temperature (22 degrees C). Patients with     expected time on extracorporal circulation more than 120 minutes and/or medical platelet     inhibitors will be included.      Platelet function will be assessed by use of Multiplate Aggregometry, Thromboelastography     (TEG) and/or Thromboelastometry (ROTEM). In addition post operative bleeding, and adverse     events will be recorded.   "
60372|NCT02495493|"     Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan     and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened     with higher toxicity and serious neutropenic infection. Therefore, future trials in     neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve     efficacy, but less toxicity.   "
60373|NCT02495480|"     A novel disposable sheathed gastroscope system has been shown to be safe and more efficient     in clinical practice during gastroscopy. This novel disposable sheathed endoscope system     could effectively prevent cross-infection by simply taking off the contaminated sheath after     examination of a patient and placing a new sheath on the endoscope. In this way,     investigators can save the endoscopic reprocessing time and also decrease the need for     endoscopic cleaning and disinfecting equipment.      Participants may think that placing a new sheath on the endoscope can decrease the success     rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on     the endoscope during scope insertion can probably increases distension of the colonic lumen     and loop formation. The probable adhesion may increase the discomfort of investigators and     participants. But a previous clinical study by investigators' team showed that the     participants' feeling were no significant difference (Z = -1.783, P = 0.075) between sheathed     and conventional groups. No significant differences were observed in optical clarity, or     pathology detection rate. There were no complications, and no microbial contamination was     detected. Based on this study, investigators hypothesize that compared with conventional     group, placing a new sheath on the endoscope does not significantly reduce the success rate     of cecal intubation in average patients.      The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the     endoscope versus the conventional method in average participants. The primary outcome is     cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum     pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection     rate.   "
60374|NCT02495467|"     This study is designed to evaluate the efficacy and safety of MED2005, a topically applied     glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with     erectile dysfunction (ED) immediately before sexual intercourse.   "
60375|NCT02495454|"     GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell     non-Hodgkin's lymphoma.   "
60376|NCT02495441|"     The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the     predicate device Amnisure® in detecting pre labor rupture of membranes. 4 test kits are     compared against a common referent standard (gold standard), which is clinical assessment.   "
60377|NCT02495428|"     The aim of this study was to determine the effect of Kinesio taping on lactic acid in an     running anaerobic test.   "
60378|NCT02495415|"     This study addresses the hypothesis that intermittent treatment with fenretinide intravenous     emulsion will induce objective responses in patients with relapsed or refractory Peripheral     T-cell Lymphoma (PTCL) who have failed at least one prior systemic therapy and will result in     acceptable toxicities.   "
60379|NCT02495402|"     To test the effectiveness of a single 20-30 minute motivational interviewing-based brief     intervention for substance use within HIV/AIDS settings.   "
60380|NCT02495389|"     This study is for women diagnosed with urgency incontinence or overactive bladder (OAB). Some     patients continue to have symptoms even while taking medication for OAB. The purpose of this     study is to see if women who respond to a medication called mirabegron have different bladder     bacteria than women who do not respond.   "
60381|NCT02495376|"     We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of     health related quality of life, disease symptoms, and biological correlates of stress in a     sample of young adults with cancer. The proposed work will serve as an essential foundation     for launching a program of clinical stress reduction research with this traditionally     underserved population and has the potential to lead to the discovery of specific, modifiable     psychosocial, behavioral, and biological mechanisms from which to address the problem of     health disparities with this group.   "
60382|NCT02495363|"     Examining the analgesic effect of ultrasound guided Pectoral Blocks on analgesic opioid     consumption after surgical removal of breast tissue.      This study's uniqueness is in the quantification of the analgesic effect of regional     anesthesia on its influence to reduce the use of opioid substances, and the variety of side     effects associated with them, which has yet to been described in literature.   "
60383|NCT02495350|"     In this study the investigators would like to evaluate how prelabor analgesic plan and actual     labor analgesia effects the labor satisfaction, breastfeeding success, and whether or not it     reduces postpartum depression.      Although postpartum depression has been researched and reviewed, there is little information     on how satisfaction during labor affects postpartum outcomes. The relationship between     epidural analgesia is also complex, and there has yet to be found a valid correlation between     the two parameters.      In addition although an attempt has been made to evaluate relationship between breastfeeding     and epidural analgesia, results are unclear and further research is needed.   "
60439|NCT02494830|"     This study is designed for descriptive pharmacokinetic characterization of ketamine and     norketamine in serum, urine and feces after oral single dose administration of a new     developed prolonged release tablet formulation containing 10, 20, 40 and 80 mg ketamine under     fasting conditions and for descriptive pharmacokinetic characterization of ketamine and     norketamine in serum, urine and feces after intravenous single dose administration of 5 mg     ketamine solution for infusion within 30 min   "
60384|NCT02495337|"     This proposed collection of primary tumor cells lines will benefit esophageal cancer research     within the University Health Network. This collection of gastro-esophageal tumor samples will     be used to grow primary tumor cell lines, which will provide researchers with ready samples     of various gastro-esophageal cancers. This will help to address the issue of access to these     cell lines due to the limited number of patients with gastro-esophageal tumors, and high     rates of contamination.      Samples will be collected during surgery or Esophagogastroduodenoscopy(EGD). The surgeon will     resect a sample for the research coordinator and/or fellow who will collect the sample and     take it back to the lab for processing. Samples collected will be in excess of standard     samples that are sent for pathology. The surgeon will make sure that excess samples will not     affect pathological diagnosis   "
60385|NCT02495324|"     The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to     Valsartan and Olmesartan(reference group) in patients with mild to moderate essential     hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking     required dose and 4 weeks of taking double dose.   "
60386|NCT02495311|"     The aim of this study is to assess the relationship between adenomyosis/myoma and lower     urinary tract symptoms, sexual function and gastrointestinal symptoms.   "
60387|NCT02495298|"     The trial aims to evaluate the effectiveness of Fascial Manipulation on pain reduction,     functional recovery and nerve conduction of patients with Carpal Tunnel Syndrome (CTS).     Visual Analogue Scale (VAS), Disabilities of the Arm, Shoulder and Hand scale (DASH), Boston     Carpal Tunnel Syndrome Questionnaire (BCTQ) and Electroneuromyography were assessed.      The study is blind for the patient and the raters.   "
60388|NCT02495285|"     The aim of volume replacement is to compensate a reduction in the intravascular volume e.g.     during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital     functions. So far, there is only few data on the safety and efficacy of the products under     investigation in children.      The primary aim of this non-interventional observational study (NIS) is to collect further     data of gelatine solutions in a large pediatric population during routine clinical practice.   "
60389|NCT02495272|"     The investigators are planning to determine the effect of the timing of oxytocin     administration on the amount of blood loss, necessity for additional medical or surgical     interventions.   "
60390|NCT02495259|"     The purpose of this study is to compare three different standard of care methods of     double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have     thoracic surgery in which lung isolation is required.   "
60391|NCT02495246|"     This is a clinical trial in which healthy volunteers will be administered two experimental     Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with     both vaccines one after the other in a prime/boost regimen.      All ChAd3-EBO-Z doses are 1x10^11 vp and all Ad26.ZEBOV doses are 5x10^10 vp.      Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days     later.      Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days     later.      Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days     later.      Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days     later.      The study will assess the safety of the vaccinations, and the immune responses to     vaccination. Immune responses are measured by tests on blood samples.      The ChAd3-EBO-Z and Ad26.ZEBOV vaccines are called viral vectored vaccines. They are made     from viruses which are modified so that they cannot multiply. The viruses have extra DNA in     them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so     that the immune system builds a response to Ebola without having been infected by it.      Healthy volunteers will be recruited in Oxford and London, England. The study will be     co-funded by GSK Biologicals and Crucell Holland BV.   "
60392|NCT02495233|"     The purpose of the Phase 1b part of the study is to evaluate the safety and tolerability of     ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of     ASP2215. The purpose of the Phase 2 part of the study is to evaluate the objective response     rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.   "
60393|NCT02495220|"     The purpose of the present study was to evaluate the efficacy and safety of subtenon block     (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous     dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract     surgery.   "
60394|NCT02495207|"     Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock     Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the removal     of impacted mandibular third molars on both sides of the jaw.   "
60395|NCT02495194|"     The objective of this study is to determine whether horticultural therapy would improve the     psychological well-being of the older adults. 70 healthy elderly were randomized into the     active horticultural therapy or the waitlist control group. Sessions will be conducted weekly     for 12 weeks, and monthly for 3 months. Participants would be assessed at 3 time-points: at     the start, at 3-months and at 6-months.      It was hypothesized that as compared to the waitlist control group, participants in the     active horticultural therapy will have (1) lower depression and anxiety symptomatology; (2)     higher life satisfaction; (3) feel more socially connected; and (4) improved cognitive     functioning.   "
60396|NCT02495181|"     The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept     monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard     photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD)     patients with polypoidal choroidal vasculopathy (PCV).   "
60397|NCT02495168|"     A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week     run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide     80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation     aerosol.   "
60398|NCT02495155|"     In order to determine the acceptability of a breast cancer-specific cognitive behavioral     therapy intervention, as well as to obtain preliminary data to assess efficacy in managing     symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia,     fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to     complete patient-reported outcomes assessments before and after the 8 week intervention.   "
60399|NCT02495142|"     Bariatric surgery is associated with long-term weight loss, as well as short-term     improvements in obesity-related medical comorbidities. However, a significant proportion of     patients fail to lose sufficient weight, or experience significant weight regain. Although no     robust predictors of response have been identified, pilot data that will be presented and     reviewed suggest that surgery has profound effects on eating behaviors and psychosocial     functioning, and that these factors may affect postoperative weight control.      The present investigation capitalizes on the Longitudinal Assessment of Bariatric Surgery     (LABS) consortium to conduct an in-depth examination of the psychosocial aspects of surgery     among a geographically, ethnically, and racially diverse sample of men and women undergoing     bariatric surgery. This project unites experts in the areas of psychopathology, eating     behaviors and quality of life to conduct a naturalistic study using state-of-the-art     assessment tools; to document the relationships among psychosocial factors; and to examine     psychosocial predictors of surgical outcomes.   "
60400|NCT02495129|"     This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS)     patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if     the selected [Zr-89]-rituximab PET/CT method is a valid method to assess B cells in salivary     glands of pSS patients. In Part 1 and Part 2 no IMP will be applied to the subjects. In Part     3, pSS patients (n=12) will receive the IMP, VAY736. Posted information will be focused on     Part 3.      The overarching purpose of this study is to test a new drug (VAY736) for the treatment of     pSS. In pSS, the salivary glands (the glands that produce saliva) and other organs are     affected by inflammation. A certain type of white blood cells called B cells prominently     infiltrate the salivary glands in pSS, whereas they are not present in healthy salivary     glands. Scientific evidence suggests that B cells may be involved in the disease process in     pSS and that eliminating B cells may benefit patients with pSS. This study will test a new     imaging method and a new treatment for pSS. Both the imaging method and the treatment are     specific for B cells.   "
60401|NCT02493920|"     Lung protection should start in the delivery room where, from the first breaths, the preterm     infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the     functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the     delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a     precocious functional residual capacity (FRC) both in animal and human studies. SLI     associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of     the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome     (RDS) and reduce need of mechanical ventilation (MV).      Further studies are required to evaluate the clinical utility of this maneuver. The ability     to monitor what happens to the lungs while applying different recruitment maneuvers in     preterm infants would allow the definition of a procedure that allows optimal assistance to     improve the FRC. One promising approach is provided by the forced oscillation technique     (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied     to the airway opening and the mechanical response of the respiratory system is studied by     means of the total respiratory input impedance (Zin). Zin is a complex number that can be     expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs).     Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to     changes in the mechanics of lung periphery and provides accurate information about lung     volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the     assessment of lung function in newborns submitted to SLI at birth. The investigators     hypothesized that the application in the delivery room of the SLI in the preterm infant is     effective in achieving a greater FRC and therefore a greater value of Xrs compared to a     control group not treated with the SLI.   "
60402|NCT02493907|"     Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with     severe systolic heart failure (HF) and ventricular desynchronization. Despite the     consistently observed structural and functional improvements as well as reductions in HF     events and mortality in large multicenter randomized trials, 30% patients remain classified     as nonresponders. Present evidences showed that QRS duration was the most effective parameter     to predict responsivity of CRT in patients with severe HF. But some studies showed that QRS     duration could be influenced by obesity and gender. Accordingly, the simple QRS interval     width of body surface electrocardiograph should not be the most satisfactory parameter for     screening patients suitable for CRT. Recent study showed that left ventricular electrical     delay, as measured by the time from the onset of QRS to the LV electrogram peak (QLV),     predicted CRT response. At long QLV intervals, atrioventricular optimization (AVO) can     increase the likelihood of structural response to CRT. However, it is unclear whether it is     suitable for Chinese patients. The investigators would like to validate this relation in a     Chinese population and explore if a corrected QLV might do better to predict the responsivity     of CRT.   "
60403|NCT02493894|"     Now a days, due to the change in lifestyle, the extended lifespan and the increase in the     rate of the road accidents, the need for surgical operation of spinal instrumentation has     been increased. And these surgeries are the most crucial part of neurological surgery wards.     The everyday improvements in the quality of equipment used and advancements in surgical     methods lead to best performance of these procedures and finally the higher quality of     patients' lives. The procedures of Laminectomy and pedicular screw instrumentation lead to     pain relief and better performance and developments in the quality of patients' lives.      In addition to the above mentioned improvements, you must consider the fact that these     activities are still accompanied by complications during and after surgical operation.      Nerve root injury, Thecal sac tearing, injury to the spinal cord and the inappropriate     sagittal balance are the most significant side effects during spinal surgery.      One of the most important complications during and after these surgeries is perioperative     bleeding that causes problems both for the patients and the surgeon.   "
60404|NCT02493881|"     The investigators hypothesized that, sometimes the posterior branch of the recurrent     laryngeal nerve may also have motor function. The investigators aimed to evaluate motor     function of the branches in the branching recurrent laryngeal nerves in this study.   "
60405|NCT02493868|"     The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral     antidepressant compared with an oral antidepressant (active comparator) plus intranasal     placebo in delaying relapse of depressive symptoms in participants with treatment-resistant     depression (TRD) who are in stable remission after an induction and optimization course of     intranasal esketamine plus an oral antidepressant.   "
60406|NCT02493855|"     To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV)     ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and     dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in     treatment-naive HCV genotype (GT) 1a-infected adults.   "
66650|NCT02413320|"     Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of     breast cancer cells in women with Stage I, II, or III triple negative breast cancer.   "
60407|NCT02493842|"     Background:      Phantom limb pain (PLP) develops in 50-80% of subjects who have a limb amputated. It is not     well known what causes PLP to develop and the current treatments have been shown to be     largely ineffective. Resent research, however, have indicated that cortical reorganizing     occurring after amputation of the cortex areas related to the missing limb may be related to     the development of PLP. Furthermore, the research indicated that by providing meaningful     sensory input coming from the phantom limb the PLP may be alleviated and the cortical     organization normalized.      Aim:      The CIP described in the current application, is part of a the EU-project EPIONE, which     aims to investigate if and how cortical normalization and PLP alleviation can be induced by     providing phantom limb sensations (sensations which seems to originate from the missing limb)     in hand amputated subjects.      Method:      In the current study, which will take place at Aalborg University Hospital (AUH), 2-4 hand     amputated subjects experiencing severe PLP will implanted with interneural nerve electrodes     in the arm stump for up to one year.      Therapy will be evaluated in two stages, first during a standardized four week phase where     the subject receives daily therapy. If the therapy is shown to be effective, therapy may be     reinitiated during a second longer therapy phase.      During the therapy sessions, selective nerve stimulation will be performed. The amputee will     experience this as sensations (movement, touch, temperature, vibration etc.) originating from     the phantom limb. While implanted, we will investigate how well we can induce these     sensations and we will provide a stimulation therapy, which consist of stimulation activities     which requires the subject to focus on the evoked sensations. Prior to, during a and     following therapy a series of assessments (standardized across all EPIONE partners to enable     comparison) will be conducted to relate therapy with PLP, cortical organization, the mental     state etc. of the subject.      Expected outcome:      The stimulation therapy is expected to alleviate PLP and induce cortical normalization. The     experience we gain might be used for deriving clinical guidelines on how to treat PLP.   "
60408|NCT02493829|"     The study will be an open label, single arm, phase I study intended to identify the safety     and tolerability of AML Cell Vaccine given to eligible MDS RAEB-2 and AML patients who have     achieved a best response of complete remission or partial remission following their first or     second course of standard induction chemotherapy.   "
60409|NCT02493816|"     Recessive dystrophic epidermolysis bullosa (RDEB) is a severe form of blistering skin disease     caused by mutations in COL7A1 gene. This study aims to assess the safety of intradermal     injections of gene-modified autologous fibroblasts in 5-10 adults with RDEB.   "
60410|NCT02493803|"     The aim of this research is to investigate the impact of dietary advice on the progression of     tooth wear over 6 months using a randomised clinical trial design. Participants with severe     tooth wear will be recruited. Half of those patients will receive a detailed dietary advice     and the other half will be receive standard of care dietary advice. Moulds will be made of     their mouths at the original appointment and 6 months later. These moulds will be scanned and     superimposed to see if there is any difference in their level of tooth wear   "
60411|NCT02493790|"     Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point     characterized by multiple systemic effects as cognitive dysfunction. This one seems to have     an impact in activity daily living, considered mainly as a cognitive-motor dual task     situations. Yet to date, no study has specifically focused in the cognitive-motor performance     in patients with COPD or on the effects during a rehabilitation program. The main objective     of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing     performance between COPD patients and healthy subjects in a single and dual task     cognitive-motor situation. The secondary objective was to assess the impact of a     rehabilitation program on these performances.   "
60412|NCT02493777|"     This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in     patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week     open-label treatment optimization period followed by a one week randomized, double-blind,     placebo-controlled test phase.   "
60414|NCT02493751|"     This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the     maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab     (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered     in combination with axitinib is estimated (dose finding portion), the dose expansion phase     will be opened to further characterize the combination in term of safety profile, anti tumor     activity, pharmacokinetics, pharmacodynamics and biomarker modulation.   "
60415|NCT02493738|"     Study Objectives:        -  To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and          fed condition in healthy male subjects        -  To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under          fed condition in healthy male subjects        -  To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in          Korean healthy male subjects   "
60416|NCT02493725|"     Guillain-Barré syndrome (GBS) is an immune-mediated polyneuropathy that usually follows an     antecedent infection and causes acute neuromuscular paralysis. GBS is currently classified     into the two major subtypes: a classical demyelinating type and axonal variant type. Whereas     in Europe and North America demyelinating GBS is the major subtype, in East Asia and Central     and South America, axonal GBS is found in 30~65% of patients. Although the pathophysiology of     GBS has not been fully understood, major advances have been made in understanding the     pathophysiology particularly for the axonal form of GBS. It is now established that axonal     GBS is caused by molecular mimicry of human gangliosides by the Campylobacter jejuni     lipo-oligosaccharides. Autoantibodies bind to GM1 or GD1a at the nodes of Ranvier, activate     complements, and disrupt sodium channel clusters and axo-glial junctions, resulting in the     nerve conduction failure and muscle weakness. C. jejuni infection induces production of     antibodies, which cross-react with gangliosides on the human nerve axolemma, and activate the     complements, resulting in formation of membrane attack complex (MAC). The pathology leads to     axonal degeneration.      The standard treatments for GBS are plasma exchange and intravenous immunoglobulin and the     disease progression reaches its nadir within 4 weeks. However, during the acute phase, 18-28     % of the patients require artificial ventilation and 4.1-6.3 % of the patients die of     complications. Recovery takes several months or years, and 16.7-19.7 % of the patients still     require aid to walk one year after onset. Because of such serious disability of GBS patients,     an alternative novel therapy that can prevent death during acute phase or severe sequelae is     needed.      Eculizumab is a humanized monoclonal antibody of murine anti-human C5 antibody and     specifically binds to the final activation complement component C5 and inhibits MAC formation     by suppressing the cleavage reaction of C5 into C5a and C5b. The efficacy of eculizumab     against GBS has been shown in a model of axonal GBS. At present, there are no animal models     of demyelinating GBS. However, autopsy studies have shown that C3d and C5b-9 (MAC) are     deposited on the Schwan cells, and therefore eculizumab can be effective also for     demyelinating GBS.      This clinical trial will be conducted to investigate the efficacy and safety of eculizumab     for GBS to warrant future global clinical trials. Moreover, we also study the relationship     between the efficacy and clinical subtypes of GBS, such as axonal or demyelinating form. Our     trial will provide insights on whether the future global developmental plan should target the     whole spectrum of GBS world-wide or focusing on Asia and South America.   "
60417|NCT02493712|"     IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed     Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the     clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week     treatment period and 2 weeks follow up.   "
60506|NCT02493582|"     The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with     cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced     lung adenocarcinoma patients with wild-type EGFR   "
60418|NCT02495103|"     Background:      - There are no established treatments for people with certain advanced kidney cancers. These     tumors often don t respond well to currently available treatments. Researchers believe that     two drugs that treat other diseases metformin and vandetanib could help people with advanced     kidney cancer.      Objective:      - To test the combination of metformin and vandetanib in people with advanced kidney cancer.     Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose     in people with certain kidney cancers.      Eligibility:        -  For Phase I, people 18 and over with advanced kidney cancer        -  For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell          cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced          papillary renal cell carcinoma not related to a hereditary syndrome      Design:        -  The study will last many months.        -  Participants will be screened with medical history and physical exam.        -  Participants will take the study drugs by mouth every day.        -  Participants will measure and record their blood pressure every day.        -  Participants will have many tests:        -  Blood and urine tests        -  MRI, CT, PET scan, and other imaging tests: they will lie in machines that take pictures          of their body.        -  ECG: soft electrodes will be stuck to the skin. A machine will record the heart s          signals.        -  Bone scan        -  Some participants may have a gynecology evaluation or photos of skin tumors taken.        -  Participants will have an optional tumor biopsy.        -  After they stop taking the drugs, participants may have medical history, physical exam,          and blood tests. They will be contacted once a year by phone to find out how they are          doing.   "
60419|NCT02495090|"     Hypospadias is the second most common malformation of the male genitalia and consists in a     congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of     the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus     position may be located anywhere along the penile shaft, but more severe forms of hypospadias     may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior     represents approximately 70% of all the diagnosed cases.      The frequency of family reached depend on the severity of hypospadias. The number of children     which have hypospadias mutation discovered by classical technique is low. Families are often     the cause of the discovery of new genes involved in sexual differentiation because they allow     comparison of genomes of related persons, and detect more easily mutations.   "
60420|NCT02495077|"     During transplant surgery, there is a period of time when a donated kidney is removed from a     donor's body and stored until the time of the transplant surgery. The storage procedure     results in buildup of various proteins within the kidney that can injure the donated kidney     after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha).      The purpose of this study is to evaluate whether taking infliximab, which blocks TNF-alpha,     just prior to transplant surgery along with usual transplant medicines will protect the     donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy     for a longer period of time.   "
60421|NCT02495064|"     Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of     head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the     benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a     previous study.   "
60422|NCT02495051|"     The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE     is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting     the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux     disease. Because gastroesophageal reflux disease plays a major role in the development of BE     by causing repeated mucosal damage, development of BE is a concern even in children and young     adults in this specific population. The aim of this study is to assess the prevalence of BE     (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had     been treated for EA in early infancy. All eligible patients received upper gastrointestinal     endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological     suspicion of metaplasia was confirmed centrally.   "
60423|NCT02495038|"     BACKGROUND: The combinations of rocuronium and cisatracurium have a synergic effect. The     investigators studied whether the prediction is possible to have a sufficient effect of     reducing the dose when combining the two neuromuscular blocking agents through monitoring     neuromuscular relaxation during surgery.      METHODS: Each group were intubating dose group (Group I, n=27) combined Effective Dose (ED)95     rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27) reduced 10% of     each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each ED95. Before     patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse     who was not involved in this study. Each study drug was administrated to the patient and     timer was started with TOF-Watch® monitoring. Train-of-four (TOF) of the ulnar nerve was used     as setting of 2 Hz per 12 sec. The investigators checked time to TOF ratio=0 (Onset), time to     1st TOF ratio>25% (Duration 25%) and TOF 25-75% (recovery index) under total i.v. anesthesia     (TIVA). One way ANOVA was used for statistical analysis (α=0.05, β=0.2).   "
60424|NCT02495025|"     The purpose of this research study is to test the effectiveness of telephone-based early     childhood developmental screening and care coordination, compared to usual care in a primary     care pediatrics clinic. We will randomize approximately 150 participants to each study arm,     with the intervention families receiving developmental screening over the phone, and control     families receiving usual care with their pediatricians.   "
60425|NCT02495012|"     A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet     thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI)     before receiving PCI therapy, in order to provide evidence for Phase III design.   "
60426|NCT02494999|"     In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine     produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind,     parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged     3-6 months in China.   "
60427|NCT02494986|"     The purpose of this study is to provide continued access to rilpivirine (RPV) for     participants who were treated with RPV in a clinical development pediatric study with     rilpivirine and who, at the time of roll-over, experience and are expected to continue     experiencing clinical benefit from RPV treatment.   "
60428|NCT02494973|"     Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is     opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the     potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR,     after resection of CRLM have been reported.      The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to     initiate protocol-directed therapy and completed median of six cycles (range, one to six).     Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable     patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients     have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7     months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met     the prespecified end point of higher than 85% survival at 2 years and were clinically     tolerable.   "
60429|NCT02494960|"     Traditional smoking cessation clinics and telephone quitlines are expensive and 'passive' as     they require motivated smokers to visit the clinic or make a phone call to seek help.     However, in most middle-resource countries, smoking cessation clinics are not well     publicized. Most health care professionals (HCP) are not active in performing smoking     cessation counselling to their patients. They are not aware of the available smoking     cessation services or the benefits of such services and hence do not refer smokers to smoking     cessation services. On the other hand, physicians play a critical role in reducing tobacco     use by advising smoking patients to quit (Richmond, 1999). Physician's advice to quit smoking     not only motivates smokers to quit but also increases their quitting confidence (Fiore et     al., 2000; Ossip-Klein et al., 2000).      Brief smoking cessation interventions have been shown to be effective with strong evidence     from randomized controlled trials (RCTs), however, it is no evidence to show that longer     interventions are more effective than shorter interventions. If carried out in routine     clinical practice by all physicians and other HCP, brief interventions can potentially     benefit a great number of smokers and increase smoking cessation rate. Therefore, we propose     to examine the effect of a brief smoking cessation counselling intervention (10-20 seconds     AWARD model) among patients using a randomized controlled trail (RCT) design in Guangdong     province, China      This project aims to evaluate the effect of physicians' brief smoking cessation intervention     (AWARD model) in real busy clinic settings using a randomized controlled trial (RCT) design.   "
60430|NCT02494947|"     The primary purpose of this study is to investigate if systematic, high intensity,     interval-based aerobic exercise training results in regression of lipid content of     atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with     stable coronary heart disease. Composition and morphologic characteristics of plaques will be     studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound     (IVUS) in patients undergoing percutaneous coronary intervention.   "
60431|NCT02494934|"     The purpose of the study was to compare the effectiveness of cognitive behavioural therapy     (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked     vestibulodynia (PVD).   "
60432|NCT02494921|"     This is a Phase Ib/II open label clinical trial in patients with metastatic castration     resistant prostate cancer. The objective of the phase Ib portion of the study is to establish     the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV     q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral     daily doses in patients with metastatic CRPC with prior resistance to abiraterone and/or     enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three     cohorts will be enrolled to determine the MTD and DLT profile of this combination during     Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being     chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel     (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination     at the first dose level (dose level I), an alternative dosing schema may be pursued with     weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and     decreased risk of cytopenias compared with every 3 week dosing schedule.      The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of     ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the     efficacy and further define the safety of the treatment combination. Patients will be treated     with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there     is no evidence of radiographic or clinical disease progression after 9 cycles of protocol     therapy, patients may continue on single agent maintenance ribociclib until the time of     disease progression. Patients will have the option of starting maintenance ribociclib after 6     cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib     used during maintenance will be the same dose as that immediately preceding cessation of     docetaxel treatment.   "
60433|NCT02494908|"     As seen in previous studies Diffusion Tensor Imaging (DTI) MRI is able to detect very subtle     changes in brain tissue even after a very short timescale of hours resulting from performing     a cognitive task and learning, We wish to explore and compare those changes to patients with     idiopathic PD (IPD) and see if there are changes in the learning process and can we detect     them using widely available noninvasive techniques such as MRI.   "
60434|NCT02494895|"     To compare the clinical outcomes of dual antiplatelet therapy with aspirin and ticagrelor vs.     ticagrelor monotherapy at 3 months after PCI in patients with acute coronary syndrome.   "
60435|NCT02494882|"     The purpose of this study is to test the safety of a new combination of three oral drugs in     Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been     studied before in humans.      This is a phase I study in which ruxolitinib dose will start low for the first patient     together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect,     the ruxolitinib dose will slowly be made higher as new patients take part in the study. This     will help the investigators find the right dose of ruxolitinib to give together with     dexamethasone and dasatinib that will be used in future studies   "
60436|NCT02494869|"     This study is being done to look at the effect that different amounts of progressive exercise     training has on risk factors associated with developing breast cancer. These risk factors     include exercise capacity, body weight, and body composition, as well as the expression of     certain genes and levels of inflammatory factors in your breast tissue.   "
60437|NCT02494856|"     The present clinical trial randomized compared the clinical efficacy of the naproxen     associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of     postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative     bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th     postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal     of symmetrically positioned lower third molars, in two separate appointments (one to two     months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a     doubleblind, randomized and crossed manner.   "
83764|NCT02189577|"     The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate     bromide) for the treatment of COPD patients.   "
60440|NCT02494817|"     Though technology is integrated into the lives of our target population, use of any     particular technology will depend on the content delivered, aesthetic appeal, and overall     design. Based on the completion and analysis of data from Phase 1, the investigators were     able to obtain feedback on HIV-negative male couples' attitudes toward the original content     in the prevention toolkit modules. The research team, along with the web-developers, used     this feedback to specifically tailor the content of the modules to fit the unique needs of     the intervention's target population: at risk HIV-negative male couples. For Phase 2, the     investigators conducted focus groups at each site to help identify strengths and potential     areas for improvement of the prevention toolkit, which will be incorporated before piloting     it in the intervention for Phase 3 of this project. After assessing the acceptability of the     prevention toolkit, including the content of modules, aesthetic appeal, and overall design     with HIV-negative male couples target population, the research team will pilot test whether     the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence     to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex     partners, and increase testing behaviors among at-risk HIV-negative male couples. The     interactive website, herein referred to as the HIV prevention toolkit will contain unique     modules about sexual agreements and effective HIV prevention strategies.   "
60441|NCT02494804|"     The purpose of this study is to determine whether combining of Temozolomide and     cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with     Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant     Glioma is also evaluated.   "
60442|NCT02494791|"     This study will maximize identification of women with Lynch Syndrome using an enhanced     screening strategy to identify those at risk. These women will be referred to genetic     counselling for testing and those found to have Lynch Syndrome will be asked to invite first     degree relatives to participate and undergo genetic testing for Lynch Syndrome. Screening     guidelines and risk reducing surgery options for participants found to have Lynch Syndrome     will be reinforced by the study and adherence to these guidelines will be assessed annually     for ten years following Lynch Syndrome diagnosis to assess the impact and cost-effectiveness     of this enhanced screening approach.   "
60443|NCT02494778|"     The purpose of the study is to collect and assess long term data on the safety, tolerability,     and efficacy of pridopidine in patients with Huntington's disease (HD).   "
60444|NCT02494765|"     At King Khalid University hospital approximately 1200-1500 MRI are done yearly on pediatric     and neonatal patients. The investigating hospital is one of the pioneers in providing this     service in the Kingdom (which was established about 10 years ago) to the patients of this age     group. Only a small percentage of pediatric patients with age above 8 years accept the     procedure to be done without anesthesia; and majority of MRI procedures are done under     general anesthesia. The airway management of these patients is commonly accomplished with     laryngeal mask airways (LMA).      LMA are in practice of anesthesia since early 1980s. Pediatric and neonatal patients     (including ex-premature) have also been benefited by the use of LMA. There are many     advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion,     securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat,     post-operative hoarseness and coughing at the time of extubation, greater hemodynamic and     intra ocular pressure (IOP) stability.      There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA     classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other     (silicone, polyvinyl chloride or soft gel). Out of all this variety of LMAs only few are MRI     compatible (do not produce any artifact in the MRI image), for example Ambu LMA and I-gel LMA     and in King Khalid University Hospital (the investigating hospital) these two types are being     used.      On search of literature the investigators found only one study in adults in which such     comparison has been made and there was no study comparing different LMAs on the basis of     their spatial effects on anatomical structures of the neck and airway in pediatric patients     with age 12 years or below.      In this prospective randomized study, the investigators will compare the spatial relationship     of I-gel Trademark (TM) and Ambu® AuraOnce (AO)TM on pediatric airway in pediatric patients     undergoing 3-D MRI under general anesthesia (GA).   "
60445|NCT02494752|"     Contour deformity of face causes both functional as well as aesthetic problems for the     patient. Fat being an autologous tissue source is considered as an ideal soft-tissue filler     because it is abundant, readily available, inexpensive, host compatible, and can be harvested     easily and repeatedly. However absorption of grafted fat is a major problem resulting in lack     of consistency of final clinical outcome. Adipose tissue derived mesenchymal stem cells have     the potential to enhance the viability of the grafted fat and the reliability of the final     outcome of surgery. In the current study potential of mesenchymal stem cells will be studied     by comparing two groups of patients requiring fat grafting for contour deformities of face.     Control group will have fat graft with out enrichment with stem cells whereas experimental     group will have their fat graft enriched with mesenchymal stem cells. Comparison will be made     regarding viability of grafted fat in two groups.   "
60446|NCT02494739|"     The purpose of this study is to investigate the possible antioxidant and anti-inflammatory     effects of yogurt enriched with polyphenols after 2-week consumption by healthy individuals.   "
60447|NCT02494726|"     The overall purpose of this study is to evaluate how effective Thromboelastography (TEG) is     on identifying ischemic and hemorrhagic stroke patients at increased risk for bleeding after     receiving tissue plasminogen activator (tPA), as well as on differentiating between patients     in whom optimal thrombolysis has been achieved, and those whom it has not.   "
60448|NCT02494713|"     This is a study for men who have locally-advanced prostate cancer and are eligible to undergo     prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer     may spread to other organs in the future, even after the prostate is removed. If this were to     occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that     blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment     (treatment given before primary therapy) may prevent a recurrence. The purpose of this     research study is to assess the safety and benefit of ADT plus chemotherapy given before     prostate removal.   "
60449|NCT02494700|"     The goal of this clinical research study is to learn about the effectiveness of low dose     radiation therapy in patients with low grade B cell lymphoma or mantle cell lymphoma     involving the eye.   "
60450|NCT02494687|"     Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or     absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study     is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA)     expanded access program, to patients that, based on the treating doctor's assessment, could     benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux     disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.   "
60451|NCT02494674|"     This is a 1-month study that will examine the use of podcasting and a wearable wrist-worn     device to track calorie intake and promote weight loss. A podcast is a digital audio file     that can be listened to on portable media players, like iPods, and personal computers. This     study will run from July 14, 2015 to August 11, 2015. In this study, you will receive weight     loss information delivered via twice weekly podcasts. You will also track each meal you eat     by wearing a provided watch-like device.   "
60452|NCT02494661|"     The purpose of this study is to access the acceptability and potential utility of nutritional     intervention videos in 1) changing knowledge and attitudes about healthy eating, 2) improving     healthy food shopping practices, and 3) enhancing skills for stress reduction during food     shopping among low-income Latina mothers.   "
60453|NCT02494648|"     Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The     prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have     shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality     (RR = 9.1 [95%, 2.6 to 31.2]).      If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD     patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20)     appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30)     may be too demanding. Alternative treatments are rare and results are highly variable.     Therefore, it would be interesting to suggest other treatment modalities with moderate     coronary and/or minimally symptomatic OSA syndrome.   "
60454|NCT02494635|"     This research trial studies two types of tests, an ultrasound test and a biomarker test, to     see how well they predict how aggressive (invasive) bladder cancer is in samples from     patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade     the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a     microscope to see how they respond. This may allow doctors to predict how likely the cancer     cells are to spread in the body. The biomarker test uses laboratory testing of samples from     patients to study genes and other molecules that may predict the cancer invasiveness.     Comparing two different ways of predicting cancer aggressiveness may help doctors identify     how well they work, and may eventually allow doctors to predict aggressiveness without     needing to take a biopsy.   "
60455|NCT02494622|"     Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of     these cases differ from those of small schwannomas. The aim of this study was to review the     diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of     patients who underwent surgery.   "
60456|NCT02494609|"     A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin     (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy     Premenopausal Women.   "
60457|NCT02494596|"     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of     rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that     have progressed during or after standard therapy, or for which no standard therapy is     available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in     escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).   "
60459|NCT02494570|"     A phase 2 multi-center investigation of efficacy of ABI-009 (nab-rapamycin) in patients with     advanced malignant perivascular epithelioid cell tumor (PEComa)   "
60460|NCT02494557|"     Diabetic type 2 patients (DB2) has a higher prevalence of coronary artery disease (CAD) than     non-diabetic persons. Presence of CAD results in murmurs arising from the filling of the     arteries and can be detected by the CADScor System and can together with biological patient     profile indicate the risk of presence of CAD in the patient. In the pilot study 100     asymptomatic DB2-patients examined with CADScor System and biomarkers will be compared with     computed tomography (CT) cardiography and single-photon emission computed tomography (SPECT)     for assessing if combination of patient profile (gender, age etc) combined with above     measures may give rise to new improved risk scoring method for he DB2-patient.   "
60461|NCT02494544|"     Patients will be consecutively enrolled by implant. Implant groups will be those who have     undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.      The patient will conduct functional testing and answer questionnaires.      The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.   "
60462|NCT02494531|"     The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two     different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose -     and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral     metabolism dysfunction in literate versus illiterate MCI and AD patients.   "
60463|NCT02494518|"     The purpose of the study is to determine if performing different types of aerobic exercise     (cycling) before upper extremity exercises will help to improve outcomes after stroke.   "
60464|NCT02494505|"     The main objective is to study if the mycophenolate could decrease the proportion of patients     who relapse during the IVIG tapering period and after the IVIG withdrawal.   "
60465|NCT02494492|"     Uveitis is a leading cause of blindness in the children and young adult's populations. One     third of etiology are idiopathic. The reference treatments are corticosteroids and     immunosuppressive agents. They have significant side effects, and patient's compliance is     often poor. In addition, some uveitis are more resistant. Also, in these situations of     deadlock therapeutic, investigators propose a cell therapy by administering regulatory T     cells (Tregs) in the vitreous of patients.   "
60466|NCT02494479|"     This study is designed to evaluate the efficacy and safety of Prurisol using three different     oral daily dose regimens administered to subjects with active mild to moderate chronic plaque     psoriasis.   "
60479|NCT02494310|"     A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to     follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME.     The mobile diagnostic and treatment unit will be equipped with the tools and infrastructure     necessary to perform HRME, VIA, colposcopy, biopsy and treatment with cryotherapy. A team of     a colposcopist, nurse, nursing assistant, and driver will staff the mobile diagnostic and     treatment unit. The unit will travel to offer follow-up diagnostic and treatment services to     women who have screened positive during a prior visit with the mobile screening unit. The     mobile diagnostic and treatment unit will be constructed and maintained at BCH.   "
60468|NCT02494453|"     Patients with breast cancer receive low doses to smaller volumes of the heart, but they also     have an excellent long-term survival, so it is crucial to study the effects of low dose     radiotherapy. Indeed, a recent study suggests that these effects can be seen within the first     5 years after treatment, and that there is no dose threshold. The investigators wish to     develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying     patients at increased risk for cardiac effects. These patients can then be targeted for close     monitoring and early intervention, potentially with statins or ACE inhibitors. Additionally,     by characterizing a time-course and radiation dose-volume relationship, potentially real-time     modifications can be made to radiotherapy (RT) field design for patients sensitive to RT     effects. Finally, this information can be incorporated into better designs of treatment plans     for future patients.   "
60469|NCT02494440|"     The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of     the fetal femur length at third trimester of pregnancy.   "
60470|NCT02494427|"     Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The     current literature is weak and does not separate the medical results of these two techniques.     However, the efficiencies enabled by CAD/CAM could, for the price of an initial investment,     improve service to the patient by reducing the time required for these restorations, and     possibly lower care costs.      The aim of the study is to compare immediate medical results and short-term prosthetic     restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic     impacts and organizational aspects.   "
60471|NCT02494414|"     Early prognosis of cardiac arrest - nearly 40000 new cases per year in France - has been     extensively studied, highlighting a poor outcome (less than 8% at hospital discharge).     However, little is known on mid and long-term prognostic factors and how these patients do     survive from the event.      Using a regional cohort, the aim of the study is to describe long-term survival rate of     cardiac arrest survivors, and to assess the influence of treatment strategies on survival and     functional outcome.   "
60472|NCT02494401|"     This Study is a collaborative project with partners (people with scleroderma and     stakeholders) designed to refine an internet program for patients with scleroderma and to     compare the internet program to an authoritative educational book (Taking Charge of Systemic     Sclerosis [TOSS]). During a 16-week comparative effectiveness 16-week randomized controlled     trial, the investigators will recruit up to 250 patients who will be randomized to either     TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and     Families.   "
60473|NCT02494388|"     The study is based on a multi-center approach of needle based confocal laser endomicroscopy     (nCLE) combined with endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (FNA)     to evaluate pancreatic cystic lesions (PCL), in order to obtain a correct histopathological     diagnosis.After detection of PCL, certain morphological EUS features allow the discrimination     of specific cyst types. Additionally, EUS-FNA is recommended as the first-line procedure     whenever pathological diagnosis is required; however the procedure has its drawbacks, mainly     represented by the relatively low negative predictive value in diagnosing pancreatic cancer.     In this case a more precisely diagnostic tool is required; the potential role of CLE has been     explored in gastrointestinal (GI) pathology showing good accuracy for predicting the final     histopathological diagnosis based on immediate evaluation of tissue and vascular patterns.     Although the clinical impact of nCLE for the decision making algorithms in cystic pancreatic     neoplasm has not yet been described, the hypothesis is that EUS-nCLE could allow targeted     tissue sampling of cystic pancreatic neoplasms resulting in more accurate diagnosis. The aim     of the study is to describe the clinical impact of nCLE for the clinical decision management     algorithm based on EUS, EUS-FNA and/or EUS-CLE imaging criteria for cystic pancreatic     neoplasms, while evaluating also the feasibility and safety of nCLE examination.   "
60474|NCT02494375|"     The primary goal of the study is to determine whether insufficient sleep is associated with     poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether     salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and     somnolence, and whether insufficient sleep is linked to body composition. Sleep     characteristics, glycemic control, salivary amylase and body composition will be assessed 3     times, at 3-4 months intervals, in 82 type 1 diabetic children.   "
60475|NCT02494362|"     The purpose of the study is to determine whether a novel computer gaming hand exercise     regimen would improve hand and arm function and be feasible in people with hemiplegia after     Stroke affecting the hand.   "
60476|NCT02494349|"     The purpose of this study is to investigate and compare the pharmacokinetic characteristics     and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and     co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy     male volunteers.   "
60477|NCT02494336|"     This is a prospective, double-blinded, randomized controlled study comparing the efficacy of     trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for pediatric     single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in children.      Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary     dyskinesia will be screened for study inclusion. Eligible patients and their     parents/guardians will be approached and, if agreeable, consented for the study     pre-operatively. Patients will be randomized to receive either trans-incisional rectus sheath     block or intra-operative rectus sheath block under direct laparoscopic visualization. Both     will be done by the attending pediatric surgeon. The patient, patient guardians, select     research team members, and PACU staff will be blinded to the method of analgesic     administration.   "
60478|NCT02494323|"     Seventy (70) subjects put on the Ness L300 System, a FES device for ankle dorsiflexion for     patients with foot drop. Stimulation will be given through two different electrodes: the QFE     which is a single channel stimulation, and the Segmented Electrode which is a dual channel     electrode. The purpose of the dual channel stimulation is to enable a balanced dorsiflexion,     with no inversion/eversion inclinations. Ankle elevation will be recorded both in a seated     position and during gait. Subject preference will be recorded through BSW Questionnaire and     Subjective Survey. Twenty first subjects will be stimulated with four different dual channel     configurations. The configuration that shows to have an advantage over the others will     continue to be evaluated on fifty additional subjects. Same procedure will be taken place, in     addition ambulation tests will be performed.   "
60480|NCT02494297|"     This study is designed to compile the reasons and specific indications for the prescription     of Cyproterone Acetate combined with Ethinyl Estradiol by Health Care Providers. The primary     objective of the study is to characterize the prescribing behaviors for Cyproterone Acetate     combined with Ethinyl Estradiol in 5 European countries (Austria, Czech Republic, France, the     Netherlands, and Spain), including:        -  prescription indications for Cyproterone Acetate combined with Ethinyl Estradiol        -  use of Cyproterone Acetate combined with Ethinyl Estradiol in accordance with the          updated label        -  concomitant use of Cyproterone Acetate combined with Ethinyl Estradiol and combined          hormonal contraceptives        -  second line treatment with Cyproterone Acetate combined with Ethinyl Estradiol for the          indication acne   "
60481|NCT02494284|"     The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT)     followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies     (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications     (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after     zotarolimus-eluting stent implantation.   "
60482|NCT02494271|"     The purpose of this retrospective study was to evaluate the incidence of SSI after colorectal     surgery under the general anesthesia by different general anesthetic technique: inhalation     versus total intravenous anesthesia.   "
60483|NCT02494258|"     Rollover study supporting solid tumor and hematological disorder indications from Celgene     sponsored CC-486 protocols eligible for participation in the study.   "
60484|NCT02494245|"     The aim of the study is to compare physical activity in stroke survivors who have undertaken     a four month physical activity intervention using the STARFISH application with a control     group receiving four months of usual care.   "
60485|NCT02494232|"     Thoracic traumas are frequent causes of emergency department admissions and the third most     common cause of death from trauma. Although emergency management of major thoracic traumas     that have high mortality and morbidity were discussed and well-understood in detail in the     literature, there are limited information regarding diagnosis, emergency management,     treatment and follow-up after discharge of patients with minor blunt thoracic traumas.      The investigators aimed to investigate demographic data, physical examination findings, and     the relationship between lung injury, emergency department final diagnosis, hospitalization,     discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions     of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.   "
60486|NCT02494219|"     Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen     with culture in Pediatric patients.   "
60487|NCT02494206|"     The purpose of this study is to assess the efficacy of QBX258, a compound developed by     Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with     stage I-II breast cancer related lymphedema.   "
60488|NCT02494193|"     In deep carious lesions, presenting risk of pulp exposition, a treatment option is the     partial caries removal of carious tissue followed by provisional restoration, while this     approach is called indirect pulp capping. The aim of this double-blinding controlled     randomized clinical trial is to evaluate the success of indirect pulp capping using only     resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as     control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions,     from patients with age between 15 and 30 years treated in dental clinic at Department of     Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3     of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that     to compromise the evaluation. After detailed anamneses, the selected teeth will be     radiographed e all carious tissue from surrounding walls will be removed. At the floor of     cavity, the carious tissue will be partially removed using hand dentin excavators, remaining     the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from     the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans,     while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly,     the cavity will be provisionally restored with: Control - dress and cement of calcium     hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass     ionomer. The distance between the base of restoration and the pulp cavity cap will be     measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while the     teeth with compromised pulp vitality will be excluded from the study. The remaining patients     will be evaluated after 6 months. The distance between the base of restoration and the pulp     cavity cap will be measured again, followed by provisional restoration removal. The remaining     caries-affected dentin from floor of cavity will be fully removed and a bacteriological     evaluation performed. The consistency, colour and humidity of this tissue will be evaluated     too. Finally, the permanent restorations will performed.   "
60489|NCT02494180|"     The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in     terms of the pain levels and post-operative side effects of TUGOR   "
60490|NCT02494167|"     This research study uses special blood cells called multiple tumor-associated antigen     (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid     leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or     has not gone away after standard treatment, including an allogeneic hematopoietic stem cell     transplant (HSCT).      The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin     lymphomas that are infected with Epstein-Barr virus (EBV), the virus that causes infectious     mononucleosis (mono or the kissing disease), Epstein Barr virus (EBV). EBV is found in     cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This     suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are     able to hide from the body's immune system and escape being killed. The investigators     previously tested whether special white blood cells (called T cells) that were trained to     kill EBV-infected cells could affect these tumors, and in many patients the investigators     found that giving these trained T cells causes a complete or partial response.      In several lymphomas and other types of cancer like AML or MDS, the cancer cells do not have     EBV. The do however express other proteins that can be targeted in the same way. The     investigators have been able to infuse such tumor-targeted cells into up to 10 patients with     lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment     appears to be safe. Therefore, the investigators now want to test whether the investigators     can direct these special T cells against other types of cancers that carry similar proteins     called tumor-associated antigens (TAAs). These proteins are specific to the cancer cell, so     they either do not show up, or show up in low quantities, or normal human cells.      The investigators will grow T cells from patients' stem cell donors in the laboratory in a     way that will train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin,     which are expressed on most AML and MDS cancer cells. The cells will be infused at least 30     days post-allogeneic stem cell transplant. In this study, the investigators want see whether     these cells will be able to recognize and kill cancer cells that express these proteins.     These donor-derived multiTAA-specific T cells are an investigational product not yet approved     by the U.S. Food and Drug Administration      The purpose of this study is to find the largest safe dose of donor-derived tumor protein     multiTAA-specific T cells for patients with AML or MDS.   "
62381|NCT02469090|"     A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3     study in L-Dopa responsive PD patients with motor fluctuations (OFF episodes), designed to     determine the efficacy, safety and tolerability of APL-130277.   "
60492|NCT02494141|"     The proposed research will determine the effectiveness of curcumin for improving the health     and function of arteries in children and young adults with autosomal dominant polycystic     kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery     health by determining the physiological mechanisms (biological reasons) involved and offer     exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these     measurements in children and young adults who are randomized to receive either curcumin or     placebo for 1 year.   "
60494|NCT02494115|"     Physical embarrassment, pain and psychological impact linked to the body image distortion are     often associated to these lymphedemas. Investigators decided to study new therapeutic method     because of major discomfort due to these oedemas and doctors' difficulty to manage them.      Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This     local treatment consists in inserting in lower limbs several catheters draining into enclosed     bags in order to evacuate lymph fluid and to lower local pressure.      Very few studies have been published concerning this technique and are presenting only a     small number of cases. They cannot allow clear conclusions of this technique's efficiency but     show encouraging results.      Investigators want to collect more data on this technique using a larger number of subjects     in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer     patients presenting lower limbs lymphedema. Investigators will consider as lymphedema,     oedemas with no renal or cardiovascular identified cause and excluding anasarca.   "
60495|NCT02494102|"     The purpose of this study is to determine whether modafinil use in patients with obstructive     sleep apnea will improve postoperative delayed emergence after general anesthesia.   "
60496|NCT02494089|"     Vulnerability to psychologic distress induced by in situ simulation.      Objectives: Psychological evaluation at short and long term on working satisfaction, mental     health, and acute stress after in situ simulation. Analysis of the stress vulnerability     induced by simulation.      Design: non interventional study.      Primary outcome: Psychologic distress analysis with validated psychologic distress inventory     (Job Satisfaction Survey (JSS), General Health Quality (GHQ), Impact of Event Scale Revisited     (IESR), State-Trait Anxiety Inventory-A (STAI-A), State-Trait Anxiety Inventory -B (STAI-B)).   "
60497|NCT02493699|"     The purpose of the present study was to determine whether teaching Karate techniques training     leads to reduction in communication deficit of children with autism spectrum disorders.   "
60498|NCT02493686|"     Examination of the bone conduction of persons which according to the pure tone audiogram have     a normal age related hearing threshold in the air conduction.   "
60499|NCT02493673|"     Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder     associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate.     A causal relationship between OSA and systemic hypertension as well as peripheral endothelial     dysfunction was shown, and there is accumulating evidence from physiologic and observational     studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal     consequences of OSA. However, there are no data from randomised controlled trials proving a     causal relationship between OSA and impaired cerebral vascular reactivity (CVR). The aim of     this randomised controlled trial is to study the effects of a short-term CPAP withdrawal, and     thus returning OSA, on daytime CVR and brain oxygenation to establish whether there is a     causal relationship between OSA and cerebral vascular damage.   "
60500|NCT02493660|"     A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in     comparison to surgical repair of full thickness Massive Rotator Cuff Tear (MRCT).   "
60501|NCT02493647|"     This study tests a 12-episode Internet-based, guide enhanced Love, Sex, & Choices (LSC) HIV     prevention soap opera video series for smartphones or computers, in a randomized clinical     trial among predominately at-risk African American urban women.      The following hypotheses are to be tested: 1) The LSC treatment arm will show lower     unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high     risk partners at 6 months post intervention compared to an attention control arm 2) The LSC     treatment arm will show higher participation in HIV testing at 6 months post intervention     compared to the control.      If effective, this video intervention could be rapidly implemented and brought to scale at     low cost via the Internet, widely reaching young urban women with the goal of reducing HIV     risk behavior and increasing HIV testing.   "
60502|NCT02493634|"     This is post-market clinical follow-up study on 25 consecutive patients in two centers to     evaluate the safety and performance of magnetic resonance imaging conditional guide wire and     the acceptability of identified risks in the clinical evaluation and to detect emerging risks     on the basis of factorial evidence.The procedure will be done in patients with a clinical     indication for cardiac magnetic resonance and conventional catheterisation.   "
60503|NCT02493621|"     The goal of this retrospective chart review is to evaluate if the implementation of lumbar     plexus block placement for postoperative pain have improved conditions in the postoperative     period for patients undergoing total hip arthroplasty when compared to the placement of     epidurals for postoperative pain management.   "
60504|NCT02493608|"     The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in     pregnant patients undergoing repeat elective cesarean delivery.   "
60564|NCT02492828|"     This will be a retrospective cohort study using national register linkage data (including     prescription, inpatient, mortality, and socioeconomic data). The study period will be from     May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index     date) until their death, exiting the database, or until the end of the study period (June 30,     2015).   "
60565|NCT02492815|"     Observational study to evaluate the effectiveness and safety of ipilimumab, administered     during the European expanded access programme (EAP) in pretreated patients with advanced     (unresectable or metastatic) melanoma.   "
60505|NCT02493595|"     The study will seek to understand the effective use of a novel Microwave Radar Breast Imaging     System in a Symptomatic Breast Care Clinic. The MARIA Imaging system uses low level     non--ionising radiation (radio wave) signals to scan the breast tissue volume and to provide     a visual image of areas of varying tissue permittivity value within the volume. These areas     of varying permittivity can be shown as a two or three dimensional image and used in     conjunction with the X-Ray mammogram and ultrasound scans to provide another level of     diagnosis to the radiologist.The system works equally well in both dense and lucent breast     types and can in particular provide insight into the diagnosis in dense tissue cases. The     trial will accept symptomatic cases with suspected cancer, cysts or fibroadenoma.      The trial will use the images produced by the MARIA system and compare them to the images     obtained using X-Ray mammography. The results of the comparison will be assessed to     understand the effectiveness of the MARIA image in assisting with the identification and     location of suspected lesions for further specific analysis using Ultrasound/Biopsy.   "
60508|NCT02493556|"     Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular     damage have been studied over the last years. Studies have been conducted on animals and     humans in order to try to show the benefits of the intervention, but there is still     conflicting evidence about its protective and therapeutic effects.      Objectives: To describe the effects of LLLT on pain, strength and muscular inflammation after     plyometric exercise.      Methods: A randomized, double-blinded, placebo-controlled trial with participation of 20 male     healthy volunteers will be performed. Healthy and physically active individuals, aged between     18 and 35 years, with no history of injury on the lower limbs or contra-indications to     maximal exercise performance will be included. A protocol of 10 series with 10 repetitions of     the countermovement jump will be used to induce muscle damage at the lower limbs. Immediately     before or after the exercise protocol, LLLT will be applied on one lower limb, while the     other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm     and a cluster with 5 diodes on 8 different points of the knee extensor muscle, totalizing a     dosage of 240J. The placebo treatment will be held on the same way, but the equipment will be     turned off. The volunteers will be evaluated at baseline (before the exercise protocol) and     at follow-up of 24, 48 and 72 hours. The following outcomes will be evaluated: knee extensors     isometric peak torque by Isokinetic Dynamometer, pain by Visual Analogue Scale and muscular     tissue echo intensity by Ultrasonography.   "
60509|NCT02493543|"     The purpose of this study is to determine the autoantibody profiles after spinal cord injury     and their role in spontaneous functional recovery.   "
60510|NCT02493530|"     This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered     together with ruxolitinib in patients with myeloproliferative neoplasms (specifically:     polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.   "
60511|NCT02493517|"     The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg     with lanreotide 40mg PR in subjects with active acromegaly.   "
60512|NCT02493504|"     Arteriovenous fistula (AVF) is now the optimal method of obtaining vascular access for     dialysis. Measures such as systemic anticoagulation have been proposed as means of increasing     patency rates but enough evidence does not exist to support their use. The investigators     aimed to evaluate the efficacy of preoperative heparin injection on patency of AVF during the     first 24 hours after surgery and to determine whether such measure can be used to prevent     early thrombosis of the vascular access.   "
60513|NCT02493491|"     The Neurogenic Dysphonia/Dysphagia Registry is designed to be purely observational (i.e.     non-interventional, exploratory). Patient data collected from the registry is expected to be     consistent with any information which can be obtained during usual care of patients with     dysphonia/dysphagia treated with vocal fold augmentation.   "
60514|NCT02493478|"     Advanced airway interventions are common high risk, high stakes events for children in     intensive care units (ICU) and emergency departments (ED), with risk for life and health     threatening consequences.   "
60515|NCT02493465|"     This is a prospective, open label, single-center study, in kidney transplant recipients with     stable renal function for 12 and 120 months after transplantation, that are in use use of     calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular     hypertrophy will be investigated before and after conversion of azathioprine to everolimus.      This study will evaluate as primary objectives: the prevalence of left ventricular mass     hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability     of everolimus to reduce left ventricular mass after conversion from Azathioprine, using     sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR)     at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection     proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.   "
60516|NCT02493452|"     This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,     parallel-group clinical trial with 12 weeks of study drug therapy.   "
60517|NCT02493439|"     This study aims to test the efficacy of an intervention focused on promoting positive     emotions (Best Possible Self - BPS) to improve the psychological wellbeing of Romanian     immigrants living in Spain. It is hypothesized that the BPS intervention will significantly     improve a series of positive mental health outcomes, i.e., optimism, future expectancies, and     affect, compared to the Control group.   "
60566|NCT02492802|"     Posaconazole plasma concentration and inflammatory markers will be determined in all samples     available from routine analysis.   "
60567|NCT02492789|"     This is an open-label, multicenter, non-randomized, dose escalation phase I trial to evaluate     safety and tolerability of INCSHR01210 in patients with advanced solid tumors. The trial will     enroll subjects with advanced solid tumor who have failed current standard anti-tumor     therapies.   "
60518|NCT02493426|"     Autism spectrum disorder (ASD) is a group of severe, life-long developmental disorders.     Oxytocin (OT) is a neurohormone involved in both repetitive/rigid and social behaviors. This     study is focusing on how a single dose of intranasal OT (IN-OT) affects cognitive rigidity     and social perception tasks. Taking OT as a spray through the nose increases social and     decreases repetitive behavior in some adults with ASD, and we are exploring if it helps     children with ASD similarly. However, it is unclear whether every person with ASD has an     abnormal OT level, and if OT affects restrictive or social behavior differently.     Consequently, we aim to study whether OT treatment can be effective in treating subgroups     with specific features of ASD. We will use approaches utilizing both behavioral and     physiological responses to clarify the role of OT in ASD. We will develop a deeper     understanding of the range of social and rigid behaviors and use that information to identify     persons with ASD who would benefit from OT treatment. Potential subjects will be asked if     they want to participate in two sessions in our clinical laboratory where they will get     either single dose IN-OT or placebo. After receiving the substance, they will be asked to do     a handful of tasks while we monitor heart rate, eye movements, and collect baseline and post     intranasal blood, urine and saliva. The levels of hormones, metabolites and peptides related     to or interacting with OT will be measures in the collected samples of blood plasma, urine     and saliva. Additionally DNA will be extracted from the blood samples to study genes related     to OT and ASD.   "
63083|NCT02459938|"     The purpose of this study is to determine whether glucagon administered by microneedle patch     is comparable to glucagon administered by injection pen in the treatment of insulin-induced     hypoglycemia.   "
60519|NCT02493413|"     The purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI)     inquired by DS14 score in type D personality (distressed personality) to the relation of     autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese     patients within coronary heart disease group (CHD). As stress is the key psychological     activator of the hypothalamic-pituitary-adrenal axis (HPA axis) and therefore an important     risk factor for diminished immune competency and prevalence of chronic conditions such as     obesity, investigators chose exercise as the stress release intervention, especially as     chronic stress may have a role in obesity, related to initiation or exacerbation of the     condition. Abnormal regulation of the hypothalamic-pituitary-adrenal axis is additionally     associated with chronic inflammatory conditions. Proinflammatory T-lymphocytes are present in     visceral adipose tissue and may contribute to local inflammatory cell activation before the     appearance of macrophages, suggesting that these cells could play an important role in the     initiation and perpetuation of adipose tissue inflammation.   "
60520|NCT02493400|"     To investigate the effect of exercise or PAP prescription 3 months after completion of the     study Should elderly patients with atrial fibrillation be offered physiotherapist group     exercise or can physical activity on prescription (PAP) be used as an alternative? regarding     level of physical fitness, physical activity, heart rate and health related quality of life     (HR-QoL). Also if any of the investigated variables can predict the possible change in     physical fitness.   "
60521|NCT02493387|"     Atrial fibrillation is the most common arrhythmia, and physical activity and exercise are     sometimes avoided due to symptoms such as palpitations, fatigue and anxiety.     Physiotherapist-led group based exercise as part of cardiac rehabilitation is rare for this     group of patients, the method physical activity on prescription is used to encourage the     patient to increase their physical activity level in order to reduce the risk of premature     morbidity and mortality. However, mostly in this method you do not know the patient's ability     to perform the prescribed amount of physical activity, and its effect on physical fitness has     not been studied in patients with heart disease, neither has the effect of physiotherapist     led group-based exercise in patients with atrial fibrillation. The aim was to investigate the     impact of physiotherapy led group-based exercise compared to physical activity on     prescription in patients with atrial fibrillation regarding the level of physical fitness,     physical activity, heart rate and health related quality of life (HR-QoL).   "
60522|NCT02493374|"     This is a study of people with type 2 diabetes and high cholesterol between age 18 and 65.     This study is trying to figure out if a partial bypass of the small intestine can reverse     type 2 diabetes for people who require cholesterol lowering and who cannot tolerate the     statin drugs.   "
60523|NCT02493361|"     This is a multi-center, Phase II, open label, single-arm trial of intratumoral pIL-12 EP in     combination with pembrolizumab in patients with low TIL melanoma. Patients will initiate     treatment of pembrolizumab concurrently with the first cycle of intratumoral pIL-12 EP.     Pembrolizumab will be administered at 200 mg flat dose every 3 weeks. Cycles of intratumoral     pIL-12 EP (each cycle consisting of treatment on days 1, 5 and 8) will occur every 6 weeks as     long as patients have accessible lesions for EP. Patients will be evaluated for response     every 12 weeks by RECIST v1.1. Patients will continue on therapy if they have stable disease     or better, defined under investigator evaluation at the time of disease evaluations. Therapy     will be given until disease progression or unacceptable toxicity. The only exception will be     those patients who experience a confirmed CR and who have been on treatment for at least 6     months; these patients may discontinue treatment at the investigator's discretion. Patients     may reinitiate either therapy post-complete remission relapse if the study remains open and     the patient meets the conditions outlined in the protocol. Patients will be followed     continually for safety and tolerability by assessment of adverse events.   "
60547|NCT02493049|"     The first major objective of this pilot trial is to demonstrate that it is possible to study     myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing     lesions on MRI by using advanced imaging techniques. To demonstrate that this is possible the     investigators will recruit 24 RRMS patients who are being treated with standard disease     modifying therapy (DMT) and have new lesions identified on clinically indicated brain MRI     scans and measure myelin repair at 16 and 32 weeks using MRI measures of myelin repair. The     second major objective is to determine how much repair occurs in participants treated with     domperidone compared with those who are not treated. This will allow us to design larger     trials to confirm that domperidone improves repair. The study will also confirm the safety     and tolerability of domperidone in RRMS, determine circulating prolactin levels during dosing     with domperidone 10mg three times daily in people with RRMS, and explore the impact of other     clinical factors (such as age) on lesion repair.      In addition, blood will be collected to test for metabolomics and the investigators will bank     blood for future study of biomarkers that can help the investigators better understand MS.     Metabolomics is an experimental test where changes in the pattern of the chemicals in blood     cells are compared at different time points (during and after inflammation). There will be     random changes but changes that are common in most study participants may help identify     chemicals that signal stages in injury or repair. The investigators will also compare the     pattern of change in those with the best repair to those with the worst repair. This may help     identify a chemical that is associated with better or worse repair and help develop new     treatment strategies. There are currently no blood tests that help in the diagnosis of MS,     help determine which drug a person will respond to, or help determine a person's expected MS     outcome. Any such tests would be considered biomarkers.   "
60524|NCT02493348|"     Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically     impacts patient's quality of life. Its exact cause has not yet been identified, however     recent studies have indicated that fibromyalgia is associated with significant imbalance of     the connectivity within brain networks associated with pain, decreased functional     connectivity in the descending pain-modulating system, and increased activity in the pain     matrix related to central sensitization. It has been suggested, therefore, that treatments     that induce coherent neuronal activity, and/or stimulate synchronization of dysregulated     brain circuitry, have significant benefits, improving pain management and enhancing patient's     quality of life. Rhythmic Sensory Stimulation (RSS) is an example of a non-invasive treatment     that is thought to indirectly stimulate neuronal coherence. The present research proposal     aims to determine the effectiveness of Rhythmic Sensory Stimulation with 40 Hz sound on the     treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic     vibroacoustic stimulation at 40 Hz, 5 days per week, for 5 weeks. The treatment is     self-administered by the patients at home with the Sound Oasis Vibroacoustic Therapy System     (VTS) 1000 portable device. Measures of pain severity, fibromyalgia symptoms, sleep quality,     and depression, will be compared before and after treatment between the treatment and control     groups. The results of the present study will help to better understand the effectiveness of     Rhythmic Sensory Stimulation to the treatment of chronic pain disorders, such as     fibromyalgia, and contribute to the development of future studies to investigate the neural     driving effects of therapies based on Rhythmic Sensory Stimulation.   "
60527|NCT02493309|"     The purpose of this study is to determine whether an individuals cardio-respiratory fitness     level can protect them from the negative metabolic impacts of prolonged sitting time.      Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect of     prolonged sitting (build up of sugar, fat and insulin in the blood following a meal) will not     be as substantial, nor will light activity breaks be as advantageous, compared to individuals     with lower fitness as they have a smaller scope for metabolic improvement.   "
60528|NCT02493296|"     The present study will investigate the effect of artificially stiffening the aorta by means     of an aortic stent on central aortic haemodynamics (CAH). This study will determine whether     aortic stenting inadvertently adversely impacts on CAH, thereby providing the rational for     subsequent therapeutic intervention to reduce the associated cardiovascular risk.   "
60529|NCT02493283|"     The objectives of the study are        -  to evaluate pharmacokinetics, distribution in blood leucocytes, metabolism and          methemoglobinemia after single-dose and repeated-dose administration of 100 mg of          dapsone in healthy subjects genotyped for CYP2C9 and NAT2        -  to evaluate serum through levels, distribution in blood leucocytes and methemoglobinemia          after repeated-dose treatment with dapsone in patients with autoimmune bullous          dermatoses before and after concomitant treatment with glucocorticoids   "
60530|NCT02493270|"     The aim of this prospective study is to verify the efficacy of smoking cessation on     non-surgical periodontal therapy in adult subjects with chronic periodontitis.      Smokers that were willing to quit received periodontal treatment and concurrent smoking     cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated     examiner, blinded to smoking status, assessed periodontal status, gathered demographic and     behavioural information with a structured questionnaire and measured air carbon monoxide     concentration measurements.   "
60531|NCT02493257|"     The proposed study seeks to investigate the effect of intranasal capsaicin treatment in     patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry     (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after     treatment.   "
60532|NCT02493244|"     Tears play a vital role in vision. A thin layer of tears is always present to cover the     surface of the eye for optimal comfort and vision. There are several layers to the tear film,     and the outer most layer is comprised of lipids. This lipid layer prevents evaporation of the     tears and may be disrupted in people suffering from symptoms of dry eye. Cleaning eyelids     with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients,     and the purpose of this study is to evaluate the tear film lipid layer thickness before and     after one months treatment with Cliradex Wipes.   "
60533|NCT02493231|"     Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a     vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies     report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is     non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for     postoperative pain control, and reduce the needs of opioid.   "
60534|NCT02493218|"     Effective strategies to ameliorate the negative effects of stressful urban living are greatly     needed. D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program     of stress-reduction techniques, found to reduce mental health problems across many adult     populations.      The investigators propose to conduct a randomized controlled trial of the 12-week     school-based DSB program compared with a 12-week school-based health education control     program at Elev8 schools among 5th-8th graders to assess if DSB program is beneficial for     mental health and behavioral problems among public middle-school students.   "
60535|NCT02493205|"     The Holding Area LINQ Trial is a clinical trial designed to compare the benefits in     conducting impant procedures in the holding area of a hospital operating room vs cardiac     catheterization/electrophysiology laboratory.   "
60536|NCT02493192|"     The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical     Trial comparing the two methods of pain relief in the first time of labour was carried out.     In this study, 110 women in the first stage of labour were allocated in two study groups by a     randomised block design. One of them used the birth ball as a pain relief method,and the     other one used pethidine and haloperidol injection.   "
60537|NCT02493179|"     The purpose of this study is to examine the efficacy of dose regimen of serratiopeptidase     (serodase 5 mg) as a prospective, randomized, parallel, double blind Placebo- controlled     study.   "
60538|NCT02493166|"     Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central     nervous system, with more than 2.5 million people in the world. It is the most non-traumatic     cause of disability in young and middle-aged adults.      Because the lesions are spread in the brains, there is a variety of symptoms. The most common     symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of them after     15 years, have problems with movements in one or both upper extremities.      Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although     they are less visible, they can have a major determining influence on social or work-related     domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of     information processing, impaired memory and limited executive functions.      When a combination, of motor and cognitive task, is asked, the execution of these tasks could     be difficult with the foregoing in mind. For example problems during chatting while cooking,     typing a report at a meeting or watching television while ironing.      The dual-task paradigm assumes that the attention should be divided between two simultaneous     tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit the     separate task versus simultaneously.      Research on dual tasking with persons with MS has already studied extensively, but not     specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary research     on the DTC. They combined the movements of the upper limb with a cognitive task. The research     showed a difference between Persons with MS and the control group. At methodological level,     there is lacking on the randomization of tasks. That is an important bias because of the     learning effect of the tasks. They used only one task for the upper limb; this isn't enough     to generalize the concept of motor interference in Persons with MS.      The study has two research questions:        -  Have Persons with MS a greater DTC compared with a healthy control group? The motor task          is executed with the upper limb.        -  Is there a difference on DTC in persons with MS depending on the motor task?      This research is an observational case-control study in which individuals with MS will be     compared to a healthy control group. They will be two moments of assessments. On the first     day the general performance of the persons will be measured, by using clinical evaluation     tests and questionnaires. On the second day they will be tests on the dual tasks, specific a     comparison between single versus simultaneously performed tasks.   "
60636|NCT02491892|"     This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants     with metastatic breast cancer which has progressed during or after standard chemotherapy and     which is not amenable to curative therapy. Those who are maintaining a response to therapy or     who have stable disease at the end of the formal study period will continue treatment until     disease progression or unacceptable toxicity. Approximately 120 participants will be     enrolled.   "
60539|NCT02493153|"     The investigators are very pleased to register the study entitled A prospective study for     the effect of cholecystectomy to the liver in consideration of hepatic steatosis 3months     after cholecystectomy with Ultrasound.      This study deals with prospective ultrasound study about hepatic steatosis development 3     months after cholecystectomy. This study was approved by the Institutional Review Board of     the local institute. From Oct, 2013 to Jul, 2014, assessment of liver changes after     cholecystectomy was carried out in 82 patients with gallbladder disease. In conclusion, the     investigators thought that cholecystectomy might be considered as a risk factor for hepatic     steatosis.   "
60540|NCT02493140|"     The purpose of this study is to assess the efficacy and safety of a cashew apple extract on     weight management and associated metabolic risk factors in overweight/obese volunteers,     versus placebo, after 12 weeks of treatment.   "
60541|NCT02493127|"     Objectives:      To determine the association between priming and measurements of hand function such as grip     strength      Primary null hypothesis:      There is no difference in grip strength (best of three attempts) as a percent of the opposite     hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to     patients that complete the positively adjusted PCS.      Secondary null hypotheses:      There is no difference in grip strength (last of three attempts) as a percent of the opposite     hand between patients that complete the standard PCS compared to patients that complete the     positively adjusted PCS.      There is no difference in grip strength (best of three attempts) before and after completing     the questionnaires between patients that complete the standard PCS compared to patients that     complete the positively adjusted PCS.   "
60542|NCT02493114|"     This trial investigates the impact of curative lung cancer treatment on functional status and     exercise tolerance. Furthermore this trial investigates possible underlying causes and     consequences of deconditioning.   "
60543|NCT02493101|"     The purpose of this study is to determine the location of periostin and urine periostin level     in patients with lupus nephritis and IgA nephropathy.   "
60544|NCT02493088|"     The prediction of dangerousness remains a delicate subject, relevant in current psychiatry.     Scalable psychopathological elements identified in schizophrenia and mood disorders are     considered as most at risk for crime committing. The French High Authority of Health (HAS)     recommends to identify and prevent risk situations of violence and to develop research at     this level. Some authors have worked on criminal career and became interested in risk factors     for aberrant driving behaviors but also in environmental or clinical elements accompanying     these phases. To our knowledge, no specific study about contextual elements before misconduct     and which could lead to aberrant driving behaviors among individuals diagnosed with     antisocial personality disorder has been described to date The investigators propose to     follow individuals diagnosed with antisocial personality disorder in prison during 6 months     in order to list their conduct disorders and contextual elements upstream of these     misconducts. The investigators will also study the effect of contextual factors related to     judicial steps on the appearance of aberrant driving behaviors.   "
60545|NCT02493075|"     The objective of the study is:Phase I: To validate or otherwise determine the     Chinese-specific appropriate contact force during PVI in PAF.Phase II: To evaluate the     effectiveness and safety of ablation guided by the appropriate contact force.   "
60546|NCT02493062|"     This study is to review how the uterus heals after having open fetal surgery. Open fetal     surgery causes a scar perhaps two: one from the open fetal surgery and a second from delivery     by cesarean section; rarely, the same area of your uterus was used for both open fetal     surgery and delivery. From other studies of surgery performed on a uterus, some of the     uterine scars do not heal well. This study's intervention uses sterile saline to spread open     the inside of the uterus. The saline is slowly injected into the uterus using a catheter. An     ultrasound is performed to take pictures of the uterus, its inside and the walls of the     uterus. In this way, the healed areas from the uterine surgery can be seen with ultrasound     and evaluated. This is performed at least 6 months after delivery.      Primary Outcome:      Measure the depth of the scar and location of the scar 6 months or longer after delivery.   "
60548|NCT02493036|"     A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of     SYN-010 in Patients with Irritable Bowel Syndrome with Constipation   "
60549|NCT02493023|"     Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires     optimal sampling precision.Electromagnetic navigation systems are promising for     intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy     depends largely on correct alignment of preoperative images to the patient´s position in     space during endoscopy. In this study, the accuracy of a new fast and automatic     image-to-patient registration method during the initial phase of bronchoscopy is assessed in     patients referred for lung cancer investigation.   "
60553|NCT02492971|"     Appropriate assistive devices are important factors for the activity participation of the     disabled. These devices should be prescribed by the specialists based on their functional     needs. However, most individuals in need of assistive devices locate in the household,     school, or nursing institute, in which the professional interventions are not always     available on demand. Consequently most assistive devices are used without thorough     evaluation, therefore do not necessarily meet the exact needs of the individual. Hence an     easy-to-access and easy-to-use assistive technology device indexing system based on the     functional needs of the subjects is necessary. The goals of this two-year study are twofold:     assistive technology indexing system application(APP) development and promotion. First, the     multidisciplinary research team, composed of specialists from assistive technology,     rehabilitation, computer science, and special education fields, is going to integrate and     refine the current resources and develop an assistive technology indexing system App based on     the functional needs of the disabled. Second, in cooperation with the disabled community and     special schools, the team is going to promote the use of the App and evaluate its usability     via System Usability Scale. This App will be beneficial to the individuals in need of     assistive device application. It can also be used as an assistive device manual for the     specialists. The App will guide the individuals step by step to the proper assistive devices     based on their functional capacities. The complete system will include details of each     assistive device and link up with the related service resources. With its registering     function, the statistics collected via user clicks can serve as references for further design     adjustments and assistive device related policy modifications. All together this App can     provide comprehensive services to the disabled in need of assistive devices.   "
60554|NCT02492958|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a     single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86     years.   "
60637|NCT02491879|"     This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with     mechanical low-back pain to the emergency department.   "
63202|NCT02458391|"     The purpose of this study is to investigate which number of lymphedema therapy     treatments/week best reduces upper extremity swelling, increased arm function, and reduces     the most lymphedema symptoms.   "
60555|NCT02492945|"     This study is to assess the safety and effect of polydeoxyribonucleotide(PDRN) on the lateral     epicondylitis with ultrasonography-guided injection of the PDRN or dextrose solution.      Condition: lateral epicondylitis      Intervention Drug: polydeoxyribonucleotide, PDRN Drug: dextrose solution, 15% as     prolotherapy, active control      Phase 4      Study type: Interventional      Study design: Treatment, Parallel Assignment, Double Blind((Subject, intervention performer,     Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study      Official Title: Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient with     elbow epicondylitis in randomized double-blind active-control comparative study      Estimated Enrollment: 40   "
60556|NCT02492932|"     Two approaches are possible when the first finder needle attempt of the internal jugular vein     cannulation fails; the needle can be turned slightly laterally or the puncture point can be     moved slightly medially. This study is an ultrasonographic stimulation study to evaluate the     success rate of turning the needle laterally and moving the puncture point medially, and to     determine the proper angle or distance for the second try of internal jugular vein     cannulation.   "
60557|NCT02492919|"     There is a growing incidence of sepsis and septic shock in people after surgery, for which     there may be several reasons: more elderly people and more severe illnesses are entering     operating theatres, more invasive systems are being used to take care of patients in     intensive care units, etc... Sepsis and septic shock are the most prevalent illnesses which     cause the highest mortality in intensive care units.      The incidence of this illness is 500,000 / year in the USA, and 240-400 / 100,000 persons in     Europe. So this is a subject of great interest in hospitals and also to the National Health     System (to both health workers and the health authorities) as a lot of money is spent on this     illness.      Since the 19th century, ultraviolet rays have been known to be able to sterilize     microorganisms (to kill them); yet no ultraviolet system machine has been on the market,     until now, to control nosocomial infections.      The Medixair system, which aims to do this, has recently come on to the market. It uses     C-ultraviolet rays, which are the strongest kind of ultraviolet rays to kill microorganisms.      Thus, it is of interest to know whether this system is good enough to lower infections in     intensive care units. It is logical to believe that the the fewer the micro-organisms, the     lower the possibilities of infection.   "
60558|NCT02492906|"     Due to scarce published articles about this subject, the researchers aim to study the volume     measurements of the brain cortex of patients with primary severe knee osteoarthrosis and     those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating     the neuroimaging of cerebral volumetry with pain intensity, pain duration, knee function and     pressure pain threshold.   "
60559|NCT02492893|"     People with HIV and a substance use disorder who are reentering the community from prison or     jail face the dual risks of relapse and interruptions in adherence to antiretroviral therapy     (ART) medication. This mixed-methods randomized controlled trial will compare the stress,     substance use and ART adherence outcomes of participants in a 12-session, 90-minute weekly     yoga group intervention with participants in a treatment as usual control group. All     participants are re-entering the community, have HIV and experience substance use challenges.   "
60560|NCT02492880|"     This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study     to characterize the effects of programming features of the Boston Scientific Precision     Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.   "
60561|NCT02492867|"     This is a pilot study to improve local tumor control while maintaining the same rate of     treatment toxicity by adapting therapy to the uninvolved lung and esophagus while continuing     to adapt therapy to the tumor for patients with Stage II/III NSCLC.   "
60562|NCT02492854|"     The objective of this study is to compare the effectiveness of standard moist dressings and     PICO single-use negative pressure dressings in post-operative lower extremity bypass     patients. This study will compare the dressings' ability to decrease swelling, decrease     post-operative infection, and improve mobility and quality of life measures.      Subjects will be asked to participate in this study because they will undergo a lower     extremity bypass using the ipsilateral great saphenous vein. Subjects will then be randomized     to two post-operative treatment groups. One group will receive standard sterile gauze and the     other will receive PICO single-use negative pressure dressings. Both groups will be assessed     for study measures in follow-up visits as clinically indicated up to 1 year with the 30 day     timepoint as the primary outcome for study measures.   "
60563|NCT02492841|"     Background: Dental caries is considered an oral health problem worldwide. In Chile the last     national epidemiological study (2007) showed a national prevalence of dental caries in     children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy,     keeps the vitality of the tooth using some inductive materials mineralized tissue formation.      Objective: The main objective of this study is to evaluate the effectiveness of two     innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in     the maintenance of pulp vitality in teeth permanent molars.   "
83874|NCT02188147|"     The purpose of this study is to conduct an observational investigation of a novel care path     used to manage emergency department (ED) presenting syncope patients on an outpatient basis.   "
60569|NCT02492763|"     This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide;     Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes     mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000     mg/day).      The trial will include a 1-week screening period; an 8-week antihyperglycemic agent (AHA)     washout period, if required; a 14-week blinded therapy period (which includes single-blind     run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last     dose of investigational product.      The primary hypotheses of the trial are to assess the hemoglobin A1c (HbA1C)-lowering     efficacy of the addition of MK-8521 relative to placebo and to evaluate safety and     tolerability of MK-8521.   "
60638|NCT02491866|"     Objectives        1. to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived          quality of care in Psychiatry.        2. to analyze the implementation of this new measure in clinical practice : qualitative          analysis of the relationship patient/professional.   "
63621|NCT02452866|"     This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of     SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent     girls with bacterial vaginosis.   "
60570|NCT02492750|"     This partially randomized phase I/II trial studies the side effects and best dose of anakinra     when given together with lenalidomide and dexamethasone in treating patients with early stage     multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or     suppress the immune system in different ways and stop cancer cells from growing. Drugs used     in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with     or without anakinra in treating patients with multiple myeloma.   "
60571|NCT02492737|"     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,     pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that     harbor an IDH1 and/or IDH2 mutation   "
60572|NCT02492724|"     Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who     suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be     enrolled into the study. An 18-month recruitment period is planned with a 4-year     postoperative follow-up period for each subject. Thus, it is anticipated that the study will     require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively,     prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years     postoperatively from the date of surgery.   "
60574|NCT02492698|"     The objective was to evaluate the effect of the consumption of dual probiotic strains     containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L.     plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including     lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.   "
60575|NCT02492685|"     The investigators' study is a prospective study to evaluate the enhancement pattern of     contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential     diagnosis between gallbladder polyps by using software program of quantitative analysis.   "
60576|NCT02492672|"     The current registry is being undertaken to assess the long-term (12 month) safety and     tolerability of Venofer in the pediatric population with chronic kidney disease that requires     intravenous iron maintenance therapy.   "
60577|NCT02492659|"     Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser     assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced     phacoemulsification power and time, and comparable refractive outcome in clinic.      It is still unknown whether there are toxic substances produced due to photochemical or     high-energy physical effect of femtosecond laser during FLACS.   "
60578|NCT02492646|"     The purpose of this study is to evaluate the influence of none-lubricated dry tube on the     incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal     intubation.   "
60579|NCT02492633|"     The primary objective of this project is to evaluate the effectiveness of an enhanced     intervention vs. a standard intervention to complement a comprehensive smoke-free policy, in     a multi-site, privately managed affordable housing context.   "
60580|NCT02492620|"     It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during     the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will     result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23)     and furthermore, will result in a reduced need for ESA and intravenous iron. The     investigators further hypothesize that effective treatment of anemia and mineral metabolism     with FC in the pre-dialysis and transition period will result in improved physical     functioning, reduced hospitalization and reduced total cost of care when compared to     participants receiving contemporaneously provided standard of care therapy.   "
60581|NCT02492607|"     A substantial number of DCIS lesions will never form a health hazard, particularly if it     concerns slow-growing low-grade DCIS. This implies that many women might be unnecessarily     going through intensive treatment resulting in a decrease in quality of life and an increase     in health care costs, without any survival benefit.      The LORD (LOw Risk DCIS) study is a randomized, international, multicenter, phase III     non-inferiority trial, and aims to determine whether screen-detected low-grade DCIS can     safely be managed by an active surveillance strategy or that the conventional treatment,     being either WLE alone, WLE + RT, or mastectomy, and possibly HT, should remain the standard     of care.   "
60582|NCT02492594|"     Invasive fungal infections (IFI) in immunocompromised patients pose a major challenge for     diagnostics designed to permit timely onset of appropriate treatment. The aim of the current     clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of     IFI, is to test newly developed diagnostic approaches to invasive fungal infections in     relation to established procedures. The studies will be performed in a prospective, blinded     fashion, and represent a work package within the FUNGITECT grant supported by the European     Commission. The studies will focus on analyses of blood-samples from patients with febrile     neutropenia during treatment of acute leukemia or after hematopoietic stem cell     transplantation.   "
60583|NCT02492581|"     USE-PACT is a cohort study of patients initiating Selincro® with one-year follow-up,     performed using a random sample of prescribers. The aim of the study is to evaluate the use     of Selincro in real-life and its impact on alcohol consumption at one year.   "
60584|NCT02492568|"     To evaluate the increase in Overall Response Rate (ORR) in the pembrolizumab alone arm     compared to the pembrolizumab after SBRT arm at 12 weeks   "
60585|NCT02492555|"     The purpose of this study is to determine if the IBD patient doing home monitoring by web     app's for disease activity (DA) and fecal calprotectin (FC) on demand (OD), compared with     patients doing home monitoring scheduled interval combined with on demand(SI+OD) ( every     3.month).      Will home monitoring of DA and FC OD vs SI+OD reduce frequency of relapse in one year follow     up? Is the frequent FC measurement in SI+OD test group predictive of an early recognition of     relapse, and thus help change the naturel course of disease? Will home monitoring of DA and     FC in OD vs SI+OD change the course of the disease in terms of disease activity, spread of     the disease, hospitalizations and number of hospitalization days, required surgery and     outpatient visits? Is there a difference in patients' compliance with treatment plan between     OD vs SI+OD ? Is there difference in patients-adherence between OD vs SI+OD ?   "
60586|NCT02492542|"     The purpose of this study is to investigate the effect of electric stimulation on the pelvic     floor function in cervical cancer patients with type III hysterectomy.   "
60590|NCT02492490|"     The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF)     derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from     Donation after Citizen Death (DCD) can effectively reduce the need for post transplant     immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF     derived MSC to the recipients during and after operation to assess the effect of SVF derived     MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and     graft survival. 120 patients eligible for the study as described below will be enrolled, with     60 patients in intervention group and 60 in control group.   "
60591|NCT02492477|"     The benefits and risks of flushing or not flushing the non-used PORT-A-CATH® in cancer     patients and the time interval of eventual PORT-A-CATH® flushing are currently unknown. The     manufacturers of PORT-A-CATH® recommend regular flushings every 4 weeks. In clinical     practice, the intervals are usually at least three months. Regular flushing might lead to a     decreased risk of PORT-A-CATH® thrombosis, but may also lead to an increased infection or     thrombosis rate and patients discomfort. Therefore, this study investigates the safety of not     flushing the PORT-A-CATH® for 6 or 12 months.   "
60592|NCT02492464|"     This will be a double-blind randomized clinical trial carried out on subjects with suboptimal     control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast     rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate     the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R)     apparatus)   "
60593|NCT02492451|"     The investigators will try to assess the effect of endometrial injury preceding the     intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase     support and the control group.   "
60594|NCT02492438|"     To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine     as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients     treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23     vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52     weeks.   "
60595|NCT02492425|"     The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP     and HCAP in real life of China   "
60596|NCT02492412|"     The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the     patients with moderate to severe dry eye syndrome.   "
60597|NCT02492399|"     The purpose of this study is to determine whether the application of the extended myoectomy     in patients with obstruction of the left ventricular output more efficient than standard     myoectomy by Morrow.   "
60598|NCT02492386|"     In this prospective, unblinded, single-arm, single-center study, investigators would like to     assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients     with erectile dysfunction and concomitant internal pudendal artery stenoses. A total of 15     bioabsorbable vascular scaffolds (BVSs) are planned to be assessed and will be deployed in     the internal pudendal artery, with a 1:1 ratio of both proximal and distal segments.   "
60599|NCT02492373|"     To investigate the benefit of the application of topical high potency steroid on the     incidence of post inflammatory hyperpigmentation after laser treatment.   "
60610|NCT02492230|"     The objective of Left atrial appendage closure compared to standard antiplatelet therapy in     patients with AF who underwent percutaneous coronary intervention (LLA-PCI) study is to     evaluate the safety and efficacy of implantation of left atrial appendage closure compared to     standard antiplatelet therapy for prevention of thromboembolic events and stent thrombosis in     subjects with AF who underwent PCI.   "
60611|NCT02492217|"     To identify new candidate genes and proteins that are differentially expressed in responders'     vs non-responders to anti-TNF alpha therapy at the several time points the investigators will     use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and     protein markers regarding prediction to anti-TNF alpha therapy efficacy.   "
60601|NCT02492347|"     Selective Serotonin Reuptake Inhibitors (SSRIs) are a group of antidepressants that suppress     the re-absorption of a chemical called Serotonin in the brain, and improve mood. SSRI use in     the treatment of mental health problems has increased greatly since their introduction in the     1980's. When given in pregnancy they cause less fetal effects than other antidepressants.     However they are still known to cause premature birth, heart defects and withdrawal symptoms     in the baby. Withdrawal symptoms can occur in up to 30% of exposed babies, where as heart     defects have been found to increase by 2-3 times against the normal rate of 1%. There is very     limited information available, but it is also thought it may cause lengthening of a certain     portion of the heart beat, the QT interval, which has been shown to lead to sudden death in     adults. The QT interval will be looked at in this study, comparing babies exposed to SSRIs in     pregnancy with unexposed babies.      The study will be based in the United Kingdom (UK), at the Maternity Unit of a District     General Hospital, and will be carried out over 12-18 months.      A group of babies whose mothers took SSRIs whilst pregnant will have an Electrocardiogram     (ECG) done when they are 2-3 days old. These will be compared with babies whose mothers did     not, but whose babies were still in hospital because they were at risk of having an     infection, but were found to be healthy.      The study hopes to see whether there is a link between SSRI use in pregnancy and lengthening     of the QT interval and if so, extra surveillance may be considered for this group of babies.   "
60602|NCT02492334|"     The study will test the efficacy of doxazosin, a long-acting and selective alpha-1 adrenergic     antagonist, as compared to placebo in reducing PTSD symptomatology and alcohol use severity.   "
60603|NCT02492321|"     This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel     group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to     vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to     severe allergic conjunctivitis (AC) three times daily for 4 weeks.      Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled     into the study.   "
60604|NCT02492308|"     The objective of this trial is to determine if autologous SVF derived MSC can effectively     reduce the need for post transplant immunosuppressant in living-relative kidney     transplantation. 120 patients eligible for the study as described below will be enrolled,     with 60 patients in intervention group and 60 in control group.   "
63622|NCT02452853|"     Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most frequent     cause of cancer death worldwide. Hepatic resection (HR) is the conventional ''curative''     treatment for HCC. In both the European and the United States Proposed Guidelines for HCC, HR     is recommended only for patients with preserved liver function and with early stage HCC.     Unfortunately, because of tumor multifocality, portal vein invasion, and underlying advanced     cirrhosis, only 10% to 30% of HCCs are amenable to such a ''curative'' treatment at the time     of diagnosis. Transarterialchemoembolization (TACE) has become the most popular palliative     treatment for patients with unresectable HCC, and it is no longer considered as a     contraindication to HCC with portal vein tumor thrombus (PVTT). Unfortunately, the long-term     outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT. To     improve on the results of treatment of HCC with PVTT, attempts have been made to perform HR     for these patients. HCC with PVTT remains a contraindication to liver transplantation because     of the high rate of tumor recurrence, and because of the severe shortage of donor organs. HR     remains the only therapeutic option that may still offer a chance of cure. With advances in     surgical techniques, it has become feasible to remove all gross tumors, including PVTT, which     has extended to the main portal vein, safely by surgery. More HCC with PVTT, which previously     were considered as unresectable, have become resectable.Recent studies have even shown     favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. However,     the recurrence rate after HR for PVTT is still high and the prognosis for patients with HCC     with PVTT is very poor. Systemic chemotherapy is considered to be one of the main treatments     for malignant tumors. HCC is known to be highly refractory to conventional systemic     chemotherapy because of its heterogeneity and multiple etiologies. Before the advent of the     molecular-targeted agent sorafenib, which has subsequently become the standard of care, no     standard systemic drug or treatment regimen had shown an obvious survival benefit in HCC.     Nowadays, there is no systemic chemotherapy regimen had been definitively recommended as the     standard for treating HCC. Clinical activity of several regimens containing oxaliplatin (OXA)     in advanced HCC had been demonstrated in phase II studies. In a phase II study of the FOLFOX4     (infusional fluorouracil [FU], leucovorin[LV], and OXA) regimen in Chinese patients with HCC,     median overall survival (OS) was 12.4 months, mean time to progression was 2.0 months, and     the response rate (RR) was 18.2%. The safety profile was acceptable. Recently, the results of     a phase Ⅲ randomize study showed that FOLFOX4 served as palliative chemotherapy can induce     higher overall survival, progression-free survival and response rate comparing to doxorubicin     in patients with advanced hepatocellular carcinoma from Asia. The safety data was also     acceptable.So the investigators' hypothesis is that post-surgery FOLFOX4 can reduce high     recurrence rate after HR for HCC with PVTT. The aim of this open-label, single prospective     study is to evaluate the efficacy and safety of HR combined with FOLFOX4 systemic     chemotherapy for patients with HCC with PVTT.   "
60605|NCT02492295|"     Migraine headache is a frequent Emergency Department complaint. While first-line Emergency     Department treatment for this condition is well-established, optimal second-line treatment     options are not well-defined. First line Emergency Department treatments include     Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), dopamine antagonists. Second line treatments     that have been proposed include triptans, steroids, antiepileptics, benzodiazepines,     magnesium and narcotics, but none have shown reliable Emergency Department efficacy (less     than 50% in most studies). In the past ten years there have been several case series     published on using low, sub-anesthetic doses of propofol for the treatment of refractory     migraine. These case series have reported very impressive efficacy rates, especially in     comparison to the published efficacy rates of other second-line treatments. Personal     experience using this treatment modality has also yielded impressive clinical results. Most     of the published series, however, have not been conducted in the Emergency Department.      The Investigators propose to conduct a prospective, observational trial of low-dose propofol     for the treatment of refractory migraine in the Emergency Department. Propofol is a     frequently-used Emergency Department sedative, with a good safety profile when administered     by experienced Emergency Medicine practitioners using appropriate monitoring. The primary     outcome measurement will be reduction of pain after treatment, with secondary outcome     measures related to the safety of treatment and continuation of pain relief after leaving the     Emergency Department. Although the protocol will involve the use of low-dose propofol with     the aim of achieving light-to-moderate sedation only, all patients will care for and monitor     at a level appropriate for deep procedural sedation.   "
60606|NCT02492282|"     Closed loop system in intravenous anesthesia is more effective to maintain depth of     anesthesia compared with manual system open, it is unclear what driver and variables to     achieve this goal be more physiological; in the literature doesn´t exist studies showing that     the closed-loop system for both hypnotic and opioid is better than the controlled     pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain     anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in     closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for     propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was     integrated an additional closed system for remifentanil using hemodynamic variables and     control algorithm associated with bispectral index.      The purpose of this study is to determine the therapeutic effectiveness of a new system of     administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia     compared to an open loop system TCI.   "
60607|NCT02492269|"     The overall goal of this project is to determine the role of anesthetic management in     children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early     extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress     response as would be evident by the stress markers levels and the level of two cerebral     injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative     outcome and hopefully improve both the short and the long term neurodevelopmental outcome in     these children. The project is prospective, randomized and blinded study. The first and     second aim of the study should be conducted over 2 year period. Our long term aim will be     concluded when these children reach the school age.   "
60608|NCT02492256|"     Although circumferential pulmonary vein isolation (PVI) has been considered as the     cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate.     The investigators designed a prospectively randomized study to evaluate whether additional     atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical     outcome in patients with persistent AF.   "
60609|NCT02492243|"     The trial will inform whether detection of ventricular arrhythmias by means of implantable     loop recorder (ILR) can help to predict SCD in the large population of survivors of a     myocardial infarction with preserved left ventricular function, EF>40%. This may improve risk     stratification in these patients, and can inform on the clinical use of subcutaneous monitors     to identify post-infarction populations in need for an intervention to prevent sudden death.   "
60613|NCT02492191|"     Introduction Day surgery is a well-established practice in many European countries, but only     limited information is available regarding postoperative recovery at home though there is a     current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is     also a need for improvement of modern technology in assessing patient related outcomes such     as native software applications. This article describes the RAPP study protocol, a     mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing     day surgery is cost effective and improves postoperative recovery, health and quality of     life.      Methods and analysis This study is a mixed-methods study design that includes a multicenter,     two-group, parallel, single-blind randomized controlled trial (RCT) and qualitative interview     studies. One thousand patients >17 years of age who are undergoing day surgery will be     randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days     measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR)     or to standard care (i.e. no follow up). The primary aim is cost effectiveness. Secondary     aims are improvements on postoperative recovery, health-related quality of life (QoL) and     overall health; (b) to determine whether differences in health literacy have a substantial     and distinct effect on postoperative recovery, health, and QoL; and (c) to describe day-care     patient and staff experiences with a systematic e-assessment follow-up after day surgery.The     primary will be measured at 2 weeks postoperatively and secondary outcomes b) at 1 and 2     weeks and c) at 1 and 4 months.   "
60614|NCT02492178|"     The study aims at describing the pharmacokinetic properties of rectal artesunate in well     characterized severely ill patients using intravenous artesunate as a comparator.   "
60615|NCT02492165|"     The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult     and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity,     reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data     from other Asian pediatric populations.      Primary objective:      - To describe the safety profile of a single dose of IMOJEV®.      Secondary objectives:        -  To evaluate the immune response to JE 28 days after the administration of a single dose          of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.   "
60616|NCT02492152|"     The purpose of the study is to see whether the use of DIANATAL during active labor, reduces     the rates of episiotomy and vaginal tears.   "
60617|NCT02492139|"     The overall purpose of this study is to evaluate the reliability and usability of the     reusable BrownieForSymphony pump set in home use.      The primary objectives of this study is to asses and compare the System Usability Scale (SUS)     score of the BrownieForSymphony pump set and the current used Symphony pump set.      Secondary Objectives      The secondary objectives of this study are:      to evaluate the rate of usability problems with the BrownieForSymphony pump set        -  to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump          set        -  to evaluate perceived comfort during pumping with the BrownieForSymphony pump set          Prospective Cohort Study (quasi Cross over design)   "
60618|NCT02492126|"     To determine whether contraction abnormalities in the esophagus plays a role in     gastroesophageal reflux induced cough, and thus cough severity in patients with chronic     cough.   "
60619|NCT02492113|"     The main purpose of this study is to define at the bedside the Titrated-PEEP level for     obese patients that increases the likelihood of extubation and ventilator liberation.      The investigators hypothesized that a titrated level of PEEP (Titrated-PEEP) during SBT     will keep the lung recruited, maintain oxygenation, and decrease the work of breathing     resulting in successful ventilator liberation. In addition, post-extubation the investigators     hypothesize that these patients will require noninvasive ventilatory support in the form of     CPAP at the level of titrated-PEEP used during the SBT.   "
60620|NCT02492100|"     This research study is evaluating the feasibility and impact of an intervention to improve     sexual function in stem cell transplant survivors on participants' sexual function, quality     of life, and mood.      - It is expected that about 50 stem cell transplant survivors will take part in this research     study.   "
60621|NCT02492087|"     The objective of this study is to investigate whether topical application of tranexamic acid     into the uterine cavity and the surgical site intra-operatively can reduce blood loss and     provide better surgical haemostasis in parturients with moderate to high risk for bleeding     undergoing caesarean deliveries.   "
60622|NCT02492074|"     The study evaluates the gene-environment interaction of the COMT-genotype on the effects of     the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on     induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal     processing, and neural oscillations. In addition the effects of the phytocannabinoids on     lipid levels in serum and cerebrospinal fluid, cognition, neuronal processing assessed by     fMRI as well as D2-receptor availability assessed by [18F] desmethoxyfallypride.   "
60623|NCT02492061|"     This study aims at assessing the effect of a demand-creation intervention on couples' HIV     counseling and testing (couples' HCT) uptake among married couples who have never tested     together as a couple. The study is being implemented in 12 clusters; six intervention and six     comparison clusters. A total of 1,538 couples will be enrolled into the study; 769 couples     per arm. Couples in the intervention communities are invited to participate in small group,     couple-focused or men-only, interactive sessions lasting 3-4 hours in which the advantages     and fears associated with couples' HCT are discussed with invited couples to motivate them to     consider testing together as a couple. The meetings are reinforced with testimonies from     previously tested couples. At the end of the sessions, couples or men receive invitation     coupons which they present to a designated health facility to receive couples' HCT services     (couples are free to receive individual HCT or not to honor the invitation, if they are not     interested in taking the HCT offer). In the comparison communities, standard of care health     education activities including general adult community sessions are held but couples do not     receive any invitations to test as a couple. Nevertheless, couples in the comparison     communities have unlimited access to HIV counseling and testing services that are offered by     the Rakai Health Sciences Program within the study communities. The investigators hypothesize     that couples in the intervention arm will be more likely to test together than those in the     comparison arm. The study objectives include: a) exploring the motivations for and barriers     to couples' HCT uptake; b) assessing the effect of a demand-creation intervention on couples'     HCT uptake among married couples with no prior couples' HCT experience, and c) exploring the     effect of couples' HCT vs. individual HCT on linkage to and retention in HIV care.   "
60624|NCT02492048|"     This is multi-center prospective, longitudinal case series with comparison to historical     controls.   "
60644|NCT02491788|"     The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting     drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight     shifts will significantly improve both objective (total sleep time, sleep efficiency, wake     after sleep onset) and subjective (sleep quality) measures of daytime sleep.   "
60625|NCT02492035|"     The Canadian hypertension education program recommends increased physical activity, adoption     of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and     alcohol intake for treatment and prevention of hypertension. Objective: To describe patients     participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a     family medicine primary care setting. Design: Descriptive study. Participants: The study aims     to recruit 60 sedentary hypertensive patients to participate in a 6-month     randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary     (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood     pressure measurements [ABPM]), non-smoker, non-diabetic and without dyslipidemia.     Intervention: Patients are recruited by health care professionals of the family medicine unit     and are thereafter randomized to one of four intervention groups: 1) standard medical care     (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet and     physical activity. Patients are evaluated (pre, mid and post intervention), monitored, and     educated by the interdisciplinary health care team that includes a physician, a     kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and     descriptive statistics were used to analyse data. This study will document the efficacy of a     primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.   "
60626|NCT02492022|"     Quitting smoking is a big decision, a decision to achieve better health. Trying to quit     smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure     to change the routine, can also be sources of stress.      Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability,     hunger and cravings for more tobacco. Nicotine creates a dependency so that the body develops     a need for a certain level of nicotine at all times. Unless that level is maintained symptoms     of withdrawal appear.      For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and     stressful, but they are temporary.      Research has demonstrated the relative effectiveness of pharmacotherapy treatments in smoking     cessation but no studies have examined the effects of the probiotics on the withdrawal     symptoms associated with the tobacco cessation during nicotine replacement therapy (NRT).      The purpose of this study is to assess the effectiveness of two probiotic products during NRT     for managing withdrawal symptoms associated with smoking cessation.   "
60628|NCT02491996|"     The investigators proposed a desire satisfaction-targeted intervention for disordered     gamblers (DTIG) due to the limitations of the abstinence-targeted intervention, which is     based on the weak self-control relative to growing desire to gamble. This intervention model     perceives loss of gambling control as a failure of strategy in which gambling is anticipated     to fulfill various desires (i.e., desires for fame, money, and escapism). Therefore, the     alternative behaviors to fulfill original desires directly become the main therapeutic     purpose.      Materials and Methods: Outpatients who were primarily diagnosed as gambling disorder by the     DSM-V were treated by DTIG. This method usually comprised 1 or 2 sessions, 60 minutes in     duration, delivered by a psychiatrist. Participants were examined : 1) Basic background such     as gender, age,; 2) medical variables such as the onset age, the duration of the problem     gambling, psychiatric complications, motivation to quit gambling; 3) assessment of severity     (DSM-5, SOGS and G-SAS); 4) Short prognosis; 6 months-outcome after intervention (problem     gambling/ control gambling/ abstinence).   "
60629|NCT02491983|"     This is an international, randomized, open-label, controlled, multicenter phase II clinical     trial to investigate and compare the safety and efficacy of palbociclib combined with     fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast     cancer.   "
60630|NCT02491970|"     The purpose of this study is to demonstrate superiority of Fluticasone/Formoterol     (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the     Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA     concomitant treatment.   "
60631|NCT02491957|"     The purpose of this study is to evaluate the safety and feasibility of LOFT Therapy in breast     cancer survivors. In a previous study, the investigators found that many patients are more     debilitated at diagnosis than previously recognized. Both chemotherapy and anti-estrogen     therapy have a large effect. Within 6 months patients replace muscle with fat leading to a     significant reduction in muscle power and endurance. Our data suggests that common exercise     recommendations for at least 150 minutes of exercise a week would be far beyond many of our     patients' physical ability after therapy, leading to the soreness, injury, frustration, and     early discontinuation (or failure to initiate an exercise program in the first place). The     degree of muscle loss seen in our patients is similar to that documented in US astronauts     after long-term space flight. Our collaborator Dr. Yvonne Cagle, retired USAF flight surgeon,     noted that the cosmonauts were in better shape (had less muscle atrophy) than the astronauts.     This difference was more than could be explained by the rigorous Russian exercise program.     The only key distinction was the compressive, penguin suits used by the Russians. This     observation lead Dr. Cagle to develop a technique called low intensity, off     loaded-compressive therapy (LOFT) to replicate the impact of the Russian penguin suits for     patients who were debilitated, whether by space flight or by chronic conditions such as     arthritis, Parkinson's disease, and multiple sclerosis. The LOFT method does not require     excessive exertion or strain on the joints. In field observations, LOFT therapy improved     muscle strength, muscle mass, endurance, sleep quality, and fatigue. This pilot study is the     first to evaluate the safety, feasibility, and biologic impact of LOFT on breast cancer     survivors.   "
60643|NCT02491801|"     The proposed study is planned to determine the potential role for regular fat dairy products     in short-term metabolic control in younger and older adults and the metabolic flexibility in     response to food components, which are areas that have not yet been explored. Subjects would     be served with solid (cheese), semi-solid (yogurt) and liquid (milk) dairy products and skim     milk (control) and water (non-caloric control), 2 hours before consumption of ad libitum     pizza meal in 5 consecutive sessions.   "
66752|NCT02411994|"     The purpose of this study is to determine the efficacy of pyronaridine-artesunate and     artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in     Kenyan children.   "
60632|NCT02491944|"     The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall     cell lung cancer. Lung cancer has been the most common cancer in the world for several     decades and represents 12.8% of all new cancer cases in 2008.      The purpose of this study is to see how much AZD9291 is taken up by the body when dosed by     mouth (tablet) compared to when the study drug is dosed once by injection directly into the     vein (intravenously). The dose given directly into the vein will be radiolabelled. This means     that the test drug has a radioactive component which helps us to track where the drug is in     the body. This allows us to detect the differences between the tablet and the intravenous     dose.      The study will be performed in 12 healthy male subjects aged 18-65 years. On Day 1, subjects     will be dosed with a single oral dose of 80 milligrams AZD9291 tablet followed by 100     micrograms [14C] AZD9291 dosed as an intravenous microdose beginning 5 hours and 45 minutes     after the oral dose has been administered. Subjects will remain in the study centre until     after the 120 hour post-dose blood sample is obtained and will return to the clinic for     further visits on Day 8, 10, 15 and 22 for pharmacokinetic and safety assessments.   "
60633|NCT02491931|"     Introduction: Glutamine (GLN) is the most abundant free amino acid in the body. It modulates     immune cell function and is an important energy substrate for most cells (especially for     enterocytes and lymphocytes) in critical patients. GLN levels significantly decreased during     sepsis/critical illness leading to an increase in infectious complications, organ failure and     mortality. Moreover, in cases of ischemia/reperfusion injury in the myocardium, GLN increases     the levels of Adenosine triphosphate (ATP)/Adenosine diphosphate (ADP) ratio and prevents     intracellular lactate accumulation. Recently, the perioperative effect of intravenous and     oral GLN treatment been associated in lowering levels of cardiac injury markers such as     Troponin-I (TROP-I) and the number of postoperative complications in patients who underwent     Cardiopulmonary Bypass (CPB). The aim of the study was to analyze the oral dose of     preoperative oral GLN treatment in patients who underwent CPB with extracorporeal circulation     in Mexican patients.   "
60634|NCT02491918|"     This prospective, randomized, clinical trial looks to compare children undergoing congenital     cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration     as well as postoperative complications such as glaucoma, inflammation and IOL centration when     IOL fixation is performed using two different techniques : 1) conventional in the bag IOL     implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the     posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to     receiving IOL implantation using one of the two techniques will be followed up until 12     months postoperatively.   "
60639|NCT02491853|"     This is a prospective observational multi-center multi-national study of the characteristics     and outcomes of patients receiving implantable cardioverter-defibrillators (ICD) in the Arab     Gulf region. A total of 1,500 patients will be enrolled. Data on baseline clinical     characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as     mortality and ICD discharges over 1 year of follow-up will be collected.   "
60640|NCT02491840|"     Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with     disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not     respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay     their surgical management. The completion of chemotherapy for these patients would be a bad     prognosis factor according to recent data from the literature. Therefore, the aim of this     research is to find prognostic markers of sensitivity to chemotherapy usually performed. The     investigators are going to use biopsies realized at diagnosis and select patients good and     bad responders.      Primary purpose:      To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative     chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation      Secondary purposes:        -  To assess the impact of patients' lifestyle (via a questionnaire) on the response to          chemotherapy        -  To study markers of cancer stem cells        -  To correlate clinical and molecular markers with patient survival and quality of life          questionnaires        -  To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in          frequently deregulated genes in gastric cancers.        -  To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73,          HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.        -  To correlate the abnormalities found in the with tumor stages (before and after          chemotherapy) and with 5 years overall survival and progression-free patients   "
60641|NCT02491827|"     Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE,     also named 'optical biopsy') might improve the results of medically necessary neurosurgery to     prove practicability, safety and harmlessness of CLE during neurosurgical procedures   "
60642|NCT02491814|"     This study investigates the effects of commercially-available dairy (1% cow's milk and yogurt     beverage) and non-dairy alternatives (almond and soy beverages) on satiety and post-meal     blood glucose. Each participant will receive every treatment in this crossover design study.   "
60674|NCT02491398|"     This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a     first or second treatment with drugs named bendamustine and rituximab. It will observe the     results of this treatment and evaluate its efficacy and side effects.   "
60645|NCT02491775|"     The investigators propose to conduct a pilot feasibility study of single agent afatinib in     patients with previously untreated metastatic EGFR (epidermal growth factor receptor) mutant     adenocarcinoma of the lung (NSCLC = non-small cell lung cancer) with the sole purpose of     characterizing the genomic landscape before afatinib and at the time of disease progression.   "
60646|NCT02491762|"     This study evaluates the effect of breast reconstruction surgery on respiratory functions. 45     patients elected for unilateral or bilateral breast reconstruction surgery will go through     respiratory function examinations a month prior to the surgery, one month after surgery and     three months after surgery.   "
60647|NCT02491749|"     Ultra-fast track anaesthesia (UFTA) aims at immediate extubation of cardiac surgical patients     at the end of the operation. This study compares the effect of UFTA versus continued     postoperative mechanical ventilation on the ICU length of stay (LOS).      Methods. Fifty two elective adult patients were randomly allocated into UFTA and conventional     groups by computer-generated random numbers. Redo operations, pre-operative intubation,     uncontrolled diabetes, shock/LVEF <45%, PASP >55mmHg, creatinine clearance <50 ml min-1,     haemodynamic instability, or those with concerns of postoperative bleeding were excluded.     Pre- and intra-operative management was similar and Logistic EuroSCORE II was calculated for     all. Intra-operatively, haemodynamic parameters, urine output, SPO2, arterial blood gas     analysis (ABG), 5-lead ECG, operative- bypass- and cross clamp time, and opioid consumption     were collected.      Postoperatively, patients were compared during their ICU stay. Data were analysed by     χ²/Fischer exact, unpaired student's t-test, univariate two-group repeated measures ANOVA     with post hoc Dunnett's test, and Mann-Whitney U tests as appropriate. p<0.05 was considered     significant.   "
60648|NCT02491736|"     The aim of this study is to analyse the effect of ketoprofen gel in children presented with     ankle sprain to the emergency department.   "
60649|NCT02491723|"     It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence     against viral and bacterial stimuli by modulating the immune response. The aim of this study     was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate     whether macrolide attenuate its levels.   "
60650|NCT02491710|"     Training is of great importance in laparoscopy. There are different commercially available     trainers which are quite expensive and are used by trainees only inside the hospital.      The aim of this study is to find out whether basic laparoscopic skills training using an     inexpensive tablet-based laparoscopic box trainer leads to equal training results (=     improvement of skills) compared to practicing with a conventional commercial box trainer.     Furthermore, trainee satisfaction with this home-made alternative compared to the standard     trainer will be assessed.   "
60651|NCT02491697|"     The prognosis of advanced breast cancer does not improve much recently although varies of     adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer     cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its     role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the     efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine     monotherapy for the treatment of advanced breast cancer.   "
60652|NCT02491684|"     A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent     or reduce the severity of asthma attacks when administered to asthma patients at the onset of     symptoms of common cold or influenza   "
60787|NCT02489916|"     The investigators do the clinical trial (patients with metastatic colorectal cancer treated     with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib     in patients with metastatic colorectal cancer, progressing after all approved standard     therapies.   "
60653|NCT02491671|"     The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection     procedures remains unproved. The investigators hypothesize that one of the main reasons for     that is the heterogeneity of previously studied populations. Since currently the risk of     postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to     investigate the effect of routine application of a novel tissue sealant in patients selected     on the basis of a high risk of PAL estimated before surgery.   "
60654|NCT02491658|"     The purpose of this study is to investigate the safety and efficacy of umbilical cord derived     mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any     adverse events related to UC-MSCs infusion will be monitored and the patients will be     assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index     (DLQI) in the baseline and after MSCs infusions.   "
60655|NCT02491645|"     Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory     processing abnormalities .Tackling these problems would help in better quality of life, both     for the parents and the children. Sensory integration therapy, an individualized clinic based     therapy have been shown to have a positive effect on those children with sensory     abnormalities. Hence the investigators are doing this study , to primarily look into the     efficacy and feasibility of home based sensory interventions in autistic children with     sensory processing abnormalities.   "
60656|NCT02491632|"     The goal of this clinical research study is to learn about the effects of combining physical     activity with dexamethasone to treat fatigue in patients with advanced cancer.   "
60657|NCT02491619|"     The correlation between tooth inclination and bone thickness and the comparison between     thickness measurements and buccolingual inclination before and after dental decompensation     will be evaluated through tridimensional images in individuals with class III dentofacial     deformities.   "
60658|NCT02491606|"     This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR     238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum     malaria in Nyanza Province, western Kenya.   "
60659|NCT02491593|"     The aim of this study is to compare the outcome of three (3) quantitative immunochemical     faecal occult blood test in symptomatic patients.   "
60660|NCT02491580|"     Patients with previous malignancies have increasingly been accepted for renal     transplantation. However, post-transplant malignancy risk and survival rates of these     patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily     high risk of post-transplant malignant tumours and if the organs as a resource are too     limited for investment in this patient group.   "
60675|NCT02491385|"     The investigators try to find whether thoracic epidural analgesia (TEA) shortens the first     gas-out time compared to iv-PCA and promotes earlier discharge after major upper abdominal     surgery.   "
60661|NCT02491567|"     Hashimoto Thyroiditis (HT) and Graves Disease (GD) are known to be caused by abnormal immune     response against self cells and tissues. Epigenetics is a novel field of biology studying the     mechanisms by which the environment interacts with the genotype to produce a variety of     phenotypes through modifications to chromatin that do not directly alter the DNA sequence. A     very limited number of epigenetic studies have been published in patients with HT and GD so     far. Therefore, the purpose of this study is to analyze DNA methylation status in White Blood     Cells (WBCs) within the promoter regions of genomic sites that have been previously     identified as susceptibility loci or sites for autoimmune thyroid disease, such as the CD40,     FOXP3, CTLA4, PTPN22, CD25, and TPO genes.   "
60662|NCT02491554|"     This is a monocentric, randomized, controlled, 2 arms, interventional, observer-blinded     feasibility trial.      Patients suffering from essential tremor (ET) will be treated with Deep Brain Stimulation     (DBS). For the implantation of the DBS electrodes and the DBS system (Activa INS, Medtronic)     patients will randomized either to conventional stereotactic surgery of thalamic/subthalamic     region with short anesthesia or to MR-tractography guided stereotactic surgery with target     point of the dentato-rubro-thalamic bundle (DRT) in general anesthesia.      Patients will visit the study center at screening, baseline/neurosurgery, six and twelve     months after neurosurgery.   "
60663|NCT02491541|"     The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study     is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in     healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1)     vaccination.   "
60664|NCT02491528|"     This is a multicenter, randomized, open, parallel group, active-controlled study. The study     period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24     weeks.   "
60665|NCT02491515|"     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone     turnover makers, and fracture prevention effects of denosumab in Japanese patients under     clinical practice. The participants are treated in the investigators hospital, who are under     severe osteoporotic condition.      The main objective of this study is to investigate effects of denosumab. The researchers also     investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment.     In this study, the investigators analyse the determinants of subsequent BMD increase and     fracture preventing effect by teriparatide.   "
60666|NCT02491502|"     This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules     with the FastScan version using assessment of patient experience and adverse event reporting.   "
60680|NCT02491320|"     This is a study protocol for a multicenter, randomized, and controlled trial. In this     protocol, we present a randomized controlled trial comparing acupuncture pretreatment     followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with     anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS     women is considered to be one of the major pathophysiological changes of PCOS, leading to     anovulatiory infertility. A study has shown that electro-acupuncture could significantly     improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women     followed by ovulation induction has not been investigated before. A total of 384 patients     enrolled in this study will be randomized into one of two groups. The treatment group: a 16     week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4     cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that     acupuncture pretreatment followed by letrozole results in a higher live birth rate when     compared with letrozole alone.   "
60667|NCT02491489|"     Shoulder pain is one of the most common musculoskeletal conditions treated by physical     therapists. One common treatment is passive glenohumeral joint accessory mobilization, which     is the application of a therapist generated force to move the humeral head (ball) on the     glenoid (socket) of the shoulder to improve motion and decrease pain. It is generally     accepted that these mobilizations do not elicit active muscular contractions of the     surrounding musculature. However, there is very little literature to support this assumption,     and a preliminary PubMed search utilizing the terms shoulder, mobilization, and EMG     returned zero relevant references. Therefore, the investigators plan to utilize surface     electromyography (EMG), a non-invasive assessment tool, to objectively measure the activity     of the rotator cuff muscles (the muscles that surround the shoulder and provide stability to     the joint) during various grades(levels of force and amplitude of movement) of glenohumeral     mobilization ( a standard of care treatment). It is also unknown if subjects pain levels     impact the level of rotator cuff activity. To investigate these questions, the investigators     will collect EMG data while performing mobilizations on a total of 20 subjects, divided into     two groups: 10 pain free shoulders and 10 painful shoulders. Data analysis will then include     descriptive analysis, estimates of effect size, and analysis for between group differences.      The investigators hypothesize that there will be significant differences in muscular activity     between groups related to the presence of shoulder pain.   "
60668|NCT02491476|"     The main objective of this study is to evaluate the feasibility of recording fast-ripples, a     potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by     Dixi-Medical.   "
60669|NCT02491463|"     The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity     and immunogenicity of 2 doses of the RSV investigational vaccine, when administered     intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.   "
60670|NCT02491450|"     Comparative randomized, single dose, two-way crossover open-label study to determine the     bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt)     versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human Volunteers Under     Fasting Condition.   "
60671|NCT02491437|"     The purpose of this randomized, two-arm and open label study is to demonstrate that the     treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the     daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who     are unable to conceive a child and are undergoing IVF. The treatment will start on the day of     oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.      Patients will be followed during treatment until 30 days after delivery to record any safety     and tolerability data of the patient and their newborn (s).   "
60672|NCT02491424|"     Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an     Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).   "
60673|NCT02491411|"     This pilot trial studies how well dexamethasone and re-treatment with enzalutamide work in     treating patients with prostate cancer that has spread to other places in the body     (metastatic), does not respond to hormone therapy (hormone-resistant), and was previously     treated with enzalutamide and docetaxel. Dexamethasone treatment may be able to reverse one     resistance mechanism to enzalutamide therapy (overabundance of receptors for dexamethasone     and other glucocorticoids inside cancer cells) and allow for renewed therapeutic sensitivity     to enzalutamide. Androgens (a type of male hormone) can bind to androgen receptors found     inside prostate cancer cells, which may cause the cancer cells to grow. Enzalutamide may stop     the growth of prostate cancer cells by blocking the activity of the cancer cell androgen     receptors. Giving dexamethasone prior to re-treatment with enzalutamide may be a treatment     for prostate cancer.   "
60676|NCT02491372|"     This pilot research study aims to assess the effectiveness of an Acceptance and Commitment     Therapy (ACT; Hayes Strosahl & Wilson, 2011) group based intervention at improving quality of     life (QOL) and increasing Psychological Flexibility with survivors of Upper GI cancer     following curative treatment. Participants will be invited to take part in an eight week     intervention with outcomes being measured at baseline, midpoint, post-intervention and two     month follow up. Outcomes will be compared with a randomised control group who will receive     treatment as usual. Research has indicated that this population are under considerable     psychological distress however within the UK there are currently no specifically tailored     psychological interventions on offer to reduce this distress (Dempster, McCorry, Brennan,     Donnelly, Murray & Johnston, 2012).   "
60677|NCT02491359|"     This pilot phase II trial studies how well carfilzomib works in treating patients with     chronic graft-versus-host disease. Chronic graft-versus-host disease is a complication of a     donor bone marrow or blood cell transplant, usually occurring more than three months after     transplant, in which donor cells damage the host tissue. Carfilzomib may be an effective     treatment for chronic graft-versus-host disease.   "
60678|NCT02491346|"     Poor glycemic control in critically ill patients can increase their mortality, while safe and     efficient glucose control is laborious and time-consuming. The Space GlucoseControl which is     installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range     safely and effectively through regulating insulin dose rate. This study is a random     controlled trial involving the patients with mechanical ventilation in intensive care unit in     order to evaluate the difference of safety and efficacy of blood glucose control between SGC     directed and conventional treatment. At last, the trial results can determine whether the     Space GlucoseControl can control blood glucose safely and effectively in the patients with     mechanical ventilation in intensive care units.   "
60679|NCT02491333|"     The objectives of this randomized controlled trial are to compare insulin sensitivity     following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo     metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR.   "
60700|NCT02491047|"     This is a prospective, multi-national, multicenter, randomized, two arms, single blind,     Standard of Care (SOC) controlled, with blinded central reading center study. This study will     assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo     IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.   "
60834|NCT02489292|"     The aim of the study is to assess the efficacy of HepaStem treatment in paediatric patients     suffering from urea cycle disorders.   "
60681|NCT02491307|"     This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for     medically-underserved patients with mood disorders (e.g. depression, anxiety, bipolar) cared     for in a large statewide community health center. The primary goal of the Study is to reduce     emergency room (ER) visits, hospitalizations, and to look at changes in service utilization     by using the Ginger.io platform to enhance communication between behavioral health providers     and their patients, increasing the early detection of exacerbations in mood disorders (e.g.     depression, anxiety, bipolar) and proactive outreach. The secondary goal is to improve     clinical & behavioral health outcomes.   "
60682|NCT02491294|"     Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research,     extension, and education project targeting 4th grade students. Its long-term goal of reducing     the risk of childhood obesity will be addressed by promoting healthful food and activity     environments, policies and behaviors through: 1) building and testing the efficacy of a 4th     grade comprehensive school- and family-based intervention, 2) applying it to an after-school     setting to broaden its reach, and, 3) disseminating both versions through outreach.   "
60683|NCT02491281|"     This study is designed to evaluate the safety and tolerability of ascending single doses of     LNA043 given intra-articularly into the human knee joint prior to its removal at total knee     replacement surgery. In addition, this will help to establish the presence of LNA043 within     the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow     exploration of biomarkers of hyaline cartilage repair.   "
60684|NCT02491268|"     Epidemiological, clinicopathological and animal studies show that vascular disease in various     forms contributes to cognitive decline. Increasing age is the strongest risk for dementia     irrespective of whether it results from a vascular etiology or neurodegenerative disease     processes such as in Alzheimer's disease (AD). AD and vascular cognitive impairment, the two     most common causes of dementia, represent two extremes of a spectrum of disorders; however, a     number of entities, which possess varying degrees of neurodegenerative and vascular     pathologies, occur in between. The pure forms of the disorders are preferred for convenience     to label, treat or manage but conditions within the spectrum are the norm rather than the     exception as dementia advances. Therefore, combinatorial therapy directed at both vascular     and neurodegenerative aspects of dementia is a promising approach for the treatment of     dementia in the elderly.      Cilostazol acts as an antiplatelet agent and has other pleiotropic effects based on     phosphodiesterase-3-dependent mechanisms. Increasing evidence suggests that cilostazol offers     endothelial protection, via pleiotropic effects. Intriguingly, cilostazol has been shown to     decrease amyloid beta (Abeta) accumulation and protect Abeta-induced cognitive deficits in an     experimental model. In a pilot study of 10 patients with moderate AD (mean MMSE score, 11.9     points) who received donepezil, cilostazol add-on treatment for 5-6 months demonstrated     significantly increased MMSE score in comparison to baseline. Moreover, cilostazol was shown     to be effective in preventing cognitive decline in patients with AD with cerebrovascular     diseases, mild cognitive impairment (MCI), and mild dementia who received donepezil.      These results highlight the need for a comprehensive prospective cohort study to analyze the     effect of cilostazol on the preservation of cognitive function in patients with early-stage     cognitive impairment, namely MCI.   "
60685|NCT02491255|"     The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve     System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR)     in symptomatic subjects with calcific, severe native aortic stenosis who are considered at     high or extreme risk for surgical valve replacement.   "
60686|NCT02491242|"     The objective of this study was to evaluate the efficacy and safety, and evolution of causes     leading to change, of dual therapies based in Dolutegravir in patients requiring a change of     virologically effective antiretroviral therapy.   "
60687|NCT02491229|"     The purpose of this study is to investigate whether a weight reduction with Hepafast in     combination with raw food and vegetables for two weeks followed by a meal substitution with     Hepafast and a calorie restriction in accordance with the Low Glycemic and Insulinemic Diet     (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver Disease     (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet without     use of Hepafast for 12 weeks.   "
60688|NCT02491216|"     Acupressure has been used for thousands of years in China. Through applying pressure on the     specific acupoints based on Traditional Chinese Medicine theory, acupressure could promote     relaxation and wellness, balance yin-yang and treat diseases.      The PI has been using acupressure to treat various diseases in the clinics of the School of     Chinese Medicine, The University of Hong Kong. Acupressure has demonstrated significant     efficacy in treating geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid     arthritis and various painful symptoms. When applying acupressure on the Head- Neck -     Shoulder area, it could also help to improve insomnia, reduce pain, and regulate the mood of     the patients.      Frailty is a geriatric syndrome of growing importance in the medical field. Prevalence of     frailty increases with age. As our life expectancy increase, there will be more elderly     suffered from frailty in the later stage of their life. Although there is still a lack of     universally accepted clinical definition for frailty, the syndrome is now commonly understood     as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty     could be initiated by single or multiple conditions including malnutrition, chronic diseases,     lack of exercise, stress and physiological or social changes caused by aging. Its     manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional neuroendocrine     system and a pro-inflammatory state. Frailty could affect the emotional state of the elderly,     meanwhile, positive affect is protective against the functional and physical decline     associated with frailty. There is limited treatment or medication for frailty. The     investigators believe that acupressure could be a possible non invasive means to improve the     general health conditions, including the emotional conditions of the frail elderly. In the     past 2 years, the school of Chinese Medicine has been promoting acupressure as a health     maintenance technique to the elderly, mostly frail elderly living in the community dwelling     through seminars. It is in investigator's interest to run a prospective research to further     understand the efficacy of acupressure in a wider range of frail elderly. The investigators     would like to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate     if acupressure could help the frail elderly to improve their general quality of life   "
60689|NCT02491203|"     Stroke is a leading cause of death and long-term disability worldwide and its incidence is on     the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a     significant long-term impact on activities of daily living, leisure activities and work. The     capacity for recovery following a stroke depends on several factors, including the extent of     the initial neurological damage, spontaneous recovery and rehabilitation, with possible     recovery even years after the stroke. Unfortunately, accessibility of much needed     rehabilitation services poststroke often remains limited, both in terms of intensity and     duration, as reported in a recent report on post-stroke rehabilitation services in Quebec     (Richard, 2013) Recent evidence suggests that homebased telerehabilitation (TR) is a viable     approach for upper limb training post-stroke when rehabilitation services are not available.     Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013     recommends home-based patient monitoring be used when frequent monitoring is needed and     face-to-face visits are not available. Hence, The investigators have developed and propose to     examine the use of a TR system that allows upper limb rehabilitation with ongoing off-line     monitoring, to be used after usual poststroke rehabilitation is completed and services are no     longer offered.   "
82181|NCT02210273|"     The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe     and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.   "
60690|NCT02491190|"     This project leverages digital health technology to support patient engagement and shared     decision-making between families, patients, and providers. The investigators will start by     finalizing the educational module and adding randomization for the trial (Aim 1). The     investigators will then complete iterative user testing in the live system through     measurement of educational module views and usability feedback interviews with 20 end users     (Aim 2). The investigators will then conduct a randomized controlled trial to test the impact     of the educational module on existing measures of patient engagement (Aim 3). The hypothesis     is that parents who receive the educational module will have higher scores on shared     decision-making, patient activation and overall patient experience.   "
60691|NCT02491177|"     This is a 2x2 factorial cluster randomized trial of two interventions to improve retention     and adherence for women and infants on Option B+. The overall goal is to determine which     intervention (or combination of interventions) maximizes antiretroviral therapy (ART)     adherence and retention in care in the context of Option B+ and thus improves maternal and     infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya     at 20 low-resource primary health care facilities and associated communities supported by     Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief     (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune     deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both     process and outcome indicators using a 2x2 factorial design, in which equal numbers of     clusters will be randomized to one of the interventions (community-based mentor mothers or     theory-based mobile text messages), both interventions, or standard of care. The     interventions will be added to fully integrated high quality HIV and antenatal, maternal,     neonatal, and child health (ANC/MNCH) services already offered at these sites.   "
60692|NCT02491164|"     Critically ill patients are often ventilated in dedicated critical care units to provide     respiratory support. Despite best practice patients can often develop a condition called     adult respiratory distress syndrome (ARDS), which is characterised by deterioration in their     respiratory function, and changes on chest x-ray. The correct management for ARDS is     identifying the underlying condition causing the deterioration and identifying appropriate     targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs     of a ventilated patient. The patients may have been ventilated due to pneumonia but they may     also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has     significant mortality.      Despite all the clinical and laboratory data at the investigators' disposal there remains     great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often     given empirically. Therefore, there is an urgent clinical need for accurate methods to     diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As     such, the investigating team have developed and synthesised an imaging agent called BAC TWO.     BAC TWO will be instilled directly into the lungs of 12 patients to assess whether it can     label gram-negative bacteria in the human lung.   "
60693|NCT02491151|"     Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed     inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing     and ineffective fluconazole trough serum concentrations were found in a recent retrospective     study. Variability in fluconazole exposure can be easily measured with therapeutic drug     monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug     monitoring can be valuable regards decreasing mortality.   "
60694|NCT02491138|"     This study evaluates the efficacy of appearance-based interventions in promoting healthy     sleep. One group of participants will receive standard information about sleep (control     group), while the other group will receive information about how sleep affects their physical     appearance (intervention group).   "
60695|NCT02491125|"     The study will investigate the effect of cereal based prebiotic fibres on intestinal health     and functioning and host metabolism.   "
60696|NCT02491099|"     Primary Objective: To assess the activity of Afatinib in patients with persistent or     recurrent uterine serous carcinoma overexpressing HER2/neu with the frequency of patients who     survive progression-free for at least 6 months after initiating therapy. Secondary     Objectives: To assess objective response rate and durable disease control rate. To assess     overall survival. To assess the safety profile of Afatinib in uterine serous carcinoma     patients.   "
60697|NCT02491086|"     Background About half of the daily smokers in Hong Kong have never tried and have no     intention to quit smoking. 37.9% of daily smokers attempted to quit but failed. Nicotine     replacement therapy (NRT) is a safe and effective pharmacotherapy to reduce withdrawal     symptoms during early stage of tobacco abstinence and increase quit rate. However, the     prevalence of using NRT in Hong Kong is lower than most of the developed countries. The     proposed project aims to test if providing free NRT sampling to smokers can increase quit     attempt and hence quit successfully.      Methods Nurses and university undergraduate students will be trained, and will invite smokers     at outdoor public places to participate in the randomized controlled trial, which randomized     eligible smokers to intervention or control group. The intervention group will be provided     with 1-week free NRT sampling and medication counselling, whereas the control group will only     be advised to purchase NRT on their own. The primary outcome is the proportion of any     self-reported quit attempt (no smoking for at least 24 hours) in the past month at 1- and     3-month telephone follow-up.      Discussions The findings will inform the feasibility and effectiveness of delivering free NRT     sampling to increase quit attempt and abstinence. It will yield more information on smokers'     adherence to the NRT sampling, side effect and safety issue of the usage. Moreover, it will     guide a future larger trial to test the effect from the NRT sampling and translation to     practice.   "
60698|NCT02491073|"     The purpose of this research study is to determine if the blood tests used to measure free     thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine if     eslicarbazepine acetate interferes with these blood tests, blood samples will be analysed so     that researchers can compare different types of lab tests that measure these thyroid     hormones. Half of the people who participate in this study will already be taking     eslicarbazepine acetate either as a study drug or as a prescription (Part 1) and the other     half will be people who do not take eslicarbazepine acetate (Part 2).   "
60699|NCT02491060|"     The primary objective of this study is to compare the efficacy, safety and tolerability of     IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.   "
60702|NCT02491021|"     Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic     effect on the human body and mind. Following discharge from an ICU, patients suffer from     varying degrees of weakness and muscle wasting. It can take many months before their strength     returns to something like before they were ill. This weakness can have important consequences     on an individual, affecting their ability to perform routine tasks (e.g. housework,     shopping), and whether they can return to work or not. Not surprisingly, this inability to     perform activities they used to do prior to their illness can have knock on effects on their     mental well being and confidence.      What the investigators hope to see through this study is whether or not patients can recover     their ability to perform exercise more quickly following an ICU admission if they undergo an     exercise-based rehabilitation programme. The investigators also hope to see whether taking     part in a rehabilitation programme has any affect on physical and mental well being.      The investigators hope to use a simple exercise test on a bicycle to assess subjects ability     to exercise shortly after leaving hospital. We will then repeat the test after a period of     physiotherapy lead rehabilitation to see if they have received any benefit from the     programme. The investigators hope to show that by undergoing an exercise-based rehabilitation     programme subjects will recover their ability to exercise more quickly than those who do not.      By means of questionnaires the investigators hope to see what effect the rehabilitation     programme has had on participants physical and mental well being.   "
60703|NCT02491008|"     Thyroid hormone is a key regulatory hormone for a range of physiological systems, including     the skeleton. Previous studies have suggested that subclinical thyroid dysfunction (SCTD) may     be associated with deleterious skeletal effects. However, controversy persists on the     clinical relevance of SCTD as well as on optimal thresholds for treatment. Available data     have substantial limitations: 1) limited prospective data are available to assess the     associations between SCTD and non-cardiovascular outcomes, such as fractures 2) lack of data     from large RCTs to investigate the pathophysiological mechanisms of associations between     thyroid hormone and bone loss. The aim of the study is to examine the relationship between     subclinical hypothyroidism and thyroid hormone replacement in regard to skeletal fragility,     bone mineral density (BMD), bone loss and metabolism, and the risk of fractures in elderly     participants. The listed parameters will be assessed by dual energy X ray absorptiometry     (DXA) and novel bone imaging techniques at baseline, at 1 year of follow-up. The study will     be nested in the TRUST trial (clinicaltrials.gov ID: NCT01660126), and will make use of its     study infrastructure to determine bone biomarkers from biospecimens at baseline, and at 1     year of follow-up from 145 Swiss participants with persistent subclinical hypothyroidism     randomized to either thyroxine or placebo in Bern and Lausanne.   "
60704|NCT02490995|"     The purpose of the study is to measure the interest of a movie explaining the path of the     children in surgery, in order to reduce the anxiety of the children and his parents.      This study is interventional, method randomized, controled, open-label, comparing two     parallel arms: anesthesist explanations versus anesthesist explanations + a movie     explanation.   "
60705|NCT02490982|"     The main goal of this investigator-initiated study is to evaluate the effectiveness and     efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS)     patients treated in regular practice, over a period of at least two years, in the regular     setting of a Multiple Sclerosis Clinic.   "
60706|NCT02490969|"     Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for     the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute     Coronary Syndrome (ACS) and a low-to intermediate risk profile.   "
60707|NCT02490956|"     The purpose of this study is to evaluate diagnostic immunization protocol of rabies vaccine     for diagnosis the patients with primary immunodeficiency disorders and study humoral and     cellular immune response to rabies vaccine in patients with primary immunodeficiency.   "
60708|NCT02490943|"     Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may cause     injection related erythema. This is a randomized controlled cross-over trial of superficial     hot and cold modalities to reduce injection site erythema caused by PEG.   "
60709|NCT02490930|"     A recent prospective multicenter study by Dr. Grossman demonstrated that 40% of patients with     high grade glioma undergoing radiation and chemotherapy developed severe and persistent     lymphopenia (CD4 counts <200 cells/mm3). This lymphopenia lasted for twelve months following     radiation treatment and on multivariate analysis was associated with shorter survival. Our     group has data that strongly suggests that this lymphopenia is secondary to the inadvertent     radiation of circulating lymphocytes as they pass through the radiation beam. Investigators     propose the use of FDA approved for multiple sclerosis, fingolimod to signal lymphocytes to     leave the circulation prior to the initiation of radiation. It is a functional antagonist of     the sphingosine-1-phosphate receptor (S1PR) pathway and prevents lymphocyte egress from     secondary lymphoid organs.      Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and     temozolomide and will be discontinued immediately upon completion of the six weeks of     therapy. The primary objective is to evaluate if fingolimod can be safely combined with     radiation and temozolomide. Secondary endpoint is total lymphocyte counts (TLC) for the     proposed study participants. Investigators expect that patients receiving radiation and     temozolomide plus fingolimod have a recovery of lymphocyte counts to 80% of baseline within     four months, reference to historical control in which sustained lymphopenia lasted for twelve     months.   "
60710|NCT02490917|"     The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment     of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on social     continence at 6 months.      Continence is defined by the average number of pads used per day. The social continence is     defined by (0-1) pad per day   "
60711|NCT02490904|"     Evaluate the impact of eplerenon (administrated during 4 days in immediate pre-operative and     post-operative period) on graft function evaluated by the measurement of glomerular     filtration rate at 3 months - variable strongly associated with long term graft survival.   "
60712|NCT02490891|"     The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before     and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass   "
60835|NCT02489279|"     The purpose of this study is to evaluate the effects of different types of cognitive training     on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using mobile     software on personal mobile devices.   "
60713|NCT02490878|"     This randomized phase II study aims to investigate whether the addition of bevacizumab to     standard corticosteroid therapy results in greater improvement in symptoms and less     treatment-induced symptoms compared with standard corticosteroid therapy for patients with     symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition     of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and     improve neurologic impairments in patients with brain radionecrosis following radiosurgery     for brain metastases.   "
60714|NCT02490865|"     The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the     circulation.   "
60715|NCT02490852|"     This is a growth study of full-term infants. The growth of infants fed the investigational     formula will be compared with infants fed a control formula. A breastfeeding arm will be used     as reference.   "
60716|NCT02490839|"     Up to now, there is few randomized, large scale study prospectively and simultaneously     comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy     (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori     eradication.      The aims of this study are:        1. to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;        2. to compare the patient adherence and adverse effects of these treatment regimens;        3. to investigate factors that may influence H. pylori eradication by these treatment          regimens.   "
60717|NCT02490826|"     The primary aim of this study is to develop software as a tool in speech and language therapy     for the treatment of children (Portuguese and English) with phonologically based Speech Sound     Disorders (SSD). Further, this project aims to test the effectiveness of this approach with     two groups of preschool and school aged children with phonologically based SSD, with one     group consisting of European Portuguese (EP) speakers and one group of British English (BE)     speakers. Performance across the two groups will be compared. The total duration of the     project will be 30 month.   "
60718|NCT02490813|"     Recently, there has been an increasing interest in using traditional Chinese medicine for     food allergy. The Harvard group has successfully demonstrated the Food Allergy Herbal Formula     - FAHF2 completely blocked peanut-induced anaphylaxis in a murine model, and currently being     studied in human. Therefore, in collaboration with the Institute of Chinese Medicine, CUHK,     the investigators have developed a more simplified Chinese herbal formula - X (CHFX),     containing four food-grade Chinese herbs, Wu-mei (Fructus Pruni Mume); Ling-zhi (Gonoderma);     Huang-bai (Cortex Phellodendron) and Zhi-su (Perilla frutescens).      In the present study, the investigators would like to examine whether there is reduction in     allergic symptoms in food challenge after administering the CHFX for 8 weeks. There will be     pre- and post- CHFX food challenges and other related tests.   "
60720|NCT02490787|"     This trial is conducted globally. The aim of this trial is to investigate safety,     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the     effect of the investigated drug on the body) of concizumab administered subcutaneously to     haemophilia A subjects.   "
60721|NCT02490774|"     Investigation of pharmacological effects, drug blood levels and safety of an intrauterine     system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy     young women treated for 90 days to determine the drug dose for further development   "
60722|NCT02490761|"     Unintentional weight loss and undernutrition are well described problems in elderly     inpatients, occurring in around 23% to 62% of hospitalised elderly in developed countries.     Not only are a large number of elderly patients undernourished at admission but a substantial     proportion will lose weight and become malnourished during their hospital stay, putting them     at increased risk of morbidity, mortality, poor clinical outcomes and prolonged length of     hospital stay. However, as it is frequently impossible to correct undernutrition prior to     hospital admission, every effort should be made to prevent weight loss and correct     undernutrition during hospitalization. Therefore, screening and identification of predictors     of patients at risk of weight loss and undernutrition at admission, and identification of     modifiable factors (e.g. eating preferences and poor food hospital intake), where     intervention might be helpful, are important aspects in the management of these patients.      Before designing a food intervention study, there is a need to, firstly:        1. describe hospital food intake, eating habits and preferences in elderly inpatients          during hospitalization        2. describe predictors of hospital food intake in elderly during hospitalisation        3. compare energy and protein intake in elderly inpatients during hospitalisation with the          United Kingdom Dietary Reference Values (DRVs)      This study is a hospital based observational study. Eligible participants will be 125     patients (aged ≥ 65 years old) admitted to the geriatric wards of 2 hospitals in the West of     Scotland. Eligible participants will be seen 96 hours after admission in order to explain the     study process and to obtain written consent. The researcher will record basic body size     measurements and will ask the patient questions about living conditions, feelings, memory,     health, eating habits, opinions about the hospital food service. Nursing staff will be asked     about patient's functional activity. The researcher will also take pictures of a subset of     patients' main meals (breakfast, lunch and dinner) on a single day, prior to and after     eating. The researcher will meet each patient three times in total. The first time 4 days     after admission; a second time, during the hospital stay and, finally, around the time of     discharge to repeat some measurements including weight, BMI, skinfold, mid upper arm     circumference, grip strength and calf circumference.   "
60723|NCT02490748|"     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with     cervical cancer.   "
60724|NCT02490735|"     Chemotherapy is the main treatment method for patients with Esophageal Cancer. However,     Relapse remains the major cause of treatment failure.Biological therapies such as CIK     stimulate the immune system and stop tumor cells from growing. A series of studies reported     that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators     suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy     may kill more tumor cells. In this study, the patients will be treated with CIK cells after     chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal     Cancer.   "
60725|NCT02490722|"     The aim of this study is to investigate effects of interdisciplinary group based patient     education in patients with low back pain.      The patients will be recruited to four group based patient education lessons during a two     months period. The study is a randomized controlled trial and the patients will be randomized     to standard treatment or standard treatment and patient education. The patient education will     be led by physiotherapists, nurses and physicians. The outcomes are functions, pain, quality     of life, self-efficacy, and depression. The data are reported in questionnaires.   "
60726|NCT02490709|"     The purpose of this study is evaluation of the safety and the efficacy of transanal local     excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after     neoadjuvant chemoradiotherapy.   "
60727|NCT02490696|"     The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in     patients with non-small cell lung cancer and correlate the results of PET scans with     immunohistochemistry.   "
60728|NCT02490683|"     This study will test the effect of both Luna Rich X© and Reliv Now© against placebo pills or     powder (control) on blood lipids. It will also explore the potential effects of these dietary     supplements on inflammation markers and other biological and anthropometric measures. The     study intervention will be 30 weeks in length. Twenty four subjects with 2 or more     cardiometabolic risk factors will be randomized to participate in the study.   "
60729|NCT02490670|"     The purpose of this study is to compare two different preparations of an antibiotic called     cephalexin to determine if they are essentially the same. The study has two periods.     Participants will receive one preparation of cephalexin in each period. At least 7 hours will     pass between the study periods. The study is expected to last about 2 days for each     participant, not including screening or follow-up.   "
60730|NCT02490657|"     The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation,     and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled     iloprost has been researched in animal study, but not yet in human during one-lung     ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic     obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air or     PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation. The primary outcome is     pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of     cardiac function including Tei-index during nebulizing iloprost. The investigators     hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic     obstructive pulmonary disease during one-lung ventilation.   "
60731|NCT02490644|"     One of the most important factor that affects the post op complication of the cardiac surgery     is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and     cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial     damage and inflammatory response. These myocardial damage and inflammatory response can cause     multi-organ failure or even death.   "
60758|NCT02490293|"     During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use     the postoperative antibiotics after surgery. However, there is no consensus regarding the     actual need of postoperative antibiotics in these cases and the use of postoperative     antibiotics remains controversial.      Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the     patients who has no evidence of systemic infection, according to the usage of postoperative     antibiotics or not. The investigators expect that the routine use of postoperative     antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have     no effects on the postoperative morbidity.   "
60732|NCT02490631|"     Surgical site infection (SSI) following spinal surgery is a frequent complication and results     in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a     frequent complication that has been reported to occur in 0.7-12.0% of patients and result in     higher postoperative morbidity, mortality and health care costs. Vanderbilt University     Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision     surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of     risk factors is thus important in the development of strategies to prevent these potentially     devastating infections. This study proposes a randomized, controlled trial of neuro-spine     patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op     surgical site infections in spine patients.      Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect     (decrease rates) of SSI compared to patients who receive routine standard of care (soap and     water pre-op, day of surgery and daily post-operative).   "
60733|NCT02490618|"     The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in     patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning.     Simultaneously the additional benefit of subgingival application of probiotics via oil drops     will be investigated.   "
60734|NCT02490605|"     The possible relationship between posture and instability of the masticatory muscles related     to occlusion thus becomes the reason, the objective of this study. In this way, it will be     possible to evaluate both postural alignment and postural balance in patients with signs and     symptoms of temporomandibular joint disorder before and after the use of an occlusal plate.     Our research will take place at the School of Odontology of the University of São Paulo in     the clinics of the Occlusion and TMJ Services (SOA) and of the Envelhecer Sorrindo program,     and the data will be collected in the Biophysics Laboratory of the School of Physical     Education and Sports of the University of São Paulo. The population studies will be made up     of 120 patients, 60 being part of the sample and the other 60 in the control group. All the     patients in this study are over 20 years of age and are of both genders; the research     criteria will be diagnosed by way of filling out the questionnaire of the RDC-TMD and     complemented by way of diagnostic imaging via MRI of the temporomandibular joint. The study     will be a clinical, randomized, controlled, prospective study and intervention. After the     subjects' alignment is evaluated by way of photographs and their postural balance by way of a     force platform, the group will the randomized; the sample group will receive an occlusal     plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence     of interference in the canine and anterior guides). The occlusal plate will be made from     Vacuum Form acetate with a thickness of 1.5 mm; the simultaneous, bilateral, occlusal     contacts and the canine and anterior guides will be obtained by way of autopolymerizable,     acrylic resin with the mandible in a centric relationship. The occlusal plate will be     controlled weekly. The control group will only receive orientation to do physiotherapeutic     exercises seeking to correctly position the mandible in the resting position (maxillar teeth     should be approximately 2 mm away from the mandibular teeth) while the tip of the tongue is     positioned and accommodated on the roof of the mouth over the incisive papilla on the hard     palate (without touching the teeth). The exercise will consist of repeatedly opening the     mouth with the tongue cleaving to the roof of the mouth, 3 times per day, each period     consisting of 3 sets with 15 repetitions. After 3 months, the two groups will be re-evaluated     in terms of postural alignment and balance.   "
60735|NCT02490592|"     Compare the remineralizing effect of acidulated fluoride gel Flugel (1.23% FFA, DFL) and     acidulated Fluoride Foam Flúor Care (1.23% FFA, FGM) in maxillary anterior permanent teeth of     58 children aged 7 to 12 years of age.      to verified the activity (visual scores) and the dimensional changes of whit spot lesions     (with WHO probe and millimeter ruler), risk for caries (CAMBRA) and OHI-S (Simplified Oral     Hygiene Index) of children.   "
60736|NCT02490579|"     The primary purpose of this study is to assess the responses of pregnant women and their     social network to six videos about health in pregnancy. Our goal is to assess a)     acceptability and b) understanding of core messages about healthy eating, exercise and weight     gain during pregnancy. We will also assess c) non-clinical sources of health information     during pregnancy.   "
60764|NCT02490215|"     The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients     admitted to intensive care units(ICUs). It represents a significant public health issue. No     large nationwide, multicenters study of ARDS has been conducted in China. The purposes of     this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated     the mortality ; and 3) risk factors for development of ARDS .   "
60737|NCT02490566|"     Using technology alongside a pediatric chronic disease specialist and behavior specialist,     the investigators are planning to help care for and coordinate the healthcare of children     with chronic diseases, particularly childhood obesity, diabetes and asthma in Miami's most     vulnerable communities. The University of (UM) Miller School of Medicine (MSOM) Pediatrics     and TeleHealth departments propose to leverage information and communications technologies     (ICT) in an innovative approach to improve the quality, access and efficiency of pediatric     services for children and their families.   "
60738|NCT02490553|"     The ELISABET STUDY is across sectional Survey on a representative sample of two urban area     conduct on a representative sample. The main objective of the project is to compare the     prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk     touched by the industrial pollution in relation to the one recovered in the Urban Community     of Lille (CUDL) less industrialized.   "
60739|NCT02490540|"     There is accumulating evidence that inappropriate analgesia is asssociated with increasing     risk of perioperative complications. The aim of the study is to compare intraoperative     analgesia guided according to different methods of intraoperative analgesia monitoring, ANI     and SPI respectively.   "
60740|NCT02490527|"     The purpose of this study is to gain insight into the side-effects of statin consumption, and     assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse     these changes. The investigators' prior research has shown that epicatechin can improve     skeletal muscle structure and mitochondrial (which gives us energy) structure.   "
60741|NCT02490514|"     This open-label, non-randomized, retrospective-prospective, non-interventional study will     evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney     disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12     months at a dose to be determined by the investigator.   "
60742|NCT02490501|"     This is an open, randomized, rehabilitation-controlled study in subjects with complete     Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation     of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants).   "
60743|NCT02490488|"     The objective is to evaluate the efficacy and safety of masitinib in combination with     gemcitabine in refractory ovarian cancer patients.   "
60744|NCT02490475|"     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of     rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that     have progressed during or after standard therapy, or for which no standard therapy is     available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in     escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).   "
60781|NCT02489994|"     Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of     Cellulite.   "
60782|NCT02489981|"     The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva®     Respimat®) in patients with severe persistent asthma under the real-world use was not     confirmed in clinical trials.   "
60745|NCT02490462|"     The Physical Therapy for children with Cerebral Palsy is of great complexity, in addition to     improving the neuromotor components at the level of structure and body function, must empower     them to carry out their activities and daily tasks and enable their social participation. In     this way, the goals of Physical Therapy are related to promote the independence and     functionality of the individual in situations of daily life. The participation of caregivers     in the rehabilitation process can contribute to potentiate the gains obtained by physical     therapy as well as to which they are incorporated into the day to day management of children     with cerebral palsy. Objective: To assess whether Physical Therapy associated with the     education of caregivers is effective in improving the functioning and quality of life of     children with cerebral palsy. Hypothesis: The combination of Physical therapy with the     education of caregivers improves in 15% the parameters analyzed against only 10% in those who     are only Physical Therapy. Methods: 60 children with cerebral palsy after acceptance and     signature in the term of informed consent will be randomly divided into 2 groups (G1:     Physiotherapy and education of caregivers and G2: only Physical Therapy) to do 3 sessions of     Physical Therapy and 1 weekly session of group education with duration of 45 min during 12     consecutive weeks. The evaluation will be carried out by means of the System of     Classification of Motor Function Gross (GMFCS), the evaluation of Motor Function through the     scale GMFM-88 (Gross Motor Function Measure - 88 ) and the Activity and Participation will be     evaluated by the Inventory of Evaluation of Pediatric Disability (PEDI). The analysis of the     results will be carried out using the Statistical Package for the Social Sciences (SPSS)     using descriptive statistics for social and demographic characteristics and inferential for     normality of data (test Kolmogorov-Smirnov ), mean comparison test to check for differences     between the groups and measures of association through the coefficient of correlation. The     level of significance of 5% will be established   "
60746|NCT02490449|"     This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after     breakfast in patients with nonerosive reflux disease.   "
60747|NCT02490436|"     The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than     placebo for the treatment of neuropathic pain.   "
60748|NCT02490423|"     This study will determine whether a complex, data-driven protocol for assessing patient needs     and providing nudges (reminders to be compliant with medication prescriptions) improves     compliance with cardiovascular medications. This will be accomplished by performing a     12-month clinical trial of patients with an indication for statin therapy. Participants will     be randomized to either an intervention or standard-of-care arm and will be followed via     passive electronic means to determine if they are compliant with medication prescriptions.   "
60749|NCT02490410|"     The purpose of this study is to compare the effects of different dose of whey protein     intervention(in a daily dose of 0g, 10g, 20g) on lean body mass,body fat composition and     muscular function state in the elderly with sacropenia.   "
60750|NCT02490397|"     The study tests if intense light could be a potential therapy in humans after myocardial     infarction by inducing Per2.   "
60751|NCT02490384|"     This is a multicenter randomized study designed to determine if physical exam indicated     cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women     with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks     of gestation.   "
60765|NCT02490202|"     Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in     patients who will be recipients of a donation after brain death (DBD) donor kidney.   "
60766|NCT02490189|"     To conduct a prospective, randomized trial to compare the efficacy of a group     mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive     behavior group therapy (CBGT).   "
62102|NCT02472717|"     Exploratory, double-blind randomized, placebo-controlled, Phase II study to evaluate the     effect(s) of short-term administration of liraglutide, a GLP-1R (glucagon-like peptide-1     receptor) agonist on joint and skin inflammation in patients with active Psoriatic Arthritis.   "
60752|NCT02490371|"     Stroke is the leading cause of function disability or impairment. Non-promising functional     return from upper limb rehabilitation has been reported. With the technology advances,     transcranial magnetic stimulation (TMS), which is a form of non-invasive direct brain     stimulation, may act as an attenuator in regulating or modulating the cortical excitability     in order to facilitate cortical re-organization and enhance behavioral performance. Various     therapeutic exercise protocols have been investigated regarding their efficacy in promoting     motor recovery of the affected upper limb for patients after stroke and the preliminary     results were supportive. However, limited numbers of randomized control clinical trials have     been published in investigating the priming or additive value of low frequency repetitive     TMS (rTMS) with combination of structural motor training programs.      Thus the objective of this study is: to determine the effectiveness of the combination of low     frequency rTMS on contra-lesional M1 and a structured upper limb motor training program on     restoring upper limb function among patients with stroke in sub-acute stage. It is     hypothesized that the rTMS, when combined with a structured motor training program, confers     additional therapeutic effects on upper limb motor function in subacute stroke patients, when     compared with the motor training program alone.      The objectives of this study is to determine the effectiveness of the combination of low     frequent rTMS on contra-lesional M1 and a structured upper limb motor training program in     restoring upper limb function among patients with subacute stroke.   "
60753|NCT02490358|"     This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers     to analyse biomarkers of inflammation   "
60754|NCT02490345|"     The specific aims of this research study are to use 600 mg gabapentin as an adjunctive     treatment for acute postoperative pain control in order to reduce postoperative opiate     consumption and improve postoperative pain control.   "
60755|NCT02490332|"     The prevalence of otitis media among Greenlandic children is one of the highest in the world     and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal     speech. Yet, there are no national guidelines to ensure prevention and treatment of recurrent     acute otitis media and chronic otitis media with effusion and impaired hearing in Greenlandic     children. International studies from the developed part of the world have shown that otitis     prone children may benefit from tubulation of the tympanic membrane. However, it is unknown     if these results can be applied to Greenlandic children.      This PhD project will conduct a randomised controlled trial comparing tubulation of the     tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis media     and/or chronic otitis media with effusion, to conservative treatment. The children will be     followed for two years. Outcome measures will include number of visits to health clinics,     number of tympanic membrane perforations, number of episodes with acute otitis media     according to medical records, Quality of life, measured by the validated questionnaires OM6     and Caregiver Impact Questionnaire, number of episodes where per oral or intravenous     antibiotics have been administered according to medical records and serious adverse events      The trial will be conducted in collaboration with the Greenlandic health authorities and     Copenhagen Trial Unit.      With this trial the investigators hope to decrease the number of episodes with acute otitis     media, the number of Greenlandic children with chronic perforations of the tympanic membrane     and hearing impairment and increase quality of life.      The results will add important knowledge to the effect of ventilation tube treatment also in     an international aspect. There are to date only less than a handful of high quality studies     concerning this issue on an international basis. The study will be among the first addressing     this problem among populations with high risk of otitis media and is also of interest to     other indigenous populations and the developing part of the world.   "
60756|NCT02490319|"     Radiation pneumonitis is the most common complication and the major dose-limiting toxicity     associated with radiotherapy, which can cause poor quality of life or life-threatening     symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently,     establishing reliable predictors for the occurrence of RP is of great significance such that     the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim     of this study is to figure out the biological prediction models of radiation pneumonitis.   "
60757|NCT02490306|"     This is a prospective, open, multicentre trial that will enrol patients with clinical signs     of stroke in the acute phase admitted for CT scan. Follow-up microwave measurements will be     performed after the acute phase. The study assesses the diagnostic capability and safety of     Strokefinder MD100.   "
60759|NCT02490280|"     The purpose of this study is to investigate how healthy youth and adults' cortisol levels and     other hormone levels relate to anxiety levels while they participate in a behavioral task     called the Trier Social Stress Task.      Data from these healthy participants will also be compared to those of anxious youth and     adults collected as part of the in the Principal Investigator's ongoing study titled,     Child/Adolescent Anxiety Multimodal Extended Long-term Study (NA00035687).   "
60760|NCT02490267|"     The management of childhood glaucoma (CG), childhood cataract (CC) and other birth defects     affecting the eyes requires frequent hospital attendances and often multiple surgical and     medical interventions, and are often associated with poor vision. Chronic medical conditions     and vision impairment can affect quality of life (QoL). The QoL of children with the above     conditions has not previously been evaluated.   "
60761|NCT02490254|"     The investigators wish to establish a robust estimate of the incidence of inflammation inside     the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to,     where they are referred to, which treatment they receive during the first year after     diagnosis, and how well they can see at the end of the first year.   "
60762|NCT02490241|"     Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation     to medication therapy for Major Depression, is commonly continued in pregnancy due to its     therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are     less than historically believed. Due to the increased elimination of lithium during     pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to     BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the     risk for postpartum exacerbation of BD and psychosis. Our study will investigate the     pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum. Twenty     women taking lithium in pregnancy or planning to become pregnant and continue lithium will be     invited to participate in a study to measure repeated blood levels of lithium at six time     points between preconception and 3 months postpartum. The data collected will inform the     dose, timing of dose, and frequency of dosing of lithium that will lead to fewer untoward     effects for the mother and baby. Change in elimination clearance of lithium will be     correlated with symptom worsening to develop a dosing algorithm that will help maintain     wellness for pregnant women with mood disorders.   "
60763|NCT02490228|"     To explore the minimally invasive and exhaustive treatment of female urethral canruncle by     using trans-artificial-urethral resection of the canruncle. The investigators plant to     recruit patients using this surgical method and study the effectivity of this method.   "
60768|NCT02490163|"     In a study performed in 2012, the investigators demonstrated that in ECP setting , the new     automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on     intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More     recently (in 2013), Terumo BCT released another automated system that allows to collect stem     cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over study     is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and     contamination) of MNCs collected from patients undergoing ECP with two different automated     systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection     procedure.   "
60769|NCT02490150|"     To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after     pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant     follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.   "
60770|NCT02490137|"     The purpose is to use MRI to investigate brain changes associated with playing a race car     video game for 90 minutes in aging adults both with and without early signs of dementia.   "
60771|NCT02490124|"     Arterial vascular disease is the major cause of morbidity and mortality for Type 1 diabetic     patients (DM1). Metabolic insulin resistance (metIR), even in the absence of hyperglycemia,     conveys a 1.5 to 3-fold increased CVD risk in the general population. Metabolic Insulin     Resistance (MetIR) has been repeatedly shown to be prevalent in adults and adolescents with     DM1. MetIR in obesity and DM2 are accompanied by vascular insulin resistance (vasIR) which is     characterized by impaired vasodilatory action of insulin on resistance or microvascular     vessels. VasIR has not been systematically studied in DM1. We hypothesize that in young     adults DM1 impairs both baseline and insulin-responsive vascular function throughout the     arterial vasculature.   "
60772|NCT02490111|"     This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone     formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants     will receive DWJ1319, while the other will receive a placebo.   "
60805|NCT02489682|"     This study evaluates the effectiveness of a patient-centered short written informed consent     form and a patient-centered short video informed consent in a randomized controlled trial     (control = traditional informed consent ). Primary outcome measures include critical     knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical     clinical trial. The investigators hypothesized that the patient-centered patient-designed     consent forms (video and written format) would do as well as or outperform the traditional     consent form on the primary outcomes.   "
60773|NCT02490098|"     Current intensive insulin therapy in T1D involves prandial insulin boluses depending on the     carbohydrate content of each ingested meal. Carbohydrate content of ingested meals is the     main determinant of post-meal glucose excursion. Therefore, accurate carbohydrate counting is     a critical aspect of managing postprandial blood glucose levels in type 1 diabetes in order     to avoid too much or too little insulin resulting in hypoglycemia and hyperglycemia,     respectively. Precision of carbohydrate counting is associated with better glycemic control.     However, accurate carbohydrate counting is a challenging task for many patients with type 1     diabetes. Recent developments of continuous glucose sensors and insulin infusion pumps have     motivated the research toward closed-loop'' strategies to regulate glucose levels in     patients with type 1 diabetes. In a closed-loop strategy, the pump insulin infusion rate is     altered based on a computer generated recommendation that rely on continuous glucose sensor     readings. A dual-hormone closed-loop strategy has also been recently proposed to regulate     glucose levels. In a dual-hormone strategy, subcutaneous insulin delivery is accompanied by     subcutaneous glucagon infusion. Postprandial meal glucose control with closed-loop strategy     still needs some improvements. The objective of this study is to test in outpatient     unrestricted settings whether, in the context of closed-loop strategy, conventional meal     carbohydrate counting could be reduced to a simplified qualitative meal size estimation     without a significant degradation in overall glycemic control in children and adult patients     with type 1 diabetes. The investigators hypothesize that 1) dual-hormone closed-loop strategy     with qualitative meal size estimation is equivalent to dual-hormone closed-loop strategy with     CHO counting in terms of mean glucose; 2) single-hormone closed-loop strategy with     qualitative meal size estimation is equivalent to single-hormone closed-loop strategy with     CHO counting in terms of mean glucose;   "
60774|NCT02490085|"     The introduction of insulin pump therapy in patients with type 2 diabetes using multiple     daily injections and poorly controlled can be considered in order to improve glycemic     control. Recent developments of continuous glucose sensors and insulin infusion pumps have     motivated the research toward closed-loop'' strategies to regulate glucose levels for     patients with diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based     on a computer generated recommendation that rely on continuous glucose sensor readings. This     study confirmed the feasibility and potential of the closed-loop strategy to improve glycemic     control while reducing the risk of hypoglycemia in patients with type 2 diabetes but did not     target the population most likely to benefit from this strategy.The objective ot this study     is to compare the efficacy of closed-loop strategy to multiple daily injections in regulating     glucose levels for 24 hours in elderly adults with type 2 diabetes under intensive insulin     therapy. The investigators hypothesize that closed-loop strategy will increase the time spent     in the target range in adults with type 2 diabetes compared to multiple daily injections.   "
60775|NCT02490072|"     Dexmedetomidine is a selective α2 adrenergic agonist that can be considered a primary     anesthetic, an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its     cardiovascular effect through activation of receptors in central and peripheral nervous     system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial     shorten-increase in blood pressure followed by long-lasting decrease in BP and HR. There were     several reports about these hemodynamic changs of dexmedetomidine, but not the evaluation of     direct cardiac function of patients who was preexisted diastolic dysfunction. The purpose of     this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant in     diastolic dysfunction by using the echocardiography.   "
60776|NCT02490059|"     The evaluation of solitary pulmonary nodules (SPN) requires a balance between     procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is     endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective     randomised trial we compared diagnostic yield and adverse events of UB with standard-size     bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.   "
60777|NCT02490046|"     This is a study to explore the feasibility of using D-mannose, a commonly used food     supplement, in persons with multiple sclerosis reporting recurrent urinary tract infections.     Twenty persons with multiple sclerosis (10 patients using catheters and 10 not using     catheters) reporting recurrent urinary tract infections will receive D-mannose 1.5 grams     twice daily for 16 weeks duration.      This will be explored through:        1. Assessing compliance to a 16-week course of D-mannose        2. Quantifying the number of prescriptions for antibiotics during the 16 weeks course of          D-mannose   "
60778|NCT02490033|"     Catheter ablation is now routinely used in the management of heart rhythm disorders. One of     the problems with the approach is that it has not been possible to determine whether the     ablation catheter is in direct contact with the heart tissue or not. This is important     because too much contact has safety implications and too little means that the therapy will     be ineffective. Recently two different technologies have been developed to determine contact.     Currently it is not know if one is superior to the other, and the objective of this trial is     to determine whether there is a difference when treating a rhythm called atrial flutter.   "
60779|NCT02490020|"     Although donation after cardiac death(DCD) is the major source of renal transplantation in     China, high incidence rate of rejection and delayed graft function(DGF) is existing due to     the prolonged ischemia time. According to the previous single center study, mesenchymal stem     cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there     was no perspective multicenter controlled study to confirm it. This perspective multicenter     controlled study will focus on clarifying the key role of MSC applied via renal arterial or     peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The     investigators have established GMP workshop and solid research foundation of transplant     rejection. This study will provide a new reasonable way for immune induction of renal     transplantation by DCD.   "
60780|NCT02490007|"     Aim To assess the possible food allergy-preventive benefit of using whole cell pertussis(wP)     vaccination compared with acelluar pertussis vaccine(aP) for whooping cough vaccination in     childhood.      Background Whooping cough, caused by the bacteria, Bordetella pertussis, represents a     significant public health burden in Australia and around the world. Acellular pertussis     vaccination (aP) replaced whole cell vaccination against pertussis (wP) in the late 1990s.     This replacement coincides temporally in an observed rapid rise in the occurrence of severe     food allergy responses. Previous research has suggested that acellular pertussis vaccination     results in the development of immunity that may predispose children to allergic responses. A     retrospective case-controlled trial design, targeting cases of previously diagnosed allergy,     and comparing case vaccination history to that of the whole population, is a powerful means     of assessing the association between immunisation and allergy.      Participant Groups 1000 allergy cases, 10,000 controls      Project Design This is a retrospective individually-matched case-control study of Australian     children born during the period of transition from use of wP vaccines to aP vaccines (year of     birth 1997-1999 inclusive) and who are registered on the Australian Children Immunisation     Register. Cases will be drawn from allergy clinics associated with tertiary teaching     hospitals around Australia.      Methods Cases: will be retrospectively identified from patient lists from allergy clinics     around Australia, born during the period of pertussis vaccine changeover, and be confirmed to     have IgE-mediated food allergy on the basis of 1) a documented history of consistent clinical     symptoms following ingestion of an implicated food, and 2) evidence of sensitisation to that     food via laboratory testing.      Controls: Controls will be sampled from a de-identified database of children born during the     transition from wP to aP vaccination appearing on the ACIR. Cases and controls will be     matched by date of birth (+/-7 days), jurisdiction and socioeconomic decile.      Expected outcomes: Following the study, investigators will be able determine if there is an     association between the type of vaccination received and development of IgE mediated food     allergy. If whole cell vaccination is found to have a protective association against the     development of allergy, this will have profound impact on health policy in Australia and     around the world.   "
60783|NCT02489968|"     Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will     evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg +     linagliptin. All analyses will be carried out separately for these study parts. The objective     of Part A is to investigate the efficacy, safety and tolerability of the fixed dose     combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg     plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients     with T2DM who have insufficient glycaemic control after 16 weeks of treatment with     empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC of     empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo     after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety     and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with     empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in     Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of     treatment with empagliflozin 25 mg alone once daily. The study is designed to show     superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg     plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be     followed by a 28 week extension treatment period to evaluate further efficacy and safety up     to 52 weeks.   "
60784|NCT02489955|"     Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the     long term damage to their lungs from infection. This would typically be with a two week     course of intravenous antibiotics each time they have a chest infection (typically three to     four times a year).      The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot     be used because of previous side effects, allergy or a resistant infection then colomycin or     amikacin are usually used. Each of these antibiotics are known to be toxic to both the     kidneys and ear. As patients are living longer (into their forties), the total amount of     these antibiotics they are receiving over their lifetime is increasing. This is now leading     to increased complications such as kidney damage and hearing loss. Because of this, the     investigators need to look at methods to accurately quantify damage and reduce potential     kidney and hearing damage.      The investigators intend to quantify kidney damage by measuring new protein markers within     the urine and blood that signify kidney damage before more conventional and currently     available methods are able to.In those patients treated with intravenous tobramycin the     investigators will also look at an alternative method used to calculate the most appropriate     dose of antibiotic for each participant. This dosing method is called 'area under the curve     or AUC' dose monitoring. This method currently in clinical use in other countries is thought     to more accurately reflect the most appropriate dose for each participant and thus reduce the     chance of kidney and hearing problems. This 'AUC' method requires two rather than one dose     level to be checked each time a dose calculation is made. Participants receiving tobramycin     will be randomised to receive dosing by this method or the investigators' currently used     method of 'trough' monitoring.   "
60785|NCT02489942|"     Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in     Japanese patients with type 2 diabetes mellitus   "
60786|NCT02489929|"     Myelodysplastic syndrome (MDS) is a group of medical conditions derived from progressive bone     marrow failure that result in ineffective production of blood cells. Depending on the     severity, MDS reduces the quality of life to the point of being life-threatening. There is a     probability of death at all stages of the disease, due to complications and co-morbidities,     with progression to acute myeloid leukemia (AML) being the worst evolution. Azacytidine is a     nucleosidic analog with original epigenetic mechanism of action that is widely used for     treating a variety of myelodysplasic syndromes. Although generally well tolerated, severe and     sometimes life-threatening toxicities were unexpectedly observed in some patients. Genetic     polymorphism affecting cytidine deaminase (CDA), the liver enzyme responsible for azacytidine     detoxification step, could be responsible for poor clinical outcome due to on the one hand to     severe toxicities in deficient patients, and on the other hand on treatment failure in     ultrametabolizer patients.This clinical study aims at correlating the values in CDA levels     with the risk of drug-related toxicities and to the clinical response to azacytidine     treatment.   "
82220|NCT02209766|"     The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884     following administration of single and multiple doses in healthy male Japanese subjects.   "
60788|NCT02489903|"     The study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize     small cell and non-small cell lung cancer, ovarian cancer and high grade neuroendocrine tumor     patients who previously responded and now have failed a platinum based doublet to the     previously effective therapy.   "
60789|NCT02489890|"     Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse     remains the major cause of treatment failure.Biological therapies such as CIK stimulate the     immune system and stop tumor cells from growing. A series of studies reported that     cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators     suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy     may kill more tumor cells. In this study, the patients will be treated with CIK cells after     chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder     Cancer.   "
60790|NCT02489877|"     Multiple sclerosis is the most common autoimmune inflammatory disease of the central nervous     system. It is known that your etiology has genetic and environmental causes. Several viruses     have been implicated as triggers as well as perpetrators of this disease. Several studies     make the correlation between Endogenous Retrovirus Type W (HERV-W) and the family     Herpesviridae and activity in the pathogenesis of multiple sclerosis. The most important     characteristics of the virus implicated in the pathogenesis of the disease is the fact that     they have latency periods of exacerbation and they have, as their main biological     environment, the central nervous system. The HERV-W, Epstein-Barr virus (EBV),     cytomegalovirus, herpes virus type 6 and type 7 herpesvirus members are the most studied as     causes of multiple sclerosis. It was found that these viruses are closely involved in the     pathogenesis of MS, but it is believed that aren't the only responsible for its beginning. It     is likely that this disease presents numerous triggers and more studies are needed to     determine these interactions. In addition, a study comparing the activity of multiple     sclerosis with the presence of these viruses was never realized.   "
60862|NCT02488928|"     EBUS elastography is a method to determine stiffness of lymph nodes, based on the minute     deformation of the node by the beating heart. Whether EBUS elastography may further increase     the sensitivity to predict the presence or absence of malignancy is unclear.      We suggest to use EBUS elastography strain pattern analysis for this assessment and correlate     these measurements with the final pathology outcome to determine NPV, PPV, sensitivity and     specificity of this analysis to predict the presence or absence of malignancy in patients     with (suspected) lung cancer in a prospectively obtained observational cohort study.   "
60791|NCT02489864|"     Appreciation of the central role for arterial vasodilatation in the pathogenesis of     hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with     albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal     approach for such therapies has not yet been established. As compared with albumin, treatment     with terlipressin and albumin is effective in improving renal function in patients with     cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial pressure     (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with ascites.     The purpose of this study was to examine the role of targeting an early and substantial     increase in mean arterial pressure in the prevention of type 2 HRS.   "
60792|NCT02489851|"     The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage     of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local     anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread     of the local anesthetic agents may produce extensive analgesia and prolonged action of the     injected local anesthetic solution.      Previous studies showed that both TAP block and QLB may reduce morphine requirements in the     postoperative period in patients who had cesarean section under spinal anaesthesia. However     there are no published reports comparing the 2 techniques.      The aim of this randomised controlled, double blinded study is to compare the analgesic     efficacy of QLB compared to TAP block in patients who had cesarean section under spinal     anesthesia.   "
60793|NCT02489838|"     To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for     Liver Cancer.   "
60794|NCT02489825|"     Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized     controlled trials (RCTs) with substantial methodological problems have led to an intense     discussion another RCT with larger case numbers, more representative inclusion criteria and a     more consistent and sound methodology has revealed results that mirror the investigators' own     clinical experience. In their daily practice, the investigators have further advanced their     treatment concept and routinely apply prophylactic augmentations with VP using an algorithm.     Biomechanical studies support their approach, but clinical studies are rare so far.     Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a     small pilot study. Given the above mentioned methodological and clinical disputes and the     call for high-evidence studies about VP, the investigators aim at generating a reliable     sample size calculation and preliminary results for a future multicenter RCT about     prophylactic adjacent level augmentation with VP in single level osteoporotic compression     fractures.   "
60795|NCT02489812|"     Music plays an important role reassuring helping reduce anxiety. Anxiety can be an     interference factor in promoting oral health for children with high levels of anxiety tend to     have negative behavior at the dentist. High oxygen levels and heart and respiratory     frequencies are associated with high levels of anxiety. The objective of this study was to     test the use of music in decreased cardiac and respiratory frequency of treated patients     listening to music and being treated without hearing music.   "
60796|NCT02489799|"     Through close engagement with our patient and family member co-investigators, the     investigators have developed a video-based advance care planning aid for cancer patients and     their family members who are preparing for major surgery. In this study, patients are     randomized to see either the intervention video (involving advance care planning-related     content) or a control video (no advance care planning-related content) prior to surgery. The     investigators hypothesize that the video will lead to more and better preoperative     discussions between the patient and surgeon that are related to advance care planning. The     investigators also hypothesize that seeing the advance care planning-related video will     decrease perioperative anxiety and depression scores.   "
82204|NCT02209974|"     Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic     inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is     controversial.   "
60797|NCT02489786|"     Digoxin is the primary cardiac glycoside in clinical use. Because of the narrow therapeutic     index and risk of toxicity, therapeutic drug monitoring is highly recommended. In Egypt, most     cardiologists give digoxin holiday for both atrial fibrillation and heart failure, it is not     clear if the interrupted digoxin regimens are effective since serum digoxin concentrations     might fall below the therapeutic range.      Objective: To evaluate and compare the digoxin serum concentration and patient's quality of     life in the continuous versus interrupted digoxin dosing regimens.   "
60798|NCT02489773|"     To confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding     2-3 weeks) monitoring of glycemic control in patients with diabetes.   "
60799|NCT02489760|"     To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS     patients.   "
60800|NCT02489747|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of water extract from wheat Triticum aestivum L on     cognitive and memory function. The investigators measured changes in cognitive function     parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF   "
60801|NCT02489734|"     The purpose of this study is to determine whether the incidence of emergence delirium will be     reduced when end-tidal concentration of sevoflurane decreases.   "
60802|NCT02489721|"     Most important peripherally inserted central catheter (PICC) and Midline complications are     thrombosis and catheter related blood stream infections. No large prospective observational     study are present in literature about these topics. The aim of this multicenter prospective     observational study is to analyze all the complications due to PICC and Midline insertion.   "
60803|NCT02489708|"     This two phase study will develop and evaluate a Pediatric Emergency Department (PED)     Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the     identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure     intervention to caregivers who bring their child to the PED.   "
60804|NCT02489695|"     Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients     with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line     treatment.   "
60863|NCT02488915|"     The study objective is to examine the recanalization efficacy of the EmboTrap device and its     associated performance characteristics and to record associated clinical outcomes in a manner     that facilitates relevant comparison of outputs with that of devices approved in the U.S. for     clearing Large Vessel Occlusions.   "
60806|NCT02489669|"     The urine flow rate (UFR)-guided and the left-ventricular end-diastolic pressure     (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney     injury (CI-AKI). The REnal Insufficiency Following Contrast MEDIA Administration TriaL III     (REMEDIAL III) trial is a randomized, multicenter, investigator-sponsored trial aiming to     compare these 2 hydration strategies in high risk patients.      Patients with estimated glomerular filtration rate <45 ml/min/1.73 m2 and/or a high risk for     CI-AKI (as defined according to both Mehran's score ≥11 and/or Gurm's score >7) will be     enrolled. Patients will be divided in high (>12 mm Hg) and normal LVEDP, non-invasively     estimated by transmitral flow velocity to annular velocity ratio (E/E' index). Patients in     each group will be randomly assigned to 1) LVEDP-guided hydration with normal saline     (LVEDP-guided group). The fluid infusion rate will be adjusted according to the LVEDP as     follows: 5 mL/kg/hr for LVEDP <12 mmHg; 3 mL/kg/hr for 13-18 mmHg; and 1.5 mL/kg/hr for >18     mmHg. 2) UFR-rate guided hydration (RenalGuard group). In this group, hydration with normal     saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach     and maintain a high (>300 mL/h) UFR. In all cases iobitridol (an low-osmolar, non ionic     contrast agent) will be administered. The primary endpoint is the composite of CI-AKI (i.e.,     serum creatinine increase ≥ 25% and ≥ 0.5 mg/dl from the baseline value at 48 hours after     contrast media exposure) and/or acute pulmonary edema.   "
60807|NCT02489656|"     This study is a prospective, randomized multicenter study conducted in Europe. It is designed     to compare two double loop ureteral stents in terms of the quality of life in patients     operated on a kidney stone and requiring the placement of a double loop ureteral stent at the     end of the operation.   "
60808|NCT02489643|"     The aim of the study will be to evaluate the impact of this individualized practical training     on efficacy (evaluated by Psoriasis Area and Severity Index (PASI) and Body Surface Area     (BSA) score performed by a physician blinded to the study groups) and adherence (calculated     as days wherein gel was applied and as BSA/weight of gel applied rate) to a 4 week long     treatment with dovobet gel. On the other hand, the investigators will evaluate in both groups     as demographic (as sex, age, job,..) or disease (as severity, duration, impact of quality of     life,..) characteristics influence the adherence to the treatment.   "
60809|NCT02489630|"     This study investigates the use of low doses of ketamine, along with opiate pain medication,     is more effective at controlling the acute pain of patients in the emergency department than     opiate pain medication alone. In addition, this study examines whether patients treated with     low doses of ketamine, along with opiate pain medication, will require less opiate pain     medication to control their pain, and whether these patients are equally happy with their     pain control as patients who receive only opiate pain medication.   "
60810|NCT02489617|"     This research study is studying a surgical intervention to rule out the presence of cancer in     participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal     papilloma without atypia (IPWA) by core needle biopsy.   "
60811|NCT02489604|"     This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic     Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative     will be enrolled in the study and will be randomly assigned to 2 different dosages (total     activity of 25.9 GBq and total activity of 18.5 GBq).   "
60848|NCT02489110|"     Photozig and Stanford University are creating a new program for Hispanic dementia caregivers     to help cope with caregiving, alleviate related stress, and enhance quality of life for     caregivers, with funding from the National Institute on Aging. The program includes a new     education online telenovela (Webnovela), online resources, handouts and a DVD (for users     without Internet) on how to deal with caregiving stress and handle difficult situations.   "
82205|NCT02209961|"     A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and     glaucoma surgery.   "
60812|NCT02489591|"     Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal     structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific     therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral     appliance (OA) therapy is increasingly being indicated for OSA treatment, although a complete     response occurs in approximately 50% of patients. In general, OA devices are designed to     maintain the mandible and/or tongue in a protruded posture during sleep, preventing upper     airway obstruction. Limited studies in awake or sedated patients have demonstrated the     effects of mandibular advancement on aspects of pharyngeal structure and function. The     objective of the proposed research is to fully characterize upper airway collapse in OSA     patients during natural sleep and use this information to understand why some patients appear     to exhibit a large improvement in pharyngeal collapsibility whereas others do not.   "
60813|NCT02489578|"     The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP     and healthcare-associated pneumonia (HCAP) in real life of China .   "
60814|NCT02489565|"     The purpose of this study is to determine whether the telemedicine use in primary health care     is effective in the accompaniment of stable coronary artery disease patients who were     discharged from the tertiary health care clinics.   "
60815|NCT02489539|"     The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER®     Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal     aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by     separate performance goals.   "
60816|NCT02489526|"     The purpose of this Phase 2 study is to evaluate the efficacy and safety of an analgesic drug     candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,     placebo-controlled study.   "
60817|NCT02489513|"     The study is designed to characterize the absorption, metabolism, and excretion of AG-120     using radiolabeled drug in healthy adult male subjects to support its further development and     registration.   "
60818|NCT02489500|"     Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant.      This study will compare the safety and effectiveness of standard treatment with high-dose     melphalan and stem cell transplant, compared with investigational bortezomib when used in     combination with standard treatment with high-dose melphalan and stem cell transplant for AL     amyloidosis.   "
60819|NCT02489487|"     A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500     given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel     design is used due to the long half life for VM-1500.   "
60820|NCT02489474|"     Some of the liver transplantation recipients experience postoperative acute kidney injury due     to various causes including genetic factors. Prevention of postoperative acute kidney injury     is essential for postoperative care in liver transplantation recipients. The aim of this     study is to investigate the relationship between gene polymorphisms which have been known to     be associated with postoperative acute kidney injury, and the occurrence of acute kidney     injury after liver transplantation.   "
60821|NCT02489461|"     To evaluate the following safety and efficacy parameters for VM-1500:        -  Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 12 (Stage I)        -  Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 24 (Stage II)        -  Decrease in viral load during 48 weeks of treatment        -  Percentage of subjects with at least 10-fold (1 log10) decrease in viral load at Week 4        -  Percentage of subjects with decrease in viral load to <400 copies/ml at Week 12        -  Percentage of subjects who continued to receive the investigational treatment up to Week          48        -  СD4+ and СD8+ cell count change during 48 weeks of the study        -  Percentage of subject who developed HIV-1 resistance to the investigational treatment by          week 48        -  Frequency of adverse events (AE) of different severity according to subjective          complaints, physical assessment, vital signs, laboratory tests, ECG        -  Frequency of adverse events of special interest, including of central nervous system          (CNS) effects        -  VM-1500 pharmacokinetic profile in selected subjects   "
60822|NCT02489448|"     The purpose of the study is to address the following hypotheses: (i) Anti-PD-L1 therapy with     MEDI4736 administered concomitantly with weekly nab-paclitaxel followed by MEDI4736     concomitant with ddAC neoadjuvant chemotherapy will induce higher pathologic complete     response (pCR) rate (>55%) in triple negative breast cancer than historical pCR rates     (30-40%) observed with chemotherapy alone. (ii) MEDI4736 can be safely co-administered at     full dose with sequential with nab-paclitaxel (100mg/m2) and ddAC (60 mg/m2 and 600 mg/m2     respectively).   "
60823|NCT02489435|"     The purpose of the study to assess safety and tolerability of VM-1500 and to determine main     pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy     subjects.   "
60824|NCT02489422|"     This randomized pilot trial studies how well two supportive programs work for improving     fatigue and depressive symptoms in patients with stage II-IV colorectal cancer undergoing     chemotherapy. Possible mediators such as psychological stress, circadian disruption, and     inflammation, will also be explored.   "
60825|NCT02489409|"     Endostatin has been widely applied for the clinical treatment of partial primary and     metastatic solid tumors. Endostatin combined with chemotherapy has achieved favorable     progression in the treatment of non-small cell lung cancer (NSCLC). However, the research     about the efficacy of Endostatin on breast cancer has just started. Breast cancer is a     highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin     therapy. Additionally, after chemo- and radiotherapy, the primary nidi of patients with     advanced breast cancer may also lead to rapid development of tumors in other locations. So     Endostatin combined with chemotherapy can also improve the prognosis of patients with     recurrent metastatic breast cancer, but there is rare any report at home and abroad. To     further explore the above research, this study designed a randomized, opened and controlled     clinical study to observe the clinical efficacy of EndostarTM Injection combined with     GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.   "
60900|NCT02488421|"     The purpose of this study is to determine and compare the persistence rate of newly     prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.   "
83039|NCT02199080|"     The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of     intraatrial thrombus before performing an ablation of atrial fibrillation   "
60826|NCT02489396|"     Rationale: Online-grocery shopping is predicted to be one of the hottest food trends of     2014, as national retailers such as Amazon, as well as start-up companies, venture into the     e- commerce grocery sector. Importantly, the online-grocery environment could be uniquely     manipulated to promote healthier food purchasing and help with weight control. Since     consumers tend to choose items listed first on menus and buffet lines, the order of food     products displayed on the grocer's website may impact purchasing. Furthermore, it's possible     that in an online-grocery environment, nutrition information could be made more salient to     consumers. For example, previous research has demonstrated that label color influences     perceptions of the healthfulness of foods. The FDA also recently proposed a redesign of     foods' nutrition facts panels, which would highlight calorie content in a larger font.     Although implementing this label change on all food labels could take years, e-commerce sites     could change the format of the nutritional information they display much more quickly.      Objectives: The proposed study intends to nudge consumers to make healthier grocery purchases     through three distinct interventions: 1.) Manipulating the order of food items within grocery     categories; 2.) Displaying product nutrition information in red or green; and 3.) Presenting     calorie information in a larger font size. We propose to examine these concepts in adult     consumers using a grocery e-commerce platform servicing socioeconomically and racially     diverse communities in the northeastern U.S.   "
60827|NCT02489383|"     The treatment of asthma is based in clinical control. However, previous studies have been     shown that patients that participate of the programs of regular or aerobic continuous     exercise training (CT) presented improvements in the physical conditioning, and quality life,     as well as decreased the levels of anxiety and depression, reduced the oxide nitric exhaled     and leukocyte migration at the airways and reduced the airway hyperresponsiveness. The     regular exercise also is important part in the rehabilitation of other lung disease as well     as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been shown     the effects of high intensity interval training (IT) in the pulmonary rehabilitation of COPD     patients, that after performed IT presented reduction of dyspnea, and increase the physical     capacity. In this sense, the impact of IT in the asthmatic patients at the present moment is     poorly studied, and necessity of the more investigation to prove the efficiency of this     training model for asthma patients.   "
60842|NCT02489188|"     To date, detailed analysis of movement patterns in orthopaedic conditions are mainly     performed in research projects. Because these tests are time consuming, they are not feasible     in clinical routine or in standard examinations. Novel technologies allow capturing detailed     movement patters within a few minutes. The aim of this regional study is to compare aspects     of movement tasks measured using a mobile gait analysis system to those measured using     laboratory based systems and to determine aspects of gait patterns relevant for different     orthopaedic conditions. Moreover, the researchers will investigate if these relevant aspects     can be altered using surgical treatment or manual therapy.   "
60864|NCT02488902|"     This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a     range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as     chemosuppression of P. falciparum malaria. Medications and placebo were matched and a     double-dummy technique enabled blinding of tafenoquine versus mefloquine.   "
60865|NCT02488889|"     This laboratory study will examine if varenicline can reduce alcohol-induced smoking lapse in     heavy drinking smokers.   "
60828|NCT02489370|"     Providing patients with chronic heart failure (CHF) access to remote monitoring, for example     by telephone or telemonitoring using wireless technology, reduces deaths and hospitalisations     and may provide benefits on health care costs and quality of life. Remote monitoring of     patients with chronic heart failure can reduce pressure on resources, particularly for     conditions like chronic heart failure, which exert a large burden on health services. These     are conclusions of the Cochrane Systematic Review from 2010.      In Norway the costs for treatment of chronic heart failure are vast, both concerning hospital     treatment, daily use of medication over years, and loss of quality of life for patients and     their family caregivers. Generally there is little knowledge about what is gained for the     billions used. In Norway no telemonitoring services are established and hence no     investigations have yet been published. Thus it seems that current evidence of effectiveness     and quality is insufficient to recommend usage. The structure and funding streams in     Norwegian health services are different from other countries and the conventional services     that the intervention has been compared to in previous studies, are most likely     heterogeneous. It is thus important to investigate Norwegian conditions.      Advanced telemonitoring technology with electronic transfer of physiological data such as     blood pressure and weight is currently being used in research and established routine     services in several countries in Europe, amongst them the Netherlands, Germany and the United     Kingdom.      The proposed project intends to introduce such a strategy as an avenue for exploring     promising new services that would not otherwise be available in Norway. The service consists     of daily monitoring the patients' weight and blood pressure directly from their home;     automatically and securely transmit the values to a server at the University Hospital of     North Norway (UNN); and monitor the values by a trained nurse at the Heart polyclinic.      The primary objective of this study is thus to explore whether, as compared to current care     from the Heart Polyclinic, the introduction of home telemonitoring will reduce hospital     readmissions and will, in addition, be cost-effective. This is in line with current     directions of European telemonitoring programmes for patients with chronic heart failure.     This result may define if the telemonitoring of heart failure patients is feasible for Norway     or not at all.   "
60829|NCT02489357|"     This pilot phase II trial studies the side effects and how well pembrolizumab and cryosurgery     work with short term androgen ablation to treat patients with prostate cancer that has     traveled from the original tumor, through the body, and formed a small number of new tumors     in other parts of the body (oligo-metastatic). Cryosurgery, also known as cryoablation or     cryotherapy, kills tumor cells by freezing them. The process also incites an immune response     within the ablated tumor. Giving monoclonal antibodies such as pembrolizumab which enhance a     systemic anti-cancer immune response, may augment the effects of cryosurgery and increase     tumor killing at distant (metastatic) sites.   "
60830|NCT02489344|"     Primary Objective:      To assess the long-term safety of GZ/SAR402671 in adult male patients with Fabry disease who     previously completed study ACT13739.      Secondary Objective:      To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy     endpoints in adult male patients with Fabry disease who previously completed study ACT13739.   "
60831|NCT02489331|"     Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the     New Drug Re-examination   "
60832|NCT02489318|"     The purpose of this study is to determine if the addition of apalutamide to ADT provides     superior efficacy in improving radiographic progression-free survival (rPFS) or overall     survival (OS) for participants with mHSPC.   "
60833|NCT02489305|"     The purpose of this study is to identify if there are self-reported or objective measures     related to mood parameters that can predict near-term relapse (within 1 month or at another     identified time point before meeting the criteria for relapse) or early symptomatic changes     indicative of relapse prodrome in major depressive disorder (MDD).   "
60836|NCT02489266|"     Background:      - One cancer therapy involves taking white blood cells from a person, changing them in a lab,     and then giving the cells back to the person. These cells are called tumor infiltrating     lymphocytes (TIL). Researchers want to grow some of the TIL cells with the drug Akti to see     if they live longer than those grown without it.      Objectives:      - To see if TIL cells grown with Akti live longer than those grown without it.      Eligibility:      - Adults 18 70 with metastatic melanoma      Design:        -  Participants will:        -  Be screened with tests including scans, x-rays, heart and lung tests, blood and urine          tests, and a <TAB>possible colonoscopy.        -  Have tumor surgery or biopsy.        -  Have a large catheter inserted into a vein in the upper chest.        -  Receive leukapheresis for 4 5 hours. Blood is removed through a needle in an arm. White          blood cells <TAB>are removed. The rest of the blood is returned by needle in the other          arm.        -  The cells will be changed in a laboratory.        -  Participants will check into the hospital and:        -  For 5 days, get 1 2 chemotherapy drugs by catheter.        -  For 1 3 days, get the changed cells by catheter.        -  For several days, get 2 drugs to stimulate cells, one by injection, the other by          catheter.        -  For 7 12 days, recover in the hospital.        -  After treatment, participants will:        -  Take an antibiotic and antiviral for at least 6 months.        -  Return to NIH for several 2-day visits for a few years. At each visit, participants will          have lab tests, imaging studies, and a physical exam. At some visits, they may have          leukapheresis or blood tests.   "
60837|NCT02489253|"     Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in     500 in the UK. Our aim is compare the carotid and coronary artery atherosclerosis in     monogenic FH and polygenic hypercholesterolemia with means of a carotid ultrasound, a     coronary CT angiogram and biochemical biomarkers.   "
60838|NCT02489240|"     The investigators planned to research the effect of vitamin D supplementation on the     incidence of contrast-induced nephropathy in patients undergoing coronary angiography.   "
60839|NCT02489227|"     This is a 3-part study comparing CHS-1420 to Humira in patients with chronic plaque     psoriasis.   "
60840|NCT02489214|"     This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib     in advanced gastric cancer.   "
60841|NCT02489201|"     This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine     kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced,     inoperable oesophageal cancer progressing after chemotherapy .      The primary endpoint is the safety.The secondary endpoints are tumor response and     progression-free survival.   "
61039|NCT02486614|"     The aim of this study is to evaluate the effect of regional citrate anti-coagulation on     different pathways of the coagulation system in critically ill patients with acute kidney     injury. This will form the basis for future studies where the investigators plan to focus on     patients with premature circuit clotting despite optimal post-filtrate ionised calcium     parameters.   "
60843|NCT02489175|"     Parastomal hernia (PSH) is one of the most frequent stoma complications with a high impact on     patients' quality of life. Half of the stomas created each year are permanent and up to 50%     of the patients will develop a PSH. PSH rates depend on the type of ostomy, ileo- or     colostomy. End colostomy carries the highest risk for PSH (48%). PSH lead to recurrent pain,     poor fitting appliance with leakage and therefore, skin irritation, and can also be     complicated by strangulation or occlusion. The literature reports that 30% of patients with a     PSH will require surgery. There are many different surgical procedures to repair PSH: primary     fascia repair, relocation of the stoma or repair with various type of mesh. Despite the     efforts done to improve the techniques, the incidence of recurrent PSH is up to 70% dependent     of the used technique. Therefore, the idea of implanting a mesh at the time of initial stoma     formation has lately been advocated. A new device, the KoringKM, which is a stomaplasty ring     made of propylene, flexible and non-absorbable, was created. This study will try to prove     that incorporation of the new stomaplasty ring at the time of stoma creation will diminish     long-term PSH rate. This hypothesis will improve patient's quality of life and reduce costs     associated with PSH.      All patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant disease     and fulfilling the inclusion criteria are eligible to participate in the trial. The patients     will be randomized 24 to 48 hours prior to surgery after given written informed consent. The     implantation of the Koring will be perfomed by experienced surgeons (expertise based, best     team approach) who have already implanted the Koring (e.g. participated in the observational     study) and/or have reviewed the video documentation. The surgeon will fill out the first form     with the data of the patient and of the surgical procedure. The surgical wound will be daily     examined. A second form will be fill out during the 30 post-operative days visit. The     patients will be asked to inform the surgeon and/or investigator if any side event or     suspicion of infection occurs after hospital discharge. The next follow-up visits will be at     one and two years including a clinical examination and an abdominal CT. At this moment, the     3rd and 4th forms will be documented. All data will be anonymised and included in an Excel     database.   "
60844|NCT02489162|"     The objective of the research is to determine whether the MyotonPRO has a valid and reliable     application in facial, head and neck surgery. In addition, the study aims to compare this new     technology with current electromyography.   "
60845|NCT02489149|"     To optimize the food security in quilombolas communities with high prevalence of food     insecurity and obesity, the present study proposes to test a multi-sector intervention     including agriculture sectors, health professionals and family members of communities, based     on promotion of traditional food practices, health eating and enforceability of human right     to adequate food.   "
60846|NCT02489136|"     Stress is a multiple variable and an inevitable aspect of life. Any change that affects the     life of a person is a stressful agent, being possible to widely vary its nature and may be     formed by several components, since psychosocial and behavioral factors, such as frustration,     anxiety and overload. The goal is to assess the effects of laying on of hands on newborns and     patients without direct physical contact. Newborns are allocated in two three groups: G1 -     group submitted to imposition of hands by workers, for a period of 10 minutes; G2 group     submitted to laying on of hands for 10 minutes; and adults are allocated three groups: G1 -     group submitted to imposition of hands by workers, for a period of 10 minutes; G2 group     submitted to laying on of hands for 10 minutes; in G3: group without intervention, for a     period of 10 minutes.   "
60847|NCT02489123|"     This pilot clinical trial studies enzalutamide in treating patients with mantle cell lymphoma     that has returned after a period of improvement (relapsed) or has not responded to previous     treatment (refractory). Androgens can cause the growth of cancer cells. Antihormone therapy,     such as enzalutamide, may lessen the amount of androgen made by the body.   "
60901|NCT02488408|"     A Phase Ib/II multicentre open label study of BGb324 as a single agent in patients with AML     or MDS or in a combination with cytarabine and decitabine in AML patients.      BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein     kinase receptor which is overexpressed in up to half of AML cases.   "
60849|NCT02489097|"     The study is a substudy of the Enigma2 trial which aims at investigating the effectiveness     and safety of nitrous oxide (N2O) in anaesthesia.The substudy focus is on postoperative     cognitive disorders.      Substudy Hypothesis: In patients undergoing anaesthesia for major surgery, administration of     N2O will reduce postoperative cognitive disorders when compared with otherwise identically     managed surgical patients not receiving N2O as a component of their anaesthesia.   "
60850|NCT02489084|"     Background of the study:      Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side     effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and     have a major impact on the general dimensions of quality of life (QoL). In     radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume     parameters being used to determine the risk of acute and late RISE. NTCP models containing     genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may     improve model performance and thus enable more individualized radiotherapy. Information of     the predictive value of SNPs or SNP signatures among patients with HNC is currently not     available.      Objective of the study:      The main objective of this project will be to test the hypothesis that SNP profiles can     improve the performance of predictive models for the most frequently reported late RISE, i.e.     dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement     of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2)     acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6)     osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of     life.   "
60851|NCT02489071|"     This study evaluates the feasibility and utility of two behavioural programs designed to     reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of     participants will complete training in either program, with the remaining third a wait-list     control group.   "
60852|NCT02489058|"     This is an observational and sample collection study involving patients (alive or deceased)     from several clinical trials who had received the investigational drug, olaparib in other     research studies. There is no intervention given for this study.      This research is being done to understand of the mechanisms involved in patients whose cancer     responds well and whose cancer does not respond well to investigational drug, olaparib, to     help better understand how olaparib works and to better identify patients who may benefit     from this therapy.   "
60927|NCT02488070|"     This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA)     (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography     (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying     prostate cancer that may have returned after a period of improvement (biochemical     recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer     receptor, which can then be imaged by the PET/CT or PET/MRI scanner.   "
60853|NCT02489045|"     This is an open-label, non-randomized trial that will be conducted at two clinical sites,     Thomas Jefferson University (TJU) and the Hospital of the University of Pennsylvania (HUP).     Enrolled patients undergoing trans-jugular liver biopsy with hepatic vein pressure gradient     (HVPG) measurements will receive a continuous infusion of Sonazoid® (GE Healthcare, Oslo,     Norway) co-infused with 0.9% NaCl solution over a 5-10 minute time period. Ultrasound imaging     will be performed using a Logiq 9 scanner with a 4C transducer (GE Healthcare, Milwaukee, WI)     and the novel SHAPE (subharmonic aided pressure estimation) algorithm will be used to measure     pressure values in the hepatic and portal veins. Data will be stored on a PC and compared to     pressure-catheter measurements, Subjects identified in the initial examination as having     portal hypertension (by HVPG results) will be monitored by SHAPE for up to 18 months. These     subjects typically have surveillance Computed tomography (CT) or magnetic resonance imaging     (MRI) scans every 6 months to screen for liver cancer, and at those times a repeat SHAPE     examination will be performed (ideally within 1 month of their clinically indicated imaging     follow up appointment). In patients who undergo more frequent screening (generally 3 month     intervals), SHAPE exams will be performed at 6 month intervals. Any repeat trans-jugular     liver biopsies performed in this population will also trigger a repeat SHAPE study. Results     of blood test evaluations (performed every 3 months in this population), medication,     concomitant imaging study or procedure (including endoscopies) will be noted (all blood tests     and imaging are clinically indicated only and are not required by this protocol). The end     point for this part of the study will be any one new complication (e.g., liver cancer) or a     marked worsening in any complication, liver transplantation, death, or the end of this     clinical trial (after 3 years). The investigators expect these patients will be monitored     three times during the course of this clinical trial. The time to reach the end point will be     noted if a new complication or a marked worsening in any complication occurs.   "
60854|NCT02489032|"     The goal of the proposed research is to complete the development of a web-based program to     train Employee Assistance Program (EAP) and EAP-affiliated managed behavioral health     organization (MBHO) practitioners to conduct screening, brief intervention, and referral to     treatment (SBIRT) for problem alcohol use among working adults.   "
60855|NCT02489019|"     Hypotension is frequently encountered after induction of general anesthesia. It can be     pronounced in elderly patients and can require administration of vasopressor agents including     ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged episodes, can     contribute to an increase in morbidity and mortality in the postoperative period as suggested     by some former studies. The investigators hypothesize that fentanyl can contribute to the     decrease in blood pressure (BP) that is seen after induction of general anesthesia in older     patients. This hypotension may be due to fentanyl blocking effect on the sympathetic nervous     system.      This study will be the first one to examine the effect of fentanyl administration on blood     pressure in elderly patients with induction of general anesthesia prior to the start of     surgery. If the study shows that fentanyl contributes to hypotension during this period, it     may lead to a change in practice and better patient outcomes and mortality rates.   "
60856|NCT02489006|"     This is a study that will look at the effects and how useful investigational drug olaparib is     as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment)     prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube     cancer.   "
60857|NCT02488993|"     This study evaluates hepatic encephalopathy (HE) and liver-related hospitalization rates and     duration of stay in patients with HE treated with rifaximin-α 550mg compared to patients     receiving other therapies.      This registry study aims to comprehensively and rigorously characterize the impact of     rifaximin-α 550 mg on hospitalization, clinical safety and effectiveness outcomes, and     quality of life in patients with HE in Europe and Australasia.   "
60858|NCT02488980|"     This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy     of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of     P. falciparum in Nyanza Province, western Kenya.   "
60859|NCT02488967|"     This randomized phase III trial studies how well doxorubicin hydrochloride and     cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients     with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin     hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and     cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and     carboplatin in treating triple-negative breast cancer.   "
60860|NCT02488954|"     Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results     at least in part of an abnormal immune response to environmental factors including the     intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide     health benefits when consume) may restore the gastrointestinal microbiota and reduce     intestinal inflammation.      Propionibacterium freudenreichii is used for the production of fermented food products     (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based     on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may     decrease disease activity during ulcerative colitis.   "
60861|NCT02488941|"     Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic     liver disease in the western world and an important cause of morbidity and mortality     including risk of cardiovascular disease. A ruling dogma is that a fatty liver is     well-functioning. Recent studies imply the contrary but quantitative measurements of     metabolic liver function have not been systematically investigated in NAFLD.      Objectives: To study and quantify specific metabolic liver functions in varying degrees of     NAFLD. Furthermore to map the coagulation system of patients with NAFLD.      Methods: A human clinical study. Metabolic liver functions are studied by a series of     functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT),     Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance     (FHNC)). Regional liver function evaluated by 2-[18F]fluoro-2-deoxy-D-galactose (FDGal)     PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary     and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated.      Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in     NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD,     histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant     imbalance in NAFLD.   "
60952|NCT02487745|"     The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of     a Wage Supplement Model of arranging long-term exposure to employment-based abstinence     reinforcement.   "
61882|NCT02475616|"     This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study     to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in     healthy adult males.      Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.   "
60866|NCT02488876|"     The aim of this study is to collect non-individual related blood samples for the compelling     of a unique database of tissue samples to understand the inflammatory responds after cardiac     surgery on an on-going basis. This includes especially protein analyses and genetic testing     for certain neurotransmitters in the blood and tissues to understand disease markers related     to heart disease. The study is designed as an openly recruiting biobank with the purpose to     later serve multiple study purposes. Outcomes refer to protein analyses and genetic testing     for neurotransmitters in the blood and tissues.   "
60867|NCT02488863|"     Osteoarthritis (OA) represents the leading cause of disability worldwide, and the knee is the     most commonly affected joint. Knee OA has been traditionally attributed to peripheral     mechanisms, but peripheral damage, inflammation, and psychological factors have failed to     significantly account for the presence, absence, or severity of chronic OA-related pain.     Recent studies show that individuals with OA-related pain exhibit dysfunctional pain     modulation supporting a significant central nervous system (CNS) contribution. However, the     CNS mechanisms underlying these changes in pain modulation are not currently known, nor their     relation to clinical pain progression. The proposed pilot examines brain circuits recently     described in predicting the transition from acute to chronic pain, in predicting clinical and     experimental pain changes as well as physical performance and mobility changes in older     persons with knee OA pain over a one year period. The findings will provide novel and     important information regarding the mechanisms underlying aberrant pain processing and its     functional consequences in older adults with knee OA. The information learned can be     subsequently used to target treatment and prevention strategies in future studies of older     adults. The central hypothesis is that increased functional and structural connectivity of     cortico-striatal regions will be significantly associated with baseline clinical and     experimental pain and decreased physical function in persons with symptomatic knee OA and     will account for more rapid clinical pain and disability progression overtime.   "
60868|NCT02488850|"     Rationale: An anatomical surgical resection is considered to be the standard of care in fit     patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is     less frequently performed in both elderly patients (aged ≥75 years), who represent the     fastest-growing group of patients with stage I/II NSCLC, and in patients who have significant     co-morbidity. Following the introduction of stereotactic ablative radiotherapy (SABR), an     outpatient treatment that is typically delivered in between 3-8 fractions, the median     survival of all elderly patients undergoing radiotherapy in The Netherlands increased by 9.3     months. Randomized trials comparing SABR and surgery have yet to be completed and results of     the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A recent data     retrospective study comparing both modalities has raised interesting questions about the     impact of local therapy on recurrence patterns. It was found that a better loco-regional     disease control rate was achieved with SABR.      Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary     endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients with     early stage non-small cell lung cancer who are treated with either modality.      Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven     NSCLC.      Main study parameters/endpoints: To determine whether an increase in CD8 activity can be     established after SABR in patients with early stage lung cancer and to compare this increase     with that in patients undergoing a surgical intervention. Nature and extent of the burden and     risks associated with participation, benefit and group relatedness: Only risks in     participation are the risks with drawing blood. Subjects will not have any benefits. This     pilot study will be used to generate information concerning both treatments useful for the     decision to plan a future study in a larger series of patients.   "
62112|NCT02472587|"     The purpose of this study is to determine the percentage of women, among those attending our     institute in order to do Pap test, suffering of chronic pelvic pain. To such purpose the     patients will be submitted to questionnaires.   "
60869|NCT02488837|"     The purpose of the study is to determine if non-invasive measurements of brain waves from the     skin called electroencephalography (EEG) can predict whether the brain stimulator will help     your symptoms. Our goal is to obtain these brain wave measurements with patients both awake     and under general anesthesia, and then to evaluate which brain wave patterns are associated     with clinical improvement to determine if they could be useful for predicting whether the     surgery will work. If such predictive measures were established based upon the findings of     this study, they could be used in the future to improve surgical outcomes in the following     ways: (1) to help guide surgical targeting in the operating room awake or under anesthesia,     (2) to guide post-operative programming in clinic, and (3) and to develop potential feedback     systems for automatic programming of the brain stimulator system at home.   "
60870|NCT02488824|"     The ability to maintain normal body temperature (Tcore) is impaired in persons with     tetraplegia: subnormal Tcore and vulnerability to hypothermia (<95 F) have been documented in     this population after exposure to even mild environmental temperatures. However, no work to     date has addressed the effect of subnormal Tcore on cognitive performance in persons with     tetraplegia despite studies with able-bodied (AB) individuals that have documented     progressive decline in various aspects of cognitive performance associated with the magnitude     of the depression in Tcore. The investigators' study will confirm and extend their initial     observations in persons with higher cord lesions who have subnormal Tcore to show that     cognitive performance will be improved by raising Tcore to euthermic levels. This improvement     should be associated with greater function and independence, reintegration into society, and     an improved quality of life.      Specific Aims: During exposure to 95 F for up to 120 minutes in the seated position, the     investigators' aims are:      Primary Specific Aim: To determine if a modest rise in Tcore to euthermic levels has a     positive effect on cognitive performance (attention, working memory, processing speed, and     executive function) in persons with higher-level spinal cord injury (SCI).      Primary Hypothesis: Based on the investigators' pilot data: (1) 80% of persons with SCI will     demonstrate an increase of 1 F in Tcore, while none of the AB controls will demonstrate such     an increase; (2) 80% of persons with SCI will have an improvement of at least one T-score in     Stroop Interference scores (a validated measure of executive function), while none of the AB     controls will demonstrate a change in cognitive performance.      Secondary Specific Aim: To determine changes in: (1) The average of distal skin temperatures;     (2) Sweat rate; and (3) Subjective rating of thermal sensitivity.      Secondary Hypothesis: Persons with SCI will have less of a percent change in average distal     skin temperatures and sweat rate, and will report blunted ratings of thermal sensitivity     compared to that of AB controls.   "
60871|NCT02488798|"     100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D     power Doppler ultrasound using the international endometrial tumor analysis group and office     hysteroscopy with taking samples for histopathological analysis.   "
60872|NCT02488785|"     The goal of this study is to evaluate the impact of a comprehensive diabetes education and     management program based on frequent communication with patients using teleconsultation, text     messaging, and phone calls on diabetes related outcomes in Latino patients with type 2     diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the     baseline and the six-month visit will be at least 0.5 percent greater in the intervention     group than in the control group.   "
60917|NCT02488200|"     The present study plans to delineate the clinical, biochemical, sociological and     psychological factors. involved in dialysis preparation, and their impact on dialysis     initiation (DI), modality choice and prognosis. In particular the following questions are to     be answered.        1. What factors influence unplanned DI?        2. What factors influence choice of dialysis modality?        3. What factors influence choice of dialysis access?        4. Why do physicians start dialysis?        5. What factors in the predialytic period and its immediate aftermath (the peridialytic          period) influence prognosis?   "
60873|NCT02488772|"     Background The emergency department is a chaotic place with high levels of noise and light 24     hours a day. Patients are often boarded overnight while they await tests or consultations     scheduled for the morning. Sleep deprivation, high noise levels have been associated with     negative patient experiences and outcomes in other clinical settings. Interventions to     counter the effects of noise and light in the emergency department for patients staying     overnight have not been investigated.      Objective To determine if sleep and other aspects of the patient experience can be improved     for patients boarded overnight in the Emergency Department with the use of a sleep mask and     ear plugs.      Methods A randomized control study will take place in the Emergency Department of Kingston     General Hospital. Eligible patients will randomized to receive either sleep aids (sleep mask     and ear plugs) or standard treatment (no sleep aids). The primary outcome will be sleep     quality, assessed by Richards-Campbell Sleep Questionnaire. Secondary outcomes include     patient satisfaction, hours of sleep, blood pressure, heart rate, new-onset delirium,     patient's sense of feeling well-rested and patient overall sense of well-being. The primary     analysis will be intention-to-treat comparing primary and secondary outcomes between the two     groups in an unadjusted fashion. A secondary analysis will involve linear regression to     explore the association between treatment group and Richards-Campbell Sleep Score,     controlling for potential confounders.      Importance Determining the feasibility and efficacy of sleep masks and earplugs for patients     in the emergency department to improve sleep and the patient experience has never been done     before. If found to be effective, this relatively low- cost intervention could be implemented     in emergency departments across the country and around the world.   "
60875|NCT02488746|"     Prospective observational trial. A full thickness resection of gastric subepithelial tumors     is performed after application of full thickness sutures underneath the tumor with the     GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.   "
60876|NCT02488733|"     Bariatric surgery is efficient in both inducing adequate weight loss and the control of     glycemia in obese patients affected by Type 2 Diabetes Mellitus (T2DM).      Despite growing evidence suggesting that early performance of bariatric surgery on obese     patients with T2DM offers the best opportunity to reach and maintain a remission of diabetes,     no randomized clinical trials (RCT) have evaluated its efficiency in patients with new T2DM     diagnosis.      The aim of this RCT is to compare bariatric surgery, and in particular Laparoscopic Sleeve     Gastrectomy (LSG), with conventional medical therapy (CMT) in patients with new T2DM     diagnosis that are obese (Body Mass Index, BMI of between 30 and 42 Kg/m2), to be recruited     at two Italian diabetology centres (Terni and Rome).      The main objective of the present RCT is to investigate the efficacy of LSG as compared with     CMT in inducing and maintaining both a resolution of T2DM (defined as HbA1c levels ≤6.0%,     without active pharmacologic therapy or ongoing procedures) and the remission of T2DM through     the evaluation of the criteria provided by the American Diabetes Association (ADA) at maximum     follow-up of 6 years. The effects of the two treatments in terms of weight loss and the     quality of life of the patient will also be taken into consideration.      Any positive results of this study will include preventing microvascular and macrovascular     complications connected with diabetes, without the necessity to take medication, and at the     same time the loss of excess body weight and improved quality of life (QOL).   "
61157|NCT02485067|"     The primary purpose of this study is to assess the efficacy and safety of     THVD-201(Combination of tolterodine and pilocarpine) in patients with Overactive bladder     during the period of treatment, 12 weeks.      This study also includes an open label extension period of an additional 12 weeks following     the treatment to assess long-term efficacy and safety of THVD-201 in patients with Overactive     bladder.   "
60877|NCT02488720|"     The LEARN study a multicenter, observational study will that will evaluate the rate of     cognitive change in approximately 500 clinically normal older individuals who screen-fail     for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of     elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria.     This study will leverage the A4 infrastructure and maximize the data acquired in screening a     large number of well-characterized older adults for the A4 trial.      The LEARN observational cohort will provide a critical comparison group for the A4 placebo     arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest     that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it     is important to demonstrate a differential rate of clinical decline between Aβe (Aβ     elevated) and Aβne (Aβ not elevated) individuals on a standardized set of clinical     outcomes. Over 2000 well-characterized, highly motivated older volunteers will screen fail     for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as     possible to the two treatment arms, in this observation cohort. The LEARN study may     selectively recruit from a specific range of SUVr that fall below the threshold for elevated     amyloid in order to support analyses of the relationship of baseline SUVr to subsequent     cognitive change and amyloid accumulation. The observational cohort will be followed for 168     weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to     the A4 treatment study.   "
60878|NCT02488707|"     A prospective study is planned for management of low rectal cancer with the aim of sphincter     preservation and improving the oncological outcome of the patients, through comparing of both     approaches minimally invasive techniques including transanal total mesorectal excision and     laparoscopic intersphincteric resection.   "
60879|NCT02488694|"     This study aims to compare the efficacy of afatinib maintenance with pemetrexed maintenance     following induction therapy with platinum/ pemetrexed in patients with metastatic epidermal     growth factor receptor (EGFR) mutated non-small-cell lung cancer (NSCLC) progressing after     first-line treatment with afatinib with respect to progression-free survival.   "
60880|NCT02488681|"     Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to     the Micra System while the marketing application is under review by the Food and Drug     Administration (FDA).   "
60891|NCT02488538|"     Three hundred women with severe premenstrual syndrome will be divided into 3 groups using     computer generated random numbers. Group 1 will receive COC containing drospirenone     (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® ScheringAG, Egypt) daily for 21 days     starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2     will receive COC containing drospirenone daily for 21 days starting from the 3rd day of     menstruation in addition to a daily oral placebo similar in size, color and structure to     fluoxetine . Group 3 will receive oral placebo similar to COC daily for 21 days starting from     the 3rd day of menstruation in addition to a daily oral placebo similar in size, color and     structure to fluoxetine.   "
60881|NCT02488668|"     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously     difficult to treat. Amputation usually follows traumatic injuries or surgery following     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is     required for the survival of the patient. The loss of a limb or other body parts is usually     followed by the sensation that the lost body part is still present and can be felt. These     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure     on the residual limb) and psychological factors (e.g. emotional stress). It is well known     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,     psychological and other, are ineffective.      Today it is believed that phantom limb pain may be related to changes in the cortex of the     brain. There is evidence that these changes may be modulated - or even reversed - by     providing sensory input to the stump or amputation zone. For example, cortical reorganization     and alleviation of phantom limb pain has been observed in amputees following intense use of a     hand prosthesis. However, there is no consistent knowledge on which type of peripheral     sensory feedback may be effective in affecting the cortical plasticity or on how to best     apply the sensory feedback.      The aim of the proposed research is to create natural, meaningful sensations through     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.   "
60882|NCT02488655|"     This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with     the FastScan version using assessment of patient experience and adverse event reporting.   "
60883|NCT02488642|"     The purpose of this study is to assess the therapeutic efficacy and safety of isosorbide     dinitrate-oxytocin in combination in the management of late intrauterine foetal death.   "
60884|NCT02488629|"     To evaluate the safety and efficacy of SCB01A in head and neck cancer.   "
60886|NCT02488603|"     This is an educational intervention study for breast cancer patients who undergo tamoxifen     treatment. The purpose of the study is to assess the impact of decision aids (DA) on the     patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen     treatment. Patients will randomly assign to DA group or conventional group. Both groups will     have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later     follow-up questionnaire surveys.   "
60887|NCT02488590|"     The differential diagnosis of asthma and COPD is sometimes difficult. Recently, an overlap     syndrome has been defined based on the concurrence of asthma and COPD characteristics. These     characteristics are based on expert opinions and have never been investigated nor validated     prospectively.      The investigators assume that the management strategy, the symptom burden and disease     progression will differ between asthma, COPD and ACOS. Therefore, the study wants to     establish baseline criteria for an appropriate disease definition and evaluate the potential     impact on treatment and symptom control.   "
60888|NCT02488577|"     Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive     total mesorectal excision or transanal minimally invasive locoregional resection.   "
60968|NCT02487537|"     Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft     drinks may play a role in the development of diabetes.      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence     metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and     even modulate incretin release.      Data on human subjects are sparse and controversial, especially in a long-term manner. We     therefore conduct a cross-over study to assess metabolic response to sweetened vs.     non-sweetened soft drinks, which are consumed over a period of 4 weeks.   "
60889|NCT02488564|"     It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and     potential early predictors of response in neoadjuvant setting. Patients with operable breast     cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer     (T4a-d, N0-N2, M0) with overexpression or amplification of HER2 (AJCC 7th edition 2010) are     included in the study.      The primary objective is to evaluate the pathological complete response rate (pCR).      The secondary objectives are:        -  to evaluate the clinical response rate (RR).        -  to evaluate the feasibility and systemic tolerance, with particular attention to cardiac          toxicity.        -  to evaluate the conservative surgery rate.      Total duration of the trial is 36 months; planned treatment are 6 cycles of chemotherapy. At     every cycle (every 21 days) will be administered:      Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9:     Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first     infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin     is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be     administered once a day; from day -10 Metformin 1000 mg will be administered twice a day     continuously until end of the study treatment.   "
60890|NCT02488551|"     Background and Significance: Randomized Controlled Trials (RTCs) have demonstrated that     evidence-based psychotherapies (EBPs), particularly Cognitive Behavioral Therapy (CBT), are     highly effective in treating anxiety and depression, the most common mental health disorders     in primary care settings. Mental health (MH) providers in VA     Community-Based-Out-Patient-Clinics (CBOCs) are often located in rural areas and isolated     from educational opportunities. Almost half of Veterans now use CBOCs. Studies have shown     that the quality of delivery of EBPs (fidelity) impacts clinical outcomes. This study will     test a computer-assisted tool (CALM Tools for Living) that increases fidelity to CBT in     treating depression and four common anxiety disorders, including PTSD. Although results of a     large RCT, the CALM study, suggested that the tool contributed to fidelity to the CBT     protocol, this hypothesis has not been tested. This study will test the tool in primarily     rural CBOCs in VA VISN16.      Objective: To modify a computer-assisted CBT tool to meet the needs of CBOC MH providers and     Veterans, to evaluate the impact on providers' fidelity to the CBT model and clinical     outcomes, and to assess how best to support future implementation.      Specific Aims/Hypothesis: (1) Engage CBOC MH providers in modifying the computer-assisted CBT     tool such that its content is relevant and acceptable to Veterans and providers. The     investigators hypothesize that the modified tool will be acceptable to both Veterans and     providers. (2) Compare MH provider fidelity to CBT and clinical outcomes among providers who     used the tool and those who did not. The investigators hypothesize that clinicians who use     the tool will have a higher fidelity to CBT and clinical outcomes among patients will be     superior. (3) Prepare for future implementation of the tool in the VA.      Methodology: This study will use a Type III hybrid effectiveness design. Methods common to     the field of Instructional Design and Technology (IDT) will be used to modify the tool.     Thirty-four CBOC MH providers will be trained in CBT and randomized to use the tool or not.     Both groups will receive external facilitation to encourage the full implementation of CBT     into practice on the clinic level. MH providers will treat 10 patients each. Patients will be     assessed at baseline, 3, 6, and 12 months. Provider fidelity to the CBT protocol will be     measured, and finally, a tool kit for future implementation of the tool will be disseminated.      Impact: The investigators expect the intervention to improve the technical quality of MH     treatment in CBOCs and improve clinical outcomes among Veterans.   "
60892|NCT02488525|"     Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor     concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD)     reduces the frequency of clinically significant bleeding within 3 months after implantation     in comparison to the usual care. Adult patients with functional defects of VWF measured after     implantation of continuous LVAD are randomly assigned to prophylactic treatment.   "
60893|NCT02488512|"     This is a prospective, single arm,single centre open-label, phase II study in relapsed or     refractory DLBCL and MCL non-Hodgkin's lymphoma (NHL), not suitable to other therapies,     included HDCT, or patients relapsed after high-dose chemotherapy (HDCT) with autologous     stem-cell transplantation (ASCT), treated with peptide receptor radionuclide therapy with     90Y-Dotatoc.      Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi),     divided into 4 cycles (1.8 - 2.8 gigabequerel (GBq) for each cycle) with an interval of 6 - 8     weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.      35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2     or fewer patients will show an objective response, the study will be closed).   "
60894|NCT02488499|"     This study investigates the effectiveness of a clinic-adapted version of the Coping Power     program compared to individualized child and family treatment for children with disruptive     behaviour and their parents.   "
60895|NCT02488486|"     This pilot study evaluates the effectiveness of a closed-loop administration of propofol and     remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.   "
60896|NCT02488473|"     Brief Summary: The aim of this trial is to investigate if dexmedetomidine prolongs the     duration of an adductor canal block. By using healthy volunteers the investigators can     perform a bilateral adductor canal block and thereby control for a systemic effect to clarify     if the effect is actually peripheral or systemic. The investigators hypothesis is that     dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral     nerve block by a peripheral mechanism.   "
60897|NCT02488460|"     Background      Increased physical activity can improve cognition and academic skills. However due to     economic concerns and increasing focus on standardized testing, PA in schools often receives     little attention and physical education is reduced in many countries in favor of spending     more time devoted to academic classes. This tendency is not compatible with the increasing     evidence for the association between physical activity, fitness, cognitive and academic     performance.      Despite increasing evidence for the association between PA, fitness, cognitive and academic     performance, very few longitudinal high-quality studies exists examining the effect of     physical activity on academic performance (ref.). Furthermore, to the best of our knowledge     only two studies have assessed academic outcomes following the integration of physical     activity into the classroom with intervention participants scoring significantly higher in     test sections compared to controls which makes generalizing from these results challenging.      To promote policy changes that require more physical activity in school, empirical data are     needed to study the effects of school-based physical activity programs. Therefore the     investigators carried out a cluster randomized controlled trial conducted to examine the     effect on math achievement and executive functions of classroom based PA in math.   "
60898|NCT02488447|"     The purpose of ths study is to evaluate changes in life quality of patients affected by     rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an     observational, prospective and comparative study before-after immunotherapy treatment with a     one year follow-up.   "
60899|NCT02488434|"     The aim of the current study is to evaluate to effectiveness of sperm selection by using     fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI)     cycles.   "
60902|NCT02488395|"     The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier     Parkinson's disease, using the superior colliculus as a biomarker.      Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest     that the superior colliculus, a sensory structure, show an early deficit in visual     processing. The investigator's data also suggests that with the evolution of the disease,     this structure presents a neuronal re-organisation leading which causes a sensory rebound     after the introduction of the treatment. The light responses in the superior colliculus were     faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an     important question about the superior colliculus functional state in Parkinson's patients. If     this structure have a similar neuroplasticity, the investigators could hypothesize that the     superior colliculus may also present a sensory rebound when introducing the treatment. If     this hypothesis is true, the accelerated and amplified light responses of this structure may     explain the difficulties felt by the patients to inhibit reflexive saccades induced by the     appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in the     orientation of the head and eye toward any sudden changes in our environment (Wurtz and     Albano, 1980) and the light responses of this structure are strongly correlated with the     speed of the saccade (Marino et al., 2012).      Therefore, the investigators want to test if a similar deficit could be observed in the     superior colliculus of newly diagnosed PD patients. Data will be compared to matching     controls.   "
60903|NCT02488382|"     The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a     pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing     sufficient number of stem cells for autologous stem cell transplantation in patients with     lymphoma and multiple myeloma.   "
60915|NCT02488226|"     This project seeks to understand how the gaze behavior of infants and children with or at     high risk for autism spectrum disorder (ASD) may be manipulated in the contexts of dynamic     social and non-social scenes. The study explores not only the methods which may be most     effective in aligning and teaching normative patterns of scene exploration, but also seeks to     establish what behavioral characteristics may be most predictive of atypical scanning and     atypical learning.   "
60916|NCT02488213|"     Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in     Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a     nutritional counseling directed to offer benefits in metabolic control in diabetic patients.   "
60904|NCT02488369|"     This is a diagnostic prospective multicenter study. This study will be conducted in 32     centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent     (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the     SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated with     conventional imaging time of remission assessment. Histological examination of residual tumor     will be conducted whenever practicable in patients with pathologic residual image on     conventional imaging and / or PET / CT. A central review of conventional imaging examinations     and PET / CT will be performed independently from each other.      Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET / CT     (between J8 and J28 according to the type of lymphoma and toxicities due to treatment). The     results of the early PET / CT should not lead to treatment modifications.      In case of residual tumor at remission assessment, therapeutics changes as recommended     therapeutic protocols will be based on histologic findings and not on the results of PET / CT     alone.   "
60905|NCT02488356|"     Safety and Efficacy of Litramine in weight loss.   "
60906|NCT02488343|"     Adherence is an active process wherein the patient acts in collaboration with the medical and     paramedical staff in order to improve his/her health. Adherence to medication comprises of     implementation and persistence and it is estimated to be around 50% in various chronic     illnesses, including Multiple Sclerosis (MS). MS patients who fail to properly adhere to     their DMTs regimen may be at increased risk for the development of new central nervous system     lesions, exacerbations, increased disabilities and poorer quality of life. Plausible reasons     for the low adherence rates in MS mentioned in the literature include patients' attributes,     condition attributes and therapy related factors.      The objective of this study is to develop a personal profile of adherence based in the     factors mentioned above. In the first part of the study patients will be followed up and the     profile My Multiple Sclerosis Perception Adherence Scoring System (MyMS_PASS) will be created     and tested. In the second part, patients with non-optimal rates of adherence will receive     tailored intervention in order to improve therapy to treatment. This work may serve as a     model for the study of adherence to therapy and the development of interventions in MS as     well as in other chronic diseases.   "
60907|NCT02488330|"     This extension study will provide continued onartuzumab and/or parent trial (P-trial)     designated control treatments to participants with cancer who were previously enrolled in a     company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible     investigator, from the therapy administered in the P-trial. The study will also collect     safety data with regard to administration of continued onartuzumab therapy.   "
60908|NCT02488317|"     Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to     identify factors that matter the most to patients with kidney disease and study how they are     impacted by different types of dialysis. The inclusion of patients, caregivers, and patient     advocacy organizations as research partners will assure that the study addresses questions of     greatest relevance to patients facing the need for dialysis.      For Aim 3, the investigators are going to compare measures related to the decision-making     process between patients receiving and not receiving a decision aid focusing on Peritoneal     Dialysis and Hemodialysis.   "
60909|NCT02488304|"     The objective of this study is to detect BOS in an early stage by using the outcome     parameters generated by Functional Respiratory Imaging (FRI). Robust and automated     segmentation algorithms will be developed for these parameters, focusing on quantitative     computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics     tool. The evolution of rejection over time will be monitored using non-rigid image     registration methods.   "
60910|NCT02488291|"     The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor     in primiparas so as to decrease perinatal complications of analgesia labor.   "
60911|NCT02488278|"     The GlucoMe device, in its original packaging, along with the user manual and QuickStart     guide will be provided to the patient in a simulated home use environment. The patient     labeling will be in the format intended for distribution.      Ten (10) subjects identified as potential end users of the GlucoMe device will receive the     user manual. An additional ten (10) subjects also identified as potential end users of the     GlucoMe device will NOT receive the user manual. All subjects will be provided with a     pre-test and post-test questionnaire and a list of tasks to complete, including applying and     operating the device.      The observer and user post-test questionnaire will collect information regarding device use.     The device's use will be compared with identified risks to determine if the percentage of     failures is within the study protocol success criteria. Additionally, measurable usability     criteria for specific, critical steps will be evaluated.   "
60912|NCT02488265|"     Postural instability is a particularly incapacitating disorder, where loss of motor     independence by Parkinson´s Disease (PD) patients marks a significant stage of disease onset.     Evidence suggests that deficits in automatic motor control, sensory integration and attention     are associated with lack of balance in PD. Physiotherapy, together with medication, plays an     important role in the treatment of this state, although no consensus has been reached on the     best treatment modality. The aim of this randomized controlled trial protocol is to evaluate     the effects of balance training with rhythmical (BRT), which is a motor program to improve     balance associated with rhythmical auditory cues (RACs)   "
60913|NCT02488252|"     This study aims to explore the effect of an adjuvant semi-individualized Chinese medicine     treatment plan on type 2 diabetic patients with stages 2 to 3 chronic kidney disease and     macroalbuminuria. This study will collect preliminary data on treatment effect, variance,     recruitment rate and attrition rate for the planning of a subsequent clinical trial.   "
60914|NCT02488239|"     The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the     performance of the Ingenio 2 CRT-P devices and to document that device-related events, device     malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P     devices (CRT-Ps), both in general and specific to the new features and hardware of the     devices.   "
60918|NCT02488187|"     Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging     (MRI) in Newly Diagnosed Breast Cancer Patients.   "
61883|NCT02475603|"     Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During     Total Knee Arthroplasty:      WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy     analysis   "
60919|NCT02488174|"     Severe acute respiratory failure (ARF) requiring prolonged mechanical ventilation is the most     common form of acute organ dysfunction in the hospital, and is often associated with multiple     organ failure (MOF), high mortality, and functional impairment. Most studies on ARF have     focused on patients in the intensive care unit (ICU) after they have been on mechanical     ventilation for days and end organ damage is already established. The overall goal of this     proposed project is to improve the outcomes of patients at high risk for developing severe     ARF and prolonged mechanical ventilation in and outside of the ICU. The project aims to     intervene early in high risk patients with an electronic medical records (EMR)-based,     patient-centered checklist of common critical care practices aimed at preventing lung injury     and hospital acquired adverse events that commonly lead to organ failure (Prevention of Organ     Failure checklist -PROOFcheck). This application proposes a stepped-wedge, clustered     randomized control trial to determine the utility of PROOFcheck to improve survival and     reduce the duration of mechanical ventilation and multiple organ failure in patients     identified as high risk for progressing to severe ARF and prolonged mechanical ventilation.     The aims in the UH2 phase are: 1) to refine a previously validated Lung Injury Prediction     Score into a pragmatic, EMR-based early prediction model to Accurately Predict Prolonged     Ventilation (APPROVE), which will automatically identify patients anywhere in the hospital     who are at high risk for developing severe ARF requiring mechanical ventilation >48 hours; 2)     to incorporate PROOFcheck into the EMR to prompt clinicians on care practices to limit lung     injury, prevent adverse events, and avoid additional organ failure; and 3) to establish the     infrastructure for the proposed trial. The proposed pragmatic trial will harness the     hospital-wide EMR to identify patients at high risk for prolonged mechanical ventilation with     APPROVE for intervention with PROOFcheck. As such, the proposed trial aims to break out of     the clinical silos by which care is currently organized in the hospital and bring     patient-centered, context appropriate care to the acutely ill patient wherever and whenever     the patient's condition requires it.   "
60920|NCT02488161|"     Coordinated multi-center project with several complementary goals in each one of the     sub-projects included. Objectives: 1.To determine risk factors of death, or major     complications in the short term; 2.To determine risk factors of death, tumor recurrence,     major complications, readmission or deterioration of quality of life in the mid term;     3.Evaluation of patient reported outcomes from before the intervention to the end of the     follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar     adverse results. This sub-project (coordinator) will approach the determination of risk     factors of death, tumor recurrence, major complications, readmission and deterioration of     quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with 2     years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6     Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically     intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic,     immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to     study. Statistic analysis: a derivation sample will be created where the possible predicting     parameters will be identified, by cancer of colon or rectum. Predictive models will be     created with a good discriminative capacity. A validation of those models will be performed     in a validation sub-sample. Logistic and Cox regression models will be used. Simulation     models for the prediction of discreet events in the long term will be used.   "
60921|NCT02488148|"     Arterial stiffening and endothelial dysfunction are correlates of advancing age contributing     to the decline in cardioprotection with age. Arterial stiffness and endothelial dysfunction     are emerging risk factors for cardiovascular disease and predict future cardiac events.     Vascular function has long been a target for lifestyle interventions with several studies     showing improvements traditional exercise modes. However, the impact of yoga on vascular     function remains elusive. This study will determine the effect of a 12-week Bikram yoga     intervention on arterial stiffness and endothelial function in healthy, middle-aged adults.      The overall aim of this study is to determine the efficacy of Bikram yoga in improving     vascular endothelial function and arterial distensibility in middle-aged adults with risk     factors for coronary artery disease and to determine whether the heated environment plays a     role in mediating these alterations in vascular function. The investigators propose to     conduct a 12-week Bikram yoga intervention study in sedentary individuals in order to test     the following hypotheses:        1. Bikram yoga will elicit reductions in arterial stiffness and enhancements in endothelial          function in sedentary, middle-aged adults.        2. The postulated effects of Bikram yoga will be greater when practiced in a heated          environment.   "
60922|NCT02488135|"     Nosebleeds that persist even after adequate traditional nasal packing may require aggressive     treatment strategies to stop bleeding. Currently these strategies include a surgical approach     to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix is a gel     like medical therapy that is inserted into the nose and is engineered to stop bleeding in     severe cases, possibly avoiding the need for surgery. In this study the investigators will     randomize patients to either receive FloSeal Hemostatix matrix or traditional nasal packing     as a treatment for severe nosebleeds. The main outcome will be whether the investigators are     able to stop bleeding with FloSeal or traditional packing alone and whether additional     measures are necessary to stop the bleeding. The investigators will also perform a patient     comfort survey and cost analysis. Even if FloSeal has equal effectiveness in treating     nosebleeds as traditional packing, if it is much more comfortable for patients then it may be     the favourable treatment.   "
60923|NCT02488122|"     Osteoporosis has become a worldwide concern an a matter of public health as osteoporosis is a     major contributing factor associated with insufficiency fracture of the spine, wrist and     proximal femur, and as a result, can diminish quality of life as well as increase direct and     indirect healthcare costs.      The pathophysiology of osteoporosis is based on two main factors; low bone mass and age     associated architectural changes within the bone, high impact exercise in childhood can     improve the peak bone mass and bone architecture. The evidence suggests that bone adaptation     to increased load is optimal in early puberty (Tanner stages I and II) since around 30% of     total body adult bone mass is accrued during this period.      However, the optimal exercise program for increasing peak bone mineral content is still     unclear. Therefore, the aim of this study is to assess if 15 minutes of high-impact exercise     three times per week improve areal bone mineral density assessed by DXA of pre pubertal girls     after a ten-month regimen compared to low-impact exercise. This information could highly     impact the development of public health policies directed to pre pubertal girls.   "
60924|NCT02488109|"     The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower     calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia     nervosa.   "
60925|NCT02488096|"     The purpose of this study is to determine if using MRI can improve cancer detection by     identifying potential cancer targets prior to TRUS-guided biopsy in populations that have     previous inconclusive results from TRUS-guided biopsies.   "
60926|NCT02488083|"     UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm,     baseline-controlled clinical study for the evaluation of the UltraShape treatment for     non-invasive fat and circumference reduction.   "
60928|NCT02488057|"     This study will examine the benefits of weight loss alone or in combination with a GLP1     receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA)     women with prediabetes. The Investigators have chosen to focus on MA women because MA women     are at very high risk for progression to diabetes and have not traditionally been involved in     weight management studies since they are thought to be difficult to recruit and retain in     such programs. However, investigators have had particular success in working with young MA     women using specifically developed ethnic and gender conscious programs. Because weight loss     does not prevent all progression to diabetes, some participants will receive the diabetes     medication, liraglutide, which has been shown to stabilize beta cell function. The study will     also interrogate for polymorphisms of known T2DM genes to correlate with beta cell response     to weight loss and liraglutide treatment. Additionally, this investigation targets serious     health disparities in metabolic disease in a highly vulnerable, rapidly growing population,     testing novel gender and culturally focused intervention strategies and identifying genetic     biomarkers of response to a pharmacologic intervention that targets the pancreatic ßcell.      These results will help to a) understand mechanisms of disease, b) personalize treatment     through identification of a high risk group that may be amenable to specific therapy, and c)     ultimately, sets the stage for an intervention trial to prevent diabetes, a major chronic and     costly disease, in Mexican Americans.   "
60929|NCT02488044|"     A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the     Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed     to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of     pediatric and adult patients with Arginase I deficiency and hyperargininemia. This study will     be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part 2 (Repeated     Dosing). Each part will be preceded by a baseline assessment of arginine levels. All patients     who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify for continued     dosing. A data safety monitoring board (DSMB) will provide independent review of study safety     data and recommend whether the sponsor should continue the study as planned, modify the study     protocol, or discontinue the study.   "
60930|NCT02488031|"     The purpose of this research study is to investigate how the brain and motor behavior changes     both in individuals with spinocerebellar ataxia and healthy individuals, and to assess     whether a therapeutic intervention reduces levels of uncoordinated movement and improves     motor function in spinocerebellar ataxia (SCA).   "
60931|NCT02488018|"     The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise     the blood glucose level.   "
60944|NCT02487849|"     The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC     with Carboplatin 800 mg/m² KOF (Körperoberfläche) and following platinum-based systemic     chemotherapy should be executed In patients with platinum-sensitive recurrence of ovarian     carcinoma. Condition for HIPEC is attainment of optimal cytoreduction (R0) and experts     judgement of a complication-free prolongation of narcosis after finishing the surgery. HIPEC     will be administered additionally to standard therapy. If HIPEC was executed the number of     systemic given platinum-based chemotherapy decreases for one cycle.      This regime should be investigated in terms of safety of performance, quality of life for the     patients and consequences for the following systemic chemotherapy.   "
60993|NCT02487212|"     The objective of this study is to evaluate the efficacy and safety of using ablative     fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic     scar.   "
60994|NCT02487199|"     This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or     without dasabuvir in adult genotype 1a or genotype 4 hepatitis C infected participants with     severe kidney impairment or end-stage kidney disease.   "
60932|NCT02488005|"     Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free,     low cost measure to assess inflammatory bowel disease (IBD), and is being used as first-line     imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and a     small number of recent studies have looked at change in bowel wall thickness (BWT) in     response to anti-tumor necrosis factor (anti-TNF) therapy. However, the use of SBUS to detect     response to anti-TNF therapy has not been tested in pediatric patients. The purpose of this     study is to apply the use of SBUS to pediatric patients with Crohn's disease and to assess     response to treatment with infliximab. The investigators will also measure C-reactive protein     and fecal calprotectin at baseline, and additionally measuring IFX levels and anti-infliximab     antibodies (ATI) at week 14 to assess change in biochemical response to infliximab treatment,     as well as correlation between these markers with changes in patient reported outcomes via a     weighted pediatric Crohn's disease activity questionnaire (wPCDAI) and changes in BWT. This     study is novel in that it will be the first study in pediatric patients to use SBUS to assess     response to IFX therapy, and will also be the first study to correlate SBUS findings with     therapeutic drug monitoring (TDM). This study has the potential to propagate the use of SBUS     in the pediatric population, as the use of TDM in concert with small bowel imaging     post-induction will allow the investigators to tailor therapy early in the treatment course.   "
60933|NCT02487992|"     The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer     cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for     patients with advanced colorectal cancer.   "
60934|NCT02487979|"     This phase II trial studies how well glembatumumab vedotin works in treating patients with     osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory).     Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill     them.   "
60935|NCT02487966|"     This study explores the effects of mirror therapy and transcranial Direct Current Stimulation     (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be     assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active     tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham     tDCS and sham MT (covered mirror).   "
60937|NCT02487940|"     The study will include 100 women with unexplained recurrent implantation failure undergoing     IVF/ICSI cycle.      Patients fulfilling the inclusion criteria will be randomised into two groups.      Study Group:      This group will include 50 women with unexplained recurrent implantation failure undergoing a     trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day     of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a     final dose 2-3 weeks later when attending for pregnancy scan.      Control Group:      This group will include 50 women with unexplained recurrent implantation failure undergoing a     trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of     oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final     dose 2-3 weeks later when attending for pregnancy scan.   "
60938|NCT02487927|"     To evaluate the distribution of different types of difficult weaning and the predictive value     of weaning relative factors.   "
60953|NCT02487732|"     To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in     type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring     inflammatory markers, circulating number of endothelial progenitor cells, brachial artery     endothelial function, and arterial stiffness.   "
60939|NCT02487914|"     Drug delivery is conducted through various methods such as injection, phonophoresis, and     iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through     epidermis using direct current. The direct current has some disadvantages such as skin     burning and limited time of application. Interferential current is a kind of alternating     currents without limitations of direct current; so the purpose of this study was to     investigate and compare the effects of Lidocaine, interferential current and Lidocaine     iontophoresis using interferential current.   "
60940|NCT02487901|"     Ultrasonic bone osteotome has been utilized in various surgical field, but the use in     neurosurgery especially in spine surgery is not widely spread. In the present study, the     investigators are going to compare bony fusion rate after cervical laminotomy either with     ultrasonic osteotome or conventional drill.   "
60941|NCT02487888|"     The purpose of this study is to evaluate the impact of genetic testing on healthcare     decisions and patient outcomes for patients suffering from pain, cardiovascular problems,     Arthritis, Type II Diabetes, and/or Mental Health disorders. Results of genetic testing will     also be compared with the clinical outcome measures collected to discover novel genetic     factors that may influence patient care.   "
60942|NCT02487875|"     Background: Individuals with COPD may present reduced peripheral muscle strength, which leads     to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength     training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower     extremity muscles' performance are required. Objectives: To assess the muscle strength of     COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum     (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the     responsiveness of STST to a PR program with specific strength training (SPR), compared to     usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included     into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed     before and after PRs.   "
60943|NCT02487862|"     Psychological conditions, particularly psychosocial stress, have been implicated as risk     indicators for periodontal disease. Minimal evidence in literature exists to assess the     effect of stress reduction therapy (SRT) in the outcome of non-surgical periodontal therapy     (NSPT). Hence, the present study was aimed at exploring the possibility of employing SRT in     stressed subjects (assessed using questionnaire data and serum cortisol level) as an     adjunctive intervention in the management of periodontal diseases.   "
60967|NCT02487550|"     The purpose of this study is to show if vaccination with autologous dendritic cells pulsed     with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a     measurable immune response in patients with renal cell carcinoma, and to evaluate the     clinical effect of the regimen.   "
60945|NCT02487836|"     For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on     the endoscopic biliary stent. This technique has been shown to be preferable to a surgical     shunt.      Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized     the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major     way. This design will also be developed in patients with neoadjuvant tumor called     borderline (the limit of the resectability).      However, several conditions (protocol) are required to consider the implementation of this     design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times     the ULN.      In addition, a randomized study showed that preoperative biliary stent treatment, despite a     success rate of 94%, is associated with more complications than surgery fast (related gesture     bladder).      It would be interesting to analyze, prospectively, the fate of a series of patients with     cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1     and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.   "
60946|NCT02487823|"     To determine the maximum-tolerated dose (MTD) of BKM120 when administered orally in     combination with daily bicalutamide and LH-RH agonists to men with non castrate metastatic     prostate cancer.   "
60947|NCT02487810|"     The purpose of this study is to determine whether there are systematic differences between     the decisions patients make intuitively versus deliberatively about life-sustaining medical     therapies.      The targeted population is inpatients at the Hospital of the University of Pennsylvania with     serious medical problems. The study will involve facilitated interviews with patients using a     survey instrument developed in Qualtrics.   "
60948|NCT02487797|"     Oxytocin is a medication that is often used to strengthen contractions to overcome delayed     labor progress. The primary aim of this study is to determine whether receiving a higher dose     of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of     oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and     length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal     Apgar score <5 at 5 minutes, and need for neonatal intensive care.   "
60949|NCT02487784|"     The primary aims of this study are to compare the clinical and histologic results of bone     regeneration with a cancellous block allograft versus MinerOss Cortico cancellous particulate     allograft mixed with autogenous bone chips after 4 months of healing. Titanium reinforced     hd-PTFE (Cytoplast) membrane GBR will be used to cover the bone grafts.      Specific Aim 1: To compare the baseline to 4 month change in clinical ridge width and height.      Specific Aim 2: To compare the histologic percent of vital and nonvital bone and trabecular     space at 4 months.      The primary outcome variable is the change in horizontal ridge width. The secondary outcomes     are the change in ridge height and the percent histologic composition of the augmented site.   "
60950|NCT02487771|"     This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to     follow-up with participants on the original study to determine if the effects of increasing     DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.   "
60951|NCT02487758|"     Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless     Approach to Grafting   "
60954|NCT02487719|"     Examination of iron supplements routinely used in pregnancy to compare these with one another     regarding effectiveness in the prevention of iron deficiency.      Determination of ferritin / hemoglobin every pregnant woman under the first routine check.     Classification into one of three subgroups (group 1: iron sulfate, Group 2: iron polymaltose,     Group 3: multivitamin- multimineral) depending on the measured values. Repetition of     hemoglobin every 8 weeks, at the entrance to birth and postpartum day 1, additional provision     of ferritin at the entrance to birth. In addition, registration of each child's birth weight     and gestational age.   "
60955|NCT02487706|"     Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients     with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from     plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of     HD sessions.   "
60956|NCT02487693|"     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with     ovarian carcinoma.   "
60957|NCT02487680|"     It has previously been shown in healthy overweight subjects, that table water including a     defined amount of amino acids and chromium can decrease the postprandial glucose. In this     study, the effect of this table water on glucose excursions after a test meal containing a     defined amount of available carbohydrates, protein and fat will be studied in healthy     subjects. The study will be conducted in a cross -over design, double blinded and placebo     controlled including 20 participants. The primary endpoint of the study is the incremental     area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the     meal.   "
60958|NCT02487667|"     In adulthood, limited mobility and pain are very common and often the first clear sign of     functional decline. The loss of independent mobility is related to higher rates of functional     disability and mortality; however, it is also susceptible to interventions through exercises.     With aging, changes in peripheral and central nervous system also occur, which lead to     degradation of the sensory receptors as well as a loss of muscle mass and coordination.     However, both, structural and functional dysfunctions of the nervous system, can be mitigated     by increasing physical activity.      The aim of this study is therefore, to study the effects on pain and functional capacity of a     therapeutic exercise training program in an adult people sample. The therapeutic exercise     machines proposed in this trial have not been previously analyzed and provide insight into     this field due to their design. The design of this new machines allows the adaptation to each     concrete clinical situation by the adjustment of different parameters such as feedback, range     of movement, time of repetition, intensity, speed and rhythm, which facilitate motor control     training.   "
60995|NCT02487186|"     The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement     associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized     periodontitis treatment.   "
62113|NCT02472574|"     The purpose of this trial is to determine the optimal dose of rt-PA in the treatment of     intracerebral hemorrhage (ICH) using a combination of minimally invasive surgery and clot     lysis with rt-PA。   "
60959|NCT02487654|"     Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a     patient's quality of life.      Abnormal electrical activity from the 4 veins that drain into the left atrium (top left     chamber of the heart), is the main cause of this condition. Catheter ablation and this     involves making tiny burns within the left atrium that electrically disconnects these veins     form the rest of the left atrium (pulmonary vein isolation). Abnormal electrical activity can     be as a result of the nerves supplying the heart and destroying the collection of these nerve     endings (ganglionic plexi ablation) can be helpful in eliminating the abnormal electrical     activity. Catheter ablation for AF and study the affect of ganglionic plexi ablation on the     success of this treatment option. All patients will be grouped by low or high preexisting     scar. The investigators plan to recruit patients undergoing ablation with proportionate     numbers in both existing scar groups. Patients will be randomly assigned into the two     treatment groups each with different treatment strategies        1. Pulmonary vein isolation alone        2. Ganglionic plexi ablation alone There will be pre and post procedure tests as per          optimal clinical practice. Some patients may require a repeat procedure if they have          documented recurrence. This will be done after a minimum of 6 months. The redo-procedure          will be pulmonary vein isolation for both groups with the ganglionic plexi arm receiving          a lesions encircling the pulmonary veins. This will enable the study to report outcomes          from 3 groups.   "
60960|NCT02487641|"     This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The     hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.   "
60961|NCT02487628|"     The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Soft     Tissue Mesh for the Treatment of Inguinal Hernia. Half of participants will receive HQ®     Matrix Soft Tissue Mesh, while the other half will receive ULTRAPRO® Partially Absorbable     Lightweight Mesh.   "
60962|NCT02487615|"     Subclinical atherosclerosis is the atherosclerotic process identified before clinical     symptoms and thus it can be a useful marker of future cardiovascular events. It can be     evaluated by many methods. This study included the diagnosis of subclincal atherosclerosis by     four different methods: coronary calcium score, carotid doppler ultrasound to quantify intima     media thickness and carotid plaques, exercise stress test and ankle brachial index. Clinical     data, anthropometric measures (body mass index, abdominal circumference), markers of     inflammation (high sensitive - C reactive protein, TNF alfa and Lipoprotein Associated     Phospholipase A2), fat tissue function (leptin, resistin and adiponectin), glucose metabolism     (fasting plasma glucose, glycated hemoglobin and insulin) and genetics markers of     atherosclerotic process were evaluated as biomarkers of subclinical atherosclerosis in a     uneventful population.   "
60963|NCT02487602|"     The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight loss     device in vivo to further understand the device's mechanism of action in aiding weight loss.   "
60976|NCT02487433|"     This study will evaluate the drug behavior and safety of a single dose of the 22 milligram     tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken     after eating a high fat meal (the effect of food). This will be compared to the drug behavior     and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release     formulation when taken after a 10 hour fast.   "
61117|NCT02485587|"     The purpose of this study is to determine whether individualized biofeedback of arousal (skin     conductance) is effective in the treatment of aggressive behavior problems in children and     adolescents with either predominantly impulsive (reactive) and/or high callous unemotional     traits (proactive) subtypes of aggression when compared to treatment as usual (TAU), and     induces normalization when compared to a group of typically developing children receiving no     intervention.   "
60964|NCT02487589|"     Fall incidents are the third cause of chronic disablement in elderly according to the World     Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk     assessment and management programs are effective in all older population studied. However,     the application of these programs may not be the same in all National health care setting     and, consequently, needs to be evacuated by cost-effectiveness studies before to plan this     intervention in regular care. In Italy structured collaboration between hospital staff and     primary care is generally lacking and the role of Information and Communication Technologies     (ICT) in a fall prevention program at home has never been explored.      This is a two-group randomized controlled trial aiming to evaluate the effect of a home-based     intervention program, delivered by a multidisciplinary health team, in preventing falls in     elderly. The home tele-management program, previously adopted in our Institute for chronic     patients, will be proposed to elderly people affected by chronic diseases at high risk of     falling at time of hospital discharge. The program will involve the hospital staff and will     be managed thanks to the collaboration between hospital and primary care setting. Patients     will be followed at home for 6 months after hospital discharge. A nurse-tutor will be the     case manager and telephone support, telemonitoring and tele-exercise will characterize the     intervention program. People in the control group will receive the usual care. The main     outcome measure of the study will be the percentage of patients sustaining a fall during the     6-months follow-up period. An economic evaluation will be performed from a societal     perspective and will involve calculating cost-effectiveness and cost utility ratios.   "
60965|NCT02487576|"     This human dietary intervention study with a cross-over design aims to investigate the effect     of two different diurnal patterns of meal composition on peripheral circadian clocks and     energy metabolism in healthy men.   "
60966|NCT02487563|"     Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to     an increased risk of life-threatening hemorrhage, frequent requirement of platelet     transfusions and extended hospital stays, representing a challenging clinical problem.     Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet     recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent     to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT.     Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce     platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted     an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine     in the treatment of thrombocytopenia following HSCT.   "
60969|NCT02487524|"     Investigators aim to identify the key phenotypes (biological, psychological, genetic)     involved in the transition from acute to chronic neuropathic pain (NP) by comparison of the     neuropathic pain phenotypes and genomics of patients developing NP or not under similar nerve     injury conditions. The cohort is part of a previous prospective study of 1000 patients     operated for breast cancer of whom 350 have surgeon defined intercostobrachial nerve     resection during operation with or without persistent pain and additional 50 patients with     pain, but no nerve resection during operation. Patients fill in questionnaires and a detailed     sensory examination, cognitive tests, and a cold water test with autonomic nervous system     monitoring are performed during the research visit. A selected group of patients undergo     quantitative sensory testing (QST).   "
60970|NCT02487511|"     It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP),     7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one     PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7     or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.      This study aims to investigate which duration would be better for eradication of HP. The     study design is a randomized controlled trial. The patients were randomly assigned to 7 days     or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple     therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in     both groups.   "
60971|NCT02487498|"     The purpose of this study is to demonstrate that the efficacy of the combination product     QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a     pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.   "
60972|NCT02487485|"     The aim of the study is to provide insight into the impact of the immunosuppressant drug     sirolimus, on the antidepressant effects of the prototypal rapid-acting antidepressant     medication, ketamine.   "
60973|NCT02487472|"     The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic     neuralgia (PHN) among people ≥ 50 years old in France, in terms of healthcare resources used,     medical direct and indirect costs, as well as pain severity and impact on quality of life.   "
60974|NCT02487459|"     This is an open-label, non-randomized study to evaluate the safety of two planned infusions     of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with     hematologic malignancies.   "
60975|NCT02487446|"     The purpose of this study is to demonstrate that the efficacy of the combination product     QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a     pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.   "
61000|NCT02487121|"     This project examines the effects of differing schedules of extended care contact following     weight loss treatment in order to prevent weight regain following treatment.   "
60977|NCT02487420|"     1. The investigators here want to test the hypothesis that a total period of 18 months of          gradual open introduction of a certain egg product with regard to full egg tolerance          induction is not inferior when compared to a total period of 30 months gradual open          introduction of a certain egg product (see steps for the specific egg products) after          tolerance for baked egg has been obtained.        2. The investigators also want to define step-specific 'tolerance-failures' and study the          relevance of specific IgE to specific egg components to predict failures at each step.   "
60978|NCT02487407|"     In the double-blind, cross-over part of the study, ODM-109 capsules and placebo capsules for     ODM-109 will be administered for 2 weeks separated by a 19-23 days wash-out period. During     each treatment period of the double-blind cross-over part, there will be a baseline visit     (day 1) and 2 visits (5 ± 2 and 14 ± 2 days) after the start of study treatment. After     completing the 3rd treatment period, the subjects will continue in the open-label follow-up     part for 6 months. During the open-label follow-up, visits will be at 1, 3 and 6 months. An     end-of-study visit will take place 14-25 days after the last study treatment administration     for each subject. The study duration will be about 13-14 weeks for the double-blind     cross-over part, and about 9-10 months for the entire study including the 6 months open-label     follow-up.      The number of randomised study subjects is planned to be approximately 54 in cross-over     comparison. The maximum number of subjects will not exceed 70.      Primary objective is to investigate the efficacy of oral ODM-109 on respiratory function in     patients with amyotrophic lateral sclerosis (ALS).   "
60979|NCT02487394|"     The purpose of the study is to better understand the function of asthma and COPD, and     response to therapy. There are two Phases to this study broken into two arms. In Phase I, our     propose is to use discovery proteins and techniques to identify protein expression     signatures. In Phase II, is to establish and validate the predictive value of protein     signatures for treatment responses using inhaled corticosteroids.   "
60980|NCT02487381|"     The study evaluates the gene-environment interaction of the COMT-genotype on the effects of     the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on     induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal     processing, and neural oscillations. In addition the effects of the phytocannabinoids on     lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal     processing assessed by EEG and fMRI.   "
60981|NCT02487368|"     The needle stimulation pad is a self-care device, which has been promoted for pain control     and well-being. The aim of the study was to test the efficacy of the pad for     chronic/recurrent low back pain treatment.      Patients with non-specific chronic or recurrent low back pain were selected from a large     health insurance company database and advised to use the pad daily for two weeks; outcomes     were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week     2; secondary outcome measures included the Oswestry disability index (ODI), health-related     quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic     medication consumption and safety.   "
60982|NCT02487355|"     The study will conduct to compare the efficacy of Magnesium sulphate & dexmedetomidine used     as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as     post -operative analgesia in pediatric patients.   "
60983|NCT02487342|"     Comprising two experiments, the investigators assessed the metabolic, endocrine and     appetite-related responses to acute (1-d, part 1) and daily mid-morning milk consumption     (28-d, part 2) in adolescent males (15-18 y).   "
60984|NCT02487329|"     The purpose of this randomized clinical study was to evaluate the efficiency of Er,Cr:YSGG     laser irradiation combined with a resin based tricalcium silicate material and calcium     hydroxide (CH) in direct pulp capping for 3 months follow-up period.Sixty permanent vital     teeth without symptoms and radiographic changes were randomly assigned to 4 groups (n=15): Gr     1: The exposed area was sealed with CH paste, Gr 2: The treated area was sealed with CH paste     following Er,Cr:YSGG laser irradiation at an energy level of 0,5 W without water and 45% air,     Gr 3: Resin based tricalcium silicate material (TheraCal LC) was applied directly to the     exposed pulp, Gr 4: TheraCal LC was applied following irradiation with Er,Cr:YSGG laser.   "
60985|NCT02487316|"     The purpose of this study is to determine the efficacy and safety of crizotinib combined with     CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.   "
60986|NCT02487303|"     This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative     pain after scheduled, elective Cesarean delivery. All patients will receive a standardized     spinal anesthetic for operative anesthesia and will be randomized into one of three groups:     (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral     acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a     randomized, open label study.   "
60987|NCT02487290|"     The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to     treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac     following an EVAR procedure.   "
60988|NCT02487277|"     We will be conducting a Phase II study investigating PEGPH20 in combination with gemcitabine     and nab-paclitaxel in patients with borderline resectable PDAC at the Helen Diller Family     Comprehensive Cancer Center at UCSF. There are multiple definitions of borderline resectable     PDAC including the MD Anderson definition and the criteria developed during the Consensus     Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of     Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable     PDAC cases will be identified per the definition developed in the currently running     inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this     trial, borderline resectable PDAC is defined as presence of any one or more of the following     on CT:        -  An interface between the primary tumor and the superior mesenteric vein or portal vein          (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall        -  Short-segment occlusion of the SMV-PV with normal vein above and below the level of          obstruction that is amenable to resection and venous reconstruction        -  Short segment interface (of any degree) between tumor and hepatic artery with normal          artery proximal and distal to the interface that is amenable to resection and          reconstruction.        -  An interface between the tumor, and SMA measuring < 180º of the circumference of the          vessel wall.      This trial will be conducted in two parts. In Part I, pre-treatment EUS-guided core biopsies     of the pancreatic tumor, CA 19-9 levels and functional MRIs including DCE-MRI and DWI-MRI     will be obtained for the first fifteen patients enrolled. After a 1-week run-in period with     PEGPH20 on days 1 and 4, patients will have repeat EUS-guided core biopsies, functional MRI,     CA 19-9 level and baseline CT chest, abdomen and pelvis. Subsequently, patients will be     started on treatment with PEGPH20, gemcitabine and nab-paclitaxel given weekly for 3 weeks,     every 28 days. To evaluate the disease response to treatment, CA 19-9 levels will be checked     monthly and restaging CT chest, abdomen and pelvis will be obtained every 8 weeks. If there     is disease progression at any point in the study, patients will be taken off of study and     alternative treatments will be offered. At the completion of 4 cycles of therapy, restaging     CT scans will be obtained to determine resectability. If the patients are found to have     resectable disease, an additional functional MRI will be obtained to evaluate the PDAC     stroma. If the patients are able to have successful surgeries, tissue analyses will be     performed on the resected pancreatic tumor. These patients will then proceed to get 2 cycles     of adjuvant chemotherapy with gemcitabine and nab-paclitaxel. If the patients are deemed to     be surgical candidates but are found to have unresectable disease in the operating room, an     intraoperative core biopsy of the pancreatic tumor will be obtained for tissue analyses. At     the time of initiation of therapy with PEGPH20, patients will be started on prophylactic dose     of enoxaparin 1 mg/kg subcutaneous daily. This will be continued throughout the study     participation.      In Part II, an additional 21 patients will be enrolled, and will begin neoadjuvant therapy     with PEGPH20, gemcitabine and nab-paclitaxel without the 1 week run-in of PEGPH20-only or the     pre- and post-run-in EUS-guided biopsies.   "
60989|NCT02487264|"     A retrospective analysis of all patient presenting with multiple rib fractures to the     emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics,     cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain     levels and treatment, and sequelae will be recorded and analyzed.   "
61001|NCT02487108|"     The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone     bitartrate/acetaminophen immediate-release tablets at doses of 5.0 mg/325 mg, 7.5 mg/325 mg,     and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating patients with moderate     to severe pain following bunionectomy   "
61028|NCT02486757|"     Irregular menstrual cycles are common in girls for several years after their first menstrual     period. The cause of abnormal menstrual cycles during this time is not well-understood. The     purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine     sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release     of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls     with a short course of low-dose estrogen and progesterone.   "
67302|NCT02404792|"     The primary objective of this proposal is to compare a moderate or high intensity exercise     intervention to improve physical function in persons aging with Human Immunodeficiency Virus     (HIV).   "
60990|NCT02487251|"     Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times     higher risk for obesity compared to middle- to upper-income children. Obesity interventions     have turned toward the promotion of family mealtimes. Many families report barriers to     regular mealtimes but barriers in low-income families are intensified. While most prevention     efforts focus solely on nutrition education and knowledge, this project's approach is built     on the premises that: 1) enhancing parents' abilities to implement healthy family mealtimes     is critical to effective obesity prevention; and 2) inconsistent implementation of family     meals is not due only to a lack of nutrition education or knowledge, but to the adverse     effects of poverty on parents' capabilities to plan and execute mealtime. The investigators     propose to test the main, additive and interactive effects of 6 intervention components     reflecting differing levels of supports to increase the frequency of healthy family mealtimes     and ultimately reduce childhood obesity prevalence. The investigators will test 6     intervention components in a Screening Phase (N = 520), resulting in the implementation and     evaluation of a final intervention model in the Confirming (N = 250) reflecting the most     effective intervention components tested in the Screening Phase. The investigators     hypothesize that providing low-income families with effective supports to enhance family     capability to plan and implement family mealtimes will lead to increased frequency of     mealtimes and to improvements in children's dietary quality and adiposity indices. Results     will inform policy (e.g. where limited resources may be allocated for maximum benefit) and     Extension efforts (e.g. supports most effective in promoting family meals).   "
60991|NCT02487238|"     The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbial     transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory     bowel disease-unclassified (IBD-U). Investigators will test the hypothesis that a protocol of     twice-weekly retention enemas delivered over six weeks, using fecal transplant material from     a healthy donor, will improve clinical and biological disease markers in patients with     pediatric UC or IBD-U.   "
60992|NCT02487225|"     This is a single center randomized, double-blind, placebo-controlled study, to be conducted     at Mayo Clinic, Rochester, MN.      The objective of our research is to determine whether inhibition of the tumor necrosis     factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and     whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The     study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the     drug or a placebo, which looks like the drug, for a period of 3 days or until the time they     are discharged, if hospital discharge is within 7 days of admission. The levels of markers of     inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and     Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or     until the time of discharge, whichever occurs earlier.      Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours     of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1)     amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic     cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take     place 24 hours of admission.      Determination of group size was based on the previous pilot study to decrease any of the     important adverse outcomes, providing for a dropout rate of 10% during the study. During     2012, 263 patients with AP were admitted to this institution, which possesses the needed     infrastructure for successful completion of clinical drug intervention trials.   "
60996|NCT02487173|"     The primary purpose of this study is to validate the sensitivity and specificity of the     Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold     standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).      The secondary aims are to:        -  validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza          B , when used by subjects, as compared to the gold standard for detection, Reverse          Transcriptase Polymerase Chain Reaction (RT-PCR).        -  assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza          A+B Test in detecting Influenza A;        -  assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza          A+B Test in detecting Influenza B;        -  evaluate the correct interpretation of the Respirio Flu Test results by subjects with          Influenza-like illness symptoms;        -  evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the          Respirio Flu Test;        -  evaluate the subjects' comprehension of the Respirio Flu Test labelling; and        -  establish the minimum sample weight required to achieve a result with the Respirio Flu          Test.   "
60998|NCT02487147|"     This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR)     system versus a N95 mask in preventing nasal detection of influenza following an exposure.     The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95     respirator at interrupting the exposure of the study participants to aerosolized influenza     virus particles.   "
60999|NCT02487134|"     Patients with at least two risk factors for incisional hernia undergoing abdominal surgery     are eligible for inclusion. After accepting informed consent, patients are randomized into     either closing the abdominal wall in a regular way with fascial sutures, or closing with     fascial sutures together with placing a TIGR mesh as described. All patients are then     monitored for signs of infection, wound rupture, incisional hernias, subcutaneous seroma as     well as postoperative symptoms. All patients will be followed for at least 5 years. One year     postoperatively, a computer scan is performed to detect asymptomatic incisional hernias.   "
61002|NCT02487095|"     Background:      Chemotherapy damages cancer cell DNA so the cells die and the tumor shrinks. But it may stop     working in some people over time. This is partly due to efficient DNA damage repair     mechanisms used by tumor cells. VX-970 may stop cancer cells from preventing the repair of     DNA damaged by chemotherapy. The purpose of this study is to see if using the chemotherapy     drug topotecan along with the drug VX-970 will improve the response to chemotherapy.      Objective:      To study the safety and efficacy of VX-970 and topotecan in treating small cell lung cancer.      Eligibility:      Adults at least 18 years old with small cell lung cancer .      Design:      Participants will be screened with medical history, physical exam, blood and heart tests, and     scans. Most of these tests are part of their routine care. Most of these tests will be     repeated throughout the study.      The study is set in 21-day cycles. Participants will get topotecan IV on days 1 through 5.     They will get VX-970 IV on day 5 alone or on day 5 and day 2.      Participants doctors will monitor them weekly for the first cycle, every 3 weeks after that.      For Part 1 of this Study the doses of topotecan and VX-970 will be increased (according to     the Protocol) to determine the maximum safe dose of the combination. The maximum safe dose of     the combination is the dose at which no more than 1 in 6 people have an intolerable side     effect.      More participants will join in Phase 2. They will take the drugs at the maximum safe dose, on     the same schedule as the drugs were taken in Phase 1.      Participants will give samples of blood, hair, and tumor tissue (optional) at different     times. They will discuss side effects at every visit.      A month after stopping taking the drugs, participants will have a physical exam and blood     drawn. They will have follow-up phone calls every 3 months.   "
61003|NCT02487082|"     The purpose of this study is to test the combined effect of melatonin and donepezil on     improving sleep and behavior in children with Autism Spectrum Disorders. Melatonin is a     natural neurohormone that helps regulate sleep and wake cycles. Donepezil is used to improve     mental function for people with Alzheimer's disease. Children with Autism Spectrum Disorders     are more likely to have problems sleeping than other children. This difficulty has been     linked to daytime behavioral problems and family stress.   "
61004|NCT02487069|"     The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell     transplantation (allo-HSCT) from sibling matched donor (SMD),matched unrelated donor (MURD)     and haploidentical related donors(HRD) in the treatment of hematologic malignancy.   "
61005|NCT02487056|"     The purpose of this study is to compose a national database of the etiologies, clinical and     demographic characteristics, using diagnostic tests, precipitating and risk factors,     management of from intensive care unit or coronary care unit to hospital discharge, length of     stay in the intensive care unit and hospital, in-hospital mortality and discharge medications     of hospitalized acute heart failure patients in Turkish population.   "
61006|NCT02487043|"     Despite improvements in oral health among children, children living in areas characterized by     low socio-economic status still have a significant disease burden with regard to dental     caries. Special efforts to prevent disease development in this group of children have been     unsuccessful. Small children with extensive treatment needs often have limited abilities to     cooperate and to provide quality dental care in this patient group, general aneaethesia (GA)     may often be the treatment modality of choice. Preschool children treated under general     anesthesia have significantly higher caries prevalence (deft and defs), apical parodontitis     and infection due to pulpal necrosis. They also have significantly more emergency visits and     previous use of treatment under sedation.      This study aim to test the hypothesis, that a telephone based case management intervention     for children with severe early childhood caries can prevent further caries development in     preschool children who are treated under general anesthesia for severe early childhood     caries.   "
61007|NCT02487030|"     This study will evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir     (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults     with chronic genotype 4 hepatitis C virus (HCV) infection.   "
61008|NCT02487017|"     Evaluation of DC-CIK cells combined TACE treatment for HCC   "
61009|NCT02487004|"     The purpose of this study is to determine whether the change of serum and dialysate sodium     level during hemodialysis can influence on blood pressure and intradialytic weight gain in     chronic hemodialysis patients.   "
61019|NCT02486874|"     PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine,     Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a     permanent dermal substitute aiming to reduce skin contracture. The objective of this study is     to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.   "
61158|NCT02485054|"     The transient visual disturbances (TVD) are defined by a short abnormality of visual     function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic     origin.      The difficulty is to recognize an ischemic mechanism which imposes emergency cares.      A clinical score could help the clinician to recognize the etiology of the TVD .   "
61010|NCT02486991|"     Thirty patients will be treated: 15 with a coronally positioned tunnel technique plus     intramucosal verticals with AlloDerm® (test treatment) and 15 with a coronally positioned     tunnel technique alone with AlloDerm® (control treatment). The surgical procedure for the     control sites will consist of a coronally positioned tunnel preparation that is a     modification of a previous tunnel technique described by Allen AL (Allen AL, 1994a/1994b).     This tunnel technique was modified to include coronal positioning of the soft tissue over an     allograft (E.P Allen). The surgical procedure for the test sites will consist of a coronally     positioned tunnel preparation (E.P. Allen) plus the use of mesial and/or distal intramucosal     verticals, a modification of the vestibular incision subperiosteal tunnel access (VISTA)     approach (Zadeh H, 2011). Each patient will provide at least one Miller Class I or II facial     recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either     the test or control treatment. Three exams for measurements will be performed per patient on     total: preoperative, at week eight and 16 (4 months) postoperatively. The primary aim is to     compare the percent root coverage obtained with acellular dermal matrix using the coronally     positioned tunnel technique alone or with intramucosal verticals.   "
61011|NCT02486978|"     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak     concentration usually after 30 minutes. When the body senses the increase in blood glucose, a     hormonal process involving insulin takes place to ensure that the glucose is taken up from     the blood for storage and where it is needed for energy in the body. This process then brings     about a decrease in the concentration of glucose until it reaches approximately the starting     concentration. The original concentration of glucose is attained approximately 2 hours after     eating or drinking a carbohydrate food or sugary drink respectively in healthy people.      Different carbohydrates and sugary drinks have different effects on blood glucose response     depending on the amount as well as the type of carbohydrate. Those that give rise to a high     glucose response compared to a reference carbohydrate (usually glucose) are said to be high     glycaemic index (GI) foods and those with a lower glucose response compared to a reference     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.      Research has shown that diets that give rise to a high glucose response are associated with a     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly     comprises of insulin resistance and glucose intolerance which gives an increased risk of type     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)     rather than rapidly (high GI) have health benefits which include reducing the risk of     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can     lower the blood glucose levels.      This research will determine whether the presence of polyphenols in the diet has any lowering     effect on the blood glucose levels and hence the glycaemic index of foods. This will be     determined by asking volunteers to consume commercially available food supplements together     with white bread and then determining the glycaemic response. The blood glucose response of     bread will be determined initially as a control reference. All will be consumed in random     order.      Analysis will be done by measuring blood glucose response after consumption of the control     reference meal and the test meal containing polyphenols and then determining the incremental     area under the glucose curve.      POMEGRANATE AND OLIVE STUDIES WILL BE TREATED SEPARATELY FOR PURPOSES OF PUBLISHING RESULTS.     EACH STUDY WILL AIM TO HAVE AT LEAST 16 PARTICIPANTS.   "
61012|NCT02486965|"     Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of     widespread pain in all four quadrants of the body. Currently, there is no causal treatment of     fibromyalgia syndrome.      The aim of this study is the evaluation of a specific training program on controls of pain in     fibromyalgia patients by balancing the stress axis.      The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured     during the test of the thermode (difference between the average VAS measured between the 10th     and 40th second of P1 and the average VAS measured between the 10th and 40th of the second     P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will     be compared in the two groups..Salivary cortisol is also tested.   "
61013|NCT02486952|"     Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in     combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL).     Participants, who were not treated previously for DLBCL, will receive MabThera in combination     with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like     chemotherapy according to registered indication. Patients will be followed up for safety and     efficacy evaluation in accordance with routine practice. The study will be non-interventional     and by its design purely observational. All treatments prescribed during the observation     period will be at the treating physician's discretion and will be prescribed according to     package labeling, within approved indication and local approval status of respective drugs.   "
61014|NCT02486939|"     An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and     durability of response of subjects who completed 48 weeks of evaluations in the confirmatory     safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with     rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.   "
61015|NCT02486926|"     Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating     airway properties, rapid induction and emergence. However, it is associated with emergence     agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a     cause of stress to both caregivers and families. Various pharmacologic agents have been     suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This     study was designed to compare the effects of remifentanil and remifentanil combining     alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.   "
61016|NCT02486913|"     The investigators will develop a risk report within the primary care electronic health     record (EMIS) for patients attending for their National Health Service Health Check. The     value of the report for reducing cardiovascular risk will be assessed qualitatively and also     quantitatively in a non-randomised comparative trial.   "
61017|NCT02486900|"     The study aims to examine whether the neurofeedback method (based on functional magnetic     resonance imaging [fMRI]) can help patients with alcohol dependence to control their urges to     drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on abstinence     and drinking behaviour will be evaluated based on the comparison between a group of patients     receiving multiple sessions of neurofeedback training and a group of patients receiving     treatment as usual over the same period of time.   "
61018|NCT02486887|"     The main objective of the study is to evaluate the effect of telemonitoring on mortality and     rehospitalization due to heart failure on patients with chronic heart failure which have     follow an educational program compared to a conventional follow-up during 1 year.      The secondary objectives of the study are :        -  Evaluate the cost of health        -  Qualitatively evaluate telemonitoring on uses        -  Evaluate quality of life   "
62115|NCT02472548|"     Administration of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory     Syncytial Virus (RSV) SHe antigen and DepoVaxTM adjuvant to healthy adults ≥50-64 years of     age.   "
61020|NCT02486861|"     The OCT-FORMIDABLE register will include with a retrospective fashion all consecutive     patients that perform OCT on culprit and not culprit plaque in any subset in patients with     ACS. Clinical and OCT data will be included in the register according to the dataset.The     primary endpoint will be the correlation of OCT characteristics with incidence of major     adverse cardiovascular events (MACEs defined as the composite of death from cardiac causes,     non- fatal MI, clinically driven target vessel revascularization (TVR), or re-hospitalization     due to unstable or progressive angina according to Braunwald Unstable Angina Classification)     and clinical baseline characteristics.      In particular subanalysis will be performed in the following subgroups: culprit plaque, not     culprit plaque in culprit vessel, not culprit plaque in different vessel.      Secondary end-point will be to evaluate how OCT analysis changed interventional cardiology     approach in culprit plaque definition and coronary stenting respect the coronary angiography     alone.   "
61021|NCT02486848|"     5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female     pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in     the overall population is relatively low i.e., 30-40% re-grow hair.      The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage     (15%) will increase the number of responders among female subjects that have been identified     through IVD testing as non-responders to 5% topical minoxidil.   "
61022|NCT02486835|"     Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm     cough spells without sedating the reflex. The intent of this study is to use a protective     syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and     safety versus placebo in children with moderate to severe night and daily cough. Cough is     assessed with a validated parent questionnaire. The degree of disturbance of cough is     followed immediately after one night administration of the study products and daily for 4     nights, 3 days.   "
61023|NCT02486822|"     This study aims to compare the novel labour scale with the traditional WHO partograph in the     management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes   "
61024|NCT02486809|"     This study will assess the bioequivalence in healthy participants between a     high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a     single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab     administered SC as a single injection via PFS-NSD.   "
61029|NCT02486744|"     This will be a prospective observational study of Acthar Gel in Non-Diabetic Hemodialysis     [NDHD] patients receiving dialysis for ≤ 2 years. The project will aimed at providing     proof-of-concept data that 80 U two times [2x] week Acthar for 6 months is a safe and     effective therapy for NDHD. Effectiveness of lower dose 40 U 2X week will also be determined.     Therefore the study will be a repeated measures design (Time x condition) comparison of     improvement in renal function, nutritional status, quality of life and physical performance     resulting from Acthar therapy.   "
61030|NCT02486731|"     Noonan and LEOPARD syndromes share, with variable severity, different clinical traits,     notably craniofacial manifestations, cardiopathies, short stature, and juvenile cancers.      The main genetic cause of these syndromes is missense mutation of the gene encoding the     ubiquitous tyrosine phosphatase Shp2, found in more than half the patients with NS and in 80%     of LS cases. Shp2 plays pivotal roles in development, growth, and metabolism by regulating     key signalling pathways (Ras/Mitogen activated protein kinase (MAPK), Phosphoinositide-3     Kinases (PI3K)/Akt) in response to growth factors/hormones. Deregulation of these signalling     pathways has been causally linked to NS and LS pathophysiology.      This project aims at better understanding hormonal sensitivity abnormalities in patients with     Noonan syndrome (NS) or LEOPARD syndrome (LS) caused by mutations of the tyrosine phosphatase     Shp2.      To reach this goal, the investigators will take advantage of different tissues (fibroblasts ±     adipocytes) from patients with NS / LS compared to healthy controls.      All patients will have a skin biopsy and only patients about to undergo surgery will have a     adipose tissue biopsy.   "
61031|NCT02486718|"     This is a Phase III, global, multicenter, open-label, randomized study to compare the     efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A)     treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA     non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured     by disease-free survival (DFS) as assessed by the investigator and overall survival (OS).     Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will     be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.   "
61032|NCT02486705|"     The proposed pilot study is designed to test the feasibility, acceptability, and potential     effectiveness of a mobile phone application (app) developed by the VA National Center for     PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder     (PTSD). The primary objective of the proposed study is to assess whether family members of     veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use.     Secondary objectives are to determine if use of the app increases family members'     self-efficacy and their ability to manage their own life stress, which may in part be the     result of living with someone who has PTSD.   "
61033|NCT02486692|"     The purpose of this study is to evaluate the AboutFace peer education website for the purpose     of reducing stigma and improving attitudes toward seeking mental health services among     Veterans.   "
61034|NCT02486679|"     A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley     catheter for cervical ripening.   "
61048|NCT02486497|"     Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a     predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it as     an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to     investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen     between gemcitabine and 5-fluorouracil (5-FU).   "
61159|NCT02485041|"     Healthy male volunteers were administered alone and in combination with dapoxetine 30mg     mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was     compared between the two drugs.   "
61160|NCT02485028|"     Healthy male volunteers were administered alone and in combination with dapoxetine 30mg     mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was     compared between the two drugs.   "
61035|NCT02486666|"     Background Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the     treatment of neonatal thrombosis that is monitored with anti-factor Xa (anti-Xa) levels.     However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult     studies. The burden of pain to neonates due to venipunctures and of resources to the health     care system also warrants a evidence-based review to assess the utility of monitoring LMWH     therapy with anti-Xa levels. Here the investigators describe the FiXET trial.      Methods/Design This is a prospective pilot, feasibility and safety multicenter, randomized     controlled trial to compare the approach of treating thrombosis in neonates with enoxaparin     using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined     anti-Xa range (0.5-1.0 u/mL). The investigators plan to recruit 20 neonates over a 6 month     period, who will be randomized prior to their first anti-Xa level being resulted. Key     feasibility outcomes include screening/:recruitment ratio, monthly recruitment rate, and     completeness of data collection. The investigators will also measure the safety outcome of     bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome.      Discussion The administration of weight adjusted fixed dose of enoxaparin without anti-Xa     monitoring has the potential to reduce pain from multiple venipunctures in neonates as well     as resources used in their already complex care. The results of the FiXET trial will set the     framework for a larger multicenter randomized controlled trial to compare the efficacy of     administering enoxaparin to neonates without monitoring to the current conventional approach     of routine monitoring with anti-Xa levels.   "
61036|NCT02486653|"     The purpose of this study is to determine if tamsulosin (FLOMAX) is effective in preventing     post-operative urinary retention following abdominal surgery. Post-operative urinary     retention is a common post-operative complication, occurring in up to 30% of patients     undergoing abdominal surgery. It can be described as the inability to initiate urination or     properly empty one's bladder following surgery. It is usually self-limited, but it requires     the use of catheterization to empty the bladder in order to prevent further injury to the     bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication     that is commonly used in men with urinary symptoms related to an enlarged prostate. There is     some evidence to suggest that it may also potentially be beneficial for preventing     post-operative urinary retention. Therefore, in this research study, subjects scheduled for     abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo     once-daily for one week leading up to surgery, and up to several days after surgery. Urinary     function will be assessed and compared between these two treatments. The hypothesis is that     tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.   "
61037|NCT02486640|"     This study aims to evaluate potential predictors of adherence by investigating a     representative cohort of MS patients in Germany treated with Betaferon   "
61038|NCT02486627|"     This is a randomized, multicenter, multinational, double-blind study comparing the efficacy     and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in     the treatment of cUTI, including AP, in adults.   "
61884|NCT02475590|"     Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass     (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary     outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.   "
61040|NCT02486601|"     This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist     in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown     University Phase I study.      In neoadjuvant setting : 3 months of treatment      Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable     toxicity, or patient decision.      Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the     result of the neo-adjuvant treatment and the ability of patients to receive adjuvant     chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative     condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less     than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and     post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks     post-operatively.   "
61041|NCT02486588|"     In collaboration with Vitality/Discovery in South Africa, an RCT amongst adult enrolled in     the lowest tier of Vitality's HealthyFood benefit will be conducted. We will compare the     effect of various messaging, and financial incentive strategies on healthy food purchasing     behaviors in this population.   "
61042|NCT02486575|"     More than 50 residents in surgical specialities (OB&G, General surgery and Urology) from a     single university in Italy will be randomized into two groups, after a stratification based     on residency year and laparoscopic/simulator experience. The first one will train to FLS     (fundamentals of laparoscopic surgery) following pre-recorded instruction from course     materials; the second one will be mentored by a proctor in single training section. The aim     is to evaluate the best way to train residents applying for the very first time in an     extensive way the fundamentals of laparoscopic surgery program in an Italian Institution.   "
61043|NCT02486562|"     iConquerMS™ is a research initiative developed by and for people with multiple sclerosis (MS)     to contribute their health data and ideas to advance and accelerate research into MS.   "
61044|NCT02486549|"     The purpose of this study is to compare the supraclavicular block to interscalene block in     patients undergoing arthroscopic shoulder surgery.   "
61045|NCT02486536|"     The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in     patients referred for CE examination.   "
61046|NCT02486523|"     The objective of the research is to assess the effectiveness of adding a Household WASH     component to the standard outpatient treatment of severe acute malnutrition.      Study design: cluster-randomized controlled trial comparing two interventions:        1. Control group: outpatient management of children diagnosed for severe acute malnutrition          only        2. Intervention group: outpatient management of children diagnosed for severe acute          malnutrition + household WASH package      2000 children, aged between 6 and 59 months, admitted to 20 OTP (Outpatient Therapeutic     Program) centers for SAM will be included into the study and followed for 8 months (2 months     of treatment, and 6 months after successful discharge).   "
61047|NCT02486510|"     Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy     and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and     controlled clinical trial.   "
61049|NCT02486484|"     Background/aims: Aflibercept is an approved therapy for neovascular macular degeneration     (AMD), diabetic macular edema (DME), retinal vein occlusion and other retinal conditions.     Ziv-aflibercept is also approved by FDA and is extremely cost-effective relative to the     expensive same molecule aflibercept. In vitro and in vivo studies did not detect toxicity to     the retinal pigment epithelium cells using the approved cancer protein, ziv-aflibercept.     Ziv-aflibercept had no loss of anti-VEGF activity when kept at 4°C in polycarbonate syringes     over 4 weeks. Similar to bevacizumab, compounded ziv-aflibercept would yield a tremendous     saving compared to aflibercept or ranibizumab. Phase I studies and case reports did not     report any untoward toxic effects but attested to the clinical efficacy of the medication.     Our purpose is to ascertain the long-term safety and efficacy in various retinal diseases of     intravitreal ziv-aflibercept.      Methods: Prospectively, consecutive patients with retinal disease that require aflibercept     (AMD, DME, RVO, and others) will undergo instead the same molecule ziv-aflibercept     intravitreal injection of 0.05 ml of fresh filtered ziv-aflibercept (1.25mg). Monitoring of     best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal     structure by spectral domain OCT to be done initially, one month, 6 months, 1 year, and 2     years after injections.      Anticipated Results: Analyze signs of retinal toxicity, intraocular inflammation, or change     in lens status, together with best corrected visual acuity and central foveal thickness at 1     month, 6 months, 1 year and 2 year. Anticipated Conclusions: Off label use of ziv-aflibercept     improves visual acuity without ocular toxicity and offers a cheaper alternative to the same     molecule aflibercept (or lucentis), especially in the third world similar to bevacizumab.   "
61050|NCT02486471|"     Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To     avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical     Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary     outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient     and influence of Independent factors such as Age and Body mass index.   "
61066|NCT02486263|"     The overall purpose of the investigator's study is to evaluate the causes of and treatment     for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New     treatments can be possible only if the cause is known. Many infants have GERD and feeding     difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the     stomach. Some of these infants have difficulty in protecting their airway during feeding or     during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most     GERD treatments are done based on experience, but there is no scientific proof that these     methods work for infants. GERD and feeding difficulties can lead to longer hospitalization     and more stress for the family.      In this clinical trial, the investigators are developing new methods to help with diagnosis     as well as defining better treatment strategies in relieving GERD and GERD complications.   "
61118|NCT02485574|"     The purpose of this study is to evaluation for the pattern of bone bridging of patients who     undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto     local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior     to auto local bone only. In addition, the investigators will analyze anterior new bone     bridging pattern between anterior bridging cage newly developed and grafted bone in anterior     disc space.   "
61051|NCT02486458|"     The anticaries effect of professional fluoride application has been associated with the     formation of calcium fluoride-like products (CaF2) on dental surface, which may function as     a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and     varnish are the most important, and have different soluble fluoride concentrations, pHs and     vehicles. Although the concentration of fluoride formed on enamel after the use of both is     similar, the retention of these reaction products is unknown. Also, it is unknown the     capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the     effect of the varnish application time on these parameters is unknown. Therefore, the aim of     this study is to compare the capacity of fluoride gel and varnish to form fluoride reservoirs     on enamel and increase dental biofilm fluid fluoride concentration with time. Rapid     biofilm-forming individuals will be selected to participate and divided into 4 experimental     groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish will be     applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be applied on     teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth. Microbiopsies of     enamel will be obtained by a microbiospy technique to assess fluoride concentration before, 7     and 28 days after the treatments. Dental biofilm will be collected before and 3, 7, 14 and 28     days after treatments. Fluoride concentration on enamel and in the biofilm fluid will be     determined by an ion-specific electrode. Data will be analyzed statistically comparing the     groups and collection times.   "
61052|NCT02486445|"     This prospective outcome study is designed to assess the safety of rivaroxaban in the     pre-diagnosis phase of DVT.   "
61053|NCT02486432|"     A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet®     (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach   "
61054|NCT02486419|"     The primary objective in this study is to examine the seasonal variation in genetic markers     in the deep neck adipose tissue in humans.      Human adipose tissue biopsies are taken from patients admitted for elective surgery in the     neck. During the surgical procedure a subcutaneous adipose tissue biopsy is taken for     reference.   "
61055|NCT02486406|"     The purpose of this three part study is to evaluate the pharmacokinetics (Part 1),     safety/efficacy (Part 2), and long-term follow-up (Part 3) of ombitasvir (OBV), paritaprevir     (PTV), ritonavir (RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in     pediatric subjects with genotype 1 or 4 chronic hepatitis C virus (HCV) infection.   "
61056|NCT02486393|"     The investigators conducted a prospective study of 132 patients undergoing benign parotid     surgery at our department. Their primary objective was to analyze the incidence of and     contributing factors associated with temporary and permanent postoperative facial palsy with     strictly standardized methods in facial nerve function evaluation. Also other complications     occurring within 12 months of operation were recorded.   "
61057|NCT02486380|"     This investigation is to evaluate the performance, comfort and ease of use of the Simplus and     Eson masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.   "
61058|NCT02486367|"     The central hypothesis of this study is that TAVR leads to platelet deposition and     inflammatory cell activation that can be attenuated by the potent anti-platelet and/or     pleiotropic effects of ticagrelor.      This single center, prospective randomized trial addresses the following specific aims:        1. To determine whether high-potency ADP receptor blockade reduces measures of platelet          activation in patients after TAVR.        2. To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic          inflammatory response observed after TAVR.   "
61060|NCT02486341|"     Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine     Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and     dependent patients due to its shorter action. However, no study has analysed the glycaemic     profile in elderly subjects according to the basal insulin used, particularly in frail or     disabled patients.      The aim of this study is to measure intra-day glycaemic variability according basal insulin     (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with     diabetes using continuous glucose monitoring system.   "
61061|NCT02486328|"     There are different sedation regimes for lower GIS endoscopy which can be administered by     anesthesiologists and non-anesthesiologists. This study aims to compare the effects of     propofol/remifentanil combination and midazolam/meperidine combination on early cognitive     function following lower GIS endoscopies.   "
61062|NCT02486315|"     The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System;     Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to     cover the lesion at the level of the carina. Although deemed ideal for lesions involving only     the proximal MV (1,0,0 according to Medina classification ref), this device may be used also     in more complex bifurcation lesions when additional DES are required in the distal MV and/or     in the SB. In the present registry the investigators report the performance and the efficacy     of the self-expanding biolimus-eluting AxxessTM stent for the treatment of bifurcation     lesions in a real-world population.   "
61063|NCT02486302|"     The purpose of this non-interventional study is to evaluate the efficacy of etanercept during     routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis,     psoriatic arthritis, axial spondyloarthritis, or plaque psoriasis. In so doing, particular     attention will be paid to the proportion of those patients who only attain the desired     treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is     the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,   "
61064|NCT02486289|"     A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of     mercury intoxication.   "
61065|NCT02486276|"     To develop a pragmatic migraine model the investigators will induce headache in healthy     volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor     (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug     candidates.   "
61067|NCT02486250|"     This is a three year study conducted in cooperation with the Brain Health Registry (BHR), an     internet-based registry which enrolls individuals in Northern California in order to     facilitate clinical trials for the prevention of Alzheimer's disease (AD). The investigators     goal is to validate the Brain Health Registry's online cognitive measures developed by     Lumosity. Investigators will meet this goal by collecting data from the newly developed the     BHR online cognitive screening battery along with standardized measures of memory, attention,     executive functioning and speed of information processing currently used in clinical trials     for Alzheimer's disease.   "
61068|NCT02486237|"     Retrospective, observational study to determine the prevalence of complications in Central     American diabetic patients.   "
61069|NCT02486224|"     Kona Deep is bottled water extracted from a depth of 3000 feet off the cost of Kona, Hawaii.     Kona Deep claims that this unique source provides water that is naturally free of pathogens,     chemicals and pollutants and rich in nutrients and minerals that are readily absorbed by the     body. The investigators wish to examine Kona Deep's claim that this water is beneficial to     the human body by testing the impact of drinking Kona Deep on exercise performance and     recovery. Subjects will be exercised to a safe level of dehydration and then will be     rehydrated with Kona Deep water, or commercially available bottled spring water or Gatorade     as controls. Subjects will perform a simple exercise to evaluate peak power performance. This     measurement will be compared between rehydration methods for significant differences.   "
61070|NCT02486211|"     This study evaluates if amantadine will increase the rate of awakening in patients     resuscitated from cardiac arrest but comatose (not following commands) after their     resuscitation. Half of the participants will receive amantadine and the other will receive     placebo.   "
61071|NCT02486198|"     The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium     injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.   "
61072|NCT02486185|"     Background to the research: Sarcopenia is a geriatric syndrome defined by progressive     generalised loss of skeletal muscle, mass, force and function.      Problem statement and objectives: To validate a simple, reproducible, screening tool, which     is easy to use in the general practitioner's surgery is one of the challenges of the future.      The primary objective is to assess the sensitivity and specificity of the study screening     test, the SARC-F, at a predetermined threshold of >= 4. A total score of >=4 is associated     with poor physical performance and is also predictive of the clinical diagnosis of the     disease. The secondary objectives are to assess the prevalence of sarcopenia in the study     population, to carry out a subgroup analysis of statistical performance for the five     questions tested by the SARC-F, to identify the main risk factors associated with the disease     and to propose an algorithm, positioning the SARC-F at the heart of a systematic screening     process for the disease.      Materials and methods: This is a diagnostic, cross-sectional study with a descriptive and     analytical epidemiological component to analyse the secondary endpoints. It will be carried     out in usual care over a period of 6 months in a homogeneous population of 65-year-old and     older patients from the community consulting in primary care. The subjects will undergo the     screening test (SARC-F questionnaire) and then the reference clinical assessment (gold     standard) in succession.      Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a     simple tool, appropriate for early screening of sarcopenia in primary care.   "
61073|NCT02486172|"     This is a pre-and-post study with a study duration of one year involving 7 diabetes centres     in Hong Kong. A group of motivated patients with type 2 diabetes will be trained as peer     supporters in two training workshops. Patients who may benefit from peer support program will     be recruited as peers. In the one year study period, peer supporters are required to have 2     face-to-face interviews and 12 phone calls. Clinical parameters and psycho-behavioral     parameters of both peer supporters and peers will be evaluated at the baseline and at the end     of the study.   "
61074|NCT02486159|"     Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in     allergic rhinitis patients before and after a series of acupoint herbal plaster and     Acupuncture treatment.      In the first year, Twenty-three participants with persistent allergic rhinitis each received     four acupoint herbal plaster treatments, applied using the moxibustion technique, and     clinical outcomes were evaluated using the Rhinitis Quality of Life Questionnaire (RQLQ).     Peripheral blood samples were analyzed using an ImmunoCAP Phadiatop test, and patients were     classified as phadiatop (Ph)-positive or -negative. Microarray results were examined for     genes that were differentially expressed between (1) Ph-positive and -negative patients     treated with herbal paste; and (2) before and after herbal paste treatment in the Ph-positive     patient group.      In the second year, Twenty-seven participants with persistent allergic rhinitis each received     four acupoint herbal plaster treatments and 8 courses of acupuncture treatment over 4 weeks     in the same time.   "
61075|NCT02486146|"     The purpose of this study is to establish the working protocols for a general biorepository     with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal     tract from a diverse range of clinical patients at the UC Davis Medical Center. The     establishment of a GI-specific biorepository will support future translational endeavors     within the UC Davis campus by providing laboratories with readily available GI tissue and     bodily fluid samples to test newly developed hypotheses with relative ease.   "
61076|NCT02486133|"     A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV)     Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard     of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase     Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with     RTV-boosted DRV in combination with 2 NRTIs.   "
61100|NCT02485808|"     The purpose of this study is to advance our understanding of people who experience urinary     and bladder problems. We are interested in learning about people's experiences with urinary     symptoms and how these symptoms will be managed. We want to understand the important     differences among people and what factors affect urinary and bladder problems. After all of     the information is collected, we will have a better understanding of how to improve the care     and treatment for people who have urinary and bladder problems.   "
67338|NCT02404324|"     The objective of this prospective study is the treatment of esotropia by prescribing the full     precise optical correction of refractive errors in children up to 3 years old.   "
61077|NCT02486120|"     Background:      - Suicide is one of the main causes of death for adolescents in the U.S. The most effective     way to decrease suicide is by training doctors to recognize the risk factors in their     clients. One risk factor for suicide is chronic illness. So pediatric genetic counselors come     across high-risk clients. But the suicide risk assessment (SRA) practices of these counselors     are not well known. Researchers want to study learn more about this.      Objectives:      - To describe the practices, attitudes, and beliefs of genetic counselors about SRA of     adolescents.      Eligibility:      - Genetic counselors who see adolescents ages 10 21      Design:        -  A study will be open to a listserv for genetic counselors.        -  Participants will take a survey on their own.        -  The survey will be online on a secure website.        -  Participants will give data about themselves. This can include age, gender, job, etc.        -  The survey will be about 60 questions.        -  The survey will take around 20 25 minutes.        -  The questions are about participants experiences, practices, attitudes, and beliefs          about SRA.   "
61078|NCT02486107|"     In case of cervical foraminal stenosis without central stenosis, there are several options;     anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF)     and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern     technique and there was no RCT with MTPF, although P-PECD showed not inferior result to ACDF.     Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no     comparative study.      The primary object of the study is to compare radiological outcome (segment angle) after MTPF     or P-PECD.   "
61079|NCT02486094|"     This study tests biopsy and tissue from patients who have been treated for primary rectal     cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at     post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and     proliferative index count pre and post chemoradiotherapy.   "
61080|NCT02486081|"     Children with disabilities are frequently ignored by the general population, hence the     development of movement evaluation and training devices for use in special education settings     are relatively overlooked. Usually the performance of these children is not stable and     contains variations. Hence in order to get a complete picture of their sport performance,     simply measuring movement time and distance is definitely not representative. With the rising     attention from government regarding fitness and social participation of the disabled in     recent years, developing a special-designed individual evaluation & training plan is of great     importance. To achieve this goal, a device which is able to record the complete process of     movement, and contains algorithm that can pick up the movement characteristics of children     with disabilities is needed. The purpose of this study is to design and develop a smart     soccer ball system for use in children with intellectual disabilities(ID), and to compare the     performance between children with ID and the typically developed.   "
61081|NCT02486068|"     The primary objectives of this trial are:      In patients at high-risk for restenosis,        -  To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the          everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF)          at 1 year        -  To assess superiority of the BRS to the EES in TLF between 1 and 5 years   "
61082|NCT02486055|"     This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy     subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving     a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a     single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The cohorts     may be enrolled sequentially.   "
61161|NCT02485015|"     The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with     cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with     advanced gastric cancer.   "
61083|NCT02486042|"     Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely.     These infants do not have enough essential fatty acids to structurally support the retina,     the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3     (n-3) fatty acids to these infants soon after birth made them less likely to need invasive     treatments for eye disease. This research trial will give young infants born prematurely n-3     fish oil treatment and look at how this changes factors in the blood that promote disease.     Detailed blood studies comparing infants with and without ROP will be performed and the     infants will be followed over time to assess their eye development.   "
61085|NCT02486003|"     This study will assess the effectiveness of a portable goggle system in the diagnosis of mild     traumatic brain injury (mTBI) in athletes.   "
61086|NCT02485990|"     This study will be looking at what dose of tremelimumab and olaparib is safe and effective in     patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal     Carcinoma).   "
61087|NCT02485977|"     The overall goal of this study is to evaluate agreement between cardiac MR parameters and     well-established clinical and catheterization parameters of poor prognosis in patients with     pulmonary hypertension. The identification of noninvasive cardiac MR techniques to evaluate     myocardial disease in patients with pulmonary hypertension would be beneficial to society due     to the potential to replace serial invasive cardiac catheterization procedures with a     noninvasive imaging test.   "
61088|NCT02485964|"     To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT) assay,     which measures antigen-specific interferon-secretion.   "
61101|NCT02485795|"     The purpose of this study is to evaluate the impact of genetic testing on healthcare     decisions and patient outcomes in interventional pain management clinical care. Results of     genetic testing will also be compared with the clinical outcome measures collected to     discover novel genetic factors that may influence patient care.   "
61102|NCT02485782|"     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume,     Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance     cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau)     beginning 15 min prior to midweek dialysis session and continuous measurement thereafter,     with a 15-min period after the termination of hemodialysis. Fluid overload were measured by     BCM Monitor Fresenius before hemodialysis.   "
67416|NCT02403310|"     The main purpose of this study is to determine the safety of combining selinexor with     daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin     and cytarabine will also be established.   "
61089|NCT02485951|"     Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to     create a uniform recipient bed, thereby reducing complications, such as interface     irregularity and opacification encountered with conventional lamellar keratoplasty. The     big-bubble technique provides a planned, safe, quick and consistent baring of Descemet     membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a     long learning curve with a low success rate of big-bubble formation and a high rate of DM     perforation when performed by surgeons in training. Different modifications to the original     technique using intraoperative instruments such as corneal pachymetry, anterior segment     optical coherence tomography (OCT), and femtosecond laser, have been used to increase the     chances of achieving a successful DM detachment from the deep stroma by air injection. Even     with these innovations, the rate of successful big-bubble formation did not reach 100%.     Recently, the investigators described a modification to the original big-bubble DALK in which     a 27-gauge needle was inserted into the stroma peripherally from the trephination site     towards the limbus. The investigators found that air injection peripheral to the trephination     can effectively and reproducibly separate the corneal stroma from the Descemet membrane (DM).     This study was aimed to compare the success rate and complications of big-bubble DALK using     central versus peripheral air injection performed by senior cornea fellows under the     supervision of an experienced faculty member in an academic hospital.   "
61090|NCT02485938|"     Male subjects with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all     inclusion and no exclusion criteria will be randomized. All subjects will be at least 12     years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of     CAP-1002 in three coronary arteries supplying the three major cardiac territories of the left     ventricle of the heart (anterior, lateral, inferior/posterior) or usual care. In the active     treatment arm, all three major cardiac territories will be treated (infused) during a single     procedure in an open-label fashion.   "
61091|NCT02485925|"     This is a prospective effectiveness and safety assessment of the study device during     radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial     fibrillation.   "
61092|NCT02485912|"     This is a clinical trial in which healthy volunteers will be administered two experimental     Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with     both vaccines one after the other in a prime/boost regimen.      All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8     pfu.      All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7     days later.      The site of administration of the MVA-EBO Z vaccine differs between the two groups:      Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.      Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.      The study will assess the safety of the vaccinations, and the immune responses to     vaccination. Immune responses are measured by tests on blood samples.      The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from     viruses which are modified so that they cannot multiply. The viruses have extra DNA in them     so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that     the immune system builds a response to Ebola without having been infected by it.      Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.   "
61093|NCT02485899|"     The Phase 1/2 study (190-201) evaluated the efficacy and safety of doses up to 300 mg/every     other week (qow) BMN 190 in patients with CLN2. The dose and regimen for this study (190-202)     are based on the results of the 190-201 study. The rationale for this phase 2 extension study     is to provide patients who complete the 190-201 study with the option to continue to receive     continued BMN 190 treatment. The 190-202 study is an open label extension protocol to assess     long-term safety and efficacy.   "
61094|NCT02485886|"     Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of     physiological conditions. In particular, recent evidence suggests this type of macrophage     response is important for the disease pathology of pulmonary fibrosis. Because cysteine     cathepsins are proteases that are highly expressed in antigen presenting cells such as     macrophages, they serve as promising biomarkers. Employing non-invasive imaging agents     68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential     to not only aid early detection but also significantly aid efforts to monitor progression and     patient response to therapy.   "
61095|NCT02485873|"     To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin     K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation     (SPAF) in a real-life setting   "
61096|NCT02485860|"     The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires     regular dressings (daily for 15 days and then every 48 hours) until complete healing. This     healing is obtained on average in 68 days. Some patients have difficulties in healing with a     final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary     wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing     is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of     honey in pilonidal cysts is not evaluated and may accelerate healing.   "
61097|NCT02485847|"     The IRIS™ Registry (Intelligent Research in Sight) is the nation's first comprehensive eye     disease clinical registry. The American Academy of Ophthalmology is developing it as part of     the profession's shared goal of continual improvement in the delivery of eye care.The IRIS     Registry will be a centralized system for ophthalmology practices to promote practice     innovations and achieve clinical excellence.   "
61098|NCT02485834|"     This randomized phase II trial studies how well fludeoxyglucose F-18 (FDG)/positron emission     tomography (PET) directed treatment improves response in patients with stomach or     gastroesophageal junction cancer that has not spread past the stomach and is not responding     to the usual treatment. PET scans are a different way to take pictures of cancer and can be     used to look at how much energy (such as glucose) is being used by the cancer. Using PET     scans early to monitor the success of treatment may allow doctors to measure response and     change treatment accordingly.   "
61099|NCT02485821|"     To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor     induction.   "
67417|NCT02403297|"     The purpose of this study is to learn if a chair-side testing device will accurately measure     levels of a salivary biomarker and thus indicate if a patient has periodontal health,     gingivitis or periodontal disease.   "
61104|NCT02485756|"     Previous studies have shown that women on anti-seizure medications are not informed about the     pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, AEDs)     and certain hormonal contraceptive. The goal of this proposed study is to develop and assess     the efficacy of an educational handout for participants on the ways AEDs and certain hormonal     contraceptives can interact to alter effectiveness of the medications. Reproductive age women     (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a patient     agrees to participate, she will be given a knowledge exam prior to the clinic appointment to     establish baseline understanding of hormonal contraceptive and AED interactions and then the     participant will be randomized to receive the intervention (educational handout) or the     standard of care (no educational handout). Those in participants in the intervention group     will read an educational handout on hormonal contraceptives/AED interactions. Those in the     standard care group will not receive this handout and the same knowledge exam will be     re-administered to all of the participants after they have completed their appointments to     check for knowledge comprehension and short-term knowledge retention. A same-day post-test     questionnaire will evaluate participant's intention to discuss hormonal contraceptives/AED     interactions with their gynecologist, neurologist or primary care physician.   "
61105|NCT02485743|"     This multi-centre, randomised controlled trial will be conducted over 24-weeks to evaluate     the effect of a healthy diet supplemented with a product specifically developed (SATIN     satiety products) to enhance feelings of satiety and reduce food intake after an initial     weight loss period to assess weight maintenance. Participants will either receive the active     SATIN product or a matched control product. The products contain ingredients which have been     shown to positively affect satiety, satiation and/or body weight and are all accepted food     ingredients approved for human consumption in Europe. They will be incorporated into     different food matrices, e.g. drinks, shakes and cheeses. Corresponding control products     without the active ingredients will be provided to participants allocated to the control     group. The participants will be instructed in detail on how and when to consume the test     products. Participants will be 300 adults (BMI >27kg/m2; Age>18years) who will be tested at     three research sites (University of Liverpool, United Kingdom; University of Copenhagen,     Denmark and University Rovira I Virgili, Spain). Recruitment will be divided between sites.     Participants will attend assessments at one of the three research sites continually     throughout the study period. The primary outcome will be weight maintenance after low calorie     diet as assessed by weight, waist circumference, body composition (DXA), energy intake and     subjective appetite assessments made at study test sessions. Secondary outcomes include     assessing biomarkers of health outcomes (blood and urine indices), changes in physical     activity as well as consumer benefits of the trial (assessed in a range of questionnaires) to     determine diet efficacy.   "
61106|NCT02485730|"     The ALFA study is a long term, prospective, observational study of AD patients' adult     children aimed at studying and characterizing key physio-pathological features of the     preclinical phase of AD.   "
61107|NCT02485717|"     To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for     the clinical cure of scabies after a single treatment. The trial will also assess the     pharmacokinetics (PK) of spinosad and benzyl alcohol following a single dose of Natroba™ in     pediatric subjects 4-16 years of age. These subjects will be a separate population of     pediatric subjects.   "
61108|NCT02485704|"     To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for     the complete cure of scabies after a single treatment.   "
62116|NCT02472535|"     A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in     patients with Homozygous Familial Hypercholesterolemia (HoFH).   "
61109|NCT02485691|"     Primary Objective:      To compare the radiographic progression-free survival (rPFS) of chemotherapy (cabazitaxel     plus prednisone, Arm A) versus AR-targeted therapy (enzalutamide or abiraterone acetate plus     prednisone, Arm B) in mCRPC patients who have been treated with docetaxel and who had disease     progression while receiving AR-targeted therapy within 12 months of AR treatment initiation     (≤12 months, either before or after docetaxel).      Secondary Objectives:        -  To compare efficacy for:        -  Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).        -  Progression-free survival (PFS).        -  Overall survival (OS).        -  Tumor response rate and duration of tumor response.        -  Pain response and time to pain progression.        -  Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.        -  Health status and Health-related Quality of Life (HRQOL).        -  To evaluate the correlation of a signature of resistance to AR-targeted agents with          clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as          expression and localization of proteins including AR isoforms in CTCs.        -  To evaluate safety in the 2 treatment arms.   "
61110|NCT02485678|"     Comparison of the number of ER plus hospital visits that occurred during chemotherapy between     the telephone intervention and control arms.   "
61111|NCT02485665|"     To evaluate the efficacy of postoperative pelvic floor muscle training using personalized     extracorporeal biofeedback device among patients with post-prostatectomy incontinence   "
61112|NCT02485652|"     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713     in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an     epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).   "
61113|NCT02485639|"     The primary objective investigate the longevity of humoral immunity to influenza virus in     humans. Our overarching hypothesis is that an understanding of how long-term humoral immunity     to influenza virus is generated and maintained is essential for the development of a     universal vaccine against influenza virus. The secondary objective is the longitudinal     tracking of vaccine-induced B cells responses with special emphasis on broadly neutralizing     HA stem reactive responses.   "
61114|NCT02485626|"     The purpose of this study is to evaluate the prevalence of (sub)clinical cardiovascular     disease, cardiovascular risk factors and metabolic abnormalities among long-term breast     cancer survivors treated with or without anthracyclines in order to identify patients at     increased risk of developing cardiovascular disease.   "
61115|NCT02485613|"     Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis,     the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with     AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy     and safety of BD as the first-line treatment of patients with AL amyloidosis.   "
61119|NCT02485561|"     This is a study examining the effects of different educational-motivational materials about     colorectal cancer screening on perceptions and intentions to get screened. Eligible     participants will be randomized to one of three experimental conditions. All participants     will be provided information about colon cancer and screening options based on the Centers     for Disease Control and Prevention (CDC's) Screen for Life materials. Some participants also     will be asked to read a personal narrative about colon cancer screening. This study will     determine whether participant's perceptions about and colorectal cancer screening intentions     and behaviors differ by which information they read. Participants will complete surveys     before, immediately after, and one month after randomization. Participants can complete all     study requirements through the study website: http://HealthStudy.wustl.edu   "
61120|NCT02485548|"     This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and     toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for     patients with locoregionally advanced head and neck squamous cell cancer.   "
61121|NCT02485535|"     This phase I trial studies the side effects and best dose of selinexor when given after stem     cell transplant in treating patients with acute myeloid leukemia that is at intermediate or     high risk of spreading or coming back (intermediate- or high-risk), or myelodysplastic     syndrome that is at high risk of spreading or coming back (high-risk). Selinexor works to     stop cancer growth by blocking an enzyme, which may cause cancer cells to die and also kill     cells that cause the cancer to grow, which commonly do not respond to regular chemotherapy.   "
61122|NCT02485522|"     Fecal Incontinence (FI) is a debilitating and common condition with a prevalence ranging from     7-15% in community dwelling women. FI has an immense impact on quality of life and is     associated with increased care giver burden, increased rates of institutionalization, and     significant cost burden in older women. Traditionally believed to be primarily caused by     child birth injury, recent studies show that the typical age of onset of FI is age 40 which     is remote from child birth. Treatment options for FI are limited because the mechanism     underlying FI in older women are poorly understood. The overriding goal of this project is to     investigate the relationship between diet, stool metabolites and fecal incontinence.   "
61123|NCT02485509|"     A combined Phase Ib and IIa randomized, placebo-controlled, double-blind study of VM-1500 in     healthy subjects and in patients with HIV-1 infection that are antiretroviral therapy naïve.   "
61124|NCT02485496|"     The purpose of this study is to evaluate clinical and technical success as well as safety and     feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal     aortic aneurysm.   "
61125|NCT02485483|"     The purpose of this study is to validate standardized questionnaires on depression for RA and     to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I     and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval of 3     months regarding their current emotional condition using standardized questionnaires. On the     basis of the results of VADERA I, in VADERA II, the selected questionnaire will be used to     assess the prevalence of depression with RA in approximately 1000 participants.   "
61183|NCT02484729|"     This study will be a randomized, single-blind, placebo-controlled first-in-human study in     healthy male subjects to assess the safety, tolerability and pharmacokinetics of single     ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along     the gastro-intestinal tract will be investigated using the IntelliCap® system in a     non-randomized, open-label, fixed-sequence design. The study will be performed at a single     study centre.   "
61126|NCT02485470|"     The goal of this study is to test, in a randomized controlled trial among head and neck     cancer patients, the short and longer term effects of the MPACT (Maintaining Physical     Activity during Cancer Treatment) program (infused with motivational interviewing and     self-determination theory-based strategies) initiated at the time of concurrent chemotherapy     with radiation (CCRT), on key outcomes such as functional mobility and quality of life, and     ultimately physical activity. The central hypotheses is that in head and neck cancer patients     undergoing CCRT, the MPACT program, as compared to usual care controls, will result in less     acute decline, faster recovery, and better maintenance of these key outcomes.   "
61127|NCT02485457|"     The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output     monitor) to detect stroke volume variation induced by leg raising or fluid expansion during     surgery   "
61128|NCT02485444|"     This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at     induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or     observation with no pharmacologic intervention. Primary outcome of the study is complete     abortion rate within two hours of fetal delivery.   "
61129|NCT02485431|"     This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed     to assess the comparative bioavailability and food effect of deflazacort. A total of 45     subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing     sequence will be enrolled in parallel and all subjects will receive all 5 treatments in a     crossover fashion.   "
61130|NCT02485418|"     Propofol has been used in adult populations to treat migraines as an abortive agent.     Investigators plan to investigate its efficacy as an abortive agent in the pediatric     population when administered as a safe low-dose infusion. Goals of the study are to:        1. Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric          migraine headaches        2. Evaluate effective and safe dosing limits in pediatric populations        3. Evaluate duration of effect reached from a low-dose propofol infusion as an abortive          agent      Endpoints for the study will be:        1. Number of enrolled patients        2. Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence          Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under          the guidance and supervision of a board certified pediatric anesthesiologist with the          appropriate monitoring equipment and readily available emergency equipment.          Investigators hope to demonstrate more rapid improvement and decreased side-effect as          compared to standard care.   "
61131|NCT02485405|"     The purpose of this study is to analyse gut permeability and stress.   "
61132|NCT02485392|"     A single-blinded randomized clinical trial (RCT) designed to compare Single-Site     robot-assisted with single-incision laparoscopic cholecystectomy. The study directly compares     both surgical approaches in a cohort of 60 patients (30 patients in each arm) with benign     gallbladder disease from the Department of Surgery at the Cantonal Hospital of Winterthur     (Kantonsspital Winterthur) in Switzerland. The primary endpoint of the study is the surgeon's     physical and mental stress load at the time of surgery and is assessed by validated Local     Experienced Discomfort (LED) and Subjective Mental Effort Questionnaire (SMEQ) visual     analogue scales. The secondary endpoints include costs of the procedure, intra-operative     blood loss, operating time, intra-operative conversion rate and additional trocar placement,     complications, length of hospital stay, Health-Related Quality of Life (HRQoL) and cosmesis.     HRQoL and cosmesis will be assessed using the validated Gastrointestinal Quality of Life     Index (GIQLI) and the Body Image Questionnaires (BIQ), respectively. The inclusion criteria     cover most notably symptomatic cholecystolithiasis, chronic cholecystitis, benign gallbladder     polyps and age ≥18 years. The exclusion criteria are, among others, acute cholecystitis,     emergency cholecystectomy, previous extensive upper abdominal surgery and suspicion of     malignant disease. Non-stratified block randomization (random block sizes 2 and 4) will be     used to achieve balance in the allocation of participants to both treatments arms and prevent     a premature decoding of the randomization scheme. Hereby, the patient will not be informed     about the group assignment until the last outpatient follow-up and only after he/she has     completed and returned all required questionnaires (GIQLI and BIQ). The operation will be     performed according to the group assignment by senior surgeons only who have a wide     experience in both robotic Single-Site and conventional single-incision laparoscopy. All data     are recorded safely using the SecuTrialTM program. Sample-size calculations are based on the     results of the previously mentioned experimental setup by Schatte et al, utilizing an     estimated effect size of 0.8, at a power of 0.8 and an alpha-error level of 0.05, as well as     considering a potential additional error margin of 10-15% of the calculations (G-Power 3.1     software, Heinrich-Heine University Duesseldorf/Germany). The estimated total duration of the     study is 1.5 years, including the scheduled 1-month and 1-year postoperative follow-up     visits. The study will be carried out in accordance with principles enunciated in the current     version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued     by International Conference on Harmonization (ICH), and Swiss regulatory authority's     requirements.   "
61177|NCT02484807|"     The development of disease-targeted medication for the treatment of pulmonary arterial     hypertension (PAH) has significantly improved within the last years, leading to the     development of 10 approved agents. Combination treatment with Endothelin-Receptor-Antagonists     (ERA) and Phosphodiesterase-Type-5-Inibitors (PDE-5-Inhibitor) has become increasingly     important for the treatment of PAH. In a recent press release, the results of the AMBITION     study reported that an upfront combination treatment immediately after diagnosis leads to a     delayed disease progression [4]. Thus, the question if there is a clinically relevant     pharmaco-dynamic drug-drug interaction is of rising interest.   "
61133|NCT02485379|"     Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of     suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific     Antigen (PSA) level, it is currently recommended to perform blinded systematically     distributed biopsies with 10-18 samples obtained from predefined locations in the gland.      These so-called systematic biopsies (SB) may lead to improper patient management by (i)     missing clinically significant cancer, especially in the anterior half of the gland that     tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer     foci that may result in overtreatments, (iii) undersampling the tumor foci and thus     underestimating their volume and aggressiveness.      Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in     detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that     targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive     cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the     aggressiveness of detected cancers than SB. However, these monocenter studies only provide     low-level evidence and three recent independent reviews of literature concluded that there     was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared     to SB. This is particularly important since many academic and private centers in France     already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that     this approach becomes the norm without being properly evaluated and it is crucial and urgent     to perform a controlled multicentric study to provide high-level evidence as to whether     mp-MRI should or should not be obtained before prostate biopsy.      One controlled multicentric study has been published recently in which SB and TB had been     obtained by two different operators in 95 patients. TB yielded a significantly higher     detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant     cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients     with negative mp-MRI were not included.      Research hypotheses: There is currently no robust multicenter trial comparing prostate TB     based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre     prospective trial comparing the results of SB and TB performed in the same patients by two     independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a     significantly higher percentage of patients than SB.      Main objective: To compare the percentage of patients with clinically significant cancer     (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.   "
61134|NCT02485366|"     Blood transfusion is nearly always needed during open heart surgery in children less than 15     kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the     organs and tissues of the body. Stored blood undergoes some changes that may make it less     effective in achieving this goal. The purpose of this study is to see if restoring important     energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with     a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood     transfusion. This is a Food and Drug Administration (FDA) approved process that is described     by the American Association of Blood Banks for prolonging blood storage but not used for     everyday transfusions. The investigators want to use this process to improve blood transfused     to children undergoing heart surgery.      Although Rejuvesol has been previously approved by the FDA, it is not routinely used to     prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this     study is considered investigational. This is a pilot study and data will be collected for     future protocol development.   "
61135|NCT02485353|"     This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the     treatment of adults 60 years of age or older with previously untreated acute myeloid     leukemia. A total of 17 evaluable patients are planned to be treated on the study.   "
61136|NCT02485340|"     To develop a pragmatic migraine model the investigators will induce headache in healthy     volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO)     donor. If the headache responds to sumatriptan, the model can be used to test new drug     candidates.   "
61137|NCT02485327|"     Primary Objective:      To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to     insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM     patients in a euglycemic clamp setting.      To characterize the within-subject variability in the metabolic activity (pharmacodynamic     [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp     setting.      Secondary Objectives:      To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a     euglycemic clamp setting.      To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a     euglycemic clamp setting.      To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a     euglycemic clamp setting.   "
61138|NCT02485314|"     The Participation and Environment Measure for Children and Youth (PEM-CY) is the first     instrument that combines parental assessment of children's participation in home, school, and     community activities with qualities of each environment that are perceived to support or     hinder participation. This combined format may help to clarify the relative impact of     environmental factors (including the natural and built environment), compared to personal     factors, on children's participation in specific settings. The aim of this study was to     examine reliability and validity of Turkish version of the Participation and Environment     Measure for Children and Youth (PEM-CY).   "
61139|NCT02485301|"     The purpose of this study is to assess the safety and immunogenicity of the investigational     ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose     Considering the risk of exposure to Ebola and the potential (based on animal data) for the     investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in     the study will receive the investigational ChAd3-EBO-Z vaccine. The subjects in the Group     EBO-Z will receive the vaccine at Day 0 of the study, whereas the subjects in the Group     Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the     investigational ChAd3-EBO-Z vaccine at Month 6, provided that no safety concerns are raised.     In addition, vaccinating all subjects in the study with the investigational ChAd3 EBO Z     vaccine will allow an increase of the safety database of the investigational vaccine. In case     the geographic range of Ebola virus Zaire (EBOV) transmission expands to encompass any of the     regions where this trial is conducted, earlier administration of the investigational     ChAd3-EBO-Z vaccine to the subjects in the Group Placebo/ EBO-Z will be considered in that     region.   "
61140|NCT02485288|"     The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical     data from electronic health records (EHR) and patient reported outcomes (PRO) to answer     questions of clinical importance to patients, providers, and other stakeholders.   "
61141|NCT02485275|"     The purpose of this study is to explore the value of new imaging technique package in     predicting early neurological deterioration and early recurrence of stroke in patients within     72 hour of stroke onset.   "
61206|NCT02484430|"     This phase II trial studies how well sapanisertib works in treating patients with acute     lymphoblastic leukemia that has returned after a period of improvement (relapsed) or has not     responded to previous treatment (refractory). Sapanisertib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth.   "
83885|NCT02188004|"     primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases     in subjects.      Secondary purpose:Analyze risk factors of HPV infection and related diseases.   "
61142|NCT02485262|"     Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease     worldwide. The virus successfully evades host immune detection and has highly restricted     requirements for growth in vitro that for many years hampered efforts to find a safe,     uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated     interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care     (1-5). PR therapy offered limited performance and availability across the diverse spectrum of     HCV disease and was fraught with excessive and often limiting side effects. The first direct     acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and could     only be used only in combination with PR because of concerns for rapid PI viral resistance.     Although the first generation PIs added increased efficacy to the PR regimen, they also added     new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a potent     nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The drug has     low toxicity, high resistance barrier, and minimal drug interactions with other HCV DAAs such     as PIs and anti-NS5A agents. SOF is safe and effective across different viral genotypes,     disease stages, and special patient groups such as those co-infected with HIV. When used in     combination with ribavirin or another DAA, SOF has revolutionized the HCV treatment spectrum     and set the stage for nearly universal HCV antiviral therapy. Sustained virologic response     (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for genotype 1 and 85-94%     for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor) showed a 94% SVR12 for     genotype 1 (9-16). More so than any other anti-HCV drug developed to date, SOF offers the     widest applicability for all infected patients yet can be given in a personalized regimen to     maximize performance   "
61143|NCT02485249|"     To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate     ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients     with macular edema (ME)   "
61144|NCT02485236|"     The study aims to compare the efficacy of Nasal High Flow Therapy (NHF) with low-flow oxygen     supplementation in improving postoperative intermittent desaturations. If so, this mode of     therapy would provide a cost effective, relatively easy to implement, and better tolerated     treatment to Continuous Positive Airway Pressure (CPAP) for oxygen stabilization.   "
61145|NCT02485223|"     This is a pilot study (a small scale study testing procedures so that the investigators can     apply this to a larger scale study). This study will test the accuracy of a new brain scan     (Magnetic Resonance Imaging) technique in predicting the diagnosis of multiple sclerosis (MS)     in patients where there is uncertainty about the diagnosis. For patients where there is a     suspicion (but not definite) diagnosis of MS, an additional MRI brain scan will be offered.     There will be no other research tests and the patient is followed up to see what the eventual     diagnosis is. The investigators will then review the original brain scan to see if this     predicted the diagnosis of MS or not.   "
61193|NCT02484599|"     The purpose of this study is to test the therapeutic effects of a computerized attention     training for patients with Anorexia Nervosa (AN). The primary aim is to determine if a     computerized attention training can modify attention towards food and ameliorate eating     disorder symptoms and related difficulties, such as anxiety. The secondary aim is to explore     underlying mechanisms that contribute to these improvements. The stability of potentially     observed effects over a one-month period will also be determined.   "
61146|NCT02485210|"     The elimination of pathogenic microorganisms from the root canal system is one of the main     points in order to have success in endodontic treatment. The objective of this study is to     perform a randomized controlled clinical trial to compare the effectiveness of success in     endodontic treatment of primary teeth when combined with photodynamic therapy. Will be     selected 30 primary teeth of children aged between 3 and 6 years. The teeth will be divided     into two groups: group I control, which will be applied the conventional endodontic treatment     and group II to be held endodontic treatment with application of photodynamic therapy. In     both groups will be made microbiological evaluations before and after endodontic treatment     and clinical and radiographic evaluations will be conducted in the day, 1 month, 3 months and     6 months after treatment comparing the treatment performed in both groups.   "
61147|NCT02485197|"     This is a small pilot aerobic training trial designed to examine differences between     normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by     non-invasive Hybrid Diffuse Optical Spectroscopy.   "
61148|NCT02485184|"     portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver     cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular     intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis     in liver cirrhosis with variceal bleeding.   "
61149|NCT02485171|"     The main objective of this study is to evaluate the feasibility and acceptability of the use     of the robot SAFEWALKER complement classical rehabilitation in a group of elderly patients     over 70 years during the rehabilitation of post-fall syndrome.   "
61150|NCT02485158|"     The purpose of this study is to examine whether individual differences in acute responses to     drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and     delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who     experience greater rewarding effects from one drug will also experience more rewarding     effects from the other drugs.   "
61151|NCT02485145|"     Osteoarthritis (OA) affects over 30 million people in the United States and represents our     nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA     raised overall health care costs by $185.5 billion annually. Largely as a consequence of this     disease, the number of patients undergoing joint replacement surgery will quadruple over the     next 17 years. Importantly, several recent studies have demonstrated that OA is an     independent risk factor for cardiovascular disease . Presently investigators have no     medications that alter the natural history of OA. Weight control, exercise and some physical     therapy measures are the only interventions short of total joint replacement that alter the     course of this disease. To make matters worse, investigators have experienced only setbacks     in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal     anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently     available armamentarium for pain control in OA . Clearly OA is a major factor that demands     better solutions as the health care system is redesigned.      OA involving the hands represents a major part of the overall burden of this disease. In     radiographic surveys about a quarter of the total US population has changes consistent with     OA involving the hands. Among the elderly, radiographic hand OA has been found in over half     of such individuals and as many as a quarter of them suffer from pain and functional     incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint,     the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints .     Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and     a variety of physical measures such as physical therapy, bracing, and heat and cold     applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical     therapies have been developed which either act as counter irritants, seek to reduce substance     P (capsaicin), or to deliver an NSAID locally through the skin. The leading example of the     latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand     function in a double blind controlled trial. However none of these measures have proven     sufficiently effective to meet patient needs. Topical polytherapy will be employed in this     study to see if it will be effective against the pain of OA.   "
61245|NCT02483910|"     The purpose of this study is to test whether Direct Instruction - Language for Learning     (DI-LL) is an effective way to teach language skills to children with autism spectrum     disorder (ASD) and moderate language delay. Direct Instruction - Language for Learning     (DI-LL) uses face to face instruction and specific lessons to teach children language skills.     This method has been used previously in children with language delays, but it has not been     carefully studied in children with autism spectrum disorder. This study will compare DI-LL     and ongoing treatment as usual to treatment as usual (speech therapy, language services,     etc.) alone.   "
61152|NCT02485132|"     Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is     known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on     glycemic control and quality of life among patients using sulfonylureas (SUs). The frequency     of hypoglycemia is probably underestimated since self-monitoring of blood glucose (SMBG) fail     to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia     unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). No previous     studies have reported total hypoglycemia as measured by continuous glucose monitoring system     (CGMS) in a large group of Canadians, therefore underestimating the true incidence of these     events. As with age hypoglycemia perception is reduced and consequences can be increased due     to frailty, elderly could be especially sensitive to the risk of hypoglycemia. Documentation     of the total number of hypoglycemia is a relevant objective to really appreciate the     potential impact of SUs in the Canadian context.      The investigators propose a multicenter observational prospective study in order to study the     incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus     (T2DM) newly prescribed a SU. The investigators propose to perform a baseline testing     (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and     after a 3 months follow-up of treatment, including medical history measures, quality of life     and diabetes treatment satisfaction.      In patients with T2DM not at goal (A1c >7.0 mmol/L), and newly prescribed a SU, the     objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as     measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period     following the initiation of the SU.   "
61153|NCT02485119|"     The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability     and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with     advanced, refractory solid tumors.      The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.   "
61154|NCT02485106|"     This study aimed to investigate the effect of decontamination by rifaximin in severe     alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be     randomly allocated to rifaximin group or control group.   "
61155|NCT02485093|"     Optimal pacing strategy for patients with SND is still unknown, although several publications     in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing     has always been apical in these trials, and to which extent this absence of pacing is     beneficial for patients with very long PR intervals is still to be found.      The aim of this study is to compare ventricular septal pacing to no pacing in patients with     SND.   "
61156|NCT02485080|"     The goal of this pilot study is to examine both efficacy and tolerability in patients with     HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT     score is used to assess the prognosis of chronic liver diseases, as well as the required     strength and treatment and necessity of liver transplantation. A higher CPT score denotes     higher necessity of liver transplantation.   "
61162|NCT02485002|"     This study will include patients aged between 18 and 65 who will undergo retrograde     infrarenal surgery (RIRS) due to renal stone(s). A total of 60 patients (male or female) will     be recruited, and will be randomized into 2 groups consisting of 30 patients in each group.     The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned     prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases     the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or     not affects the kidney functions. besides the routine kidney function tests, namely urea and     creatinine, neutrophil gelatinase-associated lipocalin (NGAL) (a more specific and early     marker of kidney function) will be used to assess the differences in the kidney functions.     Preoperative blood urea and creatinine levels and urine NGAL levels will be studied for all     patients. After the surgery, blood urea and creatinine levels will be again studied as well     as urine NGAL levels at postoperative 2nd hour, 72nd hour and 1st week.   "
61163|NCT02484989|"     Currently, there is little recent data on regional variations in treatment methods, neonatal     units that provide retinopathy (ROP) treatment, facilities for treatment available at each     unit including anaesthetic support for such preterm babies, facilities to transfer babies to     units that offer treatment etc. While some parts of the UK have established neonatal networks     and agreements among units for ROP treatment, in other parts, such arrangements are     illdefined.      The number of babies needing ROP treatment may be higher since the introduction of revised     guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting     epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence     of treatable ROP, the treatment methods used and facilities for treatment will provide the     foundation for effective planning of resources and manpower to deal with the additional     demand.   "
61164|NCT02484976|"     BASIC fMRI is a prospective single center intervention trial using fMRI imaging in 9-11 year     old obese male and females pre and post family-based behavioral treatment of 24 weeks     duration to determine the relationship between impulsivity and central satiety responses.   "
61257|NCT02483754|"     The study was designed to employ MOCA to screen mild cognitive impairment (MCI) in military     retirees and to analyze the associated risk factors. As such, MOCA was revised to be     validated for the Chinese context.   "
61258|NCT02483741|"     Since there is an evidence that Manuka honey is an antibacterial agent, the present study     aims to confirm this characteristic and assess its effect in improving healing and reducing     postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular     third molars   "
61165|NCT02484963|"     All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary     Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth     sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy     proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric     illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients     who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index     will undergo polysomnography and will be randomised to two groups after fulfilling all     inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily     and patients in control group will receive placebo at bed time daily. The treatment will be     continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and     polysomnography. All patients will be advised regarding sleep hygiene.   "
61166|NCT02484950|"     The primary objective of this study is to compare the clinical outcomes of arthroscopic     rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs).     Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines     and by supplying growth factors to their implanted environment. They have been shown to be     effective in improving both overall healing and tendon integrity in rotator cuff repair. This     study will follow 100 patients in the United States and track their clinical outcomes for at     least one year post-operatively.   "
61167|NCT02484937|"     This study will demonstrate that functional improvement measures over a 6-month period for     chronic low back patients under the care of Primary Care Provider (PCP), using a therapeutic     plan formulated initially by the Pain Medicine Specialist (PMS), are equivalent to those     under the care of the PMS only. Chronic low back pain patient will be initially be evaluated     by the PMS. If no interventional pain therapy is required, a multimodal therapeutic plan     (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low     back pain. Patients will be randomized into one of the two groups: Group 1 - Subjects will be     treated monthly for the following 6 months by PMS, and Group 2 - Subjects will be treated by     their own PCP for monthly visits for 6 months.   "
61168|NCT02484924|"     A retrospective real world analysis of bleeding events with ticagrelor compared to     clopidogrel in ACS patients.   "
61169|NCT02484911|"     The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in     combination with olanzapine ,palonosetron and dexamethasone for the prevention of     chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately     emetogenic chemotherapy.   "
61170|NCT02484898|"     The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the     clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry     System/External Cardiac Monitor System (MCT/ECM).   "
61171|NCT02484885|"     Healthy volunteers aged 18-85 will undergo hyperpolarized 129-Xe MRI and pulmonary function     testing for the development of tools to assess image signal to noise and reproducibility of     spin-density and diffusion-weighted imaging.   "
61172|NCT02484872|"     Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the     Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of     the study is to look at the prognostic and predictive value of inflammation during cancer     evolution, on the risk of complications leading to ICU admission and the risk of death.   "
61173|NCT02484859|"     Functional endoscopic sinus surgery (FESS) is indicated in diseases such as chronic sinusitis     refractory to medical treatment, nasal polyposis, mass lesions in the nasal cavity. The     purpose of this study is to determine whether tramadol and metoprolol are as effective as     remifentanil in providing controlled hypotension during FESS.   "
61174|NCT02484846|"     Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions     that were at least five days apart. The first session was a baseline. The sleep intervention     took place on the night prior to Session 2, where the amount of time in bed was manipulated     to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective     (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness     were measured. During the middle of each session, a 40-minute ad libitum meal opportunity     allowed participants to eat from eight different food items. Food healthfulness, caloric     density, distribution and number of calories were measured and compared to alertness levels.   "
61175|NCT02484833|"     -  To investigate whether cetuximab alone (given until progression or cumulative toxicity)          after 8 cycles of FOLFIRI + cetuximab results in a non inferior Progression Free          Survival when compared with continuous FOLFIRI + cetuximab (given until progression or          cumulative toxicity).        -  To assess whether an improvement in the incidence of grade 3-4 hematological and          non-hematological adverse events (AEs) can be achieved in the experimental arm          (cetuximab alone after 8 cycles FOLFIRI + cetuximab) as compared to the continuous          chemotherapy arm (FOLFIRI plus cetuximab)        -  To explore the possibility of using liquid biopsies for molecular profiling as well as          monitoring treatment activity in mCRC pts receiving cetuximab based therapy   "
61176|NCT02484820|"     In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a     premature birth in 25.4% of cases.      After 48 hours effective tocolysis, patients do not receive any further treatment while their     risk of premature birth has risen from 6.5% to 25%.      A pessary is a silicone ring encircling the cervix. It was initially used as medical     treatment of genital prolapse but studies were also conducted for pregnant women in 2     high-risk premature birth situations: cervical incompetence and twin pregnancies.      The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients     between 18 and 22 weeks of gestation showed a significant reduction of premature birth before     34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in     patients presenting a resolutive threatened preterm labor will also be effective.      To evaluate this hypothesis, the investigator designed a randomized prospective single-center     open clinical trial comparing pessary associated with standard care (1st group) versus     standard care only (2nd group) in patients experiencing an episode of resolutive threatened     preterm labor.   "
61259|NCT02483728|"     The purpose of this study is to evaluate if metal patch testing in metal allergic patients is     useful for predicting the development of allergic skin disease or systemic symptoms in     patients who recieve a metal orthopedic implant.   "
61178|NCT02484794|"     Cognitive behavioural therapy (CBT) is the most empirically supported and researched     treatment for eating disorders. A central component of CBT for eating disorders is     self-monitoring which involves patients keeping a paper food record of their meals and     associated thoughts, feelings, and behaviours and receiving feedback from a clinician to help     target dysfunctional cognitions and behaviours. Given the issues associated with paper     journals such as non-compliance, feelings of shame when used in public, and delayed feedback,     researchers have developed an evidence-based smartphone application (Recovery Record) for     eating disorder self-monitoring that links patients with their clinicians and offers     additional features designed to enhance treatment.      The current pilot randomised controlled trial (RCT) seeks to evaluate this smartphone     application in a clinical setting alongside standard eating disorder outpatient treatment.     Patients will be recruited from the Nova Scotia Health Authority Eating Disorder Outpatient     Program and randomised to receive either standard treatment or standard treatment with the     app (instead of the paper food record). The efficacy and acceptability of both treatments     will be assessed and compared. Coping skill use and self-efficacy among patients will also be     examined given the skill building focus of treatment and in-app capabilities to deliver     real-time coping skill suggestions to patients.      This pilot study will be the first to examine the efficacy and acceptability of a smartphone     application in eating disorder clinical treatment and if successful, should provide     preliminary support for the use of smartphone applications over traditional paper food     journals as a self-monitoring tool for augmenting specialty eating disorder clinical     treatment.   "
61179|NCT02484781|"     Total hip replacement surgery is a very successful operation with good long-term results. Hip     resurfacing arthroplasty is offered as a treatment option for young and active patients with     osteoarthritis of the hip. It has been proposed as a treatment option for younger patients     because of claims that it preserves femoral bone stock and has better functional outcomes.     The assessment of gait after hip replacement surgery may be able to determine functional     differences between patients who have undergone total hip replacement / arthroplasty (THA)     versus hip resurfacing.   "
61180|NCT02484768|"     The purpose of this study is to to establish proof-of-concept for efficacy of iron     isomaltoside 1000 in subjects with Restless Legs Syndrome.      The study is a randomised, comparative, double-blind study with a 3 months extension.     Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following     treat-ment groups:        -  Group A (42 subjects): 1000 mg iron isomaltoside 1000        -  Group B (21 subjects): Placebo infusion      Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg     iron isomaltoside 1000 at week 6.   "
61181|NCT02484755|"     The USP8 gene and its downstream target, epidermal growth factor receptor (EGFR), is a     potential therapeutic target of Cushing disease. The EGFR inhibitor, Gefitinib, has been     shown to reduce the production of ACTH both in vitro and in vivo, especially in USP8-mutated     corticotrophin adenomas. The investigators hypothesize that Gefitinib will suppress pituitary     corticotroph tumor ACTH production and normalize urinary free cortisol levels in patients     with USP8-mutated Cushing's disease. Gefitinib is an FDA approved drug used to treat     non-small cell lung cancer. However, in this study, the drug will be used to treat     corticotrophin adenoma.   "
61182|NCT02484742|"     The main purpose of this study is to learn about the effects of repeated exposure to sleep     disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep     is shortened and disrupted, followed by a single night of recovery sleep) on inflammation,     mood, and pain processing (experiences/perceptions of pain). Purpose of this research project     is to understand the mechanisms of how sleep disruption may change mood and the experience of     pain. Understanding those mechanisms is important to develop interventions that may help to     reduce the effects of sleep disruption on mood and pain.   "
61184|NCT02484716|"     Timolol is a nonselective β-blocker commonly used in the treatment of glaucoma. Recently it     has been used topically for the treatment of superficial hemangiomas. Because of its     potential mechanism of action, it is possible that timolol could also be useful for the     treatment of epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT). Moreover a case was     reported in 2012 showing an improvement of nosebleeds with the use of topical nasal timolol.     The aim of the study is to evaluate timolol nasal spray efficacy in HHT.      The main objective of this trial is to evaluate, 3 months after the end of the treatment, the     efficacy on the duration of nosebleeds of a 4 weeks timolol intranasal treatment in HHT     patients with nosebleeds (>20 min/month). Secondary objectives are to evaluate the tolerance,     the efficacy at 6 months after the end of the treatment, and the efficacy on anemia and on     clinical parameters (nosebleeds, quality of life and blood transfusions).      This is a prospective double blind phase II study, randomized versus placebo using an     allocation ratio of 1:1. A total of 58 patients will be included. The product (solution with     timolol at 0.5% or placebo) is self-administered by the patient with a posology of one spray     (50 µL) in each nostril twice a day for 28 consecutive days.   "
61185|NCT02484703|"     This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic and     pharmacodynamic activity of 3 different dosages of RO5186582 compared with placebo. A total     of approximately 46 participants will be enrolled, in order to have at least 32 evaluable,     and will be randomly assigned to 1 of 4 treatments in a 1:1:1:1 ratio, with 9 children per     treatment arm. The target ratio between 6-8 years and 9-11 years age groups is approximately     1:1 in each treatment arm, with a minimum of 3 children per age group in each treatment arm.   "
61186|NCT02484690|"     This multiple-center, multiple-dose and regimen, randomized, double-masked active     comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the     efficacy, safety, tolerability, and pharmacokinetics of RO6867461 in participants with CNV     secondary to AMD.   "
61187|NCT02484677|"     Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) is a mainstay for treating head and neck     cancers, but elderly or fragile patients are often precluded because of the risk of severe     toxicities associated with this protocol. DPD (Dihydro Pyrimidine Dehydrogenase) deficiency     is a pharmacogenetic syndrome responsible for most of the severe/lethal toxicities showing in     5-FU (5-Fluorouracile)-treated patients, and our institute has developed a strategy for the     routine determination of Dihydro Pyrimidine Dehydrogenase (DPD) status prior to starting     giving the 5-FU so as to roughly adapt drug dosage according to the Dihydro Pyrimidine     Dehydrogenase (DPD) status. This project aims at developing a Bayesian strategy to further     individualize 5-FU dosing to reach a target exposure of area under curve (AUC). To this end,     100 patients with head and neck cancer and scheduled for a Docetaxel, Cisplatin,     5-Fluorouracile (=TPF) regimen will be included.   "
61188|NCT02484664|"     The investigators will perform a two-center phase I trial of celecoxib (COX-2 inhibitor)     administered at 200mg by mouth daily for 6 months. Up to 12 adult women with LAM will be     recruited (between 4-8 at each site). The Specific Aims are:      Aim 1: To investigate whether, in LAM patients, celecoxib is safe and well tolerated, and has     evidence of clinical benefit.      Aim 2: To investigate the potential value of a novel biomarker of LAM, quantitative     measurement of the number of TSC2 mutant LAM cells per ml of blood, to assess disease     severity.   "
61189|NCT02484651|"     The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular     block throughout the entire surgical procedure followed by sugammadex reversal, would     suppress EMG activity and result in improved anesthetic stability by reducing the variability     of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the     anesthetic drugs propofol and remifentanil required to maintain an adequate level of     anesthesia (BIS between 40 and 60).   "
61190|NCT02484638|"     The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety     of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of     age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study     consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to     evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the     PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and     Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2     (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the     best efficacy and safety in stopping acute bleeding events (this dose will be called the     population best dose). The purpose of the final Part 3 (Repeated-dose part) is to confirm     the efficacy and safety of the population best dose identified in Part 2. In Parts 2 and 3,     subjects will self-administer a specified number of CSL689 infusions at home on-demand (ie,     when a bleeding event occurs), will keep an electronic diary, and will visit the center at     monthly intervals. This study is expected to last for up to 16 months for the subjects     participating in all 3 parts, and up to 9 months for the subjects participating in Part 3     only.   "
61191|NCT02484625|"     Dairy products have a potential to be healthy snack foods for children and are provided in a     variety of food matrices. For instance, milk represents a fluid product, yogurt can be     classified as a semi-solid food, and finally cheese is the example of the solid food. This     experiment is aimed to examine the effect of dairy products with different food matrices on     satiety and food intake in children. Dairy products will be compared with other non-dairy     snacks popular among children including cookies and potato chips.   "
61192|NCT02484612|"     Acute exercise has been shown to affect subsequent energy intake in obese adolescents.     Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the     individual maximal capacities) can reduce energy intake at the following meal in obese     adolescents, with no modification of his appetite feelings.      Although this results has been replicated several times, it remains unknown if those     nutritional adaptations are due to post-exercise modifications of some gastro-peptides     implicated in appetite control, as detailed in adults.      The aim of this work is to question whether or not post-exercise energy intake is explained     by appetite-regulating hormones that are affected by the exercise bout in both lean and obese     youth.   "
61194|NCT02484586|"     The aim of this study is to assess the visual performance of multiple optimised prototype     soft contact lens designs compared to commercially available contact lenses.   "
61196|NCT02484560|"     Duchenne Muscular Dystrophy (DMD) is a X-linked genetic disorder primarily affecting males,     resulting in an absence of dystrophin which ultimately leads to progressive muscle     degeneration. Patients with DMD progressively lose functional abilities of movement, breath,     and eventually the ability to circulate blood. Currently, there is no cure for DMD, although     several strategies are being tested for treatment, none have yet proven to be sufficient.     Children with DMD are generally divided into two groups based on severity or progression of     the disease, non-ambulatory and ambulatory. Ambulatory patients are capable of walking     independently while non-ambulatory patients cannot walk independently.   "
61197|NCT02484547|"     The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab     in slowing cognitive and functional impairment as measured by changes in the Clinical     Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with     early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as     compared with placebo on clinical progression as measured by Mini-Mental State Examination     (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative     Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)     [ADCS-ADL-MCI].   "
61198|NCT02484534|"     Cirrhotic patients are patients with high morbidity and mortality, it is very important for     determining the prognosis of these patients. The importance increases when these patients     waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable     measure of mortality risk in patients with end-stage liver disease. It is used as a disease     severity index to help prioritize allocation of organs for transplant. MELD uses the patient     values for serum bilirubin, serum creatinine, and the international normalized ratio for     prothrombin time (INR) to predict survival.      Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT)     do not check actually the functioning of the system, but examine the level of clotting     factors and therefore only verify that the side of Anticoagulant of the equation and not the     side of the procoagulant .      To examine the coagulation system function tests have been developed, One of them is the     thrombin generation. The purpose of the trial is to determine whether thrombin generation     test can be a prognostic indicator in patients cirrhosis.   "
61199|NCT02484521|"     PPI is an objective measure to assess pre-attentive processes that have already been tested     before in the case of schizophrenia. The investigators aim to assess through this instrument     two main characteristics, that the investigators assume are of relevance which are the     duration of illness and the type of pharmaceutical treatment, patients receive.      The investigators believe these two main characteristics are critical to the ability of the     patients in improvement of their PPI response to startle reflex.   "
61200|NCT02484508|"     Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have     inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the     symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid     patients.      To further verify the clinical effect of Guli capsule in the treatment of knee     osteoarthritis, the investigators perform this multi-center clinical study.   "
61201|NCT02484495|"     The purpose of the study is to evaluate the impact of a package of interventions including     production and distribution of locally produced complementary foods (via so-called     Grain-banks) and Micronutrient Powders (MNPs) supplementation, and optimized food based     Complementary Feeding Recommendation, on growth and micronutrient status of infants and young     children. The impact of the intervention package will be evaluated in a quasi-experimental     matched-control cluster design in infants and young children between 6 - 29 months of age.     The impact, outcome, and output indicators of infants/children will be assessed in     cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair clusters are     selected in which 15 households per cluster will be identified from the eligible population.     A total of 1800 children from intervention and match-controlled clusters, will be sampled in     the target age groups. Qualitative and quantitative data will be collected to gather     information on Knowledge, Attitude and Practice (KAP), Infant and Young Child Feeding     practices, anthropometry and anemia, following the impact pathway developed for the study.      Research questions to be answered in this program evaluation are:        1. What impact does the extended pilot (implementation of local complementary food          production and MNP) have on:             1. Growth in children 17-29 months of age             2. Infant and Young Child Feeding practices in children (6-23m), and             3. Anemia status in children 11-23 m?        2. What are determining factors for the impact/no impact related to:             1. Immediate outcomes: skills and capacity; knowledge, attitude and practices; and               improved access             2. Intermediate outcomes: utilization; provision, and ensuring enabling environment             3. Program performance as measured by program monitoring data on output and               activities?   "
61202|NCT02484482|"     The purpose this study investigate the effect of food on the     pharmacokinetics/pharmacodynamics and safety of CKD-519   "
61203|NCT02484469|"     Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small group     active learning in large group educational settings. When TBL is conducted correctly, the     students' performances are equivalent or improved in comparison to either lecture-based     formats or more traditional small group learning models.1 Nevertheless, few studies have been     published regarding the insertion of innovative audiovisual tools in the TBL context. The     Virtual Human Project is described as powerful sequences of three dimension (3D) computer     graphics video of the human body that aids learning by facilitating an understanding in     relation to a specific subject. The Virtual Human is composed by video sequences combining     anatomy, physiology, and morphology in the context of various diseases. There are video     sequences available for many disciplines, including dermatology and with capacity to produce     anatomical structures by 3D printer. Despite the incredible potential applications of the     Virtual Human, few studies have assessed its impact on medical education. The investigators     did not find any study evaluating TBL with the insertion of iconographic educational material     that assessed whether this intervention could change the learning progress of students. This     is the aim of the present study, by comparing students tests scores after a TBL session with     the VIrtual Human videos about leprosy or a standard TBL session, and to evaluate the     student's satisfaction with the Virtual Human videos.   "
61213|NCT02484339|"     Phase II open-label study to evaluate the efficacy and safety of Radium-223 dichloride in     combination with external beam radiotherapy (EBRT) vs. external beam radiotherapy alone in     the treatment of advanced castration resistant prostate carcinoma with limited bone     metastases.      To evaluate if time to radiological progression according to the Recommendations of the     Prostate Cancer Clinical Trials Working Group published by Scher et al. (JCO 2008) (based on     new lesions in bone scan and CT /MRI or death) of Radium-223 dichloride combined with EBRT is     superior compared to EBRT alone.   "
61214|NCT02484326|"     The purpose of this study is to validate a practical risk score to predict the mechanical     complication of ST-elevation myocardial infarction (STEMI).   "
61204|NCT02484456|"     Background:      - Drugs and talk therapy help treat depression, but these treatments usually take quite a bit     of time to work. Ketamine is a fast-acting antidepressant, but it has side effects like     unusual dreams and experiences. The drug AV-101 may have the same antidepressant effects but     fewer side effects. Researchers want to see if it is effective and safe for people with major     depressive disorder.      Objective:      - To see if the drug, AV-101 is safe and if it treats symptoms of major depressive disorder.      Eligibility:      - Adults ages 18 65 with major depression without psychotic features.      Design:        -  Participants will be screened under a separate protocol.        -  Participants will stay in the hospital for 12 14 weeks.        -  Phase 1 (2 7 weeks): participants will stop taking their medicines then not take any for          2 weeks. They will have several scans and other procedures.        -  Phase 2 (6 7 weeks): 2 weeks each of study drug and placebo once a day, with 2 weeks of          no drugs in between.        -  Participants will have:        -  Physical exams        -  Interviews        -  Frequent blood collection. A needle will place a small plastic tube in the arm. Some          blood samples will be taken through this tube.        -  2 spinal taps (optional). The back will be numbed. A needle will insert a catheter          between back bones. That will be left in for up to 30 hours. Spinal fluid will be          collected through it.        -  5 scans. Participants will lie in a machine with a magnetic field. The machine takes          pictures of the brain and brain chemicals.        -  At the end of the study, participants will have medical evaluation, questions, and blood          tests. Some may continue treatment at the clinic.   "
61207|NCT02484417|"     Background:      - Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be     life-threatening, especially in young children, the elderly, and people with weak immune     systems. Researchers want to study RSV infection in a hospital setting in healthy adults.     They want to use what they learn to test new treatments or vaccines in the future.      Objectives:      - To study how the body responds to RSV.      Eligibility:      - Healthy volunteers ages 18-50      Design:        -  Participants will be screened under another protocol.        -  Participants will have:        -  Medical history        -  Physical exams        -  EKG. Heart rhythm is measured with small sticky patches on the chest, arms, and legs.        -  Chest x-ray        -  Pulmonary function tests. This measures how much air a person can move into and out of          the lungs.        -  Blood and urine tests        -  Nasal washes and/or nasal swabs. For the wash, the nose will be rinsed with a sterile          liquid. For the swab, the inside of the nostril will be rubbed with a cotton swab.        -  Participants will have two, possibly three, follow-up outpatient visits, approximately          1, 2 and 6 months after receiving the dose of RSV.        -  Participants will stay in the hospital under isolation for 7 or more days after getting          the virus.        -  The average stay is 10 days. Participants cannot leave the isolation unit. They cannot          have visitors.        -  The virus should cause a mild to medium cold.        -  Participants will fill out a symptom card every day in the hospital and for 1 month          after.        -  Participants will have 2 follow-up visits, 28 and 56 days after leaving the hospital.        -  Female participants who are sexually active must remain abstinent or use an effective          form of birth control for 1 month before and after getting the virus.   "
61208|NCT02484404|"     Background:      - MEDI4736 is a drug that may help people s immune systems respond to and kill cancer cells.     Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug     that may stop the blood vessel growth of cancer cells. This study has two components. In the     phase 1 component of the study, researchers want to investigate how well participants     tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2     part of this study, researchers want to study if the combination treatments are effective in     ovarian cancer.      Objectives:        -  Phase 1 part of the study: To determine the safety of the combination of MEDI4736 with          the drugs olaparib or cediranib.        -  Phase 2 part of the study: To determine how effective this combination is in treating          ovarian cancer.      Eligibility:        -  Phase 1 part of the study: Adults age 18 or older with advanced or recurrent solid          tumors that have no standard treatment.        -  Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian          cancer that has no standard treatment.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests. They will have CT or MRI scans. For these, they will lie in a machine that takes          pictures of their bodies.        -  Phase 2 part of the study requests the participants to have tumor samples removed.        -  Participants will get MEDI4636 through an IV. A small plastic tube will be inserted into          a vein. The drug will be given every 2 weeks for 12 months.        -  Participants will take olaparib or cediranib by mouth every day.        -  Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All          other cycles, they will have 1 visit. At these visits, they will repeat the screening          procedures.        -  Patients will keep a drug and diarrhea diary.        -  Patients on cediranib will monitor their blood pressure and keep a blood pressure diary.        -  Participants who can become pregnant, or have a partner who can become pregnant, must          practice an effective form of birth control.        -  After 12 cycles, participants will have 1-3 months of follow-up.   "
61209|NCT02484391|"     This pilot phase II trial studies how well CPI-613 (6,8-bis[benzylthio]octanoic acid),     cytarabine, and mitoxantrone hydrochloride work in treating patients with acute myeloid     leukemia or granulocytic sarcoma (a malignant, green-colored tumor of myeloid cells [a type     of immature white blood cell]) that has returned (relapsed) or that does not respond to     treatment (refractory). 6,8-bis(benzylthio)octanoic acid is thought to kill cancer cells by     turning off their mitochondria. Mitochondria are used by cancer cells to produce energy and     are the building blocks needed to make more cancer cells. By shutting off these mitochondria,     6,8-bis(benzylthio)octanoic acid deprives the cancer cells of energy and other supplies that     they need to survive and grow in the body. Drugs used in chemotherapy, such as cytarabine and     mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving 6,8-bis(benzylthio)octanoic acid together with cytarabine and mitoxantrone     hydrochloride may kill more cancer cells.   "
61210|NCT02484378|"     The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER     001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as     measured by coronary IVUS, when administered to subjects presenting with Acute Coronary     Syndrome (ACS) with significant plaque volume.   "
61211|NCT02484365|"     The preoperative evaluation including sampling blood in pediatric patients is hard to     perform. However, the knowledge of the baseline cell blood count is important to prepare     unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small     children is often failed and sometimes induces iatrogenic blood loss and parent's complaints.     The Pulse Co-oximetry (Masimo) is recently developed device which can provide noninvasive     hemoglobin value. However, the accuracy is controversial. There are studies in pediatric     patients during surgery and in ICU. However, the comparison for preoperative evaluation is     not analysed. Therefore, the investigators want to evaluate the accuracy for preoperative     preparation in pediatric patients.   "
61212|NCT02484352|"     Intravenous form of oxycodone is recently used for the adjunct of anesthetic agents to avoid     adverse effects of the stimulation of endotracheal intubation. The potency ratio of oxycodone     to fentanyl is not absolutely defined. The aim of this study was to assess the optimal dose     of intravenous oxycodone for attenuation of hemodynamic responses to laryngoscopy and     endotracheal intubation.      A prospective, randomized, double-blind study was conducted. Ninety one patients were     randomly divided into 5 group based on the dose of oxycodone; 0, 0.05, 0.1, 0.15, 0.2 mg/kg.     After giving each assigned dose of intravenous oxycodone, anesthesia was induced with     thiopental and rocuronium. Heart rate (HR) and blood pressure (BP) was collected at baseline,     before intubation, 1, 2, 3 minutes after intubation. The change of BP was calculated by     (highest BP after intubation - baseline BP)/baseline BP.   "
61215|NCT02484313|"     Dairy products have a potential to be healthy snack foods for children. The purpose of this     project is to investigate the short-term effects of Greek yogurt, a new popular dairy product     on the regulation of glucose homeostasis, satiety and energy intake in normal weight and     overweight/obese children.   "
61320|NCT02482935|"     The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood     stream and how long the body takes to get rid of it when given with and without food. In     addition, the safety and tolerability of the study drug will be evaluated. Information about     any side effects that may occur will also be collected. The study will last about 43 days for     each participant, not including screening.   "
61216|NCT02484300|"     Our hypothesis is that oxidative stress induced during repeated apneas in obstructive sleep     apnea (OSA) patients alters the neural control of breathing which destabilizes ventilatory     control and exacerbates OSA. Thus antioxidant treatment has the potential to reduce OSA     severity. Melatonin is a hormone which regulates sleep patterns, but it is also a potent     antioxidant. Melatonin production is suppressed when the eyes register light so people with     healthy sleep exhibit a peak in blood serum levels around 2am which then decreases towards     morning. OSA patients exhibit lower melatonin levels with a later peak around 6am which then     extends later into the day. This abnormal pattern is thought to compound difficulty falling     asleep and daytime mental fatigue. Therefore the potential benefits of melatonin treatment in     OSA patients are two-fold: most importantly via its antioxidant actions melatonin may reduce     chemoreflex sensitivity, stabilize ventilatory control and reduce OSA severity; by     normalizing sleep phase melatonin may also allow patients to fall asleep easier and wake more     refreshed.   "
61217|NCT02484287|"     The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD)     related catheter infections by comparing the efficacy of Oklahoma University Medicine     standard EVD catheters, both impregnated and non-impregnated, in three principle areas:     incidence of infection, cost analysis, and average durations of placement, all while     maintaining the standards of technique.   "
61218|NCT02484274|"     ID in children is the most frequent micronutrient deficiency in industrialized countries,     including France. ID induces neurological impairment reducing cognitive, motor, and     behavioral capacities in children in the short and long term.      The purpose of this study is to evaluate the principal determinants of ID in France in     two-year-old children and to improve strategies for prevention and screening.      Our main objective is to study the association between iron status in two-year-old infants     living in France and the consumption of toddler milk formula after taking non-dairy iron     ingestion, parental socioeconomic status and educational level into account.      Our secondary objectives are the following :        -  to estimate the prevalence of ID and ID anemia in 2-year-old children living in France.        -  to improve clinical tools for ID screening. to improve strategies for laboratory          screening.   "
61219|NCT02484261|"     This study aims to monitor patients for relapse of the leukemia following allogeneic     Hematopoietic Stem Cell Transplantation (HSCT) in order to identify patients early in     relapse, with a low burden of disease, when interventions may be more successful by     monitoring of peripheral blood lineage specific chimerism. Once disease has been confirmed,     patients will initiate a novel combination of bortezomib and pravastatin.   "
61220|NCT02484248|"     This study is a double-blind, placebo -controlled, cross-over trial of ketotifen in children     ages 8 through 17 inclusive that have a diagnosis of Functional Dyspepsia and have had     continued pain despite acid reduction therapy in combination with montelukast. This study is     147 days for subjects responsive to the ketotifen and 63 days for those who are not. The     study includes scheduled visits including a physical, blood draws, and questionaires.   "
61221|NCT02484235|"     Obesity is a global health problem since it is associated with many cardiovascular and     metabolic diseases, osteoarticular problems and some cancers. That is why it is a priority of     the national health policies. Exercise is a mainstay in the treatment, but still the most     effective method is sought. The resistance exercise and high intensity intervals (HIIT) have     been shown to positively affect the outcome of the disease, increasing the oxidative capacity     of the trained subjects. Therefore it is important to look if both together produce greater     benefits or otherwise nullify its effects, such as suggested by recent publications in     relation to the cellular response to different stimuli such exercise in skeletal muscle. The     aim of this study is to evaluate the effectiveness of interventions exercise high intensity     intervals, overload and combining them in the oxidative capacity of obese subjects.   "
61222|NCT02484222|"     The purpose of this study is to discuss the relationship between the result of fentanyl test     and required dosage of morphine for children with OSAS after adenotonsillectomy；and to     evaluate the ability of predicting requested dosage of morphine postoperatively.   "
61223|NCT02484209|"     1. Many patients with type 2 diabetes are not at glycaemic goal and require additional          therapy in order to reduce vascular risk and improve symptom control        2. Sulphonylurea therapy is a commonly prescribed 2nd-line glucose -lowering agent and its          use is recommended in major clinical guidelines for diabetes and also in the recently          presented IDF (International Diabetes Federation) guidelines for older people.        3. Older people with diabetes are not a homogeneous group and as many as 25% are frail.        4. Frailty is a PRE-DISABILITY state but may increase the 'vulnerability' of many older          people to having a fall, admission into hospital, or perhaps increasing their risk of          hypoglycaemia        5. As a consequence of their glucose-lowering ability, sulphonylureas may increase the risk          of hypoglycaemia in older people and those who have features of frailty may be at          increased risk.        6. The investigators therefore need to estimate the risk of hypoglycaemia in moderately          frail older subjects with type 2 diabetes who are taking sulphonylurea therapy as this          is a commonly prescribed class of agent used routinely in clinical practice        7. Thus, this short term project wishes to assess the frequency of hypoglycaemia in          subjects with some evidence of frailty with type 2 diabetes by a series of glucose          monitoring techniques with excellent research team support to minimize any safety          issues. An identical study at the Second University of Naples, Italy under the          supervision of Professor Giuseppe Paolisso is planned and is the second study site for          this PILOT project.   "
61356|NCT02482467|"     Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not     described to date.   "
61224|NCT02484196|"     Endometriosis is a disease that affects different areas of individual functioning, including     the area of sexual life. Women with endometriosis have an impairment of desire and sexual     arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the     study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis,     taking into account other variables involved in determining dyspareunia: the quality of the     couple relationship, anxiety and depression, body image, coping strategies and resilience.   "
61330|NCT02482805|"     The purpose of this study is to determine whether power posing (i.e., holding poses     associated with dominance and power), compared to submissive posing or rest, prior to     exposure therapy for social anxiety disorder: 1) leads to a temporary increase in     testosterone levels and/or 2) facilitates exposure therapy outcomes.   "
61225|NCT02484183|"     Pneumonia mortality rates in African countries like Malawi are high and increased further in     children -exposed or infected with human immunodeficiency virus (HIV) as well as those that     are severely malnourished or severely hypoxemic. Treatment innovations are needed. Bubble     continuous positive airway pressure (bCPAP) improves oxygenation and ventilation and is a     simple, relatively inexpensive adaptation of conventional continuous positive airway pressure     potentially suitable for low-resource settings. bCPAP has been demonstrated to improve     outcomes in neonates less than 1 month of age. Recently, a limited number of hospitals are     using bCPAP to escalate pneumonia care for older African children failing standard treatment     with antibiotics and oxygen. Supportive evidence for this approach is observational only.     Quality randomized studies comparing bCPAP versus a standard-of-care control group that     includes low-flow oxygen therapy and using a primary endpoint of mortality are not available     in low-resource settings including high prevalence HIV countries like Malawi. Demonstrating a     mortality benefit with bCPAP is needed to support further investment and scale up of bCPAP in     the care of older Malawian children 1-59 months of age with World Health Organization (WHO)     severe pneumonia complicated by HIV and/or malnutrition or severe hypoxemia.      With the full support of the Malawi Ministry of Health and in collaboration with external     experts from Lilongwe Medical Relief Trust and Cincinnati Children's Hospital Medical Center     investigators plan to address this critical evidence gap by conducting a randomized     controlled study determining bCPAP outcomes, compared to the currently recommended standard     of care endorsed by the WHO and Malawi national pneumonia guidelines, in hospitalized     Malawian children with WHO-defined severe pneumonia complicated by a co-morbidity ((1)     HIV-infection, (2) HIV-exposure without infection, (3) severely malnourished) or WHO     pneumonia with severe hypoxemia and without a co-morbidity. The investigators hypothesize     that bCPAP will reduce the mortality of Malawian children with WHO-defined severe pneumonia.   "
61226|NCT02484170|"     30% mannitol cream has shown its ability to reduce the activation of the Capsaicin (TRPV1)     (Transient Receptor Potential Vanilloid 1) receptor, a likely cause of the pain of     post-herpetic neuralgia (PHN). This randomized placebo-controlled crossover study compares     PHN pain one week before, for one week on the randomly assigned mannitol versus placebo cream     and, after a three day washout, for one week on the other cream. Following this crossover     study, participants receive mannitol cream for three months, and ,on request, for a further 9     months. Pain levels will be checked to assess whether continued use of this cream     significantly reduces the pain levels associated with PHN.   "
61227|NCT02484157|"     This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus).   "
61228|NCT02484144|"     French study, multicentrique with the cooperation of several hospital centers . 700 patients     (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a     anonymous way.   "
61229|NCT02484131|"     The purpose of this study is to test the feasibility of the study protocol. The study     protocol was designed to evaluate questions - Do educational materials improve dual x-ray     absorptiometry (DXA) screening rates for women diagnosed with breast cancer and Does     educational materials delivered by the participant's selected choice change DXA screening     rates compared to the conventional mail method?.   "
61230|NCT02484118|"     The study purpose is to determine whether two different hemodialysis blood flow rates each     meet national dialysis standards for urea clearance. Urea is used as the primary marker of     dialysis adequacy. It is an experimental study with a crossover design of minimum 38     participants. Participants will be selected from the accessible pool of end-stage renal     disease clients at the Vancouver Community Dialysis Unit. The participants will dialyse at     each pre-determined blood flow rate (320 mL/min and 380 mL/min) for two weeks each. Two forms     of urea clearance data will be collected: one value that is routinely calculated by the     dialysis machine and recorded on client treatment logs, and another that is calculated in a     lab from blood samples.   "
61231|NCT02484105|"     Does comforting conversation during colonoscopy improve on patient satisfaction, compliance     and pain management.   "
61232|NCT02484092|"     A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with     Hemophilia B.   "
61233|NCT02484079|"     This study aims to investigate the comparative effectiveness between polyp removal with or     without electrical current. The investigators want to include 800 polyps in the trial.      It is known that polyps have the potential to develop to cancer if left in situ, but the     investigators do not know the best way to remove them completely.   "
61234|NCT02484066|"     The purpose of this study is to evaluate the feasibility, efficacy and safety of     transbronchial biopsy (TBB) and bronchial brushing by using virtual bronchoscopic navigation     (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) for the diagnosis     of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.   "
61235|NCT02484053|"     Rituximab is frequently used in adult and pediatric cancers, blood disorders, lymphoma (a     cancerous growth made up of lymphoid tissue), graft-versus-host-disease (complication that     can occur after a stem cell or bone marrow transplant), diseases of the immune system (the     cells and substances that protect the body from infection) and rheumatologic conditions.     Rituximab works by decreasing or temporarily eliminating a specific type of white blood cell,     the B-lymphocyte. Overall, rituximab is generally well tolerated. The likelihood of an     infusion-related reaction, or symptoms such as fever, chills, hives, low blood pressure or     swelling, is very low, but highest during a patient's first infusion of rituximab and     decreases with each additional dose. Adults commonly receive rituximab at a faster rate if     they have done well with the first infusion, this study will help determine if the same     approach is well tolerated in children.      In this study, the investigators are testing a new method of administering rituximab which     may reduce the time it takes to receive the medication. The initial ordered amount of     rituximab will not change from the current standard of care (meaning what is usually done by     doctors, and would likely be done if you were not on this study). The period of time over     which rituximab is given is what is being studied.   "
61236|NCT02484040|"     The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral     capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and     leucovorin) in this randomized trial.   "
61260|NCT02483715|"     Up to now, there is few randomized, large scale study prospectively and simultaneously     comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy     (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori     eradication.      The aims of this study are:        1. to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication;        2. to compare the patient adherence and adverse effects of these treatment regimens;        3. to investigate factors that may influence H. pylori eradication by these treatment          regimens.   "
61331|NCT02482792|"     The aim is to examine the effect of Norwegian Psychomotor Physiotherapy (NPMP) in employees     with long-lasting musculoskeletal pain compared to employees receiving Cognitive Patient     Education in combination with active individual physiotherapy (COPE-PT) on pain, function,     quality of life and sick-leave   "
61237|NCT02484027|"     This study is randomized, open-lable, parallel-group and comparator-controlled. 456     consecutive patients with acute ischemic stroke admitted within the first 72 hours after     onset of symptoms will be studied. Those patients who will be randomly assigned to receive 2     different treatment for the first 3 days of hospitalization(non-statin-therapy group) or to     immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From     the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients. The     total trial will be continued 12 months.      mRS will be investigated at baseline, 3rd month, 12th month ;MMSE and Montreal tests will be     investigated at baseline and 12th month. Laboratory data including serum lipids, Fg and     hs-CRP.Among these, serum lipids will be tested at baseline, 8th day, 3rd month, 6th     month,and 12th month; hs-CRP will be tested at baseline and 8th day, 3rd month; Fg will be     tested at baseline, 8th day, 3rd month. Safety will be also assessed by adverse event reports     and clinical laboratory data including CK-MB, renal and hepatic function at 3rd month, 6th     month,12th month.   "
61238|NCT02484014|"     SEHER- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent     health, seeks to develop and evaluate a school based adolescent health promotion intervention     delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school     counsellor called as SEHER Mitra (SM) in government-run secondary schools in Bihar, India.     SEHER will implement a three armed clustered randomised trial (CRT) to evaluate the     effectiveness and cost-effectiveness of these two models compared with the Tarang-Adolescence     Education Programme (usual care) implemented by the State Government of Bihar. The hypothesis     is that both interventions, compared to the control arm, will lead to a greater impact on     school climate (school connectedness and relationship with teachers and fellow students). In     addition, the interventions will increase the knowledge, attitude and awareness, and     promoting healthy behaviours in youth on reproductive and sexual health outcomes, mental     health and substance use, and gender related attitudes and violence. It is hypothesized that     the addition of more resource intensive component (the SM arm) will be associated with the     best outcomes.   "
61239|NCT02484001|"     This is a Phase III, multinational, open-label, non-controlled study with subjects under     treatment in the double-blind BIA-2093-311 study (NCT01162460).      Subjects will enter the open-label extension study after the preceding double-blind study was     unblinded and they are attending their last Extension Phase Visit (EPV) of the double-blind     study.      For all subjects, the day of the last EPV of the double-blind study will also be the day of     Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine acetate     (ESL) under open-label conditions at Visit 1.      The complete study duration including treatment with ESL under open-label conditions and     follow-up is expected to last approximately 2 years (105 weeks).      In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be     discontinued prematurely within 42 days after achievement of MA.   "
61240|NCT02483975|"     Inhaled corticosteroids (ICS) have a number of known class effects including     hypothalamic-pituitary-adrenocortical (HPA) axis suppression. Although the safety of inhaled     Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has been     established, it is important to assess the risk of suppression in children so as to establish     whether this medicine can be safely used in this young population. This study aims to     evaluate the effect of inhaled FF on the HPA axis of children 5-11 years of age (inclusive)     with persistent asthma compared with placebo. Approximately 143 subjects will be enrolled.     Subjects will enter a 7 to 14 day run-in period on oral montelukast 4 milligrams (mg) (5 year     old subjects) or 5 mg (6-11 year old subjects) once daily. Eligible subjects will be     randomized to receive once-daily FF inhalation powder 50 micrograms (mcg) or once-daily     placebo inhalation powder in the morning via the ELLIPTA™ inhaler for 42 days. Subjects will     continue to receive open label montelukast during the treatment period. All subjects will be     provided albuterol/salbutamol inhalation aerosol, to use as needed to treat acute asthma     symptoms throughout the study.      ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.   "
61241|NCT02483962|"     Chronic Venous Insufficiency (CVI) occurs when the veins in the lower limbs can no longer     sufficiently pump enough blood back to the heart. Symptoms may include: dull aching,     cramping, itching or tingling in the calves, swelling, redness or any colour changes as well     as thickening of the skin in the lower limbs. The most common indication of CVI is dilated     veins known as varicose veins. CVI is a disorder found more commonly in females. Conventional     treatments for CVI include vein ligation or stripping, elastic compression, valve     reconstruction and sclerotherapy venous bypass. Amongst other treatment, exercise has also     proven to be effective in improving CVI as it increases circulation, by increasing blood     returning to the heart. A variety of herbal supplements have been proven to be safe and     effective in the treatment of CVI. Red vine leaf extract has also been proven to be useful in     the treatment of CVI. Previous studies on the red vine leaf extract have shown that it is an     effective and safe treatment of CVI. Studies done on horse chestnut extract have stated that     the extract increases venous tone and decreases capillary permeability. Butcher's broom     extract has been proven to be effective in the treatment of CVI. There are currently no     studies done on the combination of red vine leaf extract, butcher's broom extract, horse     chestnut extract and vitamin B6.      The aim of this study is to determine the efficacy of a combination of red vine leaf extract     (360mg), horse chestnut extract (60mg), butcher's broom extract (35mg) and pyridoxine     (vitamin B6) (3.2mg) in the treatment of symptoms associated with CVI, using a Venous     Clinical Severity Score questionnaire (VCSS) .   "
61242|NCT02483949|"     To examine the effectiveness of a group-based lifestyle modification program followed by     peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk     reduction. The lifestyle modification program will support daily ambulatory activity and low     glycemic index food intake among women with previous gestational diabetes mellitus (GDM).   "
61243|NCT02483936|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drug associations in the essential hypertension control.   "
61244|NCT02483923|"     Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and     consumption of opioid after mastectomy.   "
62516|NCT02467335|"     A single oral dose study in subjects with hepatic impairment and healthy control subjects.     Subjects will stay at the clinical facility where interval blood samplings will be obtained     and examined for drug effect.   "
61246|NCT02483897|"     Corneal abrasions are associated with significant discomfort during a 24-48 hrs healing     phase. Current practice guidelines discourage the use of topical anesthetics in treating     these patients due to concerns that these medications may prevent proper corneal epithelial     healing. These concerns are based primarily on decades old animal based research. However,     recent evidence suggests topical anaesthetics are a safe and effective way of managing     patient pain in the short term. This study will investigate the effect of topical 0.5%     tetracaine on corneal healing and pain management in patients with corneal abrasions in the     first 48 hours.      This will be a prospective, double blind, randomized, controlled study of 260 adults with     uncomplicated acute corneal injuries presenting to the tertiary acute care settings in     Kingston. Patients will be randomly assigned to receive either 0.5% tetracaine or saline in     addition to usual care as outpatients. They will be followed through the ophthalmology     emergency eye clinic to assess healing at 36-48hrs. after the acute care visit. The primary     outcome will be an assessment of pain as measured every 4 hours for 48 hrs. using a 10mm     Visual Analogue Scale (VAS). Secondary outcomes will include assessments of corneal healing,     use of adjunct pain medications, time lost from work/usual activities, quality of sleep,     ability to read and the SF12 quality of life questionnaire.      This study will better inform the safety and effectiveness of short-term tetracaine usage in     patients with simple corneal abrasions for optimal treatment of patients in the future.   "
61247|NCT02483884|"     The aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled     PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer confirmed by     histopathology of the prostate as a standard of truth.      This is an open-label, multi center PET/CT (positron emission tomography/computed tomography)     non-randomized study. The study comprises 2 parts with an interim analysis after Part 1. In     Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be enrolled.     Three strata of patients for the first part will be enrolled based on their pretreatment     recurrence risk assessment according to the NCCN guidelines: 10 patients with low, 10     patients with intermediate and 10 patients with high pretreatment risk of recurrence.   "
61248|NCT02483871|"     Patients will be treated in a dose escalation scheme to investigate a role for the addition     of a statin in the treatment of estrogen receptor positive breast cancer. Patients will take     oral rosuvastatin daily. The maximum number of patients evaluable for a DLT is 12. Dosing     will be as follows: Cohort 1 - rosuvastatin 20mg, Cohort 2 - rosuvastatin 40mg. The patients     will have a total of 4 blood draws and 4 breast biopsies. The breast biopsies will be     collected to evaluate cholesterol metabolites and tumor microenvironment characteristics     including gene expression profiling and metabolomics. Sampling will occur at study entry,     week 4, week 8, and at the time of surgery in early stage patients or at week 16 for     metastatic patients. Patients will begin endocrine therapy following the acquisition of week     4 samples (blood and tissue biopsy).   "
61249|NCT02483858|"     This is an open-label, multi-center, non-randomized, dose escalation Phase 1 study evaluating     safety, tolerability, PK (pharmacokinetics) and efficacy of PQR309 in the treatment of     selected patients with advanced solid tumors.   "
61250|NCT02483845|"     Muscle biopsies of patients with Inclusion Body Myositis (IBM) have demonstrated a T-cell     predominant inflammatory infiltrate, therefore, new agents targeting T -cell mediated cell     death may be a novel treatment for IBM. Such an agent capable of preventing T-cell movement     out of the vasculature, such as natalizumab, may be beneficial in IBM patients. Six patients     will be recruited to participate in this phase I trial.   "
61251|NCT02483832|"     The main purpose of this study is to promote colorectal cancer (CRC) screening among     individuals who have never been screened, with these individuals being members of a panel who     participant in online studies. The primary study goals are to test effects of the matching     between level of comparative risk feedback for colorectal cancer (CDC), that is, how one's     risk compares to others, and message framing (Gain vs. loss frame) on CRC screening     intentions and screening as well as mediators of effects in the context of people who obtain     CRC risk feedback and framing messages online (i.e., Internet).   "
61252|NCT02483819|"     The purpose of this study is to evaluate the change of the hemodynamic profiles on bio     reactance technique during TURP in elderly patients.   "
61253|NCT02483806|"     One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary     shunt can be increased resulting hypoxemia. Wang et al measured intrapulmonary shunt by     transesophageal echocardiography. Although OLV technique had been advanced so far, hypoxemia     during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Applying     PEEP(Positive End-expiratory Pressure) at dependent lung and CPAP at non-dependent lung can     mitigate the hypoxemia. Above all, PEEP can be easily applicable. However, there are     controversial studies whether it is supportive or not. In this prospective, cross-over study,     the investigators are planning to investigate the effects of PEEP on intrapulmonary shunt,     oxygenation and cardiac function as well.   "
61254|NCT02483793|"     The primary objective of this study is to evaluate the efficacy and safety tamsulosin in     reducing stent discomfort in the pediatric population in the peri-operative period. The     secondary objective is to compare the efficacy of tamsulosin with that of oxybutynin in     reducing stent discomfort.   "
61255|NCT02483780|"     The proposed pilot community-based research project will examine the feasibility,     acceptability, and potential efficacy of the Storytelling intervention compared with usual     care in hypertension control among rural residents in 4 communities in Vietnam. This is a     major clinical and public health problem in this developing country.   "
61256|NCT02483767|"     The study is a prospective randomized control clinical trial which is sponsored by the     researchers. The purpose of this study is to determine the effectiveness of     Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer     patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1)     enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group)     or standard chemotherapy without goserelin (chemotherapy alone group). All patients are     stratified according to age (<35years vs.36-44years), hormone receptor status (HR+ or ER+     vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based     vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure,     follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and     disease-free and overall survival will be compared between two groups to evaluate the     effectiveness of protect against ovarian failure.   "
61261|NCT02483702|"     Blood transfusions are required for patients undergoing a craniosynostosis repair due to the     significant amount of blood loss. Irradiated or non-irradiated transfusions have many risks     involved including elevated potassium levels and graft versus host disease (TA-GVHD).     Irradiated blood is able to destroy the leukocytes responsible for TA-GVHD, but it adversely     causes elevated extracellular potassium due to hemolysis of the RBC's. When this blood is     transfused, it may introduce too much extracellular potassium (> 6.5 meq/L) into the patient     causing interference with the heart's conduction system significantly increasing the risk for     hemodynamic changes, cardiac arrhythmias, and cardiac arrest. Hyperkalemia from rapid     transfusions occurs much more frequently than TA-GVHD; however, both complications are     under-reported.      The study aims to evaluate the risk of irradiated versus non-irradiated blood in patients     under the age of 6 months undergoing a craniosynostosis repair. This will be done by     comparing the levels of extracellular potassium pre-transfusion, during transfusion,     immediately after transfusion, and 30 minutes after the completion of transfusion. The     investigators hypothesize that the patients who receive irradiated blood will have an     increased extracellular potassium level compared to those who receive non-irradiated blood.   "
61262|NCT02483689|"     Patient will have usual appendectomy surgery with an injection of local or saline at incision     site either before or after the incision at random.      The clinical hypothesis of this trial is that pediatric patients who undergo a local     anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain     and therefore reduce the amount of analgesics required to keep the patient satisfied.      Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess     the timing of local anesthetic injection affects postoperative pain.   "
61263|NCT02483676|"     Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient,     aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented     adaptive control system, this study tests whether robotic assisted treadmill training will     improve gait and balance functions in chronic stroke survivors with foot drop impairment. It     is hypothesized that, compared to treadmill training alone, integrating adaptive ankle     robotics with treadmill training will reduce drop foot during independent overground walking,     resulting in greater mobility, improved postural control, and reduced fall risk.   "
61264|NCT02483663|"     Scientists are examining the genetic and environmental influences on appetite and weight     gain. The main purpose of this study is to look at how genetic and environmental factors may     influence how the brain regulates appetite and food intake. Understanding how the brain     regulates appetite and food intake may eventually lead to new ways to help people avoid     obesity or lose weight.   "
61265|NCT02483650|"     The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world     patient outcome and side effect information from electronic health records submitted to a     specialty specific hyperbaric registry as part of Stage 2 of Meaningful Use, including data     provided to meet PQRS requirements via the registry's QCDR mission.      Goals include understanding the value of HBOT among patients treated for a variety of     conditions in relation to the frequency and severity of HBOT side effects. While randomized,     controlled trials can establish the efficacy of treatments like HBOT, because they routinely     exclude patients with co-morbid conditions common to those patients seen in usual clinical     practice, the results of RCTs are usually non-generalizable. Real world data can be used to     better understand the effectiveness of HBOT among typical patients, as well as the risks     associated with treatment.   "
61266|NCT02483637|"     This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic     bronchitis patients with airflow restrictions.   "
61267|NCT02483624|"     This is a single center study of patients with inactive or mild SLE being performed to     determine the safety, tolerability, and pharmacodynamics of DIM.   "
61268|NCT02483611|"     The magnesium sulfate and lidocaine have been increasingly used alone or in combination     during anesthesia procedure to meet various objectives, such as reduction of pain, use of     smaller anesthetic doses and stabilization of hemodynamic parameters.      These medicines are often used in combination with neuromuscular blocking agents, which may     contribute to the occurrence of residual block in some patients after anesthetic procedures.     It was estimated that only 1-3 % of patients with residual block developing clinically     apparent events. In a small proportion of patients, the consequences of residual blockade are     very serious and even lethal. It is estimated that 40 % of patients with muscle paralysis     come to the post-anesthesia care unit (PACU).      Considering that: (a) magnesium sulfate and lidocaine are showing an increasing number of     applications in various areas of medicine, (b) these medications stand out for their     properties analgesic, anti-inflammatory, anti-arrhythmic, neuroprotective and capable of     reducing the demand of anesthetics and opioids, (c) magnesium sulfate as lidocaine has been     important part of the therapeutic arsenal to control a large number of diseases (d) the     patient surgical surgery or potentially have benefited in particular from its effects, (and)     these drugs have been used routinely in many medical services as well as adjuvants in     anesthesia, (f) previous studies have shown that magnesium sulfate is able to prolong the     duration of neuromuscular blockade by different types of muscle relaxants, with controversies     about its effect on latency (g) the effect of lidocaine on the action of muscle relaxants in     current literature have shown great controversy and (h) do not exist in the literature     studies involving both drugs; the investigators aimed to investigate the effects of magnesium     sulphate infused alone or associated with lidocaine on the neuromuscular blockade promoted by     cisatracurium, as well as evaluate its possible hemodynamic repercussions. For this purpose     the SM was infused in bolus, prior to tracheal intubation and continuously during the     maintenance of general anesthesia; the Lidocaine, when associated and the Isotonic Solution     were used in the same way and timeline as SM. As secondary objectives it has been proposed to     evaluate if the Lidocaine with Magnesium Sulfate would be able to interfere with the     hemodynamic stability of the patients in the study.   "
61357|NCT02482454|"     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with     cholangiocarcinoma.   "
61269|NCT02483598|"     This study is to compare intestinal Cytochrome P450 3A4 (CYP3A4) activity in 9-18 month post     weight loss surgery Roux-en-Y Gastric Bypass (RYGB) versus control subjects who have not had     a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass     group. For this purpose, we will compare post-bariatric surgery patients with control     subjects on alterations in systemic exposure of buspirone, a CYP3A4 substrate, when     administered with grapefruit juice, a selective intestinal CYP3A4 inhibitor.   "
61270|NCT02483585|"     A Phase 3, Randomized, Double-blind, Placebo-controlled Study followed by open-label     treatment phase. To evaluate the effect of AMG 334 compared to placebo on the change from     baseline in monthly migraine days, in subjects with episodic migraine   "
61291|NCT02483312|"     This is a phase 1 study (the first stage in testing a new treatment to see how safe and     tolerable the treatment is) which will include patients with acute myeloid leukemia (AML)     that has either returned or has a more than a 70% chance of coming back and cannot have a     bone marrow transplant.      This study will see whether modifying a patient's AML cells to produce IL-12 and giving it     back to the patient is safe and useful in patients with AML that cannot have bone marrow     transplants.   "
61271|NCT02483572|"     Children with an intellectual disability often display severe destructive behavior (e.g.,     aggression, self-injury) that pose risks to themselves or others and represent barriers to     community integration. Destructive behaviors are often treated with behavioral interventions     derived from a functional analysis, which is used to identify the antecedents and     consequences that occasion and reinforce the destructive behavior. One treatment is called     functional communication training (FCT), which involves extinction of destructive behavior     and reinforcement of an alternative communication response with the consequence that     previously reinforced destructive behavior. Results from epidemiological studies and     meta-analyses indicate that treatments based on functional analysis, like FCT, typically     reduce destructive behavior by 90% or more and are more effective than other treatments.     However, many if not all of these studies have used within-subject experimental designs to     demonstrate control of the treatment effects. Replication of the effects of FCT is typically     shown on a subject-by-subject basis with relatively small numbers of patients (e.g., one to     four patients). No study has demonstrated the effectiveness of FCT for treatment of     destructive behavior across a large group of children.      The goal of this study is to compare FCT (which is used clinically with the majority of the     investigators' patients and is considered best practice for treating destructive behavior     that occurs for social reasons [e.g., to access attention, preferred toys, or to escape from     unpleasant activities]) to a waitlist control group across a large number of children with     destructive behavior to evaluate the generality of FCT effectiveness. The investigators will     evaluate rates of destructive behavior with each patient during a pretest baseline and again     following FCT (approximately four months later) and/or the waitlist control duration (again,     approximately four months later). All children assigned to the waitlist-control condition     will be offered FCT services by the investigators' clinic at the end of the four-month     waitlist period. These children will again be tested following four months of FCT (i.e.,     posttest). Therefore, children assigned to the FCT condition will be tested twice (one     pretest and one posttest), and children assigned to the waitlist-control condition will be     tested thrice (one pretest, a second pretest following a four-month waitlist period, and one     posttest).   "
61272|NCT02483559|"     The purpose of the study is to test the use of amber glasses at night as a method to block     blue light from the eye, allowing the brain to produce a dim-light melatonin onset. The     investigators hypothesize that blue-blocking will produce measurable benefits in subjectively     and objectively rated sleep quality and mood as well as salivary melatonin levels during the     night.   "
61273|NCT02483546|"     High fidelity Simulation has spread from anesthesiology to other disciplines such as internal     medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in     medical education has increased exponentially. The term ''simulation'' spans a wide variety     of formats, from the low-tech actor portraying a standardized patient to high-fidelity     mannequin-based human patient simulation (HPS). HPS is able of both simulating realistic     patient encounters and giving real-time, physiologically accurate feedback. Studies thus far     show that use of simulation in training medical students and residents is helpful in     strengthening students' knowledge and in evaluating their performance. Students appreciate     simulation-based education as ''an opportunity to learn new skills in a safe environment .   "
61274|NCT02483533|"     LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of     clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 or     LIPO-202-CL-19 (parent studies). No risks related to treatment are anticipated as subjects     will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on     study.   "
61275|NCT02483520|"     This clinical trial will test the FamTechCare intervention that uses multidisciplinary     professional guidance based on in-home video monitoring to support family caregivers in     managing challenging behaviors of persons with dementia (PWD). Families provide the majority     of care for PWD at home. However the stress of caregiving is so significant that it increases     caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in PWD that     frequently lead to nursing home placement. In-home video monitoring allows experts to assess     behaviors of PWD and to identify antecedents, recommend specific interventions. FamTechCare     uses new technology to link family caregivers to experts for guidance in managing disruptive     behaviors, supporting continued care at home while reducing the negative effects of     caregiving.      Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both     groups will record behaviors during daily care for 3 months using a home monitoring unit.     Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording     behavior triggers and precursors. Caregivers record care situations they select and upload     videos to a secure site. The expert team will review intervention group videos weekly and     will provide individualized feedback for improving care to caregivers in the home. The     control group caregivers will receive a weekly phone call and advice from a nurse, but their     recorded videos will be held for review and individualized feedback provided after 3 months.      Study aims are to use observation to assist caregivers in behavior management. Effects on     disruptive behaviors and caregiver burden and other negative outcomes will be compared.     Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors     influencing likelihood of translation into practice. This is the first study to test new     technology for direct observation and immediate feedback to empower families to manage PWD     behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers     to individualized expert guidance, acknowledging the importance and burden of their role.     This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease     goals, integrating strategies to promote adoption and use of aging services technologies in     interventions that will reduce negative caregiver outcomes, a growing public health problem.   "
61276|NCT02483507|"     Landmarks used to make a vascular puncture has long been based on the only knowledge of     anatomy. This method assumes that the target vessel is in its expected position, permeable     (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions     is likely to cause failures of puncture and complications. The development of ultrasound     allowed to see the structures to achieve, whether before a puncture or in live for guiding     the procedure. Visualization of vessels and adjacent structures has logically resulted in     larger cases to a greater security of catheterization, improving the success rate, and     decreasing complications. Several positions of the probe can be used to guide a puncture     under ultrasound: the transversal approach in short axis, the long axis longitudinal approach     and the oblique view approach.The aim of the study was to compare these three different     ultrasound-guided approaches to peripheral vascular access in children. All children weighing     less than 30 kg that should benefit from the introduction of an arterial catheter or central     venous catheter introduced through a peripheral vein are eligible. Patients will be included     after parent's and children's information and consent. The choice of the technique used     (transverse, longitudinal or oblique approach) is determined by a randomization table.The     puncture procedure is performed according to the usual protocols of the paediatric anesthesia     unit of the investigators, under ultrasound guidance in a sterile manner. No time limit is     required for the identification and implementation of the catheter. The position of the probe     is dictated by the result of randomization and the Seldinger technique is used for the     establishment of the catheter. Beyond two unsuccessful attempts, the procedure is considered     as a failure. The anesthetist then uses the alternative technique of his choice. All     anesthetists participating in this study exercised their main activity in the Montpellier     University Hospital pediatric anesthesia unit. The laying of ultrasound-guided peripherally     inserted central catheter and arterial catheter is part of the current activity of the unit.   "
61277|NCT02483494|"     Aim. To develop and examine the effectiveness of an APN-led telehealth rehabilitative     programme as a transitional nursing therapeutic on readmission rates and health related     outcomes amongst patients with Acute Myocardial Infarction (AMI) post discharge.      Design. Randomized controlled trial with repeated measures.      Methodology. A consecutive sampling of 172 patients with AMI will be recruited from a     tertiary hospital in Singapore. Participants will be randomised into two groups. The     experimental group (ALTRA) will receive APN-led telehealth rehabilitative programme upon     discharge in addition to standard care. The control group will receive only standard     follow-up care.   "
61292|NCT02483299|"     The purpose of this study was to determine whether combined treatment with liraglutide and     metformin is more effective than metformin as monotherapy in the treatment of obese women     with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in     patients on combined treatment than in those on monotherapy.   "
62889|NCT02462473|"     The purpose of this study is to determine the number of Medication Treatment Modifications     (MTMs) made by the clinician at every visit when antipsychotic medication plasma levels     (AMPL) results are available compared to when AMPL results are not available.   "
61278|NCT02483481|"     Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive     disease-affecting children following bone marrow transplantation (BMT). SOS most likely     develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease     can be separated into mild, moderate, and severe forms; almost all patients diagnosed with     severe SOS will die from this disease. Children with severe SOS suffer from multi-organ     failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and     respiratory failure . Although these children may be few and far between, the mere severity     of the disease process and awful prognosis factors are valid reasons for more medical     attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis     and treatment, children continue to die from this devastating disease.      Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an     emerging technology that uses ultrasound pressure waves to provide an estimate of tissue     stiffness. This technique is promising for pediatric imaging because it is portable, quick to     perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation     imaging and ultrasound elastography does not have any increased risks over conventional     ultrasound imaging.   "
61279|NCT02483468|"     The primary objective of this study is to evaluate the effects of cognitive-behavioral     therapy in combination with transcranial direct current stimulation in (1) improving pain and     functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in     associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators     will also determine the effects of treatment on neural activity in cognitive and limbic brain     regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and     examine its relationship to opioid use severity.   "
61280|NCT02483455|"     This is a single-center, randomized, double blind, vehicle-controlled phase 2 study of     subjects 8 years of age and older with Common Warts (Verruca vulgaris) who desire treatment.   "
61281|NCT02483442|"     Prospective, multicentre, cohort study assessing a diagnostic management strategy for     suspected Pulmonary Embolism with independent central adjudication of outcomes   "
61282|NCT02483429|"     AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to     standard care to assess accuracy of diagnoses and initial management decisions for emergency     department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of     vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will     accurately, safely, and efficiently differentiate peripheral from central vestibular     disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the     potential to improve post-treatment clinical outcomes for these patients.   "
61283|NCT02483416|"     The study will take place over a period of 27 months. The recruitment phase will last     approximately 24 months and each patient will participate for approximately 3 months.      At the inclusion visit (D0), the investigator will ask the patient whether he would like to     participate in the study and will obtain his written consent.      Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the     following 2 groups:      Group without `remote additional personalised nurse-led follow-up: patients will receive the     healthcare given routinely by their medical team (100 patients).      Group with `remote additional personalised nurse-led follow-up: patients will receive     telephone calls from a nurse in addition to the healthcare given routinely by their medical     team (300 patients).      All the patients will be seen according to normal practice by the study medical team.      Patients in the group with `remote additional personalised nurse-led follow-up will be     contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse     will make sure that the treatment takes place in good conditions; she cannot intervene in the     medical care of the patient, nor give answer to the questions relative to the disease or to     the treatment of the patient. The medical team remains the privileged contact of the patient.   "
61284|NCT02483403|"     Healthy elderly subjects male and female aged 65-85 will undergo MRI, lung function and     exercise testing for the development of tools to quantify and validate longitudinal in vivo     magnetic resonance imaging phenotypes of the aging lung.   "
61285|NCT02483390|"     The increasing awareness of the importance of palliative care has led, in Israel, to the 2005     Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility to     palliative care remain unresolved. The use of e-health services is likely to expand the     ability of the medical, psychosocial and nursing staff to reach patients who are either     living in the periphery, are unable to make clinic visits or whose family members are     housebound in order to be caregivers. This exploratory research is designed to explore the     issues, barriers and advantages of e-health care through the perspective of the palliative     care staff members, the patients themselves and their caregiving family members.   "
61358|NCT02482441|"     This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability,     and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with     metastatic colorectal cancer.   "
63720|NCT02451579|"     A double-blind, placebo controlled study conducted at a single study site. Evaluating the     role of systemic antihistamine therapy in the reduction of adverse effects associated with     topical 5-aminolevulinic acid photodynamic therapy.   "
61286|NCT02483377|"     This research trial studies how well patient navigation and tailored treatment planning work     in Latina patients with breast cancer. Patient navigation and tailored treatment planning may     provide extra support by guiding patients through the healthcare system, remove barriers to     care and provide ease of access to essential resources, encourage patient participation in     their care, provide in-language summaries and plans for follow-up care, improve patient     access to needed supportive care services and may improve general healthcare experience in     Latina patients with breast cancer.   "
61287|NCT02483364|"     The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 in the     surgical treatment of atrophic nonunion in long bones.   "
61288|NCT02483351|"     The purpose of this study is to determine the feasibility of conducting a large trial     examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion     strategy compared to a restrictive strategy (usual care) in patients with aneurysmal     subarachnoid hemorrhage (SAH).   "
61289|NCT02483338|"     This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to     assess postoperative children pain.   "
61290|NCT02483325|"     Determine the efficiency of a myéloablative conditioning associating Fludarabine,     Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics     realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in     preparation for a allogenic transplant family or not family compatible HLA.   "
84243|NCT02183597|"     Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate     diagnostic accuracy through application of optimized protocols for screening of cancer     patients.   "
61293|NCT02483286|"     OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among     community-dwelling older adults with high osteoporotic fracture risks.      MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall,     osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National Taiwan     University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group (ICG,     target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang Gung     Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All     participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty, fall     prevention, nutrition, and coping strategy and another hour of professional led exercise     program. ICG subjects received once weekly group exercise while MTG subjects received twice     weekly machine-based resistence training on major muscle groups. XBG subjects rececived twice     weekly exercise with X-box based programs. Major outcomes were muscle mass (measured by     bio-impedance analysis), grip strength, walking speed, and lower leg extension power at     baseline and after 12-weeks of intervention.   "
61294|NCT02483273|"     Study hypothesize that ocular microcirculation is reflecting cerebral perfusion. The purpose     of this study is to evaluate ocular microcirculation in brain dead patients using side dark     field (SDF) videomicroscope and compare it with microcirculatory parameters of healthy     volunteers.   "
61295|NCT02483260|"     To provide an intravenous ribavirin therapeutic option for patients with a probable or     suspected case of viral hemorrhagic fever, specifically Crimean-Congo hemorrhagic fever or     Lassa fever.   "
61296|NCT02483247|"     This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination     with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of     the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with     each of the selected anti-cancer agents.   "
61297|NCT02483234|"     Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions     in psoriasis patients and patients with PsA. Primary Objective is the improvement of the     PsAMRIS synovitis score baseline vs. week 24.      Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. with a     duration total of 24 weeks. Indication for this study is Psoriasis (Pso) and psoriatic     arthritis (PsA).   "
61298|NCT02483221|"     Treatment of postoperative pain with hydromorphone (a strong analgesic) using     patient-controlled analgesia with target-controlled infusion compared to conventional     patient-controlled analgesia with morphine after elective cardiac surgery   "
61299|NCT02483208|"     The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after     intravenous administration.   "
61300|NCT02483195|"     The investigators propose to conduct a head-to-head, randomized clinical trial to compare the     effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal     females with Androgenetic Alopecia (AGA).   "
61301|NCT02483182|"     This is a phase II, prospective, randomized, double-blind, parallel group,     acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary     therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes     labialis), following five consecutive treatment days with five times daily topical     administration.   "
61302|NCT02483169|"     Through this study, the investigators are to prove that Cilostazol effectively prevent     progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral     hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side     effects.      The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the     progression of intima-medial thickness compared to aspirin in the ischemic stroke patients     with symptomatic or asymptomatic old cerebral hemorrhage.   "
61303|NCT02483156|"     Two Groups of Genotype 4 HCV Patients will participate through open-label randomized Study     comparing Sofosbuvir tablet Plus Ribavirin tablet (Part A) versus single Dose (2 tablets) of     EHCV containing Sofosbuvir, Ribavirin, and Natural anti-hemolytic (B) evaluating the safety     and efficacy for both arms.      Sponsor: Wadi El Nil Hospital      Study Centers Planned: Approximately 2 sites in Egypt   "
61359|NCT02482428|"     The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety,     tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an     additional open label arm using imiquimod 5%.      During the study the patients received either LFX453, placebo or active comparator and the     tolerability and safety was assessed continuously through local tolerability assessments and     adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study     biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken     for safety, pharmacokinetics (PK), and biomarkers.   "
61304|NCT02483143|"     Study objective:      The purpose of this study was to compare the role of the prophylactic protocols     N-acetylcysteine (NAC) plus normal saline, sodium bicarbonate (NaHCO3) plus normal saline and     intravenous normal saline (NS) alone in the prevention of contrast-induced nephropathy (CIN)     after computed tomography pulmonary angiography (CTPA) in emergency patients with suspected     pulmonary embolism (PE).      Materials and methods:      This study was planned as randomized, double blind, placebo controlled clinical research.     Patients presenting to the emergency department within a 1-year period, undergoing CTPA on     suspicion of PE and having one or more risk factors for development of CIN were included in     the study. The NAC group received 1 ml/3 mgr NAC+NS solution 1 h before CTPA and 1 ml/kg per     hour for a minimum 6 h after CTPA. The NaHCO3 group received 132 mEq NaHCO3+NS solution for 1     h before CTPA and 1 ml/kg per hour for a minimum of 6h after CTPA. The normal saline (NS)     group received 3 ml/kg NS for 1 h before CTPA and 1 ml/kg per hour NS for a minimum 6 h after     CTPA. CIN was evaluated as the primary outcome, and moderate renal injury (defined as a 100%     increase in serum creatinine levels), severe renal insufficiency requiring hemodialysis or     peritoneal dialysis) or in-hospital mortality as secondary outcomes.   "
61305|NCT02483130|"     A double-blind, placebo controlled, crossover study to determine whether a single dose of     N-acetylcysteine (a nutritional supplement) can reduce brain glutamate levels in patients     with a psychotic disorder. Secondary outcomes are to determine the pattern of alteration in     brain perfusion and activity following a single dose of N-acetylcysteine.   "
61306|NCT02483117|"     The Clinical Impairment Assessment (CIA) assesses psychosocial impairment secondary to an     eating disorder. The aim of this study was to create and validate a Spanish-language version     of the CIA. Using a forward-backward translation methodology, we translated the CIA into     Spanish and evaluated its psychometric characteristics in a clinical sample of 178 ED     patients. Cronbach's alpha values, confirmatory factor analysis (CFA), and correlations     between the CIA and the Eating Attitudes Test-12 and the Health-Related Quality of Life in     ED-short form questionnaires evaluated the reliability, construct validity, and convergent     validity, respectively. Known-groups validity was also studied comparing the CIA according to     different groups; responsiveness was assessed by means of effect sizes.   "
61308|NCT02483091|"     To assess the feasibility of conducting a larger cluster randomized controlled trial to     facilitate the effectiveness of a complex Knowledge Translation (KT) intervention, i.e.     implementation of multimodal care, into chiropractic clinical practice, designed to improve     the management of patients with Non-Specific Neck Pain (NSNP) disorders.      To evaluate feasibility, the investigators will ascertain how well participating     chiropractors and patients adhere to the study protocol and will solicit feedback from them     about the overall usefulness of the content and format of the KT intervention. This study     will determine planning for the main study and also the outcomes to be used as a primary     outcome.   "
61310|NCT02483065|"     People with dementia have complex medical, social, and psychological needs and can be     exacerbated by physical illness and the complex relationships between health care systems,     patients and their families or caregivers. They are a vulnerable and fragile population that     differs significantly from the population without dementia. Therefore, the investigators     propose the following objectives: 1. To describe the evolution of dementia patients admitted     during the study period in two hospitals in the Basque Health Service-Osakidetza and     complications associated with such admissions. 2. To compare with a control group (matched by     type of pathology, age and sex and adjusting for other clinical variables (severity of     dementia ...) the patient's condition before and after admission, in terms of quality of     life, dependency, instrumental activities of daily living and severity of dementia. 3. To     compare the length of stay, complications, mortality rate, the degree of dependency and     quality of life of patients with dementia compared to those without dementia, matched by     groups of pathologies, gender and age.   "
61311|NCT02483052|"     RejuvenAir System treatment will be performed during preoperative bronchoscopy 2 to 90 days     prior to prescheduled lung resection in Subjects requiring lobectomy for removal of     peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that     will be removed, distal to the anticipated margin of resection. Treatment should be at least     1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will     be inspected via bronchoscopy at the time of thoracotomy, and examined histologically     following surgical resection. Subject participation will be from 1 to 90 days and enrollment     is anticipated to take 3 months. Subject having a RejuvenAir procedure and not going on to a     resection for any reason will be followed for a maximum of 90 days for safety and undergo     bronchoscopic evaluation of the treated airways at 90 days (+/- 4 Days)) post treatment.   "
61312|NCT02483039|"     The primary objective is to evaluate the impact of an AKI Follow-up Clinic on major adverse     kidney events (MAKE) in comparison to hospitalized patients surviving an episode of AKI who     are not exposed to the AKI Follow-up Clinic intervention.   "
61313|NCT02483026|"     This study will examine the effect of providing a structured program of daily nutritional     supplements for a 6 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on     bone mass density status and formation of critical nutritional deficiencies years after the     surgery.   "
61314|NCT02483013|"     Objective:The aim of this clinical study was to evaluate tooth color alteration (ΔE) and     tooth sensitivity (TS) in patients that used two commercial brand-whitening dentifrices for     four weeks. Sixty participants were selected in accordance with inclusion and exclusion     criteria and randomly allocated in three groups (n=20): G1-Colgate Luminous White®, G2- Close     up White Now® and G3- Sorriso® dentifrice (placebo). Then, participants received the     instructions to use only the blinded supplied dentifrice and toothbrush to make the habitual     oral hygiene, three times per day during four weeks. Evaluators assessed tooth color     (CIEL*a*b system) and TS (VAS scale) at baseline and every week (assessment points 1, 2, 3     and 4). Two-way ANOVA and posterior Tukey and Friedman test analyzed data (α = 0.05).   "
61369|NCT02482298|"     The purpose of this study is to determine whether ticagrelor is effective in reducing the     number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle     cell disease   "
61370|NCT02482285|"     This study is looking at the feasibility of performing frailty assessments on elderly     patients with advanced cancers   "
61315|NCT02483000|"     This phase I/II trial studies the side effects and best dose of anti-cluster of     differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given     before chemotherapy and stem cell transplant in treating patients with B-cell malignancies     that have not responded to treatment or have come back after responding to treatment. CD20 is     a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches     radioactive material to a drug that is designed to target CD20, which brings radioactive     material to the cancer cells to kill the cells. This may kill more tumor cells while causing     fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell     transplant may be more effective in treating patients with B-cell malignancies.   "
61316|NCT02482987|"     The purpose of this study is to compare two barrier membrane products, Cytoplast (dPTFE) and     BioXclude (human amnion chorion allograft), for their relative efficacies in dental socket     preservation procedures, both when the socket is filled and overfilled with freeze dried bone     allograft (FDBA).   "
61317|NCT02482974|"     This study aims to determine the safety and efficacy of conversion of sirolimus to everolimus     in the maintenance treatment of LT recipients. Patients will be monitored every 12 weeks     after the switch of treatment for 48 weeks. The laboratory tests including hematological,     renal, hepatic, and metabolic parameters will be performed at each visit. Twenty-four-hour     urine creatinine clearance and proteinuria will be determined from a 24-hour urine collection     at baseline and week 48.   "
61318|NCT02482961|"     This study purposed to examine the adequate range of therapeutic concentration for Korean     people by observing curative effects, side effects, blood concentration, etc. in treating     CRAB-infected patients with colistin.   "
61319|NCT02482948|"     The purpose of this study is to compare how well two products, Active Leptospermum Honey     (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living)     tissue.   "
85410|NCT02168101|"     The purpose of the study is to determine whether MLN9708 is effective as maintenance therapy     following allogeneic stem cell transplant in patients with high-risk multiple myeloma.   "
61321|NCT02482922|"     Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise     training (IET) and nutrition program, as well as its preliminary effects on resting heart     rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among     primary care patients who have at least one risk factor for cardiovascular disease (CVD).      Participants : 30 patients who receive care from the University of North Carolina (UNC)     Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC     patients, not diagnosed with severe illness), will be enrolled to test the feasibility of the     home-based interval exercise and nutrition program.      Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In     Phase I, 15 patients will be enrolled into the program, which will take approximately 3     months. At baseline, data will be collected on age, height, weight, resting heart rate, blood     pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin, percent body     fat, cardiovascular fitness, and use a series of questionnaires to evaluate mood, sleep,     hunger, and quality of life. At closeout, the investigators will measure patients' adherence     to each component of the intervention. In Phase II, an additional 15 new patients will be     enrolled in either the identical protocol, or a slightly modified intervention (if necessary     based upon our results from Phase I). All patients will have the same variables measured at     baseline during their study visit at 3, 6 and 12 months after enrollment into the study.   "
61322|NCT02482909|"     The purpose of this prospective randomized study is to compare the efficacy and safety of     radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very     homogeneous underlying conditions.   "
61323|NCT02482896|"     The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in     Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent     than in the urban areas of the country. The population study aims at examining complexities     of environmental, hereditary, lifestyle, and social factors as determinants and predisposing     factors for morbidity, health, and quality of life. The study will cover physical, mental,     and social dimensions and examine family patterns and subgroups. The study will provide     baseline information for later follow-up.   "
61324|NCT02482883|"     Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all     cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological     sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly     related to the initial damage induced by SAH and delayed cerebral ischaemia (DCI), which is     generally secondary to cerebral vasospasm.      Cerebral vasospasm is one of the main factors of poor prognosis after SAH, as it is     associated with a 1.5- to 3-fold increase in the mortality rate during the 2 weeks following     SAH in these patients.      Despite a significant improvement in the time to management of this disease and the fact that     the ruptured aneurysm is very often rapidly excluded by surgical or endovascular     intervention, patients who survive the initial SAH remain at risk of severe complications     over the following 2 weeks.      Vascular stenosis of an arterial segment, called cerebral vasospasm, is observed in more than     70 to 95% of cases on digital subtraction angiography between the 7th and 14th days after     ruptured aneurysm. This angiographic vasospasm can be responsible for cerebral infarction in     52 to 81% of cases.      Despite 50 years of research, no clearly demonstrated effective treatment for vasospasm is     currently available.      This is a multicentre, randomized, comparative study, including 364 patients during the acute     phase following ruptured aneurysm, in whom management is very often limited to control of     complications, after exclusion of the aneurysm.      The objective of this study is to validate the efficacy of transcutaneous trigeminal nerve     stimulation for the prevention of vasospasm and limitation of the consequences of delayed     cerebral ischaemia after SAH.      This is an innovative project, as it comprises intervention in these patients prior to the     development of complications and could limit the development of these complications. The     prevention tool, based on external facial nerve stimulation, is a totally innovative,     reversible and noninvasive technique. Use of nerve stimulation in this indication has never     been previously reported and could radically modify the intensive care management of this     disease over the years to come.   "
61325|NCT02482870|"     The investigators studied the correlation between the Mallampati classification and the     Cormack-Lehane grades obtained with Macintosh and the King Vision video laryngoscopy in adult     patients scheduled for general anesthesia.   "
61371|NCT02482272|"     The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus     Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with     LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or     Adefovir   "
61372|NCT02482259|"     This study is looking at the feasibility of performing frailty assessments on patients with     advanced hepatocellular cancer.   "
61373|NCT02482246|"     Healthy parturients presenting for scheduled cesarean delivery will have blood drawn and     measured for microparticles at baseline, immediately after delivery, and at several time     points thereafter.   "
61326|NCT02482857|"     This is a single-center, open-label, randomized controlled trial. Patients with stable angina     pectoris without use of dual antiplatelet therapy or anticoagulation therapy scheduled for     coronary artery bypass grafting (CABG) at Karolinska University Hospital in Stockholm, Sweden     will be eligible.      This study investigates in patients having undergone CABG whether increasing the dose or the     frequency of acetylsalicylic acid (ASA) treatment improves the efficacy of ASA regarding     platelet inhibition compared to the standard dosing for cardiovascular prevention (75 mg once     daily) in the first three months after surgery. Patients will be randomly assigned to     postoperative ASA dose 75mg once daily, 75mg twice daily or 160 mg once daily. The study dose     ASA will be started at hospital discharge and continued of three months. Blood samples for     serum thromboxane B2 (TxB2) and other analyses will be taken before surgery, before     discharge, and after one and three months. All available data will be collected     prospectively. Informed consent will be obtained from patients meeting the inclusion criteria     before the initiation of any study-specific procedures.   "
61327|NCT02482844|"     The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy which     is booming in the management of aortic stenosis. It concerns patients who have a high     surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular     replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less     invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch     Block (LBBB) is one of the most frequent complications of this procedure and represents an     important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent     pacing in 5 in 15 % of the cases in 1 year.      De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation.     However, there are no predictive elements of these conductive disorders. Besides, the     incidence and the deadline of appearance of this AV disorders are not established. It seems     relevant to propose a new stratification based on ECG and endocavitary data. The monitoring     of the conductive disorders is allowed by remote monitoring thanks to the implantation of a     pacemaker or an implantable holter allowing to determine the incidence and the deadline of     appearance of high grade AV conduction disorders.   "
61328|NCT02482831|"     This study aims to compare the sensory and motor block duration and the incidence of nerve     injury after sciatic nerve block between diabetic and non-diabetic patients, and screen for     the factors that may affect the block recovery.   "
61329|NCT02482818|"     The purpose of this study is to determine if Pregabalin, a medication used for the treatment     of seizures and chronic pain, can be used to effectively treat people who suffer from     non-asthmatic chronic cough (cough lasting over 8 weeks).   "
85411|NCT02168088|"     This study seeks to incorporate genetic testing into the postmortem examination of cases of     sudden unexplained death.   "
61332|NCT02482779|"     Health-related applications for smartphones represent a new and popular market for consumer     oriented products. These applications are generally not considered medical devices and, as     such, are not under the purview of the Federal Drug Administration. Some of these     applications purport to measure vital signs, but do not have any published data to confirm     accuracy of such measurements and their developers have not been willing to divulge the     methods by which vital sign readings are produced.      Use of unvalidated application derived data may contribute to patient harm as patients may     make healthcare decisions based on the results these applications provide. This study aims to     assess the accuracy of several such applications by comparing their findings to those of     clinical vital sign monitors commonly used in the perioperative setting.   "
61333|NCT02482766|"     The primary hypothesis of this study is reduction in need of mechanical ventilation in the     first 72 hours of life (excluding the transient tracheal intubation performed for surfactant     administration and the mechanical ventilation for lung recruitment) in spontaneously     breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24     hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no     recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt     extubation.   "
61334|NCT02482753|"     This study was to evaluate the efficacy and safety of Chidamide in combination with     exemestane in postmenopausal patients with hormone-receptor positive advanced breast cancer.   "
61335|NCT02482740|"     The investigators design a phase 2, open labeled, randomized trial of Tamoxifen (20 mg/day)     and Letrozole (2.5 mg) in treatment of squamous carcinoma of the cervix. Forty four patients     with recurrent or persistent disease will be recruited, randomized, treated and followed     three-monthly for 12 months. The primary end point is the treatment response rates. Secondary     end points include survivals, ECOG performance status, quality of life and efficacy of     biomarkers in predicting the responses. Candidate biomarkers including ER, PR, GPER and HPV     genotype in paraffin cancer tissues as well as methylated genes in the blood will be studied     in relation to the therapeutic outcomes.   "
61336|NCT02482727|"     Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads     to beneficial changes in muscle strength at low resistance and minimal stress on the nearby     joint. This novel resistance training has the potential to greatly improve muscle strength     gains in individuals who are unable, for medical reasons, to perform the high resistance     exercises typically required to improve strength. Our study will examine the effect of this     technique on strength recovery following distal radius fracture repair. The primary objective     of the intervention is to achieve accelerated recovery of forearm, wrist and hand function as     assessed using measures such as grip/pinch strength, validated questionnaires, and functional     outcome testing. Occlusion training can potentially serve as a specialty intervention for     rehabilitation patients, reduce the cost of care, and improve the treatment options for both     patients and providers.   "
61337|NCT02482714|"     The primary purpose is the evaluation of life quality of Fibromyalgia patients. The     investigators' main hypothesis includes the role of geographical, sociological, psychological     and physical activity on life quality.   "
61338|NCT02482701|"     To confirm performance of the Captivator™ EMR device for resection of early neoplasia in     Barrett's Esophagus.   "
61388|NCT02482051|"     The purpose of this study is to develop a new and very rapid diagnostic test for identifying     a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of     bacteria will assist in decreasing the use of antibiotics and help more patients survive     bacterial infections of the blood.   "
61339|NCT02482688|"     Stroke is the number one cause of disability in the United Nations with about 1 million new     cases each year. Following stroke, patients with perceptual and cognitive impairments have     the worst prognostic outcomes. There is evidence to suggest that perceptual and cognitive     symptoms can be alleviated by multisensory integration, which has the effect of enhancing     motor, perceptual and cognitive processes. This research project will investigate for the     first time the functional benefits that stem from multisensory stimulation of attention in     stroke patients with perceptual and cognitive impairments. The research project will involve     multisensory learning paradigms with stimulus and environmental parameters that optimally     enhance perceptual learning and cognitive function. Multisensory learning paradigms will be     tailored for patients with stroke to determine the perceptual and cognitive symptoms that can     be alleviated, and fMRI will be used to evaluate the underlying neural substrates of the     effects. The project will show whether multisensoty stimulation provides an effective means     of attentional rehabilitation after stroke and whether the effects generalize to everyday     life, with long-term outcomes that improve functional independence in patients with stroke.   "
61340|NCT02482675|"     Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term     increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function     and increase the risk of CVD. Greater intakes of dairy foods have been associated with a     lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods     in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart     health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated     responses leading to vascular dysfunction. This provides rationale to further investigate     dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to     define the extent to which dairy milk, and its whey and casein protein fractions, protect     against postprandial vascular dysfunction by reducing oxidative stress responses that limit     nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.   "
61341|NCT02482662|"     Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral     glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting     since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by     pregnant women. As many OGTT are false positive according to self-monitoring blood glucose     (SMBG), the investigators need now to determine the percentage of OGTT results that are false     negative.      The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of     OGTT will determine the exact percentage of false negative OGTT results.      The opinion of women will also be taken into account. In the everyday clinic, many report     that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable     drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been     performed, the investigators will investigate formally what women think using a     questionnaire.   "
67418|NCT02403284|"     In this research study, investigators will test the effects of an approved medication for     diabetes,Liraglutide, to reduce insulin resistance that develops from eating a diet high in     saturated fats.   "
61342|NCT02482649|"     The aim of this study is 1) to investigate clinical effects of equine-assisted activities and     therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to     compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This     study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of     EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at     baseline and after EAA/T or drug therapy.   "
61343|NCT02482636|"     This multicentre, parallel group, block randomised clinical trial aims to investigate the     post booster antibody response in UK infants given a reduced priming schedule of     meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will     provide information about how best to include the meningococcal B vaccine (likely to be     introduced late 2015) into the routine immunisation schedule.      The UK Department of Health provides a routine vaccination schedule for children in the UK     and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The Department     of Health have announced that the meningococcal B vaccine (Bexsero) be introduced to the     routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by removing the     current MenC conjugate vaccine dose given at 3 months of age. There is no published     immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1 schedule) and     with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the infant programme.      This change to the schedule would result in three injections at 2, 4 and 12 months, and given     previous reluctance among parents for three injections at one visit, an option to reduce     PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be assessed     in this study.   "
61344|NCT02482623|"     Persons with dementia and their caregivers are often cared for in the community through home     healthcare (HHC). While these patients and their caregivers need significant help and often     have difficulty maintaining their quality of life, home healthcare clinicians are often     unprepared to care for this population. This study will therefore examine the ability of an     integrated, multi-pronged evidence-based practice intervention for home healthcare registered     nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of     care and quality of life for persons with dementia and their family caregiver. The     investigators will enroll persons with dementia and their family caregiver upon admission to     the HHC agency and examine their quality of life over 60 days following admission, comparing     those who receive the intervention to those who serve as controls.   "
61385|NCT02482090|"     Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive     clinical results with durable complete responses in patients with metastatic melanoma. The     TILs are isolated from patients own tumor tissue followed by in vitro expansion and     activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion     Interleukin-2 is administered to support T cell acitivation and proliferation in vivo.      Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,     including Ovarian Cancer. In this study TIL therapy is administered to patients with     metastatic Ovarian Cancer.   "
61386|NCT02482077|"     The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir     containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2     infection.   "
61345|NCT02482610|"     Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term     increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function     and increase the risk of CVD. Greater intakes of dairy foods have been associated with a     lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods     in the diet that might increase CVD risk is unclear. Further controversial is the extent to     which dietary fat derived from dairy foods regulate the risk of CVD. The health benefits of     dairy on CVD risk are at least partly attributed to its ability to limit PPH and resulting     PPH-mediated responses leading to vascular dysfunction. This provides rationale to     investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart     disease. The objective of this project is to define the extent to which full-fat dairy milk     compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing     oxidative stress responses that limit nitric oxide bioavailability to the vascular     endothelium in adults with prediabetes.   "
61346|NCT02482597|"     Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a     diverse and growing list of disorders including cardiovascular disease 6. During WBPA,     patients lie in the supine position on a bed that is capable of translating back and forth     parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is     best described as a form of passive exercise. The frequency of the translation (up to 180     cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by     the patient or health care professional.      The science behind the therapeutic effects of WBPA still remains largely unknown.      The objective of this study is to determine if WBPA may be used as an effective way to reduce     lactic acid concentrations during recovery after intense exercise more rapidly than     previously established methods.   "
61347|NCT02482584|"     The purpose of the trial is to investigate the effects of three months' treatment with a     CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D)     patients with newly detected Obstructive Sleep Apnoea (OSA).   "
61348|NCT02482571|"     The primary objective of this research is to measure neurochemicals in the activated human     brain during both normoxia (normal oxygen availability) and induced mild hypoxia (reduced     oxygen availability).   "
61349|NCT02482558|"     The aim of this study is to investigate the effect of a one week high versus low glycaemic     index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in a     two way cross overs study and to see if there is any correlation between this and satiety or     appetite.   "
61350|NCT02482545|"     Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high     fiber meal replacement in overweight individuals, on body composition.      Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of     disease. Procedures (methods): In a randomized control intervention, subjects will complete 5     different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing     sessions) as well as an 8 week intervention period. Pre-screening will include written     informed consent, health history questionnaire, nutrition analysis, and baseline     anthropometric measures. Baseline testing will be split into two sessions and include     measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones,     mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory     fitness assessment.      Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement     to be taken at breakfast) and control groups (continue normal eating habits) with 4     electronic correspondences throughout the supplementation period. All measures will be     repeated in two post-testing sessions.   "
61351|NCT02482532|"     The researchers will investigate if modified T-cells from a patients own system can be     utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.   "
67419|NCT02403271|"     This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in     combination with durvalumab (MEDI4736) in subjects with relapsed or refractory solid tumors.   "
61352|NCT02482519|"     Marrow adipocytes have been identified as a component of the bone marrow micro-environment.     Evidence exists suggesting that marrow fat plays an important physiologic role in both bone     mineral and energy metabolism in humans. The investigators will study the effects of acute     weight gain and acute nutritional deprivation on energy homeostasis and bone mineral     metabolism by examining marrow adiposity, peripheral fat depots and bone microarchitecture.      The study will include two ten day inpatient study visits. Participants will eat a high     calorie diet for 10 days, followed by a 13-18 day stabilization period at home, and then     return for a ten day fast.   "
61353|NCT02482506|"     This is a randomized intervention study to examine the effects of the Moving Forward Guided     Weigh Loss Intervention compared to a self-guided weight loss program on BMI and behavioral,     biological, and psychosocial outcomes in overweight and obese African American women     diagnosed with Stage I, II, or III breast cancer.   "
61354|NCT02482493|"     Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic procedures.     Approximately 84,000 knee replacement procedures were recorded in the UK in 2012. The main     goal of TKA is to relieve the disabling pain of arthritic disease.      Patient satisfaction following TKA is related to quick recovery and return to daily     activities. This can be dependent on the design of the implant used in the knee. Improvements     in implant design and surgical technique mean many modern designs offer implant survival     rates beyond 10 - 15 years.      As cost pressure increases in the NHS the unit cost of implants is now being scrutinised,     particularly with regard to cost effectiveness. The Press-Fit Condylar (PFC) Sigma implant     can be used with either a conventional metal backed or alternatively an all polyethylene     tibial component (part fitted to the shin bone), the latter considerably cheaper to     manufacture. Four small prospective randomised trials and one large regional registry study     with long follow up support the safe use of all polyethylene tibial components in TKA. The     investigators will therefore undertake a prospective randomised controlled trial comparing     the results of all polyethylene tibial components with those of conventional metal backed     tibial components in patients aged 75 or over, comparing both clinical outcome and     radiological survivorship.      The type of knee replacement used for each patient (metal-backed or polyethylene) will be     chosen at random once a patient has agreed to take part in the study.      Data will be collected by means of follow-up appointments and questionnaires and clinical     tests both before the operation 1 year, 2 years and 5 years postoperatively. This will allow     us to see how both types of knee replacement perform over time and if one performs better     than the other in terms of patients movement, pain and functional activities.   "
61355|NCT02482480|"     Study objetives : The aim of this study is to assess the impact of a combined therapy     treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on     symptoms and quality of life in patients with OSAS, as an alternative or addition to     therapeutic treatment with nocturnal CPAP.   "
61360|NCT02482415|"     Health care systems are increasingly using outpatient care for patients with advanced cancer     disease with complex needs, limited life expectancy, and need for palliative care. Family     caregivers are centrally important, but are often insufficiently prepared for the caregiving     role, and experience psychological distress and physical symptoms. We hypothesize that a     psycho-educational intervention during ongoing palliative care will support family     caregivers' wellbeing and decrease negative consequences of caregiving.      The intervention, which has been developed in steps through a series of studies based on     theoretical, methodological, and empirical work, was delivered in a group format 2013-2014.     Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each     meeting had a specific topic presented by a member of the palliative care team (physician,     nurse, and social worker). The meetings addressed multi-dimensional issues in dialogue with     the participants.      The overall aim of this ongoing project is to investigate short and long-term effects of the     intervention delivered by health professionals at ten specialized palliative home care units.     Multiple methods are now being used, including a randomized controlled trial (RCT). In total,     270 family caregivers have been requested to answer a questionnaire at four time points: at     baseline, upon completion and again 2 months after completion of the intervention, and 6     months after the patient's death. The primary outcome variable is preparedness for     caregiving, and the secondary outcome variables cover aspects of wellbeing including     competence and reward, caregiver burden, health, anxiety and depressive symptoms, and grief.     These data will be complemented with interviews.      The project has the potential to contribute knowledge about the development of support for     family caregivers, not only in specialized palliative care but also in other contexts such as     elderly care and general home care services.   "
61361|NCT02482402|"     Trial Rationale/ Justification To assess efficacy and safety of inhaled Iloprost in treatment     naïve patients with left heart failure and pulmonary hypertension, who are on the waiting     list for orthotopic heart transplantation. As patients often show increasing hemodynamic     values while waiting for a donor organ, the transplantation becomes infeasible at the time of     identification of an appropriate donor organ when reaching the exclusion limits. Therefore,     there is a high need of improvement and stabilisation of the patients' hemodynamic values as     PVR, PAP and TPG. In a retrospective, non-controlled study inhaled Iloprost has already shown     a beneficial effect on the hemodynamics as reduction of PVR, TPG and CI (Schulz 2010).     Treatment with inhaled Iloprost could stabilize the hemodynamics and prevent the patients     from being classified as ineligible by the time an appropriate donor organ is identified.      However, the adverse event profile regarding frequency, time-dependency has to be further     validated to show safety and tolerability of inhaled Iloprost in this indication.      All patients can be transferred to a long-term medically supervised observation period with     inhaled Iloprost therapy.   "
61362|NCT02482389|"     This protocol seeks to utilize a novel method of tumor bed boost delivery and to better     understand breast cancer radiation response through the analysis of pre-and post-radiation     breast tumor samples.   "
61363|NCT02482376|"     This protocol seeks to build on the favorable results of the investigators' phase I trial     (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the     investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered     preoperatively to a larger group of subjects (n100).      The primary objective is to determine physician reported rates of good/excellent cosmesis at     baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale   "
61364|NCT02482363|"     Season of birth influences pregnancy for reasons that remain unclear however the answer may     lie in the amount of sunshine pregnant women are exposed to. Sunshine, or ultraviolet light     (UV) exposure is already known to have benefits for health on heart disease, strokes and     depression. In pregnancy, relationships between sunshine exposure are evident in birth     weight, preterm birth and risk of blood pressure complications. Vitamin D, the UV generated     hormone, was thought to be responsible when low vitamin D levels were associated with these     pregnancy complications. However, vitamin D replacement is ineffective at preventing these     outcomes, and the investigators hypothesise that this is because it is the UV that is     beneficial for pregnancy and it is working through a different pathway.      A new understanding of skin function is central to this, with a 2014 study showing that     exposing an adult to 20 minutes of low dose UV light lowered their blood pressure and     improved blood flow. These investigators demonstrated this was a direct effect of UV on the     skin and was mediated by nitric oxide, a chemical central to many aspects of pregnancy     including blood pressure regulation and uterine activity.      The investigators in this study have funding from Tommy's to investigate if a similar effect     is seen in pregnancy on the circulation. The design is similar to the previously successful     method and volunteers would be recruited from clinical areas during the second trimester. As     both resting and warming for 20 minutes have the potential to have similar effects on the     circulation, a control arm will expose participants to these without the UV.      This pilot study would involve one visit and measurements taken would include heart rate,     blood pressure, arteriography, ultrasound of the uterine arteries and blood measurements of     nitric oxide levels. Arteriography is performed using a specialised arm cuff and is safe and     non-invasive. A subset of these women would be invited to repeat this in the third trimester     to investigate for a difference in effect at a later gestation.   "
61365|NCT02482350|"     Hemianopia refers to compromised vision in one half of the visual field, in either one or     both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually     caused by stroke or head injury. In order to read, participants have to move their eyes along     a line of text three to four times per second. Such eye movements are called saccades. One     makes use of peripheral visual information to the right (if reading from left to right, e.g.,     in English) or to the left (if reading from right to left, e.g., in Arabic) of words. HA     patients are deprived of much of this information. Patients with HA require far more     saccades, which slows their reading significantly and often prevents them from reading     efficiently for work or pleasure. It follows that the reading ability of those who read     left-to-right would be compromised more by right-sided HA, and in those who read     right-to-left by a left-sided HA. This study proposes to explore the rehabilitation of     left-sided HA following stroke, in Arabic readers. An online treatment package has been     developed in English (http://www.readright.ucl.ac.uk/). Currently, no assessment or treatment     resources exist for the condition in right-to-left readers. The aim is to develop novel     Arabic reading tests and rehabilitation material. The current project proposes to 1)     translate this package into Arabic, 2) develop new Arabic reading test materials and 3)     collect data from Arabic reading stroke patients in a Phase 2 clinical trial. The hope is to     develop an effective, novel, and empirically supported reading treatment package for Arabic     readers with HA.   "
61366|NCT02482337|"     The purpose of this study is to show that the Per-Oral Endoscopic Myotomy (POEM) procedure is     an effective treatment for people with achalasia.   "
61367|NCT02482324|"     This is an open-labeled, cross-over design, pharmacokinetic study, to determine the     pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and     ALZT-OP1b, in both plasma and CSF, following co-administration of the active compounds, in     healthy volunteers, aged 55-75, and in good general health.   "
61368|NCT02482311|"     This is an open-label, multi-centre, Phase Ib study of AZD1775 designed to assess the safety,     tolerability, pharmacokinetics, and anti-tumour activity of AZD1775 monotherapy in patients     with advanced solid tumours.   "
61374|NCT02482233|"     The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes     and telephone counselling (compared to transdermal nicotine replacement and telephone     counselling) as a harm-reduction tool that may lead to increased smoking cessation in the     perioperative setting in smokers presenting for elective surgery at the San Francisco     Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes     over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit,     hospital length-of-stay, postoperative complications within the first 30-days, and smoking     status 8-weeks after randomization. This pilot study is designed to provide the preliminary     data necessary to plan and fund a larger-scale randomized clinical trial that will assess the     utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is     to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking     cessation, specifically in the perioperative setting where the risks of continued smoking are     great and the motivation to stop is high.   "
61375|NCT02482220|"     Acute exercise of high intensity has been shown to induced nutritional adaptations in obese     adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise     (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy     consumption at the following meal with no modification of their appetite feelings. Although     it is suggested that chronic physical activity programs can induce energy intake     modifications, this has never been clearly studied. The aim of this work is to compare     different physical activity programs (low vs. high intensity programs) in terms of energy     intake, appetite feelings and appetite-regulating hormones, in obese adolescents.   "
61399|NCT02481908|"     The aim of this investigation was to assess the value of Systolic Time Intervals (STIs) as a     method of detecting Left Ventricular Dysfunction (LVD) in patients admitted to the ED for     Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and whether STIs     measured under Valsalva manoeuver (VM) could improve the distinction between patients with     LVD and those without LVD.   "
61376|NCT02482207|"     Investigators recently demonstrated that coronary flow reserve (CFR) significantly improved     after rosuvastatin therapy in hypertensive patients with average levels of serum cholesterol     by measuring the change in CFR after 1 year treatment with rosuvastatin in the RESERVE     (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However, the     absence of a placebo group made it difficult to exclude the possibility that lifestyle     modification and antihypertensive medication also played a role in improving CFR in our     previous study. In a double-blind, randomized trial, investigators try to examine the     hypothesis that rosuvastatin added to lifestyle modification will be superior to lifestyle     modification alone in improving CFR in hypertensive patients .   "
61377|NCT02482194|"     The conventional treatment of spinal cord injury (SCI) includes physical therapy and     rehabilitation and in some cases may require surgical intervention. Although improved     emergency care and aggressive treatment can help in preventing further damage and even     restore minimal sensory functions, still a large proportion of patients suffer with prolonged     disabilities. It led neurologists to search out for new treatment options for this otherwise     debilitating disorder. Recent advances in research have developed a better understanding of     stem cell biology especially their role in tissue repair and regeneration. Encouraging     results in pre-clinical phase and limited human trials have proved that stem cells can be     safely and effectively delivered to the injured site for regeneration of damaged tissue.     Although a variety of cell types have been tried for their role in repair of spinal cord     injury, majority of clinical trials employed stem cells taken from bone marrow especially     mesenchymal stromal cells (MSC). Bone marrow MSCs are a good choice for regenerative     therapies owing to advantages like ease of collection and ex-vivo culturing, immune tolerance     and their ability to differentiate into a variety of cell types including neuronal lineage     cells. Intravenous application or direct injection of MSCs into cerebrospinal fluid (CSF) via     lumber puncture in animal models of SCI and brain trauma had shown that MSCs can migrate     towards and integrate into injured spinal tissue and reduce cyst size and increase functional     recovery. The literature indicates that acute, sub-acute and chronic injury can be a     therapeutic target for MSC grafting. The mechanism of action may however vary among these     conditions. In acute phase, MSC administration play anti-inflammatory role, while in     sub-acute/chronic setting it may be used as neurostimulator and for cell bridging effect and     possibly glial or neuronal cell replacement. The investigators propose a non-randomized,     single group, open label, phase-I, interventional study to evaluate the safety and efficacy     of intrathecal delivery of patient's own (autologous) bone marrow mesenchymal stem cells for     treatment of spinal cord injury. This will include determination of functional recovery     (neuro-muscular control and sensation) in the affected area and overall improvement in     quality of life of the patients and also take into account any side effects, if observed.   "
61378|NCT02482181|"     The purpose of this study, is to investigate the value of diffusion weighted imaging on the     differential diagnosis of solitary pulmonary lesions.   "
61379|NCT02482168|"     This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal     antibody APX005M in adults with solid tumors. Study is intended to establish the maximum     tolerated dose and the overall safety and tolerability of APX005M in 3 different     administration schedules.   "
61380|NCT02482155|"     The main purpose of this study was to evaluate the pharmacokinetic (PK) profile of ibuprofen     after oral administration of a single dose of MOMENT ACT ANALGESIC granules to healthy male     and female subjects, under fasting conditions.   "
61381|NCT02482142|"     The study aim at:      Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming     high carbohydrate meal.      Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming     high protein-low phosphorus meal.   "
61382|NCT02482129|"     The purpose of the study is to determine whether topical ocular administration of LME636 60     mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC)     associated with acute anterior uveitis (AAU).   "
61383|NCT02482116|"     This research investigates the diagnostic accuracy of various diagnostic approaches for     malaria and pneumonia in under-five children presenting to primary healthcare centres in     Benin City, Nigeria.   "
61384|NCT02482103|"     This study is a national registry of patients treated with renal denervation (RD) in the     Netherlands.      The aim of the study is to collect data on safety of the procedure, predictors of the blood     pressure lowering effect, sustainability of the effect and to assess the cardiovascular event     rate in patients treated with renal denervation.      This is a prospective observational study.   "
61387|NCT02482064|"     Ten patients who had had maxillectomy will be assigned to two groups employing two types of     'temporary obturators. The obturators in the first group will be made from heat cure acrylic     resin, whereas those in the second group from flexible resin.      A comparison will be made between the two materials in terms of oral-nasal seal using the     drinking water test as well as the mirror test.   "
61423|NCT02481596|"     This study evaluates a family-focused mobile phone-delivered intervention, called FAMS     (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes     in their self-management relative to a control group. The goal of this study is to ascertain     if family-focused content delivered to the patient can improve the patients' family support     for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.   "
61424|NCT02481583|"     The aim of this study was to characterise the pharmacokinetic properties and assess the     safety of different formulations of levosulpiride in healthy Chinese volunteers.   "
67420|NCT02403258|"     To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.   "
61390|NCT02482025|"     Medication discrepancies, defined as unintentional differences found between patients'     medical records and patients' reports of the medication they are taking, occur frequently     after hospital discharge, predisposing to adverse drug events (ADEs), emergency department     visits and readmissions. Resolving medication discrepancies - medication reconciliation - is     mandated at every care transition, but little is known about intervention strategies to     improve medication reconciliation in the post-discharge period, when patients may lack prompt     access to primary care and are at high risk for ADEs. To address this gap, the investigators     developed and pilot tested the Secure Messaging for Medication Reconciliation Tool (SMMRT),     with a pharmacist communicating with Veterans to review medications and reconcile     discrepancies after hospital discharge via Secure Messaging (SM), within My HealtheVet (MHV),     VA's patient portal. The objectives of The SMMRT Trial are therefore      To optimize the end-users' experience with SMMRT through usability testing and refinement of     the tool; To conduct a randomized controlled trial (RCT) of usual care vs. usual care plus     MHV Training vs. usual care plus MHV Training plus SMMRT to reduce hospital utilization; To     evaluate how Veterans and staff perceived the impact of SMMRT on routine clinical practices     and, specifically, on Veterans' interactions with their primary care providers.   "
61391|NCT02482012|"     Infants comprise a potentially vulnerable research population that received special     consideration and protections under the US Code of Federal Regulations - Subpart D. Of the     four categories of research involving children, 45 CFR 46.406 is of particular interest to     researchers, ethicists, parents, and clinical staff members since it concerns the conduct of     research with more than minimal risk without the prospect of direct benefit. Parents are     the surrogate decision makers for infants. When asked about this type of research in studies     pertaining to older infants and children, parent themes include: concerns of medical research     and research-related risk, desire to advance generalizable medical knowledge and knowledge     specific to their own child's disease. There are no data on parents' perceptions regarding     this category of research that target the premature, late-preterm and term newborn     populations.      This study involves a questionnaire for both staff (nurses and physicians) and parents. The     questionnaire represented 4 different infant scenarios in a random order. Respondents are     asked to answer questions related to enrollment in a research study for each of the 4     scenarios.   "
61392|NCT02481999|"     Evaluation of mechanisms and factors of anaesthesia on postoperative delirium and emergence     agitation as well as on postoperative cognitive function in children aged 0,5-8 years     scheduled for elective surgery. The depth of anesthesia in children for elective surgery aged     0,5-6 years is monitored with intraoperative Narcotrend-Compact-M-Monitoring.     Postoperatively the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) [Sikich et     al. 2004;Locatelli et al. 2013] is used to screen for the frequency of postoperative delirium     in the post anesthesia care unit discharge of the child after surgery. Cognitive testings are     performed in children of the study group (n= 470) and a control group (n= 80) with the     parents support to evaluate deficits in children in their cognitive areas (POCD     (Postoperative cognitive deficit)) at three different time points up to three months.   "
61393|NCT02481986|"     The Asthma Action at Erie Trial compares the current best practice in asthma self-management     education (certified asthma educator services) to an integrated community health worker (CHW)     home intervention in which the real-life challenges of patients and the health care system     are taken fully into account. This trial will provide clarity as to the expected effect size,     cost savings, and resources needed to integrate asthma CHWs into clinical practice.   "
61394|NCT02481973|"     Premenstrual syndrome (PMS) is related to the changes in the levels of hormones predominately     progesterone, oestrogen and prolactin, during the luteal phase of the menstrual cycle. Both     physical and psychological symptoms may occur from at least day 14 of the menstruation cycle     and cease by day 4 of menstruation. The symptoms may interfere with a female's daily     activities and have a negative impact well-being. There are a number of conventional     pharmacological drugs which are used in the treatment or alleviation of the symptoms of PMS,     however the drugs may have side effects and may negatively interact with other medications.     Research has shown that homoeopathy is beneficial in relieving or decreasing the severity of     PMS, however finding the individualised homoeopathic remedy can be difficult. Grant Bentley     developed a system that helps find the most suitable remedy for each individual case. The     Grant Bentley Method (GBM) uses homoeopathic case taking, photographs of the facial features     and repertorisation to determine the dominant miasmatic group of the patient. This aids in     the selection of specific homoeopathic remedy. There has been no research to show the effect     of the GBM on PMS.      This study aims to determine the effect of individualised homoeopathic treatment using the     GBM, on females with PMS by using case studies and a daily self-grading PMS chart.   "
61395|NCT02481960|"     A study to demonstrate safety, and feasibility for intraparenchymal injection of irinotecan     hydrochloride drug-eluting beads in the treatment of recurrent high grade glioma (HGG).   "
61396|NCT02481947|"     The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and     efficacy versus lubiprostone in constipated adults.   "
61397|NCT02481934|"     The purpose of this study is to determine wether activated and expanded autologous Natural     Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on     second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as     lenalidomide or bortezomib.   "
61485|NCT02480790|"     Objectives of the study are: To estimate the incidence of venous thromboembolism (VTE) in a     cohort of women with suspected ovarian cancer and evaluate changes in the coagulation system     in case of benign or malignant disease. The impact of changes in the coagulation system on     disease prognosis will be evaluated.   "
61398|NCT02481921|"     The primary goal of this proposal is to improve the quality of care and outcomes for patients     discharged with heart failure using an innovative multidisciplinary group intervention     approach. Heart failure is a complex chronic illness where comprehensive patient-centered     care is difficult and resource intensive. One potential solution is to use shared medical     appointments (SMA), where a multi-disciplinary team of providers with expertise in nutrition,     nursing, behavior and medication management join to manage heart failure. The investigators     will enroll patients from Providence, Cleveland and Phoenix VA Hospitals who were within 12     weeks of discharge from a heart failure hospitalization and randomized them to receive SMA     intervention or usual care. Results from this project are expected to add an innovative     intervention that could improve outcomes important for both the patient and the VA: health     status, hospitalizations, and mortality.   "
86000|NCT02160340|"     The purpose of this study is to evaluate the prevalence of vitreomacular adhesion (VMA) in     patients 40 years and older using Spectral Domain Optical Coherence Tomography.   "
61400|NCT02481895|"     Between 40% and 60% bipolar patients experience neurocognitive impairment not only during     acute mood episodes but also during remission periods. These rates are quite similar to those     reported as regards to functional impairment. In fact, it is estimated that only one third of     patients achieve full social and occupational recovery and get back to their premorbid     levels. Moreover, neurocognitive deficits, together with other clinical and sociodemographic     variables are thought to contribute to functional impairment for bipolar disorder, similarly     to that found in schizophrenia. Little is published with regard to neurocognitive remediation     in bipolar disorder. The first open label study on bipolar disorder was published in 2010     with positive results. Recently, a multicenter randomized clinical trial coordinated showed     efficacy of an innovative intervention at improving functioning and reducing disability of     bipolar patients. There is a need of investigating novel and creative ways to work on     cognitive deficits including new technologies in order to reduce costs and increasing     benefits for patients. No study addressing computerized cognitive training in bipolar     disorder has been developed so far. This project aims to test the efficacy of an     e-neurocognitive module as an adjunct to functional remediation in bipolar patients.   "
61401|NCT02481882|"     This study will provide information on cortical haemodynamics in MS patients to address the     discrepancies reported in previous literature, allowing further insight into the role of     haemodynamics in the disease. It will also instruct us as to the most effective scanning     protocols for future research. Developing a suitable protocol for studying perfusion     longitudinally may also enable identification of new therapeutic interventions to normalise     any perfusion abnormalities in MS patients.   "
61402|NCT02481869|"     Patients who sustain broken ankles have a very high risk of developing arthritis soon after     injury (within 2 years). This arthritis can cause increased pain and a decrease level of     function, especially if the injury occurs at an early age. During and shortly after ankle     injury, there is an inflammatory chemical process that takes place in the ankle that can     cause damage to the cartilage in the ankle joint. The investigators want to use what is     called Platelet Rich Plasma (PRP), which is produced from a small amount of the patient's own     blood, to inject into the injured ankle to see if they can decrease the inflammation that     happens after the injury and to see if they can decrease arthritis.   "
61403|NCT02481856|"     The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled     multi-site trial conducted in Canada. Before the start of treatment, the subjects will     undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment     duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions     after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after     24 weeks of treatment.   "
61404|NCT02481843|"     Prospective observational study in 40 adult critically ill patients. Patients were eligible     if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and     hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood     transfusions, no renal failure, no chronic obstructive pulmonary disease. Twenty patients     (hyperoxia group) underwent a 2-hour exposure to normobaric hyperoxia (FiO2 1.0), 20 patients     were evaluated as controls. Serum erythropoietin (EPO) was measured at baseline, 24h and 48h.     Serum Glutathione (GSH) and reacting oxygen species (ROS) were assessed at baseline (t0),     after 2 hours of hyperoxia (t1) and 2 hours after the return to baseline FiO2 (t2).     Sidestream dark field videomicroscopy was applied sublingually to assess the microvascular     response to hyperoxia. Near infrared spectroscopy with a vascular occlusion test was applied     at t0, t1, t2.   "
61405|NCT02481830|"     The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy     in subjects with relapsed SCLC.   "
61406|NCT02481817|"     The study is aimed at answering the questions; (1) How well do the most commonly used     treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with each     approach?      With the results of this trial, the investigators hope to provide information to iSGS     patients: (1) Given my personal characteristics, conditions, and preferences, what should I     expect will happen to me? and (2) What are my options, and what are the potential benefits     and harms of these options?   "
61407|NCT02481804|"     This study aims to investigate if optimal personalized consultation by a dietician for a     healthy diet focused on food which contains sufficient vitamins and minerals improves     gastrointestinal symptoms as determined by an improved score in the gastrointestinal symptoms     of the NET specific EORTC QLQ-GINET21 at end of study.   "
61408|NCT02481791|"     What is the optimal maintenance dose of remifentanil to ensure apnoea, during breath hold     episodes in children having cardiac MR imaging with general anaesthesia?   "
61409|NCT02481778|"     Rationale:      Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically     relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In     particular, the relationship between radiation dose parameters and the risk of cardiac     toxicity remains to be determined.      Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long     latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP     and hs-TNT, as obtained during and after treatment may be of great value.      Objective:      The main objective to find a correlation between the rise in NT pro BNP level and the     radiation dose given to the heart.   "
61410|NCT02481765|"     Transcranial direct current stimulation (tDCS) is a method which enables noninvasive     electrical stimulation of the cortex via electrodes placed on the subject's skull. High     definition tDCS (HD-tDCS) allows for precise generation of electrical fields over selected     cortical areas using multiple electrodes. The purpose of this pilot trial is to study     feasibility, tolerability, and safety of HD-tDCS administered daily for a total of 20     sessions in healthy adults and adults with Down syndrome.      PRIMARY OBJECTIVES Part I: To assess feasibility and tolerability of HD-tDCS, administered up     to 5 days per week for a total of 20 sessions in healthy adult subjects; Part II: After     review of the safety data for Part I is completed and reviewed by the Data Safety Monitoring     Committee and IRB, Part II will be initiated. To assess feasibility and tolerability of     HD-tDCS, administered up to 5 days per week for a total of 20 sessions in adult subjects with     Down Syndrome.   "
62933|NCT02461901|"     This study evaluates whether patients with Clostridium difficile infection (CDI) who are     treated with fidaxomicin have less contamination of their skin and surrounding environment     with spores of C. difficile than patients treated with other drugs (metronidazole or     vancomycin)   "
61411|NCT02481752|"     The purpose of this research study is to investigate the effect of a brief computer task     (Approach Avoidance Task) on smoking cessation. The investigators will use a novel training     protocol that works to target automatic thoughts and tendencies that occur outside of     conscious control. Previous research suggests that these automatic tendencies may have a     direct effect on certain health behaviors- like continuing to smoke despite having previous     quit attempts.      The investigators hypothesize that individuals in the AAT training condition will evidence a     greater decrease in reaction times to avoid smoking-related stimuli & approach positive     stimuli relative to those in the control condition. The investigators also expect that     individuals in the AAT condition will exhibit superior outcomes on several quit-related     variables as evidenced by an increase in motivation to quit smoking, an increase in number of     days abstinent following a self-guided quit attempt, an increase in self-efficacy, and a     decrease in urge to smoke compared to those in the SHAM training condition.   "
61412|NCT02481739|"     The aim of the investigators study is to know the results of the endometriosis surgery and     particularly to highlight a benefit of this surgery on fertility.   "
61413|NCT02481726|"     Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the     solitary pulmonary nodules of lung cancer or tuberculosis.   "
61414|NCT02481713|"     Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on     learning styles in improving attendance to cognitive training   "
61415|NCT02481700|"     The aim of this study is to get a clear view on current practice of surgical third molar     removal in Belgium and the association with morbidity and complications.      For this prospective cohort study, patients who visit the outpatient department of Oral and     Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the     Flemish Hospital Network will be participating. All included patients are referred from     primary dental providers for the surgical removal of one or more third molars. Before     participating, written informed consent will be recorded from all eligible subjects.      Patients consult one of the oral and maxillofacial surgeons or residents working on the     department of the University Hospitals Leuven for the removal of third molars. In the     standard procedure, patients are not routinely clinically monitored after one week at the     department.      Pre-operative, operative and postoperative data will be collected through a questionnaire,     extracted data from the patient's medical file and panoramic radiography. The surgeon's     individual operation technique will be registered through a one-off questionnaire. The     questionnaires are taken at the same time of consultation and includes a maximum of 8     questions per time and are considered as non-invasive and a minimal burden for the patient.     Postoperatively, patients record their recovery status and ability to resume daily- and work     activities at day 3 and 7 by using a dairy system and, if necessary, revisit the outpatient     department of oral and maxillofacial surgery.   "
61416|NCT02481687|"     Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that     actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing     endoscopy. The potential role of CLE has been explored in pathology of both upper and lower     gastrointestinal tract, showing good accuracy for predicting the final histopathological     diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its     minute scanning area, this techology is best used in conjunction with other red-flag     techniques to screen the mucosa for areas of interest, which can then be examined by CLE for     a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced     endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have     been no studies to determine the role of this technology in the evaluation of activity in     inflammatory bowel disease. The study protocol is based on comparing imaging findings of     p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of     inflammatory bowel disease. CLE might have an important role in IBD patients management, by     assessing the inflammation, dysplasia or response to treatment.   "
61417|NCT02481674|"     The purpose of this study is to evaluate the safety, tolerability, PK, and efficacy of     VX15/2503 in subjects with late prodromal and early manifest Huntington's disease.   "
61418|NCT02481661|"     Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0     peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic     segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer.     The aim of this study is to investigate whether the outcome of anatomic segmentectomy is     similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).   "
61419|NCT02481648|"     The investigators aim to evaluate the feasibility of a larger clinical trial assessing an     exercise program during the teachable moment in patients with prostate cancer and measuring     its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will     be randomized between a 4-12 week exercise program or to standard of care only. Participants     will be assessed at screening, baseline (day 0), throughout the trial intervention (days     1-84), post-intervention visit (prior to radical prostatectomy) and final study visit     6-months post-radical prostatectomy. At each assessment, physical, biological samples and     psychosocial assessments will take place.   "
61420|NCT02481635|"     This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new     indication/population ) and phase 2 (the second phase in testing a new drug or new     indication/population to see how effective the drug is) study of neoadjuvant (treatment     before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and     radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in     patients with pancreatic cancer that has grown to involve one of the major artery branches.   "
61421|NCT02481622|"     This non-interventional study aims to characterize the cells infected with HIV over time in     different types of vagino-uterine tissue.   "
61422|NCT02481609|"     The purpose of this research study is to evaluate the use of NAC in the treatment of anosmia     (a loss of the sense of smell). This drug is already approved by the Food and Drug     Administration (FDA) for oral or pulmonary (lung) inhaled use for other medical conditions.     However, there is research evidence that the medication may promote nerve recovery (help     nerves work better after they are damaged). Since anosmia involves nerve problems, we believe     the nasal spray may help treat anosmia. The medication has been in use for many years for     other conditions, without safety problems.   "
61425|NCT02481570|"     The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery     will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest     opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid     respiratory depression and allow patients to respond quickly either during intraoperative     testing or at the conclusion of surgery.   "
61426|NCT02481557|"     This study will assess sensitivity during a dental prophylaxis with or without the use of a     potassium oxalate salt solution.   "
61427|NCT02481544|"     Psychosocial factors, including positive affect, finding meaning in the event, and managing     emotional distress, influence prognosis following a heart attack or myocardial infarction     (MI). Gratitude, typically defined as a feeling or attitude in acknowledgment of a benefit     that one has received or will receive, is associated with higher levels of well-being, and     people who are more grateful experience less stress, are less depressed, have higher levels     of control over their environment, and more positive ways of coping. The present project will     examine the potential benefits of a gratitude intervention (i.e., 8 weeks of gratitude     journaling) to increase positive health behaviors, psychological health, and physical     functioning in post-MI patients as compared to journaling about memorable events as well as     care as usual alone. The investigators will study psychological and physical functioning at     baseline, following 8 weeks of gratitude journaling or care as usual, and at 4-month     follow-up.   "
61428|NCT02481531|"     This clinical trial will evaluate the growth, tolerance, and iron status of infants who     consume an investigational infant formula containing a nutrient-rich whey protein compared to     a previously marketed infant formula.   "
61430|NCT02481505|"     This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for     spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower     limb. Patients undergoing elective short-duration lower limb surgery will be randomised into     3 treatment groups (15 patients per group) to receive one of the 3 single doses of     Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.   "
61431|NCT02481492|"     This is a prospect, randomized control trial to evaluate merits between flip and no flip     technique in Shang Ring children circumcision.   "
61432|NCT02481479|"     Diabetes is associated with a substantially increased risk of heart failure, which is     associated with substantial morbidity and mortality. Despite the development of new     therapeutic strategies to improve glycemic control, recent clinical data from the saxagliptin     assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in     myocardial infarction (SAVOR-TIMI) 53 study observed an unexpected finding of an excess of     adjudicated heart failure hospitalizations. This excess occurred in the setting of     pre-existing heart failure (HF) hospitalization and in those with elevated biomarkers for     heart failure such as N terminal pro Brain type natriuretic peptide (NT-pro BNP). A wealth of     preclinical data did not suggest a mechanistic basis for an excess of heart failure events,     however these preclinical studies primarily focused upon prevention based strategies as     opposed to regression studies once established heart failure was present. This proposal seeks     to understand if and how dipeptidyl peptidase-4 inhibitors (DPP4i,specifically saxagliptin)     may influence the development of heart failure, by evaluating changes in cardiac structure     and function using cardiac magnetic resonance imaging (MRI).   "
61433|NCT02481466|"     The purpose of this study is to determine whether a dietary portfolio of cholesterol-lowering     foods (viscous fibres, soy protein, plant sterols and nuts) further enhanced by increased     levels of monounsaturated fatty acids (MUFA) and low glycemic index foods; together with a     structured exercise program reduce the progression of carotid and coronary atheromatous     lesions, Low density lipoprotein-cholesterol (LDL-C), and blood pressure, while reducing the     number of individuals requiring statins.   "
61434|NCT02481453|"     Sporadic Inclusion Body Myositis (IBM) is the most frequent inflammatory myopathy in patients     over 50. It is a slowly progressive, but today untreatable (notably by classical     immunosuppressants) disease.      Rapamycin used in organ transplantation blocks the activity of T effector cells, preserves T     regulatory cells and induces autophagy (protein degradation), all parameters impaired during     IBM.      RAPAMI is a prospective, randomised, controlled, double blind, monocentric, phase IIb trial     evaluating rapamycine against placebo.   "
61435|NCT02481440|"     The purpose of this study is to evaluate the safety and efficacy of intrathecal     administration of allogeneic umbilical cord derived mesenchymal stem cells to patients with     spinal cord injury.   "
61486|NCT02480777|"     The primary purpose of this research study is to determine the safety of injecting ones own     Schwann cells as a supplement along with nerve autograft (eg sural nerve) a few weeks after a     severe injury to the sciatic nerve has occurred.   "
61487|NCT02480764|"     The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil     compared with valsartan in Chinese participants with essential hypertension.   "
61488|NCT02480751|"     The purpose of this study is to determine the recommended dose of the sustained-release form     of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular     disease/nephrosclerosis).   "
61436|NCT02481427|"     Unicondylar knee arthroplasty (UKA) can be used as the treatment of knee OA isolated to a     single compartment instead of TKA. Both UKA and TKA have been used for decades as a treatment     of knee OA. However, operative indications for TKA and UKA overlaps, but they are not     similar. Therefore, the outcome or survivorship of these procedures cannot be compared     directly.      Some advantages of UKA over TKA have been reported, including faster recovery time, reduced     perioperative morbidity and mortality, a subjective preference of feeling more normal knee,     lower cost and improved return to work and sport. On the other side national arthroplasty     registers consistently report around a threefold increase in crude cumulative revision rate     at 8 to 10 years for UKA compared with TKA 7-10.      The aim of this study is to compare functional, clinical, patient satisfaction, and implant     survival results of cementless UKA with those of cemented TKA at 2 months, 1, 2, 5 and 10     years after the procedure. The study design is a multicenter, double-blind and randomized     trial of knee replacement patients. The primary outcome is the Oxford Knee Score (OKS) and     Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 year.   "
61477|NCT02480894|"     This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and     female subjects.        -  For the effect of maraviroc on the PK of BMS-626529 (the active moiety of BMS-663068),          there is no formal hypothesis to be statistically tested. The purpose of this assessment          is to estimate the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 when          coadministered in healthy subjects.        -  For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically          tested is that BMS-663068 will not have a clinically significant effect on the PK of          maraviroc when coadministered in healthy subjects.   "
61437|NCT02481414|"     This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV)     therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing     reagent called Candin®) in adult females over a 12 month time period. As the results from the     Phase I trial demonstrated some efficacy against non-16 HPV types, Candin alone will also be     tested. Therefore, there will be two treatment arms: (1) PepCan and (2) Candin. Subjects     found to be eligible for vaccination will be randomized in a double-blinded fashion at a 1:1     ratio. Each participant will be receiving injections four times with three weeks between     injections. Clinical and virological responses will be assessed at 6 and 12 months. Safety     will be assessed from the time of enrollment to 12 Month Visit. Immunological assessments     will be made at 4 time points (prevaccination, after 2 injections, 6 month after 4 injections     and 12 months after 4 vaccinations).   "
61438|NCT02481401|"     Two Intensive Life Style Intervention Programs in Related Caregivers of Preschool Children      Substantial strides have been made in the treatment of acute cardiovascular conditions, such     as myocardial infarction and stroke, however, the global burden of cardiovascular disease     (CVD) continues to rise at an alarming rate. Furthermore, despite the abundant data     demonstrating a greater burden of CVD in racial/ethnic minorities, and many specific     interventions aimed at changing risk factor patterns or behaviors in racial/ethnic     minorities, health disparities persist. In the present study, the investigators seek to     evaluate the impact of a multifaceted and comprehensive lifestyle intervention coupled with     atherosclerosis imaging on reducing cardiovascular risk among minority adults living in     Harlem, New York. The investigators believe that holistic, multi-dimensional individual and     peer-to-peer intensive lifestyle interventions involving parents/caregivers of preschool     children will be effective in producing favorable change in their behaviors, which will be     sustained over time. The primary hypothesis of the study is that aggressive lifestyle     interventions will be more effective in improving healthy behaviors and biological correlates     in at-risk adult parents and/or caregivers of preschool children in Harlem, NY. In aim 1, as     an initial pilot study, the investigators will identify the contextual factors, facilitators     and barriers that may impact the implementation of a lifestyle intervention program for     adults in Harlem, using qualitative research methods. In aim 2, the investigators will     determine the impact of two intensive lifestyle interventions on promoting and improving     healthy behaviors and biological parameters to lower cardiovascular risk, the impact of the     knowledge of presence of atherosclerosis on health behaviors and the impact of these     lifestyle interventions on atherosclerosis among approximately 600 asymptomatic at-risk     adults. Finally, in aim 3, the investigators will evaluate the sustainability of the impact     of the two intensive lifestyle interventions on healthy behaviors and biological parameters     12 months after the intervention program ends.   "
61439|NCT02481388|"     The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory     muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of     the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of     the present research, a pilot cross-sectional study was conducted with fourteen (14) patients     with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two     groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory     pressure - MIP <70% predicted MIP) and a control group without weakness (CG). The pulmonary     and respiratory muscle functions were assessed by spirometry and manometer, respectively.     Before and after maximal exercise test, optoelectronic plethysmography was performed to     evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall     muscles. The high-resolution ultrasonography was also used before and after the maximum test     for obtaining diaphragmatic thickness   "
61440|NCT02481375|"     Globally, the most common cause of anemia is thought to be iron deficiency anemia (IDA). This     was assumed to be the major cause of anemia in Cambodia, because Cambodian diets, which     consist mainly of rice, lack iron-rich animal food sources. However, our findings from a     previous study in Cambodia (a Canadian government funded study investigating multiple     interventions to improve food and nutrition security) showed that IDA is almost non-existent     and challenges this assumption. In a cross-sectional survey of 450 women from rural Cambodia,     only 1.0% had Hb and ferritin levels indicative of IDA (Hb <120 g/L and ferritin <15 μg/L). A     national survey conducted by UNICEF in 2014 found similarly low rates of IDA (Dr. Arnaud     Laillou, UNICEF Cambodia). Further, other micronutrients known to be associated with anemia     were also low (<3%) including folate and vitamins B12 and B6.      In addition, 54% of the Prey Veng women had a genetic Hb disorder (e.g., α-thalassemias),     which are inherited diseases that can result in a defective Hb structure and/or impair Hb     production, either of which can reduce Hb concentration and increase the risk of anemia.     Further, genetic Hb disorders cause ferritin and soluble transferrin receptor (sTfR)     concentrations to increase, which reduce the diagnostic sensitivity of these biomarkers to     identify IDA.      In 2011, the Cambodian Ministry of Health (MOH) recommended weekly iron and folic acid (IFA)     supplementation for all women of reproductive age, consistent with WHO guidelines. However,     if iron deficiency is not a major cause of anemia, then at best supplementation is a waste of     valuable resources and at worst could cause harm. Further, the justification for provision of     multiple micronutrients among this population has not yet been proven, despite the push from     some organizations such as the WHO. There is an urgent need to conduct a trial to clarify     whether iron or other micronutrient deficiencies are a major cause of anemia in Cambodia.      Research Objectives:        1. To compare Hb concentration (g/L) after 12-weeks of supplementation in women to          determine if iron significantly improves Hb concentration, compared to a placebo;        2. To compare Hb concentration (g/L) across the four groups (multiple micronutrients with          iron, multiple micronutrients without iron, iron alone, and placebo) after 12-weeks; and        3. To determine which of the hematological indicators (ferritin, sTfR, reticulocyte count          and hepcidin) have the strongest diagnostic ability to predict responsiveness to iron          therapy after 12-weeks using receiver operating characteristic (ROC) analyses.      Methods: A 2 x 2 factorial randomized controlled trial will be conducted over 12 weeks. A     total of ~800 women (18-45 y) with mild or moderate anemia will be recruited and randomized     to 1 of 4 groups: multiple micronutrients with iron, multiple micronutrients without iron,     iron alone or placebo. Blood will be collected at baseline and at 1 and 12 weeks after the     intervention and assessed for Hb, hematological biomarkers, inflammation and genetic Hb     disorders. The investigators will use a general linear model to measure differences in Hb     concentration across the four groups after the intervention. Receiver operating     characteristic curves will be used to determine the diagnostic ability of the multiple     hematological indicators to predict responsiveness to iron therapy.   "
61441|NCT02481362|"     This study will examine differences in habituation to foods high in sugar and fat content     versus those that are not, in normal weight women.   "
61442|NCT02481349|"     The goal of this research study is to learn what patients and their caregivers think about a     couple-based Hatha yoga program during treatment for cancer. Researchers also want to learn     how this program may affect fatigue, distress, sleep quality, and quality of life.      Some patients and caregivers in this study will take part in a Hatha yoga program together.     For comparison purposes, there will also be a group of participants that does not take part     in this program.   "
61443|NCT02481336|"     To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the     clinical bioinformatics and genomic profile.   "
61444|NCT02481323|"     Phase II pilot randomised, factorial, short term dose escalation, open label, blinded     intermediary endpoint trial, in two hospital centres in the UK, of tolerability and safety of     cilostazol, isosorbide mononitrate, both or neither in patients with small vessel disease     manifest as symptomatic small subcortical stroke.   "
61489|NCT02480738|"     This study is to investigate the effectiveness of computerized cognitive training, and     corresponding neural substrates through multimodal neuroimaging assessment, in the elderly     with normal cognition, subjective cognitive impairment, and mild cognitive impairment.   "
61541|NCT02480049|"     Comparative randomized, single dose, two-way crossover open-label study to determine the     bioequivalence of Montelukast fromAsmakast10 mg tablets (Man. by Minapharm Egypt for Novartis     Pharma Egypt S.A.E (Sandoz), Egypt) and Singulair10 mg tablets (Produced by Global Napi     Pharmaceuticals, Egypt under license from: Merck & Co. Inc., USA) after a single oral dose     administration of each to healthy adults under fasting conditions.   "
61445|NCT02481310|"     The purpose of this study is to evaluate the effects, good and bad of a new drug called     ixazomib (also called MLN9708), when it is given along with a common treatment combination,     called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase     I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted     (either up or down) to find the maximum (highest) dose that does not cause excessive (too     many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the     maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted     between cycles depending on how blood cell levels are affected between cycles. Ixazomib is     considered investigational because it is not approved by the U.S. Food and Drug     Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the     last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part     of the standard of care.   "
61446|NCT02481297|"     The goal of this clinical research study is to learn if lirilumab in combination with     rituximab can help to control either CLL or SLL. The safety of the drug combination will also     be studied.   "
61447|NCT02481284|"     The purpose of this study was to perform a quantitative perfusion study of the undermined     abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction     patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion     imaging (LDPI) was used to evaluate this.      Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients.     Measurements were taken and recorded within four standardized zones covering the skin between     the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to     caudal).   "
61448|NCT02481271|"     This study aims to test the effects of a Preoperative Relaxation intervention and an     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in     Patients Undergoing Cholecystectomy.   "
61449|NCT02481258|"     The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows     progression of valve calcification in patients with moderate calcific aortic valve stenosis.     Secondary and tertiary objectives are to determine whether Ataciguat slows progression of     aortic valve function, reduces systemic inflammation, and prevents left ventricular     dysfunction in patients with moderate calcific aortic valve stenosis.   "
61450|NCT02481245|"     We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and     safe for bipolar depression with the following specific aims:      Aim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability     of bezafibrate added to lithium for bipolar depression, especially with regard to worsening     manic symptoms and suicidal ideation.      We will conduct a phase IIa, 8-week, open pilot trial of bezafibrate added to lithium in 20     participants with bipolar depression. We will monitor changes in manic symptoms (Young Mania     Rating Scale), suicidal ideation, cognitive functioning specifically in attention and verbal     memory, and treatment emergent adverse events (SAFTEE). We will also monitor changes in the     Framingham Cardiovascular Risk Score.      Aim #2. Preliminary Assessment of Efficacy: To assess the antidepressant efficacy of     bezafibrate added to lithium for acute bipolar I major depressive episodes.      In summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive pan-PPAR     agonist, bezafibrate, for 20 patients with an acute bipolar I major depressive episode. The     study may have a profound impact on the development of a novel treatment consistent with the     mitochondrial dysregulation hypothesis of bipolar disorder and, to the best of our knowledge,     will be the first proof-of-concept trial to assess a pan-PPAR agonist for bipolar disorder.   "
61451|NCT02481232|"     Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy     people above 2-months-old   "
61452|NCT02481219|"     This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON     2 Capsule Endoscopy System (CCE) procedures in average risk patients.      Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam     CCE.   "
61453|NCT02481206|"     A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of     treatment and control. This study will evaluate the impact of wearable cardioverter     defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will     enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.   "
61454|NCT02481193|"     The purpose of this study is to investigate the effects of different doses of cisatracurium     pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.   "
61455|NCT02481180|"     The purpose of this study is to assess the MTD, Pharmacokinetics and preliminary efficacy of     T0001 in Rheumatoid Arthritis.   "
61456|NCT02481167|"     The purpose of this study is to identify age-related changes in chinese meibomian glands that     may be associated with meibomian gland dysfunction (MGD).   "
61457|NCT02481154|"     This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of     AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation.   "
61458|NCT02481141|"     The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC     at doses up to 200 mg per day in subjects with type II diabetes.   "
61459|NCT02481128|"     Sentinel node biopsy is a well established tool for axillary staging in early breast cancer.     So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to     clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective     randomized multicenter study design.   "
61460|NCT02481115|"     The investigators hypothesize that critical care trained registered nurses and physicians can     perform measurements of cognitive impairment in critically ill pediatric patients in a     reliable and valid manner. To test this hypothesis, the investigators will incorporate an     instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in     critically ill pediatric patients at least 6 months to children 5 years of age, both on and     off mechanical ventilation, and compare these assessments to those of the reference standard.   "
61461|NCT02481102|"     The objective of the Registry is to provide post market clinical outcome and potential health     economics data and confirm the continued safety of the EpiAccess system.   "
65030|NCT02434484|"     This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main     objective is to obtain safety information related to Symbenda treatment from clinical     practice.   "
61462|NCT02481089|"     Warburg effect is an important feature of tumors,and genetic variation is one of the main     factors of individual differences to radiotherapy treatment response for nasopharyngeal     carcinoma(NPC). Through the previous work investigators found that the p53 codon72 (Pro/Arg)     was related to the prognosis of NPC; Using the method of proteomics, investigators discovered     glycolysis related gene such as PGK1, ALDOA，was associated with radiosensitivity.Thus,with     all the previous work,investigators hypothesize that the key gene polymorphisms in glycolytic     pathway, such as p53 , influence the glycolytic pathway,which leads to differences in     radiosensitivity of NPC. This projects will include 600 cases of patients with NPC to detect     common glycolytic key genes polymorphisms. Besides,investigators correlate these factors with     their radiosensitivity and prognosis.Then, prediction model will be established, and     validation of the prediction model will be done. Using enzyme-labeling instrument ，comet     assay and clonogenic assay，cytological experiments will further investigate the influence of     key gene polymorphisms on the glycolysis efficiency and mechanism of radiation     sensitivity.Thus,investigators could provide theoretical basis of individualized treatment     for NPC.   "
61463|NCT02481076|"     The aim of this project is to find out if compression treatment can lower the incidens of     surgical wound complications, such as infection and wound rupture, in patients with ankle     fractures. The compression regime consists of a two-layered compression stocking applied     after surgery and a massage boot applied both before and after surgery.      The largest part of the study is the clinical trial, with which we aim to prove the     hypothesis:      * That the compression regime reduces wound infections from 10-40% to 5% on patients with a     broken ankle (Either one side of the ankle, two or three sides (including the posterior part     of the ankle))   "
61464|NCT02481063|"     This study evaluates the changes in muscles and tendons in the lower limb after an     intervention of fatigue during 3 consecutive days between trained or not healthy subjects.     One of the 2 groups received training by eccentric overload previously.   "
61465|NCT02481050|"     This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate     administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with     HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.   "
61961|NCT02474550|"     This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL)     treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will     prospectively collect clinical data and treatment outcome of patients with DLBCL who use     prophylactic pegylated-filgrastim.   "
61466|NCT02481037|"     At least half of children with asthma have poor disease control, which can result in     complications requiring emergency treatment and hospitalization. As asthma is one of the most     common reasons for children to visit emergency departments (ED) and be hospitalized, this     disease places a heavy burden on the health care system and families. While there is strong     evidence that timely treatment with preventative therapies can substantially improve asthma     control, reduce sudden worsening of symptoms, and lower rates of ED visits and     hospitalizations, a significant proportion of children do not receive these therapies.      The purpose of this study is to improve the prescription and use of evidenced-based     preventative therapies for children with asthma with the goal to significantly improve their     disease control and quality of life, while reducing unnecessary ED visits and     hospitalizations. The investigators will achieve this by: i) installing a primary care     clinical pathway for managing childhood asthma into clinicians' electronic medical record     (EMR) to facilitate the use of best-evidence by practitioners, and ii) training chronic     disease management (CDM) health professionals to provide targeted and timely asthma education     to parents and children with asthma. The investigators will test this pathway and education     project in a representative sample of 22 Alberta primary care practices, using a pragmatic     cluster controlled trial methodology.   "
61467|NCT02481024|"     Background:      Medication adherence following acute coronary syndrome (ACS) is often sub-optimal. Poor     adherence is associated with increased risk of rehospitalisation along with higher rates of     morbidity and mortality. After a cardiac event, transitioning from hospital into primary care     can be problematic if it is not organised or coordinated properly. Patients can often find     themselves unprepared and lacking the necessary information for self-management of their     disease. The impact of care transition on medication adherence has not been studied in ACS.      Objectives:      This study will explore how an ACS patients' journey from hospital into primary care affects     medicines use. Further, to understand how medicine information is communicated and how this     influences patient beliefs about medicines.      Methods:      This is an interview study with recently hospitalised ACS patients discussing medication     beliefs, communication of medicine information and the challenges when transitioning from     specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS     Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An     inductive thematic analysis will be used to identify, construct and analyse patterns in the     data and to develop a framework analysis. Analysis will be an iterative process conducted in     parallel with data collection to highlight when data saturation has been reached.      Dissemination:      The primary objective is to develop a pharmacist-led behaviour change intervention to improve     rates of medication adherence following an ACS. The in-depth patient data collected in this     current study will contribute to the design and development of the intervention.     Understanding the research topic from the patients' perspective is a necessity when designing     an intervention targeting behaviour change.   "
61468|NCT02481011|"     The true incidence and risks of intracranial hemorrhage (ICH) in patients on various     antithrombotic treatments remain unknown. Here a nationwide study is conducted to investigate     the risk for and incidence rates of ICH in users and non-users of various oral antithrombotic     drugs in Norway between 2008 through 2014.      Hopefully, this study will contribute to a more responsible prescription pattern of     antithrombotic medications.   "
61469|NCT02480998|"     This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent     vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in     healthy Korean males and females 19 to < 65 years of age.   "
61490|NCT02480725|"     The study hypothesis is that that the deleterious effect of prions on the brain may be     mediated (at least partially) by activation of serine proteases involved in the coagulation     system. If this is true, then measurement of the activity of the coagulation system may be a     marker of disease onset (in at higher risk individuals such as E200K* carriers) and for     disease progression or activity in affected individuals. In addition, modulation of the     coagulation system activity may be a potential tool for therapeutic intervention.      *E200K- E200K mutation (Glu to Lys substitution) in the prion protein gene   "
61491|NCT02480712|"     The primary objectives of this study are to evaluate the efficacy, safety and tolerability of     treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV     infection who were coinfected with HIV-1.   "
61470|NCT02480985|"     Damage to the pituitary gland is a frequently overlooked but potentially important     complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause     dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur     immediately or several months after TBI, may delay recovery and may have a significant     negative impact on quality of life. TBI is the leading cause of disability and major     permanent functional impairment among adults under 45 years of age. Hormonal deficits may     contribute to common symptoms experienced by TBI survivors such as fatigue, poor     concentration, depression and low exercise capacity. However, the association between     hormonal deficits and disability remains uncertain. The primary objective of this pilot study     is to assess the feasibility of a larger study that will evaluate the impact of pituitary     disorders on neurological disability and functional recovery. The results of this study will     provide key findings in the impact of pituitary disorders following TBI, which is a mandatory     step prior testing the effect of hormonal replacement therapy in this population in costly     clinical trials. If no relationship between pituitary disorders and disability is observed,     the investigators' findings will prevent unnecessary, time-consuming and costly hormonal     screening and will discourage potentially harmful hormonal therapy.   "
61471|NCT02480972|"     The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI     for investigating difference between normal or early fibrosis and advanced fibrosis.   "
61472|NCT02480959|"     The purpose of this study is to determine whether medial patellofemoral ligament     reconstruction results in superior functional outcomes compared to medial retinacular     plication surgery in cases of recurrent patellar instability.   "
61473|NCT02480946|"     Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent     of patients don't respond to current treatments. MBS2320, the drug being tested in this     trial, represents a new approach to treating RA, with the potential not only to reduce levels     of inflammation but to also directly inhibit bone damage.The aim of this study is to test the     safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change in the blood     with dose, and to test the safety and compatibility of giving MBS2320 to patients with RA in     combination with an existing treatment, methotrexate.   "
61474|NCT02480933|"     The aim of this study is to define silent breast cancer prevalence in both sexes and will be     held by biopsies performed in imaging suspicious areas of the breast (ecography and     mammography) in cadavers without known breast cancer.   "
61475|NCT02480920|"     This study will compose a national database of drug adherence and investigate the factors     that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish     Population.   "
61476|NCT02480907|"     The purpose of the Supporting Carers of Children and Adolescents with Eating Disorders in     Austria (SUCCEAT) - study is to compare Workshop, Internet-based and Conventional Parental     Support Groups for carers of chilren and adolescents between 10 and 18 years in a randomized     controlled trial for the first time in Austria.   "
61478|NCT02480881|"     This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI)     study in healthy female subjects on oral contraceptives (OC). There is no formal research     hypothesis to be statistically tested. It is expected that coadministration of BMS-663068     with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or     norethindrone (NE).   "
61480|NCT02480855|"     A vital question for society in general and primary health care in particular is early     identification of persons at risk of sickness absence due to work-related stress. Even though     both the individual and society can gain a lot from the prevention of absence, not the least     since return to work is costly once a person is sick-listed. There is, surprisingly enough,     no established method to do this. This project is a randomized controlled study of people     with mental disorders and physical complaints consulting primary care. The purpose is to     evaluate if a systematic use of early identification of work-related stress, combined with     feedback at consultation, at the primary health care centers can prevent sickness absence     among employed women and men with common mental disorders and subjective physical health     complaints.   "
61481|NCT02480842|"     Introduction: physical therapy is essential in preventing motor and functional complications     after breast cancer surgery. However, there is no prospective randomized study of different     physiotherapy approaches in patients undergoing breast cancer surgery with immediate     reconstruction. Objectives: to evaluate two physical therapy protocols in patients after     breast cancer surgery with immediate reconstruction. A group with shoulder exercises with     limited range of motion (ROM) at 90 degrees up to a month after surgery and a group with     limited ROM only up to 15 days after surgery. Specific objectives: to evaluate shoulder ROM     and pain one week before the surgery on average, and 07, 15, 30, 60, 90 and 180 days after     surgery; assess motor function one week before the surgery on average, and 30 and 90 days     after surgery; evaluate dehiscence and seroma 07, 15, 30, 60 and 90 days after surgery;     associate incidence of seroma and dehiscence with preoperative risk factors and compare all     variables (shoulder ROM, pain, motor function, seroma and dehiscence) between the two groups.     Methods: women with breast cancer, who will be submitted to breast surgery (radical or     conservative), followed by immediate reconstruction: alloplastic (tissue expander or breast     implant) or oncoplastic (breast reduction or contralateral symmetrization) will be included.     Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous     tissue or breast surgery without reconstruction will not be included. Patients will be     recruited just after surgery scheduling and will undergo preoperative evaluation. At this     moment, preoperative analysis will be conducted with personal data and medical history.     Patients will undergo new assessments 07, 15, 30, 60, 90 and 180 days after surgery. All     patients will receive standard physiotherapy treatment for women undergoing breast     reconstruction from Physical Therapy Sector. The protocol consists of early exercise, limited     to 90° of shoulder ROM, starting the day after the surgery and repeated 7 days after surgery.     After 15 days of surgery, the patients will be randomized into two treatment protocols. One     group will start to perform exercises with free shoulder ROM. Patients will be told only to     limit the movement if they feel pain. The other group will keep shoulder exercises limited to     90° up to 30 days after surgery. At that moment (one month after surgery), they will also be     allowed to move the shoulder with no restriction. The evaluation of the presence of     dehiscence and seroma will occur by inspection and palpation. Shoulder ROM will be     investigated through active goniometry of flexion, extension, adduction, abduction, internal     rotation and external rotation. The pain will be assessed with the Verbal Numerical Scale     from 0 to10 and upper limb function through the DASH (Disabilities of the Arm, Shoulder and     Hand Questionnaire) questionnaire.   "
61482|NCT02480829|"     Two Phase Multicenter Study to Evaluate Safety and Efficacy of the Amphora OAB system for     treatment of urgency and frequency with or without urge incontinence caused by an overactive     bladder.   "
61483|NCT02480816|"     The effects of consuming a sodium-bicarbonated mineral water rich in bicarbonate, sodium,     chloride, lithium and silicon are studied in humans. The aim of this assay was to determine     whether the consumption of this water as part of the usual diet, reduces cardiometabolic risk     factors in adult men and women.   "
61484|NCT02480803|"     Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are     accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no     comparative studies have been executed. The INVEST study is an open label randomised     controlled trial with cost-effectiveness as primary outcome. Secondary outcomes will be     quality of life, neurological impairments, among others.   "
61492|NCT02480699|"     Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions.     It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are     implicated in cardiovascular complications associated with CKD. Several protein-bound toxins     have been implicated in the increased cardiovascular risk such as indoxyl sulfate (IS), p     cresol sulfate (pCS) and more recently the indole acetic acid (IAA). All clinical studies are     performed with a single measurement at baseline assuming that the toxin levels are stable     over time. The variability of uremic toxins level is not known. Furthermore, little is known     concerning determinants of serum toxins level.   "
61493|NCT02480686|"     This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV     genotype 1b treatment-experienced patients.   "
61494|NCT02480673|"     The objective of this study is to evaluate the effect of the administration of 25 g of chia     per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with     this condition   "
61612|NCT02479126|"     The primary objective of this research project is to describe the characteristics, diagnosis,     management, and outcomes of patients with Interstitial Lung Disease (ILD) who received care     at the Veteran's Administration Veterans Integrated Service Network (VISN) 6 Mid-Atlantic     Health Care Network (VISN6) (includes North Carolina, Virginia and West Virginia) for up to 5     years.   "
61495|NCT02480660|"     Purpose: To understand the baseline knowledge on the transition of care to adult providers in     hospitalized adolescent patients and to test if an educational intervention given during an     inpatient stay in a medium size academic pediatric hospital affects perception of knowledge,     attitudes and participation in transition planning.      Primary Research Question: Will a video-based educational intervention in an academic     pediatric hospital affect perception of knowledge, attitudes and participation in transition     planning to adult oriented health care of the hospitalized adolescent?      Secondary Research Question: What is the baseline experience of the hospitalized adolescent     in key elements of transitioning to adult oriented health care?   "
61496|NCT02480647|"     Randomized clinical trial the use of levonorgestrel releasing intrauterine system.      Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine     system l(LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the     control of chronic pelvic pain and / or dysmenorrhea in women endometriosis.   "
61497|NCT02480634|"     This study will give comparison of the bone pain remission and the adverse reaction of     Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic     acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial is     to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in     treatment of non-small cell lung cancer bone metastasis'pain relief or not.   "
61498|NCT02480621|"     This study is a randomized controlled trial assessing pain control in ankle fractures     repaired with open reduction and internal fixation. Patients are consented and enrolled     pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine     administered intra-operatively.   "
61499|NCT02480608|"     The study will test the tolerability and efficacy of the combination therapy     Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic     phase (CP1) newly diagnosted or failing interferon-based therapy.   "
61500|NCT02480595|"     The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective,     registry designed to collect on-label data in real world clinical settings on patients     undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft     System. Registry data will augment existing data from ongoing and prospective Aorfix™     clinical trials for the purposes of publication, general product development and quality     measures.   "
61501|NCT02480582|"     The current study will examine the effect of almond consumption (0.9g/kg dose) compared to an     energy and weight matched comparator food or no food on measures of appetite control     including appetite sensations, energy intake and food hedonics.   "
61502|NCT02480569|"     The investigators propose a single center prospective study that will assess two different     strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing     clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be     measured with a non-side hole guide catheter (with the guide catheter both engaged and     disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide     catheter both engaged and disengaged from the coronary ostium) to determine, whether     measurements obtained with an engaged side-hole guide catheter are more accurate as compared     with those obtained with the engaged non-side hole catheter.   "
61503|NCT02480556|"     to compare the blood loss during caesarean section between two different methods of     separating the placenta after fetal extraction, keeping in mind that most blood loss occurs     after placental separation.   "
61504|NCT02480543|"     A randomized clinical trial to assess the effectiveness of same-day cervical preparation with     oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.   "
61505|NCT02480530|"     The purpose of this research study is to improve statin medication adherence among Veterans     with coronary artery disease with poor adherence to medications. The investigators are     testing if newer technology pill bottle devices linked with individual feedback and/or social     incentive strategies can improve medication taking behavior.   "
61506|NCT02480517|"     The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled     feasibility study of the safety of renal denervation in patients with stage I and II     hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and     have not been on any antihypertensive medications for at least six months.   "
61507|NCT02480504|"     A randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk     factors of intermittent energy restriction and a isocaloric continuous energy restriction in     obese subjects.   "
61508|NCT02480491|"     Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for     Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.   "
61522|NCT02480296|"     The purpose of this study is to establish safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized,     double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose     study in healthy volunteers aged 18-55 years.   "
61509|NCT02480478|"     Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is     a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy.     ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an     increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive     and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders     or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of     serum autotaxin activity in cholestasis of pregnancy.   "
61510|NCT02480465|"     Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by     Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.   "
61540|NCT02480062|"     Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low     detection rates, inadequate use of evidence based interventions and low adherence with these     interventions. Primary health care is the appropriate setting for improving the prevention     and management of these chronic conditions. The investigators will develop and evaluate an     innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a     patient health profile, decision support for clinical care, monitoring and feedback for use     in Indian Community Health Centers (CHCs). The investigators will conduct this research     following the steps proposed by the medical research council (MRC) for evaluation of complex     interventions. Technical development of m-WELLCARE will be conducted, user acceptability     appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two     states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health     care received and changes in risk factors achieved will be evaluated.   "
61511|NCT02480452|"     The overall goal of this research proposal is the early prediction of the emergence of CVI     and its characteristics on the basis of neuroimaging data.      The different steps that will be taken to achieve this goal will be:        1. To characterize CVI deficits in children;        2. To correlate the CVI characteristics with their motor profiles;        3. To characterize brain lesions in children with CVI;        4. To link the motor profile, CVI profile and brain metrics of the children.      Over the last 10 years, 488 children with and without CP have consulted at the CVI clinic in     Leuven. All these children had a comprehensive visual perceptual assessment, cognitive     evaluation and an ophthalmological assessment. Summarizing these data results in a     quantitative visual perceptual profile for each individual patient. The goal is to     prospectively extend this database to a number of 600 children. The project's primary     objective is to relate the presence of CVI to the motor profiles of these children.      Of these 488 children, 300 have an MRI available. The goal is to analyze the retrospective     MRI data of this clinical group and to prospectively extend this database by reassuring newly     registered children will receive MRI with DTI. This will allow the investigation of the     correlation between the brain metrics and the CVI characteristics in a large cohort.   "
61512|NCT02480439|"     The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet     compared with a TAK-648 oral solution, and to assess the effect of food on the     bioavailability of a TAK-648 tablet in healthy participants.   "
61513|NCT02480426|"     To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography     during transjugular intrahepatic portosystemic shunt (TIPS) creation.   "
61514|NCT02480413|"     The purpose of this prospective single center study is to investigate if a developed     algorithm is more accurate than the pediatric emergency tape (Alpha 1 Werbedesign e.K.,     Falkenberg, Germany). For this study 500 patients are required to collect anonymized data     (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of     80% during statistical analysis. The main hypothesis ist that the algorithm has a better     accuracy than the pediatric emergency tape (53% are in a +/- 10% interval).   "
61515|NCT02480400|"     To evaluate the effect of visit number, patient expectation, and rater expectation of the     efficacy of escitalopram treatment in fixed doses of 10 and 20mg, based on baseline severity     in patients with MDD.   "
61516|NCT02480387|"     Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C     virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and     have HCV RNA < 6 x106 IU/mL      Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment:     treatment   "
61517|NCT02480374|"     This dose escalation study will determine a maximum tolerated dose and/or optimal biological     dose of GEN-1 for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer.   "
61518|NCT02480361|"     Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is     being accepted in the West as a treatment option for managing POI and various functional     gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to     evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who     underwent gastric surgery for a later large-scale study.   "
61519|NCT02480348|"     The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free     Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary     arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and     3.50 mm in diameter.   "
61520|NCT02480335|"     The aim of the study is to investigate whether bosentan added to usual care improves arterial     stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large     arteries corrected for blood pressure changes in patients with systemic sclerosis (SSc) with     digital ulcers (DU). Patients will be randomized into a group with usual care and bosentan     (n=20) or usual care only (n=20). PWV will be assessed at baseline, 3 months and 12 months.   "
61521|NCT02480322|"     Background: Obesity is associated with multiple diseases. Bariatric surgery is the most     effective therapy for severe obesity that cannot only reduce body weight but also     obesity-associated morbidity.      Objective: The metabolic alterations associated with obesity and respective changes after     bariatric surgery are incompletely understood.      Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based     global, untargeted metabolomics strategy on human serum samples that were collected before     and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy,     proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also     analyzed serum samples from normal-weight and less obesity obese subjects that were matched     for 1-year postoperative BMI values of the surgical groups.   "
61542|NCT02480036|"     The primary objective is to evaluate the tolerability (side effects) of the intraoperative     radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord     damage, and pathological fracture), and the secondary objective is to evaluate the     effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor response).   "
61543|NCT02480023|"     BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams     Maternity hospital.   "
62247|NCT02470832|"     The study is being conducted to investigate the effect of itraconazole treatment in the     pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response     relationship and the safety and tolerability of RG1662 when given in combination with     itraconazole in healthy subjects.   "
61524|NCT02480270|"     This study plans to learn more about the effect of oral antibiotics for an outpatient     pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung     function, airway inflammation and quality of life. In this study subjects will perform     pulmonary function tests, provide a sputum sample and complete a questionnaire at two     separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will be     asked to breathe in a salt water solution to help cough up sputum. The first sputum sample     will be obtained at the first visit (within 48 hours of starting antibiotics). Pulmonary     function testing and the questionnaire will also be completed at this time. Subjects will     complete a two week course of oral antibiotics at home. During these two weeks subjects will     be asked to write down the times antibiotics are taken and airway clearance (vest treatment)     is performed. Within one week of completing the antibiotic course subjects will return to     clinic for a second visit. At that time a sputum sample will be obtained again and if     subjects are unable to cough up sputum they will again be asked to breathe in salt water     solution to help cough up sputum. Pulmonary function testing and the questionnaire will also     be completed at this second visit. Sputum samples will be tested for infections with bacteria     and viruses. Sputum samples will also be used to measure markers of airway inflammation     (swelling). The investigators hypothesize that the use of two weeks of oral antibiotics for     the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria     measured in sputum. Additionally the investigators hypothesize that treatment with     antibiotics will lead to an improvement in lung function, a decrease in airway inflammation     and an improvement in quality of life measurements.   "
61525|NCT02480257|"     The investigators aim to refine and pilot test an innovative group treatment model for     adolescent depression and anxiety, Training for Awareness, Resilience and Action (TARA) in a     sample of 14-18 year olds with depressive or anxious symptoms.   "
61526|NCT02480244|"     This is a cluster randomized trial (CRT) to assess the effectiveness of a culturally     appropriate behavioral intervention to reduce obesity levels and ultimately the risk of     developing diabetes type II in immigrant Latino farm workers. Randomization is at the farm     ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the     work-site on diabetes, diet and physical activity and optional supplemental sessions in the     evening and weekends. The investigators will adopt the intent-to-treat principle for the     primary analysis. Individuals on control ranches will receive no health educational     instruction. The primary outcome is BMI. The investigators hypothesize that intervention     ranches will achieve significant improvement in obesity and diabetes risk factors as compared     to control ranches.   "
61527|NCT02480231|"     Prospective randomized clinical trial comparing two methods of intra-operative tensioning of     retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of     abnormal bladder function. Secondary outcomes include validated quality of life scores,     physical exam findings, and rates of immediate post operative voiding dysfunction.   "
61528|NCT02480218|"     Breast cancer is the most frequently diagnosed cancer in women with the majority receiving an     endocrine therapy (ET) in the adjuvant setting. ETs dramatically reduce recurrence and     improve survival but given the aging population and increased survivorship, there are growing     concerns regarding the cognitive effects of ETs since estrogen is neuroprotective. A critical     unanswered question is whether there are differences in cognitive decline between the two     classes of ETs, selective estrogen receptor modulators (SERMs - tamoxifen) and aromatase     inhibitors (letrozole and anastrozole), in older women at greater risk of hormone receptor     breast cancer and cognitive decline. Before a large multicentre observational study can be     undertaken the investigators are proposing a feasibility study to establish metrics on     participation, retention and adherence rates and parameter estimates to inform sample size     calculation required to detect cognitive differences between the two ET classes. A     convenience sample of chemotherapy-naïve patients, aged 65 and older, with early stage     disease, 25 on a SERM and 50 on an aromatase inhibitor, will be assessed cognitively at     baseline and after one year.   "
61529|NCT02480205|"     There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is     preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal     continuous positive airway pressure (CPAP) or nasal intermittent positive pressure     ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed     end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain     in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed.     Considering that preterm infants are more likely to develop atelectasis, an active and     ongoing management of the PEEP is very important to prevent de-recruitment.      A new respiratory support system (NeuroPAP) was developed to address these issues     (synchronization problems and control the PEEP). It uses the electrical activity of the     diaphragm (EDI) to control the ventilator assist continuously, both during inspiration     (principle of NAVA mode) and also during expiration (based on tonic Edi level).   "
61556|NCT02479854|"     Comparative randomized, single dose, two-way crossover open-label study To investigate the     bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg     chewable tablets(Merck & Co. Inc. ), after a single oral dose administration of each to     healthy adults under fasting conditions,   "
61857|NCT02475941|"     The investigators will be looking at geriatric distal femur fractures. The investigators will     prospectively enroll these patients and allow patients to either weight bear as tolerated or     limit their weight bearing post operatively. The investigators will evaluate functional     outcomes.   "
61530|NCT02480192|"     Women going through the menopausal transition often experience adverse physical changes     (e.g., hot flashes/night sweats, sleep difficulties, sexual concerns) in addition to     emotional difficulties (e.g., depression, anxiety) that can significantly impact functioning     and overall quality of life. To date, hormone therapy (HT) has been the most commonly used     treatment to relieve symptoms of menopause. However, reports have questioned the safety of HT     long-term (e.g., risk of heart attacks, strokes, cancer) in some women. Cognitive-behavioural     therapy (CBT), has been proposed as a low-risk treatment for menopausal symptoms and received     some initial support. The investigators developed a comprehensive non-pharmacological, CBT     based treatment program for menopausal symptoms, published the treatment manual, and have     initial evidence supporting its effectiveness with the investigators' published pilot data.     The investigators' goal is to conduct a large randomized controlled trial of Cognitive     Behavioural Group Therapy (CBGT) for the improvement of menopausal symptoms. The     investigators hypothesize that participants will experience fewer and less intense/disruptive     hot flashes/night sweats, reduced depression and anxiety and improvement in sleep     difficulties, sexual concerns, and overall quality of life. The investigators also predict     that these benefits will be maintained at follow up and there will be high satisfaction     associated with the program by participants.   "
62248|NCT02470819|"     The primary objective is to examine the impact on progression-free survival of targeted     therapy for breast cancer suggested by proteomic and genomic profiling.   "
61531|NCT02480179|"     The investigators plan to evaluate H.E.G. (Hematoencephalography) modality in brain     modulation of appetite and food craving in a randomized controlled study. The H.E.G. will     serve as the neurofeedback modality while the functional brain imaging will enable assessment     and hopefully validation of changes brain activity related to food craving and self-control.     H.E.G. is a relatively new neurofeedback technique which similar to fMRI, is based on changes     in blood oxygenation level as a result of regional brain activation. The unique advantage of     this technology regarding our enterprise is that it inheritably samples the two brain areas     that are in our focus of interest: the superior orbito-frontal cortex (OFC) which Involved in     self-control and reward processing, and the anterior cingulate cortex (ACC) which processes     cognitive and emotional information. The investigators will combine HRV (Heart rate     variability) biofeedback, which is a well-established treatment form in the investigators     therapeutic sessions and will correlate functional neuroimaging with behavioral,     anthropometric and laboratory data.      The intervention name is: Measurements of blood flow changes within the brain and online     visual feedback to the participant by a H.E.R. (Hematoencephalography) N.I,R (Near Infra Red     sensor) sensor made by MindMedia, The Netherlands and a NEXUX4 Hardware, Bluetooth unit, Bio     Trace Plus software made by MindMedia, The Netherlands.      Hypothesis: The neurofeedback practice sessions are expected to facilitate improved control     of blood flow to frontal brain areas, as a marker of brain activity in these areas   "
61532|NCT02480166|"     The primary objectives of this study are to describe the efficacy of:        1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6        2. 12-week treatment of SOF/LED for all other HCV-6 populations   "
61533|NCT02480153|"     The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab     in combination with methotrexate in subjects with moderately to severly active rheumatoid     arthritis who have had an inadequate response to methotrexate.   "
61534|NCT02480140|"     Emerging research suggests the use of self-regulation (SR) strategies at improving functional     regain in patients with brain injury. SR is proposed to produce an added effect to the     effective constraint-induced movement therapy (CIMT). This study aimed to examine the     efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with     subacute stroke. It was hypothesized that participants receiving the combined treatment (SR     and CIMT) would have a better functional regain.   "
61535|NCT02480127|"     Repeated implantation failure (RIF) is determined when failure of implantation occurred     during at least three consecutive IVF attempts while at least one high-grade embryo was     transferred in each cycle. Several methods have been suggested to improve the implantation     rate in RIF patients. One of the most promising methods is local injury to the endometrium.     It has been reported that the rates of implantation, clinical pregnancy, and live birth reach     more than double in RIF patients with local endometrial injury than patients without it. The     population of this study included all infertile couples attending the Royan Institute, who     have at least three consecutive cycles of ART failure. Also this study is phase 3 randomized     clinical trial. Based on the average menstrual cycle 30-28 days, endometrial and blood     samples were collected from two groups of patients on day 21 of luteal phase of their     spontaneous menstrual cycle. The intervention, but not the control group underwent prior     biopsy treatment in follicular phase on days 8 or/and 11 to 13 of that same cycle but in     these days blood sample in both groups were collected. To investigate the impact of local     endometrial injury in increasing the rate of pregnancy in ART - treated RIF patients, the     investigators will examine the changes of immunological factors involved in the implantation     including some cytokines, growth factors ( in serum and endometrial biopsies) and the     expression of TLRs and HOX genes ( in endometrial biopsies) obtained from both groups.   "
61536|NCT02480114|"     This randomized phase III trial studies how well gabapentin plus standard of care work     compares to standard of care without Gabapentin in preventing inflammation of the mucous     membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing     primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and     neck may cause a burn involving the inside of the mouth, throat, and nasal passages,     resulting in pain. Gabapentin may help prevent (or minimize) pain associated with     radiation-induced mucositis in patients with head and neck cancer.   "
61537|NCT02480101|"     This is a single centre phase I, double-blind placebo-controlled study to assess     reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9)     influenza vaccine in healthy male and female adults, 18 through 49 years of age .   "
61858|NCT02475928|"     The purpose of this study is to evaluate the effect of zinc supplementation in the treatment     for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.   "
65031|NCT02434471|"     The purpose of this study is to evaluate a single breath hold abdominal MRI protocol and     compare the image quality of respiratory triggered 3D T1-weighted images against conventional     breath hold images.   "
61538|NCT02480088|"     Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control,     however, its use inevitably increases the incidence of postoperative nausea and vomiting     (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention     and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the     prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3     antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study     evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using     IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of     the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48     h will be assessed. ABCB1 polymorphisms 3435C>T and 2677G>T/A will be evaluated in all     patients.   "
61539|NCT02480075|"     The purpose of this study is to (a) evaluate the treatment approaches and changes in     treatment regimens utilized by clinicians when genetic testing is performed in the clinic;     and (b) create a patient data registry to identify genetic factors that influence treatment     outcomes in pain management.   "
61544|NCT02480010|"     This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in     participants with hormone-refractory prostate cancer who have had no previous chemotherapy.     Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and     the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50     participants may enter either cohort, for a total enrollment between 46 and 73 participants     across 9 study centers.   "
61613|NCT02479113|"     Besides maternal hyperglycemia, a strong link between maternal pregravid weight/maternal     triglyceride(Tg) levels and fetal growth/childhood obesity/metabolic syndrome in offspring     has been demonstrated in largely Caucasian populations. This study aims to explore the link     between maternal hypertriglyceridemia and offspring health in Asians.   "
61545|NCT02479997|"     This study aimed to compare detection rate between dual sentinel node staining method using     mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.      To identify the first lymph node(s) along the lymphatic drainage pathway from the primary     tumor in the breast cancer using RI only has several disadvantages such as invisibility,     interference. As ICG can be visualized with a fluorescence imaging system, we expects dual     sentinel lymph node staining method had better outcomes.   "
61546|NCT02479984|"     The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients     with potentially resectable pancreatobiliary cancer.   "
61547|NCT02479971|"     A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve     gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups:     those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those     undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2).     Postoperative pain and C reactive protein will be investigated 24 hours after surgery.   "
61548|NCT02479958|"     Despite of the decline of dental caries, this disease is still common in polarized groups     affecting children. Therefore, the aim of this randomized blind in vivo study was to compare     the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty     two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin     lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and     resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy     (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and     RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The     patients were submitted to initial clinical and radiographic examination and demographic     features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and     radiographic follow up at 6 and 12 months after the treatments. The carious dentin was     collected before and after each treatment and the number of Streptococcus mutans,     Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and     total bacteria were established by quantitative PCR.   "
61549|NCT02479945|"     The investigators will compare tumor marker levels, including PSA, in samples taken from a     peripheral upper limb vein and the internal iliac veins. These will be collected from     patients who are scheduled for prostatectomy as part of their standard of care for prostate     cancer. A selective internal iliac vein sampling procedure will be performed in     Interventional Radiology. Venous samples will be correlated with prostatectomy specimens. The     aim is to predict the side of the prostate containing tumor.   "
61550|NCT02479932|"     The aim of study is to compare skin-to-delivery time and postoperative morbidity between     extraperitoneal cesarean and transpirational cesarean.   "
61551|NCT02479919|"     The purpose of the study is to test a new treatment of social cognition deficits in patients     with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation     (theta-burst). The study will also identify clinical, psychomotor and cognitive variables     that are the most sensitive to treatment, and estimate the most sensitive treatment target     between patients.   "
61552|NCT02479906|"     The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS     (DTMS) for the treatment of PTSD.   "
61553|NCT02479893|"     Given the limited existing data regarding the advantages and limitations of the existing     techniques in the removal of colonic polyps the investigators designed a prospective study in     order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal     of colonic polyps of the left colon up to a diameter of 0.8cm.   "
61554|NCT02479880|"     To characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label     tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This     includes prospectively evaluating and comparing the bone mineral density (BMD) change between     CHB-infected adolescents 12 to < 18 years of age treated with tenofovir DF in European     treatment centers who are assigned to one of two schedules for renal and bone laboratory     monitoring and BMD measurement.   "
61555|NCT02479867|"     Comparative randomized, single dose, two-way crossover open-label study to determine the     bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham     Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets (Kahira     Pharm &Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration of each     to healthy adults under fasting conditions.   "
61557|NCT02479841|"     Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and disability,     and by 2020, it is expected to be the third leading cause of mortality worldwide. COPD is a     major public health concern and has considerable impact on health and quality of life.      For this study an evidence based self-management program is developed, the purpose of the     study is to see if this self-management program, in collaboration between specialized health     services and municipality health services, improves patients with COPD health-promoting     competence, coping and quality of life, and reduces health service costs.The study has a RCT     design.   "
61558|NCT02479828|"     This study evaluates the effect of fascia iliaca compartment block (FICB) in the management     of acute post -surgical pain in hip fracture patients and in the appearance of chronic post     -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in     Greek.      Half of the patients will not receive fascia iliaca compartment block.   "
61569|NCT02479685|"     This prospective randomized pilot study is aimed to verify if the operative time of a     standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment     of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic     loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD     (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic     morcellator.   "
61628|NCT02478918|"     This is a quality improvement study to determine the impact of an automated telephone     reminder on the quality of bowel preparation in patients undergoing outpatient colonoscopy.   "
61559|NCT02479815|"     The purpose of the study is to assess the safety of iron supplementation in MNPs. A     quasi-experimental matched-control cluster design will be used in, purposely selected, 18     intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and     People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from     intervention and non-intervention clusters will be enrolled and followed longitudinally for     12 months. Morbidity data using standardized questionnaire, will be collected at baseline,     and every two weeks for a period of 12 months      Research questions to be answered in this study are:        1. Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young          children with or without iron deficiency safe, as assessed by their morbidity from          infectious diseases?        2. What is the impact of the provision of low dose iron-containing Micronutrient Powders          (MNPs) to young children on (body) iron status? Morbidity data will be collected at          baseline, and every two weeks in the same cohort of children.      Body iron status will be assessed at baseline and endline as measured by serum ferritin,     serum transferrin receptor, hemoglobin concentration, CRP and AGP.      In addition data on the following outcomes will be collected in these children:        1. Anthropometry (weight, height, MUAC) every 4 months        2. Breastfeeding status and consumption of processed complementary food portions in the          previous week -every 4 months        3. Compliance to study intervention.   "
61560|NCT02479802|"     Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5%     albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic     Lateral Sclerosis (ALS).   "
61561|NCT02479789|"     Intra operative Nerve Monitoring ( IONM ) is rapidly becoming the standard of care for     thyroid surgery to prevent injury to the recurrent laryngeal nerve. However the laryngo     tracheal reflexes need to be adequately suppressed to permit proper utilization of intra     operative nerve monitoring. Increasing the depth of anesthesia to achieve this often leads to     side effects. Intravenous lidocaine infusion has been shown to be effective in blunting these     reflexes. The planned study intends to look at the efficacy of intravenous lidocaine infusion     in decreasing the amount of anesthesia medications needed to suppress the reflexes. Also the     study looks at the analgesic and anti emetic properties of intravenous lidocaine infusion     post operatively by measuring these outcomes.      The study is designed as a double blinded randomized controlled trial with 30 subjects in the     group who will receive intravenous lidocaine during surgery and 30 subjects in the group who     will receive placebo. Blunting of the laryngo tracheal reflexes intra operatively will be     recorded as the primary outcome. The amount of anesthesia medications, the post operative     patient comfort level, pain control, usage of narcotic pain medications, nausea, vomiting     will be recorded as secondary outcomes.   "
61562|NCT02479776|"     The bone marrow mononuclear cell fraction has been used as therapy after myocardial     infarction and in dilated cardiomyopathy in adults. The absence of adult co-morbidities may     enhance the potential effectiveness of pediatric stem cells.This study is a randomized,     crossover, placebo controlled pilot study to primarily determine the safety and feasibility     of stem cell intracoronary therapy in children. Secondary end points are MRI measurements and     NTproBNP.      Ten children (mean age 7.2 years, range 2.2-14.1, 6 male) with dilated cardiomyopathy (NYHA/     Ross Classification 2-4) will be recruited. Bone marrow aspiration MRI and cell injection are     performed under the same anaesthetic. Patients will be crossed over at 6 months.   "
61563|NCT02479763|"     In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%.     This stems from the prevalence of trainee operators coupled with the non-specific nature of     loss-of-resistance. In the current randomized trial, we will set out to compare conventional     and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research     hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease     the failure rate of thoracic epidural blocks.   "
61564|NCT02479750|"     This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold     symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy     volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will     receive placebo.   "
61580|NCT02479542|"     The worldwide prevalence of open wounds is estimated to be approximately 200 million per     year. Negative Pressure Wound Therapy (NPWT), the application of a controlled vacuum to an     open wound cavity, has been clinically demonstrated in developed nations to speed the healing     time of open wounds by a factor of two or more, and to aid in complete recovery with less     scar tissue. Use of NPWT devices has not been feasible in an limited-resource settings due to     cost, bulk, and requirement for consistent electricity. This study aims to follow up prior     clinical studies that have established the safety and efficacy of simplified NPWT, by     assessing changes in wound closure time and wound contraction rate when simplified NPWT is     used in a limited-resource setting.   "
61565|NCT02479737|"     Postoperative bleeding is a common consequence after heart surgery which can significantly     impact outcomes and costs [Wynne R, Christensen MC, Dixon B]. When bleeding occurs, reliable     postoperative blood evacuation of the pleural, mediastinal and pericardial spaces with chest     tubes is imperative to facilitate pulmonary re-expansion and mediastinal decompression as the     patient recovers. When postoperative blood evacuation is inadequate, retained blood     complications can result (herein described as the Retained Blood Complications (RBC). RBC is     the presence of post-operative pericardial and/or pleural fluid or blood that is diagnosed     and may necessitate drainage in the acute or sub-acute setting. The need for treatment and     interventions for these conditions represents an impediment to patient recovery and involves     both resource and economic consumption for a heart program and the healthcare system at     large.      Clinically, Retained Blood Complications (RBC) can be recognized acutely or subacutely. When     it presents acutely, it is usually fresh thrombus around the heart or lungs presenting as     tamponade or hemothorax. When it presents subacutely, it results in bloody pleural or     pericardial effusions. These effusions are often driven by the breakdown of remaining     thrombus. Once RBC occurs, subsequent procedures may be needed to remedy it.      A recent review of the literature indicated that additional procedures for RBC are     demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively     collected United States Nationwide Inpatient Sample (NIS) data from 2010, RBC could be     demonstrated in 17% of patients. In this analysis, mortality was doubled from 4% to 8%,     length of stay was increased by 5 days, and average costs were 55% higher. Patients with RBC,     therefore, represent an increased at risk population for complications and costs.      Postoperative obstruction of conventional chest tubes with blood and other fibrinous material     in the setting of postoperative bleeding contributes to RBC. (Shalli) In a recent study of     postoperative cardiac surgery patients at the Cleveland Clinic, 36% of patients were found to     have evidence of chest tube obstruction . Active Clearance with PleuraFlow has been shown to     prevent chest tube clogging, and reduce RBC.   "
61566|NCT02479724|"     Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and     Intra-Arterial Catheters in ICU Patients   "
61567|NCT02479711|"     The aim of the present study is to evaluate the clinical performance of EQUİA restoration     material in Class II cavities comparing with a resin-based composite / dentin bonding system.   "
61568|NCT02479698|"     The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)     can help to control BK viral infection and JC viral infection. Researchers also want to learn     about the safety of giving CTLs to patients with BK and/or JC infection.      CTLs are made from donated blood cells that are grown in the laboratory and are designed to     kill viruses that can cause infections.   "
61596|NCT02479334|"     This study aims to investigate the effect of spices on gene expression of pathways associated     with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in     healthy human subjects.   "
61570|NCT02479672|"     This is a prospective randomized clinical study to be performed in adult patients ages 18 and     older who are undergoing surgical procedures requiring endotracheal intubation. Adult     patients will be randomized to either the VideoTrac® laryngoscope or direct laryngoscopy and     the time to intubation will be compared and recorded. Patients in both treatment arms will     receive manual inline stabilization. The study hypothesis is that the time to endotracheal     intubation will be decreased in the VividTrac® video laryngoscope group when compared to     direct laryngoscopy.   "
61571|NCT02479659|"     This randomized evaluation measured the impact of two levels of support for the integration     of infant and postpartum maternal HIV testing with routine immunization services in Southern     Zambia on the number of postpartum maternal HIV tests, infant HIV tests, and 1st dose     diphtheria, pertussis, and tetanus (DPT1) vaccines.   "
61572|NCT02479646|"     This is a single center, double-blind, randomized, comparative pharmacokinetic and     pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy     Volunteers.   "
61573|NCT02479633|"     Background: The aim of present clinical study was to evaluate the predictive values of     baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and     inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of     single gingival recession (GR) defects treated with coronally advanced flap and connective     tissue graft technique (CAF+CTG).      Material and Methods: The study group included 65 females and 57 males, aged between 20 and     42 years. A total of 122 recession defects without CAL and with an amount of CAL equal or     smaller to the buccal CAL , located at upper and lower incisors and canines were treated with     CAF+CTG. IPH, AERSA and CAL parameters were analyzed for possible correlation with CRC after     6 months.   "
61574|NCT02479620|"     This is a prospective, multi-center, randomized pilot study to document the effects of     adventitial delivery of dexamethasone after atherectomy-based revascularizations of lesions     below the knee in symptomatic patients with critical limb ischemia (CLI).   "
61575|NCT02479607|"     The purpose of this study is to evaluate the effects of an interactive Information and     Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients     treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical     management will be improved and costs reduced and safe and participatory care promoted, when     patients report symptoms in an application which provides self-care advice and instant access     to professionals.   "
61576|NCT02479594|"     In a randomized controlled study design, n = 58 treatments of patients with depression were     to be conducted under a feedback-condition, in which the therapist would receive feedback     five times within 20 treatment sessions. The competence-feedback includes detailed feedback     about 14 different aspects of therapist behavior. The control group includes n = 58 further     treatments within which therapists do not receive any competence-feedback (treatment as     usual; TAU).   "
61577|NCT02479581|"     This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional     postoperative care in patients with heart valve disease undergoing cardiac surgery with     cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other half     will under the conventional postoperative care.   "
61578|NCT02479568|"     The primary aim is to examine both the acute and chronic effects of hesperidin consumption     from 100% Florida orange juice in various doses on functional and systemic markers associated     with cardiovascular disease (CVD) risks.   "
61579|NCT02479555|"     This is a prospective, multi-center, randomized pilot study to document the effects of     adventitial delivery of dexamethasone after balloon angioplasty of lesions below the knee in     symptomatic patients with critical limb ischemia (CLI).   "
61581|NCT02479529|"     After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound     hypotension associated with a decrease in systemic vascular resistance. The care of this     disease is based on the intravenous administration of a vasopressor, usually norepinephrine.     During the recovery phase, weaning of norepinephrine, is an important step in which any lack     of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.   "
61582|NCT02479516|"     The investigators are adopting an intervention which has been tested in Canada to the     Philippine setting. The program will be called Community Health Assessment Program in the     Philippines (CHAPP). The main goal of CHAPP is to decrease diabetes and its complications by     implementing a community-based program.      The CHAPP intervention will be modified so that it will be applicable to the Philippine     setting and other Low and Middle Income Countries. The initial plan for the program is that     trained volunteers or health workers will be running the CHAPP sessions 2-hours a week in a     community location for residents in the community. During the CHAPP session, volunteers will     administer a questionnaire and do basic measures (assessing the weight, height, blood     pressure, waist measurement). The questions can be entered into a laptop/tablet/cell-phone or     written into a paper questionnaire depending on the abilities of the volunteer to use     computers. Based on the data gathered, the volunteers will identify residents who have a high     risk of developing diabetes (including long term complications of diabetes such as     hypertension), educate them regarding what to do to avoid having diabetes (by doing exercise,     improving their diet, and avoiding unhealthy lifestyle), and refer them to local health care     when needed. Residents who have high risk of developing diabetes will be referred to have     their blood sugar checked. Residents who have diabetes or complications of diabetes will be     checked to see if they are being treated properly; if not they will be referred to the local     doctor for treatment and medication. All the information regarding the CHAPP sessions will be     sent to the Local Public Health Office or other designated local health centre so that they     will be able to educate, monitor, and attend to residents who have diabetes or who have high     risk of developing diabetes.   "
61583|NCT02479503|"     The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.   "
61610|NCT02479152|"     The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to     investigate haemodynamics generated by the standard mechanical external chest compression     device (LUCAS™ 2) compared to a new version generating chest compressions and active     decompression above the initial starting position of the suction cup (LUCAS™ 2AD).   "
61611|NCT02479139|"     The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment     of primary axillary hyperhidrosis.   "
61584|NCT02479490|"     This is a multicenter prospective study that includes all patients with metastatic Renal Cell     Cancer (RCC) pre- treated with VEGFR TKI in eight Italian cancer centers.      Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil     in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice     daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs     will be self-administered orally, continuously from Day 1 (Visit 2) until progression of     disease, unacceptable toxicity, death or discontinuation for any other reason.      A treatment cycle consists of 28 days.   "
61585|NCT02479477|"     The quality of life and daily activities can be affected by muscleskeletal pain and one of     the forms of assessment is through the SF-36 questionnaire. The investigators know that the     working kinesitherapy is a way to improve the quality of life.   "
61586|NCT02479464|"     The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm     that has been designed to improve the effectiveness and safety of antidepressant medications     by providing guidance in medication selection and appropriate dosing. This algorithm has been     incorporated into a new genotyping interpretative report. This report is now available from     AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four     informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome     P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor     gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo     clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.   "
61587|NCT02479451|"     This clinical trial examines whether nasal theophylline administration can improve olfaction     and nutrition in hemodialysis patients.   "
61588|NCT02479438|"     The purpose of this registry is to evaluate information to determine which operations and     treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus     or digestive tract are providing the most benefit including the long-term effects of     treatment (or no treatment) and the progression of the disease over time.   "
61589|NCT02479425|"     Several studies were searched the preventive measures of bed sores. Although repositioning is     the mainstay in most preventive measures, there is no evidence to recommend specific turning     regimen.      The aim of this study is to comparative the impact of the two points repositioning in lateral     lying position on the right and left versus the traditional three points repositioning on the     right, back, and left in the occurrence of bed sores.      This study was conducted on 150 patients admitted to the critical care department of     Alexandria Main University Hospital after obtaining an informed consent from their relatives.      The investigators excluded patients who: have active or healed bed sores.      Patients were randomly divided into two groups by allocated randomization:        -  Group 1: traditional three points rotation.        -  Group 2: two points rotation.   "
61590|NCT02479412|"     This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled,     multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once     daily by inhalation, in patients with mild to moderate asthma.   "
61591|NCT02479399|"     The objective of this survey is to confirm the safety of Suglat Tablets   "
61592|NCT02479386|"     This study seeks to better characterize relationships between visual function and the     progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration     (AMD). The study is also intended to generate new information on the relationship between     genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study     enrolling participants with GA secondary to AMD. The study visits are scheduled to occur     every 6 months. The anticipated duration of the study is up to 48 months. There is a planned     interim analysis around the 2-year time window for the study.   "
61603|NCT02479243|"     Collateral circulation supports brain tissues to maintain blood perfusion in cerebral     ischemic stroke and are of great benefit for a better outcome. A non-invasive approach     relative to currently widely used digital subtraction angiography (DSA) is needed. ASL     (arterial spin labeling) is a novel perfusion method without contrast agent injection and     features both temporal and cerebral blood flow(CBF) information. The investigators applied     multiple post labeled delay(PLD) time to pseudo-continuous Arterial Spin Labeling (3D pCASL)     MRI and subtraction images were obtained to evaluate the collateral robustness and     quantitatively assess the collateral perfusion in patients with unilateral middle cerebral     artery atherosclerotic stenosis and the ability to predict future stroke recurrence.   "
62404|NCT02468791|"     The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and     the reference product - MabThera® (rituximab) and to demonstrate comparative safety and     tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with     moderate to severe active rheumatoid arthritis.   "
61593|NCT02479373|"     This research is being done to see if resistance exercise (RE) is safe and has a positive     effect on children and young adults with juvenile idiopathic arthritis (JIA).      JIA is an inflammatory autoimmune disease that can cause severe impairment and disability.     JIA can cause bone loss and decreased muscle strength. The medications used to treat JIA can     also have negative effects on growth and development, strength, and ability to function. RE     is performing movements in a slow and controlled fashion (i.e., no speeding up or using force     in the lifting and lowering of the weight) to lessen force on the joints and tissues. This     study will be using Ren-Ex exercise equipment to perform RE.      Currently the American College of Rheumatology recommends exercise for patients with     arthritis. This exercise includes range of motion exercise to protect joint mobility as well     as low resistance and aerobic exercise (AE) to protect muscle mass, bone health, and fitness.     However, a recent study showed no major differences in functionality or quality of life     between patients who performed AE and those who did not perform AE. There is a need for more     data on the impact of RE on children with JIA. Children and young adults aged 10 to 21 with     juvenile idiopathic arthritis may join.   "
61594|NCT02479360|"     Neurofibromatosis 1 (NF1) is a common inherited condition that affects the skin, bone and     nervous system. The complications of NF1 are widespread and can lead to varied difficulties     dependent on the location of neurofibromas and their secondary complications. At present     evaluation of the effect of treatments in NF1 is based on a clinician's neurological     assessment, magnetic resonance imaging and positron emission tomography but it is apparent     that imaging results do not always link with clinical and functional changes in an     individual. This study aims to evaluate the reliability (stability) of a range of functional     standardised outcome measures in adults with NF1.   "
61595|NCT02479347|"     The development of surgical site infections (SSI) in clean-contaminated surgery is regarded     as being preventable. Known to be effective in the prevention of surgical site infection are     the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic     prophylaxis where indicated, and certainly the preparation of the skin at the incision site,     since the patient's skin is the principal source of bacterial contamination of the wound.     This study aims to investigate the efficacy in prevention of surgical site infection in clean     surgery, using two different standardized methods of skin preparation: povidone-iodine 10%     aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70% isopropyl     alcohol in a single-dose applicator. To reduce the variables involved, a single-center study     will enroll a homogeneous population, undergoing breast cancer surgery.   "
61597|NCT02479321|"     Crude incidence rate in Spain of hip fracture in people over 65 years was 511 cases per     100,000 in 2002. About 30% of patients die in the first year. Cardiocirculatory complications     during and after surgery partly explain this high morbidity and mortality. Most patients are     frail and with multicomorbidity. Perioperative Goal-Directed Hemodynamic Therapy (PGDT) based     on noninvasive continuous monitoring of blood pressure, heart rate, oxygen saturation,     cardiac output, cardiac index, stroke volume and stroke volume index can reduce perioperative     complications and improve survival. The objective of our study is to assess the efficacy of a     goal-directed hemodynamic therapy during the perioperative period in reducing intraoperative     complications, especially hemodynamic instability, postoperative complications and 1-year     survival. Patients and Methods: non-randomized intervention study with a historical control     and 1-year follow-up. Patients older than 64 years with non-traumatic hip fracture requiring     surgical intervention. In the control group blood pressure, heart rate, oxygen saturation and     clinical situation besides respiratory parameters were recorded at intervals of 15 minutes.     In the intervention group PGDT based on noninvasive monitoring will be performed. The main     outcome will be the percentage of patients with hemodynamic instability complications and the     average of complications per patient. Secondary outcomes: intraoperative complications,     postoperative complications and survival at 12 months of surgery.   "
61598|NCT02479308|"     This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as     well as evaluate the safety and tolerability of ALKS 5461.   "
61599|NCT02479295|"     This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal     dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor     of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters,     however, are unclear. The investigators design an adequately powered randomized controlled     study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary     objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of     catheter dysfunction that requires intervention. The investigators estimate that they would     need to enroll 132 incident peritoneal dialysis patients in each group for the study to have     80% power to detect a difference between 7% and 15% in the primary endpoint of catheter     dysfunction requiring intervention.   "
61600|NCT02479282|"     Effect of natural cesarean section in comparison to traditional cesarean section on maternal     and fetal recovery.   "
61601|NCT02479269|"     The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on     serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with     cardiovascular disease. Patients were divided randomly into two groups: control and     experimental aerobic group. This study was done with two - stage blood sampling: at the     beginning and at the end of the treatment phase. All subjects were requested to avoid any     exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C -     reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein.     Blood samples for subsequent measurements were frozen immediately and transported to the     Hormone Laboratory for serum separation. The experimental group did the aerobic exercise     programs for 8 weeks for 3 sessions per week and the control group did not receive any     training. After completion of training, the final blood samplings were performed. Exercise     intensity according to the heart rate remained stable until the last week. Brain Natriuretic     Peptide and C - reactive protein levels were measured by ELISA tests. All statistical     analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05   "
61602|NCT02479256|"     Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with     PCOS.   "
67764|NCT02398747|"     The primary objective of this study is to investigate the safety and tolerability of     continuous and/or intermittent dosing of AZD2014 when given orally to patients with advanced     solid malignancies.   "
61604|NCT02479230|"     This pilot clinical trial studies the safety of a dendritic cell vaccine when given with     gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the     breast and local lymph nodes to other organs in the body. The vaccine is made up of natural     cells found in the blood, called dendritic cells, and peptides, or small fragments of protein     which are loaded onto the dendritic cells. This combination may help activate the immune     system against stromal cells, which are cells that help cancer cells survive in the body.     Gemcitabine hydrochloride is a chemotherapy drug that is given before the vaccine to help     shrink the tumor and control cells that may interfere with the activity of the vaccine.     Interfering with the stromal cells that help support the growth of cancer cells may lead to     the death of the cancer cells.   "
61605|NCT02479217|"     The primary objective of this study is to observe safety and tolerability of Xeloda as used     in medical practice, alone and in combination with docetaxel.   "
61606|NCT02479204|"     The aim of the study is to investigate the safety of the concomitant administration of     ACT-334441 with cardiovascular drugs.   "
61607|NCT02479191|"     The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center     post-market registry to evaluate the low profile Ovation ® Abdominal Stent Graft Platform     when used in the endovascular treatment of female patients.   "
61608|NCT02479178|"     BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients     with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the     biliary tree and squamous cell carcinoma of the head and neck.      Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.   "
61609|NCT02479165|"     The aim of this randomized controlled study is to shed light on the analgesic properties and     side-effect profile of an opiod-based regimen as opposed to an Ibuprofene based regimen.   "
89228|NCT02118155|"     The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity     laser therapy associated with connective tissue grafts to treat gingival recession.   "
61614|NCT02479100|"     The aim of this study is to determine if the addition of Contrast Enhanced Spectral     Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient     management - discharge, follow-up, surgery or treatment - being made sooner than it would if     the patient had followed the standard course of investigations and review.      The investigators also intend to compare CESM with MRI. Images and pathology results from     patients who undergo both CESM ans MRI will be reviewed retrospectively for detection of     abnormality and identification of type of abnormality, i.e. is it a cancer or not?   "
61615|NCT02479087|"     The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot)     in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with     inhibitors, including patients at high risk of failure.   "
61616|NCT02479074|"     In this study the investigators wish to explore the difference in 24 hr. cough counts     measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks     treatment with either montelukast or prednisolone in patients with an NO measurement of ≥30     ppb at screening.   "
61617|NCT02479061|"     The purpose of this observational study is to determine the proportion of patients with a     score greater than 3/10 to the questionnaire PALLIA-10.      This questionnaire is a tool provided by the French Society for Palliative Cares, aiming at     helping the providers of care to identify patients who would require palliative cares.      According to the notice of the questionnaire, patients with a score greater than 3 would be     taken in charge by a palliative care team. Considerong the 10 itmes of this questionnaire, it     seems that a large majority of patients would have a score greater than 3 in the context of     anti cancer centers.      To date, palliative teams are not designed to take in charge such an amount of patients.   "
61618|NCT02479048|"     The primary goal is to characterize the acute effects of avocado intake on glycemic and     satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary     goal is to investigate risk factors for cardio-metabolic disease.   "
61619|NCT02479035|"     The purpose of this study is to investigate the relative bioavailability and     absorption/kinetic profile of red raspberry polyphenols consumed with a meal and further to     determine the relationship of these findings on meal-associated metabolic- oxidative- and     inflammatory- responses in relatively insulin sensitive and insulin resistant individuals.   "
61620|NCT02479022|"     This trial is conducted in Europe. The aim of the trial is to investigate the safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy     subjects.   "
61621|NCT02479009|"     Aim:      The aim of this study is to analyze if fluoroscopy is as accurate as computed tomography in     diagnosing displacement of acute scaphoid waist fractures.      Primary null hypothesis:      Fluoroscopy has comparable sensitivity, specificity, accuracy, positive and negative     predictive values compared with computed tomography for the diagnosis of displacement of     acute scaphoid waist fractures.      Secondary null hypothesis:      All fractures diagnosed as non-displaced and treated without surgery are healed on     radiographs and discharged from care within 6 months of injury.   "
61622|NCT02478996|"     This study will evaluate, if an intensive individually adaptated training program via online     supervision during neoadjuvant therapy will improve lung function and reduce pulmonary     complications following esophagectomy for Barrett's cancer.   "
61623|NCT02478983|"     The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5     supreme LMA compared to proseal LMA for infants weighing <10kg.   "
61708|NCT02477878|"     A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual     disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of     increasing doses of BPX-501 T cell infusions to achieve a clinical response. AP1903 will be     investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose     that can mitigate GvHD and preserve the graft-versus tumor effect.   "
61709|NCT02477865|"     This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning     to include approximately 387 T2DM patients who have received at least 8 weeks of treatment     with diet control and exercise； have not received any glucose-lowering agents within the 8     weeks prior to screening; and have inadequately controlled blood glucose.The subjects would     receive PEX168 or placebo monotherapy for 52weeks in total.   "
61624|NCT02478970|"     The corneal endothelium plays an important role in regulating stromal hydration and     maintaining the transparency of the cornea. For evaluating the cornea, the most important     parameters are corneal endothelial morphology and central corneal thickness. The specular     microscope does this. The image in specular microscope is obtained by the specular reflex at     a regular, smooth-surfaced interface of two refractive indices, with the angle of the light     passing into the cornea equal to the angle of reflection to the observer. To obtain a clear     image, the endothelial apical surface must be smooth and uniform and the cornea must be     transparent. Nowadays different types of specular microscope exist.      The investigators propose to compare the endothelial cells with two specular microscopes: the     Konan SP4000, which is the current model and used for standard of care, to the Nidek CEM-350,     which is a newly marketed device.      The investigators would like to evaluate the patients in the clinic and have assessments     completed with both specular microscopes.      Nidek will be loaning the specular microscope, NIDEK CEM-530, for the study.   "
61625|NCT02478957|"     This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in     adult patients with indolent systemic mastocytosis (ISM).      The purpose of the study is to determine the efficacy and safety profile of PA101 delivered     via eFlow high efficiency nebulizer in patients with ISM who are symptomatic despite using     standard treatments.   "
61626|NCT02478944|"     Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel     disease (IBD) to evaluate osophageal motility before and during therapy      Material and methods: The investigators prospectively perform manometry in patients with or     with symptoms consistent with IBD. The investigators evaluate esophageal motility with high     resolution manometry before, during and after IBD therapy. Clinical data are also collected     to find possible correlations. The study do not modify the planned IBD therapy, but observe     motility findings.   "
61627|NCT02478931|"     The purpose of this study is to learn more about personalized cancer therapy including     response to treatment and side effects. Information about the tests and treatments a person     received, or will receive, for their cancer will be collected from medical records to help     the researchers determine whether or not patients respond better when their physicians choose     to treat them according to the genetic makeup of their tumor. Optional research tests may be     performed on tissue, body cavity fluid, blood or urine provided, discarded biological samples     taken during routine care that would normally be disposed of and not saved, or on blood     samples collected for this study. These research tests will be used to create a profile of     the collected specimens which will describe unique characteristics about the genes involved     in a person's cancer. The tests will also help researchers look for biomarkers that may help     predict how people respond to treatment.   "
61629|NCT02478905|"     The epidemiology and transmission dynamics of influenza in hospitals are only poorly     understood, particularly with respect to subjects without symptoms of influenza infection     (e.g. without fever, cough, sore throat, nasal congestion, weakness, headache, loss of     appetite, or myalgia). Knowledge about whether asymptomatic subjects are able to transmit     influenza is of major importance. If they do transmit influenza, vaccination of patients and     healthcare workers (HCW) before start of the influenza season, the permanent use of masks by     HCW during influenza season, and quarantine for previously exposed inpatients may be the only     available measures to reduce the number of influenza transmission events from asymptomatic     subjects in acute care hospitals.      The investigators' key aim is therefore to define whether exposure to asymptomatic subjects     with influenza infection constitutes a risk for influenza transmission in an acute care     hospital setting through active, prospective surveillance.      The investigators' secondary aims are to describe the prevalence of community-acquired     symptomatic and asymptomatic influenza upon hospital admission and the incidence of     asymptomatic and symptomatic nosocomial influenza among inpatients; to assess transmission     dynamics of symptomatic influenza infection in acute care; and to study the incidence of     asymptomatic and symptomatic influenza, absenteeism (i.e. being absent from work due to     influenza), presenteeism (i.e. being present at work despite influenza infection) associated     with influenza, and compliance with infection control recommendations to prevent spread of     influenza in acute care HCW.      The investigators plan to enroll 1,260 inpatients and 180 HCW from medical wards at the     University Hospital Zurich in a prospective study over two consecutive influenza seasons in     order to detect at least one transmission event from an asymptomatic individual shedding     influenza virus. Flocked mid-turbinate nasal swabs will be collected daily from consenting     inpatients starting from day of admission until two days after discharge and from HCW over     the influenza (winter) season and analyzed for influenza A and B using polymerase chain     reaction. Simultaneously, signs and symptoms of influenza infection (including cough, sore     throat, fever >37.8°C, nasal congestion, weakness, headache, loss of appetite or myalgia) as     well as contact patterns between inpatients and HCW will be recorded. Reconstruction of     influenza transmission chains will be based on phylogenetic analyses derived from     next-generation sequence data and epidemiological contact tracing.   "
61630|NCT02478892|"     The study is a prospective, observational, case-control study evaluating the utility of     endoscopic ultrasound for the identification of preneoplastic and neoplastic pancreatic     lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2     mutations.   "
61631|NCT02478879|"     The purpose of this study is to determine which of two delivery methods of Parathyroid     Hormone (PTH) is preferred by patients after 14 days of use for each.   "
61632|NCT02478866|"     BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl     kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against     c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This     first-in-human study is conducted to assess the maximum tolerated dose (MTD) and     dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary     anti-tumor activity of BPI-9016M with single doses and multiple doses.   "
61633|NCT02478853|"     The prevention and control of lifestyle-related non-communicable chronic diseases, including     diabetes, obesity and cardiovascular disorders, that share common risk factors, has now     become a major focus of the World Health Organization. Lifestyle modification, like     improvement of diet, physical activity and tobacco cessation, is the corner stone of diabetes     and cardio-metabolic chronic diseases (CMCD) prevention and management. Under the leadership     of decision-makers of our regional health Agency in order to improve accessibility and     quality of care, our team has collaborated to the development and implementation of an     integrated care framework for the prevention and management of cardio-metabolic chronic     diseases in primary care. This new care framework is currently being implemented in the     context of community health centers (fall 2014) and family medicine groups (spring 2015),     with the support of a Quebec Ministry of Health grant. The current research proposal aims to     evaluate the implementation of this new care framework and explore its impact in the primary     care context. This project is very important as it will generate knowledge on new models of     care integrating preventive and management interventions in primary care settings, in     continuum with specialized health care services and their implementation in an entire region.   "
61634|NCT02478840|"     The overall objective is to evaluate the long-term efficacy of Lamazym i.v. treatment in     patients with alpha-Mannosidosis previously enrolled in Lamazym trials and currently     receiving the treatment according to the AfterCare Program.   "
61635|NCT02478827|"     Schizophrenia is associated with a wide range of symptoms impacting a number of different     domains, including cognitive impairment. Given the array of cognitive deficits associated     with schizophrenia and their relationship to daily functioning, numerous research groups have     examined the impact of cognitive remediation on many aspects of cognition. However, it is     currently unclear as to which domains of cognition should be targeted to produce the most     widespread and durable benefits for schizophrenia patients. It may be the case that targeting     lower-level cognitive processes that are important for higher-level and more complex aspects     of cognition may produce the most widespread benefits in cognition and everyday functioning.     Relatively few studies have examined the effects of working memory or processing speed     training on individuals with schizophrenia, as most studies examine broad-based remediation     programs. Thus, there is a need for targeted working memory and processing speed training     studies to better understand the mechanisms of cognitive enhancement through training in     patients. This study will aim to: 1) investigate near-transfer gains associated with working     memory and processing speed training in schizophrenia patients, 2) investigate far-transfer     gains associated with working memory and processing speed training (i.e., gains in other     neurocognitive domains and social cognition), and 3) investigate real-world gains associated     with training (i.e., gains in daily functioning). Towards this aim, 81 schizophrenia patients     will be recruited and randomly assigned to a working memory training group, a processing     speed training group, or a no training control group. Training will be completed at home for     30 minutes per day, 5 days per week, for a total of 10 weeks. Neurocognitive, social     cognitive, and daily functioning measures will be administered both pre- and post-training to     detect training-related gains.   "
61636|NCT02478814|"     Protein requirements in active individuals have been suggested to be greater than the current     recommended dietary allowance (RDA).      Nutritional requirements for dietary amino acids in adults have traditionally been determined     utilizing the nitrogen balance technique, which is prone to underestimating protein     requirements. As a result, there is a need to re-evaluate recommendations in order to     characterize how dietary amino acid needs may be modulated by physical activity.      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique     have suggested that protein requirements in young men are at least 50% higher than the RDA     based on nitrogen balance data.      The purpose of this study is to measure the protein requirement in active, young adult males     using the IAAO technique in the presence of a variable intensity exercise stimulus.   "
61637|NCT02478801|"     Protein requirements in individuals who participate in endurance-based exercise training have     been suggested to be greater than the current recommended dietary allowance (RDA).      Nutritional requirements for dietary amino acids in adults have traditionally been determined     utilizing the nitrogen balance technique, which is prone to underestimating protein     requirements. As a result, there is a need to re-evaluate recommendations in order to     characterize how dietary amino acid needs may be modulated by physical activity.      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique     have suggested that protein requirements in young men are at least 50% higher than RDA based     on nitrogen balance data.      Therefore, the purpose of this study is to measure the protein requirement in endurance     trained adults using the IAAO technique.   "
90232|NCT02104999|"     Study to test the technical accuracy and userfriendliness of a Point-of-care C Reactive     Protein device (POC CRP device) in comparison with laboratory CRP testing in nursing home     residents   "
61638|NCT02478788|"     The main purpose of this study is to see the affects of the study medication called mixed     amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The     researchers also want to see if MAS-XR makes your child more or less likely to develop     problems like acting out (i.e. periods of irritability, agitation, aggression).      MAS-XR is approved by the United States Food and Drug Administration (FDA) to treat attention     deficit hyperactivity disorder (ADHD) in adults, children and adolescents.   "
61640|NCT02478762|"     In a previous study, the investigators established the dosage of foetal glycated hemoglobin     (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also     compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and     determined that newborn of women with GDM had significantly higher FGH that newborn of women     without GDM.      In this study, the investigators want to compare the FGH of newborn of GDM women randomized     to a group reaching the Canadian Diabetes Association recommended blood glucose objectives     treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower     blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)   "
61641|NCT02478749|"     The purpose of this study is to determine the effect of arm retraction on the supraclavicular     approach for subclavian vein catheterization in adults and children.   "
61642|NCT02478736|"     Postoperative delirium is an important problem in patients undergoing major cardiac surgery     and associated with more complicated hospital course, increased hospital length of stay and     total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is     associated with postoperative delirium after on-pump cardiac surgery. Another study showed     that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity     in the left middle cerebral artery (MCA) preoperatively are at greater risk for postoperative     cognitive dysfunction (POCD). Therefore, the investigators hypothesize that lower     perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good     predictors of the postoperative delirium in the patients undergoing the on-pump cardiac     surgery.   "
61643|NCT02478723|"     A post market, observational study evaluating the treatment of 1st and 2nd molars indicated     for root canal therapy and treated with the Sonendo GentleWave System and obturated with     CPoint and BC Sealer in at least one canal.   "
61644|NCT02478710|"     The purpose of this study is to determine if administering inhaled antibiotics directly into     the lungs in conjunction with intravenous (IV) antibiotics leads to better outcomes and     decreased recurrence of ventilator associated pneumonia (VAP) when compared to IV antibiotics     alone.   "
61645|NCT02478697|"     Previous findings indicate elevated risk for tobacco use among adults in California who are     unemployed and seeking work. In a pilot study, tobacco use was associated with a longer     duration of time out of work. This community-based participatory research study aims to     deliver and evaluate the impact of a web-based job seeker tailored tobacco cessation     intervention vs. a control group in the San Francisco Bay Area. This research investigates     whether an employment-centered tobacco treatment intervention is efficacious in supporting     abstinence and also associated with more timely engagement of employment.   "
61710|NCT02477852|"     The purpose of this study is to determine the better preoperative anti-tuberculosis treatment     period of patients with spinal tuberculosis.   "
61712|NCT02477826|"     The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or     Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or     overall survival compared with chemotherapy in patients with advanced lung cancer.   "
61646|NCT02478684|"     Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the     placenta through the umbilical cord to the infant, thus resulting in a placental transfusion.     This transfusion may improve circulating volume at birth leading to a smoother postnatal     transition and overall improved outcome for preterm infants. The average blood volume     delivered with DCC up to 90 seconds in preterm infants has been estimated to be about 12 ml     per kg with vaginal deliveries resulting in slightly higher transfusions compared to cesarean     deliveries. Several several short-term benefits have been described including a reduction in     the need for blood transfusions as well as a possible reduction in intraventricular     hemorrhage and necrotizing enterocolitis. All mothers with threatened preterm delivery     between 28 and 34 6/7 weeks will be approached for the study. Following consent, the infant     will be randomly assigned to either a 30 or 60 second delay in cord clamping in the delivery     room. If the infant is not breathing by 30 seconds, the cord will be clamped and the infant     moved to a resuscitation area. The primary outcome is a 3 percent difference in the     hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in     each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean     hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.   "
61647|NCT02478671|"     Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and     pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.   "
61648|NCT02478658|"     Study the circulatory levels of irisin in response to one session of high-intensity     resistance training in a group of healthy subjects.   "
61649|NCT02478645|"     Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery     experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with     HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such     as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is     unknown. The aim of this study is to determine the effective dose of ramosetron for     prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based     patient-controlled analgesia after gynecological laparoscopic surgery.   "
61665|NCT02478437|"     This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the     medial branch nerves of the lumbar facet joint is effective for the treatment of low back     pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that     the brain does not receive the message that the low back is in pain. This technique is     commonly performed by burning these nerves rather freezing them, but it is suspected that     freezing them results in better pain relief. The CRFA blocks has been shown to effectively     treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is     suspected that CRFA will be effective when treating pain related to facet joints in the low     back. We are performing this study in order to determine if that is the case.   "
61650|NCT02478632|"     The purpose of this study is to evaluate any change from baseline in bone mineral density     (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen     containing Tenofovir disoproxil fumarate (TDF) to the nucleoside reverse transcriptase     inhibitor (NRTI) - sparing two - drug regimen of dolutegravir (DTG) + rilpivirine (RPV) in     subjects participating in the parent studies 201636 and 201637 (SWORD-1 and SWORD-2).      This open-label, parallel group, study is a sub-study which will recruit subjects who are     receiving ART regimens which include TDF at the time of randomization to receive treatment in     one of two identical parent studies 201636 and 201637 (SWORD-1 and SWORD-2). These are Phase     III, randomised, open-label, multicentre, parallel-group, non-inferiority studies evaluating     the efficacy, safety, and tolerability of switching to DTG plus RPV from current integrase     inhibitor (INI)-, non NNRTI-, or protease inhibitor (PI)-based antiretroviral regimen in     HIV-1-infected adults who are virologically suppressed, having HIV-1 ribonucleic acid (RNA)     levels <50 copies per millilitre (c/mL). Randomisation in the parent studies will be     stratified by baseline third agent class (INI, NNRTI, or PI), age group (< or =>50 years old)     and participation in this Dual energy X-ray absorptiometry (DEXA) sub-study, therefore there     will also be balance across the treatment arms in this sub-study both overall and with     respect to baseline third agent class and age at entry.      The study population will include approximately 75 evaluable subjects recruited from the     Early Switch DTG + RPV treatment group of the parent studies 201636 and 201637, and     approximately 75 evaluable subjects from the Late Switch group who continue their current     antiretroviral therapy (CAR) through to Week 52 across both the 201636 and 201637 (SWORD-1     and SWORD-2) studies. Subjects participating in study 202094 will have DEXA scans performed     at Day 1 and at study Weeks 48, 100 and 148 in parallel with the corresponding scheduled     visits in the parent studies.   "
61651|NCT02478619|"     The purpose of this study is to assess the effect of preoperative inspiratory muscle training     in patients with grade III obesity undergoing bariatric surgery. It will be a double-blind     randomized controlled clinical trial with volunteers allocated in two groups that will be     compared according to postoperative evolution (pulmonary complications, lung function,     strength and endurance of the respiratory muscles and respiratory system resistance).   "
61652|NCT02478606|"     This study investigates the influence of two different stretching techniques on the     flexibility of the muscles that are in the posterior thigh, after a training period.      The study will last for six weeks where the volunteers need to go to the lab twice for     evaluation, and for four weeks, three times a week for the application of stretching     training.      Evaluation before and after the training period consists of applying hip and knee flexibility     tests, evaluation of strength, muscle activation and muscle architecture. The Flexibility     tests are: (1) Straight Leg Raise Flexibility Test (SLR), where the volunteer will be     positioned supine on a stretcher. Then the appraiser will perform hip flexion keeping the     knee extended and relaxed foot to the angle at which the person refer discomfort while the     contralateral limb remain firmly leaning on the table; (2) Modified Passive knee extension     (TEJ), where the volunteer will be positioned supine on a stretcher. The assessor shall     determine the hip member to be rated at 90º and perform knee extension to the angle at which     the person refer discomfort. The contralateral limb remain firmly leaning on the table.      For the evaluation of muscle strength the volunteer had sat on equipment, makes five     repetitions of bending and straightening the knee to familiarize yourself with the equipment     and after will make other five replicates doing maximum strength.      To evaluate the electrical activity will be the depilation of the skin with a razor and     cleaning with an alcohol swab after adhesive electrodes will be placed for collection of     muscle activity, the electrodes do not emit shocks.      The muscle architecture will be assessed via a ultrasound , to its use the use of a water     soluble gel to improve the machine's skin contact is required.      For the intervention, the stretching will be held in both legs, where the volunteer will     remain lying on a stretcher with fixed trunk with velcro straps and the researcher will carry     out the elongation raising the leg drawn to the moment of discomfort the volunteer will refer     and will remain for 30 seconds (s) in case he belongs to passive static stretching group, if     the stretching group of proprioceptive neuromuscular facilitation, will be in the same     position, but before the 30s of stretching, he you will have to push against during 6s to     lower leg against the researcher.      If he belongs to the control group, have only two trips to the laboratory for testing, will     make an initial assessment and after four weeks will return to perform the tests again, in     the period between assessments will not need to go to the lab because it does not make     intervention elongation.      It is possible that there discomfort during flexibility testing, strength testing and     stretching training. After the tests can still experience muscle pain should disappear within     48 hours. The risks of research are minimal, not exceeding those of a strength training     session and stretching.   "
61653|NCT02478593|"     The overall goal of this research is to develop and test strategies to decrease potentially     inappropriate medication use among the elderly.   "
62405|NCT02468778|"     The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for     use during high risk percutaneous coronary interventions (PCI) performed in elective or     urgent, hemodynamically stable patients with severe coronary artery disease and depressed     left ventricular ejection fraction.   "
61654|NCT02478580|"     Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative     morbidity and mortality. This group of patients is at risk of perioperative desaturations     which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA     patients might also need to spend the night in intensive care for more frequent monitoring     for any desaturations episodes especially if the patient will be requiring multiple     intravenous narcotic boluses for pain control. Several studies have looked into the most     appropriate way to manage these patients and some recommendations have been made to avoid     outpatient surgery with close monitoring for first 24 hours after surgery specifically if     patient will require intravenous postoperative narcotics.      Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA     approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and     obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or     modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown.      Nuvigil is longer acting product which is similar in action to Modafinil however is much     cheaper. Nuvigil has not been previously studied for postoperative recovery. The     investigators intend to study the effects of Nuvigil on postoperative recovery time and     wakefulness in obstructive sleep apnea and obese patients.   "
61655|NCT02478567|"     Randomized crossover trial evaluating the impact of exercise training sequence of     axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement     syndrome.   "
61656|NCT02478554|"     Fetal growth abnormalities is one of the most common problems faced in modern obstetrics. The     association between low birth weight and perinatal death as well as severe morbidity is well     known. Since fetal weight cannot be measured directly, obstetricians use estimates of fetal     weight obtained by utilizing various ultrasonographic measurements to diagnose growth     abnormalities. Currently in clinical practice, the majority of fetal ultrasound centers     employ population-based fetal growth curves that have been previously published and updated     to estimate fetal weight percentiles. Up to 70% of neonates found to be below the 10%     percentile for estimated fetal weight in population-based growth curves are actually     constitutionally small; that is a neonate deemed small based on standardized growth curves     but in reality have reached its appropriate growth potential in relation to its genetic     predisposition.      An equally difficult clinical scenario is fetal macrosomia. A recent meta-analysis revealed     that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from     15-79%. When compared with neonates with normal birth weight, the odds ratio of emergency     cesarean delivery and shoulder dystocia are increased significantly.      Various ultrasound parameters have been tested in an effort to detect both fetal compromise     prior to the development of permanent damage and allow differentiation between true fetal     growth abnormalities and normal growth potential. Recent reports have introduced the concept     of customized fetal growth curve which uses physiological variables to report an adjusted     fetal growth assessment. To date, the use of customized fetal growth curves has not been     evaluated prospectively. Furthermore, this strategy has not been compared to standard     population-based fetal growth curves currently used in clinical practice to determine which     would be the most ideal for use in clinical practice.      The primary research question is: are customized fetal growth curves more accurate than     population-based fetal growth curves at predicting abnormalities in fetal growth, defined as     small-for-gestational age or large-for-gestational age at birth in newborns of high-risk     pregnancies? Randomly, participants will be assigned to either having fetal growth reported     by customized or population bases growth curves.   "
61691|NCT02478099|"     To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET and 18F-FB-IL2-PET -     as complementary tools for selection of patients to be treated with MPDL3280A, within this     treatment trial the investigators will assess safety, tolerability and anti-tumor activity of     MPDL3280A in cancer patients, who have undergone investigational imaging.   "
61657|NCT02478541|"     High levels of fatty substances in the blood increase the risk of developing coronary heart     disease and having a heart attack. The investigators know a lot about one of these fatty     substances, cholesterol. However, there is another fatty substance in the blood called     triglyceride. The investigators do not understand much about what regulates the rate at which     the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s).     The investigators are developing new techniques to measure these processes in healthy people.     Ultimately a deeper understanding of the regulation of this process might lead to the     development of new treatments for fat accumulation in the liver and high blood fat levels and     related disorders. The present study is an investigation of how these processes relate to     various bodily characteristics such as thinness and fatness and the distribution of fat in     the body.   "
61658|NCT02478528|"     Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact     at the individual level but also social and economic level (loss of productivity, morbidity,     mortality) emphasize the need for one hand, to improve the investigators' understanding of     these disorders in order to develop appropriate therapeutic tools and on the other hand, to     increase the investigators' support abilities of patients with these disorders.      The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration     with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and     tools to compensate the investigators' sleep debt in order to apply them to patients with     sleep disorders and persons who face with sleep restriction.   "
61659|NCT02478515|"     Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular     edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is     expected that similar results could be obtained by less frequent IVR. The purpose of this     study is to investigate if IVR by PRN is as effective as by monthly. In addition, the     investigators are going to study the relationship between macular edema and the size and     location of retinal non-perfusion area.   "
61660|NCT02478502|"     Germ cell tumors belong to the most chemosensitive malignancies. Paclitaxel in combination     with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ     cell cancer.      Cabazitaxel may overcome resistance to docetaxel and paclitaxel and might have clinical     activity in patients with metastatic and progressive germ cell tumors.   "
61661|NCT02478489|"     The specific aims of this pragmatic randomized controlled trial are to compare initiating     injectable extended release naltrexone (XR-NTX) or oral naltrexone (PO-NTX) at the time of     discharge from a medical hospitalization for patients with alcohol use disorder (AUD) on: 1)     alcohol consumption and consequences, and 2) acute healthcare utilization (including hospital     readmission and emergency visits) and cost-effectiveness. In exploratory analyses, the     investigators will assess moderators of medication effects including demographic, behavioral,     and genetic factors.   "
62231|NCT02471040|"     This study is designed to examine the value of infusing BHB in type 1 diabetic subjects     during experimentally induced hypoglycemic episode in conjunction with testing of cognitive     function. This will lay the basis for subsequent trials exploring the novel use of     therapeutic doses of oral ketone formulations that are currently under commercial     development, which could serve as adjunct therapies to protect the brain from hypoglycemia in     type 1 diabetic subjects experiencing recurrent hypoglycemia.   "
61662|NCT02478476|"     The presence of single nucleotide polymorphisms (SNPs) in genes involved in platinum and     taxane metabolism and detoxification have been correlated to increased risk of severe adverse     events (AEs) when patients receive these drugs. The investigators propose studies to validate     a comprehensive panel of twelve SNPs in ovarian cancer patients that may predict AEs when     treated with therapies that include platinum and taxanes. Using these results to stratify     patients to different dosing regimens, routes of administration, or in recurrent cancer to     aid in drug selection, may improve outcome and reduce costs for the management of drug     related side effects while not changing standard of care. Since these differences can be     detected from blood, the determination of genotypes can be done using a standard blood sample     taken after ovarian cancer is confirmed on the patient's pathology report. These genetic     differences can be detected by QPCR and Next Generation Sequencing.   "
61663|NCT02478463|"     Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus     (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and     infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical     sites associated with sexual HIV transmission following the proposed 600 milligram (mg)     intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB     distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1     transmission and supplement the data to support future PrEP clinical trial development. The     primary objective is to determine the PK concentrations of CAB following LA administration in     plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in     healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women     following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy     subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations     associated with sexual HIV-1 transmission: vaginal tissue, cervical tissue, cervicovaginal     fluid, rectal tissue, and rectal fluid. The study will consist of a screening period, a     28-day oral lead-in phase at a dose of 30 mg per day followed by a 14-21 day washout period,     and a single dose of CAB LA 600 mg as an IM (intragluteal) injection with compartmental     pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will return for safety assessments     and plasma PK sampling at Week 24 and Week 36 post-injection and undergo a     follow-up/withdrawal visit at Week 52 post-injection   "
61664|NCT02478450|"     This study is a non-randomized, open-label, partially blinded, sequential cohort,     dose-escalation study designed to obtain preliminary data on the safety, tolerability, and     early efficacy of Q-Cells® transplantation in subjects with ALS. Following an initial cohort     receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will     receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and     outcome measure assessors will be blinded to side of treatment. The study will be conducted     at sites with extensive clinical experience with the care of patients with ALS.   "
61707|NCT02477891|"     The objective of this study is to provide early access to daratumumab treatment and collect     additional safety data while the medication is not commercially available or available     through another protocol for subjects with multiple myeloma who have received at least 3     prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent     (IMiD) or whose disease is double refractory to both a PI and an IMiD.   "
62934|NCT02461888|"     This study evaluates a new treatment combination of ixazomib with cyclophosphamide and     dexamethasone in relapsed or refractory multiple myeloma. Participants will either receive     ixazomib with cyclophosphamide and dexamethasone or cyclophosphamide and dexamethasone alone.   "
61666|NCT02478424|"     Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent     anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study     (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell     transplantation were given CBD 300 mg/day starting 7 days before transplantation until day     30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of     methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients     developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the     cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and     5%, respectively. Compared to 101 historical control subjects given standard GVHD     prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with     CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100     days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were     20% and 33%, respectively.      The aim of this study is to explore the safety and efficacy of extended use of CBD until day     100 in the prevention of acute and chronic GVHD.   "
61667|NCT02478411|"     Study designed to evaluate the functional and motor effects in critically ill subjects at ICU     and hospital discharge with the incorporation of a mobilization program of cycloergometric     physiotherapy sessions compared with conventional physiotherapy.   "
61669|NCT02478385|"     The main purpose of this study is to explore the impact of the birth environment on women's     birth experience and relevant birth outcomes in the experimental Labour room compared to a     standard Labour room.   "
61670|NCT02478372|"     The purpose of this study was to determine if the method of peri-operative analgesia used     following total Knee Replacement surgery affected the progress towards rehabilitation goals     and to determine whether the analgesia had any impact on long term outcomes.   "
61714|NCT02477800|"     The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab     in slowing cognitive and functional impairment as measured by changes in the Clinical     Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with     early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as     compared with placebo on clinical progression as measured by Mini-Mental State Examination     (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative     Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)     [ADCS-ADL-MCI].   "
62232|NCT02471027|"     This study is a registration study.The main research: the curative effect of neoadjuvant     chemotherapy in the treatment of ⅠB2 and ⅡA2 locally advanced cervical cancer.Research group:     the neoadjuvant chemotherapy in combination with cervical cancer radical hysterectomy.Control     group:cervical cancer radical hysterectomy directly.Main observation indexes is overall     survival and disease-free survival.   "
61671|NCT02478359|"     Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the     US. The personal, social and economic costs of the disease are tremendous, with annual     expenditures of nearly $50 billion, mostly from hospitalizations for exacerbations of COPD     and associated sequelae. For the vast majority of patients, despite optimal pharmacological     therapy, living with COPD is characterized by unrelieved dyspnea, physical inactivity,     deconditioning, and an insidious downward spiral of social isolation and depression that has     a profound impact on the lives of patients and their caregivers. There is mounting evidence     that physical inactivity is significantly associated with more frequent hospitalizations and     increased mortality in COPD even after adjusting for disease severity.      While practice guidelines recommend regular physical activity for all patients with COPD,     health systems are challenged in operationalizing an effective and sustainable approach to     assist patients in being physically active. The investigators propose a pragmatic randomized     controlled trial to determine the effectiveness of a 12-month physical activity coaching     intervention (Walk On!) compared to standard care for 1,650 COPD patients from a large     integrated health care system.   "
61672|NCT02478346|"     This study focuses on implementing Yellow 560 for the direct intraoperative visualization of     Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop     better treatment protocols, and improve the prognosis of a wide array of neurosurgical     diseases. More specifically, for the patients who are undergoing surgical intervention for     the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the     investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or     in general residual lesion which must be corrected.   "
61673|NCT02478333|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy     Japanese adult participants.   "
61674|NCT02478320|"     The goal of this clinical research study is to learn if ilorasertib (ABT-348) can help to     control CDKN2A-deficient cancer. CDKN2A deficiency is a type of mutation (a genetic change).     The safety of this drug will also be studied.   "
61675|NCT02478307|"     Up to 80% of Australians experience back pain and 10% have significant disability as a     result. There is a critical need for the development and evaluation of innovative treatments     that have the capacity to target the multidimensional nature of chronic low back pain. This     study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy,     and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately     lead to streamlined interventions designed to efficiently maximise benefit.   "
61676|NCT02478294|"     This cohort study aims to evaluate thoracoscopic left atrial appendage excision plus atrial     fibrillation ablation versus oral anticoagulants for the prevention of stroke and non-central     nervous systemic embolism in patients with atrial fibrillation and thromboembolism.   "
61677|NCT02478281|"     A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of     Methylene Blue Injection, USP 1 mg/kg in healthy adult voluneetrs.   "
61690|NCT02478112|"     The benefit of dose escalation in radiotherapy (RT) for biochemical control of prostate     cancer is a clearly established fact based on the results of different published prospective     trials. This benefit, acquired with three-dimensional conformal radiation technique is     counterbalanced by an increase in urinary and gastrointestinal toxicity. The joint progress     of dose planning systems and multileaf collimators (MLC) technology have enabled the     Intensity Modulated Radiation Therapy (IMRT). Recently the contribution of spacers     positioned in the septum between the rectum and the prostate could improve the functional     results of IMRT in terms of rectal toxicity.      The aim of the investigators study is to assess the dosimetric gain from the contribution of     the implantable BioProtect balloon on organs at risk.   "
63120|NCT02459457|"     The purpose of this study is to determined the best scheme in paclitaxel and     cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy     for patients with local advanced esophageal Squamous Cell Carcinoma.   "
61678|NCT02478268|"     The purpose of this study is to determine whether magnetic resonance imaging (MRI) using     inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung     function and detect changes over time in patients receiving treatment as well as those who     don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show     areas of abnormal thickening of parts of the lungs. These images combined with images taken     with injected contrast agents or other types of MRI may provide a better way to look at lung     structure and function in patients with IPF. The ultimate goal is to predict how a particular     patient might respond to a particular therapy and to observe such responses earlier than     conventional tests. The investigators anticipate that the images acquired in this study will     provide more specific information about lung disease than standard lung function tests. The     use of 129Xe MRI is investigational. Investigational means that these tests have not yet     been approved by the US Food and Drug Administration and are being tested in research studies     like this one. In addition, standard MRI with contrast is not typically done as standard of     care for monitoring progression of IPF, therefore, its use in this study is also considered     investigational.      Healthy volunteers are being asked to participate in this study because the investigators     need to develop a database of functional images that are representative of healthy lungs.   "
61715|NCT02477787|"     This is a single center, open label, random comparison phase 2b study. The primary objective     of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic,     donor-derived natural killer (NK) cells infused after HLA-haploidentical hematopoietic cell     transplantation (HCT) in patients with refractory acute myelogenous leukemia (AML).      The secondary objectives of the study are to assess the side effects of donor NK cell     infusion, effects of donor NK cell infusion upon HCT outcomes, as well as effects upon     post-HCT immune recovery.   "
61771|NCT02477059|"     Hand osteoarthritis (HOA) which affects the interphalangeal joints and the     metacarpophalangeal of the thumb is a common disease, the prevalence of which being about 30     % of the population over than 70. Some forms of HOA are refractory to usual treatments     (analgesics, NSAIDs, local injections) and can lead to a high disability. In vitro and in     vivo studies showed that IL-6 is involved in the OA process. The aim of the present study is     to assess the efficacy of an Interleukin-6-Receptor Inhibitor (tocilizumab) on pain and     function in patients with refractory hand OA.   "
61679|NCT02478255|"     The purpose of this study is to determine whether magnetic resonance imaging (MRI) using     inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize     impaired lung function and detect changes over time in patients receiving treatment as well     as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be     able to show areas of abnormal thickening of parts of the lungs. These images combined with     images taken with injected contrast agents or other special types of MRI such as conventional     proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate     goal is to predict the degree of radiation-induced lung injury that will develop in a given     patient for a given treatment plan. The investigators anticipate that these images will     provide more specific information about lung disease than standard lung function tests. The     use of 129Xe MRI is investigational. Investigational means that these tests have not yet been     approved by the US Food and Drug Administration and are only available in research studies     like this one. In addition, standard MRI with contrast is not typically done as standard of     care for monitoring changes due to thoracic radiation therapy, therefore, its use in this     study is also considered investigational.      Healthy volunteers are being asked to participate in this study because to develop a database     of functional images that are representative of healthy lungs.   "
61680|NCT02478242|"     Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during     continuous renal replacement therapy in acute kidney injury patients at a high risk of     bleeding.   "
61681|NCT02478229|"     The study is a single centre, single arm, open-label, proof of concept study enrolling 20     adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will     receive Sofosbuvir (SOF) and Ledipasvir (LDV) starting at time of liver transplantation (OLT)     and continues for 12 weeks. Subjects will be receive 24 week post-treatment follow up.   "
61682|NCT02478216|"     The patients were allocated randomly to receive remote preconditioning group (RIPC group, R)     or not (Control group, C) using sealed envelopes with the options inside the sealed envelope     of R and C before anaesthesia induction. The registered nurse who did not participate in     patient care and was blind to the study performed the all randomization process. All medical     staffs who involved the patient care were blind to the study. All data were collected by     trained observers who were blind to the study and did not participate in patient care   "
61683|NCT02478203|"     After Local Human Research Ethics Committee approval, emergency medical staff enrolled in     this study. After watching a video about the intubation using Airtraq, Glidescope or direct     laryngoscopy, they attempted to intubate a pediatric manikin in three different airway     models.   "
61684|NCT02478190|"     Emergency Department (ED) patients with severe hyperglycemia will be randomized to two     treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL.      Randomization is stratified by whether the chief complaint is High Blood Sugar in the     electronic medical record or other.   "
61685|NCT02478177|"     The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is     designed to provide important and timely insight into the management of acute stroke patients     who are on novel oral anticoagulants in community practice.   "
61686|NCT02478164|"     This research study is studying a chemotherapy as a possible treatment for recurrent     glioblastoma that has not responded to bevacizumab. The name of the study drug involved in     this study is Ponatinib.   "
61687|NCT02478151|"     This trial will examine the safety and feasibility of using the OrganOx Metra device to     transport and store donor livers under normothermic conditions prior to transplantation.     Participants will be followed for 3 months following transplantation and their outcomes     recorded.   "
61688|NCT02478138|"     Cervical lymph node involvement, in head and cancer neck patients, is one of the most     important prognostic factors. Currently patients undergo neck dissection removing some or all     nodes and neck involvement is retrospectively determined. Sentinel lymph node (SLN)     identification and biopsy has become clinical practise in other areas including breast, skin,     and gastric cancer. The gold standard for detecting metastatic lymph nodes is pathological     analysis, but the lack of an accurate or clinically accepted way to identify sentinel lymph     nodes in the cervical region has motivated the usage of indocyanine green (ICG) and     near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo). A prospective     clinical trial using a commercially available NIR system and ICG injection around the tumour     site will evaluate the ability to detect and biopsy sentinel lymph nodes in head and neck     cancer patients.   "
61689|NCT02478125|"     Hypothesis: Treatment with Burixafor hydrobromide will effectively mobilize metastatic     prostate cancer (PCa) cells (i.e. disseminated tumor cells; DTCs) into the blood from the     bone marrow. It has been demonstrated that prostate cancer cells have been mobilized out of     the bone marrow of mice utilizing an anti-CXCR4 strategy; making them more susceptible to     chemotherapy.   "
62935|NCT02461875|"     The aim of study is to compare the efficacy of GnRH antagonist rescue combined with     cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high     risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.   "
61713|NCT02477813|"     It is a single-arm, open label clinical trial. Patients affected by relapsed or refractory     small-cell lung cancer patients with MGMT promoter methylation are included in this study;     they will be treated with oral Temozolomide 200 mg/m2 die for 5 consecutive days every 28     days. Treatment will be continued until tumor progression, intolerable toxicity or patient     refusal.      A Minimax Simon 2-stage design will be used. - First stage: 9 patients If 1 or less responses     will be observed, the trial will be ended.- Second stage: other 10 patients (for a total of     19 subjects enrolled) If 5 or less responses will be observed in 19 patients, the treatment     will not be considered active, while if 6 or more responses will be observed, the treatment     will be considered sufficiently active to warrant further testing. Since the rate of     methylation ranges from 20 to 48% the number of patients to be screened should be between 40     and 95.      The primary objective is to determine the overall response rate [ORR = CR + PR]; the     secondary objectives are to determine the time to Progression (TTP), the overall Survival     (OS), the toxicity and the correlation between response Rate (RR) and the level of MGMT     promoter methylation and/or base excision repair (BER) genes alterations.   "
62433|NCT02468414|"     The objectives of this study are to assess safety and to evaluate the biologic activity of     TARGTEPO treatment in Peritoneal Dialysis patients   "
61692|NCT02478086|"     Introduction:      The preterm newborn of extremely low birth weight (PNELW), endures adverse nutritional     conditions to mimic intrauterine growth. It´s known that amino acids contribute to protein     synthesis, but also intervene in weight gain. Most newborns receive amino acids throw     parenteral nutrition at a doses of 3.5gr/k/day, that doses its unable to reach the birth     weight when discharged, so the weight its below the 10th percentile, which rises the risk for     presenting alterations in neurodevelopment.      Objective:      To compare a higher doses of parenteral amino acids vs. standard doses, expecting an     increased weight gain in the high amino acid doses group, meanwhile following the renal     function security profile      Methods:      A randomize, single blind clinical trial, carried on, in the Neonatology Service of Unidad     Medica de Alta Especialidad Numero 48 of the Instituto Mexicano del Seguro Social, in the     city of Leon, Mexico. Between the period of 1st August 2012 to 31 January 2013. A standard     doses of amino acids was administered (3.5gr) to a control group and a high doses (4gr) to an     experimental group. Weight, urea, creatinine and blood urea nitrogen (BUN) were measured     weekly. In the study were included all preterm newborns (PN) weighting less than 1500 grs and     with less than 32 weeks of gestational age that match all the inclusion criteria. Statics     Analysis: descriptive statistics were calculates, also chi2 test and Fisher Exact test were     applied to categorical variables, t-student test to continuous variables, and ANOVA in     multiple groups.   "
61693|NCT02478073|"     Antibiotic dosing in critically ill patients poses a challenge for clinicians due to the     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.      Patients in the Intensive Care Unit (ICU), treated with piperacillin/tazobactam, had their     plasma concentration of piperacillin determined 1-3 times weekly. Patients received     piperacillin as intermittent bolus infusion 3 times daily or as continuous infusion (this was     up to the treating physician). Time above the minimal inhibitory concentration (T>MIC)     estimated for each patient was evaluated against clinical breakpoint MIC for Pseudomonas     aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f     T>MIC (free piperacillin concentration maintained above the MIC throughout the dosing     interval) and 50% fT>4xMIC (free piperacillin concentration maintained at a level fourfold     the MIC for at least 50% of the dosing interval).   "
61694|NCT02478060|"     The purpose of this study is to evaluate the safety and tolerability of multiple     administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic     parameters and clinical outcomes.   "
61695|NCT02478047|"     The purpose of this study is to clarify whether distal-proximal point association is more     effective than partial match point association by electro-acupuncture in the management of     chemotherapy-induced nausea and vomiting .   "
61696|NCT02478034|"     In this study the effects of mineralocorticoid stimulation on social cognition will be     investigated in healthy young individuals.   "
61697|NCT02478021|"     The effects of hydrocortisone on cognition will be investigated.   "
61698|NCT02478008|"     The purpose of the study is to evaluate the initial short and long-term safety and     performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the     Transapical Delivery System.      The study will enroll patients with moderate to severe mitral valve regurgitation who are     considered high or extreme risk for mortality and morbidity from conventional open heart     surgery.   "
61699|NCT02477995|"     Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using     of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced     incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may     cause more side reactions after vaccination. Since 2000, the basic immunization DTwP vaccine     has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.     In 1995, DTaP was successfully developed in China, and have been used in EPI at present.     Because of effective immunity and little side reaction, DTaP has been widely recognized and     accepted by the parents.   "
61700|NCT02477982|"     The primary objective of this study is to develop a descriptive and predictive     pharmacokinetics model propofol disposition during cardiopulmonary bypass (CPB) in obese and     lean patients.   "
61701|NCT02477969|"     This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study     that will enroll approximately 564 T2DM patients who before screening have inadequately     controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8 weeks of     metformin monotherapy at stable doses（≥1500 mg/day).   "
61702|NCT02477956|"     Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12,     Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is     giving to patients with their routine supplements and followed up for 6 months.      Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in     addition to the standard vitamin D protocol will have a significant rise in serum vitamin D     levels compared to the subjects taking only the usual vitamin D protocol.   "
61703|NCT02477943|"     This study is designed to collect data which will be used to correlate changes in EEG to mild     TBI in sports concussion.   "
61704|NCT02477930|"     The purpose of this registry is to collect data on the clinical use of endoluminal vacuum     (E-Vac) therapy to treat both upper and lower intestinal leaks and perforations.   "
61705|NCT02477917|"     The study was designed according to the draft of allergenic product regulation published by     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of     subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with     rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy     parameters will be evaluated: immunoglobulin level changes and skin reactivity.   "
61706|NCT02477904|"     This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,     and moderate protein) in treating autism spectrum disorder (ASD). Three study groups will be     comprised of children (2-21 years of age) based on whether or not they have ASD and receive     the ketogenic diet - ASD/ketogenic diet, ASD/non-ketogenic diet, and non-ASD/non-ketogenic     diet.   "
62263|NCT02470624|"     This is a multi-center registry study. The investigators will include 10,000 patients with     confirmed acute ischemic stroke in China. The aim of the study is to survey current treatment     situation in China and compare the effectiveness and safety between different intervention     regimens.   "
61716|NCT02477774|"     This is a single-blinded multi-institutional randomized controlled trial to evaluate the     effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol,     Warwick, RI) in reducing drainage output in anterolateral thigh (ALT) free flap donor sites.     Increased drainage from donor sites can lead to seroma formation with possible secondary     infection, delayed hospital discharge, and additional home care needs for drain care. Arista     is an inert plant based absorbable surgical hemostatic powder that can be easily applied to     broad surgical fields to reduce bleeding and seroma rates. Therefore, its application to free     flap donor sites may bear significant potential benefit.      Specific Aim 1: The main hypothesis of the study is that the use of Arista in anterolateral     thigh (ALT) free flap donor sites prior to closure will reduce postoperative drain outputs     and time to drain removal compared to ALT donor sites closed without Arista.      Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will     reduce postoperative ALT donor site seromas and patient hospital length of stay.   "
61717|NCT02477761|"     The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on     plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent     insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a     75 g glucose ingestion in diet-controlled type 2 diabetic patients.   "
61718|NCT02477748|"     This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of     MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.      The study will be comprised of Screening, Washout (if required), Treatment (total of 10     weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial     eligibility assessments.   "
61719|NCT02477735|"     The purpose of this study is to investigate the prevalence of sleep disturbances in children     with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion     (TTI) on sleep disturbances.   "
61760|NCT02477202|"     Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk     of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a     large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae     (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular     method of contraception, but it is not known if its use will reduce a woman's risk of IEOC.     Mirena® use does not block ovulation in most women but it may release sufficient progestin to     also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the     Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against     IEOC.   "
61720|NCT02477722|"     Exposure to life threatening, traumatic and stress inducing events in general is an     inevitable part of military combat service . Among individuals exposed to a traumatic event,     approximately 85-90 % will develop a stress response from which they will recover without     need for any medical intervention whatsoever. However, roughly 10-15 % will continue to     suffer from post-traumatic symptoms along with depression or anxiety disorders1, . The     prominent symptoms of post - traumatic stress disorder (PTSD), consists of reliving the event     via invasive and painful memories that include: images, thoughts or feelings, night terrors,     and extreme emotional distress that arise when exposure to external or internal cues similar     to or symbolizing aspects of the traumatic event. Following this distress, behavioral     avoidance of situations that trigger unpleasant memories may develop. Such mental stress may     lead to avoidance of social situations and hinder normal daily functioning in a variety of     contexts2. The question arises as to what distinguishes between those who are exposed to a     traumatic event and recover spontaneously and those who fail to resume daily life and develop     PTSD. Attempts to find personality and environmental risk factors for the development of PTSD     have yet to yield any unequivocal conclusions. This has lead the scientific community to look     for neuro-physical risk factors as well . Furthermore, evidence that early diagnosis and     treatment of the disorder helps reduce the severity of post-trauma symptoms -stresses the     need for the accurate localization of neurological risk factors and new immediate and/or     preventative interventions. The aim of the present project is to develop a brain oriented     training method for early preventive interventions of PTSD.   "
61721|NCT02477709|"     This study assesses the tolerability of a single dose of gefapixant (AF-219) in participants     with idiopathic pulmonary fibrosis (IPF). Six eligible participants will receive a single 150     mg dose of gefapixant and undergo tolerability and PK assessments.   "
61722|NCT02477696|"     This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously     treated chronic lymphocytic leukemia.   "
61723|NCT02477683|"     The purpose of this study is to collect data to support decisions made by BioFire regarding     assay development, panel composition, and intended use for the final FilmArray FI reagent     pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients     under 3 years of age that present with acute fever.   "
61724|NCT02477670|"     The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability     of AVP-786 as an adjunctive treatment compared with placebo in patients with residual     schizophrenia.   "
61725|NCT02477657|"     Malignant ascites leads to significant morbidity in patients with terminal cancer.     Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of     relief after paracentesis are detrimental to quality of life(QOL). Two devices are available     as alternatives to paracentesis. The impact of either device on QOL has not fully been     explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom     relief using validated survey instruments is proposed.   "
61726|NCT02477644|"     Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced     FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal     Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and     Bevacizumab Concurrent with Chemotherapy and in Maintenance.   "
61770|NCT02477072|"     Hypothesis: Optimal anticoagulation defined as an Activated Clotting Time (ACT) of 300 to 350     seconds obtained by weight-adjusted doses of unfractionated heparin (UFH) will improve the     hemostatic environment downstream from the vascular clamp, provide better blood flow in the     distal bed following peripheral revascularization surgery.      Objectives: This study is designed to assess the effects of an optimized regimen of UFH on     the hemostatic environment downstream from the vascular clamp in major vascular surgery.   "
61727|NCT02477631|"     The effect oral iron chelator Deferiprone on the Oxidative stress and on Iron Overload status     in transfusion dependent, iron-overloaded low risk MDS patients;      Primary Objective:      • To evaluate the effect of Deferiprone on oxidative stress parameter - Reactive oxygen     species (ROS).      Secondary Objectives:        -  To evaluate the effect of Deferiprone on other oxidative stress parameters             1. Reduced glutathione             2. Membrane lipid peroxidation             3. External phosphatidylserine        -  To evaluate the change from baseline to last visit in parameters of iron load.             1. Serum ferritin (despite ongoing RBC transfusions during the study period).             2. LIP             3. LPI             4. serum hepcidin        -  To evaluate the change from one month preceding baseline visit to last month on study in          transfusion requirements.        -  To monitor safety measures:             1. Adverse events (AEs).             2. Number of discontinuations due to AEs      Study design:      Single-arm, open-label, multi-center study in 20 iron-overloaded patients with low risk MDS.     All participants will be treated with deferiprone for up to 4 months. Patients will have     complete blood count monitored weekly, and will visit the site monthly for assessments of     safety and efficacy.   "
61728|NCT02477618|"     This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the     efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects     in Super-Refractory Status Epilepticus (SRSE).   "
61729|NCT02477605|"     The purpose of this study is to compare the treatment day change between immediate     postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and     23-gauge vitrectomy instruments.   "
61730|NCT02477592|"     The purpose of this study is to compare effectiveness of two substrate modification     approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a     substrate-based, individualized substrate modification (ISM)approach should be superior to     traditional stepwise ablation(SA). To the best of investigator's knowledge, this was the     first study to evaluate the real substrate by means of electro-anatomic mapping and to     perform true substrate modification in long standing persistent atrial fibrillation     ablation(LPAF).   "
61731|NCT02477579|"     This study evaluates the safety and effectiveness of the a novel device called NovaCross to     help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.   "
61732|NCT02477566|"     To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical     pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in     infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro     fertilization (IVF) or Intracytoplasmic sperm injection   "
61761|NCT02477189|"     This is a retrospective evaluation of all subjects who successfully received implantation of     the Silicone Block for correction of soft tissue deformities of the penis. In addition,     subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing     satisfaction with the implant and any adverse events that may not have been reported to the     physician.   "
61733|NCT02477553|"     Experts believe that increasing the low uptake of screening for colorectal cancer (CRC)     requires educating patients about all approved tests and helping them choose one that fits     their preferences. As one motto puts it: The best test is the one that gets done. Screening     tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less     invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how     best to educate patients about the options and the tradeoffs involved. Some guidelines     recommend that decision aids, a promising tool in this area, provide patients with detailed     quantitative information, including baseline risk, risk reduction, and chance of negative     outcomes. But this sort of comparative effectiveness data can confuse patients, especially     those with limited mathematical ability. Previous studies have not measured the effect of     providing quantitative information to patients with varying levels of ability or interest or     asked them whether such data is essential for their decision-making.      The investigators will conduct a clinical trial to determine the impact on patients who view     a decision aid (DA) that includes quantitative information versus a DA without such data. The     investigators will also seek to determine whether numeracy moderates the effect of     quantitative information.   "
61734|NCT02477540|"     This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in     critical limb ischemia.   "
61735|NCT02477527|"     Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep     disturbances.   "
61736|NCT02477514|"     The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the     single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.   "
61737|NCT02477501|"     The purpose of the study is to determine if norepinephrine is more effective as a continuous     intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid     loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery.     Prevention of low blood pressure has been shown to decrease nausea and vomiting during and     after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all     participants will receive spinal anesthesia with a local anesthetic and morphine. This study     plans to enroll 120 pregnant women. Patients will be randomly assigned according to a     computer generated system to be in one of two groups.   "
61738|NCT02477488|"     Gout has a strong association with the metabolic syndrome, and it is often seen in patients     with renal insufficiency. Allopurinol is a medication intended to lower uric acid and     therefore prevents gout attacks. Its metabolism is mainly renal, and some evidence shows that     it is also dialyzable. The hypothesis is that allopurinol would be more efficacious to lower     uric acid if it was given after dialysis only. The investigators will then switch     administration of allopurinol to bedtime for dialysis patients currently taking that     medication.   "
61739|NCT02477475|"     The objective of this investigation is to collect following data in patients given NEXIUM     capsule (NEXIUM) in usual post-marketing use.   "
62252|NCT02470767|"     describe the sociodemographic and clinical characteristics of patients diagnosed with     non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on     anticoagulant therapy who have changed their therapeutic regimen, due to any clinical     situation, based on the doctor's routine clinical practice and are currently on treatment     with a direct oral anticoagulant (DOAC)   "
61740|NCT02477462|"     Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial     cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance, high     titers of serum anti-mitochondrial autoantibodies (AMA) directed against the pyruvate     dehydrogenase complex E2 subunit and evidence from both human and murine models suggests that     T-cells, particularly cluster of differentiation (CD) 8+ T cells, are key to the destruction     of bile ducts. However, clinical trials of classic immunosuppressive drugs including     corticosteroids, azathioprine, methotrexate, and tacrolimus have been largely unsuccessful in     altering the disease course. This is a single center, prospective, non-treatment study of the     role of immune responses in PBC patients.      Non-alcoholic fatty liver disease (NAFLD) and its more severe form, non-alcoholic     steatohepatitis (NASH) are common, often silent liver diseases. NASH resembles alcoholic     liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH     is fat in the liver, along with inflammation and fibrosis. NASH can be severe and can lead to     cirrhosis and hepatocellular carcinoma. Ten to 20 percent of American have NAFLD with NASH     affecting 2 to 5 percent of Americans.   "
61741|NCT02477449|"     Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.   "
61742|NCT02477436|"     This is an exploratory clinical study to presume the optimum usage and dosage for a     therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg,     200mg or placebo administered orally in patients with erectile dysfunction. In conclusions,     Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or     200mg 30 minutes before sexual intercourse for 8 weeks.   "
61743|NCT02477423|"     The purpose of this study is to determine whether antibiotics given immediately after birth     alter the development of the developing preterm infant's microbiome, which may further alter     overall clinical outcomes.   "
61744|NCT02477410|"     The purpose of the study is to obtain a better understanding of how hydrolysed porcine     proteins affect the human metabolism, including the effects on muscle protein synthesis,     appetite and secretion of gastrointestinal hormones.      It is hypothesised that hydrolysed porcine proteins will stimulate muscle protein synthesis,     affect appetite and the secretion of gastrointestinal hormones similar to hydrolysed whey     protein.   "
61745|NCT02477397|"     Study to investigate the effects of symptom-driven maintenance and reliever therapy in COPD.   "
61746|NCT02477384|"     The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm     expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus     propranolol for the prevention of recurrent esophageal variceal bleeding.   "
61747|NCT02477371|"     The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study     is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary     artery bypass grafting (CABG) with respect to planning and guiding the revascularization     strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in     patients planned for surgical revascularization.   "
61762|NCT02477176|"     The purpose of this 12-month, prospective, multicenter study is to investigate the effect of     annular defect size and other risk factors on reherniation and associated costs in primary     lumbar discectomy patients.   "
61763|NCT02477163|"     The purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment     in the patients of various types of chronic kidney disease.   "
61748|NCT02477358|"     In cases of permanent tooth avulsion, it is widely accepted that some necrosis always occurs     after avulsion injury. If the pulp tissue does not revascularize or if endodontic therapy is     not performed, the pulp space can become infected. Platelet rich fibrin (PRF) is a second     generation platelet concentrate that allows the clinician to obtain fibrin membranes enriched     with platelets and growth factors from an anticoagulant-free blood harvest. Clinical     relevance of PRF and revascularization has been demonstrated in several case studies of     avulsion. To date no human clinical trials have been performed evaluating the effectiveness     of PRF on pulpal revascularization after reimplantation and its benefits in limiting     inflammation. The following study consists of two phases: Phase 1: An in vitro model     evaluating the effects of PRF in limiting inflammatory response of pdl cell cultures in the     presence of an inflammatory mediators. Phase 2: An in vivo model utilizing mature teeth     previously treatment planned for extraction, treating with PRF, reimplanting teeth and     following for three to four months before extracting and performing histological analysis. If     PRF is capable of promoting revascularization in mature teeth the potential benefits extend     to limiting the need for endodontic therapy following mature tooth avulsion, potential for     mature tooth transplantation in situations of congenitally missing teeth, and utilization of     PRF in endodontic revascularization therapy.   "
61749|NCT02477345|"     This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The     protocol involves infants and children with parenteral nutrition-associated liver disease to     enable the reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).   "
61750|NCT02477332|"     This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and     safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic     Spontaneous Urticaria.   "
61751|NCT02477319|"     identify and validate biomarkers that might reflect partial restoration of CFTR function and     can be used to monitor disease progression, and ii) evaluate the mechanistic effects of CFTR     modulators and other relevant therapies in individuals with CF   "
61752|NCT02477306|"     Comparative randomized, single dose, two-way crossover open-label study to determine the     bioequivalence of Rabeprazole from Idiazole 20mg DR tabs (GSK, Egypt)and PARIET 20 mg DR tabs     (JANSSEN, EGYPT) after a single oral dose administration of each to healthy adults under     fasting conditions.   "
61753|NCT02477293|"     The purpose of this study is to evaluate the safety and effectiveness of     Hyeonggaeyeongyo-Tang for chronic rhinitis according to pattern identification in Korean     medicine.   "
61793|NCT02476773|"     Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus     hookworm life cycle that are thought to play a role in the parasite's degradation of host     hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has     protected dogs and hamsters from infection in challenge studies. This study will evaluate the     safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian     adults living in an area of endemic hookworm infection.   "
61754|NCT02477280|"     Aim: The purpose of the study is to examine the effects of medication, placebo and     expectation on objective and self-rated performance of ADHD core signs during the Quantified     Behavior Test in patients with untreated ADHD and substance Use Disorders.      Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric     investigation at the Dependence Clinic Västmanland, Västerås, Sweden.      Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The     study is taken place during four hours on two investigating days, separated by a 4 days     wash-out period.      All patients participate on two occasions: In one session they receive the Methylphenidate     (MPH) condition, and in the other session they receive the placebo condition. MPH and placebo     conditions are counterbalanced across subjects such that half of the participants receive MPH     first, and half receive placebo first. Neither the patient nor the research assistant is     aware when the participant receive the MPH condition or the placebo condition.      On each investigating day the participant accomplish Questionnaires (Visual Analogical     Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise, (d)     perceived help from the pill and (e) self-rated symptoms. In addition the participant     completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test     Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective information     regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity measured with     the camera, and inattention and impulsivity on basis of the CPT-test.   "
61755|NCT02477267|"     The primary objective of this study is to compare the bioavailability of a test formulation     of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone®     (buprenorphine and naloxone) sublingual film, under fasted conditions.   "
61756|NCT02477254|"     To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE     and healthy controls.   "
61757|NCT02477241|"     Overactive Bladder syndrome (OAB) is a medical condition with symptoms of urgency, with or     without incontinence, usually with frequency and nocturia, with no proven infection or     obvious pathology 1. This study will explore the relationship between OAB, obstruction and     the micro contractions as well as the brain areas involved in both normal desire to void and     urgency, gaining a better understanding of the bladder pathophysiology and in the future     allowing better strategy of treatment options for patients suffering from OAB.   "
61758|NCT02477228|"     Endoscopic sphincterotomy is now an established method for removal of common bile duct     calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary     carcinoma. It is also generally performed prior to biliary stent placement .Anatomical     variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and     post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (CBD)     cannulations . In these situations, the success of CBD cannulation can be enhanced slightly     by using the various accessories designed for this purpose.The aim of this study is to     prospectively compare conventional approach and needle knife fistulotomy in cannulation of     ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding     procedure-related complications as failure of cannulations, bleeding and perforation and     postoperative complication   "
61759|NCT02477215|"     This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that     are associated with an acceptable adverse event profile when delivered together in 28-day     cycles. Additionally, the study aims to assess the efficacy of the combination in patients     with relapsed/refractory multiple myeloma. Responders (stable disease or more), will continue     to receive up to eight cycles total in the absence of further progressive disease.   "
61764|NCT02477150|"     To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE.   "
62936|NCT02461862|"     Cross-sectional cohort study to evaluating pain and vital signs variations (blood pressure     and radial pulse) during the placement of the intrauterine device.   "
61765|NCT02477137|"     The purpose of this study is to evaluate the effects of an interactive ICT-platform for use     in a smartphone or tablet in patients treated with radiotherapy for prostate cancer. The     hypothesis is that clinical management will be improved and costs reduced and safe and     participatory care promoted, when patients report symptoms in an application which provides     self-care advice and instant access to professionals.   "
61766|NCT02477124|"     The purpose of this study is to see if the transvaginal colposcope produces similar results     to colposcopy for the screening of cervical cancer. In this study the investigators are using     an investigational device called the transvaginal colposcope. The word investigational means     that the device is still being tested in research studies and is not approved by the U.S.     Food and Drug Administration (FDA).   "
61767|NCT02477111|"     INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the     study is to continue to evaluate the safety and effectiveness/performance of Incraft in     subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical     practice. Approximately 150 subjects will be enrolled and followed through 5-years     postprocedure. Up to 25 sites in Europe may participate.   "
61768|NCT02477098|"     Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing     abdominal surgery with a midline incision. It has proved to be effective in preoperative     block, but it has not been previously compared with postoperative block. The aim of the     present study is to evaluate postoperative pain, sleep quality and changes in the cytokine     levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus     postoperatively.   "
61769|NCT02477085|"     Since it is a frequent intervention in Obstetrics, labor induction is rarely evaluated from     national population-based cohorts. The study aims to assess the frequency of different     induction methods used in France from a prospective population-based cohort of women with an     induced labor. Maternal, fetal and neonatal outcomes will be compared between the different     induction methods. Moreover the adhesion to national clinical guidelines concerning the     induction of labor will be studied from this population-based cohort.      Finally the women satisfaction will be assessed according to the induction method used.   "
62434|NCT02468401|"     There is a pressing need to find effective strategies for the prevention of contrast induced     nephropathy in patients with advanced renal dysfunction. The current study was designed to     assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients     with advanced renal dysfunction undergoing coronary interventions   "
61772|NCT02477046|"     The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace     trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine     (IPV) in routine immunization globally, to be instituted in 2015-2016. At the community     level, the impact of the change from tOPV + IPV to bOPV + IPV on Sabin virus fecal-oral     transmission (duration of circulation, degree of genetic reversion) and the persistence of     environmental contamination are unknown. Also unknown is the impact of the change from tOPV     to bOPV on community circulation of Sabin 2 after a special immunization (SI) activity with     monovalent oral poliovirus type 2 (mOPV2). Finally it is unknown at the level of an     individual child if type 2 fecal shedding will be limited by cross-protection from oral     vaccination with Sabin type 1 and 3.      The investigators propose to measure at a community level transmission of Sabin 2 virus in     Bangladesh, a low income country, where fecal-oral transmission and environmental exposures     are high, comparing transmission in the setting of vaccination with tOPV+IPV vs. bOPV+IPV.     The study will be conducted in 67 villages in Matlab, Bangladesh, using a cluster-randomized     study design. Villages in Matlab will be randomly assigned to receive as part of routine     immunization (RI) activities: (1) tOPV (6,10,14 weeks) plus IPV at 14 weeks; (2) bOPV (6,10,     14 weeks) plus IPV at 14 weeks; or (3) bOPV (6,10, 14 weeks) plus IPV at 14 and 18 weeks.     Community and environmental surveillance for Sabin 2 virus will be conducted in each village     over the 9 month period of these RI activities. In addition, a SI activity with mOPV2 will     occur 9 months into the study to model an outbreak response. For the 6 months following the     mOPV2 challenge, the impact of the different vaccination regimens on Sabin 2 transmission in     the community will be determined, as well as individual level protection (as measured by     fecal shedding from days 7-70 after mOPV2 challenge).   "
61773|NCT02477033|"     During this project the safety, tolerability and effect on gut microbiota of oral     administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers     by a placebo-controlled cross-over randomized study.   "
61774|NCT02477020|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063     compared with placebo in treatment of acutely exacerbated schizophrenia.   "
61775|NCT02477007|"     The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and     ibuprofen in association with morphine, compared with morphine alone on analgesia in children     seen in the emergency department for a long-bone fracture and also to study the potential     synergic effect of the association paracetamol and ibuprofen.   "
61776|NCT02476994|"     This will be a descriptive study designed to evaluate the propensity for hospitalized     pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days     to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will     evaluate the safety and efficacy of using Clinolipid in a pediatric population.   "
61777|NCT02476981|"     This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored     anaesthesia care (MAC) during minimally invasive corrections of vertebral compression     fracture (vertebroplasty (VP) and kyphoplasty (KP)).      In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received     remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple     hemodynamic variables of patients were recorded and the frequency of oxygen desaturation,     respiratory depression, intraoperative need for other opioids, recovery time, operator     satisfaction score, and patients' overall pain experiences were also compared.      The investigators are expecting that both remifentanil and dexmedetomidine appear to be quite     safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC during VP     and KP in elderly patients.   "
61789|NCT02476825|"     This is a randomized, single-blind, controlled, single centre bronchoscopy study designed to     assess the effects of fluticasone propionate on airway gene expression and cellularity in     healthy adult controls without asthma.   "
61778|NCT02476968|"     This is a prospective, open-label, single arm, multi-center study to assess the real world     clinical effectiveness and safety of olaparib maintenance monotherapy as the capsule     formulation (in line with the EU approved prescribing information) and will be conducted in     platinum-sensitive relapsed high grade epithelial ovarian cancer patients (including patients     with primary peritoneal and / or fallopian tube cancer) who carry germline or somatic BRCA     mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or     suspected deleterious [known or predicted to be detrimental/lead to loss of function]).   "
61779|NCT02476955|"     An Open-label Phase 1b Study of ARQ 092 in Combination with Carboplatin Plus Paclitaxel, in     Combination with Paclitaxel, or in Combination with Anastrozole in Subjects with Selected     Solid Tumors   "
61780|NCT02476942|"     This non-interventional study will prospectively collect detailed, high-quality documentation     of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors     treated according to local routine clinical practice (receiving FVIII replacement or     bypassing agents as either episodic or prophylactic treatment). Actual patients will be     enrolled from routine clinical practice in this observational study.   "
61781|NCT02476929|"     Introduction: Rhinitis, sinonasal polyposis (SP) and asthma are diseases whose pathogenesis     is based on inflammation. This will determine the presence of disease, its evolution and its     treatment. It is therefore very important to develop and validate methodologies that allow us     to noninvasively detect inflammation of the airways. Thus, just as exhaled nitric oxide     (FeNO) has been studied as an important non-invasive marker of inflammation of the lower     airways, nasal nitric oxide (nNO) may be a good marker of nasal inflammation. Furthermore,     the electronic nose is an electronic nanosensor device capable of detecting specific volatile     organic compounds (VOCs) that can be used as a non-invasive biomarker of biochemical     processes in different diseases whose pathophysiology is also based on inflammation.      Objective: To determine reference values of nNO and different patterns of VOCs in healthy     individuals, individuals with allergic rhinitis (AR) and non-allergic rhinitis and     individuals with SP and asthma.      Methodology: Prospective, controlled study. Four groups will be included: Healthy subjects,     patients with AR, non-allergic rhinitis and patients with SP and asthma (n=252). Prick-test     to pneumoallergens will be performed. Determination of FeNO, nNO, lung function tests,     measurement of VOCs by the electronic nose and blood samples will be taken. Bilateral nasal     endoscopy and sample collection using the technique of brushing of mucosa and the placement     of filter papers, for the study of nasal cytology and mediators of inflammation.   "
61782|NCT02476916|"     Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of     different dose levels of AG-348 in patients with PK deficiency.   "
61816|NCT02476474|"     Laparoscopic Sleeve Gastrectomy (LSG) creates a vertical gastrectomy which results in a     narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus     (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric     emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve     resection in each center, this can result in difference of the remaining gastric antrum which     may affect gastric emptying time after this procedure.   "
61783|NCT02476903|"     Hip arthroscopy is a rapidly evolving procedure that has seen an exponential increase in the     number of cases performed yearly. With hip arthroscopy still in its infancy in relation to     knee and shoulder arthroscopy, there are still many questions yet to be answered. Axioms that     were once thought to be true regarding indications and treatment for hip arthroscopy are     continually being revised. As with the knee and shoulder before it, the hip is now graduating     into treatment avenues that were otherwise thought to only be possible through an open     surgical procedure.      Viscosupplementation in patients post arthroscopy with known articular cartilage injury has     been shown to be efficacious. The pathophysiology of hyaline degradation during the arthritic     process within the knee has been studied, and with this understanding has grown the     widespread usage of viscosupplementation. While questions still exist regarding the     effectiveness of viscosupplementation in non-weightbearing joints, it appears the benefits     seen in the weight bearing joints, such as the knee, are apparent   "
61784|NCT02476890|"     This is a double-blind, randomized, 2 period, crossover study in up to 36 healthy and chronic     cough subjects.   "
61785|NCT02476877|"     The prevalence estimates for specific mental disorders and illicit drugs have been separately     reported in U.S. government surveys. Less is known about the rates for specific comorbid     conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse,     bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects     that different demographic characteristics (ethnic background, family medical history, age,     living conditions [e.g., living with a single parent]) have on the prevalence of comorbid     mental illness and substance abuse also have not been considered. More should be known about     the duration of substance abuse in different mental illnesses among those undergoing     treatment, and whether specific types of drugs are associated with specific mental illnesses.      In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence     rates for the specific comorbid conditions and demographic relationships described above.     This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from     1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression,     bipolar disorder, or anxiety disorder) as determined by DSM-IV (The Fourth Edition of the     Diagnostic and Statistical Manual of Mental Disorders). The samples will be analyzed for both     prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be     collected at three time points: 1) immediately after enrollment and obtaining informed     consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6     months).   "
61786|NCT02476864|"     A study conducted in healthy adults to investigate if a new macitentan tablet leads to the     same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as     the marketed macitentan tablet.   "
61787|NCT02476851|"     This study evaluates whether whole blood transferred through the new POLFA needle assembly     meets supernatant hemoglobin acceptability standards.   "
61788|NCT02476838|"     The purpose of this study is to see if an investigational surgery that transfers tissue from     a non-living donor to living individual will help restore greater function, appearance, and     sensation to the hand and forearm areas of individuals who have suffered traumatic injury to     the hand and forearm.      This procedure is called a hand allotransplantation or hand transplant.      This study will also collect data on how patients do during and after having a hand     transplant from a nonliving donor. Recovery and outcomes will be observed through clinical     exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up     visits.   "
90233|NCT02104986|"     The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for     treatment of extra cranial NSMGCT in children and adolescent.   "
61790|NCT02476812|"     Investigators will conduct a randomized controlled trial of a 30-day positive activities     intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to     their scheduled appointment to undergo epidural steroid injection, all patients meeting study     criteria will be contacted by research staff to be invited to participate in this study.     Those interested will be asked to arrive 45 minutes before their regularly scheduled     appointment. At that time they will learn more about the study and provide informed consent     if they choose to participate. Participants will then complete the study questionnaires and     be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control group     (n = 100). All participants will receive the usual treatment provided at the Back & Pain     Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance of     medication regimen, standard office visits). Post-intervention (Day 30) and 2 months after     that (Day 90), participants will complete the same questionnaires by mail. The primary     outcome will be improved functional status, while secondary outcomes will be symptomatic     (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period,     the patients in the Wait List control will be offered the Positive Piggy Bank intervention     and will be asked to complete one more set of questionnaires at 30 days by mail.   "
61791|NCT02476799|"     Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative     analgesic effect for abdominal surgery with midline incision. Laparoscopic gynecologic     surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage     the pain.The purpose of this study is to investigate the analgesic effect of     ultrasound-guided RSB to multi-port laparoscopic gynecologic surgery which has incision site     at umbilical area. Patients will randomly assigned to two groups, RSB group and Control     group. Each patients will assessed for time to first rescue analgesia, verbal numerical     rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by     IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.   "
61792|NCT02476786|"     Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can     be identified. These trials have also demonstrated that there are not adverse effects on     overall outcome if women are treated with neoadjuvant endocrine therapy for several months     prior to definitive treatment. A new standard of care needs to be defined for elderly women     with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from     endocrine therapy alone to treat their cancer without compromising local and distant control.     The investigators hypothesize that endocrine therapy alone provides adequate local and     systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast     cancer and low Ki67 scores.   "
61794|NCT02476760|"     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2     diabetes) taken either alone or in combination with other anti-diabetic drugs are associated     with an increased risk of acute pancreatitis (AP) compared to other combinations of oral     hypoglycemic agents (OHA).      The investigators will carry out separate population based cohort studies using     administrative health databases in six jurisdictions in Canada, the US, and the UK. Cohorts     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs     entered the market, with follow-up until hospitalization for AP. The results from the     separate sites will be combined to provide an overall assessment of the risk of AP in users     of incretin-based drugs and by class of incretin-based drugs.   "
61795|NCT02476747|"     The investigators will investigate the efficacy of EMR compared to CSP in treatment of small     colon polp (6~10mm).      One aim of this study was to investigate the necessity of EMR on resection of small colon     polyp.   "
61796|NCT02476734|"     In this study the investigators would like to describe FDG-PET/CT responses in patients who     are receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell     Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects will     undergo two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan     at about 1 month after infusion.   "
61797|NCT02476721|"     The clinical presentation of acute pulmonary embolism ranges from mild dyspnea and cough to     shock or sustained hypotension but it also may even be asymptomatic and diagnosed by imaging     procedures performed for other purposes. (1) Depending on the clinical presentation, the case     fatality rate for acute pulmonary embolism ranges from 1% up to 60%. Due to the often     non-specific presentation, especially in mild to moderate acute pulmonary embolism PE is     often underdiagnosed. Chest pain and shortness of breath are the two most common symptoms     associated with pulmonary embolism, together these symptoms are responsible for approximately     10 million emergency department visits in the United States of America (US) (2). The aim of     this study was to determine the sensitivity and specificity of diagnosing pulmonary embolism     (PE) at the emergency department (ED) of the University Hospital Basel and the investigators     have therefore retrospectively analyzed all cases with excluded or proven PE in our     institution in the last three years. Data sets from the institute of radiology, the institute     of pathology and the ED are consistently available from January 2011 until the present day     and were screened for pulmonary embolism in discharge reports. Data from the ED include all     patients between January 2011 and December 2013 that presented to the ED and received either     an ECG or any form of thoracic imaging. Particular attention was paid to patients with PE in     the discharge report. The third set of data includes all patients with PE as cause of death     or as a secondary diagnosis in the autopsy report. After comparing the three sets of data to     each other the investigators tried to determine the sensitivity and specificity of PE     diagnosis at the ED respectively the rate of missed diagnoses. A PE was seen as missed if it     is detected 24h after the patient presented to the ED or if it was detected at another     department after the patient was transferred from the ED.   "
61798|NCT02476708|"     This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot     clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The     primary aim of this pilot trial is to provide an effect size estimate for the efficacy of     curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to     determine the effect of curcumin over time on negative and positive symptoms, in association     with inflammatory markers.   "
61843|NCT02476123|"     The purpose of this study is to characterize the safety and tolerability and determine the     maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of     Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.   "
61799|NCT02476695|"     This prospective and multicenter study is to determine the diagnostic performance (accuracy,     specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis     assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the     reference.      Approximately 600 patients will be enrolled to guarantee 500 final statistical cases; and     ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of     cirrhosis), respectively. For each stage, the case is assigned as equally as possible.   "
61800|NCT02476682|"     The purpose of this study is to determine the clinical utility of stool and blood methylation     tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated polyps (SSP).   "
61801|NCT02476669|"     Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China, Hong Kong, Taiwan,     Singapore and Malaysia. It is highly associated with Epstein-Barr virus (EBV). Radiation     therapy alone is indicated for early stage I to II diseases while concurrent chemoradiation     is required for more advanced stage III to IVB diseases. Intensity-modulated radiation     therapy (IMRT) is the standard radiation technique for NPC, in virtue of its superior target     coverage and dose sparing to adjacent critical organs-at-risks.      Plasma EBV DNA and other novel plasma biomarkers have been extensively investigated in NPC.     Previous studies have proven their predictive and prognostic values in NPC diagnosis,     surveillance and survival outcomes.      We would like to investigate the roles of plasma biomarkers including plasma EBV DNA on     treatment response evaluation, survival and prognosis on NPC, in the modern era of precision     radiation therapy.   "
61802|NCT02476656|"     Objective of study is to explore expression of stress-related genes and inflammation in     placentas and umbilical cord blood for women participating in group prenatal care compared     with women receiving individual prenatal care.   "
61803|NCT02476643|"     This study aims to test, if a two-week integrative therapy in an internal medicine ward will     improve symptoms, disability and quality of life in patients with inflammatory bowel disease     or irritable bowel syndrome.a It shall further be tested, if those changes are associated     with attitudes and experiences towards complementary and alternative medicine, anxiety,     depression and stress perception as well as body awareness and responsiveness.   "
61804|NCT02476630|"     Oxygen concentration for patients undergoing cardiac catheterization and during admission to     an intensive care unit is important outcome measure for clinical care. Currently, the tool     used to monitor the oxygen concentration is a central venous access positioned in the     superior vena cava or in the pulmonary artery to monitor the central venous oxygen saturation     (ScvO2). However, it is invasive and not always possible due to a lack of a central line     access. In this research study, the investigator would like use a noninvasive means for the     ScvO2 by using the thenar tissue oxygen concentration (StO2). The primary aim for the study     is to determine if the thenar StO2 correlates with ScvO2 and can serve as a noninvasive     surrogate for ScvO2.   "
61805|NCT02476617|"     A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic     HCV GT1a treatment-naïve and pegylated-interferon (pegIFN)/RBV treatment-experienced adults     receiving treatment with ombitasvir/ABT-450/ritonavir and dasabuvir coadministered with RBV     for 12 weeks.   "
61806|NCT02476604|"     It is widely acknowledged that cardiovascular disease prevention requires intervention as     early in the human lifespan as practical. A window of opportunity presents in early adulthood     when students gain independence as young adults attending university. In a three-phase     investigation, this study will evaluate the behavioral patterns of university students in the     domains of diet, exercise, stress management, smoking and sleep (phase 1). Informed with     information from phase 1, a pilot study (phase 2) will test the feasibility of performing an     intervention in university students consisting of an 8-week period during which the students     will receive up to six text messages (by phone or iPad) per week, tailored to address the     behavioral issues that the student has identified as needing improvement and for which the     student has indicated a desire to make change. Using lessons learned in phase 2, a     randomized, controlled trial of the 8 week intervention (phase 3) will compare intervention     subjects with controls for outcomes of behavior change, measures of anthropometric data, and     serum markers of cardiovascular risk to test the impact of the intervention   "
61807|NCT02476591|"     To investigate the effects of the availability of daily patient-related charges on ordering     patterns of health care ordering providers and cost containment in the Intensive Care Unit     (ICU) setting.   "
61808|NCT02476578|"     The purpose of this study is to determine whether alerting primary care providers by email     about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall     survival and other health indexes of people older than 75 years.   "
61809|NCT02476565|"     The investigators plan to conduct a randomized trial comparing the efficacy of intubating the     tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic     devices   "
61810|NCT02476552|"     This is an open-label study with 2 parts, plus an extension study following completion of     Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6     subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and     absolute bioavailability of niraparib.   "
61811|NCT02476539|"     The purposes of this study are to assess the safety, tolerability and pharmacokinetics of     Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the     treatment of HER2-positive advanced breast cancer.      The study will be conducted in two parts. Part one, trial will be conducted in 18-30 subjects     to determine safety and tolerability of Hemay022 in patients with HER2-positive advanced     breast cancer. Part two, approximately 27 additional subjects with HER2-positive advanced     breast cancer, are included to better define the tolerability and preliminary efficacy of     Hemay022.   "
61812|NCT02476526|"     The purpose of this study is to show that the use of low volume iso-osmolar non-ionic radio     contrast medium (30 cc) in a thoracic CT Scanning procedure in a selected group of patients     with chronic kidney disease (CKD) will avoid contrast induced nephropathy (CIN) in comparison     to a similar group of patients with CKD who receive no contrast medium..   "
61844|NCT02476110|"     Hypothesis : At hospital discharge for home, the medical prescription of ONS according to the     official criteria of SSNC and the legal regulations (completed prescription according to     health's insurance and homecare delivery) dictates the compliance of the patient and the     reimbursement of the ONS.   "
61813|NCT02476513|"     In this study,the investigators will evaluate participants that have clinical features     associated with an increased risk of esophageal disorders.The investigators will also see if     there is a positive association of esophageal disorders in men,40-60 with or without     abdominal obesity in the diagnosis of the following diseases; Gastroesophageal reflux     disease, Barrett Esophagus and Esophageal Adenocarcinoma. The investigators hypothesize that     most obese patients referred for Esophagogastroduodenoscopy will exhibit esophageal     disorders. Since currently the rates of obesity and adenocarcinoma of the esophagus have     increased significantly over the past 15 years, the investigators hope to find biochemical     markers (i.e. pro-inflammatory mediators) in the esophagus. The investigators hope these     samples will lead us to a differential expression of molecular markers and inflammatory     mediators in the varying degrees of esophageal disorder   "
61814|NCT02476500|"     In a prospective case-control study, 140 medical students (,novices') and 10 Senior     gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone     (LLETZ) on a Training model afte having undergone a Video Training session. Their     LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical     Skills (OSATS) protocol designed for judging the surgical proficiency when performing a     LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ training     model to distinguish between experts and novices will be assessed. Secondary endpoints are     differences in OSATS scores within the group of novices based on gender and handyness, as     well as satisfaction of the novices with the learning experience.   "
61815|NCT02476487|"     Background: Staphylococcus aureus bacteremia (SAB) is frequently encountered in hospitals,     with high rates of morbidity and mortality. Duration of antimicrobial treatment for SAB,     other than in cases of Infective endocarditis (IE), recommended by different guidelines     relies on risk stratification for relapse of infection rather than definite diagnosis of     septic foci that eventually determine the relapse rate. In recently published studies     fluorodeoxyglucose (FDG) PET CT was found to be a sensitive imaging test for identifying     metastatic infectious foci in Gram-positive bacteremia, including SAB.      Objectives: To examine the impact of using FDG PET CT in the diagnostic algorithm of non-IE     SAB compared to standard treatment recommendations on treatment duration and clinical     outcomes.      Methods: A prospective interventional non-comparative cohort study conducted at Rambam Health     Care Campus. Patients with SAB, defined as microbiologically and clinically, will undergo FDG     PET CT 10-14 days following the first positive blood culture for diagnosis of septic     extra-cardiac foci of infection. Patients with IE will be excluded. Short (2 weeks) versus     long treatment (4-6 weeks) will be recommended for negative and positive PET CT tests,     respectively. Patients will be followed-up for 1 year for relapse of infection and mortality.      We will document the sensitivity and specificity of PET CT for detection of complications     among patients with SAB. We will examine the percentage of patients in whom the use of PET CT     changed treatment duration compared to standard recommendations. We will compare also, the     relapse rate and 1 year mortality rate with data from previous studies and local data.     Assuming a 15% rate of management changes compared to consensus recommendations, a sample of     150 patients will achieve the required 95% CI.      Significance: Our trial will serve for improving decision making in patients with non-IE SAB,     shortening treatment duration in unnecessary cases and decreasing relapse rate by giving     prolonged appropriate treatment for metastatic infection not identified by standard     management algorithms. PET CT is assuming an increasingly important role in infection     diagnosis and management. The current study will be the first to examine the role of PET CT     in directing management of patients with SAB.   "
61817|NCT02476461|"     The purpose of this study is to investigate whether percutaneous needle fasciotomy is as     effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be     investigated, as iskontracture size after 5 years. Contracture size after one and three     years, and subjective hand function is also to be investigated.   "
61818|NCT02476448|"     This study evaluates 4 different methods to aid surgeons visualize ureteral jets on     cystoscopy.   "
61821|NCT02476409|"     Patients who present to clinic or in the outpatient setting with worsening heart failure     represent a unique opportunity for novel approaches to decongestion (removing fluid) that may     more rapidly improve fluid status and symptoms as well as reduce the risk of hospitalization.      In these patients with less severe congestion (fluid overload), combining the vasopressin     antagonist tolvaptan with loop diuretics (or fluid pills like     furosemide/bumetanide/torsemide) may represent a more effective strategy for decongestion. In     addition, looking at patients' copeptin levels may help identify those who are more likely to     respond to tolvaptan.   "
61822|NCT02476396|"     The purpose of the research is to understand structural plaque abnormalities that make a     carotid plaque unstable and brake off (embolize) which would help to predict and treat     individuals who are likely to suffer not only classic episodic major strokes but also     cognitive impairment.   "
61823|NCT02476383|"     This study considers whether treatment effects in response to spinal manipulative therapy for     individuals experiencing low back pain are dependent upon the context in which the     intervention is provided. Half of the participants will receive spinal manipulative therapy     with encouragement to interact with the provider and information to enhance expectations for     the effectiveness of the intervention. The other half will receive spinal manipulative     therapy with minimal interaction with the provider.   "
61824|NCT02476370|"     This study aims to test the effects of a Preoperative Relaxation intervention and an     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in     Patients Undergoing Herniotomy.   "
61825|NCT02476357|"     Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion     lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or     breast cancer were randomized in a controlled trial for surgical dissection technique.     Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and     oedema.   "
61826|NCT02476344|"     2 young candidates have tragically died during army pre-recruitment sorting series in 2006.     As part of the classification and characterization of the physical aspects of the training,     this experiment was requested.      We aim at determining the characteristics of physical strains in sorting series, by objective     and subjective parameters and evaluating the difficulty levels and intensity of those     strains.   "
61827|NCT02476331|"     Bipolar disorder (BD) is characterized by extreme changes in mood and emotion dysregulation.     Mood changes are episodic in nature, with distinct periods of mania, depression, and     asymptomatic periods of euthymia. In addition to impairments in mood, cognitive impairments     are a common feature of the disorder. These cognitive impairments persist during periods of     euthymia and are associated with negative clinical and psychosocial outcomes. Specifically,     individuals with BD show impairments in executive functions. Recent studies show that emotion     regulation can be down-regulated by taxing executive functions, and it can be improved with     working memory training, a specific component of executive functions. These initial studies     show that emotion regulation is under executive control in healthy individuals; however, the     nature of this relationship is not well understood in populations that are affected by     impairments in both executive control and emotion regulation. Previous work on cognitive     training has not targeted specific cognitive domains with an emphasis on understanding the     underlying mechanisms that promote change. Moreover, well-controlled randomized control trial     (RCT) studies are needed in order to provide high quality evidence to inform the efficacy of     cognitive training interventions for psychiatric populations. The aim of the proposed study     is to use a commercially available cognitive training program to study the effects of working     memory training on cognitive, clinical, and psychosocial outcomes in patients with BD. We     hypothesize that training working memory will lead to improvements in cognitive and emotional     functioning, leading to downstream changes that will positively impact untrained outcomes,     such as mood and community functioning.   "
61828|NCT02476318|"     A prospective, multi-center study to evaluate the safety and performance outcomes of the     ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis     between native vessel and synthetic vascular grafts.   "
61829|NCT02476305|"     Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from     musculoaponeurotic structures. Although they are benign tumors with no metastatic potential,     DT are considered as locally aggressive tumors, with local invasiveness and tissue     destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but is     limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall, root     members). In patients where surgery is considered, negative-margin resection (R0) is     recommended, but this frequently results in cosmetic/functional impairment. Moreover,     prognostic impact of R0 resections remains controversial. The outcome after initial surgery     depends upon several factors such as age, tumor site, and tumor size as demonstrated by     recent data from the French Sarcoma Group.      Alternative therapies to DT surgery for front-line or recurrence include NSAID's,     anti-estrogens alone or in combination, -interferon, chemotherapy, targeted therapies or     radiation therapy. All of these medical approaches however may fail to achieve long-term     disease control and a number of patients suffer from irreducible pain, and disability from     tumor volume.      Cryoablation is a promising technique that is suitable for patients experiencing     extra-abdominal DT. The procedure is based on repeated cycles of freezing/passive thawing of     the tumor, leading to cell death. The technique has many advantages, among which: the     accurate control of iceball under real-time MRI or CT-scan monitoring (that is not possible     with other techniques such as radiofrequency), the lack of mutilation, the possibility of     repeating the procedure. The cryoablation procedure has proven to be beneficial for the     treatment of various tumors (liver metastases, breast, kidney). Recently, percutaneous     cryotherapy has been reported in the treatment of EAD tumors poorly suited to surgery, with     promising results.      In the light of these encouraging data, it is believed that patients with extra-abdominal DT     not amenable to surgery unless unacceptable surgical sequel and progressing after at least     two lines of adequate medical therapy (tamoxifen, NSAID or chemotherapy), could benefit from     the cryoablation procedure. Tumor cryotherapy-induced regression should allow symptoms     relief, prolonged progression-free survival and a better quality of life.   "
61830|NCT02476292|"     The purpose of this study is to learn about the impact of vasculitis on employment and income     in patients with different systemic vasculitides. All patients enrolled in the Vasculitis     Clinical Research Consortium (VCRC) Patient Contact Registry, living in USA or Canada, and     followed for more than 1 year since the vasculitis diagnosis will be invited via email to     participate in this study, based on an online survey.   "
61859|NCT02475915|"     This study is a two-arm prospective 1:1 randomised controlled trial comparing the proportion     of patients between:      Group 1: vorinostat/hydroxychloroquine/maraviroc (VHM) co-administered with anti-retroviral     therapy (ART) Group 2: ART only who are able to maintain HIV RNA < 50 copies/ml following     treatment interruption. Subjects will be recruited from RV254/SEARCH 010, an acute HIV     infection cohort conducted by the Thai Red Cross AIDS Research Centre in Bangkok, Thailand.     The study will run for a minimum of 34 weeks from screening.   "
61831|NCT02476279|"     Background: Pancreatitis is the most frequent complication of endoscopic retrograde     cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality,     and increased health care expenditures. Until recently, the only effective method of     preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement     (PSP), an intervention that is costly, time consuming, technically challenging, and     potentially dangerous. The investigators recently reported the results of a large randomized     controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory     drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%)     had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who     received indomethacin alone were less likely to develop PEP than those who received a     pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for     underlying differences in subject risk. If indomethacin were to obviate the need for PSP,     major clinical and cost benefits in ERCP practice could be realized.      Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of     rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP     pancreatitis in high-risk cases.      Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin     alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement     for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred     and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent     for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin     and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared.     In addition, the investigators will establish a quality-assured central repository of     biological specimens obtained from study participants, permitting future translational     research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms     by which non-steroidal anti-inflammatory drugs prevent this complication.   "
61832|NCT02476266|"     Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a     multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls     are commonly experienced in PD.The purpose of this study is to investigate the effects of two     different resistance training programs on improving balance and muscular strength to thereby     reduce the risk of falls in those with PD. This study will randomize individuals to one of     two groups, a power training group, or a strength training group. Both interventional groups     will participate in 12 weeks of resistance training, two times per week for an hour each     exercise session.   "
61833|NCT02476253|"     The purpose of the present study is to compare the adjunct treatment of metabolic or mixed     severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the     plasma pH vs no buffering therapy.      The study is a randomized multiple center clinical trial with the outcome as a primary     endpoint.   "
61878|NCT02475668|"     Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.   "
61835|NCT02476227|"     Catheter ablation in the treatment of atrial fibrillation (i.e. pulmonary vein isolation) is     now the most effective method of prevention of arrhythmia recurrence. Use of 3D     electroanatomical system is now a golden standard.      Background hypothesis is that automatic algorithm collecting ablation points during pulmonary     vein isolation (with certain catheter stability time, range of motion, and catheter-tissue     contact force) prevents forming the gaps in the ablation line, thus preventing pulmonary vein     reconnection and AF recurrence. The aim of the trial will be 1:1 comparison of the two     methods of pulmonary vein isolation: with manual vs. automatic collection of ablation points     using CARTO system and contact force catheter.   "
61836|NCT02476214|"     Prenatal care is defined as pregnancy-related health care services provided to a women     between conception and delivery. Early, comprehensive prenatal care can promote healthier     pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing     preexisting medical conditions, by providing health behavior advice, and by offering a     gateway into the health care system for socially disadvantaged women . The customary approach     for prenatal care includes routine individual care, which is provided by nurses and     physicians in healthcare clinics and hospitals. Since 1995, citizens of Israel, have been     entitled to health care services according to the National Health Insurance Law . Israeli     citizens are covered by National Health Insurance, and get maternal and child preventive     services including prenatal care by local Mother and Child Health Clinics . The prenatal care     is individual. A nurse meets with every registered pregnant women, assess the medical and     emotional condition and provide guidance related to the pregnancy week of the woman.      Since the 70, a number of group prenatal care intervention programs are described in the     literature. Group prenatal care is designed to answer the recommended content for prenatal     care for improving the quality of care and resulting in improved pregnancy outcome . The     group prenatal care includes three important components: risk assessment. Guidance and     support and combines them into the prenatal care22. Creation of the group provides a meeting     place for pregnant women. A safe place for sharing and learning from each other and to build     a community for mutual support .      The investigators hypothesize that, relative to women who receive standard individual     prenatal care, the women who receive group prenatal care will be more likely to:        1. Report higher levels of satisfaction. The investigators also anticipate higher levels of          staff satisfaction within the intervention group medical staff.        2. Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during          pregnancy, tests during pregnancy).        3. Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT,          first and second trimester screening, US)        4. have better perinatal outcomes: better health behaviors during pregnancy (e.g.,          nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low          birthweight,), and better postpartum indicators (e.g., increased breastfeeding);   "
61837|NCT02476201|"     The purpose of the study is to assess prospectively at 6 months the percentage of responder     patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left     Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.   "
61838|NCT02476188|"     The purpose of the study was to investigate the correlation between the nucleosome     concentration and the rate of recanalization after thrombolysis. All patients were admitted     to the Stroke Unit at the University Hospital Sainte-Anne where they received standard stroke     care. The investigators included all patients treated or not by intravenous thrombolysis for     anterior circulation stroke with or without vessel occlusion. Exclusion criteria were     neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of stroke and     stroke-specifics symptoms that had started earlier than 4.5 hours before admission.   "
61839|NCT02476175|"     The objective is to evaluate the efficacy and safety of adding mirabegron to an     antimuscarinic to treat urinary incontinence in children with Overactive Bladder that are     refractory to antimuscarinics.   "
61860|NCT02475902|"     The participants will complete a series of balance assessments with a licensed physical (PT)     or occupational therapist (OT) or qualified research assistant (RA) at Blue Marble Game Co or     in their respective homes at the start of the study, at crossover and upon completion of the     study. During this study a PT, OT, or RA trained in fall risk management will supervise the     instruction and practice by participants of the home exercise programs during the initial 2-3     hour introduction to the study activities. Participants will be asked to exercise 3/week for     one month then crossover to the alternative exercise program and exercise 3/week for a second     month.   "
61861|NCT02475889|"     It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human     carcinoma. However, there are insufficient studies on the immune modulation of tumor     microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME in     human cancer patients, investigators performed a retrospective study of a unique cohort of     patients who suffered from synchronous CRCLM.   "
61840|NCT02476162|"     Second malignant neoplasms and cardiac late effects are primary drivers of serious     non-recurrence morbidity and mortality in long term childhood cancer survivors. Cardiac late     effects have been most prominently associated with exposure to high doses of anthracyclines     or chest radiation. While increased recognition of late effects has resulted in risk-targeted     therapy and reductions in use of high dose radiation and anthracyclines for many patients,     these cardiotoxic exposures continue to be essential components of curative childhood cancer     therapy. In addition, as survivors age they are increasingly susceptible to other general     risk factors for cardiovascular disease recognized in the general population, such as     hypertension, obesity, dyslipidemia, and diabetes.      This study will evaluate a high blood pressure monitor (HBPM)-based intervention for the     early detection of pre-hypertension and prevention of clinical hypertension in survivors of     childhood cancer. Eligible and consenting participants will be randomized into one of three     groups:      GROUP 1: Instructed to measure blood pressure (BP) every day for 3 months. GROUP 2:     Instructed to measure BP for 7 consecutive days once a month, for 3 months.      GROUP 3: Instructed to measure blood pressure for 3 consecutive days each month, for 3     months.      The randomization to the above groups will be done using sequential assignment of newly     recruited participants based on a randomly ordered list.      PRIMARY OBJECTIVE:        -  Evaluate the feasibility of High Blood Pressure Monitoring (HBPM) for three consecutive          months using a remote blood pressure device provided to participants of the St. Jude          Lifetime cohort (SJLIFE) protocol.      SECONDARY OBJECTIVES:        -  Assess compliance with use of HBPM by measurement frequency, evaluating overall and          defined minimum use in each of the three different groups.        -  Assess compliance with use of HBPM by cell phone status, evaluating those with and          without a personal cell phone capable of connecting directly to the home blood pressure          monitoring device via Wi-Fi or Bluetooth network.   "
61841|NCT02476149|"     In keratoconus (KC) corneal thinning and protrusion can cause myopia and irregular     astigmatism, affecting vision. The biomechanical properties of the cornea is maintained by an     intricate collagen network, which is responsible for its shape and function. In KC this     collagen network is disrupted resulting in the cornea losing its shape and function.     Keratoconic changes are focal and localised to certain regions of the cornea and the early     detection of these changes is challenging. Screening methods include corneal topography     (evaluation of anterior corneal surface curvature), tomography (assessing the morphological     features of the anterior segment) and aberrometry (measuring the optical aberrations of the     eye). More recent research suggests that the biomechanical destabilization of the cornea may     precede topographic and tomographic evidence of KC. Management of KC depends on disease     severity with severe cases being treated with keratoplasty and less severe cases with     cornealcollagencrosslinking (CXL). CXL is an emerging technique, which aims to increase the     biomechanical strength of the keratoconic cornea. Despite strong evidence of changes in the     biomechanical properties in human corneas following CXL, there is a significant need for     accurate measures of biomechanical changes in vivo pre and post CXL. Until recently technical     limitations have restricted the ability to assess the biomechanical properties of the whole     cornea in vivo. With the introduction of the CorvisST (Oculus) it is now possible to assess     regional biomechanical behaviour of the cornea. The output from the device provides a variety     of parameters to indicate the cornea's biomechanical strength. To date, the association     between the deflection behaviours in various regions of the cornea in keratoconic eyes preand     post CXL has not been studied. In order to effectively assess the clinical benefits of CXL     such information is vital. The primary goal of this investigation is to investigate regional     biomechanical properties of the keratoconic eye before and after CXL.   "
61842|NCT02476136|"     Anxiety disorders are common disorders, which pose a major burden to society and the     individual. An anxiety disorder may be treated with medication, in particular with     antidepressants such as the selective serotonin reuptake inhibitors (SSRIs). However, much of     what is known about antidepressants is derived from research in depression rather than     anxiety. In recent years, researchers have found that antidepressants are more effective for     severely depressed patients than they are for patients with milder symptoms. It is possible     that a similar relationship between symptom severity and antidepressant efficacy exists for     anxiety disorders, but there is currently little evidence available to answer this question.     As antidepressants are frequently prescribed to patients with mild or moderate anxiety, a     clear understanding of their effectiveness across the severity range is vital to inform     treatment decisions. Therefore, the purpose of this meta-analysis is to examine whether     initial symptom severity affects antidepressant efficacy for anxiety disorders.   "
61845|NCT02476097|"     Objectives:      To compare the prevalence of clinical symptoms of stomach problems between patients with     progressive discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those     with sudden discontinuation of esomeprazole 40mg. The presence of clinical symptoms, as     reported in the modified-Proton Pump Inhibitor Acid Suppression Symptom Test (PASS) test will     be weekly assessed until 4 weeks after the inclusion.      Study design:      This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by     esomeprazole 40mg since 4 weeks or more, randomized to 1 week of placebo or one week of     esomeprazole 20mg.      The first day of the study (Day 0), three blood samples will be collected at fast to measure     chromogranine A (CgA), gastrinemia, and Helicobacter Pilory (HP) serology. Cytochrome P450     (CYP)2C19 activity will be assessed.      Then, at Day 1, the patients will receive esomeprazole 20mg or placebo for 7 days (Day1-8).      Participants will complete the PASS test once a week on the same weekday throughout the study     (Day8-D15-D22-D29), during a telephone interview or a consultation, if it was scheduled in     the clinical follow up of the study.      Duration of treatment:      Esomeprazole or placebo for one week (Day1-8) Omeprazole single dose (Day0) Time plan of     research      Duration for the patient:      The treatments will stop after 7 days. The questionnaires will be collected until the 4th     week, Day29.      Overall duration of inclusion: one year Maximal overall duration of the study: 365 days+29     days=394 days Maximal delay for communication of the results: 2 years   "
61846|NCT02476084|"     The purpose of this study is to determine the kinetics of change in quantitative measures of     joint inflammation by state of the art power Doppler vascular imaging and to identify     biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and     stool samples) from parallel cohorts of RA patients undergoing different treatments. This     will be achieved implementing MSUS assessments, standard laboratories techniques (such as     ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.   "
61872|NCT02475746|"     The purpose of this study is to evaluate the effect of itraconazole after multiple dose     administration on the single dose PK of PF-06372865.   "
61873|NCT02475733|"     This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam     and metronidazole versus meropenem in paediatric population (from 3 months to less than 18     years of age )with complicated intra-abdominal infections (cIAIs)   "
61874|NCT02475720|"     According to the recent report using EGFR tyrosine kinase inhibitors (EGFR-TKI), there is all     over survival of the EGFR gene mutation-positive NSCLC in a tendency to extension. However,     the real situation and the reason are not clarified.This observational study collects the     data of EGFR gene mutation-positive NSCLC approximately 2,000 from the medical record of     approximately 20 facilities in Japan and observes the treatment reality of EGFR gene     mutation-positive NSCLC.   "
62435|NCT02468388|"     The purpose of this study is to evaluate the clinical effect of chewing gum containing     maltitol, on re-mineralization of early caries following daily chewing for 6 months by school     children, compared to a xylitol gum, gum base and a no gum group.   "
61847|NCT02476071|"     The study, funded by the Bill and Melinda Gates Foundation, will test a novel demand     generation strategy, Stylish Man, to increase uptake of safe voluntary male circumcision     (VMC) for HIV in Rakai, Uganda. With President's Emergency Fund for AIDS Relief (PEPFAR)     funds, the Rakai Health Sciences Program (RHSP) provides VMC in Rakai District, Uganda. The     investigators' ongoing 54 village Rakai Community Cohort Study (RCCS), with community HIV     prevalence ranging from 6% to 42%, provides longitudinal data on rates of VMC coverage and on     HIV incidence. The investigators have preliminary evidence that VMC is reducing HIV incidence     in Rakai, but coverage remains suboptimal (as elsewhere in Africa), reducing program impact.     The investigators' data suggest that VMC supply is not the limiting factor, but that there     is a deficit in demand.      Based on extensive qualitative research, the investigators have developed and piloted an     innovative male-focused VMC demand generation strategy, the Stylish Man Program (SMP). The     VMP strives to demedicalize VMC by de-emphasizing health-focused messages and instead     stressing taking charge of your life. The SMP has two distinct but related elements: (1)     mass media (MM) via radio and posters; and (2) community-level mobilization via the Stylish     Man Event (SMEvent) which includes multimedia media (the Stylish Van, videos, music, health     promoters) into which the investigators have embedded VMC promotion, and immediate access to     services. In this study, the investigators will conduct a one year cluster randomized trial     of MM plus SMEvents (intervention arm) compared to MM alone (control), in 20 RCCS     communities, half randomzied to the intervention and half to the control arm.      The primary outcome will be intent-to-treat community-level rates of VMC coverage by arm,     ie., the percentage of non-muslim men in each arm who accept and adopt MMC. (Over 95% of     Muslim men in Rakai already receive male circumcision in infancy.) As secondary outcomes, we     will also monitor rates of key behaviors and HIV incidence, and compare them between arms and     to rates observed in communities in each arm prior to study initiation.   "
61848|NCT02476058|"     The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in     participants with Major Depressive Disorder (MDD).   "
61849|NCT02476045|"     Open label, randomized, multicenter, phase II study to compare the efficacy, in terms of     non-inferiority of progression-free survival (PFS), of maintenance with panitumumab alone     (arm B) as compared to panitumumab with 5-fluorouracil (5-FU) and leucovorin (LV) (arm A)     following induction treatment with 5-fluorouracil + leucovorin+oxaliplatin (FOLFOX-4) and     panitumumab in patients with RAS wild-type, metastatic colorectal cancer.      The study involves an induction phase with panitumumab as 1 hour intravenous infusion at the     dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines.      Before start of FOLFOX-4 plus panitumumab, at the time of enrollment, patients will be     immediately randomized electronically 1:1 to one of the two maintenance arms. Induction     treatment with FOLFOX-4 plus panitumumab will continue until progressive disease,     unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of     induction treatment, in presence of complete or partial response, or stable disease,     non-progressing patients will be allocated to one of the two pre-assigned maintenance arms:      A) 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until     progressive disease, unacceptable toxicity or informed consent withdrawal B) Panitumumab     alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or     informed consent withdrawal Imaging studies (thorax and abdominal CT or MRI scan) will be     performed at baseline (4 weeks prior enrollment) and every 8 weeks (4 cycles) during     treatment.   "
61850|NCT02476032|"     The purpose of the study is to evaluate the efficacy of Sensi-StopTM strips (Procter &     Gamble™) on the relief of dentinal hypersensitivity. In other words, do Sensi-StopTM strips     (Procter & Gamble™) reduce or eliminate cold sensitivity in teeth? In addition, the     investigators will evaluate whether there is a difference in the Sensi-StopTM strip (Procter     & Gamble™) effectiveness when the product is placed by a dental professional compared to     self-placement by the person with sensitive teeth. This product is not experimental.   "
61851|NCT02476019|"     The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of ISIS-FGFR4RX.   "
61852|NCT02476006|"     Primary Objective:      To provide patients with severe hypercholesterolemia at risk for subsequent cardiovascular     (CV) events and not adequately controlled with currently available lipid-modifying therapy     (LMT) access to alirocumab ahead of commercial availability and to document the overall     safety and tolerability of alirocumab in this patient population.      Secondary Objectives:      To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as     well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C),     high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of     treatment.      To document patient's acceptability of self-injection (Self Injection Assessment     Questionnaire, SIAQ).   "
61879|NCT02475655|"     The purpose of this study is to evaluate the safety and tolerability of ruxolitinib in     HIV-infected adults who are virologically suppressed and who are on antiretroviral therapy     (ART).   "
61853|NCT02475993|"     The purpose of this study is to test a web-aided, mobile-based PHR (Personal Health     Reporting) service to enhance SCD outpatient treatment after discharge from an acute care     setting, such as Duke University Medical Center's Day Hospital. SMART is a new mobile     application created by SickleSoft to increase patient involvement in their treatment and     improve patient to doctor communication. SMART is a self-monitoring and management service     for SCD patients and their treatment doctors. This study will test whether or not use of the     SMART mobile application will help develop the type of patient-doctor relationships that lead     to better health outcomes and a decrease in readmission to an acute care facility.   "
61854|NCT02475980|"     The purpose of this pilot study is to determine the feasibility of comprehensive     contraceptive counseling intervention in a pediatric emergency department and to determine     the impact of comprehensive contraception counseling on initiation of contraception among     sexually active adolescents presenting to a pediatric emergency department.   "
61855|NCT02475967|"     In the trial cardiac patients will be provided with unrestricted access to the web-based     eLearing platform for a one-month period.   "
61856|NCT02475954|"     When Veterans with Parkinson's disease (PD) suffer from depression, they are more likely to     experience disease complications, interpersonal difficulties with caregivers, and poorer     quality of life. Unfortunately, depression in Veterans with PD is inadequately treated at the     current time. Treatment for depressed Veterans with PD will require the elimination of     geographical barriers to care and approaches that address the unique aspects of PD. The     proposed study will be the first to explore a novel and innovative, PD-informed psychotherapy     package for depressed Veterans with PD and their Caregivers, delivered through video-to-home     telehealth. If the results of this proposal are promising, a much needed treatment can be     made available to Veterans with PD and their Caregivers across the country, regardless of     geographical location.   "
61862|NCT02475876|"     Developmental changes in physiology during childhood influence drug dosing. Failure to     account for these changes leads to improper dosing, which is associated with decreased drug     efficacy and safety in children. Population physiologically-based pharmacokinetic (PBPK)     modeling offers the opportunity to predict optimal drug dosing based on physiologic     parameters adjusted for developmental changes.      PBPK models are mathematical constructs that incorporate physiologic processes with drug     characteristics and genetic variances to characterize the dose-exposure relationship across     the age continuum. These models integrate drug-specific (e.g., metabolism, protein binding)     and systems-specific (e.g., organ size, blood flow) information to predict the effect of     different factors (e.g., age, genetic variants, disease) on drug exposure. By accounting for     these factors and using data from clinical trials to confirm the modeling, PBPK models can     reduce the number of children needed for clinical trials while maximizing dose-based efficacy     and safety.      This trial will evaluate a platform to prospectively validate population PBPK models in     children. The study drugs, clindamycin and Bactrim (aka TMP-SMX), are ideal candidates to     evaluate population PBPK models in children due to their differing physico-chemical     properties and elimination pathways. In addition, a trial of clindamycin and TMP-SMX has     broad clinical applicability, as both drugs are among the most commonly used agents to treat     gram-positive infections in infants and children.   "
61863|NCT02475863|"     This study compares the clinical effectiveness of a new algorithm (model-based warfarin     dosing) with standard practice (doctor's own judgement and intuition) designed to determine     the most appropriate anticoagulant dose of warfarin in children after congenital heart     surgery.   "
61864|NCT02475850|"     The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an     evidence-based, patient-centered multifactorial fall injury prevention strategy in community     dwelling older adults at risk of falls recruited from 86 primary care practices around the     U.S.   "
61880|NCT02475642|"     The purpose of this study is to compare the efficacy and safety of PV isolation with     continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT     (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.   "
61881|NCT02475629|"     This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of     ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.   "
90501|NCT02101489|"     This purpose of this study is to study is to see if intra-operative urethral length     measurement with the Foley catheter will improve the placement of a synthetic sling in the     mid-urethra.   "
61865|NCT02475837|"     The Objectives of this study are:        1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional          maturation when administered during the maturation process compared with placebo.        2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary          procedures to aid in fistula maturation compared with placebo.        3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for          hemodialysis compared with placebo.      This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be     conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will     be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health     Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The     investigators expect to enroll 128 patients. Patients will be assigned to treatment groups     with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation.     Patients will be stratified based on fistula location (lower arm versus upper arm).   "
61866|NCT02475824|"     This is a single-center, prospective, randomized, double-blinded study of consecutive     patients referred for ERCP. A recent study suggested that the addition of dexmedetomidine to     the midazolam-meperidine regimen (MMD)provided better sedative efficacy and a superior safety     profile during ERCP compared with a midazolam-meperidine regimen. Further study is warranted     to compare an MMD regimen with propofol-based regimen.      Randomization is performed by use of a computer-generated random allocations in a ratio of     1:1 in balanced blocks of 4. A separate sedating nurse, who don't participate in the study,     is the only person with knowledge of the sedation regimen. This separate nurse repeated the     injection of propofol and completed questionnaires.   "
61867|NCT02475811|"     One hundred healthy women with singleton pregnancies in the 1st stage of labor will be     included in the study, divided into two groups; Group A (n: 50 - women pregnant ± 34-37     weeks) & Group B (n: 50 - women pregnant ± 37+1-40 weeks). A 3D volume model of the right     fetal lung is generated & lung volume is calculated using VOCAL software. After child birth,     neonatal respiratory functions will be assessed using APGAR score at (1, 5 and 10 min)     together with occurrence of RDS and the further need for NICU admission and respiratory     support measurements.   "
61868|NCT02475798|"     The purpose of this extended study is to collect confirmatory safety and effectiveness data     on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the     commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac     aneurysms.   "
61869|NCT02475785|"     The purpose of this study is to determine if the Forsus Fatigue resistant Device appliance     with direct skeletal mini plates anchorage is capable of achievement of skeletal mandibular     effects while preventing the excessive proclination of the lower incisors at the end of the     treatment when compared to the conventional Forsus Fatigue resistant Device appliance applied     to the upper and lower dental arches in female patients with skeletal Class II malocclusion   "
61870|NCT02475772|"     Fifteen women with recurrent ovarian cancer will be treated by an intraperitoneal     chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of     the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4     weeks for three courses using a three-group, dose-escalation protocol with fixed     dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks.     Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The study     hypothesis is that local and systemic toxicity will increase with increasing dosage of     cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5     events in any treatment group.   "
61871|NCT02475759|"     Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized     controlled trial.   "
61875|NCT02475707|"     This research study uses special blood cells called multiple tumor-associated antigen     (TAA)-specific T cells (a new experimental therapy) to treat patients with acute     lymphoblastic leukemia (ALL) which has come back, or may come back, or has not gone away     after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT).      The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin     lymphomas that are infected with Epstein-Barr virus (EBV), the virus that causes infectious     mononucleosis (mono or the kissing disease), Epstein Barr virus (EBV). EBV is found in     cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This     suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are     able to hide from the body's immune system and escape being killed. The investigators     previously tested whether special white blood cells (called T cells) that were trained to     kill EBV-infected cells could affect these tumors, and in many patients the investigators     found that giving these trained T cells caused a complete or partial response.      In several lymphomas and other types of cancers like ALL, the cancer cells do not have EBV.     They do however express specific proteins that can be targeted in the same way. The     investigators have been able to infuse such tumor-targeted cells into up to 10 patients with     lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment     appears to be safe. Therefore, the investigators now want to test whether the investigators     can direct these special T cells against other types of cancers that carry similar proteins     called tumor-associated antigens (TAAs). These proteins are specific to the leukemia cell, so     they either do not show up, or show up in low quantities, on normal human cells.      The investigators will grow T cells from patients' stem cell donors in the laboratory in a     way that will train them to recognize the tumor proteins WT1, PRAME and Survivin, which are     expressed on most ALL cancer cells. The cells will be infused at least 30 days     post-allogeneic stem cell transplant. In this study, the investigators want to see whether     these cells will be able to recognize and kill leukemia cells that express these antigens.     These donor-derived multiTAA-specific T cells are an investigational product not yet approved     by the U.S. Food and Drug Administration.      The purpose of this study is to find the largest safe dose of donor-derived multiTAA-specific     T cells for patients with ALL.   "
61876|NCT02475694|"     The purpose of the present study is to visualize the inflammatory response and coagulation     disorders during cardiac surgery in order to identify possible predictors for acute lung     injury postoperatively.   "
61877|NCT02475681|"     This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil     compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of     previously untreated chronic lymphocytic leukemia (CLL).   "
61885|NCT02475577|"     The study will test a hypothesis that the remote monitoring with text and email alerts sent     to study subject and optional family/other caregiver (Intervention 1) will have a higher     return on investment compared to remote monitoring with nurse researcher follow-up telephone     communication to study subject (on Blue alerts) or study subject's healthcare professional     (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).   "
61886|NCT02475564|"     This study aims to verify whether the use of 40 mg of resveratrol per day associated with     monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic     pain at the end of 2 months of treatment, compared to the use of the pill with placebo.   "
61887|NCT02475551|"     This study will assess the safety and efficacy of IdeS in the transplantation setting. Each     patient will receive one dose of IdeS. If the crossmatch test is negative at the time of     transplantation, the patient will be transplanted with a kidney from a deceased or living     donor. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior     to surgery.   "
61888|NCT02475538|"     This study aims to examine the efficacy of electroacupuncture for tapering benzodiazepines in     long-term users. All eligible subjects will be randomized in a ratio of 1:1 to (1)     Electroacupuncture combined with gradual tapering; and (2) Placebo acupuncture combined with     gradual tapering.   "
61889|NCT02475525|"     The study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement     in the prevention of wound complications in the the wounds of patients post lower limb     revascularization.   "
61890|NCT02475512|"     Incontinence is a widespread problem in all health care setting. One of the main     complications of incontinence is inflammation of the skin in the genital and anal region,     also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of     pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.      The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus     standard care (traditional water and soap) for the prevention of IAD. The second aim is to     perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and     third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total     body wash. Other outcomes are the comfort and tolerance of both the nurses and participants.      In this Randomized Controlled Trial, performed in 13 long-term care settings, the     participants will undergo a 30 day study period. In the experimental intervention, the     participants will be washed with body wash wipes and genital wipes. In the control group, the     subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be     monitored. Subjective and objective time measurements will be performed.   "
61891|NCT02475499|"     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2     diabetes) taken either alone in or combination with other anti-diabetic drugs are associated     with an increased risk of pancreatic cancer (PC) compared to sulfonylureas.      The investigators will carry out separate population based cohort studies using     administrative health databases in five jurisdictions in Canada, the US, and the UK. Cohorts     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs     entered the market, with follow-up until hospitalization for PC. The results from the     separate sites will be combined to provide an overall assessment of the risk of PC in users     of incretin-based drugs and by class of incretin-based drugs.   "
61892|NCT02475486|"     Despite the large therapeutic arsenal available since one decade allowing a strong reduction     of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep     problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is     lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher     prevalence of non-inflammatory pain than general population. Fatigue is a real major problem     due to 50% of patients considered it as severe.      This dissociation between disease activity and fatigue level suggests that fatigue is     multifactorial. No consistent explanations for fatigue are currently available.   "
61893|NCT02475473|"     Study the responses of circulatory irisin to chronic high-intensity resistance training   "
61894|NCT02475460|"     The purpose of this study is to evaluate a less invasive implantation technique of the     HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.   "
61895|NCT02475447|"     Kappa-opioid receptors mediate the sensation of itch in animals and humans. Asimadoline is an     orally active, selective kappa-opioid receptor agonist and has demonstrated efficacy in     several preclinical pruritus models. The purpose of this Phase 2 study is to evaluate the     safety, tolerability and clinical efficacy of asimadoline in patients with pruritus     associated with atopic dermatitis.   "
61896|NCT02475434|"     At present, widespread use of the human milk-based caloric supplement (cream) has not     occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are     needed to support its adoption as a standard care practice.      The investigators hypothesize that infants who receive an exclusive human milk (HM)-based     diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a     shorter length of initial hospital stay compared to infants receiving the standard regimen of     an exclusive HM-based diet (Control group). The investigators hypothesize that the effects of     the cream caloric supplement will be greater in the subgroup of infants who develop BPD so     the relationship will be evaluated between Cream Supplement study group and postmenstrual age     (PMA) at discharge and the incidence of BPD.   "
61897|NCT02475421|"     The study aims to evaluate the elimination and degradation of glucagon in patients with type     2 diabetes compared to matched healthy subjects.   "
61910|NCT02475252|"     In a prospective case-control study, the investigators compare the Objective Structured     Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts     performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators     hypothesize that OSATS on a hysteroscopy training model has construct validity to     discriminate between experts and novices.   "
61911|NCT02475239|"     The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo     is the canalith repositioning procedure or the Epley maneuver. Based on the present     literature, there is controversy on the efficacy of post-maneuver postural restrictions.The     aim of this study was to conduct a randomized controlled trial to compare the treatment     efficacy of post-maneuver postural restriction with CRP alone in patients with posterior     semicircular canal benign paroxysmal positional vertigo.   "
61898|NCT02475408|"     Coronary artery disease and the benefit of bypasses:      Despite considerable advances in medicine, cardiovascular diseases remain the number one     cause of death globally, primarily consequence of myocardial infarction (MI). Coronary     collaterals exert a protective effect by providing an alternative source of blood flow to a     myocardial territory potentially affected by an acute coronary occlusion. Coronary     collaterals represent pre-existing inter-arterial anastomoses and as such are the natural     counter-part of surgically created bypasses. Sufficient coronary collaterals have been shown     to confer a significant benefit in terms of overall mortality and cardiovascular events. In     this regard, the concept of augmenting coronary collateral function as an alternative     treatment strategy to alter the course of CAD, as well as to control symptoms, is attractive.      Durable promotion of coronary collateral circulation:      Before the advent of coronary artery bypass grafting, permanent augmentation of coronary     collateral supply by a single structural modification has already been attempted. Bilateral     ligation of the internal mammary arteries (IMA) was performed in CAD patients to alleviate     angina pectoris and electrocardiographic (ECG) signs of ischemia. The prevalent in vivo     function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for     the first time - been recently demonstrated by our research group. The acute functional     changes observed in response to temporary distal IMA balloon occlusion are expected to result     in larger chronic structural adaptations of the IMA-to-coronary-artery connections when the     distal IMA is permanently occluded. In contrast to the previously employed arteriogenic     approaches in humans, the attractiveness of such an intervention lies in the potential     durability of the effect.      In a first step, catheter-based IMA occlusion ought to be conceptually investigated in the     setting of the less frequently grafted right IMA among patients with ischemia in the right     coronary artery territory.   "
61899|NCT02475395|"     The objective of the study is to evaluate the agreement in measurement of sperm concentration     in human semen between lay users with TRAK and a recognized reference method. The study will     also include the measurement of matched samples by TRAK when tested by healthcare     professionals trained in use of the TRAK device.   "
61900|NCT02475382|"     The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal     antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic     treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell     lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is     appropriate.   "
61901|NCT02475369|"     The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic     enzyme supplementation will improve symptoms in individuals with celiac disease who suffer     persistent symptoms despite a gluten free diet. This protocol specifically aims to:        1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of          gastrointestinal symptoms in patients with celiac disease on a gluten free diet.        2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme          supplementation in patients with celiac disease on a gluten free diet.   "
61902|NCT02475356|"     The primary objective in this study is collecting post-marketing information on the safety.     Thus, it includes information under the routine clinical practice on adverse events (AEs) and     adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the     first 12 months Mirena insertion.      The secondary objective(s) in this study is/are collecting information on Mirena     effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and     dysmenorrhea pain as far as these are recorded under routine clinical practice.   "
61903|NCT02475343|"     This study aims to use Schiotz tonometer to evaluate the corneal biomechanical properties.     The administration of Schiotz tonometer is according to the routine protocol which is use to     measure intra-ocular pressure. The results obtained from Schiotz tonometer will be compared     with results obtained from ORA and/or Corvis.   "
61904|NCT02475330|"     This single arm Phase II trial will investigate the feasibility of dietary flaxseed (FS)     supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung     cancer (NSCLC). Subjects will ingest FS for a period of approximately 8 to 9 weeks during the     course of radiation treatment. Study participation and surveillance will last approximately 6     months. Subject specimen collection will include: blood, urine, and buccal swabs at 5 time     points.   "
61905|NCT02475317|"     The purpose of this study is to assess the relative potency of multiple oral doses of LUM001     and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and     obese adult subjects. This study is designed to address the relative potency question for the     first time in the same.   "
61906|NCT02475304|"     The purpose of this study is to investigate, whether FP187 is effective in the treatment of     mild to moderate psoriatic arthritis.   "
61921|NCT02475109|"     The objective of this study is to assess the safety and tolerability of topical ocular     PAN-90806 in patients with proliferative diabetic retinopathy.   "
62439|NCT02468336|"     The objective of this study is to demonstrate that the investigational device, AngioDefender,     is comparable to the established procedure referred to as 'brachial artery ultrasound     imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.   "
61907|NCT02475291|"     Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary     angiography to assess the potential of a coronary stenosis to induce myocardial ischemia.     Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress     imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional     manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of     FFR for all angiographically significant stenoses would add considerable time, cost, and     complexity to each PCI procedure and might also increase the risk of catheter-related     complications such as coronary dissection and perforation. Although the guideline mentioned     that FFR may not be useful in very high grade lesions (angiographically >90%) which always     have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80     obtained by angiographic parameters including degree of stenosis, lesion location and vessel     size. It would be valuable to find more precise criteria available by conventional     angiography for discrimination of functional stenosis in way to reduce the risk of additional     procedure. For the purpose, the investigators will perform FFR in the lesions with     significant stenosis (>70% diameter stenosis by visual estimation) and compare the     angiographic parameters and FFR values in the study.   "
61908|NCT02475278|"     The purpose of this study is to collect serum samples to evaluate serologic assays and to     establish proficiency panels for serologic assays used for assessment of post vaccination     immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent     virus-like particle (VLP) vaccine.   "
61909|NCT02475265|"     Decreased bone strength is a common and serious medical problem present in many women with     anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones     than women with normal bone strength.      This study will investigate whether the use of transdermal estrogen can improve bone mineral     density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when     used for 6 months.   "
61912|NCT02475226|"     Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality.     In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed     to evaluate the relationship between mortality and the distribution of reason for and     resulting type of brain damage and to determine other factors affecting mortality.   "
61913|NCT02475213|"     The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination     with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous     cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial     Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest     dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments     will also be done to see how the drug acts in the body (pharmacokinetics (PK),     pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with     pembrolizumab.   "
61914|NCT02475200|"     The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry     sponsored by Volcano Corporation to evaluate the short and long term performance and clinical     outcomes of the Phoenix Atherectomy System.   "
61915|NCT02475187|"     Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events     over 2 years in 220 patients with hip fracture.   "
61916|NCT02475174|"     Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous     circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy     breast cancer.   "
61917|NCT02475161|"     The purpose of this study is to assess the effects of daily administration of rabeprazole on     the single-dose pharmacokinetics of JNJ-42847922 in healthy participants.   "
61918|NCT02475148|"     The purpose of this study is to investigate the safety and tolerability of JNJ-54175446     versus placebo after single oral dose administration (ascending dose levels), to determine     the maximal tolerated dose (MTD) or the safety and tolerability at exposures resulting in     full target engagement for at least 24 hours in all participants (whichever comes first), to     characterize the pharmacokinetics of JNJ-54175446 in plasma, cerebrospinal fluid (CSF) and     urine and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics     of JNJ 54175446 after single oral dose administration.   "
61919|NCT02475135|"     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of     Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose     combination (FDC) with darunavir (DRV) and cobicistat (COBI)     (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) relative to     administration as an FDC with Elvitegravir (EVG) and COBI     (Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), under fed conditions in     healthy subjects (Panel 1); evaluate the single-dose pharmacokinetics and relative     bioavailability of DRV, COBI, FTC and TAF when administered as an FDC (D/C/F/TAF) or as     separate agents (D+C+FTC/TAF), under fed conditions in healthy subjects (Panel 2) and to     evaluate the impact of food (fasting or high-fat breakfast) on the single-dose     pharmacokinetics of DRV, COBI, FTC, and TAF when administered as an FDC (D/C/F/TAF) in     healthy subjects (Panel 3).   "
61920|NCT02475122|"     Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time     of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a     life-threatening complication. The yearly incidence of the first variceal bleeding in     cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large     varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for     patient with medium or large varices a primary prophylaxis treatment with nonselective     beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico     Hepatology 2005).      The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure     gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment     reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG < 12     mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of patients. In     non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years.      In this situation, alternative treatments to beta-blockers have been suggested: endoscopic     ligation, which was shown to be as effective as beta blockers in primary prevention, and more     recently carvedilol (Reiberger, Gut 2012).      So, HVPG monitoring may provide critical information for patients. However, because of its     technical requirement and its invasivity, HVPG measurement is not feasible in clinical     practice . So, there is a general consensus to continue indefinitely beta blockers treatment     without control of hemodynamic efficiency (merkel J. Hepatology 2009).      Previous studies have suggested the interest of azygos blood flow measurements for evaluating     hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension     (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported     to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic     patients. Its feasibility is obviously higher than HVPG measurement.      However, in the same way that HVPG, a large-scale implementation in clinical practice of     azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or     relative post-therapeutic decrease, related with no variceal bleeding.   "
61922|NCT02475096|"     This pilot-study aims to evaluate the effect size and feasibility of internet-delivered     cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant     functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal     pain and functional dyspepsia according to the Rome III criteria). The main component     investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli     and situations. Children will participate along with one of their parents in the treatment.     The parents will also receive specific modules with information on how to support their child     in the treatment.   "
61923|NCT02475083|"     The aim of this study was to investigate the therapeutic effect of virtual reality associated     with conventional physiotherapy on balance during gait and the occurrence of falls in     patients after stroke.   "
61924|NCT02475070|"     The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects     on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2     diabetes and whether this is associated with effects on glucose homeostasis.   "
61925|NCT02475057|"     The purpose of this study is to test whether Degarelix is associated with less endothelial     dysfunction (an intermediate in the development of cardiac disease) and cardiovascular     biomarkers compared to LHRH agonists.   "
61926|NCT02475044|"     The purpose of this study is to investigate the role of psychosocial factors in creating     Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a)     Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do     socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution     for the child injury by their parents and (2) embracing of a more permissive and     authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does     Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral     symptoms?   "
61927|NCT02475031|"     The purpose of this study is to determine whether continuous transversus abdominis plane     (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor     nephrectomy   "
61930|NCT02474992|"     The purpose of this randomized controlled trial is to compare a social network-based     behavioral intervention known as microclinics to standard HIV clinical care alone in helping     patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to     clinic appointments. The study is designed to evaluate the effectiveness of microclinics on     reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard     HIV clinical care alone. By doing this research study, the investigators hope to learn     whether microclinics are a useful social strategy for improving delivery of HIV treatment in     rural Kenya.   "
61931|NCT02474979|"     Pressure ulcers (PU) cause pain and discomfort to affected patients, as well as considerable     costs for society. The present study will evaluate the effect of the Continuous Bedside     Pressure Mapping (CBPM)- system on PU prevalence and incidence. A RCT including 180 patients     will be conducted in a geriatric setting in a Swedish University hospital   "
61932|NCT02474966|"     The blood-brain barrier (BBB) is a specialized interface allowing a unique environment for     neuro-glia networks. BBB dysfunction is common in brain disorders. The Transcranial Magnetic     Stimulation (TMS) is a non-invasive method of stimulating cortical motor neurons with the use     of rapidly changing electromagnetic fields generated by a coil placed over the scalp. The     objective of this study is to evaluate the safety and effects of the deep TMS (dTMS) on     barrier integrity in patients with malignant glial tumors. BBB permeability will be     quantified using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Permeability     change will be compared between two DCE-MRI scans performed immediately after real and     sham rTMS, randomly assigned within one week of each other.   "
61933|NCT02474953|"     This study is investigating the pharmacokinetic profile (i.e. the way the product is     processed by the body) of a proprietary curcumin formulation compared to an unformulated     curcumin product. Subjects will take a single dose of either the proprietary formulation or     comparator product and the blood levels of curcumin and curcumin metabolites will be measured     over a period of 48 hours.   "
61934|NCT02474940|"     People with Multiple Sclerosis (MS) often have pain and/or fatigue. Unfortunately, available     treatments provide inadequate relief for the majority of these individuals. There remains an     urgent need for additional treatment options for MS-related symptoms. The purpose of this     study is to see if alternative treatments that involve self-hypnosis training, neurofeedback     training and/or mindfulness meditation training, or a combination of some of these treatments     can help decrease pain and fatigue in people with MS. A subject must have a diagnosis of MS,     have chronic pain and/or fatigue, and be at least 18 years old to participate, among other     criteria.   "
61935|NCT02474927|"     The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety     and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous     immunoglobulins for AMR after lung transplantation and elucidate important clinical and     immunologic phenotypes and mechanisms associated with these outcomes.   "
61936|NCT02474914|"     pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign     and malignant pancreatic and periampullary diseases. Despite improved surgical technique and     postoperative care, the mortality rate after PD is high reaching up to 30%, due to high     incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most     frequent complications of PD and the major contributor to postoperative morbidity The aim of     this study to evaluate the effect of the perioperative octreotide use after PD for prevention     of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative     complications, mortality and the cost benefit relationship of the use of the perioperative     octreotide.   "
61937|NCT02474901|"     The goal of this study is to determine if there is a difference in shedding (primary     objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and     HIV-negative children and young adults who are receiving the quadrivalent live-attenuated     influenza vaccine (QLAIV).   "
61952|NCT02474667|"     A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of     BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor     Kidney.      The major objective is to demonstrate the safety and efficacy of BB3 in reducing the severity     of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased     donor renal allograft.   "
61938|NCT02474888|"     The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels     could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.      All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or     the relapse of a known ANCA-associated vasculitis, in which the decision to start an     induction regimen with rituximab has been taken, will be included.      Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined     (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.   "
61939|NCT02474875|"     Education of pain physiology is described as an educational session or sessions describing     the neurobiology and neurophysiology of pain, and pain processing by the nervous system.     There is compelling evidence that an educational strategy addressing neurophysiology and     neurobiology of pain can have a positive effect on pain, disability, catastrophization, and     physical performance in chronic musculoskeletal pain disorders. Although pain physiology     education has been studied in patients with chronic low back pain, chronic whiplash, and     chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM)     are limited to a 2013 study with limited results.      The investigators propose a study with a higher dose of education of pain physiology (i.e. a     higher number of educational sessions and total education time) to study if this generates a     larger treatment effect in patients with fibromyalgia.   "
61940|NCT02474862|"     This study is a randomized control trial (RCT) evaluating a Prenatal Walking Program (PWP) in     comparison to a Postpartum Prep Program (PPP) comparison group for pregnant women     experiencing depressive symptoms. In addition to assessing changes in depressive symptoms,     the investigators will examine other key maternal outcomes (maternal functioning, pain,     anxiety, stress, fatigue), as well as infant outcomes including birth record data (gestation,     weight, Apgar scores, etc) and careful, in-person assessment of infant neurobiological     functioning at 30 days postpartum.   "
61941|NCT02474849|"     This study will compare nicotine delivery, heart rate, puffing parameters and product     satisfaction in healthy subjects either using several different types of electronic     cigarettes or smoking a conventional cigarette.   "
61989|NCT02474186|"     1. To induce immunity-mediated tumor response outside the radiation field (abscopal effect)          after chemo-radiation of a metastatic site in metastatic breast cancer patients.        2. To monitor the induction of a T cell response.        3. To explore the role of PET scanning to assess tumor responses/abscopal effect.   "
61942|NCT02474836|"     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic     and non-allergenic components. Many factors such as the variability, differences in     extraction process and subsequent handling of allergens can affect the final composition,     potency, and stability of allergen preparations. Genetic diversity of affected people adds     another level of complexity. In order to control variability and to achieve consistency and     reproducibility for optimal safety and sensitivity/specificity, it is essential to     standardize the amount of allergen used in prick tests. Therefore, the system for biological     standardization mainly used in Europe still is the biological calibration of in-House     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines     as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT)     value. The aim of this procedure is to estimate the biological activity of allergen extracts.     The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a     specific skin reaction with a wheal of the same size as a wheal provoked by reference     histamine at a concentration of 10 mg/ml, when both solutions are administrated using the     same technique (prick testing) on at least 20 individuals who are sensitized to the allergen     concerned.      The present study aims to standardize the allergen extracts of Artemisia vulgaris, Platanus     acerifolia, Dermatophagoides farinae by using this method.   "
61943|NCT02474823|"     A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor),     showed a positive maneuver (unable to wrap hands completely around neck) to be 100%     predictive of sleep apnea in a sleep clinic population. The investigators now would like to     compare ESAP to other tests used to diagnose and screen for Sleep Apnea in type 2 diabetics.     The tests will included Home Sleep Testing, sleep questionnaires Berlin and STOP-BANG and     polysomnogram (PSG). Patients with type 2 diabetes in the Bassett Endocrine Clinic who are     scheduled for a routine evaluation will be recruited to undergo; a Home Sleep Test along with     two sleep questionnaires PSG. The screen test wil be compared to the results of the gold     standard diagnostic test the PSG for their predictive value os OSA in the type 2 diabetic     population.   "
61944|NCT02474810|"     Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380     hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of     these catheters includes thrombosis and infection. Catheter locking solutions such as     recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and     prevent clotting of the catheter during HD treatments and during the interdialytic period.     Evidence to guide the use of rt-PA is limited. This quality assurance project will compare     the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol     for rt-PA in HD patients.   "
61953|NCT02474654|"     Study question: Is there an ideal combination of intraoperative long acting analgesics     (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to     optimize post-operative functional recovery, decrease overall narcotic consumption and enable     faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?   "
61954|NCT02474641|"     Hypofractionation with simultaneous integrated boost has been investigated in a few trials     and appears to be safe and feasible.      Investigators initiated this multicenter two-armed phase III prospective trial to analyse the     non-inferiority of hypofractionation with simultaneous integrated boost in patients with     early breast cancer in comparison to standard fractionation.   "
62025|NCT02473718|"     The purpose of the study is to determine if a protocol that assesses patients' daily fluid     intake and output can decrease the overall amount of fluid patients receive during the first     five days in the ICU. The study will also determine if decreasing overall fluids can decrease     adverse events associated with mechanical ventilation, such as ventilator-associated     pneumonias.      The protocol will include daily ultrasounds and blood draws to evaluate fluid balance.     Ultrasound will be used to measure changes in the diameter of the inferior vena cava with     respiration.   "
61945|NCT02474797|"     Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Aim of     this study is to assess diaphragmatic function with the Diaphragmatic Thickening Fraction     (DTF) ultrasound measure in patients with severe sepsis or septic shock, mechanically     ventilated or not, hospitalized in ICU in order to determinate diaphragmatic dysfunction     frequency, its prognosis value and its associated factors.      This is a prospective pilot study in a 14-bed medical and surgical ICU including 50     consecutive patients with severe sepsis or septic shock. The expected duration of study is 18     months.      DTF is measured each day as follow: the probe is placed in an intercostal space between mid     axillary line and anterior axillary line, 0.5cm to 2 centimeters below the costodiaphragmatic     sinus. DTF measure is performed in B-mode using the following formula: TF (%) =     [(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100]. A     DTF < 20% indicates a diaphragmatic dysfunction.      The investigators will collect potential factors for which DTF Ultrasound Measure could have     a prognosis value (intubation, successful or failed weaning from mechanical ventilation),     potential risk factors (age, sex, tobacco, alcohol etc.) and potentials associated factors.      The investigators expect measure of DTF allows identifying patient with severe sepsis or     septic shock with diaphragmatic dysfunction. It would also estimate diaphragmatic dysfunction     frequency with ultrasound measure and warranting its use routinely at the bedside. The     investigators expect that DTF helps to characterize degree of severity of septic patient and     can be a new index able to predict intubation in this population.   "
61946|NCT02474745|"     The objective of this randomized clinical trial is to assess and compare the effectiveness of     directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs. directed     open-glottis pushing (pushing during a prolonged exhalation) during the second stage of     labor. The study hypothesis is that open-glottis pushing results in better maternal and     neonatal outcomes, in particular for maternal pelvic floor and continence function.   "
61947|NCT02474732|"     FDA requires that the user's guide be provided with any over-the-counter (OTC) medical     device. It is beneficial to demonstrate that the user's guide for a new medical device is     broadly comprehensible where the device will be provided without prescription and direct     physician counseling. Therefore, a population of subjects will be tested to determine whether     they can properly use the BeActive Brace device after reading the user's guide.   "
61948|NCT02474719|"     The aim of this study is to demonstrate the efficiency of an adapted and alternate     peritoneal dialysis scheme in terms of sodium extraction and purification compared to an     adapted conventional peritoneal dialysis scheme.   "
61962|NCT02474537|"     This is a phase I, multi-center, open-label, single oral dose, parallel group study to     evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired     hepatic function and non-cancer subjects with normal hepatic function.The study population     will be healthy male and postmenopausal or sterile female subjects who meet all of the     inclusion and none of the exclusion criteria. Subjects will be assigned to groups according     to their hepatic function: normal (Group 1), mild (Group 2), moderate (Group 3), and severe     (Group 4) impairment. This study consists of a two-staged design with interim analysis. In     Stage 1, subjects in Groups 1, 2 and 3 will be enrolled. Upon completion of Stage 1, an     interim analysis will be conducted. Depending on the results of the analysis, either the     study will conclude with no further enrollment or Stage 2 will commence with enrollment of     Group 4.      A minimum of 6 evaluable subjects per group will be enrolled.Once enrolled in the study,     participants will be confined to the facility for 4 days, given a single dose of INC280 and     monitored for pharmacokinetic and safety assessments.   "
61949|NCT02474706|"     Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing     Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and     cross-transmission in healthcare establishments. These give rise to major problems in     standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to     the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is     very frequently observed. The current therapeutic strategy involves the use of a carbapenem,     which represents the last effective solution on an individual level. However, the growing use     thereof is contributing, collectively, to the development of resistance due to the production     of carbapenemases, which will become a major public health problem, with a potential     therapeutic dead-end. This observation is particularly worrying due to the very small number     of antibiotic agents currently in development.      Infectious disease specialists and microbiologists are thus examining alternative agents to     carbapenems in the management of infections caused by ESBL-producing E. coli. One of the     avenues which could be developed is the use of known agents, already on the market, which are     active in vitro on ESBL-producing E. coli, but which are not currently recommended for this     indication in standard practice due to the lack of conclusive studies. Cefoxitin, an     antibiotic belonging to the cephamycin group, could thus represent an alternative of     particular interest in the treatment of infections caused by ESBL-producing E. coli, and help     limit the use of carbapenems.      The implementation of a prospective, randomized, non-inferiority study on ertapenem and     cefoxitin is of the most interest from a methodological perspective. It will enable     recommendations to be drawn up, with a high level of evidence, very long-awaited in the     field.      Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus     imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused     by ESBL-producing E. coli susceptible in vitro to cefoxitin.      Secondary objectives:        -  To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment          of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E.          coli susceptible in vitro to cefoxitin.        -  To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant          bacteria in the gut flora.   "
61950|NCT02474693|"     The Centers for Disease Control and Prevention conducted an observational cross-sectional     study to obtain information about the amount of sodium consumed from various sources     (including sodium from processed and restaurant foods, sodium inherent in foods, and salt     added at the table and during cooking) and to examine variability across population     subgroups. Data collection will include an observational component as well as a sub-study     designed to refine the accuracy of estimates of total sodium intake and discretionary sodium     intake.      Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul,     Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a     study center in each location recruited 150 participants (total N=450). Overall, an     approximately equal number of adults ages 18-74 years by approximately 10-year age groups in     each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was     conducted among a subgroup of 150 of these participants (50 per site). University of     Minnesota serves as a study coordinating center.   "
61951|NCT02474680|"     This is a non-randomized, single-case design of pharmacogenetic implementation in a mental     health patient population of subjects taking antipsychotics and/or antidepressants.   "
61973|NCT02474394|"     This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and     Macintosh laryngoscope on intraocular pressure during laryngoscopy.   "
62440|NCT02468323|"     This study aims to compare the quality of perioperative antiemesis of palonosetron and     ondansetron in patients undergoing cesarean section   "
61955|NCT02474628|"     Intervention studies do not account for high within-individual variation potentially     compromising the magnitude of an effect. Repeat administration of a treatment allows     quantification of individual responses and determination of the consistency of responses. The     investigators aim to determine the consistency of metabolic and exercise responses following     repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active     males will complete six cycling capacity tests at 110% of maximum power output (CCT110%)     following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials).     Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise,     post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise     outcome.   "
61956|NCT02474615|"     Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions     were selected to participate in this study. The lesions were diagnosed with cone-beam     computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In     patients with two teeth to be treated, a tooth was retroobturado with PBEA cement,     (experiment) and another tooth was retroobturado with MTA cement (control).      There was significance for the two cements on the repair of wounds. Key words: Apicoectomy;     Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research   "
61957|NCT02474602|"     The effects of phototherapy has been widely studied by some research groups. The     investigators know that there are positive results with light application to improve muscle     performance and delay fatigue. However, there are few studies showing its´ effects on     muscular training. Therefore, the aim of this study was to assess the effects of phototherapy     applied at different times during 12 weeks of strength training. For such, 48 volunteers,     healthy male, from 18 to 35 years old were recruited to perform a strength training protocol     for the anterior muscle of the thigh development. Volunteers performed the training protocol     twice a week for 12 weeks. There were assessed isometric peak torque in isokinetic     dynamometer, 1-repetition maximum test in the leg extension and leg press machines and     bilateral thigh perimetry.   "
61958|NCT02474589|"     Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and     tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.   "
61959|NCT02474576|"     The efficiency of percutaneous aponeurotomy in the treatment of Dupyutrens disease is well     known. However, the duration of the clinical improvement after aponeurotomy is not well     known.      This study aims primarily at measuring the incidence rate of local relapse of     Dupuytrens-induced finger flessum, within two years following treatment by percutaneous     aponeurotomy in Dupuytrens.   "
61960|NCT02474563|"     The purpose of this study is to assess the 2-year progression-free survival rate.   "
61963|NCT02474524|"     This project is a component of a broader research program referred to as Self-Management and     Recovery Technology (SMART): Use of online technology to promote self-management and recovery     in people with psychosis, which has been funded by the Victorian Department of Health Mental     Illness Research Fund (MIRF33). The overall research program is examining the therapeutic     potential of using online (Internet-based) educational and multimedia resources in mental     health services. It involves the development of a website which can be accessed via an     internet browser on a desktop computer, tablet computer, or smartphone. It consists of a     series of educational modules containing textual information, exercises, audio, and video     clips designed to promote self-management and recovery in people with a history of persisting     mental illness.      This particular project (SMART-Therapy) involves a randomised controlled trial examining the     use of a discrete 8-session psychosocial intervention delivered in addition to routine care     which utilises these online materials. The intervention will involve a mental health worker     meeting with the participant with a tablet computer (e.g. iPad) on which online materials can     be viewed, and used to guide an interaction with the participant.      The randomised controlled trial will include 148 participants, who will be randomised to     receive one of two interventions: (a) meeting with a support worker using the SMART website     to guide interaction (health intervention), or (b) meeting with a support worker delivering a     social interaction-based control condition (social intervention). In each condition, there     will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed     pre-randomisation, and at 3, 6 and 9 months.      The primary hypothesis is that participants randomised to the health intervention will show     greater improvement in personal recovery than participants randomised to the social     intervention, and that these improvements will be maintained at follow-up (6 and 9 months     following intake).   "
61964|NCT02474511|"     The purpose of this study was to investigate whether general anesthesia will affect the     postoperative recurrence and metastasis of malignant tumor.   "
61965|NCT02474498|"     To clinically evaluate the treatment of mandibular class II furcation defects with enamel     matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium     phosphate/hydroxyapatite (βTCP/HA).   "
61966|NCT02474485|"     AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to     evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting     bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon     Sequent Please®.   "
61967|NCT02474472|"     The primary objective of the study is to compare the efficacy of standard local anesthetic     bupivicaine and liposomal bupivicaine in postoperative pain control both in magnitude and     duration in patients undergoing sternotomy, thoracotomy, thoracoabdominal, and laparotomy     incisions.   "
61968|NCT02474459|"     The purpose of this study is to test the use of a clinical decision support tool for     postoperative care of Parkinson's disease patients who are treated using deep brain     stimulation (DBS). The central hypothesis is that the use of a DBS clinical decision support     system for individual patient management will enable considerable time savings and reduced     burden on patients and caregivers.   "
61969|NCT02474446|"     The investigators want to make sure that people get the right dose of Vitamin D treatment.     They will therefore investigate how skin colour, body mass index, ethnicity, vitamin D     binding protein and genetic variation affect the response to a standard course of vitamin D     in young adults, as a prelude to further studies in younger children.   "
61970|NCT02474433|"     This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several     hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal).     Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time     required to achieve dilatation and patient preference.   "
61971|NCT02474420|"     This is a randomized, open label, two arms superiority trial of a representative population     of patients with a primary diagnosis of transfusion dependent thalassemia with evidence of     moderate cardiac iron overload, defined as an average T2* MRI parameter at the mid     inter-ventricular septum between 10 and 20ms.   "
61972|NCT02474407|"     This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability study     involving adolescents and adults with refractory (drug-resistant) epilepsy   "
61974|NCT02474381|"     The vascular pathologic basis of diabetic foot include arterial obstruction and     micro-circulation defects.The latest technology of arterial reconstruction can only rebuild     blood flow of anterior,posterior tibial artery and peroneal artery.Endothelial progenitor     cells have been proved to integrate into damaged vascular endothelium and improve     vasculogenesis in vitro and in animal experiment.Therefore endothelial progenitor cells are     supposed to improve the micro-circulation status of diabetic foot patients.In this trial,the     investigators recuit diabetic foot patients with infrapopliteal arterial obstructive     disease,treat them with autologous endothelial progenitor cells after intraluminal     intervention,and observe the therapeutic efficacy comparing to single intraluminal     intervention.   "
61975|NCT02474368|"     This research study seeks to gain new knowledge about the addition of a carefully targeted     boost dose of radiation as a possible treatment for recurrent or metastatic head or neck     cancer. The name of the study intervention involved in this study is stereotactic body     radiotherapy, which is a way of delivering radiation in a more precisely targeted way and     with a higher dose than conventional radiotherapy.   "
61977|NCT02474342|"     The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue     Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.   "
61987|NCT02474212|"     To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in postoperative     cardiac surgery patients by comparing plasma anti-Xa activity when enoxaparin is administered     either as a continuous intravenous infusion or subcutaneous bolus once daily.      After informed consent, 80 elective on pump CABG patients with a clinical indication for     post-operative thromboprophylaxis will be studied in the Tampere University Hospital Heart     Central. The study will consist of two independent parts. In the first part of the study     twenty elective CABG patients will be randomised to receive subcutaneous enoxaparin     (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days. Another     twenty patients will be randomised to receive the same dose of enoxaparin (40 mg) daily as     continuous intravenous infusion for three days (72 hours). In the second part of the study     twenty elective CABG patients will be randomised to receive subcutaneous enoxaparin     (Klexane®, Sanofi-Aventis) 0,5 mg/ kg twice a day. Another twenty patients will be randomised     to receive enoxaparin 1 mg/kg daily as continuous intravenous infusion for three days (72     hours).   "
61978|NCT02474329|"     Background: Long-term management of Parkinson's disease (PD) does not reach its full     potential due to lack of knowledge about disease progression. The Real-PD study aim to     evaluate the feasibility and compliance of usage of wearable sensors in PD patients in real     life. Moreover, an explorative analysis concerning activity level, medication intake and mood     will be done.      Methods: Overall, 1000 PD patients and 250 physiotherapist will be enrolled in this     observational study. Dutch PD patients will be recruited across the country and an assessment     will be performed using a short version of the Parkinson's Progression Markers Initiative     (PPMI) protocol. Moreover, participants will wear a set of medical devices (Pebble     Smartwatch, fall detector) and they will use a smartphone with The Fox Insight App (Android     app), 24/7, during 13 weeks. Primary measures of interest are: 1) physical activity, falls     and tremor, measured by the axial accelerometers embedded in the Pebble watch and fall     detector; and 2) medication intake and mood reports measured by patients' self-report in the     Android app. To measure motor impact, an assessment will be performed by physiotherapists who     are all Unified Parkinson's disease rating scale - (MDS-UPDRS) certified.      Discussion: Management of PD patients is complex and appears to be a challenging task for     health care professionals. The main reason is the lack of knowledge in the disease pattern.     This issue could be solved by a long term follow-up of patients' during their everyday life,     and wearable medical devices can act as a way to collect data about every day life     activities. Therefore, the Real-PD study will be a first contribution in increasing the lack     of knowledge in disease progression, developing a new medical decision system and improving     PD patients' care.   "
61979|NCT02474316|"     This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA     treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative,     will be randomized (1:1) into 2 study arms as follows:      Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg     qd for 48 weeks   "
61980|NCT02474303|"     Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities to     rethink HIV prevention and treatment strategies, especially for key populations such as     Female Sex Workers (FSWs). Antiretroviral (ARV)-based prevention of HIV transmission has the     potential to have a profound population-level impact on the course of the HIV/AIDS pandemic.     Several recently completed randomized controlled trials of HIV Pre-exposure Prophylaxis     (PrEP) have shown efficacy at reducing HIV acquisition in high-risk populations. How to     translate these trial results into population-level effects is the next critical step. PrEP     demonstration projects, in collaboration with local stakeholders and at sites of routine     care for high-risk populations provide an opportunity to move promising research results into     actual public health benefits. With these key features in mind, the investigators propose a     HIV PrEP demonstration project in FSW in Dakar, Senegal, West Africa. The objective of the     proposed demonstration project with Tenofovir DF/Emtricitabine (TDF/FTC) among Female Sex     Workers (FSW) in Dakar Senegal is to build a sustainable HIV PrEP program for FSW in Dakar,     Senegal while demonstrating the feasibility of providing daily oral PrEP with Truvada     (TDF/FTC) for 12 months to the enrolled FSW at Ministry of Heath run clinics (IHS, and     Pikine, Mbao, Rufisque and Diamniadio Health Centers). Critical milestones for this     demonstration project with be feasibility, uptake, acceptability, use of TDF/FTC PrEP and     programmatic retention of FSWs in Dakar MoH clinics. The investigators have assembled an     expert team from RARS,The University of Washington, and Westat that have had greater than 2     decades of collaboration on HIV related projects in FSWs in Senegal. The investigators expect     the results of this project will show that Senegal provides a unique opportunity to assess     acceptability, feasibility, uptake and effectiveness of oral HIV PrEP at reducing HIV     transmission in a high-risk FSW population.   "
61981|NCT02474290|"     The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of     leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD     positive acute myeloid leukemia (AML).   "
61982|NCT02474277|"     The aims are to identify predictive indicators of hospitalized elderly medical patients' need     for rehabilitation and to validate (known group validity) the Chair Stand Test   "
61983|NCT02474264|"     This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to     comparing the endothelial function of male BRCA mutation carriers with that of age matched     non-BRCA mutation carriers.   "
62026|NCT02473705|"     The purpose of this research study is to study the effect of fish oil and bicarbonate (baking     soda) on exercise. In this study fish oil, bicarbonate or both will be compared to placebo to     see if study participants increase exercise capacity.   "
61984|NCT02474251|"     The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta     (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the     mechanisms involved are not well understood. Recent studies support the hypothesis that Aβ     dynamics in the brain are influenced by the sleep-wake cycle, with increases in the     production of soluble Aβ during wakefulness and decreases during non-rapid eye movement     (NREM) sleep, and more specifically on NREM stage 3 (also called slow wave sleep [SWS]).     These changes produce a consistent diurnal pattern in the cerebrospinal fluid (CSF) that has     been documented in murine models and in humans. By better understanding this sleep-wake     relationship the investigators hope to identify how sleep disorders accelerate the     progression of AD in the elderly (which has been demonstrated by multiple epidemiological     studies) and, in turn, identify novel therapeutic targets for AD prevention.      The purpose of this study is to elucidate how soluble amyloid beta (Aβ) levels in the brain     are influenced by the sleep-wake cycle in humans, and to test the directionality of this     relationship through sleep disruption experiments. The investigators will test two models.     The first model will test how, prior to amyloid deposition, brain soluble Aβ levels may be     relatively increased in the elderly by two mechanisms: a) loss of total sleep time and SWS     that occur with normal aging; and b) sleep disturbances such as Sleep Disordered Breathing     (SDB) or insomnia that are common in late life (Aim 1). The second model will test how     stage-specific sleep disruption may lead to increased CSF Aβ42 levels (Aim 2). A group of     adults with diagnosed severe SDB and good continuous positive airway pressure (CPAP)     compliance will be used to test this model sleep deprivation experiments using therapeutic     CPAP vs. sham CPAP.      This project will be the first to explore the protective effect of SWS on Aβ42 dynamics in a     group of cognitively normal elderly subjects as well as the effect of acute sleep disruption     by CPAP withdrawal on CSF Aβ42 levels in a well characterized clinical sample of severe     obstructive SDB patients on treatment with CPAP. The results from this study will improve our     understanding of the nature of the Aβ diurnal pattern and the brain consequences of full     night sleep disruptions as well as sleep disruptions during specific stages of sleep.   "
61985|NCT02474238|"     No single type of laser or set of laser parameters is appropriate for all type of irides.     Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as     the gold standard for iridotomy. It, however, is less effective and causes some complication     such as iris hemorrhage especially in patients with dark iris.   "
61986|NCT02474225|"     The introduction of additional fluid into the vitreous cavity by intravitreal therapy would     be expected to cause an immediate rise in the intraocular pressure. This transient,     short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal     anti-vascular endothelial growth factor therapy has been well describe. The investigators aim     to study the prevalence of the sustained intraocular pressure elevation associated with     intravitreal injection of anti-vascular endothelial growth factor agents.   "
61988|NCT02474199|"     This research study is for liver transplant recipients and their respective living donors.      The purpose of this study is:        1. To see if it is safe for liver recipients to receive one dose of donor reactive T          regulatory cells (Tregs)        2. To see if the Tregs allows a liver recipient to take less, or completely stop          medications normally taken after receiving an organ transplant.   "
61990|NCT02474173|"     This phase Ib trial studies the side effects and best dose onalespib when given together with     paclitaxel in treating patients with triple negative breast cancer that has spread to other     places in the body and usually cannot be cured or controlled with treatment (advanced).     Onalespib works by blocking proper processing of proteins that are important for cancer     growth. This results in inability of these proteins to work properly. Paclitaxel kills breast     cancer cells by interfering with their ability to divide. Giving onalespib together with     paclitaxel may be better in treating patients with breast cancer.   "
61991|NCT02474160|"     This research trial collects and stores tissue and blood samples from patients with cancer.     Collecting and storing samples of tissue and blood from patients with cancer to study in the     laboratory may help scientists create new and better models to learn about cancer and to test     new cancer drugs.   "
61992|NCT02474147|"     The purpose of this study is to        1. Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian          sandwich) in response to the postprandial period by using functional brain imaging of          reward circuitry implicated in food motivation and energy balance in patients with type          2 diabetes (T2D), obese subjects and healthy controls.        2. Characterize some of the pathophysiological mechanisms of action of different meals in          obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA,          IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)   "
61993|NCT02474134|"     The purpose of this study is to compare the safety, tolerability, and blood levels of two     interferon beta-1b products, Betaferon and PF530, in healthy volunteers.   "
61994|NCT02474121|"     This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat     subjects with critical limb ischemia (CLI) caused by severe PAD.   "
61995|NCT02474108|"     This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation     in patients with valvular heart disease and left atrium enlargement   "
61997|NCT02474082|"     This is a randomized, controlled, multicenter, open-label study with blinded assessment of     the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate     to severe plaque type psoriasis who are candidates for systemic therapy. The study consists     of 2 periods: a screening period of at least one week and up to four weeks, and a treatment     period of 24 weeks. During the screening period eligibility of the patients is confirmed.     Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment     arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are     followed up for assessments of the study endpoints until week 24. Patients in treatment arm B     receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and     Fumaderm® will be performed throughout the study and up to week 24.   "
61998|NCT02474069|"     This study is designed to support the optimal use of secukinumab by providing data to refine     guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to     explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients     who had less than almost clear skin at week 16.   "
61999|NCT02474056|"     We hypothesis that in various situation when the effective blood volume decreased the venous     volume flow characteristics change according to the fluid resuscitation   "
62000|NCT02474043|"     The goal of this study is to evaluate the effectiveness of a brief, computerized behavioral     intervention for promoting screening for hepatitis C and reducing risky behavior for people     who inject drugs (PWID).   "
62001|NCT02474030|"     This study was conducted with an aim to know how individual attributes associated to     intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold     associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and     psychological state evaluated by the Profile of Mood States.   "
62002|NCT02474017|"     To confirm the robustness of the CRC749 inhaler.   "
62003|NCT02474004|"     In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the     knee adduction moment (KAM) during walking. Other researches found out that an increase of     the KAM is an important factor contributing to degeneration joint disease of the knee     (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons,     because preserving as much of the meniscus as possible is assumed to delay degenerative joint     disease.      The investigators hypothesize significant differences in knee adduction moments between     patients treated with partial medial meniscectomy vs. patients treated with medial meniscus     repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned     groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis     2) and that the knee adduction moment correlates with the clinical outcome as determined by a     typical knee score (hypothesis 3).   "
62004|NCT02473991|"     The aim of this prospective longitudinal study was to investigate the relationship between     placental thickness during the second and third trimesters and placental and birth weights.   "
62005|NCT02473978|"     In this study the investigator would like to examine hemodynamic cerebral blood flow and     brain function by the use of Invos cerebral oximetry in women undergoing cesarean section     delivery.      This study is a purely observational study, it will not have any clinical intervention nor     will it interfere with standard cesarean delivery protocols in any way.      The investigator's primary objective is to evaluate how anesthesia influences cerebral blood     flow perfusion during cesarean section deliveries.   "
62006|NCT02473965|"     This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the     efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified     (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia     Gravis (MG).   "
62007|NCT02473952|"     The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to     placebo in subjects with MG.   "
62010|NCT02473913|"     The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk     thistle) in children and adults with trichotillomania. The hypothesis to be tested is that     silymarin will be more effective and well tolerated in children and adults with     trichotillomania compared to placebo. The proposed study will provide needed data on the     treatment of a disabling disorder that currently lacks a clearly effective treatment.   "
62011|NCT02473900|"     The purpose of this study is to investigate the bioequivalence after administration of     HIP1403 and HGP0919 in healthy male volunteers   "
62012|NCT02473887|"     The purpose of this study is to give children with gastroenteritis with persistent vomiting     flavored intravenous ondansetron orally. The investigators test the palatability of the drug     and check the serum level of ondansetron at 4 hours .   "
62013|NCT02473874|"     The purpose of this study is to obtain skin spectroscopic data from two imaging systems.      Comparison groups:        -  Skin Spect dermoscope        -  Spatially modulated quantitative spectrometer   "
62014|NCT02473861|"     This study is a randomized control cross over trial of exercise training during or after     taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage     I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise     training for 8-12 weeks. The immediate exercise group will exercise during taxane     chemotherapy and the delayed group will start exercise 2 weeks after completion of treatment.     This design will allow for an assessment of the effects of exercise vs usual care during     treatment, plus a comparison of the training response during vs. after chemotherapy.   "
62015|NCT02473848|"     The substance ingenol mebutate (IM) is registered in Switzerland and many countries worldwide     for the treatment of actinic keratosis (AK). There is no data on the use of IM in organ     transplant recipients, a population highly affected by AK and skin cancer at large. The     investigators want to study the use of IM against AK in this high-risk group of patients and     assess its safety. The investigators are hoping to prove that IM is safe to use in AK of     organ transplant recipients, allowing its use in the clinical routine treatement of AK also     in this subset of patients with AK.   "
62016|NCT02473835|"     Overweight and obesity are major problems and their complications such as cardiovascular     disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is     accumulating evidence to support obesity being a chronic inflammatory disorder mediated in     part by the expansion of adipose (fat) tissue.      In addition to adipocytes (fat cells), adipose tissue contains a whole range of other cell     types including some immune (white blood) cells. The relative proportions of immune cell     subpopulations and interactions between the different cell types within adipose tissue may be     important in the development of type 2 diabetes.      Previous research by the investigators has suggested that there may be important differences     in the activation status of certain immune cells located in adipose tissue with increased     overweight and the production of leptin - an appetite regulating hormone. Properties of     adipose tissue and inflammatory cells located within it may therefore be sensitive to changes     in our nutritional status.      The purpose of the present study is to investigate changes in T cell activation in adipose     tissue alongside other immunometabolic properties before and after a short period of dieting     compared to changes in blood.      Participants will include males aged between 35-55 years old who meet the criteria for     inclusion. After taking some preliminary measurements and monitoring of normal daily     activities, participants will reduce their calorie intake to 50 % of their normal     intake/requirements for 3 consecutive days and will attend 1 session of Laboratory testing     before and 1 after this period which will take place in the Physiology Laboratories at the     University of Bath.      It is hoped that investigating immunometabolic responses within adipose tissue following an     acute nutritional challenge will help lead to a better understanding of the development of     diseases associated with being overweight and ultimately help in the development of more     effective methods for prevention and treatment.   "
62017|NCT02473822|"     This is a non-interventional study to retrospectively validate the technical use TLS (Tape     Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the     validity of the technique and its positive influence on the resumption of sporting activities     in relation to the existing literature.   "
62018|NCT02473809|"     The purpose of this study is to test whether liraglutide, a drug approved and widely used in     the treatment of type 2 diabetes, has an effect on bone mass and bone cell function. Type 2     diabetes may cause multiple complications, and it is well known that patients with type 2     diabetes have a higher risk of fractures. If Liraglutide can be demonstrated to have a     positive effect on bone, this may be one among other factors to consider before the decision     about specific treatment of type 2 diabetes is made for the individual patient.   "
62039|NCT02473536|"     Stereotactic Ablative Radiation Therapy (SABR): 5 fractions of 8 Gy or 3 fractions of 12Gy     fro kidney tumor and tumor thrombus   "
68837|NCT02384759|"     This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for     strategic studies evaluating the usefulness of including targeted therapeutics from the first     line with aflibercept +/- LV5FU2.   "
62019|NCT02473796|"     Melghat is poorly developed tribal area in India with very high child mortality &     malnutrition prevalence (grossly inadequate medical facilities). Important health problems.     Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W.     babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home     Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate     (IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region.      Melghat.      Need of project :      Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the     research:. The results obtained in this area will be applicable for reducing children     mortality and malnutrition in other parts of Melghat and all other tribal areas of India.      Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI,     Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing     government ICDS and health system.      Melghat.      Need of project :      Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the     research:. The results obtained in this area will be applicable for reducing children     mortality and malnutrition in other parts of Melghat and all other tribal areas of India.      Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria     clinically & Neonatal care) in 19 villages.   "
62020|NCT02473783|"     Objectives:        1. To evaluate the relationship between improvement of Hamilton Depression Rating Scale          (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD          subjects being treated with Sertraline HCl        2. To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for          assisting in detecting MDD        3. To evaluate the relationship between basal HAMD score and basal SERT availability for          MDD subjects        4. To evaluate the relationship between basal HAMD somatic subscale score and basal SERT          availability for MDD subjects        5. To evaluate the relationship between change of SERT availability and change of HAMD          score for MDD patients being treated with Sertraline HCl   "
62044|NCT02473471|"     The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the     miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and     pain's interference, the level of satisfaction and comfort using this protocol. Finally root     resorption associate with this technique will be evaluated.   "
62021|NCT02473770|"     Background:      - Disasters like earthquakes, floods, and oil spills can give people health problems. Workers     who respond to a disaster (like police and firefighters) are directly exposed to contaminants     during the emergency response. So they could be at the greatest risk for these problems.     Researchers want to gather data about these workers before and right after they go to a     disaster. They hope this will help them understand the health effects of disasters.      Objectives:      - To answer questions about the health effects of disaster exposures. To create a participant     registry and collect biological samples and health data.      Eligibility:      - People at least 21 years of age who are sent to a disaster area for an emergency response.      Design:        -  Participants will have 1 study visit.        -  Participants will answer questions about:        -  Contact information        -  Health, lifestyle, emotions        -  Medical history        -  Disaster response activities        -  Things they are exposed to in the environment        -  Participants may have blood collected from a vein in the arm.        -  Participants may give biological samples. These may be urine, saliva, cheek cells, nail          clippings, or hair.        -  Participants will have a short physical exam. They may have their hip and waist measured          over their clothes. The amount of oxygen in their blood may be measured by a sensor on a          finger or ear.        -  Participants may have a lung function test. They will take a deep breath and exhale          strongly.        -  Participants will be asked to agree to be contacted later to update contact data and          learn about future studies.   "
62022|NCT02473757|"     Background:      - Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely     by regulators because there can be long-term, unexpected side effects. NIH is required to try     to contact people who have been treated with gene therapy at least annually for up to 15     years. This is to see if they have had any bad side effects. This trial does not include any     therapy and is only for patients previously treated on gene-therapy trials at the NCI     Experimental Transplantation an Immunology Branch who are no longer enrolled on their     original gene therapy clinical trial.      Objective:      - To collect of long-term follow-up data on people who have been in gene transfer studies.     This follow-up is required by regulators.      Eligibility:      - People age 18 and older who have been in a previous NCI Experimental Transplantation and     Immunology Branch gene therapy research study.      Design:        -  After they get the genetically modified cells, participants will:        -  Have blood drawn 3, 6, and 12 months later.        -  Have an annual clinic visit for the next 4 years. They will have a physical exam. They          will answer questions about any signs of neurological, autoimmune, or blood disorders,          or any new cancers. Blood <TAB>may be drawn.        -  Be called or emailed annually for the next 10 years. They will answer health questions.          Blood samples may need to be taken.        -  Participants will be asked for their current address and phone number. They will also be          asked for the address and phone number of 1 or 2 people who will know their whereabouts.          One of these should be a family member if possible,        -  At the time of the participant s death, researchers will request permission from their          family for an autopsy.   "
62023|NCT02473744|"     -  Background : Edema of lower extremities is a concern ranging from 19 % to 60% of          palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily          activities, esthetic and behavior. Usual treatment is based on diuretics and          physiotherapy but is often unsuccessful. In case of conventional treatment failure, in          palliative care, subcutaneous drainage can be discussed with the patients. The technique          is simple, easy to use but remains off the record. Since 2004, 23 cases were reported          with various methods. All the cases reported were undertaken with various technical          approaches and efficacy criteria.        -  Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is          effective in case of refractory lymphedema of the lower limbs in palliative care and          leads to an improvement in QOL in terms of behavioral and autonomy.   "
62024|NCT02473731|"     The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck     cancer patients and to explore downstream molecular pathways to identify tumor response and     resistance mechanisms by evaluating various biomarkers before and after treatment.   "
62027|NCT02473692|"     The present research will pilot-test a new state-of-the-art Internet-based intervention     targeting adherence facilitation and optimization of medication use, and will be evaluated to     assess its utility in facilitating adherence and optimization of medication use for acute     migraine pharmacotherapy. This is not an interventional study and will instead be an     observational assessment of the feasibility of an online program (a proof-of-concept study).     The two principal objectives of this study include: (a) examination of the feasibility and     user usage patterns of an Internet-based intervention designed to potentially enhance     adherence to medication use recommendations, and (b) determination of the efficacy of the     Internet-based intervention in potentially increasing knowledge of abortive medication-use     guidelines and in improving adherence to those guidelines. To meet the objectives of this     study, a website has been specifically developed including a series of supplemental     text-based headache materials and a series of videos based social learning theory and     modeling principles (as opposed to the stereotypical 'talking-heads' mode of information     delivery).   "
62042|NCT02473497|"     This is an open label expanded access protocol for the treatment of up to approximately 40     adult or pediatric (defined as age <18 years) patients with tumors harboring either a     chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an     activating genetic alteration involving the cMET gene who cannot swallow the crizotinib     capsule but may be able to derive benefit from treatment with an alternative oral formulation     of crizotinib.   "
62028|NCT02473679|"     Cardiac arrest occurs frequently and the outcome after out-of-hospital resuscitation is often     fatal. Disturbing is that more than half of the surviving patients suffer from permanent     impairment of cognitive functions, such attention, memory and executive functioning. With all     the efforts to achieve a high quality initial resuscitation management the time delay between     cardiac arrest and the beginning the initial resuscitation maneuver is the main reason for     the still poor outcome. To shorten this fatal time delay, current efforts of national and     supranational health authorities aime at the non-medically trained lay person, who should     carry out basic life support directly on the scene supported by the use of public available     semi-automatic defibrillators (AED).   "
62029|NCT02473666|"     Study the influence of transfusion related Patient Blood Management Program actions on     transfusion-related outcome measures and cost.   "
62030|NCT02473653|"     Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies     try to assist a patient's immune system (a system in our bodies that protects us against     infection) in killing tumors. One form of such therapy is the dendritic cell combined with     HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are     immune cells that can tell your immune system to fight infection. In laboratory testing,     these cells may also help the immune system attack tumors such as breast, kidney cancer or     skin cancer. The purpose of this research study is to determine if it is both possible and     safe to administer this vaccine to patients with any HER2+ cancer.   "
62031|NCT02473640|"     A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect     of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a     Functioning Ileostomy   "
62032|NCT02473627|"     This is an open-label, cross-over, fixed-sequence study. All subjects will receive the same     treatment in two study periods. The study is designed to test whether DS-1971a has any effect     on the activity of various enzymes involved in the metabolism of medicines, using test     medications. These will be given without and then with DS-1971a to see if DS-1971a has any     effect on the blood levels of the test medicines.   "
62033|NCT02473614|"     We are trying to determine the therapeutic effect of the music glove and conventional hand     exercise program to patients with spinal cord injuries. All participants will be randomized     into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with a     minimal 3 hours exercise time per week. Participants will receive the other intervention at     their 3 week post therapy follow up visits. Clinical evaluations will be performed at     baseline 1 and 2 (3 to 10 days apart), post therapy after first intervention, 3-week post     therapy follow up, post therapy after second intervention, and 3-week post second     intervention follow up visits.   "
62034|NCT02473601|"     Observed the muscle relaxation of mivacurium in patients with liver cirrhosis.Clear of     mivacurium in patients with liver cirrhosis without muscle relaxant accumulation and delayed     recovery phenomenon   "
62035|NCT02473588|"     A group of engineers at Michigan State developed a novel waveform analysis technique (Long     Time Interval Analysis [LTIA]) that attempts to estimate cardiac output non-invasively.     Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest     acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares     LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.   "
62036|NCT02473575|"     The purpose of this study is to determine whether caffeine gum improves the performance of     runners completing free timed mass participation 5 km runs in the United Kingdom (UK)   "
62037|NCT02473562|"     The effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive     daytime sleepiness in Parkinson's disease will be studied in a randomized, double blind,     placebo-controlled clinical trial with a within-subject crossover design.   "
62038|NCT02473549|"     Many individuals are often left with problems moving their arm and hand, months to even years     after a stroke. Recent progress in research suggests the application of non-invasive brain     stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with     rehabilitation exercises can further improve a person's ability to move after stroke.     However, the problem is that this doesn't work for everyone, and researchers do not know why.     One reason may be that TDCS is currently applied using a one-size-fits-all approach.     Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in     the same way. But, researchers know this is not the case. For example, each person will     likely have different amounts of damage to brain regions that control movements. A better     understanding of how the stroke uniquely affects a person's brain will help us to know which     is the correct type of TDCS to apply for that person. Therefore, the objective of this     research is to determine whether the amount of damage to brain regions that control movements     can predict which type of TDCS will be more effective to help a person improve their ability     to move. Participants will undergo 1 session of magnetic resonance imaging, and three     sessions of TDCS.   "
62040|NCT02473523|"     Researchers at St. Jude Children's Research Hospital want to investigate the feasibility of a     yoga intervention for adolescents receiving treatment for lymphoma or leukemia. Adolescents     who participate in the program may experience improved physical and psychosocial measures.     Improvements in these areas may increase participation in meaningful activity and improve     quality of life.      Adolescents diagnosed with cancer may experience more fatigue, anxiety and pain during     treatment. Yoga is considered a complementary alternative medicine (CAM) that has been     implemented into some pediatric oncology rehabilitation programs and has been shown to be     beneficial in both inpatient and outpatient settings. It may decrease anxiety and increase     quality of life and hamstring flexibility in teens.      PRIMARY OBJECTIVE:        -  To determine the feasibility of yoga intervention for adolescents during lymphoma and          leukemia treatment.      OTHER PRE-SPECIFIED OBJECTIVE:        -  To obtain pilot data regarding efficacy of yoga on pain, quality of life, fatigue and          physical performance.   "
62041|NCT02473510|"     This prospective annual release study is designed to evaluate the safety of 3 new influenza     virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza     season   "
62086|NCT02472925|"     This is a 3-arm, multi-center, patient-randomized, field evaluation of the Way to Cure     behavioral interventions on medication adherence in HCV.   "
62045|NCT02473458|"     Stroke is one of the most important causes of mortality and disability both in developed and     developing countries. The only food and drug administration (FDA) approved therapy for acute     stroke is recombinant tissue plasminogen activator (rtPA). But narrow therapeutic window has     limited the usefulness of thrombolytic therapy. Therefore, finding effective neuroprotective     drugs for the patients for whom thrombolysis is contraindicated or not feasible seemed to be     mandatory in the world of cerebrovascular medicine.      Licorice, extracted from root of a plant scientifically known as Glycyrrhiza glabra, is used     in food industries. Certain medical properties has been contributed to licorice and     specifically to its active chemical components such as flavonoids and glycyrrhizic acid (GA).     GA has been revealed to assert its anti-inflammatory effect by suppression of NF-κB, a key     component of lipopolysaccharide-induced inflammatory response. Neuroprotective     characteristics of GA has been widely investigated in recent studies.      In the present study, the investigators verified the efficacy and safety of oral     administration of two different doses licorice extract in the patients with acute ischemic     stroke, in a double-blind randomized controlled trial.   "
62046|NCT02473445|"     A long-term extension study of patients with mitochondrial diseases, who are ≥ 6 years old     and < 18 years previously enrolled into the RP103-MITO-001 (NCT02023866) study assessing the     safety, tolerability and efficacy of RP103.   "
62047|NCT02473432|"     This study, part of a larger research project (The Retornus Study), is aimed to evaluate new     strategies to optimize rehabilitation outcomes in dysphagic stroke patients. Main objective     is to assess effectiveness of neuromuscular electroestimulation (NMES) in combination with     respiratory muscle training (RMT) in the treatment of oropharyngeal dysphagia in subacute     stroke patients.   "
62048|NCT02473419|"     The objective of this research is to use functional magnetic resonance imaging (fMRI) with a     neuropsychological task to test the prefrontal mechanism of action of the medical food     Vayarin.   "
62049|NCT02473406|"     Infected pancreatic necrosis and its related septic complications are the major cause of     death in patients with acute pancreatitis, therefore prevention of pancreatic infection is of     great clinical value in the treatment of AP.      Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced     CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic     infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its     effects in preventing pancreatic infection was not well studied. To evaluate the effects of     TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical     outcomes in patients with AP,we aimed to design this study.   "
62050|NCT02473393|"     To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial     Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.   "
62051|NCT02473380|"     Intraoperative surgical fluorescence microscopy is a useful technique for the surgical     resection of glioma. However the accuracy of this method is limited by its too low     sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current     limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a     pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure     two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which     clearly enables to distinguish the solid component of glioblastomas from low grade gliomas     and infiltrative component of glioblastomas. This innovative method could become in future a     useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post     resection to check for residual dysplasia) and real-time assessment of resections margins     during surgery. However, those preliminary ex-vivo results have to be confirmed in a     feasibility in-vivo study on human.   "
62052|NCT02473367|"     In order to define the safe windows for co-dosing of metal-cation antacids with once daily     administered raltegravir, this study will evaluate the effect of both calcium carbonate and     magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage     of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice     daily as part of their HIV treatment regimen.   "
62053|NCT02473354|"     Purpose of the Study: (1) To classify an individual subject's ventilatory response in terms     of respiratory depression to a bolus of remifentanil under normoxic and hyperoxic conditions.     (2) Measurement of specific respiratory parameters to predict the opioid-induced respiratory     depression (OIRD) response.   "
62060|NCT02473263|"     The purpose of this study is to determine whether an aggressive strategy of severe sepsis     patients since pre hospital care, including early antibiotics administration, hemodynamic     optimization, and opotherapy when indicated, could reduce mortality   "
62061|NCT02473250|"     This study is for subjects with a diagnosis of bipolar disorder who have depression at the     time of recruitment. It involves brain imaging with an MRI (magnetic resonance imaging) and     PET scan (positron emission tomography) and treatment with an antidepressant. The medication     involves adding an SSRI (either celexa/citalopram or prozac/fluoxetine) to a mood stabilizer.   "
62054|NCT02473341|"     Severe Alcoholic hepatitis, defined by modified Maddrey's Discriminant Function (DF) ≥32, is     associated with significant morbidity and mortality.(1,2) Of the various treatment modalities     evaluated for treatment of Severe Alcoholic hepatitis, corticosteroids have been the most     extensively studied.(1) Five out of 13 randomized controlled trials, and four out of 5     meta-analysis have shown a survival benefit with corticosteroids, especially in patients with     DF ≥32 and/ or encephalopathy.(1-4) However, the role of corticosteroids in Severe Alcoholic     hepatitis still remains controversial.(5-6) Corticosteroid therapy is not considered the     ideal option by most authors because their beneficial effect seems to be confined to a highly     select minority group in which the inhibitory effect of corticosteroids on liver inflammation     is not outweighed by side effects such as weakened defence against infections, anti-anabolic     effects, and possible ulcer promoting effects.(6) Corticosteroids are usually contraindicated     in those with DF > 54 or MELD >24 (7) .Also corticosteroids are contraindicated in those with     renal failure, gastro-intestinal bleed, pancreatitis and active sepsis. Therefore, there have     been constant efforts to evaluate new therapies for Severe Alcoholic hepatitis (SAH). In a     recent trial, combination of glucocorticoids plus N-acetylcysteine was found to improve one     month survival in patients with Severe Alcoholic hepatitis, compared with glucocorticoids     alone. However, the 6 month survival similar in both the groups.(8) Human colostrum and     bovine colostrum are rich in protein, immunoglobulin, lactoferrin and growth factors. Recent     studies suggest that colostrum components, immunoglobulin and growth factor benefits     physically active person as well as in the treatment of autoimmune disorders. It is used for     the treatment of a wide variety of gastrointestinal conditions, including non-steroidal     anti-inflammatory drug-induced gut injury, Helicobacter pylori infection, immune deficiency     related diarrhea as well as infective diarrhea.(9,10,11) It has also been sucessfully used to     significantly decrease the level of Endotoxemia - lower levels of Lipopolysaccharides.      We plan to compare the efficacy of bovine colostrum versus Placebo (Pasteurized milk powder)     alone in treatment of severe alcoholic hepatitis. Bovine Colostrum is rich in protein,     immunoglobulin, lactoferrin and growth factors. Recent studies suggest that Colostrum     components, immunoglobulin and growth factor benefits physically active person and in     treatment of autoimmune disorders. It is used for the treatment of a wide variety of     gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut     injury, H pylori infection, immune deficiency related diarrhea as well as infective     diarrhea.(9) The guidelines by American College of Gastroenterology (10) and other authors     (11) have suggested that a combination of Corticosteroids and other drugs, which have     different mechanisms of action, may be more beneficial for reducing mortality in severe     alcoholic hepatitis. Hence, the investigators plan to compare the efficacy of combined     therapy of Corticosteroids and Bovine colostrum versus Corticosteroids alone in treatment of     severe alcoholic hepatitis.   "
62087|NCT02472912|"     Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability     of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous     Injection in Healthy Adults.   "
62088|NCT02472899|"     The study aims to identify immune biomarkers in peripheral blood for identifying Alzheimer's     disease (AD). Blood samples from subjects with AD will be compared to age-matched controls     without cognitive symptoms, as well as healthy younger subjects.   "
62055|NCT02473328|"     The goal of antiretroviral therapy should be maintaining undetectable plasma viral load, only     present condition to prevent the progression of the disease, improve immune restoration and     prevent the emergence of viral resistance mutations. In addition to the individual benefit,     antiretroviral treatment reduces the transmission of HIV from an infected person to sexual     partners. There is to date no alternative strategy to antiretroviral treatment and     antiretroviral therapy, even extended, does not allow viral eradication.      The need to maintain antiretroviral therapy for life raises the long-term safety concerns of     it, even with the latest molecules. Also, one of the key issues in clinical research is     whether after reaching undetectable viral load, antiretroviral treatment can be reduced in     order to reduce exposure to molecules. Indeed, this treatment of maintenance could     potentially need a smaller antiviral potency. On the other hand, reduction of antiretroviral     treatment reduces costs, an important consideration in light of new global recommendations of     treatment for all patients with T-cells CD4 below 500 / mm3.      The alleviation of antiretroviral therapy is to either reduce the number of molecules by     making monotherapies or dual therapy, or to realize or intermittent treatment is to reduce     the doses of molecules such as randomized ENCORE -1 showing the equivalence of a dose of     Efavirenz 400mg instead of 600mg in naive patients.      Atalow study has the sense to lower the dose of Atazanavir / Ritonavir in combination with     two NRTI to reduce exposure to this molecule and its cost while maintaining an undetectable     viral load.   "
62056|NCT02473315|"     Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition     at a temperature of approximately -110 degrees.      A considerable increase in the popularity of WBC has occurred in rheumatologic patients,     despite a lack of evidences of its efficiency.      Because of its interesting anti-inflammatory properties, the investigators think that WBC     could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs)     and corticosteroids, in patients suffering from axial spondyloarthritis.      This is a proof of concept study.   "
62057|NCT02473302|"     Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in     Western country.      The main risk factors associated with colorectal cancer depend of lifestyle, and processed     meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound     linked to lipid peroxidation and nitrosation.      The aim of this study is to study the impact of the daily consumption of beef, processed or     not, on lipid peroxidation induced heme iron ; and to study the impact of the daily     consumption of ham, processed or not, on the nitrosilation induced heme iron.   "
62058|NCT02473289|"     The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to     antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50     milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week     double-blind treatment period) is compared to adjunctive placebo based on the change from     baseline to 12-week endpoint in depressive symptoms as measured by the total score on the     Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive     Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant     therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) >=0.300 milligram     per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects     with hsCRP <0.300 milligram per deciliter will also be enrolled to allow a better     understanding of the relationship between CRP and clinical changes.   "
62059|NCT02473276|"     Neuraxial analgesia (most commonly continuous epidural or combined spinal epidural) is the     most effective modality available for pain relief during labor. Accidental dural puncture     (ADP) with a large bore epidural needle and the resulting post-dural puncture headache (PDPH)     is one of the most significant sources of anesthesia-related morbidity in parturients.      Epidural blood patch (EBP) is the gold standard for treatment of PDPH, and although almost     always effective, can result in another ADP, as well as low back pain and lower extremity     pain. For this reason, effective measures to prevent PDPH when ADP occurs would be highly     valuable. One small study in which 50 women were randomly allocated to receive 2 epidural     injections of morphine or saline, demonstrated a beneficial effect of epidural morphine in     decreasing the incidence of PDPH.      This study aims to determine the efficacy of 2 doses of neuraxial (either epidural (EPID) or     intrathecal) preservative-free morphine (PFM) to prevent headache after ADP in parturients.   "
62062|NCT02473237|"     Chronic Obstructive Pulmonary Disease (COPD) secondary to biomass exposure constitutes a     chronic respiratory condition frequently excluded from large clinical trials. Biomass     exposure COPD have some histopathologic, clinical, radiological and functional differences     with tobacco smoke COPD. However, until now, there are no evidence in this patients about the     clinical response to bronchodilators routinely used in tobacco smoke COPD.      Primary objective: To compare changes in walked meters from baseline on six minute walking     test (6MWT) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with     moderate to severe COPD secondary to biomass exposure.      Secondary objectives: To compare changes in pulmonary function (inspiratory capacity, Forced     Expiratory Volume in first second (FEV1) milliliters, FEV1 through) from baseline (-10     minutes) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate     to severe COPD secondary to biomass exposure.      This will be an open label study, double blinded, cross over and conducted at specialized     respiratory care center (National Institute of Respiratory Diseases), to compare the acute     effects of ultra long acting bronchodilators used in tobacco smoke exposure COPD. Unicentric     study.      Ethics Committee approbation: C 22-12   "
62089|NCT02472886|"     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and     tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without     ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.   "
62063|NCT02473224|"     This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4),     placebo-controlled safety, illness, and infection study of a new experimental human challenge     stock of the Norovirus genogroup II, genotype 2 (GII.2) isolate designated Snow Mountain     virus (SMV). The study duration is 24 - 36 months. The primary objectives are to: 1) evaluate     the safety and reactogenicity of the GII.2 Snow Mountain norovirus challenge stock and 2)     determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve     illness in a high proportion (= / > 75%) of subjects.   "
62064|NCT02473211|"     For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is     a burning need for the development of pan-oral interferon-free regimen. The investigators     examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and     daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis     patients with chronic G1b infection.   "
62065|NCT02473198|"     The main objective of the study is to determine if intrarticular injection with liposomal     bupivicaine (Exparel) provides better postoperative pain relief and functional outcome     following total knee replacement (TKR) than the current standard New England Baptist Hospital     regimen of femoral nerve block combined with intraarticular injection of a standard     bupivicaine solution.   "
62066|NCT02473185|"     Aim: The purpose of the study is to examine the effects of medication, placebo and     expectation on objective and self-rated performance of ADHD core signs during the Quantified     Behavior Test in patients with untreated ADHD.      Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric     investigation at the Dependence Clinic Västmanland, Västerås, Sweden.      Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The     study is taken place during four hours on two investigating days, separated by a 4 days     wash-out period.      All patients participate on two occasions: In one session they receive the Methylphenidate     (MPH) condition, and in the other session they receive the placebo condition. MPH and placebo     conditions are counterbalanced across subjects such that half of the participants receive MPH     first, and the other half of the participants receive placebo first. Neither the participant     nor the research assistant is aware when the participant receive the MPH condition or the     placebo condition.      On each investigating day the participant accomplish Questionnaires (Visual Analogical     Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise, (d)     perceived help from the pill and (e) self-rated symptoms. In addition the participant     completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test     Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective information     regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity measured with     the camera, and inattention and impulsivity on basis of the CPT-test.      The Quantized Behavior Test (QbTest) can be included as part of an neuropsychiatric     investigation. QbTest measures the three core signs of ADHD, hyperactivity, inattention and     impulsivity. QbTest is a computer-based test that combines a test of attention ability with a     movement analysis based on an infrared measurement system. The test results are presented in     a report and compared with norm data fromm a group of the same sex amd age who do not have     ADHD.   "
62067|NCT02473172|"     This study evaluates the impact of the assisted mode of mechanical ventilation on diaphragm     efficiency in mechanically ventilated critically ill patients. Participants will be     randomized to the neurally adjusted ventilatory assist (NAVA) mode or to the pressure support     ventilation (PSV) mode.   "
62068|NCT02473159|"     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer     localization.      In this study, our hypothesis are as following:        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure          better outcome.        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.   "
62069|NCT02473146|"     Purpose : The main objective of this study is to assess the efficacy and tolerance of the     addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition     with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de     novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for     efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates,     cumulative incidence of relapse and overall survival. The secondary endpoints for safety are     early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse     events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by     covariate interactions with respect to biological characteristics present at diagnosis (CD33     positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual     disease levels). This study is an exploratory study. Patients will be allocated at inclusion     with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and     cytarabine in a 3+7 regimen similar to the backbone ALFA 1200 scheme used concurrently by     the ALFA group as treatment of AML patients aged >60 years.      Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab     ozogamicin (GO) during induction and one dose of GO during first consolidation in combination     with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.   "
62082|NCT02472977|"     The purpose of this study is to determine whether the combination of Ulocuplumab and     Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung     cancer.   "
69022|NCT02382341|"     The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as     measured by CT scans. Patients' improvement in pain and function will also be followed     through various outcome measures.   "
62070|NCT02473133|"     In patients with locally advanced stage III non-small cell lung cancer, the probability of     local control remains low (about 17% at 1 year). Concomitant radio-chemotherapy is the     standard treatment. An increase in total radiotherapy dose (from 66 to 74 Gray) has been     proposed to improve local control, with contradictory results.      Relevant FDG-PET scan images can be acquired during radio-chemotherapy, with a demonstrated     prognostic impact and recently in a multicentre prospective study. A significant reduction in     FDG uptake / volume (metabolic response) suggests that the radiotherapy target volume could     be reduced during radiotherapy possibly improving organs at risk tolerance. Conversely, a     lack of metabolic response may justify treatment intensification before the end of     radiotherapy. The investigators hypothesis is to investigate the individual tumour     heterogeneity on FDG-PET during radio-chemotherapy to reduce the volume to a biological     target that could receive a higher total dose (personalized dose redistribution).   "
62071|NCT02473120|"     The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in     patient with metastatic breast cancer.   "
62090|NCT02472873|"     The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during     laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard     cystectomy treatment - a prospective case control study.   "
62306|NCT02470065|"     This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early     stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and     ARM B: immediate surgery with curative intent.   "
62072|NCT02473107|"     The present study aims to evaluate the impact of detecting active initial caries lesions in     primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and     satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary     dentition will be examined and treated in a mobile dental unit, which will temporarily be     parked in public schools of Sao Paulo. The caries detection will be conducted using the     International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an     adjunct criterion for caries activity assessment. Children will be randomized in two groups     according to the caries threshold to be detected: Group A (only advanced lesions will be     detected and treated, independently of their activity status) and Group B (all caries     lesions, including initial ones, will be detected and all active lesions will be treated).     After this, the treatment plan for each child will be made according to strategies mentioned     above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction     of children and quality of life will be collected after diagnosis, after the end of treatment     and 12 and 24 months from the initial examination. For comparison between groups, multilevel     regression analyses will be performed. The primary outcome will be sites which need of     operative treatment during the follow-up periods and the secondary outcomes will be the     cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the     impact on quality of life.   "
62073|NCT02473094|"     A phase II, randomized study of placebo versus metformin in association to chemotherapy with     capecitabine and radiation in the neoadjuvant treatment of locally advanced (T3-4N0M0 or     TxN1-2M0) rectal carcinomas.   "
62074|NCT02473081|"     The purpose of this study is to determine whether the telephone-delivered Minimal     Psychological Intervention (MPI) could improve diabetes' depressive symptom and     diabetes-related immediately , as well as HbA1c level in the long-term.   "
62075|NCT02473068|"     Patients who are suffering from a variety of respiratory conditions benefit from continuous     positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some     patients find the temperature of the breathing gas difficult to tolerate. The aim of this     study is to compare comfort of healthy volunteer participants while being given CPAP at     different temperatures.   "
62076|NCT02473055|"     90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest)     group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3     hours, then fed, then KC group was placed in KC and control group remained in incubator for a     2-3 hr test period. EEG measures of sleep, HR, and RR were taken. .   "
62077|NCT02473042|"     The goal of this clinical research study is to learn if light electrical stimulation to the     wrist area during surgery is feasible in women having breast surgery.   "
62078|NCT02473029|"     The study aims at measuring the sensitivity and specificity of a series of imaging signs     (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular     ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis     of Horton disease, the gold standard being the result of temporal artery biopsy.   "
62079|NCT02473016|"     A placebo-controlled, single-blind study to evaluate the safety and preliminary efficacy of     nasal carbon dioxide for the symptomatic treatment of classical trigeminal neuralgia.   "
62080|NCT02473003|"     Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality     of life negatively. There is limited knowledge about the physical mechanisms that cause     fatigue, and there is no medical treatment. Physical activity can reduce the inconvenience,     but the investigators need to learn more about the type and intensity of exercise that works     the best as well as how to motivate patients to exercise. The overall aim, is to evaluate the     efficacy and cost-effectiveness of individually tailored high (H) and low/medium (LM)     intensity physical training, with or without behavioural medicine (BM) support strategies,     during adjuvant oncological treatment on; Cancer Related Fatigue (CRF),Quality of Life (QoL),     mood disturbance, adherence to the cancer treatment, adverse effects, disease outcome, return     to a daily life after completed treatment and return to work. The investigators will also     describe changes in inflammatory markers and cytokines related to physical training and gene     expressions following training to investigate whether these serve as mediators for the     effects of physical training on CRF and QoL. This will be evaluated in newly diagnosed     breast, colorectal and prostate cancer patients during adjuvant therapy at three different     centres in Sweden; Uppsala, Lund/Malmö and Linköping. A 2x2 factorial design will be used,     600 patients will be randomised to H, H+BM, LM or LM+BM. Patients will train two times per     week during 6 months. This project will give; new knowledge about aspects for individuals to     gain improved well-being and quality of life, facilitated return to work, and possibly     reduced risk of cancer recurrence. This in turn would result in lower burden on the health     care system, reduced societal costs and have a positive impact on public health.     Implementation of the results into clinical practice will be facilitated by the close     collaboration between researchers and clinicians, and the fact that the study is performed in     clinical settings.   "
62081|NCT02472990|"     The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a     pejorative event. Biomechanical and morphological unknowledge about the loss of the walk     ability in children with DMD is an obstacle in reeducative, pharmacological or surgical     therapeutic targets.   "
62084|NCT02472951|"     Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The     investigators hypothesize that a lower carbohydrate content in the diabetic diet than the     recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic     factors like incretin hormones and decrease their insulinotropic effects due to their glucose     dependency. This will reduce postprandial insulin concentration, resulting in an improved     insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic,     prediabetic and healthy subjects the acute effects of short term highly controlled dietary     low carbohydrate intervention on metabolic pathways with respect to insulin action,     pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in     plasma and novel measures of fatty acid metabolism.   "
62085|NCT02472938|"     The primary objective of the study is to assess the early efficacy of treatment with BG00012     (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and     naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary     objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID     over 24 weeks and to evaluate the safety of BG00012.   "
62092|NCT02472847|"     The goal of the current proposal is to investigate the effects of a cannabinoid drug on the     memory of extinguished fear in humans and the brain circuitry important for the recall of     extinction learning. The investigators findings will translate previous discoveries from     animal studies to humans and increase their understanding of the neurobiological mechanisms     supporting retention of extinction memory. This proof-of-concept study is a critical     translational first step towards the development of cannabinoid modulators as an adjunctive     strategy to exposure-based therapies to augment extinction learning and prevent the return of     fear memories in patients with post-traumatic stress and other anxiety disorders.   "
62093|NCT02472834|"     Patients with end stage renal disease (ESRD) usually have high levels of urea that may     interact with blood proteins and change their structure by a process known as carbamylation.     Evidence suggests that high levels of carbamylated proteins may be linked to adverse outcomes     in dialysis patients. This is a randomized, open-label study to evaluate the effects of amino     acid supplementation on levels of carbamylated proteins in ESRD patients. Secondary     objectives will be to determine whether this intervention can modify intermediate markers of     inflammation, cardiac stress, and erythropoietin responsiveness in this population. Sixty     ESRD patients on dialysis will be randomized into two groups of 30 patients each. Group 1     will receive intravenous supplementation with an FDA-approved amino acid solution (250 mL of     NephrAmine®, 5.4% amino acids) during regular dialysis sessions (3 times weekly for 8 weeks);     Group 2 will be treated according to standard-of-care (no amino acid supplementation). During     the 8 weeks of therapy and for 4 weeks of follow-up, blood will be drawn from patients'     existing hemodialysis access ports (~20 mL once per month) to measure levels of carbamylated     albumin, amino acids, selected biomarkers, and standard laboratory values. Patients     randomized to Group 1 will have fluid volume equivalent to the amino acid therapy removed by     ultra-filtration to avoid net fluid gain. All patients will be monitored for safety (adverse     events) and for changes in hemodynamics and dialysis prescription.   "
62094|NCT02472821|"     Farm and rural youth have frequent exposure to hazardous noise on the farm and     recreationally, and have an increased prevalence of noise-induced hearing loss (NIHL). There     is a lack of programs to prepare this high-risk population to use hearing conservation     strategies. This randomly-controlled trial of innovative community-based interventions is     designed to compare effectiveness and sustainability of approaches to increase youths' use of     hearing conservation strategies. Consistent use of hearing conservation strategies is     expected to reduce rates of NIHL and other negative effects of high noise exposure, and     improve quality of life in this high-risk and underserved group.   "
62095|NCT02472808|"     This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus     the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are     combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite     examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients     visiting our hospital for evaluation of mediastinal lymphadenopathy.   "
62096|NCT02472795|"     International trial to evaluate the biological activity and safety of ACT-334441 in lupus     patients.   "
62097|NCT02472782|"     This is a study aiming to investigate a possible correlation between the parameters affecting     the physicians' therapeutic choice with the patients' overall adherence to osteoporosis     treatment. Secondary end-points include correlation between the parameters affecting the     physicians' therapeutic choice and the patients' quality of life as well as the evaluation of     the whole osteoporosis treatment approach of orthopedic surgeons in Greece (diagnostic means,     use of diagnostic and treatment guidelines, methodology of follow - up).   "
62098|NCT02472769|"     Two different dose levels will be evaluated in two different birth weight categories,     compared to placebo with regards to safety and tolerability.   "
62099|NCT02472756|"     This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously     treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible     participants with FL will receive 6-8 infusions of induction standard regimen of rituximab     plus chemotherapy. Participants with complete or partial remission at end of induction will     be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2     years or until relapse. The choice of the treatment regimen will be established on a per     center basis, according to the standard in use in the country and in the center, and each     center will use the same regimen through the study. Participants will be followed up for     safety and efficacy evaluation in accordance with routine practice.   "
62100|NCT02472743|"     Digital (finger) ulcers are common in patients with systemic sclerosis (SSc) and causes much     pain and affects how patients use their hands. Our current treatments for digital ulcers are     often not effective and have may have significant side effects (because they increase blood     flow to the ulcer to try and help healing).      Light-based treatment has been successfully used to treat chronic diabetic, pressure and     venous ulcers. The investigators wish to investigate whether light-based treatment is a safe     and effective treatment for digital ulcers in patients with SSc.   "
62101|NCT02472730|"     The purpose of this study is to identify if performing diagnostic colonoscopy with a small     plastic cap attached to the camera will improve performance of colonoscopies by physician     trainees.   "
62114|NCT02472561|"     The purpose of this study is to understand the effects that a three month lifestyle-based     mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on     improving physical activity, fitness, important PAD risk factors and quality of life (QOL) in     patients with PAD.      By testing a novel mHealth intervention focused on lifestyle modification, this trial will     address a critical evidence gap in the care of PAD patients. PAD patients are not eligible     for cardiac rehabilitation and therefore struggle with unhealthy lifestyles, and these     patients currently have no lifestyle-based care strategies to help them. The results of this     study have the potential to lead to new sustainable and resource-efficient, lifestyle-based     preventive care strategies for patients with stable PAD.   "
62103|NCT02472704|"     Patients with lymphocytic enteritis (LE), HLA-DQ2/8+, negative celiac serology and clinical     and histological response to a gluten-free diet (GFD) do not fulfil the diagnostic criteria     of coeliac disease (CoD). At present it remains unclear whether they suffer from coeliac     gluten sensitivity (CGS) or non-coeliac gluten sensitivity (NCGS). There are specific tissue     markers of CoD such as anti-transglutaminase deposits (tTG) and intraepithelial lymphocytes     expressing T-cell receptor (TCR) gamma/delta+.      Aim: To demonstrate the existence of CGS in these patients despite having negative celiac     serology.      Methods: Double-blind randomized clinical trial of gluten vs placebo rechallenge for 6 months     in patients with LE on a GFD. Inclusion criteria: >18 years, initial presentation with GI     symptoms, HLA-DQ2/8+, negative celiac serology, good clinical and histological response to     GFD. Patients were randomised to gluten (20 g/day) and placebo (maltrodextrin) (identical     powder sachets mixed with meals). Clinical symptoms were analysed using visual analogue     scales. Quality of life (GIQLI), adherence to diet, serology, and histological changes     including gamma/delta+ IEL and tTG deposits were evaluated.   "
62104|NCT02472691|"     This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate     the safety and feasibility of the addition of Lenalidomide (investigational drug) to the     standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for     relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow blasts,     formerly RAEB-T) after allo-SCT. The starting dose of Lenalidomid is 2.5 mg per day for 21     days with a 7 day rest. The study incorporates 2 interim safety analyses after 10 and 20     patients in order to find the optimal and safe dose of Lenalidomide.   "
62105|NCT02472678|"     Patients with a neuroendocrine tumor (NET) frequently suffer from physical as well as     psychosocial complaints. Patients may experience various symptoms from tumor burden and     secreted hormones by the tumor. They also can have complaints due to their anti-cancer     treatment and accompanying side effects.      Adequate information is an essential aspect of supportive care. Patients need for information     and care remain frequently unnoticed. The aim of the current study is to test the     effectiveness of a web-based tailored information and support system to support patients'     information and care needs. Key features of this website are patient self-screening of     physical and psychosocial problems, tailored patient education on reported problems and     self-referral to professional health care. The investigators expect that the website is a     highly suitable medium to provide tailored information and support.   "
62106|NCT02472665|"     Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with     severe Von Willebrand Disease (VWD).   "
62107|NCT02472652|"     Sexual dysfunction is highly prevalent in schizophrenic patients, affecting up to 80% of men     and women. Antipsychotic induced sexual side effects may be a barrier to treatment     compliance. Antipsychotics such as Risperdal Consta and Invega Sustenna are known to have     higher rates of causing prolactin elevations that may be implicated in sexual dysfunction.     The basic premise of this study is to identify patients who believe they have experienced     sexual dysfunction on Risperdal Consta or Invega Sustenna and switch to the alternative long     acting injectable antipsychotic, Abilify Maintena which tends to lower prolactin levels.     Measures of sexual sexual functioning using the self rated 5 item Arizona Sexual Experience     Scale (ASEX) as the primary outcome measure will be made over a 3 month period to determine     if such a switch is helpful.   "
62108|NCT02472639|"     The purpose of this study is to evaluate patient satisfaction and quality of life in patients     with ileostomy managed with or without the novel Ostom-i Alert device.   "
62109|NCT02472626|"     This phase I/II trial studies the side effects and the best dose of     6,8-bis(benzylthio)octanoic acid (CPI-613) when given together with cytarabine and     daunorubicin hydrochloride and to see how well it works in treating older patients with newly     diagnosed acute myeloid leukemia. CPI-613 may kill tumor cells by turning off mitochondria     (small structures in the cancer cells that are found in the cytoplasm [fluid that surrounds     the cell nucleus]). Mitochondria are used by cancer cells to produce energy and are the     building blocks needed to make more tumor cells. By shutting off mitochondria, CPI-613 may     deprive the cancer cells of energy and other supplies that they need to survive and grow.     Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving CPI-613 together with     cytarabine and daunorubicin hydrochloride may kill more cancer cells.   "
62110|NCT02472613|"     This is a multicentre, single Blind ,randomized controlled clinical trial in ischemic     post-stroke depression patients.The participants will be allocated randomly in either of the     two groups: verum acupuncture plus placebo medication group or sham acupuncture plus true     medication group. On the hypothesis that acupuncture intervention could produce the same     therapeutic effects as antidepressants. The investigators also hypothesized that acupuncture     would be associated with minimal side effects.   "
62111|NCT02472600|"     This investigator initiated,international, multicenter open-label, randomized controlled     trial aims to assess whether a 5 day course of oral nonabsorbable antibiotics (colistin     sulfate 2 million IU per os 4x/day and neomycin sulfate 500 mg (salt) per os 4x/day )     followed by fecal microbiota transplantation (administered either via nasogastric     administration or via capsules) is effective at eradicating intestinal carriage of     beta-lactamase producing Enterobacteriaceae (ESBL-E) and carbapenemase producing     Enterobacteriaceae (CPE). compared to no intervention (current standard of care) in adult     non-immunosuppressed patients .   "
69023|NCT02382328|"     The main purpose of this study is to determine the effectiveness of use Alpha lipoic acid     before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial.   "
62118|NCT02472509|"     It is well established that hemolytic diseases predispose patients to the development of     pigment gallstones. Gallstones are noted in at least 5% of children under the age of 10     years, increasing to 40-50% in the second to fifth decades. The co-inheritance of Gilbert's     syndrome increases the risk of cholelithiasis four to five-fold.      In patients with chronic hemolysis, total bile lipid concentration is decreased and the total     bilirubin to total lipid ratio is increased. This suggests that the conjugating capacity of     hepatocytes is surpassed by the excessive amount of bilirubin resulting from hemolysis.     Increased bilirubin monoconjugate and unconjugated bilirubin can precipitate in bile and form     complexes with inorganic ions, mostly calcium, and develop into stones.      Patients with hemolytic disorders can also develop biliary sludge, a suspension of     precipitated particulate matter in bile dispersed in a viscous, mucin-rich liquid phase . The     chemical composition of the precipitates correlates well with the composition of the     associated stone and sludge often stands as a harbinger of future stone development.      There is strong data suggesting a benefit in treating cholelithiasis with UDCA and also in     preventing gallstone development in various high risk scenarios.      There are several proposed mechanisms for the positive effect of UDCA in primary prevention     of pigment stones. Mucoglycoproteins are present in significant amounts in black pigment     stones and contribute to the matrix of gallstones. UDCA suppresses the secretion of protein     and decreases the levels of various proteins in bile . It has also been suggested that     increased colonic bile salt may solubilize unconjugated bilirubin and may prevent calcium     complexing.      There is no published data at present on the role of UDCA in prevention and treatment of     cholelithiasis in hemolytic diseases. The investigators hypothesise that UDCA can be of     benefit to patients with hemolytic disorders in the primary prevention of pigment stones,     possible resolution of biliary sludge and existent stones, and reduction of symptomatic     episodes of cholelithiasis.   "
62119|NCT02472496|"     The Korean Coronary Overlapping Stenting Registry is a multicenter database which includes     percutaneous intervention using drug-eluting stents from cardiovascular centers in eight     affiliated hospitals of The Catholic University of Korea   "
62120|NCT02472483|"     The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy     (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations     and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a     large sample of refractory bipolar I patients on mood stabilizers.   "
62121|NCT02472470|"     Youth depression is a debilitating disorder that exacts enormous social, economic and     personal cost. Unfortunately, treatments which are conventionally used to treat adult     depression have often modest to no efficacy in youth and have side effects. Thus, there is a     tremendous imperative to develop new treatments for youth depression. Investigators propose     to examine the efficacy of a short form of repetitive transcranial magnetic stimulation     (rTMS) for youth depression and examine its biological targets. This will be the first study     examining the efficacy of a short rTMS protocol in youth diagnosed with depression who fail     responding to or are intolerable to antidepressants. If the results are positive,     investigators will have identified a novel treatment that may be both more efficacious,     better tolerated and more acceptable treatment for youth depression. Finally, identifying the     biological mechanisms leading to treatment efficacy will lead to more personalized treatments     for youth depression and will be groundbreaking vis à vis understanding the mechanisms     involved in this illness.   "
62122|NCT02472457|"     Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition     of the gastrointestinal tract with a high risk for complications and need for surgical     interventions, particularly in children. Immunomodulators and biologic therapies are     effective at inducing and maintaining remission in pediatric CD, yet there is no proven     strategy for reducing exposure to medications once sustained remission has been achieved.     Diet has been proven to impact disease activity in CD and may allow for sustained drug-free     remission. The primary objective of this study is to determine whether pediatric CD patients     in long-standing remission remain in remission longer after stopping medications if they     follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED     will have longer time-to-relapse as opposed to those on an unrestricted diet.   "
62123|NCT02472444|"     Taste perception plays an important role in maintaining nutritional balance. Gustatory evoked     potentials (GEP) can be detected in response to an intermittent stimulation of the gustatory     receptors by a primary flavour. GEP are non invaisve, painless and safe.      The aims were to establish a reliable recording of GEP in Humans and to determine     physiological variations of the gustatory evoked cerebral activity, by recording gustatory     evoked potentials in different physiological situations (different intensities of taste     solutions, after feeding or fasting, with different taste...). Healthy volunteers were     included in this study. GEP were recorded in 9 cortical sites by EEG sensors (10/20 system),     in front of the primary and the secondary gustatory cerebral areas, referenced against ear     lobes.   "
62124|NCT02472431|"     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front     abdominal wall. ADRC will be administered one-time intracavernosally. This is a single arm     study with no control. All patients receive cell therapy.   "
62125|NCT02472418|"     Crossover study of DFN15A versus DFN15B versus Placebo in the treatment of migraine     headaches.   "
62126|NCT02472405|"     This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex     laser or no treatment results in a better outcome in the quality of the surgical scar using     the multiplex cynergy laser, starting treatment the day of suture removal.   "
62127|NCT02472392|"     The purpose of this study is to examine the toxicity of using allogeneic stem cell     transplantation for treatment of subjects with relapsed or refractory ES and     rhabdomyosarcoma. This is a nanrandomized two-arm study is designed to determine the safety     and incidence of graft versus host disease (GVHD) in patients with relapsed, refractory     Ewings sarcoma receiving related and unrelated, allogeneic stem cell transplants.   "
62128|NCT02472379|"     UCLA researchers looking for healthy females (age 60+) to participate in a study     investigating how writing about your experiences may be related to your health.      Once a week for 6 weeks, participants will write about their experiences and fill out online     questionnaires. Participants will also come to the UCLA campus for blood draws and to fill     out questionnaires 3 times: once prior to the 6-week writing period, once immediately after     the 6-week period, and once 2-months after the writing period.   "
62129|NCT02472366|"     A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients     insufficiently responsive to available therapies.   "
62130|NCT02472353|"     The goal of this study is to determine if co-administration of metformin and doxorubicin in     breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of     patients who develop a significant change in left ventricle ejection fraction (LVEF).   "
91204|NCT02092285|"     The primary objective of this study is to evaluate the efficacy of golimumab in maintaining a     clinical response in participants with moderate-to-severe ulcerative colitis.   "
62131|NCT02472340|"     In recent years, evidence has shown that mitochondrial dysfunction plays an important role in     the development of age-related muscle decline that may lead to frailty.      During aging, there is a progressive reduction in the cell's capacity to eliminate its     dysfunctional elements by autophagy, as evidenced by the accumulation of oxidative damage and     mutations in mitochondria and by the decrease in autophagic flux. In fact, it has been     demonstrated that dysfunctional mitochondria can be specifically targeted for elimination by     autophagy, a process that has been termed mitophagy.      A major challenge in the clinic today is in the lack of validated tools, including     biomarkers, to assess the decline in mitochondrial health associated with an impairment in     muscle function. In the present study, the investigators will employ a battery of established     and exploratory tests (clinical, physiological and molecular) to assess in vivo mitochondrial     function and more specifically, the levels of mitophagy and autophagy, in the muscle of     healthy and pre-frail elderly.      It is anticipated that the results of this study will facilitate the rapid translation of     interventions targeting mitophagy and autophagy for the improvement of muscle function.   "
62132|NCT02472327|"     Patient satisfaction after an unplanned cesarean section was studied and in the previous     study it was noted that there were common themes that lead to patient dissatisfaction. The     four common themes were: lack of trust regarding the indications for surgery, communication     issues, loss of control, and fear during the situation. The purpose of this second phase of     this study is to try and improve patient dissatisfaction by offering additional emotional     support prior to the c/s with the hope of decreasing the trust issues toward physicians,     decreasing the communication barriers, and decreasing the fear and loss of control. The     additional emotional support that will be received prior to the cesarean section will be     scripted based upon the findings of the investigators' prior study - the patient will be     asked four questions and each question addresses the four themes that were noted in the     previous study.   "
62133|NCT02472314|"     The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into     the shoulder to continues nerve block with Bupivacaine on postoperative pain control and     functional outcomes.   "
62134|NCT02472301|"     To determine if 12 months of legume-based complementary foods is effective in reducing or     reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months     to see if these improvements are correlated with specific changes in the enteric microbiome.   "
62135|NCT02472288|"     This study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for the     post-stroke patients with urinary retention under conventional treatments, compared with sham     electroacupuncture.   "
62136|NCT02472275|"     This phase I trial studies the side effects and best dose of multitargeted tyrosine kinase     inhibitor PLX3397 (PLX3397) when given together with radiation therapy and antihormone     therapy in treating patients with prostate cancer that is at intermediate or high risk of     spreading. Multitargeted tyrosine kinase inhibitor PLX3397 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth, and may also help the radiation     therapy work better. Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens     can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide     acetate, goserelin acetate, or degarelix, may lessen the amount of androgens made by the     body. Giving multitargeted tyrosine kinase inhibitor PLX3397 with radiation therapy and     antihormone therapy may be a better treatment for prostate cancer.   "
62137|NCT02472262|"     To determine if 6 months of legume-based complementary foods is effective in reducing or     reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months     to see if these improvements are correlated with specific changes in the enteric microbiome.   "
62138|NCT02472249|"     Dr Rajan is investigating a new method to improve local treatment of liver cancer. There is     evidence that a drug, norepinephrine (NE), has the ability to shrink down normal liver blood     vessels, but leave tumor vessels wide open. In patients with primary liver cancer, NE will be     injected directly in the artery that nourishes the liver and the tumor. Real time blood flow     will be measured using an advanced CT scanner to demonstrate the NE effect on blood vessels.     If Dr Rajan's hypothesis is confirmed, this drug has great potential to benefit patients     during local delivery of chemotherapy in the liver artery, diverting it away from normal     liver and towards the tumor, resulting in less complications and improved tumor kill.   "
62139|NCT02472236|"     To assess the effect of PEX168 doses on the pharmacokinetics of digoxin in healthy     subjects.To provide a scientific basis for clinical drug combination of PEX168.      To assess the safety of single doses of digoxin administered with and without PEX168   "
62140|NCT02472223|"     The primary aim of this pilot study is to generate data needed to design a definitive trial     to compare the safety and efficacy of standard care with artificial tears vs. Betadine 5% (5%     povidone-iodine) for the treatment of pink eye due to adenovirus. There is currently no FDA     approved treatment for pink eye, a common and highly contagious eye infection caused by     adenovirus. Standard care as recommended by the American Academy of Ophthalmology and     American Optometric Association is instillation of artificial tears to relieve symptoms and     possibly reduce the virus population. Betadine 5% is a commercially available, broad-spectrum     antiseptic ophthalmic solution used for over 50 years to prepare the patient's eye and     surrounding area for eye surgery. Because Betadine 5% kills bacteria and viruses, it may be     useful in treating adenoviral conjunctivitis. Betadine 5% is inexpensive, safe, widely     available, and immune to the development of bacterial/viral resistance. Betadine 5% has the     potential to significantly impact the clinical management of pink eye worldwide.      This pilot study has received funding from the National Eye Institute. Participants who meet     eligibility criteria will be randomized using a masked randomization packet to receive     one-time, in-office treatment with either artificial tears or Betadine 5%.      Patients who agree to study participation will answer questions about their pink eye     symptoms, medical and ocular history, have an eye examination and be tested to confirm pink     eye due to adenovirus using a FDA approved point of care immunoassay. Participants testing     positive for adenovirus will have a tear sample taken to measure viral load by qPCR.     Randomization and a one-time treatment with either (standard care) artificial tears or     Betadine 5% will be done on the first visit. Follow-up visits are at 1,4,7,14 and 21 days. At     each visit, symptoms of pink eye are asked, a standardized study eye examination is given by     the masked clinician and a sample of tears is taken to assess viral load by qPCR.   "
62163|NCT02471924|"     Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by     a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale     and maternal suffering. It would be interesting to have a tool that could detect patient who     are at risk to have hypotension.This study consist in measuring variations of under aortic     velocity peak (ΔITVAo) which estimate the modification of the cardiac output by Trans     thoraciq echography.   "
68733|NCT02386111|"     This is a study to determine the clinical benefit (how well the drug works), safety, and     tolerability of combining varlilumab and sunitinib. The study will enroll patients with     metastatic clear cell renal cell carcinoma.   "
62141|NCT02472210|"     Most Parkinsonism related pain can be assigned to one or more of five categories:     musculoskeletal pain, neuritic or radicular pain, dystonia associated pain, primary or     central pain, and akathitic discomfort. In PD pain tends to affect the side of the body that     was initially, or more severe affected by the motor symptoms. Botulinum toxins are an     effective treatment modality for a growing number of neurological conditions. They have been     studied for a variety of conditions associated with PD including dystonia, jaw tremor,     apraxia of eyelid opening, camptocormia, dyskinesias, freezing of gait, sialhorrea,     overactive bladder and constipation. There are no studies for the use of Botulinum Toxin for     pain in PD. The investigators will perform a double-blind, randomized cross-over study     evaluating the efficacy and safety of an individual pattern of BTXA injections targeted at     painful muscles vs. placebo injection.   "
62142|NCT02472197|"     Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical     procedure, the intrauterine pathology is resected by a transcervical approach in several     fragments using a mono or bipolar cove after distension of the uterine cavity and by     endoscopic control. The main risks of this surgery are: uterine perforation and OHIA     (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are     new intrauterine devices, recently appeared on the French market.      In comparison to classical resectors, morcellators have several theoretical advantages:        -  A smaller instrument diameter with potentially a lower risk of uterine perforation and          cervical laceration during the dilatation procedure,        -  The use of physiological serum, eliminating the risk of neurological toxicity of          glycine,        -  The risk of electrical accident is canceled (internal or external burns due to leakage          current),        -  A decreased risk of air embolism, due to the absence of bubbles' production,        -  The instrument is always under visual control, the perforation risk by the active          instrument is therefore very limited,        -  The vision is not obscured by the fragments or by the bubbles,        -  The treatment of pre-ostial pathologies, not always easy in classical resections, could          be facilitated,        -  the absence of thermal effect, and therefore a potentially lower endometrial aggression,          is interesting in women with reproductive desire,        -  Absence of chips management, limiting the entry and exit movements in the uterine          cavity, improving the vision, reducing the infectious and traumatic risks, specially          uterine perforation and air embolism,        -  Morcellation could preserve tissues for histological analysis of possible malignancy          (compared to techniques using heat, coagulation, vaporization),        -  Easy learning in comparison to the time-consuming learning of classical hysteroscopic          resection,        -  Generated additional cost could be partly amortized by reducing operating time and          complications.      It seemed useful to study this new technology.      The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps     between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver (Integrated     Bigatti Shaver IBS), Storz®, and a conventional resectoscope.      The secondary purposes were to compare the efficiency, complications and comfort of these     techniques.   "
62143|NCT02472184|"     This study will look at the optimal order in which to perform concurrent office hysteroscopy     and endometrial biopsy in female patients who present for evaluation of abnormal uterine     bleeding at a fibroid and endometriosis treatment center.   "
62144|NCT02472171|"     The overall goal of the research study is to determine whether a high-fat meal causes     postprandial (after meal) inflammation, and whether eating n-3 polyunsaturated fatty acids     (PUFAs) or blueberries that are rich in anti-inflammatory polyphenols suppress the     inflammation in healthy people.   "
62145|NCT02472158|"     The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and     the transparent polyurethane film dressing as coverage of the site of insertion of central     venous catheter, in the evaluation of catheter colonization in critically ill adults     patients.   "
62146|NCT02472145|"     The primary objective of study Part A is to assess the safety of talacotuzumab (formerly     CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with     acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary     objective of study Part B are to assess complete response (CR) rate and overall survival (OS)     in participants with AML who are not eligible for intense induction chemotherapy and who are     randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.   "
62147|NCT02472132|"     Central venous catheter (CVC) is an essential tool in the management of both medical and     surgical patients. Establishing venous access is critically important and is sometimes     technically challenging. Among the many indications for point of care ultrasound (POCUS),     ultrasound-guided venous catheter placement is well described and increasingly used. This     study was designed to evaluate the utility of peri procedural transthoracic echocardiography     (TTE) as a tool for positioning CVC and for ruling out complications.   "
62148|NCT02472119|"     Celiac disease is one of the most common forms of food intolerance (prevalence 1/200). The     disease occurs in genetically predisposed individuals after ingestion of foods containing     gluten. Celiac patients can suffer from severe malabsorption syndrome, mainly characterized     by diarrhea and weight loss. The only therapeutic approach currently recognized is a     life-long gluten-free diet.      Specific regions of gluten molecule become recognizable by lymphocytes and activate them, due     to changes made by tissue transglutaminase. These changes consist in the conversion of     specific residues of glutamine into glutamic acid. The consequence is an increased binding     affinity between gluten and histocompatibility molecule (HLA-DQ2), localized on the surface     of the antigen presenting cells (APC); the exposure of the fragments of modified gluten on     the surface of APC is a phenomenon that eventually activates T lymphocytes.      Recent studies on modified gluten confirmed the hypothesis that it is possible to block the     presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to     those gluten regions responsible for lymphocyte activation.      The enzymatic treatment is performed directly on flour instead of extracted gluten,     maintaining the same anti-inflammatory effectiveness.      The procedure uses a food-grade enzyme, the microbial transglutaminase (mTGasi) isolated from     Streptoverticillium mobarensis, able to catalyze the formation of intermolecular     cross-links that modify the functional properties of the products.      Objective of the study is to validate the ability of the enzyme treatment of wheat flour with     mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients.   "
62149|NCT02472106|"     This study is designed to monitor the safety and performance of the V8 balloon when used as a     postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI)     device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and     is being investigated for an expanded intended use.   "
62150|NCT02472093|"     The aim of the investigators study was to measure reductions in chronic pain in female     patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with     perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized     chronic pain condition that is usually accompanied by fatigue, sleep disturbance and     psychological and cognitive alterations.   "
62164|NCT02471911|"     This study evaluates the addition of selinexor (KPT-330) to RICE chemotherapy in the     treatment of relapsed and refractory aggressive B-Cell Lymphoma, with the goal of improved     response rates (as compared to RICE chemotherapy alone).   "
62151|NCT02472080|"     Radioiodine refractory differentiated thyroid cancer is a rare tumor and therapeutic options     are limited in this setting. Molecular targeted therapies have recently been developed for     progressive disease and demonstrated clinical activity, especially with anti-angiogenic     agents.      For patients with contra-indication to these agents or in case of progression or toxicity     during treatment, chemotherapy is usually proposed but this strategy has not been validated     by prospective data.      The investigators propose to conduct an open single arm phase 2 study to evaluate response     rate according to RECIST 1.1 with GEMOX regimen (gemcitabine - oxaliplatin combination) for     advanced radioiodine refractory differentiated thyroid cancer patients after anti-angiogenic     agents or in case of contra-indication to anti-angiogenic therapy.   "
62152|NCT02472067|"     The main objective of this pilot project is to demonstrate the effectiveness of a     psychologically-based physical therapy (PBPT) intervention for the prevention of disability     in Active Duty Service Members who sustained a musculoskeletal injury (MSI) during deployment     in support of combat operations on a carrier. This intervention is intended to optimize     recovery and restore function in injured Active Duty Service Members.      The three aims necessary to accomplish the main objective are:        1. Demonstrate the feasibility of implementing PBPT on board a carrier;        2. Document and compare risk factors related to disability from MSI aboard two carriers;        3. Demonstrate the effectiveness of the PBPT intervention in a comparative effectiveness          trial   "
62153|NCT02472054|"     The purpose of this project is to study the number of surviving patients until hematopoietic     stem cell transplantation (HSCT) after first line treatment of hemophagocytic     lymphohistiocytosis (HLH) by Alemtuzumab   "
62154|NCT02472041|"     This study evaluates the comparison of two of re-expansion pulmonary physiotherapy in     patients with chest tube. The study group received intermittent positive pressure     intervention and the control group received incentive spirometry intervention associated with     manual operation.   "
62155|NCT02472028|"     The purpose of the study is to test the hypothesis of slowing the progression of White Matter     Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints and a     moderate to high grade of WML on brain MRI.   "
62156|NCT02472015|"     Telemedicine may facilitate adequate treatment of Neuropsychiatric symptoms (NPS) by     identifying underlying causes and tailoring a treatment plan (pharmacological or     non-pharmacologic treatments including provision of staff education and support, training in     problem solving, and targeted therapy directed at the underlying causes for specific     behaviors).   "
62157|NCT02472002|"     MES-HT is a pilot multicenter prospective study conducted in transplant patients who     developed severe coronary vasculopathy. A preparation of autologous mesenchymal cells of bone     marrow is administered by endomyocardial injection, guided by the Noga® cardiac mapping     system.      The main objective is to determine the effect of the administration of autologous mesenchymal     cells of the bone marrow by intramyocardial injection on myocardial perfusion in cardiac     transplant patients with severe coronary vasculopathy.   "
62158|NCT02471989|"     The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides     Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented     refractory GERD on proton pump inhibitor (PPI) therapy.   "
62159|NCT02471976|"     Rationale: Medicalized end of life rose profound society questions and debates. Major Laws     and scientific society recommendations emerged from those reflections. These texts help     withholding/withdrawing life-sustaining treatments allowing a palliative approach and to     favor comfort treatments for end of life patients.      Main Objective: To evaluate the impact of a procedure to support reflection on the level of     therapeutic involvement for surgical patient (who undergone surgery or not) in ICU after     having identified vulnerability criteria early.      Secondary objectives: To assess the usual care of the control group and the impact of the     procedure according to ICU type (medical, surgical, mixed); the characteristics of surgical     patients concerned by a palliative strategy; the impact of an incentive approach on length of     mechanical ventilation and length of stay in the ICU; To measure the extent of information     collected concerning the collegial process; the impact of the procedure on caregivers'     satisfaction; To count the number of identified conflicts Study type: Prospective,     controlled, cluster randomized study of routine care Purpose: Study the implementation of the     Act Leonetti released on 22 April 2005 calling for a compassionate approach and palliative     care for patients at end of life.      Inclusion criteria: Surgical patients (who undergone surgery or not) hospitalized in ICU     during the study period Non-inclusion criteria: Patients hospitalized less than 24h;     non-surgical patients; patients who don't need ICU care or surveillance; minors; brain-dead     patients (at the time of admission) Primary endpoint: Rate of deaths with palliative strategy     (withholding or withdrawing treatments) Randomization process: each center is randomized     adjusting on type of ICU (medical, surgical, mixed) and number of annual hospitalization     volume.        -  Control group: ICU usual care        -  Intervention group: vulnerability criteria lead to reflection on level of therapeutic          involvement, with the help of a written guide.      Number of patients: 2750 surgical patients Number of centers: 45 Study design: usual data     will be collected in a secured web-based Case Report Form (CRF) at ICU admission and each     time therapeutic strategy will change. Additional data will be collected for the intervention     group according to the initial presence or the later apparition of predefined criteria, a     standardized reflection procedure will start helped by the implementation of a guide for     collegial approach and decision making.      Length: 30 months   "
62160|NCT02471963|"     Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse     wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk     factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and     obesity.   "
62161|NCT02471950|"     There is no clinical way of assessing the depth of anaesthesia while patients are on the     heart-lung machine. A new method of measuring the depth of anaesthesia using brainwaves     called the Bispectral index (BIS) has been developed and its use in cardiac surgery is now     widespread. However BIS is also altered by patients body temperature. As cooling is common     during heart surgery the use of BIS to measure the depth of anaesthesia during heart-lung     bypass remains controversial. This study aims to find out what depth of anaesthesia is     produced according to BIS during heart lung bypass using a standard anaesthetic technique     that utilises the anaesthetic isoflurane.   "
62162|NCT02471937|"     Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and     pneumonia in the industrialized world. Early onset (EOD) and late onset (LOD) diseases are     defined in neonates by their occurring within or after the first week of life, respectively.     Molecular epidemiological studies have identified a capsular serotype III clone, referred to     as CC-17 by Multi Locus Sequence Typing, as accounting for the vast majority of neonatal     invasive diseases and for almost all cases of meningitis in LOD.      The investigators working hypothesis is that host-environmental interactions may contribute     to the colonization and persistence of the hypervirulent CC-17 GBS in the neonate. In this     project the investigators will determine if reciprocal interactions between the intestinal     microbiota and the innate and adaptive immune system may specifically facilitate the     colonization of the neonate by the hypervirulent GBS CC-17 clone.   "
62166|NCT02471885|"     Cancer survival has improved steadily due to earlier detection and treatment. Despite the     established efficacy of anthracycline chemotherapy, its damaging effects on the heart     (cardiotoxicity) limits treatment and confers acute and long term adverse cardiovascular     consequences. Protective strategies for the heart (cardioprotection) with iron binders     (chelation), heart rate (beta blockade) and blood pressure (renin angiotensin inhibition)     medications have demonstrated promise in adult cancer patients, but these treatments are     typically prescribed only after significant changes in heart chamber size and pumping ability     are detected by imaging investigations (myocardial dysfunction).      Furthermore, these conventional therapies are constrained by important side effects that     affect bone marrow, blood pressure, and the kidneys.      Remote ischaemic conditioning (RIC) protects the heart by activating cell survival pathways     through brief repeated inflations and deflations of a blood pressure cuff to limit blood flow     temporarily (noninjurious ischaemia). These innate survival mechanisms prevent part of the     cellular injury that occurs during the ischaemia reperfusion cascade during a heart attack     (myocardial infarction). Ischaemia reperfusion injury also shares common biochemical pathways     with anthracycline cardiotoxicity, and thus RIC may be a novel form of nonpharmacological     cardioprotection that can be applied when undergoing anthracycline chemotherapy.      The investigators propose a pilot single centre randomised controlled trial to investigate     the effect of RIC on reducing heart muscle damage (myocardial injury) in     anthracycline-treated cancer patients. The investigators will assess subclinical myocardial     injury using high-sensitivity blood tests (troponin T levels) and advanced imaging     techniques, monitor heart rhythm disturbances (cardiac arrhythmia) and analyse metabolic     changes in urine and blood during chemotherapy, at specified time points, and follow up to 5     years after completing chemotherapy treatment).   "
62167|NCT02471872|"     The BREATHE (Behavioral Research of Environment and Air Pollution Through Education) study is     a pilot randomized control trial comparing the efficacy of a classroom-based intervention to     no intervention in helping middle-school students understand and make behavioral decisions     about air pollution. This study is designed to evaluate the effectiveness of the     classroom-based intervention on knowledge of air pollution, understanding of air pollution     sources, and behavioral choices made to reduce both contributions to air pollution and     personal exposure to air pollution.      It has been well established that pollution is a racial and economic issue. Low-income areas     with populations of predominantly people of color tend to be those with the highest rates of     pollution and the largest particulate exposure. Creation of and exposure to this pollution is     a key issue for the health of inhabitants of these areas, and of those in the broader     surrounding areas. By developing, and assessing the effectiveness of, the investigators hope     that the BREATHE study will give the investigators insights into how to better combat this     higher exposure and reduce the health risks for those in high pollution areas.      The study will take place in 4 visits over a period of 12 months. The hypothesis is that the     classroom-based intervention will be effective in leading to behaviors that will reduce     exposure to air pollution.   "
62168|NCT02471859|"     This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and     Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy     Subjects.   "
62169|NCT02471846|"     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of     GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic     incurable solid malignancy that has progressed after available standard therapy or for which     standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled     in two stages, including a dose-escalation stage and an expansion stage.   "
62170|NCT02471833|"     The purpose of this study is to determine if Telmisartan, an FDA approved blood pressure     medication, may also have beneficial effects on Alzheimer's disease prevention in African     Americans, who are at high risk for Alzheimer's disease.   "
62171|NCT02471820|"     This study is to assess the efficacy and safety of lenalidomide in combination with     adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple     myeloma as well as to collect information regarding the effect of this regimen on     angiogenesis and bone remodeling of the study population.   "
62172|NCT02471807|"     The study is a multi-center, prospective, early feasibility study to measure individual     patient clinical outcomes and effectiveness, evaluate the safety and function, provide     guidance for future clinical study designs and development efforts of the Edwards FORMA     Tricuspid Transcatheter Repair System.   "
62173|NCT02471794|"     The primary aim of this study is to examine the feasibility of implementing an evidence based     patient engagement strategy, known as personalized health planning (PHP), in the context of a     a shared medical appointment (SMA) for individuals with type II diabetes in a primary care     setting.   "
62174|NCT02471781|"     The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory     safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated     for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer     and has an anatomy suitable for repair.   "
62175|NCT02471768|"     Abstract      Objectives:      Primary: To study the association between central aortic blood pressure indices and coronary     artery disease in patients undergoing elective angiography. Secondary: (a) To study whether     any association exists between central aortic pressure indices and the incidence of major     adverse cardiovascular events (MACE) in the same patients during a 6 month follow up period.     (b) To study whether any association exists between the central aortic pressures and     peripheral pressures.      Methods: The investigators conducted a prospective observational study in consecutive     patients undergoing coronary angiography. Central and peripheral pressures were invasively     recorded and coronary artery disease (CAD) classified into obstructive and non-obstructive     group. CAD severity was graded using the Gensini score and subjects were divided into     tertiles. Patients were followed up and the role of central aortic pressure indices in the     prediction of cardiovascular events were analysed.   "
62176|NCT02471755|"     This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT     symptoms.   "
62177|NCT02471742|"     Nipple areolar-complex (NAC) sparing mastectomy, extending the concept of skin-sparing     mastectomy, allows to leave the nipple-areola complex intact and to provide a better cosmetic     result. Large operable T2-T3 breast cancer (BC), treated with neoadjuvant chemotherapy, may     theoretically appear suitable for this surgical option, alternative to conventional     mastectomy or breast conserving surgery in case of unfavorable size of the breast, when a     good response to neoadjuvant chemotherapy has been achieved.   "
62344|NCT02469571|"     Background Sepsis is a common disease leading to high morbidity and mortality. Gut microbiota     and/or gut permeability may play a crucial role in the development of organ dysfunction.      Hypothesis The ingestion of a multispecies probiotic in early sepsis is able to modulate gut     microbiota and/or gut permeability.   "
62178|NCT02471729|"     Management of chronic heart failure (CHF) is a major public health problem. It is associated     with high mortality, frequent hospitalization and represents a large cost to the health care     system. Both pharmacological and non-pharmacological intervention haven't shown to be     effective in reducing morbidity and mortality of these patients when able to modulate the     activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data     have emphasized the potential role of sympathetic renal denervation in patient with     hypertension. CHF per se but even more CHF associated with comorbity lead to significant     increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as     chemo or baroflex abnormalities. These patients usually suffer from conditions which do not     allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with     chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be     exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they     thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic     heart failure affects around 100 million people worldwild imposing a significant burden on     health care system throughout the world. Even though symptoms are improved by heart failure     therapy, they remain significantly disabling for many patients. Chronic over activation of     the sympathetic nervous system is a major component of heart failure and involves efferent     and afferent pathways between brain and many organs. A new therapy directly targeting nerve     traffic-renal artery denervation- has been shown to be effective in drug resistant     hypertension, with an average drop in blood pressure of 33/12 mm hg.      The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct     a study in 12 patients with chronic systolic heart failure undergoing bilateral renal     denervation with an intensive protocol of observation and assessment compring a 3 day     hospital stay post procedure 3 and 6 months of regular outpatient follow-up.   "
62179|NCT02471716|"     This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of FPA008 in     PVNS/dt-TGCT patients. Patients will be enrolled into either Phase 1 (dose escalation) or     Phase 2 (dose expansion) of the study, but not both.   "
62180|NCT02471703|"     This is a prospective, consecutive series, multicenter clinical study of clinical outcomes     following total hip arthroplasty with the SMF stem.   "
62181|NCT02471690|"     The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a     new formulation of oritavancin by adjusting infusion time, concentration and     reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of     oritavancin   "
62182|NCT02471677|"     The purpose of this randomized controlled trial (RCT) is to compare a single injection of     corifollitropin-alfa versus daily injections of follitropin beta regarding the number of     oocytes retrieved, hormonal profile and follicle development in patients with high response     undergoing ovarian stimulation for in vitro fertilization treatment using a     gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger     and cryopreservation of all embryos.   "
62183|NCT02471664|"     To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for     repair of functional mitral regurgitation.   "
62184|NCT02471651|"     Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly     used treatment options for individuals with diabetic macular edema. However, some patients     continue to experience persistent diabetic macular edema and poor vision despite continued     laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory     mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for     individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth     factor injections. The purpose of this research study is to compare the effectiveness of     using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for     research participants with persistent diabetic macular edema (DME).   "
62185|NCT02471638|"     To assess the safety and performance of the PQ Bypass System to access, deliver guidewires     and implant stent grafts for a percutaneous fem-pop bypass.   "
62186|NCT02471625|"     The purpose of this research study is to evaluate whether data made by the ClearView System     can be used to detect whether someone has a traumatic brain injury and how severe the injury     is.   "
62187|NCT02471612|"     To compare APACHE II and P-POSSUM scoring system in emergency laparotomy.   "
62188|NCT02471599|"     The effect of tonsillectomy therapy on IgA nephropathy is still controversial.Few     prospective,randomized investigations have examined how tonsillectomy affects the shortterm     and longterm renal outcome of IgA nephropathy.This is A prospective,randomized ,controlled     study to explore the longterm effect of tonsillectomy for patients with IgA nephropathy.   "
62189|NCT02471586|"     To demonstrate the safety and efficacy of an OCT guided strategy for stent implantation.   "
62190|NCT02471573|"     To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all     protocol) with fresh embryo transfer (fresh ET).   "
62191|NCT02471560|"     The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes     in the abundance and diversity of commensal microbiota. The secondary objectives of this     study are as follows: To identify if there are differences in the gut microbiota composition     between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both     pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated     patients is reflected in the gut microbiota.   "
62192|NCT02471547|"     Transurethral Resection of Bladder Tumor (TURBT) is the initial treatment procedure for     urinary bladder cancer. Recurrence rate during the first year ranges between 15-38% in case     of low-intermediate disease. Current literature advocate using intravesical instillations of     Mitomycin-C (MMC) immediately post TURBT in order to reduce the rate of recurrence.      During the last decade, heated intravesical instillations have emerged as additional players,     in the treatment of recurrent disease. By most cases, the heated intravesical instillations     are given either by microwave hyperthermia (synergo®) or by conductive heat bladder wall     thermo-chemotherapy (BWT).      Previous reports suggest up to 59% reduction rate in recurrence following thermo-chemotherapy     upon recurrent disease. These outstanding reduction results haven't convinced significant     amount of urologists worldwide to use the intravesical instillation close after endoscopic     resection as TURBT, probably due to the fear of MMC adverse effects in an operated area or     the fear of complications due to perforated bladder. Preliminary results have suggested     favourable outcome when MMC is used prior to TURBT [see publication]. To the investigators'     knowledge no previous study has prospectively examined the effect of preliminary heated     intravesical installation with BWT.   "
62193|NCT02471534|"     The purpose of this study is to evaluate predictability of an abdominal compression-induced     change of blood pressure for fluid responsiveness in children.   "
63184|NCT02458625|"     This study is aimed to compare the efficacy of two mode of iron administration to treat post     partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron     sucrose and 6 weeks of treatment with oral iron supplement.   "
62194|NCT02471521|"     The purpose of this study is to find an optimal inspiratory pressure to provide adequate     tidal volume and prevent gastric insufflation in pediatric patients.      The children under 5 years old are randomly assigned to muscle relaxation group and     non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed     with muscle relaxant and mask ventilation is started by pressure-controlled mechanical     ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously     during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10     cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of     two methods. Tracheal intubation is done after detection of gas.      For non-relaxation group, mask ventilation is performed in a same manner, without muscle     relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is     administered and tracheal intubation is performed.   "
62195|NCT02471508|"     Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature     on spine. Spine curvature increases in youths as puberty progresses. The recommended     treatment for AIS is different depends on the spine deformity condition. For mild scoliosis     (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the     Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid     plastic material restrict nearly all movements of the wearers, which caused irritation.     Flexible brace is an alternative option, however, the efficiency of such treatment is     questionable in terms of controlling the spine curvature progression.      Biofeedback has proven to be effective for a number of physical, psychological and     psychophysical problems. The basic aim of biofeedback therapy is to support a patient in     realizing his/her self-ability to control specific psychophysiological processes.      In this study, a biofeedback embedded tank-top with a specialized design for adolescents as a     treatment option for AIS patients by monitoring the daily posture of the wearers.   "
62196|NCT02471495|"     This multicenter, prospective, single-arm, phase 3 study will assess the proportion of     disease-free patients, starting from administration of the first study treatment to at least     12-months after the first treatment, and up to 2 years (the latter only in patients choosing     to participate in longer-term disease-free-survival data collection).   "
62197|NCT02471482|"     This study is intended to see the effect of Mozart music on oxygen content of brain of     premature infants once they achieve corrected gestation of 28-32 weeks and are clinically     stable. Each baby is its own control. Difference of Oxygenation of brain will be measured     during period with and without music. In addition behavioural response of baby will be     recorded during intervention   "
62198|NCT02471469|"     The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected     miRNAS can be used to personalize enzalutamide therapy.      Furthermore the aim is to explore the relation between drug exposure and the decrease in the     selected biomarkers and treatment response.   "
62199|NCT02471456|"     Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous     vein (LSV) harvesting from the leg. This has been reported to be associated with a     significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50%     of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a     reduction in these complications was implemented within the investigators' service in 2012.     Although some initial reports of concerns regarding graft patency when the LSV is harvested     by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of     the EVH technology. Last year a service evaluation in the investigators' department showed     significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50     EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to     assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's     quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by     contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent     to patients along with a patient information sheet. It is estimated that data collection     would be completed within 3 months of start.   "
62200|NCT02471443|"     To determine the quality of life following the radical excision of recto-vaginal     endometriosis.   "
62201|NCT02471430|"     This study is a prospective, open-label, randomized, two-arm, dose-escalation exploratory     pilot clinical trial involving HIV-1 infected participants treated with suppressive     combination antiretroviral combination therapy (cART). The study will test whether combined     treatment with the histone deacetylase inhibitor panobinostat and the immunomodulatory     cytokine Interferon-alpha2a can reduce the residual reservoir of HIV-1 infected cells that     persist during treatment with currently available antiretroviral drugs.   "
62202|NCT02471417|"     Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise     capacity in athletes, healthy adults and subjects with both peripheral vascular disease or     COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The     investigators hypothesized that acute nitrate consumption might increase incremental shuttle     walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot     juice.   "
62203|NCT02471404|"     This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as     an addition to metformin is effective and safe in treating patients with type 2 diabetes when     compared to glimepiride (sulphonylurea) as an addition to metformin treatment.   "
62215|NCT02471248|"     A novel interactive exoskeleton robotic system with embedded force and motion sensors will be     developed to facilitate walking of stroke patients with hemiparesis. The robot will     synchronise with the gait pattern of the stroke patient to provide assistance in ankle     dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and     longer walking distance for stroke patients with drop foot problem. It can be applied on     unilateral side, which is suitable for stroke patients with hemiparesis. The whole system     design is lightweight, compact, comfortable, and user-friendly in hospital or at home     settings.   "
62216|NCT02471235|"     This study assessed whether a short course pulmonary rehabilitation programme with periodic     reinforcement exercise training and phone call reminders would help to increase physical     activity in COPD patients and also decrease readmissions for AECOPD.   "
63345|NCT02456506|"     This study evaluates the hyperfractionated IMRT in the treatment of patients with locally     recurrent nasopharyngeal carcinoma. Half of participants will receive hyperfractionated IMRT,     while the other half will receive conventional fraction IMRT.   "
62204|NCT02471391|"     This research will test the combination of two new drugs, called ibrutinib and ABT199, taken     together in the treatment of Mantle Cell Lymphoma. Other studies have indicated the potential     for these drugs to be used in the treatment of participants with Mantle Cell Lymphoma. In     this study, the investigators will test the combination of the two drugs together, in order     to determine what effects (good and bad) it has on mantle cell lymphoma.      This study has two phases. The first phase is the Primary Evaluation Phase and will closely     monitor the effects of ibrutinib and ABT199 for a period of 13 months. Participants who     complete 13 months of treatment and continue benefiting from the study treatments will be     allowed to continue both drugs until progression or intolerance in the Continuation Phase.     The purpose of this phase is to provide patients with continuing access to both ibrutinib and     ABT199. Patients will receive routine care from clinician, who will record any sideeffects     that may be experienced.      This is one of the first trials in the world to study the combination of ibrutinib and ABT199     together. Therefore the effectiveness of the combination of the study drugs will be assessed,     as will how they affect mantle cell lymphoma and how it develops resistance to the     treatments. The investigators also do not know whether combining the two drugs together will     cause unexpected side effects. Therefore, the study will monitor patients closely and perform     scans, blood tests, bone marrow biopsies and other tests at regular intervals.   "
62205|NCT02471378|"     Background:      - Malaria is a disease that affects many people in African countries. It is caused by germs     that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away.     Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want     to create a vaccine that will prevent malaria infection during pregnancy.      Objectives:      - To create a vaccine that will prevent malaria infection during pregnancy. To assess     possible vaccines using in-vitro tests with parasites taken from pregnant women.      Eligibility:      - Pregnant women ages 15 25      Design:        -  The study site is an area in Mali, West Africa.        -  Participants:        -  Will have blood drawn.        -  Will give consent for the blood sample to be used for future research.        -  May have a physical exam.        -  Participants who have malaria or anemia will get treatment.   "
62206|NCT02471365|"     Background:      - In a lifetime, a person may encounter tens of thousands of chemicals used as ingredients in     the products they buy. It s not easy to measure them because the companies that sell the     products don t have to tell the exact chemical ingredients. Researchers want to compare how     existing methods (e.g., surveys and models) measure exposure to chemicals in personal care     and household products.      Objective:      - To test and improve the ways that studies gather data about contact with chemicals found in     consumer products.      Eligibility:      - Healthy women volunteers ages 35 74 who use at least 15 consumer products a day.      Design:        -  Participants will be screened with medical history, pregnancy test, smoking test, and          blood sample. They will answer questions about their homes and products they use.        -  Participation will last about 30 hours over 12 days.        -  Researchers will:        -  Place air samplers inside and outside participants homes for 10 days. One sampler will          need to be plugged into an electrical outlet. It will make a low, continuous sound while          in operation.        -  Collect house dust samples and record all consumer products in the house.        -  Visit the house daily to collect samples.        -  Participants will:        -  Give a blood sample at a clinic twice.        -  Collect all urine voids for 10 days. They will label it and put it in a special cooler.        -  Wear 4 small devices that measure air pollution, chemicals, location, and activity.        -  Record what they eat and what consumer products they use. They will write these in a          diary and <TAB>photograph them on an iPhone provided to them.        -  On day 2 of the study, they will collect a duplicate sample of what they eat.        -  Take iPhone videos of their use of certain products.        -  Answer questions about chemical ingredients in their personal care products.   "
62207|NCT02471352|"     Background:      - Skin disease can have many causes. It can have widespread consequences, and in rare cases     can lead to death. Researchers want to determine the causes of various types of skin diseases     and find a way to treat them.      Objectives:      - To determine the causes of various skin diseases and find ways to treat them.      Eligibility:        -  People ages 2 and older who have:             -  A skin disease or at risk of developing a skin disease OR             -  A family member of persons with a skin disease        -  Healthy volunteers ages 2 and older      Design:        -  Participants will be screened under a separate protocol.        -  Participants may take a survey about how their skin condition affects their quality of          life.        -  Participants will have a medical history and a physical exam including a detailed skin          exam. Pictures will be taken of their skin to document any skin disease.        -  Participants will have specimens collected. This may include:             -  Several teaspoons of blood taken at each visit             -  Stool samples             -  Nail and body fluid (like saliva) samples             -  Cheek swabs. The inside of the cheek will be scraped for about a minute in each               direction to collect cells.             -  Collection of skin samples with:                  -  A swab (like a Q-tip)                  -  Gently scraping skin to remove the outer layers of cells                  -  Applying and removing 1-inch pieces of tape        -  Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken          each time.             -  An area of skin will be numbed with an injection.             -  A piece of skin the size of a pencil eraser will be removed using a small               instrument.             -  A flat scar usually develops at the biopsy site.   "
62208|NCT02471339|"     Background:      - People with neurofibromatosis type I (NF1) and plexiform neurofibroma (PN) tumors often     have chronic pain that his hard to control. People usually take medicines for the pain, but     they may not work well and might cause side effects. A new strategy called Acceptance and     Commitment Training (ACT) may help these people cope with chronic pain. ACT focuses on things     like values and living in the moment.      Objective:      - To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain.      Eligibility:      - People age 16 34 who have NF1, 1 or more PN tumors, and pain that interferes with their     daily functioning.      Design:        -  Participants will be screened with a physical exam, medical history, and questions about          their pain.        -  Participants will fill out questionnaires about their pain and feelings. Their heart          rate will be measured via ECG.        -  Participants will be divided into 2 groups randomly. One will wait 8 weeks.        -  The other will start training right away.        -  Participants will have 2 two-hour sessions with an ACT trainer. They will learn          techniques for setting goals based on personal values and other ways to cope with pain.          They will get a workbook and a CD to take home for practice.        -  Participants will do practice exercises at home between sessions. They will get weekly          emails with a practice exercise. They will join video chat sessions via home computer          with their trainer.        -  All participants will return to NIH after 8 weeks for questionnaires and an ECG. The          wait group will then start training. They will return 8 weeks later for questionnaires          and an ECG.        -  Six months later, they will complete questionnaires from home by computer.   "
62209|NCT02471326|"     Background:      - A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very     low for a long time. But cART can lose effectiveness and cause permanent side effects. If     treatment stops, HIV levels go up again. Researchers want to see if a new product can control     HIV levels when a person is off cART.      Objective:      - To see if the new product VRC01 is safe and can control the HIV level in the blood when a     person is not taking cART.      Eligibility:      - Adults ages 18 65 with HIV who are willing to interrupt their treatment for at least 24     weeks.      Design:        -  Participants will be screened with:        -  Physical exam        -  Medical history        -  Heart tests        -  Blood and urine tests.        -  Their HIV drugs may be switched. They will keep taking them until a few days after Visit          1.        -  Visit 1: Repeat screening procedures.        -  Participants will also have genetic testing and leukapheresis. For this, blood will be          removed through a needle in one arm and circulated through a machine that removes white          blood cells. The rest of <TAB>the blood is returned through a needle in the other arm.        -  They will get the first study drug dose through a thin tube in an arm vein for about 1          hour.        -  For 24 weeks, participants will have 15 visits. They will have blood drawn every visit.          At some visits they will repeat the screening procedures and get another VRC01 dose.          They may have another leukapheresis.        -  Four weeks after the last dose, participants will restart their cART. For 20 weeks, they          will have monthly visits to repeat the screening procedures and discuss new symptoms.   "
62210|NCT02471313|"     Background:      - Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also     include other minimally invasive tumor treatments such as transarterial chemoembolization     (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a     cure. Researchers want to learn more about the effects of TACE on liver tumors and     surrounding tissue. To do this, they will use a positive emission test (PET) and a     radioactive tracer called [18F] FMISO.      Objectives:      - To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding     tissue after TACE.      Eligibility:      - People age 18 and older with liver cancer who have been approved to have TACE.      Design:        -  Participants will meet with a study researcher to see if they can take part in the          study.        -  Participants will have TACE under a separate NCI protocol or at a hospital other than          the NIH Clinical Center.        -  Before and after TACE, participants will have a CT and MRI of the abdomen. For these          scans, they will lie in a machine that takes pictures of their body. They will also have          blood tests and a physical exam.        -  The [18F] FMISO imaging study will be performed at NIH only.        -  Participants will have an intravenous catheter placed in their arm (if they do not have          one). The [18F] FMISO tracer will be injected.        -  Participants will have PET-CT scans. Each scan will take about 30 minutes.        -  Some participants will also have [18F] FMISO and PET-CT scans before TACE.        -  As part of standard care for TACE, participants will have CT and MRI scans at regular          intervals. This will evaluate tumor response.   "
62211|NCT02471300|"     Background:      Research shows that restricting calories has a positive effect on immune cell health in     healthy people. Researchers want to learn if it will help people with asthma. They want to     better understand how the body s immune response and lung function responds to short-term     calorie restriction. For this, they want people to fast (no food or drink except water) for     24 hours.      Objective:      To explore the benefits of calorie restriction in people with asthma.      Eligibility:      Healthy people ages 18 to 60 who have a history consistent with asthma and prior     documentation of airflow obstruction or wheezing.      Design:        -  Participants who have taken part in asthma research at NIH will be screened with a          telephone interview. All other participants will have a medical history, blood tests,          and physical exam.        -  Eligible participants will return to the NIH Clinical Center one morning for 2 hours.          They will be fed breakfast. They may have blood and urine tests.        -  Participants will then fast for 24 hours.        -  Participants will return to the Clinical Center the next morning for 4 hours. They will          have blood drawn. They will eat breakfast and then repeat blood draws 2.5 hours later.          They will have a urine test.        -  Blood and urine tests will be done at the end of the fast and after the meals to confirm          that the participant fasted for the full 24-hour period.        -  Participants will have lung function tests and exhaled gas measurements. A machine will          measure the volume of air they can breathe out. Some gases in the breath increase with          inflammation. Participants will breathe into a machine that analyzes the gases in their          breath.   "
62212|NCT02471287|"     Background:      Research has identified some of the genes involved in inherited eye diseases. But for many of     these diseases, the genes are not yet known. Researchers want to try to find these genes.     They also hope to learn more about how symptoms differ in people with similar gene changes.      Objective:      To learn more about genes involved in eye diseases.      Eligibility:      People who have a known or suspected inherited eye disease, and their relatives.      Design:        -  All participants will have a medical history, physical exam, and eye exam. They may have          blood taken.        -  Participants with an eye disease may have eye cell samples taken using a swab or biopsy          procedure.        -  Participants may have a skin biopsy. A (Omega)-inch piece of skin will be removed.        -  Participants may have blood drawn and the red blood cells removed. The remaining serum          will be made into an eye drop solution for the participant.        -  Participants may provide samples of tears, urine, saliva, stool, hair, or inner cheek          cells.        -  Participants may have a retina test. They may also have a test that uses light to          measure retina thickness.        -  Participants may have an eye movement test. Electrodes will be placed on the skin next          to both eyes.        -  Participants may have a fluorescein angiography. A dye will be given through an          intravenous line in the arm. A camera will take pictures of the dye as it flows through          the eyes blood vessels.        -  Participants may have microperimetry. They will sit at a computer screen and press a          button when they see a light.        -  Participants may have an eye movement test. They will wear contact lenses or goggles and          watch a series of spots on a computer screen.   "
62213|NCT02471274|"     To evaluate the effect of mild, moderate, or severe hepatic impairment on the     pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared     with healthy, demographically-matched subjects.   "
62214|NCT02471261|"     Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.   "
62217|NCT02471222|"     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group     study of ADS-5102 extended release (ER) capsules, an investigational formulation of     amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS.     ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher     plasma amantadine concentrations in the early morning, sustained throughout the afternoon,     and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to     deliver its primary treatment effect during the day, and potentially reduce the adverse     events of immediate-release amantadine when the patient is asleep.   "
62218|NCT02471209|"     To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial     buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five     infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were     enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood     flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2     and 3% sevoflurane.   "
62219|NCT02471196|"     This study evaluates the effect of ORM-12741 on agitation/aggression symptoms in Alzheimer's     disease. Two thirds of the patients will receive ORM-12741 and one third will receive     placebo.   "
62220|NCT02471183|"     This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled     treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off     and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a     similar way. The purpose of the study is i) to investigate the safety and tolerability of     oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the     effects of oral selexipag on PAH severity and exercise ability before and after transition,     and iii) to gain new information about the patients experience taking oral selexipag compared     to inhaled treprostinil. Study participants may stay in the study until the FDA has granted     marketing authorization.   "
62221|NCT02471170|"     The purpose of this study is to collect blood samples to detect potential markers of     pancreatic cancer in the blood and link these findings to medical and health information.     Information from this study may help to provide insight into the detection of pancreas cancer     in the blood before it can be found by other methods or provide a method of monitoring the     status of pancreatic cancer throughout a treatment course. Another purpose of this study is     to collect blood to create a biobank.   "
62222|NCT02471157|"     An observational trial to determine whether preoperative hormonal status predicts outcomes of     oncologic surgery.   "
62223|NCT02471144|"     This is a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept     in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with     severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years will be     enrolled, of which at least 30 will be 6 years to <12 years old. It is expected that subjects     will be enrolled at approximately 70 study sites worldwide.   "
62224|NCT02471131|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of     developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of     AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality.     The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular     AF. The WATCHMAN™ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the     risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with     epicardial devices is known to be difficult and not free of risks.It thus will be interesting     to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid     ablation approach.   "
62225|NCT02471118|"     This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed     to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat     subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of     inflammation, whose pain persists despite receiving maximum tolerated doses of conventional     therapy.   "
62226|NCT02471105|"     This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a     clinical setting.   "
62227|NCT02471092|"     The purpose of this study is to develop and test modified milk protein products to determine     the effects of amino acids on food intake, satiety, insulin secretion and glucose control by     insulin-independent action in healthy adults.   "
62228|NCT02471079|"     Rationale:      The number of breast cancer (BC) patients at risk for long-term radiation-induced health     problems is increasing, as their outcome is improving due to intensified treatment regimens,     such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with     the highest risk for radiation-induced health problems is crucial for developing strategies     for primary and secondary prevention, which may contribute to healthy ageing.   "
62229|NCT02471066|"     The management of functional psychogenic movement disorders (FNPMD) is challenging for     neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme     can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance     imaging studies have demonstrated abnormalities in motor control at cortical level,     hyperactivity of limbic system and disturbance of connectivity between these two systems     leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a     possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis     2011, Garcin, 2013).      In this protocol our objectives are twofold :        1. to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind          randomized controlled study        2. to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD   "
62230|NCT02471053|"     As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are     becoming increasingly apparent. Most prominent are the toxic effects on the heart     (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular     disease (CVD). The investigators hypothesize that an individualized aerobic training program     for cancer patients receiving active treatment will be both feasible and safe and will result     in improvements in overall levels of physical activity and quality of life.      Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates,     along with program safety. Efficacy will be assessed by evaluating changes in health-related     outcomes.   "
62233|NCT02471014|"     Pneumococcal infections are a leading cause of adult and childhood hospitalization and death.     It has been shown that obese individuals are at higher risk for this bacterial infection. As     a result, investigators will vaccinate obese individuals to see if they are offered the same     level of protection from the vaccine as normal-weight individuals. The vaccine used for this     particular bacterial infection is called Pneumovax 23.      The purpose of this study is to compare how body mass index affects protection that the     vaccine provides against these bacteria.      Primary Hypothesis: Levels of protection from the vaccine are no different in pre- and post-     vaccination in healthy BMI individuals and obese individuals.   "
62234|NCT02471001|"     In the last few years, anaesthetic agents, Isoflurane used in heart surgery have shown some     benefits to reduce the risk of heart muscle damage. Many research studies have been conducted     to reveal the benefit relationship between Isoflurane and the risk of heart muscle injury     during heart surgery. However, there is a knowledge gap regarding the optimal level of     Isoflurane concentration to confer the benefit of heart muscle-protective properties.     Therefore, this study is conducted to answer that question by measuring the Isoflurane     concentration in the blood vessels. It also assesses whether Isoflurane concentration in the     blood is correlated to the oxygenator exhaust level of Isoflurane in the heart-lung machine.   "
62235|NCT02470988|"     The purpose of the study is to investigate the process of symptom change in Cognitive     Behavioural Analysis System of Psychotherapy (CBASP), and how the individual components of     the therapy affect this change in individuals with chronic depression.   "
62236|NCT02470975|"     Children with newly diagnosed cancer and their parents will be contacted and invited to     participate. Upon agreement, children will be interviewed, both parents will fill out     questionnaires and be additionally interviewed. Using a 3-wave longitudinal design, mainly     self-reported parental we-appraisals and we-disease-appraisals, couple dyadic coping (DC) and     parent-child DC during a course of 12 months will be examined. Additionally, during brief     separate interviews, the parents' speech will be coded for we-appraisals and expressed     emotion regarding the other partner and the child. Findings will provide information on how     family variables affect child QoL over 12 months.   "
62237|NCT02470962|"     This study evaluates the function of the heart in young patients with muscular dystrophy type     Duchenne or Becker. Participants have their hearts examined at regular intervals by     ultrasound (echocardiography) and cardiac magnetic resonance imaging.   "
62238|NCT02470949|"     This project will investigate the influence of experimentally manipulated perceived social     standing on eating behavior and obesity risk.   "
62239|NCT02470936|"     A randomized controlled trial of a technology-based lifestyle intervention vs. usual care     among men with low-risk prostate cancer to determine the acceptability and feasibility of the     intervention and the effect of the intervention on behavior change related to exercise, diet,     and not smoking.   "
62240|NCT02470923|"     The objective of the study is to assess the effect of in-hospital intensive counseling and     NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to     smoking cessation behavioral intervention.      This is prospective randomized clinical trial. The study population will include smokers     subjects admitted to internal medicine departments at Soroka University Medical Center.      The study population will be divided randomly into three arms according to intervention     intensity (ratio 1:1:1).   "
62241|NCT02470910|"     This research study is evaluating whether a standard prostate MRI examination can improve     radiation therapy planning for prostate cancer.   "
62242|NCT02470897|"     This phase I/II trial studies the side effects and best dose of stereotactic body radiation     therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid     radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation     therapy is a specialized radiation therapy that sends x-rays directly to the tumor using     small, high doses of radiation over several days and may cause less damage to normal tissue.     This treatment schedule allows for a higher dose of radiation to be administered over a     shorter overall treatment period in comparison to standard radiation therapy.   "
62243|NCT02470884|"     A prospective multi-center, single arm feasibility study to assess the safety and performance     of the Boston Scientific Fully Absorbable Scaffold.   "
62244|NCT02470871|"     The purpose of this study is to investigate the pharmacokinetics (PK) and safety of rVIIa-FP     (CSL689) in a total of 10 to 16 male or female adults with inherited coagulation factor VII     (FVII) deficiency. Subjects will receive a single dose of their routine FVII replacement     product (ie, either recombinant activated coagulation FVII [rFVIIa, eptacog alfa (activated)]     or plasma-derived FVII [pdFVII]) as a comparator, and will then be randomly assigned to a     single low dose or a single high dose of the study product CSL689 (8 subjects per CSL689 dose     level). Serial blood samples for PK analysis will be taken up to 24 hours after the eptacog     alfa (activated) or pdFVII injection, and up to 48 hours after the CSL689 injection. Subject     safety will be routinely monitored throughout the study.   "
62245|NCT02470858|"     The study is designed to test the hypothesis that the addition of a protease inhibitor to     dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten     the treatment duration to 3 weeks.   "
62246|NCT02470845|"     The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment     of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.   "
62249|NCT02470806|"     The aim of this study is to compare the clinical efficacy of two types of NPWT systems;        -  tNPWT systems that has successfully completed a coding verification request with CMS and          has the following capabilities (e.g., range of negative pressure, connective tubing,          canister, foam or gauze filler, and approved for home use) and,        -  a portable, canister-less, battery operated, disposable single-use NPWT system (PICO) to          see if there are any observed differences with regard to the clinical efficacy of the          two devices.   "
62250|NCT02470793|"     To assess and compare the complications and results of different lamellar endothelial     keratoplasty techniques and its variations.   "
62251|NCT02470780|"     This study investigates the effect of treating Small Intestinal Bacterial Overgrowth (SIBO)     in patients with Parkinson's Disease (PD). It will test the hypothesis that treating SIBO     with the antibiotic rifaximin will improve motor complications in previously SIBO-positive PD     patients.   "
62254|NCT02470741|"     PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a     randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women     with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to     either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole     2.5mg/day and an identical placebo capsule (Group B).   "
62255|NCT02470728|"     Pain is a symptom that drives hospital admissions, and pain management is required by most     patients during their hospital stay. Further, the use of medications such as opioids can lead     to upward-spiraling doses, especially among chronic pain patients whose resource utilization     rates are high. Many initiatives aim to reduce the costs of these high-resource utilizing     patients. One exciting aspect of improving the management of pain is that this may help     prevent patients from ever becoming high-cost in the first place. The purpose of this study     is to examine the impacts of an early intervention pathway, in comparison to the current     standard of care, for the treatment of pain in opioid tolerant patients. It is hypothesized     that patients randomized to the early intervention pathway, in comparison to the control,     will lead to decreased costs of care, a reduction in opioid usage within 3 and 6 months, and     decrease in hospital readmission rates.   "
62256|NCT02470715|"     The primary aim of this study is to identify drivers of cancer by performing comprehensive     genetic, proteomic, and metabolomic characterization of patient samples as a basis for     understanding the underlying cause of disease.   "
62257|NCT02470702|"     This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of     multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.   "
62258|NCT02470689|"     Epidermolysis bullosa simplex type Dowling-Meara (EBS-DM) is one of the most severe subtypes     of EBS. Blisters and erosions of the skin and mucous membranes upon minor trauma are the     consequence of dominantly inherited mutations in either the keratin 5 (K5) or keratin 14     (K14) gene, which encode proteins constituting the intermediate filament (IF) network in     basal keratinocytes . Autosomal dominant mutations lead to a conformational change and an     increased self-aggregation of the protein. Upon stress, aggregates present in the periphery     of the cytoplasm, subsequently leading to the disintegration and collapse of the IF network.     Clinically, patients suffer from blistering of the skin and mucous membranes upon minor     trauma, resulting in an impaired life quality due to pain and pruritus . In vitro studies on     Dowling-Meara keratinocytes revealed a significant upregulation of the pro-inflammatory     cytokine interleukin-1beta (IL-1ß). Apart from paracrine effects of IL-1ß upon wounding (e.g.     attraction of lymphocytes, activation of dermal fibroblasts), IL-1ß also activates     keratinocytes via the cjun N-terminal kinase (JNK) stress pathway. The activation of this     pathway leads to the activation of a number of transcription factors and the enhanced     transcription of a number of genes, like matrix metalloproteinases, kallikreins, but also     IL-1ß itself and K14 . Interestingly, this state of activation is constitutive and was also     found in keratinocytes from non-lesional sites. It seems that the upregulation of IL-1ß and     K14 in the presence of dominant Dowling-Meara mutations, results in a positive feedback loop,     potentially aggravating the EBS-DM phenotype. This was strongly corroborated by the fact that     when impairing IL1ß signaling, using IL-1ß neutralizing antibody (IL-1Ab) or the small     molecule diacerein, expression levels of IL-1ß and K14 decreased and keratinocytes were much     less susceptible to heat shock in vitro . Furthermore, activation levels of JNK widely     correlated with expression levels of K14 and IL-1ß. (Wally V et al, 2013). These findings led     to the hypothesis that blocking IL-1ß will also lead to an amelioration of the EBSDM     phenotype in effected patients. Based on previous in vitro findings diacerein was chosen to     be topically applied in a pilot study with five patients suffering from EBS-DM. In that study     , each participant received 1% diacerein-cream for one armpit, and placebo for the other     (randomized withdrawal). The number of blisters was reduced significantly (left: -78%; right:     -66% of baseline) within two weeks and remained significantly below the initial level even     during withdrawal in four patients. These findings pointed to a relevant effect of diacerein     and provide important information for our confirmative study.      Diacerein is a component of the rhubarb root, which is reported to block the release of     active IL-1b by inhibiting plasma membrane-bound IL-1 converting enzyme . Diacerien is     already approved for systemic application in osteoarthritis . In general, small molecules     (SM) are low molecular weight compounds with biological functions that can influence     molecular processes. They allow a symptomatic treatment, offering a short-term benefit for     patients in terms of an amelioration of the phenotype. Although this kind of treatment does     not correct genetic alterations, it can still be highly beneficial by damping down disease     symptoms, thereby increasing life quality and minimizing secondary manifestations.      It is important to emphasize that besides dressings, there are currently no other treatments,     therefore, investigators do not prevent an accepted treatment for the patient and there is no     risk for the participant. The treatment will be given only to the armpits although the     disease can involve other areas, so stopping dressings in the armpits during the study does     not risk the patient. Should there be any deterioration of the patient, whether it is related     to the treatment with diacerein or not, investigators will stop the use of diacerein.   "
62259|NCT02470676|"     The purpose of this randomized control trial is to determine whether cervical pessary plus     vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery     rate, and improving perinatal outcome, among women presenting with an asymptomatic     mid-pregnancy short cervix, in singleton and twin gestations.      All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24     completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with     cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in     the clinical trial.      Women who meet eligible criteria will be invited to participate in the clinical trial.      Women will be randomly assigned into one of the following groups: group A (vaginal     progesterone) or group B (vaginal progesterone + pessary).      Follow-up visits for ultrasound assessment of fetal growth and cervical length will be     carried out every two weeks until 37 weeks of gestation.   "
62260|NCT02470663|"     Patients diagnosed with, or in risk of osteoporosis regularly take calcium dietary     supplements, although their contribution to BMD maintenance, prevention of bone loss or     reduction of the risk of fracture is questionable. Freshwater crayfish rely on amorphous     calcium carbonate (ACC), a thermodynamically instable and very rare biomineralized polymorph     of calcium carbonate, as the main mineral in the exoskeleton and in their temporary storage     organ, the gastrolith. The study hypothesis is that amorphous calcium carbonate (ACC) will     have an advantage over calcium carbonate in improving BMD of pediatric IBD patients with     reduced BMD. The investigators will include children 10-18 years old with IBD and reduced     bone density to recieve regular calcium or amorphic calcium for 12 months with follow up of     bone density and confounders as disease activity and medications.   "
62261|NCT02470650|"     The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of     initiation of antiretroviral treatment. three strategies of treatment.   "
62262|NCT02470637|"     Primary Objective:      To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different     single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous     (SC) insulin lispro in a euglycemic clamp setting.      Secondary Objectives:      To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single     doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a     euglycemic clamp setting.      To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza     inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp     setting.      To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza     inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp     setting.      To assess the safety and tolerability of 3 different single doses of Afrezza inhaled     Technosphere insulin.   "
62264|NCT02470611|"     In the past few years, studies have evaluated the effect of systemic use of sodium     alendronate, especially in the treatment of structural bone defects caused by periodontal     diseases. This study evaluated the effects of non-surgical periodontal treatment associated     with the topical application of 1% sodium alendronate on clinical and topographical     parameters. Chronic periodontitis patients were recruited for the present study and were     monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.   "
62265|NCT02470598|"     The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or     improvement of the hydration status of more than 250 PD patients, and to observe the     tolerability of the therapy over a long period.   "
62266|NCT02470585|"     The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in     women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian,     fallopian tube, or primary peritoneal cancer.   "
62267|NCT02470572|"     A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyx™     Integrated Digital Pathology (IDP) system with de-identified and previously signed-out cases     from all major organ systems. Pathologist will read and diagnose cases on a conventional     light microscope and on the Omnyx™ IDP system for Whole Slide Images (WSI) with a randomized     read order. College of American Pathologists (CAP) cancer protocol checklists will be used to     capture diagnostic reporting.      Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and     compared directly to the Ground Truth (GT) diagnosis for both modalities.   "
62454|NCT02468141|"     To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from     anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per     day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test     such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.   "
62268|NCT02470559|"     This phase I trial studies the side effects and best dose of activated T-cell therapy when     given together with low-dose aldesleukin and sargramostim in treating patients with ovarian,     fallopian tube, or primary peritoneal cancer that is stage III-IV, has not responded to     previous treatment, or has come back. Activated T cells that have been coated with     bi-specific antibodies, such as anti-cluster of differentiation (CD)3 and anti-human     epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways     and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor     cells. Colony-stimulating factors, such as sargramostim, may increase the production of blood     cells. Giving activated T-cell therapy with low-dose aldesleukin and sargramostim may be a     better treatment for ovarian, fallopian tube, or primary peritoneal cancer.   "
62269|NCT02470546|"     Primary aim:      -To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in     patients with liver cirrhosis.      Secondary aim:      -To evaluate if metformin is a safety drug in patients showing liver cirrhosis.   "
62270|NCT02470533|"     Rationale:      This study will compare head to head in patients with hepatocellular carcinoma (HCC)     ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial     chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm, stereotactic     body radiation therapy (SBRT). The investigators hypothesis is that the time to progression     is more favorable after SBRT than after TACE-DEB. The expected time to include the required     patients for this trial will be four years.      To the best of the investigators knowledge this study will be the first in the world that     will compare both techniques in a randomized trial.      Objective:      To assess the time to progression after TACE-DEB and after SBRT in a comparable population of     patients diagnosed with HCC.      Study design:      Randomized, prospective, open-label, and phase II study.      Study population:      Patients diagnosed with HCC, Child-Pugh grade A, one to three tumors, cumulative diameter ≤     6cm, and ≥ 18 years old.      Intervention:      Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with     doxorubicin or the experimental arm, SBRT.      Main study parameters/endpoints:      The primary endpoint of this study will be time to progression, defined as time from     randomization to radiological progression.      Secondary endpoints will be:        -  Time to local recurrence        -  Response rate (complete and partial response)        -  Overall survival        -  Toxicity        -  Quality of life.   "
62271|NCT02470520|"     The aim of this study is to measure plasma levels of essential vitamins, trace elements and     amino acids in critically ill patients with severe AKI. In patients who are treated with     continuous renal replacement therapy, we plan to evaluate whether there are any additional     losses of nutrients into the filtrate.   "
62272|NCT02470507|"     The immune response to kidney damage during acute kidney injury (AKI) is an important     contributor to the prolonged lack of renal function and progression of kidney injury. Most     data related to intrarenal and interorgan pathways in AKI stem from animal research with     sometimes conflicting results. Accurate evaluation of these processes in humans and     identification of early diagnostic tools are critical for the development of strategies to     prevent and attenuate AKI-related morbidity and mortality in patients.      The aim of this study is to evaluate immune function and miRNA expression in hospitalised     patients with and without AKI.   "
62273|NCT02470494|"     The EarLens System is an assistive hearing device that is intended to provide amplification     for the treatment of patients with sensorineural hearing impairment. The purpose of the     proposed study (Extended Investigation under the Continued Access Policy) is to continue to     allow access to the investigational medical device with the collection of device utility and     clinic process-flow data while the marketing application is under review at the FDA.   "
62274|NCT02470481|"     The purpose of this study is to conduct full psychometric testing of the Early Arthritis for     Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations   "
62275|NCT02470468|"     The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune     enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression     free survival (PFS).   "
62276|NCT02470455|"     The study was conducted to find out any possible effect of Atorvastatin on glycemic     parameters in prediabetic patients.   "
62277|NCT02470442|"     The purpose of this study is to characterize the airway responses to desflurane during     maintenance of and emergence from anesthesia in children whose airways were supported with     laryngeal mask airways (LMAs).   "
62278|NCT02470429|"     The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total     ocular surface staining scores (TOSS) at Day 42.   "
91509|NCT02088307|"     Evaluation of the metabolic and physiological characteristics of patients with diagnosed     Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife.   "
62279|NCT02470416|"     Little is known about the prevalence of small bowel polyps in patients with sporadic     Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel     polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas     by performing small bowel capsule endoscopy and comparing the results to those acquired from     a control cohort undergoing VCE for accepted indication at our centre.   "
62280|NCT02470403|"     A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and     normoglycemic patients with elevated body mass index (BMI)   "
62281|NCT02470390|"     A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and     bioavailability study in healthy volunteers.   "
62307|NCT02470052|"     This is a multicenter,single-arm,open-label study designed to evaluate improvement of lung     function and safety after treatment with OL-BF-001 for severe emphysema.      OL-BF-001 consists of a bronchial valve, deployment catheter, loader and airway sizing kit. A     bronchial valve is a small, umbrella-shaped, one-way valve that is placed inside the airways     of one lung. It is used to redirect air from the less healthy to the more healthy parts of     the lung. This helps to reduce over-inflation and may improve overall lung function and     quality of life for people living with emphysema.   "
62308|NCT02470039|"     This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338     (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with     or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral     antidiabetic therapy   "
62282|NCT02470377|"     The goal of this study is to determine whether external neuromodulation using repetitive     transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is     experienced by individuals with mal de debarquement syndrome (MdDS). Mal de debarquement is     translated as the sickness of disembarkment, and refers to the chronic feeling of rocking     dizziness that occurs after exposure to passive motion. Treatment for MdDS is limited and     morbidity is high. The goal of the study is to determine whether rTMS can suppress the     rocking dizziness of MdDS and to determine whether imaging and electrical biomarkers can aide     in more effective targeting. The investigators will make correlations between functional     magnetic resonance imaging (fMRI), electroencephalography (EEG), and specific clinical     features to determine whether functional connectivity between particular hubs in the brain     correlate with clinical improvement.   "
62283|NCT02470364|"     The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related     quality of life scale for myasthenia gravis) for use with French-speaking patients in France     and to evaluate its psychometric properties to ensure reliability and validity.   "
62284|NCT02470351|"     This study aims to describe in depth the CNS, CNS HIV reservoir and CNS viral rebound in     consenting SEARCH 019 subjects prior to, during and after the SEARCH 019 study intervention     (VHM + ART or ART only), at 1) baseline, 2) end of study intervention and start of ART     interruption, 3) viral rebound (if occurring) or mid-way during observed ART interruption,     and 4) at the end of ART interruption. Study SEARCH 026 itself does not employ any     therapeutic interventions. However, consenting subjects will participate in lumbar puncture,     non-contrast MRI + MRS, and neuropsychological testing at at least three and at most four     time points. Any of the 15 subjects to be enrolled in SEARCH 019 may consent to study SEARCH     026 participation and hence a maximum of 15 subjects may enroll. As this is a sub-study, data     will be shared from study SEARCH 019 and no interventions (venipunctures) will be repeated     unnecessarily.   "
62285|NCT02470338|"     This study is to show that the investigators believe the Modified Brostrӧm Procedure (MBP)     can be completed without a routine ankle arthroscopy. Routine ankle arthroscopy, if     determined not to be necessary in all cases, is a waste of resources in terms of operating     room, surgeon, and staff time as well causing an increase in hospital financial expenses.     Most importantly, this procedure is morbid. Ankle arthroscopy forces a patient's foot into     distraction for up to one hour, exposes the patient to potentially longer anesthesia exposure     that is unnecessary, increases infectious risks, and requires exposure at the portal sites     near superficial nerves.   "
62286|NCT02470325|"     A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in     children with neurological diseases. The clinical trial will include 40 children divided into     two groups: children with spasticity and dystonia due to cerebral palsy, and children with     spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be     randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to     THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various     variables will be collected including: medication intake, spasticity, dystonia score, pain     scale, restlessness scale, quality of life measures, safety tests, side effects, and an     addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia     and spasticity in children with motor disability related to genetic neurodegenerative     diseases and cerebral palsy and as a result improve motor function, non-motor functions and     quality of life.   "
62287|NCT02470312|"     The goal of this registry/observational study is to collect data on the clinical utility of     MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and     electrophysiology (EP) procedures.   "
62288|NCT02470299|"     There is a move towards personalized medicine in cancer care, and significant effort is     underway to evaluate new targeted therapeutics for the treatment of ovarian cancer. One way     to identify potential new drug targets is by screening a drug library to determine whether     drugs in the library target key kinase or enzymatic sites in cellular signaling pathways.     Previous preclinical work and pilot studies demonstrated that ketorolac (a type of     non-steroidal anti-inflammatory drug) inhibits GTPase activity in ovarian cancer cells     retrieved from the post-operative peritoneal cavity.      The purpose of this study is to confirm that this inhibitory effect is ketorolac driven and     not a specific effect of the post-operative peritoneal compartment.   "
62289|NCT02470286|"     This study is a block-randomized, double-blind, placebo-controlled, single/multiple-dose,     dose-escalation, Phase I clinical study to investigate the pharmacokinetics and     safety/tolerability of SA001 in healthy male volunteer.   "
62290|NCT02470273|"     The purpose of this study is to calculate the sensitivity and specificity of a novel imaging     device and associated software algorithm in detecting early stage melanoma versus nevi of the     skin. The instrument, which was invented by the PI, for the purposes of this study, will be     loaned to three external (to Rockefeller) institutions and used on patients who are scheduled     for biopsy of pigmented lesions. The purpose of correlating the output screening result of     the novel device and the output diagnosis of the gold standard histology analysis procedure     is so that these two diagnoses can be compared to generate the number of true positives, true     negatives, false positives and false negatives for the novel device. The purpose of     disseminating the device to the external institutions is to achieve the appropriate power     such that the specificity can be evaluated at 99% sensitivity. The rationale for the power     needed in the study is that in order to be clinically useful, the device needs to be     extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation,     leading to potential progression of melanoma, the most deadly form of skin cancer.   "
62309|NCT02470026|"     This study investigates influences of nordadrenergic activity on cognition in patients with     major depression regarding influences of early life stress.   "
62310|NCT02470013|"     The aim of this study is to assess the benefit of a 3-month intervention with oral     nutritional supplements (ONS) in older ambulant patients with reference to functional     limitations and quality of life as well as the consumption of health care resources.   "
62455|NCT02468128|"     This is a randomized, double blind, placebo-controlled, single dose study to assess the     safety, efficacy and pharmacokinetics of intramuscular sebacoyl dinalbuphine ester (SDE) for     post-hemorrhoidectomy pain management.   "
62456|NCT02468115|"     A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects     after inoculation with influenza A virus (H1N1).   "
62291|NCT02470260|"     Pre-diabetes, type 2 diabetes, and their related conditions, adiposity and insulin     resistance, are more prevalent in minorities Northern Manhattan compared to the general     population of the United States. Despite knowledge of the main biologic determinants of these     conditions (high caloric intake and sedentarism) the prevalence of these conditions continue     to increase. In addition, these conditions can cause mental health problems including     increased depressive symptoms and cognitive impairment. Thus, the investigators decided to     conduct a community based study of middle aged Hispanic men and women aged 50 to 64 years at     baseline in order to:        1. Document the prevalence and incidence, of pre-diabetes, diabetes, overweight, obesity,          and associated conditions (e.g. dyslipidemia, hypertension).        2. Study how social determinants of health (SDOH) affect these conditions.        3. Study the consequences of these conditions on aging and mental health outcomes,          including cognitive impairment.   "
62292|NCT02470247|"     Diagnostic imaging for vascular investigations and endovascular procedures frequently require     the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney     injury can appear: the contrast-induced nephropathy (NPCI).      NPCI is associated with an increase of patients' morbidity and mortality. One of the     conventional methods proposed to limit this NPCI is an oral administration of     N-acetylcysteine (NAC) associated with hydration performed 12 hours before and 12 hours after     the injection. However, in some patients this method cannot be performed due to a high risk     of heart failure although they are generally at high risk of NPCI.      Recently, it has been shown, in a randomized trial, that remote ischemic preconditioning     (several cycles of upper-arm ischemia-reperfusion with a pressure cuff inflator) associated     with hydratation and NAC reduced the occurrence of NPCI after a coronary angiography as     compared with NAC and hydration only. .      We hypothesized that the use of RIPC in patients at high risk of NPCI and who cannot receive     NAC and hydratation (e.g. patients with aortic stenosis and eligible for Transcatheter Aortic     Valve Implantation (TAVI)) could be promising.   "
62293|NCT02470234|"     To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate     hydrochloride extended-release) capsules under fed conditions in male or female children 4 to     under 6 years of age with ADHD.   "
62294|NCT02470221|"     This study is aim to assess the effect of goal-directed intraoperative fluid therapy on     patient's postoperative incidence rates of complications, length of hospitalization and     hospitalization cost.      This is an observational study followed cohort study design, due to the two therapies were     not randomized assigned to the two cohorts. The details are described as follow.   "
62295|NCT02470208|"     The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine     immune competence against CMV infection in stem cell transplantation.      To determine the utility of the T-SPOT.CMV assay used before transplantation to determine     immune competence against subsequent CMV reactivation and to determine the utility of the     T-SPOT.CMV assay used after transplantation to determine immune competence against subsequent     CMV reactivation.   "
62296|NCT02470195|"     Difficult airway management is a crucial point that may influence outcomes of patient in this     critical situation. Education for this topic is of main importance for resident of     anesthesiology. Procedural simulation workshop allows participant to use device dedicated to     difficult airway management. Investigators included this workshop to a state education     program of anesthesiology resident in second year and compared to their homonym in another     state where no specific organized workshop is integrated to the education program.   "
62297|NCT02470182|"     The purpose of this study is to learn more about breathing disorders during sleep. The     investigators want to learn how breathing sounds made during sleep relate to breathing     disorders during sleep.   "
62298|NCT02470169|"     Four hundred and fifty women with endometriosis will be divided into 3 equal groups using     computer generated random numbers: Group 1 will have up to 4 stimulated intrauterine     insemination (IUI) cycles, group 2 will have up to 4 unstimulated cycles, women who do not     become pregnant after the 4 cycles in groups 1 and 2 will be advised to have regular     intercourse at the expected time of ovulation. Group 3 will be the control group will be     advised to have regular sexual intercourse at the time of ovulation for 4 months   "
62299|NCT02470156|"     This 12-month randomized trial is designed to evaluate the impact of low intensity     (quarterly) versus high intensity (monthly) wellness coaching programs on women's success     achieving individual health goals related to active living and healthy eating and changes in     these health behaviors over time.   "
62300|NCT02470143|"     The pilot study will investigate the usability of a mobile cycling application in a cardiac     patient population during a one month study period.      The application's effectiveness regarding ability to reduce fear and increase motivation to     exercise will be assessed.   "
62301|NCT02470130|"     Resident in advanced medical training participated to high fidelity simulation education     program in Lyon. Alternatively 1 or 2 resident act during a scenario while the others observe     in a teletransmission closeby room. Debriefing follows the critical scenario in witch     resident are involved. The investigators are testing the effects of five minute of     conversational relaxation before the debriefing on the anxiety level and memorization of key     points each scénario on participant and observer.   "
62302|NCT02470117|"     This study evaluates the efficacy of alginate-based reflux suppressant and     magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the     participants will receive alginate-based reflux suppressant, while the other half will     receive magnesium-aluminium antacid gel.   "
62303|NCT02470104|"     The investigators hypothesize that children receiving human milk will maintain a greater     diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in     the blood compared with children not receiving human milk.   "
62304|NCT02470091|"     This phase II trial studies how well denosumab works in treating patients with osteosarcoma     that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal     antibodies, such as denosumab, may block tumor growth in different ways by targeting certain     cells.   "
62305|NCT02470078|"     The purpose of this study is to evaluate whether pharyngeal electrical stimulation in     addition to standard care can enhance swallowing recovery in severely dysphagic stroke     patients post extubation compared to sham treatment plus standard care.   "
62311|NCT02470000|"     Myofascial pain syndrome (MPS) is characterized by single or multiple trigger points (TrP) in     taut bands within the affected muscles. Chronic MPS over neck is prevalent and responsible     for markedly loss of work-day and a reduction of quality of life.      Intravascular laser irradiation of blood (ILIB) involves in vivo illumination of the blood by     low-level laser light through an optical fiber inserted in a vein. Researches disclosed that     ILIB reduced blood viscosity, enhanced erythrocyte deformity, and increased oxygen saturation     in blood. However, no research studies the effectiveness of ILIB to treat MPS.      Real-time sonoelastography (RTS) and shear wave velocity (SWV) are used to detect the     stiffness of skeletal muscles. RTS is displayed as a color-coded graphic to represent the     relative stiffness of structures. For a given material, faster SWV indicates the greater     stiffness. To our knowledge, only one research using RTS and SWV to study MPS.      To elucidate the effectiveness of ILIB to treat chronic MPS over neck, and the validity of     RTS and SWV for MPS, we conducted this study.   "
62312|NCT02469987|"     Double-blind, single-dose, three-treatment, parallel group design PK comparability study of     MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution     (bevacizumab).   "
62313|NCT02469974|"     To determine the safety of the approach of giving RUXOLITINIB before and after an autologous     stem cell transplant, as measured by graft failure or death.   "
62314|NCT02469961|"     The standard hospital procedure calls for the patient to undergo Interscalene block under     ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).     The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the     patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The     participant is then brought to the OR and prolonged sedation is initiated, randomly using     either Dexmedetomidine or Propofol.      The primary objective of the present study is to use Dexmedetomidine for sedation, and     compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for     this study.      Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and     reduced need for supplemental medication for sedation, compared to Propofol   "
62315|NCT02469948|"     Stroke may result in lower extremity spasticity, which interfere with motor voluntary     function and activities of daily living. Botulinum toxin type A (BTX-A) has been shown to     improve lower extremity spasticity of stroke patients. There are no researches to compare the     efficiency of BTX-A injection by different guidance methods in the deep muscles of lower     extremity for stroke patients. The aims of investigator's study were to compare the     effectiveness of BTX-A injection by different guidance methods (palpation of anatomical     landmarks, ultrasonography direct) in deep spastic muscles of lower extremity for stroke     patients with varus spasticity and spastic claw toes , and to study the correlation between     muscles spasticity and elastic properties by the sonoelastography/acoustic radiation force     impulse imaging and follow the change of elastic properties in spastic muscles after BTX-A     injection. We will enroll 80 hemiplegic stroke patients with varus spasticity / spastic claw     toes and duration more than 6 months. Under different guidance methods (palpation of     anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods),     BTX-A will be injected to the flexor digitorum longus and posterior tibialis muscles. If the     patients have moderate hallucis spasticity, flexor hallucis longus muscle will be injected.     The BTX-A dose is 50 units for each muscle. Outcome measures include Modified Ashworth Scale,     Brunnstrom stage, muscle power, range of motion, the visual analog scale of pain, Stroke     Impact Scale, Barthel index and lower extremity function tests, balance test, Goal Attainment     Scale, sonoelastography and acoustic radiation force impulse imaging. All the assessments     will be performed before BTX-A injection and followed up at 1 months, 2 months, 3 months and     6 months after injection. After performing all the assessments, investigator will investigate     the efficiency of BTX-A by different guidance methods.   "
62316|NCT02469935|"     Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the     detection of gallstones.      Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound     examination, were examined with a right upper quadrant ultrasound scan by a radiologist as     well as surgeon. The surgeons had undergone a four-week long education in ultrasound before     participating in the study. Ultrasound findings of the surgeon were compared to those of the     radiologist, using radiologist-performed ultrasound as reference standard.   "
62317|NCT02469922|"     Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during     radio-chemotherapy, on the loco-regional control after 2 years   "
62318|NCT02469909|"     The investigators propose to examine the feasibility and safety of immediate (single stage)     decannulation in adult patients in a controlled randomized trial. Patients who will be found     fit for decannulation after an otolaryngologist and intensive care specialist assessment will     be randomized into two groups: immediate decannulation and gradual decrease in cannula size.     Both groups of patients will be monitored after decannulation and in the outpatient clinic     for any complications following the procedure.   "
62319|NCT02469896|"     This research study is being done to find out if tocilizumab, also known as Actemra™, can     help with Amyotrophic Lateral Sclerosis (ALS). The investigators also want to find out if     tocilizumab is safe to take without causing too many side effects.      Currently ALS has no cure and 2 modestly effective treatment to slow the progression of the     disease. Although not the initial cause of ALS, the immune system plays a role in the death     of motor neurons. The immune cells that participate in this process are stimulated by a     substance called interleukin-6 (IL-6) whose effect is blocked by tocilizumab and thus, may     slow the death of motor neurons and slow the disease.   "
62320|NCT02469883|"     This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity     (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of     Sinotecean.   "
62321|NCT02469870|"     The evaluation of the program efficacy will be conducted via a randomized control study with     136 parents of children aged 3-8 who have autism. Investigators will test whether, compared     to a content comparison group (CC), administration of the APT program over a 3-week     intervention period (a) improves child behaviors, (b) increases perceived quality of life,     (c) decreases parental stress, (d) increases positive parenting practices, and (e) increases     parent knowledge of evidence-based support practices.   "
62322|NCT02469857|"     The purpose of this study is to determine whether AB103 is safe and effective in the     treatment of patients with necrotizing soft tissue infections receiving standard of care     therapy.   "
62345|NCT02469558|"     Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality.     Probiotic modulation of gut flora is a possible therapeutic mechanism.      The aim of this study is to investigate and compare thoroughly the effect of a multispecies     probiotic on glycaemic control, gut microbiota and gut permeability in patients with     metabolic syndrome and diabetes.   "
62346|NCT02469545|"     The aim of the study is to determine the influence of supplementation of probiotic     Lactobacillus Plantarum 299V vs. placebo of probiotic during antidepressant monotherapy with     SSRI (Selective Serotonin Reuptake Inhibitor) in patients with major depression.   "
62323|NCT02469844|"     Epilepsy is disabling and costly to patients and the health service. Nearly 400,000 people in     England suffer from epilepsy. About 40% of these patients are known to have seizures     predominantly in sleep. All seizures pose risk to the individual both physical and     psychological. Nocturnal seizures pose extra risk as the diagnosis may be missed or delayed.     Patients with nocturnal seizures are also thought to be at particular risk of sudden     unexpected death in epilepsy (SUDEP), especially if their seizures are unobserved. In     patients with poor seizure control, the risk of SUDEP has been found to be as high as 9 per     1,000 patient years. Previous studies show that many seizures are associated with changes in     the Autonomic Nervous System (ANS) tone. The ANS tone can be assessed using heart rate     variability parameters (HRV). A few studies suggest that ANS tone changes tend to precede the     onset of epileptic seizure related surface electroencephalographic (EEG) changes, suggesting     that ANS tone changes could be used in seizure alarm or intervention systems. This     prospective study intends to focus on seizures from sleep and study HRV parameters in the     immediate preictal state of the seizure and compare these with resting HRV parameters in the     same patient with the aim of finding HRV metrics which could help to identify the presence of     seizures in longterm electrocardiographic (ECG) recordings, or help predict seizure     occurrence, or provide information about the current risk of seizures. This study will also     investigate whether there are differences in the alterations of HRV parameters between     different forms of epilepsy and whether seizure lateralisation has an impact on HRV     parameters.   "
62324|NCT02469831|"     The investigators aim to investigate the differences between deep continuous muscle     relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in     respect to metabolic changes and respiratory mechanics.   "
62325|NCT02469818|"     Shoulder dislocation is a common clinical presentation in the emergency department,     comprising about 50 percent of all major joint dislocations. In the standart management of     shoulder dislocations physicians generally need to see pre and post reduction x ray graphics.     Ultrasonography is harmless way of evaluating shoulder and may be used in the management of     the shoulder dislocations instead of the x ray evaluations.   "
62326|NCT02469805|"     Four hundred and fifty women with mild male factor infertility will be divided into 3 equal     groups using computer generated random numbers: Group 1 will have up to 4 stimulated IUI     cycles, group 2 will have up to 4 unstimulated cycles, women who do not become pregnant after     the 4 cycles in groups 1 and 2 will be advised to have regular intercourse at the expected     time of ovulation. Group 3 will be the control group will be advised to have regular sexual     intercourse at the time of ovulation for 6 months   "
62327|NCT02469792|"     Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS     System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front     abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time     intraarticular ADRC administration (directly into anterior cruciate ligament). This is a     single arm study with no control. All patients receive cell therapy.   "
62328|NCT02469779|"     The goal of this research study is to learn how middle and high school students react to an     interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health     information online and what their preferences are when using ASPIRE.      Researchers hope to use the results of this study to design more effective online health     programs to provide middle and high school students with up-to-date information about tobacco     use, meditation, and general health and well-being.   "
62329|NCT02469766|"     This study will be conducted to compare the success and complication rates of ureteroscopy,     and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.   "
62330|NCT02469753|"     Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects     the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most     patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS.     Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling     inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic     arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural     progression of AS, some data even suggesting that it may accelerate the formation of     syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit     ossification phenomena independently of their anti-inflammatory properties, owing to a     specific action on bone formation via prostaglandin inhibition.      Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF     treatment, to prevent syndesmophyte formation in AS patients.   "
62331|NCT02469740|"     Usage of antiplatelet agents and cardiac procedures such as coronary angioplasty has     dramatically improved the morbidity and mortality associated with coronary artery disease. In     patients with a coronary stent, dual antiplatelet therapy is recommended. Aspirin is the main     antiplatelet agent used. For many years, clopidogrel was the second antiplatelet of choice.     Recent studies have revealed new antiplatelet drugs that can substitute clopidogrel, one of     which is ticagrelor. The degree to which ticagrelor reduced the overall mortality compared to     clopidogrel in the PLATO trial suggested that ticagrelor possibly has a pleiotropic effect     and that the reduction in mortality is not simply due to its antiplatelet effects. The     ticagrelor molecule resembles adenosine. Adenosine has been shown to be cardioprotective.      The aim of this project is to study the effects of ticagrelor on the arterial system using a     noninvasive method. The study will employ the measurement of peripheral endothelial function     of patients who undergo percutaneous coronary intervention who are on ticagrelor vs.     clopidogrel using a cross over trial design.   "
91698|NCT02085824|"     The purpose of this study is to determine which of the following drugs: enoxaparin,     dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).   "
62347|NCT02469532|"     This is a prospective, multi-center, observational registry to document the baseline, 24-hour     and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after     femoropopliteal angioplasty or atherectomy-based revascularization procedures.   "
62348|NCT02469519|"     This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal     steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor     premature rupture of the membranes.   "
62450|NCT02468193|"     The study aim is to investigate the efficacy and safety of Osilodrostat in patients with     Cushing's syndrome due to causes other than Cushing's disease in Japan.   "
62332|NCT02469727|"     The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit     Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit     mHealth app. The target population will be childhood cancer survivors 14-18 years old     recruited from Seattle Children's Hospital. For the intervention group, peer influences will     be engaged via a private, social network (e.g. a Facebook group) customized for survivors.     Measurements will be completed (1) at baseline, prior to randomization, and (2) during the     final week of the intervention period (follow-up measure). This study will provide initial     proof of concept and allow for further customization of the intervention for childhood cancer     survivors in anticipation of a future, larger proposal to study physical activity and related     outcomes over a multi-year period.   "
62333|NCT02469714|"     The health care needs of people with serious mental illness are exacerbated by ethnic health     disparities. Latinos with serious mental illness show significant health problems compared to     other ethnic groups. Therefore, this project is to develop a meaningful peer-navigator     program for Latinos with serious mental illness using community-based participatory research     (CBPR). Investigators are currently working with seven Hispanic/Latinos with a mental illness     that have formed a Consumer Research Team (CRT) that will guide this project. This project     will identify and define the problem by conducting a mixed methods research thru qualitative     interviews with various stakeholders defined by the investigator's CRT group. The qualitative     findings will then be cross-validated in a quantitative survey by 100 Hispanic/Latinos with     mental illness. This information will then be used to design an intervention using an     integrated care model for Peer-Navigators. Feasibility, accessibility , acceptability and     impact of the peer-navigator program will be then evaluated in a randomized control trial     (RCT) with 100 Latinos with serious mental illness who will complete measures of physical     health, mental health, service use and engagement at baseline, 4, 8, and 12 months.     Investigators expect to show physical health improvement with the greater engagement observed     in the peer navigator group. Investigators expect a similar improvement in mental health and     quality of life as physical health concerns are diminished.   "
62334|NCT02469701|"     Nivolumab releases the inhibition of the immune system against human cancers. Dramatic and     sustained activity has been observed in advanced lung cancer. Ablation may stimulate the     immune system by exposing new tumor antigens. Since tumors that express PD-L1 may be more     likely to respond to nivolumab, if ablation increases PD-L1 expression (which has not been     studied) this treatment may enhance the activity of nivolumab at both the treated site and in     other, non-treated, tumors. Ablation is already an FDA approved treatment for cancer.     Nivolumab was recently FDA approved for second line treatment of advanced squamous cell     NSCLC. The goal of the study will be to determine if the combination of nivolumab and     ablation has higher systemic activity than previously reported with nivolumab alone.   "
62335|NCT02469688|"     Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen     allergy   "
62336|NCT02469675|"     Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral     sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may     be an important method to improve functional recovery.      In this study, the investigators aim to use non-invasive magnetic and electrical stimulation     to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used     over the motor cortex (scalp). Two methods of electrical stimulation will be compared:     stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal     cord across the skin on the back of the neck. Several different combinations of magnetic and     electrical stimulation will be compared to find the conditions that best strengthen nerve     circuits between the brain and hands - Fire Together, Wire Together.      PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in     nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS     STUDY. If we see temporary changes in this study, then future studies would focus on how to     prolong that effect.   "
62337|NCT02469662|"     The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total     Elbow when used in primary or revision total elbow replacement.   "
62338|NCT02469649|"     Use of dipole density mapping to identify activation in complex supraventricular     tachycardias.   "
62339|NCT02469636|"     Use of dipole density mapping to identify activation in complex supraventricular tachycardias   "
62340|NCT02469623|"     Use of dipole density mapping to identify activation in complex supraventricular     tachycardias.   "
62341|NCT02469610|"     It is well known that chest surgery patients suffer from high level pain in the perioperative     period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain     control technique for thoracoscopic approaches is still under debate. One of the most popular     methods for pain control is these procedures is the Intercostal block. The Intercostal block     is usually based upon topical analgesic. In this study the investigators will try to examine     the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The     study is a prospective comparative study. The cohort will be divided into two groups. In the     control group patients will have Intercostal block after surgery and in the study group the     intercostal block will be given in the beginning of the surgical procedure. All other     analgesic treatment during and post-surgery will be the same in both groups. The study will     evaluate pain level in the days after the surgery, analgesic medication consumption and     relevant morbidity.   "
62342|NCT02469597|"     The purpose of this study is to assess if administration of an early single dose of a     diuretic (furosemide) to children with moderate to severe bronchiolitis can reduce     extravascular lung water in an effort to reduce respiratory rate, retractions, intubations,     and length of stay.   "
62343|NCT02469584|"     A descent of the anterior vaginal wall is the most common form of female pelvic organ     prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a standard     procedure, its exact steps are not well standardized.      We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the     strength and durability of AC      Objectives      The aim of this pilot study is to demonstrate the feasibility and complication rate of the     SSTAC and to assess the anatomical and functional outcomes after this method of cystocele     repair.   "
91725|NCT02085473|"     The aim of this study is to evaluate the pharmacokinetics and tolerability of tralokinumab     when delivered at different flow rates to healthy volunteers.   "
62349|NCT02469506|"     Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged     period of immobilization in otherwise healthy individuals. Long-term immobilization of the     lower extremity has shown to cause significant reductions in skeletal muscle mass, already     occurring during the early stages of disuse. Accordingly, feasible strategies for attenuating     this loss of muscle during disuse need to be pursued. Local neuromuscular electrical     stimulation (NMES) offers such a potential strategy but, as yet, remains untested during     prolonged muscle disuse in a clinical setting.      Objective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates     muscle loss during 2 weeks of unilateral ankle immobilization.      Study design: Randomized, parallel (two groups) study design.      Study population: 30 adults (18-65 y) with any form of closed ankle fractures needing     surgical treatment.      Intervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention.      Main study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area     (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content,     intramuscular triglyceride content and mRNA and protein expression of anabolic signaling     proteins.   "
62350|NCT02469493|"     The purpose of this study is to compare the preventive effect of electroacupuncture and sham     acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its     potential mechanism by using functional Magnetic Resonance Imaging (fMRI).   "
62351|NCT02469480|"     Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About     70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and     cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like     cancer often results in a reduced availability of iron for the body. In clinical practice     iron substitution is usually administered orally. Due to low resorption rates, frequent     gastric side effects and thus poor patient compliance a parenteral substitution seems to be a     better option in terms of efficacy. In the framework of a randomized multicenter clinical     trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron     substitution will now be conducted in order to identify the best treatment form for clinical     practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in     both treatment arms for effect comparison.   "
62352|NCT02469467|"     The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with     meal for 8 weeks to hemodialysis patients with hyperphosphatemia   "
62353|NCT02469454|"     This study aims to assess whether there is change in the growth and development of newborns     whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48     hours of delivery compared with those with standard implant insertion (6 week postpartum).   "
62354|NCT02469441|"     The aim of the study is to investigate if postoperative coffee intake decreases the time     until first bowel movement in elective colorectal surgery with primary anastomosis.   "
62355|NCT02469428|"     The purpose of this protocol is to assess whether epigenetic factors in healthy individuals     make a person more or less responsive to lung inflammation following ozone exposures.   "
62356|NCT02469415|"     The goal of this clinical research study is to learn if pacritinib, either alone or in     combination with azacitidine or decitabine, can help to control MDS.      The safety of this drug and drug combination will also be studied.   "
62357|NCT02469402|"     Formula contains significantly higher total protein concentrations than breast milk.     Therefore formula-fed infants have a significantly higher total protein intake in the first     few months compared to exclusively breast-fed infants.      The aim is to examine the nutritive efficacy and safety of a modified infant formula with a     reduced protein content and improved protein quality in a prospective, double-blind,     controled, randomized study. Primary outcome measures are weight gain and growth of young     infants under 12 weeks of dietary intake of the new infant formula. Metabolic effects of the     qualitative and quantitative changes in the protein content of the new formula will be     recorded. Two groups of healthy bottle-fed infants will be compared. The treatment group will     be fed for 3 months with an infant formula with decreased protein content. At the same time     the protein body of the new formula is modified by enrichment with bovine alpha-lactalbumin.      A control group receives a isocaloric conventional infant formula and a protein body     consisting of whey protein and casein in a ratio of 60:40, without specific accumulation of     alpha-lactalbumin over the same time-period.      A group of breastmilk fed infants will serve as a reference group. In regular anthropometric     controls growth and thriving of the study participants is documented and compared between the     different groups.   "
62377|NCT02469142|"     Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often     prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia     reparation, the recurrence rate were as high as 30%. In recent years, biological materials     especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the     infection, has become a research hotspot. In the project, the investigators try to address     the role of ADM in incarcerated inguinal hernia patients.   "
62378|NCT02469129|"     The purpose of this research study is to determine the feasibility of using positron emission     tomography (PET) imaging technology to image cancer with [18F]FluorThanatrace ([18F]FTT), a     new radioactive tracer compound that has been developed that images poly(ADP-ribose)     polymerase 1 (PARP-1) activity.   "
62366|NCT02469285|"     High consumption of red meat is related to cardiovascular diseases. Red meat containing more     unsaturated fat than normal red meat may have a beneficial impact on plasma lipid and fatty     acid profile in humans. Furthermore, consumption of red meat and especially processed red     meat is considered harmful to colon health. However, consumption of fruit and berries rich in     antioxidants and flavonoids may provide protection when red meat is consumed.      The study aims to answer whether the fatty acid profile of pork when modified towards more     unsaturated fat will affect plasma fatty acids and lipids in adult volunteers. The effects of     pork with a modified fatty acid content is compared with conventional pork with lower     unsaturated fat content. Fatty acid composition of pork is modified by altering the     composition of animal feed.      The other arm of the study investigates the effects of consuming berries together with red     meat on gut metabolism. The study focuses on how berries affect the formation of fecal     compounds known to be related to high red meat consumption, such as N-nitroso compounds.   "
62358|NCT02469389|"     The goal of this project is to evaluate an innovative psychosocial intervention package that     will incorporate evidence-based treatment strategies to target the affective-motivational     deficits, negative expectancies, and behavioral skills deficits that are central to the     maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community     Roles and Experiences) - will include strategies aimed at teaching Veterans with     schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure,     (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for     failure, and (4) perform skillfully in new social situations, all of which can impact     implementation of new skills and behaviors. Rather than develop a new set of intervention     strategies, the investigators will include within EnCoRE evidence-based strategies for these     treatment domains. In addition, the investigators will collect qualitative information both     from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to     participation in EnCoRE, as well as from a sample of mental health providers who work with     Veterans with schizophrenia and negative symptoms, in order to inform a larger scale     implementation trial should EnCoRE prove effective here.   "
62359|NCT02469376|"     Arterial and venous thrombi play an important role in various vascular diseases such as     myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These     thromboembolic disorders are the leading causes of morbidity and mortality worldwide. A     non-invasive method for the quantitative and effective detection of thrombi in the whole body     has not yet been established. In spite of the available techniques, 30% to 40% of ischemic     strokes cryptogenic (undetermined cause, the source of thromboembolism is never     identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic arch     or intracranial arteries. A plaque in the arch or other large vessels could be an important     source of cryptogenic strokes, however, are those difficult to detect by routine methods. The     approach of thrombus targeted molecular imaging could identify potentially troublesome     plaques early on before they become a dangerous rupture. The hypothesis is that the     radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET) can     be made visible. The primary goal is the potential applicability of the substance as a PET     tracer for diagnosing thrombi.   "
62360|NCT02469363|"     During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to     an increase in the plasma catecholamine concentrations due to the activation of the     sympatho-adrenal system. Prevention or reduction of this increment is important for     hemodynamic control. Therefore, various methods such as providing adequate depth of     anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative     laryngoscopy devices and techniques have recently started to be used.      In this randomized single blind study, the aim is to compare the hemodynamic responses of     four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac     videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.   "
62361|NCT02469350|"     In this study the investigators aim to assess the feasibility and acceptability of a serious     game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease     previously operated for deep brain stimulation of the sub thalamic nucleus.   "
62362|NCT02469337|"     The aim of the study is to investigate whether preoperative interventions such as     carbohydrate drinks, Dichloroacetate and exercise would inhibit or reverse the changes in     molecular mechanisms regulating muscle carbohydrate oxidation and postoperative muscle     insulin resistance in patients undergoing major abdominal surgery.   "
62363|NCT02469324|"     The current study is a two condition randomized controlled trial for women who are pregnant,     interested in becoming pregnant, or pregnant within the last year. The conditions include a     brief Cognitive Behavioral Therapy and a brief Compassionate Mind Training intervention.     Participants in each condition will complete a 45 minute didactic exercises and readings     followed by an email with exercises to continue practicing for a total of 2 weeks. After 2     weeks, participants will receive post-baseline assessment measures (e.g., depression,     anxiety, affect, self-reassurance, self-attacking, self-criticizing, self-compassion).     Participants will be recruited through a women's clinic in the United Kingdom by Michelle     Cree, M.S. and through listservs by Yotam Heineberg, Psy.D. The researchers will also invite     individuals in their social networks through email and through the Amazon Mechanical Turk     System.   "
62364|NCT02469311|"     Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a     standard-of-care group who only had a bath with antibacterial soap and water. Both groups     received standard infection control practices during admission.   "
62365|NCT02469298|"     Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient     study evaluating the safety, tolerability and clinical effect of danirixin or danirixin +     oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in     otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a     selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits     neutrophil transmigration and activation to areas of inflammation. The study endpoints are     intended to test the hypothesis that inhibition of neutrophil activation by approximately     50-60% (as previously measured by cluster of differentiation [CD11b] expression in response     to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not     impact safety parameters or worsen clinical manifestations of disease, disease-related events     of interest, or viral load, and may possibly improve these parameters when administered     within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the     safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX]) alone or in     combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated     influenza prior to future evaluation in hospitalized patients with complicated influenza. The     primary objective is to assess safety and tolerability of DNX with and without a     neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital     signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an     assessment of disease related events (DREs) of interest and associated antibiotic use. The     Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document     patient reported outcomes (PROs). The screening visit in Australia will be composed of a     pre-screen for influenza infection with an influenza rapid antigen test followed by a screen     for the remaining eligibility criteria for those subjects with a positive result on the     influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health     Private Limited.   "
62379|NCT02469116|"     In this study the investigators will be using an AUC of 6 based on creatinine clearance using     the Carboplatin dosing formula used for Gynecologic Oncology Group protocols.      Given that myelosuppression was significant using the docetaxel dose of 75 mg/m*2 in the     SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted.     The expectation would be that patients will be able to receive their cycles in a more timely     fashion, with less delays, thereby allowing for improved outcomes and decreased     hospitalizations due to myelosuppression.   "
62367|NCT02469272|"     Nonalcoholic steatohepatitis (NASH) is common, may progress to cirrhosis and is predicted to     become a leading indication for liver transplantation in the near future. Though often     associated with obesity and the metabolic syndrome, our current understanding of disease     development is limited and there are few therapeutic options. Imbalance of gut bacteria is     suspected to play a key role driving the progression of fatty liver disease and there is hope     manipulation of these bacteria may be beneficial. This study will determine if fecal     microbiota transplantation, using stool from lean donors, is an effective and safe treatment     for NASH.   "
62368|NCT02469259|"     This study will investigate the effects of oxytocin on alcohol-related behaviors, social     abilities, and physiological startle responses in healthy individuals and patients with     posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) using a randomized,     placebo-controlled, dose-tiered, between-subject study design. Specifically, the     investigators will determine if intranasal administration of a single dose of the pro-social     neuropeptide oxytocin decreases alcohol-related approach bias and cravings, enhances social     abilities, and decreases physiological hyperactivity. The investigators will also determine     the optimal dose to achieve these effects and will explore psychosocial predictors of     responses to oxytocin. The proposed work has the potential to yield a novel pharmacological     treatment for AUD and PTSD, both leading causes of disability in the US Military for which     currently available treatments are inadequate.   "
62369|NCT02469246|"     This study will evaluate the efficacy, safety, and tolerability of switching     abacavir/lamivudine (ABC/3TC) to emtricitabine/tenofovir alafenamide (F/TAF) versus     maintaining ABC/3TC in HIV-1 infected adults who are virologically suppressed on regimens     containing ABC/3TC.   "
62370|NCT02469233|"     Mental illness is often severe, chronic and difficult to treat. The sleep disturbance     commonly experienced by individuals with a severe mental illness reduces capacity to function     and contributes to key symptoms. This study seeks to determine if an intervention to improve     sleep can improve functioning and reduce symptoms and impairment. We will conduct this study     in community mental health centers to ensure that the results contribute to closing the     worrisome gap between research and practice and to ensure that the findings are generalizable     to the real world.   "
62371|NCT02469220|"     The main objectives of this trial are to examine the effect of a low FODMAP diet on gut     microbiota, inflammatory markers, gastrointestinal symptoms and quality of life in patients     with ulcerative colitis. Furthermore the trial will explore if the response towards a low     FODMAP diet can be predicted by a patients initial gut microbiota profile. The patients will     be randomized to an open parallel-group intervention of six weeks duration with intake of     either a low FODMAP diet or a control diet (habitual diet).   "
62372|NCT02469207|"     This study aims to use tissue from deceased organ donors to investigate organ physiology,     developmental biology, as well as the development of future regenerative cellular therapies.     It will investigate function and immune response to stem cells as well as their generation     from adult cells and generation of induced pluripotent stem cells (iPSCs).   "
62373|NCT02469194|"     In general, the toxicity of radiation therapy and chemotherapy exhibits a strong     dose-response relationship. However, patients receiving similar doses still exhibit a range     of toxicity responses due to a variety of factors, including comorbid conditions, disease     (cancer) specific factors, and inter-individual genetic variation. A very small percentage of     patients experience side effects that are either extremely severe or extremely mild compared     to the majority of patients for the dose of radiation or chemotherapy given. Currently, the     reasons for this are not entirely clear, but likely relate to patient specific factors such     as immune response, cell/tissue repair capacity and other factors that fundamentally rely on     rare genetic variations at loci involved in these responses. For example, patients with     homozygous deletions in DNA damage response genes such as ATM are uniquely sensitive to DNA     damaging agents. Many patients with severe, homozygous mutations in such genes have other     sequela that lead to medical recognition of the syndrome prior to therapy. The investigators     hypothesize that patients with unusually severe toxicity from therapy that do not exhibit     classical signs of homozygous mutation syndromes are heterozygous for nonfunctional or     hypofunctional alleles at these loci, such that the defect is only uncovered under the     relatively acute, severe stress on that pathway by radiation or chemotherapy. Conversely,     patients with very mild reactions could exhibit rare variants/combinations of variants that     make them uniquely resistant to chemotherapy or radiotherapy toxicity.      The purpose of the study is to better understand these mechanisms with the eventual goal of     developing predictive markers that will allow us to help individually tailor cancer therapy     is in future patients. Will accomplish these goals by studying a variety of factors from a     single vial of blood. These will include circulating proteins and hormones, circulating cells     and the levels and sequences of white blood cell DNA or RNA using a variety of techniques     including but not limited to determination of cytokine/hormone levels, proteomic analysis,     immunocytochemical assays, whole exome sequencing and qPCR.   "
62374|NCT02469181|"     The purpose of this study is to evaluate the impact of ERT on LV diastolic function and flow     in patients with Fabry's cardiomyopathy using diastolic stress echocardiography, LV vortex     flow and CMR.   "
62375|NCT02469168|"     The purpose of this investigation is to evaluate the safety, tolerability, preliminary and     long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell)     combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate     INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.   "
62376|NCT02469155|"     The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind,     parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with     schizophrenia having an acute exacerbation of psychosis.   "
62380|NCT02469103|"     The purpose of this study is to investigate the accuracy of second generation colon capsule     (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using     conventional endoscopy as the gold standard.   "
62382|NCT02469077|"     Chronic Pain (CP) management has increasingly utilized long-term opioid analgesic therapy, a     change associated with increased opioid abuse (via greater exposure in vulnerable     individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in     opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic     high-dose opioids are sorely needed. This project will test the novel hypothesis that     effective pain relief can be achieved at lower opioid analgesic doses by increasing levels of     endogenous opioids (EOs).   "
62393|NCT02468934|"     The purpose of this study is to determine if electrical stimulation (small levels of     electricity) can safely and effectively reduce pain following total knee replacement. This     study involves a device called the SPRINT System. The SPRINT System delivers mild electrical     stimulation to nerves in the leg that received the knee replacement. The SPRINT System     includes a small wire (called a lead) that is placed through the skin in the upper leg. It     also includes a device worn on the body that delivers stimulation (called the SPRINT     Stimulator).   "
62383|NCT02469064|"     Respiratory muscle training (RMT) is considered a therapeutic strategy to improve respiratory     muscle strength in mechanically ventilated (MV) patients and facilitates ventilator weaning.     RMT aims at improving strength and endurance of respiratory muscles . However, scarce     research exists regarding evaluation of RMT in MV patients and additionally studies differ in     methods, RMT protocols and subjects included. There are not reports about Colombian studies     evaluating RMT effects on MV patients. The aim of this study is to evaluate the effectiveness     of respiratory muscle training in increasing respiratory muscle strength and improving     weaning outcomes in MV patients who required ventilatory support for more than 48 hours at an     Intensive Care Unit of an IV level Hospital in Cali during the period 2014-2015   "
62384|NCT02469051|"     This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary     CT angiography.   "
62385|NCT02469038|"     While peripheral venous cannulation is among the most common procedures performed in clinical     settings, it is estimated that PIV insertion fails for 6 million patients annually. Failure     to establish peripheral venous access in the emergency department is a costly problem,     leading to delays in diagnostics and treatment and requiring alternative sites for vascular     access. These alternative methods can lead to higher complications rates, decreased patient     satisfaction, and increased utilization of nursing and physician time. Complications from PIV     failure also pose a significant financial burden to the healthcare system.      Ultrasound guidance has been shown to greatly improve the process of localizing vessels for     cannulation. In a healthcare climate that is increasingly focused on outcomes and     cost-effectiveness, ultrasound-guided peripheral venous cannulation has become not only a     viable but often the preferred method in patients with difficult venous access. Nevertheless,     studies to date on ultrasound-guided peripheral venous cannulation have revealed some     shortcomings, such as premature failure and low first attempt success rates.      The purpose of our study is to assess whether ultrasound-guided cannulation of a AccuCath     catheter, which has a coiled tip guidewire, is superior to ultrasound-guided cannulation of a     conventional peripheral IV catheter across clinical outcomes relevant to the emergency     department setting.   "
62386|NCT02469025|"     Lower limb osteoarthritis is a major health problem in the westernized countries. The current     gold standard treatment is joint replacement. However clinical guidelines recommend physical     therapy as first option for these patients. Manual therapy has reported good reports in     function, range of motion and pain in patients with hip osteoarthritis. The main aim of this     study is to test the effects of a manual therapy protocol based on manual traction     mobilization of the hip joint in an end range position and compare them with the effects     achieve with the same protocol based on manual traction mobilization of the hip joint in a     resting position. The investigators will use the caudal traction mobilization described by     Kaltenborn. The study will test the effects of both treatments in passive range of motion,     function and pain after three weeks of treatment, three weeks after finalizing the treatment     and six weeks after.   "
62387|NCT02469012|"     The present study evaluates neurocognitive performance as well as measures of mood, quality     of life, and fatigue in patients with chronic hepatitis C infection. In a prospective     longitudinal study design, included patients are monitored before, during, and in the     long-term follow-up of interferon-free antiviral treatment (Sofosbuvir +/-Daclatasvir +/-     Ribavirin or Sofosbuvir/Ledipasvir +/- Ribavirin). Main study goals are to compare post     therapy results of sustained virologic responders to corresponding pretreatment values as     well as to historic interferon-treatment patients without virological response. It is     expected that HCV-associated neuropsychiatric symptoms and neurocognitive impairment is - at     least in part - reversible by the successful application of modern IFN-free antiviral     medication.   "
62388|NCT02468999|"     Research in animals and first experiments in humans indicate that insulin action in the brain     regulates peripheral insulin sensitivity. One major organ might be the liver. Previous     studies in humans showed that the human brain is an insulin sensitive organ in lean but not     in overweight/obese persons. Therefore, this study will include lean versus overweight/obese     persons.      In this study, insulin action will be introduced by intranasal insulin administration in lean     and overweight humans. As a control, placebo spray will be administered. To mimick the known     spill over of small amounts of intranasal insulin into circulation, a small bolus of insulin     will be administered over 15 minutes following placebo spray application.      Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp     and glucose uptake and endogenous glucose production will be assessed by tracer dilution     technique. Autonomous nervous system activity will be addressed by heart rate variability.     Involved brain areas will be addressed by fMRI before and after nasal insulin application.   "
62389|NCT02468986|"     Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is not     influenced by traditional risk factors. Blood vessel dysfunction has been associated with     heart disease and complications such as heart attack. The vessel dysfunction is thought to be     mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen on     ultrasound that improves after medications are given.      The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid     arthritis to determine if there is a difference in the protein expression in the cells that     line the blood vessels compared to healthy people.   "
62390|NCT02468973|"     Medical students from zefad medical school volunteer to assist patients with chronic diseases     to make lifestyle changes.      Each student will work closely with a family doctor who finds patients who need and want it     accompanied by a change he introduced them and guide him on health status, medication and     change the desired objectives.      In the program students will receive guidance on healthy lifestyle and support a patient to     perform health changes in theoretical and practical. Training sessions will be held     periodically, close supervision and guidance, counseling and cross-fertilization and updates     from the scientific literature.   "
62391|NCT02468960|"     Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons     before implantation of BVS (Bioresorbable Vascular Scaffold).      Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of     BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly     reduced. This is expected to result in better short- and long-term outcomes.   "
62392|NCT02468947|"     The investigators want to assess the effectivity of different sample volumes in blood     cultures.   "
62395|NCT02468908|"     This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple     ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male     and female subjects (on non-child bearing potential) will be enrolled to investigate single     inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose     levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered     once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is     the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The     Clinical trial will involve 42 healthy participants. The trial is expected to last     approximately 4 months.   "
62396|NCT02468895|"     Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be     recruited. Patients will be approached, consented, have baseline demographics, diagnostics     and disease activity measures recorded, and blood taken. The collection of data and     biological material will mirror usual clinical practice as far as possible. Subjects will     ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures     recorded and questionnaires completed.      In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be     collected for research purposes to measure a number of biomarkers for the assessment of     diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy     will be performed at baseline, and a further biopsy offered at 6 months to assess treatment     response. A magnetic resonance (MR) muscle protocol will also be performed as per usual     clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be     repeated at 6 months. An existing electronic database entry system will be used for data     entry and capture on an anonymised basis.      The study will thus be based around diagnostic evaluations and outcome measures to improve     quality of care in IIM.   "
62397|NCT02468882|"     Population studies associate a higher intake of cruciferous vegetables with a reduced risk of     cancer. Studies identified PEITC and several active isothiocyanates in watercress extract     that may have significant anticarcinogenic activity. Potential anticarcinogenic mechanisms     include: preventing carcinogen activation by inhibiting phase I enzymes such as cytochrome     P450s, by increasing cells' resistance through detoxification/antioxidant enzymes, by     inhibiting cell cycle progression and/or by inducing apoptosis.      These findings are justifiably interesting for the primary care setting and cancer primary     prevention. Yet, these cellular effects of watercress supplementation may further prove     useful in the modulation of cancer progression and disease recurrence. The present clinical     trial of nutritional supplementation in cancer, intends to further explore the effects of     therapeutic diets supplemented with nutraceuticals via watercress that may prove useful in     DNA damage modulation, as well as in the global disease prognosis.   "
62398|NCT02468869|"     The goal of the proposed study is to assess the potential of information structuring for     improving discharge communication. Specifically, the investigators aim to examine the     advantages of an information-structuring skills training for physicians (compared to an     emotion skills training) on discharge communication and associated patient outcomes, such as     patients' information recall and adherence to physician recommendations. The investigators     hypothesize that patients receiving structured discharge information from their trained     physicians will be able to recall more information and show higher adherence to     recommendations relative to controls (i.e., patients receiving discharge information from     doctors trained in emotion-handling skills).   "
62399|NCT02468856|"     Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and information     processing. Chronic effects include metabolic dysfunction, cardiovascular disease and cancer.     Sleep deprivation affects quality of life when it causes errors in judgment, whether these     occur behind the wheel of an automobile or in a hospital. Armodafinil, a non-amphetamine     wakefulness promoting medication, indicated for excessive sleepiness associated with     obstructive sleep apnea, narcolepsy, and shift work sleep disorder is used to mitigate the     effects of sleep deprivation.      This study will characterize the effect of armodafinil on driving simulator performance. The     effects of armodafinil compared to placebo will be studied in a double blind crossover trial     involving 10 healthy subjects with serial assessments at baseline and after extensive sleep     deprivation. Using simultaneous electroencephalogram (EEG) recording during simulated driving     and neurocognitive assessments of vigilance, the relationship between brain activity and     cognitive performance will be established.   "
62414|NCT02468661|"     The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended     phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study,     and to assess the anti-tumor activity and safety of INC280 alone, and in combination with     erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients     with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with     acquired resistance to prior EGFR TKI.   "
62457|NCT02468102|"     This prospective cohort study will provide information about:      Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first     time compared to patients who are prescribed standard of care for the first time.      The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the     occurrence of non-infective liver disease.   "
62400|NCT02468843|"     Deep brain stimulation (DBS) is an effective surgical therapy for select Dystonia patients     who are refractory to medications or who have generalized symptoms (e.g. patients with     Early-Onset Primary Dystonia(DYT1) mutations and other dystonia subtypes). DBS patients     typically experience significant improvement in disabling symptoms; however, detailed     programming is always required, and stimulation-induced side effects commonly emerge.     Clinicians may empirically vary voltage, pulse width, frequency and also the active contacts     on the DBS lead to achieve observed optimal benefits.      The majority of DBS patients undergo repeat surgeries to replace the implantable pulse     generator (IPG) every 2.5 to 5 years. It has been demonstrated that, in dystonia patients,     that higher settings are required for adequate symptomatic control, and that neurostimulators     have a considerably shorter life when compared to neurostimulators from patients with     essential tremor or Parkinson's disease. Additionally, several smaller studies have suggested     that alternative pulse stimulation properties and pulse shape modifications can lower IPG     battery consumption.      Newer patterns of stimulation (regularity of pulses and shapes of pulses) have not been     widely tested in clinical practice, and are not part of the current FDA device labeling.     Novel patterns of stimulation do however, have the potential to improve symptoms, reduce side     effects, and to preserve the neurostimulator life.      The current research proposal will prospectively study biphasic pulse stimulation paradigms     and its effects on dystonic symptoms. The investigators aim to demonstrate that we can tailor     DBS settings to address dystonia symptoms, improve the safety profile, characterize distinct     clinical advantages, and carefully document the safety and neurostimulator battery     consumption profile for biphasic stimulation.   "
62406|NCT02468765|"     Cognitive and emotional disorders are often encountered in multiple sclerosis (MS) cases:     depressive and bipolar disorders are twice as frequent as in general population.      Cognitive disorders, (particularly attention and dysexecutive disorders), appear in early     stages of the disease's evolution, in cases of lightly or moderately disabled patients, with     a recent evolution, with a minor form of the disease, even in Clinically Isolated Syndromes     (CIS). Emotional disturbances are essentially linked to mood disorders of depression-type.      Last ten years, emotional processing in multiple sclerosis cases was investigated in various     trials, especially regarding the recognition of facial and emotional expressions. These     studies reported data, supporting an impairment of the perception of emotion, particularly     those with negative valence.      The objective of this study is to investigate the link between recognition of facial and     emotional expressions and depression in multiple sclerosis cases.   "
62407|NCT02468752|"     Primary objective:      - Assessment of venous gas emboli load post diving when breathing normobaric oxygen compared     to air.      Secondary objectives:        -  Assessment of flammatory activity in blood post diving        -  Assessment of fluid markers of central nervous system injury in blood post diving        -  Assessment of DCS frequency        -  Comparison of TCD and TTD consistency in venous gas emboli measurements   "
62408|NCT02468739|"     Monosialotetrahexosyl ganglioside (GM1) protect breast cancer patient from taxanes-related     neurotoxicity.   "
62409|NCT02468726|"     In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be     free of solid matter so the endoscopist has a clear view, increasing the chance of detection     of abnormalities. This is achieved through the use of bowel cleansing preparations, which are     administered prior to the procedure. Enemas are the preferred method as they clear the lower     bowel more quickly than oral formulations and do not require dietary restrictions.      The medical device being tested in this clinical investigation is NER1008, an enema which     contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the     water content in the rectum and sigmoid colon, consequently increasing stool volume,     resulting in rectal distension and subsequent distal colon emptying. The increased colonic     luminal content stimulates the motility, propulsive transportation and rectal evacuation of     the distal colon content.      This study is designed to assess the performance of NER1008 in bowel cleansing and compare     this with the performance of Fleet® enema, which is widely used for this purpose.   "
62410|NCT02468713|"     Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and     docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil     emulsions have not been commercially available until very recently. The Objective of this     study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total     parenteral nutrition in healthy Korean male subjects. This study is designed as a randomized,     open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected every 1 hour     from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and     insulin.   "
62411|NCT02468700|"     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone,     0.4mg) depot when placed in the canaliculus of the eyelid in subjects who exhibit signs and     symptoms of dry eye disease.   "
62412|NCT02468687|"     The study will evaluate if the N-methyl-pyrrolidone (NMP) can be safely administered to     humans at doses, which induce measurable immunological and anti-tumour effects in patients     with myeloma who are resistant to or intolerant of lenalidomide and bortezomib.   "
62413|NCT02468674|"     A 24-week off drug extension parallel group study assessing the durability of effect on     skeletal muscle strength and function following a 6-month double-blind placebo-controlled     study evaluating bimagrumab in older adults with sarcopenia   "
62452|NCT02468167|"     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection     versus balloon-occluded retrograde transvenous obliteration in the management of acute     gastric bleeding.   "
62416|NCT02468635|"     Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not fully     reversible airway, where the severity of the disease and the prognosis is not determined     solely by changes in lung function. Pulmonary rehabilitation is a multidisciplinary program     of care for patients with chronic respiratory diseases, individually designed to optimize     physical and social performance and autonomy of these patients, promoting improvement in     functional exercise capacity, quality of life, reducing dyspnea, frequency and duration of     hospitalizations and reduce the frequency of exacerbations of the disease. The overall     objective of the research is to evaluate the effects of pulmonary rehabilitation program on     exercise capacity, lung function, quality of daily life and reduction of dyspnea in patients     with COPD. A study type randomized, open-label trial following the recommendations of the     CONSORT (Consolidated Standards of Reporting Trials) will be held. The study will be     conducted at the Clinic Physiotherapy Course of the School with a sample of 58 patients. The     intervention will be performed sessions three times a week for 16 weeks (8 weeks for     assessment and 8 weeks for adaptation and (pulmonary rehabilitation training). The PR     (pulmonary rehabilitation) will last 60-120 minutes each.O group A (control) will receive     treatment of traditional pulmonary rehabilitation and without resistive training for upper     limb (UL) and group B will receive the same treatment control with additional training of     upper limb strength.   "
62417|NCT02468622|"     Despite the fact that migraine is a common disorder, the pathogenesis is still not fully     elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous     migraine-attacks will enhance our understanding and may point to new targets for drug     development.   "
62418|NCT02468609|"     To investigate the diagnostic value of ultralow-dose computed tomography in the detection of     pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to     standard-dose-CT.   "
62436|NCT02468375|"     The purpose of this study is to measure the treatment satisfaction after switching to     mirabegron in patient with Overactive Bladder(OAB) who were unsatisfied with efficacy of     antimuscarinic therapy or adverse event.      Patient will take the mirabegron 50mg/day for 12 weeks, and the satisfation of the therapy     will be measured with Treatment Satisfaction Questionnaire(TSQ), Global Response     Assessment(GRA), OAB-q short form, OAB Symptom Score and Willingness to continue Questions.   "
62437|NCT02468362|"     Through a double blinded study, patients with low rectal cancer will be randomized into two     equal groups to compare between the 5 year disease free survival as a primary outcome     measure.   "
62419|NCT02468596|"     The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal     excitability, using computerized analysis of the muscular response of musculus abductor     pollicis brevis, to series of electrical stimulations of the median nerve.      Because of its high sensitivity to small changes in axonal excitability, QTRAC may help     improve the follow-up of patients suffering from peripheral neuropathy caused by     anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability     is early affected in this disease.      The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with     QTRAC results in healthy persons (matched for sex and age).      A secondary aim is to determine whether or not the disease's clinical severity (measured by     quantitative clinical scores) is correlated with the results of the QTRAC and could be     predicted by a model based on the several parameters measured in the QTRAC exploration.      100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological     examination with clinical scoring. The results will be compared with data (matched by sex and     age) from the reference database on healthy subjects, that is provided with the QTRAC     software.      The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy     patients, and that the clinical severity of the disease can be predicted by a combination of     QTRAC-measured parameters.   "
62420|NCT02468583|"     This study is a double-blind, randomized, parallel group, proof of concept study comparing     FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with     post-traumatic osteoarthritis of the knee.   "
62421|NCT02468570|"     Phase 3 substudy enrolling approximately 100 subjects, aged ≥ 18 to ≤ 70 years old, with PKU     who are concurrently participating in the 165-302 study.   "
62422|NCT02468557|"     This study will evaluate the safety, pharmacodynamics, pharmacokinetics (PK), and efficacy of     single agent idelalisib and in combination with chemotherapy in adults with metastatic     pancreatic ductal adenocarcinoma. This study will also define the the maximum tolerated dose     (MTD) of idelalisib in combination with chemotherapy.   "
62423|NCT02468544|"     This is an open-trial pilot study in which adult methadone maintenance treatment patients who     are living with HIV but are not engaged in HIV primary care (i.e., missed appointments,     non-adherence to medication) will be recruited to participate in a HIV primary care     engagement study. The purpose of this study is to develop and test the feasibility and     acceptability of a mobile phone-based health (mHealth) text messaging intervention to improve     engagement in HIV primary care among substance abusing populations with HIV.   "
62453|NCT02468154|"     Assess whether by placing a custom made splint with heel in the immediate postoperative     period until removal of the cast, the rate of pain, the number of healthcare interventions to     maintain the off-loaded heel position and number of pressure sores in children wearing lower     limb plaster casts is reduced.   "
63690|NCT02451969|"     The purpose of this study is to evaluate the immunogenicity and safety of an investigational     23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly.     The control vaccine is a commercialized 23-valent PPV.   "
62424|NCT02468531|"     Acute lung injury (ALI) is the vital complication of Stanford type A aortic dissection. It is     confirmed that Xenon has the significant protective effect on important organs and has no     suppression on the cardiovascular system. Furthermore, our earlier trial has already     clarified that static inflation with 50% Xenon during cardiopulmonary bypass could attenuate     ALI for Standford A acute aortic dissection. However the protection effect was restricted for     the limited time. Aimed to enhance the protection effect of Xenon, we designed this     randomized trial that anesthesia with 50% xenon one hour before and after CPB and pulmonary     static Inflation with 50%,75% and 100% Xenon during CPB respectively.   "
62425|NCT02468518|"     This study will be conducted to observe any change in aerobic bacterial pattern on the skin     of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.   "
62426|NCT02468505|"     Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual     impairment face a fairly unique set of challenges as they transition out of secondary school.     These students are often quite capable of succeeding in higher education and many of them     have interest in pursuing advanced degrees, but the nature of their disability and associated     deficits (e.g., poor time management and poor self-regulation) may impede success.     Individualized, appropriately timed, and developmentally sensitive transition and support     services may promote optimal outcomes for these young people. The goal of this project is to     develop a comprehensive program to promote successful transition of students with ASD from     high school to post-secondary education.   "
62427|NCT02468492|"     The purpose of this study is to evaluate the affect that platelet rich plasma has on the     molecular an cellular functioning of the knee joint.   "
62428|NCT02468479|"     Chest/abdominal wall varices and spider nevi are two common presenting signs of liver     cirrhosis. Their prognostic values remain unclear.   "
62429|NCT02468466|"     The purpose of this study is to examine the effectiveness of a community-based     depression-screening program for suicide prevention among middle-aged adults, the     investigators conducted a quasi-experimental intervention study, using a parallel cluster     design with communities at municipal level as the unit of allocation and individuals as the     unit of analysis.   "
62430|NCT02468453|"     This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of     vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the     US and worldwide. The purpose is to collect data from the use of VELOS.   "
62431|NCT02468440|"     Treatment care of end-stage renal insufficiency is an important public health issue. The     balance between patients waiting for a kidney transplant and available graft raises     questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in     this trial patients will experiment an educational therapy's program as soon as they register     on the transplant list.   "
62432|NCT02468427|"     In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal     teaching using a Training Video for learning how to perform an assisted delivery by vacuum     extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills     (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training     is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.   "
62458|NCT02468089|"     A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting     to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to     treat SBP will be included and randomized into two treatment groups.      Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.   "
62441|NCT02468310|"     Introduction Maternal and neonatal mortality continue to be to be prominent public health     issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of     Millennium Development Goals (MDG) 4 & 5. Studies have identified poor quality of maternal     and child healthcare as a major challenge to the prevention of neonatal and maternal deaths.     Effective interventions are required to make significant inroads in these areas.      Objective To evaluate the effect of a SMS text messaging intervention to support clinical     decision making by frontline health care professionals on neonatal and maternal mortality.      Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana,     involving 8 intervention and 8 control districts. The intervention consists of text messaging     of standard protocols for maternal and neonatal care to front line health care providers in     the region. A total of 17,040 pregnant women who are receiving care (including antenatal,     delivery and post-natal) at any of the hospitals in the selected districts in the region will     be monitored through monthly aggregate data on outcome measures such as neonatal and maternal     deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth     weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this     study. Also, a quality of care assessment in four sampled districts to measure adherence to     the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software     version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to     explore baseline characteristics of study groups while logistic regression will be applied to     evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05     will be used.      Expected outcome We hypothesize that the intervention will improve both maternal and neonatal     service delivery and health outcomes in the intervention areas.   "
62442|NCT02468297|"     This randomized , double-blind, parallel-arm clinical trial was designed to study the     efficacy and safety of the Electronic Acupuncture Shoes treatment on chronic low back pain     patients.      Chronic low back pain patients, aged 20-60, of both gender were recruited. As the primary     outcome measure to assess the efficacy, 0-10 numerical rating scale was used. Secondary     outcome measure included the speed of pain-relief.      The number of samples in the experimental group and the control group ratio of 1 : 1 , is     expected to total effective sample number is 60 . Experimental group will receive a six-week     Electronic Acupuncture Shoes treatment and a week back to the clinic three times , subject     to a total of 18 treatments , each course of about one hour . Subjects will take NSAID     placebo in the first week of the course of treatment . After the second week of NSAID placebo     on disabled.      Control subjects will also accept the six- week treatment , control subjects will be equally     back to the clinic three times a week , each group will be given to the subject of one hour     each shoe pseudo electrotherapy treatment group and control group run by entering from the     test day in the first week of the course , each taking ibuprofen 400mg, taken three times a     day , the second week after the NSAID drugs on disabled.   "
62443|NCT02468284|"     The purpose of this trial is to look at how much a new trial drug get into body, such as when     the drug concentration in your body reaches peak and how high the peak value is.   "
62444|NCT02468271|"     There is an increasing demand for researchers and regulatory bodies to use robust outcome     measures in clinical trials which have evidence of validity, reliability, and responsiveness.     There is currently little agreement on the core clinical endpoints that should be used in     bronchiectasis. The importance of improving endpoint outcome measurement is well recognised     and groups in other conditions have focused on activities to achieve consensus on a core set     of outcomes for clinical trials. The Bronch-UK collaboration has explored the current     evidence for clinimetric properties of commonly used outcome measures in bronchiectasis (e.g.     forced expiratory volume in one second [FEV1], health related quality of life [HRQoL], and     pulmonary exacerbations). The results of this extensive rigorous literature review of 68     papers clearly demonstrate that whilst there was good evidence for validity for key outcome     measures in bronchiectasis there is little information available on their reliability (during     periods of clinical stability) or response to treatment (effect sizes).      The aim of this study is to explore the clinimetric properties of a range of outcome     measures, in order to make recommendations for their use in clinical trials in     bronchiectasis.   "
62445|NCT02468258|"     Patients & Methods: Eighty infertile women were randomly categorized into: Group EF (n=40)     had EF after oocyte retrieval and Control group (n=40) did not have EF. All women were     subjecte to the standard down-regulation regimen followed by controlled ovarian hyper     stimulation . Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was     collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained     for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating     factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining     amount was used for EF in EF group and was discarded in control group. Pregnancy was     diagnosed by measurement of β-HCG level and confirmed by transvaginal sonography as clinical     pregnancy   "
62446|NCT02468245|"     This study is being conducted by Bassett Healthcare Network in coordination with Bassett     Cancer Institute. Patients prescribed oral chemotherapies will be approached to consider     consent to this study. This study will try to establish if nursing interventions can help     improve patients' adherence to taking their oral chemotherapies as prescribed by their     doctor. Oral chemotherapies are emerging as a growing treatment of choice for many cancer     diagnoses. Adherence to the prescribed treatment plan is very important to gain the best     response to these types of treatments. The study will examine if nursing intervention via     weekly phone calls may help improve adherence to oral chemotherapy treatment plans.   "
62447|NCT02468232|"     The purpose of this study is to assess the effect of LCZ696 at a target dose of 200 mg b.i.d.     compared to enalapril 10 mg b.i.d., in addition to the background heart failure (HF)     treatment, on delaying time to first occurrence of either cardiovascular (CV) death or HF     hospitalization events in Japanese patients with stable chronic heart failure (CHF), New York     Heart Association (NYHA) classes II-IV and reduced ejection fraction (left ventricular     ejection fraction (LVEF) ≤ 35%).   "
62448|NCT02468219|"     This study will evaluate hemodynamic and functional changes resulting from valve intervention     in patients with severe aortic stenosis undergoing valve replacement (AVR) or transcatheter     aortic valve implantation (TAVI), and their influence on the pathophysiological mechanisms     involved in cardiovascular rehabilitation.   "
62449|NCT02468206|"     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection     versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric     variceal rebleeding and improvement in survival.   "
62459|NCT02468076|"     This phase-2 study aims to evaluate feasibility, safety and efficacy of thermal ablation of     biliary obstructive malignancies by means of radiofrequency ablation (RFA, ELRA, StarMed)     during endoscopic retrograde cholangio-pancreaticography (ERCP) with primary intent to obtain     palliative biliary drainage via stenting   "
62460|NCT02468063|"     The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and     full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of     randomization.- The study is an open level study. The investigators will strictly follow the     randomization table to give therapy as per the intervention arm.        -  Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and          terlipressin along with noradrenaline to maintain the MAP >65mm Hg.        -  Intervention arm             -  Arm (A) - Noradrenaline             -  Arm (B) - Noradrenaline + low dose terlipressin   "
62461|NCT02468050|"     The breast cancer screening and diagnostic period is associated with heightened symptoms of     anxiety and depression. Physical exercise has been found to effectively decrease these     symptoms in healthy and diseased populations. This study aims to determine if a pre treatment     exercise intervention can minimize symptoms of anxiety and depression in women undergoing     screening for breast cancer.   "
62462|NCT02468037|"     High tissue iron is a risk factor for diabetes even within the broad normal range of normal     human values. In order to demonstrate the benefits of reducing iron on glucose homeostasis     and to better define the parameters for larger clinical trials, the investigators will     subject individuals with prediabetes (impaired glucose tolerance, IGT) or early type 2     diabetes to phlebotomy in order to reduce serum ferritin concentrations and determine the     effect on glucose homeostasis as revealed by oral and frequently sampled intravenous glucose     tolerance testing.   "
62463|NCT02468024|"     To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC   "
62464|NCT02468011|"     Previous studies reported that myoelectrical activity increased during whole body vibration     (WBV). The investigators hypothesized that the change in soleus muscle length does not affect     the whole body vibration induced soleus reflex muscle activity but the change in ankle angle     affects the whole body induced soleus reflex muscle activity. The purpose of this study is to     test this hypothesis.   "
62465|NCT02467998|"     The goal of the Negative Pressure Wound Therapy Registry (NPWTR) for Wounds is to provide     real world patient data from electronic health records submitted to meet Stage 2 Meaningful     Use in order to understand the effectiveness and safety of various NPWT devices and methods     among patients with chronic wounds and ulcers. Randomized, controlled trials to establish     product efficacy routinely exclude patients with the co-morbid conditions common to patients     seen in usual clinical practice and thus the results of these Randomized Controlled Trials     (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among     typical patients. Patient registries are also ideal for assessing long term safety issues in     these devices.   "
62466|NCT02467985|"     Patients undergoing laparoscopic surgery suffer in 30-85% of cases of referred pain in the     shoulder in the first days following their intervention. Pain can be disabling and may even     delay the discharge of patients. Several techniques have been proposed to reduce this     problem. Promising strategies include the reduction of CO2 insufflation flow, lung     recruitment maneuvers and active aspiration of intraperitoneal air at the end of surgical     procedure to force gas discharge. The investigators wish to perform a randomized controlled     trial with 160 women, who will assess the effect of a combined approach, combining for the     first time lung recruitment maneuvers and aspiration of pneumoperitoneum in the Trendelenburg     position at the end of surgery and flow of insufflation reduces carbon dioxide (CO2) forming     the pneumoperitoneum during surgery, on the intensity of shoulder pain postoperatively. In     the control group the evacuation of the pneumoperitoneum will be done by opening the trocars     and external abdominal pressure at the end of surgery. No study to our knowledge has tested     the active aspiration maneuvers gas after laparoscopic surgery in gynecology. The study will     be preceded by a pilot study in 15 participants, who will be assigned to the control group to     determine the basic rate of referred pain in the shoulder in our people and improve test     management.   "
62467|NCT02467972|"     The addition of fructans or unripe banana flour to frozen meals can change the hormonal     parameters related to hunger and satiety, improve the bowel movements and increase in colonic     bacteria population measured by microbiological determinations (qPCR). The inulin no can     change bowel movements and increase in colonic bacteria population measured by     microbiological determinations (qPCR)   "
62468|NCT02467959|"     The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency     physician performed ultrasound in the diagnosis of acute appendicitis.   "
62469|NCT02467946|"     Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover,     Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these     reasons, questions arise whether ABVD could be still considered the standard treatment in HL     patients aged > than 60. Regimens containing other alkylators such as CHOP proved even     superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with     Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine)     proved very active in a pioneer study, reporting the preliminary results of a phase 1     multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For     all these reason the investigators decided to test the association of an alkylator with an     innovative mechanism of action and a very safe toxicity profile in the elderly such as     Bendamustine (Be) with BV in untreated elderly HL patients.      The combination of BV and Be, investigated in this study, might represent an innovative     treatment alternative for HL patients older than 60 years of age, especially for those of     them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable.     However, even when ABVD is given as upfront treatment for elderly HL patients, it is     associated with substantial dose reduction, treatment delay, toxicity, and treatment-related     mortality, with treatment outcomes remaining much inferior to those obtained in younger     patients. This drug association is expected to be safe, well-tolerated and to demonstrate     higher efficiency compared with ABVD. In this setting, it is expected that this therapy could     be offered to the large majority of elderly patients with a full treatment completion reached     in up to 80% of these patients.      Thus, the aim of this study will be to assess safety and efficacy of the above association.   "
62470|NCT02467933|"     Abusive prescribing exposes patients to unnecessary health risks and results in wasteful     public expenditures. This study will evaluate an innovative approach to fighting abusive     prescription: sending letters to suspected inappropriate prescribers warning them that they     are outliers compared to their peers and have been flagged for review. The study will target     high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the     investigators will assess the effect of the letters on prescribing of Seroquel, receipt of     Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes     of patients.   "
62472|NCT02467907|"     This study is to assess safety as defined by the frequency and severity of gastrointestinal     (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants     treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel     and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic cervical     cancer. In addition, this study will include evaluation of the overall safety profile of     bevacizumab in combination with paclitaxel and carboplatin in this setting, assessment of GI     perforation/fistula, GI-vaginal fistula and GU fistula events over time, and evaluation of     efficacy.   "
62473|NCT02467894|"     A two-group randomized clinical trial testing whether group-based care will help improve     blood pressure control in adult and adolescent patients with chronic kidney disease and     hypertension.   "
62474|NCT02467881|"     Diabetes Prevention Program translational efforts, such as the Group Lifestyle Balance     Program (GLB), have been shown to be effective in reducing weight and modifying diabetes and     CVD risk factors in a variety of diverse community settings. Although one of the two primary     goals of these DPP translation programs focuses on increasing physical activity levels, few     published DPP translation studies reported results on change in physical activity with only     one study reporting activity levels from an objective measurement instrument. In order to     completely understand the role that physical activity plays in making healthy lifestyle     change, it is critical that we validate the impact of activity using a valid and reliable     objective measure. In addition, current studies suggest that decreasing time spent sitting     may have a positive health impact separate from the effects of participating in planned bouts     of moderate intensity activity. Therefore, we propose to examine the impact of a modified     version of the GLB program, which will focus on decreasing sedentary/sitting behaviors. The     results of this project will provide information regarding best options for physical activity     within lifestyle intervention programs, focusing both on verifying the current role of     physical activity in lifestyle intervention using an objective measure and on examining an     alternative intervention option for translation efforts.   "
62475|NCT02467868|"     This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of     MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving     Neoadjuvant or Adjuvant Chemotherapy.   "
62476|NCT02467855|"     The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult     participants with essential hypertension.   "
62477|NCT02467842|"     All participants will receive a single dose of their assigned vaccine on Day 0. They will be     followed up for immunogenicity and safety through Day 21 post-vaccination. The serious     adverse events are collected for 6 months post-vaccination.   "
62478|NCT02467829|"     The aims of this study are to investigate what effect altering handle height of posterior     walkers has on forces through the walker, posture, efficiency, stability, speed, turning and     comfort, and to obtain data which helps therapists understand the bio-mechanics involved     during use and if this alters depending on age, posture or strength. All participants will     have cerebral palsy. This will allow informed prescription of walkers and identify potential     for redesign to improve efficiency, promote strengthening or improve posture to maximise     children's potential to continue functional walking into adulthood.   "
62479|NCT02467816|"     This study will evaluate an innovative school lunch intervention that is designed to increase     school meal participation and improve dietary intake among middle and high school students.   "
62480|NCT02467803|"     Fractures of the proximal humerus and the humeral head are most common injuries and the     management is challenging. Functional therapy with short immobilization, followed by an     accelerated physiotherapy protocol, is a simple, convenient, noninvasive, and efficient     management option. This prospective randomized study is aim to assess the function of the     upper extremity of patients who will be assigned to nonoperative treatment of a proximal     humeral fracture. The primary objective is the Constant score. Secondary objectives are the     Disabilities of the Arm, Shoulder, and Hand (DASH) instrument, measurement of shoulder range     of motion (ROM), pain and depression level with Beck Depression Scale.   "
62481|NCT02467790|"     To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or     normal renal function who were administrated subcutaneously single dose PEX168.To evaluate     dose adjustment of PEX168 administered in patients with renal insufficiency and provide a     scientific basis in patients with renal insufficiency of rational drug use.   "
62482|NCT02467777|"     Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.   "
62483|NCT02467764|"     The hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions     commonly make a significant improvement in the quality of life of patients. Infection can     occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of infected or not     infected character directly influences the surgical conduct. It is therefore recommended that     the positive or negative diagnosis is made in the most reliable way possible, but no single     element only allows a low diagnosis. The concomitant use of several clinical, radiological     and aggregated into a composite score history could help facilitate this preoperative     approach during reoperation on prosthetic joint   "
62484|NCT02467751|"     Metabolic profile in women of different body composition with polycystic ovary syndrome.   "
62485|NCT02467738|"     This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head     and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy,     also known as internal radiation therapy, uses radioactive material placed directly into or     near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry     radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs     131 into the wound bed after surgery may help treat microscopic cancer cells that may be in     the tissue after surgical removal of the tumor.   "
62486|NCT02467725|"     The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo     development and reproductive potential in comparison to static culture.   "
62517|NCT02467322|"     All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated     cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of     less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate     Volume Paracentesis) of less than 5 litres without albumin .   "
62487|NCT02467712|"     It is generally accepted that the fungal infection on a joint prosthesis is to be treated in     two surgical time: implant removal and prosthetic reconstruction. The service took the option     for over 10 years to treat bacterial infections in joint replacement by a change in time. In     four recent cases the diagnosis initially suspected of bacterial infection has been restated     on intraoperative bacteriological examinations fungal infection. It is therefore a     potentially harmful side effect of the chosen treatment option, but 4 patients in question     were all cured of their fungal infection after a postoperative antifungal therapy. The     objective of this study is to report these cases for discussion on the therapeutic choices in     fungal infections on joint replacement.   "
62488|NCT02467699|"     The knee prosthesis is a validated treatment for end-stage osteoarthritis, and this     intervention usually provides a significant improvement in the quality of life of patients.     However, a significant percentage of patients (up 30%) say disappointed with the outcome of     the intervention. One hypothesis that could explain these poor results might be poor     adaptation of the implants to the patient's anatomy, resulting in a non-physiological     kinematics for the patient. Multiple studies try to obtain an individual adaptation of the     intervention according to multiple criteria. The measurement of the kinematics of the knee     before surgery could participate in this process.   "
62489|NCT02467686|"     The purpose of this study is to evaluate the Cimicifuga racemosa effects on the sexuality of     women with Breast cancer using tamoxifen or aromatase inhibitor through questionnaires.   "
62490|NCT02467673|"     The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO)     transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein     (CRP), and cardiovascular risk factors in postmenopausal women.   "
62491|NCT02467660|"     1. Telephone Eligibility Screening        2. Baseline Visit, includes online questionnaires, physical measures, cognitive tasks,          voice recordings, physical recordings of brain waves, heart rate, breathing rate, and          sweat during computer tasks, collect saliva samples and respond to handheld device that          rings randomly for the two days following the visit        3. Randomized to receive (a) an internet-based Mindfulness Meditation program, (b) an          internet-based Health & Wellness Education program, or (c) no training. IF assigned to          receive a training program, participants complete weekly one-hour online trainings and          daily home practice for 6 weeks        4. Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline        5. All participants receive Meditation and Education programs after the Endpoint Visit        6. Online questionnaire follow-up 6 months after the Endpoint   "
62492|NCT02467647|"     To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on     the patients with multiple myeloma in maintain therapy.   "
62493|NCT02467634|"     A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with     bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.   "
62494|NCT02467621|"     Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however     the quantity and quality of evidence is low and potential harm has been reported.      The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton     pump inhibitor in adult critically ill patients in the ICU.   "
62495|NCT02467608|"     Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs     Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis   "
62496|NCT02467595|"     This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on     the anesthetic induction and emergence with fentanyl in children undergoing     adenotonsillectomy.   "
62497|NCT02467582|"     Following complete resection of their primary tumor, potentially eligible stage II or stage     III colon cancer patients will undergo central PIK3CA testing. Patients with somatic     mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a total of 3     years or until disease recurrence, patient death or withdrawal of consent, whichever occurs     first. Patients will be followed up for 10 years from the date of surgery.      The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact     on the indication to give (or not to give) adjuvant chemotherapy.   "
62498|NCT02467569|"     The purpose of this study is to assess the pharmacokinetics，safety and tolerability of     Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain     preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study     will be conducted in two parts. Part one, testing will be done on up to 16-31 subjects to     determine the safety and tolerability of Hemay 020 in patients with advanced solid tumors.     Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be added to the     trial to better define the tolerability and preliminary efficacy of Hemay020.   "
62499|NCT02467556|"     A ten week open label study intervention to evaluate the outcome for a psychological     intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS     patients.   "
62500|NCT02467543|"     Dysmenorrhea (painful menstruation) is a common gynaecological disorder that is prevalent in     more than 50% of women during their reproductive years. Primary dysmenorrhea describes cyclic     uterine pain without any identifiable or underlying causes. Menstrual pain results as a     consequence of endometrial ischemia, high levels of prostaglandins and other inflammatory     mediators. Conventional treatment for primary dysmenorrhea consists of non-steroidal     anti-inflammatory drugs and oral contraceptives, which may have adverse effects. Viburnum     opulus (Cramp bark) is a homoeopathic remedy well indicated for the treatment of     dysmenorrhea. While there are studies using Viburnum opulus in its herbal form, there is no     research assessing its efficacy in the homoeopathic form.      The aim of this study is to determine the efficacy of Viburnum opulus 3X in the treatment of     primary dysmenorrhea as measured with the modified Short Form McGill pain questionnaire     (SF-MPQ-2) and visual analogue scale (VAS) respectively.   "
62501|NCT02467530|"     This is an intervention study of the effects of food preparation on the gut bacteria in     patients with end stage renal disease on peritoneal dialysis. This is a dietary intervention     consistent of consuming low amounts of advanced glycation end products (AGEs), the products     of protein and sugar interaction during food processing and preparation using high direct     heat.   "
62518|NCT02467309|"     The purpose of this study is to determine whether deficiency of Vitamin D has association     with outcomes of children with bacterial meningitis.   "
62502|NCT02467517|"     The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to     that of a placebo in patients with refractory neuropathic pain.      The secondary outcomes are:        1. - To compare the additive analgesic efficacy of prior administration of magnesium          sulfate to that of placebo and ketamine only, on the effectiveness of intravenous          ketamine treatment,        2. - To study the evolution time of pain and analgesia after the intravenous administration          of ketamine and placebo,        3. - To study the correlation of the analgesic response to administered products          respectively ketamine, ketamine and magnesium sulfate, placebo.   "
62503|NCT02467504|"     Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by     symmetric poly-arthritis usually involving the small joints of the hands and feet. In     addition, various extra-joint manifestations may develop. Several immunomodulating agents     have been attempted in the treatment of RA without achieving satisfactory results.     Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,     which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose     IL-2 could be a novel therapy in active RA patients. This clinical study will test the     efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a     single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the     effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2     (N = 30) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 30)).   "
62504|NCT02467491|"     The purpose of this study is to explore the feasibility and acceptability of a new physical     activity technology (Jintronix) based on TV screen, virtual games and motion sensing cameras     among pre-disabled older adults.   "
62505|NCT02467478|"     Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels     which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the     blood. Research has shown that improving the survival of these special blood cells may     decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart     disease. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine     used along with insulin or with oral medications to lower blood sugar in people with Type 2     diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4)     inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2     diabetes.      Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor     stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The     investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce     cardiovascular risk by improving EPC survival and function above and beyond adequate glucose     metabolism control   "
62506|NCT02467465|"     The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel.     About 10% to 20% of the population suffer once during their lifetime. PF concept began to     describe at the end of XX century through the discovery of new clinical and histopathological     signs of the plantar fascia. The difficulty of diagnosis, understanding and treatment of PF     require us to develop new treatment avenues to improve the approach and the understanding of     it. Dry needling (DN) as a treatment of myofascial pain syndrome (MPS) and myofascial trigger     points (MTP) of muscle associated with the pathology, it may be a good treatment strategy, as     demonstrated in the treatment of MPS in other body regions such as the neck, shoulder or the     lumbar spine.   "
62507|NCT02467452|"     The purpose of the study is to demonstrate the triple combination of beclometasone     dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality     of life in COPD patients (Chronic Obstructive Pulmonary Disease).   "
62508|NCT02467439|"     The primary purpose of this research is to assess the benefit of an unaware intervention     package for identifying high risk persons who are unaware of their HIV infection status.     This intervention package includes screening for acute HIV infection, contract sexual partner     referral, and peer referral.   "
62509|NCT02467426|"     This is an observational study of isolated thoracic perfusion with subsequent hemofiltration     to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in     malignant pleural mesothelioma.   "
62510|NCT02467413|"     The primary objective of this study is to evaluate the efficacy of BAC patients with     Alzheimer's disease or vascular dementia.The secondary objective of this study is to evaluate     the safety of BAC patients with Alzheimer's disease or vascular dementia.   "
62511|NCT02467400|"     This study is designed to answer the question as to whether the sympathetic nervous system is     an important determinant of bone metabolism in humans.   "
62512|NCT02467387|"     A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of     ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic     heart failure.   "
62513|NCT02467374|"     The purpose of this study is to find out more about how the brain stores emotional learning     in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human     beings learn not to fear. We are also interested in learning about how behavioral therapy     (BT) for OCD affects emotional learning in the brain. We hope this study will help us     understand why people with OCD cannot control unwanted fear and to develop better treatments     for adults with OCD. Patients will be randomly assigned (like the flip of a coin) to receive     12 weeks of BT or 12 weeks of waitlist, followed by 12 weeks of BT. We are seeking     individuals 18-60 with OCD and individuals with no psychiatric history. Participation     includes a diagnostic evaluation, 12 weeks of BT or 12 weeks of waitlist followed by BT,     questionnaires, and up to six (6) MRI scans. You may receive up to $500 for your     participation and reimbursement for parking.   "
62514|NCT02467361|"     This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination     with immunotherapy in adult patients with advanced cancers. The goal of the study is to     determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents.   "
62515|NCT02467348|"     All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on     chronic Liver Failure). ACLF will be randomize into      Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8     gms/L of ascitic fluid      Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin   "
63701|NCT02451826|"     The purpose of this study is to determine the effect of a contraceptive vaginal ring on     inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women.   "
62519|NCT02467296|"     Currently, the recommendations for sodium intake restriction for patients with heart failure     are mostly based on expert consensus and observational evidence, whereas smaller randomized     studies have actually suggested that strict dietary sodium reduction may be harmful in heart     failure. In the present clinical trial pilot study, the investigators plan to collect data on     enrollment rates, compliance, outcomes, and safety of a 12-week dietary intervention in heart     failure patients, with prepared food containing two different levels of sodium (1,500 mg and     3,000 mg) daily, followed by a 12-week surveillance for safety and effectiveness. The goal is     to inform the design of a fullscale clinical trial that will provide more definitive evidence     for dietary sodium recommendations in heart failure.   "
62520|NCT02467283|"     Current concepts of the causes of periodontitis implicate a bacterial infection as the     primary cause of the disease. Several bacterial species residing in a biofilm on tooth     surfaces are closely associated with periodontitis. Chronic periodontitis (CP) is initiated     and sustained by bacterial plaque, but host defense mechanisms play an integral role in its     pathogenesis.      Gene expression profiling is a powerful means of generating comprehensive genome-level data     sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides     significant insight information for these diseases. Gene expression profiling may provide an     evidence for involving genes in the pathogenesis of CP and generate further information other     than clinical signs and symptoms of CP.      The aim of this study was to identify gene-expression patterns of patients with chronic     periodontitis by whole-transcriptome gene-expression analyses.   "
62521|NCT02467270|"     The purpose of this study is to compare and characterize the efficacy and safety of ponatinib     in patients with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in a range of     doses.   "
62522|NCT02467257|"     The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin     inducing agent for sickle cell anemia patients.   "
62523|NCT02467244|"     The aim of this study is to evaluate plasma adiponectin level, insulin resistance,     cardiovascular risk and their correlation (if any) in patients with hypothyroidism and also     to investigate the effect of levothyroxine on these parameters. The study may explore the     lacunae in present treatment protocol and can suggest the possibilities of add-on therapies     for a better management.   "
62524|NCT02467231|"     Women of reproductive age who will receive treatment for cancer that includes chemotherapy     may participate in a study measuring ovarian function over time. Eligible women are asked to     complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and     a blood test before, during and after cancer treatment.   "
62525|NCT02467218|"     Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians.     Although the etiology and pathophysiology are poorly understood, there is a well-recognized     association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia,     abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM.     Pharmacological and non-pharmacological strategies are directed to control symptoms such as     pain, fatigue, non-restorative sleep and depression.      Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric     chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of HBOT is     based on a dramatic increase in the amount of dissolved oxygen carried by the blood which     enables oxygenation of ischemic areas with compromised circulation. It also activates     oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory     response, induces brain neuroplasticity and possesses analgesic effect.      While some interventions offer benefit for some patients, additional treatment alternatives     are needed for patients with FM in whom currently available options are either ineffective or     poorly tolerated. Given its physiological effect, HBOT could be considered as a potential     therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system     and controlling FM symptoms. The results from this study could therefore provide new     information supporting the basic science underling the pathophysiology of this disease and     stimulate novel therapies for patients suffering with FM.   "
62526|NCT02467205|"     The overall aim of this randomized control trial study is to investigate the effectiveness of     a six-month, community based, pedometer supported, walking programme, along with an education     programme incorporating behavioural change techniques on steps count and sedentary time,     disease activity, functional capacity and cardiovascular risk of people within the first five     years of being diagnosed with RA.   "
62527|NCT02467192|"     Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and     specificity of clinical signs as well as images from chest radiography (RT). New diagnostic     tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a weak     dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide additional     accuracy in the etiological clarification of pneumonia in elderly people.      As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3 months     of follow-up) prospective study including the Divisions of Internal Medicine, Rehabilitation,     Geriatrics and Radiology of the University Hospitals of Geneva. In this study, patients >65     years old with a clinical suspicion of low respiratory tract infection (LRTI) will be     included. They will be prescribed antimicrobial therapy. Both chest radiography and low-dose     thoracic CT will be performed within the first 72 hours after admission, as will blood tests     and a nasopharyngeal swab.      The clinician's diagnosis, both before and after the results of the CT, will be compared at     the end of the study to the adjudication committee's diagnostic opinion which will have     access to all available clinical, laboratory and chest X-ray data and which will be     considered the gold standard. At the end of the study, all the CT images will be     blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of     pneumonia will be assessed, both for its sensitivity and specificity in this population.      During the first 12 months of the study, all patients will undergo a systematic     nasopharyngeal swab at admission and at discharge, from which eluates will be conserved.     During the next 12 months, virological and bacteriological polymerase chain reactions (PCR)     will be performed, using new diagnostic tools, in order to determine the etiological     diagnosis in this population and to evaluate the impact of the new tools in the management of     pneumonia for this population.      Analysis of these data will allow clinical, radiological and microbiological correlation.   "
62528|NCT02467179|"     The purpose of this study is to compare standard manual and robotically controlled catheter     ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of     the CTI is standard treatment for patients with a history of atrial flutter, and those     undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation     are used in standard clinical practice at The University of California, San Diego (UCSD) for     ablation.   "
62647|NCT02465632|"     This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,     designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5%     topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel,     Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne     vulgaris.   "
62529|NCT02467166|"     The purpose of this study is to determine if the use of Circa™ temperature monitoring system     during ablation procedures will reduce the risk of esophageal lesions or damage. Esophageal     lesions caused by ablation could later develop into a potentially fatal atrio-esophageal     fistula, which is hole between the upper chamber of the heart and the esophagus. Although     development of atrio-esophageal fistula following atrial fibrillation ablation is extremely     rare, the complication is severe and potentially life-threatening. Therefore, monitoring of     esophageal temperatures has been adopted to prevent the development of esophageal lesions.     The Circa™ temperature monitoring system allows cardiac electrophysiologists to monitor and     thereby limit temperatures as well as duration of ablation in the esophagus throughout the     procedure.   "
62530|NCT02467153|"     This study aims to determine whether vitamin D3 supplementation is any more effective in     improving musculoskeletal function when combined with exercise training compared with     exercise training alone.   "
62531|NCT02467140|"     A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia     repair comparing the ProGripTM self- fixating mesh with tack fixation.   "
62532|NCT02467127|"     To date there are conflicting data concerning a correlation between plasma vitamin D levels     and headache.      The aim of this study was to evaluate plasma vitamin D levels in patients with headache     admitted to the Center of Headache of Pugliese Ciaccio Hospital.   "
62533|NCT02467114|"     Attention can be defined as the preparedness to rapidly and accurately respond to stimuli     coming from the investigators environment and to effectively select between relevant and     irrelevant information. According to a current model, visual attentional control is based on     two separate groups of brain regions, so called brain networks. These networks control     different attentional aspects (e.g., spatial/non-spatial attention) and they interact with     each other. A disruption of these interactions can lead to attentional disorders such as     hemispatial neglect. Patients with hemispatial neglect have difficulties directing their     attention to the left visual field and they act as though the latter does not exist.      To date, the interactions between the two attentional networks are poorly understood. The aim     of this study consists in further clarifying different aspects of these interactions and     their influence on visual perception in healthy participants and in patients with hemispatial     neglect. Transcranial magnetic stimulation (TMS) will be the principal method applied in this     study. TMS is a painless and non-invasive method, with which the activity of brain areas can     be influenced temporarily. This allows us to draw conclusions regarding the functions and     interactions of these brain areas.      This study is designed to have a significant impact on the basic understanding of attentional     control in the human brain and it can benefit the comprehension and treatment of attentional     disorders, such as hemispatial neglect.   "
62534|NCT02467101|"     The purpose of this study is to determine the efficacy of treatment with intralesional     injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with     placebo), between three months, six months and baseline.   "
62535|NCT02467088|"     Premenstrual Syndrome (PMS) is a group of physical, mental and behavioural symptoms that     occur cyclically through the luteal phase of the menstrual cycle and resolve within three     days of the onset of menstruation. Many women are affected by the physical and psychological     symptoms of PMS. The symptoms of PMS can change behaviour and wellbeing of women which has an     impact on families, social life and work. Research has shown that women with PMS reported     additional days missed at work compared to women that do not suffer with PMS. A study done by     Brohi et al. (2011) showed that PMS is a common problem that occurs in 81.25% of women and     has an adverse impact on a woman's quality of life. Conventional treatment is limited, not     always effective and is associated with many side effects. Research using individualised     homeopathic treatment, known as the homeopathic similimum, in PMS has shown to be well     tolerated as well as have a positive impact on the symptoms of PMS although further research     is warranted in this regard. There have not been any studies done on homeopathic treatment in     Indian females in South Africa.      The aim of this study is to determine the effect of individualised homeopathic treatment on     females of Indian origin who are suffering with symptoms of PMS, using observational studies.   "
62536|NCT02467075|"     This double-blinded placebo-controlled study will examine the incidence and significance of     contrast-induced acute kidney injury following IV iodine-based contrast material     administration in subjects with stage IIIB or stage IV chronic kidney disease.      Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to     evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive     either weight-based low-osmolality iodinated contrast material or saline. The primary outcome     measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.   "
62537|NCT02467062|"     The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and     evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic     valve diseases.   "
62538|NCT02467049|"     In the prevention of thrombosis related to catheter placement it is important to have a right     position of the catheter tip. Therefor we want to assess which technique is the most     successful in the placing of a PICC.   "
62539|NCT02467036|"     The purpose of this study is to evaluate whether a behavioral weight loss group in     conjunction with a prescribed breakfast can help children between 8 and 12 years of age     change their behaviors to help them lose weight and become healthier.   "
62553|NCT02466854|"     The BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with     diagnosis of Acute Coronary Syndrome) registry is an international observational database of     bleeding outcomes for patients who are discharged with diagnosis of ACS and underwent     Percutaneous Coronary Intervention (PCI), including myocardial infarction or unstable angina.      BleeMACS registry enrolls a total of more than 15,000 patients, including data from 16     hospitals in 11 countries: North America (Canada), South America (Brazil) Europe (Germany,     Netherlands, Poland, Spain, Italy, Macedonia, Greece), and Asia (Japan and China).      The end-point of this study is to characterize patients at high risk of bleeding and to     develop a risk score to accurately predict the risk of major bleeding within the first year     after discharge from the hospital for an ACS.   "
64489|NCT02441543|"     Preclinical studies and clinical observations have shown the Phosphoinositide 3-kinase (PI3K)     /Protein kinase B (AKT) /mammalian (mechanistic) target of Rapamycin (known as the     'mTOR-pathway') signaling to be deregulated in several tumors.   "
62540|NCT02467023|"     The purpose of this research study is to see if electrical stimulation of the leg muscles     will improve strength in patients receiving mechanical ventilation in the intensive care unit     (ICU). ICU care frequently results in chronically critically ill (CCI) patients. Some CCI     patients develop persistent inflammation/immunosuppression and catabolism syndrome (PICS),     and they have morbid long-term outcomes. CCI patients with PICS often develop severe limb     muscle atrophy, weakness and accelerated protein catabolism. Limb muscle dysfunction in PICS     is due to many factors including sepsis/inflammation, proteolysis, apoptosis, and inactivity.     Despite the seriousness of limb muscle weakness in CCI patients receiving mechanical     ventilation, little is known about exercise strategies to treat this problem. There is     limited knowledge about how strength training impacts inflammation and catabolism in CCI     patients. In addition, an assessment of the effect of exercise on markers of inflammation and     protein catabolism on muscle samples obtained with biopsy techniques and venous blood samples     will be performed. This project will further understanding of how treating CCI-related muscle     weakness with strength training cannot only improve muscle function, but also potentially     blunt the inflammation and catabolism of PICS.   "
62541|NCT02467010|"     Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated     high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide,     also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory     rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a     myeloma functionality.      The objectives of the present study are whether patients with refractory or relapsed multiple     myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit     from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects.     Recently two studies have shown with thalidomide that maintenance therapy might improve EFS     and one study also the OS.   "
62542|NCT02466997|"     Multicentric French parallel double-blind randomized versus placebo study   "
62543|NCT02466984|"     Subcutaneous (SC) route has become a standard of care of many drugs administration in     palliative medicine. A preliminary study showed that, although it was widely adopted among     palliative care practitioners for routinely prescribed medications, standards of proof are     still lacking for many molecules. Among them, metoclopramide is a largely employed drug for     nausea and vomiting treatment, particularly in palliative care and oncology. Therefore, the     investigator aim to study absorption and efficacy of subcutaneous administration of     metoclopramide.   "
62544|NCT02466971|"     This randomized phase II trial studies radiation therapy and cisplatin with triapine to see     how well they work compared to the standard radiation therapy and cisplatin alone in treating     patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA     vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink     tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. It is not yet known whether radiation therapy and     cisplatin are more effective with triapine in treating cervical or vaginal cancer.   "
62545|NCT02466958|"     The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to     placebo for the treatment of depression in older adults.   "
62546|NCT02466945|"     The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in     patients with dentinal hypersensitivity.   "
62547|NCT02466932|"     This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters     in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were     measured by GD-SA and relationships between all anterior segment parameters obtained by this     device and birth weight were analyzed.   "
62548|NCT02466919|"     The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel     10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential     therapy.   "
62549|NCT02466906|"     This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy     for patients with resectable stage III colon cancers.   "
62550|NCT02466893|"     Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe     and effective for treatment of AIS within 3 hours of symptom onset, and newer evidence has     shown potential benefit out to 4.5 hours. Mechanical thrombectomy for AIS patients has been     shown in clinical trials to be safe up to 8 hours after symptom onset. Recent trials     utilizing advanced imaging to identify patients with large vessel occlusions amenable to     intra-arterial thrombectomy (IAT) have shown superiority endovascular therapy over medical     therapy to result in improved patient functional outcomes. Pilot data utilizing the ADAPT     approach has shown superior technical results with similar functional outcomes while lowering     procedure time and device costs versus traditional stent retriever as a first line therapy     approaches   "
62551|NCT02466880|"     This study aims to evaluate a culturally appropriate, low cost and sustainable management     plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials     confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote     improvements in diet, increased physical activity and weight loss. Translation of lifestyle     intervention to real-life settings however remains a major challenge.      The investigators therefore propose a diabetes management trial for T2DM patients using     telemedicine. This project's innovations include the use of information technology to deliver     messages to the physicians while similarly involving family members of diabetics to manage     the patient's condition collectively. This creates a sense of well-being, empowering the     individual as well as the community to be responsible for their own health and well-being   "
62552|NCT02466867|"     This is an open label, multi-center, multi-application pharmacokinetic study in pediatric     subjects with tinea corporis.   "
62589|NCT02466386|"     To evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15,     20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity     Disorder (ADHD). Subjects will be enrolled into this study from antecedent study SPD489-211     (NCT02402166) or SPD489-347.   "
93343|NCT02064283|"     This study will evaluate the feasibility of identifying changes in diffusion MRI     characteristics of bone that correlates with response to therapy in men with metastatic     prostate cancer.   "
62554|NCT02466841|"     Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most     common compressive neuropathy of the upper extremity (carpal tunnel is the most common).     Patients who fail conservative treatment (activity modification, splinting, medications) are     offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve     at the elbow, but the ideal release has not been determined. These techniques vary from     simple decompression of the nerve (in-situ release, endoscopic release), to decompressing the     nerve and moving it anteriorly to take tension off the nerve (subcutaneous transposition,     sub-fascial transposition, sub muscular transposition), and removing part of the medial     epicondyle (medial epicondylectomy). Each procedure has purported benefits and also potential     complications. Simple in-situ release has the benefit of shorter operative times and less     surgical dissection, however, the nerve may subluxate post-operatively and cause persistent     pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial transposition,     sub muscular transposition) prevent subluxation and take tension off the nerve, however, they     require more dissection, larger incisions, and also partially devascularize the nerve. Medial     epicondylectomy prevents subluxation and decompresses the nerve, but some patients may have a     prolonged recovery and persistent pain from removing part of the bone.      The purpose of this study is to prospective evaluate patients undergoing cubital tunnel     release according to the standard practice and preference of their surgeon. The investigators     plan to compare the different techniques at standard post-operative intervals.   "
62555|NCT02466828|"     Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults.     Despite recent diagnostic and therapeutic advances, including aggressive surgical resection     and chemoradiation, the prognosis of GBM has improved only slightly over the past two     decades, with median survival of approximately 15 months. Tumor hypoxia is a feature of GBM     that contributes to poor outcome through multiple mechanisms such as 1) overexpression of     enzymes that play roles in temozolomide resistance, the main chemotherapeutic agent in GBM     and 2) increase expression of cancer stem cells which are more resistant to radiation.     Hypoxic tumour regions are associated with higher rates of progression and recurrence.      In this study the investigators will use an advanced MRI technique called qBOLD to     non-invasively measure oxygenation in GBM and obtain targeted biopsies. The investigators     take advantage of physical characteristics of Ferumoxytol (Feraheme®) which is an iron     supplement, and utilize two recent technical advances not previously used in human tumours to     quantitatively measure oxygenation in GBM.      Prior knowledge of hypoxia can assist in prognostication and individualization of treatment     planning with special focus on hypoxic regions by targeted radiation dose or regimen     modulation; consideration of more intensive chemotherapy regimens; more aggressive and     targeted surgical resection and closer short-term clinical and imaging follow-ups.   "
62556|NCT02466815|"     The purpose of this study is to assess the relative bioavailability of 2 prototype G-025     tablets compared with the current G-018 tablet.   "
62557|NCT02466802|"     This is a phase 1 study of sildenafil in combination with regorafenib in patients with     progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted     for the dose escalation of the treatment combination: additional patients will be enrolled at     the MTD until a total of 12 patients have been treated at the MTD.   "
62558|NCT02466789|"     The purpose of this study is to improve the investigators ability to diagnose von Willebrand     Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening     blood test used to determine if a person has VWD. This new screening blood test can determine     a diagnosis more rapidly than current blood tests. Also this test could be available at local     hospital labs rather than require samples to be sent to bigger more specialized labs.   "
62559|NCT02466776|"     The purpose of this study is to determine the optimal skin closure technique (staples versus     subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass     index (BMI) of >/= 40kg/m2.   "
62560|NCT02466763|"     In 1985, the United States Food and Drug Administration (FDA) approved multichannel cochlear     implants (CIs) for adults with profound hearing loss; and in 1990, implantation was approved     for children. Since then, this procedure has become the standard of care for patients with     severe-to-profound sensorineural hearing loss. Successful outcomes are dependent not only on     extrinsic factors, but also on intrinsic factors that cannot always be modified by the CI     team. Significant predictive factors for hearing outcomes in patients with CIs have been     previously reported. These include, but are not limited to, duration of deafness, level of     preimplant speech recognition, pre/postlingual status, and the coupling of device electrodes.     Recipient age does not appear to have a significant impact on hearing outcomes in elderly     candidates.      Earlier studies have found that, because of its dimensions and proximity to the spiral     ganglion cells, the scala tympani (ST) is the preferred location for CI electrode placement.     A number of recent studies have proposed that intraoperative factors may be important     determinants of electrode location and possibly of audiological outcome. Preliminary reports     suggest that intracochlear electrode position- specifically, placement within the ST-is     associated with improved audiological outcomes. Additionally, different surgical techniques     have been proposed to minimize trauma during electrode insertion and to increase the     likelihood of placement within the ST - namely round window and anteroinferior cochleostomy     electrode insertion.      Currently, the best surgical approach for electrode insertion is highly debated, fueled by a     lack of strong evidence to support one method over another. While a number of CI centers have     begun to utilize a round window approach, many large volume centers in the United States and     world wide continue to routinely employ cochleostomy electrode insertions. With an increasing     number of patients being implanted with greater degrees of residual hearing, such data will     become critical towards reducing intracochlear injury and optimizing patient outcomes. To the     investigators' knowledge, no clinical study has prospectively investigated the relationship     between surgical insertion technique, intracochlear electrode location, and postoperative     hearing outcomes. To this end, the investigators are initiating a multicenter prospective     randomized controlled double-blinded study comparing round window and cochleostomy cochlear     implant electrode insertion.   "
62561|NCT02466750|"     This study is being conducted to collect safety and immunogenicity data for the WEE vaccine,     TSI-GSD 210. Enrollment in this protocol is offered for personnel who enter areas where this     virus is used in research or is endemic (an area where this disease process is found to occur     frequently).   "
62562|NCT02466737|"     Although there is no doubt that the presence of lymph node metastases worsens prognosis of a     patient, unambiguous evidence to support lymph node dissection is still lacking. For many     solid tumors, the role of lymph node dissection is yet controversial, and may depend on the     tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast     cancer is now considered as staging procedure that does not seem to influence breast cancer     mortality. Women with breast cancer have benefitted greatly from a series of carefully     performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA     is to show that less axillary surgery is better, in that oncological outcomes are the same     and less surgical intervention will result in fewer surgical complications.   "
62563|NCT02466724|"     Colorectal cancer (CRC) is a common and life threatening condition that will affect one in     thirteen individuals. Colonoscopy is the most commonly used procedure to identify colorectal     malignancies or precancerous lesions at an earlier stage, which affords an opportunity for     cure. However, low level of bowel cleanliness hinders polyp detection and therefore can limit     colonoscopy effectiveness. Historically, the majority of the studies have focused on     pharmacological factors to optimize bowel preparation quality. Recently, non-pharmacological     factors have been found to have significant increases in bowel preparation quality. The     purpose of this study is to evaluate the effectiveness of web-based instructions vs. the     historical phone/letter instructions given to patients planning to have a colonoscopy.   "
62564|NCT02466711|"     The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric     volume, motor and sensory effects in healthy patients.   "
62565|NCT02466698|"     Clostridium Difficile infections (CDIs) are treated initially with antibiotic therapy and     supportive care, with surgical intervention reserved for patients with significant systemic     toxicity or perforation. Severe CDI may be refractory to medical management and require     surgical intervention, carrying a mortality of approximately 40%.      Mortality associated with CDI increases significantly as the severity of the infection     increases. In patients failing medical management, earlier operation is associated with     decreased mortality. However, the lack of validated tools to predict the necessity for     surgical intervention, combined with the significant morbidity associated with total     colectomy significantly reduces the likelihood of patients receiving early surgical     intervention. The purpose of the proposed study is to assess the addition of intestinal PEG     lavage via nasojejunal tube to usual care in the treatment of adult patients with severe CDI     who have no immediate indication for surgical intervention.   "
62566|NCT02466685|"     The goals of this study are to evaluate the efficacy of JNJ-18038683 in an 8 week trial to     ameliorate the cognitive deficit and reduce residual depressive symptoms in 60 stable bipolar     outpatients receiving treatment for depression. JNJ-18038683 will be studied and compared     with placebo as adjunctive treatment to standard pharmacologic treatment for bipolar     disorder.   "
62567|NCT02466672|"     This study will measure the effect of anemia on the outcomes of hospitalized children with     severe pneumonia.   "
62568|NCT02466659|"     To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among     patients aged 3 to < 11 years old.   "
62569|NCT02466646|"     The purpose of this study is to determine whether full-mouth disinfection is effective in the     initial periodontal treatment of generalized aggressive periodontitis on clinical parameters     and gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) levels     compared with conventional initial periodontal treatment and full-mouth initial periodontal     treatment.      The investigators' hypothesis is to test whether full-mouth disinfection in the initial     periodontal treatment of generalized aggressive periodontitis enhance the clinical and     biochemical parameters in comparison to conventional initial periodontal treatment and     full-mouth initial periodontal treatment.   "
62570|NCT02466633|"     To increase the potential for timely detection and treatment of cardiac events, hospitals     have implemented a number of different cardio-respiratory monitoring methods for at-risk     patients. The goal of this study is to compare different monitoring methods to determine the     most efficient method to monitor hospitalized patients - the method that will lead to the     quickest response to critical heart rhythms. The investigators will then test the efficiency     of this monitoring method by implementing it in a new patient care unit.   "
62571|NCT02466620|"     The purpose of this study is to study the validity, reliability and practicality of the     different weight estimation methods (parent estimation method, Mercy method, Broselow tape,     original and update APLS) in Thai children.   "
62572|NCT02466607|"     The electroretinogram (ERG) is a diagnostic test that measures the electrical activity     generated by cells in the retina in response to a light stimulus. Typically, an ERG is     recorded with white flash when the pupil is dilated. RETeval Visual Diagnostic Device     (RETeval) generates an array of color flashes, which allows studying whether color flash     would be a useful diagnostic tool.      Full pupil dilation is required to obtain a response from the whole retina. However, this     requirement often limits a patient's flow in the clinic and increases the overall time     patients spend at the eye practitioner. RETeval provides the possibility of recording ERGs in     un-dilated pupils therefore making the whole exam easier and shorter. These results need to     be compared to the classic, fully dilated ERG and evaluated for efficiency.      The purpose of this research study is to use the RETeval device to measure the eye's     electrical response and how it changes with different stimuli such as changing flash color or     pupil dilation.   "
62573|NCT02466594|"     This study evaluates the impact of active thermoregulation on free flap microcirculation     following free flap transfer. Thermoregulation is performed by passive warming, active     warming (water circulation based device) and active cooling. Changes in microcirculation are     assessed using combined laser Doppler flowmetry and remission spectroscopy.   "
62574|NCT02466581|"     This is an international (Nordic) trial designed to compare the safety and efficacy of active     conventional therapy (ACT) and three biologic treatments (Certolizumab-pegol, Abatacept or     Tocilizumab) in subjects with early rheumatoid arthritis (RA). The global aim of this study     is to assess and compare two alternative de-escalation strategies in patients who achieved     low disease activity during first-line therapy in the NORD-STAR study.   "
62575|NCT02466568|"     The purpose of this study is to find out what effects (good and bad) a tumor vaccine     (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer.     Another purpose of the study is to find out the maximum tolerated dose of nivolumab in     combination with GM.CD40L vaccine. Investigators also want to find out if the combination of     GM.CD40L and nivolumab can boost the immune system of participants like you, and how their     immune system reacts, both before and after the treatment.   "
62590|NCT02466373|"     This study is developed for assessing the pharmacodynamic and pharmacokinetic properties of     intravenous (IV) clonidine in critically ill patients on the ICU, and to estimate the optimal     dosing strategy for IV clonidine.   "
64500|NCT02441400|"     To provide a research tool enabling physicians to monitor long term clinical outcomes for     patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES     Stimulation System.   "
62576|NCT02466555|"     The purpose of this study is to investigate the effects of the BEATS Music Therapy Program on     the self-efficacy, trust, knowledge, and adherence of young adult patients with sickle cell     disease during transition.      Primary Hypotheses:      Compared to baseline, young adult patients with sickle cell disease who receive the music     therapy interventions will report:        1. Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale          (SCSES),        2. Higher trust in health care providers as measured by the Wake Forest Trust in the          Medical Profession Scale, and        3. Higher sickle cell disease knowledge as measured by the Seidman Sickle Cell Knowledge          Quiz.      Secondary Hypotheses      1. Compared to the one year prior to the study period, young adults with sickle cell disease     who receive the music therapy interventions will have a higher rate of adherence to clinic     appointments during the one-year study period.      Additional Questions        1. Do music therapy interventions influence attendance to scheduled blood transfusions?        2. Do music therapy interventions influence the rate of hospital utilization as measured by          Emergency Department visits, Acute Care Clinic visits, and admissions during the study          period compared to the previous year?        3. Do music therapy interventions influence adherence to hydroxyurea therapy for patients          receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the          study period?        4. Do music therapy interventions influence adherence to iron chelation therapy for          patients receiving iron chelation therapy as measured by ferritin count during the study          period?   "
62577|NCT02466542|"     This study aims to compare the quality of perioperative analgesia of esmolol in patients     undergoing mastectomy.   "
62578|NCT02466529|"     Spinal muscular atrophy (SMA) is an autosomal recessive disorder characterized by     degeneration of motor neurons in the spinal cord and caused by mutations of the survival     motor neuron 1 (SMN1) gene.      The investigators will conduct a systematic review of the contents and activities collected     via a comprehensive case report form. Patients who fulfilled diagnostic criteria for SMA type     1 will be reviewed retrospectively.   "
62579|NCT02466516|"     This study will evaluate the safety and tolerability of GS-4997 alone or in combination with     Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages     F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.   "
62580|NCT02466503|"     The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide     HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.   "
62581|NCT02466490|"     Fimasartan (FMS) is an AT1 receptor antagonist indicated for once a day administration,     currently approved for the treatment of essential hypertension in Corea and Mexico. As the     safety and efficacy of FMS was initially demonstrated in Korea only, it was necessary to     address the potential for ethnic factors to have an effect on the drug´s efficacy and safety     in the Mexican population. To address this need, a cohort of 272 Mexican subjects with grades     1-2 essential hypertension were sequentially treated on a treat to target basis (target:     sitting Diastolic Blood Pressure (sDBP) <90 mmHg) with 60 mg FMS once a day (8 weeks), either     120 mg FMS or 60 mg FMS+12.5 mg HCTZ once a day (randomized 4 week treatment period) and 120     mg FMS once a day (during 12 weeks) for a total treatment period of 24 weeks.   "
62582|NCT02466477|"     Evidence exists supporting the ability of genetic variations to influence patient drug     response and side effects. Previous studies utilizing an open-label design have shown     significant improvement in major depressive disorder (MDD) patient outcomes following use of     the GeneSight Psychotropic (GEN) test. The first objective of this trial is to utilize a     double-blinded, randomized clinical trial design to replicate previous findings of     improvement in clinical outcomes in MDD subjects whose medication therapy was guided by GEN     testing. Another objective is to determine the added benefit of Enhanced-GeneSight (E-GEN)     compared to GEN for the pharmacogenomic guidance of treatment selections. Furthermore, this     trial intends to develop an evidence-based case for the value of GEN and E-GEN to Canadian     healthcare payers.   "
62583|NCT02466464|"     The purpose of this study is to compare a new treatment for nosebleeds to the treatment that     has been used for many years.   "
62584|NCT02466451|"     Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or     oesophageal atresia : assessment of lung function parameters; assessment of quality of life     and cognitive development; assessment of stress parenting and strategies of adaptation.   "
62585|NCT02466438|"     Severe infection is one of the main causes of disease in hospitalized children and can be     deadly. With the lack of novel antibiotics approved in children and the emergence of drug     resistant bacteria, there is a critical need to optimize dosing of existing antibiotics.     Piperacillin-tazobactam is an antibiotic frequently used for treatment of severe infection in     children in Canadian hospitals. To optimize this antibiotic's efficacy despite the rise of     antibiotic resistance, alternative dosing strategy is commonly used in adults, which consists     of prolonging the time during which the drug is infused (4 hours instead of 30 min). Children     clear piperacillin-tazobactam from their bodies at a slower rate than adults, consequently     extended-infusion strategy cannot be directly extrapolated from adult to children. We believe     that younger children need piperacillin-tazobactam infusions that are shorter compared to     adults to achieve appropriate concentrations.   "
62586|NCT02466425|"     The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD     in children and adolescents (aged 6-17 years). The primary objective of this study is to     evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in     the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.   "
62587|NCT02466412|"     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile     of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated     Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared     to menthol cigarettes (mCC) in healthy smokers.   "
62588|NCT02466399|"     This is an open-label, randomized, multi-center, active-controlled parallel-comparison of     POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary     open-angle glaucoma.   "
63435|NCT02455323|"     The present study aims to assess the quality of life of patients suffering from tension-type     headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study     design involved a factorial, randomized, double-blind, controlled study   "
62591|NCT02466360|"     Non-specific chronic lower back pain is a common pathology which is a real public health     problem. Around 84% of the population could have non-specific chronic lower back pain at     least once in their lives and 8% of that non-specific lower back pain could become chronical     (pain that would last at least 3 months). This proportion of patients represents 85% of the     costs related to this pathology.      Physical activity practice is involved in medical care for plenty of chronical diseases and     particularly for chronic lower back pain. In 2003, World Health Organization pointed out the     poor adhesion of patients with chronical diseases to medical prescriptions and the     after-effects it could have on illness evolution. Therefore, adhesion to physical activity     practice for patients with chronic lower back pain is one of the most challenging matters for     medical teams.      The aim of this study was to identify the brakes and levers of physical activity practice for     these patients. Sixteen individual interviews and four focus groups have been carried out on     patients with chronic lower back pain who were taken care of either by a rachis functional     restoration program or by primary care.   "
62592|NCT02466347|"     The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide     HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without charcoal     block.   "
62593|NCT02466334|"     It has previously been shown that nitroglycerine induces cluster headache attacks in episodic     cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore,     plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be     significantly higher during, but not before and after, an attack.      The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During     this latency period preceding the attack, no increase in CGRP plasma concentrations is seen.     CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as     monoclonal antibodies against CGRP are effective in migraine treatment.      Based on the above the investigators hypothesize the following:        1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks        2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks        3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks          more often than in ECH patients.   "
62594|NCT02466321|"     The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™     Inverse/Reverse System by analysis of standard scoring systems and radiographs.      Outcome data will be collected using the following standard scoring systems of which summary     statistics will be provided:        -  Constant and Murley Score to evaluate clinical parameters such as range of motion,          power, level of pain and functional ability.        -  SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of          twelve questions to assess the subject's physical and mental health status which must be          answered by the patient.   "
62595|NCT02466308|"     ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a     portable and wearable medical device which, when applied to various areas of the body applies     Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for     pain reduction, treatment of muscle spasm and joint contracture, and increasing local     circulation. This study will look at the use of therapeutic ultrasound to relieve pain and     enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.   "
62596|NCT02466295|"     The purpose of this study is to investigate whether the pressure controlled ventilation can     reduce gastric insufflation compared to the volume controlled ventilation in patients who     were mechanically ventilated with the i-gel.   "
62597|NCT02466282|"     It is well-known that non-optimal stent implantation associated with under-expansion or     incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a higher     incidence of restenosis and stent thrombosis. OCT-guided PCI with metallic stent has     previously been shown to be safe and feasible, resulting in better clinical outcomes compared     with angiography-only guided PCI. Everolimus-eluting bioabsorbable vascular scaffold (BVS;     Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone     which is coated with a more rapidly absorbed polylactic acid layer that contains and controls     the release of the antiproliferative drug, everolimus. BVS has a number of proposed     advantages over current metallic stent technology. These include elimination of chronic     sources of vessel irritation and inflammation, which can reduce the potential risk of late     scaffold thrombosis after complete scaffold bioresorption. Although the current generation of     the Absorb BVS have larger strut thickness of 150 μm compared with 80 μm of strut of Xience     stent, the acute recoil of the polymeric device was similar to that of metallic stent.     However, operators tented to use dilating devices less aggressively because of the concerns     about limitation in elongation-at-break of polylactide. Previous studies reported 20-30% of     under-expansion or malapposition with BVS, which would increase the risk of adverse events     including late stent thrombosis. OCT-guidance may improve more optimized scaffold placement     and also better outcomes. Therefore, investigators will compare OCT guidance and     angiography-only guidance for PCI with BVS regarding incomplete scaffold apposition and     neointimal scaffold coverage. Investigators are also going to compare these two strategies     regarding clinical outcomes with verification of the cut-off value by OCT-acquired uncovered     scaffold rate.   "
62598|NCT02466269|"     A new surgical approach, denoted as the supratemporalis approach, was designed to treat     diacapitular condylar fractures of the mandibular condyle.This approach prevented facial     nerve injury and did not increase the frequency of other complications. Therefore, the     investigators suggest this surgical procedure as a routine and safe approach to diacapitular     condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the     zygomatic arch.   "
62599|NCT02466256|"     This randomized clinical trial compares subjective performance during Intraocular lens (IOL)     implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL     implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision     using one of three injectors :      Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector     (Autosert). Further, the investigators also looked at incision integrity by comparing ingress     of trypan blue from the ocular surface into the anterior chamber.   "
62600|NCT02466243|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in     adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3     months treatment with hydroxychloroquine.   "
62645|NCT02465658|"     The presence of co-existence of cervical elongation in women of uterine prolapse may decrease     the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and     additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the     aim of this study is to investigate the risk factors of co-existence of cervical elongation     in uterine prolapse.   "
93462|NCT02062723|"     The efficacy and tolerability of Eptadone® in the context of a maintenance program will be     evaluated in an observational prospective, multicenter study, in heroin addicted patients.   "
62601|NCT02466230|"     This study utilizes resting state fMRI, arterial spin labelling imaging, diffusion tensor     imaging, structural MR-imaging, and MR-spectroscopy of GABA and Glutamate to probe the     antidepressant mechanisms of repetitive transcranial magnetic stimulation (rTMS). The above     imaging modalities will be acquired before and after an open-label 5 week course of rTMS for     depression in currently depressed individuals with treatment resistant depression. Changes in     functional, structural, and neurochemical markers will be investigated in rTMS responders and     nonresponders to elucidate mechanisms of plasticity that correlate with treatment response.     Additionally, functional, structural, and neurochemical signatures at baseline that correlate     with subsequent treatment response will be investigated.   "
62602|NCT02466217|"     The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure     inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory     diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with     IAD should be heuristic and help revise the nosography and the understanding of these     diseases.   "
62603|NCT02466204|"     A prospective, randomized, controlled study to explore the efficacy and safety of using     either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH)     300 international unit (IU) for the stimulation treatment of subjects undergoing controlled     ovarian stimulation prior to IVF.      The study is designed as a non-inferiority trial. The sample size for this trial of 400     subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint     of the number of oocytes retrieved.   "
62604|NCT02466191|"     Pendular nystagmus corresponds to an enduring to and fro eye oscillation without resetting     quick phases. The most common causes of acquired pendular nystagmus (APN) are multiple     sclerosis (MS) and focal brainstem lesions (oculopalatal tremor, OPT). Based on     pathophysiological hypothesis, pharmacological treatments of acquired nystagmus have been     thoroughly proposed over different publications of cases, series, reviews or expert opinions.     Acquired pendular nystagmus underwent the most rigorous treatment trials, leading to the     proposal of gabapentin or memantine as valuable drugs. Whether gabapentin and memantine are     effective in APN associated with OPT remains unclear, since none of the previous studies has     evaluated the effect of these medications in a group of OPT patients. However, this is an     important issue in prospect to a clinical use of these medications. In the current study, the     investigators aim is to evaluate the effect of gabapentin and memantine on the mean velocity,     amplitude and frequency of pendular nystagmus, as well as on visual acuity and     vision-specific health-related quality of life score, in a group of OPT patients   "
62605|NCT02466178|"     The purpose of this study is to evaluate the ability of the Serene RF System to effectively     improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3     months.   "
62606|NCT02466165|"     Multiple Sclerosis (MS) is the most common chronic inflammatory neurological disorder in     young adults. Due to heterogeneous symptoms, MS patients are often more inactive than healthy     controls, resulting in an inactivity related physiological profile. In healthy people,     physical inactivity can contribute to the development of an increased cardiometabolic risk     state including the combined presence of cardiovascular risk factors (increased cholesterol,     elevated blood pressure, body fat, glucose intolerance/insulin resistance, inflammation and     reduced heart function/autonomic control). In other populations, these secondary health     complications can be, in part, reduced by physical exercise, which is often used as the     primary treatment strategy. Since the impact of exercise on cardiovascular risk factors in MS     is unknown the present project first aims to explore this in a pilot trial and a controlled     research setting (during 12 weeks). A better understanding of the above described risk     factors and underlying physiological mechanisms will reduce the incidence of preventable     comorbidities in MS and will further improve the multidisciplinary treatment of MS patients     and MS rehabilitation in particular. Interestingly, the investigators already reported an     elevated prevalence of impaired glucose tolerance in MS, but it is not clear whether the     cardiometabolic state in MS is also impaired. Therefore, in a second part, the researchers     will explore whether MS patients present a higher risk to develop cardiovascular diseases, as     measured by the assessment of various cardiovascular risk factors, compared to healthy     controls.   "
62607|NCT02466152|"     This study will assess the systemic exposure and pharmacokinetic parameters of GSK2894512     following twice daily topical administration of 1% and 2% cream in adult subjects with AD,     and will provide information about the systemic safety as well as local safety and     tolerability following twice daily application to up to 35% body surface area (BSA) of     affected skin of subjects with AD. It will be an open-label, sequential study consisting of 2     cohorts. A cohort of 6 subjects (Cohort 1) will apply GSK2894512 (cream, 2%) to affected skin     on an area ranging from 15 to 35% of the total BSA for 20 days plus a final dose on Day 21.     Cohort 2 will consist of 6 subjects that will apply 1% cream. Cohort 2 will follow the same     procedures as Cohort 1.   "
62608|NCT02466139|"     The investigators conduct a prospective observational study on consecutive patients being     admitted to a tertiary care-centre with infective endocarditis. The investigators' primary     aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital     events, mortality and 6-month mortality.   "
62609|NCT02466126|"     The purpose of this study is to determine the effectiveness of a brief cognitive behavioral     therapy (bCBT) intervention for Veterans with depression delivered by mental health providers     located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and     Oklahoma City VAMCs.   "
62610|NCT02466113|"     Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is     still on debate.MicroRNA(miRNA) is a promising tool. Investigators invented a tool consisting     of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that was     effective to identify one should accept adjuvant chemotherapy or not. Here investigators     randomly assign patients to be assessed by classical pathological features or the miRNA tool     of determining who should accept chemotherapy. Disease free survival and overall survival are     the end points of observation.   "
62648|NCT02465619|"     The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015     to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion     criteria will be included in the study and will be categorized and evaluated. The patient     will followed over a period of 3 months.   "
62611|NCT02466100|"     This study proposes to evaluate, among adults with advanced heart failure (HF) and their     health care providers, the effects of a communication intervention designed to improve     patient-provider communication about goals of care (GoC). Patient activated GoC conversations     can result in providers' better understanding their patients' preferences for end-of-life     care. GoC conversations that occur over time may allow patients and providers to consider a     wider range of options earlier in the HF illness trajectory. Preliminary data suggests that     the proposed GoC intervention increases the occurrence and quality of patient-provider     communication about end-of-life care for advanced COPD. The proposed study will test the     effects of the GoC intervention compared to usual care, using a randomized, 2-group (N = 80,     n = 40/arm), repeated-measures design. Measures will be taken at a patient's baseline study     entry and after the next scheduled clinic visit. Specific Aim 1 is to evaluate change in     number of GoC conversations between patient and provider between the two groups. Specific Aim     2 is to examine whether the intervention increases patient quality of life, referrals to     palliative care, advance care planning, decreases depression and anxiety. Specific Aim 3 is     to describe the feasibility, acceptability, perceived benefits, burden, and implementation     success of the intervention in the heart failure clinic setting. Patients will be randomized     to the GoC intervention or to receive usual care. Patients in the GoC intervention group,     telephone coaching by a research nurse to help patients role-play talking with their HF     providers. Both patients and their providers, will be provided with summaries of     individualized, patient-centered information about patient preferences for communicating     about end-of-life care and patient self-identified barriers to and facilitators of     communication about end-of-life care with tips on how to initiate goals of care discussions.     Providers of patients in the intervention group will also be provided with patient-specific     prognostic information based on the Seattle Heart Failure Model. The GoC intervention will be     tested in a real-world clinic setting. This intervention is expected to be relatively     cost-effective and easily translated into general cardiology practice in the future. The     study is expected to make significant contributions to provision of earlier access to     palliative care in the advanced HF disease trajectory.   "
62612|NCT02466087|"     The objective of this project is to test the hypothesis that magnesium supplementation will     decrease depressive symptoms in adults.      This study takes place over 12 consecutive weeks. While the investigators will follow the     volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6     consecutive weeks. Volunteers will be randomly assigned to start the supplement at week 1 or     week 7. Volunteers will take two supplement two times a day for a total of 248 mg elemental     magnesium daily in the form of magnesium chloride. This amount of magnesium is less than the     tolerable upper limit of 350 mg per day. The supplements will be provided. Volunteers will be     asked to maintain their normal diet for the 12 weeks of the study.      The primary outcome measure is the PHQ-9 questionnaire, a validated measure of depression.     Secondary measures include the GAD-7 for Anxiety and side effects.   "
62613|NCT02466074|"     This study will evaluate how improved cerebral blood flow affects the way in which newly     formed MS lesions evolve and whether tissue repair is improved. Patients with multiple     sclerosis (MS) will be treated with acetazolamide in daily divided doses and obtain MRI to     determine how much and in which regions of the brain cerebral perfusion improves as well as     the extent to which tissue integrity is improved in these areas.   "
62614|NCT02466061|"     This randomized, controlled study evaluates the efficacy of weigh loss interventions in     endometrial cancer survivors, using novel technology-based weight loss platforms. This is a     multi-site, pilot feasibility study which will provide preliminary data to support a larger     NIH funded, mult-center trial.   "
62615|NCT02466048|"     This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting     material, in patients with spinal fusion.   "
62616|NCT02466035|"     Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic     disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk     allergy. The mechanisms of these effects are still largely undefined. The effect of LGG could     be related at least in part by the immunoregulatory role played by LGG. This probiotic can     balance the generation of cytokines possibly involved in IgE- or non-IgE-mediated cow's milk     allergy Interleulkin (IL)-4, IL-5, IL-10, IFN-γ , TGF-β, and TNF-Υ), which can contribute to     modulation of inﬂammatory processes. The investigators have demonstrated that children with     IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's     milk protein, and that tolerance is associated with a marked reduction of IL-13 production     and a concomitant increased frequency of IFN-γ releasing cells.      Epigenetics studies the heritable (and potentially reversible) changes of the genome     inherited from one cell generation to the next which alter gene expression but do not involve     changes in primary DNA sequences, highlighting the complexity of the inter-relationship     between genetics and nutrition. There are three distinct, but closely interacting, epigenetic     mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are     responsible for modifying the expression of critical genes associated with physiologic and     pathologic processes. The profile of epigenetic modifications associated with Th lineage     commitment, coupled with the sensitivity of the early developmental period, has led to     speculation that factors that disrupt these pathways may increase the risk of allergic     diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase     inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour     Th2-associated allergic differentiation. MicroRNAs are another structural components of an     epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has     been recently identified a specific Th2-associated microRNA (miR-21) that is critical for the     regulation of Th cell polarization. It has been previously demonstrated an inverse DNA     methylation pattern of cytokines involved in Th2 response (IL-4, IL-5) compared with     cytokines involved in Th1 response (IL-10, INF- y) in children with CMA acquiring oral     tolerance, with the most pronounced effects in those treated with Nutramigen LGG. The current     study will prospectively evaluate the effect of Nutramigen LGG and other commercially     available hypoallergenic formulas on epigenetic mechanisms that may be related to tolerance     acquisition.   "
62617|NCT02466022|"     Dexmedetomidine has demonstrated benefits both in sedation, and post-operative pain control,     with less respiratory depression than other common sedatives. Traditionally, dexmedetomidine     has been used with a large loading dose and infusion, which has been known to cause     dose-dependent negative side-effects (Abdallah et al., 2013). Single dose dexmedetomidine     produces less negative side-effects, but still effective sedation and reduced post-operative     pain (Jung et al., 2013). There is evidence for its benefits with general anesthesia but only     a few studies exist investigating its benefits when administered for sedation purposes with     spinal anesthesia, and no studies primarily examine post-operative opioid consumption. The     investigators hypothesize that single dose dexmedetomidine for procedural sedation will     reduce opioid consumption after total knee arthroplasty (TKA).   "
62618|NCT02466009|"     The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to     monitor the impact of treatment with regorafenib on the quality of life in older adults with     metastatic colorectal cancer.   "
62619|NCT02465996|"     Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be     helpful to improve the symptoms of FD.   "
62620|NCT02465983|"     This is a study in which pancreatic cancer patients receive a combination therapy with     CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide.     CART-meso cells are patients' own T cells that were modified in the laboratory to express a     receptor specific to the mesothelin protein. CART19 cells are patients' own T cells that were     modified in the laboratory to express a receptor specific to a protein called CD19. The CD19     protein is expressed on white blood B cells. CART19 cells are expected to attack the B cells     and impede the antibody response against CART-meso cells. The investigators hypothesize that     this combination therapy may prolong the duration of CART-meso cells in the body.     Additionally, one dose of cyclophosphamide may enhance engraftment and persistence of CART     cells.   "
62621|NCT02465970|"     Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life     expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery.     Neurostimulation, which can be an effective add-on treatment, is currently mainly represented     by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive     technique already used in other areas of neurology, may be efficient on some partial     epilepsies, in particular through the individual configuration of stimulation, made possible     by recent technological advances.      Main goal : To study the effect of transcranial electrical stimulation on the frequency of     seizures in patients with drug-resistant partial epilepsy.      Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24     hours following an individually configured TDCS session: responders in real TDCS vs placebo     stimulation.   "
62622|NCT02465957|"     Phase II study to determine the effects of aNK infusions in combination with ALT-803 in     patients with stage III (IIIB) or stage (IV) merkel cell carcinoma (MCC).   "
62623|NCT02465944|"     This study will be conducted to evaluate the safety, tolerability and efficacy of     intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with     moderate to severely active Crohn's Disease   "
62624|NCT02465931|"     The Decisional Capacity and Informed Consent in Fragile X Syndrome (FXS) project is for the     Eunice Kennedy Shriver National Institute of Child Health & Human Development,     1R01HD071987-01A1, and will provide the first comprehensive description of decisional     capacity of individuals with FXS; identify individual, family, and experiential factors     associated with variability in decisional capacity; determine the validity of caregiver and     expert ratings; and develop evidence-based guidelines for categorizing decisional capacity of     individuals with FXS. RTI will develop a methodologically rigorous and conceptually grounded     decision aid using digital technology to enhance participation of individuals with FXS in the     consent process.   "
62625|NCT02465918|"     Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic     pain not responsive to medication. An electrode is placed on the surface of the brain and     connected to a programmable battery in the chest.      The strength of stimulation can be individually adjusted by changing the voltage of     stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low     voltage will not provide pain control.      The aim of this study is to analyze the optimal stimulation timing parameters in patients     already implanted with MCS and have received good pain relief. The investigators wish to     cyclize on/off MCS in order to save the battery life of the stimulator and also decrease     stimulus habituation. The investigators hope to determine these timing parameters while     maintaining optimal pain relief.   "
62626|NCT02465905|"     Prospective study Main objective: to evaluate the efficiency and the security of two     protocols of immunotherapy (raw milk versus heated milk) in a cohort of children with     persistent Immunoglobulin E (IgE) mediated CMA (IgE-CMA).      Secondary objectives: to determinate if the enumeration of casein-specific IL-4- and     IL-13-secreting T cells could be a valuable biomarker of successful immunotherapy.   "
62627|NCT02465892|"     This study aims to explore whether cancer patients can benefit from completing the     Pillars4Life online coping program. This randomized control trial will have half its subject     completing the program and the other half receiving standard care in order to measure whether     the program is beneficial in dealing with stress, anxiety, and particularly chronic pain that     often accompany a cancer diagnosis.   "
62628|NCT02465879|"     There is accumulating evidence that early treatment leads to better outcomes for patients     with inflammatory arthritis (IA). Triage, which is the process of identifying the urgency of     a patient's disease state efficiently and correctly, may facilitate early referral to a     rheumatologist. Several studies have suggested that placing allied health professionals     (occupational therapists, physical therapists, nurses, etc.) in a triage roll may reduce wait     time for patients with suspected IA. The goal of this investigation will be to demonstrate     the system-level impact of an Arthritis Society extended role occupational therapist (OT) or     physical therapist (PT) working in a triage role in improving access to rheumatologists for     people with IA. In this study two groups will be observed: intervention and usual care as     determined by historical chart review. Wait times will be compared between both groups.   "
62629|NCT02465866|"     This study will compare the relative bioavailability of hydrocodone, acetaminophen, and     promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg)     manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5     mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5     mg/acetaminophen 325 mg) under fasted and fed conditions.   "
62630|NCT02465853|"     Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede     rehabilitation programs and the motor recovery of affected upper extremity. HSP was     associated with impaired daily life activities and prolong hospital stay after stroke.     Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs     injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff     injuries. Previous researchers reported that HA could provide pain relief, improved motion,     and increased daily activities. In this study, fifty subacute stoke patients will be     enrolled. These patients will be allocated into group A and B randomly. The patients in group     A received HA injection while patients in group B received normal saline injection. Patients     from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All the     patients will still receive rehabilitation programs of physical therapy and occupational     therapy. Each patient will receive physical, sonographic examinations, and stroke Specific     Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA     injection on pain relief, motor function recovery, and life quality in subacute stroke     patients with HSP before and after HA injection.   "
62646|NCT02465645|"     After successful screening of patients based on inclusion criteria, we will measure the     baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood     investigation including complete haemogram, kidney function test, liver function test,     prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan.     Routine complete physical examination will be done.   "
62649|NCT02465606|"     The primary objective for this study is to evaluate the safety of lebrikizumab compared with     Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic     Dermatitis (AD) that is inadequately controlled with TCS.   "
62631|NCT02465840|"     Hand injury is one of common occupational or traumatic injury at outpatient clinic of     rehabilitation department. The motor or sensory deficits after hand trauma including bony     fracture,tendon / nerve injury, joint stiffness, motion restriction, sensory impairment, or     pain lead to impaired upper extremity function, ability for daily activity, or quality of     life. Rehabilitation is a kind of therapy for disability after hand trauma. It could provide     pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma.     The investigators consider that there are some deficits in hand function and range of motion,     pain after injury, and some attenuation of brain functional MRI (fMRI) for hand motor     control. Therefore, optimal and early intervention of rehabilitation programs may have some     benefits for their hand functional outcome and improve the brain activities in fMRI images     for the hand motor control.      The aims of this study are to compare the differences in hand motor control area of brain     functional MRI (fMRI) between normal subjects and hand injury patients before treatment and     to investigate the improvement in brain fMRI activity and functional outcome after early     rehabilitation in hand injury patients.      The investigators will collect 40 patients with hand trauma after operation and 10 normal     subjects in this study. The 10 normal subjects were allocated in the control group. These 40     patients were randomly divided into 2 experimental groups: 20 patients in group A and 20     patients in group B.      In group A and B, the patients will perform immobilization and Kleinert programs     respectively. All patients will perform rehabilitation regimen with 2-3 sessions per week for     3-6 months. Before and after rehabilitation, all patients will receive physical examinations,     brain fMRI, and DASH questionnaire for daily activity.   "
62632|NCT02465827|"     The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided     blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours     post-operatively for patients undergoing unilateral primary total knee arthroplasty.   "
62633|NCT02465814|"     The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with     uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety     of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic     (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will     be supplemented.   "
62634|NCT02465801|"     The purpose of this study is to evaluate the dosages of recombinant human serum     albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing     neutrophilic granulocytopenia among chemotherapy patients.      Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte     colony-stimulating factor fusion protein with recombinant human granulocyte     colony-stimulating factor injection as a control.   "
62635|NCT02465788|"     The objective of this post marketing study is to further explore a variety of treatment     parameters in order to optimize the optical (laser) and electrical (RF) treatments over the     various skin types, when using a combination 755 nm alexandrite laser together with a bipolar     RF energy system, for the purpose of hair reduction.   "
62636|NCT02465775|"     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the     performance of the UltraShape treatment for non-invasive fat reduction by compare control and     treated flanks.      Study subjects will undergo UltraShape treatments on one randomized flank using the     U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated     and control) will be compared to baseline, as well as, one to each other   "
62637|NCT02465762|"     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the     UltraShape treatment for non-invasive fat and circumference reduction.      Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF     Transducer - 60 subjects.   "
62638|NCT02465749|"     The purpose of this study is to investigate the role of continuous oxygen therapy combined     with blue light deprivation in prevention and control of retinitis pigmentosa, in order to     find a new strategy of treatment for retinitis pigmentosa.   "
62639|NCT02465736|"     The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus     cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and     toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.   "
62640|NCT02465723|"     The purpose of this study is to find out if special blood tests and imaging scans can help     evaluate the effects of the radiation the patient receives as part of standard treatment. The     patient will undergo either stereotactic or conventional radiation treatment as determined by     the treating doctor. Previous evidence suggests that blood flow to tumors is affected by the     amount (dose) of radiation that it receives. This effect may be seen as soon as 1-2 hours     after the radiation is given. This study will evaluate if these changes can be seen and     measured by performing a special type of scan called Intravoxel Incoherent Motion (IVIM)     diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test. IVIM MRI is a research     exam which is similar to a standard MRI exam, with only a slight difference in the technical     parameters used to acquire the images.   "
62641|NCT02465710|"     The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse     remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who     underwent pelvic organ prolapse surgeries with and without mesh implantation in the     Department of Obstetrics & Gynecology of National Taiwan University Hospital.   "
62642|NCT02465697|"     Borderline Personality Disorder (BPD), a prevalent psychiatric disorder found in     approximately 2% to 6% of the population and 20% of hospitalized psychiatric patients, has     proven quite treatment resistant. This study is designed to determine whether patients with     BPD can be trained to improve their ability to regulate their emotions and whether this leads     to changes in how their brans regulate emotion.   "
62643|NCT02465684|"     There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet     in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like     operating time, blood loss, quality of prosthesis fixation in the bone, adverse events,     radiographic result, clinical score outcome, easy of rehabilitation etc. It is not     appropriate to rely on findings from the field of total knee arthroplasty.      It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with     regard to component fixation quality, component positioning and sizing, clinical outcome and     rehabilitation process.      Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the     medial compartment will be considered for participation.      Patients are then randomized for surgery with or without tourniquet. After an anteromedial     Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the     manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.      The following outcome parameters are assessed: 1)radiographic cement mantle thickness,     2)component position & sizing, 3)diolucencies, 4)score outcome and 5)parameters of early     Rehab.   "
62644|NCT02465671|"     The current study was designed to investigate the change of plasma thrombospondin-1 levels     and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients     with acute intracerebral hemorrhage.   "
62650|NCT02465593|"     This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of     PEP503(radio-enhancer).      There are 2 portions in this study.        -  Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this          phase to identify the recommended injection volume of PEP503 for intratumor injection.        -  Expansion phase (Part II): Following the confirmation of the recommended volume of          intratumor injection, 18 additional patients will be enrolled at the recommended volume          level to evaluate for efficacy.   "
62651|NCT02465580|"     Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,     which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by     the investigator's group, the investigators found that the Low-dose IL-2 was effective and     well tolerated in active SLE, and the effect was associated with selective modulation of CD4+     T cell subsets.      This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.      The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The     investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus     erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).   "
62652|NCT02465567|"     This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy     and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate     to very severe COPD.   "
62653|NCT02465554|"     The purpose of this study is to develop new approaches for screening astronauts for     cardiovascular risk during deep space missions.   "
62654|NCT02465541|"     This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle     change effects physical function and quality of life of endometrial cancer survivors. Gentle     yoga and dietary counseling may help improve physical function and quality of life for stage     I-II endometrial cancer survivors.   "
62655|NCT02465528|"     This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety     and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are     characterized by ALK genetic alteration (and/or overexpression in some diseases).   "
62656|NCT02465515|"     Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes     This study will test whether albiglutide affects the occurrence of major cardiovascular     events such as heart attacks or strokes and other important medical outcomes in persons with     type 2 diabetes, when used alone or added to other diabetes treatments.   "
62657|NCT02465502|"     To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks) of     regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory     to standard therapies and who were never exposed to antiangiogenic therapy.   "
62658|NCT02465489|"     The purpose of this study is to look at the pharmacokinetics of a new formulation of     deferiprone (deferiprone extended release tablets) under fed and fasting conditions.   "
62659|NCT02465476|"     The investigators want to demonstrate that a new organization with telemedicine could     rationalize the treatment pathway of patient suffering from rare skin disease. A diagnosis     and a personalised treatment pathway could be performed before the consultation in the     hospital.   "
62660|NCT02465463|"     Clostridium difficile infection (CDI) has increased worldwide in both frequency and severity.     It is the leading cause of hospital acquired infection in developed countries and has been     associated with at least 14,000 deaths per year in the United States. With 3 million cases/     year, the annual cost for treating the infection is exceeding 3 billion dollars. It can also     have a profound negative impact on quality of life.      The investigators believe that patients who are at high risk of relapse after a first CDI     episode would benefit from early fecal microbial transplant (FMT). The proposed study will     produce preliminary data regarding safety and efficacy and potential for cost effectiveness     for the use of early fecal transplant in those patients with their first episode of     non-refractory CDI who are predicted to have a high rate of recurrence based on previously     published risk factors. The investigators will be better prepared to test the efficacy of     this approach in a future multicenter clinical trial in a randomized controlled fashion.      The purpose of this study is to compare the effectiveness and safety of early fecal     transplant using donor stool from a healthy person in a group of patients who are diagnosed     with their first episode of Clostridium difficile infection and are predicted to have a high     chance of the infection returning against a similar group of patients who receive current     standard of care for treatment of C.difficile.      The investigators hypothesize:        -  that clinical remission rates at 12 weeks as noted by absence of clinical symptoms          and/or negative C.difficile stool polymerase chain reaction (PCR) will be greater in the          experimental arm compared to the control arm        -  that patients in the experimental group will have a low microbial diversity prior to FMT          but will exhibit a high microbial diversity after the FMT that resembles the respective          donor        -  that the microbial diversity will be diminished in both groups at the time of          enrollment, but the experimental group will exhibit a higher microbial diversity          compared to the control population at 12 weeks        -  that patients in both groups will exhibit poor quality of life at the time of          enrollment, however, the experimental group will demonstrate higher quality of life          compared to the control group at follow up after completion of treatment        -  that costs incurred by the experimental group will be less than the control group   "
62661|NCT02465450|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).   "
62662|NCT02465437|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.   "
62663|NCT02465424|"     The purpose of this study is to determine which Health Related Quality of Life (HRQoL) tools     patients with medullary thyroid cancer (MTC) find most helpful. The study will compare a     generic cancer QoL tool with those developed for thyroid cancer patients and neuroendocrine     tumour (NET) patients. The study will also evaluate clinicians' opinions on the clinical     usefulness of the QoL tools.   "
62664|NCT02465411|"     A keystone in preventing diabetic complications in patients with type 1 diabetes is good     glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels have been an     essential part of insulin dosing before meals. However, in recent years continuous glucose     monitoring (CGM) has become a treatment option to inform the patient when glucose levels may     be too high or low.      In some countries, including Sweden, CGM is reimbursed only when combined with continuous     subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a     history of repeated severe hypoglycaemia in adults with type 1 diabetes. This is based on     existing clinical trial data showing a beneficial effect on HbA1c when CGM is combined with     CSII. However, despite the fact that the majority of adults with type 1 diabetes are treated     with multiple daily insulin injections (MDI), studies on the effect of CGM in patients with     type 1 diabetes treated with MDI are sparse. Therefore, the investigators initiated the     CGMMDI trial, an ongoing, cross-over clinical trial including 161 MDI patients receiving CGM     over 6 months, followed by conventional therapy over six months, with a four-month wash-out     period in-between treatment. Evaluations include glycaemic control, hypoglycaemia, quality of     life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.      From a research or regulatory standpoint, long-term data on treatment effects are expected to     a greater extent today than in previous years, due to various reasons, e.g., to evaluate any     sustained beneficial effects over time, or long-term patient safety. Accordingly, follow-up     of treatment in an extension phase after randomized diabetes trials have become more common     over time, especially where many novel glucose-lowering treatments are concerned. Therefore,     the aim of the current study is to evaluate long-term effects of CGM in patients with type 1     diabetes treated with MDI. Patients who consent in an extension phase over 1 year of the     CGMMDI trial will receive CGM, and evaluations will be performed on sustained glycaemic     control effects, hypoglycaemia, glycaemic variability, quality of life, fear of     hypoglycaemia, treatment satisfaction, physical activity, and safety.   "
62665|NCT02465398|"     The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture     System by analysis of standard scoring systems and radiographs.      Outcome data will be collected using the following standard scoring systems:        -  Constant and Murley Score        -  Oxford Shoulder Score        -  EQ-5D (EuroQol)   "
62666|NCT02465385|"     Video capsule endoscopy is an important procedure that can be used by doctors to find     abnormalities in the small intestine, especially those that can cause bleeding. The procedure     uses a tiny wireless camera to take pictures of the digestive tract. The camera sits inside a     vitamin-sized capsule that a person can swallow. As the capsule travels through the digestive     tract, the camera takes thousands of pictures that are transmitted to a recorder worn on a     belt around a person's waist or over his/her shoulder. However, abnormalities can be missed     partly because the normal dark liquids present in the intestine can prevent abnormalities     from being recorded, hiding them from the physician who reviews the video.      The current method used to clear these dark liquids from your small intestine is to follow a     clear liquid diet and drink approximately 2 quarts of polyethylene glycol (Golytely®) the day     before the video endoscopy and take simethicone (a medication used to treat symptoms of gas     such as uncomfortable or painful pressure, fullness, and bloating) the morning of the test.      Some of the current preparations to clear these dark liquids are not able to entirely prevent     abnormalities from being missed and most have an unpleasant taste or involve drinking a lot     of fluid.      Linaclotide (Linzess®) is a medication approved by the Food and Drug Administration (FDA) for     the treatment of constipation and irritable bowel syndrome. It is not approved by the FDA for     use as an aid for clearing dark liquid from the small intestine prior to a video endoscopy.      A recent presentation at a medical meeting proposed using one-dose of linaclotide (Linzess®)     to improve cleansing of the small intestine for capsule endoscopy preparation to supplement     fasting and clear liquid diet.      This report claimed a noticeably better quality of small intestine cleansing and a 20%     shorter transit time for the capsule by taking one dose of linaclotide one hour before     patients swallowed the video capsule.      The purpose of this study is to assess the use of one dose of linaclotide in terms of the     total time it takes the capsule to move through the small bowel, and image quality as     compared to the current method. The results of this study will be compared to previous     patients who drank the preparation that is currently used   "
62667|NCT02465372|"     The purpose of this project is to develop a Comprehensive School Physical Activity Program     (CSPAP) training protocol, and test the feasibility, acceptability, and effectiveness of its     delivery in an elementary school setting.   "
62668|NCT02465359|"     The investigators are using self administered subcutaneous IG in patients with CIDP who     require IVIG. Safety, efficacy, and patient satisfaction will be examined.   "
62669|NCT02465346|"     Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety     and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site     for hyperacute treatment and transfer to the most appropriate target hospital. The effects on     reduction delays until different stroke treatments will be assessed. First estimations of     cost-effectiveness will also be performed.   "
62670|NCT02465333|"     Plantar heel pain is the most common problem of the foot. Plantar fasciitis is the leading     cause of this pain, accounting for 11-15% of all foot symptoms seeking professional care, and     occurs in 10% of the US population. The cause of heel pain can be from bone, soft tissue,     nerve, or systemic disease. The second most common cause of heel pain is fat pad atrophy,     followed by a combination of both fat pad atrophy and plantar fasciitis. [1-4] Fat pad     displacement may be seen in the heel as well.      Current treatments for plantar fasciitis include stretching and external support with     orthotics with the goal of reducing local pressure as well as tissue breakdown.[5] However,     patient compliance with extrinsic devices is challenging, and they may experience increased     friction, irritation and breakdown at a different location on the foot due to thickness of     the device in the shoe. Also, the patient must replace the device as soon as it breaks down     but the breakdown often goes unnoticed. Failure of conservative management may lead to     treatment with steroids or surgical intervention by endoscopic plantar fasciotomy, open     fasciotomy or excision of bone spurs. Injection of steroids can instigate or exacerbate     pre-existing heel fat pad atrophy. Autologous fat grafting to the heel may reduce plantar     pressures, and thus serve as a treatment for heel pain. Autologous fat grafting is currently     under investigation for a myriad of clinical scenarios.[6-19] Even though autologous fat     grafting is not yet an established therapeutic approach for the cited indications, some of     the reported results have been intriguing.[19] The variable resorption of fat, however, is an     important confounding factor in all these studies. Currently the literature reports fat     retention rates ranging from 25% to 80%.[20]      The specific aim of this study is to assess the adipose stem cell characteristics in patients     undergoing autologous fat grafting for heel fat pad atrophy and correlate these     characteristics with fat retention. Data from this study will help determine the     characteristics of the adipose stem cells in this population and open the door to additional     studies. This pilot study will also help build new collaborative efforts between Foot and     Ankle Specialists, Plastic Surgery, and Adipose Stem Cell Biologists, combining biomechanical     expertise with fat grafting and basic science expertise.   "
62671|NCT02465320|"     The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive gel)     will be effective as an acute-use anesthetic and can decrease the pain intensity associated     with gynecologic procedures using endometrial biopsy as a representative procedure.   "
62672|NCT02465307|"     Delirium, as a common complication of hospitalization, poses significant health problems in     hospitalized patients. Though about a third of delirium cases can benefit from intervention,     detecting and predicting delirium is still very limited in practice. A common     characterization of delirium is changes in activity level, causing patients to become     hyperactive or hypoactive which is manifested in facial expressions and total body movements.     This pilot study is designed to test the feasibility of a delirium detection system using     movement data obtained from 3-axis wearable accelerometers and commercially available camera     and facial recognition video system, in conjunction with electronics medical record (EMR)     data, to analyze the relation of whole-body movement as well as facial expressions with     delirium.   "
62673|NCT02465294|"     The purpose of this study is to evaluate the addition of two different probiotic     interventions to a comprehensive behavioral lifestyle intervention on body weight loss and     overall health in overweight adults.   "
62674|NCT02465281|"     The objective the preliminary study is:        1. to identify correlations between brain lesions and sensorimotor impairments in stroke.        2. to identify a potential effect of time on correlations between brain lesions and          sensorimotor impairments by comparing the results in patients with sub-acute stroke          versus patients with chronic stroke.        3. to identify possible patterns between brain lesions and sensorimotor impairments that          might increase our understanding in stroke recovery and guide further tailor-based          neuro-rehabilitation.   "
62675|NCT02465268|"     The purpose of this research study is to determine if an investigational dendritic cell     vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor     called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.   "
62701|NCT02464930|"     The primary purpose of this study is to test new methods to diagnose BE in time before it     turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor     the disease so that complication such as cancer can be diagnosed early. The two new methods     the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The     investigators will collect blood, bile and cells from the food pipe and stomach and measure     for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers     could help the doctors figure out which patients are at increased risk for cancer of the     esophagus.   "
62676|NCT02465255|"     Acute abdominal pain is a frequent symptom in children admitted to the emergency department .     In the past the fear of masking a surgical condition has justified withholding analgesia in     patients with acute abdominal pain. By the 2000s, some clinical trials established that     opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome     in children with acute abdominal pain. Despite this, acute abdominal pain is still     undertreated in this setting. Published paediatric trials studied the effect of opioid     analgesia administered by parenteral route or by mouth. To the best of our knowledge no study     investigated the effectiveness of sublingual analgesia.      The purpose of this randomized controlled trial is to assess the effectiveness of three     different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in     children complaining of acute abdominal pain.   "
62677|NCT02465242|"     Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the US. The CDC     states that 1.7 million people sustain a traumatic brain injury each year, with death     occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly     require hospitalization. The costs of TBI can be devastating to our society, with the 2010     economic cost estimated to be approximately $76.5 billion. 90% of this cost involves fatal or     hospitalized brain injured patients. Furthermore, survivors of traumatic brain injury have     high rates of institutionalization, readmission, and disability.      The prediction of prognosis in severe TBI is a difficult problem for physicians. Prognosis     evaluation in the acute phase of care varies widely among physicians caring for these     patients[3]. With prognosis often in doubt, physicians have difficulty leading families and     patients toward the most appropriate treatment which often leads to expensive testing and     patient management. The Brain Trauma Foundation has recommended several early indicators of     prognosis in severe TBI, including age, hypotension, CT scan features, Glasgow Outcome Scale     score, and pupillary diameter with light reflexes. Pupillary diameter and light reflexes have     been extensively studied, however accurate measurements of these prognostic factors have not     been performed due to a lack of standardized measuring procedure.      A new device has been validated to measure both pupil size and reactivity using infrared     pupillometry. This device has also been studied to create the Neurological Pupil Index (NPi)     as a measure of pupillary reactivity. The NPi has been shown to correlate with intracranial     pressure readings, however there are no studies correlating the pupillometer findings with     outcome measures in TBI. This study will prospectively evaluate the pupillometer readings of     pupillary size and reactivity (NPi) to test the hypothesis that the NPi is a realiable     predictor of 30-day outcomes in patients with severe TBI.   "
62678|NCT02465229|"     Biliary strictures present a diagnostic and therapeutic challenge to clinicians due to     unsatisfied accuracy of sampling modality. The major problem is very difficult to discern     malignant from non-malignant strictures, such as patients with primary sclerosing cholangitis     (PSC). With the poor prognosis and high mortality rate of advanced stage of     hepatopancreaticobiliary malignancies, early and accurate diagnosis impacts patients' outcome     and possible surgical candidacy. Therefore, a pre-operative determination of malignancy to     help plan appropriate treatment is highly desirable.      Before 2000s, several diagnostic modalities, including laboratory tests, ultrasonography     (US), computed tomography (CT) scan, cholangiography by percutaneous transhepatic     cholangiography endoscopic (PTC) and endoscopic retrograde cholangiopancreatography (ERCP),     and brushing cytology disclosed 13% to 24% false positive rate for suspicious malignant hilar     strictures. Compared to recent studies, ERCP brushings still suffer from low sensitivity     (41.6% ± 3.2% (99% CI)) and negative predictive value (58.0% ± 3.2% (99% CI)). In order to     increase diagnostic accuracy, at least two sampling methods, including brushing cytology,     biopsy, and fine-needle aspiration is therefore recommended. One article showed multimodal     tissue-sampling (Brushing + Biopsy + Fine-needle aspiration) increased the sensitivity for     diagnosis of malignant biliary stricture to 62%. However, no any literature demonstrate the     best sequence of combined sampling modalities to yield the highest diagnostic accuracy.     Besides, the role of stricture dilation before or after different tissue sampling modality is     still uncertain.      In this study, the investigators want to compare stricture dilation before or after     multimodal tissue-sampling, including brush cytology, intraductal suction and forceps biopsy     for the diagnosis of malignant biliary stricture and also assess which kind of the sequence     of combined tissue-sampling modalities could offer the highest diagnostic accuracy.   "
62679|NCT02465216|"     The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE     vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful     completion of TB treatment with confirmed bacteriologic cure, in preparation for a future     Phase 2b prevention of TB recurrence trial in the same population.   "
62680|NCT02465203|"     Follow-up for viral activity, changes in liver function and safety in patients with no SVR24     in feeder studies   "
62681|NCT02465190|"     This is a case-control study embedded in a surveillance system to determine the effectiveness     of antenatal maternal influenza vaccination against laboratory-confirmed influenza-associated     hospitalised illness in infants <6 months of age.   "
62682|NCT02465177|"     Unhealthy alcohol use is present in up to 38% of the 4 million patients admitted to an     American intensive care unit (ICU) each year in the US. Despite the high prevalence of     unhealthy alcohol use in ICU survivors, routine interventions targeted at reducing alcohol     consumption, alcohol-related consequences, and illness related to alcohol are not currently     part of the multidisciplinary approach to critical care. Although screening, brief     intervention, and referral to treatment (SBIRT) has been described in several healthcare     settings, it fails to address common characteristics of medical ICU survivors including high     rates of alcohol use disorders, cognitive dysfunction, psychiatric comorbidities, and     intimate involvement of friends and family. This study uses a qualitative approach to further     understand the needs of medical ICU survivors with unhealthy alcohol use. The investigators     hypothesize that there are common, modifiable barriers to improving alcohol-related outcomes   "
62683|NCT02465164|"     The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in     conjunction with low dose oxytocin is more effective at shortening labor induction times than     the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly     divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by     either Resident or Attending Physicians and left in place for 12 hours (protocol) in both     groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will     be used for the remainder of the induction per current hospital protocol. Time to delivery,     mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal     heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be     recorded.   "
62684|NCT02465151|"     The primary objective of this trial is to identify how much protein is required at breakfast     to promote positive whole body protein balance over the following 9h period.   "
62685|NCT02465138|"     Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis.     Determine if IV ketorolac provides improved post-procedure analgesia.      Determine if systemic mediators of inflammation are reduced in patients receiving IV     ketorolac following ERCP.   "
62702|NCT02464917|"     The purpose of this study is to compare umbilical cord gases in subjects receiving oxygen at     10L/min via simple facemask to subjects receiving room air in those presenting for scheduled     cesarean sections.   "
62703|NCT02464904|"     Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant     pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory     changes, resulting in the induction of anti-tumor immunity?   "
62686|NCT02465125|"     BACKGROUND        -  Vascular surgical patients often receive red blood cell (RBC) transfusions in the          peri-operative period        -  RBC transfusion may lead to improved outcome but on the other hand the intervention may          be harmful        -  Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below          5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain          hemoglobin levels above 6 mmol/L        -  A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC          transfusion in patients undergoing vascular surgery.        -  A trial examining the effect of RBC transfusion on tissue oxygenation is used to test          the trial-design and feasibility for a trial evaluating post-operative mortality and          morbidity.   "
62687|NCT02465112|"     TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors     after complete surgical resection of liver metastases treated with In111-Pentetreotide-based     adjuvant radiotherapy.      In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The     objective is to target residual tumor cells and/or micrometastases which escaped surgical     resection. Given the poor prognosis associated with recurrence, this treatment should prevent     relapse.   "
62688|NCT02465099|"     The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for     soft tissue removal from vertebral surfaces. The aim of the present study is to compare blood     loss in multilevel PSF surgeries in patients with adolescent scoliosis (idiopathic or     neuromuscular) done with ED or with UD. Blood loss will be estimated by major intraoperative     surgical Stage (1 and 2) and postoperatively (until discharge). Additionally, the study will     assess the possible influence of the device use in secondary perioperative outcomes.   "
62689|NCT02465086|"     The purpose of this study is to investigate the correlation and the causality direction     between mastering linguistic tests and second-order reasoning tasks in the autistic     population. Linguistic tests include two types of tasks: 1. Mastery of multiple embeddings or     recursion and 2. Mastery of dialogue particles. Second-order tests include standard     false-belief tasks.   "
62690|NCT02465073|"     Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel     (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial     infection at the wound site.   "
62692|NCT02465047|"     Background: Epilepsy and nonepileptic attack disorder (NEAD) are chronic conditions that     cause many patients to experience a great degree of stress in their everyday lives. Patients     have also reported stress as the commonest trigger of their seizures, and animal studies     suggest that stress can make seizures worse. A self-help intervention that would help people     manage the stress they experience could therefore improve their quality of life and have     positive effects on the frequency of their seizures.      Research Question: The study evaluates whether a self-help intervention in the form of a     brief booklet can improve the quality of life and reduce the levels of stress of people who     experience seizures. In addition, the study will explore the associations between seizure     severity and frequency, physiological and self-reported stress, and anxiety and depression.      Design: The researchers are recruiting patients attending the Outpatient Neurology Clinic at     the Royal Hallamshire Hospital and measure their quality of life and stress levels before,     one month and two months after they have been given the self-help stress reduction booklet.     The researchers will measure the changes in quality of life and stress levels using     questionnaires and saliva samples.   "
62693|NCT02465034|"     The purpose of this study is to examine how different areas in the brain interact with each     other and how using brain imaging and brain stimulation approaches can influence these     interactions.   "
62694|NCT02465021|"     The goal of the proposed research is to investigate the effects of novel snack products     differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and     short-term appetite control in healthy adults.   "
62695|NCT02465008|"     The purpose of this study is to determine whether levobupivacaine is effective in the acute     postoperative pain treatment in periprosthetic breast augmentation   "
62696|NCT02464995|"     The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a     severe asthmatic population with frequent exacerbations.      This will be a single center randomized and controlled study. Thirty subjects with severe     asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic     corticosteroids >3 days each in the previous year) will be randomized 1:1 to either the     thermoplasty group (bronchial thermoplasty and medical management) or control group (medical     management only).   "
62697|NCT02464982|"     Mammary reconstruction replaces total skin transplant, which may causing patient discomfort.     It is a simple, painless and reproductible technology that avoids consequences and     complications related to transplant. Tattoo helps patients to return faster to the normal     life and close more easily the cancer episode.      The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola     tattoo realized following standard care.   "
62698|NCT02464969|"     To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring     anticoagulation for the treatment of a VTE.   "
62699|NCT02464956|"     No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such     as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC     will offer valuable source of tissue for transplantation in these forms of AMD and may form     basis for a future treatment option in terms of cell transplantation.   "
62700|NCT02464943|"     The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness     data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type     B aortic dissection.   "
62704|NCT02464891|"     This study evaluates the effect of CCX168, a C5aR Antagonist, Oral Administration on Ex Vivo     Thrombus Formation and Disease Activity in ten patients with diagnosis of Atypical Hemolytic     Uremic Syndrome with or without genetic abnormalities in the complement system or     thrombomodulin, on stable chronic extracorporeal or peritoneal dialysis therapy since at     least 6 months.   "
62705|NCT02464878|"     Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured     islets. Patients will receive three times a week AAT infusions in the peri-transplant period     for three weeks.   "
62706|NCT02464865|"     This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.   "
62708|NCT02464839|"     This study was designed to demonstrate the prevalence of onychomycosis in hallux valgus     patients. Additionally, all the prevalence of tinea pedis, the pattern of clinical     manifestations, risk factors and coexistence foot deformities with hallux valgus were     observed and recorded.   "
62709|NCT02464826|"     This study was designed to demonstrate the efficacy of this product in non-dermatophyte     (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.   "
62710|NCT02464813|"     This study aims to evaluate the incidence of longterm pain after spinal fusion surgery in     children and adolescents. In the second part of the study a randomized double-blind clinical     trial will be conducted. We compare the effect of pregabalin versus placebo on postoperative     pain and oxycodone consumption. We will also be able to evaluate the effect of pregabalin on     neurophysiological monitoring during surgery.   "
62711|NCT02464800|"     The medical records of 393 eyes of 326 patients with severe proliferative diabetic     retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in     174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome     and incidences of intraoperative and postoperative complications were compared.   "
62712|NCT02464787|"     Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study     extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed in     subjects who increased their intake of fruits and vegetables. The scores were determined     using the Raman Spectroscopy. In that study subjects were assigned to one of four groups     based on their baseline SCS. For unknown reasons, the groups with the highest and lowest     baseline SCS failed to show an increase whereas the two intermediate groups did. One possible     explanation might be that intakes varied more than expected and was not obvious due to     self-reporting of intake of fruits and vegetables with different contents.   "
62713|NCT02464774|"     RATIONALE: Triple-negative breast cancer (TNBC) is an aggressive subtype shown to have a high     risk of locoregional recurrence (LRR) and distant metastasis (DM). The equivalent impact of     breast-conserving therapy (BCT) and mastectomy on disease-free survival in patients with     early breast cancer has been established by a number of large randomized controlled trials     and meta-analysis. However, ongoing dispute exists on whether TNBC is a good candidate for     BCT.      PURPOSE: This prospective, randomized, open, single-center Phase III clinical study is     conducted to compare efficacy and safety of breast-conserving therapy and mastectomy in     treating Chinese patients with early TNBC.   "
62714|NCT02464761|"     An estimated 10 percent of primary breast, prostate, lung, thyroid and renal cell tumors     metastasize to the spine. The majority of these tumors are detected before surgical     intervention is required and most patients receive radiation therapy for symptomatic relief.     Complete pain control, duration of pain control, high recurrence rates and soft tissue     complications make radiation a less than ideal treatment. Also, pre-operative radiation     therapy is a significant negative predictor for surgical outcomes. To improve the treatment     options for patients with advanced cancer with spinal lesions the research team investigated     a new minimally invasive therapy known as photodynamic therapy (PDT) that targets metastatic     spine lesions with limited side effects. PDT involves the use of a photo-activated     chemotherapeutic agent, given intravenously that when stimulated by non-thermal     wavelength-specific light allows for selective ablation of tumor tissue. The light is     delivered to the spine through small fiber optic cables using a diode laser. By combining     canine and porcine studies the investigators have strong evidence to support that PDT is both     safe and effective for the treatment of metastatic tumors in the spine. PDT is targeted,     repeatable, minimally invasive and has limited local and systemic side effects. Its use would     enhance the treatment options for patients with advanced stage cancer. The goal of the     present study is to demonstrate that PDT can be safely and effectively given to treat spinal     metastases in patients with advanced stage cancer who have multiple lesions or who have     failed radiation or surgical intervention. The effectiveness of this treatment will be     determined through clinical and radiographic endpoints along with recurrence and survival.     The investigators intend to demonstrate that PDT is a minimally invasive method with low     morbidity and mortality by which spinal tumors can be ablated and later stabilized through     vertebroplasty, optimizing quality of life and providing effective treatment.   "
62715|NCT02464748|"     Motor neurone disease (MND) is a rare but debilitating neurological condition that causes     paralysis of the body's muscles leading to severe disability and eventually death. Patients     often struggle to travel the long distances to specialist clinics to receive the care they     require whilst this expert care is often unavailable in the community. Telehealth has the     potential to enable a specialist team to monitor the health and wellbeing of patients and     their carers whilst they are at home. This could improve the patient's health, improve the     quality of life of both patients and their carers, and lead to more effective use of health     resources.      This is a randomised controlled pilot study that will involve 40 patients who are cared for     by the Sheffield Motor Neurone Disease care centre and their main informal carer (a total of     80 participants). Half of the participants will use the telehealth system for a minimum of     six months and maximum of eighteen months and information will be collected from patients,     carers and their care team. This will include collecting clinical outcome measures, health     resource use and the opinions and experience of using the system. All participants will     continue to receive their usual care.      This is a pilot study. It aims to determine the feasibility and acceptability of the     telehealth system to patients, carers and their health care providers. It also aims to     determine how a larger trial could successfully evaluate the clinical and cost-effectiveness     of the system.   "
62729|NCT02464566|"     With low carbohydrate dietary approach for both arms, the investigators will examine the     effectiveness of 12-weeks intensive lifestyle intervention program provided in individual     sessions in primary health care obesity clinic in Jeddah with aim to achieve 5% reduction of     baseline weight for experimental participants in comparison with active comparator group     (only one health education session).   "
69316|NCT02378480|"     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared     to linezolid in the treatment of adults with acute bacterial skin and skin structure     infections.   "
62730|NCT02464553|"     In this prospective multi-centre double-blind trial the effect of the X-ray examinations     controlled periradicular therapy should be examined in (approximately 300) adult patients     with low back pain pain caused by foraminal stenosis radiculopathy or spinal stenosis.      A periradicular therapy (PRT) is a special radiological, low-risk therapy for chronic back     pain caused by wear and tear of the cervical, thoracic, and lumbar spine or a herniated disc     or disc bulge. Partially pain might also radiate to the hips or extremities and cause     radicular symptoms.   "
62731|NCT02464540|"     The aim of this randomized clinical trial is to evaluate the influence of luting agent,     thickness and color of laminate veneers (LVs) and color of dental substrate on the optical     properties of LVs.   "
62716|NCT02464735|"     Mechanically ventilated patients in the Intensive Care Unit (ICU) are highly susceptible to     sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor     sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold     standard method for evaluating sleep quality and quantity). Discontinuation of mechanical     ventilation should be considered as soon as possible when a patient's condition starts to     improve. A patient's ability to be weaned from the mechanical ventilator can be assessed     using two step approaches including a Rapid Shallow Breathing Index (RSBI) calculation then a     spontaneous breathing trial (SBT) to determine the likelihood of success or failure before     considering endotracheal extubation. The rate of weaning failure from the first SBT attempt     has been reported to be 35-55%. The reason for weaning failure may be complex and     multifactorial. An association between sleep disruption and weaning outcome has never been     studied. The goal of this study is to look for an association between poor sleep quality and     failure of a weaning attempt.      This study is an observational, physiological study investigating sleep quality and quantity     in patients who will be weaned by recording standard PSG (from 17:00 to 08:00) at night     before a weaning attempt. Sleep characteristics of patients failing or passing the weaning     attempt will be compared. In addition, we will compare sleep patterns before and after     endotracheal extubation.   "
62717|NCT02464722|"     During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension     is essential in order to increase the visibility in the operative field and reduce the risk.     This study is comparing of dexmedetomidine and remifentanil before epinephrine local     injection for controlled hypotension during ESS.   "
62718|NCT02464709|"     This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®)     and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural     daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be     randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL.     Result of the treatment is assessed with clinical examination 12 months after treatment. The     investigators will also compare delayed skin reactions after treatment and cost-effectiveness     of both photosensitizer creams.   "
62719|NCT02464696|"     The goal of this clinical research study is to learn whether using early non-invasive     positive pressure ventilation (NIPPV), a method of delivering oxygen using a mask, or high     flow oxygen (using a tube with 2 prongs placed in the nostrils) is better at improving the     amount of oxygen in your blood, reducing shortness of breath, and the need for intubation     (placement of a tube in the windpipe) in patients with blood cancer and hypoxemia.   "
62720|NCT02464683|"     Tuberculosis (TB) is the second largest infectious disease that causes death in the last 4     centuries in all the world. Observational studies found an association between vitaminD and     TB, suggesting a potential therapeutic role of vitaminD supplementation in patients with     active tuberculosis. The hypothesis is that the administration of vitaminD is associated with     changes in the levels of cytokines in patients with tuberculosis treated with first-line     drugs. The aim of this study is to evaluate the effect of vitaminD supplementation on the     clinical course, the time of negative smears and cultures, and the effect on the immune     response in patients with pulmonary tuberculosis (TBP).   "
62722|NCT02464657|"     The goal of this clinical research study is to find the highest tolerable dose of nivolumab     that can be give in combination with idarubicin and cytarabine in patients with MDS and AML.     The safety and effectiveness of this drug combination will also be studied.   "
62723|NCT02464644|"     Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this     study is to provide data regarding the frequency of common health conditions and the     tolerability of therapies in HHT by using a questionnaire.      This will be filled in by both people with HHT, and controls who will be members of the     general population without HHT.      The questionnaire has been designed primarily for web based entry, but can also be circulated     in paper format on request   "
62724|NCT02464631|"     In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated     HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary     Sciences hospital will be included and those patients meeting the entry criteria received     treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin     administered orally twice daily, with doses determined according to body weight(600 mg daily     in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg,     and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration,     patients would be randomized in either of the 3 treatment groups -        -  Group 1 - Sofosbuvir + Ribavirin x 24 weeks        -  Group 2 - Sofosbuvir + Ribavirin x 36 weeks        -  Group 3 - Sofosbuvir + Ribavirin x 48 weeks   "
62725|NCT02464618|"     Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The     overall goal of this proposal is to evaluate the effect of directly involving a social     contact (chosen by the patient) on completion and quality of out-patient endoscopy     recommended for the patient by his/her primary care physician, or after scheduling by the     gastrointestinal endoscopist.      Improved adherence and better quality of procedures are postulated with involvement of social     contacts.   "
62726|NCT02464605|"     This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of     a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with     elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily     soluble allantoin that is then excreted.   "
62727|NCT02464592|"     The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial     lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung     disease.   "
62728|NCT02464579|"     The objective of this study is to measure the breastfeeding success for all preterm and term     newborns in our department of neonatology during the hospital stay and at the age of six     months.   "
62769|NCT02464046|"     The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus     placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple     dose administration to participants with insomnia disorder without psychiatric comorbidity.   "
62732|NCT02464527|"     The purpose of the current study is to deliver the SSP procedure to children diagnosed with     autism that do not have vocal language. The study will also aim to gather data in the natural     environment using a voice recorder.   "
62733|NCT02464514|"     The hyperghrelinemia of children with PWS provides a unique model by which to explore the     hormonal and metabolic effects of orexigenic hormones in normal and pathologic conditions. An     important question to be addressed by this proposed research includes the macro-nutrient     regulation of ghrelin and PYY in obese children and children with PWS. As ghrelin antagonists     are considered potential future anti-obesity agents, it is essential to gain understanding of     the developmental, nutritional and hormonal regulation of this important orexigenic hormone     in children.   "
62734|NCT02464501|"     The purpose of this study is to assess the safety and efficacy of paclitaxel administration     using the occlusion perfusion catheter (OPC) for the prevention of restenosis in     infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions,     and in-stent restenosis.   "
62735|NCT02464488|"     Several new oral direct anticoagulants have been recently marketed. However, only a few,     limited, studies have provided data about the pharmacology of new oral direct anticoagulants     in older persons. This study try to better define wether the pharmacology of each of these 3     drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very     older patients (over 80) and to which extend. The investigators also try to characterize the     main determinants (age, weight, renal function, co-morbidities, etc) of the variability     observed between individuals in their response to he drugs studied. The method employed is a     population pharmacokinetic/pharmacodynamic study.   "
62736|NCT02464475|"     Recent evidence suggested that the anterior insula cortex seems to be the main site of     interoception. Several studies showed an association between change in insula function and     interoception, bodily perception and consciousness in subjects with chronic pain. Although     osteopathic research has been demonstrated to be effective in reducing pain, studies     exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the     present study is to explore the extent to which osteopathic treatment could modify     interoception parameters both measuring brain functional connectivity and clinical     questionnaires.   "
62737|NCT02464462|"     The purpose of this study is to investigate the effect of vitamin D3 and calcium     supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic     patiens.   "
62738|NCT02464449|"     This study will evaluate a new approach for back pain care management using artificial     intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services     automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard     care but with less clinician time.   "
62739|NCT02464436|"     hRPC is a cell therapy for retinitis pigmentosa. This is a first-in-human, dose escalation     study in which participants with retinitis pigmentosa will receive a single subretinal     injection of hRPC cells in one eye to evaluate safety and tolerability.      Participants will be followed for one year to evaluate the safety and tolerability of hRPC     Additional testing will seek to establish any preliminary efficacy from hRPC.   "
62740|NCT02464423|"     Like most of sub-Saharan Africa, Rwandan youth are the epicenter of the AIDS epidemic,     accounting for 40% of new infections. Antiretroviral (ART) adherence is a global health     priority, but Rwandan youth are more than twice as likely to be on second line therapy than     adults, and with a median population age of 18.7 years old, adherence is essential for     Rwanda's future. Resources to provide youth-centered medical and psychosocial care are     limited in Rwanda, and young people with HIV face many obstacles to adherence, namely the     long-term consequences of genocide, depression, and gender-based violence, as well as     logistical issues, negative attitudes, and insufficient parent/caregiver support. Preliminary     data underscore the utility of culturally-adapted, trauma-informed cognitive behavioral     therapy (TI-CBT) in reducing depression and traumatic distress among youth and adults in     Rwanda. This project proposes a 2-arm randomized controlled trial (RCT) to test and compare     the efficacy of adherence-enhanced Trauma Informed Cognitive Behavioral Therapy (i.e.,     TI-CBTe) to usual care in increasing ART adherence among Rwandan youth from two clinics     caring for the largest number of youth with HIV in Rwanda. This proposal answers a compelling     need for innovative programs to increase ART adherence among HIV+ youth. If effective, the     study will build Rwanda's capacity to provide much needed services; and, involvement by the     Rwanda Biomedical Center will ensure wide dissemination.   "
62770|NCT02464033|"     The objectives of this study is to:        -  Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept        -  Evaluate how the above mentioned treatments influence the immune system and endogenous          insulin secretion   "
62742|NCT02464397|"     The purpose of this study is to compare vascular healing of the stented segment after     deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS)     and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes     requiring percutaneous coronary intervention.      Patients treated with BAS will be treated with DAPT for at least 4 weeks after the procedure     followed by aspirin alone, while patients in the EES group will be treated with DAPT, at     least for 6 months post procedure. In addition, this study will collect initial information     about the safety and effectiveness of the BAS in comparison with EES group at 30 days, 6     months, and 12 months.   "
62743|NCT02464384|"     Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the     predictive value of US alone and in combination with cartilage biodegradation markers on     radiographic progression (change in Ratingen score)      Secondary objectives:        -  Correlation of ultrasound synovitis score and clinical disease activity score        -  Determination of the sensitivity of ultrasound erosion detection compared to MRI        -  Assessment of the value of including tenosynovitis assessment for predicting          radiographic progression        -  Assessment of the predictive value of ultrasound synovitis score at baseline for the          need to install biologic DMARDs   "
62753|NCT02464254|"     The investigators will conduct a 1-year prospective and randomized study to evaluate the     initial efficacy of positive affect vs. an educational control to motivate physical activity     in older adults with high burdens of chronic disease.   "
62917|NCT02462109|"     Nodding Syndrome is an enigmatic neuropsychiatric syndrome affecting children and adolescents     mostly in Eastern Africa. The symptoms of Nodding Syndrome and catatonia seem to overlap. The     researchers' objectives in this study were to investigate the presence and types of catatonic     symptoms in children with Nodding Syndrome and observe their response to one or two doses of     lorazepam, the first-line treatment for catatonia.   "
62744|NCT02464371|"     ICU acquired muscle weakness (IAMW) is a common disease that is associated with high     morbidity and mortality. Patients with septic shock are particularly at risk.      The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council     score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only     usable in sufficiently awaken patients.      Several studies have highlighted the role of microRNAs in regulating physiological processes     and diseases related to the skeletal muscles. To date, no study was interested in IAMW.      The aim of this study is to compare the microRNA detection kinetics on the appearance of     IAMW.      In septic shock patients, the kinetics of nine microRNAs will be compared between two groups:     those with IAMW (IAMW + group) and those without IAMW (IAMW - group).   "
62745|NCT02464358|"     HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's     risk for cervical cancer, vaccination rates remain inadequate. This study explored the     utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV     vaccination knowledge, motivation, and behavioral skills among college aged women.   "
62746|NCT02464345|"     The investigators have developed a new integrated therapy, namely a Healthy Approach to     weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral     weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat     ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle,     the role of food and physical activity in mood regulation, and revised but clinically     meaningful goals for weight loss. The investigators propose a randomized controlled trial     (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two     main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be     conducted in Sydney and in São Paulo with a one year follow-up.   "
62747|NCT02464332|"     Many types of cancer are primarily treated with surgery and patient survival is directly     related to the extent to which the tumor is able to be removed. It is often difficult for     surgeons to distinguish tumor tissue from normal tissue, and failure to surgically remove a     cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's     chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in     significant morbidity. The investigators hypothesize that BLZ-100 will improve surgical     outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer     cells that have spread to other sites in real-time as they operate. This is a safety study to     assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.   "
62748|NCT02464319|"     Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by     keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations     may develop. Several immunomodulating agents have been attempted in the treatment of pSS     without achieving satisfactory results. Currently, there is no approved systemic treatment     for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune     diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that     low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test     the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a     single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the     effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized     controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).   "
62749|NCT02464306|"     A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ     Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with     a first-episode of Clostridium difficile infection (CDI).   "
62750|NCT02464293|"     This is a pilot study to see whether mindfulness-based cognitive therapy, which is a type of     psychological therapy, is able to improve the psychological wellbeing of people who have the     gene for Huntington's disease.   "
62751|NCT02464280|"     The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The     expected value of this project is the definition of proven indications for tomosynthesis,     which allow replacing CT. Specific goals are the early detection of pulmonary consolidations     / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.   "
62771|NCT02464020|"     The goal of this study is to assess if oral vancomycin can restore the normal bile acid     metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease.     Study participants will provide blood and stool samples in order to evaluate the bile acid     metabolism before a short course of vancomycin and then again after to assess for change. The     investigators will also assess the blood and stool of healthy people, and people with IBD     (without PSC) as a control group.   "
62803|NCT02463604|"     This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast     medium-induced nephropathy in a population of high risk patients undergoing coronary     angiography. Half of participants will receive a preconditioning procedure while the other     half will receive a sham procedure.   "
95677|NCT02033798|"     The purpose of this study is to determine whether medical treatment for bladder outlet     obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.   "
62752|NCT02464267|"     The aim of this study is to develop a reliable and valid instrument to measure symptom     management (experience and / or management strategies) during exacerbation episodes in CF     patients. For the development a sequential exploratory two phase mixed-method study will be     applied. In a first step, up to 25 CF patients will be interviewed: approximately 15 CF     patients who experienced at least one episode of exacerbation in the past year and     approximately CF 10 patients who are currently experiencing an exacerbation. The latter group     will be interviewed up to 3 times during and after the antibiotic treatment. The instruments     initial item list will be developed on basis of the interviews. Up to five health     professionals will rate the items' relevance. In a further step, items' clarity and relevance     will be assessed by cognitive debriefing interviews with no more than 10 patients. In the     last step (part III), the instrument's preliminary construct and concurrent validity and     reliability will be tested in a larger sample up to 150 patients experiencing exacerbation.     Patients will be asked to complete the newly developed questionnaires and a set of other     questionnaires at one time point. For part III, ethic approval will be asked at a later date     (2015).   "
62754|NCT02464241|"     The purpose of this study is to investigate which clinical colour vision assessment fits best     for preschool children and school children. The investigators are going to investigate     children with a known colour vision affecting ocular disease, as well as healthy children     without colour vision deficiency. The goal is to compare the usability and validity of three     different clinical tests for colour vision assessment which are already well established in     adults but not yet in children.   "
62755|NCT02464228|"     This Phase II studyis designed to investigate the antitumor activity in terms of objective     response rate (ORR) of tipifarnib in 18 subjects with advanced Peripheral T-Cell Lymphoma     (PTCL). The total number of patients could be extended to 30 pending on the degree of     response observed at an interim analysis. Tipifarnib will be administered until disease     progression then followed approximately every 12 weeks for survival until either death or 12     months after accrual of the last study subject, whichever occurs first.   "
62756|NCT02464215|"     The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2     radical surgery for distal advanced gastric cancer.   "
62757|NCT02464202|"     The aim of this study lies in comparing the outcome of the proposed technique in a large     sample size group to the outcome of the conventional tooth autotransplantation method and to     provide sufficient evidence for improving the long-term success rate of the tooth     autotransplantation procedure.   "
62758|NCT02464189|"     The aim of this study is to assess the knowledge, the attitudes and the practices of parents     of asthmatic children.   "
62759|NCT02464176|"     This study will investigate the ability of systemic dexamethasone to prolong the sensory     block duration for lumbar plexus nerve blockade.   "
62760|NCT02464163|"     The purpose of this study is to investigate the safety and immunogenicity of a recombinant     hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3     dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA     formulation.   "
62761|NCT02464150|"     Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten     containing cookies for 3 days.      Questionnaires and sampling of blood is done before, during and after.   "
62762|NCT02464137|"     single-modality phase I dose escalation toxicity study for first-line curative treatment of     head and neck squamous cell carcinoma.   "
62763|NCT02464124|"     Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic     and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying     severity.      Treatment options include lactulose administered orally or by nasogastric tube or enema,     non-absorbable antibiotics, and protein-restricted diets.      Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by     Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective     study at the 2008 American Association for the Study of Liver Diseases meeting showing     clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.   "
62764|NCT02464111|"     Research goals include evaluating the relative impact of maternal nutritional status versus     recent dietary intake on breast milk micronutrient composition, and evaluating the impact of     a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.   "
62765|NCT02464098|"     Diarrhea is a common problem in the pediatric population. Children with cancer are especially     at increased risk for gastrointestinal infection-related morbidity and mortality due to their     ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in     immunocompromised children is poorly understood. In the past, many or most cases of     gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests     and a presumption that a large proportion of cases are due to treatment, rather than     infections. The availability of new diagnostic tests that detect many gastrointestinal     pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the     causes of infectious diarrhea in children with cancer.      Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of     diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated     PCR.   "
62766|NCT02464085|"     The main goal of this program of research is to advance our understanding of how the severely     damaged brain changes over the first 12-months post stroke. The investigators will determine     'who recovers', 'who does not recover', and 'why'   "
62767|NCT02464072|"     This study evaluates the metabolic and clinical results of two well recognized and accepted     surgical techniques in the management of severe hyperparathyroidism in patients under regular     dialysis treatment.   "
62768|NCT02464059|"     This proposal will evaluate a potential mechanism of increased risk of lung function     impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this     pathway. This study will improve the understanding of factors which can lead to chronic lung     disease. If effective, this application would also provide the justification to study vitamin     D as a therapy to improve lung health.   "
62772|NCT02464007|"     In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose     (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will     not be enrolled until all subjects at the current dose level complete 28 days without DLT.     The optimal dose (OD) will be determined by evaluation of safety in each cohort and disease     response by RECIST 1.1 at 8 weeks. Once the OD is determined, enrollment will continue until     at least 9 subjects total are accrued at the OD. Pharmacokinetics of rSIFN-co will be     conducted for all tested dose levels to characterize dose proportionality.   "
62773|NCT02463994|"     The purpose of this study is to find out whether a brief course of radiation therapy given to     one area affected by the cancer will improve the chances of responding to immuno-therapy in     the form of a medicine called MPDL3280A, an antibody against PD-L1. PD-L1 is expressed on     lung cancers and is known to block the effects of the body's immune system in attacking the     cancer. Blocking this PD-L1 has been shown to improve the body's immune cells to attack and     kill the cancer cells in non-small cell lung cancer. The goal of this study is to see if     prior treatment with radiation will allow improved recognition of the cancer by the body's     immune cells in the presence of MPDL3280A.   "
62774|NCT02463981|"     The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts     pain empathy.   "
62775|NCT02463968|"     Chikungunya is a mosquito-borne viral illness that leads to chronic joint pain in     approximately one half of patients. The mechanisms leading to long term arthritis in humans     has not been well established. There is some evidence from animal studies that activated     macrophages with persistent viral infection may play a role in chronic arthritis however     these mechanisms have not yet been identified in humans. It is hypothesized that activated     macrophages harboring persistent active chikungunya virus are responsible for chronic     arthritis and joint pain in patients. The focus of this proposal is to evaluate synovial     fluid and blood for direct viral persistence and activated macrophages that may clarify the     mechanism of inflammatory injury. The results of this study will be directly applicable to     tailoring trials of therapeutics.   "
62776|NCT02463955|"     EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a     flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.   "
62777|NCT02463942|"     In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high     incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In     clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne     encephalitis antibodies in serum of a patient with compatible clinical presentation and     cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have     cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not     attest Lyme neuroborreliosis.      Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not     fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in     several European countries due to the possibility of double infection. The investigators     hypothesise that such patients do not benefit from antibiotics. Such an approach may appear     safe regarding the possibility of borrelial infection, however it can also be associated with     detrimental consequences such as antibiotic related adverse reactions, negative     epidemiological impact on bacterial resistance, and intravenous catheter related     complications.   "
62778|NCT02463929|"     The purpose of this study is to investigate the effect of diphenhydramine on the prevention     of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators     hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/     agitation.   "
62779|NCT02463916|"     The purpose of this study is too determine the effects of exercise on the gut microbiota and     immunological markers in patients with inflammatory bowel disease and rheumatoid arthritis.   "
62780|NCT02463903|"     The purpose of the present study is to develop, implement and evaluate a stress management     program aiming to improve emotional well-being, health-related quality of life and to reduce     readmission to hospital in patients with chronic heart failure (CHF).      Method: A randomized controlled study design will be employed in which the intervention     consists of Coping Effectiveness Training (CET), a manual-based group intervention based on a     cognitive transactional theory of stress and coping. The purpose of CET is to improve skills     to appraise stress, teach a number of techniques to cope with stress, and to give an     opportunity to interact with other people with similar experiences of living with CHF. The     control group will receive standard health care. The intervention group will receive seven     weekly sessions of CET. Self-assessments of; emotional well-being, depression and anxiety,     illness perception, health-related quality of life, coping strategies and social support will     be performed before the intervention, directly after the intervention, six weeks, six months     and one year after the intervention period as well as measuring readmission to hospital. In     addition, the participants in the intervention group will fill in an anonymous written     evaluation, with closed and open ended questions, directly after the intervention.   "
62781|NCT02463890|"     Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It     does multiply tenfold the occurrence of vascular events, particularly stroke. While     Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to     prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term     adherence to CPAP is a significant problem and search for alternative treatment is essential.      The investigators hypothesize that long-term exercise training would allow to reduce     significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will     compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed     through in a national based non-profit organization (Fédération Française d'éducation     Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program     (NeuroGyV) during nine months against a control group receiving only standard dietetic and     physical activity counseling.   "
62791|NCT02463760|"     The purpose of the study is to investigate imaging findings, which can help us to predict     factors contributing to abdominal aortic aneurysm growth and rupture.   "
62804|NCT02463591|"     The purpose of this study is to investigate whether Prothrombin Complex Concentrate (PCC) is     effective in reversing the anticoagulant effect of Dabigatran, as assessed by two modified     skin-bleeding tests.   "
62782|NCT02463877|"     The purpose of this study is to determine the feasibility of surgical techniques involving     minimal entry into the living body approach for tumor reduction and treatment in which highly     concentrated anticancer drugs are put directly into the abdomen through a tubes (HIPEC), and     to determine if this approach may improve short-term postoperative outcomes, including the     development of complications related to surgery within the first 30 days after surgery.      Participation in this study is entirely voluntary. Approximately 30 subjects will take part     in this single-center study and all will be enrolled at University of California San Diego.   "
62783|NCT02463864|"     This study will help to determine whether frail older medical inpatients will benefit from     targeted exercise sessions performed twice daily while in hospital. Half of the patients will     complete targeted strengthening, balance and endurance exercises and the other half,     stretching and relaxation exercises. The exercise sessions will be assisted and supported by     a senior physiotherapist.   "
62784|NCT02463851|"     The GOLD FORCE trial investigates the differences between treatment with a Contact Force     single-tip catheter against the PVAC GOLD multielectrode catheter in cardiac ablation     procedures in patients with paroxysmal atrial fibrillation.   "
62918|NCT02462096|"     This study is designed to evaluate the safety and technical feasibility of the ReLeaf     Catheter System in the creation of one or more tissue leaflets in the femoral and/or     popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry     criteria.   "
62785|NCT02463838|"     This study will expand and evaluate an existing pilot program to improve care for frequent     users of acute emergency and inpatient services by providing care coordination and management     for eligible San Francisco Health Plan members. SF Health Plan's Community-Based Care     Management pilot program (Program) known as CareSupport serves vulnerable SF Health Plan     members who are high utilizers of hospital inpatient and emergency departments and at     extremely high risk for mortality and morbidity due to factors such as housing instability,     mental illness, and addiction. Care managers, called community coordinators, are trained     bachelor-level social workers or outreach workers and each have a panel of 30-35 members who     they directly engage in the community where the members tend to live or congregate (shelters,     bus stops, coffee shops, community agencies, and by cell phone) to help them improve their     health and navigate through the health care and social services systems. The number of San     Francisco Health Plan members who would be eligible for Care Support services far outstrips     the capacity the San Francisco Health Plan to provide these additional services, and the     investigators will thus evaluate the intervention using a randomized trial design.   "
62786|NCT02463825|"     Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease that results in rapid decline     in normal muscle function and tone leading to difficulties with mobility, eating, drinking,     breathing, sleeping, and communicating. The disease is progressive and no cure currently     exists. Most people diagnosed with ALS succumb within 3 to 5 years. The only approved     treatment to slow the progression of ALS is called Rilutek® (riluzole) which has only a     modest effect and has been shown to increase survival by a few months.      Muscular dysfunction present in people with ALS is caused by nerve breakdown and a     dysfunction in the communication between the muscles and the nerves. The area where these     communications occur is called the neuromuscular junction. Some recent studies have focused     on using different medications to enhance communication at the neuromuscular junction with     the goal of improving muscle function as a result. This approach is unproven but may help to     slow the progression of the disease.      Pimozide is a medication that has been demonstrated to enhance communication at the     neuromuscular junction in fish and mice. This study will look at whether Pimozide may help to     slow the progression of ALS and how much medication needs to be taken to have an effect.   "
62787|NCT02463812|"     Surgery puts a lot of stress on the body, and during recovery from surgery, the body uses a     lot of energy to help with healing and getting stronger. Often, sugars are given before     surgery to help give the body an energy boost. Lipid solutions can also be used as an energy     source and are commonly used as supplements in patients needing long-term nutrition from an     intravenous route (e.g., total parenteral nutrition) when they can not eat by mouth for a     medical reason. Intralipid, a solution of lipid molecules from soybeans and eggs, is commonly     used for patients who need nutrition and energy supplements. The investigators wish to test     whether giving Intralipid immediately after surgery can improve recovery from major surgery.   "
62788|NCT02463799|"     This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating     castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous     cellular immunotherapy designed to stimulate an immune response against prostate cancer. It     has been suggested that the immune response may be strengthened by radiation therapy.     Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune     response and anti-tumor effect against prostate cancer.   "
62789|NCT02463786|"     Heart failure (HF) remains to have a poor outcome. Even though recent advances in HF led to a     reduction of morbidity and mortality, improvement in outcome is much less than expected based     on large randomized trials. Various reasons may be responsible, such as complexity of disease     and comorbidities, inadequate diagnosis and inappropriate treatment. So far, little attention     has been paid on patients seen in primary care. Also, HF care mainly focuses on the     individual patient-doctor relationship. However, the increasing complexity prevents     individual physicians from covering all aspects of care. Consequently, multiple stakeholders     are involved, including both general practitioners and specialists. Still, the relative role,     the interaction between them and the processes included are hardly defined. These aspects may     not only be relevant for patient care, but also for the setup of health care systems. Whereas     multidisciplinary team should resemble a seamless system across primary and hospital care,     there is a scarcity of research considering how these disease management programs perform, in     what form they should be offered, and what care and support patients and caregivers would     benefit most.The INTERACT-in HF (Improving kNowldege Transfer to Efficaciously RAise level of     Contemporary Treatment in Heart Failure) study is set up to determine and assess relevant     factors of the quality of HF care. The study evaluates processes of HF care, role of relevant     care givers and interactions between them. It collects data from individual patients to     assess characteristics and management of contemporary HF patients. This is performed in     different countries (the Netherlands, Belgium and Germany) to analyze decision making with     respect to diagnostics and treatment.Cross-sectional mixed-methods are used. Patients and     their caregivers are interviewed. The patient is the central starting point. Then, the     treating GP, cardiologist and HF nurse are interviewed. In parallel, retrospective data based     on records from these patients are reviewed to verify data from interviews and to determine     characteristics of them. Retrospective data of additional patients are collected to complete     the picture of the current situation. These data will be used to define bottlenecks that     prevent best clinical practice to be used in daily care at all levels, comparing practice in     different countries.Thus, the proposal aims to better understand HF care, which will lead to     a better care and finally to improved outcome.   "
62790|NCT02463773|"     This is a proof of concept study where we aim to study the correlation between the use of a     simple bedside ultrasound measurement of diaphragmatic muscle excursion with established (but     time consuming) measurements made to optimize an important setting on the mechanical     ventilator (positive end expiratory pressure or PEEP) in intubated adults with acute     respiratory distress syndrome (ARDS) in the medical ICU.   "
62792|NCT02463747|"     Neutropenic fever is a life threatening condition that is not rare in patients suffering from     hematologic disorders, and of paramount importance to early and effective treatment. In this     trial we concentrate on hospitalized patients with hematologic malignancies who develop     neutropenic fever.      In recent years, several studies were conducted to examine possible changes in the     conventional empirical treatment, assuming that administration of the antibiotics in a     prolonged infusion would allow for a greater fT > MIC that will lead to a better efficacy.      These studies were carried out in different populations and there is only limited information     about the importance of continuous infusion therapy in patients with hematologic diseases     with neutropenic fever.      Research goals: The main goal is to compare between two groups of hematologic patients with     neutropenic fever, The first group will receive antibiotic therapy in extended infusion, and     the second (control) group will receive the treatment in a fixed time.   "
62919|NCT02462083|"     The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.   "
62920|NCT02462070|"     The objective of the study is to evaluate the safety and efficacy of a topical lotion.   "
62793|NCT02463734|"     The purpose of this research is to develop the DQoL-OC, a unique questionnaire to evaluate     the quality of life of people aged 60 or above providing care for a family member with     Alzheimer's disease or other related dementia at home in the UK.      This questionnaire is aimed at allowing researchers, health and social professionals, as well     as the older family carers themselves, to quantify the impact caring in different aspects     life, for the purposes of economic evaluation or implementation and evaluation of     interventions. The results from this study will also help us to understand better the aspects     that affect carers' quality of life and well-being, which may guide future policies and the     support provided to older family carers in the future.      The DQoL-OC is being developed in two parts. The first part is now completed and was carried     out through focus groups with older family carers for discussions about important aspects     related to their quality of life and well-being in order to create the items of the new     questionnaire. Its preliminary version contains 100 questions about the practical aspects of     care and caregiving, carers' feelings and concerns and satisfaction with life and with the     caring role.      The second part of the DQoL-OC development is currently being carried out and aims to     evaluate its validity and reliability for use with older family carers and to reduce it into     a smaller number of items. About 300 older family carers are invited to answer individually     the DQoL-OC and other similar questionnaires for these purposes. About 25 participants taking     part in this study are invited to answer the same questions with an interval of two weeks in     order to allow us to compare the results and its stability over this period of time.   "
62794|NCT02463721|"     Several studies have pointed out changes in the epidemiology of the causative bacteria in SBP     and bacterascites and in their susceptibility to antibiotics. In particular, the development     of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum     beta-lactamases in Escherichia coli. The potential emergence of enterococci,     methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin     prophylaxis, is also a cause of concern since they may be associated with a higher risk of     therapeutic failure.      The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance     rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime),     ciprofloxacin, and ofloxacin increased dramatically   "
62795|NCT02463708|"     This project will conduct a retrospective clinical database review and a one-time research     interview to evaluate outcomes among a sub-set of caregivers (CGs) who were enrolled in the     Behavioral Health Laboratory (BHL) Caregiver Outreach and Telehealth Education Program     (COTP). The investigators will recruit CGs whose Care Recipients (CR) met criteria for     clinically significant cognitive impairment and/or dementia and who received care management     services through the COTP.   "
62796|NCT02463695|"     The pathophysiology of vertigo is complex and usually requires specialist involvement. During     the diagnostic process, patients commonly undergo tests which assess the integrity of the     gaze and posture stabilisation mechanisms involving the inner ear (vestibular system), the     visual systems and the subconscious neural pathways that interconnect them. Whilst these     tests are useful they fail to provide information concerning the neural connections to the     cortex and therefore neglect the perceptual aspects of disequilibrium.      At present the possibility of routine examination of these higher projections remains elusive     as no practical alternatives to the expensive functional magnetic resonance imaging systems     exist. However, recently a novel method of recording cortical vestibular evoked potentials     (CVEPs) has been described.      CVEPs utilise an existing method used to interrogate cortical projections from the auditory     system in which sound waves stimulate the inner ear and the resulting electrical responses     from the brain are recorded. The recent breakthrough is in the realisation that these     responses also contain information from the balance organs and therefore are a direct measure     of cortical processing of the vestibular inputs.      Current evidence shows that CVEPs are present in the normal population and absent in patients     with no vestibular function. The primary aim for this study is to extend the patient cohort     to include those who have a vestibular injury but retain residual function. Patients going     through standard testing will have also have CVEPs on both ears providing seminal information     into the effect of injury to the peripheral vestibular system on the cortical pathways.     Furthermore, by following the cohort through their complete management pathway it will be     possible to ascertain if the CVEP can be used to predict rehabilitation outcome success.   "
62797|NCT02463682|"     This is a feasibility study of an artificial pancreas (AP) system with our previously     validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov:     NCT01929798) integrated into the Diabetes Assistant (DiAs) system.   "
62798|NCT02463669|"     The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS)     is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr     Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with     sore throat to the Emergency Department (ED).   "
62799|NCT02463656|"     Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by     mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb     and eye abnormalities. Short stature and underweight have been noted in the majority of these     patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect     that pituitary deficiencies may contribute to poor linear growth. This study will examine the     nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth     stunting and low weight that is observed in FDH. The investigators will utilize standard     clinical tools including a bone age xray, glucagon stimulation test to evaluate growth     hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal     markers, food diaries, symptom diaries, and growth charts.   "
62800|NCT02463643|"     The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40     mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A     to D as defined by the LA classification grading system.   "
62805|NCT02463578|"     Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil     cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine     recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal     vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks     later).   "
62806|NCT02463565|"     Food provision and consumption were assessed for all hospitalized patients over a 24h-period     survey. This study is a part of a control quality programme and is performed every 4 years     since 1999.   "
62807|NCT02463552|"     This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory     Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.   "
62808|NCT02463539|"     Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil     cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through     pneumococcal immunization.   "
62809|NCT02463526|"     Participants will be initially assessed for their suitability for inclusion in the study and     will undergo a physical screening of the affected shoulder and cervical spine by an     experienced physiotherapist. After, participants will be attended 72 hours after data     recording of the baseline measures (range of motion with a goniometer, pressure pain     threshold with a algometer, and peak force with a dynamometer) for four sessions per week     with 24 hours of interval between sessions. At each experimental week session, each     participant will receive one of the two treatment conditions (MWM or sham) and then will     repeats the assessment. In the following week, there will be a crossover condition of each     individual and 24 hours after the last treatment session, the examiner will do the last     assessment.   "
62810|NCT02463513|"     Approximately 10% of the world's population have a particular genetic makeup (known as the TT     genotype) that may increase their risk of having higher blood pressure. Previous work     conducted by the investigators research group at the University of Ulster, in collaboration     with clinical colleagues from across Northern Ireland, in premature CVD patients and     hypertensive adults generally has demonstrated that a dietary level of riboflavin (1.6mg/d)     decreases blood pressure, specifically in those with the TT genotype. To date, the blood     pressure lowering effects of higher doses of riboflavin in individuals with the TT genotype     is not known. The aim of this study is to investigate whether supplementation with riboflavin     at a low dose supplemental level (10mg/d) can decrease blood pressure more effectively than     the dietary level (1.6mg/d) by optimising riboflavin status and normalising MTHFR activity.     This aim will be achieved by conducting a double-blind placebo-controlled intervention study     over a 16 week period.      Participants will be recruited from cohorts screened for the methylenetetrahydrofolate     reductase (MTHFR) C677T polymorphism. Those identified with the TT genotype (homozygous for     the polymorphism) that wish to participate in this research will be asked to attend a     baseline and week-16 appointment and will be asked to take a daily riboflavin (1.6 or 10mg/d)     or placebo capsule for the duration of the study. At each appointment a blood sample will be     taken and blood pressure, height, weight and waist circumference will be measured. If the     results of this study show that intervention with a higher dose of riboflavin can lower blood     pressure more effectively in individuals with the TT genotype this will have important     implications for those responsible for the management of blood pressure. The findings will be     of particular relevance in populations with a higher prevalence of the polymorphism.   "
62811|NCT02463500|"     This will be a continuing, prospective study of diabetic foot ulcers and infections, risk     factors and clinical outcomes and a limited data set conducted by the investigator through     the establishment of a data and tissue repository in the uT Southwestern Department of     Plastic Surgery. in addition, subjects consented for this research will be asked about     inclusion in a recruitment database to be used in the recruitment of subjects for future     research on diabetic foot complications.      about 250 patients are seen for diabetic foot ulcers and infections each year.   "
62812|NCT02463487|"     The investigators plan a randomized clinical trial of 150 patients with infected     diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of     negative pressure wound therapy with continuous irrigation and negative pressure wound     therapy without irrigation.   "
62813|NCT02463474|"     This research study will test whether a series of video clips with breast cancer information     improves knowledge of breast cancer, breast cancer treatment and living with breast cancer.     Questionnaires will be completed to learn if the videos are helpful and pleasant to watch.   "
62814|NCT02463461|"     The primary objective of the proposed study is to investigate the agreement levels of modern     and well-established actigraphy devices against PSG in healthy as well as patient populations     for multiple sleep parameters across two study sites (Qatar and New York City).   "
62815|NCT02463448|"     This is a prospective, open-label, Phase 1, single center study evaluating the safety and     efficacy of Autologous Muscle Derived Cells as a treatment for chronic Underactive Bladder.   "
62816|NCT02463435|"     Obesity is a worldwide epidemic with increasing prevalence, specially severe obesity (Body     Mass Index (BMI) ≥ 35 kg/m2). It is a multifactorial disease that involves genetic and     environmental factors that lead to increased mortality from cardiovascular disease, diabetes,     cancer, among others and impairs life quality. Most research on severe obesity focuses on     surgical alternatives and their results, thus this clinical trial aims to evaluate the effect     of a non-pharmacological approach based on nutritional intervention and supplementation with     a functional food, the olive oil. It will analyze the effectiveness of interventions on:     weight loss, improvements on body composition and inflammatory profile (TNF-alfa,     interleucins 1, 6 and 10, adiponectin), insulin resistance and serum lipids control, changing     eating habits and physical activity practice, modification on bone mineral density and     sarcopenia, and reduction of cardiovascular risk and other diseases. Also, it will be     investigated the influence of polymorphisms (Pro12Ala of PPAR-γ gene, -174G>C of IL6 gene e     Trp64Arg of ADRB3 gene) on nutritional intervention effectiveness with and without olive oil.     This research looks for improving severely obese patient's care and contributing to effective     results by reducing costs and risk treatment. The investigators believe that this     informations will contribute significantly to the scientific field, expanding the knowledge     about severe obesity.   "
62837|NCT02463149|"     This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based     experiential culinary and nutrition literacy curriculum for middle-school students. The     primary study hypothesis was that students assigned to YCA would demonstrate greater     improvement in F/V and whole grain consumption compared to students in the control group.     Eight classrooms in eight public K-8 schools participated in the project. Classrooms were     assigned to intervention or control condition in a non-randomized manner. YCA was delivered     by project staff to all of the students in the four intervention classrooms. Students     completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum     completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum     cohort).   "
62865|NCT02462785|"     Helping individuals with diabetes to control their blood sugars through self-management is an     important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and     management. There is very little research examining CHO counting education with adolescents     who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate a newly     developed internet-based teaching module of CHO counting for adolescents, ages 12-17 years,     with T1DM and who do not regularly CHO count and require instruction. A secondary aim is to     assess feasibility for a future, larger-scale clinical trail. An effective web-based CHO     counting tutorial could be used to strengthen current diabetes education programs and may     serve as a basis for developing other teaching modules. Advantages of web-based teaching     include convenience, increased accessibility, and the ability to review and reinforce     teaching concepts through repetition. It may also encourage adolescents to take the     initiative for their own diabetes care, beginning with a self-directed, active learning     experience.   "
62817|NCT02463422|"     According to a recent report from the Centers for Disease Control, most children with ASD do     not receive a diagnosis and begin receiving treatment until well after their 4th birthday,     which is unfortunate given that many connections between brain cells have already been     established by that age. This program will test a model called Get S.E.T. Early (S=Screen,     E=Evaluate, T=Treat) in both San Diego and Phoenix, designed to detect, evaluate, and treat     ASD within the first 2 years of life. In this proposal 7,500 toddlers from the general     population will be screened in San Diego and Phoenix (total 15,000) using the CSBS IT     Checklist (Wetherby & Prizant, 2002) at well baby check-ups using a triple screen approach     wherein toddlers are screened at three ages starting at 12 months. Investigators predict that     providing screening tools with clear cut-off scores and guidelines for automatic referral for     both evaluation and treatment will result in dramatically lowering mean age of detection in     Phoenix from 4-5 years down to 1-2 years. Investigators also predict that using repeat     screening at 12, 18, & 24 months in combination with automatic referral options via     technology (i-Pads) will result in an increase in the number of ASD toddlers detected by 24     months relative to a single time point screen using traditional paper screens.   "
62818|NCT02463409|"     This study will test an investigational drug, theophylline, in children with     pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt     Clinical Research Center.   "
62819|NCT02463396|"     The primary aim of this study is to investigate clinical effectiveness of mindfulness     training versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity     Disorder (ADHD). The secondary aim is to assess whether mindfulness training is     cost-effective compared to TAU in adults with ADHD from a societal perspective.   "
62820|NCT02463383|"     Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2     (PPARG) polymorphism, were given the following treatments in a random order with a 5w     wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed     after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were     measured before and at three timepoints after alcohol intake. It is hypothesized that the     acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is     modulated by ibuprofen and by PPARG genotype.   "
62821|NCT02463370|"     Submucosal resection of the nasal septum (SMR) could be performed under local anesthetic     infiltration performed through ten injections in addition to general anesthesia which was     associated with less postoperative pain and shorter hospital stay.      However, the local infiltration technique is time-consuming and requires a large number of     facial injections. This gave rise to the idea of reducing the number of injections while     retaining the effectiveness of the local anesthetic technique.      Decreasing the number of injections could be achieved by blocking the superior maxillary     nerve (V2) and the infra-orbital nerve since it would result in anesthetizing the surgical     area as well after induction of general anesthesia.      The purpose of this prospective double-blind clinical trial was to compare the effectiveness     of four versus ten local anesthetic injections in terms of postoperative pain relief. The     secondary objective was to compare patients' and surgeons' satisfaction between the two     techniques.   "
62822|NCT02463357|"     Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of     non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric     pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS.     Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and     difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance     and endurance exercise capacity are impaired. Therefore, the goal of this research is to     identify effective pharmacological agents that will help reduce the symptoms of AMS and     improve physical and cognitive performance at high altitude.      The investigators will study the efficacy of the dietary supplement, quercetin, the drugs     nifedipine (extended release) and methazolamide taken together, the drug metformin, and the     drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at     high altitudes.   "
62823|NCT02463344|"     The purpose of his study is to evaluate the long term safety and tolerability of MA09-hRPE     cellular therapy in patients with advanced dry Age-Related Macular Degeneration (AMD) from     one to five years following the surgical procedure to implant the MA09-hRPE cells.   "
62824|NCT02463331|"     The gold-standard treatment of Autoimmune hepatitis (AIH), with prednisone alone or in     conjunction with azathioprine can reach resolution of the disease in 70-80% of the cases in     US. However, in Brazil the response to these treatments seems to be worse, approximately 35%     in five years. Because of the side effects of the gold-standard treatment and the need for an     alternative option for the no responsive patients, news drugs must be evaluated for this     proposal. Chloroquine diphosphate is an antimalarial drug that has been used for the     treatment of rheumatological diseases for at the least five decades. Chloroquine was used as     a single drug for up to two years for the maintenance of AIH remission in an open study.     There was a 6.49 greater chance of relapse in the historical controls when compared with     patients treated with chloroquine (72.2% x 23.5%; p = 0.031). The aim of this study was to     investigate whether chloroquine in conjunction with prednisone can be used as an alternative     treatment of AIH in a randomized study, and to evaluate its side effects.   "
62825|NCT02463318|"     The purpose of this study is to investigate the gene expression and activity of SIRT1, and     forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple     sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction     between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy     subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene     expression and activity of above-mentioned genes in peripheral blood mononuclear cells of     healthy subjects-treated with H2O2.   "
62866|NCT02462772|"     The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA)     injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in     KwaZulu-Natal, South Africa.   "
62953|NCT02461641|"     This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and     complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity     compared to standard care alone.   "
85144|NCT02171559|"     To investigate the relative bioavailability and the pharmacodynamics of dabigatran after     switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone   "
62827|NCT02463292|"     This study aims to evaluate the psychosocial situation of adult congenital heart disease     (CHD) patients in terms of health-related quality of life, mental health, academic     achievement, and employment status. By assessing a wide variety of medical (e.g., disease     severity) and psychosocial (e.g., life events, coping strategies, personality) risk factors     it will be possible to better understand the variables that influence psychosocial outcome of     young adults with congenital heart disease. This will further improve the understanding of     the lifelong consequences of a congenital heart malformation. Factors that proof to be     predictors of favorable outcome represent a resource of resilience and therefore should play     an important role in the care of CHD patients. By implementing those results in patient care     the investigators aim to achieve an improved psychosocial outcome among adult congenital     heart disease (ACHD).      Hypothesis 1: It is expected that perceived health status, health-related quality of life and     psychological adjustment will not differ between the patient and the control group. However,     academic achievement and employment status are expected to be poorer in young adults with     congenital heart disease compared to healthy controls.      Hypothesis 2: It is assumed that parental socioeconomic status, problems in emotional     regulation and impaired social support will be related to a negative psychosocial outcome and     health-related quality of life. Moreover, the investigators hypothesize that disease severity     is associated with academic outcome and employment status.   "
62828|NCT02463279|"     The goal of this study is to evaluate basic usability and confirm expected safety and     effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid     sinus ostia in patients with chronic rhinosinusitis.   "
62829|NCT02463266|"     The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is a     telephone-based clinical service designed to help identify and manage behavioral health     issues among PACE/PACENET enrollees. The purpose of the current project is to a) explore     moderators of treatment response among beneficiaries in the SUSTAIN Clinical Program and b)     to evaluate the sustained clinical effects of the program.   "
62830|NCT02463253|"     This is a single-center, prospective, non-randomized, observational study to evaluate     specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft     nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney     tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely     monitored over one year after enrollment.   "
62831|NCT02463227|"     The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK),     and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was     well-controlled with HIV medicines. The study examined whether VRC01 controlled or delayed     the return of HIV viremia when the participants' HIV medicines were briefly stopped during     the study.   "
62832|NCT02463214|"     This study involves sampling bone marrow transplant patients, hospital workers and the     patient room for microbes using swabs and other techniques. We send these samples to the     laboratory, where they will use state-of-the art technology to identify and relate the     microbes to each other. This study also involves putting copper, nickel, or titanium into     some hospital rooms, and seeing whether these metals influences the growth of microbes. Some     equipment in the hospital room, such as faucets and soap dispensers will be replaced by     sensor-based (e.g. touchless) controls.   "
62833|NCT02463201|"     The prevalence of childhood obesity has increased at an alarming rate over the last decades,     both globally and in Denmark. There are a number of serious sequelae related to obesity, such     as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a     risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated     with cardiovascular complications, neurocognitive problems and reduced quality of life. The     correlation between obesity and OSA is still poorly understood. Early detection and     intervention is of great importance as the health consequences related to OSA as well as     obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with     OSA. However, only around 25% of obese children benefit from this treatment compared to     around 75% of normal-weight children suggesting that there might be other structural factors     predisposing to OSA in obese children.      In this study the investigators aim to clarify the impact of obesity in the development of     OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is     to assess the effect of weight loss on OSA.   "
62834|NCT02463188|"     The goal is to adapt and refine an innovative, developmentally-appropriate universal health     promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while     engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness     of the program for diverse school settings.   "
62835|NCT02463175|"     Surgery for scoliosis correction, the abnormal curvature of the spine, is a major procedure     often undertaken in adolescents. In adult anesthesia, there is a large volume of literature     debating how to optimize fluids administered during surgery, as both too much fluid and too     little fluid are associated with worse outcomes. The investigators will compare fluid     administration based on the measured amount of blood pumped by the heart during each heart     beat (goal-directed therapy), against standard anesthetic management. The main outcomes are     a) post-surgical kidney dysfunction, b) prevalence of intraoperative hypotension, c) volumes     of administered fluids, and d) length of hospitalization.   "
62836|NCT02463162|"     The Canadian population is aging and more people are living with advanced chronic diseases.     At the end of life (EOL), the use of invasive medical treatments in hospitals is increasing     and associated with worse outcomes. Advance Care Planning (ACP) may help improve care at EOL     to be the way patients want it. ACP is a process where people think about the various options     related to future health care decisions and they may communicate with a verbal or written     plan of what care they would want in the EOL. Also, they may nominate a substitute decision     maker if they become unable to speak for themselves. A national poll found that few Canadians     have thought about or made an ACP.      Alberta Health Services has developed two videos (Videos) to help with decision making about     ACP and goals of care designations(GCD). GCD are medical orders of care that (a) serve as a     communication tool for HCP to assist in rapid decision making; and (b) guide HCP and patients     regarding the general intent and locations of care, and interventions that are to be     provided. This study will compare ACP behaviours and GCD preferences for participants who     have seen the Videos with those who have not and measure the change in those behaviours and     preferences at 1, 2 and 3 months. It will also look at the impact of the Videos on health     care costs and service use. Participants from five patient groups (metastatic lung cancer,     colorectal cancer, gynecological cancer, renal failure, and heart failure) were selected as     representative of where ACP should ideally be occurring, and where data on ACP implementation     is presently most lacking, and as venues in which this research is most feasible. Collecting     information about patients' ACP and GCD preferences may help improve AHS decision making     tools and more generally help healthcare leaders plan ways to better engage patients in the     ACP process.   "
62838|NCT02463136|"     Adolescents are particularly vulnerable to psychological problems, partly because of dramatic     changes in the brain, along with changes in social interactions patterns as they move from     childhood towards adulthood. One of the most common problems is anxiety, which affects up to     1 in 4 adolescents. Moreover, paediatric anxiety predicts lifelong persistent mental health     problems, which are estimated to cost the UK taxpayer £8.6 billion annually. Young people     with anxiety experience intense fears and worries, leading to problems with friendships, poor     school performance, and long-term mental health difficulties. Research investigating how and     why some young people develop anxiety is therefore critically needed so that strategies for     early intervention can be developed.      This research will test the hypothesis that using a novel training intervention, - which     teaches participants to change the way that their brain responds to emotional stimuli - will     allow the investigators to influence response strategies while they are being established and     possibly reduce the risk for anxiety in the long run. To achieve this, the investigators will     test 50 adolescent females (aged 14-17 years) varying in anxiety levels to investigate     whether brain responses in emotion regulation regions can be up/down regulated using     fMRI-based neurofeedback.The rationale behind this research approach is that successful     changes in brain response may then provide the participant with an additional, 'bodily'     feeling of how respond to an emotional stimulus in real life situations, thereby paving the     path towards the development of effective, age-appropriate intervention approaches.   "
62840|NCT02463110|"     Primary purpose:      To evaluate the evolution in time of the antiaggregant platelet effect of sertraline (SSRI)     compared to placebo in depressive patients with ACS (Acute Coronary Syndrome) and treated as     recommended by a double antiplatelet therapy, aspirin and clopidogrel.      Hypothesis:      The benefits of SSRIs observed in depressive patients with ACS are related to an antiplatelet     effect.   "
62841|NCT02463097|"     This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects     with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate     that the closed loop algorithm that is built into the 670G insulin pump is safe as part of     the overall system.   "
62842|NCT02463084|"     This study compares the effects of a one-month diet high in saturated fat (SF), glycemic     index (GI), and salt (Na+) to a diet low in these nutritional parameters on memory and other     cognitive functions, on MRI measures of brain structure, function, and perfusion, as well as     on blood and cerebrospinal fluid levels of amyloid-beta (Aβ), insulin, lipids (total     cholesterol, HDL, LDL, oxidized LDL, and triglycerides), cytokines, apolipoprotein E (ApoE),     apolipoprotein J, cortisol, soluble low density lipoprotein receptor-related protein (sLRP),     and glucose in middle-aged adults (45-65 years of age) with normal cognition or mild     cognitive impairment.   "
62843|NCT02463071|"     This study is a randomised, double-blind phase III long-term study to evaluate efficacy and     safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients     with hyperlipidemia accompanied by hypertriglyceridemia .   "
62844|NCT02463058|"     Israel ministry of defense is examining a new protective undergarment of GORE company     (chempark fabric) for the police forces. The goal of this research is to perform a     comparative experiment in order to evaluate the physiological strain induced by a BC     protective undergarment under exercise-heat stress conditions.   "
62845|NCT02463045|"     This study evaluates the safety and tolerability of TOP1288 rectal single and multiple     ascending doses in healthy subjects and multiple doses in subjects with ulcerative colitis.   "
62846|NCT02463032|"     The purpose of this study is to determine if GTx-024 at different dosages (9 mg or 18 mg) is     effective and safe in the treatment of patients with metastatic or locally advanced ER+ and     AR+ breast cancer in postmenopausal women.   "
62847|NCT02463019|"     This open-label study is an roll-over extension of a randomized trial Efficacy of Tenofovir     Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight     Aminotransferase Elevation (NCT01522625).      After finishing the 3-year therapeutic trial, all patients receive open-label TDF for another     3 years. All patients undergo liver biopsy to evaluate the stage of fibrosis after the 3-year     open-label therapy. During the 3-year period, patients were followed up every 12 weeks for     the biochemical, serological, virological parameters, and adverse reactions.      The primary outcome is the progression of liver fibrosis. Safety issues such as change of     renal function and bone mineral density are 2nd outcomes.   "
62848|NCT02463006|"     Till date, no study has been reported in the literature where porous bioactive glass was used     for the management of periodontal osseous defects. In this context, the present study is     designed to assess the efficacy of the porous variant of bioactive glass and compare with     that of nonporous variant using cone beam computed tomography.   "
62849|NCT02462993|"     Background: Aloe vera is considered to be the most promising and high-ranking agent as an     all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to     evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as     an adjunct to scaling and root planing in the treatment of chronic periodontitis.   "
62850|NCT02462980|"     Use of the AcQMap High Resolution Mapping and Imaging System to map persistent atrial     fibrillation to identify potential mechanistic targets for ablation.   "
62864|NCT02462798|"     Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major     source of iron, but much of this is not bioavailability due to it being bound by the high     amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can     release iron and increase its bioavailability. In a human cell model of iron uptake,     sourdough fermentation, which included activation of phytase, the enzyme that breaks down     phyate, led to improved iron bioavailability. This clinical trial will attempt to demonstrate     that this concept also works in humans   "
62892|NCT02462434|"     This study evaluates maternal psychological distress and the impact of early palliative care     team consultation on maternal anxiety and depression symptoms, coping, and quality of     life/family functioning in the care of neonates born with single ventricle physiology. Half     of the participants will receive early palliative care team consultation, while the other     half will receive usual care (no or late palliative care intervention). The investigators     hypothesize maternal stress, anxiety, and depression will be lower in the palliative care     intervention group compared with the control group, and maternal coping mechanisms and     perceived quality of life and family functioning will improve at the pre-discharge     assessment.   "
62851|NCT02462967|"     Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo     controlled, double blind study. This study will enroll subjects with portal hypertension     (HVPG greater than or equal to 6 mm Hg) who also have a liver biopsy with cirrhosis (Ishak     stage 5 or 6), presumably due to NASH, excluding subjects with medium and large varices and     those with decompensated cirrhosis.      Subjects with portal hypertension and cirrhosis will be randomly assigned (1:1:1 ratio) to     receive 1 of 3 treatment assignments including placebo, GR MD 02 in a dose of 2 mg/kg lean     body mass, or GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over     a 52 week period for a total of 26 intravenous infusions. The primary endpoint analysis is     the baseline adjusted change in HVPG at 1 year (53 55 weeks) in subjects treated with placebo     as compared to subjects treated with GR MD 02 (2 mg/kg/week or 8 mg/kg/week).      An esophagogastroduodenoscopy (EGD) with evaluation for varices, HVPG, and liver biopsy will     be performed before the first infusion and after the final 26th dose of IMP. Additionally,     subjects will undergo a FibroScan (if available) prior to the first infusion, at Infusion     Visit 13, and 14 to 28 days following final 26th infusion, an MBT (if available) will be     performed at screening, at Infusion Visit 13, and 14 to 28 days after the final infusion, and     blood will be collected for assessment of biomarkers.      All subjects are to attend 2 postdose visits: the first will occur 14 to 28 days after the     final dose administration and a second will occur 14 days following the first postdose visit.      Subjects will be offered enrollment into a subsequent separate study, an open label extension     study, if there is adequate tolerability and no safety issues or signs of clinical     progression that would recommend discontinuation.      Subjects who do not enroll in the open label extension study will be contacted via telephone     every 6 months for 2 years and annually thereafter for a total of 4 years.   "
62852|NCT02462954|"     The purpose of this study is to evaluate the safety of ContraGel versus the     hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during     two 7-day periods of daily use, the first without intercourse and the second with     intercourse.   "
62853|NCT02462941|"     Heart transplants save the lives of nearly 500 children in heart failure per year. Columbia     is one of the largest pediatric heart transplant centers in the world, averaging 25     transplants per year, and providing ongoing care to nearly 250 children with transplanted     hearts. After transplant, children are at increased risk to develop sudden onset of     abnormally fast heart rates. This research project will study adenosine, a medication that is     routinely used to slow fast heart rates in non-transplanted children (i.e. normal hearts),     and its effects on the transplanted heart. Adenosine is often not used in patients with     transplanted hearts because, based on prior limited research in adult patients, the standard     adult dose may have a longer medication effect, producing a slower heart rate for an     undesirable period of time. However, the current alternatives to adenosine treatment are     either inappropriate for the pediatric age range, or have increased risk of unwanted side     effects. This research project will answer two questions: is adenosine safe to give a child     who has had a heart transplant, and will it be effective in treating the fast heart rate?      All pediatric heart transplant patients undergo regular heart testing, known as a cardiac     catheterization, one or more times per year. Three days before testing, participants will be     asked to stop a regular medication, dipyridamole, because it slows the breakdown of adenosine     in the body, and may increase its effects. (Of note, all patients that are on dipyridamole     are also on aspirin, which gives a second line of heart protection, and will not be stopped.)     After regular cardiac catheterization, all patients will already have intravenous (IV) access     to give medication. Also, this setting allows the opportunity to have a back-up pacing     catheter in the heart, ensuring that there will not be a longer than desired effect from the     medication. Adenosine will be given per a low-dose protocol until either the medication     effect is seen or the maximum dose is reached. There will be no difference in procedure     recovery period time, and patients will resume regular home medications after finishing the     test. As Columbia is one of largest pediatric heart transplant centers in the world, studying     the effects of adenosine at low doses will benefit the investigators population greatly,     either to find a new recommended medication dose, or to provide evidence that this medication     is truly inadvisable for the investigators patients.      The initial study was completed with all 80 patients enrolled and tested. Subsequent testing     is now ongoing on patients in whom dipyridamole was stopped prior to their initial testing     with a repeat study without discontinuing the dipyridamole. We anticipate re-testing about 30     of the 80 patients.   "
62854|NCT02462928|"     This is a safety and efficacy study of abicipar pegol in patients with neovascular     age-related macular degeneration.   "
62855|NCT02462915|"     In our study, we compared the ventilation performance of i-gel to the endotracheal tube     during laparoscopic surgery.      The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we     wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal     volume, peak airway pressure and mean airway pressure.      In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during     volume controlled ventilation in laparoscopic surgeries.   "
62856|NCT02462902|"     300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and     sepsis induced hypotension to the intensive care unit, the emergency department and the step     down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion     criteria.      This study will be a single centre prospective randomized comparative trial. Patients will be     randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution     (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over     15 minutes).   "
62857|NCT02462889|"     This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept     injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related     macular degeneration (AMD) in high-risk subjects.   "
62858|NCT02462876|"     This study will assess the long term safety and performance of the GORE® VIABAHN®     Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.   "
62859|NCT02462863|"     The purpose of this research study is to determine if the nutrients arginine and fish oil     will reverse or improve diabetes and to find out what additional good or bad effects a     combination of arginine and fish oil may have. Both arginine and fish oil are common     nutrients taken by normal people on a frequent basis. However, they have not been used in     combination in the proposed doses to reverse diabetes once it is established. This study has     been approved by the Food and Drug Administration (FDA investigational new drug [IND] 12191).   "
62860|NCT02462850|"     The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108     (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to     severe acute pain (flare) associated with osteoarthritis of the knee or hip under actual     conditions of use.   "
62861|NCT02462837|"     The objective of this pilot study is to assess whether Myrbetriq™ will improve post-operative     ureteral pain and discomfort, reduce bladder storage symptoms and increase quality of life     following ureteral stenting.   "
62862|NCT02462824|"     The purpose of this study is to determine the effects of a home-based exercise intervention     on walking ability in people with peripheral artery disease. In 200 patients with peripheral     artery disease (PAD), the investigators are conducting a randomized controlled trial to     determine whether a patient-centered home-based exercise program improves walking ability,     physical activity, mobility, pain, and social functioning, compared to a usual care group.   "
62863|NCT02462811|"     The objectives of this study are to compare the occurrence and severity of opioid-induced     nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy     of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with     moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the     first metatarsal bone).   "
98021|NCT02003157|"     The purpose of this study is to compare the clinical benefits that can be expected by the     Embryo transfert procedure with hypnosis to the usual embryo transfer procedure   "
62867|NCT02462759|"     The primary objective of Part 1 of this study is to assess the safety and tolerability of     Nusinersen in participants with SMA who are not eligible to participate in the clinical     studies ISIS 396443-CS3B (NCT02193074) or ISIS 396443-CS4 (NCT02292537). The secondary     objective of Part 1 of this study is to examine the pharmacokinetics (PK) of Nusinersen in     participants with SMA. The primary objective of Part 2 of this study is to assess the     long-term safety and tolerability of Nusinersen in participants with SMA who participated in     Part 1 and completed their End of Part 1 Evaluation assessments. The secondary objective of     Part 2 of this study is to examine the PK of Nusinersen in participants with SMA who     participated in Part 1 and completed their End of Part 1 Evaluation assessments.   "
62868|NCT02462746|"     The purpose of this project is to study the effect of dietary supplementation with a natural     health product (NHP) with a focus on its effects on its levels in breast milk.   "
62869|NCT02462733|"     Self-control has become a strong predictor of academic success and life outcomes. Early     childhood development research indicates that greater self-control can lead to better health,     greater wealth, and less propensity to engage in criminal activity. This study seeks to     assess the strength of the play-based Tools of the Mind (TOM) program in improving     preschoolers self-control. It will compare TOM to an alternative play-based program, called     Playing to Learn (PTL), implemented in most YMCA Canada childcare settings across the     country. This study hypothesizes that measures of self-control and other measures of social     behavior and academic success in preschoolers after two years in the TOM program will be     greater than measures of self-control and other measures of social behavior and academic     success in preschoolers in the PTL program after two-years.   "
62870|NCT02462720|"     The purpose of this study is to evaluate pain the patient experienced following treatment of     varicose veins with Varithena® compared to radiofrequency ablation.   "
62871|NCT02462707|"     The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014     single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics     and the overall safety profile of PF-03084014 will also be evaluated.   "
62872|NCT02462694|"     Suicide is a pressing problem in the US military, with evidence of increased risk for suicide     particularly among soldiers serving in Iraq and Afghanistan. To date, there are very few     studies that empirically evaluate treatment efficacy to prevent suicide. One treatment that     has been shown empirically to decrease suicidal behavior is Dialectical Behavioral Therapy     (DBT), although these studies have been limited to patients with borderline personality     disorder (BPD). The current proposal aims to examine the efficacy of DBT in reducing suicidal     behavior more broadly in a diagnostically heterogeneous group of veterans with high risk     suicidal behavior. One of the difficulties in doing research in suicide prevention is that     serious suicidal behavior is a relatively rare event, and alone is not a satisfactory target     for treatment studies. It is extremely important, therefore, to identify intermediate     symptoms that are closely associated with high risk suicidal behaviors, as targets for     treatment. One critical area our proposal addresses is validating new treatment models for     suicide in veterans; DBT has been empirically validated to reduce suicidal behavior in     individuals with BPD, but has not been tested more broadly to target suicidal behaviors. The     second critical area which our proposal addresses is exploring new suicide risk assessment     measures. While the investigators do not specifically propose to develop new screening tools,     the investigators do propose to identify potentially important domains that specifically     differentiate ill high risk suicide veterans from low risk. This information will be useful     in future efforts to modify the DBT approach to be more effective for the broader diagnostic     group of high risk suicidal veterans.   "
62873|NCT02462681|"     This study aims to investigate the safety and the analgesic efficacy of adding Ketamine to     bupivacaine 0.25% in thoracic PVB in patients undergoing modified radical mastectomy.   "
62874|NCT02462668|"     This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted     intubation during noninvasive positive pressure ventilation in respiratory failure patients.     Half of the participants will receive preoxygenation with noninvasive ventilator and     fibreoptic bronchoscopy intubation during NIPPV. While the other half using usual     preoxygenation(bag-mask ventilation ).   "
62885|NCT02462525|"     This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety,     pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with     relapsed and refractory multiple myeloma.   "
62886|NCT02462512|"     For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be     an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure     and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria     for determining which nodule should be be aspirated are needed. Ultrasound elastography has     been shown to be useful in the differential diagnosis of breast and prostate cancers.     Ultrasound elastography also may discriminate malignant from benign nodule.   "
62887|NCT02462499|"     The aim of the study is to determine the efficacy and safety of treatment with the drug     eplerenone in patients with chronic central serous chorioretinopathy.   "
62875|NCT02462655|"     Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by     mutations in the LDL receptor gene that disrupt the normal clearance of LDL particles from     the plasma compartment. Heterozygous patients present a 2- to 3-fold raise in plasma     LDL-cholesterol (C) concentrations, tendinous xanthomatosis and premature atherosclerotic     coronary heart disease (CHD), usually occurring between the age of 35 and 55 years. Since the     mid-1970s, LDL-C has been removed from the blood of patients using plasmapheresis, and this     technique has been shown to improve the life expectancy of FH homozygotes. LDL apheresis     selectively removes LDL particles but not immunoglobulins and other beneficial proteins,     thereby overcoming a potential drawback of the traditional plasmapheresis method. LDL-C is     effectively reduced by more than 60% immediately after LDL apheresis, although LDL levels     rebound rapidly.      Dextran sulfate adsorption is a commonly apheresis technique used in familial     hypercholesterolemia patients. In this apheresis plasma is separated from red blood cells and     passed over columns of cellulose beads containing dextran sulfate which binds apolipoprotein     B (apoB) by a highly selective electrostatic binding mechanism. Since LDL, very-low density     lipoprotein (VLDL), and Lipoprotein (a) all contain apoB, dextran sulfate adsorption     apheresis selectively reduces these lipoproteins while having little effect on the non-apoB     containing HDL particles. In clinical practice, LDL apheresis reduces the rate of future     cardiovascular events and has been postulated to have additional effects on potentially     pro-atherogenic factors. Some proteins have been identified with adhesive characteristics to     lipoproteins, rheological, immunological and inflammation relevant proteins16-19 that     influence microcirculation as well as the inflammatory response. However, no studies have yet     to investigate the impact of LDL apheresis on the expression of different genes involved in     cardiovascular disease.      The main objective of the present research project is to investigate the impact of the LDL     apheresis dextran sulfate adsorption system on the messenger ribonucleic acid (mRNA)     expression of genes involved in cardiovascular disease using microarrays analysis in 9 FH     homozygotes.   "
62876|NCT02462642|"     The Indian Ayurvedic herb Brahmi (Bacopa monniera) has been used to improve cognitive     functions in Indian sub-continent for many years and previous intervention studies have shown     positive effects of Brahmi on cognitive performance in adults. However, the studies are     conducted on various fractions and extracts and there is high likelihood of variability of     composition amongst the fractions/extracts tested in these studies. Furthermore, although the     findings of the previous studies overlap to some extent, they are not consistent and there is     a need to replicate these findings.      Further, even though Brahmi has been studied for its chemical composition and its therapeutic     benefits as a whole, there are still severe gaps with respect to the complete composition of     the Brahmi plant or its extracts. No published data exist on the Pharmacokinetics (PK)     properties of Brahmi components. Hitherto, the evidence and the mechanistic details are still     speculative and the biological activity is still phenomenological. Because of this severe     knowledge gap, this study will try to repeat the findings on cognitive performance and at the     same time also explore the plasma levels of its components in order to initiate the     understanding of ADME aspects and its linkages to the biological effect.   "
62877|NCT02462629|"     Many types of cancer are primarily treated with surgery and patient survival is directly     related to the extent to which the tumor is able to be removed. It is often difficult for     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have     spread from the original tumor site, resulting in incomplete removal of the tumor and reduced     patient survival. In some sites, such as the brain, it is critical to avoid damage to normal     tissue around the tumor to prevent adverse effects of surgery on function. The investigators     hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the     edges of the tumor and small groups of cancer cells that have spread to other sites in     real-time as they operate. This is a safety study to assess the safety of BLZ-100 in     pediatric patients with central nervous system tumors.   "
62878|NCT02462616|"     This is a large-scale, community-based, cross-sectional study to evaluate environmental and     genetic risk factors for cardiovascular autonomic neuropathy in general Chinese population.   "
62879|NCT02462603|"     Open-label study with 30-day run-in phase and adaptive design component to include more     subjects if deemed appropriate by investigators.   "
62880|NCT02462590|"     Probiotics are commercially available live bacteria thought to have health benefits when     ingested. A literature review of probiotic studies in the intensive care unit (ICU) found     that in patients who receive probiotics, there is a 25% reduction in lung infection, known as     ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of     developing any infection in the ICU. However, the studies reviewed were small and not well     done. Therefore, whether probiotics are really helpful or not is unclear. Before a large     carefully performed study is done to evaluate the effects of probiotics in critically ill     patients, a pilot trial was needed. The Investigators completed a multicenter pilot RCT for     which the primary outcomes relate to feasibility. Feasibility goals were met. 1) Recruitment     for the Pilot was achieved in 1 year; 2) Adherence to the protocol was 96%; 3) There were no     cases of contamination; 4) The VAP rate was 15%. This study is very important in the ongoing     search for more effective strategies to prevent serious infection during critical illness.     Probiotics may be an easy-to-use, readily available, inexpensive approach to help future     critically ill patients around the world.   "
62881|NCT02462577|"     This study investigate the effect of addition morphine to locally instillation bupivacaine on     developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and     on the probability of developing chronic neuropathic pain.   "
62882|NCT02462564|"     Objectives to investigate the incidence and associated factors for early postoperative     cognitive dysfunction in the patients with peritoneal surface malignancies undergoing     cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods fifty     patients aged 18-65 yr were included in the research and were grouped base on the score of     neuropsychological assessments which had done in the ward at 7 day before and after the     surgery. The investigators monitored various indicators in the perioperative period, such as     age, body weight, sex, education, duration of operation, intraoperative blood loss,     cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of     serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at     the various stage of the operation and 24 hours after the operation, and the differences of     data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.   "
62883|NCT02462551|"     The purpose of this study is to determine the efficacy and any possible side effects of focal     electrically administered seizure therapy (FEAST) as a treatment intervention for patients     with recurrent and treatment resistant depression.   "
62884|NCT02462538|"     This is an open label pilot study of combining BV in a licensed indication with imatinib in     patients with ALCL. It is intended as a window of opportunity trial in which the study     drugs will be given as an initial substitute for conventional chemotherapy with the intention     to achieve a remission enabling the patients to proceed to autologous or allogeneic stem cell     transplantation, if eligible.   "
62890|NCT02462460|"     The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be     used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently,     Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45     minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation     that can be used as a screening tool that is completed in approximately 15 minutes. They will     compare different tools available on modern MRI scanners to see which one reliably offers     high quality images of the pancreas and ovaries.   "
62891|NCT02462447|"     Men with and without prostate cancer will have a PET/CT scan that measures the level of the     amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.   "
62913|NCT02462161|"     This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition,     daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid     deposition in the brain. Participants will be randomly assigned to receive insulin aspart or     placebo during a 12-week treatment period.   "
62914|NCT02462148|"     This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve     blocks.   "
62893|NCT02462421|"     Sodium-dependent glucose transporter-2 (SGLT2) inhibitors are a new class of anti-diabetic     drugs, which increase urinary glucose excretion thereby promoting weight loss and decreasing     plasma glucose levels. We hypothesize that the pharmacodynamic response to SGLT2 inhibitors     (specifically canagliflozin) varies among individuals, and that a proportion of this     inter-individual variation can be explained by genetic variation. This is a pilot study in     healthy, non-diabetic subjects in whom glucose and other related metabolites in the urine and     plasma will be measured before and after administration of a single dose of canagliflozin.     This will allow us to characterize the inter-individual variation in the pharmacodynamic     response to canagliflozin as well as determine if changes in glucose and other related     metabolite levels are associated with variants in various candidate genes.   "
62894|NCT02462408|"     The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided     infraclavicular brachial plexus block. However this technique is less popular because     brachial plexus at the infraclavicular level runs deeper compared to its course proximally,     often give rise to impaired needle visualisation due to its steep angle of needle trajectory     to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to     improve needle visibility. This approach proved feasible from our case series hence the     investigators would like to compare it with the conventional method in this study   "
62895|NCT02462395|"     Cluster headache is a primary headache that chiefly affects young men, and is less common     than migraine. This disease can have devastating consequences due to the pain intensity (it     is also called suicide headache), to the side effects of the drug preventive therapies, and     to the resistance of some subtypes of the headache to all existing medications.      Recent studies suggest that cluster headache could be associated with a decrease of the     activity of frontal areas involved in descending pain control, in particular the subgenual     anterior cingulate cortex. The aim of this pilot study is to activate these areas with a     non-invasive neurostimulation technique, called transcranial direct current stimulation, as a     preventive treatment for cluster headache sufferers.   "
62896|NCT02462382|"     Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an     outpatient basis. Postoperative pain control regimens can include narcotic pain medicine,     non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene     block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the     shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very     painful when the block wears off. The purpose of this study is to:        1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during          the first two days after arthroscopic rotator cuff repair.        2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and          placebo catheters after arthroscopic rotator cuff repair.        3. Evaluate for any continued pain relief benefit of continuous infusion scalene block          ropivacaine catheters during the three days after the infusion catheters have finished.   "
62897|NCT02462369|"     This study compare the effects on microalbuminuria improvement in type 2 diabetes mellitus     (T2DM) treated with saxagliptin or glimepiride.All patients received metformin and/or     acarbose, and randomly receive saxagliptin (5mg/d) or glimepiride (1-4mg/d).   "
62898|NCT02462356|"     This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of     participants will receive multiple VATS, while the other half will receive uniportal VATS     lobectomy.   "
62899|NCT02462343|"     All measurements are performed on two consecutive days at the beginning of a pulmonary     rehabilitation program in a randomized cross-over study design. On the first day, each     patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk     test. On the second day each patient performs the test that was not performed on the first     day. All walk tests are performed by the same investigator on the same track and time of day,     following the 2002 guidelines of the American Thoracic Society.      Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen     saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of     perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are     recorded at rest after 10 minutes of sitting.   "
62900|NCT02462330|"     Stem cell therapy is an emerging treatment for cardiovascular disease but the best cell type     and delivery method remain to be determined. Pre-clinical studies demonstrated improvement of     cardiac function by Mesenchymal stem cells (MSC) therapy in particular by their paracrine and     immunosuppressive properties. Investigators initiated the MESAMI program by the bicentric     pilot phase and highlighted the safety and feasibility of intramyocardial injections of MSCs     from bone marrow in patients with chronic ischemic cardiomyopathy and left ventricular     dysfunction, guide by the NOGA-XP system. The MESAMI program continues with the phase 2,     multicenter, double-blind, randomized, placebo-controlled trial.The aim of this phase 2 study     is to demonstrate a functional improvement, measuring peak VO2, at 3 months between the cell     therapy group and the placebo group.   "
62901|NCT02462317|"     Stroke is the first cause of motor impairment and disability in adults. Then the main     objective of rehabilitation during the first six months following stroke is to facilitate     motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an     increase of disability. Then antispastic drugs are frequently prescribed to the patients even     during the post-stroke recovery phase. Until recently most of french patients were treated by     oral tablets of baclofen. Now the number of patients receiving intramuscular injections of     botulinum A toxin is increasing. However in the literature, these drugs have been tested in     post-stroke spasticity during the chronicle phase, after the sixth month and their action on     motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the     effects of its drugs on motor recovery. The main criterion of its study is the time course of     Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two     months, will be included in the try. They receive at the same time oral tablets for five     months and intramuscular injections. Patients are randomized in three arms planned with a     distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and     placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients),     placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed     before treatment start, one month and three months later. Spasticity, functional abilities,     capacity in the activities of daily life, pain and quality of life will be also assessed     during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin     score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive     difference of 12 points in the time course of FMA in the botulinum toxin group in comparison     with the baclofen group will be considered as the minimum relevant effect. 300 patients have     been planned to be included in 20 centers during the 2 years of trial.   "
62915|NCT02462135|"     This study sought to investigate the changes in objective memory performance (including     immediate recall and delayed recall), subjective memory complaints and degree of depression     in older adults with mild cognitive impairment after Virtual interactive memory training     (VIMT).   "
62902|NCT02462304|"     Objectives:      To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor     (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth     Factor and end-point-management grid laser photocoagulation for diabetic macular edema.      Study design:      Open-label non-randomized interventional study.      Study overview:      This study aims to look at the efficacy of treating diabetic macular edema (DME) with either     anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination     therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a     period of 6 months.      Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending on     the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy'     arm, or to the 'Combination therapy' arm.   "
62903|NCT02462291|"     Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of     disability with elevated social costs. Alternative solutions to the standard pharmacological     therapies have been studied in order to reduce the use of medications that frequently     generates side effects and worsen patients' quality of life. A recent alternative treatment     for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic     gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this     approach is still mater of debate. Therefore, the aim of this trial will be to analyze the     effects of EET, in people with severe AD.   "
62904|NCT02462278|"     This study evaluates the safety and usability of a continuous temperature sensor for women.     Data will compare the date of ovulation identified by the continuous temperature sensor to     that of transvaginal ultrasound and serum progesterone levels. Subjects will also compare     sensor results to once-daily oral temperatures and urine luteinizing hormone (LH) status.   "
62905|NCT02462265|"     The study will be a prospective open-label single-center study in previously treated patients     with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and     safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi     carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to     have anti-tumor activity and good safety profile.      Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage     chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to     multiple dose regimens of Oshadi D and Oshadi R.      Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post     therapy initiation.   "
62906|NCT02462252|"     An open label single arm study to assess efficacy and safety of BL-8040 on top of standard     immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS and     AA over the course of a six month (180 day) treatment period.   "
62907|NCT02462239|"     Bladder cancer is the fifth most common cancer in Canada and there has been relatively little     progress in altering its clinical course over the last three decades. One of the major     problems identified in the management of this disease, is under staging of muscle invasive     disease which can lead to suboptimal treatment and outcomes. PET-CT has the potential to more     accurately stage MIBC than standard CT by detecting pelvic adenopathy and/or distant sites of     disease that may not be found on standard imaging. In the former situation, more aggressive     therapy with extended lymph node dissection and/or neoadjuvant chemotherapy prior to     cystectomy can be offered. While in the latter situation patients can be spared the morbidity     of a cystectomy performed in a setting of metastatic disease. This study will address whether     PET-CT adds a clinically meaningful difference in care.   "
62908|NCT02462226|"     The purpose of this research study is to conduct a randomized clinical trial to evaluate the     efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and     symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary     outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index,     quality of life related to pain.      Recruitment includes 120 patients who will be randomized according to pain/aching/soreness,     and tenderness. Participants in the intervention group will be provided the web-based     The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program     during the 1-4 weeks of the study. Participants in the control group will receive the     web-based arm precaution program. All the participants will have monthly online assessment of     pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research     visits, that is, prior to intervention and 12 weeks post-intervention.   "
62909|NCT02462213|"     Cardiac amyloidosis describes a process by which abnormally folded proteins infiltrate the     heart tissue. Given the insidious nature of this disease process, diagnosis is often too late     for a meaningful intervention. Advances in the treatment of the amyloidoses have improved     outcomes for patients with these conditions. The focus of this study is to identify the     involvement of the heart, most closely associated with mortality, so that aggressive     management can be instituted improving prognosis.   "
62946|NCT02461732|"     The purpose of the study is to determine whether a novel integrated cognitive-behavioral     treatment for posttraumatic stress disorder (PTSD) and substance dependence (i.e., Treatment     for Integrated Posttraumatic Stress and Substance use; TIPSS) is more effective than     cognitive-behavioral treatment for substance dependence alone with regard to PTSD symptoms     and substance use quantity and frequency.   "
62910|NCT02462200|"     The investigators propose a randomized controlled superiority trial of standard     breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main     objectives of this trial will be to evaluate prospectively the impact of routine standardized     CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II),     on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative     time and operative costs. A parallel group format will be implemented to compare this     modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of     care.   "
62911|NCT02462187|"     This is a randomized, double-blind, vehicle-controlled, ascending dose study to assess     safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects     with external genital and perianal warts. Eligible subjects will be treated with a topical     gel (active or vehicle) for up to 12 weeks.   "
62912|NCT02462174|"     To find alternatives to caudal analgesia that could be more safe and effective and to     demonstrate the analgesic efficacy of topical ketamine.   "
62916|NCT02462122|"     Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis   "
62921|NCT02462057|"     The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage     healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled     in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy     foods they purchase at selected grocers. And, while overall enrollment in the program is     high, there is particular interest in increasing enrollment in the benefit amongst Vitality     members with diabetes. One presumed barrier to enrollment in the benefit amongst members with     diabetes is a misperception of the particular relevance of the benefit and healthier food     choices for their personal health. Improved messaging regarding the HealthyFood benefit and     its particular salience for individuals with diabetes may be an effective means of increasing     activation of the benefit in this population. The proposed study will be a collaboration     between Discovery Health/Vitality and researchers at the Perelman School of Medicine at the     University of Pennsylvania. In the proposed RCT, Vitality members with diabetes will be     randomised to different types of messages regarding the HealthyFood benefit. The     investigators will then compare the effectiveness of these different messaging strategies at     increasing activation of the HealthyFood benefit amongst Vitality members with diabetes.   "
62922|NCT02462044|"     Computed tomographic angiography (CTA) is an important prognostic tool with regard to the     detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine     delivered to the patient per second) and iodine concentration are decisive factors in the     opacification of arterial vessels.      There remains to be some debate in the literature about whether the use of high iodine     concentration contrast media is beneficial compared to lower iodine concentrations.      To date, there have not been any studies comparing intracoronary attenuation using     concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison     of CM with different iodine concentrations, adapted injection protocols insuring an identical     IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower     iodine concentrations, while maintaining identical IDR and total iodine load, will result in     comparable diagnostical intra-vascular attenuation in CTA.   "
62923|NCT02462031|"     To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral     dosing in the fed state in obese or overweight subjects.   "
62937|NCT02461849|"     KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series     of downstream effector pathways. KIT is an established therapeutic target in cancer with     activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant     benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate.     Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic     targets in melanoma. Additional information is required to characterize the functional role     of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is     a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid     cancers were reported to have KIT mutation even in low frequency. A molecular profiling of     the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center     showed KIT mutation in 7 patients in total of 431 patients (2%).      Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib     to various types of cancers harboring KIT mutation or amplification.   "
62947|NCT02461719|"     The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic     nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group     12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and     safety in Moderate to Severe Dry Eye Disease.   "
62924|NCT02462018|"     Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from     a non-progressive injury during early brain development which leads to impairment of movement     and posture.      Muscle weakness and spasticity associated with CP limit the joint range of motion and     negatively impact ambulatory ability. Most ambulatory children with CP are prescribed with     ankle-foot orthoses (AFOs) to improve ankle position and stability and to maintain muscle     range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle     weakness and atrophy.      During the last years a novel method is being used for treating upper motor neuron drop foot,     by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).      These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating     the tibialis anterior muscle. Most of the studies of FES devices were conducted on adult     population. These studies showed improvement in laboratory and functional gait parameters.     There are relatively few studies on children with hemiplegic or diplegic CP with favorable     results. There is no solid evidence whether the improvements seen in laboratory setting of     children with CP, are reflected on functional ambulation in daily life. In addition, there     are no defined parameters which could predict the response to FES among those children.      The aim of this study is to determine whether using FES device (WalkAide; Innovative     Neurotronics, Austin, TX, USA) improves daily motor function and gait parameters in children     with spastic hemiplegic or diplegic CP. additionally, we aim to define clinical and     biomechanical parameters that can predict a favorable response to using the FES device.   "
62925|NCT02462005|"     A total of up to 250 patients from an all-comers patient population with infrainguinal     atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug     coated balloon.      Interim analysis will be carried out for every 50 subjects enrolled.   "
62926|NCT02461992|"     An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC),     Recombinant Factor VIII) in male Chinese subjects with hemophilia A   "
62927|NCT02461979|"     Previous data have suggested that vitamin D levels may influence cancer development. In     particular, several single nucleotide polymorphisms have been described in the Vitamin D     receptor( VDR gene), and some polymorphisms are associated with tumor occurrence. For     instance, VDR polymorphisms have been related to cancers of the breast, prostate, skin,     colon-rectum, bladder and kidney, although with conflicting observations . VDR polymorphisms     have also been investigated in the context of some chronic liver diseases, such as chronic     hepatitis B, primary biliary cirrhosis and autoimmune hepatitis . In a recent published     study, VDR polymorphism may be used as a molecular marker to predict the risk and to evaluate     the disease severity of HCC in patients with chronic hepatitis B.      A significant association of VDR (ApaI) polymorphism with the development of HCC in chronic     HCV infection may help to identify those who are at high risk of developing HCC.   "
62928|NCT02461966|"     Hepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the blend     of risk factors differs in different parts of the world, and this may explain in part the     diverse biologic characteristics of HCC in different populations .      Exposure to aflatoxin is an additional risk factor for the development of HCC, through damage     of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study showed     that aflatoxin B1 has a considerable role in the development of HCC among Egyptians .      Clinical studies have shown that AFB1 selectively targets at the third base position of codon     249 of the human p53 gene, a known mutational hotspot in human hepatocellular carcinoma (HCC)     . A significant association between aflatoxin exposure and HCC has been reported in     hyperendemic areas . A synergistic interaction between AFB1 exposure and viral hepatitis B     (HBV) infection on HCC risk has been reported in several epidemiologic studies.      Aflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C (HCV)     patients. Levels of AFB1-albumin/albumin were significantly related to ultrasono-graphic     hepatic parenchyma scores in anti-HCV-positive subjects .   "
62929|NCT02461953|"     This study is a prospective, randomized, controlled multicenter clinical study. The aim of     the study is to investigate whether the combination of maintenance hemodialysis (MHD) with     hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic     toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.   "
62930|NCT02461940|"     A randomized controlled trial conducted on 688 sexually experienced adolescents, with 337     participants assigned to the routine program, and 351 to the new intervention developed from     an assessment of their needs. All participants will complete a self-administered     questionnaire and an interview on their knowledge of sexually transmitted infections     (STIs)/Human Immunodeficiency Virus (HIV), self-efficacy, skills in negotiating for sexual     abstinence or condom use, and sexual behaviors at baseline and at 6- and 12-months' post-     intervention. All will be tested for STIs. Participants in the intervention group will     receive 4 individual counseling sessions on STIs/HIV knowledge, life skills, secondary     abstinence, safer sex and healthy relationships over 1 year. They will also be referred to     counselors for proactive social and emotional support delivered through electronic media and     other means. The control group will receive the usual counseling session at first and     follow-up clinic visit.   "
62931|NCT02461927|"     The investigators propose an 8-week, randomized, double-blind, placebo-controlled,     between-subjects trial in which repeated ketamine treatment (0.5 mg/kg; once a week for 4     weeks; a total of 4 ketamine infusions) will be evaluated for safety and efficacy. First,     prior to the double-blind trial, the investigators will conduct an open-label trial that will     include 5 patients with comorbid major depressive disorder (MDD) and alcohol use disorder     (AUD) to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for     4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. Second, after     reviewing the safety and efficacy of repeated ketamine treatment from the open-label trial,     the investigators will conduct an 8-week, randomized, double-blind, placebo-controlled trial     that will include 60 patients with comorbid MDD and AUD to test safety and efficacy of     repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine     infusions) with a follow-up of 4 weeks. The 4-month follow-up session will also occur.   "
62932|NCT02461914|"     To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy     subjects.To provide a scientific basis for clinical drug combination of PEX168.      To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in     healthy subjects.      To assess the safety of single doses of warfarin administered with and without PEX168   "
62938|NCT02461836|"     Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is     the only curable method to treat pancreatic cancer. However, even if radical resection is     achieved, the 5-year survival rate is still low because of tumor recurrence. It's reported     adjuvant radiation can prolong survival and improve quality of life after surgery. For R0     (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value     of adjuvant radiation is still in debate. It's warranted to explore the role of adjuvant     radiation for patients after radical resection of pancreatic cancer with advanced stages (T3     or N1) in large, prospective, and randomized cohorts.      The application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful     and more flexible. It is hoped that adjuvant SBRT may benefit post-operative patients with     advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of     care for pancreatic cancer patients.   "
62939|NCT02461823|"     Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on     periodontal health.   "
62940|NCT02461810|"     The purpose of this study is to compare the safety and effectiveness of the SpineJack® with     the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of     SpineJack® VCF treatment system versus Balloon Kyphoplasty.   "
62941|NCT02461797|"     Recently, a critical role in the development of allergic rhinitis (AR) has been attributed to     the nasal epithelium. The airway epithelium forms a physical barrier, protecting the nasal     mucosa and underlying organs from damage from contact with exogenous particles. The nasal     epithelial barrier is primarily determined by the integrity of the airway epithelium, in     which epithelial cells are connected to each other by complex network structures like tight     junctions (TJs), ultimately sealing off the paracellular space. TJs consist of different     transmembrane proteins including occludin, tricellulin, the claudin family, and junctional     adhesion molecules. TJ form intercellular homodimers/heterodimers between neighboring cells.     Scaffold adaptor proteins like cingulin and the zonula occludens family connect the     transmembrane proteins to the actin cytoskeleton.      Disturbed TJ function can facilitate the entrance of foreign pathogens and antigens into the     submucosal layer, giving raise to allergic sensitization via increased access of allergens to     the dendritic cells and/or inducing persistent inflammation via activation of mast cells and     other inflammatory cells residing in the upper airways. Chronic disorders like allergic     asthma, inflammatory bowel disease and atopic dermatitis have been linked to defective or     altered TJ function. Recently, an impaired epithelial barrier function was found in patients     with chronic rhinosinusitis with nasal polyps (CRSwNP), suggesting changes in TJ arrangement     in the nasal cavity. CRSwNP presents a similar inflammation of the sinonasal cavities as     found in AR patients, i.e. a Th2 cytokine driven inflammation with tissue eosinophilia.     Nevertheless, the role of TJs and its regulation has not been investigated in AR.   "
62942|NCT02461784|"     Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal     tract which includes Crohn's disease (CD) and ulcerative colitis (UC) which peak in incidence     (rate or frequency) during the reproductive years. An increasing number of young people will     face challenging decisions regarding medical management of this chronic disease during a     period of time when they are still completing schooling, establishing their career, and/or     are building a family.      Treatment options for IBD consist of immunosuppressive therapy, such as immunomodulators     (azathioprine and methotrexate). Methotrexate (MTX) is a folic acid antagonist (a substance     that interferes with or inhibits the action of another). It is thought that MTX works by     decreasing the inflammation in the gastrointestinal tract. MTX has been studied for many     years and in used as treatment in not only IBD, but also in conditions such as rheumatoid     arthritis and lupus. However, due to concerns about the safety of MTX, particularly in     regards to fertility and pregnancy has limited its current use.      Participants are invited to take part in this research project to determine whether the     treatment of IBD patients with MTX is associated with an increased risk for infertility.     Investigators will recruit 75 male IBD patients under MTX treatment for their IBD as well as     75 healthy male controls for a total of 150 patients at the University of Wisconsin Hospital     & Clinics.   "
62943|NCT02461771|"     The objective of this study is to provide initial safety, tolerability and pharmacokinetics     information of intravitreal administration of APL-2 in order to support further development     into larger Phase II studies for treatment of patients with AMD.   "
62944|NCT02461758|"     Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal     tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent     epidemiological investigation estimates that nearly 4 million people worldwide are affected     and approximately 1.4 million of these cases occur in the United States. IBD can lead to     debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures     and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic     corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as     tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can     achieve clinical remission and decrease the risk of complications, but also increase the risk     for opportunistic infections, including influenza.      Multiple studies have shown lower influenza vaccine responses in patients with IBD compared     to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF     inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza     serum antibody concentration correlates with protection from infection following vaccination.     Therefore, increasing influenza antibody responses in patients with IBD would appear to be     critical to improving protection from influenza. A high dose (HD) influenza vaccine     containing four times more hemagglutinin was licensed based on its ability to induce higher     antibody concentrations compared to standard dose (SD) in adults 65 years or older.   "
62945|NCT02461745|"     This is a Phase IV, open-label, multi-center study to evaluate the real world sustained     virological response rate, subject adherence, and subject reported outcomes during and after     treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older,     with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasubuvir), with or without ribavirin.   "
63001|NCT02461004|"     A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety     CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.   "
98022|NCT02003144|"     The purpose of this study is to determine whether eculizumab long-term use is safe and     effective in patients with relapsing NMO.   "
62948|NCT02461706|"     The main goal of this study is to provide treatment with cannabidiol (CBD) to children with     drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol.     As the controlled therapeutic use of CBD in children is novel, the primary objective of this     study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy     in children that have exhausted the majority of FDA approved antiepileptic drug treatment     options.   "
62949|NCT02461693|"     The purpose of this project is to examine the effect of expectancy on mood and alertness     after consumption of caffeine treatment or placebo control pill, given that participants     know their probability for receiving the caffeine versus placebo pill. Participants will be     randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and     this probability will be revealed to them before consumption of the assigned pill and     subsequent cognitive testing. At the time of consumption, neither study staff administering     the intervention nor participants will know for certain which pill is given to each     participant. Pill assignment will depend on pre-determined randomization probabilities, which     will be provided and assigned by the study statistician. By revealing participants'     individual probability of receiving the caffeine pill, we will induce positive or negative     expectancies regarding likelihood for receipt of the caffeine pill. These experimental     manipulations will: 1) estimate the effect of expectancy on cognitive and affective outcomes,     and 2) allow for a more direct estimate of the effect of the caffeine pill under real-world     conditions than would a conventional randomized trial.   "
62950|NCT02461680|"     Flexors tendon injuries are frequent and serious with a potential of definitive functional     aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques     of possible repair, the direct suture and the tangential resection. The investigators have     already demonstrated that this last technique was favorable for injuries going to 50 %. In     the case of partial section between 50 and 75 %, the investigators think that the technique     of tangential resection compared with the direct suture would not increase the risks of     secondary breaks, would authorize even an immediate mobilization and would decrease the     secondary complications.      The main objective is to highlight that the tangential resection is not lower than the     classic technique on the clinical plan The secondary objectives are to highlight the     non-inferiority of the tangential technique in clinical terms (pains, dexterity,     complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures     and professional activities)   "
62951|NCT02461667|"     This is a 9 month randomised controlled clinical comparing the clinical efficacy of     1%metformin and 1%alendronate in chronic periodontitis subjects.   "
62952|NCT02461654|"     In this prospective observational trial the effect of the Disc FX microinvasive therapy     should be examined in (approximately 150) adult patients with low back pain.   "
62954|NCT02461628|"     The overall objective of this study is to evaluate the public health impact of targeted     antimalarials subsidies through scale-up by determining the community-wide effects of     targeting an antimalarial subsidy through a partnership between Community Health Volunteers     (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a     fixed-price voucher that reduces the cost for ACT purchase in the retail sector conditional     on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and     will increase the proportion of fevers tested for malaria before treatment. The study will be     carried out in two sub-counties in Kenya with similar malaria burden but different access to     health services; the investigators will use a cluster-randomized design to assign community     units (CUs) in each sub-county to either an intervention or control arm. CHVs will be trained     to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household members with     documented or reported fever; households in intervention CUs will be informed of the     intervention and encouraged to contact the CHV for any febrile illness in the home. There are     minimal risks associated with receiving an RDT. Households with a positive RDT will be given     a serialized voucher that will entitle the holder to purchase a quality assured ACT in the     retail sector at a reduced, fixed price. The primary and secondary outcome measures will be     compared at baseline and 12 months post-baseline through population-based surveying.     Population-based surveying conducted at 6 months and 18 months post-baseline will provide     additional information. The primary aim is to determine whether there is significant     difference between the 2 study arms in the proportion of clients with fever who are tested     prior to any treatment after adjusting for relevant covariates.   "
62955|NCT02461615|"     The major goal of this study is to establish a National PAP Registry to help make reliable     new research tests available to doctors to improve the diagnosis of PAP, increase awareness     and knowledge of PAP, and give patients a 'seat at the table' in planning and conducting PAP     research including the clinical testing of several new potential therapies.   "
62956|NCT02461602|"     ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial     Fibrillation Patients) is a two year research project to assess warfarin management issues     faced by atrial fibrillation (AF) patients in ambulatory settings.   "
62957|NCT02461589|"     This trial is conducted globally. The aim of this trial is to investigate dose-finding of     semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects     with type 2 diabetes   "
62958|NCT02461576|"     Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA     quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.   "
62959|NCT02461563|"     This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to     suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose     administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and     well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction     is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration     of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.   "
62960|NCT02461550|"     The investigators are investigating the use of a new cancer treatment called Irreversible     Electroporation (IRE). This treatment delivers electrical energy between two needles placed     in a cancer. The electrical energy causes cells to die. While this has been used in patients     for different applications, the investigators are trying to understand how safe and well it     works in colon cancer that has spread to the lung. Once the irreversible electroporation     procedure is completed during the operation, the surgeon will then remove the cancer     according to standard procedure. As part of the study, they will be measuring safety of the     electrical energy delivered and will be reviewing the resected specimen under the microscope.   "
62961|NCT02461537|"     This trial compares outcome of two treatment strategies for patients with high-risk AML who     failed to achieve or maintain a complete remission with standard therapy. Patients will be     randomized between two strategies. The standard strategy is aimed at achieving a complete     remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, .     The alternative is a less toxic disease-control strategy of disease monitoring and, if     necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which     should be performed as soon as possible.   "
62962|NCT02461524|"     The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo AAA     (Abdominal Aortic Aneurysm) Stent graft system for endovascular treatment of subjects with     infrarenal abdominal aortic or aortoiliac aneurysms.   "
62963|NCT02461511|"     To Assess the impact of therapeutic education on:        -  the occurrence of long term diabetes complications .        -  balance of his diabetes   "
62964|NCT02461498|"     Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing     patients taking warfarin after a blunt head injury is variable with little research that     supports the most appropriate way to manage these patients. The investigators aimed to     undertake research in order to understand the range and frequency of outcomes following head     injury in this group of patients and to develop robust clinical guidance for how they should     be optimally managed in the future.   "
62965|NCT02461485|"     First experimental study (Proof Of Concept) to investigate bowel function parameters on which     a fermented milk product with probiotics alone or in association with fibers has a potential     effect.   "
62966|NCT02461472|"     A large-scale, community-based, cross-sectional study was conducted to explore the extent to     which risk factors associated with diabetic cardiovascular autonomic neuropathy (DCAN) in     general Chinese population. A total of more than 2000 diabetic participants were recruited by     using multiple stages sampling (first cluster sampling and then simply sampling). Data     involved in demographic information, clinical biomarkers such as glucose and lipids profiles,     medical and therapy history were collected. Every participants was complete DNA extracted and     genotyped. Diabetic Cardiovascular autonomic functions were measured by using short-term     heart rate variability (HRV) to evaluate the outcome of DCAN. Univariate and multiple     variables analysis have been performed to examine potential environmental and genetic risk     factors of CAN. In addition, clinical risk model, simply screening model and nonlinear system     model such as artificial neural network was created, respectively.   "
62967|NCT02461459|"     The purpose of this study is to characterize the developmental phenotype of ASD and ID and     identify biomarkers using advanced MRI methodology predictive of ASD and ID presence and     severity in pediatric patients with TSC. In addition, this study will be establishing     infrastructure for the collection and storage of human bio-specimens, including genetic     material, from TSC patients and their family members with ASD.   "
62992|NCT02461121|"     Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is     assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is     assigned to receive MST therapy without GVHD prophylaxis.   "
62968|NCT02461446|"     The purpose of this study is to determine cross-sectional and longitudinal medical,     behavioral, and cognitive differences between PTEN ASD and other groups, as well as to     identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In     addition, this study will be creating and maintaining a biorepository and linked phenotypic     database for PTEN ASD.   "
62969|NCT02461433|"     The purpose of this study is to determine whether application of an incisional wound Prevena     trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical     patient will reduce surgical site infections (SSI) when compared to the standard of care     dressing.   "
62970|NCT02461420|"     The purpose of this study is to comprehensively characterize PMS using standardized medical,     cognitive, and behavioral measures and to track the natural history of the syndrome using     repeated longitudinal assessments. In addition, this study will be aiming to identify     biomarkers using neuroimaging, including difusion tensor imaging and identify genetic factors     which contribute to diverse phenotypes in patients with PMS.   "
62971|NCT02461407|"     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in     patients with Gastric Cancer.   "
62972|NCT02461394|"     The user performance evaluation shows whether people with diabetes are able to obtain     accurate measurement results with a blood glucose monitoring system. In this study, user     performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care),     Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch     Select Simple (LifeScan) following ISO 15197:2013, clause 8.      The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.      For each BGMS, measurement procedures for user performance evaluation will be performed with     1 test meter and 1 reagent system lot by the study subjects.      The same meter and an additional test meter will be used for double measurements performed by     study personnel (with the same reagent system lot used by subjects).   "
62973|NCT02461381|"     This study aimed to estimate sensitivities and specificities of diabetic cardiovascular     autonomic neuropathy (DCAN) diagnostic tests using the Bayesian approach without a gold     standard in another independence dataset.The reference the values for the short-term HRV were     calculated in the investigators' previous study (including 371 healthy subjects). This study     dataset contained 200 diabetic patients who completed both the short-term HRV test and     Ewing's test. Simultaneous inferences about the population prevalence and the performance of     each diagnostic test were possible using the Bayesian approach without a gold standard.   "
62974|NCT02461368|"     The investigators compared the results of the ultrasound-guided anterior and posterior     approaches to administer glenohumeral steroid injections to patients with primary adhesive     capsulitis of the shoulder joint by a single experienced provider.   "
62975|NCT02461355|"     This is a randomized, crossover design trial that will compare how anodal transcranial direct     current stimulation (tDCS) versus sham tDCS administered during multiple sessions of     scripting therapy affects the acquisition and retention of trained scripts.   "
63002|NCT02460991|"     This is a prospective, multicenter study that will be conducted at up to 40 centers in the     United States and Outside United States (OUS). Participants in the study will be randomly     assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the     study participants' outcomes (medical condition) after being treated with ONCO-DOX and     compare it to those treated with sorafenib alone.   "
62976|NCT02461342|"     A large-scale, community-based, cross-sectional study was conducted to explore the extent to     which genetic, environment and its interactions associated with cardiovascular autonomic     neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were     recruited by using multiple stages sampling (first cluster sampling and then simply     sampling). Data involved in variables of genetic, environment were collected. Every     participants was complete DNA extracted and genotyped by using single nucleotide polymorphism     (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate     variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate     genetic variants, environmental risk factors and its interactions for CAN.   "
62977|NCT02461329|"     The purpose of the study is to determine whether volume therapy with a solution of gelatine     has negative impact on coagulation, platelet function, renal function in comparison with     crystaloid solution (Ringerfundin).   "
62978|NCT02461316|"     Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with     chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic     Leukemia (CLL).   "
62979|NCT02461303|"     Klinefelter syndrome is characterized by primary testicular failure and progressive     infertility. The objective of this study is to determine if sperm are present and can be     observed in urine and semen samples of adolescent and young adult Klinefelter patients and to     determine whether the presence of sperm correlates with physical and/or clinically obtained     hormone measures of pubertal development.      This study was designed in order to answer the following questions:        1. Is it possible to observe sperm in urine samples of adolescent and young adult          Klinefelter patients?        2. Is it possible to retrieve sperm for cryopreservation from semen samples of adolescent          and young adult Klinefelter patients?        3. Does the presence of sperm correlate with the physical and/or endocrine measures that          are assessed during routine clinical evaluations of pubertal development in the KS          patient population?        4. If sperm retrieval is possible, what is the optimal age at which sperm retrieval should          be attempted?   "
62980|NCT02461290|"     The primary objective is to evaluate the safety profile and tolerability of rituximab in     combination with different chemotherapy regimens.   "
62981|NCT02461277|"     The aim of this study was to compare the functional capacity of exercise by six-minute walk     test before and after thoracic surgical procedure in subjects who have undergone the     Fast-track protocol with those who were under conventional care. Researchers want to find out     if Fast-track is a strategy to enhance functional capacity after thoracic surgery.   "
62993|NCT02461108|"     The investigators hypothesize that monetary incentives and messaging, such as making     nutritious foods relatively less expensive than less nutritious foods and framing the price     difference in a positive or negative way, will influence purchasing behavior of households.   "
62982|NCT02461264|"     Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic     stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit     hematology require compensation of anemia and thrombocytopenia by blood transfusions of red     blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de     Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to     transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g /     dL. These recommendations allow to transfuse a single RBP for very elderly patients or in     cases of associated heart disease (heart failure). A recent development (2012) on     post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk     patients.      More recently, a Swiss team has historically compared transfusion policies in 2 139 patients     with hematological malignancies. The first group received 2 RBP transfusion in case of     symptomatic anemia or hemoglobin level <6 g / dL. The other group only received 1 RBP at each     transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP     transfusion policy has resulted in a 25% decrease in the number of RBP used without any     complication. In a prospective single-center pilot study, we showed that transfusing a single     RBP was possible without increasing the side effects of anemia, without complications and     allow an overall reduction in consumption of red blood cell units.      Several meta-analyzes reported in intensive care or bleeding situations that a restrictive     use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and     mortality. The number of patient to be treated to prevent one death is 33.      The main objective is to demonstrate in a randomized trial that the restrictive strategy     (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy     (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are     performed in case of hemoglobin level <8g/dL.      Key secondary objectives are to reduce the number of RBP used and the cost of hospitalization     with a comparison of complications/mortality in the 2 groups.   "
62983|NCT02461251|"     This is a prospective, randomized and controlled study to find out if a rotational     thromboelastometry(ROTEM) guided treatment protocol reduces the need for blood transfusions     in major obstetric haemorrhage compared to standard care of clinical decision making,     conventional coagulation tests and massive transfusion protocol. Secondary aim is to find out     if ROTEM can predict the incidence of thromboembolic events in this patient group.   "
62984|NCT02461238|"     The purpose of this study is to assess whether fruit and vegetables vouchers combined with     educational support may increase fruits and vegetables consumption of children aged 3 to 10     living in vulnerable families in Saint-Denis, France.   "
62985|NCT02461212|"     The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in     a MRI) can accurately detect the amount of fat in the liver.   "
62986|NCT02461199|"     During this prospective observational study, the investigators collect the information about     the outcomes of fecal microbiota transplantation in patients with blood disorders, performed     to eradicate gut colonization with multidrug-resistant (MDR) bacteria.      Patients with blood disorders are characterized by poor diversity of gut microbiome, affected     by repeated chemotherapy and antimicrobial treatments. This makes them vulnerable to     colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance. In     case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause     severe systemic infections. As the bacteria are secreted with the stool, the colonized     patients become an epidemiologic threat to the others.      Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of     relapsed and refractory Clostridium difficile infection and became a standard treatment. In     home institution, the investigators use FMT not only in case of Clostridium difficile     colitis, but also in case of gut colonization with multidrug-resistant (MDR) bacteria. This     is based on assumption that physiological gut flora may outcompete the pathogenic bacteria     similarly as in case of Clostridium difficile and lead to loss of colonization. The procedure     is performed in all patients colonized, who qualify according to listed inclusion and     exclusion criteria .   "
63003|NCT02460978|"     The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and     effective therapy to improve glycemic control in patients with type 1 diabetes.   "
63279|NCT02457572|"     Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid     responsiveness. However, its usefulness in open-chest conditions has been equivocal. The     investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid     responsiveness after sternotomy.   "
62987|NCT02461186|"     Emerging resistance to artemisinins and their partner drugs severely threatens the treatment     of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug     policy, it is crucial to evaluate alternative antimalarial treatments.      The investigators here propose a randomized clinical trial comparing parasite clearance     parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days     dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria     in Myanmar stratified for the presence of K13 mutation in the infecting parasite strains.   "
62988|NCT02461173|"     Four hundred and fifty women with unexplained infertility will be divided into 3 equal groups     using computer generated random numbers: Group 1 will have up to 4 stimulated IUI cycles,     group 2 will have up to 4 unstimulated cycles, women who do not become pregnant after the 4     cycles in groups 1 and 2 will be advised to have regular intercourse at the expected time of     ovulation. Group 3 will be the control group will be advised to have regular sexual     intercourse at the time of ovulation for 6 months   "
62989|NCT02461160|"     The purpose of this study is to characterize the safety, tolerability and plasma     pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral     suspension doses at escalating dose levels in healthy participants, including elderly     participants.   "
62990|NCT02461147|"     Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has     been implemented at the investigators institution as the standard management strategy for     patients at intermediate risk of common bile duct stone migration, following a randomized     controlled trial previously published by the same investigators team. The aim of this study     is to prospectively analyze the outcomes of this strategy.   "
62991|NCT02461134|"     Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person     (the host) who has received cells or organs (graft) from another person because the graft     attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the     USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes     (a type of white blood cells) are likely to play a role in the development of chronic GVHD.     Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a     new therapeutic approach to treat chroninc GVHD.      The main objective of this study is to assess the effectiveness and safety of several doses     of ponesimod in subjects with chronic GVHD who did not respond to standard available     treatments.   "
87655|NCT02138721|"     The objective of this study is to evaluate the role of local treatment with radical     prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.   "
62994|NCT02461095|"     Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower     extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been     identified as an important factor in patients with PFPS. The authors hypothesize that an     ordered approach addressing each of these impairments sequentially will result in greater     improvement in PFPS symptoms. The results of the investigators pilot study assessing the     feasibility of using a sequential approach showed a full randomized controlled trial is     warranted, the authors now plan to proceed with a full trial. The objective of this study is     to assess the efficacy of a sequential approach in the treatment of Patellofemoral Pain     Syndrome.      Methods: Patients will be randomized to a sequential treatment approach using a PFPS     treatment algorithm (PFPS Algorithm) designed by the authors or typical physical therapy     care. Due to the constant evaluation necessary no blinding will be performed. Patients will     attend therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and     Global Rating of Change (GROC) will be measured at evaluation and discharge, 3 month     follow-up and 6 month follow-up.   "
62995|NCT02461082|"     The purpose of the study is to examine the effectiveness of different methods for the     treatment of dysphagia in Parkinson's disease (PD). More than 80% of patients suffering from     PD develop dysphagia during the course of their disease leading to malnutrition, loss of life     quality, weight loss and pneumonia, which is the leading cause of death in these patients. So     far, only a few specific treatment approaches have been investigated in PD patients with     swallowing disorders. The investigator want to compare a 4-week expiratory muscle strength     training (EMST), transcranial magnetic stimulation (TMS), and combination of both with a sham     therapy. Dysphagia severity before and after intervention is measured by flexible endoscopic     evaluation of swallowing (FEES). For the evaluation of changes in cortical swallowing     processing the investigators apply magnetoencephalography (MEG).   "
62996|NCT02461069|"     This is an exploratory study, which allows analysis of multiple immune parameters derived     from peripheral blood mononuclear cells (PBMCs) from patients with relapsing remitting     multiple sclerosis before and during immune-modulatory treatment with dimethyl fumarate in     comparison to PBMCs from healthy subjects.   "
62997|NCT02461056|"     Intravenous form of ibuprofen is recently approved by FDA and reports are rare on the     co-administration with opioids. The investigators searched whether intravenous     ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on     postoperative pain using combination index (CI), dose reduction index (DRI) and isobologram.   "
62998|NCT02461043|"     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.        -  Five year survival rate after radical esophagectomy is modest at about 40%.The patients          with regional lymph node metastases have worse outcome than those without lymph node          metastases.        -  No standard postoperative adjuvant chemotherapy has ever been established.   "
62999|NCT02461030|"     This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of     dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a     period of 8 weeks.   "
63000|NCT02461017|"     The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed     assessment to verify appropriate tube size in neonates, infants and children. However, many     factors are known to influence the audible leak test. Even though the test is widely     performed, the accuracy has not been evaluated.   "
63004|NCT02460965|"     Rationale: Hallucinations occur in many patients with different kinds of diseases, including     psychiatric, neurological and perceptual impairment. The origin of these hallucinations is     only partly understood. This prevents correct prediction of treatment response and hampers     the development of new, more effective treatment strategies.      Different subtypes of hallucinations resulting from different neuropathology may exist across     diagnostic entities, and be responsive to different treatment strategies. Understanding the     origin of these subtypes with use of fMRI and EEG can help to make rational treatment     decisions on an individual basis and enhance the development of innovative treatment     paradigms.      Objective: The primary objective is to find specific abnormalities on resting state fMRI     related to the pathophysiology of different subtypes of hallucinations. Secondary objectives     are to find EEG connectivity measures that are related to the pathophysiology of different     subtypes of hallucinations, reveal correlating patterns of EEG and fMRI that underlie the     experience of hallucinations across different disorders, and to examine the frequency of     spontaneous synchronized burst activations in auditory and visual cortices using fMRI.      Study design: The investigators intend to examine neural correlates of hallucinations over     different disorders using resting state EEG, fMRI and sMRI in an observational study.      Study population: A total of 140 hallucinating patients will be included, 20 of each of the 7     different diagnostic groups. As a control group, 140 non-hallucinating patients with the same     disorder of similar severity will be included.      Main study parameters/endpoints: The main study endpoint is the difference in resting state     correlates as measured with fMRI between hallucinating and non-hallucinating participants and     between hallucinating individuals of different subtypes, namely: connectivity within the DMN     and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Participation in the study will entail an MRI scan of 40 minutes and an EEG     measurement of 5 minutes. Total visit time, including preparations, will be approximately 2,5     hours. The risks associated with participation and the benefits to the individuals are     negligible. The potential benefit to society in the future is considerable if the findings     lead to optimization of treatment strategies and treatment response.   "
63005|NCT02460952|"     The purpose of this study is to investigate the prevention of Pulmonary Embolism in Patients     who With General Anesthesia Operation in Perioperative Period.   "
63006|NCT02460939|"     The purpose of this study is to investigate the changes of the pulmonary vessel disease and     its metabolism of small molecules.   "
63007|NCT02460926|"     This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment     performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of     periodontal disease. The primary aim was to compare the differences in CRP acute increase     following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included     changes in a broad array of inflammatory and endothelial injury markers between groups.     Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical     periodontal therapy performed within 24 hours induced greater perturbations of systemic     inflammation compared to conventional treatment.   "
63008|NCT02460913|"     Inadequate pain management is a common problem encountered in ED settings. Pain relief     medications use is often limited by their side effects. Evidence suggests that non     pharmacologic pain relief techniques such as acupuncture can play a central role to treat     pain in acute conditions, but their application is still scarce.   "
63009|NCT02460900|"     The single greatest health behavior change that could improve cardiovascular morbidity and     associated mortality is to assist people living with HIV/AIDS who smoke to quit. The     investigators will use a factorial design to evaluate the most promising behavioral and     pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among     people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world     evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit     smoking.   "
63010|NCT02460887|"     The purpose of this study is to verify that induction gemcitabine and cisplatin plus     intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus     IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).   "
63011|NCT02460874|"     Primary Objectives:      Pilot Portion: To determine the feasibility and safety of administering oral glyburide to     non-diabetic patients receiving stereotactic radiosurgery (SRS) for newly diagnosed brain     metastases.      Randomized Portion: To determine the number of patients with newly diagnosed brain metastases     who have an increase in edema as measured on volumetric FLAIR imaging and the number of     patients that require dexamethasone administration (or any corticosteroid administration with     the purpose of treating cerebral edema) from the day of SRS to one month follow-up MRI in the     group receiving glyburide versus placebo.   "
63012|NCT02460861|"     This project is about the detection of occult tumor cells in surgical margins of radical     prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1     (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic     fossa. The biopsies are divided into two parts. One part used for histopathological analysis     and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor     stage, Gleason Score and prostate specific antigen (PSA).      The prostate-cancer-negative control group with bladder cancer.   "
63013|NCT02460848|"     Cash transfer, aims to strengthen food security for vulnerable households by giving families     enough purchasing power to consume an adequate and balanced diet, maintain a good standard of     hygiene, access health services, and invest in their own means of food production in addition     to their children's growth and development.      While cash transfer to vulnerable households has shown a long-term positive impact on growth     and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive     evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on     the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will     perform a cluster-randomized trial to investigate during 6 months the effects of     unconditional cash transfers on the management of severe acute malnutrition (SAM) in children     from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.   "
63014|NCT02460835|"     This is a pilot single arm study with the primary endpoints of feasibility and preliminary     estimates of safety and efficacy. This protocol builds on over 25 years of experience with     high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the     global radiation dose based on a patient's measured sensitivity to treatment. This current     protocol uses functional imaging and specialized radiation planning techniques to spare     highly functional portions of the liver to preserve function. The investigators feel this     will further improve the safety and efficacy of RT for all patients by customizing treatments     to each. If this approach is promising, the investigators will proceed to a phase II     randomized study of standard versus spatially and dosimetrically adapted RT.   "
63144|NCT02459145|"     The general consensus in sports medicine demonstrates a graduated return to activity protocol     for individuals with post-concussion syndrome. This is commonly practiced but there is     insufficient literature to indicate evidence-based practice. This study will provide evidence     of the effectiveness of the clinical gradual return to exercise protocols beginning after     diagnosis of post-concussion syndrome through standardization and measurement of outcomes.   "
63015|NCT02460822|"     This research project addresses critical gaps in cancer symptom management through the     creation of a mobile chemotherapy symptom management application. This application will     assess for the presence and severity of common chemotherapy side-effects and provide     personally tailored symptom-related video and narratives to enhance self-management of cancer     and treatment-related symptoms. This study will examine patient acceptance and use of this     mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who     are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive     Cancer Center.   "
63016|NCT02460809|"     This study assesses telerehabilitation in people with chronic stroke using a combination of     noninvasive brain stimulation and finger tracking training. Telerehabilitation allows     patients to train in their own home which also allows for longer training periods than what     is currently allowed clinically. Noninvasive transcranial direct current stimulation (tDCS)     uses two surface electrodes connected to a small battery that will be attached to the head.     This will be used to modulate neuronal excitability. With sensors attached to fingers and the     wrist, the patient will move the joints to track a target displayed on a screen. The combined     treatment will be applied in two experiments. The first will be on 3 patients coming to our     lab and the second on 3 patients in their home, both under supervision. We will integrate the     two components and test the resulting and novel treatment system for technical feasibility     and safety, which will set the stage for future efficacy studies under federal grant support.     We hypothesize that the developed system will be safe and feasible.   "
63017|NCT02460796|"     BACKGROUND: Motor symptoms associated with Parkinson's disease may impair one's independence     and ability to perform daily activities consequently decreases quality of life. Hippotherapy     has been shown as an effective treatment to improve function in daily activities and quality     of life in other neurological populations, thus a study was conducted to assess the effects     of hippotherapy in people with Parkinson's disease.      METHODS: Nine volunteers formed the treatment group which participated in a ten-week     hippotherapy program, and nine individuals formed the control group (attended a ten-week     series of lessons on Parkinson's disease). Outcome measures included 30-second chair stand     (as a measure of strength-endurance), gait velocity (during 10m walk test) and health-related     quality of life.   "
63040|NCT02460497|"     The purpose of this study is to characterize the effect of Minoxidil 2% Solution and     Botanical Hair Solution Regimen in women with thinning hair and female pattern hair     loss/androgenic alopecia (Ludwig I and II).   "
63041|NCT02460484|"     Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to     children who have suffered from a Perinatal Arterial Ischemic Stroke. The aim is to determine     if hUCB infusion is safe, if late functional outcome is improved, if hUCB treatment improves     physiologic response in the child's SSEP & EEG, and the effect of hUCB infusion in altering     anatomic findings on MRI.   "
63018|NCT02460783|"     Background:      - Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells     may not respond to insulin normally. It can lead to serious diseases. Researchers want to see     how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s     disease.      Objectives:      - To compare two forms of diet and their effects on insulin resistance and the brain.      Eligibility:      - Women ages 55 70 with insulin resistance.      Design:        -  This study requires 6 clinic visits over 9 12 weeks. Participants must fast before          visits.        -  Visit 1, screening:        -  Medical history, physical exam, and blood and urine tests.        -  Participants will get a wrist device to wear for 4 days.        -  Visit 2:        -  Weight and waist measurement.        -  Blood drawn.        -  Questionnaires and thinking tests.        -  Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back          will remove <TAB>fluid.        -  Participants will drink a nutrition shake. Blood will be taken 12 times over 4          <TAB>hours through a thin tube in <TAB>the arm.        -  Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a          strong magnetic field. <TAB>They will have a coil on their head and may do tasks.        -  Participants will get advice about healthy eating and be randomly put in one of 2          groups. One group will get <TAB>nutrition shakes to drink.        -  Visits 3 5:        -  Weight and waist measurements, vital signs, blood draw, and questionnaires.        -  Between visits, participants will get a call or email to check how they are doing.        -  Visit 6: Repeat of visit 1.        -  Participants will wear the wrist device for 4 more days, have a follow-up contact, then          the study is finished.   "
63019|NCT02460770|"     Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to     transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy     and Left Ventricular Assist Device program is to improve heart function with stem cell     therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.   "
63020|NCT02460757|"     In this study the investigators examine the glottic width and the respiratory flow at rest in     patients with various lung disease. The investigators postulated that a positive expiratory     pressure is created through the narrowing of the glottic width in patients with     hyperinflation.   "
63021|NCT02460744|"     The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose     of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast     conservation in breast cancer patients for the last 4 decades. It is also a routine practice     in UK and few centers in Canada. Hypofractionation reduces treatment time to half while     maintaining cosmesis and gives control rates equal to conventional fractionation. As breast     cancer is a leading cancer in females and radiation therapy is an important part of its local     management, hypofractionation help the radiation centers worldwide to meet the growing need     for radiation in breast cancer, particularly in developing countries where resources are     limited. It also reduces the financial burden on the patient and family.      In this study the investigators want to reduce the treatment duration from 3 weeks to 2     weeks. The study will include 20 patients with breast cancer post mastectomy or after breast     conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2     weeks. Patients will be assessed for acute radiation toxicity weekly during treatment and     after one month of completion of treatment.   "
63022|NCT02460731|"     This is a phase 1, multi-center, open-label study of the safety, tolerability,     pharmacodynamics, and preliminary efficacy of young (<30 years of age) healthy male donor     plasma transfusions in patients with PSP. Up to 10 subjects will receive once monthly 4-unit     transfusions of young healthy male donor plasma for 6 months.   "
63023|NCT02460718|"     It is unclear whether peer coaching is effective in minority populations living with diabetes     in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an     innovative peer coaching intervention plus brief education vs. brief education alone on     diabetes outcomes.   "
63280|NCT02457351|"     To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of     roniciclib in cancer patients.      To assess safety and tolerability of roniciclib dosing when administered with and without     itraconazole in cancer patients   "
63024|NCT02460705|"     Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental     treatment of patients with Crohn's Disease stopped for a safety evaluation.      This is a prospective, open label pilot study in which patients with symptoms of Inflammatory     bowel disease will receive FMT therapy delivered via colonoscopy.      The investigators hypothesize that FMT is a safe and effective treatment for patients with     inflammatory bowel disease. The aims are:        1. To determine if symptoms of inflammatory bowel disease can be successfully treated by          Fecal Microbial Transplantation.        2. To determine if endoscopic appearance of colon or ileum improves following treatment by          Fecal Microbial Transplantation.   "
63025|NCT02460692|"     This study will involve treating low back pain associated with nerve injury with oral     delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research     subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or     placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol     and vaporized 3.7% Δ9-THC/5.6% CBD .   "
63026|NCT02460679|"     Open label study with EPI-589 and ALS subjects   "
63027|NCT02460666|"     The purpose of this study is to evaluate the effects after 6 months of supervised weekly     Tai-Chi-Chi versus Health Education and Wellness classes on reduction of depressive symptoms     and improvement in resilience, health functioning, quality of life, cognition, sleep, fMRI     neural correlates of working memory, and brain structure.   "
63028|NCT02460653|"     1. To determine the lowest nasal cannula flow rate in which upper airway deadspace is          reduced. Hypothesis - The lowest flow rate of high flow nasal cannula (HFNC) will reduce          upper airway (extrathoracic) deadspace and improve respiratory efficiency by reducing          transcutaneous CO2 and/or lower respiratory rate.        2. To determine the lowest nasal cannula flow rate in which regional distribution (as          defined by EIT) of ventilation changes. Hypothesis - Moderate to high flow rates will          create positive pressure that leads to improved regional distribution of ventilation.   "
63029|NCT02460640|"     Single-center study in order to assess whether the tap block can make extremely beneficial in     terms of reducing the acute and chronic pain as well as for use of opioids and side effects     related to it in patients undergoing surgery to minimally invasive partial nephrectomy.   "
63030|NCT02460627|"     More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the     knee. Walking function and physical activities are affected by this intensive pain although     local anaesthetic is given in the joint and soft tissue.      The patients are often discharged on the same day as the arthroscopy takes place depending on     their ability to walk with or without assistive technology.      It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice     pack on a painful knee to reduce pain intensity. The aim of the project is to study whether     pain intensity and analgesics can be additionally reduced by giving local anaesthetic by     means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice     pack on a painful knee.      The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus     sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous     fold removed surgically.      This study is planned to be a pilot study in order to complete a future large medical science     study.   "
63031|NCT02460614|"     The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal     clearance with nasopharyngeal aspiration in children admitted with acute viral bronchiolitis.     The investigators selected children, up to 12 months old, admitted for acute viral     bronchiolitis. Patients were divided in aspiration group (AG), submitted to nasopharyngeal     aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance with     physiological solution (0.9%) instillation (RRC) technique. In both groups children were     evaluated three times in the same day in order to verify cardiorespiratory parameters,     clinical score of respiratory dysfunction and adverse effects.   "
63032|NCT02460601|"     The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients     with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of     functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.   "
63033|NCT02460588|"     Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an     annual incidence between 5 and 10% and is responsible for the death of one third of IPF     patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality     at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but     the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by     retrospective series and needs to be confirmed. This confirmation is mandatory to improve     prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with     immunosuppressor in stable IPF.   "
63034|NCT02460575|"     Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus     reuteri DSM 17938 given for five successive days in healthy children. Sixty children will     receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for     safety outcomes.   "
63035|NCT02460562|"     The purpose of this study is to determine whether a novel material of S-PRG fillers     containing in a daily-used resin denture base and their capability of fluoride release and     recharge to elevate the salivary fluoride level and prevent dental caries in Thai middle-aged     patients between 35-60 years of age who wear the resin denture.   "
63036|NCT02460549|"     The purpose of the study is to build and assess the feasibility of a therapeutic education     program, constructed in collaboration with the urologists of the University Hospital of Saint     Etienne. The aim of this therapeutic education program is to delay the onset or to reduce the     amplitude of the development of insulin resistance and side effects of androgen deprivation     therapy in patients treated with androgen deprivation in the context of an evolutive prostate     cancer.   "
63048|NCT02460393|"     This study is a randomized, double-blind and placebo-controlled trial with healthy subjects.     There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12     people. A single subcutaneous injection will be administrated starting from the low dose     group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously).     Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and     pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects     will be evaluated.   "
63037|NCT02460536|"     Attention biases in threat processing have been assigned a prominent role in the etiology and     maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes     computer-based protocols to implicitly modify biased attentional patterns in anxious     patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious     10-18 year-olds. Participants will be assessed using clinical interviews and parent- and     self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control     groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and     depression as measured by gold standard questionnaires as well as structured clinical     interviews with youth and their parents. Attentional threat bias, Attentional control and     interpretation of ambiguous information will also be measured to explore potential mediators     of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to     treatments for anxious children and to provide initial information on mechanisms of ABMT     efficacy.   "
63038|NCT02460523|"     Evaluation of the best line of treatment of borderline CBD stones associated with gallbladder     stones whether by conservative treatment or endoscopic stone extraction as regard complete     clearance rate of the CBD stones followed by laparoscopic cholecystectomy. The secondary     outcomes are overall complications related to each approach, technical difficulties and     conversion rate during laparoscopic cholecystectomy and cost benefit relationship of each     line of treatment.   "
63039|NCT02460510|"     Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation.     Information would be collected regarding the onset and duration of symptoms, etiology, and     severity of disease, other baseline clinical features, demographic characteristics, routine     biochemical and hematological investigations. Patients would also be screened for the     assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD     (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found     to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the     study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where     as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate     of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of     144-155 mmol/L .Both the groups would receive other supportive measures such as head end     elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard     medical treatment.   "
63042|NCT02460471|"     Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity     Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of     life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.   "
63043|NCT02460458|"     A 5 - year International Registries and Prospective Study on VWD Type 3, aimed to assess     number, types and risk factors for bleeding and the efficacy and safety of VWF concentrates     used to treat VWD patients .   "
63044|NCT02460445|"     AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting     on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk     factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic     hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to     usual clinical practice.      METHODOLOGY      Open label, controlled, parallel, prospective study of 12 months of duration, with 2     randomized arms of follow-up:      i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment     randomly allocated to perform scheduled phlebotomies from the third month of treatment to the     end of the study (3 times with a 3-month interval between them).      ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment     randomly allocated to follow-up without bloodletting.      The whole group of patients will undergo a comprehensive anthropometric and hormonal     assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and     carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory     and office blood pressure monitoring, proinflammatory profile, oxidative stress status,     autonomic function assessment, and iron-related metabolism parameters at baseline, after     3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention     Group of patients, and throughout follow-up under treatment with COC in the Control Group of     patients. If a significant relationship between circulating hepcidin levels and elevated     ferritin concentrations is observed, a study of the potential influence of     mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.   "
63045|NCT02460432|"     The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III     Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary     obstruction.   "
63046|NCT02460419|"     This multicenter, randomised, phase 3 study is to evaluate the survival benefit of     maintenance capecitabine plus best supportive care versus best supportive care for metastatic     nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.   "
63047|NCT02460406|"     This study is aimed to investigate effectiveness of progressive functional strength training     protocol (functional squat system with virtual reality in leg press, plyometric exercises,     exercises with Bosu ball & heel-rise exercises) on Body Functions and activity in children     with unilateral spastic Cerebral Palsy (CP) by applying current guidelines. According to     literature, there are studies that investigate the effects of functional strength training in     children with CP. But there is no randomized controlled trial, explore the effects of     progressive functional strength training protocol on body functions and activity on     unilateral spastic CP. Hypothesis of this study is that progressive functional strength     training protocol improves performance-related physical fitness, gross motor function,     dynamic, balance, muscle tone and muscle strength in unilateral spastic CP.   "
63049|NCT02460380|"     Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is     characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction,     hirsutism and infertility. Although the pathogenesis of PCOS is unknown, accumulating     evidence suggests that transforming growth factor-β (TGF-β) dysregulation may be implicated.     TGF-β is the prototype member of the TGF-β superfamily of proteins. TGF-βs exert a diverse     range of biological functions regulating cell proliferation, angiogenesis, fibroblast     activation and tissue fibrosis. PCOS ovaries show all the hallmarks of TGF-β upregulation,     including increased collagen deposition in ovarian stroma and theca, supported by increased     vascularity. Consistent with this, The investigators recently showed that TGF-β1 is increased     in serum of PCOS women while its circulating receptor soluble endoglin (sENG) is decreased,     resulting in greater TGF-β1 bioavailability. PCOS patients also have decreased vitamin D     levels, and vitamin D treatment has been previously shown to improve various clinical     parameters in PCOS women, including glucose intolerance, hypertension and androgen levels.     Interestingly, vitamin D has been shown to decrease TGF-β1 levels in several diseases where     TGF-β1 is elevated, including myelofibrosis. Therefore, the investigators hypothesize that     vitamin D treatment of PCOS women will result in a decrease of serum TGF-β1 levels     concomitant with improvement in clinical disease parameters. In addition, the investigators     hypothesize that improvement in clinical disease parameters will correlate with changes in     TGF-β1 bioavailability. Our aim in the present study is to investigate the effects of vitamin     D treatment on serum TGF-β1/sENG levels in PCOS women, and assess whether changes in     TGF-β1/sENG levels following vitamin D treatment correlate with clinical disease in these     women. For this end, PCOS patients who are vitamin D-deficient will be treated with vitamin D     and their serum levels of TGF-β1 and its sENG receptor will be measured before and after     treatment. In addition, clinical disease parameters will be recorded before and 4 months     after treatment, including serum glucose and insulin levels, serum androgen levels, and blood     pressure.      The proposed study aims to identify a putative link between vitamin D and TGF-β1 in the     context of PCOS, and provide a novel molecular explanation for the beneficial clinical     effects of vitamin D on PCOS patients.   "
63050|NCT02460367|"     This is a Phase 1/2 trial using indoximod, an inhibitor of the immune checkpoint pathway     indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and     Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). From a     practical standpoint, a successful tumor immunotherapy will likely require a combination     treatment with additional therapeutic interventions that both activate an immune response and     remove redundant mechanisms of tolerance maintenance. This clinical trial utilizes the     combination of the chemotherapeutic agent, docetaxel, plus two investigational methods of     cancer immunotherapy: the first, tergenpumatucel-L, is intended to educate the human immune     system to recognize the abnormal components found in lung cancer cells, resulting in an     immune response intended to destroy or block the growth of the cancer; and the second, the     IDO inhibitor Indoximod, will overcome tumor-induced immune suppression.      The goal of this study is to assess the progression-free survival (PFS) and overall survival     (OS) rates in this patient population. This study will provide a foundation for future trials     testing indoximod combined with tergenpumatucel-L.   "
63051|NCT02460354|"     The purpose of this study is to determine whether metformin can increase urine concentration     (osmolality) and decrease the amount of urine in patients with congenital nephrogenic     diabetes insipidus (NDI).   "
63052|NCT02460341|"     This project investigates the effects of a single dose of ondansetron on brain function in     healthy adults. The investigators hypothesize that there will be a dose-dependent reduction     in activation of the insula and somatosensory brain regions associated with the use of     ondansetron.   "
63053|NCT02460328|"     -  Evaluate about age of resolution in immune defect in 22q11.2 Deletion Syndrome        -  Incidence of immunodeficiencies in 22q11.2 Deletion Syndrome   "
63054|NCT02460315|"     Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD)     stones. However CBD stones can also be formed in the absence of gallbladder stones. The     current standard of treatment for calcular obstructive jaundice is endoscopic removal of the     stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for     patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval     between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from     days to months. Some retrospective and other prospective studies have investigated this issue     without sharp clue or definite conclusion This study planned to compare early LC (within     admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and     surgical outcomes.   "
63055|NCT02460302|"     Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by     dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic     vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally, local     estrogens have been used to treat atrophic vaginitis      Studies have shown that there are progesterone receptors in vaginal tissues. The use of     progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been     studied in other populations including as a fertility medication in pregnant women.      There is a significant group of women who cannot use, choose not to use, or do not respond to     estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal     progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a     randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the     treatment options for patients with symptoms of vaginal atrophy.   "
63056|NCT02460289|"     The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical     Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic     alopecia (Norwood III & IV).   "
63057|NCT02460276|"     In this trial, patients with mantle cell lymphoma will be included, treatment with     lenalidomide, rituximab and ibrutinib will be administered in an induction phase for up to 12     cycles, cycle length 28 days. Patients with complete remission, partial response or stable     disease will enter a maintenance phase with treatment with ibrutinib and rituximab until     progression of disease.      The primary objective is to evaluate overall response rate, based on PET and CT.   "
63058|NCT02460263|"     The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by     trained individuals and In-Home by trained Subjects.   "
63072|NCT02460081|"     Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind,     placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU)     with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects. This     study will investigate the hemodynamic effects, clinical efficacy, and safety of 3 monthly     intramuscular (IM) injections of PDA-002 in subjects who have DFU with PAD.   "
63073|NCT02460068|"     This Phase 3, open-label, triple arm study aims to evaluate the overall survival (OS) of     fotemustine versus the combination of ipilimumab and fotemustine or the combination of     Ipilimumab and nivolumab in patients with metastatic melanoma with brain metastasis.   "
63281|NCT02457338|"     The purpose of this study is to determine if supplementing healthy term infants delivered by     C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive     days increases levels of bacteria in infants' stool.   "
63059|NCT02460250|"     According to the French Biomedicine Agency annual report on retrieval activities and     transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount     of brain death donors and retrieved liver grafts appears relatively stable, it remains     clearly insufficient compared to the increasing number of patients on the waiting list for     liver transplantation (2,462 in 2011). The median time on the waiting list before liver     transplantation which was established from the cohort of patients registered between 2007 and     2011 (excluding patients registered for emergency transplantation and for living     related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009     to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts,     donors acceptance criteria were broadened. For example, alternative transplantation lists     were created with liver grafts coming from so-called marginal donors. However, despite     these efforts, livers were retrieved on only two out of three brain death donors, i.e. in     1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough     to meet the increasing needs in liver grafts and a growing number of patients wait each year     for transplant. Strategic lines of improvement were defined in order to meet the 2012-2016     transplant perspective which targets 5,700 transplants carried out in 2015 (+5% every year,     all transplants included, with 5,023 transplants in 2012).      According to the last consensus conference on liver transplantation of the HAS (French High     Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar     steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists     in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16%     to 31% in the general population, and increases up to 46% in heavy drinkers and to 50-80% in     the obese population. Steatosis results mostly from alcohol consumption and from metabolic     syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic fatty liver     disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to certain     medications. NAFLD involves up to 30% of the population in Western countries and its     prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to     steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly,     the improvement of liver grafts selection based on objective quantitative criteria which     takes into account the degree of liver steatosis appears crucial to increase the number of     hepatic transplants.   "
63060|NCT02460237|"     This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test     intervention among women from Ohio Appalachia in order to determine the feasibility of HPV     self-testing as a potential cervical cancer screening strategy. The intervention group will     receive culturally appropriate materials and the control group will receive standard     materials with their HPV self-test device.   "
63061|NCT02460224|"     This study is to characterize the safety, tolerability, pharmacokinetics (PK),     pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination     with PDR001 to adult patients with solid tumors. The study consists of a dose escalation     phase (I) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D)     for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II)     which will characterize treatment of LAG525 as a single agent and in combination with PDR001     at the MTD or RP2D.   "
63082|NCT02459951|"     Relevant to patients with spastic hemiparesis in the hand and upper limb, this pilot project     proposes to measure the effects of botulinum toxin injections through observation of     performance on a functional task known as 'hand as a holder'. This task requires the person     with hemiplegia to insert an object into the affected hand and hold it independently.      The project aims to demonstrate reliability and validity of a digital video method that will     be used to measure 'insertion time'. It also aims to establish initial statistical support     for improved object insertion time into the hemiplegic clenched fist after Botox A     injections.   "
63062|NCT02460211|"     Each patient who is admitted for preoperative preparation for elective open heart surgery at     Intermountain Medical Center will be invited to participate in this study. After a written     informed consent is obtained, patients meeting inclusion/exclusion criteria will be     randomized 1:1 to the treatment arm or placebo/control arm. Those randomized to the treatment     arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The first dose     will be given the evening before surgery. The second and third doses will be given either     orally or per NG tube on the mornings of post-op days 1 and 2. Blood will be obtained at the     following time periods: 1) At baseline pre-procedure 12 to 18 hours before planned surgery;     2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours     after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At     the 6-month follow-up visit (post-surgery). Plasma levels of 25(OH) vitamin D will be     measured on each sample.   "
63063|NCT02460198|"     In this study, participants with previously-treated locally-advanced unresectable or     metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high     colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®)     monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A,     participants are required to have been previously treated with standard therapies, which must     include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been     completed. For Cohort B, participants are required to have been previously treated with at     least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or     fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal     growth factor regulator (EGFR) monoclonal antibody.   "
63064|NCT02460185|"     Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy     as a method to enhance spontaneous labor.   "
63065|NCT02460172|"     Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for     wound closure following bi lateral knee replacement surgery.   "
63066|NCT02460159|"     This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin     (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants     with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up     to 20 mg. There is no formal hypothesis for the study.   "
63067|NCT02460146|"     The main purpose of this trial is to demonstrate the safety, tolerability and     pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral     doses over 14 days to healthy obese male volunteers.   "
63068|NCT02460133|"     This pilot study is crucial to determining whether treating individuals who are at high risk     for transmission or re-infection will impact HCV reinfection rates. It will establish the     feasibility of DAA treatment in corrections facilities, as well as delineate the underlying     immune basis of HCV cure and reinfection.   "
63069|NCT02460120|"     The Archimedes System is an image-guided navigation system used to access tissue samples in     the lungs. This study is being conducted to confirm the performance of the Archimedes System     in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung     cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor     is conducted.   "
63070|NCT02460107|"     The purpose of this study is to determine whether botulinum toxin A is effective in the     treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.   "
63071|NCT02460094|"     The purpose of this study is to evaluate the safety and tolerability of multiple ascending     intravenous infusions of BMS-986168 and to assess the pharmacodynamics of BMS-986168 on     cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in patients with     Progressive Supranuclear Palsy.   "
63145|NCT02459132|"     This study evaluates the impact of a supervised 12-week high-intensity aerobic interval     exercise program (versus a self-directed exercise usual care group) on traditional and novel     cardiovascular disease risk factors and surrogate markers of cardiovascular- and     overall-mortality in a population-based sample of testicular cancer survivors.   "
63074|NCT02460055|"     The purpose of this study is to conduct a randomized clinical trial to compare the incidence     of dysphagia in patients receiving general anesthesia with and without an endotracheal tube     for Upper gastrointestinal endoscopy. If the incidence of dysphagia is found to be increased     following endotracheal intubation for this procedure it could influence the investigators     practice as anesthesiologists and may mandate the future routine use of laryngeal tracheal     application of lidocaine at the time of intubation for example.   "
63075|NCT02460042|"     The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon     catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries.     It is the intention of this trial to treat suitable target lesions with drug coated balloon     (DCB) only.   "
63076|NCT02460029|"     The aim of this study is the visualization of the mesh surface and the confirmation with MRI     scan at 1 month and 13 months after standardized retromuscular incisional hernia repair with     the visible CICAT mesh (Dynamesh®).   "
63077|NCT02460016|"     This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect     of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).   "
63078|NCT02460003|"     This study evaluates the effectiveness of physiotherapy program in the treatment of cluster     headaches. Half of participants will receive a program of physiotherapy and usual drugs,     while the other will receive an exercise program and usual drugs.   "
63079|NCT02459990|"     Assess Fetal Mortality and Malformations in Women treated with antihypertensive medication     during preganancy. Mother - Child pairs will be analysed in a cohort selected from the UK in     the CPRD database. Years covered are 1997 to 2014. Aim is to assess the risk of     Antihypertensive treatment in women.   "
63080|NCT02459977|"     Basiliximab has been a routine induction therapeutic agent even for well-matched living     kidney transplantation(KT) with tacrolimus-based immunosuppression in Korea. As tacrolimus is     a different drug from cyclosporine, the investigators study the usefulness of     tacrolimus-based immunosuppression without basiliximab in well matched living KT.   "
63081|NCT02459964|"     The goal of this clinical research study is to compare fentanyl nasal spray with a standard     drug given by vein (hydromorphone hydrochloride) to help reduce pain related to cancer in     patients coming to the emergency department.   "
63084|NCT02459925|"     The MOMS Partnership aims to create MOMS Zones in New Haven neighborhoods where the hardest     to reach families live. These MOMS Zones will have two unique features: (1) a MOMS Hub to     deliver centralized mental health and family economic success services to the hardest to     reach families living in New Haven's most impoverished neighborhoods, as measured by actual     socio-economic status as well as by access to resources; (2) a neighborhood workforce of     Community Mental Health Ambassadors (CMHAs--mothers who themselves live in New Haven). The     MOMS Workforce Program and MOMS Mental Health Program will be offered at all three Hubs.   "
63085|NCT02459912|"     Men with low-risk, clinically localized, unilateral prostate cancer will be treated with     unilateral nerve-sparing cryoablation and evaluated for the rate of potency, cancer control     and health related quality of life outcomes after treatment.   "
63086|NCT02459899|"     The primary objective of this study is to define the dose leading to desirable efficacy, as     measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.   "
63087|NCT02459886|"     The primary objective of the study is to evaluate the safety and tolerability of a range of     single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy     participants and participants with early Parkinson's disease (PD). Secondary objectives of     the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose     administration and to evaluate the immunogenicity of BIIB054 after single-dose     administration.   "
63088|NCT02459873|"     Children with low executive function, working memory and attention skills in childhood not     only do poorly at school, but also go on to do poorly on social, health, and financial     indicators in adulthood.      The rate of executive function disorders in children is vastly underestimated at 17% , even     when taking into account two of the more widely known disorders of Attention Deficit     Hyperactivity Disorder (11%) and Fetal Alcohol Spectrum Disorders (6%), but children of lower     socioeconomic status are especially vulnerable due to reduced resource availability.      As executive function, working memory and attention skills are central to success in later     life, if children with low skills can be given targeted training to improve the skills they     fall short on, there is potential to both improve their short-term academic performance, and     influence long-term achievement. In fact, poor executive function skills and poor attention     and working memory is a large predictor of poor performance even in typically developing     children who are doing poorly academically.      Hypothesis 1. Those with lower working memory will also have lower problem solving skills and     lower indices of other executive functioning skills such as reasoning/problem solving.      Hypothesis 2. Children that start with lower WM and PS will show the highest gains in     training related performance, and such high gains on WM and PS will lead to better     performance post-intervention compared to baseline measures of cognitive function.      Hypothesis 3: Those who make the largest gains in WM and PS with training will show more     retention of training gains at 6 months compared those who show lower gains.      Aim 1. Assess working memory (WM) and processing speed (PS) skills in children and their     inter-relationships with executive functioning skills Aim 2. Examine change in cognitive     function in WM and PS after intensive training in WM and PS, during and immediately     post-intervention Aim 3. Examine long-term retention of training effects on WM, PS, and     executive functions.      The purpose of this study is to establish an effective and targeted working memory and     processing speed intervention in children ages 7-10 with low to average executive function     skills, by utilizing home-based computer games specifically designed to appeal to children.      Following institution approved consents, 60 low socioeconomic status children from Los     Angeles will be recruited and enrolled in the study and be asked to play specific fun, but     targeted cognitive computer games for 10 weeks.      The results of this pilot study will establish a protocol for feasibility of improving     executive function skills in children with underdeveloped skills and inform on sufficiency of     sample sizes, length of interventions, and directly impact computer-based intervention     research and cost-effective techniques in children's cognitive development within the next     3-5 years.   "
63107|NCT02459626|"     StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that     will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right     ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI     is a valid, non-invasive method to assess diastolic function in patients with Heart Failure     with preserved ejection fraction.   "
63089|NCT02459860|"     The purpose of this study is to determine whether individually-administered Problem Solving     Treatment is effective in managing depressive symptomatology in 250 primarily     Spanish-speaking Latino patients ≥55 years of age or older with high medical comorbidity. The     aim is to test if Programa Esperanza improves: a) problem solving skills and behavior     activation; b) depression-related outcomes; and b) physical functioning compared to enhanced     usual care over the course of one year.   "
63090|NCT02459847|"     The objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and     mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain     understanding of patient perceptions, preferences, and experiences with mind-body     interventions.   "
63091|NCT02459834|"     Diabetes remains one of the most important unmet prevention and treatment challenges, and the     prevalence of diabetes continues to grow. Some functional food ingredients may hold promise     as potential therapies for diabetes. One such functional food is allulose, which is a c-3     epimer of fructose. Allulose is a non-caloric sugar found naturally in small amounts in foods     such as dried fruits, brown sugar and maple syrup. Previous research has found that catalytic     doses of fructose and allulose have been shown to decrease the postprandial glycemic     responses to high glycemic index meals. Fructose, in exchange for other carbohydrates, has     also been found to decrease HbA1c levels. Whether the effects of fructose and allulose are     equivalent is of particular interest, as allulose represents a non-caloric alternative to     fructose. The minimum 'catalytic' dose at which improvements in carbohydrate metabolism are     observed also remains to be determined for each of the sugars in people with and without     diabetes. This study is an acute randomized controlled dose-finding equivalence trial to     assess the effect of fructose and allulose at 2 dose levels (5g and 10g) compared with     control (0g) on the glucose and insulin responses to a 75g oral glucose tolerance test (OGTT)     in healthy and type 2 diabetes participants.   "
63092|NCT02459821|"     Multiple sclerosis (MS) is the most common non-traumatic cause of neurologic disability in     young adults,affecting mobility and ambulation in the majority of patients. At least 50% of     individuals with MS will require an assistive device to ambulate within ten years of     diagnosis. Impaired mobility is one of the top three factors associated with inability to     continue working. In addition,impaired mobility and the inability to walk functionally     translate into significant costs for personal assistance, medical complications, and lost     wages because of unemployment. Clearly,maximizing the ability to ambulate, as well as perform     safe and effective transfers,is a fundamental goal in the management of individuals with MS.     None of the currently available MS disease-modifying medications have been shown to stop or     reverse gait disability. Repetitive locomotor training is an innovative approach in gait     disturbances in patients with MS. Only scant data on this issue is available and all the     studies have been performed by means of treadmill training or robot assisted gait training     (RAGT) approaches. The recent introduction of a robotic device to gait rehabilitation showed     a significant improvement in gait ability in patients with neurological disease due to the     possibility of being trained under a graduated body weight support condition and being being     guided to reproduce a physiologic gait pattern.      In 2010 a novel device called GE-O System was developed. It enables patients to repetitively     practice walking on the floor and also climb up and down stairs. To date, the effectiveness     of this novel device has not yet been evaluated in patients with MS. The aims of the study     are as follows: to evaluate the effectiveness of a specific gait training program consisting     of the GE-O System in patients with MS in improving balance and walking ability,reducing     fatigue,the frequency of falls,the fear of falling and disability in activities of daily     living and finally,improving quality of life.   "
63093|NCT02459808|"     Constipation is a common condition among patients with Guillain-Barré Syndrome. It is     believed, that the constipation is caused by autonomic neuropathy. However, the severity of     the constipation, and its relation to autonomic function have not previously been studied.   "
63094|NCT02459795|"     The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an     FDA approved drug in the treatment of actinic keratosis.   "
63095|NCT02459782|"     Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught     the orbit to be successful and has a relatively high failure rate. This study will examine a     novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion     of local anaesthetic by using a dual quadrant injection technique. The study will assess the     feasibility of this technique, how successful it is and whether any obvious safety issues     arise with its use.   "
63096|NCT02459769|"     The purpose of this study is to test preliminary efficacy, as well as acceptability and     feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer     survivors and their non-professional caregivers as dyads to either an individual or a dyadic     Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be     psychological distress. Analyses will involve pre-post comparisons of outcomes across the     study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will     result in greater improvements in psychological distress than an individual intervention.   "
63097|NCT02459756|"     Regular consumption of fruits and vegetables may improve human health and reduce the risk of     chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active     components and the underlying mechanisms are poorly understood. Berry fruits are abundant in     anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich     blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels,     inflammation and platelet function). Further, the study will investigate the anthocyanin     bioavailability from the blackcurrant beverage.   "
63108|NCT02459613|"     Intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology     involving the aggregation of activated platelets with phosphatidylserine (PS) expression on     the outer layer of the thrombus. They also share common complications, i.e. damages to the     underlying myocardium and embolic risk related to thrombus fragmentation. The diagnostic     work-up, currently relying on morphologic imaging alone (mainly echography), lacks     sensitivity and does not allow to differentiate between active (renewal and growth activity)     and quiescent (scarred) thrombus. It is therefore highly desirable to develop a new approach     able to non-invasively provide insight on the biological activity of thrombi and to detect     embolic events in a single exam.      Annexin V is a 36 kDa endogenous glycoprotein which binds PS with nanomolar affinity.     Radiolabeled Annexin V has been shown to provide molecular imaging of PS expressed by     apoptotic cells or activated platelets. The ability of the imaging agent to bind mural     thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex     vivo in human. It has been also shown that radiolabeled Annexin V allowed in vivo detection     of vegetations and secondary pulmonary emboli with high sensitivity in various animal models     of infective endocarditis.      A radiolabeling kit of annexin V complying with GMP requirements has been developed     (rhAnnexine V-128, Advanced Accelerator Applications - Atreus) and is currently available.     AnniE is a single centre, proof of concept, interventional, open, non-randomized study aiming     at evaluating the sensitivity of 99mTc-Annexin V-128 in the detection thrombus in comparison     with reference imaging in patients presenting with either: 1/ infective endocarditis or 2/     atrial thrombus. The safety of the 99mTc-Annexin V-128 will be assessed in a first phase (10     first patients enrolled). Data in relation with safety of the imaging agent will be reviewed     by an independent Data and Safety Monitoring Board (DSMB); in case of positive answer, the     study will continue with a second phase. The data gathered in all patients (n=120) will be     used to determine outcome measures.   "
63098|NCT02459743|"     In this prospective multicentric study, the University of Pavia together with the Fondazione     IRCCS Policlinico San Matteo, Pavia and the IRCCS Fondazione Maugeri, Pavia, Italy will     provide a systematic analysis of gene mutations in hematological malignancies by using NGS     techniques. Patients with a conclusive diagnosis of haematological malignancies according to     WHO criteria referred to the Rete Ematologica Lombarda clinical network (REL,     www.rel-lombardia.net) will be enrolled. The investigators will analyse genomic DNA extracted     from hematopoietic cells at different time points of patient disease. The study contemplates     the use of molecular platforms (Next Generation Sequencing, NGS) aimed at the identification     of recurrent mutations in myeloid and lymphoid neoplasms, respectively. Screening of gene     mutations by NGS will be prospectively implemented in the context of REL clinical network.     Patient samples will be analyzed at diagnosis and sequentially during the course of the     disease at specific timepoints. The researchers will analyze the correlations between somatic     mutations, specific clinical phenotypes (according to the WHO classification) and disease     evolution. This will allow to: 1) identify new recurrent genetic mutations involved in the     molecular pathogenesis of hematological malignancies; 2) define the role of mutated genes,     distinguishing between genes which induce a clonal proliferation of hematopoietic stem cells,     and genes which determine the clinical phenotype of the disease; 3) identify mutations which     are responsible for disease evolution; 4) define the diagnostic/prognostic role of the     identified mutations, and update the current disease classifications and prognostic scores by     including molecular parameters. A systematic biobanking of biological material will be     provided.   "
63099|NCT02459730|"     This study evaluated the clinical and microbiological long-term effects of 1.25% CHX     associated with GIC applied in primary molars using Atraumatic Restorative Treatment (ART)     technique. Randomized controlled trial was conducted on 40 children with carious lesions that     received ART either with GIC containing CHX or GIC only. Survival rate of restorations was     checked at 3 days, 3 months and 1 year after their placement when the unstimulated saliva     samples were collected for microbiological assessment of mutans streptococci (MS) counts.     Data were analyzed using ANOVA/Tukey or Kruskal-Wallis/Mann-Whitney tests (p <0.05).   "
63100|NCT02459717|"     Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom     affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have     been investigated and are now available for the management of constipation in PD. Preliminary     data have suggested that probiotics could be help improving bowel habits but high-quality     randomized trials are required in this area. Therefore, the investigators designed a     randomized trial to evaluate whether the use of a fermented milk containing multiple     probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD     compared to placebo.   "
63101|NCT02459704|"     The aim of this study will be evaluate clinically the use of the Semilunar Coronally     Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel     Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients     will receive EMD associated to SCPF, while the other half, will receive SCPF alone.   "
63102|NCT02459691|"     The purpose of the study is to develop a culturally adapted intervention (CAI) program to     improve weight and physical activity in overweight or obese adult Latinos at high risk for     developing type 2 diabetes and/or cardiovascular disease (CVD) and to rigorously evaluate the     effectiveness and implementation potential of the CAI program.   "
63103|NCT02459678|"     This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to     initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy.     Under a 3-phased research study the investigators will: (1) conduct formative research     regarding readiness to start lifelong ART in the pregnant population; (2) translate the     results of formative research into a readiness assessment tool and an enhanced adherence     package for pregnant women eligible for Option B+ and (3) conduct an individual randomized     trial of the enhanced adherence package.   "
63104|NCT02459665|"     This is a pilot study to prepare for larger clinical trials. Sixty HIV-negative,     non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (BV) by Amsel     criteria and/or Trichomonas vaginalis (TV) on wet mount or by culture will be treated using     oral metronidazole for 7 days. After successful treatment, and when they are free of vaginal     candidiasis, other curable sexually transmitted infections (STIs) and urinary tract infection     (UTI)), they will be randomised to 4 different vaginal microbiome (VMB) maintenance     interventions (15 per group) within 3 days of completing oral metronidazole treatment: 1)     Behavioral 'vaginal practices cessation and safer sex' counselling only (control); 2)     Behavioral counselling plus 500mg metronidazole pills twice per week for two months; 3)     Behavioral counselling plus Ecologic Femi vaginal capsule, once per day for 5 days     immediately after oral metronidazole treatment followed by thrice weekly, for two months; 4)     Group 4: Behavioral counselling plus Gynophilus vaginal tablet, once every 4 days for two     months. In all 3 biomedical intervention groups, vaginal product use may be ceased     temporarily during menstruation. Participants will be asked to adhere to the interventions     for 2 months, and VMB assessments will take place before (screening and enrolment visits),     during (Day 7, Month 1 and Month 2 visits), and after the interventions (Month 6 visit).   "
63105|NCT02459652|"     Multicenter Prospective Phase II Study for Neoadjuvant S-1 and Concurrent Radiotherapy for     Borderline Resectable Pancreatic Cancer      RATIONALE: Borderline resectable pancreatic cancer is frequently related to a positive     surgical margin and has a poor prognosis after resection. Neoadjuvant chemoradiation with     intensive local effect may lead to substantial local control and prolongation of survival in     borderline resectable pancreatic cancer.      PURPOSE: This phase II trial assess efficacy and safety of neoadjuvant S-1 and concurrent     radiotherapy for borderline resectable pancreatic cancer.   "
63106|NCT02459639|"     Using a comprehensive prospective clinical study design, the investigators intend to compare     changes in health-related markers in patients with chronic widespread pain (CWP), undergoing     one of two intervention packages of multimodal health care, namely anthroposophical     integrative care (AIC) or standard care (SC), respectively. AIC combines evidence-based     conventional care with complementary/alternative (CAM) treatments. As markers, the     investigators will use indicators of drug utilization and sick leave, as well as constructs     mirroring possible changes in psychological and existential factors and genomic stability     (such as telomere length and telomerase levels).   "
63110|NCT02459587|"     This study is a randomized controlled trial (n = 500) of a new single-session intervention,     called Crisis Line Facilitation (CLF), compared to an enhanced usual care condition on     utilization of the Veterans Crisis Line and other mental health services as well as suicide     attempt(s). All participants will be recruited during an inpatient psychiatric stay for the     treatment of a recent suicidal crisis and be re-assessed at 3-, 6- and 12-months post     baseline. If successful, the proposed study will provide key data on the potential efficacy     of a brief tool to improve the utilization of an existing resource, the Veterans Crisis Line,     to reduce suicidal behaviors in VHA patients.   "
63111|NCT02459574|"     A streamlined AF ablation procedure done without PV mapping as a daycase is more effective     than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial     fibrillation.   "
63112|NCT02459561|"     The management of obesity is challenging and obesity surgery is by far the most effective     treatment currently available. Recent medical research indicates that it also improves the     management of blood glucose levels in people with type 2 diabetes. Obesity surgery carries     different risks and benefits and it is important to balance these by choosing the right     procedure for each patient. Therefore new effective strategies to prevent and reduce obesity     and its complications such as type 2 diabetes mellitus are needed. This study is designed to     see whether a new device called the EndoBarrier Gastrointestinal Liner helps patients manage     their blood sugar levels and lose weight. It is a randomised, placebo controlled trial which     compares the potential of the EndoBarrier device with conventional drug therapy, diet and     exercise for obesity related type 2 diabetes, and their effectiveness on metabolic state     (HbA1c reduced by 20% and blood pressure below 135/85), weight loss, and quality of life. It     will further evaluate whether any other conditions that may be related to obesity could     become less severe and collect information about complications to determine the safety of the     device. The study will also perform various measurements and tests to understand the     underlying mechanism of the device. After an initial screening visit to determine patients     eligibility, they will be invited for 14 subsequent visits. Patients will be randomised into     either having the EndoBarrier device or standard medical therapy treatment for 12 months     followed by another 12 months follow-up period. They will also be routinely seen by     specialist dietitian who will provide dietetic support throughout the study.   "
63127|NCT02459366|"     The objective of three-year research is to investigate the relationship between thoracolumbar     fascia tissue characteristics, lumbopelvic asymmetry, core muscle contractility,     proprioception and standing balance in different ages of asymptomatic participants and     patients with CMLBP.   "
63128|NCT02459353|"     Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when     added to insulin therapy. The primary objective of this study is to assess the effect of     dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type     2 diabetic patients with inadequate glycemic control on insulin.   "
70534|NCT02362516|"     To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as     safety and tolerability, and to evaluate the effect of different doses of BI 425809 on     biomarkers levels in cerebrospinal fluid.   "
63113|NCT02459548|"     The objective of the study is to compare the results of a follow-up and treatment coordinate     and interactive program performed by the General Practitioners (GP) for Obstructive Sleep     Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by     sleep specialists from the sleep unit.      METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of     severe OSA that should start treatment with CPAP. Participating center is Hospital     Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two     monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care     consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it     was indicated the treatment with CPAP.      Patients will be carried out in both groups the same follow-up visits in two study arms:     basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP     compliance treatment in the two study groups, so that use >= 4h/day is defined as good     adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's     satisfaction by visual-analogical scales and quality of life tests; 2) to establish the     clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP     complications, type, severity and duration; 4) To figure-out the level of take care of the     CPAP machine, substitutions and complements, assistance and technical incidents; 5)     Cost-effectiveness analysis.   "
63114|NCT02459535|"     Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft     drinks may play a role in the development of diabetes.      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence     metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and     even modulate incretin release.      However, it is unclear, if these findings are valid for all kinds of AS, as they are     chemically different. Furthermore, data on human subjects are sparse and controversial.      The investigators will therefore conduct 7 consecutive single oral stimulations with glucose     or AS alone or a combination. Three different AS will be tested.   "
63115|NCT02459522|"     This study aimed to evaluate the reference values for the short-term heart rate variable     (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests     in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.   "
63116|NCT02459509|"     The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better     than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.   "
63117|NCT02459496|"     Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle.     Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted     by pharmacological intervention, although lifestyle modification and dietary treatment would     be favourable.      The researchers therefore investigate dietary strategies such as low-carb and very-low calory     diets regarding their potential to improve metabolism and body weight in (mostly) long-term     T2DM patients.   "
63118|NCT02459483|"     The purpose of this study is to assess the effectiveness of a nurse telephone interview in     the management of cancer patients treated by oral chemotherapy. This is a multicenter     prospective randomized controlled pragmatic interventional trial conducted in collaboration     with two oncology care facilities. Eligible population consists of all patients suffering     from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients     will be enrolled in the study. The experimental group will receive a standard followed by a     medical oncologist, hematologist or radiation therapist as part of routine care, and     telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will     receive a standard followed by a medical oncologist, hematologist or radiation therapist as     part of routine care.      The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most     common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea,     vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity     Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity     grades).   "
63121|NCT02459444|"     The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and     athletes, your goal is to recondition the respiratory muscles, providing optimization of lung     capacity, either for high performance sport as to support metabolic wear caused by illness.     It is generally agreed the positive impact of the application of a TMI Protocol on maximal     inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from     mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or     pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the     muscle; the specificity of training; the reversibility of the gain and muscle atrophy.   "
63122|NCT02459431|"     Randomized controlled trial to determine the efficacy of different needles sizes (22G and     21G) used in endobronchial ultrasound guided transbronchial needle aspiration   "
63123|NCT02459418|"     Comparative PK study after single SC application of Afolia and the reference product (US     Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference     product for the area under the curve (AUC) of Afolia.   "
63124|NCT02459405|"     Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread     means of assessing the viability of a laparoscopic anastomosis. The investigators described     recently the feasibility of microvascularisation assessment with near-infra red technology     (NIR).      The aim of this study is to look at the implementation of this technique in a wider     prospective series of patients undergoing colorectal resection.   "
63125|NCT02459392|"     In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be     examined in (approximately 300) adult patients with low back pain pain caused by failed back     surgery syndrome (FBSS).   "
63126|NCT02459379|"     This is a prospective registry evaluating the safety of performing magnetic resonance (MRI)     scans on patients who have cardiac implanted electronic devices (CIEDs). This includes     pacemakers and implantable cardioverter defibrillators (ICDs). This is not a a new device     approval or new MRI scanner approval, only for a registry of patients who need to have an MRI     scan who already have an FDA approved CIED that is not currently labeled for use in     conjunction with an MRI scan. This registry is very similar to the previously approved     MagnaSafe Registry that is now closed to new enrollment.   "
89660|NCT02112526|"     To characterize the safety profile of ACP-196 in subjects with relapsed or refractory de Novo     Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).   "
63129|NCT02459340|"     The main goal of the proposed project is to assess treatment-induced changes of     electrophysiological and psychophysiological correlates of the capacity to regulate emotion,     executive functions, and clinical measures in individuals with (complex) posttraumatic stress     disorder, dissociative disorders, or borderline personality disorder in naturalistic     inpatient and outpatient settings.   "
63130|NCT02459327|"     This study tests a comprehensive approach to the promotion of school readiness in low-income     families, beginning shortly after the birth of the child, through enhancement of positive     parenting practices (and when present, reduction of psychosocial stressors) within the     pediatric primary care platform. The investigators do so by integrating two evidence-based     interventions: 1) a universal primary prevention strategy (Video Interaction Project [VIP]);     and 2) a targeted secondary/tertiary prevention strategy (Family Check-up [FCU]) for families     with infants/toddlers identified as having additional risks. VIP provides parents with a     developmental specialist who videotapes the parent and child and coaches the parent on     effective parenting practices at each pediatric primary care visit. FCU is a home-based,     family-centered intervention that utilizes an initial ecologically-focused assessment to     promote motivation for parents to change child-rearing behaviors, with follow-up sessions on     parenting and factors that compromise parenting quality.      Two primary care settings serving low-income communities in New York City, NY and Pittsburgh,     PA will be utilized to test this integrated intervention in hospital-based clinics, providing     information about translation across venues where one of the two interventions has been     previously used alone.      The investigators plan to test the VIP/FCU model in a randomized trial of 400 families     utilizing parent surveys, observational data on parent-child interactions, and direct     assessments of children's development, at key points during intervention follow-up. Analyses     will address questions of program impact for the integrated program across all families and     by key subgroups.      The largest single contribution made by this study is to test whether an integrated primary     and secondary/tertiary prevention strategy implemented in pediatric primary care can produce     impacts on early school readiness outcomes, including social-emotional, pre-academic, and     self-regulation. As such, this study has the potential to provide the scientific and practice     communities with information about an innovative approach to promoting school readiness     skills among low-income children.   "
63131|NCT02459314|"     This was a multicenter, prospective, randomized, double-blinded, controlled-trial study in     hypercholesterolemic volunteers (serum LDL-C > 130 mg/dL). Eligible subjects were randomized     to receive either plant sterol and soluble fiber-enriched soymilk or plain soymilk 360 mL/day     (2 packages a day) for 8 weeks. Venous blood samples were collected from the eligible     subjects during pre-treatment (screening period; day -7), every 2 week after treatment (at     the end of week 2, 4, 6 and 8) to test for lipid profiles and fasting blood sugar (FBS).   "
63132|NCT02459301|"     The purpose of this study is to test the safety of a new drug, IPH2201, to see what effects     it has on this type of cancer.   "
63133|NCT02459288|"     A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary     Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet inhibition     and safety observation.   "
63134|NCT02459275|"     The main objective of this project is to asses for safety, feasibility and effectiveness of     an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral     Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical     patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe,     acceptable, and effectively increase protein and energy delivery to critically ill surgical     patients.   "
63135|NCT02459262|"     Part A: The primary objective is to evaluate the safety and tolerability of a potential     vaccine against Group B streptococcus.      Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year     following the first dose.   "
63146|NCT02459119|"     This study will test how well Regorafenib controls disease progression in urothelial cancer     (cancer occurring in the urinary bladder, ureters, or renal pelvis) following previous     therapy with chemotherapy.   "
63136|NCT02459249|"     The objective of this study is to evaluate the effect of a healthy-habits intervention     tailored to the cultural, economical and social context of the target population in     cardiometabolic parameters, for a population with no access to specialized health services.     The intervention was designed considering environmental and economic context like     availability of food and physical activity spaces; cultural factors like social and culinary     traditions; individual food preferences. It encompass a selected set of behavioral and     nutritional strategies aiming to achieve control of metabolic disorders involved and to     reduce the risk for diabetes.      The investigators' study is a nine-month clinical intervention with randomized allocation,     and parallel assignment. For the first six months, the participants in the control group will     receive the treatment from the primary care service by the Health Minister as implemented by     the local health center, and for the intervention group participants will receive a treatment     to improve the quality of the diet and promote the practice of physical activity. Both groups     will be reevaluated at third, sixth and ninth-months follow-up. The physician and the     nutritionist of the study will be give the recommendations for diet and advice on exercise,     mainly by suggesting moderate-intensity activity, such as brisk walks for at least 150     minutes/week.   "
63137|NCT02459236|"     There is a significant unmet medical need for rapidly acting treatment of subjects with     severe major depressive disorder (MDD) who have not adequately responded to antidepressant     therapy. Alternative therapies require weeks to achieve full efficacy, may have significant     side effects, and still fail in a high percentage of subjects. Rapid reduction of severe     depression by pharmacological therapy is important to reduce the need for hospitalization and     risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable,     N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA     receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it     provides rapid onset of antidepressant effects and an effect size similar to that seen with     experimental intravenous NMDA modulators.   "
63138|NCT02459223|"     Present study was designed to evaluate the efficacy of the nutritional intervention, in the     SAM (Severe Acute malnutrition)children by monitoring various Anthropometric,Biochemical     ,Hormonal and Enzymatic parameters before and after the nutritional intervention     treatment.This study was also intended to study possible functional role of gene HRI (heme     regulated inhibitor) as a molecular marker for the early detection of iron deficiency anemia     in malnourished children similarly present study has also tried to find anthropometric marker     and different correlations among study parameters.   "
63162|NCT02458911|"     The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting     balloon luminor 14 & luminor 35 in the treatment of infrainguinal occlusive lesions     (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and     restenosis from prior endovascular procedures in this sector.   "
63139|NCT02459210|"     The purpose of this study is to test the feasibility of a modification of CET (Cognitive     Enhancement Therapy) to address symptomatic and functional difficulties associated with     Clinical High Risk for Psychosis (CHR).      Cognition for Learning and for Understanding Everyday Social Situations (CLUES) is designed     to improve cognitive functioning (e.g., memory, attention, planning, etc.) in order to     improve school, work, and social functioning. CLUES includes the following:        1. Computerized cognitive remediation (exercises) to improve cognition.        2. Social-cognitive skills group designed to teach participants to act wisely in social          situations.        3. Individual coaching sessions designed to enhance translation of skills learned from          computer exercises and the group into real life.      CLUES is based on Hogarty and Greenwald's Cognitive Enhancement Therapy (CET), which was     designed for treating individuals with schizophrenia. Research on CET for individuals with     schizophrenia has found that CET appears to have helped participants improve cognition and     social and work functioning.      This study will investigate the feasibility of CLUES for young people who are showing signs     of clinical risk for psychosis.      Part 1: Preliminary open label trial of CLUES (n=8) to examine preliminary evidence of target     engagement (change in cognition and social cognition), to refine assessment and recruitment     approaches, to further optimize the treatment manual, and to ascertain feasibility and     tolerability.      Part 2: Preliminary randomized controlled trial of CLUES vs supportive therapy (ST) +     computer games to explore preliminary evidence of efficacy of CLUES vs. the control treatment     (n=30).   "
63140|NCT02459197|"     The purpose of this clinical trial conducted in patients suffering from chronic pain is to     study the relationship between individual patients' profile and their analgesic response   "
63141|NCT02459184|"     Social processes that impact the health of individuals have been labeled the social     determinants of health (SDOH). These are the conditions in which people are born, grow,     live, work and age. These circumstances are shaped by the distribution of money, power and     resources at global, national and local levels. Perhaps the most important SDOH is income     security, a person's actual, perceived and expected income. Our objective is to carry out a     pragmatic randomized controlled trial that evaluates the impact of an income-focused health     promoter.   "
63142|NCT02459171|"     This study seeks to determine the incidence and transmission of avian influenza viruses in     humans exposed to poultry. Enrolled subjects will be selected from five different rural areas     (villages) in the Nile delta region in Egypt where poultry are commonly raised. From those     study sites, 2400 healthy subjects will be monitored for 6 years with annual follow up visits     to measure sero-prevalence and exposure variables, and more importantly, biweekly or weekly     visits to measure incidence of infection, measure secondary transmission rates, monitor     symptoms, and assess immunological response.      Primary Objectives:        -  To estimate the incidence of avian influenza (AI) in poultry-exposed human populations.        -  To estimate sero-prevalent of AI in poultry-exposed human populations.        -  To investigate potential risk factors associated with AI human infections in          poultry-exposed individuals.        -  To investigate secondary infection risk for household contacts.      Secondary Objectives:        -  To characterize the antigenic and genetic makeup of AI viruses infecting humans.        -  To monitor the pathogenicity and disease severity of AI viruses causing human infections          and the associated immune response.        -  To investigate the serologic response following confirmed influenza virus infection.   "
63143|NCT02459158|"     This study is a randomized, open-label phase I study. The primary objective of this study is     to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically ventilated     bacterial pneumonia (MVBP). The secondary objective of this study is to assess the safety and     tolerability of ME1100 for the treatment of subjects with MVBP to assess the safety and     tolerability of ME1100.   "
63147|NCT02459106|"     The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal     muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese     individuals. This information will be important for our understanding of how the body's sugar     metabolism is regulated and why people who are obese become insulin resistant and are more     likely to develop type 2 diabetes.   "
63148|NCT02459093|"     A comparison of the type of suture used for cesarean skin incision approximation and the     subsequent rate of wound complications has not been widely studied. Investigators seek to     compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in     Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication     rates (SSI, hematoma, seroma, wound separation).   "
63149|NCT02459080|"     The purpose of this study is to measure the effectiveness and safety of TD 4208, an     investigational drug being developed to treat people with moderate to very severe COPD,     compared to placebo, a treatment without activity.   "
63150|NCT02459067|"     To determine the safety, tolerability, maximum tolerated dose (MTD) and efficacy of     ImmuniCell® in patients with melanoma, renal cell cancer (RCC) or non-small cell lung cancer     (NSCLC). The study is an adaptive design that has 3 stages: Stage 1 - dose escalation, Stage     2 - efficacy, and Stage 3 - confirm efficacy in one of the tumor types.   "
63151|NCT02459054|"     The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support,     and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years)     and can safely and effectively support transplant-eligible adult patients (aged 19 - 75     years) at imminent risk of death from biventricular failure without experiencing permanent     disabling, stroke-related deficits.      The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart     (TAH-t) as a bridge to transplant:        -  The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of          the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age.        -  The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc          TAH-t for transplant-eligible patients 19 through 75 years of age.        -  The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment          criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment          criteria, in order to further characterize the use of the device.   "
63189|NCT02458560|"     The purpose of this study is to assess the safety and device success of the Edwards CENTERA     Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic     stenosis.   "
63152|NCT02459041|"     The study protocol is based on a multi-center semi-quantitative approach of EUS elastography     data in combination with contrast-enhanced EUS, consisting of measuring SR and SH for focal     pancreatic masses and lymph nodes, as well as several parameters of CE-EUS based on     time-intensity-curve (TIC) analysis. A number of parameters must be taken into consideration,     as the ROIs are still manually selected by the user. The aim of the study is to establish an     EUS based diagnostic algorithm in patients with pancreatic masses and lymph nodes, with     negative or inconclusive cytopathology after EUS-FNA, based on previously published results     and cut-offs of elastography and contrast-enhancement. The proposed algorithm of sequential     use of real-time elastography, followed by contrast-enhanced EUS could be a good clinical     tool to help select the patients with possible pancreatic adenocarcinoma or malignant lymph     nodes, in the setting of patients with negative EUS-FNA results.   "
63153|NCT02459028|"     Background:      Chronic pain is one of the most burdensome potential consequences of a physical disability,     such as spinal cord injury (SCI). Estimates of the incidence of chronic pain in SCI range     between 65 - 80%. A recent pilot-study of a computer-based tailored positive psychology     intervention showed a significant reduction in pain intensity, pain interference, pain     catastrophizing and depression and an enhancement of subjective well-being and control over     pain in persons with chronic pain secondary to a physical disability.      Study Objective:      Objective 1: To determine the efficacy of a tailored positive psychology intervention (T3P)     in a community-based, single-blind, randomized, controlled, parallel group trial on     subjective well-being and pain in individuals with chronic pain secondary to SCI.      Hypothesis 1: T3P will result in (1) greater immediate and long-lasting increase in     subjective well-being, and perceived control over pain and (2) greater immediate and     long-lasting decrease in depression, pain intensity, pain interference and catastrophizing,     relative to an active control treatment.      Specific aim 1: To increase the understanding of the mechanisms underlying T3P by determining     potential mediation effects.      Hypothesis 2: (1) Pain catastrophizing and pain control mediate the effect of T3P on pain     intensity, and (2) positive and negative affect mediate the effect of T3P on life     satisfaction and depression.      Objective 2: To identify for whom T3P is most effective by exploring potential moderator     effects.      Study Design:      The proposed study is a single-blind, randomized, controlled trial with a parallel group     design to determine the effects and mechanisms of T3P in a Swiss community sample of persons     with chronic pain secondary to SCI.   "
63154|NCT02459015|"     The purpose of this clinical investigation is to confirm the medium- and long-term safety and     performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an     autologous nerve graft to bridge nerve defects in the finger.   "
63155|NCT02459002|"     The goal of this study is to learn about the quality of life (QOL) in participants with     advanced lung cancer.   "
63156|NCT02458989|"     This study looks at the difference in surgical scar outcomes between two different surgical     incision methods during thyroid surgery: scalpel vs electrocautery. Patients who are already     scheduled for thyroid surgery with Dr. Sam Wiseman, Endocrine Surgeon at St. Paul's Hospital,     and that meet the eligibility criteria for this study will be invited to participate. After     signing the informed consent form, participants will be randomized into either one of the two     incision methods, but will not know which one they receive. There will be two follow-up time     points: one at 6 and another at 12 months post-operative. At these time points the research     team will send a letter to the participant asking them to rate the appearance of their     surgical scar. They will also be asked to take a picture of their scar and send it back to     the research team, so that the research team can make an assessment of their surgical scar.     The study concludes when the 12 month follow-up is complete.   "
63318|NCT02456857|"     The goal of this clinical research study is to learn if receiving 4 cycles of experimental     chemotherapy before surgery can help to shrink the size of tumors in the breast and/or lymph     nodes before they are removed through surgery. The safety of this combination will also be     studied.   "
63157|NCT02458976|"     This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior     to surgical excision can improve the appearance and symptoms of scars. The primary outcome     measurement for the study is the quality of the scar in areas pre-treated with PDL vs.     control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic     surgical excision will have half of the surgical area pre-treated with PDL and the other half     pre-treated with cryogen spray.   "
63158|NCT02458963|"     The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus     gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic     ovarian syndrome (PCOS).   "
63159|NCT02458950|"     This study is aimed to determine clinical characteristics of patients with anorexia nervosa     and outcome of treatment at Sirirraj Hospital.   "
63160|NCT02458937|"     Although uncommon in the general pediatric population, osteonecrosis (ON) is prevalent in     children and adolescents with cancer, particularly among those that have had chronic exposure     to glucocorticoids and among those having undergone allogeneic hematopoietic stem cell     transplantation. Patients with hematologic disease are also at risk for developing ON.      Hip Core Decompression (HCD) is a widely used surgical procedure with several studies     reporting positive results; however, most are subject to criticism because of the limited     sample size or the absence of appropriate functional outcome measures.      The objective of this pilot study is to observe and collect information on several functional     outcome measures and assess if Hip Core Decompression (HCD) potentially improves functional     outcomes in children, adolescents and young adults with osteonecrosis.      PRIMARY OBJECTIVE:        -  To describe functional outcomes of children, adolescents, and young adults with          osteonecrosis of the femoral head following hip core decompression surgery. Parameters          assessed will include pain, functional mobility, endurance, quality of life, and gait          patterns pre-operatively and post-operatively over time.   "
63161|NCT02458924|"     Patients with schizophrenia have abnormal skin flush response to niacin, but the niacin skin     test accuracy is not well studied in these patients. The study evaluated the niacin skin test     accuracy in adult hospitalized schizophrenia patients and their first degree relatives,     bipolar disorder patients, and healthy controls.   "
70535|NCT02362503|"     The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068)     is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug     resistance.   "
63163|NCT02458898|"     This is a prospective randomized controlled trial investigating the impact of educational     bidirectional text message reminders on gluten free diet adherence among adolescents and     young adults with celiac disease age 12-24. Participants will complete a series of online     questionnaires assessing quality of life, patient activation, celiac symptoms, and self     reported dietary adherence at the beginning and end of the study. Participants will also have     their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated     Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done     locally, and are at no cost to the participant. Patients are randomized to the intervention     or control group based on enrollment TTG IgA. Intervention group receives 45 unique text     messages over the 3 month study. A gift card is provided for participation in the study.   "
63164|NCT02458885|"     Aim of investigators is to conduct a registry of acute myocardial infarction including a     broad network of critical care / coronary care unit throughout Argentina to increase the     knowledge about treatments, timing of reperfusion therapy and outcomes, both in-hospital and     during short-term follow up.   "
63165|NCT02458872|"     This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a     safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient     units.   "
63166|NCT02458859|"     Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus     standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to     investigate Time to healing, health economic and patient reported outcomes.   "
63167|NCT02458846|"     Amblyopia (lazy eye), is the leading treatable cause of vision loss in childhood. Uncorrected     refractive errors (ie farsightedness) can lead to difficulties in school. Unfortunately, many     children do not receive vision screening until they have already developed irreversible     vision problems. This has led to the development of a variety of screening protocols and     devices that attempt to identify patients at risk for vision problems early in life. This     study aims to compare the leading vision screening devices/protocols to a new device, The     Pediatric Vision Scanner, and compare their ability to detect vision problems against a gold     standard eye exam.   "
63169|NCT02458820|"     Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with     worse neurologic outcomes and increased mortality. More prolonged seizures (status     epilepticus) are associated with worse outcomes. Earlier diagnosis and treatment of seizures     may lead to earlier termination of seizures and decreased seizure burden.      This study will evaluate whether bedside intensive care unit (ICU) provider interpretation of     a type of EEG called DSA EEG can be used by non-neurologists to diagnosis seizures more     rapidly than continuous EEG's routinely read by neurologists.   "
63182|NCT02458651|"     The purpose of this observational study is to describe patient and disease characteristics as     well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small     cell lung cancer (NSCLC). In addition, this study characterizes the clinical outcomes for     various populations of patients defined by clinical and tumor characteristics, treatment     patterns, and hospital category defined by city tier and geographic region.   "
63183|NCT02458638|"     The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18     weeks in participants with advanced solid tumors treated with atezolizumab, defined as the     percentage of participants with complete response (CR), partial response (PR), or stable     disease (SD) as assessed by the investigator according to Response Evaluation Criteria in     Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate     cancer and malignant pleural mesothelioma.   "
63170|NCT02458807|"     The World Health Organisation predicts that lung disease will be the World's third largest     killer in the future. This research project is looking to see whether the concept of a home     hospital using the latest gadgets and iPad technology, can help patients stay well and out     of hospital.      Portsmouth Hospitals Trust is collaborating with a Company based in the United Kingdom (UK)     who has developed a test to predict when people with lung diseases, such as; asthma, COPD and     bronchiectasis, who regularly have chest infections, are about to become poorly with another     infection - a form of early warning system. The investigators hope that the test will     eventually be able to be used by the patient at home daily, to help self-manage their     condition. The test measures whether bacteria are present, in sputum, and in what quantity.     This information can be used by the patient's healthcare team to consider providing treatment     earlier, thus controlling the infection sooner and reducing the patient's symptoms so that     patients can stay at home rather than being regularly admitted to hospital.      Part of this early warning system that has been developed by the UK Company includes the     daily measurement of a number of indicators of health. These are usually only measured in     hospital or by a General Practitioner, but new devices have been made that are simple enough     for everyone to use at home.      The investigators will include 30 participants, with non-Cystic Fibrosis (CF) chronic     respiratory conditions who will be asked to take daily measurements of their blood pressure,     temperature, weight and how well their heart and lungs are working with easy-to-use devices.     They will also measure their physically activity with an activity tracker and report their     wellness and whether they have taken medication daily. Participants will also be asked to     collect a sample of sputum and urine each morning. Taking the samples and measurements should     only take between 5-15 minutes each day to carry out.      The sputum and urine will be tested at the hospital and will be recorded and analysed, so     that the researchers can learn what happens well before a person with these conditions falls     sick and needs hospitalisation.   "
63171|NCT02458794|"     The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of     both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate     ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM     (single use - prevention of disease transmission). In the following randomized, crossover     study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak     pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura     GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.   "
63172|NCT02458781|"     This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of     ciprofloxacin versus metronidazole versus placebo in eradication of small intestinal     bacterial overgrowth (SIBO).   "
63173|NCT02458768|"     The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by     evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro     fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.   "
63199|NCT02458430|"     Balance and gait problems cause severe impairments for people with Parkinson's disease In     some Parkinson's disease patients the investigators see a loss of acetylcholine in the brain.     In previous studies the investigators have shown that this loss of acetylcholine is related     to impaired balance and gait function in Parkinson's disease. In this study the investigators     will take a closer look at this finding.   "
63174|NCT02458755|"     Purpose: Intracranial atherosclerosis is a common condition in Korean population consisting     over 25% of ischemic stroke etiology. American Stroke Association and Korean Stroke Society     recommend antiplatelet and statin for the treatment of intracranial atherosclerosis. Besides     lowering blood cholesterol levels statin also stabilize atherosclerotic plaque and eventually     lower the risk of ischemic stroke. However, little evidence resides on the effect of statin     treatment on intracranial atherosclerosis. Recent advance in high-tesla magnetic resonance     imaging enables direct imaging of intracranial atherosclerotic plaque and further assessment     of treatment efficacy of statin in stabilization of intracranial atherosclerotic plaque     became possible.   "
63175|NCT02458742|"     Pain after transurethral resection of prostate is considered mild to moderate severity from     detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have     been studied including spinal opioids, spinal anesthesia with local anesthetic and     dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with     distilled water irrigation while undergoing a procedure. Most of patients having this     procedure are in elderly period, thus many anesthetists avoided spinal morphine which may     cause respiratory depressant effect postoperatively. Although previous studies showed     effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid     side effects.      The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal     morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to     spinal anesthesia with sole local anesthetic.   "
63176|NCT02458729|"     The aim of this study was to conduct a prospective, randomized, double-blind study and assess     the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty     patients when tranexamic acid is used for bleeding prophylaxis.   "
63177|NCT02458716|"     This phase I trial studies the side effects of cytoreductive prostatectomy in treating     patients with newly diagnosed prostate cancer that has spread from the primary site to other     places in the body. Cytoreductive prostatectomy is a type of surgery that removes the     prostate and as much of the tumor as possible. When combined with hormone therapy, robotic     assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy     (RRP) may prolong survival in patients with prostate cancer that has spread.   "
63178|NCT02458703|"     Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the     lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This     study will examine the exercise capacity of PAVM patients using formal cardiopulmonary     exercise tests performed on a stationary bicycle, and whether this is affected by the     presence of concurrent airflow obstruction, such as due to asthma.   "
63179|NCT02458690|"     The objective of this randomized controlled trial is to evaluate whether the investigators     modernized IMPACT intervention for depression (eIMPACT), delivered before the onset of     cardiovascular disease (CVD), reduces the risk of future CVD. Participants will be primary     care patients who are depressed but do not have a history of CVD. Half of the participants     will receive standard depression treatment in primary care (usual care), and the other half     will receive one year of eIMPACT, a collaborative stepped care program including     antidepressants and computerized and telephonic cognitive-behavioral therapy. To evaluate     change in CVD risk, the investigators will measure artery function using ultrasound before     and after the 1-year treatment period. It is hypothesized that patients who receive the     eIMPACT intervention will have greater improvements in artery function than patients who     receive usual care.   "
63180|NCT02458677|"     This single ascending dose study is to determine safety, tolerability, pharmacokinetics and     immunogenicity of PRX003 in approximately 40 healthy subjects.   "
63181|NCT02458664|"     We collect prospectively and retrospectively, patients' demographic, pathological, surgical,     therapeutic and prognosis informations in a database. After patient's consent to collect     tumoural samples of their colorectal cancer after resection.      We will then be able to evaluate the impact of HSP110, a chaperon protein, on their     prognosis. Other proteins (to be determined) will also be study, after.   "
63185|NCT02458612|"     The purpose of this study is to investigate the effects of mirror therapy combined with upper     extremity strengthening training on upper extremity function in children with unilateral     spastic Cerebral Palsy (CP): a single blind randomized controlled trial. In the literature,     there was no randomized controlled trial. According to literature, there are few studies that     investigate the effects of mirror therapy in children with CP. But there is no randomized     controlled trial, explore the effects of mirror therapy combined with upper extremity     strength training on upper extremity functions in unilateral spastic CP. Hypothesis of this     study is that mirror therapy combined with strength training improves upper extremity     function and muscle strength in unilateral spastic CP.   "
63186|NCT02458599|"     This study is designed to investigate whether protein supplementation can improve recovery of     muscle function following a strenuous combination of both endurance and resistance exercise.     It will specifically investigate the effect of protein supplementation on the recovery of     strength, power and endurance exercise performance, along with measures of damage and     inflammation of the muscle.   "
63187|NCT02458586|"     Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids     (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid     content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver     disease (NAFLD).      The investigators therefore conduct an interventional trial in subjects with normal glucose     metabolism, but increased HCL, fulfilling criteria for NAFLD.      The study will compare two dietary interventions in parallel design, one containing mainly     PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is     accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR     spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin     sensitivity).   "
63188|NCT02458573|"     The investigators hypothesized that sympatholytic effect of epidural analgesia would     attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by     pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural     analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing     laparoscopic gastrectomy.   "
63190|NCT02458547|"     Despite many previous studies, whether anesthetic technique will significantly affect overall     patient outcome, morbidity and mortality in elderly hip fracture patients is controversial.     Due to old age, poor patient condition and emergent clinical settings, patients undergoing     surgical procedures for hip fracture management are often subject to poor postoperative     outcome and high mortality rates. While many studies have reported that regional anesthesia     leads to improved postoperative outcome after hip fracture surgery, others have concluded     otherwise. Moreover, because the majority of these previous studies are retrospective cohorts     or systemic reviews, there is a need for randomized clinical trials to provide high quality     evidence. This study aims to compare patient outcome between three different anesthetic     techniques in elderly patients undergoing surgery for hip fracture management by evaluating     proinflammatory cytokines, chemistry lab testing and clinical outcome between general     anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with     bupivacaine.   "
63191|NCT02458534|"     The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is     superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for     novice users in manikin.   "
63192|NCT02458521|"     The overall objective of this project is to determine the efficacy and tolerability of TMS     for mild Traumatic Brain Injury (mTBI) with PTSD symptoms and correlate treatment response     with anatomical and biological factors unique to each service member (SM). Exploratory work     will be done to look at the neuronal and biological changes that may occur over the course of     TMS treatment.   "
63193|NCT02458508|"     Glioblastoma (GBM) accounts for approximately 50% of all glioma and among these tumors, are     the most malignant. The cells of origin of glioma are still undefined, but the most putative     target cells include astrocytes, neural stem cells, and oligodendrocyte precursor cells. The     current standard of care for patients with newly diagnosed GBM includes temozolomide and     radiotherapy . Melanocortins are peptides with well-recognized anti-inflammatory and     neuroprotective activity. Of the five known melanocortin receptors (MCRs), only subtype 4 is     present in astrocytes and it is expressed predominantly in the brain. No data are currently     available on MC4R gene polymorphisms and gliomas or their relationship with radiotherapy or     chemotherapy.      Aim. Given the association of MC4R with antiinflammatory activity, neuroprotection, induction     of neural stem/progenitor cell proliferation in brain hypoxia, and prevention of astrocyte     apoptosis, the aim of this study is to retrospectively evaluate the possible     prognostic/predictive role of the MC4R SNPs on GBM therapy.   "
63194|NCT02458495|"     A significant percentage of persons with diabetes fail to properly take their prescribed oral     hypoglycemic agents (OHA) and insulin. Non-adherence to medications among diabetes patients     is associated with poor health outcomes including suboptimal glycemic control,     diabetes-related complications, elevated health costs and increased risk of hospitalization     and mortality. Given the substantial impact of non-compliance on the health of patients,     prior studies have sought to draw links between medication adherence and patient factors.      Research shows that web-based interventions that support patients' medication-related     knowledge, motivation and skills effectively improve compliance.      The purpose of this study is to evaluate the impact of a patient web portal (PWP)-delivered     medication adherence promotion intervention on medication adherence and glycemic control     among patients with type 2 diabetes (T2DM). The intervention aims to (1) increase     self-reported adherence to glucose lowering agents (GLAs) and (2) improve diabetes health     outcomes (decreased HbA1c) by increasing patients' medication adherence-related knowledge,     motivation and skills.      This research will greatly enhance the investigators' understanding of medicine compliance     and the factors that effectively improve adherence among high-risk patients with diabetes.     Knowledge gained from this work may inform future internet-based patient portals that support     disease management and medication adherence more broadly.   "
63319|NCT02456844|"     To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam,     digoxin, pravastatin, and MTX when coadministered with BMS-986142.   "
63195|NCT02458482|"     The objective of this randomized control trial is to investigate the efficacy of an adjunct     positive airway pressure (PAP) nebulizer device known as AccuPAP in the treatment of     moderate-severity acute asthma exacerbations in children ages 6 - 17 years in comparison with     an institutional standard continuous dual-therapy nebulizer treatment.      The investigators main goal, more specifically, is to determine if the additional positive     airway pressure provided by the AccuPAP device when used in treating children with     moderate-severity asthma exacerbations provides a more optimal delivery of bronchodilator     therapy when compared to institutional standard protocol nebulizer delivery mask which does     not employ the use of positive airway pressure in medication delivery. The investigators have     determined that the change in a study-validated Acute Asthma Intensity Research Score (AAIRS)     which will be considered statistically significant for a patient is 2 points or greater after     the first treatment has been completed.   "
63196|NCT02458469|"     The purpose of this study is to look at the effect of exciting using drugs to target a     specific pathway in the body, that relies on a natural chemical the body produces called     'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the     study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone     (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of     time followed by two weeks without drugs (washout period). The drugs will not be taken all at     the same time, but each will be taken separately for two weeks followed by a night study to     look at the effect the medication/placebo pill has on the way the body responds during sleep.   "
63197|NCT02458456|"     The aim of this project is to conduct a randomised controlled trial to assess the effect of     performing isometric exercise using a handgrip dynamometer on blood pressure.   "
63198|NCT02458443|"     Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic     exercise for lowering blood pressure. The investigators intend to conduct the largest,     longest, prospective, double-blind randomized controlled trial using isometric resistance     training to reduce blood pressure to reduce hypertension.   "
63200|NCT02458417|"     The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2     laser abrasion with superficial full surface ablation, fractional laser treatment and     conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the     patient reported outcome and to assess the cellular composition of the graft.   "
63203|NCT02457559|"     This study will determine the long-term safety, tolerability, and efficacy of tirabrutinib in     adults in a prior tirabrutinib study and whose disease had not progressed on the parent     study. The dosing regimen will be based on the prior dosing regimen from the parent study.   "
63204|NCT02457546|"     The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant     (Human) for use as an adjunct to sutured dural repair in cranial surgery.   "
63205|NCT02457533|"     To investigate the effects of patient counseling by telephone on Quality of Life and the use     of Health care system.   "
63207|NCT02457507|"     Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic     people. Vitamin B12 deficiency in older people is associated with cognitive impairment and     Alzheimer's disease. Vitamin B12 deficiency may therefore contribute to cognitive decline in     older diabetic people.      Objective: To determine whether the correction of mild vitamin B12 deficiency in cognitively     normal older diabetic people reduces the incidence of cognitive decline.      Design: randomized, double blind, placebo controlled trial Subject: Cognitively normal     diabetic outpatients aged 70 years or older with plasma vitamin B12 150-300 pmol/L in medical     and family medicine/ general outpatient clinics.      Procedure: After excluding those with clinical manifestations of vitamin B12 deficiency and     without family member who can reliably inform on cognitive functioning (personal contact at     least once a week), eligible patients will be invited to participate in this clinical trial.     After obtaining written consent, research assistant (RA) will record demographic and clinical     information from the subjects and perform neuropsychological tests - 1. Clinical dementia     rating scale (CDR), 2. neurocognitive test battery (see below) 3. Chinese Mini mental state     examination (MMSE), 4. Geriatric depression scale (GDS). Fasting blood will be taken for     serum methylmalonic acid (MMA). Those with cognitive impairment and significant comorbidities     will be excluded.      264 eligible subjects will be randomly assigned to take either two Vitamin B12 500 microgram     or two identical looking placebo tablets once daily for 27 months.      All subjects or family caregivers are reviewed in the research clinic every 12 weeks in which     the research assistant performs a pill count and dispenses the trial tablets. At 9 monthly     intervals, the subjects will have neurocognitive test battery repeated at research clinic.     CDR will be repeated at month 18 and 27. At month 9 and 27, fasting serum MMA and vitamin B12     will be repeated.   "
63208|NCT02457494|"     The purpose of this study is to define the cause of renal stones and the risk pattern for     recurrence of renal stones episodes (any kind of stones) in HIV1 patients.   "
63209|NCT02457481|"     The purpose of this research study is to evaluate a newly developed embryo culture media     system for human clinical use in ART.   "
63210|NCT02457468|"     The purpose of the coflexCOMMUNITY observational study is to collect information on patients     with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their     outcomes and the cost-effectiveness of this procedure.   "
63211|NCT02457455|"     The aim of this study is to evaluate the incidence and status of urgent medical conditions.     After defining the urgent situations, the investigators will evaluate the adequacy of the     standard medical kits and trainings.   "
63320|NCT02456831|"     This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term     infants with reported intolerance to a milk-based formula.   "
63212|NCT02457442|"     Recently a new model for the interaction of sevoflurane propofol and remifentanil was     developed. The potency of any combination of the three drugs is defined as probability that a     subject tolerates laryngoscopy without movement response. The model allows to compare the     potency of intravenous and inhalation anesthetics. If the model is valid also for other     stimuli than laryngoscopy and for other responses (e.g. blood pressure or heart rate increase     upon stimulation). If the model is valid equipotent concentrations of sevoflurane and     propofol the same remifentanil concentration would be sufficient to suppress hemodynamic     response to a given stimulus. This will be investigated it the study.   "
63213|NCT02457429|"     Gastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a     variety of symptoms in both adult and paediatric populations. In children the effects of     refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory     factor in the underlying pathological processes of a number of conditions including apnoea,     asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The     absence of typical symptoms in addition to the inability to obtain a formal symptom history     from a young paediatric population contributes to the difficulty in establishing a diagnosis.     At present there are no studies or data directly measuring extraoesophageal reflux and its     correlation to oesophageal pH monitoring in children.      The use of twenty-four hour oesophageal pH monitoring is regarded as the established     technique for diagnosis of GORD, however this technique has been less reliable for detecting     extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a     sensitive and minimally invasive transnasal device, to assess the feasibility and validate     its use in a paediatric population.   "
63214|NCT02457416|"     The purpose of the study is to identify prognostic markers and possible success rate of     tolerance induction to peanut allergens in children allergic to peanut.   "
63215|NCT02457403|"     A prospective, randomized clinical trial comparing blood product use and bleeding events     during and after endoscopic or neurosurgical procedures in patients with cirrhosis and     coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).   "
63216|NCT02457390|"     Laparoscopic ultrasound examination performed during surgery for primary cancer of the colon     and rectum (CRC) has been shown to be able to detect liver metastasis that are not recognized     by conventional computer tomography (CT scan) prior to surgery.      Today most of the colorectal cancer resections are performed by laparoscopy, but robotic     technology is gradually developed in an attempt to overcome some of the limitations     characterized by laparoscopy. The use of contrast enhanced laparoscopic ultrasound     examination (CE-LUS) of the liver during robot-assisted CRC surgery has not been studied, and     this despite the fact that it seems technically possible to perform.      With this project we will investigate whether CE-LUS associated with robotic surgery for CRC     is technically feasible and whether it will be able to detect synchronous liver metastases     that have not been detected on the preoperative imaging modalities.   "
63239|NCT02458105|"     The overarching aim of the research project is to investigate whether Acceptance & Commitment     Therapy (ACT) is an efficacious psychotherapeutic method of treatment for inpatients     suffering from acute psychosis.      The method will be applied in two ways. Firstly, as an individual treatment for patients.     Secondly, as an integrated part of the daily work on an inpatient ward, administered by     nurses and assistant nurses trained in the method.   "
63240|NCT02458092|"     The purpose of this study is to determine whether an investigational malaria vaccine is safe     and induces an immune response against malaria when tested in adults living in the United     States.   "
63217|NCT02457377|"     A 5-mm non-absorbable Mersilene polyester suture, with adjacent partially straightened blunt     needles, is introduced into the abdominal cavity through the 5-mm trocar. However, flattening     the curvature of the needles, while introducing the tape into the abdomen, will eventually     pose a challenge during placement of the stitch (the needles' curvatures guarantee that the     tissue penetration is done away from the uterine vessels).      To overcome this problem, the following method was devised. A one cm suprapubic incision is     made on the abdomen with a scalpel short of the peritoneum. A needle holder loaded with the     needle is pushed through the incision until the tip is seen inside the peritoneal cavity. A     grasper from one of the flank ports receives the tip and the needle is delivered carefully     (FIGURE 1). The rest of the tape is pulled until the blunt end of the other needle appears,     to be delivered in the same way but in the reverse order.      • Operative Steps The vesico-uterine peritoneum is opened using scissors & the urinary     bladder is dissected downwards from the lower uterine segment to expose the uterine vessels     anteriorly on both sides . Both needles are passed through the lower uterine tissue medial to     uterine vessels on the right & left sides (from anterior to posterior) . Then, both needles     are passed through the remaining cervical tissue medial to uterosacral ligaments towards the     posterior vaginal fornix (on the right & left sides) guided by laparoscopic illumination .     When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the     posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly     behind the intravaginal segment of the cervix with five knots & the ends of the stitch are     trimmed. The vesico-uterine peritoneum is then reapproximated over the laparoscopic cerclage     with a running (00) Monocryl suture that is tied intracorporeally.   "
63218|NCT02457364|"     Ventral hernias are among the most common surgical diseases among patients.The natural     history of patients with ventral hernias who are managed non-operatively is unknown. The aim     of this prospective trial is to document the natural history of patients who are undergoing     initially non-operative management. The investigators hypothesize that 1) the risk of     emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is     high, and 3) patients managed non-operatively will develop increasing hernia size and symptom     progression. This is a prospective observational study of all patients undergoing     non-operative management at LBJ General Hospital. Patients will be consented and then     followed for 5 years. Phone interviews will be done with these patients yearly to assess     surgical and medical history, information about their hernia, including pain level due to the     hernia, as well as function and quality of life.   "
63219|NCT02458365|"     Male-to-female intimate partner violence accounts for 26% of violence-related injuries in     women presenting in hospital emergency departments and 33% of all female homicides.     Adolescence provides an excellent window of opportunity for the prevention of intimate     partner violence. Patterns of relating in intimate relationships are still relatively     undifferentiated and open to influence. However, the evidence supporting traditional,     school-based programs for the prevention of teen dating violence is mixed. A major problem     with existing programs is that they are one size fits all, making it difficult to meet the     diverse needs of students—boys and girls, individuals who are dating and those who are not,     individuals who have experienced dating violence as a victim, perpetrator, or both, and those     who have not. Perhaps most importantly, these interventions neglect individual differences in     readiness to use healthy, non-violent ways of relating to stay violence-free. In Phase I the     objective was to use expert system technology to integrate best practices for teen dating     violence prevention with the Transtheoretical Model of Behavior Change (TTM), the stage     model, to develop an interactive, multimedia computer-administered change program that     delivers individualized intervention sessions and exercises tailored to stage of change and     other individual characteristics. In Phase II, the objective was to complete development of     the intervention package and assess its efficacy in a randomized clinical trial involving     3,901 teens from 20 Rhode Island high schools randomly assigned to intervention or     comparison. Among youth exposed to risk for dating violence, efficacy was assessed by     comparing the intervention and comparison groups on dating violence perpetration and     victimization at follow-up. Among youth not exposed to risk for dating violence, efficacy was     assessed by comparing intervention and comparison on peer violence perpetration and     victimization.   "
63220|NCT02458352|"     The aim of the study is to compare the CACS obtained from standard dose CT to the CACS     obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC     of myocardial perfusion SPECT will be assessed.   "
69472|NCT02376452|"     This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with     FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line     setting.   "
63221|NCT02458339|"     The goal of this clinical research study is to establish the maximum tolerated dose (MTD) of     direct administration of methotrexate into the fourth ventricle of the brain in patients with     recurrent malignant brain tumors including medulloblastoma, primitive neuroectodermal tumors     (PNET), atypical teratoid/rhabdoid tumors (AT/RT), and ependymoma.      Methotrexate is designed to block cancer cells from dividing, which may slow or stop their     growth and spread throughout the body. This may cause the cancer cells to die.   "
63222|NCT02458326|"     Fibromyalgia and migraine are diseases with high prevalence in women between the age group of     30-60 years, which seem to share the same pathophysiological mechanism; both originate from     neuroendocrine disorders of the hypothalamic-pituitary axis in the central nervous system,     and are therefore closely related. In addition to the strong relationship with migraine,     fibromyalgia can also be associated with sleep disorders, chronic fatigue and psychological     disorders. The combination of these factors decreases the quality of life and contributes to     increased sedentary this population. It is known that physical exercise promotes positive     changes in pain pathophysiological pathway to increase the release of endorphins     neuroendógenas, improving the symptoms of fibromyalgia.      The objective of this study is to analyze whether the application of an aerobic exercise     program may result in the reduction of the frequency, duration and intensity of migraine     attacks in women with fibromyalgia. For this, a clinical trial will be conducted randomized     double-blind clinical trial comparing two groups of women diagnosed with fibromyalgia and     migraine. Initially, all answer questionnaires assessing quality of life, impact of headache,     level of depression and anxiety, sleep quality, physical activity level, and; will be held     ergospirometry for research in exercise tolerance. The experimental group will implement the     protocol consists of heating, aerobic exercise according to the heart rate established for     training by spirometry and slowdown; and the control group will hold the heat on low speed     and heart rate will next baseline. Both groups will be followed for 12 weeks, with a     frequency of three weekly meetings lasting 30 minutes and re-evaluated every 4 weeks. At the     end of the protocol, the groups will have their results were compared and statistically     analyzed.   "
63224|NCT02458300|"     The objective of this study is to evaluate the clinical response of children diagnosed with     acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment     with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2     years.   "
63225|NCT02458287|"     This study is a multicenter, randomized study in subjects with high cholesterol receiving     statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of     bococizumab and an autoinjector (pre-filled pen).   "
63241|NCT02458079|"     Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a     dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current     studies and liver transplantation is with great risk of recidivism in this difficult to treat     cohort of patients. Dysbiosis forms the central role in severe alcoholic hepatitis patients     and modulation of gut microbiota by way of healthy donor fecal transplantation could prove to     be a novel way to treating these patients who are ineligible for standard therapy. This study     utilizes correction of dysbiosis in severe alcoholic hepatitis and surveys outcomes with the     same with respect to survival and liver disease severity scores.   "
63226|NCT02458274|"     The main long-term complication of lung transplantation is chronic lung allograft dysfunction     (CLAD). Bronchiolitis obliterans syndrome (BOS) is the most frequent presentation of CLAD.     BOS leads to a progressive loss of lung allograft function, with recurrence of dyspnea and     airflow limitation. In some advanced cases, patients need a lung re transplantation. The     mechanisms of BOS are not completely elucidated, and there are no early markers or specific     treatment available for this condition.      Microparticles (MPs) are submicron plasma membrane fragments released into the vascular     compartment or the pericellular space in response to cell activation, injury or apoptosis.     Broncho alveolar and circulating MPs may reflect cellular insults of the lung allografts.     Therefore, MPs could be viewed either as biomarkers or as effectors of the chronic     inflammatory or procoagulant processes leading to bronchiolitis obliterans syndrome.      The investigators plan to include 60 patients before lung transplantation at our centre in     Strasbourg (France). Follow-up will be requested at the base of usual care (spirometry, blood     sampling, bronchoscopy with broncho-alveolar lavage [BAL]). The investigators will measure at     one month, one, two and three year post transplantation, the total concentration of MPs in     plasma and BAL and characterize their phenotype.      The investigators objective is to demonstrate correlation between total MPs concentration in     broncho-alveolar lavage fluid (BALF) and the occurrence of bronchiolitis obliterans syndrome     at three years post lung transplantation.   "
63227|NCT02458261|"     This prospective, multi-center study aims to determine the pharmacokinetics and     pharmacodynamics of extended-infusion cefepime in continuous renal replacement therapy     (CRRT).   "
63228|NCT02458248|"     Chronic kidney disease, which affects an estimated 300,000 people in Ireland and over 50     million people in the developed world, is responsible for a considerable burden of premature     mortality and morbidity. All patients with chronic kidney disease are recommended low salt     diets, i.e. less than a teaspoon of salt per day (which is <5-6g of salt, which contains     <2-2.3g of sodium). The average intake in the general population is double the recommended     intake, between 1-2 teaspoons per day, which is considered 'moderate' intake. In patients     with hypertension, reducing from moderate (average) to low intake is associated with a small     reduction in blood pressure. However, achieving this low target salt intake is difficult, and     can have a negative knock-on effect on other healthy dietary factors and kidney hormones. In     addition, there is no convincing research to show that patients with chronic kidney disease     and normal blood pressure benefit from low salt intake. In fact, the small amount of research     that does exist shows that the change in kidney function is the same in people who consume     low salt diets (<1 teaspoon) and moderate (1-2 teaspoons=average intake) salt diets.     Moreover, there are some small studies that report that low-salt diets may increase the risk     of death due to heart disease. Given that all patients with chronic kidney impairment are     recommended a low-salt diet, it is important that we confirm that this recommendation truly     benefits patients. In this randomized controlled trial, we hope to determine whether     recommending a low salt intake, compared to average/moderate intake, is associated with a     slower rate of decline in kidney function in patients with chronic kidney impairment. The     results of this study will provide information to guide future research that will have     critical implications for management of patients with chronic kidney disease.   "
63229|NCT02458235|"     The goal of this study is to determine whether post-transplant consolidation with azacitidine     combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the     prevention of relapse in pediatric and young adult patients with hematologic malignancies who     have undergone hematopoietic stem cell transplantation (HSCT).   "
63255|NCT02457884|"     Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has     swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity     finally. However, some patients still have difficulties in reading even after proper     treatment.      In this project, the investigators aimed to explore the effectiveness of different training     paradigms in improving reading performance in patients with DMO.   "
63230|NCT02458222|"     Aphasia is a language impairment experienced by about one third of stroke patients. This     often devastating condition is treated by speech and language therapists (SLTs). There is     evidence that language games delivered at the right intensity are an efficacious means of     improving communication for people with post stroke aphasia. However, it is unclear which     mechanism of language facilitation used in a game works best. This study will provide     evidence for the active ingredient of a game, together with measures of efficacy,     feasibility and enjoyment compared to standard aphasia therapy.   "
63231|NCT02458209|"     This is an open label, single dose, randomized, parallel group study in healthy adult     subjects to assess the comparability of bococizumab administered in a prefilled syringe vs.     prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs.     Boehringer Ingelheim Pharma.   "
63232|NCT02458196|"     This is an open-label randomized controlled trial to compare the efficacy of Prednisone alone     and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.   "
63233|NCT02458183|"     The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV     combination vaccine compared with those of separate DTaP and IPV vaccines administered to     healthy infants at 2, 4, and 6 months of age.   "
63234|NCT02458170|"     The purpose of the project is to examine what kind of molecular mechanism which causes     inflammatory joint diseases. This examination is carried out by a collection and analysis of     synovial tissues for patients without inflammatory joint diseases compared to the experienced     equivalent biopsies from patients with inflammatory joint diseases.   "
63235|NCT02458157|"     The objective of this pilot trial is to assess the feasibility of forced fluid removal in     patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid     overload. The intervention will use furosemide infusion and/or continuous renal replacement     therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention     will be compared to standard of care as reflected in the kidney disease improving global     outcome (KDIGO) guidelines.   "
63236|NCT02458144|"     Aim of the present investigation is to analyse the amount of muscle trauma in relation to the     surgical approach and to the individual postoperative functional recovery. The investigation     will compare the MIS (minimally invasive surgery) anterior approach with the MIS     anterolateral approach to the hip.   "
63237|NCT02458131|"     The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a     disproportionate increase among minority youth. The research proposed in this Career     Development Award will use community-based participatory research methodology as well as     novel strategies (peer education and mobile health technologies) to design, implement and     evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban     community with high disease burden.   "
63238|NCT02458118|"     The purpose of this study is to assess pancreatic perfusion in patients with chronic     pancreatitis at rest and after secretin stimulation and compare this to published data on     pancreatic perfusion in normal subjects.   "
63242|NCT02458066|"     Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout     Bioko Island to be sprayed with either a long lasting pyrethroid insecticide, K-Othrine SC     62.5, or a bendiocarb insecticide, FICAM. Parasite prevalence in children aged 2-14 was     measured before and after the application of insecticide.   "
63243|NCT02458053|"     The purpose of this study is to determine the effect of a spousal support enhanced weight     loss program on weight loss among African American men.   "
63244|NCT02458040|"     This study is a meta-epidemiological study which aim is to quantify the clinical benefit of     the biomarker-based strategy compared to conventional strategy across all drugs with such a     strategy.   "
63245|NCT02458027|"     The objectives of this trial are to investigate whether the effects of hemp protein on     glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin     and appetite for one hour following consumption, 2) blood glucose, insulin and appetite     following a fixed energy meal to determine the second meal effect of hemp protein versus     soybean protein and a non-protein control.   "
63246|NCT02458014|"     The goal of this clinical research study is to learn if Blinacyto (blinatumomab) can help to     control ALL with positive MRD. The safety of this drug will also be studied.   "
63256|NCT02457871|"     The specific study aims are to: 1) examine differences between an Ecological Nursing Case     Management (ENCM) treated group and a comparison group on self-efficacy, SM behaviors, and     health status to establish effect sizes needed for a future large randomized controlled     trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3)     examine moderating effects of gender and perceived stress on the intervention effect. This is     a two-group randomized experimental study with repeated measurements. Clients in the     treatment group (n=25) will receive the individualized ENCM and those in the comparison group     (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months     to capture the immediate, short and longer term effects of the intervention.   "
63247|NCT02458001|"     Women affected by gynaecologic cancers are often not aware of sexual consequences of cancer     and its treatment. Most do not receive appropriate advice or help to recover sexual function,     and the impact on their sexuality may be profound. Despite this several potential therapies     can be effective in helping recovery. A major challenge is informing and involving the     patients in an appropriate and sensitive manner, and a further issue is the delivery of such     therapies in busy and medically driven gynaecologic oncology clinics. It will use and adapt     existing evidence based therapies for improving sexual function after cancer treatment and     develop a model for delivering these in the NHS (United Kingdom National Health Service)     setting. The model of 'stepped care' is adapted from that used nationally and successfully in     the Increasing Access to Psychological Therapies (IAPT) programme. Assessment allows for     'stepping up and down', i.e. calibrating the type of help a woman receives according to need     and her response to treatment already given.This study will develop and evaluate a 'stepped'     system of interventions using elements of best available evidence, adapting existing     interventions to help women recover their sexual feelings and activity, starting with simple     methods, moving on to new talking treatments for more complex cases. The investigators     address all gynaecologic cancers on the principle that sexual difficulty is the problem the     investigators are treating, not the cancer of origin. Ongoing clinical assessment will be     vital for the success of the stepped care model. The investigators will deliver training and     supervision to enhance the skills needed by the Clinical Nursing Specialist (CNS). An     important part of this study will be characterising the range of women and their willingness     to participate in psychosexual help. One-to-one follow up interviews will inform the level of     input required for any subsequent Randomised Control Trial (RCT). The investigators will use     internationally recognised rating scales for rating sexual function, assess how illness and     treatment affect mood and self esteem. The investigators will also measure the overall     cost-effectiveness to the public sector of providing this treatment, compared to costs of     subsequent use of health and social services. This pilot study will assess the feasibility of     conducting a full scale investigation of a stepped therapy and indicate the potential     benefits to the patients, their partners, and to the NHS generally.   "
63248|NCT02457988|"     A prospective series comparing care incorporating home monitoring and liver care coordination     to conventional care for patients with cirrhosis.   "
63249|NCT02457962|"     To collect and analyze specimens that will correlate with clinical outcomes such as acute and     late toxicities, quality of life, local control, and survival of patients treated with     photon/proton therapy.   "
63250|NCT02457949|"     This study evaluates whether altering the timing and frequency of social assistance     disbursement reduces drug related-harms that increase on the days surrounding monthly     synchronized government social assistance cheque issue.   "
63251|NCT02457936|"     Depression one of the leading causes of disability worldwide. Individuals suffering from     depression typically exhibit impairments in various mental abilities, such as the ability to     effectively direct and control attention and the ability to switch between thinking about     different things and concepts (commonly referred to as cognitive flexibility).      Mindfulness meditation training is a technique which involves focusing one's awareness on the     present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily     sensations. It has been well documented to improve depressive symptoms and prevent recurrence     of depressive episodes, yet little is known about how mindfulness does so and what are the     underlying mental mechanisms involved. Here the investigators propose to examine the efficacy     of an 8-week mindfulness training program in improving the ability to direct and control     attention, as well as in cognitive flexibility.      Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training     program. Participants' depressive symptoms as well as their performance on measures of     attention and cognitive flexibility will be examined. Participants will be assigned to     mindfulness training or a wait-list control group. Half of the participants will be examined     before and after the mindfulness training program and the other half will be tested 8-weeks     apart and then begin their training.   "
63252|NCT02457923|"     Using a community-based, cluster randomized controlled trial design (cRCT) the investigators     will examine the impact of an integrated m-health package -(M- SAKHI) for mothers on     appropriate infant feeding practices, starting in the first / second trimester of pregnancy     to 24 months after delivery, to improve child feeding practices and child growth, and reduce     the prevalence of undernutrition in their children. This will result in two treatment groups.     The clusters for the trial will be villages under the administrative area of ASHAs     (Accreditated Social Health Activists). Villages with a population of 1000- 2000 (ranging     from 751 to 2000) with 1 ASHA will be randomized to receive intervention (intervention     villages) or continue existing delivery of care (control villages). The data will be     collected using a longitudinal design because the investigators want to study the impact of     intervention on the mothers starting at pregnancy until her infant is 24 month old.   "
63419|NCT02455544|"     The aim of the study is to validate in a prospective fashion the value of the Congo-Red Dot     (CRD) test for diagnosis of preeclampsia. The working hypothesis is that in pregnancies     complicated by preeclampsia, will display urine congophilia and have a positive CRD test.   "
63253|NCT02457910|"     This partially randomized phase Ib/II trial studies the side effects and best dose of     taselisib when given together with enzalutamide and to see how well they work in treating     patients with androgen receptor positive triple-negative breast cancer that has spread to     other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is     cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the growth     of tumor cells by blocking the androgen receptor from working. Giving taselisib with     enzalutamide may be a better treatment for patients with breast cancer.   "
63254|NCT02457897|"     Background:      - Insulin receptor mutation causes high blood sugars and sometimes diabetes complications.     Researchers want to see if thyroid hormone helps.      Objectives:      - To see if thyroid hormone treatment changes how the body handles sugar in people with     insulin receptor mutation and improves blood sugar in people with diabetes.      Eligibility:      - People ages 12 65 with an insulin receptor mutation.      Design:        -  Study part 1:19-day clinic stay. Participants will be monitored for 4 days. Then for 15          days they will take a thyroid hormone pill 3 times a day. Participants will have:        -  Blood tests.        -  Heart rate and skin temperature monitored.        -  All their food provided.        -  Two 5-hour sessions in a special room. They will wear special clothes and sometimes sit          still.        -  Two small tubes inserted in veins. One will deliver tiny amounts of sugar and fat with a          non-radioactive tracer. Participants will also drink water with a tracer. The other tube          will collect blood.        -  A sweet drink. Participants may have finger stick blood sugar tests.        -  Glucose-monitoring device inserted into body fat for two 24-hour periods.        -  Adults may have samples of fat and muscle taken.        -  Heart ultrasound.        -  PET-CT scan in a machine. An intravenous catheter will be placed in an arm vein. A small          amount of radioactive substance will be injected.        -  DEXA scan of body fat and bone density.        -  Participants with poorly controlled diabetes will then take thyroid hormone at home for          6 months. They will have blood drawn and sent to the study team monthly.        -  After about 3 months, they will have an overnight visit. After 6 months, they will have          a 4-day visit.   "
63257|NCT02457858|"     In this study, the investigators hypothesize that the addition of antioxidant BMX-010 to     perfusion solution, digestion solution and culture medium during islet isolation process, can     lead to greater preservation of islet mass and metabolic function, such as improved islet     yield, viability, and functional potency.      This pilot study will involve up to 10 participants from the islet transplant waiting list at     the Clinical Islet Transplant Program. All participants will receive islets isolated with the     medication BMX-010. This is to assess the primary safety of BMX-010 on pancreata and islets.     BMX-010 will be used only in the islet isolation process, and will not be given to     participants as medication.   "
63258|NCT02457845|"     This study is a clinical trial to determine the safety of injecting G207 (a new experimental     virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207 with     a single low dose of radiation, designed to enhance virus replication and tumor cell killing,     will also be tested. Funding Source - FDA OOPD   "
63259|NCT02457832|"     The purpose of this research study is to learn more about brain activity when individuals     with and without Parkinson disease (PD) move their lower limbs. The investigators also want     to see if and how two different types of partnered dance affect brain activity in individuals     with and without PD. Testing will take place at the Atlanta VA Medical Center and at Emory     University. The investigators expect to enroll about 140 people for this study over a     five-year period.   "
63260|NCT02457819|"     This is an open label 26 week extension study for subjects who completed SEP360-202.   "
63261|NCT02457806|"     To compare the efficacy of Kovacaine Mist administered bilaterally to that of Kovacaine Mist     administered unilaterally with respect to global profound pulpal anesthesia in target teeth     numbers 4-13.   "
63262|NCT02457793|"     This is a two-stage dose-escalation study to assess the safety, tolerability and effects of     oral dosing of cobimetinib and GDC-0994 administered in combination in patients with     histologically confirmed, locally advanced, or metastatic solid tumors for which standard     therapies either do not exist or have proven ineffective or intolerable.   "
63263|NCT02457780|"     Many responders to the World Trade Center (WTC) disaster continue to experience significant     mental and physical health problems. Two of the most common health problems, post-traumatic     stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health     conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The     primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and     respiratory symptoms.   "
63264|NCT02457767|"     In this study the investigators measure and optimize the patients waiting time in the     preanesthetic assessment by integrating an interactive mobile device. The aim of this study     is to observe whether the patients mean waiting-time is reduced by the use of a special     mobile application (Anaest-App) and, as a result , raises patient-satisfaction.   "
63265|NCT02457754|"     Several studies have shown a high association between physical fitness and present and future     health. Two of the main epidemics of the industrialized world are obesity and osteoporosis,     diseases that could be prevented with early interventions from childhood. Both, physical     activity and physical fitness have shown an association with these diseases, but tools for     assessing them in early ages are still in development. Moreover, there is a lack of physical     fitness reference values in preschool children and the relation of pathologies with physical     fitness in these ages is still to be demonstrated. Therefore, through a simple and precise     methodology displayed in the school and adapted for the younger we intend to: Provide a     combination of safe and precise field tests to evaluate health related physical fitness in     preschool children. Analyze body composition, risk of overweight, obesity and low mineral     density and their relation with physical activity. The evaluation of these health-related     physical fitness variables in early ages is of great interest to clinic and public health.   "
63266|NCT02457741|"     This study will test the validity of a new approach to assess alveolar recruitability at the     bedside in comparison to direct measurements of lung volume and derecruitment.   "
63267|NCT02457728|"     Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.   "
63268|NCT02457715|"     This is a parallel group, single institution, prospective clinical study. The purpose of this     study is to assess whether the Jawbone Up 24, a consumer based accelerometer, can be a     feasible tool to study physical activity in cancer patients and patients with Amyotrophic     Lateral Sclerosis (ALS).   "
63269|NCT02457702|"     The researchers will recruit patients with liver disease at Parkland Hospital. Patients will     fast overnight, and the next morning will receive an oral mixture of [U-13C3]glycerol (25     mg/kg) plus unlabeled glycerol (25 mg/kg). The total dose of glycerol will be 50 mg/kg in 100     milliliters of water. The taste is slightly sweet. Blood will be drawn at 60 min and 120 min     after the ingestion. Blood glucose will be isolated and analyzed by NMR. The presence of     [5,6-13C2]- and [4,5-13C2]glucose indicates preserved mitochondrial function. The researchers     anticipate that patients with severe liver disease will show a decrease in mitochondrial     function and will inform biosynthetic function of liver mitochondria.      After the first 6 successful exams (see power analysis, below), healthy volunteers (age-,     gender-, and race-matched) will be studied at the AIRC and subject to the same protocol.   "
63277|NCT02457598|"     This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics,     and preliminary efficacy of tirabrutinib (ONO/GS-4059) in combination with other targeted     anti-cancer therapies in adults with relapsed or refractory B-cell lymphoproliferative     malignancies.      This study consists of two parts: Dose Escalation and Dose Expansion. During the dose     escalation phase, participants will be sequentially enrolled in a standard 3 + 3 dose     escalation study design, to receive oral tirabrutinib combined with idelalisib entospletinib     +/- obinutuzumab. The Dose Expansion Phase will enroll additional participants with a single     B-cell lymphoproliferative malignancy disease type to further evaluate efficacy, safety,     tolerability, PK, and pharmacodynamics.   "
63278|NCT02457585|"     Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.      This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled     patients will be 11   "
63573|NCT02453490|"     This study is a multicenter ,randomization, open control study to evaluate the efficacy and     safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the     peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).   "
63270|NCT02457689|"     CUT*HIVTHER 001 is a randomised placebo-controlled Phase I/II study aimed at exploring the     safety and immunogenicity of two different modes of delivery of a GTU® DNA plasmid vaccine     (GTU®-multiHIV B clade) in HIV infected volunteers on antiretroviral therapy (ART):        -  Transcutaneous (TC) delivery to enhance intramuscular delivery and        -  Electroporation (EP) enhanced intramuscular delivery Participants will be randomised          1:1:1 to TC:EP:saline for the purposes of analysis. Half the saline group will receive          TC saline and half will receive EP saline.           30 HIV infected male and female volunteers aged 18-45 years, who have been on ART for at          least 6 months with 2 or more HIV plasma viral load measurements < 50 copies HIV RNA/ml          prior to enrolment.      The investigational HIV-1 vaccine GTU®-MultiHIV B clade encodes for a MultiHIV antigen which     is a synthetic fusion protein consisting of full-length polypeptides of Rev, Nef, Tat, p17     and p24 and containing more than 20 Th and CTL epitopes of protease, reverse transcriptase     (RT) and gp160 regions of the HAN2 HIV-1 B clade.      Vaccine is provided in sealed vials at 2mg/ml, and a single 1ml IM injection of 2mg     GTU®-MultiHIV DNA IM (into the thigh) is required to deliver a 2mg dose. Individuals in Group     2 will receive a further 0.4mg GTU®-MultiHIV DNA in 0.2ml administered by TC, a novel     needle-free method of vaccine delivery.   "
63271|NCT02457676|"     This study on children with fetal alcohol spectrum disorder (FASD) aims to (i) characterize     their self-regulation deficits, a process important for controlling emotions and behavior,     (ii) describe brain structure and function underlying self-regulation, and (iii) determine     whether training to improve self-regulation abilities changes brain and behavior. Individuals     with FASD have a high risk of cognitive and social deficits, which reflect their difficulties     in self-regulation and may lead to mental health concerns in adulthood. Importantly, early     intervention improves long-term outcome. However the full extent of self-regulation problems     in FASDs is unknown and the underlying neuroanatomy has not been fully described.     Furthermore, information on how to best treat children with FASDs is lacking. Thus, the     investigators propose three studies with a sample of 8-12 year old children, 40 with FASDs     and 20 typically developing controls. In Study 1, the participants will be evaluated on     cognitive and social self-regulation abilities using clinical and experimental tests. In     Study 2, the participants will undergo a 1-hour MRI scanning session to obtain measures of     their brain structure and function. In Study 3, FASDs will be randomly assigned to an     immediate or delayed treatment group. The immediate group will undergo 12-weeks of therapy     with the Alert Program for Self Regulation®. On conclusion of training, all will repeat     Studies 1 and 2 and following this retest, the delayed treatment group will undergo training.     The investigators will evaluate change in cognitive and social behavior and in brain     structure and function by comparing performance and neuroimaging findings before and after     the intervention. The investigators expect Alert training to significantly improve behavior     and alter brain regions important for self-regulation. The findings will yield important     information for improving self-regulation in FASDs and mitigating the development of mental     health challenges.   "
63272|NCT02457663|"     In this prospective, multi-center study, 200 patients from four participating Texas burn     hospitals will be enrolled from admission to discharge. The clinical research study team will     collect approximately 11 serum samples and clinical data related to sepsis and infection     predictors from severely burned adult patients, ages 18-80 years old. All serum samples from     participating sites will be shipped to the lead site, University of Texas Medical Branch. The     University of Texas Medical Branch will then validate previously identified biomarkers while     simultaneously identifying novel biomarkers through discovery proteomics.   "
63288|NCT02457247|"     The purpose of this study is to compare the preference of Calcichew D3 500/400 (containing     500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600 mg of calcium     and 400 IU of vitamin D) in Test Group 1, and to compare Calcichew D3 500/800 (containing 500     mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500 mg of calcium and     800 IU of vitamin D) in Test Group 2.   "
63300|NCT02457091|"     The purpose of this study is to test different types of exercise training for people with     multiple sclerosis (MS). The exercise program is based on physical activity guidelines that     have been developed specifically for people with MS. The investigators believe these     guidelines will be effective for improving physical fitness and function in persons with     mild-to-moderate MS.   "
63301|NCT02457078|"     This project will investigate whether adding nutritional supplements to the diet will have     beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of     age). The nutritional supplement will contain lutein (typically found in leafy     vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such     as salmon or tuna), and of vitamin E.   "
63273|NCT02457650|"     Background:      Autologous T cells engineered to express a T cell receptor (TCR) targeting NY-ESO-1 will be     infused back to patients with NY-ESO-1- expressing malignancies. The patients pretreated with     a lymphodepleting preconditioning regimen will be monitored after infusion of anti-NY-ESO-1     TCR-transduced T cells for adverse events, persistence of anti-NY-ESO-1 TCR-transduced T     cells and treatment efficacy.      Objectives:      To evaluate the safety and the efficacy of anti-NY-ESO-1 TCR-transduced T cell-based     immunotherapy for patients with NY-ESO-1- expressing malignancies.      Eligibility:      Patients older than one year of age, who have relapsed or refractory malignancies that     express both NY-ESO-1 and human leukocyte antigen (HLA)-A2 molecules.      Patients must have adequate organ functions.      Design:        -  Peripheral blood from patients will be collected for isolation of peripheral blood          mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral          vector encoding an HLA-A2 restricted anti-NY-ESO-1 TCR gene.        -  Patients will receive a lymphodepleting preconditioning regimen to prepare their immune          system to accept modified T cells.        -  Patients will receive an infusion of their own modified T cells. They will remain in the          hospital to be monitored for adverse events until they have recovered from the          treatment.        -  Patients will have frequent follow-up visits to monitor the persistence of modified T          cells and efficacy of the treatment.   "
63274|NCT02457637|"     Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute     deterioration of liver function, culminating in multiple organs failure and high short-term     mortality. Currently, there are differences in definitions and descriptions between western     and eastern types of ACLF, especially in the definition of chronic liver disease and its     precipitating events. The CANONIC (EASL-CLIF Acute-on-Chronic Liver Failure in Cirrhosis)     study put forward CLIF-SOFA (chronic liver failure-sequential organ failure assessment)     scores as the clinical diagnostic criteria of ACLF in 2013. Although the Asian Pacific     Association for the Study of the Liver (APASL) reached a consensus for diagnostic criteria of     ACLF in 2008, which is however based on expert opinion, rather than prospectively collected     and validated data. To clarify the eastern type of ACLF (HBV related) and establish whether     the eastern and western (alcoholic related) types of ACLF are homogenous, the investigators     are launching this prospective multicenter clinical trial. The investigators are going to     identify three key points: (1)Whether HBV and non-HBV ACLFs are belong to a homogenous     disease entity which share the same diagnostic criteria, disease grades classification and     prognostic model; (2) Whether acute deteriorating patients from cirrhosis or from mild     fibrosis (S1-S2) belong to a homogenous entity? (3)To clarify if there are heterogenous     groups in APASL criteria diagnosed ACLF patients.      13 Chinese national wide liver centers each of whose total beds are around 500 have been     included. Extra liver centers may join later. Continuous hospitalized chronic liver disease     patients of various etiologies (including both cirrhotic and non-cirrhotic) with acute     decompensation (AD) or acute hepatic injury (ALI) (aminotransferase > 3NL(normal level)) will     be recruited from January to December 2015. Biochemical parameters, organ failure, mortality     and liver transplantation rate will be collected and evaluated at day 1,4,7,14,21 and 28     after enrollment. Considering there will lack of liver biopsy in most of the patients, both     CT and FibroScan as supplementary methods will be used for differentiating non-cirrhotic     patients, especially hepatitis patients with mild fibrosis, from cirrhotic patients. The     patients will be continuously followed up once a month until the 24th month after hospital     discharging. During follow-up, patients will be hospitalized again whenever they have new ALI     or AD. Similar data will be collected reference to their prior admission and follow-up will     restart. Through continuous collection, the investigators will acquire data about the     patients from stable chronic liver disease to deterioration of the disease. Then these data     will be analyzed according to the questions that the investigators hope to resolve.   "
63275|NCT02457624|"     Experienced endoscopists will perform endoscopy during the study period and the detection     rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis     of premalignant lesions and inter-observer agreement rate will be analyzed before and after     the education.   "
63276|NCT02457611|"     The primary objectives of this study are to determine the antiviral efficacy, safety, and     tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with     acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus     (HIV)-1 co-infection.   "
63282|NCT02457325|"     The present clinical trial randomized compared the clinical efficacy of the local anesthetics     articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the     removal of lower third molars. Onset, duration of postoperative analgesia, duration of     anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters,     postoperative mouth opening and wound healing at the 7th postoperative day were evaluated.     For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower     third molars, in two separate appointments (one to two months apart), under local anesthesia     with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized     and crossed manner.   "
63283|NCT02457312|"     The present study aims at studying the effect of letrozole in early pregnancy in placenta and     decidua including the progesterone receptor and the apoptotic factors.   "
63284|NCT02457299|"     This multi-center, randomized prospective clinical trial involves esophageal cancer patients     who are surgical candidates. Patients will be randomized either to the one stage or the two     stage esophagectomy procedure. Surgical, oncology outcomes, quality of life and cost analysis     from both types of procedure will be reviewed and compared.   "
63285|NCT02457286|"     Metformin is being compared to exercise and diet modifications. The researchers are     interested in learning if the addition of metformin to lifestyle modifications is more     helpful in treating the condition or disorder. Although metformin is FDA approved to treat     type 2 diabetes, it is not FDA approved for the treatment of Non-alcoholic fatty liver     (NAFLD) and is considered investigational for the purpose of this study.   "
63286|NCT02457273|"     Title of Study:      An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy     and Safety of TLC388 as Second-line Treatment in Subjects with Poorly Differentiated     Neuroendocrine Carcinomas      Investigational product:      Lipotecan®*      *Lipotecan® is the trade name of TLC388 HCl, a Topoisomerase I inhibitor)      Phase of development:      Phase II      Number of subjects:      Plan to enroll 44 subjects      Objectives:      Primary objectives:      To determine the objective response rate      Secondary objectives:      To evaluate Disease control rate, Progression free survival, Overall survival, Safety profile     and Biomarkers   "
63287|NCT02457260|"     Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in     skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady     state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational     new drug (IND) approved sodium nitrite (10 milligram [mg]) capsule, and its utility to     upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP) pathway of     skeletal muscle of younger heart failure (HF) patients. It now seems exceptionally logical     and opportune to apply these insights to older HF patients and to delineate mechanisms of     disease and aging that respond to nitrite therapy.   "
63289|NCT02457234|"     The purpose of the Traditions study was to examine the influence of cultural immersion on     willingness to try fruits and vegetables among children, 3-12 y, in Guam. The primary     objective of this study was to examine willingness to try fruits and vegetables and fruit and     vegetable intake among children attending three existing summer camp programs: a cultural     immersion camp, a university day camp, and a recreational sports camp. The primary hypothesis     was that children attending the cultural immersion camp would have higher willingness to try     fruits and vegetables (WillTry score) and a higher intake of fruits and vegetables compared     to children attending both, the university day camp and recreational sports camp, without     cultural immersion.      A pre-post, quasi-experimental design was used to evaluate 3 summer camps with different     exposure levels of cultural immersion. High, moderate, and zero (cultural) exposure was     provided by a cultural immersion camp (CIC), a university-based day camp (UDC), and a     recreational sports camp (RSC), respectively. CIC delivered 4 culturally adapted nutrition     lessons within the context of Chamorro cultural traditions as part of the cultural immersion     camp activities. The UDC delivered the same lessons within a physiology framework. The RSC     was without nutrition lessons and cultural immersion. Children 3-12 years old registered in     any of the three summer camp programs were eligible to participate. Data collection was     primarily administered at two assessment periods: before (± 2 weeks) and after (± 1 week)     each summer camp program. Children's willingness to try fruits and vegetables, the primary     outcome, was assessed with the interview-administered Adapted WillTry tool. The secondary     outcome was fruit and vegetable intake as servings/day in the CIC to UDC only. Fruit and     vegetable intake was assessed using the mobile food record (mFR), which is an app running on     an iPod Touch based on the technology assisted dietary assessment (TADA) protocols. Outcomes     examined Adapted WillTry post-scores for local novel and local common fruits and vegetables     and fruit and vegetable servings/day using multivariate regression models adjusting for the     relevant pre-score, sex, age, ethnicity, dose, BMI percentile, and parent's cultural     affiliation. Therefore, additional measures like sociodemographic information, anthropometry     (i.e. heights and weights), and parent's cultural affiliation were collected to account for     potential confounders.   "
63290|NCT02457221|"     The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for     induction remission in patients with lupus nephritis, and compare the efficacy and safety     with Cyclophosphamide injections.   "
63291|NCT02457208|"     This is a prospective descriptive and pharmacokinetic study will be conducted among newly     diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border.     This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV     co-infection in one year. Patients will be given the standard 6 month anti-TB drugs as per     WHO guidelines.   "
63292|NCT02457195|"     The objective of the study is to evaluate the efficacy and safety of adding transdermal     preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting     (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the     previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing     surgical procedure under general anesthesia.      The specific aims of the study include:        1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery        2. incidence and seriousness of the observed side effects        3. ability of patients to self-administer preoperatively and maintain the investigated          patch during the perioperative period        4. level of satisfaction with the preoperative PONV prophylaxis.   "
63293|NCT02457182|"     Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood disease with     unreliable treatments. Although it is not known what causes it for certain, we do know that     life stressors may make the disease worse or cause flares. Mindfulness Based Stress Reduction     (MBSR) is an 8 week class focused on meditation and other techniques that the investigators     think may be helpful to people with IC/BPS. This trial will assign participants to an MBSR     class or usual care for their IC/BPS to see if the MBSR class would be helpful for their     disease.   "
63294|NCT02457169|"     The intervention under examination is designed to promote parents' school engagement     following the transition from Early Intervention (EI) to preschool for parents of young     children who were diagnosed with ASD through our screening and assessment protocol. The brief     intervention employs principles of motivational interviewing to address not only the     particular child characteristics and needs associated with ASD but also the unique,     system-related challenges of navigating the special education system and advocating for     appropriate services. Motivational interventions with parents are designed to elicit parents'     specific, action-oriented goals for themselves and their children, enhancing motivation to     pursue change, and addressing and resolving obstacles or sources of ambivalence.      By identifying and capitalizing on parents' strengths, empowering parents to develop specific     goals, and improving parents' readiness to engage actively with their children's school,     teacher, and educational team, we expect that this brief intervention will lead to higher     levels of parental school involvement, higher special education engagement, and closer and     more productive parent teacher relationships.   "
63295|NCT02457156|"     The purpose of this study is to compare two different techniques of performing a pancreatic     anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces     pancreatic remnant leak, post-operative complications and overall length of hospital stay.   "
63296|NCT02457143|"     This randomized trial aims to understand how effective a reminder letter is compared to a     reminder phone call in improving breast, cervical and colorectal cancer screening rates and     reducing screening disparities.   "
63297|NCT02457130|"     Patients with type 2 diabetes mellitus (T2DM), have a high prevalence of suboptimal response     to clopidogrel (up to 40%). This impaired response to antiplatelet drugs has been     consistently associated with a higher risk of adverse ischemic outcomes. Different strategies     have been suggested to overcome variability in response to clopidogrel and improve clinical     outcomes in diabetic patients. One of these strategies is the use of newer P2Y12 inhibitors,     such as ticagrelor, with more potent and consistent platelet inhibitory effects compared to     clopidogrel. In summary, since patients with T2DM continue to have enhanced platelet     reactivity despite the administration of commonly used dual antiplatelet therapy with aspirin     and standard doses of clopidogrel, newer and more potent antiplatelet treatment strategies     are warranted in this high-risk population. The purpose of the present study is to compare     platelet inhibitory effects achieved with ticagrelor versus clopidogrel, both on top of     aspirin therapy, in patients with type 2 DM and stable coronary artery disease.   "
63298|NCT02457117|"     This study is a registry to monitor quality of life and clinical outcomes in patients with     clinically localized breast cancer who have received stereotactic accelerated partial breast     irradiation via CyberKnife.   "
63299|NCT02457104|"     The investigators long-term goal is to understand how PPIs influence energy balance in both     obese and normal-weight individuals. The overall goal of this study is to determine whether     PPI use causes detrimental changes in the composition and functional properties of the gut     microbiome, and whether any such effects are mediated by altered responses of human fatty     acid receptors (e.g., GPR41/43).   "
63335|NCT02456636|"     The purpose of this study is to compare three methods for managing obesity in rural patients,     to see which method will result in patients being able to attain their weight loss goal and     maintain that weight loss.   "
63302|NCT02457065|"     A patient's sun-related behavior greatly influences the likelihood of that patient developing     melanoma, the most dangerous form of skin cancer. Prior research shows current education     strategies on inducing preventative behaviors such as wearing sun-protection clothing and     wearing sunscreen are inadequate at effectively changing behavior when used in isolation --     patients are aware of the dangers of not engaging in these preventative measures but forgo     them nonetheless.      We are investigating methods to positively influence sun protection behaviors among melanoma     survivors and their families. The first objective is to compare patient and familial sun     exposure and cancer screening activity before and after patients' diagnosis with primary     melanoma. The second objective is to note if hanging a Melanoma Survivor plaque in a     melanoma survivor's bathroom will significantly affect the survivor's and broader family's     sun exposure and cancer screening activity.      Our sample of patients consists of survivors of primary cutaneous melanoma less than 4.0 mm     in depth who come through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and     voluntarily choose to participate in the study after being informed of the nature of the     research. These patients complete a confidential survey assessing a change in sun exposure     related activities immediately after their diagnosis. After they fill out the survey, we will     ask them if they could nominate a family member to whom we will explain the purpose of our     research and confidentially ask an additional set of questions to evaluate the broader impact     of a melanoma diagnosis. From our original sample, we will randomly choose a few families who     would display the survivor plaque in their primary bathroom. After six-twelve months, during     the patient's follow up visit, will ask again both groups of patients and family members to     fill out another survey to assess sun exposure related activity.      On the surveys, no names are recorded. Everything is anonymous.   "
63303|NCT02457052|"     When the seat is a vehicle for disabled person, postural adaptation methodology is known and,     on prescription, there is possibility of financial support for technical posture assists. For     people who use a standard seat, a chair for example, there is no satisfactory existing     hardware.      A transportable customisable and scalable sitting positioning device (DATP device), to be     placed on a standard seat, is a solution that might fit in the home, in specialized foster     homes or in institutions for the elderly. Such a device has been developed but earnings on     swallowing disorders have to be validated.   "
63316|NCT02456883|"     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in     particular, the routes of excretion and extent of metabolism of gilteritinib following     administration of a single dose of 14C-labeled gilteritinib after repeated doses of     gilteritinib.      This study will also evaluate the safety of repeated oral administration of gilteritinib in     subjects with advanced solid tumors as well as identify the metabolic profile of gilteritinib     in plasma, urine and feces after a single oral dose of 14C-labeled gilteritinib.   "
63317|NCT02456870|"     The purpose of this pilot study is to determine whether adipose tissue loses some of its     ability to expand in response to overfeeding in older compared to younger men. The     investigators hypothesize that the adipose tissue response to overfeeding may be weakened in     older when compared to younger men, thereby leading to worsened ectopic storage depots for     older men.   "
63304|NCT02457039|"     Chemobrain is an expression used to describe a cluster of chemotherapy-induced cognitive     impairment symptoms, including problems with visual and verbal memory, forgetfulness,     difficulty in learning, attention, concentration and coordination of multitasking and     organization. Over 75% cancer patients experienced acute cognitive symptoms during     chemotherapy and 17%-34% of them have long-term post-treatment cognitive deficits which can     persist up to 10 years. Breast cancer survivors even display as high as 50%-75% prevalence of     post-treatment cognitive impairment. Chemobrain has become an apparent quality-of-life issue     for cancer survivors and will be encountered more frequently with the rise of the number of     cancer survivors. There are no effective interventions available for preventing and treating     chemobrain.      Acupuncture is beneficial in reducing various side effects of anti-cancer treatment. It also     shows the efficacy in improving mild cognitive impairment and other dementia disorders;     facilitates the recovery of pathological microstructural changes of the brain. These results     have led to the hypothesis that acupuncture is effective in preventing chemobrain and this     preventive effect may be associated with the protection against cytokine production,     epigenetic modification and microstructural changes of the brain.      To test this hypothesis, an assessor-blinded, randomised controlled trial will be conducted     to determine if a combination of DCEAS and body acupuncture could reduce the incidence and     symptoms of chemobrain in breast cancer patients under chemotherapy compared to least     acupuncture stimulation (LAS) as controls.      A total of 168 breast cancer patients who are ready for chemotherapy will be randomly     assigned to comprehensive acupuncture intervention (combined DCEAS and body acupuncture     regimen + chemotherapy) (CAI) (n = 84) for 2 sessions per week for 8 weeks or least     acupuncture stimulation (LAS) (minimal acupuncture + chemotherapy) (n = 84). All patients     receive the standard chemotherapy of breast cancer. Treatment outcomes on cognitive     performance, fatigue and the depression will be assessed.   "
63305|NCT02457026|"     The purpose of this prospective interventional study is to assess whether adjunctive     verteporfin photodynamic therapy (PDT) is effective for the treatment of persistent disease     activity in neovascular age-related macular degeneration (NV AMD), as compared to anti-VEGF     therapy (aflibercept) alone. This study will enroll individuals with NV AMD who have     persistent disease activity in spite of either loading dose (initial 3-5 anti-VEGF     treatments) or maintenance (established course) anti-VEGF therapy to determine whether PDT     can improve disease activity, facilitate sustained visual acuity gains, and decrease burden     of frequent anti-VEGF treatments for affected patients. Risks of study are related to     treatment with study drugs: intravenous verteporfin, intravitreal triamcinolone acetonide,     and intravitreal aflibercept. All have been studied extensively in clinical trials and are     established treatments used routinely in NV AMD. Adverse events will be monitored by the     principal investigator and study team.   "
63306|NCT02457013|"     1. The purpose of the study is to evaluate prospectively the clinical benefits of High flow          nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure)          (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.        2. Design: non-inferiority study, prospective, controlled, randomized, multi-center.        3. Design: Infants less than 6 month admitted in pediatric intensive care unit for          respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical          ventilation will be randomized in two groups: n-CPAP(nasal continuous positive airway          pressure) or HFNC during 24 hours.        4. Conditions of measurements:           Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure          criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or          respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and          above 4) or apnea.           Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate,          EDIN score, skin lesions, FiO2 (fraction of inspired oxygen           ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2          (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 /          FiO2        5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142          children.        6. Study Schedule: October 2014-April 2016   "
63307|NCT02457000|"     The purpose of this study is to explore the mechanisms behind how sleep quality may affect     skin aging, skin integrity and skin disease.   "
63676|NCT02452151|"     The objective of this study is to compare the efficacy of Infliximab-Biosimilar to     Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative     colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.   "
63308|NCT02456987|"     This study is being conducted as a pilot to test the feasibility, usability, acceptability,     and clinical utility of using a virtual reality (VR) immersion experience in the inpatient     setting. In addition to determining whether the patients enjoy the experience and would like     to participate in a future more tailored immersion in virtual reality, we will be attempting     to determine whether there are any positive impacts on their visit, including a distraction     from their pain or anxiety associated with their procedures or the reason they have been     admitted to the hospital.      Because the inpatient population at Cedars-Sinai Medical Center (CSMC) is dynamic and     diagnostically diverse, we intend to develop a series of VR interventions that broadly     address patient concerns. VR has only been tested in select patient populations, so we are     equally interested in the feasibility of deploying VR across the inpatient hospital     environment as we are in demonstrating some effectiveness in reducing pain and anxiety, and     improving satisfaction.      The present study has the following aims:        1. Adapting existing VR environments for inpatients with a variety of impairments,          utilizing cost-effective VR hardware (Phase 1).        2. Assess the usability and acceptability of the VR equipment and software by hospital          inpatients by conducting qualitative interviews (Phase 2).        3. Assess the clinical utility of the VR intervention by measuring patient reported          outcomes using a modified care satisfaction survey, administered to inpatients receiving          VR and a matched control sample (Phase 3).      Concerning Aims 2 and 3, we hypothesize the following:        1. Inpatients will find the VR intervention helpful and enjoyable, and will believe that          its benefits outweigh any difficulties encountered using the hardware or software.        2. Inpatients who are exposed to the VR intervention will report significantly improved          pain management, greater satisfaction with their inpatient visit, and greater overall          health compared to matched control inpatients that were not exposed to VR.   "
63309|NCT02456974|"     Pharmacokinetics of antibiotics in critically ill neonates, infants and children   "
63310|NCT02456961|"     The standard CXL technique involves removal of the epithelium to enable riboflavin to     penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's     comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of     riboflavin is one of approach for riboflavin impregnation.      In this study, the investigators compared the results of standard corneal crosslinking (CXL)     and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.   "
63311|NCT02456948|"     This study examines the antidepressant efficacy of minocycline as an adjunct to an     antidepressant standard treatment with es-/citalopram, venlafaxine or mirtazapine monotherapy     (AD-ST), for patients with unipolar major depressive disorder (MDD).   "
63312|NCT02456935|"     The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD),     compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)     classification grades A to D at Week 8   "
63313|NCT02456922|"     The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in     subjects age 2 - 75 years   "
63314|NCT02456909|"     To examine whether providing patients with a cue to the availability of pain medication     affects patient satisfaction, patient anxiety, PCA efficacy, and safety.   "
63315|NCT02456896|"     The present study has been designed to evaluate the change in serum BDNF level with     oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its     neuroprotective effect.   "
63321|NCT02456818|"     This study aims to evaluate the impact of contact isolation on the rate of hospital-acquired     transmissions of ESBL-producing Escherichia coli (ESBL-EC) and the rate of colonization and     infection. On the basis of this study, it will be possible to re-evaluate the need for     contact isolation for patients colonized or infected with ESBL-EC.   "
63322|NCT02456805|"     This study assessed tolerance improvement of a formula change in healthy term infants with     perceived intolerance to their current milk-based formula feeding.   "
63323|NCT02456792|"     The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus     laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC)     resistant polycystic ovarian syndrome (PCOS).   "
63324|NCT02456779|"     The primary objective of this clinical study is to determine whether Peptest (Human Pepsin     lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic     methods commonly applied in clinical practice by testing a large number of clinical samples.      This will be performed by evaluating Peptest results in GERD patients (Erosive esophagitis or     NERD), defined using standard clinical procedures, and compared to healthy controls.   "
63325|NCT02456766|"     This will be a multi-center, prospective, controlled study. It is expected that about 240     subjects from 10 study centers will be enrolled, and 224 effective subjects will be     statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56     effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56     effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination     with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of     liver steatosis will be identified.      The patients with liver diseases who need to have a liver biopsy in hospital and meet all of     the inclusion criteria and none of the exclusion criteria, may participate in this study.     Within two weeks of FibroTouch examination, subjects are required to have qualified     histological specimens of liver biopsy for comparation.   "
63326|NCT02456753|"     The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can     help to visualize elements that may not be observable after clinical examination. Moreover,     it is known that a fetal head engagement can lead to an instrumental extraction and in case     of error, which happens in some cases, fetal and maternal risks are possible.      These elements led to the investigators' hypothesis which is that a trans-perineal     ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of     doubt.   "
63327|NCT02456740|"     Randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study     followed by active-treatment phase. To evaluate the effect of AMG 334 compared to placebo on     the change from baseline in monthly migraine days.   "
63336|NCT02456623|"     The purpose of this study is to preliminarily validate a parent-focused obesity intervention     program for parents of low-income, African American preschoolers who are currently overweight     (> 85th BMI %tile). Half of the participants will receive an intervention that is eight     sessions in length and carried out in the participant's home. The sessions will target the     nutrition and physical activity knowledge of parents and their motivation for changing     parenting related to family eating habits and activity level. The remaining participants will     receive an attention comparison control condition (ACCC), which includes one home visit, 7     newsletters and 4 monthly support phone calls. It is hypothesized that children of parents     receiving the intervention will have decreases in BMI %tile, consume more fruits/vegetables     and fewer sugary beverages, and engage in more activity as compared to ACCC.   "
63328|NCT02456727|"     Chronic pain is a major public health problem that places many burdens on individuals,     including impairment of physical and psychological functioning, lost productivity, and side     effects of medications used to treat pain. There is also substantial evidence that minority     populations differ both in prevalence and outcomes of chronic pain; access to care is a key     component in these differences. Strong evidence now supports the use of acupuncture in the     treatment of chronic pain conditions, including when provided in the primary care setting to     patients from ethnically diverse, medically underserved populations. Acupuncture is slowly     being integrated into pain management in many conventional health care settings, but cost and     reimbursement for this service remain obstacles to offering acupuncture, especially in     primary care and safety net settings. Because group acupuncture can be offered at much lower     cost, demonstrating that individual and group delivery are equally effective could reduce     barriers to use of this effective pain management approach.      The primary aim of this study will be to evaluate whether acupuncture delivered in the group     setting for patients with chronic pain is equal to acupuncture delivered in the individual     setting. A secondary objective will be to use qualitative analysis to understand and describe     the patient experience of both acupuncture approaches, and to utilize this data to inform     intervention delivery and dissemination, to better incorporate the patient perspective.   "
63329|NCT02456714|"     Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor     prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a     phase III clinical study, cisplatin plus gemcitabine is considered standard first-line     treatment in advanced cholangiocarcinoma patients, but there is no established second line     therapy.      Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX)     appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic     cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could     be an effective second-line treatment for patients with advanced cholangiocarcinoma.   "
63330|NCT02456701|"     This is a patient pilot study testing the hypothesis that vemurafenib with the addition of     KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR)     thyroid cancer patients.   "
63331|NCT02456688|"     This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in     patients with impaired hepatic function as compared to healthy volunteers.   "
63332|NCT02456675|"     A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy     and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or     refractory Hodgkin Lymphoma.   "
63344|NCT02456519|"     Provision of high-quality anaesthesia is a fundamental goal of all anaesthetic services.     Establishing whether this is being achieved requires validated measures of anaesthetic     outcomes but few of these exist, particularly for children.      QoR-15 (quality of recovery, 15 items) is a questionnaire that has been validated in adults     and assesses the quality of postoperative recovery from surgery. The investigators have     developed a modified version, the PaedQoR-15, that the investigators hope is capable of     performing the same task in children and young people. The principle aim of this study is to     assess whether PaedQoR-15 is a valid, reliable and clinically acceptable measure of the     quality of postoperative recovery in children and young people.      The investigators would also like to consider whether parent/guardian assessments of their     child's recovery correlate with self-reports. At Great Ormond Street a significant proportion     of children are unable to answer for themselves. If parent/guardian responses represent a     good approximation then this questionnaire may have a role in assessing the quality of     recovery in a population of children who are difficult to care for.   "
63333|NCT02456662|"     Background/Purpose of the Study Doxycycline is an antibiotic used for infection prevention     before surgical pregnancy termination, and a side effect of it is nausea/vomiting. The     investigators' study explores whether or not taking the anti-emetic ondansetron prior to     doxycycline decreases rates of nausea/vomiting. Patients enrolled in the investigators' study     will take either ondansetron or a placebo before they take doxycycline to see if ondansetron     decreases their nausea/vomiting. Reducing nausea/vomiting may prevent more infections, and     decrease the rates of general anesthesia, patient risks and hospital costs. Decreasing     nausea/vomiting will also improve patient experience.      Study Design This will be a randomized controlled trial. Data will be collected by     administrating surveys and a log where patients will record the timing of their medications     and episodes of nausea/vomiting. The primary outcome is nausea/vomiting after taking the     anti-emetic/placebo and doxycycline. 400 eligible patients will be enrolled over two years,     200 in the intervention group and 200 in the placebo group.      Rationale for Study Design A randomized controlled trial will be used to determine the     effects of the anti-emetic ondansetron on rates of nausea/vomiting.      Subject Characteristics Patients will be pregnant females, 18-45 years old, who are     undergoing surgical termination of pregnancy.      Design 1-2 days before the procedure, patients will complete a demographic questionnaire and     a survey about symptoms of nausea/vomiting. They will use a log to record symptoms they     experience between taking the anti-emetic/placebo and when they present for their procedure.     When patients come to the hospital, they will fill out a repeat survey rating their     nausea/vomiting.   "
63334|NCT02456649|"     The combination of breast conserving surgery (lumpectomy) with radiation therapy has been     shown to result in equivalent overall survival rates compared to mastectomy for the local     treatment of breast cancer. As a result, the majority of patients diagnosed with breast     cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple     studies have demonstrated the association between positive lumpectomy margins and an     increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation.     Studies report 20-40% of lumpectomy procedures result in one or more involved (positive)     surgical margins, leading to the need for further surgery, emotional distress, poorer     cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative     margin assessment techniques include specimen Xray, gross pathology, frozen section, and     touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune     Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative     assessment of the presence of tumor at the lumpectomy margin. In the current study, the     investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to     standard practice for intraoperative identification of tumor at lumpectomy margins, and its     ability to reduce positive margins and decrease the need for additional surgical procedures.   "
63337|NCT02456610|"     Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) cause significant morbidity and mortality     in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral drugs given     either prophylactically or as early therapy for patients with detectable viral loads appear     to be an effective strategy for reducing viral infections. However, long-term treatment with     these drugs is associated with significant toxicity, expense and the appearance of drug     resistant virus isolates ultimately resulting in treatment failure. CMV and EBV specific T     cells infusion to immunocompromised patients following HSCT is able to induce a successful     anti-viral response. The primary purpose of this study is to determine the safety and     efficacy of the infusion of CMV and EBV specific cytotoxic T cells (CTLs) for patients with     CMV and EBV reactivation or infection.   "
63338|NCT02456597|"     To investigate the function of a novel catheter for continuous peripheral nerve blocks in the     popliteal nerve: Two key issues are investigated 1) Successful primary placement and function     of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor     function following injection of local analgesics through the catheter; 2) The rate of     displacement after standardized movement of the limb where the catheter for continuous     peripheral nerve blocks is inserted.   "
63339|NCT02456584|"     This is a randomized, multi-center, parallel-group study to evaluate the pharmacodynamics     (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150     mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a     confirmed ovulatory baseline cycle.   "
63340|NCT02456571|"     This pilot study will explore the prevalence of expression of four immune checkpoint     biomarkers on circulating tumor cells (CTCs) from men with metastatic prostate cancer that     are captured by EpCAM via the CellSearch method, and specifically defined as co expressing     DAPI and cytokeratin, and lacking CD45 expression.   "
63341|NCT02456558|"     This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics,     and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.   "
63342|NCT02456545|"     Prospective multicentre observational study for treatment approaches in at-risk individuals.     Furthermore the purpose of this study is to test feasibility of a clinical staging model and     validate diagnostic tools to identify individuals at risk state for the development of BD.   "
63343|NCT02456532|"     This proposal will assess risks for transition from therapeutic hypnotic use to abuse in     people with insomnia. The investigators will study a hypothesized at-risk sub-population,     insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects,     eszopiclone, versus one without mood effects, zolpidem.   "
63346|NCT02456493|"     The patients who have undergone cardiac surgery have higher likelihood of postoperative     cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with     cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid     IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative     cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for     OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by preoperative     B-mode ultrasonography, and 50 patients who have coronary artery occlusive disease and do not     undergone the operation are recruited as non-surgical group. The cognitive function measured     by K-MMSE, MOCA-K before the operation, and on the 7 day, 3 months after operation. The     patients in the non-surgical group are measured three times: baseline, after 7days, after 3     months.   "
63347|NCT02456480|"     To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients     with mild to moderate atopic dermatitis (AD).   "
63348|NCT02456467|"     This study compares the results of current standard coagulation measurement devices to the     Quantra System, a new device, using small amount of extra blood obtained during routine blood     draws in cardiac surgery patients.   "
63349|NCT02456454|"     Controlled trial of the efficacy and safety of valproate, versus risperidone in children,     ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.   "
63350|NCT02456441|"     The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical     syndrome characterized by urgency with or without urge incontinence , usually accompanied by     frequency and nocturia , since in the absence of proven infection or other pathology related     . The negative impact on quality of life of patients with OAB is already known. The etiology     and pathophysiology of OAB are not completely understood. However, studies indicate an     alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of     OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as     a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way .     However, no studies in the literature evaluating the effect of electroconvulsive therapy on     the mechanisms involved in sympathetic and parasympathetic modulation in these women . The     objective of this study is to investigate the effects of TENS on the sympathetic and     parasympathetic system in women with OAB . This is a randomized, double -blind , which will     be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into 2     groups : TENS group and placebo group. Interventions take place in one day assessment of the     sympathetic and parasympathetic nervous system are performed . After collecting the data will     be analyzed in accordance with the statistical analysis.   "
63351|NCT02456428|"     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2     diabetes) taken either alone or in combination with other anti-diabetic drugs are associated     with an increased risk of heart failure (HF) compared to other combinations of oral     hypoglycemic agents (OHA).      The investigators will carry out separate population based cohort studies using     administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs     entered the market, with follow-up until hospitalization for HF. Analyses will be done     separately for groups of patients with and without prior HF. The results from the separate     sites will be combined to provide an overall assessment of the risk of HF in users of     incretin-based drugs and by class of incretin-based drugs.   "
63352|NCT02456415|"     This study evaluates the safety and efficacy of biodegradable magnesium alloy screw, in     patients with hand fractures who require internal fixation (to obtain a product license from     the Ministry of Food and Drug Safety in Korea (MFDS)).   "
63353|NCT02456402|"     This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare     Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery     lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of     bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS.     Endpoints are late luminal loss at 9 months, and major adverse cardiac events including     arterial thrombosis at 1, 9 and 12 months.   "
63354|NCT02456389|"     The primary objective of this trial is to determine if perioperative risk stratification and     risk-based, protocol-driven management leads to a reduction in the rate of death or serious     complications compared to standard perioperative management in patients undergoing elective     major cancer surgery.   "
63355|NCT02456376|"     The purpose of this study is to investigate how sensory information processing affects     balance ability in children with cerebral palsy (CP). An additional goal is to determine if a     subsensory electrical stimulation called Stochastic Resonance (SR) Stimulation, can improve     balance in children with CP. Children with CP and children with typical development will     participate and complete a series of clinical and balance assessments. They will also be     tested in a sensor fusion paradigm to investigate potential deficits in the dynamic     integration of visual, vestibular and proprioceptive information during upright stance. SR     stimulation will then be used to potentially improve these deficits and subsequently their     balance ability.   "
63356|NCT02456363|"     Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of     ankylosing spondylitis patient safety and efficacy.   "
63364|NCT02456259|"     The number of patients undergoing Minimally Invasive Cardiac Surgery (MICS) is increasing     each year. MICS procedures on atrioventricular valves are usually performed without     conventional sternotomy, an alternative approach is from right anterolateral minithoracotomy.     This surgical approach has essential impact both on anesthesia techniques and cardiopulmonary     bypass (CPB) settings. Specific anesthesiological procedure is an insertion of neck venous     cannula of CPB through the right internal jugular vein into the superior vena cava both for     partial and total bypass. The size of neck cannula is between 15 and 21 French depending on     the type of surgical procedure and patient's weight. Central venous catheter and eventually     sheath are also inserted into the right internal jugular vein. Thus, there is a relevant     question regarding postoperative patency of right internal jugular vein in patients     undergoing MICS procedures requiring an insertion of neck cannula of CPB. The investigators     hypothesize, there is no significant difference in postoperative patency of internal jugular     vein assessed by ultrasound in patient undergoing cardiac surgery with and without neck     cannula of CPB   "
63357|NCT02456350|"     Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) with a     safety switch will be infused back to patients with B cell malignancies, including lymphoma     and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T     cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment     efficacy.      Objectives:      To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for     patients with B cell malignancies.      Eligibility:      Patients between 1 and 85 years of age, who have relapsed or refractory CD19-expressing     B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.      Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria     are eligible to participate.      Patients must have adequate organ functions.      Design:        -  Peripheral blood from patients will be collected for isolation of peripheral blood          mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral          vector encoding anti-CD19 CAR containing a CD28 and a CD3 zeta as costimulatory domains          as well as a safety switch.        -  Patients will receive a lymphodepleting preconditioning regimen to prepare their immune          system to accept modified T cells.        -  Patients will receive an infusion of their own modified T cells. They will remain in the          hospital to be monitored for adverse events until they have recovered from the          treatment.        -  Patients will have frequent follow-up visits to monitor the persistence of modified T          cells and efficacy of the treatment.   "
63358|NCT02456337|"     The purpose of this study is to evaluate the reduction of gingival recession of single Miller     Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen     matrix graft and / or enamel matrix proteins.   "
63359|NCT02456324|"     The study is designed as a prospective, non-randomized clinical trial comparing safety and     effectiveness of the CuraSeal PICS-AF device to historical data from commercially available     devices for the treatment of anorectal fistulas.   "
63360|NCT02456311|"     VATS anatomical lung resection provides an effective minimally invasive treatment strategy     for stage I and II lung cancer. VATS lobectomy is associated with significantly less     postoperative atrial fibrillation, blood transfusion, renal failure, and other complications     when compared with lobectomy via thoracotomy.      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.     Complications include: pulmonary vascular injuries (PA, pulmonary vein) necessitating urgent     conversion to open thoracotomy and even death14. Causes of conversion included PA injury,     difficult anatomy, bulky/calcified lymph nodes, and technical problems including stapler     misfire. PA injury alone constituted 37.5% of all conversions. Proper dissection of all     tissue around PA branches is sometime difficult especially in the presence of adhesions or     large, calcified lymph nodes and may increase the risk of vascular injury.      Currently, in spite of being a safe and effective technique in experienced hands, a minority     of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the     Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung     resections were performed by VATS.      The technical difficulty and danger of VATS lobectomy is directly related to PA branch     manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic     surgeons regarding the adoption of VATS lobectomy. The investigators believe that by     decreasing the manipulation and dissection required by the surgeon on the PA branches, these     procedures will be safe and therefore more prevalent for anatomical pulmonary resections.   "
63397|NCT02455830|"     This is a observational study to assess the effects of and to explore the mechanisms of     autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring     serum cytokines.   "
63361|NCT02456298|"     The main purpose of this study is to determine the most efficient way for families to reduce     problem behavior in their children with an autism spectrum disorder. Parents will be trained     using telehealth to use applied behavior analysis (ABA) procedures to improve child behavior     and communication. The study compares an established type of ABA assessment and treatment to     a briefer, more streamlined version of this same type of assessment/treatment.   "
63362|NCT02456285|"     Background When first diagnosed, colorectal cancer has already metastasized in about 20% of     patients to the liver or further (termed synchronous disease). For patients with metastatic     disease limited to the liver, major surgery to resect both the primary colorectal cancer and     the liver metastasis provides 5-year survival rates of 25-40%.      Conventional surgery removes the colorectal primary first, followed by adjuvant chemotherapy,     and then resection of the liver metastasis. Surgical advances make synchronous resection     (removing both primary and liver metastasis together) and liver-first resection possible.      Currently, there is no conclusive evidence to show which approach improves morbidity or     survival, and therefore there is no optimum clinical pathway. Treatment is decided at     multidisciplinary team (MDT) meetings and is dependent on multiple factors: cancer staging,     patient health and preferences, and clinical experience.      Methods Colorectal cancer with Synchronous liver-limited hepatic Metastasis: an Inception     Cohort (CoSMIC), will consent and recruit patients with a new diagnosis of synchronous     colorectal cancer limited to the liver.      Patients will be recruited at Manchester Royal Infirmary (a National Health Service (NHS)     regional cancer-network approved Hepato-pancreato-biliary specialist centers over 2 years     using standardized data collection. The sequence of treatment received by each patient, and     factors influencing treatment decisions, will be recorded and evaluated against European     Society of Medical Oncology guidelines. The effect of surgery on patient quality of life,     morbidity, mortality and the long-term outcome will be measured and compared for different     treatment sequences adjusted for prognostic factors.      Anticipated Outputs and Value of Findings Direct comparison of conventional and new surgical     sequences will be explored. Patient engagement, use of standardised recording, identifying     common clinical patterns and decision making, and understanding sources of variation are     essential steps to develop a definite randomized control trial to resolve the optimal     clinical pathway.   "
63363|NCT02456272|"     This is a French pilot study in the Toulouse University Hospital that will include a minimum     of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a     hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.   "
63365|NCT02456246|"     Stereotactic body radiotherapy (SBRT) has emerged as one of the leading curative method for     early stage non-small cell lung cancer (NSCLC). However, assessing the status of the disease     during post-SBRT follow up presents a challenge. Currently, chest Computed Tomography (CT) is     the main technique to detect whether cancer has come back, but this method has demonstrated     poor accuracy and reliability in determining if the observed post-operative lung changes are     benign or malignant.      Positron-emission tomography (PET) is an imaging technique that uses special radioactive     tracers to cell growth. The use of PET scans with a tracer that target the pathways of DNA     synthesis may be more accurate than CT for detecting if the cancer has come or not.      The purpose of this study is to see if a PET radiotracer called 18F-FLT     (3'-deoxy-3'-fluorothymidine) can identify cancer recurrences accurately compared to regular     CT scans.   "
63367|NCT02456220|"     The aim of the study is to perform a three-dimensional (3D) evaluation of the dentoskeletal     changes in pubertal Class II malocclusion subjects treated with the Herbst appliance (HAG),     in comparison with a Class II comparison group (CG). 3D virtual models generated from three     time-point CBCTs (T0, baseline; T1, immediately after Herbst insertion; and T2, 8 months     after) of 25 HAG patients will be evaluated. Virtual models obtained from 25 Class II     malocclusion patients, in the same stage of biologic maturation and skeletal abnormality, but     with no orthopedic treatment will be constructed for the CG subjects. These CG patients are     under orthodontic treatment, but only with teeth alignment. Voxel based registration on the     anterior cranial fossa will be used to assess maxillary and mandibular displacement/articular     fossa remodeling; regional registration on the mandibular corpus will be performed to     evaluate mandibular growth and mandibular dental changes; and regional registration on the     anterior region of the maxilla will be performed to evaluate maxillary growth and maxillary     dental changes.   "
63368|NCT02456207|"     The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400     versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma.      The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of     SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric     antibodies (HACA).   "
63369|NCT02456194|"     This is a prospective clinical trial of tibial plateau fractures treated with internal     fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into     various bead sizes for implantation into bone defects. The graft material chosen for this     study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void     filler and may be mixed with a variety of antibiotics. The combination of STIMULAN +     antibiotic in bead form is the study device.      Our primary study aim is to look at resorption and remodeling of the study device into bone.     Another important aim of the study is to look at subsidence, or collapse, of the joint     surface.   "
63370|NCT02456181|"     The overall aim of the proposed project is to test the efficacy of a relatively new,     well-developed math program on the math achievement of elementary school students in     mainstream classes in urban schools. Use of this program is increasing in Canada and the     United Kingdom. Preliminary findings derived from uncontrolled trials and our own pilot,     randomized controlled trial suggest it may yield meaningful gains in math achievement for     both at-risk and achieving students, as indexed by their performance on national exams, in     national math competitions, as well as on standardized measures of math achievement. However,     the program has yet to be rigorously evaluated to determine its relative efficacy compared to     the math programs typically used by school boards. The program provision of grade-specific     teacher's guides and student workbooks (for grades 1 to 8), and minimal teacher training,     points to its potential utility for full-scale implementation, should its efficacy be     confirmed.   "
63398|NCT02455817|"     Single center, retrospective registry to collect data regarding the rate of angina (any and     CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel     revascularization rate within 12 months post stent implantation.   "
63399|NCT02455804|"     This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical     study that will be conducted at up to 15 sites in the United States (US). All subjects will     be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3     years post-index stenting procedure. An unscheduled follow up may be conducted as clinically     warranted.   "
63400|NCT02455791|"     The goal of this clinical research study is to compare the use of an ultrasound-guided biopsy     with what is found during surgery in finding evidence of the disease.   "
63371|NCT02456168|"     Cognitive impairment occurs in as many as 80% of lupus patients and affective disorders,     depression and anxiety, are also common. Both of these problems contribute significantly to     disease burden and disability. Associations between serum anti-NMDAR Aab and cognitive and     behavioral changes in human SLE have remained controversial, however, elevated titers of     these Aabs in cerebrospinal fluid (CSF) correlate with severe central nervous system     manifestations, such as coma and psychosis. The aim is to study the progression of disease     (cognitive and behavioral impairment) over a 2 year period in SLE subjects with     neuropsychologic and behavioral testing and correlates of disease progression using resting     FDG-PET and serum Anti-NMDAR Aab. The correlations between hippocampal hypermetabolism,     Anti-NMDAR Aab and memory impairment observed in the cross-sectional studies will be     validated by baseline measurements in the proposed studies.   "
63372|NCT02456155|"     The investigators assessed the utility of ultrasonography in confirming the position of nasal     jejunal tube after bedside placement when compared with endoscopic placement in patients with     severe acute pancreatitis.      Primary endpoint:      Success rate.      Secondary Endpoint:      Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after     placement), Tolerance of enteral nutrition, Time to approach the target calories.   "
63373|NCT02456142|"     Pain is a subjective sensation which in children can only be experienced and most times not     expressed. Pain management in children thus falls short of their adult counterparts. Acute     pain of surgery causes significant suffering and stress. In children, pain management has     lagged behind because of the belief that children's pain receptors are less well developed     than their adult counterparts. However this has been proven to be false as development of     pain receptors has been shown by 26th week of gestation. Caudal analgesia with plain     bupivacaine has been used for effective post operative analgesia. Resources sometimes limit     acquisition of additives to bupivacaine to be delivered into the intrathecal space.      The fear of pharmacological adverse effects of opioids has restricted their use especially     among the anesthesia officers who deliver the bulk of anesthesia services in Uganda and this     has led to poor pain management in pediatric populations Mulago national referral hospital is     a resource limited centre with regards to human resource, equipment and drugs. This is mainly     due to lack of sufficient funds and large volume of patients with the nursing staff being     overwhelmed by the patient capacity. Drug administration is often not done on time and     continuous assessment of pain scores in children is not adequate resulting in poor post     operative pain management. Pain control thus will depend on analgesia provided at the time of     operation creating a need for prolonged pain control measures.      Studies done have compared intravenous morphine administration versus caudal analgesia and     are mostly focused of sub umbilical surgery however none has been done in our setting.     Bupivacaine and morphine are now more readily available and can be used for post operative     analgesia. However studies on the timing to the next analgesic requirement have not been     compared/done in Mulago national referral hospital.   "
63374|NCT02456129|"     This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI)     between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using     intravenous microtracer dose of [14C]vilaprisan.   "
63375|NCT02456116|"     The purpose of this study is to evaluate the use of needle acupuncture in comparison to a     conventional postoperative pain management in terms of reducing pain and pain medication use     in an interdisciplinary setting in a controlled, randomized study design after implantation     of total knee arthroplasty .   "
63376|NCT02456103|"     This is an open-label extension study for patients who complete a Phase 3, placebo-controlled     study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving     chronic inhaled aminoglycosides.   "
63377|NCT02456090|"     The purpose of the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles,     Body Weight and Health Care is to use clinical data from electronic health records (EHR) and     patient reported outcomes (PRO) to answer questions of clinical importance to patients,     providers, and other stakeholders.   "
63379|NCT02456064|"     The purpose of this study is to determine whether a non-drug intensive program can help     improve control of type 2 diabetes mellitus.   "
63380|NCT02456051|"     Pancreatic Cancer is a leading cause of cancer-related death. To date, only one fifth of     patients at diagnosis is presented resectable because the diagnosis is often delayed making     the 5-year survival of this disease globally less than 5%. An early diagnosis in these     patients is currently not possible given the economic disadvantages of a population-wide     screening. New evidences identify patients with new-onset diabetes as a subgroup of patients     at high risk of developing this disease (RR 5:38). In a subset of these patients a mediator     secreted by the tumor, the Adrenomedullin, could be responsible for the onset of diabetes.     Our goal is therefore to assess the different impact of Pancreatic Cancer depending on     Adrenomedullin values in patients with newly diagnosed diabetes mellitus.   "
63381|NCT02456038|"     The aim of this study is to assess safety and efficacy of Asfotase Alfa (ALXN1215) in     patients with hypophosphatasia   "
63382|NCT02456025|"     The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01%     eyedrops in patients with vernal keratoconjunctivitis.   "
63383|NCT02456012|"     The purpose of this study is to determine whether a long-term prophylactic use of     esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the     recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy     in high-risk patients whose Rockall score ≥ 6.   "
63384|NCT02455999|"     The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001     eye drops versus placebo in patients with ocular pain associated with Dry Eye Syndrome.     General and local tolerability are also evaluated.   "
63385|NCT02455986|"     A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote     physical activity (PA).   "
63401|NCT02455778|"     This double blind placebo control study with supplementation of oral Cinnamon is being     conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may     lead to improvement in body composition and metabolic parameters.   "
63402|NCT02455765|"     The study will investigate if consumption of amino acid mixtures results a change in glycemic     response of carbohydrate (white rice) and insulinemic response at different doses and timing     (before consumption of carbohydrate).   "
63403|NCT02455752|"     The study involves the use of Retroperitoneal plane for TME for rectal anterior resection.     Through a pilot prospective study, LR-TME will be assessed as one arm study.   "
63404|NCT02455739|"     The investigators aimed to assess whether postoperative gum chewing improve intestinal     functions.   "
65032|NCT02434458|"     The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small     fiber nerve function, specifically those of the sudomotor, in patients with autoimmune     disorders (i.e fibromyalgia and rheumatoid arthritis).   "
63386|NCT02455973|"     This study is a randomized clinical trial with two interventions: control group and     intervention interdisciplinary group, without cross-over.      Control Group (CG): In this type of intervention, the focus will be the development of skills     through educational activities on health using the pedagogy of transmission.      Interdisciplinary Intervention Group (IG): In this type of intervention, the focus will be     the development of skills through educational activities on health that provide the     development of autonomy and empowerment for behavior change, based on interdisciplinary     motivational strategies. All topics will be focused on the major cardiovascular risk factors     considered modifiable.      The staff is trained to the techniques of motivational interviewing and transtheoretical     model of change and the health issues related to the modification of lifestyle.      So this interdisciplinary intervention with adolescents seeks to measure the result of an     educational proposal using the techniques of motivational interviewing and transtheoretical     model of change, for all professionals involved independent training in health issues related     approach to lifestyle modification and the inclusion of family in this process.   "
63387|NCT02455960|"     This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in     chronic kidney disease (CKD) patients.   "
63388|NCT02455947|"     The purpose of this study is to investigate the effect of Inquiry based stress reduction     (IBSR) meditation technique on levels of burnout and wellbeing among teachers.   "
63389|NCT02455934|"     Randomized, double-blind, crossover-trial, 30 subjects in each groups, either males or     females, normal fasting glucose or pre-diabetes, aged > 18 years old to perform oral sucrose     tolerance with either one of the 5 study products        1. Sucrose 50 g        2. Sucrose 50 g + D-allulose (psicose) 2.5 g        3. Sucrose 50 g + D-allulose (psicose) 5 g        4. Sucrose 50 g + D-allulose (psicose) 7.5 g        5. Sucrose 50 g + D-allulose (psicose) 10 g      Primary endpoints:        1. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage          on glucose tolerance        2. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage          on insulin levels   "
63390|NCT02455921|"     The aim of this prospective randomized study is to investigate comparatively the effect of     neostigmine-atropine versus sugammadex on speed and quality of recovery and on postoperative     cognitive function & behavior in children undergoing ENT surgery under general anaesthesia.   "
63391|NCT02455908|"     The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical     and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in     5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin     inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic     nephropathy:      cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5     consecutive days, starting from 3 weeks after the first cycle.      cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first     cycle.      Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first     cycle.      Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during     the first cycle and progressively reduced during the subsequent cycles.      The first cycle will be performed during hospitalization in the investigators Unit;     subsequent cycles will be performed at nephrology outpatients. All laboratory values normally     utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be     evaluated during the first week of treatment and at the end of the protocol, together with     specific cellular values (Tregs, B cells, NK).   "
63392|NCT02455895|"     This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its     Vehicle, on the ocular skin flora.      In the pre-randomization phase, subjects will receive a single application of open-label     NovaBay iLid Cleanser.      In the randomization phase of Stages 1 and 2, subjects will self-treat with masked     Investigational Product twice daily for ten (10) days.   "
63457|NCT02455024|"     This is an observational registry to further characterize the safety profile of patients with     chronic myeloid leukemia in the chronic phase (CP-CML) treated with Iclusig (ponatinib) in     routine clinical practice in the US. The registry is focused on analysis of vascular     occlusive events.   "
63393|NCT02455882|"     Through the investigators' Breast Care Center at the University of Michigan Comprehensive     Cancer Center, the investigators treat approximately 75 patients per year with neoadjuvant     chemotherapy. The majority of the remainder of patients with stage II and III disease undergo     treatment with adjuvant chemotherapy either on a clinical protocol or as standard of care.     There is a subset of women with ER positive disease who do not receive chemotherapy because     of favorable tumor characteristics.      This tissue procurement protocol is designed to systematically collect tissue, urine and     blood specimens on patients undergoing neoadjuvant systemic therapy or adjuvant chemotherapy,     serially following treatment, and/or at the time of disease recurrence in order to     investigate mechanisms underlying development of metastatic disease, to identify predictors     of response and resistance to therapy, and to test potential new therapies for breast cancer     using a combination of patient-derived xenograft creation and new microfluidic technologies.   "
63394|NCT02455869|"     The present study is designed as a single-centre, randomized, controlled clinical trial to     evaluate and compare the clinical efficacy of two local drug delivery systems containing 1%     ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic     periodontitis as an adjunct to SRP.   "
63395|NCT02455856|"     The purpose of this study is to assess the effects of repeated once daily administration of     200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ     42847922 in healthy, male participants.   "
63396|NCT02455843|"     This study is a multicenter, randomized, open-label Phase III trial that compares microwave     plus chemotherapy versus chemotherapy in patients with advanced non-small cell lung cancer.     The primary endpoint is progression free survival (PFS) and the key secondary endpoint is     overall survival (OS). A total of 400 eligible patients will be randomized to receive either     microwave ablation combinated with first-line platinum-based doublet chemotherapy or     first-line platinum-based doublet chemotherapy in a 1:1 ratio until patients. The response of     microwave ablation will be assessed by the expert consensus for thermal ablation of primary     and metastatic lung tumors. Tumor response and progression will be assessed according to     Response Evaluation Criteria in Solid Tumors（RECIST）1.1.   "
63405|NCT02455726|"     Magnesium exerts analgesic effects in several animal pain models and in patients affected by     acute postoperative pain and chronic pain of neuropathic origin. There is no evidence that     magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD).      We describe the protocol of a single-center randomized double-blind clinical trial aimed at     assessing the efficacy of oral magnesium supplementation in controlling severe pain in     patients with advanced PAOD.   "
63406|NCT02455713|"     This study will examine the cardiopulmonary interactions that occur with increasing     ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left     heart syndrome before and after sternal closure. Outcome measures include oxygen delivery and     cardiac output.   "
63407|NCT02455700|"     Prospective randomised crossover trial to assess if there is a difference in the level of     pain experienced by orthodontic patients undergoing interpromixal enamel reduction at the     lower incisor region using either a motor driven reduction device or a hand held device   "
63408|NCT02455687|"     Many studies have worked on the efficacy and safety of Intravenous magnesium sulfate and     inhaled steroids beside the standard treatment for patients with severe asthma attacks.      Investigators hypothesize that, two doses if intravenous magnesium sulfate with or without     inhaled budesonide, would make the stay at the Pediatric emergency center (PEC) lesser,and     decrease the need of being admitted to Pediatric Intensive Care Unit (PICU) for children with     severe asthma attacks,compared to single dose of magnesium sulfate with or without inhaled     budesonide.   "
63409|NCT02455674|"     Weight calculation based on age could be performed according to APLS (Advanced Pediatric Life     Support) guideline recommendations in children requiring emergency treatment and intervention     in the field or during resuscitation with no active weight and height measurements. The aim     of the study is to investigate the suitability of weight calculation using mean ages on     clothing size labels (ACL) to the actual weight in real emergencies with no known actual age     of the patient (AA).   "
63436|NCT02455310|"     This study will perform a retrospective analysis to evaluate the effectiveness of a     multicomponent educational intervention to improve medication use and management of     behavioral and psychological symptoms of dementia, relative to a statewide intervention that     has been ongoing. Medication use and symptom severity outcomes will be compared among     intervention counties and demographically similar non-intervention counties.   "
63410|NCT02455661|"     FERARI is a single centre observational study comparing patients undergoing PCI either using     radial compression devices or femoral closure devices at the corresponding access site.      First primary outcomes consist of the occurrence of vascular complications at the arterial     access site including major bleedings as defined by common classification systems      Second primary outcomes consist of the occurrence of adverse cardiac events including     all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days     and 12 months of follow-up.   "
63411|NCT02455648|"     Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to     result in varying degrees of stenosis, especially if the resected area is large and/or     circumferential. A new technique was described where autologous cells from the patients own     oral mucosa are harvested and cultures on proprietary membranes (coated, temperature     sensitive). These membranes, coined cell sheets, are used to cover the mucosal defects.   "
63412|NCT02455635|"     Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic     with saline distension medium. The presence or absence of lower abdominal pain and the side     of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the     presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal     chromopertubation was done.   "
63413|NCT02455622|"     This long-term study will provide Elaprase treatment to children enrolled in this study and     will utilize data from both enrolled patients and Hunter Outcome Survey (HOS) patient     registry data to conduct the primary growth analysis to assess changes in height and weight     in patients with Mucopolysaccharidosis II (Hunter syndrome) MPS II.   "
63414|NCT02455609|"     Currently, opioids are widely used for pain relief, but they often provide sub-optimal     analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was     introduced as a spinal anesthetic more than twenty years ago and found to have advantages     over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in     postoperative pain without severe sedation. The objectives of this study were to compare the     efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their     combination when added to bupivacaine for postoperative analgesia in major abdominal cancer     surgery.   "
63415|NCT02455596|"     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor     and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors     who have failed standard treatment or are unable to receive standard treatment.   "
63416|NCT02455583|"     The purpose of this study is to examine the effectiveness of an HIV prevention intervention     called Project AIM (Adult Identity Mentoring) to delay onset of sexual activity and reduce     sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary     schools (Form 1 - 3) in Eastern Botswana.   "
63417|NCT02455570|"     Endoscopic ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of various     suspicious malignancies. The learning curve of EUS is regarded long but so far the literature     of this topic is minimal. Few studies have been published and there are no standardized or     validated methods to perform a systematic assessment of endosonographists in training. This     study is an observational study dealing with the matter of assessing endosonographists in     training.   "
63418|NCT02455557|"     This phase II trial studies the side effects and how well vaccine therapy works when given     together with temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines     made from the survivin peptide or antigen may help the body build an effective immune     response to kill tumor cells that express survivin. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet     known whether temozolomide is more effective with or without vaccine therapy in treating     glioblastoma.   "
90567|NCT02100631|"     Demonstrate that the vaccine offers protection based on antibody levels in older adults and     is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.   "
63420|NCT02455531|"     The purpose of this study is to compare direct and indirect measures of right ventricular     (RV) systolic and diastolic function between 11 year old subjects who had been randomly     assigned to receive a right ventricle to pulmonary artery shunt (RVPAS) vs. a modified     Blalock-Taussig shunt (MBTS) at the time of the Norwood operation.   "
63421|NCT02455518|"     The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of     the comparative efficacy of 4 oral analgesics in the initial management of acute     musculoskeletal extremity pain presenting to the ED.   "
63422|NCT02455505|"     The purpose of this study is to develop a screening tool to help identify family members who     may need professional emotional support. The investigators are interested in enrolling family     members of patients with advanced cancer care as well as family members who have lost a loved     one to cancer. Some screening tools to identify family members who might need support do     exist, but the investigators are hoping to develop one that is brief and easier for     healthcare providers to use. The information learned in this study will help us refine the     screening tool. The investigators are interviewing family members to identify which questions     or items work well, which seem unclear, and to understand how a family member might approach     completing the screening tool. Family member input will be essential in the development of     this screening tool.   "
63423|NCT02455492|"     This epidemiological study investigates the association of recent stroke, acute coronary     syndrome or pneumonia and adverse perioperative outcomes following elective non-cardiac and     cardiac surgery using routinely collected UK primary and secondary care patient data.   "
63424|NCT02455479|"     The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine     vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of a vaccine to     treat the neurological effects of cocaine by evoking immunity to prevent the effects of     cocaine on the brain.   "
63425|NCT02455466|"     The purpose of this study is to investigate if clinically non explainable high or low     Prostate-specific antigen (PSA) levels are associated with heterophilic antibodies in the     serum of participants. The investigators will examine if heterophilic antibodies are the     reasons of altered PSA levels.   "
63426|NCT02455453|"     The purpose of this study is to evaluate the uptake of a radioactive tracer     21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione (FFNP)     uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before     and after administration of estradiol for one day (estrogen challenge) to determine if the     change in uptake is a predictor of response to endocrine therapy (ET) in patients with     hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor     2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring     estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat     metastatic breast cancer. The investigators propose to study patients with biopsy-proven     newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to be     treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as     standard of care therapy.      Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one     immediately following the one day estradiol challenge before the start of standard of care     ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol orally     (three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour period.   "
63427|NCT02455440|"     Anesthesia techniques that minimize anesthetic requirements and their effects may be     beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in     blunting adrenergic response to several perioperative stimuli and so it might interfere in     the effect of the anesthetic drugs on the brain. This study was designed to investigate the     effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing     craniotomy.   "
63428|NCT02455427|"     Stroke is the second cause of death worldwide and represented the first cause of death in     Brazil between 2006 and 2010. Most patients survive, and there is a need to develop     cost-effective rehabilitation strategies to decrease the burden of disability from stroke.      This study addresses this important issue, by evaluating, in the early phase post-stroke,     effects of motor conventional physical therapy associated or not with transcranial direct     current stimulation (tDCS).   "
63429|NCT02455414|"     The goal of this study is to determine the pattern of early neurodegenerative changes in WFS     (Wolfram Syndrome). The investigator will perform cross-sectional and longitudinal     assessments of youth with WFS, targeting sensitive neural systems with quantified     neuroimaging and behavioral measures. In addition, the investigator will establish the     utility of a WFS severity rating scale (WFS Unified Rating Scale or WURS). Preliminary data     support the feasibility of this approach and its potential to generate important new     information about neurodevelopmental and neurodegenerative patterns in WFS. This work is     necessary to position the field for future clinical trials to test interventions for WFS     neurodegeneration. Ultimately, a better understanding of the trajectory of neurodegeneration     in WFS and the development of effective interventions may be relevant to other more common     neurodegenerative and endocrine (Type 1 and Type 2 diabetes) diseases in which ER stress has     been implicated.   "
63430|NCT02455401|"     The purpose of this study is to compare the effect of remifentanil on postoperative vomiting     in children undergoing strabismus surgery during sevoflurane anesthesia.   "
63431|NCT02455388|"     Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories     consumed by youth. The role of AS in health is contentious, and the reliance on self-reported     dietary data is an often-cited flaw in existing research. The investigators propose to     establish the validity of the d13C biomarker for AS intake from fingerstick blood samples in     children; our findings could significantly advance research addressing the health impacts of     AS intake in children and adolescents.   "
63432|NCT02455375|"     Routine Puumala virus (PUUV) infection diagnosis is performed using serological commercial     kits of which performances have not been established in real life, which use recombinant     protein from strains from Central or North Europe. Molecular diagnostic of these infection is     not the rule. Consequently the objectives of the project are to evaluate the performances of     the serological commercial assays in real life in France and to assess the use of urine     versus plasma for the molecular diagnostic of this infection.   "
63433|NCT02455362|"     Breathlessness, the sensation of breathing discomfort, is a major problem in people with     chronic obstructive pulmonary disease (COPD). Breathlessness that persists despite optimal     management of the underlying disease(s) is said to be refractory.      Preliminary evidence suggests that a small, regular dose of morphine helps to reduce safely     the sensation of breathlessness. However, this research on morphine for breathlessness has     not defined the best way to adjust the dose of the medication, or refined which people are     most likely to have benefit, no response or side effects.      This is a randomized, double-blind phase III trial in people with COPD and significant     refractory breathlessness, which will explore several important questions:        -  Are regular, low dose opioids (morphine) at four possible doses over 3 weeks more          effective than placebo medication (containing no active ingredient) at improving          breathlessness?        -  Does the medication have any effect on daily activity, breathlessness, and quality of          life?        -  What are the common side effects of this intervention?        -  Does the benefit from the drug outweigh the side effects it produces?        -  Are there specific characteristics of people who are more likely to receive benefit from          sustained release morphine?      Participants will be allocated to receive three weeks of morphine sulfate (and laxative,     docusate with senna), or placebo (and placebo laxative). The dose of morphine may be     increased each week for weeks two and three. All medicines will appear the same (blinded) and     neither the doctor nor the participant will know which medication the participant is     receiving.      Participants will have a medical interview, physical examination to collect some general     health information, and baseline measurements including; daily activity, symptoms, and     quality of life. A small amount of blood may be required to check eligibility. Further blood     samples may be taken at week 1 and 3 to enable testing on how individuals respond to opioids,     further consent will be obtained for these samples. Data on benefits, side effects, and     medical care will be collected during comprehensive weekly visits. Participants will also     fill out a simple diary twice daily for weeks one to three of the study, and for one day each     week during an optional 3 month extension stage.      The outcome of this study may enable better management of symptoms and activity in people     COPD with medicines that are shown to be effective and safe.   "
63434|NCT02455336|"     Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs     earlier in life, at a greater prevalence than that of the general population, and is the     primary cause of death after the first year of injury. During the chronic phase of SCI, a     characteristic dyslipidemia emerges, which is characterized by low serum high density     lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an     independent risk factor for coronary artery disease, and elevations in serum triglycerides     (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually     similar to those of the general population. The current proposal in persons with SCI aims to     determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid     medication whose primary action lowers serum TG and raises serum HDL-C levels.   "
63438|NCT02455284|"     White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and     to the brain stem and spinal cord. These tracts form the internal part of the brain and     transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for     numerous neurological diseases.      Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique     providing information on white matter tracts (tractography) by studying water diffusion.     Since it is based on complex mathematical models that only indirectly evaluates the     underlying anatomy, tractography need to be validated before being used for research and     clinical purposes. Several validation techniques were previously proposed, none of them being     fully convincing in human.   "
63439|NCT02455271|"     To investigate the safety and efficacy of administration of eszopiclone for 6 months in     insomnia participants.   "
63440|NCT02455258|"     The aim of this study is to empirically evaluate the impact of a Dance/Movement Therapy     program adapted to older adults. Participants over 60 years old are enrolled in one of three     groups: Dance/Movement Therapy, Aerobic Exercise or Waiting List (control group) for 12     weeks. The training groups occur 3 times a week for 1 hour each session. Physical condition,     cognitive function, general health and lifestyle, and stress hormones are assessed at     baseline, after 12 weeks and after 28 weeks.   "
63441|NCT02455245|"     This study is trying to learn and understand if the chemotherapy drug called carboplatin     works as well as the standard therapy. The standard therapy for Low Grade Glioma (LGG) in     children and young adults is using a combination of carboplatin and vincristine. Studies in     children have shown that the use of carboplatin alone has promise of being just as effective     for treating LGG as standard therapy. Additionally, this study will try to understand if     treatment with carboplatin alone is associated with an improved quality of life for LGG     patients and their families.   "
63442|NCT02455232|"     The aim of this study is to determinate what are the main muscles regularly involved in the     spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow     flexors. Three selective motor block nerves will be carry out in order to assess the gain of     the range of motion (passive and active) of the elbow after each Motor Block Nerve.   "
63443|NCT02455219|"     A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or     filter that enhances or improves photos. The prototype collimators are able to magnify target     organs about four times compared to the current collimators. In this study we are validating     a new collimator design, which will allow for quantitative measurement of dopamine receptors     within the brain, not previously performed using a single photon gamma camera.   "
63444|NCT02455206|"     The purpose of this study is to investigate if a physical activity counseling program during     pulmonary rehabilitation increases the physical activity level in daily life in patients with     Chronic Obstructive Pulmonary Disease.   "
63446|NCT02455180|"     The purpose of this study is to determine the pharmacokinetic properties of two different     dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit with     life-threatening illness.   "
63447|NCT02455167|"     1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1,          cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin          (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).        2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV)          treatment using a new test of liver function, HepQuant-SHUNT.   "
63448|NCT02455154|"     To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in     patients receiving adjuvant endocrine therapy.   "
63449|NCT02455141|"     To compare disease-free survival (DFS) rate of adjuvant chemotherapy     epirubicin-cyclophosphamide followed by weekly paclitaxel (EC-wP), or weekly     paclitaxel-carboplatin (EC-wPCb) in triple-negative breast cancer.   "
63489|NCT02454595|"     This is a prospective open registry to measure the impact on first-line therapy of genomic     testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage     localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue     will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score     will be shared with the physician and the patient.   "
63450|NCT02455128|"     This is a randomized clinical trial that aims to investigate the effect of therapeutic     listening anxiety and preoperative fear of patients hospitalized for surgical treatment of     colorectal cancer. Physiological variables will be evaluated (heart rate, blood pressure and     respiratory rate), cortisol and salivary amylase and anxiety scores by State-Trait Anxiety     Inventory and fear for Surgery Fear Questionnaire. The data of the variables will be compared     at two different times (before and after the intervention).   "
63451|NCT02455115|"     Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow,     glomerular filtration rate and renal oxygen demand in patients with terminal liver failure     directly after liver transplantation.   "
63452|NCT02455102|"     The aim of this randomized controlled study is to evaluate whether a newly designed     electronic warning system will increase the initiation rate of adequate stroke preventive     measures in patients with atrial fibrillation.   "
63453|NCT02455089|"     Given that GADD34 has been described as a potential key regulator of pro-inflammatory     cytokine production in human and elevated blood marker in SLE patients, this study aim to     prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker     to assess the risk of SLE flare.   "
63454|NCT02455076|"     The purpose of this study is to try and achieve similar glycemic control in general     non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in     combination with basal insulin as compared to treatment with basal bolus insulin alone. The     association between hyperglycemia and poor clinical outcomes in patients with diabetes is     well established. Previous studies have shown that basal bolus insulin regimens improve     glycemic control and reduce the rate of hospital complications compared to sliding scale     regular insulin (SSRI) therapy, but has a significant risk of hypoglycemia. The investigators     will compare the efficacy and safety of exenatide alone or in combination with basal insulin     to control high blood glucose levels resulting in a lower risk of hypoglycemia.   "
63458|NCT02455011|"     This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate     safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2     diabetic subjects. The study will be conducted at multiple sites in the United States and     will enroll approximately 102 subjects with Type 2 diabetes who are either treatment-naïve,     controlled with diet and exercise or treated with oral antidiabetic medications.   "
63459|NCT02454998|"     Alveolar bone grafting (ABG) is an essential part of the surgical management of cleft lip and     palate patients. This procedure could obliterate oronasal fistula, stabilize dental arch,     offer bone matrix for adjacent teeth eruption. Moreover, by obliterating oronasal fistula, we     stop the chronic irritation of nasal mucosa by oral content. Hence, the symptoms of     rhinorrhea or nasal obstruction could be improved. This dental arch defect could predispose     further dental arch medial collapse. Without alveolar bone grafting the dental arch is not     stable, dental movement during orthodontic treatment is limited and dental arch expansion is     not possible.      Previous to operation, the patient suffered from dental crowding and dental inclination     toward to the cleft. This produces a difficult dental hygiene and predispose to dental caries     and gingivitis. Pre-operative orthodontics treatment is advised in many centers. By aligned     the teeth previous to surgery, with a better dental hygiene, we purpose that the infection     rate will be reduced and success rate will be better.      The Purpose of this study is to determine whether pre-operative orthopedic treatment will     affect secondary alveolar bone grafting outcome and to assess the nasal change after alveolar     bone graft.   "
63460|NCT02454972|"     A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid     Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall     response rate (ORR), in the following advanced solid tumors: small cell lung cancer (SCLC),     head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma,     endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown     primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs)   "
63461|NCT02454959|"     This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days),     Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to     Severe COPD with and without a Valved Holding Chamber.   "
63462|NCT02454946|"     The researchers aimed to investigate the relationship between ABO blood types and erectile     dysfunction.   "
63463|NCT02454933|"     A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of     AZD9291 in Combination with MEDI4736 versus AZD9291 Monotherapy in patients with Locally     Advanced or Metastatic Epidermal Growth Factor Receptor T790M mutation-positive Non-Small     Cell Lung Cancer who have received Prior Epidermal Growth Factor Receptor Tyrosine Kinase     Inhibitor Therapy   "
63464|NCT02454920|"     Study designed to determine the ability and accuracy of anterior segment optical coherence     tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the     insertion site of the extraocular muscles (EOM) in adults with and without previous     strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT     limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion     measurement using calipers (gold standard).   "
63465|NCT02454907|"     Many patients with multiple sclerosis (MS) experience relapses of disease activity during     which they have increased numbness, weakness, visual problems, or other symptoms. If a person     with MS has new symptoms that are concerning to them, their doctor may want to see them in     the office in order to confirm that these symptoms are due to a true relapse of activity     before starting relapse treatment. This requirement can be frustrating for patients, who may     have to take time off from work or travel long distances for such unexpected doctors' visits.     In this study, the investigators will use input from patients with MS and MS physicians to     create a relapse questionnaire that can be used to confirm a relapse has occurred. The     investigators will also evaluate if having a more direct line of communication with the     provider's office improves overall patient care and satisfaction.   "
63511|NCT02454309|"     This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract     infections (UTIs) in women. Approximately 150 adult women will be recruited to participate in     this study. Subjects will be randomized to either the cranberry supplement or placebo     treatment for 12 months. Subjects and investigators will be blinded to which supplement they     are taking.   "
63466|NCT02454894|"     The study is carried out in a prospective randomized controlled way. In the context of     informed understanding from parents, compared with traditional process(no anesthesia; lying     without the pillow and fasting water and food for four hours after lumbar puncture), randomly     select lidocaine surface anesthesia and postoperative management (lying without the pillow     for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The     face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain     during and after lumbar puncture. Lumber puncture time, success rate and any postoperative     condition will be recorded and analyzed.A questionaire about the operation for all parents     and children will be investigated in order to establish an optimized lumbar puncture     management process.   "
63467|NCT02454881|"     To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in     intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for     posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.   "
63468|NCT02454868|"     Introduction: remifentanil's optimal dose for children intubation without neuromuscular     blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for     modeling remifentanil's dose-response curve for adequate intubation conditions as defined by     previous studies.   "
63469|NCT02454855|"     Melatonin may represent an effective complementary treatment to standard chemotherapy in     order to reduce asthenia, depression, sleep disturbances, cognitive impairment and     performance status as part of quality of life. Moreover, melatonin has been evaluated in     several clinical trials in cancer patients with no side effects . It could be particularly of     interest in elderly cancer patients as they exhibit a significant deficiency of melatonin     production .      The investigators propose to perform a prospective and randomized study to study the effect     of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer     patients (age ≥ 70) treated by chemotherapy.   "
63470|NCT02454842|"     This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib),     a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced non-small     cell lung cancer (NSCLC).   "
65194|NCT02432352|"     The purpose of this study is to assess the feasibility and acceptability of a family-based     preventive intervention designed to reduce sexual risk behaviors and depressive symptoms     among South African adolescents and their parents/guardians/caregivers.   "
63471|NCT02454829|"     Evaluation of ovarian function by a questionnaire and by medical file analysis of women and     girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997     an 2013 in the investigators' institution in order to evaluate their residual ovarian     function. A second part of the questionnaire concerns these women's satisfaction regarding     the procedure.   "
63472|NCT02454816|"     Global and regional initiatives have been launched for the dual elimination of     mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components     in the initiatives, early detection and timely intervention of pregnant women infected with     HIV and/or syphilis is critical. In order to improve the number of women tested and treated,     innovative strategies are needed.      Serologic tests are the diagnostic tests of choice for HIV and syphilis. There are two types     of serological tests (treponemal and non-treponemal tests) for diagnosis of syphilis. These     generally require venous blood for screening of symptomatic and asymptomatic patients. In     addition, these tests are technically demanding, and require laboratory equipment which is     not widely available in most resource-limited settings.      Recently, Rapid diagnostic tests (RDTs) that can be used at point-of-care for simultaneously     detecting antibodies to HIV and syphilis (dual HIV & syphilis treponemalRDTs) using     serum/plasma, venous whole blood, or finger-stick whole blood have been developed and are now     commercially available.      In low-resource settings, a combination of two or three rapid diagnostic tests (RDTs), in     which one screening test with a second test to confirm initial positive results or two RDTs     in parallel with a third test as a tiebreaker for discordant samples, can be used to diagnose     HIV on finger-stick blood. To date, there are few data on the implications of using these     RDTs in the antenatal clinic settings, although they have been evaluated in laboratory-based     studies and shown encouraging sensitivities and specificities as compared with reference     laboratory tests.      The objective of this research is to assess the uptake of syphilis testing after the     introduction of dual HIV/syphilis rapid testing as compared to single rapid syphilis testing     in antenatal clinics in Colombia.      The secondary objectives of the study are: To determine the uptake of treatment of syphilis     after the intervention, To determine the uptake of HIV testing in ANC attendees after the     intervention, To explore the acceptability of dual HIV/syphilis RDTs by ANC attendees and     health workers, To assess the organizational and socio-cultural advantages and barriers to     introduction with a aim of sustainable adoption of dual HIV/syphilis RDTs in antenatal     services, To determine the workload and cost implications of introduction of dual     HIV/syphilis RDTs in antenatal services   "
63473|NCT02454803|"     The primary purpose for this study is to understand the effect of botulinum toxin as a     treatment integrated in the management of spasticity (stiffness) in the arm and/or hand,     arising from any neurological condition. The study will look at the types of goals that     people choose for treatment, and the extent to which these are achieved in different     individuals.   "
63474|NCT02454790|"     Motive:      In order to improve the treatment technique, a comprehensive follow-up program is needed to     obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.      Goal:      To set-up and maintain a database containing treatment results in terms of tumor control,     side effects, complications and patient-reported quality of life.      A standard database of patients receiving photon treatment will be created. These data are     then linked to dose-volume data of radiotherapy, with the aim to build prediction models for     both tumor control and toxicity after radio (chemo) therapy that can later be used for     selecting patients for proton treatment.   "
63475|NCT02454777|"     This randomized pilot clinical trial studies the feasibility of high-intensity interval     training in improving cardiovascular fitness in patients with stage I-III breast cancer     undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may     cause side effects to the heart. Aerobic exercise may help the heart function better, which     may help protect it against side effects from trastuzumab. Exercise may also help reduce     fatigue and prevent cancer from coming back. High-intensity interval training involves short     bursts of higher intensity efforts with longer periods of recovery. This may also allow     patients who cannot exercise for a long period of time to still be physically active. This     trial studies whether patients can tolerate high-intensity interval training, and how well it     works in improving fitness in patients with breast cancer receiving trastuzumab.   "
63512|NCT02454296|"     To assess if paracervical block is effective at reducing discomfort during placement of     intracervical laminaria for pre-operative cervical preparation.   "
63513|NCT02454283|"     LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study     to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of     subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus     rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and     200 placebo subjects receive study drug.   "
63476|NCT02454764|"     After fulfillment of the selection criteria, all the patients included in the trial will be     administered Tenofovir that will be continued for 3 months and then stopped for 1 month,     LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir     and thereafter at 4 months patients with ALT >/= 1.5 times ULN will be randomised in 2 groups     to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone     which will be continued for 48 weeks and the patients with no rise in ALT will be excluded.     Patients will be closely monitored during the period of stopping tenofovir post pulse therapy     and liver function tests will be performed weekly. Patients will be closely observed for the     development of acute hepatitis or decompensation during the 4 - week period of drug     withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be     tested every 3 months. After stopping treatment followup will be done at 24 weeks post     stoppage of treatment to look for sustained seroconversion and virological/biochemical     response   "
63477|NCT02454751|"     Study Objective The primary object of this study is to investigate the safety and     effectiveness of fentanyl on the management of incident dyspnea.      Study Design The study design will be a cross over study with a minimum of a one hour wash     out period.   "
63478|NCT02454738|"     To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for     developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT     scan.   "
63479|NCT02454725|"     Early HIV diagnosis followed by linkage to treatment soon after HIV infection can reduce     mortality and prevent new HIV infections. To obtain the full benefit of early HIV diagnosis,     the US Centers for Disease Control and Prevention suggest that high risk groups get tested     for HIV regularly, every three to six months. This study will examine the feasibility of a     strategy to promote regular HIV testing and HIV risk reduction among Latino men at risk for     HIV which, if successful, will help to identify Latino men unaware of their HIV status,     benefitting them and the society.   "
63480|NCT02454712|"     PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable     to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and     pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.   "
63481|NCT02454699|"     This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study,     subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once     daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed.     Subjects must be 18 to 65 years of age, male or female; if female, be surgically-sterilized     or post-menopausal; if male, have undergone vasectomy; have a body mass index (BMI) of 18 to     32 kg/m^2; not be a user of nicotine-containing products; be willing to abstain from     nicotine-containing products, alcohol and illicit drugs during the study. Subjects will be     followed for 28 days post dosing.   "
63482|NCT02454686|"     Most of the postoperative complications that may occur after hepatectomy are related to the     underlying liver background, and the common preoperative tests do not completely predict such     complications. Transient elastography by Fibroscan is used to calculate the stiffness and the     steatosis of the liver, and it may be also used to predict postoperative complications after     hepatectomy   "
63483|NCT02454673|"     The purpose of this study is to evaluate whether the R0 rate, pathological response degree,     patterns of recurrence and long-term outcomes may be initially predicted in patients with     locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant     approach and salvage surgery.   "
63484|NCT02454660|"     Uncontrolled hypertension is a major cause of morbidity and mortality and many patients fail     to take their antihypertensive medication as prescribed. The investigators propose to use     artificial intelligence (AI) to allow short message service (SMS or text messages)     interventions to adapt to patients' adherence needs and substantially improve medication     taking. The aims of the study are to: (1) develop AI methods for adaptive decision-making in     human-centered environments and demonstrate the feasibility of the resulting AI-enhanced SMS     medication adherence intervention, (2) demonstrate that the intervention can learn by     adapting the SMS message stream according to patients' medication taking over time, and (3)     examine potential intervention impact as measured by improvements in medication adherence and     systolic blood pressures. The investigators will recruit 100 patients with uncontrolled     hypertension and antihypertensive medication non-adherence. Adherence and other covariates     will be measured via surveys at baseline, 3- and 6 months; blood pressures will be measured     at baseline and 6 months. Participants will be given an electronic pill-bottle adherence     monitor. Participants will receive SMS messages designed to motivate antihypertensive     medication adherence. Message content and frequency will adapt automatically using AI     algorithms designed to automatically optimize expected pill bottle opening. For Aim 1, the     first 25 patients will be enrolled to develop and test alternative RL algorithms and     fine-tune the system parameters. For Aim 2, the investigators will examine changes in the     probability distribution over message-types and compare that distribution with patients'     reasons for non-adherence reported at baseline. For Aim 3, the investigators will examine     changes in self-reported medication non-adherence and blood pressure and     automatically-reported pill bottle openings. This pilot study will establish the feasibility     and potential impact of this novel approach to mobile health messaging for self-management     support. The results will be used to support an R01 application for a larger and more     definitive trial of intervention impacts.   "
63485|NCT02454647|"     The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with     locally advanced gastric cancer and the identification of prognostic factors.   "
63486|NCT02454634|"     The NOA-16 trial is the first-in-man trial of the IDH1 (isocitrate dehydrogenase type 1)     peptide vaccine targeting the IDH1R132H mutation (amino acid exchange from arginine to     glutamine at position 132 of IDH1). The aim of this trial is to evaluate the safety and     tolerability of and immune response to the IDH1 peptide vaccine in patients with     IDH1R132H-mutated, WHO grade III-IV gliomas.   "
63487|NCT02454621|"     The study will recruit patients who smoke from a general practice clinic and randomize them     either to: (1) form implementation intentions by linking in memory situations in which they     are tempted to smoke with strategies to avoid smoking in those situations using a volitional     help sheet, or (2) to consider the situations in which they are tempted to smoke alongside     possible strategies to avoid smoking as presented in the volitional help sheet but not to     form implementation intentions. The effects on self-reported smoking will be assessed 1 month     post-intervention.   "
63488|NCT02454608|"     Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce     inflammation in a variety of tissues. Verapamil has also been shown to improve eosinophilic     inflammation in an animal model of asthma and also functions as a P-glycoprotein(P-gp)     inhibitor. A major subtype of chronic rhinosinusitis(CRS) is characterized by eosinophilic     inflammation as well as P-gp overexpression. The goal of this study is to therefore see     whether Verapamil may be used to treat CRS.   "
65654|NCT02426320|"     The purpose of this study is to estimate the hypothesized benefit of sedation interruption     protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate     recruitment rates, and adherence rates of such protocol.   "
63490|NCT02454582|"     SUMMARY AND AIM      Background:      The proper management of brain oxygenation is an essential component of all anaesthesiologic     procedures. Nevertheless, the brain remains one of the least monitored organs in the     perioperative phase and intensive care therapy.      The INVOS Brain Oxymeter (IBO) is a reliable trend monitor for changes in regional cerebral     oxygenation (rSO2).      It is a current assumption that rSO2 directly correlates with Sa02, which can be influenced     by different ventilation assistance systems, e.g. CPAP therapy.      Objectives:      The project aims at investigating changes of rSO2 in patients undergoing CPAP therapy for     max. 15 minutes, in order to evaluate the effect of CPAP on cerebral oxygenation.      Methods:      NIRS measurement (with IBO) will be performed on the temporoparietal cortex on both sides of     the head. The trial will consist of two parts i.e. with or without ventilatory assistance.     The order of starting the study with or without CPAP therapy will be randomized. During each     part the measurements will be performed until reaching a steady state (no change in rSO2 ± 2%     for 3 min) but with a maximum duration of 15min. After each interval a BGA (blood gas     analysis) will be performed.   "
63491|NCT02454569|"     The VFHCS is a long-term prospective cohort study of HIV infected patients from a     resource-poor rural setting in India. The aim of the study is to use data collected from     routine clinical care in order to describe the epidemiology of HIV and its related conditions     in the investigators area, and to study the effectiveness of health interventions in a     real-world setting (implementation and operational research).   "
63492|NCT02454556|"     This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental     study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the     original one (Gonal-f ®).   "
63493|NCT02454543|"     The aim of the study is to investigate, the effect of radical prostatectomy with extended     lymphadenectomy on cancer-specific survival, time to castration-resistance, time to     progression and quality of life in patients with a limited bone metastatic prostate cancer.     In addition the influence of patient- and disease-related factors on clinical outcome     (prognostic effect) and on the comparison therapy (predictive effect) will be examined.   "
63494|NCT02454530|"     The aim of this study is to describe in real-life conditions the determinants of use of GCSF     (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in     patients receiving chemotherapy for solid tumour according to the chemotherapy context:     adjuvant or metastatic setting.   "
63518|NCT02454218|"     tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study     deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of     40 patients, divided into two groups with sham interventions and active crossover.   "
63495|NCT02454517|"     This randomized phase III trial studies a diet and exercise program based on the Diabetes     Prevention Program to promote weight loss and improve health in men with low-risk or     low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that     promotes weight loss may influence prostate health. A combined diet and exercise program that     is based on the Diabetes Prevention Program may affect markers (or biomarkers) of prostate     cancer progression. Gathering this information may help doctors understand how obesity     affects prostate cancer progression and may help lead to a program that can reduce the risk     of prostate cancer progression.   "
63496|NCT02454504|"     With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted     using continuous intravenous infusion of curare, which ensures maximum neuromuscular     relaxation until the end of the intervention. Sugammadex, administered for the reversal of     deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a     positive effect also on the recovery of cognitive function, psychomotor coordination and     mental ability, effects undocumented in Literature.      The aim of the investigators study was to assess whether the reversal with sugammadex after     intraoperative continuous infusion of rocuronium, can improve the quality of awakening.   "
63497|NCT02454491|"     Transradial approach (TRA) for cardiac catheterization and percutaneous coronary     interventions (PCI) is increasingly being used worldwide. At the present is unknown the     cocktail of agents necessary to minimize local access site complications. The investigators     planned a prospective randomized clinical trial to test the superiority of verapamil vs.     heparin in the reduction of access site related complications.   "
63498|NCT02454478|"     Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with     Everolimus in participants with unresectable advanced or metastatic RCC.   "
63499|NCT02454465|"     With an increase of over 38% in neurological related hospital admissions between 2008-13,     there are now over 12.5 million cases of individuals with neurological conditions in the UK.     Following diagnosis of a neurological condition, there is often a period of adjustment to new     life circumstances, with changes to relationships, ability to work and leisure activities.     With a future often fraught with uncertainty, psychological difficulties such as Anxiety and     Depression are common. It is estimated that following diagnosis of a neurological condition,     up to 60% of individual's will experience mental health difficulties.      Acceptance and Commitment Therapy (ACT) has been gaining popularity in supporting those with     neurological conditions. ACT is based on emotional acceptance and supporting individuals to     live a valued life, despite ongoing symptoms. Research into the use of ACT with this     population has found it to be effective in reducing levels of psychological distress and     increasing psychological flexibility.      With limited resources and an ever increasing desire to improve interventions offered to     patients, services are now looking at new and innovative ways of offering increasingly     effective and satisfactory treatments. Therefore, in early 2014, the author devised a six     week ACT group intervention for adjustment following diagnosis of a neurological condition.     The intervention provides a combination of ACT techniques, in addition to a space for group     members to build relationships and share their difficulties, to help individuals increase     acceptance of their difficulties and reduce psychological distress.      Following an initial pilot, findings illustrated that participants' psychological distress     reduced and psychological flexibility increased. Therefore, this research project aims to     further evaluate the intervention under controlled conditions.   "
63500|NCT02454452|"     Randomized controlled clinical trial aimed to compare the effectiveness and safety of     radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous     insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of     saphenous vein reflux, patient quality of life and post-surgical complications.   "
63514|NCT02454270|"     The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities     (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose     (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to     participants with relapsed or refractory B-cell malignancies [diffuse-large B cell lymphoma     (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia     (CLL), and acute lymphoblastic leukemia (ALL)].   "
63501|NCT02454439|"     The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF     patients with NICD and reduced ejection fraction on 12-month HF status.      In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with     reduced ejection fraction patients with non specific intraventricular conduction delay (NICD)     has never been confirmed even if it is recommended.      At the moment, no dedicated study has already been performed to assess the benefit of CRT in     patients with NICD. Results from CRT therapy are contradictory in this patient group and have     only been obtained from subgroup analysis. Some of them don't show clinical benefit but     others show a benefit in term of an end-diastolic and/or end-systolic left ventricular volume     (decrease of the size and the volumes of left ventricule).      The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration     (≥120 ms) for the indication of CRT implantation, without any consideration for the type of     conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines,     consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in addition     to QRS duration (>150 ms). Indications for resynchronization have been restricted since     indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only in NYHA     III and ambulatory IV; level of evidence A). The same modifications have been applied between     2011 and 2013 in the European guidelines. None is known about patients with NICD and QRS >     130 ms.   "
63502|NCT02454426|"     This is a preliminary, open-label, clinical trial designed to assess the efficacy, safety,     and tolerability of vortioxetine for the treatment of major depressive disorder in patients     with coronary artery disease. In addition, the study will assess the effects of vortioxetine     on heart rate variability in these patients.   "
63503|NCT02454413|"     Clinical guidelines for denture care are available, but evidence for optimal nocturnal     storage is missing. The investigators (Duyck J., Vandamme K., Teughels W.) therefore     performed a study (submitted for publication) to evaluate the effect of different overnight     storage protocols on denture biofilm formation and maturation. The results of this study     showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline     Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage     reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no     mechanical denture cleaning was performed in the aforementioned study, the aim of the     proposed study is to evaluate the combined effect of mechanical cleaning and overnight     storage condition on the microbial composition and Candida albicans colonization of denture     biofilm formation. This information is required to develop a clinical guideline on acrylic     denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic     microorganisms, particularly in bedridden and immunocompromised patients.      It is hypothetised that mechanical denture cleaning will decrease the impact of overnight     denture storage condition on biofilm formation on acrylic removable dentures.   "
63504|NCT02454400|"     The aim is to study if pre-surgery physiotherapy improves function, pain and health in     patients with specific low back pain scheduled for surgery. Patients are followed over a two     year period. A secondary aim is to study what factors predict short and long term outcomes.   "
63505|NCT02454387|"     A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of     ONO-4474 in healthy volunteers.   "
63506|NCT02454374|"     This study is a randomised controlled clinical trial designed to evaluate the effectiveness     of two different exercise based treatments in the management of patients with knee problems     related to degenerative (wear and tear) changes.      Recent evidence suggests that putting weight through a joint (joint loading) may be     beneficial.      The Investigators know that physiotherapy and exercise is important in treating these     patients, but the investigators do not know which exercises work best. In this study the     investigators will be comparing current physiotherapy care against a new programme of     exercises that gradually increases the amount of joint loading.      The study will recruit approximately 140 patients from the Leeds Musculoskeletal (MSK)     service, who are over the age of 45 and have been referred for physiotherapy by their GP for     activity related knee pain.Patients who are suitable and happy to take part will be selected     randomly (not chosen by the patient or physiotherapist) to receive either normal     physiotherapy treatment, or the knee loading exercises. The treatment phase will last for six     weeks and participants will be asked to carry out their exercises twice daily during this     time. At the end of this period, patients will be asked tocomplete questionnaires and again     at six months so that the investigators can assess how the patients are doing.      The main aim is to evaluate clinical effectiveness of the progressive joint loading protocol.     However, the data collected will also be used to see if there is a way of identifying in     advance those who might respond better to either treatment.      The investigators will also collect some information relating to the cost effectiveness of     delivering different treatments. The final aim of this study is to test how easy it is to     collect more detailed data in this area if a related study were to be carried out in the     future.   "
63507|NCT02454361|"     This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the     safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single     ascending dose administration and with an open label food effect panel.   "
63508|NCT02454348|"     Sepsis, a systemic host response to the invasion of a pathogenic microorganism, may progress     to severe sepsis, wherein the patient experiences acute dysfunction in at least one organ     system, and further develop into septic shock if the patient cannot regain adequate systemic     blood pressure and perfusion after adequate and appropriate fluid resuscitation. Further     prospective study of the potential mortality benefit with combination norepinephrine and     vasopressin in critically ill patients with septic shock needs to be performed. Our research     will resolve this essential question and improve the scientific knowledge surrounding     vasoactive medications in patients with septic shock.   "
63509|NCT02454335|"     Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal     achalasia, performed by GI endoscopist without cutting any surface of the human body. The     main constituent of the procedure is the myotomy part, through which the endoscopist cuts the     muscle fibers in the submucosa. Since this procedure is completely new to the area of     treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in     relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia     presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be     followed up for symptoms and complications; data will be extracted and the appropriate     analysis will be employed to determine if there is any difference of outcome between the two     techniques of myotomy.   "
63510|NCT02454322|"     Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of     pregnancy. The primary aim of this study is to determine if women who receive magnesium are     less likely to experience postpartum depression. Other aims include examining the     relationship between receiving magnesium and cognitive function and birth experience.   "
63515|NCT02454257|"     The aim of the proposed study is to better understand the epidemiology of, risk factors for     and consequences of critical illness leading to improvements in the risk models used to     underpin national clinical audits for adult general critical care, cardiothoracic critical     care and in-hospital cardiac arrest using data linkage with other routinely collected data     sources.   "
63516|NCT02454244|"     Amygdala Retraining Treatment (ART) is a new and promising therapy for patients with Chronic     Fatigue Syndrome (CFS) and Fibromyalgia (FM), however, randomized controlled trials (RCT) are     scarce. The investigators have added mindfulness to this therapy, based on preliminary     reports of its efficacy on patients, obtaining Amygdala Retraining Treatment with Mindfulness     (ART+MF).      Other therapy that has been assessed in many psychiatric and medical disorders during the     last years has been Compassion Therapy (CT). There are no studies on its efficacy in FM.      Aims: The aim of this trial is to assess the efficacy of both ART+MF and CT on the general     function of the patients with FM. A secondary objective is to assess the effect of these     therapies on psychological (pain, depression, anxiety, etc.) and biological variables (some     biomarkers related with inflammation).      Methods:        -  Design: Randomized, controlled trial with three arms: a) ART+MF, b) CT and c) Relaxation          as control intervention.        -  Sample: A sample (N=60 patients, about N=20 for each arm) will be recruited from primary          care settings at the city of Zaragoza, Spain.   "
63517|NCT02454231|"     The investigators designed a randomized clinical trial (stem cell emergency life threatening     arteriopathy or SCELTA) to compare the therapeutic efficacy of the auto-transplant of     enriched circulating EPCs (ECEPCs) with auto-transplant of BM-MNCs. ECEPCs, obtained by     immunoselection of CD14+ and CD34+ cells, or BM-MNCs, were injected intramuscularly in the     affected limb of patients with critical limb ischemia (CLI).   "
63519|NCT02454205|"     This study aims to evaluate the impact of a new injection-free six-to-nine month treatment     regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose     isoniazid (INH) compared to the conventional empiric injection-based regimen of 21-24 months     treatment. The secondary aim is to determine if other treatment-related outcomes including     adverse events, adherence to treatment, culture conversion, and cure/completion are     significantly different in the intervention and conventional arms.   "
63520|NCT02454192|"     The purpose of this study is to systematically investigate across health center study sites     participating in this study the process of adopting, integrating, implementing, and diffusing     a minimum set of evidence-based interventions for the management of childhood asthma.     Investigators hypothesized that an intervention that is evidence- and consensus-based (i.e.,     minimum elements to be integrated into existing practice, dosing of each element) would be     implemented effectively, as measured by health center performance improvement on child health     outcomes, health care utilization, and other measures (e.g., avoidable costs).   "
63521|NCT02454179|"     Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with     advanced head and neck squamous cell carcinoma.   "
63522|NCT02454166|"     Background and objective: Stroke, which means sudden onset of cerebral vascular accident. The     earliest document was found in Neijing. The ancient physicians had different opinions and     points of view on the etiology and pathogenesis of stroke. Before the Tang and Song dynasty,     the exopathic wind theory was talked about. And, after then, the endogenous wind theory     was put forward. While in the Ming dynasty, Zhang Jing-Yue advocated that Stroke is not     caused by wind etiology'', highlighting the much difference of the thinking. Until nowadays,     many famous physicians have their own unique way to determine the etiologic factor based on     differentiation. To be practical, objectivity differentiating and determining the etiologic     factor of stroke is the foundation of establishing the treatment guidelines. The     investigators aim to establish the scientific epidemiological standard of traditional Chinese     Medicine (TCM) syndromes of acute ischemic stroke in Taiwan.   "
63523|NCT02454153|"     This is a randomized control trial in people with diabetes and obstructive sleep apnea who     will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep     education or healthy lifestyle and sleep education.   "
63524|NCT02454140|"     This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic     radiotherapy (SBRT) in pancreatic cancer.   "
63525|NCT02454127|"     A single-center randomized trial at an academic medical center in Boston, Mass, of overweight     or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants     were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January     24, 2002.   "
63526|NCT02454114|"     HOME FIRST (Home Followed - up with Infection Respiratory Support Team) is an early supported     discharge scheme. It will enable patients with lower respiratory tract infection (LRTI) to be     provided with high quality safe, effective, efficient patient centred care, tailored to their     needs in their own home; aiming to improve the overall experience of the service user,     improve patient outcomes and reduce hospital length of stay whilst simultaneously reducing     admission rates, an area of major strategic importance to the NHS.   "
63527|NCT02454101|"     To compare the short term risks and benefits of cord milking 5 times toward the neonate with     delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.   "
63528|NCT02454088|"     This will be a single-center, investigator-initiated, double-blinded, randomized,     bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without     Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands.   "
63529|NCT02454075|"     This study will evaluate whether treatment with YF476 is safe and effective in reducing the     size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL     cells, in patients with Zollinger-Ellison syndrome.   "
63530|NCT02454062|"     A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety,     Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1     in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.   "
63531|NCT02454049|"     The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time     trial performance in Swiss paracycling athletes compared to the ingestion of a placebo     supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will     be investigated in spinal cord injured and non-injured athletes.   "
63532|NCT02454036|"     Baseline self-report outcome measures will be completed and additional assessments will occur     mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months     following completion of all sessions. Patients and therapists will complete the evaluation     measures in private (at home, in an office).      At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and     individual formats. The course of individual treatment varies and group treatment consists of     10 1.5-hour weekly sessions in the intensive phase, followed by 2 1.5-hour bi-weekly     maintenance sessions. Individual treatment is one-on-one. In group treatment, there are     typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to     learn adaptive coping strategies and how to apply them to daily stressors. Additional content     discusses use of seeking information, enhancing social support, enhancing body esteem and     intimacy, and maintaining positive changes.   "
63533|NCT02454023|"     Obstructive sleep apnea (OSA) is common after stroke/TIA and, left untreated, is associated     with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite     its high prevalence, OSA often remains underdiagnosed after stroke. The purpose of this study     is to evaluate portable sleep monitors (PSMs) as a broad screening tool for OSA after     stroke/TIA. The study investigators hypothesize that the screening with PSMs will lead to an     increase in the diagnosis of treatable OSA after stroke/TIA and an improvement in     sleep-related and functional outcomes.   "
63534|NCT02454010|"     The purpose of this study is to determine the safety and tolerability in subjects who receive     FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors.   "
63551|NCT02453789|"     The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry     powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.   "
63535|NCT02453997|"     This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their     impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients     (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12     hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months'     intervals and also when clinically significant events occurred. The MPA levels will be     correlated with clinical parameters and outcomes. Pharmacogenomics studies will also be     carried out and correlated with MPA exposure and clinical outcomes.   "
63536|NCT02453984|"     By performing a 89Zr-MPDL3280A-PET scan prior to treatment with MPDL3280A, the uptake of the     tracer in the primary and metastatic tumor lesions and normal organ distribution can be     evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient     selection in the future.   "
63537|NCT02453971|"     The purpose of this study is to evaluate the effects of the German eCHECKUP TO GO (eCHUG-D)     in students. Compared to the control group subjects who conducted eCHUG-D should have less     alcohol consumption and less alcohol associated problems after three and six months.   "
63538|NCT02453958|"     Evaluation of the utility of a multi-modal assessment tool in distinguishing between     individuals with and without a history of mild traumatic brain injury.   "
63539|NCT02453945|"     The primary purpose of this study is to examine whether a properly fitted support bra on     females improves their quality of life post-sternotomy. Specifically, does a support bra     reduce discomfort, pain and wound dehiscence.   "
63540|NCT02453932|"     This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to     moderate vascular dementia in a more reasonable design.   "
63541|NCT02453919|"     The REgister of cardiovascular COmplications among people living with HIV (RECOVIH) is a     single hospital registry of adults living with HIV, with one or more other cardiovascular     risk factor, who undergo cardiac examination at the Cardiac Center of the Saint Antoine     Hospital. RECOVIH is an observational and prospective, monocentric (institutional) registry,     with anonymized cardiac, biochemical and associated data collection.   "
63542|NCT02453906|"     The investigators will use EEG, structural MRI, and resting-state functional connectivity MRI     to assess neuronal responses in 28 healthy subjects to different somatosensory stimulations.   "
63543|NCT02453893|"     This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical     study. Chinese subjects with Ischemic Schizophrenia.   "
63544|NCT02453880|"     Symptoms of anxiety and depression are common in adolescents and young adults with chronic     illnesses and are associated with decreased adherence to medical regimens. However, many     young patients go untreated for anxiety and depression. The purpose of this study is to     evaluate an online cognitive behavioral therapy (CBT) program in young adults with chronic     illness. Prior research has shown online CBT to be effective in multiple other populations,     but to the investigators' knowledge, this is the first study to examine web-based CBT for     young adults with chronic illnesses.   "
63545|NCT02453867|"     Study purpose To establish efficacy and safety of a reduced immunosuppressive therapy with     tacrolimus once daily for senior (>65 years of age) renal transplant recipients   "
63546|NCT02453854|"     A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the     'Small Changes' programme.   "
63547|NCT02453841|"     This proposed study will assess the hemodynamic effects and measure the systemic absorption     of topically applied oxymetazoline in patients undergoing functional endoscopic sinus     surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline     as standard of care during the surgery.   "
63559|NCT02453685|"     This trial is conducted globally. The aim of this trial is to compare stepwise insulin     intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin     glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled     on oral anti-diabetic therapy.   "
63560|NCT02453672|"     Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of     Bevacizumab   "
63617|NCT02452918|"     This is a Phase 4, multicenter, open-label safety study of a single 1200 mg intravenous (IV)     infusion of oritavancin in adult subjects on chronic warfarin with acute bacterial skin and     skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive     pathogens.      An additional group of patients with ABSSSI, who are not on concomitant warfarin therapy,     will also be enrolled to obtain information regarding the potential for antibody production     following a single dose of oritavancin administration in patients.   "
63548|NCT02453828|"     Perioperative management decisions must often be made quickly and rely on practitioners     having relevant facts at hand. During transitions of patient care between anesthesia     providers, known as handovers, information may not be completely or faithfully     communicated, consequently impairing the provider's ability to intervene correctly in     response to subsequent events. Checklists have consistently proven to be effective at     enhancing communications during handovers, but whether anesthesia checklists improve patient     outcomes has yet to be proven. The investigators propose to randomize intraoperative     anesthesia provider handovers to standard practice (no specific format) or to a handover     checklist presented by a decision-support system in conjunction with the investigators     electronic record. Specifically, the investigators will test the hypothesis that     incorporating a largely pre-populated handover checklist into transitions of intraoperative     anesthesia care decreases a composite of mortality and serious cardiovascular, respiratory,     gastrointestinal, urinary, and infectious complications.   "
63549|NCT02453815|"     Even slight reduction in serious complications related to blood pressure management would     easily justify the cost and relatively rare complications consequent to arterial catheter     insertion. However, it seems unlikely that major outcomes will be improved by the presumably     slight difference in hemodynamic control resulting continuous blood pressure measurement     rather than measurements at 2-5-minute intervals. There is considerable variation in practice     and no clear consensus whether arterial lines should be placed or not, especially in ASA 2     patients undergoing major non-cardiac surgery or ASA-3 patients undergoing moderate to major     non-cardiac surgery. Clearly, if there is no benefit to outcome, arterial lines, which are     invasive and costly, should not be placed routinely. The investigators therefore propose to     test the primary hypothesis that use of arterial catheters decreases the risk of a collapsed     composite of in-hospital mortality, re-admissions, MINS, AKI, stroke, respiratory and wound     healing and gastro-intestinal complications after non-cardiac surgery.      Secondarily, the investigators propose to test the hypotheses that arterial catheter use: 1)     decreases the duration of hospitalization; 2) increases blood gas, electrolyte, and     coagulation testing; 3) increases induction-to-incision time; and, 4) increases cost-of-care     (supplies,, blood tests, and induction-to-incision time).   "
63550|NCT02453802|"     The purpose of the study, therefore, is to conduct a prospective randomized controlled trial     to investigate the blood-conservation effect of TXA in different TKA patients groups with     rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion     and a third group of placebo and observe whether there is difference in the occurrence of     venous thromboembolism in those patient groups by venographic study   "
63552|NCT02453776|"     Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with     inflammatory bowel disease (IBD). However, a large proportion of patients will eventually     lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment     with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order     to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the     outcome of IFX treatment.   "
63553|NCT02453763|"     The purpose of this research study is to measure current flow inside the head using magnetic     resonance imaging (MRI). The data from this study will be used to map the current flow caused     from the electrical stimulation inside the head. The methods develop will be used to map and     better control delivery of the current for electrical stimulation to modify a psychiatric     condition such as depression; or other conditions such as epilepsy, Parkinson's disease or     autism.   "
63554|NCT02453750|"     We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway     inflammation as a first step to characterize the reported bronchodilator responsiveness.     Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to     document the amount and type of inflammation present. Another ancillary non-invasive measure     of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective     of this study is to determine if CDH patients have any evidence of airway inflammation. The     hypothesis of this study is that children with CDH do not have evidence of airway     inflammation associated with bronchodilator responsiveness. Based on this information,     treatment for CDH patients will hopefully be more accurate and appropriate for their specific     needs.   "
63556|NCT02453724|"     The purpose of this study is to investigate if diagnostic ultrasound as it is routinely     performed in humans causes lung hemorrhage significant enough to appear on thoracic CT. The     investigators' hypothesis is that diagnostic lung ultrasound will not cause lung hemorrhage     in humans. Damage to the lung in animal models has been shown to be mechanical rather than     thermal in nature and evidence suggests that this injury is likely not from inertial     cavitation but from alveolar resonance. Models of the alveolar resonance theory predict that     hemorrhage should not happen in adult human lungs if the ultrasound frequency is higher than     1.69 MHz and mechanical index (MI) is less than 1.9 which is maintained with standard     scanning protocol for thoracic ultrasound. A previous human study showed no gross macroscopic     lung hemorrhage in patients undergoing transesophageal echocardiography with pressures of 2.4     MPa and MI 1.3 with exposure durations ranging 7-68 minutes.      The investigators propose to perform a routine lung ultrasound exam on patients who are     scheduled to undergo chest computed tomography evaluation for pulmonary embolus as part of     their routine care. The ultrasound will be performed immediately prior to CT imaging and     markers will be placed on the patients chest to ensure the correct lung tissue is being     evaluated. There will be two sham markers so the radiologist will be blinded to which tissue     had ultrasound applied and which did not. The CT scan will then be evaluated per routine and     also to see if there are signs of microscopic or macroscopic hemorrhage under the skin     markers.   "
63557|NCT02453711|"     This trial is conducted globally. The aim of this trial is to investigate safety and efficacy     of once-daily semaglutide in obese subjects without diabetes mellitus.   "
63558|NCT02453698|"     The aim of this study is to investigate the effects of Methylphenidate on neural activity     underlying inhibitory control and error monitoring in healthy adults. More specifically, the     investigators aim to establish the baseline modulatory effect of Mehtlylphenidate on     bottom-up and top-down aspects of these cognitive processes. This work will further our     understanding of Attention Deficit Hyperactivity Disorder, Methylphenidate, and executive     functioning.   "
63561|NCT02453659|"     The long-term goal of this program of research is to develop and disseminate an efficacious,     group-based distress tolerance treatment for weight concern (DT-W) that will significantly     increase smoking cessation rates among women. The objective of this project is to conduct a     preliminary randomized controlled trial (RCT) (N = 60) comparing DT-W to a Health Education     (HE) comparison intervention, in which both groups also receive standard behavioral smoking     cessation treatment (ST) including counseling and transdermal nicotine patch (TNP), and     examine potential mechanisms that may underlie the efficacy of DT-W in improving smoking     outcomes at 1-, 3-, and 6-month follow-ups.   "
63562|NCT02453646|"     A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the     NexSite HD Catheter for long term vascular access for hemodialysis.   "
63563|NCT02453633|"     The project will be done at the ear, nose and throat outpatient department at Lovisenberg     Diakonale Hospital (LDS) in 2015-2016. About 12% of patients with appointments at the     surgical outpatient clinic at LDS do not attend their appointment even after receiving both     letters and shot message service (SMS) reminders. Persuasion theory suggests that the SMS     reminders may be more effective if the text appeals more to the patient's feelings. The     project is designed as a randomized controlled trial in which the control group receives the     standard text that has neutral content and the intervention group receives a more     emotion-based SMS reminder. The aim is to determine whether the more emotional text reduces     the proportion of patients who do not show up for their scheduled appointment at the surgical     outpatient clinic.   "
65234|NCT02431832|"     An open-label, one-sequence, multiple administration study for exploration of microRNA and     metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean     people.   "
63564|NCT02453620|"     This phase I trial studies the side effects and best dose of entinostat and nivolumab when     given together with ipilimumab in treating patients with solid tumors that have spread to     other places in the body and usually cannot be cured or controlled with treatment     (metastatic) or that cannot be removed by surgery (unresectable) or human epidermal growth     factor receptor 2 (HER2)-negative breast cancer that has spread from where it started to     nearby tissue or lymph nodes or other parts of the body. Entinostat may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth (locally     advanced/metastatic). Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere     with the ability of tumor cells to grow and spread. Giving entinostat and nivolumab together     with ipilimumab may be a better treatment in patients with solid tumors.   "
63565|NCT02453607|"     In this research proposal, the investigators will focus on methods to optimize the     therapeutic response to anti-TNF antibodies, by determining a correlation of 6-mp metabolite     levels with IFX trough levels, anti-IFX antibody levels and clinical response. The study will     also evaluate (in vitro) the possible impact of vitamin D on the interaction of IFX with     dendritic cells in both healthy subjects and patients with Crohn's disease (proliferation,     maturation, cytokine profile, apoptosis, gene expression).   "
63566|NCT02453594|"     This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory     classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed     after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or     failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a     Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive     auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed     to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT.      The primary study hypothesis is that treatment with single agent pembrolizumab will result in     a clinically meaningful overall response rate.   "
63567|NCT02453581|"     A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge     inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the     experimental anti-malarial product, OZ439.   "
63568|NCT02453555|"     This trial will compare the use of fiixed dose conbination of empagliflozin and linagliptin     to linagliptine alone in patient with type 2 diabetes mellitus   "
63569|NCT02453542|"     Background      The treatment of haemophilia A and B has been revolutionized by the use of factor     concentrate, both as prophylaxis and to treat bleeding episodes (on-demand treatment).     However, despite its advantages, repeated treatment with factor concentrate can lead to     development of inhibitors (antibodies) towards the coagulation factor in the concentrate.     Another patient group in which the bleeding symptoms are difficult to treat because of     inhibitors towards coagulation factors, most commonly FVIII, is patients with acquired     haemophilia. Patients with high antibody titers exhibit a deficient or no response to factor     concentrates and usually need treatment with bypassing agents, namely factor eight inhibitor     bypassing agent (FEIBA®, Baxter) och recombinant activated factor VII (rFVIIa, Novo-Seven®,     Novo Nordisk). The effect of the treatment cannot be accurately monitored by traditional     coagulation tests.      The aim of the study is to evaluate the utility of the global haemostatic methods in patients     with haemophilia with inhibitors. The objective is to improve the monitoring of the treatment     effect and thus increase the safety of the patient and the effectiveness of the treatment.      Patients and methods      Patients      The primary cohort will consist of fifteen patients with inherited haemophilia with     inhibitors as well as five adult patients with acquired haemophilia who are followed up at     the Coagulation Department of the Karolinska University Hospital, Stockholm, Sweden.      Blood samples will be collected from those patients at specific time points (see Design of     the study) during the course of two years (for each patient). The treatment (type, dose,     duration) will be determined by the treating physician.      Methods (selection)        -  Thrombin generation (Calibrated Automated Thrombogram, CAT® and a commercial kit from          Siemens®).        -  Overall haemostatic potential (OHP)      Design of the study      Timeframe for blood sampling: i) baseline (inclusion in the study), and ii) prior and after     administration of bypassing agents to either treat bleeding symptoms or before an invasive     procedure or as prophylaxis.      Data analysis      The variations in coagulation markers measured as described above (Methods) will be     associated to the clinical symptoms (bleeding), the level of coagulation factors (if     measurable) and the titers of the inhibitors.   "
63591|NCT02453256|"     This study will assess the efficacy and safety of tocilizumab compared with placebo in     participants with SSc across approximately 120 planned global study sites. The study will     consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week     open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind     treatment with active tocilizumab or matching placebo. In the open-label period, eligible     participants from either arm may receive active tocilizumab.   "
63618|NCT02452905|"     Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral     infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the duration     and severity of respiratory symptoms caused by bronchiolitis. Half of the participants will     receive NTZ while the other half will receive a placebo.   "
63619|NCT02452892|"     The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of     Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who     are treatment resistant.   "
63570|NCT02453529|"     This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult     male and female subjects.      Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1.     Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15     minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873.     The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing.     Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15     minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each     subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the     outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK     4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for     determining plasma WCK 4873 concentrations at 48 hours after the third dose.      Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory     tests (including liver function tests), ECG, physical examination and vital sign monitoring.     Subjects will discontinue study drug administration in the event of AST/ALT elevation of     greater than 3 times the upper limit of normal.   "
63571|NCT02453516|"     Surgery for breast cancer is associated with significant pain. The serratus nerve block     targets the interfascial plane either below or above the serratus muscle, blocking thereby     the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized     controlled double-blinded study is to see whether the addition of a serratus nerve block to a     general anesthesia results in a better postoperative pain control in patients undergoing     surgery for breast cancer.   "
63572|NCT02453503|"     Introduction :Oral lichen planus (OLP) is one of the most common disorders of the oral cavity     which is basically a chronic and inflammated mucocutaneous .There is no cure for OLP     currently. The main focus of treatment is to reduce the duration and severity of the     symptoms. This study was designed to determine and compare the parameters of improvement in     patient symptoms and lesions caused by oral lichen planus by using triamcinolone acetonide     mucoadhesive film and licorice mucoadhesive film.      Methods and materials :The study was randomized by double-blind clinical trial . Patients     with symptomatic OLP who referred to the Oral Medicine School of Dentistryin Medical Sciences     in Isfahan University participated voluntarily. The patients were divided into two groups     that were including 30 samples in each group. The first group was treated with triamcinolone     mucoadhesive film and the second group were treated with licorice mucoadhesive film. Data     were analyzed by using the Mann-Whitney test and t-test in SPSS software.   "
69473|NCT02376439|"     This research studies the energy balance behaviors (usual eating, physical activity,     sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean     the other is overweight).   "
63574|NCT02453477|"     This is a phase I/II study evaluating safety and efficacy of autologous hematopoietic stem     cells genetically modified with GLOBE lentiviral vector encoding for the human beta-globin     gene for the treatment of patients affected by transfusion dependent beta-thalassemia   "
63575|NCT02453464|"     This is an open-label, multicenter, dose-escalation study designed to assess the safety,     tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab)     Injection in combination with FOLFIRI in patients with previously treated metastatic     colorectal cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once     the maximum tolerated dose (MTD) of Sevacizumab has been established, additional patients     will be enrolled in the cohort-expansion stage (Stage 2).   "
63576|NCT02453451|"     Patients received a MitraClip procedure because of a leakiness of their mitral valves. During     this procedure the atrioventricular valves were stuck together permanently via a clip which     leads to a reduction of leakiness. As a result of this procedure a small hole remains at the     cardiac septum which is called an atrial septal defect (ASD). In most cases the hole will     close after a few weeks or months, but in many other cases not. Until now there is no exact     data about the effect of this hole on the filling pressure in the heart or on the blood flow     behaviour. So the aim of this study is a precise analysis of the blood flow mechanics during     and after the MitraClip procedure to identify criteria to get more informations for a better     strategy and regulation of the MitraClip procedure.   "
63577|NCT02453438|"     The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating     in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is     to improve the nation's capacity to conduct comparative effectiveness research that reflects     questions of greatest importance to patients and other stakeholders. A robust data     infrastructure will be built that, in phase one, allows participants to contribute data,     including those from participant questionnaires, visualize their own health information in     intuitive and helpful ways, and share their aggregated de-identified health information     within and outside of the Network.   "
63578|NCT02453425|"     The purpose of this study is to evaluate renal effects of 3 different levels of mean arterial     pressure in early case of septic shock. In 8 patients diagnosed with early septic shock, we     will adjust mean arterial pressure (MAP) to three different levels, using norepinephrine. At     each level of MAP, central and renal hemodynamics and oxygenation states will be measured.     Analysis will be made to describe the pathophysiology at MAP 75 mmHg, and then to evaluate at     which MAP renal function and oxygenation is least affected negatively.   "
63602|NCT02453113|"     The purpose of this is that the researcher can use low power Near Infrared laser treatment     non-painful and non-damaging dose to changes the skin properties.The researcher can prove     that signaling and a significant increase in the number of skin cells in skin tissue exposed     to the laser can improve the human skin immune system to help improve human body response to     vaccines.   "
63603|NCT02453100|"     An intervention consisting of group and home based exercise will be used over 6 months to     assess whether this is helpful in managing urinary incontinence in elderly village women in     Bangladesh. This intervention, supplemented by education about managing incontinence, will be     used in half the villages in the trial. In the other half women will receive only the     education component.   "
63604|NCT02453087|"     This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and     pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or refractory     B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the safety and     tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be assessed.   "
63579|NCT02453412|"     Patients suffering from end-stage renal disease (ESRD) are dependent on renal replacement     therapy (dialysis). The majority of dialysis is facilitated by hemodialysis. For hemodialysis     a vascular access is necessary, preferable an arteriovenous fistula (AVF) in which a vein is     directly anastomosed to an artery. In order to use the AVF for hemodialysis three criteria     have to be met; the minimal flow over the AVF is 600 mL/min, the diameter is at least 6 mm,     and the AVF is located less than 6 mm under the skin. Unfortunately, approximately half of     the patients (50%) are confronted with an AVF that does not meet these criteria; the so     called non-maturation or primary failure. In case of non-maturation the AVF is not only     unusable for dialysis, but also requires reinterventions on short- and long-term. Firstly to     mature the AVF, and secondly, when the AVF is matured, to keep the vascular access. Using a     computational simulation postoperative flow can be predicted. Based on patient-specific     duplex measurements, the model can calculate the flow that can be expected following vascular     access surgery for all AVF configurations; fore- or upper arm. These calculations lead to an     advice which configuration is indicated; a flow that exceeds 600 mL/min, leading to     maturation. Potentially the aforementioned 50% of non-maturation can be reduced. The patient     then has an adequate vascular access and reinterventions are adverted, resulting in a     decrease of costs, hospital demand, and an increase of the patients' quality of life. When     the expected reduction of non-maturation is confirmed, the computational tool can be offered     to other hospitals.   "
63580|NCT02453399|"     This study will evaluate transcutaneous electro stimulation device developed by Siano for     adequacy, safety and efficacy for the treatment and/or prevention of migraine pain for     migraine sufferers.   "
63581|NCT02453386|"     Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,     parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).   "
63582|NCT02453373|"     The aim of this study is to assess the feasibility of using the Life Recovery Systems     ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke.     This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke     at two clinical centers. Subjects will receive hypothermia plus conventional therapy (such as     IV-tPA therapy if indicated). Endpoints will include feasibility of cooling, adverse events,     and neurological recovery in comparison with matched historical controls.   "
63583|NCT02453360|"     Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain.     This pain can oftentimes be severe enough to limit participation in physical therapy and     ultimately delay discharge resulting in increased cost. Several strategies have been     developed in an effort to decrease postoperative pain following TKA while maintaining lower     extremity strength and maximizing participation in physical therapy. Recently, adductor canal     blockade has gained popularity as it is reported to provide analgesia to the anterior knee     without resulting in significant quadriceps muscle weakness. However, few studies have     carefully evaluated the impact of volume of injection of local anesthetic into the adductor     canal on motor weakness or pain control. The ability to achieve similar pain control with     decreased volumes of local anesthetic would allow the surgery team to apply more local     anesthetic to posterior knee structures. Decreased volumes of local anesthetic may also be     associated with a decreased risk of local anesthetic toxicity. This study aims to carefully     evaluate this relationship using a physical therapy evaluation method that relies on both     motor strength and pain control. In addition, the investigators hope to carefully evaluate     motor strength using a novel method of strength measurement in an effort to further evaluate     the impact of volume of injection of local anesthetic into the adductor canal on motor     strength.   "
63584|NCT02453347|"     The primary aim of this proposed study is to gather preliminary data for CES use in treating     PTSD and anxiety symptoms in OEF/OIF Veterans with PTSD and a history of TBI.   "
63585|NCT02453334|"     Phase III, multicenter, randomized, double-blinded, prospective study with two parallel     treatment groups. Patients who present to the hematologist/oncologist and satisfy all     inclusion and exclusion criteria will be eligible for participation in this 18-week study.   "
63586|NCT02453321|"     Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer     adequate or equal analgesia and may promote better performance in early rehabilitation     following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve     Block (FNB). A common feature of these studies has been the use of moderate to high     concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when     injected by a large motor nerve will inevitably cause weakness. However, the practice at our     institution has long been a continuous femoral nerve block (CFNB) with a lower concentration     local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have     performed several thousand CFNBs using this technique which has offered the advantage of     minimal motor weakness and adequate analgesia.      The primary goal of this study is to determine if our established practice of using a low     concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the     femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice     of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) -     infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local     anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the     48-hour postoperative period.      Definitions of the location of the adductor canal are debated heavily in literature, but they     seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3     of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will     require placement of the continuous ACB no more distal than 20cm cephalad to the superior     pole of the patella due to placement prior to surgery and the need to keep the dressing out     of the operative field. The CACB catheter will also not be placed any more proximal than 20cm     distal to the ASIS. In addition to other exclusion criteria, these measurements will create     an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella     distance (IPD) will be measured at the pre-operative interview on the day of surgery with a     measuring tape. External palpable landmarks of the Anterior superior iliac spine and the     superior pole of the patella will be used.      The primary outcome is based upon the ability to perform rehabilitation exercises     postoperatively to the extent that criteria for discharge can be met. The primary outcome     measured is the time at which a patient gains the ability to successfully perform a 75-feet     unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary     outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary     outcomes will be the number of days admitted prior to discharge, and average pain scores on     DOS, POD#1, and POD#2. The Day of discharge will also be used as a secondary outcome. Earlier     discharge is becoming a goal of almost all healthcare systems to minimize costs.   "
63587|NCT02453308|"     This study is an open-label randomised trial comparing standard ACT treatment with matching     triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and     tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1     site in Africa. There are 2 arm study groups that have 2 treatment arms each.      Study group A:      A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus     Amodiaquine for 3 days.      Study group B:      B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine     for 3 days plus Mefloquine hydrochloride for 3 days.      Study group C:      C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days     plus Mefloquine hydrochloride for 3 days.      According to the WHO guideline, all patients except for children under the age of 1 year or a     weight below 10 kilograms will also be treated with a single dose of low dose primaquine.   "
63588|NCT02453295|"     The specific objectives and research questions of the proposed study are:        1. a. Administer a group rehabilitation intervention to address loss and foster hope in 30          participants with upper and lower limb SLC --15 in an intervention group (IG), 15 in a          control group (CG) at each of two research sites (Montreal, QC and Saint John, NB) for a          total sample size of 60. Data about its impact will be collected by means of          audiorecording 8 intervention workshops at each site and administering questionnaires          (multiple timepoints).           b. Test the intervention - Main hypothesis: The intervention group will show          improvements in psychosocial well-being.        2. Assess feasibility (e.g., review our accrual strategies, randomization of participants,          and data collection) via the completion of process logs.   "
63589|NCT02453282|"     This is a randomized, open-label, multi-center, global, Phase III study to determine the     efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy     versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal     growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced     or metastatic NSCLC   "
63590|NCT02453269|"     The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program     against childhood obesity.   "
63592|NCT02453243|"     Many patients at risk for suicide are discharged from the ED with little or no intervention.     Evidence-based suicide prevention interventions, like universal screening and safety planning     should be adopted in clinical practice to help prevent suicidal behavior. This study will     test the long-term sustainability of the nurse administered universal screening implemented     in the original ED-SAFE study. Also, the investigators will test what impact implementing a     new personalized Safety Planning Intervention guided by Lean has on suicide composite     outcomes.      The ED-SAFE-2 will use a stepped wedge design where the original eight ED-SAFE sites will     collect quantitative and qualitative data during the three phases: Baseline, Implementation,     and Maintenance. Using this data, as well as data from the original ED-SAFE study, the     ED-SAFE-2 will examine both within and between site differences for existing screening     practices and new safety planning procedures. Most of the data collection on outcomes will be     done by retrospective chart review.      The Safety Plan Intervention will be adopted into routine clinical care for patients who     screen positive but are set to be discharged. Each step is presented by the clinician and the     responses are recorded on a templated form. After completion of the safety plan, the     clinician helps the patient identify the most helpful aspects of the plan, ascertains the     likelihood of actually using it, and addresses any potential barriers to use. The patient     keeps the safety plan to use as a reminder during times of escalating distress or crisis.      A Lean Implementation Strategy will be used to ensure that adoption of the intervention is     fully supported vertically and horizontally within the organization, infrastructure is built     that supports the efforts, and that the protocols fit naturally within roles,     responsibilities, and clinical flow.      Consistent with the RFA's emphasis, the intervention target will be the clinician's behavior     of safety planning. All emergency mental health and nursing personnel at the sites will be     trained on safety planning, and Lean will be used to help ensure the safety planning is being     implemented properly and consistently. The mechanisms of action of the combination of the     safety planning training and Lean will be studied, allowing the team to establish both the     effect the intervention has on the intervention target but also on the mechanisms of action     comprised of departmental culture change and infrastructure support.   "
63593|NCT02453230|"     Since the 1960's, perinatal mortality in the United States has been declining at a steady     rate. This decline has thought to be the result of improved surveillance of normal and     abnormal fetal behavior and using that information to determine those babies at risk for     stillbirth.      There are many tools available for surveillance. One of these tools, the bio-physical profile     (BPP), incorporates a non-stress test (NST) with ultrasound assessment of fetal behavior .     This test has been used for about the last 30 years with good safety and efficacy. The     ultrasound evaluation includes monitoring fetal breathing, fetal gross and fine movement and     amniotic fluid evaluation. NST and BPP have been found to have similar ability to predict     fetal well-being, with similar safety and ease of performance. Several studies have observed     the effect of sound as well as light on the NST and have found that it can shorten testing     time without altering its ability to be interpreted properly or affecting fetal safety.     However, similar studies have not been done with the BPP. Light stimulation has been proven     to be safe for both the mother and the fetus with no harm having been demonstrated when used     with NST.   "
63594|NCT02453217|"     The investigators programme of research will evaluate an existing physical health care     screening intervention with the aim of helping Community Psychiatric Nurses (CPN) to improve     the physical health wellbeing of people with a SMI.      This pilot clustered randomised controlled trial aims to establish the potential efficacy and     acceptability of the Chinese Health Improvement Profile (CHIP) in improving the physical     health of people with severe mental illness.   "
63595|NCT02453204|"     Research has shown that reducing the time spent sitting can reduce the risk of many diseases,     such as diabetes and heart disease, and improve health. It is estimated that many older     adults typically spend 70% of their waking day sitting, but little is known about whether     reducing sitting promotes health and well-being in this age group. The aim of this research     is to investigate the health effects of reducing sitting time by replacing it with short     periods of standing or walking in adults over the age of 65.   "
63596|NCT02453191|"     The purpose of this research study is to determine the safety and tolerability of talimogene     laherparepvec when combined with radiation therapy.      Approximately 32 people will take part in this study conducted by investigators at the     University of Iowa.   "
63597|NCT02453178|"     Although exercise is known to delay cognitive decline and decrease our risk of Alzheimer's     Disease, there is a lack of understanding of how exercise protects the aging brain. The     proposed research takes a novel approach to this problem by testing the concept that there     are acute, direct effects of exercise in the same brain regions that are affected by chronic     exercise training. If the investigators are successful, the acute paradigm will allow us to     determine the critical exercise parameters that modulate brain function in humans using only     a single exercise dose.   "
63598|NCT02453165|"     Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.      The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault     at the end of a total laparoscopic hysterectomy, in order which of these two modalities of     suturing is associated with a lower risk of dehiscence.   "
63599|NCT02453152|"     This study is a longitudinal study evaluating the severity and progression of respiratory     muscle function in patients with X-Linked Myotubular Myopathy (XLMTM) aged 0-14.   "
63600|NCT02453139|"     Obesity, known to be associated with a pro-inflammatory, pro-thrombotic humoral milieu,     confers a worse prognosis in prostate cancer (PrCa). Circulating tumour cells (CTCs) are     identified in the blood in advanced cancer. Their quantitation provides prognostic     information. Cloaking of CTCs by adherent platelets impedes natural killer (NK)-cell     clearance of CTCs from the circulation, enhancing metastatic spread. NK-cell function in     blood and in solid organs is quantitatively and qualitatively reduced in obesity. Platelet     cloaking may be enhanced in obesity due to the pro-inflammatory, pro-thrombotic state, and     may be a mechanism for worse cancer-specific outcomes in this group. Obesity and its     biochemical effects may be influenced by lifestyle changes such as exercise. Physical     activity reduces levels of systemic inflammatory mediators and so an aerobic exercise     intervention may represent an accessible and cost-effective means of ameliorating the     pro-inflammatory effects of obesity. The ExPeCT trial will determine if a prescribed exercise     intervention can ameliorate the degree of platelet cloaking in obese and non-obese men with     advanced prostate cancer.   "
63601|NCT02453126|"     This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis     (EoE) is characterized by abnormal esophageal structure and compliance compared to non     fibrostenotic EoE and that distinctive cellular and molecular profiles predict the     fibrostenotic phenotype. This study aims to define and assess the changes that occur in the     structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along     with characterizing the histologic and molecular patterns in fibrostenotic EoE.   "
63605|NCT02453074|"     The purpose of this study is to design and test the feasibility of a system to survey     patients regarding the outcome of acute care visits and to report back to the healthcare     providers.   "
63606|NCT02453061|"     In the study the investigators plan to include 100 early affected HD patients (5 ≤ UHDRS ≤     40) in a randomized, double-blind, controlled study in 2 centers (France and the     Netherlands). Patients will receive either triheptanoin at 1g/kg of body weight per day (n =     50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an     open label phase using triheptanoin for another 6 months. Efficacy of triheptanoin will be     evaluated by measurements of caudate volume using volumetric magnetic resonance imaging and     brain energy metabolism as evaluated by the ratio of inorganic phosphate/phosphocreatine,     during visual stimulation, using 31P-MRS. Clinical improvement will be evaluated by UHDRS,     TFC, and PBA-S scores as well as performance on the neuropsychological battery; patient     quality of life will be evaluated with qualitative research methods after 6 months and with     the SF-36 questionnaire before and after treatment; biological tolerance and compliance will     be evaluated by routine biochemical blood tests, plasma and urine measurements of     triheptanoin oil derivatives and patient report.   "
63607|NCT02453048|"     This study evaluates the safety and immunogenicity of a higher dose formulation of a new live     attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal     colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce the     live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose), single     centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis strain     BPZE1 given as a single intranasal dose to healthy adult volunteer.   "
63608|NCT02453035|"     The X-Pand Registry is intended to facilitate analysis of acute & long-term safety as well as     treatment outcomes with DESolve in patients with CAD.   "
63624|NCT02452827|"     In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been     found in pathological studies. The physiologic function of these fibers is still unknown.     Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers     undergo changes in patients suffering from primary chronic neck pain. In addition, the     biomechanical parameters of neck movements in these patients will be correlated with the     imaging findings.   "
63625|NCT02452814|"     Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of     Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic     Hepatitis C Virus Genotype 1 Infection   "
63609|NCT02453022|"     The current study will help to increase our understanding of the pharmacokinetics (PK) of     danirixin. The primary objective of the study is to estimate the relative bioavailability of     danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and     tolerability information for oral administration of danrixin HBr tablets in elderly subjects     will also be obtained. Secondarily, this study will evaluate effect of food on PK of     danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of     danirixin HBr. The outcome of this study will contribute to the selection of the most     appropriate formulation/dosing regimen for future studies.      This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy     elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The     Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will     be done within 3 to 10 days post last dose.   "
63610|NCT02453009|"     The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to     improve the disease control in first line CRPC patients.   "
63611|NCT02452996|"     In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients     will be evaluated in healthy male volunteers.   "
63612|NCT02452983|"     This study will investigate the effects of sertraline in people with low-risk myelodysplastic     syndrome (MDS). It is hoped that sertraline will decrease disease progression and reduce the     need for blood transfusions.   "
63613|NCT02452970|"     The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic     agent, which turns on a number of beneficial genes that the tumor has silenced, can     resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and     cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label     study, which means that patients will know what treatments they are receiving, is EPIC, a     hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and     Cholangiocarcinoma.      The study treatment is divided into two stages. During the first stage, patients will receive     RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At     that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as     long as the tumors respond to them to determine whether resensitization has occurred.      The primary objective of this clinical trial is to evaluate the progression-free survival     (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.   "
63614|NCT02452957|"     The aim of this observationnal post-marketing study is to provide additional information on     the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty ,     in usual surgical practice.   "
63615|NCT02452944|"     Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder     tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can     trigger an inadvertent adductor muscle spasm, which can cause a serious complication like     bladder perforation.      General anesthesia with muscle relaxants for TURB does not guarantee a prevention of the     adductor muscle spasm. Spinal anesthesia with selective obturator nerve block (ONB) can be an     alternative anesthesia for TURB, but adductor spasm can also be induced because of incomplete     ONB. Recently, ultrasound guidance with nerve stimulator has been used to enhance the safety,     efficacy and shortening the onset time of ONB.      Some papers describe that comparable ONB can be done using ultrasound only without nerve     stimulator, in which there is a principle that obturator nerve runs along a given pathway.     Basically, obturator nerve is divided into two branches after exiting the obturator canal.     The anterior branch is located in the fascial planes among adductor longus, adductor brevis     and pectineus muscles, and the posterior branch is located between the adductor brevis and     adductor magnus muscles at the inguinal area. But it has been known that there are many     branching patterns of obturator nerve and high anatomic variability in the inguinal area in a     cadaver study. And subdivisions of obturator nerve in the inguinal area have been described.      Therefore, this study was conducted to investigate the success rate of ultrasound-guided     obturator nerve block with interfascial injection approach group (US-IFI; experimental group)     was comparable to ultrasound-guided obturator nerve block with nerve stimulating approach     group (US-NS; control group) in TURB under spinal anesthesia. And we also evaluated adductor     muscle twitching patterns at the inguinal region when the ONB was performed.   "
63616|NCT02452931|"     This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension     for treatment of children with Central Precocious Puberty.   "
63620|NCT02452879|"     The purpose of this study is to determine whether electroacupuncture is effective in the     treatment of overactive bladder.   "
63623|NCT02452840|"     The purpose of this prospective observational study is to assess the potential clinical     effects of adjunctive verteporfin photodynamic therapy (PDT) for persistent disease activity     among patients with neovascular age-related macular degeneration (NV AMD). No specific     interventions will occur as part of the study; participating subjects undergoing PDT as part     of standard-of-care will be asked to consent to prospective collection of data from their     medical records for up to five years from the date of consent, including results from     ophthalmologic exams, imaging, and treatments. The primary study outcome will be the     percentage of subjects with resolution of persistent disease activity at six months post-PDT     treatment. Aside from a small risk of loss of confidentiality, risks associated with this     study are no greater than those related to standard of care.   "
63626|NCT02452801|"     This study will evaluate the effect of various degrees of hepatic function on the     pharmacokinetics and safety of ALKS 5461.   "
63628|NCT02452775|"     This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide     and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine     (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube,     or primary peritoneal cancer.   "
63629|NCT02452762|"     Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health,     inflammation, innate immunity, and neuromuscular function have led to the hypothesis that     deficiency might represent a modifiable risk factor for outcomes in critical illness. In     recent years, dozens of adult studies have reported both high deficiency rates, and     associations between lower vitamin D levels and organ dysfunction, health resource     utilization, and mortality in the intensive care unit (ICU). More recently, similar     observations have been made in critically ill pediatric populations. The cumulative body of     basic science and clinical literature demonstrates that deficiency is common in critical     illness and rapid normalization of vitamin D status could improve clinical outcomes and/or     reduce health care costs. However, before conducting a phase III trial to determine whether     restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen     must be identified. Consequently, the investigators propose a phase II, double blind     randomized controlled trial to determine a loading therapy dosing regimen that can safely and     rapidly normalize vitamin D status in critically ill children.   "
63630|NCT02452749|"     This single-arm, open-label study will assess the safety and tolerability of one daily tablet     of a commercially available cardiovascular health dietary supplement by questionnaire and     blood markers in adults with borderline to mild hypertension over a 6 month period. Although     the cardiovascular health dietary supplement being investigated has been on the market for     over 20 years, prospective safety data and blood markers of end organ function have not     previously been reported.   "
63631|NCT02452736|"     The purpose of this study is to conduct a prospective, multi-center, single arm,     non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for     percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of     2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent     System.   "
63632|NCT02452723|"     This study will evaluate the safety of an investigational cell transplantation therapy,     ISC-hpNSC, in patients with Parkinson's disease. All patients will receive the therapy, which     consists of human neural stem cells. Three dose levels will be examined in the study.   "
63633|NCT02452710|"     This research study is evaluating the usefulness of a placebo (a tablet with no active     ingredients) on fatigue in cancer survivors.   "
63634|NCT02452697|"     This is a randomized, parallel phase II study to evaluate the rates of progression-free     survival and unacceptable toxicity in patients receiving NK cell-enriched donor lymphocyte     infusions (DLIs) when administered alone or administered with the TLR9 agonist, DUK-CPG-001,     from a 7-8/8 HLA-matched related or unrelated donor (Cohort A) or 4-6/8 HLA-matched related     donor (Cohort B) following reduced intensity or non-ablative allogeneic stem cell     transplantation. Randomization will be stratified for disease types (myeloid versus lymphoid     malignancies). Primary endpoints are analyzed separately in Cohort A and B.      Cohort A: 7-8/8 HLA-matched related or unrelated donor (NK cell enriched-DLI only arm or     NK cell enriched-DLI + DUK-CPG-001 arm)      Cohort B: 4-6/8 HLA-matched related donor (NK cell enriched-DLI only arm or NK cell     enriched-DLI + DUK-CPG-001 arm)   "
63635|NCT02452684|"     To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in     insomnia patients.   "
63636|NCT02452671|"     This is a multi-center, non-randomized, observational study to further evaluate the     effectiveness and safety of the Proxifuse Hammer Toe Device when utilized for bone fixation.     Approximately 4 US sites will participate. The primary endpoint will evaluate the 6 month     post surgery change from baseline in the PROMIS Pain Interference computerized adaptive test     (CAT) score.   "
63637|NCT02452658|"     Participants will be exposed to a hypothetical fast food menu, asked to place a hypothetical     lunch order, and will then be exposed to a second menu with several changes made to the menu.     Participants will be asked to identify as many changes as possible on this second menu, and     then complete a survey about their eating tendencies and demographics.   "
63648|NCT02452515|"     The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor     BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable     patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo     will be given on top of evidence-based standard of care for left-ventricular dysfunction     after myocardial infarction. Primary objectives are the analysis of safety and tolerability     as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered     in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily).     Each dose group consists of 9 patients treated with verum and 3 patients treated with     placebo.   "
63660|NCT02452359|"     This trial is intended to evaluate the effect of IPL treatment on the Striae Distensae. The     study hypothesis is that the SR580 applicator will improve the appearance of Striae Distensae     by at least 1 point on the Global Aesthetic Improvement ScaleI (GAIS) at 3 months follow-up     compared to baseline in at least 50% of the study population.   "
65950|NCT02422446|"     This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid     (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention     among adults with elevated triglycerides and type 2 diabetes.   "
63638|NCT02452645|"     Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual     Principal Investigators for this project. The research team will first conduct formative     research using focus groups and key-informant interviews of Family Child Care Home (FCCH)     providers. This formative work will inform our adaptation of components of previous     evidence-based interventions to create a new innovative intervention in both English and     Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The     intervention will integrate: a) support from peer counselors with child care experience who     will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c)     a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the     effectiveness of the intervention with a Steering Committee and Community Advisory Board     guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to     inform the development and adaptation of the FCCH intervention. 2) Conduct a     cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control     intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a)     Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at     FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods     will include survey data collection of the FCCH Providers; observation of children's' dietary     intake and physical activity in FCCHs; recruitment of children within the FCCH for physical     and survey measurement with permission from their parents.   "
63639|NCT02452632|"     The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in     combination with metformin and sitagliptin against placebo in combination with metformin and     sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with     inadequate glycemic control on metformin and sitagliptin.   "
63640|NCT02452619|"     In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen     therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging     studies before and after treatment.      The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in     addition to the cognitive tests before and after the treatment.   "
63642|NCT02452593|"     Urinary incontinence is defined according to the International Continence Society as any     involuntary loss of urine, which may bring several negative consequences on women's lives,     and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20%     emergency.      The overactive bladder present in urge incontinence and mixed cause significant impacts on     people's lives and has a prevalence of 16.5% in the US population.      Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment.     Drug therapy using drugs which are not specific for the bladder and are associated with many     unwanted systemic side effects.      The results obtained by researchers in several countries using conservative techniques in the     treatment of patients with urinary incontinence are encouraging and this study aims to     evaluate carefully and systematically the effectiveness of tibial stimulation technique.      Importantly, also, that conservative techniques have lower cost than the surgical treatment     and have virtually no side effects as most of the drugs used in the pharmacological treatment     of female urinary incontinence.   "
63643|NCT02452580|"     This study evaluates possible effects of two different NICU designs; by comparing traditional     and Family Centered Care in terms of infant nutrition, health and growth, and coping by     family.   "
63644|NCT02452567|"     Obesity is associated with a constellation of cardiometabolic abnormalities (including     insulin resistance, elevated blood pressure and dyslipidemia) that are risk factors for     diabetes and cardiovascular disease. Weight loss can improve all of the cardiometabolic     abnormalities associated with obesity. Up to ~25% of lean people (Body Mass Index[BMI]     18.5-24.9kg/m2) have many of the cardiometabolic abnormalities associated with obesity and     are referred to as metabolically abnormal lean (MAL) people. However, the MAL phenotype is     not well characterized and it is unclear whether weight loss has beneficial metabolic effects     in already lean people. Accordingly, the goal of this study is to: 1) carefully phenotype MAL     people and 2) evaluate the effect of moderate (8-10%) diet-induced weight loss in MAL people.     This will be investigated in 15 MAL (defined as intrahepatic triglyceride (IHTG) content     ≥5.6% and glycated hemoglobin ≥5.7%, or fasting plasma glucose concentration ≥100 mg/dl, or     2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl) men and     women. Only lean people who have a BMI>/= 21.0 but <25.0kg/m2 will be asked to lose weight to     avoid the risk that participants become underweight (BMI <18.5kg/m2) during weight loss     therapy..   "
63645|NCT02452554|"     This phase II trial studies how well lorvotuzumab mertansine works in treating younger     patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma,     malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or     that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab     mertansine, are created by attaching an antibody (protein used by the body's immune system to     fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to recognize     tumor cells so the anti-cancer drug can kill them.   "
63646|NCT02452541|"     Severe traumatic brain injury (TBI) is the leading cause of death and disability among people     under 45 years of age and a major public health problem. Although management of severe TBI     patients has gradually improved with the establishment of intensive care units (ICU) and the     development of practice guidelines, mortality is still high - ranging from 30 to 50% - with     30% of survivors suffering from severe neurological sequelae such as neurovegetative states.     Families and medical teams are frequently called upon to determine reasonable and appropriate     goals of care for brain injured patients. They may have to consider high intensity of care,     but also the withdrawal of life-sustaining therapies in accordance with patient wishes.     Physicians involved in the care of severe traumatic brain injury have expressed serious     concerns about hasty decisions made in the absence of appropriate evidence of unfavourable     prognosis. The purpose of the TBI-Prognosis study is to develop a prognostic model by using a     multimodal approach of different prognostic indicators and their evolution over time in the     acute phase of care. The results of this study will provide better objective information that     will facilitate the shared-decision making-process with families and relatives.   "
63647|NCT02452528|"     Patients with chronic Hepatitis B Virus (HBV) infection will receive multiple doses of     ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.   "
63649|NCT02452502|"     Emerging studies have shown that statin treatment has pleiotropic non-cholesterol-dependent     effects in the setting of ischemic stroke.      Recombinant tissue plasminogen activator (rt-PA) is the only proven effective pharmaceutical     treatment for hyper-acute management of ischemic stroke, in spite of the deleterious     side-effects such as hemorrhagic transformation and reperfusion injury. These harmful impacts     can be counteracted with proper neuro-protective therapy. In fact, the simultaneous use of an     effective neuro-protective agent was proved to reduce the comorbid vascular injury of rt-PA.     In experimental research, high dose of atorvastatin combined with rt-PA can significantly     reduce infarct volume and improve the neurologic deficits. Previous studies showed that fewer     than 40% ischemic stroke patients established early reperfusion after intravenous     thrombolysis, while high dose of atorvastatin was revealed to favor the maintenance of     cerebral vascular patency and integrity, most likely by reducing thrombosis secondary to     rt-PA administration. Moreover, it was suggested that statin can sufficiently improve the     restoration and remodeling of neurovascular unit in cerebral cortex.      Investigators thus design this study to prospectively investigate whether high dose of     atorvastatin prescribed within 24 hours after IV-thrombolysis will have a synergic effect to     improve neurological outcome in acute ischemic stroke patients. Moreover, investigators     deemed it necessary to non-invasively monitor neuronal and vascular morphological changes in     brain as an indication of functional improvement. In the investigation centers, investigators     have developed and implemented novel multimodality MR imaging which can dynamically monitor     neurovascular remodeling. Therefore, it is worthwhile to evaluate these MRI measurements for     early prediction of neurovascular reorganization with long term functional recovery in     thrombolytic stroke patients administrated with high dose of atorvastatin.      The primary target of this study is to prospectively investigate whether high dose of     atorvastatin (80mg) administrated within 24 hours after IV-thrombolysis will have a synergic     effect to improve neurological outcome in acute stroke patients, versus moderate dose.   "
63702|NCT02451813|"     Recent evidence suggests that injection pressure monitoring may be able to predict needle     nerve contact in the brachial plexus nerve block model, but little is known about     multifascicular nerves. The investigators hypothesize that injection pressure monitoring can     reliably predict needle-nerve contact during femoral nerve block.   "
63650|NCT02452489|"     With Diabetic gastroparesis as the research object, by the method of multi-center RCT and     single cavity and different acupuncture acupoints compatibility treatment of diabetic     gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as     validity checking means, for single cavity with different acupoints compatibility evaluate     clinical efficacy of treatment of diabetic gastroparesis.   "
63651|NCT02452476|"     A multicenter, double blind, randomized, single dose, active-controlled study to investigate     the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine     surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory     distress syndrome. Main objectives of this study are to investigate the short term efficacy     profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced     oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in     terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36     weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated     mortality through 14 days of age and other major co-morbidities of prematurity.      Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either     sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with     RDS, requirement of endotracheal surfactant administration within 24 hours from birth,     fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for     babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%.   "
63652|NCT02452463|"     This randomized phase II trial studies the side effects and how well nintedanib works     compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the     lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are     undergoing chemoradiation therapy. Nintedanib may help shrink or slow the growth of     radiation-induced pneumonitis by blocking some of the enzymes needed for cells to grow and     may prevent the growth of new blood vessels. It may also help reduce the recurrence of     non-small cell lung cancer.   "
63653|NCT02452450|"     The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol     formulations.   "
63654|NCT02452437|"     To measure oxycodone's intradialytic mass transfer rate coefficient and oxycodone's removal     rate using an ODE/PDE hemodialysis model. To implement a rational clinical strategy for     estimating a patient's post-hemodialysis oxycodone restoration dose using results from an     ODE/PDE model of hemodialysis.   "
63655|NCT02452424|"     The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work     together to affect cancer cells.      PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to     block the interaction between the receptor PD-1 and molecules that bind PD-1. In this study,     PLX3397 and pembrolizumab are being given together in order to study their combined effects     on patients' immune responses to their tumors. Tumor-specific immune responses have been     shown to kill cancer cells and/or to stop tumors from growing.      Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be     given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include     an evaluation of efficacy of this combination in the following tumor types:        -  Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded        -  Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as          defined by irRECIST while on therapy        -  Non-small cell lung cancer        -  Ovarian cancer        -  Gastrointestinal Stromal Tumor (GIST)        -  Squamous cell cancer of the head and neck   "
63656|NCT02452411|"     The purpose of this study is to determine the differential efficacy of two ways of applying     homework assignments in the treatment of Adjustment Disorders: 1) using an Internet-based     emotional regulation therapy system (TEO) and 2) in the traditional way (using reading and     audio materials).      The principal hypothesis is that both treatment conditions (TEO and Traditional) will show a     similar efficacy. All participants will improve significantly on all outcome measures,     regardless the type of homework assigned (TEO or Traditional) with no differences between     them.   "
63657|NCT02452398|"     This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent     hair reduction and removal for skin types V and VI using IPL.   "
63658|NCT02452385|"     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and     Pharmacokinetics of CM082 tablets in Chinese Patients With wet-AMD.   "
63659|NCT02452372|"     The purpose of this study is to evaluate the safety and tolerability of ALN-AS1 in AIP     patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of     ALN-AS1 in AIP patients.   "
63661|NCT02452346|"     Study WCMC IST-CTI-MDS evaluates the safety and tolerability of tosedostat in adult patients     with pathologically confirmed MDS (< 20% blasts in bone marrow, peripheral blood, or both) by     World Health Organization (WHO) classification after failure of hypomethylating agent-based     therapy.   "
63662|NCT02452333|"     Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness     and oncologic success of oncoplastic methods and even modified variants of these methods     reinforced with videoscopic applications. However, primary lumpectomy subjects in these     studies are mainly patients who have already received the diagnosis of malignancy before the     surgery. There is not much comprehensive work reported for patients without the diagnosis of     malignancy. In this regard, the investigators believe the intent of the innovative     oncoplastic intervention to the breast is underestimated in terms of providing diagnosis     simultaneously constituting the basic component of surgical treatment. Thus, the purpose of     this prospectively planned study is to provide and investigate the outcomes of an     evidence-based oncoplastic approach algorithm for excisional breast biopsies.   "
63703|NCT02451800|"     The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga     program on increasing compliance and improving weight loss while participating in the Sanford     Profile program. Participants are randomized to one of three groups: in-class yoga, yoga by     digital video disk (DVD), stretching by DVD. Changes in weight loss and stress levels are     monitored.   "
63663|NCT02452320|"     The purpose of this study is to determine if the administration of acetaminophen given     intravenously (through an IV) beginning during surgery and then for 3 additional doses during     the first 24 hours post-operatively will reduce the length of time subjects undergoing     elective sleeve gastrectomy spend in the hospital following this operation. Additional     questions that may be answered include whether administration of the study medication leads     to improvement in pain control, a reduction in post-operative nausea and vomiting, and an     overall improvement in quality of recovery.   "
63664|NCT02452307|"     The study evaluates the prostate-specific antigen (PSA) response in HLA-A*02 positive     patients with biochemical recurrence after radical prostatectomy treated with a     prostate-specific peptide vaccine in combination with different immune-adjuvants.   "
63665|NCT02452294|"     The study will enrol adult female and male patients with BRAF wild-type melanoma and brain     metastases who are not eligible for surgery or radiosurgery and failed prior therapy with     ipilimumab, and patients with BRAF V600 mutation-positive melanoma and brain metastases who     are not eligible for surgery or radiosurgery and who failed prior therapy with a BRAF     inhibitor.   "
63666|NCT02452281|"     The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is     safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational     vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the     cancer's fingerprint. Injection of the vaccine may cause the patient's immune system to     recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug     approved by the FDA for the treatment of metastatic melanoma that boosts immune response.   "
63667|NCT02452268|"     Phase I/Ib multicenter clinical trial. Single agent dose escalation of NIZ985 followed by     expansion. Second escalation of NIZ985 in combination with PDR001 followed by expansion   "
63668|NCT02452255|"     The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate     plus propranolol have therapeutic, physiological, and metabolic effects that will improve     clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.   "
63669|NCT02452242|"     ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is     intended to assess the safety, the tolerability, and pharmacokinetic parameters and to     evaluate the effect on viral load of repeated oral administrations of ABX464 in patients     infected by HIV, not previously treated for their HIV.      Two types of design are intended in this protocol: dosing every 3 days or dosing every day.     The goal is to determine the best dosing regimen to reduce viral load and minimize adverse     events.   "
63670|NCT02452229|"     Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to     play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing     systematic review (Level of Evidence III or higher) describing the unique role as well as     concurrent infections of these viruses in burns. The aim of this review is to point out the     clinical differences between these human herpes virus subtypes, to outline established     therapy approaches, and to provide evidence for virus related morbidity and mortality in     burns.   "
63672|NCT02452203|"     The studies proposed in this protocol aim to explore the anxiolytic properties of floating as     it relates to the central and autonomic nervous system.   "
63673|NCT02452190|"     The primary objective of this study is to determine the effect of reslizumab (110 mg)     administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and     adolescents with asthma and elevated blood eosinophils who are inadequately controlled on     standard-of-care asthma therapy.   "
63674|NCT02452177|"     Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The     mechanism for this injury has two possible explanations. The first possible reason is     intrinsic toxic effects of parenteral nutrition. The second is the basic pathological     condition of intestinal failure which includes infection, bacterial translocation, etc.     Cholestasis is the lethal presentation of this kind of liver disease. Farnesoid X receptor     (FXR) is a member of ligand-activated nuclear receptor superfamily. FXR serves as a sensor     for bile acids and promotes enterohepatic clearance of bile acids by controlling the     expression of genes involved in their transport and metabolism. Considering the activation of     vitamin D receptor (VDR) by vitamin D can induce FXR-related genes in the liver.The     hypothesis of this study is that vitamin D plays a key role in the prevention and reversion     of the liver via VDR and/or FXR signaling pathway. Using a mouse cholestasis model based on     short bowel syndrome and parenteral nutrition, the researchers will investigate the dynamic     change of plasma vitamin D level. Afterward, intravenous supplement of vitamin D was added to     this model to demonstrate vitamin D can ameliorate cholestasis. An in vitro system was     developed to investigate the importance of FXR signaling pathway in this effect.   "
63675|NCT02452164|"     This is a one-center clinical study carried out in Turku, Finland. The study patients will be     randomly allocated to one of the two parallel study groups (teaching group and control     group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better     when parents have been taught to conduct middle ear examination with a cellphone otoscope     (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the     diagnostic feasibility of cellphone otoscopy.   "
63704|NCT02451787|"     The investigators major aims are to: determine the vitamin D status of a group of young,     apparently healthy adults in Hong Kong; examine inter-relationships between vitamin D status     and biomarkers of DNA damage and repair, oxidative stress, inflammation and endothelial     health; and, in part 2 of the study, investigate effects of improvement in vitamin D status     on these biomarkers and other measures of well-being in those young adults shown to be     deficient in vitamin D.   "
63677|NCT02452138|"     Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response     syndrome induced by gram-negative bacteria infection. The endotoxin related inflammatory     response and hypercoagulation can result in microcirculatory dysfunction. When     microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome and     death. This is a prospective observational study, and it will not influence the sepsis     treatment decision of the medical care team. The critically ill severe sepsis patients will     be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and     sign the consent form after explanation of the aim and process of the trial by the primary     investigator or research personnel. After enrollment, the patient will receive serum assay of     endotoxin activity (EAA) and endocan level. The patient will also receive examination of     sublingual microcirculation by using the incident dark field video microscope. After 24     hours, the patient will receive assay of endocan level and examination of sublingual     microcirculation. This study will record the vital signs, laboratory data, dose of     vasopressors and inotropic agents, and severity of organ dysfunction. After 28 days, this     study will check the survival, stay of intensive care, stay of hospital, ventilator day, and     the results of culture of pathogens. The patients will be assign to the following three     groups by the EAA level: low EAA group (< 0.40 EAA units); intermediate EAA group (0.40-0.59     EAA units); and high EAA group (≧ 0.60 EAA units). This grouping will be used for statistical     analysis and comparison. The primary goal of this study is to investigate the difference of     the prevalence of gram-negative bacteria infection, pathogen, infection source,     microcirculation, the severity of disease, and the prognosis among these three groups.   "
63678|NCT02452125|"     The objective of this experiment is:      To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension     in PD subjects.   "
63679|NCT02452112|"     This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy     and safety of 5% lidocaine patch, following placebo or active patch applications in placebo     insensitive subjects.   "
63680|NCT02452099|"     The main aim of the study was to evaluate the clinical impact of different DMSO     concentrations in cryopreservation mixture (5%, 7.5%, 10%) on reconstitution of hematopoiesis     after autologous hematopoietic stem cell transplantation.   "
63681|NCT02452086|"     The purpose of this study is to examine the changes of factors including Vascular Endothelial     Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α),     measurements of oxygen saturation in peripheral blood and wound surface area and     ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser     Therapy(LLLT).   "
63682|NCT02452073|"     Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the     level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due     to the dosage of radiation, sensitivity of organs to radiation, and some patient     characteristics, RE can present as either an acute or chronic syndrome. Clinical     manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia,     intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For     many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant     percentage of patients with rectosigmoid and genitourinary system tumors. Different     techniques have been developed to prevent the occurrence of radiation induced injury.     However, the incidence of CRE is expected to continue to rise during the coming years. What's     more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE,     such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention     is only paid to local complications, there is little report on systemic damage of abdominal     or pelvic radiotherapy.      Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating     triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and     thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is     variously known as the nonthyroidal illness syndrome (NTIS). This condition is frequently     detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid     hormone metabolism might change during many chronic illnesses as early as 1973. Data has     shown that about 35-70% of acute and chronic critical conditions were associated with a     significant abnormal thyroid hormone metabolism, of which LT3S was the most common type.     Furthermore, these changes have been shown to be associated with disease severity and have     been connected with poor short-term prognosis.      To date, there are lots of literatures include detailed reports on the relationship between     LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus,     sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been     undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE     patients.   "
63683|NCT02452060|"     This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center     study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18     and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and     consented during the preadmission visit prior to surgery.   "
63684|NCT02452047|"     The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A)     versus colistimethate sodium + imipenem+cilastatin in the treatment of imipenem-resistant     bacterial infections. Infections evaluated in the study will be hospital-acquired bacterial     pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated     intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI).   "
63685|NCT02452034|"     This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered     intravenously (IV) or orally to immunocompromised pediatric participants.   "
63686|NCT02452021|"     This is a prospective observational study designed to observe the toxicity and efficacy of     PBS proton RT for patients with esophageal cancer undergoing trimodality therapy. The     investigators hypothesize that PBS proton RT will be associated with a favorable adverse     event profile and quality of life, with similar disease control outcomes, relative to     historical comparisons of patients treated with photon RT.   "
63687|NCT02452008|"     The primary objective of this study is to compare the progression free survival (PFS) of     patients with metastatic castration-resistant prostate cancer treated with enzalutamide in     combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).   "
63698|NCT02451865|"     This phase Ib trial studies the safety and best dose of binimetinib when given in combination     with docetaxel in treating patients with previously treated, stage IV non-small cell lung     cancer. Binimetinib and docetaxel may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
63699|NCT02451852|"     To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth     factor receptor T790M mutation-positive non-small cell lung cancer.   "
63717|NCT02451618|"     For any newborn that exhibits possible seizure activity or has altered mental status of     unknown etiology, continuous bedside EEG recording is the standard of care to detect     subclinical seizure activity. The experimental aspect of this study will be the application     of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a     continuous bedside recording of brain activity in the same manner as an EEG recording, while     ideally producing less irritation of newborn skin than conventional EEG electrodes.   "
63688|NCT02451995|"     Tachycardia's (fast heart rhythms) can lead to troublesome palpitations, dizziness, blackouts     and breathlessness. They are caused either by a cluster of abnormal cells within the heart,     or an electrical short circuit which rotates rapidly around the heart. Sometimes these can be     controlled with tablets, though owing to side effects many patients want something else. Many     tachycardia's can be cured by a procedure known as an ablation. In essence, either the     focus of abnormal cells or the narrowest point of the short circuit causing the abnormal     heart rhythm (the source) is electrically destroyed (burnt) resulting in restoration of the     normal heart beat.      One form of tachycardia is known is Atrial Tachycardia (AT). These arise from the top two     chambers of the heart (the atrium). Interestingly, this problem is frequently seen in     patients who have previously undergone an ablation or surgical procedure for a condition     called Atrial Fibrillation. In others the reason for its occurrence is unknown. Current     strategies to find the source during an ablation procedure are technically challenging     resulting in long procedure times. Sometimes the wrong source is found resulting in ablation     at the incorrect site.      Ripple Mapping (RM) is a novel system that Investigators at Imperial College are looking to     study. RM displays electrical information within the heart as a series of bars coming out of     the chamber, with each bar representing signals travelling down the heart. By seeing the     pattern of electrical information, they believe it will show the pattern of the tachycardia     better than conventional techniques. In a previous study that they conducted, RM found the     source of the tachycardia in 80% of the maps, compared to only 50% with the current system.     Investigators at Imperial College have identified why they did not get 100% and they believe     that, in future, RM will find the source of the tachycardia first time, and every time.   "
63689|NCT02451982|"     This study will be looking at whether CY/GVAX with nivolumab is more effective than CY/GVAX     alone in altering the pancreatic tumor microenvironment (IL17 expression) to aid in the     anti-tumor response.   "
63691|NCT02451956|"     This study is a single arm, single center phase II study of AZD5363 in combination with     paclitaxel in patients with advanced gastric adenocarcinoma harboring PIK3CA mutation or     amplification as a second line chemotherapy.      Patients will receive AZD 5363 plus weekly paclitaxel combination regimen. A arm is composed     of 25 patients.      Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to     first dose) and every 8 weeks relative to the date of enrollment, up to week 40, then every     16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled     date).      Study treatment will be continued until objective disease progression.   "
63692|NCT02451943|"     The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin     plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with     advanced or metastatic soft tissue sarcoma.   "
63693|NCT02451930|"     The main purpose of this study is to evaluate the safety and efficacy of the combination of     necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer     (NSCLC).   "
63694|NCT02451917|"     Chronic kidney disease (CKD) is one of the most common microvascular complications of     diabetes mellitus, and it is the leading cause of end stage renal disease on developed     countries. The CKD diagnosis and its progression require re-evaluation of hypoglycemic     therapy and constant dosing adjustments, in order to optimize glycemic control and minimize     its side effects. Long acting insulin analogs and its pharmacokinetics have not been studied     through different stages of kidney disease and there is no consensus defining the appropriate     dosing adjustment based on the glomerular filtration rate (GFR). This research project will     compare the glycemic response to intensive insulin treatment with NPH insulin and basal     insulin analog (insulin glargine) in type 2 diabetes (DM 2) patients with CKD stages 3 and 4.     Patients and methods - Inclusion Criteria: DM 2 patients with CKD secondary to diabetic     nephropathy and GFR of 15-59 ml/min/1.73m². Exclusion Criteria: Patients with systemic     neoplasia, HIV, CKD or nephropathy from other etiologies, severe psychiatric disorders and     pregnant women. Study design: This study consists of a randomized, cross-over, open-label     controlled clinical trial. Patients will be randomly divided into two groups: GROUP 1 -     insulin analog glargine once a day and GROUP 2 - NPH human insulin, three applications per     day, both group will be treated with insulin lispro at mealtime. The laboratory tests will be     performed at baseline and 3, 6, 9 and 12 months after the study start. During routine medical     appointments will be analyzed self- monitoring of capillary blood glucose (SMBG) and the     hypoglycemia score. After six months the basal insulin will be changed, i.e. patients using     NPH insulin will receive insulin glargine and patients on insulin glargine will be changed to     NPH insulin. A CGMS will be carried out at 6 and 12 months. Methodology: The metabolic     profile will be evaluated throughout SMBG; biochemical, hormonal and hematological     measurements; hypoglycemia score and CGMS. Statistical analysis will be performed using     comparative descriptive analyzes, such as chi-square distribution, t-test and non-parametric     tests. Analyze of data CGMS will include the area under the curve and the related statistic.     Finally, logistic regression models will be adopted to evaluate the effect of the treatment     on the several variables in question.   "
63695|NCT02451904|"     -  The aim is to describe disease mechanisms of severe and cerebral malaria and identify          new targets for adjunctive therapies.        -  Despite treatment between 10-30% of patients with severe malaria die.        -  Metabolic acidosis and cerebral malaria are major complications associated with          mortality across all age groups. Still, their underlying pathogenesis remains          incompletely understood.        -  Using a metabolomics approach, this study aims to characterise the spectrum of acids          accumulating during acidosis, and investigate patterns of metabolic dysregulation          associated with coma and seizures.   "
63696|NCT02451891|"     This is a clinical trial in which healthy volunteers will be administered experimental Ebola     vaccines. The investigators will vaccinate four groups of volunteers.      Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu.      Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA EBO     Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a dose     of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different     concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4).      The study will assess the safety of the vaccinations, and the immune responses to     vaccination. Immune responses are measured by tests on blood samples.      The cAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from     viruses which are modified so that they cannot multiply. The viruses have extra DNA in them     so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that     the immune system builds a response to Ebola without having been infected by it.      Healthy volunteers will be recruited in Oxford and London England. The study will be funded     by the Wellcome Trust.   "
63697|NCT02451878|"     The investigators will test the value of an internet self-help package (E-Couch) for     alleviating sub-clinical social anxiety symptoms in the general population. This is not a     treatment trial for social anxiety disorder (these people will be directed to seek other help     and excluded from this study). The investigators will undertake a randomised controlled trial     involving approximately 2000 people with symptoms of shyness and sub-clinical social anxiety.     The investigators will compare the effect of the E-Couch intervention compared to a wait-list     control condition. Over a period of 12 months the investigators will measure the effect of     using E-Couch self-help on social anxiety symptoms, as well as on mental wellbeing, and other     secondary outcomes including quality of life, depression and general anxiety, and their use     of other sources of help.   "
63718|NCT02451605|"     Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve)     for total replacement knee surgery.   "
63700|NCT02451839|"     For public health purposes disability is becoming increasingly important as an outcome     measure. Despite this, there are few data on the effectiveness of adalimumab on disability     outcomes in patients with Immune-Mediated Inflammatory Diseases (IMIDs), particularly in the     Phase IV setting. There are even less data available in New Zealand, which did not have the     opportunity to participate to a major extent in large, multinational, Phase III pivotal     studies of adalimumab in IMIDs.      The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple,     validated, free and easy-to-use generic assessment instrument for health and disability. It     is applicable across cultures, in all adult populations. It is a responsive measure that can     show what difference a treatment makes.      Results from study of effect of adalimumab on WHODAS scores and other Patient-Reported     Outcomes (PRO) of work activity and well-being will be of interest to a variety of     stakeholders in the healthcare system including patients, healthcare practitioners and     payers.   "
63705|NCT02451774|"     Recent advances in acute lymphoblastic leukemia treatment are based on a cytotoxic drug     combination. Measurement of minimal residual disease in bone marrow samples at day 14 of     treatment is the most powerful early predictive indicator of further relapse, and it can be     applied practically to all patients with acute lymphoblastic leukemia. Even more so, it has     been observed that patients who present negative minimal residual disease in bone marrow     samples at day 7 during induction have a better prognosis than those achieving this at day     14.      Relapse represents the main cause of treatment failure that related in the extreme with     resistance to apoptosis, defining the latter as the principal mechanism of programmed cell     death; it is also related with the induction of leukemic cells to senescent arrest.      Pentoxifylline is a methyl-xanthine byproduct considered an unspecific inhibitor of     phosphodiesterase. It inhibits nuclear factor-kappa-beta activation by different mechanisms     and stimulates apoptosis induced by different drugs; thus, it can optimize the antineoplastic     effect of actual treatments in order to increase the apoptosis of leukemic cells. This effect     might improve the prognosis of these patients.      Evaluate the safety and effect of Pentoxifylline together with antineoplastic drugs in order     to study increased apoptosis and decreased senescence during the remission induction phase in     pediatric patients with newly diagnosed acute lymphoblastic leukemia. To achieve this     propose, we will divide patients in two groups, who will receive pentoxifylline or placebo     depending on the group, in addition to conventional treatment according to the protocol     standard chemotherapy schema for pediatric patients with acute lymphoblastic leukemia at our     institution during the remission induction phase. In addition, we will test whether the study     group exerts an impact on reaching remission earlier as compared with the control group.   "
63706|NCT02451761|"     Apparently balanced chromosomal rearrangement (ABCR) associated with an abnormal phenotype is     a rare but problematic event. It occurs in 6% of de novo reciprocal translocations and 9% of     de novo inversions. Abnormal phenotype, including intellectual disability and / or multiple     congenital anomalies (ID/MCA) may be explained either by associated cryptic genomic     imbalances detectable by array-CGH or by gene disruption at the breakpoint. However,     breakpoint cloning using conventional methods (i.e., fluorescent in situ hybridization     (FISH), Southern blot) is often laborious and time consuming and cannot be performed     routinely. Without complete investigation of these rearrangements, genetic counseling is a     real challenge. Recently, the investigators and others showed that Next-Generation Sequencing     (NGS) is a powerful and rapid technique to characterize ABCR breakpoints at the molecular     level.      The ANI project (ABCR NGS ID) aims at characterizing at the molecular level ABCR in 55     patients presenting with intellectual disability and/or multiple congenital anomalies     (ID/MCA) using NGS. The investigators make the hypothesis that ABCR account for the patient     phenotype, either by gene disruption or position effect, since genomic imbalance would have     been previously excluded by array-Comparative Genomic Hybridization (CGH).      The ANI project is a 3-year-long study that will be conducted by a consortium of 21 partners,     including 19 french hospital cytogenetics laboratories, a research team (TIGER), and a     cellular biotechnology center. Patients will be recruited by each Cytogenetics laboratory.     ABCR breakpoints will be molecularly characterized by NGS and a first bio-informatics     analysis. The results will be verified by amplification of junction fragments by polymerase     Chain Reaction (PCR) followed by Sanger sequencing, allowing the localization of breakpoints     at the base-pair level. In some complex cases, FISH experiment will be necessary to clarify     the results. A second bio-informatics analysis will then determine breakpoints'     characteristics (sequence, repeated elements, gene and regulatory elements). Finally, for     each breakpoint, gene expression studies will be performed including the gene disrupted by     the breakpoint and two neighboring genes. All these data, together with those already     available in the literature and databases will be integrated to determine if the gene could     account for the patient's phenotype, allowing an appropriate genetic counseling.      This project will identify new candidate genes involved in ID and developmental anomalies. It     will also contribute to the development and evaluation of NGS as a diagnostic tool for ABCR     and ID/MCA. It will also allow unraveling mechanisms and functional consequences of ABCR, in     particular in term of position effect.      In conclusion, the ANI project will contribute to the improvement of diagnostic management     and genetic counseling of patients with ID/MCA and ABCR. It will also contribute to the     understanding of ABCR physiopathology and to the unraveling of pathway involved in     development and brain function, thus improving genetic counseling for ID/MCA patients in     general.   "
63707|NCT02451748|"     The purpose of the study is to better understand the factors present in the cells of inflamed     joints of patients with arthritis that may cause rheumatoid arthritis. Knowledge gained from     this study may lead to new and better therapies for arthritis.   "
63708|NCT02451735|"     The purpose of this study is to review and evaluate the effectiveness of new educational     materials (informational booklet & DVD) that promote participation in genetic counseling     among breast cancer survivors.      There are two phases to this study:      Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the     effectiveness of the newly developed educational materials   "
63709|NCT02451722|"     Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of     the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes     versus normal foot wear in diabetic and healthy subjects.   "
63710|NCT02451709|"     To determine whether electronic adherence monitoring with feedback and reminder alarms can     improve adherence and health outcomes in childhood asthma.   "
63711|NCT02451696|"     The purpose of this study is to measure if the drug called Everolimus effects mTOR signaling     (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex     (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be     undergoing brain surgery. One group of patients will be treated with Everolimus, and another     will not. Researchers will determine if there is a difference in mTOR signaling between the     patients who were treated with Everolimus and those who were not. Previous studies have     suggested that Everolimus may reduce seizure activity in TSC patients by decreasing mTOR     signaling. Since patients with FCD may also have excess mTOR signaling brain activity,     Everolimus may also reduce seizure activity in these patients.      The drug Everolimus is approved by the Food and Drug Administration to treat specific types     of breast, pancreatic, and kidney cancer, a kidney tumor called an angiomyolipoma (common in     patients with TSC), and TSC patients who have a brain tumor called a subependymal giant cell     astrocytoma (SEGA). However, in this research it is considered to be an investigational since     it is not approved for reduction in mTOR signaling and a decrease in seizure frequency.     Researchers believe that Everolimus may be useful in reducing something called cortical     hyperexcitability, which is the excess brain activity that can contribute to seizures.   "
63712|NCT02451683|"     The investigator's overall goal is to develop new strategies to enhance the recovery of     upper-limb function after spinal cord injury (SCI). The investigator proposes to use modern     electrophysiological methods to enhance the efficacy of residual corticospinal connections.     Defining the neural basis by which corticospinal volleys generate muscle responses will     provide crucial information required to maximize residual motor output. The investigator's     specific goals are to: 1) determine the temporal and spatial organization of corticospinal     volleys and motor cortical representations of upper-limb muscles after incomplete cervical     SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on     reach and grasp movements because of their importance in daily life activities.   "
63713|NCT02451670|"     This project will test the ability of an electronic medical record-based clinical decision     support system to help primary care providers identify, provide more appropriate care for,     and control Cardiovascular risk factors for patients with Serious Mental Illness.   "
63714|NCT02451657|"     The aim of this study is to assess the suitability of selected scales (floor/ceiling effects,     variability, test-retest reliability) to measure cognitive function in children with Down     syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or     language on these neurocognitive scales.   "
63715|NCT02451644|"     The study examines the association between the amount of physical activity of the patient, ie     the number of steps daily / weekly, and the pregnancy rate after embryo transfer.   "
63716|NCT02451631|"     A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control     Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System     (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus   "
63719|NCT02451592|"     The purpose of this study is to determine the risk factors for fungemia in a population of     patients diagnosed with hematologic malignancies and eligible for chemotherapy.   "
63721|NCT02451566|"     The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits     associated with using the Ovation Prime Abdominal Stent Graft System under the least invasive     conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR     protocol include: appropriate patient selection, bilateral percutaneous access, no general     anesthesia, no ICU admission post procedure, and next day discharge.   "
63722|NCT02451553|"     This phase I/Ib trial studies the side effects and best dose of afatinib dimaleate when given     together with capecitabine in treating patients with solid tumors, pancreatic cancer, or     biliary cancer that has spread to other places in the body and usually cannot be cured or     controlled with treatment and has not responded to previous treatment. Afatinib dimaleate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as capecitabine, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Giving afatinib dimaleate together with capecitabine may be a better     treatment for solid tumors, pancreatic cancer, or biliary cancer.   "
63723|NCT02451540|"     In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed     using Functional Respiratory Imaging.      In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for     Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy     and who are prone to dynamics hyperinflation will be included in this study. To indicate the     susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score     after the 6-minute walk test (6MWT) above 4.      The patients will be randomized in such a way that 1 out of 2 patients will receive placebo     and 1 the active component.      Image parameters will be assessed and the correlation with lung function and health related     quality of life will be checked before and after treatment.   "
63724|NCT02451527|"     The purpose of this study is to evaluate the pharmacokinetic study of the combination of     digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults，and to provide     scientific basis for clinical combination of PEX168 and drugs.This study is also to evaluate     the safety and tolerability of mono-digoxin or digoxin plus PEX168.   "
63725|NCT02451514|"     The purpose of this study is to evaluate persistence of bactericidal antibodies for N.     meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years     after primary vaccination in subjects who previously received a 2-dose series of     MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune     response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30     days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a     2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune     response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated     subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after     an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive     subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive     subjects and subjects who previously received one dose of MenACWY   "
63726|NCT02451501|"     To compare deposition in two different positions.   "
63727|NCT02451488|"     Randomized trial to determine if neo-adjuvant subcutaneous GM-CSF restores the host regional     lymph node immunity   "
63728|NCT02451475|"     Background: The investigator hypothesized that the combined use of pregabalin and paroxetine     would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and higher tolerability     than amitriptyline or venlafaxine.      Methods: After ethical approval, 75 patients with diagnosed fibromyalgia who were receiving     pregabalin 75 mg/day, were randomly allocated to receive amitriptyline 25 mg/day (n = 24),     venlafaxine 75 mg/day (n = 25), or paroxetine 25 mg/day (n = 26). All patients were assessed     bi-monthly for consequent six months for the changes in the SSS-8, Center for Epidemiological     Studies Depression Scale (CESDS), life satisfaction, mood, sleep quality, fatigue and     medication tolerability and adverse effects.   "
63729|NCT02451462|"     Patients who undergo bone marrow transplant for different types of cancer are exposed to many     treatments such as steroids and whole body radiation. These treatments make the transplant     possible but also make their bones weaker and more prone to fractures which can be a source     of significant disability and decreased quality of life for cancer survivors. Our trial will     investigate whether giving one dose of Zoledronic acid (a commonly used drug given to     preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone     loss caused by the transplant procedures. The investigators are also interested in studying     the complex interactions of bone, muscle and fat which are greatly affected after bone marrow     transplant.   "
63730|NCT02451449|"     The purpose of this study is to estimate the prevalence of celiac disease in a population of     men and women newly referred to fertility treatment in Danish public fertility clinics.   "
63731|NCT02451436|"     This study aims to assess the effects of a sleep and media intervention on adolescents'     overall health.   "
63744|NCT02451267|"     The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain.     The study will be double blind randomized controlled trial . 120 patients with neck pain will     be recruited for the study and divided into a research group and control group. The research     group will receive neck exercise program with neck massage and aerobic exercise (leg     bicycling with relaxed shoulders) and the control group will receive only neck exercise     program with neck massage. Both intervention will be delivered by physiotherapist over 10     treatments and will include a home exercise program. In addition, clinical prediction rule     (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment     program will be defined.   "
63824|NCT02450227|"     Absorption and metabolism of carotenoids from two types of spinach preparations will be     investigated in two study groups, short bowel/ileostomy and healthy, respectively.      The study will be conducted as a randomised, controlled, 2-way crossover study in 24     participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions with     a more and a less bio-accessible spinach preparation. The serum, chylomicron and     fecal/effluent levels of lutein and beta-carotene will be determined.   "
66114|NCT02420314|"     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care     treatment of non-small cell lung cancer (NSCLC) in adults. All subjects will receive     high-dose ascorbate in addition to the standard treatment.   "
63732|NCT02451423|"     This is a single arm, open label Phase II study of MPDL3280A, an anti-PD-L1 antibody     administered as neoadjuvant therapy to subjects with either BCG-refractory non-muscle     invasive transitional cell carcinoma (TCC) of the bladder, or muscle-invasive TCC appropriate     for cystectomy and refusing or ineligible for neoadjuvant chemotherapy. Enrolled patients     will be assigned sequentially to dose levels in cohorts of 6 patients per dose level. The     starting dose level is 1200mg x 1 dose and will be escalated in subsequent cohorts to 1200mg     q 3 weeks x 2 doses, and finally 1200mg q 3 weeks x 3 doses to determine the impact of     increasing number of treatments on the modulated immune response with the tumor tissue.     Subjects with adverse pathology (pT3/pT4 or N+) will be offered the option of adjuvant     MPDL3280A for up to 16 cumulative cycles of treatment.      After all neoadjuvant study therapy is administered, each subject will undergo cystectomy to     evaluate pathologic response to treatment and for immunologic characterization in the     resected tissue. Serum and urine will be obtained as well to characterize circulating immune     responses. After the multi-dose portion of the study has completed accrual two expansion     cohorts of up to 15 patients each with NMIBC or MIBC will be accrued at the highest dose     level for further characterization of safety, efficacy, and immunologic analysis. Patients     with pT3, pT4, or N+ disease at the time of cystectomy and no metastatic disease will be     offered the option of adjuvant MPDL3280A for up to a total of 16 cumulative cycles. All     subjects will be followed clinically for up to 2 years to assess for disease recurrence.   "
63733|NCT02451410|"     The aim of this study is to design and evaluate an educational and behavioral intervention     focused on improving nutrition and physical activity habits among preschoolers in Cuenca,     Ecuador, with the overarching goal of preventing overweight/obesity and promoting the     formation of healthy nutrition/physical activity habits.   "
63734|NCT02451397|"     A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to     which lifestyle was associated with osteoporosis among the Chinese population by using     self-reported questionnaire methods.   "
63735|NCT02451384|"     Acccording circulating tumor cells to compare the differences of different methods(routine     method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of     pancreatic body and tail.   "
63736|NCT02451371|"     The purpose of this study is to exploratively evaluate the efficacy and safety of     transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience     persistent auditory verbal hallucinations after adequate antipsychotics therapy for over     three months.   "
63737|NCT02451358|"     The aim of the study is to generate immunogenicity and safety data in the whole population to     support registration of the Quadrivalent Influenza Vaccine (QIV) in India:      Primary objective:        -  To describe in each age group the immune response induced by a single injection          (subjects aged >9 years) or 2 injections (subjects aged 6 months to 8 years) of QIV.      Secondary objective:        -  To describe in each age group the safety profile of QIV.   "
63738|NCT02451345|"     A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and     uncertainty, thereby increasing appropriate uptake of active surveillance and reducing     over-treatment of low-risk prostate cancer.      This study involves: completion of questionnaires through the secure website; consultation by     a health coach to aid men with prostate cancer in making informed treatment decision     (personalized coaching session(s)), bio-specimen collection/analysis.   "
63739|NCT02451332|"     Preventing poor perinatal outcomes is the goal of all prenatal care, yet just who will go on     to develop preeclampsia or have a growth-restricted baby is notoriously difficult to predict.     A growing body of evidence suggests inflammatory markers can help predict poor outcomes, even     prior to, and beyond, the current pregnancy. Our project will measure the response of one     robust inflammatory marker, C-reactive protein (CRP), to a safe immune provocation     recommended for all pregnant women (the seasonal influenza vaccine), and to find out whether     CRP response is associated with increased risk for gestational hypertension, preeclampsia,     preterm delivery, or birth weight. This work will help inform whether inflammatory markers     should become part of routine prenatal care.   "
63740|NCT02451319|"     To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm     diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).   "
63741|NCT02451306|"     Bipolar disorder (BPD) is often misdiagnosed as unipolar depression. This leads to inadequate     treatment and can have negative impact on the course of the disease. There is now preliminary     evidence that patients with unipolar and bipolar depression as well as healthy individuals     with a heightened risk of BPD can be distinguished from each other based on their brain     activity patterns and functional connectivity during resting state.      However, the impact of pharmacological treatment on these functional brain measures have not     yet been clarified. For common antidepressants it has been shown that they seem to normalise     aberrant brain activity patterns and functional connectivity. The problem is that some     antidepressants can induce mania or accelerate pathological cycling in depressive patients     with unrecognised BPD. Therefore, pharmacological drugs with mood-stabilising properties such     as quetiapine are more and more prescribed. Although the effectiveness and tolerability have     been proven, the neuronal effects of these adjunctive treatments are not clear. The aim of     the study is thus to investigate the impact of quetiapine on measures of brain activity in     depressive patients with a heightened risk of BPD. Moreover, the investigators want to     examine whether the investigators can distinguish depressive patients with a heightened risk     of BPD from depressive patients without a heightened risk of BPD using neuroimaging     techniques, and whether these measures can predict the course of the disease.   "
63742|NCT02451293|"     The objective of the study is to investigate whether prophylactic treatment with melatonin     has an effect on depressive symptoms. Secondarily melatonin's effect on anxiety, sleep and     circadian disturbances will be investigated.      The MEDACIS trial is a randomised, placebo-controlled, double-blinded multicenter trial     investigating the effect of 25 mg exogenous melatonin (intervention group) against placebo     (control group) and the study is designed as a parallel group superiority trial.   "
63743|NCT02451280|"     The aim of the project is to compare the effects of unilateral hybrid therapy [unilateral     robot-assisted therapy (RT)] + unilateral arm training (UAT)] and bilateral hybrid therapy     [bilateral RT + bilateral arm training (BAT)] on motor function, daily function, mobility,     life quality, and motor control strategy in stroke patients.   "
63745|NCT02451254|"     Atrial fibrillation confers up to 5-fold increased risk of stroke in the absence of valvular     heart disease. Although epidemiological studies have linked various clinical and     echocardiographic risk factors to stroke, the exact mechanism of increased risk of stroke in     AF remains poorly understood. Previous reports have suggested that loss of effective atrial     contraction because of AF is associated with thrombogenesis. Microthrombi are most likely to     form in the left atrial appendage. In contrast, intravascular thrombotic events in patients     without AF are generally associated with abnormalities of vascular endothelial function     and/or the coagulation system. On the assumption that more than 90% of all cardiac thrombi in     patients with AF form in the LA appendage, and the fact that thrombi have been identified in     15-20% of patients with AF who have clinical risk factors for ischemic stroke, it has been     deemed to be our most lethal attachment. Administration of anticoagulant therapy is     generally thought to be necessary as a preventive measure for patients at high risk of     thromboembolism, but data indicating inadequate implementation of this highly effective     therapy]. Several studies have found regional differences in platelet activation and     hypercoagulability in the LA compared with systemic circulation in patients with valvular and     nonvalvular AF, suggesting local contributing factors. Animal studies have demonstrated     increased platelet activation and endothelial dysfunction with acute AF. The ability of     antiplatelet agents to reduce the risk of cardioembolic events in AF suggests that platelets     may contribute to the pathophysiology. Platelet activation occurs with AF and rapid atrial     pacing, providing a possible mechanistic link. Other biomarkers that have proposed to improve     the prediction of thromboembolotic events in this patient population include von Willebrand     factor and D-dimer and cerebral imaging. A comprehensive understanding of the     pathophysiological sequence leading to thrombus formation in the LAA of patients with AF     could be helpful to characterize those at high risk for thromboembolic events, and     subsequently to optimize the management of high risk patients.   "
63746|NCT02451241|"     Recent evidences from small studies show potential benefit of acupuncture in the treatment of     obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on     the cardiovascular system.      Primary end-point:      To investigate the effects of acupuncture in improving OSA severity among hypertensive     patients.      Secondary end-point To investigate the effect of acupuncture in improving the quality of life     and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire     (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness   "
63747|NCT02451228|"     This study will follow pregnant women who are taking indomethacin for preterm labor to find     out the pharmacokinetics (what the body does to the drug) and pharmacodynamics (effectiveness     of the drug in treating the specific intended disease process) of this medication. This will     help us develop more information for medication dosing specific to pregnant women     experiencing preterm labor.      Indomethacin is often prescribed to pregnant women presenting with preterm labor or shortened     cervix, which places them at risk for preterm labor and delivery. Indomethacin has been used     since the 1970s to prolong pregnancy by decreasing uterine contractions. However, despite the     widespread use of indomethacin in pregnancy, there is limited information available to help     physicians determine how much indomethacin to prescribe and how often to prescribe it.   "
63748|NCT02451215|"     Laser Interstitial Thermal Therapy (LITT) is a minimally invasive surgical technique that     allows for biopsy and thermal ablation of brain tumors. Pediatric patients with brain tumors     who are eligible and enroll in the trial will undergo LITT at the time of diagnosis or at the     time of recurrence/progression rather than undergo an open craniotomy and tumor     resection/biopsy. LITT will include a stereotactic biopsy followed by thermal ablation of the     tumor. This study will monitor the safety and efficacy of LITT for the treatment of pediatric     brain tumors.   "
63749|NCT02451202|"     It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex     as an reversal in endolaryngeal surgery.      We will conduct a clinical study aiming to compare two treatment strategies; Deep     neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will     offer better stillness. We will also descriptively examine if patients would be safely     discharged from a recovery room.   "
63750|NCT02451189|"     Obesity, with its associated co-morbidities, is a major public health challenge. It is     estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is     associated with increased risk of developing diabetes, cardiovascular disease, and certain     cancers. The increasing epidemic of obesity has necessitated the study of the complex     mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are     tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of     cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several     gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been     shown to play an important role in regulating short-term food intake. Peripheral     administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man.     PYY, GLP-1 along with a host of other hormones are produced by the gut in response to     nutrient availability in different regions of the gut and provide an exquisite mechanism of     nutrient sensing in response to dietary intake. These hormones therefore represent potential     targets in the development of novel anti-obesity treatments. A novel and attractive strategy     to induce appetite regulation is the enrichment of foods with components that stimulate the     release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial     fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY     and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free     fatty acid receptors (FFAR) on colonic L cells. However, it is not known whether the three     SCFA, acetate, butyrate and propionate, differentially affect appetite and glucose control.     The aim of this study is to compare the effects of increased colonic delivery of acetate,     butyrate and propionate on appetite and glucose control in overweight men in a randomised     crossover study.   "
63751|NCT02451176|"     This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic     mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of     clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of     this study will have a major impact on the field of hernia surgery as it will provide     objective guide to mesh selection, optimize surgical approaches for complex ventral hernia     repair, and ultimately significantly improve patient outcomes.   "
63752|NCT02451163|"     The aim of the study is to measure the effect of wheat polysaccharides on the occurence of     common cold (CC) in elderly during a 12-week consumption period.   "
63753|NCT02451150|"     The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of     TAK-536 (azilsartan) in pediatric patients aged 6 to less than 16 years with hypertension.   "
63769|NCT02450942|"     This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed     tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics,     biodistribution, safety and diagnostic performance of 18F-FDS in healthy volunteers and     patients with suspected infection. A single dose of nearly 370 MBq 18F-FDS will be     intravenously injected into healthy volunteers and patients with suspected infection. Visual     and semiquantitative method will be used to assess the PET/CT images. Changes of blood     pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine     aminotransferase, albumin, and creatinine, and any adverse events will be collected from the     volunteers. Adverse events will also be observed in the patients.   "
63754|NCT02451137|"     Primary Objective:      Demonstrate clinical benefit of Toujeo in achieving individualized HEDIS HbA1c targets (<8%     if age 65 years or with defined comorbidities (as listed in Appendix G) or otherwise <7%) at     6 months without documented symptomatic (BG 70mg/dl) hypoglycemia at any time of day from     baseline to 6 months in uncontrolled insulin naive patients with type 2 diabetes initiating     basal insulin therapy in a real world setting.      Secondary Objectives:      Compare Toujeo to other commercially available basal insulins at 6 and 12 months after     initiating insulin therapy in a real world setting in terms of:        -  Patient persistence with assigned basal insulin therapy        -  Risk of hypoglycemia including the incidence and rate of documented symptomatic and          severe hypoglycemia        -  Changes in HbA1c, fasting plasma glucose, body weight        -  Differences in patient- and provider- reported outcomes (including Diabetes Treatment          Satisfaction Questionnaire Status and Change Versions DTSQs and DTSQc), Hypoglycemia          Patient Questionnaire, and patient and provider reported Global Effectiveness Scale          (GES)        -  Healthcare resource utilization including hospitalizations and emergency department or          other provider visits and healthcare costs.   "
63755|NCT02451124|"     This pilot clinical trial studies non-endoscopic brushing of the esophagus using a     non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a     condition where the lining of the esophagus has changed or been replaced with abnormal cells     that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule     balloon that brushes against the walls of the esophagus to collect esophageal samples.     Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the     esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.   "
63756|NCT02451111|"     Follicular lymphomas FL has been traditionally approached either by an initial watch and wait     policy in the asymptomatic patient, or with single agent treatments with the purpose of     maintaining a good quality of life for a prolonged time.The combination of rituximab and     ibrutinib has been tested in clinical trials and appeared to be well tolerated and active.     Since ibrutinib seems to achieve better results when administered for prolonged time as shown     in CLL, the investigators have chosen to compare its combination with rituximab to the     prolonged rituximab-only schedule that was already shown to be very active in the SAKK 35/03     trial.      The aim of the study is to investigate the efficacy, safety and tolerability of the treatment     combination of Ibrutinib and Rituximab for patients with advanced follicular lymphoma in need     of therapy.   "
63757|NCT02451098|"     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design,     Phase III Clinical Trial.   "
63758|NCT02451085|"     The purpose of the present study is to examine whether an intervention plan based on exercise     through remote rehabilitation system leads to improvement in characteristics of walking and     balance among patients after hip replacement surgery compared to the current conventional way     of exercise among these patients.   "
63759|NCT02451072|"     Aim of the present study is to investigate the neuronal correlates of self and of personal     meaning as well as the role of the serotonin (5-HT) 2A receptor system in these processes     using functional magnetic resonance imaging (fMRI) and psychometric and cognitive measures.   "
63760|NCT02451059|"     This research project is aimed to assess the effectiveness and impact of a pediatric-based     intervention aimed at reducing low-income families' unmet material needs (food, housing,     employment, childcare, household heat, education and learning the English language ) on child     health.   "
63761|NCT02451046|"     The primary objective of this study was to evaluate the ability of plasma alpha-GST     measurements in liver donor (at the time of organ removal) to predict primary dysfunction in     liver recipient. The secondary objective was to study the relationship between alpha-GST     levels in the plasma of the liver transplant recipient and early graft function recovery.   "
63762|NCT02451033|"     Cirrhosis of liver is a leading cause of morbidity and mortality worldwide . Complications     including ascites, spontaneous bacterial peritonitis (SBP), variceal bleed, hepatic     encephalopathy, hepatorenal syndrome (HRS) and development of hepatocellular carcinoma (HCC)     have poor prognosis and further decreases the survival in these patients. It has been     believed that cirrhosis is irreversible and that treatment should focus on preventing the     progression of liver fibrosis/dysfunction and its complications.      Currently the only effective treatment is liver transplantation, an increasingly limited and     expensive resource especially in developing countries. Furthermore, transplantation comes     with a requirement for lifelong immunosuppression, and considerable long-term side effects     that include chronic renal failure, post-transplant lymphoproliferative disease, and     cardiovascular complications.      Short of liver transplant, recently, reports of unexpected plasticity in adult bone marrow     have raised hopes that stem cell therapy may offer exciting therapeutic possibilities for     patients with end stage liver diseases. It has been shown that in response to acute or     chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and     differentiate into hepatic cells. Animal and human studies suggested that such cells might     contribute to the regeneration after different kinds of liver injuries . In animal models,     after liver injury, bone marrow-derived circulating pluripotent cells have been reported to     participate in liver repopulation with both non-parenchymal cells and hepatocytes. This     repopulation process, however, seems to be highly dependent on the type of liver injury and     experimental conditions. Fusion with hematopoietic cells has been substantiated as a     mechanism by which hepatocytes can regenerate, and studies have demonstrated improved liver     histology and survival in patients with cirrhosis following mobilization of bone marrow stem     cells by granulocyte-colony stimulating factor (G-CSF) . Three recent studies have     demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral     blood and their subsequent increase in liver tissue and improved survival in patients with     alcoholic hepatitis and acute on chronic liver failure (ACLF) . However there is insufficient     data on whether G-CSF improves survival and prognosis in patients with cirrhosis.      Also, Malnutrition is commonly seen (60-70%) in cirrhotics and have adverse prognosis on its     outcome . The protein catabolic state of cirrhosis is associated with severe growth hormone     (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding     protein (IGFBP)-3 . GH therapy in cirrhosis have been shown to improve nitrogen economy and     to improve the GH resistance in a small pilot study. Also, GH therapy of short duration has     shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis . GH therapy has also     shown to improve liver regeneration and protein synthesis after hepatectomy in patients of     HCC with cirrhosis . However there is scarcity of data on clinical impact of long term     administration of GH therapy in patients of cirrhosis.   "
63763|NCT02451020|"     The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at     3200 m.   "
63764|NCT02451007|"     Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the     duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the     PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in     patients with selected solid tumors.   "
63765|NCT02450994|"     Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep     related breathing disturbances in lowlanders with chronic obstructive lung disease travelling     from 700 m to 3200 m.   "
63766|NCT02450981|"     This clinical study is a phase 1 study which carried out to to evaluate the safety,     pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab     biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with     neovascular wet age-related macular degeneration.   "
63767|NCT02450968|"     Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute     mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m     to 3200 m.   "
63768|NCT02450955|"     Objective. To compare the benefits of spinal manipulation combined with massage therapy     versus massage alone in patients with tension-type headache (TTH) on the frequency, intensity     and disability caused by headache and on cervical range of motion.      Method. A factorial, randomized, double-blinded, placebo-controlled clinical trial was     conducted with a sample of 105 subjects diagnosed with TTH, divided into two groups: a) the     treatment group received a manipulative technique followed by massage of the cervical and     suboccipital region; a) the control group received massage alone. Four sessions (once per     week) were applied over four weeks. The Headache Disability Inventory (HDI) was used to     evaluate changes in the frequency and severity of headache and functional and emotional     aspects of headache. Range of upper cervical and cervical flexion and extension were     evaluated. Measures were conducted at baseline, immediately after the intervention (week 4)     and at a follow up 8 weeks after completion of the intervention.   "
63850|NCT02449889|"     This trial is investigating the efficacy and safety of highly purified human chorionic     gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of     final follicular maturation in women undergoing controlled ovarian stimulation   "
63851|NCT02449876|"     This is a pilot study to determine if neuroscience education is acceptable to adults over 65     and if it can have an impact on pain, pain beliefs and gait speed   "
63770|NCT02450929|"     This protocol is designed to determine if a transition from barrel-shaped cuff designs to the     Taperguard endotracheal tube (ETT) reduces the incidence of postoperative pneumonia in a     prospective evaluation of a large general, vascular, orthopedic, urologic and neurologic     surgical population. The protocol was originally developed as a quality assurance project to     evaluate a practice change that took place December 1, 2012. Data regarding postoperative     pneumonia and related factors will be reviewed for the 18 months prior to the practice change     and compared to data from the 14.5 months following the change. Since the results may be of     interest to a wider audience, we are converting the project to a research study that may be     published in the future.      The study will include data from all adult patients who had surgery at OHSU between June 1,     2011 and February 15, 2014. We anticipate that we will enroll approximately 40,000 subjects     (at least 22,000 in the pre-intervention group and at least 16,000 in the post-intervention     group). Data will be gathered from the OHSU electronic medical record system (Centricity and     Epic).      6. A multiple logistic regression analysis will be employed to determine the rates of     pneumonia between the use of a standard barrel-cuff designed ETT and the Taperguard ETT for     the defined group of surgical patients. The regression analysis would be adjusted for     confounding variables including ASA status, age, use of paralytic, RSI with cricoid pressure,     weight, pre-existing lung disease.   "
63771|NCT02450916|"     Objective: In addition to physical discomforts, work-related injuries and illnesses often     result in various forms of hardships, including economic hardship, labor conflicts and legal     disputes. The physical and psychological health conditions are likely to be worsen when the     social supporting systems are not well functioning. In this study, the investigators aim to     conduct in-depth interviews with injured workers to study their experiences with the social     systems, including employment protection system, workers' compensation system, health care     system and other social welfare systems, and to explore how the systems may affect workers'     physical and psychological health.      Methods: Face-to-face interviews will be conducted with a semi-structured questionnaire.     Subjects who had ever experienced work-related injuries or diseases (including muscular     skeletal disorders and work-related cardiovascular or cerebrovascular diseases) over the past     3 years are invited. The investigators anticipate to recruit a total of 60~100 cases, whom     will be recruited through the assistance of occupational physicians, occupational health     centers, labor groups and unions. Interview time will be limited to 1 hour.      Anticipated results and contribution: Findings of this study will help to advance our     knowledge concerning the functions of current social systems and the hardships of workers who     suffer from work-related injuries and diseases. Suggestions will be provided for the     improvements of current systems.      Keywords: work-related injury, occupational disease, workers' compensation, psychological,     policy.   "
63772|NCT02450903|"     This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and     safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged     stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd     will continue until the patient experiences disease progression as determined by the     investigator according to RECIST 1.1, unacceptable toxicity that precludes further treatment,     pregnancy, start of a new anticancer therapy, discontinues treatment at the discretion of the     patient or investigator, lost to follow-up, death, or study is terminated by Sponsor.   "
63773|NCT02450890|"     The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate     in children and adolescents with ADHD.   "
63774|NCT02450877|"     This study is a randomized, multicenter, open-label, Phase 2 study that will be run in 2     parts: a safety run-in part to determine the dose of azacitidine and then a second part to     determine the efficacy of that dose in children and young adults with acute myeloid leukemia     in molecular relapse after their first complete remission.      Indication Treatment of children and young adults with molecular relapse of acute myeloid     leukemia (AML) after first complete remission (CR1).      Objectives Primary Objectives Safety Run-in Part To establish a safe and tolerable dose of     azacitidine to be used in the randomized part of the study.      Randomized Part To evaluate the effect of azacitidine treatment in AML subjects at molecular     relapse after CR1 when compared to no treatment with regard to the progression-free rate     (PFR) at Day 84 (±4 days) post randomization.      Secondary Objectives Safety Run-in Part To establish azacitidine plasma pharmacokinetic (PK)     parameters in subjects with molecular relapse AML after CR1 and to assess efficacy.      Randomized Part To evaluate the safety, pharmacodynamics (PD), and efficacy of azacitidine     treatment in subjects with molecular relapse AML after CR1.      Study Design The population of this trial consists of children and young adults with AML who     achieved a complete response (CR) with molecular remission, defined as Minimal Residual     Disease (MRD) less than 5 x 10-4, following their initial induction therapy and who     subsequently have a molecular relapse (defined as increase in MRD level by at least 1 log     [10-fold] to a level greater than or equal to 5 x 10-4 despite a normal percentage [<5%] of     myeloblasts in the bone marrow [BM] aspirate and peripheral blood [PB], and in the absence of     proven histological extramedullary relapse). Eligible subjects have a documented diagnosis of     AML with at least one of the following molecular aberrations t(8;21), RUNX1-RUNX1T1, inv(16),     CBFb/MYH11, t(9;11), MLL-AF9, NPM1 mutation, or FLT3-ITD mutation. Enrolled/randomized     pediatric subjects will be followed with regular MRD testing in order to detect a molecular     relapse.      In the safety run-in part, up to 12 subjects aged 3 months to less than 18 years will be     enrolled. Six subjects will be enrolled in the first cohort of 100 mg/m2 azacitidine     administered intravenously (IV) on Days 1 to 7 of a 28-day cycle. Six additional subjects     could be enrolled into a second cohort of 75 mg/m2 azacitidine administered IV on Days 1 to 7     of a 28-day cycle depending on the safety and tolerability results of the 100 mg/m2 cohort.      In the randomized part of the study at least 68 subjects will be randomized (or more     depending on whether at least 64 subjects are evaluable for the primary endpoint), with at     least 60 of the subjects being less than 18 years of age.      Both parts of the study, the safety run-in part and the randomized part, will contain 3     periods: the screening period, the treatment period and the follow-up period. The screening     period will last no more than 10 days in the safety run-in part after which the subjects may     be enrolled and treated. In the randomized part, the screening period will last an indefinite     amount of time until detection of a molecular relapse in the PB followed by confirmation of     the relapse in both PB and BM aspirate, at which point the subject may then be randomized.     Subjects will be treated with azacitidine (safety run-in part) or in accordance to their     assigned treatment arm (randomized part). Upon discontinuation from the treatment period,     subjects will enter into the follow-up period which will last up to 2 years from last patient     enrolled/randomized.   "
63775|NCT02450864|"     Investigators recent data showed anti-inflammatory effect of Effect of Extracorporeal     Shockwave Technology (ESWT). Little studies focused on the effect and pathomechanism of ESWT     on shoulder stiffness.   "
63776|NCT02450851|"     Background:      - Without an explanation for severe and sometimes life-threatening symptoms, patients and     their families are left in a state of unknown. The NIH helped create a network of medical     research centers, called the Undiagnosed Diseases Network (UDN), to provide care and answers     for these individuals.      Objectives:      - To improve diagnosis and care for people with undiagnosed diseases.      Eligibility:      - People with undiagnosed diseases, and their relatives.      Design:        -  Participants will travel to one of the UDN medical centers for a 5-day clinical and          research visit.             -  As part of the visit, UDN healthcare providers may ask participants to have:                  -  Clinically indicated tests and procedures performed including:                       -  A physical exam                       -  Blood and urine tests                       -  A review of health and family history                       -  X-rays and body scans                       -  Surveys                       -  Photographs of the face and body                       -  A special diet to see if the body can handle the food without having a                         reaction, like vomiting                       -  Video or voice recordings                       -  Other tests and procedures to help reach a diagnosis                  -  Research tests and procedures performed including:                       -  A skin biopsy. For this, a small piece of skin will be taken.                       -  Surveys                       -  Other tests and procedures for research that may not be related to a                         diagnosis or treatment.        -  Most participants will be asked to give samples for genetic testing.        -  Participants may be contacted after their visit to discuss test results. They may also          be contacted in the future for interviews and surveys.        -  Relatives of participants may be asked to give samples for genetic testing. They may be          asked to have parts of their visit recorded and to have additional tests. They may also          be contacted in the future for interviews and surveys.        -  Clinical and research information collected will be stored in a database.        -  Information and samples collected will be shared with others for research purposes.   "
63777|NCT02450838|"     Dengue viruses are mosquito-borne flaviviruses. Each year, dengue viruses infect millions of     people throughout the tropics and subtropics. This study will evaluate the safety,     tolerability, and immunogenicity of a tetravalent recombinant subunit dengue vaccine (V180)     in healthy adults who previously received a live-attenuated tetravalent dengue vaccine (TV003     or TV005).   "
63778|NCT02450825|"     This study is designed to compare three ultrasound-based aeration scores that were previously     validated in specific populations, and to assess their correlation with computed tomographic     measurement of pulmonary aeration in a population with different pathologies.      Hypothesis: The Loss of Aeration Score will be more accurate than a simplified version and     another widely used score, the Lung Ultrasound Score.   "
63779|NCT02450812|"     This observational prospective single arm cohort study is designed to assess overall     survival, symptomatic skeletal event free survival and quality of life of of chemotherapy     naïve metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223     under real life conditions. In addition, time to next tumor treatment (TTNT), mobility,     quality of life and selfcare, independence in activities of daily living and safety will be     assessed.   "
63780|NCT02450799|"     The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL     to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take     place in Japan.   "
66154|NCT02419794|"     The aim of this study is to clarify treatment status and clinical results of acute cerebral     ischemia after approval of clot retriever in Japan, and also to obtain a basis for     comparative studies.   "
63781|NCT02450786|"     There have been growing interest in identifying Parkinson's disease (PD) patients with mild     cognitive impairment (MCI) which is susceptible to progress to PD dementia(PDD). PD-MCI is     known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels,     in which suggest the existence of something common with Alzheimer's dementia. PDD have showed     more cholinergic deficits than Alzheimer's dementia and responds to donepezil. The     investigators assume that PD-MCI patients also have cholinergic deficits. Donepezil improves     cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with     cognitive impairment. Donepezil produced similar improvements in cognition and behaviour in     DLB and PDD. This supports the hypothesis that the two disorders are closely related     clinically and neurobiologically. Larger scale, placebo controlled clinical trials are needed     to provide an evidence base to guide the clinical use of cholinesterase inhibitors in Lewy     body disease.      It is believed that earlier intervention, later appearance of dementia should be needed to     lower the socioeconomic costs and to improve the quality of life on patients and caregivers.     The investigators anticipate that donepezil may delay the development of dementia in patients     with PD-MCI.   "
63782|NCT02450773|"     The purpose of this study is to determine whether postpartum administration of furosemide to     women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or     elevated blood pressure in the first 24 hours following delivery reduces severe postpartum     hypertension.   "
63783|NCT02450760|"     The goal of this pilot project is to assess adherence with home blood pressure monitoring in     hypertensive patients with a history of cerebral infarction and to determine if a social     incentive improves adherence with monitoring. Enrolled subjects will all have a history of     cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at     the time of enrollment. To be eligible subjects will also be required to own a smart phone     (iOS or Android operating system). After enrollment, patients will be given a home blood     pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be     randomly assigned to a social incentive program, in which a social supporter receives updates     via email and/or text message on the subject's adherence with BP monitoring and their average     blood pressure. This study will provide important pilot data which will inform the design of     future studies utilizing connected health and automated systems to improve home blood     pressure monitoring and blood pressure control in patients with a history of stroke.   "
63784|NCT02450747|"     This is a four week study to evaluate the performance of a multifocal contact lens in     habitual wearers of silicone hydrogel multifocal contact lenses.   "
63785|NCT02450734|"     Since stroke and myocardial ischemia are major causes of perioperative morbidity and     mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best     hemodynamic stability are important goals of perioperative management.      The investigators conducted a prospective observational study about efficacy and safety of     the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate     postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid     endarterectomy.   "
63786|NCT02450721|"     Aim of the present study is to investigate molecular and clinical markers in patients with     atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase.   "
63787|NCT02450708|"     This study tests whether adding certain genetic factors to the process of picking a stem cell     donor can decrease the chances that the patient's leukemia will come back after bone marrow     transplantation. Stem cell donors are matched based on genes called human leukocyte     antigens (HLA).      Currently, donors are selected largely on the basis of HLA gene typing alone. There is     published data to show that donors with specific other genes called killer     immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia     return after a transplant. In this study, the best HLA matched donors will be tested for the     KIR genes. If there are more than one donor available, a recommendation will be provided to     study doctors as to which donors have potentially favorable KIR genes. The study doctors may     or may not choose to use this donor for transplant or not based on his/her own judgment.     Transplant care will not change otherwise as a result of this study.      This study is being done to demonstrate that AML patients who have donors with specific KIR     and HLA genes will have a better outcome following transplant.   "
63788|NCT02450695|"     This study will evaluate the effectiveness of rTMS as a potential treatment for refractory     OCD in a randomized, crossover design.   "
63789|NCT02450682|"     This study is being done to determine if apixaban is more safe, when compared to warfarin, at     reducing the risk of bleeding during CIED procedures.   "
63790|NCT02450669|"     Airway management in intensive care unit (ICU) patients is challenging. Benefit risk ratio of     extubation has to be daily assessed in intubated patients.      The investigators aimed to assess incidence and risk factors of airway failure after     extubation procedure in critically ill patients in a prospective multicenter study.   "
63791|NCT02450656|"     This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a     phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in     combination with selumetinib; and PART B - a randomized phase II study investigating the     progression free survival and safety of selumetinib/afatinib combination therapy compared to     standard of care chemotherapy.   "
63792|NCT02450643|"     Infants/children with cow's milk allergy will take part in 2 double-blinded     placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random     order. If both food challenges are passed, subjects will be asked to consume the Test formula     in an at-home open challenge for 7 days.   "
63823|NCT02450240|"     In this study the investigators will seek to improve our understanding of how positive and     negative valence systems, cognition, and arousal/interoception are inter-related in disorders     of mood, substance use, and eating behavior. The investigators will recruit 1000 individuals     and use a wide range of assessment tools, neuroimaging measures, blood and microbiome     collections and behavioral tasks to complete the baseline and follow-up study visits. Upon     completion, the investigators aim to have robust and reliable dimensional measures that     quantify these systems and a set of assessments that should be recommended as a clinical tool     to enhance outcome prediction for the clinician and assist in determining who will likely     benefit from what type of intervention.   "
63793|NCT02450630|"     Uganda's under-five mortality is high, currently estimated at 90/1000 live births (Uganda     Bureau of Statistics 2011). Poor referral of sick children that seek care from the private     sector is one of the contributory factors. The proposed intervention aims to improve uptake     of referral advice for children that seek care from private facilities (registered drug     shops/private clinics).      The project will be implemented in Mukono district, central Uganda selected because a recent     concluded trial in the district showed that drug shop vendors (DSVs) adhere to diagnostic     test results, treat appropriately and refer sick children; although uptake of referral is     poor. The main reasons attributed to the observed poor referral were negative attitude     towards referral forms from drugs shops by the health workers at referral     facilities,perceptions of poor quality of care at referral facilities and costs involved     (Hutchinson. 2012; Hutchinson et al. 2013 in press)..      Thus the proposed project is a follow up to address these factors with the aim to improve     uptake of referral. This project is in line with the Uganda's Health sector and USAID     Mission's health priorities of strengthening the health system. Critical barriers in the     implementation of child survival interventions are poor quality of care in the private sector     and timely referral and uptake of referral advice at community level. These barriers may be     attributed to inadequate training of providers in the private sector (in diagnosis and     management of childhood illnesses); inadequate supervision and regulation; poor linkages and     collaboration between the public and private sectors; and non-existent linkages between     community structures and the private sector. The barriers will be addressed through an     intervention with three components; i) VHTs will be trained to do community sensitization and     initiate community discussions aimed at identifying community support mechanisms for     financial hardship (to be community led and managed) - e.g. communities to be encouraged to     establish community credit/insurance schemes for referral VHTs will register children and     facilitate follow up of sick children ii) supervision of providers in the private sector to     diagnose, treat and refer sick children, iii) regular meetings between the public and private     providers (convened by the district health team) to discuss the referral system.   "
63794|NCT02450617|"     The research project outlined in this proposal aims to investigate the effectiveness of     stabilizing group treatment as an add-on to conventional treatment, for patients with Post     Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The     investigators also aim to study psychophysiological markers associated with complex trauma     and treatment, mechanisms of change involved in treatment, and which patient characteristics     that predict positive outcome.   "
63795|NCT02450604|"     Fabry disease is a rare inherited metabolic disorder that predominantly affects heart,     kidneys and nervous system. Fabry disease has been searched in series of patients presenting     different isolated signs caused by the affection of one of these organs. Acroparesthesias and     chronic crises of pain of different origins are reported in the large majority of patients     during the progression of the disease. Moreover, this signs are frequently inaugurating the     disease. The investigators have previously performed a preliminary single-center study which     permitted to identify one female patient with Fabry disease in a series of 147 consecutive     patients with chronic pain tested. The investigators now propose to confirm the results of     our preliminary study. The investigators plan to evaluate the prevalence of Fabry disease in     a series of 1000 patients suffering from chronic pains of undetermined aetiology and     consecutively recruited.   "
63796|NCT02450591|"     This study will test if local therapies in addition to erlotinib can improve responses and     delay the time until new treatment is required. This study will also collect blood samples     for research blood tests.   "
63797|NCT02450578|"     Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and     validated Human Challenge model using direct venous inoculation of aseptic, purified,     cryopreserved, vialed Plasmodium falciparum sporozoites.   "
63798|NCT02450565|"     Neuropathic pain, described as 'pain arising as a direct consequence of a lesion or disease     on the somatosensory system', affects up to 3-9.8% of the investigators' population, but is     often underdiagnosed and undertreated. As treatment is different for patients with     neuropathic pain and nociceptive pain, it is important to screen for neuropathic pain.     Commonly employed questionnaire-based diagnostic tools in English speaking countries include     the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and Neuropathic     pain questionnaire (NPQ). Self-completed LANSS is particularly useful as it is not restricted     to clinician's examination and can be applied in large-scale research. S-LANSS has been     successfully translated, validated and used successfully in Arabic and Turkish, but it has     not been utilised in the Chinese population. As verbal translations of the English     questionnaires used at the bedside may be prone to errors in interpretation and requires     medical practitioners to interpret the questions. Therefore a translation and validation     study is essential.   "
63799|NCT02450552|"     This study evaluates the effect of retigabine (600 mg/day, 900 mg/day, or placebo) on motor     neuron activity in people with Amyotrophic Lateral Sclerosis (ALS). The total study duration     is approximately 14 weeks. ALS subjects will take study drug for approximately 10 weeks.   "
63800|NCT02450539|"     The main purpose of this study is to evaluate the effectiveness of the study drug known as     abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung     cancer (NSCLC) previously treated with platinum-based chemotherapy.   "
63801|NCT02450526|"     The objective of this study is to demonstrate the efficacy of Dysport for the improvement in     appearance of moderate to severe glabellar lines and to assess the short term and long term     safety of Dysport, used for the improvement in appearance of moderate to severe glabellar     lines in Chinese subjects.   "
63802|NCT02450513|"     Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's     disease who are naïve to TNF antagonist therapy.   "
63803|NCT02450500|"     More than a third of the adult population in England have prediabetes, a condition that     occurs when glucose levels are higher than normal but not high enough to be diagnosed as     diabetes. Between 5 and 10% of people with prediabetes will go on to develop diabetes each     year. Lifestyle (diet and activity) interventions have been shown to reduce the risk of     prediabetes progressing to Type 2 diabetes. However, in practice high levels of professional     support coupled with increasing incidence of prediabetes are not sustainable in their current     format. The internet has the potential to provide an alternative means of supporting large     numbers of individuals in making lifestyle changes. However, provision of information on its     own is not enough to engage individuals to change - additional support via personalised     feedback is required to sustain the level of motivation needed for long term behaviour     change.      AIM: The investigators hypothesis is that communicating with individuals at high risk of Type     2 diabetes via a web-based lifestyle app will lead to changes in lifestyle behaviours     resulting in an improved glycaemic control and reduction in diabetes risk.      METHOD: The study will be conducted over 6 months. Patients identified in GP practice who are     at high risk of developing diabetes will be invited to take part in this feasibility study.      Intervention (6 months): This will consist of a web-based lifestyle app and personalised     behaviour modification advice delivered via messaging by a dietitian. Participants will also     be issued with a pedometer. Data on the dietary intake and activity levels will be collected     on the web-based lifestyle app. Contact between the dietitian and participants will consist     of weekly messaging to facilitate changes in diet and activity behaviour through motivational     and cognitive behavioural strategies.      Blood biochemistry (HbA1c, FBG, LFT's and lipids), BP, weight, BMI, and waist circumference     will be measured at 0, 3 and 6 months. The blood test will be taken by a practice nurse at     the GP practices and sent off for analysis. A 5 day food diary, well-being and activity     questionnaires will be collected at 0, 3 and 6 months by the researcher.      At the end of the intervention period, participants will be invited to attend a focus group     to assess participants' perceptions/ease of use and barriers to use of the technology     employed to assist behaviour change   "
63804|NCT02450487|"     Pharmacogenetics is an area of Pharmacology that studies the contribution of genetic factors     to individual responses to drugs. This branch of science involves the variability in     pharmacodynamics and pharmacokinetics through the study of polymorphisms in genes encoding     receptors, as well as in drug metabolism, where this area of Pharmacology has been growing     and achieving its first results with clinical use. The non-steroidal anti-inflammatory     (NSAIDS) are metabolized by cytochrome P450 (CYP) family, predominantly CYP2C9. The goal of     this study is to evaluate the different gene haplotypes for the clinical efficacy of     piroxicam after third lower molar surgery for pain, edema and trismus, adverse reactions,     need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics     of the drug between the different gene haplotypes for CYP2C9 that are found in this     population. Therefore, 60 patients will be genotyped and phenotyped for this gene and their     postoperative data will be confronted with the data found in the Brazilian population. For     the analysis of the proposed gene, saliva will be collected and serve as a source of genomic     DNA. For the molecular analysis, polymerase chain reaction (PCR) with tests validated and     produced by Applied Biosystems® will be performed. For the pharmacokinetics, saliva samples     will be collected at various times according to protocols available in the literature, and     piroxicam concentrations in the samples will be measured by high pressure liquid     chromatography (HPLC) and Liquid chromatography-mass spectrometry (LC MS/MS). The analysis of     the results will be described with a significance level of 0.05.   "
63805|NCT02450474|"     Cardiovascular disease is the leading cause of death of dialysis patients and poor fluid     management is associated with the increased risk. One of the principal limitations in     avoiding chronic fluid overload in this patient group is the refilling rate the rate at which     fluid is transferred from tissues into the vascular system. If this rate cannot match the     prescribed rate of fluid removal during dialysis the patient will end up with chronic fluid     overload.      Two proposed methods of increasing the rate of refilling are intermittent pneumatic     compression (IPC) devices, which increase the pressure of the fluid in tissue, and     neuromuscular electrical stimulation (NMES) which activates the muscle pump and lymphatic     drainage.      This investigation will trial the use of these two methods in patients suspected of having     inadequate refilling rates. Outcome measures will be based on fluid status, presence of     oedema and quality of life.   "
63806|NCT02450461|"     The purpose of this study is to answer the question whether a disease-specific profile of     breath in patients with asthma can be detected by an untargeted metabolomic study using     exhaled breath analysis by mass spectrometry.   "
63807|NCT02450448|"     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in     renal cancer could play an important role in diagnosis, predicting the risk for tumor     recurrence, and providing novel target therapy biomarkers. In view of these facts, the     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting     human tumor cells of renal cancer in normal peripheral blood after cryosurgery with or     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)     method.   "
63808|NCT02450435|"     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in     prostatic cancer could play an important role in diagnosis, predicting the risk for tumor     recurrence, and providing novel target therapy biomarkers. In view of these facts, the     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting     human tumor cells of prostatic cancer in normal peripheral blood after cryosurgery with or     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)     method.   "
63809|NCT02450422|"     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in     colorectal cancer could play an important role in diagnosis, predicting the risk for tumor     recurrence, and providing novel target therapy biomarkers. In view of these facts, the     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting     human tumor cells of colorectal cancer in normal peripheral blood after cryosurgery with or     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)     method.   "
63810|NCT02450409|"     Beside the current standard of classical mechanical alignment of total knee replacements,     increased interest is being shown in anatomical alignment. However, no surgical technique is     capable of controlling the stability of the joint in midflexion. The purpose of the present     study was to present and evaluate a new surgical technique, which aims to reduce the need for     soft-tissue release and optimize stability in midflexion.   "
63811|NCT02450396|"     Rare diseases frequently affect women of childbearing age. Pregnancy in these women has     become less rare, but remains associated with high levels of complications. One obstacle to     their optimal management during pregnancy is that there are no prospective studies of     pregnancy during rare diseases and several connective tissue diseases. As a consequence, the     management of these pregnancies is non-standardised in terms of treatment, monitoring     (frequency of consultations, laboratory tests and ultrasound), and organisation of care.      Moreover, although these women (all diseases combined) are frequently exposed to medications     potentially incompatible with pregnancy, little is known about the frequency of these     exposures and especially their consequences to mother and child.      For these reasons, researchers and clinicians from different specialties created an     interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve     the management of these patients' pregnancies. Using a single computer server, the     investigators plan to set up a large prospective study of pregnancies in patients with rare     diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome,     scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse     the complications of pregnancies in women with rare diseases and then to improve their     management and their quality of life.   "
66155|NCT02419781|"     The aim of this study is to clarify the efficacy of the endovascular treatment for acute     ischemic stroke patients with large vessel occlusion and are not respond to intravenous     recombinant tissue plasminogen activator (rt-PA) therapy.   "
63812|NCT02450383|"     The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular     dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an     autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults.      AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for     transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements     for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of     the American Association of Tissue Banks (AATB).      20 adult subjects will be recruited who are in need of dental implant placement with     simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the     subjects will be randomized to the ADM group and half will be randomized to the sCTG group.     The surgical intervention will be performed according to the protocol and subjects will     return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of     healing, gum thickness, subject perception of pain, and esthetic photographs.   "
63813|NCT02450370|"     Subjects with confirmed diagnosis of Irritable Bowel Syndrome will be blinded and randomly     assigned to one of two groups, the low FODMAP diet or the conventional IBS diet group. They     will be referred to do three hydrogen breath tests prior to diet education. Upon completion,     subjects will attend dietitian consultations at Week 0, 6 and 10 for diet assessment,     education and reinforcement. At Week 4 and 8, dietitians will telephone patients to check on     diet compliance and answer any diet question. Two sets of questionnaires, the IBS Global     Improvement Scale and the IBSQOL will be given to patients to complete before each dietitian     visit at week 0, 6 and 10. Two sample t-test and Chi square test will be used to test the     difference between the two groups and the association between breath tests results and     responds to the two diets.   "
63814|NCT02450357|"     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in     breast cancer could play an important role in diagnosis, predicting the risk for tumor     recurrence, and providing novel target therapy biomarkers. In view of these facts, the     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting     human tumor cells of breast cancer in normal peripheral blood after cryosurgery with or     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)     method.   "
63815|NCT02450344|"     Objectives The aims of this study are to test the effectiveness of an online quiz competition     in changing adolescents' alcohol-related attitudes and behaviour and to explore the     fe¬asibility of using Internet viral marketing to reach a significant number of adolescents.      Hypotheses to be tested        1. The present online quiz competition is more effective in changing adolescents'          alcohol-related attitudes and behaviours than traditional health promotion.        2. Internet viral marketing is effective in reaching a significant number of adolescents.      Design and subjects The study will constitute a cluster randomised controlled trial for 20     secondary schools (6,720 Grade 7 to 9 students). Schools will be randomised to intervention     or control arm with equal likelihood. Students in intervention schools will be invited to     take part in the Internet campaign whereas those in control schools will receive relevant     promotional leaflets.      Study instrument An alcohol attitude and behaviour survey will be compiled with reference to     standardised, validated instruments.      Intervention Participants will log into the website and answer alcohol-related     multiple-choice questions. They will be encouraged to promulgate the campaign to others.      Main outcome measures Alcohol-related attitude and behaviour will be the primary outcome     measures.      Data analysis Multilevel regressions will mainly be used to evaluate the difference in     attitude and behaviour.      Expected results The results of the proposed study will provide evidence on the efficacy of     an Internet intervention in modifying adolescents' attitudes and behaviour and guide further     investigation into the prevention of and intervention in such risk behaviours as underage     drinking.   "
63816|NCT02450331|"     This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and     safety of adjuvant treatment with atezolizumab compared with observation in participants with     muscle-invasive urothelial carcinoma (UC) who are at high risk for recurrence following     resection. Eligible participants will be randomized by a 1:1 ratio into atezolizumab group or     control group.   "
63817|NCT02450318|"     The purpose of this study is to examine the acute effect of exercise on vascular function in     women with nonobstructive coronary artery disease.   "
63818|NCT02450305|"     The investigators intend to determine if patients that are already undergoing Hyperbaric     Oxygen (HBO) therapy one year post treatment with radiation therapy for head and neck cancer,     experience improvement in xerostomia and/or taste alteration. The investigators will enroll a     similar demographic one year post treatment with radiation therapy that does not receive HBO     therapy. This is a quality of life study.   "
63819|NCT02450292|"     The purpose of this study is to examine the long-term appearance and resorption rate of     biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).   "
63820|NCT02450279|"     Many devices are available for nebulising drug solution during invasive mechanical     ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent     international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013)     reported that jet nebulizers remained the mostly used.      The aim of this study is to compare lung deposition of a radiolabeled administered with both     nebulizers during invasive mechanical ventilation by planar scintigraphy.   "
63821|NCT02450266|"     Patients will be submitted to a multiparametric MRI examination of the prostate.     Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A     patients will be submitted to the gold-standard which comprises systematic transrectal     ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted     prostate biopsy based on the multiparametric MRI findings.   "
63822|NCT02450253|"     Could Tadalafil improve blood flow in deep brain tissue and potentially improve cognitive     function in patients with cerebral small vessel disease   "
63852|NCT02449863|"     Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung     ultrasound is a useful diagnostic tool that is quick, requires little training and is     radiation free. This study analyzes whether early lung ultrasound can predict respiratory     failure.   "
63825|NCT02450214|"     Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The     management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs)     are insufficient, while opioids are avoided by their adverse effects and regional techniques     are hampered by a premature discharge. In this context, the investigators seek an     intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus     magnesium to significantly decrease postoperative pain.   "
63826|NCT02450201|"     This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the     acquisition of magnetic resonance (MR) data and will be performed in men with localized     prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR     imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five     patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of     ADT.      13C HP MR data will be acquired in two parts of the study (which can occur simultaneously):     Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks     later (with no intervention in the interim) to evaluate reproducibility.      Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and     undergo repeat imaging two months after initiation of ADT to evaluate the ability of the     imaging to reflect a metabolic response to treatment.      The change in pyruvate/lactate ratio and lactate levels will be measured and compared to     baseline at these timepoints.   "
63827|NCT02450188|"     The aim of the present study is to evaluate the efficacy of a combined approach with     Vardenafil orodispersible and Cognitive Behavioural Sex Therapy in the treatment of Erectile     Dysfunction, compared to medical only treatment, in terms of quality and duration of erection     and couple's sexual satisfaction.   "
63828|NCT02450175|"     The purpose of this research study is to understand if platelets in the blood become more     active during cancer and specially advanced stages of cancer, in the future the investigators     want to see if reducing platelet activity can improve survival in advanced cancer.   "
63829|NCT02450162|"     -  Background and study aims : The investigators conducted this study to compare the          movement of extraocular muscle after two types of recession surgery with non-invasive          tool called AS-OCT.        -  Who can participate? patients who will undergo two types (conventional method and          hang-back method) of typical bilateral lateral rectus recession surgery for correcting          intermittent exotropia        -  What does the study involve? Volunteers will attend a clinic for four visits over three          months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is          non-invasive test to evaluate operation site. The test only requires their cooperation          when they undergo AS-OCT.        -  What are the possible benefits and risks of participating? This is non-invasive test for          your postoperative follow up. Therefore, there will be no risks about this test.        -  Where is the study run from? Samsung Medical Center        -  When is the study starting and how long is it expected to run for? From April 2015 to          Dec 2015   "
63830|NCT02450149|"     This is a pilot study of sorafenib in patients with BRAF Mutation Refractory Solid Tumors.      This study is a single-arm, pilot study of sorafenib in patients with Refractory Solid Tumors     harboring BRAF Mutation Sorafenib 400 mg will be administered orally twice a day for 28 days.      To investigate the efficacy of sorafenib in patients with Refractory Solid Tumors harboring     BRAF Mutation.   "
63831|NCT02450136|"     This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation     Refractory solid tumors.      This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors     harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally     once a day 28 days.Study treatment will be continued until objective disease progression.      To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring     FGFR2 Amplification or FGFR2 mutation.   "
63832|NCT02450123|"     This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2     Amplification Refractory solid tumors.      This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors     harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered     orally once a day 42 days.Study treatment will be continued until objective disease     progression.      To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring     RET fusion positive or FGFR2 Amplification.   "
63833|NCT02450110|"     A randomized pilot study of spinal cord stimulation in patients with chronic heart failure     aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.   "
63834|NCT02450097|"     The aim of the present study is to investigate in subjects with and without type 2 diabetes     the effect of calorie restriction (CR) according to the 5:2 method for 6 months (every week     two days caloric fasting with 500 calories for women and 600 calories for men and five days     of normal caloric intake) on risk markers for cardiovascular disease and certain cancers     (hyperinsulinemia, insulin resistance, IGF-1, IGFBP-1, IGFBP-2, glucose, HbA1c, blood lipids,     markers of inflammation and oxidative stress) and on peptides regulating glucose metabolism     and appetite as well as the effect on blood pressure, body composition, waist- and hip-     circumference. DNA will also be analysed at the start and after 6 months to investigate any     epigenetic effects.      After completed study there will be a follow up after additional 6 months.   "
63835|NCT02450084|"     Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative     analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is     accompanied by significant postoperative pain and usually IV-PCA is used to manage the     pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided     RSB to single-port robotic gynecologic surgery which has incision site at umbilical area.     Patients will randomly assigned to two groups, RSB group and Control group. Each patients     will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number     of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded     investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.   "
63891|NCT02449356|"     In this study, the investigators adopt the special endotracheal tube to those patients at     prone posture during the operation,or those with acute respiratory distress syndrome in the     intensive care unit(ICU), so that the investigators can reduce, or even avoid some severe     complications during perianesthesia, and that the investigators can provide strong safeguard     measures for the respiratory therapy of critical patients in ICU.   "
63836|NCT02450071|"     Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A     recent Danish multicentre single country study demonstrated a 99,7% incidence of successful     anaesthesiologist pre-hospital endotracheal intubation, with a PHAAM-related complication     rate of 7.9%. A London study revealed a significantly higher intubation failure rate among     non-anaesthesiologist physicians. In Scandinavia different types of emergency medical     services (EMS) and professions provide PHAAM. The success rate of prehospital endotracheal     intubation (PHETI), incidence of difficult intubation and complications in the Nordic     countries is not known. The aim of this study is to define PHAAM success rate and     complications in different types of Nordic EMS organisations and physician critical care     teams. The study is a prospective observational study with collection of PHAAM data according     to the template by Sollid et al. in the 12 participating Nordic Countries EMS/HEMS centres     and physician critical care teams. The primary endpoint is PHETI success on ≤2 attempts and     no complications.   "
63837|NCT02450058|"     In this multicenter, randomized phase III trial, node positive early breast cancer patients     are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin     60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP     (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary     study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free     survival (EFS).   "
63838|NCT02450045|"     Hip fractures (broken hips) are common in older people, particularly older women with fragile     bones, and usually occur with a simple fall from a standing height. In Canada, over 28,000     hip fractures occur every year, and approximately 900 occur in Edmonton. After a hip     fracture, up to 50% of those who survive their hip fracture do not recover to the same level     of activity that they had before breaking their hip. Managing pain with any broken bone is     very important. For patients with hip fracture, their older age and fragile health makes pain     management even more challenging. Many patients with a hip fracture have reduced ability to     think clearly before the fracture. Some patients who have no difficulty with thinking before     their hip fracture will become confused for a brief period after their hip fracture or can     develop permanent difficulties with thinking. A hip fracture will usually require an     operation, and choosing the right pain medication before and after the operation is important     since many pain medications make confusion more likely. Permanent difficulty with thinking is     a common reason for poor recovery after hip fracture. Our study will look at use of a nerve     block to manage pain before patients have their operation. A nerve block provides local pain     relief without requiring patients to take the medication by mouth (oral) or through an     intravenous (IV) route. A nerve block before surgery may reduce the amount of oral and IV     pain medication needed by the patient both before and after their operation but still provide     good pain control with less confusion. This could lead to better recovery and allow more     patients to return to living in the community rather than long-term care.   "
63839|NCT02450032|"     This study was designed to investigate the antibody response generated by a 500µg dose of     G17DT in patients with gastric cancer.   "
63840|NCT02450019|"     The purpose of this study is to assess the effect size and variability of dural tension     measured as intracranial pressure (ICP) below the dura of the surgical field in patients     undergoing elective supra-tentorial surgery for brain neoplasms in patients alternatively     ventilated with traditional high-volume-no-PEEP ventilation and protective     low-volume-low-PEEP ventilation.   "
63841|NCT02450006|"     To collect biological samples, clinical information and laboratory data from patients     diagnosed with any healthcare-related conditions who are seen at facilities affiliated with     Intermountain Healthcare, including patients and their family members, and to collect the     same information and samples from a general population including disease-free subjects.   "
63842|NCT02449993|"     This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of     breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for     expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with     MammaTyper™.      According to the determined values for the individual parameters at least 4 subtypes can be     distinguished to date        -  Luminal A-type        -  Luminal B-type        -  HER2-type        -  Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with          Immunohistochemical methods will be evaluated.      As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall     survival (OS) will be reevaluated according to the new subtyping.   "
63843|NCT02449980|"     The purpose of this study is to compare the outcomes between delayed surgery and immediate     surgery in children who have spontaneous pneumothorax (collapse of the lung). Currently, both     methods to treat spontaneous pneumothorax has been used but there is no clear evidence that     one option is better, which is the reason for the investigators current study. The     investigators hypothesize that immediate surgery will have better outcomes with lower     recurrence rates than delayed surgery.   "
63844|NCT02449967|"     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional     therapy using digital subtraction Angiography（DSA）for pancreatic cancer.   "
63845|NCT02449954|"     Comparison between the effects of intravenous morphine, tramadol and ketorolac on stress and     immune responses in patients undergoing modified radical mastectomy   "
63846|NCT02449941|"     The purpose of this study is to know the distribution of HP in stomach before use of PPI,     during use of PPI, and after stop of PPI.   "
63847|NCT02449928|"     Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with     other solution, in order to make clear whether can improve the prognosis.   "
63848|NCT02449915|"     To determine if the injection of liposomal bupivacaine to laparoscopic port sites and     rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant     rectocele repair will result in decreased postoperative pain compared to injection of     placebo.   "
63849|NCT02449902|"     The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating     moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of     treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints.     In addition, the systemic exposure to estradiol from single and multiple doses of     TX-12-004-HR was to be investigated.   "
63892|NCT02449343|"     Compare the effects and safety of Anlotinib with placebo in patients with soft tissue     sarcoma.   "
63853|NCT02449850|"     The primary objective is of the PreventADALL study is to test if primary prevention of     allergic diseases is possible by simple and low cost strategies, and secondary to asses the     impact of xenobiotic exposure and microbiota in and on the body and the environment on     allergic disease development.      The secondary objective is to investigate early life risk factors for development of asthma     and allergic diseases as well as for diseases that may share common risk factors, including     cardiovascular disease, obesity and diabetes.      Design: A multi-national population-based prospective birth cohort with a factorial designed     randomized controlled intervention trial of two clinical interventions; skin care 0-9 months     and early food introduction by 3-4 months, thereafter observation only.      Recruitment in three cities (Oslo, Østfold and Stockholm) of approximately 2500 babies is     done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound     investigation (n=approximately 2700) and thereafter their new-born babies are included.      Randomisation into four groups is done by the postal code or bydeler to ensure all four     intervention-groups within each bydel.      Visits for biological and environmental sampling, observations and investigations will be at     the relevant paediatric departments (at 3-6-12-24 months of age) and annually thereafter. It     is a hope that the study can be maintained well into adulthood.   "
63854|NCT02449837|"     The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in     cancer patients before and after undergoing treatment regimens where the primary treatment     modality is radiation therapy (XRT). Specifically, there is interest in the change in CTCs     pre- and post- XRT, both in absolute and relative terms.   "
63855|NCT02449824|"     Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a     standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in     those patients who go on to respond to treatment. Importantly, the investigators will also     show that blood flow does not decrease in those patients who fail to respond.      Secondly, the investigators will test whether the decrease in tumour blood flow over the     whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at     the time of surgery.   "
63856|NCT02449811|"     Randomized, open-label, parallel-group study conducted at a single center in Switzerland.      Patients diagnosed with primary arterial hypertension requiring antihypertensive drug     Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be     recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to     either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium     channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current     guidelines issued by the European Society of Hypertension. Treatment-naive patients will be     started on an intermediate dose monotherapy (treatment period 1). In all patients who do not     reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled     (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles,     measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will     be done. A control group with 20 age and gender matched, healthy and normotensive subjects     will be recruited to establish the characteristics of the RAS peptide profiles in a     comparable but normotensive population.   "
63857|NCT02449798|"     Study objective is to evaluate user preference, time for procedure, insertion success rates,     complications, completion of therapy and dwell time of the AccuCath 2.25 BC device placed in     difficult IV access patients in the emergency department.   "
63858|NCT02449785|"     Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic     fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung     morphological changes in cystic fibrosis adults but it remains a radiation-based technique.     MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative     for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung     involvement using CT and MRI-UTE, and to test the agreement between both techniques.   "
63859|NCT02449772|"     Retrospective study of adult patients (> 16 y) admitted to Geneva University Hospitals with     alcohol abuse. Triage criteria will be reviewed. Patients characteristics and patient flow in     the ED will be described.   "
63860|NCT02449759|"     This study aims to evaluate the effectiveness of a guided self-help intervention using     Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help     manual whilst on a waiting list for individual therapy, while the other half will remain on a     waiting list and not receive the manual. This study is looking specifically at individuals     with mild to moderate anxiety and/or depression.   "
63861|NCT02449746|"     Psychosis is a mental health problem that causes people to perceive or interpret things     differently from those around them, often involving hallucinations or delusions. Psychosis     and schizophrenia are common disorders which predominantly affect younger adults. Recently,     the investigators discovered that 5-10% of people with psychosis have antibodies in the blood     that are capable of targeting the surface of brain cells, specific to the     N-methyl-D-aspartate (NMDA) receptor or voltage gated potassium channel complex, which the     investigators believe may be causing the problem. Those positive for antibodies may have a     problem with their immune system and this may prevent their brain from working normally. This     trial aims to test the feasibility of removing or reducing the antibodies in patients' blood,     using immunotherapy, and see if this improves symptoms of psychosis. Immunotherapy in this     feasibility study will involve giving all patients steroid tablets and half of them will also     receive a drug called intravenous immunoglobulin whereas the other half will have a     procedure called plasma exchange. The feasibility study is designed to identify which     method of immunotherapy is most suitable for use in this patient population.      Results from this will inform on the methodology used for a proposed larger randomised     control trial.   "
63862|NCT02449733|"     The purpose of this study is to evaluate the acceptability and uptake of a combination     package of biomedical, behavioral and community-level HIV prevention interventions and     services for men who have sex with men (MSM) in South Africa.   "
63863|NCT02449720|"     This study will evaluate the addition of a local anaesthetic infusion into the abdomen to     patient controlled analgesia in the management of postoperative pain and recovery after bowel     surgery. Half of the patients will have an infusion of a local anaesthetic called ropivacaine     and half will have an infusion of placebo in addition to their normal pain relief.   "
63864|NCT02449707|"     Ultrasound activated pins have been used for the promotion of bone healing in combination     with biodegradable membranes during bone grafting procedures. In the jaws, these pins have     been successfully tested for both maxillary and mandibular ridge augmentaton. However, the     usefulness of these pins in maxillary sinus lift procedures has not been tested. This study     aims to use a bilateral split mouth design to compare the bone formation, healing and     post-operative complications after the use of ultrasonic guided pins in a lateral window     maxillary sinus augmentation procedure in comparison to lateral window maxillary sinus     augmentation procedure procedure performed without the use of these pins.   "
63865|NCT02449694|"     A prospective, single-center controlled trial to evaluate the safety and performance of the     portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for     transplantation.   "
63866|NCT02449681|"     This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib),     a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell     carcinoma of the head and neck or skin.   "
63867|NCT02449668|"     The main objective of the current study was to assess the analgesic effect achieved to short-     and medium-term by the use of acupuncture on individuals with impingement syndrome of the     shoulder, in comparison to the use of acupuncture at sham points. Furthermore, secondary     objectives were also sought, such as the short- to medium-term functional recovery of the     affected joint, knowing the possible influence that this has over the recovery of the     laterality of the subject, as well as the development of a protocol to select points to treat     pain affecting the shoulder area.   "
63868|NCT02449655|"     Phase II trial of AZD5363 plus paclitaxel / AZD2014 plus paclitaxel in biomarker negative     (PIK3CA/MEK/RAS/TP53/MET) advanced gastric adenocarcinoma patients as second-line     chemotherapy.      Each arm is composed of 25 patients.      AZD5363 400mg bid 4 days on/ 3 days off of a 7 day cycle for each week that paclitaxel is     given + paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle. AZD5363 and paclitaxel     will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week     cycles.If paclitaxel therapy is stopped then AZD5363 can be given on a 4on/3off continuous     schedule.      AZD2014 50mg BD 3 days on 4 days off of a 7 day cycle + paclitaxel 80mg/m2 given days 1, 8     and 15 of a 28 day cycle.      Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted at     screening (within 28 days prior to first dose) and every 8 weeks relative to the date of     first dose, up to week 40, then every 16 weeks until objective disease progression (within a     window of +/- 7 days of the scheduled date).      Study treatment will be continued until objective disease progression.      The purpose of this study is to investigate the safety and efficacy of AZD5363 plus     paclitaxel in biomarker negative (PIK3CA/MEK/RAS/TP53/MET) advanced gastric adenocarcinoma     patients as second-line chemotherapy.   "
63869|NCT02449642|"     Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered     by GnRH agonist for final oocyte maturation.   "
63870|NCT02449629|"     This study uses a transformative multiphasic mixed-methods research design that incorporates     elements of the following designs:        -  Sequential: a secondary data analysis was conducted, using data from ATN 039, ATN 086,          and ATN 106, to influence the development of the qualitative interview and quantitative          survey instruments for primary data collection.        -  Convergent parallel: concurrent collection and analysis of both qualitative and          quantitative primary data that will be combined to address the study objectives.   "
63871|NCT02449616|"     The purpose of this study is to evaluate the safety of repeat administration of MST-188     during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate     the development of acute chest syndrome during VOC and re-hospitalization for recurrence of     VOC.   "
63872|NCT02449603|"     This is a multi-centre, open-label, randomized, parallel trial to compare the effect of     Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers     in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin     monotherapy.   "
63873|NCT02449590|"     AIMS:      The aims are to investigate whether:        -  Increased intake of onion (powder) affects plasma lipid profile, blood pressure, indices          of insulin sensitivity and blood coagulation.        -  Increased intake of onion (powder) affects the expression/activity of enzymes in the          defence against foreign substances, e.g. reactive oxygen species, and whether          polymorphisms in some of the involved genes may modulate the effect.        -  Polymorphisms involved in the metabolism/effect of bioactive components in onion          modulate the excretion of metabolites or modulate some of the outcome variables in the          study.      Other aims are to try to identify biomarkers for onion consumption in plasma, urine and feces     and to investigate whether onion affects the secretion of fat and bile acids.      HYPOTHESES:      The investigators hypothesize that:        -  2 weeks of increased onion intake will improve the plasma lipid profile        -  2 weeks of increased onion intake will increase the metabolism of potentially harmful          substances (such as ROS and free radicals) through a change in the expression or          activity of certain enzymes.        -  That these effects are modulated by common gene variants (polymorphisms)   "
63874|NCT02449577|"     The objective of the study is to identify biomarkers for acute intake of beer and alcohol in     individuals with a high or low habitual intake. Furthermore, we wish to identify compounds     and metabolites in different types of beer and alcohol, which can serve as compliance markers     for intake under the test conditions (blood tests and urine samples). We also wish to     determine the acute effects of these beverages on plasma glucose and insulin response,     compared to regular soda.   "
63875|NCT02449564|"     This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and     PIK3CA amplication Refractory solid tumors.      sirolimus 1mg will be administered orally qd daily.      To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA     amplication Refractory solid tumors.   "
63893|NCT02449330|"     This is the clinical trial designed to assess the cardiac diastolic function of long term     treatment with teneligliptin compared to that without teneligliptin in patients with type 2     diabetes mellitus by two arms; one includes patients showing E/e' by echocardiography less     than 8, the other includes patients showing E/e' by echocardiography more than 8.   "
92135|NCT02080091|"     This observational study aims to assess the safety and effect of Iluvien® in DME patients     considered insufficiently responsive to available therapies in a real life setting in     Germany.   "
63876|NCT02449551|"     Volitinib is a potent and selective small molecule c-Met kinase inhibitor. Volitinib was     found to inhibit c-Met kinase at the enzyme and cell levels with IC50s of 4 nM for both     enzyme and Met phosphorylation in the cell. Consistent with its potent enzyme and cell     activity, volitinib was found to inhibit cell growth in vitro against tumors with c-Met gene     amplification in the absence of HGF stimulation with IC50s generally below 10 nM. It also     potently inhibited HGF-stimulated cell proliferation against tumors with c-Met overexpression     or carrying a HGF/c-Met autocrine loop.      This study is a single-arm, phase II study of votilinib in patients with advanced gastric     adenocarcinoma harboring MET amplification as a third line treatment Volitinib 800 mg will be     administered orally once a day for 21 days as one cycle.      To investigate the efficacy of volitinib in patients with advanced gastric adenocarcinoma     harboring MET amplification.   "
63877|NCT02449538|"     This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA     mutation and PIK3CA amplification Refractory Solid Tumors .      Everolimus 10 mg will be administered orally qd daily.      To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA     mutantion and PIK3CA amplification Refractory Solid Tumors.   "
63878|NCT02449525|"     The perfusion of microvascular free flaps is inevitable for completion of reconstruction in     the head and neck area. In some patients microvascular anastomosis is impossible because of     arteriosclerotic changes, different oncological interventions, and consecutive vessel     depletion at the neck. The aim of the project is to establish an innovative system for     extracorporeal perfusion of microvascular free flaps after ingrowth of new vessels from the     wound bed have taken place. Afterwards, no further perfusion of the vascular pedicle is     required for free flaps to survive and provide functional and aesthetic reconstruction.   "
63879|NCT02449512|"     Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's     disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic     lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current     gold-standard for evaluating LUT function. Nevertheless, the sensory situation of the LUT     cannot be investigated objectively. Furthermore, the current classification of the severity     of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the     LUT. Additional investigations therefore need to be established for assessing the sensory     situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for     investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI     individuals have not yet been investigated.      A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance     images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder     after SCI can be visualized. The structural presentation of bladder innervation will be     compared with the functional results, i.e. the SEP of the LUT in SCI individuals.      The primary objective of the proposed study is to elicit and characterize (latency,     amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals     suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury.      Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves     (N. tibialis, N. pudendus, N. medianus).      Moreover, the latency and amplitude of the SEPs from the bladder of individuals with     somato-sensory complete spinal cord injury will be compared with those from the bladder of     individuals with somato-sensory incomplete spinal cord injury.      Finally, the structural innervation of the bladder after SCI will be compared with the     remaining sensory function.   "
63880|NCT02449499|"     Depression and anxiety disorders, even when treated according to standard of care consisting     of individual treatment with medication and/or therapy, can be associated with significant     residual impact on quality of life. The purpose of this research is carry out an     observational study of an existing clinical treatment, adjunctive interpersonally focused     psychodynamic group therapy, to determine if this can improve quality of life for patients     who have residual symptoms of chronic depression and anxiety.   "
63881|NCT02449486|"     Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting     (CABG) or heart valve surgery to diminish postoperative pain.   "
63882|NCT02449473|"     A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2     Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma     Inadequately Controlled on Inhaled Corticosteroid.   "
63883|NCT02449460|"     The study addresses epidemiology of cardiovascular risk factors and major cardiovascular     diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants     in each will be included.   "
63884|NCT02449447|"     To asses the clinical effectiveness of blended cognitive behavior therapy (CBT): face-to-face     and internet-based treatment for adults with Major Depressive Disorder (MDD) in primary care     compared to treatment as usual.   "
63885|NCT02449434|"     This is a questionnaire based study investigating the relationship between the timing of     dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the     timing, nature, frequency and duration of dietary acid intakes and timing and frequency of     the participants toothbrushing. Signs of the participants erosive tooth wear will then be     recorded   "
63886|NCT02449421|"     The purpose of the study is to compare the impact of two strategies to sustain and improve     the delivery of an evidence-based psychotherapy for PTSD, Cognitive Processing Therapy (CPT)     in three different mental health systems. These approaches are based on two different     theories of what is necessary to promote successful implementation. We will examine whether     these strategies lead to improved patient outcomes, clinician skill, proportion of clients     who receive CPT, and other outcomes that are relevant to the implementation of evidence-based     psychosocial treatments. By examining these questions in 3 different mental health systems,     we will also examine whether the implementation strategies yield different results in     different systems.   "
63887|NCT02449408|"     The purpose of this study is to evaluate the accuracy of a new device that may be used for     the evaluation and management of malnourished infants and children. The device will measure     the levels of two hormones made by fat tissue: leptin and adiponectin.   "
63888|NCT02449395|"     This study is designed to collect data on precipitating factors, diagnosis, morbidity,     therapy, quality of life, and symptom severity, etc. informations in patients with     fibromyalgia.   "
63889|NCT02449382|"     The patients with severe hypernatremia who received conventional treatment are often     undertreated. Continuous venovenous hemofiltration (CVVH) can effectively remove solute or     water from circulation system. Several case reports demonstrated that CVVH could effectively     decrease serum sodium concentration of the patients with severe hypernatremia. The use of     CVVH for acute severe hypernatremia in critically ill patients could improve patient survival     by effectively decreasing the serum sodium concentration to a normal level.   "
63915|NCT02449044|"     This study will assess the safety of long-term tolvaptan use in patients previously enrolled     in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia     in the context of tolvaptan therapy and underlying disease states.   "
63895|NCT02449304|"     All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB)     in the absence of recognizable pelvic pathology, as determined by one or all of a normal     pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy     that persists despite treatment with recommended pharmacological agents(1,2), who have no     desire to preserve their fertility and are willing to have an endometrial ablation will be     invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial     ablation in either an inpatient or outpatient setting according to their preference.      Outcomes will be assessed by administering postal questionnaires to measure menstrual     bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline     and at 6, and 12 months after ablative treatment. After the main study, there will be an     additional evaluation of the long-term effects of outpatient ablative treatments of the     endometrium by postal survey at 5 years.   "
63896|NCT02449291|"     Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless,     dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established     PONV, in patients who have not had prior PONV prophylaxis.   "
63897|NCT02449278|"     The standard treatment approach for patients with stage III-IV DLBCL is combination     chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was     associated with improved in-field control and event-free survival. However, it is uncertain     for the radiotherapy field size to treat for these patients after chemotherapy.     Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for     patients with stage III-IV DLBCL. There is not a clinical trial to research whether the     sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the     same efficacy as IFRT and decrease toxicities related to radiotherapy.   "
63898|NCT02449265|"     The most common option of radiotherapy for patients with limited-stage DLBCL is     involved-field radiotherapy (IFRT). The more limited radiotherapy field size changing from     IFRT to reasonable margin from gross tumor has been reported to maintain the high rates of     local disease control, while minimizing the risks of radiation-induced toxicities. However,     the research didn't analyze whether the efficacy of consolidation involved-site radiotherapy     (ISRT) be affected by the response of chemotherapy. The biologic definition of clinical     target volume (CTV) of ISRT and actual radiotherapy field size need to be ascertained.   "
63899|NCT02449252|"     Radiotherapy (RT) is an important option for patients with limited stage FL. The recommended     approach for patients with limited stage FL by The National Comprehensive Cancer Network     (NCCN) is 24Gy~30Gy consolidation RT following effective systemic therapy. There is no     universal consensus for a ''standard'' RT field size in the treatment of limited stage FL.     The involved-site radiotherapy (ISRT) has been treated effectively for these patients.     However, the certain target volumes of ISRT need to be defined for patients with limited     stage FL after effective chemotherapy.   "
63900|NCT02449239|"     Because of the high risk for development of muscle invasive disease, cystectomy is     recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence     following intravesical therapy. Vicinium is an experimental agent that may provide an     alternative to cystectomy   "
63901|NCT02449226|"     ICU patients are at high risk of ionic or metabolic disturbances during the course of their     critical illness. Some of these disturbances might be life-threatening and require rapid     response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin     and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid     and appropriate therapy. This technology has largely improved the quality of care in ICU.     However, the accuracy of the measurement of those parameters had to be close enough to the     reference method, usually perfomed in the central lab but time consuming. Recently, a novel     generation of blood gas analyser has been released. Among them, the RapidPoint 500 is mounted     with a 28-day cartridge which provides automatic calibrations and quality controls several     times a day. Such a technology dramatically decreases the need for labs technical     interventions. To date, there is no data reporting the accuracy of this device. Therefore,     the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference     measurement performed at the central laboratory (Beckman&Coulter AU5800 for electrolytes and     Beckman&Coulter DXH for hemoglobin).   "
63902|NCT02449213|"     This prospective, longitudinal study of Chinese American immigrants will examine whether     psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are     associated with markers of type 2 diabetes risk over time, and whether such associations are     mediated by inflammatory pathways.   "
63903|NCT02449200|"     Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive     effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a     research gap exists for optimal management in the first 12 weeks and short-term natural     history of the condition is unclear, although thought to be favourable within the first 4     weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to     investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and     upper limb unloading tape compared to advice to stay active, on disability, pain and other     biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The     hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in     self-reported disability and pain, compared to advice to stay active, in patients with acute     / sub-acute cervical radiculopathy. A secondary study objective is to identify whether     variables from the baseline examination, group allocation and aetiology confirmed by MRI can     predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be     diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation,     allocation concealment, blinded assessment and intention to treat analysis will be employed.     Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability     and their rating of recovery will also be recorded by telephone interview at 6 months. An     internal pilot feasibility study will be undertaken in advance of the main study to test     recruitment and retention strategies. Statistical analysis of differences between groups will     be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be used     to explore predictors of outcome.   "
63904|NCT02449187|"     A randomized, open-label, single dose, crossover study to investigate the effect of food on     the pharmacokinetics of JLP-1310 in healthy male volunteers.   "
63905|NCT02449174|"     The objective of the study is to investigate the safety of a frozen or lyophilized inoculum     administered, respectively, by retention enema or capsules in patients with recurrent C.     difficile associated diarrhea (RCDAD).      This is a single center, randomized, parallel assignment, open label safety study conducted     in subjects with RCDAD. Fifty subjects will be enrolled in the study and randomized at 1:1     ratio to receive frozen filtered intestinal bacteria via retention enema or lyophilized donor     intestinal bacteria. All subjects will be followed for a total of 3 years after study     completion.      Donors will be enrolled and screened at the laboratory in the Center for Infectious Diseases     at University of Texas School of Public Health (UT-SPH). The donors will come from a variety     of places, including the UT-SPH. We will screen at least 20 donors to recruit at least 15     qualified donors.      Recipients may self-refer but must have a physician who agrees to accept care of the patient     following fecal microbiota transplantation (FMT). Subjects consenting to treatment at Baylor     St. Luke's Medical Center (BSLMC) and the UT-SPH must be willing to self-pay for the FMT in     the amount of $1,500. There will be no insurance accepted. Subjects undergoing retention     enema will be treated as outpatients at either at BSLMC, Kelsey-Seybold Clinic, or at the     Memorial Hermann in the Texas Medical Center. All subjects taking capsules with lyophilized     intestinal bacteria will be seen at UT-SPH. Once the procedure is completed, the recipient's     care will be returned to their physician. We will screen at least 75 recipients to recruit 50     qualified recipients.      The primary endpoint is to evaluate the safety of FMT by rectal or oral routes with secondary     endpoint related to efficacy prevention of RCDAD. In order to monitor any health effects for     safety, participants will be contacted pre- and 7, 14, 30 days, then monthly basis for the     first 90 days after FMT and quarterly till 3 years after FMT. The following procedures will     be completed: review recipient diary with the recipient to ensure that the following     information is recorded correctly and a fresh stool sample will be collected from recipient,     tested for C. difficile toxins and an aliquot (2mL) stored at -80C for microbiome analysis.     Recipients will be contacted by phone for their diarrhea status on monthly basis till 90 days     after FMT, then on quarterly basis till 3 years after FMT.   "
63906|NCT02449161|"     Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined     by International Federation of Gynecology and Obstetrics as the perception of menstrual     volume increased regardless of the frequency, duration and regularity. Some studies report     that up to 30% of women will suffer from heavy periods during their lifetime. The first line     treatment of heavy bleeding is medical. However, a significant proportion of women require     surgery. Until the 80s, hysterectomy was one of the only surgical options and often performed     as the first line treatment. Since twenty years now the endometrial ablation has become a     preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a significant     proportion of patients suffering from this type of problem. Endometrial ablation is much less     invasive and morbid than hysterectomy, however, many patients do not achieve a complete     amenorrhea with endometrial ablation and about 15% may have to require a new intervention,     such as hysterectomy, following the persistence of menstrual problems. A Cochrane review     published in 2013 showed that the satisfaction rate following endometrial ablation is high at     70-80% and about 35% of women have amenorrhea. The complete destruction of the endometrium is     the most important predictor of the success of the procedure. Studies have shown that better     results are obtained when the surgery is performed when the endometrium is thin or     immediately following menses or following administration of a hormonal agent causes atrophy     of the endometrium. One of the agents studied to prepare the endometrium before ablation is     medroxyprogesterone acetate (MPA) as injectables (DMPA) and oral. Progestins have an     antiproliferative effect on the endometrium. In recent years, numerous studies have examined     the use of various agents preoperatively, including MPA and DMPA to facilitate surgery by     reducing the thickness of the endometrium. However, few studies have focused on the     conditions of the post-operative period to promote the therapeutic response to the     intervention. The investigators hypothesis is whether the MPA administered in immediate     post-operative would inhibit proliferation of endometrial cells responsible for the     persistence of menstruation and optimize the clinical response to endometrial ablation.   "
63907|NCT02449148|"     This study evaluates the effect of intermittent calorie restriction versus continued calorie     restriction on weight loss, gene expression profile of subcutaneous adipose tissue and     abdominal fat distribution.   "
63908|NCT02449135|"     The purpose of this study is to evaluate the safety and efficacy of nano drug interventional     therapy using digital subtraction angiography（DSA） for pancreatic cancer. The nano drug is     made by mixing Gemzar® with Compound Glycyrrhizin Injection.   "
63909|NCT02449122|"     The purpose of this study is to evaluate the safety and efficacy of nano drug interventional     therapy using digital subtraction angiography（DSA） for lung cancer. The nano drug is made by     mixing Gemzar® with Compound Glycyrrhizin Injection.   "
63910|NCT02449109|"     The purpose of this study is to evaluate the safety and efficacy of nano drug（Gemzar® mix     with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction     angiography（DSA） for liver cancer.   "
63911|NCT02449096|"     Background: An anatomical reconstruction of ankle congruity is an important prerequisite in     the operative treatment of acute ankle fractures. But, despite an anatomic reduction,     patients suffer from residual problems like chronic pain, stiffness, persistent swelling and     instability after these fractures. There is growing evidence, that this poor outcome is     related to the concomitant traumatic intraarticular pathology. Therefore, supplementary ankle     arthroscopy has been proposed in acute ankle fractures as it is a valuable tool to confirm     the anatomic reposition and to further identify and manage associated intraarticular     injuries. The arthroscopic treatment of these pathologies might result in a better outcome     after complex ankle fractures. Nevertheless, until now, the vast majority of ankle fractures     are managed by open procedures only. Still, indications for arthroscopically assisted open     reduction and internal fixation (AORIF) are not clearly stated, and the effectiveness of     AORIF compared with open reduction and internal fixation (ORIF) has not yet been determined     for complex ankle fractures. In this context, only a prospective randomized study can     sufficiently answer these open questions. Therefore, the investigators plan a randomized     controlled trial intended to report the short-, midterm- and long-term follow-up of patients     who underwent operative treatment of acute ankle fractures - with and without ankle     arthroscopy.      Methods/Study design: The investigators will perform a randomized controlled trial evaluating     the effect of AORIF compared to ORIF with a sample size of 40 patients per group. The     investigators include patients with an acute ankle fracture after written informed consent.     Primary outcome of the investigators' study is the difference of the AOFAS score (American     Orthopedic Foot and Ankle Society) between the intervention (AORIF) and comparison (ORIF)     group after a follow-up of 2 years. Several secondary outcome parameters will be assessed as     well. Statistical analysis will be performed using a two-sided Student`s t-test.      Discussion: Until today, there are only two randomized controlled trials evaluating the     effect of open reduction and internal fixation (ORIF) compared to arthroscopically assisted     open reduction and internal fixation (AORIF). Both studies only included patients with     isolated fractures of the distal fibula at the level of the syndesmosis. These are the most     simple fractures that are regularly treated operatively. Both studies documented a high     incidence of intraarticular disorders in the AORIF group, but only one could show significant     better results in the AORIF group. Moreover, several other studies could consistently     demonstrate that the intraarticular damage is even more pronounced the more complex the     fracture is. Consequently, a more distinctive effect of arthroscopy in complex fractures     involving two malleoli or more has to be assumed when compared to these simple fractures.   "
63912|NCT02449083|"     There is preliminary evidence that a dynamic T2 Preparations Puls sequence by cardiac magnet     resonance imaging can differentiate between oxygenated and deoxygenated blood.      In adult patients with inborn heart defects this has not yet been researched.     Therefore,patients with ventriculoperitoneal shunt, septal and atrio-septal shunt should be     examined. Also, patients with chronic obstructive pulmonary disease should be examined.      The aim of this study is the validation of a novel magnet resonance sequence in terms of a     distinction of oxygenated blood to deoxygenated blood in comparison to invasive method of     measuring cardiac catheterization.   "
63913|NCT02449070|"     The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in     patient with ST-segment elevation acute myocardial infarction.   "
63914|NCT02449057|"     Arizona has created a pilot program for juvenile probationers called Juveniles under     Supervision and Treatment (JUST), which includes swift and certain, but modest responses, to     technical violations of the terms of juvenile probation. JUST targets high- and medium-risk     juvenile probationers and its stated objective is to reduce violations and overall     incarceration of youth in the program. The JUST pilot is being implemented under the     authority of the Arizona Governor's Office for Children, Youth and Families (GOCYF) and the     Administrative Office of the Courts (AOC).   "
63916|NCT02449031|"     This is a multicenter, prospective, two cohort, observational study over a 5-year period in     Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will     collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical     outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on     microbiological and safety assessments.   "
63917|NCT02449018|"     To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo     administered orally, on airway function, lung volume, and quality of life in patients with     chronic obstructive pulmonary disease (COPD)   "
63918|NCT02449005|"     Systemically healthy periodontitis patients are recruited from new referrals to the     Department of Periodontology and Biology of Implants, AUTh. After completion of non-surgical     periodontal treatment those subjects who have at least one interdental osseous defect with     probing pocket depth and clinical attachment level of ≥ 6mm and an intrabony component of ≥     3mm with no endodontic or furcation involvement are randomly allocated into one of the three     treatment groups. Group A receives regenerative treatment using autologous bone marrow     mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and     seeded into collagen scaffolds enriched with fibrin glue; in Group B, a collagen fleece     enriched with fibrin glue devoid of stem cells fills the osseous defect; Group C receives     open flap debridement retaining the soft wall of the defect. Thereafter, subjects are     followed for 12 months and are repeatedly assessed based on clinical, radiographic,     immunological and microbiological parameters.   "
63919|NCT02448992|"     Background. During the clinical course of patients with locoregionally advanced     non-small-cell lung cancer (LA-NSCLC) who have undergone aggressive treatment, brain     metastasis (BM) is a frequent seen pattern of disease relapse, which cannot be ignored. It     still remains unresolved whether prophylactic cranial irradiation (PCI) via whole brain     radiotherapy (WBRT) should be recommended for NSCLC patients with stage III or pathologically     nodal positive disease. Actually, PCI would significantly decrease the incidence of BM;     however, potential WBRT-related neurocognitive function (NCF) sequelae are indeed a concern,     which has made PCI seldom applied in clinical practice. In terms of the time course of     WBRT-induced NCF decline, it might vary considerably according to the specific domains which     are selected to be measured. Early neurocognitive decline principally involve impairments of     episodic memory, which has been significantly associated with functions of the hippocampus.     This study thus aims to explore the impact of PCI on the subsequent risk of developing BM and     the multi-domain neurobehavioral functions in our eligible patients.      Methods. Potentially eligible subjects are postoperative NSCLC patients with a status of     pathologically nodal metastasis (pN+). Patients randomly assigned to the PCI arm will undergo     the course of hippocampal-sparing PCI after they complete the fourth course of adjuvant     platinum-based chemotherapy. Radiotherapy dose will be 3000 cGy in 15 fractions during three     weeks. Except for the administration of hippocampal-sparing PCI, patients assigned to the     observation arm should receive the same baseline and follow-up brain imaging examinations and     neurocognitive assessments as those in PCI arm. Accordingly, a battery of neuropsychological     measures, which includes 7 standardized neuropsychological tests (e.g., executive functions,     verbal & non-verbal memory, working memory, and psychomotor speed), is used to evaluate     neurobehavioral functions for our registered patients.      Expected results. This randomized controlled study aims to verify that the incidence of BM     still can significantly be reduced by hippocampal-sparing PCI; additionally, NCF preservation     regarding neurobehavioral assessments might also be achieved by hippocampal-sparing PCI as     compared with the observation arm without PCI. No matter what the final results present, it     is believed that this randomized controlled trial (RCT) will provide us solid evidence     concerning the exact value of hippocampal-sparing PCI in our patient setting.   "
63920|NCT02448979|"     Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical     resection remains the most effective method for this malignancy. Although different     approaches have been studied for the surgical resection of thoracic esophageal cancer, little     evidence has been achieved due to lack of large scale multicenter randomized trials with     regard to this issue: whether left transthoracic approach or right transthoracic approach is     the optimal surgical approach for treating middle and lower thoracic esophageal cancer     without upper mediastinal lymph node metastasis. The purpose of this study is to compare the     postoperative local recurrence rate and long-term outcome of esophagectomy through left and     right transthoracic approach in the middle and lower thoracic esophageal cancer patients     without preoperative upper mediastinal lymph node metastasis.   "
63921|NCT02448966|"     Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection     remains the most effective method for this malignant disease. VATS esophagectomy has become     more and more popular in China and around the world. Although VATS esophagectomy has been     proven to be effective in preventing respiratory complications, there is still no ample     evidences to demonstrate that VATS esophagectomy is as effective as traditional     three-incision esophagectomy in lymph node dissection and is equal or superior in long-term     survival. The purpose of this large scale prospective observational study is to compare the     minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision     esophagectomy in lymph node dissection, postoperative recovery, postoperative complications,     and long-term survival.   "
63922|NCT02448953|"     The purpose of this study is to compare the lymph node dissection results and prognosis in     thoracic esophageal carcinoma patients without cervical lymph node involvement by     preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field     lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the     right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to     indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.   "
63923|NCT02448940|"     The investigators aimed to study the effect of supplementation with species of Lactobacillus     on anthropometric measurements, body composition, appetite and serum lipid profile in     overweight and obese adults   "
63924|NCT02448927|"     This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV)     on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI)     procedure. Patients will undergo a physical exam, coronary angiography and computed     tomography angiography before TAVI. The randomization for direct or non-direct TAVI ( with     BAV or without BAV) will take place 24 hours prior to the procedure by the core lab at     Hippokration Hospital in Athens. The same lab will analyze in blind fashion the results of     all the imaging modalities for each patient. The patients will be followed during the     hospital stay and at 30 days and 1 year thereafter by echocardiography. The procedure of     predilatation will be at the operator's discretion.   "
64016|NCT02447731|"     Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead     space.   "
63925|NCT02448914|"     This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa     on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All     patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and     Duodopa (levodopa and carbidopa), in randomized order.   "
63926|NCT02448901|"     The influence of different doses of edoxaban on physical characteristics of the clot and     thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood     samples collected from patients treated for heart failure (with and without     hypercoagulability) and from healthy volunteers (with and without hypercoagulability). This     in vitro experiment will help us to:      (i) detect qualitative anticlotting properties of edoxaban. (ii) quantify the anticlotting     properties of edoxaban.   "
63927|NCT02448888|"     Objective: The purpose of this study is to investigate the effects of a adapted exercise     program and general exercise recommendations compared with only general exercise     recommendations for the management of chronic back pain among the workers of BSH (Bosch     Siemens Hausgeräte), a manufacturing company.   "
63928|NCT02448875|"     This study is to assess the safety and effectiveness of the use of visco-assisted CyPass     Micro-Stent implantation for the lowering of intraocular pressure (IOP) in patients who have     open angle glaucoma (OAG).   "
63929|NCT02448862|"     In this retrospective study, postoperative pain score, PCA-related complications, the risk     factors for requirement of rescue analgesics and antiemetics will be evaluated in young and     elderly patients, respectively, using fentanyl-based IV PCA during postoperative 48 hours     after various surgeries.   "
63930|NCT02448849|"     Nonunion of long bones would occur in almost 10% of fractures and because of its long term     and complicated treatment, is known as a therapeutic challenge for both of the surgeons and     patients.      Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the     best candidates for this kind of treatment.      Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in     combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as     the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m     and 12 months after implantation.      The Spss(v16) software will be used for data analysis.   "
63931|NCT02448836|"     Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes     significant suffering in 5% of women of reproductive age worldwide. The prominent symptoms     are depressed mood, irritability, mood lability and anxiety. Treatment options for PMDD are     limited, with 40% non-responders.      Deep transcranial magnetic stimulation (dTMS) is a novel therapeutic technique, which is     based on modulating neural activity by inducing an electric field in the brain. To date, dTMS     was found to be an effective treatment for depression, which is highly comorbid with PMDD.      The investigators propose to study the effect of dTMS on PMDD patients in a prospective     treatment study.   "
63932|NCT02448823|"     The study will test a novel demand generation strategy, Stylish Man/Stylish Living, to     increase uptake of Combined HIV Prevention (CHP) in Rakai, Uganda. CHP includes     evidence-based interventions, including safe voluntary medical male circumcision (VMC),     antiretroviral therapy (ART), prevention of mother to child transmission (p-MTCT) and     behavioral interventions. With President's Emergency Fund for AIDS Relief (PEPFAR) funds, the     Rakai Health Sciences Program (RHSP) provides CHP in Rakai District, Uganda. Our ongoing 54     village Rakai Community Cohort Study (RCCS), with community HIV prevalence ranging from 6% to     42%, provides longitudinal data on rates of CHP coverage and on HIV incidence. The     investigators have preliminary evidence that CHP is reducing HIV incidence in Rakai, but     coverage remains suboptimal (as elsewhere in Africa), particularly in men, reducing program     impact. Our data suggest that CHP supply is not the limiting factor, but that there is a     deficit in demand.      Based on extensive qualitative research, the investigators have developed and piloted an     innovative male-focused CHP demand generation strategy, the Stylish Man/Stylish Living     Program (SMLP) which is male-friendly without excluding exclude women. The SMLP strives to     demedicalize CHP by deemphasizing health-focused messages and instead stressing taking     charge of your life. The SMP has two distinct but related elements: (1) mass media (MM) via     radio and posters; and (2) community-level mobilization via the Stylish Man/Stylish Living     Event (SMLEvent) which includes multimedia media (the Stylish Van, videos, music, health     promoters) into which the investigators have embedded CHP promotion, and immediate access to     services. In this study, the investigators will conduct a 3 year cluster randomized trial of     MM plus SMLEvents (intervention arm) compared to MM alone (control), in 25 RCCS communities     per arm aggregated into ~10 clusters per arm (50 communities in all). The primary outcome     will be intent-to-treat community-level rates of CHP coverage by arm. The investigators will     also monitor rates of key behaviors and HIV incidence, and compare them between arms and to     rates observed in communities in each arm prior to study initiation (secondary outcomes).   "
63933|NCT02448810|"     The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination     with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase     II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination     with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects     with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice as     third or fourth treatment line in subjects with progressive measurable metastatic colorectal     cancer (mCRC).   "
63934|NCT02448797|"     Adjuvant therapy has been proved effective in treating earlier stage or less advanced     non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as     adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR     mutation. The primary endpoint is disease-free survival.   "
63935|NCT02448784|"     To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil     hydrochloride in clinical practice as well as its proper use information in participants with     DLB.   "
63936|NCT02448771|"     This research study is studying a drug called Palbociclib in combination with Bazedoxifene (a     type of endocrine therapy, which prevents breast cancer cell growth by blocking estrogen     stimulation) as a possible treatment for this diagnosis.      The names of the study interventions involved in this study are:        -  Palbociclib        -  Bazedoxifene   "
63937|NCT02448758|"     The investigators propose to create a database at the regional level, the principle is to     include all patients in whom a mutation was detected from a single platform (Lille). The     creation of this regional cohort, smaller than the national cohort of Biomarkers France, will     perform a more comprehensive collection of clinical data, and molecular monitoring data of     patients included. To increase the completeness of the collection of information, it will not     be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated     to this activity.   "
64707|NCT02438696|"     The primary objective is to investigate the relative bioavailability of two newly developed     tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is     the comparison of several pharmacokinetic parameters between the treatments.   "
64303|NCT02443987|"     The primary aim of this study is to compare, in women undergoing tension-free vaginal tape     (TVT) insertion under sedation and local anaesthetic infiltration, the time interval of first     void following surgery between a group of patients who received intravenous fluids to those     who did not.   "
63938|NCT02448745|"     A cluster-randomized control trial will study the effect of insecticide-treated wall lining     on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study     will receive insecticide-treated wall lining covering their walls and ceilings in addition to     long-lasting insecticidal nets, while the other half will be protected by existing     long-lasting insecticidal nets.   "
63939|NCT02448732|"     The purpose of this study is to investigate the role of intravitreal injection of     anti-vascular endothelial growth factor (VEGF) therapy in prevention and control of     ophthalmological neovascular diseases, in order to find a new strategy of treatment for     ophthalmological neovascular diseases   "
63940|NCT02448719|"     The purpose of this study is to characterize the safety and tolerability profile of TAK-792     when administered as a single oral dose in healthy Japanese and Caucasian male participants.   "
63941|NCT02448706|"     The goal of this project is to find out if the way a hearing aid processes a sound signal     should be determined in part by an individual's cognitive characteristics. We anticipate that     the outcome of this work will be a battery of assessments that will guide hearing aid     processing for older patients with hearing loss.   "
63942|NCT02448693|"     This study is designed to evaluate the diagnostic accuracy of Narrow Band Imaging (NBI)     compared with High Definition White Light colonoscopy (WLE) for detection of residual     neoplasia in subjects with piecemeal polypectomy scars.   "
63943|NCT02448680|"     The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate     dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the     treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII     or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years     old).   "
63944|NCT02448667|"     Patients suffering from the metabolic myopathy Glycogen Storage Disease type IIIa (GSDIIIa)     have a problem releasing sugar stored in cells that is needed for energy production. This     causes several systemic impairments, but only recently have the exercise-related symptoms in     the muscles been examined. A previous study showed signs that intravenous infusion of glucose     relieves some of these symptoms. The purpose of this study is to investigate in a randomized     and placebo-controlled fashion whether oral ingestion of sugar can alleviate muscular     symptoms in patients with GSDIIIa.   "
63945|NCT02448654|"     The purpose of this study is to use a medication tolcapone and or placebo to test if the     symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental     reasoning in female smokers over a 72 hour period.   "
63946|NCT02448641|"     Controlled study of stereotactic, intracranial injection of SB623 cells in patients with     fixed motor deficits from ischemic stroke   "
63947|NCT02448628|"     This study is a multi-center, open label, dose titration, exploratory study to evaluate     efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal     impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood     pressure.   "
63948|NCT02448615|"     In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only     2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of     the causes of child mortality is necessary to guide research efforts aimed at tackling this     important global health problem. Prospective birth cohort studies present an opportunity to     examine the relationships between early-life exposures and multiple health and non-health     related outcomes including death, illness, and socioeconomic factors. In this study, the     investigators will provide insight into the underlying causes of child mortality by     collecting data on early-life exposures and health and non-health related outcomes in the     first year of life.   "
63949|NCT02448602|"     With primary insomnia as the research object, by the method of multi-center RCT and needle     single cavity and different acupoints compatibility treatment for primary insomnia, to     Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and     Polysomnogram(PSG) as the means, such as the single cavity with different acupoints     compatibility evaluate clinical curative effect of treating primary insomnia.   "
63950|NCT02448589|"     A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic     and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.   "
63951|NCT02448576|"     The purpose of this study is to compare whether prophylactic cranial irradiation in patients     with advanced triple negative breast cancer who had a response to first line chemotherapy     could prolong brain-metastasis free survival.   "
63952|NCT02448563|"     In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based     weight loss program to reduce obesity among postpartum African American (AA) adult women that     can be integrated into a postpartum care model within a clinical setting.   "
63953|NCT02448550|"     The purpose of this trial is to determine whether bivalirudin is non-inferior to     unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment     elevation myocardial infarction undergoing percutaneous coronary intervention.   "
63954|NCT02448537|"     This research study is investigating a drug called PM01183 alone and in combination with     chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic     or unresectable Sarcoma.   "
63955|NCT02448524|"     -  To evaluate the safety and efficacy of MiStent drug (sirolimus)-eluting stent system in          the treatment of coronary heart disease (CHD) in patients with primary in situ CHD (de          novo);        -  To evaluate operating performance of the MiStent drug (sirolimus)-eluting coronary stent          system.   "
63956|NCT02448511|"     This study evaluates the efficacy of local application of ozone gas in healing of infected     ulcers. Half the participants received conventional treatment with placebo generator and the     other half received conventional treatment with ozone generator.   "
63957|NCT02448498|"     The Strength Training Regimen in Normal Weight Diabetics (STRONG-D) study will examine the     effectiveness of different exercise regimen types in controlling diabetes for the normal     weight type 2 diabetes population.   "
63958|NCT02448485|"     TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of     minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic     aortic stenosis.   "
69474|NCT02376426|"     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and     Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult     participants.   "
63959|NCT02448472|"     Sepsis is a common cause for morbidity and mortality in critically ill patients. In USA, the     incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among     different clinic trails. In addition, clinician empirical select antibiotic according to the     epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In     China, the MDRO is much higher than western country. There is no study about the epidemiology     of sepsis in China. Therefore, it is necessary to conduct a study about it in China.   "
63960|NCT02448459|"     This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled     ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the     number of oocytes retrieved.   "
63961|NCT02448446|"     This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in     subjects with diabetic macular edema and lipid exudates in the central subfield.   "
63962|NCT02448433|"     Bright light therapy is an established treatment pathway for sleep and circadian disorders     and evidence suggests that it has antidepressant effects. The underlying mechanisms of these     antidepressant effects are not fully understood and results from previous studies are     somewhat variable. One of the important limitations of previous depression studies has been     the heterogeneity of samples in which bright light therapy has been administered.      The main aim of this study is to evaluate whether the antidepressant effects of phototherapy     in young persons with depression are modulated by changes in the sleep-wake cycle. We     hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant     response to phototherapy and that the magnitude of changes in depressive symptoms across the     course of the intervention will correlate with changes in the sleep-wake cycle.   "
63963|NCT02448420|"     This is a phase II, prospective, open-label, multicentre, Simon's two-stage-design study of     the combination of palbociclib plus trastuzumab, with or without letrozole, in     post-menopausal patients with HER2-positive locally advanced or metastatic breast cancer     (MBC) who have received chemotherapy and treatment with trastuzumab for their metastatic     disease.The aim of the PATRICIA study is test the hypothesis that the addition of Palbociclib     to standard therapy is well tolerated and can provide a benefit in progression-free survival     in patients with HER2-positive breast cancer previously treated for their metastatic disease.   "
63964|NCT02448407|"     Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and     platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also     recently recognized a regenerative cell potential improving the concentration of hyaluronic     acid and stabilizing angiogenesis in arthritic knees      This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees     intraarticularly infiltrated, and which patients would benefit most from treatment,     eliminating false expectations in the rest.   "
63965|NCT02448394|"     This study, to be conducted in southern Ethiopia, is a randomized community trial, evaluating     the use of local community support workers who provide for HIV patients education,     counseling/social support, and linkage to the HIV Clinic. Patients will be followed for at     least three years, with a primary goal of improving retention in HIV care, and secondary     goals of improving client knowledge, attitudes about being HIV-positive, feelings of social     support and clinical health status.   "
63966|NCT02448381|"     To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with     patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).   "
63967|NCT02448368|"     The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules     compared with RDEA3170 tablets.   "
63968|NCT02448355|"     All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about     1 year, will be offered to participate.      Retinal and choroidal structural changes will be assessed using swept-source OCT technology   "
63969|NCT02448342|"     Multi center, randomized controlled study, to determine if a significant decrease in the rate     of heart failure re-hospitalizations occurs during a follow-up period when - ReDS guided     treatment is used as an adjunct to standard of care.   "
63970|NCT02448329|"     This study is a single arm, single center phase II study of AZD1775 in combination with     paclitaxel in patients with advanced gastric adenocarcinoma harboring TP53 mutation as a     second-line chemotherapy.      Patients will receive AZD 1775 plus weekly paclitaxel combination regimen. The arm is     composed of 25 patients.      AZD1775 225 mg BID q 12 hours (x 5 doses) administered days 1~3 + paclitaxel 80 mg/m2 given     days 1, 8 and 15 of a 28 day cycle.      Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted at     screening every 16 weeks until objective disease progression .   "
63971|NCT02448316|"     The purpose of this study is to compare in a randomized controlled trial the effect of     endoscopic operation with the standard conservative treatmentprotocol with training     supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar     fasciopathia.   "
63972|NCT02448303|"     Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small     cell lung cancer.   "
63973|NCT02448290|"     This study is a single-arm, phase II study of selumetinib in combination with docetaxel in     patients with advanced gastric adenocarcinoma harboring MEK signature, RAS mutation or     amplification as a second line chemotherapy.      Selumetinib will be administered orally 75mg twice a day continuously. Docetaxel will be     administered as an IV infusion over 1 hour at 60 mg/m2 every 3 week of a 21 days schedule.   "
63974|NCT02448277|"     Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial     surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal     intubation, limited information presents in NTI. The aim of the study is to compare the     efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.   "
63975|NCT02448264|"     This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability,     pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending     doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy     Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug     BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have     in the body.   "
66184|NCT02419404|"     The investigators hypothesize that analysis of blood pressure will allow doctors to predict     whether or not blood flow from the heart (cardiac output) increases after intravenous fluids     are given.   "
63976|NCT02448251|"     AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective     Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer     patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by     irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the     activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of     EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth by     EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters: 1.     Irreversible binding to EGFR; 2. Efficiently suppresses the tumor cell with EGFR mutant and     has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR     T790M drug-resistant mutation.   "
63977|NCT02448238|"     The composition of the intestinal bacterial flora effects gut immunologic function and     intestinal barrier integrity. HIV infection impairs gut immune and epithelial function     resulting in an altered gut bacterial flora and leakage of gut bacterial products into the     bloodstream. These bacterial products can overstimulate the immune system leading to     increased inflammation and HIV disease progression. The investigators will investigate     whether oral supplementation of certain beneficial probiotic bacteria may attenuate these     processes in HIV infected women in Mali, Africa.      This is a single arm study to evaluate the effect of 12 weeks of combination oral probiotic     supplementation (VSL#3, Sigma-Tau Pharmaceuticals - containing 9 × 1011 bacteria of 8     species: S. thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium     infantis, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus paracasei, and     Lactobacillus bulgaricus) on plasma biomarkers of immune cell activation, and inflammation.     The study population will be 50 chronically HIV-infected but generally healthy, non-pregnant,     Malian women subjects with CD4+ T-cell count ≥ 350 cells/mm3 who are not receiving     antiretroviral therapy. Blood plasma/serum and fecal sampling will occur at baseline, 4, and     12 week as well as at 24 weeks. At these time points, probiotic will be dispensed, a medical     history will be obtained, and adherence will be assessed. Prior to study entry, subjects will     have eligibility and safety labs will be obtained and detailed baseline medical and symptom     histories, demographics, weight, and stool frequency information will be recorded. A stress     assessment questionnaire will be completed at baseline and week 12 to determine the effect of     this intervention on stress levels.      The primary study outcome is to assess change (baseline to 12 week) in plasma soluble CD14 (a     marker of monocyte response to bacterial endotoxin which has been associated with mortality)     with study probiotic. Other outcomes will include assessing change (baseline to 12 week) in     plasma interleukin-6, soluble CD163 (another monocyte activation marker), d-dimer (a marker     of coagulopathy), intestinal fatty acid binding protein (a marker of gut epithelial cell     injury) and fecal calprotectin (a marker of gut inflammation), as well as CD4+ T-cell counts,     self reported stool quality (using the Bristol Stool Scale), safety and tolerability of the     VSL#3 probiotic, and level of stress.   "
63978|NCT02448225|"     This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG)     positron emission tomography (PET)/computed tomography (CT) to the standard of care     fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer     or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common     building blocks of protein) called 18F-FSPG which may be able to recognize differences     between tumor and healthy tissue. Since tumor cells are growing, they need to make protein,     and other building blocks, for cell growth that are made from glutamate and other molecules.     PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer     than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.   "
63979|NCT02448212|"     The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699,     using Positron Emission Tomography (PET) scans with or without dosing of TS-121   "
63980|NCT02448199|"     Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic     in 375 subjects with knee osteoarthritis.   "
63981|NCT02448186|"     The proposed study will adapt a cognitive behavioral intervention to support high-risk MSM's     adaptive coping with minority stress, alleviate associated depression and anxiety, and reduce     HIV risk behavior. The adapted intervention is expected to increase awareness of the     unhealthy impact of minority stress; facilitate objective self-schemas in the face of     minority stress; and strengthen one's skills and self-efficacy for managing minority stress     and associated anxiety and depression to reduce risk for acquiring HIV.   "
63982|NCT02448173|"     OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and      addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase      IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's      own cancer cells to mobilize the body's immune system to prevent the return of colon      cancer following surgery.   "
63983|NCT02448160|"     The study will be a single centre, open-label trial. The patients will have a diagnosis of     refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will     be obtained from all patients. All patients will have an alfapump surgically inserted and in     addition will receive 8g of salt-poor Human Albumin Solution (20%) per 1 litre of Ascites     drained. This Intravenous administration will be intermittent (every month) and will take     place as a day patient. Patients will also receive standard of care, which may include, but     is not limited to, administration of diuretics, paracentesis and consideration for orthotopic     liver transplantation.   "
63984|NCT02448147|"     BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as     exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle     disability and exercise intolerance. The interval exercise training has been proposed as one     efficient method to heart failure patients. It seems that the main mechanism involved in the     benefit of the interval exercise training is shear stress. AIM: To study the interval     exercise training versus the continuous exercise training in the sympathetic activity and in     the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the     muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation,     quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and     female) with age between 30 and 60 years, left ventricular ejection fraction less than 40%     and functional class I, II and III. These patients will be randomized into three groups:     Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with     microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer,     cardiopulmonary exercise test and quality of life before and after end of the period of 03     (three) months.   "
63985|NCT02448134|"     This project evaluates a combination of policy and social influence interventions to reduce     adolescent alcohol use and its sequelae.   "
63986|NCT02448121|"     The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow     stem cells in sickle cell disease patients with osteonecrosis   "
64731|NCT02438384|"     This is a three arm pilot randomized trial. Patients will be assigned to:        1. Usual care        2. Video education in the ED        3. Video education in the ED plus phone follow-up at three days with geriatric pain          management specialist for all patients with pain >=4/10   "
63987|NCT02448108|"     The investigators will conduct a small pilot study to test the feasibility and acceptability     of treating bipolar disorder (BP) in primary care with online psychotherapy delivered both     with and without telephone, text, and email support from a clinical helper (CH). The ultimate     goal of this work is to provide preliminary data needed to design a larger scale     effectiveness study of online psychotherapy for treating BP in primary care.   "
63988|NCT02448095|"     This observational study aims at assessing the tolerability and safety profiles of Ponatinib,     a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is     used during the chronic phase of the disease, according to the Italian national compassionate     law 648/96.   "
63989|NCT02448082|"     Dandruff, also known as Pityriasis capitis, is a common condition which affects the scalp of     almost half the post-pubertal population regardless of race and gender. It is said that     dandruff affects at least 50% of the world's adult population and about 15 - 20% of the     world's total population. Dandruff is usually marked by flaking as well as itching and     irritation of the scalp which can also lead to greasiness. Dandruff can lead to physiological     and psychological issues and can be very distressing and embarrassing for the sufferer,     causing low self esteem and social problems. Current treatment options for dandruff include     many over-the-counter preparations, anti-dandruff shampoos and topical steroid applications     which are accompanied by numerous adverse effects. According to Lunar Pharmaceuticals     Ichthyol® Pale is a sodium salt of pale sulphonated shale oil in aqueous solution with     anti-microbial properties which can combat dandruff helping with the causative and     symptomatic relief of this condition.      The aim of the study is to determine the efficacy of Sodium Shale Oil Sulponate 1% shampoo in     the treatment of Pityriasis capitis. This will be evaluated using the Adherent Scalp Flaking     Score (ASFS) grading and the Visual Analogue Scale (VAS).   "
63990|NCT02448069|"     Background:      Our prior work with combination argatroban + recombinant tissue plasminogen activator (rt-PA)     (ARTSS-1: Phase IIa low-dose safety study; n=65 and ARTSS-2: Phase IIb randomized low and     high-dose study; n=90), demonstrated safety of the two drugs when delivered concomitantly and     recanalization rates were greater than with historical controls. Further, interim analysis of     neurological outcomes at 75 patients of the randomized Phase IIb trial, demonstrated a signal     of efficacy when compared to control (rt-PA alone) patients. However, rt-PA fails to     reperfuse brain in most patients with large thrombi, prompting several recent randomized     clinical trials which have demonstrated that intra-arterial therapy (IA) following rt-PA     substantially improves outcome in patients with distal carotid or proximal middle cerebral     artery occlusions. As a result, rt-PA + IA has become the new standard-of-care for many     patients with large arterial occlusions such as those treated in ARTSS-1 and 2. Therefore,     this study is necessary to explore the feasibility and safety of adding Argatroban in acute     ischemic stroke patients who also receive rt-PA followed by IA.      Primary Objective:      To demonstrate the feasibility and safety of treating stroke patients with Argatroban who     undergo usual thrombolysis care (intravenous rt-PA followed by IA).      Secondary Objectives:        1. Assess rates of ultra-early recanalization at commencement of IA;        2. Assess the completeness and pattern of reperfusion as obtained by IA; 3) Assess clinical          outcome   "
63991|NCT02448056|"     Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading     cause of cancer-related death worldwide. Treatments of HCC include surgical resection, local     therapies such as radiofrequency ablation and ethanol injection, transarterial     chemoembolization, sorafenib and best supportive care. However, even after successful     treatment such as surgical resection, most patients suffered from recurrence or progression     of the tumor. Because clinical staging systems cannot precisely predict the outcome of     patients with HCC, it's of great interest to search serum biomarkers for HCC. Among them,     alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC     after surgical resection of tumor or after local therapy is still uncertain.      MicroRNAs (miRNAs), 17- to 25-nucleotide non-coding RNAs, are frequently dysregulated in     cancer and emerging as novel non-invasive biomarker for cancer screening, diagnosis, monitor     therapy efficacy and predict prognosis. MiRNAs are stably expression in serum as their     resistance to endogenous RNase and easily storage with high stability. Several studies have     shown abnormal expression of human serum miRNAs in many cancers such as liver, colorectal,     and pancreatic cancer. The sensitivity of miRNA as a diagnostic biomarker of HCC could be     upto 80%. Using miRNA arrays can generate miRNA signatures and improve the sensitivity and     specificity of biomarker for tumor diagnosis and prognosis prediction.      In this study, the investigators will establish an miRNA platform as biomarkers for     diagnostic or prognostic tools of HCC. The investigators will also compare the miRNA     expression level before and after treatment in the serum and correlate the miRNA expression     between serum and tumor tissue.   "
63992|NCT02448043|"     Topical prostaglandin agents are used to help reduce eye pressure in glaucoma patients.     Bimatoprost (Lumigan 0.01%) is such an agent (Allergan, Inc.). Several of our patients on     bimatoprost and an observational study of patients on bimatoprost in another center reported     that fingernails grew longer and became less brittle using the topical eye drops to the eyes.     The purpose of the double-blinded study is to determine whether the application of the eye     drops directly to the proximal nail fold of one hand using the opposite hand as a control     will result in longer nails, less brittle nails, and reduced eye pressures should any of the     medication be absorbed into the systemic circulation.   "
63993|NCT02448030|"     Cardiovascular exercise adjustments are required during in order to redistribute blood flow     from non-exercising vascular areas to active muscles. This hemodynamic adjustments, which are     partially mediated by mechanosensitive and metabosensitive reflexes, ultimately increase     oxygen and nutrient delivery to exercising muscle tissues (Mitchell, 1990). Static handgrip     exercise has been shown to induce alterations in the arterial baroreflex function (Kim, 2005)     and activation of muscle metaboreflex that increases arterial blood pressure and peripheral     vasoconstriction, respectively. Functional electrical stimulation (FES) treatment used in     physical therapy in patients who are unable to tolerate conventional exercise showed to be a     good alternative for muscle strengthening (Sbruzzi, 2010) and to improve metabolic     abnormalities (Karavidas, 2006). However, the effect of FES on metaboreflex activation in     healthy individuals has never been investigated. Therefore, this study aims to evaluate the     metaboreflex activation induced by FES in upper and low limbs in healthy individuals, and     also to compare their results with the effects caused by isometric exercise.   "
63994|NCT02448017|"     Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic     patients with small lower jaws. Since small lower jaws are reported to be one of the main     reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used     to treat SDB children. Previously no study compared the effects of Herbst appliance therapy     with removable functional appliance on airway dimension, so it still remains unclear which     kinds of functional appliance is more suitable for improving airway dimension. This study     will assess the effect of Herbst appliance on airway dimension and compare the effects with     those of twin block appliance (a popular 24 hours used removable functional appliance, and     also commonly used to treat adult sleep apnea).   "
63995|NCT02448004|"     The primary objective of this study is to characterize the absorption and metabolic pathways     of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral     dosing of 14C-JNJ-63623872 in healthy adult male participants.   "
63996|NCT02447991|"     Suffering from dizzy spells and migraine headaches?      Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of dizziness.      University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM to     participate in a research study. The purpose of this study is to look at the natural history     of VM and learn more about common symptoms. Investigators also want to learn the effects,     both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used     for spells of dizziness in people with VM.      Patients may be eligible to participate if:        -  Patients are between the ages of 18 & 65        -  Patients have a history of vestibular migraine        -  Patients are able to maintain a vestibular symptom diary      The study includes 3 visits with compensation. All participants must complete questionnaires     on dizziness, headache symptoms, general health and well-being, mental health, and a     questionnaire on patient's satisfaction with study medication.   "
63997|NCT02447978|"     The purpose of this study is to assess duration of protection for GSK DTaP vaccines in     preventing pertussis.   "
63998|NCT02447965|"     The purpose of this study is to show that the use of preoperative rectus sheath blocks can     ultimately alleviate the need for using nondepolarizing muscle relaxants during certain     abdominal procedures.   "
63999|NCT02447952|"     Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral     Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new     meaningful measure(s) which might prove to be more effective than existing measures for     monitoring clinical function and disease course in ALS. The objective of this study is to     test novel measures of movement/physical activity, heart rate and speech and explore how they     measure disease progression by evaluating their relationship to gold standard measures of     function. This study will be conducted in two phases. A variable length Pilot Phase to test     biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately     5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while     wearing the accelerometer and electrode. Subjects will also continuously wear the     accelerometer and electrode in their routine home-life setting for approximately 3 days after     the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the     study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted     to evaluate how measures of movement/physical activity, speech and Heart Rate Variability     (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be     enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function     and perform a series of set reference tasks while wearing the accelerometer and electrode. In     between clinic visits, every month subjects will attach the accelerometer and electrode and     wear it for approximately 3 days in their home. A telephone contact with the subject will be     made by the site at the end of each 3-day home monitoring period.      All third party trademark rights are the rights of their respective owners.   "
64000|NCT02447939|"     Present clinical study will be conducted in China to evaluate the pharmacokinetics (PK) of     single and repeat oral doses of dabrafenib alone and dabrafenib and trametinib in     combination, the safety profile and the clinical activity of dabrafenib in combination with     trametinib in Chinese melanoma subjects with BRAF V600E/K mutation. Approximately 20     evaluable subjects will be enrolled in the study, out of which, the first 10 subjects will be     enrolled into cohort A (Part I and II) and remaining 10 subjects will be enrolled in cohort     B. Subjects in cohort A (Part I) will receive dabrafenib 150 mg twice daily (BID) and     subjects in cohort A (Part II) and Cohort B will receive combination of dabrafenib 150 mg BID     and trametinib 2 mg once daily (QD). Study treatment will continue until disease progression,     death or unacceptable toxicity. After disease progression, all enrolled subjects will be     followed up for overall survival. The study will be completed after all subjects have died or     surviving subjects have had at least 5 years of follow-up, whichever occurs first.   "
64001|NCT02447926|"     Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or periphery can control     immune responsiveness to auto- and allo-antigens. However, there have been few efforts to     harness the therapeutic potential of isolated Tregs to control graft rejection and inducing     transplantation tolerance in solid organ recipients. In order for Tregs to be used as a     clinical treatment, the following properties are necessary: ex vivo generation of sufficient     numbers of cells, migration in vivo to sites of antigenic reactivity, ability to suppress     rejection in an alloantigen-specific manner, and survival/expansion after infusion. The and     others have demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of     these cells to down-regulate allogeneic immune responses in vitro, and 3) the efficacy of     Treg for prevention of allograft rejection in animal models. In kidney transplant, the     investigators have developed strategies for the ex vivo expansion of naturally occurring     human Tregs (nTregs) from leukapheresis products that would allow for the clinical employment     of this cellular therapy. The investigators are also interested in this approach in patients     with end stage liver disease (ESLD) undergoing liver transplantation (LT). Our central     hypothesis is that alloreactive human nTreg with suppressive action can be expanded ex vivo     from ESLD patients (this proposal) and used to both prevent liver transplant rejection and     facilitate the minimization and withdrawal of drug-based immunosuppression (future     proposals). This application will further define and validate efficient methods for ex vivo     expansion of human CD4+CD25+CD127- FOXP3+nTregs cells in ESLD. The investigators herein     propose to use leukapheresis products obtained from patients with ESLD to further refine and     optimize protocols for expansion of Tregs. Suppressive function of expanded cells will be     assessed using in vitro assays of alloreactivity (mixed lymphocyte culture).   "
64002|NCT02447913|"     The proposed project will help in assessing the effectiveness of a demand-side financing     project that provides family planning services bundled in a package of postnatal care and     infant immunization services. This approach will use postnatal and infant health as a gateway     to family planning - building confidence among the client and her influencers in the provider     and repositioning family planning as part of a continuum of care to ensure the health of the     mother and the infant. Vouchers will help in creating demand among poor women for the Family     planning and child immunization. Also incentivizing providers against each voucher will help     in improving their counselling skills as they will spend more time with voucher clients     resulting is a satisfied client and better compliance with Family planning methods.   "
64003|NCT02447900|"     Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for     image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with     locally advanced non-small cell lung cancer (NSCLC)   "
64004|NCT02447887|"     This is a Phase I/II trial of the combination pegylated IFN-alpha 2b with ixazomib in     metastatic renal cell carcinoma (mRCC). Researchers believe that by disabling the protein     complex NF-kB, which controls the transfer of genetic information; using the study drug     Ixazomib, they can promote necrotic cell death of RCC using interferon alpha - 2b. They     hypothesize that the combination of ixazomib with IFN will lead to increased necrotic cell     death in RCC tumors and consequent clinical benefit to patients.      Patients will receive ixazomib capsules and pegylated IFN alfa 2b injection in this research     study. Treatments will be given weekly and 4 weeks of treatment make up one cycle.   "
64005|NCT02447874|"     The purpose of this study is to determine whether giving extra arginine to patients with     sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease     pain scores, decrease need for pain medications or decrease length of hospital stay or     emergency department visit.   "
64006|NCT02447861|"     The 3q29 deletion syndrome is caused by a deletion of a small part of human chromosome 3, and     the duplication syndrome is caused by a duplication of this same small region. The purpose of     this study is to understand the medical and behavioral consequences of these syndromes.   "
64007|NCT02447848|"     To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of     moderate-to-severe acute pain in patients in an emergency room (ER) setting.   "
64008|NCT02447835|"     Within the past 20 years, there has been a striking increase in the incidence of obesity 1;2,     type 2 diabetes mellitus (T2DM) 3-5, and cardiovascular diseases (CVD) in the schizophrenic     population 6-8 . Large NIH-funded trials indicate that the prevalence of metabolic syndrome     is twice to three times greater in schizophrenic patients on a specific class of drug termed     the atypical antipsychotics (AAPs), of which olanzapine is an example, as compared to     matched controls 8. Identification of the pathophysiological mechanisms contributing to     metabolic disease in schizophrenic patients on AAPs has been hampered by the inability to     differentiate underlying disease from treatment-emergent complications. In addition, despite     falling within the same drug class, different AAPs exhibit differential associations with     metabolic disease. Olanzapine is one of the AAPs associated with the greatest weight gain and     degree of metabolic impairments.   "
64009|NCT02447822|"     This is a prospective randomized controlled study to evaluate feasibility and safety of early     steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney     transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to     either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within     one week after kidney transplantation for all the patients. Maintenance immunosuppressants     are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of     biopsy-proven acute rejection, delayed graft function, graft loss or death within one year     post transplant.   "
64010|NCT02447809|"     Clopidogrel is an important anti-platelet agent.However, about 30% of the coronary artery     disease patients presented clopidogrel low response (CLR).Previous studies showed that the     cardiovascular event ratio of the CLR patients was 4.4 times of the normal responders.      It is known that the plasma and platelet miRNAs are determined by different disease status     when platelets are released from the megakaryocyte, and the platelet miRNAs can adjust the     expressions of the platelet's receptors and proteins.The purpose of this study is to find     multiple platelet miRNAs involved in the development of CLR, and platelet miRNAs cause CLR     through adjusting the expressions of the key receptors and proteins in the ADP activating     pathway and consequently reducing their responses to clopidogrel.      The CLR will be detected by light transmission aggregometry (LTA) and vasodilator-stimulated     phosphoprotein phosphorylation (VASP-P). Differential expressions of plasma and platelet     miRNAs profile in CLR patients will be screened by deep sequencing and validated to     investigate the association between plasma and platelet miRNAs profile and CLR as well as the     patients' prognosis.The study results would serve as markers for individualized anti-platelet     treatment, and supply new targets for the treatment of coronary artery disease.   "
64011|NCT02447796|"     The investigators designed a prospective randomized study to compare the conventionally used     sedative drug propofol with a latest alternative dexmedetomidine (DEX), in patients with     end-stage renal disease undergoing arteriovenous fistula (AVF) surgery.   "
64012|NCT02447783|"     Flavanols are plant-derived compounds commonly present in the human diet. Examples of     flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,     pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been     associated with improvements in cardiovascular health. In this study, the investigators hope     to learn more about the effects of long term consumptions of cocoa flavanols on blood     pressure, platelet function and other metabolic parameters in healthy humans. This study is a     continuation of a previous study investigating the consumptions of increasing amounts of     cocoa flavanols on blood pressure, platelet function and other metabolic parameters in     healthy humans   "
64013|NCT02447770|"     Flavanols are plant-derived compounds commonly present in the human diet. Examples of     flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,     pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been     associated with improvements in cardiovascular health. In this study, the investigators hope     to learn more about the effects of the consumption of increasing amounts of cocoa flavanols     on blood pressure, platelet function and other metabolic parameters in healthy humans. This     study was followed by a second study that aimed at investigating the effects of long term     consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic     parameters in healthy humans.   "
64014|NCT02447757|"     Retrospective observational study to determine the efficacy of remifentanil during the     delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100     parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia     induction) and parturients satisfaction with the method.   "
64015|NCT02447744|"     Childhood maltreatment is remarkably prevalent, and it has been shown to be associated with a     wide spectrum of mental health problems, and it also been shown to be associated with smaller     hippocampal volumes. This trial aims to see whether the 8-week mindfulness based stress     reduction intervention can reduce the symptoms of depression, anxiety and PTSD for young     adults with childhood maltreatment, and whether it can increase the hippocampal volumes.   "
64017|NCT02447718|"     This multi-center open label clinical trial aims to identify predictors of low antibody     titers to vaccine antigens in children with ALL who completed chemotherapy in the prior 6     months, and to determine the immunogenicity and safety of diphtheria-tetanus-acellular     pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) and     13-valent pneumococcal conjugate vaccine (PCV13) booster immunization administered 6 months     post-chemotherapy, followed by 23-valent pneumococcal polysaccharide vaccination (PPV23) 2     months later. The results will support the development of clinical practice guidelines for     this population.   "
64018|NCT02447705|"     Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be     reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular     filtration rate. This study is to see whether renal function is improved when Lamivudine is     replaced by telbivudine in liver transplantation patients.   "
64019|NCT02447692|"     For adult patients with acute respiratory failure requiring invasive mechanical ventilation,     does a ventilation strategy using proportional assist ventilation with load-adjustable gain     factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a     ventilation strategy using pressure support ventilation (PSV)?   "
64020|NCT02447679|"     This single-centered phase II clinical study is to obtain preliminary information on 1-year     recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in     combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore     biomarkers(VEGF/bFGF) for thalidomide response.   "
64021|NCT02447666|"     Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic     syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell     transplantation (HSCT).      Objectives Primary Objective The primary objective is to assess the treatment effect on     response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR;     JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle     3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a     matched-pairs analysis of historical data.      Secondary Objective The secondary objective is to further evaluate safety, efficacy,     pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population.      Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel     experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on     Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation     of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the     experimental arms will also individually be compared against a historical control arm using     data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS)     registry by means of a matched-pairs analysis; matched for predefined subject baseline     characteristics defined before any results from this study are known post Stage 1.      Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie,     subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at     approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at     the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a     CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then     enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR     after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be     stopped.   "
64022|NCT02447653|"     The study design comprises a randomized trial of patients undergoing primary total hip     arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular     plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning     will be used to measure periprosthetic bone mineral density. Clinical evaluations will be     conducted .   "
64023|NCT02447640|"     This is an open label study, non-randomized, positron emission tomography (PET)study     investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy     subjects using [18F]-FPEB as the radiotracer.   "
64024|NCT02447627|"     The purpose of the study is to determine whether imaging techniques, such as magnetic     resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging     (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in     different organ systems of participants with sickle cell disease (SCD). Differences in blood     flow and oxygen levels detected by these techniques will be evaluated to determine their     utility as biomarkers of clinical disease pathophysiology.   "
64025|NCT02447614|"     The study is designed to investigate the natural course of Primary snoring in 1-2 years or     more and the different effect of drug and surgical treatment applied in children with     obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires     in 6 months after treatment.   "
64026|NCT02447601|"     To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by     simvastation acid) in healthy subjects.      To assess the safety of single doses of simvastation administered with and without PEX168   "
64027|NCT02447588|"     Intrauterine insemination (IUI) combined with ovarian stimulation protocols has become one of     the first alternative treatment against infertility, although results in gestational terms     are highly variable, ranging between 10% and 25%. The influence of progesterone levels in     stimulated cycles of intrauterine insemination is an aspect little studied; however, this     information may be useful when synchronizing the time of insemination with the implantation     window, as it has been observed that patients with elevated levels of progesterone in the     follicular phase exhibit a significant decrease in ongoing pregnancy rates, these results     being possible due to premature ovulation which causes asynchrony between the embryo and the     endometrium.      Taking into account these considerations, the aim of the investigators' study is to determine     the effectiveness, in terms of ongoing pregnancy rates, to advance the intrauterine     insemination with sperm donor (24 hours post-hCG) with respect to the standard schedule (36     hours post-hCG) according progesterone levels determined the day of hCG administration   "
64028|NCT02447575|"     Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common devices     used to deliver medicine in conditions such as asthma and chronic obstructive pulmonary     disease. It is well-known that most patients do not use correct technique when using a     metered dose inhaler. This leads to poor control of their disease. This study is being done     so the investigators can record the patient using the metered dose inhaler before and after a     short teaching session. This information will be fed into an invitro system (device) to allow     the researchers to study the effect of error on drug delivery. The device being used is the     Rice R3 electronic flowmeter.   "
64054|NCT02447224|"     The major goal of the project is to demonstrate the feasibility of conducting a multi-center     randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of     patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as     to optimize the chance of a large multi-center clinical trial's future success.   "
64029|NCT02447562|"     Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a     health platform NOMHADchronic, phone-based care group, usual care group) developed in the     Valencia La Fe Health Department. 495 high-complexity chronic patients will be included     according to a combined recruitment based on a risk predictive model plus clinical opinion.     Patients will be followed-up during 12 months in order to evaluate health-related quality of     life, mortality, health consumption, health direct cost and treatment satisfaction.   "
64030|NCT02447549|"     Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed     in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the     bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually     treated either with surgical removal of the bladder, or daily radiotherapy treatment (high     strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate     methods which have the potential to improve how well this radiotherapy works.      RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single     UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout     treatment and treats the whole bladder with the same radiotherapy dose. In adaptive     radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused     radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the bladder.      In RAIDER, 240 participants with muscle invasive bladder cancer will be in one of 3 treatment     groups:        1. standard whole bladder radiotherapy        2. standard dose tumour focused adaptive radiotherapy        3. dose escalated tumour boost adaptive radiotherapy      Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after     radiotherapy and annually thereafter to check whether the cancer has returned and to receive     treatment for any symptoms they may be experiencing.      RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher     radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and     to check that the long term side effects of the treatment are acceptable. If this is the     case, results of RAIDER will be used to develop a study to establish whether dose escalated     radiotherapy is better at treating bladder cancer than standard dose.   "
64031|NCT02447536|"     The investigators aim to conduct a randomised controlled trial comparing two Bacille     Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in     terms of prevention of neonatal and early life morbidity and mortality, immune responses and     adverse events related to BCG vaccination. The primary outcome will be hospital admissions     within 6 weeks of age.   "
64032|NCT02447523|"     Worldwide, the rising incidence of obesity has led to the identification of an obesity     related syndrome, called metabolic. This syndrome is characterized by central obesity,     hypertension, insulin resistance and altered lipid levels.      Taking into consideration the rising incidence of obesity, anesthetists will more frequently     encounter patients with metabolic syndrome, in their everyday practice. Moreover, the     comorbidities that are related to the metabolic syndrome, increase the risk for perioperative     complications. Therefore, strategies that will evaluate and modify the risk will be of great     importance in the management of these patients, in order to maximize peri-anaesthetic and     surgical safety.      The aim of the study is to assess the incidence of metabolic syndrome and the impact of its     presence on the outcome of patients undergoing elective laparotomy.   "
64033|NCT02447510|"     Background: platelet concentrate could enhance growth factors (GF) crevicular fluid levels     which might be crucial to proper tissue repair and wound healing. However, the open usually     contaminated nature of periodontal defects could affect negatively GF availability and     activity. To test this assumption, this study was designed to evaluate levels of VEGF and     PDGF-BB in gingival crevicular fluid (GCF) during the early stages of healing of localized     intrabony defects treated with platelet rich in growth factor (PRGF) and platelet rich fibrin     (PRF) as compared with xenograft defect filling control.      Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this     prospective, randomized and single blinded trial. Each patient contributed one interproximal     defect that was randomly assigned to the bone substitute grafting control (n=10) G1,     experimental PRGF (n=10) G2 and PRF (n=10) G3. Plaque index, gingival index, probing depth     (PD), clinical attachment level (CAL) and the intrabony depth of the defect (IBD) were     measured at baseline for patient enrollment. Gingival crevicular fluid (GCF) samples were     collected on days 1 and 3, 7, 14, 21, and 30 days after therapy. The primary outcome variable     was the change in VEGF and PDGF-BB levels for sites treated by PRGF and PRF compared to that     of the xenograft treated cases.   "
64034|NCT02447497|"     The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of     the abdominal and inguinal regions of human subject.   "
64035|NCT02447484|"     The purpose of this study is to determine whether a program of regular, theory-based text     messages that encourages the message recipient to continue practicing safer sex (i.e., using     condoms with sex partners) is effective in maintaining positive behavior change in women who     have completed a brief safer-sex training.   "
64036|NCT02447471|"     Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm.     This can be set to inflate every minute, but measurement may fail due to patient movement or     shivering. Failed measurement occurs in up to 38% of patients.      This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped     around a finger - compares to standard BP measurement.   "
64037|NCT02447458|"     The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of     MLN3126 when administered as a single dose of tablets at escalating dose levels in healthy     participants.   "
64038|NCT02447445|"     Hand grip strength (GS) is a non-invasive marker of whole body skeletal muscle strength and     function used in research and recommended as a simple inexpensive measure suitable for     clinical use. Research has shown that low GS in hospital inpatients is associated with poor     healthcare outcomes including increased postoperative complications, longer length of stay,     increased functional limitations and disability. Measuring GS on admission to hospital has     the potential to identify people at risk of poor healthcare outcomes allowing early     intervention including focus on nutrition and mobility. Yet, GS measurement is not routinely     used in clinical practice. The aim of this study is to evaluate the implementation of GS     measurement into routine clinical practice in Medicine for Older People wards at UHS.   "
64067|NCT02447055|"     The purpose of this study is to develop a novel platform for allo-SCT in multiple myeloma     (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD     (graft versus host disease). Specifically, the investigators will use the Flu/Mel     (fludarabine and melphalan) regimen. For GvHD prophylaxis, the investigators use the Hopkins     PT-Cy (post-transplant cyclophosphamide) platform with the novelty of adding tocilizumab as     both an anti-myeloma therapy and as a method to reduce GvHD. IL-6 has an important role in     promoting the growth of myeloma cells and progression of disease.   "
98484|NCT01997086|"     The purpose of this study is to evaluate the effectiveness of two minimal invasive endoscopic     discectomy, PTED and MED, for the treatment of symptomatic lumbar disc herniation.   "
64039|NCT02447432|"     The primary aim of the study is to demonstrate that an investigational 4-dose presentation of     the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of     Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal     serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first     secondary objective), after administration of a 3-dose primary vaccination course at 6, 10     and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at     6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).      In addition, the study will also assess the safety, reactogenicity, immunogenicity and     antibody persistence (approximately 7 months following primary vaccination) of the 4-dose     presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18     weeks of age followed by a booster dose at 38 weeks.      This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose     presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9     months of age.   "
64040|NCT02447419|"     This study is a single-arm,phase II study of gefitinib in patient with epidermal growth     factor receptor amplification Refractory solid tumors.      Gefitinib 250 mg will be administered orally daily.      To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor     receptor amplification Refractory solid tumors.   "
64041|NCT02447406|"     Phase Ib/II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in     advanced gastric adenocarcinoma patients with MET amplification as a second-line treatment.      Phase Ib:Investigational product, dosage and mode of administration Volitinib is an orally     available, potent, selective, small molecule c-MET inhibitor.      Volitinib should be administered at least 200mg orally once a day in 21 days for achieving     appropriate antitumor activity.      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks Phase II:     Investigational product, dosage and mode of administration Volitinib is an orally available,     potent, selective, small molecule c-MET inhibitor. Subjects will receive Volitinib once daily     ( at the MTD determined from Phase Ib) for 21 days as one cycle.      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.   "
64042|NCT02447393|"     This is a single center, single blind, single dose, randomized, partial cross-over study to     confirm bioequivalence between levocetirizine and cetirizine.   "
64043|NCT02447380|"     Phase II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in advanced     gastric adenocarcinoma patients with MET overexpression as a second-line treatment.      Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor.      Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days     as one cycle.      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.      To investigate the efficacy of volitinib when given in combination with docetaxel in patients     with advanced gastric adenocarcinoma harboring MET overexpression.   "
64044|NCT02447367|"     The purpose of this study is to investigate the pharmacokinetic drug interaction between     Solifenacin and Tamsulosin in healthy male volunteers.   "
64045|NCT02447341|"     This is a national, multicenter, cross-sectional, observational study within a convenience     sample of Internal Medicine departments from 100 hospitals in Spain which agree to     participate in the study. This study will be a cross-sectional chart review which will     require the collection of data from medical records and from face-to-face interviews     conducted during the inclusion visit. Physician interviews are needed to collect three     variables of interest, recommended by the Spanish Society of Internal Medicine as necessary     data about profile and management of NVAF patients: cognitive deterioration based on the     patient's responses, physician's assessment of the patient's life expectancy, and physician's     opinion of the antithrombotic treatment previously prescribed. The investigators will only     provide their opinion on previously prescribed therapies (i.e. prescribed before F2F).     Hospitals to be contacted for the study include those known to participate in observational     studies in Spain; the hospitals will therefore not be a random sample of Spanish hospitals.   "
64046|NCT02447328|"     This single-arm study aims to assess the safety and tolerability profile of     Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally     advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events     after Fulvestrant (Faslodex®) for about 6 months   "
64047|NCT02447315|"     The purpose of this study is to evaluate the pharmacodynamic effect of oral doses of     pilocarpine on salivary secretion in healthy male and female subjects. In addition,     pharmacodynamic effect on static pupillometry will be evaluated as well as pharmacokinetics     and safety and tolerability of oral doses of pilocarpine in healthy subjects.   "
64048|NCT02447302|"     The purpose of this study is to determine whether APD334 is a safe and effective treatment     for ulcerative colitis.   "
64049|NCT02447289|"     Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives;     masked, controlled, parallel design with three arms, phase 4.   "
64050|NCT02447276|"     The primary objective of this study is to evaluate the effectiveness of REGN475 compared to     placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history     of inadequate joint pain relief or intolerance to current analgesic therapy.   "
64051|NCT02447263|"     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional     therapy using digital subtraction angiography（DSA） for liver cancer.   "
64052|NCT02447250|"     The purpose of this study is to help determine the best dose of albuterol in premature babies     at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of     prematurity and is associated with increased morbidity and mortality, longer hospital stays,     and increased healthcare utilization. Albuterol is an inhaled medication frequently used in     premature infants with chronic lung disease and in people with asthma. It is believed to be     safe, but the optimal dose for infants is not clear. The investigators hypothesize that     albuterol may help a subset of premature infants with lung disease, but they need to     determine the best dose prior to doing research about how effective it is for chronic lung     disease/BPD. Response to each of three doses of albuterol will be measure using pulmonary     function tests.   "
64053|NCT02447237|"     The study investigates the effect of liquid food on the intake of energy and protein compared     to solid food. One group will receive dietary counselling in fulfilling their need for energy     and protein from liquid food and the other group from solid food.   "
64055|NCT02447211|"     Radiation dermatitis is one of the most common side effects of radiotherapy approximately     occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural     tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear     and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis     occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and     discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities     such as radiation dermatitis encountered in clinical practice are typically managed with a     variety of topical agents such as water-based moisturizing creams or lotions, topical     steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for     the prevention and treatment of these toxicity can be used to protect skin against radiation     damage.Currently, there is no standard treatment for the prevention of radiation-induced     dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind,     placebo-controlled study is to evaluate the effectiveness of topical doxepin for the     prevention and management of radiation-induced dermatitis during postoperative radiotherapy     for breast cancer.   "
64056|NCT02447198|"     Legislation to allow medical marijuana has had a significant impact on the pediatric     population of Colorado. There have been many reported different effects and properties of     each of the over 60 known cannabinoids found in marijuana. The main exposures in pediatrics     have involved the use of Cannabidiol (CBD) high- and Tetrahydrocannibinol (THC) low-content     hash oil in children with epilepsy. The reported benefit of this oil is to have the     anticonvulsant properties of CBD without the psychoactive components of THC. Human studies on     the efficacy of CBD on epilepsy are few and limited.      The investigators' specific aims are the following:        -  Specific Aim 1: Describe the plasma pharmacokinetics of Cannabidiol (CBD),          Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with          epilepsy.        -  Specific Aim 2: Describe the plasma pharmacokinetics of other antiepileptic drugs (AEDs)          taken in conjunction with CBD in order to evaluate drug interactions.        -  Specific Aim 3: Describe parental perception of efficacy of CBD on control of epilepsy.      The investigators will recruit children and their parents who are currently using or plan to     use CBD for their seizure disorder. This study will NOT be providing patients with CBD.     Consenting subjects will undergo a number of blood and urine collection that will be analyzed     to describe the pharmacokinetics and possible drug interactions of CBD in pediatric epilepsy.   "
64057|NCT02447185|"     Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic     patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth     factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.   "
64058|NCT02447172|"     This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel     cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized     to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with     either (A) daily application of a gentamicin-sponge, (B) daily application of a     placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for     approximately 28 days and return to the clinic weekly for safety and efficacy assessments.     After completing treatment, patients will return to the clinic for scheduled follow-up visits     approximately 10, 30, 60 and 90 days after treatment is stopped.   "
64059|NCT02447159|"     A randomized controlled trial will be conducted to assess the effectiveness of conditional     cash transfers (CCTs) at increasing retention in prevention of mother-to-child transmission     (PMTCT) services specifically, in relation to pickup of ARV drugs for infected mothers,     delivery in the hospital setting, and receipt of drugs for exposed infants. Administrative     data will be extracted from the All Babies are Equal program and hospital records. At 8-10     weeks after delivery, an endline survey will also be conducted with each participant to     provide a deeper understanding of the impact of the CCTs and to assess the reasons for     retention in PMTCT services.   "
64060|NCT02447146|"     This is a controlled trial to assess the effects of resistance training on bradykinesia and     physical function in patients with Parkinson's Disease. Forty patients diagnosed with     Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were     allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the     Control Group attended lectures on the disease.   "
64061|NCT02447133|"     The objective of this study is to validate the TopQ cutoff scores, which have been previously     determined.   "
64062|NCT02447120|"     The objective of this study is to collect OCT measurement data on normal healthy eyes in     order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile     points for 1%, 5%, 95%, and 99%.   "
64063|NCT02447107|"     Mobile technology can be used to passively capture data tracing features and fluctuations of     patients' daily activities, including activity levels, location patterns, sleep, and a wide     variety of other health-relevant metrics. This data can then be combined with contextual     recall, collected through a mobile app, to enhance passively captured behavioral data. The     resulting data collection is objective, real-time, and contextual, thus addressing the     pitfalls of conventional measurement of pain treatment outcomes.   "
64064|NCT02447094|"     To study the effect of a telemedicine model of stroke care on patient-based outcomes.   "
64065|NCT02447081|"     This will be a prospective, multicenter, observational, non-randomized study to compile real     world outcome data on the use of the Amulet™device in non-valvular atrial fibrillation (NVAF)     subjects. The study is designed to follow the Instructions For Use (IFU) to gather data on     the implant procedure through two years of follow up with the Amulet™ device in a commercial     clinical setting.   "
64066|NCT02447068|"     This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of     a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive     dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms     will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to     the light alone and to dressing alone and no treatment. Ten patients will be enrolled in this     6 weeks study.   "
64310|NCT02443896|"     The purpose of thus study is to assess the feasibility and inform the planning of a proposed     definitive randomised controlled clinical trial to investigate the efficacy of sealing     permanent molars in children requiring caries related extractions under a chair General     Anaesthetic.   "
64068|NCT02447042|"     The administration of fluids intravenously is the first step in the stabilization of patients     in septic shock. It is important to give the right dose of fluids, enough to improve the     function of the cardiovascular system but not too much to drown the cells in water. In order     to know that, the investigators use the fluid challenge which is the administration of a     small amount of fluid in a short period of time in order to test the cardiovascular     response to a dose of fluids. However, it is unclear how small this amount can be. The aim     of this study is to find out the minimum volume required to perform an effective fluid     challenge. The investigators hypothesize that the changes in the mean pressure in the     cardiovascular system (socalled mean systemic filling pressure or Pmsf) during the     administration of small amounts of fluid can be used to detect the minimum volume required to     effectively test the cardiovascular system with a fluid challenge.      On the other hand, microcirculation may remain impaired despite the stabilization of the     macrocirculation. The microcirculation can be much more dynamic than the macrocriculation, so     it is essential to observe the changes of both over time. Patients admitted at the     investigators' intensive care unit (ICU) due to sepsis can be included in this study. The     sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg, 3     ml/kg, 4ml/Kg and 5 ml/kg.      The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated     during one minute. Invasive arterial blood pressure will be observed during the inflation of     the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this     method is 14%. The minimal volume will be that one that achieve that change in Pmsf.   "
64069|NCT02447029|"     Despite global efforts to decrease discomfort during surgical abortion, pain remains a     limiting factor in where and how procedures are performed. Several studies have investigated     different methods of delivering cervical anesthesia prior to abortion, however to the best of     the investigators' knowledge, there is no published data that 1) rigorously examines the     effect of a time interval between local anesthetic administration and procedure initiation,     or 2) explores whether adequate pain relief is possible through self-administered,     non-invasive means alone. Research in this area has a significant public health impact, given     the large number of women worldwide who seek abortions.      The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in     place of the traditional paracervical block prior to first trimester surgical abortion. They     hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion     related pain at a variety of time points throughout the procedure. This is a non-inferiority,     open label, randomized controlled trial.      If self-administered vaginal gel is acceptable and effective, it would increase options for     pain control during abortion and other gynecologic procedures.   "
64070|NCT02447016|"     The aim of this prospective, open label study is to check for differences in neuropsychiatric     and neurocognitive measurements among patients that will be switched from Atripla to Eviplera     among 40 patients.   "
64071|NCT02447003|"     This is a two-part study of pembrolizumab monotherapy in participants with metastatic     triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and     safety of pembrolizumab monotherapy as first line or above treatment. Part 2 of the study, if     done, will expand the investigation of pembrolizumab treatment in a subgroup of participants     from Part 1 and will only start after enrollment in Part 1 has been completed.   "
64072|NCT02446990|"     The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in     patients with coronary artery disease.   "
64073|NCT02446977|"     Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to     know if it causes a reduction of glutamate-mediated excitotoxicity.   "
64074|NCT02446964|"     This phase I trial studies the side effects and best dose of total bone marrow and lymphoid     irradiation when given together with chemotherapy before donor stem cell transplant in     treating patients with myelodysplastic syndrome or acute leukemia. Total marrow and lymphoid     irradiation is a type of radiation therapy that targets bone marrow and blood, where the     cancer is, instead of applying radiation to the whole body. Stem cell transplants use high     doses of chemotherapy and radiation therapy, such as total marrow and lymphoid irradiation,     to kill cancer cells, but these treatments kill normal cells as well. After chemotherapy,     healthy cells from a donor are given to the patient to help the patient grow new blood cells.   "
64075|NCT02446951|"     Jaundice is a condition caused by elevated levels of bilirubin in the body otherwise known as     hyperbilirubinemia. It occurs when there is an increase in bilirubin production or normal     production with problems eliminating it from the body. Serum levels of bilirubin in excess of     5 mg/dL signifies clinical jaundice, yet more than half of full term infants experience these     levels within the first week of life. For those patients who have markedly elevated serum     bilirubin levels, which phototherapy cannot sufficiently treat, the use of exchange     transfusions is a viable option within the hospital setting. In comparison, bili-blankets     have been used as a form of phototherapy for those patients being treated in a home-based     setting to reduce the likelihood of hospital readmissions.   "
64076|NCT02446938|"     Transpulmonary pressure is frequently monitored in patients with mechanical ventilation.     Right position of the catheter balloon is the key factor in accurate measurement. A simple     method for confirming the balloon position will be validate in this study.   "
64077|NCT02446925|"     The Surefire Infusion System is a novel catheter initially developed to prevent reflux of     embolic material into non-target vascular territories. Further research has demonstrated     improved penetration and distribution of embolic material into treated arterial territories.     The purpose of this study is to compare Y-90 glass microsphere distribution and penetration     into cancerous tissue within the liver between a standard endhole catheter and the Surefire     Infusion System.   "
64078|NCT02446912|"     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment     regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to     severely active, autoantibody-positive systemic lupus erythematosus (SLE).   "
64079|NCT02446899|"     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment     regimen of anifrolumab versus placebo in adult subjects with moderately to severely active,     autoantibody-positive systemic lupus erythematosus (SLE).   "
64311|NCT02443883|"     The main purpose of this study is to evaluate the safety and feasibility of administering     higher doses of ramucirumab in participants with gastric cancer.   "
64080|NCT02446886|"     The primary objective of this study is to determine if monthly pulse doses of a three-day     course ACTH (H.P. Acthar®) is more effective at recovering myelin at 12 months, as measured     by myelin water fraction (MWF), in new multiple sclerosis lesions as compared to one course     of treatment.      The main secondary objective is to utilize every three month MWF measurements to determine     the peak time of remyelination in new multiple sclerosis lesions when followed over the     course of 12 months.   "
64081|NCT02446873|"     The proposed study will fill an important gap in the literature by examining, through a     randomized controlled trial, the effect of egg consumption on biochemical markers of choline,     vitamin B-12, lipids, and amino acids in young children in a poor rural area of Ecuador.     Children from Cotopaxi Province, Ecuador (n=180) will be randomized into one of two groups:     1) intervention, receiving one egg per day for six months; or 2) control. Baseline and     endline data on socio-economic factors, and child diet, morbidities, and anthropometry will     be collected. Blood will also be drawn from the children at these time points for nutrient     biomarker analyses. Through qualitative research the proposed study will provide insight into     the attitudes, beliefs, and use of eggs by mothers and other caregivers during the     complementary feeding period. The University of San Francisco in Quito (USFQ) will be the     lead field coordinator of the research working in partnership with Washington University in     St. Louis, Pan-American Health Organization (PAHO) and University of California, Davis.   "
64082|NCT02446860|"     Single arm, open label, phase II trial. Participants to undergo biopsy of primary tumour     followed by 8 weeks of nivolumab therapy followed by nephrectomy. Nivolumab to be continued     post-operatively   "
64083|NCT02446847|"     This study evaluates the effects of two infusions of 3BNC117 in preventing or delaying     rebound of viral load during a brief treatment interruption of standard ART and its safety     during a brief analytical interruption of antiretroviral therapy.   "
64084|NCT02446834|"     Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor     Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their     metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism     of intensive lifestyle intervention to PCOS.   "
64085|NCT02446821|"     Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the     effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a     Phase III Clinical Study   "
64086|NCT02446808|"     The purpose of this study is to determine whether the use of intraoperative nerve monitoring     during robotic-assisted laparoscopic prostatectomy surgery improves post-surgery urinary     continence and erectile function.   "
64087|NCT02446795|"     Advanced renal cell carcinoma is invariably fatal, with a life expectancy of 2-3 years since     diagnosis. Sunitinib is the standard first-line treatment for this condition, but it is     associated to multiple side effects, with fatigue being reported in 51-63% of patients. As     sunitinib-induced fatigue is likely to be mediated by inhibition of AMPk function, the     investigators hypothesize that isoquercetin, which is hydrolyzed in vivo to quercetin, a     known AMPk activator, is able to reduce fatigue in kidney cancer patients taking sunitinib.   "
64088|NCT02446782|"     This is a prospective study to assess the efficacy and safety of a single dose of cefazolin     2g IV for the prophylaxis of surgical site and pleural space infections in patients     undergoing medical thoracoscopy.   "
64089|NCT02446769|"     This is a multicenter, randomized, parallel-group, open label study of the efficacy of     AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD.   "
64090|NCT02446756|"     To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on     cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two     random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was     used to evaluate the motor function of knee joints, followed by magnetic resonance imaging     (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.   "
64091|NCT02446743|"     The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after     the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in     adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10     (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with     rMenB+OMV NZ   "
64092|NCT02446730|"     The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD)     of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous     coronary intervention (PCI) with BiomatrixTM stent.   "
64093|NCT02446717|"     The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or     without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who     previously failed treatment with a direct acting antiviral (DAA)-containing regimen.   "
64094|NCT02446704|"     This research study is evaluating the combination of olaparib and temozolomide as a possible     treatment for Small Cell Lung Cancer.   "
64095|NCT02446691|"     This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will     be provided information about the trial. If interested and if eligible, they will then be     asked to provide signed informed consent. The initial study visit can occur immediately after     signed informed consent has been obtained. Approximately 135 subjects will be enrolled to     receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.   "
64103|NCT02446587|"     SELECT is a multicenter, observational prospective study implementing a protocol to acquire     imaging and clinical variables known to affect clinical outcomes after endovascular therapy     in an effort to evaluate and compare the different selection methods and criteria currently     used in practice for acute ischemic stroke patients in the anterior circulation with large     vessel occlusion. The study aim is to evaluate prospectively different selection     methodologies for endovascular therapy, to compare them against each other to identify which     method provides the highest predictive ability in the selection of patients for IAT and to     devise a formula that predicts patients' outcomes.      This study will enroll patients based on the recent AHA guidelines (July 2015) regarding     treatment of patients with acute ischemic strokes and large artery occlusions in the anterior     circulation.   "
64104|NCT02446574|"     This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with     radiation therapy, and to document the adverse events for further clinical trial.   "
64096|NCT02446678|"     Background        -  Patients presented to hospital with coffee ground vomiting and black stool may not be          actually having upper gastrointestinal bleeding (UGIB)        -  Hospital admission can be avoided if serious UGIB can be excluded        -  To date, the only useful tool to triage patient for hospital admission in UGIB is by          using clinical score such as Rockall score or Blatchford score        -  These scores are cumbersome and only exclude the most benign cases, but they are not          useful in differentiating those who needs intervention        -  In our pilot study, investigators found that capsule endoscopy can be used to identify          patients with fresh blood and real coffee ground substance in the stomach and it is          superior to nasogastric tube        -  Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy      Objectives The current study is designed        1. to validate capsule endoscopy is an effective method in identifying patients with UGIB        2. to study whether the capsule endoscopy can reduce requirement of hospital admission in          patients with suspected UGIB        3. to study if capsule endoscopy can help to identify patients with UGIB that may require          urgent (within 24 hours) endoscopy and intervention        4. to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in          the management of UGIB        5. to compare the effectiveness of capsule endoscopy against Blatchford score in          identifying patients with UGIB that may require endoscopic intervention.   "
64097|NCT02446665|"     Primary sclerosing cholangitis (PSC) is a chronic liver disease that can lead to liver     cirrhosis, liver failure and liver cancer. Assessment of disease status is important to     determine optimal treatment but the diagnosis of PSC is challenging. There is a dire need of     an accurate non-invasive tool for longitudinal assessment of PSC. MR Elastography (MRE) has     been recently proven to estimate liver fibrosis noninvasively and accurately. Estimation of     liver fibrosis by MRE along with imaging derived morphological information (MRCP) will be     utilized in this study comprehensively to provide a surrogate non-invasive imaging biomarker     for monitoring disease status in PSC. Successful outcomes will provide an opportunity for     optimal treatment triage including liver transplantation via accurate and non-invasive     estimation of true disease status in PSC.   "
64098|NCT02446652|"     The purpose of this study is to determine the efficacy and safety the combination of     TRANSKRIP ® vs placebo plus Carboplatin/Paclitaxel as first line treatment in patients with     recurrent-persistent cervical cancer.   "
64099|NCT02446639|"     Troponin T (TnT) is a component of the contractile apparatus of the striated musculature.     Although the function of TnT is the same in all striated muscles found in the heart to form a     TNT (cardiac TnT) differing significantly TnT of the skeletal muscles. Because of its high     tissue specificity, cardiac TnT is a specific marker and highly sensitive of myocardial     injury.      Asymptomatic elevations of troponins is frequently found in patients with chronic renal     failure in stage V, which present no clinical signs of acute or electrical myocardial injury.      Many studies have been conducted in recent years to explain the origin and clinical     significance of this elevation, but the results are controversial: cardiac dysfunction, left     ventricular hypertrophy or chronic inflammation.      Besides the effect of the dialysis session was evaluated on this biological parameter in     different studies which together do not find Impact hemodialysis session on the value of     troponin Achieving dosages rate hypersensitive serum troponin T in a dialysis population,     will:        -  to determine the evolution of TnT in time and what are the characteristics of the          patients for whom this rate varies        -  to know what its evolution during the session,        -  to identify if possible the criteria that are responsible for the variation in the          direction of increasing and / or its reduction        -  and to characterize patients whose base rate is higher than the 99 percentile in the          absence of clinical symptoms which could lead to establish reference population for this          specific normal values. The Purpose of this study is to evaluate the serum troponin T in          a hypersensitive dialysis population and verify what is the influence of the          hemodialysis session, the session parameters and intradialytic events on changes in          serum troponin T hypersensitive after a hemodialysis session.    "
64100|NCT02446626|"     Background:      The most common tick-borne illness in the United States, Lyme disease is caused by Borrelia     burgdorferi bacteria that are transmitted to people by Ixodes scapularis ticks. Most cases of     Lyme disease are cured by antibiotics, but some patients continue to experience symptoms     despite the absence of detectable Lyme bacteria. Xenodiagnosis uses a vector to detect the     presence of a disease-causing microbe.. Researchers will use live, laboratory-bred ticks to     see if Lyme disease bacteria can be detected in people after completing antibiotic therapy     and if that is more common in people who continue to experience symptoms such as fatigue and     joint pain.      <TAB>      Objectives:      - To see if ticks can be used to detect B. burgdorferi in people who have had Lyme disease     and received antibiotic therapy and if it correlates with persistent symptoms.      Eligibility:        -  Adults at least 18 years old who have:        -  Untreated erythema migrans (the Lyme disease rash); OR        -  Untreated Lyme arthritis; OR        -  Continuing symptoms after treatment for Lyme disease; OR        -  Had Lyme disease and antibiotic treatment within the past 12 months.        -  Healthy volunteers      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Visit 1:        -  Blood and urine tests, health questionnaire.        -  Up to 30 laboratory-bred, pathogen-free, larval ticks (each smaller than a poppy seed)          will be placed under a dressing.        -  Participants may have two small biopsies of skin .        -  4 6 days later, Visit 2:        -  Dressing will be removed and ticks will be collected.        -  Participants will answer symptom questions.        -  If many ticks are still attached, participants will have to come back the next day. If          not enough ticks feed successfully, the procedure may be repeated.        -  Participants will keep a diary of symptoms for 30 days. Over 3 months, they will be          return to the clinic 3 times to see how they feel and answer questionnaires. Test          results will be discussed.   "
64101|NCT02446613|"     This study will evaluate the duration of effect of GSK2245035 on allergic reactivity by     repeating a nasal allergen challenge (NAC) approximately one year after treatment in subjects     from TL7116958. This is a single centre, single period study in subjects with respiratory     allergy/allergies who completed the study TL7116958 in 2014 to investigate the long term     effect of previous treatment with GSK2245035 compared with placebo on total nasal symptoms     elicited by nasal allergen challenge. Subjects and staff will remain blinded to the treatment     received in the TL7116958 study (GSK2245035 or placebo). The study will consist of a     screening visit to assess eligibility criteria, a study period consisting of a single visit     when the nasal allergen challenge will be performed, and follow up by phone or a clinic visit     at the discretion of the investigator 4-7 days following the allergen challenge. Eligible     subjects will participate in this study for approximately70 days total from screening to     follow up.   "
64106|NCT02446548|"     The study is a randomised, double-blind, controlled 2 x 3 cross-over trial in which the renal     effects of therapy with aliskiren (A), placebo (P) and losartan (L) will be compared. It     consists of an 8-week run-in period, 8 weeks of active treatment with aliskiren or losartan     (period 1), 8 weeks of active treatment with the alternative medication (period 2), and an     8-week placebo administration between them.   "
64115|NCT02446431|"     Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and     complete treatment in remission. High-risk patients however, frequently have recurrent     disease which is then treated with ad hoc regimens or early phase therapies with little     benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug     exposure, has been successfully tested in pediatric leukemias with excellent results in terms     of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors with     little success, but has been implemented usually in the relapsed setting at a time of high     tumor burden and disease resistance.   "
64107|NCT02446535|"     Background Very recently, a test aimed at assessing dry weight (DW) in hemodialysis (HD)     patients has been developed, the resistance stabilization test (REST)      Aim of the study To verify if BIA-based DW (BIA DW) control is truly superior to current     volume management in HD patients.      Protocol of the study DW determined with clinical methods (Clinical DW) is the gold standard     by definition: Clinical DW is determined under strict clinical surveillance by the same     attending physician. He will be helped by a clinical score of volume state about symptoms and     signs of hypo- or hypervolemia. The physician is asked to adjust the DW of the candidates     until their clinical score reaches zero before the BIA measurement. This Clinical DW will be     compared with BIA DW, as obtained after performing REST      Phases of the study      The protocol study includes three sequential phases:        1. the Clinical DW is the gold standard by definition. Items of form B must be strictly          applied until score = 0 is achieved;        2. The Clinical DW as indicated by the score = 0 becomes the target DW of the next standard          HD session, in which BIA measurements are performed: R values are recorded continuously          during the session.        3. REST is performed the following dialysis session. As per protocol, these dialysis          sessions may be one or more than one, until flattening of the curve of the ratio R0/Rt          (R0 is R at time 0 and Rt is R at a given time t during the HD session) of less than +          1% over 20 minutes in the presence of ongoing UF, is obtained.      Primary outcome      The primary outcome is the definition for each patient of the gold standard DW when comparing     the Clinical and the BIA DW. Two are the possible scenarios:        1. the Clinical and the BIA DW will be very similar ( < + 0.5 kg). Therefore, a reciprocal          validation of the two methods for that specific patient has been obtained;        2. the Clinical and the BIA DW are different ( > + 0.5 kg). If the BIA DW will be confirmed          in the following six dialysis sessions, it means that the gold standard DW for that          patient is the BIA DW.   "
64108|NCT02446522|"     There is no shared vision relating to integrity and quality of the conduit after the impact     on the vein wall during vein harvesting. In this connection, the investigators studied the     initial state of the venous conduit, interoperation damages of the vein and postoperative     wound complications while using two methods of GSV harvesting.   "
64109|NCT02446509|"     Bipolar disorder is a debilitating chronic illness characterized by periods of elation and     depression. Since deinstitutionalization of the mentally ill over 40 years ago, families have     become major caregivers for patients with bipolar disorder . This illness imposes a     substantial and chronic burden on family caregivers Despite their persistent stress and     burden, these caregivers have been largely ignored. Interventions to help them have been very     limited. One comprehensive intervention was developed and implemented by Miklowitz (2008) and     has shown to be effective in reducing caregiver depression and improving health outcomes.     However, this intervention and is highly complex, long, and was given on an individual basis,     significantly raising the cost of the program. One core component of the Miklowitz (2008)     intervention is psychoeducation, which provides the fundamental support and information     needed to caregivers on an individual basis.      In this pilot study, the intervention group will receive 7 weekly psychoeducation sessions.     After completion of these sessions in the intervention group, the wait list control group     will receive the same weekly sessions. In this study, the investigators plan to test the     feasibility and potential efficacy of this specific psychoeducation intervention implemented     in a group setting. The investigators will also examine the effects of this psychosocial     intervention on biological mechanisms (cortisol and inflammatory biomarkers) and health     outcomes.      The specific aims are to:        1. Test the feasibility of implementing a 7-week group psychoeducation program for family          caregivers of patients with bipolar disorder by assessing recruitment and retention          rates, attendance, satisfaction with the program, and data and sample collection rate.        2. Explore the effect of the intervention on caregiver outcomes (depression, burden, health          status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.      The intervention will be delivered by at the University of Texas Health Science Center at     Houston Center of Excellence for Mood Disorders (CEMD) and at the University of Texas Health     Science Center at Houston School of Nursing. Forty family caregivers of patients with bipolar     disorder will be recruited into the study.   "
64110|NCT02446496|"     This is an open-label, randomized, single dose, two-sequence two-period crossover study,     separated by 7 days washout interval from the first Study Drug Administration. This study is     conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets     manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and     cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &amp;Chem .Ind.     Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy     adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive     cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days,     subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not     receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a     trademark of Sandoz.   "
64111|NCT02446483|"     This is an open-label, randomized, single dose, two-sequence, two-period crossover study,     separated by 7 days washout interval from the first study drug administration.      In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed     release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of     each to healthy adults under fasting conditions, will be investigated by determining the 90%     confidence limits for the log-transformed ratio (Test product / Reference product) for the     bioequivalence parameters. The influence of sequence, product and period effect will be     tested by analysis of variance (ANOVA).      In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split     into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will     be done and the volume of blood will not exceed 300 milliliters (mL) for the study.      PARIET is a registered trademark of EISAI Co. Limited.   "
64112|NCT02446470|"     This study is a prospective, randomized controlled trial comparing the sinus tarsi approach     to the extensile lateral approach for surgical fixation of calcaneus fractures.      It is hypothesized that open reduction and internal fixation of intra-articular calcaneus     fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable     fixation with significantly decreased wound complication rates in comparison to an extensile     lateral approach.   "
64113|NCT02446457|"     The goal of this clinical research study is to learn if the combination of pembrolizumab and     rituximab can help to control relapsed follicular lymphoma (FL), and if the combination of     pembrolizumab, rituximab, and lenalidomide can help to control relapsed FL or diffuse large     B-cell lymphoma (DLBCL). The safety of both combinations will also be studied.   "
64114|NCT02446444|"     The purpose of this study is to determine the effectiveness of enzalutamide as part of     adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone     analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk     of recurrence.   "
64152|NCT02445950|"     The purpose of this study is to examine whether the technology (web-based coaching, profiling     and suggestion tool) brings added value to the traditional phone coaching in occupational     health context. The interventions are phone counseling interventions. The other intervention     exploits additionally a specific web-based coaching, profiling and suggestion tool.   "
70634|NCT02361216|"     The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for     actinic keratosis applied to large treatment areas once daily for three consecutive days on     face, scalp or chest.   "
64335|NCT02443571|"     This retrospective observational multi centered study has been established to collect the     clinical experience relating to the administration of Fluciclovine 18F employed in both     investigator initiated studies and named patient/compassionate use programmes in up to 5     sites.   "
64116|NCT02446418|"     The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a     once-daily combination therapy for the long-term maintenance treatment of asthma in adults     and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and     efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised     clinical trials tend to be highly controlled and enrol a more highly selected subject     population than is expected to be prescribed the medication post-approval. There is a need     for data in a more representative population in close to a 'real life' conditions, where     physicians have the ability to choose the best treatment in their view for any individual     subject and adapt treatments to subjects' characteristics and response. This multi-center,     open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI     compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S]     or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a close to real     life settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler     (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™     DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total     duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and     DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered     trademark of AstraZeneca.   "
64117|NCT02446405|"     The purpose of this study is to determine the effectiveness of enzalutamide, versus a     conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone     releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation     therapy (ADT) for newly diagnosed metastatic prostate cancer.   "
64118|NCT02446392|"     In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are     included with the aim to investigate the potential underdosing in this patient group. Four     regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before     the next dose is administered for three consecutive days.   "
64119|NCT02446379|"     This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in     detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.      EnLightTM will be used to detect positron emission and the LightPathTM system to detect     Cerenkov Luminescence. Both are emitted by the Positron Emission Tomography (PET) agent.      The study will also evaluate the patient safety and radiation safety of the EnLightTM, and     the safety for the device operators and surgical staff of the LightPathTM Imaging System.   "
64120|NCT02446366|"     This phase I trial studies the side effects and the best dose of hypofractionated     stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was     removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a     shorter period of time and may kill more tumor cells and may have fewer side effects than     standard radiation therapy.   "
64121|NCT02446353|"     A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and     Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.   "
64122|NCT02446340|"     The purpose of this study is to examine safety outcomes in healthy volunteers after systemic     administration of multiple ascending doses of dalazatide.   "
64123|NCT02446327|"     The main objective is to replicate the validation of omics biomarkers of left ventricular     diastolic dysfunction in patients with metabolic syndrome.      The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625     patients were enrolled in Europe and 47 in France.   "
64124|NCT02446314|"     The purpose of this study is to determine whether a 6 month dietary intervention with wild     blueberry powder and extract stabilised with L-cysteine and L-glutathione have an effect on     cognitive performance in participants aged between 65 - 80.   "
64125|NCT02446301|"     This study is to evaluate the relative bioavailability of nalbuphine after single IM     injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM     injection in healthy volunteers.   "
64126|NCT02446288|"     The study is an open-label, prospective, multicenter, randomized, two treatment parallel,     comparison study of the TMJ NextGeneration and DSG Relaxer in the reduction of nocturnal     bruxism episodes in subjects diagnosed with sleep bruxism.   "
64127|NCT02446275|"     Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory     manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points     (MTrPs) and their stretching, often being hypersensitive in patients with migraine.      Material and methods: 27 patients in two groups participated in the study: a) the control     group received combined techniques based on MTrPs and bilateral stretching in the trapezius     and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same     techniques as those applied in the control group plus suboccipital inhibition. The treatment     lasted for 8 weeks and the impact, disability and quality of life were assessed in both     groups.   "
64168|NCT02445742|"     Prospective, open label, multicenter, phase II study evaluating correlation of SNPs with     efficacy and toxicity in patients treated with Bosutinib. A total of 50 patients with     previously treated Ph+ chronic phase CML will be included in the study   "
64169|NCT02445729|"     The purpose of this study is to determine if surgical dressings removed at 24 hours or 48     hours improves wound healing and appearance, and to determine if surgical dressings removed     after 24 hours or 48 hours decreases the incidence of post-operative wound infections.   "
64170|NCT02445716|"     This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75     years, with treatment-emergent loss of libido will be randomly allocated to the treatment     with a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg of     testosterone/day or an identical placebo nanoemulsion (PLA) for 12 weeks.   "
64355|NCT02443298|"     The objectives of this trial are primarily to evaluate the efficacy and safety of BI     655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in     severe asthma patients. The primary endpoint is time to first asthma worsening during the     planned 24 week treatment period for active vs. placebo treated patients on top of standard     of care therapy. Upon demonstration of a meaningful clinical response, another important     objective is the identification of biomarkers that can be used to target patients who will     likely respond to treatment with BI 655066/ABBV-066 (risankizumab).   "
64128|NCT02446262|"     Background:      - Painful stimuli cause changes in a network of brain regions called the Pain Matrix. But     most of these regions respond to many other stimuli, not just pain. Researchers want to     understand how different factors influence pain. They want to test what happens when people     expect different levels of pain and receive treatments that can modify pain. They want to see     if these factors influence decisions about pain and how the body responds to it. They also     want to compare pain with responses like taste and vision.      Objectives:      - To better understand how pain and emotions are processed and influenced by psychological     factors.      Eligibility:      - Healthy volunteers ages 18 50.      Design:        -  This study requires 1 to 2 clinic visits that last 1 to 3 hours.        -  Participants will be screened with medical history and physical exam.        -  Some participants will have one or more magnetic resonance imaging (MRI) scans of their          brain. For MRI, participants will lie on a table that slides in and out of a cylinder.          The scanner makes loud knocking noises. They will get earplugs.        -  Participants heart activity will be recorded with electrocardiogram. Their pulse,          sweating, and breathing will be monitored.        -  Some participants will take a taste test. Others may perform simple tasks. Others may          receive pain in their arm, leg, or hand. The pain will come from heat or electric          shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests          may be given during MRI.        -  Participants will fill out questionnaires.        -  The study will last 3 years.   "
64129|NCT02446249|"     Background:      - Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can     cause problems like infections and tooth decay. Researchers hope a new drug can help people     with dry mouth caused by radiation.      Objectives:      - To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in     people whose parotid glands have had radiation.      Eligibility:      - People at least 18 years of age with a history of radiation therapy for head and neck     cancer.      Design:        -  Participants will be screened in 2 visits with:        -  medical history        -  physical exam        -  scans        -  saliva collections        -  sialogram. A substance is injected in the parotid gland and X-rays are taken.        -  non-drug infusion        -  IV dose of glycopyrrolate to stop saliva        -  3-day hospital stay: Participants will get the gene infusion. The AAV2hAQP1 will be in a          solution in a syringe. It will be slowly pushed through an opening into the gland inside          your mouth..        -  10 outpatient visits over 3 years. These may include:        -  repeats of screening tests        -  blood and urine tests        -  oral and head and neck exams, including a thin scope in the airway        -  questionnaires        -  small piece of skin taken        -  small piece of tumor tissue taken by either:        -  a small video-scope in the parotid duct that also takes pictures        -  or by a small needle guided by ultrasound        -  scans. Participants lie in a machine or a scanner The machine may feel close to the body          or face. . For some, a substance will be injected in a vein or put in the mouth.<TAB>        -  Participants will keep a diary about how they feel before and after the therapy.   "
64130|NCT02446236|"     This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib     (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell     lymphoma.   "
64131|NCT02446223|"     Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic     Keratosis of the Chest w/Ingenol Mebutate 0.015%   "
64132|NCT02446210|"     The long‐term goal is to acquire scientific knowledge that can be used to develop     mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor     function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed     project will examine cortical, corticospinal, and spinal contribution to bilateral hand and     arm muscle activity during bilateral movements and spinal contributions to lower limb muscle     activity. By comparing changes in different sites within the Central Nervous System (CNS),     the investigators may also identify key mechanisms that might be differentially affected by     the injury, plasticity, and training.   "
64133|NCT02446197|"     Early initiation of therapy post stroke has been associated with improved long-term outcomes,     and functional activity dose during the first week of inpatient rehabilitation predicts both     gait velocity at discharge and length of time to independent walking. The primary study     objective is to pilot the feasibility of integrating a patient-directed activity program into     inpatient rehabilitation following stroke. The second study objective is to identify if     participation in the patient-directed activity program improves functional ability and health     related quality of life.   "
64134|NCT02446184|"     This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal     cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and     to compare to the investigators clinical experience with fetal vesicoamniotic shunting.   "
64135|NCT02446171|"     This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover,     single-center, single-dose bioavailability study with alternate methods of administration of     crushed naloxegol tablets, 25 mg and of a naloxegol solution formulation, 25 mg, compared to     whole naloxegol tablets, 25 mg, in healthy subjects.      The main objective of this study is to determine the bioavailability of each of three     alternative methods of naloxegol administration compared to whole naloxegol tablets given     orally by assessment of the primary pharmacokinetic (PK) parameters of naloxegol   "
64136|NCT02446158|"     Chlorhexidine is used in central line dressing changes and is effective in reducing line     infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis     (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or exit site     infection.   "
64171|NCT02445703|"     The purpose of this study is to compare the immunogenicity and safety of three different     immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A     and B vaccine (HABV) in healthy Chinese infants.   "
64172|NCT02445690|"     One hundred and fifty patients with Crohn's disease involving the terminal ileum or the     colon, in clinical remission, with or without endoscopic activity will be included. Thrombin     generation will be measured and correlated with the simplified endoscopic activity score. The     patients will be evaluated for development of deep vein thrombosis after one-year of     follow-up.   "
66240|NCT02418663|"     The aim of this study is to determine the prevalence of Fluid Responsiveness (FR) (SV     increases by at least 15% after Volume Expansion, VE) in postoperative patients admitted on a     surgical ward after elective abdominal, thoracic and esophageal surgery   "
64137|NCT02446145|"     Acute myeloid leukemia (AML) is a disease with a poor prognosis including a 5-year overall     survival (OS) of app. 20% for the entire population. In particular, the outcome of elderly     patients with AML is dismal and the majority of patients die within the first year after     diagnosis. This is also because treatment options for elderly patients with AML significantly     differ from patients of younger age. In fact, comorbid conditions are common among the     elderly such as heart disease, renal insufficiency and vascular disease thus influencing the     ability to withstand intensive therapy. Elderly patients are also more likely than younger     patients to develop severe, life threatening infections during the course of treatment. In     addition to infectious complications, hemorrhages due to severe thrombocytopenia are     responsible for morbidity and mortality in a considerable amount of patients. Compared with     younger AML patients, elderly individuals with AML display a higher incidence of     poor-prognosis karyotypes, of a preceding myelodysplastic syndrome (MDS), and greater     expression of proteins involved in intrinsic resistance to chemotherapeutic agents. As a     result conventional anthracycline based chemotherapy is only infrequently used in patients     above the age of 65 years. Based on a recent randomized trial (Kantarjian et al. 2012)     low-intensity epigenetic therapy with decitabine (DAC) has become the first-line standard of     care in most European countries including Germany. Nevertheless, even with this treatment the     1-year OS is approximately 30 % only. Furthermore, severe thrombocytopenia is a main side     effect of this therapy and can prevent adequate continuation of treatment being crucially for     treatment success. Supportive care with platelet transfusions is effective primarily only     over short periods and often requires hospitalization and therefore lowers the quality of     life of these patients in their palliative situation. Therefore, patients could benefit from     an approach aiming at an increase of platelet counts through combined use of DAC with an oral     thrombopoietin receptor agonist like eltrombopag (EPAG). This could allow for a better     adherence to DAC therapy by preventing dose delays due to prolonged thrombocytopenia.     Additionally, the potential antileukemic effect of EPAG could also be beneficial for these     AML patients.   "
64138|NCT02446132|"     This is an extension study of the Phase 3 Studies 15-AVP-786-301 and 15-AVP-786-302, which     also allows participants from the Phase 2 Study 12-AVR-131 to be included.   "
64139|NCT02446119|"     Gastroparesis is a disorder characterized by symptoms from gastric retention in the absence     of mechanical obstruction. Gastric emptying is a highly regulated process reflecting the     integration of the propulsive forces of proximal fundic tone and distal antral contractions     with the functional resistance provided by the pyloric sphincter. Pylorospasm has been     reported in some patients with gastroparesis. This study protocol will assess pyloric     sphincter pressure and geometry in patients with gastroparesis and control subjects without     symptoms of gastroparesis. The commercially available FDA approved endoscopic functional     luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure,     length, and distensibility of gastrointestinal sphincter muscles along the balloon distance.     It is used to measure the pressure characteristics of the lower esophageal sphincter during     bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen     fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy,     which is routinely performed under sedation, patients with gastroparesis and controls without     gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After     passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside     the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The     investigators will measure the pressure and contour of the pyloric sphincter using three     successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The     investigators will compare the results between the gastroparesis patients and the control     patients without gastroparesis. Through this study, the investigators will better understand     the abnormalities of the pyloric sphincter in patients with gastroparesis.   "
64140|NCT02446106|"     The objective of this study is to compare energy intake following consumption 0.5% MSG versus     a control with no added MSG and matched for sodium in healthy non-smoking premenopausal     female adults.   "
64141|NCT02446093|"     The study will investigate if the addition of GMCI to neoadjuvant mFOLFIRINOX +     chemoradiation is safe and improves the clinical outcome of borderline resectable and     unresectable locally advanced pancreatic adenocarcinoma, as measured by resection rate,     progression-free survival and overall survival.   "
64142|NCT02446080|"     Constipation is defined as a disorder characterized by persistent difficulty to evacuate or a     feeling of incomplete evacuation and / or infrequent bowel movements. Many factors contribute     to the onset of constipation, such as changes in dietary intake and fluid intake, decrease in     consumption of products containing fiber, intake of drugs or laxatives, decreased intestinal     motility and physical inactivity. The objective was to evaluate the effect of consumption of     dairy products with probiotics on constipation. Randomized double-blind clinical trial in the     city of Bom Retiro do Sul / RS, Brazil. They were recruited 60 female patients aged 20-50     years after application of the Rome III criteria (World Gastroenterology Organization, 2010)     and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with     constipation. Patients were randomized into two groups, where one group will receive the milk     drink with probiotics and the other group will receive a probiotic milk drink without     (control group). The milk beverage consumption period shall be 60 days where each patient     will consume 150 ml of milk drink a day, with breakfast or morning snack.   "
64143|NCT02446067|"     The present study measures the cerebral hemodynamic indices of alcohol dependent patients and     observe the relative changes in these parameters with rTMS application.   "
64144|NCT02446054|"     Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet     control   "
64145|NCT02446041|"     The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness     of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months     after initiation of therapy between COPD patients who are adherent to the index medication     and those who are non-adherent.   "
64146|NCT02446028|"     The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to     Humalog®Mix 75/25 in patients with type 2 diabetes.   "
64147|NCT02446015|"     The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant     Eye Drops using total ocular surface staining scores in subjects with dry eye administering     it either as a scheduled regimen or as-needed after 28 days of treatment.   "
64148|NCT02446002|"     A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple     doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the     single dose pharmacokinetics of the oral lofexidine formulation.   "
64149|NCT02445989|"     The investigators propose to explore the hypothesis—supported by limited data—that a     contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing,     will enhance women's genital and reproductive health. The investigators propose that this CVR     will increase the bacteria that help the vaginal environment protect against infection by HIV     and other STIs, and that in women who already have HIV, use of the CVR will lower the     quantity of HIV that is shed in the female genital tract.   "
64150|NCT02445976|"     The goal of this clinical study is to determine the efficacy and safety of Seviteronel, a     lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with     castration-resistant prostate cancer (CRPC) who have been previously treated with     enzalutamide and/or abiraterone.   "
64151|NCT02445963|"     This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a     InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a     InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).   "
64153|NCT02445937|"     This is a comparative, effectiveness trial with the overarching goal of this research project     to ensure patient-centered decisions about the use of intensive treatments for patients with     advanced critical illness. In a prior project, the investigators developed the PARTNER     program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a     4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs,     including: 1) changing care defaults to ensure clinician-family meetings within 48 hours of     enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and     emotional support of surrogates before and during clinician-family meetings, 3) increased use     of palliative care services for patients with a poor prognosis; and 4) structured     communication at care transitions about patient's health care preferences and goals. The     investigators propose to begin deployment of the PARTNERII program in the spring of 2015     enrolling 690 patients and 690 surrogate decision makers in 5 ICUs using a stepped wedge     design. The investigators expect to achieve the following project goals:        1. To increase the patient-centeredness of end-of-life decisions, and to increase the          quality of clinician-family communication.        2. To decrease the psychological burden on family members acting as surrogates.        3. Lower costs: To reduce total health care costs by increasing the use of palliative care          and hospice services and decreasing unwanted readmissions near the end of life.   "
64154|NCT02445924|"     This study will be carried out on 40 subjects at Chest department Tanta university hospital      The subjects will be classified into three groups:        -  Group I: will include ten non smoker volunteers (control group I).        -  GroupII: will include ten smoker volunteers (control groupII).        -  Group III: will include twenty NSCLC patients confirmed by pathological examination of          bronchoalveolar examination (BAL), brush and/or biopsy.   "
64155|NCT02445911|"     This study will consist of multiple ascending oral doses in up to 3 groups, for 29 days.   "
64156|NCT02445898|"     The study evaluates the pathophysiological effects of a single dose Methylprednisolone     administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the     effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV)     to evaluate the efficacy of Methylprednisolone regarding blood pressure regulation and     autonomic responses after THA.      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will     receive placebo.      The investigators hypothesize that the group receiving Methylprednisolone will be less     orthostatic intolerant, experience less orthostatic hypotension and have an improved     autonomic response compared to the placebo-group, early after THA.   "
64157|NCT02445885|"     Although recommended therapy for patients with ST-segment elevation myocardial infarction is     primary PCI, it remains unestablished whether patients with a symptom duration of more 12     hours benefit from acute revascularisation.      This study aims to investigate whether acute intervention is superior to subacute     intervention in these patients.   "
64158|NCT02445872|"     Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of     chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to     evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients     receiving 3-day cisplatin-based chemotherapy.   "
64159|NCT02445859|"     We propose to randomise patients due to undergo colorectal surgery to standard antibiotic     prophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical wound     infection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime,     repeated every 4 hours. The intervention regimen is a loading dose of cefuroxime followed by     a continuous infusion of cefuroxime until the end of surgery. The intervention regimen dosing     will be calculated using a patient's renal function and body weight. The intervention regimen     will target a free serum drug concentration of 64mg/L. This serum level is 4x the MIC90 for     colonising Enterobacteriaceae. The rational for this dosing regimen is summarised below. The     primary objective of the study is to reduce by 50% the rate of surgical wound infections     after colorectal surgery.   "
64160|NCT02445846|"     The purpose of this study is to provide evidence on the performance and operational     characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in     Zambia for their introduction into antenatal care and other settings.   "
64161|NCT02445833|"     Efficacy of an Internet-based self-guided intervention for promoting healthy habits and     weight loss in hypertensive people with overweight and obesity: A Randomized Controlled Trial   "
64162|NCT02445820|"     This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES)     130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid     therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery     patients.   "
64163|NCT02445807|"     This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical     treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.   "
64164|NCT02445794|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     RT001 in patients with Friedreich's ataxia.   "
64165|NCT02445781|"     Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To     date no studies appear to have investigated the effects of differing levels of hypoglycemia     on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The     specific aim of our study will be to determine the effects of differing levels of     hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.   "
64166|NCT02445768|"     The purpose now is to:        1. identify brain connections related to proprioception to have a better understanding of          differences between people with stroke and healthy persons        2. evaluate how these brain connections will change in people with stroke when they are          engaged in a 6-week neurocognitive therapeutic program.   "
64167|NCT02445755|"     The purpose of this study is to test the performance of a new transcutaneous (measured     through skin) bilirubin device (BiliCare™) to measure bilirubin levels. The investigators     plan to evaluate the clinical performance of this device as a point of care test. If the     investigators can validate the BiliCare™ with bilirubin from your baby's blood they could     verify a non-invasive alternative for measuring bilirubin.   "
64221|NCT02445053|"     To describe the effectiveness of Kalydeco® treatment in patients with cystic fibrosis (CF)     who have 1 of 8 non G551D gating CFTR mutations (G178R, S549N, S549R, G551S, G1244E, S1251N,     S1255P, or G1349D).   "
64173|NCT02445677|"     Introduction: Chronic pain affects more than half of elderly individuals. Past studies have     shown that pain can interfere with motor learning and rehabilitation. It was suggested that     relieving pain before physical therapy sessions might be an interesting strategy to     potentiate the rehabilitation of older patients suffering from pain.      Objective: This study aims to determine if the analgesic effect induced by TENS can be used     to maximize the rehabilitation of elderly patients suffering from chronic pain. More     specifically, the objectives are to: 1) compare functional outcomes of patients from the Day     Hospital receiving rehabilitation with either active TENS treatments or simulated TENS     treatments, and 2) determine if there is an association between the analgesic effect of TENS     and the clinical evolution of patients following their rehabilitation.      Methods: In this RCT, patients will be assigned randomly to either the: 1) experimental group     receiving active TENS treatments or 2) the control group receiving simulated TENS treatments.     Thirty-six patients will be recruited according to the following criteria: 1) will receive     physiotherapy rehabilitation at the Day Hospital of the CSSS-IUGS, 2) be at least 65 years of     age, 3) suffering from chronic pain (pain lasting for more than 6 months), 4) presenting pain     during the rehabilitation at the Day hospital. For security reasons, patients with a cardiac     simulator will be excluded from the present study (TENS contraindications). Patients with     cognitive alterations (score of < 24/30 at the Folstein test) will also be excluded.     Sociodemographic information will be retrieved from medical records by the research assistant     at baseline (T1). Moreover, various questionnaires will be administered at T1, after half of     the rehabilitation period (i.e. 4 to 6 weeks) (T2), and after the 8- to 12- week     rehabilitation period (T3) to measure the qualitative aspects of pain, mood, and physical     function. Functional outcomes will as well be collected directly from the medical record at     each assessment times (T1, T2 and T3).The measures include exercise tolerance, balance,     mobility and balance, and functional ability.      Anticipated results: We believe that: 1) use of active TENS during the rehabilitation     sessions will potentiate rehabilitation of patients suffering from chronic pain at the     CSSS-IUGS Day Hospital, and 2) there is a relationship between the analgesic effect induced     by TENS and the clinical evolution of patients.   "
64174|NCT02445664|"     Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized     problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and     involvement. In this study the investigators aimed to determine the effect of an educational     video displayed on a tablet-device. The investigators hypothesized that an educational video     would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.   "
64175|NCT02445651|"     Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more     than a million Americans. It's most prominent pathology is the degeneration of dopaminergic     neurons in the brain. It is believed that oxidative stress and inflammation play an important     role in the pathophysiology of Parkinson's disease as well.      The object of this study is to evaluate whether nutritional supplementation with compounds     that have been shown to have either anti- inflammatory, or antioxidant effects, might support     brain function in patients with Parkinson's disease, particularly in regards to the dopamine     system. Enrolled patients will be randomly assigned to receive oral and intravenous n-acetyl     cysteine (NAC), or standard PD care. This study will utilize Ioflupane (DaTscan) single     photon emission computed tomography (SPECT) to measure dopamine function, magnetic resonance     spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological     measures to assess clinical symptoms, in patients with PD. Subjects will receive a DaTSCAN     and MRS initially and after completing the supplement or NAC regimen.   "
64176|NCT02445638|"     The objective of this randomized, single blinded cross-over study is to investigate effects     of daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL)     composition and function in a population of overweight and obese postmenopausal women.   "
64177|NCT02445625|"     This study aims to demonstrate that improvements in identification of social clues (and     improvement of overall social behaviour) in subjects with ASD can be achieved using social     games together with a BCI setup.      The primary goal is to ensure increased rate of responses to joint attention cues.      Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initial     eligibility screening (within 1 week after admission), (2) pre-intervention (first week of     study, baseline outcome measures and additional evaluations), (3) intervention process (16     weeks), (4) post-intervention (outcome measures and additional evaluations), and (5)     follow-up (outcome measures at 6 months).   "
64178|NCT02445612|"     The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE     cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to     five years following the surgical procedure to implant the MA09-hRPE cells.   "
64179|NCT02445599|"     The purpose of the study is to examine if the hyposthesis of the preventive analgestic     characteristic of diclofenac given preoperatively has any effect on postoperative thoracic     wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption     and the postoperative lung function test values.   "
64180|NCT02445586|"     This is a Phase 4, single-arm, open-label, multicenter study to assess the safety and     efficacy of pertuzumab in combination with trastuzumab and docetaxel for the treatment of     participants with human epidermal growth factor receptor 2 (HER2)-positive advanced (locally     recurrent, unresectable, or metastatic) breast cancer.   "
64181|NCT02445573|"     The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA)     for women with pure stress urinary incontinence (SUI).   "
64182|NCT02445560|"     The purpose of the proposed study is to determine the effects of consuming a high protein     diet on fecal microbial communities, gastrointestinal function and symptoms, and general     wellness in older adults.   "
64183|NCT02445547|"     Stem cell transplantation has emerged as a relatively popular treatment that can help to     regulate immunity, repair injury, and control inflammation. Several studies have used     autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its     associated complications, and have achieved good efficacy. Thus far, the use of umbilical     cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In     this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We     observed the disease control conditions, corticosteroid dosage changes, and treatment-related     adverse reactions.   "
64184|NCT02445534|"     Although several studies have demonstrated beneficial effects of stem cell therapy in     patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of     response to therapy remain undefined. The aim of this registry is to pool long-term clinical     data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy     in an attempt to better define predictors of response to such treatment.   "
64185|NCT02445521|"     The objective of this study is to test four home phenylalanine monitoring prototype devices,     selected out of a pool of candidates by the National PKU Alliance Scientific Committee.   "
64222|NCT02445040|"     The purpose of this study is to determine the safety and effectiveness of the Babylog VN500     in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth     weight (VLBW) neonates requiring invasive respiratory support in the treatment of respiratory     distress.   "
64186|NCT02445508|"     Accumulating evidence suggests that bile acids in our intestines may constitute essential     components in the complex mechanisms regulating gut hormone secretion and glucose     homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile     acids can lead to changes in gut hormone secretion and consequently affect glucose     homeostasis.      The current study is a human interventional randomized controlled cross-over study including     four study days for each participant. As a tool to sequester bile acids we will use     sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult     patients with chronic kidney disease. Surprisingly, sevelamer has been shown to improve     glycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenous     infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The     aim is to examine how (and if) bile acid sequestration can influence postprandial     glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2     diabetes.      The investigators hypothesize that higher luminal concentrations of bile acids in the distal     gut will elicit changes in gut hormone secretion. The current study will help to clarify this     hypothesis and improve our general understanding of the association between bile acid     circulation and signalling, gut hormone secretion and glucose metabolism.   "
64187|NCT02445495|"     The purpose of this study is to determine if toenail onychomycosis can be reduced by means of     exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.   "
64188|NCT02445482|"     In recent years, the advance in high-throughput techniques, such as microarrays and next gen     sequencing (NGS) technologies, have allowed a more precise classification of the breast     cancer molecular subtypes and a more personalized approach to anti-cancer therapy. To date,     conventional methods to select patients for clinical trials with anti-targeted agents     according to molecular criteria are generally limited to the analysis of a few biomarkers.     Recent studies have shown how this strategy is inappropriate in case of infrequent molecular     alterations and that the ideal strategy would consist in simultaneous examination of large     numbers of actionable genomic alterations.      This is the first genomic screening platform ever attempted in Spain. By this molecular     platform SOLTI aims to increase the likelihood of a patient being included in a trial     designed specifically for her molecular tumor type. Thus, the primary objective of this pilot     study is to determine the Platform's effectiveness to include patients in clinical trials     with targeted agents based on the tumor molecular profiling.   "
64189|NCT02445469|"     Parkinsonian syndrome is clinically characterized by the presence of resting tremor,     rigidity, bradykinesia and postural instability. Parkinsonian disorders include Parkinson's     disease (PD), progressive supranuclear palsy (PSP), corticobasal dementia (CBD), multiple     system atrophy (MSA) and vascular parkinsonism (VP). Each of these diseases has a singular     physiopathological origin, course and prognosis. Numerous imaging studies consequently aimed     at finding markers to early make the distinction between the different types of parkinsonism,     in order to identify patients who could benefit from dopaminergic agonist therapy.      Excessive iron deposition in the subcortical and brainstem nuclei has been described in     numerous neurodegenerative disorders including Parkinson's disease. Increased iron levels are     more frequent in area that are rich in dopaminergic neurons and have been implicated in the     development of movement disorders, the distribution of areas with increased iron deposition     however varying according to parkinsonism types. Iron deposition quantification could thus     potentially help in differentiating parkinsonism types and could improve therapy guidance.     Quantitative susceptibility mapping (QSM) locally estimates the magnetic susceptibility of     brain tissues based on gradient-echo signal phase. The local susceptibility being sensitive     to the presence of paramagnetic susbtances, QSM allows the non-invasive evaluation of iron     distribution and quantification in the brain with high image quality (Liu et al., 2013).     However, since iron deposition followed an exponential curve during normal aging in most of     the basal ganglia the potential of QSM to distinguish between healthy and parkinsonian     subjects in elderly remains unclear.      The aim of this study was thus to determine susceptibility values in the basal ganglia of     elderly patients with parkinsonian syndromes, to compare these values to healthy aged-matched     controls and between parkinsonian syndrome types. Secondly, investigators aimed to evaluate     microstructural changes in the basal ganglia using diffusion tensor imaging (DTI) in the same     population and to determine whether susceptibility and DTI parameter changes are correlated.     Finally investigators sought to assess the relation between susceptibility/DTI parameter     values in the basal ganglia and behavioral measures of motor and cognitive abilities.   "
64190|NCT02445456|"     This study will assess whether the Sienna+/Sentimag system, which involves a magnetic tracer,     is effective in identifying the sentinel lymph node in rectal cancer and whether it is then     feasible to remove this lymph node during surgery to locally excise early rectal cancer.   "
64191|NCT02445443|"     The purpose of the current investigation is to assess the safety and efficacy of a new hinged     revision knee device. This device is designed to provide efficient, reproducible     reconstructions with optimal limb and implant alignment, durable implant fixation, and     functional outcomes that increasingly approach those of primary Total Knee Arthroplasty     (TKA).   "
64192|NCT02445430|"     The goal of this study is to identify genetic alterations resulting in the development of     arteriovenous malformation (AVM) in the central nervous system.   "
64193|NCT02445417|"     The purpose of this study is early identification of asphyxiated newborns through eeg     starting in the delivery room.   "
64194|NCT02445404|"     This study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated     ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-cell Lymphoma.   "
64195|NCT02445391|"     This randomized phase III trial studies how well cisplatin or carboplatin (platinum based     chemotherapy) works compared to capecitabine in treating patients with remaining (residual)     basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant).     Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin     or carboplatin is more effective than capecitabine in treating patients with residual triple     negative basal-like breast cancer.   "
64196|NCT02445378|"     This randomized clinical trial studies aromatherapy and essential oils in improving insomnia     and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and     essential oils may help improve insomnia and other complications caused by chemotherapy.   "
64223|NCT02445027|"     The goal of this study is to test the feasibility and acceptability of tethered capsule     Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening     in the primary care practice environment.   "
64224|NCT02445014|"     The goal of this research is to test the feasibility and tolerability of the modified, larger     diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects,     subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease     (GERD). This information will be used to assess optimal imaging technique, imaging quality,     and subject tolerability.   "
64197|NCT02445365|"     Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time     of diagnosis it is not possible to predict the course of the disease, which can range from a     few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and     stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic     tools.      This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic     conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The     investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage     has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief and     non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC is     likely to involve suppressed inflammation and cell death.      Our study is a randomized clinical controlled study including 38 patients. Patients will     receive RIC or sham for 10 consecutive days.      The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy     findings, and various markers in the blood, faeces and the intestinal wall.   "
64198|NCT02445352|"     The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with     primary hypercholesterolemia.   "
64199|NCT02445339|"     Our primary aim is to assess the feasibility of initiating treatment in the ED with     extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and     continuing care in cooperation with clinic providers as well as how best to assess outcomes.     Secondarily, the investigators will explore its effect on various health outcomes (healthcare     utilization and engagement, expenditures, drinking and consequences, quality of life) as well     as the association of patient-level characteristics (e.g. sex, race, baseline drinking,     health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining     both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is     essential before planning a large-scale effectiveness trial (phase 2).   "
64200|NCT02445326|"     The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained     release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the     treatment of the signs and symptoms of chronic allergic conjunctivitis.   "
64201|NCT02445313|"     The investigators would like to know if different imaging devices can improve the quality of     images and visualization of imaged tissues. Also, the investigators would like to find out     whether these changes are useful in the diagnosis and treatment of eye diseases. Using images     of previous participants will allow us to demonstrate the advancement of different     technologies, as well be used to allow comparisons between current technologies.   "
64202|NCT02445300|"     The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant     improvement in the efficacy of wound care and wound complications compared with traditional     Sofra-Tulle® dressings after minimally invasive total knee arthroplasty (MIS-TKA).   "
64203|NCT02445287|"     The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM     Cone Beam Computed Tomography (CBCT) scanner (investigational device) against the     commercially available 2D and 3D predicate devices. The results of this study will be     included in a Traditional 510(k) FDA Submission to obtain clearance to market the new     CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in     accordance with the FDA Guidance titled Guidance for the Submission of 510(k)'s for Solid     State X-ray Imaging Devices, issued on August 6, 1999.   "
64204|NCT02445274|"     In this study, the investigators introduce a new capsule-reserved cataract surgical     procedure in which anterior lens capsule is reserved and attached onto posterior lens capsule     in the purpose of preventing posterior capsule opacification (PCO). A prospective randomized     controlled study is reported to compare the new capsule-reserved surgical procedure with     conventional one on the effectiveness to prevent posterior capsule opacification in     age-related cataract patients.   "
64205|NCT02445261|"     Women were instructed not to use the mobile phones for 24 hours before carrying out the     initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace     recording was done followed by umbilical artery Doppler ultrasound using high resolution     ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic     a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the     mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The     umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference     with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal     heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with     respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of     fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of     spontaneous decelerations.   "
64206|NCT02445248|"     This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in     adult patients with relapsed or refractory DLBCL.   "
64207|NCT02445235|"     This observational study is designed to evaluate the reported outcomes for patients receiving     topical therapy for the treatment of pain, fungal infections or skin scars. The patients will     complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the     patients perception of their health status and well being while receiving therapy.   "
64208|NCT02445222|"     Per Health Authorities guidelines for gene therapy medicinal products that utilize     integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of     treated patients is required. The purpose of this study is to monitor all patients exposed to     CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019)     infusion to assess the risk of delayed adverse events (AEs), monitor for replication     competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.   "
64209|NCT02445209|"     The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and     mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and     gastroesophageal junction (GEJ) adenocarcinoma   "
64225|NCT02445001|"     Instead of the usual procedure of injecting ICG dye directly into an arm vein, now the dye     can be placed inside of RBCs. When a small volume of the RBC's with the dye is injected into     a person's arm, the individual RBCs can be seen as they flow through the retinal blood     vessels.   "
64210|NCT02445196|"     PTSD Coach is a mobile application (app) that aims to teach individuals self-management     strategies for symptoms of Post-traumatic Stress Disorder (PTSD). PTSD is a major public     health concern. Although effective treatments exist, affected individuals face many barriers     to receiving traditional care. As smartphones are now carried by more than half of the U.S.     population, they have the potential to overcome many of these barriers by delivering     self-help interventions on apps. Despite PTSD Coach's use of evidence-based cognitive     behavioral strategies there is still a need to test the effectiveness of the app in managing     PTSD symptoms. This controlled, two-arm, randomized (1:1) trial will evaluate the efficacy,     feasibility and acceptability of PTSD Coach to reduce PTSD symptoms in a community sample of     trauma survivors with PTSD symptoms. After completing an eligibility phone screen or online     screen, individuals who score a 35 or above on the PTSD Checklist (PCL) and consent will     complete a baseline assessment and then be randomized to the PTSD Coach app condition or a     waitlist control group. Additionally, those assigned to the PTSD Coach intervention will be     instructed to download a research version of the app, called PTSD Explorer, that enables     passive and objective monitoring of app use. Each individual will be reassessed at     post-intervention (3 months) and follow-up (3 months later, or 6 months after completing     baseline). The investigators predict that those using the PTSD Coach app will demonstrate a     significant and sustained reduction in PTSD symptoms and increase in patient coping     self-efficacy compared to the waitlist control group. The investigators will explore if there     is a relationship between levels of engagement and PTSD symptom change.   "
64211|NCT02445183|"     The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an     ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported     by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively     verified with additional medical data collection pertaining to lung cancer. Additional     'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data     previously collected through the COPDGene® Study, including QCT results and clinical results     (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for     analysis.   "
64212|NCT02445170|"     The present study assesses the health-related quality of life of diabetic transmetatarstal     and below-knee prosthetic user. The study design is cross-sectional with a retrospective     review of patient hospital records and an assessment with patient-reported outcome measure.   "
64213|NCT02445157|"     This study is investigating the reliability of the 4 metre gait speed test (4MGS) in patients     with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).   "
64214|NCT02445144|"     Patients with sickle cell anemia (SCA) are at an increased risk for damage to brain tissue     due to their disease. The investigators are interested in how blood flow and cerebral     inflammation are different in SCA patients and how that affects brain tissue- the     investigators will use a relatively new set of dynamic MRI techniques to evaluate these     parameters. The investigators will image participants with both SCA and matched controls with     non-invasive MRI.   "
64215|NCT02445131|"     The CLL2-BCG-trial is a prospective, open-label, multicenter phase-II-trial to evaluate the     efficacy and safety of a sequential regimen of a debulking with bendamustine followed by an     induction with GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and     GA101-maintenance in CLL patients   "
64216|NCT02445118|"     This is a 16 week pilot study to assess short term outcomes of an injectable allograft     adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30     patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume retention     and local skin changes will be observed and documented prior to and following injection at     week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be done via     photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergo     magnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as a     control and will receive no injection. Analysis includes volume retention, tissue analysis,     local skin changes and adverse events, if any.   "
64217|NCT02445105|"     This multisite study will compare the effectiveness of universal screening by 3 community     service systems using Autism Navigator, a highly interactive web platform that includes an     automated screening tool, information about autism for families, and a professional     development course on the early signs of autism and effective evidence-based practice with     extensive video footage to rapidly build the capacity for early detection. The investigators     will also conduct a multisite pragmatic randomized clinical trial to test the effectiveness     of an evidence-based Family Engagement Intervention compared to Autism Navigator Enhanced     Practice implemented by the 3 community service systems with children who have a positive     autism screen to increase the number of children who are screened, referred for evaluation,     receive a diagnosis, and receive community-based EI between 18-27 months of age. This study     will impact family engagement in community screening and diagnosis by demonstrating the     effectiveness of brief manualized engagement interventions. Findings will advance science by     providing researchers with a method for recruiting a community sample, allowing for research     at younger ages, which could accelerate science.   "
64218|NCT02445092|"     The investigators hypothesize that washing the insemination catheter prior to performing the     IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when     compared to controls (without pre-washing the catheter).      Catheter washing is performed routinely before embryo transfer, however it is not done for     IUI catheters. Therefore no data is available on applying the technique to IUI catheters     prior to insemination.   "
64220|NCT02445066|"     This pilot study is a 4-month open label trial in 15 older (65-89 yrs) men and women with     initial 25(OH)D concentrations of 12-<18 ng/mL to explore the effect of increasing 25(OH)D     concentrations to ≥30 ng/mL through vitamin D3 supplementation on changes in mitochondrial     bioenergetics. We will assess the bioenergetic profile of blood cells isolated mitochondria,     and muscle fibers as well as the expression of mitochondrial proteins and regulators of     mitochondria biogenesis before and after supplementation. All participants will be given     vitamin D3 (4,000 IU/d) for 4 months.   "
64440|NCT02442193|"     The overall aim of the study is to assess the feasibility of conducting a Randomized     Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support     (IPS) in improving employment rates and associated psychosocial outcomes in forensic     psychiatric populations.   "
64226|NCT02444988|"     The administration of intravenous fluids is ubiquitous in the care of the critically ill.     Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte     compositions including a range chloride concentrations. Recent studies have associated     solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and     renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased     mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a     large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from     the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary     endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment     (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at     discharge).   "
64227|NCT02444975|"     The purpose of this study is to determine whether increased water intake is effective in     preventing episodes of uncomplicated urinary tract infections (UTI) in pre-menopausal women     suffering from UTI recurrences.   "
64228|NCT02444962|"     At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center     (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an     episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant     based episthesis are now commonly used because of the good retention and episthesis     stability. This results in a better patient quality of life.      Today we use machined surface implants in the craniofacial region of different brands. Each     system has its own instruments and application method. To enhance the clinical usability, we     are searching for one system for all extra-oral implant regions.      Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and     radiation therapy, which can affect the bone healing process. In these cases, implants are     known to have higher failure rates compared to the application in healthy cases. Therefore     implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may     have a positive effect on osseointegration, resulting in higher success rates in the     compromised patient.      The aim of this pilot study is to collect information about the functionality and safety of a     surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative     surgery in the nasal, orbital and auricular region for a potential future RCT.   "
64229|NCT02444949|"     Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of     recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way     of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil     (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of     angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease     the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar)     can improve the sensitivity to chemoradiation via selectively inhibiting the migration of     endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular     remodeling and normalization of the tumor vasculature, which will effectively aid the     delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with     chemoradiotherapy will be a promising way of treatment for NPC. In this study, the     first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with     recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group     (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a     control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including     progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse     effects rate and quality of life. This research will provide more evidences of evidence-based     medicine for the safety and tolerability of endostar and the clinical application of endostar     in NPC treatment.   "
64230|NCT02444936|"     This study evaluates if the shingles vaccine works in those persons that receive it before     they receive chemotherapy for solid organ tumors. Half of the participants will receive the     ZOSTAVAX shingle vaccine and half of the participants will not received anything.   "
64231|NCT02444923|"     The most common causes for irregular cornea (IC) in hospital contact lens practice are     Keratoconus (KC) and related cornea thinning disorders. These conditions cause mild to marked     impairment of vision and cannot be effectively corrected by spectacles and soft contact     lenses. The gold standard in the management of KC is Corneal Rigid Gas Permeable contact     lenses (corneal lenses), which correct approximately 90% of the corneal irregularity.      Compared with a normal cornea, the cornea in KC is irregular and this results in a compromise     to the fit of rigid corneal lenses. Specifically, they bear on the cornea and this, together     with the vulnerability of the cornea in KC, are implicated in corneal scarring, and disease     progression as well as a significantly reduced vision related quality of life (QoL) in KC     compared with corneal lens wearers who have no KC.      In cases where the compromise fit of corneal lenses proves problematic, large diameter     Scleral RGP contact lenses (scleral lenses) may be used as a problem solver. Unlike the     smaller corneal lenses which bear on the cornea, the scleral lenses completely bridge over     the cornea and bear on the sclera.      The aim of this research is to investigate the performance of scleral lenses in KC     participants who habitually wear corneal lenses.      The research question: is there a measurable difference in the visual performance and visual     quality of life in participants with Irregular cornea disorders like keratoconus and other     related conditions, who habitually wear corneal lenses in comparison with scleral lenses.   "
64246|NCT02444728|"     Treating severe thrombocytopenia is a challenge in the management of systemic lupus     erythematosus. Although rheumatologists have followed some rules in real practice,there is     very few evidence to support the current treatment algorithm. The purpose of this study is to     compare the complete remission rate and partial remission rate of cyclophosphamide and     hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.   "
64264|NCT02444494|"     The objective of this non-interventional study is to evaluate clinical effectiveness and cost     effectiveness of Dysport within the reimbursement scheme called drug programme funded by     Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to     collect data in patients scheduled to receive Dysport treatment in a drug programme, based on     routine treatment of subject with ULS.   "
65361|NCT02430142|"     Forearm vasoocclusive testing (VOT) will be performed with laser-doppler spectrophotometry     system in septic patients on ICU. Microcirculatory oxygen uptake will be checked for     prognostic value and for associations with tissue hypoxia markers and high central venus     saturations.   "
64232|NCT02444910|"     KDT501 is an orally administered product designed to help control impaired glucose and     insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate     agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein     receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin     sensitivity and glucose regulation as well as reduce proinflammatory signals. These     properties combined with antihyperglycemic activity and modest, partial agonist effect of     KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARγ) receptor suggests an     atypical and pleiotropic mechanism of action for KDT501.      Following providing informed consent, potential subjects will undergo screening procedures to     ensure that they meet all inclusion and exclusion criteria. Following registration on study,     subjects will undergo baseline pretreatment studies, including two abdominal fat biopsies,     one taken after cold challenge, as well as determination of resting metabolic rate, a 4 hour     lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment studies in     registered subjects will be performed within 7 days prior to initiating therapy. On the first     day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in the clinic,     followed by serum pharmacokinetic (PK) samples being obtained every hour for 6 hours after     dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice daily. All doses     will be taken with meals (breakfast and dinner). On Day 7, subjects will return to the clinic     to undergo safety and laboratory assessments, including PK. On Days 14 and 21, subjects will     again return to the clinic to undergo safety and laboratory assessments. On Day 17 subjects     will return to the clinic for PK studies, as noted below. Treatment in all subjects will end     on Day 28. Rapid PK assessment of drug exposure, defined as AUC0-12h, will be performed     following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, and 12h on both Days 7     and 17. On Days 11 and 21 (±1day), based on the KDT501 drug exposure level, the subject will     be provided instructions on dose adjustments of KDT501. The maximum allowed KDT501 exposure     ceiling for all subjects enrolled is AUC0-12h = 22,500ng-hr/mL.   "
64233|NCT02444897|"     This study was designed to assess the effectiveness of epidural patient-controlled analgesia     compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic     gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain     control than IV PCA even for laparoscopic gastrectomy.   "
64234|NCT02444884|"     RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to     see how well it works in treating young patients with relapsed or refractory solid tumors   "
64235|NCT02444871|"     The purpose of this study is to evaluate the effect of IgM-enriched immunoglobulins     (Pentaglobin) on the endotoxin activity, conventional coagulation parameters, viscoelastic     and aggregometric measurements of patients with severe sepsis.   "
64236|NCT02444858|"     Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell     (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single blind,     controlled prospective study.   "
64237|NCT02444845|"     The purpose of this study is to evaluate the prevalence of Chronic Kidney Disease     (CKD)-related anemia at an early stage through screening of high-risk patients in Pakistan at     the level of physicians, cardiologists, and diabetologists. The information gathered may     serve as a foundation in formulating national guidelines for better early diagnosis and     management of patients with CKD.   "
64238|NCT02444832|"     Based on the anatomical features of the anterior Communicating artery complex, the     investigators will analyze the outcome of the ACoA aneurysms treated by endovascular therapy.      The most common site of intracranial aneurysms is the anterior communicating artery (AcomA).     AcomA aneurysms account for approximately one-fourth of all intracranial aneurysms.      Recent publications have addressed specifically the endovascular treatment of AcoA aneurysms.     Furthermore, detailed anatomic characteristics and the effects of the multiple variations of     the anterior communicating artery complex have scarcely been reported.      The hemodynamic factors play a fundamental role in the adequate treatment of aneurismal     coiling.      The objective of our registry is to analyze the impact of morphological configuration of the     anterior communicating artery complex and the results of coil embolization in AcoA aneurysms   "
64239|NCT02444819|"     A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of     HM61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR     mutation   "
64240|NCT02444806|"     The study aims to compare 2 different strategies used to setup non-invasive ventilation in     patients with OCPD-OSA overlap.   "
64241|NCT02444793|"     This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the     maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D)     investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with     advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761     is estimated (dose finding), one or more expansion cohorts of patients with selected advanced     solid tumors (dose-expansion ) will be enrolled to further characterize the combination in     term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and     biomarkers modulation.   "
64242|NCT02444780|"     Earlier studies showed that a low glutamine level at acute admission on the ICU is associated     with a poor outcome [3,4]. Recently, we found that a low plasma glutamine is correlated with     severity of illness and presence of an infection after non-elective ICU admission [5,     submitted].   "
64243|NCT02444767|"     The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the     ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma     or ocular hypertension.      This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in     healthy (non-glaucoma) subjects.   "
64244|NCT02444754|"     This pilot research trial studies minority patients receiving care at the Comprehensive     Cancer Center of Wake Forest University (CCCWFU) to see what their attitudes are regarding     the healthcare they receive and how much they know about clinical trials. Clinical trials are     an important way to test healthcare treatments and need diverse participants to be most     effective. Studying what minority patients think about healthcare and clinical trials may     help researchers learn more about why minorities are less likely to enroll in clinical trials     and create programs to help increase their enrollment.   "
64245|NCT02444741|"     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of     the combination of Keytruda (pembrolizumab, also called MK-3475) and radiation therapy     (either conventional or stereotactic body radiation therapy [SBRT]). The safety of this     combination will also be studied.      The goal of Phase 2 of this study is to learn if this combination therapy can help to control     metastatic NSCLC.   "
64284|NCT02444234|"     The proposed study is designed to characterize the pharmacokinetics of intravenous and oral     tedizolid in patients with Cystic Fibrosis.   "
66241|NCT02418650|"     A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance     and routes of excretion of ODM-201 in healthy volunteers.   "
64247|NCT02444715|"     Stroke is one of the most frequent and life-threatening diseases in Europe. About four stroke     events occur per day in Luxembourg alone, and about 30% of these patients are affected by     recurrent stroke within the following five years. Thus, new methods of primary and secondary     prevention are needed to better control lifestyle-related risk factors.      The development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition,     moderate physical exercises etc.) is a major objective concerning the primary and secondary     prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based lifestyle     coaching system developed by researchers from the Public Research Centre (CRP) Henri Tudor in     Luxembourg in collaboration with neurologists from the Centre Hospitalier de Luxembourg     (CHL), which aims at supporting patients in performing appropriate behavior changes in order     to minimize their individual risk factors. Patients can access CAPSYS by dialing a local-rate     telephone number and answer to a set of previously known questions concerning their current     nutrition, physical activity, blood pressure, smoking etc. In an interactive voice response     approach, questions are issued by the system in natural language using text-to-speech, and     the patient can provide the required values using the phone keypad. Based on the gathered     values for each patient, the system automatically generates personalized verbal feedback at     runtime and presents it to the patient during the phone dialog. Depending on the individual     development of the patient's risk factors, the system feedback can contain advice for     improvement, praise for healthy behavior and motivation to pursue a certain goal.      The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month     randomized controlled study with participants recruited at CHL's neurology department.   "
64248|NCT02444702|"     The long term goal of this project is dual fold. First, the investigators wish to derive,     validate and then test the impact of a clinical prediction rule to determine which patients     who suffer from CLBP with degenerative changes of the lumbar spine and referred pain to the     legs are likely to require surgery and have successful outcomes in the long term. Second, the     investigators would like to establish robust methodology and statistical analysis guidelines     for creating clinical prediction rules in physical therapy research. This observational     cohort project is a first step towards those goals. Here the investigators specifically aim     to identify personal, behavioral, psychological, morphological, and physical factors that can     predict the need for surgery as well as level of participation restriction in patients who     suffer from CLBP with degenerative conditions of the lumbar spine and referred pain to the     legs. The investigators will also explore which parameters can predict success after 1 month,     6 and 12 months in patients who underwent decompression/fusion surgery.   "
64249|NCT02444689|"     The purpose of this study is to evaluate the effectiveness of a technology-based behavioral     Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean     clinic systolic BP), and heart size (LVM) in comparison to standard care.   "
64251|NCT02444663|"     X-rays are the most frequently used imaging test when evaluating the knee for joint     replacement. They are non-invasive, safe and cost effective. They allow assessment of:     progression of disease, appropriateness for joint replacement (in particular unicompartmental     knee replacement (UKR)) as well as likely prognosis following replacement.      Currently standard assessment involves: standing anteroposterior, lateral and skyline X-ray     views. In addition in patients being considered for joint replacement valgus/varus stress     X-rays are used to evaluate the lateral compartment (as well as medial collateral ligament)     and medial compartment respectively to assess the status of the cartilage. Stress X-rays     require the clinician to attend X-ray, often during busy clinics, exposing them to additional     radiation, and as such they are seldom performed.      A patient and user friendly device for performing valgus and varus stress X-rays of the knee     for diagnostic and pre-operative planning purposes in the setting of knee replacement surgery     has been developed. This device has the potential to benefit patients as it will allow an     accurate assessment of the pattern and severity of arthritis affecting their knee without the     need for additional diagnostics such as MRI or arthroscopy. Furthermore for healthcare     practitioners and providers this device will facilitate the smooth running of clinics and     reduce the additional clinic appointments required to review MRI results. Ultimately this     device will allow an informed discussion about treatment options, reduce the pre-operative     uncertainty about suitability for UKR in those undergoing surgery and ensure that those     patients who are suitable for UKR benefit from this procedure. This device will help ensure     that patients receive the optimum treatment in a clinically and cost efficient manner.      This study will validate valgus and varus stress X-rays performed using the investigators'     device against the gold standard of clinician performed manual stress.   "
64252|NCT02444650|"     Optically-based data will be compared to tonometry to determine correlation of pulse wave     velocity measurement.   "
64253|NCT02444637|"     Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA & HSA, is     authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type.      In this trial, the investigators will be studying the effectiveness of Rivastigmine in     subjects with AD and cerebrovascular disease.   "
64254|NCT02444624|"     The clinical study involves a French network of 20 neonatology centres created as part of the     EPIFLORE project. Investigators propose including all premature babies with confirmed     necrotizing enterocolitis (NEC) diagnosis (Bell stage II or III) paired with a control group     of healthy premature babies, over a 2-year period. The clinical data will be entered at     inclusion until departure from the department, and the ASQ (Ages and Stages Questionnaires)     will be collected after 24 months. Samples from NEC cases and from the control group will be     submitted for microbiological testing by culture and pyrosequencing. This will enable the     main aerobic micro-organisms in the dominant and subdominant intestinal microbiota to be     isolated. This case-control study will be used to compile a collection of clinical and     microbiological data, in order to confirm the role of bacteria in the pathophysiology of NEC,     and to confirm the involvement of bacteria from the Clostridium genus in particular.   "
64256|NCT02444598|"     There is a treatment method called negative-pressure wound therapy (NPWT) that is well     established and used for the treatment of wounds. The method involves the application of a     wound dressing through which a negative pressure is applied. Due to a plastic film overlaying     the wound the risk of wound contamination is reduced. NPWT is considered to promote wound     healing and prevent infection and has previously been used in the treatment of acute war     associated wounds with satisfactory results. The aim of this study is to compare NPWT with     conventional wound dressings in the treatment of war-associated extremity wounds and evaluate     which method is more effective.   "
64288|NCT02444182|"     Some probiotics have been shown to have preventive effects on infectious diseases and     allergies. Because their long-term enhancement of the immune responses of children, they have     been recommended for infants in some countries. The most promising ones seem to be the     combination of Bifidobacterium lactis BB-12 and Lactobacillus rhamnosus GG. Probiotic     microbes are mainly ingested orally and the gastrointestinal tract is thus the primary target     organ for them. However, the mouth is the first part of the gastrointestinal tract. Most     probiotics are in theory cariogenic, thus their effects on oral health should be known.     Several probiotics decrease levels of salivary mutans streptococci (MS), but in other     respects very little is known about their effects on the oral microbiota. Also effects of     probiotics on dental plaque should be studied. This study aims to find out the effects of the     combination of BB-12 and LGG, delivered with a lozenge (4 weeks, twice a day) with a mixture     of them on the amount of plaque and gingival health   "
64257|NCT02444585|"     The overall objective of the proposed study is to quantify bone loss around non-cemented     total hip replacement femoral and acetabular components using DEXA analysis in patients     receiving Prolia (denosumab) in the first year of follow up after total hip joint replacement     surgery, and to compare this to bone loss in control hip replacement patients receiving a     placebo.      The primary outcome variable will be the difference in loss of bone mineral density between     the experimental group taking denosumab and the placebo control group, calculated as a     percentage, in Gruen Zone 7, the proximal medial calcar region of the femur, over a follow-up     period of 12 post-operative months.      The secondary objectives will be to assess the following variables:        -  Bone turnover differences between the experimental group taking denosumab and the          placebo control group, utilizing serum C-terminal cross-linking telopeptides of type I          collagen (CTX-I) (bone resorption) and N-terminal propeptides of type I procollagen          (P1NP) (bone formation).        -  Difference in loss of bone mineral density between the experimental group taking          denosumab and the placebo control group, calculated as a percentage, in each of Gruen          Zones 1 through 6, periprosthetic femur.        -  Difference in loss of bone mineral density between the experimental group taking          denosumab and the placebo control group, calculated as a percentage, in each of DeLee          and Charnley's Zones 1 through 3, periprosthetic acetabulum.      Exploratory objectives will be to assess difference in loss of bone mineral density in the     contralateral, or non-operated femur for both experimental and control groups, and to     determine the role that covariates such as weight, gender, age, baseline BMD, and implant     type have on percent change in BMD at 12 months.   "
64258|NCT02444572|"     Comparison of thromboembolic events between Enoxa® and Lovenox® in patients undergoing     digestive cancer and subjected to thromboprophylaxis.   "
64259|NCT02444559|"     The aim of this trial is to investigate if clonidine prolongs the duration of an adductor     canal block. By using healthy volunteers the investigators can perform a bilateral adductor     canal block and thereby control for a systemic effect to clarify if the effect is actually     peripheral or systemic. The investigators hypothesis is that clonidine/dexmedetomidine as an     adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a     peripheral mechanism.   "
64260|NCT02444546|"     This phase I trial studies the side effects and the best dose of wild-type reovirus (viral     therapy) when given with sargramostim in treating younger patients with high grade brain     tumors that have come back or that have not responded to standard therapy. A virus, called     wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells     without damaging normal cells. Sargramostim may increase the production of blood cells and     may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus     together with sargramostim may kill more tumor cells.   "
64261|NCT02444533|"     The purpose of this study is to determine whether liposomal bupivacaine (long acting     injectable anesthetic) provides greater post operative pain relief compared to the standard     post operative pain regiment for tonsillectomy patients.   "
64262|NCT02444520|"     Medically unexplained symptoms (MUS) can be defined as physical symptoms that at present have     no clear physical pathological cause. In primary care between 20 and 40% of patients have     medically unexplained physical symptoms and in secondary care this figure rises to 50% in     many specialties.      This study design is a cross over randomized controlled trial with a waiting list to evaluate     the acceptability and feasibility of studying a whole systems approach to care in general     practice for adults with PPS. 'Integrated GP care' will be compared with treatment as usual     (TAU) within a waiting list design.      The aim of this study is to assess the feasibility of conducting a future randomized trial     and to identify suitable primary outcome measures (outcomes that may be affected by     'integrated GP care'), for a future trial evaluation and to inform the sample size/power     calculation for such a trial.   "
64263|NCT02444507|"     To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in     healthy volunteers who reside in Taiwan.   "
64285|NCT02444221|"     To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at     least one additional investigator-determined risk factor for stroke in real-life practice.   "
66242|NCT02418637|"     Test the feasibility of performing worksite screening of Hypertension, Diabetes and     Hyperlipidemia for six months   "
64265|NCT02444481|"     Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial     and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information.      Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory     treatment.      Objectifs of the study:      Principal objectif:      Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or     mycotic vaginitis      Secondary objectif:      Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation     of the correspondence of the efficacy on the symptoms and on the eradication of the germs.      Numbers of patients previewed: 100 patients for evaluation of the efficacy      Criteria of evaluation      Principal criteria:      Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical     symptoms judged by the patient reduction or emlimination of bacteria and other germs the     relationship between clinical and bacterial results      Evaluation of tolerance      Used Study Drug:      Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin     100000UI Application: vaginal application once daily in the evening for 12 days      Study design:      Visit 1:      All patients presenting with the clinical symptoms, presenting all inclusion criteria and     none of the exclusion criteria are included in the study at visit 1 and receive Polygynax     treatment (one vaginal capsule once daily in the evening).      A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological     examination confirms an infection with germs sensible to the treatment with Polygynax the     treatment is continued. If other germs not sensible to Polygynax are present, the patients is     contacted to stop the treatment, to come back to a second visit to her gynacologist who will     change the treatment. The other patients continue the treatment.      Visit 3:      After the treatment the patients come back to the last visit. A clinical evaluation and a     vaginal smear for control is obtained.   "
64266|NCT02444468|"     This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic     foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to     investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby     preventing delay of surgery due to swelling.      The investigators will include patients with malleolar fractures that require surgery in two     groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.   "
64267|NCT02444455|"     Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem     cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.   "
64268|NCT02444442|"     The purpose of this study is to assess the efficacy catheter-based renal denervation in     reducing blood pressure in patients with resistant hypertension compared to a sham procedure.     Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be     switched to a single pill triple combination treatment prior to the procedure.      A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35     patients in the sham control arm.      The duration of this study is 36 months.   "
64269|NCT02444429|"     Renal transplantation represents currently the best therapeutic alternative for end-stage     renal failure, not only in terms of patient outcomes (better quality of life and longer     survival), but also in terms of costs for the society.      Progress achieved in the last 20 years has resulted in a drastic reduction of the incidence     of classic (i.e. clinically patent) acute cellular rejection episodes.      Unfortunately, and rather unexpectedly, this progress has had hardly any effect on the     frequency of the loss of kidney transplants beyond the first year, as shown by the stagnation     of grafts' half lives.      Furthermore, the use of immunosuppressant combinations that are more and more powerful has an     impact on adverse effects in recipients, including an increased incidence of infections,     cancers, but also metabolic complications (diabetes, osteoporosis, dyslipidemia, etc.), which     are cause of significant morbi-mortality.      In an attempt to improve on these disappointing outcomes, some teams have offered to perform     screening biopsies: i.e. routine biopsies at specific time points during the follow up,     irrespective of graft function. Their primary interest is to allow a pathological analysis of     the graft at an early stage, i.e. when potential histological lesions allow for a diagnosis     but before these lesions impact on graft's function. Indeed, it has been clearly demonstrated     that therapeutic adjustments intended to protect the grafts are most effective when     introduced early. There is a fairly broad consensus to perform these biopsies three months     and one year after the transplantation. Performing screening biopsies has led to the     identification of subclinical forms of rejection, i.e. graft infiltration by recipient     immune effectors meeting the Banff histological criteria, but without increase in     creatininemia.      Assuming that about 10% of screening biopsies performed at 3 months reveal a subclinical     rejection, which needs to be treated, the management strategy for the remaining 90% of     patients, whose biopsies show either i) a mild inflammatory infiltrates: i.e. borderline     changes, or ii) the complete absence of immune effectors in the graft is, poorly     standardized.      The investigators therefore propose to conduct a prospective randomized trial to answer these     questions simultaneously by evaluating a strategy to optimize the immunosuppression of renal     graft recipients based on the presence or absence of subclinical intragraft inflammatory     infiltrates in the screening biopsy performed at 3 months post transplantation. Patients with     borderline changes (sub-study A) will be randomized to receive a treatment for rejection     (corticosteroid boluses). Patients without inflammation in their graft (sub-study B) will be     randomized for corticosteroid withdrawal. Impact on graft function, progression of     histological lesions and incidence of morbidity will be evaluated.   "
64270|NCT02444416|"     Context:      Heart failure is associated with a high morbidity and mortality rate and represents a     significant worldwide public health burden. In European countries, the total amount of the     expenses related to heart failure represents 1 to 2% of the total health budget with 75%     spent during hospitalizations, making heart failure the most expensive pathology in     cardiology. Acute heart failure (AHF) has a poor prognosis despite improvements in therapy.     Hospital mortality is 2 to 4% the risk of death or readmission in the six months following     hospitalization is high.      Patients hospitalized for heart failure represent a very heterogeneous population in terms of     etiologies, clinical presentations and/or co-morbidities. Consequently, this implies variable     outcomes in terms of morbidity and mortality, probably due to their different prognostic     factors. The precise spectrum of etiologies and prognostic factors of AHF in non selected     populations has not been exhaustively studied and only a few predictive models concerning AHF     have been validated.      Ischemic heart disease, valvulopathy, arrhythmias, infections, hypertension and lack of     therapeutic compliance are often quoted as being the factors triggering heart failure. Some     triggering factors (ischemic heart disease, pulmonary infections, acute renal failure) seem     to be strongly associated with a poor prognosis in terms of hospital/out-patient mortality     and re-hospitalization rate.      The complex relation between heart failure and acute renal failure is defined by the     cardio-renal syndrome. Thirty percent of patients hospitalized for AHF will be diagnosed with     an acute renal failure at admission or with worsening kidney failure during hospitalization.     It seems that heart failure and cardio-renal syndrome are two distinct entities with a     different prognosis. The type of acute renal failure (functional, renal or post-renal) in     these patients and the prognostic value of these etiologies is still not firmly established.      A thorough determination of the etiologies and prognostic factors of AHF are necessary in     order to allow the identification of high-risk patients and the improvement of heart failure     management.      Objectives:        -  To create an observational registry of all patients hospitalized for a AHF        -  To determine the precise prevalence of etiologies and the prognostic factors of AHF in a          non selected population. Among the prognostic factors, to establish the specific role of          acute renal failure        -  To establish the optimal initial assessment of patients hospitalized for heart failure        -  To validate and compare with prospective data the results of a retrospective cohort          study carried out at the University Hospital of Geneva who established the          re-hospitalization and mortality outcome of patients hospitalized for heart failure.      Method:      Creation of an observational registry associated with a biobank including patients     hospitalized for AHF in the Department of General Internal medicine (SMIG) and in the     Departments of Specialties at the University Hospital of Geneva.      Anticipated results:        -  To identify the prevalence of the etiologies and the prognostic factors of the heart          failure        -  To establish the optimal initial assessment of the patients hospitalized for a heart          failure. Among the prognostic factors, to establish the specific role of acute renal          failure        -  To validate and compare results of a retrospective cohort study carried out at the          University Hospital of Geneva which established the re-hospitalization and mortality          outcome of patients hospitalized AHF        -  To improve the management of hospitalized patients with AHF with a robust identification          of the etiologies and a better identification of high-risk patients.   "
64295|NCT02444091|"     Significant clinical improvements of ME/CFS symptoms were observed in two patients with     long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast     cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for     Hodgkin lymphoma.      Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks     apart, in two of these with a significant clinical response.      The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that     ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse     infusions four weeks apart, six infusions in total.      The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as     intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS     symptoms and tolerability/side effects during 12 months follow-up will be registered, and     additional tests will be performed to objectively register changes in physical ability during     follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin     microvascular dysfunction will be performed before start of intervention and during     follow-up.   "
64271|NCT02444403|"     Background: Policing practices are key drivers of HIV among people who inject drugs (PWID).     This study prospectively examines the impact of a police education program (PEP) to align law     enforcement and HIV prevention. PEPs incorporating HIV prevention, (including harm reduction     programs like syringe exchange) have been successfully piloted in several countries but were     limited to brief pre-post assessments; the impact of PEPs on policing behaviors and     occupational safety is unknown. Objectives: Proyecto ESCUDO (Project SHIELD) aims to evaluate     the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the     incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of     transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID,     adverse behaviors that interfere with HIV prevention, and protective behaviors (secondary     outcomes). The investigators hypothesize that, over the course of the 24-month follow-up, the     PEP will be associated with significant declines in NSI incidence, improved knowledge of HIV     and related infections, uptake of occupational safety measures, and decreases in behaviors     that undermine HIV prevention (e.g. syringe confiscation, police harassment of PWID at opioid     substitution therapy and syringe exchange programs). Methods/Design: ESCUDO is a Hybrid Type     2 design that simultaneously tests an intervention and an implementation strategy. Using a     modified stepped-wedge design involving all active duty street-level police officers in     Tijuana (N= ~1200), the investigators will administer one 3-hour PEP course to groups of     20-50 officers until the entire force is trained. NSI incidence and geo-coded arrest data     will be assessed from department-wide de-identified data. Of consenting police officers, a     sub-cohort (N=500) will be randomly sampled from each class to undergo pre- and post-PEP     surveys with semi-annual follow-up for 2 years to assess self-reported NSIs, attitudes and     behavior changes. Impact on PWIDs will be externally validated through a parallel cohort of     Tijuana PWIDs. Discussion: This is the first trial to assess efficacy of a PEP on policing     behaviors that place PWID and police at elevated risk of HIV and blood-borne infections.     Findings may help bring PEPs to scale in the growing number of countries where policing is a     documented driver of HIV acquisition.   "
64272|NCT02444390|"     This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit     from treatment with everolimus in patients who are eligible for everolimus+exemestane     treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane     are prescribed within their approved indication as per usual practice and are not part of     this trial.   "
64289|NCT02444169|"     A retrospective study to evaluate the Ulthera® System for its potential interaction with     toxins and fillers. Up to 500 subjects will be enrolled.   "
65951|NCT02422433|"     The purpose of this research is to test the feasibility, sensitivity, and specificity of the     marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus     (BE).   "
64273|NCT02444377|"     Purpose: The purpose of this study would be to evaluate the effects of interval training on     cardiovascular health, lipid profile and body composition in overweight and obese men and     women.      A secondary purpose will be to compare lab based measurements of body composition     [4-compartment model (4C)) with portable equipment [bioelectrical impedance spectroscopy     (BIS) and ultrasound (US)]      Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly     assigned to a high-intensity short interval group (SIT), high-intensity long interval group     (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak     oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will     also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA),     air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants     assigned to either training group will undergo 3 weeks of interval training, 3 days per week.     SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the     power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same     protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power     output).   "
64274|NCT02444364|"     Participants will be persons with Type 2 Diabetes who are likely to have increased risk of     bone fractures. The investigators believe this medication will enhance bone turnover.      The investigators will use DXA measurements to evaluate bone density before and after     subjects take the medication.   "
64275|NCT02444351|"     Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The     purpose of this study is to evaluate the effect of botulinum toxin A injection into the     gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We     will compare pain score, insomnia severity, functional ability, patient satisfaction, and     neurophysiological variables change using electrical stimulator between control (conservative     management for spinal stenosis) and botox group (conservative management for spinal stenosis     plus botox injection into the gastrocnemius muscle).   "
64276|NCT02444338|"     To study the safety and effectiveness of the MitraClip System in the treatment of clinically     significant functional mitral regurgitation in patients with New York Heart Association     (NYHA) Functional Class II to Class IV chronic heart failure.   "
64277|NCT02444325|"     The investigators primary objective is to conduct a pilot randomized trial to determine the     effect of group prenatal care on self-care activities in women with diabetes.   "
64278|NCT02444312|"     A randomised controlled trial that will compare the effects of a brief benefit -finding     writing intervention with an active control condition on quality of life and psychological     health among informal caregivers.   "
64279|NCT02444299|"     Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for     the treatment of various shoulder pathologies. It received CE Mark in June 2007.      The aim of this study is to collect immediate medium and long term data on performance and     safety of the implant, retrospectively as well as prospectively, from a consecutive series of     patients to assess the patients' outcomes and functional status.   "
64280|NCT02444286|"     To evaluate the safety and efficiency of the MitraClip system in the treatment of patients     with clinically significant mitral regurgitation with New York Heart Association (NYHA)     Functional Class II to IV chronic heart failure.   "
64281|NCT02444273|"     The primary outcome of this study is to demonstrate the feasibility of a prehabilitation     program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent     to participate in the study and are placed on the transplant list will be randomized into     either the control or intervention group. The intervention group receives a personalized home     exercise program along with weekly phone calls to provide coaching, mentoring and motivation.     Data collected at baseline, post-transplant and, post-transplant follow up will be compared     among the two study groups. The secondary outcomes include: normative data of functional     measures for patients with end stage liver disease and to determine the effect size for     future research on prehabilitation in the patient population.   "
64282|NCT02444260|"     The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local     Anaesthesia alone versus Local Anaesthesia and Conscious Sedation      Specific study objectives are to determine the effect of conscious sedation on:      (i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative     complications (v) postoperative functional status (vi) short-term postoperative complications     (vii) long-term postoperative complications   "
64283|NCT02444247|"     The purpose of this study is to understand how to make exercise more attractive to people.   "
64286|NCT02444208|"     Cocaine abuse is an unrelenting public-health concern. Behavioral therapies are considered     the standard of care for reducing cocaine use and preventing relapse. However, even with     intense behavioral interventions, rates of relapse to cocaine use are discouragingly high     (i.e., 60-95% of patients return to drug use). Novel strategies are urgently needed to     improve treatment outcomes for cocaine-use disorders. The overarching goal of this project is     to assess the feasibility, acceptability and initial efficacy of an innovative cocaine-based     inhibitory-control training procedure. This goal will be accomplished through the conduct of     a Stage I pilot trial. Cocaine-dependent participants will be enrolled and randomized to     receive inhibitory-control training to cocaine or neutral images (N=20/condition). This     proposed intervention, cocaine based inhibitory-control training, will be delivered using an     innovative computer program which teaches cocaine abusers to inhibit a pre-potent response to     cocaine or neutral cues. The primary hypothesis is the proposed procedures are feasible and     acceptable to the participants. Feasibility will be assessed by determining time needed to     enroll the target sample; adaptive randomization outcomes; participant attendance, completion     and adherence to study procedures. Acceptability will be determined using a Treatment     Acceptability Questionnaire. The secondary hypothesis is that participants receiving     cocaine-based inhibitory-control training will reduce their drug use to a greater extent than     their counterparts in the neutral-image condition. Reduced cocaine use will be demonstrated     by fewer positive-urine samples using qualitative urinalysis and a reduction in levels of     benzoylecgonine as determined by quantitative urinalysis (i.e., ELISA). The third hypothesis     is that participants receiving cocaine-based inhibitory-control training will show improved     inhibitory control and neurocognitive functioning relative to their counterparts in the     neutral-image condition. Improved inhibitory control, impulsivity and cognitive functioning     will be demonstrated using a battery of clinical instruments and laboratory tasks. The     proposed research is highly innovative in that it will provide critical information regarding     the feasibility, acceptability, initial efficacy of cocaine-based inhibitory-control training     to reduce drug use and improve inhibitory control and neurocognitive functioning in     cocaine-dependent participants. Cocaine-based inhibitory control training is also easy to     administer (i.e., 15 minutes), inexpensive, need not be administered by a clinician, and     could easily be incorporated into current behavioral or community-based treatment approaches     to enhance sustained abstinence, thereby quickly impacting clinical research and practice.   "
64287|NCT02444195|"     The purpose of this study is to evaluate the effectiveness of self-administered perioperative     guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing     surgical management for a presumed cancer diagnosis.   "
64302|NCT02444000|"     Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of     neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk     of neurocognitive deterioration without impairing overall survival.   "
64290|NCT02444156|"     Primary research question: What is the effect of indoor rowing, under the ideal circumstances     of a laboratory setting, on glucose control in adults with impaired glucose control?      Secondary research question: Is it possible to develop a full-scale study of the benefits of     indoor rowing under the usual circumstances of a community setting?      Why? It is good practice to conduct a small pilot study before embarking on an expensive     full-scale study.      What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise     per week are necessary to meet prevailing recommendations for adults with impaired glucose     control. Around 120 minutes of indoor rowing per week might be a less time-consuming     alternative to prevailing recommendations because indoor rowing involves a combination of     aerobic and resistance exercise.      Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation,     such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last     year, will not have exercised regularly in the last six months, and will not be taking any     form of diabetes medication other than metformin. Eligible volunteers will have stable weight     and a body mass index of 25-40.      Where and how? Before and after the exercise intervention, glucose control (postprandial     blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac     function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention,     participants will use an indoor rower three times per week for 12 weeks at Leicester Diabetes     Centre. Participants will be taught how to row correctly and the duration and intensity will     gradually increase. In order to inform the design of a full-scale trial, recruitment rate     will be assessed, adherence will be monitored, and a third party will interview participants     to find out if the intervention and assessments are feasible and acceptable.   "
64291|NCT02444143|"     Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day     dosing regimen. This formulation has the potential to improve compliance. Current dosing     recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day     administered once daily in the morning. There are no specifications on appropriate dosing in     obese patients or on whether to use actual, ideal or and adjusted weight. It will be     advantageous to understand the pharmacokinetics of this medication in the obese to determine     the appropriate dosing regimen. In this study, obese patients will be randomized to receive     tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or     adjusted body weight (aBW).   "
64292|NCT02444130|"     The main purpose of this study was to identify electrophysiological predictive markers of     post-correction visual comfort for presbyopic patients.   "
64293|NCT02444117|"     This study aims to identify clinical and biological markers which would allow to evaluate     precisely the evolution of children with autism spectrum disorders throughout intervention.   "
64294|NCT02444104|"     To evaluate and to validate accuracy, precision and trending ability of blood pressure and     cardiac output measurement by applanation tonometry in cardiological patients having:        -  atrial fibrillation        -  severe impaired leftventricular function        -  severe aortic valve stenosis        -  patients having left ventricular assist device      Experimental measurement: continuous blood pressure measurement and cardiac output     measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA)     Control measurement: gold-standard continuous blood pressure measurement is performed by     invasive blood pressure measurement by arterial cannulation and cardiac output reference is     assessed by transcardiopulmonary thermodilution   "
64296|NCT02444078|"     This is a cluster randomised controlled trial composed of two research arms: exercise     training group (experimental group) and a social activity group (control group).   "
64312|NCT02443870|"     The long-term changes of bladder function in individuals with lower urinary tract dysfunction     will be investigated. Patients presenting for regular urodynamic examination of bladder     function will be included. Bladder diary details and urodynamic data will be collected in     order to investigate bladder function.   "
64313|NCT02443857|"     The purpose of this study is to investigate the applicability and feasibility of the newly     developed robot platform for upper extremity therapy (ChARMin) in children undergoing     neurorehabilitation.   "
64314|NCT02443844|"     The purpose of this study is to compare medical and surgical treatments of benign prostate     hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and     progression.   "
64297|NCT02444065|"     Treatments for bulimia nervosa (BN) have relatively high rates of nonremission and relapse,     meaning that improving treatments is a high priority in this area. Rapid response to     treatment -cessation of binge eating and vomiting symptoms within the first weeks of     treatment - is a robust predictor of improved post-treatment outcomes and lower relapse     rates, but no study has tried to facilitate rapid response as a means of improving treatment     outcomes. The present study responds to this gap in the literature by testing a 4-session     CBT-based individual intervention for rapid response (i.e., CBT-RR), designed to augment     standard day hospital (DH) treatment for BN and Purging Disorder (PD) by focusing on     strategies and skills for rapid symptom interruption. CBT-RR will be compared to a     matched-intensity augmentative motivational interviewing (MI) intervention. Participants will     be recruited from a hospital-based day program for eating disorders, and will be randomly     assigned to one of the two conditions in addition to the DH as usual. participants will be     assessed at pre-intervention, post-intervention, week 4 of DH, post-DH, and 6 months     follow-up. It is hypothesized that compared to those who receive MI, patients who receive     CBT-RR will be more likely to exhibit a rapid response to day hospital treatment (i.e., </= 3     binge eating and/or vomiting episodes in the first 4 weeks). It is further hypothesized that     patients who receive CBT-RR will exhibit fewer binge eating and/or vomiting episodes at     post-DH and at 6-month follow-up. Potential mediators and moderators of these hypothesized     treatment effects will be examined on an exploratory basis, including self-efficacy,     motivation, and hope (potential mediators), and emotion regulation, depression, cognitive     psychopathology of eating disorders, and working alliance with the therapist (potential     moderators).   "
64298|NCT02444052|"     The purpose of this study is to evaluate clinically, histologically and radiographically the     healing of extraction sockets with Zimmer's Puros® allograft compared to creos™ (creo™ Nobel     Biocare,), a low-cost allograft material, 90 days following exodontia.   "
64299|NCT02444039|"     The objective of the study is to compare the ease of use and performance of the SL-D301 with     the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.   "
64300|NCT02444026|"     The aim is, in a randomized controlled trial, to test the feasibility and evaluate the     efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US     cancer patients, in a large sample of Danish breast cancer survivors who are experiencing     significant sleep problems 0-3 years after treatment. The investigators aim to test the     following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy     (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep,     fewer awakenings during the night, improved sleep efficiency, increased subjective sleep     quality, and improved quality of life after the intervention, when compared to a waiting list     control group. The investigators also aim to explore a number of possible moderators of the     effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and     mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).   "
64301|NCT02444013|"     The purpose of this study is to determine whether periprocedural administration of folic acid     is effective in the prevention of contrast induced nephropathy in patients undergoing     coronary CTA/angiography/angioplasty.   "
64304|NCT02443974|"     Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the     most commonly affected joint in this population. Knee braces are often used to prevent common     problems in knees during daily activities. The purpose of these devices is to decrease pain     and improve functionality. In the literature some studies have tested the effectiveness of     unloader brace for valgus or varus. However, the braces most used in the investigators'     clinical setting and the less costly ones have not been described in quality studies in the     literature. There are only few studies on this subject and they are methodologically     inadequate. There are no studies that compared the effectiveness between the knee brace with     metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the     effectiveness of knee braces on pain, function and quality of life in the elderly with knee     OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric     scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were     randomized to the groups: without metal hinges, with metal hinges or control group. The     groups without and with metal hinges received knee brace and were instructed to use it in     daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC     and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180     days by a blinded assessor.   "
64305|NCT02443961|"     Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth,     15-50% of very low birth newborns (<1500 gr.) will develop BPD. The prevalence of BPD is     increasing due to the advances in neonatology, with a rise in the survival of smaller and     more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal     chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These     factors lead to a pathological development of the lung and pulmonary vessels, developing     secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this     generates a important sanitary burden and a decrease in life quality. Multiple experimental     models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also     recently some clinical trials have tried this therapy on premature newborns with promising     results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions.     Methods: The investigators have designed a clinical trial to evaluate the feasibility and     security of MSC therapy in patients at high risk of developing BPD.   "
64306|NCT02443948|"     This observational study is proposed to evaluate if the trend in the levels of cf-DNA     evaluated on a sample of peripheral blood may be related to different clinical behaviors of     the disease monitored by radiological investigations conducted.   "
64307|NCT02443935|"     Combination antiretroviral treatment (cART) effectively suppresses virus replication and     partially restores immune functions. However, cART cannot cure HIV infection.      This study aim to investigate whether the antiviral immune response can be enhanced and/or     viral transcription reactivated with MGN1703. MGN1703 is an agonist to toll-like receptor     (TLR) 9. Activation of TLR9 has been shown to augment innate and adaptive immune effector     functions, most notably enhanced NK cell and T cell functions.      Furthermore, TLR9 agonists have been shown in vitro to reactivate viral transcription in     latently infected cells, potentially leading to enhanced recognition of infected cells by the     immune effector cells.   "
64316|NCT02443818|"     It was found that people who have an excessive growth in one or more parts of their body and     normal growth in other parts, may have a change in genes responsible for controlling cell     growth. This genetic discovery identified a possible treatment for this overgrowth, called     Sirolimus.      This is a pilot study, which help the investigators prepare a larger international study,     which will aim to determine whether a treatment based Sirolimus is able to stop the excessive     growth of one or more parties of their body in people who carry a genetic change in the     PIK3CA gene (phosphatidylinosilol-3-kinase encoded by the gene PIK3CA).   "
64317|NCT02443805|"     The objective of this study is to assess the efficacy and safety of 12 months of treatment     with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with     HDM-associated allergic rhinitis.   "
64318|NCT02443792|"     RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical     circumcision under local anesthetic with suturing.   "
64319|NCT02443779|"     The purpose of this study is to examine if a correlation exists between findings from brain     imaging studies of the status of the dopamine system in the brain using DaTscan and SPECT     imaging, clinical symptoms of Parkinson's disease, and changes in the structure of the retina     as detected by optical coherence tomography (OCT) in recently diagnosed and more advanced     Parkinson's disease patients.   "
64320|NCT02443766|"     Over 2 decades scientists have been studying the effect on brain function from meditation     practices. The purpose of this study is to measure the effect of a meditation retreat program     on serotonin and dopamine transporter binding and changes in cerebral blood flow. The retreat     program that will be followed is a weeklong retreat called the Ignatian Retreat.   "
64321|NCT02443753|"     This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and     obese subjects with type 2 diabetes. The barbless second generation device is being developed     as a means to reduce the incidence of adverse events associated with the barbs of the     predicate device while maintaining a similar efficacy profile as measured by changes in     weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human     will primarily evaluate preliminary safety, tolerability and efficacy of the new design.     Because of the new design and its first study in human subjects, only a 3 month implant     duration will be evaluated in this study.   "
64322|NCT02443740|"     This is a First in human (FIH) single ascending dose study to evaluate the safety,     tolerability and pharmacokinetics (PKs) of PF-05251749 following single oral doses in healthy     human subjects   "
64356|NCT02443285|"     Current European and most other international guidelines recommend the use of a     third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or     fluoroquinolones as an alternative choice .      These recommendations are based mainly on clinical trials that were very often conducted a     decade or more ago, and on the assumption that E. coli would be involved in nearly half of     the cases.      The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance     rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime),     ciprofloxacin, and ofloxacin increased dramatically .   "
64323|NCT02443727|"     The main objective of this project is to study whether intranasal oxytocin (OT) affects how     young adults perceive and attend to infant and adult faces. Based on existing research the     investigators predict that oxytocin will facilitate the allocation of attentional resources     on infant faces (compared to adult faces). The investigators also predict that oxytocin will     enhance the activity of reward neural-networks associated with the perception of infant     faces. The behavioral effects of OT (visual attention and face recognition) will be measured     with eye-tracking while participants look at photographs of adult and infant faces.     Neurological effects (the activity of emotion and reward networks) will be measured with     functional Magnetic Resonance Imaging (fMRI) while participants look at infant faces on a     computer screen.   "
64324|NCT02443714|"     Needle-free jet injector provides an alternative for patients with diabetes treated by     insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD)     profiles of lispro administered by jet injector and conventional pen.   "
64325|NCT02443701|"     Background: Volleyball players constantly perform vertical jumps, the higher the height of     the jump is better sports performance of these players. Several methods have been tested to     improve jumping performance in these players. It will be investigated the addition of     electrical stimulation and phototherapy to jump training in volleyball athletes. DESIGN:     randomized controlled trial. METHODS: This study will be conducted with 36 male athletes     volleyball with minimum experience of 12 months sport. Will be randomized and assigned to 3     groups (control group, NEMES group and group phototherapy). All 36 healthy volleyball     athletes who passed the initial selection and agreed to participate in the study, conduct a     muscle strength and jump training program, which is held in both legs simultaneously. The 12     healthy athletes electrical stimulation group will perform the same training program     described above, but strength training is associated with electrical stimulation. The 12     healthy athletes participating in the phototherapy group will undergo a phototherapy protocol     before performing the strength and jump training. All selected participants will undergo an     assessment of muscle strength of knee extensors and evaluate the jump. These evaluations were     baseline, 6 weeks and 8 weeks after baseline.   "
64326|NCT02443688|"     This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the     safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.   "
64327|NCT02443675|"     Observational Study of Pain Reduction in Late Stage Cancer Patients Receiving Low-Dose     Chemotherapy   "
64328|NCT02443662|"     Children born with univentricular heart will go through step surgery and end up with a Fontan     circulation. A circulation with cause problems with body fluid balance.This project will     evaluate changes in interstitial colloid osmotic pressure in patients 10 year after     completion of a three step Fontan surgery. This project will evaluate whether increased micro     vascular leakage and change in interstitial colloid osmotic pressure are present in patients     after ten years with a Fontan circulation.   "
64348|NCT02443389|"     Introduction:      Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level     neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI     have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK     sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized     the need to improve collaborations between neonatologists and nephrologists within and across     centers. The investigators have created a multi-institutional, multi-disciplinary group,     Neonatal Kidney Collaborative (NKC), in order to address the following critical needs     identified at the workshop: AWAKEN is the inaugural study of this new collaboration.        1. Development of a standardized evidence-based definition of neonatal AKI        2. Evaluation of risk factors that predispose neonatal to AKI        3. Investigation into how fluid provision/ balance impacts biochemical and clinical          outcomes   "
64329|NCT02443649|"     Insomnia is a significant problem affecting 10 to 20% of US population. Long-term     pharmacological treatments are not recommended due to side effects, with therapy and sleep     hygiene education often employed as alternatives. Use of mind-body approaches for insomnia is     increasing. One of the most promising mind-body approaches for alleviating sleep problems is     hypnosis. Research indicates significant beneficial effects of hypnosis on sleep, but sleep     was rarely assessed as primary outcome and studied populations were diverse. Further, it     remains unclear who the best candidates for benefitting from hypnosis are. To address some of     the gaps in the current knowledge, the study evaluates whether 1) an addition of hypnotic     suggestion for sleep improvement to the optimizing sleep hygiene (OSH) program increases the     effectiveness of the OSH using objective and subjective assessments and 2) determines     characteristics associated with hypnotic responsiveness.To address these goals a randomized     controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1 month     follow-up) will be conducted with 50 adults meeting criteria for primary insomnia and     allocated to one the two groups: 1) experimental group receiving during the intervention     visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for     sleep improvement and 2) a control group receiving at the intervention visit the OSH only.     Hypnosis session for sleep improvement for the control group will be offered at the end of     the follow-up study visit (conducted after 4 weeks post-intervention) after completing all     follow-up measures. Each study visit will last for 2-3 hours. During the visits sleep,     personality traits and daily function of the participants will be assessed. Further, after     the baseline and one week before the follow-up visit subjects will wear a watch-like     actigraphic device monitoring their sleep patterns at home and will complete sleep diary.      The knowledge gained from this study will inform the literature and clinicians about     usefulness of hypnosis for insomnia sufferers and will help identify the population of     insomnia sufferers most likely benefit from use of hypnosis for sleep   "
64330|NCT02443636|"     While effective interventions for depression exist, their success rates are unsatisfactory     and their provision is haphazard. The Canadian Depression Research and Intervention Network     (CDRIN) Maritimes Depression Hub will improve the delivery of care and the quality of     outcomes for youths, adults and seniors with depression across the Maritimes. The     investigators will establish an integrated system of assessment, treatment, research and     education related to depression with the active involvement of those with lived experience.     The establishment of a patient registry is a key step that will facilitate evaluation and     reform of current services, integration of patient choice and community resources into     treatment programs, monitoring long-term outcomes, and development of more effective     treatment approaches through research. The registry will facilitate research that will     include validation of new diagnostic and outcome measurement tools, low-cost clinical trials     and collaborative projects with national and international partners. Educational programs     will involve training the next generation of researchers, those with lived experience,     clinicians, and health system managers in critical appraisal and will facilitate their     involvement in research. The registry, the proposed systematic measurement of outcomes and     the broad dissemination of information and skills will improve the quality of research and of     care as well as the experience of patients and their families.      The need for a registry: It is increasingly recognized that major advances in the treatment     of mental disorders will require large scale clinical research. Recently demonstrated ways of     completing large-scale research with finite resources include the routine use of electronic     health records (EHR), data linkage and randomized registry trial. Use of EHR is the most     efficient way of rapidly obtaining large amounts of information. However, EHR cannot     completely exclude confounding by indication and other unmeasured variables. Therefore, tests     of treatment effects require experimental designs that cannot be replaced by routine health     records data. The gold standard for testing the effects of treatment in an unbiased way is     the randomized controlled trial (RCT), where measured and unmeasured confounders are balanced     through the randomization process and any remaining confounding is due to chance alone. RCTs     are valued as the highest level of evidence, but are costly and take significant time to be     completed, partly because of the need to screen a large group of individuals to identify     eligible participants.      The most efficient unbiased test of interventions, new treatment modalities and novel ways of     treatment delivery is a method that combines EHR use with the randomized controlled trial     (RCT) methodology: the randomized registry trial (RRT). The RRT takes advantage of a registry     of individuals with available information to identify a large number of individuals suitable     for an RCT. The RRT approach is efficient especially if the same information (e.g. diagnosis     and treatment history) is used repeatedly for different purposes. The same information can be     used for clinical purposes, service improvement and multiple research projects. RRT will     allow obtaining answers about the efficacy of new treatments and management strategies     significantly faster and at a much lower cost than traditional RCTs. Therefore, the     investigators propose to establish a registry that has the capacity to conduct RRTs. The     proposed registry will be integrated with similar efforts across Canada. Jointly, this     collaborative network of registries will facilitate fast and economical testing of new     treatments, which is urgently needed to advance the therapeutic options for people with     depression and related conditions.   "
64331|NCT02443623|"     Objectives:        -  To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune          response resulting in high anti-vaccinia antibody titers. The collection of donor plasma          will be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).        -  To ensure the safety of plasma donors vaccinated with ACAM2000 through the          implementation of risk factor screening procedures and the collection of          post-vaccination safety data.   "
64332|NCT02443610|"     The aim of this study is to evaluate the frequencey and the determinants of postpartum major     complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity     hospitals of Finistère (Bretagne - France)   "
64333|NCT02443597|"     Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for     aneuploidy risk assessment.   "
64334|NCT02443584|"     This is a randomized, control group design of pharmacogenetic implementation in a mental     health population of subjects taking anti-depressants and/or anti-psychotics with a new or     current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive     Disorder Not Otherwise Specified (DDNOS).   "
93784|NCT02058537|"     The primary goals of this study are to ease the symptoms of patients with Eosinophilic     Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those     symptoms.   "
64336|NCT02443558|"     CSI:Brainwave is a multidisciplinary neurophysiological project, developed by the Lab of     Medical Physics, School of Medicine, Aristotle University of Thessaloniki and supported by     two Neurosurgical Departments. The project officially commenced on April 2014 and the first     year was awarded the 2013 Mario Boni Research Grant by the Cervical Spine Research     Society-European Section (CSRS-ES). The website for the project can be accessed at     http://medphys.med.auth.gr/content/csi-brainwave.      The investigation's primary objectives include the development, testing and optimization of a     mountable robotic arm controlled with wireless Brain-Computer Interface, the development and     validation of a self-paced neuro-rehabilitation protocol for patients with Cervical Spinal     Cord Injury and the study of cortical activity in acute and chronic spinal cord injury.   "
64337|NCT02443545|"     This is a long-term follow-up to an earlier study, LA38-0411. Its purpose is to gather more     information about the safety and efficacy of deferiprone in patients with sickle cell disease     or other anemias who suffer from iron overload caused by regular blood transfusions.   "
64338|NCT02443532|"     Patients with type 1 diabetes aged 15-65 years without major complications will be randomized     either to usual care or to a structured group education program, with 6 four-hour weekly     interactive sessions devoted to diabetes management. The principal endpoint will be the     variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality of     life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.   "
64339|NCT02443519|"     This randomized clinical trial aims to examine the effect of a standardized 8-week course of     Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people     with migraine.   "
64340|NCT02443506|"     This study is to evaluate the safety of AMG 623 in subjects with systemic lupus     erythematosus. The study consists of a 21 day screening period followed by administration of     the investigational product and up to 70 day follow up period.   "
64341|NCT02443493|"     Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the     treated area, also known as radiodermatitis (RD).      Currently, there is a wide variety of strategies to manage RD, including creams, gels,     ointments, wound dressings. However, up to now, there is still no comprehensive,     evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a     promising, non-invasive technique for treating RD. In a recent pilot study conducted in our     research group, LLLT prevented the aggravation of RD and provided symptomatic relief in     patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot     study was the first prospective study investigating the potential of LLLT for RD. In the     current study, we want to investigate the efficacy of LLLT as a tool for the prevention of     radiodermatitis in breast cancer patients.   "
64342|NCT02443480|"     The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the     frequency of verbal cues, body positioning and anxiety levels with descriptions for each of     the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different     observers and to determine any correlation with patient satisfaction.   "
64343|NCT02443467|"     This was an open-labeled, multi-center, prospective, non-comparative study of the safety of     Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who     had previously received antracycline therapy before or after surgery.   "
64344|NCT02443454|"     Central blood pressure and pulse wave velocity were measured using a Complior Analyse device     in Short and Long-term after kidney transplantation.   "
64345|NCT02443428|"     The purpose of this prospective observational registry is to monitor safety of eribulin in     routine clinical practice. Additionally, this study will also assess the effectiveness of     eribulin in real-life settings.   "
64350|NCT02443363|"     The study included 300 patients who are post-kidney transplantation (> 3 months and <10     years). An analysis of body composition using bioelectrical impedance, calculated BMI and     serum creatinine was determined. Glomerular filtration rate (GFR) was calculated using the     formula CKD-EPI, Modification of Diet in Renal Disease (MDRD) and Cockroft-Gault.   "
64351|NCT02443350|"     Anti N-methyl-D-aspartate receptor encephalitis is an autoimmune encephalitis，found in recent     years，producing the specific IgG antibody induced by the NMDA receptors.It is the most common     curable disease among the non infectious-autoimmune encephalitis,usually has been     misdiagnosed as other causes of encephalitis.Our previous study found that there are     differences between the Chinese and the foreign in anti-NMDA receptor encephalitis such as     the sex ratio, the rate of combined tumor and clinical manifestations.As a new found     disease,the incidence rate has been underestimated.Therefore,to establish the Registry     Research Database for Chinese group of anti-NMDA receptor encephalitis is imminent.This study     will combine Beijing area's hospitals and foreign experts,depending on multicenter,     prospective and registry method,to understand the incidence in Beijing area,to summarize and     analyze the clinical data of patients.So,there will make a solid foundation for the     subsequent Beijing area detection platform and other research.   "
64352|NCT02443337|"     The main purpose of this study is to evaluate the safety and activity of the study drug known     as LY3023414 in combination with necitumumab in participants with metastatic squamous     non-small cell lung cancer (NSCLC).   "
64353|NCT02443324|"     The main purpose of this study is to evaluate the safety and preliminary efficacy of the     combination of the study drug known as ramucirumab plus pembrolizumab in participants with     locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ)     adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the     urothelium, or biliary tract cancer (BTC).   "
64354|NCT02443311|"     Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and     relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by     targeting pathophysiological pathways, and to provide long-term management by reducing     recurrences. Pimecrolimus is a novel topical selective inflammatory cytokine release     inhibitor; considering its mechanism of action it is reasonable to theorize that pimecrolimus     may effectively treat OLP without the potential side effects that are associated with     corticosteroids.   "
64357|NCT02443272|"     The purpose of this study is to compare abscess drainage utilizing the vessel loop technique     in children to the standard incision and drainage technique with the endpoint to determine if     rates of treatment failure are non-inferior.   "
64358|NCT02443259|"     Hypertensive disorders are the most common medical complications in pregnancy and major     causes of maternal, fetal, and neonatal morbidity and mortality. Fifty percent of     hypertensive disorders of pregnancy are defined as pre eclampsia, the most important     manifestation of the disease.      Preeclampsia is also a significant risk factor in the development of IUGR and represents the     most common cause of IUGR in the nonanomalous infant. The incidence of thrombocytopenia,     neutropenia and Bronchopulmonary dysplasia is also increased in neonates with preeclampsia.      The neurodevelopmental outcomes infants exposed to preeclampsia are highly variable. The     study by Gray et al showed that preeclampsia is associated with a decreased risk of cerebral     palsy. They also found a protective effect of maternal preeclampsia on cerebral palsy     regardless of exposure to magnesium sulfate. However, contrary to this, study conducted by     Shao-Wen Cheng et al has showed that infants born to pre-eclamptic mothers had lower MDI     scores at 24 months of age (P= 0.04) as compared to infants without maternal pre-eclampsia.     The study by Szymonowicz et al showed that neonates born to pre-eclamptic mothers had a     significantly lower mean mental developmental index, and significantly more of these children     had one or more impairments compared with the control group at 2 years of age. The     neurodevelopmental outcomes in neonates born to preeclamptic mothers therefore remain     inconclusive. Recently the role of neurobehaviour being evaluated early at 37-40 weeks of CGA     is being predicted as an useful adjunct to the 12-18 month full neurodevelopmental     assessment. This assumes significance in the context of initiation of early stimulation and     objectivised individual developmental rehabilitation regimens for these infants.   "
64359|NCT02443246|"     To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with     that of placebo in adults with Vitamin D Deficiency.   "
64360|NCT02443233|"     Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis.     There are still a lot of uncertainties on how infants acquired HBV leading to the development     of chronic HBV infection despite active and passive immunoprophylaxis. The investigators     would like to carry out a prospective study to answer the following questions:        1. the paternal, maternal and obstetric factors leading to immunoprophylaxis failure        2. the prevalence of immunoprophylaxis failure in Hong Kong   "
64387|NCT02442882|"     Prior research has investigated the effect of repetitive head trauma as it relates to     physiological and psychological function. Boxing is one particular sport which predisposes     athletes to a large amount of head impacts. We plan to assess the effects of a boxing     tournament on balance, neuropsychological, and visual functions.   "
64361|NCT02443220|"     A prospective, single-center, double-blinded, randomized, controlled clinical study to     evaluate the antalgic effects between regional or distant combination of acupoints stimulated     with electroacupuncture on patients undergoing Off-Pump Coronary-Artery Bypass     Grafting(OP-CABG).This clinical trial is to investigate whether electroacupuncture(EA)     anesthesia can reduce analgesic in OP-CABG surgery in distant group.The origins of     therapeutic acupuncture can be traced back at least 2,500 years in China. There has been an     explosion of interest in Western medicine within the United States and Europe in application     of acupuncture technique. Acupuncture enjoys worldwide acceptance for treating diseases such     as migraine, chronic low back pain, and knee osteoarthritis. In 2002, WHO recommended 107     symptoms, syndromes, and diseases definitively shown to be effectively treated by     acupuncture. Coronary heart disease (angina pectoris) is among these pathologies. A recent     clinical trial demonstrated an acupuncture-assisted anesthesia strategy reduces postoperative     morbidity and medical costs in open-heart surgery under cardiopulmonary bypass. Previous     researches in animal models have demonstrated that electroacupuncture pretreatment protects     the heart from ischemic injury. The investigators observed that electroacupuncture     pretreatment (EAP, 30-minute electric stimulation through 4 electrodes attached to the     bilateral forearm acupoints) before surgery significantly attenuated serum troponin levels     during and shortly post-surgery in adult heart valve replacement patients and children     undergoing cardiac surgery correcting congenital heart malformation.However, whether     electroacupuncture anesthesia may reduce analgesic in OP-CABG surgery,especially in different     combination of acupoints,has never been previously investigated.   "
64362|NCT02443207|"     The aim of the present study was to evaluate the perceived impact of dental caries and dental     pain on oral health-related quality of life (OHRQoL) among preschool children and their     families. A cross-sectional study was conduct with 843 preschool children in Campina Grande,     Brazil. Parents/caregivers answered a questionnaire on socio-demographic information, their     child's general/oral health and history of dental pain. The Brazilian version of the Early     Childhood Oral Health Impact Scale was administered to determine the perceived impact of     caries and dental pain on OHRQoL. Children have undergone an oral examination. Logistic     regression for complex sample was used to determine associations between the dependent and     independent variables (OR: odds ratio; α = 5%).   "
64363|NCT02443194|"     Primary tumor glioblastoma is the most common malignant brain. Standard treatment includes     biopsy or excision of the tumor in order to obtain a pathological diagnosis, and tumor mass     reduction. After the surgery patients are treated with radiation and Temodal. The most common     psychiatric symptom in this patient population is depression, valued at up to approximately     50% in patients with glioma . Depression not only adversely affects the quality of life of     patients but also impairs the ability and cognitive function due to the complex clinical     course of patients with glioblastoma. There is a tendency to give Diagnosis of depression in     this patient population, due to a lack of awareness, knowledge and literature on the subject.     This study was designed to prospectively randomized, controlled, double-blind study.      This method of recruitment - patients who undergo resection or biopsy of glioblastoma (newly     diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation     about the study and sign a consent form will enter research.   "
64364|NCT02443181|"     This study evaluates the effectiveness of tremor control using various strategies for     implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor.     Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated     using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or     thalamic electrodes.   "
64381|NCT02442960|"     This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment given     orally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one of     two cohorts in up to two clinical sites. Treatment will be given for 8 weeks and study     duration will be 12 weeks.   "
64365|NCT02443168|"     This is a single-center, 2-part, open-label study to evaluate the metabolism and excretion     and absolute bioavailability of [14C]-AG-221 in healthy male subjects. It is planned for 14     subjects to be enrolled; each subject will participate in a screening phase, a baseline     phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be     collected in Part 1 for analyses. Blood samples will be collected in Part 2. Subjects can     only participate in either Part 1 or Part 2.   "
64367|NCT02443142|"     Traumatic brain injury (TBI) is an important public health problem with an estimated 1.7     million new cases in the United States each year. Although the vast majority of these victims     sustain mild TBI, many still develop headache, difficulty concentrating, and decreased memory     with potential for serious long-term consequences. In particular, mild TBI is an important     consequence of combat-related injuries sustained by military personnel and sports-related     injuries in young adults. Unfortunately, treatment of mild TBI is usually limited to oral     analgesics for headache pain such as acetaminophen (Tylenol) or ibuprofen (Motrin or Advil).     Since there are no previous randomized trials of these medications for mild TBI, their     comparative effectiveness is not known. Increasing animal based evidence suggests that mild     TBI is related to brain cell injury caused by overexpression of a cellular enzyme (COX-2)     that causes neuroinflammation. Fortunately, inhibition of COX-2 is easily achieved using     ibuprofen. We hypothesize that head injured patients treated with ibuprofen will have a lower     incidence of mild TBI symptoms than patients treated with acetaminophen. We will conduct a     randomized clinical trial to measure the comparative effects of ibuprofen versus     acetaminophen on the incidence of specific symptoms of mild TBI in emergency department     patients with head injury.   "
64368|NCT02443129|"     The investigators would be interested in applying the enhanced depth imaging technique to     swept source optical coherence tomography, by modifying the acquisition protocol. Doing so,     the investigators hope to improve the visualization of the choroid and perhaps even of the     sclera.   "
64369|NCT02443116|"     The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in     patients with nonalcoholic steatohepatitis.   "
64370|NCT02443103|"     This study will explore the biologic activity of guanabenz in reducing bone turn over in     solid tumor patients with bone metastasis. If successful, this repurposing of an already,     generic drug could benefit patients faster than manufacturing a novel expensive compound.   "
64371|NCT02443090|"     To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and     sexual side effects.   "
64373|NCT02443064|"     1. Drug resistance of G+ cocci is a severe healthcare problem. According to the Ministry of          Health National Antimicrobial Resistant Investigation Net (mohnarin) surveillance          report, the isolation rate of MRSA is some 60% in China. MRSA infection has become a          serious clinical problem;        2. Vancomycin is a bactericidal glycopeptide antibiotic which inhibits bacterial growth by          hindering the synthesis of cell wall in bacteria. It exerts strong antibiotic effect to          Gram+ bacteria. It is indicated for serious staphylococcus infections especially MRSA          infection and has become the gold standard agent in MRSA treatment;        3. Vancomycin is a time-dependent antibiotic, its clinical and microbiological efficacy is          related to area under curve（ AUC）/minimum inhibitory concentration （MIC ）(AUIC). Cmin at          steady state is an surrogate parameter of AUIC, which is closely associated to the          efficacy;        4. AUIC >400 and Cmin between 15~20 mg/L are recommended for effective vancomycin treatment          by Infectious Diseases Society of America （IDSA） although it is still disputable;        5. Due to the absence of PK/PD study on vancomycin in China, administration of vancomycin          is performed in reference to the recommendation of IDSA. Its suitability to Chinese          patients is still to be clarified;        6. Plasma concentrations of vancomycin vary significantly between population and          individuals. Factors such as large-volume fluid infusion, hypoproteinemia and renal          clearance, etc. will influence the distribution and excretion of vancomycin, resulting          in different plasma concentrations between individuals. Results of PK studies differ          greatly between China and abroad. Administration based on the AUIC or Cmin recommended          by IDSA would not be suitable to Chinese patients. Given the definite long-term benefit          of vancomycin treatment, the AUIC or Cmin suitable to Chinese patients must be          identified by clinical study.        7. The PK/PD study on vancomycin in the treatment to MRSA septicemia and endocarditis is of          great significance for more reasonable use and improved therapeutic efficacy of MRSA          infection.   "
64374|NCT02443051|"     This research is designed to determine the effectiveness of attention bias modification for     socially anxious children and adolescents. Over the course of 3 years, 50 youth will be     enrolled in the trial.   "
64375|NCT02443038|"     This is a 2 year pilot/feasibility project to develop an intervention, test research methods,     and evaluate the effects of yoga on core strength and balance of an older rural population in     an effort to ultimately reduce the frequency of falls. The investigators' goal for this     project is for community and academic partners to develop a yoga program that is feasible,     safe, and acceptable to an older adult population, then test the program, research methods     and evaluation, in preparation for conducting a larger randomized trial of the intervention.   "
64376|NCT02443025|"     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on     tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either     receive a series of two presentations or wait listed to receive them later in the school     year.   "
64377|NCT02443012|"     Diabetic macular edema (DME) is a major cause of visual loss in patients with diabetes     mellitus. The standard treatment is with focal/grid laser therapy. Topical nepafenac was used     as an adjunct therapy for treatment of DME.      The aim of this study is to compare the difference of best corrected visual acuity (BCVA) and     central macular thickness (CMT) at 3 months post treatment between combination therapy of     laser and topical nepafenac and laser monotherapy in patients with DME.   "
64378|NCT02442999|"     Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for     fertility treatment to evaluate the impact of screening for obstructive sleep apnea.   "
64379|NCT02442986|"     Systemic inflammation and sepsis cause multi organ failure including severe neurologic     impairment in the course of disease. Neurologic failure typically presents as     critical-illness-polyneuropathy/-myopathy and septic encephalopathy during sepsis and is     associated with an increased mortality rate.      Clinical parameters to determine the neurologic entities during the course of sepsis are     heterogeneous. Further research for an association of clinical parameters and the patients'     outcome is needed.      The study aims toward differences in the clinical and neurological outcome of surgical and     non-surgical septic patients in comparison to non-septic patients on ICU. The aim of the     study is to identify clinical and diagnostic outcome predictors in septic patients.   "
64380|NCT02442973|"     Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are     only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This     device uses sound waves to create pictures of the spine in three dimensions. This may allow     the physician to view the spine in more detail for procedures such as spinal anesthesia and     other diagnostic procedures. Epidural analgesia is the mainstay procedure for the management     of labor pain. The precise placement of a needle or catheter in proximity to landmarks of the     spinal bone anatomy is required for the procedure to succeed. The current standard of care is     called the 'blind approach' (i.e. without medical imaging) and involves a physician manually     palpating a patient's back to locate spinal bone landmarks. The needle is then inserted with     respect to the location of the landmarks and inserted until a loss-of-resistance is manually     detected. This approach, while most common, has been associated with success rates as low as     68% in obese patients (2).      Alternative methods have been investigated for this problem, including ultrasound (US)     guidance, which offers real-time imaging. Several studies have demonstrated ultrasound's     efficacy for spinal anesthesia (1-6). However, standard US systems are engineered to image     soft tissue rather than bone structures, with the consequence that bone is imaged poorly. US     images are often degraded by a number of noise sources including speckle noise,     reverberations and off-axis scattering, particularly when bone is present, making     visualization of bone anatomy features difficult. Moreover, arranging access to ultrasound     for the purpose of spinal anesthesia alone is cumbersome. Thus, the efficacy of guided spinal     anesthesia and diagnostic procedures using standard ultrasound systems is limited and the     benefits that it offers are heavily dependent on the user's familiarity and skill with     ultrasonography (4).      Recently, new medical imaging technologies have been developed at Rivanna Medical, LLC to     address the significant clinical need for technological advances that improve the placement     of spinal anesthesia, epidural analgesia and other diagnostic procedures. The Accuro is a     pocket-sized and battery operated ultrasound instrument that incorporates new signal     processing-based technologies for enhanced bone imaging including 3D navigation of the lumbar     spine. The device is a single self-contained unit consisting of an ultrasound system,     ultrasound probe, and rotatable touchscreen display. The instrument enables a SpineView3D™     technology to facilitate spinal anesthesia guidance with real-time 3D navigation of the     lumbar spine anatomy.      SpineView3D™ technology facilitates image interpretation of individual 2D lumbar spine scans     by automating spinal bone landmark detection and depth measurements and providing a real-time     assessment of scan plane orientation in 3D. SpineView3D™ makes image interpretation and     measurements of the lumbar spine anatomy simple, quick, and easy. Real-time 2D scans from     either SpineView3D™ or general-purpose bone presets are formed using patent-pending     BoneEnhance+™ technology. The BoneEnhance+™ technology provides images of bone anatomy at     greater bone-to-tissue contrast compared with conventional ultrasound image reconstructions.   "
64610|NCT02439970|"     To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of     cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV     seronegative pretransplant and received a kidney from a CMV seropositive donor   "
64382|NCT02442947|"     Using protective or combat garments under heavy heat stress conditions, during rest or     exertion, may hinder the body`s ability to effectively exchange heat with the environment and     thereby can lead to heat injuries. The purpose of this research is to physiologically examine     the new textile solutions that are planned to be integrated in the protective garments,     combat garments and work uniforms in the army, by evaluating the physiological stress     obtained during exertion under hot climatic conditions.   "
64383|NCT02442934|"     Since critically ill patients are exposed to stressful conditions, the investigators     evaluated the effectiveness of a multicomponent program to reduce perceived discomforts in     the Intensive Care Unit (ICU) .   "
64384|NCT02442921|"     Forty patients with diabetic nephropathy will be treated with colchicine up to 2 mg, or     placebo, for 18 months. A follow up will be performed after 12 additional months. The primary     outcome will be a significant reduction or stabilization of proteinuria during the 18 month     treatment period.   "
64385|NCT02442908|"     SF-K002 is a pilot study in patients with moderate to severe COPD suffering from involuntary     weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective     is to study the safety and tolerability of Nutrifriend Cachexia.   "
64386|NCT02442895|"     Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of     347 cycles performed with three different protocols.   "
65383|NCT02429856|"     This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior     Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty     (TKA) as the primary outcome.   "
64388|NCT02442869|"     This pilot study will test the feasibility of utilizing an adaptive intervention strategy for     college students who are suicidal when first seeking treatment at a campus clinic. Right now,     the typical strategy may rely on a one size fits all approach, but in fact suicidal     students vary greatly on what and how much they need. This study would allow clinical     decision making (trying one approach, and if that doesn't work, another) to be empirically     developed and tested while maximizing resources in overburdened college counseling centers.     If the aims of this project are achieved, this study could significantly impact service     delivery to suicidal college students at college counseling centers.   "
64389|NCT02442856|"     The overall objective of this study is to evaluate the use of diffuse correlation     spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with     vascular risk factors. Optical cerebral blood flow measurements will be correlated with     changes in arterial blood pressure to assess how CBF is maintained in response to changes in     ABP, and will be compared to transcranial doppler reference measurements.   "
64390|NCT02442843|"     This study is designed to identify changes in the brain that underlie symptoms of     combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild     electrical stimulation to the side of the head (using a method called tDCS) in an attempt to     reduce the symptoms of PTSD.   "
64391|NCT02442830|"     The objectives of this study are to test whether there are statistically significant     differences between the standard of care workup workup of non-hematemesis gastrointestinal     bleeding by endoscopy [upper, lower and other tests], compared with deployment of a video     capsule as the first test followed by the most appropriate endoscopic procedure based on     video capsule findings, if needed. The investigators propose to examine differences in time     to diagnosis, reduction in numbers of procedures, and length of stay between a standard of     care workup protocol and our proposed protocol of early capsule endoscopy deployment.   "
64392|NCT02442817|"     The purpose of the present study is to gather pilot data on the effects of linagliptin on the     concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in     humans, and to demonstrate the feasibility of such a study in patients with psychosis in our     setting.   "
64393|NCT02442804|"     The purpose of this study is to determine whether pomegranate supplements improve cognitive     functioning following stroke.   "
64394|NCT02442791|"     Experimental studies and previous clinical trials suggest neuroprotective effects of GLP-1     analogs in various degenerative neurological diseases, and in hypoxic brain injuries in     experimental designs. This study is designed as a safety and feasibility study with patients     randomized 1:1 to receive GLP-1 analogs immediately after hospital admission after out of     hospital cardiac arrest.   "
64395|NCT02442778|"     Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of     probable Alzheimer's disease (AD) will be based on the 2011 Diagnostic Guidelines for     Alzheimer's Disease issued by the National Institute on Aging (NIA)-Alzheimer's Association     (AA) workgroups.   "
64396|NCT02442765|"     Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of     probable Alzheimer's disease (AD) will be based on the 2011 Diagnostic Guidelines for     Alzheimer's Disease issued by the National Institute on Aging (NIA)-Alzheimer's Association     (AA) workgroups.   "
64397|NCT02442752|"     The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD)     [after daily administration for 7 days] and safety [after daily administration for 8 weeks]     of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with     acid-related diseases.   "
64404|NCT02442661|"     This research study is performed to compare the accuracy of two methods of lymph node     evaluation: research method versus standard method. Standard method is what is usually     performed as standard of care where the radiologist evaluates the images overall and decides     whether each node seen should or should not be biopsied. In the research method, a second     radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a     small specific checklist of ultrasound appearance to determine whether each node should or     should not be biopsied. Results of both the standard and research method will be used to     decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node     evaluation by standard method and subsequent lymph node biopsy are part of the standard     clinical care. It is less likely but possible that the research method may identify     additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.   "
64405|NCT02442648|"     The primary purpose of this study is to provide a preliminary evaluation of the safety and     potential efficacy of carfilzomib in reducing HLA antibody levels in highly sensitized kidney     transplant candidates.   "
64398|NCT02442739|"     The primary purpose of this study is to see if it is safe to give patients with pancreatic or     head and neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time     they receive radiation and/or chemotherapy for their cancer treatment to prevent depression     and its effects. Researchers would also like to see if giving ketamine at the same time as     cancer treatment is practical and reasonably acceptable to the patient.      New onset depression is highly frequent in those with head and neck cancer, and depression     has many negative consequences for outcomes in those patients. Depression has been known to     have greater incidence in pancreatic cancer patients than in patients with other     malignancies.      Therefore, investigators would also like to see if giving patients ketamine during their     routine cancer treatment will prevent the onset of depression and its negative effects on     cancer treatment outcomes, and also help with anxiety, pain, and quality of life. The study     will also use a placebo to compare to the good and/or bad effects of ketamine. A placebo is     not an active drug and it will be look the same as ketamine, as a liquid to be taken by     mouth.      Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic     by itself for some diagnostic and surgical procedures or combined with other general     anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered     experimental in this study because it is not approved by the FDA for the prevention of     depression.   "
64399|NCT02442726|"     The aim of this study is to measure reaction times and thermal detection thresholds to CO2     laser stimulation of the skin, before and after a first degree thermal injury, in the primary     and secondary hyperalgesia area, in order to investigate whether different nerve-fiber     classes are activated in the post-injury phase. The study results are expected to uncover     existence of a peripheral inflammatory input contributing to secondary hyperalgesia.   "
64413|NCT02442544|"     The gut microbiome is increasingly recognized as a contributor to disease states. In type 1     diabetes, alterations in gut microbiota may be linked to changes in intestinal permeability,     inflammation and insulin resistance. Prebiotic fiber is a dietary supplement that alters gut     microbiota and could potentially improve insulin sensitivity in children with type 1     diabetes. This pilot study aims to determine the feasibility of a 12-week dietary     intervention with prebiotic fiber in children with type 1 diabetes. The investigators     hypothesize that consumption of prebiotic fiber will alter gut microbiota and intestinal     permeability, leading to improved glycemic control. Prebiotic fiber is a potentially novel,     inexpensive, low-risk treatment addition for type 1 diabetes that may improve glycemic     control by changes in gut microbiota, gut permeability and inflammation.   "
64414|NCT02442531|"     The goal of this Phase1 clinical research study is to find the highest safe dose of CriPec®     docetaxel that can be given in the treatment of patients with solid tumours.   "
64400|NCT02442713|"     Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings: (1)     impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye movement     (REM) sleep. The first two patterns are common in other psychiatric disorders, while the REM     pattern is very characteristic in depression, so the phase-advance theory was accepted by     most of psychiatrists. Many researchers have focused on the biological rhythm to investigate     the etiological and pathophysiology of depression, and they think depression can be cured if     its sleep abnormality is ameliorated.      It is well known that most of antidepressants treat depression through 5-hydroxytryptamine     (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep     microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can     ameliorate the sleep architecture abnormality in depression by producing rapid suppression of     REM sleep.      Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for     serotonin receptors. On the other hand, it is known that, although all of SSRIs mainly     increase the extracellular serotonin level by inhibiting serotonin transport in the     presynaptic neuron, each SSRI has its unique pharmacological characteristics. For example, it     was reported by accumulating researches that the serum melatonin level increased markedly     after ingestion of fluvoxamine. The mechanism behind this effect is unknown, but one     possibility is increased melatonin synthesis, caused by effects on serotonin, which is a     melatonin precursor. Another possibility is that fluvoxamine inhibits the metabolism of     melatonin in the liver.      Thus, the property of fluvoxamine to increase serum melatonin level, or even recover the     circadian rhythm of melatonin in depressed patients, might improve the clinical outcome by     improving the sleep quality and quantity. By now, the changes of sleep architecture in     fluvoxamine treatment were assessed by only three clinical trials, and their results were     contradictive. This discrepancy might be due to the small sample size and different study     design, such as clinical trial duration. Moreover, two of three researches applied home-based     PSG assessment, which might have distorted the results of sleep architecture to some extent.     Thus, the effects of fluvoxamine on sleep architecture need to be clarified by more clinical     trials with standard PSG assessment.   "
64401|NCT02442700|"     Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in     HIV-infected patients who are on antiretroviral therapy especially protease inhibitors     including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug     interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected     individuals. The study was conducted as a randomized, double-blind, crossover study comparing     the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with     dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either     placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given     the other treatment for an additional 12 weeks. Patients were observed for lipid profiles     including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high     density lipoprotein (HDL); and the side effects including clinical and laboratory (serum     aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase     (CPK)). The follow-up visits were every 4 weeks until the end of the study.   "
64402|NCT02442687|"     To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily     and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in     patients with biopsy-proven nonalcoholic steatohepatitis   "
64403|NCT02442674|"     The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases     and maintains serum sodium concentrations in children and adolescent subjects with euvolemic     or hypervolemic hyponatremia.   "
64406|NCT02442635|"     This proposal aims to expand non-pharmacologic options for the control of symptoms during     chemotherapy using yoga practices. It is particularly focused on sleep disturbance with a     secondary focus on fatigue.   "
64407|NCT02442622|"     To determine if the addition of Astym treatment to traditional therapy produces a more     positive outcome then traditional therapy alone for the treatment of de Quervain's     tenosynvitis. Two groups will be examined with one group receiving traditional therapy and     the other group receiving traditional therapy in addition to Astym treatment protocol.   "
71595|NCT02348632|"     This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110     in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or     ADX-N05 202.   "
64408|NCT02442609|"     Patients need information for perioperative period and internet may be an interesting     alternative.This study analysed by questionaire what does patient look on internet:     information of perioperative period and specifically for anesthesia. Questionaire (8     questions) are distributed to the patient before surgery and after they were prepared by     surgeon. Population : adult (> 18 y), no emergency procedure.The mean question is the use of     internet for anesthesia information.   "
64409|NCT02442596|"     The aim of the project is to perform a multinational, prospective, observational study on     IAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be given     to epidemiology and outcomes.   "
64410|NCT02442583|"     Interview colorectal cancer survivors and use this input to create a brochure intended to     guide reduction of sedentary behaviors in this population. Have colorectal cancer survivors     review and comment on a draft of the brochure. A third group of colorectal cancer survivors     will wear an Actigraph activity monitor for one week, then receive feedback on their activity     level with the brochure. After one month this group will be surveyed by telephone regarding     their use of the brochure, and their physical activity level.   "
64411|NCT02442570|"     The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple     sclerosis.   "
64412|NCT02442557|"     The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective     immune tolerance induction in humans.   "
64415|NCT02442518|"     The accuracy of sonographic prenatal detection of invasive placentation is unclear. The     objective of this prospective, multicenter, observational study is to assess the performance     of ultrasound for prenatal identification of invasive placentation in women with placenta     previa.      This study involves more than 25 hospitals in Italy.   "
64416|NCT02442505|"     This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt     algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an     implanted pacemaker who have previously documented paroxysmal (intermittent) atrial     fibrillation. This study will compare the Microlife device detected atrial fibrillation     episodes to the pacemaker detected atrial fibrillation episodes.   "
64417|NCT02442492|"     Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high     risk of perinatal morbidity and mortality. In association with reduced circulating placental     growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling     of the maternal uteroplacental arteries. There is no known treatment for placental IUGR.     Management involves intensive fetal surveillance with delivery with evidence of serious fetal     compromise. However, remote from term, delivery is associated with significant perinatal     mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of IUGR-affected     pregnancies and may represent a novel therapy.   "
64418|NCT02442479|"     Resistance training has shown the most promise among interventions aimed to combat aging     muscle atrophy as it enhances strength, power, and mobility function, but induces varying     degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial     5-year funding period of this award (2001-2006). In the subsequent 5-year funding period     (2007-2012), the investigators built on this prior work by using a dose-response approach in     older adults - ultimately to optimize the treatment of age-related muscle atrophy. The     investigators tested four, long-term resistance training prescriptions in older (60-75 yr)     women and men to determine which prescription maximizes mechanisms driving muscle regrowth.     One of the innovations in this project was the use of a 4-wk pre-training program to reach a     plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from     which both mechanisms of measurable muscle hypertrophy and functional consequences of     hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent     experimental period. A randomized design was used to test the overarching hypothesis that a     novel program of mixed strength and power training would optimize the anabolic environment to     promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with     three specific aims.   "
64419|NCT02442466|"     Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was     preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and     relevance of results observed in pre-clinical studies to the human disease.   "
64420|NCT02442453|"     Periodontitis is initiated by microbial biofilm but its progression is mediated by an     abnormal host response to biofilm microorganisms.      In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygen     species (ROS) play an important role. Imbalance between antioxidant defense system of body     and ROS lead to a deleterious situation called oxidative stress.      Superoxide dismutase (SOD) is the key enzyme of body's antioxidant defense system whereas     malondialdehyde (MDA) is product of lipid peroxidation due to ROS. Free radicals and ROS have     short half lives in vivo of 10-6 to 10-9 seconds. Hence measurement of ROS is done by     measuring the concentration of biomarkers of tissue destruction.      For treating periodontal disease, conventional mechanical therapy comprising of scaling and     root planing (SRP) along with timely maintenance has been a gold standard and any other     therapy considered for treating periodontitis should always be used as an adjunctive and     never in lieu of it.      Curcumin, a hydrophobic polyphenol, is a principal active constituent of turmeric. Mechanism     of action of curcumin is twofold-its role as a strong antioxidant and as a strong     antibacterial. Its analgesic, anti-inflammatory and antiseptic properties offer additional     benefits.Periodontitis is a chronic disease of oral cavity accompanied by increased oxidative     stress. Therefore the clinical application of a natural antioxidant in the form of curcuma     longa can be beneficial in reducing oxidative stress and as an adjuvant in treatment of     chronic periodontitis.   "
64421|NCT02442440|"     Anisodamine has been widely used in China for its pharmacological effect on improving     microcirculation during shock. It has been reported that anisodamine is effective in reducing     mortality rate in children with meningitis. however, its effectiveness in patients with     septic shock has not been systematically investigated. The aim of the study is to investigate     the effectiveness of anisodamine in the treatment of patients with septic shock.   "
64439|NCT02442206|"     This mechanistic study is a single-center, randomized, double-blind, placebo-controlled,     cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and     lung function parameters in hyperinflated COPD patients.   "
64422|NCT02442427|"     There is a growing body of literature suggesting that monoclonal antibody could be     efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically     insignificant adverse effects.      The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed     infants <3 months old with RSV bronchiolitis will result in fewer infants with readmissions     to infirmary/observation or hospital for relapse during 3 weeks of follow-up after     discharge.   "
64423|NCT02442414|"     The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single     agent when given orally to adult patients with advanced solid tumors that have progressed     despite standard therapy, or where there is no standard therapy.   "
64424|NCT02442401|"     The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma     formation after harvesting LD flap.   "
64425|NCT02442388|"     The purpose of this prospective, randomized, double-blind study was to compare the     prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical     lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One     files.   "
64426|NCT02442375|"     The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective     radiation dose and introduction of an intermediate dose-level in the treatment of head and     neck cancer will results in less radiation sequelae and improved quality of life after     treatment whilst the recurrence rate in electively irradiated lymph nodes should not be     compromised.      A summary of the study protocol can be found here: http://rdcu.be/qgMv   "
64427|NCT02442362|"     This study was designed to compare the efficacy and safety of     aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for     metastatic gastric cancer (GC) patients.   "
64428|NCT02442349|"     A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia     Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease     has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor     Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor     Receptor Gene   "
64430|NCT02442323|"     Despite evidence regarding the benefits of physical activity in various cancer patient     populations, the effects of a home-based walking program for pancreatic cancer patients have     been under-explored. The aims of the proposed pilot project are to: (1) Assess the     feasibility of implementing a 12-week, home-based walking program among pancreatic cancer     patients; and (2) Examine the effects of a 12-week, home-based walking program on quality of     life (QOL) and symptoms among pancreatic cancer patients.   "
64431|NCT02442310|"     The purpose of this study is to look at the pharmacokinetics of a new formulation of     deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.   "
64432|NCT02442297|"     This study is for patients that have a type of brain cancer called Glioblastoma (GBM). The     body has different ways of fighting infection and disease. No single way seems perfect for     fighting cancers. This research study combines two different ways of fighting cancer:     antibodies and T cells. Antibodies are types of proteins that protect the body from     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special     infection-fighting immune cells present in the blood that can kill other cells, including     cells infected with viruses and tumor cells. Both antibodies and T cells have been used to     treat patients with cancers. They have shown promise, but have not been strong enough to cure     most patients.      The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor     2). This antibody sticks to GBM cells because of a substance on the outside of these cells     called HER2. Up to 80% of GBMs are positive for HER2 . HER2 antibodies have been used to     treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed     so that instead of floating free in the blood it is now attached to T cells. When an antibody     is joined to a T cell in this way it is called a chimeric antigen receptor (CAR). These CAR-T     cells seem to be able to kill tumors like the one these patients have, but they don't last     very long and so their chances of fighting the cancer are limited. Therefore, developing ways     to prolong the life of these T cells should help them fight cancer.      These HER2-CAR T cells are an investigational product not approved by the Food and Drug     Administration.      The purpose of this study is to find the largest safe dose of HER2-CAR T cells, to learn what     the side effects are, and to see whether this experimental intervention might help patients     with GBM who volunteer to test this new agent.   "
64433|NCT02442284|"     The purpose of this study is to evaluate the safety and efficacy of     ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with     genotype 1 chronic hepatitis C virus infection.   "
64434|NCT02442271|"     The purpose of this study is to evaluate the proportion of subjects achieving sustained     virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic     HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs;     ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.   "
64435|NCT02442258|"     This is an open-label, single dose study designed to assess the pharmacokinetics and safety     of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal     function.   "
64436|NCT02442245|"     Part one of this study will consist of baseline (BL) testing, 28 days of daily     supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists     of five visits, of which, the first visit will consist of maximal strength testing. The     remaining visits will consist of performance testing and muscle evaluation.      Phase two of this study will consist of six weeks of supervised resistance training along     with supplementation of XSurge. Following the six weeks of training, subjects will complete a     second acute exercise protocol. Measures to be evaluated will consist of performance testing     and muscle evaluation.   "
64437|NCT02442232|"     The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to     propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3     and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms     on biomarkers related to nitric oxide after propofol anesthesia. In addition, the     investigators will evaluate the effects of propofol anesthesia on biomarkers related to     nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme     inhibitors.   "
64438|NCT02442219|"     Persons with coeliac disease treated with a gluten free diet will be asked to give blood for     a new diagnostic blood test. In this test investigators will use multimerized HLA bound to     different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along     with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these     cells will be present in persons with coeliac disease regardless of gluten-intake.     Investigators will compare their findings with two control groups; Persons on a gluten free     diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten     containing diet (healthy control group). In the initial and main study investigators will     look at HLA DQ2.5 individuals, which comprise >90% of all persons with coeliac disease.   "
64441|NCT02442180|"     Steroid is the treatment of choice in patients with severe alcoholic hepatitis. However,     null- or partial responder of steroid treatment is recommended to consider liver     transplantation. The yearly demand for liver transplants far exceeds the supply of available     organs and alcoholic liver disease has been a controversial indication for transplantation.     Granulocyte-Colony Stimulating Factor (G-CSF) has been reported to have effect of     proliferation of hepatic progenitors in alcoholic steatohepatitis. The aim of this study is     to investigate the efficacy of G-CSF in patients with severe alcoholic hepatitis with null or     partial response to steroid.   "
64442|NCT02442167|"     Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology     for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for     diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a     prospective study in 2 university hospitals to determine diagnostic performance of FISH for     the diagnosis of malignant biliary strictures in Thai patients.   "
64487|NCT02441569|"     This trial examines the effectiveness of training pediatric primary care providers (nurse     practitioners, doctors) to use of strategies that enhance family/youth empowerment and     engagement during office visits for children with mild to moderate problems with anxiety.     Children coming for routine care at one clinic are screened for anxiety symptoms and seen by     either a specially trained provider or one of the clinic's other regular staff members.   "
66243|NCT02418624|"     A phase I trial to determine the recommended phase two dose of the combination of carboplatin     and olaparib.   "
64443|NCT02442154|"     Severe head injury is associated with airway compromise and poor respiratory effort. In     Mulago Hospital intubation is the mainstay intervention and then patients are subjected to     the wait and see strategy of delayed or no tracheostomy, very few undergo early tracheostomy,     and some patients are left without an artificial airway.Using endotracheal tubes is     associated with complications which have been shown to increase intensive care unit (ICU) and     hospital stay, morbidity and mortality.      Tracheostomy has been reported to have advantages over translaryngeal intubation but the     optimal timing of tracheostomy in patients with severe head injury is controversial. Studies     done elsewhere have showed that patients with severe head injury who undergo early     tracheostomy have better survival outcomes but no studies have been done in our setting   "
64444|NCT02442141|"     The purpose of this research study is to examine the effects of routine anesthesia on infant     brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the     brain of infants during surgery. This study will help the investigators detect possible blood     flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or     near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be     used. Sensors will rest on the child's skin and record measurements before, during and after     the surgery.   "
64445|NCT02442128|"     Several methods have been proposed to improve intubating conditions and minimize sevoflurane     induction time during sevoflurane induction in children. These include clonidine     premedication, [5] addition of nitrous oxide, [6] opioids, [7,8] or propofol [9].      Four Studies evaluated sevoflurane alone for intubation (9-12).Aim of this study: is to     evaluate the effects of two different dose of propofol preceded by a fixed dose of fentanyl     during sevoflurane induction on quality of tracheal intubation in children undergoing     elective surgery.   "
64446|NCT02442115|"     The clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and     mental health disruptions that occur with the three core behavioral criteria used for     diagnosis (social behavior, communication, restricted interests/repetitive behavior).     Co-occurring medical conditions, such as gastrointestinal dysfunction (GID), often are     overlooked when designing research strategies to understand the mechanisms underlying the     expression of ASD. This study was initially a collaboration between Children's Hospital Los     Angeles (CHLA) and the Children's Hospital at Vanderbilt University. The current research     project proposes to recruit subject at CHLA and the Center for Autism and Developmental     Disorders (CAND), a Children's Hospital of Orange County and University of California Irvine     (UCI) Health collaborative program. In Aim 1, the investigators will characterize GID in     pediatric populations with ASD. Over a 12 month period, subjects will receive standard of     care for their GID, typically functional constipation. The study population will be     characterized with a standardized instrument for diagnosing functional GI disorders in     children, the Questionnaire on Pediatric Gastrointestinal Symptoms, and with the clinical     acumen of an experienced pediatric gastroenterologist. Nutritional information also will be     collected to determine whether there are patterns of GIDs that correlate with dietary and     nutritional status. The in-depth characterization and treatment of GIDs in children with ASD     will provide a unique way of determining if ASD symptom and GID symptom improvement are     related to each other. In Aim 2, the investigators will do in-depth assessment of each     subjects functional status for social communication, emotional regulation, cognitive     function, speech-language, sensory integration, and a biomarker of oxidative stress. The     latter will be measured in urine samples over the course of one year. There are no direct     interventions for autism symptoms in this study. Rather, subjects will receive standard of     care for the GID diagnosis and secondary effects on ASD symptoms will be evaluated. Our power     calculation shows that the investigators will be adequately powered with the proposed study     design and recruitment targets. As part of the study, the investigators have developed a     collaboration with investigators in the University of Southern California (USC) School of     Engineering, in which the investigators will work with them to develop computational tools to     assist in the characterization of videotaped Autism Diagnostic Observation Schedule (ADOS-2)     assessments.   "
64447|NCT02442102|"     An early intervention for swallowing disorders (i.e., dysphagia) during endotracheal     intubation may improve patient outcomes. The investigators propose treatment sessions     targeting sensorimotor integration, strength, and range of motion during oral endotracheal     intubation with mechanical ventilation to reduce or prevent dysphagia and aspiration (food or     liquids entering the airway), establish a solid foundation in understanding reasons for     swallowing impairment after extubation from mechanical ventilation and learn new methods to     reduce or prevent these problems.   "
64448|NCT02442089|"     Missed health care appointments present a serious challenge to patient care. Especially in     government funded health systems like that of Chile, missed appointments can lead to delayed     care, wasted resources, and escalating costs.      This private-public-research collaboration seeks to provide a rigorous, practical evaluation     of a new patient reminder system, evaluate how health beliefs impact patient attendance, and     capture the potential for scaling up this or other health technology systems. Using a     mixed-methods approach this study will provide contextualized, triangulated analysis of     pediatric patient attendance in Chile.   "
64460|NCT02441933|"     This is a randomized, open-label, multicenter, phase III study comparing anthracyclines     followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant     therapy in patients with triple-negative breast cancer.      Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who     need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant     chemotherapy for TNBC are eligible.   "
64449|NCT02442076|"     Skin tremor induced by artery pulses are usually sensed by doctor's fingers in Traditional     Chinese Medicine(TCM). On the other hand, vibration of acupuncture needle was also stated by     Huang Di Nei Jing (Yellow Emperor). However; the characteristics of skin tremor and its     correlation with vibrating acupuncture needles, how the skin tremor and vibration of needles     varies from area to area, are not yet clarified.In this study, the abovementioned issues will     be investigated experimentally through non-invasive method.      About 10 healthy volunteers, aged 20~65, will be recruited. The investigators will measure     the needle and the skin tremor by video optical microscopy. The variation of skin tremor and     needle vibration and their spectra will be analyzed digitally. The model correlating skin     tremor, needle vibration and basic physiological parameters will be constructed.The fact that     the skin tremor and the needle vibration come from the same origin is expected.      However; due to the leverage effects and different dynamical responses to the source     vibrations at different frequencies, needle vibration might exhibit some difference from skin     vibration in their power spectra. This study should be able to construct a clear model of the     possible vibration sources such as heartbeat and breathing, the area dependence of     vibrations, the correlation between the skin and the needle vibrations, and the correlation     with other physiological parameters.   "
64450|NCT02442063|"     This phase Ib combination study is being conducted to assess the safety and tolerability of     radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions     with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration     of the mode of interaction (i.e. additive or synergistic interaction) between the selected     chemotherapy and radium Ra 223 dichloride with regard to myelosuppression.   "
64488|NCT02441556|"     This trial will provide valuable insights into the safety and efficacy of endovascular     treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of     estimated occlusion time.   "
65384|NCT02429843|"     This is a single center, open-label, nonrandomized, phase 1b study of TRC105 in combination     with standard dose treatment in patients with stage IV non-squamous non-small cell lung     cancer.   "
64451|NCT02442050|"     The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would allow     for prolonged re-dosing intervals while providing equivalent myocardial protection. The use     of del Nido solution has been used extensively in congenital heart surgery for over 25 years.     The primary objective is to determine whether expanding this technique to adult cardiac     surgery will confer significant benefits in both surgical workflow and patient clinical     outcome. The investigators hypotheses with regard to the del Nido solution will demonstrate     (1) a non-inferior delivery to the current blood-based cardioplegia strategy in functional     recovery or clinical outcome, and (2) superior delivery to the current blood-based     cardioplegia strategy in cost analyses.   "
64452|NCT02442037|"     Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem     cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled     prospective study.   "
64453|NCT02442024|"     The investigators aimed at evaluating the metabolic effects of the inversion of the typical     Italian sequence of food ingestion at the main meals in type 2 diabetic patients.   "
64454|NCT02442011|"     This is a bio repository of blood specimens from subjects with different Hematological     disorders.   "
64455|NCT02441998|"     Colorectal cancer is the second leading cause of cancer related death in the United States.     Colonoscopy is the most commonly performed screening procedure and diminutive polyps (<5mm)     are the most commonly found polyps during colonoscopy. Although these polyps have a very low     risk of harboring malignancy, they are routinely removed to determine surveillance intervals.      Narrow Band Imaging is equipped on widely available colonoscopes and in expert hands can     allow accurate real-time optical histologic diagnosis of colorectal polyps. If this practice     can be applied widely, there is significant potential for cost savings.      This has led to a 'characterize, resect and discard' strategy where polyps determined to be     hyperplastic (benign with no neoplastic potential) can be left in place and those determined     to be adenomatous (have neoplastic potential) can be resected and discarded.      It is unclear if endoscopists without prior expertise or training in Narrow Band Imaging can     achieve adequate diagnostic accuracy to put 'characterize, resect and discard' into wide     practice.   "
64456|NCT02441985|"     Primary orthostatic tremor(POT) is a rare progressive functionally disabling tremor disorder.     The characteristic features of POT are symptoms of unsteadiness in legs reported by patients     when they are standing and improvement of symptoms upon walking and sitting. Due to the     limited success of other treatment options there is a clear merit in continuing efforts to     explore and investigate novel treatment modalities. Transcranial magnetic stimulation (TMS)     is a well-established physiological tool to understand brain function. When repetitious TMS     pulses are delivered to a specific target at predefined stimulation parameters, it is     referred to as rTMS therapy.The investigators propose a novel approach to investigate the     clinical and physiological effects of low frequency rTMS therapy in POT. The overarching     hypothesis of this study is that low frequency rTMS therapy delivered to the cerebellum will     modulate the cerebellar excitability and result in clinical improvements.In order to     determine the physiological effects related to rTMS, the tremor physiology will also be     recorded with surface electromyography (EMG). The investigator will also record the changes     in cerebellum excitability in response to rTMS using cerebello-cortical inhibition (CBI), a     well-established TMS parameter.   "
64457|NCT02441972|"     The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective     for cancer diagnosis and therapy response.   "
64458|NCT02441959|"     The purpose of this study is to compare the clinical and radiographic outcomes of full     endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar     herniated discs in which the patient's leg pain is greater than back pain.   "
64459|NCT02441946|"     The purpose of this study is to evaluate the biological effects of abemaciclib in combination     with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone     in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal     growth factor receptor 2 (HER2) negative breast cancer.   "
71596|NCT02348619|"     This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter     study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult     subjects with OSA.   "
64461|NCT02441920|"     Periodontitis is a highly prevalent chronic inflammatory disease that is characterized by     loss of the periodontal ligament and alveolar bone, and is a major cause of tooth loss.     Results from clinical and epidemiological studies have suggested that periodontitis and tooth     loss are more prevalent in individuals with rheumatoid arthritis (RA). There is evidence to     suggest that periodontitis could indeed be a causal factor in the initiation and maintenance     of the autoimmune inflammatory response that occurs in RA. If so, chronic periodontitis might     represent an important modifiable risk factor for RA. However, to date longitudinal studies     on the effect of periodontitis on disease progression in RA are lacking. The aim of the     present study is to assess the periodontal status of patients enrolled in an established     longitudinal cohort of RA patients. These data will then be analysed to evaluate whether or     not periodontal inflammation is related to parameters of rheumatoid arthritis.   "
64462|NCT02441907|"     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.     The retina is like the film of a camera and is located in the back of the eye. This condition     can develop in diabetics where swelling results from leaking of fluid from the blood vessels     of the eye, into the center of the retina, the macula. If left untreated, this can affect     central vision. The current standard treatment for diabetic macular edema includes     medications injected directly into the eye (intravitreal injections) and laser eye treatment.     The drugs that are injected directly into the eye are known as anti-Vascular Endothelial     Growth Factor (anti-VEGF) agents which help to reduce the leaking. However, response in     patients to these anti-VEGF drugs can vary and examination of predictive factors is required.     This particular study examines cellular factors called cytokines in patients receiving     aflibercept, a type of anti-VEGF drug, in the hopes of detecting changes in cytokines that     can predict treatment response amongst groups of patients.   "
64463|NCT02441894|"     Primary Objective:      To assess the tolerability of cabazitaxel 25 mg per body surface area (m^2) with primary     prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms     of the incidence rate of febrile neutropenia (FN) (defined: absolute neutrophil count [ANC]     <1000 per volume [mm^3] and a single temperature of >38.3 degree or a sustained temperature     of ≥38 degree Celsius for more than one hour) during Cycle 1.      Secondary Objective:      To assess overall rate of FN and grade ≥3 neutropenia and diarrhea; frequencies of dose delay     due to adverse events (AEs); dose reduction due to AEs; relative dose intensity; incidences     of FN-related hospitalization and use of intravenous (IV) anti-infectives; tolerability     according to National Cancer Institute Common Terminology Criteria for Adverse Events     (NCI-CTCAE) v4.0; prostate specific antigen (PSA) response (50% decrease); tumor response     according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 if available.   "
64464|NCT02441881|"     A double blind randomised controlled trial of radiofrequency thermal ablation treatments of     great saphenous varicose veins: Venefit (Closurefast), vs. Radiofrequency induced Thermal     Therapy vs. Endovenous Radiofrequency.      Assessments by visual pain scores, duplex ablation and quality of life questionaires   "
64465|NCT02441868|"     This study is a pilot test of an intervention to train family caregivers of home hospice     patients about recognizing and treating shortness of breath.   "
64466|NCT02441855|"     Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the     leading cause of death. Prognostic scores have been developed to estimate the risk of adverse     outcome. Several serum biomarkers have been also investigated in patients with CAP. A growing     number of echocardiographic markers have been evaluated as possible predictors of prognosis     in patients with pulmonary and infectious diseases such as sepsis, septic shock, human     immunodeficiency virus infection, pulmonary tuberculosis, and chronic obstructive pulmonary     disease. As echocardiography is a non-invasive, reliable, cost-effective, and reproducible     diagnostic tool to evaluate cardiac function and structures, the investigators aimed to     investigate left and right ventricular functions and aortic elastic properties in CAP     patients. Furthermore, the investigators also aimed to observe relationships between     echocardiographic findings and inflammatory and cardiac serum biomarkers in patients with     CAP.   "
64467|NCT02441842|"     Perioperative hypertension is commonly associated with surgical craniotomy. As the     sympathetic nervous system and the renin-angiotensin-aldosterone system play a key role in     the development of this hypertension, preoperative single dose therapy with a -adrenergic     receptor blocker or an angiotensin converting enzyme (ACE) inhibitor may be useful in     preventing this. To assess this as well as to study potential markers of these two systems,     the investigators will perform a randomized, double blind, placebo controlled study to     compare the single dose effect of preoperative administration of a -receptor blocking drug     (atenolol) and an ACE inhibitor (lisinopril) with a control group receiving a placebo tablet     (glucose) on perioperative hypertension in craniotomy patients.   "
64468|NCT02441829|"     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral     dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired     renal function. Participants in the healthy control group will be matched to participants     with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).   "
64469|NCT02441816|"     The purpose of this study is to assess a new treatment pattern for aflibercept. The aim is to     achieve and maintain the best benefit of visual function and avoid unnecessary hospital     visits.      The hypothesis to be tested is whether intravitreous aflibercept given in an 8 week cycle of     treatment in year 1 and a capped treat and extend treatment paradigm in year 2 can lead to     improved vision and reading speed in eyes with active wet AMD over 2 years while reducing     hospital visits.   "
64483|NCT02441621|"     The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV)     and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left     ventricular diastolic dysfunction is still unknown. The aim of the present study was to     challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing     aortic valve replacement.   "
64484|NCT02441608|"     The purpose of this study is to prove the product tested does not cause photoirritation or     photosensitization reactions when exposed to sun light.   "
64611|NCT02439957|"     • To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention     of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and     received antilymphocyte induction therapy   "
64470|NCT02441803|"     Objectives:      Primary Objectives:        1. To determine the safety and feasibility of allogeneic hematopoietic stem cell          transplantation (AHSCT) as initial salvage treatment for patients with primary induction          failure (PIF) acute myeloid leukemia (AML).        2. To determine efficacy of AHSCT following decitabine, clofarabine, idarubicin, and          cytarabine (DCIA) salvage chemotherapy evaluated by overall response rate (RR), defined          as complete response (CR) or CR without platelet recovery (CRp) or CR with insufficient          hematological recovery (CRi).      Secondary Objectives:        1. To determine the percentage of patients with PIF AML eligible for AHSCT after up to 2          courses of induction chemotherapy.        2. To determine the early treatment-related mortality (TRM) (within first 4 weeks of first          salvage chemotherapy regimen with DCIA and day 100 TRM after AHSCT.        3. To determine the efficacy DCIA regimen as salvage chemotherapy for patients with PIF AML          (% of patients who achieve </=5% bone marrow blasts prior to AHSCT.        4. To determine the TRM at 1 year, relapse rate (RR), overall survival (OS) and event-free          survival (EFS) for patients with PIF AML treated with DCIA followed by early AHSCT.   "
64471|NCT02441790|"     Fractures of the fifth metacarpal neck are the most common injury involving the upper     extremity. Patients are typically young adult males. Restoring function quickly and reliably     for return to work and/or activity is important; these patients are a significant labour     force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting     a fracture is a trade-off. Immobilization allows stabilization and fracture healing, but     also causes hand stiffness and weakness leading to impaired function. Little prospective     research exists; there is no agreement for ideal duration of splinting or therapy,     demonstrating clinical equipoise. A new concept in hand rehabilitation is early active range     of motion (EAROM). The objective of this trial is to establish if EAROM provides improved     early (6 week) hand function when compared to standard immobilization.   "
64472|NCT02441777|"     The aim of this pilot study is to assess the ability of a new polarization sensitive optical     coherence tomography system to obtain high-quality images of retinal birefringence.   "
64473|NCT02441764|"     This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.   "
64474|NCT02441751|"     QT interval changes is measured during all phases of the operation. The protocol is focusing     at intraoperative bleeding events and is also observing QT interval changes during anesthetic     and operative procedures.   "
70635|NCT02361203|"     The purpose of this study is to determine whether aerobic exercise can enhance the effects of     exposure therapy treatment for fear of heights.   "
64475|NCT02441738|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of     developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains     the most feared complication of AF with an increase in risk by 5-fold.      Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the     advanced electrical and structural remodeling the single procedural results of catheter     ablation for persistent and longstanding persistent AF are rather disappointing without a     proven superiority of any applied strategy compared to others. However, repeated catheter     ablation can achieve better results. The surgical (epicardial) approach seems to be more     effective, though still a significant amount of failures exist. Checking the epicardial     ablation lines and if necessary making additional endocardial lines (which is a hybrid     ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most     complete lesion set.      The study objective of this pilot trial is to compare the safety and efficacy of repeated     catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic     epicardial surgery combined with endocardial catheter ablation (performed one-stage) in     preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory     patients with persistent or longstanding persistent atrial fibrillation.   "
64476|NCT02441725|"     This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a     measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD).     Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and     questionnaires.   "
64477|NCT02441712|"     This is a Randomized Controlled Trial (RCT) regarding the conservative treatment of     patellofemoral pain (PFP) with an impairment based rehabilitation program. Those with PFP can     have a variety of impairments, such as knee and hip muscle weakness, poor movement patterns,     weak core activation and muscle tightness. Several recent RCT trials have looked at treating     single impairments, but to date no RCT have address individualized patient impairments during     a rehabilitation program. Abnormal muscle firing patterns have also been identified during     functional tasks; such as jogging, stair climbing, and performing a single leg squat.     Conflicting studies have produced changes to the quadriceps and hip muscle firing patterns     with those with PFP. The abnormal activation patterns has been suggested to be why     strengthening programs alone do not improve movement patterns during functional tasks for     those with PFP. Patterned electrical neuromuscular stimulation (PENS) is a novel form of     electrical stimulation that replicates proper firing patterns based off healthy     electromyography patterns. The purpose of the study is to investigate the benefits of PENS     with a impairment based rehabilitation program for the treatment of PFP. The rationale for     this investigation is to assess the benefits of PENS with therapeutic exercise at improving     altered firing patterns of the lower extremity muscles during functional tasks.   "
64478|NCT02441699|"     This is a matched-cohort study designed to assess the health impact of a rural demand-driven     water and sanitation intervention that provides piped treated water and household level     pour-flush latrines and bathing rooms, as implemented by Gram Vikas.   "
64479|NCT02441686|"     This research study is evaluating a combination of three drugs called lenalidomide,     subcutaneous (injection under the skin) bortezomib, and dexamethasone (RVD) as a possible     treatment for multiple myeloma.   "
64481|NCT02441660|"     A prospective case control study to determine the effectiveness and longevity of 8% capsaicin     patch in treating neuropathic pain in persons with spinal cord injury. The investigators will     study spinal cord injury patients at South Texas Veterans Health Care Systems Spinal Cord     Injury inpatient unit and outpatient clinics.   "
64482|NCT02441647|"     The purpose of this study is to check the safety under normal conditions of use through the     emergence of signs of irritability and sensitization of the genital mucosa.   "
64485|NCT02441595|"     The purpose of this study is to explore if an intervention using Mindfulness Based Childbirth     and Parenting education (MBCP) targeted to stressed pregnant women is effective in: 1)     reducing prenatal stress, 2) preventing perinatal maternal mental ill-health, 3) preparing     the mother for labor and 4) promoting positive infant-caregiver attachment.   "
64486|NCT02441582|"     This study aims to determine whether prehospital 12 lead ECG telemetry decreases the time to     reperfusion in patients presenting with STEMI. A randomised controlled trial will be     conducted in Gauteng and the Western Cape among 100 adult patients (>18 years) presenting     with ST-elevation myocardial infarction according to a specific inclusion and exclusion     criteria outlined in the full protocol. Consenting patients will be randomly assigned to have     their prehospital ECG sent to the receiving cardiac facility or not. The onset-to-reperfusion     and door-to-reperfusion times will be recorded and compared between the two groups by using     the Fisher's exact test and a simple unpaired Student's t-test. Data will also be subjected     to multivariate analysis of variance to test for statistical significance within a variety of     factors that may influence reperfusion times.   "
64490|NCT02441530|"     Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial.     Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients     were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400     mg ibuprofen twice a day,2 days before the date of menstruation and continued through the     first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D     group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group     Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of     vitamin D are more prominent   "
64491|NCT02441517|"     The purpose of the study is to understand if there is benefit in treatment with a medicine     called enzalutamide in the re-treatment setting. Patients must have been previously treated     with enzalutamide in the pre-chemotherapy setting for a minimum of 8 months and have disease     progressed, followed by docetaxel and/or cabazitaxel for at least 4 cycles.   "
64492|NCT02441504|"     Background: The aim of the present study was to evaluate the changes in the microvascular     density and reactivity in patients with type 1 diabetes (T1D) resulting from low intensity     chronic exercise training.      Methods: This study included 22 (34 ± 7 years) consecutive outpatients with T1D and disease     duration > six years. We used intravital video-microscopy to measure the basal skin capillary     density as well as capillary recruitment using post-occlusive reactive hyperemia (PORH) in     the dorsum of the fingers. Endothelium-dependent and -independent vasodilation of the skin     microcirculation was evaluated in the forearm with a laser Doppler perfusion monitoring     (LDPM) system in combination with acetylcholine and sodium nitroprusside iontophoresis, PORH     and local thermal hyperemia.   "
64493|NCT02441491|"     ROHHAD (rapid onset obesity, hypothalamic dysfunction, hypoventilation, and autonomic     dysregulation) syndrome is a rare pediatric disorder associated with a cancer called     neuroblastoma and presumed to be driven by an attack of the immune system on specific area in     the brain. Patients develop severe symptoms and often succumb to this disease. Based on the     researchers' experience the investigators conduct a clinical trial to study intensive     immunosuppression with high-dose cyclophosphamide in these patients. In addition to     describing the symptomatic improvement, the investigators' trial seeks to define objective     markers of disease activity.   "
64494|NCT02441478|"     Epilepsy is a frequent neurological disorder with about a third of patients having seizures     despite treatment. At least some of these seizures can be linked to a low compliance and     therapy adherence of patients. Compliance is defined as the extent to which a person's     behavior (in terms of taking medication, following diets, or executing life style changes)     coincides with medical or health advice. Therapy adherence of patients suffering from     epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive     drug therapy is critical for effective disease management and low therapy adherence is     associated to higher mortality in epilepsy. The reasons for low therapy adherence are still a     matter of research. Some known factors influencing compliance in epilepsy are related to its     chronic nature, but others seem to lie in a complex interaction between psychiatric     comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy     adherence rests a variable difficult to measure, especially in epileptic patients where     classical tools such as questionnaires and electronic monitoring devices have been shown to     be imprecise. It has been argued that the term 'compliance' should be replaced by     'co-operative behavior' and non-compliance can therefore be interpreted as troubled     co-operative behavior. This behavioral approach offers the potential of using tools and     methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific     field on the border of psychology, economics and neuroscience, has used economic game     paradigms in order to operationalize cooperative behavior and to identify several brain areas     by functional brain imaging that have been linked to social co-operative behavior. The     majority of these brain areas are located in the frontal cortex [ventromedial     frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating     in the frontal lobe are subsumed under the term frontal lobe epilepsy (FLE) and represent     20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to     epilepsy surgery.      The investigator's project plans to study compliance and cooperative behavior of patients     suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the     behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-,     and education-matched healthy controls, (2) correlation of game behavior to brain activation     measured by functional magnetic resonance imaging in both patients and healthy controls and     (3) studying the link between cooperative behavior to compliance captured by pill counts and     questionnaires.   "
64495|NCT02441465|"     This study is to characterize the pharmacokinetics (PK) of a single intravenous (IV) infusion     of ^14 C-labeled vemurafenib administered shortly after an oral dose of vemurafenib and     following multiple oral doses of vemurafenib twice daily (BID) at steady state as well as to     estimate the absolute bioavailability of multiple oral doses of vemurafenib BID at steady     state in participants with BRAF^V600 mutation-positive malignancies. The study has two     periods: Period A and Period B. During Period A, participants will receive vemurafenib BID     orally from Day 1 to Day 20 and during Period B, participants will receive single IV infusion     of ^14 C-labeled vemurafenib along with vemurafenib BID oral dose.   "
64496|NCT02441452|"     The aim of this study was to compare the functional capacity of exercise by six-minute walk     test and lung function by spirometry, before and after Nuss procedure in subjects who have     undergone the early rehabiliation program with those who were under conventional care.     Researchers want to find out if early rehabilitation is a strategy to enhance recovery after     Nuss procedure.   "
64497|NCT02441439|"     This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously -     200 mg versus 500 mg.   "
64514|NCT02441218|"     The primary objective of this study is to demonstrate the superiority of ivabradine over     placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart     failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left     ventricular ejection fraction and currently receiving recommended therapy for this disease.   "
64498|NCT02441426|"     Malnutrition is considered one of the most prevalent risk factors for morbidity and mortality     in children under five. An estimated 20% of children in the developing world are malnourished     [1] and poor nutrition is linked to more than half of all child deaths worldwide [2].     Malnutrition in early childhood may lead to cognitive and physical deficits and may cause     similar deficits in future generations as malnourished mothers give birth to low birth weight     children [3]. In addition, malnutrition increases susceptibility and incidence of infections     and is associated with diminished response to vaccines.      The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that     alter gut function and impair children's nutrition, growth and development to help develop     new intervention strategies that can break the vicious enteric infection-malnutrition cycle     and reduce its global burden.      The overall objective of the MAL-ED Project is to quantify the associations of specific     enteric pathogens, measures of physical and mental development, micronutrient malnutrition,     gut function biomarkers, the gut microbiome, and immune responses in very young children in     resource-limited settings across eight sites that vary by culture, economics, geography, and     climate.      The central hypothesis of the MAL-ED Project is that infection (and co-infection) with     specific enteropathogens leads to impaired growth and development and to diminished immune     response to orally administered vaccines by causing intestinal inflammation and/or by     altering intestinal barrier and absorptive function. Data analyses will test for associations     between enteropathogen infections and growth/development to help illuminate:        -  which micro-organisms or mixed infections are most frequently associated with growth          faltering and poor development; and        -  at what age specific infections cause the most disruption to growth and development and          impair immune response.   "
64499|NCT02441413|"     The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early     stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust     and automated segmentation algorithms will be developed for these parameters, focusing on     quantitative computed tomography (CT) image analyses to provide the physician a more     sensitive diagnostics tool. The evolution of BOS over time will be monitored using nmon-rigid     image registration methods.   "
64501|NCT02441387|"     Predictors of response to pharmacological treatment of major depressive disorder will be     investigated. One hundred and twenty patients will be included in a naturalistic clinical     trial. Psychopathology, personality traits, cognitive performance, brain structural changes     and genetic polymorphisms will be evaluated. Patients will be followed for 18 months with a     pharmacological treatment algorithm and will be evaluated monthly until 6th month and every 3     months, up to 18 months. Psychoeducation will be offered to patients who did not remit until     3 months of pharmacological tretment.   "
64502|NCT02441374|"     There are some treatments after Stroke. Among these, use forced therapy (FUT), which is based     on overcoming learned disuse by reintroduction of the paretic upper limb in the performance     of daily activities. There are different protocols FUT to the daily time constraint, the     number of days and even the type of constriction. Researchers have developed a protocol using     four weeks constriction, daily constriction 24 hours and with the free end of the weekends.     Because it is a restrictive therapy, which requires the use of one of the arms and on the     other hand, this mode of treatment is open to criticism, however, despite the efficacy of the     protocol, patients do not have good adhesion to the protocol for the constriction severe over     time. The objective of this work is to verify the safety of the developed protocol and     analyze the feasibility of reducing the daily time of constriction 12 hours, with a new     protocol movement constriction, easier to perform and more patient acceptance. Participate in     this study 82 individuals hemiparetic post Stroke, which will be recruited to Neurovascular     Diseases Clinic and will be registered at the Rehabilitation Center of Integrated State     Hospital. Participants will be randomly divided into three groups: the FUT24 (non-paretic     upper limb constriction 24 hours a day, five days a week for 4 weeks), the FUT 12     (non-paretic upper limb constriction for 12 hours a day, five days a week for 4 weeks) and CK     (Classic Kinesiotherapy, at least 2 times a week for 4 weeks). Will be held weekly and after     the end of the monthly monitoring reviews protocols. For the rating scales are use: National     Institute of Health Stroke Scale, the Ashworth Scale, the Wolf Motor Function Test, the Motor     Activity Log, Fugl-Meyer Assesment, dynamometry handgrip and surface electromyography (flexor     and extensor muscles wrist). The researchers hope that this protocol does not bring damage to     the upper limb in constriction and it is established a new protocol FUT easier to perform and     more acceptable to patients, allowing the use of this technique by health professionals.   "
64503|NCT02441361|"     Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese     subjects. This trial aims to test whether exercise training can add to the benefits of     bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to     investigate whether exercise training can counteract bone loss induced by bariatric surgery.   "
64504|NCT02441348|"     Voice therapy is the standard-of-care for many of the nearly 140 million people in the United     States who suffer from voice disorders,1 yet patients claim that current therapies are     ineffective at meeting their voice needs.2 Published data by our research team indicate that     patients think that transfer of target voice techniques to every day voice use (i.e.     conversation) is the most difficult aspect of therapy,2 and that training techniques in     conversation is the most useful aspect of voice therapy.2 Unfortunately, traditional voice     therapy programs spend little, if any, time training voice techniques in conversation.3 This     lack of functional specificity in voice therapy may contribute to the estimated 65% attrition     rate.4 Even after some form of treatment, patients are still struggling with daily     conversational voice use, and voice disorders continue to cause serious disability, stress     and depression, which negatively affects social functioning and job performance.5 A new voice     therapy program, Conversation Training Therapy (CTT), based on published patient reports on     dissatisfaction with traditional therapy, was developed by the Investigators. It was honed     with recommendations from expert clinical voice-specialized speech-language pathologists, and     successfully piloted in a small case series of patients with voice problems. The     investigators objective in this application is to test CTT in the rehabilitation of patients     with voice disorders. The investigators hypothesize that, as demonstrated in the     investigators preliminary case studies, these methods will result in early treatment success,     and reduce the time required to reach therapeutic goals, thereby reducing costs associated     with voice treatment.   "
64505|NCT02441335|"     The goal of this study is to examine how cellular dysfunction can lead to preterm birth.     Women with singleton pregnancies with spontaneous preterm labor, preterm premature rupture of     membranes, and cervical insufficiency (20 to 36-6/7 weeks gestation), and term deliveries     (greater than 38 weeks) will be enrolled. Medical/obstetric history and pregnancy outcomes     will be recorded. Maternal blood, urine and cervical cells (enrollment); cord blood and     placental biopsy (delivery) will be collected.   "
64506|NCT02441322|"     This study is to assess the utility of high resolution 3D echo planar magnetic resonance     spectroscopy (3D EPSI) in monitoring Novo-TTF response in glioblastoma multiforme (GBM)     patients.   "
64507|NCT02441309|"     This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target     sample size of 40 patients will be recruited from up to 8 EU countries, but this may be     revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma     will be divided into three treatment groups. They will all either have surgery or a biopsy     before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or     Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum     of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36     weeks of Mifamurtide treatment.   "
64508|NCT02441296|"     The optimal choice of carbohydrate in infant formula needs to be assessed in more detail.     Lactose has conventionally been used in most milk-based infant formulas, but more recently     lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity.     However, the metabolic consequences have not been examined.      In a pilot study, the investigators will assess the postprandial metabolic response to a meal     of formula with either lactose or maltodextrins. A breastfed reference group is also     included.   "
64509|NCT02441283|"     This is a rollover study to assess resistance and durability of response to ABT-493 and/or     ABT-530 in subjects who have participated in Phase 2 or 3 clinical studies with these agents     for the treatment of chronic HCV.   "
64523|NCT02441101|"     This clinical study has been designed to test whether a new pacing therapy would lead to     improvement in heart function, symptoms and quality of life in a specific group of heart     failure patients. This group has a unique electrical conduction problem (Right Bundle Branch     Block) that did not respond well to the current available pacing therapy.   "
64524|NCT02441088|"     Participants in this research study have tumors that express somatostatin receptors such as     neuroendocrine tumors, medulloblastoma, meningioma, and neuroblastoma.      Approximately 64 people will participate in this study conducted at the University of Iowa.   "
65385|NCT02429830|"     The purpose of this study is to evaluate the LINX device in patients who have previously     undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal     reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.   "
64510|NCT02441270|"     In metastasized of locally advanced breast cancer patients, local problems often occur like     skin metastases, ulcerations or lymph node metastases. These problems are related to a worse     quality of life, while overall survival is generally in the order of months to years.     Treatment of these lesions is challenging, especially after failure of first or second line     systemic therapy. Local treatments, like radiation, are able to give short-term palliation,     but the effect is often disappointing in the long run. Therefore, the search for new     therapeutic strategies like the combination of local and systemic treatments is emerging.      Recent investigations clearly show that radiation is capable of inducing a systemic     anti-tumor response. Both in mouse models and in patients, it was reported that irradiating     one metastasis can slow down the growth of other non-irradiated metastases. This effect is     called the abscopal effect and is immune-mediated. There are also several chemotherapeutics     that are capable of influencing the immune response like cyclophosphamide. Cyclophosphamide     is a known inducer of immunogenic cell death, which leads to the activation of dendritic     cells and thus the presentation of antigens.      In this pilot study the investigators wish to identify the immunological effects of combined     treatment with radiation and cyclophosphamide in breast cancer patients. Five patients with     metastasized breast carcinoma will be treated with the combined treatment and the     immunological effects will be monitored using repeat blood draws and biopsies. These effects     will be correlated to the clinical response.   "
64511|NCT02441257|"     Laryngeal mask airway is seldom used for control ventilation in America, while it is popular     in China. The question is whether the incidence of gastroesophageal reflux in control     ventilation is really higher than in spontaneous ventilation. So the investigators combine     the third generation laryngeal mask and catheter-based Digitrapper ph-Z monitor system to     evaluate the exact incidence of gastroesophageal reflux in these two groups.   "
64512|NCT02441244|"     Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience of     HIV infection. However, increased rates of adverse health conditions that are related to     immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in     ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T     cell loss and the leaking or translocation of luminal gut bacteria and other microbes     across the bowel wall and into the bloodstream.      The use of complementary and alternative therapies is common among people living with HIV,     however their efficacy has generally not been well demonstrated. Probiotics are live microbes     that may provide a health benefit to the host and the investigators believe that the     simultaneous use of probiotics along with antiretroviral therapy (ART) will improve gut CD4 T     cell restoration and function and therefore reduce microbial translocation and immune     activation.      Probiotic Visbiome consists of a high potency blend of eight different probiotics. The     precise mechanism of action of Visbiome is unknown, but preclinical studies have shown that     Visbiome may modulate the immune response towards a phenotype that is associated with reduce     inflammation, and Visbiome was also protective in a non-human primate model of SIV infection.     Therefore, we believe that the beneficial bacteria from Visbiome will accelerate the     normalization of gut immune cells and function in HIV-infected individuals as they start ART.     Early resolution of gut immune cells may normalize microbial translocation and immune     activation and will reduce the rates of HIV-associated comorbidities.   "
64513|NCT02441231|"     Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience of     HIV infection. However, increased rates of adverse health conditions that are related to     immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in     ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T     cell loss and the leaking or translocation of luminal gut bacteria and other microbes     across the bowel wall and into the bloodstream.      The use of complementary and alternative therapies is very common among people living with     HIV, with estimates ranging from 16-60%. However, their efficacy has generally not been well     demonstrated. Probiotics are live microbes that may provide a health benefit to the host and     the investigators believe that the simultaneous use of probiotics along with ART will improve     gut CD4 T cell restoration and function and therefore reduce microbial translocation and     immune activation.      A major challenge to HIV treatment is the suboptimal CD4 T cell count despite successful HIV     suppression on ART in immunologic non-responders (INRs). These individuals are at increased     risk of AIDS-related deaths and non-AIDS related comorbidities that may be associated with     increased immune activation and microbial translocation from the gut mucosa. With limited     treatment options, alternative therapies to reduce inflammation and restore gut immunology     will be important. Probiotic Visbiome consists of a high potency blend of eight different     probiotics. The precise mechanism of action of Visbiome is unknown,but preclinical studies     have shown that Visbiome may modulate the immune response towards an immunoregualtory     phenotype with increased the levels of IL-10 and reduced levels of proinflammatory cytokines     (TNFα, IL1β and IL-8). Therefore,the investigators believe that the beneficial bacteria     from Visbiome will accelerate the normalization of gut immune cells and function in     HIV-infected INRs. It is hypothesized consumption of Visbiome for 48 weeks will help restore     the immune system in INRs who have suboptimal immune reconstitution to currently available     ART. Resolution of gut immune cells will mean that microbial translocation and immune     activation will be normalized and will reduce the rates of HIV-associated comorbidities.   "
64520|NCT02441140|"     This research study is studying a possible test which may help doctors diagnose women with     ovarian cancer.   "
64525|NCT02441075|"     This is for a study for patients that will be undergoing hematopoietic stem cell transplant     (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the     most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or     Cyclosporine along with methotrexate are used together in order to prevent GVHD. Normally     these medications are given via the white lumen and blood is drawn via the unexposed red     lumen to check the blood level of these medications. If these drugs are accidentally given     via the wrong lumen (line) it could cause blood levels to be falsely high. This error could     lead to the patient having to have peripheral blood draws that cause pain. The investigators     are proposing adding an ethanol lock to your lumens (lines) to see if this would help clean     the lines therefore preventing errors in blood tests and blood draws. An ethanol lock is a     70% alcohol which is injected into the CVL lumen and stays within the CVL as the CVL is     capped.   "
64526|NCT02441062|"     Participants in this study have been diagnosed with a tumor such as a carcinoid,     neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which     carry somatostatin receptors.      The purpose of this research study is to see if the tumor can be identified using a special     procedure called a positron emission tomography (PET) scan and how the results of this     imaging procedure will change the management of the tumor.   "
98765|NCT01993407|"     The purpose of this research study is to investigate different types of task training to     determine if training improves thinking processes following traumatic brain injury.   "
64515|NCT02441205|"     PURPOSE: The purpose of this study is to investigate whether High Intensity Interval Training     (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In particular,     there is specific interest in describing the effects of an interval exercise program on     inflammatory state and immune function.      DESIGN: Subjects will be sedentary, 65 to 80 years old adults, with prediabetes as defined by     fasting plasma glucose (100 to 125 mg/dl). Before and after a 10-12 week High Intensity     Interval Exercise training program subjects will undergo several tests including: 1) a     maximal treadmill test, 2) an Oral Glucose Tolerance Test, 3) muscle biopsy, 4) body     composition, 5) several physical function tests and 6) other health related measures     including lung function, arterial stiffness and several blood measures (e.g. liver enzymes,     kidney function).      DATA ANALYSES & SAFETY ISSUES: As there are no comparison groups, data analyses will consist     of performing paired t-tests on pre and post exercise training values for each of the     measurement variables of interest. In addition, the data will be used to provide power     calculations for future grant proposals. High Intensity Interval Training is a very safe     exercise modality. The regular use of vigorous intensity exercise intervals have been used     extensively in exercise training. In fact, the exercise intervals will start at levels lower     and will be of shorter duration than were used during the maximal exercise test. They will     then be carefully and slowly made to be more challenging as each subject is able to safely     tolerate.      HYPOTHESIS: The investigators hypothesize that HIIT will result in significant improvements     in markers of inflammation, immune system markers and other health-related risk factors.   "
64516|NCT02441192|"     Background. The cardiovascular and cardiorespiratory coupling (CVCRC), focusing to recognize     the synergies of standard or modified physiology that promote healthy. The investigators aim     to study the effects of different training modalities and detraining on CVCRC.      Methods. 32 young males were distributed in four randomized training groups: aerobic (AT),     resistance (RT), aerobic plus resistance (AT+RT) and control (C). They were tested before,     after the training (6 weeks) and after the detraining (3 weeks) through a graded maximal     test. A principal component (PC) analysis of the time series of selected cardiovascular and     cardiorespiratory variables was performed to evaluate the CVCRC. The PC1 coefficient of     congruence in the 3 experimental conditions (before, after training and after detraining) was     calculated for each group.   "
64517|NCT02441179|"     Spinal cord injury (SCI) interrupts descending synaptic pathways from brainstem premotor     neurons to spinal motor neurons, thereby paralyzing muscles below the neurological level. In     recent years, considerable evidence has demonstrated that acute intermittent hypoxia (AIH)     elicits plasticity in the spinal cord and strengthens spare synaptic pathways which is     expressed as respiratory and somatic functional recovery in animals and humans suffering from     incomplete SCI. The fundamental hypothesis guiding this project is that AIH-induced motor     plasticity can be harnessed to improve walking capacity in incomplete SCI patients,     classified as C and D categories according to International Standards for Neurological     Classification of Spinal Cord Injury (ISNCSCI). The inclusion criteria include patients > 18     years-old, with traumatic or non-traumatic, non-progressive incomplete SCI, onset > 6 months,     neurological level C5-T12, with walking ability with or without assistive devices, without     joint contractures, orthopedic injuries, osteoporosis, cutaneous lesions, cardiopulmonary     complications and a body weight below 150 Kg. A randomized, triple-blind, placebo-controlled     parallel design study will be done including 100% of patients fulfilling the criteria.     Participants will receive repetitive acute intermittent hypoxia (rAIH: 15 episodes of 90     second 9% inspired oxygen interspersed with 90-second normoxia) or repetitive continued     normoxia (rSham: 21% inspired oxygen) combined with 45 minutes body weight-supported     treadmill training on 5 consecutive days and then three times per week for 3 weeks. Primary     outcome measurement will be the 10-meter walking test. Secondary outcome measurements include     the 6-minute walking test, timed up and go test, body/weight load, modified ashworth scale     and visual analog scale. All outcomes will be measured before beginning the protocol     (baseline), after five days of AIH/Sham (D5), weekly up to the end of the study (W2-W4), and     a post-study follow-up for 2 weeks (F1-F2). Aditionally, cognitive assesment before and after     the study will be performed using the Figura compleja de Rey-Osterrieth and the Test de     aprendizaje verbal España Complutense (TAVEC). Repetitive AIH and body weight-supported     treadmill training may represent a novel, safe, and noninvasive potential therapy to     partially restore walking function in incomplete sub-acute and chronic SCI patients, a     population with limited, if any, potential for improved function.   "
64518|NCT02441166|"     The hypothesis of the study is that Bone Marrow Tryptase (MT) level is a diagnostic marker of     Systemic Mastocytosis (SM). Determination of the bone marrow tryptase in Bone Marrow Aspirate     (BMA) could be a new diagnostic criteria for systemic mastocytosis with sensitivity close to     100% and a low false negative rate. This new test could be useful to improve the ability to     diagnose accurately systemic mastocytosis (in particular the indolent forms). Because of its     limited invasiveness compared to bone marrow biopsy, it could also be considered as a test     performed before bone marrow biopsy. Only patients with high bone marrow tryptase would then     undergo bone marrow biopsy.      In the future and if validated by this study, bone marrow tryptase could be a useful marker     of mast cell load and help to monitor the efficacy of treatment in systemic mastocytosis.   "
64519|NCT02441153|"     This pilot study will take place at Health Sciences North (HSN) in Sudbury. Patients will be     identified and screened for inclusion into the study once referred to a general or colorectal     surgeon for resection of their rectal cancer. This may occur before or after preoperative     chemoradiotherapy (CRT) but randomization will take place after CRT.   "
64521|NCT02441127|"     Aims: The aim of present randomized controlled clinical study was to evaluate whether the     additional use of diode laser would facilitate the donor surgery, improve the palatal wound     healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with     connective tissue (CTG) grafts.      Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the     de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode laser     (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and     photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using     Oral health related Quality of life (QoL), smile related QoL and visual analogue     scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.   "
64522|NCT02441114|"     This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone,     salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and     HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients     with chronic obstructive pulmonary disease (COPD).   "
64577|NCT02440399|"     Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for     the mother to nurture the newborn child and establishing an appropriate mother-child bonding.   "
64527|NCT02441049|"     Entre Familia was a 4-year randomized controlled trial funded by the American Cancer Society.     The study was conducted in Imperial County, California, and involved a partnership between     the Institute for Behavioral and Community Health at San Diego State University and Clínicas     de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive primary     care services to residents throughout Imperial and Riverside Counties. The investigators     enrolled 361 Latina mothers and one of their children aged between 7 and 13 years old; in 25%     of families, the father was also enrolled. Participants were randomly assigned to either an     intervention or delayed-treatment control condition. The intervention consisted of a     community health worker (or promotora)-delivered home-based intervention to promote healthy     eating. The promotoras used a telenovela DVD series and accompanying manual, both written and     produced by study staff. The intervention was delivered through 11 home visits and 4 support     telephone calls over a 4 month period. Participants in the delayed-treatment condition     received intervention materials when evaluation assessments had been completed. Evaluation     measures were taken at baseline, 4 months (immediate post-intervention) and 10 months     (6-months post intervention). Participants completed a self-report interview with study staff     at each time point. Height and weight measurements were also collected for the mothers and     children. The primary outcomes were changes in mothers' daily fruit and vegetable intake.     Secondary outcomes for mothers, children and fathers included changes in fat intake, sugary     beverage intake, parenting strategies, and perceived barriers to healthy eating.   "
64528|NCT02441036|"     Up to 15 subjects will be enrolled and randomized. Randomized subjects will receive one     single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's     scheduled facelift procedure, resected tissue will be obtained for analysis.   "
64529|NCT02441023|"     The purpose of this study is to evaluate the effectiveness of nutrition therapy in     combination with education in diabetes using a multimedia application for improving     indicators of metabolic control in patients with type 2 diabetes.   "
64530|NCT02441010|"     The purpose of this study is to use monitoring and intervention technologies in suboptimal     health status in a general population in China and evaluate the effectiveness of these     technologies in the improvement of suboptimal health status.   "
64531|NCT02440997|"     The purpose of this study is to preliminarily establish the extent to which a brief     aromatherapy intervention incrementally improves subjective and objective indicators of     discomfort (pain, anxiety, and heart rate variability) beyond passive relaxation in youth     with chronic headaches. A secondary objective is to establish the safety of using     aromatherapy as a treatment strategy in youth with chronic headache. The investigators     hypothesize that children randomized to the aromatherapy condition will demonstrate a greater     improvement in pain, anxiety, and objectively measured distress (heart rate variability) than     comparable children receiving only a passive relaxation treatment (a foot bath). The     investigators further hypothesize that the aromatherapy intervention will be safe and     well-tolerated by study participants.   "
64532|NCT02440984|"     The purpose of this study is to assess and explain (at least apart) anorectal disorders of     patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system     and epithelial barrier dysfunctions. The investigators' aim hypothetics is that autonomic     neuropathy of patients with Spina Bifida induce enteric nervous sytem and epithelial barrier     dysfunctions which explain anorectal disorders of these patients. Thexpect to show a     decreased of 5% of enteric neurons per ganglia.   "
64533|NCT02440971|"     Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep     disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and     have important prognostic implications. SDB is however, treatable with the use of non     invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The     aim of the study is to observe and investigate the potential role of ASV in the management of     heart failure.      Patients that agree to participate in this study will be requested to use an ASV ventilator     device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is     approximately the size of a large shoe box, which can be placed at the side of the bed, with     tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows     positive air pressure as determined by the device itself as it constantly monitors the     patients breathing throughout the night. During this study, the patients breathing patterns     will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a     SleepMinder will sit on the patients bedside locker as another form of monitoring of their     sleep patterns. Study staff will monitor the patient and give them frequent support, and they     will also be asked questions regarding their experiences with this equipment and any symptoms     they may have over this time. They will be followed up regarding this study at the same time     as their follow-up requirements for their heart failure. This study will be conducted in     total over 3 months.   "
64677|NCT02439086|"     The purpose of this study is to determine whether 18F-FDG-PET-CT and texture analysis of MRI     performed 9 weeks after Neoadjuvant Chemo-radiotherapy in patients with locally advanced     rectal cancer has the ability to identify patients with Complete Response.   "
64534|NCT02440958|"     Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery     remains the only treatment offering an advantage in terms of overall survival (5-year     survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease     at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for     advanced pancreatic patients, no drug or combination of drugs has significantly improved the     prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival     advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies,     modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved     safety profile in digestive malignancies. The purpose of this phase II multicenter study was     to investigate the efficacy and safety in patients with pancreatic cancer who progressed in     gemcitabine-based first line chemotherapy.   "
64578|NCT02440386|"     The iLink Study examines whether a Conditional Economic Incentive (CEI) may be an effective     tool for improving linkage to HIV treatment and care following referral for antiretroviral     therapy (ART) services from a mobile health clinic in Cape Town, South Africa. The study     examines the feasibility and acceptability of using a R300 (approximately $25 as of April     2015) voucher - that is exchanged for cash upon initiation of ART within 3 months - to     increase the uptake of ART among men and women living in low-income areas. This pilot study     (n=64) includes a randomised control trial, follow-up telephone calls and medical record     reviews, and in-depth interviews.   "
64535|NCT02440945|"     It is about an interventional study.The use of the blotting paper called Dried Blood Spot     or DBS is a method of systematic neonatal screening of the metabolic diseases. Indeed, it has     multiple interests: realized thanks to lancets, it is much less invasive than a classic blood     collection. Besides, the transport of the blood sampling is facilitated because most of the     analysts are stable on DBS at room temperature one week or more. Finally the use of this DM     reduces the infectious risks bound to the manipulation of the blood sampling and to the     inactivation of microorganisms. The moderate results are vitamin D, albumin, prealbumin, CRP,     orosomucoide      The DBS presents a major interest for the care of the old and fragile people who have on one     hand a low peripheral venous capital and on the other hand for whom the possibility of a     dosage on DBS will allow a facilitated biological follow-up. Indeed it is very important to     detect as soon as possible the most fragile old people, those who have the biggest risk of     seeing their health degrading during a physical, psychic or social stress, to concentrate the     efforts of coverage and limit these risks. The advantage of the biological criteria is the     speed of the test making (a blood test), in the absence of necessity of active participation     by the patient (the clinical criteria require to test the patient in the walking, to test its     muscular strength, etc.) and in the saving of time diagnosis for the clinician. The blood     biological markers of the fragility are essentially the rate of 25OH vitamin D, the markers     of undernutrition (albumin, prealbumin) and of the inflammation (CRP, orosomucoïde). These     last four parameters are now measurable from the DBS thanks to the quantitative mass     spectrometry.   "
64536|NCT02440932|"     Low-phenylalanine diets are commonly prescribed to people with phenylketonuria (PKU), an     inborn disease which causes accumulation of amino acid phenylalanine (Phe) in the blood. High     blood Phe levels can cause mental, behavioural, neurological, and physical problems. Thus,     low-phenylalanine diets help patients to manage their condition but it is not clear whether     they have an impact on appetite, energy intake and changes in body weight. This is important     to explore as prevalence of obesity in this population is rising high. This study aims to     find out the effect of PKU-type meals on appetite, appetite biomarkers, and post-meal energy     expenditure. The investigators will recruit 26 healthy adults and ask them to participate in     two experimental trials. On one occasion the participants will be asked to consume a     PKU-supplemented drink followed by a PKU type-lunch and on another occasion the supplement     and lunch will be based on normally consumed foods. Series of blood samples will be taken and     appetite will be assessed during both experiments. Both experimental trials will finish with     consuming an all-you-can-eat buffet.   "
64537|NCT02440919|"     This is a double crossover study where all patients are randomly allocated to one of two     treatment sequences associated with endotracheal aspiration.The first treatment (A) uses two     suctioning methods for each patient: one involving hyperoxygenation with administration of     100% oxygen 1 minute before and after suction (intervention I), and the other     hyperoxygenation with oxygen supply to 20% above basal offer (Intervention II) in the same     way.The second treatment (B) uses a technique of hyperinflation with the mechanical     ventilator (PEEP-ZEEP) associated with hyperoxygenation. The intervention I, uses PEEP-ZEEP     offering 20% above basal oxygenation and intervention II uses the PEEP-ZEEP with basal oxygen     supply in the same way.      All subjects were randomly allocated using sealed envelopes to a treatment sequence A or B on     Day 1. Patients received two treatments, at least four hours apart. The first treatment is in     the morning and the alternate treatment is performed in the afternoon. On Day 2 the order of     the treatments was reversed using the same patient position sequence.The interventions I and     II are performed at least 4 hours apart to minimize any carryover effect.   "
64538|NCT02440906|"     The Wellness Incentives and Navigation (WIN) project is designed to help improve health     self-management and reduce the incidence and consequences of chronic disease among     non-elderly adult Medicaid Supplemental Security Income (SSI) beneficiaries. WIN targets SSI     beneficiaries with behavioral health (mental health and substance abuse) diagnoses. Research     demonstrates that these individuals are more likely to suffer chronic physical     co-morbidities, experience debilitating chronic illnesses earlier in life and have elevated     healthcare costs.      WIN uses person-centered wellness planning and navigation facilitated by trained,     professional health Navigators, dedicated specifically to the WIN project, who use     Motivational Interviewing (MI) techniques, and a personal wellness account. Participants with     more serious mental illnesses will be offered additional support in the form of Wellness     Recovery Action Planning (WRAP) to enable them to take full advantage of person-centered     wellness planning.   "
64539|NCT02440893|"     The study goal was to understand the effect of Metformin on Corus® CAD (henceforth Corus)     in pre-diabetic patients who are medication naive. This study provided data to determine if     the Corus gene expression signature was different in pre-diabetic patients when metformin was     newly prescribed and taken.   "
64540|NCT02440880|"     Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of     the hospital resources and the continuous need to decrease the costs, work load and medical     stuff engagement. One of the most common problem is the need to control pain post     operatively, this issue increase the work load over the pain management team and increase     lead to patient in satisfaction.      This study will test the usage of dexamethasone with different doses (4 and 8 mg) either     locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis     plane) block to prolong the duration of the block and decrease the need of post-operative     analgesics.   "
64541|NCT02440867|"     The purpose of the study is to test a new treatment of social cognition deficits in patients     with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation     (theta-burst). The study will also identify clinical variables, cognitive and psychomotor     most sensitive to treatment, to estimate the most sensitive treatment target, assess     tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on the     brain a multimodal imaging study and compare the imaging variables (resting network,     Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients     before treatment and healthy subjects.   "
64680|NCT02439047|"     The objective of this study, which will be realised in vitro on human samples, is to test 2     cell sources isolated from peritoneum for adult mesothelial cells (peritoneal samples) and     from adipose tissue for the adipose stem cells (adipose tissue samples). The latter will be     differentiated towards the mesothelial phenotype and morphotype. The 2 routes will be     compared and the most satisfactory one will be chosen to make a non-stick patch.   "
64542|NCT02440854|"     This non-interventional study will include a representative sample of patients with locally     advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in     Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment     with the study medication (afatinib, GIOTRIF®) will be treated according to the local     prescribing information and standard medical practice in terms of visit frequency and types     of assessments performed.      The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related     symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting in     Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale (LCSS)     in eligible patients, after 6 months of therapy, will be analyzed.      The overall study duration period is expected to be 48 months, including a 36-month     enrollment period and a minimum 12-month follow-up period.   "
64543|NCT02440841|"     The purpose of this study is to investigate the potential for co-administration of strong     inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.   "
64544|NCT02440828|"     This study evaluates the addition of tobramycin inhalation treatment to standard intravenous     therapy in the treatment of ventilator associated pneumonia.   "
64545|NCT02440815|"     The specific focus of this study is to gather data regarding the effects of a psychological     therapy known as Problem Solving Therapy (PST) on cerebral blood flow (CBF), cortical gray     matter (GM) atrophy, subcortical white matter (WM) lesion burden, and measures of cognitive     function in subjects with Late Life Major Depressive Disorder (LLD). This research goal will     be achieved by recruiting 110 individuals over the age of 65 with LLD. The primary outcomes     will be change in CBF, change in GM atrophy, change in WM lesion, change in cognitive     function, and change in depression severity from baseline to the end of 12 weeks of PST.   "
64546|NCT02440802|"     Androgen deprivation therapy (ADT) by surgical castration or administration of LHRH agonists     or antagonists is the gold-standard systemic treatment of Prostate Cancer. The efficacy,     severity and frequency of side effects of ADT vary from a patient to another. The exact cause     of this variability is not known, however certain genetic polymorphisms affecting enzymes     implicated in the synthesis and metabolism of sex-steroids seem to be involved in these     processes.      To perform a longitudinal study to evaluate the prevalence of various genetic polymorphisms     affecting genes in the sex-steroid synthesis and metabolism pathway (CYP1A1, CYP1B1, CYP19A1,     17HSD, HSD3B1, AR, ESR1, ESRRG, IL6, TNF-alpha) in men with Prostate Cancer receiving ADT and     the possible association between polymorphisms and frequency and severity of side-effects of     ADT.   "
64547|NCT02440789|"     The purpose of this study is to find out about the safety of sirolimus in individuals with     HIV infection who are also being treated with ART. The investigators want to learn whether     sirolimus will decrease inflammation and immune activation in the body; whether sirolimus     will change the level of HIV in the participants' blood; and how sirolimus interacts with ART     in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent     organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus     has also been used for the prevention of complications after stem cell transplants and as a     treatment for certain kinds of cancers in HIV-infected patients.   "
64548|NCT02440776|"     Monitor the safety and performance of the Pulsante Microstimulator System.   "
64549|NCT02440763|"     The key goals of EUROSCA-NHS is to determine and compare the rate of disease progression in     SCA1, SCA2, SCA3 and SCA6 including determination of the order and occurrence of non-ataxia     symptoms, assessment of activities of daily living (ADL) and quality of life (QoL), and     identification of predictors of disease progression and survival.   "
64550|NCT02440750|"     The presence of a thin endometrium has an important role in allowing the best conditions for     hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day     administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial     preparation to operative hysteroscopy.   "
64551|NCT02440737|"     This pilot clinical trial studies the Navigated Early Survivorship Transition (NEST)     intervention in improving survivorship care planning in patients with newly diagnosed cancer     and their caregivers. A survivorship care planning session (SCPS) delivered to survivors and     their primary caregivers may improve psychosocial well-being, patient and caregiver     engagement, and adherence to treatment and follow-up recommendations. It is not yet known     whether a NEST intervention or usual care is better in improving survivorship care planning     in patients with newly diagnosed cancer.   "
64552|NCT02440724|"     The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).   "
99897|NCT01978561|"     The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in     subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.   "
64553|NCT02440711|"     The goal of this study is to evaluate endurance, walking performance, mobility, and perceived     exertion of transtibial prosthesis users (i.e., study participants) walking with a     conventional energy storing prosthetic foot (ESF) and a novel modified running-specific     prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF     provides superior performance to the ESF, which is commonly prescribed to most active     individuals with lower limb amputation.   "
64554|NCT02440698|"     The investigators will use a web-based survey to collect data on individual attitudes and     self-reported health behaviour changes following genetic testing for personalized nutrition.     Participants (n=80) are employees of a large multi-national food company's R&D division     located in Australia, Switzerland, USA and the UK. They underwent a genetic test for     personalized nutrition in March 2015 that was offered at no cost through the company wellness     program. A registered dietitian completed a pre-test consultation and disclosed the test     results with DNA-based dietary advice. The test provided information on 7 components of diet     and additional information on individual risk for gluten intolerance.   "
64555|NCT02440685|"     This study is a dose escalation, and cohort expansion study in subjects with advanced cancer     for which no standard therapy exists. Subjects must have received prior treatment for cancer     that has not worked, or has stopped working.   "
64556|NCT02440672|"     The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR     Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total     knee replacement.   "
64681|NCT02439034|"     The results of the study will permit to set up a standardized and validated procedure of pain     management authorizing medical and paramedical staff of brachytherapy department to handle     pain and in this way to improve the quality of life of the patients.   "
64557|NCT02440659|"     Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to     identify factors that matter the most to patients with kidney disease and study how they are     impacted by different types of dialysis. The inclusion of patients, caregivers, and patient     advocacy organizations as research partners will assure that the study addresses questions of     greatest relevance to patients facing the need for dialysis.      Aim two is based on preliminary results of Aim one interviews, and in collaboration with the     Patient Advisory Panel, the investigators developed a brief questionnaire to be administered     to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal     Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the     questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and     peritoneal dialysis (PD).   "
64558|NCT02440646|"     In a prospective cohort single-center observational study, 720-1080 chest pain patients     ('all-comers' REALITY registry of CTA patients, Ural Institute of Cardiology, Yekaterinburg,     Russia; www.cardio-burg.ru) with or without acute coronary syndrome will be enrolled who     admitted to the chest pain outpatient center (The Heart Clinics, Yekaterinburg, Russia;     www.hclinic.ru) between September 2010 and May 2015 underwent functional testing and computed     tomography angiography, and/ or 3D quantitative coronary angiography with or without further     percutaneous coronary intervention. Subsequent plaque burden/ % stenosis (adjusted with     technical limitations of CTA and 3D QCA), major adverse cardiovascular events (death from     cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due to unstable     or progressive angina) will be judged to be related to either originally treated (culprit)     lesions or untreated (non-culprit) lesions. Moreover, the clinical potential of CTA vs 3D QCA     in two real-world patient flows of the Chest Pain center will be estimated with the special     focus on safety (contrast-induced nephropathy, radiocontrast-induced thyroid dysfunction, and     radiation dose). The diagnostic accuracy of both CTA and 3D QCA will be analyzed in deceased     patients.      The follow-up period will achieve 3-5 years when retro- and prospectively collected clinical     events and imaging outcomes will be determined at the hospital, in 1, 6, 12, 24, 36, 48 and     60 months after the first imaging examination.      The independent ethics expertise will be provided by the Ural Medical University,     Yekaterinburg, Russia (www.usma.ru). The monitoring of the clinical data with imaging as well     as further CoreLab expertise (software of Medis) will be provided by De Haar Research     Foundation, Rotterdam, the Netherlands.   "
64559|NCT02440633|"     To obtain absorption, metabolism and excretion data for parent drug and any metabolites.   "
64560|NCT02440620|"     This study will describe the epidemiology including prognosis of heart failure related to     treatment with anthracycline and trastuzumab for breast cancer.      In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer     patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered     advanced echocardiographic examination, test of bio-markers and genetic markers for the     purpose of investigating if early identification of patients in particular risk of developing     heart failure is feasible.   "
64561|NCT02440607|"     Clinical decision support tools with in the electronic medical record can improve clinical     care processes. To date, there is little evidence evaluating crisis management with such     decision support tools. The investigators aim to create an electronic cognitive aid with     embedded decision support to aid clinicians during the management of a crisis. In order to     test the effectiveness of this tool, investigators seek to compare the simulated medical     management of a crisis (malignant hyperthermia) using a traditional cognitive aid (laminated     card) versus a dynamic electronic visual aid with decision support.   "
64562|NCT02440594|"     The purpose of the current project is to evaluate the impact of the PACE/PACENET BHL clinical     program on older Pennsylvanians and to evaluate the feasibility and impact of an enhancement     to the current clinical program. In order to meet this objective, the following primary     questions will be addressed in the current project: Is the current PACE/PACENET BHL Clinical     Program associated with improvements in behavioral health outcomes among older adults newly     prescribed an antidepressant, antipsychotic, or anxiolytic? Is the current PACE/PACENET BHL     Clinical Program associated with improved access to and delivery of evidence-based care? Is     the Enhanced PACE/PACENET BHL Program associated with better outcomes than the current     PACE/PACENET BHL Clinical Program?   "
64563|NCT02440581|"     Renal osteodystrophy (ROD) represents the bone histologic abnormalities resulting from loss     of renal function. It starts early during the loss of kidney function and is seen in     virtually all chronic end stage kidney disease patients on dialysis (CKD-5D). A major     component of ROD is bone loss leading to chronic kidney disease (CKD) associated     osteoporosis. Debilitating hip fractures occur in patients with CKD at a rate 4.4 times     higher than in the general population, with associated high costs, morbidity and an annual     mortality of 64%. CKD osteoporosis is distinctly different from post-menopausal osteoporosis.     Presently, no uniformly accepted CKD osteoporosis treatment protocol exists because of     challenges related to racially specific bone turnover states. Therefore, most physicians are     reluctant to treat this disorder despite the profound impact on health and quality of life,     and its association with vascular calcifications. These vascular calcifications confer an     increased risk for cardiovascular events which are the major cause of the over 20% annual     mortality rate in CKD-5D patients.      The goal of the proposed controlled randomized study is to test the concept that CKD     osteoporosis can be successfully treated when treatment is individualized by patients'     turnover status. The study will demonstrate that reversal of bone loss can be achieved by     increasing bone formation in low turnover patients, and by reducing bone resorption in normal     or high turnover patients. A second aim of this study is to provide new information whether     these treatments will also retard progression of vascular calcifications. Blood tests     measuring FGF23, indicators of Wnt pathway activity, bone resorption and formation will be     followed to understand potential mechanisms and to evaluate their usefulness for prediction     of changes in bone mass and vascular calcifications.      CKD-5D patients with established osteoporosis will be enrolled into one of two treatment arms     based on bone turnover status. Each arm will be adaptively randomized by race, age and gender     into treatment or control groups. In the low turnover arm, teriparatide combined with     cinacalcet will be given, and in the normal or high turnover arm, alendronate will be     administered. Bone mineral density will be measured at baseline and after one year of     treatment by quantitative computed tomography. Calcifications of the coronaries, aorta and     heart valves will also be measured at the same times by multi-detector computed tomography.      If this proof-of-concept study is successful, it will offer a heretofore unavailable     treatment for osteoporosis in CKD-5D patients thus changing the prevailing clinical practice     paradigm. This will provide immediate benefit to CKD patients by reducing fracture risk, bone     pain, and cardiovascular risk, while greatly improving their quality of life. These     improvements will also convey major socioeconomic benefits by decreasing the high associated     treatment costs. The proposed study is highly relevant to the National Institute of Diabetes     and Digestive and Kidney Diseases' mission of disseminating science-based information to     improve the health and quality of life for patients with endocrine, metabolic and kidney     diseases.   "
64564|NCT02440568|"     This is a dose escalation study to evaluate Omacetaxine when given in combination with a     standard induction regimen of 7+3 (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in     patients with newly diagnosed acute myelogenous leukemia (AML).   "
64565|NCT02440555|"     Type 2 diabetes is the chronic disease with the most important development in France, and     particularly in the Saint-Etienne area due to his specific population.      Different studies showed the interest of screening targeted on high risk population to reduce     cardiovascular risks and mortality.      The current screening recommandation is an opportunist targeted screening on population older     than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire     screening targeted on population older than 45 years suffering precarity with or without risk     factors by capillary blood glucose or fasting glucose.      The objective of the Sainté Diabete network is to optimize the screening of diabetics, their     follow-up and their treatments. Using a self-administered questionnaire during a medical     visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.   "
64566|NCT02440542|"     The purpose of this study is to evaluate outcomes of popliteal nerve blocks for postoperative     pain control in patients undergoing ankle and hindfoot reconstruction surgeries. The     following outcomes will be analyzed: length of hospital stay, level of pain control, pain     medication use, complications, and patient satisfaction.   "
64567|NCT02440529|"     In this study, the investigators are interested in evaluating the impact of an orthopaedic     related smoking cessation discussion after fracture surgery.   "
64656|NCT02439372|"     Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis     flare, as a flare-worsening factor or simple bystander, are debated. Theoretically,     CMV-specific cell-mediate immune response will further categorize the patients into high or     low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific     ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV     colitis on ulcerative colitis flare.   "
64568|NCT02440516|"     Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS)     and the most common cause of non-traumatic disability in young adults in western countries.     Despite increasing therapeutic options to ameliorate the disease course, most patients suffer     from persistent neurological deficits over time.      Disability in MS has a negative impact on patients life's impairing activities of daily     living (ADL) and quality of life (QoL) and leading to loss of work and the need providing     care. This results in tremendous socioeconomic burden.      Disease-modifying treatments prevent disability progression in variable extent. However no     drugs are available ameliorate persistent disability in MS. Therefore, exercise training as     well as physical and occupational therapies are important in the symptomatic treatment of MS.      Physical and occupational therapy is usually performed close to patients home by therapist     with different professional background in a non-standardized way.      The investigators therefore aim to develop a standardized comprehensive ambulatory     neurorehabilitation program, integrating task oriented circuit training for MS patients to     improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital     settings.   "
64569|NCT02440503|"     The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that     included breastfed infants consuming different infant solid foods. The investigators results     showed that different solid foods, especially the protein content of the food, is important     on infant's gut bacteria profile and growth. Although the first year of life is critical in     obesity development later in life, data are very limited on the effect of protein from solid     foods, an important component of infant diet, especially in breast-fed infants. In this     study, the investigators will re-contact these participants, who are now in their early     childhood (~5 years old), to evaluate the long-term effect of various macronutrient     quantities in solid foods, by assessing the participants' growth, body composition, and gut     bacteria profile.   "
64570|NCT02440490|"     Cognitive difficulties often occur with chronic pain. The aim of this randomised controlled     trial is to determine whether various aspects of cognitive function can be improved. An     8-week course of cognitive training via a web-based training program (3 times per week) will     be contrasted with watching informative documentary videos (for the same length of time).     Outcomes include subjective and objective measures of cognition, as well as self-report     measures of mood and pain.   "
64571|NCT02440477|"     Background: Shoulder pain is the third most common musculoskeletal problem accounting almost     21% of all musculoskeletal complaints. Symptomatic Rotator cuff degenerative tears (RCDT) are     mostly common above the age of 40. Deviations of posture in the upper quadrant such as,     slouched posture and forward head position, have been linked repeatedly to rotator cuff     diseases, altered scapular kinematics and changes in the acromiohumeral distance (AHD). No     study yet examined the effect of changing posture in sitting on the output of shoulder     clinical tests, in patients with RCDT.      Objectives: The primary objective of the study is to examine the effect of changing posture     in sitting on selected clinical shoulder tests in patients with rotator cuff degenerative     tears (RCDT) Study design: A single blinded controlled clinical trial Methods: A total of 100     subjects (Patients referred to physiotherapy outpatient clinics of Clalit Healthcare Services     in Holon and Hertzlyia) will be included in this study and divided into 2 groups: 50 subjects     with shoulder pain who are diagnosed with RCDT by ultrasound and a control group of 50     volunteering subjects without any pain in the upper quadrant. All patients will be measured     for their body weight and height and their hand dominance will be notified. Following     reliability trials on the first 10 subjects, all subjects will be tested for pain provocation     and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for     the diagnosis of rotator cuff diseases (Empty can - sensitivity=94%, specificity = 46% Neer     test - sensitivity = 72%, specificity = 60%, and Hawkins-Kennedy test - sensitivity = 79%,     specificity = 59% ) in 3 sitting postures; normal resting posture, slouched posture, and     upright posture with scapular retraction as described by Kalra et al (2010). In addition, the     rotator cuff muscle strength tests during shoulder abduction, internal rotation and external     rotation will be measured for the 2 shoulders using a hand-held dynamometer.   "
64572|NCT02440464|"     This study is designed to compare progression-free survival (PFS) from randomization among     patients randomized on the BMT CTN 1302 protocol, Multicenter Phase II, Double-blind Placebo     Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell     Transplantation for High Risk Multiple Myeloma. It is hypothesized that Ixazomib maintenance     therapy will result in improved PFS in patients with high-risk multiple myeloma following     Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) compared to placebo.   "
64584|NCT02440308|"     This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent     for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively     PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called     68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces.     The PET scanner takes pictures that capture where the radioactive drug is lighting up and     attaching to tumor cells, which may help doctors recognize differences between tumor and     healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside     the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow     doctors to identify smaller tumors than standard imaging.   "
64573|NCT02440451|"     This study aims to demonstrate that fMRI neurofeedback training improves the identification     and comprehension of emotional facial expressions (and overall social behaviour) in subjects     with ASD.      The intervention setup provides structured presentation of emotional facial expressions and     the associated tools for mental imagery. The investigators hypothesize that the     accomplishment of the proposed competence training improves the subjects ability to     comprehend facial expressions, identify emotions and be able to correctly express them.      Intervention Type is a Device (brain computer interface using brain imaging signals) and the     specific Intervention Name is Neurofeedback.      Structure: (1) initial eligibility screening, (2) pre-intervention (first week of study,     baseline outcome measures and additional evaluations), (3) intervention process (8 weeks),     (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up     (outcome measures at 6 months).   "
64574|NCT02440438|"     Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea     cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C.     difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited,     mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant     colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has     been implicated in large outbreaks with increased severity, frequent recurrence, and     significant mortality. The host immune responses can influence the severity of CDI and play     crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of     antibodies directed against the toxins A&B of C. difficile have been associated with a higher     risk of recurrence. However, there are conflicting reports.   "
64575|NCT02440425|"     The purpose of this study is to find out if the combination of Paclitaxel once per week with     Pembrolizumab once every 3 weeks will help participants with this disease. Researchers want     to find out the effectiveness of the drug combination to improve the delay of cancer     progression or death and compare it to historical data for weekly paclitaxel alone, and     assess safety.   "
64576|NCT02440412|"     This study evaluates the effect of a single session of Massage Therapy in salivary cortisol     level. All participants were assessed on three conditions: Massage session, rest in supine     position listening music, and under normal working conditions. The hypothesis of the     investigators is that the effect of the massage action in reduction of cortisol is superior     to only rest.   "
64579|NCT02440373|"     Cytochrome c is a mitochondrial protein that plays a key role in energy metabolism. When     mitochondria are injured, cytochrome c may leave mitochondria and reach the bloodstream. The     investigators plan to investigate whether circulating cytochrome c levels may serve as     biomarker of traumatic injury correlating with (1) severity of traumatic injury, (2)     development of organ dysfunction, and (3) clinical outcomes. The Trauma Services at ALGH will     enroll over 8 months 100 consecutive trauma patients who require intubation for mechanical     ventilation and survive to hospital admission. The Resuscitation Institute at RFUMS will     measure cytochrome c levels in plasma taken upon hospital admission and subsequently at 24,     48, and 72 hours, with additional plasma stored for markers to be defined at a later time.     Blood cytochrome c levels will be analyzed in relation to severity of traumatic injury,     development of organ dysfunction, and clinical outcomes including survival and functional     status (adjusted for covariates such as age, gender, type of trauma, time to stabilization,     comorbidities, etc.) using information obtained as part of routine medical care. Successful     completion of this project will support blood cytochrome c as biomarker of traumatic injury     which could be used to identify severity, predict outcomes, and assess novel mitochondrial     protective strategies.   "
64580|NCT02440360|"     Santa Clara County has partnered with Abode Services to provide 112 units of permanent     supportive housing (PSH) for up to 6 years for chronically homeless individuals with multiple     co-morbidities who are high cost users of services in the County. Because the target     population of high cost users who are chronically homeless greatly exceeds the supply of     permanent supportive housing to be made available via this mechanism, the County plans to use     this opportunity to examine the effectiveness of PSH compared to treatment as usual by     ethically allocating a limited resource using a lottery type system for eligible individuals     who consent to participate in the Pay For Success (PFS) initiative. Specifically, while there     are estimated to be over 2,500 people in Santa Clara who would be eligible for participation     on any given night, the PFS program will only provide 112 PSH units at any given time. As the     study duration will last six years, the investigators anticipate that approximately 150-200     people will be housed via this mechanism. Outcomes will be reported to the Institutional     Review Board (IRB) on a quarterly basis and will be based on scheduled quarterly reports     provided to the county.      This evaluation will be a randomized controlled trial comparing the outcomes for chronically     homeless individuals randomized to receive PSH to those who are randomized to receive usual     care. The aims of this study are to:        1. measure months of stable tenancy for individuals who are placed in PSH;        2. examine differences in utilization of health services and the criminal justice system;          and        3. monitor the changes in use of longitudinal care.      All data utilized for this evaluation will be County administrative data. The investigators     hypothesize that some costly and acute health services utilization will decrease over time     for the intervention group, while other more sustaining health services will increase.   "
64581|NCT02440347|"     The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular     parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and     middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled     delivery in healthy volunteers.   "
64582|NCT02440334|"     The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound (CEUS)     can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation     compared to contrast enhanced CT or MR (the standard evaluation). This study involves the     off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the     vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine     post-cryoablation vascularity changes to screen for recurrent disease.   "
64583|NCT02440321|"     The purpose of this project is to develop and examine the effects of a parent-child     interactive program to decrease the level of children's exposure to environmental tobacco     smoke(ETS) at home, promote parents' and children's preventing strategy, knowledge of its     hazard and attitude against environment tobacco smoke. A clustered randomized controlled     trial was administered to school-aged children and their parents. The outcome indicators,     children's exposure to ETS at home and increase of strategy to prevent the exposure were     measured at baseline, 8 weeks, and 20 weeks. The other outcomes, parents' and children's     knowledge of and attitude toward ETS, family's anti-ETS climate and its influence, and     children's self efficacy of avoiding ETS were also measured at the same time point.   "
71597|NCT02348606|"     This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm     parallel group study of safety and efficacy of JZP-110 in the treatment of excessive     sleepiness in adult subjects with OSA.   "
64585|NCT02440295|"     The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time     tissue perfusion of lower extremity amputation sites and to develop parameters to predict     healing of amputations at the time of surgery.      This is a pilot study to see if the Spy Elite System is capable of recording accurate     measurements on amputation sites to allow some correlation to healing. If this study shows     promise for the device, the investigators would plan a larger study in which the data would     be assessed in the operating room at time of acquisition and revision performed if needed     based on the findings.   "
64586|NCT02440282|"     Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations     (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the     preferred modality of anesthesia. The use of sciatic nerve block has recently gained     popularity, however, without the supporting evidence of any benefits. This study was to     evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative     pain in diabetic foot patients undergoing minor LEA.   "
64587|NCT02440269|"     The purpose of this study is to determine whether the Circadian Rhythms effects on the     Norctrend Index in Anesthesia.   "
64588|NCT02440256|"     Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and     linkage to antiretroviral treatment. The EHOST study will evaluate a prescriber-focused     intervention to increase HIV testing rates, and optimize antiretroviral treatment,     re-engagement and retention outcomes among individuals engaged in OST. 46 OST sites in     British Columbia will be randomly allocated into three clusters. Clusters will initiative the     intervention at different time points, or steps, with every cluster receiving the     intervention.   "
64657|NCT02439359|"     A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability     of Single Intravenous Doses of CF-301 in Healthy Subjects.   "
64589|NCT02440243|"     Background There is limited evidence indicating that specific immunotherapy in elderly     patients is safe and effective. This study was performed to evaluate the safety and efficacy     of specific subcutaneous immunotherapy (SCIT) against grass pollen allergens in patients over     60 years of age with seasonal allergic rhinitis (SAR) and a confirmed allergy to grass     pollen.      Objective This study assessed the safety and efficacy of SCIT for grass pollen allergens in     elderly patients with SAR.      Methods This study included 62 60- to 75-year-old patients with SAR and grass pollen allergy     confirmed using a skin prick test, nasal provocation, and serum IgE measurement. The patients     were individually randomized to the active or placebo groups using a double-blinded method.     There were 33 subjects in the SCIT group (Purethal, Grass pollen, HAL Allergy B.V, Leiden,     Netherlands) and 29 subjects in the placebo group monitored for three years. The patients     were required to record each use of anti-allergy medication in a diary and use a visual     graphic scale. The main outcome measure was the area under the curve (AUC) for the combined     symptom and medication score (SMS).   "
64590|NCT02440230|"     To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with     exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.   "
64591|NCT02440217|"     Dilated cardiomyopathy (DCM) is characterized by a metabolic shift from fat to carbohydrates     and failure to increase myocardial glucose uptake in response to workload increments. The     investigators aimed at verifying whether this pattern is influenced by the presence of     abnormal glucose tolerance (AGT).   "
64592|NCT02440204|"     Intubation is a procedure that requires well relaxed muscles while general anesthesia is     performed. In order to get adequate muscle relaxation, remifentanil, sevoflurane or both     agents in combination have been reported as they can provide adequate conditions for     laryngoscopy and tracheal intubation without using muscle relaxants.      However, there were no previous studies to find the effective dose of sevoflurane in     combination with different bolus doses of remifentanil to obtain adequate endotracheal     intubation conditions without using muscle relaxants. The aim of this study is to investigate     the change in the minimum sevoflurane alveolar concentration which produces an adequate     endotracheal intubation condition when sevoflurane is combined with different bolus doses of     remifentanil used in clinical practice.   "
64593|NCT02440191|"     It has been not clinically determined whether TomoDirect was dosimetrically better than     3D-CRT for Asian patients with early breast cancer. Therefore, the objective of this study     was to compare dosimetric parameters of TomoDirect and 3D-CRT in early breast cancer patients     of an Asian cohort.   "
64594|NCT02440178|"     The purpose of this study is to determine whether prophylaxis with micafungin is effective in     the induction chemotherapy for newly diagnosed acute leukemia patients.   "
64595|NCT02440165|"     Early nursing nutrition intervention for outpatients in need of surgery        -  Objective - To investigate the feasibility and effectiveness of screening and an early          nursing intervention on malnutrition in outpatients in need for surgery.        -  Design - Multi-centre cluster-randomised controlled early trial design (n=150 patients)        -  Intervention - Malnutrition screening (during outpatient clinic visit) and (in case of          patients being ´at risk for malnutrition´ or being ´malnourished´), a nutrition care          plan (including nutritional drinks and energy and protein rich meals) tailored to          individual patient requirements        -  Comparison - Usual care (no nutritional care plan)   "
64596|NCT02440152|"     The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and     the initiation of relapse after detoxification. There is evidence that deep brain stimulation     (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via     inhibitory action .      The investigators hypothesise that bilateral stimulation of the NAcc will significantly     reduce withdrawal symptoms and thus enable the patients to substantially decrease their     Levomethadone usage.   "
64607|NCT02440009|"     The study evaluates the addition of itraconazole to glucocorticoids in management of acute     stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will     receive glucocorticoids while the other half will receive itraconazole and glucocorticoids   "
64608|NCT02439996|"     The objective of this study is to investigate the effect of different doses of intravenous     immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a     multicentre, prospective,randomised trial.   "
64609|NCT02439983|"     The study is designed to evaluate the effects of the proprietary nutritional supplement on     cognition, mood, and brain imaging parameters following a relatively short period of     treatment.   "
64597|NCT02440139|"     STUDY DESIGN:      This is a retrospective, multi-reader, multi-case, (MRMC) randomized reader study.      OBJECTIVE:      Primary: The primary objective of this clinical study is to prove that a user aided with     ClearRead CT InSight (CRCTI) is superior to the unaided reader for detecting actionable lung     nodules.      Secondary: The secondary objective of this clinical study is to prove that the reader's     reading time is not significantly increased when aided with CRCTI.      NUMBER OF SUBJECTS:      Retrospective CT studies from approximately 300 patients will be included in the study.     Approximately 100 true positive cases and 200 normal cases.      NUMBER OF READERS:      A reader study with at least ten (10) participating radiologists (US Board Certified) will be     conducted.      PRIMARY ENDPOINTS:      Scores given by the radiologists with and without ClearRead CT Insight will be recorded and     compared to the true status of the study-cases. The frequency of the scores for each method     (Unaided, Aided) will be tabulated and LROC curves constructed along with sensitivity,     specificity, PPV, NPV and clinical actions. Additionally, machine nodule detection rate and     false positives per patient on normal cases will be measured.      PATIENT POPULATION :      The study will target approximately one hundred (100) patients whose CT nodules were shown to     be cancer and two hundred (200) normal patients. The patient population will be consistent     with the national lung cancer screening protocols.   "
64598|NCT02440126|"     The purpose of the study is to develop an improved understanding of the long term     pharmacokinetics and pharmacodynamics of natalizumab with both standard dosing and extended     dosing, and collect additional samples to explore cell-based biomarkers of natalizumab     treatment and PML risk.   "
64599|NCT02440113|"     Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix     Endoprosthesis.   "
64600|NCT02440100|"     This is an investigator-and-subject blind, phase 1 study to characterize the safety,     tolerability, pharmacokinetics and central and peripheral pharmacodynamics of 14-day repeated     ascending doses of PF-06648671 once a day in healthy adults (part 1) and repeated doses at     the maximum tolerated dose (MTD) defined in part 1 in healthy elderly subjects (part 2). The     study also include an optional cohort (part 3) to evaluate the drug interaction between     PF-06648671 at MTD and CYP3A probe, midazolam   "
64658|NCT02439346|"     Determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics (PK),     and/or recommended Phase II dose (RP2D) of oral BAY 1143269 given alone or in combination     with intravenous (IV) docetaxel in subjects with advanced solid tumors.   "
64601|NCT02440087|"     This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients     will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes     will be performed at 1 month, 3 months, 6 months and 9 months.      This observational study is non-interventional, it does not change the usual care of patients     who underwent a bariatric surgery. Data collection will be carried out during routine visits     planned in the post-operation usual follow-up. The blood tests are part of the patient's     usual care for his bariatric surgery.      Surgeons will include patients for whom they have freely decided to use the dietary     supplement Refill under the care of the treatment of obesity. The motivation of the patient     and his commitment to the project is evaluated by the surgeon.      The main objective is to evaluate the efficacy of the dietary supplement Refill.      The primary endpoint is the reduction of iron deficiency.   "
64602|NCT02440074|"     This trial pretends to validate for clinical use a bioengineered product composed of     mesenchymal stem cells produced by the Instituto de Biologia y Genetica Molecular (IBGM),     Valladolid (MSV, which have already been approved by the Spanish Regulatory Agency for three     previous clinical trials) and a cross-linked matrix of autologous plasma patented by The     Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These     two groups collaborate in the present project with the team of Maxillofacial Surgery of the     Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the     medical aspects. The proposed trial is based on positive results obtained in previous animal     studies performed by the present multidisciplinary team. A phase I / II clinical trial with     10 patients suffering from bone cysts in the maxillofacial region is proposed. Autologous     mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous     plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery     and the cavity filled with the protein matrix containing the mesenchymal cells. Follow up     tests will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by     panoramic radiography and computerized tomography scan.   "
64603|NCT02440061|"     Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this     research study is to determine the role of this gut hormone in the regulation of insulin     secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize     that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat.     The investigators will compare insulin secretion and glucose changes during meal ingestion     while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein     on separate study days. AG is a form of the ghrelin hormone that has a small modification to     it that allows it to bind to a specific receptor. The investigators hypothesize that AG has     an effect on how the body handles glucose after a meal. AG has been approved by the U.S. Food     and Drug Administration (FDA) for human research only. This study will also involve the use     of a medicine called arginine, which is a naturally occurring product and found in many     nutritional supplements. Its use in this study is investigational. The use of arginine helps     maximize insulin release from the pancreas so the investigators can better examine whether AG     affects insulin secretion.   "
64604|NCT02440048|"     To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after     tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the use     of bovine bone substitute (BioOss®) and to extration only as negative control.   "
64605|NCT02440035|"     The purpose of this study is to assess the safety and tolerability of intramuscular     homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored     vaccine candidate) and Ad26.RSV.FA2 in healthy participants.   "
64606|NCT02440022|"     This prospective, global, multicenter, randomized, controlled study is designed to evaluate     the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared     to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic     abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.   "
64612|NCT02439944|"     This study involves the use of personalized nicotine patch dosing as a treatment strategy for     smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose.     Functional Magnetic Resonance Imaging scans will also be obtained from all study participants     before and after treatment. The first aim of the study is to determine if the treatment     method under investigation is safe and more effective at increasing quit rates in smokers who     do not respond to standard therapy.The second aim is to determine if there are any treatment-     or cessation-related changes in brain function.   "
64613|NCT02439931|"     Survivors of high grade brain tumours frequently experience increases in distress, cognitive     challenges, and lessened quality of life. At the same time a range of barriers can make it     challenging for these individuals to come into the clinic for appropriate psychosocial     support. The proposed study is therefore a feasibility study that is designed to develop a     manualized, remotely delivered psychosocial intervention for this population and then to test     the acceptability, feasibility, apparent efficacy, and areas for improvement of the developed     intervention. Further, a remote neuropsychological testing procedure will be developed and     implemented and analogous questions will be asked around this procedure.   "
64614|NCT02439918|"     Kinshasa, Democratic Republic of Congo (DRC), is where human immunodeficiency virus type 1     (HIV-1) appears to have most diversified. The factors that lead to jumpstarting the HIV-1     epidemic remain unclear; mounting evidence suggests medical interventions may have     contributed. Hepatitis C virus (HCV) and human T-cell lymphotropic virus type 1 (HTLV-1) are     viruses compatible with long-term survival but with broadly similar modes of transmission as     HIV. The main objective was to assess the association of past intravenous treatment with HCV     and HTLV-1 seropositivity. The investigators hypothesized that medical interventions in the     mid-20th century may have facilitated the emergence of HIV-1 in central Africa.      To assess the association of injectable treatments with HCV and HTLV-1 infection and to     reconstruct past virus dynamics, the investigators conducted a cross-sectional study of 839     elderly long-term inhabitants of Kinshasa, with serological assays followed by amplification     and sequencing. Risk factors were assessed through logistic regression. Phylogenetic methods     were used to reconstruct the epidemic history of HCV.   "
64615|NCT02439905|"     During lung surgery, mechanical one-lung ventilation is usually mandatory to provide     appropriate surgical condition. However, not only mechanical ventilation is associated with     inflammatory response, but also one lung ventilation will result in detrimental effects such     as ischemia and reperfusion injury, and systemic inflammatory responses.      Dexmedetomidine is an alpha-2 selective agonist. It was reported that dexmedetomidine     decreased reperfusion injury, reduce the release of proinflammatory mediator and protected     lungs from reperfusion injury in esophageal cancer patients who undergoing one lung     ventilation from reducing oxidative stress metabolites. However, other details of protective     effects is still unknown.      High mobility group box 1 (HMGB1) is an important proinflammatory factor. It was found to be     related to ventilator induced lung injury in several condition. Animal studies also showed     that dexmedetomidine reduces the expression of messenger ribonucleic acid in     lipopolysaccharide-activated macrophage so that decrease the amount of HMGB1 release.     However, clinical trials about these are still lacking.      In this study, we will investigate the protective effects of dexmedetomidine to patients     undergoing video-assisted thoracoscopic surgery, especially on the specific inflammatory     markers- plasma HMGB1 and other inflammatory cytokines (eg. interleukin-1. interleukin-6).     This will let us to know the role of HMGB1 during one-lung ventilation injury and the effect     of dexmedetomidine in regulating the release of HMGB1. This study will become a basis of     further medical therapy in treating inflammation.   "
64616|NCT02439892|"     Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain     and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight     loss is attributed to lean muscle wasting that is associated with decline in physical     function, substantial fatigue and significantly decreased quality of life. Rehabilitation     that includes physical exercise, nutritional counselling and oral nutritional supplements     (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot     randomised trial is to assess feasibility, evaluate patient experiences and assess     preliminary effects on muscle mass, physical function, nutritional status and quality of life     of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC     patients referred for curative RT with or without chemotherapy, will be randomised to a)     rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be     carried out at an outpatient facility during the treatment period (6-7 weeks) and     rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.   "
64617|NCT02439879|"     Patients with diabetic neuropathy and total symptoms score(TSS) >7 points were invited to     this open multicenter study. Patients were free of pain medications and severe diabetic     complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a     decrease >3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no     medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change     in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the     end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and     the frequency of use of rescue medications. Physicians were free to manage glucose to     maintain Hba1c close to the ADA target (HbA1c <7%).   "
64618|NCT02439866|"     Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized     into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules     filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received     methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a     day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group     3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow     rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural     outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity     was the main outcome measure, and mean deviation index of visual field test and peripapillary     retinal nerve fiber layer thickness were secondary outcome measures.   "
64619|NCT02439853|"     This is a study on Internet-based video-practice speech and language therapy for persons with     primary progressive aphasia (PPA), Alzheimer's disease (AD), behavioral-variant     frontotemporal dementia (bvFTD), or related conditions.   "
64620|NCT02439840|"     In the previous study, the investigators obtained the cutoff value of Bispectral Index to     detect early deep sedation in patients with mechanical ventilation. Bispectral Index     monitoring can be used as an adjunct tool in screening and confirming deep sedation during     the early period of mechanical ventilation. In present study, validation test will be carried     out to clarify the sensitivity and specificity of obtained cutoff value in screening deep     sedation in patients with mechanical ventilation.   "
64654|NCT02439398|"     Development of myocardial reparative therapy for the treatment of acute ischemic cardiac     disease, based on the intracoronary administration of allogeneic Cardiac Stem Cells (CSCs) to     ameliorate myocardial cell death and promote cardio-regeneration.      The study comprises two phases:        1. Initial dose-escalation open-label safety phase comprising 6 patients. Escalation will          start with the Maximum Recommended Safe Dose (MRSD) calculated from Non-Observed Adverse          Events Level (NOAEL) and it is expected to finish with the target dose (TD). There will          be no placebo group for this initial phase.        2. Randomized double-blind placebo-controlled safety and efficacy phase in which the TD          will be injected if the dose-escalation phase is completed successfully.   "
64621|NCT02439827|"     Background:      Interventions on lifestyle among adolescents are important, but the main mechanisms that     explain the changes (mediating variables) on lifestyle have been little explored.     Investigators present the rationale and methods of a cluster-randomized controlled trial     aimed to promote promotion active and healthy lifestyle (especially physical activity [PA]     practice and reducing screen time use) among Brazilian students - the Fortaleça sua Saúde     (Strengthen Your Health in Portuguese) program.      Methods/Design:      This is a school-based cluster-randomized controlled trial that included students from six     elementary full-time public schools (7-9 grades) in Fortaleza, northeastern Brazil. The     intervention duration was one academic semester (approximately four months) in 2014. The     intervention strategies focused on teachers' training and activities on health in curriculum     (including a specific training to Physical Education teachers), active opportunities in the     school environment (availability of spaces and materials for PA) and health education     (production and exhibition of health material at school, and distributing pamphlets to     patients). Data collection will be performed before and immediately after 4 months of     intervention. The primary variables include the practice of PA (weekly PA volume) and the     screen time use (TV/computer/video games). Intrapersonal, interpersonal and environmental     variables associated to PA and screen time use will be evaluated by standardized     questionnaire. Other components of the lifestyle (e.g., eating habits), psychological (e.g.,     self-rated health, body satisfaction), biological (general and abdominal obesity) and     academic performance will be also evaluated in the patients. Depressive symptoms, eating     disorders, sleep quality, objectively-measured physical activity will be evaluated in obese     patients.      Discussion:      Is effective, this program will contribute to the development of public policies for active     and health lifestyle promotion among young population, especially from low- and middle-income     countries. The main variables (intrapersonal, interpersonal and/or environmental stimulus)     that help the young people to adopt an active lifestyle also may be indicated. Finally,     investigators expect that the proposed strategies may be adaptable to the public school     reality and they may be extended to the entire school system.   "
64622|NCT02439814|"     The cannabinoid delta 9-tetrahydrocannabinol (THC) is the primary psychoactive component of     marijuana. THC is believed to be a significant factor in the addictive potential associated     with marijuana use. In addition, attenuated levels of endogenous endocannabinoids have been     found in alcohol-dependent individuals as compared to social drinkers, suggesting that     changes in the sensitivity of the endogenous endocannabinoid system play a role in the     transition from recreational drug use to substance use disorders. Thus, pharmacotherapies     that target the cannabinoid system may be effective strategies for reducing marijuana use and     dependence. Recent preclinical data demonstrate that the neurosteroid pregnenolone (PREG)     inhibits THC activation of cannabinoid receptors and decreases symptoms of marijuana     intoxication. In addition, other studies show that PREG inhibits drug-seeking behavior. This     pilot study will provide important preliminary data on the effect of an acute dose of PREG on     cue-related craving in individuals with cannabis use disorder.   "
64623|NCT02439801|"     Laparoscopic cholecystectomy is accepted as gold standard in the management of     cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2     insufflation can cause decreased lung volumes and compliance, increased airway resistance and     impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects     of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and     elimination time of volatile anesthetic agent.   "
64624|NCT02439788|"     This research study is for patients that have a cancer called Neuroblastoma that has either     come back after treatment or did not respond to the standard medicines used to treat it. This     study combines two different ways of fighting cancer: antibodies and Natural Killer T cells.     Antibodies are types of proteins that protect the body from infectious diseases and possibly     cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that     can kill other cells, including cells infected with viruses and tumor cells. Both antibodies     and T cells have been used to treat patients with cancers. The investigators have found from     previous research that they can put a new gene into T cells that will make them recognize     cancer cells and kill them. In a previous clinical trial, the investigators made a gene     called a chimeric antigen receptor (CAR), from an antibody called 14g2a that recognizes GD2,     a molecule found on almost all neuroblastoma cells (GD2-CAR). They put this gene into the     patients' own T cells and gave them back to patients that had neuroblastoma. Nineteen     patients were treated on that study and there were no long term side-effects seen after the     GD2 T cell infusion. As the investigators have followed the patients over time, they noticed     that for those patients with disease at the time of their infusion, the time to progression     (the amount of time it takes before their neuroblastoma got worse) was longer in those whom     they could find GD2 T cells in the blood for more than 6 weeks after the last T cell     infusion. Because of this, the investigators think that if effector cells are able to last     longer, they may have a better chance of killing neuroblastoma tumor cells.      Natural Killer T cells are a special subset of innate lymphocytes that can effectively go     into tumor tissues of neuroblastoma. Inside the tumor, there are certain white blood cells     which help the cancer cells to grow and recover from injury. Natural Killer T-cells can     specifically kill these cells. In this study, Natural Killer T cells will be genetically     engineered to express GD2-CAR to attack neuroblastoma cells and the white blood cells inside     the tumor tissue.   "
64625|NCT02439775|"     The purpose of this study is to obtain an assessment of the efficacy and safety of renal     denervation in the presence of three standard antihypertensive medications.   "
64626|NCT02439762|"     The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT)     intervention compared to a Supportive Psycho-educational Control (SPC) condition in reducing     the frequency and intensity of suicidal thoughts and behaviors in Veterans with Substance Use     Disorders (SUDs) over a two-year follow-up period.   "
64627|NCT02439749|"     The purpose of this study is to obtain an assessment of the efficacy and safety of renal     denervation in the absence of antihypertensive medications.   "
64628|NCT02439736|"     The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1)     and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive     subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely     with traumatic brain injury (Glasgow Coma Scale score 9-15).   "
65004|NCT02434822|"     The aim of the study is to generate safety and immunogenicity data with Shanchol in The     Philippines      Objectives:        -  To describe the safety after each dose of Shanchol vaccine.        -  To describe the immunogenicity after each dose of Shanchol vaccine.   "
64629|NCT02439723|"     The FDA and Health Canada have approved regorafenib at a daily dose of 160mg for the     treatment of metastatic colorectal cancer and gastrointestinal stromal cancer; however, the     160 mg dose is not well tolerated by patients, especially women. The purpose of this study is     to determine if lean body mass and acidity in the intestinal tract impact how regorafenib is     absorbed into the bloodstream and then broken down and removed from the body. This may     explain the side effects experienced at the 160 mg dose, especially by women, and inform     regorafenib dosing in the future.   "
64650|NCT02439450|"     This study will test whether vaccination with viagenpumatucel-L combined with strategies to     modulate the immune response is safe for patients with non-small cell lung adenocarcinoma who     have failed at least one prior line of therapy for incurable or metastatic disease. These     methods collectively use the body's immune system to target the patient's own tumor.     Immunosuppression hinders than response, and may develop in NSCLC patients in a variety of     ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that     disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may     release this brake on the immune system. Tumor expression of PD-L1 plays an important role in     patient response to checkpoint inhibitors; in general, clinical response to checkpoint     inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes     (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's anti-tumor     activity while prolonging or increasing the efficacy of the checkpoint inhibitor.   "
64630|NCT02439710|"     The Patient Reported Outcomes, Burdens, and Experiences (PROBE) Study aims to develop a new     global tool to enhance the direct patient-voice in health care decision-making. Government     and private payers increasingly value data based on patient-centered outcomes research as     part of the overall cost-benefit evaluation of high-cost care and treatment of diseases such     as hemophilia. This emerging dimension of the healthcare environment presents a significant     opportunity and urgent need to improve patient organizations' ability to collect and     interpret relevant outcomes data. More robust patient reported data will improve advocacy     efforts to build comprehensive care programs, promote home treatment and implement     preventative treatment regimens thus allowing advocacy arguments to move beyond emotion and     anecdote to those grounded in real-world patient experiences and evidence. With the support     of the National Hemophilia Foundation, a global team of investigators will lead a patient     focused research project to investigate and directly probe patient perspectives on outcomes     they deem relevant to their care. Through PROBE, the investigators will develop and seek to     validate the reliability, reproducibility and responsiveness of a low cost, easily     administrable inventory for collecting patient self-reported outcomes, burdens and     experiences in living with hemophilia. The investigators anticipate that the metrics     established through PROBE will allow for comparison of patient outcomes within a country over     time and cross-sectionally between countries (regionally and globally).   "
64631|NCT02439697|"     This is a prospective single-arm open-labeled cohort study on dialysis patients of the     conversion from Aranesp® to NESP® for the treatment of anemia. The primary outcome of the     study is the haemoglobin level after conversion to NESP® after 6 months. Secondary outcomes     include the variability in haemoglobin level, average weekly dose of erythropoietin, safety     profile of NESP®, patients' subjective assessment of fatigue and injection pain after the     conversion.   "
64632|NCT02439684|"     This is a cross-sectional study that aims to assess the sensitivity and specificity of using     HbA1c as a diagnostic test for detecting the presence of diabetes mellitus (DM) when compared     to the use of oral glucose tolerance test (OGTT) among Hong Kong Chinese adult who have     impaired fasting glucose (IFG).      The investigators will recruit around 1000 non-diabetic adult participants who have impaired     fasting glucose (i.e. fasting glucose level between 5.6 to 6.9mmol/L) AND without symptoms of     hyperglycaemia to undergo both HbA1c test and oral glucose tolerance test after obtaining     their informed consent. A diagnosis of DM is confirmed when both the fasting glucose level     and 2-hour-post challenge plasma glucose level fall into diabetic range (i.e. fasting glucose     level ≥7.0mmol/L and 2-hour-post challenge plasma glucose level ≥11.1mmol/L) after a standard     75g OGTT. Participants with only 1 plasma glucose value within the diabetic range will be     invited to repeat an oral glucose tolerance test for confirmation of their diagnosis as     recommended by American Diabetes Association and World Health Organization. Demographic data     of the participants including age, gender, smoking status, medical history, diet and activity     level will be collected. Lipid profile, blood pressure, waist circumference and body mass     index will be checked and the total cardiovascular risk in 10 years will be calculated for     each participant using the Joint British Societies 2005 and Framingham 2008 equations to     evaluate the baseline cardiovascular risk of the participants.      These data will be analyzed using SPSS. The primary outcomes are the sensitivity and     specificity of HbA1c in detecting diabetes mellitus diagnosed by oral glucose tolerance test     (the gold standard). A receiver operating characteristic (ROC) curve will be obtained by     plotting sensitivity against (1-specificity) for each cutoff value for identification of an     optimal cutoff point. Diagnostic accuracy will be assessed by the area under the curve (AUC).     The differences in characteristics among participants diagnosed to have diabetes mellitus by     oral glucose tolerance test or HbA1c will be compared using independent t-test or χ2 test for     comparison between the 2 groups.   "
64633|NCT02439671|"     This study investigates a service delivery model to better support young adults with autism     spectrum disorders (ASD) in the transition from school to the community. The effectiveness of     the McGill Transition Support Program, a small-group format intervention (meeting once a     week for 2 hours over 10 weeks) focusing on communication, self-determination and working     with others skills, is measured by multiple pre- and post-program-assessments in a staggered     enrollment trial, a variant of a randomized controlled trial (RCT).   "
64634|NCT02439658|"     To assess the ability of common genetic variants in aggregate to predict drug-induced QT     prolongation in patients being loaded with dofetilide or sotalol, and validate the     feasibility of using a smartphone device for measuring QT interval.   "
64635|NCT02439645|"     This is a registry to examine genetic and clinical predictors of torsade de pointes events.   "
64636|NCT02439632|"     prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated     lower urinary tract infection in chinese   "
64637|NCT02439619|"     The aim of the project is to conduct a feasibility study of the mobile phone application     TechCare for individuals with psychosis in the North West of England.   "
64638|NCT02439606|"     This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to     manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients     undergoing elective non-cardiac surgery that required general anesthesia with orotracheal     intubation.   "
64639|NCT02439593|"     This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia     (study group) versus chemoradiotherapy alone (control group) following neoadjuvant     chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39     patients based on the expected overall 1 year survival advantage of +20% over the control     group (p0=40%).   "
64640|NCT02439580|"     Annona muricata L., include the leaves, is found to contain biologically active Annonaceous     acetogenins and plant polyphenols that are important components of human diet and a number of     them are considered to have chemopreventive and therapeutic properties against cancer.      To confirm previous findings in in vitro, animal study and traditionally use, a human, ex     vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of     A. muricata leaves extract for eight weeks.   "
64641|NCT02439567|"     The purpose of this study is to evaluate the effects of sustained virological response in     liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease     treated with new all oral antiviral drugs in order to determine factors implicated in     stiffness change and its implications for long-term follow-up.   "
64651|NCT02439437|"     This study looks at whether a coping skills training program can help women manage pain and     stress after breast surgery, and lower the risk of developing chronic pain. This coping     skills program includes eight training sessions that are done by telephone. These sessions     will focus on strategies for dealing with pain and stress, and how to apply these strategies     to subjects' own experiences.   "
64655|NCT02439385|"     Oral curcumin-containing supplement will be given to colorectal cancer patients with     unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to     completion of (or withdrawal from) chemotherapy.   "
64642|NCT02439554|"     This subproject is included in a project coordinated between program groups Evaluation of     Health Services of Epidemiology and Public Health (Project CAMISS). The overall objective is     to evaluate different aspects of health care received by patients with breast cancer from the     diagnostic process, treatment, complications, survival and quality of life, to provide     information to improve the effectiveness of interventions, reduce variability, have best     predictive rules and increase the quality of life. The main objective of the subproject is to     create and validate prospectively predictive rules of recurrence, complications, mortality,     changes in quality of life in these patients at admission and one/two years of treatment and     to evaluate the external validity of our rules to predict relapses, complications and     mortality in the retrospective sample of patients participating in screening programs.     Observational methodology with information available from a retrospective cohort of women     diagnosed between 2000 and 2009 and another 2-year prospective follow-up included 2040     incident cases of breast cancer in 18 hospitals of 5 regions. Cohorts will learn clinical and     health care diagnosis, tumor, treatment, hospital, follow-up (complications, relapse, and     vital status) cost and quality of life. Prediction rules are created by means of     regression/Cox models at the prospective sample and also investigators will assess the     external validity in the retrospective cohort in the case of recurrence, complications and     mortality. Expected results: There are currently no results of cohort analysis of the     diagnostic process of care that integrates different aspects. The study will create tools to     assist prognostic and therapeutic decision making process in these patients   "
64643|NCT02439541|"     Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem     cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.   "
64644|NCT02439528|"     The combined pulmonary fibrosis and emphysema syndrome (CPFE) individualized by our group in     2005 is characterized by an often severe dyspnea, almost exclusive male predominance, and     often major, profound impairment of gas exchange contrasting with preserved lung volumes and     absence of airflow obstruction, and a high risk of pre-capillary pulmonary hypertension     responsible for increased mortality. Almost all patients are smokers or ex-smokers. There are     some arguments in favor of genetic abnormalities in this syndrome of unknown etiology (other     than smoking) including short telomeres and mutations in the telomerase complex genes. There     are also emphysematous lesions, in patients with familial pulmonary fibrosis, with mutations     in the SFTPC gene (surfactant protein C), and reported cases of CPFE syndrome with SFTPC     mutation. No large genetic studies have been conducted to date in the CPFE syndrome. Our main     hypothesis is that the proportion of subjects with short telomeres is higher among patients     with CPFE syndrome than in subjects of similar age with idiopathic pulmonary fibrosis but     without emphysema. It has previously been shown that mutations in the telomerase TERT or TERC     genes are mostly found in people whose telomeres are abnormally short. The investigators     propose to use that test to identify patients most likely carrying a mutation, and to seek,     among them, the mutations in the TERT or TERC telomerase genes. The objective of the study is     to compare the proportion of patients with short telomeres in the group of patients with CPFE     syndrome to that of other patients (with idiopathic pulmonary fibrosis without emphysema, or     with emphysema without fibrosis).   "
64645|NCT02439515|"     The study proposes a novel rehabilitative program for the recovery of locomotor abilities in     post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a     biofeedback cycling training combining voluntary effort and Functional Electrical Stimulation     (FES) of the leg muscles, and a biofeedback balance training is superior to usual care in     improving walking abilities, disability, motor performance, and independence of post-acute     stroke patients. The innovative approach is to investigate whether interventions which do not     directly involve locomotor functions but movements similar in terms of kinematic patterns and     neural commands (e.g. pedaling), or aimed at recovering an essential prerequisite for     walking, such as postural control during upright stance, may improve and/or accelerate the     recovery of walking abilities.      A single-blind randomized controlled study is carried out. Participants are post-acute stroke     patients experiencing a first stroke less than 6 months before recruitment, with an adult     age, a low level of spasticity of the leg muscles (Modified Ashworth scale <2), no     limitations at hip, knee, and ankle joints, and able to sit up to 30 minutes. Subjects are     randomized to one of two groups, one performing the novel rehabilitative program in addition     to usual care (experimental group), and one performing usual care alone (control group).      The experimental program consists of 15 sessions of FES-supported voluntary cycling training     followed by 15 sessions of balance training. Both cycling and balance training are supported     by a visual biofeedback in order to maximize patients' involvement in the exercise and are     performed in addition to usual care.      The control group is involved in standard physical therapy which includes stretching,     muscular conditioning, exercises for trunk control, standing, and walking training, and upper     limb rehabilitation.      Both training programs last 6 weeks and patients are trained daily for about 90 minutes.     Cycling and balance training last about 20 minutes; thus, patients in the experimental group     perform only about 70 minutes of usual care.      Participants are evaluated at baseline (T1), after the end of the cycling training or after 3     weeks of usual care (post-treatment, T2), after the end of the whole intervention     (post-treatment, T3), and about 6 months after the end of the intervention (follow-up, T4).   "
64646|NCT02439502|"     The intent of this study is to evaluate the performance and usability of Fuse in routine     practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy)     gastrointestinal endoscopy procedures. The study is open label, prospective and Post     Marketing study.   "
65027|NCT02434523|"     The study will compare the effectiveness of amitriptyline versus placebo (inactive     medication) in treating chronic laryngitis.   "
64647|NCT02439489|"     PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K     pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K     (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive     towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I     PI3K-inhibitor.      The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120     and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic     advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially     head and neck, NSCLC, ovary, endometrial).      The primary objective of the study is to define the phase II recommended dose of daily oral     BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1     every 3 weeks.   "
64648|NCT02439476|"     Multiple myeloma (MM) is an incurable disease that is characterized by the accumulation of     clonal plasma cells in the bone marrow. While MM patients with relapsed disease may achieve     responses to subsequent antimyeloma therapies, the duration of response decreases with     successive relapses until resistant disease develops. Until recently, the median survival     following relapse after induction therapy was approximately one year. The relatively recent     US Food and Drug Administration (FDA) approvals of bortezomib (2003) and combination     lenalidomide plus dexamethasone (2006) therapies for the treatment of previously treated MM     has provided effective therapeutic options that give patients with relapsed or refractory MM     the prospect for a prolongation of overall and progression-free survival times. However, MM     remains an incurable disease. A clear unmet medical need still exists for additional novel     therapeutic options for the treatment of previously treated MM.      Plerixafor reversibly inhibits CXCR4 binding to stromal cell derived factor (SDF)-1alpha and     was recently discovered to be an effective agent to mobilize CD34+ cells into the peripheral     blood. In normal volunteers, administering Plerixafor after 4-5 days of G-CSF resulted in a     3-3.5 fold increase in circulating CD34+ cells. Two phases 3 studies demonstrated that the     combination of G-CSF and Plerixafor is superior to G-CSF alone for mobilizing hematopoietic     progenitor cells in front-line or as salvage therapy in patients with multiple myeloma.      Nevertheless, almost all patients ultimately relapse, and no plateau is observed in the     survival curves. At the time of disease recurrence, there is not one standard salvage     approach, but instead, various therapeutic options are available, including novel     agents-based therapy, administered for a fixed duration of time or until progression. In the     pivotal trial for the approval of bortezomib as monotherapy in relapsed and refractory MM,     the median PFS was 7 months, whereas in the pivotal trials for the approval of lenalidomide     in combination with dexamethasone in the same group of patients, the median time to     progression was approximately 11 months. A more recent prospective, randomized, phase 3 study     has shown that a triplet combination of bortezomib, thalidomide and dexamethasone (VTD)     achieved superior results compared to thalidomide dexamethasone (TD) alone in patients     relapsing following ASCT, with a median time to progression of 19.5 versus 13.8 months,     respectively. This study suggests that combinations consisting of both an IMiD and a     proteasome inhibitor are a valuable option at the time of relapse.      However, when a frozen graft is available, it is also possible to repeat high-dose therapy in     patients who previously responded to the frontline application of high-dose melphalan and     ASCT. Over time, several reports have demonstrated the feasibility of this salvage strategy.     The majority of data are available from retrospective studies and are based on single-centre     experiences with small numbers of selected patients. In this setting, PFS has been shown to     range from 7 to 22 months, and the treatment-related mortality (TRM) was acceptable, ranging     from 0 to 8%. Various prognostic factors for prolonged PFS have been described, such as the     duration of response to the first high-dose therapy, or the number of lines of therapy prior     to salvage ASCT.      With this background, this prospective non-interventional multicentre study will aim to     collect data on the feasibility of salvage ASCT using a Plerixafor-based stem cell     mobilization in relapsed MM, according to Plerixafor label in France.      This is a non-interventional study; visit will be performed as usual, according to each     center practices. No additional visits will be requested for the study purpose. The date for     each visit and any data generated must be recorded on the appropriate eCRF.      The study will consist of 3 periods:        -  An early screening period        -  Autologous stem cell mobilization period        -  High dose melphalan therapy and autologous graft infusion and follow-up for12 months          after salvage ASCT Inclusion visit      This visit may occur up to 28 days before Mozobil® administration. This visit will be     performed during the visit of pre-transplant assessment. For the pre-transplant assessment,     the procedures are performed routinely before ASCT even if the patient is not included in the     study:      Stem cell mobilization phase The stem cell mobilization phase is performed according to     standard practice of each participating centre.      Follow-up visits High dose melphalan administration and autologous graft infusion will be     performed according to each centre standard practice. Patients will be followed according to     each center practices. The follow-up of this non-interventional study will end 12 months     after ASCT.      Subjects will be enrolled over a 2 years period. The total duration of the study will be 36     months   "
64649|NCT02439463|"     The present study assesses the health-related quality of life and the locomotor capabilities     major traumatic lower limb amputees who use prosthesis.   "
64652|NCT02439424|"     Recent advancements with implantable cardiac device technology include extensive diagnostic     and therapeutic algorithms for prevention as well as termination of atrial tachyarrhythmias     (ATA). Preventive atrial pacing (PAP) and a novel atrial antitachycardia pacing algorithm     (Reactive ATP™) in conjunction with managed ventricular pacing (MVP) recently has been shown     to reduce progression to permanent atrial fibrillation (AF) in pacemaker patients with intact     atriovenous (AV) conduction and a history of ATA. Whether the use of Reactive ATP™ for     reducing AF burden extends to patients with an implantable cardioverter defibrillator (ICD),     who typically have structural heart disease and heart hailure (HF), is unknown.   "
64659|NCT02439333|"     The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive     pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas     analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2＞45mmHg) or have achieved the traditional     noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter,     venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen     concentration methods with inadequate heating and humidifying lead to poor patient tolerance     and adverse reactions such as airway secretions discharge disorders. The high flow nasal     respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional     low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of     up to 60 litres per minute via nasal cannulas with low level continous positive airway     pressure. This study is a prospective randomized study. AECOPD patients with no severe     respiratory failure are treated with NHF and conventional oxygen therapy respectively. The     target is that NHF can increase the comfort degree of patients,reduce the rate of     endotracheal intubation, and shorten the time of hospitalization.   "
64660|NCT02439320|"     This is a prospective randomized, double-blind, placebo-controlled study in subjects with     disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).   "
64661|NCT02439307|"     A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be     evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal     hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE     with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth     (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of     rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional     assessment, biochemical studies, and evaluation of quality of life will be performed in all     patients included in the study. Besides the initial visit, patients will receive subsequent     care 2, 4, 8, 12, and 24 weeks after the beginning of the study.   "
64662|NCT02439294|"     Coronary artery disease is a common and serious disease, the leading cause of death     worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in     coronary artery disease where it could be involved in the pathophysiology and perhaps     prognosis. The entanglement of the two pathologies is actually quite well known, in     particular the consequences of one over the other just beginning to be studied. Understanding     the pathophysiology through new imaging modalities should improve the management of patients     to propose new approaches.      SAS-IDM is an interventional and prospective study conducted at the University Hospital of     Montpellier. Patients will be divided in three groups depending of the results of the     polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate     OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the     group severe OSA.   "
64663|NCT02439281|"     Background: Millions of pediatric patients undergo laparoscopic surgeries every year and many     of them suffer significant pain and anxiety. Patient's anxiety correlates with the severity     of pain and effective postoperative analgesia is necessary for optimal recovery. Single     injections ultrasound guided rectus sheath blocks provide satisfactory postoperative     analgesia after pediatric laparoscopic appendectomy, however they are short lived. Searching     for a blocking agent that last long enough to outlast pain and has minimal side effects is a     difficult task. Using a combination of drugs yielded mixed results. Few pediatric studies     showed at best a weak trend in favor of clonidine prolonging analgesia after some blocks, but     anxiolytic properties of clonidine were not investigated. This study will compare rectus     sheath ropivacaine blocks with ropivacaine and clonidine blocks.      Methods: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic     appendectomy will be double blinded and randomized to the two treatment groups: the     Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior     rectus sheath, at the umbilicus location, and Ropivacaine Clonidine Group will receive     ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg). Post-operative analgesia will be provided     with ketorolac and acetaminophen around the clock, and morphine, or/and oxycodone as needed.     The primary aim is to determine if ropivacaine combined with clonidine prolongs duration of     paresthesia. The secondary aims are to determine if the use of clonidine decreases anxiety     level, prolongs duration of analgesia, and decreases pain severity at umbilicus laparoscopic     site, reduces the need for analgesics, improves satisfaction with pain control, and is     associated with complications such as oversedation, hypotension, and bradycardia.      Conclusions: Every hour of excellent analgesia count and a prolongation of block duration by     at least 50% is clinical relevant. The investigators hypothesize that rectus sheath     injections with ropivacaine and clonidine offer improved pain management compared to     ropivacaine alone.   "
64664|NCT02439255|"     This randomized clinical trial studies the effects of black raspberry compounds     (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and     non-smokers. The oral microbiome protects the body from pathogenic bacteria. Smoking alters     the oral microbiome and may increase the susceptibility to cancer by modulating normal     host-bacteria interactions. Black raspberry phytochemicals may protect the oral microbiome of     smokers and may lower their risk of developing oral cancer.   "
66171|NCT02419573|"     The primary objective of the trial is to determine if 72-hour survival after out-of-hospital     cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial     laryngeal tube (LT) airway management strategies.   "
64665|NCT02439242|"     In high perioperative risk patients, guidelines suggest intraoperative haemodynamic     optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy     requires an invasive monitoring and learning. Some studies tried to find SV surrogates based     on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to     the pulse pressure (PP) / heart rate (HR) ratio.      The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR     ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a     ΔSV greater than 10%.   "
64666|NCT02439229|"     The Vitamin D and fetal bone length study:      Vitamin D and its association to bone length in midterm pregnancy.   "
64667|NCT02439216|"     The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy,     pharmacokinetics (PK) and pharmacodynamics (PD) of edasalonexent (also known as CAT-1004) in     pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from ≥4 to <8     years of age will be enrolled.      Edasalonexent is an orally administered small molecule targeted to inhibit activated NF-κB, a     molecule that is activated from infancy in DMD and which is central to causing muscle damage     and preventing muscle regeneration. Data on magnetic resonance imaging of the lower and upper     leg muscles, physical function (including timed function tests) and muscle strength will be     studied.   "
64668|NCT02439203|"     The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to     evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment     of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).   "
64669|NCT02439190|"     The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and     clopidogrel decrease blood clotting.   "
64670|NCT02439177|"     The aim of this study is to determine the System Accuracy and User Performance evaluation of     the mentioned BGM systems by gaining a sufficient amount of measured data from capillary     blood.   "
64671|NCT02439164|"     Sedation in the operating room, the Post Anesthesia Care Unit and the Intensive Care Unit is     common and often necessary for patients with intracranial brain tumor. Repeated neurological     function assessments is needed in those locations, especially in patients with tumors in or     near eloquent regions, this is to monitor their neurologic performance to determine if there     are alterations that require treatment. Some slowly infiltrative low-grade gliomas near     eloquent regions do not show any detectable neurologic deficits, perhaps from reorganization,     but with sedation by some sedatives such as benzodiazepine midazolam and anesthetic hypnotic     propofol, the disease may seem much worse resulting in inappropriately aggressive treatment.     This may be especially problematic in patients undergoing awake craniotomy for tumors in     eloquent regions.      This is a single-center perspective study. Patients will be mildly sedated to keep them     responsive and cooperative. Motor and sensory function will be evaluated before and after     mild sedation. Specific benzodiazepine antagonist will be used if sedated by midazolam.      The purpose of this study is to observe if commonly used benzodiazepine midazolam exacerbates     or unmasks motor and sensory function in patients with intracranial eloquent area gliomas.      Hypothesis:      mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent     area glioma but not in non-neurosurgical patients/healthy volunteers. If the neurologic     deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.   "
64672|NCT02439151|"     Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe acute     respiratory distress syndrome (ARDS). But how to choose mechanical ventilation strategy is     still not clear for severe ARDS patients supported by ECMO. Our previous work found that,     compared to the traditional lung rest strategy, transpulmonary pressure guide new lung     ventilation strategy can better maintain lung volume reduction lung collapse, atelectasis     occurs. The severe ARDS patients receiving ECMO therapy were randomized divided into a new     ventilation strategy group and the conventional ventilation strategy group. The new     ventilation strategy is transpulmonary pressure guide ventilator setting method, and the     conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide     ventilation method. Compare the difference between the two groups of patients in lung injury,     and explore the lung protection mechanism of new lung ventilation strategies guided by     transpulmonary pressure. Our research group considered that transpulmonary pressure guide new     lung ventilation strategy can provide more effective lung protection. And it will be further     used in clinical work.   "
64673|NCT02439138|"     This research study is evaluating a drug called idelalisib (formerly known as GS-1101 or     CAL-101) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).   "
64674|NCT02439125|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine     to treat levodopa-induced dyskinesia in patients with Parkinson's disease   "
64675|NCT02439112|"     The overall aim is to examine whether early initiated, individualized exercise training in     patients newly diagnosed with multiple myeloma, irrespective of age and current performance     status, will be beneficial for the patients´physical function, level of physical activity and     quality of life, pain and bone disease.      The investigators will examine the effect of supervised in-hospital exercise training     sessions combined with home-based exercise training, initiated at time of diagnosis. The     outcomes of interest are physical function, level of physical activity, QOL, pain and bone     disease.      Furthermore, to describe the disease in patients with newly diagnosed MM in relation to     physical function, level of physical activity, QOL, pain and bone condition at time of     diagnosis.      The investigators hypotheses are:        -  Individualized exercise starting at time of diagnosis will have positive effects on          physical function, physical activity, QOL and pain.        -  Individualized exercise starting at time of diagnosis will have positive effects on bone          disease (bone markers), bone mineral density (BMD) and lean body mass.        -  A higher level of physical function is associated with a higher level of physical          activity, less pain, better QOL, and higher BMD and lean body mass.   "
64676|NCT02439099|"     It is hypothesized, that local retinoic acid (RA) homeostasis is functionally involved in the     pathophysiology of depression. In a cross-sectional (and partly longitudinal) analysis, serum     RA status will be assessed in healthy controls and subjects with Major Depression,     Alzheimer's disease, alcoholism and in subjects with schizophrenia.   "
64678|NCT02439073|"     Purpose The purpose of the PROLUCA study is to investigate the efficacy of early     postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer,     with focus on exercise training.      Design/Methods      One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell     Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the     following two groups:        1. Early postoperative rehabilitation initiated as early as two weeks after surgery        2. Postoperative rehabilitation initiated 14 weeks after surgery Intervention The          intervention consists of a supervised group exercise program comprising resistance and          cardiorespiratory exercise two hours weekly for 12 weeks combined with individual          counseling.      The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct     measurement) Secondary endpoints include: Six minutes walk distance (6MWD),     One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of     life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick     leave, work status and survival.      Results The results of PROLUCA will identify the optimal timing of postoperative     rehabilitation in NSCLC patients with focus on increasing physical capacity and health     related quality of life and reducing the side effects from the treatment of the cancer     disease.   "
64679|NCT02439060|"     This randomized phase III trial studies how well biologic mesh works in preventing parastomal     hernia in patients with bladder cancer who are undergoing radical cystectomy, or removal of     the bladder, and ileal conduit diversion. An ileal conduit is a tube created from your small     intestine that will be used as a tube for urine to flow out of your body. Parastomal hernia     is a type of hernia that can occur in the stomach area where the ileal conduit is placed.     Biologic mesh may help prevent parastomal hernia following surgery and ileal conduit     diversion.   "
64682|NCT02439021|"     The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be     highly safe for adult and pediatric patients. However, the LMA has some limitations and     weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy     insertion of the LMA, it is crucial to check correct placement of the LMA airway.   "
64684|NCT02438995|"     This is an open-label, non-randomized, two arm, Phase I research study of superselective     intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of     recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).   "
64685|NCT02438982|"     Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of     these patients respond well to corticosteroids. However, as many as 70% of children with     nephrotic syndrome experience at least one relapse, and 30% develop a more complicated course     with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid dependency     (SDNS)(relapse during tapering or within 2 weeks after discontinuation of corticosteroids).     Repeated and prolonged courses of steroids in these children often result in long-term     complications. The goal of the treatment is to reduce the rate of relapses, the cumulative     dose of corticosteroids, and the incidence of serious complications. In order to minimize the     side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide,     calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in     SDNS. Whereas CNI are usually considered the steroid sparing drug class of first choice,     rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective     studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and     effective alternative to steroid or immunosuppressants to achieve and maintain remission in     this population.Single rituximab course have been shown to be efficacious for 6 to 12 months     and the side effect profile observed to date is very benign. Studies comparing the usefulness     of these agents are lacking. In our proposed randomized controlled trial, the investigators     want to compare the efficacy and safety of CNI to that of Rituximab in treating children with     SDNS.   "
64686|NCT02438969|"     Background:      - Researchers want to learn if people with alcohol dependence have more difficulty learning     to feel calm, or learn to fear things more easily. They also want to study how early life     stress (ELS) affects the ability to learn to feel calm.      Objective:      - To see if people with alcohol dependence and/or ELS have a harder time learning to feel     calm than people without these. Also, to see if DNA is changed by ELS and if this change     affects fear conditioning and extinction.      Eligibility:        -  Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without          ELS.        -  Healthy volunteers.      Design:        -  Participants will be screened with:             -  Medical history             -  Physical exam             -  Blood and urine tests             -  Psychological tests             -  Treatment for symptoms of alcohol withdrawal, if needed        -  Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will          stay at the clinic for about 4 weeks.        -  Participants will:             -  Rate alcohol use/craving, depression, anxiety, and childhood trauma.             -  Have psychophysiological measures: electrodes and mild electric shock.        -  Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a          table in a metal cylinder with a coil over their head. In the first scanning session,          they will see pictures, do a simple task, and may get shocks. Participants will also do          a second scanning session in which they will perform the aforementioned fear          conditioning and extinction task, as well as a facial expression matching task, an          affective word processing task, and a task measuring valuation of monetary rewards.             -  Answer questions about their emotions (some participants).             -  Have blood drawn from an arm vein or intravenous (IV) line.             -  AUD participants will get a dexamethasone pill. The next day, they will get a               hormone injected in and have blood drawn from an IV line.        -  AUD participants will have 3 follow-up visits with questions and blood and lab tests.   "
64687|NCT02438956|"     A randomized, double blind placebo-controlled parallel intervention in adults over the age of     50 will be performed. Participants will receive a supplement capsule containing placebo     (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is     hypothesized to replenish the body's reserves that may be depleted through natural aging     process, poor diet, or due to the detoxification process for drugs. The primary end point is     the number of healthy days experienced during the duration of the study. Secondary endpoints     include cellular and biochemical measures from blood samples taken before and after the     study.   "
64688|NCT02438943|"     To assess the effectiveness of a clinical audit and physician based intervention in improving     the management of dyslipidemia at Health centres in the Southeast Health Region of Jamaica   "
64689|NCT02438930|"     This study pilot tests and intervention to help individuals reduce their risk for acquiring     or transmitting HIV. The intervention is implemented when people are tested for HIV in an     outpatient clinic in rural Uganda. Approximately half of participants will receive the     intervention and the other half will receive the usual counseling provided during HIV     counseling and testing.   "
65046|NCT02434276|"     This is a multi-center, randomized, double-blind, active comparator controlled study in which     up to 450 healthy adults age 18-64 years will be administered either one of two dose levels     of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at     a 1:1:1 ratio.   "
64690|NCT02438917|"     Chronic liver injury leads to the accumulation of proteins in the liver that form dense     scars. Liver scar formation is typically a slow process that leads to major organ damage and     loss of function over the course of many years. During scar formation the extracellular     matrix in the liver changes. The type and quantity of extracellular collagen and other     proteins change during tissue remodeling. Some of these changes can be detected by analyzing     factors present in blood. Because of the lengthy time course, changes in the rate of liver     scar formation and regression are very difficult measure; however, accurate measurements are     needed in order to conduct trials of interventions aimed at preventing scar formation and/or     promotion scar regression. Current methods have sub-optimal specificity and selectivity. The     long term objective of the study is to identify serum proteins that can be used to accurately     estimate rates of liver fibrosis progression and regression. The project focusses on a novel     methodology that uses stable isotope labeling with deuterated water, D2O, to tag     newly-synthesized proteins. Mass spectroscopy is used to identify individual proteins and to     quantify the ratio of labeled protein to total protein. This ratio provides information about     the rate of synthesis of the protein of interest. This method will be applied to specimens     from patients with hepatitis C virus (HCV) infection who are about to begin HCV treatment.     Treatment is known to reduce liver inflammation and collagen content.   "
64691|NCT02438904|"     Objectives:      Primary Objective      To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients     who experience poor graft function after stem cell transplantation (SCT).   "
66244|NCT02418598|"     The purpose of this study is to evaluate the safety, efficacy of intra-putaminal infusion of     AAV-hAADC-2 (adeno-associated virus encoding human aromatic L-amino acid decarboxylase) by     stereotaxic surgery in patients with advanced Parkinson's disease.   "
64692|NCT02438891|"     Most tinnitus sufferers experiences significant anxiety or depression that worsens the     subjective symptoms related to tinnitus. In this study, we intend to use internet-based     cognitive behavioral therapy (CBT) in addition to sound therapy to provide psychotherapy to     patients with tinnitus. Multiple research studies have found CBT to be effective in improving     the subjective symptoms of tinnitus. The internet-based CBT course developed for this study     is 8 weeks in duration and organized into eight 1-week modules; each module contains 2-4     separate lessons and homework assignments. Patients will be given unique usernames and     passwords. In each weekly module, patients will review educational materials online, do     exercises. and will be given feedback based on the results of the completed exercises. In     addition, patients are given different meditation exercises each week for relaxation and     coping with their tinnitus. These interactive materials enable patients to manage and control     any negative feelings and thoughts that may be associated with tinnitus and help take their     attention away from tinnitus. Tinnitus loudness and annoyance will be measured before and     after the program. An internet-based course enables care providers to monitor patients'     progress with the CBT course remotely, and allows patients to learn CBT at their own     convenience and schedule.   "
64693|NCT02438878|"     The primary objective of this project is to evaluate the impact on infant growth and     infant-feeding practices of a low-cost series of video trainings and tools targeted to     medical staff and designed to support ongoing Baby Behavior education of WIC participants.   "
64694|NCT02438865|"     This clinical trial is designed to compare the effect of single postoperative intravesical     chemotherapy instillation versus maintenance therapy on reducing bladder cancer recurrence     after surgery for UTUC.   "
64695|NCT02438852|"     This randomized phase IV trial studies how well the continuous infusion of ropivacaine     hydrochloride works in reducing pain after surgery in patients with bladder cancer.     Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of     the body without putting the patient to sleep. Continuous infusion of ropivacaine     hydrochloride may reduce pain and improve the quality of life for patients after bladder     surgery.   "
64696|NCT02438839|"     The aim of the present study is to investigate whether curative chemoradiation of low rectal     cancer is feasible, safe and effective in a multicenter study with results comparable to     those of single center studies.      Results from previous studies indicate that a considerable fraction of patients with low     rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be     spared from operation.   "
64697|NCT02438826|"     The main purpose of this study is to evaluate the efficacy of the study drug known as     LY2951742 in participants with chronic cluster headache.   "
64698|NCT02438813|"     The primary objective of this registry is to develop a comprehensive understanding of the     condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current     clinical practice, and the risks and benefits associated with its treatment.   "
64699|NCT02438800|"     This is a randomized clinical trial to evaluate if the addition of long-acting reversible     contraception (LARC) focused video-counseling during prenatal care increases uptake of     postpartum LARC.   "
64700|NCT02438787|"     The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha)     refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured     by the reduction in signs and symptoms of radiographic AxSpA.   "
64701|NCT02438774|"     It has been shown that exposure to mycotoxins through complementary foods and breast milk had     profound effects on growth of children from 6 months to 1 year of age. In Tanzania maize is     the main ingredient for complementary food, however, the crop is vulnerable to mycotoxins     contamination. it has been reported that the most effective way to reduce mycotoxin exposure     is to lower the mycotoxins contamination of maize. This study has developed a post-harvest     intervention package for use in rural Tanzania to reduce contamination of maize and breast     milk with two forms of mycotoxins; aflatoxins and fumonisins. It is composed of 5 components;     1) hand sorting, 2) drying surface, 3) proper drying 4) application of insecticide, 5)     dehulling and was introduced in three main maize producing agro-ecological zones. The     intervention used randomised controlled trial design where infants less than 8 six months of     age were recruited and followed up 6 months after recruitment. The intervention expects to     demonstrate the effectiveness of the post harvest intervention package in reducing aflatoxins     and fumonisins contamination of maize and subsequent exposure of these toxins to infants and     young children through maize based complementary food and breast milk. The findings will be     used in developing guidelines for farmers and extension officers to reduce aflatoxins and     fumonisins contamination of maize and improve the health of the infants and the whole     population.      The study hypothiseses that introducing post-harvest intervention package can reduce     aflatoxins and fumonisins contamination of maize and subsquent exposure of these toxins to     infants and young children through maize based complementary foods and breast milk than     routine agriculture extension services offered to the farmers in rural Tanzania. The specific     objectives include;        -  To evaluate the effectiveness of post-harvest intervention package on reduction of          aflatoxins and fumonisins contamination of maize and in breast milk        -  To perform exposure assessment of aflatoxins and fumonisins to infants and young          children through maize based complementary food and breast milk        -  To perform risk characterization of aflatoxins and fumonisins exposure to infants and          young children through maize based complementary foods and breast milk        -  To assess the association between exposure to aflatoxins and fumonisins and child growth   "
64702|NCT02438761|"     Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384     (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.   "
64703|NCT02438748|"     The main objective of this study is to determine whether biological stress markers (Oxidized     Phosphatidylcholines) in the blood can be used to predict the efficacy of rTMS in the     treatment of major depressive disorder (MDD). It is our goal to identify biomarkers that may     be used to determine which patients will benefit from rTMS treatment. A second objective of     this study is to measure any changes in stress markers that occur across the course of rTMS     therapy.   "
64704|NCT02438735|"     Purpose of this study is to determine if the presence of endometriomas cause a reduction in     ovarian reserve. Endometriosis and fertility problems experience are frequent. There seems to     be an association between endometriosis and subfertility. This study aims to asses if the     endometrioma it self causes diminished ovarian reserve after a certain time period, with     determination of ovarian reserve with anti-mullerian hormone (AMH), follicle stimulating     hormone (FSH),luteinizing hormone (LH), estradiol and antral follicle count (AFC) values.   "
64705|NCT02438722|"     This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works     and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage     IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive     non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may     block tumor growth in different ways by targeting certain cells. It is not yet known whether     afatinib dimaleate is more effective when given alone or with cetuximab in treating patients     with non-small cell lung cancer.   "
64706|NCT02438709|"     The purpose of this study is to determine whether COX-2 inhibitor is effective in the     treatment of primary hypertrophic osteoarthropathy   "
64708|NCT02438683|"     This trial will be conducted to further evaluate, in a controlled setting, potential cardiac     effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting     and exercise conditions. Since the drug is being developed in part for a disease with an     expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306     is considered to be important for the development of this compound.      This trial will be conducted to further evaluate, in a controlled setting, potential cardiac     effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting     and exercise conditions.      Since the drug is being developed in part for a disease with an expectedly high number of     elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be     important for the development of this compound.   "
64709|NCT02438670|"     The goal of this proposed study is to compare use of a PID (Proportional-Integral-Derivative)     controller versus an MPC (Model Predictive Control) controller algorithm in an artificial     pancreas system, all other components and study design being equal. The study design, power     calculation and endpoints were developed based on the results of an initial feasibility study     (ClinicalTrials.gov Identifier: NCT01987206) that has already been completed.   "
64710|NCT02438657|"     Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral     nerve block.      The aim of the study is to determine the minimum volume of local anesthetic to achieve an     ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.   "
64711|NCT02438644|"     This observational, noninterventional study is designed to further characterize the     effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only     patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell     carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is     estimated to be approximately 12 months.   "
64712|NCT02438631|"     The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK)     models to put the generated data into context with medical conditions that require maternal     or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life'     maternal and fetal PK data, such as data from the PANNA network.      Ultimately, these PBPK models of drug therapy during pregnancy will provide a powerful tool     to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based     research in pregnant women in the future, and 3.) guide future development of new molecular     entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and     potentially toxic effects in utero).   "
64714|NCT02438605|"     The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at     prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional     CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and     post-operative will be assessed for device changes and anatomical variances.   "
64715|NCT02438592|"     This is an observational study involving retrospective and prospective medical record review     covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted     Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of     study subjects. Data will also be collected to assess clinic level variables. Definitions of     engagement, prescription of antiretroviral therapy (ART), and viral suppression in the     Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of     Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA)     HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to     provide all elements for both the primary and secondary outcomes.   "
64726|NCT02438449|"     It is estimated that about 25% and 40% of health care expenditures in Canada and USA     respectively are wasted because of inefficiencies and not practicing evidence-based medicine.     As health care resources are scarce it behooves all of us to use these in a cost-effective     manner. The term cost-effective is used in the health care literature often but     erroneously. Investigators compare a novel' intervention to a prevailing one and if the     novel intervention is less costly it is labeled cost-effective. In a methodologically     correct cost-effectiveness study however, investigators need to integrate both the     effectiveness and costs of the competing interventions and calculate an incremental     cost-effective ratio. If this ratio falls within acceptability thresholds, the novel     intervention is labeled cost-effective. There are many techniques of breast reconstruction.     The two most common approaches are the Autologous Abdominal Tissue (AAT) and the Tissue     Expansion / Implant reconstructions. In this study these two most common breast     reconstruction approaches after mastectomy due to cancer performed in the     Hamilton/Niagara/Haldimand/Brant and Waterloo/Wellington LHINs will be investigated with a     cost-effectiveness analysis coupled with a methodologically robust observational study.   "
64716|NCT02438579|"     Viral upper respiratory tract infections (URTI), one of the commonest infection faced by     humans, have a significant impact on individuals, families, health service and economy.     Though rhinoviruses are called the common cold virus, numerous viruses can cause URTI.     Hence virus specific remedy for URTI is impractical. There are currently no evidence-based     interventions that reduce the severity, symptom duration or viral shedding. Preliminary     evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce the     duration of symptoms.      With this pilot randomised controlled trial (RCT), the investigators aim to assess the     feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses     on recruitment rate, willingness to be randomised, acceptability, compliance and likely     effect size of the intervention.      This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected     mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is measured     by a validated symptom score. A questionnaire based participant feedback will help assess     intervention and trial procedures.      This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost     intervention that has the potential of substantial health and societal benefits.   "
64717|NCT02438566|"     The purpose of this research is to determine if the oral form of a medication (tranexamic     acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best     way to give tranexamic acid: either a pill by mouth, or a solution by vein.   "
64718|NCT02438553|"     The purpose of this study is to evaluate the short-term effectiveness of combined occipital     and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.   "
64719|NCT02438540|"     The investigators designed this randomized double blind (patients/ assessor) clinical trial     to compare the therapeutic effects of Metformin monotherapy with Metformin and acupuncture     combined therapy on weight loss and insulin sensitivity among overweight/obese type 2     diabetes mellitus (T2DM) patients. We compared the inflammatory markers, lipid profiles, and     adipokines in overweight/obese T2DM patients receiving the combined therapy to those     receiving the Metformin monotherapy, to understand whether acupuncture plus Metformin is a     better approach then Metformin only on treating diabetes.   "
64732|NCT02438371|"     Tocolytic agents are used for the treatment of preterm labor. It is unclear whether     combination treatments of two tocolytic agents are more effective in stopping preterm labor     compared to one. Therefore, the investigators propose a comparative effective trial of     nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor   "
64720|NCT02438527|"     ABSTRACT      Background:      More than two thirds of sudden cardiac arrests are witnessed by bystanders. Bystander     cardiopulmonary resuscitation (CPR) doubles survival from cardiac arrest. Importantly, even     in witnessed cardiac arrests only 20% of the bystanders commence basic life support. Common     reasons for not commencing include panicking and the perceived inability to perform CPR     correctly. A meta-analysis could demonstrate that a simplification of the algorithm     (compression-only dispatcher-assisted bystander CPR) led to a 22% increase in     survival-to-hospital discharge. A recently published trial of the research group could     demonstrate that the presence of a flowchart has a positive effect on the quality of BLS     while at the same time increasing the rescuers' confidence. Nonetheless, performing CPR is     exhausting. Previous publications have emphasized increasing fatigue with the duration of CPR     efforts in both, standard and chest compressions-only CPR. Consequently, we wanted to test     the hypothesis that chest compressions (CC) are delivered more correctly regarding the depth     when utilizing the standard BLS algorithm with the aid of a flowchart as compared to the CC     only algorithm utilizing an adapted CPR flowchart in a manikin resuscitation model.      Methods:      After consent of the Research Ethics Board of Medical University of Vienna and obtaining     written informed consent of the participants, 84 medically untrained laypersons will be     randomised to perform flow-chart assisted CPR for 300s following standard CPR guidelines or     CC only CPR. The primary outcome parameter will be the total number of CC achieving the     correct depth of 50-60mm. Secondary outcome parameters will be hands-off time, the total     number of CC, and the compression rate. The total number of delivered rescue breaths, tidal     volume, and time to deliver these will also be evaluated. Furthermore, the subjective point     of exhaustion affecting the CPR quality, the reason for discontinuation of CPR if stopped     within the 300sec. period and the exhaustion at the end of the CPR measures will be     evaluated.   "
64721|NCT02438514|"     The investigators propose to evaluate the potential utility of stress-related biomarkers     obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers     and children within the New Haven MOMS Partnership, a well-established community-partnered     research setting. The proposed research could greatly advance the application of     stress-related biomarkers within community-based research by increasing our understanding of     how stress, trauma, and depression influence biology in childhood and adulthood, as measured     using minimally-invasive approaches.   "
64722|NCT02438501|"     Many trials that patients with advanced or recurrent indolent lymphoma managed with very     low-dose (4Gy) limited-field RT (LD-IFRT) have shown that high response rates and durable     remission can be achieved. However, the results of two phase III trials have failed to     demonstrate the lasting response rate (RR) with LD-IFRT versus in other approaches.     Histology, bulky tumor (>5 cm), higher number of prior chemotherapy regimens, adoption of     rituximab, and age＞65 years have been shown to significantly influence response rates of     LD-IFRT. The objectives of this trial investigate the efficacy of palliative low-dose     involved-field radiation therapy in patients lower than 65 years of age with recurrent     advanced follicular lymphoma.   "
64723|NCT02438488|"     Vitamin D deficiency is a risk factor for mortality but existing data are limited by missing     standardization of laboratory methods for 25-hydroxyvitamin D (25[OH]D). In a European     consortium of eight cohort studies we use protocols of the Vitamin D Standardization Program     (VDSP) to obtain standardized 25(OH)D data. Individual participant data (IPD) meta-analyses     using a one step procedure will be performed to study associations of original and     standardized 25(OH)D with all-cause, cardiovascular, and cancer mortality.   "
64724|NCT02438475|"     Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure     following both diagnostic and interventional procedures as assessed by clinical and imaging     criteria.   "
64725|NCT02438462|"     The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing     Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the     Soluble Fibrin Assay and the D-Dimer test.   "
64754|NCT02438085|"     The ARYOSTO has been designed to describe the clinical epidemiology and the current     management of acute coronary syndromes (ACS) in the area of Ferrara. Especially, the Authors     will evaluate the medical and interventional management of ACS patients admitted to hospitals     in the area of Ferrara and receiving coronary artery angiography and percutaneous coronary     intervention (PCI) in the hub center of Ferrara (Azienda Ospedaliera Universitaria di     Ferrara, Cona (FE), Italy)   "
64727|NCT02438436|"     Abdominal surgery, including hepatic resection for hepatocellular carcinoma (HCC), is     inevitably followed by an episode of gastrointestinal hypomotility. A delayed return of     gastrointestinal function, defined as postoperative ileus (POI), has a great impact on     patient comfort, morbidity and recovery. POI often results in a prolonged hospital stay and     contributes significantly to healthcare costs.      Some prospective studies have revealed that gum chewing can improve the return of     gastrointestinal function after colorectum surgery, gynaecology and obstetrics, and urinary     system surgery. Moreover, some retrospective studies also revealed that simo decoction may     improve the return of gastrointestinal function after hepatic resection of HCC. Therefore,     the present study compared the effect of gum chewing and simo decoction after hepatic     resection of HCC on POI, surgical complications, and length of hospital stay.   "
64728|NCT02438423|"     Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of     Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.      This is a single center, partially blinded, randomized phase I study in which healthy adult     subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by     microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is     designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an     inactivated influenza vaccine delivered by microneedle patch.   "
64729|NCT02438410|"     To assess if infliximab drug levels in subjects with Ulcerative Colitis predict risk of     colectomy rate. Additionally, the investigators will estimate an optimal day 4 infliximab     level based on the study results.   "
64730|NCT02438397|"     the study objective: to explore the efficacy of acarbose and metformin on glucose     fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with     premix insulin.   "
64733|NCT02438358|"     For most breast cancer patients, surgery is the primary treatment. When patients undergo a     lumpectomy, it is difficult for the surgeon to determine the extent of the tumor which     results in incomplete tumor removal as determined by a positive margin assessment several     days after the initial surgery is completed. Most patients with positive margins will undergo     a second or even a third surgery to complete the tumor removal. The investigators hypothesize     that the LUM Imaging System can reduce the rates of positive margins and, thus, the rates of     second surgeries by identifying microscopic residual cancer in the tumor bed.      This is a non-randomized, open label study to evaluate the safety and efficacy of an     intraoperative imaging system, the LUM Imaging System (LUM015 in conjunction with LUM 2.6     Imaging Device), in identifying residual cancer in the tumor bed of female breast cancer     subjects. The study is composed of a Feasibility Trial divided into two phases: Phase A (15     total subjects) and Phase B (up to 50 total subjects). During Phase A, 15 subjects will be     evaluated to collect additional patient safety data, select the dose of LUM015 for Phase B     and evaluate the device function. During Phase B, subjects will be injected with LUM015 at     the dose determined during Phase A to preliminarily assess the performance of the detection     algorithm against pathology margin assessment. In Phase B, the surgeon will perform standard     of care surgery and then use the LUM Imaging System to guide the removal of additional cavity     shavings as indicated by the LUM Imaging System.   "
64734|NCT02438345|"     PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial     of observed systemic, long-acting, anti-HIV treatment with a monoclonal CCR5 antibody (PRO     140) as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection     drug users with viral rebound and documented poor adherence to the previous antiretroviral     regimen. Eligible subjects (approximately 76) will be randomized 1:1 to receive an optimized     background antiretroviral regimen (OBR) plus supervised weekly subcutaneous treatment with     either PRO 140 or placebo. Blood samples for safety and efficacy variables will be obtained     over the 24 week duration of the study. Safety will be monitored throughout the course of the     study.   "
64735|NCT02438332|"     This study will evaluate the incidence of reoperations associated with the use of smooth and     textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone     primary breast augmentation.   "
64736|NCT02438319|"     Manually and automatically by mashing learning algorithm optic disc will be evaluated     (planimetry).   "
64737|NCT02438306|"     This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control),     sham-controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP     cell therapy to a sham treatment.      A roll-in phase with a maximum of 10 subjects will precede the randomised phase.   "
64738|NCT02438293|"     This is a prospective single- center observational study in the Leiden University Medical     Center in approximately 250 children (<12 years) undergoing elective cardiac surgery, for     congenital heart disease. The parents/guardians of the children will be asked to fill out a     questionnaire, to asses respiratory symptoms in the last weeks, before the operation of their     child. In the operating theatre, a nasopharyngeal swab will collected. Clinical data will be     collected daily during paediatric intensive care admission, and date of discharge from     paediatric intensive care unit and from hospital are recorded. If children are still     intubated at day 4 a second nasopharyngeal swab and residual blood will be collected. The     samples will be tested for rhinovirus with a polymerase chain reaction. Main study parameter     is the paediatric intensive care unit length of stay in per-operative rhinovirus -positive     compared to rhinovirus-negative patients.   "
64739|NCT02438280|"     The AcceleDent® device has been introduced to the specialty of orthodontics in order to     reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces     (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth     movement to occur more quickly.      Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort     during orthodontic treatment.      This study will be a parallel group, triple-blind randomized clinical trial comparing two     groups of subjects with 12 participants in each group. Subjects will be randomized to receive     one of two vibrational units, which will differ in frequency and/or amplitude of vibration.     The subjects will be asked to change their aligners every week instead of every 2 weeks,     which is common with Invisalign.   "
65047|NCT02434263|"     The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra     Aortic valve in real-world patients. Following initial implantation, all patients will have     clinical follow up at 30 days, 3, months, 6 months and 12 months   "
64740|NCT02438267|"     Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur     in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born     prematurely and with very low birth weight (<1500 gm) seem to be at the highest risk of     developing NC. Recent changes in recommendations for nutrition for the preterm infant such as     higher intakes of protein, calcium, and vitamin D may also play a factor in the pathogenesis     of NC.      Currently, diagnosis of NC often occurs incidentally during ultrasound evaluation for other     issues. Because there is no acute symptom or pattern of symptoms in the preterm population     associated specifically with NC, it is possible that many cases of NC may not be diagnosed.     Presently, it is impractical and costly to screen all infants for NC with renal ultrasound,     therefore there is no standard of care regarding screening for NC.      NC may have long-term effects. Studies have shown that preterm infants with NC had shorter     kidneys and a lower rate of tubule resorption of phosphorus (TRP) than preterm infants     without NC.      This study will analyze weekly urinalysis for all enrolled subjects prospectively and then     look at the incidence of NC at discharge of the enrolled subjects.   "
64741|NCT02438254|"     The researchers are studying factors that may increase the risk for alcohol and drug use in     individuals who do not have any problems with these substances. This study will be looking at     health behaviors in young adults compared to their family's health behaviors and lifestyle.      The investigators plan to study genetic differences in people with and without a family     history of alcoholism. The researchers hope to learn how a family history of alcoholism,     early life adversity and different genotypes shape personal characteristics associated with a     risk for alcoholism.   "
64768|NCT02437903|"     This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the     facial temporal regions based on the change in the score of the investigator's Temporal. This     study will be an open label, single center study.   "
66753|NCT02411981|"     This study will investigate the effects of on technique of chest physiotherapy on pulmonary     function. Effects of pulmonary function will be measured by the spirometry, body     plethysmography and by the multiple breath nitrogen washout technique.   "
64742|NCT02438241|"     Introduction: Pain is an important factor of increase of morbidity and mortality in patients     undergoing surgical procedures include thoracotomy. There are different methods of analgesia     in postoperative thoracic surgery, ranging from systemic analgesia with opioids, as well as     local anesthetics block (intrapleural, extrapleural, intercostal cryoanalgesia, etc.) in     addition to spinal blocks and Epidural blocks. In the pharmacological analgesia,     electroanalgesia has been proposed as an adjunctive treatment for the relief of postoperative     pain. Rationale: noting the lack of data in the literature regarding the use of this physical     therapy technique in order to reduce the pain in the postoperative period of thoracic surgery     and its consequences, it is relevant to the realization of a new randomized controlled trial     (RCT) to evaluate the effects of transcutaneous electrical nerve (TENS) in the post -     thoracic surgery on pain, pulmonary function and strength respiratory muscle. Objective: To     evaluate the effects of TENS on pain, respiratory muscle strength and lung function in     postoperative thoracic surgery in a Intensive Care Unit. Method: The subjects included will     be randomized into three groups randomly: control group (CG) that will hold only conventional     physical therapy, TENS group (EG) that will hold the application of TENS associated with     conventional physical therapy, TENS placebo group (GP) who will perform the application of     TENS placebo to conventional therapy. All groups carry out the assessments (digital     manometer, spirometry, visual analog pain scale) in the preoperative period, postoperative     Immediate / pre-intervention and at the end of treatment (discharge from the intensive care     unit), except for the pain that will be evaluated before and after each intervention session.     All patients receive physical therapy three times a day (morning, afternoon and evening)     during hospitalization in the intensive care unit. Intervention: The conventional group will     receive conventional therapy for hospital service. The TENS group will receive conventional     therapy and the end of that service, will be applied TENS for 30 minutes. The placebo TENS     group will receive the conventional physical therapy and the end of the service will be     installed TENS placebo, during this period the patient receives electrical stimulation for 45     seconds, shutting down at the end of this time and held position as TENS group.   "
64743|NCT02438228|"     The aim of the present study is to compare accuracy and precision of Cardiac Output (CO) by     nine different pulse contour algorithms with transpulmonary thermodilution before and after     cardiopulmonary bypass (CPB).   "
64744|NCT02438215|"     This is a single site, open-label study designed to examine dopamine transporter density     using [123I]β-CIT SPECT imaging before and following treatment with IRX4204 for a 30-day     period in early Parkinson's disease patients. In addition, clinical evaluations will be     performed to evaluate the effect of IRX4204 treatment on the motor and cognitive symptoms of     PD.   "
64745|NCT02438202|"     Electroconvulsive therapy (ECT) induces a cerebral seizure by electrical stimulation under     general anesthesia and muscle relaxation, is regarded as a highly efficient (for specific and     severe psychiatric disorders) and extremely safe modern treatment option.      Alzheimer´s disease (AD) is a neurodegenerative disorder which is characterized by     progressive cognitive deterioration accompanied by declining activities of daily living, by a     variety of behavioral disturbances and by neuropsychiatric symptoms. The clinical progression     of disease can be delayed by pharmaceutical therapies like acetylcholinesterase inhibition     (e.g. rivastigmine) for 6 to 12 months at most.      Along with the well-known biomarkers of AD (Aß- and tau-proteins) a lower brain-derived     neurotrophic factor (BDNF) level is since recently being considered as a negative predictor     for the further disease course. In animal experimental studies it was possible to arrest the     disease progression with the aid of neurotrophic substances. Many single studies, but also a     number of meta-analyses show primary gray matter atrophy in hippocampal, parahippocampal and     medial temporal brain regions.      Strikingly, ECT yields exact opposite effects to those caused by AD: an ECT series leads to     an increase of serum BDNF-levels in patients. Parallel to this observation evidence exists     for gray matter volume gain after an ECT series, especially for the hippocampus.      There is sufficient clinical experience regarding the use of ECT in AD-patients, mainly on     the basis of following indications: a) affective disorders and b) behavioral disturbances. A     positive effect of ECT on the symptoms of agitation and aggression was assessed in AD     patients alongside with a very good tolerability.      To investigate the potential salutary effects of ECT on AD the investigators designed a pilot     study with the following concept: Patients with a confirmed AD diagnosis and preexisting     stable antidementia medication over at least 6 months will receive a modified maintenance ECT     over a total of 27 weeks.      In the proposed pilot study, the investigators hypothesize that cognitive functioning of AD     patients will improve significantly and independently from affective symptoms, when initial     and final examinations are compared. The affirmation of the hypothesis would provide not only     further insight into the mechanism of action of ECT but also a very important reference point     for the development of new treatment options for a so-far incurable disease.   "
64755|NCT02438072|"     We propose here to explore systematically the association between drug-metabolizing enzymes     activity assessed by a phenotypical approach and antidepressant plasma concentration,     efficacy and tolerance in the clinical setting. During one year, patients receiving     antidepressant will be included in tis prospective clinical, naturalistic and descriptive     pilot study.   "
64756|NCT02438059|"     The purpose of this study is to determine whether a web- and app-based tool for health     promotion for social and health care workers in Denmark has an effect on body weight (primary     outcome), body fat percentage, waist circumference, blood pressure, cholesterol and blood     sugar in a 38 week intervention period.   "
65048|NCT02434250|"     The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a     prior failed phacoemulsification and Eximer Laser Trabeculectomy.   "
64746|NCT02438189|"     Objective: to gain experience with in-home use of a modified algorithm that will dose insulin     to minimize projected hyperglycemia overnight in addition to suspending the pump if     hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy     data.      Study Design: randomized controlled trial, with randomization on a night level within     subject.      Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for     at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of     age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness     in last 6 months; Living with a significant other or family member (companion) committed to     participating in all study activities, and being present and available to provide assistance     when the system is being used at night.      Sample Size: 30 subjects.      Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in     activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at     enrollment, following CGM and system assessment run-in phases, at start of clinical trial     phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use.      Major Efficacy Outcomes:        -  Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.        -  Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in          hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.      Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood     glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and     diabetic ketoacidosis.   "
64747|NCT02438176|"     The purpose of this study is to compare single groin puncture and bilateral groin puncture     during AF ablation procedure. The investigators will compare 1) the degree of patients'     discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and     4) 1-year clinical recurrence rate of AF.   "
64748|NCT02438163|"     Neuroplasticity is supposed to be altered in patients suffering from a Major Depressive     Disorder (MDD). Transcranial Magnetic Stimulation is a medical device which measures cerebral     plasticity. Several parameters of cortical excitability are available for that purpose. These     parameters are altered on patients wth MDD and these modifications are corrected after     treatment. Therefore results in the studies are very heterogeneous. Theta Burst Stimulation     (TBS) is a type a Transcranial Magnetic Stimulation (TMS) protocol and can induce cerebral     plasticity. The cerebral plasticity induced by TBS was measured on a group of patients     suffering from Asperger's disease (ASD) versus a control group. The plasticity was     significantly different in patients with ASD. The aim of our study is to study the     neuroplasticity induced by TBS on a patients with MDD.   "
64769|NCT02437890|"     Primary objective:      To assess the efficacy and safety of different dose regimens of ALX-0061 administered     subcutaneously (s.c.) to subjects with moderate to severe active, seropositive SLE compared     to placebo.      Secondary objectives:      To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate,     steroid reduction and health-related quality of life, with different dose regimens of     ALX-0061.   "
64749|NCT02438150|"     Objective: To investigate the effectiveness of an online training program on medical staff in     five public hospitals located in Sichuan, Yunnan, Hubei, and Fujian Provinces of China, on     improving fire knowledge.      Methods: Participants will be randomly divided into control (receiving non-fire video     training) and intervention (receiving hospital fire video training) groups. All participants     will complete a questionnaire of fire knowledge before and after receiving the training.      Hypothesis: If the online training is effective, it can be promoted as a convenient and     effective use of training and be promoted to other hospitals.   "
64750|NCT02438137|"     The overall purpose of this study is to determine whether the oral medication dimethyl     fumarate is an effective treatment for obstructive sleep apnea in patients who are unable,     unwilling, or uneager to use positive airway pressure therapy.   "
64751|NCT02438124|"     The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait     characteristics in Parkinson's disease (PD) are attested by clinical research.      Nonetheless, it is still unclear which auditory information parameters (i.e. complexity,     temporal regularity or adaptability to gait) maximize the effectiveness of RAS.      Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics     in PD patients with gait disorders according to:        -  RAS complexity (i.e. metronome, amplitude modulated noise, music)        -  RAS variability (i.e fixed, random, semi-random)        -  RAS adapted in real-time to gait      Variability study:      To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and     20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise     and music.      Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in     real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait     characteristics with metronome, amplitude noise and music.   "
64752|NCT02438111|"     The primary objective of this study is to assess whether compositional and functional     alterations of the gut metagenome may be related to AMD. The primary variable for this     assessment is the composition of the gut metagenome which will be analyzed by shotgun     sequencing to characterize the faecal metagenome. The secondary endpoint is to assess whether     single nucleotide polymorphisms in CFH, ARMS2, C3, PLEKHA1, HTRA-1, VEGF-A, VEGF-B, VEGFR and     APOE genes which have been shown to be risk factors for the development of AMD and other     macular diseases correlate with alterations in the gut metagenome .   "
64753|NCT02438098|"     Until now there ist no systematic investigation of the pharmacokinetic parameters of     Rivaroxaban in obese patient undergoing bariatric surgery. The aim of this study is to     investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban in obese     patients before and after bariatric surgery.      Patients receive the day before the surgical intervention the first dose of Rivaroxaban     (10mg). During the following 24 hours, 9 blood samples are taken.      The second tablet Rivaroxaban is administered on the third postoperative day, followed again     by 9 blood samples during the next 24 hours.      All other blood samples are taken independent from this clinical trial as part of the     standard medical treatment during the hospitalization. The hospital stay will not be extended     by the study. The outpatient regular follow-up takes place one month after surgery and is     combined with the last study visit.   "
66172|NCT02419560|"     The purpose of this study is to determine the optimal dosing scheme for the combination of     ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma     (MCL).   "
64757|NCT02438046|"     In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the     epithelialized connective tissue graft palatal donor site healing acceleration and in the     patient's morbidity reduction. Forty patients, with at least one gingival recession will be     treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from     the de-epithelialization of a free gingival graft. In the test group (20 patients) a     quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the     control group patients will be treated by an absorbable gelatin sponge. Patients will be     monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the     palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the     post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic     scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed     bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.   "
64770|NCT02437877|"     Purpose: To examine whether nasal breathing influences the perception of sound causing trade     between hard and soft consonants in the writing of children in school age and the incidence     of trade.   "
64771|NCT02437864|"     Airway placement after anesthetic induction in pediatric patients is routinely performed at     our institution without apneic oxygenation. When intubation is attempted by an inexperienced     (learner) provider, the attending physician intervenes if necessary before the patient     experiences excessive loss of oxygenation. The investigators plan to institute routine     supplemental oxygenation via nasal cannula during this placement. This study will examine the     effect of adding apneic oxygenation via nasal cannula on oxygen saturation.   "
64772|NCT02437851|"     This phase II trial studies surgery in treating patients with anal canal or perianal cancer     that is small and has not spread deeply into the tissues and human immunodeficiency virus     (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger     surgery or radiation and chemotherapy.   "
64758|NCT02438033|"     Deep brain stimulation for Parkinson's disease is a well established therapy. Current     practice requires tedious adjustment of stimulation settings based on frequent patient     assessments. Ultimately, the goal is to develop a system that can program itself using     signals that are recorded directly from the brain on a continuous basis. Our previous work     has identified abnormal electrical signals in the brain that are targeted for stimulation     that can potentially be used to develop a self-programming system. In this study, the     investigators will test the safety and utility of a novel adapted device that can not only     deliver stimulation to the brain but also record brain signals in a patient that is implanted     with a deep brain stimulation system. The purpose of this Phase I study is to understand the     safety of the device as well as the relationship between these electrical signals measured     from deep within the brain and Parkinson's symptoms and how these signals can be used to     guide a self-programmed system. The study will entail implanting this special device (Activa     PC+S) in place of the standard generator (Activa PC) and to compare clinical symptoms,     recorded brain signals, and stimulation patterns during a one year period after implantation.     Specifically, the investigators will use the Activa PC+S to record GPi (internal globus     pallidus) local field potentials between and during programming visits, allowing the surgeon     to better characterize a patient's disease. At the same time, the investigators will evaluate     the safety of this new device.   "
64759|NCT02438020|"     Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis     nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin     is a useful drug for conditions characterized by insulin resistance.The aim of this study is     to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as     their effects on metabolic and anthropometric variables in a sample of obese children. This     is a 12-week randomized, double-blind randomized trial involving obese children with AN to     receive either metformin or placebo.      Evaluations will be performed every three weeks. Clinical, histological and colorimetric     assessments of AN lesions will be compared initially and at the conclusion of the study.   "
64760|NCT02438007|"     The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen     receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer     (CRPC).   "
64761|NCT02437994|"     Pulmonary rehabilitation is an essential non pharmacological treatment option which reduces     dyspnea sensations, increase exercise tolerance, improves health related quality of life and     reduces the burden on health care resources (1). Pulmonary rehabilitation is likely an ideal     intervention to validate the PROactive tool as responses to pulmonary rehabilitation are     clinically significant in terms of exercise tolerance and particularly activity related     symptoms. Nevertheless, the response to pulmonary rehabilitation is variable and about one     out of three patients does not present a clinically important response. Pulmonary     rehabilitation may therefore be an intervention that allows studying the conceptual model     around the PROactive tools, anchoring the new PROs (Patient Report Outcome) to outcomes that     are well known to change with rehabilitation: exercise induced symptoms, functional exercise     tolerance and health related quality of life.      Study objectives      Main objectives      A primary aim is to test reliability of the paper-pencil versus the electronic scoring     version of the PROactive tool in terms of assessing the effect of pulmonary rehabilitation on     the components of the PROactive tool and on the mode of administration.      The secondary aim of the proposed project is to investigate the effects of a     multidisciplinary outpatient hospital-based, pulmonary rehabilitation program on: i) daily     physical activity (number of daily steps, vector magnitude unit and movement intensity and     ii) the components of the Proactive tool.      Additional study objectives      A third aim of this project is to investigate whether the magnitude of change in daily     physical activity and the components of the PROactive tool in general is associated with the     magnitude of changes in frequently used rehabilitation related end-points including,     functional capacity, exercise capacity and health-related quality of life following the     completion of a comprehensive pulmonary rehabilitation program.      A forth aim of this project is to investigate whether the magnitude of change in daily     physical activity and the components of the PROactive tool in general is associated with the     magnitude of changes in physiological indices including cardiovascular and respiratory     adaptations following completion of a comprehensive pulmonary rehabilitation program.   "
64762|NCT02437981|"     PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM     and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded     entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part     of a combined HIV prevention program that includes risk-reduction counseling, regular HIV     testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red     Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in     Thailand.   "
64763|NCT02437968|"     The present study aims to test the implementation and sustainability of (a) a     Computer-Assisted Cognitive-Behavioral Treatment (CACBT) for youth anxiety and (b) the BASC-2     TRS to identify anxious youth in the school setting using a cohort-sequential design (i.e.,     three years at 20 schools over the span of five years).      'Camp Cope-A-Lot (Computer-assisted CBT program)'   "
66868|NCT02410486|"     This prospective surveillance study will be conducted over a 2 year period to determine     current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated     pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.   "
64764|NCT02437955|"     In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50     months indicating that iron deficiency is a major health problem. The government of Senegal     has implemented a flour fortification program including iron and folate. Iron is a difficult     mineral to add to foods efficiently due to its organoleptic properties and typical low     bioavailability in man. The aim of this study is to determine iron absorption from fortified     wheat flour consumed with a phenolic containing beverage in women and child pairs. The     fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption     inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly     investigated.      The bioavailability of the different iron compounds will be determined using stable iron     isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women     between 18-45y) will be selected for participation in the study. After a screening, each     women and child will receive 4 test meals consisting of a bread roll fortified stable     isotopes with and without the tisane beverage. The first two test meals will be consumed on     consecutive days. Two weeks after the second test meal a blood sample will be taken from each     women and child before the third meal administration. After the forth test meal     administration, and again two weeks later, the last blood sampling will take place and the     study will be conducted for the subjects (duration 30 days). The samples will be sent to     Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori     infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as     well as inflammation status (CRP) will be determined.   "
64765|NCT02437942|"     Athletic groin pain (AGP) is a chronic condition common in multi-directional sports (Walden     et al. 2007, Robinson et al. 2004, Murphy et al. 2012). It is a complex injury with a     challenging diagnosis. Dramatic differences in the anatomical diagnoses of AGP cohorts exist     in the literature (Renstrom et al. 1980, Lovell et al. 1995, Holmich et al. 2007, Bradshaw et     al. 2008). This may be due to the complexity of the anatomy in the region and the absence of     magnetic resonance imaging (MAGNETIC RESONANCE IMAGE) to confirm clinical examination.      Dynamic actions undertaken in field sports (including change of direction cutting) are     particularly associated with the development of athletic groin pain (Holmich et al. 2014).     Dynamic multi-plane, multi-joint actions can overload musculoskeletal and fascial structures     in the hip and groin. Despite this, traditional groin pain assessments do not involve an     examination of sport specific actions. An examination of jumping, hopping and cutting     mechanics, which is possible with the use of three dimensional motion capture techniques,     will provide additional information with which to diagnosis and rehabilitate athletes.      While the majority of published studies on AGP have focused on surgical management (Serner et     al. 2015), exercise therapy has been found to be an effective treatment (Holmich et al.     1995). In exercise therapy studies the best results were shown by Holmich et al (1995) where     subjects suffered for an average of 9.9 months with symptoms and a strength and stability     program focused on adductor strength returned them to sport in 18.5 weeks. The latest paper     on rehabilitation by Jardi et al. demonstrates little improvement with a mean time to return     to training of 86 days +/-15. The focus remains on improving strength of isolated muscle     groups and not attempting to address underlying biomechanical abnormalities that may be     leading to overload. Accurate biomechanical assessment and individualized rehabilitation     based on the high speed multiplanar movements that drive the athlete's symptoms may enhance     the efficiency of rehabilitation. Moreover post-rehabilitation changes in biomechanical     factors may provide a further insight into the biomechanical factors associated with AGP.      The purpose of this study was to:        1. Describe clinical presentation (physical examination and magnetic resonance imaging          findings) for a group of athletes presenting with AGP        2. To describe the different biomechanical diagnoses that exist in AGP patients        3. To examine the effects of a biomechanics led exercise intervention to rehabilitate          chronic groin pain      It is hypothesised that standardised magnetic resonance imaging will aid in the anatomical     diagnosis of athletic groin pain patients. From a biomechanics perspective, distinct     subgroups/clusters will exist that differ from each other in how they undertake dynamic sport     specific actions. These distinct clusters will describe potential biomechanical diagnoses     that exist in groin pain patients. A biomechanics led rehabilitation program will return     groin pain patients back to sport more quickly than previous rehabilitation programs without     biomechanical diagnostic information.      Brief protocol Participants will be recruited from patients with chronic athletic groin pain     who present for investigation and rehabilitation at Sports Surgery Clinic, Ireland. A     standardised clinical examination will be undertaken including range of motion assessment,     pain provocation and load tolerance tests, and palpation.      A Magnetic Resonance Image of the hip and groin region will then be undertaken and read by a     consultant sports physician.      Biomechanical assessment will include capturing of jumping, hopping and cutting mechanics     through the use of three dimensional motion capture technology and force plates. Here     reflective markers are placed on the skin at anatomical landmarks. These markers are picked     up by the cameras and tracked at 200 frames per second. Participants will contact the force     plate with their foot on undertaking the movements. Force and marker data will be combined to     calculate joint angles and moments.      Physical therapy assessment will include an assessment of functional movement, range of     motion testing, adductor squeeze tests, strength assessment of hip and trunk.     Physiotherapists will utilise three dimensional biomechanical data during cutting and landing     to inform individualised rehabilitation. Rehabilitation will consist of movement control,     whole body strength and power, linear running mechanics, multi-directional mechanics and     conditioning sessions. Participants will have follow up physical therapy appointments     approximately every two weeks. A hip and groin outcome score (HAGOS) will be used to monitor     the morbidity and severity of the injury throughout the rehabilitation process.      Once the physiotherapist determines that the patient is ready to return to play a     biomechanical re-test will be undertaken.   "
64766|NCT02437929|"     This study aims to assess self reported procedural pain compared with background pain and     evaluate pain intensity differences across six standard procedures. Besides, rescue and     preventive treatments used to control procedural pain will be examined.   "
64767|NCT02437916|"     The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity,     and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.   "
64773|NCT02437838|"     The primary objectives of this study are to examine whether augmented renal clearance (ARC)     compromises renally eliminated drug therapeutic serum concentrations in patients with     traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic     serum concentrations of the probe medication levetiracetam in patients with TBI.   "
64774|NCT02437825|"     Salivary fistulae have been the bane of surgical salvage in the era of primary chemoradiation     for head and neck (H&N) cancers. The blameof prior chemoradiation tissue damage encouraged     compensatory surgical techniques that focused on the insertion of non-irradiated tissue into     the field. This study emphasizes a paradigm shift in the understanding and treatment of     pharyngocutaneous fistulae. The detrimental effects of salivary enzymes on tissue healing and     surgical anastomoses are addressed and novel treatment strategy is outlined.   "
64775|NCT02437812|"     Initially, the prospect of metformin as a neoplastic treatment was considered for     malignancies of the prostate, colon and pancreas. However, only select clinical studies     involving the use of metformin in the treatment of ovarian cancer have documented improved     survival rates. Since no first line regimen has demonstrated compelling superiority in the     management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin,     and metformin is of particular interest given the triplet's prospect for achieving increased     synergy without compromising patient tolerability.   "
64776|NCT02437799|"     BACKGROUND:      Hypotension occurs commonly during spinal anaesthesia for caesarean section and may result in     detrimental effects to the mother and foetus. A previous pilot study where images of the     pulse oximeter waveform study were taken, found that the dicrotic wave moved away from the     systolic wave during the onset of hypotension.      AIMS:      The investigators wish to download electronic data which describe the pulse oximeter pulse     wave to more accurately assess movement of the diastolic wave relative to the systolic wave     during spinal anaesthesia for caesarean section.      METHODOLOGY:      20 women undergoing caesarean section under spinal anaesthesia will be recruited by informed     consent for this observational study. Data downloaded from the pulse oximeter will be     analysed to identify movement of the dicrotic wave relative to the systolic wave and this     will be related to changes in blood pressure.      EXPECTED OUTCOMES:      The investigators will establish best way to analyse changes in the pulse oximeter waveform     and the relationship between changes in pulse oximeter waveform morphology and the onset of     hypotension during spinal anaesthesia for caesarean section.      IMPLICATIONS:      Analysis of movement of the dicrotic wave could be used to anticipate and thus avoid severe     hypotension during spinal anaesthesia for caesarean section.   "
64777|NCT02437786|"     The specific clinical trial is a part in which ALK- Abelló will directly work to explore     human immunological mechanisms of SIT (observed after GRAZAX treatment).   "
64778|NCT02437773|"     Obsessive-compulsive disorder (OCD), characterized by intrusive thoughts (obsessions) and     related behavioral rituals (compulsions), is a common psychiatric illness that often emerges     in childhood and causes life-long disability in over 50% of patients. Psychological theory     suggests that OCD symptoms are driven by a person's difficulty disengaging their feelings     from simple tasks (e.g. washing hands, locking a door) due to excessive anxiety about     performance errors. Cognitive behavioral therapy (CBT), the gold standard treatment for OCD,     repeatedly exposes patients to their OCD-stressor until this anxiety is reduced. While CBT is     typically more effective in teenagers than adults, patients from both age groups are usually     left with residual symptoms, highlighting the need for better treatments. In this study, CBT     will be studied in both teen-aged and adult patients. Two groups, both with childhood onset     OCD, will be randomized to either CBT for OCD or stress management training (SMT), an active     therapy but with minimal effects on OCD symptoms. The investigators will also study     age-matched, healthy controls as comparison subjects.      Before and after 12 weeks of CBT, all subjects will undergo functional Magnetic Resonance     Imaging (fMRI) scans to see what regions of the brain become active when a concentration task     is performed and how that activation is changed after CBT. The purpose of this study is to     demonstrate the brain changes associated with CBT treatment and how differences in these     changes in teenage compared to adult patients may drive differences in CBT response.   "
72491|NCT02336893|"     The purpose of this study is to assess whether a formal training strategy using an interview     PACIENTE may improve physician's skills and quality of communication with family members at     the ICU.   "
64779|NCT02437760|"     The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well     defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer,     including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at     advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition     of cancer cell involved pleura.      The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could     be correlated with the prognosis. This study was performed to examine the properties of     CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant     pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary     therapy as a surrogate indicator for survival.   "
64780|NCT02437747|"     A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root     planing in the treatment of chronic periodontitis patients with controlled type II diabetes     mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative     Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline     and 3 months.   "
64791|NCT02437604|"     Each patient will participate in the study for approximately 7 weeks. Participation will     include a screening period of up to 21 days and 4 treatment periods; each consisting of a     3-day/2-night inpatient period.   "
64792|NCT02437591|"     The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin     (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C.     difficile Infection (CDI).      This study will also compare CDI clinical response to the microbiological response in terms     of magnitude of reduction of C. difficile total viable count and spore count during treatment     with FDX and if achieved; the time to microbial eradication; determine time to negative CDI     toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of     FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay,     readmissions and resource utilization for IBD patients receiving FDX; record the incidence     and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life     as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.   "
64781|NCT02437734|"     Disease in coronary arteries kills more people in the UK than any other cause. The     investigators have developed a computer system ('VIRTU') which predicts blood pressure     changes inside coronary arteries. This is important because;        -  Doctors make better decisions regarding when and how to treat patients with coronary          artery disease if they have these blood pressure measurements        -  Currently, Doctors have to insert a metal wire inside the heart to measure artery          pressures which is time-consuming and requires special equipment, staff, training and          medicines.      Although this invasive technique saves lives and money, more than 95% of patients do not     receive the procedure or the benefits it provides.      VIRTU provides a solution to this problem since it only needs X-ray pictures and does not     require any wires, drugs, or additional time, equipment or staff. VIRTU has been tested and     works but needs improving before it can be used in all patients.      GOALS:      Following, and compared with, our pilot project ((Modelling the significance of coronary     artery disease, STH 15740) to:        1. Improve VIRTU's accuracy.        2. Improve VIRTU's speed.        3. Test VIRTU in patients with more complicated coronary disease.      One hundred patients will be recruited from angiography waiting lists and consented before     attending for their angiography. The patients will be asked whether their angiogram pictures     and pressure measurements maybe used as part of the data collection for this study. The data     will be used to validate and develop VIRTU to make it 'patient-ready'. VIRTU will deliver all     the advantages of the current invasive technique (i.e. reduced deaths, heart attacks and     cost) but, is less invasive and usable in 100% patients.   "
64782|NCT02437721|"     The study is designed to show equivalence of an infant formula containing L-5-     Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in     respect to weight gain of healthy term infants receiving these infant formulae exclusively     during the first 4 months of life. Healthy non breast fed infants will be randomized to     receive either a standard infant formula with folic acid or a corresponding formula with MTHF     instead of folic acid. Besides weight and length further anthropometric measures will be     taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16 weeks     blood samples will be taken for the determination of folate status and genotyping. As a     reference the same measures will be taken in a group of breast fed infants, whose mothers`     folate status will be determined as well.   "
64783|NCT02437708|"     This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF) on     the periapical bone healing and further root development of infected immature permanent     teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as     scaffold, in the control group REP without L-PRF is performed .   "
64784|NCT02437695|"     Although a condition for surgery, robotic interventions applied with steep     Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral neuropathy     if good position is not achieved on the operating table. This study will be a 7-year     retrospective examination of postoperative positional injury (PPI) in patients undergoing     robot-assisted radical prostatectomy (RARP) for prostate diagnosis.   "
64785|NCT02437682|"     The PASS test is only available and valid tool for the evaluation of persistent acid-related     symptoms in patients receiving PPI therapy. There is lack of a validated Chines version of     PASS questionnaire for the GERD patients with partial response to proton pump inhibitor     (PPI). The English version of PASS test will be translated to traditional Chinese by using     forward-backward procedure, and the Chinese version of PASS test will be validated its     psychometric properties in Hong Kong population.      Eligible subjects will be invited to administer questionnaires to evaluate the psychometric     properties of the Chinese version of PASS test.   "
64786|NCT02437669|"     Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It     has not been previously studied in children, but may be a viable option for effectively and     safely reducing pain in children by administering an analgesic by the intranasal route.      This study will be a prospective, open-label pilot study of intranasal hydromorphone in     children with moderate to severe acute pain presenting to the pediatric emergency department.     The investigators aim to describe the amount of pain reduction associated with intranasal     hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with     a clinically meaningful improvement in acute pain.   "
64787|NCT02437656|"     Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis.     Historical cohort of patients with diabetes have shown that diabetics on Metformin had a     better chance of survival than diabetics not on Metformin. These observations have led to in     vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has     anti-proliferative properties.      The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant     radiochemotherapy in the treatment of locally advanced rectal cancer.   "
64788|NCT02437643|"     The purpose of the trial is to assess the effects of combining regular, generous intakes of     high quality protein (primarily from dairy and other animal source proteins) with calorie     restriction and low-intensity exercise on muscle quality and muscle adipose infiltration     (along with bone mineral density [BMD] and a number of secondary outcomes) in frail, obese,     older adults participating in a 6 month intervention. The investigators will compare these     effects to those of a traditional control regimen of calorie restriction and low-intensity     exercise over the same duration.   "
64789|NCT02437630|"     In this study the investigators aim to investigate the extent to which in patients with     chronic obstructive pulmonary disease narrowing of the vocal cords causes a positive pressure     within the airways thus improving airflow and lung function. This information will be     captured in the upright and lying down positions and an estimate of the magnitude of the     effect will be formed by offsetting the pressure by asking the patients to breathe using a     commercially available device used to treat sleep apnoea called a CPAP machine. This is an     observational study in which the observation of laryngeal aperture, and mouth and oesophageal     pressure at differing levels of applied CPAP will be recorded for analysis in patients with     COPD and in normal subjects without COPD. All will have the same measurements, observations,     and interventions to allow us to observe and measure pressure, laryngeal aperture, and     airflow .   "
64790|NCT02437617|"     The goal of this research study is to collect and test tumor tissue from patients with     advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers     will study if the results from genetic testing can help researchers determine which therapy     may prove more beneficial for a patient in the future.   "
64793|NCT02437578|"     Today, it is evident that vitamin D has more widespread effects than the classical actions     related to bone mineralization and calcium homeostasis. Vitamin D deficiency results in     impaired reproductive performance in various species of animals, and recently the     investigators have shown that the Vitamin D receptor (VDR), activating (CYP2R1, CYP27A1,     CYP27B1) and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis,     seminal vesicle, prostate and spermatozoa. Functional studies showed that activated vitamin D     increases intracellular calcium and sperm motility in mature spermatozoa, and hence may be     important not only for spermatogenesis but also for sperm function. Any test that might     assist in guiding the treatment of the infertile couple would be beneficial both for most     infertile couples and the society in general. The fact that vitamin D may play a role for     human semen quality are now being tested clinically. If vitamin D supplementation proves     efficient this opens for the first time for a causal, safe and cheap treatment of at least     some cases of idiopathic impaired semen quality. This may also have consequences in the in     vitro setting as activated vitamin D may be used to select high quality sperm during assisted     reproductive techniques. The presence of the vitamin D receptor and vitamin D metabolizing     enzyme CYP24A1 in particular is able to discriminate spermatozoa from normal and infertile     men. CYP24A1 is expressed at the annulus of normal sperm, but it is virtually absent from     spermatozoa from infertile men. This indicates that CYP24A1 expression may assist in     predicting the chance of success by using insemination (IUI), IVF or ICSI. CYP24A1 expression     is induced by activated vitamin D, which indicates that other VDR activated genes also may     serve as positive predictive markers of fertility. In addition, vitamin D metabolites and     other factors in the female reproductive tract will be measured to determine if they alone or     in combination with other markers can determine whether the best solution for the infertile     couple would be to do IUI, IVF, or ICSI. The suggested clinical trial may therefore be able     to evaluate several secondary endpoints in addition to CYP24A1 in our search for predictive     markers for fertilization. For instance several biomarkers in serum, seminal plasma or     follicular fluid in conjunction with genetic polymorphisms in several genes important for     reproductive function.   "
64794|NCT02437565|"     Stainless steel crowns are arguably the most successful posterior restorations in primary     teeth and have been so for more than 50 years. Stainless steel crowns offer durability and     success rates in excess of 95% making them the restoration of choice for posterior primary     teeth in children treated under general anesthesia.      Failures of stainless steel crowns placed on primary teeth have been documented using several     criteria including marginal adaptation, recurrent caries, abscess formation or root     resorption, loss of the crown due to faulty retention and even perforation of the crown .     Despite the probability that factors such as root resorption and failure of endodontic     treatment could be due to traumatic occlusion, surprisingly little evidence is available in     literature on the attempts made to check or evaluate the occlusion of stainless steel crowns     placed under general anesthesia The aim of this study was to compare the time taken for     placement and the overall success of bilateral multiple stainless crowns placed under general     anesthesia using an occlusal index and compare them to crowns placed without such an index,     using a randomized control study design   "
64795|NCT02437552|"     The prevalence of heart diseases has increased significantly in recent years and it is a     health public problem due to an increased risk of death by several reasons. A cardiac surgery     is an alternative of treatment for critical injuries heart valves and coronaries arteries.     Changes in respiratory system resulting from cardiac surgery are well established and include     a reduced functional capacity due post-surgical pain, causing increased respiratory function     and increased oxygen consumption . The exercises with the cycle ergometer in phase I of     cardiac rehabilitation can improve peripheral muscle strength, functional capacity and     perception of dyspnea when used postoperatively and there are speculations if an earlier     carried out can contribute to a better postoperative evolution of patients, but these     benefits in phase I of the Rehabilitation Cardiac are not well defined in the literature.     Objective: To evaluate the exercises effects with ergometer cycle in the postoperative course     of patients undergoing cardiac surgery. Method: Patients will be recruited the cardiac     surgery service of Polyclinic Pato Branco in the city of Pato Branco in state of Paraná, of     both sexes, appropriate for the inclusion criteria, which will be evaluated by pulmonary     function tests (strength of respiratory muscles, submaximal exercise test, dyspnea scales,     laboratories tests and radiological exam). All patients will be randomly assigned for one of     two groups: the control group (Conventional treatment) and rehabilitation group (conventional     treatment +cycle ergometer), for about 7 days at postoperative period. Patients will be     reevaluated on the third postoperative day and at discharge. Clinical evolution data will be     collected from the records and notes of the medical staff and monitoring physiotherapist.   "
65157|NCT02432833|"     The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based     immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months     following de novo renal transplantation in a real-life setting in different European     Countries.   "
64796|NCT02437539|"     The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for     PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential     of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and     less aggressive tumors. This is a first in human study to test the radiotracer in cancer     patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10     minutes, 1 hour and 2 hours post injection).   "
64797|NCT02437526|"     This study is designed to determine if individual patients with HIV infection have been cured     of the infection. To do this, antiretroviral therapy is discontinued under close medical     supervision and the patient monitored over time for reactivation of infection.   "
64798|NCT02437513|"     Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy     (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences     of aspiration and respiratory tract complications such as aspiration pneumonia. Current     standard of care treatment to reduce the consequences of aspiration is often a tracheostomy     which has its own risks and complications. The proposed study aims to describe the     performance of a new CE marked medical implant, the NewBreez, in protecting the patient's     airways from aspiration.   "
64799|NCT02437500|"     This is an open-label study for patients who have a recurrence of Clostridium difficile     infection in the first 8 weeks of participation in the SERES-004 study. As the SERES-004     study has completed enrollment, SERES-005 was amended to allow expanded access in accordance     with 21 CFR 312.315 to SER-109 for patients with recurrent CDI who would have qualified for     the SERES-004 study.   "
64800|NCT02437487|"     The study will involve administering the study drug as a single dose of study drug or     placebo. This study is designed to demonstrate the superiority of the experimental drug     versus placebo in adult patients with recurrent CDI.   "
64801|NCT02437474|"     The purposes of this study are        -  to test the hypothesis that elimination or reduction of dietary animal proteins leads to          an improved prognosis in tumor patients        -  to estimate the effect size and thus to enable sample size calculations for further          studies        -  to test the feasibility and tolerance of different diets, especially a vegan diet, in          cancer patients and to proof that a vegan diet does not lead to a deterioration of          health, tumor progression or to malnutrition        -  to test the online platform as a study platform        -  to test validity of self reported and online generated data   "
64802|NCT02437461|"     This prospective randomised controlled single blind trial comparing the relapse rate in 6     months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (Lederspan®) for knee     synovitis in patients with rheumatoid arthritis (RA) and psoriatic artritis (PsoA) is     performed to find the optimal dose to use.   "
64803|NCT02437448|"     The aim of the study is to answer the question whether a disease specific profile of breath     in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study     using exhaled breath analysis by mass spectrometry.   "
64804|NCT02437435|"     Ivanovski shows that by studying the vascular impedance can calculate the optimal uterine     receptivity in IVF. A reduced vascular resistance and increased blood flow rate improves the     chance of pregnancy.      Dr. Luis T. Mercé says: After evaluating 40 cycles of IVF (In Vitro Fertilization) have     found that the pregnancy rates increases with increasing endometrial volume. It has also     advocated that the endometrial blood flow better reflects uterine receptivity, since the     endometrium is where will take place the embryo implantation. Merce also claims to have found     that the pregnancy rate increases with increasing endometrial volume and no pregnancies were     achieved with endometrial volume less than 3 ml.      These statements motivate us to perform a research project to monitor changes that occur in     the uterine endometrial vascularization and subendomertial vascularization after applying a     manual physiotherapic technique in menopausal women.      Various authors report that by osteopathic techniques applied on visceral structures,     vascular flow rate of the treated bodies increased.      In the literature there are not articles on the subject at hand, but there are references to     the manual techniques in the treatment of women with infertility where they state that the     manual action for lymphatic congestion in the pelvic region facilitates pregnancy in women     infertile.      The practice of visceral osteopathy offers the possibility of accessing the treatment of     uterine functional disorders, as well as structures such as uterine ligaments. They influence     the fluidic efficiency of uterine arteriovenous system. According to Salamon E., W. Zhu and     Stefano GB., provides enough tools to improve the movement of fluids and uterine     vascularization.   "
64805|NCT02437422|"     A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact     on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease     (ESRD).   "
64806|NCT02437409|"     ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox     GmbH* Germany) will be examined. The effectiveness, safety and the long-term success when     using the pREset to treat acute occlusions of cerebral vessels will be analyzed.      *German: Gesellschaft mit beschränkter Haftung, limited liability company   "
64807|NCT02437396|"     The objective of this study is to evaluate oxidative stress and/or inflammation in patients     with Gaucher disease type I using a series of biomarkers and correlate with measurements of     currently used diagnostic biomarkers.   "
64820|NCT02437227|"     The study is a first in man, dose escalation study to evaluate the safety, tolerability and     how the drug works in the body in patients with all solid tumours. The aim of this study is     to determine the most effective dose of the study drug that can then be further investigated     in patients with advanced melanoma.   "
64821|NCT02437214|"     A single blinded controlled trial to determine if an intervention of listening to nursery     songs with integrated heart beat sounds results in changes in anxiety level in infants and     young children less than four years of age in an emergent setting.   "
64822|NCT02437201|"     Previous studies indicated high frequency of abuse in families and its consequences.     Considering the importance of interventions such as educational interventions, in order to     increase women's abilities to prevent abusive behaviors, the current research aims to     determine the impact of an Liberty program on prevention of violence against women and     propose solutions for less damages and consequences.   "
64808|NCT02437383|"     Purpose:      Primary: To evaluate the efficacy of extended-release propranolol compared to placebo for     reducing pain in patients with temporomandibular disorder (TMD).      Secondary: To determine if extended-release propranolol efficacy varies according to     participants' catechol-O-methyltransferase (COMT) genetic diplotype.      Exploratory: To investigate whether the effect of extended-release propranolol on the     incidence of adverse effects, use of rescue medication, or pain index varies according to     polymorphisms in the noncoding regions of COMT, adrenergic receptor β2 (ADRβ2), or adrenergic     receptor β3 (ADRβ3) genes.      Participants:      200 patients with chronic TMD will be randomly assigned, in a 1:1 parallel, double-blind     fashion, to receive either extended-release propranolol or placebo at one of three study     sites: University of North Carolina-Chapel Hill School of Dentistry; University of     Florida-Gainesville College of Dentistry; and the State University of New York at Buffalo     School of Dental Medicine.      Procedures (methods):      Randomization will be to either propranolol or placebo. The 10-week study treatment period is     divided into: 1 week of drug titration, 8 weeks of drug maintenance, and 1 week of drug     tapering. The titration and tapering doses are 60 mg (capsules) once per day orally; the     maintenance dose is 60 mg twice per day orally. Participants will attend 6 clinic visits over     12-15 weeks as follows: screening and baseline visit (Visit [V] 0, 7-21 days prior to V1);     randomization and start of treatment (titration) (V1, study day 0); maintenance visit 2 (V2,     1 week post-randomization, study day 7+3); maintenance visit 3 (V3, 5 weeks     post-randomization, study day 35 +/- 7); tapering visit (V4, 9 weeks post-randomization,     study day 63 +/- 7); and tapering visit 5 (V5, 11 weeks post-randomization and 1 week after     drug tapering ends, study day 77 +/- 7). Depending on the visit, procedures will include:     reviews of medical history, weekly alcohol consumption, concomitant therapies and     medications, adverse events, compliance, and eligibility; administration/review of     questionnaires; blood draw; pregnancy test in women of childbearing potential; and dispensing     of study drug.   "
64809|NCT02437370|"     This phase I trial studies the side effects and best dose of pembrolizumab when given     together with docetaxel or gemcitabine hydrochloride in treating patients with previously     treated urothelial cancer that has spread to other places in the body and usually cannot be     cured or controlled with treatment (advanced) or that has spread from the primary site (place     where it started) to other places in the body (metastatic). Monoclonal antibodies, such as     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs     used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways     to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving pembrolizumab together with docetaxel or     gemcitabine hydrochloride may be a better treatment for urothelial cancer.   "
64810|NCT02437357|"     The purpose of the present randomized-controlled trial is to investigate the efficacy of     Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group     intervention.   "
64811|NCT02437344|"     Opioid dependence is a substantial problem associated with significant morbidity and     mortality. Extended-release naltrexone has been found effective at reducing opioid use and     maintaining abstinence, but its use has been limited by the difficulties encountered with     treatment initiation, which involves detoxification from opioids and oral naltrexone     titration. Improving the likelihood of a successful transition to naltrexone is therefore an     important public health goal.      N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and     symptoms of withdrawal from opioids, as well as to address adaptations associated with     chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These     benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore     facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and     ameliorating adaptations associated with drug dependence, such as craving and arousal.      The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone     initiation in opioid dependent individuals. After administration of extended-release     naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care     subsequently (oral naltrexone, extended-release naltrexone).   "
64812|NCT02437331|"     The purpose of this study is to explore the experience in being with advanced Heart failure     patients.   "
64813|NCT02437318|"     To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free     survival compared to fulvestrant and placebo in men and postmenopausal women with hormone     receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment     with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.   "
64814|NCT02437305|"     This study will examine the effectiveness of a targeted, health literate educational     intervention for people of color compared to a standard melanoma education pamphlet for     increasing knowledge and promoting early melanoma detection. It is hypothesized that people     of color are less aware of their risk for developing melanoma and that a targeted educational     intervention will help increase knowledge and promote early melanoma detection especially in     individuals with low health literacy.   "
64815|NCT02437292|"     The purpose of this study is to determine the effect of ischemic compression with stretching     on pain related parameters including pain intensity, pressure pain threshold, anxiety,     cervical range of motion and patient satisfaction in patients with scapular pain associated     with myofascial trigger point.   "
64816|NCT02437279|"     This is a two-arm Phase 1b feasibility trial consisting of 20 patients receiving the     combination of ipilimumab+nivolumab, either adjuvant, or split neo-adjuvant and adjuvant.   "
64817|NCT02437266|"     The purpose of this study is to determine the effect of scapular mobilization on pain related     parameters including pain intensity, pressure pain threshold, muscle tension, anxiety,     Scapular range of motion, patient satisfaction in patients with scapular pain associated with     myofascial trigger point:   "
64818|NCT02437253|"     The purpose of the study is to collect preliminary data on whether the drug adalimumab (also     called Humira) can decrease pain and stiffness, improve quality of life, and is safe in     people with mucopolysaccharidosis type I, II, or VI. In this study people will be randomly     assigned to one of two groups. One group will be treated with adalimumab the first 16 weeks     of the study and then with a saline injection for the last 16 weeks of the study. The other     group will start with the saline injection for 16 weeks and then switch to adalimumab for the     last 16 weeks. The study subject and the study doctor and study coordinator will not know     what group a subject is in until the study is done. Adalimumab is given as an injection, just     under the skin, every 2 weeks. Both groups will have blood drawn at a screening visit, and     then 7 more times over the 32 week study. There will be safety labs done (liver and immune     function tests). Other safety tests include a chest X-ray and screening for tuberculosis     exposure - these will be done at the screening visit and later in the study if there is     concern for tuberculosis exposure or a persistent cough. The following will also be done at     screening, the first, middle, and last study visits: 1) a pregnancy test in all girls 8 and     older, 2) questionnaires that ask about pain, how MPS impacts social and physical function,     and other quality of life questions, 3) height and weight. Finally, a physical exam, that     includes for children and adolescents a check of where they are in puberty, will be done by a     study physician at the first, middle, and last visits. There are risks to taking adalimumab     that include redness and pain where the injection is given, a decreased ability to fight off     infections, and others. The safety tests are designed to identify and decrease the risk     associated with adalimumab. The study physicians believe that the potential benefit of     adalimumab on pain, quality of life, and other MPS related problems outweigh the potential     risks of treatment.   "
64819|NCT02437240|"     The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary     physical therapy (CPT) for in-patients after cardiac surgery.   "
64823|NCT02437188|"     A large number of veterans suffer from distress-based conditions, such as anxiety and     depression, putting them at high risk of experiencing persistent pain and prolonged opioid     use following surgery. These connections are based on strong and consistent evidence from the     literature and our preliminary data. The proposed study adds a 1-day workshop of Acceptance     and Commitment Therapy (ACT), followed by an individual booster session, to treatment as     usual (TAU) to reduce veterans' risk of persistent pain and prolonged opioid use following     surgery. ACT has been shown to be effective in reducing chronic pain, anxiety and depression.      This pilot study will establish the feasibility and preliminary efficacy of incorporating ACT     into treatment as usual (TAU) to preoperatively target distress-based risk factors. Aim 1 is     to establish the feasibility of successfully delivering ACT to at-risk veterans before and     after surgery. Aim 2 is to test the preliminary efficacy of ACT on the length and/or amount     of pain and opioid use after surgery. Veterans who are anxious or depressed before surgery     will be randomly assigned to receive ACT plus TAU or TAU. Outcomes between the two groups     will be compared. Aim 3 is to see if PROMIS modules, developed by the National Institute of     Health, are useful for assessing pain and other symptoms in veterans. Findings from this     study will be used to inform the design and implementation of a larger, well controlled,     randomized clinical trial that will evaluate the efficacy of ACT plus TAU for at-risk     veterans.      This study will take place at the Iowa City VA Health Care System (VAMC). Veterans scheduled     for orthopedic or open abdominal surgery in 1 to 3 months who score high for anxiety or     depression will be randomly assigned to attend a 1-day ACT workshop preoperatively, with an     individualize booster session postoperatively, or to have TAU. Veterans who receive ACT and     trainers who provide the treatment will be interviewed to identify barriers and facilitators     to providing ACT to at-risk veterans before and after surgery. Other primarily outcomes are     pain and opioid use after surgery. Factors that may affect these outcomes will also be     measured, including anxiety, depression, substance use disorder, post-traumatic stress     disorder, and use of other pain meds.      The investigators expect to gain important knowledge about ways to best include ACT as part     of routine care for veterans requiring surgery and about the preliminary efficacy of ACT for     the prevention of persistent pain and prolonged opioid use following surgery.   "
64824|NCT02437175|"     The primary objective of this pilot study is to evaluate the efficacy of trace elements,     versus placebo, on the reduction of pain in endometriosis of an American Fertility Society     (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4     months.   "
64825|NCT02437162|"     The purpose of this study is to assess the efficacy of ustekinumab, in adult participants     with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha     agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.   "
64826|NCT02437149|"     The study will measure the effectiveness of a distracted driving campaign in the emergency     department in teenagers, 15 to 18 years old, to determine if it changes their attitudes     towards texting while driving. It will also assess previous knowledge and behaviors in this     age group, regarding distracted driving and what educational tool (power point vs. videos vs.     brochure) has the most impact changing the attitudes towards texting and driving.   "
65050|NCT02434224|"     This study investigates whether creative music therapy applied to premature infants will     facilitate brain growth and development at term equivalent assessed by magnetic resonance     imaging. Secondary objective are improvement of neurobehavioral outcomes of premature infants     at 24 months, as well as at 5 years of age.   "
64827|NCT02437136|"     The purpose of this study is to determine the safety and tolerability of entinostat used in     combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the     purpose of the study is to assess how effective entinostat and pembrolizumab are in     combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair     Proficient Colorectal Cancer   "
64828|NCT02437123|"     This study will examine the effect of a culturally-safe two-way supportive text message     intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs     in a community-based setting.      The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and     Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince     George, British Columbia, Canada. Indigenous collaborators and investigators, collectively     known as the Cedar Project Partnership, govern the entire research process.      A stratified Zelen pre-randomized design will be used to identify a random selection of     cohort members to be offered the Cedar Project mHealth intervention with consent.     Participants in the intervention arm will receive a package of supports, including a mobile     phone and long-distance plan, weekly two-way supportive text messaging via the WelTel     platform, and support from Cedar Advocates. Those drawn from the cohort study population as     the comparison group will continue on in the usual Cedar Project study under its existing     informed consent with no change whatsoever to their participation in the overall study.      The main outcome is an HIV propensity score, assessed at six months and one year. Secondary     outcomes include HIV risk, resilience, access to drug-related services, psychological     distress, and connection to culture measured at six months and one year. Primary analysis is     by intention to treat.   "
64829|NCT02437110|"     Background:      - Some people with Amyotrophic Lateral Sclerosis (ALS) have a high level of the virus HERV-K     in their blood. Researchers do not think this virus causes ALS. But they don t know why some     people with ALS have a high level of it. They want to know if HERV-K can be suppressed by     drugs that are used to treat HIV infection.      Objectives:      - To learn how drugs usually taken for HIV infection affect people with Amyotrophic Lateral     Sclerosis (ALS).      Eligibility:      - Adults at least 18 years old with ALS and high levels of HERV-K but no HIV.      Design:        -  Participants will be screened with medical history, physical exam, and blood and          breathing tests.        -  Visit 2: participants will have medical history, questionnaires, and blood drawn. Their          strength will be tested by pushing on a machine. They will blow into a tube that          measures the air they can hold in their lungs.        -  After Visit 2, participants will start taking the 4 study drugs twice a day.        -  Participants will have study visits at Weeks 1, 2, and 4, then every 4 weeks until Week          36. They will be asked how they are feeling and have an exam and blood drawn. At 2          visits, they will have tests of strength, breathing, and their ALS symptoms. Some visits          may be done at their ALS doctor s office.        -  At Week 24, they will stop taking the study drugs.        -  After the Week 36 visit, their participation is finished.   "
64835|NCT02437032|"     A key challenge facing reproductive biologists is the integration of the knowledge about     oocyte-secreted factors into coherent physiological mechanisms of how oocytes govern     folliculogenesis, cumulus cell function, and oocyte and embryo development. Although key     oocyte-secreted factors have been identified, understanding their modes of action is     complicated by multiple interactions between maternal and oocyte signaling molecules, as well     as the constantly changing state of physical interactions between the oocyte and its     companion somatic cells during folliculogenesis. Thus, the investigators study aimed to     determine if there is any relationship between different gonadotropin preparations and     oocyte-secreted factor secretion, the endocrine pattern in follicular fluid, and the     apoptotic rate in cumulus cells during controlled ovarian stimulation.   "
64830|NCT02437097|"     Many studies have examined the effects of aerobic exercise and playing video games effects on     cognitive performance, which results of which have shown to increase cognitive performance.     Presently, there is limited research regarding the effects of the combination of gaming and     exercise on cognitive performance. The purpose of our study is to investigate the effects of     playing video games, aerobic exercise, and a combination of gaming and aerobic exercise on     cognitive performance. Forty healthy subjects, males and females (18-30 years old) who     perform moderate exercise at least two times a week will comprise our sample. The study will     be a randomized clinical trial with four independent variables: playing video games, aerobic     exercise, a combination of simultaneous gaming and aerobic exercise and a control condition.     Aerobic exercise will be performed at an intensity of 60 to 70% of maximum heart rate on a     Monarch Lower Body Ergometer. Brain Age Game: Train Your Brain in Minutes a Day! will be     played on Nintendo 3DS. Executive function will be measured using the Stroop test and Trails     B pre and posttest. Analysis of variance for Stroop test and Trails B will be used. In the     event of significant F statistics, a post hoc test analysis will be used. The investigators     hypothesize a combination of aerobic exercise and simultaneous gaming will produce the     greatest increase in cognitive performance. Furthermore, these beneficial changes can be     utilized in rehabilitation protocols designed to improve cognitive functioning.   "
64831|NCT02437084|"     There is general agreement that statin-treatment of patients with high cholesterol can     increase the incidence of type 2 diabetes (T2DM) in some individuals. This research proposal     will study what metabolic characteristics and variables (for example high cholesterol or high     triglycerides or both) will identify those people at highest risk of statin-induced T2DM. The     investigators will evaluate how the medication atorvastatin (trade name Lipitor) works in     regards to its effect on insulin action and insulin sensitivity to help further understand     the possible cause of the increased occurrences of T2DM in people who are at risk for T2DM.      Under Dr. Snyder, a Co-director of the study, samples will be collected for integrated     Personal Omics Profiling (iPOP), a monitoring approach developed by Dr. Snyder and his     research colleagues. The investigators propose to analyze iPOP of individuals who participate     in this study during and after taking the statin. In this pilot study, analysis will be done     on previously-known drug effectiveness but also untargeted drug's effectiveness, (other     unknown benefits this medication may have) and drug effects such as those seen in some     participants when given a statin. The hope then is to obtain a better understanding of how to     perform a personal omics profile when taking drugs, which would lead to develop better use of     drugs.   "
64832|NCT02437071|"     The radiation therapy or ablation that the patient received as standard therapy treated only     the tumors that were radiated or ablated. Radiation therapy or ablation plus pembrolizumab     might lead to a stronger immune response that may control or destroy tumors that did not     receive radiation therapy or ablation. The purpose of this study is to find out what effects,     good and/or bad, pembrolizumab has on the patient, and the cancer that did not receive     radiation therapy or ablation.   "
64878|NCT02436473|"     The purpose of this study is to evaluate the effect of the test toothpaste containing 1150     parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel     specimens, in an in situ caries model system, by comparing the differences in net     remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm     F) reference control toothpaste.   "
64833|NCT02437058|"     The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency     departments have not achieved an adequate discriminative ability for decision making.     Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a     good predictive ability of the model.2) Create and validate clinical predictive rules of     mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days     after ED visit as well as identify predicitive factors of short-term readmission (90     days)Design: Prospective cohort study. The sociodemographics and clinical variables will be     collected from emergency medical records to identify predictors. Outcome variables and     evolution of variables will be collected from hospital medical records / ambulatory during     admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary     variables will be identified through logistic regression models using 60% of the final     sample. The models that best fit will be applied in 40% of the sample to assess the     predictive validity of this scale.   "
64834|NCT02437045|"     Infections of the blood are extremely serious and require intravenous antibiotic treatment.     When the infection results from antibiotic resistant bacteria, the choice of antibiotic is an     extremely important decision. Some types of bacteria produce enzymes that may inactivate     essential antibiotics, related to penicillin, called 'beta-lactams'. Furthermore high level     production of these enzymes can occur during therapy and lead to clinical failure, even when     an antibiotic appears effective by laboratory testing. However, this risk of this occurring     in clinical practice has only been well described in a limited range of antibiotic classes in     a type of bacteria called Enterobacter. There is currently uncertainty as to whether a     commonly used, and highly effective antibiotic, called piperacillin-tazobactam is subject to     the same risk of resistance developing while on treatment. Infections caused by Enterobacter     (and other bacteria with similar resistance mechanisms) are often treated with an alternative     drug called meropenem (a carbapenem antibiotic), which is effective but has an extremely     broad-spectrum of activity. Excessive use of carbapenems is driving further resistance to     this antibiotic class - which represent our 'lastline' of antibiotic defence. As such, we     need studies to help us see whether alternatives to meropenem are an effective and safe     choice. No study has ever directly tested whether these two antibiotics have the same     effectiveness for this type of infection. The purpose of this study is to randomly assign     patients with blood infection caused by Enterobacter or related bacteria to either meropenem     or piperacillin/tazobactam in order to test whether these antibiotics have similar     effectiveness.   "
64836|NCT02437019|"     The purpose of this study is to provide early access to Ibrutinib treatment for participants     with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety     data while the medication is not commercially available.   "
65141|NCT02433041|"     The purpose of this study is to find out whether postoperative delirium can be more properly     prevented by the combination of determined preventive agents in past studies. Further on the     investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and     S-100beta levels.   "
64837|NCT02437006|"     This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are     recruited, and they are assessed and recorded with clinical characteristics, sympathetic     nerve testing, and twice symptom-limit exercise capacity tests. The second stage would     recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three     groups (control, low-intensity, high-intensity). They are evaluated before and after the     four-week interval with clinical characteristics and twice symptom-limit exercise capacity     tests (baseline and after four-week training) .   "
64838|NCT02436993|"     The purpose of this phase II is to study the efficacy and toxicity of carboplatin and     paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel     with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast     cancer.   "
64839|NCT02436980|"     OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early     period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde     cholangiopancreatography) METHODS:This randomized and double blind study was performed with     forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned.     Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg     midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who     were randomly divided into two premedication groups.      Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric     rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was     considered as cognitive impairment. Recovery period, post-procedure state of cognitive     function at 60th minute were recorded.   "
64840|NCT02436967|"     Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA     classification (American Heart Association)- comparison between histology and CT. The CT is     performed with a fast kVp-switching dual energy technique.      To compare the ability to detect iodine contrast enhancement in the carotid plaque compared     with 3T MRI with gadolinium.   "
64850|NCT02436837|"     Background:      Taking into consideration the ongoing inversion of the population pyramid and the limitations     and medical conditions, which predispose to episodes of falling among elderly people, the     implementation of exercises and physical treatments capable of promoting postural balance in     the group studied is made necessary.      Objectives:      Assess the influence of the electronic platform Kinect Sensor® (KS) as a tool in the     treatment of postural balance in elderly individuals. Method: The study included 10 elderly     (60 to 70 years old) and 10 young (20 to 30 years old) individuals. Treatment protocol     composed of five weeks with sessions performed twice a week with application of KS. Initial     and final evaluation included static and dynamic balance instruments: Berg Balance scale and     Timed up and Go and Romberg Tandem tests.   "
64841|NCT02436954|"     While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to     achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic     cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade     (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to     achieve optimal surgical space condition.      this difference in the pressure of intra-abdominal CO2 insufflation due to different     strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in     patient's respiratory pattern and cerebral oxygenation. Although previous study (studies)     showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin     (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic     cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB     and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and     cerebral oxygenation, so far.      The present study determines and compares the changes CO2 absorption and cerebral oxygenation     (cerebral perfusion) after applying CO2 insufflation with different intra-peritoneal pressure     8 vs 12 mmHg during deep-NMB.   "
64842|NCT02436941|"     For most cancers, long-term follow-up is the best measure of treatment effectiveness. The     Department of Radiation Medicine at Loma Linda University Medical Center operates the James     M. Slater, M.D., Proton Treatment and Research Center, the world's first hospital-based     proton treatment facility. Patients have been treated at the Center since 1990. Radiation     treatment has been expanded and refined since the Center's opening, and these changes have     been based primarily on outcomes seen and evaluated in long-term follow-up.      The Radiation Medicine Patient Registry (a multi-year database), which began as an     IRB-approved study in 2003, including detailed follow-up of study data collected from 1990     and onward, is designed to track all medical information from patients treated with proton     therapy and/or conventional X-ray therapy at Loma Linda University Medical Center.     Information gathered from patients treated years or even decades ago helps to determine the     most effective use of proton and conventional radiation in caring for patients with cancers     and other diseases.   "
64843|NCT02436928|"     This study aims to evaluate the safety and immunogenicity of an inactivated cell culture     derived H7N9 vaccine in healthy adult subjects.   "
64844|NCT02436915|"     The objective of this study is to determine whether augmentation of prefrontal brain     excitability using noninvasive transcranial direct current stimulation (tDCS) lessens the     severity of the symptom triad associated with cerebral microvascular disease (CMD); that is,     slow gait, cognitive dysfunction and depressive symptoms. Investigators will complete this     objective by conducting a pilot, double-blinded randomized controlled trial of a 10-day     intervention of real versus sham tDCS in 40 subjects.   "
64855|NCT02436772|"     This study evaluates the performance of a blood test for detecting biomarkers in metastatic     breast cancer patients at one clinic against standard testing.   "
64856|NCT02436759|"     This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic     Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and     comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.   "
64865|NCT02436642|"     The devices used in this observational registry are the Osprey Medical Contrast Monitoring     System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE Mark     designations. The purpose of this registry is to evaluate the usability characteristics of     the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal     clinical use.   "
64845|NCT02436902|"     Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to     increase in many countries in coming decades. Though prognosis for patients with HCC is     generally poor, hepatic resection can be an effective curative treatment, and its indications     have been expanding in recent years. Resection can be reasonably safe and effective even for     patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as     high as 74% for patients with intermediate and advanced HCC after resection. Microvascular     invasion is one of the main risk factors which influence risk of HCC recurrence and patient     prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after     resection is so important to improve patient prognosis.      Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in     reducing early recurrence rate and mortality for patients with HCC with risk factors of     recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the     efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting     to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE     plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular     invasion.   "
64846|NCT02436889|"     An 8-week randomized, controlled, pilot clinical trial of Mirabegron compared to a standard     anticholinergic therapy (Detrol LA) in elderly women with urgency urinary incontinence.   "
64847|NCT02436876|"     This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively     to infected osteosynthesis sites for patients diagnosed with a fracture site infection     associated with orthopaedic hardware. Three quarters of the patients will receive MBN-101,     while the other one quarter will receive placebo.   "
64848|NCT02436863|"     The lesion located inside the spinal canal caused big trouble for clinical treatment.     Traditional laminectomy will destroy the biomechanics and influent the vertebral stability,     which might cause kyphosis or other deformity. So in some centers, neurosurgeries praised     laminoplasty to make the intactness of posterior column. They thought the laminoplasty can     maintain the vertebral stability, and meanwhile the range of motion won't change so much.     However, some other scholars thought laminoplasty had no helps for stability because of the     pseudarthrosis. They preferred screw and stick system for internal fixation. And we did meet     several patients after laminectomy suffered with spinal deformity. So we thought it is     necessary for investigating the benefit of patients from laminoplasty and internal fixation.   "
64849|NCT02436850|"     The purpose of the trial is to evaluate the effectiveness of moderate to large volume     thoracentesis (TC) in non-ventilated patients in Internal Medicine admitted due to, or suffer     from respiratory instability. This is a prospective, double-center, randomized clinical     trial. This is a stage 1 pilot trial aimed to provide better understanding on the study     population and study groups. This trial will comprise a total of 60 patients, 30 subjects on     the intervention group and an equal number on the control group. The results of this pilot     trial will be to design a larger trial and calculate a required sample size.   "
64851|NCT02436824|"     The objectives of this study are to examine the safety, tolerability, and efficacy of     repeated topical administration of AB001 topical patches for the treatment of chronic low     back pain.   "
64879|NCT02436460|"     This study is to establish the safety, determine if there is an improvement in steroid     refractory acute graft-vs-host disease (aGvHD) compared to historical cohorts, and determine     the changes of aGvHD-associated T-cell clones in patients with steroid-refractory aGVHD     following allogeneic hematopoietic cell transplantation administered AbGn-168H once weekly     for 4 weeks.   "
64852|NCT02436811|"     This is study aims to evaluate the retention of information on oral health and eating habits     in children under two years of age. A total of 180 pregnant women aged between twelve and     fifty years of age will be selected for this study. Before the randomization process, the     literacy in oral health score will be assessed through previously validated instrument     BREALD- 30. Participants will be randomly selected according to the value of BREALD-30,     categorized as adequate (≥18) and low (<18) in a specific intervention. Interventions occur     in written form through an educational brochure or standardized oral, both with information     about the feeding practices and oral health in children under two years. The control group     will be the implementation of an educational booklet on oral cancer. To evaluate the     association between variables pregnant women will respond to a semi-structured form with     questions regarding oral health and nutrition, in three different times: before the     intervention, 15 minutes after the intervention and 4 weeks after the intervention. Social     and economic and demographic data will be evaluated at baseline. The data will be     statistically analyzed by Student's t-tests and ANOVA paired, adopting a 5% significance     level. In the event of non-normality of the data, the corresponding non-parametric     statistical tests will be applied. This study has the hypothesis that the written     intervention presents best results in participants with high literacy and the standardized     oral with those with low literacy.   "
64853|NCT02436798|"     5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea     and vomiting. However, these medications also associated with potentially severe and     life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data     regarding the cardiac safety and inter-individual variability in cardiac effects of     ondansetron when used in vulnerable populations such as children and pregnant women are very     limited. The results of this study will enable better-informed therapeutic decision-making     regarding the use of ondansetron in children and pregnant women, with the overall goal to     improve the safety of these commonly used antiemetic medications. Furthermore, predictive     pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify     patients at risk of cardiac toxicity before the drug is administered.   "
64854|NCT02436785|"     Pain management is rated by patients with inflammatory arthritis as the highest priority in     their disease treatment. Past research showed that music therapy is associated with reduced     pain and depression. The purpose of this study is to better understand the effectiveness of     music therapy for people with inflammatory arthritis. Participants will be randomly assigned     to: 1) Music Therapy group facilitated by a music therapist, or 2) Music Listening group that     listens to a relaxation CD (compact disc). Standardized tests will determine if participating     in music therapy group helps reduce pain and depression, improve physical function and     confidence levels in applying self-management strategies.   "
64857|NCT02436746|"     Both Neurofibromatosis type 1 (NF1) and Tuberous Sclerosis Complex (TSC) are highly     heterogeneous diseases. Cognitive features seem to vary widely even between family members     carrying the same mutation. This phenotypic variability is not well understood, but is     generally assumed to be caused by modifier genes which regulate the affected pathways.     However, recent studies brought forward an alternative explanation for the phenotypic     variability. Post-mortem studies showed that second hit mutations causing loss of the second     ('healthy') allele are more widespread than previously believed. These loss of heterozygosity     (LOH) mutations cause bi-allelic loss of the disease-linked gene and are known to cause the     gross of somatic features in both diseases (like neurofibromas and hamartomas). Hence, it     could be the stochastic occurrence of second-hit mutations in the brain are the cause of the     variable cognitive phenotypes.      To investigate to what extent these LOH mutations in the brain contribute to the phenotype     and to what extent this variation is due to genetic modifiers factors is unknown. The     investigators therefore propose to elucidate this variability by comparing the correlation of     cognitive features of monozygotic twins with NF1 or TSC to healthy twins in the population.     If modifier genes are the cause of the variability of cognitive features in NF1 and TSC the     investigators expect that the variability in cognitive tests in monozygotic twins is the same     as monozygotic twins in the healthy population. However, if the variability is caused by the     occurrence of LOH mutations, the investigators expect to have a lower correlation in our     monozygotic patients compared to the healthy twins.   "
64858|NCT02436733|"     This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early     stage MPM will be randomized between Arm A: immediate P/D followed by three cycles of     chemotherapy (pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every     three weeks) Arm B: three cycles of chemotherapy (same regimen) followed by P/D, for     non-progressing patients   "
64872|NCT02436551|"     Evaluate prevalence and management of gestational diabetes in Tajikistan in two different     settings (one rural and one urban).   "
64873|NCT02436538|"     Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric     glycoprotein that belongs to the transforming growth factor-beta family. It is involved in     the regression of the Müllerian ducts during male fetal development. In the female, AMH is     solely produced by the granulosa cells of preantral and small antral follicles, and regulates     ovarian activity and follicular steroidogenesis   "
64874|NCT02436525|"     Microbial and periodontal changes associated with conventional versus self ligating brackets.      The aim of this study will be to compare microbial and periodontal changes associated with     conventional versus self ligating brackets.   "
64875|NCT02436512|"     The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of     GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation     predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health     Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically     necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo     an attempt to wean from parenteral PGI per standard of care.   "
64859|NCT02436720|"     The literature on outcome measures assessing upper limbs in Duchenne muscular dystrophy (DMD)     is quite scanty. While there have been considerable advances for ambulant DMD boys, no     prospective study has so far been devoted to outcome measures in non ambulant patients, with     increasing complaints from families and patients. This information appears to be highly     important not only for a better understanding of the progression of the disease but also for     possible enrollment of patients in future trials.      The aim of this project is to identify outcome measures for non ambulant patients in an     Italian population of DMD patients. At least 200 non ambulant DMD boys and adults will be     included in the study. All patients will be assessed using the newly developed Performance of     Upper limb (PUL) test. This measure will be used at baseline and 6 and 12 months after     baseline. This will allow to monitor possible changes over time and the rate of changes in     patients with different level of ability and age. As part of this study the investigators     will also correlate possible changes in upper limb function with other measures of care and     function such as the EK scale.      The investigators aim to assess the suitability of the individual measures in a large number     of patients, trying to establish whether whole scales or individual items appear to be     relevant across ages and level of abilities. The investigators also aim to assess the     suitability of the selected measures in a multicentric setting and the quantity of training     required The data collected will also be analysed using Rasch analysis in order to improve     the statistical properties of the measures used.   "
64860|NCT02436707|"     The purpose of this study is to find out what effects new combinations of treatment will have     this disease. In this clinical trial, the study treatment options currently are ibrutinib     plus R-GDP, or R-GDP alone.   "
64861|NCT02436694|"     Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and     sciatic nerve block improve analgesia postoperatively in patients submitted to total knee     arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the     local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.      Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid     consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side     effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and     falls).   "
64862|NCT02436681|"     Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived     from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an     indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will     serve to provide clinicians with high-quality clinical data in order to provide them with a     higher degree of confidence when selecting MIROMESH for hiatal hernia repair.   "
64863|NCT02436668|"     This is a phase 2/3 to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel     and gemcitabine for the first line treatment of patients with metastatic pancreatic     adenocarcinoma.   "
64864|NCT02436655|"     Whether to intervene in asymptomatic patients with severe aortic stenosis and normal left     ventricular ejection fraction remains controversial. The investigators therefore try to     compare clinical outcomes of elective aortic valve replacement to conventional treatment and     watchful waiting strategy in a prospective randomized trial.   "
64867|NCT02436616|"     The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively     investigate the cerebral electrical activity of infants with Apnea, Bradycardia and     Desaturation events. This project will also assess the feasibility of using the microEEG     device in the Neonatal Intensive Care Unit (NICU) setting and the feasibility of remote     centralized interpretation in this setting.   "
64868|NCT02436603|"     The purpose of this project is to examine whether a low cost, group-oriented integrative     medicine approach to irritable bowel syndrome improves participant outcomes. The intervention     will combine nutrition counseling on the low FODMAP diet (decreased grains and other     disaccharides) and mind-body training with follow-up health coaching.      These participants will be randomized to either a 4-week group-oriented treatment     intervention incorporating a low FODMAP (fermentable oligosaccharides, disaccharides,     monosaccharides and polyols) diet and mind-body therapies followed by an 8-week health     coaching follow-up period or a waitlist control group. At the end of the 12-week study     period, waitlist subjects will be offered the four-week nutrition and mind-body intervention.     Over the 12-week study period, we will examine and report on the impact of this treatment     intervention on IBS symptoms and quality of life in this population. The investigators will     collect data on IBS outcomes as well as on depression and stress.   "
64869|NCT02436590|"     The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA     joints associated with a reduction of inflammation and improved homeostasis of the     extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain,     reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint     structure.   "
64870|NCT02436577|"     This study will be an open-label, randomised, three-period, three-treatment, crossover study     in healthy Japanese male and female of non-childbearing potential subjects, performed at a     single study centre.      The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD)     tablets when administered with water and without water and ticagrelor immediate-release (IR)     tablets.   "
64871|NCT02436564|"     The primary objective is to develop an in vitro model of cancer for laboratory study using     liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic     and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the     investigators hope to compare molecular and cellular biology of cancer cells with normal     cells as well as potentially test the efficacy of current and future anti-cancer therapies.      Samples will be collected from tissue that has been resected as part of the treatment for a     patient diagnosed with liver, bile duct or pancreas cancer.   "
64880|NCT02436447|"     This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18     years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous     infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to     be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6     subjects.   "
64881|NCT02436434|"     Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field     and heat bursts at a temperature less than 42°C to neural tissue. In contrast with     conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many     studies have shown its benefits in pain relief for certain kinds of chronic pain conditions.     For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF     is difficult and complicated because the supplying nerve of joint is complex or small. Hence,     some authors perform intra-articular PRF on the chronic painful joint for example, knee     osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and     shoulder joint and the excellent long-term effects are reported.      The purpose of this study is to investigate the effect of intra-articular PRF in     osteoarthritis.   "
64882|NCT02436421|"     This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for     use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for     patients with uncontrolled blood pressure and one for patients with atrial fibrillation not     on anticoagulation.   "
64883|NCT02436408|"     Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial     structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat.      Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in     which the Hh signaling pathway appears to contribute to the development and maintenance of     tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for     treatment of metastatic and locally advanced BCCA. Recent reports have suggested that     vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is     eventually required      In order to assess the potential of vismodegib to improve the ophthalmic outcomes following     treatment for orbital and/or periocular BCCA, this study will follow patients with     globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with     vismodegib as standard of care.   "
64884|NCT02436395|"     Surgical site infections (SSIs) is one of the most common complications of upper abdominal     surgery. Previous studies found that type of surgical incision, emergency operation or not,     surgical duration, age of patient, body mass index, malignance duration, malnutrition,     complications (diabetes, shock, anemia et al) and drug (Long-term use of corticosteroids) are     closely associated with the incidence of SSIs. The general incidence rate of SSIs was about     5% to 40%, although using the preoperative skin disinfectant and other methods to prevent and     reduce the SSIs. And for the gastrointestinal surgery, due to the potential risk of     infection, SSIs is an important problem which cannot be ignored. On the other hand, gastric     cancer is one of the most common digestive system tumors, and gastrectomy is the primary     therapeutic options. Therefore, it is important to compare the whether the different liquid     (1% povidone-iodine solution or the 0.9% normal saline) wash the incision can influent the     incidence of the SSIs.   "
64885|NCT02436382|"     Neonatal hypothermia is associated with increased risk of mortality as well as multiple     morbidities. The investigators objective is to determine if an increase in ambient operative     room temperature decreases the rate of hypothermia. Operating room temperature will be     randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly     basis for a period of six months.   "
67185|NCT02406339|"     This study evaluates the effect of training with neuromuscular electrical stimulation (NMES)     associated with vascular occlusion of the lower limbs, for increased strength and hypertrophy     of the quadriceps muscle of professional basketball athletes.   "
64886|NCT02436369|"     The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids     to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel     randomized controlled trial the investigators recruited 70 diabetic patients and randomly     allocated to control and treatment groups. Participants in treatment group consumed 30 gr     flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily.     Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood     pressure, weight, waist circumference and body mass index were measured at the first and end     of the trial.   "
64887|NCT02436356|"     The goal of this study is to determine whether two new, non-X-ray techniques can discriminate     between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of     osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral     density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at     identifying individuals who are at risk of suffering a fracture. Yet, there is a growing     population of diabetics and elderly individuals prone to fractures. In effect, the     age-related and diabetes-related increase in fracture risk is independent of a person's aBMD.     These findings stress the urgency in developing diagnostic tools that can improve fracture     risk prediction so that patients can be treated with the appropriate anti-fracture therapies.   "
64888|NCT02436343|"     The aim of this work is to Assess serial changes in cardiovascular function in morbidly     obese pregnant females (BMI equal or higher than 30 kg/m2) as compared to normal lean     pregnant female controls.   "
64889|NCT02436330|"     Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted     weight management program in a randomized controlled trial (RCT). Primary objective: to     assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on     cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming     component on attendance and participation.   "
64890|NCT02436317|"     This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is     to evaluate the benefit of adding POC US to the management of inpatients admitted to the     internal ward with respiratory, cardiovascular or hemodynamic abnormalities.   "
64891|NCT02436304|"     The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to     tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).   "
64892|NCT02436291|"     Open label study to evaluate the efficacy of CURE-EX device in the treatment of     onychomycosis.   "
64893|NCT02436278|"     This study investigates whether usual walking speed, measured by the 4 metre gait speed test     (4MGS), and change in usual walking speed over 6 months predicts death and hospital     admissions in patients with Idiopathic Pulmonary Fibrosis.   "
64894|NCT02436265|"     Caudal injection of local anesthetic is a neuraxial technique routinely performed on young     children for postoperative analgesia after lower abdominal and lower extremity surgical     procedures. One of the major limitations of the use of single shot neuraxial injections for     this purpose is the limited duration of action of the injected local anesthetic. Adjuvant     medications, such as clonidine and epinephrine, have been added to the local anesthetic to     prolong the duration of the neuraxial block, with varying results. Dexamethasone is a     synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude     of indications, including the prolongation of local anesthetic based analgesia. It has been     shown that the administration of dexamethasone either intravenously or via perineural     injection can significantly increase the duration of analgesia derived from a local     anesthesia based peripheral nerve block. Literature also suggests that the effect of     dexamethasone is equivalent whether given intravenously or perineurally. Interest in     dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal     anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using     a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the pediatric population     outside of airway procedures, which may expose patients to dose related side effects of     dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective for analgesic     prolongation, but no direct study of low dose intravenous dexamethasone in combination with     caudal anesthesia has been performed.   "
64895|NCT02436252|"     This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for     whom no effective therapies currently exist.   "
64896|NCT02436239|"     The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone     for the treatment of MDD in pediatric outpatients (7-17 years).   "
64897|NCT02436226|"     The purpose of this study is to evaluate the effect of administration of low dose of human     chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation     in infertile women having CC resistant polycystic ovarian syndrome (PCOS).   "
64898|NCT02436213|"     Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the     lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This     study will examine the exercise capacity of PAVM patients using formal cardiopulmonary     exercise tests performed on a stationary bicycle.   "
64899|NCT02436200|"     This study will assess the benefit of a neuromuscular electrical stimulation device in     patients suffering from symptoms and effects of lower limb intermittent claudication.   "
64900|NCT02436187|"     The aim of the study is to quantify the excess mortality associated with non-adherence to     care for non ST-elevation myocardial infarction in England and Wales over the last decade.   "
64901|NCT02436174|"     Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment     of shivering has been based on a simple scale using descriptive words rather than actual     measurements. We believe that we can assess shivering more scientifically by using a novel     method to quantify arm movements during shivering.   "
64952|NCT02435641|"     The current study has the following objectives:        1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression,          PTSD, satisfaction with life and quality of life in both patients and caregivers, after          controlling for injury severity and impairment.        2. To determine factors associated with patient and caregiver satisfaction with medical          care at time 2 and time 3.      The investigators would thus be able to identify the best time point for intervention     delivery, intervention targets, and risk factors for chronic psychological distress.   "
64902|NCT02436161|"     OBJECTIVE: To evaluate the effectiveness of a multidisciplinary care management collaborative     program for high-risk patients with heart failure (HF) who are admitted at hospital, based on     the 6 components of the Chronic Care Model PROMIC, in terms of reduction of a Combined     event rate (readmissions / cardiac events / death / emergency department visits) and other     variables, the feasibility of the program, the improvement on quality of life related to     health and functional capacity of the PROMIC patients compared with control patients in usual     care.      DESIGN: A quasi-experimental, prospective one year follow-up study. SETTING AND SUBJECTS:     Primary Health care Centres of Interior County in Bizkaia and of Araba County in Araba,     Galdakao Hospital, Santa Marina Hospital and University hospital os Araba in the Basque     Country. Will be captured as a minimum intervention group of 125 patients admitted for HF in     New York Heart Association (NYHA) functional status II-III-IV from previous mentioned     hospitals. Another 125 patients from different primary health care centers, will be the     control group.      INTERVENTION: The intervention to be applied will be PROMIC, control patients will receive     usual care MEASUREMENTS: The mean outcome measure will be the time free of events from the     time of inclusion to the first event (readmission / cardiac events / death / emergency     visits). Secondary endpoints will be the quality of life related to health (MLFHQ and SF-12),     functional capacity (6-Minute Walk Test), structural changes in cardiac structure     (natriuretic peptide levels), adherence to drug treatment (Morinsky-Green), the cost of the     program, the usefulness and acceptability of PROMIC by professionals and patients. Predictor     variables also will be collected such as sex, age, education level, co-morbidity, social risk     level, dependency etc.      STATISTICAL ANALYSIS: Analysis was performed by intention to treat. Survival curves will     done. A model of Cox proportional hazards will be built.   "
64903|NCT02436148|"     The present study assesses the reliability and validity of the Finnish version of Prothesis     Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for     the present study from the Helsinki and Uusimaa Hospital District and the Central Finland     Health Care District.   "
64904|NCT02436135|"     This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of     idelalisib in adults receiving ruxolitinib as therapy for intermediate to high risk primary     myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis     (post-PV MF or post-ET MF) with progressive or relapsed disease.   "
64905|NCT02436122|"     The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa)     outcome remains controversial. Thus, the investigators aim to examine the association of     preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).      The investigators will prospectively collect the relevant data including preoperative HbA1c     in 264 patients of PCa patients undergoing RP. The associations between clinical variables     and risk of adverse pathological features and disease recurrence will be tested using a     multivariate logistic regression and multiple Cox-proportional hazards model, respectively.   "
64906|NCT02436109|"     Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes     spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is     placed in the lower back and local anesthetic is injected to freeze the body. Normally,     before the needle is placed in a patients' back, the anesthesiologist will feel between their     back bones with his/her fingers to find the right spot for the needle. This study will be     evaluating if the distance from the skin to the appropriate spinal space measured with a     novel 3D Ultrasound will equal the actual depth of the needle insertion.   "
65051|NCT02434211|"     The main objective this project is the development of a measurement tool. This consists of     construct and validate a questionnaire to conduct a quantitative assessment of knowledge and     individual conceptions of cancer enrolled in CM1 and CM2 (9-11 years).   "
64907|NCT02436096|"     The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of     Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202     study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial     effects upon pain, sleep and other FM symptomatology.      The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets,     taken daily at bedtime over 12 weeks to treat fibromyalgia.   "
64908|NCT02436083|"     The purpose of this study is to monitor and compare peri-operative problems and outcomes of     reconstructive surgery with microvascular free flaps in the head and neck region between     groups of patients treated with perioperative antibiotics and a group of patients without     antibiotics.   "
64909|NCT02436070|"     BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency     Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's     Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds billions of     dollars annually when including direct cost and lost productivity. Many of these visits and     resultant costs are avoidable. Patients with well-controlled asthma do not typically exhibit     these patterns, while patients with poorly controlled asthma show patterns of increased     utilization of healthcare resources and lower quality of life. Evidence suggests that a text     message reminder and educational program might positively influence pediatric asthma care     practices.      RESEARCH QUESTION Does a targeted ED based text message intervention program improve     outpatient follow-up and routine preventive care in pediatric asthma patients?      METHODS Study subjects will be block randomized based on age and insurance group. The     experimental group will receive text messages with guidance towards follow-up care with their     PCP and the importance of the flu vaccine for children with asthma. The control group will     receive a series of educational self-care and health based text messages unrelated to asthma     or the flu vaccine. Some self-report of behaviors will be captured via text message response.      ANALYSIS Primary outcomes for the educational versus targeted text message groups will be     compared use Chi-square tests. Additional adjustments may be applied for missing data or if,     despite randomization, there is substantial imbalance between group in key covariates (eg     race/ethnicity, insurance type or asthma severity.)   "
64948|NCT02435693|"     Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule      Objectives:-        1. To evaluate Pharmaceutical care program in Type2 diabetics.        2. To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with          Type-2 Diabetes Mellitus.        3. To study the prevalence of Type2 diabetics cases in Dhule.        4. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2          diabetics.        5. To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.        6. To study the impacts of Pharmaceutical care program on glycemic control in patients with          Type-2 Diabetes Mellitus.        7. To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital          Dhule.        8. To compare the efficiency of Pharmaceutical care program and drug in patients with          Type-2 Diabetes Mellitus.        9. To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.       10. To increase the patient compliance and positive attitude of patients towards the          diabetes disease by counseling.   "
64910|NCT02436057|"     Through a four-year grant awarded to the University of California at Los Angeles in 2009, Dr.     Brennan Spiegel served as a principal investigator (PI) for a project to develop and     initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National     Institutes of Health's (NIH's) Patient Reported Outcomes Measurement Information System     (PROMIS). By the end of the grant period in July 2013, the project team had successfully     developed and initially validated eight scales measuring the most common GI symptoms.      Afterwards, Dr. Spiegel's PROMIS team joined forces with the UCLA Computing Technology     Research Laboratory (CTRL) and the University of Michigan Center for Healthcare Communication     Research to develop the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) algorithm     which is delivered via My GI Health, an open-‐source Internet based patient-provider portal     (P3) designed to enhance the delivery of GI health care (www.MyGIHealth.org). Through My GI     Health and AEGIS, patients are able to complete PROMIS GI symptom measures and provide     additional information about their GI symptoms and histories from computers, tablets or smart     phones without the constraints of physical locale. This information is condensed into a GI     PROMIS scores report and initial GI history that patients' providers can review prior to or     concurrent with seeing the patient. The report, which can be incorporated into the electronic     health record (EHR), helps busy clinicians to quickly understand the patient's complaints,     document their symptoms and GI history, and leaves more time for conversation with the     patient.      Beyond focusing their interaction, My GI Health also supports both the clinician and patient     with an individualized educational prescription which guides the patient through a library     of multi‐media educational materials on GI symptoms, conditions, and treatments also     contained within the website. The prescription is initially created by the website based on     each patient's unique GI PROMIS fingerprint, and can be modified by the provider based on     their interaction with the patient. The clinician and patient can also access the     PROMIS-tailored education in the exam room to jointly review pertinent materials, including     animations of normal and abnormal GI functions, further reinforcing the patients' educational     experiences around the PROMIS symptoms.      The aim of this current study is to validate the use of GI PROMIS in clinical practice by     conducting a pragmatic clinical trial (PCT) comparing delivery of GI PROMIS on a novel     e--platform vs. usual care.   "
64911|NCT02436044|"     A large proportion of Asian patients with HCC present with locally advanced or metastatic     disease,at which point they are ineligible for curative treatments.Oxaliplatin plus     fluorouracil/leucovorin intravenous infusion was proved effective in prolonging     progression-free survival(PFS) than doxorubicin as palliative chemotherapy in patients with     advanced HCC from Asia. Besides, hepatic arterial infusion chemotherapy (HAIC）is a widely     used method for primary or metastasis liver tumor with high local tumor response. To our     knowledge, there have not been any prospective studies to assess the safety and effecacy of     HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced     HCC.Thus,the purpose of this phase 2 study was to assess the safety and effecacy of HAIC     using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.   "
64912|NCT02436031|"     Obstructive sleep apnea (OSA) is common and has major health implications but treatment     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared     to normal participants. Until recently, the search for medicines to activate pharyngeal     muscles in sleeping humans has been discouraging. However, exciting new animal research has     shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle     activity to waking levels. In this protocol the investigators will test the effect of     desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)     on upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA     patients.   "
64913|NCT02436018|"     Low pulse oximetry is the most common adverse events during sedation for upper     gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present     study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL     JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be     evaluated.   "
64914|NCT02434965|"     The purpose of this study is to investigate the safety and effectiveness of autologous human     placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates     with severe hypoxic-ischemic encephalopathy.   "
64927|NCT02435966|"     The investigators study the efficacy of a combination of dry needling plus manual therapy     against sham dry needling plus manual therapy in the treatment of chronic neck pain. The     investigators identify the most active trigger point in the upper trapezius and levator     scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days     after the first intervention. The primary outcome is the Visual Analogue Scale of Pain.     Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and     range of motion.   "
64915|NCT02434952|"     In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less     effective. The investigators can help to try to prevent the spread of this resistant malaria     by adding a drug that will make it more difficult for the mosquito to drink up the malaria in     people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot develop     in the mosquito so it will not be able to inject malaria back into people when it bites. The     drug the investigators will use is called primaquine.      Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red     cells need enzymes to work properly and weak red cells have low amounts of an enzyme called     glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria     with primaquine will be safe for the red cells. To do this study, the investigators need to     know if a subject has low G6PD or not.   "
64916|NCT02434939|"     This clinical trial will inform of the role of Low dose ketamine in the acute treatment of     severe painful sickle cell crisis in children in a day-case sickle cell centre. The primary     aim is to determine whether Low dose ketamine is non inferior to morphine in the management     of acute painful sickle cell crises. The specific objectives will be to determine the maximal     change in NRS pain score following administration of ketamine and to examine the safety     profile of ketamine compared to morphine in this population.      The investigators hypothesize that low dose ketamine will result in similar effective pain     control as morphine alone and will not be associated with an increase in adverse events.   "
64949|NCT02435680|"     To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and     gemcitabine (carbo/gem) in advanced TNBC patients   "
64950|NCT02435667|"     The objective of this proposal is to determine the effect of resistance exercise training on     locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF     patients with preserved ejection fraction (HFpEF).   "
64953|NCT02435628|"     This is a prospective study through the NF clinic at Massachusetts General Hospital that will     examine the relationship between psychosocial factors, health literacy, and satisfaction with     the medical visit in adults with NF1, NF2, and Schwannomatosis. A total of 89 participants     will be enrolled in the study.   "
64917|NCT02434926|"     Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several     congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation     of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital     diaphragmatic hernia etc. The technique involves an introduction of small-caliber instruments     into the amniotic cavity under ultrasound guidance. This procedure can be successfully done     under either general anesthesia, regional anesthesia or local anesthesia with sedation. Each     technique has both advantages and drawbacks.      Several complications related to anesthetic after fetoscopic surgery can occur. For instance,     pulmonary edema which is caused by intravenous fluid loading, irrigation fluid absorption or     fluid flow through myometrium venous channel. Besides, maternal hypotension intraoperatively     can arise from spinal anesthesia.      The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the     tertiary care institute (Siriraj hospital) and incidence of complications which may relate to     different anesthetic techniques.   "
64918|NCT02434913|"     This surgery involves the use of a finger joint replacement device for treatment of patients     with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who     expect to place their hands in heavy loading situations, or patients needing revision of a     failed implant placed in the PIP joint. A joint replacement surgery is an operation where the     arthritic joint is removed and a metal and plastic joint is inserted to replace the natural     joint. The surgery is expected to last about 2 hours. The procedure is done in the operating     room and requires general anesthesia or an axillary block. (General anesthesia affects the     entire body and is accompanied by a loss of consciousness. An axillary block results in     anesthesia of the hand and forearm only. A tourniquet is applied to the arm to prevent     bleeding during the surgery.)   "
64919|NCT02434900|"     The Vitamin D and Angiogenic Marker Study 1:      Vitamin D and angiogenic markers in early pregnancy. Epidemiology and associations to     early-pregnancy miscarriage   "
64920|NCT02434887|"     The purpose of this study is to verify the effectiveness of the investigational product     through Subjective Assessment and answered by volunteers.   "
64921|NCT02434874|"     The purpose of this pivotal study is to illustrate the safety and effectiveness of the     StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge     incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92     subjects will receive a StimGuard SNS System.   "
64922|NCT02434861|"     The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and     its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP     substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy     adult population.   "
64923|NCT02434848|"     Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in     HIV-infected individuals, including more rapid progression to cirrhosis and associated     complications such as hepatocellular carcinoma. For this reason, as well as the shared routes     of transmission between the two viruses, UK and International guidance recommends that all     HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately,     response rates in this population can be as low as 17.5 - 40% to standard vaccination     courses. To improve this response, strategies such as the use of double dose of standard     vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders,     although there is currently limited evidence for this approach. An alternative strategy is to     use vaccines with novel adjuvants such as Fendrix and observational clinical data in the     Investigators HIV cohort suggests that response rates can be as high as 81% of individuals     achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to     previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher     than Engerix B and controlled trials are required to confirm whether this approach is     warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit     better responses would be valuable in optimising future vaccine strategies in this     population.      The Investigators propose to conduct a randomised, open label, active-controlled pilot study     comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV     vaccine courses, which will provide the necessary data to design and power a larger     multicentre randomised controlled trial. Outcome measures will include the proportion of     individuals seroconverting with HBsAb levels >100 following each vaccination course, the     magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and     the durability of the HBsAb response at 1 year following the end of vaccination.   "
64924|NCT02434835|"     The purpose of this study is to evaluate the absorption, metabolism and excretion following a     single oral dose of [14C]KWA-0711 to healthy male subjects.   "
64925|NCT02435992|"     The purpose of this study is to determine whether RPC1063 is effective in the treatment of     Ulcerative Colitis (UC).   "
64926|NCT02435979|"     This study will be a randomized controlled trial comparing proximal strengthening vs.     traditional hand therapy for patients with wrist pain. Patients will attend 2 hand therapy     sessions per week for 4 weeks. Change in patient function and pain as measured by the patient     rated wrist evaluation will be the primary outcome of interest   "
65052|NCT02434198|"     The primary aim of this study is to investigate the incidence of falling in a cohort of     patients with chronic obstructive pulmonary disease (COPD) referred to a pulmonary     rehabilitation program and to verify the risk factors. The secondary aim is to verify whether     available balance assessment tools are feasible in clinical practice and which tools and     values can best predict falls in people with COPD.   "
64928|NCT02435953|"     The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter     arterial chemoembolization (TACE) alone.The combination of TACE with RFA has also reported to     be an effective treatment for HCC. Some prospective studies have shown TACE combined RFA to     have better efficacy than any of them alone for early stage HCC (single tuomor ≤5 cm).     However, to the investigators' knowledge, there have not been any prospective studies to     assess whether TACE combined sequentially with RFA is more effective than TACE alone for the     treatment of intermediate-stage HCC. The investigators hypothesized that the combination of     TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of     this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone     for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined     as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions,     largest tumor size ≤7 cm; ECOG-PS 0;Child-pugh A or B;no tumor thrombus or extrahepatic     metastases.   "
64990|NCT02435147|"     The purpose of this study is to validate the long-term benefit of denosumab for osteoporosis     treatment in a real-world clinical practice setting. We hypothesize that continued therapy     (36+months) with denosumab will increase both trabecular bone score (TBS) and femur strength     index (FSI) and reduce fracture and other bone health risks among post-menopausal women with     osteoporosis.   "
64929|NCT02435940|"     My Retina Tracker® is a registry for people affected by an inherited retinal degenerative     disease. It is a patient-initiated registry accessible via a secure on-line portal at     www.MyRetinaTracker.org. Affected individuals and genetically related, unaffected, family     members who create entries are guided to create a profile that captures the participants'     perspective on their disease and its progress; family history; genetic testing results;     preventive measures; and interest in participation in research studies. The participants may     also choose to ask their clinician to add clinical measurements and results at each clinical     visit. Participants are urged to update the information regularly to create longitudinal     records of their disease, from their own perspective, and their clinical progress. The     overall goals are: to better understand the heterogeneity of the inherited retinal     degenerative diseases; to understand the prevalence of the different diseases and gene     mutations; to assist in the establishment of genotype-phenotype relationships; to help     understand the natural history of the diseases; to help accelerate research and development     of clinical trials for treatments; and to provide a mechanism that facilitates more rapid     recruitment for research studies and clinical trials.   "
64930|NCT02435927|"     This is a Phase I, open-label, dose escalation study of ASLAN001 given in combination with     CAPOX or mFolfox6, in patients with metastatic solid tumours, whom are suitable to receive     CAPOX or mFolfox6, or with tumours that have dysregulated EGFR or HER2 signaling.   "
64931|NCT02435914|"     This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of     3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle     in patients with dry eye disease.   "
64932|NCT02435901|"     This study will evaluate the use of reduced intensity conditioning regimen in patients with     high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard     immunosuppressive medications, followed by a routine stem cell transplant in order to assess     whether or not it is as effective as myeloablative high dose chemotherapy and transplant.   "
64933|NCT02435888|"     Predictive equations are the main clinical tool for determining resting energy expenditure     (REE). Thus, it is important to investigate the accuracy and agreement of these equations in     different populations and context of diseases. The purpose of this study is to investigate     the accuracy and agreement of predictive equations of REE in overweight women with polycystic     ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means of indirect     calorimetry and predicted (pREE) through ten equations basing on the anthropometric     parameters (Harris & Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU including weight and     height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones, Müeller, De Luis and     Lazzer).   "
64934|NCT02435875|"     Impaired baroreflex sensitivity (BRS) is a marker of autonomous dysfunction, which may play     an important role in the long-term development of hypertension. Perioperative patients with     hypertension is rapidly growing in all populations worldwide. However, no study has reported     the values of BRS in this cohort. The aim of this study was to estimate the value of BRS for     hypertension in a surgery cohort.   "
64935|NCT02435862|"     A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed     to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with     Non-Proliferative Diabetic Retinopathy.   "
64936|NCT02435849|"     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and     safety of CTL019 in pediatric patients with r/r B-cell ALL.   "
64937|NCT02435836|"     The primary objective of the study was to determine the safety of aripiprazole administered     long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects with     chronic or first episode of schizophrenia. Information on the continued efficacy of     aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until     aripiprazole was otherwise available through marketed means and/or reimbursed).   "
64938|NCT02435823|"     This is a prospective multi-center, single arm, non-randomized study. It is designed to     evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation     intracranial aneurysms.   "
64946|NCT02435719|"     Ministry of Health through the National Medical Stores has supplied alcohol-based handgels to     the different health facilities in Uganda for the health care providers to use during     clinical care. However, constant stock-outs and or limited supplies remains the main     constraint faced by the hospitals. Thus the handgels are generally used by a few of the     senior health care providers.      The promotion of bedside, antiseptic handrubs largely contributes to the increase in     compliance and sustained improvement of hand hygiene compliance reduces Health care acquired     infections (HCAIs), but it is not yet established how cost- effective the intervention is in     a a rural Ugandan hospital where funds are severely rationed and, which serves over 4 million     people in over 15 districts in Uganda. An evaluation of an intervention's cost-effectiveness     is a crucial factor in whether the government will be prepared to fund the intervention and     sustain it.      This WardGel study thus aims to assess the cost-benefit of providing hand gel for all health     care workers in Mbale Regional Referral Hospital.   "
64947|NCT02435706|"     A randomized controlled trial of 12-month duration to compare gingival margin location,     buccal horizontal ridge dimensions, and interproximal crestal bone levels following two     surgical approaches for immediate placement of implants in the esthetic zone: one involving     flap elevation and another using a flapless protocol.   "
64951|NCT02435654|"     In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7     years old and onset of illness before 17 years old, and all EOS patients will receive a     8-week systematic olanzepine titration treatment and a battery of assessments of treatment     effect and safety. Blood olanzepine plasma concentration will be tested regularly and     genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase     Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes     genotyping technology. The aim of the study is to explore the predictive factors on     olanzepine treatment response in EOS, which can guide the individualized treatment and     improve the cure rate of EOS in clinical setting.   "
65000|NCT02435017|"     Overall study design is to review National Health and Nutrition Examination Survey (NHANES)     data 1999-2008 for nutrition risk according to kidney function. Substudies will be performed     to review the association of nutrients and overall dietary intake compared to biomarkers     available in NHANES during this period.   "
64939|NCT02435810|"     Background:      - Inflammation is how the body reacts to infection or injury. . Infections or inflammation in     the brain and nerves can be serious. There aren t always good tests to detect this.     Researchers want to learn more about how diseases affect the brain and nerves to develop     better tests and treatments.      Objective:      - To learn more about how inflammation and infections hurt the brain and nervous system.      Eligibility:      - People at least 2 years old with a diagnosis or suspected diagnosis of nervous system     infection or inflammation.      Design:        -  For some participants, a clinician outside of NIH will collect blood, tissue, and other          samples. These will be sent to NIH and analyzed.        -  Other participants will have several visits to NIH. Children may not have all these          tests.        -  Participants will have:        -  Medical history.        -  Physical and neurological exam.        -  Blood and urine samples collected.        -  Saliva collected. They will chew on a piece of sterile cotton for one minute.        -  Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong          magnetic field. Participants will lie on a table that slides in and out of the cylinder.          Participants will get a contrast agent through an intravenous (IV) catheter during the          MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein.        -  Lumbar puncture. Skin will be numbed and a needle will be inserted into the space          between the bones in the back. Fluid will be removed.        -  Some participants may have optional study procedures. These may include eye tests,          memory and thinking testing, tests with electrodes on the head, or skin biopsy.   "
64940|NCT02435797|"     To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI)     reduces reperfusion injury.   "
64941|NCT02435784|"     The Two-Way Communication Checklist (2-COM) is a communication tool developed by van Os et     al. (2002). It aims to provide an opportunity for patients to voice their needs and problem     to minimize the discrepancy and miscommunication between patient and professional carer. In     this randomized controlled trial, the investigators aim to examine whether using 2-COM     checklist would lead to improvement in first episode psychosis patient's overall     satisfaction, change in treatment option in clinicians and consultation time.   "
64942|NCT02435771|"     Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES     data collection there was a near doubling of patients with vitamin D deficiency in 10 years.     Vitamin D deficiency is associated with several adverse outcomes such as increased fractures,     certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The     increasing prevalence of vitamin D deficiency has been attributed to the increasing     prevalence of obesity. Several studies have shown that obese patients have lower 25-OH     vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more     vitamin D compared to nonobese patients. The most commonly prescribed medication to replete     vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been     published to evaluate a standard protocol in the treatment of vitamin D insufficiency in     adults.   "
64943|NCT02435758|"     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle     will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic     nerve preservation) surgery played a role in decreasing incidence of urinary and sexual     function disorder. However, 32%-44% patients still suffered from urinary and sexual function     disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).      In the early stage of work, the investigators performed preservation of Denovilliers' fascia     in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal     cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME     significantly decreased incidence of urinary and sexual function disorder. In order to     further confirm the early work, the investigators design a multicenter randomized controlled     clinical trial to compare differences in urinary and sexual function protection and long-term     outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.   "
64944|NCT02435745|"     Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited     connective tissue disorders characterized by joint hypermobility, skin hyperextensibility,     and tissue fragility. EDS features such as genetically related cartilage defects,     craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to     cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires     that EDS patients might be more frequently affected by OSA and sleep disturbances than the     general population. However, the actual prevalence of OSA in patients with EDS is unknown.      Aortic root dilation and dissection are common complications of EDS and little is known about     the underlying risk factors. Preliminary evidence suggests a link with OSA but this has not     yet been investigated.      The primary objective of this study is to assess the prevalence of OSA in EDS-patients (100)     compared to a matched control group (100). The secondary objective of this pioneer study is     to assess whether there is a relationship between OSA severity and aortic     diame-ter/craniofacial abnormalities in EDS patients.   "
64945|NCT02435732|"     Limiting brain death-induced organ injury through a systemic anti- inflammatory medical     management should allow for improvement in the quality of transplanted organs, and as a     result, clinical improvement in post-transplant outcomes represented by a decrease in the     incidence of delayed graft function (DGF) after transplantation.      The specifc aim is to evaluate the effect of C1INH (CINRYZE) as a donor pre-treatment     strategy to decrease systemic inflammation and decrease the incidence of DGF in Expanded     Criteria Donors (ECD), currently identified as donors with Kidney Donor Profile Index (KDPI)     over 85%.   "
64970|NCT02435407|"     There is a paucity of research evaluating the effectiveness of a multidisciplinary approach     in an outpatient clinic setting in the management of feeding problems in children diagnosed     with ASD. Current behavioural interventions geared to address this problem can be labour     intensive and costly. The SOS approach for managing feeding problems in children has been     adopted internationally. Thus establishing its effectiveness will be useful in providing     evidenced based interventions for feeding difficulties in ASD.   "
65001|NCT02435004|"     A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the     ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in     patients with small fiber neuropathy (SFN).   "
64954|NCT02435615|"     Dengue is the most common viral illness spread by mosquitos. It is important to diagnose     dengue to prompt adequate therapy and initiate local mosquito control. Easy to use point of     care tests are needed to improve dengue diagnosis. Oral fluid collection may be a simple,     non-invasive way to diagnose dengue in the community. However, it is currently unknown if     oral fluid is an accurate way to diagnose dengue and if the use of a specialized oral fluid     collector could help to improve dengue diagnosis. In this study, the investigators will     analyze the oral fluid of suspected dengue patients compared to serum samples for dengue     diagnosis. From this information the investigators will be able to determine if oral fluid is     a convenient way to diagnose dengue and if the oral fluid collector aids in improving     diagnosis.   "
64955|NCT02435602|"     This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol     chromoendoscopy in the early detection of esophageal cancer in patients with prior head and     neck cancers.   "
64956|NCT02435589|"     The purpose of this study is to investigate the effectiveness of a systematic approach to     pain assessment in the critically ill patients' outcome The investigators hypothesize that,     patients who will undergo systematic pain assessment and they will have their results     notified to physicians and nurses, will demonstrate favorable effects on pain intensity, more     efficient use of sedatives and analgesics, duration of mechanical ventilation, length of ICU     stay, mortality, adverse events and complications, in relation to patients who will receive     standard care alone. Moreover it is expected that they will demonstrate altered levels of     plasma neuropeptides and biochemical markers in peripheral blood.   "
64957|NCT02435576|"     The primary and general objective of the clinical introduction of the SFP as the current     standard of care is to improve the quality of radiotherapy for head and neck cancer patients     by reducing radiation-induced side effects without hampering treatment efficacy in terms of     locoregional tumour control and overall survival and to systematically evaluate the     beneficial effect of newly introduced radiation technology for this particular group of     patients. The clinical introduction of the SFP will allow for a systematic and broad scale     quality improvement cycle for head and neck cancer patients treated with radiotherapy. In     fact, this methodology can be considered a kind of quality circle for the clinical     introduction of new radiation techniques, aiming at continuous efforts for further     improvement.   "
64971|NCT02435394|"     Asthma, one of the most common pediatric illnesses, is optimally managed according to     National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in     primary care. This project is to develop and test the effects of using a module for guideline     based care in the Child Health and Development Interactive System (CHADIS) online system by     prompting and incorporating patient symptom/control and adherence data from standard     questionnaires to inform visits and providing automated patient specific education and Asthma     Action Plans in individual Care Portals.   "
64972|NCT02435381|"     The purpose of this study is to determine the effects of treatment with carisbamate compared     to treatment with placebo, on alcohol-induced stimulant and subjective effects in     non-treatment seeking alcohol-dependent human volunteers.   "
64973|NCT02435368|"     To determine the mechanisms and significances of synergistic effects of mycophenolic acid and     LPS on IL-1β secretion by mononuclear   "
65065|NCT02434029|"     The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide     effervescent tablets versus placebo for the induction of clinico-pathological remission in     patients with acute eosinophilic esophagitis.   "
64958|NCT02435563|"     Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to     clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks.     Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active     metabolite. Because of the remarkable progress in HIV therapies the number of older age     patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV     therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is     contraindicated in these patients because of the expected interaction and bleeding risk. A     lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of     ritonavir has been already demonstrated. Therefore, administration of a lower dose of     ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this     pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in     case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as     administered alone using a physiologically-based pharmacokinetic (PBPK) model.      As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will     be created based on available in vitro and in vivo parameters in healthy volunteers.      An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers     at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first     session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the     volunteers and obtained pharmacokinetic data will be fitted into the model for optimization.     Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg     ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time     profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize     the magnitude of this interaction will be calculated. This new dose will be co-administered     with ritonavir in the same volunteers during the second session of the clinical trial. The     purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered     alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg     ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both     sessions of the clinical trial using two specific platelet function tests: the     VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK     profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A     and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as     probe substrates.      The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to     broaden the application field of ticagrelor, especially in HIV patients. Since PK models are     often created after clinical observations, the prospective aspect of this study is of     particular value as the model will be first created and then applied to an unknown clinical     scenario.   "
64959|NCT02435550|"     The purpose of this study is to use genomic information from individual patients to create     simulation avatars that will be used to predict novel drug combinations with therapeutic     potential.   "
64960|NCT02435537|"     The current study investigated the effect of adding dexmedetomidine to intrathecal morphine     for postoperative analgesia in cancer patients undergoing major abdominal surgery.   "
64961|NCT02435524|"     The time between birth and age 24 months provides a unique opportunity to impact the     long-term health and development of children through improved infant and young child feeding     practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25%     in infants younger than six months.      The purpose of this study is to evaluate whether the Alive & Thrive intervention package,     consisting of interpersonal counselling and community mobilisation activities, can increase     the exclusive breastfeeding rate among infants younger than six months to at least 50% using     a cluster randomised design.   "
65002|NCT02434991|"     This study is being done to assess the esophageal muscle (swallowing tube) in patients with     and without achalasia to further understand and help direct the treatment for patients with     achalasia.   "
65003|NCT02434978|"     The present study is a randomized controlled trial (RCT) that examines if the outcome of     peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.   "
64962|NCT02435511|"     CommunityRx is a health information technology-based innovation that, starting with the     patient-health care provider encounter, facilitates self-care coordination for patients,     caregivers, and providers. The CommunityRx database interfaces with electronic medical     records to provide patients with a HealtheRx. A HealtheRx is a list of community-based     self-care resources tailored to the patients health needs (e.g., a person with diabetes     receives information about podiatrists, nutrition classes, and other resources need to manage     diabetes). CommunityRx aims to measurably improve health and health care while reducing     health care costs especially in underserved health care settings. Specifically, the proposed     research aims to 1) evaluate the impact of CommunityRx on health care utilization, cost,     health, and patient-centered outcomes for program participants compared to controls; 2)     examine the flow and spread of information to and through primary agents including: program     participants, community health information experts, healthcare providers, and community-based     service providers (businesses and organizations providing self-care resources); and 3) build     and use an agent-based model to test the distributed impact, including economic effects, of     CommunityRx system adoption on the demonstration area and predict performance over time by     conducting experiments that vary assumptions about agent, environment, and population-level     characteristics.   "
64963|NCT02435498|"     This study's objectives are as follows:      1. To evaluate the utility of a website to provide information and guidance about pain     management in children 2. To educate parents about the pathophysiology of pain, proper use of     analgesic medications and signs of pain in children 3. To reduce the functional impact of     pain in children following treatment for fracture 4. To endow parents with confidence to     manage their child's pain at home 5. To dispel misconceptions about the use and safety of     analgesics in children 6. To increase awareness of complications of fractures such as     compartment syndrome   "
64964|NCT02435485|"     Patients with degenerative lumbar spondylolisthesis usually are present with low back pain,     muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even     urine or stool incontinence. There are very few research on the effectiveness of core spine     stabilization exercise, balance training, and the balance effect while wearing lumbar corset     in these patients.      Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability     with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic     spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance     training and balance effect of the wearing of lumbar corset in patients with degenerative     lumbar spondylolisthesis .   "
64965|NCT02435472|"     The AS RCT study is a randomized controlled trial of 16-weeks aerobic exercise (home-based     walking) vs. usual care among 150 men with prostate cancer on active surveillance.   "
64966|NCT02435459|"     The aim of this research is to compare the clinical outcome of amalgam restorations placed in     conjunction with three different lining protocols, each of which represents a different     therapeutic concept.   "
64967|NCT02435446|"     Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative     assessment of otosclerosis.      The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and,     therefore, could replace the CT.      In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis     and/or the pre-operative assessment of an otosclerosis.      The results of the CBCT will be compared to those of the CT scan.   "
64968|NCT02435433|"     The purpose of this study is to evaluate the safety and efficacy of ramucirumab in     participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein.     Participants will be randomized to ramucirumab or placebo in a 2:1 ratio.   "
65008|NCT02434770|"     The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV)     manufactured by Beijing TiantanBio has a similar immunogenicity profile to a WHO     pre-qualified bOPV.   "
64974|NCT02435355|"     Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for     moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the     treatment appears to be a key factor to improving health status of these patients.      Methods: The investigators conducted a multicenter, prospective, randomized, controlled,     parallel group trial of standard support completed or not within 3 months of coaching     sessions for newly diagnosed SAHS patients starting CPAP therapy. The coaching session     consisted of 5 sessions of telephone-based counseling by competent staff. The primary outcome     was the proportion of patients using CPAP more than 3 hours per night for 4 months; the     secondary outcome was mean hours of CPAP usage in the 2 groups.   "
64975|NCT02435342|"     The primary purpose of this study is to examine safety outcomes in active plaque psoriasis     patients after systemic administration of dalazatide. Clinical outcome measures will also be     assessed.   "
64976|NCT02435329|"     This study is part of a research project for a University MD Program. This is an     observational study aimed at comparing the differences in bone metabolism and     microcirculation in patients with type 2 diabetes mellitus (with and without diabetic     neuropathy and Charcot foot) with healthy subjects.      Diabetes is gradually becoming a global epidemic along with its associated complications.     Diabetes can affect several systems in our body particularly the eyes, nerves and the     kidneys. The damaging effects occur at the level of the small blood vessels     (microcirculation) that supply these vital structures. Normally, the inner lining of these     blood vessels (endothelium) plays a very important role in maintaining adequate blood flow.     The endothelium releases a chemical substance called nitric oxide, which relaxes these small     blood vessels thereby ensuring sufficient blood supply to these key structures. Nitric oxide     also prevents blockage of these vessels. Any form of metabolic stress like hyperglycaemia     (raised blood sugar as seen in diabetes) can cause abnormal changes in the normal behaviour     of the endothelium (endothelial dysfunction). Therefore hyperglycaemia promotes endothelial     dysfunction by lowering nitric oxide levels, which may lead to diabetic complications like     diabetic retinopathy (eye damage), nephropathy (kidney damage) or neuropathy (nerve damage).      In addition, patients with diabetes also suffer from osteoporosis (thinning of bones).     Osteoporosis is a bone disorder characterised by a reduction in bone mineral content leading     to an increased risk of developing fractures. The increased risk of fractures in patients     with type 2 diabetes is attributed to poor bone quality resulting from the harmful effects of     high blood glucose. Studies have also shown that nitric oxide has a bone protective effect as     demonstrated by its ability to prevent bone fragmentation and improve bone strength.      Study of markers of endothelial function and bone metabolism will facilitate a better     understanding about the origin of diabetic complications. This will aid in the development of     novel therapeutic agents that target the harmful triggers in diabetes and eventually may     prevent and retard the onset of the debilitating diabetic complications.   "
64977|NCT02435316|"     This is a prospective, randomized controlled, crossover trial comparing the effectiveness one     two curricular designs to teaching peripheral blood smears to residents.   "
64978|NCT02435303|"     The purpose of this study is to determine whether Sildenafil is effective in the treatment of     sustained pulmonary artery hypertension after corrected mitral valve disease.   "
64979|NCT02435290|"     It is a cross-sectional study examining a random sample of in- and out-patients, with proven     malignant disease receiving chemotherapy, over a period of 6 months from the start of the     study who visit the Oncology department, Ain Shams University Teaching Hospitals. The effect     of some risk factors on the prescribing error will be studied; these risk factors include the     following: Tumor type ,Cancer stage ,type of comorbid illness ,type of medication , type of     anti-cancer treatment , number of abnormal lab data ,type of abnormal lab data , the number     of drugs in the treatment regimen , the number of side effects after chemotherapy     administration, the age of patient ,the dosing frequency of anticancer ,the route of     administration .      Summary statistics are performed to describe patient characteristics , frequency, types and     classification of medication error; and frequency with which Medication errors occur.      Logistic regression will be applied to the collected data to perform a predictive relation     between the risk factors which may be (categorical, continuous, or discrete) and the     prescribing errors which are (categorical).   "
64980|NCT02435277|"     Study NS-0100-01E is an extension of Study NS-01-0100 designed to assess safety and longer     term effect (i.e., additional 8 weeks) of various fixed-dose leucine and metformin     combinations (NS-0100) versus standard metformin monotherapy on glycemic control in subjects     with type 2 diabetes using HbA1c as the primary endpoint.   "
64981|NCT02435264|"     Recent national statistics revealed that the prevalence of lifestyle related diseases is     increasing in Singapore. Much of this disease burden can be prevented using lifestyle     strategies. A large proportion of Singaporeans consume foods prepared by outside vendors.     These foods are typically high in refined-grains and saturated fat, and choices for healthier     foods like brown-rice often do not exist. The Healthier Dining Program managed by the Health     Promotion Board of Singapore, seeks to assess if increasing the availability of healthier     food options increases consumer consumption of these foods. The investigators aim to evaluate     this program implemented on the National University of Singapore campus. A major output of     this evaluation will be the assessment of the barriers and enablers to programme     implementation which will provide guidance for the widespread implementation of the     programme. Additionally this evaluation can lead to detailed recommendations on policies and     programmes relevant to non-home food environments. This is important as successful     interventions have the potential of improving the eating behaviors of a vast majority of the     population.   "
64982|NCT02435251|"     The purpose of this research is to study changes in weight, body mass index, and percentage     of fat following orthopaedic knee or shoulder surgery.   "
64983|NCT02435238|"     Non interventional study collecting patient reported outcomes. The study aims to assess the     disease burden of chronic urticaria patients and to record the therapies used in daily     clinical practice in the UK and the impact they have on the quality of life and work     productivity of individual patients.   "
64984|NCT02435225|"     The investigators propose to study 30 adolescents with bipolar disorder, not otherwise     specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI     (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare     data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy     controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen     (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will     take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a     natural progression of past research, while extending the investigators' expertise to include     advanced FC analyses and mindfulness based interventions in youth with mood dysregulation.     The investigators will also integrate trainees into the imaging and therapy components of     this study, furthering our mission of mentoring the next generation of innovative researchers     who will push the field forward.   "
64985|NCT02435212|"     This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment     compliance and change in serum ferritin of a deferasirox granule formulation and a     deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment     with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to     demonstrate the effect of improved compliance on iron burden.      Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior     iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core     phase where patients will be randomized to a 48 week treatment period to either Deferasirox     DT or granules, and an optional extension phase where all patients will receive the granules     up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or     express the wish to continue in the optional extension phase on granules, will be offered     this possibility until there is local access to the new formulation (granules or FCT) or up     to 5 years, whichever occurs first.   "
64986|NCT02435199|"     The study consists of two periods, the Screening Period (~3 weeks) and Treatment Period (12     weeks).      Eligibility for the study will be determined by Screening tests, physical examination/medical     history, and fulfilment of eligibility criteria including assessment of pain completed during     the Screening Period. Potential participants will be required to provide written informed     consent prior to any study-specific Screening procedures being performed.      Following Screening assessments, patients will be randomized to receive either EMA401 300 mg     BID or placebo.      Patient study visits during the Treatment Period are at the end of baseline/randomization     visit, and end of Weeks 3, 6, 9, and 12, for assessments.   "
64987|NCT02435186|"     The study objective is to investigate the efficacy and safety of p53 combined with     chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer,     Fallopian Tube Cancer, and Primary Peritoneal Cancer.   "
64988|NCT02435173|"     This study is designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with     genetically activated PI3Kδ, i.e., patients with APDS/PASLI. The study consists of two parts.     Part I is the open label part designed to establish the safety and pharmacokinetics of CDZ173     in the target population, as well as to select the optimal dose to be tested in part II. Part     II is designed to assess efficacy and safety of CDZ173 in this population.   "
64989|NCT02435160|"     The aim of our study is to investigate the efficacy and mechanism in fecal microbiota     transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC)     patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT)     treatment,the safety and efficacy of FMT will be observed.   "
64991|NCT02435134|"     Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility     of the hip. The assessment is typically done manually (manual testing), which induces large     variability in the results between and within testers. An initial version of an examination     chair (EC1) was recently developed with the aim to minimize the variability of testing     results for HIRROM assessments. A new version of the examination chair (EC2) has been     implemented in order to individualize the testing protocol and will be validated in this     study.   "
64992|NCT02435121|"     Primary Objective:      To determine objective response rate (ORR).      Secondary Objectives:      To assess duration of response (DR), progression free survival (PFS) and overall survival     (OS).      To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical     utility of fluorescence in situ hybridization (FISH) assay in selection of patients with     mesenchymal-epithelial hybridization (MET) gene amplification.      To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.   "
64993|NCT02435108|"     This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.   "
64994|NCT02435095|"     Continuation of antipsychotic drug treatment for at least 12 months after remission of the     first psychotic episode represents the gold clinical standard, and it is recommended by all     international treatment guidelines. Numerous studies have shown that the risk of relapse is     significantly increased, if drug treatment is terminated prematurely. However, only a     minority of patients achieve functional remission, even if they fully comply with treatment.     Long-term adverse effects of the currently available drugs, specifically brain grey matter     loss and development of supersensitivity psychosis, might outweigh their benefits. Thus, the     current standard of long-term maintenance antipsychotic treatment, which has the primary goal     of relapse prevention, has to be questioned. Here the investigators hypothesise that     intermittent antipsychotic treatment (targeted exclusively at positive symptoms) initiated     after the first psychotic episode is associated with less regional and global brain (grey     matter) volume loss over a period of twelve months than continuous antipsychotic treatment.     Furthermore, the investigators hypothesise that this targeted treatment approach is     associated with better functional outcome (fewer negative symptoms, better cognitive     performance, better quality of life) than continuous antipsychotic treatment,although the     latter is initially associated with fewer relapses.   "
64995|NCT02435082|"     The objective of this patient registry is to collect and analyze physiological data     associated with baseline and brain injury identified in standard clinical practice (Normal     Values, Recovery Curves, Correlation between Symptoms and Other Tests, NCI Index), and to     assess health economics.   "
65049|NCT02434237|"     Task-oriented repetitive movement can improve movement performance in patients with     neurological or orthopedic lesions. The application of robotics can serve to assist, enhance,     evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy     is used in neurological rehabilitation for patients with paralyzed upper extremities due to     lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury.     The goal of the therapy is to recover motor function, improve movement coordination, learn     new motion strategies (trick movements), and/or prevent secondary complications such as     muscle atrophy, osteoporosis, and spasticity.   "
65083|NCT02433795|"     This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in     patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).   "
64996|NCT02435069|"     There is a surgical procedure to help children with intractable fecal incontinence gain     continence for stool through construction of a tube that connects the abdominal wall to the     colon near or through the appendix. This tube allows easy administration of enema solution     into the first part of the colon. Putting enema solution through that tube into the colon is     called an antegrade continence enema or ACE and has been shown to work well in helping some     but not all children prevent stool accidents. The purpose of this study is to compare a large     volume ACE flush using a salt water solution called normal saline with a small volume ACE     flush using liquid glycerin. The aims of this study are to: 1) find the most effective dose     and flush frequency of each solution; 2) compare which solution given at the best dose takes     the least amount of time to clear the colon of stool, has the least side effects, and is the     most effective in preventing stool accidents; and 3) to determine if administration of either     of the ACE flushing solution affects colon health and the bacteria in the colon.   "
64997|NCT02435056|"     Appropriate delivery of quality healthcare requires constant monitoring of the patient during     follow up, particularly in the presence of chronic diseases. This approach can be further     improved if leading edge tools supporting diagnosis, as well as prediction, identification     and monitoring of adverse events are available. COMOESTAS aims to develop an innovative     Information Communications Technology (ICT) system that allows patients with a chronic     condition to receive continuous and personalized treatment. The whole system is based on an     advanced, all in one Alerting and Decision Support System that follows patients from the     diagnosis and supports the physician in managing the therapy, controlling relevant events     impacting on patient safety and activating specific procedures if selected thresholds are     exceeded. In the frame of chronic neurological disorders, Medication Overuse Headache (MOH)     is a common condition and a major cause of disability. MOH is curable, but its outcome is     hampered by a high risk of relapse. It is, therefore, a perfect example of a disorder that     can benefit from an ICT-assisted approach developing innovative systems and services for     monitoring chronic conditions. COMOESTAS goals will be achieved by improving and integrating     the traditional paper headache diaries and calendars into an innovative ICT tool taking into     account the complex issues that accompany this peculiar form of headache, which will make the     patient a key node in the entire process.   "
64998|NCT02435043|"     The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on     to standard management, could influence post-stroke fatigue (primary outcome), depression,     work ability or functional outcome (secondary outcomes), compared to controls.   "
64999|NCT02435030|"     This is a prospective non-therapeutic observational study in NP-C patients. The aim is to     characterize the individual patient disease progression profile through the historical and 6     months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of     life data.      Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of     the study.   "
65005|NCT02434809|"     The first purpose of this study is to test a new computer program that reduces the blurring     in the cone-beam CT scan and helps the doctor to better locate the tumor. The investigators     want to find out what effects, good and/or bad, that this has on the patient and the way we     treat the cancer in the lungs.      The second purpose of this study is to test how well this computer program tracks markers in     the images, compared to using radio signals to follow the markers.   "
65006|NCT02434796|"     Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has     detrimental effects on mental and physical health including an increased risk of HIV     infection. The investigators will use a cluster randomized control study design to conduct a     preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable     attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine     villages will be randomly assigned into one of three study arms, each comprised of 150     partnered women and their co-resident male partners. Women in the comparison arm are     currently exposed to World Education's savings and lending group intervention (known as     LIMCA), in which they receive training on business skills, literacy, child nutrition and     health, child protection, intimate partner violence (IPV) and HIV prevention. Women in     Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in     male peer group workshops that explore gender norms, IPV and HIV prevention issues. In     Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and     participate in community dialogues with community leaders to explore similar topics as the     male peer groups. Our hypothesis is that study participants in Arm 2 will report improved     gender equitable attitudes and lower intolerance of intimate partner violence than     participants in Arm 1 and participants in the control group. Data will be collected at     baseline and endline using a structured questionnaire with questions from three validated     instruments that measure gender equitable attitudes and attitudes about IPV.   "
65007|NCT02434783|"     Current evidence cannot explain the clinical features of peripheral arterial disease only     from the principle of reduced blood flow. Explanations have therefore in addition been linked     to mitochondrial dysfunction of skeletal muscles.      This study will elucidate whether there is a relation between clinical variables of the     different levels of arterial insufficiency in peripheral arterial disease and mitochondrial     respiratory capacity.   "
65009|NCT02434757|"     This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in     patients with active rheumatoid arthritis (RA) who have had an inadequate response to disease     modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. An in adequate     response is defined as having ≥ 6 tender joints, ≥ 6 swollen joints, plus C-Reactive Protein     (CRP) levels and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times the upper limit of     normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone. This will be a 20     week, prospective, multicenter, open-label study conducted at 3-4 university/medical centers     and private practice settings in the US. A total of 20 eligible patients will be enrolled and     other standard RA therapeutic agents, such as Methotrexate, DMARDs, non-steroidal     anti-inflammatory drugs (NSAIDs), pain medications and others will not be discontinued. The     primary endpoint will be the percentage of patients with reduction of ≥1.2 points of the     Disease Activity Score in 28 joints (DAS-28) score.   "
65010|NCT02434744|"     This study will compare the safety, tolerability and efficacy of the combination of KD026 and     metformin compared to placebo and metformin on improving glycemic control in patients with     type 2 diabetes mellitus.   "
65011|NCT02434731|"     Needle procedures are the most common and important source of pain and distress in children     in the health care setting. Children with intellectual disability from any cause experience     pain more frequently than healthy children. They often require venipuncture or IV cannulation     for diagnostic or therapeutic procedures. Pain in this population is often unrecognised     because these patients are frequently unable to self-report their pain. Now it's possible to     measure pain in children with intellectual disability with specific pain scales, like     NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).      The efficacy of a device combining vibration and cold for pain relief during venipuncture or     IV cannulation has been recently reported in children. The device's actions are based on the     Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons     to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in     this kind of patients in emergency department. To date, there is no study that validated     Buzzy device for pain relief in children with intellectual disability.      The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and     vibration), in reducing the pain during venipuncture or IV cannulation, in children with     intellectual disability.   "
65012|NCT02434718|"     The primary objective of the study is to evaluate the safety and tolerability of single and     multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to     moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To     evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous     (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of     Aducanumab on immunogenicity.   "
65013|NCT02434705|"     The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic     esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it     starts an chronic allergy-based inflammation. This will be analyzed with the esophageal     biopsies and the mucosal impedance probe.   "
65014|NCT02434692|"     The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in     patients with POAG and indicated cataract surgery.   "
65028|NCT02434510|"     The primary objective of this study is to compare the efficacy of adding 0.05% chlorhexidine     gluconate to the splash basin in reducing bacterial growth from splash basins at the end of a     total joint replacement procedure.      Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at     the end of elective total joint arthroplasty cases.      Null Hypothesis: There will be no difference in bacterial growth from the splash basin at the     end of the case despite the addition of an antimicrobial solution.   "
65029|NCT02434497|"     The purpose of the study is to evaluate the safety of Rosuvastatin in Children and     Adolescents with Homozygous Familial Hypercholesterolemia.   "
65015|NCT02434679|"     Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are     increasing. Among the actions to control resistance, one is an interesting lead: to prevent     the emergence of resistant bacteria by limiting possibilities for bacteria to acquire     resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few     data on the dynamic of acquisition over time. Among the genetic components that disseminate     resistance genes, resistance integrons (RI) play a major role in the acquisition and     dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the     newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the     first days of life. It thus appears to be an appropriate model to study the dynamic of     resistance acquisition. This project intends to follow the NB of neonatology over time in     order to study the dynamic of the digestive acquisition of RI and MRB   "
65016|NCT02434666|"     This is a long-term-safety roll-over extension study for a Phase II Study (Protocol     CPC-001-07).   "
65017|NCT02434653|"     Anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms     versus screening of women at increased risk for post-partum anemia.   "
65018|NCT02434640|"     The objective of this trial is to investigate the safety and tolerability of BAY1128688 and     to determine the concentration of this substance in blood after repeated administration by     the oral route. The investigational substance will be administered in tablet form to healthy     women.   "
65019|NCT02434627|"     The investigators' previous work in males with Becker Muscular Dystrophy shows that     functional sympatholysis is restored by acute inorganic nitrate supplementation. This was     translated from work using the mdx mouse model of dystrophinopathy. Recent work has shown     that there is a frank improvement in grip strength when mdx mice are treated with an     inorganic Nitric Oxide (NO) donor. The purpose of this study is to determine if chronic     treatment with an inorganic NO donor can benefit patients with muscular dystrophy beyond     blood flow regulation.   "
65020|NCT02434614|"     Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was     superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal     carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without     sequential chemotherapy has become the standard care for locoregionally advanced NPC.     However, most of these evidences of standard treatment for locoregionally advanced NPC were     based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated     radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved     the treatment outcomes of patients with NPC, especially the local control rate. Currently,     more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and     reported that concurrent chemotherapy failed to improve survival rates for patients with     locoregionally advanced disease, but increased the severity of acute toxicities. People     started to reconsider the role of CCRT. Therefore, we propose this randomized phase III     non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in     locoregionally advanced NPC during IMRT era.   "
65021|NCT02434601|"     The surface of non-carious cervical lesions (LCNC) is a challenge to adhesive systems, it     presents a dentin layer sclera hypermineralized, presence of bacteria and lack of mechanical     retention, so this study aimed to evaluate the influence of different surface treatments on     LCNC through a randomized clinical trial. Patients with LCNC were referred to the study and     selected according to the inclusion criteria, such as the presence of at least 3 LCNC. Three     different types of surface treatment were carried out in LCNC: control group, 15 seconds of     etching dentin; Group I, acid etching of dentin in 30 seconds; and group II, cavity     prophylaxis with ultrasound for 30 seconds. The remaining steps of the adhesive and     restorative procedure was the same for all groups, following the material manufacturer's     recommendations. Evaluations of restorations will be carried out in periods of one week     (baseline), six months, one year, two years and three years as of tooth sensitivity,     integrity and color change. Data will be analyzed by McNemar and chi-square test.   "
65023|NCT02434575|"     This registry study enables us to collect data on the treatment of LUTS using prostate artery     embolisation (PAE), and other surgical methods to answer the following questions posed by     NICE in 2013:        -  Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?        -  How does PAE compare with conventional surgical treatments? This will primarily be a          surgical procedure called transurethral resection of the prostate (TURP) (see below).        -  Which patients would most benefit from PAE over the other treatment options?   "
65024|NCT02434562|"     This is a prospective biobank set up to collect serum from patients with disorders associated     with changes in androgens, estrogens or sex hormone-binding globulin (SHBG), before and/or     after treatment.   "
65025|NCT02434549|"     The purpose of this double-blinded, placebo-controlled study is to test if treatment with     Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic     cerebral palsy.   "
65026|NCT02434536|"     Objectives: To estimate the rate of appropriate hospital admissions , and of discharge to     home episodes that would have been appropriate admissions to the hospital, on patients with     exacerbations of their COPD by using appropriateness explicit criteria developed with the     RAND appropriateness methodology. To evaluate the validity of those criteria by looking at     their correlation with morbid-mortality, use of medications and health resources. To identify     the variability in the appropriateness admission/discharge among the different centres     participating on the study.      Methodology: Prospective observational cohort study. 1. The investigators will apply the     previously developed explicit criteria to a sample of COPD exacerbations presented in each of     the Emergency Department of each participating hospital (16 centres). 2. The investigators     will evaluate if there is variability among centres by comparing their appropriateness rates.     3. To study the validity of the criteria, on those admitted the investigators will collect     information on their evolution (length of stay, need of medication, quality of life),     complications, vital status during their admission until discharge, and up to 2 months after     the visit to the Emergency Department the vital status, complications, readmissions and     quality of life. On those discharged to home from the Emergency Department, the investigators     will check the presence of complications, vital status, readmissions and quality of life.     People trained will collect all the needed information, in the Emergency Department, during     their admission, or by personal interview to all discharged to home and to all at 2 months     after the visit to the Emergency Department.   "
65033|NCT02434445|"     This study investigated the use of novel plasma and urinary biomarkers to predicte the     development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers     investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA,     plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced     cirrhotic patients who have or have not developed hepatorenal syndrome and compared between     the two groups. These biomarkers will also be correlated with the occurence of hepatorenal     syndrome.   "
67412|NCT02403362|"     The purpose of this study is to evaluate the safety,efficacy， pharmacodynamics (PD), and     pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic     kidney disease (CKD) Who are not on dialysis   "
65034|NCT02434432|"     Background: Music therapy has been recommended as an adjuvant therapy for both preterm     infants and mothers throughout their stay in the Neonatal Intensive Care Unit (NICU), and has     been shown to have some beneficial effects, although conclusive evidence remains lacking.      Objectives: To study the usefulness of two forms of music, as well as no music, on pain and     physiological and behavioral parameters of preterm infants during a heel stick procedure for     obtaining blood in the Neonatal Intensive Care Unit (NICU).      Hypotheses: Infants hearing music chosen by their mothers will have less pain and optimal     behavioral and physiologic responses as compared to infants who hear the lullaby or no music.      Methods: An analytical observational study with a randomized cross-over design will be     utilized.      Inclusion will be stable infants born between 28 to 36 weeks of gestation, with normal     hearing. Neonatal Physiologic responses [heart rate (HR), oxygen saturation, (02 sat) and     respiratory rate(RR)] and Behavioral States will be recorded before and after the heel stick     procedure. Maternal age, education, and pregnancy complications will be also be documented.     Pain responses will be recorded using the Neonatal Pain, Agitation and Sedation Scale     (NPASS).      Ethical considerations: The study imposes minimal risk on infants. One potential risk is that     the infant may become agitated while listening to music, especially if it is time for     feeding. Based on previous research, infants tend to calm down while listening to music.     However, in the infants who may be hungry or fussy, music exacerbate their agitation. To     prevent this from occurring the investigators will not perform the heel stick close to     feeding time and the investigators will be vigilantly timing and monitoring the infant's     agitation. Because music has been shown to calm infants and stop them from crying, the     benefits outweigh this risk.      The heel stick is performed routinely on infants (often 3-6 times a day). The investigators     will not perform any additional heel sticks for this study, but will rather intervene during     one of the scheduled heel stick procedures.   "
65035|NCT02434419|"     A prospective randomized clinical trial of patients undergoing bariatric surgery.      Patients were randomly assigned into 3 groups: those patients undergoing percutaneous     electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1),     those patients doing the specific training alone (Group 2) and those patients without any     specific treatment (Group 3).      The assigned treatment began 15 days after surgery and was maintained during 12 weeks.   "
65036|NCT02434406|"     This study examines the feasibility and acceptability of a web-based intervention program for     women with anxiety after childbirth, potential anxiety reduction after the intervention and     determines the feasibility of the study design (randomized controlled design) and recruitment     for the intervention in this population to inform the protocol (including effect size and     study power) for a randomized controlled trial.   "
65037|NCT02434393|"     The purpose of this research study is to characterize the mechanisms contributing to     cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD).      This is a non-randomized, observational, non-treatment study. One hundred and twenty (120)     subjects who meet criteria for Major Depression or LLD will be enrolled for a period of 30     months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for     comparison.      Depression history, symptom severity and health information will be collected at the initial     psychiatric visit to determine eligibility. A 3 Tesla (3T) Magnetic resonance imaging (MRI)     scan and florbetapir (18F-AV-45) amyloid imaging will be conducted at the ADNI clinic site     visits. Collection of plasma and serum for biomarkers, clinical assessments and cognitive     assessments will be conducted at two time points. Blood samples will also be collected for     genetic analysis.   "
65038|NCT02434380|"     The optimal vitamin D replacement dose during pregnancy remains undefined. Therefore, the aim     of this study is to test the hypothesis that a daily equivalent dose of vitamin D of 3,000     IU/day is needed for Middle Eastern women, to optimize maternal vitamin D level and neonatal     musculoskeletal parameters, specifically knee-heel length at birth and bone mineral content     at one month of age.   "
65039|NCT02434367|"     This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the     Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to     usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery.      Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women     in both arms will complete a number of surveys including questionnaires on fatigue, pain,     depression, sleep, and social support. In addition, a blood sample will be collected prior     to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of     inflammatory biomarkers, and their potential association with exercise and fatigue.   "
65040|NCT02434354|"     The main purpose of this trial is to evaluate the safety, tolerability and adverse event     profile of pembrolizumab in subjects who have high risk melanoma before and after their     standard of care surgical resection, and to collect tumor tissue from subjects before and     after receipt of pembrolizumab to look at how the experimental drug interacts with tumor     tissue. Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete     resection and then a year of adjuvant pembrolizumab   "
65041|NCT02434341|"     15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo     polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep     features within the groups   "
65042|NCT02434328|"     The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT)     injection to aflibercept solution for IVT injection in subjects with untreated active     choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the     study eye. This study will be conducted in the following countries: Austria, Belgium,     Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy,     Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Sweden,     Switzerland, Taiwan, Turkey, and the United Kingdom.   "
65043|NCT02434315|"     The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro     wear as measured by time in range.   "
65044|NCT02434302|"     This is a study to ascertain the number of children with moyamoya in the UK, their presenting     features, clinical course and outcomes.   "
65045|NCT02434289|"     The purpose of this pilot study is to investigate the feasibility and potential impact of a     combined resistance exercise and increased protein intake intervention in (frail) elderly, in     a real-life setting.   "
65053|NCT02434185|"     The bilateral deficit phenomenon (BLD) is defined as an inability of the neuromuscular system     to generate maximal force when two homonymous limb operate simultaneously (bilateral     contraction) with respect to the force developed when both limbs acts separately (unilateral     contraction). From an applied perspective, movement patterns of bilateral homonymous limb are     often developed during activities of day living, e.g. rising from a chair or opening a jar.     The BLD can be considered an intrinsic property of the human neuromuscular system but could     be enough important to constitute a performance-limiting factor for postmenopausal women that     involves a degenerative loss of muscular strength. Therefore, a specific analysis of this     phenomenon and its relation with activities of daily living, such as climbing a step and     rising from a chair, is crucial for detecting variables of neuromuscular performance and     develop strategies to minimize the loss of strength.   "
65054|NCT02434172|"     The study will determine if the initiation of a 'screen and treat' program for cryptococcal     disease among HIV positive individuals decreases morbidity and mortality among individuals     with CD4 count < 100 cells/mm3. The study will screen individuals who are asymptomatic for CM     and are either ART naïve or ART experienced with CD4 count < 100 cells/mm3.      The introduction of an cheap, easy to use point of care diagnostic test the lateral flow     assay will facilitate rapid diagnosis of cryptococcal disease in resource limited settings.     The investigators will determine the efficacy of the lateral flow assay in identifying latent     and asymptomatic cryptococcal disease. The investigators will determine the efficacy of the     test in detecting disease in readily available body fluids such as urine and whole blood     obtained via finger-stick method. The investigators will also determine the cost     effectiveness of a screen and treat approach for cryptococcal disease in Zimbabwe.      The investigators also wish to understand why some individuals with low CD4 counts reactivate     cryptococcal disease and screen positive for cryptococcal antigen (CrAg) while others with     similar levels of immunocompromised do not.   "
65055|NCT02434159|"     The purpose of this study is to determine if detailed scanning of the heart before     biventricular device insertion will improve outcomes for heart failure patients.   "
65056|NCT02434146|"     This phase I/II trial studies the safety of topical phenylephrine solution and to see how     well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients     receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution     may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and     total body radiation prior to undergoing a bone marrow transplant.   "
65057|NCT02434133|"     The investigators proposed study is the first of its kind. The investigators will measure     measles, mumps, rubella, tetanus, diphtheria and pertussis antibodies in patients on the     current IBD treatment modalities and compare the vaccine antibody concentrations and     correlate them with time since immunization.   "
65058|NCT02434120|"     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid     structures or vascular structures. These masses can be tumors, benign or malignant, or     pseudotumor, mainly represented by specific or non-specific orbital inflammation.      Pathology is of considerable importance for the diagnosis and the treatment of those masses.     However, biopsy or surgical resection of the orbital masses is sometimes difficult and     dangerous outside expert centers.      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,     thus avoid in some cases a biopsy, would be a major contribution for the patients.      For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one     (type C) being related to malignant tumors.      In this study, the investigators will try to see if extrapolation of those data to orbiltal     tumors is feasible.   "
65059|NCT02434107|"     Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma     patients carrying a reasonable risk for metastases. In numerous studies the prognostic role     of micro metastases in the sentinel node (SN) was described. However, the prognostic value of     a complete lymph node dissection in patients with a positive SN is still unclear.      This study was planned to analyse the survival outcome of patients with a positive SN     receiving complete lymphadenectomy versus watchful waiting.   "
65060|NCT02434094|"     An e-learning training program is to prepare people with diabetes and their physicians on the     use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).   "
65061|NCT02434081|"     The aim of the study is to investigate the tolerability (how severe the side effects are) and     the efficacy (how well the treatment works) when nivolumab is added to the current standard     treatment (chemotherapy and radiotherapy) given to patients with advanced NSCLC.   "
65062|NCT02434068|"     Residual fragments of urinary calculi after flexible ureteroscopy (URF) can cause symptoms     and additional surgeries. The assessment of residual fragments by imaging is not     standardized. Computed tomography (CT) is the best way for evaluation of urinary stones,     however, ionizing radiation from CT is deleterious. The aim of this study is to define which     patients may avoid CT for evaluation of residual fragments after URF. 115 patients with > 18     years old undergoing URF for kidney stone < 20 mm or < 15 mm in the lower calyx diagnosed by     CT will be studied. The clinical evaluation of patients will be held by the same urologist in     pre-operative consultation, 7 days after the procedure, 30 days after the procedure and 100     days after the procedure. The assessment of residual fragments will be made through TC,     ultrasound and Kidney-bladder-ureter KUB 90 days after the procedure. The image methods for     residual fragments assessment will be compared by Cochran Test and prediction of parameters     to avoid CT will be made by multiple logistic regression, using IPSS 16.0, with significant     level of 5%.   "
65063|NCT02434055|"     Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during     angiographic procedures.      Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast     delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during     angiography (coronary or peripheral) and a concomitant system to precisely measure contrast     volume delivered to the patient. This will be a first in man prospective observational study     of the accuracy of this system to quantify contract volume used during clinically indicated     angiography in the cardiac catheterization laboratory.   "
65064|NCT02434042|"     This project aims to study the benefits of probiotics namely Bifidobacterium longum BB536 in     prevention of acute diarrhea and/or respiratory-related illnesses, which are found common     among children in Malaysia aged from 2 to 6 years.   "
65066|NCT02434016|"     Background: Mechanical ventilation is a life saving intervention in patients with acute     respiratory failure, for instance, due to infection or trauma. The main goals of mechanical     ventilation are to improve oxygenation and decrease the load imposed on the respiratory     muscles. Unfortunately, mechanical ventilation comes with adverse events including disuse     atrophy and weakness of the respiratory muscles. The diaphragm is the main muscle for     inspiration and therefore this clinical entity is commonly referred to as ventilator-induced     diaphragm dysfunction (VIDD). Several studies have shown that inspiratory muscle weakness is     associated with adverse outcomes, including prolonged duration of mechanical ventilation.     Inactivity or disuse is a recognized risk factor for the development of VIDD: disuse may     result from excessive unloading of the diaphragm by the ventilator. Therefore, clinicians aim     to limit the risk of VIDD by using ventilator modes that allow patients to perform at least     part of the total work of breathing when deemed clinically appropriate. However, even when     these so-called assisted modes for ventilation are used, excessive unloading of the diaphragm     may occur; without using technology that allows monitoring of diaphragm function, the     clinician is often uncertain as to whether this muscle is indeed actively working. Continuous     recording of the electrical activity of the diaphragm (EAdi) is used to monitor diaphragm     muscle activity in ICU patients. Furthermore, sonographic measurements of diaphragm thickness     allows for an easy quantification of diaphragmatic activity (thickening fraction) as well as     providing a potentially useful mechanism for studying diaphragm injury and function during     mechanical ventilation.      Aim: To assess the duration of diaphragm muscle inactivity in patients admitted to the ICU     using EAdi monitoring and to assess the correlation between diaphragm thicknening fraction,     as measured by ultrasound, and electrical activity, as measured by EAdi.      Hypothesis: Diaphragm muscle inactivity frequently occurs in the early phase of ICU admission     Design: Observational pilot study in ventilated adult ICU patients admitted to the ICU at St     Michael's Hospital. The investigators aim to enroll 75 patients.      Primary outcome: Time from catheter positioning to first EAdi (> 5 uV last at least 5     minutes)   "
65067|NCT02434003|"     Scoliosis is a three-dimensional deformity affecting the orientation and position of the     spine. Locally, the shape of the vertebra is also affected. The most common form is     adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young     adolescent females. AIS can either be treated using a brace and in some cases necessitate     surgical correction to prevent progressive deformity. Risk factors for progression include     female gender, curve magnitude and location, skeletal maturity and growth velocity. However,     these risk factors have been shown to be inconsistent in predicting curve progression. Over     the past 6 years, the investigators have developed a predictive model of the final Cobb angle     in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195     patients that were enrolled upon their initial visit and followed until maturity. This     predictive model has a determination coefficient of 0.702. The proposed new study aims at     refining and testing the external validity of this model in a larger cohort. The next step     towards using the new model in the clinical setting is to redesign the model and to     externally validate the model by measuring the agreement between the new method and the     traditional Cobb angle at maturity in a larger multicenter study. The objective of this study     is to characterize the risk of scoliosis progression based on local three-dimensional     vertebral and pelvic measurements present on initial evaluation. Three-dimensional     reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose     radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These     calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral     disks at each level as well as the geometry of the pelvis. A series of local and regional     parameters will then be calculated from these 3D reconstructions. Correlation analysis will     help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation     or pelvic geometry can be used as early predictors of curve progression in AIS.      Identifying a new 3D measure of scoliosis associated with rapid curve progression could help     predict which curves need early treatment to prevent further progression. The ultimate goal     of this research project will be to validate this new predictive model and finally transfer     this new predictive tool in the hands of clinicians treating AIS.   "
65068|NCT02433990|"     This research study is to determine the risk factors for acquired heart disease, in adults     with congenital heart disease. This knowledge is important to develop and target ways to     prevent or delay the onset of acquired heart disease in adults with congenital heart disease.   "
65069|NCT02433977|"     This study will examine the hypothesis that in obese asthmatics with metabolic syndrome;     treatment with NOx + CLA is well tolerated, safe and will increase eNO while reducing airway     oxidative stress. Allied with this, the investigators will define whether supplementing with     this bioactive mediator modifies the airway microbiome, and reduces airway inflammation.   "
65070|NCT02433964|"     The purpose of this study is to evaluate the therapeutic effects of the LED (627 +/- 10 nm)     with respect to the localized pain and local swelling of ankle sprains in the initial phase.   "
65071|NCT02433951|"     In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients     undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only).     Exercise tolerance is compared between groups.   "
65072|NCT02433938|"     Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the     enhancement of the recovery of bowel function and in shortening the hospital stay.   "
65073|NCT02433925|"     Inflammation and oxidative stress are common findings in patients with Chronic Kidney Disease     (CKD) undergoing conservative treatment, in addition to being associated with atherosclerotic     process, are related also to the progression of CKD. In this regard, resveratrol, a phenolic     compound with recognized antioxidant and anti-inflammatory properties, can play an important     role in the control of metabolic disorders associated with CKD, since it can modulate the     mechanisms involved in inflammation and oxidative stress cycle. Resveratrol is capable of     promoting the activation of the transcription-related factor-2 nuclear factor erythroid     factor 2 (Nrf2) , a nuclear factor with anti-inflammatory properties, and SIRT-1, a protein     also associated with the reduction of inflammation. These two factors, in their turn, are     able to inhibit / antagonize the activity of the nuclear factor κB (NF-kB), a transcription     factor that participates in the inflammatory response. Although it is a promising treatment,     there are no studies evaluating the effects of resveratrol supplementation in patients with     CKD. Thus, this study aims to evaluate the effects of resveratrol supplementation on     inflammation and oxidative stress in patients undergoing conservative treatment of CKD.   "
65074|NCT02433912|"     BACKGROUND: Several procedures have been reported for the surgical correction of gingival     recession (GR), including the laterally positioned flap (LPF) and the coronally advanced flap     (CAF), performed as single or two-stage procedures without or with, respectively, the     preceding placement and healing of a free gingival graft (FGG). The objective of the present     report was to compare the efficacy of single-stage LPF and CAF techniques in the treatment of     localized maxillary GR defects.      METHODS: Thirty-six patients with Miller class I GR defects were randomly assigned to be     treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession height     (RECH), the width of keratinized tissue (WKT), probing depth (PD) and vertical clinical     attachment level (VAL) were assessed at the mid-buccal site. Visual plaque score (VPS) and     bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings were     performed at baseline, 6 months and 5 years later. Inter-measurements differences were     analyzed with a Chi-square or a Wilcoxon test, with significance set at α<0.05.   "
65102|NCT02433548|"     Femoral neck fracture is very common in the elderly and can produce severe to moderate pain.     As this pathology is not life-threatening, waiting time in the emergency department may be     prolonged due to the high number of unforeseen cases with patients remaining in pain.      Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca,     resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves,     with effective analgesia.   "
65075|NCT02433899|"     BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the treatment     of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed     with the procedure apparently resulting in improved results, however, no previous controlled     clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed as originally     described (MACRO). The objective of the present study was to compare the clinical outcomes of     the MICRO and MACRO SLCRF in the treatment of human GR.      METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned     to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later,     included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT),     probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic     evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed     with a Chi-square or a paired t-test, with significance set at α<0.05.   "
65076|NCT02433886|"     Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional     treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can     be indicated. A previous study, employing bilateral double-shot ventral capsular/ventral     striatal (VC/VS) Gamma capsulotomy (GVC) for OCD has shown that this radiosurgical technique     is potentially efficacious and relatively safe. However, a few patients may develop     complications associated to radionecrosis (eg., brain cysts) in a long-term follow-up, which     are probably associated to lesion volumes. Another study, with the preliminary results of     smaller VC/VS Gamma capsulotomy lesions has suggested that this procedure is safe and remains     efficacious. Our aim is to investigate the efficacy and safety profiles of smaller,     single-shot VC/VS Gamma capsulotomy for OCD. This study will support the development of a     future double-blind, randomized clinical trial of single-shot VC/VS Gamma capsulotomy.   "
65077|NCT02433873|"     The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement     on gut microbiome, gut health, and body weight. Two formulations of the supplement will be     evaluated; thus, there will be three study arms: Supplement A, Supplement B, and placebo.     Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, body weight, and gut     health data will be compared across supplement and placebo groups.      Primary Aim 1: To evaluate the effect of the IMO supplement on gut bacterial abundance,     diversity, and gene function across intervention and placebo groups, and across two doses of     the intervention.      Secondary Aim 1: To evaluate the effect of the IMO supplement on gut health across     intervention and placebo groups, and across two doses of the intervention.      Secondary Aim 2: To evaluate the effect of the IMO supplement on body weight across     intervention and placebo groups, and across two doses of the intervention.      60 subjects, randomized to three arms (20 each: Supplement formula A, Supplement formula B or     placebo) will take a daily dose of Supplement A, Supplement B, or placebo for 8 weeks. The     supplement is a light syrup liquid. Ingredients that are in the supplement are:     isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Ingredients that     are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Dose     will be 500 mg during the first 4 weeks and then 1000 mg for second 4 weeks. Subjects will be     instructed to take 500 mg/day of the supplement or placebo the first four weeks and 1000     mg/day of the supplement or placebo for the second four weeks. Subjects will be blinded as to     whether they are receiving placebo or supplement. After screening and once enrolled, subject     involvement includes visits to George Mason University, being weighed, dropping off stool     samples, and completing a survey on gut health. Stool samples will be analyzed for bacterial     DNA. The gut bacterial DNA, weight, and gut health data will be compared across supplement     and placebo groups.   "
65078|NCT02433860|"     There is a significant need for nicotine cessation programs for pregnant women in Spokane     County. SCRIPT has been proven to be an effective method for smoking cessation in pregnant     women. This study will evaluate the success of SCRIPT delivered by pharmacists. At the end of     the study, the investigators hope to have three questions answered: 1) what is the quit rate     of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by     pharmacists? 2) How does the quit rate compare to the quit rates of SCRIPT programs delivered     by other health care providers as documented in the literature? And 3) Does the SCRIPT     intervention have a significant effect on quit rates for pregnant women compared to current     Spokane county quit rates? Urine cotinine tests will be used to document smoking status     before delivery of the SCRIPT program, approximately one week after quit date and at >36 wks     gestation or at delivery for study participants.   "
65079|NCT02433847|"     Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with     chronic constipation or constipated irritable bowel syndrome.   "
65080|NCT02433834|"     A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment,     Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess     the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label     Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent     Asthma   "
65081|NCT02433821|"     The neck pain comes from disturbances related to the cervical spine, of multifactorial origin     and is considered a frequent problem of disability.      Pilates is a physical conditioning method that has been widely used to improve posture and     develop body awareness.      The aim of this study is to assess the impact of the Pilates method in the control of pain,     function and quality of life in patients with chronic mechanical neck pain.      Methods: 64 patients with chronic mechanical neck pain will be selected and randomized into     two groups: intervention and control. Both groups will be assessed for pain, function,     quality of life and medication intake.      The intervention group will hold Pilates sessions for three months, with two sessions per     week. The control group will continue with the usual drug treatment. Both groups will be     instructed to use 750mg acetaminophen every 6 hours if there is pain, but consumption of the     drug will be controlled.      Although the symptoms of neck pain are common in the population, no study has investigated     the effects of the Pilates method as a possible treatment for neck pain. The hypothesis is     that the Pilates method can offer benefits to these patients.   "
65082|NCT02433808|"     Patients undergoing surgery often receive paralytic agents (or neuromuscular blocking agents     (NMBAs)) to facilitate the procedure. At the end of surgery, the effects NMBAs are reversed     with a drug called neostigmine. The use of neostigmine significantly reduces the risk that a     patient will be left with muscle weakness in the recovery room. Many anesthesiologists     routinely use neostigmine because postoperative muscle weakness may lead to adverse events     after surgery. Other anesthesiologists do not routinely administer neostigmine in the     operating room because of concerns about potential side effects. Surprisingly, some     investigators have reported that neostigmine-induced muscle weakness may occur if the drug is     given when the effects of the NMBAs have completely worn off. In contrast, other     investigators have not observed this side effect when neostigmine was given at the end of     surgery. The aim of this study is to determine whether neostigmine use is associated with     muscle weakness when it is given at the time of nearly complete recovery from NMBAs. Muscle     strength will be measured using a sensitive monitor (TOF-Watch-SX) and through an examination     of the patient for evidence of muscle weakness. Patients will also be evaluated how they     recover from anesthesia and surgery.   "
65084|NCT02433782|"     Designing a treatment protocol using myofascial therapy for the treatment of pain and     restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.      Pilot with a small number of patients for assessment the effectiveness and safety of the     treatment protocol created.      Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in     patients with hemophilia.      Describe the differences in terms of the dependent variables (range of motion, pain and     flexibility) in patients with hemophilia who have carried out the treatment.      Report the relationship between the clinical characteristics of patients and the results     obtained after the treatment period.   "
65085|NCT02433769|"     Muscle relaxants are administered to most patients undergoing general anesthesia in order to     facilitate the placement of an endotracheal tube and improve operating conditions. Despite     routine reversal of these agents, many patients arrive in the recovery room with evidence of     residual muscle weakness. Many studies have demonstrated that residual neuromuscular blockade     (weakness) is a common occurrence after surgery. The only method of reliably detecting the     presence of perioperative neuromuscular blockade is through the use of quantitative     neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and     display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio     of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this     ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the     endotracheal tube can be safely removed. At the present time, there is only one     commercially-available stand-alone quantitative monitor available in the United States -the     TOF-Watch (an acceleromyography device). It is not used by many clinicians because it     requires experience to obtain accurate results, is expensive, and is subject to interference     by factors in the operating room. The aim of this investigation is to examine a new     quantitative monitor, the TOFscan (a new three dimensional acceleromyography device). In     order to study the accuracy of this new device, the TOFscan will be compared to the current     clinical gold standard, the TOF-Watch-SX.   "
65086|NCT02433756|"     The purpose of this study is to observe the evolution of the CRTD system with left     quadripolar lead, in terms of electrical parameters in all pacing configurations and to     evaluate the impact on the clinical outcome.   "
65087|NCT02433743|"     A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital     diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group:     n=32). Individual dietary intakes were measured and compared to the Recommended Dietary     Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA),     hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and     adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and     after 9 weeks home-based follow up.   "
65088|NCT02433730|"     The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in     men with low testosterone due to opioid treatment on body composition, the haemostatic     system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids,     sexual function and quality of life.      Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with     hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40     patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20     patients per arm      A double blinded randomized placebo controlled trial   "
65089|NCT02433717|"     Background Paliperidone is an active metabolite of risperidone, both of which are     antipsychotic agents for treatment of schizophrenia and related psychotic disorders.     Pharmacogenetic studies have revealed that the efficacy and side effects of antipsychotic     agents are related to polymorphisms of specific genes, however, there are just a few related     studies on paliperidone. The current study aims to evaluate whether pharmacogenetic markers     related to risperidone and genetic markers associated with schizophrenia have effects on the     clinical effectiveness of paliperidone treatment. The study also uses changes of     event-related potentials (ERP) as indices for clinical efficacy.      Methods It is a prospective, open-label, non-randomized and uncontrolled clinical trial to     study the efficacy and side effects of 6-week paliperidone ER treatment for patients with     schizophrenia or schizoaffective disorder. The first three weeks of treatment has to be     inpatient treatment. In the first two weeks, participants will take 9 mg paliperidone ER     daily. Then the dose of paliperidone can be adjusted to within the range of 6-12 mg per day.     Efficacy indicators include symptom severity, global functioning, and ERP. Side effect     indicators include common side effect evaluate, extrapyramidal symptoms, metabolic profiles,     hormonal change, and bone metabolism indices. Participants will also receive examinations for     blood drug concentration, genetic polymorphisms, and epigenetic markers.   "
65090|NCT02433704|"     To directly compare acute infection rates in patients undergoing total knee replacement with     intraosseous regional administration or systemic intravenous administration of prophylactic     antibiotics.   "
65091|NCT02433691|"     This pilot study is a first step in a rapidly growing area of clinical research to create the     most effective means to combat age-related losses in cognitive function through preventive     lifestyle strategies such as physical exercise and memory training. This study will develop     innovative simultaneous exercise and memory training programs in non-demented volunteers with     subjective memory complaints (controls or MCI). Our primary goal is to assess the cognitive     impact of 4-week memory training programs done twice weekly: 1. during simultaneous aerobic     exercise (SIM-AR-MET), 2. sequentially after aerobic exercise (SEQ-AR-MET), or 3. without     aerobic exercise (replaced with sequential stretching and toning) (SEQ-ST-MET). The     investigators will also measure potential metabolic (e.g., glucose, lipid panel) and     molecular (serum BDNF) mediators of observed cognitive changes in a subset of participants     (those at the UCLA CTRC/IPCN site).   "
65092|NCT02433678|"     This is a single center, prospective, randomized, placebo -controlled, parallel design and     double blind study to evaluate oxidative stress, inflammation and hypertension markers and     mediators before and after treatment with dapagliflozin.   "
65116|NCT02433366|"     The key focus of this survey will be to collect data on physicians awareness of the content     of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to     patients. The data collected with atrial fibrillation patients will show if and how well this     information is received and understood.   "
65093|NCT02433665|"     1. To determine if a formula derived from PCA using specific patient parameters can be used          to determine the individual contrast material dose and provide a more consistent level          of vascular and parenchymal enhancement during MDCT scanning of the abdomen and pelvis.        2. Up to 500 adult patients referred for a CT of the abdomen and pelvis with contrast          material will be recruited to participate in this trial. Single CT axial slices (n=2)          will be obtained at the level of the L4 pedicle and the supra-acetabular pelvis using a          field-of-view that includes all of the patient. From patient measurements (height,          weight, body dimensions), a customized dose of contrast material will be specified          according to the derived formula for 400 subjects. One hundred subjects will receive the          usual fixed contrast dose.        3. Enhancement data in HU will be measured from the CT scans using manually-placed ROIs on          the upper abdominal aorta, main portal vein and liver parenchyma, avoiding visible liver          tumors, major blood vessels and artifacts, if present. This enhancement data will be          used to determine the patient-to-patient variability.   "
65094|NCT02433652|"     Infection with dengue viruses is the leading cause of hospitalization and death in children     in many tropical Asian countries, and the development of a dengue vaccine is a top health     priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine     to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6     months after the trivalent dengue vaccine.   "
65095|NCT02433639|"     Biliary tract cancer is relatively rare cancer, with generally poor prognosis. In     metastatic/recurrent biliary tract cancer, the most commonly used 1st-line chemotherapy is     gemcitabine+cisplatin combination. However, there is no standard 2nd-line chemotherapy and     there is no validated targeted therapeutic agent, even though this tumor harbors diverse     genetic characteristics.      TH-302 (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophos-phate is     a nitroimidazole-linked prodrug of a brominated version of isophosphoramide mustard (Br-IPM).     When exposed to hypoxic conditions, TH-302 is reduced at the nitroimadazole site of the     prodrug by intracellular reductases leading to the release of Br-IPM. Br-IPM can then act as     a DNA crosslinking agent. In areas of normoxia, TH-302 remains intact as a prodrug and     toxicity is minimized. In addition, preclinical data suggest that after activation, the     active moiety may diffuse to areas outside the hypoxic region, demonstrating a bystander     effect and possibly exhibiting additional anti-tumor activity.      It is well known that biliary tract cancer is hypovascular tumor, so it contains large     hypoxic area in the tumor. Therefore it would be worthy to test TH-302 in biliary tract     cancer.      This study is a phase II study of TH-302 monotherapy as second-line treatment in advanced     biliary tract cancer, to investigate efficacy and safety of TH-302 monotherapy.   "
65096|NCT02433626|"     Activity of COTI-2 has been demonstrated in the OVCAR-3 ovarian cancer tumor model. With its     p53- and AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in     treatment of patients with gynecologic malignancies.      This study is designed primarily to assess the safety and tolerability of COTI-2 in patients     with advanced and recurrent gynecologic and head and neck malignancies and to establish a     recommended Phase 2 dose (RP2D) for future studies.   "
65097|NCT02433613|"     Prospective, multi-center, single-arm, non-interventional and open-label registry. The     purpose of the registry is to document use of Phased Radio Frequency Ablation (hereafter     Phased RFA) System in a real world patient population with atrial fibrillation and evaulate     its performance.      Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38     sites in Western, Central Europe, Israel and South Korea.   "
65098|NCT02433600|"     This study is intended to measure declarative or stored memory and behavior between infants     who consume one of two infant formulas through approximately one year of age.   "
65099|NCT02433587|"     The primary objective of the trial is to evaluate short versus long duration dual     antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.   "
65100|NCT02433574|"     Despite improved staging and operative techniques, the rate of incomplete resection (R1) of     NSCLC has remained significant over the last decades. Patients with R1 resection have     significantly worse survival compared to those with complete resection (R0).      This is a phase I study that investigates the feasibility and safety of delivering     Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1)     who are at risk for incomplete resection.      Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate     adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with     escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions.      The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery     (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates     and secondary surrogates of feasibility.      If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.   "
65101|NCT02433561|"     Continuous interscalene brachial plexus block consists of inserting a catheter directly     within the brachial plexus in the interscalene groove, between the middle and anterior     scalene muscles, which is then infused with local anesthetic. This technique provides potent     and site-specific analgesia for several days after major shoulder surgery, along with     increased shoulder range of motion. A major side-effect of this procedure is the paralysis of     the ipsilateral diaphragm, which is the main muscle of the respiration. This paralysis occurs     at a rate of 90 to 100%, and is due to the spread of the local anesthetic towards the phrenic     nerve, lying anteriorly to the plexus, between the sternocleidomastoid and anterior scalene     muscles. Therefore, many patients suffering from respiratory syndromes, such as chronic     obstructive pulmonary disease, will not have a continuous interscalene brachial plexus block,     thus forfeiting some, or all, of the aforementioned benefits associated regional anesthesia.      It is conventionally taught to place the needle tip between the nerve roots of the brachial     plexus to obtain an effective block (intra-plexic injection). Recently, we have published a     new technique of single-shot injection for interscalene brachial plexus block where the     needle tip was positioned at a distance of 4 mm of the lateral part of the brachial plexus     (extra-plexic injection) and resulted in a reduction rate of 70% of hemidiaphragmatic paresis     and a preservation of spirometric values, while providing similar analgesia, when compared to     a conventional injection. Contrary to single-shot injections where high volume and high     concentration of local anesthetics are injected (eg, ropivacaine 0.5%, 20 mLs), continuous     blocks required low volume and low concentration (eg, ropivacaine 0.1-2%, 2-6 mLs/h) and     therefore the aforementioned concept of extra-plexic technique might not be suitable.      Recently, new catheter-over-the needle (Contiplex® C; B. Braun Melsungen AG, Germany) have     been released on the market and allows the physician to place the catheter tip exactly where     he desires, contrary to the previous generations where the catheters were inserted blindly,     despite the use of ultrasound.      The first objective of that randomised controlled trial is to demonstrate that an     extra-plexus catheter placement produces less respiratory complications than an intra-plexus     catheter placement. The second objective is to confirm that both techniques provide similar     analgesia.   "
71882|NCT02344875|"     The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics     after single oral administration of FYU-981 to male and female elder subjects in comparison     with non-elder subjects.   "
65103|NCT02433535|"     This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to     inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation,     improve lung function and symptoms, and reduce acute exacerbations in patients with severe     asthma who are already on controller inhaler therapy.      This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized     clinical trial, titled Randomized Trial of Simvastatin for the Treatment of Severe Asthma,     will be conducted at the University of California, Davis Medical Center (UCDMC) in     Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with     severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking     inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic     asthma.      The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily)     will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will     also reduce acute exacerbations and improve lung function. All patients will be on standard     controller therapy including appropriate doses of inhaled corticosteroids and long-acting     bronchodilators.   "
65104|NCT02433522|"     MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for     ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18)     was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the     inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN,     up to 30% of patients experienced a relapse 38 months after the last rituximab infusion     (unpublished data). Right now, no randomized controlled study has been carried in order to     evaluate the best duration of the maintenance treatment with rituximab.      The investigators objective is to evaluate the efficacy of a long term rituximab treatment to     prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase     of rituximab maintenance treatment.      The investigators will conduct a randomized placebo-controlled trial of a long term rituximab     maintenance treatment (46 months) against a conventional maintenance treatment (18 months).   "
65105|NCT02433509|"     The objective of the study is to determine the safely of Human Umbilical Cord Blood     mononuclear cells by Intravenous injection in acute ischemic stroke patients.   "
65106|NCT02433496|"     This project pilot tests an innovative clinical guideline translation and physician coaching     model to promote adherence to evidence-based guidelines for the prescribing of opioid pain     medications in primary care settings.   "
65107|NCT02433483|"     Allogeneic transplant can sometimes be an effective treatment for leukemia. In a traditional     allogeneic transplant, patients receive very high doses of chemotherapy and/or radiation     therapy, followed by an infusion of their donor's bone marrow or blood stem cells. The     high-dose chemotherapy drugs and radiation are given to remove the leukemia cells in the     body. The infusion of the donor's bone marrow or blood stem cells is given to replace the     diseased bone marrow destroyed by the chemotherapy and/or radiation therapy. However, there     are risks associated with allogeneic transplant. Many people have life-threatening or even     fatal complications, like severe infections and a condition called graft-versus-host disease,     which is caused when cells from the donor attack the normal tissue of the transplant patient.      Recently, several hospitals around the world have been using a different type of allogeneic     transplant called a microtransplant. In this type of transplant, the donor is usually a     family member who is not an exact match. In a microtransplant, leukemia patients get lower     doses of chemotherapy than are used in traditional allogeneic transplants. The chemotherapy     is followed by an infusion of their donor's peripheral blood stem cells. The objective of the     microtransplant is to suppress the bone marrow by giving just enough chemotherapy to allow     the donor cells to temporarily engraft (implant), but only at very low levels. The hope is     that the donor cells will cause the body to mount an immunologic attack against the leukemia,     generating a response called the graft-versus-leukemia effect or graft-versus-cancer     effect, without causing the potentially serious complication of graft-versus-host disease.      With this research study, the investigators hope to find out whether or not     microtransplantation will be a safe and effective treatment for children, adolescents and     young adults with relapsed or refractory hematologic malignancies   "
65108|NCT02433470|"     In the study the investigators aim to test whether transcranial direct current stimulation     (tDCS)-induced pain reduction is in association with functional changes in the brain measured     with magnetic resonance imaging (MRI) in patients with chronic inflammatory bowel diseases     (IBD).      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in     patients with chronic inflammatory bowel diseases, which is in association with changes in     the brain measured via MRI.   "
65109|NCT02433457|"     To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292     P22 tablet.   "
65110|NCT02433444|"     In this study, the investigators aim to distinguish patients with Post-Endoscopic retrograde     cholangiopancreatography (ERCP) Pancreatitis (PEP) vs. those without PEP based on difference     in pre- vs. post-ERCP measurements of AGIS-derived intestinal rates (IR). Based on the     clinical observation that many patients with PEP develop ileus following ERCP, the     investigators hypothesize that patients who develop PEP will exhibit lower IR following ERCP,     and therefore a larger difference in pre- vs. post-ERCP IR.   "
65111|NCT02433431|"     The purpose of this study is to test the active components of mindfulness meditation for     reducing psychological stress and improving biomarkers of health. This study compares the     effects of three brief trainings: (1) training in both present-moment attention and mindful     acceptance, (2) training in present-focused attention, and (3) an active psychological     training with no mindfulness content.   "
65112|NCT02433418|"     300 women with unexplained infertility will be randomly divided into 2 equal groups: Group 1     will be offered tubal flushing with water soluble media through hysterosalpingography (HSG)     and group 2 will receive no intervention   "
65113|NCT02433405|"     The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum     Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal     health and disease.   "
65114|NCT02433392|"     The purpose of this trial is to determine the safety and feasibility of injecting irinotecan     hydrochloride drug-eluting beads directly into the cavity remaining after a tumor is     surgically removed in patients with a type of brain tumor (glioblastoma multiforme - also     known as glioma) that has returned after prior therapy.   "
65115|NCT02433379|"     This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with     the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden     cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order     to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence     of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks     observed in the MADIT RIT study.   "
66300|NCT02417870|"     To investigate the safety and tolerability of treatment with low dose rIL-2 in renal     transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant     recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.   "
65117|NCT02433353|"     Approximately 150 active duty service members meeting Diagnostic and Statistical Manual     version 5 (DSM-5) criteria for posttraumatic stress disorder (PTSD) and scoring 50 or above     on the Clinician Administered PTSD Score for DSM-5 (CAPS-5) will be recruited. Qualifying     participants will be randomized on a 1:1 basis to either the eye movement desensitization     reprocessing (EMDR) plus venlafaxine XR group or the EMDR plus placebo group. Protocol will     call for participants to complete 12 one-hour EMDR session while taking a venlafaxine     XR/placebo dose of 150mg or 225mg for the entire 24 weeks. Both prescribers and therapists     will be blinded and CAPS-5 assessments will be completed by an individual not involved in a     participant's direct treatment. An unblinded pharmacist will dispense medication or placebo     according the instructions of the prescriber and will count remaining tablets to measure     compliance. All EMDR sessions will be recorded and will be reviewed by the principal     investigator using a fidelity checklist. CAPS-5 will be administered after completion of EMDR     and again at 6 months from the date of his/her first therapy session.   "
65118|NCT02433340|"     This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of     ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to     methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized     controlled trial, in which participants had been randomized to receive 1 of 3 doses of     ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab     40 mg EOW given on background methotrexate.   "
65119|NCT02433327|"     Critical illness in the patient and death can potentially be predicted and prevented.     Deterioration of the clinical condition of hospitalised patients is often preceded by     physiological changes up to 24 hours before death. Despite this several reports show that     lack of identification and proper actions in patients developing acute and critical illness     remains a problem.      The purpose of this study is to investigate if Paediatric early Warning Score (PEWS)     optimises identification of acute and critically ill children and prevents life-threatening     situations. The hypothesis is that implementation of PEWS supported by directions for action     algorithms for intervention will have an impact on number of unplanned transfers to intensive     care in already hospitalised children.      This study is a multi-centre randomised controlled intervention study designed within a     Complex Intervention framework; the study sheds light on the problem, validation of the data     collection instrument, testing of the intervention and evaluation. The study involves all     paediatric departments and some acute departments in Central Denmark Region. The study is     designed as a randomised controlled intervention study where children are randomised to one     of two different Paediatric Early Waning Score models.      Development and implementation of PEWS is expected to contribute to reduce the number of     children developing acute critical illness, number of admissions to intensive care. PEWS is     also expected to contribute to increase professional skills and competences in health     professionals. It is expected that this study will contribute towards working with a joint     PEWS model in Denmark. Last but not least it must be expected that a PEWS model will     contribute to reducing the costs for society as an intensive care hospital bed is more     expensive than a hospital bed at a general paediatric department.   "
65120|NCT02433314|"     This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to     subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a     continuous intravenous infusion to these subjects   "
65121|NCT02433301|"     The incidence of malignity in the gastroesophageal junction (GEJ) is rising in Denmark, 400     new cases annually 1. 60% of the patients with GEJ cancer have disseminated disease     (M1-stage) at time of diagnosis and are consequently unable to undergo curative intended     surgery. The prognosis is poor, with 5-year survival rates of approximately 2 % for these 60%     and the treatment only consists of palliative therapy 1. For the remaining approximately 40 %     who are assessed as candidates for curative intended surgery, the 5-year survival rate is 33     % 1. This emphasizes the need for further research and knowledge concerning tumour biology     and spontaneous course of the disease.      In Denmark, all cancer patients are enrolled in a specific cancer program. The primary     diagnostic work-up for GEJ cancers includes gastroscopy with biopsy, blood samples,     ultrasonography scan, Positronemissionstomography (PET) and Computed tomography (CT) alone or     PET/CT in combination 2. From these parameters physicians determine resectability and     TNM-stage (tumour staging), which is substantial for the prognosis and future treatment. The     primary goal is to achieve a macroscopically resection of tumour and lymphnodes in relation     to the stomach and oesophagus (Esophagectomi a.m. Ivor Lewis and D1+ lymphadenectomy in the     abdomen and thorax). In addition to surgery, patients receive perioperative chemotherapy,     which consist of three series of chemotherapy preoperative and three series postoperative     approximately 21-28 days after surgery.      Approximately 12.6 % of patients receiving perioperative chemotherapy prior to surgery will     have disease progression due to chemotherapy resistance during the therapy 3. This     unintentionally leads to shifting these patients from the resectable group to non-resectable     group (palliative treatment). Thus, the possibility for detecting response to perioperative     chemotherapy is of great interest. A paradigm shift towards an individualised tailored     therapy form has emerged in recent years, which potentially require a higher need for     diagnosis on molecular level. Today most molecular biological methods apply tissue samples     for in-vitro analyses, but new radiological tools provide opportunity for non-invasive     examinations; for example PET can with a radioactive sugar compound: Flour-18 deoxyglucose     (18F-FDG). This compound is injected through a catheter in a larger vein (media cubiti vein)     and absorbed in cells with increased metabolism - especially cancer cells. A PET scanner     registers the absorption; this radiology modality can provide valid information, which is     essential for non-invasive tumour staging and monitoring response under a specific therapy.      A new diagnostic modality is PET scan combinated with magnetic resonance (PET/MR)     simultaneously. So far, no studies have conducted an evaluation of simultaneous PET/MR scan     to assess the perioperative chemotherapy response in patients with GEJ cancer. However, some     studies suggest that commercially available PET/MR scanner might contribute in a diagnostic     elucidation 6. Simultaneous PET/MR scan might in theory minimize the misinterpretations of     potential response changes after chemotherapy, which can appear in the interval between     separate PET, CT and MR scans 4,5,7. Studies have found PET scan of GEJ cancer could be     helpful as a prognostic tool to differentiate between responders and non-responders during     chemotherapy 9. Standardized uptake value (SUV) is a unit that display the absorption of     18F-FDG and is used routinely to quantify tumour glucose metabolism in PET scan 8. A change     of more than 35 % in SUV measurements before and after the induction of chemotherapy is     considered as the definition of responders and non-responders in earlier studies 9.      The MR technique is based on magnetic fields and radio waves. Diffusion Weighted Imaging     (DWI) is a non-invasive MR-modality, which measures the changes in water diffusion (Brownian     movements) throughout tissue. These changes are measured in Apparent Diffusion Coefficient     (ADC), a parameter derived from DWI and reflects the change in diffusion 7. ADC and DWI can     be used to differentiate between benign and malignant tumours, due to a larger cell density     in malignant tumours. Consequently, malignant tissue has a decreased diffusion relative to     normal tissue. ADC has been used as a factor in some studies to predict the response to     chemotherapy 10. A single study has shown a rise in ADC-value two weeks after initiation of     chemotherapy in patients with GEJ cancer, and demonstrated that the percentage change in     ADC-value between the groups (responders and non-responders) is significantly different 11.     Simultaneous PET- and MR scan might be very useful to evaluate the response to chemotherapy     in patients with GEJ cancer compared with these parameters alone. The opportunity for a more     individualised tailored treatment in future might be possible with PET/MR.   "
65122|NCT02433288|"     This is a randomized, two-arm, open label, Phase IV clinical trial to evaluate if the     provision of a smart phone-based patient support tool prolongs the patient's rosuvastatin     treatment duration.   "
65123|NCT02433275|"     CHildhood ASthma and Environment Research study - CHASER study is an observational     longitudinal study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of     Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular     Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.      The first phase - transversal study will identify determinants of pediatric asthma control      The second phase - longitudinal study (2 year follow-up), in patients with persistent asthma,     will be focused on:        -  predictors for asthma exacerbations and loss of control        -  real life adherence to asthma therapy guidelines        -  phenotypic characterization through the collection of saliva samples        -  assessment of alterations and inflammatory changes in the nasal mucosa through nasal          brushing      Chaser Project is expected to improve the knowledge of pediatric asthma in patients with     different level of control, identifying predictors for asthma exacerbations and loss of     control.   "
65124|NCT02433262|"     Aim for this study is to measure the prevalence of Gestational Diabetes Mellitus (GDM) using     World Health Organisation (WHO) versus International Association of Diabetes in Pregnancy     Study Group (IADPSG) criteria among pregnant mother in Universiti Kebangsaan Malaysia Medical     Centre (UKMMC)   "
65125|NCT02433249|"     The purpose of this pilot study is to develop an intervention, based on empirical evidence     and health-related behavioral change theory, to enhance motivation for engaging in     fall-reducing physical activities.   "
65126|NCT02433236|"     Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib     in approximately 25 subjects. The study will consist of 11 visits over 15 months.   "
65127|NCT02433223|"     The purpose of this project is to evaluate hospital utilisation, patient and service outcomes     of a Respiratory Nursing Service to examine current clinical care of COPD. This evaluation     aims to identify the important gaps in current clinical care of respiratory chronic disease     nursing management. The primary outcomes of this evaluation is to determine the efficacy of     clinical care in 2006, 2011 and 2013 and compare data to current Nursing Best practice     guidelines for COPD through the quantification of hospital utilisation for hospital     admission, average length of stay, readmission within 28 days, emergency service attendance,     outpatient review, use of Hospital and Home (H@H), frequency of exacerbations, disease     severity and progression (FEV1: GOLD Classification), number of contacts with the respiratory     nursing service and type of contacts with the respiratory nursing service.   "
65128|NCT02433210|"     The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H     and to compare its performance characteristics and hemocompatibility with those of the     commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.      10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood     samples for several parameters will be collected during hemodialysis to assess the     performance and hemocompatibility of the dialyzers under study. Data thus collected will be     analyzed for comparison by standard statistical analysis.   "
65140|NCT02433054|"     The purpose of this study is to examine patency rates of self-expanding nitinol stents for     treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis.     Moreover, clinical outcome data of patients treated with these venous stents will be     collected.   "
65129|NCT02433197|"     Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however     impaired muscle function and fatigue are the most common complications among patients with     GCC undergoing treatment with chemotherapy. Although exercise is widely recommended,     information about physiopathological effects of cancer therapy in skeletal muscle is very     limited.      Methods/Design: The present study is a randomized controlled trial comparing an     individualized program of muscular strength and endurance with aerobic training compared to a     control group. All variables will be measured at the beginning and at the end of a 8-week     intervention by the same evaluator, who will hide the disposition of participants to each     group. Besides, it will be monitoring during de following 6 months (24 weeks) after training     for all outcome variables.   "
65130|NCT02433184|"     The main aim of the study is to determine whether TNFi instituted as first-line therapy in     early RA confers better outcomes (clinical, structural and immunological) compared to delayed     TNFi start; implying particular dominance of TNF in early disease, a changing role of TNF     with disease duration and hence, confirmation of a biological window of opportunity.   "
65131|NCT02433171|"     The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport     and microglial activation to improve the differentiation of tumor recurrence and radiation     necrosis in patients with brain metastases after treatment with stereotactic radiosurgery     (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in     combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET     (fluorodeoxyglucose).   "
65132|NCT02433158|"     This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have     completed the double blind Phase 3 study (B5201002).   "
65133|NCT02433145|"     The current study using the longitudinal study in preschool children to exam three study     issues: 1) using the neuropsychological functions (ie. Behavioral inhibition, delay aversion,     the variability of reaction time) among the preschool children predict the ADHD diagnosis and     behavior symptoms in 1.5 years later. 2) using the behavior inhibition, delay aversion and     the variability of reaction time (using the parameter among Gaussian distribution and     ex-Gaussian distribution) explore the association between attention and motor inhibition     problems. 3) explore the transaction effect between the neuropsychological functions and     family function and parenting to predict ADHD comorbidity with oppositional defiant     disorder.4) explore the association between the internalizing/ externalizing problems of ADHD     and temperament. The current study has opportunity to describe and to answer the complicated     problems for heterogeneous neuropsychological deficits in ADHD, and to elucidate the core     issues for ADHD have comorbid with ODD. The most important contribution is to offer the     empirical evidence to make a clean suggestion in ADHD diagnosis and intervention in preschool     age.   "
65134|NCT02433132|"     The diagnosis of CF is currently based on the discovery of two CFTR gene mutations and / or a     positive sweat test (> 60mmol / l). A significant number of patients with atypical cystic     fibrosis (chronic sino-pulmonary disease with a single mutation in the CFTR gene and / or a     test of the intermediate sweat between 30 and 60 mmol / l) undetected by these techniques are     behind specialized care while irreversible lung damage is already existed. Currently, the     measurement of nasal potential difference in vivo (DPN), which evaluates the transportation     of chlorine in the nasal epithelium with an electrode, is proposed for the diagnosis of     atypical forms. However DPN dependent nasal local conditions when analysing do not always     offer the possibility of concluding the diagnosis of cystic fibrosis. It is necessary to     develop new and more reliable diagnostic tests for the detection of cases of atypical cystic     fibrosis. The authors propose to develop a new diagnostic technique based on the study of     bioelectric properties of a preparation of nasal cells of the subject obtained by brushing     and placed in primary culture (CCBN).   "
65135|NCT02433119|"     A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and     safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with     essential hypertension uncontrolled with valsartan 160mg monotherapy   "
65136|NCT02433106|"     A randomized control trial examining the effects of an exercise based injury prevention     programme on postural control and jump landing mechanics. Randomization of 4 teams, 2 Gaelic     football and 2 hurling teams to exercise intervention and control groups. Participants are     tested using Y Balance test and Landing Error Scoring System (LESS).   "
65137|NCT02433093|"     The study will assess the safety, tolerability, and pharmacokinetics of basimglurant compared     to placebo after multiple ascending oral doses for up to 22 days in healthy subjects and in     patients with MDD on stable selective serotonin reuptake inhibitor (SSRI) or     serotonin-norepinephrine reuptake inhibitor (SNRI) background therapy.   "
65138|NCT02433080|"     Endometrial cancer is the most common gynaecological cancer in developed countries with more     than 75% of the patients surviving for at least five years. However, most endometrial cancer     survivors are overweight and obese and do not meet the current nutrition and physical     activity recommendations. This can lower their quality of life and increase their risk for     chronic diseases. Behaviour change interventions can help them feel better about themselves     and improve their quality of life. Applying them shortly after treatment seems ideal as     cancer survivors feel motivated to make changes about their lifestyle at this time point.      This study is to see if the investigators can design a project to measure how well a     psycho-educational healthy eating and physical activity programme tailored to the survivors'     needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three     years, and are all clear will be put by chance into one of two groups. One will receive the     program. The other will receive usual care until the end of the trial and, then, a discussion     and a self-help guide about eating well and being active following cancer treatment. This     will help us to see if the programme makes a difference compared with usual care. The results     will inform a larger study to test if a lifestyle program can improve the quality of life of     uterine cancer survivors compared with usual care. The investigators will change the     programme materials in response to the investigators' findings, making them available to     services. The results will inform practice and research.   "
65139|NCT02433067|"     Purpose of the study is to examine the effects of 3 months of physical activity intervention     on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast     cancer   "
65142|NCT02433028|"     The key aims of the Swiss Multiple Sclerosis Cohort-Study (SMSC) are        1. To maintain a long-term cohort (>10 years) representative of the MS population currently          living in Switzerland. This requires effective measures to limit drop-outs and the          continuous recruitment of MS patients and        2. To conduct a systematic follow-up with standardized, high quality collection of clinical          and magnetic resonance imaging (MRI) data, as well as body fluids.      The significant heterogeneity within the diagnostic entity and phenotype of multiple     sclerosis (MS) is incompletely understood. A central and necessary prerequisite of further     advance is a sufficient amount of high quality clinical and paraclinical (imaging, body     fluids) patient data.      Nested projects will address specific research topics, and facilitate collaboration of the     most qualified investigators within the group of SMSC investigators. The nested projects will     focus on the:        1. Development and validation of diagnostic and prognostic markers of spontaneous disease          evolution and therapeutic response.        2. Exploration of the safety and impact on long-term disability of existing and next          generation MS treatments        3. Individualized therapy: A number of highly active but potentially also harmful therapies          have lately been established for the treatment of MS. To date, due to the lack of          individual prognostic markers patients may not receive aggressive therapy due to safety          concerns, or patients with benign disease may receive expensive and potentially harmful          treatments without the need for it.   "
65143|NCT02433015|"     The objective of this study is to examine the cognitive, immunological, and     neurophysiological effects of transitioning from tobacco cigarettes to electronic cigarettes.     The central hypothesis of this study is that this transition will be accompanied by a     decrease in peripheral inflammation, which will lead to significant changes in the     neurocircuitry underlying interoception and appetite.   "
65144|NCT02433002|"     The eGFR-C study will assess the accuracy of current and alternative tests of kidney function     against a reference test in people with moderate (stage 3) chronic kidney disease (CKD).   "
65145|NCT02432989|"     This is a Phase 1 study to determine (1) the safety of an exercise protocol in adolescents     and young adults with concussion in the first week post-injury and (2) to evaluate the     effects of mild symptoms on brain function using EEG. This pilot study will inform subsequent     grant applications, and a Phase II randomized control trial that will explore the influence     of age on an early re-introduction to exercise, as well as the influence of varying intensity     levels of exercise.   "
65146|NCT02432976|"     A diminution of quality of life is often reported by patients after coronary artery bypass     graft (CABG) surgery. A part of this diminution could be explain by postoperative left     ventricular (LV) dysfunction.      Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect     that depends on the blood glucose level. Recent data have suggested that exenatide could     improve LV function by an inotropic effect in patients suffering from cardiogenic shock or     from congestive heart failure. Moreover, patients suffering from congestive heart failure     reported a better quality of life when they were treated with exenatide compared to placebo.      The investigators hypothesize that perioperative exenatide infusion could improve     postoperative quality of life in CABG surgery patients.   "
65147|NCT02432963|"     This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating     patients with solid tumors that have spread to other places in the body and usually cannot be     cured or controlled with treatment, that have failed prior therapy, and that cannot be     removed by surgery. Vaccines made from a gene-modified virus may help the body build an     effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab,     may block tumor growth in different ways by targeting certain cells. Giving vaccine therapy     together with pembrolizumab may be a better treatment in patients with solid tumors.   "
65148|NCT02432950|"     This pilot clinical trial studies a pancreatic nutritional program for helping patients with     stage I-III breast cancer who are overweight or obese lose weight. When patients have a high     level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the     pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and     other illnesses. Breast cancer patients who are overweight and obese are more likely to have     their breast cancer return. The pancreatic nutritional program is a diet and lifestyle     intervention that helps protect the pancreas by keeping blood sugar levels low, and may help     patients achieve sustained weight loss, improved health, better quality of life, and possibly     a better outcome to their treatment.   "
65149|NCT02432937|"     The study primarily aims to compare the effects of two doses of Corever with placebo in     patients with hypertension.   "
65150|NCT02432924|"     The primary aim of the study is to examine whether the provision of personalised     multidimensional physical activity profiles (derived from technological advances in physical     activity monitoring) is supported by instantaneous physical activity feedback in fostering a     meaningful change in physical activity behaviour amongst adults.   "
65151|NCT02432911|"     This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in     elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.   "
65152|NCT02432898|"     Evaluate the clinical information obtained from the use of the machines.   "
65153|NCT02432885|"     This trial intends to evaluate myocardial Fibrosis progression in Duchenne and Becker     Muscular Dystrophy, as well the influence of ACE inhibitors in fibrosis progression.     Additionally, this study aims to determine genetic predictors of cardiac involvement in these     dystrophies.   "
65154|NCT02432872|"     The purpose of this study is to determine whether the escalation dosage of Daunorubicin and     cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid     leukemia（AML） patients aged 55 to 65 years.   "
65155|NCT02432859|"     The purpose of this study is to determine whether electrical stimulation is effective in the     expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.   "
71925|NCT02344316|"     Migraine in adolescents is common and effective and safe preventive treatments are needed.     This is a pilot randomized controlled trial of melatonin versus placebo for migraine     prevention in adolescents 12-17 years old.   "
65156|NCT02432846|"     The purpose of this study is to compare tumor response, progression free survival (PFS) and     overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax pre-nephrectomy     followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy in non-vaccinated     patients.   "
65158|NCT02432820|"     SPECIFIC STUDY AIMS        1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT          scans co-registered with transperineal US scans acquired with an optically and/or          electromagnetically tracked matrix array ultrasound transducer.        2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array          transducer imaging and grey-level based image registration algorithms.   "
65159|NCT02432807|"     This is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride     ophthalmic ointment dosed 4 times daily for 7 days compared to placebo (vehicle) in patients     with moderate to severed Gram-positive bacterial conjunctivitis.   "
65160|NCT02432794|"     This is a randomized clinical trial to clarify if the delay phenomenon could reduce the     incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer     comparing an experimental group vs control group. The delay phenomenon will be performed by     an arteriographic approach.   "
65161|NCT02432781|"     The primary purpose of this study is to investigate the effects of carbohydrate-rich drink on     postoperative nausea and vomiting in diabetic patients undergoing total knee arthroplasty.     The secondary purpose is to investigate the effects of carbohydrate-rich drink on quality of     recovery and inflammation in diabetic patients after total knee arthroplasty.   "
65163|NCT02432755|"     The specific aims of this study will be:        1. To compare the immediate and retention treatment effects of the patients receiving          home-based mirror therapy combined with task-oriented training (MTOT) with a          hospital-based MTOT group and a hospital conventional rehabilitation group on different          aspects of outcomes.        2. To examine the feasibility, satisfaction, and safety of this novel home-based MTOT          program.        3. To investigate the factors that may affect the efficacy of home-based stroke          rehabilitation.   "
65164|NCT02432742|"     The purpose of this study is to determine the safety and efficacy of using Restylane Perlane     compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a     Chinese population.   "
65165|NCT02432729|"     The purpose of this study is to understand the biological and functional changes after one     year of smoking cessation and to collect data on a broad range of biomarkers of exposure     (BoExp).   "
65166|NCT02432716|"     This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot     study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo     in patients with DS. Subjects will be randomized into this cross-over study and within     subject comparisons conducted between single treatment of intranasal insulin glulisine and     single treatment of intranasal placebo. All subjects will also receive a single treatment of     placebo prior to randomization to ensure adherence to study procedures.   "
65167|NCT02432703|"     The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of     treatment in participants with Social Anxiety Disorder (SAD).   "
65168|NCT02432690|"     This is an open label, single-arm, phase II study. The study population is adult patients     with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.   "
65169|NCT02432677|"     The purpose of this study is to evaluate the potential additive effect of tDCS compared to     placebo-sham in opioid analgesia on pain thresholds in nociceptive experimental model in     healthy volunteers .   "
65170|NCT02432664|"     The purpose of the study is to investigate to what extent this new study drug is tolerated in     humans.      The study is divided into 3 parts (Part III is optional and may go ahead depending on the     results of Parts I and II). The volunteers will only be enrolled to one part of the study. In     parts I and II the volunteer will receive active study drug or placebo. In part I the     volunteers will receive a single dose of one of the eight planned escalating dose levels.      In part II volunteers will receive 4 planned dose levels based on the results obtained in     Part 1 of the study, with the option to include an additional dosing group.      In optional part III the volunteer will receive ODM-108 and an already registered drug so     that interactions with other drugs can be studied.      It will be investigated how quickly and to what extent the study drug is absorbed and     eliminated from the body (this is called pharmacokinetics). In addition, in parts I and II     the effect of the compound on the sensation of pain and on cognition (activities of thinking,     understanding, learning, and remembering) will be investigated (this is called     pharmacodynamics).   "
65183|NCT02432495|"     The management of type II odontoid fractures in geriatric trauma victims remains a source of     substantial controversy. The purpose of this study was to compare anterior screw fixation     with halo-vest-immobilization in patients with type II odontoid fractures.   "
65171|NCT02432651|"     The purpose of this research study is to learn if and in what amount a compound from hops,     called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human     body is constantly exposed to oxidative stress from environmental compounds (e.g. air     pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too     much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world     has shown that xanthohumol can stop or slow processes that lead to cancer.   "
65172|NCT02432638|"     The purpose of this prospective, multi-center, longitudinal study is to assess clinical     outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO (Mandibular     distraction osteogenesis). This study aims to develop a scoring system to determine success     and complication rate pre and post MDO.   "
65185|NCT02432469|"     The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent     coronary artery bypass grafting in 1 of 5 participating sites in 2015, and randomized to     either the intervention group or control group, to test the effectiveness of a smartphone     based application (APP) focusing on improving patients medication adherence. Patients     randomized to the intervention group install the APP in their smartphones with personnel     information and physicians' medication descriptions. The APP reminds at the time of taking     medications, educates them on secondary prevention for coronary artery disease, and collects     their weekly situations by questionaires. Investigators will follow-up patients by face to     face or telephone interview. The 6-month effects of the intervention are evaluated.   "
65542|NCT02427776|"     The purpose of this study is to assess the safety and the preliminary efficacy of a single     infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple     Sclerosis.      The study duration for the patients (from start of baseline to end of follow-up) is 270 days.   "
65173|NCT02432625|"     Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People     with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and,     in adult years, hearing loss. It is seen in both genders and all races. OI can range from     very severe to very mild. Individuals with the most severe type of OI may die at birth.     People with severe OI who survive may have bowed arms and legs, very short stature and be     unable to walk. People with the mildest form of OI may only break bones occasionally and have     normal height and lifespan. People with OI also often have problems with the spine. The spine     problems include compression fractures and scoliosis (a curvature of the spine). DI is     characterized by grey or brown teeth that may chip and wear down and break easily.      Before the genetic cause of OI was known, OI was classified into four types. Each type was     based upon the symptoms and severity of OI. In most people with OI, the cause is a change in     one of the genes that makes a protein called type 1 collagen. In the past decade, it was     discovered that in about 5% of people with OI it is in another gene. Some doctors now     classify OI both on how severe it is as well as which gene is causing OI.      Our research aims are:        1. Perform DNA testing and collect natural history data on all individuals enrolled in this          longitudinal study. The genetic cause of the brittle bone disease will be compared with          things like severity, various features and response to treatments.        2. We will see how often people with type I OI have vertebral compression fractures of the          spine. We will do x-rays to see how often they get compression fractures of the          vertebrae, what happens over time and any risk factors that increase the risk of these          compression fractures.        3. We will follow people with all forms of OI to see how often they develop scoliosis          (curvature of the spine). We will look at the effects of scoliosis on lung function,          ability to walk and quality of life. We will also look at the effects of various          treatments (bracing, surgery, etc.) on scoliosis and lung function.        4. We will look at dental health in people with OI. We will see how often people with OI          have problems with teeth alignment. Importantly, we will see how dental health impacts a          person's quality of life.   "
65174|NCT02432612|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal     dose of Sativex in subjects with advanced cancer currently on background Step III opioid     therapy.   "
65175|NCT02432599|"     The rationale for the proposed pilot study is to investigate the ability of PET-CT with     F18-choline to detect and locate the parathyroid adenoma in patients with primary     hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical     ultrasound, in order to avoid unnecessary bilateral cervical exploration.   "
65176|NCT02432586|"     18 preschool aged children and their families will attend structured, multidisciplinary,     family-centered intensive education sessions over a 3-day weekend in a residential camp     setting to address the unique challenges of managing type 1 diabetes mellitus in young     children. A second 'booster' session, will be conducted 6 months later.   "
65177|NCT02432573|"     In postpartum hospitalized women, does delayed morning rounding improve patient satisfaction?   "
65178|NCT02432560|"     The MIDAS study aims to follow women with LAM who are currently taking, have previously     failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or     everolimus as part of their clinical care.   "
65179|NCT02432547|"     This will be a 24 month phase IV, randomised, prospective, multicentre, clinical trial of     laser therapy to areas of peripheral retinal ischaemia combined with intravitreal aflibercept     versus intravitreal aflibercept monotherapy. Both arms will have 2mg intravitreal aflibercept     according to a treat and extend protocol.      The specific aim of the study is to test whether laser therapy of peripheral retinal     ischaemia reduces the overall number of intravitreal aflibercept injections required to     control DMO over a 24 month period.   "
65180|NCT02432534|"     Condition:      Non segmental and active vitiligo of adulthood.      Main objective:      To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB     compared to UVB alone in active vitiligo after 6 months of treatment.      Methods:      Prospective interventional bicentric study with evaluation blinded to the treatment received.      Inclusion criteria:      Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the     apparition or the modification of vitiligo lesions with the past 3 months and under Wood's     lamp examination hypochromic borders and/or spotty depigmentation.      Interventions:      After central randomization        -  Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice          weekly narrowband UVB treatment for 6 months.        -  Arm B: with twice weekly narrowband UVB treatment for 6 months.      Evaluation:      Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease of     VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and biological     tolerance. Variation of CXCL10 levels in the serum.      Length of the study:      Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and drafting     the article: 6 months. Total length: 24 months.   "
65181|NCT02432521|"     The cerebrovascular accident (CVA) is currently the leading cause of death in Brazil and it     is estimated that there are about 62 million stroke survivors worldwide. Thus, the stroke     sequels are a major public health problem not only in Brazil but in the world, with existing     treatments often insufficient for complete recovery. Thus this study aims to identify     predictors of different responses from rehabilitation therapy through the evaluation of     clinical and neurophysiological data performed before and after treatment. For the     neurophysiological study will be used the association of electroencephalogram (EEG) and     transcranial magnetic stimulation (TMS). This last one will be performed in the baseline and     after a single Transcranial direct current stimulation (tDCS) session, aiming to leverage the     ability of those technics to analyze the cerebral plasticity. As a secondary objective: 1)     Identify specific features of brain plasticity involved in recovery from stroke and discuss     the possible implications of these findings in the therapeutic approach; 2) Search possible     electrophysiological markers that can be used as surrogate outcome of stroke of motor sequel.   "
65182|NCT02432508|"     Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality     of life of patients with chronic kidney disease undergoing hemodialysis. In order to     investigate the clinical efficacy and mechanism, the investigators designed a multiple     centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial.     This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of     CMUH.   "
65184|NCT02432482|"     The purpose of this study is to adapt an existing web-based tobacco treatment program for     HIV-infected smokers into a mobile intervention delivered via smartphone. After the     adaptation is completed, the investigators will test the program's efficacy at promoting     abstinence in a randomized controlled trial.   "
65186|NCT02432456|"     This study will evaluate the effectiveness of ketamine infusions in the management of acute     pain resulting from broken ribs suffered following a blunt trauma. Half of patients will     receive the institutional standard of care and a placebo infusion (no active medication). The     other half of patients will receive the institutional standard of care and a ketamine     infusion. All subjects and staff will be blinded as to whether they are receiving placebo or     ketamine.   "
65187|NCT02432443|"     Children begin to develop fundamental motor skills (FMS), such as running and kicking, and     pre-literacy skills, such as rhyming, during early childhood. These skills are very important     as they lay the foundation for more complex movements and literacy skill development later in     life, support overall healthy development in several areas, and help contribute to the     child's readiness for school. A child with strong motor skills is well equipped to lead a     life with healthy levels of physical activity, positive social interactions, positive     self-perceptions, and greater cognitive and language abilities. These skills will not develop     optimally on their own so it is essential to teach, challenge, and reinforce them at an early     age; often this learning takes place at home prior to entering school. Most research on this     topic has primarily focused on school-aged children or children with specific developmental     challenges and less is known about teaching motor and pre-literacy skills to young children     and giving parents the tools to practice these skills at home with their children. The aim of     the present study is to examine the effect of a motor and pre-literacy program, which     emphasizes parental involvement, on motor, pre-literacy, social skills, cognitive abilities,     and self-competence in 3 to 4 year old children with typical development.   "
65188|NCT02432430|"     Dissemination research examines the processes and factors that lead to widespread use of     evidence-based interventions. There are several theories on how to best minimize the     perceived and actual burdens on practitioners associated with implementing evidence-based     medicine. For instance, the pay for performance model attempts to improve physician     compliance with quality guidelines by providing financial incentives. Recent studies suggest     pay for performance is effective in improving practitioner performance, but it is unclear     whether the gains are sustainable once incentives are stopped.      Another approach to promoting best practices is the Model for Improvement whose main method     is to employ Plan-Do-Study-Act (PDSA) cycles of small changes Although this approach has been     successful within individual institutions, there is minimal evidence of its effect when     employed simultaneously in multiple autonomous institutions. There is also little evidence of     the sustainability of outcomes after intervention activities end.      The specific aims of the proposed study are to examine the effect of quality improvement     dissemination models on the immunization coverage of children ages 3 to 18 months old. The     investigators propose to:      1. Determine the effect on immunization compliance of two different models of dissemination     which will provide physicians 12 months of quality improvement (QI) activity support for     implementing CDC immunization best practices.      Hypothesis 1a: Study participants receiving the QI technical support intervention (QITS) will     have more improvement in immunization rates from baseline to immediately after support ends     than participants receiving the pay for performance intervention (P4P).      Hypothesis 1b: Study participants receiving QITS will increase immunization coverage for     their practices over baseline.      Hypothesis 1c: Study participants receiving P4P will increase immunization coverage for their     practices over baseline.   "
65189|NCT02432417|"     Glioblastomas (GBM) are the most common type of primary brain tumors with an annual incidence     of approximately 500 patients in the Netherlands. Despite extensive treatment including a     resection, radiation therapy and chemotherapy, the median overall survival is only 14.6     months.      Epidermal growth factor receptor (EGFR) amplification or mutation is regularly observed in     GBM and is thought to be a major contributor to resistance to radiotherapy and chemotherapy.     The most common EGFR mutation in GBM (EGFRvIII) is present in 30-50% of GBM.      Previously MAASTRO lab has shown that expression of EGFRvIII provides GBM cells with a     survival advantage when exposed to stress factors such as hypoxia and nutrient deprivation.     These metabolic stress factors activate a lysosomal degradation pathway, known as autophagy.     Inhibition of autophagy sensitizes cells to hypoxia, reduces the viable hypoxic fraction in     tumors with > 40% and subsequently sensitizes these tumors to irradiation.      Chloroquine (CQ) is a potent autophagy blocker and is the most widely investigated substance     in this context. Previously, the effect of CQ has been demonstrated in a small randomized     controlled trial in GBM treated with radiotherapy and carmustine. Although not statistically     significantly different, the rate of death over time was approximately half as large in     patients receiving CQ as in patients receiving placebo. The intracellular effects of CQ are     dose-dependent. Therefore, the authors suggest an increase in daily dose of CQ may be     necessary. Furthermore, the combination of CQ with TMZ may induce more damage to the     neoplastic cells.      In the phase I part of this trial the recommended dose of CQ in combination with radiotherapy     and temozolomide will be tested. In the phase II part of the trial patients with a     histologically confirmed GBM will be randomized between standard treatment consisting of     concurrent radiotherapy with temozolomide and adjuvant temozolomide (arm A) and standard     treatment plus CQ (arm B).   "
65190|NCT02432404|"     To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1     week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR     use among women either with BV or at high risk for BV. The investigators will also recruit     women who are HSV2-infected.   "
65191|NCT02432391|"     The purpose of this study is to determine if a lifestyle modification program (GEM) that     focuses on reducing after-meal blood glucose elevations can improve blood glucose control in     people with type 2 diabetes. Half of the participants will continue their routine medical     care, and half will receive five sessions of GEM in addition to their routine care. The two     groups will be assessed using diabetes-relevant medical, behavioral and psychological     measures.   "
65192|NCT02432378|"     The main goal of this research study is to determine if intraperitoneal (IP) administration     of cisplatin in addition to an investigational vaccine (the DC vaccine) with or without an     investigational drug combination of IP rintatolimod, IP interferon alpha-2b (IFN), and oral     celecoxib, has any effect, good or bad, on recurrent ovarian cancer.   "
65193|NCT02432365|"     The purpose was to establish a quick (7-day) cycle schedule of paclitaxel (60 mg/m2)     combining with cisplatin (40 mg/m2) NAC regimen could be tolerated without interfering the     following surgical treatment and a favorable overall survival rate for stages IB2 and IIA2     cervical squamous cell carcinoma (SCC).   "
71926|NCT02344303|"     Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and     supratherapeutic doses.   "
65195|NCT02432339|"     The purpose of this study is to determine if stopping the stress induced increase in     inflammation will prevent sodium retention which in turn increases blood pressure. Each     subject will test two separate times. One week, they will be taking a daily dose of     mycophenolate mofetil (MMF), the other week they will be taking a placebo.   "
65196|NCT02432326|"     This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally     in combination to patients with advanced solid tumors. The primary goal is to determine the     safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.   "
65197|NCT02432313|"     Parts 1 and 2:      Subjects take 1 dose of various formulations of the study product, and provide samples for     pharmacokinetic (PK) analysis after each, with at least 7 days between doses.      Part 3:      Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and     provides samples for PK analysis.   "
65198|NCT02432300|"     The purpose of this study is to examine a web-based training program for treating emotional     problems in people who have suffered a traumatic brain injury (TBI).   "
65213|NCT02432105|"     The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to     tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).   "
65199|NCT02432287|"     Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known     beneficial effects on glucose metabolism. Evidence from animal models and in vitro studies     suggest that in addition to its effects on glucose metabolism, metformin may influence     metabolic and cellular processes associated with the development of age-related conditions,     such as inflammation, oxidative damage, diminished autophagy, cell senescence and apoptosis.     As such, metformin is of particular interest in clinical translational research in aging     since it may influence fundamental aging factors that underlie multiple age-related     conditions. The investigators therefore propose a pilot study to examine the effect of     metformin treatment on the biology of aging in humans. Namely, whether treatment with     metformin will restore the gene expression profile of older adults with impaired glucose     tolerance (IGT) to that of young healthy subjects.   "
65200|NCT02432274|"     This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib in     children and adolescents with refractory or relapsed solid malignancies and young adults with     Osteosarcoma.   "
65201|NCT02432261|"     This is a prospective, randomized, double-blinded, two-center trial to evaluate the     gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T     gel alone, for 28 days.   "
65202|NCT02432248|"     The purpose of this study is to investigate the effect of DHEA for treatment of subfertile     patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.   "
65203|NCT02432235|"     This study evaluates ADCT-301 in patients with relapsed/refractory Non-Hodgkin or Hodgkin     lymphoma. Patients will participate in a dose-escalation phase (Part 1) and receive     escalating doses of ADCT-301 every 3 weeks.      In Part 2 of the study, patients will receive a recommended dose of ADCT-301 every 3 weeks.   "
65204|NCT02432222|"     The study will use a randomized controlled trial to test the efficacy of two interventions     (visual arts and music) for individuals with dementia, focusing on dementia of the     Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or     retirement residences. Participants will be tested before and after the intervention on a     battery of cognitive, affective, and behavioural measures. They will be compared to a     waitlist control group who don't receive the intervention.      The purpose of our research is twofold: treatment of symptoms and improved quality of life     during disease progression in dementia. For the primary aim, the investigators are examining     the potential of arts interventions on declining functions in dementia (memory, mood, and     behavior) to investigate potential treatment effects. Secondly, quality of life will be     measured, with the aim of looking beyond disease progression to contribute to an overall     positive patient experience. Research has indicated the need for non-pharmacological     treatments to be used as a first line of action against dementia symptoms and development.     While, in best practice, pharmacological treatments should be used as a second-line approach.      Note: Music intervention dropped prior to study initiation.   "
65205|NCT02432209|"     A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification     program with tracked increased physical activity and weight loss (intensive) compared to     recommendations to tracking of increased physical activity alone with weight maintenance     (standard) in women with obesity and unexplained infertility. This 16 week period of     lifestyle modification will be followed by an open label empiric infertility treatment     regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene     citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG) and     intrauterine insemination (IUI).   "
65206|NCT02432196|"     This is a Prospective, Single Arm, Single Group Assignment, EU study to demonstrate the     feasibility and safety of the Harpoon Medical TSD-5 in subjects with degenerative MR   "
65207|NCT02432183|"     In this study the investigators will study the lung function and airway inflammation in elite     athletes starting at the elite sport school (age: 12-13 year) and the change in lung function     parameters and airway inflammation after 1 and 2 years at the elite sport school in     comparison to age-matched controls (exercising at a recreational level, <4 hours/week).   "
65208|NCT02432170|"     This study aims to compare digital tomosynthesis with radiography and weight-bearing CT as an     imaging technique to assess arthritis in the foot and ankle.   "
65209|NCT02432157|"     Subarachnoid hemorrhage (SAH) occurs after rupture of cerebral aneurysms. Treatment of SAH     focuses on avoiding medical complications including cerebral vasospasm, which may result in     limited circulation to the brain. Cerebral vasospasm, or thinning of the arteries of the     brain, is a feared complication that could potentially cause stroke and worst outcomes after     SAH. Hypertonic saline (HTS) is a compound that may be used to prevent vasospasm following     SAH by enhancing the circulation in the brain. This study will evaluate if a protocol of     volume expansion with HTS is safe and effective in patients with subarachnoid hemorrhage for     the prevention of cerebral vasospasm.   "
65210|NCT02432144|"     UX003-CL202 is an open-label, multi-center extension study to assess long-term safety and     efficacy of UX003 treatment in patients with MPS 7.   "
65756|NCT02424994|"     The aim of this project is to study the association of a number of demographic and     cardiovascular risk factors with death, health care utilisation and systemic embolisation by     examining the clinical evolution of hypertrophic cardiomyopathy in a large, community based     cohort identified from linked electronic health records.   "
65211|NCT02432131|"     The investigators will prospectively estimate incidences of decompression sickness in SCUBA     divers with or without patent foramen ovale (PFO). All participants will receive     transesophageal echocardiogram and transcranial doppler to ascertain whether they get a PFO.     Clinical follow up will be undertaken 3 month after transesophageal echocardiographic     evaluation, and every 6 month up to 3 years by E-mailing or telephone interview with     self-questionnaire report. All decompression sickness (DC) events or DC-like symptoms will be     reviewed by a professional diver, who is a medical doctor and member of DAN-AP, and a     neurologist.   "
65212|NCT02432118|"     This pilot clinical trial studies the use of the radiofrequency-guided localization in     patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing     surgery). The radiofrequency identification localization system consists of an implantable     radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal     breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided     localization may make it easier to find and remove abnormal breast tissue during lumpectomy.   "
65214|NCT02432092|"     The goal of this protocol is to obtain information from individuals with cardiomyopathy and     from their families in order to elucidate the molecular genetics of this disorder. This will     provide the basis for future genetic counseling as well as contribute to elucidating the     biology of normal and abnormal cardiac function.   "
65215|NCT02432079|"     The goal of this study is to obtain specimens and data from individuals and their families     with heterotaxy and related congenital heart defects in order to clarify the molecular     genetics of this disorder. The knowledge gained from the analysis of this information will     provide the basis for future genetic counseling as well as contribute to knowledge about the     biology of normal and abnormal development of left-right anatomic asymmetry.   "
65216|NCT02432066|"     Attempts to quit cigarette smoking are often accompanied by negative mood and problems in     attention and memory. These effects, in turn, may contribute to smoking relapse. This     exploratory/developmental project examines the effects of a novel medication, GTS-21, on     individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce     negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and     women who are chronic cigarette smokers.   "
65217|NCT02432053|"     The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in     adult population undergoing kidney or liver transplantation in India.   "
65218|NCT02432040|"     This study aimed to assess the efficacy and safety of atorvastatin 40 mg/day as an adjunct to     betamethasone valerate 0.1% ointment applied twice daily in the treatment of patients with     mild to moderate chronic plaque type psoriasis, as determined by mean reduction in PASI     scores. Specific objectives included the determination and comparison of the absolute number     and proportion of patients who achieved PASI-50 and the mean reductions in lipid profile     (total cholesterol, HDL, LDL, triglycerides) and high-sensitivity C-reactive protein (hsCRP)     measured from baseline and every month thereafter up to 6 months of treatment. This study     also investigated the impact of atorvastatin treatment on the patients' quality of life as     well as the association of clinical response to the lipid-lowering and anti-inflammatory     effects of atorvastatin.   "
65219|NCT02432027|"     Evaluate the effects of topical C-82 in a psoriasis plaque test.   "
65220|NCT02432014|"     The purpose of this study is to gain a better understanding of family preferences for and     engagement in services.   "
65221|NCT02432001|"     The purpose of this study is to better understand how cancer treatment may affect cancer     cells. The research will involve genetic, molecular, cellular, and immunologic experiments     using blood and tumor specimens. It is hoped that the information gained from these studies     will lead to a greater understanding of castrate-resistant prostate cancer and potentially,     improvements in cancer treatment.      This is a tissue collection protocol requiring image-guided biopsies of metastatic,     castration-resistant prostate cancer (mCRPC). The investigators will focus on enrolling     patients with metastatic CRPC who have progressed while receiving novel AR-targeted     therapeutics such as abiraterone and enzalutamide. This population of patients was selected     because resistance develops relatively rapidly following potent inhibitors of AR activity and     the mechanisms of resistance have to be better understood. Without comprehensive analysis of     mCRPC tumor, the investigators will never gain a full understanding of the biology driving     resistance in human disease and developing rational co-targeting approaches will not be     possible.   "
65222|NCT02431988|"     The purpose of this study is to administer novel cluster of differentiation antigen 19 (CD19)     specific Chimeric Antigen Receptor T-cells (CAR19 T-cells) to patients with relapsed or     resistant Diffuse Large B Cell Lymphoma (DLBCL) to assess the safety and efficacy of this     strategy as a bridge to allogeneic transplantation.   "
65223|NCT02431975|"     The investigators propose a non-randomized clinical trial of 60 HIV-infected infants     identified within 48 hours of birth and their mothers to investigate the consequences of very     early ART on the establishment and maintenance of the viral reservoir.      The first phase (early ART initiation within 48 hours of birth) will examine the trajectory     i.e. changes over time of the viral reservoir and detection of HIV-specific antibody     responses in infants testing HIV-positive within 48 hours of birth and initiating early ART.      Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are     associated with the extent of seeding and rate of decline of the viral reservoir when ART is     started at a young age and investigate whether markers in infant stool samples can be used as     a non-invasive method of defining relevant immune and HIV-specific parameters associated with     viral reservoir size.      The investigators hypothesize that developmental characteristics of newborn immunity may make     this period the optimal time to begin ART and influence the seeding of the viral reservoir.   "
65386|NCT02429817|"     Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in     routine use in intensive care unit. However, jet nebulizers remain the most frequently used     nebulizers.      On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased     using a vibrating-mesh nebulizer as compared to a jet nebulizer.      Lung distribution of nebulized particles delivered through a HFNC has never been investigated     in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers     through a HFNC by SPECT-CT.   "
65224|NCT02431962|"     Lung cancer is the leading cause of cancer death in North America and in the world. The vast     majority of lung cancers are associated with cigarette smoking. Unfortunately, the majority     of lung cancers are detected at an advanced stage when they have a very poor prognosis. A     substantial amount of data has been reported on low-dose computed tomography (LDCT)     screening. Yet endorsement of lung cancer screening has not been universal because of     outstanding concerns which need to be addressed. Our study will aim to screen at risk     Albertans for lung cancer with LDCT scan at baseline, year 1 and year 2 while attempting to     fill some knowledge gaps on this topic.   "
65318|NCT02430740|"     The study objective is to develop a tailored based strategy for ovarian stimulation in IVF     patients using AMH, BMI, antral follicle count (AFC).      300 patients will be randomized in 2 arms:        1. control group: standard care rec FSH.        2. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI          and basal AMH level.      Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of     rec FSH used.      Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B     and AMH levels during ovarian stimulation.   "
65225|NCT02431949|"     The perception of music requires coordinated neural activities in distributed     multi-functional centers across both hemispheres. The association between musical abilities     and other general cognitive functions have been studied in several populations with     inconsistent results.      Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits.     These often appear before the onset of psychotic symptoms and persist throughout effective     treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia     features general deficits in auditory memory and sensory processing. Recently, Sawada et al.     (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic     populations. They both used a standardized assessment for amusia called Montreal Battery of     Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour,     interval, rhythm, meter and memory. Both studies showed that deficits in music perception     were associated with cognitive deficits and negative symptoms. In regards to positive     symptoms, Wen et al., but not Sawada et al., found a significant association.      The present clinical study will assess musical abilities using the MBEA in a Canadian     population with and without refractory psychosis. It will explore associations between     musical deficits, positive and negative psychiatric symptomology and cognition. The patient     population will have a diagnosis of schizophrenia, schizoaffective disorder, affective     disorder with psychosis or non substance-related psychosis who were referred to the British     Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of     antipsychotics. A focus on refractory psychosis may provide greater insights because these     patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will     also be valuable to administer the MBEA assessment on a Canadian population, because the test     was originally intended for Western populations and its musical phrases were designed with     Western tonalities.   "
65226|NCT02431936|"     High blood pressure, or hypertension, is a serious problem in the African-American (AA)     population which affects nearly 7 of every 10 AAs in our area. Previously the investigators     showed that a significant number of AAs held onto or retained salt during mental stress     (sodium retainers). The investigators believe that the increased salt load and resulting     blood pressure load contributes to the eventual development of hypertension in these     individuals. The purpose of this study is to find out if this response is due to the direct     stimulation of the kidney (the organ that controls salt levels in the body, by the brain). To     do this, the investigators will determine if a drug that stops the connection between the     brain and the kidney during mental stress will prevent sodium retention in sodium retainers.     Prazosin is an alpha adrenergic receptor blocker that has been approved by the Food and Drug     Administration (FDA). None of the subjects who participate in this study have high blood     pressure. The subjects will not know which testing week is the drug week and which is the     placebo week.   "
65227|NCT02431923|"     Background:      - Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects.     Researchers want to learn what ill health conditions Ebola survivors have. They want to learn     if Ebola survivors can infect others in their household through close contact. They also want     to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they     want to follow people in Liberia for 5 years.      Objectives:      - To learn how Ebola affects the health of survivors and the people they live with.      Eligibility:      - People in Liberia who had Ebola in the past 2 years, who share a household with someone who     had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because they     did not have Ebola.      Design:        -  Participants will be screened with family illness history, physical exam, and blood          tests. They may have an eye exam.        -  Ebola survivors and those who went to a Treatment Unit but did not have Ebola will visit          a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit, they          will repeat the screening tests.        -  Participants who live with someone who had Ebola will have only the screening visit. But          they may be asked to return for follow-up visits. These visits will help researchers          learn more about the differences between those who have had Ebola and those who have          not.        -  Participants brought to the NIH Clinical Center will have documentation of positive          Ebola virus PCR and a clinical syndrome compatible with acute EVD.        -  The study will last 5 years.   "
65228|NCT02431910|"     The purpose of this study is analyze the immediate and late effects of the application of KT     in neuromuscular performance of the quadriceps in postural balance and function of the lower     limb of healthy subjects.   "
65229|NCT02431897|"     This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning     native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued     postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic     science investigation are designed to understand the mechanisms by which local estrogen     treatment affects connective tissues of the pelvic floor and determine whether its use before     and after prolapse repair will (i) improve success rates of the surgical intervention and     minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor     disorders.   "
65230|NCT02431884|"     The purpose of this study is to collect a portion of blood/tissue specimens that will be     generated during the participants office visit or surgery. The investigators are asking     whether a small portion of the specimen/s could be set aside and banked for future research     purposes. Data originating from participants will be gathered and analyzed in research     studies that will help understanding various medical conditions such as polycystic ovary     syndrome (PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and     infertility.   "
65231|NCT02431871|"     The aim of this study is to assess long term effects of developmental dysplasia of the hip     (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip     symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170     children and young adults treated for DDH in their childhood with age and sex matched     controls.   "
65232|NCT02431858|"     To randomize 108 patients undergoing knee replacement surgery to catheter through needle or     catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if     there is a difference.   "
65233|NCT02431845|"     The purpose of this study is to determine whether pharmacogenetic study predict selective     serotonin reuptake inhibitor (SSRI) responsiveness in advance before the appearance of the     drug effect until 4 months(16 weeks), 6 months, and 1 year after administration of SSRIs.   "
65314|NCT02430792|"     Prostate cancer is the most common malignancy in men. Three million are currently living in     the United States with the disease and this number is expected to rise to four million in     2024. Most live many years with the disease and experience significant morbidity both due to     disease progression and treatment toxicity. Exercise has shown to improve QoL and reduce     treatment toxicity. Moreover epidemiological evidence has suggested that physical activity     improves survival.      Football has been shown to induce positive effects on body composition and bone markers in a     subgroup of prostate cancer patients, those receiving androgen deprivation therapy.      The objective is to examine the effectiveness of football in prostate cancer survivors.   "
65235|NCT02431819|"     Elastic compression stockings are recommended in the treatment venous insufficiency.     Degressive compressive stockings have been used for many decades and are characterized by a     high pressure applied at the ankle and a decreasing pressure from the ankle to the knee.     Progressive compressive stockings were developed to have a maximal pressure at the calf. This     concept is based on the calf pump role in the venous return. Patients with PAD (Peripheral     Arterial Disease) often suffer from venous insufficiency. But elastic compression stockings     are strictly contraindicated for patients with PAD because highest pressures on ankle could     slow down the superficial microcirculation.      On patients with PAD and venous insufficiency, the progressive compressive stockings could be     well indicated. Strongest pressure at the calf should increase the pump effect and the muscle     mechanical efficiency during the walk without deleterious effect.   "
65236|NCT02431806|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of     levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major     Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK)     data to guide dose selection for future pediatric studies of levomilnacipran.   "
65237|NCT02431793|"     The purpose of this study is to test the effectiveness of an electronic health record based     strategy in promoting safe use of opioid medications after an Emergency Department visit. The     EHR-based strategy was designed to enhance provider counseling about opioids and to     standardize and simplify the information that patients receive.   "
65238|NCT02431780|"     The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical     investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition,     the ANSER Software system.   "
65239|NCT02431767|"     The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and     interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM)     injection with electroporation (EP), in healthy, HIV-uninfected adults.   "
65240|NCT02431754|"     The main purpose of this study is to evaluate the safety and efficacy of the study drug known     as tadalafil in participants with benign prostatic hyperplasia who are being treated with an     alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or     placebo in each treatment period.   "
65241|NCT02431741|"     This is a prospective, open, non-controlled clinical investigation to evaluate the     performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten     to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant     (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant     (fungating) wound selected as a study site. Subjects will be followed for a one-week     observation period with their existing product followed by a 4-week investigation period     using Mepilex Transfer Ag.   "
65242|NCT02431728|"     Individuals recovering from drug and/or alcohol addiction initially experience the symptoms     of acute withdrawal before experiencing the symptoms of post-acute withdrawal (PAWS). PAWS     include a wide array of emotional and psychological symptoms such as anxiety, sleep     disturbances, depression, and stress. Previous studies have shown that melatonin therapy was     beneficial to alleviate anxiety, depressive symptoms, and sleep disturbances. However, no     randomized, double-blind, placebo controlled trials have been conducted in males who are     experiencing PAWS. The purpose of this study is to investigate the effect of 5 mg melatonin     given nightly for four weeks on weekly assessed, self-reported anxiety, depressive symptoms,     insomnia, and stress in males with PAWS who reside in a residential treatment center.   "
65243|NCT02431715|"     Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the     gastroenteropancreatic tract. They are usually slow growing, have low malignant potential,     and often go unnoticed until they become metastatic. The correct treatment approach is     dependent on the extent of the disease, however surgical approaches and systemic therapy can     be curative.      Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer     18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising     non-invasive technique to help localizing NETs and guide their treatment.   "
65244|NCT02431702|"     The purpose of the study is to compare effectiveness of paliperidone palmitate (PP:     paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP     [that is oral paliperidone extended release {ER}, oral risperidone, or another OAP]) in     delaying time to treatment failure. The study will also evaluate changes in cognition,     functioning, brain intracortical myelin (ICM) volume following treatment with PP compared     with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.   "
65245|NCT02431689|"     Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the     current study the investigators will attempt to compare antagonist and short protocols     regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be     performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still     implantation and pregnancy rates are considered secondary outcomes.   "
65246|NCT02431676|"     This is a prospective, single-center randomized trial with three arms, and an allocation     ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and     coach-directed behavioral weight loss versus self-directed weight loss on IGF-1 and IGF-1 to     THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed     Behavioral Weight Loss arm is a web-based remote delivery and communication system that     promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of     oral metformin. This is a secondary prevention study for men and women who have survived     solid malignant tumors   "
65247|NCT02431663|"     To evaluate the efficacy of intravenous administration of ketamine in the treatment of     refractory convulsive status epilepticus in children compared to administration of midazolam     at high doses, thiopental and / or propofol.   "
65299|NCT02430987|"     OBJECTIVE: To evaluate the prevalence of metabolic syndrome in postmenopausal women with a     diagnosis of Hypoactive Sexual Desire Disorder. CASUISTIC AND METHODS: This is a case-control     study in postmenopausal women attend in Menopause Clinic of the Faculty of Medical Sciences     of Santa Casa de São Paulo. The investigators will select women diagnosed with HSDD. All     women will sign the Consentment term. Those selected will assess the prevalence of MS through     the ATPIII criteria. Sexual function are assessed by questionnaire Female Sexual Function     Index (FSFI). RESULTS: The investigators hope there is greater prevalence of MS in women     after menopause with HSDD.   "
65248|NCT02431650|"     This is a single-centre, controlled, open label study using P. falciparum-induced blood stage     malaria (IBSM) infection to assess the effectiveness of OZ439 as a gametocytocidal agent, as     well as its treatment effects on gametocyte infectivity and development in vector mosquitoes.     Previous clinical studies including one IBSM study have shown that in addition to effectively     clearing replicating, asexual (pathogenic) life cycle stages of malaria, a single dose of     piperaquine (480 mg) results in the production of gametocytes, as determined by     gametocyte-specific transcript (pfs25) qPCR. The propensity of piperaquine to induce     gametocytaemia will be employed in this study to assess the efficacy of OZ439 as a     gametocytocidal and transmission blocking agent. Experimental mosquito feeding via both     direct feeding on participants and artificial (indirect) membrane mosquito feeding will be     performed. The study will be conducted in up to 3 cohorts where participants will be     randomised into an experimental or a control group (n=2 per group) when peak gametocytemia     occurs (approximately 15 days after administration of piperaquine).   "
65249|NCT02431637|"     This is a single-centre, open-label study using P. falciparum-induced blood stage malaria     (IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria     parasite (gametocytes) to mosquito vectors. Previous clinical studies have shown that     treatment of participants with the antimalarial drug piperaquine, in addition to effectively     clearing asexual (pathogenic) stages of the malaria life cycle, induces the production of     gametocytes in the blood. The propensity of piperaquine to induce gametocytemia will be     employed in this study to assess gametocyte infectivity to Anopheles mosquitoes. For this     purpose, experimental mosquito feeding directly on participants and artificial membrane     mosquito feeding will be performed. The study will be conducted in 3 cohorts (n=2 per     cohort). Subsequent cohorts will not commence until at least after day 28 of the previous     cohort and review by Safety Review Team. This interval will also allow cohorting of     experimental infection of mosquitoes to optimise logistics and enable iterative improvements     in the system if applicable.   "
65250|NCT02431624|"     The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.   "
65251|NCT02431611|"     Phase 3 Pilot Clinical Trial.   "
65252|NCT02431598|"     The purpose of this study is to evaluate changes in volunteer breath-holding capacity in     response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate     dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These     subjects will be given three, blinded, randomized injections while undergoing an MRI of their     liver and holding their breath. During the scan, the subjects' oxygen saturation and heart     rate will be closely monitored. Following the scan, the subjects will complete a     questionnaire regarding the breath hold.   "
65253|NCT02431585|"     Recently a new clinical entity, gluten sensitivity (GS), a form of gluten intolerance in     which neither allergic nor autoimmune mechanisms can be identified, has been added to the     spectrum of gluten-related disorders. This condition is characterized by gastrointestinal and     extra-intestinal symptoms including abdominal pain (68%); eczema or rash (40%); headache     (35%); diarrhoea (33%) and fatigue (33%). The small intestine of GS patient is usually     normal. The prevalence of GS is not yet established although it is estimated that up to 6% of     the general population might be affected. GS has been described only in adults and no data     are available for the paediatric population.The main problem with this new condition is that,     at present, there are no speciﬁc biomarkers to conﬁrm GS diagnosis. In the absence of a     serological or histological marker, the diagnosis remains clinical. In order to avoid placebo     effect of the dietary treatment, presently GS diagnosis needs to performed with double-blind     randomized placebo-controlled challenge provided that both wheat allergy and CD have     previously been excluded.      The primary aim of the study is to evaluate the prevalence of GS in IBS paediatric patients.      The secondary aims are: 1) to describe clinical, serologic, genetic and histological profile     of GS patient and 2) to study the role of gluten or other possible wheat components in the     onset of GS.      Study design Randomized double blind placebo controlled cross over re-challenge trial.     Patient consecutively diagnosed as having IBS (Rome III criteria) in whom the diagnosis of     coeliac disease and wheat allergy has been excluded, will be considered eligible for the     study.      Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA     and/or EMA and of Skin Prick Test, RAST immuno-CAP and Atopy patch test respectively.      Patients will entered a three-phase study with a running in phase (phase I: weeks 1-2),     diagnostic elimination diet phase (phase II: week 3-4) and re-challenge phase (phase III:     week 5-12)   "
65254|NCT02431572|"     This research study is studying the changes in primary and metastatic brain tumor     inflammation using positron emission tomography (PET) imaging using a radioactive substance     called [11C] PBR28a, which is also known as peripheral benzodiazepine receptors (PBR), or     PBR-PET.   "
65255|NCT02431559|"     This is an open-label, non‐randomized, multicenter Phase 1/2 study of MEDI4736 in subjects     with recurrent, platinum-resistant ovarian cancer, scheduled to receive Pegylated Liposomal     Doxorubicin (PLD). Subjects will be treated during each 28-day cycle according to the     treatment schedule.   "
65256|NCT02431546|"     The purpose of this study is to understand the effects of a mobile health cardiovascular     prevention program in patients who have recently graduated from cardiac rehabilitation. The     mobile health program will focus on promoting healthy lifestyles through the use of a mobile     application (app), mobile physical activity monitor and a system of remote health coaching.      By testing a novel mHealth intervention focused on lifestyle modification, this trial will     address a critical evidence gap in the care of patients after they graduate from CR. Many     patients who graduate from traditional CR struggle with unhealthy lifestyles, and these     patients currently have no lifestyle-based care strategies to help them. The results of this     study have the potential to lead to new sustainable and resource-efficient, lifestyle-based     preventive care strategies for patients with stable CVD.   "
65257|NCT02431533|"     IBS is a disorder of movement in the gut. People who have IBS may have diarrhea,     constipation, or alternating bouts of both. IBS is not caused by injury or illness. Often the     only way doctors can diagnose it is to rule out other conditions through testing.   "
65258|NCT02431520|"     A study to investigate the compliance of unassisted women to self-collection of specimens for     Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear     collection by medical personnel, as screening method to identify precursor lesions of     cervical cancer.   "
65259|NCT02431507|"     The purpose of this study is to determine the safety and feasibility of the Magnap magnetic     device in the treatment of obstructive sleep apnea (OSA).   "
65300|NCT02430974|"     Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with     non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine     kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the     efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection     of stage IB to IIIA EGFR-mutated NSCLC.   "
65260|NCT02431494|"     Acne vulgaris is a multifactorial, highly prevalent dermatologic condition that results in     visible lesions that can be quite disfiguring. Consequently, individuals with acne often     suffer from a wide range of psychological manifestations. Although there is consensus that     combination therapy is most effective in treating acne, researchers are constantly striving     to develop new treatment. Microcurrent therapy (MCT) is a non-invasive modality that has     successfully been used to promote wound healing and has been routinely used in aesthetics.     Use of MCT alone or in combination with current successful treatment such as blue light     phototherapy (BLP), may hold promise for acne treatment. The investigators propose to conduct     a small randomized control trial to determine the safety and preliminary efficacy of a novel     combination therapy to treat acne vulgaris. The investigators will recruit up to 60 males and     females and randomly assign them to one of 3 arms: 1) BLP; 2) MCT; and combination therapy     (BLP and MCT). The investigators will assess physiological parameters (number of acne     lesions, amount of sebum produced, degree of acne severity) and psychosocial factors     (dermatologic quality of life, social anxiety, depressive symptomatology, self-esteem).     Participants will complete a baseline assessment prior to initiating treatment and a     follow-up assessment at 4 weeks post termination of treatment. The investigators will conduct     intermediary assessments at weeks 3 and 5 and 1 week post termination of the treatment. The     investigators will use measures of central tendency to describe the sample and repeated     measures analysis of variance to compute the main and interaction effects.   "
65261|NCT02431481|"     The purpose of this study is to characterize the PK and safety profile of LEE011 following a     single oral dose in adult subjects with various degrees of renal impairment compared to a     matched group of healthy subjects with normal renal function.   "
65262|NCT02431468|"     This is a randomized double-blind placebo-controlled study comparing different doses of     bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study is     15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose     of study drug.   "
65263|NCT02431455|"     This study evaluates the omission of incentive spirometry use following bariatric surgery.     Half of participants will receive an incentive spirometer while the other half will not.     Oxygen saturation and pulmonary complications after surgery will be measured to examine the     effectiveness of incentive spirometry.   "
65264|NCT02431442|"     The purpose of this study is to evaluate the multiple dose safety and tolerability of RM-493     (setmelanotide) as well as pharmacokinetic (PK) and pharmacodynamic (PD; weight loss)     profile, in healthy obese patients for 2 to 4 weeks. In addition, one panel of patients with     a specific genetic deficiency in the hypothalamic leptin- proopiomelanocortin (POMC) -     melanocortin-4 receptor (MC4R) pathway, those with heterozygous partial or full loss of     function (LOF) of the MC4R gene, will also be studied. The study drug (RM-493 and placebo)     will be administered subcutaneously in a blinded fashion by subcutaneous (SC) infusion or     injection.   "
65265|NCT02431429|"     This study is a Phase 4, open-label, single group study in which at least 55 evaluable adult     male patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will provide     semen samples for spermiogram analysis of sperm parameters.   "
65266|NCT02431416|"     The purposes of the study is to investigate whether circulating levels of ghrelin decreases     after an iv injection of GnRH in girls with suspected central premature puberty and to     investigate the effects of different post sampling handling on the preservation of acylated     ghrelin.   "
65267|NCT02431403|"     Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage     therapy in relapsed/refractory non-Hodgkin's lymphoma   "
65268|NCT02431390|"     This study is to investigate whether the RAPAELⓇ Smart Glove digital treatment system     improves the upper extremity function of stroke patients compared to other clinical treatment     by measuring serial behavioral and neuroimaging assessments and to find out therapeutic     effect or adverse effect and patient's feed back responses   "
65269|NCT02431377|"     A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of     the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin     (WPC alpha-lac) fed for 6 weeks to healthy, term infants.   "
65270|NCT02431364|"     This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate     the safety and tolerability of verdinexor. Verdinexor or placebo will be given on days 1 and     3 to healthy adult subjects.   "
65271|NCT02431351|"     This is an open-label study designed to evaluate the safety and efficacy of the selective     inhibitor of nuclear export (SINE) compound, Selinexor given orally to patients with     transfusion-dependent, EPO-refractory lower-risk MDS (Low risk and Intermediate-1 as defined     by IPSS).   "
65272|NCT02431338|"     The aim of this study is to investigate the cost-effectiveness of remote ischemic     conditioning as an adjunct to primary percutaneous coronary intervention from the perspective     of a Danish healthcare system.   "
65273|NCT02431325|"     The purpose of this research study is to determine whether teduglutide can repair a leaky     gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other     materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to     inflammatory changes and leakiness of the gut. These changes or conditions may increase the     risk of developing heart and blood vessel disease. The investigators believe teduglutide can     help repair the gut barrier in people with HIV, leading to a decrease in inflammation and     plaque in the blood vessels of the heart.   "
65274|NCT02431312|"     This is an open-label study to evaluate the safety, tolerability, and immunogenicity of dose     combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid     encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide     analogue treated patients.   "
65313|NCT02430805|"     This project aims at investigating the genetic, genomic and proteomic basis of hypertension     and susceptibility to hypertension-related end organ damage (renal damage and heart failure).     It will include cross sectional as well as follow-up studies with a large number of subjects     and variety of phenotypes, to explore the pathophysiology of hypertension and     hypertension-related disease.   "
65757|NCT02424981|"     Efficiency of inspiratory muscle training in elderly people. Outcomes are lung function,     muscle strength and chest expansion.   "
65275|NCT02431299|"     Illness Management and Recovery (IMR) is an evidenced-based approach to teaching consumers     with severe mental illness how to set and achieve personal recovery goals and acquire the     knowledge and skills to independently manage their illnesses. Longitudinal, multi-site, and     randomized controlled trials have shown IMR to be effective in increasing illness     self-management and coping; some evidence also points to reduced hospitalization rates.     Fidelity, or adherence to a specific treatment model, is equally important to both clinical     research and to the practical dissemination of evidence-based practices to the field.      To this end, the research team has developed an IMR clinician-level fidelity assessment, the     IMR Treatment Integrity Scale (IT-IS). However, the validity of the preliminary IT-IS has not     been rigorously evaluated. Additionally, it is crucial to develop strategies to utilize the     IT IS to increase adherence to the IMR model and ultimately increase consumer outcomes.      The purpose of this study is to assess the construct validity of the IT-IS by testing the     relationship between IT-IS elements and mechanisms of change and proximal outcomes. The     investigators will collect a sample of IMR session recordings and pre-post data from IMR     participants from recruitment sites in Indiana, New Jersey and several other states. The     investigators will test hypothesized relationships between specific program elements and     theoretically proposed mechanisms of change. The investigators will also assess     organizational and clinician factors affecting IMR competence by including a survey for the     staff members who are located as sites where the investigators have clinicians participating     in providing IMR.   "
65276|NCT02431286|"     The objective of this study is to investigate if aprepitant in association with palonosetron     and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom,     undergoing cancer surgery mastectomies.   "
65277|NCT02431273|"     This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a     sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate     (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following     drug combinations: 1) TDF (Single IVR); 2) TDF-FTC (Dual IVR) and; 3) TDF-FTC-MVC     (Triple IVR).   "
65278|NCT02431260|"     This is a study of INCB054329 given to patients with advanced malignancies that will be     conducted in three treatment groups. Each treatment group will have two parts; a dose     escalation (Part 1) and an expansion (Part 2).   "
65280|NCT02431234|"     The blood concentration of the protein RANKL could be predictive of the calcification of the     leg arteries, which is a major complication occurring during diabetes. The objective of the     DIACART study is to show that blood RANKL concentration predict the progression of     calcification of the leg arteries in diabetic patients, independently of other cardiovascular     risk factors.   "
65281|NCT02431221|"     A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with     Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure   "
65282|NCT02431208|"     This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and     pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various     immunomodulatory agents in participants with MM who have relapsed or who have undergone     autologous stem cell transplantation (ASCT). The planned duration of this study is     approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in     Cohorts D to F.   "
65283|NCT02431195|"     The main objective of this study is to identify changes in eating behaviors and physical     activity in patients after bariatric surgery and their family members living in same     household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a     civil union.   "
65284|NCT02431182|"     Randomized controlled trial to assess the effectiveness of a Memory Training Workshop in     cognitive function, in terms of self-perceived memory, everyday memory and executive control     abilities. It is expected that the group intervention of memory training that this study     proposes significantly improves cognition (memory, attention and executive control abilities)     and the quality of life related to health (HRQOL) in the Experimental Group (EG) compared to     the Control Group (CG). The group of individuals that take part in the Memory Training     Workshops (Experimental Group) will be compared to another group of similar characteristics     that do not (Control Group). Data will be collected at baseline, 3 months later and 6 months     later.   "
65285|NCT02431169|"     The investigators propose to conduct a pilot feasibility study of single agent erlotinib in     patients with metastatic EGFR mutant adenocarcinoma of the lung with up to one prior     treatment with the sole purpose of characterizing the genomic landscape before erlotinib and     at the time of disease progression. The logistics of obtaining adequate quality fresh tissue     specimens for sequencing studies before therapy and at the time of disease progression in     patients with advanced lung cancer are complex and a thorough understanding of the practical     challenges in conducting a study like this is crucial.      The current proposal will include exome and transcriptome sequencing from blood collected at     baseline along with tumor samples obtained prior to starting erlotinib and at the time of     disease progression (a total of two tissue samples and one blood sample per patient). If     carried out successfully, the proposed strategy very likely will lead to a larger and     adequately powered study to understand fully evolving molecular changes due to clonal     selection under treatment pressure. The pace of progress in the field of sequencing     technology currently underway is only likely to accelerate in the near future yielding richer     and highly content-rich information. Moreover, it is likely that genomic information from DNA     sequencing and transcriptome will be supplemented by analyses of translatomes and proteomes.      The investigators plan to sequence paired tumor specimens from 20 patients with EGFR mutant     adenocarcinoma of the lung before treatment with erlotinib and at the time of disease     progression following treatment with erlotinib. As the investigators expect some drop off     (due to unexpected clinical events precluding a second biopsy at the time of disease     progression, poor specimen quality and early discontinuation of therapy for non-progression),     the investigators will enroll 40 patients in this trial to get 20-paired specimens.   "
65286|NCT02431156|"     Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery for     presbyopia correction with monofocal intraocular lenses implantation are supposed to have     sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a)     distant vision(DV), (ie. driving), b) intermediate vision (IV), (ie. computer word     processing), c) near vision (NV), (ie. book reading). Primary objectives of the study are: 1)     the development of a series of tasks in a research setting that will simulate common ADLs     that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in     the research setting with demographic, clinical and other parameters of the study     participants.   "
65315|NCT02430779|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms.   "
65316|NCT02430766|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Lymph Node Metastases.   "
65287|NCT02431143|"     This is a multicenter, non-comparative, open-label clinical trial to assess the     Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the     treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy     and Pharmacodynamics (PD) will be assessed as secondary outcomes.      The proposed study aims to assess whether drug exposure in children can be increased to     equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28 days     in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present study is     also expected to provide the basis for minimum time to reach sufficient drug exposure for     miltefosine activity to guide optimal treatment duration to be used in combination therapy     for visceral leishmaniasis. The PK data will be assessed in this trial using a compartmental     population PK approach.   "
65288|NCT02431130|"     The goal of this study is to examine whether low‐fidelity instructor‐driven simulation can     provide effective teaching of anesthetists' non‐technical skills in a developing world     context. Human factors, such as communication, planning, and team working are considered     nontechnical skills which contribute greatly to patient safety in complex hazardous systems     such as aviation, nuclear power industry, and operating rooms. Simulation began in the     aviation industry to train pilots in human factors. In the past two decades simulation has     been valued in medical education as it allows the learner to rehearse skills in an     environment that is similar to the workplace but without the threat of harm to patients. High     Fidelity simulators involve computer driven interactive mannequins that recreate an authentic     environment. This has been used successfully to teach anesthetists' non‐technical skills     (ANTS) such as: decision making, team working, task management, and situation awareness.     Anesthetists' non‐technical skills are particularly important in developing countries where     the shortage of supplies, equipment, and qualified personnel can lead to a perilous working     environment making team work and communication vital for patient safety. The costs of high     fidelity simulation are prohibitive for many developing countries. This study seeks to     examine whether low fidelity instructor driven simulation can provide an effective     intervention to teach anesthetists' non‐technical skills in Rwanda. If found to be effective,     this method of training could be applied to other developing countries to improve     non‐technical skills for anesthesia providers with the goal of making surgery safer.   "
65289|NCT02431117|"     To evaluate the suitability (i.e. number of tests completed and number of participants     completing the tests, variance estimate of baseline and of the change from baseline values)     of neurocognitive tests and functioning scales in view of their use in future multicenter,     multinational clinical efficacy trials testing a putative cognitive enhancer for individuals     with Down syndrome aged 6-30.   "
65290|NCT02431104|"     A single-center prospective, open-label, uncontrolled study in 10 male or female subjects,     age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.   "
65291|NCT02431091|"     The purpose of this study is to determine the sensitivity and specificity of the use of     optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI     and usual cognitive screening tools.   "
65292|NCT02431078|"     The aim of this study was to investigate the expression of ZEB1 in CTCs for gastric cancer,     its correlation with the clinicopathology of gastric cancer, and the role of ZEB1 in invasion     and metastasis in gastric cancer.   "
65293|NCT02431065|"     Rectus sheath block is effective in reducing pain in the peri-umbilical region, and the use     of ultrasonography is recommended to perform the block at the precise location. Recently,     intra-operative rectus sheath block has also been introduced without the aid of     ultrasonography. However, no study has not yet compared the analgesic effects of these two     different approaches (ultrasonography-guided vs direct surgical). Thus, the aim of our study     is to compare the effect of ultrasonography-guided and direct-surgical rectus sheath block     after single-port access laparoscopy in benign ovary cyst patients.   "
65294|NCT02431052|"     The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared     to vehicle in patients with acne vulgaris.   "
65295|NCT02431039|"     This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine     diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of     intraoperative handling.   "
65296|NCT02431026|"     The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients     who were resuscitated following cardiac arrest but who remained comatose. Induced mild     hypothermia is now the standard of care for post-resuscitation patients in the intensive care     unit (ICU) setting. The use of cooling has recently moved to pre-hospital and emergency     department (ED) application as more current studies show that early initiation of cooling     significantly improves neurologic outcomes and survival rates instead of waiting until the     patient arrives in the ICU to initiate cooling. In the pre-hospital setting chilled saline     (4°C) and packing the body in ice have been the primary methods to initiate induced mild     hypothermia The Excel Cryo Cooling System is a non-invasive cervical collar (C-collar) that     provides cooling to the carotid arteries, the main blood supply to the brain, and allows for     the rapid initiation of selective cerebral cooling. The investigators are planning to use     MRI-thermometry to see how quickly the Excel Cryo Cooling Collar can drop brain temperature     when applied by itself.      Healthy volunteers will be used for this study to provide important temperature data on the     effectiveness of the Excel Cryo Cooling System. The investigators will be able to use the     data from this project to further the current clinical research in induced mild hypothermia     after cardiac arrest.   "
65297|NCT02431013|"     This is a randomized, open-label, single & multiple-dose, parallel study to investigate the     effect of cilostazol on the disposition of simvastatin & pravastatin in healthy male     volunteers   "
65298|NCT02431000|"     PURPOSE: Primary objective: To assess the feasibility and outcomes of male fertility     preservation by sperm freezing prior to starting treatment requiring alkylating agents and/or     total body irradiation.      Secondary objective: To assess pre- and post-treatment sperm production and hormonal status     by measurement of serum anti-mullerian hormone (AMH), inhibin-B, follicle stimulating hormone     (FSH), luteinizing hormone (LH), testosterone, and androstendione.   "
65357|NCT02430194|"     An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib With     Ritonavir Boosting in Patients Chronically Infected With Delta Hepatitis (HDV) (LOWR-2).   "
65301|NCT02430961|"     Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients     can donate tissue and organs following death after withdrawal of life sustaining therapies     (WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this is     a significant emotional and resource burden to families, healthcare workers and hospitals. A     tool that allows accurate prediction of time to death following WLST (and thus the     probability of successful donation) is urgently needed. Existing models have not been useful     due to the lack of generalizability. Additionally, existing models have not included other     important factors now recognized to be associated with time to death following WLST.      The investigators will conduct a prospective, observational cohort study of all patients     being considered for DCD in whom consent for donation is obtained to evaluate the association     between neurologic and non-neurologic risk factors for apnea, other clinically important     variables and time to death after WLST, and use these data to derive a generalizable     predictive model for the prediction of the time to death following WLST in potential DCD     donors.   "
65302|NCT02430948|"     The study hypothesis is that clearer visual presentation of guideline recommendations and     educational outreach, or academic detailing, can improve guideline compliance. However, it     will investigate other aspects of screening-related decision-making, such as provider and     patient beliefs about screening, provider-patient communication and patient's willingness to     forgo expected testing. The research question is whether educational interventions can     decrease non-compliance with screening guidelines for 5 common cancers.   "
65303|NCT02430935|"     The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for     early intervention as compared against an active control in which Action Based Cognitive     Remediation (ABCR) will be applied.   "
65304|NCT02430922|"     The objective of this clinical investigation is to evaluate the short-term (up to 12 months)     outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic     (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.   "
65305|NCT02430909|"     The purpose of this study is to evaluate the safety, efficacy and body distribution of     Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid     Arthritis. Neither the patient nor the doctor will know the treatment group.   "
65306|NCT02430896|"     The objective of this study is to identification of neuropsychological, genetic and     neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity     disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or     atomoxetine) for ADHD will be observed for 52 weeks. They will do several neuropsychological,     neuroimaging and genetic tests at visit 1~6.   "
65307|NCT02430883|"     We want to serach the relationship between the pain degree and stone localisation in kidney     in Retrograde intrarenal surgery   "
65308|NCT02430870|"     This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose     study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This     study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when     administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy     participants of Japanese decent and participants with T2DM.   "
65309|NCT02430857|"     This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in     patients with latent hypothyroidism.      One half of the participants will receive an osteopathic manuel treatment in order to     stimulate the relevant segments, the other half will receive no treatment.   "
65310|NCT02430844|"     Title: Role of biomarkers in predicting contrast-induced acute kidney injury in critically     ill patients: a prospective observational study      Objective: To analyse the role of plasma and urinary biomarkers (Neutrophil     Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in     predicting contrast-induced acute kidney injury (CI-AKI) in critically ill patients.      Summary of the project:      Acute deterioration of renal function after intravenous administration of radiocontrast     media, i.e. increase in serum creatinine concentration of more than 0.5 mg/dl or 25% above     baseline within 48 hours, is referred to as contrast-induced kidney injury (CI-AKI). The     increasing number of diagnostic procedures requiring radiographic contrast has parallel     increase in the incidence of CI-AKI. CI-AKI is described as the third most common cause of     new AKI in hospitalized patients. Occurrence of CI-AKI is reported up to 55% in high risk     patients like presence pre-existing chronic renal dysfunction, diabetes, hypertension,     chronic heart failure, advanced age, volume depletion, uses of concurrent nephrotoxic     medication. These risk factors for CI-AKI are common in critically ill patients. Recently,     different urinary and serum proteins have been intensively investigated as possible     biomarkers for the early diagnosis of AKI, which includes Neutrophil Gelatinase-Associated     Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1 (KIM 1). At present, there is     scarcity of prospective study on CI-AKI and role of biomarkers in critically ill medical or     medical-surgical mixed ICU patients.      The investigators plan to enroll about 100 ICU patients during 2 years, requiring computed     tomography (CT) scans with parenteral administration of iodinated radiographic contrast for     any diagnostic purposes as decided by the clinicians during the treatment of the patients. In     this prospective observation study, the investigators want to analyse the role of plasma and     urinary biomarkers in predicting CI-AKI in critically ill patients.      Key Words: acute kidney injury, radiographic contrast, critically ill, biomarker   "
65311|NCT02430831|"     Study type:      Randomized controlled trial with two parallel arms Objectives      Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula     containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary :     Evaluate the effects of daily supplementation of colicky infants with Nidina formula     containing L. reuteri DSM 17938 measured as        1. the number of responders or the treatment success (ie infants for which defined as          the percentage of children achieving a reduction in the daily average crying time >50%          in 3 weeks. (day 1 to day 21 of the study)        2. maternal depression and family functioning scoring   "
65312|NCT02430818|"     Opioid pain medications such as morphine and dilaudid are commonly used in emergency     departments to treat pain in patients. Physicians are familiar with the side effects of these     medications; the most concerning of which is slowing or stopping a patient's breathing, as     well as dangerously lowering their blood pressure. An alternative medication is ketamine.     This medication is also commonly used in the emergency department, although it is typically     used to help sedate patients for uncomfortable procedures. Ketamine has also been used for     pain control, but in a much lower dosage that does not sedate patients. When used for     analgesia, it has typically been administered in combination with opioid pain medications. To     date, there is no study that looks at the effectiveness and safety of using a low dose     ketamine alone in comparison to the use of morphine. The purpose of this study is to measure     how well low-dose ketamine treats pain compared to morphine and to look at how often serious     side effects are seen with each medication.   "
65358|NCT02430181|"     To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in     Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).   "
65319|NCT02430714|"     This study is a post-marketing surveillance of lenvatinib in participants with unresectable     thyroid cancer. The objectives of this study are to capture unknown adverse reactions,     incidences of adverse drug reaction, efficacy, factors considered to have effect to safety     and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic     event, and liver disorder.   "
65320|NCT02430701|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Esophageal Neoplasms.   "
65321|NCT02430688|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Extremities Neoplasms.   "
65322|NCT02430675|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Laryngeal Neoplasms.   "
65323|NCT02430662|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Gallbladder Neoplasms.   "
65324|NCT02430649|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Prostatic Neoplasms.   "
65325|NCT02430636|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Stomach Neoplasms.   "
65326|NCT02430623|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Urinary Bladder Neoplasms.   "
65327|NCT02430610|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Uterine Cervical Neoplasms.   "
65328|NCT02430597|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for Hilus Pumonis Neoplasms.   "
65329|NCT02430584|"     To obtain whole blood specimens from pregnant subjects to be used for research and     development and clinical validation studies of prenatal assays.   "
65330|NCT02430571|"     This is a prospective, single-center, open label, within-subject clinical trial to evaluate     the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding     tube. The trial will evaluate hospitalized subjects who require short-term enteral feeding     with an anticipated duration of at least 3 days while in an intensive care unit (ICU) or     step-down unit. Eligible men and women at least 18 years of age who give voluntary, written     informed consent to participate in the clinical investigation will be included as subjects.     If a potential subject is incapacitated and unable to provide informed consent, a designated     legally authorized representative will be allowed to provide the informed consent on behalf     of the subject to allow their participation in the study. Study entry will be defined as the     point of signed informed consent. A Prospective, Single-Center, Open Label, Within-Subject     Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal     Tract Using the KANGAROO™ Feeding Tube with IRIS Technology   "
65331|NCT02430558|"     Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not)     within > 18 months, with one or two osteochondral lesions are recruited to have treated     osteochondral allografts in mosaicplasty.   "
65332|NCT02430545|"     The study also aims to determine the effect of a strong enzyme (CYP3A4) inducer-rifampin- on     drug exposure of Glasdegib. This study will be conducted in healthy subjects given a single     dose of glasdegib in each period.   "
65333|NCT02430532|"     The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl     fumarate) compared with placebo slows the accumulation of disability not related to relapses     in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective     of the study is to assess the effect of BG00012 compared with placebo on patient-reported     outcomes, brain atrophy, and cognitive function.   "
65334|NCT02430519|"     Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an     area of complex anatomic morphology difficult to debride by routine periodontal     instrumentation. Multiple approaches have been used in an effort to treat the furcation     Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has     biochemical components which have well known synergetic effects on healing processes. The     present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin     (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to     allograft and guided tissue regeneration (GTR) membrane.   "
65359|NCT02430168|"     Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus     percutaneous nephrolithotomy in 2 to 4 cm kidney stones.   "
65335|NCT02430506|"     The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete     protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or     booster, while not toxic, does not provide much additional protection. AERAS-402 presents     tuberculosis antigens in the setting of a new, live, replication deficient adenovirus vaccine     that may increase T cell immunity and thus protection from tuberculosis. Since BCG-vaccinated     individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be     administered to individuals in Kenya who have already been vaccinated with BCG.   "
65336|NCT02430493|"     The primary objective is to describe the safety and tolerability of ticagrelor, by assessment     of adverse events (characteristics, reporting rate, severity, relationship and risk factors),     especially the bleeding events as defined in 8.1 and other serious adverse events (SAEs)     during 1-year follow up in Chinese acute coronary syndrome (ACS) patients.   "
65408|NCT02429531|"     Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency     characterized by a deficient antibody production to capsular polysaccharides with normal     total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections     and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting     other components of the immune system. Diagnosis of SPAD is hampered by difficulties with the     interpretation of the Pneumovax 23 antibody response. The purpose of this study is to assess     the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers as an     alternative to the Pneumovax 23 response to detect polysaccharide specific antibody     deficiency.   "
72494|NCT02336854|"     A randomized, open-label, two-way crossover study to assess the tolerability and     pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy     male volunteers.   "
65337|NCT02430480|"     Background:        -  There are several ways to treat prostate cancer. Researchers want to see how well a          certain kind of imaging helps detect prostate cancer. They also want to see if a          particular drug combination used before surgery will benefit people with prostate cancer          that hasn t spread in the body (non-metastatic). The combination will be androgen          deprivation therapy and enzalutamide.        -  The combination of androgen deprivation therapy and enzalutamide has been shown to make          patients with advanced (metastatic disease) live longer. The investigators want to see          if using it earlier can increase cure rate of surgery and identify genetic or molecular          characteristics that are associated with better outcomes.      Objectives:      - To develop better ways of detecting prostate cancer before and after pre-operative     treatment.      Eligibility:      - Men at least 18 years old with non-metastatic prostate cancer. They must be candidates for     a radical prostatectomy.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests. They          will have scans and X-rays.        -  Before starting the study drugs, participants will have:        -  Vital signs taken, medical history, and blood tests.        -  ECG heart test, with patches stuck on the skin.        -  Small piece of tumor removed (biopsy) using image guidance from MRI and ultrasound.        -  3T mpMRI. Participants will lie on a table that slides into a metal cylinder. A probe          will be inserted in the <TAB>rectum. They will be in the scanner for about 60 minutes,          lying still. The scanner makes loud knocking <TAB>sounds. Participants will get          earplugs.        -  Participants will take the 2 study drugs for 6 months.        -  Enzalutamide is taken as 4 pills once a day.        -  Androgen deprivation therapy is given by injection 2 times over 6 months.        -  During these 6 months, participants will visit the clinic monthly. They will have          physical exam, vital signs, and blood drawn.        -  After finishing the study drugs, participants will have another 3T mpMRI. Then they will          have prostate removal surgery.   "
65338|NCT02430467|"     The purpose of this study is to develop more effective ways to help patients and their     caregivers cope with cancer pain. The investigators are looking at the usefulness of a     Caregiver-Guided Pain Management Training Intervention versus Pain Education.   "
65339|NCT02430454|"     Decisions about ICU beds allocations are made everyday, specially in countries with scarcity     of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead     to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that     external factors may influence the decision making process. The investigators intend to     evaluate the impact of bed availability and cognitive load on the ICU bed allocation process     by submitting groups of individuals to a vignette based randomized controlled trial     simulating conditions with or without increased cognitive load and conditions with or without     scarcity of ICU beds.   "
65340|NCT02430428|"     The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl     Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or     elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or     without astigmatism) and MRSE ≤ -11.50 D.   "
65341|NCT02430415|"     The aim of the study is to compare the effect of the laryngoscope-assisted lightwand     intubation technique vs. the conventional lightwand intubation technique on the cervical     spine motion during intubation in patients with the simulated cervical immobilization.   "
65342|NCT02430402|"     Young patients with rheumatic diseases have challenges different from older patients due to     their life situation. It has been reported that they do not have the same benefit from age     non-specific rehabilitation in warm climate. This trial will test the effect of a specially     adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian     young adults aged 20-35 years.   "
65343|NCT02430389|"     To identify a better method using a combination of routine anesthetic drugs to improve     hemodynamic stability during Mayfield head pinning for craniotomy surgery.   "
65344|NCT02430376|"     Background:      Pentalogy of Cantrell (POC) is a syndrome that involves many heart abnormalities as well as     large defects in the chest and abdominal wall. This often results in the heart and other     organs being present outside the body at birth. Surgeons have learned to replace them and     repair the heart. Researchers want to find possible gene changes that cause POC. To do this,     they want to study data from the Pediatric Cardiovascular Genetics Consortium (PCGC) Cohort.     The PCGC collects data and DNA samples from people with heart diseases and their families      Objectives:      - To find gene mutations in people with Pentalogy of Cantrell (POC) or other related     syndromes.      Eligibility:      - PCGC data and DNA samples that are open to study by the public.      Design:        -  Researchers will study the data from the PCGC.        -  The gene testing being done in this study was consented to in the original studies. No          new consent or waiver request is required.        -  The study will last 1 year.   "
65345|NCT02430363|"     It is known that after application of MK-3475 activated PD -1 negatively regulates the     activation of T cells through suppression of the path of PI3K / Akt.      This study will identify the effectiveness of oral inhibitors of PI3K / Akt pathway in     comparison with MK-3475 (pembrolizumab).   "
65346|NCT02430350|"     The primary objective of the study is to confirm the efficacy of compound Edaravone Injection     via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a     double-blind, active-controlled manner. The study is also to examine the safety of compound     Edaravone Injection for the AIS patients.   "
65347|NCT02430337|"     In this study, a computer-assisted adaptation of SafeCare, an evidence-based home visiting     program, will be developed and tested in child welfare. This approach will assist home     visitors with delivery of SafeCare to families, with the goal of improving provider fidelity     and implementation success. In the computer-assisted SafeCare sessions, a portion of the     session will be delivered on a tablet computer that the home visitor brings to the family's     home. The computer software will deliver the educational piece, or explain piece of each     session, along with modeling videos of the skills. The home visitor will follow up with the     practice and feedback portions of the session. A randomized feasibility trial will be     conducted to test the technology-based approach against the standard SafeCare implementation     approach in terms of feasibility of implementation, provider job demands and resources, as     well as client outcomes such as skill acquisition and mental health.   "
65370|NCT02430025|"     This proposal delineates a research plan to collect blood from the patients with     cardiovascular diseases for the purpose of establishing a molecular biological bank registry.     The Fujian provincial hospital will enroll 8,000 patients.The blood collected will be     processed to create a repository of molecular biological plasma. Along with a sample of blood     collected from individual patients, a concise general medical history, demographic data,     electrocardiographic data, echocardiographic data, and laboratory data will be collected. A     short interview will take place after enrollment during the outpatient visit or hospital     stay, or may be conducted via phone call after enrollment. All the clinical data gathered     will be compiled in Fujian provincial hospital center database, and would be stored in a     format where a culmination of clinical findings, i.e. representing a disease of interest, can     be used to search the database to identify the blood samples of all patients with such     characteristics for further study.   "
65348|NCT02430324|"     Traumatic brain injury (TBI) is a leading cause of death and disability worldwide (Ghajar,     2000). With an estimated annual incidence of up to 500 per 100,000 population and more than     200 hospital admissions per 100,000 admissions in Europe each year, TBI is a major challenge     to public health (Lingsma, 2010). Mortality and morbidity after TBI depend on several     factors, either associated with patients characteristics, the cause of TBI, the neurological     and general severity and secondary brain insults, the structural brain alterations as     diagnosed at brain computed tomography (CT) (Rosenfeld, 2012).      The prognostic value of brain CT characteristics is well documented, including the status of     basal cisterns, midline shift, the presence and type of intracranial lesions, and traumatic     subarachnoid hemorrhage (Maas, 2008). Postraumatic cerebral ischemia, which includes     functionally impaired yet still viable tissue, so-called ischemic penumbra, and irreversible     cerebral infarction (PTCI), is frequent in patients who die after moderate or severe head     trauma (Stocchetti, 2014).      Evidence of antemortem occurrence of PTCI is limited to three single-center retrospective     studies, reporting a varying prevalence of 1.9%, 8% and 19.1% (Mirvis, 1990; Marino, 2006;     Tawil, 2008). Increased intracranial pressure (ICP), blunt cerebral vascular injury, need for     craniotomy and treatment with recombinant activated factor VII, have been demonstrated to be     risk factors for PTCI. In one study, PTCI was an independent risk factor for poor outcome     after moderate or severe head trauma with a two-fold increase in mortality and severe     disability (Marino, 2006).      PTCI can be an important diagnosis in patients with significant TBI for various reasons.     First, it might influence long-term outcome. Second, as an outcome that is measurable, and     relevant to survival and lifestyle, PTCI could be used as an outcome measure in randomized     controlled trials. Third, diagnosis of PTCI could be used as a standard diagnostic reference     to validate early surrogate indicators of cerebral ischemia.      The investigators therefore planned a multi-center prospective study to investigate the     impact of PTCI on disability at hospital discharge, and on 6-month morbidity and mortality in     a population of moderate and severe adult TBI patients. The investigators also evaluated the     role of intracranial hypertension, decreased cerebral perfusion pressure, hypotension and     other secondary ischemic insults in determining the appearance of PTCI.   "
65349|NCT02430311|"     This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in     combination with paclitaxel in patients with solid tumours. Part A will assess the single and     multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of     olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of     olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2   "
65350|NCT02430298|"     The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy     induced oral mucositis and xerostomia and improving quality of life in head and neck cancer     patients. This is a randomized, double-blind, placebo controlled trial conducted in head and     neck cancer patients. Mixed-block randomization is used to divide eligible patients into two     groups: melatonin 40 mg or matched placebo. The patients are required to take the studied     drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the     first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5     fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to     standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale     and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and     adverse event frequency.   "
65351|NCT02430285|"     Acute biliary pancreatitis (ABP) is a potentially life-threatening condition caused by common     bile duct (CBD) stones or sludge, which requires prompt diagnosis and treatment by endoscopic     removal of the material. Accurate detection of CBD stones is warranted to select patients for     early therapeutic endoscopic retrograde cholangiopancreatography (ERCP).      In clinical practice the decision to perform an ERCP is often based on biochemical and     radiological criteria despite they already have been shown to be unreliable predictors of CBD     stone presence.      Endoscopic ultrasound (EUS) is not currently a worldwide standard diagnostic procedure early     in the course of acute biliary pancreatitis, but it has been shown to be accurate, safe and     cost effective in diagnosing biliary obstructions compared with magnetic resonance     cholangiopancreatography (MRCP) and ERCP and therefore in preventing unnecessary ERCP and its     related complications.      The investigators aim to investigate the clinical usefulness of early EUS in the management     of ABP.      All consecutive patients entering the emergency department due to acute abdominal pain and     showing biochemical and/or radiological findings consistent with possible ABP will be     prospectively enrolled. Patients will be classified as having a low, moderate, or high     probability of CBD stones, according to established risk stratification. All enrolled     patients will undergo EUS within 48 h of their admission. ERCP will be performed immediately     after EUS only in those cases with proven CBD stones or sludge.      The following parameters will be investigated: (1) clinical: age, sex, fever; (2)     radiological: dilated CBD, (3) biochemical: bilirubin, aspartate aminotransferase (AST),     alanine aminotransferase (ALT), gamma glutamyl transferase (gGT), alkaline phosphatase (ALP),     amylase, lipases, C-reactive protein (CRP). Association between presence of CBD stone at EUS     and the individual predictors were assessed by univariate logistic regression. Predictors     significantly associated with CBD stones (p<0.05) will enter in a multivariate logistic     regression model.   "
65352|NCT02430272|"     Anticholinergic drugs have traditionally been used for their antisialagogue properties. But     use of anticholinergic drugs can interfere with thermoregulation via inhibition of the     parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat     elimination, and children's thermoregulation depend more on sweating than adults and they can     become hyperthermic when given these agents.      The investigators evaluated the fever-causing effects of adjunctive anticholinergics in     children under general anesthesia using ketamine.   "
65353|NCT02430259|"     Tuberculosis (TB) remains the most important infectious disease in the world. Preventive     treatment plays an important role in successful control of TB. For preventive therapy, the     three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) are now     recommended by WHO for its non-inferiority, safety and convenience compared with 6~9 months     regimen of daily isoniazid monotherapy or 3~4 months daily rifampicin monotherapy. And the     treatment completion rate is higher compared with daily regimen. However, relevant study is     lacking in China where the TB burden is high with the incidence rate of 70/100, 000. And the     provision of chemoprophylaxis is not recommended in China currently.      Silicosis is a high risk factor of Mycobacterium tuberculosis infection. This is an     open-label, randomized, Phase III clinical trial to evaluate the effectiveness and     tolerability of the 3RPT/INH to prevent tuberculosis (TB) compared with those who do not     receive preventive treatment among silicotic patients.   "
65354|NCT02430246|"     Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be     tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV)     by taking vaginal smear. Treatment will be given according to the results.   "
65355|NCT02430233|"     Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational     weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day     or placebo.   "
65356|NCT02430207|"     Temporary pacing via femoral vein is used widely in mainland China, because of its     feasibility and simplicity. However, pulmonary embolism often occurred after the procedure.     It is not known that whether there was any difference in incidence of pulmonary embolism     between via different approaches. This randomized and multi-center study was designed to     verify whether temporary pacing via subclavian vein has lower incidence than via femoral     vein.   "
65360|NCT02430155|"     Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide     reaching as high as 60% in some countries.PPH can also be a cause of long-term severe     morbidity, and approximately 12% of women who survive PPH will have severe anemia.      Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth     and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has     the potential to produce hemodynamic instability should be considered a PPH. However,     clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within     the first 24 hours after delivery and approximately 70% of these cases are due to uterine     atony. Furthermore, uterine tony is defined as the failure of the uterus to contract     adequately after the child is born.      Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach     including the exclusion of retained products of conception and genital tract trauma. Uterine     atony, which is the most common cause, the management of uterine atony is an established     stepwise protocol that in many international guidelines.      Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as     excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the     recommended uterotonic drug for the treatment of PPH.      If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin,     intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including     sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade     is recommended for the treatment of primary PPH due to uterine atony in women who do not     respond to uterotonics or if uterotonics are not available.      Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus     and inflating it with water could achieve tamponade, case series and other studies have     suggested that various uterine balloon tamponade(UBT) devices may be effective in treating     PPH. The studies used various types of UBT devices, including a condom catheter, a Foley     catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine     Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success     rate of UBT does not significantly vary from surgical treatment outcomes.The World Health     Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the     American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians     and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize     balloon tamponade as a method that could significantly improve the management intractable     PPH, especially in low-resource areas.      In 2012, WHO updated the guidelines for the management of PPH and retained placenta to     include: The use of intrauterine balloon tamponade is recommended for the treatment of PPH     due to uterine atony. This recommendation is now stronger than the previous guidelines. It     can be used for women who do not respond to uterotonics or if uterotonics are not available.     This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a     higher-level facility.Furthermore, FIGO included UBT as a recommended second-line     intervention for the treatment of PPH in their updated guidelines issued in 2012.      Bakri first published the concept of intrauterine balloon technology in the management of     hemorrhage secondary to placenta praevia-accreta during caesarean section with or without     bilateral hypo gastric arterial ligation.In 2006, the ACOG Practice Bulletin, published by     the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum     balloon for its specifically tailored design that enables conservative management of uterine     bleeding in cases of uterine atony and other causes of PPH.      The idea of using a condom as a balloon tamponade was first generated and evaluated in     Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially     available UBT devices.   "
65362|NCT02430129|"     This study is a randomized controlled trial comparing total knee arthroplasty (TKA) to     unicompartmental knee arthroplasty (UKA) in patients with no to moderate anteromedial knee     osteoarthritis. TKA patients will receive the Zimmer Persona (Warsaw, IN) posterior cruciate     retaining total knee arthroplasty, while UKA patients will receive the Biomet Oxford (Warsaw,     IN) mobile bearing unicompartmental knee arthroplasty.      Outcome measures will include Western Ontario and McMaster University Osteoarthritis Index     (WOMAC) and Oxford Knee Score (OKS) questionnaires, as well as biomechanics and EMG analysis     from the investigating gait lab.      The investigators hypothesize that post-operative UKA patients will display higher clinical     scores using WOMAC and OKS questionnaires, and superior biomechanical analysis measures. The     investigators further hypothesize that the biomechanics data will assist in the understanding     of the outcome score differential both pre- and post-operatively in both groups, as well as     between-groups.      Total follow up period will be two years.   "
65363|NCT02430116|"     Background: The cardiomyocytes apoptosis induced by ischemia-reperfusion(I/R) is one of the     most important factors in the myocardial I/R injury(MIRI) undergoing cardiac valve     replacement with cardiopulmonary bypass(CVRCPB),and Ischemic postconditioning (I-postC) can     inhibit apoptosis of myocardial cells. Consequently, this study investigated the key genes     and apoptosis signaling pathways of myocardium in patients undergoing CVRCPB.      Methods: A total of 36 New York Heart Association class II or III patients with rheumatic     heart disease (RHD) of both sexes, aged 21-59 years, who were scheduled for first cardiac     valve replacement with CPB in the investigators' hospital from February 2014 to May 2015,     were randomly divided into the following three groups (n=12 each): negative control group     (NEG group); I/R group (POS group); and I-postC group (Treat group). In the Treat group, the     procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and     cross-clamping for 30 s for three cycles, after which the ascending aorta was completely     opened. The NEG and Treat groups were not treated. Thirty-six patients were assessed for     arrhythmia and recovery of myocardial contractile function after reperfusion by     electrocardiograms and degree of dependence on vasoactive drugs. The myocardial tissues of     the right atrial appendage were obtained at 3 min before CPB was established in the NEG     group, and at 45 min after opening the aorta in the POS and Treat groups. In all three     groups, the myocardial tissues of the right atrial appendage were obtained and preserved at     −80°C for further experiments. The right atrial appendage of three patients randomly selected     in each group was fixed with RNA later (Qiagen, Hilden, Germany) in a centrifuge tube     overnight at 4°C, and then preserved at −20°C for RNA extraction. Human 12×135K Gene Array     profiling of mRNA expressions was undertaken in human cardiac muscle cells. Differentially     expressed mRNAs verified by quantitative real-time RT-PCR were subjected to pathway analysis.     The mRNA expressions of AIF, APAF1, CYCS, Bax, caspase-3, caspase-9, caspase-6, caspase-7,     BCL2, BAG1, and PI3K were assessed by real-time RT-PCR and western blot analysis. The levels     of myocardial apoptosis induced by I/R were investigated by TUNEL assays. The changes in MIRI     induced by myocardial apoptosis were investigated by pathologic examination of the     myocardium.   "
65364|NCT02430103|"     The purpose of this study is to assess efficacy of gonadotropin-releasing hormone agonist     (goserelin) on the preservation of ovarian reserve function in breast cancer patients of     reproductive age treated with (neo)adjuvant chemotherapy by serial measuring the biochemical     marker AMH pre and post chemotherapy   "
65365|NCT02430090|"     45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to     march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15     µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal     administration. Hemodynamic parameters, characteristics of sensory and motor blockade,     peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the     first analgesic requirement and adverse effects were recorded.   "
65366|NCT02430077|"     Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and     predisposition to insulin resistance and its metabolic complications. Hepatic steatosis is a     common complication in patients with partial and generalized lipodystrophies.Despite     aggressive management of diabetes and hyperlipidemia, hepatic steatosis and its complications     present a therapeutic challenge in many patients. Due to this large disease burden, it is     important to assess the efficacy and safety of novel therapies for hepatic steatosis in     patients with lipodystrophies.There are, however, no systematic studies evaluating various     therapeutic interventions for reducing hepatic steatosis in patients with lipodystrophies. A     variety of drugs have been investigated in nonlipodystrophic patients with non-alcoholic     hepatic steatosis and steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD).     Recent data support the activation of the farnesoid X receptor (FXR, NR1H4), a nuclear     hormone receptor regulated by bile acids, for treatment of NASH and NAFLD. FXR activates     transcription of several genes particularly the atypical nuclear receptor small heterodimer     partner (SHP, NR0B2) and thus can influence triglyceride metabolism within hepatocytes.Both     cholic acid (CA) and chenodeoxycholic acid (CDCA) are ligands for FXR, however, UDCA which is     the 7 hydroxy β-epimer of CDCA, does not activate FXR. Obeticholic acid (OCA) is a     first-in-class selective FXR agonist which has approximately 100 fold greater FXR-agonistic     activity in the nanomolar range, as compared to CDCA .It therefore appears that FXR     modulation offers interesting therapeutic possibilities in treating hepatic steatosis. This     study is primarily designed to study efficacy of OCA, a strong FXR ligand, in reducing     hepatic triglyceride levels in patients with hepatic steatosis and Familial Partial     Lipodystrophy (FPLD). If proven to be effective, it may reduce morbidity and mortality as a     result of sequelae of hepatic steatosis in patients with lipodystrophies.   "
65367|NCT02430064|"     This study aims to investigate the effects of diets enriched or depleted in foods at high     risk of containing pro-inflammatory bacterial molecules, on markers of inflammation and     cardiometabolic risk in healthy men. The study design is an interventional diet study, with 7     days dietary advice to avoid processed foods, followed by 4 days in which lunch and evening     meal are provided to volunteers. Anthropometric and blood markers of cardiovascular disease     risk are measured at the start and end of each dietary phase. The aim is to gain an improved     understanding of how processed foods modify risk of cardiometabolic disease.   "
65368|NCT02430051|"     The goal of this project is to examine the efficacy of a sensory adapted dental environment     (SADE) for children who have difficulty tolerating oral care in the dental clinic. The     investigators hypothesize that adapting the sensory environment in the dental office by     modifying the sounds, sights,and tactile experiences will result in decreased anxiety,     increased cooperation, and fewer behavior problems for children with Autism Spectrum     Disorders (ASD). This has the potential to contribute to increased child comfort as well as     safer, more efficient, and less costly treatment for a large population, as potentially more     than one-fourth of all children may benefit from a sensory adapted dental environment.   "
65369|NCT02430038|"     This is a prospective observational study of transperineal ultrasound between 24-42 weeks     gestation and a prospective longitudinal observational study in all term (37-42 weeks)     labouring women.   "
65387|NCT02429804|"     This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/     fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging     (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating     patients with prostate cancer that has not responded to hormone therapy and has spread to     other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors     accurately measure how well patients respond to treatment with radium Ra 223 dichloride.   "
66322|NCT02417584|"     The aim of the study was to determine the long term effects of compliance with positive     airway pressure therapy on blood pressure in both hypertensive and normotensive patients with     obstructive sleep apnoea hypopnoea syndrome.   "
65371|NCT02430012|"     The investigators have identified underuse of secondary prevention medications at discharge     of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study     is to develop series of quality improvement strategies focusing on secondary prevention     medications for patients underwent CABG, and to evaluate their effectiveness and safety via a     hospital-level cluster randomized clinical trial. The investigators established a network of     60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and     submitted 50 or more CABG surgeries already. The participating sites will be divided into     intervention and control groups in a 1:1 ratio. The intervention group will undertake     intervention of quality improvement strategies, while the control group will maintain the     routine practice pattern. All hospitals will consecutively enroll and submit data of CABG     during the enrollment period, estimated for 6 months. The prescribing rates of angiotensin     converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), beta-blockers,     statins and aspirins will be compared between 2 groups.   "
65372|NCT02429999|"     Infertility in not a health problem and that infertile couples are not really ill. However,     this narrow interpretation of the problem is refuted by the world community. The WHO defines     health as a state of complete physical, mental and social wellbeing and not merely the     absence of disease or infirmity. It has also been argued that overpopulation is the main     problem in the developing countries and that helping infertile couples contradicts the     interests of the countries and the world at large. However, this narrow approach contradicts     human rights in general and reproductive rights in particular.      In 1994, the United Nations International Conference on Population and Development in Cairo     mentioned issues on future actions on 'prevention and appropriate treatment of infertility     where feasible'. However, no guidelines or concrete actions and programmes were given for     developing countries.      Worldwide, more than 80 million couples suffer from infertility; the majority of this     population are residents of developing countries.      In September 2001, a meeting on 'Medical, Ethical and Social Aspects of Assisted     Reproduction' was organized by the WHO. For the first time, major attention was paid to     ongoing developments in assisted reproduction technology together with their social and     ethical implications in developing countries . It was the first time that the WHO highlighted     the issue of assisted reproduction in developing countries.      ART in developed countries is highly expensive one of steps is ovulation induction the most     common protocol for induction is the long gonadotrophin-releasing hormone (GnRH) agonist     pituitary suppression regimen combined with relatively high doses of exogenous     follicle-stimulating hormone (FSH) remains the most frequently used stimulation protocol     which is expensive. in our study we will use a mild ovarian stimulating protocol letrozole     adjuvant to gonadotrophins which is less expensive      The use of aromatase inhibitor have only recently been introduced in infertility treatment,     especially for ovulation induction.      An aromatase inhibitor blocks the conversion of androgens to estrogens in the ovarian     follicles, peripheral tissues, and in the brain. This result in two things: (a) Fall in     circulating and local estrogens and (b) Rise in intraovarian androgens. Fall in estrogen     levels, releases the hypothalamopituitary axis from the negative feedback of estrogens. Thus,     there is a surge in follicle stimulating hormone (FSH) release, which results in follicular     growth. Since, the feedback mechanism is intact; normal follicular growth, selection of     dominant follicle, and atresia of smaller growing follicle occurs; and thereby facilitating     monofollicular growth and ovulation.Another mechanism of action of the aromatase inhibitors     is by the increasing intraovarian androgens. This increases the follicular sensitivity to     FSH. Recent data shows the role of androgens in early follicular developments. by augmenting     FSH receptors and stimulating insulin-like growth factor (IGF)-I; FSH and IGF-I act     synergistically to promote follicular growth. This pharmacodynamics of letrozole ensures     improved endometrial thickness, cervical mucus, monofollicular, and better folliculogenesis.     So , these factors may lead to higher pregnancy rates and greater likelihood of singleton     pregnancy.      Letrozole has been tried for ovarian stimulation for assisted reproduction. With the concept     of mild stimulation in IVF to improve implantation rate, letrozole is a potential agent.     Letrozole has two potential uses in IVF: First, where it is used in the follicular phase     usually with FSH/human menopausal gonadotropin (HMG) for ovulation induction; second, it has     also been used in luteal phase of stimulated IVF cycle and to reduce circulating E2 levels;     thus, potentially reducing ovarian hyperstimulation syndrome (OHSS) risk.      A significant reduction in the total dose of gonadotrophins was found when aromatase     inhibitor was added in controlled ovarian hyperstimulation (COH) cycles.      Some studies evaluated the addition of letrozole in patients with normal ovarian response     undergoing IVF or Intracytoplasmic sperm injection( ICSI). They showed higher implantation     and ongoing pregnancy rates in the letrozole cotreatment group.   "
65373|NCT02429986|"     Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be     reimbursed according to the French Social Security rules, the patient treated with an ASV     needs to be examined each year. In this observational transversal single-visit study, the     investigators aim to describe the clinical characteristics of patients treated with ASV and     the associated device settings.   "
65374|NCT02429973|"     Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of     metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin     in metastatic or unresectable osteosarcoma patients.   "
65375|NCT02429960|"     Until today there is no standard-monitoring to specifically reflect the analgesic component     of general anesthesia. Quality and safety of general anesthesia are of major clinical     importance and can be improved by limiting the administration of opioid analgesics to the     minimum dose needed. This study therefore examines the quality of three different monitoring     techniques (PhysioDoloris, MetroDoloris, Lille, France, SPI (Surgical Plethysmographic     Index), GE Healthcare, Helsinki, Finland and AlgiScan, IDMed, Marseille, France) in assessing     the level of analgesia during general anesthesia. Therefore a standardized painful stimulus     is applied under different levels of analgesic drugs. The monitor's indices are compared to     clinical signs such as an increase in heart rate and blood pressure.   "
65376|NCT02429947|"     The purpose of this study is to identify the issues that have greatest impact on QOL for     patients with Charcot Marie Tooth (CMT) Disease. Patients who have -registered in the     Inherited Neuropathies Consortium Contact Registry will be invited to participate.   "
65377|NCT02429934|"     This research trial is for patients who have been diagnosed with systemic lupus erythematosus     (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the     SLE.      The purpose of this clinical research study is to evaluate the safety and effectiveness of     treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly     for 16 weeks versus placebo injections(a substance with no active ingredients and therefore     may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The     effectiveness will be assessed primarily by the number of swollen, tender joints (called a     joint count) at each of study visits.      Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by     prescription and has not been approved by the U.S. Food and Drug Administration for treating     SLE yet.      In this study, subjects will receive treatment with either abatacept or placebo once a week     for 16 weeks (a total of 16 injections).   "
65378|NCT02429921|"     About 45 million people in Bangladesh are chronically exposed to unacceptable levels of     arsenic in their drinking water. Chronic arsenic poisoning leads to cancers, and vascular     diseases.      This dietary trial intends to test the potential of high-selenium lentils, consumed as lentil     soup, in reducing the arsenic body burden in an exposed Bangladeshi population, and in     improving the overall health status.      Arsenic-exposed families will be assigned to one of two groups. One group will eat lentils     (50g/person/day) that are naturally high in selenium, the other group will receive lentils     with low selenium content. This 6 months trial is randomized and double-blinded.   "
65379|NCT02429908|"     This study is a post-market clinical follow-up study to fulfill the post-market surveillance     obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The     data collected from this study will serve the purpose of confirming safety and performance of     the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in     reducing patient disability.   "
65380|NCT02429895|"     A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic     Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled     Trial (RCT).   "
65381|NCT02429882|"     The purpose of this study is to assess the safety and efficacy of brodalumab compared with     placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1     ratio to brodalumab or placebo for the first part of the study. Subjects will then receive     open label brodalumab for the remainder of the study. The entire study will be 312 weeks in     duration for each subject.   "
65382|NCT02429869|"     Zortress (everolimus), the 40-O-(2-hydroxyethyl)-derivative of rapamycin, is an mTOR     inhibitor approved for rejection prophylaxis in kidney transplant recipients. mTOR inhibition     may favorably impact the HIV viral reservoir, and we hypothesize that adding everolimus to     the transplant immunosuppressive regimen of HIV positive transplant recipients will decrease     HIV persistence in CD4+ lymphocytes.   "
65399|NCT02429648|"     The purpose of this study is to compare which strategy is superior in patients with     persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current     cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein     isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the     patient remains in atrial fibrillation.   "
65409|NCT02429518|"     This study is a Phase 4, open-label, single group study in which at least 40 adult patients     undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed     by 12-lead ECG for prolongation of the corrected QT interval   "
67813|NCT02398110|"     Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet     comparative studies are lacking. The aim of this study was to compare the surgical outcomes     of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.   "
65388|NCT02429791|"     The aim of this study is to determine if virologically suppressed human immunodeficiency     virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside     reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching     to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily     assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared     to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for     eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include     2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase     inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label     treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch     Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will     participate in the Early Switch Phase where they will either switch from their CAR to DTG +     RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible     participants will proceed to the Late Switch Phase where all participants in both DTG + RPV     and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148,     subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study     is planned to be conducted in approximately 476 participants.   "
65389|NCT02429778|"     The PI developed a self-directed program to treat late-life anxiety called Breathing,     Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This     program consists of weekly video lessons that participants watch on digital video disc (DVD)     along with weekly telephone check-ins. In BREATHE participants will learn two behavioral     interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose     of the study is to examine whether the self-directed BREATHE program is superior to a wait     list control in reducing anxiety in older adults with anxiety disorders. For those assigned     to wait list control, they will be offered opportunity to participate in BREATHE treatment     after 8 weeks of wait list.   "
65390|NCT02429765|"     A number of studies have documented poor sleep quality and troublesome symptoms     (breathlessness, cough and sputum production) upon awakening in patients with COPD. However,     the investigators know very little about measurements of respiratory mechanics (i.e., lung     volumes, respiratory pressures, diaphragm function, etc) during sleep in these patients. The     investigators also know little about how modern bronchodilator therapies, or the timing of     when they are taken, affect respiratory mechanics during sleep or the severity of early     morning respiratory symptoms. COPD is often treated with inhaled bronchodilator medications     which are used to open up airways and make it easier for air to get in and out of the lungs.     The investigators are studying the effects of a new inhaler that contains two different types     of long-acting bronchodilator: formoterol [a long-acting beta2-agonist (LABA)] and aclidinium     bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]. Initial studies have     shown that this combination therapy taken twice daily can improve some lung function     measurements and respiratory symptoms in patients with moderate to severe COPD. There are     also reports that evening administration of this medication may provide important advantages     in patients with dominant nighttime and early morning symptoms. It is thought that sustained     bronchodilation and lung deflation during the night may improve respiratory mechanics,     diaphragmatic function, pulmonary gas exchange, sleep quality, and reduce severity of morning     symptoms. This study will be the first to explore the effects of a nighttime dose of     aclidinium/formoterol combination therapy on detailed measurements of respiratory mechanics     and early morning symptoms in COPD. This study will also give us a better understanding of     the mechanisms of early morning respiratory symptoms and their improvement with     bronchodilators.   "
65391|NCT02429752|"     The goal of this study is to identify if there is a significant prevalence of abnormal     respiratory patterns in a sample of patients with low back pain (LBP), and if the presence of     abnormal respiratory patterns are predictive of rehabilitation outcomes in this population.     In addition, the investigators will assess the response to inspiratory muscle training (IMT)     for a subgroup of subjects that maintain abnormal breathing patterns after 1 month of     physical therapy. Patients seeking physical therapy for LBP within the Uhealth system will be     recruited. The first phase of this study will be observational. A comprehensive assessment of     their respiratory function will be performed at the beginning of their therapy and after 1     month of therapy. Subjects that demonstrate abnormal respiratory patterns after 1 month of     therapy will be offered the opportunity to participate in the second phase of the study in     which they will receive 1 month of inspiratory muscle training (IMT). The respiratory     assessment will then be repeated at the end of the IMT training program.   "
65392|NCT02429739|"     The main aim of this interventional study is to investigate whether the effects of     computerized working memory training improves reading abilities for children, i.e. ages 9 -     16 years, diagnosed with dyslexia.   "
65393|NCT02429726|"     Objective of this study is to investigate of efficacy and safety of recombinant adenoviral     human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin.     This is a phase 2, double blinded, randomized, active controlled study.   "
65394|NCT02429713|"     Tourniquets are still widely used in total knee arthroplasty, but are associated with several     adverse effects. Most of previous studies did not randomize the participants so the baseline     difference of the patients might have influenced the outcome. Therefore, investigators     conducted a randomized controlled trial, in which all the patients received staged bilateral     TKA with two different durations of tourniquet use. Investigators aimed to quantify the     effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use     on functional and clinical outcome.   "
65395|NCT02429700|"     Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has     the same curative effects and less adverse effects than bleomycin, etoposide and     cisplatin(BEP) among newly diagnosed ovarian malignant sex cord-stromal tumor patients after     surgery.   "
65396|NCT02429687|"     Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has     the same curative effects and less adverse effects than bleomycin, etoposide and     cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after     surgery.   "
65397|NCT02429674|"     The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents     (IPT-A) with depression works to change sleep and related biological markers found in saliva,     namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this project is     to understand the biological mechanisms of recovery from depression in order to assist in     selecting and guiding personalized psychotherapeutic interventions with the highest     likelihood of success for individual adolescents with depression.   "
65398|NCT02429661|"     The purpose of this study is to determine the social, emotional, physical, and educational     effects of Girls First, a combined resilience and adolescent health program, vs. its     components and a control group, among adolescents in India.   "
65446|NCT02429024|"     Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients     with Type I and Type II diabetes.   "
65400|NCT02429635|"     The aim of this research study is to assess the effectiveness of an intervention on exercise     and health, and to contribute to the understanding of how team-based worksite health     promotion programs should be designed in order to increase and maintain exercise among     employees. The study design is a randomized controlled trial.      There are a number of different theories on the subject of how to affect motivation for     health behavior change. This study is based on the tenets of Self-Determination Theory (SDT)     in combination with elements from Motivational Interviewing and in accordance with the Health     Promotion Guidelines developed by the National Institute of Health and Clinical Excellence,     NICE.      It is assumed that if such a program is designed and offered in a manner that satisfies the     participants' sense of autonomy, competence and relatedness, this will affect the quality of     the participants' self-regulated motivation and perceived competence for exercise and     lifestyle changes. As a consequence, a large proportion of the participants will adhere to     the program and increase their exercise both in the short (5 months) and long term (8     months).      The following research questions will be:        1. Would a team-based health and exercise promotion intervention designed to be needs          supportive, relative to a control group:             1. Influence increases in exercise levels, improved aerobic fitness, reduced blood               pressure, and decreases in waist circumference, and Body mass index (BMI), in               addition to changes in body composition in terms of reduced percentage of fat and               increased percentage of muscles?             2. Influence increases in psychological well-being?             3. Influence increases in perceived investment in employees' health competence, which               would positively predict affective organizational commitment and job performance,               and negatively predict turnover intentions?             4. Influence decreases in sickness absenteeism?        2. If so, would changes in psychological needs support, autonomous motivation for exercise,          perceived competence and self-efficacy in exercise mediate these effects?   "
65401|NCT02429622|"     This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT     simultaneous integrated boost technique with or without concurrent chemotherapy for locally     advanced esophageal carcinoma.   "
65402|NCT02429609|"     The measurement of visual acuity is made using black letters of varying size superimposed on     a uniform white background. The objective is to determine the smallest letter, or optotype,     that can be correctly identified. One limitation of current tests is the variability of     measurements, this making it difficult for clinicians to determine if changes in visual     acuity are related to ocular disease. This variability has been attributed to the design of     current optotypes, in particular their differing legibilities. Our group has recently     demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters     with a black core and a white border presented on a grey background, reduces the variability     of visual acuity measurements. In this study the investigators wish to determine if changes     in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape,     may be detected more easily using the Moorfields Acuity Chart compared with conventional     letter charts.   "
65403|NCT02429596|"     Background. Anecdotal reports and uncontrolled studies have described an association between     generic substitution of antiepileptic drugs (AEDs) and adverse events, including loss of     seizure control. Although these results are likely to be influenced by methodological bias,     they have led to a strong opposition, among physicians and patients, to the use of generic     products in epilepsy.      Objectives. The primary objective is to assess potential risks associated with substitution     of the currently taken AED product with an equivalent product, using as endpoint changes in     serum drug levels at steady-state after substitution compared with baseline. Secondary     objectives will be the assessment of inter-subject variability in serum drug concentration on     an unchanged treatment schedule, and evaluation of potential short-term changes in seizure     control and adverse events rate.      Methods. The study will use an experimental randomized open-label non-inferiority design. The     population will consist of 200 adults stabilized on chronic treatment with carbamazepine,     valproic acid, topiramate, oxcarbazepine, levetiracetam or lamotrigine and admitted to     hospital for diagnostic evaluation or other indications, with no expected treatment changes     during the subsequent 5 to 6 days. Patients will be randomized to two groups. One group will     continue to receive the AED products used before enrollment (brand or generic), whereas the     other group will be switched to an alternative equivalent product. Dosing schedules of the     AEDs being tested as well as comedications will be unaltered throughout the 6- to 7day period     of the study. Serum AED levels (mean of two values obtained at peak and trough, respectively     in the evening and the next morning) will be measured on day 1 (baseline) and 5 days     post-randomization (6 days for patients receiving AEDs with half-lives above 12 h). The     primary outcome endpoint will be the proportion of patients who, post-randomization, show a     greater than 25% change in serum drug concentration compared with baseline. Secondary     endpoints will include comparison of distributions of rough serum concentration changes     between groups, other pharmacokinetic parameters, time to first seizure, total number of     seizures, and adverse events.   "
65404|NCT02429583|"     This study will investigate the effects of chronic HCV infection and corresponding innate     immune activation on the immune response to HBV vaccination. We will recruit chronic HCV     patients and healthy control patients for HBV vaccination. We will use RNA Sequencing     (RNA-Seq), a relatively new technology for simultaneously measuring the expression of all     genes, to determine patients' innate immune status, and learn how this innate immune     signature is related to HBV vaccine response. We will then explore the mechanisms by which     chronic HCV infection affects different immune cells and functions that are known to be     important for an effective HBV vaccine response. These studies will enhance our understanding     of the immune effects of chronic viral infection, establish factors that determine effective     vaccine responses, and help guide vaccination strategies for HCV patients and other     individuals with chronic inflammatory disease.   "
65405|NCT02429570|"     Cancer that has spread to the brain, or brain metastasis, is difficult to treat.     Meclofenamate is a drug which has been shown to reduce brain metastasis growth in the     laboratory. This medicine has been used in the past to treat pain. But, in this study, it     will be used to prevent new brain metastasis. This is the first time that meclofenamate will     be used in patients with brain metastasis.      This is a pilot study which means that the purpose of this study is to determine if a larger     clinical trial of meclofenamate is possible in patients with brain metastasis. This study     also aims to find out what effects, good and/or bad meclofenamate has on the patient and the     cancer that has spread to the brain. The investigators also want to learn more about     potential effects that this drug may have in the digestive system.   "
65406|NCT02429557|"     Compression garments have been shown to be effective in the treatment of orthostatic     hypotension in autonomic failure patients. The purpose of this study is to determine the     hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing     blood pressure and orthostatic tolerance in these patients, and to compare them with those of     the standard of care midodrine. The investigators will test the hypothesis that abdominal     compression will blunt the exaggerated fall in stroke volume and the increase in abdominal     vascular volume during head up tilt.   "
65407|NCT02429544|"     The goal of this behavioral research study is to compare 2 different types of residential     group programs to help researchers learn if and how well these groups may help to improve     physical and emotional well-being in patients with stage IV breast cancer.   "
65410|NCT02429505|"     This study is a prospective observational study in which patients undergoing treatment for     leishmaniasis with miltefosine (Impavido) in the US and who weigh > 75 kg can volunteer to     provide information about their clinical response to treatment up to 6 months after the start     of treatment.   "
65411|NCT02429492|"     Amyotrophic lateral sclerosis (ALS) is due to neurodegeneration of upper and lower motor     neurons, leading to muscle atrophy, paralysis and death. However, there is growing evidence     that interneurons involved in the gain regulation of spinal motoneuron (lower motor neurons)     and in sensorimotor integration may participate in the pathogenesis of ALS. While sensory     afferents in the peripheral nerve are traditionally thought to be unaffected at the beginning     of the disease, diffusion MRI has revealed degeneration and demyelination of the posterior     columns in the spinal cord of patients recently diagnosed with ALS, and there are sporadic     reports of sensory involvement. Early alteration of the sensorimotor integration could     participate to the degeneration of motor neurons and interneurons. The goal of the project is     to further investigate sensorimotor integration at spinal level in human patients recently     diagnosed with ALS, and to study whether an interneuron pathology could participate in ALS     pathogenesis.      Our project has first an interest for the fundamental research aiming at increasing basic     knowledge of pathophysiology of ALS, and specifically on the functional effects of the     underlying neurodegenerative mechanisms. By testing the excitability of spinal interneurons     in patients recently diagnosed, and by doing so for clinically uninvolved muscles, we will be     able to evaluate whether an interneuron pathology could be involved in ALS. Our results will     help to understand better the chain reactions in the neurodegenerative processes that     dramatically evolve until the death of all motor neurons. Our project has also an interest     for the development of therapeutic approaches for ALS. Indeed, our methods will help to     determine specific electrophysiological biomarkers that will help to evaluate quantitatively     spinal and corticospinal neural processes: their changes during the course of the disease     (follow-up study), the effect of therapeutic agents and/or rehabilitation methods on their     excitability, and their repercussions on motor neuron activity (evaluation of therapeutics).     Lastly, our methods could be tested in other neuromuscular diseases to determine possible     differences in spinal neural activity. Indeed, the motor dysfunction common to several     neuromuscular diseases can make it difficult to make a definitive diagnosis. The development     of specific biomarkers is crucial for an early diagnosis, and to evaluate the best treatment     for the patients as rapidly as possible.   "
65412|NCT02429479|"     The overarching goal of the project is to improve the process and experience of surrogate     decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is     a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy     --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a     surrogate decision-maker.   "
65414|NCT02429453|"     The goal of this study will be to determine whether PCC confers any benefits over FFP in     traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including     time to correction, absolute international normalized ratio correction amount, cost, need for     surgical intervention, and radiographic bleed expansion through a prospective, randomized     control trial.   "
65415|NCT02429440|"     Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic     adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage     colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer     (RCC).   "
65416|NCT02429427|"     It has been found that the chemical changes that take place in a patient's body during the     development of inflammation may provide an environment which stimulates cancer cells. One     step in the development of inflammation is the production of certain chemical substances     which are important in the formation and spread of tumours. These are called prostaglandins.     Cyclo-oxygenase II (COX-2) is an enzyme (a substance that speeds up chemical changes in the     body) involved in the production of these prostaglandins and although it is not usually     present in most tissues it is made at the sites of inflammation. Celecoxib is a selective     Non-Steroidal Anti Inflammatory Drug (NSAID) which works by blocking the action of the COX-2     enzyme, leading to a decrease in the production of prostaglandins and a reduction in     inflammation.      The purpose of this study is therefore to find out if celecoxib can be used after breast     cancer treatment (chemotherapy and/ or radiotherapy) to reduce inflammation and thus reduce     the ability of new tumours to grow and survive.      2590 women with primary breast cancer will be recruited in this study from several locations     in the United Kingdom and Germany. Eligible patients will be randomly allocated a treatment     group, which can be celecoxib or placebo. Both treatments are taken orally (celecoxib 400mg     daily, placebo 2 tablets daily) for a total of 2 years. In addition, hormone receptor     positive patients will receive endocrine treatment as per local practice. Patients will     prematurely discontinue treatment with celecoxib/placebo if disease progression is confirmed     or if patients experience unacceptable toxicity.      Patients will be seen every 6 months for the first 3 years and then off treatment follow-up     is carried out annually. Participating patients will also be given the option to take part in     the pathology sub-study by donating a sample of the tumour tissue collected at the time of     the primary surgery.   "
65417|NCT02429414|"     The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy (FOB     -- also known as a fiberoptic scope procedure) needs to be used with a video double lumen     tube (VDLT) during surgeries that require lung isolation. On this study, you will have one of     2 types of commonly-used breathing tubes used, either a VDLT or a non-video double lumen tube     (called a non-video DLT). An FOB may or may not be performed, as described below.      The level of effectiveness of the VDLT and non-video DLT will be compared.   "
65418|NCT02429401|"     In this comparative-effectiveness study, investigators will recruit 400 English-speaking,     Spanish-speaking, or bilingual heavy-drinking Mexican-origin men admitted to a community     hospital for medical treatment of an alcohol-related injury or heavy drinking. Participants     will be randomized to receive a culturally adapted brief motivational intervention (CA-BMI)     or a non-adapted brief motivational intervention (NA-BMI). The primary outcomes of interest     include alcohol use, alcohol problems, and treatment utilization. Secondary outcomes include     therapeutic alliance ratings and social support. Telephone follow-up assessments will be     completed at 3, 6, and 12 months post-treatment.   "
65822|NCT02424136|"     Peanut allergy can be life-threatening. Current diagnostic techniques for peanut allergy have     high sensitivity, but not high specificity. This clinical trial will test the validity of a     novel blood biomarker (compared with current testing) as a diagnostic predictor of     anaphylaxis to peanut.   "
65419|NCT02429388|"     Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to     usual heart failure care versus usual care in patients with acute decompensated heart     failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose     spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF     until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal     bloating and/or jugular venous distention. Assessment of clinical status and serum     electrolytes, symptoms and renal function will be performed in accordance to standard of     care.   "
65420|NCT02429375|"     The purpose of this study is to find out how safe and effective treatment with a new     combination of drugs, mocetinostat and brentuximab vedotin, is in treating cancer. There will     be 2 parts to this trial: a phase I part and a phase II part.      Brentuximab vedotin is approved by the U.S. Food and Drug Administration (FDA) to be given to     patients with Hodgkin Lymphoma. Mocetinostat is an experimental drug that has been given to     patients with Hodgkin lymphoma in another clinical trial. When given alone, mocetinostat     caused lymphoma to shrink in about 1 out of 4 patients with Hodgkin lymphoma. This is the     first study that will give mocetinostat and brentuximab vedotin together.   "
65465|NCT02428777|"     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in     reducing pain during operative outpatient hysteroscopy. Women undergoing operative     hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1     hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue     scale   "
65421|NCT02429362|"     Subjects are being asked to donate blood, urine, vaginal secretions and/or tissue to a     repository for research.This repository will store donated specimens for future research. The     Department of Obstetrics and Gynecology at the University of Tennessee Health Science Center,     under the direction of Dr. Giancarlo Mari, Professor and Chair, is responsible for the     operation of the repository.      Additionally, in the case of a stillborn child, the mother will be given the opportunity to     donate samples from her stillborn baby's autopsy to a repository for research.   "
65422|NCT02429349|"     The purpose of this study is to assess the results of ovarian tissue freezing, such as     resumption or initiation of menses (menstruation: the discharge of blood and tissue from the     uterus that happens about every 4 weeks in females who are not pregnant) and pregnancy, prior     to starting chemotherapy or radiation treatment (commonly used for cancer treatment or for     other conditions such as multiple sclerosis, psoriasis, rheumatoid arthritis). Females who     are about to undergo chemotherapy or radiation therapy for cancer or these other medical     conditions may stop having menses and may not be able to produce a biological child. Girls     who have not achieved puberty and are exposed to chemotherapy (alkylating agents) or     radiation treatment, the risk is up to 22-50%. In contrast, girls older than 10 years, or who     have achieved puberty, experience acute ovarian failure in over 50% of the cases. By freezing     and preserving ovarian tissue will help prevent these outcomes. In fact, when you are     considered cured of your disease, you will have another surgical procedure where your own     ovarian tissue will be transplanted back to you. This surgery will increase the possibility     of resuming/initiating menses and the chance to have a pregnancy.   "
65423|NCT02429336|"     The purpose of this study is to collect data that will be generated during an office visit.     The data will be gathered and analyzed in research studies that will help with the     investigators understanding of various medical conditions.      About 200 subjects will be participating in this study. Participation in this study will not     require a patient's time or presence. The medical information contained in a patient's chart     from the office visit, including the results of any tests that were ordered at that time,     will be transferred to an anonymous database and analyzed together with data from other     patients who have similar condition/s.      No follow-up information will be collected. The following information will be collected from     a patient's medical record: the medical history and a list of the current medications.   "
65424|NCT02429323|"     Aim of the study is to compare the optimal time needed for successful tracheal intubation     with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric     patients undergoing adenotonsillectomy without using muscle relaxants or opioids   "
65425|NCT02429310|"     This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device     to standard treatment of supervised exercise in patients suffering from symptoms and effects     of lower limb Intermittent Claudication.   "
65426|NCT02429297|"     The purpose of the study is to evaluate the feasibility and impact of an automated phone     system in monitoring and improving self-care and health outcomes among patients with diabetes     and/or hypertension in Bolivia, in addition to assessing the additional benefit of support     from a family member or friend.   "
65427|NCT02429284|"     The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical     course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension     (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry     will be to promote a greater understanding of the prevalence, pathophysiology, evaluation,     and treatment of patients with CTEPH through shared information, education, and collaborative     investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.   "
65428|NCT02429271|"     This is a prospective randomized study, which investigates the coronary microvascular     function as assessed by coronary angiography after administration of ticagrelor compared with     clopidogrel in patients with myocardial infarction and ST segment elevation after     thrombolysis.   "
65429|NCT02429258|"     Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately     Controlled With Either Metformin Or Insulin   "
65430|NCT02429245|"     The knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this     intervention usually provides a significant improvement in the quality of life of patients.     However, a significant percentage of patients (up to 30%) are disappointed with the outcome     of the intervention. One hypothesis that could explain these poor results might be the poor     positioning of implants. Individual cutting guides are produced after a CT scan response     planning carried out according to the CT scan anatomy of each patient, and subsequently     adapted to its real anatomy during surgery, thus theoretically better accuracy of the     implementation over conventional techniques. It has been shown in the past that the     navigation has been the gold standard in measuring the three-dimensional orientation of the     implants during surgery, and this system is systematically used in the service for over 10     years.   "
65877|NCT02423408|"     This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to     evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a     single qualifying Tension-Type-Headache (TTH).   "
65431|NCT02429232|"     Diabetes mellitus is a common disease with much impact on human's health and is related to     osteoporosis. But the mechanism remains unclear. The foreign researches revealed     thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially     elderly women. However, it is still controversial in terms of the youth and men. In     Taiwan,there is few related study to analyze the relationship between TZD and steoporosis.      This is a multicenter randomized controlled study.   "
65432|NCT02429219|"     Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an     ethanol-containing saline irrigating fluid, prospective detected by breath alcohol     measurement.   "
65466|NCT02428764|"     The purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin     followed by surgery to see how well it works in treating patients with unresectable stage III     squamous cell lung carcinoma.   "
65525|NCT02427997|"     A prospective, randomized controlled single-blind trial will test the hypotheses that a 6-     week intervention that combines treadmill training (TT) with virtual reality (VR)     significantly improves real-life, functional mobility and cognitive abilities, keys to     health-related quality of life in patients with MS.   "
65526|NCT02427984|"     During last 6 years approximately 10.000 ceramic balls and 5.000 ceramic liners have been     implanted in the region Emilia-Romagna in Italy (4 million Every single year approximately     60.000 hip prostheses are implanted in Italy. Quality of life of patients after surgery is     very good, as widely demonstrated in the literature. On the basis of data produced by the     only complete hip register in Italy that is run in our Lab (RIPO, Register of Orthopedic     Implants in the Region Emilia-Romagna) survival rate of primary total hip prosthesis is 95.6%     at 9 years. Reasons for revision are mainly aseptic loosening of one or both components (40%     of the total) and dislocation (26%), being the latter much more frequent in the first two     years. Less frequently revision is due to sepsis (7% of the total),bone fracture (11%),     prosthesis fracture (3%) or pain (3%). Revision is relates, among the others, to     prosthesis-related factors, such as fixation to bone and articular coupling. In our     experience, during the last ten years 32% of implants had both articular component in ceramic     , 34% had metal head and plastic liner, 24% ceramic head and plastic liner, 10% both     components in metal.      Each solution has strengths and weakness and they have been identified and clinically applied     in order to overcome step by step limitations observed in the previous one. The most recent     are the hard-on-hard bearings, that is ceramic on ceramic and metal on metal. These two     solutions, beside very promising results on wear resistance, show some peculiar failures:     respectively fracture of the ceramic component and hypersensitivity induced by metal ions.      Aim of research proposal is to investigate two uncommon and less investigated early symptoms     of failure:        -  'noising hip' in ceramic on ceramic total hip arthroplasty        -  pain without radiographic signs of loosening in metal on metal total hip arthroplasty          These two situations are extremely relevant, as they prelude to a failure of the          prosthesis. If clearly identified they could represent a powerful tool in early          diagnosis of pending failure To reach this goal our patients wearing hard-on-hard total          hip arthroplasty, suffering for described symptoms will undergone a specific diagnostic          procedure.      The first group will be studied through CT scan of the patients to evaluate impingement or     instability of the prosthesis, and a needle aspiration for synovial fluid. The fluid will be     examined to identify ceramic wear debris, according to a method of separation and analysis in     scanning electron microscopy that was set in our Lab.      Sound will be recorded by means of a wearable sensor set capable of recording the articular     noise produced during level walking. This instrumentation will be coupled to motion analysis     technology.      This would make possible a diagnostic approach able to correlate the involved factors to     clinical occurrences, on the basis of the recorded frequencies.      -Second group will be studied through the dosage of circulating ions, deriving from the     articular surfaces and through the histological classification of vasculitis in periimplant     tissues. There is increasing evidence, indeed that locale release of submicron particles worn     out from articular surfaces can release metal ions (mainly Chromium and Cobalt) responsible     for lymphocyte local infiltration. In particular CD20 positive B lymphocyte and CD3 positive     T lymphocyte and sometimes CD68 positive plasma cells are present. The cells could justify     the development of pseudotumors in metal-on metal hip prosthesis.      Data collected from patients matched to in vitro results will allow us to to avoid or at     least propose a more appropriate timing for revision surgery.   "
65433|NCT02429206|"     In the general population, xerosis is often caused by external factors such as seasonal     changes. In that case, the best way to relieve dry skin is to use a standard moisturizer.     However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord     injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of     the multiple causes (endogenous rather than exogenous ones) underlying such mobility     impairment-related skin problems. This study is a double-blind, randomized study with     positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs     (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in     patients suffering of paralysis.   "
65434|NCT02429193|"     This is an open-label phase 2 multi-center study of abiraterone and enzalutamide in men with     castration-resistant prostate cancer. Sixteen patients will be enrolled over 18 months.   "
65435|NCT02429180|"     A pilot study that will evaluate the feasibility and acceptability of procedures to inform     the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and     cost effectiveness of ReTrain for stroke survivors).   "
65436|NCT02429154|"     The purpose of this study is to show that a permissive hypercapnia during mechanical     ventilation in children under general anaesthesia will improve cerebral perfusion.   "
65437|NCT02429141|"     In the transarterial technique for axillary brachial plexus block, the axillary artery is     intentionally punctured to indicate placement of the needle within the neurovascular sheath;     local anesthetic is then injected deep and superficial to the axillary artery.   "
65438|NCT02429128|"     The aim of this project is to investigate the pathophysiology of PCOS in regards to the     metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose     tissue, and to investigate the effects of exercise training on these parameters.   "
65439|NCT02429115|"     Receiving supportive mentoring from well-adjusted individuals who share similar experiences     has had a positive influence on adjustment with some chronic diseases. In this study,     patients with advanced chronic kidney disease and caregivers of such patients will be     randomly assigned to one of three groups: (1) face-to-face PFPP—individuals will receive six     months of PFPP peer-mentoring, along with an informational text; (2) online PFPP—individuals     will receive six months of online peer-mentoring modeled after the PFPP program, along with     an informational text; and (3) information-only control group—individuals will receive the     text of the material provided to the other two groups. The study team's decision to include     an online version is based on suggestions by previous participants who indicated that this     would be convenient for individuals for whom distance and geographic location are major     considerations of participation.      The investigators expect that both face-to-face and online peer-mentorship programs will     result in improved quality of life among patients with advanced kidney disease and decreased     feeling of burden among caregivers of these patients. The investigators also expect that     mentorship will lead to improved engagement of patients in their own care.   "
65440|NCT02429102|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     MT-8554 in healthy Caucasian subjects.   "
65441|NCT02429089|"     In this trial, the investigators would like to investigate the activity of LEE011 associated     with cetuximab (standard of care for the SCCHN patients at this stade of the disease).   "
65442|NCT02429076|"     The aim of this study is to test the hypothesis that methylphenidate actively induces     emergence from propofol and sevoflurane general anesthesia in healthy volunteers.   "
65443|NCT02429063|"     Fatigue is one of the most consistent and distressing symptoms reported by pediatric oncology     patients. The investigators' work has demonstrated that in the period from diagnosis through     the initial 8 weeks of treatment, adolescents and young adults with solid tumors experience     substantial fatigue that is not related to sleep disruption. Fatigue can contribute to many     adverse outcomes including poor treatment adherence, reduced social activities, depressive     symptoms, behavior problems, and poorer quality of life. Unfortunately, no definitive     intervention to reduce fatigue has been developed for pediatric oncology patients.     Investigators propose a study to estimate the feasibility and acceptability of bright light     therapy as an intervention to decrease fatigue in adolescents and young adults who are newly     diagnosed and receiving treatment for solid tumors, including lymphoma.   "
65444|NCT02429050|"     Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary     Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is     recommended in clinical practice guidelines, but questions concerning benefits and concerns     about respiratory adverse effects remain. For example, the effect on health-related quality     of life and functional capacity is unknown. In one-third of the patients oral sustained     release morphine (morphine SR) doesn't relieve dyspnea and it remains unknown whether     severity and descriptors of breathlessness may predict a response to morphine. Finally,     cost-effectiveness of morphine SR in this patient group is unknown. Therefore, prescription     of morphine to patients with COPD is limited.      Objectives of this double blind randomized controlled trial are to study the effect of oral     administration of morphine SR on health-related quality of life, respiratory adverse effects,     and functional capacity; to explore whether description and severity of breathlessness are     related with a clinically relevant response to morphine and to analyse the cost-effectiveness     of morphine SR. The study population will consist of 124 clinically stable outpatients with     COPD and severe dyspnea despite optimal pharmacological and non-pharmacological treatment.   "
65445|NCT02429037|"     The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene     combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of     unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and     active-controlled study.   "
65512|NCT02428166|"     The purpose of this retrospective study is to assess corneal changes (keratometry,     pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral     crosslinking treatment compared to the untreated fellow eye. The corneal measurements     obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating     scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and     ocular surgeries as potential factors involved in treatment outcome are also evaluated.   "
65447|NCT02429011|"     The purpose of this study is to research the effects of ketamine on brain function in     patients with Major Depressive Disorder (MDD). This study is an ancillary MRI neuroimaging     study being conducted in patients with MDD who are enrolled in a separate clinical trial.     Healthy control volunteers are also enrolled. No drug or other intervention is given as part     of this protocol per se.      To study brain activity related to emotion, the study team will use a technology called     functional MRI (fMRI), which is a method for evaluating the flow of blood in the brain using     a powerful magnet. fMRI does not involve exposure to radiation.      Patients will be shown a sample of images on a computer screen designed to bring about an     emotional reaction. The MRI machine will then take a number of pictures of your head. By     computer analysis, this machine is able to create a picture of your brain's activity. There     are several tasks during scanning that involve looking at various images that represent     different emotions, and the study team will be monitoring brain activity during these tasks.      Patients will be scanned before and 24 hours after receiving ketamine (as part of a separate     study) to analyze treatments effects. These scans are compared to depressed patients who did     not receive ketamine, as well as to healthy controls.   "
65448|NCT02428998|"     Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and     comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce     body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve,     fatigue, and determine the impact on biological age.   "
65449|NCT02428985|"     The primary objective in this study is to collect post-marketing information on Riociguat     safety.Thus, the information on adverse events (AEs) and adverse drug reactions (ADRs) that     occur within the first 12 months and in the following 6 -year observation at most, after     starting Riociguat treatment under the routine clinical practice will be collected.      The secondary objectives are collecting information on Riociguat effectiveness, such as     6-Minute Walking Distance (6MWD) Test. Since it is assumed that Riociguat is for long-term     use, information on Pulmonary Arterial Hypertension (PAH) clinical worsening will also be     surveyed once a year.   "
65450|NCT02428972|"     Primary brain tumors are highly associated with neurocognitive deficit and poor quality of     life. There are number of studies indicating that brain tumors and their treatment modalities     are often related to cognitive dysfunction. Apart from primary brain lesions, deficit can     also occur because of Surgery, Radiotherapy, Chemotherapy, Antiepileptic and Corticosteroid     treatment.Anaesthesia can also add to cognitive deficit in these patients. According to Ali     et al. propofol provides better cognition scores compared to sevoflurane than isoflurane. The     primary aim of their study was to compare the effects of 3 anesthetic regimens on     hemodynamics and recovery characteristics of the patients. However in another study by Magni     et al., the authors found that there is no difference in early cognitive function between     sevoflurane and propofol. The aim of this prospective, randomized, open-label clinical trial     was to compare clinical properties of sevoflurane-fentanyl with propofol-remifentanil     anesthesia in patients undergoing supratentorial intracranial surgery. However both these     studies evaluated the early cognitive function. The primary endpoint was to compare early     postoperative recovery and cognitive functions within the two groups. They also evaluated     hemodynamic events, vomiting, shivering, and pain. The literature is scarce on the severity,     incidence and effect of anaesthetics on cognition and quality of life of these patients.     Since most of the patients of brain tumor cannot be cured with surgery alone, improvement of     quality of life and palliative care of the symptoms and cognitive function are important part     of the treatment. Now the cognitive function has also been considered as an independent     prognostic factor in the survival of patients of brain tumor. Cognitive function can also be     related to tumor laterality. Patients with tumors in left hemisphere will have lower scores     on verbal tests, whereas tumor in right hemisphere will have lower scores on facial     recognition tests. Patients with tumors in the left hemisphere report more difficulty     concentrating and those with right-hemisphere lesions,report more tension. Patients with     primary brain tumors also experience serious challenges to their quality of life (QOL). These     patients may face motor deficits, personality changes, cognitive deficits, aphasia, or visual     field defects.   "
65451|NCT02428959|"     This research is being done to see if a study drug called amyl nitrite can be helpful with     diagnosing different disorders affecting the lower esophageal sphincter in patients with     dysphagia (difficulty swallowing foods) undergoing high resolution esophageal manometry     (HRM).      Dysphagia may be one of the symptoms of a condition known as idiopathic achalasia. Achalasia     is a disorder of the esophagus, the tube that carries food from the mouth to the stomach.     This affects the ability of the esophagus to move food toward the stomach. Pseudoachalasia is     a secondary form of achalasia, which has very similar symptoms but is caused by different     reasons. Because the treatments for achalasia and pseudoachalasia are different, it is     important to correctly diagnose each condition. At this time, there is no way to distinguish     the two with the current tests used at Johns Hopkins.      Amyl nitrite relaxes vascular smooth muscle and has been studied previously as a potential     means to separate achalasia from pseudoachalasia. Amyl nitrite is approved by the Food and     Drug Administration (FDA) for the treatment of cardiac angina. It is not approved for use in     motility testing and its use in this study is considered investigational. Investigators hope     that the results from the proposed study could have significant clinical implications for     patient management by helping doctors distinguish between achalasia and pseudoachalasia and     allow them to choose appropriate treatment.      Patients with dysphagia (difficulty swallowing foods) undergoing routinely scheduled high     resolution esophageal manometry (HRM) may join this study.   "
65452|NCT02428946|"     In this study the investigators will examine the effect of dopamine (bromocriptine) on     insulin sensitivity in lean and obese subjects. Furthermore, the investigators will examine     whether the timing of bromocriptine administration has influence on insulin sensitivity.      To do so, the investigators will include lean and obese subjects who will use 2 times 2 weeks     bromocriptine. In randomized order, they will use it in the morning or in the evening.      The investigators will examine insulin sensitivity by performing a 7-point oral glucose     tolerance test.      Furthermore, the investigators will examine energy expenditure and subjects will keep track     of their eating behaviour in the 3 days before each study visit.   "
65453|NCT02428933|"     In this study the investigators will investigate the effect of dopamine (bromocriptine) on     Brown Adipose Tissue in lean, young, healthy males.      The investigators will also examine energy expenditure, body temperature and insulin     sensitivity as measurements of Brown Adipose Tissue activity.   "
65464|NCT02428790|"     Empirically patients with acquired brain injury (ABI) are often constipated. This is a major     clinical issue. Nevertheless, this has only been sparsely studied.      The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI,     and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in     these patients, and associations between HRV and GITT are investigated.   "
65780|NCT02424682|"     This study was designed to evaluate safety and tolerability of Herceptin as treatment for     patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast     cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse     events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive     metastatic breast cancer.   "
65454|NCT02428920|"     The Grenada Heart Project (GHP) conducted an observational study within a randomly selected     adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical,     biological and psychosocial determinants of the cardiovascular health in Grenada, in order to     develop and implement a nationwide cardiovascular health promotion program.      The sample of 2,827 adults was randomly selected from the national electronic voter list. The     main outcome measures were self-reported cardiovascular disease and behavioral risk factors,     anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids,     and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity,     hypertension and diabetes significantly exceeding those seen in the U.S.      Since the completion of this assessment, an additional effort has contributed significantly     to the current project. A parallel community health-promotion project was carried out in     Cardona, Spain called the Cardona Integral Fifty-Fifty project with 80 subjects. The     preliminary results of the Cardona study have a shown that peer motivation may significantly     improve healthy behaviors and thus modify cardiovascular risk.      The GHP CHANGE community -based intervention aims to promote positive behaviors and focus     more on what creates health, rather than what prevents sickness. It is built on the     foundations of social support, assessing whether people going through similar challenges will     support each other, work together to identify and address barriers to success, and motivate     each other to move forward. In this program we test for the impact of promotion of healthy     lifestyle behaviors through peer motivation on blood pressure, physical activity, eating     behavior, weight, and smoking.   "
65455|NCT02428907|"     Some patients experience a degree of pain and discomfort during endoscopic examination of the     large bowel. Sedatives and analgesics may be administered in low doses. Excessive dosage or     intense pain may lead to hypotension and impaired level of consciousness. The purpose of the     present study was to determine if simulation training of endoscopy staff in preventing pain     and handling acute complications through effective teamwork could improve the quality of     colonoscopy from the patients' perspective.   "
65456|NCT02428894|"     The purpose of this study is to characterize changes in the plasma proteome over time     following left ventricular assist device (LVAD) implantation.   "
65457|NCT02428881|"     Hypothesis / aims of study      Urinary retention is uncommon in young women, and one cause is a primary disorder of urethral     sphincter relaxation, characterised by an elevated urethral pressure profile and specific     findings in the urethral sphincter EMG (Fowler's Syndrome). Women may present with symptoms     of obstructed voiding or complete urinary retention. Clean intermittent self-catheterisation     is often painful to perform and currently, the only treatment to show benefit is sacral     neuromodulation. This aim of this pilot study is to assess the efficacy of urethral sphincter     injections of botulinum toxin, defined as improvement of flow rates by more than 50%,     improvement in residual volume and scores on the IPSS questionnaire, and safety, in women     with Fowler's Syndrome.      Study design, materials and methods In this open label pilot institutional review board     approved study, ten women with a primary disorder of urethral sphincter relaxation (elevated     urethral pressure profile (UPP), sphincter volume and abnormal EMG) presenting with     obstructed voiding (n=5) or in complete urinary retention (n=5) are recruited from a single     tertiary referral centre. Baseline symptoms are being assessed using the IPSS questionnaire,     and urinary flow and post-void residual volume were measured. After 2% lidocaine injection,     100U of onabotulinumtoxintypeA is being injected into the striated urethral sphincter,     divided on either side, under EMG guidance. Patients are being reviewed at weeks 1, 4 and 10     post-treatment and symptoms are reassessed using the IPSS questionnaire, and urinary flow and     post-void residual volume are being measured. The UPP is being repeated at week 4.   "
65458|NCT02428868|"     It is a prospective randomized controlled study aiming to test if tranexamic acid combined to     intravenous iron before and after surgery for hip fracture in elderly can decrease     peri-operative red cell transfusion.   "
65459|NCT02428855|"     This research study is studying Dasatinib as a possible treatment for cancer of bile ducts.   "
65460|NCT02428842|"     Prospective Multicentric European trial for Cervical cancer, not previously treated, with     tumour biopsies, and blood collection for molecular analysis at predetermined time points.   "
65461|NCT02428829|"     This study looks to examine the effect of attempting initial postoperative walking with a     patient following a total hip replacement. Currently patients rest in bed for approximately     24 hours following their operation before walking. The intervention group would aim to     commence walking at between 4-6 hours after their operation.      Outcome measures to be examined would be: length of hospital stay, patient experience of     physiotherapy treatment, the time taken for patients to reach functional milestones and     number of postoperative medical complications.      The study is designed as a randomised controlled trial where participants would be separated     randomly into two groups. One group would form the intervention group and start physiotherapy     and attempted walking 4-6 hours after their operation. The other group would form the control     group and would remain on the current standard rehabilitation protocol.   "
65462|NCT02428816|"     Based on previous promising results, the next step for the validation of a multimodal MRI     method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to     test whether the multimodal neuroimaging is able to discriminate at the individual level,     patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic     Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes     over time for the two diseases, according to imaging, neuropsychological and other clinical     data.   "
65463|NCT02428803|"     Home dialysis patients must be seen in a face to face visit on a monthly basis. For patients     who live remotely these visits may impact their quality of life due to the amount of time     needed to attend these visits. The central hypothesis is that implementation of telemedicine     visits as a substitute for the 2 out of 3 monthly face-to-face visits over a 6 month period     will improve quality of life as judged by the quality of life (QoL) indices Kidney Disease     Quality of Life - Short Form and the Illness Intrusiveness Ratings Scale when compared to QoL     scales taken during a time period when the patient is on standard of care.   "
65817|NCT02424201|"     Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active     management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence     the need for an effective oxytocic in third stage of labour.   "
65467|NCT02428751|"     The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone     (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large     B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac     toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among     elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a     prolonged circulation time and unique toxicity profile. Previous single arm studies of     elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional     doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the     novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow     suppression and less cardiac toxicities, while maintaining the efficacy. However, the     efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head     compared in a randomized study. The aim of this study is to compare the efficacy and safety     of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and     prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and     prednisone) in previously untreated elderly patients with DLBCL.   "
65468|NCT02428738|"     Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year     worldwide and affects people of all ages. These epidemics typically occur in the winter     months, and can result in substantial morbidity and mortality in persons at risk. Pregnant     women may be more susceptible to morbidity and mortality associated with influenza infection.     This increased risk may result from several factors including increased heart rate, stroke     volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function.     Immunization of women during pregnancy can help to prevent infection in the woman herself and     may also offer protection to the infant in two ways: by the passage of antibodies from mother     to the fetus during pregnancy, and by preventing infection in the mother and therefore     decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee     on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver     during influenza season because they will become household contacts of their newborn. Ideal     timing of vaccination occurs in October or November since influenza outbreaks typically occur     throughout the winter months. Despite the Canadian and American guidelines for influenza     vaccination during pregnancy, it is unclear how many women are offered and/or actually     receive the vaccine while pregnant. There is, however, evidence that women will accept the     vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's     Hospital, it was found that 42% of women not only accepted but also received the influenza     vaccination when offered. Innovative techniques will be required to continue to increase     vaccination rates among vulnerable populations, including pregnant women. The purpose of the     present study is to determine if the use of electronic reminders (text messages) increases     the likelihood of receiving the influenza vaccine among pregnant women.   "
65469|NCT02428725|"     This study will try to determine if the measure of the platelet reactivity of the patients     receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary     angioplasty allows to predict the hemorrhagic risk.   "
65470|NCT02428712|"     The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated     dose/recommended Phase 2 dose, and efficacy of PLX8394.   "
65471|NCT02428699|"     This study is designed to compare the incremental area under the curve from 0 to 24h     (iAUC0-24h) of plasma levels of n-3 fatty acids (sum of total and free eicosapentaenoic acid     (EPA) and docosahexaenoic acid (DHA)) after ingestion of an emulsified product and a     non-emulsified reference control of free flowing cod liver oil at the lowest appropriate dose     that is practically acceptable, and as near as possible to the test products' recommended     daily dose.   "
65472|NCT02428686|"     Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic     syndrome. It generates an increased rate of morbidity and mortality in this population of     patients whose median age is high and the rate of co-mobidities important. The historical     treatment is limited to transfusion support with a significant impact on quality of life and     the incidence of secondary haemosiderosis, which contributes to the emergence of     co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid     response in 40-60% of patients treated.      In this trial, the investigators intend to study the interest of a treatment with epoetin     beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with     IPSS score <1.      In addition to studying the erythroid response, the investigators will measure the impact on     quality of life and functional performance.      Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24     weeks of treatment.   "
65473|NCT02428673|"     Children with neuromuscular disabilities and limited ambulation are at significant risk for     decreased bone mineral density (BMD) and increased incidence of fracture. This is caused, in     part, by low levels of load experienced by the skeleton due to a child's functional     limitations. Low BMD has been shown to be predictive of fracture, and in fact, fractures     usually occur without significant trauma in children with neuromuscular conditions. The     discomfort and distress from fractures in this population are considerable, and the     associated costs to the family and healthcare system are substantial. Numerous interventions     have been devoted to improving BMD in these children. Stationary assisted standing devices     are widely used and represent the standard-of-care. However, evidence supporting this     approach is limited due to inadequate study designs with insufficient numbers of patients.      This study will use load-sensing platforms in patients with neuromuscular conditions.     Successful completion of this pilot study will assist in the development of a future     multicenter clinical trial to definitively determine relationships, if any, between passive     standing and measures of BMD, fracture incidence, pulmonary function, and health-related     quality-of-life measures in children with a variety of neuromuscular disabilities (e.g.,     spinal muscular atrophy, cerebral palsy, muscular dystrophy, spina bifida, Rett syndrome).      Hypothesis: Assisted standing treatment program will gradually increase their duration of     standing by up to 75% after the baseline phase.   "
65818|NCT02424188|"     This study will determine whether an 18-month practical tobacco smoking cessation program     integrating weight management counseling and exercise will be superior to treatment as usual     in achieving prolonged smoking abstinence in persons with serious mental illness.   "
65474|NCT02428660|"     This randomized controlled trial will evaluate whether the use of pharmacogenetic testing     through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy     problems. More specifically, cytochrome DNA testing, which provides information with regards     to participant specific metabolism of medications, will be used in the evaluation of     participant medication regimens. The overall aim of the project is to evaluate if the     addition of genetic CYP testing to a standardized MTM Program provides increased clinical     value. To answer this question, the investigators will look at the drug therapy problems     (DTPs) identified by the genetic test compared to those DTPs discovered without the test.   "
65475|NCT02428647|"     The study will be conducted as a community-based, randomized, placebo-controlled, trial with     four study groups. The overall objective of the study is to determine the optimal method for     delivering zinc to young children, both for the prevention of zinc deficiency and treatment     of diarrhea. In particular, the investigators plan to compare the impact on physical growth,     morbidity, micronutrient status, immune function, environmental enteric dysfunction, parasite     burden and hair cortisol concentration of: 1) daily preventive zinc supplementation as a     micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc supplementation as     dispersible tablets; 4) therapeutic zinc supplementation as dispersible tablets given in     relation to episodes of diarrhea.      In addition to the major outcomes mentioned above, the investigators will monitor adherence     to the interventions, neuro-behavioral development, and the occurrence of any adverse events.   "
65476|NCT02428634|"     The objective of the study is to evaluate the effects of Program SI! for Elementary in     different times of exposure for childrens and their immediate environment (teachers and     parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain)     were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or     keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes     from baseline of questionnaire scoring of children, their parents and teachers in regards to     a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular     markers derived from blood pressure and anthropometry.   "
65477|NCT02428621|"     The aim of this prospective, multicentric, randomized, open-label study is to assess the     efficacy of the removable Twicare® as mandibular propulsive appliance in children aged from 7     to 12 years old in the course of their orthodontic treatment, showing its noninferiority with     the removable Herbst. One untreated group will be included to control the internal validity     of the study as recommend in noninferiority trials. Patients will have a follow-up every two     months during 6 to 12 months as planned in routine care.   "
65478|NCT02428608|"     The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified     Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated     with corrugator and procerus muscle activity in adult subjects.   "
65479|NCT02428595|"     Multi-center, prospective, within-subject control, open label clinical trial to evaluate the     durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of     use.   "
65480|NCT02428582|"     To compare the outcome of revascularisation the gastrointestinal arteries using covered     stents compared to bare-metal stents in patients with CGI.   "
65481|NCT02428569|"     This study evaluates the effectiveness of patient educational materials (a book and DVD) to     help patients with chronic kidney disease make early, shared, and informed decisions about     kidney replacement therapy. Half of the participants will receive the educational materials     and half will receive usual care from their doctors.   "
65482|NCT02428556|"     OBJECTIVE: To learn how people understand language used by the FDA to describe certain newly     approved medications called breakthrough drugs.      BACKGROUND: FDA allows drugs to be designated as breakthrough if there is preliminary     evidence that it may offer a substantial improvement over available therapies. But consumers     (and prescribers) may mistake the word — which in this context means very preliminary promise     and lots of uncertainty - to mean the drug is proven to be much more effective or much safer     than existing drugs.      METHODS: Internet survey (with colleagues from Carnegie Mellon University) using Amazon     Mechanical Turk - a web tool that recruits people willing to do surveys     (https://www.mturk.com/mturk/welcome). Participants will be asked to read a short scenario     about a new drug (facts are based on a real drug but the investigators use a fictional name)     and answer questions about how well they think the drug works, how safe it is, etc. People     will be randomized to one of 5 versions of the scenario differing in how explicitly they     explain what breakthrough means. The information in the scenario is drawn from FDA's own     press release about the drug.   "
65483|NCT02428543|"     This project is part of a joint ALFA and GOELAM strategy aiming to improve the survival of     patients with newly diagnosed Acute Myeloid Leukemia (AML) aged 18-70 years. The basis of     this strategy is to evaluate intensified conventional chemotherapy and targeted drugs in     selected disease-risk subgroups of adult patients with non promyelocytic AML. Participation     will be proposed to almost all adult patients in France aged 18-70 years and diagnosed with     AML.      FLT3 genetic alterations include FLT3 somatic point mutations within the second tyrosine     kinase domain and internal duplications of the juxta-membrane domain. This alteration is     refered to as FLT3-ITD. The FLT3-ITD mutation is found in around 30% of patients with     cytogenetically normal AML. Patients with the FLT3-ITD genotype have been reported to have a     poor outcome when treated with conventional chemotherapy with an estimated 4-year     relapse-free survival of 25% (Schlenk et al. N Engl J Med 2008). More recently, the     prognostic relevance of FLT3-ITD has been studied in the context of integrated genetic     profiling. This confirmed the genetic complexity of AML and also that FLT3-ITD was associated     with reduced overall survival in intermediate-risk AML. A multivariate analysis of several     genetic alterations revealed that FLT3-ITD was the primary predictor of patient outcome.     FLT3-ITD mutations were classified in 3 categories: 1) FLT3-ITD with +8, TET2, DNMT3A or     MLL-PTD mutations (3-year OS 14.5%); 2) FLT3-ITD with wild type CEBPA, TET2, DNMT3 and     MLL-PTD (3-year OS 35.2%) and 3) FLT3-ITD with CEBPA mutations (3-year OS 42%) (Patel JP et     al. N Engl J Med 2012). However, FLT3-ITD was not a predictor of response to induction     therapy, allowing the introduction of targeted therapies after the induction course.      Several FLT3 inhibitors have been evaluated or are currently being tested in the setting of     relapsing AML. In most trials to date, patients were only eligible if the FLT3-ITD mutation     was present. Disappointing results were reported with the first generation of FLT3     inhibitors, including lestaurtinib (CEP-701), midostaurin (PKC-412) and sorafenib. Second     generation FLT3 inhibitors such as quizartinib (AC220) are currently under investigation with     promising results. However, the hematologic toxicity of AC220 will likely present a major     limitation in evaluating AC220 combined with standard or high-dose chemotherapy.      Ponatinib (AP24534) is a third generation tyrosine kinase inhibitor targeting the BCR-ABL     tyrosine kinase domain. Ponatinib was rationally designed with an extensive network of     optimized molecular contacts and triple bonds to accommodate the T315I mutation, a major     cause of resistance to tyrosine kinase inhibitors in chronic and advanced phase chronic     myelogenous leukemia (CML). Ponatinib also inhibits SRC (IC50: 5.4 nM) and members of the     VEGFR, FGFR, and PDGFR families of receptor tyrosine kinases (O'Hare T, Cancer Cell 2009).     Despite low activity against FLT3 based on the IC50 value (FLT3 IC50: 12.6 nM compared to BCR     IC50: 0.37 nM), ponatinib has recently been reported to have significant cellular activity     against the MV4-11 cell line which harbors an FLT3-ITD activating mutation. Ponatinib-induced     apoptosis was maximal at 10 nM in vitro and a single dose of 5 and 10 mg/kg had a strong     inhibitory effect in vivo in mice bearing MV4-11 xenografts. Primary blast cells from 4     FLT3-ITD AML patients were also tested and ponatinib reduced their viability (IC50: 4 nM)     whereas no activity was shown on FLT3-ITD-negative blast cells (Gozgit JM et al. Mol Cancer     Ther 2011).      Preliminary data from the phase I clinical trial showed that 15 mg ponatinib was associated     with a Cmax of 51.1 nM. Cmax was increased to 111 nM and 149 nM in the 30 mg and 45 mg     cohorts respectively. The trough concentrations were 55.3 nM and 61.9 nM for the 30 mg and 45     mg doses respectively (Ariad clinical investigator's brochure, version 3). Results from the     ongoing phase II trial in CML patients suggest that the hematological toxicity profile of     ponatinib is comparable with that of nilotinib or dasatinib, both of which have been     successfully combined with conventional chemotherapy.      Investigators thus aim to combine ponatinib with cytarabine in FLT3-ITD AML patients in first     complete remission.   "
65484|NCT02428530|"     This study assessed the relationship between pregnant women, partner support, and cigarette     and alcohol use in pregnancy.   "
65485|NCT02428517|"     This study is a prospective multicenter observational study to evaluate the feasibility and     the efficacy of the conditioning regimens which are modified by the donor differences and the     age of recipients among patients who will receive allogeneic hematopoietic stem cell     transplantation in their 1st or 2nd hematologic complete remission (CR).   "
65486|NCT02428504|"     It is not universal that terminally ill patients choose surrogate in the event of     disagreement between the treating physician and the surrogate at the end of their lives.     There are several factors that influence the terminally ill patient's decision to choose a     decision maker at the end of his / life.   "
65487|NCT02428491|"     The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's     DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2,     3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a     dose of Hep B vaccine at birth or within 1 week after birth.      Primary Objective:        -  To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep          B-PRP-T combined vaccine in Vietnamese infants and toddlers      Secondary Objective:        -  To evaluate the immunogenicity of the study vaccine one month after the third dose          primary series.        -  To demonstrate the non-inferiority of the immune response to all antigens induced by the          study vaccine in Vietnamese infants one month after the third dose in a 3 dose primary          series with the immune response to all antigens induced by the same study vaccine          outside Vietnam        -  To describe the persistence of all antibodies before receipt of the booster vaccination.   "
65513|NCT02428153|"     The purpose of this study is to investigate the acute effects of two different types of     muscle stretching (static and dynamic) on muscle-tendon unit of gastrocnemius muscle by     ultrasound and to follow how long the stretching effects are sustained.   "
65566|NCT02427464|"     The purpose of this study is to determine the safety and efficacy of bilateral intramuscular     injections of VM202 versus placebo in the treatment of painful diabetic neuropathy.      A total of 477 subjects will be randomized in a 2:1 ratio to one of two treatment groups:      Treatment - VM202 - 318 subjects Control - Placebo (VM202 vehicle) - 159 subjects      Randomization will be stratified by current use of gabapentin and/or pregabalin.   "
65488|NCT02428478|"     Obstructive sleep apnea (OSA) is common and has major health implications but treatment     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared     to normal participants. Until recently, the search for medicines to activate pharyngeal     muscles in sleeping humans has been discouraging. However, exciting new animal research has     shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle     activity to waking levels. In this protocol the investigators will test the effect of     desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)     on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.   "
65489|NCT02428465|"     Pediatricians' provision of parenting-focused anticipatory guidance often does not meet     parents' needs; the few studies that have investigated primary-care based strategies to     promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting     their generalizability. Therefore, the Purposeful Parenting was developed as a universal     program of enhanced anticipatory guidance. At each well-child visit in the first year of a     child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance     and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills,     brain development and the importance of responsive parenting; and 2) a reminder item (e.g.,     a Smile at Me onesie) that allows for in-office role modeling and promotes practicing of an     age-specific, nurturing parent-child interaction. If an in-office intervention is missed     (e.g. parent cancels visit, interventionist out sick) the intervention will be delivered by     telephone if possible by the site-based clinical interventionists and the reminder items     will be mailed.   "
65490|NCT02428452|"     The Social ABCs is an innovative parent-mediated intervention for toddlers with confirmed or     suspected Autism Spectrum Disorder (ASD). The intervention draws on what is known about core,     early emerging impairments in ASD, and on evidence-based Pivotal Response Treatment (PRT) and     associated parent training programs for enhancing development in children with ASD.     Completion of a comprehensive pilot study set the stage for a randomized control trial (RCT)     of the Social ABCs. The purpose of this RCT is to evaluate the efficacy of the Social ABCs     intervention program on improving spoken language skills and positive parent-child emotion     sharing in toddlers with signs of or a diagnosis of ASD.   "
65491|NCT02428439|"     The objective of this study is to identification of genetic markers and predictors of     antidepressant-induced suicidality in youth depression. Participants who take the     standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8     weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4)     and visit 4 (week 8)   "
65492|NCT02428426|"     To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal     tissue.   "
65493|NCT02428413|"     The purpose of this study is to evaluate anesthetic gas in the PACU within patient and     caregiver breathing zones.   "
65494|NCT02428400|"     Methodology:      This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in     patients that are currently being treated for chronic HBV infection. For all cohorts,     patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate     (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled   "
65495|NCT02428387|"     With the number of Canadians with Alzheimer's disease and related dementias (ADRD) growing,     supporting family care partners of persons with ADRD is critical. Family caregivers provide     about 90 per cent of in-home care for persons with ADRD, and the care is often difficult due     to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and     multiple chronic conditions (MCC) experience significant, complex, distressing transitions     such as changes to their environment, roles and relationships, physical and mental health,     isolation, and taking on new tasks. An online Transition Toolkit (My Tools 4 Care) was     developed for family caregivers of persons with ADRD and MCC living at home, to support     caregivers through transitions and increase their self-efficacy, hope, and quality of life     (QOL).      Through this pragmatic mixed methods randomized controlled trial the investigators expect to     find that family caregivers receiving the online My Tools 4 Care Toolkit will show greater     improvement in hope, self-efficacy and QOL, at no additional cost from a societal     perspective, compared with those in an educational control group. Following baseline data     collection 180 participants will be randomly assigned to one of the groups with repeated     measures at one, three and six months.   "
65496|NCT02428374|"     The fascinating role of lymphocyte subtypes in the development of coronary artery disease may     be a new strategic target for understanding and therapy of acute myocardial infarction. The     determinants of cell viability are unknown, postulating that they arise from factors not only     related to microcirculation or energy expenditure, but also to inflammatory and immune     responses. Furthermore, the intense mobilization of progenitor cells secondary to myocardial     infarction triggers large lymphocyte proliferation that colonizes plaques in development,     contributing to recurrent ischemic outcomes. This project aims to evaluate the immune and     metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary disease     progression.   "
65497|NCT02428361|"     This is a prospective, open label pilot study in which patients with symptoms of acute or     chronic pouchitis will receive FMT therapy delivered via pouchoscopy. The investigators     hypothesize that FMT is a safe and effective treatment for patients with pouchitis. Our aims     our:        1. To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial          Transplantation.        2. To determine if endoscopic appearance of ileal pouch improves following treatment by          Fecal Microbial Transplantation.   "
65511|NCT02428179|"     Surgical site infection (SSI) is the most frequent complication in patients that undergo     abdominal surgery. A previous prospective observational study in 167 patients undergoing     elective open abdominal procedures showed that case-relevant communication protects from     organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the     procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical     applicable intervention structured briefing using the StOP protocol has been developed and     was tested in pilot experiments. This intervention aims at improving case-relevant     communication during the procedure and to reduce excess case-irrelevant communication at the     end of an operation.      The hypothesis is: structured briefings during an operation reduce the incidence of SSI after     surgery.   "
65498|NCT02428348|"     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with     user-friendly active dry electrodes that meets the expectations of the users regarding     comfort and esthetics, without losing sight of the functional and technical demands for     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that     hospital admission in the EMU can be avoided for some patients and an increasing number of     patients can be examined.      Phase 3 of this Project will be divided into Phase 3a and Phase 3b.      In Phase 3b of the project epilepsy patients and their family will be interviewed about     different EEG-cap models in development. This interview is anticipated to take approximately     1 hour.      Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.      The results of the interviews will be analysed by the design company pilipili nv.   "
65499|NCT02428335|"     Sunitinib is a chemotherapy approved by the FDA as a standard of care treatment for renal     cell carcinoma (RCC). Fatigue is a very common side effect of sunitinib that frequently     causes dose reductions. The cause of this fatigue remains unclear. This study will use a     special type of scan to study sunitinib-induced fatigue in relation to exercise.   "
65500|NCT02428322|"     Epidemiological and observational studies have linked vitamin D deficiency with increased     asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with     increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated     with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower     airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and     allergy and asthma appears to be stronger in children than adults, with some even suggesting     that childhood asthma may may be caused by VDD.   "
65501|NCT02428309|"     The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect     of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their     lupus. Targeting cutaneous disease offers the ability to control background therapy, readily     detect clinical effects, and perform research analyses not only in blood but also skin.     Safety, disease activity, and mechanism of Tregs will be evaluated. The intent is to support     dose selection for a future larger efficacy trial in lupus.   "
65502|NCT02428296|"     Background:      - PIK3CA-related overgrowth spectrum (PROS) is caused by changes in the PIK3CA gene. This     gene makes a protein that communicates with other proteins in the body to cause cells to     grow. Alterations in PIK3CA change the chemical signals in the body and cause overgrowth in     fatty, vascular and other tissues. Sirolimus is a drug that reduces the signals sent by one     of the proteins in this chemical signaling pathway. Researchers want to learn whether the     drug sirolimus can reduce or stabilize some of the overgrowth that patients with PROS     experience.      Objectives:      - To measure how the overgrowth of patients with PROS changes over time and whether taking a     drug called sirolimus can reduce or stabilize a person s overgrowth.      Eligibility:      - People ages 3 to 65 years old with a confirmed mutation or alteration of the PIK3CA gene in     the person s affected tissues (a somatic mutation).      Design:        -  Participants will be screened with medical history and genetic counseling.        -  First 6 months: Participants will have their overgrowth monitored.        -  Next 6 months: Participants will take sirolimus once or twice a day.        -  Participants will have to visit the clinic several times, and stay in the area for 4 5          days each time.        -  Participants will have a one month-long visit to the clinic.        -  During clinic visits, participants will have:        -  Blood and urine tests.        -  Photographs of their physical features.        -  Scans, including an MRI and DEXA, and possibly x-rays and CT scans.        -  For the MRI and CT scans, participants will lie in a machine that takes pictures of          their body.        -  The DEXA involves a small amount of radiation.        -  They may have:        -  Non-invasive heart function tests.        -  Lung function tests.        -  Participants will have several blood and urine tests between visits.        -  Participants will complete surveys and keep a diary of their treatment and side effects.        -  Participants may visit other health specialists or undergo other tests based on side          effects.        -  One month after stopping the study drug, participants will have 1 clinic visit.   "
65503|NCT02428283|"     Emergence agitation is a common problem in children during recovery from sevoflurane     anesthesia. Pain is considered as a cause of postoperative emergence agitation and     compounding factor of agitation assessment in children. The purpose of this study was to     investigate the effect of scalp nerve block on the emergence agitation in children undergoing     nevus surgery during sevoflurane anesthesia.   "
65504|NCT02428270|"     This is a phase 2 study (the second phase in testing a new drug or combination to see how     effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib.      The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib     in patients with advanced pancreatic cancer.   "
65505|NCT02428257|"     The study evaluates the potential beneficial effects on hemodynamics when hypobaric     bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for     surgical repair of hip fracture in elderly patients. Half of the patients will receive     hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic     data will be compared.   "
65506|NCT02428244|"     It is well known that smoking has deleterious effects to fracture/broken bone outcomes.     Complications associated with smoking can be mitigated by smoking cessation. Initiating     smoking cessation programs while patients are in the inpatient hospital setting has shown to     be an opportune time to enroll patients in a smoking cessation program. The goal of this     study is to determine if inpatient smoking counseling with/without follow-up is superior to     the standard smoking cessation information associated with admission to a hospital facility.   "
65507|NCT02428231|"     The primary objective of the study is to assess whether a 6-week titration (compared with a     1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF     [Tecfidera])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple     sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration     (compared with a 1-week titration) is effective in reducing the average severity and duration     of GI symptoms over 12 weeks of DMF treatment in this study population.   "
65508|NCT02428218|"     The primary objective of the study is to assess the efficacy of oral BG00012 as compared with     placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The     secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and     to compare the effect of BG00012 with placebo on additional clinical and radiological     measures of disease activity.   "
65509|NCT02428205|"     The purpose of this study is to explore the effects of propranolol in combination with early     intensive behavioral intervention on social interaction, and secondarily on language,     anxiety, adaptive behaviors, and global function in children with autism in a double-blinded,     placebo-controlled pilot trial.   "
65510|NCT02428192|"     This phase II trial studies how well nivolumab alone or in combination with ipilimumab works     in treating patients with uterine cancer that has spread to other places in the body and     usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as     nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.   "
65514|NCT02428140|"     The overall aim of this trial is to determine the most cost effective approach to diagnose     paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke.      A summary of the rationale for this study is as follows:        1. Recently completed randomized trials of cardiac monitoring following stroke have          established that PAF is more common than previously recognized in cryptogenic stroke.        2. The majority of TIA/stroke patients will have at least one potential stroke mechanism          identified by the time etiologic investigations completed.        3. Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel          atherosclerosis) is clinically important since appropriate anticoagulation for AF          reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic          strokes.        4. There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no          cost effectiveness data        5. The rates of PAF in strokes with known causes (SKC) have not been well characterized.      PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first     line investigations to detect PAF in patients with recent stroke and TIA. The study will also     assess whether a pivotal trial is feasible and warranted.      The principal research questions to be addressed in this study will be:        1. What is the relative cost-effectiveness as a first line investigation of long-term          implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external          event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically          actionable AF in following TIA/stroke.        2. What is the feasibility, patient compliance, diagnostic accuracy and rates of AF          detection (>30 seconds) of ILR compared to the ELR strategies.   "
65515|NCT02428127|"     The purpose of this study is to investigate the impact of a beverage containing carbohydrate     powder fortified with micronutrients on agility, speed, and power in school going children   "
65516|NCT02428114|"     In patients with early-stage breast cancer, chemotherapy has substantially improved survival     rates for breast cancer patients. Improvements in outcomes, however, are compromised by the     considerable toxicities associated with chemotherapy, most notable being neutropenia.     Neutropenia is the presence of abnormally few white blood cells, leading to increased     susceptibility to infection and can require hospitalization and need for intravenous     antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with treatment     delays and dose reductions, potentially compromising treatment efficacy. Patients can receive     medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a     daily injection for 5, 7, or 10 days. Since there is genuine uncertainty amongst healthcare     professionals as to which administration schedule of Neupogen is better, investigators are     performing a randomized study in which patients are put into a group by chance to give     participants one of three standards of Neupogen daily injection. Neupogen can cost     approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of     treatment this can cost $16,000 compared to a 5 day prescription which would cost half this.     In addition to cost savings, many patients are not able to give themselves injections on a     daily basis and require nursing resources which are utilized at high-cost. This study will     use an integrated consent model that involves an oral consent rather than a written     informed consenting process in order to increase the number of patients who may participate     while performing a study at a lower cost. While determining the optimal treatment will     improve patient comfort and acceptability, using the minimal safe duration of administration     may also offer cost savings.   "
65517|NCT02428101|"     This study will examine DNA from Gastrointestinal Tract of cancer patients treated with     oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to     drug-induced peripheral neuropathy in certain patients.      The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2     gene(G34A ,C421A genotypes) and correlated with peripheral neuropathy grades.   "
65518|NCT02428088|"     This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with     ADHD.   "
65519|NCT02428075|"     Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and     middle-income countries; however responses to CVDs are inadequate particularly due to lack of     conclusive evidence on population based approach to hypertension control. This is a community     based cluster randomized trial involving family based health education through female     community health volunteers in Nepal. People ≥25 years of age and who are listed in the voter     list 2006 of Electoral Commission of Nepal who were either hypertensive, pre-hypertensive or     normotensive are eligible for eligible for participation in the study. A computer generated     random codes will be used to divide clusters into treatment and control arm. FCHVs will     conduct family based health education and blood pressure measurements in the treatment arm vs     not any interventions in control arm. Independent assessors will conduct the baseline and end     line assessment of the intervention. Intention to treat analysis and per protocol analysis     will be used in analysis to detect significant differences between treatment and control     group participants at baseline and follow up. Student t-tests for normally distributed     variables and chi-squared tests for categorical variables will be used. In the event that     randomization do not control for differences between the treatment and control groups on     baseline characteristics, the investigators will statistically control for those differences     in subsequent analysis of program effects. The final outcome will be modeled by using     multiple linear regressions analysis. The investigators hope that if the intervention     outcomes shows positive effects in treatment arm, this approach can be adopted into the     existing health care delivery system in Nepal. Assessing the FCHVs' ability may further     contribute to developing a policy that can be scaled-up to a national level. The lessons     learned from this project may also be replicated in rural areas and similar settings     elsewhere in the world.   "
65520|NCT02428062|"     BACKGROUND: Post-operative cognitive dysfunction (POCD) is a potentially irreversible loss of     brain functions observed in elderly patients after surgical operations under general     anaesthesia. POCD at 3 post-operative months is observed in up to 15% of patients aged 70     years and more, and the only recognized risk factor for this condition is increasing age.     Importantly, the incidence of POCD at 3 months has been associated to an increased disability     and mortality.      OBJECTIVES: The present study will evaluate in patients aged 75 years and older undergoing     general anaesthesia for non-cardiac surgery, whether an hemodynamic strategy, aiming at     maintaining intra-operative arterial blood pressure close to patient's preoperative blood     pressure, i.e., to avoid hypotensive episodes, reduces the incidence of POCD at three months.      METHODS: Around 1800 consecutive patients scheduled to undergo general anaesthesia for     elective non-cardiac surgery will be enrolled. Each patient's cognitive function will be     evaluated preoperatively and at 3 months and 1 year postoperatively, together with the     occurrence of hearing loss and vestibular function impairment. Furthermore, the incidence of     postoperative delirium and cardiovascular, respiratory and infectious complications will be     evaluated.      EXPECTED RESULTS: The primary outcome is a 25% relative reduction in the incidence of POCD at     3 postoperative months. Secondary outcomes are the reduction of POCD incidence at 1     postoperative year, a reduction in postoperative hearing loss and vestibular impairment at 3     months, a reduction in the incidence of delirium. Hospital length of stay and 90 day     mortality will also be assessed. This present study could have a high socio-economic impact,     reduce healthcare costs and patient morbidity and mortality with a simple not expensive     intraoperative intervention.   "
65521|NCT02428049|"     The investigators want to:        1. Assess whether curative radiotherapy for lung cancer leads to permanently reduced lung          function        2. To assess the predictive value of pulmonary function tests for the development of a          permanent reduction in lung function after curative radiotherapy        3. To assess the predictive value of genetic markers for permanently reduced lung function          after curative radiotherapy   "
65522|NCT02428036|"     The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated     mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of     solid tumors with superficial lesions.   "
65523|NCT02428023|"     Our purpose is to investigate whether thallasaemia trait offers protection against     cardiovascular events and whether this can be applied to specific characteristics of these     people ( better lipid profile , better blood pressure profile) as scientific literature     suggests.   "
65527|NCT02427971|"     The Aysis® Cs2 ventilator offers an automated control of end-tidal inhalation anesthetic     concentration, the EtControl® mode. A low Fresh Gas Flow (FGF) (0.5L/min) is kept during the     maintenance of the anesthesia, decreasing the expensive consumption of halogenated agents.      The Perseus® A 500 offers a VaporView® mode that gives the evolution of inspired (Fi) and     end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered fraction     (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it possible to     maintain a low FGF (0.5 L/min), provided the halogen Fd is set to maintain a steady Fe curve.      The goal of this work was to compare the maniability of the intraoperative administered     concentrations and the consumption of Desflurane between these 2 modalities of     administration.   "
65528|NCT02427958|"     The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the     treatment of Central Precocious Puberty (CPP).   "
65529|NCT02427945|"     The investigators are seeking to overcome the dual challenges of under-nutrition and diarrhea     using an existing safe water supply platform to deliver nutrition information to targeted     groups in Western Kenya. Using a randomized evaluation, investigators will determine the     impact on nutrition status and practices of delivering nutrition information. The evaluation     results will enable Evidence Action to make strategic decisions regarding the potential     scale-up of the combined program across Kenya.   "
65530|NCT02427932|"     This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women     to that of non-pregnant women; the placental transfer over time; and the subsequent     metabolism of the transferred drug(s) in the neonate.   "
65531|NCT02427919|"     Granulocyte Colony Stimulating Factor (G-CSF, filgrastim) is now widely used after     chemotherapy which complicates hematological toxicity involving neutropenia. As prolonged     neutropenia leads to neutropenic fever due to bacteremia or fungal infection, the use of     G-CSF prevents severe infectious complication in various cancer patients.      In acute myeloid leukemia (AML), leukemic blasts have been expected to have G-CSF receptor     which may be stimulated by G-CSF, and refractory patients were not treated with G-CSF in     salvage chemotherapy in Catholic blood and marrow transplantation (BMT) Center for a long     time. This strategy induced prolonged neutropenia and a lot of infectious complications some     of which led to deaths.      Although there are some data which remind us G-CSF may proliferate leukemic blasts, the     investigators also identified several reports which suggested that subgroup with G-CSF use     showed acceptable CR rate and improved survival outcomes compared to a subgroup without G-CSF     use.      Therefore investigators are now trying to identify the effects of G-CSF for refractory AML     patients in salvage chemotherapy setting regarding the duration of neutropenia and admission,     incidence of infectious complications and the duration of antibiotics application.     Furthermore, overall response rate (CR+CRi) after salvage chemotherapy and survival outcomes     will be calculated according to G-CSF use.      Also, investigators will detect G-CSF receptor using cluster of differentiation 114 (CD114),     and analyze the clinical outcomes according to the subgroups with or without using G-CSF     during neutropenic period.   "
65532|NCT02427906|"     The purpose of this study is to determine the effect of transjugular intrahepatic     portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic     patients.   "
65533|NCT02427893|"     This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib     (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF     V600E/K mutant melanoma.   "
65534|NCT02427880|"     The purpose of this study is to determine whether using furosemide following acetazolamide is     effective in treating refractory edema associated with nephrotic syndrome.   "
65540|NCT02427802|"     This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel     cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized     to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with     either (A) daily application of a gentamicin-sponge, (B) daily application of a     placebo-sponge or (C) no-sponge, in the ratio 2:1:1.      Patients will be treated for approximately 28 days and return to the clinic weekly for safety     and efficacy assessments. After completing treatment, patients will return to the clinic for     scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.   "
65578|NCT02427308|"     The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR)     2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar     2015-Mar 2024.      This study is a prospective observational study in which female patients undergoing Impavido     who become pregnant during treatment or within 5 months after completing treatment can     volunteer to provide information about their pregnancy and the outcome of the pregnancy.   "
65579|NCT02427295|"     Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated     surgery with or without long acting somatostatin analogues.   "
65580|NCT02427282|"     This study aimed to compare the effectiveness and efficiency of miniscrew-supported and     standard frog molar distalizing appliances.   "
65541|NCT02427789|"     Depression is a disorder that causes major harm to physical health and social life. It     induces isolation, reduced physical and work capacity and increasing the risk of death. In     contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive     functions, stimulation of brain plasticity and resilience, in addition to promoting     self-esteem and social interaction. The precise mechanisms by which exercise improves     symptoms of depression are not fully clear, but it is probably multifactorial. In this     project, the investigators aim to investigate variables that provide additional information     about biomarkers involved in the pathophysiology of depression and therapeutic response to     exercise. The investigators expect to find changes in biomarkers associated with potential     mechanisms of neuroprotection (cytokines, markers of oxidative stress, Brain-derived     neurotrophic factor (BDNF), cortisol) after exercise program and the role in the therapeutics     of depression. To evaluate functional assessment indices will be used ergospirometry, a test     that determines the respiratory, cardiovascular and metabolic activity. Overall, this project     will help to investigate alternative adjunctive treatments for depression and their     associated biomarkers with response.   "
68240|NCT02392546|"     This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic     constipation. The purpose of the study is to compare the effects of daily single-dose oral     elobixibat and placebo for 7 days on colonic motor effects.   "
65535|NCT02427867|"     Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in     cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.      Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote     organ or vascular territory provides protection from injury by myocardial ischemia and     reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the     first proof of principle and small randomized controlled trials have shown a decreased     release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary     artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into     better survival in a recent randomized trial performed in cardiac surgery. No clinical trial     on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.      The investigators study wants to test, for the first time, the hypothesis that remote     ischaemic preconditioning is effective in reducing cardiac damage in high risk patients     undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by     inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5     minutes reperfusion while the cuff will be deflated. Cardiac troponin will be used as marker     of cardiac damage. If the results of a reduction in postoperative cardiac troponin release     and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery     setting, the investigators could improve a strategy to prevent perioperative cardiac     complication easy to apply, safe and low cost.   "
65536|NCT02427854|"     In this study the investigators want to assess complications associated to pregnancy and     delivery, and interventions used during labor.      Pregnancy and delivery related complications are a major health problem globally. Events     during labor such as excessive bleeding, uterine rupture, emergency cesarean delivery; other     instrumental deliveries and anesthesia problems are situations that potentially may lead to     severe outcomes for the mother and child.      Diabetes, anemia and hypertensive disorders may also complicate both the pregnancy and     delivery.      Between 60-80% of women delivering their first baby need suturing due to perineal tears     (tears located to the area between the vagina and anus). Superficial perineal tears rarely     cause long-term problems, but often lead to pain and discomfort immediately after birth.     Deeper or severe perineal tears, involving the anal sphincter, may influence the woman's     quality of life. This is mainly due to long-lasting pain, discomfort and sexual dysfunction,     and the fact that obstetric anal sphincter tear is the main cause of anal incontinence.     Recent clinical intervention studies have shown that the incidence of severe obstetric     perineal tears may be reduced by 50-70% by introducing a bimanual support technique of the     perineum. In these studies all midwives and gynecologists were trained in the bimanual     support technique. When it comes to training in new medical techniques in general, some     studies have shown that use of animated instructions on mobile phones may be a good     alternative to the more traditional hands-on or bedside teaching methods. In a global     perspective, it is important to study the efficacy of mobile units for transferring of new     knowledge, especially for use in resource constrained settings.   "
65537|NCT02427841|"     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation     and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating     patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy,     such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Radiation therapy uses     high-energy x-rays to kill tumor cells and shrink tumors. Giving paclitaxel     albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and radiation therapy     before surgery may make the tumor smaller and reduce the amount of normal tissue that needs     to be removed.   "
65538|NCT02427828|"     Failure to recognise deterioration early is a major cause of preventable deaths amongst     hospital patients. The investigators wish to study whether continuous monitoring of 'vital     signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled     alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care     readmissions from the wards by alerting staff to clinical deteriorations more effectively     than current paperbased systems.      Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of     'vital signs' has traditionally been restricted to the bedside because of the need for the     patient to be connected by wires to the monitor.      More recently, advances in telemetry (wireless technology) have allowed the development of     wearable devices which allow patients to mobilise freely, whilst constantly monitoring these     'vital signs'.   "
65539|NCT02427815|"     Reducing sleep health disparities was recognized as a priority area for intervention by the     National Institutes of Health. Sleep apnea, which disproportionately affects minorities, is     an important preventable and treatable disease that should be targeted as it is associated     with increased cardiovascular risk and disease outcomes, including obesity, diabetes,     hypertension, stroke, cardiac arrhythmia, and chronic heart failure. Evidence from previous     research suggests that most minorities are unaware of general sleep problems, such as sleep     apnea symptoms and the negative effects on cardiovascular disease. Only 26% of minorities     participating in the investigators prior research followed up on recommended sleep apnea     screening, although 39% were at high risk for sleep apnea. While few followed the physician's     recommendations, 90% of those assessed received a sleep apnea diagnosis. The investigators     research will assess the effectiveness of peer-based sleep health education and social     support in increasing sleep apnea screening and treatment rates among minorities with sleep     apnea risk. Participants will receive quality-controlled and culturally tailored peer     education using a sleep health education manual. They will each receive up to 4 sessions     promoting sleep apnea screening during a 6-month period. Those with a diagnosis will receive     2 additional sessions promoting sleep apnea treatment adherence, in conjunction with     telephone interventions. The investigators research will also assess the rate of sleep apnea     among minorities using home recordings. The long-term goal of the investigators study is to     apply this intervention in community-based settings (barbershops, beauty salons, churches,     and health centers), thereby linking community health promotion to the healthcare system.   "
66681|NCT02412917|"     This is a multicenter, randomized, double-blind, parallel-group, active controlled     comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus     valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).   "
65543|NCT02427763|"     Thermoplastic devices are used in orthodontic treatment and consists of a series of nearly     invisible, removable aligners. However, every device used in the mouth can change the buccal     flora and increase the number of bacterias. This is a risk factor for enamel     demineralization. The treatment can vary in time of use per day. The patient under     orthodontic treatment has to use the device for 22 hour each day. When the period of     retention comes, it is reduced to 8 hours. The investigators want to know if the     concentration of bacterias in saliva and dental plaque will increase, and if the material can     cause damage on gingiva.   "
65544|NCT02427750|"     The present study is designed to evaluate the safety and immunogenicity of trivalent, surface     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.      For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will     be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at     approximately 21 days post vaccination.      The vaccine composition will be based on the WHO recommended influenza strains for the 2015     Southern Hemisphere vaccine, and the data from this study are intended to support the use of     this vaccine in future influenza seasons if the recommended vaccine composition remains the     same.   "
65545|NCT02427737|"     Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of     claustrophobia or inability to hold still. Training staffs working in MRI facilities to     provide Comfort Talk® will enable patients to complete high quality imaging without     medication, which will increase satisfaction and comfort while reducing sedation risks for     patients, and increase efficiency and reduce loss of revenue for facilities. The effect of     such training will be tested at 12 MRI sites in a randomized design. Outcome data will be     collected for one year.   "
65546|NCT02427724|"     This study will conduct a split-face and -body randomized control trial to compare lidocaine     2.5%/prilocaine 2.5% topical anesthetic (LPTA), lidocaine 7%/tetracaine 7% topical anesthetic     (LTTA), and placebo vechicle (PV) on patients' pain perceptions with Q-switched 532nm laser     for the treatment of lentigines and/or photorejuvenation.Subjects will fill out a pain score     on a visual analog scale (VAS) with 0 being no pain and 10 being most pain after each     treatment area is completed.   "
65547|NCT02427711|"     To investigate if the use of a bipolar sealer for skin and capsula incision results in     decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.   "
65548|NCT02427698|"     This is a prospective randomized controlled study comparing the efficacy of cryolipolysis     versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite.     The treatment sites are both outer thighs. One outer thigh will be randomized to receive one     treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the     combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist     will evaluate the treatment and control areas using a cellulite severity scale at week 0     (before treatment) and at the 3-month follow up visit.   "
65549|NCT02427685|"     The study verifies accuracy of a new pulse co-oximeter in the presence of elevated     carboxyhemoglobin levels.   "
65550|NCT02427672|"     This study investigates the effect of upregulating prefrontal cortex activity on antisocial     and aggressive behavior and risk factors for such behavior. In the double-blind, randomized     controlled trial, participants will undergo anodal transcranial direct current stimulation     bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after     stimulation, they will complete survey and laboratory measures assessing antisocial and     aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and     skin conductance will also be measured.   "
65552|NCT02427646|"     The present study attempts to fill a critical knowledge gap of BoNT A in tremor management by     studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in essential     tremor and idiopathic Parkinson disease using data regarding composition of tremor obtained     through sophisticated, yet clinically accessible multi-sensor based kinematic information.   "
65573|NCT02427373|"     A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in     which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d     eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish     oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to     compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at     the end of the 4 week study.   "
65574|NCT02427360|"     This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with     uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum     species). The review of patients' records and blood samples will be performed for patients     treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to     December 2013.   "
65553|NCT02427633|"     In resource limited settings, access to one-on-one nursing care and airway protection by     intubation may be unavailable. Patients with coma but adequate oxygenation are frequently     cared for on medical wards, and nursed by their family members. The investigators previously     audited the use of the recovery position in patients with cerebral malaria and found that its     usage was greatly increased by an educational intervention aimed at patient's caregivers. A     trend to reduction in coma duration and aspiration pneumonia was also found. Since there is     no evidence that placing comatose, non-intubated patients in a recovery position improves     outcome, the investigators plan to conduct a randomised controlled study comparing standard     care with an educational intervention targeting patients' relatives, teaching them to     maintain their relative in one of two different recovery positions. With the preliminary     efficacy and safety data and feedback that this study will provide, the investigators would     then move to conduct a large multicenter study powered to detect a difference in mortality.   "
65554|NCT02427620|"     The goal of this clinical research study is to learn if a combination of ibrutinib and     rituximab plus the combination of 2 different intensive chemotherapy regimens can help to     control MCL. The safety of this drug combination will also be studied.   "
65555|NCT02427607|"     To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in     participants with epilepsy. This study will be continued until perampanel is commercially     available.   "
99898|NCT01978548|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).   "
65557|NCT02427581|"     The most important consideration in the design of this clinical trial is to ensure the safe     translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug     Administration (FDA) dictates that initial studies of biologic therapies be performed in such     a way that there is a balance between the potential risks and benefits in individual     patients. Consistent with these recommendations, the investigators will target patients with     triple-negative breast cancer who do not have a pathologic complete response after     neoadjuvant chemotherapy. These patients typically have no gross evidence of disease     following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy)     but are at extremely high-risk for disease recurrence. Targeting this patient population     provides a window-of-opportunity to design and manufacture the personalized cancer vaccines,     maximizes the potential benefit from the vaccine as the regulatory networks associated with     metastatic disease are not present, and balances risk in this patient population with     extremely high risk for disease recurrence but no other treatment options.   "
65558|NCT02427568|"     This small study is designed to provide information on whether MDMA-assisted psychotherapy is     safe and helpful for people with anxiety related to a life-threatening cancer or neurological     illness. The research is to see if psychotherapy combined with MDMA in a therapeutic setting     can ease anxiety in the face of a life threatening illness. Once enrolled in the study,     people will either receive two day-long psychotherapy sessions with MDMA or placebo, with     five people getting placebo and 13 getting MDMA. Anxiety, depression, sleep quality,     attitudes toward death, posttraumatic growth, mindfulness, self-compassion, and overall     quality of life will be measured at the start of the study and after these two sessions.     People close to the participant will also complete questionnaires about the participant     during the study on their mood and behavior. Participants who received placebo can enroll in     Stage 2, during which they will receive three psychotherapy sessions with MDMA, and     participants who received MDMA will have a third MDMA-assisted experimental session. Anxiety     and other symptoms will be measured again six and 12 months after each participant's final     experimental session.   "
65559|NCT02427555|"     The main objective is to investigate gut microflora composition in relation to     cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a     barley kernel based product on these variables.   "
65560|NCT02427542|"     This is a feasibility trial designed to test the feasibility and acceptability of a brief     form (six sessions) of Cognitive Behavioural Therapy (CBT) for     Depersonalisation/Derealisation (DP/DR) in those individuals who also have a diagnosis of a     psychotic disorder. Participants will be randomised to receive either six sessions of CBT     targeting DP/DR symptoms or to a treatment as usual control condition.   "
65561|NCT02427529|"     Subjects are female patients, randomized to HCG group or placebo group, during a prospective     trial, in order to determine the significance, if any, of HCG on maintaining muscle mass     during a very low calorie diet in order to demonstrate the potential significance of HCG     administration on preserving lean body mass while losing weight.   "
65562|NCT02427516|"     To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations,     consultations, medications, and tests) of adequately controlling a patient (i.e. INR between     2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous     thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.   "
65575|NCT02427347|"     To evaluate the effectiveness of acupuncture therapy combined with healthy education for     patients with abdominal obesity.   "
65576|NCT02427334|"     Two hundreds and ten women with premenstrual syndrome will be randomly divided into 3 equal     groups using computer generated random numbers. Group 1 will receive oral dienogest (visanne®     Bayer, Germany) 2mg for 14 days starting from the 15th day of menstruation, Group 2 will     receive fluoxetine (Prozac® Lilly, UK) 20mg and group 3 will receive an oral placebo foe 14     days starting from the 15th day of menstruation.   "
65577|NCT02427321|"     This study will collect video recordings of routine flexible cystoscopy examinations, medical     history and diagnosis information, from up to 100 participants who have a history of bladder     cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system     for recording and reviewing images of the bladder, and to assess the utility of this system.   "
65563|NCT02427503|"     Inflammation of the nasal and bronchial mucosa characterizing rhinitis and asthma are     probably manifestations of the same disease. Multiple functional observations, pathogenic and     clinical support that assertion. It is noteworthy that most asthma patients, who underwent a     nasal endoscopic polypectomy, improve your asthma after surgery. This improvement would be     related to the administration of oral steroids that these patients usually receive after     surgery, or the disappearance of nasal discomfort caused by nasal polyps to improve     ventilation. But this does not explain why this improvement, in some cases lasting for months     after the operation, and without receiving oral steroids. It is speculated that severe nasal     inflammation due to nasal polyps stimulate the bone marrow to produce more eosinophils, an     increased supply of blood eosinophils, and consequently, a major bronchial eosinophilic     inflammation, aggravating asthma. However, it is noteworthy that studies have evaluated the     clinical impact in asthma after endoscopic nasal polypectomy, are scarce or performed on a     small number of cases, the results are inconsistent and do not allow categorically whether or     not such positive association. And more importantly, none of them included measurements of     airway inflammation and hypothesized relationship between bronchial eosinophilic inflammation     and nasal polyposis, aclarar.La remains finding that provides nasal endoscopic polypectomy     objective improvement of severe asthma it could be a future therapeutic option to consider in     patients with asthma and rhinosinusal polyposis.   "
65564|NCT02427490|"     In congruence with the National Cancer Institute's commitment to supporting families of     individuals with cancer across the full disease trajectory, the investigators seek to examine     the feasibility of a technologically-mediated problem-solving intervention designed to     improve the quality of life and decrease the psychological distress of family caregivers of     cancer patients receiving outpatient palliative care. Investigators involved in this mixed     methods pilot study will collect and analyze both quantitative and qualitative data, which     will subsequently inform a large-scale randomized clinical trial of the problem-solving     intervention.   "
65565|NCT02427477|"     Approximately 120 subjects will be comparing two soft contact lenses for one week each.   "
65567|NCT02427451|"     This phase Ib/II trial studies the best dose and safety of Bcl-2 inhibitor GDC-0199 in     combination with obinutuzumab and ibrutinib and to see how well they work in treating     patients with chronic lymphocytic leukemia that has returned (relapsed), does not respond to     treatment (refractory), or is previously untreated. Bcl-2 inhibitor GDC-0199 and ibrutinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as obinutuzumab, may block cancer growth in different ways by     targeting certain cells. Giving Bcl-2 inhibitor GDC-0199 together with obinutuzumab and     ibrutinib may be a better treatment for chronic lymphocytic leukemia.   "
65568|NCT02427438|"     The primary purpose of this study is to assess the effect size of the change in Oswestry     Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video based     instruction or standard of care hand-out with pictures and written instructions for subjects     meeting the clinical prediction rule for lumbar stabilization.      The second purpose will be to determine if there is a subset of physical examination and     self-reported variables that are associated with having a successful result (ODQ improvement     by at least 6 points) and if the subset of variables are affected by whether or not the     subject was in the intervention (video) or control (handout) group.   "
65569|NCT02427425|"     Introduction: Low back pain is one of the most common complaints in doctors' offices, and     acute low back pain is characterized by episodes of pain with less than three weeks duration.     The transcutaneous electrical nerve stimulation (TENS), based on the gate control theory of     pain proposed by Melzack and Wall in 1965, has been used as an adjunctive therapy in the     control of back pain, being a non-invasive, low cost, safe and easy to apply. No studies were     found regarding the effectiveness of TENS in acute low back pain.      Objective: To evaluate the effectiveness of TENS in pain management of patients with acute     low back pain.      Material and Methods: A randomized clinical trial, double-blinded and placebo-controlled.     Patients were selected in the clinics of Federal de University of Sao Paulo (UNIFESP)     according to the following criteria: acute low back pain, both genders, aged between 18 and     65 years, pain between 4 and 8cm in pain numeric scale (PNS) and who agreed to participate in     the study. After signing the informed consent patients were randomly allocated into one of     the groups: TENS group (TG) or Placebo Group (PG). In TG was applied conventional TENS with     frequency and intensity variation (FIV) effect, frequency of 100 hertz, a pulse width of 60μs     and intensity adjusted according to the individual baseline for each patient without causing     muscular contraction. The electrodes were arranged in a cross shape in the paravertebral     region (levels T12-L1 and L5 - S1). In PG the same procedures were adopted, but did not occur     electrical stimulus. Patients were informed that they could or could not feel electric     shocks. Treatment consisted of 10 sessions (2x / week / 5 weeks), with each session lasting     30 '. Assessments were made at the following times: T0 (baseline), T1 to T10 (the beginning     and end of each session), T11 (after the last session), T30 (30 days after the last session)     and T60 (60 days after the last session). Assessment tools: PNS for pain, short-form 36     (SF-36), Roland-Morris, self-assessment of improvement (Likert scale) and drug consumption     (daily).   "
65570|NCT02427412|"     A randomized, prospective, placebo-controlled study which aims to evaluate the effect of     combined intraarticular and intravenous Tranexamic acid on total blood loss following     unilateral knee replacement versus only intravenous tranexamic acid.   "
65571|NCT02427399|"     The purpose of this project is to determine whether outreach to HIV-negative patients who are     overdue for a Pap smear at a New England urban community health center can increase cervical     cancer screening rates. It additionally seeks to determine which form of outreach - via     letter, email, phone, or a mixture of those modalities- is most effective among these     patients.   "
65572|NCT02427386|"     Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat.     In view of this, many patients seek assistance in complementary and alternative medicine,     including homeopathic treatment. The absence of evidence in the literature raises controversy     about the effectiveness of homeopathic treatment in endometriosis. The aim of this randomized     trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the     treatment of chronic pelvic pain of endometriosis.   "
66757|NCT02411929|"     This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of     ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and     intravenous (IV) and oral administration of 14^C-labeled ertugliflozin in healthy male     participants.   "
65581|NCT02427269|"     Aim 1: To develop a prospective tissue and blood biorepository from patients with a history     of Barrett's Esophagus (BE) or esophageal cancer (ECA) presenting to UNC hospitals for     routine care upper endoscopy for their condition.      Aim 2: To collect clinical data from patients with a history of Barrett's Esophagus (BE) or     esophageal cancer (ECA) that includes demographic data, endoscopic procedure data, and     pathology data.      Aim 3: To integrate Aim 1 and 2 in a manner that will provide an efficient bi-directional     flow of clinical information and specimens between laboratory and clinical scientists in     order to foster innovative translational research.      Aim 4: To create a biorepository for future IRB approved studies that have a tissue and/or     blood specimen component.   "
65582|NCT02427256|"     The primary objective of this clinical study is to collect additional clinical data to     support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary     objective is to evaluate any adverse events found during the clinical study.   "
65583|NCT02427243|"     To assess the relative bioavailability and tolerability of two different formulations of     crenezumab in approximately 60 healthy volunteers.   "
65584|NCT02427230|"     The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and     intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary     incontinence and improving quality of life in women with spinal cord injury (SCI).   "
65585|NCT02427217|"     This is a multicenter, non interventional, retrospective cohort study with a prospective,     observational follow-up component to investigate the safety and efficacy of FCH use in     subjects with congenital fibrinogen deficiency. Data will be collected on the safety and     efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and     perioperative bleeding in these subjects. All subjects have received FCH and may continue to     receive FCH at the discretion of the treating physician / Primary Investigator according to     the standard of care at the participating study site.   "
65621|NCT02426749|"     This proposal aims to investigate the effect of a promising treatment for persistent post     Traumatic Brain Injury (TBI) symptoms, and to monitor TBI patient's recovery by an objective     technique along with standard clinical assessments. The treatment tool is the application of     repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex     (DLPFC) of the brain. The treatment efficacy and monitoring TBI patients' recovery will be     objectively assessed using Electrovestibulography (EVestGTM); this will be in parallel with     clinical and standard assessments.   "
65586|NCT02427204|"     The main questions being addressed are (1) how patient reported outcomes change during     treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how     much treatment costs from the payer's perspective and the patient's perspective. The     hypothesis being tested is that treatment has a negative effect on the quality of life during     treatment. The negative effect is expected to be temporary. Successful treatment, which is     equated with a virological cure of the infection, is expected to result in an improvement in     quality of life compared to baseline and to improvement in markers of liver function and     liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.   "
65587|NCT02427191|"     Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as     compared to the saline placebo injection in the treatment of plantar fasciitis   "
65588|NCT02427178|"     The purpose of this study is to find out if a stem cell transplant is safe for patients with     a very rare disease. The stem cell transplant is called AHSCT (for allogeneic hematopoetic     stem cell transplantation). The rare disease is called MNGIE (for Mitochondrial     NeuroGastroIntestinal Encephalomyopathy). Patients with MNGIE will be transplanted with stem     cells from an individual who is human leukocyte antigen (HLA) 10/10 matched. The purpose of     the transplant is the production of thymidine phosphorylase.   "
65589|NCT02427165|"     The number of people with of asthma and allergy is still increasing and a large number of     patients still do not have their asthma well controlled. There is therefore a need for new     asthma treatments that work well and have less side effects. The study compares a new     experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.   "
65590|NCT02427152|"     Obesity is considered to be caused by an imbalance between energy expenditure and energy     intake. A major determinant of our daily energy intake is the size of the meals that we     consume. It has been suggested that decisions about portion sizes are often made in advance,     before a meal begins. This pre-meal planning is considered to especially depend on the     estimated 'expected satiety' and 'expected satiation' of different foods. Further, also     factors like weight concern and palatability of the food might have their influence on meal     size selection. In general, it is not clear how these factors are integrated during pre-meal     planning and which brain networks are involved in these decisions/this process. Thus, the     investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese     individuals with functional magnetic resonance imaging under different cognitive instructions     including pleasure, expected satiety and self-control in terms of health consequences. The     investigators will explore the neural networks involved in pre-meal planning and expect them     to be modulated by the before mentioned factors. Further, the investigators plan to explore     gender differences and expect that female subjects will select smaller portion sizes     especially in the self-control condition as they are often more concerned about their     weight/health. Finally, the investigators will explore differences between lean and     overweight subjects to elucidate factors that might lead to increased meal sizes in     overweight subjects.   "
65591|NCT02427139|"     The specific aim of the study is to do comparison between ANSiStim and Placebo for pain     relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active     labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative     patients with good pain relief .   "
65592|NCT02427126|"     Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active     controlled, efficacy study (phase III)   "
65593|NCT02427113|"     The purpose of the study will be to examine the effectiveness of an innovative use of music     on TMD. Music and rhythmic vibrations can alter the basic processes related to sensation of     pain in the brain. As well, music can block the neurological pathways that transmit pain     sensations and thereby reduce pain. Music and vibrations are relaxing, reduce stress, and     thereby reduce sensitivity to pain.   "
65616|NCT02426814|"     The purpose of this study is to assess the use of a mobile health intervention to improve     adherence to asthma medication among adolescents. The intervention consists of an inhaler     sensor strap to monitor asthma inhaler use and a mobile phone application to remind and     incentivize patients to use their medication. This study will assess medication use     throughout a 12 week study in patients who receive a mobile app with reminders, asthma     control as measured by the ACT [asthma control test], and lung function as measured by     spirometry.   "
65594|NCT02427100|"     The proposed study will utilize a randomized controlled trial design to pilot-test a 4-week     shelter-based diet and physical activity intervention in a sample of homeless adults residing     in the transitional shelter at The Bridge Homeless Assistance Center in Dallas, TX (N = 50).     Participants will be randomly assigned to a diet/physical activity intervention group (n =     25) or a paid assessment-only control group (n = 25). Three intervention strategies will be     employed: 1) computer-tailored newsletters adapted from a program supported for use in other     populations, 2) the distribution of fruit and vegetable snacks directly to individuals, and     3) the provision of pedometers and walking goals. Thus, the primary aim of the proposed study     is to 1) evaluate the feasibility and effectiveness (relative to an assessment-only control     group) of a shelter-based intervention designed to improve dietary intake and increase     physical activity among homeless individuals. The main study outcomes will be average daily     fruit and vegetable consumption and objective pedometer/ accelerometer assessment of physical     activity (assessed weekly) over the 4-week study period, and at a follow-up assessment 4     weeks after the conclusion of the intervention. Secondary aims will focus on: 2) identifying     intervention-related differences (relative to the control group) in indicators of physical     health including blood pressure, weight, body mass index (BMI), waist circumference, and     other dietary variables (i.e., caloric intake, meals consumed outside of the shelter, daily     fat and fiber intake) and 3) identifying psychosocial variables associated with dietary     quality and physical activity.   "
65605|NCT02426957|"     The study will use a two group randomized controlled trial to compare a brief motivational     interviewing (MI) intervention to TAU with 50 adolescents psychiatrically hospitalized for a     suicide plan or attempt who have co-occurring alcohol use. Data will be collected via     in-person interviews and self-administered questionnaires at baseline and 3 month follow-up     assessments to explore outcome changes in negative alcohol expectancies, confidence in     ability to handle situations where alcohol is present, likelihood of receiving alcohol     treatment, frequency of alcohol use, and suicidal ideation, suicide planning, and suicide     attempts for adolescents receiving the intervention relative to TAU.   "
65595|NCT02427087|"     Were included 40 patients with NAFLD followed at the Ambulatory of Non-alcoholic Fatty Liver     Disease , Discipline of Clinical Gastroenterology, Clinic Hospital of the Medical School of     the University of Sao Paulo (HC-FMUSP). Were included adults women of any race, aged 35 to 75     years, diagnosed with NAFLD and were followed for a period of six months. All patients     underwent anthropometric and body composition, as well as analysis of clinical, laboratory     before and after 6 months of exercise training protocol established.      The hypothesis of our research is that aerobic activity had a favorable impact on NAFLD. It     is expected that the intervention of physical activity causes a decrease or no weight,     decreased levels of aminotransferases, decreased insulin resistance assessed by homeostasis     model assessment (HOMA) index and consequently decrease or reversal of hepatic steatosis.   "
65596|NCT02427074|"     Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are     analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and     salivatory functions are analysed as well.   "
65597|NCT02427061|"     Sexual violence (SV) and adolescent relationship abuse (ARA) are prevalent among adolescents     and associated with poor health. Global health organizations highlight engaging men and boys     in preventing violence against women as a potentially impactful public health strategy. This     study aims to test, via a two arm cluster randomized controlled trial, a gender     transformative SV/ARA perpetration prevention program among African American adolescent     males ages 13-19 (target is high school age) implemented in a community-based setting.     Gender transformative refers to a theory- and evidence-based approach to alter gender norms     that foster SV/ARA while promoting bystander intervention (i.e., giving boys skills to     interrupt abusive behaviors they witness among peers) to reduce SV/ARA perpetration. As the     acceptance of SV and involvement in unhealthy sexual behaviors are associated with SV/ARA     perpetration, this program integrates analysis of social norms that condone violence against     women, sexual health promotion, and skills in bystander intervention -- an approach that has     been implemented in multiple non-U.S. settings among young adult males with reductions in     violence, development of more equitable gender attitudes, and less risky sexual behaviors.     This will be the first test of such a gender transformative program among adolescent males in     the U.S. Via a 2-arm cluster-randomized trial in youth-serving agencies (16 clusters, N=840     adolescent males ages 14-19), this study will assess the effectiveness of Manhood 2.0     (proposed name for this gender transformative program) compared to a job skills curriculum.     Three months after the end of the program (Time 2), compared to controls, youth will     demonstrate increased positive bystander intervention behaviors (secondary outcome).     Intermediate outcomes are: condom use self-efficacy; contraception use attitudes; recognition     of abusive behaviors; gender-equitable attitudes; and intentions to intervene with peers.     Nine months after intervention completion (Time 3), youth will report less perpetration of SV     and ARA toward females (Primary Outcome) compared to controls. This study will provide     urgently needed information about the effectiveness of a gender transformative program that     combines healthy sexuality skills, gender norms change, and bystander skills to interrupt     peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent     males.   "
65598|NCT02427048|"     This study will develop and test an intervention given to emergency medicine providers to     improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis.   "
65599|NCT02427035|"     This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose     study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult     subjects with moderate renal impairment and in healthy adult subjects with normal renal     function.   "
65600|NCT02427022|"     Clinical social workers and other staff providing direct care to individuals experiencing     homelessness face multiple challenges in obtaining training and implementing evidence-based     practices in diverse community settings. Critical Time Intervention (CTI) is an increasingly     popular evidence based practice with these agencies.      With funding from a Phase II Small Business Innovation Research grant from the National     Institute of Mental Health, the Center for Social Innovation developed an online multi-media     training on CTI which incorporates a Community of Practice approach to encourage peer-based     learning.      The primary aim of this longitudinal, randomized-control study is to compare and contrast     this online training modality with a face-to-face training on implementation of and fidelity     to the CTI model over time. Nearly two-hundred direct service providers from 20     homeless-service agencies were randomly assigned to complete either an online or face-to-face     training in CTI. Pre-post training and knowledge-retention surveys, interviews with trainers,     agency administrators, and providers were conducted to track satisfaction with the training     and experiences in implementing CTI. CTI-specific chart forms are used to assess fidelity to     the CTI model, and administrative data from the agencies capture client-level outcomes.   "
65601|NCT02427009|"     The main objective of this study is to assess the rate of recurrence of headache following a     first blood patch where patients will be positioned in the prone position for an hour after     each blood patch needed during this study.   "
65602|NCT02426996|"     The main objective of this study is to evaluate, after surgery for chronic anterior shoulder     instability using a Latarjet technique with positioning of the bone block via an SEM     positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery     in the decision to return to activity early as conditioned by the quality of the bone block     consolidation.   "
65617|NCT02426801|"     The purpose of this study is to assess the feasibility of using a mobile health intervention     to improve adherence to asthma medication among adolescents in an urban clinic setting. The     intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile     phone application to remind and incentivize patients to use their medication. This study will     assess the feasibility and acceptability of this intervention to patients.   "
65603|NCT02426983|"     Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation     which uses a very weak constant current to temporarily excite the brain area of interest via     small electrodes placed on the scalp. Currently, tDCS is being used as a tool to investigate     mental processes (cognition) and motor function (movement) in healthy controls and to treat     neurological (i.e. stroke) and psychiatric (i.e. depression and dementia) patients. tDCS has     been found to improve motor processes and cognitive performance, including attention and     memory functions. This study will attempt to examine the effects of tDCS on a specific aspect     of short term memory to sounds measured from electrical activity (EEG) from the top of the     scalp. This study will also assess the effect of a drug, dextromethorphan (DMO), commonly     found in cough syrup, which is thought to regulate tDCS treatment through brain receptors.     The study involves four laboratory test sessions. EEG assessments will be done in two     sessions involving 'anodal' tDCS stimulation (to temporarily excite cortical activity     locally), one session with DMO treatment and one with placebo treatment, and two sessions     involving 'sham' tDCS stimulation (device is turned off), with the same DMO and placebo     treatments. These findings will contribute to our understanding of the brain chemistry     involved in tDCS treatment and its effects on cognitive abilities.   "
65604|NCT02426970|"     The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II     questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability     Index, ODI) at 6 months.   "
65606|NCT02426944|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%.     Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The     source of a cardioembolic event is a thrombus, which usually forms in the left atrial     appendage (LAA). The prevention of cardioembolic events involves treatment with anticoagulant     drugs, which were limited to, until recently, vitamin K antagonists (e.g. warfarin).     Anticoagulant treatment with warfarin can lead to adverse bleeding events, some of which can     be life threatening. Recently, two new options for thrombus prevention have been developed.     The first is the novel anticoagulants (NOAC), which were associated with slightly better     safety profiles due to a lower frequency of intracranial bleeding in large randomized trials     . The second option involves interventional occlusion of the LAA. The aim of this project is     to compare the LAA occlusion intervention to NOAC pharmacological treatment in a randomized     multicenter study of AF patients at high risk of a cardioembolic event.   "
65607|NCT02426931|"     This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid     ureterorenoscope for the treatment of renal calculi using a prospective, randomized     multicentre trial design. Half of participants will receive retrograde intrarenal surgery     using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will     receive retrograde intrarenal surgery using the classic flexible ureteroscope.   "
65608|NCT02426918|"     The primary objective of this study is to evaluate the efficacy of 2 different doses of     intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in     the treatment of patients with staphylococcal ABSSSI.   "
65609|NCT02426905|"     A study to review Wilson disease patients who have previously been prescribed d-     Penicillamine but were changed to trientine as treatment for their disease, and to follow     them for a further 12 months.   "
65610|NCT02426892|"     The goal of this clinical research study is to learn if nivolumab combined with ISA101 can     help to control cancer that has spread. The safety of the study drugs will also be studied.   "
65611|NCT02426879|"     There is no world-wide consensus on the oncological benefit versus increased morbidity     associated with three field lymphadenectomy in patients with esophageal cancer and cervical     lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three     field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes.     However, in Western countries patients with cervical lymph node metastases are generally     precluded from curative treatment.   "
65612|NCT02426866|"     The purpose of this study is to determine whether there is an increased risk of     cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in     patients with HIV.   "
65613|NCT02426853|"     The goal of this research study is to learn how students react to seeing a photograph of any     skin damage they may have on their face. This skin damage may be caused by sun exposure or     use of tanning beds. Researchers also want to learn about students' sun protection, tanning     behaviors, and attitudes towards sun exposure, sun protection, tanning behaviors and skin     cancer.      Researchers will use the results of this study to design programs for students about sun     protection and tanning avoidance.   "
65614|NCT02426840|"     Since there is no cure for HIV, therefore antiretroviral therapy must be taken life-long.     Some of the HIV medications can negatively impact the health of the bone and is even more     exacerbated in perinatally HIV-injected children and adolescents because this is the period     when the bone peaks. Bone loss during this period can be devastating and increase the risk     for developing weak bones later in life. Supplementation of calcium and vitamin D have not     been well studied in HIV-infected children and adolescents in developing countries. Therefore     it is not clear whether higher doses of these supplementations can thwart the damages or not.   "
65615|NCT02426827|"     The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS)     for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence     of cerebral vasospasm.   "
65661|NCT02426229|"     This study evaluates if dabigatran etexilate is safe for use in patients with Scleroderma and     Interstitial Lung Disease. All patients will receive 75mg of dabigatran etexilate twice a day     for 6 months.   "
65618|NCT02426788|"     Brief Summary: Persistent Physical Symptoms (PPS; also known as medically unexplained     symptoms - MUS) is a term used to describe a range of physical health difficulties that     people can experience and for which the exact cause is unclear. Between 20 and 40% of     patients in primary care, and about 50% in secondary care experience PPS. Not only are PPS     common, but the overlap across different patient groups may indicate that these phenomena are     transdiagnostic. PPS are associated with profound disability and high health care costs, and     if left untreated the prognosis of these patients is poor. There is an accumulating body of     evidence demonstrating that cognitive behavioural interventions can reduce levels of symptoms     and improve functioning in patients with PPS. A pragmatic RCT was designed to evaluate the     clinical and cost-effectiveness of cognitive behavioural therapy (CBT) + Standard Medical     Care (SMC) versus Standard Medical Care alone, in the treatment of patients with PPS. The     trial will focus on patients with a variety of symptoms (e.g., non-cardiac chest pain,     fibromyalgia), across secondary care clinics (e.g., neurology, cardiology, and rheumatology).     Patients who have been referred to secondary care in the past six months will also be     recruited from General Practice (GP) surgeries.   "
65619|NCT02426775|"     A Phase IIIb (Three b), Randomized Multicentre Comparative Trial to Evaluate the Long Term     Effectiveness & Safety of the use of Carglumic Acid (Carbaglu®) in Patients with Propionic     Acidemia (PA) or Methylmalonic Acidemia (MMA). Carbaglu® clinical experience in Organic     Acidemia (OA) is limited to a non-comparative retrospective collection of data from patients     who had received Carbaglu® for 1 to 15 days.      There is no current evidence supporting the use of carglumic acid for the chronic management     of patients with OA. The investigators are proposing a randomized multicentre prospective     clinical trial to evaluate long-term effects of the use of Carbaglu® (50mg/kg/day) combined     with standard chronic therapy in patients with PA and MMA compared to standard chronic     therapy alone.   "
65620|NCT02426762|"     The purpose of this study is to evaluate the short-term effect of sealant-assisted skin     closure in prevention of surgical site infection after laparoscopic surgery.   "
65649|NCT02426385|"     The study is an observational non-randomised controlled study comparing the visual acuity     after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC   "
65622|NCT02426736|"     In this factorial design study, 280 participants having outpatient, arthroscopic shoulder     surgery will be randomized into 4 equal sized groups. All participants will receive a     standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the     intravenous or perineural (by the nerve with the nerve block) route just prior to their     surgery. The purpose of this study is to determine which dose and route of dexamethasone     provides the longest duration of pain control and the fewest side effects after surgery. The     investigators hypothesize that giving dexamethasone by the perineural route, and by higher     doses, will result in the longer durations of pain control, without increased side effects.   "
65623|NCT02426723|"     This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or     refractory MM:        -  Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the          maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review          Committee (SRC).        -  Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding          followed by cohort expansion at the combination therapy MTD or optimal dose as          determined by the SRC.   "
65624|NCT02426710|"     Background: Radiofrequency ablation of typical atrial flutter present the most effective     treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant     anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the     achievment of complete bidirectional block across the CTI is sometimes chalenging.     Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the     anatomy of the atria and also for the location of catheter position on CTI during ablation.     If the routine use of ICE is associated with easier atrial fluter ablation is not clear.      Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will     be enrolled into the study. The patients will be randomized into group (A) ablation with use     of ICE and (B) ablation without ICE. The ablation will be done in both groups by two     diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter     positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the     ablation is the achievment of the bicidrectional block across the CTI. The end-points of the     study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation     time. The safety end-point is clinically significant bleeding from the groin due to     additional puncture for ICE catheter.      Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery,     fluoroscopy time and the length of the procedure without increasing the bleeding.   "
65625|NCT02426697|"     The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the     prevention of pain induced by mobilization in patients receiving a bone metastasis radiation     for bone metastasis irradiations   "
65626|NCT02426684|"     IdeS® is an IgG-degrading enzyme of S.pyogenes that cleaves all four human subclasses of IgG     with strict specificity. Alloantibodies are a major deterrent to access to and success of     life-saving organ transplants. We hypothesize that the use of IdeS® pre-transplant in HS     patients will represent a more robust and complete technique to eliminate DSA from the sera     of HS patients. A single dose administration of IdeS® in the pre-operative period to HS     patients with positive DSAs and flow cytometry crossmatches will durably eliminate     circulating DSAs, allow transplantation to occur without ABMR and, in conjunction with     standard desensitization therapy, result in a durable suppression of DSA levels thus     eliminating the risk for ABMR.   "
65662|NCT02426216|"     This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably     alter biomarker expression, whether serum carotenoids levels are associated with biomarkers     levels, and whether the alterations of biomarker expression may reflect the cancer risk as     shown by cancer incidence at the end of the clinical trial.   "
65627|NCT02426671|"     The investigators propose that a novel experimental device 'MuteButton' can affect the     awareness of tinnitus. Sound that arrives at the ears naturally will be presented in the form     of touch patterns on the tongue. By learning to associate the sounds in the ears with the     sound patterns on the tongue, the investigators aim to demonstrate that the brain will learn     to discriminate the real sounds from legitimate external sounds from the imaginary tinnitus     sounds that are created inside the brain. Tinnitus is an audiological condition most commonly     described as 'ringing in the ears' that affects an estimated 40 million people globally     (American Tinnitus Association; Royal National Institute for Deaf). More accurately, tinnitus     is the perception of illusory sound that has no legitimate external source and normally     arises from a small number of underlying neuropathologies. There are broadly two categories     of tinnitus Somatic Tinnitus and Hearing Loss Related Tinnitus.      MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The     study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The     objective of the study will be to determine the impact of acoustic and tactile multi-modal     neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and     subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking     (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale     (VAS).   "
65628|NCT02426658|"     This pilot phase II trial studies how well pemetrexed disodium works in treating patients     with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG)     performance status of 3. Performance status means how well patients are able to perform daily     activities and care for themselves. Patients with a performance status of 3 have a limited     ability to move around. Currently, only patients who are able to perform most of their daily     activities may receive chemotherapy, due to the side effects it may cause. Pemetrexed     disodium causes fewer side effects than many chemotherapy drugs and may help treat patients     with stage IV non-small cell lung cancer and a lower performance status.   "
65650|NCT02426372|"     The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety,     tolerability, compliance, mechanism of action and efficacy of QBECO site specific     immunomodulation for the induction of clinical response and remission in subjects with     moderate to severe ulcerative colitis   "
65651|NCT02426359|"     This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to     evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to     severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for     8 consecutive weeks.   "
65629|NCT02426645|"     The aim of this study is to investigate associations between early structural cellular injury     and microvascular alteration with progression of septic organ dysfunction according to total     SOFA-Score (an ICU-scoring system - the Sequential Organ Failure Assessment Score). Patients     will be monitored for renal (TIMP-2, IGFBP7), and intestinal biomarkers (plasma i-FABP) in     conjunction with kidney and muscle vascular bed microvascular perfusion analysis assessed by     contrast-enhanced ultrasonography (CEUS). In parallel, a comprehensive analysis of patients'     immunological status will be conducted using an established, on-site immune monitoring panel.      The ultimate goal of this study is an early identification of septic patients developing     multiorgan dysfunction which may facilitate a timely novel intervention in the future to     improve outcome.   "
65630|NCT02426632|"     The primary objective is to evaluate in a double-blinded (neither physician nor participant     knows the treatment that the participant receives), fashion the taste of different     JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678,     10 milligram/milliliter oral solution without sweetener/flavor).   "
65631|NCT02426619|"     This randomized clinical trial aims to compare the effectiveness of three topical fluoride     application protocols, namely three applications of a 30% SDF solution at yearly or weekly     interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental     caries in the primary teeth of preschool children over 30 months.   "
65632|NCT02426606|"     The purpose of this study is to assess the effects of consuming various lentil varieties in     mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and     insulin as compared to white rice or white potato alone.   "
65633|NCT02426593|"     This study will be conducted to collect anatomical data in an ambulatory healthy population     to aid in the development of a novel non-invasive technology to assess changes in lung     hydration status. It will also help in developing reference ranges of lung hydration status     in healthy subjects and their associated changes with time.   "
65634|NCT02426580|"     This study is a prospective randomized controlled pilot trial. The investigators will use     wechat intervening dietary protein intake in patients treated with peritoneal dialysis.   "
65635|NCT02426567|"     Current evidence suggests that the gut microbiota and dietary influences are as important as     genetics in the aetiology of Crohn's disease (CD). We have recently shown that disease     improvement, following treatment with Exclusive Enteral Nutrition (EEN), coincided with     changes in the gut microbiota.      The main purposes of this study are: a) to explore whether the gut microbiota changes we     observed in this previous study in children with CD during EEN are disease specific or not,     and b) to develop a novel food-based diet (Crohn's Disease TReatment-with-EATing/CD-TREAT     diet) which will induce changes to the metabolic activity and bacterial composition of the     gut microbiota of healthy people, similar to those seen on EEN, the first-line treatment for     active paediatric CD.      This study will produce high quality scientific evidence to move the CD-TREAT diet towards a     preliminary clinical trial in patients with CD which is currently inappropriate and unethical     to carry out in people with active CD undertaking contemporary medical treatment.   "
65636|NCT02426554|"     The feasibility of combining a motor and cognitive exercise program with dietary     supplementation (DDU: Vitamin D, DHA and Uridine or Placebo) is tested in a smaller group of     prepubescent children.   "
65637|NCT02426541|"     This is an 8-week, single centre, randomized, parallel-group, double-blind,     placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific     insulin sensitivity in patients with Type 2 diabetes mellitus.   "
65638|NCT02426528|"     This cluster randomized trial will test the affect of individual participation in culturally-     and socially-related activities on health and well-being, in comparison also with the classic     individual determinant, in relation to urban renovation schemes. Investigators will using a     questionnaire based on several areas such as individual psychological well-being (PGWBI),     individual happiness positioning (Keyes Scale) and health status perception (SF-12 Health     Survey). Secondary outcomes will be related to social capital density (relationships and     trust), culture (participation) and religion. The survey will be undertaken in a mid-size     Italian metropolitan area, namely the Metropolitan City of Bologna.   "
65698|NCT02425748|"     In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation)     in combination with tumor reducing surgery, for example cryosurgery going to be investigated.   "
65639|NCT02426515|"     This study is looking to see whether cooling the face using a special cooling device     (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and     discomfort patients feel after the procedure. The surgical removal of lower third molars     (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this     study shows that application of cold before and throughout the procedure is a simple way to     reduce post-operative symptoms, it could benefit thousands of patients every year.   "
65640|NCT02426502|"     Patient failure to take medications as prescribed (medication non-adherence) is now     identified as an important cause of kidney transplant failure. The availability of new drugs     that are taken once daily may improve patient adherence compared to older drugs that had to     be taken twice per day. In this study, patients will be converted to a medication schedule     where all medications are taken once daily with the goal of improving patient adherence and     satisfaction.   "
65641|NCT02426489|"     The purpose of the study is to assess whether the addition of positron emission mammography     will add diagnostic value to magnetic resonance imaging of the breast, in patients with     lesions of the breast that are suspicious enough to warrant biopsy, or which have been     confirmed as containing cancer cells.   "
65652|NCT02426346|"     Community-based programs are needed to improve dissemination of efficacious treatment for     adolescent obesity. The current study aims to modify a community-based program, delivered     through the YMCA, to increase its effectiveness with adolescents. Adolescents will be     randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored     for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured     physical activity, and self-efficacy, assessed at 4 months and 10 months following     randomization.   "
65653|NCT02426333|"     The purpose of this study is to explore whether early abiraterone exposure is related to     treatment response in patients with metastatic castration resistant prostate cancer.     Furthermore to explore the relation between biomarkers and treatment response and drug     exposure.   "
65642|NCT02426476|"     Pain initiates a stress response that increases sympathetic output and leads to autonomic     imbalance. Heart rate variability (HRV) is a easy to perform, valid measure of autonomic     function. HRV biofeedback (HRV-B) is a novel biobehavioral procedure in which patients learn     to restore autonomic balance by developing 'HRV Coherence'. Patients in HRV Coherence have     improved mood and cognition. The investigators' pilot study showed that HRV-B alleviated     chronic pain and stress among Veteran Pain Clinic patients. HRV-B thus has a pivotal role in     managing pain. The proposed project is a randomized, sham-controlled, biobehavioral     intervention with HRV-B to test the hypotheses that HRV-B increases HRV coherence and reduces     pain, stress, fatigue, insomnia and depression and improves sleep, activity, and cognition in     Veterans with chronic neuromuscular pain. The investigators hypothesize that HRV-B will (1)     reduce self-reported pain and stress ratings, (2) improve objective measures of actigraphic     sleep parameters (sleep latency, duration, efficiency, fragmentation), rest/activity rhythms     (dichotomy index, interdaily stability) and cognitive function (reaction time, attention);     and (3) alleviate self-reported fatigue and depression symptoms. Patients from two groups     will be randomized to the investigators' previously established HRV-B or sham protocol (n=40     each), and will complete a baseline assessment, 6 weekly training sessions, a post-training     assessment, and 4-week and 8-week follow-up evaluations post-training. Portable, hand-held,     data-logging devices will be used to practice attaining HRV coherence at home by the active     HRV-B training group, while those in the sham training group will get a 'stress squeeze     ball'. Standard methods will quantify HRV coherence and other HRV measures, and validated     instruments will be used to assess pain, stress, fatigue, insomnia, depression, and cognitive     function. Wrist actigraphy will be used to objectively characterize insomnia via continuous     recordings collected 24-hrs/day over three 1-week periods (pre-training, post-training, and     at the 4 week follow-up assessments. Tests measuring attention and reaction time will assess     changes in cognitive performance. Data analyses will apply linear models for repeated     measures to evaluate the effect of HRV-B on study outcomes, and on treatment persistence,     after adjusting for confounding factors. This study will be the first to examine HRV-B for     pain management among Veteran chronic pain patients.   "
65643|NCT02426463|"     Children differ from adults with respect to growth and development but also immaturity of     various pharmacological mechanisms. Dosing schemes in children are usually derived in an     empirical manner from clinical trials in adult patient groups. All this poses neonates to an     increased risk for therapeutic failure and adverse drug reactions.      Medicinal products studied during this project are among the ones with the highest needs for     research in the pediatric intensive care. This project focuses on the necessity to integrate     subject's individual characteristics to assist clinical decision-making in drug therapy. The     investigators explore the mechanisms defining the dose response in pediatric populations. The     results obtained with these studies will help to find safer drug dosing regimens in this     delicate patient population.   "
65644|NCT02426450|"     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial     hepatectomy and liver transplantation are considered to be standard curative therapies for     HCC. When surgery is not possible, percutaneous ablation is usually considered to be     alternative treatments for HCC. Recurrence is the most frequent serious adverse event     observed during the follow-up of HCC patients treated for cure. Repeat hepatectomy is an     effective treatment for HCC recurrence, with a 5-year survival rate of 19.4 to 56%.     Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients     with HCC recurrence (10.4 to 31%), either because of the poor functional liver reserve or     because of widespread recurrence. Radiofrequency ablation has been considered to be one of     the most effective percutaneous ablations for early-stage HCC in patients with or without     surgical prospects. Studies using RFA to treat HCC recurrence after hepatectomy have reported     a 3-year survival rate of 62% to 68%, which is comparable to those achieved by surgery. RFA     is particularly suitable to treat HCC recurrence after hepatectomy because these tumors are     usually detected when they are small, and because RFA causes the least deterioration of liver     function in the patients. However, according to our previous study, investigators found the     recurrent rate after RFA was higher than 60%. Systemic chemotherapy is considered to be one     of the main treatments for malignant tumors. HCC is known to be highly refractory to     conventional systemic chemotherapy because of its heterogeneity and multiple etiologies.     Before the advent of the molecular-targeted agent sorafenib, which has subsequently become     the standard of care, no standard systemic drug or treatment regimen had shown an obvious     survival benefit in HCC. Nowadays, there is no systemic chemotherapy regimen had been     definitively recommended as the standard for treating HCC. Clinical activity of several     regimens containing oxaliplatin (OXA) in advanced HCC had been demonstrated in phase II     studies. In a phase II study of the FOLFOX4 (infusional fluorouracil [FU], leucovorin[LV],     and OXA) regimen in Chinese patients with HCC, median overall survival (OS) was 12.4 months,     mean time to progression was 2.0 months, and the response rate (RR) was 18.2%. The safety     profile was acceptable. Recently, the results of a phase Ⅲ randomize study showed that     FOLFOX4 served as palliative chemotherapy can induce higher overall survival,     progression-free survival and response rate comparing to doxorubicin in patients with     advanced hepatocellular carcinoma from Asia. The safety data was also acceptable. Therefore,     investigators considered RFA to be an effective treatment for HCC recurrence after curative     treatment. So our hypothesis is that RFA combined with FOLFOX4 can reduce high recurrence     rate after RFA for recurrent HCC after hepatectomy. The aim of this open-lable, single     prospective study is to evaluate the efficacy and safety of RFA combined with FOLFOX4     systemic chemotherapy for recurrent HCC after partial hepatectomy.   "
65645|NCT02426437|"     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations     result in frequent, prolonged hospitalizations. While originally considered a disease     specific to the lung, data has shown that COPD is associated with substantial cardiovascular     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with     stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown;     however, it may be due to chronic inflammation which is exacerbated with a flare-up of the     disease, and/or chronic inactivity which is similarly worsened with bed-rest during a     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.     Disease management programs, such as pulmonary rehabilitation and patient self-management     education, are part of guideline therapy for COPD; however, these are not regularly     implemented following a hospitalization, and how these interventions affect patient outcomes,     behavior, physical activity, inflammation and CV risk have not been well studied. The     proposed long-term project will examine how early referral to chronic disease management     programs after hospital discharge, affect patient outcomes. This study will provide     invaluable information about outpatient management for a disease which has a tremendous     impact on healthcare.   "
65646|NCT02426424|"     This is a prospective randomized open label trial with control-to-treatment cross-over. The     investigators wish to assess the effectiveness and safety of immediate detection and     treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients     with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better     neurological outcome and more successful rehabilitation.      The study will enroll 140 subjects which will be randomized into one of two arms:        -  Investigational - The sleep study will be performed during the index hospitalization          with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with          C-PAP both during the hospital stay and after discharge.        -  Control group -Will receive standard medical care. Patients will undergo sleep study at          3 months following discharge and patients diagnosed with sleep apnea will be treated          with C-PAP.   "
65647|NCT02426411|"     The study is a randomized, double blind, placebo-controlled, parallel-group comparison (two     dose levels of EMA401 versus a placebo group), of safety and efficacy in patients with     postherpetic neuralgia.   "
65648|NCT02426398|"     This is a non-invasive study investigating whether EEG, which is used in routine clinical     care can be useful in diagnosing dementia. Novel in house developed software will analyse EEG     data for this purpose from people with Alzheimer's disease and healthy volunteers.   "
65655|NCT02426307|"     TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However,     recent clinical experience has suggested that subclinical aortic valve bioprosthesis     thrombosis may occur early after valve replacement. The frequency of this potentially ominous     phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this     condition is difficult to detect.      The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise     for the evaluation of valve leaflet mobility and morphology.      The purpose of this study is in an observational design to assess the frequency of     subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or     surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon     as well as its relation to medical treatment and MACCE will be assessed.   "
65656|NCT02426294|"     The purpose of this study is to compare the treatment effect at week 26 between the two     groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD,     Pioglitazone) administration, as the third-order drug among patients whose treatment is not     sufficient after the combined administration of Metformin and Alogliptin.   "
65657|NCT02426281|"     Nab-paclitaxel (interchangeable with ABRAXANE and ABI-007) is a unique protein formulation of     a noncrystalline, amorphous form of paclitaxel in an insoluble particle state. Nab-paclitaxel     was designed to improve the chemotherapeutic effects of paclitaxel by exploiting endogenous     transport pathways to deliver higher doses of paclitaxel to the tumor and to reduce the     solvent-related hypersensitivity and other toxicities associated with Taxol® (paclitaxel)     injections, the solvent Cremophor EL, and ethanol vehicle. Nab-paclitaxel provides more rapid     tissue distribution and increased tumor accumulation compared to cremophor-EL paclitaxel.     Mechanistically, albumin receptor-mediated transport across the endothelium, binding to     interstitial proteins, and macropinocytic or receptor-mediated uptake into tumor cells as     well as sequestration of paclitaxel by cremophor-EL may contribute to the observed     differences. Furthermore, nab-paclitaxel synergizes with gemcitabine in preclinical models.     The Cremophor EL-free medium enables nab-paclitaxel to be given at a higher dose and in a     shorter duration without the need for premedication to prevent solvent-related     hypersensitivity reactions. As of March 2014, nab-paclitaxel is approved under the trade name     of ABRAXANE in over 45 countries/regions, including the US, Canada, India, European     Union/European Economic Area, South Korea, China, Australia, Bhutan, United Arab Emirates,     Nepal, New Zealand, Japan, Russia, Sri Lanka, Argentina, Hong Kong, and Lebanon for the     treatment of patients with metastatic breast cancer. ABRAXANE is also approved for the     first-line treatment of locally advanced or metastatic non small cell lung cancer (NSCLC) in     the US, Japan, Argentina, Australia, and New Zealand, for treatment of advanced gastric     cancer in Japan, and for first-line treatment of metastatic adenocarcinoma of the pancreas in     the US, EU/EEA, Australia, New Zealand and Argentina.   "
65658|NCT02426268|"     The purpose of this study is to measure cerebral and lower extremity oximetry on patients     during cardiac surgery.   "
65659|NCT02426255|"     The purpose of this observational epidemiological study is to investigate the management and     the complications associated with severe trauma. Data will be analysed to answer pre-defined     scientific projects and to improve management of these conditions.   "
65660|NCT02426242|"     Severe brain-injured patients require prolonged mechanical ventilation. Weaning these     patients from mechanical ventilation is challenging. During neurologic recovery, brain     injured patients usually present satisfactory respiratory autonomy. However, the exact timing     of extubation is unknown and is frequently delayed because of potential inhalation.      To date, there are no clinical signs available in the current literature that can help the     attending physician in the decision-making process of extubation in brain-injured-patients   "
65663|NCT02426203|"     Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy,     dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although     only carried out in a single UK centre, provides an excellent model for assessing right     ventricular function. Right heart function is most commonly assessed using echocardiography,     either transthoracic pre- and post-operatively, or transoesophageal intra-operatively.     Measurement of tricuspid annular plane systolic excursion is the best validated and most     commonly performed measurement for right heart function, however it may be inaccurate after     sternotomy and pericardial opening, making accurate assessment difficult immediately after     surgery. Therefore, we aim to compare established methods of assessing right heart function     with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel     reconstruction mechanism. Right ventricular function will be assessed in 51 patients who     undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened,     following the surgical procedure, using transoesophageal echocardiography, and at six-month     outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using     both modalities. This comparison should allow the investigators to determine whether such a     method could replace current measurement parameters for assessment of right ventricular     function, which is important for clinical management of patients in a variety of settings.   "
65664|NCT02426190|"     The objective of the KAROS study is to compare rehabilitation outcomes between 3 proposed     protocols and a current standard of care protocol for the purpose of identifying better     practice for outpatient rehabilitation among patients with single total knee replacement. The     3 advanced protocols involve use of an anti-gravity treadmill and/or the patterned electrical     neuromuscular stimulation (PENS). Both medical modalities have been cleared by the FDA to be     used in medical rehabilitation, including total knee replacement.   "
65665|NCT02426177|"     To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum     hypertension.   "
65666|NCT02426164|"     Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite     its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive     than other local anesthetic alternatives. The primary aim of this investigation is to examine     whether or not liposomal bupivacaine provides superior pain relief or clinically significant     opioid-sparing effects versus a control to justify its cost.   "
65667|NCT02426151|"     To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male     Subjects   "
65678|NCT02426008|"     The investigators suppose that adding growth factors that had been found in the female tubal     fluid and uterus to In Vitro single step culture media for human embryos might improve the     the embryogenesis In Vitro and the clinical outcome of the resulting off spring.   "
65709|NCT02425605|"     This is a single-center, single-arm, open-label, prospective phase 2 trial to assess the     efficacy of localized concurrent chemoradiation therapy (CCRT) and sorafenib sequential     therapy in subjects with advanced HCC. Approximately 47 subjects will be enrolled and will     receive CCRT and sorafenib sequentially until all-cause mortality.   "
65668|NCT02426138|"     Food insecurity, defined as difficulty accessing food owing to cost, affects 1 in 5 diabetes     patients. To address this, the investigators are conducting a pilot randomized controlled     trial of medically tailored meal delivery (MTM). The pilot study has two specific aims:      Aim 1: To determine the effect of receiving MTM on dietary quality for food insecure diabetes     patients with hyperglycemia Aim 2: To determine the feasibility and acceptability of the     program as a medical intervention and refine the program as needed for testing in larger     studies.      This study is a crossover randomized controlled pilot trial, where approximately 50     participants, 25 in each arm, will be randomized to receipt of 12 weeks of MTM, to begin     immediately, or waitlist control. After 12 weeks, the groups will crossover, with the     waitlist control group now receiving 12 weeks of MTM. At baseline, 12 weeks, and 24 weeks,     the participants will complete assessments of their dietary quality (HEI score), psychosocial     measures such as diabetes distress and food insecurity, along with measures of body mass     index, blood pressure, hemoglobin A1c, and lipids.   "
65669|NCT02426125|"     The main purpose of this study is to evaluate the safety and efficacy of the study drug     ramucirumab in combination with docetaxel in participants with urothelial cancer who failed     prior platinum-based therapy.   "
65670|NCT02426112|"     Chronic pulmonary disease (CLD) is the most common manifestation of HIV/AIDS among children,     accounting for more than 50% of HIV-associated mortality. Recently, a novel form of CLD,     affecting more than 30% of African HIV-infected older children was described by Ferrand et al     in Zimbabwe, high-resolution CT scanning findings showed predominantly small airways disease     consistent with constrictive obliterative bronchiolitis (OB). . Azithromycin has     anti-inflammatory activity and treatment of CLD with this agent may lead to suppression of     generalized immune activation.      This specific aims of this project are to:        1. Primary objective: To investigate whether adjuvant treatment with azithromycin results          in improvement in lung function in HIV-infected children with chronic lung disease, who          are stable on antiretroviral therapy.        2. Secondary objectives:             1. To investigate the intervention effect on mortality, exacerbations of lung disease,               quality of life, morbidity.             2. To investigate adverse events related to azithromycin treatment      In total, 400 children aged 6-16 years, living with HIV and diagnosed with CLD will be     enrolled at Harare Children´s Hospital in Harare (Zimbabwe) and Queen Elizabeth Central     Hospital in Blantyre (Malawi). These will receive weekly treatment with azithromycin or     placebo during 12 months. Another 100 children (50 per site) living with HIV but with no CLD     will be enrolled as a comparison group for laboratory sub-studies.      Lung function will be assess using spirometry and the Forced expiratory volume in the first     minute (FEV1) will be the primary outcome. The mean change in FEV1 z-score levels will be     compared between trial arms after 12 months of initiation of azithromycin treatment.   "
65671|NCT02426099|"     This is a four-week randomized controlled single blinded trial of subjects presenting with     resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly     assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to     routine intensification of antihypertensive regimen , all added to previous regimen with     unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four     following add-on therapy initiation. The primary outcome is change in office and     self-measurement blood pressure recorded at each visit, and secondary outcomes are variations     in serum potassium, sodium, and creatinine levels.   "
65672|NCT02426086|"     The purpose of this study is to evaluate the percentage of spleen (largest lymph organ in the     body) response and symptom response of 2 dose regimens of imetelstat in participants with     intermediate-2 or high-risk myelofibrosis (MF) who are relapsed after or refractory to Janus     Kinase (JAK) inhibitor treatment.   "
65699|NCT02425735|"     In this study, effects of γδT cells on human hepatocellular liver cancer in combination with     tumor reducing surgery, for example cryosurgery going to be investigated.   "
65673|NCT02426073|"     A thorough characterization of glucose metabolism and inflammaging in elderly subjects will     help determine to what extent each of these factors affects muscle mass/function and     contributes to age-related muscle wasting. The investigators will correlate patterns of     insulin secretion/sensitivity with muscle quality/quantity in diabetic and non-diabetic     elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic,     diabetic/sarcopenic), the investigators expect to identify an oxidative/inflammatory     signature (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific     for the sarcopenic phenotype and related to muscle insulin resistance.   "
65674|NCT02426060|"     The objective of this study was to determine the effects of Imrecoxib, an     anti-infiammatory/analgesic agent that primarily inhibits COX-2 and not COX-1 at therapeutic     doses, on the steady-state pharmacokinetic profile and hypoprothrombinemic effect of warfarin     in healthy volunteers.   "
65675|NCT02426047|"     The modified Atkins diet (MAD) has been shown to be effective in treating intractable     epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age     and women with epilepsy often have a pattern of seizures that correlates with their menstrual     cycle, called catamenial epilepsy. The investigators have observed that despite an overall     reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures     in a catamenial pattern. The investigators hypothesize that women with a history of     intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have     a catamenial seizure pattern will tolerate and be compliant with the addition of a daily     amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time     interval starting 2 days prior to and encompassing the primary catamenial pattern.   "
65676|NCT02426034|"     The purpose of this single arm study is to assess the safety and efficacy of ATAN (Apatinib)     in patients with Chemo-refractory Advanced or Metastatic Adenocarcinoma of Stomach or     Gastroesophageal Junction in clinical practice. ATAN will be given to patients who had failed     at least two lines of prior chemotherapy. Eligible patients will receive ATAN treatment (850     mg qd p.o.) continually until disease progression or intolerable toxicity or patients     withdrawal of consent, and the target sample size is 2000+ individuals.   "
65677|NCT02426021|"     The objective of the study is to investigate the safety, pharmacokinetics, and     pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.   "
65679|NCT02425995|"     Peroperatively observative study in pediatric orthopedic center in Lyon, France.      50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of     the medial meniscus associated with lesions of the anterior cruciate ligament.      All the patients need a reconstruction of the ACL because of chronic knee instability.      All the patients underwent a multi portal arthroscopy during the ACL reconstruction :     anteromedial and anterolateral and after intercondylar and posteromedial.      The study consists in a peroperatively arthroscopic look, in order to diagnose lesions of the     posterior horn of the medial meniscus which could be missed in MRI and anteromedial and     anterolateral arthroscopy.      Statistics of this lesions are used to study prevalence and diagnosis capacity of this     procedures.      First, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar     portal and after a posteromedial portal.   "
65680|NCT02425982|"     The study aims to investigate the natural course and the results of operative treatment of     chronic tennis elbow (TE). Chronic is defined as symptoms having lasted for more than a year.     The investigators will also study the effect of pain catastrophising on the subjective     outcome, the patient acceptable symptomatic state and the response shift phenomenon in TE.     The study will also ascertain the feasibility of a multi-center randomised, controlled trial     (RCT), and test and refine the co-operation and interaction of the planned RCT centers.   "
65681|NCT02425969|"     In this randomised controlled trial of patients with stable angina and documented     intermediate coronary disease with indeterminate or grey-zone Fractional Flow Reserve (FFR)     we will randomise patients to either optimal medical therapy alone versus optimal medical     therapy with PCI and they will be followed up for the primary endpoint of anginal control as     measured by the Seattle Angina Questionnaire at 3 months.   "
65682|NCT02425956|"     This study is being conducted to build a library of prospectively collected clinical data     from subjects with iron overload examined with commercially available MRI devices. This data     library is intended for use in future engineering development and other research activities,     including future regulatory submissions.   "
65683|NCT02425943|"     Study is designed to        1. to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a          single regimen for correction of wrinkle assessment score (WAS) 2 to 4 nasolabial fold          (NLF) contour deficiencies and other facial wrinkles in which deep dermal grid pattern          (cross-hatch) injection technique is appropriate.        2. to evaluate the time to onset, duration, severity, relationship to Sculptra Aesthetic          and/or injection procedure, and outcome of all adverse events during the course of the          study, by Fitzpatrick skin type.        3. to evaluate the change in the WAS from baseline to post-treatment follow-up time points          at Months 6, 13, and Years 2, 3, 4, and 5 in NLFs and other facial wrinkles.        4. to evaluate Investigator/subject global assessments at Months 6, 13, and Years 2, 3, 4,          and 5.   "
65684|NCT02425930|"     This study is designed to investigate whether complement C3 depletion is associated with poor     short-term outcomes in postoperative patients with gastric cancer.   "
65685|NCT02425917|"     This study is designed to compare the effect of IPC on post-operative circulation in lower     limbs with gekoTM device after total hip replacement procedure.   "
65686|NCT02425904|"     This research study is evaluating a drug called clofarabine as a possible treatment for     Langerhans Cell Histiocytosis( LCH )   "
65700|NCT02425722|"     The objective of this study is to investigate dose-responses of efficacy and safety of     ASP0456 in patient with chronic constipation (diagnosed by Rome III criteria of FC, not     including constipation due to organic diseases) compared to placebo and to investigate the     appropriate dose range for P3 study.   "
65687|NCT02425891|"     This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and     pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with     placebo in combination with nab-paclitaxel in participants with locally advanced or     metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy     for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been     determined in previous studies of participants with mBC and the safety data to date suggest     that atezolizumab can be safely combined with standard chemotherapy agents.   "
65688|NCT02425878|"     Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable     intramural fibroids not distorting the uterine cavity within a program OVD, after     administration of uPA in a dose of 10 mg orally daily for 12 weeks   "
65689|NCT02425865|"     PHASE: IV      TYPE OF STUDY: With direct benefit      DESCRIPTIVE: multicenter, open-label, uncontrolled trial      INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed     corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All     included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment     initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2.      OBJECTIVE: To determine the proportion of patients with continued clinical response (CCR) and     endoscopic remission at week 108, after discontinuation or de-escalation of golimumab     treatment at year 1 in the subgroup of patients in continuous clinical response (CCR) and     with mucosal healing (MH) (endoscopic Mayo score of 0 or 1) at week 54.      STUDY DESIGN:      Induction Phase :      Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg      Phase I : Week 10-Week 54 • Patients with primary clinical response* : Standard regimen with     golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg)      • Patients without primary clinical response* : Optimization to 100 mg Q4W (or combination     therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already     on azathioprine at golimumab initiation or patient with known intolerance to thiopurines)      • Early escape at Week 18: Primary non-responders who are still not responding at week 18 to     dose optimization at Weeks 10 and 14 will be considered treatment failures and will be     followed up (call or visit) at week 54 for safety.        -  Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3          points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from          baseline in the rectal bleeding sub score ≥1      Phase II : Week 54-Week 108      • Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab     and continuation of thiopurines or methotrexate if on combination therapy      • Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to     50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy      • Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I     dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)   "
65690|NCT02425852|"     PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open     label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare     the efficacy and safety of early administration of the combination therapy with infliximab     and azathioprine with steroids and azathioprine in patients with acute severe ulcerative     colitis treated with intravenous steroids.      STUDY TREATMENTS : All patients :      Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days.      Combination therapy arm:      Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day.      Azathioprine arm:      Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.   "
65691|NCT02425839|"     Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory     dysfunction and follow up of treatment effectiveness is currently based only on clinical     features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic     imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in     order to study its viscoelastic properties.      In this study, the investigators study the correlation between changes of shear wave     elastography modulus and surface electromyogram features of the masseters between rest and     maximal voluntary contraction.   "
65692|NCT02425826|"     This study will evaluate the clinical efficacy, the patients quality of life, and safety of     oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate     plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the     Extension Phase of the trial.   "
65693|NCT02425813|"     This phase II trial studies how well methylprednisolone sodium succinate works in treating     patients with graft-versus-host disease (GVHD) of the gastrointestinal tract that has begun     within 100 days of transplant (acute GVHD). Corticosteroids are a type of drug that reduces     inflammation. Giving corticosteroid drugs, such as methylprednisolone sodium succinate,     directly into the arteries of the gastrointestinal tract may help treat inflammation caused     by GVHD. Giving methylprednisolone sodium succinate in addition to standard treatments may be     more effective in treating GVHD.   "
65694|NCT02425800|"     This pilot research trial studies the use of a human prostate tissue model to maintain and     study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that was     removed during surgery from patients with non-cancerous enlargement of the prostate (benign     prostatic hyperplasia) and may create an environment similar to the natural environment of     the human body. Prostate cancer stem cells are cells that cause cancer to grow. Using real     tissue to create an environment to study stem cells may help doctors learn more about how     they work and how they respond to treatments.   "
65695|NCT02425787|"     Recent focus groups at St. Jude Children's Research Hospital (SJCRH) revealed several     limitations in our understanding of how parents' relationships with care staff help and     hinder their grief experience. Additionally, there is a gap in the bereavement literature     regarding the psychological effects professional caregiver relationships have on parents     whose children died of cancer. To bolster our knowledge base and benefit Bereavement Care     Services at SJCRH, as well as benefit other professionals by filling the gap in the     literature, we have designed a qualitative study that will conduct individual interviews with     bereaved parents whose children died at SJCRH.      Validation of the preliminary analyses of the initial 30 interviews will occur through new     focus groups involving two separate sets of bereaved parents who will validate the findings     and/or suggest additional avenues of inquiry needed to gain a more complete understanding of     parental grief/bereavement experience. Additionally, focus groups with hematology/oncology     fellows will obtain provider feedback on the value of these findings in their training and     future role as physicians.   "
65696|NCT02425774|"     Hypothesis:      Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an     anti-inflammatory effect.      Aims:      In the present pilot study, the investigators want to evaluate the anti-inflammatory effect     of prucalopride. The following aims are formulated:        1. to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve          stimulation (VNS)        2. to evaluate whether prucalopride leads to accelerated post-operative recovery   "
65697|NCT02425761|"     The purpose of the study is to compare the survival time (time to first shunt failure) of     ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted     through a posterior entry site in children. Shunt entry site is the location on the head that     the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the     ventricles. Entry sites can be anterior or posterior.   "
65701|NCT02425709|"     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in     reducing pain during outpatient hysteroscopy in postmenopausal women. Postmenopausal women     undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the     first group will receive Tramadol 50 mg 1 hour before the procedure, the second group will     receive diclofenac 50mg 1 hour before the procedure and the third will receive a placebo.     Pain will be assessed by a visual analogue scale.   "
65702|NCT02425696|"     The purpose of the study is to evaluate the prevalence and extent of right-to-left shunt     (RLS) in Chinese migraineurs, and the morbidity of silent cerebral infarction in migraineurs.   "
65703|NCT02425683|"     This study, for patients who have Stage IIIC colorectal cancer and who underwent     5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to     see if regorafenib given after the completion of FOLFOX improves treatment, compared to     standard of care (SOC), which is no further treatment.   "
65704|NCT02425670|"     The purpose of this study is to determine whether patients with subacute ischemic stroke will     benefit from infusion of patient's own bone marrow derived stem cells.      Primary Hypothesis: Intravenous injection of bone marrow mononuclear cells at a dose of 30 to     500 million in patients with subacute ischemic stroke results in reduction of infarct volume     and improvement of neurological function compared to those without the injection.      Secondary Hypothesis: Patients receiving more than 100 million Bone marrow derived stem cells     (BMSC) will have better outcome than those receiving fewer dosages of cells.   "
65705|NCT02425657|"     Specially educated trainers will be responsible for colonoscopy training of junior doctors.     The educated trainers will have attended seminars held by Valori et al.      The following fast track colonoscopy training program for junior doctors will consist of: 1)     Endoscopy simulation training and theory course 2) supervised and partly supervised lower     endoscopy. 3) Directly observed practical skills according to JAG (joint advisory group)     guidelines.   "
65706|NCT02425644|"     International clinical trial to compare ponesimod and teriflunomide in relapsing multiple     sclerosis   "
65707|NCT02425631|"     This study will evaluate long-term follow-up of subjects implanted with the SImmetry     Sacroiliac (SI) Joint Fusion System (SImmetry).   "
65708|NCT02425618|"     The purpose of this study is to investigate whether the pressure controlled ventilation can     reduce gastric insufflation compared to the volume controlled ventilation in patients who     were mechanically ventilated with the i-gel.   "
65710|NCT02425592|"     The objective in this study is to determine if MRI-identified progression can decrease     frequency or need for repeated prostate biopsy in men on active surveillance (AS).      Our hypothesis is that MRI alone is adequate to detect progression of prostate cancer in men     on active surveillance (AS) after a MRI-US fusion prostate biopsy.   "
65712|NCT02425566|"     The purpose of this study is to better understand the role of the abdominal veins (splanchnic     capacitance) and the sympathetic nervous system in human hypertension. The investigators will     test the hypothesis that constriction of abdominal veins due to sympathetic activation     contributes to human hypertension. Splanchnic capacitance will be assessed in normotensive     and hypertensive subjects at baseline and during acute blockade of the autonomic nervous     system.   "
65713|NCT02425553|"     Reflux and dyspeptic symptoms are common affecting 10-20% of the population on a regular     basis. Reflux symptoms such as heartburn and regurgitation are caused by the return of acid     or non-acid gastric contents into the esophagus. Dyspeptic symptoms are caused by abnormal     gastric relaxation (impaired accommodation) or increased sensitivity of the stomach to     distension during the meal.      The effects of diet on gastrointestinal function are debated and the efficacy of dietary     management for digestive symptoms has not been established. Epidemiological studies suggest     an effect; however, it is not possible to distinguish the effects of fat intake and total     energy (i.e. calorie) intake in this work. This issue has been addressed by small     physiological studies. The results show that esophageal acid exposure was related to total     calorie intake but not to fat content. In contrast, the number of reflux symptoms was 40%     higher after the high-fat than the low-fat meals. Similar findings were found for the     relationship between gastric distension, fullness and dyspeptic symptoms by Magnetic     Resonance Imaging. Thus, it appears that fat does not cause digestive dysmotility but     heightens sensitivity to visceral events and so increases the number and severity of symptoms     reported by patients. As yet, these findings have not been confirmed in larger, more     representative surveys.      Similar to the effects of food, there are inconsistent findings regarding the effects of     alcohol on gastro-esophageal reflux (GER) and gastric function. Physiological studies have     noted delayed gastric emptying and an increase in reflux events when alcohol is taken with     food. However, larger surveys have not confirmed that alcohol triggers reflux or dyspeptic     symptoms.      The proposed observational, dietary study with cross-over design will assess the independent     effects of energy intake (i.e. calorie load) and fat intake on gastric fullness, the number     and severity of reflux and dyspeptic symptoms after meals. The effect of alcohol on symptoms     after the high calorie, high fat meals will also be documented. The study population of     senior academics attending a conference are likely to have a relatively high prevalence of     risk factors for gastro-esophageal reflux disease (GERD) being predominantly male, with an     older age and a larger waist circumference than average in the general community. This will     increase study power and relevance of the findings.      The results will provide new information concerning the impact of dietary factors and alcohol     on digestive symptoms after meals. This data will inform future guidelines for the dietary     management of patients with reflux and dyspeptic symptoms after meals which will be relevant     in both primary and secondary care.   "
65714|NCT02425540|"     The aim of the study is to prospectively evaluate the value of pelvic MRI including     diffusion- and perfusion-weighted sequences in the selected group of patients that have an     undetermined ovarian mass at ultrasound.   "
65715|NCT02425527|"     The purpose of this feasibility study is to determine whether digital games are effective and     acceptable in the treatment for patients with traumatic brain injury.   "
65716|NCT02425514|"     The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior     Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.   "
65717|NCT02425501|"     The objectives of this study are to investigate the safety and effectiveness of EYLEA   "
65735|NCT02425267|"     The main objective of the study is to compare the clinical effects of the innovative     telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC     group) for patients treated for a proximal humerus fracture.   "
65736|NCT02425254|"     The purpose of this study is to test whether a dose of paracetamol given before surgical     incision is more effective at reducing postoperative pain and analgesic consumption in     cervical spine surgery versus a dose given at the end of surgery.   "
65718|NCT02425488|"     Purpose: Heart Failure (HF) is a clinical multifactorial syndrome, it can cause arrhythmias     for which international guidelines suggest the implantation of an implantable cardiac     defibrillator (ICD). The educational nursing program would improve clinical outcomes in     patients with HF and ICD like control their sickness, known and acknowledge symptoms, improve     their skills to self-care.      The main aim of this study is to assess how much the nursing-therapeutics skills and an     educational intervention, in patients with HF during the follow-up period after the     implantation of ICD reduces clinical costs, re-hospitalizations, and mortality at 180 days.      Methods: The investigators start a multicenter randomized clinical trial. The sample is made     of 128 subjects (64 patients treatment group and 64 control group). The investigators     measured the self-care level administering to HF patients the Self-Care of Heart Failure     Index (SCHFI) v. 6.2, and the self-perception of own life quality using a Numeric Rating     Scale from 0 to 100. Secondary outcomes recorded are i) the numbers of accesses to the ED     (Emergency Department) and/or hospitalizations during the follow-up period, ii) mortality     rate due to HF, and iii) infection rate of the device pocket.      Data Analysis: Categorical variables will be presented in terms of frequencies and     percentages. The statistical power was fixed at the 80%. Data will be considered significant     for a p-value ≤ 0.05. The Cox proportional hazards model will be used to analyze mortality in     subjects involved in the educational program.   "
65719|NCT02425475|"     All patients will undergo dermoscopic diagnosis and be documented with a video image storing.     The diagnosis based on dermoscopy will be immediately documented. Then, as a second     diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a     dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the     medical device LIMES will also be documented immediately. Afterwards, the lesion will be     excised and undergo histopathologic examination by the respective histopathologist of the     participating centers. The histopathologic diagnosis will serve as gold standard for     subsequent evaluations of the diagnostic accuracy.   "
65720|NCT02425462|"     This study is a prospective observational cohort study. The study will be conducted in     routine clinical practice settings. It is planned to enroll 870 patients with endometriosis     for whom a decision has been made by the physician to treat with dienogest according to local     health authority approved label. It is the aim of this observational cohort study to further     characterize the effectiveness of dienogest in improving quality of life and long-term safety     in routine clinical practice setting. Endometriosis is chronic and progressive disease and     there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be     good option for long-term treatment, however, experience with Visanne® beyond 15 month is     limited. And long-term up to 24 months data on effectiveness and safety of Visanne would     support the long-term treatment strategy for Endometriosis management in the clinical     practice.   "
72561|NCT02335983|"     The purpose of the study is to assess the safety, tolerability and activity of a once-weekly     regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment     of multiple myeloma.   "
65721|NCT02425449|"     Muscle relaxants are medications used during surgery to facilitate surgical access. The     effect of the muscle relaxant medications is measured by stimulation a motor nerve and     measuring the force of the resultant muscle contraction. Based on the mechanism of action,     two kinds of muscle relaxants are described. First a nondepolarizing muscle relaxant and the     second kind is the depolarizing muscle relaxant. These two kinds of muscle relaxants can be     distinguished by rapidly stimulating the nerve 4 times over 2 seconds (Train of four or TOF).     The nondepolarizing muscle relaxants produce fade ie successive muscle contractions are less     forceful than the preceding ones. Whereas the depolarizing muscle relaxants are generally     believed to produce four contractions of equal strength. However, there is some indication     that this may not be entirely correct. There is evidence that depolarizing muscle relaxants     also may produce fade. The investigators are conducting the following study to determine if     indeed depolarizing muscle relaxants produce fade. The investigators would also like to     characterize the fade ie differences during onset and offset of the block and the effect of     the dose on the degree on the fade.   "
65722|NCT02425436|"     The use of herbal medicinal products is increasing enormously in recent years, mainly among     women, who use them for the most varied purposes, such as in menstrual problems, menopausal     symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to     the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral,     antioxidant and antiinflammatory activities, as well as being used in the treatment of     osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from the     consumption of flavonoids, little is known about their safety and potentially harmful toxic     effects, such as mutagenicity and genotoxicity which might occur if taken in large doses .     Safety of Ginkgo biloba during pregnancy or lactation was not criticized in literature.     Roasted and raw ginkgo seed were not reported in the evidence-based medicine literature as     being either safe or contraindicated in pregnancy or lactation. A higher incidence of     postpartum hemorrhage was reported in the literature when associated with a 3-month ingestion     of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L. (Ginkgoaceae), a     medicinal plant widely used by the population . G. biloba has its origin in China, Korea and     Japan where its fruits and leaves have been used as food and medicine for a long time.      The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e.,     ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols     . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose     metabolites were found in the blood of rats and in human urine after oral administration of     EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used in     the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular insufficiency     and peripheral arterial occlusive disease . In folk medicine, EGb is used as a vermifuge, to     induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis and     edema . The aim of this study was to evaluate the effect of oral supplementation of Ginkgo     Biloba extract on the fetal weight as well as feto-maternal blood flow in cases of     intrauterine growth restriction.   "
65723|NCT02425423|"     The aim of this study is to evaluate the efficacy of a new thickened formula on     regurgitation.   "
65724|NCT02425410|"     The purpose of this study is to investigate viral factors determining the early onset of T1D.     Thanks to the quantification of viral exposures of T1D patients before the disease onset with     questionnaires and environmental databases analyses, and through whole genome association     studies of these patients, investigators could attempt to identify gene-virus interactions     determining the age of T1D onset.   "
65737|NCT02425241|"     This is a clinical proof-of-concept (PoC) study of DNA vaccination after SAP depletion. The     investigators will measure the immune responses to DNA vaccination against HIV-1 in healthy     adult male volunteers, comparing a group in whom SAP has been completely depleted at the time     of DNA vaccination and a control group vaccinated without SAP depletion.   "
65738|NCT02425228|"     This is a pilot study to determine cancer detection rate of conventional/systematic versus     targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a     diagnostic trial using each patient as his own control.   "
65739|NCT02425215|"     Background: Radiotherapy is a common treatment for many malignancies. Radiation-related     complications developing months or years after radiation treatment are known as late     radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors     who have received radiation.      Hyperbaric oxygen therapy (HBOT) is a well established treatment of LRTI. Most of the studies     evaluating effect of HBOT on LRTI are focused on survival, resolution of tissue damage and     improvement in LENT-SOMA scale. Very few studies have addressed effect of HBOT on pain in     LTRI. Krahn and colleagues were the first to report the analgesic effect of HBOT in 3 cases     of refractory pain in oncological patients with radiation soft tissue injury. Other studies     showed significant improvement in pain intensity in patients with breast cancer and pelvic     malignancies treated with HBOT for LTRI. In patients that had developed radiation- induced     brachial plexopathy, HBOT elicited an increase in warm pain thresholds and a reduction in     lymphoedema. A prospective case study of 16 patients with gynecological cancer found no     changes with respect to pain and depression outcomes. A trial in patients with radiation     induced proctopathy showed that 75% of patients with rectal pain had some improvement,     although none experienced a complete resolution of pain symptoms.      There are several mechanisms by which HBOT may elicit analgesic effects. There is a growing     body of evidence that HBOT's analgesic effect related to nitric oxide metabolism and     endogenous opioid secretion. Furthermore, the inhibition of tumor necrosis factor alph     (TNF-α), the production of substance P, and the modulation of serotonergic pathways have all     demonstrated a modification in the pain response following HBOT. In animal studies HBOT     decreased allodynia and hyperalgesia in different models of neuropathic and inflammatory     pain. The long lasting antinociceptive effect of HBOT was found to be dose-dependent in     non-injured tissues.      In human studies, HBOT decreased pain and edema and improved function in patients suffering     from the complex regional pain syndrome, and improved pain scores and range of motion in     patients with idiopathic femoral head necrosis. Women suffering from interstitial cystitis     demonstrated a reduction in pelvic pain following weeks and months of HBOT treatment. In     patients suffering from idiopathic trigeminal neuralgia HBOT produced a rapid reduction in     symptoms and these effects were lasting for 6 months following treatment. HBOT was also found     to be an effective treatment for cluster headaches and migraines and alleviated muscle and     bone pains in patients with myofascial syndrome, fibromyalgia, and biphosphonate-related     osteonecrosis of the jaw.      Based on the evidence presented above and HBOT's known analgesic effect in many conditions,     the investigators designed this study with the objective to evaluate if HBOT reduces pain,     improves depression and impacts on patients quality of life in patients suffering from late     radiation tissue injury.      Study Design: Prospective observational study (n=300). Patients that have had radiation     therapy for malignancy, developed late radiation injury and suffer from chronic pain.   "
65725|NCT02425397|"     A limited number of relatively contradictory studies have suggested that the development of     serious ototoxicity in children treated with cisplatin or, more rarely, carboplatin could be     partly related to genetic risk factors affecting detoxification enzymes and membrane     transporters of platinum derivatives. The objective of this study is therefore to identify     genetic variants associated with the development of platinum ototoxicity in patients treated     with cisplatin or carboplatin (minimum follow-up of 3 years) for one of the following     diseases: neuroblastoma, hepatoblastoma, retinoblastoma, malignant germ cell tumour,     osteosarcoma, high-risk or recurrent Wilms' tumour, non-parameningealrhabdomyosarcoma. A     total of 180 patients, corresponding to 60 cases with grade 3 or 4 ototoxicity and 120     controls with no signs of ototoxicity (separate complete audiograms for each ear) will be     included. A saliva sample will be used to obtain DNA for pharmacogenetic studies. The value     of this study will be to define a population at high risk of developing ototoxicity in order     to adapt treatment, or even develop preventive treatment of ototoxicity based on antioxidant     medications   "
65726|NCT02425384|"     The primary objective of this protocol is to test whether an activity monitor with an online     motivational rewards component will increase physical activity levels of middle school-aged     students. The secondary objective is to learn about the functionality and utilization of the     activity meter device among this age group.   "
65727|NCT02425371|"     Growing recognition of the importance of co-morbidities in Heart Failure with Preserved     Ejection Fraction (HFPEF) has led to the realization that rather than being a distinct     disease entity, HFPEF may represent a spectrum of co-morbidities in elderly breathless     patients. Accordingly, progress in managing HFPEF in the elderly requires improved     understanding of HFPEF pathogenesis with a focus on the impact of co-morbidities. However,     the available evidence is insufficient to determine the true prevalence and severity of     co-morbidities as well as their impact on both diagnosis and treatment in HFPEF. Therefore     there are widespread diagnostic uncertainty without proven therapy!      The purpose of this project is twofold:        1. The investigators will study how to improve diagnostic accuracy for HFPEF in elderly          patients, despite frequent comorbidities and higher age? How useful is it to add          exercise testing and contrast echocardiography as well as biomarker as additional          diagnostic tools in elderly HFPEF patients?        2. The investigators will test the hypothesis that HFPEF in the elderly is dominated by          multiple co-morbidities that are a major part of the syndrome itself that contribute to          the development of HFPEF. This hypothesis implies that the treatment of co-morbidities          will improve prognosis.      The investigators' overall goal is to bring about a paradigm shift in managing elderly     patients with HFPEF by not only improving diagnosis but also effectively treating     co-morbidities that are currently considered predisposing factors to HFPEF. This contrasts     with trials during last two decades that only target the heart.      The investigators will pursue the following specific aims:        1. Validate the diagnostic criteria for HFPEF proposed by European Society of Cardiology          2012, and determine the added diagnostic values of exercise testing and contrast          echocardiography as well as biomarker for HFPEF in a multi-center study.        2. Determine if systematic screening and optimal management of co-morbidities associated          with HFPEF improves the outcomes of patients with HFPEF in a randomized study.   "
67108|NCT02407353|"     This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled,     parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral     doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.   "
65728|NCT02425358|"     Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute     myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary     intervention (PCI); however, the optimal timing is unknown. The present study assessed the     therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).   "
65729|NCT02425345|"     The WHISH trial applies state-of-the science behavioral principles and currently available     technologies to deliver a physical activity intervention without face-to-face contact to     ~25,000 older U.S. women expected to consent. It includes an algorithm-driven interactive     voice response (IVR) system, built to complement the National Institute of Aging (NIA)     Go4Life® Exercise & Physical Activity materials 3, which provides tailored advice on how to     achieve nationally recommended levels of PA and overcome barriers to exercise, with a means     for self-monitoring and setting personal goals. The intervention builds upon evidence-based     behavioral science principles and intervention components that have proven to be effective in     increasing PA in older women, with innovative adaptive approaches to tailoring the delivery     to meet individual (personal) needs.   "
65730|NCT02425332|"     The aim of this study is the validation of a novel gait assessment method implemented in the     Lokomat gait trainer with respect to established clinical gait assessment methods. The     walking assessment method is based on the progressive reduction of the support of the device.     The outcome measures of this algorithm will be the support needed in the different gait     phases (guidance force of hip and knee joints) and the support required to the body weight     support system (unloading). The hypothesis is that the guidance force and the support of the     device will converge to a profile individual for each subject that is representative of one's     impairment in the different gait phases. The reliability of the method will be tested     collecting data from two sessions of Lokomat training. The validity of the method will be     tested comparing the outcome of the assessment task with established clinical walking     assessment measures.   "
65731|NCT02425319|"     The purpose of this study is to describe and to compare the motion analysis parameters, i.e.     motion and stability of proximal interphalangeal joints, which were treated with a     CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion     analysis of untreated healthy hands.   "
65732|NCT02425306|"     This study evaluates whether it is safe to administer a peptide vaccine in combination with     different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In     this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study     will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on     the immune system. The investigators will monitor these effects by performing tests in the     laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.   "
65733|NCT02425293|"     The aim of this study was to investigate the effect of standardized patient education on     asthma control. In collaboration with two health insurance companies, pharmacists and     pneumologists, patients with asthma were recruited. They completed the Asthma Control Test     (ACT) and the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire to     assess asthma control and patients' satisfaction with the health care service they received.     Additionally, patients were offered the possibility to participate in a patient education     seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year,     patients were asked to complete the questionnaires again. Comparisons of intraindividual     changes and differences regarding ACT and PACIC 5A between patients with and without patient     education were made.   "
65734|NCT02425280|"     This study aims to understand how war trauma affects children's and adolescents' memory     functions and mental health, and whether Narrative Exposure Therapy is effective in enhancing     optimal memory functions and alleviating mental health problems. The study analyzes the     mental health and cognitive and emotional healing mechanisms of therapeutic intervention     among war-affected children and adolescents.   "
65741|NCT02425189|"     The NLQTS Research Network team aims to build a Canadian collaboration of dedicated     investigators that will create a new paradigm in the modern investigation of patients with     LQTS and in the description of a new disease modifier.      The project aims to describe the natural history of familial Long QT Syndrome to identify:        1. Low risk patients that do not require protective beta-blocker therapy        2. High-risk patients that require protective beta-blocker therapy and may benefit from a          primary prevention ICD. This cohort would contain treated pre-symptomatic individuals          effectively protected from harm.   "
65742|NCT02425176|"     The efficacy of Botulinum toxin A (BoNT-A) in Asian population has not been properly studied     and there is no literature available on the most efficacious dose of BoNT-A for sialorrhoea     treatment. This research is aimed to find the dose of Dysport® that would be efficacious     without treatment-related adverse events and the duration of effectiveness of the drug for     sialorrhea treatment in Malaysian patients. The efficacy, safety, tolerability and adverse     effects of three doses of Dysport®(50MU, 100MU and 200MU) are examined at 2,6,12 and 24 weeks     post injection in this double-blinding, randomized trial.   "
65743|NCT02425163|"     Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate     Cancer detection.   "
65744|NCT02425150|"     The purpose of this study was to determine whether mechanical compression of the cornea     during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve     the optical outcomes of the treatment.   "
65745|NCT02425137|"     Primary Objective:      To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients     with advanced biliary tract cancer      Secondary Objectives:        -  To evaluate overall response rate (ORR)        -  To evaluate progression-free survival (PFS)        -  To evaluate overall survival (OS)        -  To assess the safety profile   "
65797|NCT02424461|"     This study will investigate the treatment of urinary tract infection (UTI) in men. The     investigators are looking to see if shorter duration of antibiotics (7 days) is not inferior     to a longer duration of antibiotics (14 days). The investigators will also study whether     longer treatment leads to an increase in antibiotic resistant bacteria in the gut microbiota     or an increase in drug side effects.   "
65798|NCT02424448|"     This is a biopsy feasibility study in which patients with castration resistant prostate     cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival and     de novo), blood samples, a urine specimen and clinical data for research.   "
65746|NCT02425124|"     A pragmatic cluster randomized controlled trial (RCT) in 20 public sector primary care     clinics in the Dr Kenneth Kaunda district of the North West Province of South Africa to     assess mental health and health outcomes for depressed adults receiving hypertensive     treatment by measuring the real-world effectiveness of a facility-based stepped care     intervention combining stress and depression case detection and management by non-physician     clinicians and referral pathways for anti-depressant medication and/or group/individual     counselling delivered by lay-health workers for patients with depression. The control     condition is enhanced usual primary health care where non-physician clinicians have been     equipped with the basic skills to identify stress and depression/anxiety but with limited     access to doctors authorized to prescribe antidepressant medication, and with no specific     psychosocial interventions.   "
65747|NCT02425111|"     The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by     ileocolonoscopy.   "
65748|NCT02425098|"     The purpose of this study is to assess the post-vaccination neutralizing antibody response     against each dengue serotype by treatment arm.   "
65749|NCT02425085|"     Previous pilot study has demonstrated that the novel multi-endodiathermy retinectomy is     feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled     eyes of adults over a 3-month observation.      Here, the investigators conduct this randomized and multicenter clinical trial to compare the     efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.   "
65750|NCT02425072|"     The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage     chemotherapy will significantly increase time to treatment failure in the brain of small cell     lung cancer patients.   "
65751|NCT02425059|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Rectal Neoplasms.   "
65752|NCT02425046|"     Low-income children and children of obese parents are at high risk of obesity. Effective     interventions are needed to target these families to improve the health of the parents and     prevent obesity in the children. The hypothesis is that an intervention that combines     engagement of community organizations, motivational interviewing (MI, a technique proven to     help people set goals that are personally meaningful), and resource mobilization will change     diet and physical activity habits among disadvantaged families. This proposal grew from an     established community-based participatory research (CBPR) partnership between the research     team and community organizations that serve high minority (45-55%), low-income populations.     Partners include a community health center, a food pantry network, a work-force training     program, and other agencies. These partners designed and implemented a successful pilot     project on which this proposal is based. The specific aims of this proposal are 1) To     evaluate the efficacy of a family-targeted obesity intervention based on MI and     resource-mobilization. Hypotheses: In comparison to control families, families participating     in the intervention will demonstrate a) a reduction in BMI for adults, b) an increase in     minutes of moderate physical activity and decreased sedentary time for both adults and     children accelerometer), and c) a reduction in the number of obesity risk behaviors and an     increase in obesity prevention behaviors among children. 2) To examine the mediators of     intervention effects. 3) Identify the types of resources needed most often by intervention     families to support lifestyle change. This randomized controlled trial includes 260     low-income families that contain at least one obese adult and one normal or overweight child     between 6 and 12. The 12-month intervention has two elements. 1) A health coach will use MI     to help families explore ambivalence toward and motivations for change and set goals for     improving diet and physical activity. 2) To support goals, families will be connected with     community agencies that can assist with general (e.g., financial) and goal specific resources     (e.g., food, physical activity opportunities). Collaboration between organizations will     streamline referrals, maximize resources, and facilitate access. Control families will get a     basic screen for needs and information about available community resources. Outcomes are     measured at baseline, 6, 12, and 18 months. This intervention is innovative in that it 1)     focuses on lifestyle changes for the entire family and measures outcomes in adults and     children, 2) combines MI focused on the entire family and community resource referrals     specific to family needs and goals for change, 3) partners community organizations to     coordinate resources for families, and 4) involves partners in all research phases via a CBPR     approach. This contribution will be significant because the proposed intervention, if     successful, can be replicated elsewhere and adapted to the local resource environment to     address adult obesity and prevent childhood obesity in a high-risk population. The study will     also identify the types of resources low-income families need to change diet and physical     activity.   "
65753|NCT02425033|"     This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM)     technique for lower esophageal sphincter myotomy in patients suffering from spastic     esophageal disorders such as achalasia at a Canadian institution.      The investigators hypothesize that POEM is a safe and effective technique for the surgical     management of such disorders at our institution.   "
65754|NCT02425020|"     The aim of this project is to investigate the potential benefits of combining a new protein     meat hydrolysates extract with a regular resistance training programme on (a) body     composition (b) performance (c) muscle structure (d) general markers health and immunity in     athletes. As a second objective the investigators will analyse potential differences obtained     from the ingestion of the new hydrolysates meat protein extract compared to the ingestion of     others commercially available protein sources such as whey or casein.   "
65755|NCT02425007|"     The purpose of this study is to evaluate the efficiency of incentive spirometry in elderly.     Outcomes are lung function and chest expansion.   "
65758|NCT02424968|"     This phase II trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work     as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant     in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and     anti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growth of     cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.     When the healthy stem cells from a donor are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.     Sometimes the transplanted cells from a donor can make an immune response against the body's     normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate     mofetil after the transplant may stop this from happening. Once the donated stem cells begin     working, the patient's immune system may see the remaining cancer cells as not belonging in     the patient's body and destroy them. Giving an infusion of the donor's white blood cells,     such as CD8+ memory T-cells, may boost this effect and may be an effective treatment to kill     any cancer cells that may be left in the body (consolidative therapy).   "
65799|NCT02424435|"     This study will explore whether methylprednisolone treatment is safe, well-tolerated, and     beneficial in patients that are diagnosed with Friedreich Ataxia (FRDA). The study will also     explore if methylprednisolone has any effects on biomarkers associated with FRDA. All     subjects in the study will receive the same steroid treatment.   "
65824|NCT02424110|"     The objective of the study is to make up the technique blind spots of the bipolar     radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic heart     disease by using argon beam coagulator. And to improve the rates of cardioversion of atrial     fibrillation after surgery, to decrease the long-term recurrence rate of atrial fibrillation     and to compare the early term and long term outcomes of bipolar radiofrequency ablation and     bipolar radiofrequency plus argon beam coagulator ablation.   "
65759|NCT02424955|"     Primary Objective:      The primary objectives of this prospective pilot study is to:        1. determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging          in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and        2. evaluate whether there are treatment induced early changes in imaging metrics derived          from 3D contrast enhanced ultrasound. This study will provide valuable insight as to the          potential of baseline and/or early post-treatment 3D ultrasound perfusion          characteristics (measurements of blood-flow) of primary and metastatic liver tumors to          predict tumor response to Stereotactic Ablative Radiotherapy. The investigators'          underlying goal is to assess whether early perfusion changes at 1-7 days after SABR          initiation can be used as a non-invasive early biomarker for treatment response          assessment.      Secondary Objectives:      Evaluate the feasibility of contrast-enhanced ultrasound-to-CT fusion by assisting     three-dimensional (3D) perfusion ultrasound (US) imaging with optical and electromagnetic     tracking of the ultrasound probe on patients with liver cancer that will undergo CT for     treatment planning and/or response evaluation.   "
65760|NCT02424942|"     Primary Objective:      To assess the safety and tolerability of ascending single intraarticular doses of GZ389988 in     patients with painful osteoarthritis (OA) of the knee.      Secondary Objectives:      To assess the pharmacokinetic (PK) parameters of ascending single intraarticular doses of     GZ389988 in patients with painful OA of the knee.      To obtain preliminary pharmacodynamic evaluation of ascending single intraarticular doses of     GZ389988 in patients with painful OA of the knee.   "
65761|NCT02424929|"     The goal of this study is to compare the surgical outcome of deep brain stimulation (DBS)     surgery in patients who are deeply sedated, asleep, or not sedated, awake, during     surgical implantation of the DBS electrode. The investigators hypothesize that the clinical     outcome, neurophysiological findings, and surgical accuracy will be equivalent. There are 3     specific aims: 1) compare the activity of the neurons in the patients' brain in the asleep     and awake groups using microelectrode recording, to see how this affects clinical outcome     capability of microelectrode recordings and macrostimulation to identify the subthalamic     nucleus in asleep patients. 2) Determine if intraoperative CT scans of the DBS electrode is     sufficient for accurate DBS electrode placement. 3) Compare the clinical outcome on their     Parkinson's disease between awake and asleep DBS patients.   "
65762|NCT02424916|"     This study evaluates the safety as well as the potential clinical efficacy of an adoptive     transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and     MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages     IIIc and IV).   "
65763|NCT02424903|"     The purpose of the study is to compare different approaches for the treatment of prosthetic     joint revisions and to optimize the outcomes in patients with prosthetic joint infections     (PJI) by improving the treatment concept of PJI.   "
65764|NCT02424890|"     The objective of this randomized trial is to study the effect of stress on performance and     the effect of repetition of simulation sessions on performance and stress. This study is a     randomized controlled trial including 48 participants who composed 12 multidisciplinary teams     (MDTs). Each MDT was made up of 4 persons: an emergency physician, a resident, a nurse, and     an ambulance driver who usually compose an emergency team of the French Emergency Medical     Service (EMS). 6 MDTs underwent 9 simulation sessions over 1 year (Repetitive SIm Group). 6     MDTs underwent 3 simulation sessions over 1 year (Control Group). Evidence of the existence     of stress was assessed in 3 ways: salivary cortisol, Holter parameters, and psychological     stress questionnaires. The impact of stress on overall team performance, on technical     procedure, and on teamwork, is evaluated by specific validated scales. Detection of     post-traumatic stress (PTSD) is performed by self-evaluation on the 7th day and after one     month. The perspective is to concomitantly evaluate technical and non-technical performance,     and the impact of stress on both. This is the first randomized trial studying repetition of     simulation sessions and its impact on both clinical performance and stress as explored by     objective and subjective assessments. The investigators expect that stress decreases team     performance and that repeated simulation increases team performance. The investigators expect     no variation of stress parameters regardless of level of performance.   "
65765|NCT02424877|"     The purpose of this study is to determine whether automated remote monitoring of patients     with early rheumatoid arthritis by the SandRA software and short message service of cell     phones increases patient compliance and helps to identify patients needing re-assessment of     medication before scheduled visits. This might result in better clinical outcome and     cost-effectiveness.   "
65766|NCT02424864|"     FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ     motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph     nodes. The investigators hypothesize that the metabolic signal obtained with motion     compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor     and lymph nodes.   "
65767|NCT02424851|"     The purpose of this study is to compare the effectiveness of bortezomib versus thalidomide in     reducing free light chains in the blood of myeloma patients. In addition participants will     receive bendamustine (chemotherapy) and dexamethasone (steroids), which increase the     effectiveness of both bortezomib and thalidomide. The trial will also study whether an     earlier reduction of free light chains increases the chances of the kidneys recovering.   "
65768|NCT02424838|"     After patients have been screened and have signed informed consent, they will be taken to the     endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration     (FNA), the subject will be randomized to 1 of 4 groups:        -  22 gauge (G) needle with suction        -  25 G needle with suction        -  22 G needle without suction        -  25 G needle without suction      Follow-up Phone Call Phase:      Unit staff will call patients 1 week after the procedure to check if patients had any adverse     events from the procedure and this will be recorded onto the dataset.   "
65836|NCT02423954|"     Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab     in subjects with advanced cancer.   "
65837|NCT02423941|"     To evaluate whether retrograde caval reperfusion of liver graft could be superior over     antegrade portal reperfusion in regard of incidence and severity of early allograft liver     dysfunction.      All eligible enrolled liver transplant candidates will be randomized to receive either:        1. retrograde caval, followed by sequential portal-arterial, reperfusion or        2. antegrade, sequential portal-arterial reperfusion.   "
65769|NCT02424825|"     The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS)     patients who are participating in a pilot cooking course. This online cooking training     program is currently available to general public through the company Rouxbe for a fee. Data     gathered from this cooking course will be used to develop novel ways of promoting healthy     eating habits in people with MS. The investigators will use the data from blood tests,     questionnaires, and demographics to assess the feasibility and effectiveness of this program.     This is an outpatient program designed for people with MS that would occur regardless of     whether participant data is collected.      This pilot cooking course will run for approximately four weeks. The investigators intend     start to the training course in mid-March 2015. Subjects will be followed prior to course     initiation for baseline data gathering, at four weeks from baseline, twelve weeks from     baseline, and twenty-four weeks from baseline.   "
65770|NCT02424812|"     The effect of large scale handwashing and hygiene promotion campaigns on handwashing     behaviour, diarrhoea and respiratory infections is not known. While Intensive small scale     interventions have achieved improvements in handwashing behaviour and reductions in diarrhoea     and respiratory infections, it is not clear whether realistic and scalable interventions     delivered across large areas achieve effects large enough to be of public health interest.     The Unilever School of 5 Lifebuoy campaign is such a scalable intervention that is being     rolled out across the state of Bihar during 2015 to 2017. The proposed study aims at     evaluation the effect of this campaign on handwashing behaviour in school aged children and     their mothers, and on diarrhoea and respiratory infections in the same children and their     younger siblings.   "
65771|NCT02424799|"     This First Time in Human (FTIH) study, which will be performed in three parts, is designed to     investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after     single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding     placebo within the same subject, in healthy adult subjects (Part A), subjects with cold     urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The     study will also measure short term effects of GSK2646264 on the number and size of weals in     subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.   "
65772|NCT02424786|"     The study aims to investigate adherence and polypharmacy in elderly patients with chronic     kidney disease (CKD) and End Stage Renal Disease (ESRD). The investigators look into possible     factors or predictors that may affect adherence and reduce polypharmacy. Factors could be:     quality of life, anxiety and depression, beliefs about medicine and cognitive impairment.      The investigators are planning an intervention with the screening tool Screening Tool of     Older Person's potentially inappropriate Prescription/Screening tool to Alert to Right     Treatment (STOPP/START ) criteria to evaluate medication lists of the participating patients.   "
65773|NCT02424773|"     In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high     case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the     most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has     been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC     and venturi mask on early respiratory deterioration and patient's comfort in that setting.     The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As     respiratory deterioration occurs early after ICU admission, patients are randomized to     receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint     is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary     endpoints include comfort, dyspnea and thirst.   "
65774|NCT02424760|"     The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a     Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve     severe pain or significant disability caused by degenerative pathologies. The rotator cuff     must be functional.      The aim of this study is to prospectively collect data from consecutive series to implement a     Post Marketing Surveillance plan.   "
65775|NCT02424747|"     The study evaluates how outcome varies among critically ill patients with and without acute     kidney injury. Data from the Swedish Intensive care register and other Swedish national     registers is used to compare how survival and post discharge renal function differ between     critically ill patients with and without acute kidney injury.   "
65776|NCT02424734|"     The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the     treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days   "
65777|NCT02424721|"     To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the     evaluation of patients admitting to the emergency department with suspected infection.   "
65778|NCT02424708|"     Glutathione is an important nutrient for brain function and loss of glutathione has been     implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of     three amino acids, the nutrients that make up protein. This study will determine whether     administration of either dose of glutathione, as a nasal spray, improves PD symptoms over     time in a population of individuals with Parkinson's disease (PD).   "
65779|NCT02424695|"     This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess     objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG     responsivity in patients with RLS. The study will include 8 visits over a period of up to 8     weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week     placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be     administered within 1 to 3 weeks after Screening/Washout. The total duration of the study     from the first subject enrolled to the last subject completed will be approximately 1 year.   "
66783|NCT02411591|"     This is medical research evaluating the safety and efficacy of two new medicines (necitumumab     and abemaciclib), administered in combination in participants affected by a defined type of     advanced lung cancer (stage IV non-small-cell lung cancer).   "
65838|NCT02423928|"     20 patients with invasive castration resistant prostate cancer and radiologically verified     metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell     based immunotherapy. Autologous dendritic cells will be obtained by leukapheresis and     elutriation and stimulation by cytokines. The induced dendritic cells will have to pass     viability, immunophenotyping and sterility criteria and will be injected into a cryoablated     region of the primary prostate cancer tumor. The treatment is supplemented by     immunomodulatory regimens.   "
65781|NCT02424669|"     Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is     considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in     mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that     leads irrevocably to death within 2 or 5 years of clinical onset.      Since there is no cure for ALS, the management of the disease is supportive and palliative.     Riluzole is the only drug that has been shown to extend survival by about three months. The     identification of biomarkers sensitive to the progression of the disease might enhance the     diagnostic and provide new drug targets.      Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of     interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS     patients. However, the cell origin as well as the pathogenic influence of this peripheral     source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS     and might be a potential biomarker of the disease.   "
65782|NCT02424656|"     This study explores the changes in whole-brain connectivity that occur during recovery from     severe Traumatic Brain Injury and how these changes are related to the recovery of     consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion     while patients are undergoing neurorehabilitation and after one-year of the TBI episode.   "
65783|NCT02424643|"     The purpose of this study is to test the efficacy of alternative methods to improve survey     completion.   "
65784|NCT02424630|"     The investigators compared the results of sono-guided interscalene brachial plexus block     (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB     alone within the first 48 h after arthroscopic rotator cuff repair.   "
65785|NCT02424617|"     A Phase I/2 multi-center open-label study of BGB324 in combination with erlotinib in patients     with Stage IIIb or Stage IV non-small cell lung cancer. BGB324 is a potent selective small     molecule inhibitor of Axl, a surface membrane protein kinase receptor which is connected with     poor prognosis and acquired resistance to therapy.   "
65786|NCT02424604|"     Aim The overall aim with this study is to improve outcome after inguinal hernia repair (IHR).     It is not known today if a re-operation due to recurrence after bi-layer mesh IHR is more     complicated than compared with the golden standard method.      Method This project is a registry study. The National hernia register (Svenskt bråckregister,     SBR) which started in 1992 include data that cover nearly 100% of all the country's hernia     operations.      Patient data are collected from SBR. Patients who at the time of surgery were between 18-75     years of age and operated on due to primary inguinal hernia with any of the two mentioned     techniques between 1992-2012 are eligible   "
65787|NCT02424591|"     Postoperative pain is severe after major spine surgery. Opioids such as morphine and     hydromorphone are routinely used for postoperative pain control. These drugs have significant     side effects, most importantly respiratory depression, nausea, constipation and tolerance.     Moreover, many spine surgery patients have used opioid pain medication for back pain long     term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led     to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated     side effects and tolerance.      Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses.     Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA     receptors are involved in central pain sensitization via wind-up phenomenon and altered pain     memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the     development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to     decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of     administration.      Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life     of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory     depression.   "
65788|NCT02424578|"     The purposes of this study are to evaluate the safety and tolerability and to model the     single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children     ages 6 to <17 years experiencing mild to moderate acute postoperative pain.   "
65789|NCT02424565|"     The rationale of this study is to map out changes in temperature distribution brought about     by topical application of our test product, and use this physiological phenomenon to     visualize the onset of action involved in overall mechanism of action of the product.   "
65790|NCT02424552|"     The purpose of the EVITA trial is to compare the effects of vitamin D therapy with placebo on     reducing the dose of inhaled or oral corticosteroids in patients with severe asthma and     vitamin D insufficiency.   "
65791|NCT02424539|"     This Phase IV interventional study is a multi-center, randomized, double-blind,     placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55     mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages     2 to 12 years with AR.      This study comprises screening and run-in period (4 to14 days), double-blind treatment period     (28 days) and follows up period (3 to7 days). Subjects entering the study will participate     for maximum of 50 days, including five clinical visits and a follow-up contact.      The study is planned to enroll approximately 360 subjects.   "
65792|NCT02424526|"     This study is designed to find the optimal dosage of home-based treadmill training needed to     accelerate walking onset and to examine the long-term effects on the child's walking     activity.   "
65793|NCT02424513|"     This is a prospective, multicenter, open-label, non-randomized study evaluating the ability     of [89]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by     pathology.   "
65794|NCT02423473|"     The aim of the present study is to evaluate the clinical, aesthetic and patient-centered     parameters of connective tissue graft associated or not with composite resin for the     treatment of gingival recession.   "
65795|NCT02424487|"     The purpose of this study is to evaluate the initial pressure and changes of the intracuff     pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.   "
65796|NCT02424474|"     The purpose of this study is to evaluate the performance of non invasive screening in a     population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to     regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement     and serum screening.   "
65800|NCT02424422|"     The aim of this study to test the immediate effect of rapid maxillary expansion on     craniofacial sutures in children using cone beam computed tomography.      Materials and Methods: Subjects consisted of 15 growing patients between the ages of 8 and 12     with Skeletal transverse maxillary deficiency with unilateral or bilateral posterior cross     bite.      All patients will be treated with A bonded Hyrax (a rapid palatal expander with an acrylic     occlusal splint). The planned activation protocol consisted of 2 turns per day (0.25 mm per     turn) until the resolution of posterior cross bite with 2 to 3 mm overcorrection of expansion     then tying off the jackscrew with a ligature wire and placing a smooth composite material     over it. The initial CBCT scan (T0) will be taken before cementation of the maxillary     expander and again immediately after the end of the active expansion (T1). First, all CBCT     images will be oriented then the craniofacial sutures(Intermaxillary Suture, Midpalatal     Suture, Transpalatal Suture, Internasal Suture, Frontonasal suture, Zygomaticotemporal     suture, Frontomaxillary suture, Zygomaticomaxillary suture, Nasomaxillary sutures,     Spheno-occipital synchondrosis) will be examined. Where the linear measurements will be     carried out directly on the CBCT image using the OnDemand 3D Imaging software program.   "
65801|NCT02424409|"     For over ten years, the French group ASUR (ASthme aux URgences) has studied the asthmatic     disease. The first epidemiological study enrolling 3.772 patients, in 37 emergency services,     showed that the treatment protocols during the acute asthma attacks were not homogeneous and     that oral corticosteroids were prescribed in only 50% of the cases. The second major French     study in the emergency department by the same group enrolled 3.049 patients. The results     showed that 38% of patients have a new acute asthma relapse in the month following their     consultation in the emergency department. In the same study, a multivariate analysis of     predictors of relapse showed that there are controllable factors (absence of written     recommendations at discharge, only 50% of prescriptions for oral corticosteroids at discharge     from the emergency department, limited follow-up by a general practitioner (GP) or     pneumologist ...).      The emergency physician has a responsibility in educating the patient during the period     between an acute asthma attack and return to the stability of long term therapy. To date, the     impact of patient education on the rate of further consultations in the emergency department     has not been proven, although it seems to be a positive trend on its effect. In France, half     of the patients coming to the emergency department for asthma attack will not be     hospitalized. More than a third will return to the ED within the first 30 days for a new     attack. The impact of post-interventional education on relapse should be explored. A first     major study on a strict formalized protocol designed to reduce the relapse rate is essential     and could allow a major improvement.      Our main objective is to assess the impact of a strict formalized protocol of care of     asthmatic patients discharged from the Emergency Department on the recurrence rate of asthma     attacks, one month after an asthma attack.      The expected benefit for the patient is the short-term reduction of relapse after asthma     exacerbations, thus avoiding the problems of readmission. The strict formalized discharge     protocol would also improve education in terms of self-medication in this gray zone of     post-therapeutic monitoring. The benefit is even more important in terms of public health due     to the important prevalence of asthma in the world and in our country. The advantage of this     protocol is to strengthen the links between the hospital and the GPs. Education of asthmatic     patients is essential in reducing morbidity. Thus, the potential benefits of this protocol     are: reducing the cost of health and re-hospitalization, improved education of asthma     patients, strengthening their link with the required GP, decreased absenteeism usually     frequent in this type of disease in the workplace.   "
65802|NCT02424396|"     Interleukin‐2 (IL‐2) was initially discovered and used as a stimulator of effector T     lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the     capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff     balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced     proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose     IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to     stimulate Treg and define potential clinical benefits   "
65803|NCT02424383|"     The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB     PTA Catheter in a heterogeneous patient population in a real world and on-label clinical     application.   "
65804|NCT02424370|"     Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat     symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve     replacement, it is still restricted to high surgical risk patient who are frail. The aim of     the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and     functional recovery after TAVR   "
65805|NCT02424357|"     1. To establish the culture positivity rate in adjustable suture strabismus surgery        2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms          cultured from suture material        3. To compare suture contamination rates with techniques to reduce the suture contamination          rate   "
65806|NCT02424344|"     The present study is planned to evaluate the effect of the aclidinium bromide/formoterol     fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in     patients with moderate to severe COPD. Additionally, the effect of the behavioural     intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both     on the exercise endurance and the physical activity.   "
65819|NCT02424175|"     This is an open-label single-arm pilot study to measure the microbiological and clinical     impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing     Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2     who also have concurrent inflammatory bowel disease Donor Stool from one healthy donor will     be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides     hospitals with screened, filtered, and frozen material ready for clinical use   "
65820|NCT02424162|"     This study will compare cataract patients with implantation of diffractive multifocal IOL     with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2).     Evaluations will be performed 1 and 3 months following cataract surgery, including     measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest     refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3     months, internal aberrations and contrast sensitivity will be evaluated and subjects will     complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.   "
65823|NCT02424123|"     Seizures represent an important clinical problem, accounting for at least 40% of adult onset     epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is difficult     due to the lack of prognostic biomarkers. Recent evidence has indicated that blood-brain     barrier (BBB) dysfunction constitutes an etiological factor to seizures. In particular, it     has been shown that modification of BBB permeability is associated with seizure activity. In     addition, it was demonstrated that BBB permeability can be assessed by measuring serum level     of the protein S100B. Based on these data and considerations the investigators will test     whether the extent of BBB damage at time of first seizure is predictive for seizure     recurrence.      The main objective of this study is to evaluate the association between the absolute (ng/ml)     serum S100B levels (measured at time of the first seizure) and the experience, or not, of     seizure recurrence within one year of follow-up.   "
65807|NCT02424331|"     This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the     kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in     patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study randomized     cross-over clinical trial and blind, in subjects with Chronic Obstructive Pulmonary Disease     (COPD) according to criteria of the Global Initiative for Chronic Obstructive Lung Disease     (GOLD) (FEV1 / FVC <0.7 and FEV1 <80% predicted) selected at the Clinical Hospital of the     Federal University of Pernambuco (UFPE) and Otavio de Freitas General Hospital (HGOF). The     investigators recruited 13 patients COPD (according to previous sample calculation) aged     between 40 and 80 years, of both sexes. The first day was held evaluation of lung function,     respiratory muscle strength, body composition, dyspnea index and functional capacity. On the     second day was held evaluation of thoracoabdominal complex kinematics by plethysmography     Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips breathing (PLB). Lung volumes     with 2 minutes with QB and 6 minutes PLB or only 6 minutes by QB as randomization were     observed. Before and after performing the requested breathing pattern diaphragmatic mobility     was observed by Ultrasonography (US) and requested the patient an Inspiratory Capacity     maneuver (IC). The evaluator who performed the ultrasound was blinded as to the beginning of     the breathing pattern of order performed by the patient.   "
65808|NCT02424318|"     The purpose of this study is to evaluate the effect of topiramate on cerebrovascular     reactivity and mean flow velocity to photic stimulation in migraineurs.   "
65809|NCT02424305|"     This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel     groups will be enrolled. The trial includes three active treatment groups. To be eligible for     inclusion in this trial, subjects must have at least 15 clinically typical, visible, and     discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of     approximately 250 cm2 of sun-damaged skin.      There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the     full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the     arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once     daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.   "
65810|NCT02424292|"     Patients diagnosed with breast cancer generally have a fairly well prognosis with estimated     average survival rates of 73% and five year survival rates of 89% in developed countries.     However, women who are obese at the time of breast cancer diagnosis seem to be at risk for a     worse breast cancer related and overall survival, as compared to their normal weight     counterparts. In addition, weight gain after diagnosis might be negatively associated with     prognosis.      Weight gain is a common phenomenon among breast cancer patients receiving adjuvant     chemotherapy as well as receiving adjuvant anti-hormonal therapy. While sufficient physical     activity and limitation of the amount of weight gain is important for all breast cancer     patients, it surely is for overweight and obese patients. The recently published national     guideline oncological rehabilitation provides exercise goals, for physical training based on     the Dutch PA guideline Nederlandse Norm Gezond Bewegen (NNGB). It recommends to engage in     moderate-intensity exercise (e.g. brisk walking) for at least 30 minutes a day, on at least 5     days a week. For people who are overweight (Body Mass Index ≥ 25 kg/m2) it is recommended to     exercise at least 60 minutes at a moderate-intensity level, equal or more than 3 Metabolic     Equivalent Task Hours (> 3 MET/h), on at least 5 days a week. However, only 61% of the     general population, meets these guidelines (8) and among cancer patients this percentage is     even less. This study aims to increase the percentage of overweight breast cancer patients     treated with adjuvant anti-hormonal therapy that reaches the goal of the NNGB by the     oncological rehabilitation program with 20%.   "
65811|NCT02424279|"     Pancreatic cancer is a difficult to treat disease, mainly due to the fact that diagnosis is     made usually in the late stage of this condition. One of the treatment methods of pain     accompanying this neoplasm is thoracoscopic splanchnicectomy. It has been shown that it is a     safe procedure with a small percentage of complications, nevertheless it is often use as the     last stage in pain management what significantly decreases its effectiveness.      The aim of this study is to determinate the effect of invasive pain treatment     (splanchnicectomy) in patients with advanced pancreatic cancer on subjective pain perception     at rest, in movement and after meals (measured with the BPI, QLQ- C30 and FACIT     questionnaires), and suffering (measured with PRISM projection test), the use of painkillers     during the disease and patients' overall survival. Moreover the investigators want to check     if early performance of splanchnicectomy (on lower steps of analgesic ladder WHO) is combined     with better therapeutic effect of this treatment.   "
65812|NCT02424266|"     The purpose of this study is to investigate the ability of an imaging device, developed by     AdOM Advanced Optical Technologies Ltd. (AdOM). The device allows a three-dimensional     imaging of the ocular tissues, specifically the tear film layers and the retinal layers. The     device is based on the use of white light.      In this initial study, the device will be used to assess the tear film which coats the     corneal surface in healthy subjects as well as in moderate-to-severe Keratoconjunctivitis     Sicca (KCS) or Dry Eye Syndrome (DES). The ability of the device to assess the retinal layers     will be evaluated in the second phase of the study.   "
65813|NCT02424253|"     This will be a randomized, double blind, placebo controlled, parallel group study in     approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12     and ≤ 48 (0-72 scale). Following a run-in subjects will be randomized to receive either oral     30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).   "
65814|NCT02424240|"     A 35-month cross-sectional observational study was conducted at an outpatient university     hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for     134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial     growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7     ng/ml [IRMA/ DiaSorin®], respectively in both clonidine stimulation and insulin tolerance     tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.   "
65815|NCT02424227|"     This is a prospective, multicenter, observational study of kidney transplant subjects where     blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn     after transplant   "
65816|NCT02424214|"     Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality     Oocytes and Teratozoospermia patients.   "
65825|NCT02424097|"     The objective of this clinical study is to evaluate the efficacy of multiple applications of     MI Varnish in combination with MI Paste Plus in caries protection and remineralization in     comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse     recommendation) in orthodontic patients in a randomized, single blind, prospective,     controlled clinical trial over 12 months.      The effect will be measured by white spot lesion regression and prevention as lesion count.     Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme     (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries     lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and     Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE     fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior     teeth with orthodontic brackets in treatment and control groups.   "
65826|NCT02424084|"     In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at     replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although     previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate bone     healing in case of non-union, only a few studies focused on the elucidation of its mechanisms     of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of     extracorporeal shock wave therapy on scaphoid bones and metacarpal and metatarsal in a human     in-vivo setting for the first time.   "
65827|NCT02424071|"     Melatonin has sedative, hypnotic and analgesic properties that make it a good premedication     agent before anesthesia and surgery.      In this study the investigators intend to randomise 60 patients undergoing bariatric surgery     into two groups. The participants will receive either melatonin or placebo on the evening     prior to the surgery, and the same agent two hours before the surgery.      The patients recovery from the surgery and anesthesia will be assessed using the Q0R15     questionnaire. The patients will be asked to take the questionnaire once in the pre-operative     clinic, again after the second melatonin or placebo pill before entering the operating room,     and once more on the first post-operative day.   "
65828|NCT02424058|"     The purpose of this study is to investigate the sagittal thoracic spinal curvature and     mobility in subjects with and without chronic neck pain, cut-off points and pain relationship   "
65829|NCT02424045|"     BCD (Bendamustine, carboplatin and dexamethasone)chemotherapy regimen is proposed as the     salvage treatment for relapsed or refractory PTCLs in this study protocol, which would be     expected to show more promising clinical outcomes than that of bendamustine single therapy.     Platinum combination with bendamustine is a theoretically ideal salvage regimen for the     patients of PTCLs because these both agents are highly effective drugs in lymphoma treatment     and have rare cross-resistance. Carboplatin was selected as a platinum agent for combination     with bendamustine, which is a second generation platinum agent and has a less neurotoxicity     than that of cisplatin, considering use for previously treated patients with vinc alkaloid     agents.      In a prior phase I study of carboplatin in combination with bendamustine for previously     untreated small cell lung cancer patients, the recommended dose for phase II studies was     bendamustine 100 mg/m2 on day 1 and 2, carboplatin AUC 5 on day 1, respectively [16]. In     consideration of previously treated subjects, however, the dose of bendamustine was decided     on 80mg/m2 in this study protocol with concerning about the toxicities, especially to severe     cytopenia.      Dexamethasone is one of the corticosteroids using a key drug for lymphoid malignancy and has     a strong antiemetic effect. Therefore, dexamethasone could enhance the therapeutic efficacy     and antiemetic effect, using with bendamustine and carboplatin.   "
65830|NCT02424032|"     The aim of this study was to investigate and compared the effects of cervical and     scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for     patients with chronic mechanical neck pain.   "
65831|NCT02424019|"     This study will assess the safety in patients treated with ILUVIEN, with primary focus on     IOP.   "
65832|NCT02424006|"     In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating     networks of recombinant human type III collagen and synthetic phospholipid -     phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection,     trauma or keratoconus. Control group will consist of patients with the same condition who     will undergo corneal transplantation - current standard of care.   "
65833|NCT02423993|"     The purpose of this study is to assess the effectiveness of structured group education on     glycemic control and Quality of Life (QoL) among users of continuous subcutaneous insulin     infusions (CSII).   "
65834|NCT02423980|"     This is an open-label, exploratory pilot study in patients with T1D. The study will involve     two daytime clinical research center visits 7-14 days apart. Subjects will receive a single     injection of G-Pen™ (glucagon injection) at each visit.   "
66784|NCT02411578|"     The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is     effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes.   "
65835|NCT02423967|"     The primary goal of this study will be to assess whether stool collected and frozen from     anonymous screened unrelated donors can be as effective as stool freshly collected from     recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent     Clostridium difficile infections in children. In the current protocols, which are more than     90% effective, each child who is receiving a fecal transplant has to provide their own donor     stool, usually from a parent or close relative. This requires considerable screening costs     for each case and is logistically complicated as the donor must be present and must stool     just prior to the transplant. The investigators hope to show that a small number of healthy     donors can provide stool samples which can be frozen and banked and then thawed for use in     numerous patients. The primary goal is to show that Clostridium difficile will be eradicated     as effectively (Greater than 90% success) when using the stool from the frozen donors.      The study will also evaluate the inflammatory response and intestinal microbiome in young     children aged 1-3 years with Clostridium difficile infections to better predict which ones     will respond to fecal transplantation and which ones have incidental infections. For this     question the investigators will gather stool samples to check for lactoferrin, calprotectin,     and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal     transplants. The goal is to see if there is an intestinal microbiome that predisposes some     children to getting sick from Clostridium difficile versus just having it incidentally.   "
65839|NCT02423915|"     T-cells are white blood cells that are important to the immune system. The T cells for this     study (called regulatory T-cells, or Tregs) will be from a donor who is not related to you.     Before the Tregs are given to you, they may be changed in the laboratory to make use of sugar     that is found in small amounts in blood cells through a process called fucosylation. They are     then called fucosylated Tregs. Adding more sugars to the Tregs in the laboratory is designed     to help the Tregs find their way faster to the bone marrow, which may help low blood counts     to recover faster.      The goal of this clinical research study is to learn if it is safe and practical to give     fucosylated Tregs to patients who will receive a matched related donor (MRD), a matched     unrelated donor (MUD), or cord blood transplant. Researchers also want to learn if these     Tregs may prevent or reduce the effects of graft-versus host disease (GVHD). GVHD can result     from a reaction of the transplanted cord blood cells against certain tissues in the body.   "
65840|NCT02423902|"     This is a single-arm, phase Ib/II study to examine the safety, tolerability and preliminary     efficacy of one cycle of Ad-RTS-hIL-12 immunotherapy in women with advanced breast cancer and     pre-study SD or PR after completion of a minimum 12 week course of standard first- or     second-line chemotherapy. The patient population will include patients with locally advanced     or metastatic breast cancer of all subtypes.   "
65841|NCT02423889|"     This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and     late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All     participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per     fraction.   "
65842|NCT02423876|"     This randomized clinical trial studies epidural anesthesia within an enhanced recovery     pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural     analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and     stops the feeling of pain. It stays in place for several days after surgery and may be     helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of     specific steps used before, during, and after surgery by health care providers to care for     patients after surgery. ERPs include patient education, not using laxatives before surgery,     increasing activity after surgery, and scheduled use of medications for pain and nausea.     Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing     gynecologic surgery.   "
65843|NCT02423863|"     The purpose of this study is to evaluate the safety of sequential intratumoral (IT) plus     intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and     carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of study subjects with advanced     accessible solid tumors   "
65844|NCT02423850|"     Diabetic foot ulcers and venous leg ulcers constitute an increasing health problem in Denmark     concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot     ulcers belong to the most serious and costly complications. Several studies have found that     the size and depth of the ulcer is one of the major etiologic factors for delayed healing.     Wound measurement is important in the monitoring of the wound healing process. For the last     decade different 3D techniques for measuring ulcers have been proposed in order to measure     ulcer volume, but none of the technologies have been widely used. A 3D photo-optical camera     has been developed, which is able to measure ulcer area and volume.      The investigators hypothesize that volumetric measurements of diabetic foot ulcers and venous     leg ulcers are feasible in the assessment of ulcer healing. A prospective cohort study is     conducted in which newly admitted patients with a diabetic foot ulcer or venous leg ulcer are     included at the first visit at the polyclinic. The patients are followed for one year or     until complete ulcer healing, amputation or death. Ulcer area and volume are measured by the     3D camera with frequent intervals. Patient anthropometrics and ulcer data are collected     during the study and correlated to the ulcer healing.   "
65845|NCT02423837|"     -  To evaluate the efficacy of bendamustine in combination with rituximab as first line in          patients with follicular lymphoma, 1-3A cytological type.        -  To evaluate the safety, tolerability and feasibility of bendamustine in combination with          rituximab as 1st line in patients with follicular lymphoma, 1-3A cytological type.        -  To evaluate the impact of the regimen modification (bendamustine dose modification          and/or extension of inter-cycle interval) into duration of complete and partial          responses.        -  To evaluate estimated treatment duration, reasons of treatment withdrawal.        -  To evaluate the possibility of unification and standardization of therapy protocol BR          (rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1-2).        -  To evaluate factors affecting overall and progression-free survival.   "
65846|NCT02423824|"     Cognitive deficits are a core feature across disparate brain disorders, being highly     prevalent and pervasive. Impairments in executive function are one of the most consistent     findings in clinical and meta-analytical studies and were reported to be a principal mediator     of psychosocial impairment and disability. Cognitive dysfunction is thought to be underlied     by abnormalities in distributed brain circuits, at the cellular and molecular levels.     Nonetheless, the neural mechanisms underlying the dysregulation in these circuits are poorly     understood. Emerging evidence indicates that metabolic abnormalities are highly relevant for     the domain of cognitive function and indicate that alterations in metabolic pathways may be     relevant to neurocognitive decline across different populations. The incretin glucagon-like     peptide-1 (GLP-1) is a hormone secreted by intestinal epithelial cells. GLP-1 receptors are     widely expressed in the central nervous systems. Pre-clinical trials have demonstrated     significant neuroprotective effects of GLP-1. Ongoing clinical trials measuring cognition and     mood in populations with various psychiatric disorders lend further impetus to explore the     effects of GLP-1R agonists on brain structure and cognitive function. We hypothesize that     GLP-1 and the GLP-1R are relevant for molecular and cellular processes that are thought to     underlie the formation and maintenance of brain circuits. A derivative of this hypothesis is     that the administration of GLP-1 agonists may result in enhanced neuronal survival and     consequential increase in gray matter volume. We therefore propose to explore the cellular     and molecular abnormalities within and between neural circuits subserving cognition using the     GLP-1R agonist liraglutide.      The overall goal of this study is to explore the relationship between a metabolic molecular     target (i.e. the GLP1 system), the neural circuits of interest and the behavioral phenotype     cognitive function.   "
65869|NCT02423525|"     The purpose of this study is to try to determine the maximum safe dose of afatinib that can     be administered to people with brain cancer. Other purposes of this study are to:        -  find out what effects (good and bad) afatinib has;        -  see how much drug gets into the body by collecting blood and cerebrospinal fluid for use          in pharmacokinetic (PK) studies;        -  learn more about how afatinib might affect the growth of cancer cells;        -  look at biomarkers (biochemical features that can be used to measure the progress of          disease or the effects of a drug).   "
68561|NCT02387320|"     This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to     determine the effectiveness of a self-care toolkit on specific symptoms associated with     surgery as compared to a standard care group.   "
65847|NCT02423811|"     Esophageal cancer is a common and fatal malignancy. It is the eighth most common incident     cancer and the sixth leading cause of cancer death in the world. In Taiwan, esophageal cancer     was newly diagnosed in 2199 patients and was the cause of 1507 deaths in 2011. Squamous cell     carcinoma is the predominant histological tumor type, accounting for about 90% of the cases.     Esophageal squamous cell carcinoma (ESCC) is an aggressive disease, characterized with     extensive local growth and frequent metastases. Concurrent chemoradiotherapy (CCRT) with or     without surgery is the treatment option for locally advanced ESCC. Further, target therapy is     used in conjunction with CCRT and surgery in ESCC since several years ago. However, the     therapeutic outcomes are not satisfactory due to the emergence of chemo-radioresistance. It     is imperative to investigate new biomarkers and to find novel treatment targets in ESCC.      A small population of tumor-initiating cells or cancer stem cells (CSCs) possess some     biological functions like normal stem cells, including self-renewal, asymmetric cell     division, slowly proliferation rate and drug-resistance. CSCs from many primary tumors and     cell lines express specific stem cell markers, including Oct4, Sox2, Nanog, CD133     (promimin-1), Nestin, CD44 ,CD24, ALDH (Aldehyde dehydrogenase) and c-Kit. There are many     evidences that CSCs are responsible for tumor initiation, progression and metastasis. CSCs     are also believed to have important roles in cancer recurrence due to their resistance to     anti-cancer drugs and radiation. CSCs express high levels of ATP-binding cassette (ABC)     transporters. ABC transporter can pump cytotoxic drugs out of cells and is one important     mechanism of multidrug resistance in CSCs. In addition, CSCs have high reactive oxygen     species (ROS) scavenger expression to remove ROS produced from irradiation therapy.      Fursultiamine (also known as thiamine tetrahydrofurfuryl disulfide, TTFD) is a derivative of     vitamin B and currently used for nutrition supplement. The investigators have identified that     Fursultiamine suppressed OCT-4, SOX-2, NANOG expression and decreased ABCB1 and ABCG2 in     tumor sphere of ESCC cell lines. In this project, the investigators will conduct a     prospective phase II study to investigate the effect of Fursultiamine combined with CCRT in     ESCC patients. Stem cell markers in clinical specimens collected before and after CCRT will     be evaluated.   "
65848|NCT02423798|"     The trial will investigate the accuracy and performance of a new sensor for continuous     glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with     the new Medtronic 640G system components.      To evaluate the accuracy and performance of the new generation Enlite sensor. This is a     postmarket, interventional, open-label, non-randomized, single center clinical research     trial.      The trial will adopt a prospective single-sample design using the Yellow Spring Instruments     (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood     glucose (SMBG) plasma glucose reference sampling procedure at home.   "
65849|NCT02423785|"     In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of     treatment regimens in the metastatic setting. Addition of bevacizumab to conventional     chemotherapeutic combination regimens has improved the median overall survival of advanced     colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit     from anti-angiogenic approaches, would be highly desirable in order to optimize treatment     strategies. Changes in ocular blood flow may be an attractive biomarker for predicting     treatment response. In light of the given alternative first line treatment options such a     predictive biomarker would be of clinical benefit. In the proposed study the investigators     will assess potential changes in the ocular blood flow of mCRC patients after treatment with     standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of treatment     response as assessed by standard CT-scan   "
65850|NCT02423772|"     Chronic pain and misuse of opioids is a major public health problem, particularly in military     veterans. The major goal of this project is to test the efficacy of an innovative behavioral     treatment for chronic pain patients who are misusing prescription opiates. This project     supports the strategic goals of National Center for Complementary and Integrative Health     (NCCIH) and National Institute on Drug Abuse by examining a difficult and understudied     problem with the ultimate goal of impacting scientific knowledge and human health.   "
65851|NCT02423759|"     The aim of the study is to evaluate whether changing antibiotic prophylaxis from     fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted     antibiotic prophylaxis according to rectal swab culture would influence infectious     complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.   "
65852|NCT02423746|"     Purpose:      This study is a feasibility trial of an existing evidence-based behavioral parent training     program with parents of preschool-aged children who were born deaf or hard of hearing (DHH).      The hypotheses of this study are (a) that a randomized control trial of the Family Check Up     with this population will be feasible, (b) parents will rate the intervention as acceptable,     and (c) a signal of effect will be observable among intervention group parents compared to     controls for the following outcome variables: child behaviors, parenting behaviors, and     parenting sense of competence.   "
67421|NCT02403245|"     The aim of this study is to evaluate the direct impact of one session of social stimulation     on social interactions of people with moderate dementia living in nursing home in comparison     of one session without direct social stimulation.   "
65853|NCT02423733|"     Depression is common and disabling but access to specialist treatment is often delayed with     waiting lists of up to a year not uncommon. Also treatment is frequently limited to drug     therapies because of long waiting lists to see psychological therapists face to face despite     recommendations by NICE (The National Institute for Health and Clinical Excellence) and     others about the importance of non-drug therapies. One way to address this problem is to use     computerized e-therapies which deliver structured cognitive behavioral treatment where the     therapy can be accessed in a location and at a time that is convenient for patients and where     there is no waiting list. Previous randomized controlled trials of e-therapies for depression     have mainly been in people recruited through the internet or in clinical populations with     mild disorders where many participants do not complete the on-line course. Despite this there     is some evidence that clinician-assisted computerized cognitive behavior therapy can result     in significant improvements in depression with reduced demands on clinician time. To date     there have been no trials of clinician assisted e-therapy in secondary care.      Therefore the aim of this clinical trial is to answer the question In patients on the     waiting list for the mood program does a computerized therapy with an e-therapy coach     compared to written information about depression and the availability of computerized     treatments result in better outcomes, quicker improvements and the use of fewer resources     after 12 weeks. The study will be a randomized controlled trial with health service use and     PHQ-9 as the main outcome measures.   "
65854|NCT02423720|"     This is a audio based mindfulness meditation intervention for colorectal cancer patients and     caregivers. A 8-week single arm study will be conducted among UCSF patients with metastatic     colorectal cancer undergoing chemotherapy and caregivers of these patients (44 participants     total).   "
68562|NCT02387307|"     This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous     injection for 21 days, with 1 week of washout per cycle).   "
65855|NCT02423707|"     Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic     rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the     long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT     requires numerous subcutaneous allergen injections and takes several years to complete.     Hence, there is a need to develop more convenient protocols for induction of allergen     tolerance.      Emerging evidence suggest that by targeting of antigen presenting cells within the lymph     nodes the immunogenicity of the allergen can be enhanced and the number of injections can be     reduced.      The purpose of this study is to evaluate whether intralymphatic administration of ASIT is a     safe and effective treatment for patients with pollen-induced allergic rhinitis. The long     term goal is to provide a base for a more efficient administration of ASIT, which will reduce     both the dose necessary and the number of clinic visits associated with the conventional     subcutaneous ASIT.      The investigators will make an attempt to reproduce the results of a recent human study of     intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting.      The first part of the study is completed and published (PMID: 23374268)   "
65856|NCT02423694|"     Main objective: to compare the effects of electro-acupuncture and escitalopram oxalate     tablets on mild-to-moderate perimenopausal depression, and to evaluate the safety of     electroacupuncture stimulation.   "
65857|NCT02423681|"     To compare a group of patients with our standard treatment of continuous positive airway     pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The     therapy cost and the successfulness of the treatment will be measured. A humidifier is a     water chamber that is currently added to CPAP only if the patients needs it.   "
65858|NCT02423668|"     To study the effective lens position concept in second eye refinement (SER) cataract surgery,     by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pACD) measured in     Pentacam and SER refractive outcomes.   "
65859|NCT02423655|"     This study evaluates the efficacy and safety of deferred dialysis initiation in Chinese     population. 16 tertiary hospitals across China will be randomly assigned into routine and     deferred dialysis groups.   "
65860|NCT02423642|"     The purpose of this study is to study the effect of anticoagulation in immune response with     Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).   "
65861|NCT02423629|"     Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral     defects.   "
65862|NCT02423616|"     This study aimed to examine the possible relationship between hand grip strength (HGS) and     maximum inspiratory pressure (MIP) in healthy individuals.   "
65878|NCT02423395|"     Muscle cramps are common in patients with liver disease and associated with significantly     diminished quality of life. Patients with cirrhosis often experience muscle cramps with     varied frequency and severity. The exact mechanisms by which they occur remain unclear,     although a number of pathophysiological events unique to liver disease may contribute.     Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism,     and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent     central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and     other similar conditions. The combination of anticholinergic effects and CNS penetration make     orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and     headaches. [3,4]   "
65879|NCT02423382|"     The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil     on retinal saturation with Oxymap.   "
65864|NCT02423590|"     This study is being carried out to see if a new drug called Apatorsen in combination with     standard gemcitabine/carboplatin chemotherapy is effective in treating squamous cell lung     cancer.      This study is part of a research project for collecting information about the effectiveness     and safety of Apatorsen when used with gemcitabine/carboplatin chemotherapy. The main purpose     of this study is to see if Apatorsen, when combined with gemcitabine/carboplatin, is an     effective treatment for squamous cell lung cancer.      Recent research has found that a protein called Hsp27 can help cancer cells protect     themselves against the effects of cancer treatments. Hsp27 is only found in some lung cancers     but when it is present, cancer drugs might not work as well as they would without Hsp27 being     present. Blocking the action of Hsp27 or removing Hsp27 from cancer cells with Apatorsen may     slow down or stop the cancer growing. This study will therefore look at the relationship     between the Hsp27 levels in tumour and blood and the effect of the treatment.      The development of Apatorsen is intended to provide a new treatment option for patients with     cancer. Apatorsen may also make the cancer more sensitive to gemcitabine and carboplatin and     so make this chemotherapy treatment more effective.   "
65865|NCT02423577|"     The purpose of this study are to determine the effect FF-3 in comparison to placebo in     subjects who are experimentally inoculated with a live, challenge strain of influenza A     virus.   "
65866|NCT02423564|"     This investigation will evaluate the effect of Digesta-Lac in adults with occasional     constipation in a single-center, randomized, double-blind, placebo-controlled, parallel group     2-arm study for 3 weeks.   "
65867|NCT02423551|"     The objective of this study is to determine the impact of consuming MREs as the sole source     of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80     free-living adults will be randomized to consume their usual diet or only MREs for 21     consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research     Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be     collected periodically before, during and after the intervention to measure gut barrier     integrity, gut bacteria community composition, and markers of gut health, inflammation, and     nutritional status.   "
65868|NCT02423538|"     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)     oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics     (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the     maximum tolerated dose determined.   "
65887|NCT02423278|"     The main purpose of this study is to evaluate the effect of extensive lymphadenectomy     procedure in treatment of gastric cancer. This study is designed as a open-label,     multi-centers, randomized controlled trial. The overall survival and free disease survival     are primary outcomes, with postoperative complication, hospital charges, and life quality as     secondary outcomes.   "
65870|NCT02423512|"     Vedolizumab is a new medication being used for the treatment of Crohn's disease and     Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7     lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous     studies have shown that patients who have previous exposure to another type of medication for     Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab     as well as those who have never been exposed. This study will investigate biologic markers in     the blood and tissue the help identify possible reasons for this difference.   "
65871|NCT02423499|"     The objective of this study is to identify the specific characteristics of Autism Spectrum     Disorder (ASD) in emotional response profiles and shared with Bipolar Disorder (BD)     characteristics.   "
65872|NCT02423486|"     The aim of this study is to compare the efficacy between Electromagnetic Stimulation therapy     and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary     Incontinence patient.   "
65873|NCT02423460|"     The daily requirement of threonine, an essential amino acid, will be evaluated in healthy     adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator     amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with     varying levels of threonine.   "
65874|NCT02423447|"     It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum     weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for     airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung     health and perform AC at home as part of their routine therapeutic regimen.   "
65875|NCT02423434|"     Through the multinational pooled dataset approach, this trial will aim to derive and validate     specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the     identification of diabetic polyneuropathy, and - more importantly - the identification of     individuals at future risk. Results of the study will permit application in clinical practice     and intervention trials for diabetic polyneuropathy (DPN) risk stratification.      The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes     with and without neuropathy, who had CCM performed in the past as a part of their     neurological examination, to assess concurrent and predictive validity of different CCM     parameters in individuals . These subjects will be invited to the study to be re-examined by     CCM along with other neurological tests (physical exam, nerve conduction studies,     quantitative sensory testing, blood test and in some centres also skin biopsy) during the     single study visit. Additionally CCM data will be analyzed both manually and by recently     developed automated analytical software to evaluate accuracy of the automated method.     Evaluation of automated image analysis will influence likelihood of successful knowledge     translation of this surrogate biomarker for DPN into clinical practice - in which the     procedure could be harmonized with annual retinal examinations - and into intervention     trials.      Secondary aim of the study is to determine the factors associated with CCM parameters and     their longitudinal change and collect bio-samples for future research in this field.   "
65876|NCT02423421|"     The purpose of thus study is to determine if faecal microbiota transplantation will result in     improvement in clinical outcomes in patients with irritable bowel syndrome.   "
72038|NCT02343016|"     The aim of the investigators work is to describe the agreement between NIRS and ecodoppler,     as monitoring systems of liver and kidney graft's perfusion in the immediate postoperative     period in pediatric patients.   "
65880|NCT02423369|"     The purpose of this study is to assess whether peri-operative period in neonates and infants     is associated with an increase in blood biomarkers, specific for neuronal injury, and to     correlate them with clinical variables and sedative/analgesic agents. Patients, who meet     inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for     measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are     drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During     surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic and     respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and     postoperative treatment, including analgesia and sedation, are given as per standard of care.   "
65881|NCT02423356|"     The purpose of this study is to investigate the heart functioning of patients being treated     with with doxorubicin chemotherapy who have sarcoma, lymphoma or breast cancer in order to     better predict risk of developing symptomatic heart failure.   "
65882|NCT02423343|"     The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the     study drug known as galunisertib in combination with nivolumab in participants with advanced     refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC) or     hepatocellular carcinoma (HCC).   "
65883|NCT02423330|"     This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to     treat anal fistulas.   "
65884|NCT02423317|"     The Airtraq optical laryngoscope has recently been available in pediatric sizes. The     investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation     devices in paediatric patients. This prospective, randomized study was conducted in a     tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade I-II     paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation     were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30)     laryngoscope. The primary outcome measures were time of intubation, ease of intubation,     number of attempts and POGO score. We also measured hemodynamic changes and airway trauma.   "
65885|NCT02423304|"     50 periodontitis 50 healthy individuals serological evaluation will done to see association     of 77A/G AND 11A/12A gene polymorphisms of MMP-13   "
65886|NCT02423291|"     Study Objectives Primary:      • To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg     administered intravenously every 3 weeks) as measured by the overall objective response rate     in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.      Secondary:        -  To assess duration of tumor control, including duration of response and progression-free          survival        -  To assess survival        -  To assess the safety and tolerability of Brentuximab vedotin      Additional:      • To assess disease-related symptoms      Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study     The study duration is 18 months for enrollment and 2 years for the follow-up.   "
65888|NCT02423265|"     Anti-anginal drugs relieve ischemia and symptoms by reducing myocardial oxygen demand by     reducing heart rate and or contractility (beta-blockers, phenylalkylamine and     benzothiazepineate classes of calcium antagonists) or vasodilatation of the venous system     (fall in pre-load) and coronary vessels.      Late sodium channels remain open for longer in the presence of myocardial ischaemia.     Ranolazine, a novel anti-anginal agent, acts by inhibiting the inward late inward sodium     current (INaL), reducing intracellular sodium accumulation and consequently intracellular     calcium overload via the sodium/calcium exchanger. It is currently thought that this     reduction in intracellular calcium reduces diastolic myocardial stiffness and therefore     compression of the small coronary vessels. There is considerable animal data to support this     theory.      There are good theoretical reasons to postulate that patients with chronically occluded     vessels may derive less benefit from conventional anti-anginal agents, particularly     vasodilators. The ischemic myocardium, subtended by the occluded vessel, will already be     subject to significant concentrations of paracrine vasodilators such as adenosine.     Ranolazine, therefore, may on the basis of its mechanism of action, provide greater relief of     ischemia in such patients than conventional anti-anginal agents.   "
65889|NCT02423252|"     The purpose of this study is to investigate whether a psycho-cognitive nursing intervention     including relaxation, guided imagery, touch and music listening can improve the clinical and     psychological outcome of critically ill patients. The investigators hypothesize that,     patients who receive the proposed psycho-cognitive nursing intervention will report lower     stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower     levels of inflammatory molecules, less complications and better self reported lived     experience than patients who receive standard care alone.   "
65890|NCT02423239|"     This study is a trial of dexanabinol in patients with advanced tumours. The purposes of the     protocol are to study different doses of the study drug to determine the maximum safe dose of     the drug given in combination with standard chemotherapies and to further understand the     safety of the study drug and to measure any reduction in size of patients' cancer tumour(s).      Dexanabinol is a synthetic cannabinoid which has previously undergone clinical trials for     traumatic brain injury (TBI) and in subjects undergoing coronary artery bypass surgery.     Currently dexanabinol is under investigation for potential anti-tumour activity in patients     with advanced tumours.   "
65891|NCT02423226|"     The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds     implant plus systemic chemotherapy for locally recurrent rectum cancer.   "
65920|NCT02422836|"     The subjects will use the test skincare products. This is a full face, twice daily     application study, with digital photos and expert grader evaluations at Baseline, 4 and 8     week periods. If the subject meets the study criteria and is enrolled, they will be     instructed at screening visit to discontinue the use of any facial products (except dry     mineral foundation and eye make-up) for seven (7) days before beginning the study (referred     to as the washout period). They will return to the site for the baseline visit 2 after the     required 7 day washout period (visit can occur within 1 week after screening visit).   "
65892|NCT02423213|"     Optical coherence tomography (OCT )provides high resolution information regarding the     anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view.     Much of this information is not able to be visualized by a clinician. Utilizing this     information during surgery will allow for the ophthalmic surgeons to better understand how     surgical procedures impact the anatomic structure of the eye.      In this study an OCT device that has been built into the microscope (rather than mounted on     the side or held in the surgeon's hand) and will be utilized to take images at various     milestones during surgery to assess feasibility and potential utility of this technology.     Since it is built into the microscope, there are potential significant advantages over a     separate system including increased efficiency, improved working distance, and the ability to     visualize tissue-instrument interactions.   "
65893|NCT02423200|"     This study will assess the effects of VX-745 on markers of disease in the central nervous     system of patients with MCI due to AD or with mild AD. The study will also evaluate the     safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the     plasma and cerebrospinal fluid concentrations of VX-745 during dosing.   "
65894|NCT02423187|"     To investigate the safety and efficacy of long-term combination therapy with rabeprazole and     low-dose aspirin.   "
65895|NCT02423174|"     The objective of the clinical trial is to determine the suitability of the FMwand     Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.   "
65896|NCT02423161|"     OCT provides high-resolution information regarding the anatomic structure of the tissues of     the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be     recognized by a clinician. Utilizing this information during surgery will allow for     ophthalmic surgeons to better understand how surgical procedures impact the anatomic     structure of the eye.   "
65897|NCT02423148|"     This research study is studying a new imaging method that will show lymph nodes in the lung     during lung cancer surgery. The name of the study intervention involved in this study is:      -- The combination of the FluoSCOPE device and Indocyanine Green   "
65898|NCT02423135|"     The aim of the proposed project is to perform a clinical study in which volunteers will     receive autologous blood transfusions in DEHP-free blood bags.   "
65899|NCT02423122|"     This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque     burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB     (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and     after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and     day 45.   "
65913|NCT02422927|"     The investigators tested if a nutraceutical combination with red yeast rice, berberine and     policosanol (NC) can significantly modify inflammation, lipid profile and markers of     endothelial injury (endothelial microparticles) in subjects with elevated levels of     high-sensitivity C-reactive protein (hsCRP).   "
65991|NCT02421913|"     Background: The use of low-dose continuous infusion of S(+)-ketamine combined with     target-controlled intravenous anesthesia with remifentanil and propofol may be related to the     control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to     evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the     control of postoperative pain compared to placebo.   "
65900|NCT02423096|"     Background: Schizophrenia is a serious mental illness. The diagnosis and severity evaluations     of schizophrenia are generally based on patient behaviors. Biomarkers are objectively     measured and used as indicators for diagnosis confirmation, symptom assessment, and     evaluation of pharmacologic responses to therapeutic interventions. Neuroendocrine and     metabolite substrates are potential biomarkers of the pathogenic processes in schizophrenia.      Aims: The aims of this study are to determine (a) the differences in neuroendocrine and     metabolite substrates between patients diagnosed with schizophrenia and healthy controls; and     (b) the associations among the neuroendocrine and metabolite substrates, cognitive function,     clinical symptoms, and treatment responses of patients diagnosed with schizophrenia.      Methods: (a) The investigators plan to recruit 100 patients diagnosed with schizophrenia and     100 healthy controls as participants. (b) At the baseline and Week 12, patient blood samples     will be obtained to measure the levels of neuroendocrine substrates and metabolite markers.     Clinical symptoms and cognitive function will be evaluated. (c) For the healthy control     participants, blood samples will be obtained once to measure neuroendocrine and metabolite     marker levels.      Expected Results: The results of this study may contribute to identifying potential     neuroendocrine and metabolite biomarkers of schizophrenia, and clarify the associations among     the neuroendocrine and metabolite substrates, cognitive function, clinical symptoms, and     treatment responses of patients diagnosed with schizophrenia. Such information is crucial for     clinical evaluations and future research.   "
65901|NCT02423083|"     Background:      - People with multiple sclerosis (MS) get lesions in their brain and spinal cord. These cause     neurological symptoms and sometimes disability. Researchers want to see if a blood pressure     drug called guanabenz can repair lesions and help people with MS.      Objective:      - To see if guanabenz is safe and well tolerated in people with MS.      Eligibility:      - People 18 55 years old with MS who have taken glatiramer acetate for the past year.      Design:        -  Participants will be screened in a separate protocol. For 2 months, they will be          examined and have magnetic resonance imaging (MRI) scans. This will decide if they are          in the Stable or Active MS study group.        -  The study will last 5 months. There will be up to 11 visits, 5 overnight.        -  Visit 1: overnight stay at the clinic:        -  Medical history and physical exam.        -  Health questionnaire        -  Bladder ultrasound scan        -  Brain MRI        -  Electrocardiogram (EKG) to measure heart electrical activity        -  Blood will be drawn through an intravenous (IV) line.        -  Participants may have tests of strength, muscle tone, and movement.        -  They will get their first dose of the study drug, a tablet taken once a day.        -  Participants will take the study drug at home and keep a medicine diary.        -  The dose will slowly increase. Each time, participants will stay overnight at the          clinic. They will have a physical exam, EKG, MRI, and IV blood draw.        -  Visit 6: Participants will have a physical exam, MRI, and blood drawn. They will get a          schedule to slowly lower their drug dose and stop taking guanabenz.        -  Participants will have 2 final visits. They will have a physical exam, EKG, MRI, and IV          blood draw.   "
65919|NCT02422849|"     the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to     hospital admissions in this age group. However hospital admission is linked to adverse     events. like confusion, medication errors or new infections.      the ACCESS project aims to examine alternatives to acute admissions for senior medical     patients.      the aims are:        1. How many patients will be admitted to hospital due to acute medical conditions if cared          for by their own General Practitioner (GP) versus a hospital intern specialist ?        2. how many patients will be admitted to hospital due to acute medical conditions if cared          for by acute team in their home versus in specialised care centres ?   "
65902|NCT02423070|"     Background:      - Some people with advanced heart and lung disease have heart and lung transplants. But the     organs are often rejected. When this happens, the organ recipients must have repeated     biopsies. These are invasive and expensive. Researchers want to see if a blood test can     predict rejection and take the place of biopsies. The test shows how much donor DNA is in a     recipient s blood.      Objective:      - To see if a new blood test can be used instead of biopsies to diagnose rejection after     transplant.      Eligibility:      - Adults 18 years and older who are on the lung or heart transplant waitlist.      Design:        -  Participants will have about 4 teaspoons of blood drawn from the arm before having their          transplant.        -  Researchers will collect demographic data about participants. They will also collect          basic medical information about their condition.        -  After surgery, while still in the hospital, participants will have 2 teaspoons of blood          drawn twice a week until they go home.        -  At each biopsy visit after the transplant, participants will have 4 teaspoons of blood          drawn for testing for up to 5 years.   "
65903|NCT02423057|"     Background:      - Genes are made up of DNA and are the instruction book for cells. When people have cancer,     some of the genes that might have slowed the growth of tumor cells were turned off.     Researchers think a drug called TdCyd might help to turn these genes back on. This may slow     the growth of tumors in people with cancer.      Objectives:      - To test the safety of TdCyd and to find out how it works. Also, to find out the dose of the     drug that can be safely given to humans.      Eligibility:      - Adults 18 years and older who have advanced cancer that has progressed after standard     treatment, or for which no effective therapy exists.      Design:        -  Participants will take TdCyd by mouth. The drug is given in 21-day cycles. TdCyd is          taken once a day during week 1 for 5 days. Then for 2 days participants do not take the          drug. Then they take it for 5 days during week 2. No TdCyd is taken during week 3.        -  Participants will keep a diary of their study drug doses.        -  Participants will have tests about every 3 weeks to see how the study drugs are          affecting their body. They will have blood and urine tests, a medical history, and          physical exams. They may have computed tomography (CT) scans to measure their tumors.          They may have an electrocardiogram, which measures the heart electrical activity.        -  If participants develop any side effects, they may be asked to visit more often.        -  Participants will stay in the study as long as they are tolerating TdCyd and their          tumors are either stable or getting better. One month after stopping the drug, they will          have a follow-up phone call.   "
66174|NCT02419534|"     To evaluate whether effectively treating anal fissure-associated constipation using oral PEG     alone can eliminate the inconvenience of add topical agent such as DTZ. As previous studies     have shown the topical agent are more effective in treating anal fissure when combined with     less effective laxatives   "
65904|NCT02423044|"     Background:      - Fear is a normal response to a threat. Learning fear can be helpful sometimes. For people     with anxiety disorders, fear can be long-lasting and too intense. Researchers want to study     how people become fearful of situations. They want to understand how the brain learns when it     is helpful to feel fear and when it is not.      Objective:      - To better understand brain processes related to fear and anxiety.      Eligibility:        -  Right-handed adults ages 18 50 with generalized anxiety disorder, panic disorder, social          anxiety disorder, or post-traumatic stress disorder.        -  Right handed volunteers ages 18-50 without psychiatric disorders.        -  And free of psychiatric medication for 2 weeks      Design:        -  Participants will first be screened under another protocol.        -  Participants will play a video game inside a magnetic resonance imaging (MRI) scanner.          The scanner is a metal cylinder It is surrounded by a strong magnetic field.          Participants will lie on a table that can slide in and out of the scanner. A device          called a coil will be placed over the head.        -  During the scan, participants may play a virtual reality video game. Game instructions          will be explained before they enter the scanner.        -  While playing the game, participants will wear 2 electrodes on their fingers. These          measure sweat on the skin. They will also have 2 small electrodes attached to the left          hand. These can give brief mild electrical shocks.        -  Participants will be asked questions when playing the game during the scan.        -  Before and after the scan, participants will fill out questionnaires about their          emotions. They may complete questionnaires online while at the clinic.   "
65905|NCT02423031|"     Background:      - Medical problems and treatments can cause stress in some people. Researchers want to learn     more about how to measure distress in young people with medical illnesses. A screening tool     called Checking In will be developed in order to help researchers find ways to identify     concerns and stresses common to this group.      Objective:      - To create a screening tool that will help health care providers identify psychological and     social distress in young people with serious illnesses.      Eligibility:      - Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time     of the study.      Design:        -  Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks          about mood, pain, fatigue, peer relationships, and sleep. During this phase,          participants will be asked about the wording of the questions in Checking In. They will          also talk about what they thought of the questions and if they understood them.        -  Phase 2 will not involve participant enrollment. During this phase the researchers will          be working with technologists to develop the software for an electronic version of          Checking In.        -  Phase 3 participants will complete an electronic version of Checking In. Researchers          will ask questions about the ease or difficulty of using an electronic screen.        -  Phase 4 participants and one of their caregivers will complete an electronic version of          Checking In. They will also complete other questionnaires related to mood, pain fatigue,          peer relationships and sleep. They will be asked their thoughts about using Checking In.          On the same day, their NIH doctor will get summary data about their questionnaire          answers. The doctor will also provide feedback about the summary form.        -  Researchers will compare data from Checking In with data from the other questionnaires.   "
65906|NCT02423018|"     The purpose of this study is to determine if a single dose of pregabalin 300mg in patients     receiving medications for sedative-hypnotic withdrawal symptoms will produce meaningful     differences in measures of drug liking and drug high as compared to placebo.   "
65907|NCT02423005|"     A prospective, randomised, controlled, single-blind, multi-site clinical study employing     Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women     suffering from stress urinary incontinence.      Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary     incontinence will be enrolled in this study. All patients who are considered eligible to     participate in the clinical study and give consent will be randomised to complete either a     12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment     programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will     be completed by the subjects at home with treatment with the device in accordance with the     device Instructions for Use.   "
65908|NCT02422992|"     This is a case/control epidemiology study to identify what are the iron-metabolism     abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD     predisposition.   "
66791|NCT02411487|"     To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland     dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular     surface parameters after cataract surgery according to the preoperative MGD grade.   "
65909|NCT02422979|"     This is a two-part clinical study of patients with recurrent Head and Neck Cancer (HNC), who     in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation     or platinum chemotherapy. The purpose of the study is to determine the safety and anti-cancer     activity of various doses and repeated cycles of the experimental treatment using the study     drug RM-1929 and fixed amounts of red light applied at the tumor site to activate the     pharmacodynamics of the drug.      The part 1 of the study has been completed and consisted in a single cycle, 3+3 dose     escalation safety study of the experimental drug RM-1929 using a fixed amount of 690 nm red     light. The part 1 was designed to determine the safety of the treatment as set by the maximal     feasible dose or the maximal tolerable dose of RM-1929. From the part 1 results, the maximal     feasible dose of RM-1929 was determined.      The part 2 of the study is currently ongoing and it is evaluating the safety and anticancer     efficacy of up to four repeated treatments of Photoimmunotherapy with RM-1929 at the maximal     feasible dose of RM-1929 activated with a fixed amount of red light.   "
65910|NCT02422966|"     The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to     ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.   "
65911|NCT02422953|"     Widespread food insecurity and malnutrition are largely the main impairing factors for human     capital development in Pakistan. Rates of chronic malnutrition are very high, and acute     malnutrition is critical: 44% of children under five are stunted and nationwide global acute     malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of     15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting     rates were at 36%.      This study evaluates the effectiveness of food based interventions to prevent stunting among     children under-five years with focus on window of opportunity (1000 days from conception to 2     years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months     will receive supplements on monthly basis in intervention areas, while participants in     control areas will receive routine public health services available in the study area.   "
65912|NCT02422940|"     This is an extension study to evaluate the long-term safety, tolerability, and efficacy of     two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12     months to subjects with chronic post-ischemic stroke walking deficits who have completed the     controlled, double-blind Study DALF-PS-1016.   "
65914|NCT02422914|"     Background. Smoking is considered a global public health problem. For this reason, the     smoking dependence was called by experts as a global epidemic.      Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been     an important expansion in many countries. Nevertheless, there is poor evidence that TFC are     beneficial for smoking cessation. In particular, even though it has been proved that the     nicotine replacement devices helps many individuals to give up smoking and to tolerate the     withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its     contribution in tobacco reduction. This protocol in particularly innovative, since it aims to     test the efficacy of electronic devices in a screening program (the lung cancer prevention     program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower     individual's risk.      Methods and Design. This experimental protocol has been designed with the main aim to     investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping     smokers to improve their lung health and to quit or reduce tobacco consuming. In particular,     the investigators aim at investigating clinical (physical symptoms, with particular focus on     breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked),     and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.      The investigators will also analyze, as a secondary aim, the psychological and lifestyle     component of smokers involved in order to fine correlation data that might be used to compute     a predictor index able to suggest the probability of success, with respect to the reduction     of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be     organized as a nested randomized controlled study with two arms: one experimental group and     one control group. The study will be nested in the screening program for lung cancer, where     subjects will be recruited.      All subjects will be entered in a psycho-cognitive low-intensity counseling program (6     months), but in the experimental group a TFC (with or without nicotine) will be used as     replacement device for three months, while in the control group only low-intensity counseling     will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity     tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical     activities.   "
65915|NCT02422901|"     The aim of this long-term observational study is the documentation of the use of PASCORBIN®     7.5 g in patients with vitamin C deficiency. Regarding the vitamin C deficiency, the     investigators focus on the acquisition of data of the underlying diseases and the reduction     of symptoms, that are related to oxidative stress and vitamin-C-deficiency. Next to this,     exact assessment of medical tolerance and details of treatment requirements are further aims.     Here the investigators take into account acute and chronic underlying medical conditions.     Further health economic data are collected.   "
65916|NCT02422888|"     The current trial will compare the protective effect of ticagrelor and prasugrel on     microvascular dysfunction in patients with revascularized ST elevation myocardial infarction.   "
65917|NCT02422875|"     The purpose of this study is to compare immune phenotype, function, and specificity of B     lymphocytes from different developmental stages in autoimmune patients to B cells from     infectious disease patients and healthy controls.   "
65918|NCT02422862|"     Frequently, headache is associated with disorders of the cervical spine, specially on the     upper cervical spine. Therefore, restoration of the upper cervical mobility is considered     fundamental for the treatment of headache.      Manual therapy interventions seek to restore upper cervical mobility through a wide range of     therapeutic procedures, including mobilization or manipulation techniques. Previous     systematic reviews reported preliminary evidence for the application of upper cervical manual     therapy techniques for the management of headache.      The objective of this study is to study the effects of upper cervical translatoric spinal     mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold in     subjects with headache. For this purpose, the investigators will conduct a randomized     controlled trial. Volunteers with headache will participate in the study and will be randomly     divided into control or treatment group. Treatment group will receive UC-TSM and the control     group will receive no treatment.      Headache intensity, cervical mobility, temporomandibular mobility and pressure pain     thresholds (PPT) will be measured before and immediately after each treatment session (3     treatment sessions in one week period) and after one month follow-up. At this moment, global     perceived effect will be assessed.   "
66859|NCT02410603|"     The purpose of this study is to explore the detection of circulating tumor DNA, soluble     immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).   "
65921|NCT02422823|"     Ninety patients with irreversible pulpitis diagnostic will participate in this clinical     study. The participants will be divided into 2 groups of 45 patients, who will receive the     inferior alveolar nerve block injections of 1.8 mL of 4% articaine (Articaine 100; DFL, Rio     de Janeiro, RJ, Brazil) with 1:100,000 epinephrine or 3.6mL of the same solution. Two     consecutive negative responses to the maximum pulp stimulus (80 µA) at the electric pulp test     were the criterion to determine a pulpal anesthesia as successful. Ten minutes after the IAN     block, subjective lip anesthesia will be evaluated by asking the patient whether his/her lip     was numb. Thereafter and immediately before the pulpectomy, the electric pulp stimulations     will be repeated to determine pulpal anesthesia. During the pulpectomy procedure, the     patients were instructed to report any painful discomfort. To evaluate the intensity of pain     during the pulpectomy, a verbal analogue scale will be used. The anesthesia will be defined     as successful when the dentist accessed the pulp chamber without pain being reported by the     patient. In these cases, the pulpectomy will be continued. If report pain will classified the     IAN block as unsuccessful.   "
65922|NCT02422810|"     The purpose of this study is to characterize a new test to assess the rate and time it takes     to form a blood clot in people who either do or do not take aspirin.   "
65923|NCT02422797|"     The aim of this study is to determine if virologically suppressed, human immunodeficiency     virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside     reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching     to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily     assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared     to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for     eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include     2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase     inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label     treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch     Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will     participate in the Early Switch Phase where they will either switch from their CAR to DTG +     RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible     participants will proceed to the Late Switch Phase where all participants in both DTG + RPV     and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148,     subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study     is planned to be conducted in approximately 476 participants.   "
65924|NCT02422784|"     This is a cross-sectional study designed to compare plasma/serum and urine vitamin D     metabolite profiles of vitamin D sufficient and insufficient individuals.      There are two phases of this study.      Phase 1 - Consented study participants will attend a screening visit and provide a fasting     blood and urine sample. Those individuals who are vitamin D insufficient based on serum     25(OH)D concentrations will be invited to participate in Phase II      Phase II - is a double-blind, randomized, control study designed to examine vitamin D status     in vitamin D insufficient individuals consuming a water-soluble form of vitamin D3. Eligible     participants will be asked to consume one of three beverages: i) rooibos iced-tea (control);     ii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3; or iii) rooibos     iced-tea fortified with 1000 IU of water-soluble vitamin D3 and 360 mg calcium at 240 mL of     iced-tea consumed daily for 6 weeks. Participants will attend 6 weekly visits following     baseline and provide a fasting blood sample for assessment of serum 25(OH)D concentrations.      Objectives: 1) To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin     D sufficient and insufficient individuals; and 2) To determine the effects of vitamin D3     fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations, markers of vitamin D     and calcium metabolism, and vitamin D metabolite profile in plasma/serum and urine of vitamin     D insufficient individuals.   "
65925|NCT02422771|"     In response to high injury rates in soccer, the Fédération Internationale de Football     Association (FIFA) developed an injury prevention program called the 11+. It is designed to     replace a standard warm-up and takes about 20 minutes to complete. The program has proven     remarkably effective in decreasing the rate of injury in soccer players. However, uptake of     the 11+ has been less than desired. Adoption of the program may be increased if additional     benefits can be demonstrated and the program is introduced at a younger age. The goals of     this study are to (1)establish that young athletes can tolerate the program, and (2)measure     the effects of the 11+ program on the physical performance of 10-12 year old girls. Three     teams will be randomly assigned to the intervention group and carry out the 11+ program for     the duration of the indoor soccer season. Another 3 teams will continue with their usual     warm-up. Pre- and post-intervention, balance, agility, core strength and movement control     will be assessed in all athletes. The investigators hypothesize that the athletes will     tolerate the program well and that the intervention group will improve on the performance     tests significantly more than the control group.   "
65926|NCT02422758|"     Perioperative hypothermia brings numerous and recognized postoperative complications. Active     warming intraoperatively helps to maintain body temperature in the postoperative period, but     there are few studies in Brazil, assessing the effect of prewarming in maintaining     normothermia. It is believed that prewarming with forced air warming system keep the body     temperature during intra and post-operative. This study aims to evaluate the effect on     prewarming maintaining body temperature of patients undergoing elective surgery of Gynecology     specialty using the forced air warming system. The study is experimental design, controlled     type randomized clinical trial, with simple blinding for patients. Eighty adult patients     undergoing gynecological surgery in the art, with a surgical time of at least an hour will be     randomized and allocated into experimental groups - prewarming system with forced air warming     system for 20 minutes, and control - Prewarming with sheet and blanket for 20 minutes. The     patients will be kept warm during the anesthetic-surgical procedure. The measurement of     temperature will be using a tympanic thermometer. Participants will be followed from     receiving the surgical center to the end of surgery. Data will be recorded in validated     instrument. Data analysis will be used the Model Linear Mixed Effects and the Structure Error     Auto-Regressive.   "
66904|NCT02410018|"     This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of     uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for     hysterectomy.   "
65927|NCT02422745|"     The purpose of this study is to determine whether taking daily, dietary supplements of cocoa     extract (containing cocoa flavanols and theobromine from the cocoa bean) and/or a standard     multivitamin reduces the risk of developing cardiovascular disease (including heart attack,     stroke, coronary revascularization, and cardiovascular mortality) and cancer.   "
65928|NCT02422732|"     A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in     children with NF1 with or without reading disabilities.   "
65929|NCT02422719|"     The purpose of this study is to determine whether radotinib is effective and safe for     patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to     prior 2 or more tyrosine kinase inhibitors.   "
65930|NCT02422706|"     Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor     (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one     of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used     instead of Amoxicillin or Clarithromycin in cases of allergy or resistance .      However, a recent study based on the Maastricht III guidelines, indicated that treatment with     a PPI-based triple regimen as first-line therapy will fail in ~30% of patients on an     intention-to-treat (ITT) basis, and will fail in ~ 50 % of patients who treated with     PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue     warranting the investigation of other agents. Helicobacter pylori infection has become     increasingly resistant to traditional first-line treatment regimens because of emerging     antibiotic resistance coupled with poor patient compliance with completing the treatment     course that decrease H. pylori eradication rates. So there is a considerable interest in     evaluating new antibiotic combinations and regimens .   "
65931|NCT02422693|"     The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic     exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain     in patients with specific chronic low back pain.   "
65948|NCT02422472|"     The purpose of this study is to compare ultrasound guided peripheral IV placement with and     without the use of a guidewire. Patients in the Emergency Department with difficult     peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and     randomized to standard ultrasound guided peripheral IV placement or ultrasound guided     peripheral IV placement with modified seldinger technique using a guidewire.   "
65949|NCT02422459|"     The purpose of this study is to determine whether the combination of self-management support,     pain science education, and individualized, goal-oriented exercises helps people with chronic     pain to increase their function.   "
65932|NCT02422680|"     The study aim to capture key quality indicators and patient satisfaction for at least 500     patients referred for a colonoscopy at Aalborg University Hospital. The patient population is     mix of screening and non-screening colonoscopies seen at our out-patient clinic.      Each Colonoscopy is registered using a specially designed registration form and a more     detailed form relating to the colonoscopy itself. The data collected includes: Endoscopy     experience and education, Medicine use, Colonoscopy duration, Caecum Intubations rate and     documentation, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse assisted     Gloucester Comfort score. Each patient were given a questionaire with 6 questions answering     satisfaction, pain, discomfort etc on a 10 cm analog scale.   "
65933|NCT02422667|"     The goal of this registry is to review the data collected and research ways to improve     patient safety, quality of care, and medical decision-making, reduce medical spending, and     help advance orthopedic science and bioengineering.   "
65934|NCT02422654|"     Primary Objective:      The purpose of this study is to assess the palatability of eliglustat prototype liquid     formulations in healthy subjects.   "
65935|NCT02422641|"     Management of leptomeningeal disease (LMD) in patients with metastatic breast cancer is an     area of unmet clinical need. High-dose methotrexate (HD-MTX) is known to have activity     against breast cancer and in contrast to other systemic chemotherapeutics, it penetrates the     blood brain barrier, targets areas of poor cerebrospinal fluid flow, may penetrate bulky     leptomeningeal disease, and provide treatment to systemic disease burden. While two     retrospective studies have suggested activity of HD-MTX in LMD in patients with breast     cancer, no prospective data are available to inform its inclusion in treatment regimens.     Thus, while HD-MTX is included in the NCCN Guidelines for LMD and while it is used to varying     degrees in cancer centers across the nation, this is more representative of the lack of     available therapies for LMD as opposed to strong evidence-based data. This phase II,     prospective study will evaluate systemic, intravenous HD-MTX in breast cancer patients with     leptomeningeal metastasis with or without brain parenchymal metastasis.   "
65936|NCT02422628|"     Correlation of epithelial growth factor receptor mutation in blood of lung cancer patient and     clinical outcome.   "
65937|NCT02422615|"     This is a multi-center, randomized, double-blinded, placebo controlled trial in men and     post-menopausal women with advanced breast cancer.   "
65938|NCT02422602|"     This study is multicentric, single-blind, and interventionnal with a randomization into two     parallel arm, between a standard of care information and an additionnal information of the     patient, with a 12 month follow up.      The aim of this study is to evaluate the effectiveness of a personalized information programm     versus information provided from standard of care in patients taking Xarelto for Stroke     Prevention in Atrial Fibrillation.   "
65939|NCT02422589|"     The purpose of this study is to evaluate the potential inhibitory effects of ceritinib on the     CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin,     respectively, when administered simultaneously as a cocktail. The results obtained from this     drug interaction study will provide guidance that will enable an update to the ceritinib     labeling and will help guide recommendations for administration of co-medications in future     clinical trials.   "
65940|NCT02422576|"     Assessment of the improvement of the safety of the swallowing function under 3 natural     ingredients known to be agonist of sensory receptors.   "
65941|NCT02422563|"     Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with     pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in     patients with cervical cancer FIGO IB2 and IIB.   "
65942|NCT02422550|"     Magnetic resonance imaging (MRI) is currently one of the standard diagnostic imaging methods     used to diagnose tumor stage before treatment in Radiology Oncology Department. It is also     used to check responses to radiation after treatment. However, MRI isn't traditionally used     in planning for radiation treatment or in checking treated tumor and tissue changes during     radiation treatment. The goal is to find out the possible benefits of MRI imaging techniques     in these settings of radiation treatment. Participating in this study would NOT change the     current treatment plans, this will allow the investigators to use the MRI methods in research     and future patient care.   "
65943|NCT02422537|"     During this project the effect of 3 different bran-based dietary platforms on the     fermentation on a readily fermentable substrate will be investigated using stable isotope     techniques.   "
65944|NCT02422524|"     This is a Phase 1, single dose, open-label, sequential group study comparing the     pharmacokinetics and safety of PA-824 in subjects with mild, moderate, and severe hepatic     impairment to matched, non-hepatically impaired subjects. Primary objective: To evaluate the     pharmacokinetics of a single oral dose of PA-824 in subjects with mild, moderate, and severe     hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically     impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of     PA-824 in subjects with mild, moderate, and severe hepatic impairment (as assessed by     Child-Pugh score), relative to matched non-hepatically impaired subjects.   "
65945|NCT02422511|"     The Genomic Sequencing for Childhood Risk and Newborn Illness (the BabySeq Project) is a     research study exploring the use of genomic sequencing in newborns. The National Institutes     of Health is funding this study.      The investigators will enroll 240 healthy infants and their parents from the Brigham and     Women's Hospital (BWH) Well Newborn Nursery and 240 sick infants and their parents at Boston     Children's Hospital (BCH) or the BWH Neonatal Intensive Care Unit (NICU). A small blood     sample will be collected from each infant and genome sequencing may be performed. Six weeks     later, results are returned and explained. Over 12 months the investigators are studying the     experiences of parents and pediatricians of infants who receive sequencing to help understand     how best to use genomics in pediatric care.   "
65946|NCT02422498|"     The study is being done to find out if the results of a pre-treatment biopsy can predict     response to cisplatin and radiation treatment for patients with metastatic or recurrent     triple negative breast cancer.   "
65947|NCT02422485|"     This is a multi-center, open label, pilot futility clinical trial of the safety,     tolerability, pharmacodynamics and preliminary efficacy of oral salsalate in up to 10     patients with PSP.   "
65952|NCT02422420|"     The objective of this study is to test whether two different participant financial incentive     structures are more effective and cost effective than minimal financial incentives in     increasing weight loss among Minnesota Medicaid beneficiaries at high risk of developing     diabetes. The incentives are tied to participation and weight loss in the evidence-based     group-delivered YMCA diabetes prevention program (Y-DPP). The Investigators will conduct a     group randomized trial that includes up to 150 Y-DPP classes of 10-15 participants per class     for up to 1500 Medicaid beneficiaries participating in the Y-DPP classes. This approach, if     successful, will (a) improve weight loss. diabetes risk, and improve cardiovascular risk     among Medicaid beneficiaries at risk for developing diabetes and other chronic conditions,     (b) demonstrate that prevention of chronic disease risk factors using patient incentives is     cost-effective, and (c) provide a patient incentive model that can be widely used among     Medicaid beneficiaries at risk for developing diabetes.   "
65953|NCT02422407|"     The main objective of the study is to characterize the gene expression in immune and     epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's     syndrome) and non-pSS participants including healthy volunteers.   "
65954|NCT02422394|"     Inherited thrombocytopenias are a heterogeneous group of disorders characterized by a reduced     number of blood platelets and a consequent bleeding tendency that ranges from mild to     life-threatening. Thrombocytopenia is caused by genetic mutations and therefore is present     throughout patients' life and can be transmitted to the progeny. Some patients with severely     reduced platelet count present spontaneous bleedings, which represent a major clinical     problem: in fact, bleeding diathesis exposes these subjects to the risk of severe     hemorrhages, affects their quality of life and often requires hospitalization and/or     transfusions. Conversely, other patients with inherited thrombocytopenias have absent or mild     spontaneous bleeding tendency. However, even these patients are at risk of major bleedings on     the occasion of surgery or other invasive procedures. Therefore, the potential for     hemorrhages on the occasion of invasive procedures represent a clinical problem for all     patients affected by inherited thrombocytopenias.      Eltrombopag is a drug, available in tablets, which stimulates the production of platelets by     the bone marrow. A previous study demonstrated that a short course of eltrombopag was     effective in increasing platelet count in most patients with the MYH9-related disease     (MYH9-RD), one form of inherited thrombocytopenia. Eltrombopag was given for 3 to 6 weeks to     12 patients with MYH9-RD and platelet counts lower than 50 x10e9/L. Eleven patients responded     to the drug and 8 of them obtained platelet counts higher than 100 x109/L or three times the     baseline value. Remission of spontaneous bleeding was achieved by 8 of 10 patients and     treatment was well tolerated in all the cases. Based on these findings, short-term     eltrombopag courses have been successfully used for preparing for major surgery two patients     with MYH9-RD and less than 20 x10e9 platelets/L.      The present study has two main objectives.      - To verify if eltrombopag is effective in transiently increasing platelet count over 100 x     109/L and abolish bleeding tendency in patients with different forms of inherited     thrombocytopenia.      To this end, eltrombopag will be given for 3-6 weeks to patients with different forms of     inherited thrombocytopenia. Eltrombopag will be administered at the dosage of 50 mg/day for 3     weeks. After 3 weeks of treatment, the patients who will obtain a platelet count higher than     100 x10e9/L will stop therapy. The patients who will achieve a platelet count lower than 100     x10e9/L will be treated with eltrombopag at a higher dosage (75 mg/day) for 3 additional     weeks. This treatment schedule is called Phase 1 of the study.      If the study will achieve this goal, short-term eltrombopag could be potentially used in the     future to prepare these patients for surgery or other invasive procedures      - To verify if eltrombopag can be used to stably reduce spontaneous bleeding tendency for     long periods of time in patients with clinically significant spontaneous bleedings.      To this end, patients with clinically significant spontaneous bleedings and who had their     bleeding tendency reduced during the Phase 1 of the study without severe side effects, will     be admitted to the Phase 2 of the study. During the Phase 2, patients will be treated with     eltrombopag for 16 weeks. In order to determine the lowest dose of eltrombopag that is able     to reduce or abolish their bleeding tendency, patients will start treatment with eltrombopag     25 mg/day for 4 weeks. Then, every 4 weeks, patients will be re-evaluated and the dosage of     eltrombopag will be adjusted according to the bleeding tendency of the 7 days before     evaluation. The dosages of eltrombopag that can be used in the Phase 2 range from 12.5 to 75     mg/day.      Other objectives of the study are:        -  to evaluate safety and tolerability of Eltrombopag in patients with inherited          thrombocytopenias.        -  to identify the dosages of Eltrombopag required to obtain the objectives of Phases 1 and          2.        -  to study the effect of treatment on some laboratory parameters related to platelet          production and function.      All patients will be undergo a follow-up visit 30 days after completion of treatment.      Patients will be treated as outpatients.      The evaluation of patients at enrollment includes: medical history; physical examination;     peripheral blood examinations to count blood cells, to examine blood cells by microscope, to     measure some parameters related to liver/kidney function and platelet production; standard     urine analysis; ophthalmic assessment. Studies for dose adjustment includes the same     examinations performed at enrollment with the exception of ophthalmic assessment. Evaluation     of patients at the end of the Phases 1 or 2 and 30 days after the end of treatment includes     the same examinations performed at enrollment: moreover, in patients who will obtain a     platelet count higher than 100 x10e9/L, the in vitro platelet function will be studied.   "
65955|NCT02422381|"     This is a study for patients with previously-treated advanced non-small cell lung cancer     (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to     standard treatment with gemcitabine. The study will also try to identify the best dose of     MK-3475 to give in combination with gemcitabine.   "
65956|NCT02422368|"     ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized,     triple masked, clinical trial of a selected combination of vitamins and minerals versus     placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm     design.   "
65957|NCT02422355|"     In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by     the competent authorities (CE mark). It is designated to stabilize medial femoral neck     fractures in a minimal invasive technique. The implant combines an angular stable device with     screw in screw technology for rotational stability. Therefore the purpose of this focused     registry is to investigate how the newly developed and approved implant called FNS is     performing clinically and radiologically in terms of surgical technique, intra- and     postoperative complications and short term outcome.   "
65958|NCT02422342|"     The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure     and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter.     The validation will be done by comparing the generated information to data gathered while     performing Stress Echocardiography. The first phase of the study will be done on 10 patients     undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital   "
65959|NCT02422329|"     The goal of this research study is to learn how patients' think about constipation before and     after receiving education about the subject.   "
65983|NCT02422017|"     Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their     management. At the origin of high health costs and strong repercussions on quality of life     for patients, they require long management and may be subject to possible complications.      In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks.      Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The     purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous     ulcers with topical timolol.   "
65960|NCT02422316|"     Background:      Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will     have Acute Myocardial Infarction. However, several studies indicate that patients where ACS     had been excluded by conventional methods sustain a higher cardiac morbidity and mortality     than the background population. Not all of these patients can be identified by traditional     risk factors such as cholesterol, hypertension, and diabetes or with conventional methods     such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of     calcification in the coronary arteries and might be a useful addition in predicting future     cardiac events in this patient group. The aim of this study is through a double-blinded study     to determine whether non-contrast CT scan with calcium score can be used to identify patients     at increased risk of death and cardiac event within the following 12 months after an acute     admission where troponin measurements were normal.      Methods:      The study will investigate patients with suspected Acute Coronary syndrome who have been     examined and subsequently sent home from an emergency- or cardiology department without ACS     or another obvious explanation. 750 patients, age 30-70 years who are included in the study:     Identification of risk factors in non-cardiac chest pain patients will be offered a     non-contrast CT scan with calcium score within 14 days after the hospital contact. The     participants will be included in a 12 months follow up, where the result of the calcium score     is not revealed neither for the patient nor the investigator. After 12 months the results of     the scan is compared with the rate of cardiac events. This project is a multicenter study and     recruits patients from 6 emergency - and cardiology departments in the region of Southern     Denmark.      The study commences at September 2014 and results of this project are expected to contribute     to the risk stratification of Non-cardiac chest pain patients.   "
65961|NCT02422303|"     Ketamine has been shown to have an antidepressant effect when given intravenously in doses of     2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known     in this instance to decrease postoperative pain. No one has studied whether or not ketamine     when given in doses used during general anesthesia (0.5mg/kg intravenous) has an     antidepressant effect on surgical patients who suffer from depression. The study is designed     to determine whether or not a small dose of ketamine when given at the induction of     anesthesia could have an antidepressant effect on surgical patients with depression.   "
65962|NCT02422290|"     This pilot study is proposed to determine the acceptability, feasibility and potential     efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid     treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults     with OCD. This study will recruit 6 youth (ages 14-22) who are diagnosed with clinically     significant OCD and have failed at least one adequate trial of a Serotonin Reuptake Inhibitor     (SRI) medication and a course of Cognitive-Behavioral Therapy (CBT) (unless unable to access     or tolerate) for OCD in the past. Participants will receive a single infusion of intravenous     ketamine and be assessed at regular intervals post-infusion for up to 14 days. At the end of     the 14-day treatment phase, all participants will be offered three months of open treatment     for OCD with medication and/or CBT.   "
65963|NCT02422277|"     The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock     wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.   "
66175|NCT02419521|"     The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native     coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.   "
65965|NCT02422251|"     The aim of the project is to compare the biomechanics of three different bearing designs used     in total knee replacement (TKR) implants. The bearing is the part in the middle of the knee     implant that allows the metal tray attached to the shin bone (tibia) to move in relation to     the metal part attached to the thigh bone (femur) and is usually made of plastic (high     density polyethylene). There will be three different bearing types in the study, which all     give different movements. This study will see which bearing is most like a natural knee and     so which design gives the best function and feeling to patients with a TKR. 90 TKR patients     from the Golden Jubilee National Hospital will be recruited and randomised to receive one of     the three study bearings (30 in each group). In addition, a control group of 30 healthy     individuals of similar age will be recruited for comparison. Before surgery and at 4 to 8     weeks and 1 year after their operation patients will attend biomechanical assessment sessions     at the University of Strathclyde. The control group will attend the assessment session only     once. In each of these sessions they will carry out a number of everyday tasks such as     walking, moving from sitting to standing and going up and down stairs. These tasks will be     measured using motion capture techniques. Reflective markers placed on each participant will     be tracked by cameras so that their movements can be recorded. Force plates in the floor will     record the forces during the tasks.      Movement and force data will be analysed to see if any differences exist between the groups     and show which bearing gives the most natural movement.   "
65966|NCT02422238|"     The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with     proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the     development of NASH in patients with simple steatosis and to identify and validate     non-invasive markers for the diagnosis of NASH.   "
65967|NCT02422225|"     The primary objective of this study is to investigate whether the dual transcranial direct     current stimulation(tDCS) improves the swallowing function of stroke patients.   "
65968|NCT02422212|"     Introduction: According to the National Health and Nutrition Examination Survey 2009-2010, 78     million American adults are obese. Bariatric surgery can provide for a sustained long-term     weight loss and the metabolic change caused by the surgery seems to be the main cause of this     loss. Cross-sectional, prospective and experimental studies, carried out during the     post-operative period of Roux-en-Y Gastric Bypass surgery (RYGBP) have shown an increase of     over 200% in energy expenditure after meals Diet-induced Thermogenesis (DIT), a specific     component of energy expenditure) when compared with obese patients. However, despite this     metabolic improvement, 20-50% of the patients can suffer weight regain about 2 years after     surgery. So one question whether such metabolic benefits remain active following     post-operative weight regain, or if the disappearance or decrease of these metabolic benefits     may be seen as causes of this weight regain.      Objective:To evaluate whether there are DIT differences between patients who maintained     weight loss and those who regained weight in the late postoperative (postop) period of RYGBP     and those who continue with preoperative (preop) obesity.   "
66003|NCT02421757|"     This is a single-site, randomized, Single-blinded, placebo-controlled, trial of     Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will be     applied locally to the back in the location of a patient's pain.   "
65969|NCT02422199|"     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This     study is a randomized, multi-center, multinational, open-label, active-controlled, parallel     design study of the combination of pyrotinib plus capecitabine versus the combination of     lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin,     taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab     and randomized in a 1:1 ratio to one of the following treatment arms:        -  Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)        -  Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients          will receive either arm of therapy until the occurrence of death, disease progression,          unacceptable toxicity, or other specified withdrawal criterion.   "
65970|NCT02422186|"     The purpose of this study is to evaluate the efficacy and safety of switching elderly     participants with treatment-resistant depression (TRD) from a prior antidepressant treatment     (to which they have not responded) to either intranasal esketamine plus a new oral     antidepressant or switching to a new oral antidepressant plus intranasal placebo.   "
65971|NCT02422173|"     Transcranial direct current stimulation (tDCS) has shown promising results in the modulation     of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose     of this study was to compare the effectiveness of three different montages of tDCS (anodal,     cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in     acute stroke patients.   "
65972|NCT02422160|"     The investigators have developed an image analysis method that can predict the likelihood     that a patient with age related macular degeneration (AMD) will progress within 1 year, based     on computerized analysis of optical coherence tomography (OCT) images that are routinely     acquired in clinical practice on each patient visit to the ophthalmologist. The     investigators' goal is to evaluate whether this method will improve the ability to detect AMD     earlier and improve visual outcomes in AMD patients by assigning patient risk categories and     having patients come back for follow up based on those categories.   "
65973|NCT02422147|"     This is a registry that will maintain prospective data on the clinical outcomes of all     patients with pancreatic cyst lesions who undergo EUS-guided alcohol ablation.   "
65974|NCT02422134|"     It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been     found naturally in reproductive tract so our target is to test its effect if added to embryo     transfer medium.   "
65975|NCT02422121|"     The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1     will be measured after an inhaled allergen challenge at baseline and again after 21 days of     treatment.   "
65992|NCT02421900|"     The purpose of this study is 1) to characterize T-cell response in patients with atrial     fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency catheter     ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling of T cells     from patients with atrial fibrillation will performed. Next the difference of T-cell immunity     among various type of atrial fibrillation patients will be analyzed. Finally the changes of     T-cell response and cytokines after radio-frequency catheter ablation of atrial fibrillation     will be assessed.   "
65976|NCT02422108|"     The receptor activator of NF-kB ligand (RANKL) system is considered important for bone     homeostasis and comprises three important factors. RANKL exist in three isoforms but the     predominant function is mediated by the transmembrane ligand that binds to a specific     receptor (receptor activator of NF-KB (RANK)) on a neighbour cell that subsequently activates     NFKB and regulates cell cycle OPG is an endogenous secreted protein that binds RANKL and     inhibits its signalling.      Thus, the RANK/RANKL system is vital for activation of the bone resorbing cells     (osteoclasts). In bone the bone synthesizing cells (osteoblasts) express RANKL that signals     to RANK on the immature osteoclasts. This induces proliferation and activation of the cells     they start to proliferate and resorp bone. OPG is produced by somatic cells in the bone and     this production is regulated by sex hormones, TGF-B and various other substances. Today a     human made recombinant antibody against RANKL, Denosumab is used to treat osteoporosis as it     inhibits RANKL signalling and thus causes less bone resorption in humans.      RANKL, RANK and OPG are expressed in the testis and this pathway appears to be a novel     regulator of germ cell proliferation. Decreased semen quality is a major factor of male     infertility. Semen quality is a measure of the ability of the sperm to accomplish     fertilization. Evaluation of male fertility potential is today basically conducted through     semen analysis. There is no treatment for men with no sperm in the ejaculate and there exist     no drug that can increase sperm counts.Therefore, drugs that can lower RANKL     expression/activity for instance an antibody against RANKL such as Denosumab may be used for     this new indication: A new treatment option of infertile men with impaired semen quality.   "
65977|NCT02422095|"     This registry is developed to assess the outcomes of patients undergoing EUS of pancreatic     cyst lesions as is provides data that will enable quality control of the examination     performed.   "
65978|NCT02422082|"     Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has     probiotic, health-promoting effects in both adults and children, and is safe for human     consumption. Animal models indicate that treatment with L. reuteri has positive effects on     bone metabolism and bone density. In other animal models of diabetes and the metabolic     syndrome, positive effects on blood glucose and weight have been reported. The present     double-blind, placebo-controlled, randomized study is designed to investigate if dietary     supplementation with L. reuteri twice daily for 12 months has any effect on bone density,     body composition, inflammation, or metabolic and endocrine markers in elderly women with     osteopenia.   "
65979|NCT02422069|"     This observational study will provide an opportunity to document local patterns of     susceptibility, patient profile, and usefulness of screening in postmenopausal patients     coming to gynecology outpatient clinics in Pakistan. This will also capture the initial     management of PMO in diagnosed patients. The information gathered will serve as a foundation     for developing national guidelines on screening and management of PMO in Pakistan.   "
65980|NCT02422056|"     Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding     in palatoplasty.   "
65981|NCT02422043|"     The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to     make the teenager to self manage their disease and its treatment. Based on social cognitive     theory Bandura, the effects of educational activities for TVE should lead to the     strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence     of teenager and a better quality of life. However, socio-cognitive determinants and     mechanisms to achieve this, implemented by adolescents during and after the ETP program, are     not sufficiently documented.   "
65982|NCT02422030|"     The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin     and Fenofibric acid.   "
65984|NCT02422004|"     The overall aim of this project is to investigate the healing processes of human tendon after     suturing a ruptured Achilles tendon, and more specifically to determine the optimal loading     pattern of the tendon during the rehabilitation period to ensure complete and good recovery     of tendon structure and function. The investigators hypothesize that restricting early weight     bearing and only allowing for passive stretching in the early phase of tendon healing will     ensure better tissue regeneration and thereby prevent chronic tendon elongation and improve     tendon tissue recovery and the clinical outcome.   "
65985|NCT02421991|"     The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT)     implementation outcomes are at least as good as those of traditional cognitive behavioral     therapy (CBT).   "
65986|NCT02421978|"     The purpose of this study is to try and provide data linking the impact of increased     inflammatory cytokines as a result of chemotherapy and their relationship with increased     levels of CNS glutamate and related behavioral and cognitive consequences in breast cancer     patients. The investigators will use neuropsychiatric assessments, blood sampling and     Magnetic Resonance Spectroscopy (MRS) to collect study data.   "
65987|NCT02421965|"     The study is a three year research project whose aims are to evaluate the willingness of     individuals with serious mental illness to initiate the two illness self-management     interventions- WRAP or FOCUS, to examine and compare participant engagement, satisfaction,     and outcomes (symptoms, recovery, quality of life) in the two interventions.   "
65988|NCT02421952|"     Pediatric research in the management of nausea has been limited by the absence of a reliable     method to quantify the intensity of this subjective symptom. In adults, the visual analog     scale (VAS) is an accurate tool, but this has not been shown to be reliable in young     children. By default the most common objective outcome measure used in pediatric studies has     been the incidence and number of emetic episodes. This measure, however, correlates poorly     with the somatic subjective symptom of nausea.   "
65989|NCT02421939|"     The purpose of this study is to determine the clinical benefit of ASP2215 therapy in patients     with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory     to or have relapsed after first-line AML therapy as shown with overall survival compared to     salvage chemotherapy.      This study will also determine the overall efficacy in event-free survival (EFS) and complete     remission (CR) rate of ASP2215 compared to salvage chemotherapy.   "
65990|NCT02421926|"     This study is an extension study (prospective observational study) of 'IDEAL' study (A Study     to Evaluate Efficacy and Safety of Imatinib (Glinib) 600mg/day depending on Early Molecular     Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase,     NCT02204722) to evaluate the duration of treatment response, disease progression, and     survival status up to 5 years after the inclusion.   "
65993|NCT02421887|"     The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether     treatment of infertile males with an antioxidant formulation improves male fertility. The     central hypothesis is that treatment of infertile males with antioxidants will improve sperm     structure and function, resulting in higher fertilization rates and improved embryo     development, leading to higher pregnancy and live birth rates. Findings from this research     will be significant in that they will likely lead to an effective, non-hormonal treatment     modality for male infertility. An effective treatment for men would also reduce the treatment     burden on the female partner, lower costs, and provide effective alternatives to couples with     religious or ethical contraindications to ART (Assisted Reproductive Technology). If     antioxidants do not improve pregnancy rates, but do improve sperm motility and DNA integrity,     they could allow for couples with male factor infertility to use less intensive therapies     such as intrauterine insemination. Male fertility specialists currently prescribe     antioxidants based on the limited data supporting their use. A negative finding, lack of any     benefit, would also alter current treatment of infertile males.   "
65994|NCT02421874|"     The purpose of this Phase II Small Business Technology Transfer (STTR) project is to complete     development and evaluate usability and effectiveness of the Wraparound Team Monitoring System     (Wrap-TMS), a web-based, electronic behavioral health information system (EBHIS) for the most     widely implemented care coordination model in children's behavioral health, the wraparound     process. Though wraparound is now considered evidence-based, implementation in the real     world often fails to conform to standards of fidelity and/or use objective data to guide     management, supervision, and clinical decision making. Availability of such a system will     support efficiency, implementation quality and fidelity, and outcomes for youths enrolled in     wraparound. Wrap-TMS features functionality for data entry, management, and basic reporting     for the full array of data and information elements needed to manage an integrated care     coordination initiative for youths with serious emotional and behavioral disorder (SEBD). In     light of our success in Phase I, subsequent partnerships with federal agencies, and inquiries     of interest from several states and over 20 provider and managed care organizations, in this     Phase II STTR the investigators will complete development of Wrap-TMS, followed by a     randomized controlled effectiveness study comparing n=25 wraparound facilitators who use     Wrap-TMS serving n=100 families to 25 non-user facilitators serving 100 families on     practitioner, implementation, and youth/family outcomes. The evaluation will test two primary     hypotheses:        1. Compared to facilitators in the control group, wraparound facilitators trained to use          Wrap-TMS will demonstrate (a) greater use of data and feedback in service delivery; (b)          greater fidelity to the wraparound process; (c) higher self-reported teamwork, working          alliance, and satisfaction with the intervention; and (d) more positive attitudes toward          standardized assessment.        2. Compared to the control group, parents of youths receiving services from facilitators          trained to use TMS will report (a) greater goal clarity, (b) more data collection and          use (c) greater satisfaction with services and progress, (d) better fidelity to          wraparound, (e) more effective team functioning, (f) greater treatment alliance, and (f)          better youth outcomes including greater progress and improved symptoms and functioning.   "
66063|NCT02420977|"     This research is being done to see if an investigational radioactive imaging agent     (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the     prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer     before surgery.   "
65995|NCT02421861|"     The aims of this study are to (1) test the benefits of a non-pharmacologic anxiety management     approach with patients who are critically ill and/or traumatically injured during intensive     care hospitalization and (2) test whether this approach reduces anxiety and improves     engagement in rehabilitation therapies, shortens duration of hospitalization, and improves     psychological and quality of life outcomes.   "
65996|NCT02421848|"     Malnutrition due to liver disease is common, however, their detection is difficult. The     parameters used for nutritional assessment in clinical practice have limited use in this     patient population.      From this perspective, this study proposes to develop predictive equations for body     composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and     risk free, the BIA offers the additional advantage of low cost compared to other methods that     assess body composition (BC).      Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic     of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo.      This pioneering study is of great clinical importance because malnutrition is a relevant     factor in the prognosis of liver disease and there is not efficient method in clinical     practice to properly assess the body composition in this population.   "
65997|NCT02421835|"     Hypertension affects about 30% of the United Kingdom population and is causally implicated in     the aetiology of renal disease, cardiovascular disease and stroke. Ageing, obesity, a poor     diet and low levels of physical activity are all risk factors. Studies have shown that     adherence to a Mediterranean diet is protective against hypertension and its associated     morbidities; olive oil is believed to be a key beneficially bioactive component of that diet.     As a source of lipids olive oil is an unremarkable blend of monounsaturated, polyunsaturated     and saturated fatty acids; it is however rich in phenolic compounds, principally oleuropein     and hydroxytyrosol, which may be of benefit to health. A recent randomised intervention trial     in predominantly hypertensive volunteers showed that adherence to a Mediterranean diet     supplemented with extra virgin olive oil, reduced blood pressure and other measures of     cardiovascular disease risk. Olive phenolics can be extracted cheaply from the waste products     of olive oil manufacture, such as the plant leaf and these are used as dietary supplements.     In intervention studies in hypertensive or borderline hypertensive patients, olive leaf     extract consumption has been shown to reduce blood pressure.      Another intervention with established efficacy for improving blood pressure is to increase     physical activity. The 'Start Active, Stay Active', Chief Medical Officers report on physical     activity recommends that adults achieve 150 minutes of moderate intensity physical activity     per week, while data in that report suggest that fewer than 40% of adult men and 30% of adult     women achieve these targets. Adherence to the physical activity guidelines may in fact be     much worse in sub-sections of the population at higher risk of hypertension.      From a public health perspective, holistic guidelines for the prevention of hypertension, or     its early diagnosis and management, based around a healthy diet and lifestyle are preferable     to pharmaceutical intervention. Lifestyle interventions are economically favourable and they     come with fewer side effects and perhaps wider health benefits than antihypertensive drugs.      The aim of the study is to evidence the synergistic benefits of consuming plant (and     specifically olive) phenolics alongside achieving the recommended guidelines for physical     activity in individuals with elevated blood pressure.   "
65998|NCT02421822|"     The purpose of this study is to test the Fitwits office tool and games with 6-9 year old     children and their parents to: 1) assist parent-child dyad with correct BMI status     identification and understanding; 2) address nutrition, portion size, and activity cues; and,     3) track BMI trajectory over 12-month period.   "
65999|NCT02421809|"     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the     spectrum of gluten-related disorders. No data are available on the prevalence of oral lesions     in NCWS. Our study aims to evaluate the prevalence of oral lesions in NCWS patients and     search for correlations with other clinical characteristics. This prospective observation     study will include 90 NCWS patients with irritable bowel syndrome (IBS)- like symptoms, 90     IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the     Gastroenterology Units of the University of Palermo. Elimination diet and double-blind     placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent     oral examination to assess the presence or not of oral soft and hard tissue lesions     potentially associated to NCWS and CD.   "
66000|NCT02421796|"     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the     spectrum of gluten-related disorders. No data are available on the prevalence of low bone     mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of malnutrition in NCWS     patients and search for correlations with other clinical characteristics. This prospective     observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like     symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine     and at the Gastroenterology Units of the University of Palermo. Elimination diet and     double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All     subjects underwent nutritional parameters measurement, duodenal histology, Human Leucocyte     Antigen (HLA) DQ typing and body mass index (BMI) evaluation.   "
66001|NCT02421783|"     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the     spectrum of gluten-related disorders. No data are available on the prevalence of low bone     mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS     patients and search for correlations with other clinical characteristics.      This prospective observation study will include 90 NCWS patients with irritable bowel     syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at     the Internal Medicine and at the Gastroenterology Units of the University of Palermo.     Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS     diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA),     duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation     and assessment for daily calcium intake.   "
66002|NCT02421770|"     Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease characterized by     outbreaks or flares. It affects 0.2-1.9% of the population. Although the etiology is unknown,     the pathogenesis of OLP is known to involve an immune disorder, with epithelial damage caused     by cytotoxic CD8 + lymphocytes. Clinically, the disease is characterized by different types     of lesions - papular, reticular and in the form of plaques - that can alternate with erosive     and/or ulcerative areas. A variety of treatments have been proposed for OLP: topical or     systemic corticosteroids, cyclosporine, retinoids, azathioprine, tacrolimus, pimecrolimus,     photochemotherapy and surgery. Patients with symptomatic OLP often require intensive therapy     to reduce the signs and symptoms. The disease can produce considerable morbidity and alter     patient quality of life, particularly in the presence of ulcerative lesions.      There is no fully resolutive and effective treatment - the management strategy focusing on     the use of drugs that counter tissue inflammation and the underlying immunological     mechanisms. The main inconvenience of these treatments is represented by the side effects     they usually produce.   "
66004|NCT02421744|"     Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training     followed by a structured 3 months home exercise program would have higher benefits compared     to a delayed-treatment group as control in people with multiple sclerosis and mild to     moderate gait impairment.      Our secondary hypothesis is that there could be retention of clinical gains in subjects that     underwent TOCT plus structured 3 months home exercise program.   "
66005|NCT02421731|"     Gait disabilities affect personal activities and quality of life of progressive multiple     sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of     walking movements and imitation of a nearly normal gait pattern during treadmill training at     a higher speed has been developed and recently introduced in clinical settings. However,     until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group     of stroke, spinal cord injury and MS subjects.      In addition, the training-induced neural and biological changes potentially related to the     mechanisms of recovery remain undefined.      The primary aims of this study are:      to test the feasibility of RAGT in a group of progressive severely disabled MS patients and     to test the hypothesis that this intensive intervention could have higher benefit, compared     with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot     Walk (T25FW)      The secondary aims of this study are:      to determine whether fatigue, Quality of life, balance and locomotor function are improved by     RAGT; to determine whether gait training influences markers of plasticity including clinical     and circulating biomarkers to search for a possible correlation between clinical outcomes and     clinical and circulating biomarkers   "
66006|NCT02421718|"     Motive:      In order to improve the treatment technique, a comprehensive follow-up program is needed to     obtain all relevant patient, treatment and toxicity data from lung cancer patients.      Goal:      To set-up and maintain a database containing treatment results in terms of tumor control,     side effects, complications and patient-reported quality of life.      A standard database of patients receiving photon treatment will be created. These data are     then linked to dose-volume data of radiotherapy, with the aim to build prediction models for     both tumor control and toxicity after radio (chemo) therapy that can later be used for     selecting patients for proton treatment.   "
66007|NCT02421705|"     Aim:      More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European     research project.   "
66019|NCT02421549|"     A retrospective, multi-center, proof-of-concept study to evaluate the use of remote     monitoring in rural emergency departments to decrease time to treatment decision for     pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The     purpose of the study is to determine if utilization of remote monitoring technology in a     rural emergency department may improve patient care.      Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in     the remote monitoring group comprised of patients with SJM devices compatible with the     unpaired transmitter and 100 patients will be in the usual medical care group comprised of     patients with SJM devices that are not compatible with the unpaired transmitter or that have     a competitor's device.   "
66020|NCT02421536|"     This research is being done to evaluate whether or not a customized version of the VibrentTM     (formerly FitNinjaTM) mobile app is a feasible way to help people manage and control the pain     from radiation sores (also referred to as mucositis) when treating head and neck cancers     with radiation. The mobile app will be designed to help people better understand the pain     from the radiation sores and how to better use their medications especially when they are     away from the hospital.   "
66176|NCT02419508|"     The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering     effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a PGA in     patients with open-angle glaucoma or ocular hypertension.   "
66008|NCT02421692|"     Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility     (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize     rehabilitation potential for return to prior level of function and reduce the risk of adverse     events in older adults. However despite a substantial increase in spending on SNF services     and minimal change in complexity of the caseload, 68% of patients are below their     pre-hospitalization level of function at discharge, 25% return to the community, and 18% are     hospitalized. This may be partially explained by current SNF approaches to patient care which     foster inactivity and participation in low intensity rehabilitation interventions     (preliminary data). Both inactivity and low-intensity interventions may perpetuate further     functional decline or impede maximal recovery. The serious implication of risk with     functional decline is exemplified by studies which have shown declines in physical function     can increase the risk of being re-hospitalized six-fold and may infer other long term effects     such as increased risk for mortality, morbidity, and institutionalization. Muscle weakness,     reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed to this     acute decline in function. However current rehabilitation strategies in SNFs do not promote     adequate dose and mode of interventions to induce beneficial systemic adaptations, perhaps     due to the lack of evidence on effective rehabilitation protocols for this medically-complex     population. Therefore, the investigators have designed an rehabilitation program, which     uniquely integrates principles of physiologic tissue overload with strengthening and     functional interventions for greater gains in physical function. Data will be collected on     the first cohort of patients who cycle through a SNF during Stage 1, in which usual care     occurs (5 months). Then, staff training on progressive rehabilitation interventions will     occur over 2 months. Finally, data will be collected on a second cohort of patients who cycle     through a SNF during Stage 2, in which progressive rehabilitation is implemented by SNF staff     (5 months). Given the high turnover of patients in SNFs (average length of stay ~21 days), 2     different cohorts of patients will be studied and the analysis will consist of independent     2-sample t-tests. During Stage 1 and 2, measures of physical function will be assessed on all     eligible patients at admission and discharge from SNF. Therapists will be assessed on     adherence to the protocol through documentation audits and use of on-site observational     checklist. Acceptability of the intervention by the patients will be assessed by a patient     satisfaction survey. Any adverse events will be obtained from the medical record and     documented. The discharge location of all patients will be documented.   "
66009|NCT02421679|"     This is a 12-week, multicenter, open-label extension study to evaluate the safety and     efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD     or related condition. Patients recruited into this trial are those who have successfully     completed the double-blind study, TNX-CY-P201 (AtEase Study). Patients will not be made aware     of the therapy they received during the double-blind study.   "
66010|NCT02421666|"     Asian Americans have the highest rates of chronic hepatitis B virus (HBV) infection (CHB) in     the United States.Those with CHB often report that they feel well even though they are at     high risk for complications. Because of the high incidence and prevalence of CHB, patients at     high risk need to be tested every 6 to 12 months for early signs of liver problems.This study     will answer critical questions for Asian Americans with CHB about improving timely testing.     Using a randomization process, 500 of these patients will receive either the Patient     Navigator plus Mobile Phone Text Messaging Intervention (PNMI) or standard care. At patients'     entry into the study, 6 months, and 12 months, information will be collected.Patient     navigators representing Asian cultures will receive a thorough HBV training. PNMI patients     will receive three patient navigator led education sessions and text messages over mobile     phone. Patients, patient advocates, physicians, and researchers of Center for Asian Health     (CAH) will be active study partners.      Patient Outcomes: The investigators expect to find better health outcomes and lower HBV     health gaps, as measured by the number of patients:        1. getting doctor-recommended tests at 6 and 12 months;        2. getting doctor-recommended HBV care;        3. improved HBV knowledge, a better quality of life, social support, and coping skills; and        4. having fewer barriers and less anxiety.   "
66011|NCT02421653|"     In this study, two intervention strategies to address iodine deficiency and prevent iodine     deficiency disorders in breast-fed weaning infants will be evaluated in a mild to moderate     iodine-deficient population in Zamboanga del Norte, Philippines, Southeast Asia.   "
66012|NCT02421640|"     This is a Phase II trial to study the effectiveness and security of cisplatin concurrent     chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only with IMRT in     treating patients with locoregionally advanced high risk nasopharyngeal carcinoma.   "
66013|NCT02421627|"     To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel     syndrome and evaluation by Magnetic Resonance Imaging (MRI).   "
66100|NCT02420496|"     To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution     and other markers of parenteral nutrition-associated liver disease.   "
66014|NCT02421614|"     This study aimed to investigate the effect of enteral feeding's macronutrient composition on     inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients     with acute respiratory failure. In this double-blind randomized control trial, 42 patients of     both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding,     will be randomly assigned to three groups of 14 each. First Intervention group; high-protein     low-carbohydrate diet with high olive oil, the second intervention group; high-protein     low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula.     Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6     (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ     failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.   "
66015|NCT02421601|"     The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in     patients with lumbar disc herniation.   "
66016|NCT02421588|"     Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the     activity and safety of PM01183 versus PLD or topotecan as control arm in patients with     platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the     experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).   "
66017|NCT02421575|"     This phase 0 trial studies hydroxychloroquine in blocking autophagy in patients with prostate     cancer who are undergoing surgery or active surveillance. Autophagy is a process in which     cells break down some parts of themselves to stay alive during times of stress, such as     starvation. This may allow cancer cells to survive damage from chemotherapy.     Hydroxychloroquine may block this process from happening.   "
66018|NCT02421562|"     Demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia     techniques, and this new tool will translate into a reduction of procedural distress and pain     in their patients, thereby opening the way to larger clinical trials in various pediatric     settings.   "
66036|NCT02421328|"     This is a prospective, randomized crossover study to recognize the effects of nasal     continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula     (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm     infants.   "
66021|NCT02421523|"     Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle     breakdown, weakness, and eventual death. Over the last 40 years parents have received little     guidance on the potential of exercise as a therapeutic strategy to maintain muscle function.     It is well known that high intensity exercise and eccentric contractions can result in muscle     damage in dystrophic muscle, yet the absence of muscle loading will conversely result in     muscle wasting. Recent research in rodent models and milder forms of muscular dystrophy     supports earlier studies that resistance exercise may have beneficial effects for maintenance     of muscle mass in dystrophic muscle. However, careful and systematic investigation into the     safety and feasibility of resistance exercise is needed to consider its implementation in     boys with DMD.      The goal of this project is to assess the safety and feasibility of a home based mild to     moderate-intensity strengthening exercise program in boys with Duchenne muscular dystrophy     (DMD). Evidence from milder forms of muscular dystrophy and mouse models of DMD suggests that     strengthening exercise may be beneficial for these children, but this area has not been     adequately explored using human subjects. The results of this study should provide     information to assist in the development of scientifically based recommendations concerning     optimal exercise parameters for patients with DMD.   "
66022|NCT02421510|"     This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin high dose     or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when     used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate     glycemic control with insulin therapy.   "
66023|NCT02421497|"     Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has     the potential to improve patient health care and management. The overall objective of     proposed project is to:        1. develop, customize, and optimize anatomic and functional MRI methods,        2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and        3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the          progression of renal dysfunction.      In addition to direct studies of the kidney, brain MRI studies will also be performed to     identify the cerebrovascular and cognitive effects of chronic renal function deficiency and     medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have     similar vascular bed, and both are susceptible to vascular injury, which provides the     pathological basis for the widely recognized association of reduced renal function with     prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in     the brain will be applied to explore the origins for widely observed CVDs and prevalent     cognitive impairment (CI) in kidney disease patients.   "
66024|NCT02421484|"     This is a Phase I open label dose escalation trial of human allogeneic bone marrow derived     mesenchymal stromal cells (MSCs) for the treatment of septic shock. The main purpose of the     study is to assess the safety of MSCs in patients with septic shock.   "
66025|NCT02421471|"     This study is a mandatory post launch observational study in South Korea of 3.000 patients     receiving treatment for the first time with a new medicinal product, ingenol mebutate gel     (Picato®), approved for topical treatment of actinic keratosis.      Each patient is observed for 8 weeks after treatment completion.   "
66026|NCT02421458|"     RCT to compare two radiation schemes for palliative HeadNeck cancer   "
66027|NCT02421445|"     This is an observational study to characterize human milk of mothers delivering term SGA and     term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months     postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be     randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment     period for the study in India is for 6 months.   "
66028|NCT02421432|"     The purpose of this study is evaluation of the safety and the efficacy of transanal total     mesorectal excision in difficult case.      Difficult case is defined as below;      - If any one of the following (1 or 2 or 3)        1. BMI: 30 or more        2. Tumor size: more than 7cm in long diameter        3. CRM: mesorectal fascia involvement or less than 1 mm on MRI   "
66029|NCT02421419|"     This research is being done to compare pain relief and efficacy of trigger finger injection     using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus     corticosteroid/saline combination.   "
66030|NCT02421406|"     The goal of this project is to determine whether an Internet-based weight loss program will     lead to weight loss and improvements in cardiovascular disease risk factors in people living     with HIV.   "
66031|NCT02421393|"     Type 2 diabetes mellitus (T2DM) is associated with increased fracture risk despite normal to     increased bone mass, thus suggesting poor bone quality. This study is aimed at weighing the     effect of an exercise intervention program on parameters of bone quality in patients with     type 2 diabetes mellitus. Two hundred patients with T2DM will be randomized to supervised     exercise training on top of standard care (exercise, EXE, group; n=100) versus standard care     (control, CON, group; n=100) for 24 months.   "
66032|NCT02421380|"     The purpose of the study is to test a new approach to see if the test results can be     reproduced each time the Magnetic resonance imaging (MRI) is done for an individual patient.     The study will explore the use of an imaging agent called hyperpolarized [1-13C] pyruvate     (HP) with MRI scans. (MRI) is a technique that takes pictures of the body's organs using a     magnetic field and radiofrequency waves that cannot be felt. In order to accomplish the goal     of the study the patient will have two hyperpolarized MRI scans to assess if scans can be     reproduced. The hyperpolarized MRI scans will be compared with the pathological results of     the surgery to see if the hyperpolarized MRI provides additional information regarding     disease metabolism.   "
66033|NCT02421367|"     This study is being conducted to evaluate the safety and immunogenicity and antibody     persistence of the candidate dengue vaccine.   "
66034|NCT02421354|"     The goal of this clinical research study is to learn if nivolumab can help to control MF. The     safety of this drug will also be studied.   "
66035|NCT02421341|"     This study is being done because the investigators are trying to understand how feedback from     the muscles can influence your blood pressure and breathing during exercise, and if the     investigators can reduce this response in heart failure patients. The investigators are also     trying to determine ways to improve tolerance to exercise in heart failure patients.   "
66038|NCT02421302|"     This will be cohort study design with both qualitative and quantitative methods of data     collection. The investigators are aiming to study 64 HIV positive children as healthy     controls either initiating ART or already on ART and 86 malnourished HIV infected children on     ART or naïve initiating ART and RUTF aged between 6 months to 12 years. Primary carers will     be asked to provide informed consent whereby the children and primary carers will be enrolled     into the study and followed up for 12 weeks.   "
66039|NCT02421289|"     Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV     metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse     event especially homozygous variant CYP2B6 *6/*6. This trial was designed to compare the     proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between     patient who did CYP 2B6 guided EFV dose and who did not.   "
66040|NCT02421276|"     This study plans to learn more about Down syndrome. The investigators think there is a     different level of the AIRE gene in individuals with Down syndrome. The investigators think     that the AIRE gene level can provide more insight about depressed immune cell function in     individuals with Down syndrome. Patients are being asked to be in this research study because     the investigators want to see if their blood contains more of less of the AIRE gene.   "
66041|NCT02421263|"     The current protocol is a pilot study of the effects and possible utility of     psilocybin-facilitated experiences for professional religious leaders. We hypothesize that     religious professionals, given their interests, training, and life experience, will be able     to make nuanced discriminations of their psilocybin experiences, thus contributing to the     scientific understanding of mystical-type experience. As we better characterize the     phenomenology of psilocybin-induced mystical experiences, we may apply this knowledge to     improve potential treatment studies in the future. A primary objective is to investigate     changes in psychological functioning, spirituality, health, well-being, prosocial attitudes     and behavior in professional religious leaders that may occur after receiving psilocybin     under supportive conditions. A secondary objective is to determine whether participants who     report having had the strongest mystical-type effects during psilocybin sessions will show     the largest positive changes in the Interim Questionnaire.   "
66042|NCT02421250|"     The study is a clinical trial to determine whether more efficient medical and operational     outcomes can be achieved with using the new SpHb monitoring during triage in the emergency     room setting. The investigators also evaluate the accuracy of the measurements of the SpHb     device by Maximo versus the gold standard of central hospital laboratory value. In addition,     the investigators will assess patient satisfaction with the tool.   "
66043|NCT02421237|"     The purpose of the present study is to build upon the investigators' previous exploratory     intervention development study by conducting an adequately-powered, randomized controlled     trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with     schizophrenia-spectrum disorders.   "
66044|NCT02421224|"     The investigators will conduct a cluster randomized controlled trial of several behavioral     interventions for smoking cessation among a sample of employees at large workplaces in the     Bangkok metropolitan area. The study aims to test the impacts of different incentive     structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. The     interventions are designed to elucidate certain principles from the field of behavioral     economics.   "
66045|NCT02421211|"     The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir     and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and     ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV)     genotype 1 infection.   "
66046|NCT02421198|"     Over one-third of children and adolescents are overweight and nearly 1 in 5 of them are     obese. Metabolic syndrome, a strong predictor of Type 2 diabetes (T2D) and cardiovascular     disease (CVD), occurs in up to 44% of obese youth, foreshadowing greater prevalence and     earlier onset of T2D. Without effective interventions, diabesity will worsen, T2D     prevalence will increase, and adults will face its consequences at younger ages. Given the     strong association between obesity and chronic disease risk factors in youth, the     investigators contend T2D prevention (and CVD prevention) is akin to weight control and     obesity prevention. The objective of the proposed project is to develop a family-centered,     community-based program for T2D prevention in peripubertal (9- to 12-year-old) youth. Using     participatory methods, the investigators intend to adapt the successful adult-focused YMCA     Diabetes Prevention Program (YDPP) for youth and families and assess the feasibility,     participant acceptance of and adherence to the YFDPP using two delivery formats: a 12-week     YMCA-based face-to-face program and a 12-week combined face-to-face plus mobile device-based     program. The proposed study will test the investigators premise that delivery with technology     can reduce participant perceived burden, improve adherence, and lead to improved     anthropometric (height, weight and BMI and waist circumference), behavioral (diet and     physical activity) and physiological outcomes (fasting insulin, glucose, lipid, blood     pressure). The investigators will use the resulting data to design an appropriately powered     full-scale trial. The importance of the proposed study is underscored both by the statistics     cited above and the recent call for proposals to translate efficacious clinical interventions     into effective community programs for youth. The potential impact of the proposed     intervention is great in that the program will be delivered by paraprofessionals from the     community without university researchers; significant in that it targets a major public     health challenge in children and includes assessment of objective behavioral and clinical     data; and innovative in that it focuses on an at-risk population, takes place at a popular,     accessible community venue, and uses mobile technologies to extend reach and increase     engagement of youth and families with intervention content. The long-term goal is to create a     scalable, replicable, and sustainable program that overcomes existing barriers to     implementation and dissemination of evidence-based, research-proven diabetes prevention     programs to youth and families, thereby improving population health.   "
66047|NCT02421185|"     The purpose of this study is to determine recommended Phase 2 dose [RP2D]) and the objective     response rate of JNJ-42756493 (erdafitinib) in advanced hepatocellular carcinoma (HCC)     participants with fibroblast growth factor (FGF) 19 amplification.   "
66048|NCT02421172|"     This is a randomized, double blind, multicenter study in patients with moderate to severe     chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of     multiple doses of CJM112 in comparison to placebo. The study has two periods to explore     preliminary dose effects.   "
66080|NCT02420756|"     The Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study will establish an     open-label, longitudinal cohort study to assess the impact of amyloid PET on patient     outcomes. The study will be performed in accordance with the Center for Medicare & Medicaid     Services (CMS) policy of Coverage with Evidence Development (CED) in Medicare beneficiaries     who meet the Appropriate Use Criteria (AUC) for amyloid PET (Johnson et al. 2013). Our     hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the     underlying cause of cognitive impairment, that this will translate into earlier counseling     and interventions in these domains, and that these interventions will lead to improved     outcomes.   "
66049|NCT02421159|"     The Brooklyn Community United (BCU) study is a supplement to the main research study titled     Peer Driven Intervention to Seek, Test, & Treat Heterosexuals at High Risk for HIV. The     main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#:     11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection     (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)).      HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in     HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14%     of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in     the VBS sample.      The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with     undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central     Brooklyn.      The supplement study hypotheses are:      (H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key     socio-demographic characteristics across the samples, RDS-ASTN participants will have less     HIV testing experience.      (H2) Controlling for potential differences on key socio-demographic characteristics across     the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS     and RDS-CTTN.      (H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will     engage in the Treat and Retain intervention phase.      (H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%),     all of whom will be HIV infected, will be linked to care within 3 months.   "
66050|NCT02421146|"     The purpose of this project is to examine brain function before, during, and after the     administration of tDCS (Transcranial Direct Current Stimulation). The brain can perform its     job well or poorly depending on many things. The investigators will be using computer tasks     and paper and pencil questionnaires to measure the relationship between brain performance and     the administration of tDCS. In addition, the study team will be using functional magnetic     resonance imaging (fMRI) and related imaging techniques to see how your brain works and     compare it with the results we collected from the paper and pencil questionnaires. This study     will enroll both schizophrenia patients as well as healthy volunteers without any major     psychiatric disorder or physical illness.   "
66051|NCT02421133|"     In France, it has be estimated that the hospital readmission rate within 30 days of patients     aged 75 or older is 14% (IC95% [12.0-16.7]), nearly a quarter being avoidable. There is     evidence that interventions bridging the transition from hospital to home involving a     dedicated professional (usually nurses) would be most effective in reducing the risk of     readmission, but the level of evidence of current studies is low. Our study aims to assess     the impact of a program of transitional care from hospital to home for people of 75 years old     or more admitted to acute care.   "
66052|NCT02421120|"     There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered     antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly     approved broad spectrum intravenous antibiotic, which has potent in vitro activity against     multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF     pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of     ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one     of 4 participating hospitals in the US. Patients will remain on standard of care IV     antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood will     be sampled after the final dose to determine concentrations and pharmacokinetics of     ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day     study.   "
66053|NCT02421107|"     The company who have developed the GlySure product have previously carried out a study to be     able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels.     This was done with patients in the intensive care unit (ICU) after heart surgery.      The company now want to confirm that the GlySure product is accurate at measuring blood     glucose levels on all patients who stay in the ICU.      This clinical study requires 40 patients and is to check the safety of a continuous Glucose     Monitoring System (GlySure) and it's performance in comparison to separate individual blood     glucose testing using a hand held blood tester called i-STAT. Each patient must be in the     study for at least 36 hours.      The main benefit of continuous blood glucose monitoring is that it gives a true picture of     the glucose status of a patient and this can potentially help avoid the glucose level     dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can     intervene based on `real-time` data on the glucose levels.      In this study patient treatment is not dictated by the data measured during the study.     Clinicians are blind to the results on the GlySure monitor.   "
66054|NCT02421094|"     A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial     to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the     Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced     Fibrosis   "
66055|NCT02421081|"     The radial and ulnar artery injuries related with the wrist cut are frequently encountered.     There are many factors which are effective on the improvement of these arterial structures     was repaired with microsurgical techniques. Recently has begun to focus on neointimal     thickening and endothelialization of the role in vascular healing and maturation made on     histopathological study. In this study, the radial and ulnar artery laceration repair healing     with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of the     effect of the distribution of lymphoid cells has been investigated. The investigators think     that; thus by demonstrating the positive impact that may arise; autologous endothelial     progenitor cells which are obtained in patients; continuation of anastomotic patency     undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also     ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The     investigators believe could be used for the reimplanted tissue in the limb breakage ensuring     that survive.   "
66081|NCT02420743|"     Pregnant women with iron deficiency anemia during third trimester will be assessed for serum     ferritin and peak systolic value for fetal middle cerebral artery to find out their     correlation with preterm delivery.   "
66082|NCT02420730|"     This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3     different concentrations of AGN-232411 topical ophthalmic solution in healthy participants     and participants with dry eye.   "
66056|NCT02421068|"     This study will provide information on the pharmacokinetics, safety and effectiveness of     off--label drugs used in critically ill premature infants: doxapram, fentanyl, midazolam,     paracetamol, phenobarbital, sildenafil, levetiracetam, ibuprofen and fluconazole. PK/PD     analysis with NONMEM (non-linear mixed effects modelling) will result in (adapted) dosage     guidelines, thus contributing towards an improvement in the quality of care and cost     efficiency. Furthermore the development of Dried Blood Spot (DBS) analysis is investigated     for these drugs as a minimally invasive method for conventional patient care and to perform     pharmacological studies in children. The adapted dosage guidelines will be implemented     directly into clinical practice in collaboration with the NKFK. Therefore the study is     designed as an observational multicenter study to be able to collect sufficient data for the     drugs of interest.   "
66057|NCT02421055|"     Recent studies have shown that bacteria within the gut play an important role in diabetes     improvement after bariatric (weight-loss) surgery. Bariatric surgery fundamentally changes     the environment within the gut, which results in changes to the makeup of the trillions of     bacteria living within it. These changes in the gut bacteria can affect the body in a number     of complex ways, which we are only just beginning to understand. For example, gut bacteria     breakdown food we are unable to absorb ourselves, leading to altered sugar levels and can     release molecules that act to reduce appetite.      In this study we aim to find out how bariatric surgery changes the gut bacteria and how this     leads to weight loss and improvement of diabetes. With this understanding we hope to discover     potential targets for future treatments, such as identifying beneficial bacteria that could     be supplemented with probiotics in patients.      Additionally, although highly successful, up to 30% of obese patients do not undergo     improvement of their diabetes after bariatric surgery. We aim to identify molecules within     the patient's blood or urine that are able to predict the likely chance a patient will     undergo improvement in their diabetes after bariatric surgery to help clinicians select     patients most likely to benefit.   "
66058|NCT02421042|"     This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in     subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh     system, who will be matched with normal healthy subjects as controls.   "
66059|NCT02421029|"     The researchers propose to investigate the prevalence of gadolinium in the urine of patients     with a prior gadolinium-enhanced MRI before and after a edetate calcium disodium challenge.     Moreover, will investigate if there is any correlation of gadolinium urine levels with levels     of endogenous (e.g zinc) and xenobiotic metals.   "
66060|NCT02421016|"     The bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in     patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES     is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic efficacy     as assessed by angiography at 6-8 months.   "
66061|NCT02421003|"     The recovered blood into the surgical site at the border of the fields, is very rich in red     blood cells, due to the adjacency of the bone marrow and the sternum.      The blood recovered from the surgical site at the border of the fields, is richer in red     blood cells than the bloodstream of the patient.      The recovered blood into the surgical site at the border of the fields, is not contaminated     and bacteriological cultures are negative.      Consequences: The recovered blood in the surgical site at the edge of fields, can be     recovered in the Saver® Cell for reprocessing and re-injected into the patient.      There isn't in our knowledge of published clinical data on the volume and composition of the     recovered blood in the surgical site after cardiac surgery.      The analysis of the available literature does not allow to estimate the expected outcomes us.     Therefore, this study will be exploratory in nature and will aim to estimate the volume and     the content of red blood cells from blood recovered, and generate clinical data to be used in     subsequent confirmatory tests.   "
66062|NCT02420990|"     Attention-Deficit/Hyperactivity Disorder (ADHD) exists in 20-50% of the 3 million adolescents     annually enrolled in outpatient mental health and substance use treatment. Adolescents with     ADHD present deficits in attention, self-regulation, and social competence that significantly     impede achievement of developmental and educational milestones. Currently there are only two     evidence-based treatment options for this age group: academic training and stimulant     medications. Both options remain vastly underutilized. Academic training is not available in     most school settings and rarely implemented in clinical care. Similarly, ADHD medications are     rarely utilized with adolescents in primary or specialty care for a host of reasons related     to stigma, misinformation about effects and side effects, and adolescent autonomy issues.     Moreover, the widespread fragmentation of pharmacological versus behavioral services prevents     families from making informed treatment selections.      The primary objective of this randomized parametric trial is to compare the effectiveness of     behavioral only versus integrated (behavioral plus medication decision-making) interventions     for adolescents with ADHD in outpatient behavioral services. The behavioral intervention,     Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA), contains three     components: ADHD psychoeducation, family-based motivational interventions, and academic     training. The medication decision-making intervention, Medication Integration Protocol (MIP),     contain three components: psychoeducation about ADHD medication, family decision-making, and     medication management. The study will compare the effects of two legitimate treatment options     for adolescents with ADHD on service utilization, behavioral symptoms, and quality of life.     It will generate new evidence on patient-centered treatment selection that aligns with     family-specific principles and treatment goals.      This parametric comparative trial will randomly assign 140 inner-city adolescents with ADHD     to (1) CASH-AA Only or (2) CASH-AA + MIP. Treatment will occur in community behavioral health     clinics. All participants will receive behavioral interventions (CASH-AA): family     psychoeducation in ADHD symptoms, executive functioning, and developmental impacts;     family-based motivation and ADHD accommodation interventions; and academic training focused     on home environment support and organizational skills. Half of the participants will also     receive medication decision-making interventions (MIP): ADHD medication psychoeducation,     family decision-making interventions, and (for those who elect to start medication)     coordinated medication management. Half of the sample will have comorbid substance use     problems. Treatment will occur in three community clinics; therapists will be randomly     assigned to study condition. Caregivers and adolescents will complete assessments at     baseline, 3, 6, and 12-month follow-up. Multilevel modeling will compare the effectiveness of     each condition on key patient and service use outcomes. Patient-centered analyses will     explore differential treatment effects based on (a) Medication decision (yes/no); (b)     Substance use comorbidity (yes/no); (c) Race/Ethnicity (Hispanic, African American).      Quantitative outcome analyses will test for service use effects, symptom reduction, and     quality of life improvements that are primary reasons for seeking clinical services.     Qualitative interviews will document family-specific rationale for decisions about     medication, compliance with behavioral and medication interventions, and suggestions for     improving services and service integration. Note that families assigned to CASH-AA Only will     retain the option of pursuing ADHD medication through treatment-as-usual procedures at their     respective clinic. Similarly, families assigned to CASH-AA + MIP will not be required to     start ADHD medication. Instead, they will receive informed-choice interventions and can     choose when and if to start medication; the study will assess the impact of these decisions     on clinical outcomes.      If proven efficacious, the CASH-AA and MIP protocols could be rapidly disseminated     individually or as an integrated protocol into routine behavioral healthcare settings. The     protocols can also be readily combined with other behavioral treatments to form a     multicomponent treatment package for adolescents with co-occurring behavior problems. In     addition, the family-based, patient-centered CASH-AA and MIP protocols could be delivered in     conjunction with other family-based treatments or with individual approaches that flexibly     include caregivers in multiple treatment sessions. This makes CASH-AA and MIP highly     efficient clinical resources for addressing ADHD-related problems in any outpatient setting     that serves adolescents and their families.   "
66905|NCT02410005|"     This study is a single center open-label randomized controlled trial designed to evaluate the     efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and     macroalbuminuria.   "
66064|NCT02420964|"     The study will be a prospective randomized trial involving human subjects. The study     population will consist of all infertility patients presenting to the Carolinas Medical     Center Women's Institute who will require injectable use.      Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded     from the study.      Independent Variables: The independent variable is the random assignment of each participant     to receive either web-based or one on one teaching.      Outcome Variables: The primary outcome variable is the level of knowledge after the     intervention. Secondary outcome variables include level of satisfaction with education,     preference of educational method, and time required to teach.      Confounding Variables: Potentially confounding variables include age, race, and prior     experience with web-based teaching.   "
66065|NCT02420951|"     The purpose of this study is to determine if an additional injection of local anesthetic     immediately prior to removal of the local anesthetic infiltration catheter on postoperative     day one is effective in increasing pain reduction, patient satisfaction or outcome measures     following total knee replacement (TKR). It is hypothesized that an additional injection of     30ml of .5% bupivacaine solution immediately before infiltration catheter removal will     provide pain reduction, patient satisfaction and outcome measures equal or superior to     catheter removal with no additional injection.      Patients who are undergoing unilateral total knee replacement (TKR) and choose to participate     will be randomly assigned to a treatment group.Patients in group one (treatment group) will     receive a 30ml dose of .5% bupivacaine solution injected into the local anesthetic     infiltration catheter immediately prior to its removal on postoperative day one. Patients in     group two (control group) will receive no additional medication during local anesthetic     infiltration catheter removal.   "
66066|NCT02420938|"     The goal of this clinical research study is to learn if urelumab given in combination with     rituximab can help to control CLL or SLL. The safety of the drug combination will also be     studied.   "
66083|NCT02420717|"     The goal of this clinical research study is to learn if ruxolitinib or dasatinib in     combination with chemotherapy can help to control Philadelphia Chromosome (Ph)-like acute     lymphoblastic leukemia (ALL). The safety of these drug combinations will also be studied.   "
66067|NCT02420925|"     The investigators hypothesize that in patients with gastroparesis, gastric emptying will     improve with celiac plexus block. By improving gastric emptying, symptoms related to     gastroparesis including nausea, vomiting, bloating, abdominal pain, and weight loss, will     also improve.      In order to study this hypothesis, the investigators will enroll patients with gastroparesis     who are non-responsive to the current treatments available. Patients will fill out a     questionnaire to assess the severity of their symptoms then undergo Ansar testing (a     non-invasive test) to measure their autonomic function respectively. Then, patients will     undergo a celiac plexus block which is performed via an upper endoscopy. One week after the     procedure, patients will be asked to undergo a gastric emptying study as well as repeat the     Ansar testing to evaluate for any improvement in the gastric emptying and autonomic function     respectively. Patient will be asked to repeat the questionnaire, one, two, three, and eight     weeks after their procedure.   "
66068|NCT02420912|"     The goal of this clinical research study is to learn if nivolumab in combination with     ibrutinib can help control CLL, NHL, or SLL. The safety of this drug combination will also be     studied.   "
66069|NCT02420899|"     The purpose of this study is to determine whether Rosuvastatin 10mg/d or 20mg/d for 36 weeks     can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute     Coronary Syndrome (ACS) patients.   "
66070|NCT02420886|"     Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF     5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis     and implantation outcomes.   "
66071|NCT02420873|"     The goal of this clinical research study is to learn if lorvotuzumab mertansine can help to     control blood cancers that have the CD56 tumor marker. The safety of this drug will also be     studied.   "
66072|NCT02420860|"     The goal of this clinical research study is to learn if the combination of elotuzumab and     revlimid (also called lenalidomide) can help to prevent MM from coming back after patients     have had an autologous stem cell transplant. The safety of this drug combination will also be     studied.   "
66073|NCT02420847|"     This clinical research study is made up of 2 phases.      The goal of Phase 1 of this study is to learn the highest tolerated dose of the combination     of ixazomib, gemcitabine, and doxorubicin that can be given to patients with urothelial     cancer.      The goal of Phase 2 of this study is to learn if the combination of ixazomib, gemcitabine,     and doxorubicin can help to control urothelial cancer.      The safety of the drug combinations will be studied in both phases.   "
66074|NCT02420834|"     Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear     quality and insufficient quantity. Treatments are traditionally in the form of artificial     tears applied to the ocular surface. However, there is little evidence in the scientific     literature that demonstrates their efficacy relative compared to each other, nor how to     decide which one might be most effective for an individual patient. Therefore the     investigators aim to examine the efficacy of different classes of artificial tears (those     designed to increase viscosity, reduce evaporation or to mimic the component balance of the     natural tears). In addition, the investigators also aim to determine how the treatment     preferred by an individual could potentially have been predicted from their baseline     condition.   "
66075|NCT02420821|"     This multi-center, randomized, open-label study will evaluate the efficacy and safety of     atezolizumab (MPDL3280A) plus bevacizumab versus sunitinib in participants with inoperable,     locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior     systemic active or experimental therapy, either in the adjuvant or metastatic setting.   "
66076|NCT02420808|"     A nationwide registry of patients with acute coronary disease to evaluate epidemiological     patient characteristics, medical management, implementation of invasive strategy, patient     outcome and impact on quality of life in Greece.   "
66112|NCT02420340|"     This pilot study will collect information about the the potential to use an evidence-based     skills training program designed for older people with serious mental illness (SMI), the     Helping Older People Experience Success (HOPES) program, to help nursing home residents with     SMI gain the skills needed to successfully live in the community.   "
66185|NCT02419391|"     A total of 63 subjects will be recruited into three groups (18 subjects per group will     receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen     suspension of MVA BN RSV.      Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per     0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.   "
66077|NCT02420795|"     This clinical research study will be done in two parts.      The goal of the first part is to find the highest tolerable dose of ONC201 that can be given     to patients with relapsed or refractory MCL, DLBCL, and TLCL. Groups of subjects will receive     increasing doses of ONC201 by mouth on day 1 of each 21 days cycle or on Day 1 of every week     until there are side effects that are not tolerated or a maximum of 625 mg has been found to     be tolerable.      As a result of new information, it has been decided that subjects in Arm A will continue     receiving their dosing every 3 weeks. All other subjects will be dosed weekly. The dose you     receive may be too low to have an effect or so high it causes bad side effects. In the second     part of this study the highest dose of NC201 will be given to learn if ONC201 can help to     control the disease. Please note that this is the first time ONC201 will be given to human     subjects.   "
66078|NCT02420782|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)     and pharmacodynamics (PD) of single and multiple ascending oral doses of ASP6282 in healthy     male and female subjects. 1 cohort (elderly) receives also a midazolam dosing.      This study will also explore the effect of itraconazole (another drug) on the PK of ASP6282,     as well as to evaluate the safety and tolerability of ASP6282 alone and in combination with     itraconazole in healthy male and female subjects.      Also, this study is to evaluate the PD and PK effects of single oral doses of ASP6282 on     pilocarpine-induced salivation and pupil diameter in healthy nonelderly male and female     subjects.   "
66079|NCT02420769|"     The purpose of this study is to determine whether assessing color doppler of corpus luteum     and uterine artery is useful in predicting patients who will complete pregnancy. The     investigators will add to this the usefulness of serum progesterone and CA125 in prediction.   "
66195|NCT02419261|"     Assessment of sensory and motor blockade of adductor canal blockade performed for anterior     cruciate ligament repair in comparison with femoral nerve blockade.   "
66084|NCT02420704|"     Although many studies have evaluated the relationship between endometrial thickness and IVF     outcome, the results are still controversial. We notice that, during our daily work, for     patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a     huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome seems     to have little association with endometrial thickness. Thus, the aim of this prospective     observational study is to explore the relationship between endometrial thickness and IVF     outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers,     respectively.   "
66085|NCT02420691|"     The goal of this clinical research study is to learn if LEE011 can help to control advanced     neuroendocrine tumors of the foregut. The safety of this drug will also be studied.   "
66086|NCT02420678|"     Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause     of cancer-related mortality worldwide. Despite the recent advances in the treatment of HCC,     the prognosis of HCC is still poor even after curative treatment.      Performance status has shown to be associated with long-term survival and prognosis in     patients with HCC, and it is one of the important factors in the Barcelona Clinic Liver     Cancer (BCLC) staging system. Recently, the researches on health-related quality of life     (HRQL) of cancer patients have been progressed. The most widely used surveys to assess HRQL     of cancer patients are Functional Assessment of Cancer Therapy-Generic (FACT-G) and European     Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire     (QLQ)-C30. Since those two are mainly about cancers in general, HCC specific surveys were     developed.      The FACT-Hep questionnaire has 45-items specifically focusing on patients with hepatobiliary     cancers. EORTC QLQ-hepatocellular carcinoma 18 (HCC 18) is an 18-item questionnaire designed     to be used along with the EORTC QLQ-C30 for patients with HCC. An 18-item National     Comprehensive Cancer Network (NCCN)-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) is     a specific questionnaire for advanced hepatobiliary and pancreatic cancers. However, there is     no consensus whether it would be appropriate to adopt HRQL as a prognostic variable in HCC     staging system. Moreover, there is limited information available about the impact of     patients' HRQL on long-term outcome in patients with HCC.      Thus, in this study, the researchers will investigate whether HRQL can be an important factor     in HCC staging system by testing the reliability and clinical validity of FACT-Hep, EORTC     QLQ-HCC18, and NFHSI-18. Second, the investigators will evaluate the relation of HRQL with     treatment efficacy, recurrence and survival outcome. Lastly, the investigators will suggest     the suitable questionnaire module for patients with HCC.   "
66087|NCT02420665|"     The goal of this clinical research study is to compare a type of imaging called     high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the     standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy     procedure. Researchers also want to learn if HRME images can show the difference between     cancerous tissue and normal cervical tissue.   "
66088|NCT02420652|"     This randomized phase II trial studies how well metformin hydrochloride and aspirin work in     treating patients with hormone-dependent prostate cancer that has progressed after surgery or     radiation therapy. Metformin hydrochloride and aspirin may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. It is not yet known whether giving     metformin hydrochloride and aspirin together can slow the growth of prostate cancer.   "
66113|NCT02420327|"     The aim of this study is to test whether the attention-enhancing effects of low-dose nicotine     can be enhanced by the drug galantamine, FDA-approved for the treatment of Alzheimer's     disease. This proof-of-principle study is performed in healthy non-smokers and involves two     single exposures to a nicotine patch (7 mg/24 hrs) and two single exposures to galantamine (4     mg). The dose of galantamine is substantially lower than the clinical dose range of 16-24     mg/day. The hypothesis is that performance-enhancing effects of nicotine are greater in the     presence of this low dose of galantamine.   "
66089|NCT02420639|"     The aim of this prospective, interventional study is to assess the feasibility and safety of     the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the     treating physician is treating with targeted temperature management. Comparison of outcomes     will be made to historical controls. The primary outcome is the feasibility of inducing,     maintaining, and rewarming patients from targeted temperature management using the Esophageal     Cooling Device (cooling rate, rewarming rate, and the percent of time within goal temperature     during the goal-temperature maintenance period). Evaluation of adverse events (including     cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia,     odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal injury, and     esophagitis) will be closely monitored during the whole period of targeted temperature     management (secondary endpoint).   "
66090|NCT02420626|"     The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano     Corporation, to evaluate the short and long term performance and clinical outcomes of the     Crux Vena Cava Filter System.   "
66091|NCT02420613|"     The goal of this clinical research study is to learn the highest tolerable dose of     temsirolimus that can be combined with a stable dose of vorinostat and/or radiation therapy     and given to patients with diffuse intrinsic pontine glioma (DIPG). The safety of this     treatment combination will also be studied.   "
66092|NCT02420600|"     Head and neck squamous cell carcinomas (HNSCCs) are mainly caused by tobacco, alcohol     consumption and betel nut chewing and the sixth most common cancer in the world. Despite     significant advances in the treatment modalities involving surgery, radiotherapy, and     concomitant chemoradiotherapy, the 5-year survival rate remained below 50% for the past 30     years.      The worse prognosis of these cancers must certainly be linked to the fact that HNSCCs     strongly influence the host immune system. During this process, mesenchymal tumor-like cells     are highly mobile and enter quickly adjacent structure (intravasation), from where they     travel through lymphatic and blood vessels as circulating tumor cells (CTC), which are single     cells with malignant potential detected in the peripheral bloodstream and essential for     establishing metastasis.      Programmed death 1 (PD-1) and its ligand (PD-L1) play pivotal roles in regulating host immune     responses. Substantial evidence has demonstrated that PD-L1 can deliver an inhibitory signal     to PD-1 expressing T cells, leading to suppression of the immune response by inducing     apoptosis, energy, unresponsiveness and functional exhaustion of T cells. However, the     inhibitory effects of this pathway on the function of cytotoxic T lymphocytes, the main     effector cells in HNSCC patients, are not well defined.      In this study aims to solve two main problems: one is to improve and try to optimize current     protocols of CTC isolations based on the investigator previous work, which is one of most     challenging problems in CTC field to date; the other is to understand the status of immune     system in HNSCC patients, especially focusing on PD-1-PD-L1 pathway and its expressions.     After series basic experiments of immune cell analysis and conditional adjustment of CTC     isolation protocols, the investigator are willing to isolate CTCs and immune cells at a     single blood drawing at the same time. A prospective trial will be conducted to elucidate the     roles of PD-1 expression lymphocytes and CTC numbers on the clinical outcomes of HNSCC     patients.   "
66093|NCT02420587|"     The goal of this clinical research study is learn how AMG208 may help to control prostate     cancer that has spread to the bone. The safety of the drug will also be studied.   "
66196|NCT02419248|"     Check the safety under normal conditions of use through the verification of emergence signs     of irritability and sensitisation of the genital mucosa.   "
66094|NCT02420574|"     Infections with soil-transmitted helminthes (STH) occur throughout the developing world and     remain a major public health problem in the poorest communities. Preventive chemotherapy (PC)     programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the     drugs of choice for STH - are administered at the population level, is the main strategy for     STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK)     (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In addition to     this, there are a wide variety of ALB and MEB tablets available on the local market. Although     little is known about the quality of anthelmintics sold for human use, several publications     have reported variability in the quality of generic anthelmintics used in veterinary     medicine. The main objective of the present study is to compare the efficacy of two ALB     brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX     (India, Cipla)   "
66095|NCT02420561|"     The study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug     use and depression symptoms, improve functional status and promote appropriate health     services utilization, in a sample of 300 adults seeking treatment for depression who also     report hazardous drinking or drug use with depression.   "
66096|NCT02420548|"     The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the     factors that contribute to the behaviors and health of teen girls, such as girl's     friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about     how to make healthy choices. This study will inform us on ways to help teen girls engage in     safe and healthy relationships and adjustment.   "
66097|NCT02420535|"     Behavioral symptoms that commonly occur with dementia are associated with increased health     care utilization and can lead to challenges for the person living with dementia and their     caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what     triggers them, and to learn how to use proven, practical medication-free strategies to     prevent and manage the behaviors. The purpose of this study is to develop and test the     WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps     them to assess, manage and track behavioral symptoms and their contributing factors (e.g.,     pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free     behavior management. This study is a collaboration between researchers at the University of     Michigan and Johns Hopkins University.   "
66098|NCT02420522|"     This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation     (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The main     objective of this study is to investigate the ability of rTMS to produce cognitive     improvement in individuals with MCI. A secondary objective is to determine whether     individuals with MCI following mild brain trauma respond differently to rTMS treatment     compared to individuals with non-trauma related MCI.      All participants will undergo both active and sham (placebo) rTMS treatment. Cognitive and     psychological assessments will be administered before and after each week of rTMS therapy,     for both active and sham conditions. Cognitive testing will include verbal, semantic, logic,     visual, conceptual, and memory tasks.   "
66099|NCT02420509|"     The purpose of this study is to find out if postoperative chemotherapy in patients with     high-grade appendix cancer after surgery improves outcomes.      The postoperative chemotherapy will consist of 5-FU (with leucovorin) or capecitabine with     bevacizumab. These drugs are approved for use in people with colon cancer, and they are used     at UCSD for some patients with appendix cancer.      The purpose of this study is to explore the safety and efficacy of the postoperative     chemotherapy treatment on cancer.   "
66101|NCT02420483|"     The authors to measure passive tidal volumes generated during external chest compressions in     order to determine whether chest compressions alone without any mechanical ventilatory     support in cardiopulmonary resuscitation can provide adequate ventilation. The authors will     study 25 volunteers who meet the following inclusion criteria: age 18-55 years, ASA I-II,     candidates for surgical operation, who will receive general anesthesia. Patients who will be     operated in the chest, who present musculoskeletal diseases, cardiopulmonary or vascular     acute or chronic diseases, who had history of pneumothorax, of thromboembolism, osteoporosis,     menopause, history of current rib or sternal or clavicle fractures, will be excluded. All     eligible patients will enter the study and will receive general anesthesia and intubation     according to treating doctors' decision.      Patients will be ventilated mechanically for 5 minutes to establish stable conditions. A     pneumotachograph will be then connected to the ventilatory circuit so that respiratory     efforts (volume, airway pressure and flow) can be continuously monitored at real time.      An esophageal catheter will be then inserted to monitor esophageal pressures and to provide     data for lung mechanics calculation. Following the above procedures and before any surgical     procedure, chest compressions will be performed to the patient by a senior anesthesiologist     according to ERC guidelines of 2010 for 30 seconds.      Following chest compressions, patients will be evaluated for possible complications and after     the establishment of stable conditions surgical procedures will follow. After the end of the     surgical operation clinical and chest ultrasound evaluation will be performed.      Written inform consent will be obtained by all patients before procedures.   "
66102|NCT02420470|"     Diabetes( mainly type II diabetes )lead to the central nervous system (CNS) function     impairment, especially the mild cognitive impairment that increased the risk of progression     to dementia.The primary objectives are defined according to a hierarchical design: i) to     tailor and apply multi-parametric, functional MRI techniques to identify cerebral     abnormalities (cerebral biomarkers) in type 2 diabetes mellitus and prodromal diabetes     mellitus ; ii) to assess whether these cerebral biomarkers are associated with cognitive     decrements;iii) to follow up with the putative prediabetic condition patients to verify     whether they can transform into diabetes.   "
66103|NCT02420457|"     The investigators are assessing the validity of fitness devices as surrogate measures of     chronic pain survey outcomes.   "
66104|NCT02420444|"     70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized     to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose     (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and     followed through Study Day 259.   "
68563|NCT02387294|"     Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent,     seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children     and Adolescents.   "
66105|NCT02420431|"     Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and     quality of life, and reduce the risk of further cardiac events. Depression and anxiety     (distress) are common among CR patients: 37% of patents have significant anxiety and/or     depressive symptoms. Distressed patients are at greater risk of death, further cardiac events     and poorer quality of life than those without distress and they use more healthcare.     Available drug and psychological treatments have only small effects on distress and quality     of life, and no effects on physical health. Therefore, it is essential that more effective     treatments for depression and anxiety are integrated into CR services. Extensive evidence     shows that a particular style of thinking dominated by rumination (dwelling on the past) and     worry maintains emotional distress. A psychological intervention (metacognitive therapy) that     reduces this style of thinking alleviates depression and anxiety in mental health settings.     The investigators aim to conduct a pilot trial of the group intervention and in work stream 2     the investigators will undertake a full-scale trial to evaluate whether adding the group     intervention to standard CR is more effective at alleviating anxiety and depression than     standard CR alone.   "
66106|NCT02420418|"     Background: . Bipolar disorders and tobacco use disorder are top of the causes of disability     and mortality worldwide Objective: The aim of this study was to evaluate N-acetyl-cysteine     (NAC) as an adjunctive treatment in patients with bipolar .disorders and tobacco use disorder     (TUD)      , to determine whether NAC reduces alterations in biomarkers of inflammatory and oxidative     stress Methods: This study will be conducted as a double-blind, randomized, placebo     controlles add NAC or placebo for .bipolar disorders and tobacco use disorder at Londrina     State University, Brazil.   "
66107|NCT02420405|"     The objective of the study was to compare the value of routine gene testing and     next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by     endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge     of how many EBUS-TBNA samples were adequate for NGS.   "
66108|NCT02420392|"     To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta     cell.   "
66109|NCT02420379|"     This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics     of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable     to exon 51 skipping.   "
66110|NCT02420366|"     A multi-center, retrospective study of cases of serious bacterial infections including     complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired     Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia     caused by Carbapenem-Resistant Enterobacteriaceae (CRE)   "
66111|NCT02420353|"     Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries     that occur in physically active individuals. Despite advances in minimally invasive surgical     reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength     can persist even after patients return to full activity and can place them at considerable     risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic     interventions to prevent muscle atrophy is needed to advance the care of patients who suffer     from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an     important role in promoting muscle growth and protecting muscle from atrophy. While GH     therapy has shown promise in protecting immobilized muscle from various models of disuse     atrophy, it remains unknown whether GH can help to restore strength and protect against the     loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe     return to play of patients that suffer ACL tears, and help to prevent the long-term OA and     reduction in quality of life that occur after these traumatic knee injuries.   "
66115|NCT02420301|"     Objective: To study the effects of self-administered exercises based on tuina techniques on     the pain intensity caused by playing related musculoskeletal disorders (PRMD) of professional     orchestra musicians, using numeric visual scale (NVS).      Method: The investigators performed a prospective, controlled, single-blinded, randomized     study with musicians suffering from PRMD. n= 69 musicians were randomly distributed into the     experimental and into the control group. After an individual diagnostic assessment, specific     tuina self-administered exercises were developed and taught to the participants. Musicians     were instructed (educated) to repeat the exercises every day during 3 weeks. Pain intensity     was measured by NVS before the intervention and after the 1st, 3rd, 5th, 10th, 15th and 20th     days of self-exercising. The procedure was the same for the control group, however the Tuina     exercises were executed in non-acupuncture points   "
66116|NCT02420288|"     The aim of this study is to examine the effect of a supervised physical exercise program     during pregnancy on fetoplacental growth.   "
66117|NCT02420275|"     After a brain injury (BI) , patients complain in particular about sequel fatigue. This     symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of     life, reeducation and occupational reintegration, and persists often at a distance of the     accident. The investigators' hypothesis is that patients who presented a severe BI could     benefit from a treatment by withe blue enriched bright light in order to improve fatigue and     quality of life.   "
66118|NCT02420262|"     This trial is conducted globally. The aim of this trial is to compare efficacy and safety of     insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with     metformin in subjects with type 2 diabetes mellitus.   "
66146|NCT02419898|"     The aim of this feasibility study is to test recruitment of participants into Phase 1 of the     study and then the re-recruitment and retention of participants in Phase 2 of the study. The     investigators will also be assessing the acceptability of recruitment strategy and data     collection to participants.      The effect of pre-pregnancy factors (biophysical, genetic, socioeconomic, behavioural and     psychological) on obstetric, cardiovascular, socioeconomic, behavioural and psychological     outcomes will all be examined.   "
66173|NCT02419547|"     This research study is being done to see whether general anesthesia (GA) affects our ability     to start ventricular tachycardia (VT) during an VT ablation procedure.      Data collected during this research study will help electrophysiologists and     anesthesiologists to make the best decisions about the best anesthetic conditions to use to     perform VT ablations.      This research study is a pilot study. Pilot studies are done on a small group of subjects     to learn if a larger study would be useful.   "
66119|NCT02420249|"     Objectives: (1) To investigate the effects of Qigong training on upper limb oedema,     circulatory status, shoulder flexibility and muscular strength, body balance, and quality of     life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the relationship     between the impairment outcomes and QOL outcomes.      Hypothesis: (1) The experimental participants will have less impairment and a better QOL     after Qigong training compared with the no-training control group; and (2) the impairment     parameters will be related to the QOL indexes in the Qigong participants.      Design and subjects: This will be a prospective, randomised, single-blinded controlled trial.     Approximately 60 breast cancer survivors will be randomly assigned to either the Qigong     training group (n~30) or control group (n~30).      Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal     Qigong training for 3 months with two supervised 1-hour sessions per week.      Main outcome measures: The primary outcome measures are upper limb circumference, arterial     blood flow velocities and resistance index, shoulder joint passive range of motion, muscular     strength (peak force) and body balance. The secondary outcome measure is quality of life as     measured by the Functional Assessment of Cancer Therapy - Breast scale.      Data analysis: Data will be analysed via repeated-measures analysis of variance followed by     post-hoc tests (α = 0.05).      Expected results: The investigators pilot studies produced encouraging results on the     efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors.     Therefore, the investigators expect that participants in the Qigong group will have fewer     upper limb impairments and a better quality of life after Qigong training. If the results are     positive, this Qigong training regime is readily transferrable to clinical practice, and     could have positive socioeconomic effects such as reduced healthcare costs.   "
66120|NCT02420236|"     The purpose of this study is to investigate if high-intensity resistance training can induce     additional beneficial effects, for patients with moderate to severe long term pain in the low     back, when added to a multidisciplinary treatment program.   "
66121|NCT02420223|"     This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic     antagonist propranolol is effective in decreasing gene expression of stress-mediated     beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic     stem cell transplant (HCT) for multiple myeloma.   "
66122|NCT02420210|"     This phase II trial studies how well bendamustine hydrochloride, obinutuzumab, and     dexamethasone work in treating older patients with diffuse large B-cell lymphoma. Drugs used     in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways     to stop the growth of cancer cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab,     may find cancer cells and help kill them. Giving bendamustine hydrochloride, obinutuzumab,     and dexamethasone may kill more cancer cells.   "
66123|NCT02420197|"     The purpose of this study is to investigate if high-intensity resistance training can induce     additional beneficial effects, for patients with moderate to severe long term pain in the     neck, when added to a multidisciplinary treatment program.   "
66124|NCT02420184|"     This study is being conducted to determine whether treatment of obstructive sleep apnea (OSA)     in patients with chronic kidney disease (CKD) improves kidney function. Half of the     participants will receive continuous positive airway pressure (CPAP) treatment for their OSA     in addition to their regular CKD treatment, while the other half will only receive their     regular CKD treatment.   "
66125|NCT02420171|"     Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In     Vitro culture and detect the the effect upon embryo quality and implantation potential.   "
66126|NCT02420158|"     This pilot study plan to investigate the sympathovagal balance in women affected by Irritable     Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve     electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal     permeability, systemic and local inflammation), symptoms and quality of life.      The safety of the electrical stimulation of the left vagal nerve will also be evaluated.      Ten women, age between 18 and 60, will be included.   "
66127|NCT02420145|"     The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention     compared to no specific intervention on weight-related outcomes, well-being, and health     behaviour in 60 females with abdominal obesity.   "
66128|NCT02420132|"     This pilot study will evaluate home vision testing using a mobile medical application in     participants with diabetic macular edema (DME) or neovascular age-related macula degeneration     (nAMD) who receive intravitreal ranibizumab therapy. In the main, decentralized study,     participants will be recruited via digital media, advocacy groups, or through their own     ophthalmologist. The traditional substudy will evaluate the association between visual acuity     and anatomical markers of disease status determined using clinical gold standard     assessments (certified Early Treatment Diabetic Retinopathy Study [ETDRS] protocol visual     acuity and macula optical coherence tomography [OCT]) and the results of home vision testing     using the myVisionTrack^TM (mVT) application.   "
66211|NCT02419040|"     The purpose of this study is to determine whether the combination of removal of the     calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus     tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is     more effective than corticosteroid or sham injection alone.   "
66129|NCT02420119|"     Intravenous iron therapy is common and effective, with few side effects. Two formulations are     used, venofer or iron sucrose and ferrlecit, or ferric gluconate.      The association between intravenous iron use and decrease in serum phosphorus and vitamin D     levels, with increased fractional excretion of phosphorus, has been observed with older iron     preparations, such as saccharated ferric oxide. However, hypophosphatemia and osteomalacia     have been reported with iron carboxymaltose, a newer iron formulation. There is no     information in the literature about phosphorus and vitamin D levels after treatment with     venofer or ferrlecit. We intend to check phosphorus and vitamin D serum levels in our     patients prior to and after treatment with these iron formulations.   "
66130|NCT02420106|"     The purpose of the proposed research is to determine if Osteopathic manipulative medicine     (OMM) used alone or in combination with the standard treatment of botulinum toxin     intramuscular injections improves motor function and quality of life amongst people with     cervical (neck) dystonia.   "
66131|NCT02420093|"     The aim of this study is to examine the clinical effects of supporting the human pelvis in a     neutral sitting position in subjects with Low Back Pain over a 3-week period. The neutral     sitting posture will be supported by a portable and adjustable pelvic support device or     pelvic support assembly per US Patent number US 8,857,906 B2 that is used in the seat of     the user's desk chair.   "
66132|NCT02420080|"     The objective is data collection to determine background rates of adenovirus (AdV)     progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.   "
66133|NCT02420067|"     The purpose of the study is to investigate how best to screen for Endolymphatic sac tumors     (ELSTs) in von Hippel-Lindau (vHL) patients in order to diagnose the ELSTs while they are     still small so that hearing loss can be prevented.      Up to 16% of vHL patients are known to develop endolymphatic sac tumors in the inner ear that     can cause permanent hearing loss. However, the ELSTs are often not found before hearing loss     has already occurred. The challenge for doctors is to diagnose the ELSTs at early stages     before they cause often irreversible deafness. In order to find ELSTs before they cause     hearing loss, it is important to screen for the tumors prophylactically, that is screen all     vHL patients regardless of whether or not they have symptoms.      Who can join? Persons diagnosed with vHL who are at least 15 years old. The investigators     include patients WITH OR WITHOUT a diagnosed ELST.      What does it involve? You need to have a hearing test and an MRI of the brain, where the     inner ear can be seen, most vHL patients have already had this done as part of their     surveillance program.      Participants will be asked to participate in follow up examinations (hearing test and/or MRI     of the brain) after 2, 5, and 10 years.      How can I join? A doctor has to be responsible for the study in each country where vHL     patients participates.      Ask the doctor who manages your vHL examinations to contact us or contact us yourself and the     investigators will help you find a doctor in your country who will participate in the study.   "
66134|NCT02420054|"     The purpose of the study is to determine the effect of intermittent fasting on insulin     secretion and insulin sensitivity in skeletal muscle and fat distribution.   "
66135|NCT02420041|"     The purpose of this research project is to compare two different techniques for performing an     injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal     of the study is to determine if one technique is better than the other with respect to     improvement in a patient's pain, function, and his or her satisfaction. Additionally, the     investigators want to determine if one technique is quicker and more efficient than the     other.   "
66136|NCT02420028|"     A prospective, single-center, open-label, randomized controlled trial to assess the safety     and efficacy of the OptiVein IV Catheter in an oncology population. The study hypothesis is     that OptiVein IV Catheter use will be superior to the control in successful venous access     after first attempt.   "
66137|NCT02420015|"     This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective     at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment     that combines mobile technology with behavioral strategies, counseling, and medications.   "
66138|NCT02420002|"     This is a therapeutic, randomized, single center, two parallel-arm trial comparing pain     control via MEOPA (equimolar mixture of nitrous oxide and oxygen) in one arm versus     Hypnosis + MEOPA if needed in the second arm.      The primary objective is to compare the two study arms in terms of efficacity for pain     control according to the FLACC (Face Legs Activity Cry Consolability Observational Tool)     behavioural scale.   "
66139|NCT02419989|"     No nontuberculosis mycobacteria (NTM) treatment protocol has been validated in the setting of     cystic fibrosis (CF). This trial tests the feasibility of a standardized treatment algorithm     for confirmed disease by either M. avium complex or the M. abscessus complex that is also     based on forthcoming guidelines from the CF Foundation (CFF) and the European CF Society     (ECFS). The primary endpoint is 12 months of negative NTM cultures following completion of     therapy.      The investigators' near-term goal is to validate both protocols by extending the trial to 5     additional CF Centers. The long-term goal is to make the validated protocols available to the     entire CFF Care Center Network.   "
66140|NCT02419976|"     The investigators will study a noninvasive no risk process by which the investigators can     quickly screen and assess for fasting and non-fasting states in individuals scheduled for     routine endoscopy.   "
66141|NCT02419963|"     Microbiota from fecal samples from IBS-D patients, in combination with vitamin D     supplementation added to our 3-D immunocompetent intestinal models will establish a high     fidelity disease model to achieve our long-term goal to understand the relationship between     gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could     ultimately be used as a testing platform for treatment and prevention.   "
66142|NCT02419950|"     Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was     to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of     mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients     were studied for pain interfering with sexual activety. The hyopthesis is that fixation     causes pain.   "
66245|NCT02418585|"     The purpose of this study is to compare the efficacy and safety of switching     treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which     they have not responded) to either intranasal esketamine plus a new oral antidepressant or     switching to a new oral antidepressant plus intranasal placebo.   "
66143|NCT02419937|"     Introduction: Interleukin 6 (IL-6) is a cytokine that has a pro-inflammatory effect on the     immune system. In acute MI IL-6 levels rapidly increase in response to ischemia and     inflammation. Tocilizumab is a humanized monoclonal antibody against the interleukin-6     receptor (IL-6R). The use of tocilizumab within the first 24 hours of admission for acute MI     could reduce 30 day mortality.      Methods: This randomized, placebo controlled trial will assign subjects within 24 hours of     admission to treatment with either 162 mg of tocilizumab subcutaneously once or placebo in     addition to usual pharmacologic and interventional standard of care for acute MI (ST segment     elevation MI or non-ST segment elevation MI).      Outcomes: The primary outcome is difference in 30 day (plus/minus 5 days) occurrence of major     adverse cardiac events (as defined later in this protocol) between placebo and Tocilizumab     treated groups. Secondary outcomes to be assessed include length of hospitalization,     readmission rates by day 30, CRP levels at 0 hours, 24 hours, 48 hours, and 30 days following     treatment, and safety of Tocilizumab with focus on rates of known side effects.   "
66144|NCT02419924|"     Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory     constipation due to pelvic floor laxity and excessive perineal descent by means of a modified     toilet seat, known as the Bottom's Up.   "
66145|NCT02419911|"     This is a post market, prospective, comparison study of the use of the FloShield Air System     versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.   "
66147|NCT02419885|"     Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of     the hands and have an aesthetic function. Fingertip injuries are defined as injuries     occurring distal to the insertion of the flexor and extensor tendons. These injuries are one     of the most common trauma injuries presented in acute care settings, accounting for     approximately 4.8 million emergency department visits per year in the United States.(1)     Fingertip amputations may not constitute the majority among these fingertip injuries but can     have a complex spectrum of injury. In these cases, the reconstruction methodologies focus on     preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail     structure, achieving a well-contoured and painless fingertip, and restoring durable and     sensate skin.      There are so many factor that influence the result of composite graft in distal finger tip     amputation. Investigators will collected the data including the size of amputee , shape,     level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation     procedures.   "
66148|NCT02419872|"     The study is to evaluate the percentage of patients with asthma or COPD achieving disease     control   "
66149|NCT02419859|"     The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported     outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2     diabetes mellitus (T2DM).   "
66150|NCT02419846|"     This clinical trial studies an informed decision making intervention of screening for     prostate cancer in predominantly African American participants. It also evaluates     participants' knowledge about prostate cancer screening and to improve understanding. Using     decision aids such as culturally sensitive written material, verbal information, and videos     to educate patients about screening may increase patient participation and knowledge. This     may increase confidence in participants' decisions. Raising awareness about prostate cancer     in the communities may increase the participants' willingness to be screened for prostate     cancer once they have learned about it.   "
66151|NCT02419833|"     In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI),     previous studies have indicated that routine invasive treatment confers more benefit as     compared to selective invasive approach. The benefits of routine invasive coronary     intervention have been the most evident in patients with higher baseline risk profile.     However, the question of optimal timing of routine invasive intervention remains unsolved.      Immediate invasive intervention early after admission for non-STEMI may limit myocardial     necrosis by securing the patency of the culprit coronary artery. Nevertheless, several     previous studies reported higher levels of biomarkers of myocardial injury in patients     undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients     may thus amount to whether the risk of intervening on an unstable plaque is greater than the     risk of new ischemic events while waiting for the invasive procedure.      The purpose of the present study is to compare effects of immediate coronary intervention,     within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission,     in patients witn non-STEMI.   "
66152|NCT02419820|"     Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral     Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791     (Temanogrel) Co-administered with Aspirin and Clopidogrel.   "
66153|NCT02419807|"     This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical     stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or     mastectomy and planned axillary sentinel node biopsy procedure. Patients will undergo     lymphatic mapping with technetium Tc-99m (99mTc) sulfur colloid in accordance with routine     clinical practice. Injections of 99mTc sulfur colloid will take place the afternoon prior to     planned next morning surgery or on the morning of surgery. Patients will undergo     lymphoscintigraphy in accordance with standard clinical practice.      Immediately prior to operation, after the induction of anesthesia in the operating room, up     to 1cc of 0.5% indocyanine green (ICG) solution will be injected subdermally close to the     tumor or into the subareolar region after disinfection of the breast skin. ICG movement will     be facilitated by manual massage and monitored with fluorescence imaging. ICG fluorescence     will be elicited and detected by Photodynamic Eye (PDE) camera. The lymphatic drainage, made     evident by the fluorescent dye, will be monitored in real time on a monitor. The fluorescence     will be followed towards the armpit region (axilla) and time for the fluorescence to reach     the axilla will be recorded. Following standard practice, an incision will be made in the     armpit region. Fluorescent lymph nodes (ICG positive) will be localized and removed and     analyzed by a pathologist. Node removal will continue until no residual fluorescence is     visible in the axilla. Removed nodes will be tested for radioactivity using a standard     gamma-detecting probe and the counts per minute will be recorded. Finally, the armpit region     will be inspected with the gamma probe to determine if there are any residual radioactive     nodes. Residual sentinel nodes (the first node to receive lymph from a tumor) will be     removed. For the purposes of this study, the sentinel status of a node will be defined as     being flagged as sentinel by either one or both of the ICG or 99mTc methods. The goal of the     project is to confirm that axillary lymphatic mapping with ICG leads to similar nodes being     labeled as sentinel as lymphatic mapping with 99mTc-labeled radiotracer.   "
66156|NCT02419768|"     Parkinson's disease (PD) is one of the most common neurodegenerative disorders. The     parkinsonian gait is characterized by reducted stride length and gait speed, postural     disorders (with a high risk of falling) and a modification of stride duration variability.     This variability can be assessed by its magnitude (SD and CV) and its temporal organization     (long-range autocorrelations). Healthy human gait presents with an interdependency between     consecutive cycles that can span over hundreds of strides (long-range autocorrelations).     Numerous observations plead for a relation between long-range autocorrelations and functional     abilities of the system. Complementary to drugs, rehabilitation becomes an important way to     treat PD.      The aim of our study is to assess by a controlled, randomized, single blinded clinical study,     the effect of physical exercise on stride duration variability, neurological impairments and     walking abilities of parkinsonian patients.      Physical exercise program will include 30 sessions spread over 15 weeks following the     guidelines. Long-range correlations analysis, including the study of Hurst and α exponents,     will be performed on a minimum of 512 consecutive cycles. Finally, the functional assessment     of the parkinsonian patient will be done according to International Classification of     Functioning Disability and Health (ICF).   "
66168|NCT02419612|"     This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin,     in addition to metformin, results in better glycemic control, as measured by HbA1c, over a     treatment period of 52 weeks, compared to the addition of glimepiride to metformin in     subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin     Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in     co-administration with dapagliflozin, added to current background therapy with metformin     compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week     52.   "
66169|NCT02419599|"     This study is a pilot trial investigating the effects of a high energy drink for children, in     comparison to standard energy drink for children.   "
66157|NCT02419755|"     This study will test the safety and effectiveness of adding bortezomib and vorinostat to     other chemotherapy drugs commonly used to treat relapsed or refractory leukemia. Both drugs     have been approved by the Food and Drug Administration (FDA) to treat other cancers in     adults, but they have not yet been approved tor treatment younger patients with leukemia.      PRIMARY OBJECTIVE        -  To estimate the overall response rate of patients with MLL rearranged (MLLr) hematologic          malignancies receiving bortezomib and vorinostat in combination with a chemotherapy          backbone.      SECONDARY OBJECTIVES        -  Estimate event-free and overall-survival.        -  Describe toxicities experienced by participants during treatment.      OTHER PRESPECIFIED OBJECTIVES        -  To identify all genomic lesions by comprehensive whole genome, exome and transcriptome          sequencing on all patients.        -  To compare minimal residual disease (MRD) results by three modalities: flow cytometry,          polymerase chain reaction (PCR) and deep sequencing.   "
66158|NCT02419742|"     This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study     to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor     receptor 2 protein (HER2)-positive node positive or high risk node negative breast cancer     participants with regimen consisting of doxorubicin and cyclophosphamide followed by either     paclitaxel or docetaxel (AC-TH Regimen) or a regimen consisting of docetaxel and carboplatin     (TCH Regimen) in Indian population.   "
66159|NCT02419729|"     Forty-five women will be included in a double-blind randomized trial in order to compare     fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments     for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2     laser treatment.   "
66160|NCT02419716|"     This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at     3 years in average risk patients.   "
66161|NCT02419703|"     Registry collecting data on use of The STAR™ Tumor Ablation System.   "
66162|NCT02419690|"     This study aims to use a text messaging intervention to prevent unintended teen pregnancy and     transmission of sexually transmitted disease. The study will be informed by a formative     qualitative phase (February 2014 - January 2015) which will include individual qualitative     interviews and focus group with teens to elucidate and explore the barriers to effective     contraceptive use and sexually transmitted disease (STD) prevention and to obtain feedback on     the developed intervention. The second efficacy phase will randomize subjects to the texting     intervention or to usual care.   "
66163|NCT02419677|"     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with     colorectal cancer liver metastases (CRCLM).   "
66164|NCT02419664|"     Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of     pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of     administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the     detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer     expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised     case-control study with open design with GA-PET before and after pituitary surgery in     patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's'     disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and     non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria:     Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone     (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with     somatostatin analogues (SSA) or dopamine agonists.      Exclusion criteria: Patient who may not attend to the protocol according to the investigators     opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of     gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known     or suspected allergy to the trial product or related products.      Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid     infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer     uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions     of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3     years later   "
66165|NCT02419651|"     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in     reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in     Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 mg     1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue     scale   "
66166|NCT02419638|"     To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week     (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or     enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who     are prescribed these medications and receive a 6 month MRI scan as standard of care.   "
66167|NCT02419625|"     Hepatitis E virus is a single-stranded positive-sense RNA virus with genome of approximately     7.2kb in length. The HEV genome is capped at the 5' end followed by a small untranslated     region of 27 nucleotides and polyadenalated at the 3' end preceded by another UTR of 65     nucleotides . HEV has three open reading frames: ORF1, ORF2 and ORF3 that encode structural     and non- structural proteins. ORF1 is the largest one, approximately 5,000 nt in length,     located at the 5 ' end and encodes important proteins for the replication process     (methyltransferase, papain-like cysteine protease, helicase, and RNA-dependent RNA     polymerase). A noncoding, hypervariable region within ORF1 displays substantial genetic     diversity; this region seems to modulate the efficiency of HEV replication. Notably, the     differences in the genome size among different HEV strains are confined mainly to this region     .ORF2 is located at the 3' end, encodes structural capsid proteins of 660 amino acids and     contains three potential glycosylation sites. The ORF2 protein contains multiple immunogenic     sites and neutralizing antibodies are directed against it al., .The essential region in the     protein for immunogenicity is 452aa-617aa and the neutralizing epitopes have recently been     shown to be conformational .ORF3 is located between the other two reading frames and encodes     a small phosphoprotein of 123 amino acids. Its exact function has not been yet determined,     however, multiple functions have been proposed. It is thought to interact with cellular     mitogen-activated protein kinase phosphatase and other extracellular kinases, promoting cell     survival through activation of intracellular signaling pathways .Moreover, the binding of the     ORF3 encoded protein to host-specific proteins seems to influence the pathogenesis of HEV     infections .A schematic drawing of the HEV genome is described in Figure 1 .   "
66170|NCT02419586|"     Gum chewing group will have less ileus and early resume of bowel motion than control group.   "
66177|NCT02419495|"     Objectives:      Primary Objective:      To establish the safety and tolerability of Selinexor when given in combination with standard     chemotherapy regimens.      Secondary Objectives:      To determine disease control and progression free survival of Selinexor administered with     standard chemotherapy treatments.      Exploratory Objectives:      To determine the correlation of translational biomarkers To compare serial assessment of     mutation status in biopsies obtained at baseline and progression after clinical response to     combination therapy   "
66178|NCT02419482|"     The aim is to investigate whether 16 weeks of high intensity interval training, followed by     36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic     Ovary Syndrome (PCOS) compared with a non-exercising control group.   "
66179|NCT02419469|"     The goal of this clinical research study is to learn if a chemotherapy combination called     augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab,     can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety     of these drug combinations will also be studied.      Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG     asparaginase, and methotrexate.   "
66180|NCT02419456|"     Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to     prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs     containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176)     and MK-2048, in healthy, HIV-uninfected women.   "
66181|NCT02419443|"     A common source of morbidity after IHR is chronic groin pain(CGP), usually defined as pain     lasting longer than 3 months. Gabapentin is an anticonvulsant that is also of benefit in the     treatment of neuropathic pain. We propose a randomized, double-blind, placebo controlled     study of the effect of gabapentin on CGP after IHR. Their pain will be assessed with a visual     analogue scale. For those reporting pain, the need for pain medication, or other treatment,     and the effect of pain on their quality of life will be recorded.   "
66182|NCT02419430|"     The investigators aim to evaluate the Mindfulness Based Resilience Training (MBRT)     intervention for Mayo Clinic employees in order to provide evidence for improved ability to     cope with stress and decreased work-related burnout and stress-related symptoms as a result     of MBRT training. In addition, the investigators aim to compare the effects of MBRT +     smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback,     or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of     75 Mayo Clinic employees.   "
66183|NCT02419417|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and     pharmacodynamics of BMS-986158 in subjects with select advanced solid tumors.   "
66186|NCT02419378|"     Alemtuzumab is the active agent of a drug called Lemtrada®. In the European Union, Lemtrada®     is approved for the treatment of a particular form of multiple sclerosis (the so called     relapsing remitting form). The excellent efficacy of the drug justifies its administration     albeit a high risk of considerable side effects. In this context, so called secondary     (occurring after the administration of Lemtrada®) autoimmune diseases are of particular     importance. In these diseases the immune system acts against structures of the body itself;     the reasons are still unknown. Autoimmune diseases may even occur several years after     treatment with Lemtrada®. Therefore, patients who once received the drug need to undergo     intensive long term health monitoring.      This study aims to elucidate which mechanisms cause to the positive and negative effects of     Lemtrada®.      The study includes patients only, who suffer from multiple sclerosis and are indicated to be     treated with Lemtrada®. All patients receive the drug according to the official     recommendations.   "
66187|NCT02419365|"     The purpose of the international prospective PCD Patient Registry is to systematically     measure, survey and compare different aspects of PCD manifestation, course and treatment, to     provide data for epidemiological research and to identify special patient groups suitable for     multi-center trials.   "
66188|NCT02419352|"     Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after     both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of     this study is to examine the possible effect of the novel reversal agent sugammadex versus     neostigmine/ atropine combination on cognitive function of adult patients after elective     surgery during the early post operative period as well as at discharge.   "
66189|NCT02419339|"     Prospective multicenter observational study of early infancy ureteral reimplantation for     distal ureteral obstruction.      The study is an observation study since the investigators will not assign specific     interventions to the subjects of the study.      The purpose of the study is to describe the surgical outcomes of early infancy ureteral     reimplantation. Infants under 6 months of age with unilateral obstructed distal ureter, no     other urologic pathologic and a normal contralateral kidney who have been recommended a     ureteral reimplant by their pediatric urologist are eligible for the study. Patients that     consent for the study will be prospectively followed for 1 year to record the outcomes of the     surgery.   "
66190|NCT02419326|"     The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy     of a novel couple-based intervention for binge-eating disorder (BED).   "
66191|NCT02419313|"     The scientific aim of this study is to investigate the efficacy and safety of     incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson‟s disease. Our     hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases     the tremor amplitude and frequency leading to improvement of the patient‟s function.   "
66192|NCT02419300|"     Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of     conception after second trimester miscarriage to select who will benefit from surgical     evacuations or conservative management.   "
66193|NCT02419287|"     The purpose of this study is to determine the response and the duration of it in patients     affected by ALK+ lymphoma that are resistant or refractory to standard cytotoxic treatment     that will be treated with crizotinib.   "
66194|NCT02419274|"     Deep Phenotyping of adult asthma patients:        -  severity from mild to severe        -  both atopic and non-atopic        -  both childhood and adult onset        -  both smokers and non-smokers        -  corresponding pediatric cohort (Pediatric Arm of DZL All Age Asthma Cohort) with          equivalent SOPs regarding collection of biomaterial and clinical data incl. lung          function, further processing of biomaterial and further analyses   "
66197|NCT02419235|"     Refractory hypertension is defined as failure to reach goal blood pressure control in     patients who are adherent to full doses of the appropriate drug regime. Hypertension results     in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it     the number one attributable risk for death throughout the world. Conventional treatment     involves lifestyle modification and antihypertensive drug therapy; however blood pressure can     remain uncontrolled despite these treatment options. Previous studies have demonstrated a     reduction in blood pressure in adults with essential hypertension with the use of various     homoeopathic complexes. There has been no research done to date on the effect of the     homoeopathic combination of Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum     muriaticum 6cH and Scutellaria lateriflora 6cH in adults with refractory hypertension.      The aim of the study is to investigate the effect of a homoeopathic complex Amylenum nitrosum     6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH on blood     pressure in adults with refractory hypertension, by means of blood pressure readings.   "
66198|NCT02419222|"     This research project is a study designed to address both motor and cognitive changes after     stroke. Treatment for SN is elusive however there is support for prism adaptation treatment     (PAT). Therapists need to know more about the effects of this treatment and if it is feasible     in a group of stroke survivors with multiple lesions because these are the patients they are     treating in the clinical setting. Also, it has not been investigated that using PAT to     remediate SN will then as a result increase spontaneous UE movement of the weak limb.   "
66212|NCT02419027|"     A Multi-center, Randomized, Double-blinded, Placebo-controlled Human Study to Evaluate the     Efficacy and Safety of probiotic mixture(®GI Flora) in Subjects with Irritable Bowel     Syndrome.      Regimen: 6 probiotics mixture >10^9/D for 8 weeks      Primary variable: visual analogue scale(VAS) assessment for abdominal pain      Secondary variable:        1. change of VAS score for abdominal pain/discomfort after 4/8-week treatment        2. daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete          evacuation), flatulence , feces shape, frequency of bowel movements   "
66297|NCT02417909|"     Obesity is a major public heath issue. It may have various impacts on a patient's life by     causing psychological problems, altering a patient's quality of life,etc. These led to the     investigators' hypothesis which is examining the psychological dimensions of a teenager     suffering for obesity.   "
66199|NCT02419209|"     Low sexual desire, or decreased libido, is one of the most prevalent sexual complaints in     females. Menopause is defined as the physiologic cessation of menses brought on by a decrease     in ovarian function and is established once menses have been absent for at least twelve     months. Perimenopause refers to the period shortly before as well as the twelve months after     the last menstrual period. The duration of perimenopause varies greatly and signs and     symptoms usually begin appearing during a woman's forties. A longitudinal study conducted in     Seattle showed that women experienced a significant reduction in sexual desire during the     late perimenopausal and early postmenopausal stages, with the biggest decline in sexual     desire occurring from three years prior to two years after the final menstrual period.     Despite being a prevalent female complaint, currently no standard treatment for low sexual     desire exists. Homeopathy may offer a safe and effective solution for this common problem,     however limited research has been conducted to date.      The aim of this study is to explore the effect of individualised homeopathic treatment on low     sexual desire in perimenopausal females using detailed case studies, the desire and arousal     subscales of the Female Sexual Function Index (FSFI) as well as Item 13 of the Female Sexual     Distress Scale - Revised (FSDS-R).   "
66200|NCT02419196|"     Perioperative changes in regional ventilation by pulmonary electrical impedance tomography     and spirometry will be investigated in patients at risk for postoperative pulmonary     complications. Those patients undergo abdominal and limb operations. In a pilot study arm     electrical impedance tomography is tested in patients receiving osteosynthesis of serial rib     fractures.   "
66201|NCT02419183|"     The purpose of this study is to evaluate the psychometric properties of a Self-administered     Memory Screening Test with Automated Reporting (SAMSTAR) adapted from the Rey Auditory Verbal     Learning Test (RAVLT) in normal control (NC) participants and participants with Mild     Cognitive Impairment (MCI) against a standard version of the RAVLT test, administered by an     examiner under the same conditions.   "
66202|NCT02419170|"     The purpose of this research study is to study the safety and immune response of people who     receive a personalized dendritic cell vaccine with the intention of stimulating the immune     system to react to lung cancer cells.   "
66203|NCT02419157|"     The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical     lesions (NCCLs) restored with two self-etching adhesive systems applied with or without     selective enamel etching.   "
66204|NCT02419144|"     This study will test an intervention designed to change oral health norms and reduce     disparities in oral health among vulnerable adults residing in publicly funded senior housing     in Central Connecticut. The intervention model is based on Fishbein modified theory of     reasoned action operationalized through Adapted Motivational Interviewing and Practice to     Mastery. The intervention includes two components: 1) a face to face administration of the     Adapted Motivational Interviewing and Practice to Mastery, a participatory counseling model,     and 2) a targeted building level campaign consisting of three half-day oral health events     with skills development through practice to mastery to parallel the individual intervention,     all based on the study's conceptual model. The study uses a modified fractional factorial     design to evaluate the face to face and campaign components separately and in different     additive sequences. Six buildings will be paired in three dyads. The buildings in each dyad     will be randomized to either having the Adapted Motivational Interviewing and Practice to     Mastery intervention first followed by campaigns or to having the campaigns first followed by     Adapted Motivational Interviewing and Practice to Mastery. Seventy-five residents will be     recruited in each building for a total of 450 participants. There will be four assessments:        1. T0 will include a survey, oral hygiene skills assessment and clinical assessment of the          Gingival Index and Plaque Score. The survey will provide data on the conceptual domains          that are the target of the tailored intervention        2. T1 will follow the AMI-PM or CA+PM (depending on condition) and will include the survey,          oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque          Score. This assessment will occur 1-2 months after the initial intervention        3. T2 will follow the AMI-PM or CA+PM and will include the survey, oral hygiene skills          assessment and clinical assessment of the Gingival Index and Plaque Score. This          assessment will occur 6 months after the initial intervention        4. T3 will include oral hygiene skills assessment and clinical assessment of the Gingival          Index and Plaque Score. This will occur 15-18 months after study entry. We will use          general linear mixed models (GLMM) or general estimating equations (GEE), respectively,          to fit a model with intervention and period effects using the MIXED procedure in SAS.   "
66205|NCT02419131|"     The overall purpose of the study is to compare two talk therapies (Clinic-Based Cognitive     Behavioral Therapy and Cognitive Processing Therapy-Cognitive Only) for the treatment of     posttraumatic headache (PTHA) and co-morbid posttraumatic stress (PTS). The researchers hope     to learn if a non-medication, cognitive-behavioral treatment can result in noticeable     reductions in PTHA intensity/severity and frequency as well as PTS symptom severity.   "
66206|NCT02419118|"     Daratumumab is a new treatment for patients with myeloma. While many patients benefit from     this treatment some do not and the mechanism(s) of failure are poorly understood. This study     aims to clarify aspects of resistance to treatment with daratumumab in order to improve     patient outcomes in the future.   "
66207|NCT02419105|"     The overall purpose of this study is to test the individual and combined effect of     transdermal testosterone and/or Vitamin D in reducing fall risk and improve function in     pre-frail hypogonadal senior men.   "
66208|NCT02419092|"     UPDATED May 2016:      Originally the study design included investigation of the effects of the bioactive compound     resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having     OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the     investigators have found it necessary to descale the study design. Hence, we have     discontinued the resveratrol and CPAP intervention and will focus on the cross-sectional     investigation of metabolic changes in subjects with and without OSA and the effect of weight     loss after bariatric surgery on inflammation, OSA severity, metabolism and arterial     stiffness.      Obstructive sleep apnea (OSA) is a common disorder especially among obese individuals and     patients with type 2 diabetes. OSA is associated with an increased morbidity and mortality.      Continuous positive airway pressure (CPAP) is the standard treatment. Also weight loss is     known to reduce the severity of OSA, especially bariatric surgery has proven effective     because of the massive weight loss.      The investigators hypothesize that OSA via pro-inflammatory responses in various tissues     causes low-grade inflammation which ultimately induce the associated co-morbidities. The     investigators hypothesize that massive weight loss after bariatric surgery have beneficial     effects on severity of OSA, inflammatory status and improves insulin sensitivity.   "
66209|NCT02419066|"     Determine the level, patterns, and correlates of objectively measured ART adherence in early     and advanced-stage disease, among pregnant and non-pregnant individuals, to determine the     need and nature of interventions to support early ART adherence in Uganda and South Africa   "
66210|NCT02419053|"     The purpose of this study is to see if the surgical safety checklist is associated with a     reduction in perioperative complications for children undergoing surgery in Ontario, Canada.   "
66238|NCT02418689|"     The purpose of this study is to evaluate the efficacy and safety of novel pan-HER inhibitor,     NOV120101 (Poziotinib), in HER2-overexpressed recurrent stage IV breast cancer patients who     received at least 2 prior HER2-directed regimens.   "
66239|NCT02418676|"     The coprecipitation method was used to prepare hydroxypropyl-beta-cyclodextrin complexed with     insulin (HPβCD-I) by mixing insulin with hydroxypropyl-beta-cyclodextrin (HPβCD) in the molar     ratio of 1:5 with the addition of 10 mL of purified water for every 100 mg of the complex.     After complete dissolution of the material, the mixture was stirred for 30 min at room     temperature (25°C), then left to rest for 60 min and lyophilized.      The gel was prepared by dispersing the Carbopol 940® polymer in a known amount of purified     water. Under mild heating the methylparaben (0.02%, w/v), propylparaben (0.01%, w/v) and     propylene glycol were dissolved and incorporated in the dispersion of Carbopol 940® and left     to rest for a period of 12h. After this time, the prepared gel was stirred and pH corrected     to a range of 5.0 to 7.0 with triethanolamine. A set amount of insulin and the HPβCD-I     complex were incorporated into the control gel for the preparation of other formulations.      A randomized, double-blind, prospective clinical trial was conducted from March 2013 to April     2014 at the Hospital Universitário Regional de Maringá (HUM), Paraná, Brazil, in order to     determine the safety and efficacy of gel in patients hospitalized in the Intensive Care Unit.      Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded     from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with     little tissue loss, and allow easy visualization of healing.      A letter of free and informed consent was obtained. The study was conducted with each patient     for a period of 15 days.      The volunteers were divided equally into three groups A, B and C, with each group being     formed by five volunteers (n=5). Group A was randomly selected for treatment with gel with     HPβCD-I complex, group B for treatment with gel with insulin, and group C with the control     gel.      Blood glucose tests were performed in order to assess whether the insulin complexed or     otherwise with HPβCD could cause an increase in the rate of insulin in the blood in patients,     leading to hypoglycemia.      An identical standardized procedure for gel placement was used for all patients. Initially,     the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was     measured and photographed, as the ruler included the date and the initials of the patient.     After measuring, a quantity of 5 grams of gel was placed on the pressure ulcer and covered     with sterile gauze and a transparent film.      The curative was changed once a day during the treatment period, unless there was leakage of     fluid, contamination, or signs of infection. Every three days the pressure ulcers of all     patients were measured and photographed again, resulting in a total of six measurements per     patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and     any kind of irritation. At the end of this stage, the properly gathered study data was     interpreted using the analysis software Mobile Wound Analyzer® (MOWA).      Data was evaluated by variance analysis (ANOVA), and means were compared with the Tukey test     (p < 0.05) using the software Statistica 8.0/2008 (Stat Soft Inc., Tulsa, USA).      Mixed model repeated measures methodology with some covariance structures was adopted for     statistical analysis of the clinical trial (p < 0.05). The Statistical Analysis System (SAS)     for Windows, version 9.3 (SAS Inc., Chicago, IL) program was used for statistical analysis.   "
66213|NCT02419014|"     The purpose of this study is to assess the feasibility and effectiveness of Cranial     Electrical Stimulation (CES) therapy in treating symptoms of Restless Legs Syndrome (RLS).     Participants will be randomly assigned to one of three groups, a usual care (control group),     an active CES device group and a sham (inactive) CES device group. Those who are enrolled in     one of the device groups will not know which type of device they have (blinding). Those     enrolled in the usual care group and sham groups will ultimately have the option to use the     active device after they complete the study. Study length for participants is 8 weeks.   "
66214|NCT02419001|"     A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the     Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult     Subjects with a Functioning Ileostomy.   "
66215|NCT02418988|"     Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients'     poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance     to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter     chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC.     But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many     advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has     multiple anticancer functions and does not have any of the immune-inhibitory effects of     chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and     safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced     HCC.   "
66216|NCT02418975|"     Pre-operative weight loss can reduce the risk intra- and post-operative complications but no     optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets     (VLCDs) were proven to results in higher metabolic improvements in the short-term than     balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD     results in lower intra-and post-operative complications compared to a hypocaloric diet.     However, to achieve a optimal compliance in patients having experienced multiple dietary     intervention failures, administration of the intervention will be performed by the enteral     route using a naso-gastric feeding tube.   "
66217|NCT02418962|"     This is a single center, randomized, placebo-controlled, double-blind trial to assess the     safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI).      The study to be conducted in Baney District, Bioko Island, Equatorial Guinea (EG), will be to     establish whether three doses of the higher regimen - three doses of 2.7x10^5 PfSPZ of the     PfSPZ Vaccine administered at 8 week intervals - is as well-tolerated and efficacious in     malaria exposed African adults as the five dose regimens. Specifically, the trial will     address the following objectives: is the three dose regimen:        1. Safe and well tolerated in Equatoguinean (EG) adults.        2. As immunogenic in EG adults as is the five-dose regimen of 1.35x10^5 PfSPZ in Tanzanian          and U.S. adults or as three-, four- and five-dose regimens of 2.7x10^5 PfSPZ being          tested in Tanzanian, Malian and U.S. adults.      In addition, as an exploratory objective, the volunteers in the EG trial will be followed     longitudinally to measure the incidence of malaria during the initial six months following     immunization, providing a preliminary assessment of efficacy.   "
66218|NCT02418949|"     This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase     of recovery in which the combination of drug therapy (cyproheptadine) and active movement     practice (AMP) is used to encourage increased voluntary muscle control and strength.   "
66219|NCT02418936|"     The purpose of this study is to develop and applicate two new genetic deafness gene     diagnostic kit for Waardenburg syndrome and large vestibular aquduct syndrome.   "
66220|NCT02418923|"     This study compares the results of current standard coagulation measurement devices to the     Quantra System, a new device, using small amount of extra blood obtained during routine blood     draws in neurosurgery patients.   "
66221|NCT02418910|"     The goal of this project is to complete the development of a patient-centered software system     and mobile app to assist in managing bipolar disorder. In Phase I, the investigators     developed a novel computational tool known as KIOS. Based on concepts from nonlinear systems     (chaos) theory, KIOS tracks multiple interacting symptoms to determine the precise state of a     BD patient. Once the patient's state is identified and the trajectory of the patient is     established, KIOS produces advice specific to the patient's condition to help manage the     course of the disease. To demonstrate the usability of the software, KIOS was converted to an     online tool with mobile access. Twenty bipolar patients evaluated KIOS in a twelve week field     trial. No technical problems with the software were observed and results showed that patients     had significantly more reductions in symptom severity than increases. The development of this     innovative tool to help patients self- manage BD has the potential to have a profound impact     on public health and achieve significant commercial success.   "
66222|NCT02418897|"     This pilot study will evaluate for the presence of neuromuscular junction (NMJ) defect in     women with motor fatigue in multiple sclerosis by Single Fiber Electromyography (SFEMG) using     the concentric needle electrode.   "
66223|NCT02418884|"     This study is designed to validate the hypothesis that the treatment of rosuvastatin could     increase the score of Calcification of Coronary artery(CAC) density in coronary artery     disease(CAD) patients with diabetes mellitus.CAD patients with diabetes who confirmed CAC     will receive rosuvastatin (20mg/d) therapy for 24 months.   "
66224|NCT02418871|"     The objective of this study is to evaluate the clinical outcomes of an accommodating     intraocular lens (AIOL) designed to provide distance, intermediate, and near vision in     patients undergoing cataract extraction and intraocular lens implantation using an improved     injector system.   "
66225|NCT02418858|"     Recently, there has been increasing interest in performing DBS under general anesthesia,     where the stimulated targets are located anatomically (i.e. on MRI) rather than     physiologically via microelectrode recordings and intra-operative test stimulation. This     technology has been termed asleep DBS and is performed with the patient under general     anesthesia. Intraoperative imaging is utilized to verify the stereotactic accuracy of DBS     electrodes placement at the time of surgery. Because stereotactic accuracy (and surgical     safety) is the surgical endpoint, there is no need for the patient to be awake during the     procedure.   "
66226|NCT02418845|"     The purpose of this clinical trial is to test the safety and efficacy of the oral     investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.   "
66227|NCT02418832|"     Needle aspiration of the epididymis causes rupture and irreversible damage to the duct.     Recurring punctures and needle aspirations of fluid and tissue during Testicular Fine Needle     Aspiration (TEFNA) procedure cause irreparable injury and loss of part of the testis'     tubules. The hypothesis of this research is that production of sperm from the testis will be     improved due to ultrasonically guided Rete Testis needle aspiration. In cases of Obstructive     Azoospermia, the Rete Testis is expected to contain a large number of sperm cells. In cases     of Non-Obstructive Azoospermia, the investigators can expect to produce sperm cells from     aspiration of the Rete Testis, which drains all of the testis' tubules. Furthermore,     catheterization of the Rete Testis will allow for the drainage of all testes tubules and for     the production of sperm cells created locally in some of the tubules or in parts of them.      The potential advantage of needle aspiration from the Rete Testis is that the procedure will     allow for the aspiration from all the testes tubules, as opposed to the standard method of     sperm cells production from the testis which samples only some of the tubules. Therefore, it     is expected that the procedure suggested in this research will be more efficient than the     standard procedures currently in practice. An additional advantage to this procedure is that     puncture and aspiration of the tubule network is not expected to block the drainage from the     testis, as is the case in aspiration of the epididymis, and it is also not expected to damage     the tubules, as is the case in TEFNA and in TESE.   "
66228|NCT02418819|"     This study is designed to investigate the safety, tolerability pharmacokinetics and     pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets     in subjects with schizophrenia.   "
66229|NCT02418806|"     An experimental study designed to test the effectiveness of a psychological intervention     based on group therapy for the caregivers of Alzheimer's disease patients. The intervention     consists of 16 sessions of a cognitive-behavioral psychological group therapy. This study     aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of burden     after been involved in a group therapy.   "
66230|NCT02418793|"     The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the     acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult     subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open     label, dose-escalating study. Each dose cohort will be concluded by a safety review,     following which escalation to the next dose cohort will be approved.   "
66231|NCT02418780|"     The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a     mind-body exercise - on motor and cognitive function as well as quality of life in     individuals recently diagnosed with Parkinson's disease (PD).   "
66232|NCT02418767|"     The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose     levels study in healthy Caucasian and Japanese male volunteers.      Following a 4-week screening period, eligible male subjects will be stratified by ethnic     group and will be randomized to one of six groups. On dosing day, designated as Day 1, each     subject will receive single SC injection of study medication according to group allocation     and will be followed up for a month for safety monitoring.   "
66233|NCT02418754|"     The primary objective of the study is to explore the effect of REGN2176-3 on the Early     Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients     with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept     injection (IAI) monotherapy.   "
66234|NCT02418741|"     The purpose of this study is to investigate whether degree of neck flexion affect on     laryngeal view and discomfort during endotracheal intubation in adult patients.   "
66282|NCT02418104|"     This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess     immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701     compared with two sequential 6 mg SC injections of Neulasta®.   "
66235|NCT02418728|"     In the developing countries, obesity prevalence is on a dramatic rise. Obesity is related to     co-morbidities and as a result, obesity significantly shortens life expectancy and lowers     quality of life. To prevent this, participation in exercise or training programs is     absolutely necessary, in order to generate adipose tissue mass loss. The amount of adipose     tissue mass loss is, amongst others, dependent on lipolysis which is under endocrine     regulation by, mainly, catecholamines, insulin and atrial natriuretic peptide. However, large     variations in adipose tissue mass loss and gain are likely in obese subjects, possibly due to     a decreased lipolytic effect of these hormones (as was shown for catecholamines in the     subcutaneous adipose tissue of obese subjects). However, the relative contribution of atrial     natriuretic peptide in the lipolytic process remains elusive, particularly in subjects with     obesity, which show an increased plasma expression of atrial natriuretic peptide.      The aim of the present study is to observe the contribution of atrial natriuretic peptide in     the subcutaneous adipose tissue of obese subjects. This will be tested by measurements of     extracellular glycerol levels (by microdialysis) in the subcutaneous adipose tissue in situ     at rest and during endurance exercise under local beta- and alpha-blockade.      Eventually, the knowledge gained from this research will contribute to the optimization of     exercise programs for people with obesity.   "
66236|NCT02418715|"     The aim of this study was to investigate the effects of water-based exercises on lipid     profile (LP) and lipoprotein lipase (LPL) levels in premenopausal dyslipidemic women.      It was hypothesized that a water-based aerobic interval-training period would decrease plasma     concentrations of atherogenic lipoproteins and concomitantly increase HDL and LPL levels, as     well as maximal oxygen uptake (VO2max) values.   "
66237|NCT02418702|"     Depression treatment typically is slow acting. Patients presenting with acute suicidality     have few immediate treatment options. However, sub-anesthetic doses of ketamine have been now     widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale showed     this could be applied to suicidal patients, with 14 of 15 participants showing remission of     suicidal thinking within 40 min of the administration of ketamine, with 13 showing lasting     remission out to 10 days. No serious side effects were reported. This project proposes to     conduct a randomized, placebo-controlled trial of this, same intervention in military     patients recently hospitalized for suicidal thinking. After being assessed, and giving     informed consent, participants would receive 0.2mg/kg ketamine or placebo. Their suicidal     thinking, depression, and other symptoms would be monitored acutely for 240 min after drug     infusion, and the for lasting changes the next day, at hospital discharge, 2 weeks, and 10     weeks. Potential adverse events will be monitored via the electronic medical record for up to     a year.   "
66246|NCT02418572|"     Previous work indicates that 2 months androgen pre-treatment may equip preantral follicles     with more FSH receptors and increase the cohort of follicles surviving to the recruitable     antral stage. In this regard it may result in an increase in the oocyte yield and the     reproductive outcome in women with poor ovarian response. These findings provide a strong     rationale for a definitive large RCT. The TTRANSPORT study will include 400 women with poor     ovarian response randomized to receive pre-treatment with transdermal testosterone gel or     placebo in order to provide conclusive evidence regarding the superiority or not of     transdermal testosterone pre-treatment for the management of poor ovarian responders     fulfilling the Bologna criteria.   "
66247|NCT02418559|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     JNJ-63623872 following oral administration of single ascending dose of JNJ-63623872 in     healthy Japanese adult participants.   "
66248|NCT02418546|"     This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an     e-Health application versus in-person nutritional counseling to maintain or increase weight     in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS),     Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the     feasibility, safety, tolerability and efficacy of an e-Health application to maintain or     increase body weight compared to in-person nutritional counseling. Secondary Objectives are     to measure the number of calories required to maintain or increase body weight in     neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the     effects of an e-Health application compared to in-person nutritional counseling on disease     progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using     the PROMIS SF v1.1 scale.   "
66249|NCT02418533|"     This study is for couples pursuing in vitro fertilization (IVF) with preimplantation genetic     screening (PGS) of embryos to achieve pregnancy. The objective of this clinical trial is to     study the effect of mono-menotropins for COS versus recombinant follicle stimulating hormone     (rFSH) on cleavage-stage and blastocyst embryo quality after IVF. Embryo quality parameters     include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse     parameters, and chromosomal aneuploidy rates after PGS.      This pilot study is expected to significantly contribute to optimization of treatment     regimens and stimulation protocols to optimize embryo quality.   "
66250|NCT02418520|"     To elucidate the relationship of chewing miswak sticks on the H. Pylori infection in the oral     cavity.The study would be conducted at the College of Dentistry, KSAU-HS, Riyadh, KSA.      Oral plaque samples would be obtained from those patients who are willing to participate. As     a part of the initial screening the plaque samples would be collected and sent for screening     of oral microbiota to the Microbiology and Biochemistry Department of College of Medicine,     KSAU-HS, NGHA, Riyadh. Here, the basic microbial culturing (rapid urease test) would be     performed for detecting the presence of oral H.Pylori. Volunteers who are tested positive for     H. Pylori infection through the rapid urease test would be invited to participate in the     study.   "
66251|NCT02418507|"     The primary objective for this study is to monitor the change in patient assessed symptoms of     constipation in subjects taking the proprietary probiotic blend compared to those taking the     placebo. The secondary objective for this study is to additionally monitor changes in stool     consistency, stool frequency, quality of life and microbial composition of feces from     baseline to Day 29, in all subjects. Safety considerations monitored any changes in blood     safety parameters as well as incidence of adverse events throughout the entire study for all     subjects.   "
67395|NCT02403583|"     The purpose of the study is to develop and pilot-test a home-based intervention to facilitate     sate HIV testing and disclosure within pregnant couples in order to increase use of     prevention-of-mother-to-child-transmission (PMTCT) and family health services in Kenya.   "
66252|NCT02418494|"     This research trial studies health-related symptom questionnaires in measuring quality of     life in human immunodeficiency virus (HIV)-infected participants treated with or monitored     for anal lesions. Collecting information and symptoms from patients diagnosed with anal     lesions may help reduce the risk of anal cancer.   "
66253|NCT02418481|"     In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination     with tumor reducing surgery, for example cryosurgery going to be investigated.   "
66254|NCT02418468|"     This study compared the efficacy of indacaterol versus placebo in COPD patients classified as     GOLD 2014 Patient Group B.      This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient     Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1     to receive prn salbutamol plus:        1. Indacaterol 150ug or        2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough          FEV1) was assessed after 12 weeks.   "
66255|NCT02418455|"     UX003-CL203 is an open-label, multi-center, Phase 2 study to assess the safety and efficacy     of UX003 in pediatric MPS 7 subjects.   "
66256|NCT02418442|"     Continuation of the CARRA Registry as described in the protocol will support data collection     on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis     for future CARRA studies. In particular, this observational registry will be used to answer     pressing questions about therapeutics used to treat pediatric rheumatic diseases, including     safety questions.   "
66257|NCT02418429|"     Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat     catabolism and resting energy expenditure and decreases plasma insulin and glucose responses     as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP).     Consumption of whey protein has also been shown to increase energy expenditure and favorably     affect gut hormones. Thus, investigators tested consumption of both RS and whey protein on     energy expenditure and gut hormones in lean and obese women and men.   "
66258|NCT02418416|"     Novel approach for Oocyte fertilization failure for difficult cases not respond to     traditional methods of assisted reproduction as intracytoplasmic sperm injection.   "
66259|NCT02418403|"     This is a study of the effect of consumer-directed financial incentives on completion of     advance care planning among Medi-Cal patients.   "
66260|NCT02418390|"     The aim of this study is to investigate the efficacy and safety of prophylactic central lymph     node dissection in papillary thyroid carcinoma.   "
66298|NCT02417896|"     Our aim is to test whether short term perioperative administration of oral spironolactone     could reduce incidence of postoperative acute kidney injury (AKI) in cardiac surgical     patients.   "
66261|NCT02418377|"     Obesity is a complex multifactorial disease where genetics play an important role in     predisposing children to early onset obesity. Though many obesity susceptible genes and     variants have been identified with obesity, the most common obesity gene, MC4R only accounts     for 5% of all early onset obesity cases. This implies that there may be more obesity related     genes and variants that need to be unravelled to further delineate the relationship between     obesity and genetics. The investigators propose in screening the exonic regions of all the     genes in obese subjects using whole-exome sequencing (WES) to discover novel obesity related     variants and genes.      Primary hypothesis The investigators hypothesized that our paediatric subjects with     early-onset severe obesity will have strong genetic predisposition and therefore the cohort     would be enriched with obesity susceptibility genetic variants.      Secondary hypothesis The investigators hypothesized that there is increasing prevalence of,     and possibly worsening, obesity-related complications (namely glucose intolerance,     hypertension, metabolic syndrome, non-alcoholic fatty liver disease) in our severely obese     children, as compared to 15 years ago, due to an increasingly obesogenic environment     promoting unhealthy lifestyle and eating habits.   "
66262|NCT02418364|"     Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the end.     It is often said that the couple suffers from infertility if for a year they could not get a     normal pregnancy. 30% of the reasons for this unsuccess are attributed to women, 30% are     attributed to men, while the other 40% of cases are attributed to the combination between men     and women and for unknown reasons. In women, the source of most of the problems of     infertility are associated with different failures in ovulation (early ovulation, lack of     ovulation or irregular ovulation). Other reasons are Blocked fallopian tubes (due to     endometriosis, infection or surgery), problems in the uterus and endometrium. There is a     group of women that apparently does not have the failures described above, and they have     infertility that does not include pathological findings. Apparently chronic stress is a     potential cause among couples who could not get pregnant (despite 6 months of focused sex) so     there is a request for various techniques for reducing stress including yoga and meditation.     One common option in various conditions of infertility is in vitro fertilization. This     technique is also known as artificial insemination and is the most common technique used in     Israel. Data from the Ministry of Health from the last years, indicate that the rate of     successful pregnancies after embryo transfer is more than a third (in average), this is from     an average of 20 treatment cycles.      Researches in alternative medicine are not easy to carry out. The placebo group which is     usually the control group tend to be a treatment group by itself and gives effective results     than a group that does not receive treatment at all. Carrying out a strict study with a good     control group such as reflexology research in multiple sclerosis, has brought significant     results in various statistical measures examined in this study (movement, sensory mode and     urinary tract symptoms).      In the control group the calf was chosen as a place of a massage as a dummy treatment     (gynecological place), which prevented contact with specific points of the feet like in     patients in the treatment group. This study wishes to answer the research question: Does     reflexology treatment increase the chances of pregnancy implantation in women without     pathological findings that are treated with IVF. Other questions related to measures that     could lead to the implant of pregnancy, are whether reflexology treatment affect the     endometrial thickness, number of oocytes and embryo quality. Literature indicates the     potential of reflexology treatment on ovulation induction (But requires a good control group     and large sample size).   "
66263|NCT02418351|"     STUDY OBJECTIVES:      Primary Objective: Assessment of treatment safety based on incidence of any treatment     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months     post treatment.      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and     gadolinium-enhanced magnetic resonance imaging (MRI).   "
66264|NCT02418338|"     Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain     evaluation in Duchenne muscular dystrophy children versus a control group.   "
66316|NCT02417662|"     The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard     chemotherapy in patients with oligometastatic non-small cell lung cancer. Patients will be     randomised to receive either standard treatment alone (platinum-based doublet chemotherapy)     or standard treatment with conventional radiotherapy (RT) and SABR.   "
66265|NCT02418325|"     STUDY OBJECTIVES:      Primary Objective: Assessment of treatment safety based on incidence of any treatment     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months     post treatment.      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and     gadolinium-enhanced magnetic resonance imaging (MRI)   "
66266|NCT02418312|"     Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains     unclear.   "
66267|NCT02418299|"     The purpose of this study was to evaluate the effect of a non-invasive Er:YAG thermal laser     therapy in treating female stress and mixed urinary incontinence.   "
66268|NCT02418286|"     The Purpose of this trial is to define the characteristics of the patients with low back pain     in oriental rehabilitation clinic. This information will create a registry that will help us     to compare similarities and differences in patients and their symptoms. The more patients the     investigators are able to enter into the registry, the more the investigators will be able to     understand the low back pain and learn better ways of caring for patients.   "
66269|NCT02418273|"     The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in     children treated with glucocorticoids for rheumatic disorders. This is a pilot Phase 1/2,     randomized open-label, 12-month clinical trial of denosumab to assess its effect on bone     resorption markers and bone mineral density (BMD) in children with rheumatic disorders, age 4     to 16 years, recruited within 1 month of starting a chronic systemic glucocorticoid regimen.     Primary outcomes include suppression of bone turnover markers and safety assessments.     Secondary outcomes include changes in bone density as measured by dual energy X-ray     absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) densitometry at     the radius and tibia.   "
66270|NCT02418260|"     This study intends to determine the best surgical treatment for humeral shaft fractures. One     third of the patients will be treated with open reduction and internal fixation with plate;     one third, with bridge plate technique and the remaining third with locked intramedullary     nail.   "
66271|NCT02418247|"     The researchers investigated the rate of biochemical remission in patients without     radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in     differentiated thyroid cancer patients who underwent total thyroidectomy.   "
66272|NCT02418234|"     The purpose of this study is to compare the frequency and abundance of T790M mutation among     the different Clinical modes of EGFR-TKI failure.   "
66273|NCT02418221|"     This study aims to define a provocation test for histamine intolerance (aka. biogenic amine     intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate     this condition.   "
66274|NCT02418208|"     Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked     response potentials in adolescents, young adults and Adults.      Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to     1500 subjects will be enrolled in 4 or more sites. Study duration: Each patient will be     followed up for up to 1 year. Overall study duration will be up to 1.5 years. Patient     population: Adolescents, young adults and Adults of both genders.      Age range:        -  10-11.99        -  12-13.99        -  14-15.99        -  16-17.99        -  18-24.99        -  25-29.99        -  30-34.99        -  35-39.99        -  40-44.99        -  45-49.99        -  50-54.99        -  55-60        -  60 and above      Objective: Establishment of normative data of BNA.   "
66275|NCT02418195|"     The purpose of this study is to examine whether neural-derived exosomal miRNAs are     differentially expressed that are specific to suicidal ideation or behavior, and which by     affecting specific miRNA targets and pathways, are associated with suicidal behavior and     response to ketamine. The following groups of subjects will be examined: 1) major depressive     disorder (MDD) with a recent suicide attempt (in past 2 weeks), 2) MDD with serious ideation     (in the past 7 days) without recent suicide attempt (in the past 6 months), 3) MDD without     clinically significant suicidal ideation (in the past 7 days) or recent suicide attempt (in     the past 6 months), and 4) healthy controls. Both suicidal and non-suicidal MDD will be given     ketamine (0.5 mg/kg, IV) and blood will be drawn at predose, 30 min, 180 min, 24 hours, and     14 days post-infusion to measure changes in miRNAs.   "
66276|NCT02418182|"     Current standard of care is no pretreatment medications before the egg retrieval, and the     investigators would like to evaluate if preoperative Tylenol improves procedure and post     procedure pain control over the current practice (no pre-treatment). Specifically, this study     will compare Tylenol with a placebo when given before retrieval procedures. The investigators     believe that if Tylenol can offer better analgesic relief than no pretreatment medications,     then it may reduce the amount of narcotics needed by patients during and after the procedure     and contribute to better patient satisfaction. . This study will enroll 100 participants all     from UAB.   "
66277|NCT02418169|"     This study evaluates the association between traumatic brain injuries and craniofacial or/and     skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary     diagnostics of trauma patients.   "
66278|NCT02418156|"     Objective is to actively gather information on the use of CorMatrix ECM for vascular repair     in the reconstruction of the femoral artery.   "
66279|NCT02418143|"     Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a     post market observational study.   "
66280|NCT02418130|"     A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy     and safety of 'Ursa Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.   "
66281|NCT02418117|"     The investigators' aim is to evaluate the accuracy of the stereolitographic template     comparing the final implant insertion to the planned implant position at coronal and apical     level.      Clinical relevance:        -  To identify factors influencing the surgical template imprecision.        -  To overcome risk factors for surgical template imprecision.        -  To suggest improvements for highly accuracy of the surgical template especially for          immediate loading and avoiding the injury of anatomical structures.   "
68596|NCT02388087|"     The purpose of the study is to investigate the efficacy of the ROX coupler in treating     patients with tilt test proven Neurally mediated syncope.   "
66283|NCT02418091|"     This study will build a population management system Simultaneous risk factor control using     Telehealth to slOw Progression of Diabetic Kidney Disease STOP-DKD Application STOP-DKD APP     and conduct a 6-month controlled trial to compare reduction of blood pressure. In addition,     the study will evaluate the feasibility of future large-scale intervention to slow diabetic     kidney disease (DKD) DKD progression.      Aim 1: Identify patients with moderate DKD and uncontrolled hypertension (HTN) using existing     electronic health record data in an integrated data warehouse (Southeastern Diabetes     Initiative- SEDI) to screen all patients within SEDI.      Aim 2: Implement an intervention designed to slow progression of DKD and treat associated     conditions in a high-risk population with moderate DKD and uncontrolled HTN using the     STOP-DKD APP        -  Primary Outcome: Test the hypothesis that patients who receive the intervention will          have greater improvements in blood pressure as compared to a control group after 6          months        -  Secondary Outcomes: Exploratory analyses to determine whether patients who receive the          intervention will have less progression (defined as a smaller decrease in kidney          function), and improved behaviors that affect HTN control and cardiovascular risk          (medication adherence, diet, physical activity, and weight control) as compared to a          control group after 6 months      Aim 3: Evaluate the STOP-DKD APP Study to guide large-scale implementation & dissemination        -  Impact Evaluation: Assess the potential population impact of our intervention using the          Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework        -  Economic Evaluation: Conduct an economic evaluation using the Archimedes Model by          estimating projected costs and quality-adjusted life-years   "
66284|NCT02418078|"     The aim of this study is to compare the geriatric patients with the non-geriatrics undergoing     outpatient unilateral herniorrhapy in terms of local anesthesia, sedation, recovery and early     morbidity.   "
66285|NCT02418065|"     The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach     including exercise training program with ergocycle during dialysis sessions, oral nutritional     supplementation, omega 3 and androgen, on effort tolerance and quality of life of     under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.   "
66299|NCT02417883|"     In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the     glomerulus was considered to have the main importance. Kidney's tubular atrophy and     interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate     the function of the kidney's tubule-interstitium through furosemide excretion after     intravenous administration of this drug, and correlate the rate of excretion of furosemide     with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic     kidney disease.   "
66286|NCT02418052|"     Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer     deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective     management for resectable EC. Gastric tube is considered to be an ideal substitute for the     resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract     reconstruction in MIE. However, the tension at the anastomosed area can not be ignored and     may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a     standard post-operative posture after tracheal resection and reconstruction, and aimed to     relieve the anastomotic tension. In this study, the investigators attempt to adopt the     maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing     the incidence of CAL.   "
66287|NCT02418039|"     A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will     be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal     protein diet ( n = 40 ) during one month. Randomization will be conducted by an external     monitor and will keep the secret codes until the end of the study. All patients will be     provided with structured menus and two snacks a day as an amaranth protein supplement. The     supplement will content the same amount of fiber but the protein content will vary depending     on the group to which the patient is assigned.   "
66288|NCT02418026|"     Cesarean section rates continue to increase worldwide, particularly in middle- and     high-income countries. In France, the rate has now stabilized around 20 %. Cesarean section     is a particular way of giving birth, sometimes desired, but sometimes feared. If some women     do not feel affected by this way of giving birth, it is more difficult for others to live     with. In this way, not being able to give birth trough natural way may be disturbing in     motherhood. At La Rochelle hospital, more than 230 healthcare providers have been trained     according to Erickson's hypnosis methodology. Among them, 40 are part of the anesthesia     department and a committee oversees the hypnotherapist activities in pain management. The     objective of the present study is to assess the benefit of hypnosis session for improving     experience and reducing anxiety in women giving birth through surgery.   "
66289|NCT02418013|"     This study aims to carry out a safety evaluation of human cord blood and frozen plasma as     treatment for pre-frailty , to assess whether the treatment can prevent and improve the aging     process, and to identify useful clinical markers of frailty.      The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial     conducted at CHA clinical trial institute.   "
66291|NCT02417987|"     The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to     compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in     combination with eccentric training to placebo treatment (sham treatment combined with     eccentric exercises).      Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5%     bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (~ 4     mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training     program and examinations will be done at baseline (before treatment) with follow-ups after 6     weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and     differences between groups (HVI, ACP and Plc)   "
66292|NCT02417974|"     The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the     risk of endoscopic recurrence of CD in patients after intestinal resection. The specific     outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety     and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will     prevent establishment of pro-inflammatory microbiome after surgery, leading to a reduced     probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will     be safe and well-tolerated in these patients.   "
66293|NCT02417961|"     The purpose of the study is to assess functionality, performance, and reliability of an     accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in     an at-home setting reported by the patient or caregiver, and to confirm the safety and     clinical benefit of benralizumab administration in asthma patients with severe asthma.   "
66294|NCT02417948|"     This randomized clinical trial uses an educational brochure and online tutorial program to     assess sun-protective behavior and skin self-examination among African Americans. Skin cancer     is very common among African Americans, with a disproportionately high mortality rate.     Providing a brochure and an online educational program about sun-protective behaviors may     encourage African Americans to take preventative measures against skin cancer, help improve     early skin cancer detection, determine how far the disease has spread, and plan the best     treatment.   "
66295|NCT02417935|"     The main purpose of this study is to evaluate the effectiveness and safety of the study drug     known as duloxetine in participants with diabetic peripheral neuropathic pain.   "
66296|NCT02417922|"     The purpose is to see if Autologous Conditioned Plasma (ACP) promote and accelerating tendon     tissue healing in Conservative treated total Achilles Tendon Tears.      40 healthy males were randomized to either receive ACP or Placebo (saline) around the     ruptured achilles tendon at baseline, 2 weeks, 4 weeks and again after 6 weeks during the 8     weeks immobilization period with an orthosis. Ultrasound and symptoms scores (ATLS) was     performed at baseline, after 8 weeks immobilization and again after 3 month, 6 month and 12     month. Scoring and functional tests was performed after the 8 weeks immobilization and again     after 12 weeks, 24 weeks and 52 weeks from injury date.   "
66301|NCT02417857|"     The aim of this study is to compare outcomes of quality-of-life measures and evaluate the     body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and     Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30     underwent LC.Fifty-eight patients were included the study and divided into two groups. The     results of the questionnaires were statistically compared.   "
66302|NCT02417844|"     Two tamsulosin HClformulations will be tested in fed state   "
66303|NCT02417831|"     A bio-equivalence of 2 different capsule formulations in fasted subjects   "
66304|NCT02417818|"     In plastic and reconstructive surgery, treatment strategies of second-degree burns,     superficial wounds, burn scars, flaps and chronic wounds aim at reducing infection and     improving microcirculation. Although previous studies indicate that Plasma Therapy can     accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of     action. Therefore, the aim of this study is to evaluate the microcirculatory effects of     Plasma Therapy on second-degree burns, superficial wounds, burn scars, flaps and chronic     wounds in a human in-vivo setting for the first time.   "
66305|NCT02417805|"     In plastic and reconstructive surgery, treatment strategies of second-degree burns,     superficial wounds and chronic wounds aim at reducing infection and improving     microcirculation. Although previous studies indicate that remote ischemic preconditioning     (RIPC) can accelerate wound healing, only a few studies focused on the elucidation of its     mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory     effects of remote ischemic preconditioning on second-degree burns, superficial and chronic     wounds in a human in-vivo setting for the first time.   "
66306|NCT02417792|"     At least 20 psoriasis patients will be compared to at least 20 participants without psoriasis     Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal     bacterial populations will be compared in order to examine whether there are differences     between the groups.   "
66307|NCT02417779|"     In plastic and reconstructive surgery, treatment strategies of second-degree burns,     superficial wounds, hypertrophic burn scars, flaps and chronic wounds aim at reducing     infection and improving microcirculation. Although previous studies indicate that     extracorporeal shock wave therapy (ESWT) can accelerate wound healing, only a few studies     focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is     to evaluate the microcirculatory effects of extracorporeal shock wave therapy on     second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds in     a human in-vivo setting for the first time.   "
66308|NCT02417766|"     Background:      - There are many types of immune disorders. These range from rare immune deficiencies to     allergies to autoimmune disease like rheumatoid arthritis. Genes are the instructions our     body uses to work and develop. A new technology called whole exome sequencing may help find     the cause of these disorders. Whole exome sequencing is a way to look at many genes at once     for errors. Researchers hope to find new gene changes that lead to immune disorders.     Additionally, researchers are interested in finding the best way to manage unexpected but     important findings by whole exome sequencing.      Objectives:      - To better understand genetic causes of immune system disorders. Also, to better understand     people s thoughts and feelings about immune system disorders and new genomic testing.      Eligibility:      - People ages 0 100 with an immune disorder or a relative with an immune disorder. People     must be at least 2 to be evaluated at the NIH clinical center. People must be at least 12 to     do the survey/interview portion of the study.      Design:        -  Participants will have their genes sequenced. They may be asked for a new sample of          blood.        -  If participants cannot come for a study visit, they can have a blood sample collected by          their local lab or doctor and sent by mail.        -  Researchers may or may not find the cause of the participant s immune disorder.          Participants will learn that information. Some participants may be asked to return to          NIH to get results and have more tests.        -  Researchers may share information with other studies. The data will be anonymous.        -  For the survey part of the study, participants will answer questions about their or          their relative s immune disorder. They will also answer about their thoughts and          feelings about genomic testing.        -  Some participants will be asked for a brief interview to ask more about the survey          topics. There may be more follow-up after several months.   "
66317|NCT02417649|"     Chronic obstructive pulmonary disease (COPD) are characterized by frequent relapses, often     resulting from common bacterial infections. Enhancing the immune response in these patients     may decrease the frequency of these relapses. The use of a mechanic Polyvalent Bacterial     Lysate (PMBL, Ismigen, 13 bacterial strains)may enhance the immune response and therefore     help significantly to the control of relapse in these patients.      In the current study the effect of the administration of the PBML to patients older than 40     years, with moderate, severe or very severe COPD, in good or discrete physical condition on     the number of relapses in an observation period of 12 months. In addition, the effect of the     PMBL on the duration of the interval between relapses, on relapse symptoms, on the use of     other drugs, on the number of days of absence of work, on the number of hospitalizations and     duration thereof and on potential toxicity of the treatment.   "
66318|NCT02417636|"     PUBLIC HEALTH EVALUATION PROTOCOL on Impact of Task Shifting Type II for ART Delivery on     Patient and Process Outcomes in Uganda   "
68597|NCT02388074|"     This is a single center study to assess the efficacy of CyPath® Early Detection Lung Cancer     Assay to detect lung cancer cells from deep lung sputum.   "
66309|NCT02417753|"     Background:      - Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid     built up in the abdomen. Researchers want to see if a new drug can affect some of the immune     cells in the ascites. This may also treat the cancer.      Objective:      - To look at the immune markers the ascites of people with gastrointestinal or ovarian     cancer.      Eligibility:      - Adults age 18 and older with a malignancy of the gastrointestinal tract (GI) tract or     metastatic ovarian cancer. As a result, they have ascites in the abdomen.      Design:        -  Participants will be screened with:        -  Medical history, physical exam, and blood tests.        -  Echocardiogram: sound waves make images of the heart.        -  Electrocardiogram: measures electrical activity of the heart.        -  Paracentesis: a needle will be inserted in the abdomen and will remove some of the          ascites fluid.        -  They may have a tumor biopsy.        -  Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in          cycle 1 and 4 times all other cycles. Each cycle is 28 days.        -  Each cycle, participants will:        -  Have a physical exam.        -  Have blood tests weekly.        -  Be asked about how they feel and any medicines they are taking.        -  After every 2 cycles (about every 2 months), participants will have scans and x-rays of          their tumor.        -  Participants will have paracentesis 2 more times during the study. They will have          another echocardiogram.        -  At the end of therapy, participants will have a physical exam and blood tests. They will          be asked about how they feel and any medicines they are taking.   "
66310|NCT02417740|"     Background:      - Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure     in the blood vessels of the liver. It seems to start slowly and not have many warning signs.     Many people may not even know that they have a liver disease. There are no specific     treatments for NCPH.      Objectives:      - To learn more about how NCPH develops over time.      Eligibility:      - People age 12 and older who have NCPH or are at risk for getting it. In the past year, they     cannot have had other types of liver disease that typically result in cirrhosis, liver     cancer, or active substance abuse.      Design:        -  Participants will have 2 screening visits.        -  Visit 1: to see if they have or may develop NCPH.        -  Medical history        -  Physical exam        -  Urine and stool studies        -  Abdominal ultrasound        -  Fibroscan. Sound waves measure liver stiffness.      <TAB>- Visit 2:        -  Blood tests        -  Abdominal MRI        -  Echocardiogram        -  Questionnaire        -  Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is          done with a small tube inserted in a neck vein.        -  They may have a liver biopsy.        -  All participants will visit the clinic every 6 months for a history, physical exam, and          blood tests. They will also repeat some of the screening tests yearly.        -  Participants with NCPH will also have:        -  Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and          stomach.        -  At least every 2 years: Esophagogastroduodenoscopy.        -  At least every 4 years: testing including HVPG measurements and liver biopsy.        -  Participants without NCPH will also have:        -  Liver biopsy and HVPG measurements to see if they have NCPH.        -  Every 2 years: abdominal MRI and stool studies.        -  The study will last indefinitely.   "
66397|NCT02416609|"     Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of     a chemotherapy regimen with Gemcitabine and Oxaliplatin administered sequentially with     stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined     treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).   "
66311|NCT02417727|"     Background:      - Some people with movement disorders are in another NIH protocol. They will have electrodes     placed in deep brain areas. They may do tasks before, during, and after surgery. Researchers     want to learn more about how brain cells and networks work while people learn and remember.     They want to use the data from the other NIH study to do this.      Objective:      - To share data from before and during deep brain stimulation surgery. The data will be used     in a study of how the brain learns and remembers.      Eligibility:      - People at least 18 years old who are in protocol 11-N-0211 and have certain movement     disorders.      Design:        -  As part of protocol 11-N-0211, data on participants brainwave activity is collected. In          this protocol, they will have that data stored and shared.        -  Researchers will access imaging data from deep brain stimulation surgery.        -  Researchers will access other medical records.   "
66312|NCT02417714|"     Background:      - Computed Tomography (CT) is a scan that makes detailed pictures of the body. It uses     radiation to do that. In 2011, about 85.3 million CT scans were done in the United States.     But there is growing concern about the health effects of radiation. There are new and     different ways to make CT pictures that use less radiation. Researchers want to learn whether     these new methods create images that are similar to images from a traditional CT.      Objective:      - To learn if new CT imaging methods with less radiation make images that are similar to     traditional ways.      Eligibility:      - Adults 18 years of age and older who are scheduled for a CT of the chest, abdomen and     pelvis with contrast.      Design:        -  Researchers will review participants medical records to see if they can be in this          study.        -  Participants may have blood drawn from an arm vein by a needle stick. The blood will be          used to make sure they can be in this study and that it is safe for them to have          contrast.        -  During the participants CT scan appointment, one extra scan will be done using low          radiation methods.        -  During a CT scan, the participant lies on a table. A large x-ray machine takes pictures          of the body.   "
66313|NCT02417701|"     This phase II trial studies how well target of rapamycin complex 1/2 (TORC1/2) inhibitor     MLN0128 works in treating patients with lung cancer that is stage IV or has come back     (recurrent) and has a mutation in the nuclear factor, erythroid 2-like 2 (NFE2L2) or     kelch-like ECH-associated protein 1 (KEAP1) gene. Damage to these genes may cause the cancer     to grow. TORC1/2 inhibitor MLN0128 may stop this from happening by blocking enzymes.   "
66314|NCT02417688|"     To demonstrate feasibility of imaging Cu[64]-25%-CANF-Comb uptake in the atherosclerosis of     the carotid artery of patients for whom carotid artery endarterectomy surgery is planned in     comparison to the carotid artery for which intervention is not planned.   "
66315|NCT02417675|"     The Western Cape province of South Africa (SA) is changing the way it treats pregnant women     with HIV. Now, all HIV-infected pregnant women, regardless of how sick or healthy they are,     will receive antiretroviral treatment (ART) for life (Option B+). However, there are few     well-developed models of service delivery to support this change to Option B+ in the     Western Cape and many parts of the continent.      The parent study -- Strategies to Optimize ART Services for Maternal & Child Health     (MCH-ART)-- is testing two clinic-based models of service delivery for Option B+ . To     complement MCH-ART, this study, PACER, will test whether community-based Adherence Clubs are     an effective model for keeping breastfeeding women in HIV care after pregnancy. These clubs     have been used to free up space at ART clinics by moving stable HIV+ patients to     community-based services, but they have not been studied as an effective strategy among     breastfeeding women after delivery. PACER seeks to address this gap.   "
66319|NCT02417623|"     AIM: To assess the efficacy of an intervention that includes the assistance of a weight loss     smartphone application targeted to young people aged 18 to 40 years.      DESIGN: Randomisedclinical trial.      SETTING: Primary Health Care centres (PHCCs) in Catalonia.      PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting     PHCCs for any reason and who provide written informed consent to participate in the trial.      INTERVENTION GROUP will receive a 12-month weight loss programme that implements     recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed     specifically for this programme.      CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12     months.      EXPECTED RESULTS: The investigators expect a higher weight loss in the intervention group     than in control group.   "
66320|NCT02417610|"     The purpose of the study is to assess the validity of the polynucleotide within the intra     articular treatment of osteoarthritis of the knee, comparing it with that of hyaluronic acid,     the most commonly used.   "
66321|NCT02417597|"     This phase IV clinical study was designed to evaluate the safety and immunogenicity of the     recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,     in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will     receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month     schedule.   "
66323|NCT02417571|"     Control of blood pressure (BP) is the first thing to do in the management of chronic kidney     disease (CKD). Although guidelines suggest the optimal blood pressure level, it is hard to     assess BP correctly during the office visit. Often there is a discrepancy between office BP     and out-of-office BP, including home BP and ambulatory BP. Recent study reported that as many     as 34% of Korean CKD patients had masked hypertension, which means high BP by ambulatory BP     monitoring but normal BP by conventional office BP measurement.      This study aims to evaluate the effect of ambulatory BP-guided BP management on the clinical     outcome of CKD, compared to the conventional management using office BP.   "
66324|NCT02417558|"     The study involves a novel Virtual Reality Interface that offers full-body immersion     Alterniity AR and more specifically computer exercises blended with game activities. It was     hypothesized that Alterniity AR facilitated, game blended cognitive and/or physical     exercise improves global cognition when compared to control groups; moreover, these     improvements may be manifested by brain activity changes. The investigators explore here the     impact of potential moderators on combined exercise-induced cognitive benefits, as well as,     individual/separate training schemes.      In addition, the proposed study will provide Alterniity AR in a closed feedback loop with a     direct, reliable, and non-invasive method for assessing changes in brain activity associated     with elderly in risk of dementia. The paradigm for the current study will combine     neurophysiological knowledge with mathematical signal processing and pattern recognition     methods to temporally and spatially map brain function, connectivity and synchronization.   "
66325|NCT02417545|"     The aim of this study is to assess the differences in gaze and gait during the stair and ramp     negotiation (+transition to normal level walking) between healthy controls and vestibular     patients (fallers and non-fallers).   "
66326|NCT02417532|"     Prospective, Open label, single arm, non-randomized, non-comparative registry study of     Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients     with Spinal cord or other injury preventing unsupported patient ambulation.   "
66327|NCT02417519|"     Chlorogenic acid (CGA) in coffee may lower the postprandial glucose response. CGA is     destroyed by dark roasting. In a controlled crossover trial, 11 healthy fasted volunteers     consumed 300 mL of either light (LIR) or dark (DAR) roasted coffee, or water, followed 30 min     later by a 75-g oral glucose tolerance test (OGTT). Plasma glukose and insulin, appetite, and     plasma and urine metabolic profiles will be analysed. The primary aim is to investigate     whether roasting affects the postprandial glucose area under the curve (AUC).   "
66328|NCT02417506|"     The repetitive motions associated with active life and many sports can increase the wear and     tear to the joints that leads to decrease in flexibility and joint pain finally heading its     way to osteoarthritis. Activities such as jumping, running can wear away the cartilage that     supports and cushions the joints of hands and knees, causing bones to rub against each other.     Injuries stemming from repetitive motions can also cause and worsen the joint pain.      Joint pain is discomfort that arises from any joint . Irrespective of the underlying     mechanisms, joint pain usually originates in activation of nociceptors, or free nerve     endings. Complex neuronal activation occurs, which involves not only local sensitization of     joint nociceptors but also modifications in central pain pathways.      Even though, the numerous pharmacological interventions are available for joint pain, there     is much debate amongst clinicians about the best approach to the treatment of joint pain.     NSAIDs which is frequently used for treatment in such cases, carries concerns related to     gastro-intestinal system, cardiovascular system as well as central nervous system .      Hence there is a need of a safer alternative treatment option for relieving acute joint pain     which is comparable to the modern medicines, without posing concerns to the subject's general     well being.      Herbs are known to be used since ages in traditional literature and do not pose any potential     health concern. Inspite of such positive attributes herbs are not employed in treatment of     acute pains as there is lack of evidence proving the same.      In order to address the need of the hour Enovate Biolife has invented a novel poly herbal     formulation E-OA-07 (Lanconone). Lanconone has been studied previously in patients with     osteoarthritis has been proven efficacious . It has a good history of marketing and is sold     in the United States, with no reported adverse event related to the product. However there is     no concrete evidence proving the product's acute pain relieving dynamics, hence the current     study has been employed to comprehend the effect of lanconone in joint acute pain.   "
66329|NCT02417493|"     The purpose of the present study is to determine if asking adolescent patients (ages 13-17)     to self-inject an empty syringe into their thigh during routine clinic visits results in     increased reported comfort with self-injection, reduced anxiety regarding self-injection and     food allergy management for both patient and caregiver(s), and in greater perceived     likelihood of epinephrine self-injection, in the event of an emergency.   "
66330|NCT02417480|"     This study will pilot test the use of two mHealth devices. One is called the Bite Counter and     one is called a MisFit. The study will be among a sample of participants (n = 50) to monitor     their eating and sleeping habits. The Bite Counter is a wearable watch-like device that     detects and records when an individual has taken a bite of food. The benefit of using the     Bite Counter is that it places a low-burden on participants to self-monitor their dietary     intake. The MisFit is a commercial device that tracks an individual's sleeping and activity.      The purpose of this study is to (1) find out how the Bite Counter calculates daily bites     taken on a vegan diet compared to an omnivorous diet, (2) examine differences in sleep and     activity between individuals following a vegan diet compared to an omnivorous diet and (3)     get feedback from users before the device is tested in larger studies.   "
66342|NCT02417324|"     The I-HIT-MED registry registers clinical of children and adults with medulloblastoma,     ependymoma, pineoblastoma, or CNS-primitive neuroectodermal tumour (CNS-PNET) in Germany and     other countries that fulfil national ethic requirements for participation in this registry.     These tumours are rare diseases, and many patients are treated outside of clinical trials.     The I-HIT-MED registry allows collection of data und biological material from those patients,     and provides a basis for standard treatment recommendations and counselling. It aims to     improve the international cooperation and the medical knowledge in these rare diseases.     Within the I-HIT-MED registry, it is a goal to maintain and improve networks for quality     assurance in national groups where they are already established, and to support the     implementation in national groups, where there is no quality assurance network yet.   "
66352|NCT02417194|"     The effect of preoperative glycemic control measured by HbA1c on renal cell carcinoma (RCC)     outcome remains controversial. Thus, the investigators aim to examine the association of     preoperative glycemic control with oncologic outcomes after radical or partial nephrectomy.     The investigators will prospectively collect the relevant data including preoperative HbA1c     in 238 patients of RCC patients undergoing nephrectomy. The associations between clinical     variables and risk of adverse pathological features and disease recurrence will be tested     using a multivariate logistic regression and multiple Cox-proportional hazards model,     respectively.   "
66331|NCT02417467|"     Smoking-related diseases contribute to the death of more than 37,000 Canadians annually. Of     that number, almost one-third die of cardiovascular-related causes. Smoking cessation can     decrease the additional risk of heart disease by 50% after 1 year. However, even using     smoking cessation therapies, only 10-20% of smokers will be able to successfully quit smoking     long-term. Therefore, new and alternative treatments are needed.      The e-cigarette is a battery-powered device approximately the size and shape of a cigarette     that creates a smoke-free vapour which is inhaled by the user. Since it feels like smoking a     cigarette, using the e-cigarette may help some smokers quit. Some e-cigarettes also contain     nicotine, which can reduce withdrawal symptoms from quitting smoking. However, e-cigarettes     have not been approved for use for smoking cessation by Health Canada or the FDA. Despite     this, these devices are rising in popularity. A recent US Centers for Disease Control survey     found that of smokers who were motivated to quit within the next 6 months, 48.5% had tried     e-cigarettes.      The Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial will be the     first large trial to address the important issue of e-cigarettes for smoking cessation in     Canada. The trial will randomly assign participants to receive nicotine e-cigarettes and     minimal counseling, non-nicotine e-cigarettes and minimal counseling, or only minimal     counseling for 12 weeks. Participants will then be followed for one year to see which (if     any) group is more likely to have quit or reduced their smoking. Information about potential     side effects and safety will also be collected. The E3 Trial will provide law-makers and the     public with important information about the use of e-cigarettes for smoking cessation.   "
66332|NCT02417454|"     The purpose of this study is to investigate the effects of a probiotic blend on qualitative     (subjective interviews and self-reporting) and quantitative (changes in brain activity, heart     rate, cortisol, and reactivity) measures of stress in healthy undergraduate students.   "
66333|NCT02417441|"     The purpose of the trial is to record the use of the medical device EEVA™ (Early Embryo     Viability Assessment) by comparing the rate of implantation of transferred embryos selected     using the scores from the device EEVA™ plus morphology grading versus transferred embryos     selected using the morphology grading only.   "
66334|NCT02417428|"     The main objective of this study is to determine if oral supplementation of Citrulline, when     combined with HIIT, can produce significant changes in body composition, muscle quality,     muscle metabolism and functional capacity in older obese men and women .      The investigators hypothesize that Citrulline combined with HIIT will be more beneficial than     HIIT alone which will be more beneficial than citrulline alone which will be more beneficial     than placebo alone in obese elderly men and women .   "
66335|NCT02417415|"     Patients with autonomic failure are characterized by disabling orthostatic hypotension (low     blood pressure on standing), and at least half of them also have high blood pressure while     lying down (supine hypertension). Exposure to heat, such as in hot environments, often     worsens their orthostatic hypotension. The causes of this are not fully understood. The     purpose of this study is to evaluate whether applying local heat over the abdomen of patients     with autonomic failure and supine hypertension would decrease their high blood pressure while     lying down. This will help us better understand the mechanisms underlying this phenomenon,     and may be of use in the treatment of supine hypertension.   "
66336|NCT02417402|"     The aim of this trial is to investigate if patients treated by physical therapists who     received an update on clinical practice guidelines and pain management have better outcomes     than patients treated by physical therapists who did not received such training.   "
66337|NCT02417389|"     To assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus     alendronate in controlling bone loss induced by primary hyperparathyroidism.   "
66338|NCT02417376|"     The purpose of this study is to determine whether scaling and root planing as a periodontal     intervention helps in improving the overall health of patients suffering from coronary heart     disease.   "
66339|NCT02417363|"     Analysis of inflammatory markers in periodontitis and patients with early and middle stage     renal disease.   "
66347|NCT02417259|"     We are conducting a prospective cohort study of 20 children with cyanotic congenital heart     disease who are admitted for cardiac surgery. We will record cerebral and somatic near     infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien     INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively     (baseline) and continue until 48hours post-operatively. We will also take measurements prior     to discharge from hospital. Baseline demographics, physiological and laboratory variables     will be recorded. Clinical outcome variables including mortality, duration of intensive care     unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance     will also be recorded.   "
66524|NCT02414958|"     Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin     regimen of MDI or CSII. Randomisation to 3 treatments arms (equal assignment) following a     screening period, an optimisation period and a run-in period. 52 week double-blind treatment     period, and 3 week follow-up period.   "
66340|NCT02417350|"     The investigators planned study is a randomized, controlled exploratory study of a ketogenic     and a NFA (National Food Administration) recommended diet. Study participants will be female     nutrition students with both knowledge and interest in dietary surveys, in order to increase     motivation and adherence. They will be provided with cooked food. The women should be weight     stable and maintain their physical activity during the study, in order to evaluate how the     diet itself affects various health parameters. The investigators intend to investigate diet     specific biomarkers (small molecules involved in metabolism) in the blood, as well as blood     lipids, body composition, gut microbiota, energy substrate utilization, exercise performance,     resting metabolic rate, hormones, cognition and sweet cravings. In addition, the     investigators intend to qualitatively study the experience of following both of these dietary     regimes. The investigators intend to make a short and controlled study. The study is expected     to reveal whether the ketogenic diet is a healthy or unhealthy diet in the short term. The     investigators also expect that data from this study will be a helpful tool to measure diet     adherence in future long-term studies.   "
66341|NCT02417337|"     Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics     are needed to diminish the pain [1]. Development of pain after completion of root canal     treatment may undermine patients' confidence in the procedure and the clinician [2].     Non-steroidal anti-inflammatory drugs are one of the most frequently taken analgesic     medications for dental pain. Their popularity attributed to their efficacy in relieving pain     and fever and low side effect profile at therapeutic doses [3]. Mono-therapy analgesic has a     low effect on dental pain. Improvement was performance by combining analgesics with different     mechanisms of action without raising any adverse effects [4], was effective in controlling     moderate to severe pain. The combination of a non-steroidal anti-inflammatory drug (NSAID)     and paracetamol has shown additive analgesia for treating dental pain in several studies     [5,6]. Endodontic treatment with a lower prevalence of postoperative pain is usually the     treatment of choice. There have been no controlled dental studies evaluating the additive     effects of combining a non-steroidal anti-inflammatory drug with paracetamol. Breivik et al     [6] & Menhinick et al [7] found that a combination of acetaminophen and ibuprofen was more     effective than ibuprofen alone in managing postoperative pain. Aim of the present study, to     evaluate the efficacy of the paracetamol when used alone and in combinations with three     groups of drugs to control postoperative endodontic pain.   "
66343|NCT02417311|"     Heart failure (HF) is the common end-stage of different medical conditions. It is the only     growing cardiovascular disease and its prognosis remains worse than that of many     malignancies. The lack of evidence-based treatment for patients with diastolic HF (HFpEF)     exemplifies that the current one for all therapy has to be advanced by an individualized     approach. Inherited cardiomyopathies can serve as paradigmatic examples of different HF     pathogenesis. Both gain- and loss-of-function mutations of the same gene cause disease,     calling for disease-specific agonism or antagonism of this gene´s function. However,     mutations alone do not predict the severity of cardiomyopathies nor therapy, because their     impact on cardiac myocyte function is modified by numerous factors, including the genetic     context. Today, patient-specific cardiac myocytes can be evaluated by the induced pluripotent     stem cell (hiPSC) technology. Yet, unfolding the true potential of this technology requires     robust, quantitative, high content assays. The researchers' recently developed method to     generate 3D-engineered heart tissue (EHT) from hiPSC provides an automated, high content     analysis of heart muscle function and the response to stressors in the dish. The aim of this     project is to make the technology a clinically applicable test. Major steps are (i) in depths     clinical phenotyping and genotyping of patients with cardiomyopathies or HFpEF, (ii)     follow-up of the clinical course, (iii) generation of hiPSC lines (40 patients, 40 healthy     controls), and (iv) quantitative assessment of hiPSC-EHT function under basal conditions and     in response to pro-arrhythmic or cardio-active drugs and chronic afterload enhancement. The     product of this study is an SOP-based assay with standard values for hiPSC-EHT     function/stress responses from healthy volunteers and patients with different heart diseases.     The project could change clinical practice and be a step towards individualized risk     prediction and therapy of HF.   "
66344|NCT02417298|"     Pain associated with sickle cell disease is a common emergency department visit. It is also     frequently associated with a high emergency department recidivism rate for pain control and     admissions to the hospital. Opiates are considered the first line therapy for acute flares     and to manage chronic pain. This often times leads to a stigma of being opiate seekers or     frequent fliers. With this study, we wish to explore whether adding ketamine to standard     acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of opiates     while improving the patient's perception of pain. In addition, we will be exploring whether     ketamine as an adjuvant therapy can help reduce hospital admissions for the management of     acute sickle cell crisis pain.   "
66345|NCT02417285|"     CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and     expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of     CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary     efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory     objectives. In the dose escalation part, the safety and tolerability of increasing doses of     CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the     maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a     CC-122 dose selected from the escalation part of the study in combination with fixed dose     obinutuzumab to further study safety and efficacy.   "
66346|NCT02417272|"     Background : Cervical degenerative disc disease is frequent and the consequence of aging.     Degeneration may lead to disc herniation. Surgery is indicated in the presence of root     compression with cervicobrachial neuralgia and/or myelopathy.      Purpose: The main objective of the study is the comparison of efficacy between total disc     replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment     of symptomatic cervical degenerative disc disease in term of Success rate, defined as     preservation of adjacent segments, 24 months after surgery.      In our knowledge, there are no published data about randomized clinical trials comparing     these radiological parameters (worsening of degeneration signs on static cervical spine     radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery,     between these 2 surgical approaches in patients suffering from cervical degenerative disc     disease.   "
66368|NCT02416986|"     The goal of this study is to evaluate the effects of exposure to standard smoking     environments on ability to resist smoking as measured with a Delay to Smoking Task. The     results of this study will inform whether the Delay to Smoking Task is a sensitive measure     for evaluating environment-provoked craving and smoking behavior.   "
66369|NCT02416973|"     To demonstrate the analgesic effectiveness of 2 modalities of PEMF treatment compared to sham     treatment in patients with persistent pain following lumbar surgery when treatment is     administered twice daily over a 60 day period.   "
66348|NCT02417246|"     Recently, the quality of generic metoprolol extended-release (ER) (Toprol XL,     Activas,Wockhardt) products has been called into question with reports of inconsistent     effects when switching from the brand name product to a generic formulation. Problems with     how the body processes these drugs could have serious and widespread consequences given the     high frequency of metoprolol ER use in the management of various cardiovascular disorders,     including high blood pressure, coronary heart disease, heart failure, and cardiac     arrhythmias. Investigators hypothesize that both product- and subject-specific factors lead     to variability in the way the body breaks down the drug (pharmacokinetics) and clinical     response to generic versus name brand metoprolol ER formulation. Investigators will study the     brand name and generic metoprolol ER formulations in subjects with high blood pressure to     compare the pharmacokinetics and cardiovascular responses among equivalent labeled doses of     each product.      The study objective is to provide information on how the body breaks down generic and brand     name metoprolol ER products (pharmacokinetics) and how the body responds to generic and brand     name metoprolol ER products (pharmacodynamics) to better understand if generic metoprolol ER     products are as good as the brand name product.   "
66349|NCT02417233|"     This study will evaluate the efficacy of two strategies for enhancing overall preventive     behaviors, retention in HIV care, and adherence to medication for HIV positive individuals in     South Africa: SMS text messing and peer navigation services.   "
66350|NCT02417220|"     The purpose of this study is to conduct a randomized controlled trial to compare the weight     losses produced by the Weight Watchers Online program revised for 2015 (WWO2015) and WWO2015     plus the provision of an electronic scale and weekly email feedback on weight loss (WWO2015     Enhanced), over a 6-month period.   "
66351|NCT02417207|"     The purpose of this study is to observe a new scheme can achieve is the same as the     traditional scheme of the effect of preventing hepatitis B recurrence.   "
66398|NCT02416596|"     The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the     IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary     infertility.   "
66399|NCT02416583|"     To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor     induction for nulliparas at term with an unfavorable cervix   "
66353|NCT02417181|"     The aim of this study is to explore the effect of substituting General Practitioners (GPs) by     Physician Assistants (PAs) in out-of-hours primary care. Effects are measured in terms of the     implication for the care model, quality of care delivered by PAs in comparison to GPs; the     complaints treated by PAs in comparison to GPs; safety, efficiency and patient satisfaction.     Lastly, this study will provide insight in the changes in costs of healthcare.   "
66354|NCT02417168|"     Fevers raise the concern for serious bacterial infections in pediatric oncology patients     receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of     the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there     can be a false negative result.      Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to     identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in     differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology     patients. A reliable predictor of bacteremia infections in pediatric oncology patients should     decrease hospitalizations for fever and unnecessary antibiotic treatment.      In our study we will measure procalcitonin levels in pediatric oncology patients presenting     with fever. We will measure procalcitonin at the time of admission which is part of our     standard of care for febrile pediatric oncology admissions. For the purpose of our study, we     will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We     will examine procalcitonin levels at these three timepoints to determine if elevated     procalcitonin levels predict bacteremia in pediatric oncology patients with and without     neutropenia.   "
66355|NCT02417155|"     Inflammatory cytokines play a pivotal role in rheumatoid arthritis (RA) and innovative     non-pharmacological therapies aimed at limiting cytokine production are highly warranted.     Adrenaline, a neurotransmitter of the autonomic sympathetic nervous system, attenuates     cytokine production. Along these lines, endogenous modulation of sympathetic activity could     limit inflammation and therefore represent a treatment modality that would empower RA     patients to exert self-control over disease activity. However, both the autonomic nervous     system and the inflammatory response are regarded as systems that cannot be voluntarily     influenced. Nevertheless, results from two recent studies demonstrate that this is possible     through techniques developed by 'iceman' Wim Hof, namely meditation, exposure to cold, and     breathing exercises. Hof himself and healthy volunteers trained by him were able to     voluntarily activate the sympathetic nervous system, resulting in adrenaline release and     subsequent suppression of the inflammatory response during experimental human endotoxemia (a     model of systemic inflammation elicited by administration of lipopolysaccharide [LPS] in     healthy volunteers). Interestingly, while having been taught all three techniques, during the     endotoxemia experiment the trained subjects (like Hof himself) predominantly practiced the     breathing exercises consisting of two different techniques. A `hyper/hypoventilation`     technique, characterized by cycles of hyperventilation followed by breath retention and a     `strength ventilation` technique consisting of deep inhalations and exhalations followed by     breath holding. These techniques resulted in intermittent hypoxia and cyclic shifts in     acid-base balance. Based on these observations and previous studies, the investigators     hypothesize that these breathing techniques account for the increased production of     adrenaline and thus for the suppressed inflammatory response but it is unclear which of these     two techniques is most important.   "
66356|NCT02417142|"     This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly     injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine     exenatide's effects on negative symptoms and cognition.   "
66357|NCT02417129|"     This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator     trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in     patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2     of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4     dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the     End of Study (EOS) Visit at Week 30.   "
66383|NCT02416791|"     Stroke is the second cause of death worldwide and represented the first cause of death in     Brazil between 2006 and 2010. Most patients survive, and there is a need to develop     cost-effective rehabilitation strategies to decrease the burden of disability from stroke.     This study addresses this important issue, by combining two different interventions in the     early phase post-stroke: robotic therapy associated or not with transcranial direct current     stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor     upper limb rehabilitation.   "
66358|NCT02417116|"     Millions of people suffer from dry eye disease, causing symptoms such as redness, burning,     feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your     eyes do not produce enough tears or produce poor quality tears. This can happen for a number     of reasons, including aging, hormonal changes in women and side effects of diseases or     medications.      It is now possible to objectively measure the degree of dry eye disease by collecting a tiny     sample of tears from the corner of the eye and then measuring the amount of salt in the tears     (termed osmolarity). We aim to establish the overall levels of raised and normal tear     osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this     to other factors such as symptoms, topical and nutritional medication and dry eye treatment.   "
66359|NCT02417103|"     The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon     Liraglutide on the lipid metabolism an inflammation in adipose tissue.   "
66360|NCT02417090|"     Metformin in widely used as the treatment of gestational diabetes. However, it is not known     whether exposure to metformin in utero has late metabolic effects on the child.      In this study the investigators investigate metabolism (oral glucose tolerance test, insulin,     plasma lipoproteins, inflammation markers as well as body composition by DEXA (dual energy     X-ray absorption) and MRI) in 9 year-old children whose mothers used either metformin of     insulin during pregnancy.   "
66361|NCT02417077|"     This study will examine the perception of facial expressions among individuals with and     without crow's feet lines.   "
66362|NCT02417064|"     The purpose of this study is to compare the efficacy and safety of switching     treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to     which they have not responded) to either intranasal esketamine plus a new oral antidepressant     or switching to a new oral antidepressant plus intranasal placebo.   "
66374|NCT02416908|"     Selinexor has shown single-agent activity in a current phase I study enrolling patients with     relapsed/refractory AML with durable complete remissions (CR), complete remissions with     incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD)     observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were     manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity     in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen     without significant non-hematologic toxicity. Given the established role of CLAG     chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities,     the investigators propose a phase I/II open label study of selinexor in combination with CLAG     for the treatment of patients with relapsed/refractory AML.   "
66375|NCT02416895|"     The purpose of this study is to examine the relationship between Vitamin D status and     immunity.   "
66376|NCT02416882|"     This study tests whether different physical activity patterns are linked an individual's     genes.   "
66363|NCT02417051|"     The goal of this project is to adapt and test the efficacy of the National Institute of     Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program     for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to     improve resilience for stress reactions in active emergency responders. A total of 120     participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a     waitlist control condition. A three-month assessment period will be utilized to enable us to     evaluate the effects of the intervention. Participants assigned to the waitlist condition     will be offered the option to participant in the course following completion of the 3 month     wait period. It is hypothesized that, participants attending the DWRT program, as compared to     those in the waitlist condition, will show increased resilience at three months     post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more     positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and     depression symptoms. It is predicted that participants attending the DWRT program, as     compared to those in the waitlist condition, will demonstrate greater awareness of the mental     health effects of disasters, including the symptoms of PTSD and depression. It is predicted     that, participants attending the DWRT program, as compared to those in the waitlist     condition, will endorse more positive attitudes towards mental health care, including     willingness to seek treatment if needed.   "
66364|NCT02417038|"     Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are     given.Pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia     - is challenging to measure clinically.American Society of Anesthesiologist guidelines     recommend suitable respiratory monitoring for 24 hours post cesarean delivery (CD).      Use of capnograph will enable us to assess breath-by-breathe respiration in a population     receiving neuraxial opioids - potentially at risk for respiratory depression.      Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a     cohort following opioid neuraxial administration for CD.   "
66365|NCT02417025|"     The purpose of this study is to determine whether a scientifically validated treatment for     Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered     effectively to Veterans with Military Sexual Trauma (MST) related PTSD using     videoconferencing technology, which allows a therapist and patient who are not in the same     room as one another to communicate. The investigators are interested in learning if this form     of mental health service delivery is an acceptable alternative to traditional face-to-face     therapy delivered with the therapist in the same room as the patient. This study is being     conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient     Clinics (CBOCs), and will involve approximately 100 female participants.   "
66366|NCT02417012|"     This study evaluates the effect of a lifestyle intervention maintenance of glycemic control     while reducing glucose lowering drugs in patients with type 2 diabetes mellitus. The     intervention group receives an intensive lifestyle intervention including exercise and diet     lifestyle modifications. The reference group receives diabetes educational advice. Both     groups will have their pharmacological treatment regulated across the study. The primary     hypothesis is that lifestyle change is sufficient to maintain glycemic control while     decreasing the anti-diabetic medication in a sample patients with type 2 diabetes mellitus.   "
66367|NCT02416999|"     This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide     for recurrent high-grade gliomas.   "
66370|NCT02416960|"     Infertility has been currently recognized as a disorder related to obesity. Among several     metabolic changes associated with obesity, insulin resistance appears to be linked to     hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved     in energy balance regulation and are also associated with reproductive system regulation, but     its relationship with infertility is scarce. The aim of this study is to determine the effect     of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal,     metabolic and reproductive parameters in infertile overweight or obese women candidates to in     vitro fertilization. The patients who meet the inclusion criteria and accept to participate     in the study, will be allocated in one of the following groups: Hypocaloric Low Glycemic     Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual     diet) and follow the study protocol for 12 week. Immediately after the end of the diet     protocol, the patients will be submitted to the in vitro fertilization treatment.   "
66371|NCT02416947|"     This study is designed to study the dose response effect of continuous Soluble Corn Fiber     (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using     the 41Calcium methodology. To further understand the dose response effect of SCF bone     biomarkers will be studied.      Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent     manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone     biomarkers of resorption.   "
66372|NCT02416934|"     This prospective, randomized, double blind, controlled study evaluates the effect of     perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.   "
66373|NCT02416921|"     The purpose of this research study is to evaluate the effect of a Facebook-delivered     weight-gain prevention program versus a Facebook-delivered program with general women's     health information.   "
66377|NCT02416869|"     The aim of this randomized double-blind cross over clinical trial is to investigate     effectiveness of different routes of applications (intramuscular and submucous at the site of     surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of     life after lower third molar surgery.   "
66400|NCT02416570|"     This study aims to identify if clarithromycin (CLM) has potential as a widely available and     inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell     lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive     a placebo.   "
66378|NCT02416856|"     The integrity of structural connectivity supporting cortical regions in the left brain     hemisphere is hypothesized to enable treatment-induced naming recovery in persons with     language difficulties after a stroke (aphasia). We will map whole brain connectivity (i.e.,     the brain connectome) to investigate the role of cortical connectivity in impairment (Aim 1)     and recovery (Aim 2) in patients with aphasia undergoing treatment. This information will be     used to construct personalized markers of anomia treatment outcome (Aim 3), which may serve     as a guide for speech-language pathologists and neurologists when facing patient management     decisions.   "
66379|NCT02416843|"     Overweight and obesity are major problems and their complications such as cardiovascular     disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is     accumulating evidence to support obesity being a chronic inflammatory disorder mediated in     part by the expansion of adipose (fat) tissue.      Knowledge of the role of adipose tissue itself has changed dramatically and it has emerged     that in addition to storing energy as fats; adipose tissue secretes and responds to various     chemical messengers in the body that are related to metabolism and inflammation. After a meal     has been consumed, changes in metabolic (and some inflammatory) markers are seen in the     blood, which may be influenced by metabolic and inflammatory changes occuring in the adipose     tissue itself.      The investigators therefore plan to investigate these changes in adipose tissue before and     after a meal and compare them to changes occurring in the blood. They also plan to     investigate whether these responses are different in people who are overweight compared to     'normal' weight.      Participants will include males aged between 35-55 years who fit the criteria for inclusion.     After taking some preliminary measurements and monitoring of normal daily activities,     participants will attend one day of Laboratory testing in the Physiology Laboratories at the     University of Bath.      By investigating differences in metabolism and inflammation in adipose tissue and the     circulation it is hoped that more will be learnt about the development of diseases associated     with being overweight and ultimately help to develop more effective methods for prevention     and treatment.   "
66380|NCT02416830|"     The purpose of this cohort post market registry is to collect data and create a global     database on use of embolization devices and embolization procedures outcome. The data     collected in the cohort will serve a scientific purpose to acquire better insight in     embolization procedures. This will be achieved by publications in Scientific Journals and by     presentations at scientific meetings. Additionally it will support the industry on creating a     better overview of the products used to maintain and enhance the clinical efficacy of the     used devices. The cohort post market registry represents a novel approach in a way of     allowing Clinicians to generate reports based on an evolving controlled and well organized     database   "
66381|NCT02416817|"     The purpose of this study is to compare two already validated methods for massive transfusion     in trauma patients admitted to the emergency room of a large reference hospital.   "
66382|NCT02416804|"     Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine     transdermal system (MTDS) among the patients with lumbar spinal disease who was performed the     single-level posterior lumbar fusion.      After surgery, all the patients apply the patient-controlled analgesia. After three days of     surgery, patients are divided into two groups.Group A is an experimental group that     administer the BTDS after surgery, and Group B is a control group that take tramadol     analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional     rescue medicine, acetaminophen.      After the surgery, patient's pain score and quality of life would be recorded sequentially.     The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3     months, respectively.   "
66577|NCT02414269|"     The purpose of this Phase I study is to test the safety of different doses of specially     prepared immune cells (called T cells) collected from blood. The Investigators want to find     a safe dose of these modified T cells for patients who have malignant pleural disease. They     want to find out what effects these T cells have on the patient and the cancer (MPD).   "
66384|NCT02416778|"     Disordered iron metabolism characterizes an important determinant of impaired exercise     tolerance and work capacity. Iron-deficiency anemia commonly features impaired aerobic     capacity caused by decreased oxygen carrying capacity, and has been associated with a     negative effect on dyspnea and walking distance.      Apart from that, iron deficiency without anemia was shown to affect endurance and energetic     efficiency via decreased tissue oxidative capacity. Consequently, depleted iron stores could     be capable of causing fatigue, breathlessness and impaired exercise tolerance, which are     common features of chronic cardiopulmonary diseases like chronic heart failure (CHF) and COPD     (Chronic Obstructive Pulmonary Disease). Indeed, a current surge of interest aimed at     potential underlying determinants in CHF and COPD independent of the primarily disordered     organ.      Recent studies identified iron deficiency without anemia as an independent factor of reduced     exercise intolerance in CHF as well as in COPD. Moreover, intravenous iron application     significantly improved exercise capacity in CHF patients with iron deficiency in presence as     well as in absence of anemia. Comparable to CHF, the daily living of patients with COPD is     compromised by impaired exercise tolerance.      However, airflow limitation, as the foremost characteristic of COPD shows only weak     associations with exercise capacity. In line with that, exercise capacity showed no     remarkable improvement in lung transplant recipients, underlining the presence of systemic     determinants of limited exercise tolerance like iron deficiency. The investigators showed     that iron deficiency is present in 50% of stable COPD patients (unpublished data), which is     according to recently published data.      The investigators presume that iron deficiency contributes to limited exercise capacity in     COPD patients. Thus, the aim of this study is to determine whether iv iron is associated with     increases exercise capacity in COPD.      Therefore the investigators hypothesize that filling up depleted iron storages will increase     exercise capacity, measured by the 6-MWT (Minute Walking Test).   "
66395|NCT02416635|"     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in     liver cancer could play an important role in diagnosis, predicting the risk for tumor     recurrence, and providing novel target therapy biomarkers. In view of these facts, the     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting     human tumor cells of liver cancer in normal peripheral blood after cryosurgery with or     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)     method.   "
66385|NCT02416765|"     Postprandial meal glucose control with closed-loop systems (CLS) still needs some     improvements. In the postprandial period, sensor delay in detecting blood glucose rise after     a meal together with delays in insulin absorption expose patients to early risk of     hyperglycemia and then to late-postprandial hypoglycemia. Glucagon infusion in dual-hormone     CLS has the potential to improve post-meal control as compared to single-hormone CLS allowing     a better glucose excursion related to a more aggressive insulin infusion while minimizing     hypoglycemic risk. Several approaches have been tested for the determination of prandial     boluses during closed-loop operation.      The objective of this study is to test in outpatient unrestricted settings whether, in the     context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to     a simplified qualitative meal size estimation without a significant degradation in overall     glycemic control in adult patients with type 1 diabetes.      The investigators hypothesize that in outpatient free-living conditions: 1) Dual-hormone CLS     with partial boluses is equivalent to dual-hormone CLS with full boluses in terms of mean     glucose; 2) Single-hormone CLS with partial boluses is equivalent to single-hormone CLS with     full boluses in terms of mean glucose. Secondary hypothesis are: 3) Dual-hormone CLS with     partial boluses will decrease time in hypoglycemia compared to single-hormone CLS with     partial boluses; 4) Dual-hormone CLS with partial boluses is better than sensor-augmented     pump therapy in terms of mean glucose; 5) Single-hormone CLS with partial boluses is better     than sensor-augmented pump therapy in terms of mean glucose.   "
66386|NCT02416752|"     Opioid tolerance in the perioperative period is inevitable especially with ultra-short acting     agents such as remifentanil. Existing evidence had shown that opioid induced hyperalgesia due     to neuroplastic changes in the central as well as peripheral nervous system leads to     sensitization of pro-nociceptive pathways. However there has been a controversy of occurrence     of such tolerance following the use of remifentanil and the quality of recovery as compared     to conventional opioids. The investigators evaluated the occurrence of opioid tolerance and     other significant adverse effects with remifentanil in subjects undergoing head and neck     surgeries. The investigators studied ASA physical status I and II adult subjects undergoing     elective head and neck procedures, under general anesthesia with minimum expected duration of     2 hours. The remifentanil infusion was used in one group and intermittent boluses of morphine     or fentanyl administered in another group. They were evaluated for immediate post-operative     pain by using numerical rating scale (NRS), the opioid consumption, post-operative nausea,     vomiting, other significant adverse effects of remifentanil and the time to discharge from     PACU.   "
66387|NCT02416739|"     Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate     epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer     cells. Nicotinamide was found to be effective in several animal cancer models including lung,     bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also     effective in the treatment of human lung cancer.   "
66388|NCT02416726|"     The objective of the study was to compare the gene mutation status among the primary tumor,     matched metastatic lymph node (LN) and peripheral blood in advanced nonsquamous non-small     cell lung cancer (NSCLC) using next-generation sequencing (NGS).   "
66389|NCT02416713|"     Research participants will be recruited to take part in a randomized control trial.     Participants' cellphone use will be observed during an initial baseline period. Participants     will then be randomly assigned to one of four conditions: education only (control), opt-in     blocking, opt-out blocking, and opt-out blocking with parental notification.   "
66422|NCT02416284|"     The Norwegian Directorate of Health recently published the Norwegian food-based dietary     guidelines (NFBDG) in 2011. The target for the NFBDG is the general population, and the main     aims of these guidelines are to promote public health and prevent chronic degenerative     diseases. Reaching the healthy population is crucial as only small proportion of the general     population comply to the current public dietary advice in Norway. Thus, the objective of this     study is to investigate whether a multi-faceted dietary intervention could increase     compliance to the NFBDG and affect biomarkers of chronic degenerative diseases in a healthy     population.   "
66423|NCT02416271|"     The main purpose of this study is to evaluate the effects of teriparatide with those of     alendronate on spine bone mineral density (BMD) and other osteoporosis factors in     postmenopausal women with osteoporosis.   "
66424|NCT02416258|"     The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray     compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol     spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.   "
66390|NCT02416700|"     The main objective of this prospective, controlled, and randomized clinical study is to     evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded     implants with a single prosthesis. A split-mouth experimental design will be used, and the     success rate of the installed implants will be determined. Twelve selected patients     (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental     implants. The protocol for preparing the surgical sites will be based on the manufacturer's     recommendations and bone density. Patients with an initial torque less than 30 N·cm and an     implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes,     indicating which site is the test site, will be opened after the implants are installed.     Transfer impressions of the implants receiving immediate loading will be produced so that     temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after     the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal     adjustment will be made to ensure minimal contact at maximum intercuspation and absence of     contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of     implant installation) and 3, 6, 9, and 12 months after implant installation, the following     aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell     ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility     of the implant, crestal bone loss around the implant (as determined by x-ray evaluation),     probing depth around the implant, and periodontal pain.   "
66391|NCT02416687|"     The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy     recurrence, especially in vulnerable populations. A limitation to recommending this practice     universally is the low quality of evidence on the effect of the ENG implant on breastfeeding     when inserted immediately postpartum. This study is the first assessing the impact of     inserting the ENG implant immediately postpartum on the amount of milk using the gold     standard method for this purpose.   "
66392|NCT02416674|"     Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a     deceased human donor to a patient with a large abdominal wall defect. Abdominal wall     transplantation is an innovative reconstructive procedure that has the potential to     significantly improve the lives of patients with large abdominal wall defects. The purpose of     this study is to develop the best practices for abdominal wall transplantation that will     improve the outcomes of future abdominal wall transplant recipients.   "
66393|NCT02416661|"     This study should demonstrate the correlation and predictive value of lyso-Gb1 concentration     with the clinical severity of naïve, initially non-ERT/SRT Gaucher disease type 1 and during     the study ERT/SRT-newly started Gaucher type 1 patients   "
66394|NCT02416648|"     The purpose of this study was to determine the effectiveness of a clinician client centered     counseling on knowledge on HIV transmission and prevention, attitudes towards HIV/AIDS, and     sexual behaviors of adult HIV patients enrolled in care in Yola, Nigeria.   "
66401|NCT02416557|"     Intraoperative hypothermia is associated with many clinical adverse outcomes. Many techniques     were applied to prevent intraoperative hypothermia, and positive end-expiratory pressure     (PEEP) has been known to blunt intraoperative hypothermia by increasing thermoregulatory     vasoconstriction threshold. The investigators assessed the effect of PEEP on the prevention     of intraoperative hypothermia during spine surgery in prone position.   "
66402|NCT02416544|"     The aim of this study is to evaluate the effectiveness of Low Calorie Low Salt Lunch for     Weight Reduction in overweight or obese workers of a health promoting hospital.   "
66403|NCT02416531|"     Vulvar lichen sclerosus (VLS) is a lymphocyte-mediated disease of unknown etiology that can     cause intense itching as well stenosis, hindering the evacuation and urination. It can also     limit the sex life due to severe local pruritus, pain and dyspareunia (pain during sexual     intercourse). The standard treatment for this disease is the use of topical corticosteroids     to reduce the clinical symptoms and to try to increase disease-free intervals. Photodynamic     therapy (PDT), a treatment that associates a light radiation with a photosensitizing agent     and low-level laser therapy (LLLT) are therapies that can promote effective immunomodulatory     responses at the application site by means of photophysical and photochemical phenomena from     the molecular to the systemic level, which promote their use in chronic dermatoses. The aim     is to study and compare the effects of PDT, LLLT, and topical corticosteroid in VLS     evaluating clinical, histological, immunohistochemical and spectroscopic responses. The study     will be prospective, randomized, and controlled, in a population of 60 women with     histological diagnoses of VLS, enrolled on the outpatient clinic of Genitoscopy Department of     the Pérola Byington Hospital in São Paulo. There will be 3 treatments groups: PDT, LLLT and     topical corticosteroid, where will be allocated by randomization 20 patients in each one. The     clinical course will be monitored by measuring local temperature, itching, clamping     (atrophy), and the appearance of the lesion. Histologically, the slides will be classified     according to the Hewitt grading and will have the ordering of collagen fibers quantified.     Immunohistochemical analysis will be done using the markers IFN-γ, TGF-β, CD4, CD8, IL-1, p53     and Ki-67. Finally, the spectroscopic evaluation will be done by reflectance. Descriptive and     inferential statistical analyses will be conducted to compare the groups and for associations     between different responses.   "
66404|NCT02416518|"     Genetic Exploration of the Molecular Basis of Malignancy in Adults.   "
66405|NCT02416505|"     This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.      In this study, the investigators aim to evaluate the impact of a visual aid on patient     comprehension an orthopedic informed consent discussion in low socioeconomic populations.      The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple     Choice Questionnaire.      The secondary outcomes include: Patient satisfaction and Time efficiency.      The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic     informed consent discussion will improve patient comprehension, satisfaction and     time-efficiency of orthopedic care.   "
66406|NCT02416492|"     The primary purpose of the clinical study is to evaluate the clinical efficacy of     intracranial administration of SB623 cells on patients with chronic motor deficit from     Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of     intracranial administration of SB623 cells on disability parameters and 2) to evaluate the     safety and tolerability of intracranial administration of SB623 cells. Patients with stable,     chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.   "
66425|NCT02416245|"     The aim of the current study is to investigate the beneficial impact of 4 month consumption     of a beverage powder fortified with Brahmi (Bacopa monnieri) extract and multiple vitamins     and minerals on short term memory as assessed using standardised cognitive test battery.   "
66591|NCT02414087|"     Using double blind, randomized controlled design to study the short-term therapeutic effects     of customized arch-support shoe insoles to children with flat foot.   "
66407|NCT02416479|"     With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and     test interventions that increase medication adherence (MA) in chronically ill adults. Among     adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading     predictor of poor outcomes, including rejection, kidney loss, and death. An alarming     one-third of KT patients experience MNA even though the problem is preventable. Adherence     intervention studies have proven marginally effective for those with acute and chronic     illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design     with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE     intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This     intervention shows great promise for increasing MA with a large effect size of 1.4 in our     pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically     improve MA behaviors by identifying and shaping routines, involving supportive others in     routines, and using medication taking feedback through small patient-lead experiments to     change and maintain behavior. The Medication Event Monitoring System cap, which contains     microelectronics that record the date and time of the cap removal, will be used to measure     MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA     between the two groups during the 6-month maintenance phase. Mediators and moderators of MA     will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be     conducted.   "
66408|NCT02416466|"     This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions     and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.   "
66409|NCT02416453|"     The purpose of this study is to evaluate the safety and tolerability of 3 vaccination     schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as heterologous     prime-boost regimens.   "
66410|NCT02416440|"     Type 2 diabetes (T2D) is an emerging epidemic in sub-Saharan Africa, with an estimated     prevalence of 6%. With around seven million cases of T2D in 2000, it is anticipated that over     18 million Africans will have the disease by 2030. In South Africa the prevalence of T2D in     people of African descent has been reported to be between 3-10%. However, there have been     limited studies on diabetes epidemiology in South Africans using currently employed World     Health Organization (WHO) criteria.      To assess the burden of T2D and associated risk factors in South Africa, we are establishing     the Durban Diabetes Study (DDS) - a population-based cross-sectional study in the city of     Durban (the eThekwini municipality) to be undertaken in 1,200 participants of African     descent. In-depth health questionnaire responses, biophysical measurements and blood and     urine samples will be gathered from these participants. These data will allow researchers to     estimate the population prevalence of T2D and associated risk factors in the region. The     infrastructure created for this cross sectional study has the potential to serve as a strong     framework for future research initiatives and public health interventions within the region.   "
66411|NCT02416427|"     This pre-surgical, window-of-opportunity study is designed to investigate whether     atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer     TAZ.   "
66412|NCT02416414|"     To compare the performance of the QuantiFERON Monitor assay against existing methodology.   "
73150|NCT02328300|"     This is a single arm, single center study of 15 patients with brain lesions being treated at     UNC Hospitals. Subjects will undergo one (1) FLT-PET-MRI scan before their scheduled surgical     biopsy of their brain lesion(s).   "
66413|NCT02416401|"     Healthy aging is associated with a decline in multiple cognitive domains, as well as motor     control function. The long-term consequences of cognitive and functional impairment resulting     from age-related cognitive decline are well documented in the scientific and clinical     literature, with significant evidence of related problems with independent functional     abilities. This study aims to understand how the experimental computer program can affect     cognition and attention in participants with age-related cognitive decline.   "
66414|NCT02416388|"     This open label, multicenter phase II/III study with multiple randomization phases at     differents stages of AML treatment (induction, consolidation and HSCT where applicable) is     designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient     strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following     allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC)     conditioning, will also be evaluated. With an adaptative design, this clinical trial could     test up to 3 novel AML agents of interest.   "
66415|NCT02416375|"     The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a     number of parameters on a daily basis at home which might predict respiratory infections     before they have symptoms and which might also predict treatment failures before this is     obvious with conventional measures.   "
66416|NCT02416362|"     The purpose of this study is to analyze the immediate effects of two exercise protocols on     the vibration platform, on the strength of the thigh muscles, joint position sense of the     knee and balance in healthy subjects.   "
66417|NCT02416349|"     The purpose of study is to evaluate the acute effects of respiratory muscles stretching on     ventilator pattern and volume distribution of chest wall in patients with right hemiparesis     post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the     respiratory function.   "
66418|NCT02416336|"     The aim of this study is to investigate whether the Sentinella camera improves intraoperative     detection and removal of sentinel lymph nodes (SLNs) when used in conjunction with standard     detection methods. Of primary interest is whether the Sentinella camera identifies additional     tumor-positive SLNs that are missed using traditional imaging techniques. Other outcomes     related to the standard of care use of the Sentinella camera may also be assessed.   "
66419|NCT02416323|"     The purpose of this study is to test the effectiveness of training community mental health     therapists to deliver a mental health intervention for ASD (AIM HI) and study the process     of implementing AIM HI in community mental health programs.   "
66420|NCT02416310|"     To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during     perioperative could alleviate the postoperative gastrointestinal complications after cesarean     section under combined spinal epidural anesthesia compared with control and non-acupoint     group.   "
66426|NCT02416232|"     This is a single arm open label, multicenter, non randomized, access study of trametinib for     subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive     mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV).     Trametinib may be given as monotherapy or in combination since first line metastatic melanoma     as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they     have not progressed under such treatment or if they have presented limited progression as per     eligibility criteria. It is estimated that between 250 and 400 subjects with histologically     confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced     unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.   "
66427|NCT02416219|"     Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients     undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent     aspiration. Using Ultrasound guidance we will be assessing the ability of different     disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients     by anatomical landmark palpation.   "
66428|NCT02416206|"     High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the     up-front treatment of patients with multiple myeloma has been associated with improved     disease-free and overall survival in multiple large randomized controlled trials. Following     3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose     Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70     years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care     preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing     Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results     to single-agent Melphalan with higher toxicity.   "
66429|NCT02416193|"     Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5     times higher in persons with diabetes than the general population. There is evidence that     cognitive decline significantly impacts the ability to self-manage diabetes. Strategies to     prevent cognitive decline in persons with diabetes has not been well studied. A recent study     reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and     Alzheimer's was doubled. Vitamin D receptors are located in the brain and deficiency of     vitamin D has been reported to negatively affect the development of brain. Therefore,     providing vitamin D supplementation to improve cognitive function is worthy of study. The     investigators propose a small, randomized controlled trial to determine the effects of     vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive     impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation     (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months. The study aims     are to determine (1) the effect of vitamin D3 supplementation on cognitive function and (2)     the effect of vitamin D3 supplementation on diabetes self-management. A sample of persons     with type 2 diabetes (n=62), who have a subjective complaint of a cognitive dysfunction or     scoring at least one standard deviation below normal on a cognitive functioning screening     test, have vitamin D levels less 30 ng/ml, are not depressed (as this impacts cognitive     function), and do not have severe diabetes complication will be recruited. Participants will     be phone screened and complete two baseline visits prior to randomization. They will then     have phone call and follow-up visits to assess (1) cognitive function using standardized     tests to assess for executive function (2) serum measurements (HBA1c, fasting glucose,     vitamin D levels, and cardiometabolic profile) and (3) surveys to assess cognitive function     as well as self-management behaviors.   "
66430|NCT02416180|"     This study aims to explore the potential impact of switching inhalers by assessing the     handling error rate (critical and non-critical) in controlled asthmatics currently treated     with, and using correctly, SERETIDE via the DISKUS Inhaler who are switched to receiving     SERETIDE via the Metered Dose Inhaler (MDI) (EVOHALER) without training by a Healthcare     Professional (HCP).      This will be a descriptive, multi-centre, open-label, non randomized 14 day study assessing     MDI technique in subjects with controlled asthma (Asthma Control Test [ACT] score >= 20 at     Visit 1) currently treated with, and able to use correctly, SERETIDE via the DISKUS Inhaler.     All the eligible subjects will be switched to an equivalent dose of SERETIDE via the MDI.     Subjects will need to use the MDI inhaler in accordance the accompanying patient information     leaflet (to be read prior to use) for approximately 14 days. No instruction, coaching or     comment on inhaler technique will be provided by the HCP. MDI technique of subjects will be     assessed at Visit 2 (after 14 days) and the errors will be recorded. Subject will revert back     to using their SERETIDE DISKUS inhaler again from Visit 2. Subjects will be followed up by     telephone for approximately 1 week after Visit 2.      A maximum of 110 subjects will be enrolled such that approximately 100 evaluable subjects     complete the study. The total duration of the study for each subject will be approximately 21     days.      SERETIDE, EVOHALER and DISKUS are registered trademarks of the GlaxoSmithKline (GSK) group of     companies   "
66431|NCT02416167|"     The purpose of this study is confirmatory investigation of safety and efficacy (dose response     and optimal dose according to the percent reduction from baseline in serum urate level at the     final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout     for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8     weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind,     parallel group comparison.   "
66432|NCT02416154|"     The proposed study aims to determine the expression of Interferon-ε (IFNε) in the female     genital tract, which has never been mapped before in humans. High expression in other     mammalian female reproductive tract (FRT) has been suggested to be important in anti-sexually     transmitted infection (STI)/HIV immunity and its expression decreases with progestogen     treatment. Future studies are planned to understand if hormonal contraceptives affect the     presence of interferon in the healthy female genital tract, potentially changing the risk of     for STI and HIV.   "
66433|NCT02416141|"     If a termination of pregnancy procedure is performed by vacuum aspiration our patients     receive a paracervical block. Nevertheless these patients are not free of pain. We randomised     our patients: one group will receive additional orodispersible tramadol, the other group will     receive a placebo.   "
66434|NCT02416128|"     The investigators plan to use an herbal eye drop, Euphrasia, aka Eyebright, for     post-operative inflammation for Peripheral Laser Iridotomy for the treatment of narrow angle     glaucoma. A peripheral Laser Iridotomy is a simple laser procedure with few complications if     the patient follows the post-operative instructions. In this procedure, a blue-green Argon     laser is used to create an orifice in the iris to open the angle by allowing the aqueous from     behind the iris to enter the anterior chamber. Rarely the procedure needs to be repeated. The     main complications from this surgery are postoperative inflammation, bleeding, and     postoperative pressure spikes.      The investigators will be using Weleda's Euphrasia D3 eye drops. The investigators plan to do     a double blinded randomized control trial to objectively measure ocular inflammation in the     same process that was used for the steroid eye drops that are currently out on the market.     Some patients will be receiving steroids, prednisolone acetate, others, the herbal eye drop.   "
66435|NCT02416115|"     Postoperative nausea and vomiting (PONV) is one of the most undesirable complications after     general anesthesia, and may lead to increased hospital stay and health care costs. The risk     factors for PONV include sex (female population), nonsmoking status, past history of motion     sickness and/or previous PONV, duration of anesthesia and surgical type (particular     gynecologic surgery) and postoperative use of opioids. The overall incidence of PONV has been     reported to be 30% with considerable variability, but can increase up to 69%- 80% in women     undergoing gynecologic surgery with general anesthesia and morphine-patient controlled     analgesia (PCA). Serotonin receptor antagonists (5-HT3) have been suggested one of the first     line therapies for preventing PONV because of their efficacy and few side effects compared     with other antiemetics. However, despite the use of this treatment, the incidence of PONV has     been reported to be between 48 % and 50%. Naloxone is a drug used to counter the effects of     opioid. It was found that administration of low dose naloxone prevents opioid side effects     such as nausea and pruritus without affecting analgesia or opioid requirements in patient     receiving morphine PCA. It was reported that the use of two antiemetic acting at different     mechanisms is better to prevent PONV than monotherapy.      Therefore, this prospective, randomized, controlled study was designed to investigate the     antiemetic efficacy of combination of ramosetron and premixture of naloxone with morphine PCA     after gynecologic surgery.   "
66501|NCT02415257|"     The purpose of the study is to determine whether vestibular and postural compensation     following schwannoma surgery is improved by ablating vestibular function prior to surgery,     even if vestibular function is absent according to modern assessment techniques   "
74886|NCT02305563|"     The purpose of this study is to determine the safety and effectiveness of ulocuplumab in     combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid     Leukemia (AML).   "
66436|NCT02416102|"     This is a proof of concept, open label protocol to evaluate the effect of losartan on     cigarette smoke-induced lung injury in smokers, ex-smokers with and without chronic     obstructive pulmonary disease (COPD), giving 50 mg and subsequently 100 mg losartan for 4     weeks      Aim: To test that inhibition of T-cell growth factor (TGF-ß) with losartan in ex-smokers with     COPD and active and passive smokers without COPD will lead to an increase chloride     conductance through calcium-activated chloride channel (CACC), as measured by nasal potential     difference (NPD).      Study design: The Investigators will assess the consequences of active and passive smoking     and the treatment with losartan on CaCC-mediated chloride conductance in human beings using     NPD measurements.      NPD is a direct measure of ion transport. It measures CaCC-mediated Cl- secretion and thus     serves as an indirect measure of voltage-dependent potassium (BK) channels function. In     addition, improvement of NPD measured ion transport was indirectly linked to lung function     improvements and clearance in trials with cystic fibrosis patients. Therefore, NPD lends     itself as a good surrogate for Mucociliary clearance (MCC), in a proof of concept clinical     trial.      The investigators will also measure TGF-ß levels in nasal secretions and cells to correlate     these with the level of CaCC-mediated Cl- conductance.   "
66437|NCT02416089|"     The purpose of the study is to evaluate the safety, feasibility and applicability of a new     device 'Tampostat' in the management of primary postpartum hemorrhage and compare the     efficacy of 'Tampostat' in terms of arresting primary PPH with that of the conventional     condom catheter.   "
66438|NCT02416076|"     Up to 40 subjects will be enrolled, randomized and treated. Enrolled subjects will receive     one, split-face Ulthera® treatment on the face and neck using a standard transducer on one     side of the face and a simulines transducers on the other side of the face. Follow-up visits     will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment,     immediately post-treatment, and at each follow-up visit.   "
66439|NCT02416063|"     The aim of this prospective randomized double-blind study was to compare the analgesic     efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine     for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.   "
66440|NCT02416050|"     Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three     month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated     with relapse to cocaine use.   "
66441|NCT02416037|"     Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using     PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration,     prevention of opening and closing of terminal respiratory units at minimal hemodynamic     compromise. The challenge is to carry out these objectives in a patient-centered approach     based on individual characteristic of lung pathophysiology. Recently, it has been proposed to     set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is     obtained from the difference between airway pressure and measured esophageal pressure (Pes).     Measured Pes values have been found positive in the supine position in ARDS patients, leading     to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up     to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under     investigation. Prone position ventilation significantly improves survival in severe ARDS as     demonstrated by meta-analyses and a recent multicenter randomized controlled trial.      The purpose of present project is to investigate Ptp at end-expiration in the prone position     in severe ARDS. The project is centered on the question about what are the values of measured     Pes in prone position. The hypothesis is that they are lower than in the supine position due     to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal     lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume,     overall lung recruitment (pressure-volume curve), and regional recruitment by using     electrical impedance tomography. will be assessed in supine then in the prone position across     two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.   "
66456|NCT02415842|"     The purpose of this exploratory, retrospective laboratory study is to assess the humoral     immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes     following administration, in adults and children, of GSK Biologicals' adjuvanted and     unadjuvanted pandemic influenza vaccines, using archived serum samples from previously     completed clinical trials.   "
66457|NCT02415829|"     The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX)     in patients with local advanced colorectal cancer.   "
66442|NCT02416024|"     Induction of general anesthesia to the patient could be a challenging period of anesthesia     management. Due to autonomic system suppression, hemodynamic fluctuation, such as hypotension     or hypertension, is commonly seen during this period. Furthermore, it has been observed that     a fraction of patients who develop hypotension may be refractory to vasoactive medications to     attempt to restore the systemic arterial blood pressure back to an acceptable level.      Previous studies have shown that patients chronically taking angiotensin converting enzyme     (ACE) inhibitors have a higher incidence of developing hypotension under general anesthesia     as well as being refractory to adrenergic vasoconstrictor medications given to help restore     systemic blood pressure. Interestingly, not all patients taking ACE inhibitors have shown the     described hemodynamic response after induction of general anesthesia. Therefore,     investigators are attempting to identify what changes in vascular physiology in those     patients may contribute to acute refractory systemic hypotension. Specifically, investigators     wish to explore whether differences in baseline levels of arterial stiffness potentially     contribute to this phenomenon. Arterial applanation tonometry is a non-invasive technique     that has been shown to reliably provide indices of arterial stiffness. In the proposed     project, applanation tonometry will be performed on the right carotid and femoral arteries to     assess carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor     system, AtCor Medical, Sydney, Australia) The measurement will be obtained before induction     of general anesthesia in the pre-surgical area. During induction of general anesthesia with     standard induction agents, brachial blood pressure will be measured by a cuff every minute up     to 10 minutes after tracheal intubation. A hypotensive response to anesthesia will be defined     by a systolic arterial blood pressure below 90mmHg upon induction. Hypotensive patients that     do not respond to vasoconstrictor medications (i.e. requires more than 200 mcg phenylephrine     to maintain systolic arterial blood pressure above 90 mmHg) will be classified as 'refractory     hypotensive. Using non-invasive applanation tonometry, we will be able to examine if aortic     stiffness has a propensity to become refractory hypotension after induction of general     anesthesia. This information will potentially help identify future patients that might be at     greater risk of developing refractory hypotension in response to induction of general     anesthesia.   "
66443|NCT02416011|"     The purpose of this study is to develop and test a series of booklets designed to assist     smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting     smoking and remaining smoke-free.   "
66444|NCT02415998|"     The aim of this study is to assess whether transesophageal echocardiography (TEE) can be used     to successfully guide an epidural catheter to a targeted thoracic level in pediatric     patients. The catheter will be placed in the epidural space under real-time TEE imaging and     assistance by a trained TEE operator (this could include an anesthesiologist or     cardiologist).   "
66445|NCT02415985|"     To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg     thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients   "
66446|NCT02415972|"     Stroke, a personal, familial, and social disaster, is the first cause of acquired disability,     the second cause of dementia, and the third cause of death worldwide. Its associated     socio-economic costs are astronomic. The burden of stroke is likely to increase, given the     aging of the population and the growing incidence of many vascular risk factors. Therefore,     apart from further development of stroke prevention and treatment strategies, rational and     effective tools for diagnosis, monitoring, and follow-up for stroke patients have potential     high long-term clinical and economic consequences.      For neuroradiological work-up, computed tomography (CT) or magnetic resonance imaging (MRI)     are used as gold standard techniques to detect presence or absence, effective state, and     extent of stroke. However, these techniques achieve simply a baseline study of ischemia     occurred and can deliver only a snapshot of brain parenchyma and vessels. Furthermore, their     rapid and actual availability, especially in primary hospitals, and their dynamic     capabilities and predictive values for further infarction are poor with critically ill     patients have to be repeatedly transferred to the scanning unit for each measurement. Whereas     CT examination is associated with x-ray radiation and may miss early detection of stroke, MRI     is associated with higher costs and not generally routinely and around-the clock available in     all the hospitals. Therefore, a simple, fast, repeatable, non-hazardous, and non-invasive     dynamic bedside tool for the detection of acute brain tissue hypoperfusion and monitoring for     potential further infarction or efficacy of thrombolysis either by systemic intravenous     thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) or by selective     intraarterial fibrinolysis and mechanical recanalization, both combined with or without     bridging after acute ischemic stroke, is strongly needed.      A promising alternative method of diagnosing stroke represents contrast-enhanced ultrasound     perfusion imaging (UPI). What makes UPI so valuable is the advantage of repeatedly and     non-invasively detecting brain tissue at risk for infarction by dynamic direct brain tissue     perfusion assessment and not by surrogate parameters, like blood flow velocity or vessel     diameter. Because of the possibility to screen and repeatedly measure the state of perfusion,     the chances increase to diagnose and monitor ischemic stroke and to define the appropriate     window for treatment. The perfusion analysis would also allow determination of treatment     results and guidance of rapid and adequate further therapy.      Therefore, the present pilot study in 40 patients is initiated. The objectives of this     observational diagnostic cohort trial are to evaluate feasibility and practicability of     repeated bedside assessments by contrast enhanced UPI in acute ischemic stroke patients and     to assess whether UPI can detect alterations in brain tissue perfusion before and after     recanalising therapy of strokes. Assessment of cerebral perfusion by CT or MRI serves as     reference and its results are compared to UPI data.   "
66447|NCT02415959|"     The objective of this study is to assess the efficacy and safety of different doses of Creon     Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant     (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).   "
66448|NCT02415946|"     BACKGROUND Tooth loss impairs the OHRQoL. Dental implants have expanded treatment options of     edentulous patients and improved their OHRQoL, however, in the posterior maxillary sextants     the possibility to place implants of desired length and diameter could be limited. lSFE and     tSFE represent two surgical options to vertically enhance the available bone in the     edentulous posterior maxilla. Invasivity, relevant postoperative discomfort, high costs, and     long times needed for the finalization of the prosthetic rehabilitation, however, strongly     limit the indications of lSFE and support the need for less traumatic procedures with similar     clinical effectiveness and reduced morbidity. In 2008, the investigators proposed a     user-friendly, safe, predictable and effective minimally-invasive procedure for tSFE, namely     the Smart Lift technique.      AIMS/OBJECTIVES The general aim of the present project is to validate the Smart Lift     technique as a simplified and minimally-invasive procedure for the implant-supported     rehabilitation of patients with edentulous, atrophic maxillary posterior sextants.      METHODS In a multicenter RCT study design, the reconstructive (clinical) and patient-centered     outcomes of tSFE performed according to the Smart Lift technique will be compared with those     of conventional lSFE.      EXPECTED RESULTS The Smart Lift technique should allow for a significant reduction of     treatment time, post-surgery complications and costs and an increase in the satisfaction     perceived by the edentulous patient with implant-supported rehabilitation, while maintaining     a clinical efficacy as well as a similar or lower morbidity and discomfort when compared to     lSFE. In other words, the investigators expect that more favorable risk-benefit and     cost-utility ratio, as well as a better performance in terms of pain, comfort, physical,     social and psychological effects of oral health, and issues concerning the OHRQoL, will be     observed for the Smart Lift technique compared to lSFE.      List of Acronyms (in alphabetical order) OHRQoL: Oral Health - Related Quality of Life lSFE:     sinus floor elevation with a lateral approach RCT: randomized controlled trial tSFE: sinus     floor elevation with transcrestal approach   "
66449|NCT02415933|"     This study tests the effects of family-based economic empowerment intervention, alone and in     combination with child rights sensitization component, on child protective outcomes among     ultra-poor families in Nord Region, Burkina Faso.   "
66450|NCT02415920|"     This study investigates whether oxytocin, a neuropeptide known for its role in social     bonding, influences the outcomes of persuasive communications. Participants will be given     either oxytocin or a placebo. Then, participants will view several videos discussing opinions     that they agree and/or disagree with. Participants' physiological and psychological responses     to the videos in the different conditions will be compared.   "
66451|NCT02415907|"     The purpose of this study is to investigating the absorption, metabolism and excretion of     radio labelled single doses of idalopirdine in healthy men.   "
66452|NCT02415894|"     The goal of this study is to examine the effectiveness and feasibility of a     mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in     Ukraine.   "
66453|NCT02415881|"     Phase I trial to evaluate the safety of escalating dose levels of conjugated     panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that     undergo surgery with curative intent.   "
66454|NCT02415868|"     This purpose of this study is to collect vaginal microbial samples of postmenopausal women to     assess the optimal conditions for cultivation and storage of the vaginal microbiota. These     samples will subsequently be used to develop a high-throughput assay that mimicks the vaginal     microbial community of postmenopausal women. This assay will be used to select and screen     compounds that can affect the vaginal microbiota and subsequently affect related symptoms     such as vaginal dryness.   "
66455|NCT02415855|"     Study Design:      This is a multicentre, prospective, open-label, single arm, phase IV registry study. No     additional procedures are included in the study. Standard clinical data will be collected.     This will include a physical examination and NIHSS score assessment at baseline. In addition,     all neuro-imaging will be collected. Standard imaging includes a non-contrast CT brain at     baseline and 7±2 days post-treatment. Repeat NIHSS score assessment at the time of the 7 day     CT scan. Repeat clinical and NIHSS score assessment 30 days post-enrolment will also be     collected when performed as part of standard care.      Study Objectives:        1. Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in patients          with atrial fibrillation.        2. Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of          dabigatran treatment following stroke/TIA        3. Determine the effect of asymptomatic hemorrhagic transformation on functional and          neurological outcome at 30 days.   "
66458|NCT02415816|"     Children with sarcomas are routinely assessed with a variety of imaging techniques that     involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone     scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many     imaging studies at the time of diagnosis, during therapy and for years following completion     of therapy. Because children are in a stage of rapid growth, their tissues and organs are     more susceptible to the harmful effects of ionizing radiation than are adults. Furthermore,     compared to adults, children have a longer life expectancy and, therefore, a longer period of     time in which to develop the adverse sequelae of radiation exposure, such as the development     of second malignancies.      Alternative experimental methods of measuring tumor response will be compared to current     standard of care measures to determine if the experimental method is equivalent to methods     currently being used. Investigators wish to determine if they can reduce patient's exposure     to the harmful effects of ionizing radiation by replacing imaging studies that use radiation     with whole body diffusion weighted magnetic resonance imaging (DW-MRI) which does not use any     radiation. They also want to know if DW-MRI measurements of the tumor can tell how well the     tumor is responding to therapy. There have been studies in adults with cancer that have shown     that DW-MRI provides useful information about how tumors are responding to therapy. There     have only been very small studies of DW-MRI in children with tumors in the body. Therefore,     the role of DW-MRI in pediatric sarcoma patients is not yet known and it is still     experimental. This study might give us important information that could help us treat other     children with bone or soft tissue sarcomas in the future.   "
66502|NCT02415244|"     The aim of this prospective observational study is to assess whether transesophageal     echocardiography (TEE) can be used to identify the structures within the vertebral foramen of     the spinal column and to determine the range of spinal segments which can be visualized.   "
66503|NCT02415231|"     The study is to see if watching humor and laughing can affect CRP levels in healthy     individuals. This is a randomized controlled trial.   "
66459|NCT02415803|"     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used     clinically for the prevention of atherothrombotic events in patients with acute coronary     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT)     have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to     clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment     elevation. These recommendations are primarily based on large, randomized, Phase III clinical     trials. However, few East Asian patients (or those of East Asian descent) have been included     in these trials to assess the use of these drugs. In addition, a growing body of data     supported that East Asian might have different adverse event profiles (thrombophilia and     bleeding) and therapeutic window compared with white subjects. Furthermore, East Asian     paradox phenomenon has been described that East Asian patients have a higher prevalence of     platelet reactivity during DAPT, but an ischaemic event rate following PCI or ACS is similar     or even lower than white patients. Therefore, the antiplatelet treatment strategy that is     most appropriate for East Asian patients is increasingly urgent. Therefore, we performed the     current study to observe the different effects of low-dose ticagrelor (45 mg twice daily),     conventional-dose ticagrelor (90 mg twice daily) and clopidogrel (75mg once daily) on high     platelet reactivity (HPR) and IPA, and investigated the safety and efficacy of low-dose     ticagrelor further in Chinese patients with non-ST-elevation ACS (NSTE-ACS).   "
66460|NCT02415790|"     This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics     (PK) of single oral ascending doses of E2027, will be administered to healthy adult     participants to determine the maximum tolerated dose (MTD). Thereafter, the pharmacodynamic     (PD) effects of single doses of E2027 on elevation of cerebrospinal fluid (CSF) cyclic     guanidine monophosphate (cGMP) in healthy adult participants will be evaluated across a broad     dose range, to establish the PK/PD relationship.   "
66461|NCT02415777|"     A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy     and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction   "
66462|NCT02415764|"     Our team will develop a prototype game (OnTrack>The Game) in which users play the role of a     person who has experienced First Episode Psychosis and move through animated role-playing     scenarios, learning practical tips for engaging in care, playing mini-games to develop self-     advocacy skills, and seeing stories of hope and recovery (brief video vignettes). The game is     designed in an engaging comic book style in which the player is presented with realistic     situations designed to promote engagement and the development of trusting relationships.      Following development of the prototype, the investigators will conduct a pilot study to     develop preliminary data to determine feasibility of a large-scale Phase 2 effectiveness     study. This pilot study aims to demonstrate proof of concept for OnTrack>The Game. The     investigators will recruit a sample of patients/consumers (n=25) from OnTrackNY sites that     offer services for those experiencing their first psychotic episode. Quantitative data will     be collected through baseline and follow up surveys that utilize instruments to measure     knowledge and attitudes about recovery, perceptions of stigma, feelings of empowerment and     sense of hopefulness. The investigators will also conduct semi-structured interviews with a     subset of participants to explore engagement in treatment and attitudes toward the game.   "
66463|NCT02415751|"     This study is assessing the effects of a new heart failure self-care education program in the     Nebraska Heart Institute Heart Improvement Clinic. The new education program will consist of     an initial intensive self-care education session with the Principal Investigator or her nurse     practitioner. Topics to be discussed include medications, sodium and fluid consumption,     alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. As     recommended in the ACCF/AHA guidelines, this education will be repeated on an annual basis as     studies have shown that the impact of HF education is not always durable and must be a     continual process. This study will assess the impact of this review on their medication     knowledge, disease state knowledge, quality of life, disease state progression and clinical     outcomes such as ejection fraction and number of hospitalizations.   "
66487|NCT02415439|"     The purpose of this study is to examine the safety, tolerability, and PK of various     increasing single and multiple doses of VBP15 in healthy adult subjects.   "
72980|NCT02330523|"     To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked     collagen membrane with xenograft + non-cross-linked collagen membrane for posterior     extraction socket ridge preservation.   "
66464|NCT02415738|"     Hypoxemia may be refractory to protective ventilation during the acute respiratory distress     syndrome (ARDS), justifying the use of other therapies that improved oxygenation and     decreased mortality, including prone position (PP).      During ARDS, the majority of patients are responders to PP with increased PaO2 due to     homogenization of the ventilation-perfusion ratio. Despite changes in intra-thoracic and     intra-abdominal pressure, hemodynamic parameters are not changed.      Besides the fact that the PP improves systemic oxygenation is it the same on cerebral     oxygenation? No study has investigated the cerebral oxygenation during PP in patients with     ARDS. The cerebral oxygenation may be altered due to the position of the patient and high     levels of positive end-expiratory pressure. This decrease oxygenation may be responsible for     cognitive impairment when patients awake.      NIRS (Near Infrared Spectroscopy) is a noninvasive tool, capable of delivering information on     cerebral oxidative metabolism and its hemodynamic status. It can be used routinely for the     management of resuscitation in Intensive Care Unit (ICU) patients. This study is to     investigate cerebral oxygenation during prone position in the investigators' patients of ICU.   "
66465|NCT02415725|"     Many clinical situations in oncologic surgery imply the need to dissect more or less     extensively lymph node stations which are in direct relation with the lymphatic drainage of     the anatomical region affected by cancer.      The dissected lymph nodes drain generally several regions, and their dissection reduces then     the drainage capacity of all these regions, increasing the risk for the patient to develop a     secondary lymphedema, shorter or longer after surgery.      Efficient treatments exist, but are difficult to implement and to continue for a long     time.The later the treatment of the lymphedema begins, the heavier it is, both on the medical     and socio-economic level.      The lymphofluoroscopy, shows that some oncologic patients, operated and free of apparent     secondary lymphedema, present abnormalities of the lymphatic network.      The present study aims to confirm that it is now possible to detect secondary lymphedema at a     subclinical stage.   "
66466|NCT02415712|"     The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous     infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical     practice.   "
67492|NCT02402283|"     The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400     mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg     metronidazole per film coated tablet)/Zentiva.   "
66467|NCT02415699|"     Stage III colorectal cancer constitutes more than half of the colorectal patients, and the     prognosis does not improve much recently although varies of adjuvant drugs have been tried.     DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in     stage III colorectal cancer patients stains unclear. The investigators study will focus on     the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment     of stage III colorectal cancer, compared with chemotherapy alone.   "
66468|NCT02415686|"     SUMMARY      Rationale:      People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden     Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium     channel mutation (SCN1A) not only alters cortical excitability but also increases the     propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced     arrhythmias in human DS subjects.      Objective:      To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of     cardiac arrhythmias between DS subjects and subjects with other types of epilepsy.      Study design:      Observational study.      Study population:      Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥     1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of     self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the     EEG databases of the participating centres. Only those controls with two or more recorded     seizures will be matched to the cases.      Intervention:      Main study parameters/endpoints:      Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising     discomfort. If this nevertheless may occur, the study can be terminated. This study provides     specific tools to investigate the seizure-related heart rate response. Subjects may thus     benefit from participation by identification of otherwise unknown arrhythmias. The rationale     of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of     sudden death) specifically applies to DS, a rare epileptic syndrome including minors and     incapacitated persons. The investigators believe that the lack of risks, the potential     diagnostic benefit, the minimal intervention with novel and wearable sensors and the     possibility to terminate the study in case of discomfort, justifies the study in this patient     group.   "
66469|NCT02415673|"     The aim of the present study was to compare the effectiveness of two alignment sequences with     thermal activated archwires with different Af temperatures applied for the correction of     mandibular anterior crowding   "
66470|NCT02415660|"     This study will assess the short term response of thoracic spinal manipulation with or     without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck     pain.   "
66471|NCT02415647|"     The purpose of this research is to study new ways of classifying mental disorders in children     based on observable behavior and genetics to ultimately diagnose these disorders better.   "
66472|NCT02415634|"     The complexity of critical illness can result in both physical and psychological consequences     for survivors, which can extend past the intensive unit care stay and after hospital     discharge. A need for information and empowerment in the recovery process are highlighted for     developing treatment strategies. It is suggested that there is a relationship between     physical problems and psychological symptoms, but this has not been researched. This pilot     study aims to test the effectiveness of a physiotherapy directed Rehabilitation after     Critical illness Assisted discharge Pack (RECAP) on the physical and psychological function     of patients recovering from critical illness in the first three weeks post discharge from ICU     to the general ward area. The study will rely on a randomized controlled clinical trial     design, with patients assigned to either a usual care control group vs. the treatment     group. It is expected that engaging patients in their rehabilitation plan will focus     physiotherapy treatment and improve physical recovery. It is hypothesized that the RECAP will     reassure, support and empower patients to directly affect their psychological recovery in the     first three weeks after critical illness.   "
66473|NCT02415621|"     Abiraterone is approved in the United States by the U.S. Food and Drug Administration (FDA)     to treat metastatic prostate cancer at 1000 mg daily.      The purpose of this study is to find out if an on and off schedule of taking abiraterone     would prolong the participant's cancer's response to this drug and maintain their     functionality to perform their daily activities.   "
69861|NCT02371382|"     The purpose of this multicentre, prospective study is:        -  Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3          years, 5 years, 7 and 10 years.        -  Report Safety and Survivorship up to 10 years F/up.   "
66474|NCT02415608|"     This phase II trial studies ibrutinib to see how well it works in treating patients with     systemic (affecting the entire body) mastocytosis that has spread to other parts of the body     and usually cannot be cured or controlled with treatment (advanced). Systemic mastocytosis is     a disease in which too many mast cells (a type of immune system cell) are found throughout     the body. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red     face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood     pressure, and shock. Ibrutinib may stop the growth of mast cells by blocking some of the     enzymes needed for cell growth.   "
66475|NCT02415595|"     The purpose of this study is to find at least one dose of BMS-955176 that will be safe,     effective and tolerable for HIV-1 infected treatment naive adults.   "
66476|NCT02415582|"     The purpose of this study is to compare the effects of two exercise protocols on     post-exercise blood pressure versus a control group in elderly hypertensive men. Participants     are allocated to all groups: control group and two experimental exercise protocols, in a     random order. In the control group, participants remain resting sitting, and, in the exercise     protocols, participants practice exercise bouts of aerobic exercise or a combination of     resistance and aerobic exercises. In order to standardize baseline conditions, before the     sessions subjects remain sitting quietly for 20 minutes. After each exercise protocol,     participants have 60 minutes for recovery and, simultaneously, they have BP measured every 5     minutes. After the exercise sessions or control, an equipment for 24 hours ambulatory BP     monitoring is installed in every participant.   "
66477|NCT02415569|"     The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful     to improve bowel cleansing quality before colonoscopy.   "
66478|NCT02415556|"     The main purpose of this study is to find the long-term effects of daily administration of 40     IU of intranasal insulin (INI) as compared to placebo (sterile saline) on cognition and     memory in people with type 2 diabetes mellitus (DM), and non-diabetic controls over 24 weeks     with a follow-up period for 24 weeks. Four groups will be tested: DM group treated with INI;     DM group treated with placebo; control group treated with INI and the control group treated     with placebo. The INI or placebo will be delivered into the nose. The investigators are     interested to see whether INI can improve memory and cognition and blood flow in the brain in     the type 2 DM group as compared to placebo and to the non-diabetic group over a long-term     period.   "
67621|NCT02400606|"     The aim of the study was to explore the effect of actively constructing Virtual patient (VP)     cases compared with solving VP cases using 'Web-SP', Stockholm University, Stockholm, Sweden     on knowledge gains and skills transfer in a group of pre-clerkship medical students.   "
66479|NCT02415543|"     This study aim to compare the efficacy and safety of Single incisional Laparoscopic Total     Extraperitoneal(SIL-TEP) Inguinal Hernia Repair and traditional Laparoscopic Total     Extraperitoneal(TEP) Inguinal Hernia Repair in day surgery. This study also aim to improve     the surgical-related technical details and the device design.      In addition, this study also evaluate the operability of SIL-TEP in term of a day surgery     item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the     SIL-TEP technology in the investigators country.   "
66480|NCT02415530|"     This is randomized controlled trial investigating the effect of early intervention in very     low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than     control group of VLBW infants, study population includes term infants to compare     neurodevelopmental outcome.   "
66481|NCT02415517|"     The daily routine in clinical settings often showed cognitive impairments in patients with     congestive heart failure, particularly in terms of executive functions, episodic memory,     perceptual speed and attention. It is assumed that cognitive impairments in patients with     congestive heart failure may lead to deficits in medication-adherence and self-care     abilities, resulting in increased healthcare costs. Recent studies reported performance     improvements after cognitive training that transferred to new, untrained tasks and abilities     in healthy subjects across a wide range of ages. This study investigates the effects of     cognitive training in patients with congestive heart failure.   "
66482|NCT02415504|"     This pilot study examines the impact of an enhanced care transition process vs. usual care     for persons with dementia admitted to a transitional unit (hospital or LTC) for management of     behavioural and psychological symptoms of dementia (BPSD) with a planned discharge to long     term care (LTC) facilities or other hospital units. Deficiencies in discharge processes can     contribute to poor outcomes (e.g., readmissions), and there is a dearth of research on how to     improve care transitions for persons with BPSD. The investigators aim to improve the care     transition process for persons with dementia and BPSD utilizing an enhanced care transition     process that will contain up to 6 elements: integrated behavioural care plans, videos,     patient specific briefcase containing activities to reduce BPSD, in-person care transition     meeting, in-person care demonstration (when possible), and follow up visits with a transition     team. The ability to determine the effect of enhanced care transitions on the clinical course     of patients with planned discharge to LTC or hospital may allow for improved outcomes and an     overall increased efficiency of post discharge care.   "
66483|NCT02415491|"     Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the     cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of     the great arteries.   "
66484|NCT02415478|"     For patients with emphysema, lung volume reduction by insertion of endobronchial valves could     be an expedient approach to improve the diaphragm function and the strength of breathing     muscles. Therefore in the present study investigators intend to examine, whether the lung     volume reduction by valves might improve the physical capacity and the quality of life.   "
66485|NCT02415465|"     Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for     total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.      Hypothesis: CACB will provide better mobility than CSE post operatively.   "
66486|NCT02415452|"     This study is to investigate the relationship between staging of retinal artery lesions and     the prognosis of acute coronary syndrome (ACS) in a Chinese population. All the patients were     divided into four groups according retinal artery lesions.The endpoints were main adverse     cardiovascular and cerebrovascular events (MACCE), including all-cause death, myocardial     infarction (MI), and stroke after 3 to 6 years of follow-up.   "
66488|NCT02415426|"     The participants of this study have been diagnosed with mild to moderate depression with no     evidence of suicidal actions prior to recruitment. All recruited subjects receive standard     therapy and participate in a metacognitive training program (D-MKT) independently of study     participation. Diagnostic and therapeutical interventions are not part of this study. As part     of this study, the change of cognitive and psychosocial achievement/behavior in patients with     mild to moderate depression after taking part in the training program is being investigated.     The training program seeks to enable group members to recognize and correct the often     automatic and unconscious thought patterns that accompany depression, in part by viewing this     depressive thought process at a distance (i.e., depersonalizing). In addition, dysfunctional     assumptions about one's thought processes, as well as dysfunctional coping-strategies (i.e.,     thought suppression, rumination as problem-solving) are targeted (Lena Jelinek & Steffen     Moritz, http://clinical-neuropsychology.de/metacognitive_training_for_depression.html).     Within this study the cognitive and psychosocial behaviour changes are being investigated by     neuropsychological assessment as well as questionnaires.   "
66489|NCT02415413|"     Patients included in the study will receive induction treatment during 6 months, followed by     receive high-dose therapy followed by peripheral blood stem cell transplantation.      Approximately 3 months after peripheral blood stem cell transplantation patients will receive     consolidation treatment during 2 months.      Subsequently patients will start maintenance treatment during 24 months. Therefore, the total     duration of the treatment will be approximately 36 months.   "
66490|NCT02415400|"     The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist     given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial     fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in     the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors     (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a     comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K     antagonist, such as warfarin, with or without aspirin.   "
66504|NCT02415218|"     The study purpose is to evaluate the efficacy and safety of cultivated oral mucosal     epithelial sheet transplantation as a novel therapy for limbal stem cell deficiency, for     which no effective approaches has thus far been available, for the purpose of establishing     this therapy as an effective strategy for this disease with an aim of improving visual acuity     and corneal transparency.   "
66491|NCT02415387|"     This randomized clinical trial uses a typhoid vaccine to cause an immune response in patients     with stage I-IIIA breast cancer who received chemotherapy and studies whether patients'     fitness levels affect how well their bodies handle a challenge to their immune system. A     vaccine is a substance or group of substances meant to cause the immune system to respond to     a tumor or to microorganisms such as bacteria or viruses. Immune responses may cause excess     inflammation in the body and behavioral changes, such as depression, fatigue, pain, and     problems with thinking and reasoning. Studying immune responses in patients with breast     cancer who have undergone chemotherapy may help doctors learn whether physical fitness can     protect the body from effects of immune system stress and whether it may be able to reduce     health problems in patients with breast cancer who have undergone chemotherapy.   "
66492|NCT02415374|"     The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in     oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of     AVAs and their potential metabolites after ingestion. The blood and urine concentrations will     be quantified at several different time points after the oat flour cookies are consumed to     characterize the concentration-time profile.   "
66493|NCT02415361|"     In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents     of infants with CLP need information and support, especially with feeding immediately after     birth. These needs are often not met. The purpose of this study is to investigate the effect     of systematic follow ups of parents with infants with CLP performed by a special trained     nurse. Parental information needs, parental coping and stress and infant growth and feeding     will be explored and compared to a control group receiving standard care. 26 parents (mothers     and fathers) or more shall be included in each group according to specific criteria. The     control should be examined first. Both groups will answer questionnaires 3 times during the     child's first year.   "
66494|NCT02415348|"     This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive,     ultrasound-based device used to estimate fibrosis in patients with chronic liver disease,     interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators.     Recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation     at a teaching-hospital pacemaker clinic.   "
66495|NCT02415335|"     For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the     incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of     8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been     established. The investigators wish to see if preoperative administration of 8 mg     dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis     will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see     if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative     fatigue, duration of time until resumption of work and resumption of normal daily activities,     and enhanced the quality of recovery.   "
66496|NCT02415322|"     The aim of this cohort study is to observe the prevalence, incidence, relapse, and remission     rates of online and/or smartphone game addiction among elementary and secondary school     students in Korea. In addition the investigators are going to identify risk and protective     factors, to determine whether online and/or smart phone game addiction is a primary or     secondary problem, and to identify outcomes for individuals who become or stop being online     and smart phone game addiction.   "
66511|NCT02415127|"     The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study     is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of     Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of     ACTIMMUNE® in FA patients.   "
67400|NCT02403518|"     This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of     chronic back and leg pain. Patients who have been diagnosed with failed back surgery syndrome     (FBSS) will receive a stimulator device for treatment of their pain.   "
66497|NCT02415309|"     Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated chronic     low back pain. This interventional pain procedure often occurs in the fluoroscopy suite.     During this procedure, a physician inserts the needles to deliver local anesthetics such as     lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint. Many patients     experience anxiety before and during the lumbar medial branch block procedure and require     intravenous midazolam or fentanyl for sedation. Intravenous or conscious sedation requires     one-to-one nursing care, monitoring, and recovery. In order to minimize the costs and time     requirements of intravenous sedation, a suitable oral medication which is readily available     and non-controlled would be ideal. Several randomized double-blinded, controlled trials have     investigated the anxiolytic effects of melatonin before a surgery; however no studies to date     have studied the anxiolytic effects of melatonin before less invasive interventional pain     procedures. This study is designed to evaluate the efficacy of melatonin for reducing anxiety     in patients undergoing a lumbar medial branch block procedure.      The study is a randomized, double-blinded, placebo-controlled trial with 40 patients in each     group: 2 mg melatonin, 10 mg melatonin and placebo. The primary outcome is anxiety reduction     in patients before undergoing the procedure. The primary outcome is measured by visual     numerical rating scale for anxiety and the Amsterdam Preoperative Anxiety and Information     Scale. Based on the results of previous studies, the investigators hypothesize that melatonin     may reduce anxiety in patients undergoing the procedure and be a suitable alternative to     intravenous sedation in the pain clinic for patients undergoing lumbar medial branch blocks.   "
66498|NCT02415296|"     The Internet medium is particularly vector for gambling problems. Since the opening of the     online gambling sector in France, no screening for excessive gambling behaviours is provided     for by the law, although it is known that preventive actions are more effective if they are     implemented early in the gambler's career.      The investigators propose to develop a model for screening excessive gambling practices based     on the gambling behaviours observed on French gambling websites, coupled to a clinical     validation. The objective is to lead to early preventive measures directed towards the more     vulnerable gamblers and adapted for each type of gambling.      This study will therefore contribute to setting up an innovative measure of prevention, to     inform and protect gamblers as early as possible.   "
66499|NCT02415283|"     The Exalenz clinical investigation is a multicenter, non-randomized, study of the     ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to     evaluate the capability of the OBT to differentiate between presence and absence of HCC     determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.   "
66500|NCT02415270|"     The overall objectives of this clinical study are to determine in smokers the short term     effects of switching to tobacco products that deliver low levels of nicotine or reactive     oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke     exposure and oxidative stress.   "
66506|NCT02415192|"     Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination     drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium     channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus,     there's no enough safety data and efficacy data defined from the clinical study.      Also, many combination drugs of valsartaa and amlodipine are widely used in the market.      LGLS will compare the safety(adverse events especially the lower leg edema) and efficacy     (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this     study.   "
66507|NCT02415179|"     The purpose of this study is to investigate the effectiveness of inhaled     mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in     treatment of asthma.   "
66508|NCT02415166|"     The aim of this project is to evaluate the efficacy of the influenza vaccine in individuals     with major depressive disorder (MDD) as well as to elucidate the nature of the immunological     abnormalities in MDD using a quasi-experimental design. Specifically, the investigators plan     to induce transient, mild inflammation in medically-healthy study participants using the     influenza vaccine. Initially the investigators will conduct a pilot project with up to 20     individuals in order to evaluate the time-point at which the peak inflammatory response to     the vaccine occurs. Subjects will receive the seasonal influenza vaccine and provide blood     samples 4 hours, 2 days, and 30 days post vaccination. Subsequent to the pilot study, both     depressed and psychiatrically-healthy participants will be randomized in a parallel group,     double-blind design so that they receive either influenza vaccine (seasonal vaccine) or     saline (i.m). At baseline, subjects will provide a blood sample, complete a number of rating     scales to measure mood and fatigue, and may complete approximately one hour of MRI scanning     with or without simultaneous EEG recording. Two-days post vaccination, they will provide a     second blood sample, complete more clinical ratings and may complete another identical MRI     session with or without simultaneous EEG. Four weeks later, participants will be asked to     return to provide a third blood sample and complete additional clinical ratings. The blood     samples will be used to measure both innate and adaptive immune function and may be used to     correlate the vaccine-induced immunological changes to neurophysiological changes in the     brain measured by MRI and/or EEG.   "
66509|NCT02415153|"     This phase I trial studies the side effects and best dose of pomalidomide in treating younger     patients with tumors of the brain or spine (central nervous system) that have come back or     are continuing to grow. Pomalidomide may interfere with the ability of tumor cells to grow     and spread and may also stimulate the immune system to kill tumor cells.   "
66510|NCT02415140|"     Depression adversely affects quality of life in COPD patients, associated with higher rate of     exacerbations, admissions and mortality. However, local prevalence rate of depression in     geriatric COPD patients remains unknown.      Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear     which domain of BODE correlates best with depression. Furthermore, with multiple confounding     factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for     depression among COPD patients.      The objective of this study is i.) to study the local prevalence rate of depression in     geriatric COPD patients, ii.) to identify risk factors for depression especially looking at     the any independent relationship between frequent exacerbations, various domains of BODE     index and depression.   "
73043|NCT02329691|"     The main objective is to explore and evaluate the effect of a change in the WHO checklist on     the safety climate in the operating room at a University Hospital in Gothenburg.   "
66512|NCT02415114|"     The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy     subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of     the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10     when administered Omega Q Plus® Resveratrol for 28 days. The safety objectives will include     assessment of safety evaluations as determined by:        -  laboratory tests - CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT,          and bilirubin        -  vital signs - heart rate and blood pressure        -  adverse events   "
66513|NCT02415101|"     This study compares outcomes with regard to the timing of resective surgery after neoadjuvant     chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients are randomised     to surgery either conventional 4-6 or 10-12 weeks after termination of CRT. The study     hypothesis is that a longer delay improves histological response and decreases the risk of     postoperative morbidity and mortality.   "
66514|NCT02415088|"     This is a randomised, observer-blinded trial to compare selective shoulder block with     interscalene block. Both blocks will be placed using an ultra-sound guided technique.      Primary outcome measures will be postoperative pain scores and use of rescue opioids.     Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the     arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric     rating scale and overall satisfaction with pain therapy as measured by the International Pain     Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied).      Primary and secondary outcome measures will be assessed during the first 24hours after     surgery (assessment in the postanesthetic care unit (PACU) directly after admission and     before discharge and in the surgical ward at 4, 8 and 24 hours after surgery).      Overall satisfaction with pain therapy will be assessed 48hours after surgery.      An interscalene block is a block of the plexus brachialis in the interscelene triangle (by     injecting a local anesthetic around the nerve plexus).      A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting     a local anesthetic around these nerves).   "
66515|NCT02415075|"     The purpose of the study is to determine which factors on a personal, social and contextual     level will help rehabilitation patients on returning to or continuing to work as well as to     stay employable.   "
66516|NCT02415062|"     The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg)     in Parkinson's disease with dementia compared to standard dose donepezil.   "
66785|NCT02411565|"     The main purpose of this Pilot Study is to test the safety, tolerability and quality of life     in women who take Fermented Wheat Germ Extract (FWGE), to determine if an active form of FWGE     can be detected in the blood, and determine whether short-term therapy with FWGE has any     effect on the tumor marker, cancer antigen 125 (CA-125).   "
66517|NCT02415049|"     There are several choices to consider when determining the timing of initiation of enteral     feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as     the infant awakens from anesthesia. Some authors have suggested a period of withholding     feedings for several hours postoperatively, while others have recommended a significantly     longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises     over whether a physician chooses a standardized, incremental feeding regimen versus an ad     libitum feeding schedule which allows the infant to decide when and how much to eat. Neither     has been studied effectively in a randomized controlled setting. A recent review of the     literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be     the best postoperative regimen. This however, has not been studied in a randomized,     controlled trial.   "
66518|NCT02415036|"     This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and     safety of Melphalan/HDS in patients with unresectable Hepatocellular Carcinoma (HCC) or Intra     Hepatic Cholangiocarcinoma (ICC) confined to the liver.   "
66519|NCT02415023|"     An open-label, dose escalation and maximum tolerated dose (MTD) and/or recommended phase II     dose (RPTD) study of fruquintinib combined with paclitaxel in patients with advanced gastric     cancer who did not respond to first-line standard chemotherapy.   "
66520|NCT02415010|"     The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and     safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil     embolization of ruptured or non-ruptured intracranial aneurysms.   "
66521|NCT02414997|"     The purpose of this study is to determine the effect of remote ischemic preconditioning     (RIPC) on blood pressure and its vascular protection effect among Chinese young healthy     adults and primary hypertensive patients stage I.   "
66522|NCT02414984|"     The purpose of this study is to describe adherence to golimumab in Colombian participants     with rheumatoid arthritis (RA) experiencing adequate treatment response, in a real-world     clinical settings.   "
66523|NCT02414971|"     Project Study: Pilot Human Study Specific Aims: 1. describe levels of mitochondrial     respiratory enzymes 2. examine relationships between levels of mitochondrial enzymes,     fatigue, and health-related quality of life; and 3. compare levels of mitochondrial enzymes     in men with a clinically-significant change in fatigue from those with no change in fatigue.      Significance of Study: Cancer related fatigue is a common side effect of cancer. Cancer     related fatigue is poorly understood. Many different biological mechanisms have been     theorized, including mitochondrial dysfunction. Self-reported descriptions of reduced energy     and muscle weakness lend support for a possible relationship of cancer related fatigue to     mitochondrial dysfunction.      Main Research Variables: Mitochondrial Enzymes, Cancer related fatigue, and health related     quality of life Design: Descriptive, longitudinal study Sample/Setting: Men with     non-metastatic prostate-cancer who are scheduled to receive radiation therapy Methods:     Questionnaires, mouth swabs and blood will be collected at four study visits: prior to     treatment, midpoint of treatment, completion of treatment and within 90 days of finishing     treatment. Four mouth swabs will be collected per participant at each study visit.      Implications for Practice: Understanding the role of mitochondrial enzymes in cancer related     fatigue has major clinical implications in the development of targeted interventions and in     providing specific knowledge for patients and their families to make informed treatment     decisions.   "
69879|NCT02371148|"     This is a prospective, multicenter phase II trial designed to determine efficacy and safety     of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory     Waldenstrom's Macroglobulinemia.   "
66525|NCT02414945|"     This is a phase I and II clinical study for patients with malignant pleural mesothelioma (a     type of cancer affecting the lining of the lung). Patients will receive an infusion (given by     vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood     cells that recognizes tumor cells and enter them which causes the tumor cells to break down.      Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and     fludarabine to prepare the body to receive the TILs. After cell infusion, patients will     receive low-dose interleukin-2 therapy. This study will see how safe and useful this regimen     is in treating malignant pleural mesothelioma.   "
66526|NCT02414932|"     Depression affects up to 20% of people in their lifetime and can be a severe debilitating     illness. Indeed, the World Health Organisation has estimated that depression will soon be the     second leading contributor to the burden of disease worldwide. One of the big problems for     patients and doctors is that currently available antidepressant drugs and psychotherapies do     not work for 30% of people. However, about 60% of such treatment-resistant patients will     recover fully with electroconvulsive therapy (ECT). Even though it was developed over 75     years ago, ECT continues to be the most powerful treatment for severe, often     life-threatening, depression. Despite that, we have recently reported that severe depression     symptoms return (called a relapse) in nearly 40% of such responders within six months of     completing a course of ECT. Actually, such high relapse rates are seen for all patients with     treatment-resistant depression, irrespective of what treatment they have received. There is     thus an urgent need for better treatments to prevent relapse and one such possibility is an     old drug called ketamine. Ketamine blocks the activity of glutamate, one of the major     chemical messenger systems in the brain. Because of this effect it is sometimes used as an     anaesthetic but it can also make you feel a bit high and so is sometimes abused as a     recreational drug. Fortunately, in small doses it is quite safe. Recently, it has been found     that ketamine has a remarkably rapid, but brief, antidepressant effect, including reducing     suicidal thoughts. We wish to evaluate ketamine as a way to reduce relapse rates in people     who have just been treated successfully with ECT for severe depression. Developing such a new     treatment, and understanding how it works, would be of tremendous benefit to persons with     severe depression, their families, and the wider society.   "
66527|NCT02414919|"     To assess the proportion of women who use HERC for ≥2 years of duration   "
66528|NCT02414906|"     Acute kidney injury (AKI) is a frequent complication in critically ill patients admitted to     intensive care unit (ICU) and it is associated with increased morbimortality.      There is evidence that perioperative hemodynamic optimization decreases the incidence of AKI     in the post operative phase in high-risk patients. We aimed to evaluate if the use of a     goal-directed therapy to increase oxygen delivery in the early phase of acute kidney injury     can decrease the prevalence of patients with acute renal failure.   "
66786|NCT02411552|"     This initiative is a prospective study evaluating the effects of implementing physical     activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.   "
66529|NCT02414893|"     The mechanisms that regulate appetite in the morbidly obese are multifactorial and not     well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an     important role in the central regulation of appetite and hunger. Postprandial ghrelin and     cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an     effect on satiety sensation.      On the other hand, bariatric surgery is supposed to affect hunger and satiety in and also     promotes changes in gastric emptying which are not clearly defined.      Aim: To better understand the physiologic mechanisms involved in the regulation of hunger and     satiety in morbidly obese individuals, especially those related with gallbladder and gastric     emptying, as well as those related with the response of the gastrointestinal hormones     ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric surgery (sleeve     gastrectomy). Methodology: Three groups of individuals will be studied and compared: group A)     non obese healthy subjects, group B) morbidly obese subjects and group C) morbidly obese     subjects who had had a previous sleeve gastrectomy. In all subjects a standard meal test     after a fasting night will be administered and appetite, satiety and hormonal response     (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed, as well as     postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol     absorption technique.   "
66530|NCT02414880|"     Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that     substantially affects drug pharmacokinetics. Rocuronium onset time is longer and recovery     time from it is prolonged in cirrhotic patients than in those with normal liver function.      This randomized controlled study is designed to compare the pharmacodynamic profiles of     sugammadex and neostigmine when used for the antagonism of moderate degree of     rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and     in patients with preoperative normal liver functions undergoing liver resection.   "
66531|NCT02414867|"     The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old     children.   "
66532|NCT02414854|"     Primary Objective:      To evaluate the efficacy of dupilumab (SAR231893 [REGN668]) in patients with persistent     asthma.      Secondary Objectives:      To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in     improving patient-reported outcomes including health-related quality of life.      To evaluate dupilumab systemic exposure and incidence of antidrug antibodies.   "
66533|NCT02414841|"     This research study is designed to assess the safety and effectiveness of an experimental     drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive     hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new     access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been     shown in previous research studies to help keep vessels patent when applied to the outside     surface of the blood vessels (arteries and veins) in patients who undergo surgery to create     an arteriovenous fistula (AVF). The purpose of this study is to determine whether     vonapanitase when applied to a limited segment of your blood vessel (about 2 inches)     immediately after surgery is safe and improves the patency of your AVF.   "
66534|NCT02414828|"     This was a double-blind, randomized, placebo-controlled dose-escalation study in adults     recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups.     Enrollment into a dose group was sequential. Enrollees were stratified based on time from the     start of TB treatment. The on-TB-treatment stratum started TB treatment between 1 and 4     months (30 to 120 calendar days) prior to Study Day 0. The post-TB-treatment stratum     started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects     were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects     were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects     were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or     placebo.   "
66535|NCT02414815|"     Atrial fibrillation(AF) is the most common sustained arrhythmia in humans. The loss of     rate-dependent action potential duration(APD) adaptation is one of the characteristics of     atrial fibrillation, but detailed understanding of mechanism is limited. Thus, we propose to     utilize the monophasic action potential recording data from human patients in three groups,     control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method     to quantify the extent of electrical remodeling of ionic channel parameters using a     mathematical model of atrial cell. Our approach will be useful in developing drug targets for     ion channels in atrial fibrillation patients.   "
66536|NCT02414802|"     The purpose of this study is to determine whether the novel aspiration thrombectomy device     combined with catheter-directed thrombolysis is effective in the treatment of acute     iliofemoral deep venous thrombosis (IF-DVT).   "
66537|NCT02414789|"     Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass     spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with     the early skin manifestation (erythema migrans).      This new proteomic method will be compared to the two existing method: culture of Borrelia     and PCR detection of Borrelia (DNA detection of the bacteria).   "
66538|NCT02414776|"     To determine the safety and tolerability of orally administered hydroxychloroquine with     hormonal therapy.      To assess the response rate of hydroxychloroquine in combination with hormonal therapy.   "
66539|NCT02414763|"     The current study proposes to study the feasibility and acceptability of a brief psychosocial     intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor     or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will     involve training of care providers affiliated with Vanderbilt University Medical Center to     deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3,     and 12-month assessments on outcomes of interest, including readiness to change problematic     behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming     behavior, and reasons for living.   "
66540|NCT02414750|"     This is a single arm explorative phase II clinical trial in 90 subjects with advanced stage     melanoma harbouring a BRAFV600 mutation. PET imaging and molecular diagnostics are combined     in order to monitor response to treatment with vemurafenib plus cobimetinib, examine     development of resistance and correlate changes in metabolic/proliferative activity with     extend of target inhibition.   "
66541|NCT02414737|"     We would like to propose that it may be possible to use a solitary dose of Elonva     (corifollitrophin alpha) as the sole gonadotrophin (FSH) stimulant for the vast majority of     women undergoing IVF, assuming that it is possible that coasting (withholding short acting     rFSH) from day 8 of the stimulation until trigger/ oocyte retrieval will still result in a     significant number of mature oocytes being produced and an acceptable pregnancy rate.   "
66542|NCT02414724|"     This phase I trial studies the side effects and best dose of ribociclib and gemcitabine     hydrochloride in treating patients with solid tumors or lymphoma that have spread to other     places in the body and usually cannot be cured or controlled with treatment. Ribociclib may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving ribociclib together with gemcitabine hydrochloride may     work better in treating patients with solid tumors or lymphoma.   "
66543|NCT02414711|"     Depression has emotional consequences, social and important business. Reaching at least 7.5%     of French aged 15 to 85 years. General Practitioners are the first professional consulted in     terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with     depression that General Practitioners are often alone to support and follow. But General     Practitioners are faced with diagnostic difficulties facing the diagnosis of depression,     because if the patient does not engage itself, no tool is validated in France to help them in     their diagnosis. However, standardized questionary exist that allow to overcome this     difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was     selected by a systematic review of literature and a RAND UCLA type of consensus procedure.     This HSCL25 scale is the most efficient for the diagnosis of depression in terms of     efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm its     validity in terms of the French translation and in terms of efficiency.   "
66544|NCT02414698|"     To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet     Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with     lumbar radiculopathy due to contained disc herniation with symptoms that persist following a     treatment course of conservative management including physical therapy and anti-inflammatory     medication.   "
66545|NCT02414685|"     TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor     markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until     progression, unacceptable toxicity, complete response or inability of the subject to comply     with study requirements.   "
66546|NCT02414672|"     The CareSTEPS intervention fills an important service gap by providing education, skills     training, and support to the caregivers of advanced lung cancer patients on active treatment.     The home-based delivery format will facilitate future dissemination and outreach. By     empowering families with the skills they need to provide care and meet the challenges of lung     cancer, this intervention holds great promise for improving caregiver quality of life (QOL),     patient QOL, and the quality of palliative and supportive care services offered to patients     with advanced cancer and their families.   "
66547|NCT02414659|"     Umbilical cord blood (UCB) collection and storage is a rapidly advancing field in hematology     due to UCB's use for treatment of many hematological diseases, including but not limited to,     Fanconi anemia, thalassemia, leukaemia and metabolic storage diseases. Primarily, there are     two ways for UCB harvesting, first in-utero collection and second ex-utero collection.     Depending on the amount of UCB collected, in-utero harvesting practice prolongs the operative     time of cesarean delivery and speculatively increases intraoperative blood loss. The aim of     this study is to determine UCB collection's effect on intraoperative bleeding in women     undergoing elective cesarean delivery.   "
66548|NCT02414646|"     This phase II trial studies how well trastuzumab emtansine works in treating older patients     with human epidermal growth factor receptor 2 (HER2)-positive stage I-III breast cancer. HER2     is a protein found on the surface of cancer cells that helps them to grow and spread.     Trastuzumab emtansine may kill cancer cells by binding to HER2-positive on the surface of the     tumor cells and blocking their ability grow and spread.   "
66549|NCT02414633|"     A special investigation (post marketing observational study (PMOS)/non-mandatory) of HUMIRA®     will be performed for correlation between baseline and follow-up by clinical observation 24     weeks (planned visit time; before the start of treatment, and at 4, 12, 16, and 24 weeks, 4     data collection points) in Japanese psoriatic arthritis patients who are engaged in paid     work.   "
66550|NCT02414620|"     The purpose of the research was to test the efficacy of the Dental Vibe Injection Comfort     System. The study was conducted by faculty to have students as subjects to see if there are     any differences in the comfort level of an ASA injection given on one side with topical     anesthesia and lidocaine 1:100,000 with epinephrine using a standard syringe, and the other     side uing the Dental Vibe, topical anesthesia and lidocaine 1:100,000 with epinephrine and a     standard syringe. The Dental Vibe emits strong pulsed vibration which is transmitted via a     silicone mouth piece to mucosal tissue. This in turn interferes with, blocks or reduces the     perception of pain from the injection for the patient. It is stated that this phenomenon is     achieved due to the gate theory of neuronal activity. There are also likely, distraction     and placebo effects that contribute to the devices' efficacy.   "
66551|NCT02414607|"     Elderberries (Sambuci fructus) have been shown in a number of studies to have significant     anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported     the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used     in natural medicine for hundreds of years. Studies examining factors that may decrease the     risk of Alzheimer's disease have revealed that drinking juices with similar properties to     elderberries is one of the most reliable way to decrease risk. As such the investigators wish     to determine the effects of elderberry juice on cognitive decline in a group of subjects at     high risk for Alzheimer's disease, those with mild cognitive impairment. Elderberry juice is     a commercially available nutritional supplement and easily available to this population.   "
66552|NCT02414594|"     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.   "
66555|NCT02414555|"     Background Intraoperative hypotension is a common problem that significantly contributes to     perioperative mortality and morbidity. At the moment the gold standard for perioperative     fluid management is the so called goal-directed therapy that features fluid resuscitation     followed if necessary catecholamines if needed for perioperative cardiocirculatory support.      Worldwide the so called physiological sodium chlorid (0.9% NaCl) solution is the most often     used infusate for perioperative fluid management. Despite its widespread use physiological     saline has its major disadvantages such as the increased incidence of metabolic acidosis.     Nevertheless catecholamines have their significant side effects as well (eg diminished renal     perfusion, increased cardiovascular morbidity) and they therefore should be used with     caution.      In a prior study by group members on patients undergoing renal transplantation receiving     either physiological saline or an acetate-buffered infusate showed a 50% decrease in     catecholamine necessity in the acetate-buffered infusate group. The investigators therefore     would like to evaluate the effects of the perioperative fluid choice on the necessity of     catecholamine use.      Aim        -  Evaluation of the perioperative fluid choice on the necessity of catecholamines for          cardiocirculatory support.        -  Description of the relationship between perioperative fluid choice and minimal blood          pressure as well as the time to catecholamine use and their dosage.      Methods The investigators plan a prospective randomized-controlled trial of all patients     undergoing major abdominal surgery at the Vienna General Hospital and Medical University of     Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based     treatment scheme.   "
66556|NCT02414542|"     Post-marketing clinical study,international, multi-centre, prospective, observational. The     investigation will be carried out in 2 sites in Europe for a maximum total number of 160     patients.The aim of this study is to assess clinical, radiographic and subjective outcomes     after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the     survivorship of the implant and identify possible risk factors that may lead to failure.   "
66557|NCT02414529|"     The purpose of this study is to see whether giving a Vitamin D supplement to vitamin D     deficient obese children and adolescents will decrease the risk of getting diabetes (Disease     in which the person has high blood sugar).      The number of vitamin D deficiency in U.S. children and teenagers has grown dramatically over     the past 30 years. There are some reports suggesting that vitamin D supplementation in adults     with pre diabetes (blood glucose higher than normal) and vitamin D treatment will prevent     diabetes.   "
66558|NCT02414516|"     This Phase 1a, single center, open-label, repeat dose study will evaluate the safety,     efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid     tumors.   "
66559|NCT02414503|"     Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate     lactation in breastfeeding women. The intranasal administration of OT has recently attracted     attention as a potential novel treatment in several psychiatric disorders in autism. However,     given the anatomy of the nasal cavity, the current design of nasal sprays would be expected     to provide an inadequate delivery of medication to the areas of the nasal cavity where direct     transport into the brain via the olfactory nerve could potentially occur. OptiNose has     developed an intranasal delivery device that provides improved reproducibility of nasal     delivery, improved deposition to the upper posterior regions of the nasal cavity where the     olfactory nerve innervates the nasal cavity.      The primary objective of this study is to identify any differences between a single dose of 8     international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with     the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be     measured in terms of performance on cognitive tests and physiological markers.   "
66560|NCT02414490|"     This is a prospective observational study of 30 adult CIDP patients who receive home IVIg     infusion services from AxelaCare Health Solutions, LLC. The decision to treat with IVIg will     be entirely at the discretion of the patient's treating physician.   "
66561|NCT02414477|"     The purpose of this study is to better understand how people break down a tobacco specific     cancer-causing toxin called N'-nitrosonornicotine (NNN) that is present in smokeless tobacco     and cigarettes. Some people are able to get rid of this chemical as a harmless agent better     than others. Through this research, the investigators hope to develop a better understanding     of how people process potentially harmful chemicals and identify tobacco users who are in     danger of developing cancer. Participants will complete questionnaires regarding their health     and smoking history. The investigators will take blood samples, saliva samples, cheek cells     and urine to measure exposure to toxins and harmful chemicals present in smokeless tobacco.     Participants will be given smokeless tobacco study product and be asked to use only it for     the entire time they are in the study. The study product contains deuterated NNN. Deuterated     NNN is just like the NNN found in commercially available smokeless tobacco products, but is     labeled with deuterium or heavy hydrogen atoms. Deuterium is non-toxic and safe. Using     smokeless tobacco containing deuterium allows us to follow NNN as it is broken down in the     body.   "
66562|NCT02414464|"     The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in     young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.   "
66563|NCT02414451|"     The purpose of this study is to explore the effects of propranolol on social interaction, and     secondarily on language, anxiety, adaptive behaviors, and global function in high functioning     adults and adolescents with autism in a double-blinded, placebo-controlled pilot trial.   "
66564|NCT02414438|"     The study uses a randomized controlled study design of pediatric neurologists and     developmental pediatricians and front-line (primary care) pediatricians to determine if use     of FirstStepDx PLUS and Next StepDx PLUS are associated with higher clinical quality, less     variability in clinical practice, and lower costs from decreased resource utilization. The     Clinical Performance and Value Vignettes (CPV) used in this study simulate a clinical     encounter for individuals with an atypical phenotype and clinical presentation indicative of     a possible genetic disorder. We will measure the difference in combined diagnostic and     treatment CPV® domain score post-intervention versus baseline comparing intervention and     control groups   "
66787|NCT02411539|"     The purpose of this study was to evaluate the safety, tolerability, and effect of an     experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected     with HIV who were receiving antiretroviral therapy (ART).   "
66565|NCT02414425|"     Fecal incontinence is a frequent pathology which concerns 10% of the general population and     severely alters patients quality of life. The cost of urinary and faecal incontinence has     been estimated to be $16 billions a year. Several treatments exist depending on the aetiology     of the faecal incontinence: medical treatments, biofeedback and sacral nerve stimulation.     Nevertheless, these treatments are not always effective (50-70% of success) and are not     without side effects, particularly the sacral nerve stimulation (pain, infection, electrode     displacement..).      The intravesical injections of botulinum toxin have been used for several years for the     treatment of urinary incontinence with overactive bladder. Several randomized trials have     demonstrated the efficacy of these injections in patients with neurological disorders and     overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the     detrusor muscle increase the compliance and the bladder capacity and delay the initial     appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the     urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor     uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve     afferents.      The botulinum toxin should play a role on motor afferents as well as on the sensory function     of efferent nerves.      The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency     episodes with improvement in quality of life, without any major side effects, in the patients     included in this study. Nevertheless, the benefit of toxin injections are known to be     temporary because of nerve re-growth. If we obtain similar results for fecal incontinence, it     would be possible to schedule one to two injections a year because of the limited     side-effects and invasiveness of the rectal injections.   "
66566|NCT02414412|"     This randomized, placebo-controlled, double-blind study evaluates the efficacy and     tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively healthy     adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a placebo     for 4 weeks.   "
66567|NCT02414399|"     Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity     and mortality following discharge from hospital. These children represent an accessible     high-risk population in which targeted interventions to prevent morbidity and mortality could     have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass     drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated     an almost 50% mortality benefit in children 1-9 years of age in treated communities. However,     mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance     within treated communities and is expensive. The targeted delivery of azithromycin to     children at hospital discharge may be a novel and practical intervention to maximize benefit     while minimizing risk of antibiotic resistance. This is a randomized, double-blind,     placebo-controlled trial to determine the efficacy of azithromycin provided at discharge,     compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59     months in Kenya. The study will also investigate potential mechanisms by which azithromycin     may reduce morbidity and mortality in this population and will assess the emergence of     antibiotic resistance among treated individuals and their primary caregivers. A     cost-effectiveness analysis of the intervention will also be conducted.   "
66575|NCT02414295|"     Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical     findings are nonspecific during childhood; thus, the diagnosis commonly is made during     adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism     and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.      Approximately one in 1,000 boys is born with an additional X chromosome—47,XXY, the karyotype     that causes Klinefelter syndrome. This karyotype is detected at or before birth in 10 percent     of affected boys, and it is found during adulthood in 25 percent of affected men. Almost all     men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for 3 percent of     male infertility.      Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10     percent).      Infertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count.     If sperm are present, cryopreservation is useful for future family planning with     intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued.     Although there have been multiple reports of successful fertilization by men with Klinefelter     syndrome.      Mesenchymal stem cell injection in testicular tubules and intra testicular artery using     surgical microscope.      The period for follow up last from three months to twelve months including semen analysis to     detect sperm and hormonal profile .   "
66568|NCT02414386|"     Several studies point at a potential relationship between vitamin D deficiency and worse     outcome in critically ill patients admitted to the intensive care unit. It is linked with the     lack of vitamin D pleiotropic effects in the state of hypovitaminosis D. The pleiotropism of     vitamin D is dependent on a specific feature of vitamin D receptor (VDR) namely polymorphism     and its universal existence in the human body. Vitamin D pleiotropism is linked with cancer     cells inhibition, a modulation of the immune system, an influence on cardiovascular system     and neuroprotection.      In 35-65% critically ill patients hospitalized in the intensive care unit the acute kidney     injury (AKI) is diagnosed. Acute kidney injury increases significantly the probability of     death. The standard therapy of a severe AKI in many intensive care units is the regional     citrate anticoagulation continuous renal replacement therapy by means of continuous     veno-venous hemodiafiltration (CVVHDF). The specificity of the regional citrate     anticoagulation by means of precise ionized calcium and citrate dosing evokes questions     regarding its influence on vitamin D and entire calcium-phosphate metabolism in the state of     a severe AKI treated with regional citrate anticoagulation continuous renal replacement     therapy.      The intention of that trial is to measure vitamin D plasma levels and other parameters     (parathormone, ionized and total calcium, magnesium, phosphate, albumin, globulin) linked     with calcium-phosphate metabolism in the human body. We would like to assess potential     relationships between the regional citrate anticoagulation continuous renal replacement     therapy and these parameters.   "
66569|NCT02414373|"     Acute urinary retention is one of the most common complications after surgery and anesthesia.     Micturition depends on coordinated actions between the detrusor muscle and the external     urethral sphincter. Under the influence of epidural analgesia, patients may not feel the     sensation of bladder filling, which can result in urinary retention and bladder     overdistension. Overfilling of the bladder can stretch and in some cases permanently damage     the detrusor muscle. Because epidural anesthesia can be performed at various levels of the     spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade).     Thoracic epidural analgesia with bupivacaine significantly inhibits the detrusor muscle     during voiding, resulting in clinically relevant post void residuals which required     monitoring or transurethral catheterisation. This bladder muscle inhibition is comparable to     a motor blockade. The epidural administration of ropivacaine during labour results in a     clinically relevant reduction of motor blocks.      The hypothesis is that thoracic epidural analgesia with the local anesthetics ropivacaine     leads to less significant changes in bladder function than bupivacaine as a control group, in     patients undergoing lumbotomy incision for renal surgery.   "
66570|NCT02414360|"     The purpose of this pilot study is to determine the feasibility of running a full-scale trial     that compares two formats of a shortened systematic review to a full-length systematic review     to be used in clinical decision-making.   "
66571|NCT02414347|"     This project will collect quantitative pilot data that will allow the characterization of     uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in     individuals with and without brain tau fibrils. The primary goal is to develop tau imaging     technique as an antecedent biomarker of cognitive decline. The investigators propose to     obtain preliminary data that will support the possibility of detecting cognitive decline in     its earliest stages, before the occurrence of dementia.   "
66584|NCT02414178|"     The purpose of this research study is to evaluate a new radioactive compound used in positron     emission tomography (PET) scans in identifying tau tangles (a certain protein that might be     associated with Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of     tau tangles in the brain has a relationship to cognitive status.      This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of     tau deposition. This radioactive compound is not approved by the United States Food and Drug     Administration (FDA). An MRI may also be conducted.   "
66572|NCT02414334|"     Rationale:      SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides     surgical resection for limited lung metastases (oligometastases) from colorectal cancer. High     efficacy in terms of local control of metastatic lesions treated has been shown.     Nevertheless, the precise effect of SABR upon progression-free- and overall survival in these     patients is unknown. To further evaluate and develop local treatment options in metastatic     disease, more information is necessary regarding the impact upon - and the pattern of -     disease progression of local treatment options such as SABR.      Objective:      To determine the effect upon progression free survival and upon tumorload relative to     baseline, both at one year after randomisation of immediate SABR versus delayed SABR (a     scan-and-personalise policy). Secondarily, patterns of progression, patient-reported symptoms     and quality of life will be monitored.   "
66573|NCT02414321|"     This study aims to explore the structural and functional characteristics of the pulmonary     vasculature in adult Fontan patients.      Objectives:        -  Determine the effect of pulmonary vasodilatation on indexed cardiac output during          simulated exercise.        -  Characterization of structural properties of small pulmonary arteries.   "
66574|NCT02414308|"     Erectile dysfunction is growing in prevalence all over the world and one of the most existing     disease in old age patients There is many lines of treatment concerning the status of patient     like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among     people especially diabetics, and the role of treatment still controversial in results We can     start conservative treatment and then surgical treatment if fail but the outcome still not     convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite     for probability of shortening of penis We start to use stem cell in patients have erectile     dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa     and intra dorsal penile artery under Doppler device guidance   "
66576|NCT02414282|"     This project will collect quantitative pilot data that will allow the characterization of     uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in     individuals with Progressive Posterior Cortical Dysfunction (PPCD). The primary goal is to     develop tau imaging technique as an antecedent biomarker of cognitive decline. The     investigators propose to obtain preliminary data that will support the possibility of     detecting cognitive decline in its earliest stages, before the occurrence of dementia.   "
73284|NCT02326519|"     Routine data collection will be conducted during normal sinus rhythm and AV synchronous     pacing for approximately 20 minutes. The data collected will then be processed and the P, R     and T wave amplitudes will be measured.   "
66578|NCT02414256|"     We will enroll patients submitted to breast surgery (in and outsettings) with regional     anesthesia.      The blinded observers, in the first 48 hours post-operative, will evaluate (telephone     interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10     = worst possible pain) thereby recording the treatment procedures in accordance with usual     clinical practice. At the same time we will evaluate the presence of intraoperative or     postoperative complications related to regional anesthesia, the PONV rate (post-operative     nausea and vomiting) and the analgesic/antiemetic therapy.   "
66579|NCT02414243|"     This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of     the new amino acid-based formula in infants and children aged< 12 years with documented cow's     milk protein allergy (CMPA).   "
66580|NCT02414230|"     The purpose of this research study is to evaluate tau distribution in the brain of subjects     with: ALS caused by different genetic mutations, any mutation carriers (with or without     symptoms), any non-mutation carrier, any sporadic FTD, normal controls.   "
66581|NCT02414217|"     The objective of this project is to test two interventions designed to improve     diabetes-related numeracy. Numeracy is the ability to understand and use numbers. People with     diabetes use numbers in a variety of ways in managing their condition (e.g., understanding     blood sugar values, counting carbohydrates, taking medications at the right dose and time).     As part of this project, the investigators will develop and pilot test two interventions to     improve diabetes-related numeracy: (1) a series of in-person education classes and (2) a     one-time, online diabetes education class. The investigators will look to see whether     participants in the education classes show improvements in their diabetes-related numeracy     skills, self-care behavior and attitudes, and clinical outcomes (i.e., body mass index, blood     pressure, blood sugar [A1c]).   "
66582|NCT02414204|"     Patients with stage IV and V chronic kidney disease and end stage renal disease requiring     hemodialysis at UAB Dialysis Clinics will be recruited from the UAB Vascular Access Clinic,     which has been the site for recruitment of patients requiring new vascular access for the     last 10 years.   "
66583|NCT02414191|"     The investigators aim to assess the impact of benchmarked and ranked feedback on     anesthesiologists' perioperative temperature management and subsequent patient outcomes.   "
66585|NCT02414165|"     This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus     standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine     or temozolomide) or bevacizumab administered to subjects undergoing resection for first or     second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the     inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1     ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment     with one option of standard of care (Arm SOC). Due to the prognostic influence of molecular     subgroups such as isocitrate dehydrogenase mutation, the trial will be stratified based on     this determination from the primary pathology or subsequent biopsy known locally or otherwise     determined centrally. A second stratification factor is based on the patient's Karnofsky     Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in     treatment choices for the control arm in regions, the trial will be stratified by     geographical region during the randomization process. The study will be conducted in 2 parts;     enrollment in the phase 3 will begin after phase 2 results are available.   "
66586|NCT02414152|"     The purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist)     can improve hearing thresholds in patients with sudden sensorineural hearing loss that did     not respond to oral steroid therapy. The patients to be enrolled will have recently completed     a course of oral steroids and demonstrated no change in their audiometric thresholds     following corticosteroid therapy.      The investigators will be measuring hearing thresholds (Pure tone average and word     recognition scores) before and after anakinra and correlating these findings with circulating     IL-1 levels in the patient's blood.   "
66587|NCT02414139|"     A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult     patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by     overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of     INC280.   "
66588|NCT02414126|"     Adult patients with heart failure (HF) have an increased work of breathing and are at     increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous     positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing     and improving sleep-disordered breathing in these patients.      The aim of the study is to analyze the work of breathing and objective and subjective sleep     quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the     work of breathing and improve cardiac output during wakefulness.   "
66589|NCT02414113|"     Before considering high-GVHD Negative Outcome Score (GNOS) donor selection for routine     clinical practice, this blinded prospective study will be carried out for assessment of     severe GVHD (graft-versus-host-disease) reduction associated with selecting high-GNOS donors     for allogeneic hematopoietic peripheral blood stem cell transplant. The objective of this     prospective study is to show: (a) that GVHD reductions and donor availabilities as observed     in the retrospective studies also apply to prospective samples that are collected and     processed from on-going matched unrelated transplants, and (b) that high-GNOS donor selection     readily fits into today's donor selection process, such as to facilitate access to the     benefits of GVHD reduction. The prospective study is designed to be blinded, and will not     involve specific donor selection nor any influence on clinical management or decision making     by application of the GNOS technology.      To determine if some GNOS models perform better than others across different clinical     centers, or across different recipient / donor attributes, 4 different specific GNOS models     will be evaluated. Bootstrap computational analyses have been carried out on the     retrospective data for the 4 GNOS models and will be tested and validated in this prospective     study.   "
66590|NCT02414100|"     This pilot research trial studies patient derived cancer cell lines in identifying molecular     changes in patients with previously untreated pancreatic cancer and are receiving gemcitabine     hydrochloride-based chemotherapy. Cell lines refer to samples taken from the patient's tumor     to grow for many months or years in a laboratory, and can therefore be studied     scientifically. Studying cell lines in the laboratory may help doctors understand the genetic     changes that occur to the tumor during chemotherapy that allows the tumor to resist or grow     despite treatment.   "
66592|NCT02414074|"     This pilot study conducts feasibility research to develop adaptive intervention strategies     for conduct problems prevention. The adaptive model will stipulate for whom only brief     prevention strategies are sufficient and for whom more intensive strategies are necessary.     The research will involve youth (10-17 years of age) identified by law enforcement as early     offenders and who are referred for pre-court juvenile diversion programming.   "
66593|NCT02414061|"     The purpose of this study is to investigate whether the addition of whey protein to a     breakfast high in carbohydrate content will influence acute metabolic and appetite responses,     as well as responses to a subsequent lunch meal.   "
66594|NCT02414048|"     The primary objective is the prospective determination of disease-specific and overall     survival in head and neck cancer patients who have undergone surgery, correlated to     non-invasive methods of measuring tumour hypoxia.      The secondary objective is to define tumour hypoxia using non-invasive methodology.   "
66595|NCT02414035|"     The purpose of this study is to determine whether dabigatran is associated with higher risk     of bleeding in Asia area especially in China clinical practice and whether it need to set up     a monitor system.   "
66596|NCT02414022|"     The planned analysis is a prospective cost-effectiveness (cost-utility) analysis from the     perspective of the Canadian public healthcare system, examining the costs and outcomes     (quality-adjusted life years gained) of ibrutinib-based therapy compared to a standard     therapy (bendamutine-rituximab). Collection and management of the data required for the     economic analyses (including resource utilization and outcomes) will be fully integrated into     the clinical data. Health state utilities will be derived directly from the study population.   "
66608|NCT02413866|"     The purpose of this study is to examine whether chronic moderate sleep restriction effects     the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are     participating in a dietary weight loss program.   "
66788|NCT02411526|"     This is an open-label, multiple dose, PK and safety study in patients with chronic, stable     schizophrenia or schizoaffective disorder.   "
66597|NCT02414009|"     Open-label, randomized, multicenter, Phase II trial designed to estimate the efficacy of     CAPTEM versus FOLFIRI as second line treatment in MGMT methylated, RAS mutated advanced CRC     patients who have progressed on or after first-line oxaliplatin containing chemotherapy for     metastatic disease. MGMT will be assessed centrally at Pathology Department of Fondazione     IRCCS Istituto Nazionale dei Tumori prior to enrollment. A minimum of ten 3-micron unstained     sections on charged slides of tumor will be required and methylation status will be provided     within a maximum of seven days to the Study Centers. Presence of RAS mutation will be     assessed at each local participating center. Eligible patients will be randomized in a 1:1     ratio to one of two treatment arms:        -  Arm A (experimental arm): CAPTEM        -  Arm B (control arm): FOLFIRI Study treatment will be given in cycles repeated every 28          days for Arm A and every 14 days for Arm B. Patients in Arm A will receive capecitabine          at the oral dose of 1500 mg/mq/die bid from day 1 to day 14 every 28 days plus          temozolomide 150 mg/mq/die bid starting on day 9 to 14 every 28 days. Patients in Arm B          will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of          Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only;          5-FU 7 (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2,          respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting          dose of 100 mg/m2) for two consecutive days. Treatment will continue for up to 6 cycles          in Arm A and up to 12 cycles in Arm B or up to disease progression, unacceptable          toxicity or informed consent withdrawal. Randomization will be stratified across the          treatment arms by the following predefined stratification variables: disease progression          within 9 months from the start of first-line oxaliplatin-containing chemotherapy (< vs.          ≥9 months); prior bevacizumab in combination with oxaliplatin-based chemotherapy (yes          vs. no). Efficacy assessments will be performed every 2 cycles in Arm A and every 4          cycles in Arm B until progression. The study is expected to enrol approximately 82          patients who meet the eligibility criteria.   "
66598|NCT02413996|"     The aim of this study is to assess the efficacy of virtual rehabilitation through the Virtual     Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the     functional outcomes after primary Total Knee Arthroplasty (TKA).   "
66599|NCT02413983|"     Living donor liver transplantation (LDLT) is an important option for patients with end-stage     liver disease requiring liver transplantation. When performing LDLT, the safety and well     being of donors is of the utmost importance. The conventional incision for donor hepatectomy     is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive     liver surgery throughout a single 10 cm upper midline incision without laparoscopic     assistance has been widely applied and considered to be safe and effective. Recently,     laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been     suggested to reduce morbidity and the invasiveness of living donor hepatectomy. Although     minimally invasive approach has become the surgical method of choice for many transplant     centers, little data on comparing the impact of all three different type incision in living     liver donors. In our center, the investigators have adopted three different incision     according to surgical teams. The investigators undertook this study with the aims of     comparing the pain and quality of life of donors according to type of three different     incisions and assessing any benefits to the donor due to the smaller midline incision during     the early postoperative period.   "
66600|NCT02413970|"     The purpose of this study is to obtain additional long-term safety and efficacy data on the     use of Inspire therapy.   "
66601|NCT02413957|"     The purpose of this study is to determine wether an extensive medication safety check has a     greater impact on the incidence of adverse drug events than medication reconciliation or no     intervention.   "
66602|NCT02413944|"     Study objectives: First, to determine whether intravenous injection of 1 mcg     adrenocorticotropic hormone (ACTH) through short cannula, in healthy participants, provides     reliable results of cortisol response, and whether this method would replace the conventional     technique of injecting ACTH by a needle directly into a peripheral vein. Secondly, to     determine salivary free cortisol concentration during the test in healthy controls.      Rationale of study: Intravenous injection of synthetic ACTH1-24 concentration through venous     short cannula appears to be feasible and simple method. On the other hand, injection of     ACTH1-24 by a needle directly into peripheral vein, is not infrequently complicated by     technical problems in subjects with challenging veins. The investigators suppose that, both     methods would have the same yield in predicting cortisol response.      Salivary free cortisol test has an evolving importance in assessing the adrenal function.     This test would be reliable for use in low dose ACTH stimulation (1 mcg) test. The     investigators will examine the concentration of salivary free cortisol during ACTH     stimulation test, in order to determine level range in normal controls.   "
66845|NCT02410785|"     The polyglucosamine, specification L112 is a medical device and in this clinical trial used     for weight reduction of overweight and obese participants. The rationale for this study is to     show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals     with the highest fat content.   "
66603|NCT02413931|"     Single-center, observational, prospective cohort study including patients hospitalized on the     multidrug-resistant tuberculosis ward at Marius Nasta Institute.      The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great     concern. The current study that will be conducted at the Marius Nasta Institute, one of two     nationwide excellence treatment centers for MDR-TB in Romania, is aiming to prospectively     investigate the population structure of patients with MDR-TB admitted for treatment and the     M. tuberculosis strains isolated from these patients. Transmission of MDR- strains of     Mycobacterium tuberculosis among patients hospitalized there will be also ascertained.     Additionally biomarkers for treatment response during the course of the tuberculosis therapy     will be evaluated.      The study will be conducted in a co-operation between the Marius Nasta Institute and the     German Center for Infection Research (DZIF).   "
66604|NCT02413918|"     1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct to          ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any          combination of the three thereof, in a group of patients with an index episode of a          mixed state in BD.        2. To assess background, baseline features, and behavioral components which characterize          treatment response/non-response in the acute and long term management of MS   "
66605|NCT02413905|"     The investigators performed two case-control studies in Niger and Senegal analysing fecal     microbiota to characterize the specificity of the gut microbiota alteration associated with     severe acute malnutrition (SAM).   "
66606|NCT02413892|"     Echinocandins are the drug of choice in severe candida infections. Efficacy of echinocandins     is related to concentration and area under the curve (AUC) of the drug.      Available pharmacokinetic studies found that concentration of echinocandins mainly     caspofungin is sub-optimal in severe candida infections in intensive care unit (ICU)     patients.      Higher dose of caspofungin has been proven to be safe in critically ill patients but its     impact on the ability to reach PK/PD target is unknown.      The aim of this study is to evaluate the impact of a loading dose of caspofungin on PK/PD     parameters within the first 24-hours.   "
66607|NCT02413879|"     This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound     Retraction and Protection System in Protecting Surgical Incisions from Intraoperative     Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at     the wound incision site when the CleanCision is used during surgery.   "
66609|NCT02413853|"     This randomized phase II trial studies how well combination chemotherapy and bevacizumab with     or without CBP/beta-catenin antagonist PRI-724 (PRI-724) works in treating patients with     newly diagnosed colorectal cancer that has spread to other places in the body. Drugs used in     chemotherapy, such as leucovorin calcium, oxaliplatin, and fluorouracil, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may     block tumor growth in different ways by targeting certain cells. PRI-724 may help stop the     growth of cancer cells by blocking the specific signaling pathway that cancer cells need to     grow and spread. It is not yet known whether combination chemotherapy and bevacizumab works     better with or without PRI-724 in treating patients with metastatic colorectal cancer.   "
66610|NCT02413840|"     This study expect to investigate psychological intervention (Baduanjin qigong) in COPD     patients combined with anxiety and/or depression.   "
66611|NCT02413827|"     This is a study to determine the clinical benefit (how well the drug works), safety and     tolerability of combining a) varlilumab and ipilimumab and b) varlilumab, ipilimumab,     CDX-1401 and poly-ICLC. The study will enroll patients with unresectable Stage III or Stage     IV melanoma.   "
66612|NCT02413814|"     Problematic anger is a strong predictor of failed attempts at smoking cessation. The     investigators proposed study seeks to evaluate whether a novel 8-session computerized     anger-reduction treatment improves quit rates among smokers. Smokers with elevated trait     anger will be administered transdermal nicotine patch therapy and either anger-reduction     treatment or a control intervention. They will be assessed throughout treatment and up until     three months after a scheduled mid- treatment quit date. The investigators propose to test     whether, compared to the control condition, the anger-reduction treatment will lead to: 1)     greater reductions in anger and 2) greater abstinence rates at post-cessation and at     follow-up assessments. The investigators will also test whether changes in anger-related     symptoms account for group differences in abstinence rates.   "
66613|NCT02413801|"     The events that underlie the conversion from Psoriasis to Psoriatic Arthritis (PsA) are not     well understood. This conversion occurs 30% of the time within the first 10 years of     psoriasis diagnosis. PsA patients have about a 50% chance of developing joint damage within     the first 2 years of disease. A biomarker that identifies subclinical joint inflammation in     psoriasis patients would allow for a diagnostic tool to allow for earlier intervention in     psoriasis patients and provide a better understanding of the underlying molecular     pathogenesis that may lead to development of new therapeutic targets in PsA.   "
66615|NCT02413775|"     One goal of the investigators of the Department of Anesthesiology and Intensive Care Medicine     CVK/CCM, Charité - University Medicine Berlin is a continuous improvement in the quality of     care to the patients. One focus is the freezing preoperatively during surgery, and on the     follow-up study to assess the perceived waiting times in the anesthesiology outpatient     clinic.      The project aims to quality assurance and quality improvement of the Department of     Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin .   "
66616|NCT02413762|"     This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron     regulatory hormone hepcidin as biomarkers for progression to complications in diabetes     mellitus.   "
66617|NCT02413749|"     Biologics such as anti-Tumor Necrosis Factor or TNF inhibitor (TNFi) for treatment of     Psoriatic Arthritis (PsA) has greatly reduced bone damage. This collaborative study will     provide insights into key mechanisms that underlie inflammatory arthritis and bone damage in     psoriatic joints and will catalyze biomarker discovery, identifying early biologic responders     to facilitate optimization of therapy.   "
67396|NCT02403570|"     The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable     for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation     imaging. In addition, the investigators want to study the correlation between advanced MRI     parameters and clinical disease progression.   "
66618|NCT02413736|"     In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST)     and have been treated with adjuvant imatinib for 3 years after surgery will be randomly     allocated in a 1:1 ratio to receive imatinib (Gleevec) for 2 more years (Arm A) or to stop     imatinib (Arm B). The study participants are required to have histologically verified GIST     with a high risk of GIST recurrence despite removal of all macroscopic GIST tissue at surgery     and 3 years of adjuvant imatinib. The high risk of GIST recurrence is defined as one of the     following: gastric GIST with mitotic count >10/50 high power fields (HPFs) of the microscope,     non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture. Study participants     allocated to Arm A will receive imatinib 400 mg/day for 24 months after the date of     randomization. All study participants will be followed up using blood tests and computerized     tomography (or MRI) of the abdomen. The computerized tomography examinations will be     performed at 6 month intervals. A total of 300 patients will be entered to the study. The     study hypothesis is that adjuvant imatinib given for a total of 5 years may prevent some of     the GISTs to recur as compared to patients who receive adjuvant imatinib for 3 years, and     there may be a difference in the rate of GIST recurrence between the two groups.   "
66619|NCT02413723|"     The aim of this study is to demonstrate that the rate of successful orotracheal intubation at     first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope     compared to patients intubated with classical Macintosh laryngoscope in patients requiring an     orotracheal intubation in ICU.   "
66620|NCT02413710|"     The aim of this clinical trial is to assess the effects of daily consumption of soy protein     foods on body composition, general health status and dietary intake outcomes in generally     healthy children.   "
66633|NCT02413541|"     This research project is a study to immunology changes in critically ill patients with severe     sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.   "
66789|NCT02411513|"     The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as     an acute treatment for a migraine attack. This open clinical trial will study the acute     treatment of migraine using the Cefaly® device, prior to development of a sham-controlled     trial.   "
66621|NCT02413697|"     Objectives: To assess whether embryo transfer guided by three-dimensional ultrasound (3DUS)     produces a significantly higher clinical pregnancy rate than embryo transfer guided by     two-dimensional ultrasound (2DUS).      Hypothesis: 3DUS guided embryo transfer will produce a significantly higher clinical     pregnancy rate compared with 2DUS guided embryo transfer. Design and subjects: Prospective     randomised control trial (RCT) at the Prince of Wales Hospital. Inclusion criteria include     women undergoing embryo transfer in fresh and frozen cycles. Exclusion criteria include women     aged >42 years and women whose endometrial cavity cannot be visualised adequately via US.     Power calculations indicate that 232 patients per arm are required to demonstrate an increase     of 12% in clinical pregnancy rates.      Study instruments: US examinations will be performed using a General Electric(GE) Voluson     series US machine with a standard 3D transvaginal probe. For embryo transfer, the Cooks     Guardia Access EchoTip catheter will be used.      Interventions: 3D versus 2DUS for guidance during embryo transfer. Main outcome measures:     clinical pregnancy. Secondary outcome measures: implantation rate, multiple pregnancy,     miscarriage, ectopic pregnancy and live birth rates.      Data analysis: Data processing and analysis will be performed using the Statistical Packages     of Social Sciences for Windows (SPSS, Inc). Descriptive and comparative statistical methods     will be used to analyse the primary outcomes. P-values of <0.05 will be considered     significant.      Expected results: The study arm undergoing 3DUS guided embryo transfer are expected to have     an improved clinical pregnancy rate compared with the control arm undergoing 2DUS guided     embryo transfer.   "
66622|NCT02413684|"     The purpose of this study is to test the impact of an innovative patient engagement solution     on patient's quality of life and asthma-related outcomes, and evaluate the correlation     between a patient reported outcome measure and clinical outcomes.   "
66623|NCT02413671|"     The study compared the acute effects of the supplementation of a standardized meal with     either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.   "
66624|NCT02413658|"     The purpose of this study is to investigate the potential healing properties of phenytoin.      The investigators will use the donor site of a split skin thickness graft (SSTG) to model a     basic wound in a randomized controlled trial of topical phenytoin against current best     clinical practice. The investigators aim to demonstrate a dose dependent effect. The     investigators hypothesis, based on previous clinical experience at our center and on current     available literature, that phenytoin will reduce wound healing time.   "
66625|NCT02413645|"     The mai purpose of the study is to evaluate the safety and to establish the recommended dose     of iHIVARNA-01 as a new therapeutic vaccine against HIV   "
66626|NCT02413632|"     Comparison of two screening strategies of asymptomatic sexually transmitted infections :     routine screening versus screening as reported by the risks taken by the patient, in a cohort     of HIV outpatients men who have sex with men. The aim of this study will be create and     validate a simple tool for clinicians. A digital tool will be developed will allowed     empowerment of HIV-positive men who have sex with men.   "
66627|NCT02413619|"     Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually     developed, which requires a cataract surgery.      The aim of this study is to investigate the refractive consequences of surgery for Epiretinal     membrane and cataract.      Investigators investigate the sequence of surgery in patients having surgery for Epiretinal     membrane and cataract in a prospective clinically randomized intervention trial. Patients are     randomized to 1) start with vitrectomy, 2) start with cataract surgery, 3) combined surgery.     Investigators want to find the sequence of surgery that gives the most optimal refractive     result, the most stabile intraocular lens, and the minimal loss of corneal endothelial cells.   "
66658|NCT02413216|"     Tic Disorders (including Tourette Disorder) are relatively common in school-age children and     for some children can lead to significant psychosocial and physical impairment and diminished     quality of life. Non-pharmacological treatments have been shown to be effective for reducing     tics in some children. These treatment options are desired by parents, but are not widely     available. The investigators recently developed an online, computerized, self-administered     version of CBIT called TicHelper.com. The current study will test the efficacy of     TicHelper.com in a randomized clinical trial.   "
66628|NCT02413606|"     Background: It has often been hypothesized that the frequency of follow-up for patients with     early-stage endometrial cancer could be decreased. However, studies evaluating effects of a     reduced follow-up schedule among this patient group are lacking.      Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up     schedule compared to the schedule according to the Dutch guideline.      Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients     (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a     control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline.     Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient     inclusion will take two years (if 60% of the patients participate).      Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.      Secondary: health care use, adherence to schedule, health-related quality of life, fear of     recurrence, anxiety and depression, information provision, recurrence, survival      Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant     radiotherapy is not indicated      Statistics: linear regression analyses to assess differences in patient satisfaction with     follow-up care between intervention and control group adjusted for potential pre-defined     confounders.      Expected results: Patients in the intervention arm have a similar satisfaction with follow-up     care and overall outcomes, but lower health care use and costs than patients in the control     arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced     schedule is expected to save 144.000 per year in the Netherlands.   "
66629|NCT02413593|"     This study will evaluate the antiviral efficacy, safety, and tolerability of     ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in     treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.   "
66630|NCT02413580|"     This is a multicenter, prospective, open-label, non-controlled study to assess the efficacy     and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.   "
66631|NCT02413567|"     The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR)     Procedure for the treatment of Type 2 Diabetes.   "
66632|NCT02413554|"     Delirium is a common and serious condition and is associated with adverse outcome. The     elderly who have cognitive dysfunction are expected to show delirium more frequently. It is     most likely that delirium represents a response to impaired cholinergic neurotransmission.     Investigators aimed to establish the preventive effect of the cholinesterase inhibitor,     rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation     in patients at risk of dementia.   "
66790|NCT02411500|"     The primary objective of this study is to evaluate the pharmacokinetics of various TRV734     formulations in healthy male subjects.   "
66634|NCT02413528|"     The purpose of this study is to assess the use of a mobile health intervention to improve     adherence to asthma medication among adolescents. The intervention consists of an inhaler     sensor strap to monitor asthma inhaler use and a mobile phone application to remind and     incentivize patients to use their medication. This study will assess medication use     throughout the study in patients who receive a mobile app with reminders and asthma control     as measured by the ACT [asthma control test].   "
66635|NCT02413515|"     To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8     weeks in Chinese hypertensive subjects who failed to achieve BP control with the     starting-dose antihypertensive monotherapy.   "
66636|NCT02413502|"     The objective of this protocol is to obtain biological samples through leukapheresis and     cryopreservation of cells for the future study, by in vitro assay, of immune responses after     one dose of BCG in BCG-naïve healthy adults.   "
66637|NCT02413489|"     The purpose of this study is to assess overall response rate [ORR, including complete     response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's     lymphoma [a cancer of the lymph nodes (or tissues)-NHL] and to evaluate association between     ORR and CD38 expression level in order to determine a threshold for CD38 expression level in     each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed     or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.   "
66638|NCT02413476|"     The study aims to compare the clinical outcomes between robotic-assisted and     laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and     safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who     are more suitable for robotic gastrectomy.   "
66639|NCT02413463|"     Prospective randomized interventional comparative study   "
66640|NCT02413450|"     Human induced pluripotent stem cells (hiPSCs) have driven a paradigm shift in the modeling of     human disease; the ability to reprogram patient-specific cells holds the promise of an     enhanced understanding of disease mechanisms and phenotypic variability, with applications in     personalized predictive pharmacology/toxicology, cell therapy and regenerative medicine. This     research will collect blood or skin biopsies from patients and healthy controls for the     purpose of generating cell and tissue models of Mendelian heritable forms of heart disease     focusing on cardiomyopathies, channelopathies and neuromuscular diseases. Cardiomyocytes     derived from hiPSCs will provide a ready source of disease specific cells to study     pathogenesis and therapeutics.   "
66641|NCT02413437|"     The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound     in percutaneous biopsy for liver occupied lesion.   "
66642|NCT02413424|"     The purpose of this research study is to examine whether sugar-replacement sweeteners that     are currently on the market (ex. Sucralose, which is in Splenda) change how well the body     works to control blood sugar.   "
66688|NCT02412826|"     The purpose of this study is to conduct a pilot test of an abdominal acoustic sensor on     patients with acute pancreatitis to determine the correlation of acoustic signals with     symptoms reported by the patient.   "
66689|NCT02412813|"     This is a prospective, randomized, multi-center, metal hypersensitivity study comparing     OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty     (TKA).   "
67121|NCT02407184|"     Understanding the microbiome's important role in human health, the investigators wish to     determine how the development of the infant microbiome is impacted by delivery mode,     comparing natural vaginal birth to scheduled C-sections. Investigators will look at the oral,     nasal, skin, vaginal and fecal bacteria of 78 mothers and their infants from birth to age 1.   "
66643|NCT02413411|"     A randomized, controlled design will be utilized to examine and compare the effectiveness of     the proposed educational intervention, which includes a combination of an educational     decision aid and motivational interviewing with attention control on select key     patient-centered and process of care outcomes. The study sample will consist of approximately     450 African-American patients with osteoarthritis of the knee. Patients will be recruited     from the University of Pennsylvania Health System and the Philadelphia VA Medical Center and     will be randomized to one of the two study arms.      The immediate goal of this randomized controlled trial is to assess the effect of a     high-quality, evidence-based, patient-centered educational intervention supplemented with     targeted counseling (motivational interviewing) on African American patient preferences,     expectations, and the likelihood of achieving a referral for surgical evaluation. The     long-term goal of this research is to widely implement a patient-centered educational     intervention targeting African Americans who are potential candidates for joint replacement,     in a national effort to reduce and ultimately eliminate racial disparities in the utilization     of this effective treatment option.      Study Aim:To examine the effect of the knee osteoarthritis Decision Aid (DA)/Motivational     Interviewing (MI) intervention on orthopedic surgery referral rates for African American (AA)     patients. Hypothesis: Compared to attention control, the DA/MI intervention will lead to     higher orthopedic surgery referral rates for AA patients.      Secondary aim: To examine the effect of the DA/MI intervention on the rate of knee     replacement receipt among AA patients. Hypothesis: AA patients randomized to receive the     intervention will have higher rates of knee replacement compared to those in the attention     control group.   "
66644|NCT02413398|"     The purpose of this clinical research study is to determine whether dapagliflozin can improve     (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal     impairment.This study will be conducted at approximately 100 centres from countries across     North America and European regions. It is planned to randomize a total of 302 patients.   "
66645|NCT02413385|"     The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle     prescription (Rx) program, supported by in-person coaching and innovative health     technologies. The program improves the health of Canadians and reduces their risk for chronic     disease by tackling three major risk factors that are shared across a number of chronic     diseases: physical inactivity, sedentary behaviour and poor diet. Each HeS participant     receives an individualized healthy living Rx for exercise, physical activity (step counts)     and healthy eating, supported by coaching and technology tools to promote long-term health     behaviour change. For this study, the investigators will undertake a 6-month pilot pragmatic     randomized controlled trial (RCT), conducted within 5 clinic settings in Southwestern     Ontario. The primary aim is to conduct an outcome evaluation to determine the effectiveness     of the HeS program in helping at-risk individuals increase physical activity levels, improve     eating habits, and improve other health behaviours and health indicators.   "
66646|NCT02413372|"     The purpose of this study is to determine whether BMS-986036 is effective in the treatment of     subjects with Non-alcoholic Steatohepatitis (NASH).   "
66647|NCT02413359|"     The patients with complications of COPD and asthma have features mixed with two diseases,     COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms     overlapped with asthma, however, no sufficient data exist in Japan for estimating the     prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the     proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary     objectives are To explore the features of history of COPD exacerbations, symptoms,     eosinophilic inflammation and patient background in patients with ACOS, to clarify the     history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic     inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in     patients with COPD. This is a cross-sectional study targeting COPD patients receiving     outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and     DBL would be locked by 3Q 2015.   "
66648|NCT02413346|"     Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral     sarecycline in the long-term treatment of subjects with moderate to severe facial acne     vulgaris.   "
66651|NCT02413307|"     **PLEASE NOTE** this study is currently open only to clients on the waiting list at the     Centre for Trauma Resilience and Growth, UK.      The project will involve adapting and implementing a five minute daily self-practice     compassion-focused intervention and evaluate its impact on psychological and physiological     factors associated with trauma. It aims to offer a novel intervention which may facilitate     further benefits from trauma specific therapy. This would be a unique use of self-practice     Compassion Focused Therapy (CFT) specifically for trauma clients. Previous research has found     that many factors can impact on client's benefitting from therapy, including depression,     anxiety and self-criticism. These things also get in the way of being compassionate towards     oneself, and this can be a difficulty for people who have experienced traumatic events.     Service users have identified that additional support before trauma specific therapy can be     useful and this may offer a positive use of time whilst on therapy waiting lists.      Hypotheses:      i. A brief CFT intervention will decrease levels of depression, anxiety, stress and increase     baseline Heart Rate Variability.      ii. The compassion focused intervention will increase experiences of self-compassion, social     safeness, and reduce levels of self-criticism.      iii. High 'fear of compassion' will moderate the impact of the intervention and result in     smaller changes in depression, anxiety, stress and post traumatic change.      Clients of the Centre for trauma, resilience and growth will be approached to participate in     the study. All participants will have experienced trauma for which they are seeking     psychological support. The current compassion focused intervention will be offered to     participants on the waiting list for trauma specific therapy at the trauma centre. Each     participant will be asked to practice the intervention in their own time over a period of     three weeks. There will be initial assessments, repeated assessments following the     intervention, and repeated assessments pre and post trauma specific therapies engaged in.   "
66652|NCT02413294|"     The investigators are aiming to examine the acceptability and feasibility of a portable     bright light therapy instrument to improve sleep disturbance in a preventive intervention for     depression. The investigators will conduct an intervention that trials the use of bright     light glasses called re-timers as a preventive intervention in older adults with sleep     disturbance and subsyndromal symptoms of depression.   "
66653|NCT02413281|"     This study will evaluate the abuse potential of ALKS 5461.   "
66654|NCT02413268|"     A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial     artery occlusion after transradial catheterization.   "
66655|NCT02413255|"     The purpose of this study is to characterize the safety, tolerability, and pharmacokinetics     of ascending single- and multiple-doses of TAK-020 in healthy participants.   "
66656|NCT02413242|"     Intensive Care Unit (ICU) acquired pneumonia, including ventilator-associated pneumonia, is a     frequently occurring health-care associated infection, which causes considerable morbidity,     mortality and health care costs. Important pathogens causing ICU pneumonia are Staphylococcus     aureus and Pseudomonas aeruginosa. The epidemiology of ICU pneumonia and patient-related and     contextual factors is not fully described, but is urgently needed to support the development     of effective interventions.   "
66657|NCT02413229|"     The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and     a Placebo in patients with moderate to severe scalp psoriasis.   "
66719|NCT02412423|"     In beijing model for haploidentical transplant, the rate of acute graft-versus-host disease     (GVHD) from maternal or collateral donors was significantly higher than that from other kins.     To reduce the GVHD incidence from maternal or collateral donors, post-transplantation     cyclophosphamide is planned to be added into the protocol in beijing model.   "
66659|NCT02413203|"     Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated     interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target.     Global deletion of mPGES-1 in mice suppresses prostaglandin (PG) E2 and augments PGI2 by PGH2     substrate rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not     cause a predisposition to thrombogenesis and hypertension. However, cell-specific deletion of     mPGES-1 reveals that the predominant substrate rediversion product among the prostaglandins     varies by cell type, complicating drug development. The research team has developed an ultra     performance liquid chromatography/ tandem mass spectrometry (UPLC-MS/MS) technique that     allows the quantification of a wide range of lipids beyond the prostaglandin pathway     (leukotrienes, anandamide and the 2-arachidonylglycerol cascades).      This study is designed to examine different pathway interventions from the arachidonic acid     cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human     blood in vitro (Part A) and ex vivo (Part B). In Part B, healthy volunteers will be asked to     take a single, therapeutic dose of celecoxib and blood and urine samples will be collected     before and after drug administration. Collected blood will be stimulated ex vivo, and lipids     and their metabolites will be measured in blood and urine, respectively. The investigators     expect that lipid profile from ex vivo hWBA done on celecoxib-treated subjects will     recapitulate findings from the in vitro hWBA received with celecoxib-treated human blood     (Part A).   "
66660|NCT02413190|"     This is a cross-sectional single visit study to determine bone health in individuals with     FSHD.   "
66661|NCT02413177|"     The overall goal of the proposed study is to develop and test real time neurofeedback     (EEG-RTNF) as a tool to augment Mindfulness Based Stress Reduction (MBSR). This study is     based on the theoretical model that (1) mind-wandering and self-referential processing are     associated with stress, (2) meditation redirects the wandering mind toward present-centered     awareness, (3) meditation also decreases activity in hubs of the default mode network (DMN)     involved in mind-wandering and self-referential processing, and thus (4) meditation leading     to decreased activity in these hubs should lead to reduced stress and improved health and     well-being. Milestones include: (1) test whether EEG-RTNF from the PCC during meditation     augments MBSR in novices; and (2) test whether MBSR with EEG-RTNF from the PCC leads to     real-world outcomes in reduced stress and improved attention.   "
66662|NCT02413164|"     The aim of the investigators' study would evaluate the effectiveness of a multimodal exercise     program on health related quality of life, symptoms and cardiometabolic parameters in     patients with schizophrenia.      DESIGN: Randomized controlled trial. SUBJECTS OF THE STUDY: People with schizophrenia who     receiving treatment in Regional Hospital of Malaga. INTERVENTION: DATA ANALYSIS: descriptive     statistics, measuring central tendency and dispersion of the variables study. Inferential     statistics will be made between intervention of key variables and outcome.   "
66682|NCT02412904|"     rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF.     However, there is a debate in the literature which one is better to induce ovulation in     patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.      The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences     among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.   "
66663|NCT02413151|"     Cardiac resynchronization therapy(CRT) is recommended to reduce mortality and morbidity in     chronic heart failure(CHF) patients New York Heart Association(NYHA) class III-IV who are     symptomatic despite optimal medical therapy, with a reduced left ventricular(LV) ejection     fraction(LVEF) and prolonged complex QRS. CRT improves the prognosis however, despite the     improvement, all major trials have demonstrated that one third of the patients are     non-responders to CRT. Three months after the CRT implant, the responders have a significant     increase in endothelial function(EntF), a decrease in the LV end-systolic volume, and     increase in LVEF, 6 minute walk test(6MWT), improvements in NYHA class and quality of life.     It is currently unknown if adding an exercise training(ExT) program following CRT provides     better clinical outcomes than CRT alone. Prior studies on CRT and ExT have been preliminary     in nature, but suggest small improvements in functional capacity(FC). The correction of     endothelial dysfunction is associated with a significant improvement in exercise capacity     evidenced by a 26%increase in peak oxygen uptake. These findings are important because CHF     patients with the greatest sympathetic activation and the most reduced EntF have the poorest     prognosis. Our experience with coronary artery disease patients, and most recently data in     patients with CHF show that an ExT program that combines aerobic exercise(AE) and resistance     exercise training are more effective than an AE program alone, and the aerobic interval     training showed better improvements than continuous endurance training. It is unknown how CHF     with more severe functional limitations responds to ExT and, more important, the explanation     of the physiological mechanism that can explain the improvements as a consequence of ExT.     This lack of scientific information is urgent since this is the group of patients that     normally is targeted for CRT. The investigators propose to use a stratified randomized     longitudinal study to determine the additional effects of a 6 month ExT in addition to CRT in     NYHA stage III-IV HF patients. The aims of the study are:1-to determine whether a long-term     ExT program follow the CRT provides better clinical outcomes than CRT alone and 2-To identify     the mechanisms of the hypothesize improvement. The results of this project will represent an     important contribution by understanding the role of ExT after CRT NYHA stage III-IV heart     failure(HF) patients, an understudied population with poor clinical outcome. Understanding     the potential mechanisms associated with clinical improvement and outcome is essential for     the rehabilitative process to develop new innovative therapies in this high risk population.     The investigators will use state-of-art methods including an integrated assessment autonomic     nervous system(ANS) and arterial function using 123I-MIBG scintigraphy.   "
66664|NCT02413138|"     The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of     somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy     stage. Upon completion of the PK/PD stage, the PK/PD profiles for the GHD children in this     study will be compared to the PK/PD profiles for the GHD children treated in the Western     study Phase 1b/2a study (Protocol 12VR2) and identify the somavaratan dose to be used in the     Phase 3 stage in Japan. The Phase 3 stage will continue dosing for 12 months to obtain safety     and efficacy data on 48 subjects.   "
66665|NCT02413125|"     Rhinosinusitis is one of the most prevalent diseases within the United States and leads to     decreased quality of life for patients suffering from this condition. A foundation in     treatment for rhinosinusitis is nasal saline irrigations, which are administered through an     irrigation bottle. The irrigation bottles are prone to contamination by bacterial and fungal     species despite proper maintenance.      A new commercially available irrigation solution has been created using chitosan, a natural     polysaccharide with antibacterial and antifungal properties. This research project will     examine the ability of chitosan to decrease or prevent contamination of irrigation bottles     after 1 month use by adult patients with rhinosinusitis.      Participants in this project will use either saline or chitosan irrigation solution for 1     month and then switch to the other solution for 1 month. Following 1 month of use, the     irrigation bottles will be cultured to determine if chitosan irrigation solution decreased     the contamination of the irrigation bottles.   "
66666|NCT02413112|"     It is well accepted that physical activity in the form of resistance training produces a wide     variety of neuromuscular-skeletal and health benefits. It is recommended in Finland that     older individuals (over 65yr) should perform resistance training twice per week.      Unfortunately, only approx. 5% of older individuals fulfill this recommendation. As Finnish     society grows ever older, research should focus on the specific needs of this group and how     to improve participation in physical activity, which may ultimately lead to modification of     physical activity recommendations - resistance training recommendations are currently the     same for young and older adults and do not include specific recommendations on the type of     resistance training. However, these recommendations appear to have been developed for best     possible improvements in maximum strength and muscle size.      Therefore, it is of great importance to identify the number of resistance training sessions     per week required to induce improvements in physical fitness, metabolic and bone health     status, and importantly the reasons for adherence to/drop-out of resistance training     interventions (e.g. motivation to train) in a multi-discipline study. This knowledge would     benefit policy makers to update current recommendations for resistance training and to devise     strategies to advise realistic targets for resistance training in the older, particularly the     less-educated, age group (e.g. TELI-strategy for 2020).      The present study will include a 12-month resistance training intervention with a 12-month     follow-up period. Interviews and questionnaires will assess psychological/sociological data     and will be collected from both drop-out subjects and those that complete the intervention.     Neuromuscular performance and functional capacity will be tested using conventional methods,     along with body composition, bone density, and blood tests for metabolic markers of health.     Diet and other physical activity will be controlled throughout the intervention period.     Measurements are to be performed every 3 months.      It is expected that 5 international peer-reviewed articles will be published in 2016-2017.     The data will be presented at international and national conferences in 2015-2017. Finally,     results of the entire research will be published in national peer-reviewed journals (e.g. The     Age Institute's Raportteja). All subjects will be invited to attend an information meeting     where group results will be presented and explained.   "
66667|NCT02413099|"     Background: KBMSI-2, which is the herbal formular consisted of Ginseng Radix Rubra, Dioscorea     tenuipes, Cornus officinalis Sieb. Et Zucc, Lycium Chinese Mill, Curcuma logna Linn, Honey,     improved the erectile function by preserving the smooth muscle content and inhibiting the     fibrosis of the corpus cavernosum in STZ-induced diabetic rat model. In this study, the     researchers investigated the efficacy and safety of the herbal formula (KBMSI-2) in the     treatment of ED.      Material and Methods: Patients were instructed to take investigational products (KBMSI-2 6g     or placebo) twice a day for 8 weeks at least 1 hour after food intake. The primary efficacy     variable was the change in the EF domain scores of the IIEF questionnaire from baseline.     Secondary efficacy measures included change in all domain scores of the IIEF from baseline,     change in question 2 and 3 of the SEP2,3, from baseline.   "
66668|NCT02413086|"     Diabetic Foot as the popular chronic complications of diabetes, is one of the main factors     leading to limb amputation, it was reported that the amputation rate is 15 times of the     non-diabetic patients. Common surgical amputation is not only about high plane amputation but     also bring a tremendous mental stress to patients which may affect the quality of life     seriously. Diabetic foot patients facing the great risk of serious infection, endotoxemia ,     and septic shock which could be the main cause of death before amputation. It become an     important topic that how to control the infection, reduce the amputation plane, save the     function as possibility, and improve the life quality of the patients as well.      This study is based on years of clinical experience of and brings out early-stage     amputation concept firstly in China with a systematic exposition, experimental research and     clinical research. Early-stage amputation refers to cut in the normal tissue from the     inflammatory tissue at the junction line of limbs, in order to achieve more retained stump,     block endotoxin absorption and improve the quality of life of patients. External therapy of     herbs chitosan can promote granulation tissue regeneration and control of local infection, it     solved the problem of difficult wound healing and it is a reliable guarantee of early-stage     amputation.   "
66669|NCT02413073|"     There are no studies in the literature evaluating the vibration of the whole body in patients     with chronic renal failure. The study aims to assess the effectiveness of whole body     vibration in patients with renal disease in the final phase in the interdialytic period. It     will be a randomized, triple-blind, controlled and randomized. The pilot study will be 20     individuals initially. In intervention patients will be randomly divided into two groups:     sham platform and platform. As a result it is expected that the training of whole body     vibration may promote patient compliance, since it requires less physical effort for     implementation and greater comfort in the application, thus allowing the sedentary and / or     less active patients can benefit by to minimize the harmful effects of physical inactivity     associated with pre-existing kidney problems.   "
66670|NCT02413060|"     The purpose of this study is to determine whether the long-term effects of high-intensity     progressive resistance training could improve glucose and lipid metabolism in chinese type 2     diabetes.   "
66671|NCT02413047|"     The immunogenicity of anti-tumor necrosis factor alpha (anti-TNF) therapy in inflammatory     bowel disease (IBD) is an important cause of loss of response to therapy that may lead to     escalation of dose or discontinuation of therapy. Antibodies may develop to infliximab (ATI)     or to adalimumab (ATA) and cause this loss of response, also known as a secondary loss of     response. An alternative approach is the addition of immunomodulator (IM) therapy to     counteract the antibody response and regain efficacy of the biologic medication. The     investigators' goal is to treat patients' who have lost response to adalimumab or infliximab     with an immunomodulator with the goal of eliminating the circulating antibodies to the     anti-TNF and restoring efficacy.   "
66672|NCT02413034|"     Total joint replacement is a common clinical practice for patients suffering from disabling     arthritis, since it provides significant pain relief and functional recovering. Nevertheless,     its outcome is compromised by complications such as periprosthetic joint infection (PJI),     which is reported to occur in 1 to 4% of primary total knee arthroplasties (TKA), and     approximately 1% of primary total hip replacements (THR). Despite all efforts to restrain     PJI, its prevalence may reach even higher proportions if patients undergo a resection     arthroplasty or irrigation and débridement for infected prosthesis. That said, timely     diagnosis and early isolation of the infected microorganism is utterly important, if proper     care is to be delivered.      The gold standard for the diagnosis of PJI is the isolation of a microorganism from the     intraoperative cultures, combined with the sonication from retrieved joint implants1. This     technique applies sound energy to agitate and disrupt biofilm, dislodging adherent bacterias     to the bone cement, which has been proved to be a more sensitive method than conventional     intraoperative cultures. False-negative percentages were reported to be 15% in patients who     did not receive extended antibiotic prophylaxis and 60% if extended antibiotic therapy was     administered.      Regardless of an adequate clinical, radiographic and surgical suspicion confirming PJI, an     organism is not always successfully isolated from the intraoperative cultures, which     increases false negatives results. This fact has been trying to be explained by several     authors, some of which postulate that antibiotic prophylaxis could interfere with the     isolation of the microorganism from the intraoperative cultures. As a result, and acting     accordingly to this hypothesis, preoperative antibiotics are often withheld until     intraoperative cultures are obtained, hoping that tissues are not loaded with antibiotics.     Nevertheless, one should be aware of the adverse consequences of this practice that may     result in systemic dissemination of infection.      Moreover, Ghanem and Stephen recently concluded that antibiotic prophylaxis does not     interfere with the isolation of the microorganism from intraoperative cultures, despite being     studies that lack statistical power.      Therefore, it is clear that reported studies in this field support both preoperative     antibiotic prophylaxis administration, as well its withdrawal, until intraoperative cultures     are obtained.      This decision in the department study depends exclusively on the treating surgeon judgment.     In fact, 48% of all patients admitted at the study hospital with PJI receive preoperative     antibiotic prophylaxis, which could be related to higher false-negative intraoperative     culture and sonication results. Thus, the investigators add substances with chelation     properties to hemoculture containers and then inoculate sonication samples. This practice     offsets antibiotic interference with intraoperative cultures and has proved to enhance     microorganism detection rates.      That said, and given the lack of scientific evidence about this clinical practice the     investigators are willing to engage a prospective randomized double-blind clinical trial,     that will allow us to determine whether intraoperative cultures and sonication samples are     affected by antibiotic prophylaxis.   "
66673|NCT02413021|"     The purpose of this study is to determine whether deferasirox is effective in the treatment     of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).   "
66674|NCT02413008|"     This is a phase II, prospective, randomized, double-blind, placebo-controlled, international     (Spain and Sweden) and multicentre study.      In the setting of postmenopausal hormone receptor positive breast cancer, treatment with     aromatase inhibitors (AIs) is the most effective and well-studied therapy. Vaginal dryness is     one of the most frequently reported symptom caused by this adjuvant therapy which may lead to     a reduced adherence in breast cancer women.      This study will explore the safety of 0.005% estriol vaginal gel in this oncological context,     to demonstrate that this medicinal product is a safe option to treat the vaginal atrophy     caused by AIs, without a clinically relevant influence in gonadotropins or systemic estrogen     levels.      The main objective is to evaluate the levels of Follicle Stimulating Hormone (FSH) after     treatment with 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women     with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs)     in the adjuvant setting and symptoms of vaginal atrophy.   "
66720|NCT02412410|"     This is a pilot study designed to elucidate sleep/wake patterns and associated cognitive     efficacy of laborists involved in shift work at Mayo Clinic Rochester.   "
66675|NCT02412995|"     The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well     as on metabolic profiles were examined in overweight or obese male subjects. The study was     conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen     subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test     meals contained either sea buckthorn, strawberry or no berries and added sucrose to match     with respect to sucrose content. Blood samples were collected at baseline and several times     postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min     until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also     collected at baseline and at several time intervals until 24 hours. Blood and urine were     subjected to metabolic profiling to investigate potential biomarkers of berry intake.   "
66676|NCT02412982|"     This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ     between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed     on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two     enoxaparin dosing strategies.   "
66677|NCT02412969|"     This study is to examine the onset of pain relief with two different methods of labor     epidural. The traditional labor epidural involves the placement of numbing and anti-pain     medicine in the epidural space which surrounds the spinal cord. In order to take effect, the     medication has to cross a layer of tissue called the dura. In the current study, the same     medications are placed in the epidural space after the dura is punctured with a fine needle.     This research, will help evaluate whether this technique will result in earlier onset of pain     relief.   "
66678|NCT02412956|"     Despite the great health benefits associated with smoking cessation in pregnancy to both     mother and baby, few studies to date have examined the applications of text messaging or     other communication technologies for smoking cessation in this population. This project is     the first step in developing a new dissemination strategy for reaching pregnant smokers. This     research will explore how a state-of -the-art, interactive and intensive, text messaging     program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program     may have the potential to reach pregnant smokers who are not currently being reached with     traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback     from pregnant smokers and recent quitters (in the past month) about the concept of     SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in     SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is     consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative     evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To     measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by     responding to different types of recruitment messages.   "
66679|NCT02412943|"     This study evaluates the transfusion of fresh frozen plasma containing the enzyme PAPP-A2     into the a female adult. This female adult has a mutated version of PAPP-A2 that prevents the     unbinding of IGF-1 from IGF binding proteins. The investigator's hypothesize that transfusion     of plasma with donor PAPP-A2 will lead to the unbinding of IGF-1 from its binding proteins     and that they will be able to measure free IGF-1 in the blood of this female adult.   "
66680|NCT02412930|"     Paravertebral block has been widely used for analgesia. The aim of this study,comparison of     the effect of ultrasound-guided paravertebral block versus intravenous tramadol for     postoperative pain control in percutaneous nephrolithotomy.   "
66683|NCT02412891|"     Evaluation of UroShield device impact upon side effects and complications of urinary     catheter usage.      The use of urinary catheters is a common medical practice in the perioperative setting.      As such, it exposes the patient to certain comorbidities, including urinary tract infections.      The infectious process is known to begin with a development of a biofilm on the catheter's     surface. This fact makes it an attractive target for UTI prevention technology.      Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the     efficacy of this method in vivo.   "
66684|NCT02412878|"     The purpose of the study is to compare once-weekly carfilzomib dosing in combination with     dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in     subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib     and an immunomodulatory agent (IMiD).   "
66685|NCT02412865|"     The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program     to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.      In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers     who have been recruited from users of text4baby - the first large scale mobile health     application in the United States. Developed and operated by Voxiva and Healthy Mothers,     Healthy Babies (HMHB)—collaborators in this program -text4baby is a free national service     that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and     delivered more than 150 million health messages to them including messages encouraging them     not to smoke during pregnancy and referring them to quit lines.      Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher     levels of knowledge about the dangers of second hand smoke and the benefits of smoking     cessation for mothers and their infants than text4baby only users.      Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly     higher rates of calling a quit line, discussions with their health provider and/or use of     cessation counseling than those who receive Text4baby alone.      Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more     favorable quitting outcomes compared with text4baby alone.   "
66686|NCT02412852|"     In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks     with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.     Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications     affects on pain following treatment will also be recorded.   "
66687|NCT02412839|"     This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39     (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males     and 15 females). The sublingual microcirculation will be examined with the incident dark     field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims to     compare the differences of microcirculation among the three groups and between genders.   "
66690|NCT02412800|"     Postoperative acute lung injury (ALI) during the first 72 hours after liver transplantation     is not uncommon. Injury may occur because liver transplantation is often associated with     prolonged operative time, large volumes of fluid administration and transfusion, as well as     inflammatory responses related to ischemia-reperfusion injury. For more precise perioperative     fluid and hemodynamic management, modern monitoring systems, such as the pulse contour     cardiac output (PiCCO) system, have been devised and reported in recent years. The PiCCO     system uses the thermodilution technique to determine the cardiac index (CI) and thoracic     fluid indices such as the intrathoracic blood volume index (ITBVI), extravascular lung water     index (EVLWI), and pulmonary vascular permeability index (PVPI), all of which may reflect     pulmonary fluid and injury status. However, perioperative changes in thoracic fluid indices     in liver transplantation and their associations with postoperative ALI are not yet clear. In     this study, the investigators aimed to determine patterns of change in perioperative thoracic     fluid indices and compare these changes in recipients who did or did not develop     postoperative ALI. Furthermore, the investigators will also try to determine the potential     risk factors following liver transplantation.   "
66691|NCT02412787|"     This extension study will allow participants that completed Study HGT-HIT-094 to continue     receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving     Elaprase treatment and begin concurrent IT treatment for those that did not received     idursulfase IT treatment in Study HGT-HIT-094.   "
66692|NCT02412774|"     The purpose of the present study is to evaluate the effect of replacing diet beverages with     water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic     risk factors of diabetic obese and overweight female adults when they are in a     multidisciplinary weight loss plan.   "
66693|NCT02412761|"     Children are increasingly being diagnosed with essential hypertension and the absence of     comparative effectiveness research in antihypertensive therapies has contributed to     considerable differences in prescribing practices among physicians treating children with     essential hypertension.      This study will consist of a series of systematically-administered n-of-1 trials among     children to verify the need for ongoing antihypertensive treatment and if so, to identify the     preferred single drug therapy.   "
66694|NCT02412748|"     The number of children living apart from their fathers has grown nationally, and the greatest     percentage is evident among African American (AA) families; two-thirds of all African     American children live in households without their biological father. Research supports the     importance of positive fathering in the lives of children. But in order for children to     benefit from their fathers' involvement, the father-child relationship must be timely and     sustained. This study will test culturally relevant interventions aimed at increasing     non-resident (not living with the child) AA fathers' involvement with their children.   "
66696|NCT02412722|"     The purposes of this study are to: evaluate the safety and tolerability of MLN0128 milled     active pharmaceutical ingredient (API) capsules administered both as a single agent and in     combination with paclitaxel, to characterize the effect of a high-fat meal on the     pharmacokinetics (PK) of MLN0128 milled API capsules, and to characterize the PK of MLN0128     milled API capsules when administered on an empty stomach approximately 24 hours after     paclitaxel infusion.   "
66697|NCT02412709|"     The purpose of this project is to test a new, very compact, 12-lead ECG device as a way to     detect long QT syndrome (LQTS) in infants. The device -- called QTScreen -- was developed in     Phase I of this project.      In Phase II, the goals are to test the capacity of the device for LQTS screening in newborns     and to obtain prevalence data on LQTS in California.      The 4 main objectives are:        1. To validate the capacity of QTScreen for LQTS screening in newborns.        2. To determine the extent to which parents are able to use QTScreen on their babies at          home.        3. To survey end-user experience and opinions.        4. To estimate the LQTS prevalence in California.   "
66698|NCT02412696|"     This study is testing the hypothesis of whether continuous positive airway pressure (CPAP)     therapy improves placental histopathology and secretory function. The main aims of the study     are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both     common highly morbid conditions.   "
66699|NCT02412683|"     Subgroups of patients with radically operated colorectal cancer can have a better prognosis     by over six months are treated with chemotherapy. This beneficial effect may be enhanced     somewhat by providing a combination of chemotherapy and the addition of oxaliplatin. It is     known that this treatment additions increase the risk of neurotoxic side effects such as     sensitivity to cold, numbness and tingling in hands or feet, muscle cramps, pain, taste     disorders and swallowing difficulties.      The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant     chemotherapy experience neurotoxic effects and if the experience of the symptoms change over     time during treatment and how symptoms affect patients' daily lives and quality of life.   "
66700|NCT02412670|"     This phase II trial studies how well giving chemotherapy before surgery works in treating     patients with aggressive upper urinary tract cancer. Drugs used in chemotherapy, such as     methotrexate, vinblastine, doxorubicin hydrochloride, cisplatin, gemcitabine hydrochloride,     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Removing the     affected upper urinary tract by surgery is the recommended treatment for upper urinary tract     cancer, but can cause loss of kidney function and prevent patients from being able to receive     chemotherapy after surgery. Giving chemotherapy before surgery, when the kidneys are working     at their maximum, may allow less tissue to be removed during surgery and may be more     effective in treating patients with high grade upper urinary tract cancer.   "
66701|NCT02412657|"     Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous     dexamethasone increases the analgesic duration of a single-shot interscalene block with     ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two     different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration     of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is     equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot     interscalene block with ropivacaine.   "
66702|NCT02412644|"     12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla®     (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy   "
66703|NCT02412631|"     Some individuals smoke with the perception that smoking helps control body weight. Smokers     gain an average of as much as 10 pounds in the months following smoking abstinence, with     heavier and more-dependent smokers gaining more weight. T The Mayo Clinic Nicotine Research     Program will randomize 100 nondiabetic, overweight or obese adult smokers to active     lorcaserin or placebo for 24 weeks; all of the subjects will receive open-label varenicline     for 12 weeks. The purpose of this study is to assess the efficacy of a 24-week course of     lorcaserin for decreasing weight gain after stopping smoking.   "
66704|NCT02412618|"     A randomized double--‐blinded comparison of same--‐day mifepristone and misoprostol with     misoprostol only for cervical preparation in second--‐trimester surgical abortion in 100     women at 14 0/7--‐19 6/7 weeks gestation.   "
66705|NCT02412605|"     Records of women who had trophectoderm biopsy for sex selection over the last 3 years will be     reviewed and its outcome will be compared to other records of women who had IVF/ICSI without     embryo biopsy.   "
66706|NCT02412592|"     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of     cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the     satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients.     However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur     in some patients who achieved HBeAg seronconversion by interferon treatment. In this study,     the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg     seronconversion after interferon treatment and the factors associated with viral and clinical     relapse will be observed.   "
66707|NCT02412579|"     The purpose of this study is to determine whether genetic markers unique to liver cancer are     present and to assess usefulness as a diagnostic tool.   "
66728|NCT02412306|"     Open-label combined two-part multi-center clinical study to evaluate the efficacy, safety,     and tolerabillity of blinatumomab in adult and pediatric Japanese subjects with R/R     B-precursor ALL.      The Phase 1b part will investigate the safety, efficacy, PK and PD of blinatumomab in adult     Japanse subects with R/R B-precursor ALL to determine the MTD (maximum tolerated dose) in     both adult and pediatric subjects. Once a dose has been selected in the Phase 1b part, the     Phase 2 part will assess the safety and efficacy of the recommeded dose level of blinatumomab     identified in the Phase 1b portion of the study in the adult study population.   "
66754|NCT02411968|"     Currently there is no consensus on post procedural follow up imaging following percutaneous     cryoablation of renal tumors. Interpretation of conventional contrast enhanced imaging (CT     and MRI) during follow up can be very challenging. The objective of this study is to evaluate     the feasibility of early evaluation of the therapeutic effect by performing early follow up     imaging after percutaneous MR-guided cryoablation of pT1a renal cell carcinoma using     111In-Girentuximab-DOTA SPECT CT imaging.   "
66708|NCT02412566|"     While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition     (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early     PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the     calories that are lost from this relative decreased dose of lipids can be provided by     adjusting the dextrose content of the PN solution and providing a higher glucose infusion     rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is     inadequate. Inadequate growth is a direct cause of poor outcomes including poorer     neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of     their often already damaged intestine. These outcomes can lead to severe disability and     death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing     must have a greater intake of lipids to meet their needs for weight, length, and head     circumference growth.      SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid     sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty     acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids,     medium-chain triglycerides showing a faster metabolic clearance than long-chain     triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what     is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1     g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. Because this     product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s     for the liver and provides more than enough omega-6s to meet essential fatty acid     requirements. Its use in situations in which growth is inadequate in babies who must be     restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase     their chances of both a good neurological outcome and survival.      Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help     promote good growth while reducing the severity (or seriousness) of liver disease or help put     an end to liver disease in infants.   "
66709|NCT02412553|"     The study is proposed as a 2-year single site, open-label clinical trial of enteral nutrition     or the specific carbohydrate diet in patients with active CD or UC. Patients seeking care in     the outpatient clinics of the Division of Gastroenterology at Massachusetts General Hospital     will be approached for participation in the trial during their routine outpatient     appointments. All patients are required to have a diagnosis of CD or UC confirmed using     standard clinical, endoscopic, and histologic criteria. Eligible patients will complete an     office visit to confirm eligibility for the study and informed consent will be obtained. They     will then be scheduled for a routine colonoscopy as part of their standard clinical care to     objectively confirm active disease and obtain biopsies for microbiome and gene expression.     The investigators will obtain prior authorization from the subject's insurance company for     such colonoscopy, or if it is not covered by the insurance, the investigators will use study     funds to pay for the procedure. They will then be assigned to one of two dietary intervention     arms based on their preference and will meet with the study registered dietician at the MGH     Clinical Research Center (CRC) metabolism and nutrition unit. There, they will receive     instruction on the components of the assigned dietary therapy arm - partial elemental diet     (enteral nutrition) or specific carbohydrate diet, and will complete a baseline food record     (FR). They will adhere to the dietary therapy for 6 weeks after which they can resume normal     diet. Clinical, biochemical, nutritional, and microbiological parameters will be measured     during and for 6 weeks following the study. They will have 5 study visits during this time.   "
66710|NCT02412540|"     The goal of this study is to determine effective treatment and identify diagnostic biomarkers     for Nonalcoholic steatohepatitis (NASH). Individuals that take part in the study will be     participating in either a weight loss surgery (WLS) group or a comprehensive lifestyle     intervention (CLI) group. People in the WLS group will receive vertical sleeve gastrectomy     (VSG). The CLI group will receive dietary, activity and behavioral interventions provided by     trained study staff.   "
66721|NCT02412397|"     To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite     Shoulder System   "
66711|NCT02412527|"     Objective: Computerized sleep staging has been verified in a normal population. This study     attempts to investigate and verify the interpretation of this computerized sleep staging     program in patients with sleep disorders, and improve the accuracy of actigraphy algorithm     for sleep duration and postures.        1. Compare the accuracy of computerized sleep-wake analysis with current sleep quality          indicators: through actigraphy and heart rate sensors, compare the computerized          sleep-wake analysis program with polysomnography, and verify its clinical reliability          and validity in sleep disorder patients.        2. Establish the sleep posture detection system: through three-axis accelerometer, develop          algorithms for position recording and monitoring during sleep, and upgrade its accuracy          according to photography.      Methods: Patients ranged from age 20-50 with primary insomnia, periodic limb movement in     sleep, simple snores, and obstructive sleep apnea will be enrolled in our study. Routine     polysomnography will be applied in sleep center at Chang Gung Memorial Hospital, Taoyuan, as     well as sleep-related questionnaires. At the same time, actigraphy and heart rate sensor     patch will be used for sleep posture detection and further computerized sleep-wake analysis.     Results will be verified the consistency by comparison with sleep-wake analysis from     polysomnographic data and sleep-related questionnaires.   "
66712|NCT02412514|"     This is a phase IV open-label randomized clinical trial that will compare intestinal and     humoral immunity in infants receiving inactivated poliovirus vaccine (IPV) and two or three     doses of bivalent oral poliovirus vaccine (bOPV).   "
66713|NCT02412501|"     The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native     coronary arteries that allows the use of a 2.0 mm diameter stent.   "
66714|NCT02412488|"     The purpose of the RIO 2 International study is to provide clinical and economic evidence to     support moving the LINQ™ insertion procedure outside these traditional locations within the     hospital, referred to as out-of-cathlab.   "
66748|NCT02412046|"     The aim of this study is to correlate the intensity and the duration of a mechanical strain,     applied over the skin of a bedridden paraplegics, with the microvascularization parameters     (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We     want to detect the early stage of irreversible damage for each patient. To achieve this goal,     we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a     pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First     the interface pressure between the patient body and the air mattress is recorded continuously     for 3 hours (= the repositioning patient frequency): we have the pressure over each point of     the patient body in contact with the mattress on this time lap. Then, we will measure the     microvascularization parameters, using an O2C medical device over a trochanter on a specific     anatomical area which will be thereafter biopsied. Finally, depending on the group in which     they were randomly distributed, the patient will undergo a muscle biopsy on his or her     trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be     able to determine the effect of the mechanical strain duration on the physiologic parameters.     The following day, the patient is undergoing his or her surgery for removing the necrotic     area of the bedsore. At the same time, we will recover some of the sample near the bedsore     which would serve as a maximum inflammatory response. Then a second muscle biopsy will be     performed on an innervated area to be able to determine a basal concentration of biomarkers.      The inclusion period for this study will be 3 years. All the patients are followed for 24     hours then they will be followed by medical staff in their bedsore resection setting.      The data gained for this study will hopefully help the scientific world to achieve a better     understanding of the pressure ulcer aetiology. They will also be helpful to achieve a     mobilization of the patient specific of his or her inherent characteristics with a high     sensitivity level. This way we will have a more efficient bedsore prevention.   "
66715|NCT02412475|"     Successful treatment for children and young adults with relapsed acute myeloid leukemia (AML)     continues to be a significant challenge. Despite relative improvements in survival for     patients with newly diagnosed AML, an estimated 40-60% will relapse with the majority     eventually dying of their relapsed disease. Attaining a subsequent remission in patients who     relapse is the initial critical step toward achieving a potential cure. As chemotherapy     resistance is one of the primary drivers of poor treatment response and subsequent relapse in     AML, identifying methods to reverse this resistance are desperately needed. This clinical     trial is aimed at improving the remission re-Induction rates for children and adults with     relapsed or refractory AML through epigenetic modifying agents that have the ability to     reverse chemotherapy resistance. Decitabine, a DNA methyltransferase inhibitor (DNMTi) and     Vorinostat, a histone deacetylase inhibitor (HDACi), are two epigenetic modifying drugs that     act on the methylation of proximal promoter regions of genes and on proteins involved in the     wrapping of DNA around histones, respectively. Both processes play a critical role in     regulating gene expression, and frequently these genes are involved in chemotherapy     resistance. These agents are FDA-approved for treatment in adult hematologic malignancies,     making this an opportune time to begin testing these novel therapies in pediatric leukemia     trials. This study will investigate chemotherapy priming of relapsed/refractory AML using     Decitabine and Vorinostat given for 5 days prior to standard re-Induction with Fludarabine,     Cytarabine and G-CSF for children and adults.   "
66716|NCT02412462|"     This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and     pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a     humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin     (sCLU), a potent inducer of the epithelial-to-mesenchymal transition (EMT). Eligible subjects     will have a disease that has been refractory to prior therapy and is unlikely to benefit from     known therapies.   "
66717|NCT02412449|"     The primary purpose of this study is to compare the PK parameters of a single dose of a test     tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet     formulation, both treatments administered without food, and to compare the PK parameters of     the test tablet formulation given under fed and fasted conditions.   "
66718|NCT02412436|"     This study is being done to evaluate the effect of HIV and TB treatment on a commonly used     birth control method. This study is being done on women who are infected with HIV and TB and     are taking efavirenz (EFV; Sustiva®; an anti-HIV medication), rifampicin (RIF; an anti-TB     medication) and isoniazid (INH; an anti-TB medication). The purpose of this study is to find     out the best schedule to give depot medroxyprogesterone acetate (DMPA; a hormonal birth     control method that is given as a shot every 3 months) in women with HIV and TB who are also     taking EFV and RIF. This study will also try to find out if a 150 mg injection of DMPA is     effective in preventing ovulation, the process by which the ovaries (the ovaries are part of     the female reproductive system) release an egg for fertilization, for 12 weeks in women who     are taking EFV and RIF. Another purpose of this study is to find out if it is safe to take     RIF, EFV and DMPA at the same time.   "
66722|NCT02412384|"     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in     lung cancer could play an important role in diagnosis, predicting the risk for tumor     recurrence, and providing novel target therapy biomarkers. In view of these facts, the     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting     human tumor cells of lung cancer in normal peripheral blood after cryosurgery with or without     dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also     compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)     method.   "
66723|NCT02412371|"     This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination     with concurrent Paclitaxel/Carboplatin-based chemoradiotherapy (Phase 1 portion) and to     assess whether the addition of oral veliparib versus placebo to Paclitaxel/Carboplatin-based     chemoradiotherapy with Paclitaxel/Carboplatin consolidation will improve progression-free     survival (PFS) in subjects with Stage III non-small cell lung cancer (Phase 2 portion).   "
66724|NCT02412358|"     -  Objective: To compare clinical results of three types of manual tooth brushes on          gingivitis and plaque removal efficacy.        -  Material and Methods: This study is a single blind randomized trial with crossover          design which involved 30 periodontally healthy individuals. At baseline professional          plaque removal and oral hygiene instruction are performed for all the students, then          they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores          are measured using plaque and gingival indices (PI and GI). Then subjects are instructed          to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed          again. After passing one-week period for wash out, subjects don't brush for 1-2 days and          indices are recorded again. The same procedure are done for Cross action, and Butler 411          tooth brushes respectively.   "
66725|NCT02412345|"     The primary objective of this study is to determine the impact of the shock wave application     in renal transplant patients with diagnosis of erectile dysfunction. Secondary objectives are     to assess the effects of therapy on quality of life and depression.      It is expected that with the study is defined the usefulness of the therapy and the     dissemination of knowledge generated for change in clinical management in renal transplant     patients with erectile dysfunction.   "
66726|NCT02412332|"     The purpose of this study is to determine whether cell therapy with autologous adult stem     cells (from bone marrow and/or fat) is safe in the treatment of advanced Chronic Obstructive     Pulmonary Disease (COPD).   "
66727|NCT02412319|"     Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in     the treatment of HBeAg positive chronic hepatitis B.   "
66729|NCT02412293|"     There is limited evidence from community-based interventions to guide the development of     effective maternal, perinatal and newborn care practices and services in developing     countries. Investigators planned to evaluate the impact of a low-cost package of     community-based interventions implemented through government sector lady health workers     (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on     perinatal and neonatal outcomes in a sub-population of the remote mountainous district of     Gilgit, Northern Pakistan.      A community-based package for use by LHWs and CHWs geared towards prevention and promotion of     maternal and newborn health practices and services will be developed based on formative     research in the study district. The package will include promotion of antenatal care,     adequate nutrition, skilled delivery and healthy newborn care practices at household level.     The health workers will be trained in recognition of danger sign that warrant referral to     health care service. LHWs and CHWs will delivered the package via community awareness     sessions and two one-to-one counselling sessions to pregnant women during third trimester and     five newborn assessment visits in the neonatal period. In addition to this, community     mobilization activities included formation of CHCs and creation of support for the uptake of     the interventions. Control areas will continue to receive the routine standard health     services of governmental and non-governmental organizations in the area. The intervention     areas will receive the intervention package in addition to the routine standard health     services. Outcome measures will include changes in maternal and newborn-care practices and     perinatal and neonatal mortality rates between the intervention and control areas.   "
66730|NCT02412280|"     Validity of MELD vs MELD XI in assessing 1 year survival after living donor liver     transplantation.   "
66731|NCT02412267|"     The purpose of this study is to determine the efficacy and safety of ofatumomab in     combination with ICE chemotherapy in subjects with relapsed/refractory DLBCL following     failure to combination rituximab and anthracycline based chemotherapy. Participants with the     option of potentially curative stem cell therapy may proceed to high dose chemotherapy and     stem cell rescue. Participants with disease not considered curable with stem cell therapy,     ineligible for or decline stem cell therapy may receive up to a maximum of 6 cycles of study     drugs.   "
66732|NCT02412254|"     The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old     adults with hearing loss to best-practices hearing rehabilitative treatment (hearing     assessment, counseling, fitting of amplification devices) versus a successful aging     intervention (one-on-one counseling/education sessions on successful aging topics).     Participants will be followed for 6 months, and outcomes will focus on communication, quality     of life, cognition, and other functional surveys. This pilot study is in preparation for a     larger planned trial to investigate if hearing loss treatment can reduce cognitive decline     and dementia in older adults.   "
66743|NCT02412111|"     This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group,     multicenter study in subjects aged 12 years and older with CF who are heterozygous for the     F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically     demonstrated to be ivacaftor responsive.   "
66744|NCT02412098|"     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral     dose of eleclazine in participants with normal and impaired hepatic function. Participants in     the healthy control group will be matched to participants with impaired hepatic function by     age (± 5 years), gender, and body mass index (± 10%).   "
67397|NCT02403557|"     The purpose of this study is to determine whether tailored internet-administrated cognitive     behaviour therapy (ICBT) is a feasible approach in the treatment of anxiety symptoms and     comorbid depressive symptoms in older adults.   "
66733|NCT02412241|"     This four-year, prospective, longitudinal study will evaluate and validate a patient-reported     outcome measure, clinician-reported outcome measures, and imaging techniques in assessing     characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity     and oropharyngeal cancer patients.      This clinical trial studies patient-and-clinician-reported measures as well as standard     imaging methods to see how accurate they are in identifying and evaluating lymphedema     (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients     receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer.     Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and     chewing, as well as psychological and emotional symptoms, such as negative body image and     avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow     doctors to treat LEF more quickly and control symptoms more effectively, and thus provide     patients with a better quality of life.   "
66734|NCT02412228|"     The goal of this proposal is to develop a more effective and better tolerated regimen.     Ixazomib appears to have greater activity than bortezomib with less peripheral neuropathy.   "
66735|NCT02412215|"     This study aims to assess the rotational stability of the new collameric Nanoflex toric     intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.      The purpose of this study is also to determine whether the use of a toric intraocular lens     (T-IOL) improves visual acuity.   "
66736|NCT02412202|"     Switching from positive airway pressure ventilation to spontaneous ventilation during weaning     from mechanical ventilation, pulmonary edema may occur and in this case, doppler     echocardiographic (U/S) indices of cardiac dysfunction correlates with the concentration of     fluid in interstitial space.      Forty consecutive mechanically ventilated critical ill patients who fulfill criteria for     weaning from mechanical ventilation, will be included in this study. All patients will be     evaluated daily and when the patients fulfill weaning criteria them they will undergo a     2-hour spontaneous breathing trial (SBT) through a T-piece.      Before and after SBT cardiopulmonary function will be assessed by thermodilution and     echocardiography. In patients with preserved LV systolic function, an echocardiographic index     of diastolic dysfunction (E/Em ratio) before preforming SBT may identify high risk patients     for increasing extravascular water in weaning.      In addition, the investigators expect to find positive correlations (p<0.05) between     pulmonary extravascular lung water and echocardiographic indices (such as E/Em ratio) during     SBT.   "
66737|NCT02412189|"     The arterial blood pressure affects the ratio between filtration and reabsorption of fluids     in the circulating blood volume and thereby the hematocrit. During induction of anesthesia     blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to     evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction     reduces the decrease in hematocrit.   "
66749|NCT02412033|"     Intrauterine devices (IUDs) are widely used as reversible contraceptives. Both copper- and     levonorgestrel (LNG)-releasing IUDs (LNG-IUDs) are safe,cost-effective in the long term and     equally effective compared with tubal sterilization.      In addition, the LNG-IUD (Mirena®) provides non contraceptive benefits, such as treatment for     menorrhagia, dysmenorrhea and anemia. The current use of IUDs among reproductive-aged women     ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8%     insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and     5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women     who have never delivered vaginally.      Cervical stenosis, an immature or small cervix and a significantly ante- or retroverted     position of the uterus, has been described as factors associated with a difficult sounding of     the cervical canal or even failure to insert the IUD.      Misoprostol is an inexpensive prostaglandin E1-analogue, which is associated with few side     effect. More over several have shown the benefit of misoprostol as a cervical ripening agent     in non pregnant women. Priming with misoprostol prior to hysteroscopy and dilatation and     curettage (D&C) in perimenopausal women resulted in increased cervical dilatation and lower     rate of cervical laceration.      The effect of misoprostol on the cellular matrix causes dissolution of collagen fiber     increasing the amount of fluid in the stroma and consequentially causes cervical effacement.     Fear of pain during insertion, however, might prevent some women from choosing IUD and fears     of painful and/or difficult placements may lead them to recommend or counsel women on other,     less effective methods.      Women's perception of pain is multifactorial and likely to be influenced by cultural     differences and personal experiences; insertion-related pain is therefore difficult to     predict. Nevertheless, factors associated with greater pain include nulliparity, not     currently breastfeeding and longer time since last pregnancy; of these factors, nulliparity     is the strongest predictor of pain.      The proportion of women of reproductive age who are nulliparous is increasing, with women     delaying childbirth and having fewer children or choosing to remain childless. The proportion     of Caesarean section births has also increased and women who have only ever had a Caesarean     section are often viewed as nulliparous with respect to IUD placement. Anticipated pain is     often greater than the actual pain experienced, and the majority of nulliparous women     experience no more than moderate pain during IUD insertion. However, among nulliparous women     there is a subset (about 17%) for whom the insertion of IUD is associated with severe     pain.These women need effective pain relief.      For most nulliparous, nulligravid or parous women, IUD insertion can be performed     successfully without cervical priming and with a minimum amount of discomfort. Whether     selective use of misoprostol has a role in management of pain in certain subsets of women     (e.g. nulliparous women and those in whom the insertion is non-routine/difficult) has yet to     be adequately studied.   "
66750|NCT02412020|"     This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study in     adult patients with refractory chronic cough.      The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via     eFlow high efficiency nebulizer for treating refractory chronic cough.   "
66755|NCT02411955|"     The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene     Cream 0.1% and Tazorac® (tazarotene cream 0.1%).   "
66756|NCT02411942|"     The objectives of this study are to evaluate the therapeutic equivalence and safety of     Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).   "
66738|NCT02412176|"     Background Right ventricular (RV) artificial apical pacing can negatively impact synchrony of     left ventricular contraction. The pacing from the septum of the RV can present an advantage     in terms of less expressed dyssynchrony and reduced negative impact on left ventricular (LV)     function. However, results of randomized studies comparing apical and septal pacing are not     uniform. All these results have been affected by improper implantation of the septal lead,     with many apparently septal leads being, in fact, implanted off-septum. The aim of the study     is to compare true septal pacing with other RV pacing locations.      Methods/Design This is a prospective, randomized, single center study. Patients with standard     indications for cardiac pacing with the expectation of high percentage RV pacing will be     enrolled. They will be randomized into apical and septal pacing. The real location of leads     in patients randomized to septal pacing will be confirmed using cardiac CT. After cardiac CT,     three groups of patients will be created: 1) apical pacing, 2) true septal (in which the     position of the lead has been verified to be in the septum), and 3) apparent septal (in which     the position of the lead was found to be off-septum). Primary end-point are changes in     standard echocardiographic parameters (LV ejection fraction, LV end-systolic volume, and LV     end-diastolic volume) and the concentration of N-terminal pro brain natriuretic peptide     (NT-proBNP) from baseline to 6 months, 1 year and three years. Secondary end-points are     changes in echo-parameters of LV synchrony.      Discussion It is hypothesized that correct septal pacing will be associated with reduce     negative impact on the function of the left ventricle (i.e. smaller decreases in LV EF and     smaller increases in LVEDV, LVESV) and NT-proBNP, and less expressed LV dyssynchrony.   "
66740|NCT02412150|"     The purpose of the present study was to compare the effect of dexmedetomidine which is     administered during emergence in adult patients undergoing elective thyroidectomy on smooth     emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or     tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital     staying).   "
66741|NCT02412137|"     To measure the effectiveness of counseling on brace-wear compliance and curve progression in     patients with adolescent idiopathic scoliosis. The investigators hypothesize that compliance     is increased when it is measured and used to counsel patients, and therefore those patients     will have less curve progression and fewer would need surgery.      A second purpose is to evaluate whether there is a correlation between BMI and brace     effectiveness. Proposed theories for decreased effectiveness in patients with elevated BMI     have included decreased compliance due to discomfort and decreased force exerted on the curve     due to the larger habitus.   "
66742|NCT02412124|"     This pilot clinical trial studies a peer-to-peer support program in improving quality of life     outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and     mentoring may help improve quality of life and reduce symptoms of distress in gynecologic     cancer patients and their families.   "
66745|NCT02412085|"     This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid     dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive     subcutaneous golimumab treatment, according to EU marketing authorization from baseline     through week 14.      At week 16, patients achieving clinical and endoscopic remission will continue with     Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.      Patients not achieving clinical and endoscopic remission will be treated with infliximab,     according to marketing authorization, and followed through week 52. This is not considered as     an interventional arm but, since infliximab in Italy is considered as the first-line     treatment for UC patients, as the usual clinical practice.   "
66746|NCT02412072|"     A prospective multicenter trial has been started in Korea to evaluate the diagnostic accuracy     of endometrial aspiration biopsy compared with D&C in patients treated with progestin for     endometrial hyperplasia (EH). For conservative treatment of EH, oral progestins are most     commonly used method with various treatment regimens and more recently, the     levonorgestrel-releasing intrauterine system (LNG-IUS) also has been used successfully to     treat EH. However, there is no report about the accuracy of endometrial sampling during     hormonal treatment for follow-up evaluation of EH. Patients with histologically confirmed EH     are offered hormonal treatment, one of the following 3 options: oral medroxyprogesterone     acetate(MPA) 10mg/day for 14days per cycle, continuous oral MPA 10mg/day, or insertion of     LNG-IUS. Histological surveillance is performed at 3-months or 6-months following initial     treatment. Endometrial tissues are obtained via endometrial aspiration biopsy using a pipelle     and D&C. In case of using LNG-IUS, endometrial aspiration biopsy will be done with LNG-IUS in     uterus and then, after removal of LNG-IUS, D&C will be done. The biopsy findings will be     compared. The primary endpoint is the consistency of the results of the endometrial     aspiration biopsy and D&C. The secondary endpoint is the response rate with 3 types of     progestin treatment at 6 months.   "
66747|NCT02412059|"     In this prospective randomized controlled double blind pilot clinical study, we aim to assess     whether administration of a topical corticosteroid would attenuate epiretinal membrane     formation following development of retinal tears treated with laser retionpexy.   "
66751|NCT02412007|"     Activity based therapy is gaining interest for rehabilitation of children with cerebral palsy     (CP). A home-based comprehensive programme structured on the principles of activity based     therapy seems to hold promise in the field of rehabilitation of children with diplegic     CP.This may reduce morbidity as well as promote better quality of life in these children . In     this backdrop our study has been planned with an aim to evaluate the efficacy of a     comprehensive home-centred activity based programme for children with diplegic CP.   "
66758|NCT02411916|"     This document defines the Clinical Investigation Protocol for a study designed to determine     whether blood loss after spontaneous vaginal delivery is altered by the addition of     misoprostol administration to the standard use of intravenous oxytocin after delivery. The     protocol is an open-label randomized prospective trial to be carried out at Queens Hospital     Center.      Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit     levels on admission in labor to those obtained within 24 hours after delivery.   "
66759|NCT02411903|"     The investigators team had found that the presence of dynamic changes of Clopidogrel     resistance are not associated with genetic factors. Currently, study on moderate doses of     statins and dynamic Clopidogrel resistance has not been reported, therefore this study will     observe 160 cases of open prospective secondary prevention in patients with cerebral     infarction. Excluded: those patients occurs Clopidogrel resistance because of slow metabolism     caused by cytochrome P450 isoenzyme 2C19（CYP2C19, and then observed the impact of the     cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized and non-cytochrome P450 isoenzyme 3A4     （CYP3A4）—metabolized statins dynamically on Clopidogrel resistance in the next 9 months,     adverse events will be recorded, the metabolite of clopidogrel（H4 ）and the polymorphism of     cytochrome P450 isoenzyme 2C19 （CYP2C19）/cytochrome P450 isoenzyme 3A4 （CYP3A4）/ cytochrome     P450 isoenzyme 2C9（CYP2C9）will be detected. Expected Result: the patients use the cytochrome     P450 isoenzyme 3A4（CYP3A4）-metabolized statins will result in dynamic Clopidogrel resistance     easily ,H4 levels will decline, and Clopidogrel resistance is not related to the polymorphism     of cytochrome P450 isoenzyme 3A4 （CYP3A4）.   "
66760|NCT02411890|"     The aim of this study is to compare the efficacy in pain relief within 24 hours between     adductor canal block and femoral nerve block after anterior cruciate ligament reconstruction     with hamstring graft.   "
66761|NCT02411877|"     The purpose of this study is to determine whether reducing a patient's body temperature (mild     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury     (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a     significant interruption of blood flow to an area of brain (occlusion of large proximal     cerebral artery) and have undergone successful removal of that interruption     (revascularization).This will be achieved by comparing patients who have undergone     hypothermia to those who have not.   "
66762|NCT02411864|"     Our research aims to reveal whether the low b-values distribution and the number of NEX for     each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in     brain.   "
66763|NCT02411851|"     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some     consider it as an incipient squamous cell carcinoma (SCC). Ingenol mebutate is the active     compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment     has been approved for the treatment of AKs. Ingenol mebutate gel 0.015% has shown to not only     have a high clearance rate but also a transient localized inflammatory skin response that     resolves quickly without sequelae. However, these localized skin responses (eg erythema,     erosion/ulceration, edema, etc.) can often be unpleasant and unsightly. Currently, there are     no clinical studies evaluating combination therapies (eg topical steroids, emollients) with     ingenol mebutate 0.015% that would decrease irritation and improve wound healing while     maintaining efficacy.   "
67186|NCT02406326|"     This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10     patients per centre involving approximately 25 centres). Patients will be followed up     clinically for twelve months post-procedure at 1 month, 6 months & 12 months. All patients     will have a repeat angiography at 8 months. Clinical follow-up will be maintained for years 3     & 5 post-implant.   "
66764|NCT02411838|"     The investigators hypothesize that adipokine (soluble molecules produced by the adipose     tissue) levels are altered in MS compared to control subjects. Additionally, the     investigators hypothesize that calorie restriction (CR) will improve clinical recovery from     an MS relapse, ameliorate the adipokine and metabolic-inflammatory profile in MS, and enhance     immune-regulatory mechanisms.      This is a pilot study to determine the effects of CR in MS patients during an acute MS     relapse (Acute CR phase) and for 6 months afterwards (Chronic CR phase). Calorie restriction     will be achieved by following a regimen of alternate day fasting. The investigators will     evaluate clinical outcomes and blood biomarkers at different time points.   "
66765|NCT02411825|"     Primary Objective:      To assess in healthy adult male subjects:        -  The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899          including two up titration steps.        -  Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in          plasma.        -  Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin,          biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21).      To assess in overweight to obese T2DM mellitus patients:        -  The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up          titration steps.        -  PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine.        -  PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin          panel (total and active ghrelin, total peptide YY [PYY], total and active glucagon-like          peptide -1 [GLP-1], glucagon and total gastric inhibitory polypeptide-1 [GIP]), body          weight, FGF21, biomarkers of lipid metabolism and HbA1c.   "
66766|NCT02411812|"     The purpose of this study is to determine if the Herbst appliance with indirect skeletal     anchorage in mini-implants is capable of preventing excessive inclination of the lower     incisors at the end of the treatment when compared to the Herbst appliance with dental     anchorage in patients with Class II malocclusion and overjet ≥ 6 mm.   "
66767|NCT02411799|"     Establish a data repository of patients who have undergone thoracic and/or lumbar     instrumented arthrodesis procedure supplemented by the Implanet Jazz System.   "
66768|NCT02411786|"     The purpose of this study is to determine if a vaccine called pTVG-AR can enhance patients'     immune response against prostate cancer.   "
66769|NCT02411773|"     The purpose of this study is to find out why patients with chronic kidney disease (CKD) have     poor exercise capacity and what causes an increase in blood pressure during exercise (i.e.     increased adrenaline levels, or decreased ability of blood vessels to dilate).   "
66770|NCT02411760|"     In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS     MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score,     which utilizes both DWI and DCE data. The sensitivity and specificity of each approach will     be determined using pathology as the gold standard.   "
66771|NCT02411747|"     Simulation training in surgical education in Urology specialist training in flexible     cystoscopy has been demonstrated a valid and efficient learning instrument. The classical     setup with a medical expert introducing the novices to the theoretical background and     technics of the procedure is time-consuming and expensive. Directed self-regulated simulation     training (DSR) is a validated method in simulation training. The power of testing in DSR and     flexible cystoscopy is to our knowledge not known. We introduced a setup in which the novices     started by training in a directed self-regulated simulation training environment and informed     them that they would be tested by a medical expert afterwards. The intervention group novices     were given only written theoretical information and anatomical pictures. The control group     were first given a classical oral theoretical introduction by a medical expert and secondly     did DSR training. We tested the outcome of the intervention by a validated rating scale for     flexible cystoscopy. The novices in both the control and intervention group were tested on     patients prescribed a flexible cystoscopy and evaluated by a specialist in Urology.      The main hypothesis was that testing in relation to DSR would result in higher scores on a     validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist     in Urology compared to a group having a oral lecture before DSR.   "
66772|NCT02411734|"     Executive function will be tested in patients admitted for rehabilitation and correlated with     rehabilitation success   "
66773|NCT02411721|"     Studies have shown that about two thirds of the children undergoing MRI suffer from feelings     of anxiety ranging from mild apprehension to severe distress. Especially in young children,     the unfamiliar surroundings, new faces, strange equipment and the noise generated during the     scan, can cause feelings of stress and anxiety so severe that the test either cannot be     started or cannot be performed properly due to the child's movements. For older children and     adults claustrophobia is the main reason of poor image quality because of motion artifacts     and/or early termination of the scan. Several studies have demonstrated the potential calming     effects of companion animals on children but, to date, no formal studies on the relationship     between dog intervention and children's anxiety before MRI procedures have been reported. The     current study is designed to determine if dog intervention lessens children's anxiety prior     to MRI   "
66774|NCT02411708|"     Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive     crisis   "
66775|NCT02411695|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of     oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric     Disorders.   "
66776|NCT02411682|"     Reduction of postprandial hyperglycemia (PPHG) is a major target in the treatment of type 2     diabetes (T2D). Skipping breakfast has been consistently associated with higher HbA1c and     overall PPHG in subjects with type 2 diabetes (T2D). Our aim was to explore the effect of     skipping vs eating breakfast on PPHG after subsequent isocaloric (700kcal) lunch and dinner   "
66808|NCT02411266|"     In remote preconditioning, ischemia in one organ protects distant organs from ischemic     insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe     stroke. The investigators propose a study of limb preconditioning in subjects with     subarachnoid hemorrhage who are at high risk of cerebral ischemia in the first 2 weeks after     hemorrhage. The investigators have previously shown that 3x 10min leg conditioning cycles are     tolerated and appear safe. The investigators are now continuing to assess the safety of the     intervention by enrolling an additional 60 patients.   "
66777|NCT02411669|"     A national context for patient centered care development exists in France at hospital with     strong support for the implementation of operational patient centered care tools. Patient     centered care is a global vision of patient or family management promoting the respect of     patient freedom, of patient listening and of patient needs. Patient centered care is an     important issue of quality and security of care. The FORAP (Fédération des Organismes     Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la     HAS (High Authority of Health) have developed and validated five tools promoting patient     centered care at hospital.      They can be implemented one by one or in association according to hospital situation.     Hospitals should identify the association of tools fitting the most to their objectives and     the actions already done.      The objectives of the project are to analyse the effectiveness of the implementation of HAS -     FORAP tools on the development of patient centred care at hospital and to analyse the     individual and organisational determinants of their effectiveness. It focuses on acute care     hospitals that have the choice of the combination of tools and that are followed during two     years with combined quantitative and qualitative analyses. Quantitative assessment are based     on validated indicators on patient satisfaction, patient centred care development and     organizational context. Qualitative data collection are realised in each included hospital     and combine individual interviews and focus groups including Physicians, nurses and     managerial staff.   "
66778|NCT02411656|"     You are being asked to take part in this study because you have inflammatory breast cancer     (IBC) or triple negative breast cancer (TNBC) that is metastatic (has spread to other parts     of the body).      The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475     and Keytruda) can help to control metastatic IBC and TNBC. The safety of this drug will also     be studied.   "
66779|NCT02411643|"     This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene     ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea     lesions before and after treatment with topical calcipotriene 0.005% ointment will be     analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be     obtained and used for a control. This is an initial study to look at the molecular effects of     topical calcipotriene on human morphea-involved skin. This study will look at the differences     between affected and unaffected skin. This study also will look at clinical outcomes in     morphea patients and determine if there are any clinical predictors for improvement with the     medication.   "
66780|NCT02411630|"     The purpose of this study is to test a new way to take a questionnaire that asks about     adherence (whether the person is taking the medicine correctly). This new questionnaire is     called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on     HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another     study, either ATN 110 or ATN 113.   "
66781|NCT02411617|"     Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage     is used routinely to reduce incidence of seroma. Usually two drains are used in patients who     underwent MRM to reduce post operative seroma. It is often associated with significant     patient discomfort and prolonged fluid drainage.      The aim of this study is to evaluate effect of number of drains on seroma formation rate,     postoperative pain and hospital stay during the immediate postoperative period after     mastectomy for breast cancer.   "
66782|NCT02411604|"     Open label, multi-center, expanded access study for renal transplant patients with once daily     Envarsus XR (Tacrolimus).   "
66792|NCT02411474|"     Investigate the profiles of tear cytokines in patients who underwent stem cell     transplantation (SCT) and attempted to determine the applicability of tear cytokines in the     diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers     of chronic ocular GVHD severity.   "
66793|NCT02411461|"     Pseudohypoparathyroidism type 1a (PHP1a) is a rare disease that causes childhood obesity and     learning difficulties. This study will investigate eating behaviors and perform cognitive     testing on children with PHP1a. The investigators will compare their results to those of     healthy siblings and other obese children.   "
66794|NCT02411448|"     The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in     combination with erlotinib as compared to placebo in combination with erlotinib in     participants with stage IV non small cell lung cancer (NSCLC) harboring an activating     epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability     of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A)     before proceeding to the second portion of this study (Part B).   "
66795|NCT02411435|"     CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment     and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for     treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer     of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4     (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between     CAB and RIF is possible. This study will be a phase I, single-center, open label,     fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg)     when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg     administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable     subjects for this study.   "
66796|NCT02411422|"     The investigators will compare conventional intubation using Macintosh laryngoscope, blind     endotracheal intubation using i-gel for conduit and bronchoscopic intubation using     Ambu-aScope and i-gel. All situation assumed as cardiac arrest. i.e, someone give chest     compressions continuously without interruption.      Moreover the investigators will compare the type of endotracheal tube. Reinforced tube has     more soft tube tip, so the investigators think it is more acceptable for intubation using     i-gel as conduit.   "
66809|NCT02411253|"     Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells,     leading to an absolute deficiency in insulin.      In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and     likewise prevent autoimmune diseases. Tregs are insufficient in T1D.      The investigators previously showed that administration of low doses of IL-2 induces     selective expansion and activation of Tregs in mice and humans.      The investigators hypothesize that Tregs expansion and activation with low doses of IL2 could     block the ongoing autoimmune destruction of insulin producing cells in patients with recently     diagnosed T1D.   "
66797|NCT02411409|"     The CommunityRx system generates patient-centered e-prescriptions for community services     (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive     community resource database. Based on a patient's diagnoses, a HealtheRx will be printed     automatically at the end of the ambulatory care visit and will provide patients with a     customized map and/or list of places in their community that provide health and social     services as well as contact information for a local community health worker who can provide     limited case management support. The CommunityRx program aims to promote: 1) better     healthcare, 2) better health, and 3) lower cost. The purpose of this research is to     systematically evaluate the impact of CommunityRx on health outcomes as well as health care     service utilization and total cost of care for Medicaid, Medicare and other beneficiaries.     The investigators hypothesize that beneficiaries who participate in the CommunityRx     intervention will experience better healthcare, better health and lower total cost of care.   "
66798|NCT02411396|"     The Emergency Department has been the standard location where patients with Sickle Cell     Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive     Crisis (VOC) is the most common complication of SCD,      The purpose of this study is to compare patient centered outcomes for patients being treated     for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four     locations around the United States.   "
66799|NCT02411383|"     This study is a prospective, single-center feasibility study to acquire more knowledge     regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with     this system during the weaning period from mechanical ventilation in the Intensive Care Unit     in patients after bilateral lung transplant.   "
66800|NCT02411370|"     Communication is essential for patients quality of life because it impact on patients care     quality. Neuromuscular diseases, caracterised by motor damages, hinder non-verbal     communication of the patient. Therefore, speech must to be functional.      However, correlation between respiratory failure and voice quality is not very well known.     The aim of the study is to search a link between respiratory failure and speech impairment in     patients with neuromuscular diseases.   "
66801|NCT02411357|"     Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was     unintended and the majority of non-pregnant opioid-maintained women do not use contraception     or use less effective methods like condoms. This proposal aims to further test a novel     contraceptive management program to increase use of more effective contraceptives among     opioid-maintained women at risk of unintended pregnancy.   "
66802|NCT02411344|"     The purpose of this study is to evaluate the activity of molecular response in endocrine     sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus     Ietrozole.   "
66803|NCT02411331|"     Implantable venous access port infections are mainly due to coagulase negative staphylococci     and may be managed by antibiotic lock therapy with retention of the port. Most of the time a     vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in     eradicating the staphylococcal biofilm in the port. Another disadvantage of     Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of     catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does     not expose to the risk of emergence resistance.   "
66804|NCT02411318|"     This study will determine how common lifestyle practices affect the behavior of neutrophils     (a type of immune cell) at shorter time scales than previously possible.   "
66805|NCT02411305|"     Few formal mechanisms for collecting, analyzing, and reporting data on quality in palliative     care exist. Such infrastructure is needed to understand current clinical practices, inform     quality improvement projects, and research which links adherence to specific quality measures     and improved patient-centered outcomes. This infrastructure, if proven feasible, can then     become integrated into usual palliative care delivery across the PCRC. Then, palliative care     can conduct the same types of collaborative quality improvement activities, based on data     collected at point of care, as other medical disciplines like general surgery and cardiology.   "
66806|NCT02411292|"     Venous thromboembolism (VTE) is a leading cause of death among hospitalized patients, and is     an important patient safety issue in plastic surgery. Previous work in plastic surgery has     shown that enoxaparin prophylaxis can prevent many post-operative VTE events, and current     American Society of Plastic Surgeons guidelines support enoxaparin prophylaxis for high-risk     patients. However, the Plastic Surgery Foundation-funded Venous Thromboembolism Prevention     Study showed that one in 25 highest risk patients still had a breakthrough VTE event     despite receipt of guideline-compliant enoxaparin prophylaxis. Highest risk patients often     have cancer or trauma reconstruction. These surgeries may have surgical injury that is equal     in scope to patients with traumatic or thermal injury. Previous work in patients with     traumatic or thermal injury has shown that enoxaparin metabolism, measured by anti-factor Xa     (aFXa) level, is substantially increased: a higher degree of injury is associated with higher     enoxaparin dose requirements to achieve prophylactic levels. Breakthrough VTE events may     occur in plastic and reconstructive surgery patients due to inadequate enoxaparin dosing. The     investigators will examine enoxaparin pharmacokinetics and will test whether a clinical     protocol for real-time enoxaparin dose adjustment can favorably alter the proportion of     patients with in-range aFXa levels. Primary outcomes will include 1) peak and trough     steady-state aFXa levels in response to standard and escalated doses of enoxaparin and 2) the     proportion of patients with appropriate aFXa levels before and after initiation of a clinical     protocol for enoxaparin dose adjustment. The investigators expect that standard dosing will     result in inadequate aFXa peak and trough levels, and that the clinical dose adjustment     protocol will significantly improve the proportion of in-range aFXa levels. The investigators     will also develop a linear regression-based equation to calculate, based on patient-level     factors, the required dose of enoxaparin to generate in-range aFXa levels. This research may     show that the current one size fits all approach to enoxaparin prophylaxis is insufficient.     In the trauma and orthopaedic populations, patients with low initial aFXa levels are     significantly more likely to develop DVT. Thus, this research has important implications for     appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the     substantial morbidity and mortality associated with post-operative VTE.   "
66807|NCT02411279|"     Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can     be prevented by early action. The management of HF is complex: long, often difficult and     costly. In France, nearly one million people suffer from HF and 120,000 new cases are     diagnosed every year. With the aging population, this number will continue to evolve and     become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart     failure in either the 3 most common diseases in industrialized countries.      The objective of the project is to test an intelligent platform for monitoring at home, using     non-intrusive sensors, patients with heart failure, particularly those with stage II and III     NYHA. It will assist the medical automating the processing of information from these sensors     to detect and report an early stage risk situations.      Patient monitoring, by a system of telemedicine tools associated with motivation and     education helps significantly reduce the number of days of hospitalization becomes important     when the patient is hospitalized for acute HF.   "
66810|NCT02411240|"     Short-term and chronic exposure to ambient levels of particulate matter (PM) is associated     with increased morbidity and mortality related to respiratory and cardiovascular disease.     Proposed biological pathways imply that particle-induced inflammation plays a role in     activating the vascular endothelium and altering vascular function. Accumulating evidence     suggests that outdoor air pollution has a significant impact on central nervous system health     and disease and living in conditions with elevated air pollution has been linked to decreased     cognitive function.      Only recently was shown that reductions in ambient levels of PM2.5 were associated with     improvements in life expectancy. However, studies of the beneficial effects of improved     indoor air quality on healthy humans are lacking.      With this project the investigators intend to study the effects of rooms with clean air in     the elderly with the emphasis on cardiovascular and cognitive function. The investigators     hypothesise that by means of air cleaning, controlled and reduced exposure has a positive     effect on cardiovascular parameters such as blood pressure, heart rate variability, macro-     and microcirculation and on neurobehavioral function. The investigators substantiate these     outcomes with potential mechanisms of action at the transcript and epigenetic level as with     hematological parameters, markers of inflammation, lipid and protein oxidation products and     mitochondrial DNA damage. To achieve these goals there is a specific need to study the     elderly, as they appear to have elevated susceptibility and have the largest attributable     risk related to indoor PM, as they spend more time indoors. Suited concepts for study     location are elderly homes (service flats) and retirement homes.      The ELiFA-cohort stands for Elderly Living in Filtered Air consisting of an intervention     study during 2-week periods of a pre-purification (baseline), active purification and a post     purification period.   "
66811|NCT02411227|"     Background:      - People with traumatic brain injury (TBI) can have problems with thinking and everyday     activities. They may have a higher risk for car accidents. NeuroDRIVE uses a virtual reality     driving simulator. Researchers think it can help test and improve how people think and drive     after TBI.      Objective:      - To test how NeuroDRIVE affects brain performance and driving safety.      Eligibility:      - People at least 18 years old with a history of TBI and who had a driver s license at some     point. They must speak, read, and write English and be physically able to drive.      Design:        -  Participants will be asked to release their driving records, but they do not have to do          this to be in the study.        -  Visit 1: Screening physical exam.        -  Visit 2: Magnetic resonance imaging (MRI) scan. Participants will lie on a table that          slides into a cylinder with a strong magnetic field. A device will be placed over the          head. Participants may do computer tasks during the scan.        -  Participants will have tests of memory, attention, and thinking. They may be asked          questions, take tests, and do simple actions.        -  Visit 3: Tests of memory, attention, and thinking, plus a virtual reality driving          assessment.        -  Participants will be assigned to Group 1 to start NeuroDRIVE training immediately or          Group 2 to start 10 weeks later.        -  Visits 4 9, over 4 weeks:        -  Participants will practice driving skills and mental exercises in the simulator.        -  They will complete a driving questionnaire online each week.        -  Visit 10: Repeat of Visit 3, with some small changes.        -  Visits 11-12: Very similar to Visits 1-2. Includes MRI scan; physical exam;          questionnaires; and tests of thinking, memory, and attention..        -  After Visit 12: Participants will fill out a weekly driving survey online for 4 weeks.   "
66812|NCT02411214|"     The survey analyses how to improve the decision-making process for fertility preservation in     the pediatric population based on        1. patient and parent feelings about fertility preservation counselling        2. influence of the emotional state of patients and parents on fertility preservation          acceptance        3. support of medical staff and family The study revealed that attention to the fertility          preservation pathways was important for the satisfaction of patient's and parent's          expectations   "
67102|NCT02407431|"     The purpose of the PaTH Network IPF Clinician-Patient Partnership Cohort is to use clinical     data from electronic health records (EHR) and patient reported outcomes (PRO) to answer     questions of clinical importance to patients with Idiopathic Pulmonary Fibrosis, providers,     and other stakeholders.   "
66813|NCT02411201|"     The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of     children aged less than 2 years thanks to several blood samples (3 ml in total) taken     following the administration of DOTAREM®.      DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging     (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged     less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may     take part in the study. In this case they will receive DOTAREM®, a solution injected at the     standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.   "
66814|NCT02411188|"     The goal of the proposed project is to determine if providing an intervention for women who     decline the invitation to participate in standard cardiac rehabilitation programs (CRPs) will     ultimately result in an increase their participation in CRPs.This study will evaluate     outcomes of patients randomized to the FHHS STEP Program versus by non-STEP Program     participants. The overall goal is to provide an alternate, introductory program that will     engage, educate, and empower women following a cardiac event. Providing these women with the     necessary personal resources will encourage and enable these women to take the step towards a     cardiac rehabilitation program, which, in turn will ideally lead to a life-long commitment to     heart health.   "
66815|NCT02411175|"     Constipation is an umbrella term encompassing either infrequent bowel movements, difficult     evacuation of stool, hard stool or a sensation of incomplete defecation. It affects 10-15% of     the global population. Constipation may negatively impact physical health, moods and social     life. There exists a 50% dissatisfaction with traditional approach of laxative use.     Conventional laxatives only offer a temporary solution and may cause dependency. Side-effects     of conventional laxatives include nausea, vomiting, flatulence, diarrhoea, abdominal pain,     electrolyte imbalance and skin eruptions. Homeopathy is a potential treatment option for     constipation, however further research is needed in this regard.      The aim of this study is to determine the efficacy of individualised homeopathic treatment on     constipation using case studies, an adapted Bowel Function Diary and the Bristol Stool Form     Scale.   "
66816|NCT02411162|"     This will be an open-label, non-randomized, single-center study to assess the residency of     GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The     study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will     assess the residence time in human skin . The primary objective is to evaluate the residency     time in skin following topical application of two formulations of GSK2894512 Cream. The total     study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of     post treatment period and 1 day of follow up. The screening period will be up to 28 days     prior to Baseline (Day 1).   "
66817|NCT02411149|"     This study aims to compare the functional recovery of patients undergoing Total Knee     Arthroplasty based on the administration of an adductor canal block during their anesthesia     treatment   "
66818|NCT02411136|"     This study is to evaluate the safety of AMG 623 in subjects with systemic lupus     erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period,     and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.   "
67398|NCT02403544|"     This is a phase I study to evaluate the safety of concurrent chemoradiation combining     radiotherapy (IGRT) with two cytotoxic agents, capecitabine and oxaliplatin in patients with     advanced or inoperable hepatocellular carcinoma.   "
66819|NCT02411123|"     The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on     clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as     depression and anxiety, as compared to a group of subjects with the same attributes without     the guidance of PGx testing for their treatment.      This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug     events, hospitalization rates, hospital length of stay, emergency room visits, disability,     death or other serious drug side effects.   "
66820|NCT02411110|"     This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder     pain syndrome.   "
66821|NCT02411097|"     To investigate whether preemptive analgesic of femoral nerve block could prevent deep venous     thromboembolism due to inhibiting the excessive release of neutrophil elastase and     inflammatory cytokines.   "
66822|NCT02411084|"     The objectives of this study are to determine the efficacy and safety of BEGEDINA® in     subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and     complex immunological disease occurring in some recipients of allogeneic hematopoietic stem     cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI)     tissues. The disease is life threatening and may be acute or chronic and the first choice     treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive     corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to     this treatment leading to disease progression and a high rate of morbidity and mortality,     primarily from infections and/or multi-organ failure. There are currently no other     satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and     binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells     and inhibits the immune response leading to improvement in patients that have shown steroid     resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and     effective treatment for steroid-resistant GvHD patients where no other such treatments are     currently available.   "
66823|NCT02411071|"     Retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy in     Essen (Germany) from 2004 on. Stored samples from selected patients (n=50) obtained for     routine diagnostics will be used to analyze the gag gene, the V3-region of the env gene and     immune cells.   "
66824|NCT02411058|"     In this experiment, the investigators will test the effectiveness of a two week 20x incentive     multiplier on the investigators' corporate partner's users who are (a) not notified about the     incentives in advance, and (b) notified about the incentives and their purpose. The     investigators will test which group shows the largest boost in walking during the two week     intervention and the most lasting behavior change.   "
66825|NCT02411045|"     In this study, the investigators ask the question: can incentivizing smaller, less costly     behaviors—like just getting yourself dressed to go to the gym—be more effective (and     palatable) than incentivizing the larger goal directly?   "
67413|NCT02403349|"     Confirm central blood pressure reduction effect of Fimasartan, Valsartan and Atenolol and     compare correlation with the measured peripheral (central blood pressure, pulse wave     velocity, and flow-mediated dilation) and cerebral blood flow factors (transcranial doppler     findings, cerebral blood flow volume) in acute ischemic stroke patients with hypertension.   "
66826|NCT02411032|"     The investigators are proposing an experiment to help Humana investigate when to launch     programs or send messages that are designed to improve customers' engagement. The     investigators' past research has shown that certain life events and calendar events (e.g., a     job change, a birthday, a holiday, Monday) feel like a fresh start to people and have the     potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a     diet, quitting smoking).   "
66827|NCT02411019|"     This study is to follow up on the change of immune response by measuring HPV type 16/18 E6     and E7 specific T cell response and lesion condition in subjects who have administered in     DNA-based therapeutic vaccine.   "
66828|NCT02411006|"     The investigators seek to increase medication adherence of subjects. The investigators will     send mailings to customers of an insurance company, asking them to predict or commit to a     certain level of behavior. The investigators will measure whether this increases medication     adherence.   "
66829|NCT02410993|"     According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was     recommended for three-vessel coronary artery disease and left main coronary artery disease in     the patients with stable ischemic heart disease as class I. 2-VD with proximal left anterior     descending artery stenosis was also indicated for CABG surgery as class I recommendation.     However, many patients have been recommended for PCI by catheterization laboratory     cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI candidates,     retrospectively, defined by previous ACC/AHA guideline. Although the discordance between real     practice in catheterization laboratory and guideline would be adjusted by recently updated     guideline. The revascularization strategy for patients with 3-VD/LMD in real practice have     been getting toward more PCI and less CABG surgery. In this study, we will identify the rate     of CABG candidates who were treated with PCI or medical treatment instead of CABG surgery in     different from current guideline. We are also going to compare two treatment strategies CABG     surgery vs. PCI with 2nd generation DES regarding clinical outcomes.   "
66830|NCT02410980|"     The researchers will assess the effects of treatment with tretinoin cream on human skin by     using non-invasive optical imaging technologies.   "
66831|NCT02410967|"     This study is a pilot test of Attention Bias Modification Training (ABMT) among clinic     referred children and adolescents with subthreshold impairing anxiety (i.e., anxiety and     related impairment that fails to meet criteria for an anxiety disorder diagnosis). Half of     participants will receive 8 sessions of computer administered ABMT and the other half of     participants will receive a 8 sessions of a computer administered control task.   "
66832|NCT02410954|"     Locus coeruleus (LC) norepinephrine (NE) neuron activity has been convincingly linked to     regulation of acute fear. This study will address whether LC NE activity examined through     pupil measures will reflect carbon dioxide (CO2) induced fear-responses in humans and if     transcranial direct current stimulation (tDCS) can mitigate these effects. A 2 year R21 phase     establishing feasibility, tolerability, safety, and proof-of-concept (POC) in terms of     capacity to engage LC NE neurons with tDCS, followed by a 3 year R33 parallel-group,     double-blind, randomized, controlled trial will determine the degree to which engaging LC NE     neurons with tDCS improves clinical symptoms.   "
66833|NCT02410941|"     Utilization of diagnostic imaging in the Emergency Department has increased dramatically over     the past two decades, driven by an increased availability of advanced imaging, legal     pressures to exclude serious diagnoses in low-risk patients, patient expectations, and the     tendency to associate more testing with a higher quality of care. However, this rise in the     use of diagnostic imaging, particularly in low-risk patients, may not be taking into account     the risk of radiation exposure to patients, or the impact on finite health system resources.     The objective of this project is to improve the appropriateness of CT imaging in Alberta     Emergency Departments by advancing awareness of, and adherence to, evidence-based guidelines     for CT imaging of patients with mild traumatic brain injury (MTBI) and suspected pulmonary     embolism (PE). These two clinical scenarios have been selected because of evidence of     significant variation in imaging practices across Alberta, and the robust evidence base that     exists to guide CT imaging decisions such as the Canadian CT Head Rule and the Pulmonary     Embolism Rule Out Criteria.   "
66834|NCT02410928|"     Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the     vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy,     videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy,     duration and hemodynamic responses during the procedure.   "
66835|NCT02410915|"     Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on     short- and long-term functioning, disability and health compared to conventional gait     training as part of an inpatient rehabilitation program early after stroke.   "
66836|NCT02410902|"     The purpose of this study is to determine whether CM-AT is safe and effective in treating the     core symptoms of autism in children with all levels of fecal chymotrypsin.   "
66837|NCT02410889|"     The purpose of this project is to develop the method of combined recording of     electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) in order to     improve understanding of the relationship between electrical (EEG) and blood flow (fMRI)     responses to epileptic discharges as a necessary step towards clinical use. One factor that     currently limits the use of EEG−fMRI in patients with epilepsy is that a relatively large     proportion of patients do not show any fMRI response despite epileptic activity having been     detected on the EEG recorded during scanning. The reasons for this are unclear, which makes     it difficult to predict in advance whether useful information will be gained from the     scanning session. What is it about some epileptic discharges that results in a detectable     change in the fMRI signal, while others which are no less obvious or frequent do not? This     question will be addressed by determining the factors that are responsible for the occurrence     of robust fMRI signal changes via detailed morphological, topographical and spectral analysis     of the EEG signal on an event by event basis.   "
66906|NCT02409992|"     The proposed research will focus on the development of a brief emotion-coaching (EC)     parenting program (which directly targets child emotion awareness/recognition and affective     empathy), that will be combined with a well-established parent management training program     (Helping the Noncompliant Child; HNC) for treating oppositional defiant disorder (ODD) in     children who also have limited prosocial emotions (e.g., lack of guilt and empathy, callous     use of others).   "
66838|NCT02410876|"     Patients with obstructive or neurogenic lower urinary tract disease will be invited to     participate. Upon agreement they will undergo an assessment of bladder function     (questionnaires) and bladder biopsies at 2 time-points. Bladder biopsies will be evaluated     for molecular changes in the laboratory and compared to the functional findings.By uncovering     the molecular similarities and differences between BLUTD and NLUTD, the investigators will     elucidate some of the causative factors in the development of these disorders and highlight     the impact of myogenic and neurogenic components postulated to be involved. The project     involves close collaboration between clinical and basic research.   "
66839|NCT02410863|"     This is an open-label, multi-center, clinical phase II study to explore the correlation of     the genetic make-up of the treated tumor before start of therapy and to correlate clinical     response at 8 weeks as well as metabolic response at 2 and 8 weeks with genetic features of     the tumor.      It will be conducted as a rationale optimization of targeted therapy in BRAF naïve and     pretreated patients.      Prerequisite for all patients is the availability of tumor sample at start of treatment in     order to determine the underlying driver mutation (BRAF mutational status) as well as     molecular composition by next generation sequencing (NGS) and assessable lesions for biopsy     at week 2. Melanoma patients in stage III (non-resectable) and stage IV are sorted into     Cohort A,B or C according to their previous BRAF-treatment and treated with dabrafenib and     trametinib (cohort A and C) or dabrafenib (cohort B).   "
66840|NCT02410850|"     Obstructive sleep apnea (OSA) is a highly prevalent breathing problem that occurs during     sleep. OSA have been associated with the obesity epidemic in developing countries;     additionally, high OSA prevalence rates are present in populations with cardiovascular and     metabolic disorders. Two OSA treatments are currently available, oral appliance (OA) therapy     and continuous positive airway pressure (CPAP). OAs are an underutilized non-surgical     treatment and few studies have analyzed their long-term effectiveness for patients with OSA.     The purpose of this study is to assess the long-term effectiveness of OA therapy in patients     with OSA and to explore any changes on cardiovascular related morbidity and mortality related     to this therapy.   "
66841|NCT02410837|"     The purpose of this study is to evaluate outcomes following electromagnetic navigation     bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.   "
66842|NCT02410824|"     Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.   "
66843|NCT02410811|"     The purpose of this study is to use cardiac magnetic resonance imaging (CMR) and     echocardiographic tissue Doppler imaging to demonstrate a unique restrictive cardiomyopathy     of sickle cell disease. The investigators will characterize its frequency and how it might     change (e.g., presence/absence and severity) over a 2-year period.   "
66844|NCT02410798|"     The overall goal of this feasibility study is to advance the development of NeuRx DPS for the     intended use of stimulating the diaphragm to provide respiratory assistance in patients at     risk of prolonged mechanical ventilation in the ICU. This is the first step to determine the     technical feasibility of the short-term TransLoc DPS electrode in humans.   "
66846|NCT02410772|"     The purpose of this study is to determine whether one or two four-month regimens of     tuberculosis treatment are as effective as a standard six-month regimen for treatment of     pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week,     with direct observation of each dose by a health-care worker at least five of the seven days     of each week.      The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and     pyrazinamide followed by four months of isoniazid and rifampin.      The first short regimen is a single substitution of rifapentine for rifampin: two months of     isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and     rifapentine.      The second short regimen is a double substitution of rifapentine for rifampin and     moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and     pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin.      Target enrollment is 2500 participants. Each study participant will remain in the study for     18 months in order to include at least 12 months of evaluation of whether the participant's     TB recurs.   "
66847|NCT02410759|"     200 women will be randomly divided into 2 equal groups using computer generated random     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will     receive ergometrine 0.5mg (methergin®, Novartis, Switzerland).   "
66848|NCT02410746|"     Effective postoperative pain control is an essential component of surgery. Adequate analgesia     improves patient comfort and satisfaction, thereby permitting earlier mobilisation, faster     recovery and less likelihood of complications.The majority of surgeons will place 10ml of     local anaesthetic into the breast pocket or inject it into the breast skin following breast     surgery. A more specific technique is to identify the nerves supplying the breast and put the     local anaesthetic directly around them (Pec block). This nerve block has recently been     described and is increasingly being used by anaesthetists for surgery under local anaesthetic     or for post-operative analgesia. It has been shown to provide better and more specific pain     relief in several studies.      Anaesthetists use an ultrasound machine to identify the anatomical landmarks for the nerves     and they inject into the vicinity. They do not have direct vision and there is a risk of     causing morbidity or the block not being effective. It is much easier for a surgeon to apply     the block, as they can see the anatomical landmarks. Despite this, very few surgeons are     aware of the technique.      The study group consists of patients undergoing bilateral cosmetic breast surgery at BMI     Edgbaston and Priory hospitals and Spire Parkway and Southbank hospitals in Birmingham and     Worcester. If a patient consents to being involved in the research, they will have one breast     randomised to receiving a pec block and the contralateral (opposite) breast will receive the     same amount of local anaesthetic placed in the breast pocket in a non-targeted fashion. The     patients and researcher will be blinded as to the allocation. Patients will complete a verbal     numeric pain score for each breast at set intervals until they are discharged.In addition,     the investigators will specifically ask which breast is the most painful at each time point.      The results of the study may improve patient care.   "
66849|NCT02410733|"     The purpose of this study is to determine the safety and tolerability of intravenous     administration of a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated     antigens in patients with advanced melanoma.   "
67191|NCT02406261|"     The purpose of this study is to study the effect of lanabecestat on how the body absorbs and     processes 3 other medications, midazolam, simvastatin and donepezil and how these 3     medications affect lanabecestat when they are taken together. This study is in 2 cohorts,     Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit     is required within 30 days prior to the start on the study   "
66850|NCT02410720|"     Colonoscopy is the preferred procedure to investigate any large-bowel disease in adults and     children. In addition, colonoscopy is the current gold standard for colorectal cancer     screening due to its high diagnostic capabilities and its unique feature that permits     sampling and removal of pathology. For optimal performance and visualization of details,     however, an adequate bowel preparation is essential. Inadequate bowel preparation is     associated with cancelled procedures, prolonged procedure time, incomplete examination,     increased cost and possibly complications, physician frustration and patient anxiety, but     most importantly serving to impede colorectal cancer screening and surveillance.      A good bowel preparation would need a solution with a reasonable volume, acceptable taste,     minimal diet restrictions, and easy to follow instructions; and would also need patients'     adherence to the instructions and diet restrictions. Noncompliance of patients to the diet     restrictions, the starting day of diet, the timing of drinking the solution, and other     instructions play an important role in rendering the colon preparation inadequate.      Aim: The investigators aim, at assessing the influence of having a reminder mobile     application on the compliance and adherence to instructions and diet and consequently on the     quality of colon preparation.      Hypothesis: The investigators' hypothesis is that patients having a customized mobile App     reminding them systematically about instruction and time of intake of the preparation will     have a better adherence to the prep protocol and likely on the quality preparation than those     given written and verbal instructions in clinic.   "
66851|NCT02410707|"     The purpose of this study is to describe the safety and efficacy of nitrous oxide     administration for pain and anxiety before propofol in patients requiring any procedure under     sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic,     and/or dissociative agents to relieve anxiety and pain associated with diagnostic and     therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but     provides no analgesia. Short acting opioids may be used for pain relief, but come with the     risk of respiratory depression. An optimum analgesic to relieve pain in patients who need     procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be     a suitable agent, but literature supporting or rejecting its use in adults is lacking. This     study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency     Department with painful condition requiring procedural sedation are the targeted population.     Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a     hand held mask before they receive propofol for the procedure. Information regarding their     vitals, pain scores and medical condition will also be collected.   "
66866|NCT02410512|"     This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and     pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally     advanced, recurrent, or metastatic incurable solid malignancy that has progressed after     available standard therapy; or for which standard therapy has proven to be ineffective or     intolerable or is considered inappropriate; or for which a clinical trial of an     investigational agent is a recognized standard of care. Participants will be enrolled in two     stages: a dose-escalation stage and an expansion stage.   "
67761|NCT02398786|"     The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that     collects information on myotonic dystrophy (DM) to aid researchers in developing new,     effective treatments and help identify participants for research studies and clinical trials.   "
66852|NCT02410694|"     Overview of Study Design:      This is an open phase II, single-arm, multi-center study to evaluate progression free     survival in patients receiving ixazomib in combination with thalidomide and dexamethasone     (ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months.      The patient population will consist of adult male and female patients with multiple myeloma     (MM) with relapsed and/or refractory disease after at least one prior treatment line.      In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide     100mg at days 1 to 28 (50mg in patients aged ≥75 years), and dexamethasone 40mg (20mg in     patients aged ≥75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number of     cycles is 8. Treatment will be discontinued in case of progressive disease or in case of no     response after 4 cycles (≤ SD after 4 cycles). After discontinuation of therapy an end of     treatment visit (EOT) will be performed within 14 days after the last dose of the last     combination treatment cycle.      After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients     aged ≥ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be     administered to patients with ≥ MR for a maximum period of 12 months. Patients who completed     less than 8 cycles of ITD treatment do not qualify for maintenance phase.      Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib     maintenance therapy has concluded or discontinued the maintenance phase.      A safety analysis will be conducted after enrollment of the first 6 patients and completion     of at least two cycles in every patient.   "
66853|NCT02410681|"     Excessive mechanical forces can cause complications of dental implants and their     suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft     tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during sleep)     is considered as an important source of mechanical forces in the oral environment. Therefore,     in this study, the investigators will investigate whether sleep bruxism is associated with     implant and peri-implant complications.   "
66854|NCT02410668|"     To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors     in subjects with over weight and obesity, 50 patients will be randomly allocated to receive     placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence     the investigators' diet and exercise program too. At the first and the end of the     intervention, weight, waist and hip circumference, lipid profile and some inflammatory     markers will be assessed and compared between groups.   "
66855|NCT02410655|"     The purpose of this study will be to evaluate a standardized, evidence-based protocol versus     a conventional approach for the dosing of oxytocin in vaginal delivery.   "
66856|NCT02410642|"     NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker     of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical     significance, pattern of excretion and links to perioperative factors are poorly described.     We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary     bypass, and explore possible associated variables.   "
66857|NCT02410629|"     The investigators are trying to determine the therapeutic effect of the music glove and     conventional hand exercise program to the subacute stroke patients. All participants will be     randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3     weeks with a minimal 3 hours exercise time per week. Participants will receive the other     intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline,     post therapy after first intervention, 3-week post intervention follow up, 3-month post     stroke, post therapy after second intervention, 3-week post second intervention follow up,     and 6-month post stroke follow up visits.   "
66858|NCT02410616|"     To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT)     for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss     patients in secondary care   "
66860|NCT02410590|"     The primary objective of this trial is to compare the preference between two strategies of     neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic     abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium +     Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS)     scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is     that the strategy Rocuronium + Sugammadex provides a better surgical visual field in obese     participants undergoing laparoscopic abdominal surgery than the strategy Succinylcholine +     Cisatracurium + Neostigmine/Atropine as measured by VNS scores.   "
66861|NCT02410577|"     The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for     humanized antibody called J591, that is attached to a radioactive material called     Zirconium-89) in patients with glioblastoma multiforme.   "
66862|NCT02410564|"     To determine the efficacy of a CBT-I intervention in improving sleep and other quality of     life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I     intervention among newly diagnosed cancer patients.   "
66863|NCT02410551|"     The goal of this clinical research study is to learn if giving pacritinib before standard of     care drugs followed by an allogeneic stem cell transplant can help to control     myeloproliferative neoplasms. The safety of this therapy will also be studied.   "
66864|NCT02410538|"     The intervention consists of the delivery of a list of 21 questions to the relative of each     patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of     the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The     information comprehension at Day 5 (± 1) will be compared between families that received the     list of FAQ and families that received information as usual (without providing the list of     FAQ   "
66865|NCT02410525|"     In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2     different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects.     Positron emission tomography will be used to characterize tissue distribution. The study will     also characterize how the study drug behaves in the body, its safety, and how the body     tolerates it.   "
66867|NCT02410499|"     The purpose of this study is to characterize the effects of 85 days treatment with MLN1202 on     urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced     kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR>300 mg/g) based on     average of 3 consecutive first morning voids sample collection.   "
66869|NCT02410473|"     Neonates, children with single ventricle congenital heart disease, and those undergoing     multiple complex cardiac surgeries are at high risk of increased perioperative blood loss,     and blood product transfusions. In addition, some of these patients will present an increased     risk of postoperative thromboembolic complications. For a long time, bleeding management has     been based on the empiric administration of different blood products (e.g. platelet     concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic agents, and     surgical manipulation. Recently, the use of viscoelastic tests (e.g. thromboelastography     (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better assessment of     perioperative coagulopathy, and a more 'rational' treatment of bleeding. While TEG and ROTEM     record the viscoelastic properties of whole blood by measuring mechanical impedance and     related changes during clot formation, T2MR, a miniaturized, magnetic resonance-based     diagnostic platform, measures how water molecules react in the presence of magnetic fields to     evaluate a broad range of hemostasis measurements. In this study, we will prospectively     collect demographic data, surgical characteristics, the amount of perioperative bleeding and     blood product transfusion, results of laboratory assays, and postoperative outcomes (30-day     follow-up or until discharge), with the aim to assess our current practice, and develop an     algorithm-based approach for the administration of targeted blood product and pro-coagulant     therapies. Our goals are: the reduction of blood product utilization, the reduction of the     incidence of massive bleeding and postoperative thrombosis.   "
66870|NCT02410460|"     This study is a prospective, double-blind, randomized comparison study of different     anesthesia methods in rhytidoplasty surgery. The study is designed to determine whether     post-operative side-effect profiles in patients undergoing elective cosmetic facelift surgery     can be decreased through the use of propofol/ketamine anesthesia with bispectral monitoring     (PKA-BIS) rather than general anesthesia, without increasing intra-operative time,     side-effect profiles, or patient recall. Approximately 30 subjects undergoing facelift     surgery performed by the principal investigator will participate.   "
66871|NCT02410447|"     Chronic soft tissue wounds of the lower limbs are painful and debilitating condition that     significantly reduce the quality of life of the patient. They often do not respond to     conservative treatments or advanced wound managements. Focused and defocused extracorporeal     shock wave therapy can be a viable alternative therapeutic strategy.      The purpose of the study was to examine the effects of defocused extracorporeal shock wave     treatment on chronic soft tissue wounds of the lower limbs, in terms of the rate of wound     healing and pain control.   "
66872|NCT02410434|"     The specific objectives of this study are reduce stigma towards lesbian, gay, bisexual, and     transgender persons in Swaziland and Lesotho, using performance ethnography at community     roundtables.   "
67192|NCT02406248|"     A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the     cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with     non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles     are depolarized) elevation myocardial infarction   "
66873|NCT02410421|"     Although repetitive trans-cranial magnetic stimulation (rTMS) is an effective therapy for     resistant depression, it still fail to remit up to 70% of these patients. We hypothesize that     personalizing the procedure using functional MRI to better select dysfunctional regions and     robotic coil placement to stimulate these regions homogeneously, will increase its efficacy.     Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial     direct current stimulation (tDCS).      In this small proof of principle study our primary outcome measure will be the correction of     the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary     outcome measurements.   "
66874|NCT02410408|"     Adverse events are also the cause of suffering in health professionals involved (second     victims). This study has the aim of design and evaluates two applications for staff of     hospital and primary care settings with the intention of improving their capacity to conduct     Root Cause Analysis (RCA) and to help them introducing patient safety certification (PSC).      A single-blind randomized controlled trial shall conduct with a control and an experimental     group (N=84) in both cases. The characteristics of both apps shall specify based on the     suggestions of health professionals and shall design for Android and IOS (for iPhone or     Ipad).      The randomly subjects in the control group shall receive oral and written information and the     experimental group used App for two months. Pre- and post- measures shall include: patient     safety knowledge and culture and self-perceived capacity to enhance RCA or follow-up PSC. In     the experimental group, data shall also collect on their previous experience with information     and communication technologies, their rating of each App. The inter-group intervention     effects shall calculate by univariate linear models and ANOVA, with the pre- to     post-intervention differences as the dependent variables.   "
66875|NCT02410395|"     The aim of this trial was to compare two different uterotomy surgical techniques on the     occurrence of a uterine niche and the risk of a number of short- and long-term gynecological     complications associated with the presence and size of the niche.   "
66876|NCT02410382|"     This study will look at how dexamethasone and placebo influence radiation fatigue, quality of     life and number of treatment days missed during radiation therapy or radiation therapy and     chemotherapy for cancer.   "
66877|NCT02410369|"     In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in     patients who underwent an adjuvant chemotherapy after the complete resection of     non-small-cell lung cancer.   "
66878|NCT02410356|"     This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in     adults with GHD who have previously been treated with rhGH.   "
66879|NCT02410343|"     The primary objective of this study is to determine the efficacy of 6 months of treatment     with TV-1106 compared with placebo on body fat composition.   "
66880|NCT02410330|"     In acute coronary artery disease, pre-clinical studies have indicated that, during a     continuous infusion of intravenous perfluorocarbon containing microbubbles, the ultrasonic     power delivered from a diagnostic ultrasound transducer is capable of restoring     microcirculatory flow and improving epicardial recanalization rates obtained by conventional     therapy, a process known by Sonothrombolysis. The investigators proposed to examine the     feasibility, safety and efficacy of such an ultrasound guided approach in 100 patients with     ST segment elevation myocardial infarction (STEMI).   "
66881|NCT02410317|"     The cesarean section is one of the most commonly performed surgeries in the world and it     represents 20% of the births in France. Postoperative pain is moderate-to-severe during the     first 48 hours after this procedure. Thereby its control is prominent for the medical team in     order to shorten the duration of hospital stay as well as to permit an early return to daily     activities for these surgical patients.      Pain control after cesarean section is usually based on non-opioids and epidural     administration of morphine if an epidural catheter has been previously placed for the     procedure. However epidural morphine is associated with a number of side effects. Wound     infiltration with local anesthetics has been widely used in the multimodal management of     postoperative pain and it may reduce postoperative morphine consumption.      In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of     this study will be to compare the analgesia provided by a local anesthetic wound 48-hours     infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia     (epidural morphine bolus). Quality of pain control will be assessed with the measurements of     morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3     months, patients will be interviewed to assess their residual pain and their satisfaction.      It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural     morphine analgesia to control pain after cesarean section, and be associated with a reduction     of side effects related to the analgesics.   "
66882|NCT02410304|"     This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D)     concerning the rheumatoid arthritis in order to monitore the treatment. This study will     provide the exact number of patients in remission according the 3 methods.      It could allow to assess the concordance between the 3 evaluated methods. This study will     permit to define the best method which limit the evolution of structural damages ( principal     criteria).   "
66883|NCT02410291|"     Rectal toxicity limits dose escalated intensity modulated radiotherapy (IMRT) for prostate     cancer. The dose volume constraints that predict for rectal toxicity require minimizing     prostate motion and rectum and bladder filling of IMRT .5-15 . The volumetric changes and     internal organ motion during prostate IMRT increases risk of PSA failure in patients with     large rectums at the planning CT scans. Patient preparation for IMRT planning is crucial .The     literature is limited regarding the effectiveness of educational intervention with behavioral     reinforcement for patients, and a gap if exists literacy level is considered. Patients often     cannot comprehend verbal or written instructions and have difficulties following through with     recommended regimens.23 Using multimedia such as Internet, audio-visual media such as DVD and     even the telephone can enhance patients' knowledge and understanding about importance of     preparation for IMRT for prostate ca. Thomas's study showed that in patients undergoing     radiotherapy and chemotherapy, the video group had lower anxiety scores compared with the non     video group. At SOCC patients have been provided with verbal information about bladder and     rectum preparation for prostate planning CT scan and IMRT. Patients should have a fullish     bladder and empty rectum at the time of CT simulation. If the rectal diameter is > 4cm, the     patient will be asked to empty his stool/gas and re-scanned. The 3- months review of patients     preparedness for prostate IMRT showed that only 13/55 patients were adequately prepared but     42/55 (76%) of patients needed to be re-scanned due to inadequate bladder (21/42, 50%) or     rectum filling 28/42, 67%) . Also, 2/13 (15%) patients were still not prepared at the second     resimulation despite that they received a phone call with the instructions. The investigators     plan to investigate if a multimedia education strategy will decrease costly resimulation rate     for patients with prostate cancer.   "
67193|NCT02406235|"     The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic     counselling quality and satisfaction with a new onco-genetic BRCA testing model.   "
66884|NCT02410278|"     The primary objective of this study is to evaluate whether montelukast can reduce the     severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating     Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with     relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as     follows: To evaluate whether montelukast after oral administration of DMF in participants     with relapsing forms of MS decreases discontinuations due to GI events and reduces the number     of participants taking symptomatic therapies for GI events; To investigate the effect of     montelukast on the incidence of flushing events after oral administration of 240 mg DMF in     participants with relapsing forms of MS.   "
66885|NCT02410265|"     This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy,     feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and     unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian     university students. The investigators aim to assess if these novel electronic health     (eHealth) interventions can be integrated into Indian university systems to increase access     to efficacious, less stigmatized, and cost-effective mental healthcare.   "
66886|NCT02410252|"     This is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous     temperature monitoring device, as a clinical support and patient self-management tool in the     management of pediatrics patients on myelosuppressive therapies for acute leukemia and other     childhood cancers.   "
66887|NCT02410239|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of mesenchymal     stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).   "
66888|NCT02410226|"     The study will assess the benefit of using spinal ultrasound before epidural catheter     insertion compared to the conventional palpation technique in women undergoing cesarean     section.   "
66889|NCT02410213|"     This is a Phase II, open-label, non-randomized, multi-center, single arm study to     characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric     Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15     mg/kg dose of Ferric Carboxymaltose.   "
66890|NCT02410200|"     The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate)     on brain magnetic resonance imaging (MRI) lesions in pediatric participants with     relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to     characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to     evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.   "
66996|NCT02408822|"     Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia.     Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial     disease.      This randomized controlled trial is designed to prove the superiority of a drug-eluting     balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment     of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.      The hypothesis is that use of drug-eluting balloon will improve post-interventional patency     of the access, and therefore, limit numbers and days of hospitalization for maintenance of     hemodialysis vascular accesses.   "
66891|NCT02410187|"     Clinical experience has shown that metastasis can often be limited in number and location,     and thus amenable to local treatment. The term oligometastasis describes an intermediate     state of cancer spread between localized disease and widespread metastasis. The implication     of such an intermediate state is that the disease can be cured by using metastasis-directed     therapy. Historically, in some patients with oligometastases in the liver or lungs, surgical     resection was often indicated, as abundant evidence suggested it could improve     progression-free or overall survival. Recently, several studies have reported promising     outcomes of >80% local control with Stereotactic Body Radiotherapy (SBRT) in patients with     lung or liver oligometastases. Nonetheless, very few studies have focused on non-liver,     non-lung extracranial oligometastatic lesions treated with SBRT, and such studies have     limitations of a retrospective nature and small sample sizes.Because allmost studies are     based on single-arm studies without appropriate controls, the level of evidence to support     SBRT is weak. Randomized trials are therefore necessary to establish the utility of SBRT for     oligometastatic disease.      This study is designed as a randomized phase II study. Patients will be randomized between     current standard treatment (Arm 1) versus standard treatment +SBRT (Arm 2) to all known     disease.   "
66892|NCT02410174|"     The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic     body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC)     in medically inoperable patients and/or patients who refuse surgery. Standard treatment of     RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly     invasive and are associated with significant side effects. SBRT is a non-invasive,     non-surgical treatment that requires tumor immobilization and image guidance in order to     deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat     primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects     enrolled in this study will then be followed and evaluated for toxicity, serum chemistry,     complete blood count, and urinalysis. In addition, they will undergo renal scans to assess     the functionality of their renal tissue.   "
66893|NCT02410161|"     Background: As the main alternative fuel to glucose for the brain, increased plasma ketones     could potentially help compensate for brain glucose hypometabolism occurring during aging.     The precursor long-chain n-3 polyunsaturated fatty acid (PUFA), α-linolenic acid (ALA), is     normally mostly β-oxidized and so could potentially be used to stimulate ketogenesis in     humans.      Objective: To compare the impact of an ALA-rich supplement on the ketogenic response in young     and older healthy adults.      Design: Ten young and ten older adults will consume a flaxseed oil supplement providing 2 g/d     of ALA for 4 weeks. Plasma ketones, free fatty acids, triglycerides, glucose and insulin will     be measured over 6 h during two metabolic study days, one before and one at the end of the     supplementation.      Hypothesis: ALA-rich supplement for 4 weeks will increase ketone production in both groups.   "
66916|NCT02409862|"     The neuropeptide oxytocin (OXT), originally known for its role in inducing uterine     contractions has been shown to be involved in many of the social capacities that seem to     change with age, such as emotion detection and identification, enhanced social memory,     empathy, and trust. Thus, age-related changes in the OXT system may underlie differences     between young and older adults in socioemotional functioning. Research on the effects of     oxytocin in aging is very scarce; therefore, the purpose of this research project is to     determine the effects of oxytocin on socioemotional aging. The aim of this research is to     examine the behavioral and neural effects of OXT on decisions of trust in social     interactions, perceptions of facial trustworthiness, the ability to read faces, and levels of     empathy with other people in samples of young and older adults.   "
66917|NCT02409849|"     This is phase II study on the efficacy of octreotide lar as maintenance treatment after     first-line chemotherapy for patients with unresectable or metastatic gastro-entero-pancreatic     or esophageal neuroendocrine carcinomas.   "
66894|NCT02410148|"     Glaucoma remains a disease with an unclear and complex underlying pathophysiology. Recently,     researchers have emphasized not only intraocular pressure (IOP) or vascular dysregulation,     but also translaminar pressure's (TPG) role in glaucoma (TPG=IOP-ICP). A higher TPG may lead     to abnormal function and optic nerve damage due to changes in axonal transportation,     deformation of the lamina cribrosa, altered blood flow, or a combination thereof leading to     glaucomatous damage. However only invasive ICP measurements are available within the     contemporary medicine. The ideas for non-invasive ICP measurement have been approached since     about 1980. Most of the proposed technologies were based on ultrasound and were capable of     monitoring blood flow in intracranial or intraocular vessels, cranium diameter, or acoustic     properties of the cranium. Broad research has extended into sonography of optic nerve sheath     and its relation with elevated ICP. However, most of these correlation-based methods had the     same problem—the need of individual patient specific calibration. Seeking to measure absolute     ICP values, researchers from Kaunas University of Technology created a non-invasive method,     which does not need a patient specific calibration. The method is based on direct comparison     of ICP value with the value of pressure Pe that is externally applied to the tissues     surrounding the eyeball. Intracranial segment of ophthalmic artery (OA) is used as a natural     sensor of ICP and extracranial segment of OA is used as a sensor of Pe. The special two depth     transcranial Doppler (TCD) device is used as a pressure balance indicator when ICP = Pe.      The aim of our study is to assess TPG in patients with primary open open-angle glaucoma     (POAG). In addition the investigators want to measure ICP in patients with papilledema (PE)     in order to compare them with glaucoma patients.   "
66895|NCT02410135|"     The objective of this exploratory pilot study is to assess whether Mirabegron (Myrbetriq™)     will improve the quality of sleep and Lower Urinary Tract Symptoms (LUTS) in men and women     presenting with LUTS and disordered sleep.   "
66896|NCT02410122|"     While a fair amount of clinical data on Stargardt disease type 1 (STGD1) have been published,     very little is known about Stargardt disease type 4 (STGD4). The ProgStar 04 study is an     important opportunity to leverage the infrastructure, clinical trials sites, methods, and     central reading center of the ProgStar program to investigate the progression of STGD4 and     will help to establish patient cohorts worldwide for future clinical trials.   "
66997|NCT02408809|"     The investigators of this study aim to evaluate the impact of a new orthopaedic related     smoking cessation discussion on smoking behavior. Considering the high prevalence of patients     who smoke and receive orthopaedic management, we are interested in determining whether an     orthopaedic smoking cessation discussion impacts smoking abstinence self-efficacy over time     compared to a general smoking cessation discussion.   "
66998|NCT02408796|"     This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with     either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible     subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is     designed to characterize safety, procedural factors and clinical effect of OTO-201     administered in subjects with AOMT.   "
66897|NCT02410109|"     Perinatal depression is a significant concern, particularly for low-income women. Many cases     of perinatal depression are complicated by comorbidities such as post-traumatic stress     disorder symptoms, anxiety, and intimate partner violence. Providing perinatal mental health     services to women in home visiting programs could have considerable public health     significance. This study will develop and test an integrated model of mental health services     embedded within home visitation (HV) programs. This model will (1) incorporate a protocol for     systematic screening and referral; (2) strengthen formal linkages between HV programs and     other components of service systems; (3) promote the capacity of service systems to provide     evidence-based early intervention and treatment for depression; and (4) facilitate the     receipt of early intervention and treatment services for perinatal depression and comorbid     conditions. This will be the first model to our knowledge that systematically integrates     screening, referral, and early intervention and treatment for perinatal depression and     associated comorbidities within HV programs.      The specific aims are:        1. To develop an integrated model of perinatal depression care within HV programs. This          integrated model (SCRIPT) will incorporate screening, referral, and individualized          prevention and treatment services.        2. To assess the feasibility of implementing the SCRIPT model with high fidelity in two HV          programs. One HV program—DRUM Healthy Families—will use paraprofessionals as          interventionists while the other program—M&I Nursing—will use nurses and social workers          as interventionists.        3. To determine the impact of the SCRIPT model on depressive symptoms and major depressive          episodes.   "
66898|NCT02410096|"     The purpose of this study is to investigate the bronchial inflammation and     hyperresponsiveness after oil supplementation. Before and after oil supplementation the     investigators measure decrease in lung function after exercise-challenge in a cold chamber     and increase of inflammatory markers in the blood.   "
66899|NCT02410083|"     The purpose of this study in to evaluate efficacy and tolerability of Clopirin and     clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery     intervention.   "
66900|NCT02410070|"     The objective of this study is to compare a minimal invasive approach with the conventional     flexor carpi radialis approach for volar plating of distal radial fractures.   "
66901|NCT02410057|"     Formula composition has developed to resemble breast milk as close as possible, but there are     still considerable differences between formula and breast milk composition, probably     resulting in higher risk of overweight in childhood and higher incidences of infections in     formula-fed infants. Protein levels are still higher and constituents such as     alpha-lactalbumin lower in formula than in breast milk. By adding more alpha-lactalbumin to     formula, rich in tryptophan, the resulting amino acid composition will allow further     reduction of protein in formula. The investigators intend to include 320 infants, where 80     will be exclusively breastfed and the remainder assigned in a double blind, controlled,     randomized manner to one of three formula groups; two experimental, protein reduced formula     with two different levels of alpha-lactalbumin and one group given standard infant formula.     The intervention period is from 4-8 weeks until 6 months of age. The infants will be followed     by growth parameters, blood-, urine- and fecal biomarkers and health parameters until 5 years     of age. The experimental formula will possibly result in growth, metabolism and gut     microbiota as well as health parameters more similar to those of breastfed infants   "
66902|NCT02410044|"     Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life     patients with bone metastases treated with osteoprotective agents.   "
66903|NCT02410031|"     The study will be an observational, cross-sectional study of knowledge, understanding, and     self-reported behavior among a sample of physicians with recent experience in prescribing     Diane-35 or its generics in a total of five European countries. The primary objective of this     study is to measure physician knowledge and understanding of the key information contained in     the Diane-35 educational material: Patient information card, and Prescribers' Checklist.      Specifically, the following objectives will be addressed:        -  Investigate whether physicians have received any educational material related to          Diane-35 or its generics        -  Assess physicians' knowledge and understanding of key safety information pertaining to          the patient information card        -  Assess physicians' knowledge and understanding of key safety information pertaining to          the following areas:        -  Contraindications relevant to thromboembolism        -  Risk factors for thromboembolism        -  Signs and symptoms of thromboembolism   "
66918|NCT02409836|"     The objective of this study was to examine the amount of dentifrice ingested and used by     various age groups of children.   "
66907|NCT02409979|"     Room air insufflated during colonoscopy cannot be completely suctioned, is not easily     absorbed and remains in the bowel for quite some time, resulting in prolonged bowel     distension with the discomfort of bloating. Sufferers often experience a sensation of     fullness and abdominal pressure, relieved only after expulsion of the residual gas, often     accompanied by colic pain. This can be a lengthy process, and some patients continue to     report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy     is an adverse event commonly reported by patients, and definitely associated with the     procedure. Published reports show that the use of carbon dioxide (CO2) insufflation     significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results     of the investigators' previous study about on-demand sedation colonoscopy in diagnostic     patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion     of water to distend the lumen during insertion; suction of infused water, residual air     pockets an feces predominantly during insertion) achieved significantly lower real-time     insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating     scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2.     Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher     bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences     were significant only at discharge. The investigators decided to conduct a prospective     randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test     the hypothesis that patients examined by the combination of WE-CO2 will have significantly     lower bloating scores at specific time points after colonoscopy than those examined using     WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on     patients comfort and activities in the post-procedure period.   "
66908|NCT02409966|"     There are different protocols to treat gum diseases. One relevant differential aspect is     related to time. There are protocols that usually takes one to two months to be completed     while other are completed within 24 hours. Although both protocols seem to provide clinically     similar improvements, there are some positive aspects related to the short-term one. Among     them lower number of clinical sessions, easier schedule and costs advantages. However, there     are many other relevant aspects that can be helpful for patients and clinicians decisions     regarding type of treatment.      This study evaluates if and how clinically effective protocols used to treat periodontitis     affect quality of life related to individual's oral statuses. In addition, the experiences of     fear, anxiety and pain before and after these specific protocols are monitored.   "
66909|NCT02409953|"     Like in the full immersion, studied in the context of diving, immersion in water causes a     cascade of events with hemodynamic and hormonal consequences.      First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60     minutes later, hypovolemia by stimulating diuresis.      Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.      However, when the labor progresses, the dilatation bath is no longer sufficient and epidural     analgesia remains the only effective method to control pain.      Used before the realization of an epidural analgesia, dilatation bath could affect blood     volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked     to the installation of sensory block of the epidural analgesia in the parturient (severe     prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal     distress).      Before beginning a study in pregnant women, it seems essential to study the hemodynamic     consequences of the dilatation bath in a comparable population of volunteers healthy young     women and out of the obstetrical context.   "
66910|NCT02409940|"     Despite being a miracle of modern medicine, solid organ transplant recipients are always at     risk of rejection, and remain dependent on lifelong immunosuppression. Currently used     immunosuppressive drugs suppress the potential of immune system and interfere with the     metabolism of medications. Cellular therapies currently being investigated for this purpose     require the use of ablative radiotherapy. The investigators are using a less toxic strategy     by harnessing the immunosuppressive potential of the MSCs in the Kidney Transplant (KTx)     recipients and studying immunomodulation mediated by these cells in the KTx patients.      Hypothesis MSCs interfere with signalling of Immune cells like T cells, B cells and Dendritic     cells which leads to improve graft survival of renal transplant patients.      Aim To investigate effect of MSCs on immune cell repertoire in a donor specific mediated     response.      The investigators aim to collect peripheral blood from 30 patients (10 patients for     autologous cell infusion and 10 for allogeneic (donor derived cell infusion) at various time     intervals following MSC therapy. 10 patients serve as controls on standard dose of drugs but     without MSC infusion. This peripheral blood would be utilized for isolation of mononuclear     cells and performing various immune assays on these cells in a donor specific response.   "
66911|NCT02409927|"     Lower brain glucose uptake is present before the onset of cognitive deterioration and may     increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main     alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and     are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due to     incomplete absorption so the investigators examined whether homogenisation into a skim milk     matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT taken     without homogenisation into a matrix (bulk MCT [MCT-B]).      Hypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in     higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and     MCT-H on ketogenesis will be dose-dependent.   "
66912|NCT02409914|"     The purpose of this study is to investigate whether higher insulin resistance in young women     with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of     glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative     cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained. The     potential relationships between anatomical and functional cerebral parameters and insulin     resistance were assessed with the updated homeostasis model assessment (HOMA2-IR).   "
66913|NCT02409901|"     This randomized controlled trial (RCT) will examine the effect of a novel 12 month     personalized exercise rehabilitation program compared to standard care following kidney     transplantation. Return to work or find work rates, markers of subclinical atherosclerosis,     functional capacity, body composition, quality of life, kidney function, and adherence to     exercise will be measured. The investigators' primary hypothesis is that a 12 month exercise     rehabilitation program will increase the return to work or find work rate in kidney     transplant recipients. The investigators additionally hypothesize that a 12 month exercise     rehabilitation program will prevent a decline in subclinical atherosclerosis, increase     functional capacity, and increase lean muscle mass.   "
66914|NCT02409888|"     The purpose of this study is to investigate how behavioral treatments for alcohol use     disorders affect behavior change.   "
66915|NCT02409875|"     This is a cohort study where families with infants are followed closely for three years. It     aims to assess if parental weight status (normal weight vs. overweight/obesity), their     physical activity and eating habit will influence their young children's growth and be     helpful in childhood obesity reducing.   "
66919|NCT02409823|"     Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been     found to be effective and safe for the treatment of schizophrenia, bipolar disorders,     depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of     Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at     the time that interact with serotoninergic, adrenergic and histaminergic receptors, among     others. Quetiapine extended-release has the same clinical efficacy as the immediate-release     formulation, but reduces the amount of daily doses, possibly contributing to increased     treatment adherence.      The purpose of this registry is to explore adherence to treatment, the occurrence of adverse     drug reactions and the clinical outcomes in a sample of patients under treatment with     atypical antipsychotics in several Central American countries. For this study, clinical data     will be extracted from the medical records of 1000 patients with schizophrenia, depressive     disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions,     namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic     hypotension; adherence to treatment; and changes in quality of life and clinical status will     be assessed during the first 8 weeks of treatment.   "
67006|NCT02408692|"     The purpose of this research study is to determine how body weight changes the drug level of     an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This     emergency contraceptive is available to women without a prescription, but has recently been     found to not work as well to prevent pregnancies in women of higher body weight. The overall     goal of this research is to improve the effectiveness of contraception for women, no matter     their weight.   "
67007|NCT02408679|"     The purpose of this clinical study is to evaluate the metrological properties of a     questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood     dosage.   "
66920|NCT02409810|"     The primary aim of this pilot study is to establish the safety and feasibility of     patient-controlled administration with dexmedetomidine for anxiolysis (PCA-DEX) during burn     care dressings for patients with burn injury. The secondary aim is to determine the     acceptability of PCA-DEX for anxiety symptom management by patients with burn injury and     nursing staff caring for these patients. Objectives Primary Aim #1 Safety: To examine the     safety of PCA-DEX as determined by the proportion of patients successfully completing the     pilot trial without adverse effect which include significant hypotension, bradycardia, or     agitation from uncontrolled anxiety. Primary Aim #2 Feasibility: The primary objective of     this study is to establish feasibility of subject recruitment and protocol adherence in a     pilot study of PCA-DEX in patients with burn injury requiring dressing changes. Feasibility     will be defined by the following criteria: a) number and proportion of patients who consent     to enrollment, b) proportion of eligible subjects enrolled prior to first dressing change, c)     number of days on protocol that patients successfully use the PCS device, d) ability of burn     nurses to adjust the pump and adhere to the infusion rates of the PCA-DEX protocol. Secondary     Aim #1 Patient Acceptability: A secondary objective of this pilot study is to have patients     evaluate PCA-DEX in regards to patients' willingness to use PCA-DEX prior to and during burn     dressing changes to self-manage anxiety and their satisfaction ratings with anxiety     self-management. Secondary Aim #2 Nurse Acceptability: Another secondary aim of this pilot     study is to evaluate the nursing staffs' acceptability of the PCA-DEX protocol for patients'     to self-manage anxiety surrounding burn care dressing changes. Hypotheses #1: PCA-DEX     protocol will be safe to administer during burn care dressing changes. #2: PCA-DEX will be     feasible to implement on the Burn Center at OSUWMC. #3: Patients will favorably appraise     PCA-DEX for the self-control of anxiety associated with burn care dressing changes, and be     satisfied with PCA-DEX for the management of anxiety. #4: Nursing Staff will favorably     appraise PCA-DEX while performing burn care dressing changes.   "
66921|NCT02409797|"     The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during     the delivery of a specific, manually based chiropractic treatment for participants with low     back pain.   "
66922|NCT02409784|"     Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of     aging-related cognitive impairment in humans. Ketones are the main alternative energy     substrate to glucose for the brain. Several studies show that brain ketone uptake and     metabolism are unaltered in cognitively-normal older persons and in Alzheimer's disease (AD).     Nutritional ketosis is reported to have a positive impact on cognitive performances in mild     cognitive impairment and AD. Nevertheless, changes in regional brain glucose and ketone     uptake in adults are poorly understood during diet-induced experimental ketosis. The     investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be     directly correlated with the elevation of blood ketone levels and inversely correlated to     brain glucose uptake.   "
66923|NCT02409771|"     The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON     Presbyopic.   "
66924|NCT02409758|"     The purpose of this study is to evaluate the effectiveness and safety of the Comprehensive     Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia.   "
66925|NCT02409745|"     Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate     in patients undergoing in vitro fertilization and embryo transfer. However, only a limited     number of studies have been conducted in frozen thawed transfer (FET) cycle. Nowadays, in FET     cycles, endometrial scratch is mainly performed on two different time points: 1) luteal phase     in the previous cycle; 2)early follicular phase in the current cycle. However, few studies     have compared the effectiveness of those two different endometrial scratch methods performed     in different timing. The aim of this study is to find the best timing of endometrial scratch     in FET cycles.   "
66926|NCT02409732|"     To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the     treatment of actinic cheilitis.   "
66927|NCT02409719|"     The investigators include patients attending the outpatient clinic in the area of Orthopedics     and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which     treatment requires surgery. Patients will be divided into two groups. In both groups, they     will be given verbal, clear and detailed information on the approach to follow, the exercises     given in brochures, and in the study group a schedule will be given in order to record     rehabilitation exercises in patients after total knee replacement (TKA). Both groups will be     assessed before and after surgery, together with outpatient follow-up by, WOMAC, Visual     Analogue Scale and SF-12.   "
66928|NCT02409706|"     This study aims to explore the frequency and types of micronutrient deficiencies in a sample     of UK children with CHD using standard and novel markers in blood. The study will also     explore whether micronutrient deficiencies increase the risk of complications after heart     surgery. This study will identify any nutrient deficiencies that need monitoring in clinical     practice.   "
66929|NCT02409693|"     This is a retrospective chart review. The purpose of this study is to retrospectively examine     the use of perioperative analgesics on the incidence of postoperative pain and emergence     delirium in patients undergoing bilateral myringotomy with tube insertion (BTI), as well as     events associated with treatment including postoperative vomiting and time to discharge.   "
66930|NCT02409680|"     Available data suggest that low dose aspirin may be a safe, widely available and inexpensive     intervention that may significantly reduce the risk of preterm birth. However, this     possibility needs to be proven in a properly designed randomized controlled trial (RCT) with     preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and     geographically diverse population could best be accomplished by the established     infrastructure of the Global Network for Women's and Children's Health Research (GN).   "
66931|NCT02409667|"     To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg     s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c.     every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.   "
66932|NCT02409654|"     Stroke is a leading cause of mortality, morbidity and rising healthcare cost worldwide. In     'real-world' practice, AF is often diagnosed too late at time of stroke and detection can be     difficult because AF may be present without symptoms and intermittent in nature. Furthermore,     utilization of adequate oral anticoagulation therapy (OAC) for stroke prevention is     suboptimal in Hong Kong. The challenge is to identify AF prior to occurrence of stroke. The     latest European guidelines recommend opportunistic screening for people >=65 years by pulse     palpation followed by 12-lead ECG. However, 12-lead ECG requires a trained technician, time     consuming, requires the patient to lie on an examination couch and is not readily available     in most outpatient clinics in Hong Kong. A practical screening test is needed. Our study aims     to evaluate the feasibility, acceptability and incremental cost of an outpatient based     AFscreening program using the AliveCor device. Newly diagnosed AF patients will be randomized     to routine care versus individualized stroke prevention strategy which consists of patient     education, stroke and bleeding risk assessment, evidence-based OAC recommendation, patient     audit and follow-up to improve OAC utilization for stroke prevention. We envisage this study     will provide timely evidence to inform policy decisions concerning population-based     AF-screening for AF for stroke prevention.   "
66933|NCT02409641|"     The WHO, states that age related cataracts account for 51 percent of worldwide blindness and     affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the first     line treatment for cataracts, thus there is an on going effort to improve IOL design and     performance.      It is planned to compare three different IOL designs in a psychophysical test setting. Most     IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study     (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow     testing a more real-life situation.      As various downsides of different IOL designs have been reported, testing of IOLs before     surgical implantation is a promising approach to maximise patient satisfaction. Known     deficiencies include amongst others reduced contrast sensitivity or light intensity.      To test three different IOL designs, it is planned to have 2D healthy young subjects look     through a stable, table mounted spectacle frame, in which the different IOLs can be inserted.     This allows for subjective testing of IOL's in a 2D and 3D scenario.   "
66934|NCT02409628|"     The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair     Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical     removal of non-melanoma skin cancers.      EktoTherix™ is a medical device developed by Neotherix Limited, manufactured by the polymer     processing technique of electrospinning. Described as a tissue scaffold, EktoTherix is     placed into the surgical wound to help the patients' own cells repair the wound, enhancing     healing and improving quality (including cosmetic outcome). The tissue scaffold is completely     absorbed by the body during the healing process, which means that there is no need to remove     it when the wound is healed.      All patients recruited into this study are treated with EktoTherix, are seen weekly until     they heal and seen again at the final follow-up visit three months post-surgery.      The investigators hypothesise that the use of EktoTherix will increase incidence of complete     healing and result in an overall better cosmetic result of the healed wound.   "
66935|NCT02409615|"     In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing     touch as adjunct therapies to the standard of care, will improve analgesic use for post     operative pain. In this pilot study the investigators will randomize 45 adolescents     undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain     Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of     Care, and a control group (Pain Management Standard of Care only).   "
66936|NCT02409602|"     Dorsal clitoral artery Doppler examinations in women with bilateral internal iliac artery     ligation due to postpartum hemorrhage (study group) and age-matched healthy puerperal women     were performed regularly in the postoperative period, in order to evaluate possible effects     of BIIAL on clitoral blood flow.   "
66937|NCT02409589|"     The purpose of this study is to compare a new intracavitary ECG guiding method for real-time     positioning the tip of three-way valve type peripherally inserted central catheters versus     conventional surface prediction length method in terms of single-time target rate.   "
66938|NCT02409576|"     Progress in the treatment of children with leukemia and lymphoma results in high cure rates     but progress in the treatment of children and adolescents with solid tumors has been slow.     Despite aggressive therapy with multimodality treatment involving surgery, radiation and     chemotherapy, about two thirds of the patients with metastatic Ewing sarcoma (EWS),     metastatic osteosarcoma (OS) and intermediate and high risk rhabdomyosarcoma (RMS) will     relapse. The available second line therapies for relapse are limited and often not effective.     There is a dire need to look for treatment options beyond conventional means for the     treatment of these patients.      Infusions of allogeneic natural killer (NK) cells in leukemia patients have shown to be     tolerated well without inducing graft versus host disease (GVHD). There is also mounting     evidence that NK cells have activity against solid tumors.      In the lab the investigators tested NK cell activity against cell lines from different     paediatric solid tumors. Among paediatric solid tumors, EWS and RMS are exquisitely sensitive     to killing by expanded NK cells; NK cells also have activity against OS cells. Preliminary     clinical data suggest that donor NK cells may exert antitumor activity in children with solid     tumors undergoing allogeneic hematopoietic stem cell transplantation.      Taking into account the safety of adaptive NK cell infusion, and their efficacy against EWS,     RMS and OS, NK cells could be a powerful new tool in the treatment of paediatric solid     tumors.      The great anti-tumor activity of expanded and activated NK cells, together with the     feasibility of infusing haploidentical NK cells in a non-transplant setting form a compelling     rationale for the clinical testing of these NK cells in patients with sarcoma.   "
66939|NCT02409563|"     In clinical trials for treatment of allergic rhinitis a significant reduction of the total     symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous     results in adults show that the assessment and monitoring del nasal fractional exhaled nitric     oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis.      Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous     solution) on the nasal inflammation marker (nFeNO).      Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom     Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep     quality (Pittsburgh Sleep Quality Index, PSQI).   "
66940|NCT02409550|"     This project is an observational study for the Italian language validation of the CARATKids     questionnaire investigating the asthma and coexisting allergic rhinitis control in children.     113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months     will be enrolled for the validation process at outpatient clinic of Pediatric Allergology &     Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of     Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo     (RDRC-IBIM CNR), Italy.      The study will be completed in two medical examination, within 3-6 weeks of each other.      CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test)     will be filled by each patient.      The main outcome is the Italian language validation of the CARATKids questionnaire     investigating the coexisting asthma and allergic rhinitis control in children.   "
67053|NCT02408068|"     The purpose of the study is to find out whether food has an effect on the way the body deals     with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate     release hydrocortisone (fasted). This information will be used to help doctors with dosing in     clinical practice.   "
66941|NCT02409537|"     Background & Aims: The role of red wine in cardiovascular risk prevention has been documented     by several epidemiological studies in patients and normocholesterolemic healthy individuals.     However, it is unclear whether hypercholesterolemic individuals free of cardiovascular     disease would equally benefit from moderate red wine consumption to prevent atherosclerosis     and the development of cardiovascular disease.      Methods: Forty (40) healthy volunteers males and females were recruited, divided into 2     age-adjusted groups according to their total cholesterol levels; in asymptomatic     hypercholesterolemics (AHC ), and normocholesterolemics (NC ). Total Antioxidant Capacity     (TAC ), Lipid profile, Vitamin E, and cardiovascular risk indexes ( LDL /HDL and Vitamin E/TC     ) were evaluated in the blood serum of all subjects prior to and 1 month after once daily red     wine consumption as well as prior to and after being given a placebo drink following a 1     month wash out period and resveratrol for 1 month after wash out period..   "
66942|NCT02409524|"     This is an open-label, single site, Phase II clinical trial to investigate the safety and     efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients     after a minimum of 90 days on sorafenib.   "
66943|NCT02409511|"     Microalbuminuria (MA) is an independent cardiovascular risk factor in diabetic and     non-diabetic subjects.      However, in the setting of type 2 diabetes, microalbuminuria could be a marker of either     early diabetic nephropathy or diffuse endothelial dysfunction. At present, there are no     biomarkers that permit us to discriminate between these two conditions.   "
66944|NCT02409498|"     The purpose of this study is to determine the effectiveness of perineal pain control via     injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly     used for this block is called marcaine. This is called a pudendal block it has been used in     obstetrical and gynecologic surgeries for several decades. The goal of this study is to     reduce the amount of pain medications taken post operatively after pelvic reconstructive     surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the     pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to     document their pain score days 1 and 2 post op. They will also be asked to keep a medication     log for 14 days post op.   "
66945|NCT02409485|"     By teaching skills to improve the coordination of care and support in couples coping with     head and neck cancer (HNC), this couple-based psychosocial intervention holds great promise     for improving self-management, reducing costly hospitalizations and treatment interruptions,     and improving both partners' quality of life. Home-based delivery will enhance future     dissemination and outreach to those who do not have access to psychosocial services or live     far away from their care centers. If found effective, the intervention may also have salutary     downstream effects on the health and well-being of HNC patients and their partners.   "
66946|NCT02409472|"     Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their     front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible for     the trial and randomized to two different surveillance programs. These programs differ     greatly in the frequency of diagnostic imaging. They have similar schedules of physical     examinations and carcinoembryonic antigen (CEA) assessments. Patients will receive baseline     and yearly health-related quality of life (HR-QoL) questionnaires. Primary outcomes are     overall survival and QoL.   "
66947|NCT02409459|"     This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of     iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1     ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed     for efficacy and safety for 42 days.   "
66948|NCT02409446|"     The purpose of this study is to examine weather treatment with anthocyanins will affect lipid     profile, markers of inflammation and oxidative stress in addition to antioxidative level in     serum to the better in persons with increased risk of dementia.      The purpose of this study is to examine weather treatment with anthocyanins will increase the     score of relevant tests of cognitive function.      The investigators will do an open pilot study where patients receive anthocyanin for 16     weeks. 34 patients are expected to be included.      In addition we will include 20 healthy Controls.   "
66949|NCT02409433|"     The Investigator plans to perform a prospective, randomized, single blinded, study that will     compare patients treated with IV lacosamide to those treated with Phenytoin in the Intensive     Care Unit (ICU) setting. The investigator will also evaluate the rate of clinically evident     and sub-clinical seizures, and to compare long-term outcomes between patients treated with     lacosamide and those treated with Phenytoin.   "
66988|NCT02408926|"     Young infants are most vulnerable to severe disease and even death when infected with     Bordetella pertussis. The current vaccines and vaccination programs do not guarantee     protection of neonates from this disease. Maternal acquired pertussis-specific antibodies     show low concentrations with short persistence in newborns creating a susceptibility gap for     infection between birth and the first vaccinations. A possible strategy to protect infants     from birth is pertussis vaccination during pregnancy, which will increase the amount of     passively transferred maternal antibodies.      However, little is known regarding the effect of high titers of maternal antibodies on the     infants immune responses to different pertussis vaccines (whole cell versus acellular).     Humoral immune responses will be assessed in infants receiving whole cell versus infants     receiving acellular pertussis vaccines. Functionality of the antibodies will also be     analyzed.   "
74923|NCT02305082|"     The implementation of an enhanced recovery pathway after giant ventral hernia repair,     including preoperative high-dose steroid is examined prospectively and compared with a group     of historic controls.   "
67054|NCT02408055|"     A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled     TA-8995 (10mg) in healthy male subjects.   "
67055|NCT02408042|"     To determine the recommended phase 2 dose of chemotherapy in combination with Pembrolizumab     in subjects with advanced lymphoma and determine the complete response rate.   "
67056|NCT02408029|"     This study is being performed to obtain data about the CORA System when used in a trauma     clinical setting. The CORA analyzer is a new device that is currently being tested in trauma     clinical applications and is not yet cleared for this purpose by the Food and Drug     Administration (FDA) for sale in the United States.   "
66950|NCT02409420|"     Chronic low back pain (CLBP) is very common and causes much pain and disability. It costs the     NHS billions of pounds in treatment every year and is the second leading cause of time off     work. There are various treatments for CLBP, but the most effective are still only moderately     helpful. Most people with CLBP receive physiotherapy, with varying results. Cognitive     behaviour therapy (CBT) may offer more long term help than current treatments because it     enables people to self-manage their condition. A new type of CBT, called Acceptance and     Commitment Therapy (ACT), has produced particularly good results for chronic pain. However, a     shortage of clinical psychologists means that most patients never receive CBT.     Physiotherapists can successfully use CBT techniques with extra training, but this is not     standard practice and ACT-based physiotherapy treatment has never been tested.      The investigators have developed a short ACT-based treatment (PACT) for physiotherapists to     deliver and aim to compare it with usual physiotherapy care. The investigators will recruit     240 people with CLBP from three hospitals in South East London. They will be randomly divided     into two groups, with half receiving PACT and the other half ordinary physiotherapy. PACT     consists of two hour long sessions and one follow-up phone call, meaning fewer hospital     visits for patients and more time during sessions for individualised treatment. It aims to     encourage people to focus less on getting rid of their pain and more on moving forward with     what is most important in their lives. The investigators will compare PACT with usual     physiotherapy to see which is most successful at improving people's ability to function and     their quality of life and which approach helps them to manage their back pain best in the     long term. If PACT is effective, the investigators believe it could reduce the considerable     burden of CLBP to patients, the NHS and society.   "
66951|NCT02409407|"     The role of hysteroscopy in infertility investigation is to detect possible intrauterine     changes that could interfere with implantation or growth or both of the conceptus, with the     invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office     setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention.     It is currently acknowledged as the 'gold standard' investigation of the intrauterine     abnormalities.      Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force     needed for dilation, thereby potentially reducing the probability of procedural complication     such as uterine perforation, cervical laceration, failure to dilate, and creation of a false     track that can occur during cervical entry.      Misoprostol is a prostaglandin El analogue, that can be administered either orally or     vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis     of proteoglycans.   "
66952|NCT02409394|"     This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag     fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on     the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.   "
66953|NCT02409381|"     Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two     hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be     randomly allocated to one of two treatment groups , and treatment group 01 will be the dried     extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02     will ibuprofen (Alivium®).   "
66955|NCT02409355|"     This randomized, open-label study is designed to evaluate and compare the safety and efficacy     of atezolizumab with gemcitabine + cisplatin or carboplatin in participants with     chemotherapy-naive, Stage IV squamous NSCLC.   "
66956|NCT02409342|"     This randomized, open-label study will evaluate the efficacy and safety of atezolizumab     compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per     investigator discretion) combined with either pemetrexed (non-squamous disease) or     gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected,     chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.   "
66957|NCT02409329|"     This study evaluates a mobile phone-delivered intervention, called REACH (Rapid     Education/Encouragement And Communications for Health), in supporting adults with type 2     diabetes in their self-management relative to a control group. The goal of this study is to     determine if individually tailored content (based on the Information-Motivation-Behavioral     Skills Model) delivered to the participant via text messages can improve the participant's     glycemic control and adherence to diabetes medications. We will test whether our intervention     improves adherence-related information, motivation, and behavioral skills and whether     improving these mechanisms drives improvements in adherence and, in turn, glycemic control.   "
66958|NCT02409316|"     In this study, positron emission tomography (PET/CT) imaging will be used to evaluate     estrogen receptor (ER) activity in sites of metastatic disease using the investigational     radiotracer [18F]fluoroestradiol (FES).   "
66959|NCT02409303|"     This project will implement and evaluate an innovative healthcare service delivery model     designed to promote earlier access to specialized intervention for toddlers with ASD. The     Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early     identification and intervention by involving both medical and EI providers, and represents a     practical and sustainable strategy for bridging the gap between ASD concerns and ASD     intervention.   "
66960|NCT02409290|"     Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected     person transmits their saliva through the air by coughing or sneezing. Despite the     availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the     worldwide control of this disease is currently being impacted by the emergence of multidrug     resistant TB (MDR-TB).      MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two     most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a     person is taking TB treatment due to either inappropriate treatment or failure of patients to     comply with their treatment. This strain of drug-resistant bacteria can also be spread to     other people through the air.      MDR-TB leads to a considerable reduction in the effectiveness of standard short-length     treatments and currently the standard treatments for MDR-TB can last as long as 24 months.     With the incident rate of MDR-TB on the rise (511,000 new cases in 2007) and the lengthy     duration of current treatments there is a need to investigate whether a shorter-length     treatment using effective drugs is a global possibility.      Three short course regimens of drugs will be evaluated alongside the World Health     Organisation recommended 24 month regimen for the treatment of MDR-TB.      A total of at least 1155 participants with MDR-TB will be recruited and followed for a total     of 132 weeks.   "
75301|NCT02300155|"     The purpose of this study is to compare the tolerability of Pregvit® to a common prenatal     vitamin (Orifer® F) among pregnant women with morning sickness or those suffering from a     variety of conditions.   "
67187|NCT02406313|"     The study evaluates the efficiency, in terms of quality of life improvement, of a patient's     therapeutic education program (ETP), based on long term commitment in adapted physical     activities carried out during a standardized thermal cure (CTS) for fibromyalgia among     patients continuing regular drug treatment or not   "
66961|NCT02409277|"     The investigators have developed a tool to facilitate asthma self-management in children, the     electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new     model that is continuous and proactive, focusing on prevention and control, rather than     reactive and focusing on management of asthma attacks. The e-AT 1) engages parents in weekly     monitoring of their child's chronic asthma symptoms, 2) guides parents to recognize warning     signs of asthma attacks in order to prompt appropriate interventions and timely visits to     Primary Care Providers, and 3) provides Primary Care Providers with real-time, objective     patient data to assess the effectiveness of asthma therapy and prompt adjustments. In a     preliminary study of the paper-based version of the AT, frequent users had significantly     fewer emergency department (ED) and hospital visits. Parent comments during the e-AT pilot     testing revealed that the tool was useful in helping them manage their child's asthma and     were interested in assessing the tool's effectiveness and in identifying and addressing     barriers to their sustained use of the e-AT.      Improving asthma control in children will be facilitated by broad e-AT dissemination, and by     identifying and addressing critical factors that contribute to parent sustained participation     in self-management. The investigators propose to assess the effectiveness of the new     ambulatory care model supported by the e-AT and conduct an e-AT process evaluation, assessing     barriers and facilitators of sustained parent use. The investigators will engage parents     throughout this study to identify and address themes that matter to them. The target     population is children with persistent asthma, ages 2-17 years. The investigators have     engaged 10 parents since conception of this project, from the planning to design and     validation of the paper-AT, and the design and pilot testing of the e-AT. Input from parents     was received through 3 iterative focus groups (one for the paper-AT and 2 for the e-AT) and     facilitated discussions to inform the development of this proposal including research     objectives and outcome measures. In addition, the investigators have recruited other key     stakeholders for whom the results of the research will be relevant.   "
66962|NCT02409264|"     In South Africa, 27% of adult males and 31% of adult females experience insomnia. Insomnia     may lead to feelings of fatigue and sleepiness, mood disturbances, cognitive difficulties,     and may exacerbate symptomatology of co-morbid diseases. Current conventional treatment for     insomnia includes both psychological and drug therapies. These conventional medications     potentially may lead to dependency and withdrawal symptoms. Individualised homeopathic     treatment is a process in which a homeopath selects the most appropriate remedy for the     treatment of a condition in accordance with the fundamental principles of homeopathy. This     treatment protocol may offer safe and effective treatment for insomnia disorder, however,     more research is required on the subject. The aim of this study is to determine the effect of     individualised homeopathic treatment of insomnia disorder in females using detailed case     studies and the Insomnia Severity Index.   "
66963|NCT02409251|"     The aim of this study is to assess the effect of a simple intervention (a combination of     education and feedback) on Antinuclear Antibody (ANA) testing.      This aim was chosen because of the known overuse of many laboratory tests, of which ANA     testing is one. As overuse of ANA tests can have negative consequences (both for patients and     society), the investigators designed an intervention to see how this would influence     Antinuclear Antibody testing by rheumatologists.   "
66964|NCT02409238|"     Dementia (Alzheimer's Disease) is sometimes called Type 3 Diabetes because of the strong     connection between Type 2 diabetes (a function of insulin resistance) with Dementia.      The investigators therefore hypothesize that Reducing Insulin Resistance using Intensive     Lifestyle Intervention (Exercise and Weight loss) + Metformin Treatment in Prediabetic &     diet-control-only Diabetic overweight and mildly cognitively impaired individuals 55 years or     older would lead to better Cognitive Function (compared to standard care) after 2 years.      Subjects will be monitored and assessed using a battery of Cognitive and psychological tests     and PET scans to demonstrate glucose utilization in the relevant areas of the brain.      This 3-year open-label study aims to recruit 360 subjects with 50% (180 subjects) randomized     to receiving Intensive lifestyle intervention with Metformin (if diabetic) vs the other 50%     who would receive only the usual standard level of care in the primary care setting.   "
66965|NCT02409225|"     Purpose: Home monitoring (HM) services supplied by different manufacturers (St Jude Medical,     Biotronik, Medtronic) enables trained medical staff (doctors, electrophysiology nurses and     technicians) to safely follow-up patients with implanted ICD/CRT-D remotely, with omitting     unnecessary visits in outpatient clinic, shortening time to medical intervention and     therefore help to decrease hospitalization rate among those patients.      The RESULT study primary endpoint of the trial will be a composite of all-cause death or     hospitalization due to cardiovascular reasons.      The primary technical endpoint is to construct and evaluate a unified and integrated platform     for data collected from RM devices manufactured by different companies: Carelink™     (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home     Monitoring™ (Biotronik®, Berlin, Germany).   "
66966|NCT02409212|"     Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1)     comparing an aerobic exercise training intervention to usual care plus exercise advice. The     primary outcome is the feasibility of the intervention as novel primary therapy in men with     localised prostate cancer.   "
66967|NCT02409199|"     This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared     to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial,     patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm     B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to     RECIST 1.1. The primary endpoint is progression free survival (PFS).   "
66968|NCT02409186|"     Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2     decades, well-designed clinical trials have documented the clinical benefits of combination     of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or     in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent     activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the     recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of     esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor     Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR     expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both     normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor     (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models     have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our     phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination     of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits.     Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe     and provided statistically significant objective response (47.8%) and disease control rate     (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III     trial.   "
75870|NCT02292745|"     The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and     stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an     increase in survival.   "
66969|NCT02409173|"     Obesity is currently one of the most serious public health problems. Its prevalence is     increasing sharply in recent decades, even in developing countries, leading to global     epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and     cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and     hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical     condition in more than 60% patients with MS. It is still controversial in the world     scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation     (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively     reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will     reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of     severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To     investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers,     sleep, pulmonary function, BMI reduction and health related quality of life in severe obese     patients with and without metabolic syndrome undergone to bariatric surgery.   "
66970|NCT02409160|"     Obesity is a major public health problem in developed and developing countries, causing a     range of respiratory and metabolic changes. There is a strong correlation between obesity and     cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and improves the     quality of life, but clinical treatment it is not effective for a long period. In this     context, currently bariatric surgery is an option for the real weight loss in the long term.     Obstructive sleep apnea (OSA) is a common clinical condition observed in patients with     obesity. The primary aim of this protocol are to assess the inflammatory profile of severe     obese patients undergone to bariatric surgery, through systemic and adipose markers of     inflammation. A secondary objective is study the impact of this surgery on sleep variables     and quality of life. Investigators hypothesized that weight loss induced by bariatric surgery     reduces systemic inflammatory profile, improve sleep quality and quality of life of subjects     with severe obesity. Will participate in this study, patients with severe obesity (BMI > 40     or 35 to 39.9 kg/m2 associated comorbidities), with indication of bariatric surgery, screened     Bariatric Surgery Service of Santa Casa de São Paulo in São Paulo. Inclusion criteria are     severely obese, bariatric surgery indication and agreement to participate in the study. Are     excluded patients with BMI > 55 kg/m2, clinical instability, mental instability or     significant and unrealistic expectations of surgery. Patients will be assessed before and     after bariatric surgery, 90, 180 and 360 days. The evaluation protocol will consist of     clinical history, vital signs, neck and waist circumference, clinical analysis of blood     inflammatory markers, lung function tests, maximal ventilatory pressures, full overnight     standard polysomnography, excessive daytime sleepiness scale, cardiovascular risk, quality of     life and personal satisfaction questionnaires.   "
66971|NCT02409147|"     This study will explore the feasibility of initiating a uterine transplant program at UNMC.     Using the procedural templates established by a successful Swedish team, the investigators     will identify emotionally and socially stable females of reproductive age with intact ovaries     who are unable to gestate a child due to congenital or acquired uterine factor infertility     (UFI). Women will be 21 to 35 years of age upon entry into the protocol, with normal ovarian     reserve and otherwise healthy for pregnancy. After careful screening, participants will     undergo egg harvest, in-vitro fertilization, and embryo cryopreservation using standard     methods. Women who successfully complete in vitro fertilization and cryopreservation of at     least six embryos will be eligible to receive implantation of a deceased donor uterus. After     a period of observation to ensure normal menstrual cycling and graft viability, embryo     implantation will be undertaken. Gestations will be carefully monitored by our high-risk     pregnancy specialists. Medical research interventions include uterine harvest from a deceased     donor, surgical implantation of the organ utilizing standard transplant techniques, careful     post-transplant follow-up including immune suppression therapy tailored to minimize fetal     compromise, and careful management of pregnancy. After childbearing is complete (at most two     gestations), the donor uterus will be removed. In addition, open-ended interviews and written     surveys will be conducted to elicit ethical and psychosocial concerns arising from the     experience of subjects and their families, health care providers, and the wider community.     The investigators intent is to monitor outcomes lifelong for transplant recipients and     live-born infants.   "
66972|NCT02409134|"     Psychological well-being and cognitive function will be measured in patients enrolled on the     primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to     prevent graft versus host disease following unrelated donor hematopoietic stem cell     transplantation. Validated questionnaires will be administered to assess patients' level of     depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality.     Cognitive testing will include reliable and valid measures of processing speed, attention,     executive function, episodic memory, and visual learning and memory. The purpose of this     study is to determine whether these measures are feasible to administer in patients before     and at early time points after bone marrow transplantation .   "
66973|NCT02409121|"     Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow     transplantation (BMT), is a potentially life-saving therapy for many malignant and     non-malignant conditions. Despite advances over the past decade, which have led to improved     outcomes, BMT remains an intense treatment modality often requiring prolonged inpatient-based     care. While many patients endure the acute complications of the procedure, it is common for     BMT patients and their caregivers to experience increased risk of financial and emotional     burden, hospital readmission, and health service utilization. This highlights the importance     of active involvement of BMT patients in their own health care (self-efficacy). For pediatric     BMT patients, parents are the primary caregivers. As such, parental activation on behalf of     the child (patient) plays a critical role in effective patient-parent-provider partnerships,     which is increasingly recognized as the optimal model for health care delivery, particularly     for those facing life-altering medical treatments. It is essential to develop effective     strategies to enhance this partnership. Health information technology (IT)-mediated tools     offer the potential to overcome constraints in health care delivery limited by provider time,     complicated health information, and financial pressures. Significant gaps in knowledge exist     on the use of health IT tools using low-cost and well-accepted delivery platforms in routine     inpatient care, especially for high-risk or critically ill populations. The investigators     hypothesize that a tablet-based tool displaying personal health information could provide a     platform to promote caregiver (parent) activation and enhance health communication. In this     clinical research study, the investigators will conduct a pilot study of an educational     health IT system developed on a tablet (Apple iPad®) that the investigators refer to as a     Personalized Engagement Tool (PET) or the BMT Roadmap. The Apple iPad® was selected as the     platform for delivery of the educational intervention given its ergonomic features. The     implementation and evaluation of the BMT Roadmap information system in caregivers of children     undergoing BMT have been based on the generation of user (caregivers and patients) needs that     incorporated well-established user-centered design processes including qualitative and     quantitative research methods (published and unpublished data). The assembled investigators     represent a strong multidisciplinary team with complementary and integrated expertise who are     well-poised to carry out the proposed research. The Protocol or Study Team includes pediatric     BMT physicians, Center for Health Communications Research (CHCR) staff, health informaticist,     biostatistician, and psychologist. This research study is innovative because it addresses a     gap in the literature on the role of health IT in parent activation on behalf of the child in     the inpatient setting of a high-risk BMT population. The BMT Roadmap information system     provides a robust experimental framework for further testing the utility of other care     components that relate to parent activation or participation and for potential adoption in     other complex medical conditions. The new knowledge gained herein will thus contribute to the     evidence base of how health IT improves health care quality and provide the basis of further     study in a full-scale clinical trial.   "
66974|NCT02409108|"     The purpose of this study is to gather information on how safe the hyperthermia treatment     delivered via the Exatherm-TBH (the device that will heat your blood and deliver it back to     you), added to the best supportive care is to patients who have advanced persistent or     recurrent, unresectable Non Small Cell Lung Cancer.   "
66975|NCT02409095|"     This is a study planned to determine and compare immunogenicity and reactogenicity of     DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or     disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of     enrollment.      It will provide information to aid managers, device regulatory control officials,     immunization programs, and clinicians who make decisions on safe clinical practice standards.   "
66976|NCT02409082|"     The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma     to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is     performed prior to operation. Blood samples and CSF samples are collected at surgery and     blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days, 3     months and 1 year. Morbidity is assessed at , 3 months and >1 year. Neuromarkers specifically     addressing the inflammatory component are to be analyzed and correlated to outcome together     with AD markers, as above.   "
66995|NCT02408835|"     This study investigates the use of a negative pressure wound therapy device (PICO™, Smith &     Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing     inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.   "
67194|NCT02406222|"     This study is determining whether the addition of cyclophosphamide to pomalidomide and     dexamethasone improves progression free survival in patients with relapsed refractory myeloma     (RRMM) compare to pomalidomide and dexamethasone alone. Patients will be randomised on a 1:1     basis to receive CPD or Pd. Treatment will be continued until disease progression or     unacceptable toxicity.   "
66977|NCT02409069|"     The goal of this study is to investigate the influence of transcutaneous vagus nerve     stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy     volunteers.      Preclinical and clinical studies indicate that noradrenaline plays a role in the working     mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive     vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.      The release of noradrenaline in the brain will be measured non-invasively by the P300     component of event-related potentials in the electro-encephalogram (EEG) via an auditory     oddball paradigm.      Research to elucidate the working mechanism of non-invasive neurostimulation can help to     identify subpopulations who will respond well to a treatment and can provide insights that     could contribute to the optimalisation of the stimulation parameters, with as possible     consequence a better clinical outcome.      Some studies indicate that stimulation of the vagus nerve can optimally influence memory,     possibly via the noradrenergic system. This study will investigate if the effects of invasive     vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve     stimulation.      The influence of transcutaneous vagus nerve stimulation on memory will be measured via a     neuropsychological memory task that investigates the ability to focus attention. The     correlation between the performance on the memory task and the signal analysis of the     auditory oddball task could give an indication about the underlying working mechanism of     transcutaneous vagus nerve stimulation on memory.      This will be the first step to investigate whether transcutaneous vagus nerve stimulation can     be used as innovative intervention for cognitive decline.   "
66978|NCT02409056|"     This project is the test of the effectiveness of the Chronic Disease Self-Management Program     which will be translated to a worksite setting.   "
66979|NCT02409043|"     The purpose of this research study is to determine if there are molecules in the blood that     indicate when a person has had a stroke, and what type of stroke they have had, so that     appropriate treatment may be begun as soon as possible. This study is also being conducted to     determine whether these molecules can help to predict long-term health following stroke. Some     of these potential molecules, also called biomarkers, include Neuronal biomarker ubiquitin     C-terminal hydrolase-L1 (UCH-L1), Glial markers such as glial fibrillary acidic protein     (GFAP), and a neuroprotective enzyme called angiotensin converting enzyme 2 (ACE2), which has     activity that has been shown to be helpful cardiovascular disease and shown to be altered in     animal models of acute stroke, where it is also shown to provide neuronal protection.   "
66980|NCT02409030|"     The purpose of this study is to validate a diagnostic test that combines different blood     markers to identify and correctly classify patients with Alzheimer's disease (AD) compared to     individuals with behavioural variant frontotemporal dementia (bvFTD, patient control) versus     cognitively healthy individuals (healthy control).   "
66981|NCT02409017|"     To assess which of two commonly utilized insulin drip protocols has better outcomes when used     during the labor process.   "
66982|NCT02409004|"     This will be a single centre, Phase I, open-label, one cohort, one dose level,     fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is     to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting     conditions.   "
66983|NCT02408991|"     The purpose of this study is to measure the concentration of cells and proteins in the     patient's blood during administration of Nuopogen (Filgrastim), a medication that is FDA     approved for stem cell mobilization, in combination with a programmed pneumatic compression     device (PPCD) (Art-Assist Device). The Art-Assist Device is an FDA approved device that     promotes blood flow in the patient's legs. A patient will be prescribed this device and this     drug to help improve the poor circulation in his/her leg. The use of Nuopogen along with the     Art-Assist Device has not been approved by the FDA and is considered experimental.      This study is not designed to find out how well the Art-Assist Device works, nor how well the     drug works in mobilizing stem cells. Instead, it is a study of how well cells lining blood     vessels in calf respond to increases in shear stress, and how well the increase in the     population of certain cells in the blood stream effect how the new blood vessels will form.     It is important for clinical reasons, and for the purposes of this study, that the patient     uses the Art-Assist Device as prescribed on a daily basis as discussed with the patient's     doctor   "
66984|NCT02408978|"     Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the     study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The     study will compare the study drug to an already marketed formulation of prescription strength     naproxen (Naprosyn® the reference product) by looking at the relative impact of both products     on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy     (or more specifically, a gastroscopy). The safety and tolerability of the study drug will     also be assessed.   "
66985|NCT02408965|"     Excessive bleeding after dilation and evacuation (D&E) requiring interventions is common,     occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic     prophylaxis at the time of D&E, particularly with methylergonovine maleate (MM), is a common     practice among D&E providers despite nearly no evidence for its efficacy. Finding ways to     decrease excessive bleeding after D&E has the potential both to improve patient safety and to     reduce costs of provider-initiated interventions. The investigators propose a randomized,     controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing     excessive bleeding measured by a composite outcome among women undergoing D&E at 20 to 24     weeks.   "
66986|NCT02408952|"     This study evaluates the implementation and effectiveness of two modalities of Screening,     Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other     drug (AOD) use in a large pediatrics clinic.   "
66987|NCT02408939|"     Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal     insufficiency, and circulatory failure. Such severe pathology may be associated with     increased susceptibility to infectious complications and increased risk of death due to     postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In this     re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will use     individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 &     NCT00729794), in order to determine the effect of stress-dose steroids on the severity of     postresuscitation infectious complications, and more specifically, on the risk of septic     shock-associated death.   "
66989|NCT02408913|"     Background:      - Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to     death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved     treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP (     MVA-EbolaZ g) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune     response against Ebola.      Objectives:      - To see if the two new vaccines are safe and if they cause any side effects. Also, to study     immune responses to the vaccines.      Eligibility:      - Healthy adults ages 18-50.      Design:        -  Participants will get one or two study vaccine injections depending on the study group          they are assigned to. Each injection will repeat the same schedule:        -  A needle and syringe will inject the vaccine into an upper arm muscle.        -  1-2 days later, participants must call the clinic to report how they feel.        -  For 7 days they will check their temperature with a thermometer given to them. They will          look at the injection site, and measure any redness or swelling with a ruler. They will          write down any symptoms they have.        -  In the first 2 months, participants will have at least 6 clinic visits and 1 phone          contact. At each visit, participants will be checked for health changes or problems.          They will tell how they feel and if they have taken any medications. Blood and urine          samples may be collected.        -  Participants might need to have extra clinic visits and laboratory tests if they have          health changes that need to be checked.   "
66990|NCT02408900|"     Background:      - Primary lateral sclerosis (PLS) is a rare disease. It leads to weakness in the muscle of     the arms, legs, and face. People with PLS develop muscle stiffness called spasticity.     Researchers want to find a better way to measure this. They want to see if ultrasound, which     uses sound waves to look at parts of the body, can measure spasticity and stiffness in     muscles.      Objective:      - To see if ultrasound can detect and measure muscle spasticity in people with PLS.      Eligibility:        -  People ages 18 75 who have a diagnosis of PLS and are enrolled in protocol 01-N-0145.        -  Healthy volunteers ages 18 75.      Design:        -  Participants with PLS will have 1 study visit. Healthy participants will have upto 5          visits. Each visit will be about 2 hours.        -  Participants will have tests of muscle strength. They will be examined. They will push          their arms and legs against researchers in different positions.        -  Participants will have tests of muscle stiffness. Their arms and legs will be moved          while they relax.        -  Participants will have a muscle ultrasound test. They will lie on a table. Gel will be          placed on the skin over the muscles of the arms and legs. A probe, like a microphone,          will be moved over the skin. Researchers will look at several muscles.        -  Participants should try to stay still during the ultrasound. It may be done several          times and may be done by different examiners.   "
66991|NCT02408887|"     Background:      - Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard     to detect. People often have lymph nodes removed anyway, and researchers want to study if     this is a good idea.      Objective:      - To compare the effectiveness of removing lymph nodes in the neck that show no evidence of     cancer along with the thyroid, or removing only the thyroid.      Eligibility:      - Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence     that the disease has spread in the body.      Design:        -  Participants will be screened with medical history, physical exam, blood tests, scans,          and x-rays.        -  Participants will:        -  Answer questions. They may have a tumor biopsy.        -  Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal          cords.        -  Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be          removed if the cancer has spread.        -  Group 2: have surgery to remove the thyroid and lymph nodes in the neck.        -  At all post-surgery visits, participants will answer questions and have blood drawn. In          addition:        -  1 day: laryngoscopy.        -  2 weeks: possible laryngoscopy.        -  3 months: ultrasound of the thyroid and neck.        -  Discuss whether to try hormone treatment and/or radioactive iodine.        -  Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a          capsule or liquid and lie under a camera.        -  6 months: ultrasound and maybe laryngoscopy.        -  1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone.        -  Participants will have annual follow-up visits for 10 years. They will have a physical          exam, blood drawn, scans, and may complete a questionnaire.   "
66992|NCT02408874|"     Background:      - Nanosilver is tiny silver particles. Many products contain nanosilver, like antimicrobial     cleaning supplies and antimicrobial fabrics. Some products also contain nanosilver in a     solution that people inhale. The companies that make these products claim they can help boost     the immune system.      Objective:      - To learn if inhaling nanosilver affects the lung s immune system. In addition, to see if     nanosilver affects lung function and if it gets absorbed into the bloodstream after it is     inhaled.      Eligibility:      - Healthy, non-smoking adults ages 18 60.      Design:        -  Participants will be pre-screened by phone.        -  Participants will then be screened with a medical history and physical exam. They will          give blood and urine samples.        -  Participants will have lung function tests. They will breathe into a spirometer. It has          a mouthpiece attached to a tube that is connected to a computer.        -  Participants will have a methacholine challenge test. They will blow into a spirometer.          Then they will inhale methacholine.        -  Eligible participants will have 3 study visits over 2 5 weeks. At each visit, they will          repeat some of the screening tests.        -  At visit 1, participants will have a bronchoscopy. For this, an intravenous line is          placed in an arm vein. Electrodes are placed on the chest. A tube is placed through the          nose and into the airways. The airway is washed. A sample of cells is taken.        -  At visit 2, participants will get the study treatment. They will inhale a nanosilver          solution mist. They will have lung function tests before and after treatment.        -  Participants will collect their urine from the time they get the treatment until they          return to the clinic the next day.        -  At visit 3, participants will turn in their urine. They will have another bronchoscopy.   "
66993|NCT02408861|"     This phase I trial studies the side effects and best dose of nivolumab when given with     ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical     Hodgkin lymphoma that has returned after a period of improvement or does not respond to     treatment, or solid tumors that have spread to other places in the body or cannot be removed     by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth     in different ways by targeting certain cells. Ipilimumab is an antibody that acts against a     molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your     immune system by shutting it down. Nivolumab is a type of antibody that is specific for human     programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune     cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV     associated classical Hodgkin lymphoma or solid tumors.   "
66994|NCT02408848|"     There are few studies evaluating the value of 3D echocardiography in children undergoing     congenital cardiac surgery. The aim of this observational study is to describe common and     uncommon congenital malformations with the help of 3D echo and compare the findings and the     measurements with those obtained with conventional 2D echo.   "
66999|NCT02408783|"     A large number of mothers are uncertain of the date of their last menstrual period and where     there is a high incidence of small-for-dates babies, there is a real need for a method of     estimating gestational age that is both rapid and accurate for early referral and management     of preterm newborns to reduce their mortality and morbidity. The National Family Health     Survey 2005-06 reports that the proportion of low birth weight babies (LBW) in India is 22%.     Of these LBW babies, the proportion of prematurity is not known in the survey as it is     difficult to measure gestational age of the newborn due to lack of reliable and valid scores     with ease of use at the primary health centers. Different scores to assess maturity have been     developed namely New Ballard score, Dubowitz score and Meharban Singh score. It is not known     whether these scores have regional, geographical, racial or ethnic robustness. It has also     been found that these scores tend to overestimate newborns > 37 weeks and underestimate those     >32 and < 37 weeks. The investigators conducted a cross sectional study to validate three     neonatal gestational age (GA) assessment scores namely New Ballard, Dubowitz and Meharban     Singh with the reference standard i.e. GA assessed by LMP using Naegeles rule and validated     by gestational ages also assessed by at least one ultrasound (GA-LMP), in Indian newborns     delivered at a tertiary hospital. The investigators derived a new Simplified Gestational Age     Score (SGAS) using the best applicable items from the three validated scores and assessed     its accuracy with the reference standard (GA-LMP). This score has only 4 items (posture, skin     texture, breast and genital assessment) and community health workers can be trained in     implementing SGAS due to its simplicity. The investigators propose a study in the GN sites to     validate this simplified method of assessment of the GA using our SGAS protocol.   "
67000|NCT02408770|"     The primary objective of this study is to determine the effects of the antiprogestin     ulipristal acetate (UA) on the epithelial and stromal compartments of the normal breast in     women at increased risk of breast cancer (BC) and to relate these effects to quantitative     changes on multiparametric magnetic resonance imaging (MRI). The goal is to define predictive     imaging biomarkers for subsequent testing in randomised prevention trials of antiprogestins.   "
67001|NCT02408757|"     As elaborated above only one study reported ultrasonographic changes of the width of the     lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be     suitable. No firm data exists about the change of the width of the third ventricle, the     diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the     width of these structures has been shown to depend on intracranial pressure. Ultrasonographic     measurements of changes of the width of the third ventricle or the diameter of the optic     nerve would have some advantages compared to the ultrasonographic assessments of the lateral     ventricles. First, the width of the third ventricle can be measured easier and more reliable     than the width of the lateral ventricles (better defined insonation plane and therefore     higher repeatability of measurements) 3. Second, whereas assessments of the width of the side     and third ventricles with ultrasound depend on the temporal bone windows (10 to 15% of     patients have insufficient temporal bone windows), the measurement of the diameter of the     optic nerve does not have this limitation and can therefore be performed in almost all     patients. Hence, measurement of the diameter of the optic nerve would allow to overcome one     major limitation of transcranial ultrasound. The latter limitation for transcranial     ultrasound could also be minimized by the use of an ultrasound contrast agent (SonoVue®), but     this was also not yet studied. The use of an ultrasound contrast agent would in addition     allow to study changes of brain perfusion during clamping of EVD/LD.   "
67002|NCT02408744|"     The aim of this study was to evaluate the impact in safety and efficacy of a new formulation     of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic     kidney Disease (CKD).   "
67003|NCT02408731|"     Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of     oxygen and nutrients that are necessary for cellular function. The current resuscitative     agents can extend patient's life to a limited extent. Centhaquin (PMZ-2010) in very low doses     reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to     be a highly effective resuscitative agent. The investigators are conducting a phase I     clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of centhaquin citrate in normal healthy volunteers.   "
67004|NCT02408718|"     The purpose of this study is to determine whether a training program in the use of ambulatory     assistive devices (such as canes, walkers, etc) can reduce falls and increase functional     mobility and neural connectivity in people with Multiple Sclerosis.   "
67025|NCT02408445|"     This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about     body composition (muscle and fat) and male hormones and look at the effect of testosterone     shots on body composition. We know that older boys and men with Klinefelter syndrome often     have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know     if this difference is present at birth or develops over time. We will learn if body     composition and motor skills are improved with testosterone treatment in infants with     Klinefelter syndrome.   "
67026|NCT02408432|"     The goal of this clinical research study is to learn if adding mesenchymal stem cells (MSCs)     to standard of care drugs can help control heart failure that may have been caused by     anthracyclines (a type of chemotherapy drug used in cancer treatment). The safety of the MSCs     will also be studied.      MSCs are a type of stem cell that can be removed from bone marrow and grown into many     different cell types that can be used to treat cancer and other diseases, such as heart     failure. The MSCs used in this study were collected from healthy donors and are stored and     grown in a laboratory at MD Anderson.   "
67005|NCT02408705|"     Each subject will be allocated to 2 periods of 3 months of once daily dosing with either     liraglutide (1.2 mg) or placebo treatment (in random sequence) as add on to usual intensive     insulin treatment. Wash-out period between treatments will be 1 month.      The trial can be divided into the following periods:        -  Screening        -  Treatment period 1        -  Washout period        -  Treatment period 2        -  Follow up Visit      Mixed Meal Tolerance Test (MMTT) enriched with paracetamol:      At the beginning and end of each period a MMTT (Fortimel complete) enriched with paracetamol     will be performed to assess the remaining beta-cell function via obtained maximal plasma     C-peptide levels as well as the gastric emptying.      Experimental / Hypoglycaemic clamp :      At the end of each period (Visit 8, 15) a hypoglycaemic clamp will be performed. After the     subject completed the MMTT on day 1, the subject will stay in the clinical unit to prepare     for the hypoglycaemic clamp with an variable insulin infusion intravenously in order to     obtain a steady state of a plasma glucose (PG) level of 5.5 mmol/L overnight until     approximately 08:00. At 05:00 hours 10%-[6,6-2H2] glucose solution will be given i.v. as a     primed (9.6mg/kg/min) for one minute and a constant (0.08 mg/kg/min) infusion until the last     blood sampling of the plateau 4.0 mmol/L will be performed.      At 08:00 hours in the morning at day 2, insulin infusion will be increased to 1.5 mU/kg/min     for each subject and the PG will be kept at a plateau of 5.5 mmol/L by a controlled variable     intravenous infusion of glucose (10% glucose enriched with 4mg [6,6-2H2] glucose /ml) for one     hour. Afterwards, PG is allowed to fall to a plateau of 3.5 mmol/L, then to a nadir of 2.5     mmol/L, then to a blood glucose of 4.0 mmol/L and finally back to a level of 5.5 mmol/L for     safety reasons. Blood sampling for measurement of [6,6-2H2] glucose, glucagon, insulin,     counterregulatory hormones, lactate, free fatty acids, glycerol, vital signs, hypoglycaemic     symptoms questionnaire and hypoglycaemic awareness will be performed at each PG plateau.   "
74322|NCT02312934|"     The purpose of this study is to evaluate the use of a nicotine patch as a treatment for     problems with attention, learning and memory in breast cancer patients who are 1-5 years post     chemotherapy.   "
67008|NCT02408666|"     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with     user-friendly active dry electrodes that meets the expectations of the users regarding     comfort and esthetics, without losing sight of the functional and technical demands for     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that     hospital admission in the EMU can be avoided for some patients and an increasing number of     patients can be examined.      In Phase 1 of the project epilepsy patients and their family will be interviewed about their     personal experiences with the condition, EEG registrations, daily life, ... . In addition     EEG-technologists and neurologists will be interviewed about their experience with EEG     registrations and what features their dream EEG-cap would have. The purpose is to gain     insight in the wishes and expectations of the end users so we can take this into account when     designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.      Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50     EEG-technologists or neurologists will be interviewed.      The results of the interviews will be analysed by the design company pilipili nv.   "
67009|NCT02408653|"     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with     user-friendly active dry electrodes that meets the expectations of the users regarding     comfort and esthetics, without losing sight of the functional and technical demands for     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that     hospital admission in the EMU can be avoided for some patients and an increasing number of     patients can be examined.      In Phase 2 of the project will comprise of an EEG-registration with the different types of     electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes     will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and     cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential     (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations,     for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP     measurement with conventionally used wet electrodes (bridge and cup electrodes). Each     EEG-registration will take between 5 and 10 minutes.      Minimum 2 - maximum 10 healthy volunteers will be included.      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical     evaluation of the EEG-signals. User experience will also be collected.   "
67010|NCT02408640|"     The aim of this randomized controlled trial is to investigate the effects of a Swedish     Internet-based treatment program for individuals from the general population with a regular     cannabis use.      The primary hypothesis to be tested is that the use of the Internet-based treatment program     will be associated with more cannabis-free days in comparison to only access to information     about cannabis use and its harmful effects.      The secondary hypotheses to be tested are:        1. That the use of the Internet-based treatment program will be associated with a larger          decline in cannabis consumption (frequency and quantity) among individuals with regular          cannabis use in comparison to only access to information about Cannabis use and its          harmful effects.        2. That the use of the Internet-based treatment program will be associated with a larger          decline in alcohol consumption, depression and anxiety and increased sense of coherence          in comparison to only access to information about Cannabis use and its harmful effects.        3. That the proportion of individuals who seek professional help or talk to their relatives          or friends about reducing or stopping cannabis use will be greater among those who use          the Internet-based treatment program than among those who only have access to          information about cannabis use and its harmful effects.      Recruitment procedure and baseline measures Study participants will be recruited through an     advertisement on Cannabishjalpen.se. Interested individuals will answer questions about     gender, age, country of birth, educational attainment, employment, marital status, living     situation, and cannabis use.      The intervention group Individuals randomized to the intervention group will directly after     randomization answer questions about alcohol use, use of drugs other than alcohol and     cannabis, depression, anxiety, a sense of context and whether they during the last 12 months     has received professional help to reduce or quit their cannabis use or during the same period     have raised this issue with their relatives or friends.      Further, they will fill out a survey on Internet-based services for individuals who wish to     reduce or quit their cannabis use. The study participants will then be informed that they,     within two days, will gain access to an internet based treatment program designed to help     them quit their cannabis use and that they through the program will have the opportunity to     communicate with a therapist. Within the next two days, they will gain access to the     internet-based treatment program, they will have access to it for two months and they will be     contacted again after three months to answer questions about their cannabis and alcohol use,     as well as about other previously mentioned issues.      The control group Individuals randomized to the control group will undergo exactly the same     procedure as the intervention group. The difference is that the control group will be     informed that they in about three months will gain access to an internet based treatment     program designed to help them quit their cannabis use (i.e. when the data collection for     follow-up is completed).      Otherwise, participants in both groups will have the opportunity to use factual information     that is available to everyone on Cannabishjalpen.se.      Follow-up procedure Study participants who were randomized to the intervention group will     have access to intervention in two months. Three months after recruitment to the study, study     participants from both groups will get an automated email invitation to participate in the     three-month follow-up. The email will include a personalized link that when clicked on will     redirect the participant to follow-up page where they will be asked to once again answer     questions about their cannabis and alcohol use, depression and anxiety, seeking professional     help for cannabis use as well as the help of family or friends and questions about whether     they have used any other internet or telephone services to reduce or quit their cannabis use.     The entire follow-up procedure will be completed via the internet.   "
67048|NCT02408133|"     The purpose of this study is to evaluate the effectiveness of home exercise on quality of     life and physical fitness of elderly women with breast cancer patients undergoing cancer     treatment.   "
67287|NCT02404987|"     Post-marketing observational study of a nutritional care plan, including a higher calorie,     higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free     living and residing and nursing homes, who have been identified as malnourished. The     objective is to assess the impact of the ONS on body weight, activities of daily living and     quality of life.   "
67011|NCT02408627|"     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with     user-friendly active dry electrodes that meets the expectations of the users regarding     comfort and esthetics, without losing sight of the functional and technical demands for     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that     hospital admission in the EMU can be avoided for some patients and an increasing number of     patients can be examined.      Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.      Phase 3a of the project will comprise of an EEG-registration with the different types of     electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on     EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the     EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each     EEG-recording will take approximately 10 minutes.      Minimum 2 - maximum 10 epilepsy patients will be included.      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical     evaluation of the EEG-signals. User experience will also be collected.   "
67012|NCT02408614|"     The study objectives are the following: 1) To examine the acute vascular responses to     continuous low- and moderate-intensity exercise and interval training; and 2) To examine the     influence of age and gender on these responses.   "
67058|NCT02408003|"     The investigators want to compare the effects of two drugs, levosimendan and milrinone, on     cardiac muscle, both in terms of contractility and relaxation. Half of the participants will     be randomized to each drug. The effects will be measured through echocardiographic     deformation analyses.      Since deformation analyses could be dependent on different loading conditions of the heart, a     second purpose of the study is to investigate the changes on deformation parameters after     applied changes in preload and afterload, but also heart rate.   "
67013|NCT02408601|"     Background and study aims:      The investigators are carrying out a clinical trial of two different sealant materials to     compare the retentivity and decay inhibiting properties of the above said materials. it is a     split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite     placed molars of 180 healthy school children in the age group between 7 - 10 yrs of age.      who can participate? school children in the age group between 7 - 10 yrs of age with non     decayed contra lateral permanent 1st molars at a school in the southern part of India.      what does the study involve? over a period of 18 months, the retentivity and the decay     preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS)     will be clinically assessed by us.      possible benefits/ risks of participating in the trial the participants will be not be     exposed to any kind of risks as it is a non invasive procedure the possible benefits may be     preventing decay to the permanent molar in the long run      study start date/duration of the study? MARCH 2015 is the month wherein the sealant     applications have started and expected to last till the Sept of 2016      funding? self funded study   "
67014|NCT02408588|"     Using a pulse oximeter, the investigators have developed an algorithm that assesses central     volume status. Pregnant women present some unique opportunities for us to investigate the     algorithm under different circumstances. The investigators want to specifically investigate     an algorithm with women who undergo regional anesthesia such as epidurals, with women who     undergo fetal surgery, and with women in labor and giving birth (and the recovery time     following delivery). This will help the investigators understand the central volume status     changes that women experience in these unique circumstances. The Investigators also want to     put the pulse oximeter on the fetal hand when possible during certain maternal fetal     interventions. The Investigators would like to examine the algorithm with data from the     fetuses.   "
67015|NCT02408575|"     Pilot study on safety, tolerability and clinical performance/randomized double-blind     active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus     Center of Regensburg and groupwise randomized. Control groups are being treated with hearing     aids without notch-filter. Patients and raters are blinded, only the coworker, who is     programming the hearing aids, is informed about the group assigned.      A Hearing aid with notched amplification filters frequencies in a specific manner, depending     on the individual tinnitus frequency. Through this special filtering the neuronal functional     changes of the auditory cortex are supposed to be affected therapeutically.   "
67016|NCT02408562|"     This is a phase I, randomised, placebo-controlled study to assess the safety and tolerability     of two 2-weeks cycles of i.c.v. administration of sNN0031 infusion solution to patients with     PD of moderate severity with persisting on-off symptoms in spite of other PD medications.   "
67018|NCT02408536|"     The purpose of this study is to retrospectively evaluate treatments and outcomes of patients     with low grade serous ovarian carcinomas in Italy.   "
67021|NCT02408497|"     A single arm phase II study of prostate motion for prostate cancer to primarily compare     prostate motion between different treatment duration for IMRT and VMAT.   "
67022|NCT02408484|"     This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the     on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients less     than 12 years of age.The planned study duration is up to 5 years. The study will be     considered completed when a minimum of 6 subjects (i.e., at least 3 subjects aged between 0     and <6 years and 3 subjects aged between 6 and <12 years) have at least one documented     bleeding episode and when in total a minimum of 2 surgical procedures have been performed.      All patients will undergo a pharmacokinetic (PK) study after screening. This will have a     duration of 14 days, after which a patient can be treated for a bleeding episode or planned     surgical procedure when they occur.   "
67023|NCT02408471|"     This study is a non-randomized, consecutive enrollment, one-year post-approval study of     patients who are treated with the Ascension® MCP.   "
67024|NCT02408458|"     This study is being conducted to gather long-term data of the performance of the Miromatrix     Biological Mesh.   "
67078|NCT02407743|"     The purpose of this research study is to determine what causes pain after surgery to increase     or decrease over time.   "
67027|NCT02408419|"     About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a     femoral nerve block. One of the possible causes of this failure to provide analgesia from a     single nerve block could be the that other nerves occasionally are involved in transmitting     the pain signal. One of the nerves that is believed to give off branches to the hip is the     obturator nerve.      With ultrasound it is possible to make a selective proximal nerve block of the obturator     nerve.      The aim of this trail is to give patients with hip fracture and only insufficient effect of a     femoral nerve block a supplementary obturator nerve block in a randomized manner with either     local anesthetics or placebo in order to access the preoperative analgesic effect.   "
67028|NCT02408406|"     This partially randomized pilot clinical trial develops and studies a software program,     called PatientCareAnywhere, to see whether it can help patients communicate with their     doctors and other healthcare providers, and educate themselves about their cancer and     treatment options. A program that can help patients learn about their cancer and treatment     options, and allows the patient's healthcare providers to receive their questionnaire     results, may help patients identify and get help to treat their symptoms.   "
67029|NCT02408393|"     Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence     of chronic pain 3 months after breast cancer surgery.   "
67030|NCT02408380|"     This study investigates whether there is a link between disease activity/progression in     patients receiving Gilenya and expression of a putative biomarker signature in patients with     multiple sclerosis.   "
67057|NCT02408016|"     This phase I/II trial studies the side effects and best dose of genetically modified T cells     in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma.     Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have     a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell     from patients, called T cells, and modifies their genes in the laboratory so that they are     programmed to find cells with WT1 and kill them. The T cells are then given back to the     patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack     cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may     help the body build an immune response to kill tumor cells.   "
67031|NCT02408367|"     Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to     the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis     (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve     cardiovascular and cognitive functions in pwMS have become important aspects of standardized     rehabilitation programs. Recent findings show that the achieved adaptations through exercise     are associated with the intensity dependent lactate increases during exercise. This     dose-response relationship between the mode and the exercise intensity implicates the     relevance of the exercise protocol as higher exercise intensities seem to facilitate greater     benefits, also in pwMS.      This pilot study evaluates the influences of acute bout of moderate physical exercise     (cycling) and relaxation on cognitive functions at three time points.      Primary outcomes are the differences (at timepoint t2) of cognitive functions assessed via     the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised     (BVMT-R) T1-3 of the BICAMS battery.      Results should into a randomised controlled Trial that investigates the specific influences     of a three-week training intervention on Brain-derived neurotrophic factors (BDNF), Insulin     Growth Factor-1 (IGF-1) and Vascular Endothelial Growth Factor (VEGF) as central     neurobiological parameters of neuroplasticity, cardiorespiratory Fitness and cognitive     functions.   "
67032|NCT02408354|"     The purpose of this project is to study the efficacy of triheptanoin oil in patients with     Alternating Hemiplegia of Childhood (AHC) due to ATP1A3 gene mutation.   "
67033|NCT02408341|"     Background: Propofol effects dose-dependent myocardial depression, but there is little     clinical data available regarding the direct impact of propofol induction on myocardial     function.      Objectives: The purpose of this study was to examine the impact of propofol-based anesthesia     induction on cardiac function in low-risk patients.   "
67034|NCT02408328|"     Apnea is a common discharge-delaying diagnosis in the Newborn Intensive Care Unit. While it     is relatively more common in extremely premature infants, it also occurs frequently in late     preterm and even full term infants. Since the majority of all births include late preterm     infants and full term infants, the absolute number of late preterm and full term infants with     apnea remains significant. Evidence-based guidelines for the management of apnea in such     infants do not exist. Current management falls into two distinct but very different     categories. This study will compare these two distinct management strategies.      Our study will be a prospective, randomized pilot trial to provide data regarding (a)     feasibility for recruitment and study protocols and (b) provide preliminary data regarding     efficacy of both treatment arms.      Our primary objective will be to test the hypothesis that early discharge and outpatient     monitoring of late preterm and term infants with apnea of prematurity results in decreased     length of hospital stay, is safe, and results in improved patient satisfaction, as assessed     by the PedsQL questionnaire and Impact on Family Scale.      Our study population will include infants who meet the following criteria: (1) Born at     greater than or equal to 34 0/7 weeks gestation; (2) Are assigned a diagnosis of apnea,     bradycardia, and/or oxygen desaturations by the primary clinical team; (3) Have met all other     discharge criteria (i.e. feeding maturity, temperature regulation, etc.) so that     apnea/bradycardia/desaturation remains the final discharge issue for at least 7 days.      Infants enrolled in this research study will be randomized to in hospital observation versus     early discharge home with caffeine and a home monitor. Neither strategy is experimental as     both are currently utilized by neonatologists locally and nationally. A direct comparison of     the two treatments, however, has never been undertaken in a study. If an infant is assigned     to the in hospital group, they will remain in the hospital until an apnea free period of at     least 5 consecutive days has been established. Outpatient follow up will occur per unit     standard and typically includes a nursing visit and a doctor visit within 2-3 days of     discharge. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1     month after hospital discharge, and at 6 months of age. Each questionnaire will ask about     topics such as satisfaction with hospital stay, quality of life, and numbers of acute care     visits and/or rehospitalizations. Alternatively, if an infant is assigned to the early     discharge group, caffeine will be given to the infant and if after a 3 day period no further     apnea is noted the infant will be discharged home with continued daily caffeine therapy by     mouth as well as a home monitor. Caffeine is a very commonly used drug in neonates and has an     excellent safety profile. Side effects are minimal and may infrequently consist of     gastroesophageal reflux. All caregivers will receive training on the use of a home monitor.     Initial outpatient follow up will occur per unit standard and typically includes a nursing     visit and a doctor visit within 2-3 days of discharge. Additionally, caregivers will be     contacted via telephone within 2 days to answer any questions or address any concerns     pertaining to apneic events, home monitor use, or caffeine therapy. Follow up in the     pulmonary clinic will be arranged at 42-43 weeks gestational age at which time caregivers     will be taught to determine the baseline frequency of monitor alarms on caffeine. At 43 weeks     corrected gestational age, caregivers will be instructed to discontinue caffeine therapy and     advised to contact the pulmonary clinic should alarm frequency increase. An outpatient     recorded oximetry study will be arranged at least 1 week after discontinuation of caffeine     therapy. Home pulse oximetry monitoring will be discontinued if no significant events are     recorded. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1     month after discontinuation of the home monitor, and at 6 months of age. Each questionnaire     will ask about topics such as satisfaction with hospital stay, quality of life, and numbers     monitor alarms, acute care visits and/or rehospitalizations.   "
67035|NCT02408315|"     The primary objective of this study is to compare the efficacy and safety of vaginal and     buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0     completed weeks gestation. Thus, the investigators have both efficacy and a safety primary     outcomes.      The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with     these two routes of administration in a sub-cohort of this trial. The long term objective of     this line of research is to inform providers' clinical decision making for the large number     of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation,     clinical outcomes data for these two routes of administration, clinicians will be informed     for evidence-based decisions about the preferred route of administration of misoprostol.   "
67036|NCT02408302|"     Currently Midazolam sedation is the standard of care for minor invasive procedures in     pediatric patients; its use is restricted to two routes of administration for this purpose     oral and intranasal.      A third route of administration (buccal) is tested and approved for seizure management. In     the investigators' study the researchers investigate the buccal route of administration     versus oral or intranasal administration for sedation. The investigators' hypothesis is that     buccal route of administration is more convenient than intranasal and better absorbed than     oral.   "
67037|NCT02408289|"     The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite     in humans. In addition the study is designed to test epicatechin, a compound found in cocoa     and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite     in humans.   "
67038|NCT02408276|"     Femoroacetabular impingement (FAI) is one of the most common mechanisms leading to the     development of early cartilage and labral damage in the non-dysplastic hip. Anatomic     abnormalities of the proximal femur and/or acetabulum result in repetitive injury during     dynamic hip motion, leading to abnormal regional loading of the femoral head-neck junction     against the acetabular rim. The resulting damage to the cartilage, labrum, and surrounding     capsular structures predispose the patient to developing hip pain and early osteoarthritic     changes. Clinically, patients with FAI are a heterogeneous group, with a wide array of     presentation from pain to instability that may or may not be related to activity. To date no     studies have identified specific prognostic indicators associated with successful surgical     treatment of FAI, leaving surgeons without adequate criteria to determine which patients are     best suited for arthroscopy. The investigators propose to address this critical knowledge gap     by identifying the patient characteristics and morphological features of the hip that are     associated with the optimal clinical outcomes in patients undergoing hip arthroscopy or     non-operative management for treatment of suspected FAI in order to establish a treatment     algorithm for FAI patients.   "
67414|NCT02403336|"     Objective: To evaluate the efficiency of a group intervention opposite to the usual care to     improve the quality of life, measured with the SF-12 questionnaire, in women between 45-55     years to the primary health care centres.   "
67039|NCT02408263|"     Pain has been defined as a subjective experience. Various pain assessment tools, (such as     NRS) have been developed and validated to objectively monitor and treat pain. There are     certain patient populations, in whom, the current pain assessment tools cannot be used     effectively due to communication problems such as cognitively impaired patients. In the US,     the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it     mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that     would objectively measure pain, there is also risk of under treatment and overtreatment of     pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain     levels objectively, will help to achieve above goals. The investigators are using Skin     Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.   "
67040|NCT02408250|"     Practice guidelines recommend early physical therapy in intensive care unit. Feasibility,     safety and efficacy are confirmed by growing evidence based data. However, the scientific     literature emphasizes the heterogeneity of targeted populations, lack of precisions     concerning eligibility criteria, program modalities, timing initiation, progressions and     stopping criteria. However, all these results remain to be precised and confirmed. So, the     investigators hypothesize that an early exercise program in intensive care unit formalized     from a decisional algorithm is well tolerated in clinical practice.   "
67059|NCT02407990|"     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment     effect of a new drug known as BGB-A317 in patients with advanced tumors.   "
67041|NCT02408237|"     Neuromodulation is characterized as a technique whose principle neurostimulation to produce     inhibition or cortical arousal. The tDCS (transcranial direct current stimulation) is a     noninvasive brain stimulation method used to modulate cortical excitability using low     intensity direct current (1-2mA) directed to the scalp via cathodes and anodes electrodes;     the current reaches the cortex, producing hyperpolarization or depolarization of the axonal     membrane potential. Evidence has shown that this method is presented as a technique that can     alter cortical and subcortical neural networks. This technique has been used to treat     psychiatric disorders such as depression, acute mania, bipolar affective disorder panic,     hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation     after-stroke and pain syndromes such as neuropathic pain, migraine, pancreatitis chronic pain     and fibromyalgia. It is low-cost technique, with virtually no side effects and carries the     therapeutic effect by neuromodulatory pathways by distinct pathways activated by the drugs.     In this scenario falls within the importance of developing devices for home use, inexpensive,     and easy to use so as to maintain the benefits observed in previous studies. The tDCS is     presented as a non-pharmacological option that may be offered in this context in society. It     is noteworthy that, if the benefit is demonstrated, the impact will be of great importance to     patients and to society, since these are focal techniques and low cost. Because they have no     focal adverse effects of conventional drug treatments. Additionally, can be constituted as     technical additive to pharmacotherapy in so much pain as in the treatment of other     neuropsychiatric disorders. Therefore, further studies should be encouraged to increase     knowledge of their effects and mechanisms involved. If the effectiveness of this method for     home use is confirmed, the therapeutic impact will undoubtedly be of great importance.     However, to make this project come true, the investigators depend on support for the     development and validation of tDCS device for home use, so allowing the qualified knowledge     can be applied to the clinical setting, as well as advance the development of this area of     neuroscience in Brazil. Therefore, the aim of this study is to develop tDCS device for home     use.   "
67042|NCT02408224|"     The TREASURE observational study is designed to address the need to understand the usage     pattern of Ticagrelor in real life scenario in large number of ACS (Acute Coronary Syndrome)     patients in India. The aim of this national study is to understand the usage pattern     (including the duration of treatment) of Ticagrelor in various ACS patient population     undergoing PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Graft) or     medical management in a real-life setting in India.   "
67043|NCT02408198|"     This study aims to evaluate a novel group psychological intervention targeting anxiety     triggered by urban environments for people with paranoia.   "
67044|NCT02408185|"     Phase II clinical trial, open-labelled, prospective and single-center study directed to     obtain blood samples in experimental detailed conditions in order to compare and optimize the     dose of colistin in critically ill patients suffering from infections on which the indication     of colistin would be accepted according to normal local protocols for severe infections     treatment.   "
67045|NCT02408172|"     Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to     7% in middle aged individuals and increases with age. OSA has been identified as the most     common secondary cause associated with resistant hypertension. There is evidence that     compared with older patients, the risk of hypertension in OSA patients may be particularly     pronounced in younger adult ones (less than 50 years).      Traditionally, cardiovascular risk stratification in hypertensive patients was based on the     average blood pressure (BP) measured in the clinic. Accumulated data has shown that     target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP     variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that     BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes,     independent of average BP. In addition, it has been found that hypoxia condition in     pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP.     However, the selections of antihypertensive drugs remain yet not very clearly for     hypertensive patients combined with OSA.   "
67046|NCT02408159|"     This study will evaluate the ability of the vaccine to produce antibodies against herpes     zoster virus (shingles) and safety of vaccination with Varicella Zoster Vaccine in patients     with moderate to severe psoriasis who will initiate biologic therapy 4 to 6 weeks after     vaccination.      Varicella Zoster Vaccine will be administered 4 to 6 weeks prior to receipt of biological     therapy and will be compared against placebo.      This double-blind study will enroll approximately 50 adult patients with moderate-to-severe     plaque psoriasis in approximately 3 centers in Canada. Study products will be assigned     randomly at a 4:1 ratio.      For each patient who is included, the study may last up to 22 weeks, including the screening     and the follow-up period. During the study, subjects will come to the dermatology clinic up     to 4 occasions: for a screening visit, Baseline visit, Day 42 as well as 84 days after they     started taking the biological treatment for a last visit. If patients develop a     varicella-like or shingles-like rash at any time after they received the vaccine, they will     be requested to come back to the clinic within 72 hours of rash onset (preferably within 24     hours) for examination. Subjects will be asked to provide a lesion swab/vesicular fluid in     this case.   "
67047|NCT02408146|"     The investigators hypothesized that using new intravenous infusion pump of patient-controlled     analgesia (parecoxib sodium 1 mg/mL + normal saline) would significantly improve     postoperative pain control compare to conventional intravenous infusion pump of     patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16     mg/8 mL + normal saline). This prospective randomized controlled trial was designed to     evaluate the benefit of new intravenous infusion pump of patient-controlled analgesia     (parecoxib sodium 1 mg/mL + normal saline) for postoperative analgesia after laparotomic     liver resection.   "
67049|NCT02408120|"     The purpose of this study is to test whether using extra doses of aspart insulin to correct     blood sugars before meals improves the care of patients with type 2 diabetes in the hospital     who are already receiving the standard of care treatment with glargine and aspart insulin     injections to control blood sugar levels. Studies done in the past indicate that blood sugar     levels are controlled on the standard treatment of insulin and that most patients do not need     the small extra dose of insulin at bedtime. The investigators want to test if there is any     benefit to giving patients extra doses of insulin during the day to correct the high blood     sugars.   "
67050|NCT02408107|"     The aim of this current study was to investigate the effects of a pragmatic home-based     physical activity programme on primarily physical activity levels and secondarily weight     maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid     concentrations in post-adjuvant therapy breast cancer survivors.   "
67051|NCT02408094|"     The purpose of this study is to explore the protein markers and to applicate those protein     markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA.   "
67052|NCT02408081|"     The purpose of this study is to determine whether Family Focused Nursing are effective in the     treatment of elderly medical patients with respect to prevalence of depression   "
67060|NCT02407977|"     This is an observational study. This protocol will determine the feasibility of using a novel     nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than 1 mm     wide, to measure real-time, pin-point, in-vivo radiation dose given during external beam     delivery of radiation therapy treatments.This new protocol is similiar in design to     Pro00050297 with the significant difference being the monitoring will be performed during     external baem radiotherapy.   "
67061|NCT02407964|"     This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic     study without any clinical treatment. Its primary objective is to understand 1) incidence of     drug-induced liver injury, including incidences among all the hospitalized patient, among     patients in department of hepatic diseases, digestive diseases, oncology, hematology etc.,     individually; 2) epidemiologic characteristics of drug-induced liver injury, including     suspected medications, clinical types, histological characteristics, severity and outcomes.   "
67062|NCT02407951|"     Tourette Syndrome (TS) is a disorder characterized by motor and vocal tics. The most studied     and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral     Comprehensive Intervention for Tics (CBIT). Group intervention for children with TS has not     been evaluated. The aim of this study is to assess the efficacy of CBIT group intervention     compared with Psycho-Educational-Supportive group in terms of tic severity.   "
67063|NCT02407938|"     Normal values for measurements of high resolution manometry in a protocol which includes     isolated liquid swallows in upright and recumbent position, free drinking of water, a solid     test meal and a postprandial observational period will be determined.   "
67064|NCT02407925|"     In this study, Dutch gastroenterologists who are certified for performing colonoscopies on     FIT-positive patients in the Dutch population screening program are trained in optical     diagnosis with validated methods. After this training, an ex- and in-vivo test phase leads to     accreditation and endoscopists will be observed in their optical diagnosis for 1 year.     During this year, half of the endoscopists will be randomized towards 3-monthly feedback and     the other half will receive feedback on their results after 1 year. The endoscopic prediction     of endoscopists on polyp histology will be compared to histopathological outcome.   "
67065|NCT02407912|"     To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for     malignant pleural effusion in patients with non-small-cell lung cancer.   "
67066|NCT02407899|"     The main purpose of this study is to evaluate whether saxagliptin (and vitamin D3) with     insulin therapy can better protect islet β cell function than insulin alone.   "
67067|NCT02407886|"     Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in     nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans,     retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to     occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in     adults is considerable rare. It is, however, well established that retrograde transsynaptic     degeneration affects other neural systems in humans even when the injury occurs during     adulthood. Some histopathological evidence points to the possibility of transsynaptic     degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults,     but the clinical significance is unknown.'      Purpose:      To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to     intracerebral processes. To correlate GCL with the localization and type of intracerebral     lesion.      To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2     parameters is more sensitive to show retinal layer abnormalities.      To correlate GCL with visual field defects and electrophysiological parameters.   "
67068|NCT02407873|"     The score on the Edmonton frail scale will be recorded in 250 consecutive patient aged of 75     years or more and undergoing elective cardiac surgery. In those patients the investigators     will also record the ITU length of stay, the hospital length of stay, the incidence of     complications, the ability to be discharged home and to live independently at postoperative     day 30.      The ability of the Edmonton score to predict complication, prolonged hospital and ITU length     of stay as well as loss of autonomy at discharge and day 30 will be assessed.   "
67069|NCT02407860|"     Breastfeeding is the physiological and recommended way of feeding newborns as indicated by     the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in     Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to     Statistics Canada, the first month of life is the most at risk time to wean because of     technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite     a supportive network of health care professionals including lactation consultant, many babies     are weaned. Lactation consultant are often feeling helpless when facing these mechanical     difficulties.      The purpose of this study is to determine the efficiency of an osteopathic treatment for     newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is     that an osteopathic treatment integrating in the usual care is more efficient than usual car     alone to help healing mechanical breastfeeding issues.      The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each     group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The     control group will receive usual care with a lactation consultant and the intervention group     will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial:     the osteopath finds out, prior to evaluating the patient, what intervention should be     delivered to the baby (assessment alone or standardized osteopathic treatment for infant).      The results will ultimately lead to improvements in the existing knowledge on the fields of     osteopathy and lactation support, allowing implementation of osteopathic care in the     perinatal network.   "
67070|NCT02407847|"     The aim of this study is to explore the effects of substitution in out-of-hours primary care.     In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse     Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms of     feasibility and cost-efficiency.   "
67169|NCT02406560|"     Each subject will be given tafamidis after either a high fat meal or while fasted. After     swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one     week. After about 14 days, subjects will take either a different dose of tafamidis or the     same dose under the opposite meal condition. Tafamidis concentrations from the three     different conditions will be compared to determine if they are approximately the same.   "
67071|NCT02407834|"     This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in different     concentrations for denture cleanliness, regarding biofilm removal capacity, remission of     atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against     specific microorganism. Sixty-four denture wearers with absence (n=40) or presence of     Candidiasis (n=24) were selected and oriented to brush their dentures with a specific brush     and neutral soap for 3 minutes, 3 times a day and immerse them, once a day, in hygiene     solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3; Saline - S4:     control) during 20 minutes, for 7 days. The solutions were used in a randomized, double blind     and cross form with washout periods. To quantify biofilm with software ImageTool 3.0, the     inner surface was disclosed (1% neutral red) and photographed at the end of each period. The     Candidiasis remission was assessed by scores before and after the use of solutions. Patient     satisfaction was assessed by questionnaire. Antimicrobial activity was determined by Colony     Forming Units (CFU) counts of Streptococcus mutans, Candida spp., and gram-negative     microorganisms. For collecting biofilm, internal surface of each maxillary complete denture     was brushed with saline solution, and the biofilm suspension obtained. After serial dilutions     (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar     base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or     gram-negative microorganisms, respectively. After incubation, colonies were counted, and     values in CFU/mL were calculated. Biofilm removal was analyzed as a split-plot with two     variation factors: inflammation and solutions. The candidiasis remission was analyzed after     adjustment using multinomial logistic regression. Logistic regression analysis and compound     symmetry was adopted for patient satisfaction. The antimicrobial action was analyzed with     Friedman´s test. Antimicrobial action data were processed after transformation - log10 (CFU +     1) - and were analyzed by Friedman test (α = 0.05).   "
67072|NCT02407821|"     In this study the investigators hypothesize that antidepressant therapy may improve the     overall welling of patients with acute or chronic kidney disease when given around the time     of starting chronic dialysis therapy. This study is a pilot, randomized controlled trial that     aims to examine whether prescribing oral escitalopram to all incident dialysis patients is     safe and feasible.   "
67073|NCT02407808|"     The overarching goal of this study is to characterize the effects of cannabinoids on working     and episodic memory.   "
67074|NCT02407795|"     A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with     stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal     metastases.   "
67075|NCT02407782|"     Scabies remains a frequent condition that affects adults and children. The aim of this study     is to compare the efficacy and safety of two drug treatments against scabies in children and     their close contacts. One group will apply topical permethrin 5% and the other group will     receive oral ivermectin.      Both groups will be treated twice, once at inclusion and the second time 10 days later. Both     treatment regimens have been used widely and are safe to use.   "
67076|NCT02407769|"     Assess the impact in body composition and handgrip strength of the nocturne supplementation     by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)   "
67077|NCT02407756|"     The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of     dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for     adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).      The secondary objective of the study is to explore the immunogenicity and efficacy of     dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years     of age) or severe AD (for children ≥6 to <12 years of age).   "
67079|NCT02407730|"     Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage     and pregnancy complications. Thrombophilia could favor the development of thrombosis of the     maternal vasculature and obstacle placentation. Some studies have suggested a role of     thrombophilia in the failure of assisted reproductive techniques although this association     has been recently questioned. The scope of this study is to evaluate the effect of     thrombophilia on the implantation rate and live birth rate in women undergoing ART.      Design: prospective, observational study Primary end-point: live birth rate. Secondary     end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks     post-partum   "
67080|NCT02407717|"     Patients with cancer hospitalized for an acute medical illness have an increased risk of     venous thromboembolic events. Although international guidelines suggest the use of     thromboprophylaxis in these patients, the recommendations are based on studies which included     a percentage of patients with cancer without primarily focusing on this high risk group.      Since patients with cancer present an increased risk of bleeding complications it is critical     to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a     limited use of thromboprophylaxis in these patients.      The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in     medical cancer patients hospitalized for an acute medical disease.      Design: observational, prospective study Primary end-point: incidence of major and clinically     relevant non major bleeding during hospitalization Secondary endpoints: frequency of use,     doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic     events up to three months after discharge   "
67081|NCT02407704|"     This pilot study aims to test a model that predicts that enhanced neurotransmitter     gamma-aminobutyric acid (GABA) function in reward and affect-regulation central nervous     system (CNS) circuits mediates the antidepressant effects of exercise. State-of-the-art     magnetic resonance (MR) imaging, cognitive assessment, accelerometry, genetic, and     inflammatory biomarkers will be acquired through the coordination of efforts from several     established research programs at Western Psychiatric Institute and Clinic. This pilot study     will be used as a platform for testing a causal/mediating role of GABA interneurons in reward     processing and affect regulation in humans. This pilot study is not powered for testing a     full causal model, but rather is intended to test overall feasibility of the intervention and     acquisition of measures (see specific aim 1 below). This is a necessary prerequisite for     designing a larger more definitive study of the model, which will be a component of a future     grant application. Additionally, the data from this study will be used to test the clinical     efficacy of exercise as an adjunctive treatment for late life depression (LLD; Specific Aim     2), as well as imaging, cognitive, and sleep aims (Specific Aims 3 and 4).   "
67094|NCT02407535|"     In this study the investigators aim to assess the diagnostic performance of intraoperative,     ultrasonographic assessment of the surgical extracted uterus for determining myometrial     invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection     and final pathological report (gold standard). The investigators hope that intraoperative     gross inspection of the extracted uterus might offer an additional intraoperative tool for     assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least     as good as pathological exam.   "
67082|NCT02407691|"     With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned     from a terminal illness to a long-term condition. It is likely to be accompanied by higher     levels of disability and other chronic non-communicable diseases, resulting from the HIV     itself, as well as adverse effects of medication. This requires an expansion of the purview     of HIV care beyond direct HIV clinical care to also include a more comprehensive and     integrated package of treatment and care for physical and mental conditions and their     consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public     sector primary care clinics in the North West Province of SA. It will assess mental health     and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness     of a facility-based stepped care intervention combining depression case detection by     non-physician clinicians with group counselling intervention delivered by lay-health workers.   "
67083|NCT02407678|"     The assessment of the efficacy (with respect to preservation of visual function and retinal     structure) and safety of a single subretinal injection of AAV2.REP1 in participants with a     confirmed diagnosis of choroideremia, as evaluated by various functional and anatomical     outcomes measured over a number of time points up to 24 months post-treatment.   "
67084|NCT02407665|"     This exploratory study proposal is the first pilot brain imaging study to determine if Tai     Chi can modulate brain resting state functional connectivity (rsFC) and brain morphometry     among fibromyalgia (FM) patients and healthy controls.   "
67085|NCT02407652|"     The purpose of this study is to explore the effectiveness of an internet-delivered cognitive     control training as a preventive intervention for remitted depressed patients.   "
67086|NCT02407639|"     Studies in adults have shown that post-procedural abdominal pain is reduced with the use of     CO2 instead of air for insufflation during colonoscopy. The aim of our study is to compare     post-procedural abdominal pain and girth in children undergoing colonoscopy using CO2 or air     for insufflation.   "
67087|NCT02407626|"     This study evaluates the myocardial protection against perioperative ischemia comparing two     standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of     the patients will receive volatile anesthesia while the other half will receive total     intravenous anesthesia. Primary and secondary outcome parameters will be assessed after     induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.   "
67088|NCT02407613|"     This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with     early-stage breast cancer with a maximum diameter of 3 cm undergo MR-HIFU ablation, followed     by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is     to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective     is safety assessment.   "
67089|NCT02407600|"     This study evaluates the addition of fosaprepitant to currently available antiemtic     treatments of carboplatin chemotherapy-induced nausea and vomiting in advanced non-small cell     lung cancer patients. Half of the patients will receive fosaprepitant in their first     chemotherapy cycle, and a placebo on their second chemotherapy cycle. The other half of the     patients will begin their first chemotherapy cycle.   "
67100|NCT02407457|"     The objective of this post-market study is to evaluate Endologix AFX endovascular AAA system     with anatomical fixation against other approved Endovascular systems with proximal fixation.     Multiple U.S clinical centers will be involved in the study to include a broad range of     experience. Imaging data will be evaluated by an independent core lab.   "
67101|NCT02407444|"     This study aims to evaluate whether a combination of cycling training as part of     physiotherapy treatment will contribute more than conventional physiotherapy treatment for     elderly patients after hip fracture surgery in their subacute phase of rehabilitation.   "
67090|NCT02407587|"     Investigators hope to study patients with 1 cochlear implant and who have had hearing     preservation surgery and compare the changes in the brain of these patients with normal     hearing patients by doing a scan of the brain when listening to speech. The information     investigators collect may help investigators to understand how the brain learns to hear with     a cochlear implant and whether it uses the same areas in the brain to listen as in normal     hearing patients as well as predict which patients will do well with a cochlear implant as a     very specialised operation is needed to insert the cochlear implant in to the ear and is done     by very few surgeons in the country. After the operation, patients need several months of     teaching to help them learn how to hear through the implant. Having a cochlear implant     requires a lot of cooperation and time from the patient and if investigators could understand     how the brain learns to hear with a cochlear implant and predict which patients do well and     why then we may be able to avoid unnecessary procedures.   "
67091|NCT02407574|"     The aim of the study is to determine whether increasing the heart rate by epicardial atrial     pacing after surgery improves the contractile force of the myocardium. After complete weaning     from CPB, several pressure-loops of the LV will be recorded at different levels of preload     using transoesophageal echo, invasive blood pressure monitoring. The preload will be     manipulated by adding fluid from the CPB reservoir or draining fluid into the CPB reservoir.   "
67092|NCT02407561|"     Patients with locally advanced rectal and esophageal carcinomas typically undergo neoadjuvant     chemoradiation therapy prior to surgical resection. While response rates to this treatment     differ among these three cancers, generally 20-25% of patients exhibit minimal or no response     to preoperative chemoradiation therapy while 20-30% exhibit a complete pathologic response,     and the remainder receiving a partial response.      This will be a multi-center study of patients with newly diagnosed rectal adenocarcinoma, or     anal squamous cell carcinoma (SCC) who will undergo neoadjuvant chemoradiation prior to     surgery. The tumor from these patients will be tested to determine whether response to     neoadjuvant chemoradiation can be accurately predicted.   "
67093|NCT02407548|"     In previous study the investigators found that CoQ10 can improve cholesterol efflux from     macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In     addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria     electron transport chain. So the investigators hypothesize that CoQ10 may have some health     promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular     diseases. On this purpose, the investigators are going to recruit 150 dyslipidemia patients     to supply CoQ10+vitamin E or CoQ10 alone or placebo in different doses for 24 weeks to     explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.   "
67095|NCT02407522|"     The purpose of this study is to thoroughly investigate how the interaction between black rice     and human gut microbiota affects metabolic diseases, this study will recruit patients with     Metabolic Syndrome (MS) and provide them with dietary supplementation of black rice (50     g/day) for 3 months to observe its effect on the development of MS. The focuses of this     project are to elucidate how black rice consumption affects the composition and metabolism of     intestinal bacteria as well as the development of MS, and to further analyze whether the     changes in intestinal bacteria are associated with the changes in MS improvements.   "
67096|NCT02407509|"     RO5126766 will be administered initially as a single daily dose of 4mg using either a twice     weekly dosing schedule (Monday-Thursday) or a 3 times per week dosing schedule     (Monday-Wednesday-Friday). The daily dose will be given orally according to the dosing     schedule. A cycle of treatment will comprise 28 days. In Part I of the study both the twice     weekly and the three times per week schedules will be assessed. In the absence of dose     limiting toxicities 6 patients will be recruited to each dosing schedule cohort. In the event     of a DLT being observed in Part I of the study, a single dose reduction to 3.2 mg will then     be instigated and up to 6 patients will be recruited to that dosing schedule at the lower     dose. The optimal dosing schedule determined in Part I will be taken forward to Part II and     20 patients with tumours harbouring BRAF, KRAS and NRAS mutations will be enrolled.   "
67097|NCT02407496|"     The purpose of this study is develop a new assessment tool for Attention     Deficit-Hyperactivity Disorder (ADHD) and to then test its validity (i.e. ability to     discriminate between individuals with ADHD and healthy controls).   "
67098|NCT02407483|"     Laparoscopic simulation training with or without laser visual guidance -A randomised study     which investigates if the use of laser visual guidance can help the novices to learn the     laparoscopic skills.   "
67099|NCT02407470|"     RATIONALE: It has been shown that about 30% of patients do not respond to immunosuppressive     therapy or experience recurrence, and graft rejection and graft-versus-host-disease (GVHD)     decrease event-free survival to 30% to 50% in the alternative donor (matched unrelated,     partially matched family member) transplantation. Although an overall and disease free     survival of 85% to 100%, can be obtained in allogeneic blood or bone marrow stem cell     transplantation using an human leukocyte antigen (HLA) matched sibling donor, only about 25%     of patients have such a donor.      PURPOSE: In an attempt to avoid GVHD, reduce earlier infection rate and decrease     regimen-related toxicity while maintaining better engraftment, this study is to evaluate the     effectiveness and safety of patient's own adipose-derived mesenchymal stem cell (AD-MSC) or     AD-MSC transdifferentiated HSC (AD-HSC) transplant after an immunosuppressive regimen in     treating patients who have severe aplastic anemia.      The patient will be in the study for one year for observation and active monitoring. After     treatment and active monitoring are over, the patient's medical condition will be followed     indefinitely. The principle measures of safety and efficacy will be :        1. Patient survival probability at 3 months, 6 months and 1 year.        2. Engraftment at 3 months, 6 months and 1 year        3. Incidence of graft versus host disease (GVHD), incidence of acute and chronic GVHD and          Incidence of earlier infection rate as well as other complications within 6 months and 1          years.   "
67103|NCT02407418|"     The purpose of this study was to investigate the effects of chiropractic low back adjustments     on thigh muscle strength. Force production was measured during different types of muscle     contractions with a device called an isokinetic dynamometer. The study included 21     college-aged subjects who did not have any pain and had never received chiropractic treatment     with spinal manipulation. During two separate sessions, subjects' thigh muscle forces were     recorded while performing maximal muscle contractions on the isokinetic dynamometer. Baseline     measurements of muscle force were acquired before either treatment form of spinal     manipulation or a sham spinal manipulation, followed by identical muscle force measurements     within five and twenty minutes post-treatment.   "
67104|NCT02407405|"     This phase II trial studies how well selumetinib works in treating patients with     neurofibromatosis type 1 and plexiform neurofibromas (tumors which arise from the nerves)     that cannot be removed by surgery (inoperable). Selumetinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
67105|NCT02407392|"     Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people     in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which     only 5% of patients will survive for 5 years after diagnosis. Diagnosing the disease at the     stage of dysplasia (pre-cancerous) and early cancer improves survival. This has led to the     current surveillance strategy of gastroscopy with non-targeted mapping biopsies taken from     the Barrett's oesophagus every two years. The large number of biopsies required is time     consuming and expensive, yet dysplasia and cancerous tissue is still missed due to the     non-targeted biopsy sampling strategy. Acetic acid has been used effectively in the early     detection of cervical dysplasia and cancer, and has also been used with success in a high     risk Barrett's population (patients with suspected dysplasia or previously treated     dysplasia), but not been studied in the lower risk Barrett's surveillance population. A     diagnostic study of non-targeted mapping biopsies (current practice) versus targeted biopsies     (acetic acid) in a surveillance population is needed before widespread adoption of this     technique is possible.   "
67106|NCT02407379|"     The purpose of this study is to compare the efficacy of photoablative and photodynamic diode     laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of     periodontitis.   "
67107|NCT02407366|"     The current standard of care for unresectable locally advanced non-small-cell lung cancer     (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard     regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the     first self-developed small molecular drug in China for targeted therapy of lung     cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in     Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised,     multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with     concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in     inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is     progression-free survival.   "
75418|NCT02298634|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Farber     disease from plasma and saliva. Testing for clinical robustness, specificity and long-term     stability of the biomarker.   "
67109|NCT02407340|"     This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new     medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and     women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial.     Participants will complete an 7-day inpatient protocol. During the first 3 days of the     inpatient protocol, participants will complete alcohol abstinence in which withdrawal     symptoms are measured,and urine will be collected to determine withdrawal symptom severity     and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory     procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective     and physiological effects of alcohol. Finally, because participants are individuals with AUD,     we will administer a brief intervention to address their risky alcohol drinking and problems     before discharge.   "
67110|NCT02407327|"     The purpose of this study is to determine the percentage of CTC-positive patients and total     CTC numbers in patients with advanced Non Small Cell Lung Cancer .   "
67111|NCT02407314|"     This is an interventional study assessing the effectiveness of Ticagrelor on the reduction of     thrombus burden using optical coherence tomography in patients undergoing peripheral artery     stenting.   "
67112|NCT02407301|"     This project is a first attempt to assess cough airflow dynamics and true vocal fold (TVF)     adduction and abduction angles during voluntary cough to examine the effects of changes in     glottal closure due to reduced mobility of one true vocal fold. The hypothesis of this study     is that the incomplete glottal closure due to reduced vocal fold mobility will result in     changes in true vocal fold adductory and abductory angles during cough and will result in     changes to voluntary cough airflow parameters. This study results will contribute to the     existing knowledge of the laryngeal contribution to cough airflow dynamics.   "
67113|NCT02407288|"     The purpose of this study is to determine whether tDCS is effective as an add-on treatment in     SSRI-resistant patients with obsessive and compulsive disorder   "
67114|NCT02407275|"     To analyse and describe sinus microbiota, during hard to treat (or refractory)     rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different     medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA     contained in samples).      Samples are middle meatus swabs or pus aspiration, done during usually patient following.   "
67128|NCT02407093|"     Although soldiers must be ready to respond to occupational and war theatre demands at a     moment's notice, there is an epidemic of overweight and obesity and a need for improved     fitness and health in the military. Using a cluster randomized clinical trial we propose to     test the effectiveness of a High-Intensity Functional Training (HIFT) exercise intervention     to improve the body composition and fitness of active duty military personnel. The     effectiveness of the HIFT intervention will be compared to usual Army Physical Readiness     Training. Main outcomes will include changes in body composition and traditional fitness     measures, a test of combat-preparation, and measures of cardiovascular health risk for both     groups.   "
67115|NCT02407262|"     Traditionally, Black Seed (Nigella sativa) is a well-known food supplement and herbal product     that has a wide range of medical claims (including asthma) that originate from different     historical backgrounds. Today in the era of Evidence-based medicine, it is hard to accept     those traditional medical claims of medicinal plants without valid scientific experiments.     Thus, randomized clinical trials is important to rational the uses of herbal products.      Asthma is a common chronic disorder of the airways, characterized by variable reversible and     recurring symptoms related to airflow obstruction, bronchial hyper-responsiveness, and     underlying inflammation. In Saudi Arabia, Asthma is considered one of the leading chronic     diseases affecting more than 2 million Saudi citizens. The global Asthma Report 2014     considered Asthma as an epidemic disease probably affecting about 334 million people     worldwide and becoming a global health priority.      This project investigates the use of herbal products to enhance asthma control in Saudi     Arabia. In this context, Black Seed is one of the common herbal products used traditionally     for asthma in the Saudi region. Black seed is a common unconventional therapy used among 10%     of Asthmatic patients in King Abdulaziz Medical city, Riyadh. In fact, there are some     pre-clinical evidence and preliminary clinical studies support the usefulness of Black seed     in Asthma and its underlying causes   "
67116|NCT02407249|"     This is a control registry to the E-FIRM registry to track conventional atrial fibrillation     (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for     the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as     pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard     routine of the center.      Data items will be collected, if available, consistent and applicable with routine and     standard clinical care at each participating site.   "
67117|NCT02407236|"     The purpose of this study is to evaluate the efficacy and safety of ustekinumab as     intravenous (IV: into the vein) infusion in induction study in participants with moderately     to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in     maintenance study in participants with moderately to severely active Ulcerative Colitis (UC)     who have demonstrated a clinical response to Induction treatment with IV ustekinumab.   "
67118|NCT02407223|"     The purpose of this study is to assess the efficacy and safety of ustekinumab in adult     participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the     reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).   "
67119|NCT02407210|"     To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in     patients with grade I or II essential hypertension   "
67120|NCT02407197|"     Myocardial fibrosis is the fundamental substrate for the development of heart failure.      Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis     based on late gadolinium enhancement (LGE) and T1 mapping.      Patients: Prospective longitudinal observational multicenter study of consecutive patients     with suspected or known non-ischemic cardiomyopathy.      Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume     fraction (ECV) and LGE.      Primary endpoints: all cause and cardiovascular mortality.      Secondary endpoints: arrhythmic composite and HF composite endpoints.   "
67170|NCT02406547|"     This study is designed to evaluate the utility of Narrow Band Imaging (NBI) compared with     High Definition White Light colonoscopy (WLE) in subjects with serrated lesions who do not     fulfill the diagnostic criteria of Serrated Polyposis Syndrome (SPS).   "
67122|NCT02407171|"     This is a 2-part prospective trial examining the ability of Stereotactic Body Radiation     Therapy (SBRT) to induce a response to MK-3475, a humanized antibody to PD-1, in patients who     progress on this antibody. Patients with metastatic melanoma will be enrolled after they have     progressed on anti-PD-1 therapy. Patients with metastatic NSCLC (previously untreated with     anti-PD-1 or anti-PD-L1 therapy) will be enrolled and treated with MK-3475 until they exhibit     progression of disease. At this point (when patients have demonstrated progression of     disease) a single target lesion will be selected and treated with SBRT, and then MK-3475 will     be restarted and continued until there is further progression of disease. The first phase of     the study is a radiation dose escalation with a constant dose of MK-3475. The second part of     the study includes expansion cohorts of NSCLC and melanoma patients.   "
67123|NCT02407158|"     The investigators will compare the response to oral endotracheal tube repositioning as     measured by chest x-ray and measured by the air-wave device.   "
67124|NCT02407145|"     This study is designed to evaluate the safety and efficacy of low elasticity polyvinylidene     fluoride (DynaMesh®-SIS soft) retropubic tension-free midurethral slings in the treatment of     stress urinary incontinence in women. Women who are having a retropubic PVDF midurethral     sling for urodynamic stress incontinence will be followed up for 24 months to address its     efficacy and rate of complications.   "
67125|NCT02407132|"     The investigators will conduct a comparative effectiveness evaluation using a randomized     control trial design of the adapted Family Model of Diabetes Self-Management Education     (DSME), and compare results of the Family Model of DSME with traditional DSME within the     Marshallese population. The family model will cover the same concepts as the traditional     format. However, the family model will incorporate culturally-adapted education and     recommendations aimed at engaging family members in the management of the primary     participant's diabetes, and family members will be invited to fully participate in the study.     By contrast, the traditional model provides diabetes self- management education to the     diabetic participant only, and the participant's family members do not participate in the     classes or any other part of the study. Biometric and survey data will be collected     pre-intervention, post-intervention, 6 months post-intervention, and 12 months     post-intervention. A qualitative debriefing session will be held for each family between the     final DSME session and the 6 month post-intervention to obtain qualitative data regarding the     participant's perceptions of the intervention and implementation process.   "
67126|NCT02407119|"     This study evaluates whether Helicobacter pylori eradication improves precancerous lesions     including glandular atrophy and intestinal metaplasia as well as new cancers or dysplasias     after endoscopic mucosal resection for gastric cancer.   "
67127|NCT02407106|"     The purpose of this study is to determine whether daily treatment with Streptococcus     Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an     episode of rheumatic fever.   "
67129|NCT02407080|"     This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera     (PV). ET causes people to produce too many blood cells called platelets and PV causes too     many platelets and red blood cells to be made. Platelets are particles which circulate in the     blood stream and normally prevent bleeding and bruising. Having too many platelets in the     blood increases the risk of developing blood clots, which can result in life threatening     events like heart attacks and strokes. When the number of red blood cells is increased in PV     this will slow the speed of blood flow in the body and increase the risk of developing blood     clots.      The purpose of Part A of this study is to test the safety and tolerability of drug RG7388     patients and identify the recommended phase II dose in a single agent dose escalation study.     The investigators want to find out what effects, good and/or bad it has on the disease.      The purpose of Part B of this study is to test the safety and tolerability of the combination     of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from Part A who did     not achieve at least a partial response by the end of three cycles of single agent RG7388.      Essential Thrombocythemia (ET) and Polycythemia Vera (PV) have been difficult diseases to     treat. RG7388 is a selective inhibitor of the p53-MDM2 binding that frees p53 from negative     control and activates the p53 pathway in cancer cells, leading to cell cycle arrest and     apoptosis in vitro and in vivo. It has been used to treat solid tumors and Acute Myelogenous     Leukemia (AML) in clinical trials. Pegasys is a drug that is the standard of care for     patients who have Chronic Hepatitis B (CHB).      RG7388 is a drug that is not yet approved by the Federal Drug Administration (FDA) for the     treatment of patients with essential thrombocythemia or polycythemia vera. Pegasys is a drug     that is approved by the FDA for the treatment of CHB. The use of RG7388 alone and in     combination with Pegasys is experimental.   "
67130|NCT02407067|"     This study will compare two types of assistive devices for communication (a voice amplifier     and a personal communication system) in individuals with a speech disorder related to     Parkinson's disease. The performance of these two devices will be examined with measures of     speech intelligibility and patient questionnaires and rating scales.   "
67131|NCT02407054|"     The main purpose of this study is to evaluate the safety and effectiveness of the study drug     known as LY3023414 in combination with enzalutamide in men with prostate cancer.   "
67132|NCT02407041|"     Study GT-030 is a phase 2a, single-center, open-label study of subjects with moderate to     severe plaque psoriasis   "
67133|NCT02407028|"     The purpose of this innovative adaptive phase II trial design is to determine the optimal     hyperbaric oxygen (HBO2) treatment paradigm to be instituted in terms of atmospheric     pressure, frequency of treatment and whether normobaric hyperoxia (NBH) following HBO2     treatments enhances the treatment effect.   "
67134|NCT02407015|"     This study aims to examine the specific effect that 3D game play has on the control of the     eyes horizontal movements. It will examine the youngest group of consumers this technology is     marketed to, 7 to 11-year-olds and no children under 7 years of age will be recruited to this     study as per Nintendo's hardware guidelines, which recommends that children under 7 years of     age not play in 3D mode. It will examine the effect of playing in 3D for 30 minutes on     horizontal fusional amplitudes compared with a control group playing in 2D for 30 minutes.   "
67135|NCT02407002|"     The purpose of this study is to quantify the risk of hypotension due to field treatment with     nitroglycerin in patients with ST-elevation myocardial infarction, particularly right     ventricular infarcts, and secondarily to evaluate the benefit to pain relief..   "
67136|NCT02406989|"     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of     MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics.     Subjects are dosed for 14 days.   "
67137|NCT02406976|"     This objective study to verify the effect of physical training with and without behavioral     cognitive therapy, compared with controls, in functional capacity and cardio-metabolic     profile in individuals with morbidly obese   "
75419|NCT02298621|"     The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic     syndrome.   "
67138|NCT02406963|"     A pilot research study is planned to occur within the pediatric urology service the spring of     2015. All pediatric urology patients in the immediate post-operative period of 0-14 days will     be eligible for this study. This study will compare the current standard of care for managing     post-operative complications (a telephone conversation with the NP) versus an experimental     intervention (telephone call and an electronic photograph of the surgical site). Before the     surgical patient is discharged from the hospital, consent will be obtained for participation.     Once a family initiates contact with the NP with a post-operative concern they will be     randomized to either the control or the experimental group. Those in the control group will     receive the current standard of care, which is telephone advice only. Those in the     experimental group will speak to the NP on the telephone and will be requested to send an     electronic photograph of their child's surgical site to the NP for assessment and advice.     Photographs will be assessed using a standardized tool by both NPs and this information will     be entered into a database. The investigators will be measuring the number of emergency     department (ED) and/or unplanned clinic visits in both groups. An unplanned clinic visit is     defined as a visit that is required due to an unexpected complication or concern before the     original scheduled post-operative follow-up as determined by the surgeon. The investigators     will be tracking the number of follow-up phone calls for both groups, as well as requiring     participants to complete a family/patient experience survey after speaking to the NP.   "
67139|NCT02406950|"     Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal     ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects     against endothelial dysfunction induced by IR injury in humans.   "
67140|NCT02406937|"     180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed in     study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3 groups,     including breast feeding, commercial and new formula group. Study intervention is 12 weeks.   "
67141|NCT02406924|"     Twenty four patients with bone resorption on the anterior maxilla will be divided into two     groups with different kinds of grafting: bone block associated with particulated biomaterial     and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane     and pins. The techniques will be compared according to volume gain, quality of graft     osseointegration, implant survival and maintenance of the level of soft tissues.   "
67142|NCT02406911|"     Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD)     is still challenging because of bleeding and thrombotic complications. The investigators     hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared     with ticagrelor twice a day dose in ESRD patients on HD.   "
67161|NCT02406664|"     The purpose of this study is to determine the change in kidney function and blood pressure     after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly     focus on glomerular filtration rate(GFR) with known relation to the renal function and 24     hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical     treatment.   "
67143|NCT02406898|"     Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma.     Limit of this technic is duration of procedure which is correlated to operative     complications. So, for patient with large fibrome or several fibromas, this technic is not     indicated or performs in several times. A new technic of hysteroscopic surgery is available     which is quicker than conventional technic. This technic is poorly evaluated. Aim of this     study is to evaluate both technics on procedure duration.   "
67144|NCT02406885|"     The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of     apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE)     prophylaxis and treatment) in the obese adult population to determine if bariatric surgery     influences apixaban exposure. More interesting would be to see how the dose may need to     change pre- vs. post-bariatric surgery (this will be important for physicians as more and     more patients undergo this procedure worldwide and many may require anticoagulation in their     future healthcare).      Physicians and surgeons are very interested in oral anticoagulants for this special patient     population. To date, there is no approved dosing for the obese patient (especially when     considering surgical intervention such as bariatric surgery).      Primary outcome variable.      To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in     patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two bariatric     surgical procedures (pre-operative versus post-operative vertical sleeve gastrectomy or     Roux-en-Y gastric bypass patients).      Secondary outcome variables.        1. To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric          surgical patients who have undergone RYGB vs. VSG.        2. To determine how the pharmacokinetics of the drug may differ when there is significant          post-operative surgical weight loss (>40% estimated excess body weight) 12 to 18 months          following surgery versus those patients who have suboptimal weight loss following          bariatric surgery (< 40% of estimated excess body weight).   "
67145|NCT02406872|"     The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an     intravenous general anaesthetic drug in operations and to determine its efficacy and safety     profile comparing to propofol.   "
67171|NCT02406534|"     This is an observational study to evaluate the relationship between pulmonary function and     the patient reported health-related quality of life (HRQoL) and chronic obstructive pulmonary     disease (COPD) related admissions. Patients with COPD will be approached to participate in     the study. Pulmonary function will be measured on consented, eligible patients. The pulmonary     function measurement collected will be used for cohort assignment. The prospective follow up     period will monitor the cohorts for evidence of readmission and to assess HRQoL.   "
67172|NCT02406521|"     This research study is comparing different drug combinations as a possible treatment for     metastatic renal cell carcinoma (mRCC) and bone metastases.      The names of the study interventions involved in this study are:        -  Combination of Radium-223 and Sorafenib        -  Combination of Radium-223 and Pazopanib   "
67173|NCT02406508|"     This is a single arm, open label, multi-center, phase 2 study to evaluate the safety and     efficacy of sequential treatment with Melphalan/HDS followed by sorafenib in patients with     unresectable hepatocellular carcinoma (HCC) confined to the liver.   "
67174|NCT02406495|"     Open label, 1-week daily disposable, dispensing study   "
67146|NCT02406859|"     An injury to the spinal cord results in a number of secondary medical problems, including the     inability to voluntarily control the bowels. Depending on the severity and location of the     injury, remaining bowel function differs, and can include any combination of the following:     constipation (prolonged stool retention), difficulty with evacuation (difficultly moving     bowels), fecal incontinence (problems retaining stool until it is appropriate to move the     bowels). Most of the current medications and treatment options address problems of     constipation and difficulty with evacuation, but there are few options for individuals who     suffer from incontinency. In this study, the investigators propose to study, in detail,     anorectal muscle function in individuals with spinal injury - the investigators will do so     using new technology called high resolution manometry - which will present the investigator     with a 3 dimensional representation of the pressure profile of the anorectal muscles as the     subject attempts different maneuvers. A subgroup with representatives of all levels and     completeness of injury and anorectal muscle function will be enrolled to participate in six     weeks of biofeedback training to see if their bowel function can be improved. During these     six weeks, the subjects will be asked to visit the laboratory twice a week in order to be     trained by the research team on how to improve their anorectal strength and function in     response to visual cues. After the six weeks, another manometry study will be performed.     Subjects will then be sent home and asked to perform a series of home exercises for another 6     weeks, after which they will asked to return for a third and final manometry study.   "
67147|NCT02406846|"     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in     pancreatic cancer could play an important role in diagnosis, predicting the risk for tumor     recurrence, and providing novel target therapy biomarkers.In view of these facts, We wanted     to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of     pancreatic cancer in normal peripheral blood after cryosurgery with or without dendritic     cell(DC)-cytokine-induced killers(CIK) treatment, and we also compared the specificity with     reverse transcriptase polymerase chain reaction (RT-PCR) method.   "
67148|NCT02406833|"     This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2,     to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery     outcome by prevention of excessive scarring and trabecular meshwork transformation.   "
67149|NCT02406820|"     HF001 is a prospective observational study utilizing non-invasive medical devices that may be     able to discriminate changes in heart failure while acutely decompensated patients undergo     routine interventional therapies in a hospital setting. Subjects will be monitored using     CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric handgrip     stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to standard     assessments of heart failure including pulmonary artery catheter (PAC) pressures, blood     pressure (BP), patient symptoms, and physical exam findings. The results of this study will     be used to develop a powered study to determine if a new configuration of non-invasive     monitoring devices can be used to monitor heart failure status more sensitively than current     non-invasive techniques.   "
67150|NCT02406807|"     High-Velocity Low-Amplitude (HVLA) manipulation is a known technique of the Osteopathic     Manipulative Treatment (OMT) for somatic dysfunction (SD), and heart rate variability and     H-reflex response are possible variables to assess its neurophysiological effects. Somatic     dysfunction is an impairment or altered function of related components of the somatic system.      Studies show a transient attenuation of α-motor neuron excitability after HVLA manipulation     in asymptomatic participants. According to studies, HVLA spinal manipulation increases joint     mobility by blocking afferent impulses in the muscle spindle and the small-diameter free     nerve, decreasing the γ-motor neuron activity.   "
67162|NCT02406651|"     A Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of     F-652 in combination with systemic corticosteroids in subjects who have undergone     Hematopoietic Stem Cell Transplantation (HSCT) and have newly diagnosed grade II-IV lower GI     acute Graft Verses Host Disease (aGVHD). Treatment with F-652 will be once a week for 4     weeks, with post treatment follow up visits on days 28, 56, 180 and 365.   "
67151|NCT02406794|"     Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than     tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the     side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study     aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia     and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve     their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various     points in order to improve symptoms and increase adherence.      Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy     (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria     Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment.     Clinical and patient data were obtained from medical histories, genetic and proteomic     analysis, grip strength and algometry measured, questionnaires and the outcome of interest,     their VAS. NMT is applied in four possible locations, according to the symptoms of each     participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more     interventions before repeating the readings from the last five weeks of the start of the     study.   "
67152|NCT02406781|"     This is a multicenter study assessing efficacy of the MK 3475 (Pembrolizumab) in combination     with metronomic cyclophosphamide in patients with advanced sarcomas.   "
67153|NCT02406768|"     To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use     this group to compare the neurodevelopmental changes over time to the HIV-infected children     with and without HAART (main study).   "
67154|NCT02406755|"     Randomized clinical trial about self-care mediated by the senses in female health     professionals and their influence on stress, self-esteem, mood states, life satisfaction and     levels of salivary cortisol.   "
67155|NCT02406742|"     Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with     ibrutinib and obinuzutumab.      CC-122 has multiple activities, including immune modulation of several immune cell subsets     and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety     profile with some preliminary signs of efficacy with early human experience.   "
67156|NCT02406729|"     This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will     evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine     produced by Butantan Institute.      The study will be carried out in multiple sites in Brazil. The study will be community-based     in select urban areas where there's dengue transmission.      Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a     ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days     post-vaccination in the entire population of 16944 participants.      For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys     and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The     age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21     days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following     group, of 2 to 6 ys, will start.      The study's hypothesis is that the vaccine under investigation and produced by Butantan     Institute is safe and provides protection against dengue symptomatic disease of 80% or more     with a lower bound of the 95% confidence interval of 25%. This way, the expected number of     dengue cases virologically confirmed is 24 or more which will provide a response in terms of     vaccine efficacy.      All participants will be followed up for five years to verify dengue incidence, regardless     severity.   "
67157|NCT02406716|"     This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with     heart failure. Study protocol:      Hospitallized patients with new onset or previously diagnosed heart failure will be recruited     to the study. Control group will include healthy people with no medical records or chronic     treatment at the same age range. After signing an informed constent form, full medical     history and blood samples will be collected. A second blood sample will be collected 8 weeks     later, assuming the patient was discharged and not hospitalized since than. The blood samples     will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels     in the heart failure group and control group. Statistical analysis will then commence for     possible correlatoion with different clinical parameters.   "
67158|NCT02406703|"     Background and Objectives Short acting regional anesthetics have already been successfully     employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on     direct and indirect perioperative costs comparing two different short-acting local     anesthetics has not been performed, yet.      Methods In an observational study including 50 patients per group, patient undergoing     popliteal block with chloroprocaine 3% or mepivacaine 1.5% for ambulatory minor foot surgery     were compared. The primary outcome was the saving of both direct and indirect perioperative     costs. Secondary outcomes were block success, onset time and block duration, patient     satisfaction and unplanned outpatient visits or readmissions after discharge.   "
67159|NCT02406690|"     The purpose of this study is to determine the differences that exist in RNA molecules, the     biochemical process of methylation, and estrogen receptor binding in patients that have     failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to     patients whose endometrium thickness is within normal limits.   "
67160|NCT02406677|"     Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the     impact of copayment reduction on clinician choice of medication, patient adherence, and     clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical     trial that will assess the impact of copayment reduction by equalizing the copayment of     clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication     adherence, and clinical outcomes up to one year. We hypothesize that reducing out--of--pocket     cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment     reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk.     This is in part due to greater adherence to an evidence--based secondary prevention     medication. Additionally the reduction in MACE may reflect greater selection of a more potent     antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as     provider choice of antiplatelet therapy will be primarily driven by risk- benefit assessment     rather than the cost burden to the patient.   "
67163|NCT02406638|"     Compare through 3D USG the tape spatial orientation, in three different techniques of     insertion of mid-urethral synthetic sling, correlating USG findings to postoperative results     in an average of three years follow-up.      Methods: This is a transversal study of a cohort women surgically treated for stress urinary     incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision     sling (TVT-S). The clinical and USG evaluation were performed at the same medical visit, from     April 2013 to June 2014, .   "
67164|NCT02406625|"     Suicidal behaviors among adolescents represents a public health problem due to its high     prevalence and its low predictability. It is also known that brain development continues     during adolescence, therefore, a therapeutic intervention during this period might propitiate     neural changes that might favor the emotional regulation involved in suicidal behaviors.     Dialectical Behavioral Therapy has proved to be effective regarding this problem.      For this reason, the investigators aimed to study the clinical, neuropsychological and neural     effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.   "
67165|NCT02406612|"     The study is designed to prospectively collect data on and confirm the safety and     effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and     time to ambulation for patients who have undergone diagnostic or interventional     catheterization procedures using up to 6F sheaths when compared with standard compression     techniques using data from literature surveys.   "
67166|NCT02406599|"     The study objective is to determine the MarginProbe® System's diagnostic accuracy at the     margin level and impact on Positive Margin* Presence originating from the Main ex-vivo     lumpectomy specimen after the initial lumpectomy surgery.      *A positive margin is defined in this study as a margin microscopically measured and reported     in the histology report to have cancer within 1 mm or less of the inked surface   "
67167|NCT02406586|"     The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated     inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty     acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and     oxidative stress, and autonomic dysfunction in obese normotensive subjects.   "
67168|NCT02406573|"     This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity     response relative to a clinically-controlled stimulus.   "
67175|NCT02406482|"     This study will examine the efficacy of a combined HIV and microfinance intervention to     reduce biologically confirmed sexually transmitted infections (STIs), and new incidence of     HIV and HCV, as well as reported sexual and drug risk behaviors among 520 women who have     injected drugs in the past year and who engage in sex trading in Temirtau and Pavlodar,     Kazakhstan. The proposed study builds on findings from an R34 by the investigative team     testing a combination HIV prevention and microfinance intervention. Building on successful     protocols and significant results, we will randomly assign 520 women who inject drugs and     engage in sex trading from Temirtau and Pavlodar, Kazakhstan to either (1) a 4 session HIV     prevention intervention combined with a 6 session financial literacy intervention, enrollment     in an existing vocational training program and receipt of matched savings (HIVRR+MF); or to     the 4 session HIV prevention intervention alone. The HIVRR intervention is guided by social     cognitive theory. The HIVRR+MF intervention integrates asset theory with social cognitive     theory. The MF includes: 1) financial literacy; 2) vocational training; and 3) micro-savings     to support transition to a more permanent employment status. We hypothesize that increasing     financial literacy, enhancing vocational skills required to fill marketable positions in the     local economy, and beginning a personal savings program, combined with HIV risk reduction,     will lead to significant reductions in study outcomes compared to an HIVRR intervention     without a microfinance intervention.   "
67176|NCT02406469|"     This is a single-site, double-blinded, randomized, controlled, 2X2 cross-over study aiming to     compare effects of milk containing only A2 type beta casein versus milk containing both A1     and A2 beta casein proteins on the gastrointestinal physiology, symptoms and cognitive     behaviour for the health people who are intolerant to traditional cow's milk.   "
67177|NCT02406456|"     Participants will undergo a single session of functional magnetic resonance imaging     (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their     ability to regulate motivational networks of the brain during the exposure to alcohol cues     and evaluate immediate effects on craving and cognitive bias for alcohol by administering a     questionnaire and a Stroop task before and after the session.   "
67178|NCT02406443|"     Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4     inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the     mechanisms mediating the renal effects of DPP-4 inhibitors in humans.      Objectives: To evaluate the effect of DPP-4 inhibition acutely (single dose) and following     short-term therapy (28 days) on renal sodium handling and renal hemodynamics and function in     patients with type 2 diabetes and systolic hypertension.      Design: double-blind, randomized, placebo-controlled trial, Phase IV.      Patient population: 32 patients with Type 2 diabetes, HbA1c (6.5%-9%), with systolic blood     pressure ranging from 120-160 mmHg.      Intervention: subjects will be randomized (1:1) to either sitagliptin (100 mg daily) or to     placebo (1 tablet daily) for 28 days.      Endpoints: Fractional excretion of sodium, renal function, and renal hemodynamics.   "
67179|NCT02406430|"     Retrospective interventional case series study reporting preoperative clinical and anatomical     factors associated with visual recovery 1 year after combined cataract and idiopathic     epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected     visual acuity appeared to be reliable prognostic factors. Combining these factors with     analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical     coherence tomography provides a predictive score to estimate individual chances of good     visual recovery   "
67180|NCT02406417|"     Early detection and management of pituitary dysfunction reduces the morbidity that ensues as     a consequence of missed or delayed diagnosis of this condition, and which may result in     life-threatening events and increased mortality.      The investigators study will explore the use of reflex strategies within the laboratory in     capturing suspicious pituitary function test results from Primary Care patients and following     these up with appropriate reflective testing. Subsequently patients identified from these     results to have a possible underlying piuitary dysfunction will have an alert sent to their     family physician prompting referral to the Endocrine team for further investigation and     management.   "
67181|NCT02406404|"     This study was designed to examine the effect of incentive spirometry in pulmonary     rehabilitation of children with cerebral palsy. The incentive spirometer, a device that can     help improve breathing and strengthen inspiratory muscles. If the patient assigned to     training group, the subjects started to respiratory muscle strengthening exercise using     incentive spirometry. The training was performed ten sessions daily, for 4 weeks. Respiratory     function tests including forced vital capacity, forced expiratory volume in 1 second, Peak     cough flow, maximal phonation time were compared before interventions and at the end of     exercise.   "
67182|NCT02406391|"     In the United States, the highest incidence of cervical cancer occurs in inner city urban     centers, rural areas, the deep South, Appalachia and the U.S.-Mexico border. The goal of this     study is to study predictors of adherence among patients seeking care at an inner city     medical center in New York City and the U.S. Mexico border for cervical cancer prevention,     namely, Pap smears and colposcopy exams.   "
67183|NCT02406365|"     A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid     detection and management of cervical lesions. The handheld research device captures cervical     images which with the fluorescent light show the regions of cervical tissue that     autofluoresce. The investigators will study the relationship between the level of     fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her     routine care. The investigators will also compare the efficacy of the hand held device with     the data being collected from the other research devices being tested by the team, i.e. the     multispectral digital colposcopes.   "
67184|NCT02406352|"     Although cervical cancer is a preventable cancer, every year more than one-quarter of a     million women die worldwide from this disease. Internationally and nationally, cervical     cancer is a disease that affects predominantly women who are poor and who live in resource     poor settings. With the device the investigators are developing, known as the Multispectral     Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions     easier for the patient and for her provider. For the patient, our goal is to reduce the     number of clinical visits needed to obtain a diagnosis and treatment and consequently to     reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For     the provider and the health care system, our goal is to obtain a more accurate diagnosis than     the currently available diagnostic methods.   "
67188|NCT02406300|"     This study evaluates the effect of anesthesia on mortality after surgical repair of proximal     femur fracture.      Patients will receive either a subarachnoid block or a combination of peripheral nerve blocks     and light general anesthesia (PNB/GA).      The investigators hypothesis is that a combination of peripheral nerve blocks with an opioid     free light anesthesia may have more favourable outcomes.      Both groups will be followed up for assessment of post-operative morbidity and mortality.   "
67189|NCT02406287|"     To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics     relative to its placebo.   "
67190|NCT02406274|"     Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is     performed after injection of contrast or dye into a vein in the arm. This dye is the same dye     that is used for CT scans. This type of mammogram includes a regular mammogram as well as     additional pictures with the dye.      This particular study is being done to determine if by adding the dye in the veins the     investigators are better able to identify the cause of the lump than if they just did the     regular mammogram alone.   "
67195|NCT02406209|"     This is a randomized, multi-center, investigator masked, comparator controlled study. The     purpose of this study is to determine the efficacy and safety of NS2 in patients with     non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple     doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.      Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a     small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.   "
67196|NCT02406183|"     The prognosis of advanced metastatic melanoma remains poor although a breakthrough has been     achieved with the novel anti-CTLA-4 treatment (ipilimumab) for a subset of patients.     Unfortunately, due to immune resistance, the majority of patients do not obtain long-lasting     clinical benefit. Radiotherapy is able to interfere with immune resistance by inducing     immunogenic cell death. Preclinical evidence indicates that combining radiotherapy with     anti-CTLA-4 treatment increases response rates compared to single agent treatment. These data     are supported by several spectacular clinical cases and one retrospective study. The     investigators hypothesize that combining ipilimumab with radiotherapy will result in a higher     response rate compared to ipilimumab or radiotherapy in monotherapy. Given the complexity of     the interaction in anti-tumor immunity, the first goal of this project is to assess the     safety of the combined treatment.   "
67197|NCT02406170|"     Patients with advanced oesophagogastric cancer (OCG) have a very poor prognosis. After     progression on first line therapy, second line chemotherapy with paclitaxel and a VEGF-R2     targeting antibody has a proven benefit on survival. However, no data are available on the     combination of paclitaxel with kinase inhibitors in advanced OGC. Here the investigators     propose a Phase 1b study to assess the tolerability of regorafenib (an oral multi kinase     inhibitor) in combination with paclitaxel and to assess the uptake of paclitaxel in OCG     metastasis.   "
67198|NCT02406157|"     This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic     efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema     compared with 532 subthreshold laser photocoagulation.   "
67199|NCT02406144|"     This protocol is a randomized, open-label, national, multicenter trial studying maintenance     treatment with lenalidomide and dexamethasone versus lenalidomide, dexamethasone and MLN9708     after autologous hematopoietic stem cell transplantation in patients with newly-diagnosed     symptomatic multiple myeloma.      A total of 316 patients, from the study GEM2012MENOS65, will be enrolled in the study.      The pre-treatment period includes the screening visit in which participants provide informed     consent in writing in order to take part in the study. The patient is then assessed to     determine his/her eligibility. The selection process will begin 21 days before the first dose     of medication is administered (days -21 to 0). All procedures during the pre-treatment period     will be carried out after completion of the two cycles of post-transplant consolidation with     VRD which coincide with the end-of-study visit of clinical trial GEM2012MENOS65.      During the treatment period, eligible patients will be included in the study and receive     maintenance treatment with lenalidomide/dexamethasone versus     lenalidomide/dexamethasone/MLN9708. Each cycle will last 28 days. Treatment arm A will     consist of oral administration of 15 mg/day of oral lenalidomide on days 1-21, and 20 mg/day     of dexamethasone administered orally on days 1-4 and 9-12 for a period of two years. Arm B of     the maintenance treatment will be the same as arm A, with the addition of MLN9708 during the     two year maintenance period, at a dose of 4 mg/day on days 1, 8 and 15 of the cycle.      At two years, patients with negative MRD will finish maintenance treatment. Patients with     positive MRD will continue treatment with lenalidomide/dexamethasone until they have     completed five years of maintenance treatment. In this case, 20 mg/day of dexamethasone will     only be administered on days 1-4 of the cycle. The dose of lenalidomide will not be adjusted.     (unless necessary to treat adverse events)      Once this phase of active treatment is complete, patients will begin the long-term follow-up     phase, during which they will be visited every three months to evaluate progression and     survival.   "
67200|NCT02406131|"     The investigators will established relation between restenosis and inflammatory response to     shearing stress caused by angioplasty suggest that any mechanism that affect inflammatory     response can consequently affect the restenosis rate. There is accumulated evidence that     remote ischemic precondition has modifying suppressive effect on inflammatory response and     the investigators hypothesized that RIPC may lead to reduction in post angioplasty restenosis     rate.   "
67201|NCT02406118|"     The purpose of this study is evaluation of the safety and the efficacy of transanal total     mesorectal excision.   "
67202|NCT02406105|"     Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife     based functional radiosurgery for Parkinson disease patients suffering from tremor.   "
67203|NCT02406092|"     This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC)     administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL)     (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell     lymphoma (DLBCL) (treatment plus 24 months of follow-up).   "
67204|NCT02406079|"     Procalcitonin (PCT) is a reliable biomarker of infection and sepsis. The investigators aimed     to determine whether tracheotomy influences PCT concentrations in patients without sepsis,     and to assess whether operative duration and procedure affect the peak PCT level.   "
67218|NCT02405897|"     Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves     multiple body organs. The diagnosis requires the presence of compatible clinicoradiological     features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph     nodes and the lung parenchyma are the most commonly involved structures in sarcoidosis that     can be sampled by, performing various bronchoscopic techniques. In a recent study the use of     alligator forceps had a better yield in comparison to cup forceps. The investigators     hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup     forceps will yield larger samples, thereby improving the diagnostic yield and reducing the     number of biopsy samples irrespective of the stage of sarcoidosis.   "
67205|NCT02406066|"     This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam)     in otherwise healthy adults who are regular cigarette smokers. There will be 3 groups of 8     subjects; in each group, 6 subjects will get the drug combination and 2 will get placebo.     Neither the subjects nor the study personnel will know who got drug and who got placebo     (double-blind). In the first group the drug doses will be low, and they will be increased in     the second and third groups. Subjects will receive a single dose on Day 1, followed 24 hours     later by the start of doses twice daily for 7 days, and then a final morning dose on the last     day. The levels of the drugs in the blood will be assessed by repeated blood draws after the     first day and after the end of dosing. Safety will be assessed after the single dose and     repeated dosing. Effects of study drug on smoking and craving cigarettes will be assessed at     the end of repeated dosing. The hypothesis is that this drug combination will be safe, with     relatively few side effects.   "
67206|NCT02406053|"     The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory     cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is     a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive     pulmonary disease (COPD) [3] and obstructive sleep apnea syndrome (OSAS) [4, 5]. The current     evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and     progression of respiratory diseases. The major exposures that cause OS can be summarized as     smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic     diameter of 2.5 µm [6-8]. Epidemiological and clinical studies showed that the overall     outcome of pulmonary OS is increased mortality due to increased incidence of respiratory     diseases [9].   "
67634|NCT02400437|"     This research study is evaluating a drug called ixazomib (also known as MLN9708) in     combination with dexamethasone and rituximab (the regimen is called IDR) as a possible     treatment for Waldenstrom's Macroglobulinemia (WM).   "
67207|NCT02406040|"     Weight loss through energy restriction results in the loss of both fat and muscle mass.     Muscle mass is important for mobility, strength, glucose control and energy expenditure, and     therefore the retention of muscle mass during energy restriction is an important goal. The     retention of muscle mass depends on the balance between muscle protein synthesis (MPS) and     muscle protein breakdown (MPB). It is well known that MPS is reduced during weight loss,     however the effect of weight loss on MPB is currently a topic of debate. The purpose of this     study is to assess the effect of short-term (10 day) weight loss (40% energy deficit) on both     MPS and MPB in order to gain insight into the mechanisms causing muscle loss during energy     restriction. In addition, the effect of resistance exercise and protein (both known to     preserve muscle mass) on MPS and MPB will be examined   "
67208|NCT02406027|"     The purpose of this study is to evaluate the long-term safety and tolerability of     JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease     that slowly destroys memory and thinking skills, and eventually even the ability to carry out     the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with     JNJ-54861911, who are willing to continue their assigned treatment.   "
67209|NCT02406014|"     This is a phase 4, multi-centre, randomized, two group, open label, active controlled,     parallel group, 17 week trial.   "
67210|NCT02406001|"     The purpose of this randomized trial was to compare reconstructive surgery of advanced     peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap     debridement (OFD/Control) in a non-submerged technique over 6 months.   "
67211|NCT02405988|"     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least     in Norway. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is     required. The purpose of this study is to explore the pharmacokinetics and pharmacodynamics     of naloxone in healthy volunteers under opioid influence.   "
67212|NCT02405975|"     This study will assess, by means of a randomized controlled trial, the impact of an online     educational tool, on doctors' knowledge and confidence with regards to prescribing for older     patients.   "
67213|NCT02405962|"     The purpose of this study is to examine whether a parental training program using group-based     Acceptance and Commitment Therapy for childhood asthma care, is effective in reducing the     number of children's unplanned health care services utilization and asthmatic symptoms.   "
67214|NCT02405949|"     Obesity is directly related to an increased risk of diabetes mellitus, hypertension,     dyslipidemia, cardiovascular disease, and overall mortality. Weight loss is effective in     decreasing these risks and to reduce disease severity. Bariatric surgery is an effective     therapy for sustained weight loss and type 2 diabetes (T2D) remission in most of the morbidly     obese patients. But there is also a significant number of individuals with an inappropriate     response to bariatric surgery. Two recent retrospective studies assessed the role of genetic     load as a predictor of this response, but the results are still unelucidated. The aim of this     study is to assess whether a selection of genetic variants may allow us to identify     individuals who will have a satisfactory response after bariatric surgery in terms of weight     loss and T2D remission.   "
67215|NCT02405936|"     The aim of this prospective study is to collect data on patients undergoing gynecologic     surgery at Kangbuk Samsung Hospital.   "
67216|NCT02405923|"     This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind     intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice     hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula     for the management of Cow's Milk Protein Allergy (CMPA).   "
67217|NCT02405910|"     Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in     combination with gemcitabine, at two different dose combinations as first line therapy in     patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer     (NSCLC).   "
67246|NCT02405520|"     This phase I clinical study was designed to evaluate the safety and immunogenicity of the     novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO.,     LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers     will receive the 3 different formulations of the novel HPV vaccine or placebo administered     intramuscularly according to a 0-1-6 month schedule.   "
67219|NCT02405884|"     Objective: To evaluate the variation in intraocular pressure in patients with chronic kidney     disease, according to the time interval between hemodialysis sessions and to the influence of     weight and blood pressure on intraocular pressure.      Methods: This was a cross-sectional study in which 78 eyes of 39 patients on hemodialysis, at     the Santa Casa de Misericordia de Goiânia hospital, were analyzed in June 2014. Patients were     divided into groups according to the days on which they underwent hemodialysis. The mean,     standard deviation, and median of the intraocular pressure, blood pressure, and weight were     calculated. P-values <0.05 were considered statistically significant.   "
67220|NCT02405858|"     The purpose of this study is to evaluate the percentage of participants achieving     prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to     Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.   "
67221|NCT02405845|"     Hardened plaque located in the carotid arteries can cause stroke or transient ischemic attack     (TIA). This type of plaque is linked to unstable free-floating thrombi (FFT). FFT are blood     clots that form in a blood vessel, and are at the highest risk for travelling within the     bloodstream and causing strokes. Physicians are able to see this type of plaque with computed     tomographic angiography (CTA) but FFT look very similar to stable types of plaque that do not     require urgent treatment.      Distinguishing between these plaques is important because it affects the choice and urgency     of treatment that patients receive.      The researchers have found a promising visual marker on CTA scans. The goal of this study is     to determine if this visual marker seen on CTA scans will help to distinguish FFT plaque from     stable plaque.   "
67222|NCT02405832|"     The objective of this study is to assess the effect of preoperative administration of oral     zinc lozenges on the incidence of postoperative sore throat syndrome.      When patients undergo surgery with general anesthesia, they require ventilation of their     lungs with the help of a flexible tube (called an endotracheal tube) that is placed through     the mouth, passing the vocal cords, and into the windpipe (trachea). This tube helps     oxygenate the patient, delivers anesthetic gas to the lungs, and keeps the airways open to     prevent asphyxiation. The procedure is invasive and uncomfortable, and one of the most common     consequences is a sore and inflamed throat after the tube is taken out. This is termed     postoperative sore throat (POST). Though the intensity and severity of sore throat varies     from person to person, the reported incidence is as high as 90% of patients undergoing     general anesthesia.      Zinc therapy has been shown in multiple studies to reduce the severity and duration of cold     symptoms, and also to up-regulate the immune system. Recent studies have shown that zinc can     act as an anti-inflammatory agent and can maintain the integrity of skin and mucosal     membranes (which cover the inside of the mouth and throat). The aim of this study is to     evaluate the effects of giving zinc lozenges before tube placement on postoperative sore     throat.      After written informed consent is received in pre-op, a sealed and coded envelope with either     the zinc lozenge or the placebo lozenge will be given to the patient to be administered     orally, with the instruction to dissolve the lozenge by sucking on it 30 minutes prior to     surgery. Upon completion of surgery and emergence from general anesthesia, the patient will     be extubated and transferred to the post-anesthesia care unit (PACU). Once in the PACU, the     patient will be assessed regarding the incidence and severity of POST by the study     investigator using a standardized scale. The severity of POST will be graded on a 4-point     scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only     upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being     severe sore throat (change in voice, hoarseness, and throat pain). This evaluation will be     performed at 30 minutes, 2 hours, 4 hours, and 24 hours post-surgery, with the assessment at     4 hours being the primary outcome of the study.   "
67223|NCT02405819|"     Objective: to describe and compare the implementation of two cancer survivorship care tools:     (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a     provider-initiated tool. The results of this study will be used to (1) provide an initial     assessment of the two survivorship care planning tools and (2) inform the design and conduct     of a larger study.   "
67224|NCT02405806|"     The overall aim for this study is to evaluate the clinical effects of a modified diet on     metabolic risk factors such as diabetes mellitus and obesity, and the mechanisms this     nutrition composition exerts on gastrointestinal physiology, inflammatory responses, and     quality of life, where the subjects are their own controls.      Within this study, the investigators will be able to relate the nutritional composition to     metabolic disorders, the gut microbiota, secreted intestinal neuropeptides, and bio- and     inflammatory markers in serum, plasma and urine.   "
67225|NCT02405793|"     The purpose of this study is to evaluate the safety and efficacy of a low dose and a high     dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due     to osteoarthritis of the knee or hip.   "
67226|NCT02405780|"     The purpose of the study is to compare the safety, effectiveness and immunogenicity of FKB327     in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002     and have inadequate disease control on methotrexate.   "
67227|NCT02405767|"     The BIPPED study seeks to determine whether wound healing, in particular diabetic foot     ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the     resistance of biological tissue to the passage of a very small electric current applied with     electrodes. Different types of tissue, due to cell structure, hydration and vascularization,     have specific electrical characteristics. The BIPPED study aims to provide experimental data     for the development of a BIA sensor for monitoring of wound healing in chronic wounds.   "
67228|NCT02405754|"     This is a retrospective study, designed to be conducted at a single-center in the US. The     study will conduct a one-time data abstraction from approximately 500 patient medical charts     who received Corus CAD testing, by order of the Principal Investigator. Limited demographic     data and patient data pertaining to cardiology referral or advanced diagnostic testing will     be collected. All data will be collected anonymously.   "
67229|NCT02405741|"     Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in     the tissues and has been proven to be beneficial in treating different ischemic wounds, and     acute retinal artery occlusion (ARAO) but its effect hasn't been tested in CRVO patients yet.   "
67230|NCT02405728|"     The use of peripherally inserted central catheters (PICCs) represents a major advance for     hematological patients, enabling the effective delivery of chemotherapy and/or blood products     particularly for prolonged infusions or in situation of difficult venous access. In modern     medical practice their use has increased rapidly for several reasons, including ease of     insertion, many uses (e.g., drug administration and venous access), perceived safety, and     cost-effectiveness compared with other central venous catheters (CVCs).   "
67231|NCT02405715|"     This study evaluates the addition of intranasal oxytocin to the treatment of Major Depression     using interpersonal psychotherapy. Half of the participants will receive a placebo adjunct to     interpersonal psychotherapy, and the other half will receive oxytocin.   "
67232|NCT02405702|"     The infection of a total knee replacement often imposes changing implants. The change in two     step is currently considered the gold standard. The change in one step is a much debated     attitude: strictly contra-indicated for some professionals, but others agree to reserve these     for favorable suspected cases selected. Several criteria have been proposed in the     literature: age, condition, duration of infection, known bacterium responsible, not virulent     and sensitive to antibiotics, no fistula, no significant bone destruction. But these criteria     are poorly validated, standing over an experience of surgical teams rather than high-level     scientific studies. Some authors have proposed to achieve change in one step systematically.     The results of these cohorts on healing the infection does not seem very different from the     changes in two steps. But it is most often single-center series, uncontrolled, with small     numbers.   "
67233|NCT02405689|"     The aim of this study was to investigate the myocardial protective effects of remifentanil     and dexmedetomidine in cardiac surgery.   "
67234|NCT02405676|"     The purpose of this study is to test whether adding 4 injections of rituximab and increasing     the intensity of chemotherapy regimens in advanced patients can improve the EFS compared with     the historical study CCCG-NHL-2009.   "
67235|NCT02405663|"     To compare between the effect of controlled cord traction and manual removal of the placenta     on blood loss among women undergoing caesarean sections   "
67301|NCT02404805|"     The investigator believes simeprevir concentrations are unchanged when administered in     combination with dolutegravir relative to administration alone. The investigator believes     dolutegravir concentrations are unchanged when administered in combination with simeprevir.     Additionally, the investigator believes simeprevir and dolutegravir are safe when     administered alone and in combination.   "
67236|NCT02405650|"     Obesity and chronic kidney disease (CKD) are major public health problems. In contrary to     observations in general population, higher body mass index in those with pre-existing CKD is     associated with lower mortality. Chronic Renal Insufficiency Cohort (CRIC) is an ongoing     observational study to examine the consequences of CKD with a particular focus on     cardiovascular illness like myocardial infarction (heart attack) and stroke. Among CRIC study     participants, the investigators propose to obtain visceral and subcutaneous adiposity and     physical fitness measures and study its associations with patient-centered outcomes. This     study will help the investigators understand the independent and combined effects of visceral     adiposity and physical fitness on cardiovascular disease, renal disease progression and death     among those with CKD. Further, it will identify mechanisms that could be targeted to reduce     the detrimental effects of visceral adiposity in those with kidney disease.   "
67237|NCT02405637|"     The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and     such swallowing is essential for normal small bowel development.Growth factors found in the     amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding     intolerance is a common problem among premature neonates, the investigators will study the     role of enteral administration of simulated amniotic fluid solution in prevention of feeding     intolerance and NEC in premature neonates.   "
67238|NCT02405624|"     Patients with infantile onset Pompe disease will be trained with continuous positive airway     pressure to see if hypernasality can be improved.   "
67239|NCT02405611|"     This study is a longitudinal controlled trial that is designed to investigate the     effectiveness of a multi-component intervention on improving fruit and vegetable consumption     in teenagers and their mothers.   "
67240|NCT02405598|"     evaluate if beta 2-adrenergic agonist can have adjuvant effect to patients with     infantile-onset Pompe disease under enzyme replacement therapy   "
67241|NCT02405585|"     Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most     patients diagnosed with pancreatic cancer continue to die from the rapid progression of their     disease. One primary reason for this is that the disease is typically without symptoms until     significant local and/or distant spread has occurred and is often beyond the chance for cure     at the time of the diagnosis. The lack of any treatment to substantially increase long term     survival rates is reflected by the poor outcomes associated with this disease, specifically     time to disease progression and overall survival.      However, another important part of the body is now being looked at as a target for therapy     against this disease - the immune system. Scientists have clearly shown that pancreatic tumor     cells produce a number of defective proteins, or express normal proteins in highly     uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause     an immune response to the cancer cells much in the way one responds to infected tissue. In     progressive cancers however, the immune system fails to effectively identify or respond to     these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet     fully understood. This clinical trial proposes a new way to stimulate the immune system to     recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks     the growth of the cancer.      This new method of treatment helps the immune system of pancreatic cancer patients to     identify the cancerous tissue so that it can be eliminated from the body. As an example,     patients with certain diseases may require an organ transplant to replace a damaged kidney or     heart. After receiving their transplant, these patients receive special drugs because they     are at great danger of having an immune response that destroys or rejects the transplanted     organ. This rejection occurs when their immune system responds to differences between the     cells of the transplanted organ and their own immune system by attacking the foreign tissue     in the same way as it would attack infected tissue. When the differences between foreign     tissues and the patient's body are even larger, as with the differences between organs from     different species, the rejection is very rapid, highly destructive, and the immunity it     generates is longlasting. This is called hyperacute rejection and the medicine used to     immunize patients in this protocol tries to harness this response to teach a patient's immune     system to fight their pancreatic cancer just as the body would learn to reject a transplanted     organ from an animal.      To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that contain     a mouse gene that marks the cancer cells as foreign to patient's immune systems. The immune     system therefore attacks these cancer cells just as they would attack any truly foreign     tissue, destroying as much as it can. Additionally, the immune system is stimulated to     identify differences (aside from the mouse gene) between these cancer cells and normal human     tissue as foreign. This education of the immune system helps treat the patient because     pancreatic cancer cells already present in a treated patient are believed to show some of the     same differences from normal tissue as the modified pancreatic cancer cells in the product.     Due to these similarities, the immune system, once educated by the Algenpantucel-L     immunotherapy, identifies the patient's cancer as foreign and attacks.      Historically, external beam radiation has been part of the treatment of pancreatic cancer,     both before and after surgical resection. Recent breakthroughs in technology now allow for     more intensive doses of radiation to be delivered to the body with greater precision. These     newer, more precise radiation treatments, called stereotactic body radiation, deliver more     intensive radiation to a locally advanced tumor and are now being employed in the treatment     of pancreatic cancer. Stereotactic body radiation may increase the chances that surgery will     successfully remove a pancreatic cancer.      In this experimental study, all patients will be given a strong combination of antitumor     chemotherapy while receiving injections of an immunotherapy drug consisting of two types of     pancreatic cancer cells that have been modified to make them more easily recognized and     attacked by the immune system. The investigators propose to test this new treatment paradigm     along with stereotactic body radiation in patients with borderline resectable pancreatic     cancer to demonstrate that treatment with this combination of therapies increases the time     until the tumor progresses as well as overall survival.   "
67242|NCT02405572|"     Crossover study of 2 infant formulas   "
67243|NCT02405559|"     The lymphatic system is one of the keystones of fluid homeostasis in the interstitium. In     analogy with the arterial systolic pressure, the lymphatic pressure can give us information     about the functioning of the cardiovascular system and fluid exchange. Actually, knowledge     about this physiological parameter is incomplete because of the lack of technology. Former     measurement techniques of the lymphatic pressure in the living healthy man were invasive and     too complex to be interpreted.      The lymphatic occlusion pressure has to be clarified because lymphedema treatment, concerning     the pressure to be applied on the edematous tissue is still based on controversial concepts.      On one hand, techniques such as Manual Lymphatic Drainage, sustain the necessity to apply a     very low pressure in order to avoid the squeezing of superficial lymph vessels. On the other     hand sustainers of Intermittent Compression Therapy advocate the necessity to apply     relatively high pressure to obtain a decongesting effect. These completely opposite opinions     triggered us to study lymphatic pressure more thoroughly.      Lymphofluoroscopy (emerging imaging technique in the field of lymphology) is now used since 3     years by the promoters of this study to visualize the architecture of the superficial     lymphatic network and the progression of the lymph inside the highlighted vessels. This     technique will be used in the present (prospective and multicentric) study to observe the     effect of a pressure applied on the lower limb on the displacement of the lymph, and then to     determine the occlusion pressure of the lymphatic vessels. The investigators already studied     the occlusion pressure of the superficial lymphatic vessels of the upper limb in a previous     study. The investigators would like to complete our results with the lower limb.   "
67244|NCT02405546|"     A nasal endotracheal tube (ETT) is routinely placed in children and a fiberoptic scope (FOS)     is commonly used for this purpose. Resistance to the passage of ETT is frequently encountered     as it is advanced over the FOS for placement into the trachea, since it gets hung up on     structures of the laryngeal inlet. The aim of the investigators study performed on forty     children divided in two groups was to study in the pediatric population, whether a 90°     counterclockwise rotation (CCR) of the ETT prior to advancing through the larynx, by nasal     approach, prevents it from getting hung up at the laryngeal inlet.   "
67245|NCT02405533|"     This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary     outcome of this trial is achieving durable eradication persistent high risk HPV infection     determined by HPV negative test results achieved while on active treatment with AHCC and     maintained for 6 month post supplementation and 12 months post completion of AHCC treatment     compared to placebo.   "
67247|NCT02405507|"     Wheat germ is a by-product of the wheat-milling industry with high nutritional value and     therefore could be used as a raw source for the preparation of food products such as bread,     cookies, muffins, etc.      The aim of this study is to assess the effects of ingesting wheat breads supplemented with     wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic     response in healthy human volunteers.   "
67248|NCT02405494|"     Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective of     this study is to test the individual contribution, and possible interaction, of the liquid     volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x [gas     volume/liquid volume]) of a beverage to its satiating properties.   "
67249|NCT02405481|"     The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado;     Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to     reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by     community agency personnel. The study recruits Hispanic women between the ages of 18 and 50     who are sexually active and are randomized to either SEPA or a Wait-List Control condition.   "
67250|NCT02405468|"     The investigators want to compare blood microbiota profile between patients with documented     coronary lesions and patients free of coronary disease.   "
67251|NCT02405455|"     Cervical incompetence is a relatively complex disorder from the diagnostic and therapeutic     point of view. Despite established diagnostic criteria, it is not easy for the specialist in     clinical practice to establish limits in complicated cases. Cervical cerclage is the     technique classically used to avoid pregnancy loss or preterm birth in patients with cervical     incompetence. Although numerous studies support its efficacy, it remains a controversial     method, given what the technique implies for the clinician and patient. Difficulties and     potential risks of its insertion and inconveniences and side effects for the patient still     exist. The recently published promising results of the use of the pessary to prevent preterm     birth in women with a short cervix offer new prospectives for the management of prematurity     prevention. The short learning curve, good cost-effectiveness and, most importantly, low side     effects, render the pessary a tool of great potential.   "
67252|NCT02405442|"     This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active     Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by     an Open Label Extension. Participants who complete the Blinded Treatment Period will be     eligible to enroll in the optional Open Label Extension for an additional 44 weeks.     Participants who complete Week 52 assessments will be eligible to enter the Extended     Treatment Phase to continue treatment with GS-5745 for an additional 156 weeks.   "
67253|NCT02405429|"     The aim of this study was to evaluate the temporal artery thermometer by comparing temporal     artery and axillary thermometer temperature measurements with rectal thermometer temperature     measurements in neonatal patients. The investigators measured temporal artery, axillary, and     rectal temperatures of 49 infants. Temporal artery temperature was measured using an infrared     temporal artery thermometer, and the results with this device were compared with axillary     temperature (clinical standard) and rectal temperature (gold standard). The difference     between rectal and temporal artery temperatures was compared with the difference between     rectal and axillary temperatures for each infant, and the data were analyzed based on weight,     postmenstrual age and bed type - open crib or incubator.   "
67254|NCT02405416|"     This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with     selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in     complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another     equivalent group patients will be operated using SHVE and PTC.   "
67255|NCT02405403|"     Neuroinflammation, characterized in particular by microglia activation, is an essential     component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO) is     recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease     activity. An experimental radiopharmaceutical specific of TSPO expression, namely     [18F]DPA714, allow to quantify this microglial activation using Positon Emission Tomography     (PET) imaging.      The purpose of this study is to longitudinally correlate the spatial distribution of     neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in     ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary     approaches in 20 ALS patients:        -  in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines          secreted by microglial cells in the cerebrospinal fluid (CSF).        -  in vivo: [18F]DPA714 PET imaging. These assays will be performed in the framework of the          clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months latter.   "
67256|NCT02405390|"     The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will     result in less head motion and therefore less cervical motion when compared with direct     laryngoscopy (DL).      The aim of the study is to determine the amount of head motion (extension, flexion and     rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily,     the study will also measure the number of attempts to properly intubate and the time required     for intubation with either technique.   "
67257|NCT02405377|"     Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive     sufficient hydration before application of contrast to prevent CIN, but hydration could     obviously increase the preload for congestive heart failure (CHF) patients. It is important     to make an individual hydration protocol for patients with dysfunction of heart and renal to     reduce the incidence rate of CIN. This prospective, randomized, double-blind, comparative     clinical trial randomly selected 264 patients with estimated glomerular filtration rate,     (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary angiography to receive either the     convention hydration (n=132) or the central venous pressure (CVP) guided hydration (n=132).   "
67258|NCT02405364|"     The purpose is to determine whether induction and consolidation treatment with Carfilzomib,     Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further     investigation in clinical trials.   "
67399|NCT02403531|"     The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown.     The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy     followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with     inoperable thoracic esophageal squamous cell carcinoma.   "
67259|NCT02405351|"     The investigators propose to develop a Telerehabilitation approach to working memory training     for patients experiencing working memory deficits post stroke. The investigators have     currently developed a game-like computerized working memory training program that can be     accessed via the internet for research purposes. The investigators propose to refine the     website to focus more on clinically based training, and to evaluate the feasibility and     initial effectiveness of this approach in a pilot study with participants after stroke.   "
67260|NCT02405338|"     This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20     patients including a safety-run in phase I part comprising 6 patients.      Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs),     presenting two leukemia-associated antigens.   "
67261|NCT02405325|"     Older adults are the least active population group in the US. Yet, research has shown that an     increase in physical activity (PA) can have immediate and profound effects on cardiovascular     health. Older adults who are active use significantly fewer health care resources, and with     the increasing number of older adults in the US it is imperative to curb health care     expenditure in this group. PEP4PA (Peer Empowerment Program 4 Physical Activity) is a     multilevel intervention aimed at increasing physical activity levels in a population of low     income and ethnically diverse older adults. It will be delivered in centers by trained older     adults. Participants will work towards a daily increase of 2000 steps per day through     self-paced incidental walking, peer led group walks, and attendance at existing center PA     classes. They will also work on projects to increase opportunities to be physically active at     their center or in the surrounding neighborhood.   "
67262|NCT02405312|"     This year, 90,000 Americans with end-stage renal disease (ESRD) will die and questions will     legitimately be raised as to whether terminal treatment and location of death adequately     represented their preferences. These concerns are linked by a failure on the part of patients     and staff to discuss prognosis and share in end-of-life (EOL) planning. The rate of hospice     use among patients dying with ESRD is half that of the national average and one-quarter the     rate for patients with terminal cancer. In other patient populations when meaningful EOL     conversation occurs this is associated with increased hospice referral and improved quality     of the dying.      Patients receiving hemodialysis (HD) often desire but rarely communicate with staff about     prognoses, know little about availability of community hospice resources, or how to complete     advance directives. Nephrologists are not trained to have these conversations, and although     accustomed to relying on interdisciplinary teams, they are unaccustomed to collaborating with     community hospices. Our preliminary research began by using focus groups, created and     validated the first clinically useful HD prognostic tool, and developed a prototype for     Shared Decision Making and Renal Supportive Care (SDM-RSC). This is a novel multimodal     intervention that familiarizes patients, families, and dialysis staff with community hospice     resources, emphasizes dialysis social work support, conveys information about terminal care     issues, and encourages advance care planning.      The proposed study tests the central hypothesis that EOL care can be improved by relying on     patients and stakeholders to enhance SDM-RSC for HD patients who are most likely to die. It     will test whether an intervention that targets communication deficiencies can alter EOL     outcomes and achieve the goal of matching patient preferences with terminal treatments.   "
67263|NCT02405299|"     This research aims to assess the cognitives rehabilitations in attention deficit disorder     (ADHD) in children. the objective is to demonstrate what are the most relevant cognitive     factors for rehabilitative to improve the inhibition of disorders in ADHD.   "
67264|NCT02405286|"     This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding     and death in patients with upper gastrointestinal bleeding.   "
67265|NCT02405273|"     Lung cancer is the leading cause of cancer death in males, and is increasing in females. Up     to 73% of affected patients present with Chronic Obstructive Pulmonary Disease (COPD). Most     lung cancer patients have an average survival of about 8 months from diagnosis. Lobectomy for     initial stages has demonstrated higher survival rates, but only 15% to 25% are surgical     candidates; unfortunately, cardiopulmonary impairment mainly due to coexisting COPD reduces     this number and patients undergo medical treatment or marginal lung resection, with minor     functional impact but possible ineffective control of disease.      Furthermore, COPD is associated with increased postoperative morbidity and mortality, longer     in-hospital stay, need for additional treatments, and a rise in sanitary costs.      The investigators planned a randomised trial on surgical candidates to assess the effect of     comprehensive pulmonary rehabilitation on functional and surgical outcomes, functioning, and     Quality of Life (QoL).   "
67266|NCT02405260|"     This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active-     controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of     TTP399 on HbA1c following administration for 6 months.   "
67267|NCT02405247|"     The aim of this study is to evaluate clinical outcomes of 2nd line therapy in NSCLC patients     without the T790M mutation, both independently and when compared indirectly with NSCLC     patients with the T790M mutation in the T STAR non interventional study (D5160R00001).      The patient population in the TAURAS study will consist of patients who fail screening for     AURA3 (D5160C00003) due to a T790M mutation not detected using the central cobas® EGFR     Mutation Test (Roche Molecular Systems).   "
67268|NCT02405234|"     The proportion of patient successes with the Carbon Modular Radial Head at the 2-year     evaluation is no lower than the proportion of patient successes with the Metal Radial Head.   "
67269|NCT02405221|"     This study will be looking at what dose of the TA-CIN/GPI-0100 vaccine is safe and effective     in patients with a history of HPV16 associated cervical cancer.   "
67270|NCT02405208|"     This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective     clinical outcomes investigation to evaluate the short, mid and long term performance of the     PyroTITAN™ HRA Shoulder prosthesis humeral replacement.   "
67271|NCT02405195|"     Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary     bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion,     filtration and oxygenation.   "
67342|NCT02404272|"     Poor oral motor development in preterm neonates is common. Feeding problems lead to longer     hospital stay and higher hospital cost. Different interventions have shown their efficacy to     accelerate transition and move faster to full oral feeding autonomy. Our study aimed to     evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay     of preterm neonates.      This is an interrupted time series study placed in Intensive Care and Neonatal unit of an     university hospital located in Lyon, France. All preterm neonates are included in the study,     from April 2013 to January 2016.   "
67343|NCT02404259|"     This study will assess the pharmacokinetics of TDF in Thai HIV-infected children   "
67272|NCT02405182|"     Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative     disorder. There is no treatment that significantly slows progression. Increasing age is an     important risk factor for developing ALS; thus, the societal impact of this devastating     disease will become more profound as the population ages. A significant hurdle to finding     effective treatment has been an inability to accurately measure brain degeneration in humans.     Advanced magnetic resonance imaging (MRI) techniques hold promise in this respect, and may     assist in aiding diagnosis and the efficient testing of new drugs.      Different MRI features of brain degeneration will be measured in a large sample of patients     with ALS. The study will operate within the Canadian ALS Neuroimaging Consortium (CALSNIC).     CALSNIC is a clinical research platform comprised of ALS clinics with standardized clinical     and neuroimaging protocols.   "
67273|NCT02405169|"     The primary objective of the present study is to evaluate the marginal bone level changes     occurring in total edentulous patients treated with six or four implants.      Secondary objective        -  overall survival rate        -  soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth          (PPD) at baseline and after 1,3,5 years        -  prosthetic survival rates including screw or abutment loosening, framework or veneer          fractures   "
67274|NCT02405156|"     To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical     termination of pregnancy in second trimester abortion.   "
67275|NCT02405143|"     Occipital stroke is associated with homonymous visual field defects (occurring on one side of     the visual field). Despite spontaneous recovery, some degree of defect is often permanent.     Currently, no treatment exists for such visual field defects.The purpose of this study is to     test the efficacy of a type of electrical brain stimulation method, transcranial alternating     current stimulation, in reducing these type of visual field defects in their chronic stage.   "
67288|NCT02404974|"     The purpose of this pilot study is to assess the feasibility, acceptability, and potential     effectiveness of identifying people with osteoarthritis (OA) who are interested in     individualized exercise programs through a web-based osteoarthritis application; assessing     their exercise barriers, facilitators, motivators and preferences; and engaging them in an     exercise program tailored to meet their needs by a Certified Fitness Trainer.   "
67276|NCT02405130|"     Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for     treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to     restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as     early as possible. No-reflow is the term used to describe inadequate myocardial perfusion of     a given coronary segment without angiographic evidence of persistent mechanical obstruction     of epicardial vessels and it refers to the high resistance of microvascular blood flow     encountered during opening of the infarct-related coronary artery.      Despite optimal evidence-based PPCI, myocardial no-reflow can still occur, negating many of     the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital     and long-term prognosis. Several strategies have been tested to revert the no-reflow     including the use of thrombectomy, glycoprotein IIb/IIIa inhibitors and the use of     intracoronary adenosine, but none has been demonstrated to effectively counteract the     phenomenon.      The trial aims to show the effect of the administration of intracoronary adrenalin on     myocardial reperfusion assessed by magnetic resonance in patients with STEMI undergoing PCI     and with persistent coronary angiographic The Thrombolysis in Myocardial Infarction (TIMI)     0-1 flow during the interventional procedure after failure of standard therapy.   "
67277|NCT02405117|"     This study will develop and pilot a smartphone intervention, LiveWell, to enhance patient     self-management of bipolar disorder and facilitate more efficient, timely care delivery by     mental health providers. The intervention uses a mobile application to collect daily     self-report and continuous behavioral data and adapts intervention content to create a highly     tailored and user-responsive treatment system. Patient data collected by the phone will also     be provided to clinicians to allow for better evaluation and targeting of treatment. The goal     is to reduce symptoms and prevent relapse in patients with bipolar disorder.   "
67278|NCT02405104|"     The purpose of this study is to elucidate whether patients operated with THA and TKA can     benefit from treatment with chlorzoxazone.   "
67279|NCT02405091|"     Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered     once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately     150 medically stable male and female subjects with clinical diagnoses of schizophrenia or     schizoaffective disorder with neuroleptic-induced TD or mood disorder with     neuroleptic-induced TD.   "
67280|NCT02405078|"     The goal of this clinical research study is to learn if performing blood tests and imaging     scans at different time points during chemotherapy can help researchers predict if patients     with DLBCL will respond to treatment.   "
67281|NCT02405065|"     The main objective of this study is to determine the maximum tolerated dose (MTD) and     recommended phase 2 dose of HM95573.   "
67282|NCT02405052|"     Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable     condition, is the most prevalent condition associated with unexplained chest pain in the     emergency department. Panic-like anxiety may be responsible for a significant portion of the     negative consequences of unexplained chest pain, such as functional limitations and     chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the time     of discharge from the emergency department. The 4-item Panic Screening Score questionnaire     was derived in order to increase the identification of panic-like anxiety in emergency     department patients with unexplained chest pain.      The goals of this prospective cohort study are to (1) refine the Panic Screening Score; (2)     validate the revised version of the Panic Screening Score; (3) measure the reliability of the     revised version of the Panic Screening Score and (4) assess the acceptability of the     instrument among emergency physicians.   "
67283|NCT02405039|"     This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL     topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a     one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be     enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and     Canada.   "
67284|NCT02405026|"     The purpose of this study is to determine the prevalence and severity of asthma in patients     with HIV. To determine the immunological phenotype of HIV-infected patients with asthma.   "
67285|NCT02405013|"     Primary Objective:      To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment     [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and     weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in     treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa      Secondary Objectives:        1. To estimate the study treatment SVR24 rate        2. To evaluate the clinical and biological tolerance of study treatment        3. To describe HCV kinetics under HCV treatment, and identify associated factors        4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected          patients        5. To describe the changes of liver fibrosis based on non-invasive tests between treatment          initiation, week 24, and week 36 after treatment, and estimate its association with          SVR12 or SVR24        6. To identify factors associated with SVR12 and SVR24 (including HIV status)        7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and          genotypying and for assessing response to treatment (SVR12 and SVR24)        8. Facilitate the detection and treatment of those infected with HCV by supporting national          initiatives for access to strategies without interferon        9. To set up a HCV clinical research network across French and English-speaking African          countries, able to run large-scale comparative randomized clinical trials in a near          future.   "
67286|NCT02405000|"     The objective of this research is to perform a pilot study on patients undergoing     laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer)     in which intraoperative CT imaging will be performed both prior to (but after induction of     general endotracheal anesthesia) and during placement of the laryngoscope in order to better     understand anatomic changes that occur during instrumentation of the oral cavity and     oropharynx. The goals of the study are:        1. Develop a suite of de-identified images and surface renderings that qualitatively show          how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic          evaluation.        2. Create deformation models of the upper aerodigestive tract.      This data to be used for future retractor development as well as for virtual image guided     surgery.   "
67289|NCT02404961|"     The investigators plan to study the etiology of vulvodynia, a condition characterized by     chronic vulvar discomfort, most often described as burning pain, occurring in the absence of     relevant visible findings or a specific, clinically identifiable, neurologic disorder. Our     hypothesis is that vulvodynia is the result of an altered immuno-inflammatory response     mechanism that occurs as a consequence of reproductive, gynecologic, environmental, or     psychological exposures, with abnormal vaginal microflora and genetic polymorphisms as     potential modifiers of the effects of interest. Therefore, the investigators propose to     collect information about reproductive, gynecological and environmental exposures,     psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation     and nerve fiber proliferation.   "
67290|NCT02404948|"     This is a validation study comparing a pulse wave based algorithm for the detection of     coronary artery disease with parameters from coronary angiography, echocardiography and     cardiogoniometry.   "
67291|NCT02404935|"     National multicentric phase II trial evaluating whether single agent cetuximab is effective     as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients     with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after     start of maintenance therapy.   "
67292|NCT02404922|"     This study will assess in healthy male and female subjects the safety, tolerability and     pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days     of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.   "
67293|NCT02404909|"     The aim of this study was to evaluate whether IVC index measured intraoperatively was     affected by fluid administration and could add any helpful information about the hemodynamics     during hepatic resection. In addition, the investigators evaluated whether IVC index was     somehow correlated with the risk of postoperative complication.   "
67294|NCT02404896|"     Metreleptin was approved in the United States as adjunct to diet as replacement therapy to     treat the complications of leptin deficiency in patients with congenital or acquired     generalized lipodystrophy in February 2014. The approval was based on results obtained in 2     open-label, investigator-sponsored studies (Studies 991265 and 20010769) conducted at the     National Institutes of Health (NIH) to evaluate the safety and efficacy of metreleptin     treatment in patients with lipodystrophy and 1 treatment IND (FHA101/MB002-002/MB002-002)     conducted by Bristol-Myers Squibb on behalf of AstraZeneca (BMS/AZ) in patients with diabetes     mellitus and/or hypertriglyceridemia related to lipodystrophy. These studies enrolled     patients with lipodsytrophy including both generalized and partial lipodystrophy. Although     the marketing authorization restricted the indication to patients with generalized     lipodystrophy, meaningful clinical benefit was achieved in a subset of patients with partial     lipodystrophy, and these patients from FHA101/MB002-002 form the basis of the request for     ongoing treatment under expanded access.   "
67295|NCT02404883|"     Women who are diagnosed with cancer during their reproductive lifespan might be confronted     with impaired fertility. Nowadays a number of fertility preservation options are available.     Decisions about whether and how to protect fertility have to be made in a very short time     period, right after cancer diagnosis and before start of treatment. The psychological impact     for patients is considerable. This project aims at developing a standardized decision-aid     tool to support the decision-making process about fertility preservation in young cancer     patients. It is designed as an online decision-aid tool. A web-based tool is perfectly     designed for this target group and offers new possibilities providing flexible and     individually tailored information.      The aim of the study is to examine the benefits of the online decision-aid tool compared with     standard counseling (usual care). Decisional conflict is measured immediately after     counseling as well as one month later. One year after counseling, decisional regret is being     evaluated additionally. If the decision-aid tool proves to be helpful and useful, the online     design allows making it available for a wide range of concerned patients.   "
67344|NCT02404246|"     This pilot effectiveness trial will evaluate the feasibility, acceptability, and     effectiveness of a structured peer support program based on the Certified Peer Specialist     Program of the Depression and Bipolar Support Alliance (DBSA).   "
67296|NCT02404870|"     Background:      - Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase     the bone fracture risk in people with diabetes.      Objective:      - To see if Invokana has negative side effects on bone health.      Eligibility:      - Healthy men ages 18 45.      Design:        -  Participants will be screened with a medical history, physical exam, and blood tests. A          nutritionist will discuss their dietary history and the study dietary requirements.          Participants will get a food diary to record what they eat and drink on 3 separate days.        -  Participants will have a DEXA scan x-ray test of bone health. Participants will lie          still on a table while a small camera passes over the body.        -  Participants will have 2 stays in the clinic. They will be 1 week apart and each last 6          overnights starting on a Sunday.        -  Before each stay, participants will:        -  Pick up food each day for 7 days. They will get breakfast, lunch, dinner, and snacks.          They must eat only the food provided during these times.        -  Collect their urine twice.        -  During the stays, participants will:        -  Be evaluated by a doctor and have blood drawn.        -  On each Monday, participants will:        -  Skip breakfast        -  At about 8 a.m. take a placebo pill in one stay, the study drug in the other stay.        -  Drink 6 ounces of water every 2 hours for 4 hours.        -  An intravenous (IV) catheter will be inserted into an arm. Blood will be drawn every 2          hours from 8 a.m. until noon.        -  Get lunch.        -  Have blood testing again at 8pm and midnight.        -  Repeat the testing days 2 5.        -  Have urine collected.   "
67297|NCT02404857|"     The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected     to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.   "
67298|NCT02404844|"     This is a clinical trial with a molecularly stratified parallel cohort, single arm design to     explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with     ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and     different biomarker profiles, two of them potentially indicative of constitutive PI3K pathway     activation.   "
67299|NCT02404831|"     The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation     programme with traditional hospital-based pulmonary rehabilitation classes for people     affected by COPD.   "
67300|NCT02404818|"     The purpose of this study is to evaluate if radiation and chemotherapy treatment cause     cardiac abnormalities among survivors of Hodgkin's lymphoma.   "
67303|NCT02404779|"     Severely brain injured patients are at high risk of intracranial hypertension. Among medical     treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but     not english speaking societies.      Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA     versus placebo in the treatment of intracranial hypertension, and the underlying     physiopathologic effects.   "
67304|NCT02404766|"     C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to     cervical pain and headache. However, serious neurovascular adverse effects have been     documented through direct treatment of C1-C2 segment. Although indirect treatment via     adjacent segments and avoidance of end range of rotation and extension have been recommended     for a safer and effective cervical treatment, there is no scientific evidence of the     effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2     hypomobility.      Due to that, the investigators designed a randomized controlled trial to compare the     short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of     C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2     hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the     neutral cervical position can recover the C1-C2 rotational range of movement in subjects with     upper cervical hypomobility.   "
67305|NCT02404753|"     The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2     gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to     determine whether LDG can be a test arm for a future Phase III trial to evaluate the     non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant     chemotherapy.   "
67306|NCT02404740|"     Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure     (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus     are typically treated with a shunt in order to reduce ICP. At times the shunt can     malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's     shunt has malfunctioned.   "
67307|NCT02404727|"     The aim of this project is to investigate prosthesis fixation in the bone, respectively     cemented and uncemented operation method of Avantage® dual-mobility acetabular cup in elderly     patients, wear of the plastic in dual-mobility hip prosthesis and evaluate the clinical     function, patient satisfaction and possible complications.      Patients included in this study suffer from osteoarthritis of the hip.   "
67308|NCT02404714|"     This is an observational comparative study to compare the standard-of-care methods for sweat     testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing     called the CF Quantum Sweat Test System. The results of the new device in this study are for     comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.   "
67309|NCT02404701|"     The purpose of this study is to ascertain whether certain supplements promote excessive     urinary oxalate excretion and increase the risk for calcium oxalate kidney stones.     Supplements that enhance urinary oxalate excretion, as a result of their oxalate     concentration or from some other mechanism (e.g., providing substrate for oxalate     biosynthesis) will be identified by the investigators.   "
67310|NCT02404688|"     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids     on simulated driving and related cognition.   "
67311|NCT02404675|"     This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in     treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.   "
67346|NCT02404220|"     This study will evaluate the safety, efficacy, tolerability, and pharmacokinetics of     entospletinib (GS-9973) in combination with vincristine (VCR), and dexamethasone in adults     with previously treated relapsed or refractory B-cell lineage acute lymphoid leukemia (ALL).      This study consists of two parts: Dose Escalation and Dose Expansion. After 2 induction     cycles during either parts of the study, participants may be put on maintenance for up to 36     cycles if they have obtained clinical benefit from the treatment.   "
67312|NCT02404662|"     Most patients who present with problem drinking also present with mood problems. Problem     drinking and mood problems co-occurring together in individuals lead them to have more severe     symptoms, greater disability and poorer quality of life than individuals with only problem     drinking, and they pose a greater economic burden to society due to their higher use of     health services. This study aims to assess the efficacy of a new, innovative and cost     effective treatment strategy aimed at reducing the burden that these co-occurring conditions     impose on the suffers and their families as well as the community and health systems.      In a recent pilot study of supportive text messages for patients with problem drinking and     co-occurring depression, the investigators established that patients who received twice daily     supportive text messages for three months had significantly less depressive symptoms than     those who did not receive such messages. There was also a trend to finding that patients who     received the supportive text messages were more likely to have higher alcohol free days than     those who did not receive any supportive text messages.      This study seeks to extend the knowledge gained from the pilot study. A larger group of     patients with alcohol use disorder and a depressive disorder will be randomly assigned to two     groups. One group will receive supportive text messages for six months duration whilst the     other group will receive no supportive text messages. The patients will be followed up at 3,     6, 9 and 12 months to determine which of the two groups have less alcohol and mood problems.     It is anticipated that patients receiving supportive text messages will report significantly     greater alcohol free days as well as significantly less relapses, hospitalizations and mood     symptoms than those not receiving such messages.   "
67313|NCT02404649|"     This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants     (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will     enroll 30 active subjects who will receive two dental implants in the edentulous maxillary     molar region. This 24-month research study will examine the clinical stability of TMDI in     both sinus elevation and sinus augmentation environments. The proposed research lays the     foundation for improved health care by providing surgeons and restorative dentists with data     for determining the effects TMDI have on clinical success in less than optimal osseous     environments. The rationale that underlies the investigation is that identification of the     influences of trabecular surface design on implant stability in varying bone types will allow     routine, predictable use of early loading, which, in turn, will translate into more rapid,     economical health care, and improved psychosocial well-being of the patient. If these     hypotheses are correct, the results are expected to provide evidence based research data to     support early loading and immediate loading of single implants in sites of adequate bone     volume, and density with or without the use of graft materials in sinus lift procedures. In     addition, it is expected that these results will fundamentally advance the field of implant     dentistry and bioengineering by providing information on the principles of the bone     density-mechanical environment-implant stability interaction.   "
67314|NCT02404636|"     ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview     is used to quantitatively estimate:        1. Alcohol use        2. Dietary intake        3. Drug use (legal and illegal)      in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are     followed up for 12 months with regard to response to therapy and survival.      The study is intended to explore potential precipitants of alcoholic hepatitis.   "
67315|NCT02404623|"     This trial objective is to assess whether doubling the daily intake of vitamin D improves     serum vitamin D levels and serves as primary prevention of respiratory infections and asthma     in premature infants.      This is a prospective randomized (1:1) double-blinded trial.      The study population will be randomized into two groups (1:1):        -  Intervention Group - 800 IU of Vitamin D once daily        -  Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year          after randomization for serum Vitamin D levels and respiratory morbidity.   "
67316|NCT02404610|"     This study is a clinical trial of moderate sedation versus deep sedation with propofol for     procedural sedation in the Emergency Department. The purpose of this study is to compare the     rate of amnesia and respiratory depression rate in patients who receive moderate sedation to     those that receive deep sedation.   "
67317|NCT02404597|"     The purpose of this study is to describe the use of non-invasive cardiac output monitors     (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.   "
67318|NCT02404584|"     The primary objective of this study is to determine the percentage of patients with a plasma     concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml     (effective concentration according to the current literature).   "
67319|NCT02404571|"     This study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and     cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline     treatment.   "
67320|NCT02404558|"     Primary Objective:      To describe the safety and tolerability, including laboratory abnormalities following a     single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in     Japanese patients with rheumatoid arthritis (RA).      Secondary Objectives:      To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts,     total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL]     cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or     tocilizumab administered SC as monotherapy in Japanese patients with RA.      To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.   "
67321|NCT02404545|"     Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence     of parastomal hernia and associated complications.   "
67322|NCT02404532|"     The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System     by completing a series of Patch applications and IEM ingestions in the clinic.   "
67347|NCT02404207|"     The study will determine the effects of different types of soybean oils on biomarkers of risk     for cardiovascular disease and diabetes. There will be four 4-week diet periods in which     participants will consume the following oils, within the context of a controlled diet:     soybean oil, high-oleic soybean oil, blend of high oleic soybean oil & fully hydrogenated     soybean oil, and blend of palm olein & palm stearin.   "
67323|NCT02404519|"     Vitamin K is required for the activation of the inhibitor of vascular calcification: Matrix     Gla Protein (MGP). In an earlier study the beneficial effect of menaquinone-7 (MK-7), a     vitamin K2 form, was observed on the stiffness of the vessel wall in postmenopausal women. It     decreased the circulating form of inactive MGP and improved the vascular elasticity (local)     and aortic pulse wave velocity (regional). The decrease of circulating inactive MGP was     observed after 2-3 months MK-7 supplementation and the effect of MK-7 on the clinical     endpoints was observed within 3 years of supplementation. It is demonstrated in several     studies that cardiovascular risk increases with decreasing vitamin K intake and increasing     levels of inactive MGP. In this study the investigators select subjects in the highest     tertile of circulating inactive MGP. This study group will consist of subjects with increased     cardiovascular risk and it is expected that effects of MK-7 on clinical endpoints in this     group will be measurable within 1 year of supplementation.   "
67324|NCT02404506|"     Breast cancer is the most frequent malignancy in women, world-wide the leading cause of     cancer mortality. One of the strongest risk factors for developing breast cancer is age, with     a prevalence approaching 7% in women >70 years; more than 40% of breast cancer patients are     older than 65 years. Although the survival rate has increased in the last years, about one     third of patients will relapse with distant metastases. Treatment for patients with     metastatic breast cancer is palliative, therefore maintaining or improving quality of life.      The use of taxanes and anthracyclines as first line chemotherapy regimen for metastatic     breast cancer is widely accepted. Both taxanes and anthracyclines have considerable side     effects, especially in elderly patients.      Eribulin, a synthetic analogue of a chemotherapeutically active compound derived from the sea     sponge Halichondria okadai, acts as an inhibitor of microtubule dynamics. It is registered as     palliative chemotherapy in advanced breast cancer after anthracyclines and taxanes. Studies     with eribulin treatment have shown similar efficacy compared to anthracyclines and taxanes,     but less toxicity. Those studies showed that often the dose of eribulin had to be reduced     during treatment due to toxicity without compromising the efficacy of the treatment.      The main objective of the trial is to explore the efficacy of a reduced starting dose of     eribulin as first-line treatment in elderly metastatic breast cancer patients. The secondary     objective of the trial is to investigate the safety of eribulin in those patients.      Eribulin mesilate 1.1mg/m2 i.v. will be administered intravenously every 3 weeks on day 1 and     day 8 until progressive disease.   "
67325|NCT02404493|"     The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC)     skin balm in infants and toddlers with mild to moderate dry, itchy skin.   "
67326|NCT02404480|"     This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in     patients with advanced cancer.   "
67327|NCT02404467|"     The hypothesis behind this study is that there is a proportion of patients considered high or     intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged     early after the procedure (within the first 2-3 days) without additional risks. Therefore,     when performed in safety, an early discharge may cut periprocedural TAVI costs significantly.   "
67359|NCT02404051|"     This is a multi-center, randomized, open-label, parallel group study designed to evaluate     efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus     versus examestane and everolimus followed, at progression, by fulvestrant in postmenopausal     women with HR+ and HER2- LABC or MBC whose disease has progressed to NSAI in the adjuvant or     metastatic setting.   "
67328|NCT02404454|"     The septate uterus is the most common structural uterine anomaly. It results from failure of     the partition between the two fused Müllerian ducts to resorb;it is associated with the     highest incidence of reproductive failure and with first- and second-trimester pregnancy loss     and infertility.      Hysteroscopic division of the uterine septum is performed using microscissors,     electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome     after hysteroscopic metroplasty.      Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of     autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine     adhesions, through second look office hysteroscopy after three months.   "
67329|NCT02404441|"     The purpose of this first-in-human study of PDR001 is to characterize the safety,     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001     administered i.v. as a single agent to adult patients with solid tumors.      By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits     the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by     activating effector T-cells and inhibiting regulatory T-cells.      This study has been designed as a phase I/II, multi-center, open-label study starting with a     phase I dose escalation part followed by a phase II part.      PDR001 will be administered every 2 weeks until patient experiences unacceptable toxicity,     progressive disease per immune related Response Criteria (irRC) and/or treatment is     discontinued at the discretion of the investigator or the patient.   "
67345|NCT02404233|"     Current HIV treatment guidelines recommend the use of triple-drug therapy (two nucleoside     reverse transcriptase inhibitors and either a protease inhibitor, non-nucleoside reverse     transcriptase inhibitor, or an integrase inhibitor) for the treatment of antiretroviral     (ARV)-naïve patients. With the introduction of highly active antiretroviral therapy (HAART),     patients with HIV are living much longer. With the increasing lifespan of persons with HIV,     long-term complications from therapy as well as the occurrence of co-morbidities with aging     have prompted HCPs to re-think the current treatment paradigm and consider novel combinations     of ARVs. All of the currently approved HIV antiretrovirals have been implicated in causing     long-term toxicities; however the greatest body of evidence for long-term metabolic effects     has implicated the nucleoside reverse transcriptase (NRTI) class. By utilizing a non-NRTI     treatment regimen, it is hypothesized that many of these long-term metabolic effects (renal     toxicity, bone loss, body fat changes) can be delayed or avoided altogether. The clinical     data on novel combinations is currently limited but rapidly growing and has included several     combinations that have utilized darunavir. This study will be the first of its kind using the     unique combination of darunavir/cobicistat and rilpivirine. Currently, this drug combination     is not a recommended option for first time treatment of HIV   "
67378|NCT02403804|"     The goal is to assess whether, in adult women during the luteal phase of their menstrual     cycle, supplementing their diet with either phosphatidylcholine or betaine increases their     serum choline levels.   "
67330|NCT02404428|"     Prostate cancer is a major public health problem and there is a strong need of new preventive     strategies based on drug and lifestyle interventions. It is now well-established that healthy     eating patterns and increasing physical activity can prevent or delay prostate cancer     progression. Intake of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower, Brussels     sprouts, kale) has been associated with decreased risk of prostate cancer progression;     however the underlying biological mechanisms remain unknown. The investigators propose to     undertake a pilot study on a group of men with early prostate cancer on active surveillance     to determine whether a diet rich in broccoli will induce changes in tumor size and blood flow     measured by conventional Magnetic Resonance Imaging (MRI) techniques. Men with early prostate     cancer on active surveillance who have visible cancer lesions on MRI will be recruited onto     this double-blinded randomized intervention and they will be asked to eat one portion of     broccoli soup per week for 6 months. The investigators will test two varieties of broccoli     (standard and 'Beneforte extra' broccoli) that are able to deliver two different levels of     sulforaphane (SF), an active compound extensively studied for its potential anticancer     properties. This study will involve MRI scans, blood and urine collection before and after a     6 month intervention period. This study design will not only allow us to observe diet-induced     changes within the prostate but also at the systemic level. In addition, participant's     lifestyle (habitual diet and physical activity) will be assessed by food diaries and exercise     questionnaires.      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)     and Prostate Cancer foundation (PCF).   "
67331|NCT02404415|"     The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and     genetic biorepository that systematically enrolls patients undergoing atrial fibrillation     (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records     with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic,     and serological predictors of response to AF ablation in order to improve patient selection,     and 2) to provide a resource for translational research investigating the electrophysiologic     mechanisms of AF pathogenesis.   "
67332|NCT02404402|"     This study investigates the efficacy of a novel neuromodulation treatment, light emitting     diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with     traumatic brain injury (TBI).   "
67333|NCT02404389|"     This is a randomized, vehicle controlled, active comparator, parallel group, study with a     total duration of 24 weeks including screening and follow-up. Study drug is applied topically     for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study     endpoints are blinded to treatment allocation.   "
67334|NCT02404376|"     Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before     primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment     elevation myocardial infarction), but the reduction is limited. This study investigates     whether a combination therapy including both therapies is more effective.   "
67335|NCT02404363|"     Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine     tumor.      In a pilot study, the rate of microparticles was correlated with response rate of pancreatic     adenocarcinoma.      The aim of the study is;        -  to compare the phenotypes of coagulation, the tumor progression and metastasis formation          with and without clopidogrel treatment in association with chemotherapy in advanced          pancreatic cancer patients        -  to correlate the decrease of microparticles levels after one month of chemotherapy with          tumor response (ancillary study)   "
67336|NCT02404350|"     The purpose of this study is to demonstrate efficacy including effect on inhibition of     progression of structural damage, safety and tolerability up to 2 years with primary focus at     Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe     (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects     with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or     previous anti-TNFα therapy. Long term efficacy up to 2 years will be based on signs and     symptoms of joint/bone structure preservation (X-ray) and improvement in physical function     measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and     nail improvement for psoriasis signs.   "
67337|NCT02404337|"     Oral treatment with betaine is conventionally used for patients with inherited     homocystinurias.      These conditions include a first group of patients with a cystathionine β-synthase (CBS)     deficiency and a second group of patients with remethylation defects.      The aim of betaine therapy is to reduce level of total plasma homocysteine. Daily dosages and     rhythm of administration proposed in the literature vary between 100 to 250 mg / kg / d in 2     to 4 doses. These dosages are not based on validated data and several publications mention     much higher dosages particularly when total homocysteine is not controlled. These practices     may be unnecessary or even detrimental given the fact that high doses of betaine could for     example lead to secondary folate deficiency.   "
67339|NCT02404311|"     The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination.     HIV is the virus that causes AIDS.      About 252 people will take part in this study at multiple sites. The US National Institutes     of Health (NIH) is paying for the study.      The investigators are doing this study to answer several questions.        -  Are the study vaccines safe to give to people?        -  Are people able to take the study vaccines without becoming too uncomfortable?        -  How do people's immune systems respond to the study vaccines? (Your immune system          protects you from disease.)   "
67340|NCT02404298|"     Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated     disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy     for CIDP. The investigators used a transcriptomic approach to compare the gene expression     profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and     after IVIg treatment, in order to identify their mechanism of action in this condition, to     lead to a better understanding of CIDP pathophysiology, and potentially determine factors     associated with the response to the treatment.   "
67341|NCT02404285|"     This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild     to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or     vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes     at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.   "
67348|NCT02404194|"     This project is a randomized-controlled trial to test the efficacy of computer-based targeted     cognitive training (TCT) versus a placebo intervention of commercial computer games in     adolescent/young adults at clinical high risk (CHR) for psychosis. TCT is designed to     optimize learning-induced neuroplasticity in vulnerable neurocognitive systems. A main aim is     to test the hypothesis that this neuroscience-guided TCT intervention will improve neural     function, and that these neural improvements will improve cognition and functional outcome.     CHR participants will be randomly assigned to 40 hours of TCT or placebo computer games     completed within 10 weeks. TCT consists of 20 hours of training in cognition, including     processing speed, memory, attention, and cognitive control followed by 20 hours of training     in social cognition including affect recognition and theory of mind. Neuroimaging, cognition,     social cognition, clinical symptoms, and functional status will be assessed at baseline,     after 20 hours/5 weeks of cognitive training (mid-intervention), and after 20 hours/5 weeks     of social-cognitive training (post-intervention). Cognition, social cognition, symptoms, and     functioning will also be assessed at a 9 month follow-up (i.e. 9 months after intervention     completion). We predict that TCT will lead to improvements in neurocognitive function and     functional status. The results of this study will provide important information about a     benign, non-pharmacological intervention for improving cognition and functional outcome in     CHR individuals.   "
67360|NCT02404038|"     This study will enrol sexually active, healthy girls aged 16-17 to assess and compare the     acceptability and preference for a monthly vaginal ring, bi-monthly injectable contraception     or daily dose oral contraception, as proxy for female-controlled ARV-based HIV prevention     methods.   "
67415|NCT02403323|"     This two-part, open-label extension and safety monitoring study will examine the safety and     efficacy of continued etrolizumab treatment in patients with moderate to severely active     Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.   "
67349|NCT02404181|"     Delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized     by physicians and nurses, even when screening instruments are used. Electroencephalography     (EEG) appears to be a sensitive tool for the diagnosis of delirium. However, standard EEG     recording with 25 electrodes is labor intensive. We have previously showed that a brief EEG     registration with three electrodes and automatic processing can distinguish patients with     delirium from patients without delirium very well. However, these findings need to be     validated in an unselected population.      The primary objective of this validation study is to investigate the sensitivity,     specificity, and predictive values of the EEG-based delirium monitor (including three     electrodes and a reference electrode) compared to delirium quantification in frail elderly     patients after surgery.      In an international multicenter study, 154 frail elderly patients will be included who will     undergo elective surgery and are expected to remain admitted for at least two postoperative     days. Patients are excluded if communication is not possible or admitted for neurological     surgery.      A five minute EEG registration with the delirium monitor with four electrodes will be     performed prior surgery and three consecutive days after surgery or until discharge. Within     one hour of the EEG recording, the delirium assessment will be performed and recorded on     video, which will be evaluated by delirium experts. The relative delta power (calculated from     one minute of artifact-free EEG segment) will be compared with the conclusion of the delirium     experts.   "
67350|NCT02404168|"     The prior BEEP study involved patients being switched between brand and generic in a very     structured manner. Other secondary comparisons were also made (i.e. any differences in     adverse effects and seizure control). Some subjects were more disparate than other, in terms     of generic being similar to brand. In this follow up study, BEEP subjects that showed     disparate results will be tested again to assess reproducibility of disparate results.   "
67351|NCT02404155|"     Clozapine (CLZ) is the most effective antipsychotic for treatment-refractory schizophrenia     (SZ). Despite the overwhelming evidence of superior efficacy, CLZ is infrequently prescribed     in the US, at a considerably lower rate than the estimated prevalence of treatment-resistant     SZ, especially for African-Americans (AA). Recent evidence suggests that low Absolute     Neutrophil Counts (ANC), either at baseline or during treatment are a significant barrier to     CLZ use in AA patients in the US, where guidelines mandate CLZ discontinuation if ANC drops     below 1500 cells/mm3. The investigators group has found that discontinuation of CLZ in AA     patients is over twice that in European-American (EA) patients (N~400; 42% vs.19%, P=0.041)     and initiation rates are 50% lower. In a Statewide study (N=1875), the investigators reported     that discontinuation was more frequently due to neutropenia in the AA sample, though no AA     had developed agranulocytosis (8 cases in EA). Benign Ethnic Neutropenia (BEN) in people of     African ancestry, including AAs, identifies a group (50% of AA) with low ANCs but no     increased risk of agranulocytosis or infection. Low baseline or in-treatment fluctuations     requiring CLZ discontinuation under current prescribing guidelines are common in CLZ-treated     persons with BEN. In the investigators recent pilot study of N=12 AA patients with BEN,     treatment was safely and successfully continued with CLZ despite low baseline ANC (outside     current guidelines). Recent evidence implicates a polymorphism in the Duffy Antigen Receptor     Chemokine (DARC) gene in the pathophysiology of BEN. In homozygotes (FY-/-) for the DARC null     allele, mean within-subject neutrophil counts are reduced, resulting in sporadic ANC <1500     cells/mm3 in 10-15% of people with the allele. In population studies, the FY-/- genotype is     found in 0.01% of EAs, 99.3% of sub-Saharan Africans (SSA), and 68% of AAs. Further, a     missense DARC mutation has been reported to interact with the DARC FY-/- in determining low     WBC in AAs. Normal patterns of week-to-week fluctuation in ANC levels in individuals of     African ancestry with BEN and the DARC null genotype are not known, and no published research     has examined variation in ANC in African ancestry CLZ-treated SZ patients with BEN and the     DARC null genotype (FY-/-). Such data are also lacking on individuals with BEN without the     DARC null genotype. Conducting such research will generate genetic marker and safety data     that could be used to expand access to CLZ for AA patients who otherwise are eligible to     receive this superior treatment option.   "
67352|NCT02404142|"     In this prospective, randomized study, the investigators assess the intubation conditions     during videolaryngoscopy with Glidescope Titanium whether patients receive (curare     (Atracurium) group) or no (control group) within elective surgery patients with no difficult     intubation prediction   "
67379|NCT02403791|"     The purpose of this study was to evaluate the availability and diagnostic accuracy of     point-of-care bedside lung ultrasound examination in management of mechanical ventilation in     neonatal acute respiratory distress syndrome.   "
67380|NCT02403778|"     The purpose of this study is to assess the safety and efficacy of combined treatment with     Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.   "
67381|NCT02403765|"     The study aims to identify genetic variants associated to Parkinson's disease through the     analysis of exome-sequencing data of familial cases and controls. The identified variants     will be used to generate a diagnostic tool for the identification of genetic risk profiles.   "
67353|NCT02404129|"     As the geriatric population continues to rise, the consequences of falls and fall-related     injuries carry increasing socioeconomic significance. Fall during turning is 7.9 times more     likely to result in hip fracture than a fall while walking straight. Hence, turning carries a     significant risk for hip fracture. Turning is ubiquitous during activities of daily living,     yet most gait research has focused on straight ahead walking.      Turning affects lower limb kinematics, kinetics, and step parameters. Therefore it appears to     be a greater challenge for individuals with mobility problems. Turning ability is affected by     age changes and balance confidence. TURN180 test was built to assess the parameters of     turning. It has four major categories which are the most readily identified indictors of     difficulty in turning while walking. These categories are: (1) the type of turn (or strategy)     used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time     taken to accomplish the turn, and (4) staggering during the turn.      The purpose of this study is to explore the TURN180 test ability to evaluate the risk of     falling in the elderly population and compare it to the known gold standard clinical test.     This is a validation study of balance and mobility tests using a three-group sample of     convenience. The independent elderly subjects (n=75) will be divided into three groups     according to their falls history and undergo four balance tests: Timed Up and Go test     (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be     videotaped while performing the TUG test. Basic temporospatial aspects of turning during     walking such as the number of steps taken during the turn and the time taken to accomplish     the turn will be measured using both the slow-motion and stop-action capabilities of the VCR     system and a time-code processor.   "
67354|NCT02404116|"     The study involves a comparing a new psychological treatment- Metacognitive Therapy (MCT)     which has shown promising results in the treatment of health anxiety to no treatment at all-     a waiting list.   "
67355|NCT02404103|"     The purpose of this study is to see how two doses of Flunisolide HFA (an FDA approved inhaled     medication to treat asthma) affect the small airways in children with asthma.   "
67356|NCT02404090|"     Evaluation of the subchondral mineralization plate after excess weight loss in patientes     undergoing bariatric operation by means of CT-osteoabsorptiometry.   "
67357|NCT02404077|"     The investigators' clinical practice makes use of oral clonidine as a means of transitioning     from intravenous dexmedetomidine following prolonged infusions (more than 3-5 days). Although     this is common clinical practice, there is limited clinical data to demonstrate the efficacy     of this technique and to provide clonidine dosing guidelines. The purpose of this study is to     retrospectively review the investigators' experience with the use of oral clonidine to     prevent withdrawal following the prolonged administration of dexmedetomidine.   "
67358|NCT02404064|"     To compare surgical site infection (SSI) rate in patients undergoing laparoscopic     appendectomy for acute uncomplicated appendicitis and treated with single dose regime of     antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics     treatment. Patient will be given either single dose of perioperative antibiotics or no     antibiotics before surgery.   "
67384|NCT02403726|"     The purposes of this study were to analyse demographic, medical, gender and socio-economic     aspects of osteoporosis associated vertebral fractures.   "
67361|NCT02404025|"     This is an open label, non-randomized, phase II study of eltrombopag in combination with     rabbit ATG/CsA in subjects with moderate or more severe AA who have not received prior     ATG/ALG-based immunosuppressive therapy. The objective is to assess additive effects of     eltorombopag on overall response rate (ORR) at 6 months (Week 26) of treatment with ATG/CsA.     Subjects will be assessed at least weekly for safety during the period from the start of     ATG/CsA to 4 weeks after the start of administration of eltrombopag. After that, subjects     will visit every 2 weeks until Week 26. Subjects in whom the treatment is assessed as     effective at Week 26 may continue treatment with eltrombopag after 6 months when clinically     indicated at the discretion of the investigator. There are five follow-up visits: at     discontinuation of the treatment of eltrombopag, and Weeks 1, 2, 3, 4 and 26 after treatment     discontinuation. As this study is the first Japanese phase II study in which this product is     administered in combination with ATG/CsA to subjects with naive moderate or more severe AA,     the subject number of this study is determined to be 10 based on the feasibility survey.   "
67362|NCT02404012|"     There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and     effective therapies are lacking. Thus, there is a critical need for an effective,     non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and     improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric     surgery patient population. Often, patients do not participate in bariatric programs, are not     compliant, and/or are lost to follow-up. If there is a more effective and evidence-based     guideline for repletion of iron deficiency, patients are more likely to be compliant.     Therefore, in a randomized controlled study, the investigators propose to test the     effectiveness of various iron formulations versus ferrous sulfate, which is the standard of     care, for oral iron supplementation of iron deficient patients who have had RYGB or SG     bariatric surgery. By randomizing patients into the two groups, the investigators will be     able to determine the most effective regimen to improve blood biomarkers of iron status,     cognitive function, and quality of life. Other outcomes will include adverse effects and     compliance to the supplementation. The investigators will also analyze three-day food records     to determine the contribution of dietary factors to changes in iron status. To test for     improvement of iron status, serial blood draws will be performed during a time period of ~10     weeks. Serial blood draws from iron deficient patients have routinely been performed in past     studies and have not been found to be harmful. Because this is a relatively short study (10     weeks), subjects will be able to recover quickly from the blood loss during the study. The     investigators expect to find that iron supplementation with organic formulations of iron will     be as effective than ferrous sulfate for repletion of iron deficiency, and they will be     better tolerated. This project will address a significant health issue in individuals who     have had bariatric surgery, which is a growing population in the United States. It is     estimated that almost 1.5 million individuals have undergone bariatric surgery since the year     1990.   "
67363|NCT02403999|"     This will be a single centre, evaluator blind, randomized, parallel group, stratified, two     week study in healthy participants. The clinical study is designed to provide reassurance     that the formulations developed for children and babies with mild to moderately dry skin and     for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the     target population, babies and young children with dry skin.   "
67364|NCT02403986|"     A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three     initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.      Approximately 50 female subjects shall be treated with two or three initial treatment     sessions including long-term follow-up 18 months after the initial treatment regimen.   "
67365|NCT02403973|"     To explore the possible benefit of a patient hotel, a study was undertaken to test the     hypothesis that perioperative care at a patient hotel would be valued better than care in a     general ward. The study focuses solely on the patients' perspective and satisfaction of the     care provided.   "
67366|NCT02403960|"     Aim: to evaluate the additional effects of the 12 weeks usage of a Streptococcus containing     probiotic tablet after scaling and rootplaning compared to a placebo tablet.      Materials and methods: 48 periodontitis patients were included in this double-blind,     placebo-controlled trial. After scaling and rootplaning, they were given patients used either     a placebo (SRP) or probiotic tablet (SRP + P), 2 times a day for 12 weeks. Clinical and     microbiological parameters were studied recorded up to 24 weeks after scaling and     rootplaning.   "
67367|NCT02403947|"     Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system     (CNS), which ultimately leads to myelin damage and axonal loss. The disease is complex and     multifactorial, but the key pathogenic event appears to be an uncontrolled response of     components of the immune system (T and B lymphocytes) to myelin proteins. No definitive     treatment is available for MS, however immunomodulatory and immunosuppressant drugs act as     disease-modifying agents (DMDs).      Unfortunately, the current treatments demonstrate partial efficacy in targeting the     deleterious immune reactions. According to the present knowledge of the pathophysiology of     MS, an ideal therapeutic strategy would be to modulate or suppress the aggressive immune     process, to protect axons and neurons from degeneration, and to enhance repair and facilitate     remyelination.      A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown     remarkable ability to modulate the immune response. This study will evaluate the safety of     injecting MSCs in people with MS.   "
67368|NCT02403934|"     Maintaining a patent airway is a constant concern to any anesthesia provider performing deep     sedation cases. The doses of sedative medications often required for the desired level of     sedation in a patient often result in occlusion of the airway and the patient becoming     apneic. Opening the collapsed or occluded airway requires the use of an invasive airway     device, (e.g. laryngeal mask airway (LMA), oral airway or nasal airway) or the application of     a jaw thrust maneuver. When the provider provides jaw thrust while attending to the other     duties, the patient may not have adequate ventilation and the patient's oxygen saturation can     fall producing hypoxemia. Airway management devices currently available require deeper levels     of sedation to be tolerated by patients. In order to avoid the need for internal airway     devices, providers attempt to carefully adjust the level of sedation so that no airway     support is required. For safety, providers usually try to stay on the light side of the     sedation scale. Unfortunately, this often results in an uncomfortable patient or one who is     moving too much to successfully carry out the procedure. Until the availability of the Jaw     Elevation Device (JED) there was no external device providers could utilize to assist in     opening a patient's airway. By duplicating the jaw thrust maneuver, the JED maintains a     patent airway. Once applied, it frees the anesthesia provider to attend to other duties     associated with administration of anesthesia without requiring the provider to manually     maintain a jaw thrust maneuver. The advantages with such a device would allow a level of     sedation deep enough for the patient to tolerate the procedure as well as maintain a patent     airway. To date, there have not been any studies evaluating the JED in clinical practice. The     investigators wish to evaluate the JED in a standardized fashion during deep sedation or     monitored anesthesia care (MAC). Our study would involve 50 patients who became apneic during     deep sedation or MAC. A jaw thrust maneuver will be initially performed to demonstrate that     each patient's airway can be adequately supported by this maneuver. The JED will then be     placed in order to maintain a patent airway, while leaving the level of sedation unchanged.     Intraoperative monitoring, continuous ECG, pulse oximetry, blood pressure, capnography, will     be routine, and determined by the anesthesia team. The investigators will also track how     often the provider was required to adjust the JED to maintain a patent airway, and if the     need to convert to an alternate method of airway management was required. The investigators     will pursue publication of the results as the first study demonstrating the efficacy of the     JED.   "
67369|NCT02403921|"     The investigators aim to investigate the association between hair, serum, urine and saliva to     measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine.   "
67385|NCT02403713|"     A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a     pressurised metered dose inhaler (pMDI) with and without spacer.   "
67370|NCT02403908|"     The aim of research proposal is to assess and compare the safety and efficacy of     radiofrequency denervation of pulmonary arteries on decrease in pulmonary vascular resistance     and mean pulmonary artery pressure (MPAP) in 20 patients with IPAH (mean pulmonary artery     pressure >25 mmHg) and in 20 patients with secondary pulmonary hypertension due to pulmonary     disease or due to left heart disease not responding optimally to medical therapy.   "
67371|NCT02403895|"     Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of     AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)   "
67372|NCT02403882|"     The investigators run a series of behavioral economic interventions at client-choice food     pantries to encourage clients to choose targeted foods.   "
67373|NCT02403869|"     Post-authorization, prospective follow-up, multi-centre, national study to estimate     definitive deterioration in the quality of life in patients with metastatic breast cancer     treated with second-line monochemotherapy.   "
67374|NCT02403856|"     Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder.     Needling and lavage of the calcification is one of the therapeutic options after failure of     conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually     followed by a corticosteroid injection in the subacromial bursae in order to prevent acute     pain reaction due to the intervention. However, the relevance of this injection has never     been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the     needling and thus the body's natural calcium resorption processes. Finally, corticosteroids     could have deleterious effect on the tendon structures and favour local infection. Our     hypothesis is that corticosteroid have no significant effect on acute pain after needling and     therefore should not been performed systematically after needling.   "
67375|NCT02403843|"     The purpose of the study is to follow patients with partial onset seizures prospectively over     5 years in the real-world environment to gather data on the long-term safety and     effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists,     and neurosurgeons trained on the RNS System.   "
67376|NCT02403830|"     Ticagrelor is associated with more prompt and potent antiplatelet effects compared with     clopidogrel, leading to better clinical outcomes, including reduced cardiovascular mortality,     across the spectrum of patients with acute coronary syndrome, including those with     ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary     intervention (PCI). However, in this latter setting a delay in the onset of its antiplatelet     effects has been shown. Morphine has been identified as a cause of delayed P2Y12 inhibition     in patients with STEMI. Methylnaltrexone is a parenteral peripheral opioid receptor     antagonist which has the potential to prevent or reverse opioid-induced peripherally mediated     side effects without affecting analgesia. However, whether the use of intravenous     methylnaltrexone may overcome the effects of morphine administration on the pharmacokinetic     (PK) and pharmacodynamics (PD) profiles of ticagrelor has not been investigated yet. The     proposed investigation will include patients with coronary artery disease and will have a     prospective, randomized, cross-over design.   "
67377|NCT02403817|"     Current therapies for autism target social and language behaviors, but due to the high-level     nature of these skills any improvement rarely extends beyond the targeted behavior. This     project uses new technology to implement a novel concept for behavioral intervention to     improve basic attention and eye movement skills in ASD. Because these basic skills form the     foundation for good social communication, training these abilities has the potential to     improve a broad spectrum of clinical symptoms, and in young children may affect the course of     development.   "
67382|NCT02403752|"     Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for     ambulatory individuals with dementia and caregivers living at home based on recruitment,     adherence and retention. Investigators will conduct a pilot randomized controlled trial (RCT)     with 20 dyads (total N = 40) in groups of 5 randomized to 16-week group exercise classes and     regular home practice or wait list in a cross-over design. Investigators will assess     feasibility of enrollment and retention, the proportion of completed outcome measures, and     adherence by class attendance logs, caregiver-reported home practice logs and qualitative     interviews to assess ease of implementation in the home environment. Investigators will     explore feasibility of weekly phone calls to (potentially overwhelmed) caregivers and Fit-bit     accelerometers as a measure for tracking home practice.      Specific Aim 2: To collect preliminary effect size data for sample size calculation for a     larger trial. Investigators will assess standard outcomes (such as the Short Physical     Performance Battery and Alzheimer's Disease Assessment Scale - cognitive subscale as primary     outcomes for affected individuals; and Caregiver Burden Inventory for caregivers) commonly     used in pharmacological studies of individuals with dementia at baseline, 16 and 32 weeks and     calculate effect sizes (Cohen's d) for between-group differences in outcome changes in the 20     dyads of the RCT described in Specific Aim 1.      Specific Aim 3: To explore the feasibility of using non-invasive Near-Infrared Spectroscopy     (NIRS) to assess regional cortical brain oxygenation and its sensitivity to change.     Investigators will compare brain oxygenation variations before and after the exercise     intervention during a memory task for the seniors with dementia.   "
67383|NCT02403739|"     Simulated growth data will be shown to clinicians in two formats - (1) as weight vs.age     charts, (2) as weight Z-score vs. age charts. Clinicians will be asked to identify whether     growth is too fast, too slow, or normal. The test will take a total of 10 minutes.   "
67386|NCT02403700|"     Bone modeling after tooth extraction has a major consequence on implant therapy, in     particular in the esthetic zone. In esthetic sites, no tissue loss should occur if an optimal     esthetic outcome is expected. Recent experimental studies in dogs have shown that neither an     immediate implant insertion nor ridge preservation techniques can prevent this bone modeling     process.   "
67387|NCT02403687|"     A 24-week observational prospective study on the efficacy of topical non-steroidal     anti-inflammatory drugs for the relief of pain.   "
67388|NCT02403674|"     The purpose of this study is to compare the antiretroviral activity of MK-1439A, a     single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing MK-1439 100 mg +     lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC     containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in     treatment-naive participants infected with HIV. The primary hypothesis is that MK-1439A q.d.     is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1     ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48.   "
67389|NCT02403661|"     The primary goal of this study is to quantify the functional deficits caused by injuries to     the brachial plexus and peripheral nerve in the arm. The second goal is to test the possible     benefit of electrical stimulation of the injured nerve following surgery. The investigators     will test whether electrical stimulation will improve hand function and nerve regeneration     after repair for nerve injury. Injuries causing nerve damage in the arm and hand are common.     In severe cases, functional outcomes even with surgery remain poor. Recently, electrical     stimulation has been applied to injured nerves in rats. This was shown to improve nerve     regeneration. These studies showed that as little as one hour of electrical stimulation was     effective. Therefore, the investigators plan to test this new method of treatment to     determine whether it is also helpful in humans. These will be done by using a symptom     severity questionnaire, nerve conduction studies and by testing pressure sensations, hand     dexterity and strength. The patients will be randomized to either the treatment or control     group. Following the treatment, all baseline measurements will be reevaluated every three     months for the first year and every 6 months during the second year. The timing and nature of     the evaluation process will be identical in both groups.   "
67390|NCT02403648|"     BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes     (reconstitutes) the powder with liquid to make it easier for users to treat patients with     severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into     the bloodstream, how much it raises glucose concentrations (the intended effect) and compare     to two glucagon products already on the market.   "
67391|NCT02403635|"     CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo the     induction effect of ASP2151 on that enzyme to determine the extent of any possible drug     interactions. The aim of this trial is to investigate the potential for interaction of     ASP2151 with the CYP3A4 probe substrate midazolam.   "
67392|NCT02403622|"     The overarching objective of this study is to address the knowledge gap regarding the     short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a     prospective, open-label, multi-center longitudinal cohort study to assess the short- and     long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients     with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools     over 24 hours for 2 consecutive days and either a positive stool test for CDI or     pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to     one of the study centers after at least three recurrent episodes of CDI and previous     treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by     colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for     clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment),     8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who     recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis     will be conducted from stool samples at baseline and each of the 5 follow-up intervals.   "
67393|NCT02403609|"     The purpose of this study is to evaluate test-retest reliability of each subtest (correlation     coefficients for Time 1 and 2) in the Brain Performance Test (BPT, Lumos Labs, Inc.).   "
67394|NCT02403596|"     This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood     loss using two dosage regimens (standard and extended) after a surgery during total hip     arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for     prophylaxis of thrombosis.   "
67401|NCT02403505|"     That current oncology drugs on USA market have the universal problems about low effectiveness     of pharmacology to cancer cells and high risk of toxicology to normal cells can demonstrate     following most significantly and most reasonably: it is not enough so far away that just only     oncology drug target molecules as cancer patient-specific biomarkers directly; it must be     that oncology drug targets' SNPs like as real personalized or individualized cancer     patient-specific biomarkers.   "
67402|NCT02403492|"     Heart disease is a major cause of ill-health and death in adults. The risk factors for heart     disease, if present in children, carry over into adult life. Childhood obesity has reached     epidemic proportions in Canada and is associated with many heart disease risk factors such as     high blood pressure. Another complication of obesity is obstructive sleep apnea. Sleep apnea     is marked by snoring at night, pauses in breathing and low oxygen levels and occurs in up to     60% of obese children, but it is diagnosed in less than 20% of obese children. Importantly,     sleep apnea in children, like obesity, is linked with high blood pressure and heart disease.     Thus, children with sleep apnea who are obese are likely to have an increased risk for high     blood pressure and heart disease. Currently, there is little knowledge of the extent of heart     disease in obese children with sleep apnea.      The best treatment for both obesity and sleep apnea is weight loss. Weight loss strategies     are generally not very successful and since 75% of obese children will become obese adults,     urgent treatments are needed to reduce heart disease in the long-term. Treating sleep apnea     in obese children may be one of the ways to reduce heart disease. Sleep apnea can be treated     with continuous positive airway pressure (CPAP), which involves wearing a mask attached to a     breathing machine while asleep. It is unknown how effective CPAP is in reducing heart disease     in obese children.      The investigators will recruit children with sleep apnea who are obese and test for heart     disease risk. The investigators will then treat these children with CPAP. After 6 months of     CPAP, the investigators will repeat the tests to determine if CPAP lowers the risk for heart     disease. At the end of the 6 months, those receiving CPAP will be randomized to either     continue CPAP or discontinue CPAP for a 2 week period. At the end of the 2 week period the     participants will repeat the tests again to determine the magnitude of the effect of CPAP.      The investigators expect that CPAP treatment for sleep apnea in obese children will reduce     blood pressure and lower heart disease. These results will increase awareness of the dangers     of sleep apnea in obese children, which will facilitate early diagnosis and treatment,     ultimately reducing heart disease long-term.   "
67403|NCT02403479|"     Chronic rhinosinusitis without polyposis (CRSsP) is a very common condition that occurs when     the lining of the sinuses becomes persistently irritated. Standard management options include     topical steroids, antibiotics and surgery, but treatment-resistant CRSsP is frequently     encountered. Bacterial biofilms are routinely detected within the nasal mucosa of CRSsP     patients and are now thought to play an important role in the protracted nature of the     disease. Colloidal silver is a widely used naturopathic agent that has recently been shown to     eliminate bacteria, and in particular in vitro sinusitis biofilms, in laboratory studies.     Although silver is currently used in a variety of chronic wound therapies, it has not yet     been formally studied in people with CRSsP. It is our intention with this project to     determine whether colloidal silver is a useful treatment strategy for patients with     refractory CRS.   "
67404|NCT02403466|"     Because communication and handoff failures are a root cause of two-thirds of sentinel     events- serious, often fatal preventable adverse events in hospitals improving handoffs has     been identified by AHRQ and the Joint Commission as a priority in nationwide efforts to     improve patient safety. Comparative Effectiveness Research on handoff tools and processes has     identified specific strategies to improve handoffs and reduce medical errors: 1) team     training; 2) verbal mnemonics; and 3) use of written/computerized tools to supplement verbal     sign-outs. To accelerate residents' use of CER-based handoff practices and improve patient     safety, the investigators are implementing the three inventions above as a Resident Handoff     Bundle (RHB) in eight pediatric hospitals in the United States and Canada.   "
67405|NCT02403453|"     A Prospective, open label, multi-center observational study of patients requiring surgical     treatment at one or two (contiguous) cervical spine levels. The primary objectives of the     RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments     and surgical technique; confirm device performance in terms of clinical and radiographic     outcomes; confirm device performance in terms of safety and to collect original data to be     compared to published reports of the performance of comparable motion-sparing devices, as     well as clinical outcomes of fusion devices.   "
67406|NCT02403440|"     The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics     (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP.   "
67407|NCT02403427|"     The purpose of this study to conduct the preliminary investigation on the efficacy and safety     in terms of postprandial glucose value and the rates of hypoglycaemia when expert VoiceDiab     system supports patient's decision on prandial insulin programming in insulin pump therapy.   "
67408|NCT02403414|"     Acromegaly is associated with increased risk of difficult intubation and its management. The     overall incidence of difficult intubation in patients suffering from acromegaly is four to     five times more than those without acromegaly.The difficult intubation scenario in these     patients can be managed by various methods ranging from awake fiberoptic intubation to     tracheostomy. Difficult tracheal intubation accounts for 17% of respiratory-related injuries     and results in significant morbidity and mortality in general population. In patients with     acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia related     deaths. Therefore, the need and importance of airway assessment in patients with acromegaly     cannot be overemphasized. Various tests of airway assessment have to be used to assess     difficult airway and tracheal intubation in acromegalics.      The investigators aim to assess the various tests of airway assessment affecting the outcome     of patients with acromegaly undergoing pituitary surgery and identify which was best suited.   "
67409|NCT02403401|"     Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing     intravaginal ring.   "
67410|NCT02403388|"     Avoidable care associated incidents are relatively frequent in primary care. In France for     example, avoidable incidents rate is estimated to 22/1000 medical acts from general     practitioners. Patient safety is now a growing issue in primary care. One tool to increase     patient safety is incident reporting and analysis. It could reduce some important     consequences for patients and could allow implementing substantial corrective actions.      The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk     management program implemented in the french pluridisciplinary offices in primary care in     association with a centralized incident reporting system, versus a centralized incident     reporting system only.   "
67411|NCT02403375|"     This study is to compare metabolic control, treatment satisfaction, and quality of life     during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump     system with multiple daily injections (MDI) therapy. Furthermore, this study will add     clinical data originating from clinical investigation in a special population, i.e. children     and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight     insulin pump.   "
67422|NCT02403232|"     Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported     incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea,     respectively. Uncontrolled chronic inflammation finally causes various complications in     intestine such as bowel obstruction, fistulas, abscesses, and anal fissures.      The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease.     Medical treatment for Crohn's fistulae initially focused on surgical intervention accompanied     by symptomatic treatment with antibiotics and immunosuppressants. The most serious problem     after surgical intervention is the relatively high incidence of postoperative anal     incontinence caused by sphincter injury during the procedure. Conversely, available     pharmacological therapies for Crohn's fistulae based on biologic agents such as infliximab do     not generally reach ideal goal of treatment (e.g., complete closure of the fistula). A high     recurrence rate after treatment with infliximab has also been reported, even after long-term     maintenance therapy, which suggests that infliximab monotherapy does not provide adequate     healing.      The ACCENT II study demonstraded a complete fistula healing in 25% of patients. To reach a     better clinical outcome, combination treatment with infliximab and surgical intervention is     highly recommended for management of Crohn's fistulae. Nonetheless, even this strategy does     not result in a satisfactory healing for many patients.      The ideal therapeutic goal of treatment is not only complete closure of the fistula without     recurrence but also preservation of anal sphincter function. Unfortunately, currently     available medical or surgical treatment is not likely to offer a cure for perianal fistulae     and, as noted above, recurrence is frequently reported.      Together with active research in the field of bone marrow-derived mesenchymal stem cells     (BM-MSCs) and hematopoietic stem cells, autologous or allogenic adipose tissue-derived stem     cells (ASCs) have been studied for management of Crohn's disease and other disorders.      Of particular relevance to this study, ASCs could be considered to be safe and efficacious     therapeutic tools for the treatment of Crohn's fistulae. Importantly, ASCs do not cause fecal     incontinence after injection into the lesion site in Crohn's disease patients. A phase I     dose-escalation clinical study with ASCs manufactured by Anterogen Co., Ltd. (Seoul, Korea)     demonstrated the safety and therapeutic potential of these cells for the treatment of Crohn's     fistulae. A phase II study demonstrated a good rate of cronh's related fistula closure using     a ASCS injection.      Actually the best accepted treatment of Crohn related perianal fistula, is the surgical     procedure in association whit medical therapy.   "
67423|NCT02403219|"     This is a prospective, comparative, contralateral eye study. Patients older than 18 years who     have had treatment with topical lubricants for at least 1 month and persist with symptoms of     dry eye and corneal staining with fluorescein were included. Patients with dry eye     attributable to abnormalities of the eyelids, nasolacrimal obstruction and active corneal     infection, as well as patients with severe dry eye were excluded from the study. One eye     randomly received a subcutaneous injection of botulinum toxin in the medial part of the lower     eyelid, and the other eye received a similar procedure with placebo. The subjective     evaluation was achieved with a questionnaire assessing symptoms of dry eye and     conjunctivitis, quality of vision and ocular comfort level each eye separately. The objective     evaluation included the measurement of the tear film break up time, Schirmer's test and with     a modification of the Oxford grading scheme for corneal and conjunctival staining.   "
67424|NCT02403206|"     The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual     capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a     cataract with a pressurized capsular bag.   "
67425|NCT02403193|"     The purpose of this study is to determine the safety, tolerability, feasibility and     preliminary efficacy of the administration of PBF-509 (Adenosine A2a receptor antagonist) as     single agent or in combination with PDR001 (programmed cell death 1 receptor antibody (PD-1     Ab)) to NSCLC patients.   "
67426|NCT02403180|"     The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF     daily disposable contact lenses in an established presbyopic population.   "
67427|NCT02403154|"     The purpose of this research is to compare patient outcomes of two treatment methods that are     currently used as standard of care to treat anterior pelvic ring injuries that require     stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and     external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization     and participate in one of the observational arms. The first observational arm is comprised of     those patients who do not want to randomize and they will undergo anterior pelvic ring     stabilization according to the treating surgeon's discretion. The second observational arm     will be comprised of patients who consent to be in the study but whose pelvic ring fractures     do not require any form of anterior pelvic internal fixation based on the treating surgeon's     opinion.   "
67428|NCT02403141|"     Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing     awareness, remains under-diagnosed. There is a close association between OSA and obesity;     60-70% of patients diagnosed with OSA are either obese or overweight [1]. OSA is also very     common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached     epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain     through sleep disturbance [2]. Several mechanisms have been proposed for the associations of     OSA with diabetes and obesity [3]. At present there is little available information regarding     the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of     OSA on health outcomes in the Emirati population. This research will explore these     relationships and inform public health decisions regarding diagnostic pathways, service     provision and treatment protocols.   "
67429|NCT02403128|"     Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal     injection of aflibercept on eyes with symptomatic macular edema from retinal artery     macroaneurysms.   "
67430|NCT02403115|"     The purpose of this study is to clarify the mechanisms involved in the formation and     glomerular deposition of immune complexes in lupus nephritis.      The determination of an antibody pattern specific for systemic lupus erythematosus and lupus     nephritis may also have a role in predicting disease progression in patients with systemic     lupus erythematosus without renal impairment. As for the patients enrolled in the study, the     determination of their antibody patterns may contribute to a more targeted and personalized     treatment, allowing a prediction of disease progression and the introduction of early     targeted treatments, in order to block the onset and/or progression of renal damage.   "
67431|NCT02403102|"     Theranostics is the use of a diagnostic test to decide which patients will benefit from a     certain treatment.      The current standard treatment for patients with myeloma is induction chemotherapy followed     by peripheral stem cell transplant. Although there are options for timing of treatments,     patient outcomes are variable and the investigators do not currently know which patients     benefit from which treatment schedule. There is evidence to suggest that residual disease on     imaging after treatment is an indicator for a worse prognosis, however the best time point     for this imaging is currently not known. This study is designed to show if there is an     optimum time point for correlation between imaging and prognosis.      Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and     the investigators will confirm this when patients are first diagnosed, by performing both FDG     PET/CT and whole body diffusion weighted MRI.      Patients will then be followed up with whole body diffusion weighted MRI after induction     chemotherapy and 3 months post autograft. The investigators will look at the amount of     disease present on these scans and correlate this with outcomes.      There are likely to be other factors which influence patient outcomes (such as genetics) and     the investigators will also look at some of these. Patients who undergo autograft have     regular blood tests and marrow samples taken as part of routine care, the investigators will     use some of these samples (without compromising the patients treatment) to analyses some of     these other factors. If the investigators are able to determine a correlation of genetic     factors with outcome this information could be used in future research.      Theranostics is the use of a diagnostic test to decide which patients will benefit from a     certain treatment.      The current standard treatment for patients with myeloma is induction chemotherapy followed     by peripheral stem cell transplant. Although there are options for timing of treatments,     patient outcomes are variable and the investigators do not currently know which patients     benefit from which treatment schedule. There is evidence to suggest that residual disease on     imaging after treatment is an indicator for a worse prognosis, however the best time point     for this imaging is currently not known. This study is designed to show if there is an     optimum time point for correlation between imaging and prognosis.      Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and     the investigators will confirm this when patients are first diagnosed, by performing both FDG     PET/CT and whole body diffusion weighted MRI.      Patients will then be followed up with whole body diffusion weighted MRI after induction     chemotherapy and 3 months post autograft. The investigators will look at the amount of     disease present on these scans and correlate this with outcomes.      There are likely to be other factors which influence patient outcomes (such as genetics) and     the investigators will also look at some of these. Patients who undergo autograft have     regular blood tests and marrow samples taken as part of routine care, the investigators will     use some of these samples (without compromising the patients treatment) to analyses some of     these other factors. If the investigators are able to determine a correlation of genetic     factors with outcome this information could be used in future research.   "
67432|NCT02403089|"     The objective of this study is 1/ to determine the rate and kinetics of MAIT cell expansion     and maturation in neonates in relation with gestational age, and in HSCT recipient children     in relation with the source of donor stem cells, 2/ to correlate gut microbiota diversity and     function with MAIT cell maturation and function in neonates and HSCT recipients; and 3/ to     link MAIT cells and gut microbiota composition with microbial infections and severe     intestinal inflammatory events in term and preterm neonates, and in HSCT recipients   "
67433|NCT02403076|"     Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a     few data exists for the emergency management of patients with acute gastrointestinal     bleeding. The aim of our study is to develop optimal diagnostic and therapeutic algorithms     for the management of acute upper and lower gastrointestinal bleedings.   "
67434|NCT02403063|"     It was recently shown that neostigmine reversal was associated with increased atelectasis and     that high-dose neostigmine was associated with longer postoperative length of stay and with     an increased incidence of pulmonary edema and reintubation. These study results were     consistent with findings from a previous epidemiological study which revealed an absence of     beneficial effects of neostigmine on postoperative oxygenation and reintubation. In our     previous study, the effects of neostigmine / glycopyrrolate and sugammadex on the     electromyographic activity of the diaphragm showed beneficial effects for sugammadex. This     could be explained by a possible effect on neuromuscular transmission at the muscle level,     but can also be explained by a neostigmine-induced decrease in total nerve activity. In a     study in cats, neostigmine has been shown to reduce efferent phrenic nerve activity. The     investigators aim to show a difference in phrenic nerve activity between neostigmine and     sugammadex, administered alone or in combination, in healthy male volunteers.   "
67435|NCT02403050|"     Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated     with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy,     a Computerised tomography (CT) scan is performed and is the dataset used for planning     radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine     staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised     on CT. This information is subjective and dependant on the clinician performing the     procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of     this information can lead to over-compensation when attempting to cover the tumor with a     radiation field, to avoid a miss. It is thought that using fiducial markers called     Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of EUS, will     lead to better definition of the tumor in the planning process and hence, improvement in     local tumor control, and reduction in radiotherapy dose to normal tissue.   "
67436|NCT02403037|"     To evaluate the feasibility of a three-parallel-arm, placebo-controlled randomized trial     using a standard auricular acupressure protocol for managing nausea and vomiting in a     homogenous group of female breast cancer patients undergoing chemotherapy.      The null hypotheses of this study are: (1) There will be no significant difference in     acute/delayed nausea and vomiting among groups during the intervention period; (2) There will     be no significant difference in anticipatory nausea and vomiting among groups before the     second cycle of chemotherapy; (3) There will be no significant difference in quality of life     status among groups at the end of the first cycle of chemotherapy.   "
67437|NCT02403024|"     Background: The level physical exercise is strongly associated with colorectal cancer risk in     the general population, and recent data shows that physical activity after a colorectal     cancer diagnosis is inversely associated with mortality risk, indication the physical     exercise can protect against disease progression. However, few studies have successfully     performed exercise interventions in patients with colorectal cancer, and the potential     mechanisms responsible for the tumor suppressing effects of exercise remain poorly explored.      Purpose: To investigate interval-walking, delivered by the InterWalk smart phone application     as exercise-modality in patients with colorectal cancer. Specifically it is the aim to     explore if InterWalk is safe and feasible as well as effective to improve cardio-metabolic     health profile.      Subjects: Colorectal cancer patients, stage I-III, who are at least one month post-surgery     and have concluded any adjuvant chemotherapy treatment, are eligible for inclusion. Exclusion     criteria are: age <18; any major surgical procedure planned within 6 months after inclusion;     pregnancy; ongoing treatment for any known malignancy; performance status > 1; unable to read     and understand Danish      Methods: 40 colorectal cancer patients are included and randomized to I) InterWalk or II)     waiting list control for 24 weeks. Patients are evaluated at baseline, week 12 and week 24 by     assessment measures to determine cardio-metabolic health profile and other relevant study     outcomes, including: cardiopulmonary exercise test (VO2peak); anthropometrics; blood     pressure; resting heart rate; body composition; health related quality of life     questionnaires; plasma concentration levels of cholesterol, triglycerides, insulin, glucose     and inflammatory cytokines; insulin sensitivity; and cognitive function.   "
67438|NCT02403011|"     This study investigates the effect of soft tissue mobilization in babies with neck muscle     problem. Babies received soft tissue mobilization or home exercises program   "
67439|NCT02402998|"     A clinical study to evaluate the efficacy of a drug called eltrombopag in adult patients     affected of primary immune thrombocytopenia as first treatment to address the disease.   "
67440|NCT02402985|"     This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes     investigates the nutrition influence of animal protein in comparison to plant protein on the     glucose metabolism.   "
67441|NCT02402972|"     To investigate whether intraoperative intraportal chemotherapy combined with adjuvant     chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative     colorectal cancer resection compared with adjuvant chemotherapy alone.      This is a prospective, blind (doctors who done outcome measures were masked), multi-center,     2-arm randomized controlled trial.   "
67442|NCT02402959|"     The primary purpose of this study is to discover, establish and refine the individual     treatment protocol of each TCM expert for insomnia, and to explore what characteristics of     the patients are considered with the corresponding treatment in clinical practices.      The secondary purpose is to determine the effectiveness of TCM pattern differentiation     treatment for the patients with insomnia.   "
67443|NCT02402946|"     Rumination syndrome is characterized by effortless recurrent regurgitation of recently     ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a     previous study we showed that rumination is produced by an unperceived, somatic response to     food ingestión. After having identified the key mechanisms of rumination, we developed an     original EMG guided biofeedback technique with specific targets for correction, based on     EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the     potential effectivity of this treatment. In a subsequent study this technique was validated     by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of     a simplified biofeedback technique not requiring EMG-guided control.   "
67444|NCT02402933|"     Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at     time of enrolment will be selected for inclusion in the study. The target is to obtain     treatment response and user-experience data following use of AMG504-1 (LY900018) in treating     episodes of hypoglycemia.   "
67445|NCT02402920|"     The goal of this clinical research study is to find the highest tolerable dose of     pembrolizumab (also called MK-3475) and radiation therapy (either with chemotherapy or alone)     that can be given to patients with SCLC.   "
67446|NCT02402907|"     The objective of this study is to determine if the use of chlorhexidine gluconate cloths     prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site     infections, endometritis).      The study will be offered to women who present for a scheduled primary or repeat cesarean     section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2%     chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the     night before and the morning of their scheduled procedure. Participants will be blinded to     the arm in which they have been assigned. This study intends to show that the use of 2% CHG     cloths prior to cesarean section will reduce the rate of surgical site infections.   "
67447|NCT02402894|"     The purpose of the study is to study how a person-centered structured team caretaking of     young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA)     and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and     ability to manage their everyday lives. Also included in the project is a long-term follow-up     (up to 50 years) where the investigators want to investigate factors predicting good general     health, low disease activity, good physical function, and comorbidity.   "
67448|NCT02402881|"     The investigators have recently developed a registry of missed doses of VTE prophylaxis that     includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE     prophylaxis refusal, the group has developed a patient-centered education bundle that will be     delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting     education materials include a 2-page education sheet and an educational video.      The investigators hypothesize that patient refusal of VTE prophylaxis is associated with     significant knowledge gaps among patients regarding their risk of developing VTE and the     benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse     VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.   "
67449|NCT02402868|"     This study will examine the effectiveness of intranasal (IN) ketamine compared to standard     intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the     paediatric population. The aim is to assess if IN administration is equivalent to the current     standard of care, IV. The population to be studied is children 5-17 years of age who require     a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty     in masking interventions, each participant will recieve both IV and IN interventions, only     one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed     using the University of Michigan Sedation Scale (UMSS).   "
67450|NCT02402855|"     This study aims to evaluate the impact of financial support on improving the management of     prenatal care in pregnant women with low incomes. The judgment criterion is clinically     pertinent: complications of pregnancy. This study also aims to evaluate attitudes to this     approach through a qualitative survey.      It is planned to include 4000 women distributed into two arms of 2000 each. One group will     receive financial support (prepaid payment card credited for each consultation attended     according to the scheduled follow-up as recommended by the Haute Autorité de Santé); the     other group will not. The management of the pregnancy for both groups will not be modified.   "
67451|NCT02402842|"     Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an     early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and     5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure     (including salvage surgery), cisplatin-5FU combination is the standard option but complete     response is a rare event and the prognosis remains poor with most patients' death occurring     in the first 12 months. Decision making for physicians in this setting is only based on     retrospective studies or small phase II clinical trials including less than 20 patients.     Hence, no efficient standard of care is currently available for relapsing SCCA patients who     are currently treated with a palliative intent.      Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were     treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer     Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved     a complete response. Three patients underwent surgery of all involved metastatic sites. A     pathological complete response was observed for all of them including in metastases occurring     in irradiated fields, suggesting that taxane-based chemotherapy might be an effective     strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was     published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were     HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV)     HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the     potential restoration of cancer immunosurveillance by this regimen.      Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of     taxane-based chemotherapy in SCCA patients.   "
67452|NCT02402829|"     The purpose of this research study is to see if factor levels and inhibitor levels in     Hemophilia A and B subjects are accurate when they are drawn from a central venous line (CVL)     instead of from a peripheral stick.   "
67453|NCT02402816|"     The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in     the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD     implant.   "
67649|NCT02400242|"     This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to     determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor     activity of ACY-241 for oral administration as monotherapy and in combination therapy with     orally administered pomalidomide and low-dose dexamethasone in eligible patients with     relapsed or relapsed-and-refractory multiple myeloma (MM).   "
67454|NCT02402803|"     Cardiovascular disease (CVD) is the number one cause of mortality for men and women in the     United States. Dyslipidemia, particularly a high low-density-lipoprotein cholesterol (LDL-C)     level, is a well-established cardiovascular risk factor and the current American Heart     Association guideline for CVD risk assessment recommends a lipid panel to be checked. In     addition, guidelines recommend statin therapy in all patients with clinical atherosclerotic     CVD, all patients with LDL-C = 190 mg/dL, patients age 40-75 years with diabetes and LDL-C     70-189 mg/dL, and patients with an estimated 10-year atherosclerotic CVD risk = 7.5%. For all     of these patients, a fasting lipid panel should be drawn prior to statin initiation as well     as during follow-up to assess medication and lifestyle adherence. These fasting lipid panels     are obtained via conventional phlebotomy via venopuncture in an office-based or hospital     laboratory setting. However, research protein quantitation with mass spectrometry and     enzyme-linked immunosorbent assay (ELISA) are technologies that allow for sensitive     quantitation of protein biomarkers and targets, including lipoproteins. Most importantly,     multiple reaction monitoring (MRM) mass spectrometry is able to assess samples from a dried     blood spot (DBS), whose advantages include minimal volume requirements, ease of sample     attainment by finger stick with minimal training required, ease of transport, and sample     stability.      The purpose of the proposed analysis is to 1) measure changes in CVD biomarkers before and     after initiation of statin therapy and 2) compare lipid measurements by conventional     phlebotomy blood samples to research protein quantitation measurements in DBS and plasma.   "
67455|NCT02402764|"     The main purpose of this study is to see whether the combination of selinexor (KPT-330) can     help people with triple negative breast cancer (TNBC). Researchers also want to study the     safety and tolerability of Selinexor in TNBC patients.   "
67456|NCT02402751|"     The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained     funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital     in France (only two 7T MRI in France) and therefore a unique opportunity to develop new     diagnostic approaches.      The purpose of this study is to develop, implement and validate new MRI quantitative     parameters derived from ultra high field MRI in order to characterize non-invasively with an     unprecedented resolution and sensitivity, anatomy as well as certain physiological,     hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart     in healthy subjects   "
67457|NCT02402738|"     Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness. The perinatal     period dramatically increases risk for mood episodes in women with BD, but pregnancy     complicates pharmacologic treatment decisions and efficacy. This study will be the first to     systematically develop and pilot test an adjunctive psychosocial intervention to assist in     treatment of BD during the high-risk perinatal period.   "
67458|NCT02402725|"     This is a phase II, open label, single-center study of ultra-high dose dexamethasone     administered intravenously and orally as monotherapy for the treatment of relapsed multiple     myeloma. Dexamethasone has known anti-myeloma activity, and has been studied extensively both     alone, and in combination with other agents, in the treatment of multiple myeloma.      This study implements an optimal 2-stage design. In Stage 1, 10 patients will be enrolled.     Each patient will receive 100mg of intravenous dexamethasone once on Day 1, immediately     followed by 24mg of oral (PO) dexamethasone every 6 hours for 3 days (Days 1-3) in a 28-day     cycle. After 4 cycles, the patients will be evaluated for efficacy and safety. If 2 or more     of the original 10 patients experience a CR, very good partial response (VGPR), or PR, an     additional 20 patients will be enrolled in Stage 2. The enrollment for Stage 2 will occur     after the completion of 4 cycles of ultra-high dose dexamethasone. If <2 patients experience     a CR, VGPR, or PR, the study will be discontinued. Patients will be treated until     progression, intolerable side effects, or death.      The purpose of the proposed phase II study is to determine the overall response rate,     progression free survival, and tolerability of ultra-high dose dexamethasone.   "
67459|NCT02402712|"     This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and     tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients     with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to     receive study medication until disease progression, unacceptable toxicity, withdrawal of     consent, death, or predefined study end, whichever occurs first. The anticipated time on     study treatment is approximately 24 months. The target sample size is 400.   "
67460|NCT02402699|"     This protocol is being conducted to comply with the direct request from the Taiwan Food and     Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients     with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on     antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable,     recurrent or metastatic) Melanoma.   "
67461|NCT02402686|"     The aim of this non-interventional study in Hungarian participants is to gather real life     data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about     pattern of usage of tocilizumab monotherapy in RA disease management.   "
67462|NCT02402673|"     Problem: Adolescent patellofemoral pain (PFP) is a major problem worldwide and affects 7% of     adolescents. Adolescents with PFP have long-lasting severe pain and low quality of life.     Current treatment is ineffective for more than 60% and new treatment approaches are needed.      Solution: A novel multidimensional diagnostic approach combining imaging, physical activity     level and pain sensitisation in adolescents with PFP. This approach will enable the     identification of adolescents with PFP who benefits from a new treatment strategy using     activity modification to reduce loading of the patellofemoral joint and graded exercises to     improve loading capacity.   "
67463|NCT02402660|"     The purpose of this study is to determine the long term safety and tolerability of ALK-001     (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of     Stargardt disease in patients between the ages of 12 and 60 years old.      Funding Source - FDA OOPD   "
67464|NCT02402647|"     This project will utilize a novel behavioral intervention for hoarding disorder that takes     into account age and neurocognitive factors. The goal of this project is to gain knowledge on     how treatment components may or may not work for Veterans with hoarding disorder. Further,     the investigators hope to increase understanding of functional and long term outcomes in     response to hoarding treatment.   "
67465|NCT02402634|"     Mechanical ventilatory lung care is essential for postoperative care in liver transplantation     recipients, for such patients are under massive fluid challenge and hemodynamic alterations     perioperatively. Some of the recipients experience difficulty in weaning off from the     mechanical ventilator due to various causes. This study is to investigate the relationship     between the inflammatory gene polymorphism, known for acute lung injury, and the duration of     mechanical ventilatory care for such liver transplantation recipients.   "
67466|NCT02402621|"     Comparing postoperative analgesics requirements and complications between conventional and     model-based infusion strategy of intravenous patient-controlled analgesia in patients who     undergoing robot assisted laparoscopic radical prostatectomy      Group A: conventional intravenous patient-controlled analgesia, Group B: model-based infusion     strategy of intravenous patient-controlled analgesia   "
67467|NCT02402608|"     This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the     hypothesis that nutritional supplementation with whey protein, essential amino acids and     vitamin D concurrent with regular, controlled physical activity would increase muscle mass,     strength, physical functional, quality of life, and decrease the risk of malnutrition and     inflammation in sarcopenic elderly.   "
67468|NCT02402595|"     The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor,     itraconazole, on the steady-state PK of AVP-923 and AVP-786.   "
67469|NCT02402582|"     Implementing the Family-centered Empowerment Model (FCEM) as a new Cardiac Rehabilitation     program for Myocardial Infarction patients with four-stage including perceived threat with     group discussion method, self-efficacy with problem solving method, self-esteem with     educational partnership and outcome and process evaluations   "
67470|NCT02402569|"     This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a     multi-electrodes set.   "
67471|NCT02402556|"     The purpose of the Mother Child Education Program (MOCEP)—a group-based early childhood     development parenting education program—is to provide school-readiness and parenting skills     to mothers of young children who do not have access to preschool education services. The     MOCEP intervention also provides a setting in which caregivers can model pro-social behaviors     and practice conflict resolution techniques directly with young children.   "
67472|NCT02402543|"     The perianal region is the region around the anus. Administering a pain medication before a     surgery starts is called preemptive analgesia. In some studies, this technique has been shown     to be an effective way to reduce the pain that a patient experiences in the post-operative     timeframe to a greater extent than would be expected simply from the pain medications alone.     One theory of why this occurs suggests that the preemptive analgesia desensitizes brain and     nerves to pain, thereby decreasing the response to painful stimuli, like surgery when they     occur. This leads to a decrease in the amount of narcotic pain medication required after the     procedure, which leads to less side effects and a quicker return to normal functioning. As     perianal surgeries do not usually include a long stay in the hospital, controlling     post-procedure pain is a priority.      The use of preemptive analgesia is in other types of surgeries, such as orthopedics, is well     established, but as the perianal region has not been well studied, its use is not the     standard of care. This type of analgesia uses a combination of medications that are already     in use for post-operative and non-operative pain control and administers them orally prior to     the patient undergoing general anesthesia. The side effects of the medications are the same     as if they had been given after surgery or for non-surgical pain.      The concept of preemptive analgesia is established in other types of surgeries and it has     solid basic science to support its use. The purpose of this randomized, double-blind, placebo     controlled study is to determine if patients undergoing perianal surgeries could benefit from     preemptive pain control. The primary outcome will be whether patients experience less     post-operative pain. Patient post-operative consumption and latency until use of narcotic     pain medication will be the secondary outcomes. The investigators believe that the patients     receiving pain medications before their operation will require less pain medication after     surgery, with minimal increased risk to the patient.   "
67473|NCT02402530|"     This clinical trial is being conducted to demonstrate the efficacy of neridronic acid in the     treatment of pain associated with complex regional pain syndrome type I (CRPS-I).      The trial is divided into 3 periods: a 60-day enrollment period, a 12-week trial period, and     an extended follow-up period with visits at Month 6, Month 9, and Month 12. The extended     follow-up period will be terminated for all participants after the last participant enrolled     completes their Month 6 visit (Visit 9). The double-blind will be maintained throughout the     12-week trial period and extended follow-up period.   "
67474|NCT02402517|"     The objectives are to test the acute effects of different extruded pulse snacks on: 1)     aerobic endurance and substrate oxidation during exercise 2) response of blood glucose,     insulin and appetite on an aerobic exercise session, and 3) food intake two hours following     the exercise session. The investigators hypothesize that consumption of food products     containing pulse ingredients 60 minutes before exercise will increase aerobic endurance     (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient),     and a reduction in lactate production during compared to the same exercise session following     the ingestion of a non-pulse food. The investigators also hypothesize that consumption of     extruded pulse snacks will lead to lower blood glucose, insulin, appetite and food intake,     suggesting lower calorie compensation, following a 60-minute aerobic exercise session     compared to the same exercise session following the ingestion of a non-pulse food.   "
67475|NCT02402504|"     The objectives are to test the acute effects of different extruded pulse snacks on: 1)     post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours     following consumption of pulse products.      The investigators hypothesize that snack products containing pulse ingredients will lead to     lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack     products.   "
67476|NCT02402491|"     Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis     (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months     of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all     patients continue receiving aspirin indefinitely. The primary efficacy end points of this     study are the incidence of a composite end point including all cause deaths, myocardial     infarction, the incidence of Academic Research Consortium defined definite or probable stent     thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of     GUSTO moderate or severe bleeding.   "
67493|NCT02402270|"     The purpose of this study is to learn about a new bowel preparation that uses food to clean     the colon.      In order to learn about this new food preparation, some people in this study will get the     food preparation, and others will get the standard liquid bowel preparation.      Patients will be randomized (like flipping a coin) to one of five groups:      Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B     Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains     bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY   "
67477|NCT02402478|"     The purpose of this study is to advance research through collaboration, 4C was established in     the United Kingdom (UK) in 2009 as a resource in which deoxyribonucleic acid (DNA) and     biomarker samples were obtained at time of presentation with chest pain linked to detailed     phenotypic data obtained from electronic health records and participant self-completed     questionnaires. The investigators sought to explore and assess the current potential of     setting up a comparable consented research platform by collecting DNA samples and to quantify     the extent to which diverse NHS hospital information systems are accessible for extracting     secondary care data (structured and unstructured) for research purposes at scale.   "
67478|NCT02402465|"     Dymista, a combined product containing the antihistamine azelastine and the intranasal     steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and     azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of     efficacy not only occurs at the initiation of treatment, but persists for its duration. The     mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on     examining the effects of Dymista on the dynamics of the allergic response in man using nasal     provocation with antigen. The investigators will study the relationship between symptoms,     physiology, cells and mediators.   "
67479|NCT02402452|"     This study will evaluate the pharmacokinetics, safety, and tolerability of GS-9857 in adults     with severe renal impairment and matched healthy control adults.   "
67480|NCT02402439|"     The goal of this trial is to gain initial clinical experience regarding the safety and     efficacy of treating type I diabetes in people who have received a kidney transplant by     transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa).     A total of 6 patients will be enrolled in the study and followed for a period of up to 3     years after the last islet transplant.   "
67481|NCT02402426|"     The overall goal of this project is to identify, assess and longitudinally monitor subjects     who are interested in participating in brain research. Participants will enroll through the     website, BrainHealthRegistry.org, and provide informed consent prior to any study activities.     The website will collect a variety of information, including participants' overall health,     memory complaints, family history of dementia and Alzheimer's disease (AD), mood status,     sleep, diet, and exercise—all through self-reported online questionnaires. Participants will     also be ask to take online cognitive tests, and to return to the website at regular     intervals, to complete follow-up questionnaires and neuropsychological assessments. Everyone     over the age of 18 is welcome to participate. To join the Brain Health Registry, please visit     www.BrainHealthRegistry.org.   "
67482|NCT02402413|"     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in     women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is     characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual     cycles, hyperandrogenism, and polycystic ovarian morphology.      An important ultrasound parameter is the ratio stroma/ovary, the ratio of the volume,     evaluated in two-dimensional ultrasound, of the stroma, that secrete androgen, and the ovary.     It has been shown that when this ratio is higher than a third the levels of circulating     androgens and high. Aim of the present study is to assess whether this ratio, determined with     three-dimensional ultrasound, is correlated to the increase of androgens.   "
67483|NCT02402400|"     Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in     ACS/non ST-elevation Myocardial Infarction (NSTEMI) patients on platelet reactivity.   "
67484|NCT02402387|"     The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of     the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions.     Moreover, the adequacy of ventilation will be assessed in the different head and neck     positions.   "
67485|NCT02402374|"     Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the     treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a     larger randomized, placebo-controlled clinical trial will be useful to determine whether     platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).   "
67486|NCT02402361|"     Understanding risk factors and determinants for neuropathic pain.   "
67487|NCT02402348|"     The study researchers want to look at the overall effects that Metformin may have on the     tumor characteristics of Head and Neck cancer cells as well as the interactions that     Metformin has on the growth or death of tumor cells.   "
67488|NCT02402335|"     The purpose of this study is to examine whether there are relations between different types     of pain in groups of patients with different diagnoses of degenerative diseases of the spinal     column and their related surgeries.   "
67489|NCT02402322|"     The aim of this study was to compare two ways of administrating the complementary     psychological support (scheduled vs. non-scheduled) in an online self-help program for panic     disorder. In order to do so, the investigators studied: a) If there were differences in the     intensity and frequency of the symptoms of panic disorder. b) If there were differences in     the therapeutic adherence between the subjects receiving both kinds of complementary support.     c) If the more time spent by a psychologist in therapeutic interventions produced the best     results of therapeutic adherence / symptom improvement.      Seventy seven subjects followed the online self-help program for 8 weeks; 27 subjects had the     support of a therapist via phone when they required it, 25 subjects had the support of a     therapist weekly and 25 subjects were in the waiting list as a control group.   "
67490|NCT02402309|"     This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study     designed to evaluate the safety, PK, and exploratory activity of topically-applied NS2     dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to     Sjögren- Larsson Syndrome (SLS).      NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby     diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated     with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.   "
67491|NCT02402296|"     combining the non-surgical therapy with a well-tolerated substance that can stimulate     protective immune responses like B-glucan, might effectively mount resolution pathways     contributing to resolving of the chronic lesion observed in aggressive forms of periodontal     disease.   "
67494|NCT02402257|"     The investigators previously successfully implemented a central venous catheter (CVC)     simulation-based mastery learning (SBML) curriculum at Northwestern University. As a result,     trainee skill improved, complications, including central line associated bloodstream     infections (CLABSIs) decreased and the curriculum was proven cost-effective. Therefore the     Veterans Administration Medical Centers (VAMC) decided to implement this training at some of     their sites as a quality improvement project. The investigators will train faculty at these     locations to implement the same curriculum at their individual sites. Outcome data will be     collected to evaluate the outcomes of the quality improvement (QI) project (complications,     infections, skills).   "
67495|NCT02402244|"     This research trial studies the Project: Every Child for younger patients with cancer.     Gathering health information over time from younger patients with cancer may help doctors     find better methods of treatment and on-going care.   "
67496|NCT02402231|"     Severe peanut allergy is different from other allergic reactions because it can lead to fatal     reactions and is an invisible disability. There is no cure today. The purpose of this study     is to treat children and adolescents with severe peanut allergy with oral immunotherapy with     peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and     thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell     stimulation (CD-sens).   "
67497|NCT02402218|"     This study is being done to compare three ways to give the study drug Harvoni (a tablet that     includes two drugs also called Sofosbuvir/Ledipasvir) for 12 weeks in people who are infected     with both Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Subjects will     receive this drug as part of the study. Subjects will be randomized into one of three     treatment groups:        1. Usual care in the clinic. This treatment group will receive the standard of care for HCV          treatment from their health care team.        2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational          strategy in which participants assigned to this group will be asked to interact with a          peer-mentor who is someone who has been cured of their HCV infection.        3. Usual care plus incentives. In addition to the usual care, this is an investigational          strategy in which participants assigned to this group will be given incentives after          completing certain treatment goals during the course of the study.      HCV treatment with Harvoni is considered the standard of care for HCV and is recommended by     experts in liver disease and infectious diseases.   "
67498|NCT02402205|"     Adjudicated youth often have traumatic stress responses but rarely receive treatment for     these problems. This study is a randomized controlled trial to evaluate two alternative     implementation strategies for providing an evidence-based trauma treatment, Trauma-Focused     Cognitive Behavioral Therapy (TF-CBT), to therapist who treat adjudicated youth in 18     residential treatment facilities (RTF) in New Hampshire, Vermont, and Connecticut: 1)     web-based TF-CBT implementation strategy (W), consisting on only web-based training and     consultation; versus 2) W plus live TF-CBT implementation strategy, consisting of W plus     face-to face training and phone consultation with TF-CBT experts (W+L).   "
67499|NCT02402192|"     The study is proposed to determine the effect of three types of gonadotropins that are     currently used in protocols of controlled ovarian stimulation in women undergoing in vitro     fertilization techniques on the kinetics of embryonic development.   "
67500|NCT02402179|"     Our objective is to determine the metabolic availability of Tryptophan in white maize using     the indicator amino acid oxidation (IAAO) technique in adult men.   "
67501|NCT02402166|"     The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and     efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with     ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD     population.   "
67503|NCT02402140|"     Primary end-point      The primary end-point was the influence of pharmaceutical intervention in tacrolimus     intra-subject variability during the first 3 months after kidney transplant. Coefficients of     variation were calculated from the average of dose-corrected tacrolimus blood     concentration(CV= Standard Deviation (SD) x 100/mean) of study visits day 10, 14, 21, 30, 60     and 90 post kidney transplant.      Secondary end-points        1. Secondary outcomes included evaluate percentage of patients who achieved target levels          of tacrolimus in day study visits 7, 10, 14, 21, 28, 60 e 90 days after kidney          transplant;        2. Tacrolimus bioavailability profile during the period of 3 months,characterized by mean          and standard deviation (SD) of dose corrected tacrolimus blood concentration(ng/ml/mg);        3. Assess patient adherence through validated questionnaire Portuguese version of Basel          Scale Adherence Rating Immunosuppressive Drugs (BAASIS) scale. It consists of a          four-item questionnaire measuring nonadherence to immunosuppressives over the past four          weeks. This questionnaire assesses omission of single doses or successive doses, timing          deviations >2h and dose reductions. Responses are given on a six-point scale: never,          once per month, every second week, every week, more than once per week and every day.          Patients that answer different from never in any of the four questions are considered          as nonadherent;        4. We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);        5. We evaluated Incidence of Infections;        6. We evaluated Treated acute rejection episodes;        7. We evaluated Death cases;        8. We evaluated Graft loss cases;        9. We evaluated Discontinuation of immunosuppressive treatment;       10. We evaluated Hospital readmissions.      Study Design      This was a single-center, prospective, randomized and controlled study to evaluate the     influence of pharmaceutical intervention in tacrolimus intra-subject variability during the     first 3 months after transplantation. The authors designed the protocol, acquired and     maintained the data, and conducted the statistical analysis. The protocol was approved by an     independent ethics committee. All subjects signed a written informed consent before     enrollment and the study was conducted according to good clinical practices and declaration     of Helsinki. This study was conducted at Hospital do Rim between February 2014 and December     2014, 128 randomized and were followed for 3 months after transplantation.   "
67504|NCT02402127|"     The purpose of this study is to measure the coefficient of friction of three silicone     hydrogel, daily disposable contact lenses after 16 hours of wear.   "
67523|NCT02401880|"     The primary aim of this exploratory mechanistic study is to investigate the effects of     Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.      This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to     placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell     function, as well as several markers of metabolic control.   "
67524|NCT02401867|"     The purpose of this study is to assess the acceptability and effectiveness of utilizing     vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for     HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections (STIs)     among sexually active female-to-male (FTM) transgender adults.   "
67525|NCT02401854|"     The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial     fibrillation (AF) among elderly patients with hypertension and at least one other risk factor     for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30     to 60 days.   "
67505|NCT02402114|"     Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after     exposure to a dangerous or life-threatening event. It is characterized by persistent fear-     and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt.     These symptoms can interfere significantly with patients' lives and in some cases can be     debilitating. One of the most frequent causes of PTSD is being a victim of a violent,     interpersonal assault.      PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded     too strongly in a patient's long-term memory, remaining too accessible and present to the     patient long after the actual threat has passed. In recent years evidence has emerged that it     may be possible to prevent PTSD by moderating the process of memory consolidation that occurs     in the hours and days after a traumatic event.      Early research has suggested that enhancing the body's natural cortisol response to a     stressful event may be a safe and effective way of moderating the process of memory     consolidation and promoting adaptive, non-pathological memory encoding. In particular, the     administration of hydrocortisone, a safe and widely used drug that mimics the body's own     cortisol hormone, appears to reduce the risk of developing PTSD in patients who have     sustained a traumatic event. However, this research is still in relatively early stages, and     requires larger trials to confirm its efficacy. In addition, the research thus far has not     adequately targeted assault victims, whom Investigator feel are some of the patients most     likely to benefit from such an approach.      Investigators propose a prospective, placebo-controlled, double-blinded trial of     administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the     Einstein Medical Center Philadelphia Emergency Department to determine if this approach has     efficacy in preventing PTSD. This study is designed as a pilot study, with the hopes that the     data gathered in it can be used to design a larger and more robust trial in the future.   "
67506|NCT02402101|"     Transcranial direct current stimulation (tDCS) is a technique that is emerging as a     prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal     tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement     of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers     from limitations, especially regarding the strength and the duration of therapeutic effects.     Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge     about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings     through commercial apparatus and tutorials to make a do-it-yourself device delivering tDCS     now available on the Internet. This private use worries neuroscientists and health     authorities. Even if the general impression is that, in controlled conditions, tDCS is safe     with only mild and transient adverse effects, whether and how tDCS could be used for     enhancing cognition in healthy subjects are needed to investigate in more detail. The     investigators believe that a better understanding of some neurobiological effects of tDCS is     crucial to further tailor tDCS for experimental and therapeutic applications and to define     recommendations for a private use.      As the cortex is densely connected with basal ganglia areas, including dopaminergic areas,     tDCS is probably not only capable to target cortical but also subcortical structures remote     from the stimulation sites. Some studies suggest that cortical stimulation by other     approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased     dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been     investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC     stimulation by tDCS on dopaminergic transmission is still unknown.      The aim of this project is to reveal the online impact of a single-session of tDCS applied     bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by     PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.   "
67507|NCT02402088|"     The purpose of this study is to examine the role of stress in food craving and food     consumption in obesity. Using experimentally validated guided imagery procedure, the     investigators propose to examine the stress response using subjective, physiological and     neurobiological measurements.   "
67508|NCT02402075|"     During neurosurgical resection of brain tumors within brain areas for motor control, it is     important to monitor motor function. For this muscle motor evoked potentials are used. Those     are elicited by transcranial and direct cortical stimulation. Motor responses are recorded     from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used,     but additionally motor activity is recorded from the spinal cord. This is called spinal motor     evoked potentials. It is known that the relation between spinal and muscle motor evoked     potentials helps to extent the resection of spinal cord tumors. This study implements the     spinal motor evoked potential into brain tumor surgery and analyses the relationship between     spinal and muscle motor evoked potentials. With this, detection of injury to the brain area     for motor control might be discovered earlier and thus tumor resection can be performed     safely.   "
67509|NCT02402062|"     The purpose of this study is to determine the safety and the efficacy of the combination of     the drugs TH-302 and sunitinib in metastatic neuroendocrine tumours.   "
67510|NCT02402049|"     The proposed study will focus on premenstrual syndrome (PMS) symptom alleviation for women     diagnosed as suffering from the syndrome with the DRSP questionnaire.      The women will be treated with Homeopatic remedies. The improvement of PMS symptoms will be     evaluated using the Daily Record of Severity of Problems questionnaire (DRSP). The     questionnaire will be completed daily by women for 2 months prior to receiving the treatment     and for 3 months following treatment with a single dose of the homeopathy treatment.   "
67512|NCT02402023|"     The purpose of this clinical trial is to determine the feasibility and efficacy of an     intervention designed to increase rates of tobacco abstinence for cancer patients before     their cancer surgery.   "
67513|NCT02402010|"     As a practice that incorporates elements of physical exercise, controlled breathing, and     meditation, yoga is gaining increasing acceptance as an adjunctive intervention for many     psychiatric disorders. Although yoga has been frequently recommended as a symptom management     strategy for bipolar disorder (BD), and although there is some preliminary evidence that yoga     may be helpful in alleviating depressive symptoms, there are no systematic studies on the     benefits - and potential risks - of the practice of yoga in BD. The primary aim of the     proposed study is to develop and evaluate the feasibility, acceptability, and safety of an     adjunctive yoga intervention for bipolar depression in a 10 week pilot randomized controlled     trial (RCT).   "
67514|NCT02401997|"     To determine the ideal sexual abstinence time for producing high quality sperm   "
67526|NCT02401841|"     It is a observational prospective study. The aim of this study is to compare neostigmine vs     sugammadex in the resolution of neuro-muscular blockade in great obese patients.   "
67660|NCT02400099|"     Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more     effective than a control low calorie diet in improving the metabolic and histologic     abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric     surgery.   "
67635|NCT02400424|"     The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy     after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma     (NSCLC) with peripheral primary tumor.      Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy     after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III     NSCLC having a peripheral primary tumor.      The number of patients required in this multicenter prospective study is 70.      This is a prospective, multicenter, non comparative and non randomized study.   "
67515|NCT02401984|"     Mental disorders are common in youth and adults. Symptoms of mental are aggravated by     unemployment. Compared to the working population, the unemployed have higher rates of poor     health, a tendency toward negative emotionality and depression, show symptoms of exhaustion     more frequently, and experience disturbed sleep or have a sleep disorder. It can be     reasonably expected that unemployment in adolescents and young adults causes the same     symptoms and behaviors as in adults. In those youth with a mental disorder, particularly an     untreated one, the transfer from school to the employment market can be hindered. At the same     time, the investigators notice an increase in early disability pensions due to mental health     issues among adolescents. Thus, the early recognition and treatment of mental disorders and     psychological strain is crucial in promoting the employment of young people and supporting     their connection to the employment market.With this project the investigators want to     implement an early intervention and reach out to unemployed youth. The investigators     identified the period between graduation and first employment as the ideal moment of     intervention, because this time period is a critical period in which young people are exposed     to increasing personal challenges. Conducting an intervention before a psychological stress     transforms into a mental disorder, can prevent harm and suffering to the afflicted person. In     addition, early intervention could help prevent the need to enroll in the early disability     pension program.   "
67516|NCT02401971|"     Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal     toxicities when the CPT-11 is administered in combination with thalidomide in patients with     diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy     and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also     manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide     to explain the previously described gastrointestinal toxicity reduction.   "
67517|NCT02401958|"     ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and     progressive disease that can lead to joint destruction and important functional disability.     Chronic inflammation, with a substantial increase in the amount of pro-inflammatory cytokines     in synovial joint, is one of the biggest challenges in controlling RA. Resistance exercise     has been recognized for positively modulate inflammation in healthy subjects. Objective: To     evaluate the effect of an acute bout of resistance exercise on serum concentrations of tumor     necrosis factor alpha (TNF-α), interleukin 1 receptor antagonist(IL-1ra), interleukin 1 beta     (IL-1β), C reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), and     cartilage oligomeric matrix protein (COMP) in postmenopausal women with RA and women without     the disease. Methods: 17 volunteers with RA and 17 without the disease, with a mean age of     54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of     one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises     performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples     were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24     hours after the exercise session. Serum glucose concentrations prior to exercise were also     measured. The investigators used the Student's't test, the model of analysis of variance with     repeated measures and Bonferroni method of multiple comparisons to analyze the data, being     considered statistically significant levels of p <0.05.   "
67518|NCT02401945|"     The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT)     administration of DE-120 in subjects with treatment-naive active subfoveal choroidal     neovascularization (CNV) secondary to age-related macular degeneration (AMD).   "
67519|NCT02401932|"     Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.   "
67520|NCT02401919|"     COMMUNICATION - Feasibility and effectiveness 'Tell-us Cards' in hospital patients        -  Objective - To investigate the feasibility and effectiveness of 'Tell-us Cards' on          patient participation in basic care in hospital settings.        -  Design - Cluster randomised controlled early trial design (Phase 2B, MRC Framework).          Patients of two surgical and two medical wards (n=140) will be included in this study.          Before and after the introduction of the intervention, assessments will take place in          patients and nurses at these wards.        -  Intervention - The 'Tell-us card' is a tool to elicit patients preferences and needs in          basic care. Patients are invited to write down their specific questions and concerns.          The cards are handed out to patients admitted to the hospital (daily). Patients and          informal caregivers are invited to use the cards to state their preferences. Nurses are          instructed to use the cards as a tool in their dialogue with the patient in making care          plans, during ward rounds or for discharge information sessions.        -  Comparison - Usual care        -  Primary outcome - Patient perception of participation in care (Individualized Care Scale          (ICS)        -  Secondary - Use and content of the 'Tell-us Cards' actions taken by nurses as a          consequence of what patients 'tell them' by means of the 'Tell-us Cards', Quality from          the Patients' perspective (QPP), EQ-5D, and CQ satisfaction with communication & care in          general   "
67521|NCT02401906|"     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid     structures or vascular structures. These masses can be tumors, benign or malignant, or     pseudotumor, mainly represented by specific or non-specific orbital inflammation.      Pathology is of considerable importance for the diagnosis and the treatment of those masses.     However, biopsy or surgical resection of the orbital masses is sometimes difficult and     dangerous outside expert centers.      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,     thus avoid in some cases a biopsy, would be a major contribution for the patients.      The MRI assessment performed routinely in a patient with an orbital mass includes     morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This     exploration requires, regardless of the performed research, a contrast agent injection (0.1     mg / kg weight of Gadobutrol®).      In this research protocol, during the injection of the contrast agent performed during the     MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated     acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition     will be preceded by two short series for calibration. The post treatment will include     parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more     regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being     the reference. It will also be added a magnetic susceptibility EPI sequence type. All the     qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in     susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent     diffusion coefficient) parameters will be collected.      The result of the pathological exam of the biopsy or of the surgical specimen, which is the     gold-standard, will be collected.   "
67522|NCT02401893|"     Little is known about factors associated with maintenance of hemagglutinin inhibition (HAI)     antibodies after influenza vaccination in older adults so the investigators enrolled adults     ≥50 years.   "
67527|NCT02401828|"     48-week open label randomized phase IV investigator initiated intervention study. The purpose     of this study is to evaluate whether HIV-1 suppression can be maintained by DTG monotherapy     in HIV-1 infected, virologically suppressed patients on cART.      104 adults fulfilling the in and exclusion criteria and on stable cART will be randomized     over 2 investigational arms.      The first arm will contain the direct switch population. This population will switch directly     from stable cART to Dolutegravir mono-therapy on baseline visit.      The second arm will contain the delayed-switch population. This group will switch from stable     cART to Dolutegravir monotherapy 24 weeks after baseline visit.      The main goal is to investigate if Dolutegravir mono-therapy could be non-inferior to cART in     virological suppressed HIV-1 infected adults.      If a interim analysis (performed when 40 patients on dolutegravir monotherapy have passed     week 12) shows that it is safe to continue the study, an additional 30 patients will be     included on top of the 104 patients needed for the primary endpoint analysis. In contrast to     the primary endpoint population, these additional 30 patients will have a CD4 nadir <200 but     a CD4 >350 at the time of the screening visit. Besides that, these 30 patients will have to     fulfill all other in and exclusion criteria of the primary endpoint population (specifically     a viral load never >100.000). These 30 patients are part of a pilot study looking at the     possibility to broaden the eligible population in a future larger randomized clinical trial.   "
67528|NCT02401815|"     The goal of this clinical research study is to learn how PLX9486 may affect cancer cells with     certain mutations in the KIT gene, specifically in patients with types of advanced solid     tumors including Gastrointestinal Stromal Tumor (GIST).      PLX9486 is designed to block KIT gene mutations. These mutations can cause cancer and cancer     cell growth. By blocking these mutations, the drug may kill the cancer cells with the     mutation and/or stop the tumor from growing. By combining PLX9486 with PLX3397 and PLX9486     with Sunitinib, the investigators hope to block most gene mutations in KIT.   "
67529|NCT02401802|"     This trial will compare the efficacy of 2 different sets of dietary recommendations to be     followed before colon cleansing for colorectal cancer screening colonoscopy.   "
67530|NCT02401789|"     The objective of the present study is to evaluate if loss of multiple adjacent teeth will     cause proportionally greater tissue diminution than the loss of single teeth the possibility     of counteracting unfavourable ridge modeling after multiple tooth extractions by placing     implants in the fresh extraction sites soft tissue alterations at implants and adjacent teeth   "
67531|NCT02401776|"     -  The primary objective of this study is to assess the effect of an energy drink on          ventricular repolarization as measured by the interval between the cardiac Q wave and          the cardiac T wave (QT interval)obtained from the body surface ECG.        -  The secondary objective is to assess the effects of an energy drink on heart rate and          blood pressure (hemodynamic effects).      To place the observed changes in context, comparison will be made to a commonly consumed     drink, coffee: Starbuck's K-cup Breakfast Blend.   "
67532|NCT02401763|"     Nasopharyngeal carcinoma (NPC) is the tenth leading cancers in Taiwan and investigating its     biomarker is important for understanding the mechanism of its pathogenesis.   "
67533|NCT02401750|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3     study to evaluate the efficacy and safety of the administration of multiple doses of     Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus     Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first     metatarsal bunionectomy with osteotomy and internal fixation.   "
67534|NCT02401737|"     This Phase 1b trial will assess the dose-related safety and PK profile of different doses of     NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV     DNA levels and other virologic efficacy parameters will be assessed.   "
67535|NCT02401724|"     After a stroke affecting the right side of the brain, many patients are affected by spatial     neglect: the damage to the brain causes them to ignore the left side of their surroundings.     At its most extreme they may be unaware that they have a left side, or believe that it is     moving normally when it is in fact paralysed. In milder cases, people may be unable to     recognise touch on the left side if their right side is also being touched, or objects in     their left visual field if something is visible to their right. Neglect alters peoples'     quality of life profoundly, often renders them more dependent on others to undertake basic     activities of daily living, and makes effective rehabilitation much more difficult.      The limited success of current treatment approaches indicates gaps in understanding of the     underlying mechanisms of neglect and its recovery. Recent data suggest that the problems in     responding to the left side are a result of an imbalance of activity in those parts of the     brain responsible for deciding which side to pay attention to. It might therefore be possible     to help people with neglect by rebalancing the brain either by increasing activity in the     damaged side, or alternatively by reducing activity in the undamaged side. In this pilot     study, the investigators will test whether they can help by doing the second of these things.      The investigators propose to conduct a pilot clinical trial to explore whether using electric     currents to temporarily modify the activity of specific areas of the intact side of the     brain, influences recovery from neglect, when used either alone, or in combination with a     training method that has previously appeared promising as a treatment. Brain activity will be     modified using a technique called transcranial direct current stimulation (tDCS), in which     small electric currents are applied to the scalp with a wire covered in damp cotton pads.     This will be done over the specific parts of the brain that are responsible for focusing     attention to one side.      The investigators will compare the clinical outcomes of four interventions (1: behavioural,     2: tDCS, 3: a combination of both and 4: control).      The investigators hope that these studies will advance their understanding of what treatments     may help people with neglect, and how they might work.   "
67536|NCT02401711|"     The purpose of this study is to compare the effectiveness of two methods, safety curriculum     in addition to online training alone, for teaching patient safety to surgery residents.     Despite multiple studies evaluating educational safety curricula, the best methods for     teaching residents about patient safety is unknown. It is hypothesized that empowering     surgery residents to actively engage in behaviors to increase patient safety may lead to a     higher quality perioperative care and communication.   "
67579|NCT02401152|"     The objective of this study is to investigate whether two newly developed sports drink will     affect gastric distress (GD) and running performance (RP) compared to an iso-caloric control     drink both in a short and longer distance run. Furthermore, the effect of the newly developed     sports drinks on gastric emptying will be investigated.      The study will consist of 3 parts. Firstly, a randomized cross-over design is used for the     short distance run and the effects on GD and RP. Secondly, a parallel design is used to study     the effects of the drinks on GD and RP during a longer distance run. Thirdly, the gastric     emptying tests will be performed in a randomized cross-over design. Participants will be     asked to fill in questionnaire on the gastric distress they experience. 40 participants will     be enrolled to participate in part 1 and part 2. 10 out of 40 will participate in part 3 of     the study.   "
67537|NCT02401698|"     The past 10 years of research in post stroke patients have shown certain types of     rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation     (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain     activity). Recent research suggests that TMS can be used for both prognosis (determining     future function) and to determine what type of rehabilitation therapy will work best after     stroke. The purposes of this research study are to: 1) determine changes in cerebellar     activity after motor cortical stroke 2) compare changes in recovery of motor function with     changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to     predict functional outcome after stroke. The primary hypotheses are: 1) functional recovery     will be correlated with TMS changes (as measure of motor threshold (MT), intracortical     inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and     recruitment curves; 2) baseline TMS will predict future functional outcomes.   "
67538|NCT02401685|"     POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.      Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to     assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary     treatment, in terms of axillary recurrence within 5 years.      Stratification: Institution, Age (<50, ≥50), Breast-conserving surgery (BCS) or mastectomy,     Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2),     Intra-operative sentinel assessment using OSNA (yes, no).      Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus     axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).      Sample Size: 1900 participants      Follow-up: Participants will be followed up for 5 years.      Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy     and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy.     Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant     therapy alone.   "
67539|NCT02401672|"     Cigarette smoking remains a significant public health concern. A magnetic field applied to     the outside of the skull can produce electrical activity in the brain without significant     pain or the need for anesthesia. Sessions of magnetic stimulation or superficial stimulation     that does not reach the brain will be used to determine if magnetic stimulation can reduce     cue-induced craving and cigarettes consumption in adult nicotine-dependent cigarette smokers.     This project may lead to a new therapy for smoking cessation.   "
67540|NCT02401659|"     Valiosa is a national, multicenter and prospective post market study. The objectives of the     study are to generate and validate an instrument to evaluate patient and clinician's     satisfaction with remote monitoring and to create awareness of the importance of remote     monitoring among patients, physicians and decision makers.   "
67541|NCT02401646|"     The aim of this study is to identify the effect of Polygoni Multiflori Radix complex extract     on memory improvement using Rey-Kim scale for healthy people.   "
67542|NCT02401633|"     Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of mortality in the     industrialized world. Bystander CPR before arrival of the Emergency Medical Service (EMS) is     a positive predictor of survival. During the last decade, the best form of bystander CPR has     been debated. Chest Compression Only CPR (CO-CPR) has been advocated as a preferable method     in situations where the bystander has no previous knowledge in CPR, both because its believed     to be equally efficient but also a simplified form of CPR that could lead to a higher     incidence of bystander-CPR.      The purpose of this study is to perform av run-in period with focus on safety and feasibility     prior to the launch of a larger randomized trial which has a primary end-point of survival.     This study will compare OHCA with standard CPR (S-CPR; chest compressions and rescue breaths     in a 30:2 fashion) compared to CO-CPR.   "
67543|NCT02401620|"     The purpose of the present study is to assess the measurement properties of a tolerability     questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated     will be robust and will assess the patient's tolerability to the treatment. Patients with     greater tolerability will be more satisfied with their treatment.   "
67544|NCT02401607|"     The Karasek Job Content Questionnaire includes 2 dimensions: the psychological demands at     work, and the latitude decision. The combination of these two characteristics explains the     degree of exposure of a worker to stress. Indeed, a worker is under pressure (job-strain)     when workload is important and autonomy is poor. The Sumer study was conducted in France on     25,000 employees and classified occupations taking into account psychological demands and     latitude decision of occupations. No publication on emergency physicians' responses to     Karasek questionnaire is referenced, even though theirs exposures to burnout is known. A     preliminary study on 19 emergency physicians of the CHU of Clermont-Ferrand illustrates     concretely this extraordinary situation, with the lowest decision latitude and the highest     psychological demands ever recorded. Moreover, there are no data on results at the Karasek     questionnaire under different conditions within the same participant, i.e. responses to the     Karasek questionnaire is supposed similar and reflect a constant perception of work.     Additionally, several biomarkers of stress have been proposed, in particular DHEAS due to its     long half-life of 16 hours. To our knowledge, the relationship between biomarkers of stress     and tension at work with Karasek model has never been studied, like this relations with other     wellness questionnaires. Comparisons between emergency health care workers are also lacking.      Our study proposes to evaluate the perception of emergency medicine with Karasek     questionnaire, and to assess possible changes of its perception and in biological response     between two conditions: after a night shift and on a control day (workday), in emergency     health care workers.   "
67580|NCT02401139|"     This study is a Randomized Controlled Trial, investigating the safety and efficacy of     administration of ketamine as a potential treatment for depression.   "
67581|NCT02401126|"     The main purpose of this study is to determine whether dietary nitrate supplementation via     concentrated beetroot juice improves central and peripheral cardiovascular control and     physical capacity in patients with systolic heart failure.   "
67582|NCT02401113|"     This randomized, placebo-controlled, double-blind study was designed to investigate the     efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function     improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per     day or a placebo for 12 weeks.   "
67754|NCT02398877|"     This study evaluates the association between early trauma, depression and metabolic symptoms.   "
67545|NCT02401594|"     PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind     non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000     UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material     removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic     surgeries for femoral neck and trochanteric fractures, THR, TKR)      Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24     hours. However, only a single pre-randomization dose of LMWH is allowed. After randomization,     patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg once-daily started     6-10 hours provided haemostasis has been established after surgery or 24h hours after LMWH     injection if needed for the intended treatment duration of 2 to 12 weeks based on medical     judgment (according to immobilization). Patients allocated to the comparator arm will receive     enoxaparin once daily for the same intended treatment duration. All patients will have a     30-day observational period after cessation of treatment.   "
67546|NCT02401581|"     Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract     of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to     reduce the risk of hemorrhage known to be associated to the transurethral resection of     prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the     GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce     the length of catheterization to facilitate outpatient surgical management of prostate     adenoma.      In the investigators study, the investigators propose to evaluate the failure rate of an     early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS     in selected patients on general anesthesia or spinal anesthesia. To this end, the     investigators realize a national multicenter prospective study including 300 patients. The     effectiveness of this model of management is defined by absence of a need for     re-catheterization in the post -operative period of 24 hours.   "
67547|NCT02401568|"     Compare various dynamic biomechanical markers (distances and angles) in the wrist during     dynamic CT studies in three groups of patients: Normal subjects, with scapholunate     instability and with other types of wrist instability.   "
67548|NCT02401555|"     The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2     Supplemental Assay, a single-use immunochromatographic assay for the confirmation and     differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1     and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA,     heparin, and sodium citrate).   "
67550|NCT02401529|"     This study aims to evaluate the effect of postoperative systemic rapid onset and short acting     dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy     morbidities. Half of the patients who comply with the inclusion criteria were selected to     receive a single postoperative dose of intravenous dexamethasone followed by oral steroids;     the second group received placebo.   "
67551|NCT02401516|"     ASH has a high prevalence rates and considered one of the major modifiable risk factors for     cardiac vascular diseases (CVD) and brain vascular diseases (BVD) and one of the most     important public health problems. Researches estimated 62% of BVD can be attributed to ASH.     In Brazil, prevalence of hypertension ranged from 21.6% in 2006 to 42.4% in 2011. CVD are     responsible for high frequency of hospitalization, and in 2009, 91,970 hospitalizations due     to CVD cost public treasury more than 165 million reais. ASH neurological pathophysiology     studies has shown that excessive activation of sympathetic autonomic nervous system (SANS)     seems to have an important role in genesis and maintenance of ASH, with current studies aimed     to understand this relationship.      Pathways used by SANS for immediate control of BP (wich are reticulate formation, bulb and     cortex) appear to be similar to pathways used for postural control reflex (reticulate     formation, bulb, cortex, among others), which are also used by Postural Reprogramming Insoles     (PRI) for posture adequacy. Due to this similarity in reflex activation areas, it is believed     that PRI may have some effect on BP regulation.      There are many ways to treat postural changes and one of them is posturology, which is based     on therapeutic use of postural reprogramming insoles (PRI). PRI activates tonic-postural     system, rebalancing muscles, joints and bony structures of body segments, and returning     individual to an appropriate posture.      The PRI is composed of a central artifact, situated in reflex zone full of somatosensory     stimuli captors, which generates a frequency of vibration that promotes postural adaptation.   "
67552|NCT02401503|"     The CLL2-BAG-trial is a prospective, open-label, multicenter phase-II trial to evaluate the     efficacy and safety of a sequential regimen of a debulking with Bendamustine followed by an     induction with GA101 (obinutuzumab) and ABT-199 (venetoclax, GDC-0199) followed by ABT-199     and GA101-maintenance in CLL patients   "
67553|NCT02401490|"     To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade     II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death     and/ or liver transplantation).   "
67554|NCT02401477|"     This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID     and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.   "
67555|NCT02401464|"     The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2     different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536     commercial tablet in healthy Japanese adult male participants.   "
67605|NCT02400814|"     This pilot phase I trial compares administration schedules of anti-programmed cell death-1     ligand 1 (PD-L1) monoclonal antibody MPDL3280A and stereotactic ablative radiotherapy in     treating patients with stage IV non-small cell lung cancer. Monoclonal antibodies, such as     anti-PD-L1 monoclonal antibody MPDL3280A, may block tumor growth in different ways by     targeting certain cells. Stereotactic ablative radiotherapy, also known as stereotactic body     radiation therapy, is a specialized radiation therapy that delivers a single, high dose of     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal     tissue. Giving anti-PD-L1 monoclonal antibody MPDL3280A with stereotactic ablative     radiotherapy may be a better treatment for non-small cell lung cancer. However, it is not yet     known what the best administration schedule is for these treatments.   "
67814|NCT02398097|"     Several studies have shown poor immune response to conventional influenza vaccines in     HIV-infected individuals. This study was conducted expecting the more potent immunogenicity     of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected     adults.   "
67556|NCT02401451|"     The 12-lead ECG is an essential tool in cardiovascular assessment. Novel technology has the     potential to improve the diagnostic yield of arrhythmias, whilst improving the patient     experience.      The RhythmPadGP is a novel device which acquires a 6-lead ECG without the need for the     patient to undress.      The aim of the study is to assess the ability of the device to diagnose cardiac rhythms.      Simultaneous recording of the RhythmPadGP 6-lead ECG will be undertaken at the same time as     the standard 12-lead ECG.      The 12-lead ECGs and 6-lead ECGs will be analysed by a Cardiologist, who will be blinded to     each set of ECGs and the automated diagnostic report produced by the RhythmPadGP device.      Such a novel diagnostic tool could replace the standard 12-lead ECG for rapid assessment and     diagnosis of arrhythmias. Additionally, as calls for a national screening programme to detect     atrial fibrillation (and prevent AF-related thromboembolism) currently intensify, the     RhythmPad has the potential to revolutionise how we screen our patients.   "
67557|NCT02401438|"     5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery     to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D     ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound     in predicting actual birth weight .   "
67558|NCT02401425|"     The purpose of this study is to compare the success rate of letrozole and misoprostol versus     misoprostol alone for medical termination of first trimester pregnancy.   "
67559|NCT02401412|"     Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin     barrier that is designed to maintain adhesive properties and good peristomal skin health     compared to other currently marketed barriers.   "
67560|NCT02401399|"     Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular     diet , preoperative balanced energy high protein formula and Immunonutrition     formula.Postoperative pain and acute phase reactants at 24hours after surgery are     investigated.   "
67561|NCT02401386|"     In this randomized, usual therapy-controlled study, 62 patients with FM were recruited with a     ratio of 1:1. Trained and guided by LEB certified physicians, participant practiced LEB one     hour, twice a week for 12 weeks. Evaluation will be based on standard scales of pain, FM     symptoms severity, degree of fatigue, depression, sleep quality and quality of life.   "
67562|NCT02401373|"     This is a single center, open, dose-escalation phase 1 clinical trial. This study will     determine the safety and side-effect profile, and immunogenicity of an investigational     Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.   "
67563|NCT02401360|"     This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed     toothpaste and manual toothbrush.   "
67564|NCT02401347|"     The aim of this single-arm phase II clinical trial is to evaluate the anti-cancer activity of     Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific     genetic or tumor genomic alterations. Patients with either triple-negative or HER2-negative     breast cancer are eligible.   "
67565|NCT02401334|"     This prospective clinical study will evaluate the safety and efficacy of the Cook®     Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue     during ventral or incisional hernia repair in clean-contaminated, contaminated, and     dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients     will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be     followed for 12 months.   "
67566|NCT02401321|"     This pilot clinical trial studies the Taking Care of Her program in patients with stage III     or IV ovarian cancer and spouse caregivers. This counseling program may equip the spouse     caregiver with skills to support and nurture the patient through initial diagnosis and     treatment. It may also help patients and spouse caregivers improve communication and coping     skills.   "
67567|NCT02401308|"     The purpose of the proposed study is to demonstrate that the functional outcomes of DBS     surgery utilizing the asleep technique are not inferior to those reported for traditional     awake DBS technique.   "
67568|NCT02401295|"     The purpose of this study is to evaluate the safety and tolerability associated with the     combination of ATRA/celecoxib/itraconazole as maintenance therapy given after an autologous     stem cell transplant in relapsed multiple myeloma patients.   "
67569|NCT02401282|"     This study examines the way attention may be linked to temperamental risk for anxiety, social     behavior and brain processes. The study aims to see if temperamentally at risk youth display     an attention bias towards threat, and if anxiety symptoms can be reduced through attentional     bias modification training.   "
67570|NCT02401269|"     CVD accounts for 15% of all deaths in Malawi. Both HIV and ART are risk factors for CVD     through direct toxic and inflammatory cardiovascular effects. (44,45). At the moment, one out     of every 10 Malawian is HIV positive and roughly 8 out of 10 of those infected are now on ART     (2). Therefore, HIV and ART may be contributing to the burden of CVD in Malawi. Currently,     there are only a few studies assessing CVD risk in the HIV patient population on ART. In     Malawi, no such studies exist. Therefore, the investigators propose a novel study assessing     baseline cardiovascular disease risk using two novel ultrasound technologies in HIV patients     on ART. Cardiovascular disease risk will be assessed using surrogate cardiovascular markers     of disease. These surrogates include markers of endothelial function and cardiovascular     modulating inflammatory biomarkers. The inflammatory biomarkers measured will be TNF-alpha,     IL-6, and CRP. Aspirin, by way of its antiplatelet and anti-inflammatory effect has been     demonstrated to inhibit atherosclerosis by way of decreasing TNF-alpha, IL-6, CRP and     improving endothelial function. Therefore a second aim of the study will be to demonstrate     that aspirin improves surrogate markers of atherosclerosis.   "
67606|NCT02400801|"     Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in     postoperative endometriosis patients? (A single centre randomised controlled trial)   "
67607|NCT02400788|"     The purpose of this study is to assess efficacy and safety in combination of resminostat and     sorafenib in Asian patients with advanced HCC previously untreated with systemic     chemotherapy.   "
67608|NCT02400775|"     The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32     weeks on coronary artery plaque in essential hypertensive patients with stable angina and     dyslipidemia.   "
67571|NCT02401256|"     The CYP2B6 enzyme metabolizes a growing number of clinically important drugs such as the     anti-HIV drug efavirenz, but its activity in the liver is highly variable, which may lead to     failure of therapy or toxicity and unpredictable drug interactions. Genetic and several     nongenetic factors affect the activity of CYP2B6. The goal of this study is to determine the     impact of simultaneous autoinhibition/autoinduction and CYP2B6 genetics on CYP2B6 activity,     efavirenz exposure and efavirenz-mediated drug interactions. The pharmacokinetics and drug     interactions will be determined on three occasions in a total of 60 healthy volunteers. The     whole study will have 4 phases. A) Phase 1 (baseline control): using selective probe     substrates, the baseline activities of CYP2B6 (bupropion), CYP2C8 (montelukast) and OATP1B1     (rosuvastatin) are determined. B) Phase 2 (inhibition): the metabolism and pharmacokinetics     of a single 600 mg oral dose of efavirenz) and the activities of CYP2B6, CYP2C8 and OATP1B1     (inhibition) are determined. C) Phase 3 (treatment phase): After completing phase 2, subjects     take 600 mg/day efavirenz at home for 17 days. C) Phase 4 (induction and inhibition): At the     end of phase 3, steady state metabolism and pharmacokinetics of efavirenz and the activities     of CYP2B6, CYP2C8 and OATP1B1 will be determined. Efavirenz serves as a model substrate,     inhibitor and inducer of CYP2B6 (and other drug disposition proteins). Bupropion     4-hydroxylation is an alternative in vivo probe of CYP2B6 activity and will be studied here     in addition to the metabolism and pharmacokinetics of efavirenz.   "
67572|NCT02401243|"     Primary Objective:      The primary objective of this study is to obtain efficacy and safety descriptive data on 2     different titration algorithms: the INSIGHT titration algorithm (self-titration of 1     unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as     basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with     or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.      Secondary Objective:      The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin     [A1C], fasting plasma glucose [FPG], 7-point self-measure plasma glucose [SMPG], insulin dose     and weight) and determine patient related outcome and health care professional satisfaction     as it pertains to each titration regimen.   "
67573|NCT02401230|"     The purpose of this study is to determine whether the use of rectal lubricants can affect how     well the medication, Truvada, will work to prevent infection with HIV when someone is exposed     to HIV in the rectum.   "
67574|NCT02401217|"     The primary objective of this study is to assess the comparative gastrointestinal tolerance     of normal term infants to two experimental milk-based powdered formulas compared with a     standard milk-based powdered formula.   "
67575|NCT02401204|"     Infections with multiply antibiotic-resistant bacteria represent a major cause of preventable     morbidity and mortality amongst hospitalized neonates worldwide. In Southeast Asia, where     antibiotic-resistance is a major problem, Gram-negative bacteria account for the majority of     such infections. The most common pathogens are Acinetobacter spp., Pseudomonas aeruginosa,     Enterobacter spp., Escherichia coli and Klebsiella pneumonia. The great majority of     infections with these pathogens represent asymptomatic carriage, though in the absence of     routine screening for asymptomatic carriage reliable estimates of the prevalence, rates of     transmission between patients, and rates of importation from the community are lacking.     Moreover, current understanding of the degree and manner in which different antibiotics act     to select for such resistant organisms is rudimentary.   "
67576|NCT02401191|"     Primary Objective:      To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10)     combination tablet in patients with allergic rhinitis.      Secondary Objective:      To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal     symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.   "
67577|NCT02401178|"     The incidence of atopic dermatitis has increased dramatically in this years. Atopic     dermatitis occurs due to complex interactions between genetic and environmental factors. One     of the genes that consistenly linked with AD occurences is filaggrin gene (FLG gene).     Mutation on the gene can induce disruption in epidermal cytoskeleton aggregation which serves     to form protein-lipid, thereby disrupting the skin permeability to water and outside     particles such as allergens.8-14 Several attempts have been made to prevent the occurences     and progressivity of AD, one of them is LCPUFA supplementation. Until now, the clinical and     meta-analysis studies have shown inconsistent results, but LCPUFA intervention in early life     gives more consistent and protective results. In this study investigators would like to know     about the influence of FLG gene mutation to the occurrence of atopic dermatitis, to know the     composition of LCPUFA in early life in order to see protective effects of several LCPUFA, to     see the influences of FADS1 and FADS2 gene polymorphism towards LCPUFA concentration from     buccal swab in early life and at the time AD occurs, to know about the diet at the time of AD     occurrence, and to know the role of the ratio of DHA towards AA level in the development of     AD due to their antagonistic effects, and to see the interactions between FLG gene, FADS gene     and LCPUFA level in the development of AD.   "
67578|NCT02401165|"     GADD34 is an inducible cofactor of protein phosphatase 1, which has an important role in the     Unfolded Protein Response (UPR). UPR is a cellular response to ER stress which is implicated     in several autoimmune diseases. GADD34 has been shown to be necessary for proinflammatory     cytokine production in response to viral infection in murine models. Nevertheless, the role     of GADD34 in cytokine production in humans remains to be elucidated. Here, we investigate the     interest of GADD34 in rheumatoid arthritis (RA), in which proinflammatory cytokines have an     important pathogenic role.      A case-control study on GADD34 gene expression in PBMC of patients (n=75) with RA and age-     and sex-matched healthy controls (n=25). GADD34 gene expression levels in PBMC were measured     by quantitative PCR.   "
67755|NCT02398864|"     To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and     safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy   "
67636|NCT02400411|"     This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses     elicited by meals containing either whole grain rye bread or white wheat bread as such or     combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations     are monitored from finger prick blood samples collected before the meal and at 15, 30, 45,     60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30     and 60 min.   "
67583|NCT02401100|"     The purpose of this study is to determine whether reduced rectal blood flow is associated     with the extent of surgery when performing an operation to remove rectal cancer. The     investigators also aim to describe any relation of reduced rectal blood flow, as well as     raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage.     The patients will be recruited at Umeå University Hospital and all patients who are planned     to undergo anterior resection for rectal cancer and able to consent are eligible for this     study. Rectal blood flow measurements will be conducted with Laser-Doppler technology using     noninvasive measuring probes. Preoperative and postoperative blood sampling as well as     postoperative drain fluid collection will take place. Perianastomotic tissue will also be     collected. In the postoperative period, any occurrence of surgical complications especially     anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation to     type of mesorectal excision (total or partial) and correlated to anastomotic leakage.     Standard statistical tools will be utilized, such as parametric, non-parametric tests and     logistic regression, as appropriate. The study will recruit approximately 90 patients during     three consecutive years.   "
67584|NCT02401087|"     The aim of this observational study was to evaluate, based on the intraoperative anesthetic     that is routinely carried out at the Department of Day Surgery, the difference in timing of     the patient's discharge from the hospital (ie when the patient has autonomous demabulation     and urination spontaneous) in patients undergoing correction of varicocele according Marmar.   "
67585|NCT02401074|"     Airway irritation, cough and bronchial spasm are common symptoms in patients with airway     inflammatory diseases such as asthma. The primary focus of this exploratory study is to     determine if there is an increase in tissue temperature in airway mucosa during asthma     exacerbation. The results of this study will bring a better understanding of the potential     involvement of an increase in airway mucosa temperature in the pathogenesis of various     symptoms in these patients. The finding should help to advance the development of new     therapeutic strategies for these debilitating diseases.   "
67586|NCT02401061|"     Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may     lead to improved platelet levels where these are decreased due to immunological pathologies     and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been     shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The primary     objective of the study is to assess the efficacy of PRTX-100 in terms of platelet response in     patients with chronic/persistent ITP.   "
67587|NCT02401048|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of the     combination treatment of ibrutinib and MEDI4736 in patients with relapsed or refractory     lymphomas.   "
67588|NCT02401035|"     The purpose of this study is to characterize the pharmacokinetics (PK) and safety of     intravenous (iv) pantoprazole in patients 1 to 16 years old who are candidates for acid     suppression therapy.   "
67589|NCT02401022|"     To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.   "
67590|NCT02401009|"     The primary goal of the CIBMTR Research Program is to improve the safety and effectiveness of     hematopoietic cell (HC) transplantation for both donors and recipients.   "
67591|NCT02400996|"     A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.   "
67592|NCT02400983|"     The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm     algorithm in the automatic management of atrial capture.   "
67593|NCT02400970|"     For prepubertal patients, cryopreservation of testicular tissue is the only option available     to preserve their fertility before cancer treatment. But testicular autograft raises the     issue of the risk of reintroduction of potentially malignant cells. The aim of our study is     to develop a specific and sensitive method for residual disease detection in the testicular     tissue from patients treated for a solid tumor during infancy, whose fertility may have been     compromised by treatments and who benefited of testicular tissue cryopreservation.   "
67594|NCT02400957|"     Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic     Transbond XT in preventing enamel demineralization adjacent to brackets.   "
67595|NCT02400944|"     The purpose of this study is to learn how different lifestyle factors, such as cigarette     smoking and body weight, change after a diagnosis of bladder cancer, and how they influence     who gets a bladder cancer recurrence and who does not.   "
67596|NCT02400931|"     The mask ventilation is a necessary procedure to provide oxygenation before the tracheal     intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex,     which is recently introduced, enables the use of high-dose muscle relaxant without concerning     the delayed recovery of neuromuscular blockade. It seems that there is no need to perform the     mask ventilation in adults with normal airway if the investigators use high-dose muscle     relaxant for the anesthetic induction because adequate muscle relaxation can be achieved     within 1-2 minutes. Therefore, the investigators hypothesized that routine mask ventilation     is not needed in adult patients with normal airway. The investigators will compare the     incidence of desaturation and gastric insufflation between the patients with mask ventilation     and the patients without mask ventilation.   "
67610|NCT02400749|"     This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects     with moderate to severe plaque psoriasis involving palms and/or soles.      Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared     against placebo (dummy drug with no active ingredient).      This study will enroll approximately 100 adult subjects with moderate to severe plaque     psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be     eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles,     with lesions covering at least 10% of the surface of palms and soles at the baseline visit.     Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning     that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the first     16 weeks. Subjects will not know which of the two treatments they receive. The study doctor,     the study staff will not know which treatment they receive either. All subjects will receive     Apremilast from Week 16 to Week 32.      Subjects will be asked to complete questionnaires about their hand and feet pain, their     quality of life, their general health and the impact of psoriasis on their work.      Medical photographs of palms and soles will be taken for subjects at selected study sites     only.      At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies     can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or     certain cellular messengers that can be quantified. It is also possible to study the skin     cellular structure and organization.      A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms or     soles and one biopsy from normal skin of palms or soles will be collected. At Week 16 visit,     only one biopsy from psoriasis on palms or soles will be collected.   "
67756|NCT02398851|"     The overall aim of this study is to create a trans-disciplinary chronic disease continuity of     care model with health information technology, utilizing mobile devices such as tablets,     iPads and smartphones.   "
67597|NCT02400918|"     Social anxiety disorder (SAD) is the most common anxiety disorder, affecting up to 10% of the     population and causing significant distress. Fortunately, there are effective interventions     including cognitive behavior therapy (CBT) and acceptance and commitment therapy (ACT).     However, only about a third of people with SAD seek treatment. There are a number of barriers     to seeking treatment, including cost, availability, and stigma. Self-help may be one way to     reach people who may not otherwise present for treatment. Research on self-help books for SAD     based on CBT has yielded promising results. However, no research to date has examined the     efficacy of ACT-based self-help for SAD. The primary purpose of the present study is to     evaluate The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness     (Fleming & Kocovski, 2013), an ACT-based self-help book. Socially anxious participants will     be randomly assigned to receive the workbook or be placed on a waitlist. It is hypothesized     that workbook participants will report significantly reduced social anxiety at the end of     eight weeks compared to waitlist participants. The secondary purpose is to evaluate how the     treatment works. Increases in mindfulness and acceptance have been shown to lead to reduced     social anxiety. These same variables will be examined in the present study. Finally, this     research aims to examine variables that can predict who may do well in treatment. Given that     two-thirds of people who meet criteria for this disorder will not seek traditional     treatments, it is important to develop and evaluate alternative treatments, including those     based on self-help.   "
67598|NCT02400905|"     To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA     Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of     symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm,     multicenter clinical trial.   "
67599|NCT02400892|"     This study will involve patients who are planned to have hip or knee replacement surgeries.     They will undergo a Transthoracic Echocardiogram study (an ultrasound of the heart) to look     for a Patent Foramen Ovale (PFO). A PFO is a hole in the heart that everyone is born with and     in most cases eventually closes by adulthood. However, it does not always close in all     people. The investigators will compare the participants as two groups - those with a PFO, and     those without, and look for differences in delirium in their postoperative stay. This will     help us look for an association between postoperative delirium and the presence of a PFO.   "
67600|NCT02400879|"     Background: Although remifentanil based anesthesia has been preferred for fast-track cardiac     anesthesia, its recovery profile in cognitive function has not been investigated. Authors     determined postoperative Bispectral index (BIS) score as well as extubation time after     remifentanil-based propofol-supplemented anesthesia and compared them with those after     conventional balanced sevoflurane-sufentanil anesthesia.      Methods: Patients undergoing cardiac surgery using moderate hypothermic cardiopulmonary     bypass (CPB) will be randomly allocated to get remifentanil-based propofol-supplemented     (Group R) or conventional sevoflurane-sufentanil regimen (Group C) in the study period. For     anesthetic induction and maintenance, fixed target controlled infusion (TCI) of remifentanil     (plasma concentration 20 ng/ml) and TCI-propofol for maintaining BIS score 40-60 (effect     concentration 0.8-1.5 μg/ml) in Group R, and TCI-sufentanil (Cp 0.4- 0.8 ng/ml) and     sevoflurane inhalation for maintaining 80-120 % of baseline BP and BIS < 60 (< 1.5 MAC) in     Group C, respectively.      Authors will analyze postoperative recovery of cognitive function by using BIS after the use     of remifentanil-based propofol-supplemented anesthesia for cardiac surgery and to compare     them to those after the use of conventional balanced sevoflurane-sufentanil anesthesia.   "
67601|NCT02400866|"     This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of     chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic     chemotherapy by a randomized, double-blind, placebo-controlled trial.   "
67602|NCT02400853|"     The most frequent complications in premature infants are neurological complications:     intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of severe     intraventricular hemorrhages remains stable. Severe hemorrhages are associated with     neurological sequelae.      A recent study in humans and in animals shows the role of the complex formed by plasminogen     activator (t-PA) and its inhibitor (PAI-1) in the induction of vascular fragility via     stromelysin (MMP-3). FIBRINAT study in Rouen University Hospital showed a rate of complex     t-PA-PAI1 probably very high in preterm infants. An other factor maturation PDGF-C induced by     t-PA is associated with the vascular embrittlement. Among the few genetic factors associated     with cerebral palsy include 2 SNP of PAI-1 gene and one SNP in the gene of endothelial NO     synthase.      The hypothesis is that a high rate of the complex t-PA-PAI-1 in cord blood could be a high     risk of intracranial hemorrhage in preterm infants and provide predictive of their     occurrence. The rates of MMP-3, PDGF-C and PAI-1 free in cord blood, and the polymorphism of     PAI-1 gene and eNOS could separately or associated with the main criterion to identify     predictive of hemorrhages.      The main objective is to search a rate difference of the complex t-PA-PAI-1 in cord blood of     preterm infants (before 30 weeks of gestation) that would predict intracranial hemorrhage     coming in the first days of life.      The secondary objectives are        -  Evaluate potential marker risk of high levels of MMP-3, PAI-1 free, and PDGF-CC        -  Search in both groups the presence of alleles -675G4 / G5 and 11053 (G / T) of the PAI-1          gene and -922 (A / G) of the eNOS gene.           120 preterm infants will be included before 30 weeks of gestation with precise inclusion          and exclusion criteria during a period of 3 years.      Patients will be divided into two groups according to whether they will or not showed     intracranial hemorrhage (detected by ultrasound J5-J7).      The complex rate tPA-PAI-1, PAI-1 free, MMP-3 and PDGF-C will be measured. The comparison     between the two groups will be carried out using statistical tests. Comparison of the     presence of the alleles -675 4G and 11053T the PAI-1 gene or -922G eNOS gene between the two     groups will be performed.      The demonstration of this hypothesis would permit to identify children from birth in whom the     immediate implementation of preventive treatment of bleeding is desirable.   "
67603|NCT02400840|"     Acute heart allograft rejection is a common complication after orthotopic heart     transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute     heart graft rejection screening, by detecting changes in myocardium structure especially     extracellular volume.   "
67604|NCT02400827|"     For prepubertal patients, cryopreservation of ovarian tissue is the only option available to     preserve their fertility before cancer treatment. But ovarian autograft raises the issue of     the risk of reintroduction of potentially malignant cells. The aim of our study is to develop     a specific and sensitive method for residual disease detection in the ovarian tissue from     patients treated for a solid tumor during infancy, whose fertility may have been compromised     by treatments and who benefited of ovarian tissue cryopreservation.   "
67620|NCT02400619|"     Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with     cerebral palsy, having a significantly effect on their mobility and quality of life. There is     much controversy about what is the most appropriate treatment of spasticity The objective of     the present study is to evaluate the effects of radial extracorporeal shock wave therapy     (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with     cerebral palsy      The number needed of patients is 70 (35 per group). Leaving a period of washout between one     therapy and the other   "
67611|NCT02400736|"     In response to the Rehabilitation Research and Development (RR&D) Deployment Health Research,     this study addresses the delivery of an evidenced-based vocational rehabilitation,     specifically Individual Placement and Support (IPS), for Veterans who often face unemployment     and mental illness as they try to recovery from illness and re-establish civilian life. This     study provides the requisite evidence needed to guide VHA as to whether to expand the target     population for IPS to all Veterans with a mental disorder, delivered directly within the     primary care setting (i.e. Patient Aligned Care Team; PACT). Such modifications in VHA     practice could substantially improve Veteran vocational rehabilitation access and outcomes,     moving a significantly greater number of disabled Veterans back to full and productive lives     in the community.   "
67612|NCT02400723|"     Anxiety leads to poor quality of life, avoidance of activities, decreased social engagement,     functional decline, and disability in older patients. This study will compare two     self-directed treatments delivered via DVD videos that can be viewed in one's own home. The     two treatments being compared are: psychoeducation, which refers to information and education     about anxiety, and a behavioral treatment program, called BREATHE (Breathing, Relaxation and     Education for Anxiety Treatment in the Home Environment). BREATHE teaches diaphragmatic     breathing and progressive muscle relaxation. Participants will be randomly assigned to either     treatment. The study is 12 weeks long. There are 4 weeks of treatment via DVD and 8 weeks of     follow-up. Participants will be asked questions about anxiety symptoms, mood, health and     functioning.   "
67613|NCT02400710|"     PTSD Coach is a mobile application (app) that aims to teach individuals self-management     strategies for symptoms of Post-traumatic Stress Disorder (PTSD). Despite PTSD Coach's use of     evidence-based cognitive behavioral strategies there is still a need to test the     effectiveness of the app in managing PTSD symptoms. There is research evidence that     self-management programs are often underutilized, but that clinician contact can increase     patient involvement. The addition of clinician support may enhance the utilization and     effectiveness of the PTSD Coach. In Phase 1 the investigators propose to conduct stakeholder     interviews with primary care (PC) and mental health (MH) leadership staff to investigate     barriers and facilitators to implementing Clinician-Supported (CS-PTSD Coach) to increase the     uptake, use, and impact of PTSD Coach by PC patients. The interviews will inform the     development of a CS-PTSD Coach protocol and manual that will be used in phase 2. In phase 2     the investigators propose to conduct a feasibility study where 30 (20 eligible) PC Veterans     with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive     Self-Managed (SM) PTSD Coach or CS-PTSD Coach. The investigators' specific aims are to 1)     investigate the feasibility of recruiting and retaining participants and delivering the SM     and CS conditions and 2) conduct a preliminary investigation of the efficacy of SM vs. CS.     The investigators predict that CS will lead to greater treatment gains than SM. Effect sizes     will be generated for the following outcomes: a) reductions in PTSD, depression, and general     distress, and increases in health-related functioning, b) increases in knowledge about PTSD     symptoms, PTSD management strategies, and patient coping self-efficacy, c) increases in     initiation of tradition PTSD treatments.   "
67614|NCT02400697|"     The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the     World Health Organization have recently published recommendations related to placental     transfusions in preterm infants. This project will review outcomes of preterm infants     following a quality improvement implementation process in several delivery centers in     Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford Network     (IRB#1003-84). Data is recorded for that network and the investigators site will be reviewing     that data every 3 months from infants who have completed the Vermont Oxford Network     collection. This project will specifically look at the incidence of intraventricular     hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death     following the implementation of the ACOG recommendations.   "
67615|NCT02400684|"     Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be     ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according     to severity, and the stage is established on the basis of intra-operative observations. The     AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most     associated with endometriosis are subfertility and pelvic pain.      In the surgical management of deep endometriosis, the issue of fertility is pivotal. There is     a higher rate of infertility in a population of women with endometriosis as compared to the     general population, even though the mechanisms are not yet elucidated. Patients with deep     endometriosis can be referred to the surgeon for subfertility, but even when they are     referred for chronic pain, future fertility considerations are taken into account in the     planning of the surgery, as the patients are often young.      It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian     reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian     reserve is the functional potential of the ovaries, reflecting the quantity and quality of     remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian     hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently     the most reliable marker to assess ovarian reserve. A significant difference was found     between AMH before and following cystectomy in several studies. The deleterious effect of     deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis     in many cases, even when no cystectomy has been performed, is therefore not entirely ruled     out. To the best of our knowledge, there are no studies on the effect of deep endometriosis     surgery, apart from ovarian surgery, on ovarian reserve.      Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with     more than 200 cases every year. The objective of this trial is to assess the effect of deep     endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by     measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.   "
67616|NCT02400671|"     The investigators are conducting a 3-arm randomized trial comparing the effects of     unidirectional SMS (ie: push messaging to participant) vs. bidirectional SMS dialogue     between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in     Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.   "
67617|NCT02400658|"     The purpose of this study is to evaluate an investigational way to provide radiation therapy     to treat early-stage breast cancer at the time of surgery.   "
67618|NCT02400645|"     In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain     relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal     bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in     patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.   "
67619|NCT02400632|"     The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late     lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary     Angiography / Intravascular Ultrasound examination for the treatment of coronary artery     lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.   "
67622|NCT02400593|"     Growing up in a low-income household has been shown to increase risk for, and susceptibility     to many illnesses.The purpose of the study is to test an affective intervention for reversing     biological risk factors, as related to childhood adversity, in midlife.      Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation     classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys,     and two 30-minute surveys prior to each lab visit. During the lab visits, participants will     have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse.     Participants will also have their blood drawn.      All surveys and questionnaires inquire about participants' current demographics, family     history, perceptions about life and well-being, physical health, and monetary choices.   "
67623|NCT02400580|"     The objective of this study is to quantify the change in post-operative pain scores and     narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to     placebo in women undergoing laparoscopic hysterectomy.   "
67624|NCT02400567|"     The investigators propose in the present study an innovative approach, combining the most     recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and     innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response     evaluation method. In line with the most recent recommendations on targeted anticancer     therapies, the investigators have designed a parallel phase II randomized trial with early     stopping rules 26, which will able in the meantime to build a unique prospective collection     of tumor tissue, pre- and post-treatment.   "
67625|NCT02400554|"     This is an obesity and alcohol, tobacco, and other drug (ATOD) use risk prevention and health     leadership program. This project will include 150 at-risk adult Native women across 5     communities (30 women from each community) in the Choctaw Nation of Oklahoma. The     intervention targets individual behavioral change relative to ATOD and obesity prevention and     simultaneously provides behavioral skills for health promotion leadership.      Investigators will conduct a longitudinal study using a cluster randomized stepped-wedge     design to evaluate the intervention impact on ATOD and obesity prevention primary aims of:     (1) substance use harm reduction and ATOD use and intentions to use; and (2) reduction in     weight/body mass index (BMI) and increase in leisure-time physical activity/physical activity     (LTPA/PA) and healthful food habits. Specifically, investigators will ask participants to     participate in up to eight group sessions (based on a curriculum drawing on cultural     teachings around health and behavioral change); attend up to three Motivational Interviewing     individual sessions (to identify individual behavioral change goals); attend a two-day     overnight culture and Trail prep camp; participate in camping and walking for up to 10 days     on the Trail; and attend up to six post-walk meetings (to develop community health events).     All five communities will also be asked to complete a baseline health assessment as well as     three follow up assessments over the course of the year. Additionally, communities 2-5 will     participate in three pre-intervention health assessments. This intervention integrates     components of motivational interviewing, information-motivation-behavior, and a leadership     development framework for adults. It targets individual behavioral change relative to ATOD     and obesity prevention and simultaneously provides behavioral skills for health promotion     leadership within their respective communities.The project addresses a critical public health     issue among a group experiencing considerable health disparities and strengthens the research     infrastructure in partnership with the Tribe. If efficacious, it has the potential for     widespread dissemination and could be generalizable to other chronic co-occurring mental     health and physical health conditions.   "
67626|NCT02400541|"     The aim of research is to test in a randomized clinical trial with active sessions, the     efficacy of cognitive remediation therapy in children anorexia nervosa compared to a     controlled group. The investigators want to confirm the efficacy of cognitive remediation     treatment in children's flexibility problems.   "
67627|NCT02400528|"     The studies conducted so far concerning the medical and paramedical cares provided to     patients with profound and multiple disabilities (PMD) often show important limitations:     samples are too small or very heterogeneous, generally constituted of children only; studies     are mainly cross-sectional and retrospective, focusing on very specific issues instead of     assessing health and quality of life from a more global perspective… So far, the     investigators found no published data from a prospective cohort study involving a     representative sample of patients with PMD. The present project aims to set up such a cohort     so as to describe for the first time the natural history of French patients with PMD as well     as the cares they receive at home or within the different dedicated structures in France.     This cohort will also make it possible to identify the factors responsible for differences in     the cares patients are provided, the consequences of these differences on their health and     their quality of life (and those of their relatives) as well as the evolutions of these data     over time. It will then allow for assessing the effectiveness of the French healthcare system     to care for patients with PMD as well as building a frame of reference regarding the best     cares to provide to these patients.      The primary goal of this study is to identify the determinants of health among patients with     PMD.   "
67628|NCT02400515|"     This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on     glucose and lipid metabolism as well as the scales of anxiety and depression and levels of     salivary cortisol in women with type 2 diabetes.   "
67629|NCT02400502|"     Integrated Coping and Awareness Therapy is a novel therapeutic intervention combining     strategies to improve stress reactivity and increase meaningful coping, as well as a range of     possible proximal (e.g. immune indices of stress reactivity, symptom severity) and distal     measures (e.g. relapse, quality of life).   "
67630|NCT02400489|"     To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or     2800TFX) from three hospitals in China.      To track the patients'situations during one year after surgery and to collect the relevant     clinical data.   "
67631|NCT02400476|"     An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with     Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis   "
67632|NCT02400463|"     This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic     syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily     in patients with HPS. The primary endpoint is overall survival at two months.   "
67633|NCT02400450|"     This is a multi-site, double-blind, randomized, controlled food intervention study being     conducted at the Canadian Centre for Agri-Food Research in Health and Medicine (CCARM) in     Winnipeg and the Mayo Clinic, Rochester, MN, to examine the effects of a portfolio of     functional foods on blood glucose and lipids, and blood vessel function in individuals with     prediabetes.      A total of 116 participants (n=58/site) with prediabetes (hemoglobin A1c ≥6.0 & <7.0 and no     glucose-lowering medications) and body-mass index (BMI) 18-40 will be recruited for a 12-week     clinical trial to determine the effect of eating 2 items containing functional ingredients     daily compared to 2 similar items lacking the functional ingredients. Study foods provided     are to be incorporated into participant's usual diet.   "
67637|NCT02400398|"     Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia     defined as greater than 5% unintentional weight loss within 6 months prior to screening     visit. Patients must be greater than 18 years of age; and have greater than 3 months life     expectancy.      This study will observe a standard of care intervention (tube feeding) for potential benefit.     Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing     will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the     duration of the protocol.   "
67638|NCT02400385|"     This will be a phase II trial of the combination of sunitinib and nivolumab in patients with     advanced, measurable, metastatic melanoma who harbor mutations in the KIT gene in their     tumors. It is a multi-center trial using the FDA-approved doses of both sunitinib and     nivolumab. Sunitinib will be provided by Pfizer. Endpoint is RECIST response rate and PFS.   "
67639|NCT02400372|"     The study, Evaluation of the effect of antibacterial medical honey dressing for healing of     implants donor area, is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment     groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of     antibacterial medical honey dressing in the therapy of donor area of implants. In our     Research Will participate in 135 new patients over the age of 18, with a wound in the donor     area of hip implants, Hospitalized in the Plastic Surgery Unit of the Haemek Medical     Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned     randomly to one of three treatment groups:        1. The research group: Medihoney antibacterial wound dressing.        2. The control group: Paraffin gauze with saline- The basic treatment in the donor site,          accepted the literature.        3. Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic          Surgery Unit of the Haemek Medical Center.      Participants in the three study groups will be performed, each visit, Medical monitoring and     examination by a team of medical indices of Plastic Surgery Unit, as is customary. The     treatment will be performed, twice a week until recovery and the complete closure of the     wound.   "
67640|NCT02400359|"     The purpose of this protocol is to investigate, using functional magnetic resonance imaging     (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite     and food intake, as well as lorcaserin's downstream metabolic effects.   "
67641|NCT02400346|"     The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as     adjunctive treatment in an elderly population with major depressive disorder and an     inadequate response to antidepressant treatment   "
67642|NCT02400333|"     This study will be an open-label, randomised, four-period, four-treatment, crossover study in     healthy male and female of non-childbearing potential subjects, performed at a single study     centre.      The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD)     tablets when administered with water, without water and suspended in water to be administered     through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets   "
67643|NCT02400320|"     The purpose of this study is to determine local skin safety of a topical analgesic spray     containing a combination of diclofenac, methyl salicylate, menthol and compare it with a     topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol.   "
67644|NCT02400307|"     This study will evaluate the pharmacokinetic (PK) profile, safety, and tolerability of oral     GS-9883 in adults with impaired renal function relative to matched, healthy controls with     normal renal function. Each participant in the renal impairment groups will be matched for     age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2)] with a     participant in the control group.   "
67645|NCT02400294|"     Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on     prevention of ventilator associated pneumonia   "
67646|NCT02400281|"     This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with     standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine,     FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine   "
67647|NCT02400268|"     The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria     are becoming more and more frequent, and available antimicrobial agents are usually scarce.     Reducing the duration of antimicrobial treatments is one of the most efficient measures to     control the antibiotic pressure and to optimise the use of these agents.      Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal     duration of antibiotics to treat them is unknown, as long as no clinical trials have been     specifically developed to answer this question.      Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the     bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days.     This represents a variability of up to 100%. No recommendations have been published regarding     the duration of treatment of bacteremia from other sources.      The objective of this project is to prove that the 7-day course of treatment for EB     bacteremia is more efficient and equally safe than the 14-day scheme.   "
67648|NCT02400255|"     This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3     mutations who have achieved complete remission (CR) after allogeneic stem cell     transplantation. Oral crenolanib will be administered daily post-transplant for up to two     years.   "
67650|NCT02400229|"     The primary hypothesis is that computertomography (CT) is superior to invasive coronary     angiography (ICA) concerning the primary endpoint MACE (MACE = major adverse cardiovascular     event; defined as at least one of the following: cardiovascular death, nonfatal myocardial     infarction, and nonfatal stroke) after a maximum follow-up of 4 years, in other words, that     CT will result in a significantly lower rate of MACE. Secondary outcomes include MICE (MICE =     minor cardiovascular events), procedural complications, cost-effectiveness, radiation     exposure, cross-over to CT or ICA, gender differences, and health-related quality of life.   "
67762|NCT02398773|"     This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography     (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with     newly diagnosed breast cancer that has spread to other parts of the body. FES is a     radioactive form of the hormone estrogen and may light up where cancer is in the body.     Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help     doctors predict how well the cancer will respond to treatment.   "
67651|NCT02400216|"     Background:      - Hepatitis C infection (HCV) is a leading cause of liver disease. Normal bacteria from the     intestines may spread to the liver and blood during liver disease. This is called bacterial     translocation (BT). Researchers think BT may cause liver disease to worsen.      Objectives:      - To study the mechanisms involved in BT in early and advanced liver disease. To find out     whether BT causes liver disease to worsen.      Eligibility:      - People over age 18 with HCV and clinically stable liver disease.      Design:        -  Participants will be screened with medical history and physical exam. They will have          blood tests and imaging studies.        -  Participants will have 2 outpatient visits and a 3-day stay at the clinic.        -  At visit 1, participants will have urine and blood tests. They will have a magnetic          resonance imaging (MRI) scan. A solution will be injected into a vein. The MRI scanner          is a metal cylinder surrounded by a magnetic field. The participant will lie on a table          that slides in and out of the cylinder.        -  At visit 2, a substance will be injected into a vein and swallowed. Participants will          then have blood drawn 5 times over 90 minutes.        -  During the inpatient stay, serial blood tests will be drawn.        -  Participants will give 2 stool samples and have another MRI.        -  A needle will be inserted through the chest wall into a vein inside the liver, guided by          ultrasound. The blood pressure inside this vein will be measured and blood will be drawn          from it. About 1 inch of liver tissue will be removed.        -  A study investigator will call participants to discuss all test results.   "
67652|NCT02400203|"     The objectives of this trial are to assess the effects of hemp product consumption,     specifically hulled hemp seeds and hemp oil on blood fatty acid profiles and cardiovascular     disease risk factors, in healthy overweight volunteers after 4 weeks of consumption.   "
67653|NCT02400190|"     This study will collect rates of local/regional recurrence in select patients who do not     receive radiation treatment after lumpectomy surgery. These women must be postmenopausal;     have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal     to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect     prospective data supporting the idea that this is a population at sufficiently low risk of     local/regional recurrence that omission of adjuvant radiation might be a reasonable option.   "
67654|NCT02400177|"     The purpose of this study is examine emotional regulation and reflective functioning in     parents of children with Autism Spectrum Disorders (ASD) before and after an educational     training (four sessions workshop). Our experimental aims are the following: 1) examine     parental emotion regulation and reflective functioning in daily life, 2) examine children     emotion regulation in their daily life 3)Learn about the training efficacy for ASD parents.     This research study will help to formulate innovative treatment methods to reinforce positive     emotion regulation of both ASD children and their parents.   "
67655|NCT02400164|"     The study is a multi-center, prospective, open label, uncontrolled feasibility study     enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites.     Patients will be enrolled during a 6 month enrollment phase after which data will be     collected for 12months with an initial analysis after 3 months. Extended follow-up for safety     monitoring purposes will continue for the lifetime of the patient or until the device is     explanted.   "
67656|NCT02400151|"     The main objective of this study is to analyze in a population of obese adolescents, the     effect of vitamin D3 supplementation in addition to lifestyle and dietary management on     vascular function assessed by the change between M0 and M3 of endothelium-dependent     vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).   "
67657|NCT02400138|"     Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate     important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory     and expiratory muscles is required, mainly when performing physical activities,     rehabilitation interventions for stroke subjects should include respiratory training. This     study will test the hypothesis that home-based combined training of the inspiratory and     expiratory muscles is effective in improving strength and endurance of the inspiratory and     expiratory muscles, fatigue, exercise capacity, and quality of life with stroke subjects. For     this clinical trial, people after stroke will be randomly allocated into either experimental     or control/sham groups. The experimental group will undertake training of the inspiratory     plus expiratory muscles with the Threshold device regulated at 40% of the subjects' maximal     inspiratory and expíratory pressure values, five times/week over eight weeks during 30     minutes/day. The control group will undertake the same protocol, but the participants will     receive the threshold devices without the resistance valves. At baseline, post intervention,     and four and 12 weeks after the cessation of the interventions, researchers blinded to group     allocations will collect the following outcome measures: maximal inspiratory and expiratory     pressures, endurance, fatigue, dyspnea sensation, exercise capacity, and quality of life.   "
67658|NCT02400125|"     China Cardiovascular Surgery Registry (CCSR) Study is a national database for coronary artery     bypass grafting (CABG) and valve surgery performed in 87 hospitals with cardiovascular     surgery volume > 100 per year. The aims of CCSR Study are: (i) report the characteristics of     patient, the quality and evolvement of CABG and valve procedures in China, (ii) build and     valid surgical risk assessment tools for Chinese population, (iii) provide databases for     clinical studies, and quality improvement initiatives.   "
67659|NCT02400112|"     The purpose of this study is to determine if local administration of vancomycin powder at the     site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to     lower infection rates in open fracture treatment and to elucidate any detrimental effects of     applying vancomycin powder at the site of open fractures.   "
67855|NCT02397564|"     The investigators will compare the efficacy of Traditional Ablative Er:YAG Versus Fractional     Ablative Er:YAG in a split scar study. The patient will receive a month treatment for 3     months. Then follow up for the next 2 months.   "
67661|NCT02400086|"     Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to     improve their respiratory function. Bacterial flora and bacterial drug resistance in the     respiratory tract have never been studied until then for this type of patient in spite of     their frequent hospital stay, their regular exposition to antibiotics and their     susceptibility to swallowing disorders due to their pathology. This study is based on a     single tracheal aspirate within the 48 first hours of the patient stay for a ventilation     check up beside any infectious context to describe the basal bacterial respiratory flora.   "
67662|NCT02400073|"     Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of     suffers. Recent literature has shown that females may be particularly susceptible to adverse     the quality of life effects, and that female obstructive sleep apnea manifests differently     than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device     has been designed specifically to treat female OSA. In this Cohort study, female patients who     are newly diagnosed with OSA will be asked to complete various questionnaires relating to     their quality of life. Patients will then use the AutoSet for Her for three months. At the     completion of the three months the questionnaires will be repeated. Before treatment and     after treatment quality of life will be compared to determine if treating female specific OSA     in these patients improves quality of life.   "
67663|NCT02400060|"     This pilot trial studies a telephone-based intervention to see if it increases adherence to     adjuvant hormonal therapy in patients with breast cancer. Increasing communication between     doctors and patients with breast cancer may help patients to better follow recommendations on     taking adjuvant hormonal treatment medication. A telephone-based intervention may help to     increase doctor-patient communication and patients' adherence to their prescribed medication.   "
67664|NCT02400047|"     Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory     care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in intraoperative     care is recommended for effective postoperative analgesia in children. However, intravenous     ketoprofen doesn't have the marketing authorization for use in children less than 15 years     old and its use is mainly justified by the absence of therapeutic alternatives. Recently,     findings from published studies suggest that dexamethasone (DXM), which is actually     recommended to prevent PONV for children at risk, at a dose of 0.1mg/kg, would have     analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (NSAI).      Main objective :      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of     postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).      Secondary objectives :      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen     (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the     consumption of rescue analgesics and the side effects in the first 24 hours after surgery.   "
67665|NCT02400034|"     Urinary incontinence is a prevalent health and quality of life concern affecting almost half     of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of     many surgeons who perform midurethral sling surgery. All patients after outpatient     midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be     discharged without a catheter. The purpose of this study is to compare two different types of     postoperative voiding trials to determine which leads to less post-operative issues, such as     urinary retention requiring catheterization. You are being asked to participate because you     are having midurethral sling surgery, either with or without vaginal prolapse repair.   "
67666|NCT02400021|"     In pregnancy, cART is considered optimal for maternal health and for preventing the emergence     of resistance that could compromise further care. In Canada, the majority of HIV-positive     pregnant women receive a PI-based cART regimen. In the past, therapy was generally deferred     until after the first trimester (if not required for maternal health) to minimize any unknown     risk of teratogenicity. However, as treatment is now started earlier in HIV infection and as     perinatal transmission rates are lowest in those with prolonged suppression of viral load     during pregnancy, women are increasingly commencing cART either before conception or earlier     in pregnancy.      Multiple reports and cohort studies provided data suggesting an association between PI-based     cART use and preterm birth, low birth weight, and small for gestational age (SGA) babies,     although conflicting data exist.      In the general population progesterone supplementation is widely used, is well tolerated, is     considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth     weight. The investigators experimental findings suggest that PI use during pregnancy is     associated with declines in progesterone levels that correlate with fetal growth, and that     progesterone supplementation can improve PI-induced fetal growth restriction. The     investigators preliminary findings in HIV+ pregnant women suggest that PI-use is associated     with declines in progesterone levels, which correlate with birth weight percentile. Since     HIV-positive women have higher rates of pre-term delivery and low birth weight that may be     magnified by the use of PIs, then progesterone supplementation could be of benefit to     neonatal health in the context of HIV-positive pregnancy.   "
67667|NCT02400008|"     Selective laryngeal bilateral reinnervation as a secondary treatment in patients with     bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids     ankylosis.      The surgical procedure is : functional reinnervation with the upper root of one phrenic     nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory     muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right     and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.      Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid     abduction, and residual dysphonia, a secondary vocal fold medialization is done by an     endoscopic approach 12 months after reinnervation (included in the protocol).      Improvement is expected in voice and breathing, without aspiration.   "
67757|NCT02398838|"     This study examined the acceptability and feasibility of using a simplified regimen of     medical abortion in the eastern and western regions of the country of Georgia. It was     hypothesized that home use of mifepristone and buccal administration of misoprostol would be     both acceptable and efficacious.   "
67758|NCT02398825|"     This study aims at evaluating the efficacy of treatment with ponatinib in patients with     chronic myeloid leukemia who are in a chronic phase and who previously received treatment     with imatinib but resulted to be resistant to it.   "
67763|NCT02398760|"     Nowadays, the research priority in low back pain area have been find subgroup of patients     with the same characteristics that might achieve better outcomes in a specific intervention.     However, even though the studies in this area have increased, questions of this nature     remaining without an adequate answer, or with limited evidence. Therefore, the investigators     propose to examine the ability of clinical tests, developed to assess alterations related to     clinical lumbar instability, to identify subgroups of patients with non specific chronic low     back pain that may have better outcomes after a motor control exercises intervention.   "
67668|NCT02399995|"     This study is being done to learn more about health related quality of life factors in people     having surgery for colorectal liver metastasis. The investigators will look at how these     factors may change over time. The information gained from this study will help the     investigators to understand the long-term effects that cancer treatments have on the health     related quality of life of patients. This information is of high value and will help doctors     talk to patients about the possible effects of their operations. While many patients live a     long time after such operations, the studies that have been done do not tell the full story     of what patients go through after surgery. This study will help us to understand cancer     treatment from the patient's perspective. It will also help cancer patients make better     decisions about their treatment options and will help them know what to expect after the     operation.   "
67669|NCT02399982|"     This study aims to utilize emerging mobile application technology, as a tool for increasing     the potency, accessibility, and efficacy of a guided self-help version of     cognitive-behavioral therapy (CBT-GSH) for binge eating. The feasibility and efficacy of the     adapted smartphone application created by Noom Inc., Noom Monitor, will be examined through a     randomized control trial comparing CBT-GSH + APP with CBT-GSH conducted at the Mount Sinai     School of Medicine's Eating and Weight Disorders Program. The investigators hypothesize that     CBT-GSH with the addition of the Noom Monitor, will be significantly more acceptable, have     greater uptake of self-monitoring, greater adherence to treatment, and greater reduction in     objective binge episodes (OBEs) than standard CBT-GSH.   "
67670|NCT02399969|"     The purpose of this study is to study acupuncture for the treatment of low back pain in the     emergency department. Current treatments for low back pain in the emergency department     generally include pills or injections of medications to treat pain and relax muscles.     However, it is known that many of these medications have risks and toxicities which may limit     their safe use in some patients. Therefore, new types of treatments are needed.      Acupuncture is an ancient form of healing that has been practiced in some form for centuries.     In modern times, acupuncture has been studied for the long-term treatment of low back pain     and some research suggests it may be effective. However, very little research has examined     the use of acupuncture for immediate pain relief in the emergency department.      This research will study a type of acupuncture called Battlefield Acupuncture (BFA).     Battlefield acupuncture was designed by a physician in the US military with the purpose of     providing immediate pain relief. It involves the placement of 5 small needles in each ear.     The needles may be removed at any time. The hypothesis of this study is that battlefield     acupuncture may improve mobility and pain of patients with low back pain in the emergency     department.   "
67671|NCT02399956|"     While the majority of women in the general population can breastfeed successfully, the     investigators have limited knowledge about the correlates and sequelae of lactation success     among women treated for pediatric malignancies. Childhood cancer treatments are known to     cause late effects that frequently involve the endocrine system. Because normal lactation is     dependent upon interplay of multiple endocrine factors, the investigators anticipate more     breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies,     thyroid disorders and obesity. In order to more fully inform clinicians and female survivors,     the study of the burden of lactation failure is needed to begin to address the impact of     pediatric cancer therapy on lactation success/failure and to examine the association of     specific endocrine disorders on lactation outcomes.   "
67672|NCT02399943|"     This is a phase 2 study (the second phase in testing a new drug or drug combination) to see     how useful the combination of two drugs, panitumumab and trametinib, are in patients with     advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).      Panitumumab is a drug that is approved by Health Canada for the treatment of advanced     colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the     protein, epidermal growth factor receptor (EGFR) from working.      Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a     mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated     protein kinase kinase (MEK) 1 and MEK2 from working.      Previous studies have shown that the combination of panitumumab and trametinib may be more     useful in KRAS, NRAS, or BRAF wild type colorectal cancer.   "
67673|NCT02399930|"     Currently, breathing rate and heart rate are checked by nursing staff manually every few     hours and entered into a patient's medical record. The investigators are doing this study to     see if a device that will automatically record breathing rate and heart rate every 15 minutes     is as accurate as the manual measurement. The investigators will also see if these     measurements, taken every 15 minutes, will help us predict adverse events more quickly and     accurately than the measurements taken every few hours.   "
67674|NCT02399917|"     The goal of this clinical research study is to find the highest tolerated dose of the     combination of lirilumab and 5-azacytidine that can be given to patients with AML or     high-risk MDS. Researchers also want to learn if the drug combination can help to control the     disease. The safety of the drug combination will also be studied.   "
67675|NCT02399904|"     This study was conducted to check the effect of California tri-pull taping method on post     stroke shoulder subluxation, prior to conduct a large randomized clinical trial this study     was conducted, and the result of the study was promising for the treatment of shoulder     subluxation.   "
67676|NCT02399891|"     Cohort study aimed at evaluating the incidence of left ventricular (LV) dysfunction after     myocardial infraction (MI) and assessing the prognostic utility of change in ejection     fraction (EF) over the initial 12 months after MI.   "
67677|NCT02399878|"     Respiratory complications represent the second most frequent type of postoperative     complications with an incidence estimated to range from 2.0% to 7.9%      It has been shown that intra-operative protective ventilation is associated with a reduced     risk of respiratory complications. The effects of intra-operative inspiratory oxygen fraction     (FiO2) remain to be investigated.      In this study, the investigators aim to investigate the association between intra-operative     FiO2 and respiratory complication as well as surgical site infection and ICU admission in     patients undergoing non-cardiothoracic surgery. The investigators primary hypothesis is that     high intra-operative FiO2 increases the risk of postoperative respiratory complications     independent of predefined risk factors.   "
67678|NCT02399865|"     Research evidence shows that there is a high prevalence of substance use among young people     in the UK. Early onset and high levels of use are associated with a range of negative     outcomes, including increased risk of later problematic use and dependence. A growing body of     research has identified family interventions to be effective in treating young people's     substance use problems. However, despite this evidence, takeup of family based approaches, at     least in the UK, has been low. A key factor appears to be the resource intensive nature of     many family interventions, making them difficult to implement and deliver in many service     settings, especially in the context of substantial cuts to drug and alcohol services for     young people (1). Another potential barrier may be the cultural adaptation of approaches     developed in the USA to a UK setting. There is growing awareness of the need to adapt     evidence-based treatments to different cultural groups and settings in order to ensure     successful implementation (2,3,4).      Following on from developmental and adaptation work, this study aims to demonstrate the     feasibility of recruiting young people to specifically developed family and network based     intervention. In addition the feasibility of training staff from existing young people     addiction services to deliver this intervention will be explored and treatment retention will     be assessed. Qualitative interviews will elicit the participants' views on the acceptability     of the intervention and their experiences of both it and the study process.   "
67679|NCT02399852|"     Study to assess changes in carotid and aortic atherosclerosis in patients being treated with     lomitapide.   "
67680|NCT02399839|"     To evaluate the outcomes of pregnancy in women treated with lomitapide.   "
67681|NCT02399826|"     This is comparison trial comparing human amniotic membrane to standard wound care for non     healing diabetic foot wounds over a 12 weeks period   "
67682|NCT02399813|"     This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of     ADXS11-001 in 31 and 24 subjects, respectively with persistent/recurrent, loco-regional or     metastatic SCCA of the anorectal canal that have received at least 1 regimen for the     treatment of advanced disease   "
67683|NCT02399800|"     Rationale: Chronic pancreatitis is a chronic inflammatory disease of the pancreas which     results in debilitating abdominal pain, decreased productivity and increased health care     costs. Endoscopic ultrasound (EUS) guided celiac plexus block (CPB) is routinely used to     treat pain related to chronic pancreatitis. While EUS guided neurolysis for pancreatic cancer     has significant efficacy, the benefit of CPB for chronic pancreatitis pain is controversial     and has not been studied in a rigorous manner.      Objective: To assess whether EUS guided celiac plexus block decreases suffering,     hospitalization, and opiate requirements related to chronic pancreatitis pain.      Population: Patients undergoing EUS at Los Angeles County Hospital for painful chronic     pancreatitis.      Methods: Patients undergoing EUS to evaluate chronic pancreatitis with a typical visual     analogue pain score >3, regular opiate use, and M ANNHEIM chronic pancreatitis score >6 will     be eligible.      Study Arms: Patients will be randomized to 1) diagnostic endoscopic ultrasound 2) endoscopic     ultrasound with celiac plexus block      Study Outcomes: The primary outcome will be a decrease in chronic pancreatitis pain assessed     by the visual analogue scale and M ANNHEIM system at 24 weeks compared to immediately prior     to the block. The ability to work and conduct normal activities, opiate medication     requirements, and a Careprep symptom assessment at 24 weeks will also be compared prior to     the block.      Analytic Plan: The projected response rate to EUS guided CPB is 52%. Given known 30% placebo     response in patients with pain related to chronic pancreatitis we anticipate that 83 patients     will need to participate to demonstrate a difference. We aim to enroll 90 patients in this     study.   "
67684|NCT02399787|"     The aim of the post doc project is investigate which genes regulate implantation in order to     analyze specific proteins and microRNA in the spent culture media with the long-term goal of     developing a non-invasive method of embryo assessment and selection. This will be achieved by     conducting a targeted NGS analysis, based on list obtained from a non-published pilot study.     When further validated by q-PCR, the expression of specific microRNAs known to influence the     final list of genes will be analyzed in the spent culture media and the protein products of     the genes recovered from the media will be quantified. The level of specific microRNAs and     proteins will be related to aneuploidy and implantation potential. If the level of specific     microRNA and/or proteins correlates with pregnancy, the study will form the basis for     developing a clinical applicable precise method of improved embryo selection and thus     improved IVF treatment.   "
67685|NCT02399774|"     Leboride is a dental support device that was developed for reducing pain during active labor.     It is made of an inert material, placed in the woman's mouth and does not disturb breathing,     talking, or any other activity expected during labor. It is a single-use device, each user     receives a new one.      This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that     improve women's breastfeeding experience, and increase breastfeeding rates.   "
67686|NCT02399761|"     Parents of newborns will be invited to test if their newborns are affected with Aromatic     L-amino Acid Decarboxylase (AADC) deficiency.   "
67687|NCT02399748|"     Prospectively follow patients with Pompe disease underwent enzyme replacement therapy.   "
67688|NCT02399735|"     The purpose of this study is to explore the safety of NK cells from Sibship in patients with     recurrent hepatocellular carcinoma after liver transplantation.   "
67689|NCT02399722|"     In surgical units negative pressure wound therapy (NPWT) is often used to facilitate wound     healing. The recommended frequency of change every third to fourth day causes an immense     workload.      The purpose of this study is to evaluate the effect of an additional polymeric membrane     interface dressing (PolyMem® WIC) as primary wound contact layer in NPWT in comparison to     NPWT alone on the number of required dressing changes until wound closure as the primary     endpoint. Secondary endpoints are: time to heal and wound associated pain.   "
67759|NCT02398812|"     The objective of this pragmatic multi-center randomized controlled trial is to test the     effectiveness of interprofessional medication assessment in older patients needing home care     due to their diseases or decreased functional capacity in primary care. The main hypothesis     is that intervention has a positive impact on functional capacity and for rational and safe     use of medicines.   "
76028|NCT02290691|"     The purpose of this study is to determine if the administration of flu vaccine using     Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory     tests of immune response.   "
67690|NCT02399709|"     Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately,     there are few smoking cessation agents and their effectiveness has been shown to be     relatively limited and is associated with potential unwanted effects. Therefore, the     discovery of new medications that can facilitate abstinence and reduce relapse to cigarette     use represents a pressing necessity. In the attempt to find molecules that could reduce     drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not     food, seeking behavior in rats. This discovery of a new therapeutic application for an     already marketed class of compounds may greatly facilitate the translation from preclinical     to clinical setting. In this project, we aim at investigating whether simvastatin is an     effective smoking cessation agent in humans.      The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial     with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin     or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo)     will be recruited through already established networks of general practitioners. The primary     outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last     month of the 3-month treatment period, defined as reported continuous abstinence from smoking     and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last     assessment will be done 6 months after the predefined quit date.      The results of this proof-of-concept study may open new perspectives in the treatment of     tobacco use and dependance.   "
67691|NCT02399696|"     Primary care patients typically do not receive adequate PTSD treatment because of their     reluctance to engage in empirically-supported treatments offered in specialty care settings.     Effective treatments for PTSD are also typically not provided in primary care. Brief     skill-based treatments offered in primary care may alleviate symptoms and prepare patients to     engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for     a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to     primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the     8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition     demonstrated significantly greater decreases in PTSD and depressive symptoms from     pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12     week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD,     averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses     revealed that the describing, non-judging, and acting with awareness facets of mindfulness     may account for decreases in PTSD. Our data support preliminary efficacy of a brief     mindfulness-based intervention for Veterans with PTSD in primary care. Further research is     needed to investigate how PC-bMP may facilitate engagement into full length     empirically-supported treatment for PTSD.   "
67692|NCT02399683|"     Mucosal immunology during helminth infection   "
67693|NCT02399670|"     The femoral-offset (FO) is one of the important perioperative parameters in THA. A     prospective cohort study was conducted between September 2010 and December 2013. All patients     with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.     Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were     excluded. Global FO was measured in each patient within 3 months before the THA and at the     second postoperative day using a standardized protocol. According to the postoperative     measurement, patients were divided into three groups: 1) the decreased FO group, where the FO     of operated side was reduced more than 5mm compared with the contralateral side, 2) the     restored FO group, where the FO of operated side was within 5mm restored compared with the     contralateral side, and 3) the increased FO group, where the FO of operated side was     increased more than 5mm compared with the contralateral side.      Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and     EQ-5D questionnaires in addition to a clinical assessment with palpation of the operated hip     and measurement of the abductor muscle strength.   "
67694|NCT02399657|"     A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant     (Ozurdex®) on hard exudates of diabetic macular edema.   "
67695|NCT02399644|"     Only to a limited extent has been compared the effectiveness of physical exercise and     psychological interventions in subjects with chronic pain. Knowledge about this is necessary     in order to compose optimal multimodal rehabilitation programs at different health care     levels. Moreover, assuming that both types of interventions have effects, these effects may     necessarily not concern the same outcome variables. Therefore it may be important to     understand to what extent the effects overlap and the extent to which the effects are     isolated to an intervention.      The overall strategic purpose of the present study is to develop effective multimodal     rehabilitation programs. In this study the effectiveness of following three interventions are     compared.        -  Group-based rehabilitation according to a concept based on an Acceptance and Commitment          Training -Stress Management Intervention (ACT-SMI)        -  Group-based rehabilitation compromised of physical exercise (Exercise).        -  Group-based discussion concerning pain and its consequences (i.e., the control group,          CON) The effectiveness is investigated with respect to long-term effects on pain and its          consequences, including perceived health and return to work / sick leave.      The overall hypothesis is that the former intervention means better long-term results because     it clearly helps the individual to process the psychological aspects of itself likely to have     long lasting effects.   "
67696|NCT02399631|"     An enhanced recovery program has been developed to provide for colon cancer patients faster     and more personalized postoperative treatment. Most of the previous studies have showed that     the efficacy of the enhanced recovery program on both subjective and objective physical     recovery of patients. However, such studies are rarely conducted in South Korea. The purpose     of this study is to evaluate the feasibility and efficacy of a postoperative enhanced     recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary     hospital in Korea.   "
67781|NCT02398526|"     This observational prospective single arm cohort study is designed to assess pain and bone     pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC)     patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition,     overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal     event (SSE), course of blood counts, and safety will be assessed.   "
67697|NCT02399618|"     Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased     incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal     Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is     prudent to consider less invasive and more convenient means of administering FMT. The     majority of reported FMT procedures have been performed with fresh or frozen stool     suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose     capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed     the need for invasive gastrointestinal procedures. However, to avoid undesirable     disintegration, those capsules containing stool suspensions must be kept frozen all the time,     which extremely limits their widespread application. The purpose of this study is to evaluate     the efficacy and safety of freeze-dried, capsulized FMT for RCDI.   "
67698|NCT02399605|"     Assess whether the application of electrical stimulation in patients undergoing subcutaneous     colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of     postoperative ileus, improving the results of morbidity and mortality, hospitalization and     health care costs.   "
67699|NCT02399592|"     The purpose of this study is to to investigate the effect of tocotrienol as a nutritional     supplement in combination with bevacizumab in patients with advanced ovarian cancer.   "
67700|NCT02399579|"     The purpose of this study is to better standardize the symptom recording of cat allergic     persons under real-life conditions. A new self-assessed, home-based symptom score will be     tested.   "
67701|NCT02399566|"     The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance     therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS).     Based on prediction of different potential benefit groups, this study may help the oncologist     to optimize and improve the maintenance therapy plan for lung adenocarcinoma.   "
67702|NCT02399553|"     The number of turf fields has experienced an important increase in public and private     facilities during the last years. This artificial surface will be predominant in any soccer     field in the next years. Among turf fields there are many different types depending on their     construction characteristics (with and without asphalted base, elastic base, rubber filling,     etc.). Officially all types of artificial turfs should have similar stability and impact     absorption characteristics. On the other hand there is a great variety of soccer-boots,     especially for youth soccer players, similar to the football stars.      Many evidences support the fact that when a person exercises many different type of     impacts-stimulus are necessary in order to stimulate bone and skeletal muscle systems.     However, it is not known yet whether this effect can be extended or shortened depending on     the type of artificial surface and soccer-boots used, or even more whether it could be more     or less dangerous and/or provoke injuries/disagreement among the users. Little information is     available in youth soccer player pointing in the same direction but still controversial.     Furthermore, bone strength do not only depends on bone mass but on bone structure and     microarchitecture. The cross sectional area, cortex thickness or trabecular density are     important aspects of bone health. There are few studies on the effect of interaction between     turf field and soccer boots on bone architecture of youth soccer players. This information is     relevant for present and future health of adolescents practicing football and for all the     organizations promoting this sport.      Due to the fact that turf fields are preferentially used by youth populations, it is     important to know the real effects of the interaction between of different type of artificial     surfaces and soccer boots on children bone mass development. Nowadays, there are no data     and/or defined guidelines that can answer those unresolved questions, thus the main aim of     the present project is to identify which turf field and soccer boots are the most adequate to     optimize the acquisitions of bone mass in children soccer players.   "
67703|NCT02399540|"     Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have     limited effects on motor recovery. Therefore, investigating new potential therapeutic     approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of     non-invasive electrical stimulation where a weak current is applied through electrodes over     the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which     can last up to one day with late LTP-like plasticity protocols- in a polarity and     site-specific manner, and (2) facilitate motor learning and stroke recovery. However, it is     unknown how the motor cortex excitability changes that follow tDCS relate to the increase in     motor learning and recovery potential. The currently upheld hypothesis is that motor learning     needs to be synchronized in time with electrical stimulation (paired stimulation), but recent     results from our lab suggest that tDCS also increases skill learning after stimulation has     ended (unpaired stimulation). If this is true, tDCS has a much larger therapeutic window and     is a more valuable clinical tool than currently believed. Therefore, the investigators want     to investigate how late LTP-like plasticity tDCS affects the increase in skill learning     normally seen with tDCS when applied 24 hours before training. The outcome of this study can     provide important guidelines on effective motor therapy during stroke rehabilitation.      Objective: Identify the effect of late LTP-like plasticity tDCS in chronic stroke patients on     skill learning 24 hours later.      Study design: Double-blinded, randomized between-subjects trials. Study population: Chronic     stroke patients. Main study parameters/endpoints: The main objective of the study is to     determine the effect of late LTP-like plasticity tDCS on skill learning 24 hours later. As a     motor learning paradigm, the investigators will use a circuit tracking task which chronic     stroke patients perform better if tDCS is applied concurrently. During this task, patients     have to trace a cursor over a circuit as fast and accurately as possible by moving a computer     mouse. Skill will be quantified by calculating a combined speed/ accuracy score and skill     improvement compared to baseline (LI; the learning index) will be compared between the sham,     conventional unpaired tDCS, conventional paired tDCS groups and the late LTP-like plasticity     tDCS groups.   "
67704|NCT02399527|"     Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the     understanding of the natural history, long-term outcomes, risk factors for morbidity and     mortality, and the relative benefit of medical therapies and procedures is limited.The goal     of this project is to better understand these diseases and improve the care of theses rare     patients. To do this, the investigators are conducting an observational study of patients     with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective     data on mortality, morbidity, treatments, and functionality as well as quality of life.   "
67705|NCT02399514|"     Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of     patients treated with RePneu coils. This monocenter prospective study investigates the effect     on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease     stages of pulmonary emphysema.      Patient's sleep will be studied in three Polysomnography measurement nights, one prior to     Coil Treatment, one six months after, and one twelve month after.      Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil     Treatment.      Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function     parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).   "
67706|NCT02399501|"     Prospective comparative study including 100 infertile patients with suspected uterine lesion.     2D ultrasound, sonohysterography , 3D ultrasound and hysteroscopy will be done to evaluate     uterine cavity.   "
67782|NCT02398513|"     The primary objective of this study is to define the pharmacokinetic of Regorafenib     administered orally as a single agent in Chinese patients with advance solid tumors.      The second objective include the evaluation of safety, tolerability, and efficacy of Chinese     patents treated with Regorafenib   "
68350|NCT02391103|"     The purposes of this study are 1) to determine whether neuromuscular electrical stimulation     (NMES) is effective in preventing loss of muscle mass and strength and 2) to observe the time     variation of MLT and strength from preoperative day to hospital discharge.   "
67707|NCT02399488|"     Continuous haemoglobin determination could improve the outcomes of several patients in risk     of bleeding during surgery. An in vivo calibration has been introduced to the device after     our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous     haemoglobin monitor has been made in various papers, although it has been compared to point     of care devices, thus introducing an error as such point of care devices although validated     for haemoglobin determination, are not as accurate as the gold standard. The validation of     the gold standard calibrated device has not been described yet.      When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy and     precision of the continuous haemoglobin monitor could be good enough to be used     interchangeably with the gold standard.   "
67708|NCT02399475|"     Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid     hormone levels, is a common diagnosis in the elderly. The purpose of this study is to examine     the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older with     persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition,     participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits:     baseline and while taking two different thyroid hormone preparations, levothyroxine and     liothyronine. The investigators will also assess physiologic responses to these two different     thyroid hormone medications to help us understand how the thyroid works in advanced age.   "
67709|NCT02399462|"     This is an open label safety and feasibility trial using Acthar® in addition to     center-specific standard therapy including plasma exchange, for treatment of post transplant     recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects will     receive Acthar® 40 units subcutaneously twice weekly for two weeks then 80 units     subcutaneously twice weekly for 24 weeks.   "
67711|NCT02399436|"     Most of the nation's serious chronic health challenges and causes of death, including     diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both     poor diets and associated disease are disproportionately common in the Appalachian counties     of eastern Kentucky, a region with stark health inequities, including elevated rates of     obesity, overweight, and premature mortality. The purpose of this pilot study is to evaluate     a multi-component intervention developed through community-based participatory research     methods for improving access to healthy foods and enhancing dietary intake in eastern     Kentucky. The intervention components evaluated in this study consist of a social marketing     campaign delivered to middle and high schools to promote healthy snacking and water     consumption, and a series of group cooking classes for adults.   "
67712|NCT02399423|"     South Asians have a much higher risk of diabetes compared to Europeans and investigators     don't know why this is. Investigators think that South Asians' capacity to store fat safely     under the skin is lower than Europeans, so they start to store fat around internal organs and     in liver and muscle, and at lower body weights than Europeans. These increased levels of     internal fat storage are thought to increase risk of diabetes.      The purpose of the study therefore is to investigate whether there are differences with     weight gain and weight loss in fat storage, fat cell function and metabolic risk factors, in     South Asians compared with Europeans. Investigators will compare South Asian and European men     at the start of the study, after they have gained about 7% body weight, and again after they     have lost 7-15% body weight (from peak weight) to see how gaining and losing weight affects     fat storage within the body and the function of fat cells. Investigators will also assess the     effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes     and heart disease.   "
67713|NCT02399410|"     The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment     consisting of perioperative combination chemotherapy with the vascular endothelial growth     factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.   "
67714|NCT02399397|"     This study aims to evaluate the influence of age and sepsis on in vivo activity of OATP1A2     using rocuronium (ROC) as a probe and evaluating the pharmacokinetics and pharmacodynamics in     ASA I-III surgical patients. Thus, adult patients without sepsis (control group, n= 12),     adult patients with sepsis (sepsis group, n= 12) and elderly patients without sepsis (elderly     group, n= 12), all submitted to small to medium-sized surgeries who were induced with     individual doses of rocuronium, fentanyl and propofol are being investigated.   "
67715|NCT02399384|"     The investigators propose to correlate 1) cardiac MRI pericardial adipose volume, 2) the     presence of pericardial monocytes and 3) circulating immune biomarkers in persons with and     without CHD and HIV infection compared to seronegative controls with known CHD. The     investigators aim to test the hypothesis that higher amounts of pericardial fat deposition     and increased presence of monocytes within this adipose tissue are associated with underlying     coronary artery disease in persons with HIV infection as measured by cardiac MRI.   "
67716|NCT02399371|"     This phase II trial studies how well pembrolizumab works in treating patients with malignant     mesothelioma, a cancer of the linings around the lungs (pleura) or abdomen (peritoneum).     Monoclonal antibodies, such as pembrolizumab, work by blocking a protein called programmed     cell death 1 (PD-1) which may stimulate an immune response and kill tumor cells.   "
67717|NCT02399358|"     Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize     screening of hyponatremia development in the follow up period.   "
67718|NCT02399345|"     This open-label study will evaluate the safety and efficacy of co-formulated     ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or     without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic     HCV-genotype 1 infection without cirrhosis   "
67760|NCT02398799|"     The aim of this randomized controlled trial was to evaluate the effects of an integrated dyad     care program with education and psychosocial support to patients with chronic heart failure     and their partners during a post-discharge period after acute deterioration of heart failure.      Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care or     a psycho-education intervention delivered in three modules through nurse-led face-to-face     counseling, computer-based education and other written teaching materials to assist dyads     develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24     months to assess perceived control, perceived health, depressive symptoms, self-care,     knowledge, caregiver burden and health care utilization.   "
67719|NCT02399332|"     This project is an initiative to bring physicians, nurses, community pharmacists and patients     together in collaborative planning in the management of diabetes, which aligns with the     collaborative, team based aspects of family medicine as a community based discipline. Alberta     funds both physicians and community pharmacists to complete a comprehensive assessment and     plan for patients with qualifying medical conditions. Our research hypothesis is that a     collaborative approach between healthcare providers involved in delivering care will improve     individual patient outcomes with the primary outcome being improved glycemic control. Health     care utilization and medication adherence will also be assessed. This project will compare     the results of comprehensive annual health care plans implemented over a period of twelve     months with or without involvement from community pharmacists. It is hypothesized that     involvement of community pharmacists and their collaboration with physicians will lead to     improved outcomes.   "
67720|NCT02399319|"     The purpose of this study is to compare subcutaneous internal fixation and open plating of     the symphysis in patients with a disruption of the symphysis requiring stabilization.   "
67721|NCT02399306|"     This is a randomized, prospective, multicenter study. The aim of this study was to compare     the changes of body weight,survival,toxicity,quality of life and opportunistic infection     frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after     chemoradiotherapy with or without enteral nutrition therapy.   "
67722|NCT02399293|"     Investigates computer based cognitive rehabilitation and training using the N-back task with     a Visual Search task as an active control. The overall purpose is to provide (further)     evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of     convergence and divergence between patients with acquired brain injury and non-impaired     subjects.   "
67723|NCT02399280|"     The purpose of the present study is to evaluate the effect of consuming higher caloric intake     at lunch in contrast to dinner on weight loss of obese and overweight female adults when they     are in a multidisciplinary weight loss plan .   "
67724|NCT02399267|"     The requirement for invasive mechanical ventilation is a defining feature of critical     illness. Liberation or weaning is the process during which the work of breathing is     transferred from the ventilator back to the patient. Approximately 40% of the time spent on     mechanical ventilation is dedicated to weaning. Limiting the duration of invasive ventilation     has been identified as a key research priority in critical care. Studies support the use of     screening protocols (once daily vs. usual care) to identify weaning candidates and the     conduct of tests of patient's ability to breathe spontaneously (SBTs). While once daily     screening is the current standard of care in national intensive care units (ICUs), it is     poorly aligned with the 24/7 ICU care environment wherein a critically ill patients' status     can change from hour to hour. Only one large trial has compared alternative SBT techniques     [T-piece vs PS (Pressure Support)]. No trial has compared a strategy of more frequent     screening to once daily screening or alternative SBT techniques. The presence of respiratory     therapists (RTs) 24/7 in North American ICUs presents a unique opportunity to screen more     frequently, conduct more frequent SBTs, and determine the optimal strategy to liberate     critically ill adults from invasive ventilation.      The investigators propose to conduct a pilot randomized trial in 100 critically ill adults     comparing 'once daily' screening to 'at least twice daily' screening and PS vs. T-piece SBTs     in 12 Canadian ICUs. In the proposed trial, the investigators will (i) assess their ability     to recruit critically ill adults who can breathe spontaneously or initiate breaths on one of     several commonly used modes of ventilation into the trial, (ii) evaluate clinician's ability     to implement the trial as designed, (iii) assess current practices in sedation, analgesia and     delirium management and timing of patient mobilization prior to conducting screening     assessments, (iv) identify barriers (clinician, institutional) to enrolling patients, (v)     characterize trial participants based on weaning difficulty, and (vi) obtain preliminary     estimates of the impact of the alternative screening and SBT strategies on clinically     important outcomes.   "
67725|NCT02399254|"     Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical     activity in the home and community settings is less clear. It may take a longer time for this     increase in physical activity to occur. It has been stated in an editorial that it takes 3     months to train the muscles but 6 months to train the brain. The Investigators will first     evaluate the change in physical activity following pulmonary rehabilitation using     state-of-the-science motion detectors, then Investigators will follow the trajectory of     physical activity over the next several months.   "
67726|NCT02399241|"     Lung Health research study (Development of a predictive model) - To determine whether the     I-neb breathing parameters (flow data) can act as a surrogate marker for lung function     (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung     function in cystic fibrosis patients.   "
67727|NCT02399228|"     The initial proposed clinical study will be conducted in adult head and neck cancer subjects.     This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and     tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care.     Santalis believes that the proposed study is a prudent and appropriate approach to     investigate the potential of their product to prevent or improve oral mucositis symptoms     commonly seen in subjects undergoing radiotherapy with or without chemotherapy.   "
67728|NCT02399215|"     This phase II trial studies how well nintedanib works in treating patients with     neuroendocrine tumors that have spread from where they started to nearby tissue or lymph     nodes (locally advanced) or have spread from the primary site (place where they started) to     other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by     slowing or stopping a certain type of receptor called vascular endothelial growth factor     receptor (VEGFR) from attaching to its target. This may stop the growth of neuroendocrine     tumors by blocking the growth of new blood vessels necessary for tumor growth.   "
67729|NCT02399202|"     To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects     with various degrees of impaired renal function.   "
67730|NCT02399189|"     The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R     followed by autologous stem cells transplantation in newly-diagnosed primary central nervous     system lymphoma.   "
67731|NCT02399176|"     The study measures change in bone mineral density by the DEXA scan before and two or more     years after beginning ten minutes of daily yoga designed to put pressure on the spine, hips     and femur.   "
67732|NCT02399163|"     The study will evaluate and compare the potential anti-caries efficacy of a test regimen:     placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily     use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to     remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness     Recovery (%SMHR).      This will be a single center, randomized, laboratory analyst blinded, placebo, four     treatment, cross-over study in healthy participants. Participants will be assessed at     baseline and at the beginning and end of each treatment visit to monitor clinical efficacy     and safety.   "
67733|NCT02399150|"     Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain     is a subjective measure, and serious causes needing surgical intervention do not always meet     the clinical picture. Biomarkers measuring the individual stress or pain level may aid in     identifying surgical emergencies, but there are many influencing factors that have to be     taken into account.      Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility     in measuring pain, and to evaluate potential influencing or confounding factors.      Design: Prospective observational study in 200 patients presenting to the emergency     department with acute abdominal pain.      Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the     Hôpital Universitaire Pitié-Salpétrière, Paris, France.      Study population: 200 patients presenting to the ED with acute abdomen      Eligibility criteria:        -  Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years        -  Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance      Procedure:      Patients presenting to the ED with acute abdominal pain will be included after informed     consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and     baseline data assessed. All diagnostic procedures results and diagnosis made by the treating     physicians as well as initiated treatment will be recorded Final diagnosis and outcome will     be assessed by 2-week-telephone interview.      Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA     will be measured as potential biomarkers, as a control value, cortisol will be obtained.     Other biomarkers will be in consideration, depending upon availability and financial aspects.      Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical     Practice will be adhered to throughout this trial.      Sample size considerations: The number of patients of this pilote study is based on the     estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.      Significance of the study: If a biomarker is found that safely discriminates between surgical     urgency and harmless abdominal pain, this will spare radiologic exposure in often young     patients and will aid in optimized allocation of health care resources.   "
67734|NCT02399137|"     The purpose of this study is to determine whether the combination of MM-141 plus     nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone     based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients     with high serum levels of free IGF-1.   "
67735|NCT02399124|"     This experiment is designed for post marketing data collection of a cryosurgical system     [PROSENSE™ of IceCure Medical], for the treatment of renal cell carcinoma (RCC).   "
67736|NCT02399111|"     The purpose of this research study is to investigate if a new negative pressure incision     (surgical cut) management system, could reduce the occurrence of groin wound infections after     vascular surgery. This is a single use, sterile dressing that is applied to the patient's     skin. It has an attached battery-powered unit that provides negative pressure (a vacuum     environment) to the dressing and a disposable canister for the collection of wound fluids.     The patient is being asked to participate in this study because the patient is planning to     have a vascular surgery procedure that involves groin incision.   "
67737|NCT02399098|"     Focusing attention is pertinent to the performance of closed self-paced motor tasks. The     following study will examine the effectiveness of internal and external focus of attention     instructions on the performance of a dart throwing task under rested and fatigue (after     performing intense exercise) conditions. As well as the relationship between attentional     focus instructions and gaze behavior under these two conditions.   "
67738|NCT02399085|"     This is an open-label, multicentre study to characterize the safety and efficacy of the human     anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with     relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no     more than three prior systemic regimens and who are not eligible for high dose chemotherapy     (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.   "
67739|NCT02399072|"     This study seeks to better characterize relationships between visual function and the     progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration     (AMD). The study also will generate new information on the relationship between genetics and     GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200     participants with GA secondary to AMD. The study visits are scheduled to occur every 6     months. The anticipated duration of the study is up to 60 months.   "
67740|NCT02399059|"     Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads     to an immunocompromised situation, leaving unattended the neoplasm. It has been described     that SSI may result in a worse oncologic outcome.   "
67741|NCT02399046|"     A clinical trial of total knee system used in Primary Total Knee Arthroplasty in China.   "
67742|NCT02399033|"     Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of     recurrence in patients with hepatocellular carcinoma after hepatectomy.      Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group     Clinical Trial. Patients will be randomly assigned to Xihuang Capsules group or the control     group by the proportion of 2: 1.      The total sample size: 1000 cases. Study Process: The study is divided into three phases: the     screening phase, treatment phase, follow-up phase.To complete screening in two weeks,     patients who fit the criteria were randomly assigned to Xihuang Capsules group or the control     group.In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules     (2g,bid), Continuously taking to cancer recurrence or death.Control group was not received     Xihuang Capsules. In the first month to three years after treatment, Conducting visits for     once every three months,to evaluate the efficacy and safety with hepatocellular carcinoma     recurrence rate in the three years after hepatectomy as the primary outcome. When entering     the follow-up phase, Keeping in touch with patients withdrew from the study for a clinic or     telephone follow-up every three months.      From signing informed consent till the end of the study, inspecting the adverse events and     concomitant medications for all subjects in each visit.   "
67743|NCT02399020|"     33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of     Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the     intervention. Main outcome was improvement in social cognition according to specific measures     of facial emotion identification, Theory of Mind, attributional bias, social cognitive     accuracy and metacognitive overconfidence.   "
67744|NCT02399007|"     A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.   "
67745|NCT02398994|"     This multi-center randomized controlled trial evaluates if the addition of intravenous     immunoglobulin to standard treatment of corticosteroids improves outcome in children and     adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Half of     participants will receive corticosteroids alone, whilst the other half will receive     corticosteroids plus intravenous immunoglobulin.   "
67856|NCT02397551|"     To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles     triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with     three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of     ovum pickup.   "
67746|NCT02398981|"     In the developed world critical illness is routinely treated in an intensive care unit (ICU)     by highly specialized physicians, nurses and support staff. This model of intensive care is     spreading rapidly to low and middle income countries and as it spreads, challenges and     limitations to this model arise. In resource-poor settings, inadequate human resources,     training, and equipment all present barriers to safe and effective use of life-saving     procedures. The advances in medical informatics and human factors engineering have provided     tremendous opportunity for novel and user-friendly clinical decision support (CDS) tools that     can be applied in a complex and busy hospital setting. Real-time data feeds and standardized     patient care tasks in a simulated acute care environment have been proven to have a     significant advantage of a novel interface (compared to a conventional) in reducing provider     cognitive load and errors. Currently researchers within the investigator's research group     have developed and are pilot testing a simple electronic decision support tool: CERTAIN     (Checklist for Early Recognition and Treatment of Acute Illness). This tool has been     successfully tested and validated in simulated settings and is being implemented as pilot     study in 18 countries. Worldwide infant and early childhood mortality continues to be very     high partly due to the inability to recognize and respond aggressively to critical illnesses.     Investigators expect that adaptation of the algorithms from CERTAIN has potential to be a     powerful tool to improve on the medical care of children in developing countries.     Investigators aim in this project is 1) to develop a pediatric adaptation of CERTAIN     (CERTAINp) and 2) to implement it into clinical practice in resource-poor settings and     evaluate the impact of the tool on the processes and patient outcomes.   "
67747|NCT02398968|"     Recurrent upper respiratory infections ( RURTIs) are common in school aged children. An     adequate iron status might reduce their prevalence. The aim of the study is to assess the     percentage and type of RURTIs in Egyptian school children, assessing the percentage of iron     deficiency anemia (IDA) and the effect of iron supplementation on the recurrence and severity     of upper respiratory tract infections .   "
67748|NCT02398955|"     Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd.,     Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer     licensed for the treatment of de novo coronary lesions. However no data regarding the     efficacy and safety of this stent in an all-comers patient population treated with     percutaneus coronary interventions (PCI) have been published so far. In this registry the     investigators aimed to collect clinical and angiographic information about an extensive     all-comers employ of this novel stent.   "
67749|NCT02398942|"     Aim:      The aim of this study is to analyze the clinical and radiological outcomes of patients with a     proximal pole fracture of the scaphoid      Primary null hypothesis:      There are no factors associated with nonunion of a proximal pole fracture of the scaphoid.      Secondary null hypothesis:      Patients with an acute proximal pole fracture of the scaphoid have QuickDASH (Disabilities of     the Arm, Shoulder, and Hand) scores at or above the population norm (a score of 13 in the     Norway and 10.9 in the United States), 2 to 6 months after injury.   "
67750|NCT02398929|"     This is an open-label, placebo run-in study to investigate the genetic and biomedical     predictors of blood pressure response to bisoprolol. After informed consent is obtained,     subjects will be withdrawn from previous antihypertensive therapy and given placebo for at     least 2 weeks. Compliance will be assessed using pill counting, and any subject will a     compliance less than 80% during the placebo run-in period will be excluded from the study.     Bisoprolol 2.5 mg will be given once daily for 6 weeks. At baseline and after 6 weeks on     bisoprolol 2.5 mg the clinic sitting blood pressure, 24-hour ambulatory blood pressure (if     the patient is willing to do this), clinical characteristics and biochemical profile will be     measured. Central aortic blood pressure will be measured with the A-PULSE device at baseline     and after 6 weeks treatment.      After completing 6 weeks treatment with bisoprolol 2.5 mg daily, the patient will continue     treatment with bisoprolol for a total of 24 weeks unless there is any adverse event that     requires discontinuation of bisoprolol.   "
67751|NCT02398916|"     Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic     procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The     procedure usually performed in the outpatient setting under local anesthesia. However, it     could be associated with significant pain and anxiety.      The aim of this study is to examine the effects of listening to music during the procedure in     reducing pain and anxiety.   "
67752|NCT02398903|"     The aim of our study is to assess the concentrations of different oral contraceptive agents     in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve     gastrectomy) in order to study the role of the surgery and the role of body weight on drug     concentrations, and to compare these concentrations with those of normal-weight women.   "
67753|NCT02398890|"     Purpose: The overall prognosis of oncology patients admitted to intensive care has improved     greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality     in intensive care, more and more patients returning oncological circuit for the continuation     of treatment of the underlying disease The existence of sequelae after the ICU (Intensive     Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation     of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution     without tumor progression. However, no studies have evaluated the effects of resuscitation on     subsequent cancer treatment strategies. It would thus become better appreciate the long-term     oncology patients discharged alive from the hospital after a stay in intensive care.      Main purpose of research :      Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors,     after an intensive care stay for other reason than elective surgery monitoring or securing an     invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by     the treating oncologist and classified total, partial or absent from that defined before or     during the ICU stay      Secondary objective of the research :      Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.      Evaluate survival, lifestyle and physical and psychological effects of these patients after     discharge from the hospital over a period of one year. It is understood that all these     secondary endpoints will interfere with the existence of an evolutionary neoplasia not only     with the ICU stay. They will therefore be interpreted with caution.      Study Type: observational Study Design: Prognostic study of routine care, national,     prospective, cohort type    "
67765|NCT02398734|"     SONOBIRDIE Trial is a randomized, single-blind, sham-controlled study designed for a     demonstration of the safety and effectiveness of sonolysis (continual transcranial Doppler     monitoring) in reduction of risk of stroke or transient ischemic attack (TIA), brain     infarctions and cognitive decline using a 2-MHz diagnostic probe with a maximal diagnostic     energy on the reduction of risk of brain infarctions by the activation of endogenous     fibrinolytic system during carotid endarterectomy (CEA) in patients with ≥ 70% symptomatic or     asymptomatic internal carotid artery stenosis.      The sample size is based on an expected 2.5% reduction of stroke or TIA during the 30-day     postoperative period in the sonolysis group (estimated prevalence, 1.5 %) compared to the     control group (estimated prevalence, 4 %). Pre-study calculations showed that a minimum of     704 patients in each group is needed to reach a significant difference with an alpha value of     0.05 (two-tailed) and a beta value of 0.8 assuming that 10 % would be lost to follow-up or     refuse to participate in the study.      Consecutive patients will be assigned to the sonolysis or control group by a     computer-generated 1:1 randomization. In patients randomized into sonolysis group, middle     cerebral artery segment in a depth of 55 mm will be continuously monitored during     intervention using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic     energy.      In patients randomized into control group, the transcranial Doppler probe will be fixed in a     required position using a special helmet as in sonolysis group patients, but middle cerebral     artery segment in a depth of 55 mm will be only localized using a diagnostic 2-MHz     transcranial Doppler probe with a maximal diagnostic energy and the TCD monitoring will be     stopped afterwards.      Confirmation of the investigators hypothesis that sonothrombolysis is able to activate     endogenous fibrinolytic system during CEA with consecutive reduction of stroke or TIA, and     the number and volume of brain infarcts, can lead to the increase of the safety of CEA in     patients with internal carotid artery stenosis. The investigators can presume that up to 50%     of patients indicated for CEA can be treated using these methods in the future.   "
67766|NCT02398721|"     Ideally randomized controlled trials should be carried out to compare the cost-effectiveness     between FNAC and watchful waiting but such studies are very difficult to conduct in practice     because they require following up very large number of subjects for a long period of time.      The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference     (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to     determine the cost-effectiveness of two strategies in managing small incidental thyroid     nodules for the Chinese population in Hong Kong.   "
67767|NCT02398708|"     The purpose of this study is to examine the gut bacteria, levels of peripheral blood     inflammation markers, and symptoms in patients with and without chronic graft-versus-host     disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The     hypothesis is that individuals with cGVHD will have lower levels of microbial diversity,     higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels     of symptoms than individuals without cGVHD.   "
67768|NCT02398695|"     The fact that dental caries remains a major public health problem mandates that oral-health     researchers explore new strategies for assessment of caries risk, as well as for caries     prevention and management. Dental caries occurs when acids produced by bacterial glycolysis     of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries     research has been on identifying and characterizing acid-generating bacteria and the     mechanisms of acid resistance. The purpose of this study is to investigate over time the     relationship between alkali production and caries.   "
67769|NCT02398682|"     The study pilots an outreach service for Acute kidney injury (AKI) patients, based on     electronic alerts. Using the alerts we will contact the primary clinician caring for the     patient with AKI in the Intervention group. The study has a control group of patients     receiving good standard care, but without Outreach. The aim is to reduce morbidity and     mortality in the syndrome, and also to reduce healthcare costs.   "
67770|NCT02398669|"     Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose     of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.   "
67783|NCT02398500|"     The purpose of this first-in-human study is to evaluate the safety and tolerability of single     ascending doses of LMG324 to determine the maximum tolerated dose (MTD) in neovascular     age-related macular degeneration (nvAMD) subjects. Enrollment will be expanded at a safe and     tolerated dose in treatment naïve nvAMD subjects to compare a single intravitreal (IVT) dose     of LMG324 to ranibizumab 0.5 mg administered every 4 weeks for change from baseline in     best-corrected visual acuity (BCVA) at Week 12 (Day 85).   "
67784|NCT02398487|"     This is a pilot study to compare efficiency and tolerability of a personal vaporizers (PV)     new generation electronic cigarette loaded with nicotine e-liquid with cigalike new     generation electronic cigarette loaded with nicotine and usual smoking habits, in a group of     well characterized regular smokers unwilling to quit.   "
67771|NCT02398656|"     This trial will enroll patients that have been diagnosed with a transient ischemic attack     (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a     minor stroke faces the possibility of long-term disability and even death, regardless of     treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or     worsen over the hours or days immediately following a stroke. TEMPO-2 is a minor stroke trial     for patients presenting within 12 hours of their symptom onset. Patients will be randomized     to TNK-tPA or standard of care. In the intervention group TNK-tPA is given as a single,     intravenous bolus (0.25mg/Kg) immediately upon randomization. Maximum dose 50mg. The control     group will receive antiplatelet agent(s) as decided by the treating physician. Antiplatelet     agent(s) choice will be at the treating physician's discretion.      TEMPO-2 Coordinating Centre is located in Calgary, AB, Canada. There will be approximately 50     sites participating worldwide.      Dr. Shelagh Coutts is the Principal Investigator.   "
67772|NCT02398643|"     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations     result in frequent, prolonged hospitalizations. While originally considered a disease     specific to the lung, data has shown that COPD is associated with substantial cardiovascular     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with     stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown;     however, it may be due to chronic inflammation which is exacerbated with a flare-up of the     disease, and/or chronic inactivity which is similarly worsened with bed-rest during a     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.     Disease management programs, such as pulmonary rehabilitation and patient self-management     education, are part of guideline therapy for COPD; however, these are not regularly     implemented following a hospitalization, and how these interventions affect patient outcomes,     behavior, physical activity, inflammation and CV risk have not been well studied. The     proposed long-term project will examine how early referral to chronic disease management     programs after hospital discharge, affect patient outcomes. This study will provide     invaluable information about outpatient management for a disease which has a tremendous     impact on healthcare.   "
67773|NCT02398630|"     Abstract:      Recent advances in reproductive medicine have generated a demand for more accurate imaging     methods for identifying the specific cause of female infertility and other gynecologic     disorders. Virtual hysterosalpingography is an emerging modality in which aspects of the     established technique of hysterosalpingography are combined with the cutting-edge technology     of multidetector computed tomography (CT) to allow a comprehensive and highly accurate     evaluation of both the female reproductive system and the pelvic anatomy generally. Unlike     ultrasonography (US) and magnetic resonance (MR) imaging, multidetector CT is capable of     depicting both the external and internal surfaces of the uterus, fallopian tubes, and other     pelvic organs, providing high-resolution data that are suitable for two- and     three-dimensional reconstructions and virtual endoscopic views. Thus, virtual     hysterosalpingography may prove to be superior to other noninvasive modalities for evaluating     tubal patency. Moreover, in comparison with conventional hysterosalpingography, which may     involve cervical clamping, virtual hysterosalpingography is painless. Because of the health     risks associated with ionizing radiation, the use of another modality (eg, MR imaging, US)     may be preferred if the presence of a focal uterine lesion is strongly suspected. However,     virtual hysterosalpingography with multidetector CT may provide a diagnostic advantage in     complex cases.   "
67774|NCT02398617|"     Heart failure is a chronic and frequently terminal illness associated with poor quality of     life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent     guideline updates have highlighted the need for improved focus on end-of-life and palliative     care of advanced heart failure patients, in whom symptom burden can be high and treatment     options are often limited. The aims of this study are to evaluate the feasibility of     implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive     care intervention concerning multiple domains of end-of-life care not often included in     regular, outpatient clinic visits.   "
67775|NCT02398604|"     This study is intended to evaluate the safety and feasibility of intramyocardial injection of     allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA)     surgery for hypoplastic left heart syndrome (HLHS) pediatric patients.   "
67776|NCT02398591|"     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of     three dosages (250, 500, and 1000 milligram [mg], or maximum tolerated dose [MTD]) of JNJ     53718678 when administered as single dose in fasting conditions in healthy Japanese adult     participants in 3 cohorts.   "
67777|NCT02398578|"     Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment     of urgency and frequency with or without urge incontinence caused by an overactive bladder.   "
67778|NCT02398565|"     We will examine the outcome of ventral hernia repair with subsequent pregnancy   "
67779|NCT02398552|"     Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the     standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule     was reported with a high rate of dose reduction and dose discontinuation because of the     safety profile. So investigators conducte this randomized, multi-center phase II study to     determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the     same efficacy in terms of progression-free survival, objective response, and overall     survival, while reducing drug-related toxicity.   "
67780|NCT02398539|"     This protocol describes a randomized, two arm clinical trial comparing two topical treatments     in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are     randomized to either group 1or group 2 treatments:      Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at     the discretion of the investigator or if there is resolution of the of the hypergranulation     tissue.   "
67807|NCT02398188|"     This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to     subcutaneous fat in non-obese subjects.   "
67785|NCT02398474|"     Iliac crest bone graft harvest is associated with acute pain that can lead to chronic     postoperative pain. Local anesthetic infiltration and regional anesthesia could be of     interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the     associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration     of the iliac crest is associated with a pain reduction compare with placebo.      Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative     analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane     block) has been recently described. Considering the nerves trajectories, the TFP block is     probably anatomically the most appropriate block for analgesia after iliac crest bone graft     harvest.      The aim of this study is therefore to assess the benefit of an ultrasound TFP block for     analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration     Design is prospective, randomized, double blind, controlled study   "
67786|NCT02398461|"     This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled,     dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome     will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.   "
67787|NCT02398448|"     The purpose of this study is to determine whether defined and limited changes in in vitro     dissolution impact the in vivo pharmacokinetics (PK) and relative bioavailability of     allopurinol and the active metabolite oxypurinol.   "
67788|NCT02398435|"     The objective of this study is to assess safety, tolerability and early signs of efficacy of     the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic     auto-inflammatory disorder for which treatment remains empirical.      This disease is characterized by a daily spiking fever, arthralgia / arthritis, and skin     rashes with frequent components of sore throat, lymphadenopathies and neutrophilic     leukocytosis. The etiology is unknown. In addition to the above-mentioned clinical features,     the diagnosis includes some laboratory components that reflect the systemic inflammation:     high erythro-sedimentation rate, C-reactive protein, high serum ferritin and high levels of     interleukin 18 (IL-18).      Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein     (IL-18BP). This investigational drug was tested in healthy volunteers, psoriasis and     rheumatoid arthritis patients in phase I studies. It demonstrated good safety and     tolerability profile with only mild adverse events in the injection site.   "
67789|NCT02398422|"     A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM)     will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness     of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and     behavior regulation in the classroom. The LPP is designed as a neural exercise to reduce     auditory hypersensitivities, to improve auditory processing of speech, and to improve     behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural     regulation of the middle ear structures to rehabilitate and to normalize the acoustic     transfer function of the middle ear structures. The current study is being conducted to     evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning     challenged young people and will use objective measures to evaluate changes in acoustic     transfer function of the middle ears structures, auditory processing skills, physiological     state regulation, sensory symptoms, and academic pre and post testing.   "
67790|NCT02398409|"     The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention     (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also     determining it's cost effectiveness in the stroke and traumatic brain injury (TBI)     populations.   "
67791|NCT02398396|"     This study will be an open label, exploratory immunogenicity study conducted by the Oxford     Vaccine Group, University of Oxford. This study will investigate the breadth of protective     activity of serum anti-FHbp antibody responses of adults immunized with 4CMenB (Bexsero®)     vaccine as well as investigating the nature of the B-cell and T-cell responses induced by     vaccination.      The investigators aim to enroll 15 to 20 healthy adults aged 18 to 60, who will be immunized     with two doses of 4CMenB (Bexsero®) two months apart according to the licensed schedule.     Blood samples will be obtained at baseline and after each dose of vaccine.   "
67792|NCT02398383|"     This project is designed to begin to characterize the abnormalities of glucagon secretion in     subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance.     Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related     diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal     tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12     months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.   "
67793|NCT02398370|"     Prospective, open-label, non-randomized, study to be conducted at a single center. Ten     subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells     (PMD-MSCs) into the penis for the treatment of mild to moderate erectile dysfunction. Follow     up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be     evaluated for re-injection beginning at 3 months. Eligibility is determined by the clinician     based on patient reported treatment satisfaction.   "
67794|NCT02398357|"     To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic     patients with portal vein thrombosis and to explore whether it can decrease the short-term     rebleeding rate.   "
67808|NCT02398175|"     The present study predicts that concomitant chest injuries in polytraumatized pediatric     patients are a potential source of substantial morbidity and mortality.   "
67809|NCT02398162|"     This is an observational study of the natural immune response to scrub typhus in patients     recruited from Chiangrai Prachanukroh Hospital, N-Thailand. Febrile patients with a positive     IgM rapid diagnostic test will be asked if they wish to take part in a study to improve the     understanding of how the body responds to scrub typhus. Blood samples will be collected from     each participant (STP, n=60) at baseline (the day of presentation to hospital), 2 weeks     later in hospital, 12 weeks after baseline at the clinic visit and 1 year later. Data on     clinical presentation and relapses will be recorded. Control subjects are scrub typhus     exposed patients from a rural village in the caption area of Prachanukroh Hospital (STE,     n=80; approx. 40 children and 40 adults), and healthy adults blood donors from Bangkok (STH     n=30) - these subjects will be enrolled for one single blood sample. The study team will also     collect eschar swab specimens from STP group and a non-invasive specimen of the dark crust on     the day of enrollment.   "
67795|NCT02398344|"     Previous studies found important function of brain in exercises regulation on healthy and     athlete patients and this studies showed not invasive stimulation on temporal cortex brain,     induces electrics field to insula cortex, in addition modulate autonomic nervous system     cognition efforts during submaximal (maximal hight frequency) and maximal exercises. Measure     immediate effects of transcranial stimulation in bloodstream (tDCS) anodic on right and left     temporal cortex in the cardiorespiratory parameters (functional capacity, perception of     efforts and modulation of autonomic nervous system) in patients with hemiparesis due stroke.     Methods and Material: It Is a clinical trial, controlled and Double blind, using 30 adult     patients with stroke sequel, like roam. Evaluation will be hemodynamic measure data such as:     Heart Rate, Respiratory Rate, Blood Pressure, Lung Capacity Vital and assessment of the     Autonomic Nervous System, before and after anodic electro stimulation from bloodstream on     right and left temporal cortex region (T3 area) and cathodic position in contralateral     supraorbital region to anode (Fp2). On temporal cortex will be applied of 2mA during     stimulation of 20 minutes. Sham stimulation all electrodes Will be used. The stimulator turns     on for 30 seconds. Results: The primary results will analyze cardiac frequency before and     after tDCS and second step will assess the travelled distance on walking test for 6 minutes     with and without tDCS and compare these respiratory reviews results with stroke gravity.   "
67796|NCT02398331|"     The purpose of this study is to assess the impact on sexuality in women with a spinal cord     injury, twelve months after their first return to home, of a program including structured     information and education on sexuality, delivered 6 months after their first return to home.   "
67797|NCT02398318|"     Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain     stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for     refractory OCD. However, large scale randomized controlled trials to evaluate the     effectiveness of this approach are rare.   "
67912|NCT02396888|"     Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface     was applied daily with insulin and the other half with saline solution as placebo. Biopsy     specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be     evaluated as main outcome.   "
67798|NCT02398305|"     To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary     intervention (PCI) the cardiologist can choose between the femoral artery and the radial     artery. In the University Medical Center Groningen the femoral artery is commonly used. After     intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients     after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR)     wrist bandage.      The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac     catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1     hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding     complications after the procedure. In patients with radial access, the TR bandage will be     removed according to current protocol after 4 hours and additionally 1 hour observation is     required. Several cardiologists have the intention to use the radial artery more frequent for     cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease     in major bleeding complications compared to femoral access. Also there are no significant     differences in MACE. Even so there are no differences in success percentage for cardiac     catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009     Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay     unit is in case of femoral access with an ACD approximately 2 hours. For patients after     radial access post procedural admission time is approximately 5 hours. To guarantee patient     throughput, uniformity of care and more efficient use of capacity of the short-stay unit,     patients after radial access should not have a longer hospital admission time than patients     after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown     that it is safe to deflate the TR wrist band faster than four hours.      Objective of the study:      To describe the differences in safety, patient comfort and admission period after diagnostic     cardiac catheterization through radial access, between the current protocol and the protocol     of fast desufflation by Carrington et al.   "
67799|NCT02398292|"     The purpose of this study is to determine the feasibility (≥ 50% completion rate) of a 6-week     nutrition, movement, and mindfulness program for youth with recent diagnosis of psychosis.   "
67800|NCT02398279|"     This study evaluates the addition of L-Arginine to the usual regimen in the treatment of     schizophrenia in adults. As a requisite of crossover design, half of the participants started     with L-Arginine and the other half with placebo and switched over after a three weeks use and     one week of a washout period.   "
67801|NCT02398266|"     The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an     approach that can assess the total impact of the complex pathophysiologic processes in     patients with limb ischemia, particularly in those with diabetes in whom distal arterial     disease and abnormal microvascular functional responses are common. This trial is designed     to: (a) optimize methods for assessment of limb perfusion at rest and during stress using     contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able     to provide non-linear signal without destruction at medium acoustic pressures, and (b) to     test whether perfusion imaging provides incremental information on the severity of disease in     patients with peripheral artery disease.   "
67802|NCT02398253|"     The purpose of this study is to assess the effects of CBT after a successful weight loss by a     comprehensive weight loss plan on weight maintenance in obese female adults.   "
67803|NCT02398240|"     The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well     tolerated and effective in children, adolescents and young adults with all stages of newly     diagnosed Hodgkin lymphoma (HL).   "
67804|NCT02398227|"     This is a study comparing a new treatment (HOPE) to supportive therapy in the treatment of     PTSD in residents of battered women's shelters.   "
67805|NCT02398214|"     Sleep problems during infancy are associated with behavior and emotional problems, poor     language development , parental distress and mood disturbances, and overweight and obese     children. The investigators proposed that children who receive the light, activity, and sleep     training (LAST) intervention program in this study will have less parent report of problem     sleep behaviors and longer duration of nighttime sleep compared to children with no     intervention provided.   "
67806|NCT02398201|"     The purpose of this study is to gather preliminary data on whether bezafibrate can improve     cellular energy production in mitochondrial disease.      Mitochondrial diseases are rare inherited disorders that arise due to deficient energy     production within the cells of the body. Consequently, the typical clinical features arise in     organs with high energy requirements. Mitochondrial disorders exhibit highly variable     clinical effects, both between individuals and within families. Characteristic symptoms     include muscle weakness (myopathy), hearing loss, migraine, epilepsy and stroke like episodes     in addition to diabetes and heart problems. Mitochondrial disorders can therefore impact     considerably on both quality of life and life expectancy. Despite this, no proven disease     modifying treatments are available.      Pre-clinical studies have identified that several existing medications improve mitochondrial     function. Of these, bezafibrate has the best supportive data and, because it is already     licensed as a treatment for high blood fats, has a well characterised side effect profile.      The investigators will therefore conduct a feasibility study of bezafibrate in people with     mitochondrial myopathy. Ten affected participants will be recruited and will receive a     titrating course of bezafibrate three times daily for 12 weeks.   "
67810|NCT02398149|"     Upper extremity (UE) function is critical to maintaining independence. Better understanding     of UE involvement in MS will provide necessary information to prioritize the design and     selection of future interventions. The goal of the proposed project is to characterize UE     involvement in a population of community-based persons with MS across the International     Classification of Functioning, Disability & Health (ICF) domains and constructs.   "
67811|NCT02398136|"     The purpose of this study is to see whether ketamine, when given repeatedly via the nose     (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher     doses, ketamine has been used for many years as an anesthetic for medical procedures, and at     lower doses may be an effective treatment in patients with major depression and PTSD.   "
67812|NCT02398123|"     The transversus abdominis plane (TAP) block is a relatively simple technique that provides     myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in     the prevention and treatment of parietal postoperative pain.      Initial experience with ultrasound TAP block demonstrated efficacy of the echo guided     technique in different surgical procedures such as cesarean section, appendicectomy,     laparoscopic cholecystectomy, infra umbilical surgery in adult and pediatric patients.     Recently published clinical trials suggest that TAP block may represents an effective     alternative to epidural anesthesia but further studies in larger population are necessary.      Transversus-abdominis plane (TAP) block was found to increase analgesic consumption low     thoracic-epidural analgesia (TEA) in ischemic heart disease patients after abdominal     laparotomy (2). Others found comparable results between continuous transversus abdominis     plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction     after abdominal surgery(3). The TAP block affords effective analgesia with opioid sparing     effects, technical simplicity, and long duration of action. Some disadvantages include the     need for bilateral block for midline incisions and absence of effectiveness for visceral pain     (4). TAP block has been associated with good pain relief and decreased intraoperative and     postoperative opioids requirements after laparoscopic surgery (5). The analgesic efficacy of     the TAP block has been demonstrated in prospective randomized trials compared with placebo,     in different surgical procedures such as abdominal surgery, hysterectomy, retro pubic     prostatectomy, Caesarean section, laparoscopic cholecystectomy, and appendicectomy (6, 7, 8,     9, 5 and 10 respectively). All these studies have reported superiority of the TAP block in     terms of reduction in visual analogue scale scores and morphine consumption. In this study     the investigators try to compare Transversus Abdominis Plane (TAP) blocks versus caudal block     for postoperative pain control after lower abdominal surgeries in pediatrics.   "
67815|NCT02398084|"     The investigators want to understand how oral processing (chewing) of nuts affects particle     size and the presence of lipid (fat) on the cut surfaces.      The main objective of the study is to:      Measure the size of nut particles that have been chewed sufficiently to be swallowed.      The secondary objective of this study is to:      Measure any changes in lipid content due to chewing and compare it to a prediction from a     theoretical model.      The investigators have developed a theoretical model for determining the release of nutrients     from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate     the amount of lipid released from chewed almonds. The model shows that only about 10% of the     lipid is immediately released. The investigators require information on the particle size     distribution (number of particles of each size) for other chewed nuts to calculate the amount     of lipid released for other nuts. This will allow us to check the validity of our model for     other foods.   "
67816|NCT02398071|"     Most daily activities involve alternating periods of exercise and rest. If recovery is slow     following exercise it means that the next period of activity may be more difficult and the     COPD patients becomes restricted in their daily life. Therefore, the investigators are     interested to study the effectiveness and physiological effects of breathing with a PEP     device during post-exercise period and hypothesize that        1. Post-exercise breathing with PEP device will increase the rate of recovery more than          breathing without PEP device.        2. Post-exercise breathing with PEP device will not create harmful effects on          cardiopulmonary function in COPD patients.   "
67817|NCT02398058|"     This is a Phase 1b, multi-site, open-label, non-randomized clinical trial evaluating the     safety, tolerability, and pharmacokinetics of escalating doses of olaparib and trabectedin in     patients with unresectable advanced/metastatic sarcomas. Patients will continue to be treated     on this combination regimen in the absence of disease progression, intolerable toxicity or     patient's decision.   "
67818|NCT02398045|"     The study aims to pilot a new computerised cognitive behavioural therapy programme for a     small case series of adults with obsessive-compulsive disorder. The investigators hypothesise     that the findings will demonstrate improvements in symptomatology following the programme.     The programme will have longer-term aims of being rolled out over a number of IAPT services     within the NHS, reducing waiting lists and increasing therapist time.   "
67819|NCT02398032|"     Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity     in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with     isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP)     effect on these parameters.      Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area.     Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with     SAHS without previous treatment. At least 30 patients are needed.      Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three     months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months     of trial.      Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone     levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and     ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.   "
67838|NCT02397785|"     The goal of the study is to evaluate the use of a personal intravaginal, non- implanted     electrical stimulation device in the treatment of chronic pelvic pain. The investigators     propose a randomized controlled trial comparing the investigated device to a sham device. The     primary outcome is pain control using the visual analog scale and brief pain inventory (18).     Hypothesis: Subjects will report increased pain relief with the electrical stimulation device     compared to those using the sham device alone.   "
67857|NCT02397538|"     An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction     and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy     Male Subjects.   "
67820|NCT02398019|"     Patients whom require cardiopulmonary bypass (CPB) during surgery present systemic     inflammatory response syndrome (SIRS) due to blood cell activation and cytokine release to     circulation. SIRS can lead to organ dysfunction due to hemodynamic compromise (vasodilatation     plus leak syndrome) and/or cytokine mediated cell injury. Renal dysfunction is a major     adverse complication after CPB surgery. Investigators hypothesize that the use of an     increased adsorption membrane (OXIRIS®) during CPB is safe and presents low technical     complexity. The safe use of OXIRIS® will reduce both cytokine circulatory levels and     lipopolysaccharide (LPS) circulatory levels therefore decreasing SIRS and its systemic     effects specially those concerning renal function. Therefore, patients receiving (OXIRIS®)     could potentially present less postcardiac surgery acute kidney injury (pAKI), lower     intensive care unit (ICU) and hospital length of stay, and lower production of renal injury     biomarkers (cell-cycle-arrest-proteins) tissue inhibitor of metalloproteinase-2 (TIMP-2) and     insulin growth factor binding protein-7 (IGFBP-7).   "
67821|NCT02398006|"     Background: Fracture of the clavicle is common accounting for 2.6% to 4 % of all fractures,     with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80% of clavicle     fractures occur in the middle third of the clavicle. There is a lack of evidence of     randomised controlled trials assessing the best treatment of these fractures. The objective     of this study is to evaluate the effects (benefits and harms) of conservative interventions:     figure-of-eight bandage versus sling for the treating middle third clavicle fractures.     Methods/Design: this project has been designed as a single-centre, parallel-group randomised     controlled trial that will compare figure-of-eight bandage versus sling. The investigators     aim to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days) middle     third clavicle fracture. Primary outcomes will be function or disability measured by DASH     questionnaire; the secondary outcomes will be: modified UCLA score pain, treatment failure,     adverse events and numbers returning to previous activities. Data analysis: the chi-square     test will be used to analyse the results of categorical variables, and Student t-test will be     used to compare groups with respect to the numerical variables. The Student t-test is used to     compare the clinical outcome of each group at 1, 2 and 4 weeks and at 6 and 12 months after     the intervention. The significance level of 5% (alpha = 0.05) is used for all statistical     tests such that tests have a value of less than 0.05 are considered statistically     significant. Discussion: According to current evidence there is very limited evidence from     two single trials only regarding the effectiveness of different methods of conservative     interventions for treating clavicle fractures. This study is one of the first randomised     controlled trials following the CONSORT statements designed to compare two conservative     methods for treating clavicle fractures (figure-of-eight versus sling).   "
67922|NCT02396758|"     The objective of the study is to determine the optimum dose of thrombolytic and duration of     the ultrasound procedure as a treatment for acute submassive pulmonary embolism.   "
68041|NCT02395133|"     The primary objective of the study is to assess the ability of different dupilumab dose     regimens, administered as monotherapy, to maintain the treatment response achieved after 16     weeks of initial treatment with dupilumab monotherapy compared to placebo.   "
67822|NCT02397993|"     Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal     pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in     clinical routine.      The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor     marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all     three parameters was observed after surgery on the pancreas. For humans, these clinically     important data are not yet available .      It is assumed that the probability of pancreatitis with increased activity of lipase and     amylase will rise with the number of puncture procedures as well as the size of the puncture     needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could     result in a false positive assumption of malignant neoplastic pancreatic lesion.   "
67823|NCT02397980|"     The purpose of this study is to investigate if behavioral intervention for dementia     caregivers will decrease caregiver burden in caregivers of patients with dementia. This     multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be     randomized into two groups. One group consists of 40 participants who will receive behavioral     intervention and 40 who will not receive intervention (waitlist control). The waitlist     control group will be also provided the same intervention after the intervention group has     completed the intervention. The behavioral intervention consists of 90-min-session a day with     an interval of two weeks for 2 months. The primary outcome measures are the changes in scores     of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).   "
67824|NCT02397967|"     A national, multicenter, randomized, transverse clinical trial, estimating the existence of     phonological deficits in children with NF1 children compared with control children without     NF1 with the same reading level.   "
67825|NCT02397954|"     The objectives of this study are to evaluate the safety and tolerability of Zimura®     intravitreous injection in combination with anti-VEGF therapy in subjects with Idiopathic     Polypoidal Choroidal Vasculopathy (IPCV).   "
67826|NCT02397941|"     Purpose of the study is the assessment of interrectal distance and dimensions of the muscles     of the lateral abdominal wall in pregnant and non-pregnant women   "
67827|NCT02397928|"     The study is a prospective, single arm, non-randomized, open label phase II trial, designed     to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with     Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The     device is an experimental, portable, battery operated device for chronic administration of     alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by     means of surface, insulated electrode arrays.   "
67828|NCT02397915|"     The purpose of this study is to provide information on whether subjects with allergic     rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or mometasone     furoate (MF) nasal spray based on how the products feel to the subjects when administered.      This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose,     cross-over subject preference study to evaluate and compare patient preference for FF [(total     dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects with     allergic rhinitis. These two commonly used nasal sprays use different actuation systems (FF     nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will evaluate     whether this difference is reflected in the patient-assessed attributes of the two nasal     sprays. The attributes or properties which are being assessed by the subjects for these nasal     sprays include smell, taste & aftertaste, drip down the throat, run out of the nose, urge to     sneeze, and irritation.      The single-day study per subject comprises screening and all treatments and procedures.     Eligible subjects will be randomized 1:1 to a cross-over treatment schedule so that all     subjects receive both products. One group of subjects will have two sprays of FF administered     in each nostril whilst a second group will have two sprays of MF administered into each     nostril. At 30 (± 5) minutes after the first study medication treatment, the two groups will     switch. The first group will then have two sprays of MF administered into each nostril and     the second group will then have two sprays of FF administered into each nostril. After each     treatment the subject will complete two sets of attributes questionnaires ('immediate' and     'delayed'). A subject-rated 'immediate' attributes questionnaire will be completed     immediately following each treatment and a subject-rated 'delayed' attributes questionnaire     will be completed approximately 2 minutes after each treatment. Upon completion of the second     set of these two attributes questionnaires (immediate and delayed), a preference     questionnaire will be completed by the subject. In the preference questionnaire, the subject     states their preferred treatment, if any, for each of the product attributes, and finally     states their overall preferred treatment, if any.      There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after     administration of the last treatment. The study is planned to enroll about 300 subjects.   "
67852|NCT02397603|"     This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in     patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral     space.   "
67853|NCT02397590|"     A phase I clinical trial to compare the pharmacokinetics and safety of     fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and     Atorvastatin in healthy male volunteers.   "
67854|NCT02397577|"     Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air     will be followed. Normal values will be calculated data of these tests.   "
67829|NCT02397902|"     The specific aim of the proposed study is to address the efficacy of conventional full-fat     dairy products as part of the normal routine diet for improving vascular function and     reducing blood pressure in middle-aged and older adults with elevated blood pressure. The     investigators hypothesize that dietary intervention including whole milk and full-fat milk     products will induce significant decreases in systolic blood pressure and arterial stiffness.     The investigators also test the hypothesis that the reductions in blood pressure will be     associated with the corresponding decreases in arterial stiffness and/or increases in     endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity.     If our hypotheses are supported by the results, the information could be used as a basis for     recommendations for the use of whole milk and full-fat milk products in the secondary     prevention of elevated blood pressure and vascular dysfunction.   "
67830|NCT02397889|"     The purpose of this study is to study new ways to treat post-traumatic stress disorder     (PTSD). Current treatments for PTSD do not work for everyone and it can take time to     determine whether a person responds to a chosen treatment. The purpose of this study is to     see whether ketamine, when given repeatedly intravenously can produce a quick and persistent     improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an     anesthetic for medical procedures, and at lower doses may be an effective treatment in     patients with major depression and PTSD. Ketamine given for PTSD is investigational, which     means that the FDA has not yet approved the drug for treating this condition. In this study,     the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute     anesthetic effects compared to ketamine but has not been shown to treat or alleviate any     symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can     treat or alleviate PTSD symptoms thereby acting as what we call an active control.   "
71034|NCT02355977|"     To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO)     and surface and root planning (SRP) by assessing both clinical parameters and the loads of     four main periodontal pathogens in treating chronic periodontitis.   "
67831|NCT02397876|"     Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of     infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based     infant formulas are typically recommended. These formulas are expensive and not palatable.     For older patients with CM allergy, the standard of care is avoidance of all CM products. The     investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed     whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or     amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF.     Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The     investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF     and assess the degree to which taking pHWF accelerates CM tolerance.   "
67832|NCT02397863|"     This open-label, multi-center study is open to patients 1 to 18 years of age at time of     enrollment with medication resistant epilepsy.   "
67833|NCT02397850|"     There is a high risk for relapse in people suffering from depression. Studies indicate that     the continuation of an acute psychotherapeutic treatment can reduce the likelihood of     relapse. Therefore, this pilot study is aimed to investigate the feasibility of a     continuation psychotherapy over 6 months, to support people suffering from chronic forms of     depression in their daily life. The investigated continuation therapy itself includes about     one telephone call per month (therapist - patient), focussing on the integration of     strategies into the patient's daily routine. The patients receive either 30 minutes or 50     minutes phone calls. On the one hand, these phone calls are supported by a workbook for     patients containing psychoeducative elements, strategies and exercises. On the other hand,     the therapist's work is based on a manual containing several modules and strategies. Both     tools (workbook, manual) are understood as a framework, using the appropriate sections     according to the patient's needs. As a result, the patients receive a continuation treatment     which is appropriate and adapted to their individual situation.      The main purpose of this pilot study is to evaluate the feasibility of a telephone based     psychotherapeutic continuation treatment with a small sample of 20 patients suffering from     chronic depression. In case of promising results the effectiveness of this kind of treatment     is going to be investigated within a comparative trial (including face-to-face intervention,     no intervention).   "
67834|NCT02397837|"     Converging evidence suggests that patients with bipolar disorder suffer from deficits in     neurocognitive functioning that persist, despite remission of acute affective symptoms. These     impairments contribute directly to functional disability, highlighting the need for     interventions above and beyond standard treatments in order to achieve a full inter-episode     recovery. The current study aims to investigate the safety and efficacy of a dopamine agonist     (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar patients using     a placebo-controlled, adjunctive, 12-week trial design.   "
67835|NCT02397824|"     OroDental anomalies are one of the phenotypical aspects of at least 900 rare diseases or     syndromes affecting by definition less than 1 in 2000 individual within the population     (almost 25 million persons in Europe).      They are often described in association with other organs or system malformations, which is     understandable, because the same genes and signalling pathways regulate the oral cavity     formation or odontogenesis and the development of other organs. The various dental and     orofacial anomalies can be classified by type (anomalies of tooth number, shape, size,     structures of mineralized tissues, eruption, resorption, tumors; anomalies of oral mucosa;     anomalies of tongue…), by signalling pathways and by syndrome families.      These anomalies (for example hypodontia/oligodontia, amelogenesis imperfecta, dentinogenesis     imperfecta…) become increasingly identified as diagnostic and predictive traits. Not only is     it important to recognise, name appropriately and integrate these dysmorphic clues into the     patient dysmorphology analysis but it is essential to synthesize the observations and     confront them to existing data about similar orodental anomalies encountered in some of the     corresponding mutant mouse models.      Translational approaches in development and medicine, are relevant to gain understanding of     molecular events underlying clinical manifestations and to enhance diagnostic accuracy.      The aim of this study is to improve the knowledge, diagnosis and care of oral cavity     pathologies encountered in rare diseases via the identification and gathering of national and     international patient cohorts and to structure the molecular diagnosis behind these     conditions via targeted next-generation sequencing assays. Data collection is implemented on     validated accredited tools (databases) complying with the legal regulations about patient     data protection and medical record collection. All information is anonymized.      New effective diagnosis and therapeutic tools are being developed.   "
67836|NCT02397811|"     Human crossover pharmacokinetic study involving 12 subjects to determine the relative     bioavailability of astaxanthin in six commercially available oral formulations.   "
67837|NCT02397798|"     The purpose of this study is to examine whether person-centered high-intense aerobic /     strength training during five months reduces inflammation and disease activity, improve     immune cell function, and increases muscle strength, fitness and ability of the individual     independence in elderly patients with rheumatoid arthritis.   "
67839|NCT02397772|"     The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but     recent modelling has highlights that in all but low very transmission settings, the treatment     of school-aged children is unlikely to interrupt transmission, and that new treatment     strategies are required. This study seeks to answer the question: is it possible to interrupt     the transmission of STH and if so, what is the most cost-effective treatment strategy and     delivery system to achieve this goal? In this study, two paired community cluster randomised     trials in different settings in Kenya will evaluate the impact and cost-effectiveness of     annual school-based deworming, annual community-based deworming, and biannual community-based     deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to     pre-school and school-aged children, as part of a national school-based deworming programme,     or to the entire community delivered by community health workers. The primary outcome measure     is the prevalence of hookworm infection (the most common STH species), assessed by periodic     cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity     of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among     a randomly selected sub-sample of participants who will be followed longitudinally, worm     burden and proportion of eggs unfertilised. A nested process evaluation, using     semi-structured interviews, focus group discussions and a stakeholder analysis will     investigate the community acceptability, feasibility given the local and regional health     system structures and processes, and scale-up of the interventions.   "
67937|NCT02396563|"     The purpose of this study is to determine if there is a difference in the duration of the     first and second stage of labor in nulliparous women , with or without epidural analgesia.     The investigators hypothesize that the duration of the first stage of labor will be no     different in nulliparous patients, while the duration of the second stage will be longer in     patient with analgesia.   "
67840|NCT02397759|"     The subarachnoid hemorrhage (SAH) from ruptured aneurysm is a situation that is     life-threatening, which is largely dependent on the occurrence of vasospasm from the 4th day     after the bleeding. This vasopasm is responsible of clinical morbidity in 30 to 50% of     patients. It occurs in 40% of patients with severe SAH.      Despite knowing this, the clinician has no biomarker for identifying patients at risk.      The project presented is original and includes a screening method without a priori to     identify predictive biomarkers of vasospasm, likely to become therapeutic targets. In     secondary objective we will focus on the protease activity of cerebrospinal fluid (CSF) and     blood as a biomarker potential of vasoconstriction at the waning of subarachnoid hemorrhage.      This study will take place over a year prospectively. The inclusion of patients will be in     the SAR 1 Hospital of Timone. Patients with severe severe SAH by rupture requiring the     establishment of an external ventricular derivation (EVD) will be divided into two groups and     compared to one group of patients without necessitating a EVD subarachnoid hemorrhage.        -  Group 1: Patients with vasopasm        -  Group 2: Patient presenting no vasopasm Detection of vasopasm was defined using a          consensual definition. CSF samples (through EVD) and blood will be made upon arrival of          the patient in intensive care and then between the 3rd and 4th day.      As the main criterion, we will identify biomarkers of vasospasm in blood and CSF without a     priori assumption by metabolomics. Analysis will be by chromatography system coupled to a     high resolution mass spectrometer. This method does not justify effective calculation because     it is a step of generating hypotheses requiring further biological validation based on the     identified targets.      The secondary criteria, we will study in the blood and CSF association between matrix     metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm.      RESULTS: After comparative analysis of groups 1 and 2 in two phases of the study, we will     define a metabolic profile that could identify predictive biomarkers vasopasm.   "
67841|NCT02397746|"     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to     evaluate the safety and efficacy of its total hip arthroplasty (THA) European Union (EU) .     These types of studies are required by regulatory authorities for all THA devices that do not     have clinical evidence available at the time of gaining approval to market in the EU. This     study has been designed in accordance with MEDDEV 2.12/2 rev 2.   "
67842|NCT02397733|"     The main objective of this study i sto evaluate the impact of prophylactic cranial     irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of     life of small cell lung cancer patients.      In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial     irradiation using magnetic resonance imaging.   "
67843|NCT02397720|"     There are 2 Arms in this study each with 2 parts. If you are eligible, you will be assigned     to an Arm and a part when you join the study.      Arm 1: There are 2 parts : Part A (dose escalation) and Part B (dose expansion).      The goal of Part A of this clinical research study is to find the highest tolerable dose of     nivolumab and azacitidine that can be given to patients with AML. The goal of Part B of this     study is to learn if the dose found in Part A can help to control AML.      The safety of this drug combination will also be studied.      Arm 2: There are 2 parts: Part A (dose escalation) and Part B (dose expansion).      The goal of Part A of this clinical research study is to find the highest tolerable dose of     nivolumab, azacitidine, and ipilimumab that can be given to patients with AML. The goal of     Part B of this study is to learn if the dose found in Part A can help to control AML.      The safety of this drug combination will also be studied.   "
67844|NCT02397707|"     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose     of GS-9857 in adults with normal and impaired hepatic function. Adults in the healthy control     group will be matched to adults with impaired hepatic function by gender, age (± 10 years),     and body mass index (± 15%).   "
67845|NCT02397694|"     This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) +     emtricitabine/tenofovir alafenamide (FTC/TAF) fixed dose combination (FDC) versus     dolutegravir (DTG) + FTC/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This     study will also evaluate the pharmacokinetic (PK) profile of BIC, FTC and TAF.   "
67846|NCT02397681|"     The purpose of this study is to determine the effects of procedural differences during the     Valsalva maneuver and deep breathing test in autonomic nervous system testing.   "
67847|NCT02397668|"     To demonstrate the proof of principle and initial clinical safety of the CorMatrix ECM     Tricuspid Valve and increase the efficiency of the device development process by identifying     appropriate modifications to the implant procedure or the device.   "
67848|NCT02397655|"     The purpose of this multicenter study is to investigate the extra-/intra-cranial     atherosclerosis distribution pattern in chinese populations with transient ischemic attack     and ischemic stroke and analyze the influencing factors of atherosclerosis distribution     pattern.   "
67849|NCT02397642|"     To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles     triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus     1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day     of ovum pickup.   "
67850|NCT02397629|"     This is a cross sectional study to examine the relationship between serum calcium and PTHrP     and serum PSA in men referred for prostate biopsy at Wake Forest University.   "
67851|NCT02397616|"     Retrospective analysis for HRM measurements using liquid swallows and a test meal for the     presence of hiatal hernia. The investigators will correlate hernia descriptions with presence     of acidic reflux and clinical complaints.   "
67859|NCT02397512|"     This study will test the influence of lactulose of the human gut microbiota. Healthy     volunteers will ingest 50g of lactulose and donate stool samples 1 day before as well as 1-2     days and 14 days after the test. Using sequencing and metabolomics techniques the     investigators will identify changes in microbiota composition upon lactulose exposure.   "
67860|NCT02397499|"     This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to     subcutaneous fat in non-obese subjects.   "
67861|NCT02397486|"     The purpose of this study is to determine whether pentoxifylline and vitamin E are effective     in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated with     concurrent chemoradiotherapy.   "
67862|NCT02397473|"     The main purpose of this study is to evaluate the efficacy and safety of the study drug known     as LY2951742 in participants with episodic cluster headaches.   "
67863|NCT02397460|"     This is a double-blind, randomized, 4 period, crossover study in up to 30 male and female     healthy and chronic cough subjects.   "
67949|NCT02396407|"     The purpose of this study is to measure whether a combined water, sanitation, and hygiene     intervention leads to improved health of children who did not receive the intervention     themselves and who live within a close vicinity of intervention recipients.   "
67864|NCT02397447|"     The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in     patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose,     glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this     improvement is due to an improvement in insulin sensitivity and insulin secretion. The     purpose of this study is to evaluate the effect of the administration of Momordica Charantia     on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.   "
67865|NCT02397434|"     A radical cystectomy + extended pelvic lymph node dissection is considered to be the     treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this     aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors     develop a pelvic recurrence. One- and 2-years survival for patients developing a local     recurrence after cystectomy is only 8% and 3% respectively, with a median survival of <4     months. For patients with lymph node recurrence prognosis is somewhat better, but     nevertheless still disappointing with reported 1- and 2 years survival of 42% and 11%     respectively. The investigators hypothesize that an earlier implementation of external beam     radiotherapy (EBRT) i.e. in the adjuvant setting, will prevent local and lymph node     recurrence and improve disease free- and overall survival as local recurrence is linked to     the development of distant metastasis. Adjuvant EBRT was tested in a prospective randomized     trial and resulted in a 20% increase in 5-year disease free survival. Despite those     impressive results, severe intestinal toxicity rates hampered the enthusiasm to use adjuvant     EBRT, till now. In the last decade, great technological advancements in EBRT planning, such     as intensity modulated arc therapy (IMAT), and positioning have been realised. This has     resulted in a better coverage of the target volume while sparing normal tissue (mainly small     bowel) and in a more precise delivery of the EBRT. Therefore, it is desirable to reconsider     the use of adjuvant EBRT in selected MIBC patients.   "
67866|NCT02397421|"     Patients with diabetes are at increased risk of developing heart failure (HF) which can lead     to increased shortness of breath, reduced ability to exercise and in some cases premature     death as the heart becomes less efficient at pumping blood around the body. However the     treatment options for such patients remain limited.      This study will test the safety and benefits of using a new class of drug, the SGLT2     Inhibitor (Dapagliflozin), in treating HF and diabetes.      Participants will have a Magnetic Resonance Imaging (MRI) scan of the heart, to measure the     efficiency and the extent of thickening of the heart muscle before they start on treatment of     dapagliflozin, or placebo for one year. They will also do exercise testing on an exercise     bike (if capable) and a walking test plus fill in some questionnaires on how their heart     failure affects their quality of life. Participants will then continue as normal with     currently prescribed medication for their diabetes and heart failure. After a year the tests     will be repeated to determine if patients receiving Dapagliflozin benefited more than those     who weren't on the drug.      This study is funded by the European Foundation for the Study of Diabetes (EFSD)   "
67867|NCT02397408|"     This is a phase 2 study to assess the ability of 11C- and 18F-choline to detect and localize     prostate cancer within the prostate gland in patients with unfavorable intermediate to     high-risk prostate cancer (CAPRA 5-10). Secondary objectives will assess the ability of 11C-     and 18F-choline PET/MR to detect metastatic prostate cancer within pelvic lymph nodes in     patients undergoing radical prostatectomy and extended pelvic lymph node dissection, to     assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of     metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical     prostatectomy and extended pelvic lymph node dissection, to determine the agreement of 11C-     and 18F-choline PET imaging in the detection and localization of local and metastatic disease     with other imaging techniques/methods (bone scan, CT, multiparametric 1H MRI, advanced body     NaF PET/CT), and to determine the temporal distribution of 11C- and 18F-choline radiotracer     in patients. The tissue uptake, retention, and clearance will be determined. An exploratory     objective comparing regions of uptake from the 11C- and 18F-choline PET/MR and sentinel lymph     node imaging will be performed.   "
67868|NCT02397395|"     The purpose of this study is to evaluate the percentage of participants with sustained     virologic response 12 weeks after the actual end of study treatment (SVR12)   "
67869|NCT02397382|"     The purpose of this study is to evaluate the potential effects of a single dose of 200     milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe     substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in     participants with moderate to severe psoriasis.   "
67877|NCT02397278|"     This study plans to learn more about ways to treat a joint problem in the knee called     Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting     platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to     determine whether the injections lead to improvements in pain, performance of activities of     daily living, improvements is sports activities and overall function and symptoms reduction.     The investigators will compare PRP treatment to conservative therapy.   "
68344|NCT02391181|"     A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions     Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG. The Hypothesis is That     Both Iron Sucrose Injection Solutions Reveal the Same Active Substance Availability in the     Blood Circuit.   "
67870|NCT02397369|"     Tobacco use is the single most preventable cause of premature adult death globally. It is one     of the major causes of death and disease in India, accounting for nearly 0.9 million deaths     every year.      Bombay Electric Supply and Transport (BEST), one of the biggest public transport undertaking     in Mumbai City, has imposed a ban on tobacco use in public transport buses and under Motor     Vehicle Act has empowered the drivers and bus conductors to take suitable action against     commuters found to be using tobacco. However in addition to commuters using tobacco in the     BEST premises, large number of bus drivers and conductors are known to use tobacco on the     job. There are various approaches to a tobacco cessation programme, like behavioural therapy,     pharmacotherapy, providing self help material, telephone counseling, quit lines etc.      Hence in terms of the workplace environment, understanding the factors leading to tobacco use     maintenance and the effective approaches for cessation is of critical importance for     formulating workplace tobacco prevention and cessation interventions that are applicable to     transport work employee settings. The success of these methods needs to be comparatively     evaluated among the different forms of tobacco users. Hence, the present study will be     undertaken with the following objectives:   "
67871|NCT02397356|"     Ketamine has been administrated via the intravenous, intramuscular, subcutaneous, rectal,     oral, transdermal, intranasal, sublingual, transmucosal, epidural, intrathecal, and     intra-articular routes. Pharmacokinetic properties of inhaled ketamine have not been studied     officially, but one of the investigators researchers has tested nebulized ketamine on himself     with repeated painful stimulus and monitoring applied. Based on this experiment, analgesic     effect is roughly estimated to begin in 3 minutes.Ketamine has been used successfully to     treat acute pain in intranasal form. The primary purpose of this study is to evaluate whether     nebulised S(+)-ketamine carries potential as a an analgesic bypassing first pass metabolism     and without the need for intravenous access. Secondary aim is to assess the duration of     analgesia obtained by nebulized S-ketamine. Thirdly, the aim is to evaluate whether inhaled     nebulized ketamine decreases the need for rescue analgesia during PACU care. The subjects are     recruited among patients coming in for a surgical intervention (orthopedic, gastrointestinal,     plastic or urologic surgery) and needing further observation in postoperative care unit     (PACU).      It was calculated that sample size of 8 subjects per group would be required to achieve     statistical power of 80% and detect a difference of 3 units in NRS-values with standard     deviation of 2 units and type I error of 5%. To prepare for possible dropouts, total of 20     subjects will be recruited (10 in each group).      Patients will receive either nebulized placebo (i.e. saline) or ketamine (Ketanest-S) when     they require pain alleviation in the PACU. Dosage of ketamine is 1 mg/kg. Patients will be     randomized into two groups so that other group's first inhalation contains ketamine and     second inhalation placebo and in the opposite order.   "
67872|NCT02397343|"     Hyperbaric oxygen may reduce neurophatic pain and promote wound healing. Established anti     inflammatory effects of HBO may contribute to this effect. In a previous publication the     investigators studied the effects of HBO on secondary hyperalgesia using a well established     heat injury model. In a new - blinded study design, the investigators wish to investigate     and- or confirm previous results, i.e. that HBO therapy reduce secondary hyperalgesia and     improving therapy of severe pain conditions.   "
67873|NCT02397330|"     Interscalene brachial plexus block is the gold standard for perioperative pain management in     shoulder surgery. However, this technique would have side effects and potential serious     complications. The aim of this study is to compare between the combination of ultrasound     guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene     brachial plexus block for post operative analgesia after shoulder instability surgery with     latarjet procedure.   "
67874|NCT02397317|"     The SPARK trial is testing the use of Kilovoltage Intrafraction Monitoring in prostate cancer     patients being treated with Stereotactic Prostate Adaptive Radiotherapy. The researchers     expect this trial to result in better targeted prostate cancer patient outcomes with lower     toxicity. The potential application of Kilovoltage Intrafraction Monitoring to other tumour     sites will pave the way for additional trials with Australasian radiation oncology leading     the world.   "
67875|NCT02397304|"     Obesity is a major public health issue and its association with insulin resistance greatly     increases risks for cardiovascular disease and type 2 diabetes. Exercise training is     recommended for obese populations, but longitudinal studies indicate aerobic exercise     training in obese individuals in the absence of weight loss has minimal impact on insulin     resistance. High turnover of fat stored within muscle cells (i.e., intramyocellular     triglyceride) during exercise and elevated muscle fitness (i.e., muscle oxidative capacity)     are key features of the enhanced insulin sensitivity observed in endurance-trained     individuals. It could be that longitudinal studies of exercise training in obese individuals     failed to sufficiently stimulate intramyocellular triglyceride turnover during exercise and     muscle oxidative adaptation as a result of failure to consider the impact of recent nutrition     within their study designs. Performing exercise in the fed vs. fasted state can blunt these     exercise responses in non-obese individuals. The researchers will investigate the hypothesis     that an acute bout of aerobic exercise performed in the overnight-fasted versus fed-state can     stimulate greater intramyocellular triglyceride utilization during exercise and enhanced     expression of genes related to muscle oxidative adaptation in obese individuals. The expected     outcomes will help to determine if exercising in the fasted state could be used to optimise     metabolic adaptation to training in obese individuals. The future impact of this research     could be the recommendation of a simple nutritional strategy considering meal timing to     enhance the effects of aerobic exercise training in obese individuals, with potential     long-term benefits for reducing insulin resistance and cardio-metabolic disease risk.   "
67876|NCT02397291|"     The purpose of this study is to determine whether the transplacental gradients for 6 polyols     and mannose are altered in intrauterine growth restricted (IUGR) pregnancies compared to     normal pregnancies and b) to determine the relative contributions of transplacental transport     vs production by the conceptus of both inositol (the major polyol) and mannose in IUGR and     normal pregnancies using stable isotopic methodology.   "
68105|NCT02394301|"     ENDURE is a prospective, observational study aimed to document clinical response and side     effects associated with compounded psoriasis medications when prescribed as routine care. As     a secondary initiative, this study will assess methotrexate systemic absorption and toxicity     in patients prescribed a methotrexate-containing compounded formulation.   "
67886|NCT02397161|"     Objective: To compare the effectiveness of EEG biofeedback mental attention-neuromuscular     training (AT-NMT), neuromuscular training (NMT) alone, EEG biofeedback mental attention     training (AT) alone, and no intervention for improving reactive balance performance among     children with developmental coordination disorder (DCD).      Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with     DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes:     Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor     control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings     during MCT will measure the mental attention level, and surface electromyography recordings     during MCT will indicate the lower limb muscle onset latency.   "
67887|NCT02397148|"     This study compares the morphological concordance between CT (computed tomography) and cone     beam in sinus on 26 validated items. CT and cone beam is performed on each patient.     Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of     the ionizing radiations is lower with the cone beam.   "
67878|NCT02397265|"     The diabetes technology group at Imperial College have developed a bio-inspired artificial     pancreas (BiAP) system which uses a control algorithm based on a mathematical model of     beta-cell physiology. The algorithm is implemented on a miniature silicon microchip within a     portable handheld device, which interfaces the components of the artificial pancreas.      Development of closed-loop insulin delivery devices to intensify control without     hypoglycaemia has been extensively reviewed and have shown encouraging results . However,     they have not yet proven to be robust when challenged with uncertainty and the external     challenges (such as mixed meal contents, physical exercise, physiological stress and     intercurrent illness) that people with Type 1 Diabetes Mellitus (T1DM) may be exposed to     outside the clinical environment.      The principal research objective is to assess the safety and efficacy of a closed-loop system     for T1DM compared to standard insulin pump therapy (open-loop). The primary outcome from the     studies will be % time spent with a glucose concentration in the target range     (3.9-10.0mmol/l). This outcome incorporates safety as it ensures subjects do not have low or     high glucose excursions and is the principal measure of efficacy for closed-loop insulin     delivery systems in the scientific literature. Other measured outcomes will be % time spent     in euglycaemia (3.9-7.8mmol/l), % time spent in hypoglycaemia (<3.9mmol/l), % time spent in     hyperglycaemia (>10mmol/l), mean venous blood and sensor glucose, glycaemic variability as     measured by standard metrics (Standard Deviation, Continuous Overlapping Net Glycaemic     Action, Lability Index, J-Index, Glycaemic Risk Assessment Diabetes Equation, Mean Of Daily     Differences, Mean Amplitude of Glucose Excursion, Average Daily Risk Range, M-VALUE, Mean     Average Glucose), glycaemic risk as measured by Low Blood Glucose Index (LBGI) and High Blood     Glucose Index (HBGI), closed-loop error grid analysis, glucose area under the curve. All     measures have been previously published and validated.      This clinical trial protocol assesses the artificial pancreas system in three separate     sub-studies:        1. In a bi-hormonal (insulin and glucagon) configuration        2. During and after exercise with bi-hormonal closed loop, and standard insulin opened loop        3. During and after meals of mixed composition with bi-hormonal closed loop, and standard          insulin opened loop   "
67879|NCT02397252|"     The proposed study seeks to compare the diagnostic performance of Human Papillomavirus (HPV)     testing in self-collected samples via the Eve Medical self-collection system© (Eve) with     standard physician-collected samples for the detection of cervical intraepithelial neoplasia     grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The     performance of the Eve sample will also be compared with that of a second self-sample via a     cobas® PCR Female swab.      Approximately 1000 adult women with an abnormal Pap test at the level of an atypical squamous     cells of undetermined significance or worse squamous or glandular abnormality (i.e., ASCUS+)     or an abnormal co-test (ASCUS+ and HPV-positive) result will be recruited over a period of 12     months via colposcopy clinics located at the Jewish General Hospital, St-Mary's Hospital, and     the McGill University Health Centers (Royal Victoria Hospital).      Participating women will undergo three cervical or cervicovaginal sampling techniques: 1)     self-sampling using the Eve Medical self-collection system©; 2) self-sampling using a cobas®     PCR Female swab; and 3) physician-collected sampling. The participants will also fill in a     questionnaire on their experience with the convenience and acceptability of the Eve system,     relative to the other two sampling approaches. The decision as to which self-sample is to be     collected first will be dependent on randomization      HPV testing will be done using the cobas® 4800 HPV Test. The liquid medium of within the     cobas® PCR CELL Collection Media with the provider collected sample and the cobas® PCR media     with the two self-collected samples will be used to suspend the cellular material prior to     HPV testing. We have made collaborative arrangements with Dr. Marcel Behr, Chief of the     Department of Clinical Microbiology at the McGill University Health Centre for the HPV     genotyping work.      Histology-confirmed CIN1+ will form the study outcome or case definition. Sensitivity,     specificity, and predictive values (along with their respective 95% confidence intervals)     will be calculated for each sample type to evaluate the clinical performance of the various     sampling techniques. We will use CIN1+ as definition of disease but analyses will also be     performed for more stringent definitions, e.g. CIN2+ or CIN3/cancer.   "
67880|NCT02397239|"     Protocol title:      Comparison of cost-effectiveness of continuation maintenance therapy with six cycles of     pemetrexed versus pemetrexed until disease progression for metastatic non-squamous     non-small-cell lung cancer (NSCLC)      Study design:      An open-labelled, randomized, phase 2 trial      Indication:      Patients with stage IV non-squamous NSCLC, an Eastern Cooperative Oncology Group (ECOG)     performance status of 0-1, and have received first-line or second-line chemotherapy with     pemetrexed plus platinum for 4 cycles      Treatment:      Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles versus until disease     progression      Objectives:      Primary endpoint:      1. Cost-effectiveness in the intention-to-treat population      Secondary endpoints:        1. Progression-free survival        2. Overall survival        3. Quality-of-life (QoL)        4. Quality-adjusted progression-free survival (QA-PFS)        5. Quality-adjusted life expectancy (QALE)        6. Tumor response rate        7. Adverse events      Planned sample size:      61 patients in each arm; total 122 patients      Total number of sites:      1 site      Duration of patient enrollment:      3 years   "
67881|NCT02397226|"     200 patients with insufficient great saphenous veins will be randomized to either     radiofrequency ablation or high ligation/stripping (open surgery). They will be examined     according to standardized examination protocol Venous Clinical Severity Score (VCSS), with     duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years).     They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen     Varicose Vein Questionnaire (AVVQ).   "
67882|NCT02397213|"     The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and     degree of acute kidney injury after cardiac surgery.   "
67883|NCT02397200|"     Study design:      Double blind, randomized, placebo controlled study. Participants will be randomly assigned     either to the intervention group or the placebo control group. Randomization for the two     study groups will be made in a ratio of 1:1.      The primary objective of the study is to assess the effect of 6-12 months treatment with     nutritional supplementation standardized formula, in short and lean female adolescents on     weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study     are to assess the effect of 6-12 months treatment with nutritional supplementation     standardized formula, in short and lean female adolescents on BMI SDS, growth velocity, time     to puberty, quality of life and self-esteem The study will continue for 6 months of     intervention versus active placebo, with additional optional 6 months (an extension period),     in which participants at both groups, the intervention and the placebo, will be offered to     continue their participation in the study with the study supplement. All analyses of the     effect's on primary and secondary outcome measurements will take into account the consumption     rate of the study formula/placebo   "
67884|NCT02397187|"     The assessment of the efficacy of a structured, dimension-based, STI (Short Term     Intervention) in de-compensated Personality-disorder, hospitalized, patients   "
67885|NCT02397174|"     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women     that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance.     Available guidelines recommend lifestyle intervention although they do not suggest the best     dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the     effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in     PCOS women.   "
68106|NCT02394288|"     This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in     patients without cardiac risk factors undergoing extremity orthopedic surgery. This study     will provide important evidence on how to interpret postoperative cardiac troponin     elevations.   "
68345|NCT02391168|"     A multi-center, prospective cohort study on the natural history of fatty liver disease in     China   "
67888|NCT02397135|"     IVF (in vitro fertilization) cycles fails more often than they succeed. Surprisingly very     little effort is invested in defining the reasons for failure and possibly finding ways to     improve the success on the next cycle. The investigators believe that the main reasons for     failure are related to oocyte quality and indirectly to the follicle response for a     particular patient. The investigators have developed a panel of biomarkers to assess the     faulty follicular conditions leading to lower oocyte quality. Using these markers would     indicate if a given cycle was characterized by over growth, over-luteinization, early or late     trigger. Indeed our transcriptomics analysis has identified biomarkers of follicles still in     their growth phase at trigger or follicles that have already begun luteinisation compare to     follicle that are at the optimal level of differentiation. Measuring these biomarkers would     allow making a better diagnostic for a given patient and potentially explaining reasons for     failure. The system would also become adjustable to variable COS (control ovarian     stimulation) and individual clinical practices. It is important to realize that this is     applicable to almost all cycle failure and can be done on a pool of follicular cells when     none of the oocytes obtained has led to a pregnancy. This does not resolve uterine problems     but often these are caused by hormonal conditions established by the ovary or the ovarian     treatment. This technology can be applied in all IVF clinics as no special equipment is     required. It would be particularly valuable in clinics where a number of cycles is limited     due to funding, or in clinic where a package of 3 cycles is proposed to the patient. The     patient interest to have a custom treatment increases at each failing cycle as well as the     doctors' interest to succeed. This technology is not clinically validated yet and would     require a period of testing where participating clinics will collect the samples for a     retrospective analysis (presence of biomarkers of follicular problems vs outcome) then in a     prospective analysis where the diagnostic is used in a sub-set of patient to modulate the     second/third cycle compared the outcome to patient with no diagnostic. The increase in     pregnancy rate or cumulative pregnancy rate should reach a minimum of 10 and 25 %     respectively to indicate a significant value.   "
67889|NCT02397122|"     The aim of the trial is to evaluate the effectiveness of coronally advanced flap     (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II     recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either     with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index     (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level     (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ),     tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2)     post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized     tissue change (KTC) were also calculated.   "
67890|NCT02397109|"     The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a     hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor     muscles and the orbital fat.      If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional     contribution to the clinic, guiding the therapeutic management by detecting inflammatory     lesions not found on clinical examination in 1/3 of cases.      The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal     analysis oculomotor abnormalities as well as the orbital fat.      Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In     addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous     fat removal.   "
67891|NCT02397096|"     The study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine]     plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants     virologically suppressed on a protocol-specified antiretroviral regimen. The primary     hypothesis is that a switch to MK-1439A will be non-inferior to continuation of the regimen     at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1     ribonucleic acid (RNA) <50 copies/mL. The Base Study will last up to 50 weeks. An optional     Extension Study will evaluate long-term efficacy and safety of the switch to MK-1439A for an     additional 2 years.   "
67892|NCT02397083|"     You are being asked to take part in this study because you have endometrial hyperplasia (a     pre-cancerous growth of the lining of the uterus) and/or early-stage endometrial cancer.      The goal of this clinical research study is to learn if the Mirena intrauterine device     (levonorgestrel IUD), alone or in combination with everolimus, is effective for the treatment     of endometrial hyperplasia and/or early-stage endometrial cancer.   "
67893|NCT02397070|"     This study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular     disorder patients (TMD). An eligible group of patients will be treated with that therapy     (experimental group) and another group will be treated with counseling and occlusal splint     (control group), considered the standard therapy for TMD.   "
67894|NCT02397057|"     This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study.     Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days     0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The     subject's participation in the study will be for approximately 1 year from Day 0.   "
67895|NCT02397044|"     The purpose of this study is to compare the success rates of two surgical protocols. One     protocol will have the implants placed at the time of tooth extraction and placed into     function. The other protocol will have the implants placed into healed extraction sites and     placed into function.   "
67896|NCT02397031|"     The purpose of the study was to determine whether mindfulness training could be more     effective than another active intervention in reducing borderline personality disorder (BPD)     symptoms. The main hypothesis was that patients allocated to the mindfulness group would show     a greater improvement on global BPD symptomatology. As a second objective, we explored some     of the possible underlying mechanisms of both active treatments. For that purpose, changes in     decentering, mindfulness facets and cognitive processing of social interactions were also     evaluated.   "
67897|NCT02397018|"     This is a phase one study investigating the safety of a single, intravenous infusion of     banked allogeneic umbilical cord blood in subjects following an acute ischemic stroke. The     cord blood infusion must be given within 3-10 days of the stroke. Follow up phone calls will     occur at 1, 6, and 12 months post-infusion, and will include telephone surveys on post-stroke     rehabilitation and functioning. A follow up clinic visit at 90 days will include a     neurological exam, MRI, and blood tests.   "
67898|NCT02397005|"     The first-in-man study are designed as below to assess safety, tolerability, and preliminary     pharmacokinetics of ZL-2102.        -  Double-blind randomized, placebo-controlled ascending single oral doses (Part 1,          ZL-2102-SAD);        -  Open-label, randomized, 2-sequence, 2-period, 2-treatment crossover (Part 2,          ZL-2102-FED);        -  Double-blind randomized, placebo-controlled, ascending repeated oral doses for 14 days          (Part 3, ZL-2102-MAD).      A total of 104 subjects will be enrolled.   "
67911|NCT02396901|"     This is an randomised controlled trial to investigate an strategy based in a protocol in     prevention of acute kidney injury after cardiac surgery.   "
67899|NCT02396992|"     The purpose of this study is to apply a minimal-massive intervention (minimal recommendations     to maximal number of patients) to elderly (>70 years) hospitalized patients with     oropharyngeal dysphagia (OD). The intervention will consist of early screening and assessment     of OD, malnutrition and oral hygiene. Patients will be given recommendations for adaptation     of volume and viscosity of fluids, nutritional support and good oral hygiene practices and     followed at 3, 6, 9 and 12 months after discharge. In every point of the follow-up period,     patients will be re-evaluated to adjust recommendations and to verify their compliance with     the treatment.      The objectives of the intervention are to have an impact on complications related to OD     (avoid impaired safety alterations and improve nutritional and oral health status and reduce)     and to reduce readmissions, readmissions for pneumonia and morbimortality.   "
67900|NCT02396979|"     The purpose of this study is to evaluate the relative impact a medical drug (methadone) or     behavioral counseling program (Holistic Health Recovery Program) or both (methadone and     Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug     use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days     prior to leaving prison.   "
67901|NCT02396966|"     The purpose of the protocol is to evaluate and describe QoL, in the population of Polish     acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term     observation).   "
67902|NCT02396953|"     The objectives of the protocol is to determine the maximum tolerated dose and to investigate     the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.   "
67903|NCT02396940|"     The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD     resolution in inguinal hernia repair in terms of error rating, performance time and     subjective assessment.   "
67904|NCT02396927|"     The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD     resolution in cholecystectomy in terms of error rating, performance time and subjective     assessment.   "
67905|NCT02395887|"     High percentage of chronic back pain is due to spinal stenosis. The clinical picture is of     'neurogenic claudication' which effects postural balance and stability. If conservative     treatment fail to improve symptoms, an invasive treatment which includes spinal decompression     can be done.      The research is an observational prospective one, pre and post operational intervention. The     aim is to examine whether an operational intervention improves quality of life, pain,     postural balance an stability among patients.      It's important to clarify, that although there is operational intervention, the research is     observational. The decision weather to operate or not, is not a part of the research. The     investigators assume that since there is a population that independently going through an     operation, the investigators can observe this population and evaluate different aspects of     the operation outcomes.   "
67906|NCT02395874|"     To study the effect of combined tDCS plus speech therapy compared to sham-tDCS plus speech     therapy in subacute stroke patients suffering from moderate or severe aphasia. The patients     will be randomized by a computer-generated lot. Assessment will be performed at study onset,     after six weeks at the end of the specific intervention and 4 months after stroke onset for     follow-up.   "
67907|NCT02395861|"     Severe diseases in intensive care unit (ICU) patients are associated with a high mortality     rate which nevertheless remains difficult to predict. Recently, the abolition of some     brainstem reflexes at clinical examination of ICU patients within the first 24 hours after     has been shown of prognostic value in ICU patients requiring sedation. Early abolition of the     cough reflex was associated with an increase in mortality and that of the oculocephalic     reflex was predictive of coma or delirium after sedation has been stopped. A dysfunction of     the brainstem may account for these results and be present in other patient subpopulations,     particularly those who do not receive iv sedation or the brain injured patients, who were     eluded from the previous study. This dysfunction could take place in the muti-organ failure     characteristic of the severe ICU patient. On the other hand, a preliminary study performed on     somatosensory evoked potentials has shown that a latency of the P14 wave greater than 16 ms     between day 1 and day 3 after admission was associated with death at 28 days. The primary     goal of this project is to confirm this hypothesis. By studying the clinical and     electrophysiological responses of the brainstem in ICU patients, with or without brain     injury, with alteration of consciousness in relation or not with sedation. The other     objectives are to determine the correlations between neurophysiological clinical     neurological, or neuroradiological data with delirium occurrence.      The main objective of this study is to determine, in ICU patients with or without brain     injury and with alteration of consciousness in relation or not with sedation, if abolition of     the cough reflex at Day 1 after admission is predictive of mortality at 28 days, independent     from cause for admission and severity.   "
67908|NCT02395848|"     This is a medical research study designed to look at the safety and efficacy of 30-day course     of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI is an     infection that results when the normal flora (resident bacteria) of the colon is     substantially altered by antibiotic treatment. The decrease in this normal flora allows for     the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by     Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode     of recurrent CDI have been studied using a 10-day course of fidaxomicin.   "
67909|NCT02395835|"     The main objective of this study was to assess whether clinical, anthropometric, and     biochemical variables of the mother were associated with changes in the methylation of the     PPARg promoter region (-351 to -260). Methodology: This was a matched cohort study with two     groups: a) normal weight (NW) pregnant women (n = 21) and their offspring, and b) overweight     (OW) pregnant women (n = 20) and their offspring. DNA was extracted from leukocytes     (4000-10,000 cells) in the MagnaPure (Roche) using the MagNAPure LC DNA Isolation Kit 1     (Roche, Germany). The treatment of DNA (2 µg) was performed with sodium bisulfite (EZ DNA     Methylation-Direct Kit, ZymoResearch). Real-time polymerase chain reaction (qPCR) was     performed in a LightCycler 2.0 (Roche) using the SYBR® Advantage® qPCR Premix Kit (Clontech).   "
67910|NCT02395822|"     A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in     adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed     or refractory acute myelogenous leukemia (AML). The primary objective is to study the     potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining     safety.   "
67913|NCT02396875|"     Cardiac resynchronisation therapy (CRT) prolongs the life and improves the symptoms in     patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve     with the treatment which is both expensive and not without complication. Despite much     research, we cannot accurately predict who will not respond. Furthermore, most heart failure     patients gets symptoms on exercise and most studies have examined patients at rest. We     propose to investigate the effect of exercise on different parts of the left ventricle by     sampling various biomarkers of metabolism, myocardial injury and gene expression. We will     then repeat the protocol following device insertion to look for changes. This novel work will     require a small cohort of patients with heart failure and no electrical dyssynchrony and     normal patients to act as controls. We will also measure novel biomarkers at different venous     sites relating to different parts of the myocardium to determine whether they can be used to     prognosticate or even predict response to CRT.   "
67914|NCT02396862|"     The purpose of the study is to improve the understanding of key patient reported outcomes     such as quality of life as well as clinical outcomes in hemophilia A, in a global real world     setting.   "
67915|NCT02396849|"     The purpose of this study is to see if the use of a machine called CPAP will help children     with asthma breathe better. CPAP is a machine that produces airflow to help people with     breathing problems. To use it, you will wear a mask connected by a hose to the CPAP machine.     We believe that use of CPAP may be a treatment for children with asthma.   "
67916|NCT02396836|"     The aim is to compare the effectiveness of the 6 step hand rub technique versus 3 step hand     rub technique in hand coverage and in reducing bacterial contamination on the hands of     healthcare workers in practice.      Research questions        1. What is the effectiveness of the 6 step technique in hand coverage compared to the 3          step technique?             1. What are the most frequently missed sites in hand surface coverage using 6 steps               compared to 3 steps?             2. What is the reduction in bacterial contamination of the hand with the 6 step               compared to the 3 step technique?        2. Does site missed or coverage relate to bacterial load?        3. What is the time taken for 6 step technique versus 3 step technique?   "
67917|NCT02396823|"     The proposed study is designed to answer a novel research question: Can resistive respiratory     muscle training designed to improve respiratory motor control also improve blood pressure     regulation impaired by spinal cord injury? Resistive breathing exercise, or respiratory     muscle training, has been applied to rehabilitate breathing after spinal cord injury, but has     not been evaluated as a method for increasing resting blood pressure and / or improving its     regulation under stress as is planned in the proposed project. For the first time,     respiratory muscle training intervention will be used as a tool to investigate the     physiological relationships between pulmonary and cardiovascular function in individuals with     Spinal Cord Injury (SCI). Thus, it will foster a new direction from which to address     neglected issues surrounding the cardiovascular complications of spinal cord injury.   "
67918|NCT02396810|"     The investigators are studying the utility of intra-operative magnetic resonance imaging     (iMRI) during transsphenoidal pituitary surgery by randomizing patients to either an     intra-operative MRI after resection, or no intra-operative MRI. The investigators will then     count the number of gross total resection in each group of patients and also the     complications related to surgery.   "
67919|NCT02396797|"     Mental disorders is one of the most frequent causes of long-term sick leave and disability     pensions in Norway, and there is a need for a comprehensive, coordinated response from health     and social sectors at the country level to address the burden of mental disorders. The aim of     this project is to investigate if a workplace intervention with the aim to increase coping of     common mental health complaints and social support can reduce sick leave and improve health.   "
67934|NCT02396602|"     Using our experience in digital media, behavior theory, client-centered interventions, and     family planning, we have prototyped a digital application (app)—miPlan—to be used in the     clinic waiting room prior to a contraceptive visit. The goal of this research is to refine     the app and conduct a randomized controlled trial of the miPlan intervention vs. standard     care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC     uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge,     self-efficacy and decisional balance for highly effective contraception post-app use,     contraceptive satisfaction, and intention to continue method use. The research will consist     of baseline activities as well as a three-month follow-up call.   "
68117|NCT02394145|"     Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet     reactivity to clopidogrel than did those with normal renal function. We recently reported     platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with     onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted     genetic influence in high platelet reactivity in patients with ESRD on HD.   "
67920|NCT02396784|"     Early STOPP project promotes good health in children from early age by supporting good habits     for the whole family. Our aim is to see if we can prevent overweight and obesity in children     in families where parents are overweight or obese. Normal weight parents will also be needed     in this study.      Background: Several daily habits lead to less favorable health factors. For example, using     the car instead of cycling or walking - leads to less activity in everyday life. Individuals     also eat more unhealthy foods in larger portions. In combination with genetics, social in     heritage and surrounding factors this contributes to increase overweight and obesity among     children not only in adults but also in children.      Good treatment for childhood obesity are lacking, making prevention very important. The     earlier good habits are introduced to a child the better it is.      In Early STOPP project we study food, physical activity and sleep habits in the families with     a child of one year of age. The height, weight, waist circumference and blood pressure will     be recorded in both child and parents. The parents will answer questionnaires about food,     physical activity and sleeping habits for both the child and themselves. During the study,     the child's physical activity will be measured. Based on our observations we aim to develop     the preventive strategies for the families with very young children.   "
67921|NCT02396771|"     The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine     compression after vaginal delivery with respect to blood loss and maternal pain. It is a     randomized controlled trial that will be conducted at the American University of Beirut     Medical Center - Delivery Suite.   "
67923|NCT02396745|"     This study will test the safety and effectiveness of esophageal transoral endoscopic     circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat     Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential     resection using ECM placement has been introduced as a less invasive, externally     incision-less approach to treat patients with esophageal high grade dysplasia; a     pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa     (esophagus lining) will be removed using an endoscope that will be inserted through the     mouth. The ECM will be placed over the area that is being removed with a temporary,     expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the     ECM in place as the body begins the healing process. This stent will be removed 14 days (±4     days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow     x-ray tests, and questionnaires will take place for 12 months following the procedure. The     result of this study may help doctors determine if this procedure would be a more effective     treatment option for HGD in the future.   "
67924|NCT02396732|"     The purpose of this study is to determine if the addition of antiplatelet therapy (i.e.     aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of     venous thromboembolism (VTE) in high-risk critically injured patients. The investigators     further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and     enoxaparin for decreasing the incidence of VTE after trauma.   "
67925|NCT02396719|"     The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond     laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.   "
67926|NCT02396706|"     Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety     of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough   "
67927|NCT02396693|"     Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome     in an attempt to assist failure extubation. The investigators investigated failure extubation     in infants gestational age less than or equal to 34 weeks and weights less than or equal to     1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were     included in this study in three groups , group 1: Nasal Intermittent Positive Pressure     Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP     bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator     (NCPAP ventilator) (n=32)   "
67928|NCT02396680|"     The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the     initial dose.   "
67929|NCT02396667|"     5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine     estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by     ultrasound will be compared to actual birth weight.   "
67930|NCT02396654|"     5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation     and fetal weight will be estimated using the hadlock formula using biometry measured by both     ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.   "
67931|NCT02396641|"     The primary objective of this study is to formalize the delivery of BSC in advanced cancer     trials. The first aim (to develop expert-derived consensus statements regarding components of     supportive care in cancer clinical trials) and the second aim (to compare the extent to which     documentation of current supportive care delivery in trials compares to the consensus     statements) have been completed. The final aim of this study is to test the feasibility of     thorough documentation of BSC delivery. That work is proposed as the primary aim of this     study.   "
67932|NCT02396628|"     The preliminary data demonstrate potent activity of Ruxolitinib in steroid-refractory aGvHD.     In this phase 2 trial the efficacy of Ruxolitinib and best available treatment (BAT) versus     BAT in steroid-refractory acute GvHD in approximately 12 transplantation centers in Germany     will be compared. The response by monitoring the clinical GvHD grade, requirement of     alternative GvHD active agents and serum levels of pro-inflammatory cytokines will be     determined.   "
67933|NCT02396615|"     The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red     ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the     short-term.   "
67984|NCT02395952|"     The purpose of this study is to compare the relative efficacy of four different treatment     modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane,     Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following     retina surgery.   "
67985|NCT02395939|"     Obtaining a tissue sample to diagnose a PPL suspected of cancerous origin is of utmost     importance. The current gold standard; Transthoracic CT guided needle biopsy approach with a     success rate of >90% comes at the expense of an increased side effect profile.      Given that most lung cancers originate in the bronchus, hence named bronchogenic carcinoma,     it would be rational to think that endobronchial route should provide the best route of     sampling with the least amount of side effects. Radial EBUS has become popular during the     last decade as an endobronchial modality in diagnosing PPL with minimal side effects.     However, the yield is still not satisfactory in comparison to CT guided biopsy with only 73%     success rate in a meta-analysis. There is also with wide variation in different centres.      Use of a new biopsy method called cryo-biopsy using the R-EBUS guide sheath may bridge the     gap and increase the diagnostic yield of PPL.      Cryo biopsy had been proven to give larger sample sizes and reduced crush artefact compared     to the conventional radial EBUS biopsies.      However, there have been no head to head trials comparing Cryo-probe biopsy vs. the gold     standard: CT guided biopsy.      Cryo-biopsy has very favourable side effect profile without any pneumothorax occurrence. If     the yield were to be non-inferior to CT guided biopsy this would certainly be the preferred     choice of biopsy for PPL in the future.      Methodology All patients with a PPL requiring a diagnostic biopsy will be eligible for     recruitment to the trial. The recruited patients will be randomly allocated to either CT     guided core biopsy or radial EBUS guided cryobiopsy.      Study design Multi centre intervetional,randomised control trial.      Study population:      Patients diagnosed with a PPL that requires a biopsy.      If the patient is randomised to the cryo biopsy arm:      The procedure will be done under the usual guidelines and practice of the centre as for a     flexible bronchoscopy procedure.      Once flexible bronchoscopy is introduced the pre-determined desired segment, the R-EBUS is     inserted covered by the GS.      Once the R EBUS locates the lesion, the GS is left in situ and the USS probe is retracted.      The cryoprobe is then inserted through the GS to the desired location. Flexible Cryoprobe     (outer diameter 1.9mm) will be applied for 4 seconds for each biopsy. The cryogen gas used     will be Co2.      The probe will be retracted together with the GS and the bronchoscope en masse after each     biopsy. A minimum of 1 and maximum of 3 samples will be taken.      A CXR is taken within 1 hour post procedure to access for pneumothorax. Adverse events during     the procedure will be recorded. If a chest tube placement, other investigations due to side     effects or overnight hospital stay were to be required; all costs will be calculated     retrospectively. Minor bleeding will not be considered an additional cost as this occurs with     routine bronchoscopy.      If the patient is randomised to the CT biopsy arm:      A CT guided core biopsy will be performed as per usual practice of that centre. 2-6 passes     will be performed for each PPL.      A CXR 1hour post procedure will be performed to assess for pneumothorax or procedure related     bleeding.      If a chest tube placement, other investigations due to side effects or overnight hospital     stay were to be required all costs will be calculated retrospectively.      At the pathology:      All samples will be assessed for the size of the sample and the suitability for molecular     testing. An independent pathologist will assess samples.      Economic analysis:      For both procedures: Both direct and indirect costs will be calculated. The main aim of cost     analysis is to calculate the cost of side effect management in each arm to determine the most     cost-effective method of sampling a PPL.   "
67935|NCT02396589|"     Stroke is one of the most serious, disabling health conditions in the United States. Patients     who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes     for many persons with stroke may be low because of incomplete treatment. The investigators     will conduct a randomized controlled trial and a process evaluation to examine the     feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition     program, Community Participation Transition after Stroke (COMPASS), designed to bridge     inpatient rehabilitation and the home to support the performance of everyday activities.   "
67936|NCT02396576|"     In partnership with a multi-site, Los Angeles-area community clinic consortium, North East     Valley Health Corporation (NEVHC), the investigators will use telehealth to integrate     pediatric developmental, behavioral and mental health (DB/MH) services into primary care for     low-income, publicly insured children. During Project Year 1, the investigators used     qualitative methods to conduct and analyze interviews with parents, clinicians, and staff at     NEVHC to assess their perspectives on the delivery of child DB/MH services and on a potential     telehealth-based patient visit, coordination, and clinician education system for the     provision of DB/MH specialty care in primary care settings to children ages 5-12. This data     was used in a stakeholder-engaged process to customize a telehealth-based delivery system for     pediatric DB/MH services that can be integrated into primary care settings.      During Project Years 2-3, the investigators will conduct a cluster randomized controlled     trial (RCT) to compare the customized telehealth-based patient visit, coordination, and     clinician education system to the usual in-person, community- based referral system at NEVHC.     This study will examine whether a telehealth developmental, behavioral and mental health     delivery model can be an effective, efficient, and family-centered way to provide integrated     DB/MH services to children in low-income communities.   "
67938|NCT02396550|"     Lateral epicondylalgia affects people of both gender between 1 and 3% of the world     population, with up to 15% in the working population reaching an average of 12 weeks off work     for this reason. One of the conservative treatments that have shown effective is the     mobilization with movement, whose mechanisms of action are not known. According Bialosky et     al., possible effects of manual therapy are based on the neurophysiological mechanisms at     peripheral, spinal and supraspinal level. Among the mechanisms to supraspinal level is the     placebo effect, which is influenced by psychological factors such as conditioning and     expectations.      Changing expectations to determine the influence on the treatment has been studied in healthy     subjects, showing improvement with positive expectations and worsening to negative and     neutral expectations.      However the result of modifying the previous expectations for treatment in patients with pain     has not been studied.      The aim of our study is to test the influence that positive expectations have on the     effectiveness of treatment with mobilization with movement in patients with lateral     epicondylalgia.   "
67939|NCT02396537|"     The purpose of this study was to establish whether premedication with topical lidocaine would     reduce the pain associated with IN midazolam administration in children. The study was     designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban,     academic pediatric emergency department.   "
67940|NCT02396524|"     The Hockey Fans in Training (Hockey FIT) program aims to improve overweight men's physical     fitness, eating habits and health-related lifestyle choices through a lifestyle modification     program in collaboration with two Ontario Hockey League teams. In this pilot pragmatic     randomized controlled trial, the investigators plan to explore the potential for Hockey FIT     to reduce a clinically important amount of weight, increase physical activity levels, and     lead to improvements in other health-related outcomes.   "
67941|NCT02396511|"     The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is     effective in the treatment of one patient with metastatic and refractory choriocarcinoma.   "
67942|NCT02396498|"     The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic     intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy   "
67943|NCT02396485|"     After institutional review approval, pregnant women that are scheduled for elective cesarean     delivery will be approached for participation in the study. The study informed consent will     be obtained. The study's time frame inclusive will be from 2013 till 2016.      Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus     remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced     as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the     investigators' institution.      Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length     of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be     performed using a computer generated random list of numbers assigning patients to the 2     groups of the study. This list of random number assignments will be kept secure in an opaque     envelope until the end of the study. Patients in the Early group will be started on regular     diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO     12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as tolerated,     i.e. if clears were tolerated or flatus or bowel movement occurred, patients will be started     on solid foods. If diet not tolerated, a full liquid diet will be given instead. Consequently     if patient tolerated full liquid diet, a regular diet will be then initiated. Patients will     be discharged home only if they tolerate solid food with absence of emesis, have flatus or     bowel movement. Time Zero is defined as time of skin incision.   "
67944|NCT02396472|"     People facing serious health threats increasingly use Internet health support communities to     obtain informational support, emotional support and other resources. This study introduces     software algorithms similar to those used by social media sites to put people in touch with     helpful information and social interactions. Participants from the American Cancer Society's     Cancer Support Network will have access to this online support group using the default     interface that orders content by broad content category and date or with a new interface that     highlights communication content and people that match users' interests and needs.   "
67945|NCT02396459|"     Triac Trial II will assess the effects of Triac therapy on several neurocognitive end-points     in patients with the Allan-Herndon-Dudley Syndrome (AHDS).      Patients with the AHDS suffer from severe psychomotor retardation. A mutation in the TH     transporter protein Monocarboxylate transporter 8 (MCT8) results in reduced thyroid hormone     (TH) levels in de brain, leading to an impaired neuronal differentiation. The severe     neurological phenotype is accompanied by increased T3 levels in the blood, resulting in a     variety of thyrotoxic symptoms such as tachycardia, increased metabolism, weight loss and a     low muscle mass.      Currently, Triac Trial I (NCT02060474) investigates if Triac treatment in AHDS patients     reduces the toxic effects of the high T3 levels. In addition, the safety of Triac     administration in AHDS patients is assessed.      In Triac Trial II we will focus on the effects of Triac on the neurocognitive development.   "
67946|NCT02396446|"     This study is being conducted to determine whether providers who have access to their     patients' acoustic intestinal rate score as calculated by an abdominal acoustic sensor that     continuously monitors bowel sounds (AbStats) will be more likely to advance their patients'     diets to a solid diet sooner than those who do not have access to this rate. AbStats     calculates intestinal rates by using two small sensors placed on a patient's abdomen to     measure and analyze their abdominal sounds.      Patients will be asked to wear a sensor every morning for 20 minutes while they are fasting     daily during their inpatient visit. The sensor will measure the sounds within their abdomen.     This data will be interpreted by the AbStats device, which will provide an intestinal rate     measurement based on the sounds recorded by the sensors.      This intestinal rate will be provided to the patient's treating physician together with other     vital signs. The doctor, at his/her discretion, may choose to use this information to make     decisions about the patient's feeding status.   "
67947|NCT02396433|"     Non-randomized, open-label, multi-center, phase I/II, dose-escalation study of the     combination of carboplatin, eribulin, and E7449.   "
67948|NCT02396420|"     The purpose of the study is to evaluate improvement in symptoms related to benign prostatic     hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere     Microspheres.   "
67950|NCT02396394|"     WiseMama is designed to improve our understanding of interventions that are feasible and     effective in helping HIV-positive pregnant and postpartum women to maintain high adherence to     antiretroviral medications. The study will involve: a) assessing the feasibility and     acceptability of the use of an innovative pill container equipped with real-time electronic     data monitoring capacity by HIV positive pregnant and postpartum women in Uganda; b)     generating preliminary effectiveness data of a 2-step feedback intervention on retention in     care, antiretroviral therapy adherence, and clinical outcomes (CD4 and HIV viral load (VL));     c) exploring patient and provider perspectives on barriers and facilitators to retention in     care and adherence to antiretroviral therapy in our study population.   "
67951|NCT02396381|"     The aim of the study is to demonstrate clinical, biological and functional health changes in     smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2     (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a     26-week period.   "
67952|NCT02396368|"     This is a Phase I/Ib study of Radium-223 in combination with Tasquinimod for patients with     bone metastases from castration-resistant prostate cancer (CRPC).      The investigators propose to determine the spectrum of tolerability of the combination of     tasquinimod and radium-223 and determine a dose for a subsequent randomized phase II study     (first cohort) and the proportion of men with bone-specific alkaline phosphatase response     (second cohort).   "
67953|NCT02396355|"     The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune     status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD     FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing     the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin     (Hb) concentration in human whole blood.      This is a prospective study to determine the relative bias between the investigational BD     FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their     determination of absolute CD4, % CD4, and Hb concentrations.   "
67954|NCT02396342|"     This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with     severe or moderately severe hemophilia B and severe bleeding type.   "
67955|NCT02396329|"     There is no difference between using chlorhexidine-based antisepsis protocol versus     povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean     section.   "
67956|NCT02396316|"     To assess the efficacy and safety of the administration of aflibercept by intravitreal     injection in comparison to sham to control intraocular pressure in patients with neovascular     glaucoma.   "
67957|NCT02396303|"     Post-partum haemorrhage is one of the life threatening emergencies. It accounts for nearly     one-quarter of all maternal death worldwide. Atonic uterus contributes about 80% among the     causes. Uterotonic drugs are administered following the delivery of baby both in vaginal and     caesarean delivery for prevention of PPH. However postpartum haemorrhage cannot always be     prevented. But, the incidence and especially its magnitude can be reduced by assessing the     risk factors and following the guidelines. The intelligent anticipation, skilled supervision,     prompt detection and effective institution of therapy can prevent a normal case from     undergoing disastrous consequences. This study will be carried out at Bangabandhu Sheikh     Mujib Medical University (BSMMU) within six months after approval. This is a Randomized     Control Trial which will compare efficacy of Carbetocin and Oxytocin for the control of PPH.     Structured Questionnaire, Data Sheet, hospital indoor documents i.e. Patient chart, operation     notes, surgeons visual estimation of blood loss etc will be used as study tool. Ethical     clearance will be obtained from Institutional Review Board of BSMMU. Written informed consent     will be obtained from the patient or from her legal guardian. Patient confidentiality will be     strictly maintained. No name, address or contact details of the patient will be divulged.   "
67958|NCT02396290|"     Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar   "
67959|NCT02396277|"     Immobilization after radius fracture seems to increase the risk of developing a Complex     regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity     and reduced epidermal nerve density.      The purpose of the study is to determine whether 5-week immobilisation leads to functional     and structural sensory changes, and whether the changes are associated with persistent pain.     The investigators plan an explorative, pilot study on six consenting patients immobilised     after a distal radius fracture.      The baseline measurements will be recorded at the day of or the day after trauma:     Demographics, psychological and physical comorbidity, pain characteristics and intensity,     hand function, health related quality of life (HRQOL), quantitative sensory testing will be     recorded while skin biopsies are analyzed for epidermal nerve fiber density. Following     variables such as pain characteristics and intensity, hand function, health related quality     of life, quantitative sensory testing and skin biopsies will be reassessed when the cast is     removed and two months later.   "
67960|NCT02396264|"     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women     characterized by chronic anovulation, hyperandrogenism and insulin resistance. Available     guidelines recommend lifestyle intervention although they do not suggest the best dietetic     regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the     effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized     normocaloric Diet in normal weight women with PCOS.   "
67961|NCT02396251|"     A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study     is designed to assess efficacy with regard to aesthetic midface augmentation and safety after     treatment with HA product.   "
67962|NCT02396238|"     The primary objective of this study is to assess the safety and efficacy of the Celution     Device in the processing of an autologous graft consisting of adipose derived regenerative     cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.   "
67963|NCT02396225|"     Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are compared     after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of voriconazole     tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day, respectively.   "
67994|NCT02395744|"     The purpose of the COPPER - B study is to assess the feasibility, safety, and initial     efficacy of paclitaxel administration using the OPC for the prevention of restenosis in     infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, the OPC.   "
67964|NCT02396212|"     This is a phase III study designed to provide efficacy and safety data for canakinumab     administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in     Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA)     data at Week 28 and 48 from this study will support a registration submission of canakinumab     in the indication of SJIA in Japan.   "
67965|NCT02396199|"     The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety     and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium     iCAST™ covered stents in the treatment of abdominal aortic aneurysms.   "
67966|NCT02396186|"     The purpose of this study is to collect data from real-world use with the Glider Percutaneous     Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the     Glider PTCA Balloon for crossing into complex coronary lesions.   "
67967|NCT02396173|"     Background: Orthopaedic trauma are a leading cause of long-lasting sick-leave and persistent     disability. People suffering from persistent sick-leave often need vocational rehabilitation     (VR). Vocational programs are planned to improve the likelihood of returning to work (RTW).     Physical conditioning, professional evaluation and training, as well as psychological and     social interventions are the core of the treatments. Efficiency of these programs is moderate     and there is scope for improvements. For instance, rehabilitation programs tailored to the     individual needs and potentials are called for. However, the allocation remains difficult.     Decision-supportive tools may be convenient to achieve this goal. Recently, the WORRK model     was proposed to assess early on the risk of non-returning to work for those patients. The     main goal of this research is to measure if the WORRK model improves patients' allocation to     different vocational programs according to their non-return to work risk.   "
67968|NCT02396160|"     This study aims to assess the efficacy of a specialized herbal formula, Urox, versus control     over 8 weeks, in a double blind, placebo controlled trial. 150 participants are being     recruited, randomized and administered treatment or placebo for the period of 8 weeks after     initial eligibility screening. Outcome measures include previously validated tools such as     the 3 day symptom diary measuring self-recorded day frequency, nocturia, urgency and     incontinence episodes. Quality of life improvements are being measured using the Incontinence     Impact Questionnaire, Urinary Distress Inventory and the short version of the OverActive     Bladder survey.   "
67969|NCT02396147|"     The purpose of this study is to evaluate the oral bioavailability of two new tablet     formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed     conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the     pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4     Formulation C tablet.   "
67970|NCT02396134|"     This randomized phase II trial studies how well vaccine therapy works in reducing the     frequency of cytomegalovirus severe infections (events) in patients with hematologic     malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the     body build an effective immune response and may reduce cytomegalovirus events after donor     stem cell transplant.   "
67971|NCT02396121|"     The purpose of this study is to evaluate the micronutrient status of malnourished elderly     after oral nutritional supplementation.   "
68005|NCT02395601|"     First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in     patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2.   "
68006|NCT02395588|"     This study will test if standardized care helps patients feel better, if it can be     implemented in rural hospitals, and find out which healthcare processes and outcomes are most     important to heart failure patients.   "
68007|NCT02395575|"     The primary objective of this study is to evaluate the impact of the result of the Prosigna     Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone     therapy) in patients suffering from early-stage breast cancer.   "
68008|NCT02395562|"     Several studies show that the incidence of skin cancer parallels the length and depth of     immunosuppression. This study will analyze the correlation of viral reactivation and skin     cancer in organ transplant recipients.   "
67972|NCT02396108|"     The current standard of care for stage I-III HER2-positive breast cancer is adjuvant     chemotherapy combined with 1 year of adjuvant trastuzumab. Neoadjuvant chemotherapy in early     stage breast cancer has the advantages of i) tumour downsizing, ii) higher breast     conservation rates, and iii) enabling the evaluation of tumour biology. Pathologic complete     response following neoadjuvant chemotherapy has been shown to be an independent, strong     predictor of outcome in operable HER2-positive breast cancer. The addition of neoadjuvant     anti-HER2 therapy to chemotherapy results in a 2-3 fold increase in pCR rates in operable     HER2-positive breast cancer. However, the optimal neoadjuvant regimen has not been defined in     HER2-positive breast cancer. The investigators recently completed a phase II study of     neoadjuvant lapatinib combined with weekly paclitaxel/ carboplatin in stage I-III     HER2-positive breast cancer. Preliminary analysis suggested that the utility of the regimen     might have been limited by its unfavourable efficacy/ toxicity ratio. ASLAN001 is a small     molecule tyrosine kinase inhibitor against HER1, HER2, and HER4. Preclinical data have shown     ASLAN001 to be more potent than lapatinib and neratinib in inhibiting HER1 and HER2, and     early phase clinical studies have demonstrated superior pharmacokinetics and pharmacodynamic     target inhibition compared to lapatinib. Furthermore, ASLAN001 has demonstrated a better     safety profile than lapatinib in early phase studies.      • The investigators hypothesize that ASLAN001 combined with paclitaxel/carboplatin will     induce favorable pathological complete response (of at least 30%) in stage I-III HER2     positive breast cancer, with a more favourable safety profile than lapatinib combined with     paclitaxel/carboplatin.   "
67973|NCT02396095|"     Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be     eligible to participate in a study investigating pregnancies that result from frozen eggs.   "
68015|NCT02395471|"     This study will assess the Minimally Invasive Esophageal Cytology Collection System in     Patients with Barrett's Esophagus or GERD Symptoms.   "
68016|NCT02395458|"     Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic     strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with     metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14     days.   "
67974|NCT02396082|"     This is a 24-month, prospective, single- blind, randomized controlled trial evaluating the     MIND at Home-streamlined dementia care coordination intervention (called MIND-S) in a cohort     of 300 community-living persons with dementia and their family caregivers in the Greater     Baltimore area. Participants receiving MIND-S will get 18 months of care coordination by an     interdisciplinary team comprised of trained memory care coordinators (non-clinical), a     psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components:     identification of needs and individualized care planning (persons with dementia (PWD) and     care giver (CG) needs); dementia education and skill building; coordination, referral and     linkage of services; and care monitoring.Participants in the comparison group will receive an     initial in-home needs assessment and will be given the written results along with any     recommendations for care that are indicated.   "
67975|NCT02396069|"     Double blind, randomized, placebo control, multiple dose, dose escalation study   "
67976|NCT02396056|"     Guided bone regeneration (GBR) procedures have significantly evolved over the last 20 years.     Significant advances have been made with various barrier membranes with or without the use of     bone grafts and other materials. Some of the main limitations of non-resorbable barriers     included cytotoxicity and need for removal, which can adversely affect the regenerated bone     volume. Similar GBR success has been documented extensively with cell occlusive resorbable     barriers membranes. Recently, the investigators demonstrated supracrestal bone regeneration     in guided tissue regeneration procedures in humans with the use of novel perforated barrier     membrane (MPM). The perforation allows mesenchymal stem cells and other progenitor cells     present in the gingival tissues to migrate into the osseous defect and contribute to the     osseous regeneration potential.      The objective of this study is to investigate the GBR potential of MPM in alveolar ridge     defects, relative to a similar occlusive barrier. Ten non-smoking patients that need     localized alveolar ridge augmentation prior to implant placement will be included into the     study. Patients will be divided into two groups, as follows: occlusive bovine collagen     membrane (OM control group, 5 patients) and modified bovine perforated collagen membrane (MPM     test group, 5 patients). All sites will be grafted with mineralized cortical bone allograft     and when needed cortical bone pins will be use for site stability. A Cone Bean (CT) will be     obtained prior to surgery and 6-8 months post treatment from which volumetric width changes     will be quantify. A bone biopsy will be obtained at the time of implant placement (~6-8     months) to determine residual graft particles and new bone formation. Dimensional width     changes will be assess at 6-8 months during re-entry for implant placement. Soft tissue     healing will be assessed at 2, 4, 8, 16 weeks and 6 months.      This study can potentially impact current bone augmentation techniques and may lead to the     modification of existing commercial membranes that will enhance site development prior to     implant placement. The contribution of progenitor cells to the osseous defect might lead to     greater bone formation and possible faster wound healing.   "
67977|NCT02396043|"     This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma     (T-LBL) according to modified BFM-95 regimen for acute lymphoblastic leukemia.   "
67978|NCT02396030|"     Eclampsia is an obstetric emergency capable of prophylaxis. To prevent and control seizures,     there is no doubt that the magnesium sulfate (MgSO4) is the ideal drug. However, there are     still questions regarding its use and dose. The scheme and the optimal time of administration     remain to be elucidated. The objective of this trial is to compare the effectiveness and     safety of intravenous magnesium sulfate in the maintenance phase 1g / h versus 2 g / h to     prevent eclampsia in pregnant and postpartum women with severe preeclampsia (pure or     superimposed).   "
67979|NCT02396017|"     To compare the small bowel cleanliness for wireless capsule endoscopy using two different     Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion     versus in a split-dose fashion).   "
67980|NCT02396004|"     Aim of study:      To conduct an observational study to collect cerebral and renal perfusion data through NIRS     before and after treatment of PDA by medication or by PDA ligation. The data post treatment     would form the basis for normative baseline data in VLBW preterm newborn babies, particularly     in the Asian population.      Study population/inclusion criteria:      VLBW newborn babies with hemodynamically significant PDA by echocardiography.      Exclusion criteria:      Major malformations Moribund patients   "
67981|NCT02395991|"     The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA     administration by obtaining continuous dynamic T1 weighted image data.   "
67982|NCT02395978|"     The purpose of this study is to evaluate the safety and efficacy in patients with major     depressive disorder.   "
67983|NCT02395965|"     The SPECIFIC AIM of this research study is to evaluate the utilization, effectiveness, and     safety of osteopathic manipulative treatment (OMT) using data collected from patients     receiving OMT in the clinical setting within the established practice-based research network     DO-Touch.NET.      . The HYPOTHESES of this research study are the following:        -  OMT is primarily used in the treatment of musculoskeletal pain disorders.        -  Patients receiving OMT will have decreased symptoms and improved quality-of-life.        -  The most common side effect reported by patients receiving OMT will be muscle soreness.   "
68009|NCT02395549|"     This study is designed to investigate the efficacy, safety and tolerability of MTC896 Gel in     subjects with acne. In this study, MTC896 Gel will be applied at 3 concentrations, twice     daily (bid) for 12 weeks and compared against a vehicle control.   "
67986|NCT02395926|"     Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the     brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure     and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine     glycerophosphate. Choline alfoscerate Colin normalization of nerve pathways, nerve cell     membrane play and acetylcholine receptor function secondary symptoms caused by     cerebrovascular deficiency and indirectly through activation of metabolism, has a     degenerative effect on the brain organic mental syndrome.      Currently marketed oral choline alfoscerate received a geriatric cognitive impairment,     secondary symptoms and degeneration, or soft capsule is authorized to prescription drugs for     degenerative brain organic mental syndrome caused by cerebrovascular deficiency. Gliatilin     soft capsules containing 400 mg per 1 capsule 2-3 times one days're supposed to take when     considering optimal convenience and efficiency of the drug in patients with the development     of sustained release formulations that can be maintained for a long period of time, a certain     concentration is required. Accordingly, the modern drug by reducing the frequency of     administration a day circuit is to develop a sustained release formulation of choline     alfoscerate HT-003 600 mg medication compliance for the purpose of raising. 2 tablets at a     time (600 mg x 2) can be taken one day to 1200 mg is required by taking.      Therefore, for the development of sustained release formulation, the test in healthy adult     male volunteers targets choline alfoscerate soft capsule formulation of 400mg 3 times per 1     day and sustained-release tablet 600mg 2time per 1 day, pharmacokinetic properties and safety     of a single dose should be evaluated when compared.   "
67987|NCT02395913|"     Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally     administered as a salt composed of an acid-base as a compound that was synthesized by and     chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to     the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows     the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and     by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory     activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state     is allowed to recuperate or extended.      It was developed to improve compliance improve pharmaceutically Surfolase     capsule(Acebrophylline 100mg) that intake twice daily 100mg to Surfolase CR(Acebrophylline     200mg) that intake once daily 200mg   "
67988|NCT02395900|"     To study the effects of Flaxseed supplement on lipid profile, liver enzymes, inflammatory     factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50     patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be     randomly allocated to receive placebos or 30 grams Flaxseed powder for 12 weeks; both groups     will be advised to adherence the investigators' diet and exercise program too. At the first     and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers,     and liver fibrosis will be assessed and compared between groups.   "
67989|NCT02395809|"     Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are     compared with a healing rate over 92%. However, the most serious complication of this     procedure is anal incontinence. To overcome these problems, continued efforts are being tried     to find less invasive treatments modalities for anal fissure that is as effective as surgical     therapy with lower morbidity.   "
67990|NCT02395796|"     Epidural analgesia is highly effective for labor pain relief and is widely chosen by pregnant     patients. However, placement of the epidural needle can be challenging in pregnant patients     due to lax tissue ligaments and edema so that the traditional loss of resistance method (LOR)     used to find the space may be subtle leading to retries which may delay onset of analgesia as     well as increase the risk of complications. The ability to transduce a pulsatile pressure     waveform from epidural needles placed in non-laboring patients correlates highly with     successful placement of the epidural needle. We wish to evaluate the efficacy of obtaining a     pulsatile pressure waveform with correct epidural needle placement in laboring women.   "
67991|NCT02395783|"     Neurocognitive sequelae observed in preterm represent a major health problem for which there     is no preventive treatment approved to date. These effects are the result of a multifactorial     brain damage occurring in developing prenatal and perinatal period. Melatonin, the principal     hormone secreted by the pineal gland has neuroprotective properties in various experimental     animal models of perinatal brain damage level. This hormone readily crosses the placental     barrier, its antenatal administration would have a neuroprotective effect in the case of     preventive preterm birth before 28 weeks of amenorrhea.      The objective of this study determine the dose of melatonin administered parenterally in     prenatal maternal in preterm labor to reduce brain damage in the white matter detected by     diffusion tensor imaging (DTI) with statistical spatial analysis (TBSS) to the theoretical     term of 40 weeks in children born prematurely.   "
67992|NCT02395770|"     Objectives: Evaluate the effects of a rehabilitation program based on movement training on     symptoms, functional limitations and acromiohumeral distance (AHD) in individuals with SPS.      Methods: Twenty-five participants with SPS participated in a 6-week program. Outcomes of both     groups were evaluated at baseline and 6 weeks. Changes in symptoms and functional limitations     were assessed. Changes in AHD for both groups were assessed using ultrasonographic measures.   "
68010|NCT02395536|"     The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™     insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure     performed in the in-office setting is as safe as LINQ™ insertions performed in the     traditional hospital setting (operating room, cardiac catheterization or electrophysiology     (EP) laboratory).   "
68011|NCT02395523|"     This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy     (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.   "
68012|NCT02395510|"     The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult     population with a diagnosis of PD. PD is generally treated with benzodiazepines which are     very effective but have a high risk for addiction, fall, and cognitive impairment. There is     still a need for better treatment for PD for longer term use. There are other drugs within     the SSRI/SNRI class which have proven to be effective in treating patients with this     diagnosis.   "
68346|NCT02391155|"     In this study, the investigators aimed to evaluate to the efficacy of the needle type used in     follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.   "
67993|NCT02395757|"     Age-related macular degeneration (AMD) is an acquired retinal pathology affecting the central     region of the retina responsible for discrimination between high spatial frequencies     (reading), colour vision and the central visual field. The loss of visual acuity which occurs     with the onset of AMD significantly affects patients' quality of life. In developed     countries, AMD is the leading cause of vision impairment for people aged over 50 years. Its     prevalence in Europe in people aged over 65 years is 3.3%. In France, around 2 million people     suffer from this disease.      In the first stage of the disease it is known as age-related maculopathy (ARM). This early     form of the disease can develop into intermediate AMD (stage 3 of the AREDS classification)     and then advanced AMD (stage 4 AREDS), which can be atrophic or exudative. In cases of     exudative AMD, the intravitreal administration of anti-VEGF drugs can limit the disease's     progression.      It is therefore vital to adopt a strategy to assess the stage of the disease and provide the     appropriate care management at the earliest possible stage. This is even more important for     patients with advanced AMD in one eye and intermediate AMD in the fellow eye, as the risk of     the fellow eye progressing to the advanced stage within 5 years is between 35% and 53%.      Microperimetry is a promising new diagnostic method which combines measurements of light     sensitivity, loss of fixation and the anatomy of the retina. It offers a new approach to the     functional assessment of retinal damage in patients with AMD, as it precisely correlates     anatomical and functional modifications by measuring the loss of sensitivity and macular     fixation. It has been shown that the more advanced the patient's AMD is, the further the     parameters measured by microperimetry are from the norm.      The investigators want to assess the MAIA™ as a means of screening for AMD progression in     patients with a high risk of progressing to a more advanced stage (patients presenting one     eye with advanced AMD and a fellow eye with stage 3 AMD according to the AREDS     classification). The research hypothesis for our proposed study is that the parameters     measured using microperimetry will already show abnormal results in the study eye prior to     progressing to a more advanced stage of the disease. The use of these microperimetric     parameters as predictor of progression would therefore make it possible to screen eyes likely     to develop from intermediate to advanced AMD at an earlier stage, and subsequently provide     patients who need it with earlier follow-up, preventive treatment or adapted, personalized     rehabilitation as appropriate.   "
71278|NCT02352779|"     This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related     fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce     cancer-related fatigue in breast cancer survivors.   "
67995|NCT02395731|"     This Center for Medicare and Medicaid funded health care innovation award will implement the     MIND at Home dementia care coordination program (called MIND at Home-Plus) through two     community-based service agencies (Jewish Community Services, Johns Hopkins Home Care Group)     to rapidly improve the ability of 600 dually eligible older adults with dementia in the     Baltimore region to remain at home while improving care quality, enhancing quality of life,     and reducing total health care costs. MIND at Home participants receive an in-home needs     assessment followed by up to 18 months of care coordination aimed at filling unmet needs.   "
67996|NCT02395718|"     To evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated in     a Quick Diagnostic Unit (QDU) compared to the Department of Internal Medicine (DIM). A QDU is     a medical Short Stay Unit (SSU).   "
67997|NCT02395705|"     The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal     squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for     esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy     with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total     2-field lymph node dissection improves the overall survival of thoracic esophageal cancer     patients.   "
67998|NCT02395692|"     This phase II trial studies how well methoxyamine works when added to standard temozolomide     in treating patients with glioblastoma that has come back. Drugs used in chemotherapy, such     as methoxyamine and temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading.   "
67999|NCT02395679|"     Malignant mesothelioma is an aggressive pleural disease, related to asbestos exposure. At     present, cytotoxic chemotherapy is the only evidence based treatment for the disease, but     efficacy is limited. The investigators have shown both in a murine model, as for the first     time in patients, that dendritic cell-based immunotherapy induces tumor specific T-cell     responses. However the quality and quantity of the autologous tumor cell lysate to load the     dendritic cells was a major impediment for these trials. The investigators have now developed     a clinical grade allogeneic tumor cell lysate which can be used to load dendritic cells of     patients.   "
68000|NCT02395666|"     The purpose of this research study is to evaluate a new investigational drug to prevent     reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The     objectives of this study will be to monitor for safety and look at efficacy of DFMO.      The safety of the proposed dosing regimen in this trial will be tested by an on-going     risk/benefit assessment during the study. A patient benefiting from treatment, not     progressing on therapy, and in the absence of any safety issues associated with DFMO may     continue on treatment up to 27 cycles with the expectation that there will be an overall     clinical benefit.      The procedures involved in this study include Medical history, Physical exam, Vital signs     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the     tumor(s), meta-iodobenzylguanidine (MIBG) scans, and Bone marrow aspirations. All of these     tests and procedures are considered standard of care for this population. Drug administration     is also part of this protocol, including an investigational new drug called DFMO.      The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day     while on study. There will be 27 cycles. Each cycle will be 28 days in length.   "
68001|NCT02395653|"     The objective of this study is to evaluate the safety and clinical utility of the active,     SSEC fentanyl 40 mcg for the management of acute, postoperative pain in pediatric patients.   "
68002|NCT02395640|"     This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen     in the first-line treatment of advanced gastric cancer patients.   "
68003|NCT02395627|"     The investigators propose a randomized two arm trial, using Simon's 2-stage design, in ER+     patients with therapy resistant breast cancer to test the optimal sequence and dosing of     epigenetic immune priming in hormone therapy resistance breast cancer. A third arm (Arm C)     will include ER-negative patients who will follow the concurrent priming, but exclude     tamoxifen. The two arms all include vorinostat, TAM and pembrolizumab to evaluate        -  Sequential priming - begin pembrolizumab in Cycle 1 (Arm B and Arm C) and,        -  Concurrent priming with maximal dosing of both epigenetic and immune modulators- begin          pembrolizumab on day 1 in Cycle 2 (Arm A)   "
68004|NCT02395614|"     The investigators intend to perform a prospective randomized study and compare the incidence     of surgical wound infection between mastectomy wounds irrigated with triple antibiotic     solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast     reconstruction. Each patient will receive triple antibiotic solution on one breast and the     CHG on the other breast.   "
68013|NCT02395497|"     Injuries to the external genitalia are of great concern to the military with emphasis being     placed on the surgical reconstruction and psychological health of these Wounded Warriors.     However, despite significant surgical advances in microvascular surgery and autologous free     tissue transfer, conventional reconstructions cannot truly replace the complicated structures     and functions of the penis including the urethra, erogenous sensation, and erectile corporal     bodies. Conventional reconstruction poses several challenges: patients may not have     sufficient donor tissue (i.e., the forearm or thigh) due to other injuries or previous     surgery; multiple operations are often needed to restore the neophallus; the final     reconstruction only approximates the penis' native form; recreating the urethra is     challenging and the new urethra is prone to stricture and fistula formation; the erectile     function necessary for sexual intercourse is often lacking; and insufficient protective     sensation can lead to penile implant extrusion, infection, and subsequent explantation or     loss of the reconstruction.      For these reasons, the investigators propose the current clinical trial to determine     functional outcomes and quality of life (QOL) for Wounded Warriors and civilians who choose     to undergo penile allotransplantation. The investigators will combine extensive experience     performing total penile reconstruction in a large population affected by congenital,     traumatic, and therapeutically extirpated GU deformities and expertise in reconstructive     transplantation using an immunomodulatory protocol to implement this study. The investigators     anticipate that penile transplantation can potentially replace like with like, restoring     the appearance, anatomy, and function of the recipient in a manner far superior to autologous     reconstruction. This project will establish the ability to perform penile allotransplantation     using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty     patient results.      Study Design: This is a non-randomized subject self-controlled clinical trial to implement a     cell-based immunomodulatory protocol for penile allotransplantation. An intermediate     deliverable is achieving allograft survival and functional return with reduced     dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus)     immunosuppression. The long-term deliverable and goal is to demonstrate equivalent or     superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients     12-60 months post-transplant.   "
68014|NCT02395484|"     Constipation is a heterogeneous and multifactorial disease, influenced by a number of     different genetic and environmental factors. By applying the standard two-stage GWAS strategy     to design and carry out a metagenome-wide association study (MGWAS) to find the relationship     between gut microbiota and constipation, to identify disease-associated metagenomic markers.   "
68017|NCT02395445|"     Endotracheal intubation is usually required to allow unrestricted surgical approach. The     Macintosh laryngoscope is the standard method. However in certain situations as difficult     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic     intubation is the gold standard in this scenario, however sometimes it is not possible due to     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,     Barcelona, Spain) has been designed specifically for the airway management. However, despite     its use in clinical practice, there are no comparative studies regarding direct laryngoscopy   "
68018|NCT02395432|"     Endotracheal intubation is usually required to allow unrestricted surgical approach. The     Macintosh laryngoscope is the standard method. However in certain situations as difficult     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic     intubation is the gold standard in this scenario, however sometimes it is not possible due to     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,     Barcelona, Spain) has been designed specifically for the airway management. However, despite     its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.   "
68019|NCT02395419|"     Endotracheal intubation is usually required to allow unrestricted surgical approach. The     Macintosh laryngoscope is the standard method. However in certain situations as difficult     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic     intubation is the gold standard in this scenario, however sometimes it is not possible due to     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,     Barcelona, Spain) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed     specifically for the airway management. However, despite their use in clinical practice,     there are no comparative studies.   "
68020|NCT02395406|"     Endotracheal intubation is usually required to allow unrestricted surgical approach. The     Macintosh laryngoscope is the standard method. However in certain situations as difficult     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic     intubation is the gold standard in this scenario, however sometimes it is not possible due to     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,     Barcelona, Spain) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed     specifically for the airway management. However, despite their use in clinical practice,     there are no comparative studies.   "
68021|NCT02395393|"     Bronchoscopy-guided tissue sampling is a central technique in many diseases including     diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or     chronic rejections following lung transplantation. Confocal fluorescence microscopy is a     novel technique used for real-time microscopic imaging of proximal and distal airways,     microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy     images of airways and alveolar structures during standard bronchoscopy could help recognize     and classify the presence or absence of acute or chronic rejection in lung transplant     recipients.   "
68022|NCT02395380|"     Colic and rectal resection represents a majority of hospitalizations in visceral surgery. The     objective of this study was to evaluate the prognostic of inflammatory markers dosage (CRP,     procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and     on the length of stay.   "
68023|NCT02395367|"     The aim of the study is to construct a register system of oral and maxillofacial malignant     tumors based on a prospective, observational, real-world study in north Chinese population.   "
68024|NCT02395354|"     This study will be a multicentre randomized controlled trial to assess the efficacy between     balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of     stenosis in Crohn´s Disease.   "
68025|NCT02395341|"     Postmenarchal female cancer patients scheduled to undergo cancer therapy may enroll in this     study to assess changes in existing and novel surrogate measures of fertility potential     before, during and after chemotherapy. Measures of fertility potential to be tested include     ultrasound imaging for antral follicle counts and ovarian volumes, endocrine evaluation, and     assessment of oxidative stress.   "
76293|NCT02287207|"     The purpose of this pilot study is to determine the effect of transcranial direct current     stimulation (tDCS) on brain activity and fine motor skills in patients with Parkinson's     disease compared to healthy controls.   "
68026|NCT02395328|"     This study consists of a one-year randomized controlled trial investigating the impact of     mobilized care workers trained and supported by Futures Families, a South African non-profit     organization, that provide biweekly home visits to families with orphans and vulnerable     children (OVC) in Tshwane (aka Pretoria) townships, South Africa. Future Families takes a     family-based approach to addressing the needs of OVC by providing caregivers with     information, psychosocial support, and access to external services. Caregivers will     participate in a survey providing information on their personal wellbeing as well as key     indicators reflecting the wellbeing of each child under their care. Newly enrolled caregivers     will be randomly assigned to either program participation beginning in late 2014 or to     delayed participation following the impact survey about one year later. The data will be used     to test for changes in a set of key program indicators pertaining to child protection, HIV     prevention, psychosocial wellbeing, education and early childhood development. This study     aims to strengthen the evidence base for effective family centered programming to address the     needs of HIV-affected children and their caregivers.   "
68040|NCT02395146|"     Thyroid surgeons place an enormous amount of importance and rightly so to the preservation of     the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the anatomy     of the nerve and meticulous dissection technique and intraoperative identification of the     nerve are crucial to the anatomic and functional integrity of the nerve. The use of     intraoperative neural monitoring to aid the surgeon in the identification of the RLN has     gained acceptance and is considered standard practice in several units. However, lesser     emphasis has been placed historically on the identification and preservation of the external     branch of the superior laryngeal nerve (EBSLN) during thyroid surgery. The EBSLN supplies the     cricothyroid muscle that controls pitch variation during phonation. Unlike damage to the     recurrent laryngeal nerve which manifests readily as vocal cord paralysis, intraoperative     damage to EBSLN is difficult to assess postoperatively as visual assessment of the larynx is     not indicative of the integrity of the nerve. Injury of the EBSLN can cause weakness or     complete paralysis of the ipsilateral cricothyroid muscle. Patients may report a deeper voice     or an inability to produce high pitched sounds.      Patients may also complain of weakness, tightness of the voice, and require extra effort to     speak. Of note, voice changes with EBSLN injury are subtle in the general population but can     be devastating in patients who depend on their voice for a living. Importantly, EBSLN injury     is reported in upto 50% of thyroid surgery in contrast to 12% of recurrent laryngeal nerve     injury during thyroid surgery. The new guidelines published in the Laryngoscope recommend     routine intraoperative neural monitoring of EBSLN. The Investigators have a functional system     in use currently for monitoring recurrent laryngeal nerve intraoperatively and propose to     study the impact of monitoring the EBSLN using the same neural monitoring device to improve     voice results following thyroid surgery.   "
68027|NCT02395315|"     Type 2 Diabetes Mellitus (DM) is a very prevalent metabolic disorder in the adult population     affecting roughly 17.7 million people in the US alone. The harmful effect of DM on implant     integration and survival has been attributed to vascular complications in the alveolar bone     that lead to compromised blood supply and decreased bone density. Nonetheless, the specific     detrimental effects of DM in the alveolar bone have not been investigated in humans.      People with DM generally lose more teeth than persons without diabetes, but implant placement     in not well controlled diabetics is not routinely performed due to the lack of relevant     evidence and the risk for implant failure and associated complications. Chemically modified,     micro-rough, hydrophilic (SLActive®) titanium implant surfaces have been shown to accelerate     osseointegration of dental implants placed in diabetic animals. It has been hypothesized that     this enhanced biologic response is due to the biocompatibility and hydrophilicity of the     surface that actively attracts blood and is populated by progenitor cells, and growth factors     that improve stromal cell differentiation.      Hypotheses:      It is hypothesized that hyperglycemia results in compromised vascularity in the mandible.     Thus, hydrophilic TiZr implant surfaces (Roxolid®) that actively attract fluids and possess     excellent osteoconductive properties, may enhance peri-implant bone response in diabetic     patients to levels comparable to well-controlled diabetics.   "
68028|NCT02395302|"     The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4     weeks of treatment using a dual action pneumatic compression device.   "
68029|NCT02395289|"     The purpose of the study is to examine the effects of cognitive-based compassion training     (CBCT), a meditative practice based on Buddhist teachings, on long term emotional well-being     and immune system improvement with people living with Human Immunodeficiency Virus (PLHIV).   "
68030|NCT02395276|"     Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most     common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live     births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII)     as result of hemodynamic instability in the perioperative period. Similar insults in adults     with cardiac arrest or infants with neonatal asphyxia, was successfully treated with     hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely     an effective treatment for HII in children with cardiac anomaly, it also carries a risk for     bleeding or infection of the surgical wound. In this randomized control trial, hypothermia     treatment will be compared to normothermia treatment of patients in the pediatric cardiac     intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect     will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG,     neurological evaluation coagulation and infection evaluation in the acute phase and by     developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with     minimal risks may open the door for the implementation of hypothermia as a standard care in     PCICUs.   "
68031|NCT02395263|"     The purpose of this study is to determine whether Yuxintine Capsule in different doses are     effective in the treatment of Depression.      And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in the     Chinese Patients with Depression.   "
68032|NCT02395250|"     The purpose of this study is to determine whether autologous T cells bearing chimeric antigen     receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for patients     with relapsed or refractory hepatocellular carcinoma (HCC).   "
68033|NCT02395237|"     The purpose of this study is to assess, after single oral administration under fed     conditions, the bioequivalence between the two batches of the same glimepiride/metformin     hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release     combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.   "
68034|NCT02395224|"     The main objective is to provide original research results that may change clinical practice     related to metastatic colorectal cancer. The study will evaluate treatment and patient care     at different stages of the disease trajectory and the use of health care for this large group     of patients. It will be possible to compare the effectiveness of chemotherapy, radiotherapy     and symptomatic treatment given to real life patients with the efficacy reported in     randomised clinical trials. By using longitudinal information on imaging, biomarkers,     clinical staging and place of care it will be possible to improve patient classification at     various stages of the disease. Based on this, a more appropriate, individualized treatment     for colorectal cancer may be recommended during the phases of the disease trajectory.     Participation in this project will not influence the treatment for colorectal cancer. All     patients will be treated and followed-up according to current regional and national     guidelines.   "
68035|NCT02395211|"     The aim of this study is to evaluate feasibility of a proprioceptive stimulation under visual     feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment     in sub-acute stroke patient with Complex regional pain syndrome.   "
68036|NCT02395198|"     The aim of the present study is to estimate the national annual prevalence and incidence of     current hepatitis C virus (HCV) infections among opioid dependent individuals in opioid     substitution treatment (OST) based on a representative sample of approximately 2,500     outpatients in 100 substitution facilities across Germany. Furthermore, the study aims to     describe factors influencing HCV therapy initiation and seroconversion during OST.   "
68037|NCT02395185|"     While it has been shown that sucrose or milk ingestion decreases pain responses in heel     sticks, no study up to this point has determined the best intervention for decreasing the     pain response during casting for clubfoot deformity.      The goal of this study is to investigate the effect of three different non-pharmacologic     interventions (sucrose, milk, water) on pain response during clubfoot casting.      This study will allow us to discern the best non-pharmacologic intervention for pain control     during clubfoot casting and to provide a more pleasant, comfortable experience for patients     and families.   "
68038|NCT02395172|"     To demonstrate superiority with regard to overall survival of avelumab versus docetaxel in     subjects with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC)     after failure of a platinum-based doublet.   "
68039|NCT02395159|"     Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster     in vascular surgery patients.   "
68042|NCT02395120|"     The study is a multi-site, double blind, parallel arm, community-based randomized controlled     trial (phase III RCT) to evaluate the effectiveness of new referral approaches to increase     receipt of dental care among inner-city urban and rural elementary school children who were     screened at school and have restorative treatment needs. The study has 5 arms: The     experimental intervention is the use of a theoretically driven CSM referral letter alone, the     letter plus a Dental Information Guide, a reduced CSM referral letter alone, or a reduced CSM     referral letter plus a reduced Dental Information Guide. The control strategy is the use of a     standard referral letter. All participating K-4 grade children will receive a screening at     the beginning of the school year and at the study end point 7 months later to determine if     the child received dental care.      The primary aim is to evaluate the effectiveness of experimental (new) versus standard     referral approach given to parents/caregivers in increasing receipt of dental care among     their children in grades K-4. The secondary aim is to assess changes in parent/caregiver     illness representation/perception and behavioral intention between enrollment (beginning of     school year) and follow-up (end of school year) to understand the underlying mechanisms of     the new vs. standard referral approach that result in receipt of dental care.      The hypothesis is that CSM-based interventions will increase receipt of dental care compared     to the standard referral letter.   "
68043|NCT02395107|"     Aortic stenosis results in increased filling pressures of the heart. Size and function of the     left atrium may be a marker for more advanced heart disease (heart failure) in patients with     severe aortic stenosis, not presenting any apparent symptoms.      The goal of this study is to establish the importance and possible implications of left     atrial dilation in asymptomatic patients with aortic valve stenosis.   "
68044|NCT02395094|"     Children can experience high levels of anxiety immediately prior to surgery. In fact, this     can be the most stressful part of the whole surgical experience for children. Anxiety before     surgery is associated with problems after surgery; such as short-term increased need for pain     medication and long-term sleep disturbances or behaviour change. Child Life, a program run in     some North American children's hospitals has developed ways to reduce children's anxiety     prior to surgery. These techniques can include role-play or story books amongst others.      In this study, the investigators aim to look at the benefits of the Child Life techniques on     anxiety levels of children and their caregivers just prior to receiving anesthesia in the     operating room. The study will include children between the ages of 3 and 10 years old,     needing day case surgery lasting less than 2 hours, and having never had surgery before. They     will be randomly allocated to either not receive any intervention by Child Life or to receive     Child Life intervention in the period prior to their surgery, when they are waiting in the     Surgical Day Care Unit. Anxiety levels of the children and their caregivers will be measured     as they arrive in the hospital and immediately prior to anesthesia, to see if there is a     lower level of anxiety in the group receiving the Child Life intervention.   "
68045|NCT02395081|"     A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU,     or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The     Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16     weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also     be determined. The investigators will generate preliminary data regarding Vitamin D intake     and hypertensive disorders, blood pressure, and arterial function measured by tonography. The     investigators will independently test blood pressure and proteinuria to identify preeclampsia     cases.   "
68059|NCT02394899|"     There are all significant risk factors for poor early cognitive development and, as such,     neurocognitive deficits have been demonstrated in pre-school children with sickle cell     disease (SCD). This project assesses the efficacy of using an evidence-based early     stimulation program, combined with components to help parents cope with stress, delivered     during six routine monthly clinic visits to parents of children with sickle cell disease. It     is hoped that this innovation will improve parental psychological outcomes, as well as child     developmental outcomes.   "
68046|NCT02395068|"     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in     the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting     tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head and     neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the     registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small     cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are     ongoing all over the investigators' country. The main purpose of this study is to evaluate     the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with     solid tumors.   "
68047|NCT02395055|"     This clinical study is a phase 1 study which carried out to establish the pharmacokinetic     equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar     candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous     injection in healthy volunteers.   "
68048|NCT02395042|"     This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with     Hunner's lesions.   "
68049|NCT02395029|"     Prospective, open labeled, non-randomized, study to be conducted at a single center. Ten     subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells     (PMD-MSCs) into the penis for the treatment of Peyronie's Disease. Follow up visits will be     conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for     re-injection at 3 months and/or 6 months as determined by the clinician based on patient     reported treatment satisfaction.   "
68050|NCT02395016|"     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck     (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ     trial designed to assess overall survival（OS）of the combination of Nimotuzumab administered     concurrently with Gemcitabine in patients with RAS wild type of locally advanced or     metastatic pancreatic cancer   "
68051|NCT02395003|"     Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2     diabetes. The present studies will focus on determining what might cause fat to accumulate in     the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to     develop in obese adolescents.   "
68052|NCT02394990|"     This study is a randomised controlled trial of a new brief intervention with young (16-29)     adult male patients who have a facial injury sustained as a result of interpersonal violence     (fighting or assaults). It will be undertaken at the Maxillofacial outpatient trauma clinic     at the Southern General Hospital, Glasgow. The major risk factors associated with facial     injury in Scotland are male gender, young age, interpersonal violence and alcohol. Previous     research with facial injury patients attending this clinic has shown that an Alcohol Brief     Intervention (ABI) is effective in helping reduce alcohol consumption, so all patients are     now offered ABI as standard practice. ABI is delivered by trained nurses from Addiction     Services. This will not be withdrawn. In addition we wish to offer some patients a Violence     Brief Intervention (VBI). This will be delivered by the same nurses who deliver the ABI. The     study is randomised so only those selected at random will receive this extra intervention and     all others will receive treatment as normal (ABI only). VBI is a short psychological     intervention which uses Brief Motivational Interviewing (BMI) to encourage reflection of     involvement in violence and consideration of strategies to avoid future violence. The     intervention also compares participants' attitudes towards violence to those of their peers.     The intervention takes about 15 minutes, and patients will be involved for an additional     30-45 minutes longer than normal when they attend the clinic, including consent and baseline     data collection. Patients will be followed up by telephone at 1, 3 and 6 months, and asked a     suite of questions which will take approximately 15 minutes on each occasion. We wish to     determine whether a VBI of this type has any effect on attitudes to violence or propensity     for involvement in violence or on reinjury, examined through self report measures and     routinely collected health and criminal justice data at 12 months post intervention.   "
68053|NCT02394977|"     The investigators conducted a randomized, controlled, single-blinded study of patients     undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic     teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. The intervention and     control groups were labeled group 1 and 2 respectively. The assessment tool was scored by the     principle investigator and an ICU nurse. The data analyzer was blinded to group randomization     and was not present during CPR.   "
68054|NCT02394964|"     The immune system is influenced by the commensal microbes that live in the gut and on the     skin. This study aims to characterize the microbiota of subjects with autoimmune disease in     order to determine whether certain microbial species may cause or worsen immune-mediated     diseases   "
68055|NCT02394951|"     The investigators seek to investigate certain patient characteristics that would predict the     response to a currently approved analgesic, pregabalin, in patients with chronic pain due to     nerve damage caused by chemotherapy. Patients with this painful condition, called     chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of     chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The     investigators will recruit potential subjects from both the Siteman Cancer Center and the     Washington University Pain Management Center. Those patients who meet the inclusion and     satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and thermal     sensitivity testing on their extremities, will provide quality of life information by     completing questionnaires and will receive pregabalin followed by placebo, or placebo     followed by pregabalin [crossover design] in order to assess how well the sensory tests     predict the analgesic effect of pregabalin (compared to placebo).   "
68056|NCT02394938|"     Aims. To describe a new conceptual framework and to test the effectiveness of a recorded     music listening protocol on symptom burden and quality of life in heart failure patients.   "
68057|NCT02394925|"     The primary objective of this study is to determine the retention rate over a two month     period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.   "
68058|NCT02394912|"     The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux     VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF     deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results     of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll     in phase consisting of 2 study subjects per site prior to enrollment into the primary     treatment phase for primary analyses. The purpose of the roll in phase is to assure     compliance with site training on the use of the investigational device and protocol workflow.   "
76294|NCT02287194|"     To document indications for cholangioscopy and clinical utility of the SpyGlass Direct     Visualization System in China when used per standard of practice.      Prospective, Post market, Multi-center, Non-randomized Study   "
68060|NCT02394886|"     This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot     ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived     mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release     growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor     (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an     new option in treating a diabetic foot ulcer.   "
68061|NCT02394873|"     This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep     second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic     adipose-derived mesenchymal stem cells. Adipose-derived stem cells release growth factors     such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which     can enhance wound healing and regeneration of new tissue, finally may provide a new option in     treating a burn.   "
68062|NCT02394860|"     The aim of this study is to assess the influence of the severity of chronic periodontitis on     hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to     identify evolution of several biomarkers and correlate the clinical situation with oral     microflora.   "
68063|NCT02394847|"     Electroconvulsive therapy has been used for many years for different types of physiatric     diseases. General anesthesia is used during the procedure. Different anesthesiologists use     different regimens. The duration of seizure is important in this procedure. The investigators     evaluated the relationship between the dose of propofol and the number of electroconvulsive     therapy and duration of the seizure.   "
68064|NCT02394834|"     The purpose of this study is to investigate biomarkers which may be predictors of efficacy     and safety of treatment with mFOLFOX6 + bevacizumab versus. mFOLFOX6 + panitumumab therapy in     patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.   "
68065|NCT02394821|"     For odor control malignant wounds (MW), use is 0.8% metronidazole solution - second     recommendation scientific and clinical practice. But no this formulation available in Brazil     , and its application to nursing steeps metronidazole tablets , diluted in saline and applied     to the bed of (MW) . Thus , it is used off label for metronidazole ( tablets orally applied     via  topical  - but it is not intact skin or mucosa ) , nursing and eventually manipulate     the solution at bedside , and by law this power is pharmacist bedside and can not be taken .      Family antiseptic chlorhexidine was developed with the purpose of use in infected wounds     called polihexanide ( PHMB ) . In Brazil is now available for hospital and home care ( 0.2 %     Aquasept ® ) use. Evidence reported positive results in controlling infection of chronic     wounds such as pressure ulcers . Although not tested its efficacy in odor control. Thus the     study aims to compare metronidazole solution 0.8 % versus 0.2 % PHMB in odor control , where     , if the results are favorable to PHMB we have a treatment option in odor control with ready     to use formulation and easy access . Evaluate and compare the effectiveness of metronidazole     solution 0.8% and polihexanide solution (PHMB) in odor control in MW. Aims: Evaluate and     compare the time needed for odor control (reduction in days), using metronidazole and PHMB in     MW (primary endpoint); Evaluate and compare the perceptions of patients, nurses and     researcher on the odor MW, using metronidazole and PHMB in the MW; Evaluate and compare the     pain reported by patients during dressing changes, using metronidazole and PHMB in the MW;     Evaluate and compare the quality of life of patients before and after the use of     metronidazole and PHMB in MW. This is a randomized, double -blind study with patients     diagnosed with cancer and patients with MW with odor clinical trial . The sample consisted of     24 subjects divided into 2 groups (control - metronidazole group and experimental group -     PHMB ) , recruited in one cancer hospital in the city of São Paulo (AC Camargo Cancer     Center), which has as protocol description in odor control MW metronidazole . After     acceptance by the subject and return the Statement of Informed Consent signed , randomization     will be done .      For blinding , 0.8 % metronidazole solution will be provided by a compounding pharmacy (after     stability testing of tablet diluted - and then stipulated expiration date) , and PHMB be     bought from the supplier , delivered to the same compounding pharmacy which stores the PHMB     in identical bottles to metronidazole ( only the responsible researcher will know to which     group the subject was randomized ) .      The evaluation of the odor will be taken by 3  employees  and the patient through 3 scales     at zero , four, eight and twelve days ( or earlier if classified as  odorless  by 3     reviewers and the patient ) . Two scales about painful sensations in exchange for healing ,     one on quality of life will be applied to the patient and a specifically on the impact of     odor on the subject's life.      To meet the proposed objectives, the data will be analyzed by: Friedman test to assess the     odor reduction with respect to time; Mann-Whitney (or t test) for comparison of groups and     the Fisher exact test to compare proportions. Data will be presented in the form of frequency     tables for categorical variables and means, standard deviations and position measurements for     quantitative variables. Will also be performed non-parametric analysis of ordinal data, or     parametric analysis with Generalized Estimation Equation for binomial variables, depending on     the data distribution and the sample size.   "
68066|NCT02394808|"     The primary objective of this study is to evaluate the clinical performance of two marketed     silicone hydrogel contact lenses in an Indian population in the following areas:     physiological characteristics, comfort characteristics and vision characteristics.   "
75799|NCT02293668|"     There are different controlled ovarian hyperstimulation protocols utilized in infertility     patients. In this study, our aim is to specifically compare three protocols in poor     responding infertility patients.   "
68067|NCT02394795|"     The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination     therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of     chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable,     advanced/recurrent colorectal cancer.   "
68068|NCT02394782|"     This is a 24-month, observational, prospective, multinational, multicenter study to determine     the relationship between the relapse (percentage of relapse free subjects) and adherence in     subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0     and MSdialog™.   "
68069|NCT02394769|"     This research study is investigating the use of aspirin as a potential chemopreventive agent     to reduce risk of colorectal cancer   "
68070|NCT02394756|"     The objective of this study is to assess how various silicone hydrogel lenses perform when     worn by subjects who are heavy digital device users.   "
68071|NCT02394743|"     Vascular inflammation is a key factor in both the pathogenesis and outcome of     atherosclerosis. Renal insufficiency is close correlation with atherosclerosis and     cardiovascular mortality.      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for     identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,     the purpose of the study is to demonstrate the correlation between eGFR and vascular     inflammation detected by 18F FDG-PET.   "
68072|NCT02394730|"     ADVICE is a randomised, international, double-blind, placebo-controlled trial. The purpose of     the ADVICE study is to compare the safety and efficacy of vorapaxar in reducing d-dimer     expression and markers of cellular immune activation over a period of 12 weeks among people     with HIV infection who are successfully treated with combination antiretroviral therapy     containing an HIV integrase inhibitor. A secondary objective of the study will be to     demonstrate that following cessation of vorapaxar in patients with well controlled HIV     replication there will be an increase in the levels of d-dimer over a 6 week period. 60     participants from 4 clinical sites in Australia and the USA will be recruited and followed     for a minimum of 18 weeks.   "
68073|NCT02394717|"     The investigators long term-goal is to help YMCA programs across the nation successfully     acheive the Y of USA Healthy Eating and Physical Activity Standards. Our objective here is     threefold. First, the investigators will work with South Carolina YMCA leadership to achieve     the Healthy Eating and Physical Activity Standards and implement our HEPA Strategies in     YMCA programs across the state, evaluate the uptake of and adherence to the standards and     strategies, and identify factors that influence their implementation. Second, the     investigators will evaluate the impact of acheiving the standards on children's MVPA and the     serving and consumption of FV and water during the programs. Third, the investigators will     evaluate the costs associated with and the cost-effectiveness of meeting the standards in     terms of improvements in activity and healthy eating.   "
68074|NCT02394704|"     Intrusive negative thinking styles such as rumination are typical of many psychiatric     disorders, are difficult to treat, and predict poor treatment outcome. The investigators     propose to evaluate a new intervention for negative thinking that capitalizes and builds on     the preserved ability to attend to physical sensation. The investigators will examine changes     in physiological mechanisms and symptoms.   "
68075|NCT02394691|"     In this study, researchers will show to caregivers of patients how to use a tDCS device (this     device was designed to be easy to use, with fixed parameters and only one button to press to     run the stimulation). They will be asked to apply a stimulation every day, 5 days per week     during for 4 weeks, in chronic patients in minimally conscious state (MCS).      2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a     randomized order. Before and after each session, behavioral improvement will be assessed with     the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the     end of the sessions to assess the long term effect of tDCS.   "
68126|NCT02394028|"     This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the     safety and efficacy of etrolizumab during induction and maintenance treatment of moderate to     severely active Crohn's disease (CD) in patients who are anti-tumor necrosis factor (TNF)     naive (TNF-naive) and in patients who are refractory or intolerant of tumor necrosis factor     inhibitors.   "
68076|NCT02394678|"     Intraventricular haemorrhage (IVH) - bleeding into the normal fluid spaces (ventricles)     within the brain - is associated with a high risk of death or significant long-term     disability. IVH leads to an increase pressure within the head and triggers inflammation and     swelling in the surrounding brain. The ideal treatment for IVH would both rapidly relieve     pressure and safely remove as much blood as possible to prevent any further injury to the     brain. Currently, patients are managed by inserting a tube into the ventricle that drains     fluid to the outside and helps reduce pressure, but does not address the blood clot itself,     which naturally dissolves only over several days or weeks.      Furthermore, these drains frequently block because of blood clots that for within them. If     that occurs a repeat operation is required to replace them. Experimental treatments include     infusing drugs to accelerate clot breakdown but this can nonetheless still take a number of     days and the process introduces a risk of infection and fresh bleeding. Surgery to remove the     blood clot is hazardous, technically challenging, and generally not very successful.     Therefore, at the present time, none of the available options achieve all the stated goals of     IVH treatment and there is an unmet need for better interventions.      In this study the investigators propose to pilot a novel instrument that employs a high     pressure but very localised microjet of water to mechanically disrupt blood clots and then     sucks the debris away. This technique has been highly successful in reopening blocked     arteries in the heart and, importantly, does so without damaging the underlying vessel     lining. In the context of IVH, this should allow rapid removal of blood from the ventricles     while causing minimal trauma to the brain. Clearing the blood early will prevent the build-up     of pressure and inflammation, and improve the chances of patients making a good recovery.   "
68077|NCT02394665|"     In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although     clinical gains have been achieved in the past, these have been modest, with a majority of     patients succumbing to local disease progression within 2 years. New strategies for treatment     need to be identified which enhance local control above the current treatment regimen in     order to achieve further clinical gains in this disease. Favorable early experience with     magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic imaging can     identify active tumor beyond standard MRI as well as high risk regions at risk for local     failure. There is also clinical evidence that limited field dose escalation with either     simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible and safe.     Coupling these findings provide the rationale for this proposed Phase II trial designed to     define efficacy and toxicity of the novel treatment approach of whole brain volumetric 3D     MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM patients.   "
68078|NCT02394652|"     Cervical cancer remains an important health problem worldwide. Poor tumor oxygenation     (hypoxia) is associated with inferior survival in cervical cancer and resistance to radiation     treatment. Hypoxia-modifying therapies improve survival, but existing therapies are     impractical and/or toxic. Metformin, a non-toxic drug for diabetes, has been shown to     decrease tumor hypoxia in animal studies and its use is associated with better survival in     diabetic cancer patients. It is hypothesized that metformin may decrease cervical tumor     hypoxia and thereby improve tumor response to radiation and survival in patients with locally     advanced cervix cancer.      This is a randomized, multicenter phase II study of standard chemoradiation in combination     with metformin versus standard chemoradiation alone in women with locally advanced cervix     cancer. Women randomized to the metformin group will take metformin starting 1 week prior to     standard chemoradiation and throughout the duration of external radiation treatment. Tumor     hypoxia will be measured by a special X-ray test called positron emission test (PET)     performed with a hypoxia dye called FAZA. The main purpose of this study is to see if     metformin decreases tumor hypoxia measured on FAZA-PET; information about response and side     effects will also be collected.   "
68079|NCT02394639|"     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with     user-friendly active dry electrodes that meets the expectations of the users regarding     comfort and esthetics, without losing sight of the functional and technical demands for     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that     hospital admission in the EMU can be avoided for some patients and an increasing number of     patients can be examined.      In this stage of the project video-EEG recording with the prototype will be compared to the     conventional way (cup-electrodes and collodion) of recording in the EMU.      Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional     recording is completed, the patient will undergo a recording of maximum 5 hours with the     prototype.      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical     evaluation of the EEG-signals. User experience and experience of the EEG-technologists will     also be collected.   "
68080|NCT02394626|"     Patients with glioblastoma face a grim prognosis. Despite recent advancement in neurosurgical     technology and neuro-oncology glioblastomas almost invariably progress or recur after a     median of 4-8 months. The strategy to repeat tumor resection at recurrence in order to     minimize tumor load and thus to facilitate subsequent second-line therapy has been shown to     be feasible and safe.      However, evidence for a survival benefit of surgery for recurrent glioblastoma is scarce and     relies entirely on retrospective analyses. While most retrospective analyses report an     apparent survival benefit, an EORTC meta-analysis on second-line therapies found no survival     difference in patients with or without surgery at recurrence. With regard to the risks and     costs inherent to surgery for glioblastoma, a randomized controlled trial is required.      The purpose of the study is to compare the effect of craniotomy and tumor resection followed     by adjuvant second-line therapy to no surgery followed by second-line therapy on overall     survival, neurological status, and quality of life. Analysis of overall survival will be used     to improve sample size estimation of a subsequent phase III trial for craniotomy and tumor     resection of glioblastoma recurrence in cooperation with the EORTC.   "
68091|NCT02394483|"     Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty     subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8     subjects. Each subject will be on study for approximately 6 weeks. Each subject will     participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from     Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in a     leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on     the first dosing day, and the last 6 will receive study drug (5 active and 1 placebo) on the     second dosing day.      All subjects will return for a post-study visit 8 to 10 days after the dose of study     medication.      Cohorts will be dosed at 2 weekly intervals. There will be a review of safety data, after the     first two subjects have been dosed and before dosing of the subsequent six subjects. There     will be a complete review of safety and pharmacokinetic data of each cohort prior to each     dose escalation.   "
68081|NCT02394613|"     Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell     (RGC) death. This is currently identified only after significant vision loss has already     occurred with an early event in, and a potential marker of, this process being RGC     apoptosis (a form of cell death).      This study aims to investigate the tolerability and safety of ANX776, as part of the new     Detection of Apoptosing Retinal Cells (DARC) technique. This has been developed by the     laboratory of DARC IP holder and grant applicant: Prof. M. Francesca Cordeiro. A secondary     aim is to initially establish the ability of DARC to identify RGC apoptosis in the diagnosis     of glaucoma in healthy and progressive glaucoma/glaucoma-suspect/ocular hypertensive     patients. As a positive control for this secondary aim of this study, patients with     Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) will be recruited.      During the study, each patient will undergo several ophthalmological examinations, imaging of     the back of the eye using established clinical devices, and blood sampling for studying the     safety and toxicology profile of ANX776.      The understanding of the safety profile of ANX776 is crucial for the use of DARC in patients,     and its application as a potentially powerful new clinical tool with which to identify     patients with early glaucoma before their vision is lost. If successful, it opens the door to     directly observing effects of glaucoma treatments, including the assessment of new,     breakthrough therapies.   "
68082|NCT02394600|"     This pilot study is a Phase IV, single center, placebo-controlled, parallel study design     conducted using the Environmental Exposure Unit (EEU). The study will aim to be determine     whether there are any benefits from Grastek® for the treatment of birch-pollen induced     allergic rhinoconjunctivitis. Grastek® is a Health Canada and FDA approved sublingual     immunotherapy (SLIT) for the treatment of grass-pollen induced allergic rhinoconjunctivitis.     The EEU provides a closed environment in which participants are exposed to a predetermined,     controlled, constant level of airborne pollen. 96 participants will complete this study and     will either receive Grastek® or placebo in a 1:1 ratio. The study will consist of a screening     visit, a pre-treatment pollen exposure visit, 60 days of treatment with Grastek® or placebo,     two treatment visits and a follow-up pollen exposure visit.   "
68083|NCT02394587|"     Significance: The purpose of this exploratory study is to test the feasibility,     accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on reducing     pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain. One of the     most difficult symptoms for SCD patients to manage is chronic pain. Approximately one-third     of SCD patients experience chronic pain, which is associated with pain catastrophizing. Pain     catastrophizing is a negative mental state toward pain stimuli and pain experience, and is     associated with increased pain severity, pain interference, and lower social functioning,     physical functioning, and mental health. There have been no psychobehavioral intervention     studies that have attempted to alter the experience of pain catastrophizing in persons with     SCD. MBSR is a complementary group-based therapy that emphasizes nonjudgmental awareness of     thoughts, feelings, and bodily sensations. With no pharmacological or non-pharmacological     treatment for catastrophizing in persons with SCD, MBSR offers a potential solution to this     highly significant problem for both SCD patients and providers. This project will be the     first randomized controlled trial (RCT) of MBSR to reduce pain catastrophizing, and improve     quality of life for SCD patients with chronic pain.      Methods: This study will enroll 60 adult patients with SCD and chronic pain from the Duke     Adult Sickle Cell Clinic. Patients will be randomized to a MBSR or wait-listed control group.     The MBSR group will complete a 6- week, group-based telephonic MBSR program that is     administered by a certified MBSR clinician once a week for 90 minutes. MBSR feasibility,     acceptability, and effects on pain catastrophizing will be assessed by questionnaires at     baseline, week 1, 3, and 6 in both groups. At the end of week 6, 10 randomly selected MBSR     participants will complete semi-scripted telephone interviews to help assess intervention     acceptability, and the wait-listed control condition will be offered the same MBSR     intervention.   "
68084|NCT02394574|"     Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an     estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life years     (DALY) every year in developing countries.52-54 Of all environmental risks, such as unsafe     water, poor sanitation, climate change and lead exposure, HAP accounts for the most mortality     and DALY.55 Despite the magnitude of the problems associated with HAP, research on its health     effects has been hindered by lack of accurate data on exposure and health outcomes. There are     few studies available that report HAP exposures and development of adverse pregnancy outcomes     from households using biomass fuels.   "
68085|NCT02394561|"     A study to evaluate the differences in the efficacy and safety of secukinumab between     Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis   "
68086|NCT02394548|"     This research study is examining the benefit of a novel radiation planning approach on the     likelihood of developing severe esophagitis (irritation and inflammation of the esophagus)     during the course of radiation therapy with concurrent chemotherapy which is associated with     very painful and difficult swallowing.   "
68087|NCT02394535|"     The goal of this clinical research study is to find the highest tolerable dose of Abraxane™     (nab-paclitaxel) that can be given in combination with capecitabine and radiation therapy to     patients with pancreatic cancer. The safety of this drug and drug combination will also be     studied.   "
68088|NCT02394522|"     The primary objective of the study is to demonstrate and quantify the protective efficacy     (PE) of spatial repellent products in reducing the incidence of malaria infection in human     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between     intervention and control arms.   "
68089|NCT02394509|"     The purpose of this study is to determine the feasibility and efficacy of the home-based     cognitive self-management program HOBSCOTCH delivered at four New England medical centers.     It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be     delivered from a distance utilizing e-health tools for parts of the program.   "
68090|NCT02394496|"     Based on these results it can be envisioned that the majority of endocrine-responsive     post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy     (front-line, switching or extending) and/or as first-line management of metastatic breast     cancer.   "
68092|NCT02394470|"     The purpose of this study is to validate non-invasive and user-friendly methods to monitor     systemic and pulmonary congestion in heart failure patients.      The primary objective is to validate the role of bioimpedentiometry, pulmonary and     subcutaneous ultrasound, to assess changes in total body water in patients with heart     failure. vs the gold standard technique of deuterium oxide dilution Secondary objectives are      - to evaluate the applicability of bioimpedentiometry, pulmonary and subcutaneous ultrasound     to monitor systemic, pulmonary and peripheral district congestion in relation with clinical     and laboratory variables; 2)to analyze the organizational issues related to the use of these     methods.   "
68127|NCT02394015|"     Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal     Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian     Cancer (ROC), According to SmPC.   "
68093|NCT02394457|"     PDPH is a common problem after either intentional or unintentional Dural puncture. It is     especially common in young female patients and in patients undergoing Lumbar Puncture using     the typical kit containing large 20 gauge needles (1).      Hypothesis is that Cosyntropin therapy is at least as effective as current conservative     therapy (caffeine/fluid) and/or Epidural Blood Patch.      Patients will be randomly assigned to undergo either: (1) EBP with IVF therapy or     (2)Cosyntropin IV with IVF therapy. Endpoints will be a pain score that is given prior to the     procedure, Emergency Department (ED) discharge pain score and post procedural day (PPD) day     1, day 3 and day 7 pain and functional levels. Patients in Cosyntropin arm of the study may     request crossover to EBP at anytime after a 24 hour assessment period is completed per     Standard of Care for treatment of PDPH, in order to ensure no undue distress is placed on the     patient in order to complete this study.      Current treatments consist primarily of non-invasive treatment with intravenous fluids and     caffeine therapy and invasive treatment by Epidural Blood Patch. Efficacy of Caffeine 300mg     IV bis in die (BID) x 1d doses is approximately 70% (2). However this therapy has been linked     to post-treatment seizures. EBP was originally thought to be 90% effective with repeat     treatment efficacy approaching >96%. However more recent studies by Taivainen et al (3) have     shown only a 61% rate of permanent cure. Additionally, EBP are contraindicated in patients     with signs of increased intra-cranial pressure (ICP), coagulation issues, signs/symptoms of     Central Nervous System (CNS) /systemic infection or local infection at the site of the EBP,     thus resulting in decreased utility. Complications are also quite serious ranging from     meningitis, spinal hematoma, repeat dural puncture, localized infection and vagal response to     the procedure. EBP are not typically performed until after conservative measures have failed     which leads to further prolongation of the patients decreased functional status and pain.     Additionally, the cost of both treatments is substantial considering prolonged ED visits for     conservative treatments often followed by the time and expense of an EBP.      The goal of this investigation is to aid in the confirmation of case reports advocating the     economy, efficacy and safety of synthetic Adrenal CorticTropin Hormone (ACTH) as a treatment     of PDPH (4,5,6,7,8,9).   "
68094|NCT02394444|"     The aim of this study was to assess the impact of an early psychological intervention,     Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental     health, and preterm infant development in the motor, cognitive, emotional and behavioral     domains at a corrected age of 18 months.   "
68130|NCT02393976|"     Compare the results in terms of morbidity, mortality and hospitalization among patients with     input from immunonutrients and patients with enteral nutrition intake of high calorie and     high protein undergoing colorectal surgery within a multimodal rehabilitation program.   "
68095|NCT02394431|"     Sickle Cell Disease is a serious disease that is life-threatening for patients being     homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann     hospital currently regularly treats about 70 homozygous adult patients and this number is in     constant augmentation.      Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the     haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages.      The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected     left ventricular fraction measured by echocardiography, this parameter being very dependent     of the blood volume.It has already been shown that the left ventricular ejection fraction was     normal in most patients with sickle cell disease, but that its evaluation by parameters     independent from the blood volume showed the existence of a dysfunction.      Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the     cardiac function, independent of the blood volume. This technique hasn't been used much in     sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle     cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a     higher global longitudinal strain in this patient population. The investigators find these     data hard to explain and in contradiction with previous studies using other cardiac function     evaluation techniques, independent from the blood volume.      The primary goal of this study is thus        -  to study the longitudinal strain by 2D echography        -  to determine if anomalies of the longitudinal strain exist in sickle cell disease          patients with a normal ejected left ventricular fraction, compared to a control group of          healthy patients.      The secondary goal of this study is to correlate, inside the sickle cell disease group, the     possible strain anomalies with biological gravity parameters of the disease.   "
68096|NCT02394418|"     Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical     course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using     CAM-ICU scale, GSK-3beta and protein S100b in serum.   "
68097|NCT02394405|"     Assessment of the severity of oxidative stress caused by the on-pump and off-pump CAGB using     mtDNA, nDNA, carbonilated proteins, nitrotyrosine, oxy-LDL, S100b-protein.   "
68098|NCT02394392|"     1. Investigate the clinical characteristics, medication satisfaction and quality of life of          anti-hypertensive drugs in Korean hypertensive patients        2. Observe the changes of medication satisfaction and compliance in patients after          switchting to Fimasartan   "
68099|NCT02394379|"     To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL     following cataract surgery.   "
68100|NCT02394366|"     Delayed wound healing leads to increased risk for infection, and thus increased risk for     morbidity and mortality. Skin oxygen delivery and peripheral blood flow predict wound     healing. The investigators will conduct a double-masked, placebo-controlled cross-over     clinical pilot trial in order to evaluate the effects of a topical, homeopathic/herbal salve     (Original Healing Salve, Puremedy, Inc.) on skin oxygenation and peripheral blood flow.   "
68101|NCT02394353|"     Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs     gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by     the transient elastography in the first year. Methods: This is a randomized clinical trial     with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of     Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB     (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml     pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated     gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube with     a bougie number 32 (70 ml). The variables were compared one week before surgery and in the     postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry,     laboratory tests and the transient liver elastography.   "
68102|NCT02394340|"     This is an open-label, maximal use study evaluating the drug interaction potential of     luliconazole cream 1% in subjects with tinea pedis and tinea cruris   "
68103|NCT02394327|"     Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis,     but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route     can be required to alleviate inflammatory process and reach an appropriate time for elective     surgery in patients with high operative risk or marked local inflammation or organ     dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often     needed because common bile duct (CBD) stone is accompanied in patients with acute     cholecystitis at reported rate from 7-20%.      Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice     versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone     who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB     through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or     plastic stent has alternatively been attempted in patients who have contraindications for     PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its     relatively low technical success rate and specific concern about post-ERCP adverse event but     it minimizes catheter keeping duration, and provides effective clinical improvement via     physiologic route.      Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are     comparable in terms of clinical efficacy and safety.   "
68107|NCT02394275|"     The primary goal of this proposal is to study the outcome of patients with recurrent     Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation     (FMT) in an open-labelled controlled trial. The specific objectives are to evaluate the     safety of FMT and to determine the clinical response, treatment failure and relapse rate in     patients treated with frozen-and-thawed FMT; to assess the functional health and well-being     of patients in each arm using the validated tool, and to determine the feasibility of     providing standardized FMT in multiple centres across Canada, including community hospitals.     The metagenomics will also be conducted from the stool samples collected from select patients     from each arm: pre and post treatment and the matching donors. The metagenomics data will be     used to determine the bacteria which may have contributed to the cure of CDI.   "
68108|NCT02394262|"     Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive     diagnostic imaging modality in patients with stable chest pain. Besides conventional     CT-reading, CCTA is also capable to identify several morphologic and geometric     characteristics of atherosclerotic plaques. Recently, the investigators showed that the use     of semi-automated plaque quantification algorithm identified parameters predictive for acute     coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition,     several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as     related to coronary artery disease and cardiovascular events. Prospective data with     sequential analysis of atherosclerotic plaques combined with different atherothrombosis     biomarkers are currently lacking, but will provide important clues about the pathophysiology     of plaque progression and atherothrombosis.   "
68109|NCT02394249|"     Background of the study:      A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major     focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical     activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical     activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be     spent. Several recent epidemiologic studies suggest that excessive sitting, independent of     moderate to vigorous physical activity, has detrimental health effects. Another possibility     to sit less is by increasing low intensity physical activities as slowly walking and     standing. A recent published study of Duvivier and colleagues suggests that sitting less and     replacing it by slowly walking and standing has a better effect on insulin action and     cardiovascular risk factors than the combination of one hour MVPA per day and sitting the     rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research     is not performed in subjects with overweight/obesity.      Objective of the study:      To assess the effect of low intensity physical activity on plasma insulin levels, cognition     and mood in subjects with overweight/obesity      Study population:      21 subjects between 40-80 years old with overweight/obesity      Intervention:      2 activity regimes of 4 days: a sitting regime and a sit less regime   "
68110|NCT02394236|"     Thus, the purpose of the present study was to evaluate the effects of continuos exercise     training (CET) and interval exercise trainining (IET) on oxygen uptake efficiency slope     (OUES) in patients with coronary artery disease.   "
68111|NCT02394223|"     Primary objective :      The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection     in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.      Secondary objective:        -  Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores        -  Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores        -  Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy          cores        -  Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores        -  Evaluate FFOCT procedure time   "
68112|NCT02394210|"     Post-authorisation prospective follow-up study to assess the clinical impact on time to     progression (TTP) from the start of anti- multiple myeloma treatment at the onset of     asymptomatic relapse/biological progression versus start of treatment at the time of     symptomatic relapse.   "
68113|NCT02394197|"     In the context of malaria elimination in the Americas, solid evidence is necessary of the     effectiveness of anti-malarial control measures delivered to the affected individuals. In the     Americas, most P. vivax infections are sensitive to Chloroquine (CQ) and Primaquine (PQ), and     the most effective treatment worldwide comprises administration of a total dose of 25     milligrams (mg)/Kilogram (kg) weight of CQ distributed in three days and 3.5 mg/kg body     weight of PQ administered during 14 days (T14). In Mexico, CQ and PQ have been administered     since the late 50´s to treat malarious patients. In 1999 the National Malaria Control Program     implemented an intermittent single doses treatment (ISD) as part of the overall strategy.     After the blood sample was obtained for diagnosis of symptomatic patients, a single combined     dose of CQ and PQ was administered, and after malaria infection confirmation, additional     doses were administered monthly alternating each three months, during 3 years. Although, the     number of malaria cases were reduced in most affected regions, in Southern México, many     patients under ISD present recurrent blood infections, presumably relapse episodes were     observed.      Working hypothesis: the administration of ISD is low effective to eliminate relapse episodes     and its effectiveness depends on the coincidence of the relapse episodes and the     administration of the medication), while the T14 is highly effective to eliminate P. vivax     primary and relapse infections.      Objective: To determine the antimalarial drug effectiveness of the ISD and T14, based on CQ     and PQ for the treatment of uncomplicated P. vivax infection (primary and recurrent blood     infections) in Southern Mexico.      Methods: The study was carried out in malaria affected communities of Southern Mexico,     following the WHO recommendations for clinical studies. Symptomatic patients diagnosed with     P. vivax infection that meet the inclusion criteria, were invited to participate. After they     accepted by informed consent, patients were semi-randomized and treated with either T14     (14-day treatment) or ISD (18 intermittent single doses of CQ-PQ). Clinical, parasitological,     molecular and serological parameters were monitor over a 12-month follow up period to     evaluate the treatment outcomes to cure blood infection and relapsing episodes. The study was     conducted from February-2007 to October-2010. The results of this study will be used to     assist the Ministry of Health of México in assessing the current national treatment     guidelines for uncomplicated P. vivax malaria   "
68114|NCT02394184|"     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve     replacement (TAVR) in patients with bicuspid aortic valve stenosis.   "
68115|NCT02394171|"     Health Is Power (HIP) was a community based health intervention designed to increase physical     activity among women of color. It was funded by a grant from the National Cancer Institute of     the National Institutes of Health. The purposes of the study were (1) to determine whether a     6 month, group cohesion intervention is more effective for increasing physical activity     compared to a 6 month, group cohesion comparison targeting improving dietary habits (2) to     determine whether residence in a neighborhood supportive for physical activity helped women     maintain their physical activity from 6 to , and (3) to determine whether this effect was     transculturally replicable.   "
68116|NCT02394158|"     Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent     gestational diabetes mellitus recurring in previously affected pregnancies.   "
68118|NCT02394132|"     The purpose of this study is to investigate the effectiveness of using either radiotherapy     (RT) or Imiquimod (ImiQ) to treat the Lentigo Maligna (LM), when surgery is not possible, is     refused, or fails.      Surgery is the standard treatment for people diagnosed with LM. However for some people, it     may not be possible due to the location of their LM lesion(s).      Currently, the Australian and New Zealand Melanoma Treatment Guidelines recommend     radiotherapy for the treatment of LM however there is no clinical trial evidence for this and     a trial is needed to prove which treatment is safer and more effective. Some clinicians may     also recommend the use of a cream called Imiquimod. It is approved and widely used in     Australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts,     and perianal warts. Although not currently licensed for treatment use in LM, there is some     evidence to suggest that it is both safe and effective in treating LM.      This trial will scientifically evaluate and compare these two treatments in a controlled     clinical setting.   "
68131|NCT02393963|"     This is a randomized, double blinded, controlled trial in patients undergoing elective Total     Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive     intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline     placebo.   "
68132|NCT02393950|"     The study is a dose escalation study with 8 planned dose levels. The study is a 4-period     crossover design where each healthy volunteer will be randomised to receive three dose levels     of ODM-106 (single doses) and one dose of placebo. The study will look at the     pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects     the body) of ODM-106.   "
68133|NCT02393937|"     The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the     treatment of Rosacea.   "
68119|NCT02394119|"     Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority of     Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease     remission in SD-INS.      Eligible participants will enter a 1-month run-in period, during which instruction on urine     collection and dipstick readings will be carefully reviewed, compliance assessed, and therapy     with RAS inhibitors withdrawn and, in hypertensive children replaced by other     anti-hypertensive drug.      After run-in period, children will be randomized to either the intervention arm (Ofatumumab)     or the comparator arm (Rituximab).      After infusion of intervention or comparator, steroids will be maintained at initial dose for     30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.      One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and     withdrawn within 2 additional weeks.      All patients will be followed for up to 24 months. In case of relapses during the study (see     outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in     order to achieve remission. At remission, patients will be treated with another infusion of     either Oftumumab or Rituximab, according to the initial randomization.      After infusion of intervention or comparator, steroids will be maintained at initial dose for     30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.      One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and     withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses     during the study.   "
68120|NCT02394106|"     Double-blind, two-parallel-arm, placebo-controlled randomized clinical trial testing the     superiority of Ofatumumab versus placebo in the treatment of children with DR-INS.     Participants will be stratified according to eGFR at enrollment.      Eligible participants will enter a 3-months run-in period, during which instructions on urine     collection and dipstick readings will be carefully reviewed, compliance assessed and any     immunosuppressive therapies withdrawn according to the following schemes:        -  prednisone will be tapered off by 0.3 mg/kg per week until complete withdrawal;        -  calcineurin inhibitors and mofetile mycophenolate will be decreased by 50% and withdrawn          after 2 additional weeks In order to minimize the risk of complications of uncontrolled          INS a treatment with ACE-inhibitor at 6 mg/m2 will be maintained or started in all          patients.      After run-in period, children will be randomized to the intervention arm (Ofatumumab) or     comparator arm (placebo). Randomization will be stratified by eGFR at randomization: ≥90 and     <90 ml/min/1.73 m2.      All patients will be followed up to 12 months and they will leave the study at time of     relapse.      Relapse will be defined as uPCR ≥2000 mg/g (≥200 mg/mmol) or ≥ 3+ protein on urine dipstick     for 3 consecutive days.   "
68121|NCT02394093|"     To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing     dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin     tablets and aspirin effervescent tablets in healthy adults.   "
68122|NCT02394080|"     The purpose of this study is to collect safety and performance data on the use of the     Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and     alignment for the treatment of acute humerus fractures.   "
68123|NCT02394067|"     This prospective study will use magnetic resonance imaging of patients with Idiopathic     Intracranial Hypertension (IIH), to determine if the common radiological finding of     transverse venous sinus stenosis can be reversed with standard of care medical treatment of     IIH.   "
68124|NCT02394054|"     It has long been established that interpersonal relationships can have a profound impact on     health and well-being. Yet, the investigators are still learning about the complex biological     processes that contribute to positive social interactions and the ability to develop and     maintain social relationships. Recent research has begun to focus on vasopressin, a     neuropeptide that is naturally produced in the hypothalamus, because administration of this     neuropeptide has been associated with empathy, cooperation, memory of social stimuli (e.g.,     faces), and brain activity in neural regions associated with social and emotional processes.     To date, several aspects of vasopressin's effects on social behavior have been unexplored. As     such, the overarching goal of this project is to examine the effects of intranasal     vasopressin on several tasks involving learning and social processes. In addition, the     investigators will explore associated neural activity through functional magnetic resonance     imaging (fMRI). Results from the study will inform our understanding of the neurobiology of     socioemotional processes.      The investigators hypothesize that compared to placebo, vasopressin will improve deception     detection, increase empathy and altruism, enhance responses to photo stimuli of primary     caregivers, and improve learning when the subject has a prosocial goal of teaching another     person. These effects will manifest in behavioral and neural activity. It is also     hypothesized that main effects will not be found for vasopressin, but rather, analyses of     relevant moderators will elucidate these findings.   "
68125|NCT02394041|"     The principal objective of the trial is to demonstrate that acupuncture could reduce the     caesarean section rate for cervical dystocia.      Secondary objectives:      To demonstrate that acupuncture can:        -  reduce morbidity, fetal mortality and duration of childbirth;        -  reduce the cost of care, due to diminution of caesarean sections and duration of          obstetric labor;        -  to evaluate the tolerance.   "
68403|NCT02390414|"     The purpose of this observational study is to compare overall survival in older adults with     myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic stem     cell transplant (RIC HSCT) versus those who do not receive HSCT.   "
68128|NCT02394002|"     The relation between burst and suppression periods in transcranial and direct cortical     recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is     studied.      60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine     surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures     (Helios Klinikum Wuppertal).   "
68129|NCT02393989|"     Background: This 3-year clinical trial compared the performance and post-operative     sensitivity of a posterior resin composite with that of bonded-amalgam in large sized     cavities. Additionally, it was evaluated whether resin composite could be an alternative for     bonded amalgam.      Methods: This was a randomized clinical trial. Patients in need of at least two posterior     restorations were recruited. Authors randomly assigned one half of the restorations to     receive bonded-amalgam and the other half to composite restorations. Forty bonded-amalgams     and composites were evaluated for their performance on modified Ryge criteria and     post-operative sensitivity using VAS for 36-months.   "
68134|NCT02393924|"     This disease registry is a prospective, multicenter non-interventional study designed to     observe the different anticancer treatment regimens and their sequencing throughout the     course of the disease in participants with unresectable locally advanced breast cancer (LABC)     or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment     regimen measured as progression-free survival.   "
68135|NCT02393911|"     Currently, the pathogenesis of Localized Provoked Vulvodynia (LPV) has not been elucidated.     Few observations may point to involvement of the microbiome: the association of LPV with     preceding chronic recurrent candidiasis, and the reports of the beneficial effect of a diet     avoiding oxalate on Vulvodynia.      Studies in the new field of microbiome research focus on the composition of overall     microorganisms in our body and their impacts on our health. Changes in the composition of the     vaginal microbiota (dysbiosis) have been linked with different health and disease states. We     have also shown recently that women can be divided into 2 groups according to the composition     of their vaginal microbiome.      The proposed study will compare the vaginal microbiome of women with severe LPV, not treated     by diet and otherwise healthy, to women without LPV (we will also compare our results to the     NIH HMP data). Vaginal pH and date of menstrual cycle will be checked. We propose that     dysbiosis in the vaginal microbiota may trigger the development of LPV.   "
68136|NCT02393898|"     The purpose of this study is to evaluate the safety and efficacy in the frontline treatment     of ovarian cancer in participants 70 years of age and older in routine clinical practice in     Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by     bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).   "
68137|NCT02393885|"     The objective of this study is to establish the safety and effectiveness of a dual epicardial     and endocardial ablation procedure for patients presenting with Persistent Atrial     Fibrillation or Longstanding Persistent Atrial Fibrillation   "
68138|NCT02393872|"     The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based     intervention aiming to create a more supportive social and physical environment to promote     lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle     income countries and from vulnerable groups in high income countries in Europe.   "
68139|NCT02393859|"     B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according     to risk characteristics to ensure that appropriate treatment is administered to patients with     high-risk of relapse. In general, pediatric treatment regimens are more intense than those     employed in adults and include courses of combination chemotherapy. Standard of care     chemotherapy is associated with considerable toxicity. There is a lack of novel treatment     options for subjects who relapse or are refractory to treatment. Therefore, innovative     therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain     antibody construct designed to link B cells and T cells resulting in T cell activation and a     cytotoxic T cell response against CD19 expressing cells. This study will evaluate the     event-free survival (EFS) after treatment with blinatumomab when compared to standard of care     (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal     residual disease compared to SOC chemotherapy will also be investigated.   "
68140|NCT02393846|"     The aim of this study is to analyse the effect of ketoprofen gel in patients presented with     ankle sprain to the emergency department.   "
68141|NCT02393833|"     The serum protein research study is a substudy of the core study 'Maintenance Chemotherapy in     Hormone Non-responsive Breast Cancer'. This substudy is an evaluation of blood proteins and     their relationship to breast cancer treatment. It will assess the levels of Vascular     Endothelial Growth Factor (VEGF), Soluble HER2 Protein (NRP, neu-related protein) and     Vascular Cellular Adhesion Molecule-1 (VCAM-1) in serum samples of patients' blood at     different time points. The goal is to evaluate differences in serum levels between patients     receiving the maintenance chemotherapy and those who do not. The serum levels will be also     examined to determine if they vary during the three year period of evaluation. In addition,     the serum levels of patients who have a recurrence of their breast cancer will be compared     with those who remain disease free. The information obtained from these studies will enable     breast cancer physicians to better tailor therapies for future patients.   "
68142|NCT02393820|"     Open-label, multicenter, single arm phase II study, set up in collaboration with the REFCOR,     evaluating the activity and safety of single agent pazopanib in recurrent or metastatic     tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the     activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).   "
68143|NCT02393807|"     The current study will investigate the relative bioavailability of a spray dried dispersion     solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF     06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a     nanosuspension under fasted or fed conditions in healthy adult subjects.   "
68144|NCT02393794|"     Study combination use of cisplatin plus romidepsin and nivolumab in metastatic triple     negative breast cancer (TNBC) or BRCA mutation-associated locally recurrent or metastatic     breast cancer   "
68145|NCT02393781|"     The aim of this prospective study is to assess the prognostic value of bioactive plasma     adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international     multicenter study and to validate the findings concerning the association of ADM     concentration and the use of vasopressor therapy, organ failure and outcome.   "
68146|NCT02393768|"     In this study, the investigators will determine whether patients with documented     atherosclerosis are characterized by specific epigenetic changes in circulating cells of the     innate immune system, compared to patients without atherosclerosis.   "
68147|NCT02393755|"     This phase I/II trial studies the side effects and best dose of nintedanib when given     together with capecitabine and to see how well they work in treating patients with colorectal     cancer that has not responded to previous treatment (refractory) and has spread to other     places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. It may also block the growth of new blood vessels     necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine     may be a better treatment for colorectal cancer.   "
68148|NCT02393742|"     Nitric oxide (NO) is an essential molecule in the body that decreases with aging and causes     reductions in vascular, movement (motor) and cognitive functions. This study will determine     if daily oral supplementation (3 months) with a compound that increases NO in the body, i.e.,     sodium nitrite, improves vascular, motor and cognitive function in older adults. The project     also seeks to provide insight into the biological reasons (mechanisms) by which     supplementation with sodium nitrite improves physiological function in older adults. Overall,     this research will provide scientific evidence supporting the use of sodium nitrite for     preserving physiological function and preventing clinical disease and disability with aging.   "
68149|NCT02393729|"     All the studies underlined the high frequency of co-morbid associations in specific learning     disorders. Understanding the reasons for these associations could enable us to determine the     cerebral bases that underlie each disorder. Their frequent association suggests the     etiological bases are partly common, it seems logical to turn to explanatory models of     various common specific disorders. The model recently proposed by Nicholson & Fawcett (2007)     suggests a specific disorder of procedural learning. But the brain networks involved in this     learning could be achieved separately. We intend therefore to study the neural networks     involved in learning procedural and compare networks recruited among children with specific     learning disorder alone or in combination (co-morbidity). The children included in the study     have either a Developmental Dyslexia or a Developmental Coordination Disorder, or both. The     procedure includes a neuropsychological evaluation and a brain MRI study with a morphological     and a functional part. During fMRI the child realizes a automated motor task contrasting with     a task involving learning procedural.   "
68150|NCT02393716|"     The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is     safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac     aneurysms.   "
68151|NCT02393703|"     The purpose of this study is to isolate and analyze exosomes, which are tiny carriers of     important proteins and nucleic acids that serve as messenger systems in the blood and tissue.     Blood and tissue from patients with pancreatic cancer will be compared with blood and tissue     from patients with noncancerous pancreatic disease. Including patients without cancer will     allow the investigators to establish normal values, which currently do not exist. The     investigators will then look to see whether exosome activity has a connection to disease     recurrence and outcomes in patients. The results of this study will be the basis for future     studies exploring this area.   "
68152|NCT02393690|"     This randomized phase II trial studies how well iodine I-131works with or without selumetinib     in treating patients with thyroid cancer that has returned or has spread from where it     started to other places in the body. Many thyroid cancers absorb iodine. Because of this,     doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of     standard practice. It is thought that the more thyroid tumors are able to absorb radioactive     iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink.     Selumetinib may help radioactive iodine work better in patients whose tumors still absorb     radioactive iodine. It is not yet known whether iodine I-131 is more effective with or     without selumetinib in treating thyroid cancer.   "
68153|NCT02393677|"     80 American Society of Anesthesiologists (ASA) grade I-II patients, 18-60 years old,scheduled     for elective upper limb orthopaedic surgery under supraclavicular brachial plexus block, were     included in this prospective study. The patients were randomly assigned to group R     (Ropivacaine alone) and group RD (Ropivacaine and dexmedetomidine) (40 patients in each     group). Group R received Ropivacaine 0.50% (30 cc) + placebo and group RD received     Ropivacaine 0.50% (30 cc) + dexmedetomidine 1 µg/kg.   "
68180|NCT02393326|"     Objective: To compare success rates of biodentine partial pulpotomy versus formocresol     pulpotomy treatment of pulpally exposed lower primary molars.      After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated     to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained,     an assistant drew lots to randomly allocate the case to either the biodentine partial     pulpotomy (PP) or the formocresol pulpotomy (FP) group.      The follow-up for clinical and radiographic evaluation will be carried out at 6-month     intervals.   "
68154|NCT02393664|"     Lung cancer is the leading cause of cancer death in Taiwan and worldwide. With the     advancement of thoracoscopic technique, thoracoscopic surgery has emerged as a reasonable     option for the management of early-stage non-small cell lung cancer (NSCLC). Additionally,     current lung cancer screening policy recruits increasing number of candidates requiring     thoracoscopic lung resections because of lung nodules/tumors. Traditionally, intubated     general anesthesia with one-lung ventilation using a double-lumen endotracheal tube or an     endobronchial blocker has been considered mandatory in thoracoscopic surgery. However,     adverse effects of intubated general anesthesia are not negligible. Recently, a nonintubated     thoracoscopic technique has developed to reduce the adverse effects of intubated general     anesthesia with encouraging results. Nonetheless, the role of nonintubated technique in     thoracoscopic lung resection surgery in quality of postoperative recovery in not clear. As an     enhanced recovery is the major goal of modern minimally invasive surgery, the investigators     hypothesize that nonintubated thoracoscopic technique can facilitate and improve the recovery     quality after surgery. To this end, the investigators will recruit 300 patients in subgroups     including patients undergoing segmentectomy/lobectomy, wedge resection and geriatric patients     in this two-year project. Patients will be randomly allocated in nonintubated and intubated     groups and quality of recovery of all patients will be evaluated according the protocol of     Postoperative Quality of Recovery Scale. In the meantime, the preoperative and postoperative     cytokines will be compared between the groups as well as patients with different recovery     scales.   "
68182|NCT02393300|"     Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid     (TXA) reduces blood loss and post-operative blood transfusion rate largely without major     complications . In addition, many meta-analyses have confirmed these results . However, there     is little information about comparison among the different routes of TXA administration in     TKA. Therefore, this study has been designed to determine which administration route of TXA     is more effective and safety.   "
68355|NCT02391038|"     The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian     participants with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or     Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl     Cyclase C (GCC).   "
68155|NCT02393651|"     Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have     limited effects on motor recovery. Therefore, investigating new potential therapeutic     approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of     non-invasive electrical stimulation where a weak current is applied through electrodes over     the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which     can last up to one day with late LTP-like plasticity protocols in a polarity and     site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several     pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke     patients, but it's still unclear how tDCS should be repeated over multiple days to optimally     enhance recovery and training effects. Using a late LTP-like plasticity protocol could     increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the     effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like     plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study     can provide important guidelines on effective motor therapy during stroke rehabilitation.      Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the     subacute phase after stroke.      Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute     stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper     limb motor function during the subacute phase after stroke.   "
68156|NCT02393638|"     This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical     simulator for training endoscopic sphincterotomy.   "
68157|NCT02393625|"     This is an open label multi center trial to determine the safety and efficacy of ceritinib in     combination with nivolumab in ALK-positive NSCLC patients   "
68158|NCT02393612|"     Sarpogrelate hydrochloride, a selective 5-HT2A antagonist, has been widely used as an     anti-platelet agent for the treatment of PAD. DP-R202 is a new Sarpogrelate hydrochloride     product improved patient's convenience and disadvantage of dosage regimen of previous drug.     The aim of this study was to compare the efficacy and safety of DP-R202 and Anplag® Tab in     patients with PAD   "
68159|NCT02393599|"     The primary objective of this study is to determine if there are significant interactions     between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine     infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate     (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).   "
68160|NCT02393586|"     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium     tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and     Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following     single doses of faropenem plus amoxicillin/clavulanic acid.   "
68161|NCT02393573|"     Major surgery results in a stress- induced catabolic response, marked by post-operative     insulin resistance, hyperglycemia and loss of body protein, which is associated with     increased morbidity, mortality and adverse outcomes. There has been a great deal of research     on different approaches to optimize post-operative insulin sensitivity including hormonal and     nutritional interventions, minimally invasive surgical techniques and epidural anesthesia.     However, the correlation between insulin resistance and body protein loss is not well     understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering     drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation     between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection     patients; 2) investigate whether the post-operative metabolic state can be improved by the     pre-operative administration of metformin; and assess the impact of metformin on surgical     complications and hospital length of stay. The results of this study will provide insight     into the relationship between insulin resistance and post-operative adverse events and     potentially suggest a novel approach to improve outcomes using Metformin, a drug already in     wide clinical use.   "
68162|NCT02393560|"     The purpose of this study is to determine presence and volume of monosodium urate (MSU)     crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout     subjects treated with allopurinol with and without visible tophi.   "
68163|NCT02393547|"     This will be an open label clinical trial with all subjects receiving both lorcaserin and     varenicline with a primary aim of reducing post cessation weight gain.   "
68181|NCT02393313|"     This study evaluates the Rayner T-flex Toric IOLs for spherical and astigmatic correction,     and rotational stability in cataract surgery. 50 patients with cataract and corneal     astigmatism >= 2 diopters will undergo cataract surgery, with implantation of Rayner toric     intraocular lens. Post-operative examination will include IOL axis measurements and     refraction.   "
68404|NCT02390401|"     To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean     section incisions in the obese compared with standard sterile dressing.   "
68164|NCT02393534|"     Doctors frequently speak with their patients over the telephone. Having a visit with a doctor     over the telephone rather than face-to-face can be convenient for patients and allow them to     save time and money on transportation and missed time from work. However, some patients may     prefer seeing the doctor in person. In this study, we will study two groups of patients -     some who have their visits with their doctor over the telephone and some who have them     face-to-face. Using surveys and interviews, we will study if the groups differ in their     satisfaction with their visit with their doctor after participating in the study for 6     months. We will also look at doctor satisfaction with telephone visits, use of clinic     resources and if patients received recommended care such as laboratory tests and vaccines     during the study period.   "
68165|NCT02393521|"     The aim of this study was to investigate the efficacy of a self-administered vibration     therapy treatment on neck pain, disability and pressure pain thresholds in patients with     non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized     that patients receiving vibration therapy would report less perceived neck pain, disability     and present higher PPTs after receiving vibration therapy when compared to a control     no-treatment group.   "
68225|NCT02392741|"     This study aims to determine the effect of a physical exercise program on microcirculation     and maternal and perinatal outcomes in obese women. A randomized clinical trial will be     performed at IMIP with obese pregnant women assisted at the Instituto de Medicina Integral     Professor Fernando Figueira (IMIP) prenatal service.   "
68166|NCT02393508|"     In this study, the investigators will be evaluating the impact of red blood cell age in     patients receiving chronic blood transfusions in the outpatient setting. This study will have     a double-bind, randomized trial design, meaning that the investigators and participants will     not be told the group assignment at study enrollment.      Study participants will be randomly divided into two groups (50% of participants in each     group) by a computer generated block randomization schema. The 'fresh blood' group will     receive blood units that are 7 or less from the time of donor collection, and the 'aged     blood' group will receive blood units that are greater than 21 to 42 days from the time of     donor collection. The number of units of blood transfused will be decided based on the     participant's hemoglobin level before blood transfusion.      The primary goal of our study is to compare annual red blood cell product use (the number of     units given per patient in a year). The investigators will also be comparing groups to     evaluate the transfusion reaction frequency, iron burden (based on the level of ferritin in     the blood), overall transfusion and care cost difference, and participant time spent in     outpatient departments.      Our hypothesis is that use of fresh blood in chronically transfused patients will lead to a     decrease the in red cell transfusion rate, with subsequent clinical benefits including     reduction of transfusion reaction frequency and systemic iron burden.      This study will be taking place within the Calgary Zone of Alberta Health Services only.   "
68167|NCT02393495|"     Different studies have been made in an attempt to reduce the pain and the duration of the     process of outpatient insertion of the intrauterine device. in this trial, the investigators     aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain,     decrease the process of insertion, in addition, it reduces the incidence of malposition of     IUD as well as the risk of complications.   "
68168|NCT02393482|"     The purpose of the study is to evaluate the impact on quality of life, psychological health,     sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with     endometriosis, through the administration of self reported questionnaires. Amenorrhea in the     first group is caused by balanced assumption of estroprogestins, in the second group is     caused by GnRHa-induced hypoestrogenism.   "
68169|NCT02393469|"     The Chronic Obstructive Pulmonary Disease (COPD) has shown a progressive increase of     morbidity and mortality, suggesting that the lung as a single therapeutic target, has not     contributed in the past 20 years, significant changes to the natural evolution of the     disease. Direct treatment for systemic changes and comorbidities, in fact, the most     responsible for high rates of treatment failure could mean a new hope of life for individuals     with COPD. This research project characterized as interdisciplinary and multidisciplinary     program will be headquartered in Pulmonary Rehabilitation of the Santa Cruz Hospital which     has partnerships with local companies . Its main objective will be to analyze     cardiorespiratory and functional capacity in COPD patients not rehabilitated and     rehabilitated after the period from 02 to 12 months of treatment in a Pulmonary     Rehabilitation program in the municipality of Santa Cruz do Sul - Rio Grande do Sul. Will be     included in this survey of COPD patients who were referred to a rehabilitation program with a     clinical diagnosis of disease. In research activities to assess cardiorespiratory and     functional capacity of COPD, pre and post-program (02 and 12 months) are provided for     Pulmonary Rehabilitation. The research subjects will also be subjected to physical exercise     protocol as recommended by the GOLD (2009), a period of eight weeks, often 2x / week, where     their vital signs are measured before, during and after each session. Thus, it is believed     that it will be possible to refine the knowledge of mechanisms by which the judicious use of     pulmonary rehabilitation can control the progression of COPD.   "
68170|NCT02393456|"     It has long been established that interpersonal relationships can have a profound impact on     health and well-being. Yet, the investigators are still learning about the complex biological     processes that contribute to positive social interactions and the ability to develop and     maintain social relationships. Recent research has begun to focus on oxytocin, a neuropeptide     that is naturally produced in the hypothalamus, because administration of this neuropeptide     has been associated with increased trust, generosity, empathy, cooperation, memory of social     stimuli (e.g., faces), and brain activity in neural regions associated with social and     emotional processes. To date, several aspects of oxytocin's effects on social behavior have     been unexplored. As such, the overarching goal of this project is to examine the effects of     intranasal oxytocin on several tasks involving social processes. In addition, the     investigators will explore associated neural activity through functional magnetic resonance     imaging (fMRI). Understanding how oxytocin influences these aspects of social functioning     will help to inform research that has begun to establish the potential for use of this     neuropeptide in education as well as psychiatric disorders such as autism spectrum disorders     and schizophrenia that are characterized by social deficits.      The investigators hypothesize that compared to placebo, oxytocin will improve deception     detection, increase empathy and altruism, and enhance responses to photo stimuli of primary     caregivers. These effects will manifest in behavioral and neural activity. It is also     hypothesized that main effects will not be found for oxytocin, but rather, analyses of     relevant moderators will elucidate these findings.   "
68183|NCT02393287|"     The objective of this observatory is to evaluate the effecacy of Eribulin in patients with     metastatic breast cancer on a recent prescription period.      Part of the data collection will be retrospective and the other part will be prospective for     patients started treatment by Eribulin between November 2014 and September 2015. It will     allow a better assessment on the safety profile of this drug.   "
68215|NCT02392871|"     The purpose of this study is to investigate the side effects and safety, and effectiveness of     combining dabrafenib and trametinib with radiotherapy.      Previous and ongoing clinical trials have demonstrated the effectiveness and safety of     combining both dabrafenib and trametinib compared with dabrafenib alone. This has led to the     approval for the use of both drugs in combination in people with metastatic melanoma with the     BRAF mutation. Melanoma that has spread to other parts of the body may also benefit from     radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that melanoma     may be sensitive to radiotherapy and that it can help to improve quality of life.      The intention of the CombiRT study is to establish if dabrafenib, trametinib and radiotherapy     combined is a safe and effective treatment for metastatic melanoma.   "
68171|NCT02393443|"     One well-established cognitive theory propose a divide between social and non-social (i.e.,     cognitive) systems. However, recent work suggests that traditionally social systems can be     utilized to enhance cognitive performance. In this study the investigators aim to explore     this cooperation between oft-competing systems by instructing participants to learn     information because they will be subsequently tested (the nonsocial learning-for-testing     condition), or because they will be teaching the information to someone else (the prosocial     learning-for-teaching condition). This latter condition relies upon the mentalizing system,     which is used to contemplate another person's mental state, rather than traditional memory     systems. This implies that the mnemonic powers of the mentalizing system can be leveraged in     the learning of a broad array of non-social topics. Furthermore, there is also an emerging     literature on the role of oxytocin, a neuropeptide naturally produced in the hypothalamus, in     memory that parallels the social/nonsocial split. Oxytocin may benefit the     learning-for-teaching group both in terms of enhancing initial social motivation and     efficient use of the mentalizing system and then also in terms of memory consolidation for     this information learning under socially-motivated conditions.      The investigators expect to replicate the basic learning-for-teaching effect such that those     in the teaching condition will remember more than those in the testing conditions. They also     expect an interaction between oxytocin administration and learning condition such that     oxytocin administration should enhance learning for socially-motivated learning exclusively.   "
68172|NCT02393430|"     To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with     chronic gastritis were randomly divided into the experimental group and the control group.     The experimental group were treated with rebamipide 0.1g tid and optimization of life style,     and the control group were only optimized their life style for 26 weeks. Upper     gastrointestinal endoscopy was performed in all patients to evaluate the severity of     gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before     and after treatment.   "
68173|NCT02393417|"     This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the     exception of unblinded dedicated staff to handle study medication), phase 2a study with 3     dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20     weeks (10 doses administered every other week) or until a subject has complete resolution of     all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local     tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length     of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for     evidence of new or reoccurring warts and for safety evaluation.   "
68174|NCT02393404|"     Objective: To compare the effectiveness of functional movement-power training (PT-FMT),     functional movement training (FMT) alone and no intervention in improving balance strategies     and performance among children with developmental coordination disorder (DCD).      Design: A randomised controlled clinical trial. Sample: 87 children with DCD. Interventions:     12 weeks of PT and FMT or FMT alone in the two intervention groups.      Major outcomes: Sensory organisation test - balance strategy and composite scores; Movement     Assessment Battery for Children - total impairment score and balance subscore; hand-held     dynamometer measurements of lower limb muscle strength and time to peak force.   "
68175|NCT02393391|"     Neuropathic pain results from damage to or dysfunction of the peripheral or central nervous     system, rather than stimulation of pain receptors. Diagnosis is suggested by pain out of     proportion to tissue injury, dysesthesia (eg, burning, tingling), and signs of nerve injury     detected during neurologic examination. Although neuropathic pain responds to opioids,     treatment is often with adjuvant drugs (eg, antidepressants, anticonvulsants, baclofen,     topical drugs). Neuropathic pain (e.g. phantom limb pain, CRPS, postherpetic neuralgia,     postsurgical pain syndromes, CLBP etc.) remains a challenging condition to treat because it     is commonly refractory to classical pharmacological and to surgical treatment approaches.     Chronic low back pain (CLBP) is a widespread and costly problem for which few interventions     are effective. An increased focus on the study of the nervous system and its involvement in     pain disorders has documented complex neuronal activity and structural changes at a     peripheral, as well as at spinal cord and cortical levels indicating a neuropathic element in     CLBP. Accumulated evidence suggests that neuropathic pain in general and CLBP specifically     might be associated to brain cortical plastic changes. Thus an ideal rehabilitative approach     should aim to reverse them. In line with this idea, the investigators suggest an innovative     noninvasive intervention aimed at alleviating neuropathic pain. New rehabilitative approaches     have been proposed to try and reverse this cortical reorganization. Results of several     studies have shown that motor cortex stimulation with epidural electrodes or repetitive     transcranial magnetic stimulation (rTMS) or transcranial direct stimulation (tDCS) are     effective in reducing pain in patients with central pain refractory to treatment.     Transcranial direct current stimulation (tDCS) is an easily applied and safe technique by     which brain activity can be modulated noninvasively and can decrease pain in patients with     refractory central pain. The investigators hypothesized that focal-tDCS treatment personally     customized to each patients basal neuronal network properties would result in both acute and     long term pain relief for neuropathic pain patients.   "
68176|NCT02393378|"     The purpose of this study is to evaluate the efficacy and safety of namilumab in combination     with existing methotrexate (MTX) over 24 weeks in patients with moderate to severe early     rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX     alone.   "
68177|NCT02393365|"     Hepatitis C is caused by the hepatitis C virus (HCV) that causes inflammation of the liver     that can lead to diminished liver function or liver failure.      The number of chronically infected persons worldwide is estimated to be about 170 million     that is 2.35% of the world population. Most people infected with the hepatitis C virus have     no symptoms of the disease until the advanced stages of liver disease have occurred, which     may take several years. The long-term impact of HCV infection is highly variable, from     minimal changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma     (HCC).      Advanced liver disease (ALD) can lead to significant clinical and economic consequences,     including liver transplantation. HCV can reduce life expectancy and impair quality of life.     HCV-related complications as well as the highly debilitating effects on patients represent a     significant item of expenditure for the National Health Service. Because of the latency of     infection, numerous country-specific population analyses suggest that HCV will cause an     increasing number of liver-related deaths despite the dramatic drop in incidence and     prevalence. These deaths will be related to prevalent HCV infection especially during and     after World War II through indiscreet and widespread treatment with intravenous injection     using contaminated syringes, needles and remunerated blood donors. Eradicating HCV infection     can prevent the complications of HCV-related liver and extrahepatic diseases, including liver     necroinflammation, fibrosis, cirrhosis, HCC, and death.      Newly discovered hepatitis C virus (HCV) therapy with direct acting antiviral agents (DAA)     like Simeprevir, sofosbuvir open a new chapter in the treatment of chronic hepatitis C. Those     new treatment regimens promise oral dosing, higher SVR, shorter duration of treatment and     fewer side effects. In a near future all patients should qualify for future all-oral     therapies.      However recent analysis have shown that increasing efficacy of treatment alone will not be     able to reduce the HCV disease burden. The largest reduction in HCV-related morbidity and     mortality can be obtained when higher efficacy therapies is combined with increased diagnosis     and treatment rate. With a treatment rate of 10% it is possible to achieve a > 90% decline in     total infections by 2030. This would require a 3-5 fold increase in diagnosis and/or     treatment for most countries.      The implementation of screening criteria for hepatitis C virus (HCV) such as targeting birth     cohorts has potential effect on reducing the progression of hepatitis C virus (HCV) to     advanced liver disease (ALD) and could avoid unnecessary high financial costs and preserve     quality of life.      Robust data from public health surveillance, surveys of the general and risk populations are     required to make decisions in allocating public health resources to diagnose, assess and     treat HCV infection.      In Belgium no recent prevalence studies have been conducted. The most cited anti-HCV     prevalence is 0.87% based on a study in the Flemish population published in 1997 but     collected in 1994. In a French Belgian population there was an overall seroprevalence of     0.6%. However, the population under study was not representative for the whole French     community, because the recruited subjects were significantly younger.      A survey among cirrhotic and hepatocellular patients in the French community revealed that     20% of cirrhosis and 47% of hepatocellular cancer were related to hepatitis C. The diagnosis     rate of HCV in Belgium is estimated at 43%, signifying that more than 50% of HCV patients     remains undiagnosed.      Several studies have already mentioned that aged population especially those born after     Second World War are carriers of hepatitis C virus infection. Early detection of HCV     infection and treating before progress to advanced liver disease (ALD) is an excellent     opportunity to rationalize resource allocation and to improve patients' quality of life.      Recently birth cohort screening recommendations were developed in the United States. In     Belgium, no formal screening strategy exists. However the Belgian association of the study of     the liver (BASL) recommends targeted HCV screening for high-risk populations (including     individuals with a blood transfusion or major medical event prior to 1 july 1990, intranasal     or IDU and dialysis patients) in addition to nontargeted screening among pre-operative     patients and pregnant women. A birth cohort analysis based on a model suggests a birth cohort     between 1950 and 1975 in Belgium. This population should reflect 70% of the viremic     population.      In this study, the investigators want to estimate the prevalence of hepatitis C in Belgium in     2014 and to confirm the proposed targeted birth cohort and other risk factors. These data     could provide an efficient source of identifying newly diagnosed patients as part of a     national screening strategy.   "
68178|NCT02393352|"     This study evaluates the benefits of dry needling in trigger points on autonomic nervous     system, photoelectric plethysmography, body composition in patients with fibromyalgia     syndrome.   "
68179|NCT02393339|"     The aim of the study is to compare the efficacy of the pre-operative administration of     Paracetamol and placebo in reducing postoperative pain after routine dental treatment in     children. This study will be a prospective, placebo-controlled, randomized, double-blind     trial. Patients in need of dental treatment with local anesthesia will take part in the     study.      Study group will receive syrup paracetamol 15 min before the dental treatment. Control group     will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment.     the patient, the treating dentist, and the interviewer will be blind to the medication.      Main outcome measure: one of the main investigators will interview the patient at three time     points: immediately at the end of the treatment, one hour after taking the pre-operative     analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and     his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no),     needed a different kind of analgesics after the treatment (yes/no). In addition, each child     will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial     Rating Pain Scale   "
68405|NCT02390388|"     The aim of this prospective randomized study is to assess the analgesic efficacy and duration     of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias     surgery concerning intraoperative analgesic and also postoperative total analgesic     consumption within 24 hours.   "
68184|NCT02393274|"     Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and     respiratory support to patients with heart and respiratory failure. It can save time for     these organs to recovery or for these patients to receive further management. However, many     patients will die in spite of ECMO support. One of the key factor is whether the blood flow     provided by the ECMO can meet the requirement of organ perfusion. The adequacy of     macrocirculation may be determined by arterial pressure and minute blood flow of ECMO.     However, the adequacy of microcirculation remains as a major unresolved clinical problem.     This is a prospective observational clinical trial. The sublingual microcirculation will be     examined with the incident dark field video microscope within 6 hours after venoarterial ECMO     placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and     clinical data will be recorded as well. The major parameters of microcirculation include     total small vessel density, perfused small vessel density, and microvascular flow index. The     sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours     after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell     specific molecule-1 at specific time points will be examined. The data of 14-day mortality,     28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded.     This study aims primarily to investigate the relationship between microcirculation and     prognosis of these patients. This study will also investigate the relationship among serum     level of endothelial cell specific molecule-1, microcirculation, and prognosis of these     patients. Wish the results of this study can be applied in further research to help to     improve the quality of ECMO care.   "
68185|NCT02393261|"     This prospective, randomized, controlled, multi-center clinical trial will evaluate the     validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml     peritoneal dialysate.   "
68186|NCT02393248|"     The purpose of this study will be to evaluate the safety, tolerability, and pharmacological     activity of INCB054828 in subjects with advanced malignancies. This study will have three     parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).   "
68187|NCT02393235|"     Factors affecting the success of the treatment of infertility can evaluate before and after     embryo transfer in two stages. Most of the patients reach the embryo transfer stage.     Unfortunately, the investigators are able to intervene very few of the factors that will     affect the success of the post-transfer. All factors and treatments that affect the     implantation is vital to identify. Basically, healthy vasculature is essential for a     successful implantation. The investigators will try to understand relationship between     vascular resistance and type of infertility. The investigators will examine whether the     effect of the ovarian uterine and spiral artery resistance over infertility.   "
68188|NCT02393222|"     Stroke disease and cognitive impairment are common in patients established on haemodialysis     (HD) for end-stage renal disease (ESRD). Further, initiation of HD appears to transiently     increase the risk of stroke. The mechanism by which this occurs is not known.      Using ultrasound, patient questionnaires and brain MRI our study will observe changes in     cognition and cerebral blood flow whilst receiving HD compared to a non-dialysis day.     Transient clinical and ultrasound alterations will be correlated to radiographic changes in     cerebral perfusion and structure on MRI to determine the underlying mechanism for the     increased stroke risk. The investigators will observe this effect in the immediate and longer     term (12 months observation).      A greater understanding will allow development of effective preventive strategies.   "
68189|NCT02393209|"     The purpose of this study is to determine the recommended phase 2 dose (RP2D) of MLN1117 when     administered in combination with docetaxel in patients with non-small cell lung cancer     (NSCLC) and to evaluate efficacy, safety, and tolerability of MLN1117 administered alone and     in combination with docetaxel at the RP2D in patients with locally advanced or metastatic     non-small cell lung cancer.   "
68190|NCT02393196|"     The investigators aimed to compare the methods colloid preloading and colloid coloading in     terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second     aim while planning the present study is to identify the method of the lowest adverse event     for mother and infant and the simplest approach for the clinician.   "
68191|NCT02393183|"     This randomized clinical trial is designed to evaluate the effect of selected antioxidant     vitamins and minerals supplement B-Carotene (6 mg) + Vit.C (200 mg) + Vit.E (200 mg) + Vit.     Nicotinamide (20 mg) + Selenium (200 mic.)+ Zinc oxide (8 mg) + Copper oxide (1mg)     +Mangeneschloride (1.8 mg) in patients with mild Graves' orbitopathy according to EUGOGO     classification.   "
68192|NCT02393170|"     On-going rehabilitation is needed to maintain and improve the weaker upper extremity     following stroke. Community rehabilitation programs for stroke individuals in the chronic     stage are often difficult to be implement. Consequently, many individuals remain without     structured interventional programs. Self-training programs, where individuals can     independently continue to exercise at home, might answer this challenge. However, since     exercising alone is boring and not motivating, individuals often stop the prescribed     exercises and remain inactive. The use of video-games for self-training might answer this     challenge.      Therefore, the investigators aimed to assess the feasibility of using video-games for     self-training after stroke. Specifically the investigators aim to compare the (1) training     time, (2) satisfaction and (3) effectiveness of a self-training program using video-games     compared to a traditional self-training program.   "
68406|NCT02390375|"     The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients     with primary hypercholesterolemia   "
68193|NCT02393157|"     The purpose of this study is to determine the safety of administering obinutuzumab as a     single agent alone and in combination with ifosfamide, carboplatin, and etoposide (ICE)     chemotherapy and determine the response rate of this treatment for children, adolescents and     young adults (CAYA) with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL).   "
68194|NCT02393144|"     Primary aim of this study is to analyse contemporary labor patterns by measuring rate of     dilatation and head descent via transperineal ultrasonography. Labor curves will be generated     using data regarding rate of dilatation, head-descent obtained via transperineal     ultrasonography. Factors which are known to effect duration of labor will be taken into     account.   "
76469|NCT02284919|"     In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2     (σ2) receptor activity in sites of primary breast cancer using the investigational     radiotracer [18F]ISO-1.   "
68195|NCT02393131|"     Brain metastases are the most common brain tumors in adults. It is estimated that around     10-30% of cancer patients would develop brain metastases during the course of their illness.      Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with     brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in     rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function     decline caused by intracranial lesions. By using conventional fractionation, 33% of patients     developed late neurocognitive toxicity while memory impairment was the most common symptom.     The incidence is even higher when a formal and sensitive neurocognitive assessment was     prospectively evaluated. With more long-term survivors nowadays, it has become increasingly     important to minimize neurocognitive function decline and maintain quality of life in     patients with brain metastasis.      The function of hippocampus is cooperation in learning, consolidation and retrieval of     information and essential for formation of new memories. Bilateral and unilateral radiation     injury of the hippocampus is known to alter learning and memory formation. Several     preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by     ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is     associated with subsequent neurocognitive function impairment in adult and pediatric     patients. Furthermore, the preliminary result of Radiation Therapy Oncology Group (RTOG) 0933     suggested hippocampal avoidance significant reduce the mean relative decline at 4 months from     30% in historical cohort with WBRT to 7% in experimental cohort.      Previous studies showed brain structures other than hippocampus are also associated with     radiation-induced decline in neurocognitive function. There is presence of placebo effect for     interventions seeking improvement in neurocognitive function. In present study, a single     blind randomized phase II trial is designed to investigate the effectiveness of     neurocognitive function preservation using conformal WBRT with or without hippocampal     avoidance.   "
68196|NCT02393118|"     The BrainPort V200 Device is a wearable, non-surgical, prosthetic device intended for people     who are profoundly blind. The BrainPort V200 translates images captured by a digital camera     into electro-tactile stimulation presented on the user's tongue to perceive shape, size,     location, and motion of objects within the environment. The purpose of this study is to     evaluate the safety and functional performance of the BrainPort V200 device in individuals     who have been medically documented as blind, light perception or worse, due to a traumatic     injury (cortical or ocular).   "
68197|NCT02393105|"     This study explores the relationship between the sense of hope and fatigue in breast cancer     survivors and provides a reference for future planning improvements for breast cancer     survivors experiencing fatigue.   "
68198|NCT02393092|"     This study will evaluate the effectiveness of a hospital-community based violence prevention     pilot study designed to increase protective factors and reduce negative risk factors     associated with violence of children aged 10-15. Behaviors and attitudes that relate to     violence and behavior change will be assessed through a series of questionnaires administered     in an interview format. Assessments will occur every nine weeks. Additionally, objective long     term measures for violence related hospital visits, delinquency, and educational development     will be obtained.      The study will include the following interventions:        1. Brief violence prevention (BVP): a case manager administered psycho-educational          intervention that will include an interactive discussion with youth regarding resources          for remaining safe and preventing violence. The intervention will address the concerns          and questions of youth and youth will be given information on how to access community          based resources if needed.        2. Brief violence awareness (BVA): a packet of information about violence prevention and          local community resources.        3. Emerging Leaders: East End: a semester (17 weeks) long curriculum based positive youth          development education program held at the Boys and Girls Club of Metro Richmond, Martin          Luther King Middle School site that includes case management to ensure continued          engagement and participation.      Specifically, it is hypothesized that:        1. Participants will report more positive youth behaviors as compared to their initial          assessment.        2. Participants will report lower levels of risky youth behaviors compared to their initial          assessment.        3. Participants will report increased interest in and knowledge of health professions.        4. Participants will report reduced levels of delinquency compared to their initial          assessment.        5. Participants will report a reduction in the number of violence related hospital visits          compared to the general 23223 population.        6. Hospital data will show a reduction in violence related activities that led to hospital          visits, or delinquent behavioral involvement.   "
68199|NCT02393079|"     The purpose of this study is to evaluate the early and late effects of Transcranial Led     Therapy (TLTC) in memory and executive functions in patients with moderate and severe TBI     history in the initial phase (3-6 months).   "
68200|NCT02393066|"     This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery     were recruited to participate in the study. Apart from routine treatment in the surgical     intensive care unit, the subjects were randomly divided into two groups: Propofol group     (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of     Propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage     range: 0.1 ~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status     was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output     and Hemodynamic Monitor at preset time points (time of recruitment [0h], 2, 4, 6, 12h and     24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid     volume and drugs used were also recorded.   "
68201|NCT02393053|"     Background: This randomized controlled clinical study of split-mouth aimed to compare     non-pedicled buccal fat pad graft (BFPG) with subepithelial connective tissue graft (SCTG) in     the treatment of Miller Class I or II gingival recessions.      Methods: Twelve patients with Miller Class I or II (≥ 2 mm) bilateral recessions in maxillary     premolars or canines were selected. The recessions were randomly assigned to receive SCTG     (Control Group) or BFPG (Test Group). The clinical parameters of Gingival Index (GI), Plaque     Index (PI), Probing Depth (PD), Gingival Recession (GR), Clinical Attachment Level (CAL),     Width of Keratinized Tissue (WKT), Thickness of Keratinized Tissue (TKT) and Gingival Margin     to the Acrylic Guide (GM-AG) were evaluated at baseline, and in the postoperative periods of     1, 3, and 6 months. The percentage of root coverage was also evaluated. Data were submitted     to repeated measures ANOVA, Bonferroni method and t-test (p<0.05).   "
68202|NCT02393040|"     The purpose of this study is to determine the efficacy of treatment with Platelet-rich plasma     on Androgenetic alopecia (compared with placebo), between six months and baseline.   "
68211|NCT02392923|"     Cohort descriptive study of quality of life and body functions in a reference population of     Swedish inhabitants from age 30 to age 89. The population was selected to be representative     for the general Swedish population and 500 in each 10 year group, 250 men and 250 women.      The population is contacted and asked for informed consent, whereafter a questionnaire of     about 200 questions, used in a number of studies in clinical studies and trials, are sent     out.      The results will be used as reference values to our patient cohorts   "
68213|NCT02392897|"     Eating frequency may play an independent role in appetite regulation, overall caloric     consumption and measures of long-term health or disease risk. Some literature recommends     frequent eating, but pilot data suggest that this type of eating pattern may be harmful to     health since it leaves the body in a perpetual fed state and increases systemic inflammation.     Therefore, the investigators will conduct a clinical trial in 50 healthy adults to compare a     low frequency eating pattern to a high frequency eating pattern in relation to blood-based     markers of inflammation, metabolic health and appetite. Study results will be applied to     recommendations for eating frequency in the context of an overall healthy diet.   "
68214|NCT02392884|"     The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation     impacts medication adherence in HIV-1 seropositive individuals.   "
68203|NCT02393027|"     Idiopathic Parkinson's disease (IPD) is a degenerative disease affecting the dopaminergic     system. Clinical symptoms of IPD commonly begin after the loss of at least 40 to 50% of     striatal dopaminergic terminals (specially putaminal terminals).      The Dopamine neuronal transporter (DAT) is a highly expressed protein in the membrane of     presynaptic nigrostriatal dopaminergic terminals. The use of a DAT's radioligand in the     initial stages of the disease would lead to an early detection of nigral cell loss.      Currently, only one DAT's radioligand has obtained marketing authorization in France, the     123I-FPCIT, for use in Single Photon Emission Computed Tomography (SPECT).      Otherwise, the Positron Emission Tomography (PET), a more sensitive technology than SPECT     with higher resolution has become for a few years the new gold standard for visual analysis     and quantification of neurotransmission systems (including the dopaminergic system).      A DAT tracer labelled with Carbon 11 ([11C] PE2l) have been developed and is currently used     as a reference in various research centers.      However, in order to enable a clinical use of this tracer (which currently can't be because     of the too short period of Carbon 11), the unit INSERM U930 Imaging and Brain in     collaboration with the CERRP (Center for Studies and Research on Radiopharmaceuticals)     developed a new version of this tracer, labelled with 18-fluor: the [18F] LBT-999.      The main goal of this study is to compare the [18F] LBT-999 uptake between a group of     patients suffering from a Parkinsonien syndrome to a group healthy volunteers.   "
68204|NCT02393014|"     This study aims to evaluate the feasibility and the impact on physical performance and falls     occurence among geriatric inpatients hospitalized in acute care unit.   "
68205|NCT02393001|"     The purpose of this research study is to determine if a very sensitive chemistry lab analyzer     can be used to smell a skin cancer (like melanoma) similar to some dogs.   "
68206|NCT02392988|"     In recent years, it is accepted to induce birth at week 41 in order to reduce the risk in     surplus pregnancies. It was found that after 41 weeks, there is a significant increase in     pregnancy complications including meconium liquor, shoulder dystocia and fetal death in     uterus.      Induction at 41 weeks was found to reduce the risk of complications described above, without     taking the risk of cesarean section and, therefore, the recommendation of the Israel Society     of Maternal Fetal Medicine, is to induce birth for women who completed 41 weeks of pregnancy.      Induction is performed mechanically by entering a balloon to the cervix or by medicated     prostaglandins and later, intravenous Pitocin to most women. The process takes two to three     days with about 60-70% success rate.      In recent years there has been a growing awareness to use natural methods to start labor.      Many women tend to turn to natural medicine in order to reduce the need for conventional     drugs to start labor.      Given the lack of research on the issue and considering the rising demand of the involvement     of alternative medicine in labor induction process, the investigators decided to carry out     research on this subject.   "
68207|NCT02392975|"     This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young     children with Traumatic brain Injury (TBI).      In children, TBI causes >2000 deaths, 35,000 hospitalizations and 470,000 emergency     department visits in the US each year, making it a leading cause of pediatric disability and     death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing     them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially     increased in children because the neurologic exam is less reliable, because growing tissues     are more vulnerable to radiation, and because children have more years to accumulate harmful     mutations.      Fast MR is a short, motion-tolerant protocol that has been used in children with shunted     hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR     has not been validated in children with TBI, a critical gap. The investigators will measure     feasibility and diagnostic utility of fast MR in children < 6 years (72 months) old who     undergo head CT for TBI.      The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting     subjects will undergo fast MR shortly after CT and results will be compared to determine: 1)     whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR     without sedation can be performed quickly and successfully.   "
68208|NCT02392962|"     All the athletes should perform a warm-up consisting of five minutes of jogging and static     stretching (Experimental Group 1) or dynamic stretching (Experimental Group 2). Before the     beginning of the study and right after performing the stretching protocol, the investigators     evaluated the unipedal postural stability, the acustic reaction time, the joint position     sense of the knee and the countermovement jump of the athletes.   "
68209|NCT02392949|"     Previous studies have shown that peripheral muscles weakness or inhibition is related to     spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle     weakness for patients with spinal pain. The purpose of the study was to assess the effect of     spinal mobilization on the maximal muscle strength of the shoulders.   "
68210|NCT02392936|"     There is a recent increase in incidence of surgical site infection after cardiac surgery in     our hospital, in spite of specific measures taken concerning some aspects of the surgical     procedures, targeting a better control of the classically known major risk factors of     infections, in routine procedures involving a sternotomy such as coronary artery bypass     graft, valvuloplasty, aortic surgery, or combined procedures.      The first objective of this monocentric prospective cohort study, is to evaluate     underestimated specific risk factors of surgical site infection, during the perioperative     period, for patients undergoing cardiac surgery with sternotomy.      Secondly, to estimate the specific risk associated with each class or micro-organisms     responsible, and their profile of resistance.      The outcomes concern the occurrence of a surgical site infection diagnosed by the surgeon in     charge of the patient, one month and three months after surgery; it may concern the pre     operative period, the procedure itself, or the early post operative period, characterized by     a high density of cares, or even the late rehabilitation, after discharge of the surgical     unit.      Secondary outcome evaluate the profile of agents identified regarding the susceptibility of     the prophylaxis recommended to prevent wound infection; it may suggest that an adequate     antibiotic prophylaxis is often insufficient to take into account the responsible agents, and     that decolonisation is not always that helpful, in view of emerging cases of failure due to     developing resistance.      Considering the low incidence of that type of complication, the investigators estimated that     a period of two years might be necessary to include a sufficient number of patient, at least     one thousand, in order to find a dozen of factors that might be significantly associated with     an increased risk of surgical site infection.      The evaluation is permitted by the collaboration between the anesthesiologists, surgeons,     intensivists, hygienists, all along the presence of the patient in the department, until     discharge out of the hospital and after readmission eventually for infectious complication.   "
68212|NCT02392910|"     Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well     as impairing health-related quality of life in chronic heart failure (CHF), and these effects     are compounded when patients also experience chronic kidney disease (CKD). This study was     designed to determine the effects of intravenous iron treatment on morbidity and mortality     following an initial 6-month period and a longer period of up to 5 years.   "
68216|NCT02392858|"     Influenza is a major cause of morbidity and mortality. The investigators first goal is to     evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death     from Influenza respiratory illness in adult and pediatric patients hospitalized in     reanimation. Secondly, the investigators collected respiratory samples in order to study the     transcriptomic profiles of influenza-infected patients with severe symptoms.   "
68217|NCT02392845|"     To determine the maximum tolerated dose of a densified regimen of the association of     docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of     hematopoietic growth factors in patients with metastatic breast cancer in first-line,     optimizing in each patient the administration schedule using a formal procedure based on     mathematical models in order to manage the severity of induced neutropenia.      The models used in this project allow:        -  an optimal administration schedule of the planned total dose per cycle (number of          infusions and calculating their rates and durations)        -  an individualization of the administration schedule from the second cycle (based on          observations from the first cycle), and        -  an assessment of the risk of a dose-limiting toxicity event combining several severe          non-hematological toxicities (conditioning the decision for dose escalation).      Using formal mathematical models the investigators expect controlling the hematological and     non-hematological toxicities in order to realize the full series of six cycles of densified     DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is     considered feasible if it is possible, in the absence of tumor progression, to consider 6     cycles of treatment without observing any serious adverse events and without:        -  patient death that may be related to the treatments;        -  decision of the patient to interrupt treatment for physical or psychological tolerance          reasons;        -  decision of the investigator to discontinue treatment, in the absence of disease          progression.   "
68218|NCT02392832|"     In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual     spraying (IRS), together with the introduction of artemisinin-combination treatments, have     led to substantial reductions in malaria prevalence and incidence in African highlands.     However, rising insecticide resistance and increased outdoor transmission have greatly     hampered the effectiveness of ITN and IRS because the current indoor-based interventions do     not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can     tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The     central objective of this study is to determine the efficacy and cost-effectiveness of     EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical     malaria incidence in western Kenya highlands.   "
68219|NCT02392819|"     This project evaluate effects of a commonly used food supplement on glucose metabolism and     cognitive function.   "
68220|NCT02392806|"     Multiple different devices are available to provide Bubble CPAP to preterm and newborn     infants. The most significant difference between these devices is the size of the bubble     produced by the exhalation limb. This study will determine if one Bubble CPAP device     (BabiPlus vs B&B) is more effective in improving oxygenation and decreasing extubation     failure in the extremely low birthweight population.   "
68221|NCT02392793|"     The drug, talazoparib, seems to work against cancer in test tubes and animals by preventing     DNA repair in damaged cells leading to their death. Investigators do not know if talazoparib     combined with irinotecan will work in humans. Talazoparib has been used in only a small     number of adults and children, and there is much not yet known about it.      In Arm A of this study, investigators seek to find the safest dose of irinotecan to give with     talazoparib to children and young adults. In a phase I study, different dose levels of drug     may be tested. The first 2 or 3 patients will be given a dose, and if none of them has a bad     side-effect, the next 2 or 3 patients will be given a higher dose. No temozolomide will be     given in in Arm A.      The experimental drug combination of talazoparib and irinotecan will be tested in the hopes     of finding a treatment that may be effective against recurrent or refractory solid tumors.     The goals of study Arm A are:        -  To determine whether the combination of talazoparib and irinotecan is a beneficial          treatment for your cancer;        -  To learn what kind of side effects talazoparib can cause;        -  To learn what kind of side effects talazoparib in combination with irinotecan can cause;        -  To learn more about the biology of talazoparib in children diagnosed with solid tumors.      The purpose of Arm B is to to find the safest doses of irinotecan and temozolomide to give     with talazoparib to children and young adults with a solid malignancy.. Talazoparib belongs     to a family of drugs called poly ADP ribose polymerase or PARP inhibitors. Irinotecan and     temozolomide belong to a family of drugs called DNA damaging agents.      There are two arms of this trial, A and B. In this study, investigators hope that irinotecan     (administered in Arm A) and irinotecan plus temozolomide (administered in Arm B) will damage     the DNA of the cancer cells. Then, talazoparib (which is a PARP inhibitor) will block the     repair of the cancer cell's damaged DNA, causing the cancer cell to die (a process called     apoptosis).      There are different types of cancers found in children and young adults which appear to be     vulnerable to the combination of chemotherapy agents that will be given in this study. Work     carried out in the lab show that these agents may be very promising in the treatment of ewing     sarcoma, germ cell tumors, wilms tumor, medulloblastoma and possibly neuroblastoma.   "
68233|NCT02392637|"     The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to     gemcitabine and cisplatin can help to control metastatic (has spread) or unresectable (cannot     be removed by surgery) biliary cancer. The safety of this drug combination will also be     studied.   "
76394|NCT02285894|"     This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can     open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated     patients.   "
68222|NCT02392780|"     Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic     cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis     sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase     2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD     compared to control patients with a hazard ratio of 0.3. Based on these results the     investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of     severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.   "
68223|NCT02392767|"     The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2,     R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind     placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia     are randomly assigned to the dietary supplement or placebo.   "
68224|NCT02392754|"     Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to     detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring     technologies have the potential to improve early detection of AF. This trial investigates AF     screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor     that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home     blood pressure monitor that has built-in AF screening capability.   "
76511|NCT02284373|"     The purpose of this study is to evaluate the effect of pneumatic compression in improving     symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.   "
68226|NCT02392728|"     The mood disturbances that lung cancer patients experience during and after chemotherapy have     a debilitating effect on their quality of life. The goal of the proposed project is to     develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to     combat the adverse psychological/emotional consequences of receiving treatment for lung     cancer. Although VR has been used with success to treat various psychological conditions     (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood     and hence better quality of life has not yet been tested. In this project the investigators     will first develop the virtual content (e.g., natural scenes) that patients will experience     within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The     investigators will then carry out a randomized, double blind, crossover trial with 50     hospitalized lung cancer patients to test whether they can benefit psychologically and     emotionally from their interaction with an immersive environment compared to those who will     experience a guided imagery intervention. A positive result will open the route for the     future development of affordable self-administered VR solutions for treating the     psychological side-effects of lung cancer treatment.   "
68227|NCT02392715|"     Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing     prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner     stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases     dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary     benefit in the rehabilitation of COPD patients is however uncertain.   "
68228|NCT02392702|"     This two-part study will assess, in healthy volunteers, under both fasted and fed conditions,     and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of     single doses of C-10355 and C-10358 and single ascending doses of the selected compound     compared to a single dose of Kalydeco®.   "
68229|NCT02392689|"     Patients presenting to the Emergency Department with shortness of breath and (suspected)     heart failure will be screened and randomized to either a standard of care or a     procalcitonin-guided arm.      Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support     decision on antibiotic therapy initiation.      Standard of care arm: the decision on antibiotic therapy will be based on the physicians     intent to treat.      The patients will be followed up 30 and 90 days after randomization to evaluate the survival     status, re-hospitalizations and further antibiotic therapies.   "
68230|NCT02392676|"     Olaparib administered as monotherapy in the maintenance setting improves progression free     survival compared to placebo in patients whose tumours carry loss of function (deleterious or     suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected     deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR) -associated genes who     have a complete or partial response to platinum-based chemotherapy.   "
68231|NCT02392663|"     This study aims to analyze whether the hypertonic saline nebulization enhances sputum     clearance effects, reduces the impact on cough severity and their level of safety and     tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition,     this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic     saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).   "
68232|NCT02392650|"     Hominids and hominins serve as remarkable hosts to microbes, and we have co-evolved over the     past 4.5 million years as highly plethoric communities. Human-associated microorganisms (the     microbiome) are present in numbers exceeding the quantities of human cells by at least     10-fold beginning in the neonatal period. The collective genome (the metagenome) exceeds     our human genome in terms of gene content by more than 150-fold. With respect to microbiota     and preterm birth, it has generally assumed that the majority of intrauterine infections     originate in the lower genital tract, with microbiota ascending into the otherwise sterile     intrauterine environment to infect the placenta (preterm birth), fetal membranes     (chorioamnionitis), umbilical cord (funisitis), and the fetus (sepsis). However, we and     others have recently demonstrated that the vaginal and gut microbiome communities are     distinctly structured in pregnancy, and the placenta is in fact not sterile, but rather     harbors a low-abundance microbiome which is likely acquired through hematogenous transmission     of the oral microbiome.      Based on our prior studies and preliminary data, our central hypothesis is that a distinct     and largely commensal resident microbiome in pregnancy renders risk for preterm birth. By     utilizing our state-of-the-science technology and analysis tools in a longitudinal     case-cohort of preterm birth subjects, we will be able to transform discovery based     metagenomics and multi'omics science into readily translatable mechanistic studies at a     previously unparalleled level.   "
68234|NCT02392624|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48     weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After     completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg)     every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio     (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a     further 24 weeks.   "
68235|NCT02392611|"     This study will evaluate the safety, tolerability, pharmacokinetics (PK), and     pharmacodynamics (PD) of GS-5829 in adults with advanced solid tumors and lymphomas and in     combination with exemestane or fulvestrant in adults with estrogen receptor positive breast     cancer.   "
68236|NCT02392598|"     This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of     patients with chronic hepatitis B.   "
68237|NCT02392585|"     The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss     at open myomectomy.   "
68238|NCT02392572|"     The goal of Phase I of this clinical research study is to find the highest tolerable dose of     ONC201 that can be given to patients with relapsed or refractory AML, ALL, or MDS.      The goal of Phase II of this study is to learn if the dose of ONC201 found in Phase I can     help to control the disease. The safety of the study drug will be studied in both phases of     this study. This is the first study using ONC201 in humans. ONC201 is in a very early stage     of development for use in humans. Providing direct medical benefit to you is not the purpose     of this study. While Phase II will look at the effectiveness of the study drug, the main     purpose of this study is to learn about the safety of the drug.   "
68241|NCT02392533|"     Ultrasonography is routinely performed during pregnancy by obstetricians to visualize the     fetus, making patients familiar and comfortable with its usage. Ultrasonography does not     result in adverse effects to the mother or fetus and is readily available at most facilities,     yet is not routinely used to identify lumbar interspaces prior to providing neuraxial     anesthesia. Ultrasonography is a valuable tool for accurately identifying lumbar     intervertebral spaces and is more accurate than simple palpation of obscure anatomic     landmarks. The investigators are interested to know the accuracy of anatomic landmark     palpation in predicting the lumbar interspace of neuraxial anesthesia administration compared     to identification of the interspace by ultrasound. The investigators are also interested in     presenting anesthesia providers with feedback regarding their accuracy and then investigating     whether this feedback causes a change in provider practice (i.e. use of ultrasound) or     improved identification of the interspace prior to providing neuraxial anesthesia.   "
68242|NCT02392520|"     The study aims to compare the novel method of GnRH antagonist administration in the luteal     phase versus conventional treatment in IVF patients who develop severe early ovarian     hyperstimulation syndrome and have all their embryos cryopreserved.   "
68243|NCT02392507|"     The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus     necitumumab is effective and safe in participants with stage IV squamous non-small cell lung     cancer.   "
68244|NCT02392494|"     The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to     determine the ability of MK-1075 to reduce HCV viral load, following administration of a     single dose in HCV-infected participants.   "
68245|NCT02392481|"     The main objective of the trial is to explore if any of the biomarkers assessed are     sensitively linked to the asthma phenotypes. This would potentially alone or in addition to     other clinical or biofluid markers indicate if and how asthma endotypes are linked to     phenotype such as eosinophilic, neutrophilic, or paucigranulocytic phenotypes. Further     exploratory markers will be analysed for better understanding of physiological levels of     proteins and markers playing a role in regard to disease characterization in asthma. As a     basis for further development of a biomarker for asthma, The sponsor plans to conduct this     exploratory biomarker trial to determine levels and reference ranges of biomarkers     potentially associated with asthma phenotypes. The trial aims at generating a panel of serum     biomarkers that can be evaluated in subsequent interventional studies. The longitudinal     design will be used to ascertain stability and test-retest reliability.   "
68246|NCT02392468|"     Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate     the ocular and systemic safety and pharmacokinetics during 14 day treatment period in     patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.   "
68247|NCT02392455|"     This observational study will investigate the efficacy and tolerability of Vargatef     (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally     advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC     patients, for whom the treating physician has decided to initiate treatment with Vargatef in     second line according to the local label, will be observed for up to 24 months. Survial     follow-up will be done until the end of the study.   "
68248|NCT02392442|"     Background:      - When bacteria enter the lungs, serious infections can occur. Researchers want to learn more     about the process of inflammation in the lungs by studying lung cells and the products that     they make. Lung cells are influenced by infections, smoking, and molecules made within the     body. Researchers also want to learn more about one of these molecules, called microRNA (or     micro ribonucleic acid).      Objective:      - To better how the body responds to infection. Also, to understand which cells in the lung     secrete microRNA and how they may influence other lung cells.      Eligibility:      - Healthy, non-smoking adults ages 18-45.      Design:        -  Participants will be screened with a medical history and physical exam. They will have          blood and urine tests and an electrocardiogram.        -  Participants will have blood drawn from an arm vein. They will have an intravenous          catheter (small plastic tube) placed in a vein.        -  All participants will have bronchoscopy with bronchoalveolar lavage. They will be numbed          with medicine. A thin flexible tube will be placed through the nasal passages or the          mouth into the airways of the lung.             -  Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the               airways with salt water) in order to obtain cells from lung. The water will then be               suctioned out.             -  Some participants will have two bronchoscopies; during the first procedure,               endotoxin, a molecule found in bacteria is squirted into a small portion of the               lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6 to               48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at the               lung s response to endotoxin.        -  Participants heart rhythm and rate, temperature and blood oxygen level will be monitored          during the procedures.        -  Participants will be called the next day to see how they are feeling.   "
68249|NCT02392429|"     This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography     (PET)/computed tomography (CT) in measuring response in patients with previously untreated     acute myeloid leukemia. FLT is a radioactive substance that may light up where cancer is in     the body. FLT is injected into the blood and builds up in cells that are dividing, including     cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to     earlier treatment.   "
68250|NCT02392416|"     Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart     Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias)     These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation     and taking into account specific parameters in the patient's profile.   "
68251|NCT02392403|"     The aim of this study is to investigate the clinical benefit for patients implanted with the     Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode     design.      Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the     cochlea through a straightening sheath.   "
68252|NCT02392390|"     The main objective of this study is to estimate the change in the relative numbers of     commensal or low virulence potential bacteria before and after one session TDP.   "
68253|NCT02392377|"     This randomized pilot phase II trial studies how well molecular phenotyping works in     predicting response in patients with stage IB-III esophageal cancer who are receiving     carboplatin and paclitaxel or oxaliplatin, leucovorin calcium, and fluorouracil. Studying the     genes in a patients tumor cells before, during, and after chemotherapy may help in     understanding if there are specific features of the tumor cells that make a person more or     less likely to respond to treatment and how these features may be affected by treatment.   "
68254|NCT02392364|"     The purpose of this study is to compare the safety and efficacy of intravitreal Eylea     injections at a set interval, versus a variable dosing schedule (likely longer than one     month), based on a specific individual's disease progression. There will be approximately 50     men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part     in this study at 5 locations in the United States.   "
68255|NCT02392351|"     The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™     Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment     office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8     weeks when compared to a masked procedure (renal angiogram).   "
68256|NCT02392338|"     In this study, the investigators therefore comparatively analyzed the mid-term results (at 1     year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term     electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid     procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic     medication, discontinuation of anticoagulation medication, and echocardiographic findings     were also analyzed.   "
68257|NCT02392325|"     Dengue viruses infect millions of people throughout the tropics and subtropics each year. The     development of a dengue vaccine is an important health priority. This study will evaluate the     immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy     adults with no history of previous flavivirus infection.   "
68258|NCT02392312|"     A multicenter, prospective, observational study to evaluate the safety and efficacy of     individual batches of ATG-F in kidney transplant recipients.   "
68259|NCT02392299|"     The purpose of this study is to explore the relative importance of the frailty and     cardiovascular function as potential exercise-modifiable risk factors for falling in patients     receiving haemodialysis.   "
68260|NCT02392286|"     Prospective randomized comparative effectiveness trial designed to compare fixed dosing and     weight-based dosing of corticosteroids in patients with Crohn's disease flares.   "
68261|NCT02392273|"     This study is an observational study with the primary objective to assess the safety and     tolerability of Ausanil in the treatment of primary headache disorders. The secondary     objective is to assess headache pain, functional outcome, time loss to headache and patient     satisfaction with Ausanil treatment.   "
68262|NCT02392260|"     This project is part of the EU funded project NISTAS. NISTAS aims at the development of a new     medical device for non-contact, non-invasive screening of the health status of the vascular     system of adult subjects. The instrument, called VascuLight, is intended to be deployed at     out-patient points-of-care and hospitals, and it provides output parameters related to the     PWV as measured at local and/or at regional level.      NISTAS brings together four European SMEs in four different, but complementary, technology     areas (JULIGHT, ECLEXYS, EPI-LIGHT, OIP) and links them with five RTD Performers (UNIPV, OSM,     CORK UNIVERSITY, Saphyrion, Eudax srl ) to develop new knowledge and a new medical device     which will have significant commercial benefits for all of the SME partners.      VascuLight responds to an unmet need in the medical diagnosis practice: the request for a     fast and sustainable method for the screening of the health of the vascular system in large     series, capable of providing a reliable indicator of the cardiovascular risk of the screened     subjects.      The VascuLight idea is founded on a paradigm shift: bringing and adapting to the biomedical     field measurement techniques that are to date confined to the industrial environment. NISTAS     will develop new non-contact distance/displacement/vibration sensors based on a variant of     the well-known and reliable laser triangulation technique.      JUL and UNIPV have carried out proof-of-concept, in-vivo tests of the VascuLight approach to     demonstrate that the concept is realistic and attainable. Results have been obtained using     Laser Doppler Vibrometry (LDV), a displacement-measuring technique based on the principle of     light interference, and an area where both JUL and UNIPV have made important contributions.     In the tests it was possible to use TWO small LDV optical heads to simultaneously measure the     pulse wave in two points on the carotid spaced by 2.5 cm, allowing for the calculation of the     time-delay between the pulse waves, and thus providing a direct local measurement of the PWV.      The aim of the study is to test the implemented contactless optical technique for the     measurement of the PWV and the arterial stiffness at the carotid artery level.      To evaluate the validity of the measure method, the investigators will compare Vasculight     v1.0 PWV measures with those obtained from e-tracking (echocardiographic method) . The main     idea is to compare the distribution of measures (comparable mean and standard deviation) in     the same mixed adult population, using the two different methods.   "
68263|NCT02392247|"     This study compares the results of current standard coagulation measurement devices to the     Quantra System, a new device, using small amount of extra blood obtained during routine blood     draws in cardiac surgery patients.   "
68264|NCT02392234|"     The purpose of this study is to evaluate the efficacy of VX-661 in combination with ivacaftor     and ivacaftor monotherapy in subjects with Cystic Fibrosis (CF).   "
68347|NCT02391142|"     The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on     Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac     structure, systolic function, electrical activities and concentration of B - type natriuretic     peptide precursor in patients with Chronic Heart Failure.   "
68265|NCT02392221|"     Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD)     and may affect all segments of the digestive tract. These are diseases of multifactorial     origin in which environmental and genetic factors are predominant.The EPIMAD registry, the     world's largest epidemiological register for IBD, identifying all incident cases in the four     departments of the North West of France showed between 1988 and 2007, an increase in the     annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p <0.0001) in the     age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105     inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The     increase in the incidence of CD will contribute to increase its weight in the health system,     particularly in the pediatric CD frequently associated with an aggressive phenotype causing     specific complications such as malnutrition, pubertal delay or thrive. These complications     have a important impact on the quality of life with a long-term risk of functional     disability. They may be associated with increased mortality. Immunosuppressants     (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF     antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have     profoundly changed the management of pediatric IBD. Although there is little data on the     impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems     to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be     associated with more frequent and deeper remission. With the advent of these new treatment,     new therapeutic targets such as endoscopic mucosal healing and more recently the deep     remission combining clinical remission, biological and endoscopic, appears. However there is     no data in the general population assessing the impact of new treatments and new therapeutic     strategies in the pediatric population. Potential risks associated with the increasing use     and early use of biological treatments in this particular population remain to be determined     in the general population.      The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed     before 17 yeras old could influence the cumulative incidence of surgical resection and     complications specific to this population as failure to thrive and delayed puberty, insertion     socio-professional, the extension of the disease, hospitalization rates, and the rate of     cancer.   "
68351|NCT02391090|"     Stable Asthma patients (GINA 1-2) stay 6 days in a row for 4 hours per day in a hypoxic     chamber simulating 2800m above sea level. Study participants will be blinded to the treatment     given and divided into a hypoxic and a sham group (about 360m above sea level).      Effects of this intermittent hypoxia on the asthmatic inflammation of these patients will be     measured. The primary endpoint is the change in forced exhaled nitric oxide (FeNO) before and     after the study. Secondary endpoints include blood parameters, lung function testing and     questionnaires.   "
68352|NCT02391077|"     There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space,     therefore we would like to investigate possible techniques to reduce this potential.   "
68266|NCT02392208|"     Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an     increased risk for developing bloodstream infections. Vancomycin is traditionally used as     first-line therapy for treating these infections, but the emergence of less-susceptible     bacterial strains necessitates the consideration of alternative antibiotic therapy.     Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against     gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing     recommendations for telavancin are available for patients with normal kidney function, there     are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic     study is needed to characterize the pharmacokinetic parameters of telavancin in these     patients to determine the extent of drug removal by hemodialysis and to establish dosing     recommendations for CKD5 patients on maintenance hemodialysis.   "
68267|NCT02392195|"     This study will enable investigators to find out if brain structure and characteristics are     affected by the shape of the infant's head, and if changes in the brain occur with helmet     therapy.   "
68268|NCT02392182|"     In its original phase, this cohort study recruited subjects who were either HIV-positive or     HIV-negative healthy controls, to analyze the community structure of the lung microbiome.     Original recruitment was planned to occur both at the University of Michigan Medical Center     and clinics, and at VA Ann Arbor Healthcare System.      Enrollment for the original cohort is completed, and all current activity of this project is     occurring at VA Ann Arbor, where both Veteran subjects and non-Veteran subjects are eligible     to participate. This study is currently recruiting only healthy HIV-negative subjects.     Participation, described below, involves a research bronchoscopy procedure.   "
68269|NCT02392169|"     Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and     adolescent psychiatric disorders. In recent years, some researchers have become interested in     analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone (DHEA),     dehydroepiandrosterone sulfate (DHEA-S), cortisol and testosterone. Previous work in ADHD has     established a strong heritable component to the phenotype. The STS gene, SULT2A1 gene and TH     gene are associated with the function of DHEA/DHEA-S, and the NR3C1 gene is associated with     the regulation of cortisol. Therefore, the relationship between these genes and the etiology     of ADHD warrants investigation. Moreover, compared to the phenotype, the endophenotypes of     ADHD may be more capable of detecting the underlying neurobiological and hereditary     mechanisms. Therefore, this study aims to investigate the relationships between     neuroendocrine substrates (DHEA, DHEA-S, cortisol and testosterone), candidate genes (STS     gene, SULT2A1 gene, TH gene and NR3C1 gene) and the phenotype and endophenotypes (disease     subtypes, neurocognitive function and response to treatment) of ADHD.      To complete this work, we will recruit 300 patients with ADHD (probands) and 600 biological     parents of the probands. DNA will be extracted from buccal cells by cheek swab. At baseline,     saliva samples of ADHD patients will be collected between 7:00 and 8:00 am using the passive     drool method, to analyze the levels of neuroendocrine substrates. The patients will undergo     assessment for their clinical symptoms and neurocognitive function. Methylphenidate will then     be administered to the patients and the usual practice followed. At week 4 and week 52,     procedures similar to those performed at baseline will be repeated.      The results of this study may further elucidate the complexity of the pathophysiology of     ADHD. We may determine whether the neuroendocrine system, which contains levels of     neuroendocrine substrates and associated genes, plays a crucial role in the phenotype and     endophenotypes of ADHD. The information may serve as an important reference for the direction     of future study and clinical treatment for patients with ADHD.   "
68270|NCT02392156|"     The primary objective of the study is to evaluate the effectiveness of prophylactic treatment     with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion     protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes     while maintaining disease control in males with hemophilia A or B.   "
68271|NCT02392143|"     The purpose of this study (Healthy Colon Project II) is to evaluate different educational     approaches for increasing rates of colorectal cancer (CRC) screening in a hard-to-reach urban     minority population with health insurance.   "
68272|NCT02392130|"     The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin     thickness in healthy skin treated with steroid.   "
68273|NCT02392117|"     This study is conducted in Europe. The aim of this non-interventional study is to investigate     the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with     type 1 (T1DM) and 2 (T2DM) diabetes mellitus.   "
68274|NCT02392104|"     The purpose of this study is to determine the feasibility, safety, and acceptability of     implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin     in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.      All participants will be provided usual care from the anticoagulation clinic, except for the     interval between INRs. If the participant continues to be on a stable dose of warfarin and     the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be     scheduled following an extended interval protocol. Patient satisfaction will be evaluated at     various points throughout the study. Additionally provider satisfaction, confidence, and     knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic     events will be evaluated to ensure the safety of an extended follow-up interval.   "
68275|NCT02392091|"     The aim of this study was to investigate the prevalence, type, and possible risk factors of     RTA in critically ill patients using a physical-chemical approach.   "
68276|NCT02392078|"     The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is     being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS     has been used in over 1300 procedures conducted at approximately 56 leading institutions     across United States. This is a prospective, multi-center registry that will include data     collection up to 12 months to evaluate procedural success, local control failure rate, and     QoL in up to 1,000 patients and up to 50 sites. Currently, the study has 162 subjects     enrolled from 14 active sites   "
68277|NCT02392065|"     To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery     population and establish links between COPD status, as assessed through pulmonary functional     tests, and 2-year mortality   "
68356|NCT02391025|"     This is a single center cross-sectional imaging study investigating the use of gallium-68     citrate PET in patients with metastatic castration-resistant prostate cancer who are planning     to undergo a metastatic tumor biopsy on protocol CC# 125519.      The study population will consist of patients with metastatic castration-resistant prostate     cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol CC# 125519,     with evidence of resistance to androgen signaling inhibition.      The study will involve gallium-68 PET scan obtained at single time point, followed by     radiographically-guided metastatic tumor biopsy within 14 days of PET scan.   "
76994|NCT02278042|"     The purpose of this study is to investigate the acute and chronic effects of consumption     fructose containing sugars and glucose in a real word setting when consumed in a manner and     amount typical in the American diet.   "
68278|NCT02392052|"     Spinal cord injury (SCI) may result in physical deficits that require assistance from others     in order to stay healthy and live independently in a community. The assistance provided by     caregivers to a family member with SCI often involves a wide range of activities from helping     with basic activities, like toileting and bathing, to managing more complex tasks, such as     keeping up with household finances, shopping, and transportation. Caregiving puts demands on     an individual's ability to cope and deal with day-to-day stresses, and may be influenced by     personal beliefs about one's ability to cope with stress. Beliefs about our ability to     perform tasks that affect our lives have been termed self-efficacy. A strong sense of     self-efficacy has been shown to positively impact life choices, motivation, quality of     functioning, resilience to adversity, and vulnerability to stress and depression. People with     low self-efficacy tend to avoid challenges, discontinue tasks that are difficult, and be at     risk for more depression and stress, resulting in less satisfaction with life.      This study uses a psychological strategy, called cognitive behavioral therapy (CBT), to     enhance self-efficacy skills for caregivers of family members with SCI, with a focus on     changing thinking styles to help people make emotional and behavioral changes. The     investigators hypothesize that by providing family caregivers with a six week group     educational intervention, their self-efficacy skills as well as general life satisfaction can     be improved, and minimize depression, stress and anxiety that often accompany the caregiving     role. The innovation of the proposed intervention is its integration of positive     psychotherapy concepts into structured group CBT to develop optimistic self-efficacy beliefs,     strengthen the caregiver's ability to deal with day-to-day stress, and enhance a sense of     well-being in the caregiver which, in turn, may benefit the family member with SCI.   "
68279|NCT02392039|"     The goal of this clinical research study is to learn if loratadine can control bone pain     caused by pegfilgrastim (a drug given after chemotherapy to help raise white blood cell     counts).   "
68280|NCT02392026|"     Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal     Gel in females 12 to <18 years for the treatment of bacterial vaginosis.   "
68281|NCT02392013|"     This study evaluates the effectiveness and implementation of a home-hazard removal program to     reduce falls in older adults through a community program delivered through the aging services     network. The investigators will conduct a hybrid effectiveness/implementation trial of 300     older adults at risk for a fall who will be randomized to a home-hazard removal program or     usual care and then followed for 12 months.   "
68282|NCT02392000|"     Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia     (trouble falling or staying asleep). Most current interventions for insomnia are     time-consuming, making it difficult for this younger, working group of Veterans to use and     benefit from these interventions. The investigators will assess whether Veterans find it     helpful to use two health information technology tools, one for measuring participant sleep     (the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will     measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile     health application used on the Veteran's mobile phone or tablet to teach skills that can     reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so     Veterans can self-manage insomnia at home. Participants will record their physiological sleep     and self-report on their sleep at home during a 6 week self-management program. The     investigators will measure if Veterans find the tools helpful and easy to use, and which     Veterans find the tools most helpful.   "
68283|NCT02391987|"     This study evaluates the effectiveness of remote tele-monitoring and health coaching in     helping to reduce hospitalizations in heart failure patients. Half of participants will     receive tele-monitoring and health coaching, while the other half will receive standard     health care provided by their chosen provider.   "
68284|NCT02391974|"     This is a controlled, randomized, single-blinded, multicenter, prospective clinical study.      In addition to the standard periodontal treatment procedure on all teeth that need to be     treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to     either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.      The pocket depth will be measured at six sites around each tooth, and only the deepest pocket     sites of each tooth will be taken into account.   "
68285|NCT02391961|"     Primary fatigue represents a major cause of disability in patients with multiple sclerosis     (MS), being reported in about 90% of cases. Fatigue interferes with everyday functioning but,     unfortunately, little is known about its mechanisms. The investigators propose a     characteristic eye movement abnormality (internuclear ophthalmoparesis, INO), commonly     encountered in MS, as a simple model for primary motor fatigue. The investigators described     worsening of ocular performance in MS patients with INO following visual tasks (ocular motor     fatigue), which is likely due to decreased neural conduction along brain pathways injured by     MS. This mechanism could represent a major component of MS-related primary motor fatigue.     Relevant to Veterans' care, INO is a significant cause of visual disability, especially when     complicated by ocular fatigue, and limits daily activities such as reading and driving. The     investigators propose a medical treatment to improve ocular performance/fatigue in INO, which     can reduce visual disability and improve quality of life in Veterans with MS.   "
68286|NCT02391948|"     The On Track Study is a large multi-site collaboration involving researchers, therapists,     families, and children with cerebral palsy (CP) from across Canada and the United States. The     researchers need to better understand how young children who have difficulties with movement     activities progress and develop in their balance abilities, fitness, strength, health, range     of motion, self-care, everyday play, and activity participation.      This study will determine how young children with cerebral palsy or gross motor delays     progress in many aspects of their physical development and participation in daily life. The     information collected from this study will help therapists and parents monitor if a child is     developing as expected in his or her physical development and participation. Then, the health     care professionals working with children can use the results of this study, in combination     with the previously completed Move & PLAY study results, to provide the services that are     most beneficial and meaningful for each child and their family members.   "
68357|NCT02391012|"     Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy     intestine as a probiotic preparation. The feces of a healthy individual is fluidized and than     inserted into the intestinal tract of a sick individual, assuming that the healthy flora will     colonize and cure the intestine. There are reports of the efficacy of this treatment for     inflammatory bowel disease but currently the numbers are small.      aim: To investigate whether use of FMT will bring improvement for colitis in IBD patients .     Methods: The patients will undergo full colonoscopy, the stool preparation will be infused     through the colonoscope during withdrawal of the instrument.   "
71312|NCT02352324|"     The main goal of our study is to assess the accuracy and reproducibility of continuous     beat-to-beat cardiac output (CO) measurement using pulse wave transit time in patients     undergoing off-pump coronary artery bypass grafting.   "
68287|NCT02391935|"     The primary purpose of this study is to assess the safety profile of RCS-01 injections as     compared to placebo injections. This study will also measure the impact these injections will     have on skin markers related to aging through evaluation of gene expression profiles.      30 participants will be selected for this study based on their health status, current/past     medications, and ability to adhere to protocol-related requirements. At the first visit and     after providing informed consent, participants are evaluated against the study     inclusion/exclusion criteria and provide blood samples for screening assessments (including     virology). If suitable for study participation, participants will provide a biopsy from the     scalp from which RCS-01 will be prepared and will have four treatment evaluation sites     identified on their buttocks, two on each side.      Study participants will be randomized to one of two treatment subgroups. Participants in the     RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a     needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n=     6) will be randomized to receive only injections of placebo or sham injections.      Baseline evaluations of subjects' overall health and skin condition at treatment sites on     their buttocks will be performed before receipt of injections at Day 0. In addition to     injections delivered at Day 0, the pre-selected treatment evaluation sites will receive     intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and     eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3)     injections per treatment site.      All participants will return to the clinic for at least 9 visits during the 52-week follow-up     period to monitor long-term safety. At the 12-week time point, 18 randomly-selected     participants from the RCS-01 Subgroup will provide biopsies from all injection sites for     analysis of skin markers related to aging. At the 26-week time point, the remaining     participants will provide biopsies of all injection sites for histopathological analysis.   "
68288|NCT02391922|"     The study evaluates the effect of a first aid course on first aid skills compared to no     training. The study also evaluates the effect of first-aid instructions given by emergency     dispatch central over mobile phone on first aid performance to no instructions.      Half the participants will perform first aid in two scenarios prior to first aid training.     Half the participants will perform first aid in two scenarios 4 to 5 months after attending a     first aid course. Half the participants (overall) will receive first aid instructions by     mobile phone during the scenarios.   "
68289|NCT02391909|"     This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in     healthy adult male and female travelers for whom typhoid vaccination with Vivotif is     recommended, as per standard practice.   "
68290|NCT02391896|"     Computed tomography (CT) is the most accurate test for evaluating patients with thoracic     disease. However, access to CT is limited due to long wait times and for the sickest patients     in Hospital who cannot be transported from the ward to the CT scanner. The investigators     propose to modify a standard X-ray unit to provide more detailed information of the chest     such that a CT scan is not required for all patients.   "
68291|NCT02391883|"     Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual     Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the     dilemma of putting the patient at risk of a major blood loss during and after surgery, or     putting the patient at risk of a thromboembolic event after surgery. The investigators     hypothesize that the risk of a major blood loss in patients that are still under the effect     of Clopidogrel or DAPT during or after hip-fracture surgery is relatively low. The     investigators have conducted a retrospective observational study on hip-fracture patients to     test this hypothesis.   "
68292|NCT02391870|"     Pregnant women with histories of depression are at high risk of depressive relapse during the     perinatal period, and options for relapse prevention are limited. Mindfulness-based cognitive     therapy (MBCT) has strong evidence among general populations but has not been studied among     at risk pregnant women.      This study is the first phase of a multi-phase project adapting MBCT for perinatal women     (MBCT-PD). It is being conducted in a collaboration between the University of Colorado, Emory     University, and Kaiser Permanente at Colorado and Georgia.   "
68293|NCT02391857|"     This study aimed to identify the effect of early gastric decompression on the improvement of     circulation in arrest patients during cardiopulmonary resuscitation at the clinical setting     of emergency department.   "
68294|NCT02391844|"     This is a pilot trial using this product in patients for the management of pain after     outpatient arthroscopic knee surgery. This is an open-label study and the two active     ingredients are well known pharmacologic entities.   "
68295|NCT02391831|"     NatHis-SMA is a prospective, longitudinal and interventional study of the natural history of     patients with type 2 and 3 Spinal Muscular Atrophy (SMA). The purpose of this study is to     characterize the disease course over 2 years and identify prognostic variables of the disease     and biomarkers of SMA progression, as well as determine the best outcome measures for further     therapeutics approaches.   "
68296|NCT02391818|"     The purpose of this study is to quantify the balance impairments during and after taxane     chemotherapy. Disability due to balance impairments caused by chemotherapy induced peripheral     neuropathy (CIPN) can cause falls, injury, and a decline in independence. This results in     poor treatment outcomes such as greater morbidity and mortality, inability to complete     treatment protocols, self-limitation of activity, and diminished quality of life.   "
68297|NCT02391805|"     This randomized, multicenter, partially double-blind, placebo-controlled study is designed to     evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects     of treatment with RO6864018 in virologically suppressed participants with chronic HBV     infection.   "
68298|NCT02391792|"     Microparticules (MPs) result from plasma cell membrane remodeling and shedding after cell     stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with     merging role in pathophysiology of immune and cardiovascular diseases. MPs have been     characterized during septic shock and may contribute to dissemination of pro-inflammatory and     procoagulant mediators. This a prospective observational study of circulating MPs and blood     coagulation in septic shock patients admitted in medical intensive care units (ICUs) of four     tertiary hospitals at baseline (D1, D2, D3, D4, D7).   "
68307|NCT02391675|"     The Hasselt Appendicitis Immunology and Environmental Study (HAPPIEST) aims at characterizing     factors that influence the development and severity of acute appendicitis. In a cohort of 300     patients and 300 controls, environmental factors as well as genetic make-up of the innate     immune system, focusing mainly on pattern recognition, will be analyzed in order to gain     insight in their relative importance in the pathology of appendicitis. Furthermore,     populations of micro-organisms present in the gut of patients will be characterized, and the     interaction between relevant micro-organisms and the innate immune system will be analyzed.   "
68348|NCT02391129|"     The purpose of this study was to compare the clinical (range of motion, weight bearing,     quality of life) and radiographic outcome (boney consolidation) between open reduction and     internal fixation using locking compression plates with revision prosthesis using a     non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C     periprosthetic fracture after primary total hip replacement.   "
68299|NCT02391779|"     Current recommendations today suggest that use of therapeutic lifestyle changes, such as     supplementation with specific dietary components and moderate exercise, are appropriate     interventions for individuals with borderline high blood pressure. Dietary intervention with     natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular     disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed to mediate the     cardiovascular health benefits following flaxseed consumption (Peterson 2010). Clinical     trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax® from Archer Daniels     Midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing     blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure (Cornish 2009).     Furthermore, a recent study in atherosclerosis patients showed significant clinical benefit     of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a therapeutic     lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the     effectiveness of FLC supplementation alone or in combination with moderate exercise merits     investigation.   "
68300|NCT02391766|"     After diagnosis of a dementing illness, patients and their spouses have many concerns related     to the disease and their future. This often leads to poor psychological well-being and     reduced health-related quality of life (HRQoL) of the family. Support for Empowerment has     been proven to be an effective method to improve prognosis of asthma, heart failure,     osteoarthritis.and diabetes. However empowering interventions have not been studied in     dementia. Therefore, the investigators aim was to examine, in an objective-oriented group     intervention, the efficacy of empowerment support program (ESP) on the HRQoL of dementia     patients and their spousal caregivers as well as on the sense of competence and psychological     well-being of caregivers.      Methods: During the years 2014 to 15, 180 dementia patients and their spouses will be     recruited from memory clinics or day centers and randomized into two arms: 90 patients for     group-based ESP sessions including topics selected by the participants and the use of the by     us for us guides, 90 patients will serve as controls in usual community care. Sessions may     include topics on dementia, active lifestyle and prevention for cognitive decline, spousal     relationship, future planning and emotional well-being. The patients and spouses will have     their separate group sessions (ten participants per group) once a week for eight weeks.   "
68301|NCT02391753|"     The aim of the study was the define changes LAM morphology, biometric measurements of the LAM     and genital hiatus at immediate evaluation of pelvic floor and at 3 month after delivery was     evaluated. We also sought to define the optimal time for evaluation of pelvic floor after     childbirth   "
68302|NCT02391740|"     Describe the expectations of therapeutic education for patients in management of cancer pain.   "
68303|NCT02391727|"     A first-in-human evaluation of SYN004, a monoclonal antibody that binds to the EGF receptor     on cancer cells. Cetuximab, a marketed antibody, has been shown to be effective by inhibiting     the growth of cancer cells thereby prolonging the life of patients who have received it.     SYN004 is a closely related monoclonal antibody also binds to the EGF receptor in the same     way. SYN004 might also inhibit cancer cells and prolong life but has been engineered to avoid     some of the hypersensitivity reactions known to provoked by cetuximab.   "
68304|NCT02391714|"     The purpose of this study is to determine whether Nitrous Oxide is effective in achieving     pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).   "
68305|NCT02391701|"     BACKGROUND:      The Southern European Atlantic Diet (SEAD) is the traditional diet of Northern Portugal and     Galicia, a region in northwest Spain. The SEAD has been associated with a lower risk of     non-fatal acute myocardial infarction. Possible mechanisms of this association may be related     with a lower concentration of markers of inflammation and with reduced triglycerides,     insulin, insulin resistance, and systolic blood pressure.      Aim: To evaluate the effect of an Atlantic Diet on i) lipid profile, ii) markers of     inflammation, and iii) anthropometric indices in a population-based study      METHODS:      This is a non-pharmacological clinical trial study which is performed on a family-oriented     basis. 250 families (~ 750 children and adults, older than 3 years) were selected to     participate in the study and randomized into Atlantic Diet (AD) (n=125 families) and control     (n=125 families) groups. The AD groups participate in a diet program 1 day a month for 3     months in 120-minute diet sessions and freely receive AD food, characterized by a high intake     of vegetables, cheese, olive oil, mussels and by wine consumption during meals. Control group     subjects do not participate in any regular diet activity during this period and did not     receive additional food. Exclusion criteria are alcoholism, lipid treatment, dementia, and     terminal disease.      Weight, BMI, waist circumference (WC), skin folds, nutrient intake from 3-day recalls, food     frequency questionnaire, physical activity, blood pressure, metabolic function (fasting blood     glucose, HBA1c, insulin resistance and lipid profile), and inflammation markers (c-reactive     protein, interleukin 6 and tumor necrosis factor-alpha) are measured at baseline, 3 and 6     months. Mixed effect models will be performed to assess the significance of changes in the     cardiometabolic parameters.      The primary end point is the change in lipid profile compared with baseline and the control     group arm at the end of Month 6. The secondary exploratory end points were change in     anthropometric indices and inflammation markers at Month 6.   "
68306|NCT02391688|"     Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and     transporters in vivo. It consists of the administration of probe substances metabolised by a     specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the     determination of a metabolic ratio or the evaluation of the plasmatic or urinary     concentrations of the probe substances. The administration of a cocktail containing several     probe substances allows the simultaneous evaluation of the activity of several cytochromes     and P-gp in a single test.      When a cocktail approach is used it is important to make sure that no drug-drug interactions     occur between the probes within the cocktail. The validation of the lack of interactions,     which is the aim of the study, consists of demonstrating that there is no difference in the     pharmacokinetic parameters and/or metabolic ratios when a probe is administered alone or as     part of the cocktail. The Geneva cocktail consists of caffeine, bupropion, flurbiprofen,     omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of     CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.      Probe and metabolite concentrations will be measured in capillary blood using a dried blood     spot (DBS) analysis. To further facilitate sampling, a new simple device will be used to     ensure the precision of capillary blood collection.   "
68322|NCT02391467|"     Non invasive methods are the only available methods to stage liver fibrosis during pregnancy.     The safety of elastometry - ultrasound based - is obvious, as medical supervision of     pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this     method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis     infection, whereas its validity in pregnant women has never been studied. This lack of data     justifies our study.   "
68308|NCT02391662|"     Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer     is 1:3. Although many clinical trials include elderly patients, no results for this subgroup     of patients are available. Since there is no specific recommendations for treatment of     elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment of     choice for these patients.      Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and     targeted agents to gemcitabine has almost invariably provided no significant survival     improvement.      Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic     cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in     overall survival, but due to in this clinical trial was included patients between 27 and 88     years, it is considered necessary to conduct a specific study for patients over 70 years.      The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel     associated with gemcitabine can be extended to elderly patients with pancreatic cancer.   "
68309|NCT02391649|"     This proposed randomized controlled trial will test the effectiveness of a problem-solving     based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia spectrum     disorders. A repeated-measures, three-group design will be used to evaluate and compare the     effects between two treatment groups(PSBBP and psycho-education group) and routine outpatient     service and family support (control group) for 129 randomly selected family caregivers of     outpatients with schizophrenia-spectrum disorders over a 12-month follow-up.   "
68310|NCT02391636|"     Double blinded randomized controlled study   "
68311|NCT02391623|"     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     multiple oral doses of PF-06427878 in healthy adult subjects.   "
68312|NCT02391610|"     The China-Anhui Birth Cohort Study (C-ABCS) was set up to examine the delayed, cumulative and     interactive effects of maternal environmental exposures on birth outcomes and children's     development. The C-ABCS recruited pregnant women from six major cities of Anhui province,     China, between November 2008 and October 2010. A range of data (including demographic,     obstetric, occupational, nutritional and psychosocial factors) were collected by both     interviews and laboratory tests. In each trimester, women's blood samples were drawn, and     pregnancy complications were abstracted from physician's medical records. By the end of 2011,     birth outcomes/birth defects were observed/identified by clinicians within 12 months after     the delivery of 11 421 singleton live births of six cities and those outcomes among the     remaining 2033 live births are still being observed. In addition, 4668 children from     Ma'anshan city will be further followed up during the pre-school period till they reach     adolescence to obtain the data on familial environmental exposures as well as children's     physical, psychological, behavioural and sexual development. The interview data and     information on laboratory examinations are available on request from archives in the Anhui     Provincial Key Laboratory of Population Health & Aristogenics.   "
68313|NCT02391584|"     Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube     dilation.   "
68314|NCT02391571|"     This single-center study is a randomized, double-blind, active-controlled, multiple-dose,     parallel group study to evaluate the potential withdrawal effects, safety and tolerability,     and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact     Oxycodone/Naltrexone capsules compared to oxycodone in methadone-maintained opioid-dependent     subjects. The study will consist of a Screening Phase, an inpatient Treatment Phase     (including a methadone stabilization period, a placebo administration period, a treatment     administration period and a safety/washout period), and a Follow-up Phase.   "
68315|NCT02391558|"     Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace     fluorescein angiography.   "
68316|NCT02391545|"     A Two-arm, Phase 1b/2 Study of IPI-145 Administered in Combination with Rituximab or     Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.   "
68317|NCT02391532|"     The aim of this study is to investigate the effect of daily intake of the probiotic     Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in     nursery homes.   "
68319|NCT02391506|"     This study will evaluate whether Cartiva is an effective treatment for individuals with     osteoarthritis of the CMC joint in the hand.   "
68320|NCT02391493|"     For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping     studies have shown that different languages may be localized, at least partially, in distinct     microanatomical systems located within the same gross anatomical areas.      The present investigation involves both types of healthy bilinguals with carefully controlled     proficiency levels, as well as bilingual patients suffering from low-grade glioma.      Functional magnetic resonance imaging data will be collected while the participants perform a     picture naming task in blocked conditions for both languages (either English or French) or in     switch condition (English and French). A stimulation mapping study will be conducted in the     patients during awake surgery with the same tasks.   "
68321|NCT02391480|"     This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid     tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2     dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will     evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or     combination therapy in disease specific expansion cohorts.   "
68353|NCT02391064|"     Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly     information processing speed (IPS) which also influences with other cognitive functions such     as attention, working memory and executive functions. The investigators validated a     computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect     disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for     multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT),     a test of the IPS, and two measures of episodic memory. On the same principle, the     investigators propose to validate a short computerized battery to improve the feasibility     (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test     of visual episodic memory.      Purpose: to establish the screening value of a brief computerized cognitive assessment     (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized     episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as     compared to a reference battery (MACFIMS).   "
68323|NCT02391454|"     Rationale: Cancer treatment is increasingly successful, resulting in a rising number of     cancer survivors. A substantial number of survivors may experience long-term and late side     effects from their cancer treatment. In addition, evidence is accumulating that an active     lifestyle positively influences cancer treatment outcome and changes the recurrence rates of     the disease. Therefore, physical activity (PA) programs are urgently needed and should be     incorporated in current treatment regimens. It is noted though that cancer patients and     survivors experience difficulties in remaining physically active. A 'smartphone application'     (app) may be an accessible way to counteract these problems. The app 'RunKeeper', founded by     Mr. Jason Jacobs, 2008, FitnessKeeper Inc. (RunKeeper) is a free, widely spread and     well-known app for self-monitoring PA. Convenient features of RunKeeper are self-monitoring     PA with GPS or stopwatch, recording progress, goal setting, and personal records. In this     study the investigators aim to determine if the RunKeeper app use improves PA by     self-monitoring and empowering PA during or after cancer treatment in comparison with usual     care in a 12-week follow-up.      Objective: The primary objective is to identify an improvement in PA as measured by the PASE     questionnaire when using the RunKeeper app in comparison with usual care for 12 weeks during     or after cancer treatment. The investigators hypothesize that the RunKeeper app might assist     in stimulating and improving PA behavior. Secondary objectives are to explore the usability     of the RunKeeper app.      Study design: The present study is a single-centre prospective two-armed randomized     controlled feasibility study.      Study population: Adult patients diagnosed with cancer currently being treated or under     surveillance at the department of Medical Oncology at the UMCG.      Intervention: Patients who give informed consent will be randomized in one of the two study     arms; 'Group A', usual care (N=15) or 'Group B', usual care + the RunKeeper app (N=15).     Directly after randomization, Group B will be sent a brief user's manual for RunKeeper and     requested to install the RunKeeper app. Group B will use the RunKeeper app for 12 weeks to     self-monitor PA.      Main study parameters/endpoints: The primary endpoint is to calculate the effect-size of the     RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the Physical     Activity Scale for the Elderly (PASE) questionnaire. The investigators hypothesize that the     RunKeeper app might assist in stimulating and improving PA behavior.   "
68324|NCT02391441|"     The investigators will evaluate ventricular reversed remodelling after double lung     transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with     cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control     patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.   "
68325|NCT02391428|"     Attention deficit hyperactivity disorder (ADHD) is a major problem in children and     adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated     fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with     important physiologically active functions.      Aim: Study the relationship between omega3 blood values and ADHD clinical status.      Methods: The investigators will recruit 30 children, who have been diagnosed with ADHD by a     child psychiatrist. In addition the investigators will recruit a control group of 30 children     without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children.      The ADHD children will be asked to consume omega3 capsules for 6 month. After 3 and 6 months,     all children will undergo clinical examination and blood tests will be taken for omega3 index     analysis. Blind frozen samples of isolated red blood cell (RBC) will be analyzed according to     the omega3 index methodology.   "
68326|NCT02391415|"     Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease     C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated     and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons     at risk in non-endemic areas. The new vaccine should be at least as potent as the current     strain and should be safer than BCG.      The preceding phase-IIa trial was the first investigation of VPM1002 in newborn infants in a     high burden setting in South Africa. The vaccination of HIV-unexposed infants with VPM1002     indicated again safety, tolerability and immunogenicity sufficient to proceed in HIV-exposed     infants.      The current study is a multiple site trial in South Africa to evaluate safety and     immunogenicity in HIV-unexposed and -exposed newborn infants.   "
68327|NCT02391402|"     The primary objective of this study is to evaluate the efficacy of Cognitively Augmented     Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid     mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's     specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with     mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with     mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and     quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for     Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized     treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health     Administration (VHA) treatment settings.   "
68328|NCT02391389|"     Delayed clamping of the umbilical cord (DCC) has been shown to have some benefits for preterm     infants. Initiation of breathing before cord clamping is also thought to be beneficial. Since     some preterm infants do not breathe well on their own immediately after birth, assisting     ventilation during delayed cord clamping might have additional benefit beyond DCC alone.     VentFirst Pilot will assess feasibility and safety of assisting ventilation of preterm     infants during 90 seconds of DCC which is essential before proceeding to a randomized     clinical trial.   "
68329|NCT02391376|"     The purpose of this study is to compare the effects generated by the application of three     different packs on the flexibility of the lower back of sedentary students. Method: Three     sessions of 15 minutes of superficial heat through a hot pack (moist heat pack-MHP, seed     pack-SP or gel pack-GP) were applied on the lower back. Pack and lower back temperatures and     erythema were registered every 5 minutes. Schober test was performed before first session and     after the third session.   "
68330|NCT02391363|"     The purpose of this research study is to see how helpful two different interventions offered     through the Calmer Life program are in reducing worry and improving mood. The investigators     also want to understand how a program like Calmer Life can be offered in underserved     communities.   "
68331|NCT02391350|"     Low back pain and sciatica is a common condition resulting in high costs and disability for     society and affected individuals. Presently there is a lack of evidence for what treatments     may help this condition early in the course of care. Improved early management could reduce     risks for persistent disability and high costs. The goal of this project is to examine the     clinical outcomes and costs associated with adding a physical therapy program to early     management of patients with low back pain and sciatica within primary care.   "
68342|NCT02391207|"     Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the     caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study     aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative     ultrasonography (IOUS) in a cohort of patients having at least one colorectal liver     metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large majority     of cases thanking to CLMs detachment or to HV partial resection or reconstruction: this     policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically     provides an adequate local control.   "
68332|NCT02391337|"     Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for     patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in     death. The number of patients with this condition are expected to double in the next 20     years. Medications to control heart-rate are used in the majority of patients, although the     choice of agent is often guided by local preference rather than evidence from controlled     trials. Despite the fact that patients with atrial fibrillation have high rates of other     cardiac conditions such as heart failure, clinicians have insufficient evidence to     personalise the use of different therapies. This feasibility study will allow us to develop a     range of methods that can characterise patients according to the pumping and relaxing     function of the heart, the burden of symptoms and to identify new blood markers. In this way,     the investigators hope to improve clinical practice guidelines, allowing doctors to prescribe     appropriate treatments for the right patients.      The research will be focused around a randomised trial of two medication strategies,     providing much-needed data on the comparison of digoxin and beta-blockers (two commonly-used     drugs in patients with atrial fibrillation). It will also allow us to identify the best way     to record patient-reported quality of life and develop robust techniques to determine heart     function using non-invasive imaging, facilitating the conduct of a large-scale clinical     trial. The key objectives of the research programme are to define the optimal medications for     patients with atrial fibrillation and identify the most valid, reproducible and     cost-effective methods to examine patients. The ultimate aim of the project is to improve     clinical outcomes in atrial fibrillation, benefiting patients, the National Health Service     and the global community.   "
68333|NCT02391324|"     Robot assisted gait training is seen as a promising intervention for improving the walking     abilities of children with cerebral palsy, but research to support its effectiveness compared     to best practice physical therapy is lacking. This research consists of a randomized     controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The     goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device     (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance     balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a     combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular     maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18     years). The three intervention programs will consist of sixteen 50-minute sessions given     twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four     groups with respect to walking-related motor skills as measured by the Gross Motor Function     Measure. The secondary objectives are to compare each intervention's impact on walking     abilities, individualized goals, fitness, balance, physical activity levels, child's belief     in ability to do physical activity, participation and quality of life. The investigators will     also evaluate the extent of carryover or progress 3 months after the intervention. The     qualitative part of the study will consist of interviews of children and parents after they     have finished the study intervention. The information from the interviews will assist us with     interpretation of the outcome results (areas of impact and amount of change) from the RCT. In     particular, the interviews will 1) provide insight into their experiences with the trial     interventions, 2) identify the mobility-related outcomes that are important to families and     the factors that influence their preferences, and 3) explain the family values, experiences     and contextual factors that influenced participation in the study. This research will provide     information needed to allow clinicians and families to make informed choices about Lokomat     therapy and physical therapy options in relation to their child's functional goals and     abilities.   "
68334|NCT02391311|"     The goal of this study is to conduct a small, self-contained project to test the hypothesis     that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The     investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in     either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and     examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis 1:     The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP     CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate     generalization to secondary neurocognitive domains compared to the sham tDCS condition.   "
68335|NCT02391298|"     The aim of this study is to examine whether meditation delivered by the internet improves     mood and attention as well as increases levels of dopamine in individuals who have been     diagnosed with Multiple Sclerosis.   "
68336|NCT02391285|"     To assess the potential clinical utility of measuring pelvic floor muscle tone after     childbirth by vaginal dynamometry, the investigators will study 50 consecutive consenting     first attendees of the Jessop Wing perineal trauma clinic. In addition to clinical and     imaging assessment routinely offered women at this clinic, the investigators will measure     their active and passive pelvic floor muscle tone using the Auckland vaginal elastometer. The     investigators will also assess structural pelvic floor muscle damage (PFMD) in a subset of 10     women (5 symptomatic and 5 asymptomatic) by Magnetic Resonance Imaging (MR) scan of the     pelvic hiatus. The investigators will then determine the predictive capacity of vaginal     elastometry for symptoms of pelvic floor damage, findings of endoanal sonography, and MR     scans of the pelvic floor hiatus. The investigators will determine if vaginal elastometry can     prove an objective and accurate frontline assessment tool for the management of PFMD     following childbirth. Our observations will generate vital data for powering and designing a     large clinical trial evaluating the potential use of the vaginal elastometer as a first line     assessment tool of PFMD in the postnatal period. Data will also inform the design of a     personalised model for predicting and managing pelvic floor muscle damage during childbirth.   "
68337|NCT02391272|"     The project was undertaking by Qilu Hospital of Shandong University and other well-known     hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in     pregnancy.   "
68338|NCT02391259|"     This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising     single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing     cohorts   "
68339|NCT02391246|"     Gliomas are the most common malignant primary central nervous system (CNS) tumours. When     high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional     sequences is required.The Positron Emission Tomography (PET) radiotracer     [18F]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes seen     on MRI which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.   "
68340|NCT02391233|"     The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the     effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention     (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other     sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as     Black) women drug users in probation sites in New York City (NYC), compared to streamlined     HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post     intervention. The primary outcomes will be to reduce cumulative incidence of biologically     confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex     acts.   "
68341|NCT02391220|"     This study evaluates the effect of a symbiotic fermented milk on health-related quality of     life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant     IBS.   "
68343|NCT02391194|"     This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent     breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.   "
68358|NCT02390999|"     3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic     hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest     patients. The investigators are challenged in our attempt to predict outcome of these     patients by both low body temperature in itself and the sedative and relaxing drugs used to     keep the patient in a coma.      This study is a substudy in a large international multicenter randomized trial that     investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays     standard of 24 hours.      In this substudy the investigators will approach early prediction of neurological outcome     using a combination of new examinations backed up by well established ones to engage this     challenge from different angles and find a battery of combined examinations, that together     will enable us to accurately predict outcome at an earlier stage.      Our examinations have been chosen from the three fields of neurophysiology, biochemistry and     neurology and consist of electroencephalography (EEG), somatosensory evoked potentials (SEP),     biomarkers and clinical examinations such as brain stem reflexes chosen for their prognostic     reliability.   "
68359|NCT02390986|"     The purpose of this clinical trial is to evaluate the long term safety and efficacy of     LON002.   "
68360|NCT02390973|"     Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The     mechanisms underlying type 2 diabetes remission and others metabolic improvements after     Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with     duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a     longitudinal study with the overall objective of measuring the long-term impact of these     three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in     patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric     procedures generate hitherto unrecognized effects on many disease-related outcomes, which     greatly contributes to their beneficial impact in diabetic patients. The investigators     propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the     metabolic recovery and quality of life in groups of diabetic patients treated with insulin,     hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on     renal and cardiovascular functions in subgroup of patients with these conditions; 3) to     compare metabolic impact of surgeries to those of best medical care for diabetes in a     non-surgical control group. For most severely obese patients, lifestyle interventions,     perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight     loss maintenance and durable metabolic recovery. The increasing popularity of obesity     surgeries calls for a better understanding of the underlying mechanisms. This is especially     true and urgent when considering that knowledge on the relative impact of each procedure     (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of     the procedures will allow stronger scientific rationale for selecting the right surgery for     the right patient and improve care for the severely obese individual.   "
68361|NCT02390960|"     This is a Phase 2a, single-dose, double-blind, placebo-controlled, 2-way crossover study in     men with ED. A single 2 gram dose of SST-6006 topical cream 5% w/w (formulated to deliver 100     mg of sildenafil) or a topical placebo cream will be applied to the penile shaft and glans.     There are 4 study phases: the Initial Patient Screening Phase (Visit 1, an Off Site 4-Week     Run-in Period and Visit 2), the Final Patient Screening Phase (Visit 3), the SST-6006/Placebo     Double-Blind Dosing Phase (Visits 4-5), and the Follow-up Phase. Primary outcomes will be be     evaluated at Weeks 7 and 8 of the study   "
68362|NCT02390947|"     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and     Flt3, whose anti-tumor and anti-angiogenesis effects have been validated in preclinical     tests. In PhaseⅡb study, a significantly improved Progression Free Survival (PFS) was found     in patients with advanced colorectal cancer treated with Famitinib compared to placebo. On     the other hand, the toxicity of Famitinib was manageable in both PhaseⅠand Ⅱb studies.      The purpose of this study is to determine whether Famitinib can improve Overall Survival (OS)     compared with placebo in total 540 patients with advanced colorectal cancer who have failed     in previously received at least two lines of standard chemotherapy.   "
68363|NCT02390934|"     The purpose of this Phase II single-arm study is to evaluate the efficacy of Radium-223 in     treating bone lesions from differentiated thyroid cancer that are I-131 refractory. Based on     the results of the phase III trial, the protocol using an injection of Radium-223 activity of     50 kBq/kg b.w. given 6 times at 4 weeks interval will be applied. The end point of this study     will be the evaluation of Radium-223 efficacy one month after 3 administrations, i.e. at 3     months after the first injection. If disease progression at that time is excluded, patients     will be treated with 3 further injections for a total of 6 administrations of Radium-223. The     principal response criterion at 3 and 6 months will be the metabolic response on FDG PET/CT,     but other imaging techniques will also be performed: axial skeleton MRI, 99mTc-HMDP bone scan     and FNa PET/CT. Axial skeleton MRI is the reference for soft tissue study. 99mTc- HMDP bone     scan is the most used and available routine tool to detect bone metastases in cancer     patients, but its sensitivity in patients with bone metastases from thyroid cancer is low,     because most lesions are lytic [23]. 18FNa PET/CT shows higher sensitivity than 99mTc-HMDP     bone scan to detect bone lesions in cancer patients and is able to detect micrometastases     that are not seen on bone scan [24] [25]. Preliminary results show some interest of using     this tracer to evaluate the sclerotic component of bone metastases from thyroid cancer [26].     Furthermore preliminary data show that FNa PET/CT can be useful to quantify response to     Radium-223 in prostate cancer. In only five patients evaluated by FNa PET/CT at baseline, 6     weeks and 12 weeks after 100 KBq/Kg of Radium-223, semiquantitative analysis by SUV max     showed a relationship between PSA and SUV max level decrease in 3 patients (-44%, -31%, -27%     vs -52%, -75, and -49% respectively) [27].      Finally bone metastases that are visible on morphological imaging (CT scan or on RI) are     frequently submitted to local treatment modalities, and this may induce fibrosis and     recalcification. Therefore, already treated metastases and not treated metastases will be     studied separately as two separate subgroups of target lesions.   "
68364|NCT02390921|"     Bariatric surgery is the most effective long-term treatment of morbid obesity treatment, so     you can maintain weight loss enduringly with improvement or resolution of comorbidity and     mortality reduction. All bariatric surgery techniques in postoperative induce a significant     reduction in food intake and / or absorption of nutrients and therefore may be associated     with a risk of nutritional deficiency, which increases over the years after surgery. One of     the nutrients whose absorption is affected significantly is iron, women of childbearing age     segment most vulnerable being. A significant percentage of these women require oral     supplementation with high doses of iron and often parenteral treatment is needed for     digestive intolerance or therapeutic failure.      Hypothesis: The liposome orally administered iron could represent a therapeutic alternative     in women of childbearing age, previously undergone bariatric surgery that currently require     parenteral iron therapy.      Objectives: To evaluate the tolerability and efficacy of oral iron liposome female patients     previously undergone bariatric surgery that currently require parenteral replacement therapy,     as well as the impact on quality of life.      Methods: a single center, open, prospective, interventional, in 40 women of childbearing age,     previously undergone bariatric surgery, which currently require intravenous iron therapy     chronically. Subjects will be divided into 2 parallel groups: 20 cases and 20 controls     matched for age, level of Hb, year after surgery and percentage of weight lost.      Relevance: This study will allow us to identify an alternative treatment with oral iron in     the case of patients with severe iron deficiency after bariatric surgery, which currently     require parenteral iron therapy due to intolerance to current oral products or therapeutic     failure. At the same time it could help reduce healthcare costs and improve the quality of     life of these patients, who will not have to enter periodically in solitary day hospital for     administration of parenteral iron.   "
68391|NCT02390570|"     This study is designed to answer why patient capacity (i.e. patient available abilities and     resources to enact self-care and access healthcare) is not regularly documented in the     Electronic Medical Record (EMR) in a way that is useful for clinicians.      Through the implementation of communication tools designed for patient capacity assessment     and engagement of stakeholders in a process of user-centered design, the study team     hypothesizes that the study can help clinicians elicit this information in conversation and     regularly document it in the medical record for future healthcare discussions.   "
68365|NCT02390908|"     Alcohol use is increasingly recognized as a key factor in morbidity and mortality among     HIV-positive individuals and represents an important public health concern, given its     associations with medication non-adherence, increases in viral load, poor immunologic     outcomes (lower CD4 counts), drug resistance, lower health care utilization, comorbidities     (HIV/viral hepatitis coinfection), and poor health outcomes overall. Adherence to HIV     medications has a double public health benefit, both in terms of slowing disease progression     and improving health outcomes among HIV-positive individuals and in helping to curb the     sexual transmission of HIV. The objective of this study is to implement a multisite     comparative effectiveness trial in real-world clinical settings with three intensities of     treatment to test the clinical and cost effectiveness of an efficacious, theory-based     behavioral intervention (PLUS) in improving ART-adherence and alcohol-related outcomes among     HIV-positive individuals who drink alcohol at harmful or hazardous levels. The study is being     conducted in collaboration between the Center for HIV Educational Studies and Training     (CHEST) at Hunter College, CUNY and the Spencer Cox Center for Health at the Institute for     Advanced Medicine, Mount Sinai Health System.   "
68366|NCT02390895|"     The purpose of this study is to determine the feasibility of prenatal minimally-invasive     fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under     amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with     one patch or the suture of the skin edges by stitch   "
68367|NCT02390882|"     The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412     and HIP1402 in patients with Benign Prostatic Hyperplasia   "
68368|NCT02390869|"     A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of     Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after induction's     chemoimmunotherapy with Rituximab-Bendamustine for relapsed/refractory FL patients not     eligible for autologous transplantation (ASCT).   "
68369|NCT02390856|"     Open reduction and internal fixation (ORIF) of unstable distal radius fractures is performed     using a variety of fixation techniques. The most common method is fixed angle volar plate     application. The investigators plan to compare the outcomes of fixed angle volar plating with     a novel FDA approved intramedullary fixation device, Conventus DRS.   "
68370|NCT02390843|"     This is a Phase I trial with new experimental drugs such as simvastatin in combination with     topotecan and cyclophosphamide in the hopes of finding a drug that may work against tumors     that have come back or that have not responded to standard therapy. This study will define     toxicity of high dose simvastatin in combination with topotecan and cyclophosphamide and     evaluate for cholesterol levels and IL6/STAT3 pathway changes as biomarkers of patient     response.   "
68407|NCT02390362|"     We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than     MMF in maintaining remission in children with frequent relapsing or steroid dependent     nephrotic syndrome who have had one relapse while receiving MMF.      We will conduct a randomized study comparing two Rituximab infusions and continued MMF     treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).   "
68408|NCT02390349|"     This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and     Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will     receive Curamin and one group will receive placebo.   "
68371|NCT02390830|"     Background. Balance disorders and falls are common in People with Multiple Sclerosis (PwMS)     Objective: Our hypothesis was that PwMS treated for balance disorders would reduce balance     disorders and frequency of falls.      Methods: A bi-centre randomised Rater-blinded controlled trial. Participants in both groups     received 20 treatment sessions. Participants in the intervention group received treatment     aimed at improving control of the position and movement of the centre of mass and body     segments. Participants in the control group received treatments to reduce limitations at     activity and body function level.      Group allocation was done by an independent clinician by a randomization list made before the     beginning of the study. Group allocation was kept concealed throughout the study and     participants were not aware of group assignment.      Data was analyzed according to a preplanned protocol by using an intention to treat approach.   "
68372|NCT02390817|"     The study will be performed to evaluate motor response and awareness with using sugammadex     during wakeup procedure in spine surgery. The investigator's goal is to investigate the     effect of sugammadex on the state of consciousness and motor-somatosensorial evoked     potentials.   "
68373|NCT02390804|"     The objective of this study is to compare postoperative pain between single-port access total     laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and     conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A     prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign     gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and     postoperative pain and operative outcomes were examined.   "
68374|NCT02390791|"     Cluster randomized controlled trial to evaluate the general effectiveness of intervention     compared to control on medication continuity as measured by prescriptions written and other     more proximal outcomes during the first six months of treatment.   "
68375|NCT02390778|"     The objectives of the study were: To (1) describe the epidemiology of emotional distress     experienced by Ugandan violence researchers; to (2) assess the effectiveness of group     debriefings in mitigating secondary distress; to (3) assess risk and protective factors.     Eligible participants were 59 Ugandan researchers employed by the Good Schools Study (GSS,     NCT01678846) to interview children and adults who experienced violence. Recruited     participants were randomly assigned to group debriefings (intervention) or film viewing     (control). The primary outcome was change in levels of emotional distress.   "
68392|NCT02390557|"     No standard way exists to measure the quality of medical care or independent living long-term     services and supports provided to persons with disabilities. This project will: provide a     broader picture of how consumers with disabilities define care and care quality; measure the     value of using consumers' expertise in developing, collecting, and assessing quality     measures; and use this information to assist One Care providers in improving care delivered     to their enrollees   "
77140|NCT02276144|"     The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function     abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk     of pregnancy complications.   "
68376|NCT02390765|"     Background:      - Studies show that many factors affect children s eating behavior and health. These include     sleep, mood, thinking skills, and genetics. Studying children over time may identify children     at higher risk for eating-related health concerns.      Objective:      - To understand how genes and environment influence eating behavior and health over time.      Eligibility:      - Children ages 8 17 in good general health.      Design:        -  Screening visit 1: Medical history, physical exam, body measurements, and questions.        -  14 days: Participants will wear a wrist monitor and answer smartphone prompts about          eating and mood. They may give a stool sample.        -  Screening visit 2:        -  Body measurements.        -  Saliva, urine, and blood samples.        -  Heart tests.        -  Meals provided (after fasting overnight).        -  Questionnaires and interview.        -  Behavior, thinking, and exercise tests.        -  X-ray of left wrist and full body.<TAB>        -  Some parents may have medical history, physical exam, and questions at screening visits.          They may answer questions at the yearly visits.        -  Participants will have up to 6 yearly visits. They will give a urine sample and body          measurements, and repeat the X-rays. They will have questions and behavior and thinking          tasks. They may give stool samples. Visits will range from 3 to 8 hours.        -  Participants may choose to participate in other studies:        -  Stress and Hormones, 1 visit: While resting, participants will give saliva samples and          have their heart monitored. Then they will do math. They will repeat the resting part,          then do a computer task.        -  Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on          their head then answer questions. Once, they will have an MRI, lying still in a scanner          with a coil on their head.        -  Sleep, 2 visits: Participants will have food provided, answer questions and do tasks.      Participants will be compensated for the time and inconvenience involved with completing     study procedures.   "
68377|NCT02390752|"     Background:      - Some people with cancer have solid tumors. Others have refractory leukemia. This doesn t go     away after treatment. Researchers want to see if a drug called PLX3397 can shrink tumors or     stop them from growing.      Objectives:      - To find the highest safe dose and side effects of PLX3397. To see if it helps treat certain     types of cancer.      Eligibility:        -  People ages 3 22 with a solid tumor or leukemia that has returned or not responded to          cancer therapies.        -  For Phase II, people ages 3 31 with a Neurofibromatosis Type 1 (NF1) Associated          Plexiform Neurofibroma (PN) that cannot be removed with surgery.      Design:        -  Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Heart tests        -  Scans or other tests of the tumor        -  Participants will take PLX3397 as a capsule once daily for a 28-day cycle. They can do          this for up to 2 years.        -  During the study, participants will have many tests and procedures. They include repeats          of the screening tests. Participants will keep a diary of symptoms.        -  Participants with solid tumors will have scans or x-rays.        -  Participants with NF1 PN will have MRI scans.        -  Participants with leukemia will have blood tests. They may have a bone marrow sample          taken.        -  Some participants may have a biopsy.        -  When finished taking PLX3397, participants will have follow-up visits. They will repeat          the screening tests and note side effects.        -  Phase II will follow the same procedures as Phase I above, but participants will also          fill out questionnaires about their pain and quality of life.   "
68378|NCT02390739|"     Background      The NCI Surgery Branch has developed an experimental therapy for treating patient with     metastatic thyroid cancer that involves taking white blood cells from the patient, growing     them in the laboratory in large numbers, genetically modifying these specific cells with a     type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to     the patient. This type of therapy is called gene transfer. In this protocol, we are modifying     the patient s white blood cells with a retrovirus that has the gene for anti-thyroglobulin     incorporated in the retrovirus.      Objectives:      The purpose of this study is to see if these tumor fighting cells (genetically modified     cells) that express the receptor for the thyroglobulin molecule on their surface can cause     thyroid tumors to shrink and to see if this treatment is safe.      Eligibility:      <TAB>Adults 18 and older with thyroid cancer that has the thyroglobulin molecule on tumor     surfaces      Design:      <TAB>Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and     undergo a history and physical examination, scans, x-rays, lab tests, and other tests as     needed      <TAB>Leukapheresis: If the patients meet all of the requirements for the study they will     undergo leukapheresis to obtain white blood cells to make the anti- thyroglobulin cells.     {Leukapheresis is a common procedure, which removes only the white blood cells from the     patient.}      <TAB>Treatment: Once their cells have grown, the patients will be admitted to the hospital     for the conditioning chemotherapy, the anti-thyroglobulin cells and aldesleukin. They will     stay in the hospital for about 4 weeks for the treatment.      Follow up:      Patients will return to the clinic for a physical exam, review of side effects, lab tests,     and scans about every 1-3 months for the first year, and then every 6 months to 1 year as     long as their tumors are shrinking. Follow up visits take up to 2 days.   "
68423|NCT02390154|"     The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the     body in a so called mass-balance study. This means to investigate how the study drug is     absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from     the body.   "
68379|NCT02390726|"     The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant     (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the     expanding choices of medication for UC, physicians and patients are still in search of highly     effective and safe medications with minimal side effects. FMT has been approved for the     treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has     been proven to be an effective and safe alternative therapy with zero reported serious     adverse events from patients that have had this treatment.      The providers that are conducting this study hypothesize that delivering microbes from a     healthy human gut can help treat the damages caused by UC. This is done by transplanting     fecal material, which contains a highly complex and dense community of healthy microbes,     including bacteria, fungi and viruses. This collection of microbes is referred to as a     microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.   "
68380|NCT02390713|"     This ring aimed to preserve an intra-hepatic porto-caval gradient inferior to 5 mm Hg during     and after major hepatectomy (48h) to protect the liver during the initial phases of liver     regeneration. Morphological features of MID-AVRTM allow its intra corporeal opening and     percutaneously removal after an balloon inflation with 5 ml of physiological serum. MID-AVRTM     had been developed in pig where it had proved its efficiency to improve liver function after     75% hepatectomy and its capacity to be removed percutaneously. Aim of this feasibility study     (Phase I/II) is to prove in series of 3 evaluable patients (Phase A) then 6 evaluable     patients (Phase B) that MID-AVRTM could be used in human without deleterious consequence. In     phase A, MID-AVRTM is dispose around the portal vein before and during a major hepatectomy     performed on healthy liver and removed before abdominal closure. If phase A results confirmed     that MID-AVRTM well modulates portal pressure and is easily opened and removed by acute     inflation, the phase B will be started. In phase B, MID-AVRTM will be dispose around the     portal vein before major hepatectomy on healthy liver and conserved 48 hours before to be     removed percutaneously at the operating room.   "
68381|NCT02390700|"     The purpose of this study is to evaluate the incidence and management of infusion reactions     with Golimumab intravenous infusion.   "
68437|NCT02389972|"     The primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML     patients in China in the real-world clinical practice setting.   "
68382|NCT02390687|"     Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory     response and alter the diversity of periodontal disease. In recent years, various     host-response modulation therapies have been developed to block the pathways responsible for     periodontal tissue breakdown.      There have been significant changes with respect to the effectiveness of, and attitudes     towards conventional antimicrobial therapy to combat disease. With the threat of widespread     antibiotic resistance rendering many antibiotics useless against important diseases, there is     an increased necessity not only to minimise antibiotic use and develop novel     non-antibiotic-based treatments, but also to raise the profile of disease prevention. One     approach that has gained interest over recent years is the use of probiotic bacteria for oral     applications. The rationale for their use in oral health care stems from the increase in     evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an     important role in the maintenance of health by stimulating the natural immunity as well as by     contributing to the balance of the microflora, by interacting with the other members of the     flora. The application of health promoting bacteria for therapeutic purposes, is one of the     strongest emerging fields. Time has come to shift the paradigm of the treatment from specific     bacteria elimination to alteration of the bacterial ecology by using probiotics.      So the purpose of this study is to discover a more promising approach for the treatment of     chronic periodontitis .   "
68383|NCT02390674|"     Routine primary percutaneous coronary intervention (PPCI) for a heart attack involves opening     a blocked artery with a balloon then inserting a metal scaffold (stent) to hold the artery     open. During this procedure inflammation can occur causing further damage to the heart. The     objective of this trial is to determine whether administration of the drug ciclosporin prior     to PPCI reduces the amount of damage to the heart relative to treatment with placebo. The     damage to the heart is assessed after 12 weeks by an magnetic resonance imaging (MRI) scan.     Patients are followed-up after 12 months participation in the study.      This is a single centre study looking to recruit 68 patients.   "
68384|NCT02390661|"     The proposed study is randomised controlled trial where informed and consenting patients who     have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has     the device removed in the traditional manner without having a drain placed, and an     experimental group that will have a penrose drain placed under sterile conditions at the time     of removal of their device. The drain will be placed in the same site used for the APBI     device and no additional surgery will be performed. The drain will remain for 2-3 days and it     will be removed by the patient at home. They will return for their routine follow-up     appointments and be monitored for development of a seroma with the use of standard ultrasound     and physical exam. Hypothesis: Based on the null hypothesis there will be no difference in     the rate of seroma formation after the APBI device removal if a drain is placed.   "
68385|NCT02390648|"     Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who     has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy     is recruited. The patient who meets the eligibility criteria and provides informed consent is     randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by mouth     during the first 5 days of chemotherapy cycle. The study drug will be switched on the     subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice     versa). The primary outcome is the nausea score and vomiting during the first 5 days of each     chemotherapy cycle when receiving the study drug.   "
68386|NCT02390635|"     The goal of this clinical research study is to learn if positron emission tomography/     computed tomography (PET/CT) and whole body magnetic resonance imaging (MRI) can be used to     detect extramedullary myeloid leukemia (EML). EML is a type of cancer found outside of the     bone marrow and can be hard to detect with routine bone marrow monitoring, such as bone     marrow aspirations.   "
68409|NCT02390336|"     The concept of mobilization with movement, also referred to as a Mulligan mobilization, has     not been studied in patients with hip osteoarthritis, subsisting questions about the possible     effects in this population. The aim of this randomized controlled study is to compare the     immediate effects of Mulligan mobilization with movement technique of pain, range of motion     and physical function in patients with osteoarthritis of the hip.   "
68387|NCT02390622|"     Methicillin-resistant Staphylococcus aureus (MRSA) is one of the major sources of nosocomial     infection. Along with the widely application of antibiotics around perioperative period, MRSA     infection is increasing by years.Fecal microbial transplantation (FMT),infusion of fecal     preparation from a healthy donor into the GI tract of a patient is being proposed as a novel     therapeutic approach to modulate diseases associated with pathological imbalances within the     resident microbiota, termed dysbiosis.It has been used to treat intestinal disease such as     inflammatory bowel diseases and Clostridium difficile infection, but no reports are available     on its role in treating MRSA enteritis yet. vancomycin is the first choice to treat MRSA but     can also lead to an increase in antibiotic resistant organisms such as vancomycin-resistant     enterococci, methicillin-resistant Staphylococcus aureus and transfer of antibiotic     resistance genes among the microbial community. So FMT seems a more harmless and reasonable     measure to treat similar diseases.   "
68388|NCT02390609|"     The purpose of this study is to assess the relative bioavailability (the extent to which a     drug or other substance becomes available to the body) of ibrutinib in healthy adults     following single oral dose administration of suspension and sprinkle formulations under fed     and fasted conditions compared with capsules under fasted conditions.   "
68389|NCT02390596|"     The study is designed to assess the efficacy and safety of anakinra, an interleukin 1     receptor antagonist, in patients with Kawasaki disease who failed to respond to standard     treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.   "
68390|NCT02390583|"     This is an open label randomized controlled trial, comparing two modes of treatment for     internet addiction (gaming or gambling online) with sleep disorders associated.   "
68438|NCT02389959|"     This is a randomized, controlled, double-blind, placebo-controlled trial of intranasal     Avastin (bevacizumab) injection versus saline control for control of HHT-related epistaxis     when used in conjunction with bipolar electrocautery.   "
68439|NCT02389946|"     The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus     Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or     restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent     system.   "
68393|NCT02390544|"     The purpose of this study is to examine the pharmacokinetics (PK) of melphalan in children     undergoing hematopoietic stem cell transplantation (HSCT). Melphalan is an important     component of HSCT preparative regimens, but can be associated with significant toxicity. PK     data is a powerful clinical tool that, when used to develop individualized treatment plans     for a specific patient, may ultimately increase the likelihood of selecting the right dose     for the right patient and/or of reducing the number of adverse drug events. The     investigators' goal is to establish baseline pediatric melphalan PK data. These data may be     used for patient specific dosing of melphalan in the future to minimize toxicity and improve     transplant outcomes.   "
68394|NCT02390531|"     The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than     currently used for severe retinopathy of prematurity (ROP), is effective in this study, and     can be tested in future larger studies.   "
68395|NCT02390518|"     This is a Phase I dose escalation trial. The purpose of this study is to determine the     maximum tolerated dose of radiation received during stereotactic radiosurgery in patients     with brain metastases who have never received radiation to the brain before.   "
68396|NCT02390505|"     Vitamin C with its antioxidant role has many indications. The objective of this study is to     demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of     complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the     upper limb.   "
68397|NCT02390492|"     This 2-period, open-label, nonrandomized study will be conducted to determine the absolute     bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its     metabolite(s). Healthy male participants will receive a single 200-mg oral dose of     ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of [14C]-ipatasertib.     After a 4-day observation period and 10-day washout, participants will receive a single     200-mg/100-mcCi oral dose of [14C]-ipatasertib with subsequent data collection for an     additional 7 to 14 days until discharge criteria are met.   "
68398|NCT02390479|"     The primary objective of this case-control intervention study to explore the effectiveness of     non surgical periodontal therapy on the gingival crevicular fluid (GCF) levels of sclerostin     in patients with chronic periodontitis (CP) so as to get a more detailed insight into its     diagnostic and prognostic potential as a biomarker of periodontal disease.   "
68399|NCT02390466|"     The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled     HIV patients receiving standard of care antiretroviral treatment.   "
68400|NCT02390453|"     This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise     training versus control condition on executive cognitive function in older adults with mild     cognitive impairment (MCI).   "
68401|NCT02390440|"     This study is looking at a novel therapy of numbing medication injected directly around the     fracture site. The purpose of this study is to determine if the study medication, EXPAREL®,     is a viable alternative to current therapies for rib fractures.   "
68402|NCT02390427|"     This research study is a way of gaining new knowledge about the combination of Taselisib with     other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational     drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps     cancer cells grow. This drug has been used in laboratory experiments and information from     these studies suggests that this drug may help to prevent or slow the growth of cancer cells.     The main purpose of this study is to find the appropriate dose of Taselisib to be used with     other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib     study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2     dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D).   "
68410|NCT02390323|"     This study is intended to evaluate a monitor that will facilitate ascertainment of an     effective sympathetic blockade following Lumbar Sympathetic blocks. Utilization of a monitor     with a rapid response and easy clinical applicability which can demonstrate effective     sympathetic block would increase efficiency within the procedure suite and also serve to     function as an objective endpoint for the evaluation of sympathetic blockade in future     research.In current clinical practice, the most commonly used monitoring methods are clinical     observations of sympathetic blockade, skin temperature monitoring, pulse pressure monitoring     and any combination of these monitoring methods. The skin temperature and pulse pressure may     increase after sympathetic block. However, changes in the skin temperature and pulse pressure     often demonstrate an unpredictable or delayed response. Confounding variables, such as     ambient temperature, coexisting vascular disease, use of other vasoactive medications may     contribute to inconsistencies in the temperature or pulse pressure responses.      Normal sympathetic activity stimulates muscarinic receptors in the periphery that     subsequently stimulate the sweat glands to secrete and fill with sweat containing sodium and     other electrolytes. The electrolytes present in the sweat increase the electrical conductance     while decreasing the electrical resistance at the skin level.      The real-time changes in skin conductance indices can be monitored at the skin level, by use     of non-invasive electrodes attached to the skin (similar to EKG electrodes). A computer     program analyzes the data and produces a real-time graphic and numeric data demonstrating the     skin conductance response. The initiation of successful sympathetic blockade can cause rapid     cessation of the skin sympathetic activity that leads to a decrease in skin conductance     within seconds.   "
68411|NCT02390310|"     This is a research study in Kenya that will examine the outcomes of participants aged 10-15     and 16 and older; and provider acceptability of the Shang Ring technique for male     circumcision that would simplify use. The study will be in two phases:      Phase 1 will explore the no-flip technique that has been used in China but will be used for     the first time in Africa.      Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.   "
68412|NCT02390297|"     Long term safety follow-up of Cal-1 recipients   "
68413|NCT02390284|"     Glaucoma is a progressive disease resulting in blindness. Determining the onset of the     disease, predicting its severity and the benefit of pressure lowering eye drops is key to     clinical management aimed at maintaining useful vision with advancing age. This study will     longitudinally monitor a population of glaucoma suspects (with positive factors for the     disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other     standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells     (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before     dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with     abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG     will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography     (OCT) and other ancillary tests every 6 months over 4 years.   "
68493|NCT02389244|"     INDICATION:      Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone,     intermediate or high-grade chondrosarcomas and chordomas   "
68414|NCT02390271|"     Introduction: Health care that addresses the emotional regulation capacity of patients with     schizophrenia confronted with daily stress may contribute to a less anxious life. A     psycho-physiological training (cardiac coherence training; CCT) focusing on emotion     regulation is known to decrease anxiety for non-clinical individuals.      Methods: the investigators performed a pilot cross sectional survey to explore the benefits     of CCT for clinically stable patients with schizophrenia. Ten patients were enrolled in the     program consisting in height to twelve weekly one hour session program during a 2-month     follow-up. Standardised questionnaires were used before and after the intervention assessing     anxiety, well-being outcomes, and how patients deal with stress and stressors.   "
68415|NCT02390258|"     This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects.     Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of     XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also     without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be     assessed following dosing for 10 days in Part 3.   "
68416|NCT02390245|"     Our goal is to conduct a 5-year prospective, randomized controlled trial to test an     innovative, community-based intervention using posterior and anterior fundus photography of     the optic nerve and macular images to improve access and utilization of eye care to detect,     treat, and manage high-risk patients with previously undiagnosed glaucoma and other eye     diseases. Research shows that subject failure to attend follow-up eye care appointments     diminishes any previous benefits of community screenings for glaucoma. Greater adherence to     follow-up visits can reduce glaucomatous blindness.   "
68417|NCT02390232|"     In a population of patients with Non Alcoholic Fatty Liver Disease (NAFLD), the investigators     will compare the composition of the gut microbiota from patients with simple steatosis with     that with steatohepatitis.      The purpose of this study is to determine if the pathogenic Escherichia Coli to the B2 group     and producing the genotoxin colibactin is a factor for developing NASH.   "
68418|NCT02390219|"     The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination     therapy in subjects 12 years and older with CF and advanced lung disease and who are     homozygous for the F508del CFTR mutation   "
68419|NCT02390206|"     The purpose of this study is to document the effectiveness of treating chronic post-stroke     spastic patients with Botulinum Toxin type A.   "
68420|NCT02390193|"     Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public     health problems, becoming a global epidemic. It is also known that the amount of displacement     of overnight rostral fluid, from the lower limbs, is related to increased neck circumference     and severity of obstructive sleep apnea (OSA) in patients with end-stage renal disease.     Method / Design: A clinical trial study aiming to assess the degree of collapsibility of the     upper airway in patients with CKD undergoing hemodialysis has been proposed. The test of the     negative expiratory pressure and nocturnal polysomnography will be performed before and after     the hemodialysis session. Discussion: The incidence of CKD has increased, due to the     increased number of cases of diabetes mellitus and hypertension. Our hypothesis is that the     weight gain due to volume overload, observed in the interdialytic period, will exert a     negative influence on the degree of collapsibility of the upper airways predispose to OSA in     CKD patients.   "
68421|NCT02390180|"     Recent research indicates that fatty acids in food may have a taste. There is no lexicon to     describe the sensation of the fatty acids, but participants frequently describe the sensation     as bitter or sour. The proposed study will ask participants who have been screened for their     ability to detect fatty acids to sort a variety of taste stimuli, including sweet, sour,     salty, bitter, umami, and fatty acid tastes. Observing how the participants sort the stimuli     will allow us to determine if the fatty acid taste is unique from other taste sensations.   "
68422|NCT02390167|"     The purpose of this study was to determine if untrained subjects with diabetes and without     diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain     valid glucose results.   "
68424|NCT02390141|"     The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending     doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety,     tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are     planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of     ZP4207 or placebo in a 3:1 treatment allocation at trial site.   "
68425|NCT02390128|"     This is an observational study in pregnant mothers and their newborn babies. The rationale of     the study is to examine early markers of the effects of iodine insufficiency during pregnancy     on thyroid stimulating hormone (TSH) and thyroglobulin in mother and baby.   "
68426|NCT02390115|"     The stroke is the second cause of death and the first of disabilities in the world. Although     a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity     present alterations of upper extremity, limiting the performance of daily activities even     after 2 to 4 years of strokes. More recently used in neurological rehabilitation, the ability     to promote sensory-motor facilitation is given to the Elastic Tape (ET). However, its safety     and efficacy in the treatment of post-stroke individuals still require further investigation.     Thus, the objective of this project is to evaluate the immediate effects of ET, applied to     the paretic shoulder on proprioception during movements of abduction and flexion of the     shoulder and muscle activation and kinematic variables for the reaching in chronic     hemiparetic. Fifteen subjects with chronic hemiparesis will participate these crossover     sham-controlled trial. Participants will be randomized into two condition: elastic tape (ET)     followed by sham tape (ST- strapping) or ST followed by ET. One month of washout period was     considered. The motor impairment and the dominance before stroke will be evaluated by     Fugl-Meyer scale and the Inventory Side dominance of Edinburgh, respectively. ET will apply     deltoid (anterior, middle and posterior). Assessment before and after the application of ET     will be performed. For proprioception assessment (joint position sense) will be evaluated     using a dynamometer. Absolute error for shoulder abduction and flexion at the 30° and 60° was     calculated. For the assessment of motor performance in a functional task (reach a glass of     water), spatio-temporal parameters (total duration of the motion, peak velocity, time to peak     velocity) and three-dimensional joint kinematics of the trunk, scapula, shoulder, and elbow     (total range of motion, joint angle maximum and minimum) will be used. Concomitantly,     bilateral activation of the deltoid (anterior, middle and posterior), trapezius (upper and     lower), serratus anterior and pectoral major will be assessed by electromyography during     reach. The following electromyographic variables will be analyzed: activation amplitude,     muscle onset and maximum and minimum activation. For statistical analysis, the normality and     homogeneity tests will be applied. If the variables have a distribution considered normal and     homogeneous, Two-way ANOVA with repeated measures gift will be applied. Otherwise it will be     applied to non-parametric statistics Friedman. Will be considered a 0.05 significance level     for all statistical tests.   "
68427|NCT02390102|"     The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in     reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis     undergoing transcatheter aortic valve replacement.   "
68428|NCT02390089|"     Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD)     versus healthy adults. This is of particular public health concern given that death secondary     to aspiration pneumonia and lung infection is a leading cause of death in persons with PD.     Swallowing and cough function are affected in PD, putting people with PD at significant risk     for uncompensated aspiration (aspiration without adequate cough response). One challenge in     the management of airway protective deficits related to PD is the chronic and progressive     nature of the disease, where swallowing dysfunction appears subtly in the form of     microaspiration, reducing the perceived urgency of the swallowing disorder by both clinicians     and patients. The long-term goal of this research is to advance the management of airway     protection deficits in patients with neurodegenerative disease in order to decrease morbidity     and mortality due to aspiration related lung infection. The objective here is to further     specify deficits leading to uncompensated airway compromise in PD in order to advance the     clinical management of these patients, leading to an immediate positive impact.   "
68429|NCT02390076|"     The goal of this project is to use low-level light therapy (LLLT) to enhance neural     metabolism in the prefrontal cortex of humans, and measure the effects of LLLT on attentional     bias change following a single session of attention bias modification (ABM). LLLT is     non-invasive, therapeutically beneficial, and promotes a wide range of biological effects     including enhancement of energy production, gene expression and prevention of cell death.     Previous research has indicated that human participants show a beneficial psychological     effect, including improved mood and greater sustained attention, following a single treatment     of LLLT to the forehead. ABM is a computer-based cognitive task designed to decrease the     mood-congruent negative attentional bias frequently observed in depressed and dysphoric     individuals. Previous ABM studies have led to decrease in clinical symptoms relative to a     control condition. This study will explore whether the effects of LLLT on mood and attention     could improve the potency of ABM, leading to greater attention change and greater improvement     of mood relative to sham LLLT.   "
68430|NCT02390063|"     This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine     that could be a new way to treat cancer. A vaccine that could alert the immune system to the     presence of cancer cells in the body may enable the immune system to target and kill those     cells effectively. This vaccine is intended to work by making the immune system kill cells     that have a special protein (called 5T4) that is present on the surface of cancer cells. The     vaccine is made up of two recombinant viruses (ChAdOx1 and MVA) that have been designed     to produce the 5T4 protein and have been modified so that they are weakened and cannot     reproduce themselves within the body like normal viruses. Once injected into the body, these     viruses make the 5T4 protein and help the body's immune system to learn to target this     protein and destroy cancer cells.      This is a first-in-human study to evaluate the safety and immunogenicity of     ChAdOx1.5T4-MVA.5T4 vaccination regime. It is evaluated in neo-adjuvant setting in low and     intermediate risk localised prostate cancer patients who have either decided to have their     prostate removed or are stable on active surveillance.   "
68431|NCT02390050|"     The purpose of this study is to investigate the effect of bexagliflozin in lowering     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin     is an orally administered drug for the treatment of T2DM and is classified as a Sodium     Glucose co-Transporter 2 (SGLT2) Inhibitor. This study will enroll both treatment naive and     those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320     subjects eligible for randomization will receive bexagliflozin tablets, 5, 10, 20 mg or     placebo, once daily for 12 weeks in an outpatient setting.   "
68432|NCT02390037|"     The objective of the study is to assess the incidence of safety outcomes in patients treated     with Pipeline™ Flex embolization device with Shield Technology™.   "
68448|NCT02389829|"     Opioids are commonly used to treat migraine in North American Emergency Departments. We are     comparing efficacy and adverse events of hydromorphone, an opioid, to that of     prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine     will be combined with diphenhydramine to prevent adverse events.   "
68433|NCT02390024|"     Mechanical ventilation (MV) is a vital support tool for critically ill patients. However, it     may present several adverse effects, such as the development of cognitive and     psychopathological alterations. Patient-ventilator asynchronies occur frequently since the     beginning of the MV. These asynchronies are associated with poor clinical outcome and could     be responsible for the neuronal changes causing these alterations. The objective of this     project is to analyze the influence of patient-ventilation asynchronies in the development of     long-term cognitive/psychopathological impairments and to explore the molecular mechanisms     that could explain of these alterations. An exploratory, observational, multicenter,     non-interventionist study will be performed in 150 ICU patients. The continuous recording of     asynchronies and other clinical variables during ICU stay and the results of     neuropsychological assessments will enable to identify clinical clusters associated with     cognitive/psychopathological impairments.   "
68434|NCT02390011|"     This is a single center pilot study testing the use of novel coil arrays with MR liver     imaging. In part A of the study, up to 30 healthy volunteers will be scanned, with iterative     adjustment of coil array geometry and design to optimize imaging characterstics. In Part B of     the study, 40 patients with advanced solid tumors and at least one liver metastasis measuring     > 1.5 cm in diameter on standard anatomic scans will undergo MR liver imaging with the newly     designed coil array, with the use of gadolinium contrast. Patients with liver tumors will     have the option of undergoing a second MR liver scan during the course of subsequent systemic     therapy.   "
68435|NCT02389998|"     This study is aimed at investigating the efficacy of placebo for symptom relief in children     with abdominal pain related functional gastrointestinal disorders.   "
68436|NCT02389985|"     The purpose of this study is to estimate the maximum tolerated doses (MTD) of CRLX101 when     administered in combination with weekly paclitaxel in women with recurrent or persistent,     epithelial ovarian, fallopian tube or primary peritoneal cancer.      Determine through pharmacokinetic evaluation(sometimes described as what the body does to a     drug, refers to the movement of drug into, through and out of the body-the time and course of     its absorption, bioavailability, distribution, metabolism, and excretion) whether or not the     disposition of paclitaxel is affected by the concurrent administration of CRLX101.   "
68440|NCT02389933|"     Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide     access to life-saving treatment with LCZ696 for patients that were not previously exposed to     LCZ696 but have no other option to receive LCZ696 in their country prior to market     authorization OR commercial availability, based on local regulatory and legal requirements.   "
68441|NCT02389920|"     Describe the purpose of the study: This study aims to evaluate the improvement of     Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring     the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia     chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.   "
68442|NCT02389907|"     Assessing the association between patients' perceptions of success with post-operative pain     management and overall experience with care.   "
68443|NCT02389894|"     To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain     injury in patients undergoing surgical aortic valve replacement (AVR).   "
68444|NCT02389881|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     multiple doses of TAK-058 in healthy non-elderly and elderly participants.   "
68445|NCT02389868|"     The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug     Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize     the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims     to characterize the biological and inter-individual variation of platelet's proteome as     measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of     changes induced by Lovastatin on the platelet's proteome may allow the discovery of     modifications relative to the effects of statins on hemostasis and the lipid profile.   "
68446|NCT02389855|"     The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It     employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by     tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in     nearly 300 procedures conducted at approximately 20 leading institutions across the United     States. This post-market, multi-center retrospective study is designed to collect long-term     follow-up data on patients who were treated previously with NBS.   "
68447|NCT02389842|"     Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K     inhibitors taselisib, or pictilisib. There are two treatment arms during the dose escalation     phase where patients will receive either taselisib OR pictilisib in combination with     palbociclib. Palbociclib, taselisib and pictilisib can all be given orally once daily with     food, in a 21-days-on and 7-days-off schedule. Once the MTD is reached, the combination with     the optimum safety and PK/PD profile will be taken forward to the dose expansion phase (Part     B).      Part B1: At the MTD dose expansion, fulvestrant will be administered in addition to     palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off     schedule in the ER+ve HER2-ve PIK3CA mutant breast cancer cohort. Fulvestrant will be given     intramuscularly on Day 1, Day 15 in cycle one followed by Day 1 for all subsequent cycles.      Part B2: At the MTD dose expansion, patients with PIK3CA mutant advanced solid tumours will     be treated with palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on     and 7-days-off schedule.   "
68449|NCT02389816|"     The purpose of this study is to evaluate the efficacy of two fixed doses of Lu AA21004 (10 or     20 mg/day) after 8 weeks of treatment in patients with MDD in Japan   "
68450|NCT02389803|"     Study design:      Double blind, randomized, placebo controlled study. Participants will be randomly assigned     either to the intervention group or the placebo control group. Randomization for the two     study groups will be made in a ratio of 1:1.      The primary objective of the study is to assess the effect of 6-12 months treatment with     nutritional supplementation standardized formula, in short and lean boys adolescents on     weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study     are to assess the effect of 6-12 months treatment with nutritional supplementation     standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to     puberty, quality of life and self-esteem The study will continue for 6 months of intervention     versus active placebo, with additional optional 6 months (an extension period), in which     participants at both groups, the intervention and the placebo, will be offered to continue     their participation in the study with the study supplement. All analyses of the effect's on     primary and secondary outcome measurements will take into account the consumption rate of the     study formula/placebo   "
68451|NCT02389790|"     The primary objectives of the study are:      -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to     severe active Crohn's Disease（CD）   "
68452|NCT02389777|"     This phase II clinical study will include fifteen healthy light skinned adult volunteers. At     screening subjects will be given a sunburn test. This procedure involves exposing eight 1     square cm areas of skin over increasing doses of simulated solar radiation (SSR). SSR is     delivered by a 1,000-Watt xenon arc lamp, which emits ultraviolet wavelengths from 290-400     nm, closely resembling natural sunlight. The Minimal Erythema Dose (MED) will be determined     approximately 24 hours after initial exposure by using a chromometer. The MED is calculated     by linear regression. Each test site is a one inch square area on the buttock or lower back.     Sites 1, 2, 3, 4, 5 will be irradiated with 2 MED of SSR. Site 1 will not receive any ACCS     treatment. Sites 2 and 3 will be treated with ACCS immediately after irradiation. 8-12 hours     later or at bedtime, Sites 2,3,4,5 with ACCS at home. ACCS will also be applied 24 hours     after SSR. Between 24-36 hours after SSR, subject returns to the Skin Study Center for     Minolta chromometer assessment of erythema at all test sites, as well as for high resolution     digital photography (Canfield). These assessments will be repeated at 48 hours and 72 hours     post SSR. Data will be graphed to quantify rate of erythema resolution. Punch biopsies will     be obtained at Site 1 (control) and Site 2 (SSR + immediate ACCS Rx). If a difference in     erythema is observed between Site 1 and Site 4, a biopsy will also be obtained from Site 4     (SSR + delayed ACCS Rx). Biopsy samples will be tested using Reverse Transcriptase     -Polymerase Chain Reaction (RT-PCR) and/or immunohistochemistry for markers of UV     inflammation such as Interleukin (IL)-6, Tumor Necrosis Factor (TNF) -alpha, etc. Subjects     will continue to apply the ACCS twice daily on Sites 3 and 5 until study visit 5. An     additional normal control skin biopsy may be performed in a subset of volunteers (4-5) to     serve as reference control for the tissue analysis.   "
68453|NCT02389764|"     The goal of this clinical research study is to learn if Ofev® (nintedanib, also called     BIBF1120) can help to control IBC. The safety of this drug will also be studied.   "
68454|NCT02389751|"     The goal of this clinical research study is to find the highest tolerable dose of ganetespib     that can be given in combination with standard chemotherapy (paclitaxel and carboplatin) and     radiation therapy in patients with esophageal cancer.   "
68455|NCT02389738|"     The blood-brain barrier (BBB) is an intricate barrier composed of a variety of efflux pumps,     a luminal negative charge, a basal lamina and three distinct cell types: brain endothelial     cells, pericytes, and astrocyte foot processes. Specifically, the BBB integrity and degree of     permeability is regulated by the capillary endothelial cells in response to astrocytic     signals. The strength of intercellular junctions (ex. tight junctions, adherins) amongst     endothelial cells also plays a major role in permeability. Therefore, modulation of all these     paracellular properties may decrease BBB integrity and thus improve drug penetration to the     tumor bed. Previous studies utilizing the vasoactive peptide, Regadenoson, demonstrated     transient increase in BBB permeability, allowing a 70kD dextran molecule to enter the brain     of rodents. Thus, the investigators propose to evaluate brain interstitium concentrations of     temozolomide pre and post Regadenoson using brain microdialysis. If Regadenoson successfully     demonstrates effectiveness in disrupting the BBB, it could be of major importance in     improving the outcome of patients with a variety of brain tumors and other neurologic     illnesses.   "
68456|NCT02389725|"     What is the effect of two common tourniquet techniques on the first attempt success rate of     peripheral intravenous cannulation?   "
68457|NCT02389712|"     The FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or fluoxetine     in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the trial is to     have a better understanding of whether individuals with a particular gene type and other     inherited biological markers will have a good response to fluoxetine or lamotrigine, or     alternatively, would be more likely to have side effects to this medication.   "
68458|NCT02389699|"     Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during     surgery followed by external-beam radiation to the entire breast may kill more tumor     cells.The clinical trial is conducting to compare the effectiveness of radiation therapy     during surgery and whole-breast radiation therapy in treating women who have undergone     breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast     cancer.   "
68459|NCT02389686|"     The role of NSM is still controversial, mainly because of concern about the oncologic safety     of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most     widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to     assess the value of the INTRABEAM system for breast cancer.   "
68460|NCT02389673|"     Whether the patients with low grade ductal carcinoma in situ breast cancer should accept     radiationtherapy is uncertain.Radiation therapy uses high-energy x-rays to damage tumor     cells. Giving radiation during surgery followed by external-beam radiation to the entire     breast may kill more tumor cells.The clinical trial is conducting to find out the     effectiveness of radiation therapy during surgery in treating women who have undergone     breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.   "
68471|NCT02389530|"     Fluorescein is a dye agent that can be injected through an intravenous line. It has been     shown to help tell the difference between brain tumor tissue and normal brain tissue when it     is used together with a specialized filter on a microscope in the operating room. The     investigators plan to study the use of fluorescein in the removal of brain tumors at a low     dose.   "
68530|NCT02388763|"     The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone     hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high     luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced     humidity environment.   "
68461|NCT02389660|"     Effective, accessible, and affordable depression treatment is of high importance considering     the large individual and economic burden of depression. There is ample support for the     effectiveness of Internet-based Cognitive Behavioral Therapy (CBT) for depression which is     considered a promising alternative to routine depression treatment strategies. Most evidence     comes from randomized controlled trials, however, and not from research in routine practice.      The European Comparative Effectiveness Research on Internet-based Depression Treatment     (E-COMPARED) in Poland aims to compare the clinical and cost-effectiveness of blended CBT for     adults with major depressive disorder (MDD) with treatment as usual (TAU). The trial will be     conducted in routine mental health care in Poland, and is a part of the bigger project funded     by European Commission (Grant Agreement No: 603098). In this randomized controlled trial, a     total of 150 patients with MDD will be assigned to one of two conditions: 1) blended CBT, 2)     TAU. Respondents in both conditions will be followed until 12 months after baseline (measures     will be taken at baseline, 3 months, 6 months and 12 months).   "
68462|NCT02389647|"     The purpose of this study is to use an iatrogenic model of stroke, meaning those strokes     inadvertently caused by endovascular coiling of elective aneurysms, to study the biology of     stroke in humans.   "
68463|NCT02389634|"     The purpose of the study is to identify novel genetic and protein markers for the process of     cerebral vasospasm following aneurysmal subarachnoid hemorrhage.   "
68464|NCT02389621|"     The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo     for the treatment of thrombocytopenia in patients with chronic liver disease who are     undergoing elective invasive procedures.   "
68465|NCT02389608|"     Background: Transcranial direct current stimulation (tDCS) is currently considered a     beneficial method for patients with neurological problems due to the modulation of cortex     activity as well as the enhancement and prolongation of functional gains achieved during     physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects     of a session of tDCS over the primary motor cortex combined with functional electrical     simulation (FES) on electrical activity of the tibialis anterior muscle, balance and     distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A     further aim is to determine whether the effects of the combination of both stimulation     methods are better than those achieved when each method is employed alone. Methods/design: A     randomized, double-blind, crossover, cross-sectional study will be conducted involving 30     stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve     an identification and screening chart, the classification of motor impairment using the     Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified     Ashworth scale), electromyography of the tibialis anterior muscle, static balance and     cognitive dual-task balance (stabilometry) and plantar pressure. After the initial     evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES +     active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior     contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4)     placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be     administered over the primary motor cortex and FES will be administered over the tibialis     anterior muscle. The order of the different protocols will be randomized and both the     evaluator and patients will be blinded to which protocol is being administered.   "
78684|NCT02255942|"     Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric     Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves     as a Reference.   "
68466|NCT02389595|"     The purpose of this research study is to develop a vaccine against Human immunodeficiency     virus (HIV), a disease that causes AIDS in people,. The investigator will be looking at     viruses similar to HIV in animals. Since these viruses are very similar to HIV, the blood     from humans who have been exposed to HIV will be tested to see if the immune system will     recognize the HIV and prevent infection.      HIV targets the immune system by attacking certain T cells called CD4+ T cells. There are     parts on the AIDS viruses that help the virus infect these cells and other parts that help     the immune system prevent viral infection by activating protective T-cells that fight HIV.     Different T-cell populations are very important in most vaccines as they act as effectors     that work as part of the immune system to recognize and fight off HIV infection. When     effector T cells are activated by appropriate protective part(s) of the virus they either     block HIV from reproducing or kill HIV infected cells. By finding these common protective     parts of each of these human and animal AIDS viruses, the investigator hopes to make a     vaccine that helps the immune system prevent HIV infection by avoiding parts that attack CD4+     T cells and may worsen HIV infection and selecting for parts that stimulate effector T cells     that fight HIV infection.   "
68467|NCT02389582|"     Anticoagulation with heparin is indicated in several situations, such as acute coronary     disease (in combination with antiplatelet therapy) for the prevention and treatment of venous     thromboembolism and situations with high risk of thromboembolism. Recently, the latest trials     on anticoagulation for stroke prevention on atrial fibrillation have shown an increased risk     for acute mycardial infarction on patients submitted to new oral anticoagulants, such as     dabigatran. The mechanism is still unclear, however, in this context, some previous studies     about interaction between anticoagulants ( mainly heparin) and platelet aggregation have     shown conflicting results: while some suggest an inhibitory effect of heparin on platelet     function, others suggest that heparin could promote an increase in platelet activation. The     present study aims to assess the effects of the LMWH Enoxaparin and direct thrombin     inhibitor, Dabigatran, on platelet aggregation, studied and compared by different methods in     patients with chronic coronary artery disease (CAD).   "
68468|NCT02389569|"     This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial     (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A     total of 94 restorations of 66 participants were selected and assigned at random into four     groups: 1 (Biosilicate / Two-step etch and rinse system), 2 (Control / Two-step etch and     rinse system), 3 (Biosilicate / Two-step self-etching system) and 4 (Control / Two-step     self-etching system). Two operators carried out the adhesive protocols and restored the     cavities with a nano-hybrid resin composite (IPS Empress, Ivoclar) using the incremental     technique. Participants were recalled at one week, 6, 12 and 18 months for clinical     evaluation performed by two blinders and calibrated examiners according FDI criteria.   "
68469|NCT02389556|"     ANGPTL3 and ANGPTL8 are emerging molecules involving lipid metabolism. In previous in vivo     study using mice, ANGPTL8 regulated the activation of ANGPTL3 which was known to inhibit     lipoprotein lipase activity and stimulate lipolysis of adipose tissue. Besides, glypican 4     was identified as a novel adipokine modulating adipocyte differentiation. Thus, the     investigators postulated that different serum concentrations of ANGPTL3, ANGPTL8 and glypican     4 might affect progression of obesity in children. The investigators measure these molecules     in Korean children, and investigate the association between these molecules and development     of obesity.   "
68470|NCT02389543|"     This is an open-label, randomized clinical study with two stages to assess the maximum     tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone     (SLd) in patients with relapsed/refractory (RR) multiple myeloma (MM). The stages are dose     escalation (Phase 1) and expansion (Phase 2).   "
68472|NCT02389517|"     This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide,     ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that     remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system     kill abnormal blood cells or cancer cells and may also prevent the growth of new blood     vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer     cells by interfering with proteins necessary for cell growth. Drugs used in chemotherapy,     such as dexamethasone, work in different ways to stop the growth of cancer cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. It is     not yet known whether lenalidomide is more effective with or without ixazomib citrate and     dexamethasone in treating residual multiple myeloma.   "
68473|NCT02389504|"     An Investigation of Return to Play Exertion Protocol in Concussed Adolescents   "
68474|NCT02389491|"     The purpose of this study is to explore the effects of high density formula in early     postoperative infants with congenital heart disease and to assess its safety.   "
68475|NCT02389478|"     The purpose of this study is to explore the effects of Oropharyngeal administration of     colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the     protect immune function of colostrum to very low birth weight infants, to improve the     utilization of breast milk and reduce infection rates of very low birth weight infants.   "
68476|NCT02389465|"     Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that     there is a link between depression and inflammatory disease. This study investigates the     relationship between inflammation in the brain and depression. Comparing biological and     psychological differences in depressed and non-depressed people allows researchers to find     better ways to treat and prevent depression. All participants will have: neuropsych tests, an     EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant or placebo     for eight weeks. The investigators are trying to correlate brain function with depression     levels and biomarkers from the blood and spinal fluid.   "
68477|NCT02389452|"     Primary Objective:      To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of     Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).      Secondary Objective:      To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.   "
68548|NCT02388529|"     This study is a single-center, randomized, double-blind, placebo-controlled study in patients     with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and     efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.   "
68478|NCT02389439|"     This study is a prospective, single arm, open-labelled clinical trial. The total number     subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days.     Dosing will be according to the body weight.      All patients will have a blood smear examined daily during the first week by microscopy until     parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and     sexual stages). A negative blood slide will be defined as parasite count negative per 1000     WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h     after the initial blood smear.      Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21,     28, 35 and 42).   "
68479|NCT02389426|"     The aim of this study is to investigate the potential of Transcranial doppler (TCD) and     Near-Infrared Spectroscopy (NIRS), more simple and non-invasive bedside methods than magnetic     resonance imaging (MRI), to evaluate changes in the cerebral circulation between patients     with MS and control subjects.   "
68480|NCT02389413|"     The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of     PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild     dementia due to AD.   "
68481|NCT02389400|"     Study Type: Interventional      Study Design:      Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking:     Open Label Primary Purpose: Treatment purpose: This single arm clinical trial is studying     efficacy and tolerance of combination chemotherapy with methotrexate and cytosine arabinoside     in newly diagnosed adult with Langerhans cell histiocytosis.   "
68482|NCT02389387|"     The purpose of this study is to facilitate coordination of transplant centers in North     Carolina, South Carolina, and Georgia to share kidney transplant referral data in patients     with End-Stage Renal Disease (ESRD) who are candidates for kidney transplantation.   "
68483|NCT02389374|"     This is a study assessing safety and efficacy of current national guidelines for the     treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among     the enrolled patients.   "
68484|NCT02389361|"     Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a     classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with     Zaldiar (combination of paracetamol and tramadol).   "
68485|NCT02389348|"     This is a single-centre, open-label, dose finding study using induced blood stage malaria     (IBSM) infection to characterize the pharmacodynamic interaction between OZ439 and DSM265,     administered around 120 minutes apart for treatment of early Plasmodium falciparum blood     stage infection. The study will be conducted in up to three cohorts (n=8 per cohort) using     different doses of OZ439 and DSM265. The doses of OZ439 and DSM265 that will be investigated     in the first cohort will be 200 mg of OZ439 and 100mg of DSM265, both administered as single     doses around 120 minutes apart. Subsequent doses in subsequent cohort(s) will be determined     following a review of observed OZ439 and DSM265 safety, and pharmacokinetic and     pharmacodynamic interaction outcomes, particularly the antimalarial activity of the drugs     given in combination as defined by parasite clearance kinetics. The doses used in Cohort 2     and 3 may be adjusted but will not exceed the maximum acceptable doses predefined for this     study (which are 400 mg for DSM265 and 500mg for OZ439) as determined in previous safety and     pilot efficacy studies. The dose will be determined by the funding sponsor and the principal     investigator (PI) following Safety Review team (SRT) and scientific evaluation. If no safe     alternative dose can be determined the option exists to curtail the study to less than three     cohorts.      Each participant in the cohort will be inoculated on Day 0 with ~1,800 viable parasites of     Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. On an     outpatient basis, participants will be monitored daily via phone call and then daily (AM)     from day 4 (until PCR positive for presence of malaria parasites). Once PCR positive they     will be monitored twice-daily morning (AM) and evening (PM) until treatment, for adverse     events and the unexpected early onset of symptoms, signs or parasitological evidence of     malaria. On the day designated for commencement of treatment, as determined by qPCR results,     participants will be admitted to the study unit and monitored. The threshold for commencement     of treatment will be when PCR quantification of all participants is = 1,000 parasites/mL. If     the PCR quantification of any participant is = 5,000 parasites/mL and is accompanied by a     clinical symptom score >5, or if clinical or parasitological evidence of malaria occurs in     any participant before all participants have reached the treatment threshold (PCR     quantification of = 1,000), then treatment of that participant will begin within a 24 h     period.      Following treatment with OZ439 and DSM265, participants will be followed up as inpatients for     at least 48 hours to ensure tolerance of the treatment and clinical response, then if     clinically well on an outpatient basis for safety and clearance of malaria parasites via PCR.      Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) will occur on     study day 16 ±3 days post OZ439 and DSM265 treatment unless required earlier. Early standard     anti-malarial drug intervention can occur if either poor responses or fast responses are seen     following OZ439 and DSM265 treatment. This is to ensure participant safety and to avoid     participant inconvenience if useful data cannot be obtained. A poor response is defined as a     decrease in parasitaemia of less than 20% from baseline by 3 days post OZ439 and DSM265     treatment. A fast response occurs when, within the seven day period following the treatment,     two consecutive PCR assessments in 48 hours are negative. However, pre-emptive treatment with     Riamet® can commence whenever deemed necessary by the investigator. Participants will be     monitored, either in clinic, or by telephone for three days to ensure adherence to Riamet®     therapy.      Participants will be treated with a single dose (45 mg) of primaquine as described in section     4.3 in this protocol at the end of their Riamet® treatment if gametocytes are identified, to     ensure complete clearance of any gametocytes present.      Adverse events will be monitored via telephone monitoring, within the clinical research unit,     and on outpatient review after malaria challenge inoculation and antimalarial study drugs     administration. Blood samples for safety evaluation, malaria monitoring, and red blood cell     antibodies will be drawn at screening and/ or baseline and at nominated times after malaria     challenge.   "
68486|NCT02389335|"     The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis     is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles     in β cell destruction.   "
68487|NCT02389322|"     The investigators select 500 subjects who meet the standard and are considered as study     population I. Do specific gamma-interferon detection before the skin test， then inject     intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD)     at different arm of the same subject and get 192 participants whose three kinds of detection     result are all negative and are considered as study population II.Then,they are immune to the     Bacillus Calmette-Guerin (BCG) vaccine or the placebo of the BCG. Do specific     gamma-interferon detection before the skin test， then inject intradermally with two dosage     ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative     rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of     different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.   "
68488|NCT02389309|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of dasatinib, cyclophosphamide, and temsirolimus that can be given to patients     with advanced solid tumors. The safety of this drug combination will be studied. As secondary     aim the study will evaluate treatment response to this combination and biological markers.   "
68489|NCT02389296|"     The aim of this study is to determine whether the work environment influences the role     perception of nurses in psychiatric wards. This will be a comparative study. Questionnaires     will be distributed to nurses working in psychiatric wards in 10 medical centers in Israel.   "
68490|NCT02389283|"     Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and     peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones,     joint capsule, tendons and ligaments leading to the consequential functional joint     deterioration.      The main goal of RA treatment is to achieve disease remission. The treatment of RA consists     of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected     when low disease or remission is not achieved with the first ones. Therapeutic response     monitoring in RA should be closely managed. It is classically based on clinical exploration     and laboratory tests. During the last decade, the resolution improvement of musculoskeletal     ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the     evaluation and monitoring of patients with RA, mainly due to its better capacity to detect     synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive,     reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects     pathological synovial flow, which reflects synovial inflammation and has a demonstrated     sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients     with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by     ultrasound. There has been high variability in the literature regarding the number of joints     that should be evaluated for an appropriate monitoring of the RA patients. The validity for     monitoring the therapeutic response in long standing RA has been demonstrated in three     reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the     sensitivity to change of any of these reduced ultrasound evaluations has never been studied   "
68491|NCT02389270|"     The aim of this study is to analyse urinary neurotrophin levels in healthy children. Urine     samples will be collected at 3 different times of day (morning, noon, and evening) at urge     sensation from all age groups of children who gained bladder control, i.e. from 3-18 years of     age. Urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF)     normalised to urinary creatinine will be analysed. Age and daytime related variations will be     reported for both boys and girls. These results will contribute to understanding the role of     neurotrophins in the physiology of lower urinary tract and pathophysiology of idiopathic and     secondary hyperactive bladder in children.   "
68492|NCT02389257|"     Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields     measurement.   "
68494|NCT02389231|"     The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T     (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in     remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of     interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that,     over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in     patients with active wAHAI.   "
68495|NCT02389218|"     Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to     standardized medication for treatment of early onset persistent atrial fibrillation (AF)     without structural heart disease. The value of CBA in these patients has never been studied;     the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction     in left atrial (LA) size will be compared versus patients on drug therapy and versus failing     patients.   "
68496|NCT02389205|"     Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is     bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity     (Range of Motion) decreasing and other musculoskeletal and related disorder. Patients will     produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding,     and joint damage. There is high rate of ankle joint bleeding in hemophilia. The ankle     articular joint disease will affect lower limbs activities, and the functional activities     will impaired.      Review studies, in addition to physical therapy, Kinesio taping is a common intervention to     improve other subjects' static balance, proprioception, functional ankle stability, correct     poor posture.      The main intervention of this study is physical therapy and Kinesio taping, expect to improve     the stability and muscular strength of lower extremities, and balance, correcting gait and     lower extremity functional activities of subjects with hemophilia.   "
68497|NCT02389192|"     Background:      - Ebola is a virus that can spread quickly and causes serious disease. It is currently     causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a     new drug made of natural infection-fighting substances. Researchers want to see if it can     treat Ebola.      Objective:      - To assess the safety of ZMappTM and how the body processes it. To measure the immune system     response to ZMappTM.      Eligibility:      - Healthy people 18 50 years old.      Design:        -  Participants will be screened with a medical history, physical exam, and blood and urine          tests. They will have an electrocardiogram (ECG) to measure heart electrical activity.          Small pads will be stuck to the arms, legs, and chest.        -  Participants will be admitted to the hospital. They will have a physical exam,          medication review, and blood samples.        -  Two intravenous (IV) lines will be placed into separate arm veins. A needle will be used          to guide plastic tubing into the veins. One will be used to take blood samples. The          other will be used to give the study drug.        -  Participants will be given drugs to help prevent side effects.        -  Participants will be given the study drug by IV over 10 12 hours. Participants will be          monitored closely and vital signs taken frequently. They may have another ECG.        -  Blood samples will be taken before, during, and after the infusion.        -  Participants will stay in the hospital 1 or 2 nights after receiving the drug.        -  Participants will have several study visits over 90 days after getting the study drug.          They will be asked about side effects. They may have a physical exam, and blood may be          drawn.   "
68507|NCT02389062|"     This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten     ingestion in celiac disease patients who are following gluten free diet for at least a period     of one year. These noninvasive markers may be helpful to monitor the silent intestinal     damage, possibly resulting from the accidental consumption of gluten due to cross     contamination of gluten free diet.   "
68498|NCT02389179|"     Much research on vitamin D status has focused on seasonal variations in serum 25(OH)D levels     in populations living at high altitudes and those of light-skinned Caucasian extraction, with     little work done in multi ethnic populations living closer to the equator with regards to     Vitamin d supplementation, prevalence, predictors and associations of hypovitaminosis D - the     assumption, perhaps being vitamin D deficiency is unlikely in locations of plentiful     sunshine. There is a dearth of studies on Vitamin D status in a group of subjects at     especially high risk of falls/fractures i.e. post-menopausal women with osteoporosis living     in South-East Asia. It is possible that differences in geography and ethnicity/culture     amongst women with post menopausal osteoporosis (PMO) in Malaysia may necessitate     supplemental Vitamin D doses that differ from those prescribed to North American Caucasians.      There is no unified consensus on the dose of Vitamin D supplementation. Neither is there     agreement on definitions of sufficiency with some researchers targeting levels of serum     25(OH)D of >20ng/ml and others aiming for levels above 30ng/ml. The Institute of Medicine     (IOM) 2010 guidelines, aiming for a lower serum 25(OH)D target of 20ng/ml, advocates     maintenance doses of 600 IU/day in Postmenopausal women aged 51-70 and 800 IU/day for those     aged >70 years. On contrary, the Endocrine Society 2011 guidelines state that maintenance     doses up to 1500-2000 IU/day may be required to attain a higher optimal target of >30ng/ml.     On addition, the 2014 National Osteoporosis Foundation Guidelines recommended that the     Vitamin D level should be brought up to approximately 30ng/ml, and to maintain at this level     taking into account those with limited sun exposure, obese and dark skin individuals, the     daily requirement ranges from 800-2000 IU/day.      The investigators therefore designed a prospective randomized controlled trial comparing     efficacy and safety of a low (900 IU/day) and high (1800IU/day and 3300IU/day) maintenance     dose of Cholecalciferol (Vitamin D3) amongst community dwelling Indian and Malay with PMO     living in Kuala Lumpur, Malaysia.      Hypothesis of the study is despite abundant exposure to sunlight, which is the main Vitamin D     supplier, those who dress conservatively and individuals with darker skin may require a     higher dose of Vitamin D to maintain sufficiency (>30ng/ml).   "
68499|NCT02389166|"     Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV     session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial     Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when     NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow     oxygen delivery system used a heated humidifier and heated breathing circuit. In     observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory     failure. Oxygenation is better than under high-concentration mask and work of breathing is     reduced.      The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen     therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured     as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session),     during the first two NIV sessions      Study design : Prospective, randomized, controlled, multicentric, open clinical trial with     two groups:        -  control group with conventional clinical management, oxygen therapy and sequential used          of NIV        -  Optiflow group with high flow oxygen delivery system, conventional clinical management          and sequential used of NIV for a period of 36 hours at least.      Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for     hypoxemic respiratory failure.   "
68500|NCT02389153|"     The main focus of the pilot study is to evaluate the feasability and effectiveness of a     collaborative care intervention for patients suffering from a coronary heart disease (CHD)     with insufficient controlled health related risk factors in their lifestyle. The design of     the study is a wait list control design. 30 patients will receive treatment immediately after     submission, the other 30 after 6 months. An interdisciplinary team, including a care manager     for each patient, will offer an individualized treatment plan, based on shared decision     making for each patient to reduce risk factors and improve quality of life.   "
68502|NCT02389127|"     Cirrhosis and advanced liver disease have been associated with an increased risk for     hyperglycemia and type 2 diabetes mellitus (T2DM). The diagnostic yield of common tests used     to define diabetes and insulin resistance in the general population differs significantly     from the one observed in patients with liver disease. Glycosylated hemoglobin A1c (HbA1c), a     reliable test to assess chronic glycemia and recommended both for the diagnosis and     monitoring of T2DM, is neither accurate nor reliable in patients with cirrhosis. A validation     study has not been performed to define its true usefulness in the setting of cirrhosis. The     study aims to determine the level of HbA1c that better corresponds to the diagnosis of T2DM -     as determined by an oral glucose tolerance test (OGTT) - and to correlate the levels of HbA1c     with the average glucose over a 12-week period in patients with cirrhosis and known T2DM, in     cirrhotic patients with different degrees of liver impairment as compared to patients with     T2DM and no liver disease.   "
68503|NCT02389114|"     The primary hypothesis of this study is that the higher concentration of soy protein intake     will increase satiety and decrease the energy intake at the subsequent meal.      The secondary hypothesis is that the synergistic effect of soy protein and polydextrose will     further increase satiety and reduce energy intake at the subsequent meal.      The third hypothesis is that the ingestion of protein and polydextrose will differentially     impact on satiety-related metabolism, i.e. blood glucose, insulin, urea, plasma amino acids,     gut hormones and gastric emptying.   "
68504|NCT02389101|"     Lymphomas are classified as Hodgkin's or non-Hodgkin's lymphomas, of which especially the     latter represent a heterogeneous group with varying patterns of prognosis, biological     behaviour and response to treatment. 18F-FDG PET/CT is useful for staging and response     monitoring but has the disadvantage of associated radiation exposure which may not be     desirable for young patients. Advanced MRI techniques including diffusion weighted imaging     (DWI) are increasingly used for improved lesion detection and characterisation of lymphomas     and in the whole-body mode offer a promising radiation-free alternative to CT. Molecular     imaging in turn is important in theranostics medicine where detection of therapeutic target     is essential. The concept of theranostics has been successfully adapted to management of     neuroendocrine tumors (NET) where peptide receptor radiotherapy (PRRT) is offered to patients     progressing on treatment with long-acting somatostatin analogues.      Recently in the investigator's hospital a case of diffuse large B-cell lymphoma (DLBCL) was     initially misdiagnosed as NET because of high uptake of 68Ga-DOTANOC in pancreatic tumor at     PET/CT. A PubMed search revealed a similar case report in bronchial tumor which turned out to     be DLBCL (Jain et al. Clin Nucl Med 2014;39:358-359). Bearing these two cases in mind the     investigators now aim to systematically study somatostatin receptor status (ssr) by measuring     uptake of 68Ga-DOTANOC with PET/CT in patients with newly diagnosed non-Hodgkin's and     Hodgkin's lymphoma. The imaging findings will be compared to immunohistochemically determined     ssr-subtypes 2,3 and 5 obtained from pre-treatment fresh tumor samples and 18F-FDG PET/CT     which is part of standard diagnostic evaluation. Furthermore, whole-body MRI with DWI will be     performed before, during and after chemotherapy to define the most sensitive and specific     imaging method appropriate for routine diagnosis and follow-up. This study has potential     implications for future response monitoring and follow-up imaging techniques in patients with     malignant lymphoma and provides additional biologic characterization which may be useful for     novel therapeutic approaches such as PRRT.   "
68505|NCT02389088|"     The purpose of this study is to evaluate the effect of increased circulating androgens on     estradiol production by the granulosa cells in response to FSH stimulus.   "
68508|NCT02389049|"     This study is designed to study DNA sequencings for mutations in a research genetic test     panel of genes (which contains all 32 known and/or published genes associated with PCD). The     study aims to show that about 70% of PCD patients have biallelic mutations in one of these     genes. This project will enroll patients who have already had a clinical evaluation, and have     clinical features consistent with PCD.   "
68509|NCT02389036|"     Introduction- Hospital acquired infections (HAI) are a major cause of morbidity and mortality     and increase health care costs. Critically ill patients are particularly susceptible to these     infections and have an even higher mortality. One intervention that has gained much interest     in the medical literature for reducing infection rates and deaths from HAIs is selective     decontamination of the digestive tract (SDD). SDD involves the application of antibiotic     paste to the mouth, throat, stomach and a short course of intravenous antibiotics. The     evidence supporting the use of SDD for saving lives and preventing infections is actually     quite strong. However, health care professionals in many parts of the world have refrained     from using SDD due to fears of the effects of overuse of antibiotics on the frequency of     infections with resistant bacteria such as multi-resistant Gram negative organisms, MRSA and     Clostridium difficile.      SuDDICU-ANZ is a cross-over, cluster randomised trial comparing the effect of using selective     decontamination of the digestive tract (SDD) plus standard care, to standard care alone on     hospital mortality in patients receiving mechanical ventilation in the intensive care unit     (ICU).      Secondary outcomes include an ecological assessment and a long-term health economic analysis.   "
68510|NCT02389023|"     The purpose of this study is to evaluate the effectiveness of negative pressure incision     management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™     Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications     including surgical site infection (SSI) and non-infectious complications in patients     undergoing vascular surgery with groin incisions.   "
68523|NCT02388854|"     Endometriosis, defined as the presence of endometrial tissue outside the uterine cavity,     affects 6-10% of the general population of women in childbearing age.      The pathogenesis of the disease is unknown. The purpose of this study is to evaluate the     influence of certain polymorphisms of genes Transforming growth factor beta 1     (TGFB1),Vascular endothelial growth factor (VEGF), Epithelial growth factor receptor (EGFR)     and Platelet-Derived Growth Factor (PDGF) knowns to be involved in angiogenesis, tissue     remodeling and proliferation, phenomena necessary for the growth of ectopic foci of     endometrial tissue , and genes X-ray repair cross-complementing protein 1 (XRCC1), X-ray     repair complementing defective repair in Chinese hamster cells 3 (XRCC3) and xeroderma     pigmentosum group D (XPD) involved in DNA repair systems, needed in case of damage from     oxidative stress, another potential factor involved in the pathophysiology of endometriosis.     The study focus on the Sardinian population, known to have unique genetic characteristics due     to geographical isolation.   "
68511|NCT02389010|"     A novel method (PCT n. WO 2010/007502 A2, 2010) has been developed to obtain platelet gel     from umbilical cord blood (CBPG). The main advantages so far identified in CBPG as compared     to platelet gel derived from adult platelets relate to the lack of microbiological     contamination in the former and to a different profile of growth factors concentrations, such     as a higher content of VEGF and lower content of TGF in CBPG. Recent developments have led to     a procedure in which CBPG can be prepared, stored in a cryopreservation bag and applied to     the skin ulcer without breaking the sterility chain. In spite of promising results on     allogeneic CBPG, a randomized clinical trial of sufficient statistical power to detect     significant advantages (clinical and economical) will be performed in patients affected by     diabetic foot ulcers and randomly treated with CBPG versus standard local medications     (SLM).This study is a multicenter (8 centers) controlled randomized clinical trial. Outcomes:     (1) primary objective is to evaluate the number of closed skin ulcers within 4 weeks of     treatment with CBPG vs standard local medications; (2) secondary objectives are percent skin     ulcer closure area, number and type of adverse events and cost of treatment. Sample size     calculation: 95 + 5 (dropout) test and 95 + 5 (dropout) control patients ensure 80% power to     detect as statistically significant (p<0.05) >60% healing in test vs 40% healing in     control.Each clinical centre has been invited to enrol 15 treated and 15 control patients,     according to local availability in 12 months. CB units are routinely collected after mother's     informed consent before and after placenta delivery in accredited public cord blood banks     belonging to the Italian Cord Blood Network (ITCBN) coordinated by the Centro Nazionale     Sangue (CNS). After storage and transportation at monitored room temperature, the units will     be processed for the preparation of CBPG within 48 hours of collection. CBPG will be prepared     according to standard procedures with a defined final platelet concentration (0.8-1.2 x     109/L). The CBPC units will be finally cryopreserved in a -80°C freezer in view of the     clinical use of the CBPG, which will require thawing at 37°C in a waterbath and activation     with Calcium gluconate. For SLM, each clinical center will use their validated standard     procedures.   "
68512|NCT02388997|"     Population surveys have shown a positive correlation between increased levels of total serum     immunoglobulin E (IgE) and bronchial hyperreactivity. However, it is also clear that     exacerbations of asthma are frequently triggered by viral respiratory tract infections,     especially those caused by human rhinovirus (RV), also known as the common cold virus. This     protocol explores the relationship between rhinovirus and allergen/IgE provoked inflammation.     Experimental challenges with human (RV) result in more persistent upper respiratory tract     symptom scores in asthmatics than in controls. Asthmatics with high levels of IgE also show     greater sensitivity to methacholine and higher levels of expired nitric oxide (eNO) than     those with low levels of IgE. These data suggest that patients with asthma and high levels of     IgE are more likely to have pre-existing inflammation of the airways before virus challenge.     This study is being done to determine whether anti-IgE therapy (with omalizumab) will lead to     a significant decline in inflammatory biomarkers prior to virus inoculation, and thus reduce     the severity of clinical manifestations after an experimental human RV challenge.   "
68513|NCT02388984|"     The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping     Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).   "
68514|NCT02388971|"     The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in     participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving     standard-of-care (SOC) therapy.   "
68515|NCT02388958|"     Gestational diabetes mellitus (GDM) is associated with short-term and long-term complications     for infants and mothers. The management of GDM during pregnancy focuses on reducing risks to     the infant associated with hyperglycemia. The postpartum management of GDM focuses on     reducing maternal risk of developing type 2 diabetes (T2DM). A diagnosis of GDM identifies up     to 31% of parous women who will eventually develop T2DM and approximately 50% of women     diagnosed with GDM will develop T2DM in the first 5 years postpartum. The perceived risk of     developing short-term and/or long-term complications of GDM may influence women's likelihood     of engaging in diet modification, the mainstay of treatment of GDM, both during and after     pregnancy. If sustained after delivery, diet modifications introduced as treatment for GDM     could affect maternal weight changes during and after pregnancy, which could in turn affect     T2DM risk. It is unknown if and how women with GDM differ in their perceived risk of     developing T2DM, dietary choices, or weight gain (and retention) during versus after     pregnancy. Therefore, the project proposed in this application seeks to (1) characterize the     perceived risk of developing T2DM among women with GDM during and after pregnancy, (2)     characterize dietary choices of women with GDM during and after pregnancy, and (3)     characterize weight changes of women with GDM during and after pregnancy as compared to women     without GDM.   "
68516|NCT02388945|"     This prospective, randomized, controlled, multi-center clinical trial will evaluate the     validity and security of domestic APD machine compared with the patients followed CAPD.   "
68517|NCT02388932|"     This phase I trial studies the side effects and best dose of stereotactic body radiation     therapy in treating patients with head and neck cancer that has spread from where it started     to nearby tissue or lymph nodes and is at high risk for continuing to spread because the     patient cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a     specialized radiation therapy that delivers radiation directly to the tumor in smaller doses     over several days, which may kill more tumor cells and cause less damage to normal tissue.   "
68518|NCT02388919|"     Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with     advanced non-small lung cancer, with placebo control.   "
68519|NCT02388906|"     The purpose of this study is to determine whether nivolumab is better than ipilimumab to     prevent recurrence of melanoma.   "
68520|NCT02388893|"     As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective     endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team     including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry     is a prospective, national registry of patients with IE. From January 2013 data from     endocarditis board were prospectively recorded using standard definitions during the     hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of     IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.   "
68521|NCT02388880|"     The purpose of the study is to evaluate the physiological response to application of the     Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.     The study will evaluate the physiological response to intrathoracic pressure regulation (IPR)     therapy in hemodynamically stable patients with compromised cerebral circulation who are on     ventilatory support.   "
68522|NCT02388867|"     In the present study the investigators will evaluate MMPs. serum levels variations in     patients affected by critical limb ischemia, before and after lower limb surgical     revascularization through venous or prosthetic bypass.   "
68524|NCT02388841|"     ABSTRACT Pulmonary embolism shows a wide spectrum ranging from clinically asymptomatic     thrombus to massive thrombus, leading to cardiogenic shock. The purpose of this study was to     determine the association between thrombus localization and risk factors, accompanying     disorders, D-dimer and the red blood cell distribution width (RDW) in patients with pulmonary     embolism.   "
68525|NCT02388828|"     This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received     retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol     have received lentiviral modified T cells engineered to express an anti-mesothelin scFv     Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses     are a subfamily of retroviruses. This protocol is designed in adherence with the November     2006 Food and Drug Administration (FDA) Guidance for Industry, Monitoring for Delayed     Adverse Events and Supplemental Guidance on Testing for Replication Competent Retrovirus in     Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical     Trials Using Retroviral Vectors  and involves up to 15 years of monitoring of subjects who     have been exposed to retrovirus-mediated gene transfer. Subjects will undergo biannual visits     for a blood test evaluating persistence of cells with retroviral vector sequences, chemistry,     hematology and tumor markers (as applicable). On annual visits, subjects will further undergo     a physical exam and medical history (including concomitant medications and adverse events)     with careful attention to features possibly related to retrovirus-induced diseases   "
68526|NCT02388815|"     To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used     at home by children with diabetes.   "
68527|NCT02388802|"     Ten patients will undergo uterine transplantation.   "
68528|NCT02388789|"     The purpose of this study is to investigate whether mechanoreceptor sensitivity of the sole     of the feet increases with increased foot temperature and how a heightened sensation may     improve characteristics of balance control and gait. As an extension, the investigators also     want to determine whether lower limb movement is an efficient activity of increasing foot     temperature. There are several objectives of this study. The investigators want to determine     the effect of active recovery (via lower limb movements) on increasing plantar temperature,     determine the effect of increased plantar temperature on plantar sensation and determine the     effect of increased plantar sensation on balance control and gait characteristics.     Participants will be asked to complete various tasks under different conditions. Conditions     include decreased feet temperature via ice bath emersion, baseline feet temperature     (participant's normal temperature after a ten minute equilibration period), and increased     feet temperature via active movement of the lower limb. Tasks include walking across the     room, performing active movement of the lower limb and a 10 minute treadmill walk. Gait     movement will be collected with a three-dimensional motion capture system (Optotrak) and     force plates. Feet temperature and sensation information will be collected with a temperature     probe (infrared) and monofilaments.   "
68529|NCT02388776|"     This is an interventional pilot study of 40 burn inpatients. Specific aims of the proposed     pilot study are to use bedside blood analysis with rotational thromboelastometry (ROTEM) in     severe burn patients to provide preliminary information on the nature of coagulation     abnormalities and compare subject ROTEM coagulation profiles within 24 hours of burn injury     (day 1) and on days 2, 3, 5, 7, 14 and 21 after burn injury.   "
68531|NCT02388750|"     This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis     or rescue of single or multiple fraction radiation induced nausea and vomiting. This     prospective study employs a parallel arm design, allowing for inclusion of patients with     pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients     receiving radiotherapy known to have a low or moderate emetogenic risk will receive every     other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of     rescue medication, and impact on quality of life will be monitored during and after radiation     treatment completion.   "
68532|NCT02388737|"     This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom     endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate     treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of     vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as     to determine the clinically recommended dose for vonoprazan for maintenance therapy in     erosive esophagitis.   "
68533|NCT02388724|"     The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus     lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA)     classification grades A to D at Week 8.   "
68534|NCT02388711|"     The goal of the project is to conduct a prospective, randomized-controlled clinical trial to     determine the extent to which the Coordinated-Transitional Care (C-TraC) program impacts     transitional care quality, patient cognition/function, caregiver stress and 30-day     rehospitalizations in patients with documented diagnoses of dementia discharged from the     hospital to the community.   "
68535|NCT02388698|"     The addition of concurrent chemotherapy to definitive radiation has improved the 5-year     survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV     DNA predates clinical recurrence and/or improves the accuracy of metabolic response on     FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally     advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and     overall survival. In addition plasma HPV can be used to monitor response and detect early     recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer     to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy     response on post-therapy FDG-PET scan at 3 months.   "
68536|NCT02388685|"     The goal is to test the ability to detect improved calf muscle perfusion and energetics in     PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will     be randomized to a 12 week home exercise program or no program (control).   "
68547|NCT02388542|"     The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri     Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these     worksites, quantify risk factor level in worksite populations and identify and train peer     mentors to deliver an educational intervention to improve life style and enhance medication     adherence among those at moderate to high risk of cardiovascular disease (CVD).   "
68537|NCT02388672|"     Coffee as one of the most favorite worldwide beverages comprises a variety of chemicals with     health benefits. Most investigations have so far focused on the beneficial effects of     caffeine but knowledge about non-caffeine coffee compounds such as chlorogenic acid (CGA) is     scarce. The reducing risk of a variety of diseases following CGA consumption has been     mentioned in recent basic and clinical studies. However, there is a lack of studies that     examine the behavioral effects of CGA. This study aims to fill this gap.      In a randomized double-blind study, the investigators test the acute effects of coffee     enriched with CGA or CGA supplement on physiological functions such as blood pressure, blood     glucose, and heart rate, and on psychological functions such as mood and cognitive     performance in 30 healthy adult subjects (18-40 years).      Participants will be allocated to an intervention plan using computer-generated random     numbers. Treatments comprise of (1) 6g decaffeinated (5 mg caffeine) coffee (250 ml) with     high total CGA (560 mg), or (2) 6g decaffeinated coffee (250 ml) with normal total CGA (224     mg), or (3) 6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee     bean extract with total CGA (560mg), or (4) 6g decaffeinated coffee (250 ml) with normal     total CGA and placebo, or (5) no treatment group. Upon arrival in the laboratory,     participants will complete a 24-hour food recall, a psychometric test battery, and mood and     cognitive performance tests. The tests will be repeated 40 min following CGA application,     which coincide with the approximated peak of CGA blood concentrations and at 120 min post     treatment. Blood pressure, blood glucose and heart rate recordings will be taken prior to     treatment and at 1, 30, 60, 90 and 120 min post-treatment. The response to GCE-enriched     coffee will be compared to GCE supplement for each of the groups of variables.   "
68538|NCT02388659|"     The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma     brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in IDH     mutated gliomas and IDH wild type gliomas.   "
68539|NCT02388646|"     The goal of this study is to explore the effectiveness of a commercially available,     over-the-counter knee brace in the conservative treatment of knee osteoarthritis.     Participants will either be fitted with a brace and told to wear it every day during normal     activities, fitted with the brace and given instructions on a set of quadriceps strengthening     exercises to complete twice daily, every day, or be given the exercise instructions, but not     fitted with a brace. Functional and subjective outcomes will be collected preoperatively and     at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing     alone versus a home exercise program, and whether the combination of those provides the most     therapeutic benefit to participants.   "
68540|NCT02388633|"     Severe hypercholesterolemia produced by conditions such as heterozygous familial     hypercholesterolemia is associated with multiple complications including premature     atherosclerotic disease. There is evidence that microvascular perfusion, particularly flow     reserve, in critical organs is limited due to abnormalities in plasma viscosity, abnormal RBC     deformability, and an imbalance between vasodilators and vasoconstrictors. There is little is     currently known about acute changes in microvascular blood flow and microvascular rheology     that occur in response to plasmapharesis which is used in some patients to lower critically     elevated cholesterol levels. Our research group has pioneered CEU methods for assessing     myocardial and skeletal muscle perfusion, and has previously demonstrated in pre-clinical     models that acute hyperlipidemia produces a reduction in microvascular RBC transit rate. In     this study, the investigators will assess acute changes in microvascular perfusion in     patients undergoing clinically-indicated plasmapharesis.   "
68541|NCT02388620|"     The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability     of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function     (based on Child-Pugh classification) as compared to demographically-matched control subjects     with normal hepatic function.   "
68569|NCT02387216|"     The purpose of this study is to determine whether the combination of MM-121 plus docetaxel or     pemetrexed is more effective than docetaxel or pemetrexed alone in regards to OS in patients     with heregulin-positive NSCLC.   "
68570|NCT02387203|"     The purpose of this study is to determine the impact of antibiotic therapy on the disease     progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).   "
68542|NCT02388607|"     Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is     characterized by clinical symptoms combining positive and negative symptoms and thinking     disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an     important part in adaptation of these patients in their every-day life, and to affect their     clinical symptomatology. Among them, there are deficits in sustained attention which are     associated with a difficulty for these patients to maintain efficiently their cognitive     activity on a source of stimulation or task. This basic attentional process is fundamental     for the efficiency of the overall of cognitive processes, and so for all behaviors directed     on an aim. The question of whether or not patients with schizophrenia have difficulty     sustaining attention is of high relevance, in the sense that it could undermine performance     on nearly any task and so provide a compelling causal explanation of many other impairments     observed in these patients. Yet it has not been conclusively answered in over four decades of     research. Consequently, the main objective of the protocol is to evaluate sustained attention     abilities in schizophrenic patients and to better understand the specific functioning of     cognitive and neural mechanisms underlying these abilities (attentional resources and     cognitive control mechanisms).   "
68543|NCT02388594|"     This is a triple cohort, open-label pilot study of the safety and antiviral activity of a     single infusion of autologous CD4+ T cells genetically modified at the CCR5 gene by Zinc     Finger Nucleases SB-728mR (ZFN Modified CD4+ T Cells) using electroporated mRNA with or     without the prior administration of two different doses of cyclophosphamide.   "
68544|NCT02388581|"     Aims: A nationwide study to prospectively validate        1. The complete histological and molecular remission rate for antibiotics as 1st-line          therapy for early-stage Hp-positive gastric pure (de novo) DLBCL        2. The durability of complete histological remission after antibiotics        3. The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in          prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL        4. The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in          Taiwan.        5. The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp          infection after antibiotics.   "
68545|NCT02388568|"     The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle     counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss     achieved during a prior 14-week dietary run-in.      14-week run-in. To qualify for randomization, participants must lose ≥5% of initial weight in     the 14-week dietary run-in. This loss will be achieved with the provision of weekly, group     lifestyle counseling, which includes a 1000-1200 kcal/day portion-controlled diet that     combines four daily servings of a liquid diet (HMR shakes) with an evening meal of a     frozen-food entree (and a fruit and vegetable serving). More than 70% of participants are     expected to achieve the 5% criterion loss during the 14-week run-in.      A total of 182 women and men with a BMI ≥33 and ≤55 kg/m2, without co-morbidities, or ≥30 and     ≤55 kg/m2 (with a co-morbid cardiovascular disease (CVD) condition) will be enrolled in the     4-month run-in period. Prior to enrollment, all participants will have a history, physical     exam, electrocardiogram (EKG), and appropriate blood tests. They will attend weekly group     sessions for 14 weeks. Participants will have a brief medical visit at week 8 to check their     health and blood tests will be repeated. The investigators anticipate that 136 (75%)     participants will lose 5% or more of initial weight and qualify for randomization.     Participants who do not lose 5% will be provided a list of weight loss resources (e.g., other     programs) to facilitate their continued weight management.      12-month randomized trial with lorcaserin. A total of 136 participants who have lost 5% or     more of initial weight in the run-in period will be randomly assigned, in double-blind     fashion, to lorcaserin (10 mg BID) or matching placebo. To be eligible, participants must     have a BMI (after prior weight loss) ≥30 kg/m2 (without co-morbidities) or greater than or     equal to ≥27 (with a co-morbidity). Randomization will be performed by the Investigational     Drug Service at the Hospital of the University of Pennsylvania. Prior to randomization, all     participants will complete a second brief history and physical examination, as well as an EKG     and blood tests. Medication will be dispensed at the randomization visit and at brief medical     visits that follow. Over the 1 year, all participants will participate in 16 group lifestyle     modification classes designed for weight loss maintenance, approximately half of which will     be delivered by group conference call.      Primary outcome measure. The primary endpoint is change in body weight (in kg), as measured     from randomization to month 12. The co-primary end-point is the percentage of participants in     the two groups that, at month 12, maintained the ≥5% reduction in body weight achieved during     the 14-week dietary run-in period. Secondary efficacy endpoints include changes in CVD risk     factors, glycemic control, and quality of life, as measured from randomization to month 12.     Exploratory endpoints include changes in these CVD and related outcomes, as measured at the     start of the 14-week run-in period to month 12. The investigators also will examine the     percentage of participants in the two groups who at month 12 achieved losses of ≥5%, ≥10%,     and ≥15% of initial weight, as measured from the start of the run-in period.      Safety endpoints will include physical examination, electrocardiogram, adverse events (AEs),     standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity     Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9).      Statistical Analysis. The planned sample size of 136 participants, with a 1:1 randomization     ratio, assumes a 20% drop-out rate (at month 12) and was estimated to be adequate to evaluate     the primary endpoint with power ≥90% (P=0.05, two-sided test). The investigators predict a     difference in weight change between the two groups (from randomization to month 12) of 4 kg     (SD=3.5). Pre-specified data analysis will be performed on the full analysis set, comprising     all randomized individuals exposed to trial drug with at least one post-randomization weight     assessment.   "
68546|NCT02388555|"     Currently there is paucity of information on the prevalence of pre-operative coronal     imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical     outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to     propose a novel classification system and to investigate whether pre-operative coronal     imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were     recruited.   "
68549|NCT02388516|"     There is a growing body of data suggesting that vitamin D modulates the host's immune     response to acute respiratory infection (ARI). The primary aim of this study is to determine     whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of     microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh.     Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B)     incidence of clinical ARI (without the need for positive microbiology), and C) quantitative     density of pneumococcal carriage. Infants will be followed from birth until 6 months of life.     Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed     Description' section), nasal swab specimens will be collected. Respiratory samples will be     analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza     A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza     types 1, 2, and 3) plus quantitative density of S. pneumonia.   "
68550|NCT02388503|"     This study is designed to identify the minimal effective tested dose of fruit extract     consumed with a bread which provides a reduction in venous post-prandial blood glucose     compared to a reference bread.   "
68551|NCT02388490|"     This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to     evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.   "
68552|NCT02388477|"     The purpose of this study is to examine healing after rotator cuff repair in subjects either     treated with Doxycycline or placebo post-operatively.   "
68553|NCT02388464|"     This is a Phase 1, single-center, randomized, double-blind, single ascending dose,     placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart     failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability,     and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).   "
68554|NCT02388451|"     15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of     MCI and who provide informed consent will undergo cognitive and functional assessment to     confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive     Impairment Computerized Assessment Battery will be performed. Subjects will then participate     30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams     testing will be repeated after 15 sessions and at completion of the study.   "
68555|NCT02388438|"     This study evaluates the demineralized bone matrix in Hallux valgus.   "
68571|NCT02388412|"     Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising     results for detecting vulnerable plaques in some pilot studies.      In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for     non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).   "
68734|NCT02386098|"     The purpose of this study is to evaluate whether the combination of BMS-955176 with     atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious,     safe, and well-tolerated in HIV-1 infected treatment experienced adults.   "
68556|NCT02387385|"     Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood     flow and oxygen supply to the foetal brain at the time of birth. Every year, approximately     one million babies die from neonatal encephalopathy in low and middle-income countries and a     quarter of these deaths occur in India.      In the past decade, a number of clinical trials in high-income countries has shown that     cooling therapy along with optimal neonatal intensive care reduces death and neurodisability     after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after     neonatal encephalopathy in all high income countries, including the UK.      Although the burden of neonatal encephalopathy is far higher in low and middle-income     countries, the safety and efficacy data on cooling therapy from high income cooling trials     cannot be extrapolated to these settings, due to the difference in population co-morbidities     and sub-optimal neonatal intensive care.      The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6     hours of birth and continued for 72 hours reduces death or neurodisability at 18 months after     neonatal encephalopathy in public sector neonatal units in India.      A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from     the participating centres in India over an 18 to 24 month period. The babies will be randomly     allocated to whole body cooling or usual care. The cooling therapy will be achieved using an     approved cooling device (Tecotherm) that is already in clinical use in the UK and in India.     MR imaging and spectroscopy will be performed at 1 week of age to examine the brain injury.     Neurodevelopmental outcomes will be assessed at 18 months of age. Primary outcome measure is     death or moderate/severe neurodisability at 18 months.   "
68557|NCT02387372|"     The purpose of this study is to evaluate the pharmacokinetics and lung penetration of     intravenous Ceftolozane/tazobactam in critically ill participants.   "
68558|NCT02387359|"     This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,     parallel-group clinical trial with 12 weeks of study drug therapy.   "
68559|NCT02387346|"     The role of the cerebello-thalamo-cortical loop in the generation of tremor, gait impairments     and postural instability has been made evident. The current study will use a Magstim Rapid 2     to deliver rTMS with the aim of modulating the activity in the vermal/paravermal region of     the cerebellum, and consequently the cerebello-thalamo-cortical pathway. Analysis of the     effects of an acute session of stimulation will be made to determine the therapeutic     potential of the protocol. Motor symptom improvement will be assessed immediately following     stimulation to detect motor symptom improvement up to one hour following stimulation,     providing insight into the effectiveness of the protocol to produce benefits which outlast     the period of stimulation.      Participants will each receive one session of stimulation in the ON state of medication. A     pre-assessment will be performed before beginning the session and a post-assessment will be     performed immediately following stimulation. There will be two groups, which will both     undergo the exact same protocol, however one group will receive real stimulation, and one     group will receive sham stimulation.   "
68560|NCT02387333|"     The aim of this clinical trial is to investigate the safety and efficacy of prophylactic mesh     on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a     randomized controlled fashion.   "
78685|NCT02255929|"     The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery     for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.   "
68564|NCT02387281|"     Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD)     and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting <30     seconds) episode of absence or a greatly reduced forward movement of the feet despite     intention to walk. It typically occurs when patients initiate gait (so-called start     hesitation) and when attempting to turn. It is a leading cause of falls and often results in     a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes     social isolation and poor quality of life.      FOG is one of the least understood features of PD. It possibly may develop independent of the     other motor features of the disease, and be caused by specific pathological changes in the     brain. Previous studies on FOG have shown conflicting information and have not lead to clear     understanding of the pathophysiology. One key reason for this is that there appears to be     multiple subtypes which have rarely been taken into account.      The purpose of this study is to show that different types of FOG exist and to see if there is     a connection to cognitive differences or gait patterns.   "
68565|NCT02387268|"     The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a     poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.   "
68566|NCT02387255|"     The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to     determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is     a more sensitive and superior method of determining the risk for rupture of AAA based on     stiffness estimates when compared to the current, crude method of assessing risk based on     measurement of the diameter of the aneurysm. The investigators will also validate the     stiffness estimates against gold standard i.e. mechanical testing and histopathology only AAA     patients undergoing AAA surgery.   "
68567|NCT02387242|"     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium     tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood     Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of     rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).   "
68568|NCT02387229|"     This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the     efficacy and safety of rivaroxaban as compared to acetylsalicylic acid in reducing stroke,     transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF     and with low risk of stroke.   "
68572|NCT02388399|"     In this study, the investigators sought to evaluate the feasibility of estimating external     hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from     pressure wire pullback tracing.      In addition, the investigators will also evaluate detailed plaque geometry and vulnerability     using optical coherence tomography along with the hemodynamic stress.   "
68573|NCT02388386|"     The investigators aim to develop a novel and wireless method for monitoring medication     adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus     Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to monitor     medication compliance. The edible sensor has at its core a silicon-based integrated circuit     measuring 1.0 mm x 0.45 mm and is imbedded on a pill. Once ingested, this circuit is     activated by gastric acid resulting in an electrochemical redox reaction and an electrical     charge that is transmitted to a patch worn over the abdomen and wirelessly to a portable     device such as a smart phone. This strategy of medication adherence differs from conventional     adherence monitoring including pill counting and patient-recall by precisely tracking     medication ingestion.   "
68574|NCT02388373|"     The aim of this study is to compare two licensed asthma inhalers and to then evaluate the     safety of reducing treatment when patient's asthma is in control. The inhalers used in this     study are the Seretide® 250 Evohaler®, which is widely used in UK, and a recently licensed     inhaler called Flutiform®. National guidelines recommend that asthma medication should be     increased when patients are experiencing worsening of their asthma, and reduced when asthma     is in control. However, it is likely that in daily clinical practice some patients are     over-treated. It is therefore necessary to conduct more studies which demonstrate that     reducing treatment dosage can be done safely.      This study has two phases. In the first phase the investigators aim to recruit 224 patients     through approximately 40 clinics in the UK and Ireland. One third of these patients will be     selected in random to use the high dosage Seretide® 250 Evohaler® and two thirds will use     high dose Flutiform® 250 inhaler for 12 weeks. At the end of phase 1 the investigators will     compare how well asthma was controlled between the two groups.      After phase 1 those patients who used Flutiform and did not have any problems with their     asthma can participate in phase 2. In phase 2 half of the patients will stay on high dosage     Flutiform 250 and half will be switched to the medium dosage Flutiform 125 inhaler. At the     end of phase 2 the investigators will compare asthma control between the two groups.      This study will be conducted by Research in Real Life Ltd (Cambridge, UK) with partial     funding from Napp Pharmaceuticals Ltd. The estimated total duration of the study is 18 months     and each patient will spend a maximum of 6 months in the study.   "
68575|NCT02388360|"     The purpose of this study is to determine the influence of topical prostaglandin analog (PGA)     medication on corneal biomechanical properties in patients undergoing PGA treatment for     open-angle glaucoma.   "
68576|NCT02388347|"     To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects     and healthy adult female subjects of non-childbearing potential.   "
68598|NCT02388061|"     Patients presenting to the emergency department with acute ischemic stroke, who are are     eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be     assessed for major vessel occlusion to determine their eligibility for randomization into the     trial. If the patient gives informed consent they will be randomised 50:50 using central     computerised allocation to intravenous alteplase or tenecteplase before all participants     undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label,     blinded endpoint (PROBE) design.   "
68604|NCT02387983|"     The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole     tablets in Chinese participants at high risk for invasive fungal infections. Neutropenic     participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic     syndromes will be enrolled in the study.   "
78686|NCT02255916|"     The purpose of this study is to determine the effects of live sound-bed music on     physiological and psychological parameters in staff of a hospital oncology ward.   "
68577|NCT02388334|"     Half the MS patients require a natural (non professional) caregiver's support for daily     living activities and this level of investment increases with the degree of disability.      The caregiver's role is an essential key factor in the therapeutic alliance between the     patient and heath professionals. The impact on the natural caregivers' Quality Of Life (QOL)     and their expectations for the global quality of management are not documented, notably     because of the lack of adapted tools.      The aim of the investigators' project is to develop, from the caregivers' point of view, a     standardized questionnaire evaluating 1) their QOL as related to the disease of the assisted     and 2) their expectations concerning the global quality of professional management (care,     coordination, information...).      1) their quality of life (QOL) as related to the disease of the assisted and 2) their     expectations concerning the global quality of professional management (care, coordination,     information...).      The original tool validated will complete the palette of those that the investigators are     developing to evaluate the quality of care of MS patients according to different dedicated     organizations (formal networks or not, focused on the patients or professionals).   "
68578|NCT02388321|"     Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for     the treatment of moderate to severe pain in pediatric patients in the emergency department.   "
68579|NCT02388308|"     Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men     receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate     to kill cancer cells whilst minimizing the dose given to surrounding normal tissues, such as     the bladder or the rectum. Radiation is delivered in a number of daily treatments which are     called 'fractions'. The position of the prostate varies each day and during the radiation     delivery. To accurately aim the radiation the prostate needs to be located before daily     treatment. Clarity is an ultrasound image guidance system that locates the prostate and     monitors its position during treatment. Ultrasound does not give a radiation dose, is     non-invasive, provides fast imaging and can easily visualise soft tissues. Before Clarity is     implemented the investigators wish to ensure that it can accurately locate and monitor the     prostate by comparing Clarity with marker-based techniques in 24 patients. Patients receive     markers as part of other trials which are currently recruiting at The Royal Marsden (for     example, patients in the DELINEATE trial and the PACE trials receive implanted gold markers     and patients in the PROSPARE trial have received electromagnetic markers). Patients who have     received or will be receiving markers as part of other studies will be asked to also to take     part in this study. This means that there will be no additional intervention for patients as     a result of this study. Clarity will be considered a safe and effective imaging system if the     mean and standard deviation of the differences between Clarity measurements and marker     measurements, of prostate position, are less than 1mm. It is possible that markers will     influence the Clarity measurements. To find out if this happens, the mean and standard     deviation of Clarity measurements in a group of 24 patients without markers to the group with     markers will be compared.      Primary Aim: To evaluate the accuracy of Clarity ultrasound image guidance system for     prostate motion estimation during treatment (intra-fraction), by comparison with implanted     marker-based image guidance techniques.      Primary Hypothesis: Clarity can be safely used to deliver radiotherapy using similar (within     1mm) treatment margins to those that would be employed if fiducial markers based image     guidance techniques were used.   "
68580|NCT02388295|"     AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability,     randomized trial, in patients with Multiple System Atrophy.   "
68581|NCT02388282|"     Dinamic intrinsic PEEP is   "
68582|NCT02388269|"     A randomized, sham-controlled, single-centre pilot investigation designed to compare two     parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment in subjects     with FGIDs.   "
68626|NCT02387697|"     The purpose of this study is to assess the efficacy and safety of implanting an Edwards     Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein)     on clinical variables, exercise tolerance and well being in patients with severe tricuspid     regurgitation and signs of right heart failure.   "
68583|NCT02388256|"     Background:      Patients who undergo laparoscopic surgical resection of colorectal cancer may experience     various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation     of daily activities (e.g., walking capacity). There is also a risk of post-operative     complications and a prolonged hospital stay due to complications. Patients who underwent     surgical resection may have experienced chronic pain, anxiety/depression, or diminished     quality of life. The physical, psychological, and functional aspects of patients' disorders     imply the necessity of multidisciplinary care, including complementary or traditional     medicines such as acupuncture. This study aims to assess whether acupuncture treatment,     combined with an enhanced recovery program after surgery in an inpatient care setting is     effective than only an enhanced recovery program after surgery.      Objective:      To assess the effectiveness and safety of acupuncture combined with an enhanced recovery     program after surgery to reduce postoperative symptoms and improve functional recovery and     the patients' quality of life.   "
68584|NCT02388243|"     The purpose of the two RCT registered here is to determine whether clinicians trained on the     Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention     (BI) through the NextGenU.org model of training are able to deliver effective brief     intervention for risky level of alcohol use. It is one study part of a larger program of     research.      The investigators hypothesize that the NextGenU.org model of online training with mentor and     peer activities is an effective way to train clinicians to deliver the ASSIST-linked brief     intervention. The investigators hypothesize that eligible participants receiving the brief     intervention will decrease their alcohol consumption and experienced improved health and     social outcomes more than those receiving only screening results and written information     (p<0.05). The investigators hypothesize the level of decrease in alcohol consumption will be     similar to that of trials conducted in high-income countries (HIC).   "
68600|NCT02388035|"     Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and     the changes in the microbiological characteristics reported in the last years are impacting     the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively     studied antibiotic for this infection. It is considered to be one of the first choice     antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous     cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms     have been increasingly reported especially to cefotaxime and its effect on the clinical     outcome in treating SBP.   "
68601|NCT02388022|"     The purpose of the study is to gather clinical and radiographic outcome data from patients     who have undergone treatment with an expandable interbody spacer.   "
68602|NCT02388009|"     This is a phase I, single-blind, randomized, placebo-controlled, single-center study in     healthy subjects using a staggered approach to dosing.      30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without     adjuvant or placebo.   "
68603|NCT02387996|"     The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor     size in subjects with metastatic or unresectable bladder cancer.   "
68585|NCT02388230|"     Around 20% of women who receive breast radiotherapy (RT) experience moderate to severe breast     hardening and shrinkage. These side-effects have been shown to be important factors     influencing quality of life after breast radiotherapy. It is thought that the likelihood of     developing these side-effects is related to the presence of underlying genetic differences in     patients. In order to identify these genetic differences, the severity of side-effects needs     to be accurately measured. Currently, clinical assessments are conducted by a clinician but     this is not specific enough to be able to relate development of breast shrinkage and     hardening to genetic differences. For example, clinical assessment often fails to distinguish     between hardness due to swelling (known as oedema) and hardness due to generalised     radiation-induced scarring (known as fibrosis). Ultrasound techniques, however, may be able     to help quantify and characterise radiotherapy-associated changes in breast tissue allowing     for better correlation with genetic abnormalities. Once genetic changes can be identified,     adjustment of breast RT treatments (or add drugs) to help reduce side-effects in women at     higher genetic risk of side-effects may be possible.      This study tests the ability of two forms of ultrasound, shear-wave elastography (USE) and     ultrasound backscatter spectroscopy (UBS), to quantify and characterise breast shrinkage and     firmness with a view to using these techniques to measure the late side-effects of breast RT     to study the underlying causes of radiotherapy toxicity.      Principle research question: Can a new ultrasound technique (shear wave elastography) measure     radiation-induced side-effects in women who have received breast radiotherapy?   "
68586|NCT02388217|"     The objective of the current study is to prospectively assess the effect of cannabis on pain     and functional outcomes in a large group of patients with chronic pain.   "
68587|NCT02388204|"     Although DBS improves patient's quality of life advanced Parkinson's patients (PD) by     addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still     worsen over time. Postural problems, frequent falls, freezing of gait impairment and other     locomotion difficulties still remain as important causes of disability and incapacity. Novel     therapeutics approaches are needed to restore quality of life (QoL).      This study aims to explore the effects of spinal cord stimulation in locomotion, falls and     freezing of gait in advanced PD patients.      Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a     prospective study for six months.      Changes in locomotion capacity and freezing of gait rating will be the primary out come.     Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always     comparing the status before, one, three and six months after stimulation was initiated. A     double blind trial will be performed within three months of follow up (high X low frequency     stimulation).   "
68588|NCT02388191|"     The purpose of this study is:        1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on          a 0-10cm visual analogue scale compared to placebo (primary outcome).        2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum          placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale          compared to placebo (secondary outcomes).        3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD          insertion.      Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD     insertion will lead to a reduction in pain scores associated with IUD insertion compared to     placebo.   "
68589|NCT02388178|"     This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to     evaluate remineralization of early caries lesions.   "
68590|NCT02388165|"     The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent     postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal     fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective     spinal surgery.   "
68591|NCT02388152|"     The purpose of this study is to determine if multiple immunizations with Lu AF20513 is     tolerable and safe in patients with mild Alzheimer's disease.   "
68592|NCT02388139|"     Aims        -  assessment of renal artery stenosis incidence in consecutive AMI patients included in          the Romanian National Programme of Primary Percutaneous Revascularisation;        -  generating a cardio-renal-metabolic profile in patients with renal atherosclerotic          disease;        -  creating a local registry (based on European CARDS percutaneous interventional          registries) which also includes renal, metabolic and vascular data;        -  reporting long-term follow-up data on major cardiac adverse events (MACE) in the study          group.   "
68593|NCT02388126|"     Prostate cancer has been the most common neoplastic disease in men in Finland over the last     ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate     cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.     Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)     guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed     instead of targeted TRUS biopsy. While, as many as 47% of the ultra-sound guided biopsies may     be false negative and biopsies carry a risk of increase in complications, there is an     increasing interest in developing more accurate non-invasive imaging modalities.      This study will enroll 150 men with previous negative biopsies and clinical suspicion of     prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal     examination (DRE) or patients in active surveillance due to low risk prostate carcinoma.     Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla     (T) magnetic field using surface coils will be used to non-invasively predict the presence or     absence of prostate cancer. In addition to routine 12-core TRUS biopsies, targeted TRUS     guided biopsy based on MRI findings will be performed.   "
68594|NCT02388113|"     This study will compare two interventions with the same exercise intensities and caloric     expenditure but with different exercise frequency, on metabolic control and other risk     factors in individuals with type 2 diabetes.   "
68595|NCT02388100|"     This pilot study is planned to validate the comparability of HbA1c results obtained from     whole blood collection via venous phlebotomy versus a capillary collection of whole blood.     The participant will self-collect capillary blood into HbA1c prep vials containing a buffer;     these prep vials will be sent to the CBL at ambient temperature via US Postal System (USPS)     mail. The feasibility of self-collection of these capillary samples by GRADE participants     will also be evaluated.   "
68605|NCT02387970|"     Dental implants are a widely used treatment option for the replacement of lost teeth due to     trauma or oral diseases. The original protocol for placement of dental implants in edentulous     spaces in the maxilla or the mandible was introduced more than thirty years ago and called     for a two-stage approach, i.e., surgical placement of submerged dental implants and     subsequent uncovering with abutment connection, prosthesis fabrication and functional loading     approximately 6 months after. Today, the time between surgery and loading in a two-stage     protocol has been commonly abbreviated to 3-4 months, while immediate implant     provisionalization has emerged as a reliable and predictable option in cases of adequate     osseous support, having similar survival and success rates to the two-step procedure.     Comparison of histological healing has demonstrated no significant differences in bone to     implant contact between implants surgically placed according to a two-stage protocol and     those immediately provisionalized. However, substantial variability was noted among the     clinical protocols used in the studies carried out so far, and additional well-designed     randomized controlled trials (RCTs) are needed to fully appreciate the clinical outcomes of     immediate and early loading protocols.      The design of dental implants is a subject of continuous improvement, and implant     manufacturers regularly introduce new products the use of which may result in accelerated     soft and hard tissue healing, increased initial implant stability, and enhanced esthetic     outcomes. The purpose of this randomized, controlled trial is to compare treatment outcomes     when using a newly-introduced dental implant (NobelParallel™ CC) in a one-stage or a     two-stage protocol. This new implant has the same titanium oxide surface coating (TiUnite®)     and the same design principles of the parallel-walled NobelSpeedy Groovy™ implants, and an     internal conical connection. The implant is marketed under the premarket notifications     K050406 and K073142 (510(k), Food and Drug Administration).   "
68606|NCT02387957|"     To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with     anti-VEGF therapy.   "
68607|NCT02387944|"     The purpose of this study is to assess coagulation and platelet function in children with     congenital heart disease, measured with a bedside device (thromboelastometry and impedance     aggregometry).      The investigators also aim to determine if this device detect post-cardiopulmonary bypass     clotting derangements and may help to manage bleeding in this population.   "
68608|NCT02387931|"     The purpose of this study is to determine whether dietary supplementation with Vitamin D or     Fish Oil can help to reduce physical and emotional symptoms in adolescent girls with     endometriosis.   "
68609|NCT02387918|"     Tonsillectomy is one of the most frequently performed surgical procedures in children. It     remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk     of bleeding, and dehydration due to impaired oral intake. Current medications for POV have     limited efficacy and may even be associated with potential side-effects. Non-pharmacological     techniques such as acupuncture has been investigated as alternatives to antiemetics and as     additional treatment modalities for POV.   "
68610|NCT02387905|"     The goal of this clinical research study is to learn whether using body cement on the largest     part of the vertebra (a procedure called vertebral body cement augmentation) can help to     prevent a fracture following stereotactic spinal radiosurgery. Researchers also want to learn     if the procedure can lessen pain and improve quality of life in patients receiving this     surgery.   "
68611|NCT02387892|"     This study is being done to test if adding vitamin D to cheese and yogurt products will help     children further improve their vitamin D intake. All children will be given a six month     supply of the milk products. One group will receive yogurt and cheese products already sold     in stores, while the other group will receive yogurt and cheese products with added vitamin     D. This will show if milk products with added vitamin D help maintain vitamin D intake and     child health.      The investigators are asking children 2 through 8 years old to participate. Children must not     have any medical conditions that affect their bones or vitamin D levels. They must not be     taking vitamin D supplements or medications that affect bone. This study will last for 6     months. The investigators expect 60 children from the Montreal area will participate in this     study.      Children will be randomly placed in one of the two study groups. There will be an equal     number of children in each group. All groups will go through the exact same procedures during     the study; the only difference between groups will be the amount of vitamin D in the milk     products they will consume each day. Families will not know which group their child is in     until the study is complete. Children will continue to drink their regular milk at home and     the investigators will provide flavoured yogurts and cheese to eat every day for the entire 6     month study. Families will be given a fresh supply of the yogurt or cheese products every 4     weeks along with instructions.      There are 3 study meetings for the parent and child to attend which take place at the Mary     Emily Clinical Nutrition Research Unit. The clinic is located on the Macdonald Campus of     McGill University in Ste. Anne-de-Bellevue, QC. The first visit is at the start of the study,     the second is at the end of 3 months and the last visit is at the end of the 6 month study.   "
68612|NCT02387879|"     CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety     study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in     Turkey.      The study is anticipated to last for approximately 8 years. Recruitment period will continue     until 500 subjects have commenced the third cycle of treatment with lenalidomide.   "
68613|NCT02387866|"     This is a single ascending dose, open-label study that will evaluate the pharmacokinetics and     safety of the AG-221 compound in normal, healthy volunteer male subjects (both Japanese and     Caucasian).   "
68614|NCT02387853|"     An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week     trial in adolescent subjects with plaque psoriasis.   "
68615|NCT02387840|"     This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in     children, adolescents and young adults (AYA) with and without brain tumors. This study will     also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that     affects the growth of nervous system cells. Further, it will explore potential ways of using     of MRF signal measurements in children, adolescents, and young adults with brain tumors,     including tissue characterization, looking at whether the treatment was effective, and     finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and     potential applications of MRF, this study will recruit up to 80 subjects but will stop once     10 subjects have usable data in each of six groups.   "
68616|NCT02387827|"     The purpose of this present study is to determine if a daily walking program of 50 continuous     minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight,     abdominal fat mass deposition and cardiometabolic measures in overweight and obese women     receiving a low calorie diet for 24 weeks.   "
68617|NCT02387814|"     The study involves a single dose of a study drug called abemaciclib taken by mouth. The     purpose of this study will be to measure how much study drug gets into the blood stream and     how long the body takes to get rid of it when given to participants with mild, moderate, or     severe liver impairment compared to healthy participants. In addition, the tolerability of     the study drug will be evaluated.      This study will last approximately 3 weeks for each participant, including check-in and     follow-up.   "
68618|NCT02387801|"     To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque     psoriasis and to document the same using sequential photographic images.   "
68619|NCT02387788|"     Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778     administered twice daily for 84 days in subjects with macular edema due to RVO.   "
68620|NCT02387775|"     This is a prospective, interventional study aiming to assess the effectiveness of the     Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest     patients. In addition, observed adverse events during ECD use, ease-of-use, nurse     satisfaction and patient outcomes will be examined.   "
68621|NCT02387762|"     This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and     efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.   "
68622|NCT02387749|"     A debilitating consequence of diabetes mellitus (DM) is neuropathy which globally affects     between 20 -30% of diabetic patients and up to 50% in other studies. The incidence of     diabetic neuropathy (DN) is estimated to be up to 45% for type 2 diabetic patients and 59%     for type 1diabetic patients in USA.(DN) is the most common complication of DM. The risk of DN     rises with age, duration of DM, and vascular disease. It is Characterized by damages in the     arms and legs. The pathophysiology of DN is promoted by several risk factors: micro vascular     disease, neural hypoxia, and hyperglycemia-induced effects At the molecular level, the     primary cause of diabetic complications is known to be hyperglycemia, which disrupts cellular     metabolism by the formation of reactive oxygen species (ROS).In the aspect of nerve     functions, ROS formation increases neuron's susceptibility to damage. In addition,     hyperglycemia impedes production of angiogenic and neurotrophic growth factors, which are     necessary for normal function of neurons and glial cells and maintenance of vascular     structure .The most common presentation of nerve damage due to the effects of hyperglycemia     is neuropathic pain. (DN)may cause foot deformities such as hammertoes and unnoticed sores     and infections in the numb areas of the foot. Improperly treated infection frequently extends     to the bone and requires amputation of the foot.No definitive disease-modifying treatments     have been to reverse DN. The current treatment focuses on tight glycemic control which can     reduce potential risk factors for further nerve damage and DN-associated pain management. In     many studies, deficiency of neurotrophic factors and lack of vascular support have been     regarded as key factors in the development DN .Mesenchymal stem cells (MSCs) are particularly     attractive therapeutic agents because of their ability to self-renew, differentiate into     multi lineage cell types , and locally secrete angiogenic cytokines, including basic     fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) .These factors     were reported to prompt neovascularization and have support for neural regeneration.MSC     transfusion was reported to be a therapeutic agent in the treatment of Cardiovascular     disease. Similarly, it was plausible that MSCs may also be an effective therapeutic agent for     the DN treatment through the paracrine effects of bFGF (Shibata et al., 2008) and VEGF and     their potential to differentiate into neural cells such as astrocytes, oligodendrocytes , and     Schwann cells.The adherent nature of MSCs makes them easy to expand in culture and an     attractive candidate to use in cell therapy. Also, MSCs are particularly attractive     therapeutic agents because of their ability to self-renew, differentiate into multi lineage     cell types, and locally secrete angiogenic cytokines, including (bFGF) and VEGF. Therefore,     cell therapy has recently emerged as an attractive therapeutic strategy to meet the needs of     both neurotrophic and vascular deficiencies of DN.In electrodiagnostic studies, nerve     conduction velocity and magnitude are measured by electrically stimulating nerves. Proper     diagnosis of DN depends on the pattern of sensory loss, reflex test, electrodiagnostic     studies, and imaging   "
68623|NCT02387736|"     Standard one-year dialectical behaviour therapy (DBT), which has four components, is an     effective treatment for people with borderline personality disorder. However, such DBT     programs are in short supply and costly, resulting in long wait lists. In practice, DBT is     often reduced in length or intensity. This study will determine whether shorter DBT treatment     is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be     randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two     years. Rates of suicidal and self-harm behaviours, use of health care and general     psychological functioning will be examined.   "
68624|NCT02387723|"     The present aim is to perform at small clinical safety trial in heart failure patients with     allogeneic adipose tissue derived mesenchymal stem cells.   "
68625|NCT02387710|"     Obstructive sleep apnea (OSA) is common and has major health implications but treatment     options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep     (called slow wave sleep), potentially via an increase in the stimulus required to arouse     from sleep. Here the investigators test the idea that the medication called tiagabine     improves slow wave sleep and reduces OSA severity. The investigators will also test whether     tiagabine raises the arousal threshold (more negative esophageal pressure), and whether     detailed OSA phenotyping characteristics can predict the improvement in OSA severity with     this intervention.   "
68627|NCT02387684|"     The most important method to slow down and stop the liver disease progression in patients     with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response     during treatment or obtain sustained viral response after treatment. The aim of the therapy     with interferon is make patients obtain immune control to HBV defined as sustained viral     response after treatment, however, most patients can't get this target after 48 weeks of     interferon treatment, and some patients need extended treatment in clinical practice to     enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this     cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic     hepatitis B patients will be evaluated.   "
68628|NCT02387671|"     The long-term goal of this research is to develop, evaluate and implement effective mHealth     technology interventions that improve cancer management outcomes by changing lifestyle     behaviors among urban health- disparity facing populations. To accomplish this goal, the     investigators will need to determine the feasibility and preliminary efficacy of an     intervention in which breast cancer survivors receive counseling about lifestyle behaviors     (weight, nutrition, and physical activity) from a health counselor trained in evidenced-based     behavioral counseling methods.   "
68629|NCT02387658|"     1. To perform an observational analysis to determine if mean translesional gradient          measurements (TLG) are associated with differences in clinical outcomes in patients with          femoropopliteal arterial disease and claudication.        2. Hypothesis: Patients stratified by a residual translesional gradient </= 11 mmHg after          peripheral revascularization or angiography alone will have better clinical outcomes          than patients with TLG > 11 mmHg as assessed by six minute walk (6MW), walking          impairment questionnaire scores (WIQ), ankle brachial index and need for repeat          procedure at 6 months.   "
68630|NCT02387645|"     The current pilot study aims at answering the scientific question, whether exfoliated cells     from Endometrium Carcinoma (EC) can be detected in the lavage fluid from the uterine cavity     and proximal fallopian tubes with the same sensitivity as in specimen from liquid-based     cervical cytology. If this turns out to be the case, earlier detection, particularly of type     II EC should be possible.   "
68631|NCT02387632|"     Humidified High Flow Nasal Cannula (HHFNC) is a new modality of respiratory support for     children with respiratory failure. Despite its extensive use in pediatric and adult     population, the exact mechanism of work of HHFNC is not fully explained.The objective of the     investigators' research project is to determine the relationship between the amount of airway     pressure that can be delivered at specific flow levels of HHFNC. This information will allow     the investigators to use HHFNC in a much more informed and safe manner.   "
68632|NCT02387619|"     A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic     drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers   "
68633|NCT02387606|"     The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ     53718678 compared to placebo in healthy adult participants infected through inoculation with     respiratory syncytial virus (RSV)-A Memphis 37b virus.   "
68634|NCT02387593|"     Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The     cumulative risk of developing CRC is about 6% lifelong.      The benefit of screening colonoscopy depends on the detection and removal of all adenomas,     however, some of these may be difficult to detect.      The endocuff (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the     image viewing of the mucosa during colonoscopy procedure.      There is insufficient evidence of the usefulness of endocuf   "
68635|NCT02387580|"     This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male     subjects and female subjects of non-childbearing potential.   "
68636|NCT02387567|"     The purpose of this study is to investigate the effects of a treatment involving the     application of lidocaine injected on the low back area for pain control. The study will     compare this form of treatment with other options such as physical exercises or pain killer     medication, different measurements are going to be used to quantify the response to each of     these treatments.   "
68637|NCT02387554|"     The purpose of this study is to investigate the pharmacokinetic interaction and safety     between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy     male volunteers   "
68638|NCT02387541|"     To investigate the effects of total knee replacement is harmful to Postoperative cognitive     dysfunction   "
68639|NCT02387528|"     High demands put on workers nowadays have contributed for an increase on the vulnerability     and the stress levels, with severe consequences for the health (Sandim, 2008). One of the     main health conditions today is the Burnout Syndrome - or professional exhaustion (Salanova     and Llorens, 2008), with harmful consequences for individuals and organizations. The level of     dedication to the tasks in which the frustrations are faced more strongly can determine what     type of burnout would be developed ( frenetic, under-challenged or worn-out), affecting     the health condition. In late 1970s, mindfulness began to be studied as a behavioral     intervention in mental health. Current evidence suggests that the state / mental trait     mindfulness is positively associated with a variety of mental health indicators. The     potential applicability of mindfulness in health services is great. Besides the effects for     patients, health professionals also can have benefits. The consensus is that a greater number     of mental health interventions need to be evaluated and implemented and it is possible that     mindfulness can fit this need as a new technology in health care. There is a gap in the     literature on the relationship of different clinical types of burnout and its association     with different psychological constructs related to health, particularly in relation to the     mental state of mindfulness and, in particular , addressing health professionals. Better     understand this association will enable the improvement of existing and development of new     interventions, geared to the specific needs of the population of health professionals,     especially for professionals of Primary Health Care (PHC) , the object of this study. Thus,     the general objective of this study is to assess the effect of a mindfulness-based     intervention for primary health care professionals in the city of Porto Alegre, evaluating     the behavior of a questionnaire for clinical subtypes of burnout (BCSQ -36), other variables     of psychological well -being, depression and anxiety symptons, activity and sleep patterns,     measuring before and after the intervention, from a randomized controlled trial.   "
68640|NCT02387515|"     This clinical pilot trial will investigate the effects of technology-supported exercise     therapy for chronic non-specific low back pain. Patients will follow an intensive     rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that     is supported by technology. The technological system consists out of motion tracking sensors     that register the movements and position of the lumbar spine.   "
68762|NCT02385734|"     This study hypothesized that Concentrated Growth Factors'(CGF) placement together with     Coronally Advanced Flap (CAF) may enhance the healing of soft tissues. Therefore, the aim of     this study was to determine the clinical effect of CGF combination with CAF compared to CAF     alone in the treatment of adjacent multiple gingival recessions.   "
68641|NCT02387502|"     Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three     axes are not aligned, intubation becomes difficult. In the researchers' study, the     investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This     neck collar renders intubation difficult not only by restricting neck movement, but also     reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and     Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.   "
68643|NCT02387476|"     This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to     characterize the clinical performance during a single night of therapy with a FRESCA mask     compared with a single night of therapy with their existing nasal Continuous Positive Airway     Pressure (CPAP) mask.   "
68644|NCT02387463|"     The most important method to slow down and stop the liver disease progression in patients     with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response     during treatment or obtain sustained viral response after treatment. The aim of the therapy     with interferon is make patients obtain immune control to HBV, in clinical practice, it was     expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive     patients. However, those targets can't be get in most patients by 48 weeks of interferon     treatment, and some patients need extended treatment to enhance the rate of HBeAg     seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of     interferon in HBeAg positive chronic hepatitis B patients will be evaluated.   "
68645|NCT02387450|"     Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of     the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in     term of morbi-mortality in patients with arterial claudication on a multicenter prospective     double blind study.   "
68646|NCT02387437|"     Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which     pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one     of the important therapy for improvement of this phenomenon. The previous research focuses on     the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom     investigators try to find the intuitive change of heterogeneity when recruitment maneuver is     implemented. In this study, the investigators compare three recruitment maneuvers on the lung     heterogeneity of ARDS.   "
68647|NCT02387424|"     Pregnant women with histories of depression are at high risk of depressive relapse/recurrence     during the perinatal period, and options for relapse/recurrence prevention are limited.     Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but     has not been studied among at risk pregnant women.      This study is the second phase of a multi-phase project adapting MBCT for perinatal women     (MBCT-PD).   "
68648|NCT02387411|"     Chronic heart failure (CHF) is a clinical syndrome presented with central, cardiac     deterioration as well as peripheral vascular and muscular abnormalities, resulting finally to     reduced exercise tolerance, quality of life and mortality rates. Exercise training is a major     component of rehabilitation / secondary prevention interventions, inducing significant     beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity     and quality of life, while a positive impact on hospitalization and mortality reduction     should not be also excluded. There has been growing interest in the characteristics and     modalities of exercise training able to induce optimal benefits. High intensity and interval     mode have been shown to induce greater benefits than moderate intensity and continuous mode     regimes. Additionally, there has been sound rationale for the inclusion of strength training,     which has been also shown able to yield benefits in terms of exercise capacity and quality of     life. However, there haven't been much data on the so called combined regimes, which include     both aerobic exercise and strength training. This study aims at investigating the effects of     combined high-intensity interval and strength training compared to high-intensity interval     exercise alone in CHF.   "
68658|NCT02387086|"     The purpose of this study is to determine whether thalidomide can improve the effectiveness     of the gefitinib in NSCLC patients with EGFR mutations.   "
68716|NCT02386332|"     This is an open-label, prospective, observational, multicenter, randomized study to compare     the efficacy between unrelated umbilical cord blood transplantation (UCBT) and     HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative     conditioning for adult patients with hematologic malignancies.   "
68649|NCT02387398|"     This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and     efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac     arrest patients without ST segment elevation. Safety will be assessed by evaluating the     association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute     renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed     by a composite endpoint of improved left ventricular regional and global function (both     regional wall motion analysis and left ventricular ejection fraction) as measured by     echocardiography prior to hospital discharge and favourable neurological function (Cerebral     Performance Categories 1 or 2) at discharge.   "
68662|NCT02387034|"     The purpose of this study is to determine whether an intervention with Physical activity on     prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would     result in effects on physical activity level, physical capacity and quality on life.      The hypothesis is that patients with osteoarthritis in hip or knee will increase their level     of physical activity significantly more with a PAP intervention compared to patients who only     get general advice about physical activity.   "
68663|NCT02387021|"     The purpose of the study is to determine whether the association of sciatic nerve block to     continuous adductor canal block is effective in the treatment of total knee arthroplasty post     operative pain .   "
68694|NCT02386618|"     Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of     colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread.     According to the investigators previous study, local residual neoplasia (LRN) after     conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic     therapy of LRN was not sufficient in 53 % and has not been standardized yet.   "
68763|NCT02385721|"     Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb     tablet.   "
68764|NCT02385708|"     Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line     to toes will decrease surgical site infections (SSI) by 30% when compared to patients who     receive routine standard of care (use of chlorhexidine cloths night before surgery and     morning of surgery).   "
68650|NCT02387190|"     Pulmonary dysfunction presented in patients with heart failure is observed as a decrease of     maximal aerobic capacity compared to healthy people. Lung function deterioration manifests,     in the presence of muscle fatigue and dyspnea on exertion, loss of functional capacity, and     activities limitation of daily living. Those manifestation influence the perception of     quality of life of patients1.      Patients with heart failure need to develop changes in lifestyle and daily activities aiming     to maintain clinical control and prevent the onset of complications and disabilities. If     these changes are not often performed, they might carry bigger burden to for the individual     and their family and for the healthcare system due to increasing of morbidity and mortality     between those patients2.      Systematic reviews conducted in developed countries (USA3, UK4 and Canada5) and developing     countries (Colombia6) have shown that telehealth can produce positive effects in individuals     with chronic diseases as heart failure. This kind of intervention seems to be effective in     preventing hospitalizations and non-elective emergency visits.      In Brazil, telenursing is still a non-standardized and non-diffused intervention. In this     perspective, telenursing represents soft new tools to provide quality care. It certainly     allows the orientation and training of patients, the permanence of them at home, reduces     unnecessary hospitalization. Additionally, this intervention, allows the management of     nursing time and strengthens their professional autonomy7.      The principal aim of this study is to describe the protocol to be used in MRE study. The     objective of MRE trial is to test the hypothesis that telenursing contributes to the     improvement in lung function over the medium term, in patients with heart failure under     continuous education.   "
68651|NCT02387177|"     The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use     with adolescents, and to test its feasibility, acceptability, and preliminary effect in     improving quality of life, and in decreasing stress and psychological distress.   "
68652|NCT02387164|"     The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD     (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process     leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell     autoimmunity as indicated by positive islet autoantibodies.   "
68653|NCT02387151|"     This study will test whether selected allogeneic bone marrow derived MSCs are safe by     assessing the composite end point Biopsy Proven Acute Rejection (BPAR)/ graft loss at 12     months.   "
68654|NCT02387138|"     This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities     (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule)     and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule).   "
68655|NCT02387125|"     This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305     [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1     recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or     non-small cell lung cancer that express NY-ESO-1.   "
68656|NCT02387112|"     The aim of the study is to assess whether, in patients who are listed for cardiac     transplantation in transplantable (T) status, early implantation of a left ventricular assist     device is superior to the current therapeutic strategy of medical heart failure therapy and     assist device implantation only after serious deterioration of the patient's condition.   "
68657|NCT02387099|"     The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to     exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor;      Routine use of everolimus shows an high rate of intolerability due to mucositis/stomatitis     especially during the first 12 weeks of treatment leading cause for treatment discontinuation     not related to tumor progression;      GeparQuinto study (setting III: non-responders): everolimus was given as salvage treatment in     combination with paclitaxel for patients without response to 4 cycles     epirubicin/cyclophosphamide with/without bevacizumab.      A dose-escalation schema was successfully used to improve tolerability of everolimus together     with the cytotoxic Agent.      Everolimus plus exemestane has improved the prognosis of metastatic breast cancer     significantly. Desiree-study aims to improve the tolerability, which is necessary in order to     achieve an adequate dose intensity for the patients in Routine care.   "
68659|NCT02387073|"     Recently the importance of electrical PRO system is increased for the accuracy, convenience,     and efficiency for both patients and physicians. For the evaluation of quality of life,     various self-reported questionnaires is filled-out by the patient, mostly in front of     outpatient clinic, and doctor usually take times to calculate the score. If there is     electrical PRO which is available with mobile device, the efficacy of clinic would be     improved. The investigators developed such a system and applied the system for patients with     spinal disease. The investigators assessed the effectiveness of application of electrical-PRO     in outpatients' clinic for patients who had filled-up same questionnaire in paper version.   "
68660|NCT02387060|"     Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly     effective, their use is not without problems. One is the increasing requirement of these     address the same nociceptive stimulus.      Opioid induced hyperalgesia could be an explanation studies in animal models. Through     mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and     changes in intracellular calcium regulation involved.      The hyperalgesia induced by intrathecal opioids is controversial. The investigators propose a     model study in patients undergoing cesarean section to study the secondary hyperalgesia     induced based on the study of nociceptive thresholds with two methods opioids: Von Frey     filaments and digital algometer.      If intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an     increase in sensitivity will occur. This increase can be measured by von Frey filaments,     expressed in increased requirement clinically opioids.   "
68661|NCT02387047|"     The aim of this study is to determine the validity of a self-questionnaire detecting seniors     phobia of falling living at home. A prospective monocentric observational study compares in a     blind way the presence of Diagnostic and Statistical Manual of Mental Disorders fourth     edition (DSM-IV) criteria for specific phobia, considered as the gold standard to the score     obtained at the detecting questionnaire for ≥70 years old seniors suspected of phobia of     falling and attending geriatric day hospital at the Bretonneau hospital (APHP, Paris).   "
68664|NCT02387008|"     Purpose: The goal of guided bone augmentation is to provide an alveolar ridge of sufficient     dimension to permit dental implant placement. While a wide variety of bone graft and barrier     membrane products are commercially available, limited evidence exists supporting the use of     one technique over another. The purpose of this study is to radiographically define the     dimensional bone changes following horizontal bone augmentation using a synthetic GUIDOR®     (Sunstar, Inc.) membrane. Secondary outcome measurements will include the assessment of     inflammation, infection, or other wound healing complications.      Participants: A total of 60 patients requiring bone augmentation of a single bound edentulous     site prior to dental implant placement will be selected for this study. This is a multicenter     study with 30 patients receiving treatment at each study site.      Procedures (methods): Patients will be randomly allocated to receive horizontal bone     augmentation with synthetic GUIDOR® membrane + freeze dried bone augmentation (FDBA),     synthetic GUIDOR® membrane alone, or xenograft BioGide® membrane + FDBA. CBCT imaging will be     obtained at baseline and 6 months post-operatively to assess dimensional alveolar ridge     changes. Additionally, post-operative appointments at 1, 2, and 4 weeks post-grafting will be     completed to assess the presence of inflammation, infection, wound dehiscence, or membrane     exposure.   "
68665|NCT02386995|"     The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring     such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological     conditions such as Parkinson's disease by comparing these monitoring with standard clinical     monitoring like heart rate, blood pressure and respiratory rate.   "
68666|NCT02386982|"     This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and     tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.   "
68667|NCT02386969|"     The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several     years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect     of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects.     The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes     a large homogeneous population suffering of central neuropathic pain.   "
68668|NCT02386956|"     Randomized clinical trial to evaluate the elongation of the hamstrings after making different     types of stretching. One group receives a stretch of global postural reeducation (RPG),     another group receives a mobilization of sciatic nerve, and a third group received a placebo     treatment. The evaluation of these treatments are done previously, immediately after and 20     min later. The test used to evaluate elongation are the Sit and Reach and active knee     extension (AKE test).   "
68669|NCT02386943|"     The objective of this study is to explore the effects of two DPP-4 inhibitors(Sitagliptin,     Saxagliptin) on β- and α-cell function, as well as the incretin effect.   "
68670|NCT02386930|"     The primary purpose of this study is to develop a behavioral lifestyle intervention and     evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes     in real life setting. This is because ambiguity still exists on the effectiveness of     behavioral lifestyle interventions in routine clinical practice despite of the efficacy of     large randomized controlled trials, suggesting the need for more research in this area.   "
68671|NCT02386917|"     Drug bioavailability and disposition vary according to body weight and weight loss after     bariatric surgery. This study evaluates the impact of body weight and weight loss on the     pharmacokinetics of various probe drugs, and compares these effects in three groups of     patients receiving either a gall bladder operation, gastric bypass or a very low calorie     diet.   "
68672|NCT02386904|"     The Purpose of the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for     bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the     safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy   "
68717|NCT02386319|"     ﻿The study's main objective is to investigate melatonin's analgesic, anxiolytic and     sleep-regulating effects in patients undergoing cosmetic breast surgery. Moreover, the     investigators intend to investigate the pharmacokinetic parameters of melatonin in this     patient population.   "
69957|NCT02370134|"     This study is aimed to study the feasibility and safety of parkinson's glove that combined 2     module of tremor detection and tremor suppression with electrical muscle stimulation for     using as device for rest tremor suppression in parkinson's disease patients   "
68673|NCT02386891|"     Based on preliminary data and previous studies, the investigators hypothesize that the     ambient temperature experienced by an individual influences his or her food intake in males     and females aged 19 to 30. Specifically, exposure to temperatures above the thermoneutral     zone (TNZ) will decrease consumption in young adults in a sedentary situation. Researchers     will execute a randomized control trial specifically testing thermal exposure and its effect     on an individual's food consumption. Participants will receive and wear a t-shirt. They will     have a thermal image taken of the inner canthus of their eye and middle finger nail bed,     representing a baseline of core and peripheral temperatures, respectively. They will be     randomized to either a colder environment (65°F) or a warmer environment (75°F) under the     artifice of monitoring routine office work with abnormal temperature conditions. Their     knowledge of the experiment will be limited until the end. They will experience this     temperature while filling out paperwork and performing basic office tasks. After one hour,     another thermal image will be taken. Each participant will be presented with a large, Mellow     Mushroom cheese pizza and directed to eat at their leisure and subsequently finish the office     tasks over the next hour. The participants will then be debriefed on the parameters of the     experiment and body measurements will be taken at the end so as to prevent bias of the     subject by limiting their food intake. The investigators will quantify energy intake by     weighing remaining food and comparing to known caloric content by weight from bomb     calorimetry tests. The infrared thermal images will determine whether the temperatures     experienced were extreme enough to initiate a change in thermoregulation.   "
68674|NCT02386878|"     The PHE study is a two-year longitudinal study evaluating two interventions for reducing     depression and HIV risk behaviors among highly vulnerable adolescents in the Eastern Cape of     South Africa. Research suggests that children affected by AIDS are at heightened risk of HIV     infection relative to their peers; however, evidence on how best to address HIV prevention     and psychological health among this population is lacking. This study examines the efficacy     of both a psychological and behavioral intervention, alone and in combination, on related     outcomes among vulnerable youth age 14-17. A mixed methods approach is applied, including a     community-randomized controlled trial with a factorial design, a cost-effectiveness analysis,     and a qualitative component. At baseline data collection in January 2012, more than 1000     adolescents and their caregivers were interviewed; these participants were invited to take     part in two more survey rounds designed to examine both the immediate and long term effects     of the interventions. Support for this research was provided by USAID under Grant No.     GHH-I-00-007-00069-00.   "
68675|NCT02386865|"     Although several prognostic models have been developed to predict outcome for patients with     severe traumatic brain injury (TBI), currently no study describes the impact of respiratory     failure during Emergency Department treatment on mortality in a population of elderly     patients. The purpose of the present study was to evaluate factors predicting poor outcome     with special emphasis on the impact of respiratory failure on mortality in elderly patients     with isolated severe TBI.      All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this     Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were     identified from the trauma registry. Stepwise logistic regression analysis was used to     identify risk factors for a poor prognosis and outcome.      The logistic regression found the following variables influencing the mortality: respiratory     failure (p<0.0005; OR: 9.369), pupillary response (p<0.0212, OR: 3.393) and ISS score     (p<0.0001, OR:1.179). A significant (p<0.0001) increased risk of death was also found for     patients with a midline shift >15 mm.      The present study predicts a strong correlation between respiratory failure, pathological     pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly     patients sustaining an isolated severe TBI.   "
68676|NCT02386852|"     There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive     performance, however, very little is known about the mechanisms associated with such     improvement. Here, we tested whether cardiovascular reactivity to a task is associated with     cognitive improvement.   "
68677|NCT02386839|"     This observational study will compare safety and efficacy treatment outcomes in infants that     received study drug treatment with infants that received standard neonatal care in Study     ROPP-2008-01 (NCT01096784).   "
68678|NCT02386826|"     The purpose of this study is to determine whether the combination of two agents, INC280 and     bevacizumab, is safe and effective when administered to patients with Glioblastoma Multiforme     (GBM) who have progressed after receiving prior therapy or who have unresectable GBM.   "
68679|NCT02386813|"     This study is to explore risk factors for poor progression-free survival (PFS) and overall     survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with     non-anthracycline based treatment.   "
68680|NCT02386800|"     This roll-over protocol allows patients who are still receiving clinical benefit to continue     to be treated from multiple protocols in one program spanning multiple indications during the     completion of the parent study/(ies). The population for the roll-over study should be     consistent with the population defined in the program parent study/(ies). The primary     eligibility criteria for a patient to enter the roll-over protocol is the participation and     completion of a Novartis OGD&GMA/Incyte study with ruxolitinib. Efficacy parameters would not     be measured; however safety data will be collected.      Patients who have completed a prior study with ruxolitinib and who are assessed by the     Investigator to continue to benefit from ongoing treatment with the investigational     ruxolitinib will be eligible.   "
68681|NCT02386787|"     Aspiration of gastric content is a rare but serious complication of anesthesia. In this     context, preoperative fasting for elective surgery is well defined. In an emergency     situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk     of aspiration. In semi emergency situation, there is no consensus about the anesthetic     procedure even if a preoperative fasting has been observed due to uncertainty of gastric     emptying related to stress or painful condition. The choice of anesthesia induction technique     depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool that can     provide reliable quantitative information about the volume of gastric content.   "
68976|NCT02382939|"     This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of     once weekly dosing of somapacitan (administered with an investigational pen) with daily     Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in     previously human growth hormone (hGH) treated adults with growth hormone deficiency.   "
68682|NCT02386774|"     In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed     with two reflectance microscopes attached on a mounting with limited movement along the XYZ     axes. Consequently, ocular diseases in the central area have been described (mostly cornea     and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a     multifluorescent one) present significant innovations that the investigators want to assess     in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract     diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective.     It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids,     proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use     of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by     revealing staining patterns corresponding to a specific disease and not to others (part 2 of     the study)   "
68683|NCT02386761|"     A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending     doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of     inhaled chf 6001.   "
68684|NCT02386748|"     The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the     recovery of intestinal movement after cesarean section.      All women undergoing elective cesarean section in King Faisal military hospital will be     candidate for this trial after full explanation of the trial and informed consent to be taken     from the women. Exclusion criteria will include emergency cesarean section, multifetal     pregnancy, polyhydramnios, medical disorders with pregnancy, abnormal placentation (previa     and/or accreta), past history of bowel injury or operation, any complications that will     increase operative duration such as uterine artery injury or uterine extension.      450 consented women for being enrolled in this clinical trial and candidates for elective     cesarean section will be divided into 3 groups:        -  Group A, 150 women will receive sugarless gum after their operating room discharge by 2          hours for at least half an hour at two hours interval.        -  Group B, 150 women will receive the traditional management of starting oral fluids after          operating room discharge by 6 hours and hearing intestinal sounds on second day before          initiating full regular diet.        -  Group C, 150 women as control group, they will not receive neither gum nor oral fluids.          They will be in intravenous fluid.      All demographic data of these women, indication of operation, operation time, type of     anesthesia and pathway during hospital stay will be recovered and compared between 3 groups.   "
68685|NCT02386735|"     Background      Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative     treatment. In Switzerland estimated 5-7% of the total population are suffering from this     chronic disease. According to current guidelines corticosteroids are part of treatment of     acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate     the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of     hospitalization, reduce treatment failure rate and improve clinical outcome. The additional     therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The     investigators recently published a hospital-based study showing that in patients presenting     to emergency departments with acute exacerbation of COPD, a short five day treatment with     systemic steroids was not inferior to a conventional 14 day treatment with regard to     re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the     investigators knowledge no data is available about the minimal necessary corticosteroid dose     in an outpatient treatment setting so far.      Aim      The primary aim of this study is to investigate in an outpatient setting, whether a three day     treatment with orally administered systemic corticosteroids is non-inferior to a five day     treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced     by shorter therapy.      Hypothesis      The investigators postulate, that in an outpatient setting, where generally less severe     exacerbations are being treated, a three day treatment duration of systemic corticosteroids     should be non-inferior to a five day treatment duration with regard to treatment benefits but     decrease cumulative corticosteroid exposure.      Design and Setting      This study is going to be performed as a prospective, randomized, double-blind,     placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be     performed as block randomization with a 1:1 allocation. The investigators are going to     recruit GPs in northwestern and central Switzerland.      Methods      The investigators are going to include patients presenting to GP's with acute exacerbation of     COPD. When matching the investigators eligibility criteria and written informed consent is     given, patients included in the study are receiving systemic corticosteroid treatment     (equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days     (interventional arm) followed by two days of placebo for the interventional group.     Pre-randomized, identically looking, numbered blisters are given to all patients included in     the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is     given to all patients with a CRP ≥50mg/l, COPD and known diagnosis of bronchiectasis, as well     as patients presenting with all three of the following symptoms: change of baseline dyspnea,     change of sputum quantity and sputum purulence. Further initial treatment and steroid     treatment after inclusion is determined and documented by the GP. Patients will undergo     follow-up visits at day three and seven by their GP as well as follow-up phone calls executed     by the study center at day 30, 90 and 180.   "
68706|NCT02386462|"     Dexmedetomidine can be used as a co-induction agent to facilitate laryngeal mask airway (LMA)     insertion with minimal effect on respiratory function. The purpose of the study was to     determine the median effective dose (ED50) of dexmedetomidine to facilitate LMA insertion     during anaesthesia induction with propofol 2.0 mg/kg.   "
68686|NCT02386722|"     Asthma and chronic obstructive pulmonary disease (COPD) are common lung. Despite the     important progresses achieved in treatments, the majority of affected patients suffer from     severe symptoms and tend to be frequently hospitalised due to exacerbation. Reasons for     uncontrolled asthma and COPD are manifold, but often a poor inhalation technique and a poor     following of the prescribed treatment plan is observed, which is called non-adherence.      The primary aim of this study will therefore be to measure medication adherence in patients     with chronic obstructive lung diseases, and to investigate the impact of an audio reminder on     disease outcomes and quality of life.      The investigators hypotheses will be that an adherence reminder, improve medication adherence     and that a good medication adherence elongate the time to next exacerbation in patients with     chronic obstructive lung diseases.      A prospective single-blind randomized controlled study is planned, where the investigators     are going to analyse the adherence over a period of six months of in- and outpatients, who     have experienced at least one exacerbation during the last year. The adherence of     intervention- and control group will be measured by specific electronic data capture devices     which can save each actuation with date and time. Patients assigned to the intervention group     will be reminded for the inhalation by an audio reminder and will receive support calls if     medication will not be taken as prescribed or if rescue medication will be used too often. In     contrast, the control group, will not be reminded and will not receive any calls, if do not     comply with the prescribed medication schedule or if they use their rescue medication too     frequently.      During study period, participants will be assessed every two months. Each assessment will     include spirometry, measurement of diffusion capacity, exhaled nitric oxide and carbon     monoxide. Moreover participants will demonstrate their inhalation techniques by using placebo     devices and fill out questionnaires regarding quality of life.      Statistical significance will be acquired if a p value of less than 0.05 is attained. Time to     next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard     model. Results will be reported as HR (hazard ratio) with corresponding 95% confidence     interval (CI) and p-value.      Time to next exacerbation is subject to the investigators power calculation. A previous     study has shown that 30% of COPD patients are readmitted again within six month because of an     exacerbation. The investigators expect that 12% of patients in the intervention group will     have an exacerbation. This corresponds to a hazard ratio of 0.36. Assuming a sample size of     70 subjects for each study group, there is a power of 80% to detect a HR of 0.36 based on a     one-tailed test. Additional 14 subjects (7 for each study group) have been added to account     for drop outs. Therefore, 154 subjects will be investigated in this study.   "
68687|NCT02386709|"     Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The     aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete     Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate     of pCR is about 20%, although there are important variations according to tumor subtype and     the type of treatment. The objective of the new therapeutic strategies is to increase this     response rate.      The purpose of this study is to investigate the possibility of early evaluation of     neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron     emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.   "
68688|NCT02386696|"     Recently, ultrasound artifacts mimicking lung sliding have been described in absence of the     visceral pleura, in a group of patients who underwent pneumonectomy. In these patients, lung     sliding was clearly absent during mechanical ventilation in the operated hemithorax. During     spontaneous breathing, although of lower intensity compared to the unoperated hemithorax,     some artifacts mimicking lung sliding and seashore sign were found during each deep     spontaneous breath. These findings have led to the hypothesis that these artifacts may be due     to the contraction of the intercostal muscles.      The objective of the present study is to reproduce such artifacts during contraction of the     inspiratory and expiratory muscles with closed glottis (Valsalva and Muller maneuvers): in     this condition each subject is not ventilating and the two pleural layers are not sliding one     over each other.   "
68689|NCT02386683|"     The purpose of this study is to explore the effectiveness of lung-protective ventilation     during general anesthesia for neurosurgical procedures on postoperative pulmonary outcome,     compared with traditional ventilation.   "
68690|NCT02386670|"     This 5-year randomized controlled trial will compare the efficacy of non-invasive brain     stimulation (trans-cranial Direct Current Stimulation - tDCS) combined with cognitive     remediation (CR) versus sham (placebo) tDCS combined with sham (placebo) CR in slowing     down cognitive decline and preventing Alzheimer's Dementia in older persons with mild     cognitive impairment or major depressive disorder with or without mild cognitive impairment.   "
68691|NCT02386657|"     Sickle Cell Disease is a serious disease that is life-threatening for patients being     homozygous for the SS form or heterozygous for the SC or bthal forms. The CHU Brugmann     hospital currently regularly treats about 70 homozygous adult patients and this number is in     constant augmentation. The age average of the patients is below 30. The hospital developed a     close collaboration with the Queen Fabiola Kids University Hospital to optimize the     transition of young sickle cell patients from the pediatric to the adult network.      The emergency care of sickle cell patients remains a source of worry. Even with a correct     treatment (Hydroxy-urea or exsanguineous transfusions), patients suffer from frequent sickle     cell disease crisis when stress or infection cause hemolysis. The pain level is intolerable     and causes emergency hospital admission (2 to 3 crisis per patient per year on average). The     crisis are more frequent with poor compliance to the treatments.      There are several obstacles to the rapid and optimal management of these patients:        -  fear of causing addiction to heavy pain releaf products (high dosis of morphine)        -  lack of biological parameters for the determination of the crisis severity.      The prognostic value of the lactate dehydrogenase (LDH) level in a vaso-occlusive crisis was     recently stressed while activation of the coagulation, translated by the elevation of various     parameters including the rate of DD dimers, seemed associated with clinical complications.     The deleterious role of increased oxidative stress has also been recently demonstrated in     patients with sickle cell disease, opening new therapeutic avenues.      This study aims to prospectively evaluate the management of sickle cell patients being     admitted in the emergency department for a vaso-occlusive crisis. The level of satisfaction     of the patients will be measured.      The investigators will also evaluate the predictive value of several routine biological     parameters regarding the severity of the crisis, including the values of nitrous albumin     (PNA) as marker of oxydative stress. This last dosage will be made in collaboration with the     team of Dr Wayenberg and Pr Bottari in Grenoble.   "
68692|NCT02386644|"     This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment     compared with speculum examination, nitrazine and placental micro globulin-1 tests.   "
68693|NCT02386631|"     Hallux valgus can be defined as a progressive subluxation of the first metatarsophalangeal     joint and lateral deviation of the hallux. This common foot condition is associated with     altered gait patterns. Specifically reduced forward propulsion, leading to gait instability.     Research has shown that foot problems and pain play a major role towards the contribution of     falls in the adult population. There are currently two main interventions for the treatment     of hallux valgus: surgery and orthotic prescription. There has not been a lot of research     performed evaluating the effects of custom orthotic prescription on hallux valgus.      Therefore, this study will investigate adults with moderate hallux valgus and the effects of     orthotic intervention on the efficacy of forward propulsion during walking. It is     hypothesized that implementation of an orthotic will lead to decreased foot pain, an increase     in step length, an increase in the forward moment about the ankle and hallux, and a more     medial center of pressure tracking through the great toe instead of the lesser metatarsals.      This study will consist of 10 adults. The participant will go through three rounds of testing     in the lab. The first session will consist of initial baseline testing in which each     participant will be evaluated for severity of Hallux Valgus and range of motion of the first     metatarsophalangeal joint. A foot casting will then be performed by a pedorthist and the     participant will be set up with markers, so as to record motion while they perform 15 walking     trials across a 10m runway with a force plate embedded in the middle whilst wearing standard     footwear (no orthotic). The second lab session will consist of the standard footwear (no     orthotic) walking as well as the addition of standard footwear with custom orthotic walking.     The third session, after having worn the orthotic for two weeks, will repeat both conditions     measured in the second lab session. Data about the center of pressure trajectories, step     length, foot pain, and the moments about the ankle and first metatarsophalangeal joints will     be collected and calculated.   "
68719|NCT02386293|"     The purpose of this study is to test the hypothesis that hypertension increases the     anti-natriuretic effects of an angiotensin receptor antagonist during mental stress in     overweight/obese African-American's who retain sodium during mental stress.   "
68696|NCT02386592|"     The purpose of this study is to estimate the burden of disease, identify risk factors     associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost     measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the     investigators propose to study the impact of a novel package of infection control     interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center     in sub-Saharan Africa.   "
68697|NCT02386579|"     The study is designed to investigate biomarkers related to bone turnover in diabetics with     charcot foot. This is done by measuring local blood samples in the feet, and systemically in     a vene and an artery. Measurements are done before and after cooling the feet in icewater to     lower the bloodflow.      Patients will be compared with healthy diabetic controls.   "
68698|NCT02386566|"     The primary objective of the study is to determine the association between prospectively     measured disability (Expanded Disability Status Scale [EDSS]) with quality of life (Multiple     Sclerosis International Quality of Life Questionnaire [MusiQoL]) at 3-month intervals up to 1     year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The     secondary objectives of this study are as follows: To evaluate the cumulative probability of     sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the     association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function     [FSMC]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19     [MSISQ-19]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]) and neurocognitive     function (Symbol Digit Modalities Test [SDMT]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to     6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the     relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse)     and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of     clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year     after initiation of natalizumab treatment; To describe changes in work impairment (Work     Productivity and Activity Impairment in MS [WPAI-MS]) at 3-months intervals up to 1 year     after initiation of natalizumab treatment; To describe any change in the percentage of     disability pension and occupation after 1 year of natalizumab treatment; To record the     incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse     Reactions (SUSAR) throughout the study   "
68699|NCT02386553|"     The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen     administered intrathecally in preventing or delaying the need for respiratory intervention or     death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA).     Secondary objectives of this study are to examine the effects of Nusinersen in infants with     genetically diagnosed and presymptomatic SMA.   "
68700|NCT02386540|"     The purpose of this study is to determine whether health coaching initiated in the emergency     department (ED) reduces subsequent ED visits, increases primary care visits, and positively     impacts health outcomes in patients with diabetes and/or hypertension.   "
68715|NCT02386345|"     This is a registry to assess the safety and effectiveness of FIRM guided procedures for the     treatment of symptomatic any type of atrial fibrillation.      FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors     identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView®     mapping system. In addition to the FIRM guided ablation any other ablation method could be     applied.The acute success of FIRM ablations is defined as elimination of rotors defined by     absence of rotors.      Data items will be collected, if available, consistent and applicable with routine and     standard clinical care at each participating site.   "
68701|NCT02386527|"     Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is     estimated that as many as 3 million adults may suffer from the disease. Fortunately in the     last few years, a shift in strategy toward the earlier institution of disease modifying drugs     and the availability of new classes of medications have greatly improved the outcomes that     can be expected by most patients.      The goal of treatment now aims toward achieving the lowest possible level of arthritis     disease activity and even remission, if possible as early on as possible. Research has shown     that this translates into minimized joint damage and enhanced physical function and quality     of life for the RA patient. This also requires that a diagnosis of RA be made as early on as     possible, and herein lies the challenge, i.e. identifying the RA patient early on in the     course of their disease.   "
68702|NCT02386514|"     To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the     traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.   "
68703|NCT02386501|"     This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the     maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164.     Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.   "
68704|NCT02386488|"     The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine     after single and multiple oral dosing to healthy Chinese men and women.   "
68705|NCT02386475|"     Cortical plasticity plays a pivotal role in functional recovery after a stroke.     Neurotransmitter release, facilitates the creation of new synapses and promotes brain     plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the     release of neurotransmitters in patients with first stroke.   "
68720|NCT02386280|"     To investigate whether brief motivational intervention is associated with the change of     parenting style in parents of teenagers seeking to prevent drug use among their children.   "
68707|NCT02386449|"     This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon     cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria     will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II     (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before     colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take     Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.   "
68708|NCT02386436|"     GSK2330811 is a humanised monoclonal antibody, that blocks Oncostatin M (OSM), which is being     developed for the treatment of inflammatory and fibrotic diseases. This first time in human     study will evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and     immunogenicity profile of single ascending subcutaneous (s.c.) doses of GSK2330811, in     healthy subjects.      This study will be a randomised, double-blind (sponsor open), placebo-controlled, single     centre, single dose escalation study of s.c. administrations of GSK2330811 in healthy     subjects. Approximately 40 subjects will be enrolled in the study, across 5 cohorts. Each     cohort is planned to consist of 8 subjects, randomised such that 6 subjects will receive     GSK2330811 and 2 subjects will receive placebo.      The starting dose for the study will be 0.1 milligram (mg)/kilogram (kg) s.c. single dose and     the highest dose will be 6 mg/kg s.c. single dose. Subjects will be admitted to the clinical     unit on the day prior to dosing (Day -1). On Day 1, each subject will receive a s.c. dose of     GSK2330811 or placebo. Subjects will then remain as an in-patient until discharged on Day 8,     after assessments have been performed. The duration of the study, including screening, is     approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5.   "
68709|NCT02386423|"     The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap     that produces adjustable targeted pressure on specific muscles in the feet, to reduce the     symptoms of moderate to severe primary Restless Legs Syndrome.   "
68710|NCT02386410|"     Anxiety is the most frequent psychiatric problem in children. Untreated anxiety often has a     chronic course, or may be a recurring condition. Anxiety in children predicts a variety of     psychiatric disorders later in life, and involves problems regarding school performance and     social relations. The literature provides a number of factors, which are suggested to     increase the risk of developing an anxiety disorder. In particular, it has been shown that     children of parents with anxiety disorders are at much greater risk of developing an anxiety     disorder. Several studies have found a correlation between anxiety in the child, and parent     behavior characterized by criticism, control and overprotectiveness. The present study aim to     preliminary evaluate whether a eight week parent training intervention can reduce the     incidence of anxiety disorders in children and to evaluate the feasibility of the parent     training. Three central factors has been the basis in developing the parent training, all of     which are considered to be involved in the development and maintenance of anxiety disorders     in children (1) criticism and rejection, (2) control and overprotectiveness, and (3) parental     modeling and reinforcement of anxiety. The goal of the parent training is therefore (1) to     increase warmth and acceptance, (2) to increase autonomy for the child, and (3) modeling and     reinforcement of brave behavior. The investigators intend to include 60 anxious parents in     the study, who will be randomly allocated to either group parent training, Internet delivered     parent training, or wait-list condition. The inclusion criteria are as follows: The parent     states that he/she experiences anxiety or worry, the parents' child is 6-12 years old, and do     not fulfill criteria for an anxiety disorder or major depressive disorder, the parent     possesses everyday access to the Internet, and there is no presence of very aggravated family     situations, such as parent substance abuse or severe depression, or domestic violence.   "
68711|NCT02386397|"     This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib     administered in combination with mGEMOX in patients with advanced biliary tract cancer.   "
68712|NCT02386384|"     Question: Can implantation failure (IF) be predicted prior to in vitro fertilization (IVF)? A     pilot, non-interventional, clinical study Prospective, controlled, cohort study   "
68713|NCT02386371|"     The investigators propose a prospective, multicenter, single arm Phase II design to evaluate     the feasibility of repeated breast-conserving surgery combined with re- irradiation using     IORT after local recurrence of breast carcinoma.   "
68714|NCT02386358|"     The purpose of this study is:        1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution of          chronic Chagas disease in adult patients by means of a randomized, double-blind clinical          trial (RCT).           Also:        2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of          Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared          with conventional serology (CS)        3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite          load as an early therapeutic effect.        4. to determine the potential of such serological and parasitological methods as predictors          of therapeutic effect or failure.   "
68718|NCT02386306|"     This is a Phase 1b, multi-center, randomized, double-blind, placebo-controlled study designed     to evaluate the safety, tolerability, and pharmacokinetics of GC021109 in subjects with mild     to moderate Alzheimer's Disease (as determined by 2011 National Institute on Aging-     Alzheimer's Association [NIA-AA] criteria and Mini Mental State Examination [MMSE]). The     Investigator, study site staff, (with exception of a designated pharmacist/pharmacy     technician) and all study subjects will be blinded to randomized study medication assignment     until database lock. Treatment assignments may be unblinded for select pre-authorized     individuals involved in the safety and PK data reviews in order to accurately determine how     to proceed with dose escalation.   "
68721|NCT02386267|"     Diamond-Blackfan anemia (DBA) is a rare congenital syndrome associated with physical     anomalies, short stature, red cell aplasia, and an increased risk of malignancy.      Mutations affecting genes encoding ribosomal proteins cause DBA. Genetic studies have     identified heterozygous mutations in at least one of eight ribosomal protein genes in up to     50% of cases.      25% of patients carry a mutation in the ribosomal protein (RP)S19 gene, whereas mutations in     RPS24, RPS17, RPL35A, RPL11, and RPL5 are rare.      p53 activation has been identified as a key component in the pathophysiology of DBA after     cellular and molecular studies. Other potential mechanisms that warrant further investigation     include impaired translation as the result of ribosomal insufficiency, which may be     ameliorated by Leucine supplementation.      Despite significant improvements in understanding of the pathophysiology of Diamond Blackfan     anemia (DBA), there have been few advances in therapy. The cornerstones of treatment remain     corticosteroids,chronic red blood cell transfusions, and hematopoietic stem cell     transplantation, each of which is fraught with complications. Other treatments have been     shown to be effective in only a few patients or in individual case reports : IL-3,     cyclosporine (alone or in combination with steroids), metaclopramide. Gene therapy is still a     part of research programs.      There are some indications that the Amino Acid (AA) L-leucine, a translation enhancer, may     have some efficacy in DBA and 5q-syndrome, which has the same altered ribosome functions as     the DBA. L-leucine is an essential AA that is unique among the branched-chain AA acting as a     nutrient regulator of protein synthesis in skeletal muscle and adipose tissue.      Several preclinical studies with DBA lymphocytes exposed to various L-leucine doses, have     demonstrated that protein synthesis can be increased by using high doses L-leucine.      Recent clinical data on L-leucine therapeutic use have demonstrated increase the hemoglobin     level and transfusion independence in patients with DBA and 5q-syndrom.      These data support the rationale for clinical trial on L-leucine use as a therapeutic agent     for DBA patients.   "
68722|NCT02386254|"     To evaluate whether a premorbid functioning scoring system such as the ECOG system can be     adapted to predict ICU morbidity and mortality.   "
68723|NCT02386241|"     This study will compare genomic alterations between the parents and the patients with     high-grade glioma.   "
68724|NCT02386228|"     A collection of biological samples (cerebrospinal fluid [CSF] and blood) from patients under     6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.   "
68725|NCT02386215|"     This randomized controlled trial will explore whether the provision of oral HIV self-test     kits to women can increase HIV testing among their male partners. The study will recruit     adult women from antenatal care and post-partum clinics in Kisumu. Each participant will be     randomized to either receive two HIV self-tests or to receive counseling referring their     partner to HIV testing (standard of care). Over a 3 month period, we will obtain information     from study participants on how many sexual partners they offered the tests to, the     receptivity of their sexual partners to using self-tests, and the incidence of any adverse     events. We will compare partner testing rates in intervention and control groups.   "
68726|NCT02386202|"     To determine the incidence and predictors of augmented renal clearance (ARC) in patients with     hemorrhagic stroke.   "
68727|NCT02386189|"     The purpose of this study is 1) to learn how VA patients can help share their health     information between their VA providers and providers outside the VA and 2) if sharing this     information is useful to providers and improves care received.   "
68728|NCT02386176|"     The investigators are interested in assessing the value of and comparing the use of automated     breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary     procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform     a preliminary prospective study on women who are most likely to benefit from the use of ABUS     and/or DBT (or a combination of both) in the screening environment.   "
68729|NCT02386163|"     According to many researches, mesenchymal stem cells (MSC) isolated from synovial membrane     and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and     ability to undergo chondrogenesis.      Based on this concept, the investigators plan to get two removed tissues (synovial membrane     and infrapatellar fat pad) from patients who have an operation of TKR (Total Knee     Replacement). The investigators are going to isolate and expand MSC from these two tissues     respectively, and then compare their characterization and potential for clinical application.     In the other hand, the investigators plan to build techniques and procedures which comply     with Good Tissue Practices (GTP).   "
68730|NCT02386150|"     This study seeks to determine the safety and immunogenicity of a series of 3 primary     vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA     1-33/44-198) vaccine (RVEc) at 10 or 20 μg intradermally (ID). This study is evaluating if     RVEc will display an acceptable safety profile as determined by adverse event (AE) data and     if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in     vaccine recipients.   "
68731|NCT02386137|"     Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is     increasingly being used worldwide to treat symptomatic uterine fibroids because of its     excellent therapeutic efficacy in controlling symptoms and its excellent safety record.     Despite the benefits, it should be recognized that MR HIFU ablation does not always yield     good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume     transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most     well-known risk factors for poor ablation outcomes as measured with the non-perfused volume     (NPV) ratio (ie, NPV divided by fibroid volume).      The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and     contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion     imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine     fibroid treatment by MR-HIFU.   "
68747|NCT02385929|"     The purpose of this study is to explore whether early initiated physical exercise concurrent     with a swallowing and mouth opening exercise program will have a positive effect on     swallowing function and other quality of life aspects in patients treated with radiotherapy     for head and neck cancer. The investigators hypothesize that patients who complete the     program will have improved swallowing function and physical function one year after     completing their treatment compared to patients who do not participate in the training     program.   "
68732|NCT02386124|"     In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50     years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%,     respectively, due to more effective therapies and lower mortality of many diseases. Yet,     chronic diseases are nowadays more important, and often coexist as comorbidity or     multimorbidity, depending on whether an index condition has been considered. These conditions     increase the risk of death and reduce functional autonomy in the elderly and, therefore,     should be carefully considered within comprehensive geriatric assessment. The epidemiology of     cardiovascular disease, as demonstrated among others by the Oxford Vascular Study, shows a     clear trend in age-dependent, as the number of events and their incidence increases with age,     and about half are concentrates over 75 years.      In addition, some observational studies in elderly patients have suggested an association     between frailty and cardiovascular disease: fragility and cardiovascular disease share a     common biological pathway, and cardiovascular diseases may accelerate the onset of frailty.     The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease,     according to the rating scale used and the population studied. Frail patients with     cardiovascular disease, in particular those undergoing invasive procedures or suffering from     coronary artery disease and aortic valve disease, have a much higher adverse events and     complications, suggesting the need for a more accurate functional stratification and a more     careful evaluation of the risk/benefit ratio of some invasive procedures.      Among the numerous tests proposed in the literature for the functional evaluation and     objective measures of physical capability in elderly patient, the Short Physical Performance     Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those     characterized by an improved prognostic ability and an easy administration.      The present study is performed to assess if SPPB and handgrip are helpful to better stratify     the prognosis (all-causes death and hospital admission for all causes) in elderly patients     admitted to hospital for cardiac causes.   "
68735|NCT02386085|"     Currently, there is a significant deficiency in evidence regarding the safety of osteopathic     manipulative treatments (OMT). To address this deficit, this study is designed to     systematically evaluate the incidence and severity of OMT adverse events and examine the     relationship of these adverse events to the technique(s) used and the body region(s) treated.     The study is being conducted at the clinics of participating members of DO-Touch.NET, the     only known practice-based research network (PBRN) focused on osteopathic manual medicine     research. Eligible patients who receive OMT at one of the participating clinics will be asked     to complete either a paper or online survey regarding any adverse events they experience     within 1, 3, and 7 days following their treatment. Information regarding their diagnoses,     which osteopathic techniques were used in their OMT, and which body regions were treated will     be obtained from participant medical records. This data will be used to answer the following     research questions:        1. What is the incidence of adverse events from osteopathic manipulative treatment?        2. What types of adverse events occur following osteopathic manipulative treatment?        3. Are there individual osteopathic techniques in particular body regions that have higher          incidences of adverse events than other techniques or body regions?        4. Is the incidence of adverse events higher for some patient conditions than others?   "
68736|NCT02386072|"     A study to identify factors that are associated with improved effectiveness in pharmacologic     therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF     (Overactive Bladder Questionnaire Short Form)   "
68737|NCT02386059|"     Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and     vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may     be the long duration of surgery and anesthesia and the high degree of manipulation of the     eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of     several complications, such as suprachoroidal hemorrhage, with disastrous visual     consequences.      To date there is no evidence as to the possible protective effect of anti-emetic therapy with     regard to interventions of vitrectomy performed under local anesthesia.      In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy     of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and     vomiting in patients undergoing vitrectomy under local anesthesia.   "
68738|NCT02386046|"     This study aims to determine normative values of oxygen saturation in late preterm infants,     and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and     those not requiring it.   "
68739|NCT02386033|"     ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A     reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The     aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an     adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation     defects.      Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus     placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative     vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level     (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded     at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill     was done at 6 and 9 months, using a computer-aided software.   "
68740|NCT02386020|"     The present study is designed to investigate the effectiveness of AV gel local drug delivery     as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic     periodontitis (CP) and type 2 diabetes mellitus (DM).   "
68741|NCT02386007|"     The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and     safety of each dosage group in Korean patients with acute and chronic gastric inflammation.   "
68742|NCT02385994|"     The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten     dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of     melasma and lentigines on the face in Asian skin.   "
68743|NCT02385981|"     H-1: tcpO2U2 > tcpO2U1 H-0: tcpO2U2 ≤ tcpO2U1   "
68744|NCT02385968|"     The aim is to investigate if herniated nucleus material in lumbar disc herniations is     infected with bacteria, and if so, to determine their prevalence (control group), and to     determine if patients with pre-existing Modic changes type 1 have a higher incidence of     bacterial growth in relevant lumbar disc samples than patients without Modic changes.      A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery     will be examined.   "
68745|NCT02385955|"     This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical     cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two     myeloablative conditioning regimens will be used in this study: (1) total body irradation     (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.   "
68746|NCT02385942|"     The purpose of this study is to analyse utility and compatibility of U-health solution     service based on mobile for chronic wound management.   "
68748|NCT02385916|"     According to the Canadian Cancer Society, 1 in 9 Canadian women will develop breast cancer in     her lifetime and 1 in 30 will die. The single greatest risk factor of breast cancer is poor     estrogen metabolism. EstroSense®/MD is a natural health product that promotes and supports     healthy estrogen metabolism. It may increase the ratio of good estrogen to bad estrogen     and potentially reducing the risk of breast cancer. For this proposed study, the     investigators will be examining the effect of EstroSense®/MD compared to placebo, on estrogen     metabolism in 120 women.   "
68765|NCT02385695|"     The purpose of this study is to compare outcomes of (i) surgical treatment with posterior     dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in     patients with multilevel lumbar degenerative disk disease.   "
68749|NCT02385903|"     Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in     diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization     procedure cannot be provide in all cases. Flammacerium, by a crust training and its     anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination     and then improve some incapacitating symptoms like odor or pain. This product may allow to     delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the     investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of     the lower limb in patients where no revascularization can be provide. The investigators     observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution,     wound size decrease.   "
68750|NCT02385890|"     The objectives are to test the acute effects of different bagels containing pulse ingredients     on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake     two hours following consumption of pulse products.      The investigators hypothesize that bagels containing pulse ingredients will lead to lower     blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.   "
68751|NCT02385877|"     The purpose of this study is to perform first-in-human PET imaging studies of two new cardiac     sympathetic nerve imaging agents, 4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG)     and 3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG).   "
68752|NCT02385864|"     Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite     the current use of three or more antihypertensive drugs at full doses, including a diuretic.     Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly     prevalent in patients with resistant hypertension.      The prospective observational POP-ART study will assess the efficacy of continuous positive     airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect     data from usual care.   "
68753|NCT02385851|"     This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects     to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC)     injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.   "
68754|NCT02385838|"     The purpose of this interventional study is to compare the impact of four different     Front-Of-Pack (FOP) nutrition labels on purchasing intentions. This study is nested in the     ongoing web-based prospective observational NutriNet-Santé cohort study, including on     December 2014 around 150,000 participants. The investigators will perform a five-arm     randomized trial where participants will be subjected to different FOP nutrition label     formats: Guidelines Daily Amount (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition     Label (5-CNL), Green Tick (Tick) and a 'no label' condition. The impact of front-of-pack     nutrition labels on the nutritional quality of the shopping cart will be assessed.     Participants from the NutriNet-Santé cohort study will be randomly assigned to one of these     five experimental conditions according to their sociodemographic characteristics.      Purchasing intentions will be assessed using an experimental web-based supermarket designed     to look like a regular online grocery store. The supermarket includes 269 unique products     divided into 4 categories: dairy products, processed meat/delicatessen, savory and     breakfast/sugary products. Each category is then separated into specific products families     like yogurt, milk, cheese, etc. for the dairy products category. Inside a food family, the     selection of foodstuffs will be made to obtain a representative sample of the products     commonly sold in French supermarket. For each type of products, at least two variants are     proposed. Products are retailers or manufacturers branded. Categories of products that are     not usually bought each week, or which are likely to be bought from different sources are not     included on the web-based supermarket.      Participants are asked to simulate a shopping situation: they have to select a week worth of     food for their family among proposed products. If the user is not able to find a product     he/she usually buy, the instruction is to select similar product among proposed ones.      Information provided for each product is: name, price and the picture with the FOP label/or     not according to the experimental condition to which the participant is allocated. A brief     explanation of the FOP label used is also given.   "
68755|NCT02385825|"     This study seeks to determine the safety and immunogenicity of a series of 3 primary     vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA     1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM. This study is evaluating if RVEc will     display an acceptable safety profile as determined by adverse event (AE) data and if RVEc     will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine     recipients.   "
68756|NCT02385812|"     Asbestos defines a group of naturally occurring mineral silicate fibers which are easily     inhaled, resulting in a variety of diseases of the respiratory system including lung cancer     and malignant mesothelioma. Despite some advances in treatment, there has been little impact     on overall survival for both lung cancer and mesothelioma in the past 20 years in great part     because patients usually present with disease at an advanced and incurable stage. This study     aims to develop and implement a low-dose computed tomography (LDCT) screening approach for     lung cancer and mesothelioma in asbestos-exposed workers in Alberta.   "
68757|NCT02385799|"     This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old     inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant     will receive a series of tests at both the beginning and end of the study. The researchers     hope to show improvements in language and social deficits.   "
68758|NCT02385786|"     This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive     Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from     baseline to completion of treatment at 8 weeks in terms of depression severity using the     Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of     inflammation, over the same time period.   "
68817|NCT02385019|"     Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host     disease after an allogeneic transplant of hematopoietic progenitors with donor     CliniMACS-selected regulatory T cells   "
69343|NCT02378129|"     The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and     compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT     (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White,     Gloucester, UK) at 2-year follow-up.   "
68759|NCT02385773|"     This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in     Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will     enroll children between the ages of 6 months and 3 years and will assess the impact of the     study nutrition product on the duration and severity of diarrhea and on weight recovery in     the 4 weeks following the diarrheal episode. The investigators will be determining the     etiology of the diarrhea episode to ascertain if the nutritional product works better for     certain etiologies or has a non-specific benefit.   "
68760|NCT02385760|"     A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and     safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.   "
68761|NCT02385747|"     100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to     transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional     curettage followed by histopathological examination and immunohistochemical analysis for     estrogen and progesterone receptors.   "
69976|NCT02369874|"     This is a randomized, open-label, multi-center, global, Phase III study to determine the     efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy     versus SoC therapy in the target patient population.   "
68766|NCT02385682|"     The purpose of this registry is to evaluate long-term clinical events in patients with acute     myocardial infarction who were treated with percutaneous coronary intervention.      Although numerous articles have been published by using nationwide Korean myocardial     infarction registries, such as the Korea Acute Myocardial Infarction Registry (KAMIR),     limitation of previous registries is that these have little data beyond the first year of MI.     Therefore, current registry was designed to assess long-term clinical events in patients with     acute myocardial infarction.      Because most of myocardial infarction patients were treated by revascularization in real     world of Korea, this registry limits the inclusion criteria to patients who were treated with     percutaneous coronary intervention to reduce the bias.   "
68768|NCT02385656|"     Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence     in cancer-patients.   "
68769|NCT02385643|"     Background: Interactive and mobile technology to manage alcohol use problem potentially     provide continuing care by offering emotional and instrumental support anywhere and in time,     but the effectiveness for maintaining abstinence has not been examined. the investigators     will evaluate in this study whether the smartphone-based support system would improve     outcomes for people in recovery for alcohol dependence. To enable continuous self-monitoring     and self-management, the phone support system prompts subjects to take Breath Alcohol     Concentration (BrAC) tests using a phone application and a Bluetooth sensor unit. The system     also offers instantaneous feedback, self-management strategies, and anonymous mutual social     support from other subjects.      Methods: This three-year project will be conducted in three stages, including pilot study,     efficacy evaluation (12 week), and post-intervention follow-up (12 week) stage. Participants     will be given a smartphone (if the subject does not have one), breathalyzer and training     session. In the pilot study stage,10 subjects will be enrolled to validate the system. In the     efficacy evaluation stage, the investigators will conduct a 12-week by enrolling 100     post-detoxification alcohol dependent patients who are randomized to (1) standard treatment     (ST) group or (2) standard treatment plus phone-based support group (technology intervention,     TI group). Participants will be assessed by Time-Line Follow-Back (TLFB) to record the     frequency and quantity of alcohol consumption, visual analogue for craving, Beck Depression     Inventory (BDI) and Beck Anxiety Inventory (BAI), Satisfaction with Life Scale (SWLS), and     Quality of life Scale (WHOQOL-BREF) and compared for outcome measures. After the 12-week     trial, the investigators will take back the support system and follow the all subjects in     both groups for another 12 weeks, i.e. post-intervention stage, to further understand the     sustaining benefit from intervention. In addition, the investigators will identify the     clinical variables or system factors that are associated with outcome measures.      Expected results: In this study, the investigators expect that in treatment-seeking alcohol     dependent patients, a smartphone-supported self-management program, adding on to conventional     treatment, will be beneficial in improving the drinking outcomes such as a higher abstinence     rate, a lower relapse rate, and a lower drinking frequency and quantity.   "
68770|NCT02385630|"     Surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but     while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best     chance of cure, these are major operations associated with specific long term complications.     Weight loss and poor nutrition are relatively common problems among patients who attain     long-term cancer remission and cure after surgery. The mechanisms underlying these problems     are not well understood and therefore treatment options are limited.      The investigators research has demonstrated increased levels of chemical messengers (gut     hormones) released from the gastrointestinal tract after meals in patients who have     previously undergone upper gastrointestinal surgery. These chemical messengers play a role in     signalling the feeling of fullness during and after a meal (satiety). Understanding the     mechanisms involved in increased gut hormone secretion after these operations may allow us to     use certain medications to block gut hormone release and hence reduce satiety allowing     patients to eat more, regain weight and prevent nutritional complications after surgery.      Exaggerated post-prandial satiety gut hormone responses following oesophagectomy have,     however, only been established cross-sectionally and therefore the time course for     development of increased gut hormone secretion is unknown. Data collected from this study     will provide important information about optimal timing of therapeutic intervention in this     patient group, while offering mechanistic insights with regard to the pathophysiologic     process underlying post-operative early satiety.   "
68771|NCT02385617|"     Improvements to treatment strategies for patients upper gastrointestinal cancers have     produced an increasing population of people who remain free from disease recurrence in the     long term. Weight loss and nutritional problems are common among patients who attain     long-term remission and cure after surgery for upper gastrointestinal cancers. However, the     mechanisms underlying these problems are not well understood. In this study the investigators     aim to determine whether reduced food intake after upper gastrointestinal surgery is caused     by early satiety related to exaggerated post-prandial gut hormone responses.      This is a randomized, double-blind, placebo controlled, crossover study of the effect of     100μg octreotide SC on ad libitum food intake in patients free from complications or     recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A     comparator group of age, weight and gender matched subjects will be studied concurrently, and     caloric intake and subjective symptom scores after administration of octreotide versus     placebo among surgical and comparator subjects will be assessed.   "
68834|NCT02384798|"     Due to the symptoms of heart failure (HF), as dyspnea and fatigue, patients have a reduced     functional capacity, evidenced during usual daily activities and exercises. The Cardiac     Rehabilitation with emphasis on resistance and aerobic exercises performed in the same     session (concurrent training), can be added to pharmacological treatment as improvement     strategy in functional capacity and quality of life.   "
68772|NCT02385604|"     A major focus of research in oncology is to identify patients who, following induction     therapy, have a complete pathologic response, presenting opportunities for novel trials,     including extended therapy or non-operative approaches, in addition to identifying cohorts     who are resistant to the neoadjuvant therapy. The current gold standard for determining     response to CRT is pathological evaluation following surgical resection, in particular the     Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however,     there is no preclinical early response or post-treatment biomarker, nor endoscopic or     radiologic assessment that predicts pathologic response prior to surgical resection.The aim     of this study is to determine the accuracy of CT-PET for prediction of histopathologic     response and/or oncologic outcome for patients with esophageal cancer.   "
68773|NCT02385591|"     This research aims to investigate the effectiveness of an automated Simple Message Service     (SMS, also known as text messaging) advisor system relative to a proven human advisor program     to promote regular, sustained physical activity among inactive, overweight Latinos. The SMS     Advisor program represents a potentially lower-cost and high yield alternative to     person-delivered health promotion programs that could be more rapidly disseminated with     greater and faster uptake.   "
76423|NCT02285517|"     This is a clinical trial study that compare two plastic surgery techniques in patients with     third degree of burning and both techniques are used in all patients but in different areas     of burning sites of the patients.   "
68774|NCT02385578|"     AIM Verified if the first stage of the Train the trainer (TTT)plan could improve the young     endoscopist's ability to detect the early gastric cancer（EGC）.      METHOD        1. a retrospective analysis of the ten young endoscopist's painless gastroscopy examination          from January 1, 2014 to December 31, 2014. According mainly to the endoscopic report and          pateint's History, quantity of gastroscope, gastric cancer and the early gastric cancer.        2. the first step of the train the trainer plan(TTT) activised in March 19-20,2015,which          including the diagnosis and operation hand in hand teach by Professor Yano          Takeshiin,and the case discussion,and so on. Five young endoscopist accepted the TTT          plan and the other five not accepted.        3. The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT          content (for the T1 period),.(1) the patient's name, (2)gender, (3)age,(4)past medical          history (Helicobacter pylori<HP>, gastritis, gastric ulcer, oral drug operation,          etc.),（5）gastroscope operation time,(6)the location of the lesion- longitudinal (upper,          middle and lower),(7) the location of the lesion -circumferential (lessor curvature,          Greater curvature, anterior wall, posterior wall),(8) lesion size, (9)conventional          white-light imaging (red, white, no change), (10)magnifying endoscopy with narrow-band          imaging (EM-NBI) microvascular and mirosurface pattern VS classification system(VSCS)          (boundaries, microvascular pattern and microsurface pattern; don't do it),          (11)microscopy types (uplift type, flat type, concave type or IIc I/IIa or IIb),          (12)histological type (differentiated and undifferentiated type) and (13) pathological          (low grade neoplasia, high-level neoplasia etc.). For the treatment of endoscopy          submucosal dissection (ESD) patients, further pathological results were recorded after          ESD, including the pathology, edge and basal conditions. The other five doctors do the          gastroendoscopy as they do before. (300 cases / person)        4. 2-4 TTT activity ;The five doctors who accepted the TTT do the gastroendoscopy in          accordance with the TTT content (for the T2-T4 period),.The other five doctors do the          gastroendoscopy as they do before.        5. Statistics the number of early gastric cancer have been found by the five young doctors,          and how mang gastroscopy they have done.pay attention to The rates of EGC detection.   "
68775|NCT02385565|"     The aim of the present study is to compare Resting Energy Expenditure (REE) between normal     fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial     cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced     thermogenesis (DIT) and body composition between NFD vs HFD.      This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids,     45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 %     lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation     criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry     ). 36 included MID subjects will be included in this study. Main evaluation criteria and     second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.   "
68776|NCT02385552|"     The purpose of this study is to determine clinical factors affecting quality indicators of     colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be     elevated by improving related factors.   "
68777|NCT02385539|"     To find the optimal dose and combination of small dose of Levobupivacaine (LB) coadministered     intrathecally with Fentanyl (F) or Sufentanil (S) with the highest probability for not     developing hypotension and the lowest opioid side effect that would be sufficient to achieve     and maintain a sensory block to the tenth thoracic dermatoma (T10) in elderly patients for     surgery lasting > 45 minutes as compared with large dose of Levobupivacaine alone.   "
68778|NCT02385526|"     Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability     and clinical outcomes study to determine the number of patients achieving their final     assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being     treated with adjunctive VNS Therapy using new titration protocols.   "
68779|NCT02385513|"     A single centre open-label, parallel group, randomised controlled trial, recruiting healthy     Nepalese infants aged 40-60 days, who present to the immunisation clinic at Patan Hospital,     Kathmandu, Nepal, randomised to receive a 10-valent pneumococcal conjugate vaccine (PCV10) at     either;        1. 6+10 weeks and 9 months OR        2. 6+14 weeks and 9 months The study will enroll 152 healthy Nepalese infants in each          treatment arm (304 in total). Demographic and clinical data will be collected on an          electronic case report form to allow monitoring remotely. Participants will receive the          study vaccine according to their allocated treatment arm in addition to their other          routine vaccines. The investigators will collect 3 blood samples for analysis of serum          antibody responses to the PCV10 vaccine serotypes throughout infancy (see Table 1). The          data collected will be analysed in order to determine whether the 6+10 schedule is          non-inferior to the 6+14 schedule in generating immune responses against the vaccine          serotypes above the ≥0•35μg/mL threshold. These data will then be used to inform          decision-making around augmenting the currently recommended 6+14 schedule to a 6+10          schedule in Nepal. The investigators will collect a nasopharyngeal swab at 2 time points          to look at carriage of pneumococcus over time and to assess differences between the 2          groups. This is of critical importance because much of the programmatic impact of PCV is          ultimately conferred by reductions in carriage at the community level and indirect          effects resulting from that NP protection.   "
68835|NCT02384785|"     Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In     recent years many studies had proved the effectiveness of electrical stimulation in pain     management, tissue healing and muscle strengthening. Today there are devices with many types     of currents. Each current comes with different statements for its effectiveness and its     penetration depth yet there is no consensus on the most effective current in the dimension of     penetration depth.   "
68780|NCT02385500|"     Parkinson's disease (PD) causes several non-motor autonomic symptoms including lower urinary     tract dysfunction. Their symptoms can be managed with antimuscarinics with variable efficacy.     Fesoterodine offers a new therapeutic molecule to target the symptoms of urinary frequency,     urgency and nocturia in this patient population. The purpose of this protocol is to compare     the impact of fesoterodine to placebo on urinary urgency and nocturnal sleep problems in a     heterogeneous population of PD patients in a cross-over fashion.      A representative number of patients with baseline overactive bladder (OAB) symptoms and     Parkinson's disease will be recruited to receive either the active drug or placebo for the     first phase of eight weeks. The groups will then be crossed-over during the second phase of     eight weeks. The main outcomes assessed will be the urgency episodes on a 3-day voiding     diary, as well as the nocturnal sleep problems will be the Parkinson's Disease Sleep Scale     (PDSS).   "
68781|NCT02385487|"     Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an     imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in     patients with critical illness and strongly associated with mortality, the pathophysiology     remains poorly understood. Inflammation is central to the development of atherosclerosis,     plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and     myocardial necrosis has not been defined. The investigators aim to to delineate the     mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical     medical illness.   "
68795|NCT02385305|"     The aim of this prospective study is to determine the effect of pressure support ventilation     (PSV) on minute alveolar ventilation (MAV) and end-tidal carbon dioxide (ETCO2) in     anesthetized spontaneously breathing subjects by observing alterations of respiratory rate     (RR), expiratory tidal volume, MAV and ETCO2 at variable levels of pressure support.   "
68782|NCT02385474|"     Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood     disease. Poor dentition significantly affects the nutrition, growth, development and general     health of children. Conventional dental care for ECC is neither affordable nor accessible,     particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe,     cost-effective caries-arresting agent that appears to conform to the World Health     Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically     used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an     evidence base. Therefore it is necessary to find the most suitable SDF concentration and     application interval to arrest ECC. The purpose of this randomised controlled trial is to     compare the efficacy of two commercially available SDF solutions at pre-prepared     concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months     in arresting caries in primary teeth.      Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4     years with caries. The sample size is sufficient for the appropriate statistical analyses.     The children were classified into high and low caries rates and equally allocated into four     groups for the caries treatment:      Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group     C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children     will be followed for 36 months in their kindergartens until they enter primary school.     Clinical examinations at 6-month intervals will be conducted to assess whether the caries are     arrested. Information on confounding factors, such as oral hygiene habits and the use of     other fluoride agents, will be collected through a parental questionnaire at the baseline and     follow-ups.      Discussion: This study will help determine the most suitable SDF concentration and     application interval to arrest caries in children. Because SDF use for caries arrest is     painless, simple, and low-cost, it can be widely recommended and promoted for caries control     in young children or those with difficulty accessing and affording conventional dental care.     The applicability of the findings and their impact on public health would be immense.   "
68783|NCT02385461|"     The occurrence of a spontaneous fetal loss (FL) is a rather frequent event: it has been     estimated that up to 15% of pregnancies result in a fetal loss. However, recurrent events,     defined as >2 or >3 loss, depending on the guidelines used (American College of Obstetricians     and Gynecologists or Royal College of Obstetricians Gynaecologists guidelines), occur in 1 %     of all pregnancies and it is noteworthy that Recurrent Fetal Loss ( RFL) in about 30-40% of     cases remain unexplained after standard gynaecological, hormonal and karyotype     investigations. Furthermore, it is important to consider that chromosomal abnormalities are     responsible for at least 60% of FL in the first trimester, thus an abnormal karyotype in the     fetus should be excluded prior to consider testing women for genetic susceptibility to     placental vascular complications (inherited thrombophilia).      Common inherited conditions, the factor V Leiden (FV) and the factor II G20210A (FII)     mutations have been recognized as risk factors for FL.      The efficacy of treatment with antithrombotic drugs during pregnancy in women with a history     of RFL/ Intra Uterine Fetal Death (IUFD) and thrombophilia is still debated, due to scarcity     of available data. Italian guidelines suggest the use of Low-Molecular-Weight Heparin (LMWH)     in women with FV or FII mutations and previous otherwise unexplained obstetric complications,     while guidelines released by RCOG suggest that heparin therapy during pregnancy may improve     the live birth rate in women with second trimester loss associated with inherited     thrombophilias. Hence, the idea to propose this prospective observational study comparing     clinical data and outcomes in women with common inherited thrombophilias and in women     without.      During this study the investigators will collect and evaluate clinical data from examinations     and visits by patients, eligible for the study as carriers of thrombophilic defects. This     observation will begin before pregnancy and continue until the puerperium, allowing us to     study all possible factors influencing these conditions. The study will add knowledge for     improving feto-maternal prognosis and preventing spontaneous and recurrent FL.      Plan of the study: multicenter observational study   "
68784|NCT02385448|"     The purpose of the study is to compare the recurrence of endometriotic cyst in patients     taking Dienogest or Microgynon after conservative surgery.   "
68785|NCT02385435|"     The aim of this prospective randomized double-blind study was to compare the analgesic     efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1)     co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children     undergoing infra-umbilical surgery.   "
68786|NCT02385422|"     To compare the efficacy and safety of Carvedilol and Propranolol in patients with     cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary     prophylaxis.   "
68787|NCT02385409|"     Preoperative anemia is an independent risk factor for the need for allogeneic transfusion     during surgery and increased postoperative morbidity.      Treatment of preoperative anemia is recommended. However the type of preoperative anemias in     elective hip- and knee surgery has only been sparsely studied.      This observational study aims to investigate the incidence and type of anemias prior to     elective hip- and knee arthroplasty.   "
68788|NCT02385396|"     The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate,     embryo development dynamics and oestradiol and progesterone concentration in blood serum and     Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with     Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).   "
68789|NCT02385383|"     This observational study follows a cohort of patients scheduled for elective hip- or knee     surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to     surgery according to a recently introduced standardized treatment protocol at 6 high-volume     surgical centres.   "
68836|NCT02384772|"     Survey to assess perspectives of patients prescribed IOP-lowering eye drops at a single     office visit.   "
68790|NCT02385370|"     Patients with advanced glaucoma that are candidates for trabeculectomy will be included.      Thorough ophthalmic examination including best corrected visual acuity, slit lamp     examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly     microscopy will be performed for all participants. Patients will be assigned randomly to 2     groups. In one group they will undergo fornix based trabeculectomy with conventional MMC     0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into     the tenon at the beginning of the surgery. The rest of the operation is the same for both     groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be     performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at     final follow up visit. Bleb morphology will be scored according to Indian grading system at     3rd and 6th months post surgery.   "
68791|NCT02385357|"     There is no conclusive evidence about the effect of intake of protein-enriched drink after     and acute high intensity exercise bout on muscle function and damage. The investigators aimed     to study the effect of a protein-enriched drink on muscle function recovery following an     acute high intensity exercise bout. The present counterbalanced, crossover, and double blind     study will involve a total of 12 active men.   "
68792|NCT02385344|"     The purpose of the registry is to collect information regarding the number and type of     coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative     guidance information using transit time flow measurements (TTFM) and ultrasound image     capabilities provided with the Medistim device.   "
68793|NCT02385331|"     Neutrophils play a central role in innate immunity and are rapidly recruited to sites of     infection and injury. Neutrophil apoptosis and necroptosis are essential for the     inflammatory.This study is designed to investigate the cells and the molecular mechanisms of     neutrophil necroptosis and apoptosis.   "
68794|NCT02385318|"     The purpose of this study is to compare safety and efficacy of Perrigo's drug product     compared to an FDA approved drug product in the treatment of actinic keratosis.   "
68796|NCT02385292|"     The objectives of this study are:        -  To compare the change in levels of tear proteins and inflammatory mediators pre and post          administration between the intranasal and extranasal applications        -  To compare the goblet cell count following application between the intranasal and          extranasal applications        -  To compare fluorescein tear clearance with the application of the device intranasally          and extranasally applications   "
68797|NCT02385279|"     The primary objective of this study is to compare the performance of MISTENT to that of     XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The     patients will be followed through 3 years for major clinical events.   "
68798|NCT02385266|"     The purpose of this study is to evaluate the efficacy of D-Cycloserine versus placebo     treatment in reducing pain from urological chronic pelvic pain syndrome (UCPPS).   "
68799|NCT02385253|"     This is a four-phase educational intervention for primary care practitioners (PCPs) to     perform opportunistic melanoma surveillance. Based on prior research, the investigator will     develop an interactive melanoma early detection skills training program for PCPs according to     the principals of mastery learning. The proposed educational intervention will improve     practicing PCPs' knowledge, competence, confidence, and diagnostic performance regarding     pigmented lesions and attitude concerning importance of skin surveillance. In addition, this     research aims to examine the clinical proficiency of PCPs regarding pigmented lesions. The     proposed educational intervention will reduce the percentage of benign lesions referred to     dermatology.   "
68800|NCT02385240|"     To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved     rosacea drug product in the treatment of facial erythema of rosacea.   "
68801|NCT02385227|"     This is a randomized, open-label, forced-switch, parallel, proof-of-concept study to assess     exposure to biomarkers of tobacco exposure following short-term ad lib use of three blu     e-cigarette products. The primary objectives of this study are to:        1. Compare changes in selected urine and blood biomarkers of tobacco exposure within          cohorts following a 5-day forced-switch from usual brand conventional combustible          cigarettes to exclusive use of blu e-cigarettes, dual use of blu e cigarettes and the          subject's usual brand combustible cigarette, or smoking cessation.        2. Compare changes in selected urine and blood biomarkers of tobacco exposure among cohorts          following a 5-day forced-switch from usual brand conventional combustible cigarettes to          exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's          usual brand combustible cigarette, or smoking cessation.      The secondary objectives of this study are to:        1. Compare changes in selected physiological endpoints affected by tobacco exposure within          cohorts during a 5-day forced-switch from usual brand conventional combustible          cigarettes to exclusive use of blu e cigarettes, dual use of blu e cigarettes and the          subject's usual brand combustible cigarette, or smoking cessation.        2. Compare changes in selected physiological endpoints affected by tobacco exposure among          cohorts following a forced-switch to exclusive use of a blu e cigarette, dual use of a          blu e-cigarette and the subject's usual brand combustible cigarette, or smoking          cessation.        3. Determine daily nicotine consumption from blu e-cigarettes following exclusive use of          blu e cigarettes or dual use of blu e-cigarettes and the subject's usual brand          combustible cigarette over a 5-day period.        4. Assess the effectiveness of exclusive use of blu e-cigarettes or dual use of blu          e-cigarettes and the subject's usual brand combustible cigarette to reduce the urge to          smoke.        5. Assess subject opinions of various characteristics of blu e-cigarettes.        6. Assess the safety and tolerability of short-term use of blu e-cigarettes.   "
68802|NCT02385214|"     Patients with a primary invasive melanoma are recommended to undergo excision of the primary     lesion with a wide margin. There is evidence that less radical margins of excision may be     just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of     the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick     to determine differences in the rate of local recurrence and melanoma specific survival. A     reduction in margins is expected to improve quality of life in patients   "
68803|NCT02385201|"     This is a prospective, multi-center feasibility study of effectiveness and safety of the     Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. Data     at follow-up visits will be compared to Baseline data collected at the beginning of the     study.   "
68804|NCT02385188|"     The purpose of this study is to evaluate the efficacy, safety and immunological response of     topical 5% imiquimod cream for non-invasive vulvar Paget's disease.   "
68831|NCT02384837|"     Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared     with bare metal stents, late stent thrombosis (LST), a life-threatening complication of this     technology, has emerged as a major concern. Researches indicated incomplete neointimal     coverage of stent struts as the most important morphometric predictor of LST. Pathological     research showed stenting disruption of adjacent vulnerable plaques can precipitate LST,     Meanwhile, thin-cap fibroatheromas (TCFA) as the most important predictor of Major Adverse     Cardiovascular. Therefore, there is a hypothesis that TCFA may impair intimal healing which     are prone to LST in vivo.      Optical coherence tomography (OCT)is a high-resolution (<10 µm), catheter-based imaging     modality capable of investigating detailed coronary plaque morphology in vivo.This study     aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts     on the lesions which fractional flow reserve (FFR)≤0.75 after EXCEL biodegradable     polymer-coated sirolimus-eluting stent was implanted at 9 months follow up: evaluated by OCT     and FFR   "
68805|NCT02385175|"     The Eustachian tube links the middle ear to the back of the nose and is designed to open to     allow the pressure in the air-filled middle ear to be equal to external (atmospheric)     pressure. In some people this system fails to work properly leading to abnormal pressure in     the middle ear, and complications such as middle ear fluid ('glue ear') or damage to the ear     drum. The abnormal function of the Eustachian tube is called 'Eustachian tube dysfunction'.     An affected person may feel pressure, pain or other symptoms in their ear, and their hearing     can be temporarily or permanently reduced.      This study is designed to find out which of a number of simple tests is best at detecting if     the Eustachian tube is performing normally. Both patient-completed questionnaires and     clinical tests using specialist machines will be compared as a way of diagnosing Eustachian     tube dysfunction.      A group of adults aged 18 and above, and children aged 5-17 years with normal ears, and a     similar group of people that are already known to have Eustachian tube dysfunction, will both     take six different tests and complete four different questionnaires. The differences in the     results between the group with ETD and the healthy group will be compared. The results for     each test or questionnaire will be compared to see which is best at telling the healthy and     Eustachian tube function groups apart, and therefore at diagnosing Eustachian tube     dysfunction. The investigators will also look to see if a combination of one or more of the     tests or questionnaires is best at diagnosing the disease.      The results of this study hope to provide a test or combination of tests that can be used on     a daily basis by ENT doctors. The assessment technique would also be helpful in researching     and comparing new treatments for ETD.   "
68806|NCT02385162|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Glycogen     Storage Diseases from plasma and saliva. Testing for clinical robustness, specificity and     long-term stability of the biomarker.   "
68807|NCT02385149|"     This study investigates the health benefits of whole grain wheat on cardiovascular/     cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal     challenge. This study also investigates the health benefits of whole grain wheat (WGW) on     liver- and adipose tissue health and evaluates the potential of do-it-yourself (DIY) devices     in quantifying health effects in a nutritional intervention study.   "
68808|NCT02385136|"     The purpose of this study is to evaluate the safety profile and efficacy of whole brain     radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases     (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ     (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).   "
68896|NCT02383992|"     The primary objective of this study is to compare the efficacy of hydrogen peroxide versus     normal saline in postoperative care of sutured wounds. Subjects will be randomly assigned to     standard of care hydrogen peroxide or standard of care normal saline in postoperative care of     sutured wounds followed by applying petroleum jelly and sterile gauze bandage. Data will be     collected at day 0 and between days 7 to14. Subjects will provide irritation scale rating     (0-4) with 0 being none/absent and 4 being severe/extreme.   "
68809|NCT02385123|"     This is an open label single arm observational study of longitudinal immunologic responses to     influenza vaccine in healthy adult subjects. This study will enroll males and non-pregnant     females, 18-49 years old. The subjects will be screened at enrollment with a history and     physical exam and laboratory testing to ensure they are healthy enough to participate.     Qualifying subjects will be vaccinated with an FDA approved seasonal inactivated influenza     vaccine (IIV) according to the package insert. The study will enroll 10 healthy volunteers     per vaccination season in years 1, 2 and 4 through 6 of this study, for a total enrollment of     50 subjects. The primary objective of the study is to characterize HA-specific plasmablasts     and memory B cells after influenza vaccination.   "
68810|NCT02385110|"     The goal of this clinical research study is to compare the effect of adding either     alemtuzumab or tocilizumab to the drug combination of etoposide and dexamethasone in     controlling HLH. The safety of the drug combinations will also be studied.   "
68811|NCT02385097|"     This Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference     product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for     distal upper limb surgeries, without any supplementation in the first 45 min (see definitions     below), calculated from the time of readiness for surgery (complete sensory block).     Successful block: anaesthesia adequate for the surgery (complete sensory block), without any     supplementation in the first 45 min (even if surgery lasts for > 45 min), calculated from the     time of readiness for surgery (complete sensory block). Supplementation: i.v. premedication     or general anaesthesia or pre- or intra-operative systemic analgesia or additional local     anaesthetic infiltration   "
68812|NCT02385084|"     The purpose of this study is to measure how much of the new LY2409021 tablet formulations get     into the blood stream and how long it takes the body to get rid of them, compared to the     current LY2409021 capsule formulation. In addition, the safety and tolerability of both the     new and current formulations will be evaluated. Information about any side effects that may     occur will also be collected. The study has two parts. Each participant may enroll in one     part only. The study will last up to 8 weeks for each participant. Screening is required     prior to the start of the study.   "
68813|NCT02385071|"     The purpose of this study is to assess the relative bioavailability (the extent to which a     drug or other substance becomes available to the body) of simeprevir (SMV) following single     dose administration of age-appropriate oral formulation candidates compared to the 150     milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV     following single dose administration of a selected age-appropriate oral formulation     candidate.   "
68814|NCT02385058|"     The purpose of this study is to assess the efficacy and safety of the combination of     mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in     Mexican population.   "
68815|NCT02385045|"     This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate     and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and     comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band     imaging (NBI) and histology.   "
68816|NCT02385032|"     The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.   "
68832|NCT02384824|"     The purpose of this study is to characterize the plaque morphology in patients with acute     STEMI by OCT after aspiration thrombectomy.   "
68818|NCT02385006|"     Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization,     no modifications of the usual care, study results are not available for the physicians in     charge of the patient.      Objectives:        -  The main objective of this study is to evaluate the ability of the thromboelastogram          (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation,          comparing ROTEM ® profiles during the perioperative period of two different types of          transplantation (kidney alone and simultaneous pancreas-kidney)        -  The secondary objectives are:             1. To assess the incidence and type of coagulation disorders during the perioperative               period of these two types of transplantation             2. To study correlation values between thrombolelastogram and standard coagulation               parameters      Population study:        -  Evaluated group: 40 pancreas-kidney recipients        -  Control group: 80 kidney recipients        -  Recruitment periods: 24 months        -  Patient Monitoring: 48 hours        -  Total duration of the study: 36 months.        -  Ethics: Study of routine care. Oral and written information given to patients.          Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol          No. HCL / P 2012.727)   "
68819|NCT02384993|"     The purpose of the aeRobic Exercise and Cognitive Health (REACH) study is to understand how     an aerobic exercise intervention might help promote brain health and cognition, thereby     delaying the onset of clinical symptoms of Alzheimer's disease.   "
68820|NCT02384980|"     This study will take the first step to improve public health for millions of Americans with     Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The     investigators will assess a proof of concept, home administered, functional electrical     stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.   "
68821|NCT02384967|"     Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in     HIV-1 infected patients virologically suppressed under a once daily regimen including     darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain     the viral load lower than 50 copies / mL at 48 weeks of treatment.   "
68822|NCT02384954|"     This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation     study of ALT-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in     conjunction with rituximab.   "
68823|NCT02384941|"     This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin High dose     or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when     used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate     glycemic control with insulin therapy.   "
68996|NCT02382679|"     The purpose of this study is to assess the efficacy of vitamin therapy in concussion when     compared to placebo with respect to multiple endpoints including symptom severity, cognitive     performance on computer based neuropsychological testing, post-concussion balance assessment,     and post-concussion vestibular-oculomotor function.   "
68824|NCT02384928|"     This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for     severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual     care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with     severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, 4 weeks - 6 months) will     be recruited, and randomized 20 each to the Shinbaro pharmacopuncture, acupuncture, and usual     care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of     acupuncture alone or with pharmacopuncture for 4 weeks, and the usual care group will receive     conventional medication 2 times/day and 2 sessions/week of physical therapy. Post-treatment     evaluations will take place 5, 7, 9, and 12 weeks after randomization.   "
68825|NCT02384915|"     The aim of the study is to compare the time of home discharge in day-case patients receiving     either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy   "
68826|NCT02384902|"     low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared     with conventional diet.      low GL may have more favorable effect than low GI diet.   "
68827|NCT02384889|"     This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase 1     clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study     enrolling patients with new onset type 1 diabetes with documented continued residual     C-peptide production. After a 4 week screening and run-in period during which eligibility     will be determined and glycemic control optimized, subjects will have a 3-month double-masked     treatment period with either DFMO or placebo. After a 3 month wash-out period the durability     of effect will be assessed. Subjects will be randomly assigned (6 to DFMO; 3 to placebo in     each cohort) to 1 of 4 sequential dose cohorts.   "
68828|NCT02384876|"     The incidence of arterial hypotension under general anesthesia using sevoflurane is     particularly high in newborns and infants up to 6 months of age. A decrease of 20% of the     initial mean blood pressure (mBP) is the definition of significant arterial hypotension in     adults and children. In adults, intraoperative arterial hypotension is associated with an     increase of intraoperative mortality and a certain neurological morbidity. In infants under 6     months of age, neurological disorders have been reported following general anesthesia.     Neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial     hypotension.      Current management of hypotension uses vascular filling with crystalloids and vasopressive     amines in second intention. Dopamine is the most frequently used amine. Ephedrine can also be     used. Ephedrine is particularly interesting because of its action on both α and β receptors     and its mode of administration: one dose and peripheral access.      Only one study is available in children from birth to adulthood; it demonstrates a lower     hemodynamic response in infants than in adults, when administered a low dose of Ephedrine     (0.1 to 0.2 mg/kg). A recent retrospective cohort suggests an under efficacy of low doses and     the use of higher doses than those recommended.      The primary objective is to determine the optimal dose of ephedrine (dose of ephedrine     associated with a difference of proportion of newborns/infants in therapeutic success of 55%)     compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative     arterial hypotension.      Secondary objectives:        -  Return to a mBP superior to 38mmHg post Ephedrine administration.        -  To assess occurrence of hypoxemic events during anesthesia.        -  To assess tolerance of ephedrine. One hundred and twenty newborn and infants up to 6          months of age will be recruited in 3 sites of the Rhone Alpes Auvergne area over 24          months.   "
68829|NCT02384863|"     The purpose of this study is to describe the characteristics, evaluation, management and     outcomes of acute chest pain, and to provide opportunities for future initiatives to improve     the emergency care for patients experiencing acute chest pain in China.   "
68830|NCT02384850|"     This trial will evaluate the combination treatment of established chemotherapy regimen     mFOLFOX6 with Selinexor, an oral Selective Inhibitor Of Nuclear Export, in patients with     metastatic Colorectal Cancer. The purpose is to determine the maximum tolerated dose (MTD) of     selinexor in combination with mFOLFOX6.   "
68925|NCT02383615|"     Saphenous nerve blocks can be technically challenging. Recently described ultrasound     techniques have improved the success rate of saphenous nerve blocks, but randomized     controlled trials comparing these techniques are lacking. The investigators compared two     common ultrasound guided approach for saphenous nerve block: saphenous nerve block at the     adductor canal (ACSNB) vs. block by the distal trans-sartorial (DTSNB) approach.   "
68838|NCT02384746|"     Participants in this study will have been diagnosed with advanced breast cancer that has     become worse while being treated with fulvestrant. Participants will have estrogen-receptor     positive disease, and have completed menopause.      There is information from research labs which suggests that drugs that work like MLN9708 help     kill breast cancer cells that have been treated with fulvestrant. The purpose of the study is     to determine the proper dose as well as the good and bad effects of MLN9708 when it is given     in combination with fulvestrant. The Investigators also want to learn more about how the drug     combination affects tumor cells.      The amount of MLN9708 participants receive will be determined by when they enter this study.     Three different doses will be given to different participants. The Investigators expect to     enroll a total of 12-18 people.   "
68839|NCT02384733|"     The purpose of the study is to investigate the difference in late radiation morbidity between     hypofractionated and normofractionated loco-regional breast irradiation irrespective of     mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be     provided as a simultaneous integrated boost.   "
68840|NCT02384720|"     The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship     between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG     approximate entropy, systolic BP, saturation wave form and invasive BP wave form.   "
68841|NCT02384707|"     Reintroduction of small doses of food in allergic children to lightening the elimination     diet.   "
68842|NCT02384694|"     The aim of this study is to examine the effects of a 12-week Zumba dance intervention on     fitness, anthropometric and psychometric parameters and eating behavior.   "
68843|NCT02384681|"     Auditory monitoring of employees is currently based on pure-tone audiometry. However, this     clinical examination does not prevent from deafness but established it a posteriori. From a     preventive standpoint, it is important to detect hearing professional pain before the     development of irreversible(s) clinical(s) symptom(s). The investigators' hypothesis is that     auditory fatigue results from damages of primary and secondary central auditory pathways     involving cognitive processes.      The assessment of auditory fatigue includes the evaluation of speech intelligibility,     short-term memory, working memory and perceived mental task load. The main objective of this     study is to identify, among regulating medical assistants working with headset, a central     auditory fatigue.   "
68844|NCT02384668|"     The purpose of this study is to investigate the effects of vitamin D supplementation on     morbidity and risk of relapse in patients with Graves' disease.   "
68845|NCT02384655|"     Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal     intensive care unit acquired morbidity such as NEC and the late onset sepsis.      It is often difficult to obtain sufficient quantities of human milk from mothers of preterm     infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use     galactogogues in an attempt to increase milk production. Fenugreek (Trigonella     foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the     pea family. Our experience at the NICU is that around 30% of preterm mothers desperately     looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe)     as food supplement. Although widely recommended, there is limited evidence to support the     effectiveness of fenugreek as a galactogogue.      The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has     any effect on macronutrients composition of breast milk and whether fenugreek is transferred     to the infant via mother milk. In addition any changes in mother and infant health status     will be assessed.   "
68846|NCT02384642|"     The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls     in Eastern Democratic Republic of Congo. The study design will employ a two-arm randomized     controlled trial where girls will be enrolled at the same time and randomized to receive a     basic package of services, which includes life skills education and access to mentors in safe     spaces, or the basic package plus a structured parenting intervention for girls' caregivers.     An experimental design will be used to evaluate the relative impact of the parenting     initiative in addition to the safe space program for girls. In addition, qualitative research     will address additional questions of acceptability, processes of change and best practice.      Groups in North and South Kivu will be randomized so that every group is randomly designated     as a group that will either roll out the core intervention or the intervention plus caregiver     component. Groups that do not receive the parental intervention during the study will receive     the intervention when the study is complete to reduce communal jealousies.      The intervention, the COMPASS program, will involve a structured intervention for girls     between the ages of 10-14 that is intended to engage adolescent girls, those who are     influential in their lives, service providers and other stakeholders, with the ultimate goal     of co-creating environments in which girls are valued and safe. The program is centered on     establishing or supporting community-supported safe spaces for girls where they can come and     gather among themselves and participate in a structured life-skills curriculum. In addition     to the safe spaces for girls, the COMPASS project will also implement structured activities     for the parents and caregivers of participants.   "
68847|NCT02384629|"     1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients          with coronary artery bifurcation disease        2. To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes          following the stent type   "
68848|NCT02384616|"     This study is aiming at assessing the effect of inspired oxygen fraction during general     anesthesia on children's lung mechanics and volume. More specifically, the temporal change in     end-expiratory lung volume (EELV) and respiratory system resistance and elastance during the     perioperative period will be characterized in order to define the the effect of high inspired     fraction of oxygen on lung function.   "
69391|NCT02377505|"     This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for     treatment of patients with treatment resistant schizophrenia, by means of a random,     controlled and crossed study.   "
68850|NCT02384590|"     Patients with sickle cell disease (SCD) experience significant depressive symptoms that     currently go unrecognized and under-treated. Further, depression in this patient population     has the potential to contribute to high health care utilization and poor disease outcomes;     however, there are currently no comparative effectiveness studies of evidenced-based mental     health treatments for depression in SCD.      The primary objective of this study is to test the effectiveness of an online computerized     cognitive behavioral therapy intervention to address psychological and behavioral needs of     patients with sickle cell disease, namely depression and pain symptoms. The investigators     will implement an existing computerized cognitive behavioral therapy (CCBT) program called     Beating the Blues into routine clinical care at the University of Pittsburgh Medical Center     (UPMC) Adult Sickle Cell Clinic to determine the effectiveness of this intervention in     decreasing depression and pain versus treatment as usual. Patients with significant     distress—depression and/or anxiety symptoms—will be randomized to either eight sessions of a     CCBT program and weekly follow-up with a care manager or treatment as usual where the     treating physician is notified of the patient's symptoms. The investigators will evaluate     patient acceptability, implementation and practicality of the online mental health     intervention through patient use of the site (frequency and duration of visits), qualitative     interviews, and surveys. The investigators hypothesize: 1) the CCBT will be an acceptable     mental health treatment for patients and easily integrated into routine clinical care; 2)     patients in the treatment arm will show a greater decrease in depression/anxiety symptoms and     average daily pain than patients in usual care.   "
68851|NCT02384577|"     The main aim of the study is to investigate patient satisfaction in the treatment of asthma     and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible     difficulties in the use of the device under real-life conditions in clinical practice are     investigated.   "
68852|NCT02384564|"     The purpose of this study is to determine whether there is a clinically relevant difference     in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct     Laryngoscopy in Children.   "
68853|NCT02384551|"     4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on     gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.   "
68854|NCT02384538|"     This is a multicenter, randomized, double-blind, placebo-controlled study to compare the     safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.   "
68855|NCT02384525|"     Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of     critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI     are widely treated with Continuous renal replacement therapy (CRRT). However, previous     studies have hardly documented improvement of mortality in septic AKI patients. Otherwise,     Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant     predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis     and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study     is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be     related to the outcome of septic AKI patients who undergo CRRT. In this study, the     investigators measure the fluid status of the patients by bioelectrical impedance analysis     and lung ultrasound for experimental group, while for control group, fluid status would be     determined clinically by the physician. Ultrafiltration rate of experimental group is     adjusted to be equal to the value of overhydration measured by BIA.   "
68856|NCT02384512|"     End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and non-motor     Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with the next     dose of anti-parkinsonian medication. Azilect® is approved and recommended for therapy of     wearing-off-/End-of-dose fluctuations and improves motor fluctuations significantly in     combination therapy with L-dopa and other parkinsonian medication.   "
68857|NCT02384499|"     -  Purpose: The investigators aimed to investigate the safety and efficacy in the treatment          of fecal incontinence by injection of ALLO-ASC into the anal sphincter.        -  Method             1. Safety test of allogenic ASCs injection             2. Efficacy test of allogenic ASCs injection   "
68858|NCT02384486|"     This study aims to reduce stress in mothers of children with autism in Saudi Arabia. The     researcher has designed a training programme for mothers whose children are young and just in     their early stage at the autism organisations they are attending. The programme will include     stress reduction tips, behavioural modification strategies for children with autism, and     financial resources available to parents (how they can access government funding). The study     will have two parts. Part one involves conducting an experiment by dividing the participants     into two groups, one group will receive the training and the other group will wait until the     end of the study then they will also receive the same training. Both groups will fill     questionnaire at the beginning of the study, then after the first group finishes training,     and then again 6 weeks later. Part two of the study will involve interviewing mothers of the     first group who attended the training session. They will be interviewed by the researcher     asking them about their experience with the training programme and their suggestions for     future improvements. Mothers will be given a training manual at the beginning of the     training. Training involves attending five sessions, one of which is a face to face session     at the autism organisation their children are attending and the other four sessions will be     through a Smartphone application called whatsapp which is widely used in Saudi Arabia.   "
68859|NCT02384473|"     This pilot clinical trial studies real-time contrast-enhanced ultrasonography and shear wave     elastography in predicting treatment response in patients with soft tissue sarcomas.     Ultrasonography and elastography are diagnostic imaging tests that use sound waves to make     pictures of the body without using radiation (x-rays). Real-time contrast-enhanced     ultrasonography and shear wave elastography may help measure a patient's response to     treatment given before surgery in patients with soft tissue sarcoma.   "
68860|NCT02384460|"     The aim is to assess the efficacy and safety of SD-101-6.0 cream versus SD-101-0.0 (placebo)     in the treatment of patients with Epidermolysis Bullosa. Funding Source - FDA OOPD   "
68977|NCT02382926|"     In this trial contactless heart rate, electrocardiography and breathing rate measurements are     elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.   "
68861|NCT02384447|"     The investigators are proposing to conduct this study to compare the ultrasonographic     appearance of the sciatic nerve with their corresponding histologic architecture. Patients     that are scheduled to undergo above knee amputation due to complications associated with     diabetes will be enrolled. We intend to do an ultrasound examination of the sciatic nerve at     its bifurcation (about 4 inches above the knee). The investigators would mark the area on the     skin where the image is obtained. Following surgery we will conduct a histologic examination     of the nerve at the same site.      Ultrasound examination is not standard of care, but is a fairly noninvasive procedure and     does not add any risk to the subject. Histologic examination of the nerve is also not     standard of care, but is conducted on a pathology specimen   "
68862|NCT02384434|"     This single-arm phase I/II study establishes the safety and efficacy of low level laser     therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing     radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives     include assessment of patient-reported quality of life data, pain parameters and dermatologic     quality of life responses. The target population is patients with histologically proven     squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are     candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and     concurrent radiation therapy.      Patients are required to have a favorable performance status (KPS greater than or equal to     70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to     provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients     will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least     nine treatment sites in the head and neck region for a duration of 60 seconds to each site.     LLLT will be given three times in a week prior to, daily during the first week of, and at     least twice weekly thereafter during radiotherapy.      Information collected includes toxicity scoring and quality of life surveys. A retrospective     matched-pair design will be used to assess the rate of grade III complications compared to     patients treated previously without LLLT support, with an anticipated 20% reduction in the     risk of grade III dermatitis.   "
68863|NCT02384421|"     Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs     in Parkinson's disease. Currently, cDBS is limited to open-loop stimulation, without     real-time adjustment to the patient's state of activity, fluctuations and types of motor     symptoms, medication dosages, or neural markers of the disease. The purpose of this study is     to determine if an adaptive DBS system,responding to patient specific, clinically relevant     neural or kinematic feedback, is more effective than continuous DBS on the motor Unified     Parkinson's Disease Rating Scale (UPDRS III) and specific phenotypic measures in Parkinson's     Disease.   "
68864|NCT02384408|"     Healthy postmenopausal women, amenorrheic for 1-10 years, aged 45-60 years and in use of     follicle stimulating hormone > 30 mille-International unit/milliliters (mIU/mL), will     participate in the study.      All women will be informed by a physician of the risks and possible benefits of Hormone     Replacement Therapy (HRT).      The continuous combined treatment with drospirenone 2 mg and 17β-estradiol 1 mg or tibolone     1.25 mg will be administered for a 24-week period.      Transvaginal ultrasound was performed to evaluate the thickness of the endometrium at     baseline. At study end-point, an endometrial biopsy will be performed with a Pipelle     endometrial sampler to examine histological and immunohistochemical parameters.      Immunohistochemical detection of Bcl-2 protein, estrogen and progesterone receptors will be     performed in stroma and glandular epithelium.   "
68865|NCT02384395|"     This is a multicenter, single arm, 96-week open-label study of the safety and virologic     efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC)     initiated during acute HIV infection (AHI).   "
68866|NCT02384382|"     The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography /     computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response     in metastatic bone lesions in patients who are receiving enzalutamide for     castration-resistant prostate cancer.   "
68867|NCT02384369|"     This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects     with cPTSD, added to pre-existing treatment that includes prazosin with or without other     psychotropic drugs.      Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks.     Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder     (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the     response to placebo.   "
68868|NCT02384356|"     The purpose of the study is to gather baseline surveillance data about the current health     status of adults with chronic health conditions in La Paz and El Alto, Bolivia and identify     barriers to the management of NCDs during face-to-face outpatient encounters as well as via     novel mobile health services.   "
68869|NCT02384343|"     The purpose of this study is to determine whether dexmedotomidine is effective in the     treatment of shivering associated with neuraxial anesthesia during cesarean delivery.   "
68870|NCT02384330|"     This study aims to estimate the costs of botulinum toxin A utilization in standard practice     for the treatment of upper limb spasticity post-stroke in Portugal.      It will consider the three most used locally available brands of botulinum toxin A which show     similar efficacy and safety profiles thus making it relevant to understand if choosing     between one or another brand can depend directly on economic factors.      The study will estimate direct and indirect drug-associated costs as determinant variables     for the price of each drug and the standard drug dose used in clinical practice.   "
68871|NCT02384317|"     This is a pilot study to test safety, tolerability, and efficacy of CCX168 in reducing     proteinuria in patients with Immunoglobulin A nephropathy and persistent proteinuria despite     supportive therapy with a maximally tolerated RAAS blocker.   "
68872|NCT02384304|"     The purpose of this study was to determine whether a 10-week internet-based program based on     cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if     having therapist guidance leads to greater effects.   "
68997|NCT02382666|"     The purpose of this study is to assess the safety and tolerability of single increasing doses     of intravenously administered rolapitant in healthy male and female subjects.   "
76424|NCT02285504|"     This is an open-label proof-of-concept study designed to evaluate the safety, tolerability,     PK, and efficacy of SAGE-547 Injection in adult female patients diagnosed with severe     postpartum depression (PPD).   "
68873|NCT02384291|"     This clinical study is designed to compare the regenerative outcome of using separately two     different Xenografts during sinus floor augmentation.      Aim of this prospective randomized-controlled clinical trial is to compare the regenerative     results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft     after two-step sinus floor elevations by clinical and histological analysis.      Clinical Parameters are wound healing parameters, radiological volume stability and implant     survival rates. Histological parameters are based on a histomorphometrical analysis of     trephine cores harvested in progress of implant bed preparation.   "
68874|NCT02384278|"     The purpose of this study is to determine whether internet based cognitive behavior therapy     might be effective in the treatment of alcohol problems.   "
68875|NCT02384265|"     Diabetes is a major public health problem that is associated with substantial health     disparities for African American women compared to African American men or white men and     women. This project will incorporate a) new technology whose use is high among African     Americans (cell phone text message reminders), b) support from social networks, and c)     strategies from the emerging field of behavioral economics to encourage and support self care     behaviors that lead to improvements in diabetes control.      In Stage I of the study, the investigators conducted focus groups with women with diabetes     and their family members and friends. The investigators used information from these groups to     work with a team of community partners to develop recruitment protocols, prepare study     documents (including flyers, Frequently Asked Questions sheets, and informed consent forms),     and finalize participant surveys.      In the next phase of the study the investigators will evaluate ways that friends and family     members can use direct support and text messages to improve control of blood sugar for     African American women with type 2 diabetes. A team of three people--the Person With Diabetes     (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be     assigned at random to one of two groups to compare approaches to improving control of blood     sugar. Each team will receive information and resources on improving diabetes control and     will be linked by a text messaging program. The intervention team will receive additional     text messaging support that may help them improve the PWD's diabetes control.   "
68876|NCT02384252|"     The investigators aim to explore obese cardiomyopathy by studying contractile twitch force,     sarcomere sensitivity to calcium and mitochondrial function in atrial myocardial samples of     patients grouped according to their body mass index, i.e. normal weight, overweight and     obese.   "
68877|NCT02384239|"     Approximately 70 patients with HR+ advanced breast cancer will be enrolled. All patients will     receive either fulvestrant (500 mg IM every 2 weeks x 3 then every four weeks) or tamoxifen     (20 mg PO daily by physician choice). Pre-menopausal women must be in chemical menopause.      Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive     palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks.     Therapy will be continued until PD or unacceptable toxicity.      Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of     palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by     our collaborating statistician at Dana-Farber Cancer Institute.   "
68878|NCT02384226|"     Refine content and delivery of the mHealth delivered lifestyle intervention program through     iterative testing with small groups of users who provide feedback through on-line     asynchronous focus groups.   "
68879|NCT02384213|"     The main objectives of this study are: i) to investigate the incidence and prevalence of     fatal and non-fatal heart failure (HF) following myocardial infarction (MI) and its evolution     over time in men and in women; ii) to identify prognostic factors for developing HF in     patients who had an MI.   "
68880|NCT02384200|"     When patients are going to have surgery to remove large kidney stones (percutaneous     nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of     prophylactic preoperative oral antibiotics; currently both the use of prophylactic     preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be     within standard-of-care.      This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics     to determine if the use of preoperative prophylactic antibiotics decreases the postoperative     risk of localized urinary tract infection (UTI) and/or systemic infection that started in the     urinary tract (sepsis or urosepsis).   "
68881|NCT02384187|"     The frequent incidence of postoperative vomiting and severe pain in children undergoing     adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration.     Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of     patients, with a reported incidence ranging from 23% to 73%.      There is growing evidence that the perioperative administration of gabapentinin in adults is     beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative     nausea and vomiting, and delirium.      Only few studies in literature explored the analgesic effects of preoperative gabapentin as     premedication in pediatric population. However, the antiemetic effect of gabapentin in     pediatric patients was not systematically investigated before.   "
68882|NCT02384174|"     The development of preventative nutritional strategies to promote healthy ageing is becoming     increasingly important. Elevated thresholds for taste and smell, coupled with swallowing     difficulties and masticatory dysfunction, often result in nutritionally imbalanced diets     among the elderly. This can induce great changes in the composition and metabolic activities     of the gut microbiome, leading to decreased intestinal motility and impaired bowel function.     This can result in constipation or diarrhoea, increased basal levels of inflammation,     immunosenescence and morbidity. The objectives of this study are to use dietary modification     to improve gut health in older people. Diets high in resistant starch or dietary fibre will     be given to 50 elderly volunteers (70-95 years) living in the community, in a randomised     double-blind cross-over study. The aim is to investigate the effects on microbiome     composition and functionality through fermentation, reduced putrefaction, and modification of     blood markers associated with obesity and diabetes.   "
68980|NCT02382887|"     Patients who present with an unstable cervical spine following an accident need a general     anesthesia for the necessary surgery.      Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.      However, changes in equipment availability and quality may challenge the fiberoptic     intubation technique.      The investigators wish to compare the tracheal intubations performed with the Airtraq in     comparison with the fiberscopic technique.   "
68883|NCT02384161|"     Isometric handgrip exercises are used to explain the effects of fatigue on the strength and     activation of the muscles involved. Blood flow available at the time of exercise can     influence this fatigue process, as some studies demonstrate changes in the pattern of muscle     recruitment and strength recovery when the exercise is performed in combination with an     external total obstruction (through a pressure cuff or tourniquet ) blood flow. Low intensity     exercises associated with external partial obstruction of blood flow has been widely used and     studied, mainly due to its effect on increasing strength and muscle hypertrophy, often     comparable to those observed in conventional exercises (ie, without external obstruction of     blood flow) High intensity. Despite the vast literature on this method, some topics need to     be better informed about the underlying neuromuscular physiology to such effects (strength     and hypertrophy) and the process of fatigue during isometric exercises associated with     partial obstruction of blood flow. The aim of this study is to evaluate the acute effects on     neuromuscular response in healthy adults undergoing an intermittent isometric exercise     protocol with different levels of external compression. In a study of the crossover male     volunteers will be submitted to three intermittent isometric exercise protocols (with a load     of 45% of maximum voluntary isometric strength) associated with three different levels of     obstruction (held by a pressure cuff) blood flow (total obstruction, partial obstruction and     free blood flow). The protocols will be performed on three different days (with a minimum of     48 hours between them). Will be considered as acute neuromuscular responses spending time to     failure in the task, the electromyographic activity of the flexor muscles of the wrist and     fingers, and the recovery curve of maximum voluntary isometric strength after exercise. The     main hypothesis of this study is that exercise is performed when associated with partial     obstruction of blood flow, the time spent until the failed job is similar to that seen when     exercise is performed with free blood flow, and the recovery of strength and     electromyographic activity will be similar to that observed in the exercise associated with     total obstruction of blood flow.   "
68884|NCT02384148|"     The investigators aimed to characterize human circadian clockwork in healthy individuals in     comparison to obese and type 2 diabetic subjects, employing the noninvasive experimental     approach allowing the study of circadian profile in human individuals.   "
68885|NCT02384135|"     Prospective validation of an age-adjusted D-dimer cut-off to rule out deep vein thrombosis     (DVT)   "
68886|NCT02384122|"     The purpose of this study is to determine whether long-acting octreotide is effective in the     treatment of patients with refractory anaemia due to angiodysplasias.      The hypothesis is that long-acting octreotide is effective in decreasing the blood and iron     infusion requirements in those patients.   "
68887|NCT02384109|"     This proposed project will translate evidence-based strategies for diabetes prevention within     the framework of an existing and highly utilized pharmacist-led diabetes care program. Our     team includes investigators and practitioners with experience in implementing the DPP     (Diabetes Prevention Program) as well as in community-based research. This proposal     represents an opportunity to rapidly implement an innovative project addressing a critical     area of significant unmet need, as the required key health system and community     infrastructure are already in place. The intended outcome is the creation of a practical,     effective and sustainable approach to increase evidence-based diabetes prevention strategies     that can readily be adopted in other systems.   "
68888|NCT02384096|"     The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with     a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming     features and lead options.   "
68889|NCT02384083|"     Phase I/II, Multicenter, Open Label, Clinical Trial to evaluate safety and efficacy and     determine the Maximum Tolerated Dose (MTD) of Filanesib in combination with pomalidomide and     dexamethasone in relapsed/refractory (R/R) Multiple Myeloma (MM) patients   "
68890|NCT02384070|"     Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR     calculation, no study has evaluated the optimal anti-thrombotic regimen in patients     undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy     for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a     simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with     aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in     patients with intermediate coronary artery stenosis undergoing FFR calculation during     elective coronary angiography.   "
68891|NCT02384057|"     C8 sciences program is a cognitive training program mainly developed for the students, and     the effectiveness is well established. The aim of this trial is to assess clinical efficacy     of the program for cognitive rehabilitation of the patients with stroke or brain injury.   "
68892|NCT02384044|"     This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip     on existing dentinal hypersensitivity compared to a marketed sensitivity pen.   "
68893|NCT02384031|"     Post-dural puncture headache (PDPH) is the most common complication following lumbar puncture     (LP). The frequency varies widely depending on a number of factors, among which patient     characteristics, case ascertainment, gauge and type of needle used are of significant     importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who were subjected     to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle suffered post-dural     puncture headache, while over 24 % of 115 who were given a lumbar puncture with a 22 gg     traumatic needle suffered a headache. This finding provided the basis for an American     recommendation to use a 22 gg atraumatic needle for diagnostic lumbar puncture. A later study     with 58 patients has shown an even greater difference (36 % versus 3 % post-dural puncture     headache) when an atraumatic needle is used. Despite these findings, European Neurologist     continue to hold on to the cutting needle. Here the investigators propose a prospective     randomized study design with double masking; neither patient nor evaluator of PDPH aware of     the needle design used, and with an active ascertainment of the occurrence of PDPH in     accordance with updated headache classification guidelines. The investigators also intend to     investigate whether specific neuroinflammatory substances and metabolites (different outcome     variables) in the cerebrospinal fluid (CSF) will affect the explanatory variable.   "
68894|NCT02384018|"     The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells     (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human     component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently,     the investigators intend to test whether infusion of MSCs immediately after islet autograft     can reduce onset of diabetes and improve glycemic control after total pancreatectomy and     islet autotransplantation.   "
68895|NCT02384005|"     There is no standard screening protocol for anal cancer even as disease incidence increases.     This single-visit study will clarify if single persons can do a self-digital anal exam, or     perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for     reasons of safety, accuracy, or acceptability.      The investigators hypothesize that men having sex with men's digital anal exam (DAE) findings     will have moderate or substantial agreement with a nurse practitioner DAE for detecting an     anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a     secondary hypothesis the investigator believe a partner-assisted DAE conducted within a     couple will have better agreement with the nurse practitioner DAE than will a self-DAE     conducted by a single person.   "
68897|NCT02383979|"     Mirror therapy will consist of observing the unaffected limb reflected in a mirror positioned     in the midline to block the view of the affected limb. All therapy sessions will be     supervised by a physical therapist with the exception of weekends when the patients will     continue therapy on an independent basis. In an effort to objectively demonstrate cortical     reorganization associated with mirror therapy, patients can elect to participate in a     functional MRI (fMRI) portion of the study. The fMRI would be evaluated prior to initiating     the experimental or control therapy (Due to the sensitive timeline in this population and its     effect on recruitment, we have amended the protocol to allow recruitment and enrollment to     take place even if the timeline does not allow for the fMRI to be executed 2 weeks prior to     amputation. Though this would be ideal, we will accept subjects that are only available for     day before amputation scans), just before the operative procedure, at four weeks     post-operation and then again at one year. All subjects will be evaluated at 4 weeks, 8 weeks     (functional physical therapy (PT) tests only) 12 weeks, and 12 months postoperatively to     determine 1) the incidence, severity and functional impact of phantom limb pain 2)the ability     to meet various specialists' endpoints, to include participation in physical therapy, and 3)     overall quality of life which the patients can describe subjectively. This therapy could have     a dramatic impact on the long term prognosis of amputees whether due to trauma, metabolic     conditions, tumor, or peripheral vascular disease.      This protocol will include performing fMRIs on a cohort of healthy, active duty, age matched,     male personnel to create reference data to compare the fMRI data of study participants.   "
68898|NCT02383966|"     This trial aims to assess efficacy and safety of cetuximab when given in combination with     chemotherapy compared with chemotherapy alone in Chinese subjects with recurrent and/or     metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.   "
68899|NCT02383953|"     This study aims to investigate the role of non-genetic factors in the pathogenesis of     inflammatory bowel disease.An exploratory study to investigate differences between the     epigenome, microbiota and functional immunology in twins discordant for inflammatory bowel     disease.   "
68900|NCT02383940|"     This Phase 2 study is intended to demonstrate superiority of Sotagliflozin versus placebo on     A1C reduction at Week 12 in young adult patients with T1DM who have poor glycemic control on     their current insulin regimen.   "
68901|NCT02383927|"     Phase II study to investigate the antitumor activity in terms of ORR of tipifarnib in     subjects with advanced tumors that carry HRAS mutations and for whom there is no standard     curative therapy available.   "
68902|NCT02383914|"     The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as     the circumstances require to found a new classification.      The prime objective is a comparison of the conclusive of the clinic check-up, the sonographic     and magnetic resonance tomography findings.      The secondary objective is to detect the correlation of the outcome with the age , the     gender, the pathogenesis and attendant injuries.   "
68903|NCT02383901|"     The purpose of this study is to investigate to which extend osteosarcoma patients do NOT meet     the criteria for successfully advancement to next planned chemotherapy course.   "
68904|NCT02383888|"     To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy     Chinese and Japanese male subjects following the administration of single rising oral doses     and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809     after single dosing of product.   "
68905|NCT02383875|"     The Opticourses project aims to improve the nutritional quality/price (NQP) ratio of the food     purchases of people claiming to be facing financial problems. Following one of the main     principles of the French National Nutrition and Health Program (PNNS), the project starts     from the principle that to modify food consumption favourably and durably, one must act on     both the demand and the supply (see figure). The demand part of the project is based on     participatory workshops, and the supply part relies on intervention of social marketing in     shops.   "
68906|NCT02383862|"     The purpose of this study is to determine the effectiveness of providing PROMIS Profile Scale     scores (e.g., sleep, pain, anxiety, depression, energy/fatigue) to physicians on patients'     symptoms.   "
68907|NCT02383849|"     P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are     receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis,     tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment     containing lopinavir/ritonavir (LPV/r). The study is designed to describe the     pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the     drug(s) as part of clinical care.   "
68908|NCT02383836|"     Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD)     performed and a comparison of timing, sensitivity and intensity of intravenously injected     bubbles will be determined.   "
68909|NCT02383823|"     The study examines the effect of hormone replacement in postmenopausal women compared to men,     55 years of age, and in the elderly without hormone replacement of both sexes. The lipid and     glucose metabolism is evaluated during treatment and placebo with a meal with mashed potatoes     and different types of fat. Glucose, insulin, triglyceride, total cholesterol, LDL and HDL     cholesterol, free fatty acids and coagulation parameters are measured.      During menopause the women reduce their levels of estrogen and their risk of cardiovascular     disease rises to the men's level. This effect on mortality and morbidity can probably be     reduced by hormone therapy.   "
68910|NCT02383810|"     This is a randomized, stratified, double-blind, double-dummy, parallel group,     placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with     colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI).     Patients will receive, starting from the day of chemotherapy administration, a single daily     dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days.     Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment period     for each patient will be 4 consecutive days at each of the first 2 chemotherapy cycles.      The primary objective is to compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.)     placebo and vs. each other dose in the prevention of CID in colorectal cancer patients     treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal     antibody.   "
68911|NCT02383797|"     The investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to     varicella (VZV) and immunize patients in a controlled manner with VZV vaccine. Patients will     be selected on the basis of disease severity and the degree of immunodeficiency (including     CD4+ T-cell counts). Any potential complication of VZV immunization, such as rash, will be     discussed with the patients/caregivers beforehand and acyclovir will be used to treat any VZV     related symptoms, consistent with the current practices. The investigators will verify the     development of immune response to vaccination by testing for VZV antibodies and cell-mediated     immunity.   "
68912|NCT02383784|"     Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on     inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged     42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI     (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30     consecutive days. The other meals were consumed under free living condition and subjects were     instructed to select foods presenting GI values corresponding to the allocated group. Body     composition (body mass index, body fat percentage, waist circumference and waist-hip ratio),     and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high     molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and     metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids,     triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake     was monitored during the study. The criterion for statistical significance was P<0.05.   "
68913|NCT02383771|"     The purpose of this study is to determine the proportion of untreated donor platelets     required to fully reverse the platelet inhibitory effects of ticagrelor and aspirin in     healthy persons and patients with coronary artery disease undergoing percutaneous coronary     intervention (PCI) and receiving ticagrelor.   "
68914|NCT02383758|"     The purpose of this study is to try to treat bowel movement (BM) accidents differently with     children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC)     medications to evoke predictable bowel movements. This will make it possible for     investigators to use certain strategies to reward BMs in the toilet. Independence will be     increased by fading out the use of medications. The investigators will also train caregivers     to implement the procedures.   "
68915|NCT02383745|"     In Kuopio University Department of Clinical Neurophysiology there have been designed a fast     EEG electrode, that is suitable for acute emergency use. It is easy to set up, records high     quality EEG and can detect the most important EEG abnormalities comparable to conventional     EEG. This study will address the clinical use of acute EEG with fast electrode set in     in-hospital patients who have been consulted by Medical Emergency Team because of seizure or     altered mental state of uncertain etiology. Patients are going to be treated in ICU and EEG     monitoring will continue for 24 hours.   "
68916|NCT02383732|"     The purpose of this study is to demonstrate the feasibility of the Elopement Prevention     Safety (EPST) program in children with autism spectrum disorder (ASD) who have engaged in     eloping. This is a program created by the Behavior Treatment Clinics to help caregivers come     up with a safety plan to prevent their children from running away or wandering off.   "
68917|NCT02383719|"     Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive     ventilation (non-intubated) with a feasibility study.   "
68918|NCT02383706|"     Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current     screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim     of this study is to develop a valid screening tool to identify at-risk pregnant women, so     that they can be further evaluated and treated. Women with OSA may also be at risk for     respiratory complications related to opiate administration for post-cesarean delivery pain. A     secondary aim of this study is to evaluate post-operative minute ventilation in women who     undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.   "
68919|NCT02383693|"     number of center : 1        -  duration of study : 24 months        -  recruitement time : 23 months        -  Aim :Principal      Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled     study for TRD patients.      Secondary      Evaluate the impact of rTMS on cognitive functions.   "
68920|NCT02383680|"     Travelers (n = 30, 15 taking low-dose methotrexate (MTX), 15 healthy controls (HC), seeking     travel advice in one of the following Swiss Travel Centers (Aarau, Basel, Bern, Geneva,     Lausanne, Zurich) and who have an indication for yellow fever (YF) vaccination according to     the Swiss Federal Office of Public Health's vaccination recommendations are invited to     participate in this study. After signing the consent form (i) YF viremia and (ii) anti-YF     antibody production in patients taking low-dose MTX and HC will be compared after YF     vaccination. It will be analyzed whether the percentage of people with protective antibodies     differs between the two groups and (iii) vaccine side effects will be compared between the     groups.   "
68921|NCT02383667|"     The objective of the study is to compare electrocardiograms using ambulatory holter monitor     with dry electrodes in a harness versus using an ambulatory holter with standard sticky     electrodes (Red Dot) on monitored patients within the hospital. Patients will be     simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be     not less than one hour. One holter will use standard electrodes in a standard electrode     distribution. The second holter will use dry electrodes in a derived.   "
68922|NCT02383654|"     The purpose of the study is to determine the safety and possible effectiveness of Autologous     Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.   "
68923|NCT02383641|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman     disease from plasma and saliva. Testing for clinical robustness, specificity and long-term     stability of the biomarker.   "
68924|NCT02383628|"     The main objective of the study is to evaluate the efficacy of indocyanine green (ICG)     endoscopy to evaluate tissue perfusion during endoscopic neurosurgery. This includes patients     with pituitary and intracranial tumors and treatment of vascular abnormalities such as     aneurysms and compressive syndromes. ICG will be evaluated to determine the value of the     additional visual information supplied during the treatment of these pathologies.   "
76425|NCT02285491|"     Local anesthetic will be injected into both angles of the rectus sheath incision in an     attempt to block sensory nerves in this area that cause the sensation of pain from lscs     wound.   "
68926|NCT02383602|"     HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants     Same-day result HIV testing along with pre-test and post-test counseling, including risk     reduction counseling, will be provided according to the standard practice at each study site     at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can     also access non-occupational post-exposure prophylaxis service and symptomatic STD service if     these are available at study sites. HIV-positive participants will also receive risk     reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.   "
68927|NCT02383589|"     This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm,     multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in     participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day)     oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the     previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of     active disease at screening.      Approximately 124 participants will be enrolled at up to 60 centers worldwide. Participants     will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab     placebo plus MMF. Randomization will be stratified by duration of illness.      The study will consist of three periods: a screening period of up to 28 days, a 52-week     double-blind treatment period, and a 48-week safety follow up period that begins at the time     of study treatment completion or discontinuation.   "
68928|NCT02383576|"     This study aims to understand better the effective results from the IMELDA MO22223 P-trial     (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after     study treatments were terminated possibly had an effect on efficacy results.   "
68929|NCT02383563|"     This proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques     and calcified plaques assessed by coronary CT angiography, and on whether these changes can     be explained by metformin-induced phenotypic and secretory changes of monocytes.   "
68930|NCT02383550|"     This study is designed to demonstrate that Tysabri is effective in maintaining cognition in     MS patients after 5 or more years of continuous treatment.      During a second period of 36 months, the extension study will assess the evolution of     cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test     (SDMT) and a CogState battery of tests.   "
68931|NCT02383537|"     The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on     the pathophysiology of diabetes during pregnancy. During the study fat tissue, Umbilical cord     blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over     going a C-section. Healthy pregnant women will serve as a control group.   "
68932|NCT02383524|"     The Investigators have designed this exploratory study in patients suffering from     zygapophysial joint mediated pain to investigate if a correlation exists between     inter-individual genetic variability (genotype) with treatment response (phenotype). More     specifically, the investigators aim to identify any form of correlation between a specific     SNP of the BDNF gene (Val66Met) and the effectiveness and/or duration of radiofrequency facet     joint neurotomy. The study population is patients suffering from chronic low back pain who     have been scheduled for radiofrequency neurotomy following the diagnosis of facet joint     mediated pain (using medial branch block test). The investigators will evaluate if a common     variant of BDNF gene (Val66Met) can be directly correlated to a significant degree of pain     relief following RF treatment, and whether the result of such a procedure can be predicted     from a specific genetic profile.   "
68933|NCT02383511|"     Placebo-controlled, multi-centre, randomized, double-blind dose escalation study. The aim is     to evaluate the pharmacokinetics (PK) and safety of SMT C1100 in paediatric patients with     Duchenne Muscular Dystrophy (DMD) who follow a balanced diet.   "
68934|NCT02383498|"     TRIAL SUMMARY      Researchers at the National Cancer Institute (NCI) are now enrolling patients in a phase 2     clinical trial to determine whether the yeast-brachyury vaccine GI-6301 improves the     effectiveness of radiation for patients with localized chordoma. Chordoma patients with     inoperable or residual tumor who do not have metastases and are planning to be treated with     definitive (>70Gy) radiation are eligible to participate. Patients will initially be     randomized to receive radiation plus the vaccine or radiation plus a blinded placebo. Those     randomized to receive radiation plus placebo will have the option to receive vaccine if their     tumor grows while on the study. The study will compare the outcomes of patients treated with     radiation with and without the vaccine to determine whether the vaccine can increase the     chances of shrinking the tumor and/or preventing further tumor growth.      WHY THIS TRIAL IS BEING DONE      The primary treatment options for chordoma currently consist of surgery and high dose     radiation. Radiation has been shown to improve patient outcomes following surgery. Radiation     is also sometimes used instead of surgery when surgery would carry unacceptable risks.      The chance of tumor growth after radiation is significantly higher for patients who have     residual tumor than for those whose tumor is completely removed. Unfortunately for patients     with a tumor that cannot be completely removed, there tends to be a short time until the     tumor grows back and eventually causes death. For this reason, our team at the NCI seeks to     identify a therapy that can reduce the risk of recurrence and improve survival after     radiation for patients who have residual tumor.      One approach we are pursuing is treating patients with a therapeutic vaccine that is intended     to stimulate the immune system to fight cancer cells that express the brachyury protein.     Brachyury is present at very high levels in nearly all chordomas but is not present in the     vast majority of normal tissues, making it a promising target for immune therapy. Research in     other cancers suggests that radiation in combination with immune therapy can provide powerful     antitumor effects.      We have recently completed a phase 1 clinical trial of a therapeutic vaccine targeting     brachyury called GI-6301 in which 11 chordoma patients participated. Through that phase I     trial, we learned that this vaccine can be given safely without serious adverse reactions. In     that study, the vaccine was also capable of inducing immune responses against brachyury and     one patient had his tumor shrink more than 30% while on study. Some other patients (7 of 10     evaluable) also had stable disease for more than 5 months while on study. However, these     clinical findings are not definitive and further clinical testing is required to determine     the benefit of this vaccine in chordoma. To that end, we have designed a larger phase 2     clinical trial intended to determine if this vaccine, when given in combination with     radiation, improves outcomes for patients with chordoma compared to those who only have     radiation.      WHO CAN PARTICIPATE      We have designed this trial for patients who have residual tumor remaining after surgery, who     are unable to have surgery, or who have a local recurrence following previous treatment.      To be eligible for enrollment on this study, patients must:        -  Have a confirmed diagnosis of chordoma        -  Have only localized tumor (no metastases)        -  Be able to receive at least 70 Gy of radiation to their localized tumor        -  Be willing to travel to Bethesda, MD for treatment and follow-up visits      HOW THE TRIAL WILL WORK      The trial is taking place at the National Institutes of Health Clinical Center in Bethesda,     MD. The NCI will pay for transportation costs (including airfare) and a portion of lodging     costs for patients after enrollment in this study.      The process of participating in the trial is as follows:        -  Patients travel to NIH to receive injections of the vaccine (or placebo) every other          week for three doses prior to starting radiation (approximately 4 weeks)        -  Patients then complete their radiation treatment with their home radiation oncologist          (typically over a 1-2 month timespan)        -  Following completion of radiation treatment plan, patients travel back to NIH to resume          vaccine (or placebo) injections every 2 weeks until 6 total doses have been given (3          doses after radiation, another 4 weeks)        -  At that point, doses spread out to every 4 weeks for 4 doses, and then 1 dose every 3          months until disease progression.        -  Between all doses of vaccine, patients may return home and travel back for the next          visit. There is no requirement to stay locally in Bethesda at any point in the study          outside of clinic visits and dosing days.        -  Repeat imaging studies will be performed about 3 months after completion of radiatio...   "
68935|NCT02383485|"     Nonalcoholic fatty liver disease is a serious health condition in overweight children which     can lead to heart disease. This project will examine the links between liver health and     cardiovascular risk factors in overweight and obese children, and will test the effect of a     long-term after-school exercise program.      Provision of comprehensive evidence for the benefits of exercise on children's health may     reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.   "
68936|NCT02383472|"     A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering     from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with     cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo     therapy (controls) or treatment with LED therapy (cases). Both cases and controls would     complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and     ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms     resolve before the end of the 6 week period.   "
68937|NCT02383459|"     Food habits form early in infancy and are likely to track into childhood until the beginning     of adulthood. Understanding the factors driving the acceptance of foods in the early years is     therefore of particular importance, since these foods will form the basis of a child's future     food repertoire. This is especially important for vegetables, which consumption is     recommended at all stages of life but is below the recommended levels and which acceptance is     difficult to promote during late childhood.      The objective of the present study was to unravel the respective contribution of maternal     feeding practices, of children's rate of exposure to vegetables and of children's sensory     reactivity factors over the course of the first two years, to explain the development of     liking for vegetables at the age of 2 years. This analysis took advantage of data recorded in     a prospective cohort of children recruited before birth and followed up longitudinally until     the age of 2 years.   "
68978|NCT02382913|"     The purpose of this study is to evaluate the persistence of immune response against the three     pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and     anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study     vaccines or Boostrix® during V113_01 study.      There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw     after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood     was withdrawn.      No vaccine was administered and no safety data was collected in this study.   "
68938|NCT02383446|"     Background:      Trauma is the second most common factor for transtibial amputations, just after vascular     background. Traumatic amputees generally function better than amputees due to vascular     background. The type of prosthetic foot fitted to the patient depends on his mobility and     functional level, and significantly influences his stability and gait symmetry. A prosthetic     foot with a hydraulic ankle provides significant advantages for high level functioning     amputees: decrease of loads in the residuum, improvement in symmetry and generally gait     pattern that is closer to natural. The hydraulic prosthetic foot has recently been upgraded     to include computerized control over the ankle movement, using input from an array of sensors     inside the foot. Studies have demonstrated decrease in energy consumption and gait pattern     that is more similar to healthy people. However, hydraulic feet with and without computer     control have not been compared. Furthermore, the effects of a computerized foot on various     important factors have not been investigated yet, e.g. loads in the residuum, the movement of     the center of pressure and the patient's satisfaction.      Research objectives:      To compare between hydraulic prosthetic feet, with and without computerized control. The     comparison will be made while walking on flat or inclined surfaces (positive or negative     inclination). Differences in gait parameters, loads inside the residuum, center of mass     movement and patient's satisfaction will be quantified.      Research hypothesis: Using a computerized prosthetic foot will provide better mobility     performances: improved gait factors and center of pressure movement, decrease internal loads     in the residuum and increase patient's satisfaction.      Research design:      Clinical controlled research with research group(amputees) and control group (healthy).   "
68939|NCT02383433|"     This phase II trial studies how well regorafenib and gemcitabine hydrochloride work as     second-line therapy (treatment given when initial treatment doesn't work) in treating     patients with pancreatic cancer that has spread to other parts of the body. Regorafenib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving regorafenib together with gemcitabine hydrochloride may     kill more tumor cells.   "
68940|NCT02383420|"     The purpose of this clinical study is to evaluate the imaging performance of the Carestream     PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the investigational     devices) as compared to the currently marketed Carestream DRX-1 Detector (referred to as the     predicate device). Both detectors are flat panel digital imaging devices. The results of     this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to     market the new detectors in the US. The study was designed in accordance with the FDA     Guidance titled Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging     Devices, issued on August 6, 1999.   "
68941|NCT02383407|"     The primary aim of the current proposal is to evaluate safety and tolerability, in terms of     neuropsychological effects of low frequency electrical stimulation of the fornix (LFSF) in     participants with medically-intractable Mesial Temporal Lobe Epilepsy. Secondary aims include     evaluation of psychiatric changes, seizure frequency, and quality of life during LFSF.   "
68942|NCT02383394|"     Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy     loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.   "
68943|NCT02383381|"     •Background and study aims : The investigators conducted this study to evaluate the movement     of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT.        -  Who can participate? patients who underwent typical lateral rectus recession surgery for          correcting intermittent exotropia        -  What does the study involve? Volunteers will attend a clinic for four visits over six          months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is          non-invasive test to evaluate operation site. The test only requires their cooperation          when they undergo AS-OCT.        -  What are the possible benefits and risks of participating? This is non-invasive test for          your postoperative follow up. Therefore, there will be no risks about this test.        -  Where is the study run from? Samsung Medical Center        -  When is the study starting and how long is it expected to run for? From Feb 2014 to Dec          2014   "
68944|NCT02383368|"     The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to     determine the maximum tolerated dose and recommended phase 2 dose of ASP4132. The study will     also determine the pharmacokinetics (PK) of ASP4132 and evaluate the preliminary antitumor     activity.   "
68945|NCT02383355|"     Cardiovascular disease (CVD) has emerged as a leading cause of morbidity and mortality in     HIVinfected individuals. The precise mechanisms underlying this increased cardiovascular risk     remain to be elucidated. Platelet hyperreactivity and increased platelet-monocyte aggregation     (PMA) are found in HIVinfectedpatients and may contribute to the excess cardiovascular risk     as platelets play a key role in the onset and progression of atherosclerosis and in acute     cardiovascular events. In addition, HIV-infected individuals frequently suffer from     persistent immune activation and inflammation. In a crosssectional study the investigators     recently showed that individuals using a regimen containing the integrase inhibitor     raltegravir have reduced platelet hyperreactivity and PMA compared to other antiretroviral     regimens. Other recent studies showed that raltegravir is associated with decreased immune     activation. Due to the inherent limitations of cross sectional studies, the investigators aim     to expand our findings in an intervention study. The investigators will conduct a randomized     control trial where the investigators switch patients to a integrase containing treatment     regimen to assay possible changes in platelet function and persistent immune activation.     Knowledge gathered in the proposed study can help understand and prevent cardiovascular     disease in patients treated for a HIV infection by reducing platelet hyperreactivity and     persistent immune activation.   "
68946|NCT02383342|"     Pain is the most frequent cause of suffering and disability in society. Despite considerable     involvement of genetic factors in pain sensation and sensitivity, the individual genes     involved remain largely unidentified.      Knowledge of genetic factors,their phenotypic expression in pain processing, and their link     to neuronal correlates can improve our understanding of pain aetiology and the processes     involved in pain perception and chronification. In addition, they can serve as biomarkers to     predict chronic pain development and progression in individual patients and help early     individual treatment adaptation.   "
68947|NCT02383329|"     The purpose of this study is to test whether the provision of ONS to malnourished children     across Europe, in addition to standard counselling, will improve weight gain and other     outcomes.      The hypothesis to be tested is:      • Supplementation with ONS in malnourished paediatric patients will lead to increased WFH     gain, as well as less malnutrition related complications (e.g. infections).      Primary outcome • The change in BMI z-score over the intervention period of 3 months      Secondary outcomes      • The change in WFH-weight for height (z-scores) over the intervention period of 3 months   "
68948|NCT02383316|"     Noonan syndrome (NS) is a rare genetic disease (incidence 1/2500 live births) characterized     by the association of craniofacial manifestations, cardiopathies, short stature, and tumor     predisposition. The genetic causes of Noonan Syndrome are mutations of genes involved in the     Ras/Mitogen-Activated Protein Kinases (MAPK) pathway, mainly the gene encoding the tyrosine     phosphatase Shp2 (50% of patients).Shp2 appears to be involved in many facets of energy     metabolism control (glucose homeostasis, adipose tissue function…), through mechanisms that     are poorly understood. Several metabolic anomalies (reduced adiposity, improved glucose     tolerance) have been recently identified in an original mouse model carrying Shp2 mutation.     Moreover, recent clinical survey has shown that adult Noonan Syndrome patients are protected     from developping overweight and obesity when compared to the general population. However, the     metabolic status associated with Noonan Syndrome condition has not been explored to date.   "
68949|NCT02383303|"     The U.S. Department of Health and Human Services, Administration for Children and Families     (ACF) is conducting an experimental evaluation of the Assets for Independence (AFI) Program.     This evaluation—the first experimental evaluation of Individual Development Account (IDA)     projects operating under the Assets for Independence Act—will contribute importantly to     understanding the effects of IDA projects and IDA project features on participants. IDA     programs provide matching funds to participants when the savings are withdrawn to spend on     qualified asset purchases, most commonly homeownership, business-related expenses, or     education.      This study will build on the prior quasi-experimental AFI evaluation, as well as studies of     other non-AFI funded Individual Development Account (IDA) projects. While some evaluations     suggest that IDAs help low-income families save, rigorous experimental research is limited.     No experimental evaluation of AFI-funded programs has been conducted to date. Of the quasi-     or non-experimental studies, few have focused on AFI-funded IDAs.      The evaluation is being conducted in two sites, with the random assignment of 299     AFI-eligible cases in one site and 509 cases in the other, for a total of 808 cases. Each     site randomly assigned sample members to one of two groups: a control group and a treatment     group receiving conventional AFI services. The primary research questions the study seeks to     answer are:        1. What are the impacts of AFI program participation on the outcomes it is designed to          address (e.g., savings and asset purchases)?        2. What are the impacts of AFI program participation on other outcome domains that the          program might influence (e.g., material hardship, alternative financial product use,          economic well-being)?        3. How do the impacts of AFI program participation vary over time and by participant          characteristics?      The study uses a two-armed (treatment vs. control) experimental design. This design allows     the first two questions above to be addressed using a rigorous randomized approach.      In addition to the impact study, the evaluation includes an implementation study to describe     and document how the AFI program is designed, implemented and operated in the participating     grantee sites during the time of the study. This information will be used to provide context     for interpreting the findings of the impact study.   "
68950|NCT02383290|"     Certain parts of the gene can predict how an individual person will respond to medication     (pharmacogenetics). We will invite 250 individuals to give a sample of saliva. This sample     will be sent to a laboratory for limited genomic analysis relating to pharmacogenetics. When     personal data held by the participants, family physician, or pharmacist is joined with the     genetic data personalized prescription recommendations are formed. The family     physicians/pharmacists can view these recommendations through their electronic record. This     should result in prescriptions that may be more beneficial and cause fewer adverse events.   "
68951|NCT02383277|"     Investigate the effects of stretching the muscles of the rib cage in individuals with COPD     during exercise.   "
68952|NCT02383264|"     Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a     challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm     infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis     (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence     of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the     establishment of an adequate early enteral nutrition is frequently hampered. Early     identification of preterm infants at high risk for gastrointestinal complications could help     clinical decisions on the introduction and the advancement of enteral feeding.      Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen     saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first     week of life and subsequent NEC development has been reported. To date, however, splanchnic     oxygenation patterns in response to the first bolus feed and possible correlations with     subsequent FI development have not been yet established.      This observational prospective study aims:        -  to assess abdominal rSO2 patterns in response to the first bolus feed;        -  to evaluate possible correlations with subsequent development of gastrointestinal          complications.   "
68953|NCT02383251|"     Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory     ovarian cancer who relapse during bevacizumab maintenance.   "
68954|NCT02383238|"     Dapagliflozin leads to improved vascular function in the micro- and macrocirculation by     action on various cardiovascular risk factors, in particular by effectively controlling     hyperglycemia, arterial hypertension and reducing whole sodium content amongst others.   "
68955|NCT02383225|"     This study involves adaptation, implementation, and rigorous evaluation of a family-based     program designed to prevent early initiation of substance use on a Northern Plains Indian     reservation. The program, Thiwáhe Gluwáš'akapi, is a cultural adaptation of the Iowa     Strengthening Families Program for Parents and Youth 10-14. Youth and their     parents/caregivers will participate in weekly group sessions for 7 weeks and complete pre-     and post-intervention surveys assessing a variety of risk and protective factors and youth     outcomes. The evaluation design will allow the assessment of the effectiveness of different     components within the program.   "
68956|NCT02383212|"     This is a phase 1, open-label, multicenter, ascending-dose escalation study of REGN2810,     alone and in combination with other anti-cancer therapies in patients with advanced     malignancies.   "
68957|NCT02383199|"     The purpose of this study was to report the long-term objective and subjective outcome after     prolapse surgery with polypropylene mesh. The complications and the effect of the learning     curve of the surgeons to the outcome is also reported.   "
68958|NCT02383186|"     The purpose of this study is to determine whether a single layer dermally sutured wound     results in superior outcomes to a layered closure.   "
68981|NCT02382874|"     Idiopathic Focal Segmental Glumero Sclerosis (FSGS) is not very common but important     manifestation of kidney disease.      FSGS has poor prognosis among the patterns of Idiopathic Nephrotic Syndrome (INS).      Even with treatment (Steroid therapy and cytotoxic immunosuppressant therapy), many patients     eventually still require dialysis.      Cell therapy is useful in treatment of INS and mesenchymal stromal/stem cell is one of the     cells that useful in the treatment of glomerulus disease.      Intravenous injection of allogeneic adipose derived mesenchymal stromal/stem cell will be     done in 5 patients with refractory INS(FSGS). They will be followed 1, 2, 4 weeks and then     monthly until a year following injection day.   "
68959|NCT02383173|"     The overarching goal of this research program is to improve the quality of end-of-life care     provided to Veterans dying in VA Medical Centers, by transferring the best practices of home     hospice and palliative care for the last days and hours of life into the inpatient setting.     This trial will examine two methods of delivering a Comfort Care Education Intervention     utilizing the established infrastructure of VA Palliative Care Consult Teams (PCCT): a Basic     Implementation Approach using a teleconference to review educational materials and activate     PCCTs to educate other providers, and an Enhanced Implementation Approach utilizing     in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers     at their home sites. Findings will provide a robust evaluation of the implementation process,     and will be used to refine the Comfort Care Education Intervention and implementation     strategies in preparation for nationwide dissemination of best practices for end-of-life care     within the VA Healthcare System.   "
68960|NCT02383160|"     This is a prospective, double-blind, randomized controlled trial to determine the     effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid     non-unions after operative fixation as measured by serial CT scanning. Multiple centers     within the Calgary zone will be involved in the study in order to recruit enough patients to     power the study. Blinding will include patients, surgeons, research assistants, as well as     all data handlers and analysts until trial completion or mid-term analysis.   "
68961|NCT02383147|"     Chronic tinnitus affects about 10-15% of the population in industrialized countries.     Investigations of the brain activity by using electroencephalography (EEG) showed that in     localized regions of the hearing system brain activity was decreased. This reduction of     activity is thought to be one of the reasons that keep the perception of the tinnitus going.     Recent studies have shown that neurofeedback is a viable option for treatment of chronic     tinnitus. By using neurofeedback it is possible to train brain functions by the simple     principle of rewarding wanted changes and punishing unwanted ones. The purpose of the     investigators study is to show the efficacy of specific localized neurofeedback training in     comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus     symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned.     Before and up to 6 month after the training EEG-recordings are performed.   "
68962|NCT02383134|"     The achievement of peripheral nerve block requires several needle passes, with each of them     being at risk of causing nerve injury either by direct trauma or intraneural injection even     with the use of the ultrasound.      The ultrasound guided supraclavicular brachial plexus block is known to be at risk of     pneumothorax and / or nerve injury.      This study is designed to determine the maximal effective distance away from the nerve for     the injection to be effective.   "
68963|NCT02383121|"     Acute ischemic stroke (AIS) affects over 700,000 Americans every year and is the leading     cause of long-term disability. Early neurological deterioration after AIS typically occurs     within 72 hours of stroke onset and affects 30% of all stroke patients, who have a higher     rate of death or poor outcome. Several mechanisms account for early neurological     deterioration, including hemorrhagic conversion, systemic illness, cerebral edema, and     seizure, but the most common cause is extension of the stroke into the penumbra, a region     of salvageable brain tissue surrounding the core of irreversible ischemic infarct. The     penumbra is tenuously perfused by collateral blood vessels. AIS management is primarily     focused on recanalizing the occluded artery causing the stroke, but an alternative and     relatively unexplored approach is optimization of collateral blood flow.      Over 60% of AIS patients present with a transient acute hypertensive response, which is     theorized to be the result of either increased sympathoadrenal tone, poorly controlled     underlying hypertension, or an unknown stroke-specific mechanism related to augmenting     cerebral perfusion through collateral blood flow. Epidemiological data suggests worse stroke     outcomes are associated with extremes of sustained hypo- or hypertension, which has led to     dozens of clinical trials involving over 20,000 patients to determine if pharmacologically     lowering blood pressure after AIS is beneficial. The results have been persistently neutral     or negative. In contrast, there have been no major clinical trials on the efficacy of using     vasopressor medications to maintain or increase baseline blood pressure after AIS, despite     promising preclinical data and pilot studies that showed no increase in cerebral hemorrhage     or edema. The only randomized trial of vasopressor use after AIS demonstrated an improvement     in clinical outcomes, but there was no difference in mean blood pressure between the control     and intervention arms, suggesting the beneficial effect was not exclusively related to     induced hypertension. One possibility is that the vasopressor reduced blood pressure     variability, which preliminary data has shown to be detrimental after AIS, although that     aspect of neurovascular coupling has not been adequately studied in the acute phase after     AIS.      The reliance on IV vasopressors, which are only administered in the intensive care unit, is a     fundamental limitation of prior research. An alternative, but untested, approach is to use     the oral vasopressor midodrine hydrochloride. We hypothesize that frequent midodrine dosing     after AIS can optimize collateral blood flow and help salvage the ischemic penumbra. The     objective of this study is to develop tools to quantify midodrine's effect on blood pressure     and the ischemic penumbra.   "
68964|NCT02383108|"     A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and     antiviral effect of current standard antiretroviral therapy compared to elvitegravir (EVG)     administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed     paediatric participants.   "
68965|NCT02383095|"     The main purpose of the protocol is to test the efficiency of art-therapy versus     metacognitive rehabilitation on the visual perception disorders observed in patients with     schizophrenia.   "
68966|NCT02383069|"     Asthma is one of the main chronic diseases in childhood and it is characterized by the     inflammation of airways. Individuals with chronic lung disease are more susceptible to     present reduction in exercise tolerance due to pulmonary limitations. The pulmonary     rehabilitation may improve the physical capacity in asthmatic patients, as observed in other     chronic lung diseases.   "
68979|NCT02382900|"     In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital     warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most     common oncogenic high-risk genotypes and cause approximately 70% of all cervical cancers     despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and     penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are     HPV associated. A large number of studies, including both adult and young females, have     demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection     against infection. Immunogenic vaccination results in young men and boys are equally     satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The     recommended vaccination scheme includes three shots giving the second at two months and the     third at six months after the initial shot. Recently, it has been shown that the use of a two     shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is     to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared     with young women and girls.   "
70017|NCT02369341|"     The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals'     Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in     adults (18 to 60 years of age) and in the elderly (over 60 years of age).   "
68967|NCT02383056|"     The goal of the study is to evaluate the effectiveness of the light-emitting diode (LED) in     promoting healing of the wound on lower leg as a result of surgery. Wounds on the lower leg     heal more slowly than wounds on the head and neck; they can also remain deep red for six     months to one year. Doctors usually allow a lower leg surgical wound to heal by itself,     without stitches or other additional treatment. This is because leg wounds do not hold     stitches well and stitches could cause other problems. A major drawback of allowing a     surgical wound on the lower leg to heal by itself is the long healing time that can often     take months. The investigators wish to evaluate if the LED light treatment of the surgical     wound will improve the healing of your wound.      In order to test if leg wounds heal faster after treatment with LED, half of the patients in     the study will receive the LED (Group 2) and half will not receive treatment with LED but     will receive a sham light treatment (Group 1). Essentially, a sham light treatment refers     to regular light (not LED) exposure for 20 minutes. The sham light comes from the same device     as the treatment light (Omnilux machine) however, this light has no anticipated effects on     wound healing and is used simply to reduce the amount of bias that sometimes complicates the     results of these studies. There is no added risk or benefit for the patients in the control     group exposed to the sham light. Both groups will receive the standard care of wounds on the     lower extremity.   "
68968|NCT02383043|"     Cocaine-use disorders continue to be a significant public health concern, yet no effective     medications have been identified. The goal of this study is to establish a research platform     for the development of medications for treatment of cocaine abuse and dependence. This study     will incorporate choice self-administration procedures between drug and a non-drug     alternative reinforcer presented during maintenance on d-amphetamine, which has been     previously shown to reduce cocaine use.   "
68969|NCT02383030|"     Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of     all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some     patients will present metastatic recurrence.      Treatment of breast cancer is determined by the extent of the disease. Early or localized     breast cancer is treated by a combination of surgery and radiotherapy. Adjuvant systemic     therapy, consisting of chemotherapy and/or endocrine therapy, in tumors deemed hormone     responsive, can prolong the disease-free interval and improve overall survival. However,     approximately 30% to 40% of patients with early breast cancer will ultimately relapse, with     either local recurrence or distant metastases, and require further systemic treatment for     advanced disease.      Since breast cancer that recurs or progresses after initial treatment is considered     incurable, the therapy options available for advanced disease are concerned with disease     control and palliation of symptoms.      Hormonal therapy has become the treatment of choice in postmenopausal women with hormone     sensitive breast cancer. Even though the treatment of advanced breast cancer in     postmenopausal women has improved with the introduction of agents such as aromatase     inhibitors, these agents still have limitations, and disease management continues to be     sub-optimal. The use of systemic therapies such as hormonal therapy, chemotherapy or new     biological treatment is to reduce tumour masses, improve survival and preserve quality of     life. Whatever the initial efficacy of the treatment undertaken in metastatic setting, almost     every patient will relapse. The main goal is to improve progression free survival (PFS). To     achieve this, the type of chemotherapy, the optimal duration of chemotherapy, the benefit of     maintenance chemotherapy, the benefit of maintenance hormonal treatment are debatable.   "
68970|NCT02383017|"     This study will examine how the supplement Shroom Tech Sport (STS) affects body composition     and different performance and health measures over the course of 12 weeks. The supplement     will be combined with a concurrent training regime consisting of resistance and high     intensity interval training. Subjects will be tested for percent body fat to determine body     composition. Further, they will also be tested for maximal strength (squat and bench),     maximal power output and fatigue, lactate threshold and maximal oxygen volume consumption     (VO2max). And finally, subjects will be tested for health and hormone markers in the blood.     All of these measures will be compared against a placebo group participating in the same     exercise intervention.   "
68971|NCT02383004|"     Myringotomy tube placement is one of the most commonly performed operations in children.     Emergence delirium after such procedures is common. During emergence delirium children can     become both a danger to themselves and others around them, including family members and     hospital staff.      The primary objective of this study is to determine if acupuncture, when used in combination     with standard anesthetic management, decreases the incidence of emergence delirium in     pediatric patients following myringotomy tube placement. Patients with and without     premedication of midazolam will be included. A secondary objective of this study is to     determine our institution's actual incidence of emergence delirium for this operation using a     validated scale, the Pediatric Anesthesia Emergence Delirium (PAED) scale. We will also     compare rates of emergence delirium in patients that received a premedication of midazolam     versus (V) those that did not (NV).      This is a randomized double-blinded trial. We will enroll 100 children aged 1-6 years old.     Premedication with midazolam will be decided by the anesthesiologist. If needed, the patient     will receive a standard does of oral midazolam plus acetaminophen (V). If the patient does     not require premedication with midazolam, oral acetaminophen will be given alone (NV).      Patients will then be randomized to receive either acupuncture with standard general     anesthesia care (A) or to receive standard anesthetic care alone (S). Patients, their family     members and recovery registered nurses (RNs) will not know if acupuncture was performed.     Intraoperative anesthetic techniques will be standardized and include inhaled inductions with     nitrous oxide and sevoflurane. Anesthesia maintenance will be inhaled sevoflurane and the     usual pain medication ketorolac will be given intramuscularly prior to emergence. Acupuncture     needles will be placed after anesthesia induction and removed prior to leaving the operating     room. A total of 4 needles will be placed, one in each wrist at the Heart 7 (HT7) point and     one in each ear at the Shen Men point. The needles will be inserted bilaterally to a depth of     1.8 mm.      In the PACU, a blinded study observer will evaluate the patient at four time points using the     PAED scale: time of awakening and 5, 10 & 15 minutes after awakening. Follow up phone calls     will be made one day and one week after surgery. Families will be asked about behavior after     discharge, sleep and bed-wetting.   "
68972|NCT02382991|"     Moderately active amputees may have lost their limb due to diabetes, vascular conditions,     trauma, tumour or congenital causes. These amputees currently cannot benefit from having a     computerised knee because of the performance criteria associated with being given one.     However, these amputees have a very high risk of falling because they use a non     microprocessor controlled knee joint (NMPK) and because their physical ability, associated     disability and persistent contralateral leg weakness do not allow them to compensate for a     balance deficit. These amputees restrict how much they move around and their participation     because of their instability and elevated risk of falling.      The objective of the study is to evaluate the effect of the 3C60 knee, a     microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the     risk of falling after three months in moderately active persons with leg amputation above     knee or knee disarticulation.   "
68973|NCT02382978|"     This study will test whether or not nurses can provide well child care in a     multi-disciplinary primary health care team without physicians also seeing the children at     pre-scheduled well child care visits.   "
68974|NCT02382965|"     It is the purpose of this proposal to apply tFUS to the ventral posterior lateral (VPL)     nucleus of the thalamus in humans.   "
68975|NCT02382952|"     The primary purpose of this study is to evaluate the quality of blunt dissection during     abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels     and neurovascular structures while preserving the integrity of these structures.   "
68982|NCT02382861|"     The NAVA, by its more physiological aspect and a better adaptation of the patient to the     ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration     of weaning and so decrease the duration of invasive mechanical ventilation and the     morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory     assist versus the usual management of weaning from mechanical ventilation, in term of     duration of weaning, at the patients in period of difficult weaning from the invasive     mechanical ventilation.   "
68983|NCT02382848|"     This research is being done to find out how effective Prazosin is in the treatment of bulimic     patients experiencing distressing nightmares using subjective and objective measures.   "
68984|NCT02382835|"     This study aims to determine whether subjects who underwent large-diameter metal-on-metal hip     arthroplasty are more likely to have developed heart failure or other conditions as compared     to subjects with conventional hip replacements.      We plan to link the National Joint Registry for England, Wales and Northern Ireland to the     National Heart Failure Audit and GP records.   "
68985|NCT02382822|"     Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy     remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular,     pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors     probably contribute to this pattern. At present, most evidence regarding co-morbidity in HIV     infection rely on cross-study comparisons of HIV-infected persons with published population     rates and few prospective studies in U.S. cohorts. Using well characterized participants from     the Copenhagen General Population Study (CGPS) as controls, we aim to include >1500     HIV-infected persons in the COCOMO study to determine if co-morbidity is more prevalent or     develops at a higher rate in HIV-infected persons. The study will asses 1) cardiovascular, 2)     pulmonary and 3) liver-related co-morbidity using uniformly collected data in the two     cohorts. The investigators aim to study the relative impact of HIV-unrelated and HIV-related     factors on development of co-morbidity.   "
68986|NCT02382809|"     The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine     mouthwash in the prevention of alveolar osteitis following third molar extraction and to     evaluate the safety and local tolerability.   "
68987|NCT02382796|"     The purpose of this study to permit continued access to dacomitinib for patients who     participated in other dacomitinib monotherapy treatment protocols in Japan and have the     potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib     treatment.   "
68988|NCT02382783|"     The purpose of this study is to determine how best to monitor for flares in patients with     rheumatoid arthritis (RA).   "
68989|NCT02382770|"     To evaluate the different indications to Open Abdomen, the different techniques used to     perform it, it's management, it's definitive closure and mortality rates linked to the     different variables. Moreover to evaluate the 1 month and 1 year follow up in patients     underwent to Open Abdomen.   "
68990|NCT02382757|"     This study is conducted in Asia. The primary objective of the CDiC programme is to improve     access to comprehensive diabetes care among the children with diabetes from the economically     underprivileged section of the population and to establish a registry for this group of     children with type 1 diabetes in India.   "
68991|NCT02382744|"     Patients undergoing foot and ankle surgery have the option of having a nerve block     administered by their Anesthesiologist. The nerve block numbs the foot and results in less     post-operative nausea and vomiting, and better pain control. Two different techniques for     blocking the saphenous nerve to the foot have been described and are both commonly used at     St. Paul's hospital. The goal of this study is to compare the success rates of these two     techniques.   "
68992|NCT02382731|"     Proven treatments exist that improve quality of life and reduce the risk of repeat heart     attacks or death amongst persons who have already had one heart attack. These treatments     include medications and supervised cardiac rehabilitation programs. Unfortunately, research     shows that many people who have had a heart attack do not stick with these treatments and     therefore cannot benefit. This quality improvement research program seeks to understand the     impact of interventions that could be readily implemented at scale by entire health systems     or organizations wishing to improve adherence to proven treatments. Specifically, the trial     will test whether providing Ontario-based patients (and their health professionals) with     repeated educational reminders delivered via post and phone will help improve the use of     medications or attendance at cardiac rehabilitation. During the project, the types of     patients who are most responsive will be identified as will the most cost-effective strategy     for delivering reminders. The trial team are partnering in this project with health system     decision makers who have an interest in using the results to create standard operating     procedures that could benefit patients across the province.   "
68993|NCT02382718|"     This is a phase IIb clinical trial to investigate the efficacy and safety of subcutaneous     immunotherapy with a modified parvalbumin called mCyp c 1 for the treatment of fish allergy     to subjects allergic to fish.   "
68994|NCT02382705|"     Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common     indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease     like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.      While CE has high diagnostic value for small bowel lesions, a significant limitation of this     technology is the finite battery life which results in incomplete examination of the small     bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g.     prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer,     chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed     results. Currently routine use of prokinetics (agents that speeds up gut motility) is not     recommended.      This study aims to determine whether longer battery of the newer generation capsule endoscopy     system improves study completion rate and diagnostic yield.   "
68995|NCT02382692|"     Sinus surgery is a common procedure. A potential complication is injuring the membranes of     the brain. This can lead to leakage of brain fluid through the nose. We would like to     estimate the incident rates of that complication. At the end of the operation, a thin gauze     is inserted into the nose on both sides in addition to the usual tampon. This gauze will be     analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.   "
68998|NCT02382653|"     100 patients with Breakthrough pain will be allocated to receive either oral prioxicam (OP)     (n=50) or sublingual fentanyl (SLF) (n=50) . Patients will be divided randomly into two equal     groups: oral prioxicam (OP) Group and sublingual fentanyl citrate (SLF) Group, comprising of     50 patients each.      Pain intensity level on a 0-10 visual analog scale (VAS), patients will be instructed about     the use of a 10-cm visual analog scale (VAS) (0 = no pain to 10 = worst possible pain).     frequency of Breakthrough pain throughout the day, onset of relief (0-5, 6-10, 11-15, or over     16 min), time required for dose titration, patient satisfaction and adverse effects were     assessed at 3, 7, 15, and 30 days after starting the treatment.   "
68999|NCT02382640|"     The purpose of this study is to assess the effect of antacid administration, and its timing,     on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.   "
69000|NCT02382627|"     This study plans to learn more about the thickness of the choroid in patients with optic     neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to     the outer layers of the retina. Patients are being asked to be in this research study because     they have optic neuropathy and are receiving care at the University of Colorado Hospital.   "
69001|NCT02382614|"     VAST is a multicenter, prospective, randomized, controlled study designed to evaluate     treatment of persistent air leak with the SVS as compared to standard chest tube drainage     management and other standard-of-care interventions in the control group. Eligible subjects     will be randomized to receive either Spiration Valves (investigational arm) or continue     standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves     should be removed.   "
69003|NCT02382588|"     The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the     treatment of herpes zoster keratitis. Half the patients will receive the study drug while the     other half of the patients will receive the placebo   "
69004|NCT02382575|"     The vast majority of children with idiopathic nephrotic syndrome respond well to     corticosteroid treatment. However, as many as 20% experience a more complicated course with     steroid resistance (SRNS). Repeated and prolonged courses of steroids in these children often     result in long-term complications. The goal of treatment is to reduce the rate of relapses,     the cumulative dose of corticosteroids, and the incidence of serious complications. In order     to minimize the side effects of steroid therapy, different steroid sparing agents such as     cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF)     have been used in SRNS. Whereas CNI are usually considered the steroid sparing drug class of     first choice, rituximab is increasingly used as alternative to minimize CNI toxicity. Various     prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be     a safe and effective alternative to steroid or immunosuppressants to achieve and maintain     remission in this population. Rituximab infusion have been shown to be efficacious for 6 to     12 months and the side effect profile observed to date is very benign. Studies comparing the     usefulness of these agents are lacking. In this proposed randomized controlled trial, the     investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating     children with SRNS.   "
69005|NCT02382562|"     Depression and other unhealthy behaviors, such as not taking medication as prescribed and not     attending doctor visits have been suggested to increase the worsening of allergic diseases     (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral     intervention is effective in helping with depression and controlling disease symptoms. We     will measure this using pre- and post-intervention surveys.   "
69006|NCT02382549|"     This study evaluates whether it is safe to administer a helper peptide vaccine with     dabrafenib and trametinib. This study will also evaluate the effects of the combination of     the peptide vaccine and dabrafenib and trametinib on the immune system. We will monitor these     effects by performing tests in the laboratory on participants' blood, a lymph node, and tumor     samples.   "
69007|NCT02382536|"     The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid     going through the tubing) and leakage (observation of fluid on and around the device) during     and after subcutaneous infusion using two types of infusion sets. One infusion set is     investigational, developed by BD, and the other is the Quick-set (Medtronic), which is     commercially available. These infusion sets will be used with a commercially available     insulin pump to deliver insulin diluent (an inactive liquid with no medication) for     approximately 4 1/2 hours. During this time pressure and leakage will be continuously     monitored.   "
69008|NCT02382523|"     IgA nephropathy occurs when IgA—a protein that helps the body fight infections—settles in the     kidneys. IgA deposits may cause the kidneys to leak blood and sometimes protein in the urine.     Proteinuria (abnormal amounts of protein in urine) can be a sign of kidney damage. Current     treatments for IgA nephropathy is limited to Angiotensin Converting Enzyme (ACE) inhibitor     medications with fish oil. ACE Inhibitors, also called ACEI medications, slows the     angiotensin converting enzyme so that blood vessels can be relaxed.      This study involves the study drugs, Acthar and Lisinopril (an ACEI medication routinely     given for high blood pressure).      In previous clinical studies, some subjects with IgA nephropathy have experienced reductions     in proteinuria with consistent use of Acthar. Acthar is approved by the Food and Drug     Administration (FDA) and used to treat patients with proteinuria.      The purpose is to study the safety and effectiveness of the study drug Acthar given at     different doses.   "
69009|NCT02382510|"     This multiple ascending dose study is to determine the safety and bronchodilator activity of     TRN-157 in 59 mild and moderate asthmatics.   "
69317|NCT02378467|"     The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice     daily for 48 weeks improves the lung clearance index by multiple breath nitrogen washout in     comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 5)     with cystic fibrosis.   "
69021|NCT02382354|"     Structural differences of supraglottic airway devices could influence the different     compressive forces in the oropharyngeal cavities, and require different depth of anesthesia.     The addition of remifentanil during propofol anesthesia facilitates the insertion of     laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was     designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50)     and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA     insertion during propofol target-controlled infusion (TCI).   "
69010|NCT02382497|"     The present study grounds on the possible role of hemispheric lateralization in Eating     disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa     (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food     craving behaviors.      Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal     cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric     balance in AN patients, re-establish control over eating behaviors. On the contrary, active     excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting     inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing     cravings/appetite binge eating behaviors.   "
69011|NCT02382484|"     The purpose of this study is to test whether the A-V sequential pacing strategy shown to     effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure     acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg) despite     medical treatments.   "
69012|NCT02382471|"     The aim of this study is the comparison between the effects of supplementation with omega 3     or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with     cardiovascular disease.   "
69013|NCT02382458|"     Diet plays a central role in the regulation of chronic inflammation. However, until the     investigators developed the dietary inflammatory index (DII) there had been no scientifically     valid way to relate what individuals eat to the capacity of foods consumed to modulate     inflammation. The DII provides a tool that will form the basis of a counseling/instructional     system aimed at helping patients and their providers to control chronic, systemic     inflammation by improving the diet with specific, actionable dietary recommendations,     counseling, and expert instruction. The goal of this study is to test the applicability of a     DII mobile tool and associated counseling measures in clinical practice.   "
69014|NCT02382445|"     Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent     cognitive deficits with or without evoking postoperative delirium. In animal trials various     anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular     substance of pathophysiologic brain tissues of demented patients. The amount of those markers     seems to correlate well with the degree of dementia [1]. In contradiction, a single study     indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic     depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load,     since this would have clarified if the amount of anesthetics used is associated to POCD and     dementia. Another possibility is that stress and noxious stimulation induced by light     anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit     memory.      The investigators' prospective randomized trial is underway to verify the impact of     anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative     cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90     day period.      The investigators' hypothesis is that the incidence of POCD and delirium and the degree of     early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the     BIS- guided anesthesia group with the superficial but sufficient anesthesia level.   "
69015|NCT02382432|"     This study evaluated the effect of dexmedetomidine iv in three different doses in the     treatment of shivering in patients undergoing minor elective abdominal surgery under spinal     anesthesia, in comparison with intravenous pethidine.   "
69016|NCT02382419|"     This randomized phase II trial studies how well carrageenan-containing gel (vaginal gel)     works in reducing the rate of human papilloma virus (HPV) infection in healthy participants.     Carrageenans, which are naturally derived from seaweed, are enhancements to natural     lubrication and may be effective in blocking HPV infection.   "
69017|NCT02382406|"     This is a phase I/II study for previously untreated subjects with advanced NSCLC. The study     will take place in two phases. First, a cohort of twelve participants will be enrolled in     phase I part and will be treated with carboplatin, nab-paclitaxel and pembrolizumab. A cohort     of twelve subjects will be evaluated for safety and tolerability after 2 cycles of therapy.     All subjects who receive either nab-paclitaxel or pembrolizumab will be evaluable. If 33% of     subjects or less have unacceptable toxicity in the first cohort or any subsequent cohort (if     necessary), the study will proceed to the Phase II part. If more than 33% have unacceptable     toxicity, 12 additional subjects will be enrolled in a second cohort, if necessary. If     unacceptable toxicity is seen in more than 33% in Cohort 2, the study will end due to     unacceptable toxicity of this drug combination.      The phase II part of the study is a single arm study. All subjects will be treated with     carboplatin, nab-paclitaxel, and pembrolizumab in 21-day cycles for up to 4 cycles.      Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all     subjects (only if adequate archived samples are unavailable). Mandatory tumor biopsies will     be obtained in the Phase II part of the study after 4 cycles of study treatment or at the     time of progression, whichever comes first.      For subjects without progression of disease after Cycle 4, pembrolizumab will continue every     3 weeks for up to 2 years or until unacceptable toxicity.   "
69018|NCT02382393|"     The purpose of this study is to evaluate the concurrent validity (correlation coefficient of     scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a     validated third party computerized assessment.   "
69019|NCT02382380|"     This study is for individuals with decreased kidney function whose doctor has ordered     Magnetic Resonance Imaging (MRI). Because kidney function is decreased, these patients     usually do not receive the intravenous contrast material that can improve the accuracy of the     MRI findings. The purpose of this study is to evaluate the safety and benefit of using a     contrast material called Gadoterate in patients with decreased kidney function.   "
69020|NCT02382367|"     The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin     quantitative and functional deficiency in an adult French population presenting with     pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative     and/or functional deficiency will be displayed.   "
69318|NCT02378454|"     This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children     obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each     participants will perform the test (LCI) in duplicate on each device.   "
69024|NCT02382315|"     Fear of cancer recurrence (FCR) is one of the most frequently cited unmet needs among     survivors, and affects 22 to 87% of cancer patients. The objective of this study is to test     the effectiveness of a six weekly, 1-hour manual-based individual therapy to reduce FCR among     cancer survivors. A total of n=20 cancer survivors will be recruited from the Ottawa Hospital     Cancer Centre (TOHCC) in Ottawa, Ontario. Participants will be randomly selected to receive     either the psychotherapy intervention or standard care at TOHCC. All participants will be     asked to complete a series of questionnaire packages at 3 time points. Ultimately, decreasing     FCR can improve quality of life and reduce distress.The objective of this RCT study is to     test the effectiveness of a six weekly, 1 hour manual-based cognitive-existential (CE)     individual intervention to reduce FCR among cancer survivors. It is hypothesized that:        1. Participants in the intervention group will have lower scores on the primary outcome          measure of FCR after treatment, as compared to a standard care control group        2. Participants in the intervention group will have lower scores on the secondary outcome          measures of uncertainty, cancer-specific distress, intolerance of uncertainty, and          faulty beliefs about worrying, will demonstrate enhanced coping skills, and report          better quality of life after treatment, as compared to a standard care control group,          and these changes will be maintained at a 3-month follow-up.   "
69025|NCT02382302|"     This trial is a prospective research to evaluate efficiency in U-health solution service     based on Mobile for the chronic wound management.   "
69026|NCT02382289|"     Expecting using bipolar RF at six points, in spite of potentially consuming more     intraoperative time, to be more effective and long lasting in the management of pain     resultant from chronic sacroiliac joint arthropathy than the other 2 techniques using the     monopolar RF even if using six points.   "
69027|NCT02382276|"     The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with     alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.   "
69028|NCT02382263|"     In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the     6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000     deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the     USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%,     respectively. Most patients are diagnosed in advanced stages that are no longer operable, so     that treatment goals are often the prolongation of survival and palliation of symptoms.      The aim of the study is to explore whether the new combination nab-paclitaxel plus     gemcitabine is a therapeutic advance for this fragile population for which it is assumed that     some modifications in dose and schedule of administration may be necessary in patients with     good performance status. It is ultimately to find out the clinical benefit of this     combination, but first making sure that dose and schedule of the combination are tolerable     for these fragile patients.      For this, the investigators have chosen a design that includes two stages: the first step     aimed at choosing the safest treatment regimen for these patients among a group of treatment     regimens used in other clinical trials. The second step will evaluate the effectiveness of     the two regimens with the better results in the previous step.   "
69029|NCT02382250|"     This study is a prospective study of patients referred for coronary angiography at Bellevue     Hospital Center and NYU Langone Medical Center. Subjects enrolled in this study will complete     two one-page questionnaires, including information about diet, lifestyle, perceptions of     health and perceived barriers to healthy lifestyles. Patients will be contacted at one and     six months following their procedure to complete follow-up questionnaires to assess changes     in diet and perceptions of their health after knowing the results of their coronary     angiogram. The primary outcome measure will be change in dietary patterns/perception of     lifestyle between baseline and one- month and six-month follow-up. Secondary measures will     include association between dietary patterns/perception of lifestyle and degree of CAD and     socioeconomic status.   "
69030|NCT02382237|"     Evaluate the feasability to determine the difference of tumoral metabolism before and after     artificial nutrition.   "
69031|NCT02382224|"     The purpose of this study is to examine the efficacy of a worry exposure intervention, a form     of cognitive behavioral therapy (CBT), in comparison to a waitlist condition for the     treatment of Generalized Anxiety Disorder. There will be a total of 60 subjects enrolled at     the University of Texas at Austin. Patients will be randomized (like a flip of a coin) to     either 12-sessions of WE therapy or a 12-week waitlist before being offered entry into     therapy.   "
69032|NCT02382211|"     The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T     cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)]. The T-SPOT     platform technology can be applied to diagnose and monitor any major disease process driven     by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the     T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).   "
69033|NCT02382198|"     Sialorrhea is a frequently occurring problem with detrimental effect on quality of life in     25% of PD patients. Currently, there is no intervention approved for sialorrhea in Parkinsons     and evidence is only available for a 30-day effect or less. We hypothesize that     glycopyrrolate will have a lasting effect in the reduction of sialorrhea in PD patients.   "
69319|NCT02378441|"     This study is designed to evaluate safety and pharmacokinetic properties of the two     treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and     metformin SR 750mg, in healthy volunteers.   "
69066|NCT02381769|"     The study will be an experimental pre-post trial in which patients with ethanol related liver     disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from     Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive     polymeric blenderized kitchen based liquid diet while those tolerating orally would receive     soft/ solid diet as tolerated as per requirement. All the patients would receive same amount     of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non     protein calorie would be provided as fats and rest of the calories will be provided as     carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3     consecutive days, over and above the feed provided to them to be taken enterally (orally or     through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after     infusion.   "
69034|NCT02382185|"     Improving or maximising cardiac output in the perioperative setting through the use of goal     directed fluid therapy has been shown to reduce complications and length of hospital stay in     patients undergoing major abdominal surgery. The evidence for patients having surgery to     repair a fractured neck of femur is less robust but many of these latter patients are elderly     and often at high risk of complications.      Patients undergoing surgery (including surgery for hip fracture) under spinal anaesthesia     have not had access to goal directed fluid therapy because of the invasive nature of the     existing monitoring technology such as oesophageal doppler. The availability of a non     invasive cardiac monitoring device, the Clearsight™, now makes goal directed fluid therapy a     possibility for this group of patients.      This is a randomised controlled, observer blinded trial to assess the effects of goal     directed fluid therapy in high-risk patients undergoing surgical repair of proximal femoral     fractures.      The aim of the trial is to test the hypothesis that maximising circulating volume     intra-operatively with balanced crystalloid reduces post-operative morbidity in high-risk     patients undergoing urgent surgical repair of proximal femoral fractures.   "
69035|NCT02382172|"     Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and     following a group based clinical therapy program to determine the effectiveness of the     therapy approach. The therapy program is aimed at improving social cognitions and skills of     individuals who find social situations difficult, stressful and/or uncomfortable and with a     desire to enhance skills required for social interactions.      Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment     disorder, who have general difficulty with social interactions.      Procedures: Participants enrolled in a clinical therapy program for improvement of social     cognitions and skills will complete eye tracking tasks, several questionnaires and rating     scales, and a diagnostic interview prior to and following the 8 week therapy program. The     post treatment assessments will be conducted within a week of the therapy completion and then     again approximately 2 months after the last therapy session. The entire study duration is     expected to be approximately 17 weeks. These outcome measures will measure the effectiveness     of the treatment.   "
69036|NCT02382159|"     1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who          has done exogenous visit or hospitalization from Jan 2010 to June 2014.        2. Study objective:             1. The objective of this study is to Identifying the lipid parameter variation when               treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.             2. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months,               identifying the reason why changing method of drug dosage and pharmacotherapy.             3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid               parameter variation when treating patients by altered drugs for 3±1 months,   "
69037|NCT02382146|"     We designed this randomized, double- blind, single-center study to compare the efficacy of     the combination of dexamethasone with ondansetron and dexamethasone with dimenhydrinate     undergoing plastic surgery.   "
69038|NCT02382133|"     Continuous pulse oximetry monitoring is the standard of care in critically ill patients in     emergency departments, operating rooms and intensive care units. In patients with poor     peripheral perfusion (low blood flow) due to peripheral vascular disease, low body     temperature, or shock and the use of medications to raise the blood pressure, clinicians have     difficulty obtaining an accurate measurement. This study compares the accuracy of forehead     oximetry sensors to nasal alar sensors to lab oximetry measures and on the rate of device     related pressure ulcers with both.   "
69039|NCT02382120|"     Cardiac output monitoring is mandatory in most surgical and critical care patients. Many     techniques to assess cardiac output are invasive and/or have many limitations,     contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal     is an interesting option due to the simplicity and non-invasive nature of its calculation.      The present study was designed to compare the cardiac output measurement using a capnodynamic     formula versus the reference thermodilution method.   "
69041|NCT02382094|"     Phase III clinical trial to study quality of life in prostate cancer patients by randomizing     anti-androgen versus total androgen blockage prior to curative intended radiation therapy.   "
69042|NCT02382081|"     The primary objective of this research protocol is to evaluate the health related quality of     life and efficacy of patient-initiated hospital follow-up for patients with moderate to     severe psoriasis.   "
69043|NCT02382068|"     This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in     patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum     before chemotherapy may help protect against cisplatin-associated hearing loss.   "
69044|NCT02382055|"     The investigators are examining what types of psychotherapy are most helpful for patients as     they undergo weight restoration treatment for anorexia nervosa. In this study, patients who     are receiving care on our inpatient unit will also receive 4 weeks of one two types of     psychotherapy: Supportive Psychotherapy or Regulation Emotions and Changing Habits.   "
69065|NCT02381782|"     Over the last few years, there has been a considerable interest in the development of     screening tools to assess the capability of elderly cancer patients to tolerate anti-cancer     treatment. Therefore, the NCCN Guidelines in Senior Adult Oncology recommend an assessment of     co-morbid conditions that are likely to interfere with cancer treatment and tolerability. As     presbyacusis is common in an older population, elderly cancer patients are at high risk for     social isolation and a reduced quality of life. Therefore, in this project the investigators     aim to validatie uHear™ as a quick and reliable screening tool to screen for presbyacusisf in     routine clinical oncology practice.   "
69067|NCT02381756|"     The aim of this study is to evaluate, in an intensive care unit, the reproducibility between     two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson     method and of the calculation of GLS for the evaluation of the systolic function of the left     ventricle in critically ill patients intubated and ventilated.   "
69117|NCT02381106|"     The primary overall objective of this study is to characterize the levels of and compare     levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at     different time points in pregnancy, in normal and dysfunctional labor and also to measure     levels and expression of these receptors in placental arteries at different maturation     statuses of placenta and in pre-eclampsia/hypertension   "
69045|NCT02382042|"     Background Participation in continuing care is one of the two most significant factors in     preventing relapse after intensive Substance Use Disorder (SUD) treatment.1 A primary     component of continuing care, social support, is a protective factor for SUD treatment     relapse.2 Social support provided by community self-help groups (e.g. 12-step programs such     as Alcoholics Anonymous) improves Substance Use Disorder (SUD) treatment outcomes.1,4     Post-treatment referral to self-help groups was recently described as an effective, low-cost     option,3 but counselors vary in their referral methods, often simply telling patients to     find and attend meetings in their community.      In a study of urban veterans leaving treatment, researchers increased 1-year SUD abstinence     rates by more than 24% through a three-step intensive referral intervention.5 First,     counselors discussed the importance of social support and meeting attendance. Second,     counselors identified accessible self-help meetings near the SUD treatment site and arranged     for a meeting liaison to accompany the patient to a meeting. Third, counselors followed up on     attendance and addressed obstacles. A follow-up study found patients with co-morbid SUD and     psychiatric problems significantly benefitted from the intervention.6      The investigators have adapted this intervention so that it can be utilized in a rural as     well as urban setting. The investigators have trained clinical staff, measured their fidelity     to the intervention and successfully implemented it across three Veteran's Affairs (VA)     Substance Use Disorder (SUD) treatment programs (Omaha, Lincoln and Grand Island). In 2012 an     intriguing study showed that peer referral to 12-step support groups was significantly more     effective than clinician referral.7 This is of particular interest given the scarcity of     addiction counselors in rural communities and enhances the intervention's applicability to     rural settings and other disciplines.      Specific Aim The investigators propose implementing this intervention in a correction     population (Intervention Group) and comparing outcomes between the Intervention Group and a     group who are receiving standard correction services (Standard Group).      Methods Phase I: Adapt Intensive Referral Intervention for correction population Phase II:     Train correction staff in Intervention Research staff will train and continue to monitor     trained correction staff to ensure fidelity to intervention and provide feedback to staff and     leadership regularly.      Phase III: Comparison between Intervention Group and Standard Group The two groups will be     compared on measures of interest to the Nebraska Department of Correctional Services and on     measures of substance use, support group attendance and involvement at standard time points.   "
69046|NCT02382029|"     Objective: Burning mouth syndrome (BMS) is chronic oral condition characterized with burning     symptoms which affects perimenopausal and postmenopausal women. It seems that neuropathy     might be the underlying cause of the condition. There are still insufficient data regarding     successful therapy. The aim of this study was to compare efficacy of acupuncture and     clonazepam in 42 BMS patients (38 women, 4 men), age range 66.7±12 years.      Methods: Patients were randomly divided into two groups. Acupuncture was performed in group I     during four weeks, 3 times per week on the points ST 8, GB 2, TB 21, SI 19, SI 18, LI 4 on     both sides of the body as well as GV 20, each session lasted half an hour.Group II patients     took clonazepam two times a day (0.5 mg) in the morning and after two weeks two tablets (0.5     mg) in the morning and in the evening during the next two weeks. Prior to and one month after     either therapy, participants fulfilled questionnaires: visual analogue scale, Beck depression     inventory, LANSS pain scale, 36-item short form Health Survey (SF-36) and Montreal Cognitive     Assessment (MoCA). Statistical analysis was performed by use of Student t test and Pearson's     correlation test. P values lower than 0.05 were considered significant.   "
69047|NCT02382016|"     24-week study to evaluate the efficacy and safety of macitentan for the treatment of     portopulmonary hypertension.   "
69048|NCT02382003|"     The study aims to develop a web-based Cognitive Bias Modification infrastructure to train     interpretations, and evaluate the usability, acceptability, and feasibility of the program to     reduce anxiety symptoms.   "
69049|NCT02381990|"     Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by     Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome     measure is 5 year oncological control. Secondary aim is lack of progression beyond the     prostate gland. The aim of intervention is to eradicate prostate cancer disease in the     treated area while imposing no or minimal deleterious effects in quality of life.   "
69050|NCT02381977|"     PANGEA is an international prospective point prevalence study to describe the epidemiology,     interventions, and outcomes in children with acute critical brain disease.   "
69051|NCT02381964|"     When completing difficult tasks, the brain requires faster delivery of energy sources (oxygen     and glucose) via the blood. There is evidence to suggest that some nutritional supplements     may increase blood circulation in the brain which can result in improved task performance.     The purpose of the study is to evaluate the effects of a multivitamin/mineral preparation     (containing a range of vitamins and minerals as contained in commonly consumed     multivitamin/minerals available off the shelf) in healthy females on cerebral (brain) blood     flow and energy expenditure during cognitive task performance.   "
69052|NCT02381951|"     Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy     (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial     'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing     gait and walking.      Spinal cord stimulation is currently an important therapeutic option in the treatment of     neuropathic pain. Experimental and limited clinical data suggest that this technique might     also be used to alleviate motor symptoms and improve walking in Parkinsons patients.      This exploratory study aims at measuring the benefits of spinal cord stimulation on the     walking capacity of a small number of Parkinsons patients who are not adequately improved by     drug therapy alone.   "
69053|NCT02381938|"     This study will evaluate the efficacy of a 6-month child care-based intervention to improve     workers' physical activity and other health-related behaviors compared to an attention     control intervention (Healthy Lifestyles vs. Healthy Finances). The study sample will use a     cluster randomized design and a sample of 104 child care centers and 416 child care workers     (4 workers/center). The intervention arm will receive a 6-month child care-based intervention     designed to improve workers' moderate to vigorous physical activity (MVPA) and other     health-related behaviors (Healthy Lifestyles). The control arm (attention control) will     receive a similarly structured program about financial health (Healthy Finances). The primary     outcome is workers' MVPA; and secondary outcomes include workers' dietary intake, weight,     smoking, sleep, and stress, as well as the centers' health supportive policies/structures for     staff wellness and the overall physical activity environment for children. All primary and     secondary outcomes will be assessed at baseline, post-intervention (6 months), and     maintenance (18 months).   "
69102|NCT02381301|"     Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed     countries. In addition, many patients suffer from valvular and aortic disease. Although     various tools are available to identify patients with cardiovascular (CV) disease at risk for     major adverse cardiac events (MACE), the identification of these patients remains a clinical     challenge.      One promising avenue is the use of different serum biomarkers involved in atherothrombosis     which could provide an easy and cost-effective step in risk stratification.   "
69054|NCT02381925|"     The study aims are:        1. To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT),          scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary          hyperparathyroidism.        2. To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused          parathyroidectomy, and for rates of persistent hyperparathyroidism and complications          from parathyroid surgery.      Methods The investigators will create a multicenter registry consisting of patients having     parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial     participating centers include Duke University Medical Center, University California Los     Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS).      There will be no intervention in the patient's treatment or imaging. The management will be     determined by the surgeon or clinician supervising the patient's care.      The registry will consist of patient data regarding basic demographics, history of prior     neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative     surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months     (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be     entered into REDCap with no PHI. The investigators expect to include 3000 patients in the     registry (1000 from Duke).   "
69055|NCT02381912|"     The purpose of the study is to investigate sexual function in patients suspected of non     muscle invasive bladder cancer (NMIBC). The investigators hypothesis is that reduced sexual     function is underdiagnosed in patients with non-muscle invasive bladder cancer and that     active examination and treatment may worsen the sexual function.   "
69056|NCT02381899|"     The purpose of this observational study is to provide additional data to confirm the safety     profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic     leukemia patients treated in routine clinical practice.   "
69057|NCT02381886|"     A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132     mutations.   "
69058|NCT02381873|"     This exploratory study will quantify and describe patient-reported and objective measures of     sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and     levels of habitual physical activity prior to and around the time of surgery.   "
69059|NCT02381860|"     Scientific studies in humans suggest that diets high in fruit and vegetables may be able to     improve some aspects of mental performance such as improving memory and reaction times. One     reason that that these improvements may occur is that these compounds contain phytochemicals     which may increase blood flow and, therefore, the delivery of oxygen and nutrients to the     brain. If this is the case it is possible to measure this increased blood flow by a     non-invasive technique called Near Infrared Spectroscopy. The purpose of this study is to     examine the effect of a fruit juice on cerebral blood flow and cognitive function   "
69060|NCT02381847|"     Patients with histological proven advanced gastric cancer (including cancer of the     esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the     inclusion and exclusion criteria, can be recruited in this study. There are two treatment     groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients     randomized into group B will be treated with an intraperitoneal (in the abdominal cavity)     chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A     will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of     postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and     are followed up for 24 months.   "
69061|NCT02381834|"     Urinalysis and urine culture are commonly employed laboratory tests in the Emergency     Department (ED), particularly for the purposes of investigating febrile infants in whom     bacterial etiologies must be ruled out. The standard of care for obtaining sterile urine     specimens in this age group remains transurethral bladder catheterization, an invasive     procedure that is painful and has the potential for causing specimen contamination and     iatrogenic urinary tract infection (UTI). A recent study by Herreros Fernández et al (2013)     described a novel bladder stimulation technique for newborns that facilitates midstream urine     collection. The success rate for this procedure was 86.3%. It remains unknown however as to     whether this technique is reproducible amongst infants who present to the ED with a     potentially greater severity of illness. The primary objective of this study is to determine     the success rate of this technique in children ≤ 90 days old in the ED.   "
69062|NCT02381821|"     100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These     patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a     3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed     up after treatment to determine the rate of implantation.      Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the     junctional zone at day 21 of the cycle.   "
69063|NCT02381808|"     To understand 295 gene mutation mutation status (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect)     by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships     with the patients' clinical features (including sex, age, smoking history and adenocarcinoma     subtype), specify the predictive significance of the genes mutations for new targeted     therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to     EGFR-TKIs.   "
69064|NCT02381795|"     This is an open label, investigator-sponsored, pilot study. Subjects agreeing to participate     in the study and meeting the eligibility criteria assessed at the screening visit will be     enrolled in the study. The length of time between screening and treatment will last between 0     days to a maximum of 12 weeks. Subjects who enter the screening phase during a cluster     headache episode and meet the study eligibility criteria can immediately enter the treatment     phase and may opt to treat their cluster headache episode in the clinic. Subjects who are not     in a cluster headache episode, who meet initial screening eligibility criteria, can remain in     the screening phase for up to 12 weeks until their next cluster episode begins. Upon     initiation of a cluster headache episode, subjects will enter the treatment period. Subjects     will be trained on the proper use of the hand-held dispenser containing carbon dioxide (CO2     )calibrated to deliver 0.5 standard liters per minute (SLPM). This dispenser will be provided     for use in the clinic or home. Subjects will be instructed to use the nasal CO2 dispenser, 10     seconds/nostril, as needed up to 6 times to treat one attack. Each dose must be separated by     3-5 minutes. Subjects should treat only one attack in a 24-hour period. Subjects may treat up     to three cluster headache attacks during the treatment phase of this study. One hour after     the first dose, subjects can choose to treat with investigator-approved rescue medication.     Subjects will be asked to complete an online diary after the completion of the dosing. Diary     assessments will collect pain severity, nasal CO2 usage, acute medication usage, satisfaction     of treatment, number of cluster attacks, and unusual symptoms. Subjects will be contacted by     phone within 3 days of the first use of the nasal CO2 dispenser to assess adverse events     (AEs) and medication usage. A total of 25 subjects will enter the treatment period and be     instructed to treat up to 3 cluster headaches with nasal CO2. Within 7 days of treating their     last cluster headache episode, subjects will return for an end of study visit.   "
69068|NCT02381743|"     Community health workers (CHWs) provide essential basic medical care to hundreds of millions     of people across the globe. CHWs offer a myriad of services including community sanitation,     breast feeding counseling, family planning, management of febrile children, and malaria     control and prevention, to name but a few. In fact, CHWs are often the only source of primary     health care available to some of the most disadvantaged populations in the world. However, to     be effective, CHWs must be trained - and retrained - at regular intervals, and the costs for     such trainings can be substantial. In the US, clinicians are required to stay current and     maintain their competence through continuing medical education (CME). Increasingly, CME     activities are delivered via internet-based, self-teaching modules. A typical example would     be a set of topical readings followed by multiple-choice questions, with the answers, and CME     credit, provided to the user upon satisfactory completion of the module. This content is     typically delivered over the Internet. However, there is no intrinsic reason why this     approach could not be adapted so that CME activities are delivered using standard cell phones     via SMS text messaging. This would significantly expand professional training opportunities     to a far greater range of CHWs than possible through computer/tablet/smart phone platforms,     and would be particularly valuable in poorer countries with limited training budgets. In the     mCME project, the investigators propose to test the effectiveness and cost effectiveness of a     mobile phone-based CME delivery strategy among Vietnamese community-based physician     assistants (CBPAs), a cadre of CHW mandated to provide primary health care to rural and     disadvantaged populations. The investigators hypothesize that providing CME activities over a     mobile platform will significantly improve their professional knowledge, and may also improve     their job satisfaction and self-efficacy.   "
69069|NCT02381730|"     Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is     often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response     to anti-vascular agents differs from the response of typical AMD.      This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV     patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).   "
69070|NCT02381717|"     The goal of the study is to evaluate whether pain control achieved by Ultrasound Guided     Femoral Nerve Blockade (USFNB) is equal in efficacy to standard pain management practice of     parenteral injection of opioid pain medication in patients presenting to the emergency     department (ED) with hip fracture.   "
69071|NCT02381704|"     The overall purpose of the study is to determine prospectively the cost effectiveness of     bariatric surgery following partial coverage by a large healthcare system.   "
69072|NCT02381691|"     Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates     Design : A prospective, randomised, controlled, double blinded, monocentric trial.      Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were:     neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea     and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th     percentile according to Olsen curves et al. They also had to be: clinically stable, with 48     hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in     the last 48 hours and without any underlying disease. The two legal representatives must have     signed an informed consent. The study excluded the neonates for whom no video was recorded     during the venipuncture.      In the first group breast milk, venipuncture was performed to the neonate while his     mother's milk odor was being diffused. In a second control group, the same gesture was made     with an odorless diffusor. The primary outcome was the clinical score assessment PIPP     (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of     Newborn) and the salivary cortisol level.   "
69073|NCT02381678|"     The objective of the study is to obtain the clinical data from patients who had the Perimount     Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during     2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the     patients' post-operation infomation including the current living status, mortality rate, and     the possibility of re-operation，bleeding and thrombosis.      This is a retrospective , observentional clinical study to be conducted in Guangdong General     Hospital in China. This study will enroll up to 200 patients.   "
69080|NCT02381587|"     sjogren syndrome is an autoimmune disease that mainly affects the Salivary glands and     Lacrimal gland In addition to the effects of this disease is characterized by overall     systemic Muskals injury, pulmonary disease, peripheral neuropathy and vasculitis. In addition     recent studies have shown that patients are at increased risk of the disease up to 2 cardiac     events and stroke events Hydroxychloroquine is an RHEUMATIC DISEASE PROCESS     SUPPRESSANTS-ANTIMALARIALS used to treat anti-inflammatory rheumatic diseases in many     first-line treatment is sjogren syndrome.      A recent study of the treatment in Hydroxychloroquine effect on lipid profile sjogren     syndrome patients showed a reduction in total cholesterol levels and increase in HDL. Further     studies of the impact made Hydroxychloroquine systemic lupus patients erythematosus (SLE)     showed in Atherosclerosis and morbidity and mortality reduction in cardiovascular. Studies of     patients with rheumatoid arthritis (RA) demonstrated reduced risk of developing diabetes and     improved lipid profile Research Goals valuate The effect of HCQ treatment in cardiovascular     patients with primary sjogren syndrome   "
69081|NCT02381574|"     Primary Objective:      To evaluate the rate of re-operation during the first 5 years following the fitting of lumbar     total disk replacement at the operated level and / or floors above and / or underlying,     whatever the reasons   "
69103|NCT02381288|"     The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks     of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to     middle-aged and older men with low ST levels.   "
69084|NCT02381535|"     This phase I trial studies the side effects and best dose of heat shock protein-90 (Hsp90)     inhibitor AT13387 when given together with intensity-modulated radiation therapy (IMRT) and     cisplatin in treating patients with squamous cell carcinoma of the head and neck that has     spread from where it started to nearby tissue or lymph nodes. Hsp90 inhibitor AT13387 works     by blocking a protein called HSP90. HSP90 helps protect cells from stress and supports many     other proteins that cause cell growth. When HSP90 is blocked, tumor cell growth may be slowed     or stopped and may die more easily when treated with chemotherapy and radiation. Drugs used     in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. IMRT is a specialized radiation therapy that delivers beams of radiation of     different intensities aimed at the tumor from many angles and may kill more tumor cells and     cause less damage to normal tissue. Giving Hsp90 inhibitor AT13387 with cisplatin and IMRT     may kill more tumor cells.   "
69074|NCT02381665|"     Chronic constipation is a strong public health problem. Its prevalence is about 15% in     Western countries with a significant impact on quality of life and health care costs . Two     subtypes of constipation can be identified: slow transit constipation (STC), characterized by     impaired propulsion of stool and due to dysfunction of colonic smooth muscle (myopathy) or     its innervation (neuropathy), or both; and evacuation disorders, characterized by difficulty     or inability with stool expulsion. They include disorders of the anorectal function such as     dyssynergic defecation, as well as structural disorders such as rectocele, descending     perineum syndrome and rectal prolapse .      The first line therapy of chronic constipation is based on medical treatment combined with     laxatives and dietary rules. However, these treatments are often disappointing. In case of     failure, few treatment options are currently available. Surgery can sometimes be discussed     for intractable chronic constipation. Sub-total colectomy can be proposed in case of STC but     is associated with a significant morbidity. In case of pelvic floor disorders, a specific     surgical treatment can be indicated. However, surgery is invasive, has a significant     morbidity and the results are inconsistent. Recently, some studies have assessed the efficacy     of sacral neuromodulation in the treatment of chronic constipation with some success, but     this technique is expensive and requires the surgical implantation of a medical device . More     recent works, including a randomized trial have showed, in children, the efficacy of     interferential current stimulation in the treatment of chronic transit constipation . This     treatment is used daily, at home, and uses four adhesive surface electrodes, two abdominal     (placed below the costal margin) and two paraspinal (placed between T9 and L2) producing two     sinusoidal currents crossing the body, 1 hour per day for 1-3 months. To date, only one     open-label study has evaluated this technique in adults and has shown encouraging results in     three months with an efficiency on 7/11 patients (63.6%) in the number of stools, severity     score of constipation, quality of life's score associated with improved bowel transit time     measured by radio-markers.      Interferential therapy is a new treatment that has demonstrated its efficiency in the     treatment of chronic constipation in children. Our team has published the first and only     pilot study in adults that also demonstrated encouraging results. These data are of     particular interest since laxative treatments are often disappointing, are expensive and may     have adverse events.      This study would be the first randomized study to evaluate a non-invasive and     non-pharmacological treatment of chronic constipation in adults.      If its effectiveness is demonstrated, it will provide, for the first time, a new non-invasive     step for patients with laxative treatment failure before considering surgical treatment.   "
69075|NCT02381652|"     The objective of this study is to evaluate the safety of a repeat injection of Cingal® in     subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01. This will be     done through examination of the incidence of adverse events and physical examination of the     knee.   "
69076|NCT02381639|"     The current etiological pathological model of anorexia nervosa is poly-factorial involving     individual genetic and psychological factors, in close interaction with environmental, family     and socio-cultural factors.      Among these factors, this study focuses on the central coherence process (cognitive ability     to integrate complex information into a comprehensive meaning), in the active phase of the     disease. Therefore, patients followed in the addiction service of the Nantes University     Hospital will perform neuropsychological tests assessing executive functions involved in the     process of central coherence.      Impairment of central coherence process could act as a maintenance factor of the disease,     particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting     on the central coherence process like cognitive remediation deserve to deepen knowledge on     the cognitive profile of patients with anorexia nervosa.   "
69077|NCT02381626|"     The purpose of this study is to look at air quality in cabs and see if the air quality inside     taxi cabs is connected to increased risks for lung and heart health problems. Another purpose     of the study is to see if putting an air filter inside the car may help improve the air     quality and lower health risks.      This is important because air pollution can be harmful to health. Air pollution is made up of     very tiny particles (things) floating in the air around us, called particulate matter.     Particulate matter is made up of dust, smoke, dirt, and gas fumes and can get into our bodies     as we breathe. It has been linked to risk for lung cancer and heart disease. It is important     because taxi drivers spend many hours of their day inside their cars.      The investigators hope that this study will help them find out if using air filters inside     cabs will help lower the levels of pollution in cabs and reduce its effects on the health of     taxi drivers. They will use these results to educate the taxi driver community.   "
69078|NCT02381613|"     While observational studies often find that diets rich in fish reduce the risk of disease,     and that diets including a high intake of red meat are associated with increased risk of     cardiovascular disease and cancer, the difference in health effects between red meat and fish     are rarely researched in intervention studies.      The investigators hypothesise that the post-prandial plasma response of lipids and markers of     cardiovascular disease risk will be more favourable after intake of herring compared to beef.      In addition, while pickling herring in a brine/sugar solution is a common form of     preparation, little is known if there is a difference in potential health effects based on     the preparation of herring. The investigators will compare baked and pickled herring to     understand if preparation is potentially an important factor to be considered when looking at     intake of fish and health.   "
69079|NCT02381600|"     Background: Ageing is associated with an increased risk of cognitive decline and depression.     Vitamin D plays an important role in many of the symptoms and conditions related to advanced     age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological     effect on the function of the central nervous system, and studies have suggested a     relationship between this vitamin and changes in affect and cognitive function in the     elderly. The investigators propose a pilot study to examine the relationship between     below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in     the elderly.      Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH     Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the     treating family physicianfor screening. Subjects will be required to provide written informed     consent for inclusion in the study. Exclusion criteria will include any active or unstable     medical condition as determined by the treating physician, known neurocognitive disorder,     known affective disorder, the use of any class of antidepressant drugs, the use of     supplements containing vitamin D in any dose, significant visual or hearing impairment not     corrected by spectacles or hearing aids, and a level of literacy that limits cognitive     ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized     cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive assessment     battery, and the 15-item Geriatric Depression Scale. All subjects will undergo repeat testing     for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will     receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for     a period of 3 months. At 3 months subjects will undergo repeat testing for level of 25-OH     Vitamin D, and repeat computerized cognitive assessment using the Neurotrax Mindstreams     battery and the 15-item Geriatric Depression Scale (GDS).   "
69082|NCT02381561|"     This phase I trial studies the side effects and best dose of ropidoxuridine in treating     patients with gastrointestinal cancer that have spread to other places in the body and     usually cannot be cured or controlled with treatment undergoing radiation therapy.     Ropidoxuridine may help radiation therapy work better by making tumor cells more sensitive to     the radiation therapy.   "
69083|NCT02381548|"     This phase I trial studies the side effects and best dose of WEE1 inhibitor AZD1775 and     belinostat when given together in treating patients with myeloid malignancies that have     returned after a period of improvement or have not responded to previous treatment or     patients with untreated acute myeloid leukemia. WEE1 inhibitor AZD1775 and belinostat may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
69085|NCT02381522|"     The purpose of the study is to investigate if briefly stopping blood flow to the patient's     leg will lead to the patient's body being better able to tolerate possible decreased blood     flow to regions of the brain which otherwise frequently happens after subarachnoid     hemorrhage.      Previous studies show that various organs such as the heart, brain or kidney can tolerate     longer periods of decreased blood flow if prior to that insult shorter periods of decreased     blood flow were experienced.   "
69086|NCT02381509|"     PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of     commercially available IVC filters from 6 manufacturers placed in subjects for the prevention     of pulmonary embolism (PE). This study will enroll approximately 1,800 IVC filter subjects at     up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months,     6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. The primary     objective of this investigational device exemption (IDE) clinical investigation is to     evaluate the safety and effectiveness of the commercially available IVC filters (retrievable     and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC     filter.   "
69087|NCT02381496|"     This is a three-part study to assess the tolerability, safety, pharmacodynamics, and     pharmacokinetics of ascending single doses (including food interaction) of ACT-453859 in     healthy male subjects, of ascending multiple doses of ACT-453859 in healthy male and female     subjects, and of multiple doses of setipiprant (ACT-129968) in healthy male and female     subjects.   "
69088|NCT02381483|"     Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical     studies, however the role of retinoids in human brown fat physiology and energy metabolism     remains elusive. This study aims to identify a possible association between retinoid     metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using     FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic     profile of white and brown neck fat biopsies at room temperature and cold conditions in a     subset of the study participants. More detailed molecular studies (involving other potential     browning markers) will also be performed in adipocytes derived from human SVC.      The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects     will be repeatedly exposed to cold and circulating retinoid levels and other plasma     parameters will be measured at various time points.   "
69089|NCT02381470|"     Faropenem is an oral penem, closely related to the carbapenem class that is used for the     treatment of bacterial infections. It has in vitro activity against Mycobacterium     tuberculosis and this trial aims to determine the activity of faropenem with     amoxicillin/clavulanic acid in patients with pulmonary TB.   "
69090|NCT02381457|"     This multi-center prospective observational study is designed to track birth outcomes and     perinatal correlates to the Panorama prenatal screening test in the general population among     ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy     screening as part of their routine care. The primary objective is to evaluate the performance     of Single Nucleotide Polymorphism (SNP)-based Non Invasive Prenatal Testing (NIPT) for     22q11.2 microdeletion (DiGeorge syndrome) in this large cohort of pregnant women. This will     be done by performing a review of perinatal medical records and obtaining biospecimens after     birth to perform genetic diagnostic testing for 22q11.2 deletion. Results from the follow-up     specimens will be compared to those obtained by the Panorama screening test to determine test     performance. Specific test performance parameters will include: PPV, specificity, and     sensitivity.   "
69091|NCT02381444|"     The aim of this study is to assess the effect of LCIG (levodopa-carbidopa intestinal gel) on     HRQL (Health-Related Quality of Life) of participants and compare the Health-Related Quality     of Life between participants continuing to levodopa-carbidopa intestinal gel treatments     versus participants continuing on oral therapy for Parkinson's Disease.   "
69092|NCT02381431|"     The purpose of this study is to see if thermal images can be used instead of a chest x-ray to     diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur,     India. More specifically, the objectives of the study are: 1) to determine if thermal     imaging, using a commercial thermal camera can accurately detect the presence of bacterial     pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use     of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed     with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of     infection that are suspected to be related to the pneumonia.   "
69093|NCT02381418|"     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in     influenza vaccines can vary from year to year. The current study is a phase III A clinical     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The     objective of this study is to investigate the immunogenicity and safety and tolerability of     the changed influenza vaccine virus composition in two groups of subjects in good health:     subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).   "
69094|NCT02381405|"     This is an open label, randomized investigation of a proprietary blend of amino acids, called     Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or     chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue     standard of care. Two patients will be enrolled on the treatment arm for each patient on the     control arm.   "
69104|NCT02381275|"     Lighthouse, in cooperation with the University Heidelberg Public Health Institute and the     University Köln (Cologne) would like to set up a cohort to study baseline characteristics and     long-term clinical outcomes of patients using Tenofovir based Antiretroviral Therapy at the     Lighthouse. As of March 2014, patients above 18 years and giving informed consent coming to     the Lighthouse to newly initiate ART will be approached to enroll in the cohort.      The results will be disseminated both nationally at the Ministry of Health Technical Working     Group (TWG), at the annual Research Dissemination and Best Practices conferences of the     College of Medicine and National AIDS Commission as well as internationally. The results will     also be written up for publication in appropriate peer-reviewed journals.   "
69291|NCT02378805|"     The hereditary type IV collagen disease Alport syndrome inevitably leads to end-stage renal     disease. Currently there are no therapies known to improve outcome. Our non-interventional,     observational study investigates, if medications such as ACE-inhibitors can (1) delay time to     dialysis and (2) improve life-expectancy within three generations of Alport-families in     Europe.   "
69095|NCT02381392|"     Obtaining intravenous (IV) access in children under the age of 2 years is difficult,     especially in the emergency department (ED) where the children can be frightened, dehydrated     and ill. Often it requires multiple needle sticks and nurses to place an IV in a difficult     child. In our ED the recently acquired an Accuvein AV400 device. This infrared light, like a     barcode scanner, makes the veins on a child appear like roads on a map. This ideally shows     the nurse where to place and direct the needle. This device is approved by the FDA to work     with children and has not been shown to have any harmful effects. However, there are no     studies showing whether this device helps in the difficult less than 2 year olds seen in the     emergency department.      This study will be to directly compare placing an IV in a child under 2 years of age with the     AV400 versus not using the device. A physician, medical student, or nurse practitioner who     has been trained on how to observe nurses place IVs will enroll children who require an IV     for their ED clinical care (as determined by their ED doctors). This person will consent the     parents, ask the parents questions regarding the child's past medical history, and have the     nurse look at the veins of the child ahead of the IV access attempt to rate the level of     difficulty expected (easy, moderate, difficult). Whether the child has the IV attempt     performed with or without the AV400 will be computer randomized. The nurse will attempt to     place the IV, and the study staff will observe and record the number of attempts, size of the     IV catheter, and location of the IV. If 2 attempts are failed, the patient will cross over     to the other condition, that is if AV400 was being used then it will not be used, and if     AV400 was not being used then it will be used. If there are 4 failed attempts at IV     placement, then the child will be treated as per our department's difficult IV access     protocol, which is applied to all children with difficult IV access regardless of     participation in the study. After the IV placement, both the parents and the nurse will be     asked several questions regarding satisfaction with use of the AV400.      No patient identifiers will be collected.      The investigators will be recruiting 260 children to determine if using the AV400 device     improves the first time needle stick success from 40% to 60%.      Nursing approval for the study was obtained prior to the study.   "
69096|NCT02381379|"     To compare administration of peginterferon-α-2a for 1 year versus observation after stopping     tyrosine kinase inhibitor (TKI) in chronic myeloid leukemia (CML) patients with deep MR ≥ 2     years.   "
69097|NCT02381366|"     PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord     blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular     therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an     open-label, single-center, dose escalation study to evaluate of safety and efficacy of     PNEUMOSTEM® in premature infants at high risk for BPD.   "
69098|NCT02381353|"     After surgery to remove the eye, either by enucleation or evisceration, patients have     variable levels of pain for several postoperative days. Some patients have almost no     discomfort while others require significant amounts of oral narcotics and report pain of 10     out of 10 on a numerical rating scale. The current operative standard is to infiltrate the     eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative     analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable     suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative     pain control for up to 72 hours. This medication has been used in numerous surgeries     including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and     orthopedic surgery, and the literature reports improved pain control, decreased use of oral     opioids, and increased patient satisfaction. There are no reports of the use of Exparel in     the ophthalmic literature. The investigators propose a randomized, controlled trial to     compare the postoperative pain control offered by sustained release bupivacaine to that     offered by standard plain bupivacaine after enucleation or evisceration.   "
69099|NCT02381340|"     Obesity and its associated conditions have reached epidemic proportions. Estimates are that     about one third of the adults in the United States have obesity. At this moment there are     many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment     options are limited and so far surgical intervention has been proven to be the only strategy     to overcome severe obesity. However, bariatric surgery has limitations and risks, which might     be minimized by non-incisional endoscopic procedures.      BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM)     Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which     intends to reduce the ability of the stomach to expand by creating plications in the region     of the fundus and greater curvature. In contrast with other bariatric surgery it is     endoscopically performed, reversible and if it fails most future surgical options are still     open.      The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness     of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC     and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this     plicating system for patients with severe obesity.      In this sub-study we want to unravel the exact mechanism and provide more information about     the efficacy of the BaroSense ACE™ Stapler. Therefore we will measure changes in various     parameters that are known to affect weight loss and metabolism, before and after gastric     plication (by using the BaroSense ACE™ Stapler) in overweight subjects (these parameters will     only be measured in patients at MUMC+). These parameters are post-prandial satiety,     food-reward and related brain signalling, gastric emptying, behaviour towards food, food     intake, satiety hormone release, microbiota composition and inflammatory markers.      Objectives:      Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on     postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour     towards food, food intake, hormone release, microbiota composition and inflammatory markers.   "
69100|NCT02381327|"     Patients diagnosed with Binge Eating Disorder (BED) overeat food but, as opposed to patients     with bulimia nervosa, they do not compensate for their increased food intake and therefore     their body weight increases. It is hypothesized that the speed of eating has increased in BED     and that body weight will decrease if the speed of eating is decreased. The speed of eating     is measured using Mandometer, an eating disorder conditioning tool, class 2 device cleared by     the FDA for the treatment of eating disorders. Mandometer is a scale connected to a computer,     patients eat food from a plate on the scale and the computer stores the weight loss of the     plate, thus recording the speed of eating. Patients decrease their speed of eating by     following training curves on the computer screen while eating. The emergence of their own     speed of eating on the screen makes this possible. Patients use Mandometer for lunch and     dinner over one week at home to estimate their speed of eating and their food intake as the     first step of clinical pratice. Mandometer is then programmed with how much and how quickly     to eat and patients practice eating using Mandometer at home over the subsequent treatment.     Data from 166 BED-patients using Mandometer at home and from a total of 354 patients who have     been treated have been collected. 30 normal weight, healthy subjects will be recruited to     test the hypothesis that their speed of eating is lower than that of the BED-patients. These     control subjects will eat lunch and dinner using Mandometer at home over one week, but they     will, obviously, not participate in treatment.   "
69101|NCT02381314|"     The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination     with Yervoy (ipilimumab) when given to patients with B7-H3-expressing melanoma, squamous cell     carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC) and other B7-H3     expressing cancers. The study will also evaluate what is the best dose of enoblituzumab to     use when given with ipilimumab. Assessments will also be done to see how the drug acts in the     body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity     of enoblituzumab in combination with ipilimumab.   "
69171|NCT02380378|"     This study was developed to document current diagnosis and treatment patterns, clinical     outcomes, and health care resource use associated with Philadelphia-Negative     Myeloproliferative Neoplasms, in the different risk classifications for each disease.   "
69105|NCT02381262|"     Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve     gastrectomy surgery, the investigators would like to determine if the Fitbit is associated     with health outcomes in this population.      Primary Outcome      • Percentage of excess weight loss - Does the use of a Fitbit positively affect the     percentage of excess body weight loss in vertical sleeve gastrectomy patients?      Secondary Outcomes        -  Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive          lifestyle and exercise pattern changes in post-operative VSG patients?        -  Resolution of comorbidity - Does the use of a Fitbit positively affect patient health          via reduction of co-morbid conditions associated with morbid obesity following VSG          surgery?   "
69106|NCT02381249|"     Improvements to treatment strategies for patients with cancers of the upper gastrointestinal     tract have produced a large population of people who remain free from cancer recurrence in     the long term following treatment.      Surgery is the cornerstone of treatment for patients with these cancers, but while surgical     removal of the tumour may offer the best chance of cure, these are major operations     associated with specific long term complications. Weight loss and poor nutrition are common     problems among patients who attain long-term cancer remission and cure after surgery. The     mechanisms underlying these problems are not well understood and therefore treatment options     are limited.      Our research has demonstrated increased levels of chemical messengers (gut hormones) released     from the gastrointestinal tract after meals in patients who have previously undergone this     type of surgery. These chemical messengers play a role in controlling appetite and interest     in food, and increased levels after surgery may reduce interest in eating. Understanding the     role of gut hormones in the control of appetite may allow us to use certain medications to     block gut hormones and hence increase appetite, allowing patients to eat more and regain     weight, preventing nutritional problems after surgery.      In this study, the investigators aim to determine whether exaggerated gut hormone secretion     causes reduced appetite and interest in food after surgery. The information gained from this     study may help us to develop treatments for patients with weight loss and nutritional     problems after surgery.   "
69107|NCT02381236|"     A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the     perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic     resonance imaging (mpMRI).   "
69108|NCT02381223|"     This study aims to collection additional data on the safety and acceptability of medical     abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.   "
69109|NCT02381210|"     A cross sectional study design will evaluate the diagnostic value of the CRD test to the     pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil     Inguarán, tertiary level facilities in Bangladesh and Mexico City.   "
69110|NCT02381197|"     A population-based prospective cohort design will evaluate the progression of urine     congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally     across gestation in Bangladesh and Mexico City.   "
69111|NCT02381184|"     One hundred and thirty six anovulatory women with CC-resistant PCOS were scheduled randomly     into two equal groups. Group A (n=68); received CC (100 mg/day from cycle day 3 for 10 days)     for up to six cycles. Group B (n=68) underwent LOD and followed up for 6 months. The primary     outcome was the ovulation rate in each group; secondary outcomes were midcycle endometrial     thickness and serum estradiol, midluteal serum progesterone, and the rates of clinical     pregnancy and abortion.   "
69112|NCT02381171|"     To evaluate the hypothesis: the effects of repetitive transcranial magnetic (rTMS)     stimulation and/or peripheral stimulation (neurofunctional electrical acupuncture) treatments     are more effective in pain relief than placebo-sham in patients with myofascial chronic pain.   "
69113|NCT02381158|"     This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone     dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg     nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in     children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of     symptoms and exacerbations, will be assessed.   "
69114|NCT02381145|"     In this double-blind, randomized, placebo-controlled study, we aim to investigate the effects     of a long-term supplementation on insulin sensitivity, mitochondrial function and substrate     metabolism in healthy overweight men and women.      In each group, 21 subjects consume 100mg Resveratrol (RSV) and 150mg Epigallocatechin-gallate     (EGCG), respectively Placebo capsules, twice daily over a period of 12 weeks. The subjects     receive the capsules after the last pre-measurement and continue to take them throughout the     post-measurements.      Before and after the supplementation period, we perform a hyperinsulinemic-euglycemic clamp     with a glucose-tracer infusion to assess hepatic and systemic insulin sensitivity.     Simultaneously, substrate oxidation is measured throughout the clamp by indirect calorimetry.     Furthermore, we perform a high-fat mixed meal test, in which we collect blood and measure     substrate oxidation during fasted and postprandial conditions. During the meal tests, extra     plasma is collected at the start (t=-30) and the end (t=240), of which the supernatant is     stored in light-protected tubes (EGCG is mixed 1:1 with an EGCG buffer) for analyzing     polyphenol concentrations in the blood.      In the male subgroup (21 men), we additionally place each 2 microdialysis probes in the     subcutaneous adipose tissue and the gastrocnemius in order to assess local lipolysis and     blood flow by means of ethanol infusion.      Furthermore, a dexa-scan is performed to assess body composition and biopsies are taken under     fasted conditions from the subcutaneous adipose tissue and the quadriceps femoralis muscle.     These samples are stored at -80C. Part of the adipose tissue samples is collected to measure     adipocyte size. Of the skeletal muscle biopsy, one part is directly buffered and used for the     oxygraph to measure mitochondrial function.      At last, feces samples are collected before and after the intervention in order to assess     energy content, microbial composition and short-chain fatty acid content.      Based on previous human studies in our and other departments, we hypothesize that after 12     weeks of the combined polyphenol supplementation, insulin sensitivity and mitochondrial     function improve. Furthermore, based on results of a short-term study performed by our group,     that demonstrated an increase in energy expenditure, a positive effect on the regulation of     body composition might be expected.   "
69115|NCT02381132|"     The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco®     7.5mg/325mg when used for the treatment of moderate to severe post operative pain.   "
69116|NCT02381119|"     This study addresses the challenge of increasing compliance with dietary recommendations and     guidelines among diabetes type 2 patients by introducing professional dietary advice based on     individual requirements.      The objective of this study is to assess the effect of the Personalized Dietary Advice     Services (PDAS) after a three month intervention on established markers of nutritional and     health status in diabetes type 2 patients (HbA1c, glucose, insulin). Besides, the effect of     the PDAS on perceived health status of diabetes type 2 patients will be assessed.   "
69292|NCT02378792|"     Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator     to patients with refractory epilepsy.   "
69118|NCT02381093|"     The current method of teaching Basic Life Support (BLS) courses involves a practice schedule     where learners rotate through each station once, without repetition. Laypeople learning     within this blocked schedule may experience poor skill retention, resulting in suboptimal     delivery of Cardiopulmonary Resuscitation (CPR). Implementing a Contextual Interference (CI)     practice scheduling method to BLS training would involve presenting each station multiple     times within the same timeframe. CI is known to lead to better retention in other domains,     such as sport and engineering. Our project will test the effect of CI on the long-term     retention of BLS skills. We hypothesize that participants trained in BLS using CI techniques     will have superior skill retention at 3 months compared to those trained with the     conventional BLS course.   "
69119|NCT02381080|"     The purpose of this study is to assess the effect of a moderate Cytochrome P450 (CYP) 3A     inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state     pharmacokinetics (PK [the study of the way a drug enters and leaves the blood and tissues     over time]) of repeated oral doses of ibrutinib in participants with B-cell malignancy     (cancer or other progressively enlarging and spreading tumors).   "
69120|NCT02381067|"     The study is intended to demonstrate that the NuCel® allograft is effective and safe in     promoting bone growth and fusion rate when used in cervical fusion in patients with one, two     or three-level diseases of the cervical spine.   "
69121|NCT02381054|"     The purpose of this study is to see if the Italian language version of a questionnaire about     symptoms that patients may have during cancer treatment is understandable to Italian speaking     patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S.     National Cancer Institute to help get information about patients' symptoms directly from the     patients themselves. The Italian version of the questionnaire will be used in future studies     to gain a better understanding of patient symptoms.   "
69122|NCT02381041|"     This study aims to compare two vasoconstrictive agents topically applied in cosmetic     rhinoplasty: cocaine HCl 5% and adrenaline 1:1000. Blood loss during surgery as well as     systemic effect of the studied agents are evaluated.   "
69123|NCT02381028|"     The aim of this small pilot study is to assess the potential effects and risks of applying     fresh human milk locally on eczema spots in children with atopic eczema. This is a split     body, controlled, randomized and physician blinded pilot study, of children with atopic     eczema with two similar contralateral eczema spots having a mother breastfeeding the child or     a sibling. Fresh expressed milk and emollient is to be applied on the intervention spot and     emollient alone on the control area, three times a day for four weeks. Severity and area of     the eczema spots is evaluated weekly, and samples from milk and the spots were analysed     weekly with respect to bacterial colonisation.   "
69124|NCT02381015|"     This study was designed to compare the efficacy, perception, decision making, and     cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate     cancer and for chemoprevention of prostate cancer.   "
69125|NCT02381002|"     Background: Obesity is associated with alterations in iron metabolism leading to iron     deficiency.      Aim: to study the prevalence of obesity among primary school students, assess iron status     among overweight/obese children with age ranging between 6 and 12 years and the effect of     weight reduction program on iron status.      Patients and Methods: The study will be conducted on 2 groups. Group 1 will include 1025     primary school children recruited from 2 urban schools in Cairo with age ranging between 6     and 12. Anthropometric measures and prevalence of overweight/obesity will be assessed. Group     2 will include 100 obese children according to the CDC definition and 50 age and sex matched     children with normal weight. All will be subjected to history taking, anthropometric     measures, complete blood picture, iron profile and soluble transferrin receptor. Weight     reduction program for 6 months will be done for obese children and all parameters will be     re-ckecked.   "
69126|NCT02380989|"     Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common     painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs     (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects.      Ancient Indian healing system, Ayurveda addresses the need of sports medicine up to certain     extent. In practice, there are different treatment modalities for injuries, uses of drugs &     dietetics as well as practices of rehabilitation. Although, previous evidences support the     efficacy of ayurveda practices with significant reduction in pain, joint tenderness, joint     swelling, mobility restriction and early morning joint stiffness. But there is no treatment     studies have been performed to evaluate the clinical outcome for specific sports injuries.      This study assessed the efficacy and safety of ayurveda gel and patches applied to the     painful injury site for the treatment of acute minor sports injury pain.   "
69127|NCT02380976|"     A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative     bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.   "
69128|NCT02380963|"     Dietary protein is a key element of most effective weight loss regimens. This study will     investigate the effects of consuming soy protein on body composition and cardiometabolic     health within the context of an effective weight loss and maintenance program called the     Colorado Diet.   "
70032|NCT02369133|"     The investigators designed a prospective randomized study to investigate the efficacy of     intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction,     total morfin consumption and the incidence of morfin‑related side effects in patients     undergoing cesarean section.   "
69129|NCT02380950|"     Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster     resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol     effects after gastric bypass we suggest that also general cognitive function is stronger     impaired.      Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8     normal weight subjects) in the study. Each participant had to drink 250 ml white wine.     Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions     were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm.     During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes     with breathalyser Dräger Alcotest 7510.   "
69306|NCT02378610|"     The relationship between the gut microbiota and stress is poorly studied in humans. In this     study we aim to look for if stressed persons have different levels of key bacterial groups     compared to the levels in non-stressed persons.   "
69130|NCT02380937|"     The Radio Frequency Ablation for Atrial Flutter with Magnetic Resonance Guidance and Tracking     Pilot Study (hereafter referred to as pilot study) is a prospective, non- randomized,     single-center, pilot study. The purpose of this clinical study is to evaluate the safety and     performance of the Imricor Medical Systems, Inc. (Imricor) Vision Ablation Catheter when used     with related accessories for the treatment of type I atrial flutter. The Vision Ablation     Catheter and its accessories have been designed for use under fluoroscopic or magnetic     resonance guidance.   "
69131|NCT02380924|"     This is a randomized, single-blind, single-center, concurrently controlled, exploratory,     Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50     survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient     volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to one     of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).   "
69132|NCT02380911|"     Hypercholesterolemia, a major cause of disease burden in both the developed and developing     world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third     of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the     prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%,     whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was     37.3 % and the proportion of those who are under pharmacological treatment was dismally low:     only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of     coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on     statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and     low-dose aspirin were available free-of-charge at the primary care clinics of the public     sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg)     were incorporated into the package of drugs provided free-of-charge for patients with high     cholesterol, according to CVD risk stratification. The goal of this study is to test whether     a multifaceted educational intervention targeting physicians and pharmacist assistants,     improves detection, treatment and control of hypercholesterolemia among uninsured patients     with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will     test whether a multifaceted educational intervention program lowers LDL-cholesterol levels     and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance     with clinical practice guidelines, and improves patient care management and adherence to     medication. A cost-effectiveness study will be conducted to compare the intervention to the     usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public     primary care clinics who will be assigned to receive either the intervention or the usual     care. This study is timely and will generate urgently needed data on effective and, practical     and sustainable intervention programs aimed at the prevention and control of CVD risk that     can be directly used in other primary care settings and health care systems in LMICs.   "
69133|NCT02380898|"     Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of     intraoperative shoulder tip pain and improve discomfort during Caesarean section.   "
69134|NCT02380885|"     The study evaluates the effectiveness of the social cognition and interaction training     (SCIT), in comparison to both therapeutic alliance focused therapy (TAFT) and treatment as     usual (TAU) among persons with severe mental illness. Study purpose: 1) Assess the     effectiveness of the SCIT and TAFT interventions, 2) Assess the processes that putatively     contribute to the SCIT and TAFT outcomes. Method: A Randomized Controlled Trial (RCT) with     approximately one hundred and fifty persons with severe mental illness will be carried out in     different psychiatric rehabilitation units and clinics in Israel. To assess the relative     effectiveness of the SCIT and TAFT interventions with persons with severe mental illness,     both interventions will be compared to treatment as usual (TAU). Clinicians will be trained     in both interventions, and outcome measures, including social quality of life and social     functioning, as well as mediating processes, including the identification of affective     states, ToM, attribution errors and therapeutic alliance, will be assessed. Cognitive     functioning and symptom severity will be treated as covariates. Statistical analyses will     include analysis of variance which takes into consideration attrition, effect size, mediation     processes and covariates.   "
69135|NCT02380872|"     The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and     -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival     crevicular fluid during the early and late stages of healing for gingival recession sites     treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus     connective tissue graft. As PRF consists of several growth factors, it may enhance the     healing potential of soft tissues, the investigators hypothesized that using PRF in the     treatment of gingival recessions might regulate inflammation and promote wound healing.   "
69136|NCT02380859|"     Subjects diagnosed with Idiopathic Parkinson's Disease, between ages of 40-85 inclusive, who     have been referred for gait training. Since there can be subtle differences in the brain     organization of left- and right-handed people that may influence some of the measurements,     right handed participants are preferred. However, a left handed participant may be     considered. Participants will be randomly assigned to one of two groups to undergo two weeks     of twice-daily sessions. Group A receiving goggles fitted with lenses that distort vision and     Group B patients receiving sham goggles   "
69172|NCT02380365|"     Experimental intervention: electrocardiography. Control intervention: none      Duration of intervention per patient/subject:      5 min, observation 6 months      Key inclusion criteria:        -  outpatients after lung transplantation (single, double or combined)        -  outpatients on the wait list for lung transplantation      Key exclusion criteria:      • no informed consent   "
69173|NCT02380352|"     Randomized controlled double-blind non-inferiority clinical trial to determine whether five     days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with     10 days of high-dose amoxicillin for previously healthy children with mild community-acquired     pneumonia.   "
69410|NCT02377258|"     The primary objective of I-CARE is to assess prospectively the presence and the extent of     safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF     alone or in combination with thiopurines among IBD patients.      We will stratify the risk of cancers and serious infections according to IBD phenotype and     disease activity (clinical, radiologic and endoscopic).   "
69228|NCT02379624|"     Acute lower gastrointestinal dysfunction is a kind of much common complication which occurred     in critically ill patients. Once it developed, enteral nutrition would be disturbed. In this     study, investigators suppose that early application of a sufficient amount of pectin ahead of     enteral nutrition, may promote recovery of acute lower gastrointestinal dysfunction in     critically ill patients, and exert its good effect on early EN support.      Investigators designed this prospective randomized controlled trial to test and evaluates the     effect whether EN feeding with or without a pectin start would be safe or with advanced     clinical outcomes.   "
69307|NCT02378597|"     To develop and test a 4-session program to teach resiliency skills to Medical Interpreters.   "
69137|NCT02380846|"     This study aims to find out how consuming different proteins with rice affect metabolism.     Most meals the investigators eat predominantly consist of a carbohydrate and protein (i.e.     rice, noodles, bread etc with meats or seafood). However, it is still unknown how consuming     different proteins with commonly eaten carbohydrates affect metabolism. Previous studies have     shown that proteins stimulate hormones such as insulin, glucagon and gut hormones. However,     the extent of the response depends on protein type. The metabolic responses to carbohydrates     have also been shown to be greatly affected when they are eaten with proteins. However, most     of the previous studies have used glucose as the carbohydrate and it is still unknown how     eating proteins with carbohydrate foods such as rice affect metabolism. Therefore, this study     has been initiated to determine the metabolic effects of eating different protein types with     rice. Using the most common carbohydrate eaten in Asia (rice) and four commonly eaten protein     foods (egg, chicken, fish and beancurd), this study aims to observe the metabolic effects of     co-ingesting proteins and carbohydrate. The resulting data will provide valuable insights     into the metabolic effects of protein-carbohydrate meals and will be useful in the     development of practical advice and dietary guidelines for those with chronic diseases (such     as diabetes and obesity).   "
69138|NCT02380833|"     The purpose of this study is to determine the effectiveness of recommending either a     Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with     or without exercise on physical conditioning, hormones related to energy metabolism, body     composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.   "
69139|NCT02380820|"     The main objective of this study is to compare the Softform Premier mattress (in static mode)     and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.   "
69140|NCT02380807|"     This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in     Patients with Fibromyalgia Syndrome.   "
69141|NCT02380794|"     Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant     proportion of the population with an age-adjusted prevalence of approximately 12%.     Claudication induced walking impairment can be debilitating and adversely affects social,     leisure, and occupational activities in many patients and is associated with higher mortality     among PAD patients.      Unfortunately, very few effective therapies are available to improve leg symptoms and     exercise performance in PAD patients. Surgery is the last resort but results vary. Therefore,     there is a large unmet need for medical therapies that can improve long-term walking     performance and functional capacity in PAD patients.      Danshen and Gegen (D&G) are commonly used Chinese herbal medicine in the treatment of     cardiovascular diseases. D&G study has been extensively researched and continued at The     Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties,     modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized trials     were completed at the CUHK showing D&G improved lipid profile, vascular function and thinned     down the internal layer of the carotid artery. One may expect the same with lower limb     arteries. Extensive clinical experiences of use in China and Hong Kong indicated that D&G are     well tolerated and safe.      This project is a randomized control trial to determine the efficacy and Safety of D&G in     improving the functional capacity & QoL in patients with symptomatic PAD. The results of this     study have the potential to change local and international practice in providing a much     needed therapeutic option in the treatment of PAD.   "
69142|NCT02380781|"     This is a prospective randomized control trial in which we propose an intervention in the     immediate post-partum period to educate women about contraceptive options, particularly long     acting reversible contraception (LARC) methods with an aim of increasing the amount of women     who choose a LARC method.   "
69143|NCT02380768|"     The purpose of this study is to determine whether there is a clinically relevant difference     in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA)     Supreme.   "
69144|NCT02380755|"     Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy     exists regarding if its a condition that needs to be treated. The standard Testosterone     Therapy is associated with increase in cardiovascular risks, according to some studies, and     leads to infertility. The use of Clomiphene Citrate in this sub population of obese man as an     alternative treatment option is not well studied. The aim of this protocol is to evaluate the     cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized     placebo trial.   "
69145|NCT02380742|"     The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce     pain and discomfort at the time of vaginal pessary removal and insertion. Half of the     participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will     receive a placebo cream.   "
69146|NCT02380729|"     The MENDEL-study will investigate whether the use of gene panel or whole genome sequencing     (WGS) will:        1. improve the rate of diagnosis and through this compare the performance of the two          diagnostic approaches (gene panel vs. WGS),        2. investigate whether use of said sequencing approaches early in the diagnostic process          results in reduced health care spending, and        3. result in an improved quality of life for the patients and their parents.   "
69147|NCT02380703|"     This study will evaluate whether a home-based targeted education and skill training     (Agression Prevention Training or APT) will reduce aggression in persons with dementia (PWD)     and pain/pain-related features more than usual care plus supportive telephone calls. Half of     the participants will receive APT and half will receive supportive telephone calls.   "
69148|NCT02380690|"     To maximize implementation potential of pain self-management in the VA, alternative delivery     methods are needed to provide Veterans with education and support needed to self-manage their     pain, without requiring additional resources from healthcare teams. A novel and promising     approach is a peer coaching model, in which Veterans with chronic pain who are successfully     managing their pain offer information, support, and mentorship to other Veterans with pain.   "
69149|NCT02380677|"     A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until     determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and then     enrollment into Phase 2a expansion cohorts will be initiated.   "
69411|NCT02377245|"     The investigators created a cohort of patients with juvenile inflammatory rheumatisms with     the purpose to follow them prospectively, and investigate the tolerance and efficacy of     immunosuppresive and biological agents.   "
69150|NCT02380664|"     Swimming training is associated with decreased bone mass and lower bone mass acquisition     during growth periods, mainly when compared to other weight-bearing sports. Little     information is available in adolescents pointing in the same direction but still     controversial.      On the other hand, bone strength do not only depends on bone mass but on bone structure and     microarchitecture. The cross sectional area, cortex thickness or trabecular density are     important aspects of bone health. There are few studies on the effect of swimming on bone     architecture of adolescents. This information is relevant for present and future health of     adolescents practicing swimming and for all the organizations promoting this sport. Jumping     and whole body vibration training programs seem to elicit important osteogenic effects;     however, there is little information on this regard in adolescent population, even less in     these adolescents with potentially decreased bone acquisition such as swimmers.      The main aims of this research project are therefore, to analyze the effect of swimming     training on bone mass, metabolism, structure and architecture in adolescents analyzing     possible relationships among them. Secondly, to test whether including short boots of jumping     or whole body vibration may be able to palliate the possible deleterious effects of swimming     and facilitate a normal or even healthier bone development. And finally to study the     durability of training-related bone gains over time.   "
69151|NCT02380651|"     This study aims to assess the functional ability and health-related quality of life (HRQoL)     of upper extremity sarcoma patients who have undergone limb salvage surgery.   "
69152|NCT02380638|"     The main aims of the present project include 1) to study the longitudinal effects of     whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2) to     evaluate whether a low frequency vibratory training program consisting of 3 sessions per week     for 9 months (each vibratory session last approximately 10 minutes and includes 5-6 bouts of     1 min with 1 min rest between bouts) can improve bone development in these populations.     Finally, and additional aim of the project is 3) to determine how long these effects may last     after the end of the intervention.   "
69153|NCT02380625|"     The purpose of this study is to determine whether multiple therapeutic regimens are effective     in the treatment of Ebola Virus Disease (EVD)   "
69154|NCT02380612|"     This is a randomized, within-subject controlled study to compare the clinical performance of     the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin     grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1)     confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a     blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio     of measured treated area to the measured donor site area, achieved for the ReCell-treated and     control treatment areas. Safety will be evaluated in terms of long-term durability, scar     outcomes and treatment-related adverse events.   "
69155|NCT02380599|"     Spinal mobilization and spinal manipulation are common techniques utilized in the field of     physical therapy. Despite their common utility, little is known about the physiological     mechanisms underlying the changes experienced following the interventions. Recent research     suggests that neurological mechanisms may be involved in the post interventional changes, but     research supporting this view is still evolving. Therefore, this study will explore whether     there is a neurophysiological difference between spinal manipulation and spinal mobilization     techniques. The neurophysiological difference will be measured by monitoring heart rate     variability, a cardiovagal indicator of autonomic nervous system activity. The primary     hypotheses of this study are three-fold, first that spinal manipulation will result in a     change in heart rate variability that is different then sham intervention. Second, spinal     mobilization will result in a change in heart rate variability that is different then sham     intervention. Finally, the investigators hypothesize that spinal mobilization and spinal     manipulation will produce different changes in heart rate variability.   "
69156|NCT02380586|"     A national survey of current practices, preferred drug and technique choices for obstetric     anesthesia and analgesia in Czech Republic and Slovak Republic.   "
69157|NCT02380573|"     A double-blind, placebo-controlled study that aims to investigate the effect of 2-week and     12-week administration of USP methylene blue (MB) on cerebral blood flow, functional     connectivity, memory and attention cognitive abilities using fMRI and behavioral measures in     healthy aging, mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) subjects.   "
69158|NCT02380560|"     100 women divided into 3 groups:        -  Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50)          with gestational age from 24 to 34 weeks.        -  Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37          to 41 weeks.        -  Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from          24 to 34 weeks.The myometrial thickness at 4 different sites9:           a) The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder          (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan          probe perpendicularly above the uterine fundus so that the entire curvature of the          uterus was visualized.           (d)The posterior wall: through using the maternal abdominal aortic pulsation as an          anatomic marker.      At least 3 measurements were obtained at each site and averaged. The latency interval is     determined in each of the 3 groups.   "
69159|NCT02380547|"     Usefulness of non invasive ventilation in patients extubated after more than 48 hours of     invasive ventilation is still in debate except for specific patients (chronic pulmonary     disease and chronic heart failure).      Many experimental and clinical studies have shown that diaphragmatic function is depressed by     mechanical ventilation in intubated patients.      The investigators will test the hypothesis that non invasive ventilation after extubation may     improve diaphragmatic function   "
69160|NCT02380534|"     To evaluate the effects of H.E.L.P. apheresis on lipid profile, Lp(a) level, and some     inflammatory adypocytokines in patients with high cardiovascular risk.   "
69187|NCT02380170|"     The study aims to get an insight on the causative bacteria of sepsis derived from the urinary     tract. Furthermore, it is the intention to understand the outcomes of these patients. For     this purpose a non-interventional, observational study will be conducted.   "
70060|NCT02368769|"     The purpose of the study is to assess whether performing a frozen section diagnosis off site     with virtual slides would be as quick and accurate as usual technique.   "
69161|NCT02380521|"     The glucagon-like peptide 1 (GLP-1) agonist exenatide represents an effective therapy in     patients with type 2 diabetes mellitus (T2DM), which also seems to have some important     non-glycemic effects. Yet, these non-glycemic effects are still largely unknown.      The effect of exenatide once weekly was investigated in controlled, blinded and open-label     clinical studies in subjects with T2DM who were controlled on diet and exercise alone or in     combination with oral antidiabetic agents, but also in multi-dose controlled studies and such     studies resulted in significant reductions in glycemic parameters (mean glycated hemoglobin     (HbA1c), fasting serum/plasma glucose as well as postprandial plasma glucose levels), but     also in body weight, over 24 to 30 weeks. Meaningful reductions were observed as early as     week 4 of treatment, and maintained through 6 years of treatment.      The study investigating cardiovascular effects of exenatide once weekly is currently     undergoing. The results available are not numerous (such as DURATION-2, DURATION-3,     DURATION-4 studies) and cannot lead to definitive conclusions.      In this study the investigators will evaluate the effect of exenatide once-weekly on multiple     cardiovascular risk markers. These markers are related to subclinical atherosclerosis,     endothelial dysfunction, oxidative stress and atherogenic lipoproteins.      The investigators will perform an open label, single-arm, prospective, intervention study     using exenatide once weekly for a period of 8 months on 60 patients with T2DM.   "
69162|NCT02380508|"     TB038 is a clinical study to assess the non-specific effects of BCG vaccination and gain a     better understanding of how the body's immune system reacts to BCG and in turn potentially     prevents infection from other bacteria.   "
69163|NCT02380495|"     Studio Nava is a National Study aiming to assess allergic rhinitis and asthma outcomes on     Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. Studio     Nava also proposes the innovative use of a web platform (http://nava.ibim.cnr.it/) that     contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI,     Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents;     Rhinasthma; VAS scale), that will be available for the doctors after the registration to the     web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to     fill them during the waiting time of the visit.   "
69164|NCT02380482|"     Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality     in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve     the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial     dysfunction might occur at the early phase of the traumatic brain injury. This myocardial     dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case,     improving myocardial dysfunction may help to increase cerebral blood flow and improve patient     prognosis. In clinical practice the easiest and non invasive way to explore myocardial     dysfunction is with transthoracic echocardiography. The objective of this trial is to     investigate myocardial dysfunction at the early phase of traumatic brain injury, compared     with a controlled group without TBI.   "
69165|NCT02380469|"     The purpose of this study is to investigate whether a systematic early assessment of     uncovered needs for information, supplemented by an interview about the needs with the     patient's nurse who seeks to provide the information requested, will improve the caregivers'     and the patients' satisfaction with information and communication and potentially also     decrease anxiety and depression.   "
69166|NCT02380443|"     This is a single center, open label dose frequency escalation study of InSituVax personalized     anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with     intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer vaccine step     combines killing a single metastatic tumor lesion by use of cryoablation in order to cause     the release of tumor-specific markers to the immune system and then injecting bioengineered     allogeneic immune cells (AlloStim®) into the lesion as an adjuvant in order to modulate the     immune response and educate the immune system to kill other tumor cells where ever they     reside in the body.   "
69167|NCT02380430|"     In France, there are no precise data regarding perioperative organization of medical     structure and care management of ambulatory surgical patients. Particularly, data on     management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and     treatment are needed, in several groups of patients.   "
69168|NCT02380417|"     This is a prospective observational trial of patient undergoing lung transplantation who have     a thoracic paravertebral catheter(s) placed for postoperative pain control. Patients pain     scores and opioid use were evaluated for 7 days after placement as well as any complications,     opioid adverse events, and length of stay.   "
69169|NCT02380404|"     1. Hypothesis/Specific aims      The aim of the present study proposal is to validate an implant treatment concept in the     edentulous upper maxilla using four implants-supported locators abutments to retain removable     prosthesis.      Specific aims:        -  The primary objective of the study is to evaluate the implant and prosthodontics success          rates of the proposed implant treatment approach after a follow-up period of 1, 3 and 5          years as well as the biological and prosthodontics complications.        -  The secondary objective is to assess the evolution of patient centered outcomes with the          suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL) and          patients' satisfaction relating to their prostheses will be considered.        -  The third objective will be to compare the implant, prosthodontics and patient-centered          outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT)          versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST).      Hypothesis:        -  Implant survival rate using this treatment concept is similar to restoration with          implant-supported fixed prosthesis, based on published data. No difference of implant          survival rates is found between ANT and POST implant distribution.        -  Prosthodontics survival rate using the following treatment concept is similar to the          ones found with a bar, based on published data. The ANT implant distribution causes          fewer prosthodontics complications compared to the POST implant distribution.        -  There is a significant improvement in OHRQoL and patient satisfaction compared to the          baseline OHRQoL observed with a conventional removable denture. The levels of          improvement OHRQoL and patient satisfaction are similar for ANT and POST implant          distributions.   "
69170|NCT02380391|"     Elevated on-treatment platelet reactivity is an independent risk factor of major adverse     cardiovascular events following percutaneous coronary intervention or ACS. People living with     HIV patients have a higher risk of recurrent events after ACS than people without HIV.      The investigators hypothesized that this increased risk is driven by higher platelet     reactivity.      Using a nested case-control study design, HIV-infected and HIV-uninfected patients with a     first episode of Acute Coronary Syndrome (ACS) treated with percutaneous coronary     intervention were matched for age, sex, known diabetes mellitus and anti-platelet therapy.      The primary end-point was the residual platelet reactivity (RPA) on dual antiplatelet therapy     assessed by light transmission aggregometry (LTA, 20µM ADP).      The study was conducted in a two large public university hospitals in central Paris, France.   "
69202|NCT02379962|"     The purpose of this study is to collect date related to public knowledge and attitude towards     biospecimen-based research and their willingness to participate in biobanking in China.   "
69174|NCT02380339|"     Uncontrolled diabetes is associated with increased risk for micro-vascular complication.     Hypoglycemia is one of the major barriers in achieving good glucose control. Hypoglycemia is     associated with a range of unpleasant symptoms including palpitations, tremor, hunger,     sweating, confusion, difficulties in thinking as well as other idiosyncratic symptoms. Fear     of hypoglycemia (FOH) refers to phobic avoidance reactions associated with hypoglycemia FOH     may increase behavioral attempts to avoid hypoglycemia including decreased consumption of     insulin and/or increased consumption of carbohydrates, resulting in poor glycemic control and     an increased risk of diabetic complication. In this study, the investigators present a novel     system, which simultaneously employs BioFeedback and Virtual Reality in order to cope with     fear of hypoglycemia.   "
69175|NCT02380326|"     Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB),     confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic     path of pulmonary lesions in the non-oncological patient.   "
69176|NCT02380313|"     This study is being conducted to characterize the safety and recommended phase 2 dose (RP2D)     of combining afuresertib, independently with 2 approved drugs: enzalutamide (Xtandi®, Xtandi     is a trademark of Astellas Pharma, Inc. ) and abiraterone (Zygita®, Zytiga is a trademark     of Janssen Biotech, Inc.). The study will be conducted in two parts. Part 1, a dose     escalation phase, will establish RP2D of afuresertib when administered with enzalutamide or     abiraterone. Part 2, a dose expansion phase, will further evaluate long-term safety of the     combinations at the RP2Ds in additional subjects. Dose-finding cohorts will be studied in     parallel and will evaluate safety and pharmacokinetic to guide selection of the dose regimens     for further evaluation. Part 2 will begin once the RP2Ds have been established in Part 1.     Additional doses and/or schedules may be explored if warranted, based upon the     pharmacokinetic (PK) and pharmacodynamic (PD) assessments or emerging preclinical evidence.     Overall, approximately 60 chemotherapy-naïve subjects with mCRPC and who are receiving either     enzalutamide or abiraterone will be enrolled into the study.   "
69177|NCT02380300|"     The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance     Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).   "
69178|NCT02380287|"     This is an open label, phase 1, 3+3 dose escalating study of tolerability, safety,     pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel     monoclonal antibody against human IL-17 - BCD-085. The study will enroll 37 healthy male     volunteers.   "
69179|NCT02380274|"     The purpose of this study is to describe patterns of care in CRPC patients, as well as     health-related quality of life (HRQoL) outcomes associated with CRPC and its management.      This study will also describe factors influencing treatment decisions including reason(s) for     treatment choices and triggers for treatment changes for CRPC as well as describe clinical     outcomes based on patient characteristics.   "
69180|NCT02380261|"     The purpose of this study is to verify the skin and ocular tolerance of the product Systane®     Lid Wipes.   "
69181|NCT02380248|"     The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry     eye subjects following 90 days of QID (4 times/day) dosing.   "
69182|NCT02380235|"     This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin)     Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of     population of children.   "
69183|NCT02380222|"     The purpose of this study is to explore the key symptoms of individuals with systemic     mastocytosis. Interviews of enrolled individuals will be conducted to learn about the disease     symptoms and condition. The interview will last approximately 60 minutes and will be     conducted by a trained interviewer, be audio-recorded (with patient consent), and all     information provided by the patient will be treated confidentially and made anonymous so that     it is non-identifiable. The interview may be conducted face-to-face, over the phone, or     virtually via Skype, a free video conferencing program, depending upon the patient's     geographic location. Patients will be compensated for their participating time.      This is not a medication-related study, and no medication will be distributed or tested     during this study. Participation in this study will not affect any treatment or assistance     that a patient currently receives or may receive in the future.   "
69184|NCT02380209|"     Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer     (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI     scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.   "
69185|NCT02380196|"     The primary objective of this study is to determine whether circulating tumor cells (CTCs)     can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (Stage     I) non-small cell lung cancer (NSCLC). Patients scheduled to undergo surgical intervention     will have blood samples obtained to test for CTCs. Presence of CTCs will be compared to final     pathologic diagnosis based on surgical specimens to assess the sensitivity of using CTCs     alone to make a definitive diagnosis.   "
69186|NCT02380183|"     This is an openly randomized controlled parallel group study evaluating the effectiveness of     using a guided approach and free-hand approach in performing upper extremity regional blocks.     Potential subjects for this study are the patients who are scheduled for upper extremity     surgeries requiring supraclavicular and interscalene brachial plexus blocks at Montefiore     Medical Center.      Rotating residents who are participating in the study will be randomly assigned either to     perform block under guided approach (with the help of needle guidance) or free-hand without     the needle guidance. All the blocks will be single injection blocks utilizing the in-plane     technique for needle insertion which is the usual protocol in our institution. Each resident     will be performing one interscalene block with the device and one without the device and one     supraclavicular block with device and one without the device. An independent observer will be     present during the case and will be responsible for recording the time taken to perform the     block, number of times the needle has been redirected and the number of times the needle is     reinserted. This observer will also administer the satisfaction questionnaire. Number of time     needle is redirected and number of times reinserted is also a self reported assessment by the     physician who is performing the block. Efficacy of the block will be assessed by the standard     of care practiced at our center.   "
69203|NCT02379949|"     This randomized clinical trial compares virtual reality exposure therapy to exposure group     therapy to a waiting list control group.   "
69188|NCT02380157|"     Project titel: Oral potassium supplementation in healthy men - interactions with the     renin-angiotensin-aldosterone system and the sympathetic nervous system Protocol number:     KARAASS-1 EudraCT number: 2013-004460-66      Introduction The global burden of hypertension is huge. This project focuses on the role of     potassium in human blood pressure regulation. A potassium rich diet lowers blood pressure and     some studies have shown an increase in blood pressure during potassium depletion. Thus an     inverse correlation between potassium intake and blood pressure exists. In this trial the     objective is to test how an oral potassium supplementation, administered in form of the drug     Kaleorid®, interacts with the renin-angiotensin-aldosterone system and the sympathetic     nervous system.      Methods This is a randomized clinical placebo-controlled double-blinded crossover trial. A     group of healthy men will be randomized to either 4 weeks treatment with the drug Kaleorid®,     750mg, 3 tablets 3 times daily or to 4 weeks treatment with placebo.      On day 26 in the first treatment period the participants meet at the hospital to start a     24-hours ambulatory blood pressure and collect a 48-hours urine sample. The same day a blood     sample, an electrocardiogram (ECG) and a fat biopsy from the gluteal region will be done. The     fat biopsy is expected to contain resistance vessels, which are to be investigated further in     the laboratory.      On day 28 in the first treatment period the participants meet at the hospital again and are     tested with an intravenous Angiotensin II infusion followed by continuous measurement of     blood pressure and the following aldosterone response (using blood samples). Blood pressure     will be measured with Finger Plethysmography and vascular tonus will be evaluated with the     use of Impedance Cardiography, Finger Plethysmography and Doppler Ultrasound measurements of     blood flow before, during and after the Angiotensin II infusion.      After this first period of treatment and testing a washout period of two weeks is inserted.     After washout, the participants crossover and starts the second treatment period.      Feasibility All necessary authorities have approved the trial and all cooperation is     established.   "
69189|NCT02380144|"     The study was designed as a randomized 2-way cross-over study to assess the bioavailability     of carotenoids and flavonoids from sweet oranges and orange juice. Volunteers followed a     wash-out period for 2 weeks prior to eating either 400 g of fresh oranges or 719 g of orange     juice. The amount of test food was adjusted to deliver an equal amount of β-cryptoxanthin     (740 µg). After a consecutive wash-out period of 2 weeks, the procedure was repeated and the     volunteers ingested the complementary test food. Blood samples were collected at 8 time     points up to 9.5 h after test meal consumption. Additionally, 24 h-urine was collected to     evaluate flavonoid recovery.   "
69190|NCT02380131|"     Stage I：preoperative therapy        -  Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients          with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage          II: Perioperative therapy        -  Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant          Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2          positive gastric cancer with liver metastasis;   "
69191|NCT02380118|"     The purpose of this study is to determine whether IM olanzapine is safer (fewer adverse     events) and more effective (shorter time to sedation) than conventional haloperidol or     midazolam when used in the management of acute agitation in the emergency.   "
69192|NCT02380105|"     This study aims to evaluate the effectiveness of counseling on pain, function and well-fare     outcomes for the management of patients with temporomandibular disorder (TMD).   "
69194|NCT02380079|"     The purpose of this study is to determine the safety and clinical effects of SCD-101 when     given to adults with sickle cell disease.   "
69195|NCT02380066|"     The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are     effective in the treatment of Depression.      And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in     the Chinese Patients with Depression.   "
69196|NCT02380053|"     What are the differential effects of beta-blockers on lung and heart function during exercise     in chronic obstructive pulmonary disease (COPD)? COPD is a major cause of illness and death.     Not only do these individuals suffer from lung disease, but COPD often leads to other     illnesses, particularly heart disease. Beta-blockers very successfully treat heart disease.     It is therefore logical that one would want to use this treatment in COPD patients with heart     disease too. However, there has always been concern that beta-blockers could cause     significant problems in COPD by worsening lung function, as these can have the opposite     effect to inhalers used to treat COPD that open up airways. Pointedly, there is increasing     evidence that despite this problem, COPD patients who have been prescribed beta-blockers have     been shown to gain benefit particularly in terms of preventing death.      In this study, the investigators therefore want to examine which beta-blocker might be the     safest for COPD patients, as each work slightly differently. Some beta-blockers may have a     more beneficial effect on airways than others, whilst still benefitting the heart. The     investigators will study two different beta-blockers; one that potentially narrows airways     and one that potentially opens airways. The investigators will be using cardiopulmonary     exercise testing (an exercise bike that measures both heart and lung function during     exercise) to look for differences between both beta-blockers primarily in terms of lung     function but also with information about the heart. The investigators will recruit people     with moderate to severe COPD who are able to complete a cycle exercise test through their     respiratory research department. The study will last for 10-12 weeks with 5 main visits to     the department for serial exercise tests, breathing tests, simple heart function tests and     simple blood tests that will tell the investigators what other effects these beta-blockers     are having on the heart and lungs.   "
69197|NCT02380040|"     Photoplethismography will be measured and compared in newborns suffering from patent ductus     arteriosus and normal controls.   "
69198|NCT02380027|"     This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy     compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each     participant will be randomly allocated to one of the biopsy tests.      We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers     than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS     biopsy.   "
69199|NCT02380001|"     The purpose of the present investigation is to evaluate the effectiveness of the preoperative     administration of Dexketoprofen Trometamol, employing the third molar surgery model, when     compared to postoperative administration of the same drug. It was hypothesized that     preoperative oral Dexketoprofen trometamol will reduce the intensity of pain by 30% after 8     hours of the surgery, when compared with post-operative administration.   "
69200|NCT02379988|"     This is a pilot study to determine whether the addition of inspiratory hold (breath holding)     can decrease the radiation dose that the heart and lung receive for patients being treated     for left sided breast cancer.   "
69201|NCT02379975|"     Some clinical and epidemiological studies have revealed a high prevalence of periodontitis     and tooth loss in patients with rheumatoid arthritis. The aim of this study was to evaluate     the efficacy of periodontal scaling and oral hygiene instruction for patients with mild     chronic periodontitis and rheumatoid arthritis through clinical periodontal parameters and     laboratory tests for CRP (C- reactive protein) and ESR (erythrocyte sedimentation rate).   "
69308|NCT02378584|"     This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in     natural or artificial cycle.   "
69392|NCT02377492|"     The goal of the investigators study is to evaluate the effectiveness of paracervical     injection of vasopressin at the time of abdominal myomectomy to decrease blood loss. The     investigators will continue to use intramyometrial vasopressin as this has previously been     shown to be effective. The study will not exceed the safely documented dose of vasopressin.   "
69204|NCT02379936|"     The immediate newborn period is the period of highest morbidity in life. Early signs of     serious disease are often vague and difficult to interpret for the non- specialist. Screening     lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover     only one or two diseases, and are complicated to handle in low resource settings.      In critically ill newborns, organ failure to one or multiple organ systems is frequently seen     due to inadequate circulation to the tissues. Critical disease will cause hypoxia ischemia of     the cells in the affected organs followed by energy deficiency. Independently of the     condition causing the energy deficiency this will start a series of events, which initially     cause a leaking cell membrane leading to that intracellular components, i.e. the enzyme     Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in newborns     suggests that LDH is a clinically interesting early predictor of serious illness and may thus     serve as an important complement to the clinical examination. If the LDH level is elevated     the health care personnel will realize that something is wrong and call for appropriate     measures.      Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and     accurate method. However, this method needs relatively large blood volumes and the delay     between blood sampling and results is rather long, often several hours. In addition LDH is     sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is     detected at the laboratory a new sample will be needed, thus delaying the result even more.     Also, smaller health care facilities rarely have the laboratory equipment needed for the     analysis of LDH.      The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH     analysis called Hilda Neo. LDH is analyzed on an easy-to-use consumable test card together     with an App on an ordinary smartphone (in the planned study, iPhone 4S). The result is     presented within minutes and presence of hemolysis will be simultaneously detected on the     device.      The investigators speculate that the use of such a LDH test could serve as a diagnostic help     for health-care staff in Vietnam in making the decision when to send a potentially sick     newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)   "
69205|NCT02379923|"     The primary objective of this trial is to evaluate confirmation of placement of any guidewire     beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at     least one Asahi series of guidewires and/or Corsair microcatheter were used.      Procedure success will be defined as angiographic visualization of any guidewire in a     position either distal or proximal to the occlusion depending on the route of access and the     absence of in-hospital MACE incorporating the MI Task Force Third Universal Definition of     Myocardial Infarction.   "
69206|NCT02379910|"     This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of     AM1030-CREAM in patients with Atopic Dermatitis.   "
69207|NCT02379897|"     Controversy exists about the role of dietary glycemic index (GI) and fat content and     cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI,     carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein     (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index     values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks,     then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with     calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight     conditions, and in the free-living state for 48 weeks.   "
69208|NCT02379884|"     This is a prospective observational study evaluating all patients requiring mechanical     ventilation. Data will be gathered regarding the events prior to ventilation and the     indication for mechanical ventilation. In-hospital and post-admission outcome will be     monitored.   "
69209|NCT02379871|"     The topic of spinal manipulation (SM) has been a source of increasing research over the past     decade. Research has focused primarily upon the functional and clinical outcomes associated     with SM. The physiological mechanisms underlying the clinical changes experienced following     SM are still largely unknown. Current thought suggests that SM may have an effect upon the     neurophysiological system, specifically the autonomic nervous system. The purpose of this     study will be to explore the effects of SM upon the autonomically regulated cardiovagal     response.   "
69210|NCT02379858|"     The purpose of this study is to determine whether Alvimopan (Entereg) in ventral hernia     surgery patients is associated with accelerated gastrointestinal recovery and reduced length     of hospital stay compared to placebo controls.   "
69211|NCT02379845|"     RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size     of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and     radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering     surgery more feasible or easier and achieve better local control of the tumor.      PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active     controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the     extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor     injection, activated by external beam radiation therapy or external beam radiation therapy     alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery     will be performed in all patients.   "
69212|NCT02379832|"     Preeclampsia may have several causes leading to different characteristics of the pathology.     Differentiation between the type of preeclampsia would help to treat patients more     accurately. This project aims to identify early markers that are specific to each type of     preeclampsia (early or late, with or without growth restriction). Through a case-control     study, many data will be collected prospectively (serum markers, ultrasonographic markers,     maternal factors) among nulliparous women with no sign of preeclampsia (as soon as the first     trimester) and nulliparous women with preeclampsia (at diagnosis).   "
69213|NCT02379819|"     This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant     in a group of newly implanted adults.   "
69226|NCT02379650|"     Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases     of RPL are unexplained and have no effective treatment to improve the likelihood of a     pregnancy resulting in a live birth. This leads to significant patient and provider     frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in     pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus     erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has     anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in     couples with unexplained RPL. Although some providers are already prescribing HCQ for     unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy     and safety of this treatment. This study has the potential to establish support for a new     treatment option for unexplained RPL.   "
69227|NCT02379637|"     This study is designed to improve knowledge regarding the initial effectiveness of     N-acetylcysteine (NAC) on cold and cough symptoms.   "
70061|NCT02368756|"     The Endurance 2 Trial is to determine the need for ongoing intravitreal aflibercept     injections for patients with diabetic macular edema who have previously completed the VISTA     study.   "
69214|NCT02379806|"     Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every     year. Admission to hospital is one of the main risk factors for VTE, and could account for up     to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce     VTE global burden.      The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight     heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the     latter accounting for the vast majority of events.      Publication of these trials led to the implementation of thromboprophylaxis policies in     hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis     has been challenged after the publication of 1) a negative trial that used 'death from any     cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the     risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the     last version of the American College of Chest Physicians Guidelines, focusing on symptomatic     events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B     recommendation, restricting its use to patients 'at increased risk of thrombosis' and     recommending against the use of thromboprophylaxis in patients at low risk of thrombosis,     patients bleeding or at high risk of bleeding.      However, a limitation of this interpretation of the data is that in most trials, patients     with screened asymptomatic events were treated with anticoagulants, preventing the occurrence     of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly     patients were at high risk of thrombosis in these trials, and that LMWH could be particularly     efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher     than in younger patients and the current trials were not powered to detect a difference in     the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE     is more challenging in the elderly. Therefore, we planned a randomized controlled trial on     the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.   "
69215|NCT02379793|"     The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and     Liquid Paraffin in healthy Japanese male subjects.   "
69216|NCT02379780|"     The investigators aimed to compare the effects of perioperative anesthesia consumption of     ultrasound guided subcostal transversus abdominis plane and paravertebral block in     laparoscopic cholecystectomy.   "
69217|NCT02379767|"     This study aims at evaluating the effect of electroconvulsive therapy in treatment-resistant     depressed patients on the major serotonin degrading enzyme in the human brain using     neuroimaging methods, the monoamine oxidase A. Electroconvulsive therapy is an effective     treatment option in severe cases of depression. However, the mechanisms underlying its effect     remain uncertain, though variations within the serotonergic neurotransmitter system seem to     be crucially involved.   "
69218|NCT02379754|"     The purpose of the study is to determine whether vestibular and postural compensation     following schwannoma surgery is improved by ablating remaining vestibular function prior to     surgery, through gentamicin injections in the middle ear.   "
69219|NCT02379741|"     The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal     IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated     injections directly into the tumor tissue) or intravenously (as repeated doses directly into     a vein) in patients with advanced solid tumors.   "
69220|NCT02379728|"     Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low     birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.      Sleeping on the back during pregnancy has recently emerged in scientific literature as a     potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate     this link was conducted in Ghana by investigators on this protocol.      When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of     the major veins that delivers blood back to her heart and may completely obstruct it. This     may result in less blood being returned to her heart and less blood being pumped to her     developing fetus. Such changes may negatively impact the growth of her fetus and, along with     some other risk factors, may contribute to the death of her baby.      The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount of     time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple,     safe, effective, and well-established modality called positional therapy.      The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and     assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their     home setting via an antenatal care clinic and local health-care staff. Data from this study     will be used in effect size calculations for the design of a large-scale, epidemiological     study targeted at reducing LBW and SB in Ghana and globally.   "
69221|NCT02379715|"     Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence     from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia     (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to     adult or children, so there were many studies about reducing the airway reflex combined with     desflurane.      Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in     the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for     reducing airway reflex or cardiovascular response for intubation combined with desflurane.     But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this     point could be a limitation because desflurane concentration over 1 MAC increase airway     irritation significantly. This study this study was designed to determine a median effective     effect-site concentration (EC50) of remifentanil to prevent airway irritation during     desflurane anesthesia over 1 MAC.   "
69222|NCT02379702|"     Following the first study conducted to investigate the prevalence of metabolic syndrome and     its components in Turkey, it was aimed to demonstrate the change in general health condition     of available patients after the period of time lapsed. This study will provide important     information on the social and economic dimensions of metabolic syndrome and will contribute     to development of preventive programs.   "
69223|NCT02379689|"     Dr. Parker (the Investigator) and Semmes Murphey Foundation (Foundation) are conducting a     study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic,     P.C. (Semmes-Murphey). This study will look at a product that is derived from human tissue,     that will be injected into the affected disc. With this study, the investigators hope to find     a safe and effective way to treat degenerative disc disease.   "
69224|NCT02379676|"     The purpose of this study is to compare the effects of ticagrelor and clopidogrel on     endothelial dysfunction and vascular inflammation      Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with     clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary     intervention (PCI) for non-ST-segment acute coronary syndrome (NSTE-ACS) beyond 1 month after     the index event. Ticagrelor treatment will improve percent flow-mediated dilation (FMD)     values and reduces inflammatory gene expression on peripheral blood mononuclear cells.   "
69225|NCT02379663|"     This prospective study compares an oral direct factor Xa inhibitor with LMWH for     thromboprophylaxis in the patients undergoing THA.   "
69229|NCT02379611|"     Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted     profound congenital deaf infant would be different to the development of a normally hearing     infant.      At 24 months of age, the neurologic development of TVA of deaf infant implanted before the     age of 18 months would be similar to the development of a normally hearing infant.      Main aim The main aim of the research is to study, by means of functional near infrared     spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1 month)     in a group (n=40) of normally hearing infant and in a group (n=40) of profound congenital     deaf children implanted before the age of 18 months.      Main outcome Measure and localization of an increase of brain blood flow during an auditory     stimulation voice type compared to a stimulation non-voice type. Comparison of the     results between groups at 24 months of age +/- 1 month allows to analyse eventual     differences.      Secondary aims and outcomes To study by means of functional near infrared spectroscopy the     neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a     group of normally hearing infant and in a group of profound congenital deaf infant wearing a     standard hearing device between the age of 11 and 13 months and who will receive a cochlear     implant between 12 and 18 months of age.      To study the association between fNIRS data and clinical data of the evaluation of     comprehension of the spoken language at 24 months of age.      Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months old     children will be included during a medical consultation in the ENT department of Necker     hospital after complete information of both parents. Written consent of both parents will be     required. An audiophonological checking will be done.      Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital and     done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). This fNIRS examination     measures the modifications in brain blood flow during the listening of human voice sound and     environmental sound.   "
69230|NCT02379598|"     Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In     industrialized countries there is an incidence of 2-3% in children younger than 2 years.     Cow's milk allergy may present with different clinical pictures and symptoms often     nonspecific. Among the most common are certainly food refusal and failure to thrive until     frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a     negative impact on the quality of life of the patient and his family.      The treatment of this condition provides the setting of a diet that is free of the allergen     to the base of the adverse reaction.      There are some types of formulas for the treatment of this condition. The formulas based on     amino acids are currently used in all cases non-responsive to treatment with the above     formulas or in all those characterized by severe allergic reactions. Being made from amino     acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid     resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead     to a rapid improvement in the quality of life of the patient and his family. However, the     studies currently available to us concerning the effects of nutritional formulas based on     amino acids affect short observation periods (usually less than 6 months) and were directed     to a comparison only with hydrolysates of whey protein or casein and not with healthy     subjects. To date thus lack consistent data on the nutritional effects in the medium to long     term.   "
69231|NCT02379585|"     This study is to see how safe the use of short-term fasting is in breast cancer patients who     will receive chemotherapy before undergoing surgery and to examine if the use of short-term     fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while     receiving chemotherapy.   "
69232|NCT02379572|"     Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by     concomitant chemoradiation. The extent of resection is one of the most important prognostic     factors with significant influence on the survival of patients. State of the art technique to     achieve the most radical resection possible in conventional surgery is fluorescence-guidance     with 5-aminolevulinic acid (5-ALA). If available, intraoperative MRI (iMRI)-guided tumor     resection enables an intraoperative resection control and subsequent continuation of surgery     if contrast enhancing tumor remnants are found. Therefore a more radical resection and longer     survival of patients might be possible. To date no comparison of these two leading     technologies for GBM-surgery is available to identify the best surgical therapy of this fatal     disease and to justify significant healthcare-economic differences between both technologies.      Goal of this study is to assess the value of iMRI guidance in the resection of GBMs in     comparison to conventional 5-ALA microsurgery. Primary endpoint is the number of total     resections (no residual contrast enhancement) in the postoperative MRI (T1+CM within 48 hours     after surgery) in each group. Secondary endpoints are perioperative clinical data,     progression free survival, patients' clinical condition and overall survival.      The study design was chosen to be a parallel-group approach to compare iMRI and 5-ALA centers     (n=13) to exclude possible bias which might be found by randomizing patients within     individual iMRI centers and to have surgeons with the most experience possible in use of each     respective technology.   "
69233|NCT02379559|"     The main purpose of this study is to examine the feasibility of an exercise intervention on     metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men     with MetS who are at increased risk of prostate cancer.   "
69234|NCT02379546|"     This study was designed to determine the effect of the depth of anesthesia on the     oculocardiac reflex (OCR) during pediatric strabismus surgery.   "
69235|NCT02379533|"     Patients will be randomly assigned to perform the training program in center or home-based .     The training program will be conducted in accordance with the recommendations of the American     College of Sports Medicine. All training sessions will be preceded by stretching of large     muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes).     The program will consist of 24 weeks with three sessions per week on alternate days. The     aerobic training will be continuous, with an increment of 10 minutes in duration every 4     weeks. The intensity will be prescribed according to ventilatory threshold, characterized by     the highest intensity of physical exertion fully maintained by aerobic energy pathways. The     intensity control was done by means of the heart rate value obtained at ventilatory     threshold.      Both groups receive the same intervention. However, a group exercise held in the center on a     treadmill with the direct supervision of a physical education teacher. The other group will     exercise at home with telephone follow-up weekly and once a month will be held at the     training center under the supervision of a physical education teacher.      It will also constituted a control group remain without performing any activity during the     study period. After 24 weeks patients receive the same advice the team conducting the     training at home.   "
69286|NCT02378870|"     This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study     evaluating efficacy and tolerability of Osteodex of patients with metastatic castration     resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known     substances; dextran, alendronate and guanidine.      The objective of the study is to evaluate the relative change of response markers to bone     metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall     survival, PSA response, other response markers related to bone metabolism (S-CTX and     osteocalcin), safety, tolerability, pain and quality of life.   "
69236|NCT02379520|"     Subjects have a type of cancer that has been associated with an infection with a virus called     human papilloma virus (HPV). The cancer has come back, has not gone away after standard     treatment or the subject cannot receive standard treatment.      This is a research study using special immune system cells called HPVST cells, a new     experimental treatment.      Investigators want to find out if they can use this type of treatment in patients with     HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the     blood of patients with HPV-cancers. They want to see if these special white blood cells,     called HPVST cells, that will have been trained to kill HPV infected cells can survive in the     blood and affect the tumor. They will also see if they can make the T cells more active     against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that     these HPV-cancers produce. They will grow these HPVST cells from the patient's blood.      The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long     they last in the body, to learn what the side effects are and to see if the HPVSTs will help     people with HPV associated cancers.      If the treatment with HPVST cells alone proves safe (Group A), additional group of patients     (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment.     Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved     for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion     will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby     giving them room to expand. The purpose of this part of the study is to find out if TGF-beta     resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body     and if they are more effective than HPVST cells alone in controlling the tumor.   "
69237|NCT02379507|"     This open-label, adaptive design study was designed to determine the efficacy of the study     product in the treatment of eczema which would be assessed by the reduction of the appearance     of skin lesions and symptoms associated such as itching, scaling and redness.   "
69238|NCT02379494|"     To evaluate the feasibility of screening for preeclampsia and fetal growth restriction     between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler,     maternal blood pressure, maternal characteristics, placental volume, and maternal serum     factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.   "
69239|NCT02379481|"     This study aims to elucidate the effects of deer bone extract NS on cognitive function     improvement and its safety in healthy adults aged 40 to 65 years who report decline in     subjective cognitive functions using multimodal neuroimaging and neurocognitive assessments.   "
69240|NCT02379468|"     The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the     healing of foot ulceration in diabetic patients.   "
69241|NCT02379455|"     Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related     problems, and several studies indicate that inappropriate drug use is a major reason for poor     health and impaired function in the elderly. A majority of interventions for improvement of     drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as     drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate     prescriptions - and it is so far unclear whether such interventions can result in clinical     significant improvements. The primary objective of this trial is therefore to evaluate the     effect upon patients, relatives and local health care service of a structured cooperation     between a hospital-based geriatrician and family physicians on complex drug regimens in     home-dwelling frail elderly patients.   "
69243|NCT02379429|"     Background:      Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better     understand what changes in a person s cells and genes cause this cancer to form. This may     help them find new ways to treat it.      Objective:      - To perform DNA sequencing to help researchers learn the differences between normal tissue     and tumor tissue. Also, to learn how molecular changes - including gene changes - might help     predict the course of disease and how people respond to therapy.      Eligibility:      - Adults age 18 and older who have or are suspected of having urothelial cancer or an     inherited disorder that raises their risk of getting bladder cancer.      Design:        -  Participants will be screened with a physical exam. Their medical records and tissue          samples will be reviewed.        -  Eligible participants will give tissue blocks of their original tumor. The blocks will          be put in a tissue bank.        -  Participants medical records may be reviewed.        -  Participants may have a medical history and physical exam.        -  Participants may have blood and urine tests. They may have imaging scans. They may give          urine, blood, and saliva samples. These samples may be used in future research.        -  If participants need surgery for their cancer, researchers will keep some of the tissue          (both tumor and normal tissue). The tissue may be used in future research.        -  Participants will go back to the Clinical Center in 6 months. They may give saliva,          urine, and blood samples. After 6 months, they will be seen by their local doctor for          standard post-surgical visits.        -  Participants will be called every 6 months to give health updates.   "
69282|NCT02378922|"     This clinical trial studies gene-modified, human immunodeficiency virus (HIV)-protected stem     cell transplant in treating patients with HIV-associated lymphoma. Stem cells, or cells which     help form blood, are collected from the patient and stored. They are treated in the     laboratory to help protect the immune system from HIV. Chemotherapy is given before     transplant to kill lymphoma cells and to make room for new stem cells to grow. Patients then     receive the stem cells that were collected from them before chemotherapy and have been     genetically modified to replace the stem cells killed by the chemotherapy.   "
69244|NCT02379416|"     Background:      - Researchers want to find better ways to treat cancer. One drug that treats cancer is     paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if     another drug, nilotinib, helps paclitaxel work better.      Objective:      - To test the safety of nilotinib plus paclitaxel and find out what doses of the drugs can be     given safely to people.      Eligibility:      - Adults at least 18 years old with advanced cancer that has progressed after receiving     standard treatment, or for which no effective therapy exists.      Design:        -  Participants will be screened with tests they usually get in their cancer care: medical          history, physical exam, blood and urine tests, heart test, and scans.        -  Participants will take the two study drugs in 28-day cycles. They will keep a medicine          diary.        -  Nilotinib will be taken by mouth twice every day except day 1 of the first cycle.        -  Paclitaxel will be given by IV once a week for the first 3 weeks of a cycle. This will          usually be done at the clinic.        -  Most participants will have a weekly study visit every week for cycle 1, then the first          3 weeks of other cycles. They will have:        -  Physical exam at every visit.        -  Blood tests multiple times for cycle 1, then the first 3 weeks of other cycles.        -  Scans every 8 weeks. These may be CT or MRI scans, in a machine that takes pictures. Or          they may be ultrasounds, where a wand is pressed on the skin with gel on it.        -  Around 30 days after stopping the study drugs, participants will be called to discuss          any side effects.   "
69245|NCT02379403|"     Background:      - Heart disease is the leading cause of death and disabilities in the United States. Diets     high in fruits and vegetables may reduce the risk of heart disease. Fruits, including red     tart cherries and purple aroniaberries, may be especially beneficial. Researchers want to     know how tart cherry and aroniaberry extracts affect heart health.      Objective:      - To study the benefits of tart cherry and aroniaberry extract on vascular function and other     measures. These include inflammation, oxidation, and cholesterol.      Eligibility:      - Men and post-menopausal women ages 55 70 in good health and with normal or slightly high     blood pressure or cholesterol.      Design:        -  Participants will be screened with a physical exam, medical history, and blood tests.        -  Participants will have 6 visits. They will have blood taken at every visit.        -  Visit 1:        -  Blood vessel tests. Participants will lie down. Heart rhythm will be monitored. A device          will be placed on the upper arm, and pictures of blood vessels will be taken.        -  A blood pressure cuff will be tightened around the lower arm for 5 minutes.        -  Cardio-Ankle-Vascular Index (CAVI). Blood pressure cuffs will be placed on both arms and          legs. They will be tightened with air at the same time for a few minutes.        -  Participants will be assigned to one of three groups. For 3 weeks each, in random order,          they will take: aroniaberry capsules, tart cherry capsules, placebo capsules, and no          capsules.        -  Participants will answer questions online about their eating and exercise.        -  Participants will be keep a record of what they eat for a few periods. They will come          for a study visit every 3 weeks through week 15.   "
69246|NCT02379390|"     Primary Objective:      To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of     cabazitaxel versus either enzalutamide or abiraterone plus prednisone in patients with     metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while     receiving AR targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months     of treatment initiation (≤12 months).      Secondary Objective:        -  To compare efficacy for:        -  Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).        -  Progression Free Survival (PFS).        -  Overall Survival (OS).        -  Tumor response rate and duration of tumor response.        -  Pain response and time to pain progression.        -  Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE.        -  To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice          variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).        -  To evaluate safety in the 2 treatment arms.   "
69247|NCT02379377|"     This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG)     positron emission tomography (PET) in imaging patients with liver cancer before undergoing     surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and     diagnose liver cancer and find out how far the disease has spread.   "
69248|NCT02379364|"     The aim of the study will be to assess the effectiveness of Diacutaneous Fibrolysis technique     on pain, range of motion (Patellofemoral joint mobility test and muscle length test),     strength and function in patients with Patellofemoral Pain Syndrome and muscle shortening.      Muscle imbalance is one of most important factor associated with Patellofemoral Pain     Syndrome. Shortening of lateral muscles of the thigh have a close relationship with patella     position and tracking and patellofemoral pain. The scientific evidence for effectiveness of     any soft tissue mobilization technique in patellofemoral pain syndrome patients is poor.      Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique to release adherences     and fibrosis between the different musculoskeletal structures. Diacutaneous Fibrolysis is     applied by a set of metallic hooks having the advantage of allowing a deeper and more precise     application, which could not be achieved manually.      The present study evaluates the effectiveness of Diacutaneous Fibrolysis technique applied in     the soft tissues more related with patellofemoral pain.   "
69249|NCT02379351|"     Non-stress tests (NSTs) are used to monitor the health of babies during pregnancy. These     tests are currently conducted in clinics and hospitals. This requires travel to a clinic or     hospital, sometimes multiple times per week, in order to receive these tests. Technology has     been developed that now allows for NSTs to be done in other locations, including home or     work. The Airstrip® Sense4Baby™ NST device has been FDA-approved for use by obstetricians in     clinical and hospital settings. The investigators are evaluating the use of the Airstrip®     Sense4Baby™ NST device in out-of-hospital settings. The investigators would like to know if     this type of monitoring is feasible and acceptable to patients and physicians.   "
69250|NCT02379338|"     In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to     determine the biodistribution, metabolism and excretion of a novel radiotracer     [18F]Fluortriopride ([18F]FTP).   "
70112|NCT02368093|"     Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan     hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic     drugs (DMARDs). Disease activity were assessed.   "
69251|NCT02379325|"     Smoking cessation is a priority for preventing smoking-attributable disease and reducing its     burden. Quitting smoking at any age confers substantial and immediate health benefits,     including reduced risks of stroke, cardiovascular disease and smoking-related cancers, and     quitting smoking by the age of 30 reduces the risk of dying from tobacco-related diseases by     almost 90%. The World Bank suggests that if adult cigarette consumption were to decrease by     half in the year 2020, approximately 180 million tobacco-attributable deaths could be     avoided. Therefore, promotion of smoking cessation has been proposed as a primary focus of     tobacco control efforts, especially in developing countries where smoking prevalence and     cigarette consumption are both still relatively high   "
69252|NCT02379312|"     To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very     low energy aerated beverage with normal energy aerated beverages in healthy subjects.   "
69287|NCT02378857|"     Cross-sectional study of a national cohort of adolescents with univentricular congenital     heart defects and Fontan type palliation.   "
69288|NCT02378844|"     A prospective, double-blind, randomized, sham-controlled, multicentre investigation.   "
69289|NCT02378831|"     The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological     recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG     data, performed by a trained and authorized scorer, according to the AASM (American Academy     of Sleep Medicine) guidelines, serves as a gold standard for all determinations of     efficacy.   "
69253|NCT02379299|"     The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully     automated system for intensive insulin treatment. Such system will ease the burden of     constant treatment decision-making and at the same time it has the potential to safely     intensify insulin therapy such that more patients can reach treatment goals. Currently, no     off-the-shelf closed-loop system exists but research efforts in this field have been     intensified and resulted in great progress in recent years. Most closed-loop systems consist     of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that     continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For     daytime blood glucose control, however, we believe that the system needs to be further     advanced. Consequently, we have extended our single-hormone closed-loop system such that it     now includes a second pump for glucagon delivery and correspondingly we have further     developed our control algorithm to compute both insulin and glucagon dosages.      We hypothesize that we have developed a safe and effective dual-hormone closed-loop system     for patients with type 1 diabetes and that this system is superior to single-hormone     closed-loop therapy. The aims of this two-phase project are to 1) demonstrate     proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose     control.   "
69254|NCT02379286|"     The main objective is to assess the relationships between French teenagers' attitudes and     beliefs towards alcohol and tobacco products and the degree to which they watch and relate to     television series and music videos.   "
69255|NCT02379273|"     This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid     L24 Implant System in a group of already implanted recipients.   "
69256|NCT02379260|"     The aim is to built a Therapeutic Education Program for patients treated with radical     prostatectomy in order to improve their sexuality.      This study is carried out in two steps :        -  Identification of specific educational objectives through a sociological study, with          interviews and focus groups conducted and analyzed by a sociologist. Patients from the          urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL)          will be included        -  Development of the program by a caregiver education expert (Centre Hygée), adapted          partly from results of the qualitative study and partly from concepts and tools from the          Education Sciences.   "
69257|NCT02379247|"     Investigate the use of BYL719 as combination therapy with Nab-Paclitaxel in locally recurrent     or metastatic HER-2 negative breast cancer.   "
69258|NCT02379234|"     Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy     in intensive care units for patients with acute renal failure. In theory, this therapy should     be continuous, 24 hours/day.      However, it is wellknown that actual duration of CVVH sessions is much lower than scheduled,     with frequent circuit down-times (between 1 to 6 hours/day). There are many reasons for     premature ending of CVVH sessions (i.e. catheter dysfunction, wrong settings, low     anticoagulation…), but early detection of any dysfunction may prevent (at least in part) the     CVVH circuit coagulation. ICU Nurses are on the first line to manage CVVH sessions,     particularly in case of alarms.      High-fidelity simulation has been recently proposed for health care provider education. It     has been consistently associated with large effects for outcomes of knowledge, skills, and     behaviors but with moderate effects for patient related outcomes. Indeed, few studies have     assess the impact of simulation on patient outcome following complexe procedures, that     implies team work in addition to individual skills.      In our 12-bed surgical ICU, investigators have decided to implement CVVH technics (in     addition to the dialysis that we already used). Before implementing this new technic in the     ICU, investigators designed this study in order assess wether a high-fidelity based     ICU-nurses education program would improve the outcome of CVVH sessions, compared to the     conventional education program, proposed by the CVVH manufacturer.   "
69259|NCT02379221|"     The purpose of the study is to compare two modalities of local anesthetic administration     prior to the placement of cosmetic facial injectable fillers. Both short and long term pain     perceptions for the facial filler procedure will be compared in patients receiving 4%     Topicaine gel on half their face and 2% lidocaine 1:100k epinephrine nerve block injections     on the other half of their face. The objective is to quantify the subjective pain experienced     by these two modalities of local anesthetic during the procedure of Juvederm XC filler     injections.   "
69260|NCT02379208|"     The purpose of this study is to evaluate rate of progression in newly diagnosed open angle     glaucoma with different types of perimetry. Would it be possible to find the rapidly     progressing individuals sooner by doing perimetry more often? Is there a difference between     different types of perimetry in early glaucoma? What would be the optimal timing of perimetry     in newly diagnosed glaucoma? In addition the quality of life in glaucoma patients will be     evaluated with two types of questionnaires in three different time points. The enrolled     patients will receive appropriate treatment according to glaucoma management guidelines.   "
69283|NCT02378909|"     Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect     nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense of     touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin     resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged     tissues especially if the patients have diseased blood vessels causing a lack of blood to     areas of the body including the feet (called ischaemia).   "
69284|NCT02378896|"     This study will evaluate the effects of a computerized training program coupled with     cognitive behavioral therapy (CBT) for OCD.   "
69261|NCT02379195|"     Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive     clinical results with durable complete responses in patients with metastatic melanoma. The     TILs are isolated from the patients own tumor tissue followed by in vitro expansion and     activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion     Interleukin-2 are administered to support T cell activation and proliferation in vivo.      In this trial the therapy is combined with peginterferon (the pegylated form of interferon     alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA     expression on melanoma cells and are hypothesized to synergize with TIL therapy.   "
71313|NCT02352311|"     This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study     to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and     tadalafil) in healthy male volunteers.   "
69262|NCT02379182|"     Prospective, randomized, controlled, three-arm, open-label, blinded analysis. Patients     admitted with stroke diagnosis and with suspected dysphagia that meet the initial inclusion     and exclusion criteria will be consented into the clinical investigation. Patients who meet     the second set of inclusion criteria (dysphagia confirmed by VFS) will be randomized to     either active (motor or sensory) or standard treatment (control group) arms.      Subjects included in this clinical investigation will be evaluated at screening, 1-week,     3-months and at 12-months post treatment.      The main aim of the study will be to assess the effect of VitalStim therapy on improving the     safety of swallow according to the VFS, after the treatment and at 1-year follow up, on     patients with chronic post-stroke OD.   "
69263|NCT02379169|"     Low macular pigment optical density has been associated with increased risk of age-related     macular degeneration, an important cause of vision problems in the elderly population. Dry     eye is multifactorial disease of tears and the ocular surface associated with symptoms of     dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The     aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye     health, specifically on the macula.   "
69264|NCT02379156|"     The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons     with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability     of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to     impair mental function in able-bodied (AB) persons, there has been no work to date addressing     these issues in persons with tetraplegia.      Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes     Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a     decrease in cognitive function.      Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of     the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with     tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop     Interference scores (a measure of executive function).      Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate,     and (3) thermal sensitivity.      Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average     distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings     compared with AB controls.      Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine     (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the     decline in cognitive performance in the group with tetraplegia compared to the exact same     procedures performed on the day with no medicine (Visit 1) in that same group.      Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced     decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the     associated decline in cognitive performance compared to the changes in Tcore and cognitive     performance during cool temperature exposure without midodrine in the same group with     tetraplegia.   "
69265|NCT02379143|"     Various national & international bodies like FDA, CSP has laid down the guidelines for the     reasonable use of SWD electro therapeutic agent (EPA) ensuring safety & effectiveness.      However, it remains uncertain, whether the practicing physiotherapists are aware of the very     existence of this guidelines and implementing them in daily practice. Any lack of knowledge     about this background can endanger the patient safety leading to serious health hazards.      In the present survey, 49 physiotherapy practitioners were interviewed with a self-report     measure to investigate their knowledge base, mode of application of SWD (6 items) & the     awareness about recommended guidelines (5 items) etc.   "
69266|NCT02379130|"     The purpose of this study is to determine the effects of Family Nurture Intervention in     preschool aged children between 2.5 and 4.5 years of age who were born prematurely and     exhibit developmental deficits. The new approach is based on improving aspects of maternal     nurturing behaviors as well as mother-child co-regulation, which are important to early     development. Since young children with developmental deficits are often easily upset, mothers     will be taught how to co-regulate with their child through comfort and calming interactions     during 11 clinic visits. Assessments in the follow-up clinic will test the immediate and     long-term effects of this new approach to the nurture of children who were born early and     demonstrate developmental problems and behavioral problems.   "
69267|NCT02379117|"     Food intake is mainly controlled through interactions between the gut and brain (the     homeostatic control) and through our environment, with food exposure, mood and past     experiences (the hedonic control) playing a major role. The link between the gut and the     brain is mainly controlled through enteroendocrine cells (EC). These cells in the bowel sense     nutrients in the food and link with the brain to control how much we eat. They make a number     of hormones that link with the brain to control one's eating habits.      Crohn's disease (CD) is an inflammatory disease of the bowel which can present with a number     of symptoms including weight loss and loss of appetite. We thought some time ago that an     increase in the number and function of these EC could play a central role. Since then we have     carried out work which has shown that in CD these EC increase in number and produce more     hormones after a meal. This finding could have a negative effect on food intake. This would     be one explanation to the symptoms so commonly experienced by these patients.      In CD we thus feel that there might be an imbalance in the appetite control. We expect an     increasingly sensitive gut to food intake and a subdued mood and perception to food reward     and that this imbalance will lead to a decrease in food reward and consequently a decrease in     food intake.      This study will be carried out using Healthy Volunteers and CD patients. We plan to measure     food intake though telephone interviews and plan to analyse eating behaviour through 5     questionnaires.This study will help us to improve our understanding of what it is that     controls food intake. This will be particularly important to patients with CD who routinely     lose weight and appetite.   "
69268|NCT02379104|"     ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is     fully automated allowing for a simple and safe operation compared to its predecessor model     ROTEM® delta.      Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of     equality.      Confirmation of reference intervals of the ROTEM® systems.   "
69269|NCT02379091|"     The purpose of this study is to establish proof of concept and identify the optimal     efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate     (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor     (TNF)-inhibitor (TNF-IR).   "
69290|NCT02378818|"     This research focuses on disorders of motivation, responsible for a disability that patients     experience daily. It is a disorder that affects behavior, especially social. Mechanisms,     which result in these disorders, are poorly understood. This ignorance is responsible for the     lack of effective therapy. The investigators realize this work in order to better understand     the motivational deficits. The objective of the study is to characterize the cognitive     mechanisms of motivational deficits in schizophrenia and depression. To answer the question     posed in the research, it is planned to include 35 people with schizophrenia, 35 people with     depression and 70 heathy volunteers in the Hospital of Sainte-Anne .   "
69270|NCT02379078|"     Diabetes care is complicated for people with diabetes as well as for health care providers:     they have to watch their diet, exercise, take medications, checking blood sugars and blood     pressure, get tests and see multiple doctors. On top of that, many with diabetes have other     health problems, such as high blood pressure or arthritis, that make care even more     complicated. Guidelines for improving the care of people with diabetes try to help by     summarizing the best practices for care, but because diabetes care is so complicated, it is     hard for them to be put into practice. One solution to this is a tool that can help people     with diabetes set health care goals that are important to them, and participate actively in     decisions about their own health care, together with health care providers. This tool would     have an information booklet for patients with facts that can help them make a decision, a     worksheet to help spell out what their goals are and how they want to get there, and a     cheat-sheet for health care providers that gives them tips on how to do this. The purpose of     this project is to find out if a tool like this would be helpful, how to make it more helpful     and usable, and what the best way would be to make sure that people use it.      An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including a     1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented     successfully in clinical practice and will reduce decisional conflict and diabetes distress     and improve chronic care delivery and quality of life in patients with type 1 or type 2     diabetes and 2 other comorbid chronic diseases. The investigators hypothesize that patients     in the intervention arm of the study will have reduced decisional conflict and diabetes     distress, and improved decision-making satisfaction, chronic care delivery and quality of     life.   "
69271|NCT02379065|"     The investigators are looking at whether a new type of nebuliser (a machine used to deliver     drugs to the airways) is better at delivering drugs to the lungs of people with Chronic     Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency     Departments. The investigators will randomly allocate patients who come into the Emergency     Department with an acute episode of the COPD into either the standard nebuliser group or the     new nebuliser group.      Both groups will receive the same medications, it is only the method of delivering them which     will be different.   "
69272|NCT02379052|"     The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous     (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult patients with     active, moderate to severe eosinophilic esophagitis (EoE). The study comprises 2 sections     with double-blinded, randomized, placebo-controlled study and an open label extension (OLE)     to evaluate long-term safety.   "
69273|NCT02379039|"     The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy     response of squamous cell carcinomas, in an early treatment phase.   "
69274|NCT02379026|"     This study evaluates the addition of a high-protein energy-restricted diet to exercise in the     treatment of sarcopenic obesity in people aged 65 and over. Half of participants will follow     a hypocaloric (500 kcal deficit) high-protein (1.2 -1.5 g Protein/ kg bodyweight) diet     alongside an exercise regime, while the other half will follow the same exercise regime     alongside their habitual diet . All participants will consume a Vitamin D3 tablet     (25micrograms) 3 times a week to achieve a weekly intake of 75 micrograms. Total duration of     the intervention will be 16 weeks.   "
69275|NCT02379013|"     The purpose of this study is to determine more objective, central and peripheral indices of     fatigue state by exploring the neural and behavioral correlates of the alert process while     keeping the idea to corroborate these results with those obtained during the performance of     physical exercises and neuropsychological tests classics of attention, motivation, and     functions evaluation. The interest of this study is to manipulate and compare the phasic and     tonic alert mechanism through the activation of an extrinsic motivational system during     fatigue. The investigators have chosen the alert since it is a basic cognitive process     defined as the ability to increase attentional resources with the expectation of a target     stimulus resulting in reduced response time. It can be phasic (extrinsic), favored by the     presence of a warning signal preceding the target (preparation time) or tonic (intrinsic)     occurring without warning signal (wakefulness). The evaluation of the alert is classically     realized by a simple reaction time task with the presence or not of warning signal soliciting     wether the tonic alert or the phasic alert.      The investigators suppose to revisit the healthy population with brain model alert issued in     2010 which highlighted the predominant role of the regions of the dorsolateral prefrontal     cortex, parietal, cingulate and thalamus (non-motor) in maintaining attention and temporal     preparation alert task.      The investigators identify also functional, motor and cognitive components of basal ganglia     of thalamus. Cognitive-motor paradigm and neurological dysfunctions observed in multiple     sclerosis population will help to identify and separate the cognitive role and motor brain     regions, particularly the thalamus and basal ganglia. New neurological hypotheses are     proposed   "
69276|NCT02379000|"     Proton beam therapy is a safe irradiation modality for choroidal melanoma. But often after     irradiation the exudation increases resulting in an exudative retinal detachment requiring     vitreoretinal surgery. It is known that intravitreally injected triamcinolone and TTT is     capable to decrease the exudation. If there is any advantage in a combined treatment this     study will investigate.   "
69277|NCT02378987|"     The aims of this study:        1. to investigate the difference in motor speech functions among children with cerebral          palsy (CP) of different motor severities.        2. to investigate the longitudinal in motor speech functions at 6 months follow-up phase          among children with CP of different motor severities.        3. the correlation between motor severity, personal factors, family factors, language          ability and motor speech in children with CP.        4. to identify the variables that can predict motor speech functions in children with CP.   "
69278|NCT02378974|"     The objective of the study is to evaluate the safety and the potential therapeutic effects     per dose of Cordstem-ST Intravenous Transplantation in Cerebral Infarction subjects comprised     of 2 treatment cohorts:      Cohort 1 : Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0      Cohort 2: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7   "
69279|NCT02378961|"     This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir     (SOF)/velpatasvir (VEL) fixed dose combination (FDC) in adults with chronic non genotype 1     hepatitis C virus (HCV) infection.   "
69280|NCT02378948|"     The aim of this study is to investigate the effects of early start versus delayed start of     oral intake on postoperative functional recovery after an esophagectomy.   "
69281|NCT02378935|"     This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir     (SOF)/velpatasvir (VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic     genotype 1 hepatitis C virus (HCV) infection.   "
69285|NCT02378883|"     The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Micro     Catheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous     malformation (AVM) embolization procedures.   "
69293|NCT02378779|"     Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59     have admitted suffering from a decrease in, or loss of control of, their ejaculation. The     quality of life of patients and their partners is impaired compared to men not suffering from     premature ejaculation. Economically, the impact of the disease are significant. In the year     preceding the detection of premature ejaculation patients visit twice their physician. The     majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting     room, considered it important to talk with their GP about their sexual concerns. Almost half     of them preferred that their GP initiate any discussions about sexuality. More than two     thirds of the respondents would have liked their GP to signal his or her open-mindedness by     directly addressing sexual topics during the consultation. In 2008 a qualitative study     brought to the fore the strategies used by GPs to initiate the discussion on premature     ejaculation . GPs who mentioned premature ejaculation with their patient described three     attitude-related strategies and three investigative strategies.   "
69294|NCT02378766|"     The purpose of this study is to evaluate the efficacy of a web-based tailored intervention to     support persons living with HIV (PLHIV) manage the demands inherent to their health     condition, particularly as regards to the adoption of health behaviours such as being     physically active, following a healthy diet and quitting smoking.      This randomized controlled trial is currently conducted entirely online at     www.lhivehealthy.ca   "
69295|NCT02378753|"     The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread     and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood     and secretions, lack of appropriate personal protective equipment (PPE) and challenges in     following infection control and prevention protocols put healthcare workers at high risk     during outbreaks, and direct contact with the bodies of deceased Ebola victims can also     sustain community transmission. This study will accelerate introduction and use of monovalent     recombinant vesicular stomatitis virus Ebola vaccine (rVSVΔG-ZEBOV) among healthcare workers     and frontline personnel involved in the Ebola outbreak response in Sierra Leone, while     concurrently evaluating the safety and efficacy of the vaccine.      This is an unblinded, randomized trial with phased vaccine introduction in the target     population. Participation in the study will be voluntary and open to adults 18 years of age     and older who are at high risk of exposure to Ebola infection through their daily work and     who work in a selected study area.   "
69296|NCT02378740|"     Ketamine is an IV anesthetic with non-opioid analgesic properties that has been shown to     reduce pain while also decreasing intraoperative and postoperative opioid requirements when     used in subanesthetic doses after a variety of surgical procedures.1 It is a non-competitive     antagonist of N-methyl-D-aspartate (NMDA) receptors, and by this mechanism ketamine is     believed to block the development of central sensitization and wind-up phenomenon,2,3 which     may be helpful in preventing acute and chronic pain after repetitive insults. In a systematic     review of ketamine as an adjuvant to opioid analgesia, low-dose ketamine was found to be a     useful addition to standard postoperative pain management practice with opioids in 54% of     studies.1 The studies that did not show a significant effect were in patient populations with     low opioid requirements. Therefore, it has been suggested that future clinical trials be     focused on patient populations with significant post-operative pain, such as spine surgery     and major orthopedic surgery not amenable to regional analgesia, and postoperative pain in     patients on chronic preoperative opioid therapy.1      There are few studies examining outcomes after ketamine in the perioperative period after     spine surgery. Loftus et al randomized patients with a history of chronic preoperative opioid     use (i.e., daily opiate use for at least 6 weeks) to intraoperative ketamine versus placebo     and found a 30% reduction in morphine consumption at 48 hours and an approximately 25%     reduction in visual analog scale (VAS) pain score in the post anesthesia care unit and at 6     weeks.4 Although this study provided evidence that there may be reduction in long-term     postoperative pain, additional studies are needed to provide evidence that this effect is     sustained beyond the 6-week period.      We are interested in examining ketamine more closely in spine surgery because this patient     population experiences significant postoperative pain that may be difficult to control due to     preoperative opioid use (i.e., opioid tolerance). The investigators chose to study ACDF     patients specifically because it is a common spine procedure throughout the United States and     the patients have significant opioid requirements postoperatively. In a study examining the     effects of the low dose ketamine for postoperative IV PCA fentanyl after cervical and lumbar     surgery, patients in the placebo group (and thus only receiving fentanyl PCA) reported mean     VAS scores of 4-5 with movement while receiving opioids.5      Further, while previous studies have shown an opioid-sparing effect of ketamine as measured     by opioid consumption and a decrease in pain as measured by VAS scores, no study to our     knowledge has examined quality of recovery after intraoperative ketamine infusion. The     Quality of recovery (QoR-40) score was developed by Myles et al to assess quality of recovery     after anesthesia based on forty questions in five dimensions,6 and this score has been shown     to be a reliable and valid outcome for patients undergoing both spine and cranial surgery.7     QoR-40 is also of interest because it should be able to provide a global assessment of the     possible benefit or harm of using ketamine in patients by simultaneously characterizing the     detrimental side effects as well as the positive benefits of ketamine when used as an     infusion at subanesthetic levels (studies thus far have shown that there are minimal side     effects such as hallucinations).1,4      Significance:      Previous studies have shown an opioid-sparing effect of ketamine, however further research is     warranted in patients whose pain may be difficult to control and whether this effect is     sustained. ACDF patients experience significant pain post-operatively, and ketamine may     improve their quality of recovery due to its opioid-sparing effects and prevention of chronic     pain. Further, patient centered outcomes as measured by the QoR-40 have not been reported in     the literature when ketamine, or other opioid sparing anesthetics, have been administered.     This study will not only determine if the moderate dose of ketamine is beneficial or     detrimental to the recovery of patients but also whether it can improve long term patient     function, presumably by decreasing central pain sensitization. In addition, this study will     set the stage for further RCT's examining other analgesic strategies in cervical spine     surgery patients (i.e., intraoperative lidocaine infusions, volatile anesthetic vs. propofol     as the primary hypnotic, COX-2 inhibitors, pregabalin, etc.). The overall goal would be to     develop a multi-faceted regimen that decreases the postoperative inpatient opioid     requirements of these patients and may facilitate long term recovery.      The research questions:Does ketamine improve the quality of recovery at 24 hours after     anterior cervical discectomy and fusion (ACDF)? The hypothesis: the investigators hypothesize     that ketamine will improve the quality of recovery after ACDF surgery   "
69297|NCT02378727|"     The purpose of this pivotal study is to demonstrate safety and effectiveness of the CompuFlo®     Epidural Computer Controlled System (referred to hereafter as CompuFlo® Epidural) for the     epidural space verification.      The CompuFlo® Epidural System is limited by federal law for investigational use only in     United States of America and has received CE mark in European Union.   "
69298|NCT02378714|"     Persons who struggle with depression smoke at high rates and experience low quit rates in     treatment. The best way to improve cessation treatment for this underserved population     remains unknown. The proposed trial tests whether the combination of varenicline and     behavioral mood management treatment enhances long-term abstinence for depressed smokers and,     if so, whether this treatment achieves its effects through addressing the unique     psychological factors that appear to maintain tobacco dependence for these smokers.   "
69299|NCT02378701|"     The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in     patients with MDS.   "
69300|NCT02378688|"     The primary objectives of the study are:        -  To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe          active Crohn's Disease（CD）        -  To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active          CD.   "
69315|NCT02378493|"     This is an observational study that does not change routine care.      The primary objective of this study is to investigate the role of     antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed     antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of     antibiotics.   "
69301|NCT02378675|"     Apelin, Visfatin, Omentin and Resistin are adipocytokines derived from human adipose tissue     as well as placental tissue and have been shown to be potential mediators of insulin     resistance. In each pregnancy, a physiological Insulin resistance syndrome occurs to ensure     that the fetus is sufficiently supplied with glucose. Due to their impact on glucose     transport mechanisms adipocytokines play an important role for the development of insulin     resistance.      Gestational diabetes mellitus (GDM) is one of the most common pregnancy - associated diseases     with a prevalence of 5-10% of all pregnancies and its prevalence is increasing. It is     associated with severe hazards to both mother and fetus such as macrosomia, plexus palsy,     premature delivery and intrauterine death. Furthermore, up to 50% of women with GDM develop     Type 2 Diabetes Mellitus (DM2) within the following ten years after pregnancy. GDM seems to     be a potent risk factor for the development of DM2 in later life by sharing a number of     epidemiological, physiological and genetic characteristics with DM2. Therefore, alterations     in adipocytokine levels in women with GDM, if present, may resemble those observed with DM2.      Furthermore, the exact pathogenesis of GDM is not completely understood, however, increased     insulin resistance is a well demonstrated mechanism.      Adipocytokines are known to alter insulin resistance through several mechanisms described in     the literature. The investigators therefore expect a possible relationship between the above     described adipocytokines and gestational diabetes mellitus.      Results of the HAPO-Study have shown a significant association between fetal outcome and mean     blood glucose levels in women suffering from GDM. The HAPO Study group supposed a possible     relationship between GDM and fetal insulin levels and used C-Peptide to quantify fetal     hyperinsulinemia.      A recent study suggests that not only hyperglycemia but also altered maternal lipid     metabolism may constitute a risk factor for macrosomia in GDM.      In summary, the investigators aim to illuminate a possible association between the     adipocytokines Apelin, Omentin, Resistin and Visfatin, lipid metabolism and gestational     diabetes mellitus.   "
69302|NCT02378662|"     The objectives of this study are to assess safety and to evaluate the biologic activity of     TARGTEPO treatment in Peritoneal Dialysis patients   "
69303|NCT02378649|"     A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and     safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in     patients with pre-operative Significant Pulmonary Hypertension.   "
69304|NCT02378636|"     This will be a prospective, open-label, 125 subject (maximum), two-year multicentre     investigation to assess the safety, effectiveness and rotational stability of the modified     600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.   "
69305|NCT02378623|"     Patients with a patent foramen ovale in the setting of endocardially placed cardiac     implantable electronic devices such as pacemakers, defibrillators, or resynchronization     therapies are likely at higher risk for paradoxical embolic events from device lead thrombus.     The investigators are conducting this study to determine if the anticoagulant medication     Apixaban is more effective at reducing MRI detected brain lesions compared to placebo.   "
69309|NCT02378571|"     The overall purpose of this project is to determine the feasibility of conducting a large     scale randomized clinical trial that compares remote monitoring of adherence to loop     diuretics using a wireless electronic pillcap with usual care among recently hospitalized     heart failure patients. The long-term goal of this program of research is to determine the     effect of the adherence telemonitoring intervention on medication adherence and hospital     readmissions among recently hospitalized heart failure patients.   "
69310|NCT02378558|"     This small pilot will allow surgeons to perform wireless breast lumpectomies using a new     magnetic technology. This is a continuation of a previous project testing the technology, and     the breast surgeons comfort level using this new technology.      The aim of this project is to develop a new technique for surgical excision of lesions either     through surgical biopsy or lumpectomy. The current standard of care involves placing a needle     then slender wire through the lesion under image guidance by a radiologist. The surgeon then     removes the lesion using the wire as a guide. This new technique would place a magnet through     the lesion under image guidance by a radiologist. The surgeon would then use the MagneProbe     in the operating room to locate the magnet and remove the lesion. This new technique would     eliminate the use of a wire that protrudes from a patient's breast. This wire is usually     placed on the day of surgery, prior to the procedure. The goal of this new technique is to     eliminate wire placement and increase patient comfort throughout the day of her surgery.   "
69311|NCT02378545|"     The motivation for this study comes from a desire to improve the mortality of patients with     sepsis. Oxygen is cheap, readily available and is included in current United Kingdom     Emergency Department guidelines, but it may also be harmful to patients with sepsis - it is     important to know if this is the case.      This study is a pilot study to also assess the feasibility of delivering a larger adequately     powered study.   "
69312|NCT02378532|"     Patients with a glioblastoma (GBM) have a poor prognosis with a median survival of 14.6     months after maximal treatment with a resection and chemoradiation. Since the pivotal trial     evaluating the effect of temozolomide (TMZ), overall survival has not increased.      Treatment of GBM xenografts in vivo with chloroquine (CQ), an antimalarial agent, has been     shown to reduce the hypoxic fraction and sensitizes tumors to radiation. Epidermal growth     factor receptor (EGFR) amplification or mutation is regularly observed GBM and is thought to     be a major contributor to radioresistance. The most common EGFR mutation in GBM (EGFRvIII) is     present in 50-60% of patients whose tumor shows amplification of EGFR. EGFR provides cells     with a survival advantage through autophagy when exposed to stresses such as hypoxia and     nutrient starvation. This effect is even more pronounced in EGFRvIII overexpressing tumors.     Previously, the potential effect CQ has been demonstrated in a small randomized controlled     trial in GBM treated with radiotherapy and carmustine, which showed a trend towards increased     overall survival. However, as the intracellular effects of chloroquine are dose-dependent the     maximum tolerated dose for CQ in combination with concurrent radiotherapy with daily     temozolomide needs to be established.   "
69313|NCT02378519|"     The aim of the study is to evaluate the effects of a the multimodal treatment with a     web-based self-help program with cognitive behavioral therapy coaching and individual     tailored physiotherapy on workability, health behavior and pain symptoms for persons with     persistent pain.   "
69314|NCT02378506|"     Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the     high capacity process. Descriptive results will be provided however a formal hypothesis will     not be tested in this trial.   "
69320|NCT02378428|"     This is a Phase II study for patients with MIBG avid tumors. The study is to determine the     response rate to <131>I-MIBG in patients with de novo, relapsed or refractory neuroblastoma     or other MIBG avid malignant tumors 42 days post MIBG therapy. It will also be evaluating the     tolerability and safety of the study agent by evaluating the hematopoietic and     non-hematopoietic toxicity of <131>I-MIBG therapy. Tumor response will be evaluated by     comparing the patient's disease pre-treatment against the patient's day +42 post <131>I-MIBG     treatment. The evaluations may include the following: <131>I-MIBG scan, CT or MRI, urine     catecholamine, bone marrow analyses and any other tests considered standard of care for     cancer evaluation. To be eligible for participation, patients must have tumors that are MIBG     avid. Patients must also have a stem cell source for autologous rescue in the event of     protracted therapy associated cytopenias. Peripheral stem cell collections are preferred as     the hematopoietic cell source. Bone marrow harvests for a hematopoietic cell source is an     alternative. This study will provide data for future clinical trials utilizing <131>I-MIBG     therapies. A room on H12 has been prepared with lead lined walls, and many radiation safety     components to accomodate this treatment. <131>I metaiodobenzlguanidine (<131>I-MIBG) is a     radiopharmaceutical that concentrates within adrenomedullary tissue. The agent was initially     used for tumor imaging due to its capability to locate pheochromocytomas, neuroblastomas and     other neuroendocrine tumors. <131>I-MIBG was subsequently used as an therapeutic agent for     these tumor types. Phase I and II therapeutic trials targeting neuroblastoma have reported     response rates of 10-50%. Toxicities observed have been mainly hematopoietic, with ~50% of     patients receiving 15mCi/kg requiring stem cell reinfusion. Observed non-hematopoietic     toxicities have been mild. Most recently, trials have been conducted combining the study     agent with myeloablative chemotherapy and stem cell reinfusion have been performed with     initial response rates of ~50%.   "
69321|NCT02378415|"     The objective of this double-blinded placebo-controlled pilot study is to determine whether a     single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed     patients with or without suicidality has a significant rapid antidepressant effect in the     acutely depressed population. The study will pursue as a primary outcome measure whether a     significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly     after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure     will be assessed to determine whether this single infusion of ketamine has a sustained     reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score.     Suicidal ideation will also be assessed for determination of any reduction and sustained     reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck     Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.   "
69332|NCT02378272|"     The aim of the project is to explore if a complementary addition of a care manager for     depression treatment in the primary care setting has positive effects concerning reduction of     the patients' depressive symptoms as well as improvement of daily function and quality of     life in a short- and long-term perspective compared with the traditional Swedish primary care     organization. The aim is also to evaluate the care manager function in a health economic     perspective.      The specific aims are to develop and evaluate an evidence-based care manager program for     patients with mild to moderate depression and to compare the evidence-based care manager     program to treatment as usual (TAU) in terms of their short- and long-term effects on symptom     remission, treatment adherence, care satisfaction, and self-efficacy as well as to perform a     cost - effectiveness analysis of the care manager program, i.e. to evaluate the effects of     the program on patients' health in relation to the running costs of the program.   "
69322|NCT02378402|"     The objective of this 3-year project is to develop myocardial MRS, in particular lipid     (triglyceride) and creatine resonances, as imaging biomarkers for patients with heart failure     (HF). Investigators will elucidate how and, to what extent, lipid and creatine levels of the     heart contribute to heart failure. The first year is a cross-sectional study. Investigators     aim to compare the MRS of normal subjects and that of stable HF patients in recovery with     normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20     subjects in each group. In the 2nd and 3rd years, investigators plan a prospective     longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac MRS at     three time points, i.e., disease onset, 6 months and one year after treatment, and will be     followed up until the end of this project (1.5~3-year follow up). In total 120 MR scans will     be performed in the 2nd and 3rd years. The resonances from cardiac MRS, including creatine     and lipids, will be correlated with the disease course, patient biochemistry data and     clinical outcome. Investigators expect to make MRS to become an integral part of a clinical     cardiac MR protocol.   "
69323|NCT02378389|"     Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This     study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in     combination with Docetaxel in patients with HER2 positive advanced gastric cancer.   "
69324|NCT02378376|"     During this project the amount of SCFA produced in the colon after consumption of 2 different     13C-labelled wheat fiber fractions will be quantified.   "
69325|NCT02378363|"     The main objective is to develop an educational program and to measure the impact on social     representations identified as acting in the prevention of cancer. Child should write, draw     and speak about cancer signifiance to identify individual conceptions and representations of     health and cancer in children aged 9 to 12 years in school.   "
69326|NCT02378350|"     This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage     renal disease (ESRD) requiring PD or conventional in-center HD treatment.      Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal     dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1 year     of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire     domain of burden of kidney disease.      Secondary Objectives: The secondary objectives are to observe and summarize the following     parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL     instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items,     which will be compared between the 2 treatment groups:        -  Mortality rates        -  Switch (PD to HD or HD to PD)        -  Transplantation rate        -  Cause of death        -  Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the          volume of distribution of urea [Kt/V urea] to determine the proportion of subjects          meeting standards of care for dialysis adequacy).        -  24-hour urine volume        -  Change in hemoglobin and S-phosphate levels, and the percentages of subjects with values          within the target range        -  Change in serum albumin        -  Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory          test findings with clinical significance   "
69327|NCT02378337|"     Identify the best combination of predictive variables that influence ionizing radiation dose     and improved image quality through analysis and quantification of PET-CT images in simulators     and patients.   "
69328|NCT02378324|"     Several reasons can explain non-attendance in cervical cancer screening. In low resource     settings the attendance is even lower. The effect of fee as contributing reason of non     attendance has not been studied before why the investigators decided to study this in a low     resource setting as a randomised trial.   "
69337|NCT02378207|"     The aims of the phase 1b trial described here are to facilitate identification of assays and     immune responses that could then be evaluated as correlates of risk and correlates of     protection in efficacy studies and ultimately to provide leads for biomarkers of protection     against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating     the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).   "
70113|NCT02368080|"     This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults     obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each     participants will perform the test (LCI) in duplicate on each device.   "
69329|NCT02378311|"     Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle     injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60     years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of     those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major     paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor     falls; they are not unique to riders performing stunts[5].      One small study found that the metal handlebar ends were often exposed on bikes of children     sustaining severe abdominal injuries[6]. Most European safety standards do not test grip     durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal     handlebar tube.      This feasibility study aims to test the research methods that will be used in a subsequent     nationwide multicentre study. The main study will investigate the association between     injuries and handlebar grip condition.      Children attending study hospitals with any bicycle or kick scooter injury will be invited to     participate. Parents of injured children will be invited to complete questionnaires regarding     circumstances surrounding the injury and condition of the handlebar ends on the bike or     scooter involved. Clinical information regarding the injury will also be collected. The     handlebar end condition will be compared between children sustaining a handlebar end injury     [Cases] and riders whose injury did not involve the handlebar [Controls].      If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries,     injury prevention strategies can focus on methods to prevent damage occurring to grips     through day-to-day use. If no such association is found, prevention strategies can be focused     elsewhere, such as on design of effective protective clothing.      Data collection for this feasibility study will occur between March 2015 and September 2015.      The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.   "
69330|NCT02378298|"     Thyroid Associated Ophthalmopathy is condition affecting the eyes of about 10% of patients     with Graves disease. Its combination of protrusion affecting the looks of the patient and     pain is often severely affecting the quality of life among these patients.      The standard treatment for this illness today is intravenous glucocorticoids together with     methotrexate. The purpose of this study is to evaluate the effect of rituximab on patients     that do not respond to or relapse after conventional therapy.   "
69331|NCT02378285|"     The purpose of this study is to assess efficacy of two intra-tendinous injections of     platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared     compared to two intra-tendinous injections of saline solution (placebo).   "
71353|NCT02351791|"     The primary purpose of the study is to investigate the impact that feces mixtures have on the     peristomal skin when using a standard adhesive.   "
69333|NCT02378259|"     Severe childhood obesity is associated with both immediate and chronic health problems and a     severe impact on psychosocial development. Medical and behavioural interventions rarely     result in the significant, durable weight loss necessary to improve health outcomes.      This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be     randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense     conservative treatment and possibly surgery as they have become 18 years.   "
69334|NCT02378246|"     THE ULTIMATE GOAL of this project is to answer the question In MILD IODINE DEFICIENCY (ID),     should 150 μg iodine/day be administered to pregnant women with a normal diet, to attain a     normal cognitive development of the fetus or is there no cognitive deficit from mild ID and     no extra iodine is needed?. To answer this question, the investigators planned a randomized,     placebo-controlled trial of iodine supplementation during pregnancy in Sweden (SWIDDICH) with     the follow-up of childrens' COGNITIVE DEVELOPMENT at 18 months, 3.5, 7 and 14 years.      Iodine deficiency (ID) is associated with thyroid morbidity and, especially in children, with     impaired cognitive development. Sweden introduced iodine fortification of table salt 1936 and     mental retardation due to severe ID is eradicated. Is mild ID during pregnancy also     eradicated? If not, is this of importance? A national study performed by the investigators in     2007 showed iodine sufficiency in general population, but there are no pregnancy data. Local     studies have raised concerns for mild ID during pregnancy in Sweden and a trans-sectional     national study is currently ongoing.      The burning question for Sweden and the whole world is: is mild ID during pregnancy of     importance for the developing brain of the fetus? Two large observational studies have shown     association between mild ID during pregnancy and lower verbal IQ or educational performance     at school-aged children. The world needs a randomized placebo-controlled trial (RTC)     comparing the cognitive outcome in children exposed to mild ID during fetal life with     children exposed to normal iodine levels during fetal life.      Our HYPOTHESIS is that pregnant women in Sweden have mild ID and that children exposed to     mild ID during fetal life have a lower cognitive development, compared to children to mothers     taking 150 ug iodine supplementation during pregnancy.      The MAIN AIM of the SWIDDICH trial is to determine if children exposed to mild iodine     deficiency (ID) during fetal life achieve worse cognitive development compared to children     exposed to normal iodine status reached by maternal iodine supplementation.   "
69335|NCT02378233|"     The aim of the study is to measure urinary milk iodine concentration (MIC), iodine     concentration (UIC), thyroid hormones (TSH, FT4) and thyroperoxidase antibodies (TPOab) in     breast-feeding women, and UIC in their nursing infants to determine if the levels are     adequate, and to see how they can be influenced by 150 ug daily iodine supplementation in     breast-feeding women. The hypothesis is that there is a relative iodine deficiency in this     sub-population - lactating women and nursing children-, and that this can be influenced by     iodine supplementation. Adequate thyroid hormone and iodine levels are very important for     small children, when the plasticity of the brain is greatest.      This is as a prospective, double-blind, placebo-controlled study of 221 mothers and their     infants. In parallel, 90 age-matched healthy non-pregnant women are recruited. Mothers are     randomized to 150 µg/day iodide supplementation or placebo.      Pregnant women are asked for participation on a visit in pregnancy week 37, at the mother     health care (MVC) at Mölnlycke and Skövde. The study will run for approximately 3 months for     each individual and begins by sampling A (UIC, TSH, FT4, TPOab) at week 37 of the pregnancy,     when mothers also get randomized to 150 µg iodine or placebo. New sampling B (UIC, TSH, FT4,     MIC ) is collected when the baby is 3 months old. Thereafter the study is completed. In     parallel, 90 healthy non-pregnant, non-lactating women in the same age range are recruited     and followed with UIC, TSH, FT4, TPOab for 6 months as a control group. In each case a simple     questionnaire is filled and blood is also frozen for future analyses.   "
69336|NCT02378220|"     Patients meeting eligibility criteria will be randomized into two groups, one receiving     pharmacogenetic testing and the other not receiving pharmacogenetic testing. In this     open-label trial, a pharmacist will make medication therapy recommendations using YouScript®     Personalized Prescribing System for patients who receive genetic testing and standard drug     information resources per usual for patients who do not undergo pharmacogenetic testing.   "
70513|NCT02362802|"     This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial     tissue with respect to its potential micro damage measured by several myocardial markers,     especially by high-sensitive TroponinT.   "
69338|NCT02378194|"     Chronic renal failure is a syndrome that renal function is decreased, and the patient number     is increasing. In addition, patients on dialysis have also increased. Depending on the     chronic renal failure aggravated, the deterioration of life caused by the conduct of dialysis     patients is caused. In addition, a problem in dialysis treatment is ongoing economic burden     surface to increase the life of the patient and family. A solution to this problem is, or     stops the progression of chronic renal failure prior to dialysis, it is necessary to delay.     As a treatment for inhibiting the progression of chronic renal failure is present, along with     diet and blood pressure-lowering drugs or a drug therapy used by kremezin. However, the     effect is not enough, new drug development is required.      HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found     during the search active substance that appear when the inflammation in animals. The     investigators confirmed that the substance is present in the urine of a person during the     study, and later established a link between kidney disease hypotheses. When performing the     test in animal model renal failure, chronic renal Through the non-clinical testing of the     HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity test     and antigen tests) showed that a very low toxicity. When going through the review of the     safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory     safety and tolerability. And pharmacokinetic results from the body's absorption in healthy     subjects had been done well, a linear correlation was observed. Finally, it was confirmed     that the most rapidly excreted into the urine.      This study is a Phase 2a clinical trials performed in patients with chronic renal failure in     3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal     failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure     progression and dose setting, and to determine the safety.   "
69339|NCT02378181|"     This study deploys a strategy to develop and evaluate a training-efficient, multimedia     patient-centered Health Education Toolkit to promote shared decision making between     counselors and patients. An existing evidence-based toolkit intervention will be adapted and     redesigned by a patient and provider team into an engaging, narrative graphic novel     curriculum useful in group and individual counseling. The proven behavioral interventions     will be augmented with health education material focused on medication assisted treatment     (MAT). We will assess feasibility and acceptability, and pilot test whether exposure to the     Toolkit (TK) can shared decision making conversations, reduce substance use, and increase     engagement with MAT.   "
69340|NCT02378168|"     Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac     surgery with pharmacological postconditioning (sedation on intensive care unit with     sevoflurane)   "
69341|NCT02378155|"     Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation     in a non-invasive manner. Through the use of near infrared light, the difference between     oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a     numeric result can be calculated.      Since atrial fibrillation (AF) has been linked with an increased risk for the development of     neurocognitive deficits, a longer period of AF might be associated with a higher risk for     neurocognitive deficits.      It is hypothesized that there is an increase in the regional cerebral oxygen saturation     (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.   "
69342|NCT02378142|"     The purpose of this study is to test any good and bad effects of the study drug pazopanib.   "
69344|NCT02378116|"     Because atrial fibrillation occurs frequently in heart surgery patients, our overall     hypothesis is that systematic closing the left atrial appendage during surgery will reduce     cerebral embolism coming from the thrombus formation in the left atrium.      The specific hypothesis which sought tested is that closure of the left atrial appendage in     connection with elective CABG and / or valve surgery will lead to fewer strokes and micro     cerebral infarcts measured by MRI.   "
69345|NCT02378103|"     To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese     XinJiang Province patients.   "
69346|NCT02378090|"     The purpose of this observational study is to characterize individuals in Mexico who seek     medical care for influenza-like illness (ILI) and Severe Acute Respiratory Infection (SARI),     describe seasonal pattern of the pathological agents associated with ILI and SARI and to     identify changes in severity of disease caused by a specific agent.   "
69347|NCT02378077|"     This study is being done to better understand the relationship between inflammation and     insulin resistance in your Adipose (fat) Tissue .   "
69348|NCT02378064|"     The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus     calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT     imaging of carotid artery.   "
69349|NCT02378051|"     The purpose of this study is to examine whether Staying Strong With Schools, a school-based     intervention to support military-connected children, will be helpful for school professionals     and military parents in supporting specific needs of this population of children. As part of     the partnership between three school districts in Massachusetts and the Red Sox Foundation     and Massachusetts General Hospital Home Base Program, the investigators will examine the     efficacy of a training delivered to these schools. The schools will be randomly divided into     two groups (like a toss of a coin). Half of the schools will receive the training in     2014-2015, and the other half will be waitlisted and receive the training the following year     (2015-2016). All participants (school teachers, military-connected children, and their     parents) will be asked to complete questionnaires the first year. The investigators     hypothesize that, compared to the control schools, at the end of the school year, SSWS     schools will be associated with: (1) greater sense of competence and quality of relationships     with military-connected children (MCC) among school professionals; (2) lower parental     distress and increased parental sense of competence and general family functioning; and (3)     increased social support, and fewer academic, emotional, and behavioral problems among MCC.     The investigators hypothesize that an increase in school professionals' sense of competence     in identifying and handling MCC's needs, increased quality of relationships with MCC, lower     parental distress, increased parental sense of competence, and increased general family     functioning will mediate the efficacy of SSWS on MCC's social support and psychosocial     functioning.   "
69350|NCT02378038|"     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a     multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to     characterize anti-tumor activity and collect safety data on patients with Richter's     Transformation.   "
69351|NCT02378025|"     The purpose of this study is to determine whether yoga is effective for the treatment of     chronic pain in Gulf War Illness.   "
69352|NCT02378012|"     This randomized clinical trial studies iPad use in reducing anxiety and depression in     patients undergoing bone marrow transplant. A tablet device like the iPad can provide access     to music, television, movies, books, and the Internet. It also contains a video conferencing     system that can allow patients to communicate with family members and other members of their     social support team. With these capabilities, an iPad distribution program may help lessen     patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may     help doctors better understand how patients use their computers and tablets while in the     hospital so that the software and applications of the iPad can be made more useful.   "
69353|NCT02377999|"     An exploratory open label, single treatment trial of anogenital warts with Picato® repeated     up to 2 times with two weeks intervals.   "
69354|NCT02377986|"     Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve     symptoms of hoarding disorder. To target levels of clutter, the investigators are testing an     intervention to add in-home decluttering practice to the BIT workshop.   "
69355|NCT02377973|"     The overall aim is to provide a detailed description of growth, development and risk factors     for later disease, especially obesity and metabolic disease in infants born by obese mothers     and to compare them with a group of infants born by mothers without any restriction in     prepregnancy BMI (SKOT I).   "
69356|NCT02377960|"     The purpose of this pragmatic multi-centre, cluster randomized controlled trial is to test     the effectiveness of tailored SMS-text message support combined with an     information-motivation-behavioral skills (IMB) model-based initiation of medication in     helping outpatient care patients with hypertension to achieve blood pressure target and to     enhance medication adherence.   "
69357|NCT02377947|"     This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West     Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the     treatment of deep grade HE (West Haven Criteria). The study will be conducted retrospectively     in a single center of a multispecialty tertiary care hospital in India, in which lactulose     retention enema is the mainstay of management of cirrhotic patients with grade 3 or 4 HE     (West Haven criteria). Dosing of lactulose retention enema in this study will be done     according to the dosing described for rectal administration of lactulose (India): 300ml of     lactulose mixed with 700ml of potable water to be used as a retention enema; the enema is to     be retained for 30-60 minutes and repeated every 4-6 hours until the patient is able to take     oral medication. This treatment regime is also the standard protocol of management of deep     grade HE (West Haven criteria) in the study center. The standard treatment protocol of deep     grade HE (West Haven criteria) of the study center will also ensure that all known     contraindications of lactulose will be respected before administration of lactulose retention     enema to the study patients. The retrospective hospital records of the patient population of     interest within the past 6 months will be identified, and these records will be used to     collect data required for analysis.   "
78687|NCT02255903|"     The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and     amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated     postdate pregnancy   "
69358|NCT02377934|"     In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the     tumour is limited by the risk of radiation induced lung damage. This damage is characterized     by parenchymal damage and vascular damage. In rats, we have found that radiation-induced     vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent     loss of pulmonary function could be fully explained by this increase in pulmonary artery     pressure. We hypothesize that also in patients a radiation induced increase in pulmonary     artery pressure can be observed after radiotherapy, which may contribute to the development     of radiation pneumonitis.      The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase     in pulmonary artery pressure.   "
69359|NCT02377921|"     UX001-CL301 is a randomized, double-blind, placebo-controlled study to assess the safety and     efficacy of 6 g/day sialic acid - extended release (SA-ER) treatment as compared with placebo     in subjects with GNE Myopathy.   "
69360|NCT02377908|"     The objective of the study is to give a structured update on geriatric postgraduate education     throughout Europe. The study will be performed as a cross-sectional structured quantitative     online survey with qualitative comments. The survey content covers structural items, content     and educational aspects of geriatric specialty training in European countries.   "
69361|NCT02377895|"     Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and     safety study using the Allergen BioCube (ABC).   "
69362|NCT02377882|"     The investigators tried to explore an alternative non-depolarizing muscle relaxant     (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid     surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection.     Specific time points at which the will be assessed and for EMG signals will be presented.   "
69363|NCT02377869|"     Recently, a novel assay for detecting heavy/light chain (HLC) ratios has been reported which     enables improvement in paraprotein detection and monitoring in multiple myeloma and other     plasma-cell dyscrasias.      The prognostic and biological role of the HLC assay has as yet not been studied in CLL.      Aims of the proposed study:        1. To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL          patients. (In addition to FLC)        2. To study the different patterns of Immunoglobulin's subclass antibodies in the serum of          patients with CLL and compare them to those of to healthy volunteers.        3. To perform a sub-analysis in patients with CLL who have autoimmune phenomenon (AIHA and          ITP)   "
69364|NCT02377856|"     Patients with acute hepatitis C virus (HCV) infection usually become chronicity if viremia     persists after 6 months of infection. The result of using pegylated interferon plus ribavirin     combination therapy upon these patients remains to be explored   "
69373|NCT02377739|"     The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic     obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous     studies. There is only a limited number of therapeutic options for patients with severely     progressed interstitial lung disease (ILD). The question whether chronic hypercapnic     ILD-patients are able to profit from nocturnal NIV and thus increase their performance in     physical training has been left unknown. Therefore, this study aims to evaluate the     feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary     rehabilitation.   "
69374|NCT02377726|"     Internet based self help program with or without support of a counselor is tested among     anonymous Internet help seekers at an open access website.   "
69365|NCT02377843|"     Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A     central reason for low coverage is infrequent and inadequate healthcare provider     recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide     effective recommendations for the vaccine using participatory or efficient communication     strategies.      This study will evaluate the effectiveness of two communication trainings to increase HPV     vaccination coverage among adolescent patients. We will compare HPV vaccination for pediatric     and family medicine clinics receiving a participatory communication training, efficient     communication training, or no training. Ten clinics will be randomly assigned to each study     arm for a total of 30 clinics. The primary outcome of this study is to compare the change in     clinics' levels of HPV vaccination initiation coverage among 11-12 year old adolescent     patients from baseline to 6 month follow-up. Secondarily, we will compare the change in HPV     vaccination initiation coverage in 13-17 year old adolescents.   "
69366|NCT02377830|"     Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need     advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4     have severe leg weakness impairing their quality of life for as long as 5 years after ICU     discharge. In-bed cycling involves use of special equipment that attaches to a patient's     hospital bed, allowing them gentle exercise while in the ICU.      Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to     survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed     cycling each day they are in the ICU or routine physiotherapy, both delivered by specially     trained physiotherapists.      Outcomes: Feasibility: The investigators will study whether patients can cycle on most days     of their ICU stay, whether patients and their families agree to be a part of the study, and     whether investigators can systematically assess patients' strength.      Relevance: Effective methods of physiotherapy are needed for critically ill patients to     minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized     study is the second of several future larger studies about in-bed cycling in the ICU.   "
69393|NCT02377479|"     The goal of the study is to measure serial hormonal levels in patients undergoing clomiphene,     letrozole, and a combination clomiphene and letrozole cycle. This information may help us to     optimize less expensive medications for ovulation induction, reduce the number of treatment     cycles to achieve a successful pregnancy, and use a medication regimen that may result in     fewer multiple gestation pregnancies.   "
69403|NCT02377349|"     The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when     compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45     years. Infants born to mothers enrolled in this study will be followed-up in two separate     clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST: 048].   "
69367|NCT02377817|"     Back and right-sided sleeping position in pregnant women has recently emerged as a potential     risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature. Assuming     that sleep position in pregnant women is modifiable, the same literature has indicated that     this risk factor is modifiable; however, there is no evidence that this risk factor is truly     modifiable.      The proposed link between back and right-sided sleeping position in a pregnant woman and LBW     and SB of her baby is multifactorial; however, it ultimately implicates the woman's body     position in causing compression of one of the large veins that brings blood back to her     heart. This compression, along with other factors relating to the woman, her placenta, and     her developing fetus, may result in decreased blood flow (nutrition and oxygen) to her     developing baby, which, depending on the extent and duration, could result in LBW or SB of     her baby. If the back sleeping position during pregnancy has a causative role in LBW and     subsequently SB, the literature indicates that up to 17% of LBW and consequently 26% of SB     could potentially be prevented by changing position to avoid back sleep. Note that 20 million     LBW and 2.6 million SB occur each year worldwide.      Positional therapy (PT) is a safe and effective intervention for preventing people who snore     or people who's breathing pauses during sleep from sleeping on their back - a position that     makes their condition worse. The most basic form of PT modifies a person's sleeping position     by either:        -  Preventing them from sleeping on their back through restricting their movement, or        -  Rather than restricting movement, significantly reducing the amount of time they spend          sleeping on their back by applying pressure points to their body while they are on their          back, which eventually causes them to shift into a different position and avoid lying on          their back.      The purpose of this study is to evaluate the ability of a PT intervention to modify the     position of pregnant women from their back and right side to their left side while they sleep     in late pregnancy.      This study will help determine whether this potential risk factor is modifiable by way of a     PT intervention, and whether it is feasible to intervene to reduce or prevent back and     right-sided position sleep in late pregnancy. Demonstrating that the sleeping position of     pregnant women can be modified through use of a simple, inexpensive PT intervention may be     one of the keys to achieving significant reductions in LBW and late SB rates in Canada and     worldwide.   "
69368|NCT02377804|"     Stroke is the leading cause of physical disability due to the presence of spasticity.     Different needling techniques, including Botulinum Toxin A are proposed for management of     spasticity; however results are conflicting. The presence of spasticity in the upper     extremity implies several impairments for daily life activities. No study has investigated     the effects of deep dry needling inserted into the targeted spastic musculature of the     shoulder region in patients who had suffered a stroke. The investigators will conduct a     randomized controlled trial investigating the effects of the inclusion of deep dry needling     into a rehabilitation program over the musculature of the shoulder region, pressure pain     hyperalgesia and range of motion in individuals with chronic stroke. The investigators     hypothesize that patients receiving dry needling into the spastic shoulder musculature would     exhibit greater improvements in spasticity, pressure sensitivity and range of motion than     those who will not receive the intervention.   "
69369|NCT02377791|"     Tacrolimus is a drug used commonly in kidney transplant patients to prevent graft rejection.     Tacrolimus acts in a very narrow range in the blood for its optimum activity. If the levels     are too high, there is a risk of kidney injury, whereas, if the levels are too low there is a     higher risk of rejection and graft loss. Genetic differences in the gene coding for the     enzyme cytochrome P450 (CYP3A5), which is responsible for breaking down active tacrolimus can     contribute to variations in blood levels of tacrolimus among different individuals taking the     same dose of the drug. Certain genetic types lead to low concentrations, whereas certain     genetic types can lead to high levels. The proportion of individuals with different types of     genetic variations differ among different ethnic populations. Limited data are available in     Thai subjects or on the risk have having certain types of genetic variations on the risk of     rejection.      This study aims to compare the effects of different types of CYP3A5 gene variations on     Tacrolimus drug levels and risk of acute rejection in Thais.   "
69370|NCT02377778|"     In this study the aim is to compare the effect of the type of anaesthetic drug used during     oocyte retrieval on fertilization rates of oocytes retrieved after ovarian stimulation for     in-vitro fertilization.   "
69371|NCT02377765|"     This study will help to determine the effectiveness of a self-supervised, home-based     Transcutaneous Posterior Tibial Nerve Stimulation treatment protocol in maintaining     Overactive Bladder (OAB) symptoms improvement in women responders to Posterior Tibial Nerve     Stimulation (PTNS)   "
69372|NCT02377752|"     This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate     safety and side effects of olaratumab in combination with doxorubicin in Japanese     participants with a group of rare cancers (advanced solid tumors, especially advanced soft     tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets     into the blood stream of Japanese participants with advanced solid tumors and how long it     takes the body to get rid of it.   "
69375|NCT02377713|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's     Disease.   "
69376|NCT02377700|"     Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be     used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The     prosthesis is immediately mechanically functional, while its physiochemical characteristics     should enable cell infiltration and tissue formation.      The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical     outcomes by reducing synthetic material related complications and improving hemodynamic     characteristics.   "
69377|NCT02377687|"     To study the impact of emergency high risk GI surgery on HRQOL in elderly patients,     seventy-five years or above and to explore the patients' experience with the informed consent     process and the status 6 months after surgery.   "
69378|NCT02377674|"     The extracardiac Fontan surgery/procedure involves diverting the venous blood from the     inferior vena cava to the pulmonary arteries without passing through the morphologic right     ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is     connected to the inferior vena cava and the other end to the pulmonary artery confluence.      Xeltis developed a biodegradable prosthesis, the Xeltis Vascular Graft Model COR-VG-001, to     be used as an extracardiac conduit between right atrium and the pulmonary arteries. The     prosthesis is immediately mechanically functional, while its physiochemical characteristics     should enable cell infiltration and tissue formation.      The Xeltis Vascular Graft Model COR-VG-OO is specifically designed to enhance the Fontan     surgery outcome by reducing synthetic material related complications and improving     hemodynamic characteristics.   "
69379|NCT02377661|"     The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance     blood pressure control in primary care by introducing a standardised and simplified titration     regime with single pill combinations (SPC), comprising an angiotensin receptor blocker,     calcium channel blocker and hydrochlorothiazide.   "
69402|NCT02377362|"     This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese     healthy participants after single doses (in Part A), and in participants with type 2 diabetes     mellitus after multiple doses during a 28-day period (Parts B and C).   "
69380|NCT02377648|"     The CART Pilot study was designed to provide preliminary observations (about performance and     safety) and generate hypotheses for future studies . The primary goal of the study is to     evaluate the performance at one year of second-generation ABSORB Bioresorbable Vascular     Scaffold (BVS)(Abbott Vascular, Santa Clara, CA , USA), the Everolimus Eluting Bioresorbable     Vascular Scaffold, in heart transplant recipients affected by cardiac allograft vasculopathy     (CAV) and significative coronary stenosis.      The secondary objectives are:        -  to collect data about the procedural and clinical outcomes post-procedure , 30 days, 180          days and at 1,2 and 3-year follow-up, of patients who underwent ABSORB BVS implantation          in order to investigate the safety of the device in CAV population;        -  to evaluate the progression of the disease and the its interactions with the study          device by using data derived from multi-imaging invasive techniques.      The vascular reparative therapy and in particular the BVS technology showing important     advantages in terms of endothelial preservation, adequate vasomotion, and restoration of the     media and adventitia of the vessel wall, could represent a new and more effective therapeutic     option, compared to bare-metal and drug-eluting stent technologies, for transplanted     patients, since all these mechanisms may, at least in part, counteract the detrimental     changes leading to CAV, namely constrictive remodeling and rapid atherosclerosis progression.      Subjects enrolled into the clinical study will be male or female derived from the heart     transplant recipients population of every participating center. The clinical study will     enroll 30 subjects. Subjects, who underwent the yearly expected coronary angiography     follow-up after heart transplant surgery, meeting the general and angiographic inclusion and     exclusion criteria (eligibility will be assessed by Heart Team consensus) will be asked to     sign an informed consent form. Subjects who do not meet inclusion and exclusion criteria are     subject to the standard follow-up of heart transplant (HTx) recipients and will undergo to an     invasive evaluation after 365 ± 28 days.      The study comprises two distinct phases:        -  the enrollment phase which starts with the recruitment of the first subject and it is          planned to last one year;        -  the follow-up phase which is planned to last three years from the enrollment of the last          patient.      The total duration of the study will be of four years, including both the enrollment and the     follow-up phases   "
69381|NCT02377635|"     This clinical trial should prove that selenium can treat arsenic exposure in humans by     promoting excretion. The new trial differs from previous trials in that participants will be     maintained in a local clinic and provided with food and water from their home villages. The     purpose of this study to determine the fate of selenium supplements in feces, urine and blood     of volunteers living in conditions of high arsenic load in drinking water. The use of a     clinic will enable monitoring of all intake and excretion of both arsenic and selenium, and     will ensure that participants take their selenium doses or placebo as appropriate. This proof     of concept is absolutely essential groundwork for any remediation strategy involving selenium     supplements.   "
69382|NCT02377622|"     The study investigates the performance of a new dialyzer (Theranova 400) containing a     membrane with increased pore sizes. The performance will be determined by the removal of     middle molecules (with different molecular size) from the blood compartment. Two different     Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a     Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated in     high volume hemodiafiltration mode. Safety events and albumin loss into the dialysate will be     monitored   "
69383|NCT02377609|"     The principal aim of this study is to define the relationship between tacrolimus     concentrations determined from the finger prick DBS (Dry Blood Spot) method and those     determined from blood samples collected by venepuncture in transplant recipients.   "
69384|NCT02377596|"     Our long term objective is to enhance the pediatrician's management of children with feeding     difficulties in a primary care office-based pediatric practice setting. A prerequisite is to     rapidly reach an accurate diagnosis so that appropriate therapy can be applied. To improve     the efficiency and accuracy of the diagnostic interview the investigators have designed a     Feeding Difficulty Diagnostic Tool (FDDT) consisting of a set of questions that fit beneath a     'diagnostic cover' and prompts for basic information. Depending on the answers rendered on     the questionnaire particular diagnoses noted on the cover are flagged for consideration.      In this study our specific objectives are 1) to assess the feasibility and acceptability of     using the FDDT in the pediatrician's office and 2) to obtain preliminary data on the     reliability of using the instrument in the diagnosis and management of children with feeding     difficulties.        -  Feasibility and acceptability are often interrelated and will be assessed in a broad          sense by questionnaires that ascertain, for example, the amount of time needed by          parents and staff to fill in and use the FDDT questionnaire, the ease and difficulties          encountered in filling out the FDDT questionnaire and the understanding of the          questionnaire by the parents.        -  Reliability relates to the usefulness of the FDDT questionnaire for the pediatrician in          obtaining and organizing the information obtained from the history and physical          including anthropometric data to reach a correct diagnosis, the latter being judged in          this study against the diagnosis reached independently by trained experts in pediatric          feeding difficulties using a modification of their standard diagnostic interview. The          frequency of presentation of the various diagnostic sub-categories and the extent of the          discrepancy between the conclusions suggested by the FDDT, the pediatrician, and the          feeding disorder experts is unknown. Therefore' this pilot study is needed to help          determine the sample size necessary to power a more definitive study of the diagnostic          tool's accuracy, if necessary. The investigators anticipate that at least three of the          categories (children with excessive selectivity, children with demonstrably poor          appetite who are vigorous and free of organic disease, and those misperceived to have          feeding limitations) will be well represented in this preliminary study.   "
69385|NCT02377583|"     The general objective is to precise the role of HPA axis activity in neuropsychological     consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA axis     is associated with higher scores of depression and changes in hippocampal volume and mean     diffusion.   "
70595|NCT02361723|"     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment     effect of a new drug known as BGB-290 in patients with solid tumors.   "
69386|NCT02377570|"     The study investigates the performance of a new dialyzer (Theranova 400) containing a     membrane with increased pore sizes. The performance will be determined by the removal of     middle molecules (with different molecular size) from the blood compartment. Three different     Theranova 400 prototypes (AA, BB and CC) operated in hemodialysis mode will be compared with     a Cordiax FX-80 dialyzer, operated in hemodialysis mode. Safety events and albumin loss into     the dialysate will be monitored   "
69387|NCT02377557|"     To assess incidence of adverse drug reactions and use pattern of topical steroids among     patients who are prescribed or purchase over the counter (OTC) topical steroids for skin     conditions in Korea   "
69388|NCT02377544|"     Hopefully this research can help to provide the optimal nutrition management from pregnancy     so that the babies wiil born with better quality of health and reduce the morbidity and     mortality.      Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of     probiotics supplementation on pregnant women to the baby especially from inflammation     pathways. The investigators hope the result of this research can help reducing infant     morbidity and mortality rate in Indonesia, also has a benefit for future research.   "
69389|NCT02377531|"     In the current study we aim to determine if early glucose screening and treatment among women     at high risk for GDM improves perinatal outcome and decreases gestational weight gain. Half     of the participant will be assigned to an early glucose screen group (12-18 weeks) and     treatment if necessary and the other half to a standard 24-28 weeks glucose screen.   "
69390|NCT02377518|"     Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous     contrast media in order to study the in vivo ventilation.      Two different clinical situations will be tested :        -  Prediction of postoperative pulmonary function for oncologic patients        -  Detection of Bronchiolitis Obliterans in lung transplant recipients.   "
69394|NCT02377466|"     The study's primary objective is to demonstrate the superiority of retosiban to prolong     pregnancy and improve neonatal outcomes compared with placebo. It is a Phase III, randomized,     double-blind, parallel-group, multicenter study and will be conducted in approximately 900     females, aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes     in preterm labor between 24^0/7 and 33^6/7 weeks of gestation. Eligible maternal subjects     will be randomly assigned in a 1:1 ratio to receive either retosiban IV infusion or placebo     IV infusion over 48 hours. If not previously administered, antenatal corticosteroid treatment     should be administered as either (1) two 12-mg doses of betamethasone given intramuscularly     24 hours apart or (2) four 6-mg doses of betamethasone administered intramuscularly every 12     hours. A single rescue course of antenatal corticosteroids is permitted if the antecedent     treatment was at least 7 days prior to study enrolment. Investigators have discretion to use     a standardized regimen of magnesium sulphate, as well as intrapartum antibiotic prophylaxis     for perinatal group B streptococcal infection. Prior to randomization, each subject will be     stratified by progesterone treatment and gestational age. The progesterone strata will     consist of subjects on established progesterone therapy or subjects not on established     progesterone therapy at Screening. The study will comprise 6 phases: Screening, Inpatient     Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post-Delivery Assessment,     and Neonatal Medical Review. The duration of any subject's (maternal or neonatal)     participation in the study will be variable and dependent on gestational ages (GA) at study     entry and the date of delivery.   "
69395|NCT02377453|"     A longitudinal study of function and participation in patients with stroke: An integrated     brain imaging and biomechanical analysis   "
69396|NCT02377440|"     The investigators hypothesize that older persons (≥45 years) treated with ACEI for HTN     control will have: i) improved status of bone turnover (decreased P1NP and CTX), and ii)     decreased levels of RANKL and RANKL/OPG, compared to those not treated with ACEI and not     using RAS-related medications   "
69397|NCT02377427|"     Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits     dose proportional and time-independent pharmacokinetics. The study will be conducted in 2     parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to     support the use of mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma     and characterize the PK/PD of mepolizumab 40 milligrams (mg) or 100 mg administered     subcutaneously depending on participant body weight. Part B: It is a long-term safety /     pharmacodynamic phase in which extended treatment for a further 52 weeks will be offered on     an optional basis to those subjects eligible for continued treatment. Participants with     bodyweight <40 kilogram (kg) will be dosed with mepolizumab 40 mg and participants with body     weight >=40 kg will be dosed with mepolizumab 100 mg subcutaneously in upper arm or thigh at     Visit 2 (Week 0). Approximately 40 male or female participants aged 6 to 11 years will be     screened to achieve approximately 28 eligible participants entering the treatment phase to     allow availability of 20 evaluable participants, with a minimum of six participants enrolled     in the <40 kg bodyweight group. The total duration of the study will be 22 weeks and will     include a run-in period of 1-2 weeks, a treatment period of 12 weeks and a follow-up phase of     8 weeks. A participant will be considered having completed the study if the participant     completes all phases of the study including the follow-up phase (Week 20 [visit 8]).   "
70114|NCT02368067|"     The purpose of this study is to compare the Instillation Technique Using The Modified Intra-     Uterine Manipulator Catheter With Methylene Blue, Isosulfan Blue or Indocyanine Green Dyes,     Compared to Cervical Injection, For Sentinel Lymph Node Detection in Endometrial Carcinoma.   "
69398|NCT02377414|"     This study in healthy, adult Japanese women will characterize the PK, safety and tolerability     of retosiban at the therapeutic doses planned to be evaluated in Phase 3. The PK data will be     compared to a sub-set of Caucasian women given the same dose of retosiban. This study has two     cohorts, cohort 1 will be a double-blind sponsor-open (subjects and investigator blinded and     sponsor unblinded), randomized, continuous 48 hours (h) infusion study in healthy, adult     Japanese women of child-bearing potential. Cohort 2 is an open label and continuous retosiban     48 h infusion study in Caucasian, adult, healthy women of child bearing potential. So, the PK     can be compared with those of Japanese women. Approximately 32 subjects will be enrolled. In     cohort 1, approximately 24 subjects will be enrolled and randomized to retosiban and placebo     (2:1 ratio) to have 18 women with 12 active, 6 placebo completed subjects. In Cohort 2, 8     subjects will be enrolled to have 6 competed subjects. The total duration of a subject's     involvement in this part is anticipated to be up to 6 weeks (including the 28 day screening     period).   "
69399|NCT02377401|"     Zanamivir is a potent and highly selective inhibitor of the influenza virus neuraminidase.     Intravenous (IV) zanamivir is being developed for treatment of hospitalized patients with     influenza, especially for those patients who may be in greatest need of parenteral influenza     antiviral agents. This study is a pharmacokinetic (PK) study to evaluate the     safety/tolerability and pharmacokinetic profiles of IV zanamivir 300 milligrams (mg) and 600     mg in Chinese healthy subjects. Subjects will be randomized to receive either 300 mg or 600     mg IV zanamivir as a single dose followed by repeated dose every 12 hours (h) for 5 days.     Subjects will be contacted or will return to study center for a follow-up visit, 7 days after     the last dose or withdrawal from the study. Total number of subjects planned for enrollment     will be 24 such that approximately 10 subjects complete dosing and critical assessments in     each dose cohort. The total duration of the study will be approximately 6 weeks from     screening to follow-up.   "
69400|NCT02377388|"     Cardiovascular events are the main cause of mortality in diabetic patients ,on the other     hand,during an acute myocardial infarction(AMI),hyperglycemia increases mortality and is     related to different pathophysiologic processes.      More important evidence regarding the effect of glycemic control on AMI patients prognosis is     contradictory,and the potential benefits of dipeptidyl peptidase-4 inhibitors(DPP4i) in this     setting is unknown.      The aim of this study is to assess the presence of pleiotropic effects of saxagliptin(DPP4i)     and their relationship with glycemic control during the in-hospital phase of AMI.   "
69401|NCT02377375|"     When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an     unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al.,     2013). The objective of this trial is to investigate whether the use of a micro-electrode     assisted technique improves targeting precision in DBS at the BNST.   "
69404|NCT02377336|"     This study will evaluate the effect of GS-6615 in adults with chronic stable angina and     coronary artery disease (CAD) receiving a stable daily dose of up to 2 antianginal     medications. The study will consist of two periods: a 1 to 3 week Qualifying Period and a     Treatment Period lasting 13 days (± 3 days). During the Qualifying Period and at the end of     the Treatment Period, participants will undergo exercise tolerance testing.   "
69405|NCT02377323|"     The purpose of this study is to determine whether Rebif has an impact on employment status,     quality of life and cognition.   "
69406|NCT02377310|"     Instantaneous wave-free ratio (iFR™) is a novel non-hyperaemic index of the functional     significance of a coronary stenosis. Previous studies have shown variable levels of     correlation with the established hyperaemic index FFR. In addition it has been proposed that     iFR™ has superior diagnostic accuracy when compared to mean whole cardiac cycle Pd/Pa which     can also be used to predict FFR.      We plan to undertake a prospective clinical study in consecutive patients already undergoing     FFR assessment in the cardiac catheterisation laboratory to compare the ability of iFR™ and     Pd/Pa (both measured using the proprietary Volcano system) to predict FFR. We will explore     the level of misclassification of flow limiting disease that results from use of iFR™ and     resting Pd/Pa employed using either binary cut-off algorithms or in a hybrid decision making     protocol. We plan to analyse 260 vessels over a 18 month period. Hyperaemia will be induced     by intravenous adenosine (140 ug/kg/min) administered wherever possible via an antecubital     vein. Intra-coronary nitrates will also be given in line with the standard care procedure for     FFR measurement. Final clinical decisions following coronary physiology will be based on     steady state FFR.   "
69407|NCT02377297|"     The aim of this study is to evaluate the survival rate and the cost-effectiveness of     occlusal-ART restorations using three GIC brands (Fuji IX, GC Europe; Maxxion R, FGM; Vitro     Molar, DFL) in primary molars.   "
69408|NCT02377284|"     This pilot study will test the use of visual cues to engage food service workers in     protecting patrons with food allergies. Food service workers from Philadelphia quick-service     restaurants were recruited to participate in a survey of attitudes that includes an embedded     randomized experiment testing an experimental cue (photograph of an allergic child) to     increase workers' engagement and empathy.   "
69409|NCT02377271|"     Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after     glaucoma in the population aged over 50 years. The visual prognosis of the condition is     unfavorable in the great majority of cases, with significant effects on the visual field and     vision. The severity of the unilateral condition is also associated with bilateralization in     15% at 5 years. There is no effective treatment for the acute phase of the disease or to     reduce the rate of bilateralization. In this context, it is essential to develop new     therapeutic strategies in the acute phase of the disease to reduce the anatomical optic nerve     damage.   "
69412|NCT02377232|"     Several screening methods exist to screen patients for CRC ranging from invasive (i.e.,     colonoscopy) to less invasive (i.e., testing the stool for blood). Although choice between     screening methods is recommended, patients are not currently offered an unbiased choice and     physicians generally recommend only colonoscopy. In this project, the investigators will     answer the following questions: 1) Is it feasible to incorporate a DA in the AHP protocol?;     2) Is it feasible to incorporate mailing patients a stool blood test?; 3) Does the DA change     CRC screening decision quality, using proxy measures such as knowledge and intent; and 4)     Does the DA change the proportion of participants that complete a CRC screening test? To     answer these questions the investigators will compare survey responses and CRC test type     completed between two AHP CRC surveillance patients groups - those that received usual care     versus those that received the DA.   "
69413|NCT02377219|"     Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its     free and conjugated forms in blood and urine) and embryo implantation rate (measured as the     ratio between the number of gestational sacs and the number of transferred embryos) after     assisted reproductive technology. In order to reduce the confusion factors, the population     study is limited to young women (aged 28 to 34), with regular menstrual cycles and without     any medical event that could affect the implantation process   "
69414|NCT02377206|"     The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease     subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its     relationship with the kinetics of cognitive decline over a 24-month follow-up period (as     assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and     Mini-Mental State Examination (MMSE) scores).   "
69415|NCT02377193|"     Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte     globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies     (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially     in highly sensitized patients. Both induction therapy regimens have a different tolerance     profile. Infections and haematological side-effects are more frequently reported in patients     receiving ATG.      The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo     sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor specific     antibodies (DSAs) detected by Luminex.   "
69416|NCT02377180|"     There is currently no specific diagnostic test for primary muscular pain. The present study     investigates whether selective blockade of the suprascapular nerve can effectively abolish     experimental pain arising from the supraspinatus muscle. Experimental muscle pain is induced     by intramuscular injection of capsaicin, an alkaloid from red chili peppers. The study     consists of three parts:        1. to describe the development, time course and intensity of capsaicin-induced muscle pain        2. to evaluate the effectiveness of suprascapular nerve block against capsaicin-induced          muscle pain        3. to compare suprascapular nerve block and direct intramuscular local anesthetic          infiltration for their effectiveness in capsaicin-induced muscle pain   "
69519|NCT02375841|"     The purpose of this study is to learn more about the way physicians communicate with brain     tumor patients. This study will look at how oncologists provide information about brain     tumors, brain scan results, and treatment options. This study will look at how oncologists     provide information about brain tumors, brain scan results, and treatment options.     Ultimately, the investigators hope to use these findings to improve communication between     patients, caregivers and their doctors.   "
69417|NCT02377167|"     Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation,     have a particularly bad prognosis. If they require long-term ventilation, their orotracheal     tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal     tube below the larynx. This so called tracheostomy might be associated with advantages such     as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth     hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for     tracheostomy in stroke, however, is not known. Preliminary data from a pilot study of early     tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may     also have improved survival and long-term functional outcomes, but a large, multicenter     clinical trial is needed to confirm these findings.   "
69418|NCT02377154|"     The purpose of this study is to determine if the keratometric functions of the VERION Image     Guided System are comparable to those of established keratometric devices (IOLMaster 500,     Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical     consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image     Guided System.      In addition the comfort and duration of examination in the different devices is evaluated.   "
69419|NCT02377141|"     Gastro-oesophageal varices (swollen veins in the gullet and stomach) are present in 50% of     patients with liver cirrhosis and are its most serious complication as their rupture results     in potentially life threatening bleeding. Bleeding from these veins occurs in up to one third     of patients with varices. This is associated with 20% mortality at 6 weeks.      In the event of bleeding from these veins the current UK guidelines recommend certain drugs     followed by early endoscopic treatment with variceal band ligation (rubber bands placed over     the veins to stop them bleeding). The use of a shunt inside the liver (TIPSS transjugular     intrahepatic portosystemic shunt) is largely reserved for cases of uncontrolled bleeding from     these swollen veins. A recent randomised multicenter study carried out by Garcia Pagan and     colleagues reported improved survival with early TIPSS in patients with bleeding from these     swollen veins in advanced liver disease. From these guideline international guidelines now     recommend consideration of early TIPSS for all high-risk patients presenting with variceal     bleeding. This practice clearly has significant cost implications. To validate the findings a     further randomised control trial is needed.      This is a multi-center parallel-group randomized controlled trial. Both hospitals taking part     in the trial will have a TIPSS service. Patients who consent to enter the trial will be     randomized to either: (1) Endoscopic treatment (standard care) or (2) early TIPSS.      Potential participants will be all patients with a diagnosis of liver cirrhosis presenting     with an acute variceal bleed to a participating hospital who do not fulfill an exclusion     criteria. All causes of cirrhosis will be included.      Participants will be reviewed during their regular hepatology clinic appointments at their     respective hospitals on 3 occasions over a one-year period.   "
69420|NCT02377128|"     The aforementioned study was designed to evaluate short term ovarian reserve as assessed by     anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation,     as part of cesarean sections performed in women requesting future sterilization. The     investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the     investigators' institution, 2 of which request sterilization (allocated to tubal ligation or     bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have     blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following.     This is preformed in light of validated data offering better sterilization and possible     diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be     just as safe as tubal ligation. This will be performed as a randomized controlled trial.   "
70636|NCT02361190|"     The proposed study will test the effects of a fast-acting testosterone nasal spray on the     fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a     double-blind randomized experimental design.   "
69421|NCT02377115|"     Postoperative delirium (PD) - a temporary state of confusion - is a frequent complication of     surgery, which most commonly occurs in elderly patients. A computer program that may assist     in preoperative screening for postoperative delirium was developed at the University Hospital     Basel in 2014. This study will be conducted with the aim to investigate if the computer     program may assess the risk of a patient to develop PD.   "
69422|NCT02377102|"     Purpose: For the target population of adult patients with end stage osteoarthritis, this     randomized clinical trial will be used to evaluate the benefit of three months of physical     therapy compared to no treatment in patients indicated for total knee arthroplasty.      Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for     total knee arthroplasty.      Procedures: Patients will be randomized to either receive physical therapy or no treatment.     They will be scheduled to return in 3 months for discussion of operative versus continued     nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS     (Patient Reported Outcome Measurement Information System) score and prevention of surgery.   "
69423|NCT02377089|"     The investigators propose to use a clinical trial to test Trigeminal Nerve Stimulation (TNS)     to examine the efficacy of TNS as a new treatment for PTSD in veterans. Recruitment will take     place at the PTSD Outpatient Clinic at the VA GLA. Study participants will be asked to     complete, at most, 9 assessments/questionnaires regarding their PTSD symptoms and quality of     life, use the TNS device every night for 8 hours, log their use of the device, and attend     weekly visits to monitor safety and complete assessments. Each subject will be asked to     attend 8 visits over the course of 8 weeks. Subjects who receives the sham-controlled     treatment will have an additional follow-up phone visit 4 weeks after the week 8 endpoint to     examine symptom improvements.      Enrollment and subject-related procedures are projected to take approximately 36 months.     Preparations for clinical trial, clinical trial/study procedures and data analysis will     occupy a 6 month period, a 36 month period, and a 6 month period, respectively. The duration     of this project is approximately 4 years.   "
69445|NCT02376803|"     Warfarin is an anticoagulant medication that is highly effective at preventing clotting     disorders but which has a narrow therapeutic window. If warfarin is under effective patients     are at risk of stroke, if it is over effective patients are at risk of bleeding     complications. Physicians routinely and regularly measure a blood test (called the INR)     that determines the effectiveness of warfarin and have a range of test values (the     therapeutic range) in which they try to keep the patient. By convention warfarin is taken     at dinnertime, however this is the same time of day that highly variable consumption of     dietary vitamin K occurs (found largely in green leafy vegetables) and vitamin K alters the     effectiveness of warfarin. Given vitamin K has a very short half-life (i.e. it is only active     for a short period of time after it is ingested) it may make more sense to take warfarin in     the morning (when very little vitamin K is ingested) to produce a more consistent drug     effect. The purpose of this study is to determine whether switching current warfarin users     from evening to morning dosing decreases time spent outside the therapeutic INR range.   "
69424|NCT02377076|"     Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of     type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and     increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of     dietary calcium supplementation in permeability and intestinal microbiota in overweight type     2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study.     Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL)     or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed     containing 800 mg of calcium from dietary sources / day. During intervention period, a     beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of     calcium as milk powder) will be ingested in the laboratory. Food intake, body composition     (total body fat and fat free mass) and anthropometric measures (waist circumference,     waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be     evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut     permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy     vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric     acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers)     will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed     with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or     non-parametric tests will be applied, according to the distribution of variables (level of     statistical significance of 5%).   "
69425|NCT02377063|"     This is a 4 ½ week study with 20 healthy subjects (including a 2 week run-in ) . Subjects     will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool     samples will be collected at baseline, day 4 and day 17. The purpose of the study is to     determine the effects of fruit/vegetable supplementation on colonic flora.   "
69426|NCT02377050|"     The primary hypothesis is that preterm infants who are less than or equal to 32 weeks     gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a     feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160     ml/kg/day   "
69427|NCT02377037|"     There is already a lot of scientific evidence supporting the benefits of public health     recommendations regarding physical activity (the accumulation of at least 150 minutes of at     least moderate intensity physical activity per week). However, these 30 daily minutes     represent only about 3% of the waking period. Recent data suggest that most of the population     spends on average 8-9 hours / day of sedentary behavior (SB). SB is characterized by any     activity with a metabolic cost (MC) below 1.5 METs, mainly actions in the sitting position.     In fact, there is evidence that the more time spent sitting higher the risk of disease and     mortality, with sitting directly associated with diseases such as type II diabetes,     cardiovascular diseases and even cancer. The average life expectancy may increase by ~ 2     years if the investigators reduce sitting about 3h/ day. Additionally, how people accumulate     sitting time seems to be a major factor, with prolonged sitting associated with a higher risk     of disease. Short-term experimental studies indicate that sedentary lifestyles affect energy     balance enhancing weight gain. While there is some research regarding the MC associated with     sitting and standing behaviors, the results are contradictory. Besides these conflicting     results, the impact of transitions between these two types of behavior and how these     transitions can contribute to MC increase have never been investigated.      Our hypothesis is that, in both men and women, the simple replacement of sitting for     standing may not substantially increase MC, but instead, the largest contribution may     reside on the transitions between these two states of behavior. Therefore, the investigators     will perform a study with the following purposes:      Examine MC and HR associated with sitting, standing, and transitions between these two     types of behavior in adults of both gender, apparently healthy with variable body composition     profiles.   "
69428|NCT02377024|"     The objective of this study is to demonstrate the cognitive enhancement effect and safety of     Tremella Fuciformis, using the cognitive and clinical indicators (e.g. memory, attention, and     psychomotor speed) and the latest brain imaging methods for healthy adults suffering     subjective cognitive impairment.   "
69429|NCT02377011|"     A randomized controlled trial to test the whether remote delivery of cognitive based therapy     (CBT) is clinically and cost effective when compared to treatment as usual in adolescents and     young adults with depression who self-harm.   "
69430|NCT02376998|"     Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute     transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is     associated with high rates of morbidity and mortality and in this view endovascular treatment     seems to be a valid and safer alternative. Aim of this study is to review the experience of a     single center with endovascular approach for the treatment of acute traumatic rupture of     descending thoracic aorta   "
70637|NCT02361177|"     The investigators are interested in the impact of intranasal oxytocin in unethical behavior.   "
69431|NCT02376985|"     To examine whether the occurrence of oral mucositis can be reduced by dental oral management     in patients by comparing the use of dental oral management through instruction by dental and     oral surgeons (dental oral management group) and an observation group (brushing instruction     only group) in a randomized, controlled study in females that are using everolimus for     estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.   "
69432|NCT02376972|"     THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF     RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS   "
69433|NCT02376959|"     Background: The use of alternative therapies in medicine has been increasing worldwide. Among     these therapies are energy therapies such as Reiki , Johrei, and Spiritist passe.     Experimental studies have confirmed the action of the energy therapies in animal models or in     cell cultures. These therapies appear to have positive effects, particularly in the reduction     of anxiety and pain. Objective: To evaluate the effectiveness of the passe energy therapy     in reducing anxiety in subjects presenting anxiety symptoms after 8 weeks of study. Methods:     The recruited volunteers will be randomized into two groups: the Control Group (application     of 8 passe simulation sessions by people without spiritualist training at the same time and     in the same environment as the treatment group) and the Treatment Group (application of 8     sessions of passe by spiritists with over 2 years of experience in controlled environments     for the same period as the control group). The sample will consist of 60 patients selected by     interviews with the expectation of a 20% reduction of anxiety in the control group and 60% in     the treatment group with alpha of 0.05 and beta of 0.8. Results: Using the STAI scale for     evaluation, the reduction in anxiety is expected to be significantly higher in the treatment     group than in the control group. The investigators expect approximately 20-30% reduction of     the anxiety in the control group by the placebo effect. Other objectives to be assessed are     quality of life, spirituality, and depression by specific standardized scales (WHOQOL-BREF,     DUREL, and BECK).   "
69434|NCT02376946|"     This study is a prospective, randomized, double-blinded, controlled, clinical trial that     evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and     pain after extraction of impacted third molars. The study group will be comprised of subjects     that will receive PEMF Actiband treatment for postoperative management of pain and edema. The     control group will be comprised of the subjects that will receive a placebo patch as     treatment for postoperative management of pain and edema.      Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until     60 qualified subjects have been recruited. Eligibility criteria will be based on the     standards for conducting oral surgery procedures on third molar extractions, in addition to     safety considerations and contraindications for the Actiband and other agents to be used.     Moreover, the selected subjects will have the same surgical difficulty and surgical trauma     anticipated standardized by classification system of impacted third molars. All inclusion and     exclusion criteria will be thoroughly explained in the relevant section of this proposal.     Postoperative edema and pain will be evaluated using 3dMD and Visual Analog Scale,     respectively. Different measurements will be obtained immediately before the surgery and in     standard periodic intervals as described in the Materials and Methods section of the     proposal. Any difference in postoperative edema, pain, and site responsible for request of     rescue pain medication will be compared and analyzed between the two groups.   "
69435|NCT02376933|"     Vertebral augmentation with radiotherapy to increase the functional status and quality of     life for patients with vertebral body metastatic cancers.   "
69436|NCT02376920|"     Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every     year. Nearly half of these experience spread of their cancer outside the eye. The     DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or     high risk (class 2) of spreading. This study is being done to collect information about how     physicians are using the DecisionDx-UM results to design individual treatment plans. It will     also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.   "
69437|NCT02376907|"     This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage     according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric     outlet obstruction (GOO) and the location of GOO.   "
69438|NCT02376894|"     The aim of this study is to examine the prevalence, severity, impacts and managements of CRF     among Taiwanese cancer patients.   "
69439|NCT02376881|"     Methanol poisoning could result in severe optic neuropathy, profound visual loss and finally     optic atrophy and permanent, irreversible optic atrophy and visual loss. Erythropoietin (EPO)     has recently emerged as a drug that may help retinal ganglion cell loss and improve optic     nerve function in some acquired types of optic neuropathy including traumatic optic     neuropathy ,ischemic optic neuropathy and optic neuritis .It has been found that EPO offer     some protection to the optic nerve and retina when they are injured and apoptosis process     starts in retinal ganglion cells. The standard treatments of methanol poisoning are     reanimation, metabolic stabilization, and inhibition of alcohol dehydrogenase by antagonist     agents and elimination of toxic metabolites in early phase of toxicity by dialysis. However,     after established optic neuropathy and visual loss there is little chance, if any, for visual     recovery and no definitive treatment exist for treatment in these cases. The investigators     recently reported the investigators preliminary results on 16 cases with methanol poisoning     and found a beneficial effect of systemic erythropoietin in methanol associated optic     neuropathy. Now, the investigators aim to investigate the effect of this agent in a clinical     trial.      The purpose of this study is to determine if EPO could improves optic nerve function and help     patients to improve visual recovery after methanol poisoning. Primary outcome measure would     be best-corrected visual function and secondary outcome measure is ocular coherence     tomography (OCT) measure of mean peripapillary nerve fiber layer thickness. Results of this     study could be very valuable in formulating an evidence-based management of Methanol     Associated Optic Neuropathy(MAON) and provide a high level evidence for changing the practice     on management of methanol poisoning . Also it could provide valuable data for neuroprotective     effects of erythropoietin specifically in neuroscience and ophthalmology.      The EPO-MAON trial is designed as a randomized, controlled, observer, and interpreter blinded     mono-center pilot trial with two parallel groups and a primary endpoint of best corrected     visual acuity during 120 days after enrollment into treatment groups.      All patients with methanol poisoning referred to Farabi hospital will be examined and     evaluated for best-corrected visual acuity, pupillary light reflexes, relative afferent     pupillary defect, color vision (Ishihara plates), fundus photography, slit lamp exam of     anterior segment and fundus exam with 78 D lens.   "
69440|NCT02376868|"     Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber     Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell Thickness between the     Maestro and iVue OCT devices.   "
69441|NCT02376855|"     The purpose of this study is to evaluate the implementation of an electronic consultation     model for specialty services (eConsults) to improve quality of care and reduce health system     costs. An eConsult is a non-face-to-face consultation between a primary care provider and a     specialist that takes place via secure messaging.   "
69442|NCT02376842|"     The investigators hypothesize that implementing an electronic health record-based early     warning system for severe infections (severe sepsis) will decrease the time to antibiotic     order. The study will consist of an algorithm which will monitor lab values, vital signs, and     nursing documentation for signs of severe sepsis. When these criteria are met, an alert will     be delivered via the electronic health record to a nurse and doctor and simultaneously an     alert via pager to another nurse. The investigators plan to randomize which patients will     generate these alerts and analyze the data after collecting information for approximately 6     months which will be sufficient to detect a 10% difference in the two patient groups.   "
69443|NCT02376829|"     To demonstrate that growing teenagers which present up to full cusp Class II malocclusions     can be treated using the Invisalign System.   "
69444|NCT02376816|"     The proposed phase I clinical trial is a pilot study to evaluate safety and biological     activity of the rAAVrh74.MCK.micro-Dystrophin vector administered by an intramuscular route.     This study will evaluated the micro-Dystrophin vector as a potential dystrophin replacement     mechanism for Duchenne Muscular Dystrophy. Two cohorts will undergo gene transfer in a     standard three-six dose escalation scheme to establish maximum tolerated dose (MTD) using     toxicity. A minimum of three subjects will be enrolled into each cohort. The first cohort     will receive a total dose of 3E11 vg. The second cohort will receive 1E12 vg total dose.   "
69461|NCT02376595|"     The purpose of this study is characterize the dose-effect relationship of rocuronium bromide     at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD)     model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular     blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis     muscle.   "
69752|NCT02372812|"     A randomised controlled clinical trial to assess the effect of intraoperative dexamethasone     on the 24 hour post operative pain scores of adult patients in Mulago hospital undergoing     mastectomies, laparotomies and thyroidectomies. The adverse effects of dexamethasone at this     dose were also assessed for.   "
69446|NCT02376790|"     The purpose of this study is to learn more about the role of etanercept alone or in     combination with methotrexate on disease activity in subjects with psoriatic arthritis.      To do this, etanercept alone will be compared to methotrexate alone or to combination     etanercept and methotrexate.This study will last approximately 1 year (52 weeks) for an     individual subject.      Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of     receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the     subject nor the study doctor can choose the group to which the subject will be randomized     into. Subjects will take one study medication by injection under their skin and a second     medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates the     subject and determines that their condition has not improved, the subject may qualify to     receive etanercept plus methotrexate.   "
69447|NCT02376777|"     Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K     antagonist (VKA) in real practice remain uncertain.      The few existing ambulatory studies did not answer all NOAC specific issues, such as     prescription habits and motives, patients characteristics, biological monitoring, as well as     the occurrence of major and minor thromboembolic events, especially in France where warfarin     is less frequently prescribed.      Therefore, in order to describe clinical and follow up characteristics of patients receiving     oral anticoagulants, the investigators will set up a national prospective cohort to compare     the occurrence of thromboembolic events between VKA and NOAC in primary care.   "
69448|NCT02376764|"     This study aims to deepen the investigators knowledge of Post Thrombotic Syndrome and MMPs     (and other related molecules such as TIMPS, NGAL and cytokines) to find a predictive     molecular system to better classify the risk of patients to develop a PTS after a DVT     episode, in order to monitorate more strictly the patients at high risk for developing this     complication.   "
69449|NCT02376751|"     This is an open-label, multicenter expanded access protocol to allow patients with a     confirmed diagnosis of Lysosomal Acid Lipase (LAL) Deficiency in the United States (US),     access to sebelipase alfa (recombinant lysosomal acid lipase [rhLAL]) until commercial     product is available.      Patients enrolled in the expanded access protocol will receive 1 mg/kg intravenous infusions     of sebelipase alfa every other week.   "
69450|NCT02376738|"     This study aims to evaluate the role of leukocyte activation in coronary artery disease   "
69451|NCT02376725|"     The purpose of this study is to determine if phacoemulsification with intraocular lens     implant (phaco/IOL) alone or combined with goniosynechialysis is better at controlling     intraocular pressure in subjects with primary angle closure.   "
69452|NCT02376712|"     The study aims to evaluate the diagnostic value of urinary indices in differentiating     pre-renal and renal acute kidney injury among critically ill patients.   "
69453|NCT02376699|"     This study will examine the safety profile of SEA-CD40 given alone and in combination with     pembrolizumab. The study will test increasing doses of SEA-CD40 given at least every 3 weeks     to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be     given to patients that does not cause unacceptable side effects. Different dose regimens will     be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and     antitumor activity of SEA-CD40 will also be evaluated.   "
69454|NCT02376686|"     The purpose of this study is to determine whether music hearing in the evening before going     to sleep can improve sleep quality, depressive symptoms and quality of life in patients with     affective disorders.   "
69470|NCT02376478|"     In this prospective, open, controlled, cross-sectional observational study patients with     psoriasis or IBD, who received either anti-TNF-alpha inhibitors or alternates (purine-, folic     acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were     included.      Anogenital HPV-induced lesions, mucosal HPV DNA and serological status of mucosal low-risk     (HPV6) and high-risk HPV (HPV16, HPV18) were determined.   "
69455|NCT02376673|"     This randomized controlled trial compares a specially-designed children's book to standard     brochures for safe sleep education and reduction of Sudden Infant Death Syndrome (SIDS) risk     in a high-risk population of young, first-time mothers enrolled in a home visitation program.     Roughly half of the mothers will receive safe sleep education via the book, the other half     via brochures, during prescribed home visits. Our study will assess differences in safe sleep     knowledge, adherence to recommendations, satisfaction with materials used, and attitudes     towards reading with their baby. Our hypothesis is that these will be higher in the group     receiving the book, due to simpler language, appealing illustrations, emotional connection,     and repeated exposures via shared reading.   "
69456|NCT02376660|"     A randomized control trial to assess the effect of oats on lipid profile of mildly     hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day)     in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of     soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In     total 3 assessment visits of the subjects planned for the study period.   "
69457|NCT02376647|"     This is a multicenter randomized controlled pilot trial to investigate the feasibility of a     driving pressure limited mechanical ventilation strategy compared to a conventional strategy     in patients without acute respiratory distress syndrome (ARDS).   "
69458|NCT02376634|"     The purpose of this randomized controlled study is to test the feasibility of clinical     hypnotherapy as a perioperative intervention for the reduction of pre-operative anxiety,     post-operative pain, and other-related symptoms (nausea, vomiting, spasms, length of stay,     self mastery) in children undergoing scoliosis repair or Nuss procedure.   "
69459|NCT02376621|"     The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted     conditions in healthy adult subjects. Each subject will participate in 5 treatment periods.     The order of treatments will be in accordance with the randomisation schedule.There will be a     minimum of 4 treatment-free days between each treatment period. On each dosing occasion,     subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing.     Twenty-four subjects will be enrolled to complete dosing of 20 subjects.   "
69460|NCT02376608|"     The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041     with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80     mg EPA and 50 mg DHA per gram oil) in healthy subjects.   "
69462|NCT02376582|"     The primary objective of the proposed phase I trial is to evaluate the safety and     tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123     and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and     have shown to be safe and well tolerated, this is the first time the combination regimen is     being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The     secondary objective of the trial is to evaluate the effect of S. mansoni infection on the     immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen.     Successful vaccination against most viruses requires efficient Th1 response. There is     evidence that helminth infections skew the host immune system of human and animals to     T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that     helminth infected populations may not generate the desired immune responses to vaccines     designed to drive Th1-type and cytotoxic T-cell responses.      Furthermore, the influence of helminth infections on the development of protective antibody     responses remains unclear. Limited data in animal models suggests that worm infections     reduced efficacy of vaccines.      The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a     vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine     (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine     trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune     responses to HIV vaccines.   "
69463|NCT02376569|"     This study intends to collect self-reported information with multiple surveys about lifestyle     habits, food and drink, state of mind (happy, sad, etc.) and traits (decision making, general     personality, etc.) The purpose of this study is to understand relationships between     self-reported information, game performance, and passive physiology measures throughout a     daily cycle.   "
69464|NCT02376556|"     The investigators aim to assess the effect of blepharoplasty with or without muller muscle     resection on the symptoms of dry eye syndrome. this will be an observational study in which     patients undergoing the aforementioned surgeries will be followed up and monitored for dry     eye symptoms.   "
69465|NCT02376543|"     Comparison Study between 19 gauge EUS FNA BNX Needle vs. 22 gauge EUS FNA BNX Needle in     Pancreatic Fiducial Placement To Treat Pancreatic Cancer   "
69466|NCT02376530|"     The purpose of the research is to examine the association between price changes, nutrient     profiling, and grocery food purchases among household grocery shoppers.   "
69467|NCT02376517|"     The purpose of this study is to test the effectiveness of a sun protection education program     for children of all ethnic and racial backgrounds. Practicing sun protection in childhood can     reduce the likelihood of developing skin cancer as an adult. The educational program consists     of a read-along book in English and Spanish for the child to read with the parent or     caregiver, text message reminders to practice sun protection, and a sun protective swim shirt     for the child.   "
69468|NCT02376504|"     The primary objective of this project is to determine the effects of decreasing sedentary     behavior at work by at least 3hrs/day using treadmill (walking and standing) and sit-to-stand     (standing only) workstations on the health of overweight office workers.   "
69469|NCT02376491|"     This trial will compare innovating stimulation parameters, intermittent Theta Burst     Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral     prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both     treatment conditions. The study seeks to determine if there is a superiority in therapeutic     efficacy with iTBS protocol compared to conventional one.   "
69475|NCT02376413|"     Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast     cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique)     could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as     traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs.     traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the     investigators are going to address this issue by assigning patients into traditional and     oncoplastic-BCS group, based on their preference.   "
69476|NCT02376400|"     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and     Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult     participants.   "
69477|NCT02376387|"     The proposed research will provide evidence-based strategies for the evaluation and     acceptance of donor hearts for transplantation. This is relevant to public health because     judicious expansion of donor hearts used for transplantation will make this life-saving     procedure available to a larger number of patients living with end-stage heart disease.   "
69478|NCT02376374|"     The investigators propose to study both inter- and intra-household Oral Polio Vaccine (OPV)     transmission in a primarily inactivated-polio vaccine (IPV)-vaccinated community in Mexico.     The investigators will enroll 3 distinct clusters of households in a municipality in Orizaba,     Veracruz, Mexico prior to the February 2015 National Immunization Week (NIW.) These clusters     will be physically separate from one another and differ only in the proportion of     OPV-eligible children who will receive OPV during the February 2015 NIW (10%, 30% and 70%     vaccinated.) The investigators will look at inter-household and intra-household transmission.     The investigators will then determine if epidemiologic (i.e.: degree of contact),     anthropometric (i.e.: nutritional status) or clinical covariates (i.e.: IPV/OPV immunization     history) are associated with intra-household transmission.   "
69479|NCT02376361|"     The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis     treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the     development of dialysis access thrombosis (clotting).      Investigators would like to study if monitoring with a specific technique called ultrasound     dilution technique can help prevent problems with access when compared to what is the current     standard of care for patients.   "
69514|NCT02375906|"     Hepatitis delta is a major health problem, not only because of the severity of the disease,     but also due to the lack of effective antiviral treatment. To improve the current therapeutic     options, a better understanding of the pathophysiology is essential. Reliable research in     this direction is only possible with large patient study groups. However, given the     geographic distribution of hepatitis delta, larger patient cohorts would only be possible     through multicenter collaboration.   "
69480|NCT02376348|"     Tanzania launched a National Strategy for scaling-up voluntary medical male circumcision in     2010, and aims to circumcise 2.8 million males by 2015. In September 2009, Jhpiego's Maternal     and Child Health Integrated Program (MCHIP) launched a PEPFAR-funded voluntary medical male     circumcision (VMMC) program which has circumcised over 110,000 males in Njombe and Iringa     regions by June 2012. In line with the national strategy, the target age for the program was     10-34 years, but 80% of clients were aged 10-19 years. There is an urgent need to increase     the proportion of older men (aged 20 years and above) who become circumcised, to have     greatest impact on the HIV epidemic.   "
69481|NCT02376335|"     Primary Biliary Cirrhosis (PBC) is a liver disease that predominantly affects females, can     present for the first time at any age and which develops over many years. It is caused by the     immune system attacking the body's own tissues. People with PBC frequently experience     profound fatigue or tiredness which they liken to their batteries running down and although     people still want to undertake normal activities they often lack the energy to be able to do     them. This reduces quality of life, makes it difficult for people to work and can end up with     them becoming isolated in the community. At present the investigators have no treatment for     fatigue in PBC. Finding a treatment for fatigue in PBC is one of the highest research     priorities identified by patient groups.      The aim of this study is to undertake a clinical trial to examine the effects of a treatment     (Rituximab) on severe fatigue in PBC to help us understand whether this will be a     potentially useful treatment. The information that this will give us about how energy     generation changes in patients with PBC with and without the treatment will also help us to     develop new treatments for fatigue in other diseases. The study has the potential to improve     the quality of life of many patients with PBC, for whom there is currently no hope of     improvement.      The investigators will perform a randomised controlled study of Rituximab therapy in PBC     compared to placebo (1:1 ratio).      The study will be performed in a specialised clinical research environment at Clinical     Research Facility Royal Victoria Infirmary. The investigators have, for many years, worked     closely with PBC patient groups to focus on the problems that are important to our patients.     This study is fully supported by Liver North, a liver disease charity and patient support     group.      The study will take place over one year and will involve between 9 and 20 visits although a     number of these will be telephone visits. Blood tests and quality of life questionnaires will     be performed at the start of the study and after three, six, nine and twelve months. At     baseline and 12 weeks follow up physical activity will be monitored using monitors, and an     exercise test and MRI scan will be performed.   "
69482|NCT02376322|"     Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients     with complicated bone metastases and have a low potential for severe treatment-related     toxicities. There is a clear need for hypofractionated schedules in the complicated bone     metastases population, especially when considering the overarching aim of palliative     radiotherapy and the clinical features of this patient population. As well, current research     examining hypofractionated approaches in bone metastases patients with impending or     pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly     scarce.   "
69483|NCT02376309|"     A decrease in muscle mass can have a profound impact on quality of life, as it can lead to     decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this     study we investigate whether ingesting leucine or getting a ND injection will reduce the loss     of muscle mass and strength.   "
69484|NCT02376296|"     In this observational study, blood samples for pharmacokinetic (PK) testing will be collected     from subjects with metastatic prostate cancer during their treatment with docetaxel. Plasma     levels of docetaxel will be determined, and the subjects docetaxel exposure levels,     determined as an area under the curve (AUC), will be retrospectively correlated with reports     of toxicity, tumor response, quality of life, time to disease progression and overall     survival to provide guidance on what the appropriate target range for docetaxel exposure     should be for metastatic prostate cancer subjects receiving docetaxel therapy for their     disease.   "
69492|NCT02376192|"     This is a study of pregnant women undergoing a cesarean delivery. It will compare their     microcirculation before and after the anesthetic. Microcirculation means blood flow to the     extremely small blood vessels in the body. It will also look at the differences in     microcirculation of participants who receive an infusion of phenylephrine compared to     participants who don't. The investigators hypothesize that spinal anesthesia will reduce the     vascular density and proportion of perfused vessels.   "
70254|NCT02366208|"     This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1     (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from     Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with     chronic hepatitis B.   "
69485|NCT02376283|"     Major heart attacks are caused by a numerous factors, including sudden clot formation in a     coronary artery leading to a blockage and heart muscle death. The clots are largely made of     sticky clotting blood cells (platelets). A patient having a major heart attack is treated     with emergency primary percutaneous coronary intervention (PPCI) where a wire and balloon are     used to reopen the coronary artery and a stent (a slotted metal tube) is placed to keep the     artery open.      Aspirin, and one of two other antiplatelet drugs (prasugrel or ticagrelor) are given prior to     PPCI to prevent further clots formation. Both antiplatelet drugs are taken in tablet form and     in healthy stable patients these drugs take at least 30 min to 2 hours to exert an adequate     effect. Often PPCI procedures are performed well within this timescale. It is possible that     having a major heart attack limits the bodies ability to absorb the drugs also.      In this study, patients with major or minor heart attacks will be given either prasugrel or     ticagrelor as per licensed indications and guideline recommendations. A 15 ml blood sample     will be taken at first balloon inflation to reopen the blocked artery, then after 20 minutes,     60 minutes, and 4 hours after taking the drugs. Each blood sample will be subjected to a     variety of tests to determine antiplatelet drug activity.      This study will identify which of the two agents used are working effectively during PPCI,     given the very short timescales involved. It will also show if patients with major heart     attacks absorb the drugs less well than patients with less severe heart attacks. In the     future it might be that an intravenous agent will be more valuable in the setting of PPCI.   "
69515|NCT02375893|"     The purpose of this study is to describe the composition of bile acids and the gut microbiota     comparing two populations: patients with coronary atheroma and the healthy subjects.      Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory     effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.   "
69516|NCT02375880|"     DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and     is being developed as an anti-neoplastic agent. This study is designed to evaluate the     safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination with     gemcitabine and cisplatin in patients with carcinoma primary to the intra- or exta-hepatic     biliary system or gallbladder.   "
69486|NCT02376270|"     The population is aging worldwide, which requires more attention to health needs and leads to     a dramatic increase in health care costs. Prevention or delay of onset of disorders     associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have     beneficial effects on gut health parameters, i.e. intestinal barrier function, immune     function and microbial composition. As intestinal barrier function may be compromised in the     elderly we will investigate whether the effects of pectin on selected parameters of gut     health differ between young vs. older individuals. The primary objective of this study is to     investigate the effects of aging on pectin-induced changes in intestinal permeability.     Furthermore, this study has seven secondary objectives. This study conforms to a randomized,     double-blind and placebo-controlled design including two parallel arms.The study population     consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30     kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A     second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before     and after the supplementation period, several measurements will take place. The main study     parameter is the change in urinary sugar excretion ratio before and after the intervention     period.   "
69487|NCT02376257|"     Despite advances in both pharmacotherapy and psychotherapy for major depression, non-response     and partial-response remain relatively common outcomes, motivating the search for new     treatments. This study is concerned with the development of one such novel treatment, the     augmentation of exposure-based cognitive-behavior therapy (CBT) with d-cycloserine (DCS).   "
69488|NCT02376244|"     Cardiac rehabilitation is a program designed to help patients regain good health through     lifestyle change after a heart attack, heart surgery or other heart problems. Patients will     take part in exercise sessions and education lessons, tailored to meet their personal needs.     The exercise training component of cardiac rehabilitation may be delivered as intervals of     short intense sessions (also known as high intensity intervals) or the current standard care     of longer but less intense sessions (moderate intense intervals). Both exercises have been     shown to increase fitness levels and also prevent future risk of heart disease.      The purpose of this study is to determine the efficacy and safety of high intensity interval     exercise training (HIIT) in patients who had a recent cardiac revascularization procedure or     recovering from a heart attack, in comparison to current standard of moderate intensity     exercise training in terms of their physical fitness and psychological well-being.   "
69489|NCT02376231|"     Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of     pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix)     and any other tissues involved with cancer. Several studies worldwide have reported that     women survive longer and enjoy a longer disease free interval before their disease returns if     all visible disease is removed at the time of their surgery. Achieving this is not easy and     often there is widespread disease and the surgeons are unable to remove every tumour nodule     present as it is attached to the surface of the bowel, diaphragm and other important     Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is     commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is     heated, it partially or wholly ionizes resulting in high energy particles like ions,     electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine     jet of neutral argon plasma from the handpiece that has been shown to have the ability to     vaporise nodules close to sensitive organs like the bowel. It may offer the potential to     treat the tumour nodules close to sensitive areas like the bowel. There have been no studies     exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be     used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of     tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and     ablation. It is similar to conventional surgical devices that are routinely used (called     diathermy) to achieve these effects. The PJ however is slightly different in that it may also     be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery     though the full extent of this role remains unclear.   "
69490|NCT02376218|"     It is common practice to leave a chest drainage catheter after lung surgical resections to     manage air leaks. The air leakage will usually stop in the initial postoperative days, but in     a few patients, it will last for a longer period of time, preventing the removal of the chest     tube that can lead to patient discomfort, increased likelihood to develop postoperative     complications and longer length of hospital stay. Pleurodesis is an effective method to     address postoperative air leak which consists in injecting an irritating solution into the     chest cavity. This is not performed regularly after lung resections for different reasons     including associated pain, costs, and fear of infections. Pleurodesis with hyperosmolar     glucose solution have been used for years with good results in some Asian countries because     of its simplicity and low cost. Its effectiveness for pleurodesis has been reported in cases     of spontaneous pneumothorax and chylothorax, but its efficiency to stop air leaks in the     postoperative period remains to be defined.   "
69491|NCT02376205|"     The main objective of this study is to analyze the effects of local anesthetic application     into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence     rates in patients undergoing anterior cervical discectomy and fusion.   "
70638|NCT02361164|"     The primary objectives are to evaluate relationship between nasopharyngeal microbial     colonization and the occurrence of AOM or pneumonia in infants.   "
69493|NCT02376179|"     We have devised a simple method to continuously measure the endotracheal tube cuff pressure     (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the     operating room to monitor arterial or central venous pressures. We have previously confirmed     both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement     of the IPMS readings with the values obtained from a standard manometer (gold standard). In     the current study, we will prospectively evaluate the relationship between the patient's head     position and CP in patients undergoing otolaryngological surgery and also measure the oxygen     and nitrous oxide saturation in the oropharynx.   "
69517|NCT02375867|"     Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The     mortality rate may reach 80-90% in the absence of liver transplantation. Liver injury is     considered to be mainly immune mediated with augmentation of cytolytic pathways of infected     hepatocytes. For that, it is suggested that corticosteroids modulate the activity of the     disease by suppressing the immune system.   "
69589|NCT02374931|"     This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron     emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors.     18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives off     radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may     show where tumor cells with estrogen receptors can be found in the body.   "
69494|NCT02376166|"     Clinical trials are critical to informing the care of patients with cancer. However, only     3-5% of patients with cancer enroll in clinical trials. Poor accrual to trials has major     implications with regards to the pace of progress, the cost of clinical cancer research, and     the generalizability of results. The investigators have recently shown in an analysis of     7,776 cancer clinical trials registered on clinicaltrials.gov that approximately 20% of     cancer clinical trials fail to complete enrollment at all; the most often cited reason was     poor accrual.      Prior research has identified barriers to cancer clinical trial accrual that can be generally     categorized in the domains of availability, awareness, and acceptance. Much attention has     been paid to the barriers involvement awareness and acceptance - however, trial availability     is likely a rate limiting step. This pilot study is the first in a series of planned steps     to attempt to shift the current paradigm of bringing patients to trials to bringing trials     to patients. With the integration of telemedicine visits, the investigators aim to decrease     the burden of participation for patients, begin to address geographic barriers, and     ultimately improve trial accrual. In this study, men with biochemically recurrent prostate     cancer (a rising PSA after definitive local therapy) will receive the antidiabetic drug,     metformin. Patients will require a single on-site visit for study enrollment. The remainder     of the 6 month study will be conducted via a HIPPA secure telemonitoring system (monthly     visits conducted via telemedicine with tablet computers provided to each patients).   "
69495|NCT02376153|"     This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier     System device reduces the incidence of surgical site infection after total hip replacement,     acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.   "
69496|NCT02376140|"     Sorghum is the primary source of food for more than 300 million people in arid and semi-arid     regions of Africa. The grain is one of the few crops that grow well in arid climates, but has     a low content in most essential nutrients and is difficult to digest. The African     Bio-fortified Sorghum (ABS) Project, a consortium of nine institutions led by Africa Harvest     Biotech Foundation International, is working to develop new varieties of sorghum that are     easier to digest and contain lower levels of phytates to improve the bioavailability of     micronutrients.      In order to determine their target levels, the ABS project needs reliable information on     current levels of micronutrient deficiency and consumption patterns of sorghum and nutrients     of interest, e.g. iron, zinc, and vitamin A in women and preschool children, which are not     currently available in Burkina Faso.      A background nutrition survey among children and women, comprised of two rounds, one in the     lean season (July - August) and one in the harvest season (November - January), has been     conducted to provide quantitative estimates of sorghum, vitamin A, iron and zinc intakes by     women and young children from two rural provinces of Burkina Faso. The survey also had a     biochemical component which included blood collection and analysis for indicators of     deficiency for vitamin A, iron and zinc. Other important components of this study included     anthropometric measurements, household and child morbidity questionnaires, and collection of     sorghum samples for analysis of phytate, vitamin A, iron and zinc content.   "
69497|NCT02376127|"     The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced     Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the     spine. The study aims to see if using these methods will help better see response to     treatment with radiation in patients with spine metastases from any solid cancer.   "
69498|NCT02376114|"     Glaucoma is one of the leading causes of blindness. Ginkgo biloba may be part of an effective     treatment strategy for glaucoma because it has been shown to improve blood flow, it has     antioxidant properties, it can relax smooth muscle, and it can protect neurons from damage.     The goal of our study was to determine whether Ginkgo biloba would result in increased ocular     blood flow which may protect against glaucoma damage.   "
69499|NCT02376101|"     The purpose of this current study is to evaluate whether the size of the endotracheal tube     (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If     there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be     inherent risks associated with the use of a cuffed endotracheal tube that is less than the     appropriate size. The investigators believe that the size of the tube chosen has an impact on     the characteristics of the inflated cuff and hence the intracuff pressure and the sealing     pressure are variable.   "
69500|NCT02376088|"     Patients with GD often present with glucose dysregulation, which, according to most studies,     is associated with islet β-cell dysfunctions, enhanced gluconeogenesis and insulin resistance     (IR). Current studies focus mainly on IR, and a few that investigate islet β-cell functions     show inconsistent results. This study examined the characteristics of glucose dysregulation     in Chinese patients with GD, and furthermore evaluated the effects of thyroid dysfunction on     islet β-cell functions and subsequently the carbohydrate metabolism.   "
69501|NCT02376075|"     A recent study with the DPP-IV inhibitor Linagliptin showed an improvement in the urinary     albumin creatinine ratio in patients with diabetic nephropathy. Gutzwiller et. Al. have shown     that GLP-1 increases renal Na secretion and inhibits renal H secretion, further indicating     some direct renal effects of GLP-1.      Therefore, it seems likely that treatment with the DPP-IV inhibitor Linagliptin evolves     several beneficial effects on microvascular and endothelial function beyond glucose control     which most probably have an impact on the progression of renal and retinal microvascular     disease.      The objective of this trial is to investigate the effect of Linagliptin in comparison to     placebo on the UACR in patients with high blood pressure and an increased albumin excretion.     Numerous, equivalent endothelial, renal, and retinal parameters serve as objectives of the     study. All study parameters will be handled in an exploratory sense for the generation of     models to further discuss the role of DPP-IV inhibition on renal and retinal physiology.   "
69518|NCT02375854|"     The objective of this protocol is to investigate the impact of prematurity, with or without     associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by     establishing a patient registry and biorepository. Serum and urine samples will be collected     serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert     Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up     and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to     a comprehensive clinical database.   "
69502|NCT02376062|"     Mental healthcare is severely neglected in resource-limited countries, including Nepal.     Nepali clinicians typically spend little time during their clinical education on mental     diseases. The authors conducted a needs assessment of Primary Care Providers (PCPs) at a     district level hospital in Nepal using focus group discussions, which revealed clinical     deficiencies in providing mental healthcare. The authors will develop and implement     computer-based educational modules to provide training in mental health for Nepali PCPs.     Effectiveness of PCPs' comfort level, knowledge and skills in evaluating, diagnosing and     managing mental illness will be assessed by administering pre- and post-tests. Acceptability,     feasibility and PCPs' comfort-level with the educational modality will also be assessed. Data     from the tests will be analyzed using paired t-tests. Additionally, data from the focus group     discussions will be further analyzed to assess for themes that might be common among PCPs in     other parts of rural Nepal, or regions where access to psychiatrists is very limited.   "
69503|NCT02376049|"     An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical     Agents in Adults with Mild to Moderate Atopic Dermatitis.   "
69504|NCT02376036|"     The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010     intravenous (IV) infusion in healthy adult volunteers.   "
69505|NCT02376023|"     The purpose of this study is to evaluate the implementation and effectiveness of text     messages as a means for improving adherence to cervical cancer screening.   "
69506|NCT02376010|"     Current oral anti-coagulation for atrial fibrillation is most commonly performed with     warfarin. Warfarin is a vitamin K antagonist that has been shown in non-randomized trials to     increase vascular calcification. Increased vascular calcification has been tied to increased     cardiovascular events (CVE). This study will randomize patients currently taking warfarin to     either continue on warfarin or be switched to rivaroxaban. Rivaroxaban is an oral     anti-coagulant that works by inhibiting Factor Xa, and has no interaction with vitamin K.     This study is a randomized, open label study that will randomize 120 patients and have them     undergo blood tests and a calcium scan at baseline, and again after 12 months. Patients will     be seen quarterly for examinations, safety checks and supply of rivaroxaban, as well as     follow up INR testing for warfarin.   "
69507|NCT02375997|"     The majority of patients with newly diagnosed metastatic ESCC and gastric cancer patients     experience a number of physical and psychosocial symptoms related to their cancer. Those     patients endure the greatest level of distress from their disease relative to other cancer     populations in China. Although new drugs have been applied in recent years, the median     overall survival time of metastatic ESCC and GC patients are still around 12 months.     Therefore, it is essential to maximize their quality of life (QOL) from the time of     diagnosis. Multiple studies demonstrate that symptoms such as pain, fatigue, and anorexia are     prevalent at diagnosis and worsen over time. As a result, suffering increases throughout the     course of the illness. To be most effective, palliative care with intensive symptom     management and psychosocial support should begin at the time of diagnosis, not once     life-prolonging therapies have failed. And some studies have revealed that early palliative     can even prolong the overall survival time in advanced lung cancer. The investigators then     initiated a randomized phase III clinical trial with standard oncology care plus early     palliative care or not in metastatic esophageal carcinoma and gastric cancer to observe     whether the early palliative can improve the QOL and even prolong the overall survival time     in those patients   "
69508|NCT02375984|"     The purpose of this protocol is to determine whether autologous TIL infused in conjunction     with systemic high-dose IL-2 after non-myeloablative chemotherapy with cyclophosphamide and     fludarabine can cause consistent and durable objective responses in patients who have     metastatic melanoma at the John Wayne Cancer Institute (JWCI).   "
69509|NCT02375971|"     The purpose of this study is to determine if intravitreal ranibizumab is superior to laser     ablation therapy in the treatment of retinopathy of prematurity (ROP).   "
69510|NCT02375958|"     A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.   "
69511|NCT02375945|"     Swelling is a common problem after knee arthroplasty often leading to delayed wound healing,     lasting functional impairment and hematoma.      Due to this complications, sometimes the risk for deep venous thrombosis is raised. This     study investigates a new self adjustable device to reduce swelling more effective     postoperatively. The investigators compare the new device to the current general practice by     using a standard class 1 elastic stocking   "
69512|NCT02375932|"     Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient     and provider priorities during primary care visits represents a barrier to effective primary     care. The investigators propose to design, implement, and evaluate in a randomized clinical     trial a web-based tool linked to the electronic health record (EHR) that will enable complex     patients to easily define care priorities for their upcoming visit.   "
69513|NCT02375919|"     The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and     tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED)     amongst low risk patients. Even though meta analyses have confirmed the safety of its     utilization, equipoise remains - especially in European country where the prevalence of PE is     higher than in the US- on whether this rule could be safely applied to all low risk emergency     patients with a suspicion of PE.      The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit     patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of     PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months,     and PERC based strategy for 6 months.      In the control group (usual strategy), patients will be tested for D-dimeres, followed if     positive by a Computed Tomography of Pulmonary Artery (CTPA).      In the intervention group (PERC Based), patients will be first assessed with PERC score. If     PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If     PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.      The primary outcome is the failure percentage of the diagnostic strategy, defined as     diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom PE     has been initially ruled out.   "
70255|NCT02366195|"     The study is a phase 2, multi centered, single arm study designed to evaluate the correlation     between CD8+ cell density and objective response rate in subjects with unresected stage IIIB     to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of     talimogene laherparepvec.   "
69520|NCT02375828|"     The understanding of the molecular mechanisms of neonatal diabetes has deeply changed the     therapy of patients carrying mutations in the K-ATP channel. Indeed, those patients are not     treated anymore by insulin injections but by glibenclamide an oral anti-diabetic drug widely     used in type 2 diabetes. Anyway, its galenic form (pills of 5 mg) is not suitable for     children and difficult to administrate to infants or young children. The purpose of this     study is to determine if a new galenic form of this durg is more suitable and as efficient as     pills in children with neonatal diabetes.   "
69521|NCT02375815|"     This study is designed to answer a key question in the field of implementation science.     Specifically, it seeks to determine if a proposed model for the implementation and scale-up     of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the     potential of this model, the investigators will conduct a multi-year study comprising 3     phases. This proposal represents the first of these phases.   "
69522|NCT02375802|"     This pilot study of 12 patients (6 control, 6 experimental) will test the safety and efficacy     of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or     IV pressure ulcer. Patients in both groups would undergo a minimal risk liposuction procedure     to withdraw 50-100 cc of adipose tissue. The tissue would be processed to extract the stromal     layer of cells that contain stem cells. The ASCs would be injected into a fibrin sealant to     be applied to the wound. Patients would be followed for 6 weeks to assess wound healing and     tolerance of the treatment.   "
69523|NCT02375789|"     This study will be a randomised placebo controlled trial examining the effectiveness of using     an intranasal cooling device (the RhinoChill) in providing relief of pain and symptoms of     acute migraine. It will involve using two nasal catheters to cool the nasal cavity which     provides localised cooling of the local nasal tissue and the blood vessels which supply blood     to the brain. This cooling effect will cause the blood vessels to constrict as well as     stimulating special cold receptors that are thought to be involved in the relief of migraine,     thereby providing both pain and associated symptomatic relief. Ninety patients will be     randomised in a 1:1 fashion, clustered to three different recruitment sites. The patients     will have a 30 day period of data collection for their current migraine frequency, treatment     and response to medication (with a minimum of 2 migraine attacks recorded) before starting     the treatment phase with the RhinoChill Device. Treatment will be for 2 migraine attacks.     Only a single treatment is allowed for the first attack, but on the second attack the patient     may deliver 2 treatments with a gap of at least 2 hours between treatments.   "
69524|NCT02375776|"     This study evaluates a smart phone based mobile application designed for patients with Renal     Cell and Prostate Cancer taking oral anti-cancer medications. (OAMs) All participants will be     patients at the Dana Farber Cancer Institute in Boston, Massachusetts. Half of the     participants will use the mobile application for a 3 month period along with their usual     care. Half of the participants will just receive usual care.      The investigators hope to show that cancer patients taking OAMs who use the mobile     application will be better connected to their care team and will develop increased competency     for self-care which will primarily increase medication adherence.   "
69525|NCT02375763|"     Children will be recruited from the pediatric dentistry clinic of Marquette University at     their first or recall appointment and will be asked to fill a questionnaire regarding their     dietary habits. Afterwards a dietary analysis will be performed using a computer software,     developed for this study and dietary instructions will be given to the children.   "
69526|NCT02375750|"     The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and     Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to     peri-implantitis disease.   "
69527|NCT02375737|"     The investigators propose to evaluate the implementation of an efficacious medication     adherence program in a group at high risk for CVD. The program involves patients     receiving/responding to e-reminders to take CVD medications via patient-selected technology     [mobile/web-based applications, short message service (SMS; text messaging), interactive     voice response (IVR), or e-mail] supported by a tailored, monthly, self-management program     administered by either research staff or a case manager staff member from the Duke Outpatient     Clinic via the telephone. This is a hybrid type II implementation science study.   "
69528|NCT02375724|"     The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID     compared with placebo on COPD symptoms in a symptomatic patients population with moderate     COPD and chronic bronchitis, and particularly assess the effects in cough by using specific     tools to assess the occurrence and impact of this relevant COPD symptom.   "
69529|NCT02375711|"     The aim of this study is to investigate the role of immunosenescence in the HBV vaccination     response in patients with renal insufficiency.   "
69530|NCT02375698|"     This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity     study in adults who have recently been successfully treated for drug-susceptible pulmonary     Tuberculosis (TB). The safety and immunogenicity profile of escalating doses of AERAS-456 in     HIV-negative subjects recently treated for drug-susceptible pulmonary TB will be     investigated. The study will be conducted at one or more sites in South Africa.   "
69531|NCT02375685|"     The objective of this study is to evaluate long-term safety of gevokizumab in patient with     chronic non-infectious uveitis who previously well tolerated the study drug and may benefit     from longterm treatment with gevokizumab.   "
69532|NCT02375672|"     This is a multi-institutional, single arm, open-label, phase II study, including a safety     run-in cohort. No randomization or blinding involved.   "
69544|NCT02375516|"     The planned research aims to delay the onset of drug use and reduce harmful use and abuse     among Hispanic youths. The culturally-tailored prevention program will be delivered to youths     by computer. Over 5 years, the program will be developed and tested in a randomized clinical     trial. The intervention program will include 10 initial sessions, followed by annual booster     sessions. Outcome measurements will involve baseline, post-intervention, and three annual     follow-up data collections.      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower     among participants assigned to receive the intervention. If proven to be efficacious, the     program will be revised and disseminated nationally.   "
69533|NCT02375659|"     Across the U.S. Skin of Color (SOC) clinics have been established with the goal of providing     medical care and supporting research related to patients with skin of color. There have been     no formal studies evaluating why patients seek medical care at SOC clinics or treatment     outcomes. Reasons may include past experiences with other providers, the perception that     providers working in these clinics have a special interest or knowledge in caring for     patients with skin of color and thus may provide better care, the expectation of cultural     sensitivity, the hope that their provider may have a similar ethnic background, and/or ease     of communication with their provider. Through focus group discussions we aim to identify the     factors influencing a patient's choice to seek medical care at a SOC clinic and to gain     insight into the presence and impact of racial concordance between provider and patient. The     current study will focus on self-identified African American patients with interest in     conducting similar sessions with patients of other ethnicities and races in the future.   "
69534|NCT02375646|"     One of the well-known of complications post colonic polypectomy is bleeding usually occuring     in the 2-week period following the procedure. Patients treated with oral anticoagulation     (e.g. Warfarin) are a special and challenging patient group due to the need on the one hand     to prevent thromboembolic events, and on the second hand to minimize the risk of     post-polypectomy bleeding. Current practice guidelines recommend holding Warfarin treatment     while bridging with LMW Heparin while resuming Warfarin treatment following the procedure.     This practice was found to be associated with a much higher rate of bleeding compared with     continuing Warfarin in a recent prospective trial in pacemaker transplanted patients. The     fact that most post-polypectomy bleeding occurs within the 2-week period further questions     the current practice of periprocedural bridging therapy. the investigators therefore     hypothesize that patients with continuous Warfarin treatment may have similar     post-polypectomy bleeding rates compared to patients receiving bridging therapy with LMW     Heparin.      This is a multicenter single-blinded prospective randomized trial comparing small     post-polypectomy (polyps<10mm) bleeding rates between two groups of patients: Continuous     therapy with Warfarin, vs. LMW Heparin therapy while withholding Warfarin therapy (current     practice).   "
69535|NCT02375633|"     A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical     Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain     Patients.   "
69536|NCT02375620|"     The study was evaluated as the optimal dose for the treatment of SGA short stature children     by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of     SGA short stature children and provided scientific, reliable basis for phase III clinical     trials for dose selection.   "
69537|NCT02375607|"     The purpose of this study is to determine the correlation between preoperative algometer     score and the amount of postoperative analgesic consumption. The algometer score of the     patients will be recorded in the preoperative period. In postoperative period, the analgesic     consumption rate will record and compare with the algometer score.   "
69538|NCT02375594|"     Exercise park equipments for the elderly are designed taking into account the physical and     cognitive capabilities and needs of elderly individuals. These equipments are usually built     in public spaces, and may be part of public health initiatives to promote active lifestyles     in the elderly.      Previous research has provided clear evidence on the short-term efficacy of exercise programs     in improving physical function and level of physical activity in community-dwelling elderly.     The goal of this randomized clinical trial is to assess whether an exercise intervention     conducted in an exercise park equipment is able to achieve sustained improvements in physical     function and level of physical activity, that are maintained for at least 3 months after the     end of the intervention. The target population are community-dwelling elderly that are     insufficiently active.   "
69539|NCT02375581|"     To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with     concurrent radiotherapy in older patients with esophageal cancer.   "
69553|NCT02375399|"     Echocardiography parameters for cardiac dyssynchrony had no predictive value in current     multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive     echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been     analyzed, but their definite value has not been proven yet.   "
70764|NCT02359526|"     To provide treating physicians with experience with ILUVIEN as well as monitoring its safety     (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged     insufficiently responsive to available therapies.   "
69540|NCT02375568|"     According to many recent research, mesenchymal stem cells (MSC) isolated from synovial     membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency     and ability to undergo chondrogenesis.      Based on this concept, the investigators plan to get two removed tissues (synovial membrane     and infrapatellar fat pad) from patients who have an operation of total knee replacement. The     investigators are going to isolate and expand MSC from these two tissues respectively, and     then compare the chondrogenesis ability for clinical application. In the other hand, the     investigators plan to build techniques and procedures which comply with Good Tissue     Practices (GTP)   "
69541|NCT02375555|"     This research study is evaluating a combination of four drugs -- lenalidomide, bortezomib,     dexamethasone and elotuzumab -- as therapy for newly diagnosed multiple myeloma.   "
69542|NCT02375542|"     This study will analyse factors contributing to cardiac re-operation to determine causative     effects   "
69543|NCT02375529|"     Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as     a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy     (LC) in terms of postoperative pain and faster recovery.      Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC     (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative     pain and analgesic requirements, success of the ambulatory process, return to normal activity     and return to work, cosmetic results and quality of life score.   "
69579|NCT02375061|"     This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible     Self, BPS) over optimism, future expectancies and positive affect at mid-term, in comparison     to a control group, in fibromyalgia patients. The principal hypothesis is that the BPS     intervention will enhance significantly the levels of optimism, positive future expectancies     and positive affect in comparison to the Control group at short and mid-term.   "
69545|NCT02375503|"     The primary objective of this randomized, double-blind, placebo controlled trial is to     determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified     food product on bone turnover markers, including parathyroid hormone (PTH) and     microarchitecture during Army basic military training (BCT). The investigators hypothesize     that consumption of a once daily calcium and vitamin D fortified food product will stabilize     PTH and contribute to improved bone microarchitecture compared to placebo. The results will     determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover     markers as well as provide novel data regarding microarchitectural changes during BCT as     assessed by high resolution peripheral computed tomography (HRpQCT) scanning.   "
69546|NCT02375490|"     Childhood obesity is one of the greatest challenges facing public health and recent evidence     shows it begins in preschool aged children. It has been suggested that interventions be     carried out to improve physical activity and healthy eating behaviour among young children.     This study aims to fully evaluate Healthy Start, a multilevel physical activity and healthy     eating intervention for preschool aged children. It is hypothesized that the Healthy Start     intervention will improve both eating and physical activity behaviors of children attending     early childcare centers because of its influence on multiple factors.   "
69547|NCT02375477|"     This clinical trial studies how well inter-disciplinary educational methods work in improving     adherence to isolation protocols in patients with Clostridium (C.) difficile infections. An     inter-disciplinary educational method may help to prevent the spread of infection.   "
69548|NCT02375464|"     Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron     emission tomography (PET scan). The material has already been shown to be better than the     currently available imaging agents. This study is designed to evaluate the clinical impact of     PET CT scanning using this agent in the evaluation and management of patients with NETs.   "
69549|NCT02375451|"     Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in     adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The     investigators goals are to answer this question by measuring salivary gland function before     and after I-131 administration in children who receive radioiodine therapy at our hospital     for thyroid disease.   "
69550|NCT02375438|"     The aim of this study is to assess nutritional intake (quantitatively and qualitatively),     nutritional state and body composition of patients suffering from mitochondrial cytopathy,     compared to healthy controls. The energy intake will be calculated through dietary protocols,     the energy expenditure by indirect calorimetry and body composition will be performed with     bio-impedance analysis. Further on, the investigators expect to be able to provide     nutritional counselling to this population in order to increase energy and protein intake,     which may improve health and well-being.   "
69551|NCT02375425|"     The development of surrogates to predict HIV prevention product safety and efficacy is a high     priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed     to rectally applied microbicides in vivo and then challenged with HIV in the lab showed     significant reduction in HIV replication when compared to tissue exposed to placebo gel.     Currently, the ex vivo challenge model for ectocervical and vaginal tissue is under     development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA.     Currently the Reproductive Infectious Disease Research Group is conducting a study designed     to answer important questions about the ex vivo challenge model:which HIV virus is the best     to use in the laboratory and what is the best indicator of HIV infection. The proposed study     delineated here will investigate the effect of BV, HSV and contraceptive use on the model .     There will be two arms to the study; the first will investigate the impact of HSV and BV     status and the second, contraceptive use. Vaginal and cervical biopsies will be collected     from participants for the ex vivo challenge model.   "
69552|NCT02375412|"     The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic     nervous system could complicate the postoperative course in the patient undergoing surgery.     Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the     autonomic nervous system.   "
70777|NCT02359357|"     To determine the safety and tolerability of single and multiple escalating doses of FDL169 in     healthy male subjects.   "
69554|NCT02375386|"     This is study testing the feasibility of collecting neurophysiological measures of outcome     related to body-based interventions for low back pain. The investigators will collect fMRI     and psychophysical data about pain sensitivity before and after the interventions.     Participants will be randomly assigned to either spinal manipulation or therapeutic touch     groups. Participants will attend two practice sessions prior to the first data collection.     There will be two follow-up assessments.   "
69555|NCT02375373|"     This prospective study will assess the effects of adding legumes, especially chick peas, to     the diet of healthy adults on the commensal bacteria from feces of human subjects and     resulting self-reported GI symptoms as well as markers of immune function.   "
69556|NCT02375360|"     Patients with food allergy and their parents will answer a food allergy quality of life     questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled     also by patients undergoing oral immunotherapy (OIT).   "
69557|NCT02375347|"     This prospective study will assess the effects of adding legumes, especially chick peas, to     the diet of healthy adults on the commensal bacteria from feces of human subjects and     resulting self-reported GI symptoms as well as markers of immune function.   "
69558|NCT02375334|"     This research trial studies an adherence monitoring system in managing myelosuppression in     patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation     therapy. The development of an adherence monitoring system may help doctors more effectively     utilize electronic medical records to manage myelosuppression during standard treatment with     temozolomide and radiation therapy in patients with malignant gliomas.   "
69580|NCT02375048|"     Selected patients with early stage breast cancer undergone conservative surgery were     randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial     Breast Irradiation.   "
69581|NCT02375035|"     To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of     undertaking prostate biopsy as part of their clinical management.   "
69559|NCT02375321|"     Many researches have shown that patients with Obstructive Sleep Apnea (OSA) and often also     the family members have a decreased quality of life, problems related to the sexual sphere,     depressive disorders and anxiety problems. To date still remains controversial the     relationship between OSA and quality of life, also the link between sleep apnea syndrome and     depression is unclear.      In adult patients with OSA the treatment of choice is the application of a continuous     positive airway pressure (CPAP: Continuous Positive Airway Pressure) at the opening of the     airways. With the CPAP treatment the sleep normalizes and daytime sleepiness fades or     disappears.      Many studies have shown that this treatment determines improvement of the medical and     psychological status. However, the rate of non-adherence to treatment reported in the     literature is about 46-83%, considering as adherence the use of CPAP for at least 4 hours per     night. A recent study has shown that CPAP used as a single treatment in patients with OSA and     depression, has reduced the depressive symptoms but in a significant percentage of patients     (42%), the depressive symptoms remained unchanged or worsened. At the present time have not     been published, to our knowledge, studies concerning the effectiveness of the combined     treatment of CPAP and psychological support on the mood and on the quality of life OSA     patients.      Therefore the aim of this study is to evaluate the effects of the combined treatment with     CPAP and psychological intervention with cognitive behavioural therapy on the mood and on the     quality of life of OSA patients.   "
69560|NCT02375308|"     The purpose of the study is to compare the efficacy of an Hypnotherapeutic Treatment of     Depression to Cognitive Behavioral Treatment of Depression in patients with mild to moderate     Major Depressive Episodes.   "
69561|NCT02375295|"     The aim of this research is to determine an effective antibiotic regimen following definitive     surgical therapy of kidney stones caused by bacterial infection (struvite stones).   "
69562|NCT02375282|"     Ambulation following surgery has been found to be beneficial for patients; however, nurses     and doctors struggle with getting post-operative, hospitalized patients to walk on their own.     One promising strategy to address this might be an ambulation orderly, an employee whose     single responsibility is to assure that patients walk 3-4 times per day. However, the effect     of the ambulation orderly on post-operative physical activity has not yet been described. It     is important to quantify what the ambulation orderly does in order to assess if this is an     effective method for helping patients walk. As a result, the investigators will perform a     pilot randomized controlled trial to test the effects of an ambulation orderly in patients     hospitalized with recent cardiac surgery. Half of the patients will be assigned to walk with     the ambulation orderly 3-4 times/day and the control group will be given standard nursing     encouragement and assistance and encouragement to walk. The investigators will evaluate the     average total daily step counts (over the hospital course, usually 4-7 days) and the change     in walking distance between a baseline and a final 6 minute walk test. The investigators will     also evaluate exercise physiologic parameters (heart rate, oxygen saturation) during     ambulation, patient functional independence, and patient satisfaction.   "
69563|NCT02375269|"     Remote Ischemic Preconditioning (RIPC) is mediated by intermittent brief episodes (5-10     minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. For this purpose in     3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes and     deflated for 5 minutes afterwards. The ischemic episodes are known to stimulate platelets and     factors platelet dependent factors such as Serotonin and VEGF. These humoral factors have a     systemic effect and have the potential to protect target organs (i.e. heart, kidney, liver)     remote to the ischemic limb.      The purpose of this randomized controlled study is to investigate the influence and impact of     RIPC on postoperative complications in patients undergoing visceral surgery   "
69564|NCT02375256|"     Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to     receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on     Study Days 0 and 28. Subjects were followed for a total of 98 days.   "
69565|NCT02375243|"     The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for     sedatives and analgesics in the immediate post-operative period in children who underwent     surgical correction of complex congenital heart disease   "
69577|NCT02375087|"     Up to one-third of patients with myotonic dystrophy type 1 die suddenly mainly from     arrhythmias. Sleep apnea is prevalent in myotonic dystrophy (DM1) patients. Among the serious     complications from sleep apnea, the most alarming are arrhythmias and sudden cardiac death     (SCD). Diagnosis of sleep apnea using simple tools in ambulatory cardiology practice may     improve therapy of cardiac arrhythmias in patients with DM1   "
76750|NCT02281227|"     To evaluate the effects of skin compression with an indicator at the needle entry point on     radiation exposure time of fluoroscopically guided transforaminal epidural block in obese     patients   "
69566|NCT02375230|"     Establishing breathing after birth is vital for survival and long-term health of premature     babies. 10% of all preterm babies fail to breathe after birth and require help with     breathing. When infants need help with breathing the clinical team will place a small mask on     the babies face to give some breaths to help the baby breath (what the investigators call     mask ventilation).      This procedure is done million times a day around the world and several times a day here at     the Royal Alexandra Hospital. Providing these breaths via mask ventilation is the most     difficult step in helping a baby breath at birth. If this is provided wrongly then baby does     not receive enough oxygen, which could damage the brain and even cause death.      To keep the skill level of every staff member up-to-date every staff member is required to     re-train this rescue breaths via mask ventilation once every two years.      The investigators believe this is not enough and that daily trainings are necessary to keep     your skills up-to-date.      The investigators aim to compare to different teaching techniques using daily trainings to     see if either improves the skills of the resuscitator providing mask ventilation      The study will last 7 month (baseline observations (2 months), intervention period (3     months), After trial period (2 months)      The investigators will use our routinely used equipment to record neonatal resuscitation and     the investigators also routinely make video recordings to evaluate performance during     resuscitation.   "
69567|NCT02375217|"     Prospective Randomized non inferiority Trial involving adult patients undergoing elective     surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose     sugammadex vs half dose sugammadex for reversal of NMB.   "
69568|NCT02375204|"     This randomized phase III trial studies how well standard-dose combination chemotherapy works     compared to high-dose combination chemotherapy and stem cell transplant in treating patients     with germ cell tumors that have returned after a period of improvement or did not respond to     treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin,     carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by     stopping them from dividing or killing them. Giving colony-stimulating factors, such as     filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the     bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to     prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the     patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not     yet known whether high-dose combination chemotherapy and stem cell transplant are more     effective than standard-dose combination chemotherapy in treating patients with refractory or     relapsed germ cell tumors.   "
69569|NCT02375191|"     The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to     ropivacaine in pediatric orthopedic surgery   "
69570|NCT02375178|"     This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of     chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the     oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to     control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile     saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed     to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to     polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth     with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of saliva     will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples will be     plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples will be     processed by a blinded microbiologist.   "
69571|NCT02375165|"     Acquired lymphedema is a disease that causes chronic swelling of the limb(s). It is     frequently under-recognized or misdiagnosed. This study is designed to lead to the     development of an accurate, noninvasive, blood test to allow testing for lymphedema.   "
69572|NCT02375152|"     Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a     worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of     pharmacological and behavioural treatment methods for most OCD patients, roughly one third do     not demonstrate significant symptom improvement, even after aggressive treatment (Foa et al,     2007). The effectiveness of neurosurgical treatment methods (including ablative surgery) for     those with severely disabling treatment resistant OCD is substantiated by clinical research     (Greenberg, Rauch & Haber, 2010). The brain target of this procedure is usually the area     between the anterior and middle third of the anterior limb of the internal capsule.   "
69573|NCT02375139|"     This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of     DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).   "
69574|NCT02375126|"     In this study, the investigators will collect EEG data in normal, healthy volunteers without     a history of prior brain injury. This data will be analyzed by computer (quantitative, or     qEEG) and stored in a normative database so that, in the future, the investigators can better     understand and characterize the brain damage that can result from carbon monoxide (CO)     poisoning and other types of brain injury.   "
69575|NCT02375113|"     This is a pilot study examining the effect of dietary supplements that contain soy products.     The purpose of this study to find out if soy supplementation can help to reduce the storage     of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the     abdomen; it has the potential to increase the risk of certain health problems.   "
69576|NCT02375100|"     This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve     block for postoperative pain in patients undergoing inguinal herniorraphy with spinal     anesthesia. One-third of the patients will receive standard postoperative pain     regimen(control group), one-third will receive a transversus abdominis plane block (with     ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with     ultrasound guidance) in addition to standard postoperative pain regimen. This study is a     Randomized prospective open-label controlled study.   "
70062|NCT02368743|"     This national, observational and multicentre study aims at establishing a picture of real     clinical practices management among patients treated with Pentasa®, according to the current     therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to     provide data on patients' health related quality of life, compliance and efficacy in real     clinical practice   "
69578|NCT02375074|"     Long-lasting sickness absence is a risk factor for permanent disability, and the share of     young workers falling into early disability is an increasingly important problem in Norway.     Early withdrawal or exclusion from the labor market leads to large individual and societal     costs. The SEED-trial is a randomized controlled trial aiming to provide evidence-based     knowledge about different approaches to prevent permanent disability and increase labor     market participation in this important and vulnerable group. The trial includes unemployed     individuals aged 18-29 years, and the participants will be randomly assigned to 1 of 2     interventions, both aimed at facilitating participation in working life:        1. Traditional Vocational Rehabilitation (TVR), offering training and preparation for the          labor market in a sheltered environment        2. Supported Employment (SE), focusing on competitive employment in real-life settings          without long-lasting preceding training      Both interventions are currently provided by The Norwegian Labor and Welfare Administration     (NAV). Supported Employment was introduced recently and is currently being implemented, while     traditional vocational rehabilitation with sheltered employment has been around for years.     However, no Norwegian controlled studies have been conducted on these practices in this     population. The current study will therefore provide new knowledge of the effect of     traditional as well as new and promising interventions to increase labor market participation     and prevent early disability.   "
69753|NCT02372799|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone     compared with placebo in pediatric outpatients (7-17 years of age) with major depressive     disorder.   "
69582|NCT02375022|"     This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin     (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC)     with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.     Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the     ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib     is more effective when given with rh-endostatin in NSCLC patients with EGFR activating     mutations.   "
69583|NCT02375009|"     This proposal aims to evaluate selective laser trabeculoplasty (SLT) as a safe and effective     therapy to control open-angle glaucoma and reduce the risk of progression to visual     dysfunction or blindness in the African-derived developing world. If funded, this work will     complete the characterization of SLT's safety and efficacy profile as a means of long-term     disease control in this population. This work will support the translation of SLT into a     structured public health initiative to reduce glaucoma-related vision loss throughout the     African-derived developing world.   "
69584|NCT02374996|"     Insulin is a hormone produced by the body to regulate blood sugar. Insulin resistance is a     state when the body is not using insulin correctly, and more insulin is needed to maintain     normal blood sugar. Insulin resistance is common in bipolar patients and even more common in     bipolar patients treated with antipsychotics. Insulin resistance from antipsychotics can lead     to type 2 diabetes, metabolic syndrome and cardiovascular disease and is known to lead to     worse psychiatric outcomes (less mood stability) and lower life expectancies in bipolar     disorder. Abnormal regulation of the folate cycle is known to play a role in     antipsychotic-induced insulin resistance and the main endpoint to the folate cycle is the     production of methyl donors for DNA methylation. DNA methylation is critical as it regulates     how genes are expressed. Thus, changes in DNA methylation may play a role in the disease     process of antipsychotic-induced insulin resistance. The purpose of this study is to examine     the differences in the DNA methylation of candidate tissues known to have a role in the     development of insulin resistance. The three groups of bipolar patients to be studied are 1)     antipsychotic treated patients with impaired glucose tolerance, 2) antipsychotic treated     patients with normal glucose tolerance and 3) lithium treated patients with normal glucose     tolerance. Group 1 will be compared to groups 2 and 3 in order to assess how DNA methylation     in the skeletal muscle and fat tissue changes due to medication effects (group 2 vs. 3) and     medication side effects (group 1 vs. 2). Secondary analyses include the analysis of how fats     are processed in skeletal muscle and fat tissue in relation to antipsychotic-induced insulin     resistance and the correlation of DNA methylation across different tissues. The investigators     hypothesize that antipsychotic-induced insulin resistance is to due changes in the way DNA is     expressed (through epigenetic changes) which causes further changes in the way fats are     processed in the body eventually leading to insulin resistance. This work is based on     preliminary findings however further work is needed to identify the true mechanisms behind     antipsychotic-induced insulin resistance and in particular, the main tissue in which this     mechanism occurs.   "
69585|NCT02374983|"     Gamma Knife Radiosurgery (GKR) is a well established treatment modality for brain tumors and     functional disorders of the brain. It relies on mathematical algorithms to predict dose     distribution and to calculate the dose at arbitrary points in the head. For the last 25     years, doses applied using Gamma Knife Radiosurgery have been calculated using a simple     algorithm, called the Tissue Maximum Ratio algorithm (TMR). Dose planning using this     algorithm, relies on a number of approximations to enable fast isodose computation during     treatment planning. One of the most significant of these is the approximation of the head to     water-equivalent density. The increased electron density of brain and bone (relative to     water) and the near-zero density of air cavities in the skull may make significant     perturbations to isodose and beam-on time calculations.      With the advent of faster workstations, the effect of tissue in-homogeneities can finally be     calculated in reasonable time during the treatment planning process; a newer, more modern     algorithm known as convolution algorithm is now commercially available. It uses the values of     density indicated in the CT scan to predict the dose distribution and is expected to more     accurately calculate radiation dose, although it needs further investigation before clinical     implementation. Inter- and intra-indication differences between the old and new algorithms     need to be understood before this method can be confidently employed in a clinical setting.     It is the aim of this study to understand the dosimetric differences between these dose     calculation algorithms and to evaluate the implications of using the convolution algorithm     for GKR. A large number of treatments will be re-planned using the convolution algorithm and     compared to the TMR plans used to treat the patients. Beam-on-time, which is proportional to     dose and a number of commonly used metrics for the targets such as coverage, selectivity,     gradient index, and mean and maximum dose, will be estimated with both algorithms. Subgroup     analysis will be done to assess whether any factor such as diagnosis, size of the head or     location of the target could impact on the relative difference between the methods. The     treatment plans will be compared and the potential implications on treatment planning will be     elucidated.   "
69596|NCT02374840|"     The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help     healthcare providers manage patient medication regimens and assess if the testing has an     effect on reducing medication side effects, hospitalizations and emergency department visits.      The way an individual processes a drug is in part determined by their genes, and there is     known to be genetic variation between humans in the way drugs are metabolized. The study of     the way genes affect a person's response to drugs is known as Pharmacogenomics.   "
69597|NCT02374827|"     To compare the feasibility and surgical outcomes between complete salpingectomy and standard     postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women     with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.   "
69586|NCT02374970|"     Low back pain is not a diagnosis; it is a symptom describing the presence of pain in the     lumbar vertebral or paravertebral region without any reference to the structure or cause of     the process. It is one of the most widespread diseases and one of the most common reasons for     visits in primary care setting.      Exercises to improve lumbar stability involving co-contraction of the transversus abdominis     have proved to be effective in reducing pain and improving function. It has been stated by     ultrasound images that specific stabilization exercises cause contraction of the deep     abdominal muscles, but it remains unclear whether training produce thickness muscle     improvement and if this improvement is related to clinical findings.      To try to resolve this issue a project of an experimental trial, double-blind (patient and     evaluator) with two groups randomly assigned is presented. All participants will be recruited     in an primary care center of the Catalan Health Institut and will sign informed consent. All     will receive a protocolized treatment with therapeutic exercises and thermotherapy and,     additionally, those assigned to the intervention group were instructed in performing lumbar     stability exercises.      Pain (VAS), function (Roland-Morris Questionnaire) and the thickness of the transversus     abdominis, internal and external oblique muscles (measured by ultrasound) at baseline, end of     treatment protocol (12 sessions) and three months after the end of treatment will be     assessed.      Results in pain, function, and its correlation with the mean changes in the thickness of     transversus abdominis will be analyzed.   "
69587|NCT02374957|"     Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm     (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the     treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to     collect quality of life data on patients undergoing peripheral revascularization in order to     determine the sample size required to adequately power a trial of Cilostazol versus usual     care without Cilostazol and its effect on quality of life.   "
69588|NCT02374944|"     This study is a multicenter prospective randomized control trial comparing hardware retention     (HR) to removal of hardware (RH).   "
69590|NCT02374918|"     Mild traumatic brain injuries (mTBI) or concussions are an increasingly prevalent injury in     the investigators society. Patients with post-concussion syndrome have been shown to have     deficits on tests of short term memory, divided attention, multi-tasking, information     processing speed, and reaction time, as well as alteration in mood and emotional functioning.     Many patients have other vague complaints including fatigue, dizziness, irritability, sleep     disturbances, and chronic headaches. Furthermore, sleep disruption of one of the most common     complaints in patients suffering from traumatic brain injuries, with as many as 40 to 65% of     patients with mTBI complaining of insomnia. Sleep problems in these patients are associated     with poorer outcome, while resolution of the sleep disturbance is associated with improvement     in cognitive functioning.      Despite recent evidence of the correlation between sleep quality and recovery from traumatic     brain injury, and the well-established role of sleep in neural plasticity and neurogenesis,     there have been virtually no direct studies of the causal effects of sleep on recovery     following mTBI. However, it is quite likely that sleep plays a critical role in recovery     following brain injury.      A particularly promising non-pharmacologic approach that shows potential in     improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright     light therapy. For the proposed investigation, the investigators hypothesize that bright     light therapy may be helpful in improving the sleep of patients with a recent history of mTBI     and may also have other mood elevating effects, both of which should promote positive     treatment outcome in these individuals. Bright light therapy may increase the likelihood that     they will recover more quickly, benefit more extensively from other forms of therapy, and     build emotional and cognitive resilience.      This study will also have a healthy control (HC)/effect localization arm that will assist in     identifying and mapping the brain systems before and after light exposure so that researchers     may develop further insights into the relationship between concussion, light exposure, sleep,     and brain function. This healthy control arm will also provide brain targets for study in the     analysis of the Main Study Arm.   "
69591|NCT02374905|"     The investigators wish to investigate the feasibility of using a web based drinking app     (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient     clinic in a dental setting.   "
69592|NCT02374892|"     The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation     Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led     transition intervention in combination with usual care, versus usual care alone, on preparing     adolescents with congenital heart disease (CHD) to successfully transition from pediatric to     adult cardiology care. The Canadian Pediatric Society and American Academy of Pediatrics have     recommended that transition interventions begin in early adolescence. Therefore, the     investigators propose to conduct a nurse-led intervention that addresses the educational     needs of 13-14 year olds.   "
69593|NCT02374879|"     This is an open-label, non-randomised pilot study, to evaluate user performance and system     accuracy in blood Glucose monitoring system with glucose adjustment. Twelve male and female     volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 will be     enrolled in this study.   "
69594|NCT02374866|"     The literature data show that long-term monitoring has an effect on weight loss, comorbidity     and on improving the quality of life. However, there are still no studies on monitoring obese     patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011     advocated continuous monitoring needed to prevent weight regain, monitor the consequences of     overweight and treat comorbidities. This requires a long-term support. The frequency of     follow-up consultations is not specified and must be adapted to achieve a weight loss target     and maintain. Having no specific recommendations on the frequency of monitoring, the     investigators chose to experiment closer monitoring than our current monitoring to assess     what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding     behavior, changes in physical abilities, evolution of comorbidities associated with obesity.     The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for     weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with     obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).   "
69595|NCT02374853|"     The purpose of this research is to determine if using the antibiotic vancomycin as a     preventative topical (on the surface of the skin) treatment during open-heart surgery will     reduce the risk of developing a sternal wound infection.   "
69598|NCT02374814|"     The purpose of this study is to compare the effectiveness of a two dose versus a three dose     schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.   "
69599|NCT02374801|"     The objective of the Continued Access study is to gather confirmatory evidence on the safety     of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and     interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac     Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient     population that is reflective of current heart failure treatment practice.   "
69600|NCT02374788|"     The aim of the study is to investigate the effects of two levels of primary care physical     activity interventions on metabolic control and cardiovascular risk factors, compared to     usual care in patients with pre- and type 2 diabetes.      The hypothesis is that both levels of interventions have effect on HbA1c with the more     intense Group intervention having superior effects.   "
69601|NCT02374775|"     The EMERALD trial is a multinational, multicenter study. The patients presented with     AMI/definite evidence of plaque rupture and had underwent coronary CT angiography from 1     month to 2 year prior to the event will be retrospectively searched. Plaques in the     non-culprit vessels will be regarded as internal control to the ruptured plaque in the     culprit vessel.   "
69602|NCT02374762|"     The goal of this study is to find the best techniques to take non-invasive images of the     arteriovenous fistula (AVF) in hemodialysis patients.   "
69603|NCT02374749|"     Giving both the gap existing between the current recommendations to prevent/detect     comorbidities and the clinical practice in patients suffering from spondyloarthritis and also     the specificity of some recommendations to rheumatic diseases, it seems logical to check     these recommendations in a rheumatologic environment.      This study with its two parts should be able to demonstrate:        -  The importance of a systematic evaluation of comorbidities in Spondyloarthritis,        -  The utility of a nurse-led program of self-assessment and self-management of the disease   "
69604|NCT02374736|"     The principal objective of this pilot study is to determine whether the progression of     chronic antibody-mediated rejection (ABMR) could be minimized by the post-transplant     administration of high dose of Intravenous Immunoglobulins (IVIg).      We test the hypothesis that repetitive IVIg administration reduces or stabilize the     progressive loss of transplant function and the evolution to chronic ABMR in stable kidney     transplant patients with HLA-DSA developed post-transplantion (de novo HLA-DSA) and     concomitant humoral graft injury.   "
69605|NCT02374723|"     Constructs made from cross-linked Human Recombinant Collagen type III are being used instead     of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients     serve as controls and are receiving human donor corneas using the same surgical technique.     The twelve patients will be recruited from the local waiting list for patients to be     undergoing corneal grafting. If the patients meet the inclusion criteria and agree to     participate following oral and written consent, they will be randomized to either group. The     patients will be followed for 12 months and documented with OCT, In Vivo Confocal Microscopy,     slit lamp photography a o. The study is planned as a safety study with initial efficacy     documentation.   "
69606|NCT02374710|"     Although extensive research has been carried out on Anterior Cruciate Ligament (ACL) femoral     tunnel placement, very little attention has been given to the tibial tunnel. Researchers have     suggested that the tibial tunnel be placed in the center of the ACL footprint, which they     described as being approximately 43% of the way (anterior-to-posterior) across the proximal     tibia at its widest extent. However, others have suggested that a more anterior placement may     yield improved biomechanical and clinical results. The center of the ACL footprint and the     posterior aspect of the anterior horn of the lateral meniscus does not yield tibial tunnel     placement a consistent percentage of the way across the tibial plateau; therefore, guidelines     should be based on intraoperative fluoroscopic measurements. However, the question remaining     is what percentage of the anterior-to-posterior distance across the tibia is the ideal     location for the tibial tunnel in ACL reconstruction. This study will help answer that     question.      Patients with a diagnosed rupture of the ACL who are scheduled for surgical reconstruction     will be considered for enrollment. Eligible patients will be allocated to one of two groups     based on the location of the tibial tunnel (anterior vs. posterior) during the surgical     procedure. In addition to a baseline (pre-operative) evaluation, participants will return for     follow-up visits at 6, 12, and 24 months post-surgery. Follow up will be completed at 24     months.      The primary objective of this study is to collect subjective and objective measures of     knee-related function in patients with an anterior vs. posterior placed tibial tunnel through     24 months postoperative care.   "
69607|NCT02374697|"     The purpose of this study is to determine whether digitalizing pathological slides and let it     accessible on a server for a second medical opinion (tele-expertise) would reduce the time to     diagnosis.   "
69608|NCT02374684|"     The purpose of this study is to determine the safety and tolerability, and to evaluate the     pharmacokinetic characteristics and food effect of Methosulide after oral administration in     healthy adult subjects.   "
69609|NCT02374671|"     The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro     Insert System for the improvement of near visual acuity in presbyopic patients.   "
69610|NCT02374658|"     The ARTS-REHAB Project Research Study examines how meaningful engagement in a creative     process might impact inpatients in rehabilitation centres. Participants in this random     control trial study will be recruited from a slow-stream rehabilitation patient population.     The study intervention will consist of The Royal Conservatory's Living Through the Arts     program. Data will be collected using structured and semi-structured questionnaires along     with observational logs and focus groups. This study will explore the effects of the program,     comparing the intervention and control group participants' sense of hope and optimism for     returning to their daily lives, as well as their sense of engagement in their physical     recovery.   "
69611|NCT02374645|"     This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib in     patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and progressed     on EGFR Tyrosine kinase inhibitor (TKI) treatment.   "
69627|NCT02374437|"     This is a single-site, randomized, partly double-blind, placebo-controlled study of Aramchol     in sixty six (66) healthy male volunteers.      In each part of the study subjects will be enrolled in the study within 28 days before drug     administration(s).      The study will consist of three parts and the subjects will be assigned to three Parts.   "
69612|NCT02374632|"     After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined     as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem     important for appetite reduction and subsequent weight loss after gastric bypass, however it     is not clear whether different gut hormone responses are responsible for different     postoperative weight loss responses. The purpose of the study is to investigate gut hormone     secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients     with suboptimal weight loss after gastric bypass and compare results to a matched group of     gastric bypass operated patients with high postoperative weight loss but similar age, sex and     preoperative BMI.   "
69613|NCT02374619|"     Iron supplementation is very common in athletes, probably due to its catalytic role on the     oxygen transport and optimal function of oxidative enzymes and proteins during exercise.      Iron is also characterized as a potent pro-oxidant, as it can lead to increased production of     reactive oxygen and nitrogen species (RONS) that are involved in critical biological     processes, such as gene expression, signal transduction and enzyme activity. In exercise, low     levels of RONS are essential for optimal force production, whereas excessive production of     RONS can cause contractile dysfunction, resulting in muscle weakness and fatigue. On the     other hand, RONS are involved in signaling pathways and up-regulation of the expression of     several genes, and therefore, RONS can provoke favorable effects such as training     adaptations.      The purpose of the present study is to investigate the effect of iron supplementation on     redox status, muscle damage and muscle performance after an acute bout of a valid muscle     damaging eccentric exercise model in adults and children.   "
69614|NCT02374606|"     A strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was     developed to precisely and conveniently measure static limb strength in patients with ALS.     The investigator will compare ATLIS data with data from the commonly used ALS outcomes     measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory     measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both     outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic     visits during the study period.   "
69754|NCT02372786|"     The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream     and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single     laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.   "
69615|NCT02374593|"     This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as     visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric     levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the     study for targeted dosing will be compared to controls obtained by retrospective chart     review. The main outcome is to determine if there is a difference in the frequency of     over-treatment and under-treatment during the first 6 months of therapy.   "
69616|NCT02374580|"     For more than a decade, Uganda's Ministry of Health has led a community health worker program     model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are assigned the     task of delivering preventative health services and education to their local communities.     Studies have demonstrated the effectiveness of Uganda's VHTs in improving certain health     outcomes; however it is known that VHTs are not optimally supported, and there has been VHT     attrition in recent years. The Ministry of Health has recognized the inadequate support of     VHTs thus far and is aiming to expand VHTs to all local governments and explore ways of     sustaining VHTs. The objective of this study is to evaluate the extent to which material     support is a deciding factor in the efficiency and durability of Uganda's VHT initiative.     Material support may take the form of monetary stipends, regular payment, transportation     assistance, or nonfinancial materials such as bicycles or mobile phone airtime. This study     will review existing literature and gather novel data through surveys of VHT members and VHT     stakeholders. The quantitative and qualitative survey data will be analyzed for trends that     may point to a conclusion in the context of existing health policy discourse on community     health worker remuneration. The purpose of this study is to strengthen the knowledge base on     whether or not the current absence of material support significantly limits the potential for     Uganda's VHTs to be sustained and expanded. This information can be used by governmental and     non-governmental organizations in their work to strengthen and sustain VHTs throughout the     country.   "
69617|NCT02374567|"     The purpose of this multicenter-study is to investigate safety of psychopharmacological     treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly     people are at higher risk for developing side effects under pharmacological treatment due to     an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore     gerontopsychiatric patients can often not articulate their symptoms clearly, for example due     to pronounced cognitive impairment.      The aim of the study is to gain valid data of possible adverse drug reaction rates, their     potential risk factors and outcome, as well as medical prescription practises.      To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the     five participating study sites.      At Baseline demographic data, previous and present disorders, use of drugs, previous and     present medication, quality of life, cognitive function, physical examination results,     laboratory results and ECG will be assessed.      Afterwards patients are visited weekly and screened for possible adverse drug reactions. All     adverse drug reactions will be coded in the MedDRA-system.      In case of a possible serious adverse drug reaction serum levels of all psychotropic     substances applicated will be assessed. Drug combinations will be analysed using an     established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible     adverse drug reactions are documented continually.      2 weeks after discharge from the ward, patients will be contacted by phone to assess     catamnestic data.   "
69628|NCT02374424|"     Aim of this trial is to assess the efficacy of new anti-CD20 antibody (GA101) in association     with DHAP as induction therapy before high dose chemotherapy BEAM with ASCT in patients with     relapsed/refractory DLBCL.   "
69629|NCT02374411|"     The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy)     surgeons is to determine their knowledge of and attitudes towards the nutritional support     needs of HIPEC patients and what their practice patterns are with this patient population.   "
69630|NCT02374398|"     The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the     postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the     simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The     assumption is that the combination of iv TXA and Aquamantys system will enable an improvement     in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated     by the use of Aquamantys system alone.   "
69618|NCT02374554|"     Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient.     Various devices using different techniques are available to measure RR. One technique,     capnography, uses continuous monitoring of expired gases, via a nasal cannula to assess end     tidal CO2 concentration. This long-established technique is frequently used for patients in     intensive care. Both RR and the shape of the capnogram waveform, which has a wave pattern     marked by alternating inspiratory and expiratory phases, are used to help monitor the     patient. Clinician Over-scored End Tidal C02 (COSC) waveform (whereby an expert identifies     and scores each breath on the waveform and counts the number of breaths per minute) is     considered to be a gold standard for measuring RR.      Being able to record RR, without contact or interference with the patient is appealing     because it requires minimal patient co-operation, enables measurements even during acute     respiratory conditions, and may be more representative of real life physiology. Based on a     principle originally described in the 1980s, a novel instrument that uses a completely     non-contact system based on structured light plethysmography (SLP) has recently been designed     by Cambridge University Hospitals Foundation Trust. The device has been refined with the     development of the Thora-3Di by Pneumacare Ltd, Cambridge. A grid of visible light is     projected onto the thoraco-abdominal wall and two digital video cameras record changes in the     grid pattern due to breathing motion. A waveform is produced by the anterior excursion of the     thoraco-abdominal wall (SLPVol) over time, and a numerical output of RR is provided . The     present study aims to simultaneously measure tidal breathing with the Thora-3Di and a BCI     Capnograph 9004 device to compare the Thora-3Di RR output against that of the gold standard     clinician over-scored end-tidal C02 (COSC) and to assess equivalence of the two devices with     the aim to establishing the validity of SLP for RR measurement.   "
69620|NCT02374528|"     The repairing of various wounds is always a great challenge in burn surgery and plastic     surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to     secure the graft to the wound bed, however, there is some evidence to show that irregularly     contoured recipient sites, poorly healing areas, reduce the success rate of skin-grafting     with traditional bolster dressings, increasing morbidity, pain. Negative pressure wound     therapy has been advocated as a potential solution to some of these issues. To further test     the healing rate and safety of this new method, the investigators propose a prospective     randomized controlled trial to compare this method with traditional bolster dressings     application in skin-grafting.   "
71598|NCT02348593|"     This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter,     4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of     excessive sleepiness in adult subjects with narcolepsy.   "
69621|NCT02374515|"     This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection     rate at colonoscopy. This study involved patients undergoing elective screening or     surveillance colonoscopy.      Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before     undergoing a second colonoscopy by the alternate method. The primary outcome measure was the     detection rate for adenomas between patients who underwent Endocuff first and patients who     underwent regular colonoscopy first.   "
69622|NCT02374502|"     Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine.     This results in back pain and stiffness, and causes difficulty with daily activities.     Physical activity and exercise are key components of the management of ankylosing     spondylitis, however many adults with ankylosing spondylitis do not meet physical activity     recommendations. This study aims to investigate the effects of a twelve week intervention     designed to increase physical activity and exercise in adults with ankylosing spondylitis.   "
69623|NCT02374489|"     Primary objective:      To investigate the objective response rate in patients with ROS1 or ALK over-expressed     locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378     Secondary objectives:The progression-free survival ,The disease control rate ,The overall     survival ,The toxicity profiles , The correlation between clinical outcomes and the potential     predictive biomarker for tumor response   "
69624|NCT02374476|"     This non-randomized study will examine the safety and efficacy of irrigated bipolar     radiofrequency (RF) ablation in the treatment of ventricular tachycardia (VT) in patients for     whom standard VT unipolar RF ablation has been unsuccessful. VT is a serious abnormality of     the heart's electrical system. Ablation is a procedure that cauterizes heart tissue using     catheters (long tubes that can be moved within or along the outside of the heart).     Cauterizing the heart tissue is accomplished by using heat to damage the abnormal heart     tissue that is not working well so that it can stop affecting the rest of the heart. Usually,     heat is delivered using a unipolar catheter, in which energy travels from the catheter tip to     a grounding pad. This research study seeks to find out if a bipolar ablation catheter, in     which the energy travels between two catheter tips on either side of the heart muscle, can be     used to eliminate the arrhythmia when the unipolar ablation is unsuccessful. The hypothesis     is that the increased current density and improved rates of transmural lesion creation seen     with bipolar RF ablation will lead to successful arrhythmia termination with minimal or no     increased risk of complication.   "
69625|NCT02374463|"     Falls are dangerous leading to injuries and even death. The VA has made fall prevention a     priority, but effective programs only reduce falls by 30%. Tai Chi, a standing exercise     program, has been effective at improving balance but may not prevent falls. Most falls occur     during walking when an individual experiences a slip or a trip. Programs that focus on     walking, stepping, and recovery from a slip may be more effective at fall reduction. This     study will compare Tai Chi to a novel multimodal balance intervention (MMBI). MMBI focuses on     standing balance, walking, stepping, strength training, and recovery from a slip. The     Investigators believe that the MMBI program will be more effective than Tai Chi at improving     balance and preventing falls in older Veterans and the Investigators will use the results of     this study to develop a larger study on fall prevention in older Veterans.   "
69626|NCT02374450|"     The purpose of this pre-licensure cohort study is to estimate the incidence of adverse events     of special interest (AESI), other adverse events (AE) leading to hospitalisation or death,     meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of     this study will provide the baseline data for the post-licensure EPI-MALARIA-003 (115056)     study that will evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine.      An interim analysis will be performed when the RTS,S/AS01E vaccine will be implemented in     most of the study sites. This interim analysis will be done with clean data collected on a     sub-group of subjects having 6 months of follow-up following the administration of dose 3 of     DTP/HepB/Hib vaccine (6 12 weeks group), or 6 months after Visit 3 (5-17 months group);     corresponding to Visit 5. The interim analysis will concern primary safety endpoints and the     main impact endpoints (at 6 months post last dose for the purpose of this interim).   "
69631|NCT02374385|"     Background:      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has     affected several thousand people. There is no approved effective way to treat or prevent     Ebola. Researchers are trying to develop a vaccine for it.      Objectives:      To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how     it affects people's immune system.      Eligibility:      - Healthy men and women ages 18-65. They must not have a chronic medical condition that     requires medicine. They must not be a healthcare worker, an animal care worker, or a     childcare worker, and they must not have a household contact that has a compromised immune     system, is pregnant, or is under the age of 5 years.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Participants will be randomly assigned to get the vaccine or the placebo.        -  At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The vaccine          or placebo will be injected into the upper arm muscle.        -  Participants will return to the clinic 11 times over the next 6 months. Participants          will have blood drawn at every study visit. Their mouth will be swabbed and urine tested          at least four times after vaccination.        -  For 14 days after vaccination, participants will write down their temperature, any          symptoms, and any redness at the injection site. They will bring the booklet to each          study visit.      All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK Health     Centre, Halifax, NS.   "
69700|NCT02373488|"     The aim of this study is to investigate the effect of connective tissue manipulation and     abdominal massage on severity of constipation and health related quality of life in patients     with chronic constipation. According to literature, there are studies that investigate the     effects of abdominal massage on bowel movements. But there is no randomized controlled trial,     explore the short and long-term effects of different massage technics on chronic     constipation. Hypothesis of this study is that connective tissue manipulation and abdominal     massage improves symptoms of constipation and health related quality of life in patients     suffering with constipation.   "
69755|NCT02372773|"     This study is being done to learn more about normal thinking and behavior, mild thinking and     behavior problems, Frontotemporal Dementia and other forms of dementia in families in which     one or more relatives have a mutation associated with Frontotemporal Dementia.   "
69632|NCT02374372|"     The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM.     This is a prospective randomized study that will compare the two treatment modalities, HD and     HDF, through economics and pharmaco-economics parameters.      Patients, who had previously been randomized in the CONTRAST study, will remain in their     respective group and monitoring will continue. The next patients will be randomized in the     same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will     receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases,     HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be     avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).      Length and frequency of sessions will be the same in the 2 groups. Blood tests will not     change and will be the same than those used as routine assessments. Metabolic control of     patients will be maintained according to the guidelines. Patients will be monitored for a     minimum of 3 years. A set of demographic and clinical data will be collected from patient     medical records and throughout the study.      Biochemical data as part of the usual blood tests of dialysis patients will be collected each     month as well as will be stored and analyzed information about the annual cardiac     ultrasounds.      All events will be scored (hospitalizations, patterns, duration) and the list and cost of     drugs will be compiled every three months. These data will be useful in the economic analysis     comparing the two treatment modalities.   "
69633|NCT02374359|"     There is few information about the association between supraventricular arrhythmia different     from atrial fibrillation (AF) or atrial Flutter and the risk of stroke. In this study the     investigators hypothesized that the presence of atrial tachycardia would lead to atrial     fibrillation and recurrent stroke in patients hospitalized for cryptogenic stroke.      The investigators study the association of atrial tachycardia (AT), defined as four or more     consecutive premature atrial beats, and AF, recurrent stroke and cardiovascular mortality in     192 consecutive patients hospitalized because of cryptogenic stroke. The follow-up was 12     months for all population   "
69634|NCT02374346|"     To evaluate the association of anaesthesia and surgery with postoperative headache in     elective surgery patients By multiple logistic regression analysis of data collected during a     six-month period from 446 patients undergoing elective surgery, a prospective single centre     cohort study in a university hospital. Participants were interviewed preoperatively and for     five days postoperatively regarding the appearance of headache; while demographics, life     style, type of anaesthesia and surgery, the anaesthetic drugs administered and intraoperative     adverse effects in elective surgery patients are recorded.   "
69635|NCT02374333|"     This is a pilot study to evaluate humanized CD19 redirected autologous T cells (or huCART19     cells) in patients with relapsed or refractory CD19+ leukemia and lymphoma that was     previously treated with cell therapy. This study is targeting pediatric patients aged 1-24     years with CD19+ B cell malignancies with no available curative treatment options (such as     autologous or allogeneic stem cell transplantation) who have a limited prognosis with     currently available therapies and were previously treated with a B cell directed engineered     cell therapy product.   "
69636|NCT02374320|"     The purpose of this study is to investigate whether the use of the study drug (Exparel) is     safe and effective for treating circulation problems and pain in the hand or fingers.   "
69637|NCT02374307|"     The aim of this study is to investigate the effect of a falls-prevention program on quality     of life, fear of falling, falls and physical function in older people receiving home-help     services. The participants in the intervention group will perform conduct the Otago exercise     programme. The participants in the control group will continue with their usual activities.   "
69638|NCT02374294|"     In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the     surgical site) has been shown to decrease infection rate. Several pressure wounds in the     coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy     (TCOT) Given the wound healing properties of TCOT, particularly in infection-prone anatomic     locations such as coccyx, and the microbicidal properties of oxygen, it is expected that the     infection rate in abdominoperineal (AP) resection surgery can be reduced with transdermal     continuous oxygen therapy. The primary objective of this study is to compare the number of     surgical site infections associated with perineal surgery within 28 days between subjects     randomized to receive EPIFLO or Standard of Care   "
69672|NCT02373852|"     The objective of this study is to collect data on the use of the WIRION system in Patients     undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).   "
69834|NCT02371733|"     Decreased exercise capacity, peripheral muscle strength and quality of life and increased     dyspnea and fatigue perception is prevalent in patients with pulmonary arterial hypertension.     It was demonstrated exercise training has beneficial effects in patients with pulmonary     arterial hypertension. However, no study investigated the effects of upper extremity aerobic     exercise training, therefore effects of upper extremity aerobic exercise training on outcomes     in patients with pulmonary arterial hypertension.   "
69639|NCT02374281|"     The management of the pain is a constant care concern in neonatal and maternity units. Many     studies show an interest in the use of sugar solutions to reduce nociception during painful     events in infants. However, these studies are based mainly on behavioral observation of the     newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose     solutions.      Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a     subcortical reactivity notably by action via the brain stem. To explore the intensity of pain     and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability     (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the     autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a     composite pain score (DAN score).   "
69738|NCT02372994|"     This project will pilot and test a new online communication tool, Loop, developed within a     research framework with participatory and user-centred design. This pilot trial focuses on     advanced cancer as an example of complex care. Cancer care involves many healthcare     providers, spanning hospital to home. There is no organized way for them to communicate. Loop     is a practical tool for ongoing collaboration in the patient's actual team of care that     engages patients. The study will answer the questions: does Loop improve communication     efficiency, engage patients and family physicians, and show early benefits in quality and     health care costs?   "
69640|NCT02374268|"     Sarcopenia represents the loss of skeletal muscle and strength that occurs with aging. It is     a major component of frailty and its effect on daily functioning, falls, and fractures has     been well documented. Along with the population aging worldwide, the number of people with     sarcopenia is expected to increase and, thus, contributing to dependency and the anticipated     increase in health and social care costs. The cause of sarcopenia is multifactorial. Recent     evidence suggests that some reversibility exists, highlighting the importance of intervention     modalities. However, the role of nutritional supplementation and exercise programs, either     individually or in combination, is still uncertain, and further randomized controlled trials     (RCTs) have been recommended by the International Sarcopenia Initiative. Therefore, the     investigators plan to conduct a 24-month RCT to compare the effectiveness of 12-week exercise     program alone, combined exercise program and nutrition supplement, and non-exercise control     group on improving muscle mass, strength and power and physical performance in Chinese older     people who have sarcopenia defined using the Asian Working Group Criteria (AWGC). The     investigators hypothesize that compared with the non-exercise control group, there will be     improvement in muscle strength, power and mass, and physical performance in the exercise     alone group, and that there will be an additive effect with the combined exercise and     nutrition supplement group. Chinese older people aged 65 years and over will be recruited for     a brief screening of sarcopenia and cognitive status. Potential subjects will further     undertake detailed body composition and biochemical measurements to check for their     eligibility. Eligible subjects will be randomized to one of the three groups: exercise     program alone, combined exercise program and nutrition supplement, or waitlist control group     with the same exercise program offered after 24-week of study enrollment. Each group will     have 45 subjects. Outcome measurements including muscle strength, power and mass, physical     performance, instrumental activities of daily living and related biochemical measurements     will be made at baseline, 12 and 24 weeks.   "
69641|NCT02374255|"     The goal of this study is to increase and improve Goals of Care discussions for advanced     cancer patients by training medical oncologists to conduct these discussions. The     investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of     treatment in line with preferences, use of aggressive treatment, and oncologist communication     skill.   "
69642|NCT02374242|"     The purpose of this research project is to test the effectiveness of nivolumab versus     nivolumab together with ipilimumab for the treatment of melanoma brain metastases.      Patients are eligible to join this study if they are aged 18 years or above and have been     diagnosed with melanoma with brain metastases.   "
69643|NCT02374229|"     The aim of this prospective randomized study was to evaluate the effectiveness and safety of     the original ablation procedures ganglion plexus pulmonary artery with simultaneous     correction of valvular heart disease, complicated by high pulmonary hypertension.   "
69644|NCT02374216|"     The purpose of this prospective clinical trial is to investigate and identify factors     associated with the failure of dental implants within the population rehabilitated with     dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27,     Malmö).   "
69645|NCT02374203|"     The investigators first aim is to compare the EE and BEE in critically ill patients in     Taiwan. The second aim of this study is to examine protein requirements in different age     groups in critically ill patients, and their relationship to factors causing inadequate     enteral nutrition, duration of mechanical ventilation, newly diagnosed infection and duration     of intensive care unit (ICU) stay.   "
69646|NCT02374190|"     Globally, there is increasing focus on optimization of health system quality. International     austerity, concerns regarding health care safety and effectiveness, and underlying     aspirations to continually improve patient experience and outcomes are among the factors     driving interest in measuring, rewarding, and optimizing quality of care. Care for     cardiovascular diseases is of particular importance as a leading cause of premature death in     the UK and across the world. With this as a backdrop, recent studies reveal the persistence     of significant variations in risk‐adjusted health outcomes across English AMI populations,     suggesting widespread application of ineffective care. In spite of this evidence, little is     known on the extent to which modifiable, care‐related factors explain observed variations in     risk‐adjusted AMI mortality rates. Set in this context, a recent conceptual model -     emphasizing the influence of in‐hospital care on health outcomes - offers a new opportunity     to 1) re‐examine the quality of acute treatment for AMI, and 2) reveal the extent to which     care delivery influences and explains variations in mortality following acute admission. This     study seeks to use data from the Myocardial Ischaemia National Audit Project (MINAP) within a     retrospective, observational paradigm to examine the relationship between primary care,     pre‐hospital patient status, acute clinical management and patient outcomes. Findings are     expected to give a new perspective to quality of integrated AMI care in England.   "
69647|NCT02374177|"     The purpose of this study is to prove the correlation between the post-operative delirium     (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics     would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump     CABG.   "
69648|NCT02374164|"     The purpose of this study is to assess the effect of food on the bioavailability of     febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the     pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.   "
69649|NCT02374151|"     This is a case control prospective study aiming to investigate the accuracy of the     electrohysterography (EHG) compared to the intrauterine pressure catheter ( IUPC) that is     commonly used in delivery room. Women in second phase of labor - indicated for insertion of     IUPC will be asked to participate . Patients that will give their informed consent will be     connected both to IUPC and EHG. Medical history and demographic parameters will be taken. The     graphs will be compared and analyzed for its frequency and intensity. Delivery mode and fetal     well-being will be recorded   "
69835|NCT02371720|"     The purpose of this research study is to learn about ways to help children and adults with     sickle cell disease who are taking the medication, hydroxyurea.   "
69836|NCT02371707|"     This study aims to establish bioequivalence between two tablet formulations of idalopirdine   "
69701|NCT02373475|"     Postoperative pulmonary complications are main cause of overall perioperative morbidity and     mortality in the patients following general anesthesia. A protective ventilation strategy     refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with     positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective     ventilation has been considered the optimal practice in patients suffering from the acute     respiratory distress syndrome (ARDS). However, few human studies have assessed how to     ventilate healthy lungs in patients undergoing general anesthesia, especially in prone     position. Prior studies reported that in the patients undergoing major abdominal surgery in     supine position, intraoperative lung protective ventilator settings had the potential to     protect against pulmonary complications. Therefore, the investigators planned this study to     better specify the effect of intraoperative protective ventilation in surgical patients in     the prone position.   "
69650|NCT02374138|"     Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients     remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when     indicated for persistent or uncontrolled asthma, is a critical component of most asthma     management plans, and other self-management practices such as trigger avoidance are similarly     related to improved asthma outcomes. Adherence to self-management practices is mediated by     multiple factors, including psychosocial stress of parents and their children.      A targeted, culturally appropriate intervention to manage psychosocial stress among the     parents of young, African American, and socioeconomically disadvantaged urban children with     asthma who are receiving guideline-based care may improve asthma self-management, and     therefore asthma outcomes.      Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional,     culturally appropriate and community-based asthma intervention to augment existing     guideline-based best practice. The intervention will target the parents of at-risk, urban,     African American youth, and will employ individualized psychosocial stress management and     peer support.   "
69651|NCT02374125|"     There is not a clear understanding of the origin of symptoms perceived by patients with     impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon     rupture or other pathologies, are present in asymptomatic subjects and subjects with symptoms     and structural integrity can also be found.      Patients diagnosed with subacromial impingement syndrome frequently have myofascial trigger     points in the teres major muscle. Travell and Simons reported that the symptoms caused by     trigger points in this muscle are similar to those experienced by patients diagnosed with     impingement syndrome, but a literature search provides few results regarding relationship     between subacromial impingement syndrome and presence of myofascial trigger points in the     teres major muscle.      This study aims to provide evidence of the results that can be obtained with a specific     approach of teres mayor muscle by two manual techniques, Trigger Point Pressure Release and     Diacutaneous Fibrolysis, in subjects with subacromial impingement syndrome, a condition that     still representing both a diagnostic and therapeutic challenge. Secondary objective is to     compare the outcomes between both techniques to select for each patient the most appropriate     to their needs and characteristics.   "
69652|NCT02374112|"     This study evaluates the effectiveness of medium-term supplementation with creatine to     improve clinical outcomes in well-defined adult CFS population. Half of the participants will     receive creatine while the other half will receive placebo.   "
69653|NCT02374099|"     The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying     Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women     with ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor.   "
69654|NCT02374086|"     Angina in the absence of obstructive coronary artery disease is highly prevalent in women,     and leads to increased risk for major cardiovascular events, including myocardial infarction,     stroke, and heart failure. Annual mortality rates are ten-fold higher than mortality from     breast cancer, and the lifetime cost of health care for women with non-obstructive chest pain     is close to $1 million. Coronary microvascular dysfunction is a major etiological feature of     this disease, and may contribute to disease progression. Despite our general understanding,     effective treatment remains elusive. This pilot study will test whether regular exercise     training can improve/reverse coronary microvascular dysfunction in women with angina but no     obstructive coronary artery disease.   "
69655|NCT02374073|"     Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial     trigger points in teres major muscle can be associated with this syndrome. The investigators     objective is to find out if adding manual therapy specifically for teres major trigger points     can produce better results in these patients.      Method: A randomized controlled pilot study was carried out. Fifty people were randomly     assigned to one of two groups: intervention group or control group. Both groups received a     protocolized physical therapy treatment while the intervention group additionally received     manual therapy for teres major trigger points.   "
69656|NCT02374060|"     To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the     regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal     triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure     will be percent change in central subfield thickness as measured by OCT at 8 weeks.     Participants will continue in the study for 24 weeks in order to evaluate relative effects of     the 3 treatment strategies on the duration of treatment effects, requirement for additional     injections, and adverse effects.   "
69657|NCT02374047|"     This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple     ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054)     or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single     dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second     dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or     placebo will be administered as a single dose in a fasting state, and subjects will return     for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be     administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In     selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess     safety in anticipation of future clinical trials.   "
69658|NCT02374034|"     The primary purpose of this experimental study was to determine the acute effect following     one treatment and the short-term effect after a two-week program of Egoscue corrective     exercises on chronic knee and hip pain.   "
69659|NCT02374021|"     In a randomized controlled clinical trial, investigators will compare the effects on     [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from     two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate     responders (MTX-IRs). Two common RA treatments will be compared: triple therapy     (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF)     inhibitor (etanercept or adalimumab, plus background methotrexate).   "
69885|NCT02371070|"     The investigators study aims to test the correlation between the Hemochron Signature     point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently     approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to     determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in     real-life stroke patients.   "
69660|NCT02374008|"     Purpose:      The purpose of this study is to evaluate the postoperative analgesic effect of a combined     Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the     tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a     mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and     Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and     Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and     reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and     lethargy compared to the current treatment with local infiltration analgesia.      Background:      Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven     procedure. The nerve blocks have the disadvantage that not only do they anesthetize the     sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve     block causes only stunning of sensory nerves to the knee region. The Obturator nerve block     causes both stunning of the sensory nerves to the knee region and the thighs inward leading     muscles, and does not affect the patient's mobilization capacity.      Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a     well-known local anesthetic. Adrenaline have also been used in other studies, in addition to     the local anesthetic agent, and has been shown to prolong the effect of the nerve block.     Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined     with high dose systemic Dexamethasone has not been systematically investigated in knee     replacement surgery, and it is not known whether this method will provide better pain     treatment.      Method      The patient can receive one of two treatments, determined randomly:        -  A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline)          combined with systemic ketoroloc and high dose Dexamethasone and local infiltration          around the knee joint with placebo medicine (normal saline).        -  B. Both blocks with placebo medicine (normal saline) and local infiltration around the          knee joint with activ local anesthetic.      Neither patient, investigator or staff around the patient will have knowledge of which     treatment the patient has received.      The blocks will be placed before the operation and local infiltration around the knee joint     will be given by the surgeon during the operation.   "
69661|NCT02373995|"     Graves' orbitopathy (GO), also known as thyroid eye disease, affects approximately 3 million     people in Europe with an estimated socioeconomic burden of 6.4 billion euros per annum. GO is     a complication of Graves' disease which is an autoimmune disease and the commonest cause of     an overactive thyroid gland. The treatment of GO remains unsatisfactory and the majority of     patients report long-term impairment of quality of life. The effects of gut derived antigens,     from micro-organisms and nutrients, on the autoimmune response will be tested in the animal     model by probiotic and contra-biotic intervention. In the Indigo interventional trial the     investigators will add to the standard anti-thyroid drug treatment (ATD) a specifically     designed probiotics (LAB4, Cultech Ltd., West Glamorgan, UK) to assess whether it is possible     to modify the microbiome in GD patients and improve their immunological status.   "
69662|NCT02373982|"     This is a Multicenter Observational 1-year retrospective cohort study evaluating the     predictive value of the Left Atrial Sphericity on the recurrence rate of atrial fibrillation     after pulmonary vein ablation procedure.      Inclusion of consecutive patients undergoing AF ablation during 2013 in whom a 3D-imaging of     the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when     procedural/follow-up data was prospectively collected.   "
69663|NCT02373969|"     Verify the changes in coagulation system during total knee replacement surgery with     tranexamic acid single bolus infusion.   "
69664|NCT02373956|"     The main objective of this study is to document the effectiveness of a honey-based medical     device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical     device will be judged according to the evolution of the surface of the wound at the end of 12     weeks of treatment.   "
69665|NCT02373943|"     The main objective of this human trial is the demonstration that β-carotene in fortified     maize has good bioavailability as a plant source of vitamin A and that when humans ingest the     biofortified product retinol levels are higher than when they ingest non biofortified white     maize.   "
69666|NCT02373930|"     Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration     of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir     (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1     reverse transcriptase inhibitor (NNRTI), are approved for the treatment of HIV infection.     This study is aimed to evaluate the relative bioavailability and food effect of single doses     of several experimental fixed dose combination (FDC) tablets of Dolutegravir 50 milligrams     (mg) and Rilpivirine 25 mg (DTG/RPV 50 mg/25 mg) relative to co-administration of a single     dose of the reference single entity products (DTG 50 mg and RPV 25 mg) in healthy adult     subjects. This is a 2-part study. Part 1 will be conducted as a randomized, open label,     3-way, crossover design in 24 subjects. Part 1 will evaluate the relative bioavailability of     up to 4 test formulations relative to the reference single entity products administered in     fed state. Part 2 will be conducted as a randomized, open-label, 3-way crossover design in 3     distinct cohorts each with 12 subjects. Part 2 will evaluate the relative bioavailability of     up to 3 most promising FDC formulation selected from Part 1 (DTG/RPV FDC-1, DTG/RPV FDC-2,     DTG/RPV FDC-3) administered in fasted and fed state. Subjects will also receive the reference     treatment from Part 1 co-administered under fasted conditions. This study will consist of a     screening visit, three treatment periods each with a single dose of study drug separated by a     washout of at least 9 days and a follow-up visit. The total duration of participation of a     subject in this study will be approximately 10 weeks.   "
69667|NCT02373917|"     In this study the investigators will collect Blood,sputum and saliva samples for     Characterization of Methylation Patterns in lung Cancer.   "
69668|NCT02373904|"     The purpose of this study is to collect safety and performance data of the Photodynamic Bone     Stabilization System (PBSS) when used for the treatment of painful impending and actual     fractures of the humerus secondary to metastatic cancer.   "
69669|NCT02373891|"     Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally     administered as a salt composed of an acid-base as a compound that was synthesized by and     chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to     the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows     the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and     by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory     activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state     is allowed to recuperate or extended.      It was developed to improve compliance improve pharmaceutically Acebrophylline that intake     twice daily 100mg to Surfolase CR that intake once daily 200mg   "
69670|NCT02373878|"     The purpose of this study was to evaluate the impact of telecoaching conducted by a counselor     trained in motivational interviewing paired with a portion control device for obese patients     receiving care in a certified patient-centered medical home. The investigators will conduct a     randomized, controlled clinical trial evaluating the effectiveness of a telecoaching     intervention with a portion control device.   "
69671|NCT02373865|"     This exploratory double blind randomized active controlled study is designed to assess the     effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage     of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients     inadequately controlled on metformin monotherapy.   "
69673|NCT02373839|"     Preeclampsia is an important disease that develops during pregnancy and it is one of the main     contributors to maternal and fetal complications.      The only known definitive treatment is delivery. Although delivery is always appropriate for     the mother, it might not be the best for a very premature neonate.      In cases of non-severe preeclampsia there no benefit delaying delivery beyond 37 weeks. It is     also well established that before 34 weeks an expectant management confers perinatal benefit     with minimum amount of additional maternal risk. There is then an area of uncertainty between     37 and 37 weeks. This is why in this period it is a clinical need to select high risk     patients of complications that will benefit from labor induction, and differentiate them from     low risk patients that can be manage expectantly until 37 weeks.      Placental growth factor (PlGF) is an angiogenic factor that is lower in pregnant women with     preeclampsia and current evidence shows that it as a predictor of adverse pregnancy outcome     and requirement of delivery.      Circulating levels of PIGF at 34 weeks could help to identify those women that may benefit     from labor induction and those where delivery can be delayed until 37 weeks with low risk for     maternal complications.   "
69674|NCT02373826|"     During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound     (IVUS) is necessary to determine the plaque extension and its composition, lesion length and     luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and     value of a novel method for co-registration of IVUS and coronary angiographic images.   "
69675|NCT02373813|"     The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to     methotrexate monotherapy on maintenance of remission in subjects with Rheumatoid Arthritis     who were on etanercept plus methotrexate therapy.      This is a multicenter, randomized withdrawal, double-blind controlled study in subjects with     Rheumatoid Arthritis on etanercept plus methotrexate therapy who are in very good disease     control for 6 months prior to study entry. The study will consist of a 30-day screening     period, a 24-week open label run-in period, a 48-week double-blind treatment period and a     30-day safety follow-up period.      Approximately 465 subjects will be enrolled and approximately 325 subjects will be randomly     assigned in a 2:2:1 ratio to one of three treatment groups: etanercept 50 mg weekly by     subcutaneous injection plus oral placebo for methotrexate (n = 130), oral methotrexate 10 to     25 mg weekly plus placebo for etanercept (n = 130) and etanercept 50 mg weekly by     subcutaneous injection plus oral methotrexate 10 to 25 mg weekly (n = 65).   "
69676|NCT02373800|"     The primary objective of this study is to determine if a cervical hardness score (determined     by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian     for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode     (ocytocin alone or with an intravaginal device releasing PGE2).   "
69677|NCT02373787|"     A 5-year clinical investigation on creos xenoprotect   "
69678|NCT02373774|"     The purpose of this study is to determine if performing an ultrasound to identify the space     to insert the needle before performing a lumbar puncture will improve success of the     procedure and patient safety.   "
69679|NCT02373761|"     This study seeks to find out if the tibial and patellar components of the Stryker Triathlon     Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.   "
69680|NCT02373748|"     The purpose of this study is to evaluate the movements performed according to the BioGaming     YuGo software, and verify that they are rehabilitation movements.   "
69681|NCT02373735|"     The purpose of this study is to investigate the effect of stroke volume variation (SVV)     guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.   "
69682|NCT02373722|"     This randomized clinical trial studies how well website application (web app) based education     and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a     surgical procedure used to treat skin cancer). Website application and text messaging based     education may help patients stick to wound care instructions before and after surgery, lower     anxiety level, and may help monitor their activity.   "
69683|NCT02373709|"     To elucidate the disease pathway of perinatal depression by identifying genetic variants     which could play a role in predisposing to the condition and/or lead to better understanding     of the pathogenesis of the condition. This is achieved by investigating for associations     between oestrogen receptor genetic variants and perinatal depression.   "
69684|NCT02373696|"     Incidence and risk factors for persistent post surgical pain after Caesarean section are     investigated. Demographic, psychophysical testing and genetic screening factors are performed     in the perioperative period. Phone survey is performed to investigate the incidence of     persistent post surgical pain after Caesarean section.   "
69685|NCT02373683|"     The aim of this prospective pilot study is to determine the effect of heliox delivered via a     proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm     Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.   "
69686|NCT02373670|"     A feasibility study randomizing participants (parents of children age 2-5 years old) to     receive either education or a parent mentor with the aim of improving health behaviors and     improving their body mass index z-score.   "
69699|NCT02373501|"     To evaluate the effects of extra-abdominal repair of the uterine incision compared to     intra-abdominal repair, and to study is there superiority of one technique over the other in     terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post     operative ( until day 4 after operation ) measurements , secondary outcomes, long-term     outcomes and subjective outcomes.      PRIMARY OUTCOMES:      Intra - operative ( during the operation up to 4 hours from anesthesia )        -  nausea and vomiting        -  intraoperative hypotension        -  intraoperative pain      Post operative ( 4 hours from anesthesia and until release from hospital )        -  Blood transfusion        -  Venous thromboembolism        -  Febrile Morbidity        -  Endometritis        -  Wound Infection        -  Death      Subjective measures:        -  complain of pain 1-10 on day 1 post operative        -  time until walking        -  number of Days until having bowel movement        -  overall satisfactory      SECONDARY OUTCOMES:        -  Operative time        -  Estimated blood loss ( ebl ) - hemoglobin levels        -  Hospital stay   "
70063|NCT02368730|"     In this non-interventional multicentre, prospective, observational cohort study, the efficacy     of desmopressin is evaluated in patients with platelet dysfunction due to acetylsalicylic     acid or cox-1-inhibitors within the context of surgical procedures.   "
69687|NCT02373657|"     Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter     Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha     Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We     have found that repeated mass administration of oral azithromycin can greatly reduce the     prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate     infection. The World Health Organization recommends not only antibiotics for control of     trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial     hygiene promotion, and Environmental improvements such as latrines and water points).     Trachoma is more common in villages and households with poor access to water and latrines, so     improving the public health infrastructure is thought to be important for limiting     transmission of trachoma. However, there is very little evidence to support the efficacy of     installing new water points for trachoma. There has been only one previous attempt to study     the role of hand dug well installation for trachoma control, and this study, conducted in     Niger, found that installing wells was not effective. We now propose a project to improve the     public health infrastructure of Goncha Siso Enese woreda by helping with the construction of     water points (e.g., hand-dug wells) and providing hygiene education, in order to determine     whether improving access to water and hygiene information will be effective for control of     trachoma and soil-transmitted helminths.   "
69688|NCT02373644|"     The purpose of the research project is to compare the effectiveness of non-thrust     mobilization and exercise versus thrust manipulation and dry needling in patients with     sacroiliac dysfunction. Physical therapists commonly use both approaches to treat sacroiliac     joint dysfunction, and this study is attempting to determine if one approach is more     effective than the other.   "
69689|NCT02373631|"     The purpose of this research is to compare the effectiveness of conventional physical therapy     (manual physical therapy, exercise, range of motion, and stretching) versus conventional     physical therapy combined with dry needling in patients with knee osteoarthritis (OA).     Physical therapists commonly use conventional physical therapy techniques and dry needling to     treat knee OA, and this study is attempting to find out if the addition of dry needling to     conventional physical therapy has an equal, greater, or lesser effect than conventional     physical therapy alone.   "
69690|NCT02373618|"     The purpose of this research is to compare patient outcomes following treatment of plantar     fasciitis with conventional physical therapy (stretching, strengthening, ultrasound, manual     therapy, and cryotherapy) and conventional physical therapy plus dry needling. Physical     therapists commonly use conventional physical therapy techniques and dry needling to treat     plantar fasciitis, and this study is attempting to find out if the addition of dry needling     to conventional physical therapy is more effective than conventional physical therapy alone.   "
69691|NCT02373605|"     The purpose of this research is to compare two different approaches for treating patients     with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation     and dry needling. Physical therapists commonly use all of these techniques to treat     cervicogenic headaches. This study is attempting to find out if one treatment strategy is     more effective than the other.   "
69692|NCT02373592|"     This study aims to implement daily temperature measurements of feet complemented by SMS and     voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at     high risk of ulceration.      Design: Physician-blinded, randomized, 18-month trial.      Setting: Diabetes outpatient clinics from two public hospitals      Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes     mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in     both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system as     specified by the International Working Group on the Diabetic Foot, (5) have an operating cell     phone or a caregiver with an operating cell phone, and (6) have the ability to provide     informed consent.      Hypothesis: The investigators hypothesize that implementation of an enhanced intervention     that combines daily temperature measurement for the reduction of diabetic foot ulcer with SMS     and voice messaging will improve patient measurement compliance and reduce diabetic foot     ulcers in a middle income country.   "
69693|NCT02373579|"     Study the role of oxidative stress in methotrexate induced hepatic damage, and the possible     protective effect of OMEGA-3 fatty acids against methotrexate hepatotoxicity using clinical     and biochemical parameters.   "
69694|NCT02373566|"     In this study the efficacy of an acellular dermal template (Novomaix), combined with split     thickness skin grafts, for use in patients with full thickness skin defects, is tested.     Results will be compared intra-patient with those obtained after conventional treatment with     split thickness skin grafts. The investigators expect this treatment to provide better     outcome regarding scar quality.   "
69695|NCT02373553|"     MB Children maintains the same postural pattern in preoperative and postoperative     adenotonsillectomy? The age influences the incidence of more exacerbated postural changes?     The proposed early physiotherapy intervention can minimize future functional deficits? Trying     to answer some of these questions, the objective of present study is to investigate the     initial kinematics of the shoulder girdle, cervical and thoracic spine in MB children pre and     post adenotonsillectomy and then evaluate the effects of a physical therapy intervention     program for MB children who persisted with postural changes.   "
69696|NCT02373540|"     The purpose of this study is to obtain real-world clinical outcome data for the Algovita     Spinal Cord Stimulation system when used, on-label, according to the applicable directions     for use.   "
69697|NCT02373527|"     The purpose of this study is to compare the safety and effects of fasting or not fasting     overnight before a cardiac catheterization (heart procedure). The study will compare patients     who have nothing to eat after midnight before the procedure to those who are allowed to eat     or drink before the procedure.   "
69698|NCT02373514|"     Patients presented with dysmenorrhea composed the study population. One gram paracetamol and     50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing     dysmenorrhea in emergency department.   "
69736|NCT02373020|"     Despite the characterization of many aetiologic genetic changes. The specific causative     factors in the development of sporadic colorectal cancer remain unclear. This study was     performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in     developing colorectal carcinoma.   "
69703|NCT02373449|"     Neuropathic or nerve injury related pain (NP), an extremely unpleasant condition that is     difficult to treat, often has a severe, persistent, and unremitting course. Conventional     treatments are often ineffective in relieving NP. Recently, the investigators have developed     a cost-efficient regimen involving use of low dose infusions of ketamine for treating     neuropathic pain in patients in whom oral medications have failed. We have observed excellent     benefits in many of these patients. However, this treatment requires titration and monitoring     during the infusion and currently it is not possible to predict which patients will benefit     from this intervention. The investigators have shown that functional magnetic resonance     imaging (fMRI) of the brain can be used as a tool to predict relief of pain and to assess the     effect of treatment in some chronic pain conditions. This innovative project involves     development of an fMRI-guided treatment with intravenous ketamine in patients with NP. This     study aims to analyze patterns of changes in fMRI of the brain, before and after infusion of     ketamine and to correlate the changes with pain intensity. The information from this study     will help to deliver this therapy earlier to those patients who are most likely to benefit     from ketamine.   "
69704|NCT02373436|"     The hemiparesis is one of the most important sequelae of stroke, and generally have greater     impairment in the upper limb (UL) contralateral to the brain injury. To obtain greater amount     of use and most affected UL movement quality, studies have described as a rehabilitation     technique constraint Induced Therapy (CIT). The objectives of this study will evaluate the     effect of CIT in severe hemiparetics patients in the quantity and quality of movement UL and     grip strength, and the relation between the scapular kinematics and trunk with the quality of     movement measured clinically. Randomized crossover study with systematic reviews in AB mode,     where A is the baseline to the evaluation of the period of 2 weeks without any intervention     and B, the two-week period with intervention. One group will start with the intervention     period (BA) and the other group with the period without intervention (AB). The intervention     will be for 3 hours / day, 5x / week for two weeks and use of wrist and fingers restriction     UL unaffected. To evaluate the quality and quantity of UL use in real environment will be     used to Motor Activity Log (MAL), to quantify the motor skill the Wolf Motor Function Test     (WMFT), the 3D movement of the scapula and trunk during arm elevation and functional     activities of the UL will be measured by the electromagnetic tracking system and grip     strength by hand dynamometer.   "
69705|NCT02373423|"     A clustered-randomized controlled trial in which 45 food companies are the unit of     randomization. The intervention companies will receive an advocacy program which comprises of     commonly used advocacy actions, incorporating a theory of change model. The control companies     will have no specific intervention targeted at them. The aim of this study is to quantify the     effects of advocacy delivered by a local non-government organization on the salt content of     food products produced or marketed by companies in Australia.   "
69706|NCT02373410|"     The purpose of this study is to analyze the accuracy of needle insertion and the discomfort     during different ergonomic conditions faced by anesthesiologists during spinal anesthesia. In     particular,the investigators intend to compare the angles between the patients' back and the     inserted spinal needle in the coronal plane at different operating table heights.   "
69707|NCT02373397|"     The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120) in     improving wound healing and nerve regeneration in the anterior cornea, in a patient     population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal     erosions.   "
69708|NCT02373384|"     The aim of the study is to evaluate the predictors of success of oral dissolution therapy in     radiolucent renal stones in a large series of patients from a tertiary referral center in     order to define the optimum case scenarios where oral dissolution therapy could be     implemented.   "
69709|NCT02373371|"     The main objective of this study is to compare efficacy and safety of Metvix® natural     daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in     subjects with mild actinic keratoses (intra-individual comparison)   "
69737|NCT02373007|"     The purpose of this study is to show that the modified technique Scopinaro surgery allows a     better control or reduction of complications often found in nutritional pancreatic and     biliary derivations, starting from the assumption of a modified technique is as effective as     Scopinaro classical technique for reducing overweight and control of comorbidities in obese     patients with grade II and III.   "
70064|NCT02368717|"     The purpose of this study is to investigate the efficacy and safety of 4-week double-blind     treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to     moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label     extension phase with PENTASA enema and/or PENTASA tablets.   "
69710|NCT02373358|"     Neuroscience evidence indicates that trauma is stored in the body, that trauma impairs the     language centers found in the brain, and that emotion centers in the brain tend to override     cognitive centers in the brain following trauma. Most evidence-based models to date to treat     trauma using cognitive therapy, which does not fully resolve symptoms, particularly in the     case of complex trauma. This evidence has led to researchers to call for alternative,     body-oriented treatments that target trauma from the lowest levels of regulation up to higher     levels of regulation in the brain. Yoga has been proposed as one such intervention. Recent     research has investigated the benefits of yoga to treatment adult females who have     experienced PTSD, but only anecdotal, descriptive, and qualitative data is available for     studies of yoga with adolescents. This mixed methods study seeks to generate quantitative     data demonstrating whether or not the 6-week group yoga intervention leads to decreases in     general mental health and trauma-specific symptoms and qualitative data regarding the     components of the intervention the participants found both helpful and unhelpful.   "
69740|NCT02372968|"     The aim of this pilot study is to develop at Nestlé Research Center a database of metabolic     profiles, body composition, food habits and physical activities on a large cohort of human     volunteers. Analysis of collected data will serve to measure the variability of the data and     to assess the potential of combining metabonomics with imaging techniques (iDXA) to monitor     the metabolic and physiologic effects of foods.   "
69958|NCT02370121|"     Gymnema sylvestre has demonstrated promising effects in the treatment of obesity,     dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings     show that Gymnema sylvestre has an excellent potential for the prevention and treatment of     metabolic syndrome.   "
69711|NCT02373345|"     The purpose of the present study is to determine the association between factors known to be     associated with the development of chronic low back pain (psychological and biological) and     the evolution of functional disability in individuals with a history of low back pain. To do     so, 100 individuals with a history of nonspecific low back pain will be followed over a     period of 18 months. During this time frame, participants will be evaluated three times in     the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance     thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these     participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for     functional disability and pain intensity levels of their low back pain as well as for     psychological symptoms usually associated with the development of chronic low back pain. It     is hypothesized that high psychological symptoms measured initially will be associated with     high functional disability throughout the study .   "
69712|NCT02373332|"     This study investigates the potential protective effects of altering fatty acid in the     platelet as a method for prevention of platelet activation and thrombosis in type 2 diabetes     mellitus. Fatty acids (omega-3 and omega-6) and their oxidized lipids will be evaluated for     protection from agonist-mediated platelet activation in platelets from type 2 diabetics and     healthy controls.   "
69713|NCT02373319|"     The aims of this study are (1) to validate a self-screening method for cardiovascular (CV)     risk that does not require the supervision of a health professional (including     self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and     self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From     these data, the investigators will generate personalized recommendations based on the best     available evidence. The investigators will also analyze whether this innovative approach     improves adherence to preventive recommendations for cardiovascular and other chronic     diseases.   "
69714|NCT02373306|"     Implantable cardioverter-defibrillator (ICD) is a widely used and effective therapy which     reduces the risk of cardiac death in many cardiac diseases, both implanted for secondary and     primary prevention. It is known that recurrent arrhythmias and ICD discharges have adverse     prognostic significance. Parameters that would identify patients who are at increased risk of     arrhythmias and appropriate ICD interventions would be of clinical value. The aim of the     study is to evaluate the usefulness of non-invasive programmed stimulation (NIPS) in     determining the likelihood of life-threatening arrhythmic events in patients with ICD.   "
69715|NCT02373293|"     This is an epidemiological, observational, prospective, multicentric study in 400 adult     patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value     of the antithrombin III in the development of moderate or severe acute pancreatitis.   "
69716|NCT02373280|"     To compare the eradication success rate between 10-days sequential therapy and 7-days     tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.   "
69717|NCT02373267|"     Screening of TMA patients for ADAMTS13 activity and the description of systemic organ damage     and/or organ failure in different entities of thrombotic microangiopathies (TMA)   "
69718|NCT02373254|"     This study is being conducted to evaluate whether NSAIDS are more or less effective in bone     healing than opioids in acute fracture pain. Participants will be randomized to one of three     groups for first line treatment of pain related to the fracture.   "
69719|NCT02373241|"     Untreated hypertension and renal injury are risk factors for increased morbidity and     mortality in sickle cell disease, yet early markers of progressive disease have not been     identified and therapies to prevent the development of adverse cardiovascular outcomes have     not been defined. Circadian blood pressure, as defined by 24 hour blood pressure monitoring,     is more accurate than clinic blood pressure in defining secondary hypertension and abnormal     nocturnal blood pressured dipping and nocturnal hypertension have been linked to progressive     renal disease in other diseases.      Methodology/Aims: A randomized feasibility trial of losartan will be conducted among     adolescent HbSS and SB0 thalassemia patients (11-19 years) with abnormal nocturnal blood     pressure dipping. During this six month feasibility trial, two dosing strategies of losartan     (titrated to keep clinic BP <95th percentile vs. <75th percentile) will be analyzed for     safety and effect on restoring normal circadian blood pressure.      A prospective cohort study among HbSS and SB0 thalassemia patients (6-19 years) will also be     conducted to evaluate the incidence of hypertension and role of monitoring potential     biomarkers of kidney injury and hypertension. Cohort participants will undergo annual     evaluations of hypertension(24 hour blood pressure monitoring for participants ≥ 11yrs,     clinic BP in all participants) and markers of kidney injury/hypertension.      Expected Results: At the completion of the feasibility trial, vital background information     will be obtained to design a definitive multicenter trial of hypertension in sickle cell     disease. At the completion of the cohort study, the incidence of pediatric hypertension will     be identified and the role for monitoring blood and urine biomarkers will be better     understood.      As therapy for patients with renal failure is dismal, it is imperative that SCD patients at     risk are identified early and that therapeutic trials are conducted that prevent progression.   "
69720|NCT02373228|"     Hearing impaired persons suffer from inferior music perception with and without hearing aids.     Hearing aids, however, are primarily designed to improve speech intelligibility not music     enjoyment. This study investigates the potential benefit of signal processing strategies that     are optimized for music. The purpose of this study is to improve music compression for     hearing impaired people.   "
69721|NCT02373215|"     This is a single-center clinical research study with the purpose to evaluate the safety,     tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in     end-stage renal disease (ESRD) patients receiving hemodialysis (HD) therapy and reporting     pruritus.   "
69722|NCT02373202|"     Primary Objective:      To document the long-term safety of sarilumab added to non-methotrexate (non-MTX)     disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.      Secondary Objective:      To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.   "
69739|NCT02372981|"     Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise     the drawbacks of the golden standard of haemorrhoidal treatment, conventional     haemorrhoidectomy techniques. Ligation techniques, such as Doppler-guided haemorrhoidal     artery ligation (DG-HAL), were introduced to reduce the arterial inflow of the AVP and thus     prevent the haemorrhoidal zone from being part of the continence system. Apart from     inappropriate application of this surgical alternative for higher grade haemorrhoids, high     recurrence rates of up to 38% after DG-HAL are due to technical failure of the ligation     technique itself. This is a prospective randomised controlled trial to evaluate the efficacy     of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with     symptomatic grade III haemorrhoids.   "
69751|NCT02372825|"     Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a     formidable challenge for the reconstructive surgeon. These defects can be treated with the     vascularized iliac crest transfer. The purpose of this study is to assess the reliability and     the long-term outcomes of free iliac crest flap transfer for these indications.   "
69723|NCT02373189|"     Nearly 50% of U.S. veterans report they experience pain on a regular basis. This chronic pain     often co-occurs with other disorders including post-traumatic stress disorder (PTSD),     depression, anxiety and insomnia. A common approach to treating chronic pain is opioid     analgesics, which are not always effective, and increasingly associated with abuse and     misuse. Thus, there is an urgent need to develop readily available, safe, and practical     complementary nonpharmacological approaches to manage chronic pain in U.S. veterans. Chronic     pain is a multidimensional phenomenon, inter-related with many factors, including negative     mood and poor sleep. The central circadian clock, in the suprachiasmatic nucleus in the     hypothalamus, is well recognized to regulate both mood and sleep, and even small delays     (shifts later) in circadian/sleep timing are associated with depression and disrupted sleep.     These results suggests that later circadian/sleep timing may be a modifiable risk factor for     pain. Thus, a self-administered morning bright light treatment at home may be a potentially     efficacious adjunctive strategy for managing chronic pain. This R34 grant will develop a     morning bright light treatment to help manage chronic pain and improve PTSD symptoms,     depression, anxiety and sleep in U.S. veterans. Patients will have 7 baseline days at home,     followed by a baseline pain sensitivity assessment and home circadian phase assessment (dim     light melatonin onset). Following an instructional home visit, patients will then     self-administer morning bright light treatment for 6 days, followed by reassessments of pain     sensitivity and circadian phase. Assessments will be repeated after another 7 days of morning     bright light treatment. Pain, mood and sleep (wrist actigraphy) will be assessed daily     throughout baseline and treatment. Pain, mood and sleep will also be rated by veterans daily     during a 1 month follow up after cessation of light treatment. This study will determine the     feasibility, acceptability and efficacy of bright light treatment in a sample of U.S.     veterans experiencing chronic low back pain.   "
69724|NCT02373176|"     [14C]PRC-4016 (Icosabutate) - A Phase I, Open-Label Study of the Absorption, Metabolism and     Excretion Following Oral Dosing to Healthy Male Subjects.      Objective: To evaluate the pharmacokinetics of total radioactivity in blood and plasma and     PRB-01022 (icosabutate) (unchanged drug) in plasma following a single oral administration of     [14C]PRC-4016 to healthy male subjects.      To obtain a mass balance of oral [14C]PRC-4016 by quantifying the urinary and faecal     excretion of radioactivity.      To examine the profile of metabolites in plasma, urine and faeces. To further assess the     safety and tolerability of a single oral dose of [14C]PRC 4016 in healthy male subjects.   "
69725|NCT02373163|"     This trial is designed to:        1. Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel          blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among          hypertensive subjects who live at sea level, at medium altitude above sea level and at          high altitude above sea level.        2. To test whether diferentes exist in the response to therapy among subjects who live at          different altitude above sea level        3. To assess the hemodynamic characteristics of hypertension in populations that live at          sea level, at medium altitude above sea level, and at high altitude above sea level.   "
69726|NCT02373150|"     This study will assess the pharmacokinetics of single and repeated doses of imeglimin in     healthy Japanese subjects, and the safety and tolerability of single and repeated doses of     imeglimin in healthy Japanese subjects.   "
69727|NCT02373137|"     The purpose of this study is to compare visual acuity outcomes of two types of endothelial     keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2)     Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be     randomized to have DSAEK and the other half will have DMEK.   "
69728|NCT02373124|"     This study evaluates the feasibility of a treatment paradigm that involves naturalistic     cocaine use opportunities in the context of psychotherapy aimed at utilizing these     opportunities therapeutically.   "
69729|NCT02373111|"     Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the     intrinsic aging process, and accounts for the majority of age-associated changes in skin     appearance. Reactive oxygen species (ROS) play a key role in UV-induced skin damage and     diminish skin matrix protein levels, leading skin aging. Strategies utilizing endogenous skin     antioxidants as well as plant-derived or synthetic compounds have been examined.      Astaxanthin mainly from marine algae and crustaceans is a kind of carotenoids which were     well-known photo-protective agents with strong antioxidant activity. Several studies have     revealed that supplementation of astaxanthin effectively protect skin against UV damage     through free radicals.      In addition, matrix metalloproteinase-1 induced by UV irradiation is an important step toward     skin aging. Recently, many studies pointed out that phytoestrogens exhibit agonistic and     antagonistic estrogen activities, suppressing activity of MMP-1 in skin. Isoflavone is a kind     of phytoestrogen from soybean and mainly act on skin and bones, inhibiting MMP-1 effectively.      The present study is designed to take isoflavone combined with astaxanthin to maximize their     anti-aging ability and objectively measure the effects of the mixture on facial wrinkles,     hydration, and elasticity.   "
69730|NCT02373098|"     The main purpose of this study is to measure the serum levels of cytokines and chemokines     that are known to increase during multiple sclerosis relapses.      Cytokines are a broad and loose category of small proteins that are important in cell     signaling.      The second purpose of the study is to test the cytokine/chemokine changes measured in the 3rd     and 6th months on the efficacy parameters.   "
69731|NCT02373085|"     Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients     (KTR) is controversial. The investigators performed a comparative, parallel-group,     randomized, open-label study to assess, in a real clinical setting, the feasibility of and     benefit derived from systematic search and antimicrobial treatment of all episodes of AB.   "
69732|NCT02373072|"     This is a study with two sequential cohorts, each with three treatment periods. Single doses     of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose     projected to be under the current limits for drug concentration. Each cohort will aim to     achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary     endpoint is MDS-UPDRS part III.   "
69733|NCT02373059|"     A research study to enhance clinical discussion between patients and pharmacists using a     shared decision making tool for type 2 diabetes or usual care.   "
69734|NCT02373046|"     This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover     study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of     400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in     healthy subjects under fasted conditions.   "
69735|NCT02373033|"     This study evaluates the effects of folate-rich foods regarding improvement of folate status     compared with folic acid supplement. A randomized, parallel intervention trial with two     active groups (folate-rich foods or folic acid supplement) and one control group (apple juice     - 0 µg/d folate) was executed over 12 weeks.   "
71607|NCT02348476|"     This study is a retrospective chart review to assess the tolerability and efficacy of     treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.   "
69741|NCT02372955|"     Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in     patients with type 2 diabetes mellitus. The exact mechanism(s) by which dapagliflozin lowers     clinic SBP is unknown. The primary objective of the study is to determine the effect of     dapagliflozin , 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index     (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Urinary sodium excretion, and     Intravascular volume status will be recorded. The study will involve 21 subjects for a     duration of 16 weeks.   "
69742|NCT02372942|"     Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction     of the 30% of preterm deliveries versus the use of progesterone, in specific selected     patients, with consequent improvement in neonatal outcome.      Secondary endpoint will be compare antibacterial and anti-inflammatory activity of     lactoferrin by evaluation of systemic biochemical and urinary markers.   "
69743|NCT02372929|"     The primary objective of this study is to document all cases of EUS in patients with     esophageal cancer and determine if the inability to advance the gastroscope beyond the tumor     correlates with locally advanced disease stage at Endoscopic Ultrasound.   "
69744|NCT02372916|"     Given the aging population who will be affected by wet AMD and lack of effective GA     treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in     AMD patients with GA, particularly the possible risk of GA development and enlargement. This     potential adverse effect has significant implication in the discussions with patients     regarding the risks and benefits of AMD treatment and injection frequency. While monthly     injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the     risk of GA enlargement may offset this benefit in visual acuity.      Previous studies assessed the association between intravitreal ranibizumab injections and de     novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012.,     Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the     best of the investigators knowledge, there has been no prospective study assessing the     association between intravitreal ranibizumab injections and rate of GA progression in     patients with pre-existing GA. There is also no prospective study comparing the morphological     features of GA between patients who are receiving intravitreal injections and those who are     not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving     and not receiving treatment.   "
69745|NCT02372903|"     One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully     understood. The detection of mast cells in the endometriosis lesions supports the hypothesis     that mast cell degranulation may contribute to development of pain and hyperalgesia.      N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and     pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy     of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with     endometriosis.   "
69746|NCT02372890|"     In head and neck squamous cell carcinoma (HNSCC), the presence of lymph node metastases in     addition to free resection margins following surgical resection of the primary tumor is an     important prognostic factor, and may impact planning of surgery as well as of radiotherapy.     Until now, imaging modalities including PET/CT and MRI did not allow to exclude especially     small lymph node metastases.      Compared to standard whole-body PET/CT acquisition techniques, high-resolution (HR) head and     neck PET/CT acquisitions promise improved detection of lymph node metastases in head and neck     squamous cell carcinoma (HNSCC). This prospective study aims to determine the sensitivity and     specificity of lymph node staging with HR FDG-PET/CT in HNSCC by correlating PET/CT with     histopathology after neck dissection. HR PET/CT may have a relevant impact on the therapeutic     concept, and the planning and dose prescription of radiotherapy.   "
69747|NCT02372877|"     The purpose of this study is to evaluate the performance of the AMICUS Red Blood Cell     Exchange (RBCx) System (Exchange and Depletion/Exchange procedures) in patients with sickle     cell disease.   "
69783|NCT02372409|"     By employing a combination of advanced MRI techniques and correlative serum biomarkers of     blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of     its kind clinical algorithm in pediatrics whereby the investigators can measure and identify     the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in     incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the     greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor     progression from long-term MLA treatment effects. Preliminary data in adult imaging studies     have shown that the BBB disruption lasts for several weeks following treatment before     returning to a low baseline. This pilot therapeutic study will provide preliminary validation     in pediatric patients.   "
69748|NCT02372864|"     Short Rationale: Risk-reducing salpingo-oophorectomy (RRSO) is a mainstay in preventing     ovarian cancer in BRCA1/2 mutation carriers, as ovarian cancer screening is ineffective in     detecting ovarian cancer in an early and curable stage. Women who underwent RRSO experienced     bothersome menopausal symptoms and worsening of sexual functioning related to acute surgical     menopause. Hormone replacement therapy (HRT) will mitigate some of the RRSO induced     menopausal complaints, however it does not reduce the complaints to a premenopausal level and     the sexual symptoms are not alleviated. Mindfulness interventions were found to improve     sexual functioning and alleviate menopausal symptoms in various populations. It has not been     investigated whether mindfulness-based stress reduction (MBSR) is effective in mitigating the     RRSO-induced menopausal complaints in BRCA1/2 mutation carriers and if this effect is     sustained over a longer period of time.      Objective: To examine the effect of MBSR training on the menopause-specific quality of life     in BRCA1/2 mutation carriers who experience RRSO-induced menopausal complaints.      Study population: Female BRCA1/2 mutation carriers who were younger than 52 years at the time     of RRSO reporting two or more moderate to severe menopause related complaints after     undergoing RRSO.      Study design: Prospective randomized controlled trial with a follow-up time of twelve months     conducted at the University Medical Center Groningen (UMCG)      Intervention: Eight-week MBSR training consisting of a weekly class of two and half hours and     a full retreat day. Furthermore participants are asked to practice mindfulness exercises at     home for 45 minutes, six days a week.      Main study parameters/endpoints: Menopause specific quality of life score measured by the     Menopause-specific quality of life questionnaire (MENQOL). Nature and extent of the burden     and risks associated with participation, benefit and group relatedness: There are no risks     associated with taking part in a MBSR training or filling out the questionnaires that will be     used in this study. The content of the questionnaires concerns intimate matters and could be     considered burdensome. A possible benefit for the participants of the MBSR training is that     participants will be more able to cope with their complaints after RRSO. The group     relatedness is reflected in the fact that RRSO is specifically performed in women with a     hereditary risk of ovarian cancer such as BRCA1/2 mutation carriers.   "
69749|NCT02372851|"     The purpose of this study is to determine whether the use of a point-of-use water filtration     technology can reduce the Arsenic content in drinking water and reduce the Arsenic body     burden.   "
69750|NCT02372838|"     This study assesses the long-term functional outcomes of upper extremity long bone defects     treated with the free fibula bone transfer.   "
69756|NCT02372760|"     Bronchoscopy is a commonly performed procedure for inpatients to visualize the airways when     indicated. It is routinely done for both diagnostic (to lavage and biopsy the respiratory     tract) and therapeutic purposes (to relief an obstruction or remove foreign bodies). Given     the possible side effects of cough of varying severity this procedure can be uncomfortable to     patients, some would even shy away from having a bronchoscopy even when it's medically     indicated.      Recently a spray catheter was designed to deliver more uniform anesthesia to the airways as     compared to the conventional way of injecting the anesthesia into the bronchoscopy working     channel. The investigators aim to conduct this study with the hope of improving patient care,     providing comfortable procedures, helping more patients opt in for bronchoscopy when     indicated.   "
69757|NCT02372747|"     To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis     after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).   "
69758|NCT02372734|"     The research study will investigate the longitudinal cognitive outcomes in subjects admitted     as children diagnosed with sepsis who may have had acute kidney injury. Each subject will be     contacted 2-15 years after their incident admission in order to solicit responses to a     functional and cognitive quality of life survey. Children admitted during the same time frame     that did not have kidney injury will also be surveyed.   "
69759|NCT02372721|"     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly     recognized as a significant factor associated with long-term mortality among different     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in     the development of hypertension and cardiovascular disease. The investigators overall     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,     long-term consequences with regard to kidney function, endothelial function, blood pressure     control, and overall health.   "
69760|NCT02372708|"     To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma     by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and     carry out monitoring on related immunological parameters of the patients.      72 patients with stage III (b or c) or stage IV skin (which could not be excised by     operations) malignant melanoma were treated by combining simple semiantigen DNP in situ     immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg     regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory     cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was     monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was     observed, and results of clinical follow-ups were also examined.   "
69761|NCT02372695|"     To provide evidence based prospectives of the potential benefit effects of paricalcitol, an     analog of vitamin D, over the prevention / retardation of the progression of neoangiogenesis     (vessels), atherosclerosis and vascular calcification.   "
69784|NCT02372396|"     The goal of this project is to refine an existing compassion meditation protocol for     individuals with PTSD, to examine the safety and feasibility of this approach and to collect     data to make initial estimates of efficacy.   "
69762|NCT02372682|"     Reliable methods of evaluating liver fibrosis using noninvasive techniques in the pediatric     population are limited and inconclusive. Liver biopsy remains the gold standard; however, it     requires sedation in pediatric patients, has a risk of hemorrhage, and provides unreliable     results secondary to sampling error. Sonoelastography is a new method of evaluating liver     disease that eliminates these pitfalls. There are 3 types of quantitative sonoelastography     currently in use.      Transient elastography is a non-imaging based technique used in adults to measure liver     fibrosis in which a mechanical vibrator creates a low-frequency wave causing shear stress in     the liver at a fixed depth. This technique does not work in small livers and, therefore, is     not appropriate for pediatric patients.      Acoustic Radiation Force Impulse Imaging (ARFI) and Shear Wave Imaging (SWE) use real-time     ultrasonography and administer focused high-intensity, short-duration pulses to produce shear     waves in the liver tissue. ARFI calculates the degree of tissue displacement and creates an     elastogram or measurement of the stiffness of the sampled liver tissue without corresponding     images. It is limited since only a small sample or region of interest (ROI) can be obtained,     and it is unable to provide a corresponding elasticity map of the tissue.      SWE is the newest elastography technique. It measures tiny displacements of tissue in a     larger ROI with corresponding ultrasound images which provides a side by side image of the     liver and color-coded elasticity map of the sampled tissue. Advantages include a larger ROI     and simultaneous viewing of the selected region of interest which provides better anatomic     detail with a corresponding color map of the tissue elasticity which may result in more     accurate scoring of the stage of fibrosis.      There are a few studies of ARFI in the pediatric population. Studies using SWE for evaluation     of liver fibrosis are also few, and, all but one in adults. However, these studies have shown     it to be an accurate method for liver fibrosis staging. Use of SWE in assessing liver     fibrosis in pediatric patients may represent an accurate noninvasive alternative to liver     biopsy in evaluating liver fibrosis as well as avoid the use of sedation.   "
69763|NCT02372669|"     The objective of this study is to evaluate whether the additional use of a nerve tube in     primary microsurgical repair of traumatic sensory nerve lesions of the hand has an effect on     convalescence and functional results.   "
69764|NCT02372656|"     This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1%     metformin in chronic periodontitis subjects.   "
69765|NCT02372643|"     Monocentric pilot interventional study. The aim of the study is to assess clitoral doppler     ultrasonographic parameters in a population of sexually healthy volunteer women in order to     obtain reference values. Psychobiological correlates of female sexual function will also be     studied through hormonal testing and psychological evaluation.   "
69766|NCT02372630|"     This is a single center, prospective randomized double blind, parallel and placebo controlled     study to evaluate oxidative stress and inflammation before and after treatment with     linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.   "
69767|NCT02372617|"     Prospective study enrolling patients with cerebral palsy and with subluxation of the hips >     40% and acetabular dysplasia. The patients will be stratified according the degree of     subluxation and age. The treatment protocol is composed by femur variation osteotomy and     periacetabular osteotomy. Patients will be divided in two groups according the type of bone     graft used at periacetabular osteotomy (autologous or ceramic).   "
69805|NCT02372123|"     The aim of this study is to investigate the effect of connective tissue manipulation on pain     threshold in women with primary dysmenorrhoea. According to literature, there are studies     that measure the pain threshold. But there is no randomized controlled trial which explore     the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea.     Hypothesis of this study is that connective tissue manipulation increases pain threshold and     decreases severity of pain in women suffer with primary dysmenorrhoea.   "
69768|NCT02372604|"     Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily     urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of     the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in     particular sleep, and generates numerous consultations and hospitalizations, with an average     annual cost per patient close to 2000 euros in Europe. The treatment is based on the     validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose     effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory     to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still     off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as     immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE     biological: the omaluzimab. Several open studies have also suggested superior efficacy and     good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including     levocetirizine.      The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending     to replace the use of anti-H1 first generation or substitution to another 2nd generation     anti-H1 recommended by the French Society of Dermatology.      This study, under the aegis of the Urticaria Group of the French Society of Dermatology,     intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the     treatment of CSU resistant to anti-H1 licensed dosage.   "
69769|NCT02372591|"     Pain is very common in persons with a history of addiction, but few studies have examined the     best treatment of pain in this population. This is a study to determine the pain relief     provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained     on stable doses of methadone or buprenorphine who have chronic musculoskeletal pain.     Experimental sessions will require overnight stays on a residential research unit. In these     sessions, persons will be exposed to standard experimental pain techniques at baseline and     then rate the relief (if any) provided by the study medication when exposed to the same     techniques. Persons will be asked to participate in 3 sessions, each separated by at least 7     days.   "
69770|NCT02372578|"     The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in     subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and     tolerability of ASP3662 relative to placebo.      The analgesic effect is evaluated by measuring percent responders, change in daily worst pain     score, change in average daily pain score, Patient Global Impression of Change (PGIC) and     Clinical Global Impression of Change (CGIC).   "
69771|NCT02372565|"     The purpose of this study is to evaluate the feasibility of a social media and     text-message-delivered, Social Cognitive Theory-based, culturally relevant intervention     designed to promote physical activity among African American women. An 8-week, 2-arm     randomized trial will be implemented. Arm 1 will receive a culturally-relevant,     technology-based physical activity intervention delivered via Facebook and text messages. Arm     2 (Comparison Group) will receive a standard print-based physical activity promotion     materials consisting of high quality physical activity promotion brochures produced by the     American Heart Association.   "
69772|NCT02372552|"     This is a single centre, prospective, non-randomised pivotal clinical investigation to be     undertaken at St Mark's Hospital, Harrow, UK.   "
69785|NCT02372383|"     The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and     pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of     nontuberculous mycobacterial (NTM) lung disease.   "
69786|NCT02372370|"     The study investigates the potential of a range of different physical pretreatments to     enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to     photodynamic therapy (PDT).   "
69773|NCT02372539|"     Dexamethasone is a steroid commonly used for the prevention of chemotherapy-induced nausea     and vomiting (CINV). While effective, high dose dexamethasone is associated with numerous     side effects, even when used for a short duration. One such effect is elevated blood glucose,     or hyperglycemia. Current literature suggests increased risk of infection, poor wound     healing, and increased mortality in non-cancer surgical patients with steroid-induced     hyperglycemia. There is also evidence to support that elevations in blood glucose are     associated with worsened outcomes in cancer patients. Much of this data comes from cancer     patients that are treated in an inpatient setting where blood glucose is routinely checked.     Limited data is available describing the fluctuations in blood glucose following     dexamethasone administration in cancer patients being managed in an outpatient setting, such     as the Anschutz Cancer Pavilion (ACP) Infusion Clinic. This study aims to characterize the     effects dexamethasone has on blood glucose in cancer patients by utilizing Continuous Glucose     Monitoring (CGM) devices. These devices are minimally invasive, are FDA approved, and can     produce real-time data of blood glucose fluctuations over a course of 3-7 days. By inserting     the devices under the skin of the abdomen, the investigators can evaluate the temporal     relationship between glucose abnormalities and dexamethasone administration. Results from     this study will not only increase the knowledge base of dexamethasone-induced hyperglycemia     and identify patients at increased risk, but also allow future research to be conducted in     order to determine if standard protocols can proactively minimize steroid-induced glucose     fluctuations.   "
69774|NCT02372526|"     The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or     protein) that most potently stimulates the endogen secretion of different gut hormones     (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study     also includes a comparison of the secretion of gut hormones after oral intake of lipid with     or without a pancreatic lipase inhibitor.   "
69792|NCT02372292|"     Although the traditional determinant of renal dysfunction in heart failure was suggested as     decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the     association of persistent systemic venous congestion and kidney dysfunction. Relief of the     congestion has demonstrated to improve renal functions in decompensated heart failure. The     current trial was set up to investigate the changes of renal venous impedance and renal     arteriolar resistivity indices with diuretic therapy, in patients with congestive renal     failure. The investigators asked whether measurement of renal venous impedance index or renal     arteriolar resistivity index can guide the practice of diuretic therapy.   "
69823|NCT02371876|"     The purpose of this study was to determine if untrained subjects with diabetes can operate     the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose     results.   "
69775|NCT02372513|"     Cholesteryl Ester Storage Disease (CESD) is an autosomal recessive lysosomal storage disorder     (LSD) caused by mutations in the lysosomal acid lipase gene (LIPA) that markedly reduce     lysosomal acid lipase (LAL) activity, leading to the accumulation of lipids, predominately     cholesteryl esters and triglycerides, in various tissues and cell types. In the liver,     accumulation of lipids leads to diffuse microvesicular steatosis, which progresses to     fibrosis and ultimately, to micronodular cirrhosis. Patients typically present with     hepatomegaly, liver dysfunction, hepatic failure and type II hyperlipidemia. Although     hepatosteatosis is a typical finding, the liver biopsy diagnosis may be misclassified as     non-alcoholic fatty liver disease, non-alcoholic steatohepatitis or cryptogenic liver     disease. Biopsy and radiological findings are not considered diagnostic, but help to     suspicion of CESD. The definitive diagnosis is based on deficient LAL activity and/or LIPA     gene mutations.      CESD is pan-ethnic, however, the disease incidence is unknown. The estimated incidence of the     disease indicates that CESD should be largely underdiagnosed especially in European patients.     Elevation of serum transaminases, and hepatomegaly are early indications of liver impairment.     Therefore, CESD should be considered as a differential diagnosis in liver disease of unknown     origin.      To data, there is no study which evaluated the frequency of CESD in children with unexplained     transaminase elevation and/or organomegaly and/or chronic liver disease. The aim of this     prospective, multicenter and cross-sectional study is to investigate frequency of CESD in     children with unexplained transaminase elevation and/or and/or chronic liver disease and to     identify demographic and clinical features of CESD.   "
69776|NCT02372500|"     It is unknown whether post operative chewing gum will reduce post operative ileus. This study     is a randomised controlled trial that will determine whether chewing gum three times a day     following surgery will reduce post operative ileus. Time to passage of flatus will be used to     determine that incidence of ileus.   "
69777|NCT02372487|"     The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate     therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index     measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to     compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will     remain Sildenafil-naïve.   "
69778|NCT02372474|"     The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal     sc (MSC) therapy in women suffering from POF.   "
69779|NCT02372461|"     The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia     in pre-school children in resource limited settings are controversial both at an individual     and public health level. Most infections are viral or self-limiting and non-selective drug     treatment has contributed to the global epidemic of antibiotic resistance. There is no high     quality trial evidence in managing children with fast breathing in community settings and the     WHO itself has called for evidence on which to update guidance. The investigators proposed     non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum     settings in South Asia to address this deficit.   "
69780|NCT02372448|"     Patients eligibility to targeted therapies relies on a molecular test performed on a tumor     sample collected by biopsy. This invasive procedure is associated with a relative high risk     of morbidity and requires the intervention of a costly and important technical platform.     Thus, inoperable patients can be deprived from potentially more efficient therapies. A     liquid biopsy of Circulating Tumor Cells (CTCs) present in the blood and their molecular     characterization is an appealing alternative to meet an urgent need for these patients.     Moreover no CTC-based molecular test is currently routinely available.      The 5-year survival rate of patients with non-small cell lung carcinoma (NSCLC) is low.     Recent reports demonstrated that the detection of an ALK rearrangement in the tumor tissue     allows patients with late-stages NSCLC to benefit from crizotinib treatment.      However, 1) the detection of an ALK rearrangement is currently performed on small biopsies or     fine-needle aspirates and can be hindered by the limited tissue quantities available. Tumor     tissue is difficult to obtain in patients with advanced/metastatic lung cancer for whom     surgery is rarely a component of treatment. Finding alternative and more effective means of     diagnosing an ALK rearrangement are critical issues for identifying patients who may benefit     from treatment with crizotinib; 2) some patients develop resistance to crizotinib due to de     novo ALK mutations.      In this setting, circulating tumor cells (CTCs), which have been shown to be detectable by     ISET (Isolation by Size of Epithelial Tumor Cells) method in 80% to 100 % of late stages lung     cancer patients represent a non-invasive and easily accessible source of tumor material for     assessing ALK rearrangement and escaping mutations in a kinetic manner. The ISET method was     first published in 2000 and several independent teams have now established its high     sensitivity and specificity of ISET for NSCLC. With ISET, specificity can be achieved using     the same methods and criteria used by cytopathologists to diagnose solid tumors.      The high sensitivity and specificity of ISET are two essential starting points for the     feasibility of this present project. Low-throughput molecular characterization of CTCs     isolated by ISET has also been achieved. The remaining challenge consists in developing     high-throughput ISET-based molecular tests for personalized medicine that are transferable to     the clinics.      The Team 1 at the CHU de Nice and the Team 2 at the Gustave Roussy Institute have     demonstrated that the detection of an ALK rearrangement in CTC isolated by ISET is feasible     and consistent with results obtained in corresponding tumor tissues. In this context, the aim     of this project is to obtain 1) a definitive prospective clinical validation of the use of     CTC as an alternative to tumor tissue for ALK analysis-based patients stratification; 2) a     proof that escaping mutations can be detected early by kinetic analysis of CTC in patients     treated by crizotinib. ALK rearrangement will be prospectively investigated in CTCs isolated     by ISET at diagnosis and during follow up from patients with stage IIIb/IV lung cancer and de     novo mutations will be searched in patients with resistance to crizotinib. This study will     provide both clinical and economic benefit to targeted treatment of patients with advanced     lung cancer.      This project is strongly original as no CTC-based ALK rearrangement test has been     independently validated up to now with clinical samples. The development of non-invasive     theranostic test through the genetic analysis of CTCs is a clinically relevant goal for     non-invasive stratification of cancer patients, avoiding morbidity related to lung biopsy and     surgery. It would allow determining patient's eligibility to targeted therapies on a blood     sample analysis. CTC-based ALK test could be useful to guide the choice of ALK targeted     therapy in patients with lung cancer. Furthermore, developing biomarkers based on CTCs     analysis would open the way to the non-invasive follow up of aggressive cancers, early     detection of mutations associated with resistance to targeted therapies and tailoring     treatment to a real time analysis of the evolving tumor cell populations. This test is     expected to markedly improve patients' quality of life avoiding invasive diagnostic     procedures.   "
69781|NCT02372435|"     Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange Revision.      Patients will be randomized into 2 groups: the experimental Group will get a reimplantation     after a short interval (2-3 weeks) while the control Group after a long standard interval.      Primary objective of the study is Infection outcome. The infection-free status is defined     as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and     radiological signs of infection (e.g. no septic loosening).      Secondary objective is Functional outcome.The functional assessment will be performed using     joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD     HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM), patient     mobility / independency in daily life, subjective evaluation of pain using a visual analog     pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).   "
69782|NCT02372422|"     The purpose of this study is to determine if the use of routine transvaginal cervical length     ultrasound can be used to prevent preterm deliveries in twin gestations.   "
69787|NCT02372357|"     A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically     in children 13 years and younger, suffering from a hematologic malignancy.   "
69788|NCT02372344|"     The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of     AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male     Japanese subjects.   "
69789|NCT02372331|"     Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative     hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve     the restoration of,functional capacity after surgery on evidence-based medicine. The benefits     of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and     colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one     of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.      This study investigate the clinical effectiveness of ERAS on PD.   "
69790|NCT02372318|"     The aim of this study is to use functional Magnetic Resonance Imaging (fMRI) to measure     neural reactivity to alcohol-related and emotional cues in alcohol dependent subjects     following a single dose of the opioid receptor modulator nalmefene. The study will be done in     a cross over design with nalmefene versus placebo.   "
69791|NCT02372305|"     FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue     expanders and implants in place. There have been few chart review studies comparing outcomes     between the two materials in breast reconstruction. These studies have determined there is no     difference in complication rates between the two materials. However, there have never been     any active studies to date. This study will serve as a randomized controlled trial comparing     FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion     criteria to determine if either product is more suitable for use in breast reconstruction.     This will be performed by randomly assigning patients to receive either FlexHD or Alloderm.     Designated outcomes will be followed closely postoperatively. Outcomes will be statistically     analyzed to determine complication rates between FlexHD and Alloderm and thus which product     is better to use in breast reconstruction.   "
69793|NCT02372279|"     In a conventional in vitro fertilization (IVF) cycle, daily microscopic observation of     embryos outside the incubator to assess their morphology and establish a selection process is     performed. In this way it is possible to know which embryo or embryos have greater     implantantion capacity and will be transferred to the uterus to obtain a viable pregnancy.     However, these observations can produce deleterious effects on embryo development due to     changes in temperature, pH and osmolarity of the culture media, as well as a negative effect     of direct light microscope for observation. This project aims to test the hypothesis that     non-embryonic observation produces a beneficial effect on embryo quality until day 5 of     development (blastocyst stage) and, therefore, on rates of implantation and ongoing     gestation, compared with the conventional protocol of observations under the inverted     microscope on days two, three and five of development.   "
69794|NCT02372266|"     To determine the effect of a policy of early maternal-newborn infant discharge (12-24 hours)     with a home visit on admission to the Level II/III nursery and hospital admissions and     readmissions.   "
69795|NCT02372253|"     The overall purpose of this trial is to assess the efficacy and safety of using oral     verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the     patients' endogenous beta cell mass and insulin production. The objectives are therefore to     assess parameters of beta cell survival (including new biomarkers), insulin production and     glucose control and the feasibility of this approach and thereby provide the basis for     future, larger/expanded, longer-term verapamil studies and the off-label use of this approved     drug for T1D.   "
69796|NCT02372240|"     This is a phase 1/2 single arm study to determine the safety and efficacy of VLX1570 IV     infusion administered with low dose dexamethasone in patients with relapsed or relapsed and     refractory multiple myeloma.   "
69797|NCT02372227|"     The purpose of this study is to evaluate rising dose levels of VS-5584 administered in     combination with a fixed dose of VS-6063 in subjects with relapsed malignant mesothelioma to     determine a recommended Phase 2 dose (RP2D) for further development of this combination in     this indication.   "
69798|NCT02372214|"     The purpose of this study is to produce a patient-specific simulator for endovascular     infra-renal aneurysm repair training and than analyze the effect of simulator training on the     performance of vascular surgery residents.   "
69799|NCT02372201|"     Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI     microbiota and well being are analysed in subjects claiming GI inconveniences due to     Irritable Bowel Syndrome or food intolerances.   "
69800|NCT02372188|"     The purpose of this study is to elucidate whether bitter taste induced by the bitter compound     caffeine and the reduction of bitter taste by addition of the bitter masking compound     Homoeriodictyol sodium salt (HED) influence gastric acid secretion, subjective feelings of     hunger, ad libitum food intake and satiating hormones in healthy volunteers.   "
69801|NCT02372175|"     To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to     develop an appropriate challenge model. To this end, this first-in-human study will examine     the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product     and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.   "
69816|NCT02371967|"     Previous clinical trials have demonstrated the efficacy of Erivedge® in patients with     advanced Basal Cell Carcinoma (BCC) and Gorlin syndrome. This prospective, observational,     cohort study is designed to assess the effectiveness and safety outcomes of Erivedge® and to     assess actual day-to-day disease and patient management by the physician.   "
69817|NCT02371954|"     The study is a randomized pilot trial of a health promotion intervention in the prevention of     anxiety and depression in older Hispanics.   "
69818|NCT02371941|"     This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when     made into a viscous preparation for the treatment of eosinophilic esophagitis.   "
69802|NCT02372162|"     This single center, open-label, uncontrolled, non-randomized observational study in patients     with advanced HCC. The patients qualify either to a local treatment with transarterial     chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib.     The aim of this feasibility study is to get a comprehensive image and molecular fingerprint     of individual tumors, with the intention to govern therapy decisions. Furthermore, to improve     the care of patients that get progressive disease under treatment, the investigators have to     improve the investigators understanding of the development of therapy resistance, which will     improve patient care at the time point of progressive disease. Therefore, the data of 20     patients in each group will be used to identify molecular and / or image patterns, that can     be used to predict treatment responses and thus govern an optimized individual cancer     treatment for patients with advanced HCC.   "
69803|NCT02372149|"     The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an     effective intervention for patients with diabetes, peripheral neuropathy, and demyelination     on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months     each, with a 3 month washout period in between.   "
69804|NCT02372136|"     In preterm infants fed human milk, milk needs to be fortified to meet nutrient     recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily     human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate     and serum analyses).      The first specific aim will determine whether individualized and optimized nutrition during     hospitalization results in improved growth in the neonatal intensive care unit (NICU) in     extremely low gestational age (GA) neonates (ELGANs, <29 weeks) and in small for GA (SGA,     birth weight <10th percentile for GA) preterm infants compared with optimized nutrition.      The second specific aim will determine whether individualized and optimized nutrition in the     NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces     the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of     metabolic syndrome in the first 3 years of life.   "
69859|NCT02371408|"     The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination     with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4 patient     populations:        1. Treatment-naïve patients, with and without cirrhosis (Group 1)        2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2)        3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)   "
69860|NCT02371395|"     Worldwide, approximately 2 billion people live in areas at risk for malaria with morbidity     surpassing 250 million cases, with approximately 800,000 deaths, per year. Of the four     species of malaria parasites that cause human infection, P. falciparum is responsible for the     majority of severe malaria cases followed by P. vivax. Early and accurate diagnosis is     essential for prompt and correct treatment, which can reduce the death rate and interrupt     transmission. Currently, conventional methods for the diagnosis of malaria include     microscopic examination of thin and thick blood smears and rapid diagnostic tests (RDTs).     Light microscopy in practice typically detects parasitemia as low as 100 parasites/µl and it     can differentiate species. The advantage of microscopy includes the ability to estimate     parasitemia, the possibility to identify parasite stages, including gametocytes, and its low     cost. However, this method is labor intensive, difficult to standardize, and requires     well-trained microscopists. The majority of RDTs are based on detection of P. falciparum     histidine-rich protein 2 (HRP-2) antigen and do not detect all malaria species. RDTs that     detect lactose dehydrogenase (LDH) and aldolase generally broadly react with all four species     of malaria parasites and therefore cannot differentiate among the species although efforts     are underway to improve their performance for species detection. In settings where multiple     malaria species co-circulate, molecular methods may be more reliable than microscopy and RDTs     in accurately diagnosing the species of malaria parasites with low parasitemias. However,     conventional molecular methods, such as nested polymerase chain reaction (nested PCR) or     real-time PCR, are technically challenging and resource intensive and are generally     restricted to reference laboratories due to the need for well-equipped laboratories.     Recently, new molecular methods that can be used in field settings have been developed and     this opens up new opportunities for exploring molecular tools for malaria diagnosis in     endemic countries. With the objective of facilitating use of molecular tools for malaria     control programs, the malaria laboratory at the Centers for Disease Control and Prevention     (CDC) in Atlanta, USA developed a simple isothermal molecular method called Real-Time     Fluorescence Loop-Mediated Isothermal Amplification (RealAmp) for the diagnosis of malaria.     Currently, RealAmp primers exist for detecting the Plasmodium genus and the detection of P.     falciparum and P. vivax species. The RealAmp method has great potential as a molecular tool     for the diagnosis of malaria in the field (and other infections of major public health     impact, such as HIV and tuberculosis). It can provide an alternative to conventional     PCR-based diagnostic methods for field use in clinical and operational programs. The     objective of this proposal is to validate the sensitivity of RealAmp for detection of malaria     parasites in blood spots from patients with clinical diagnosis of malaria in two endemic     states of Brazil with co-circulation of P. falciparum and P. vivax. In this evaluation,     RealAmp and microscopic examination will be compared to a real-time PCR method as a reference     test.   "
69806|NCT02372110|"     The proposed study aims to investigate experimentally anxiety sensitivity and physiologic     sensations associated with anxiety using a paradigm combining hydrocortisone, caffeine, and a     set of social stress challenges. Following informed consent, participants will be instructed     to ingest either 400 milligrams of caffeine (an amount of caffeine roughly equivalent to that     in two 8 oz. cups of brewed coffee from Starbucks), and 20 milligrams of hydrocortisone or     two placebo capsules via stratified, random assignment. Physiologic and self-reported     measures of stress and anxiety will be taken.   "
69807|NCT02372097|"     The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25     milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.   "
69808|NCT02372084|"     To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in     subjects with mild, moderate and severe hepatic impairment compared with subjects with normal     hepatic function.   "
69809|NCT02372071|"     The primary objective of this study is to define the performance evaluation of BiliCare TcB     device to the gold standard bilirubin tests.   "
69810|NCT02372058|"     The primary objective of this study is to define the performance evaluation of BiliCare TcB     device to the gold standard bilirubin tests.   "
69811|NCT02372032|"     Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open     discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH.     Currently, several minimal invasive surgeries have been uesd widely. Percutaneous lumbar     discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and ozone     therapy combined other minimally invasive treatment could improve other minimally invasive     treatment's clinical effectiveness. The effectiveness of which has been proved to be     comparable to conventional open discectomy.      In this study, a single-blind randomized controlled trial will be performed to evaluate the     effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined     with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.      Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc     herniation undergoing PLD combined with ozone, and 2) patients diagnosed with lumbar disc     herniation undergoing PLD.      The primary endpoints of the study will be changes in in pain and functional status by the     Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability     Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as     measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include     response evaluation by MacNab response evaluation criteria as measured at pre- and     post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference in     the mean change from baseline between the two groups.      For the first time,the results of this trial will provide scientific evidence as to the     relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical     treatment for symptomatic lumbar disc herniation.   "
69812|NCT02372019|"     The purpose of this study is to determine whether briefly reactivating a fear memory 20     minutes prior to administering a social anxiety treatment will enhance the durability of     treatment effects.   "
69813|NCT02372006|"     Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion     cohort/Phase II part.      The trial will consist of 2 parts:        1. Dose finding part to determine the MTD        2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour          activity in included tumour types   "
69814|NCT02371993|"     Asthma in the elderly is poorly understood, as most studies have not included this patient     group. In a previous study of adults with asthma, choline supplementation had a positive     effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present     study is a randomized, double-blind, placebo-controlled, cross-over study of choline     supplementation. The investigators will study the effect of choline 650 mg taken orally twice     daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric     values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline     supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and     homocysteine levels.   "
69815|NCT02371980|"     The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg)     versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the     prevention of relapse in participants with major depressive disorder (MDD) who responded to     acute treatment with vortioxetine 10 mg.   "
69819|NCT02371928|"     This study is designed to investigate the efficacy and safety of a supervised neuromuscular     exercise program versus a standard home exercise program for patients with post-traumatic     symptomatic anterior shoulder instability.      Participants with at least one week of symptom duration are randomly assigned to either a     12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program     versus a standard HOMe EXercise (HOMEX) program.      The H1-hypothesis is that the SINEX program results in a greater increase in quality of life     and physical function than the HOMEX program at the primary endpoint at three months     follow-up from baseline   "
69820|NCT02371915|"     This project will be conducted in two phases. Phase 1: RA patients will be recruited to     participate in five repeated examinations occurring in one day to compare between and within     specialties, ensuring reasonable equivalency of examination findings. Phase 2: RA patients     living > 100 km from Saskatoon will be randomized to the intervention or control group, with     both groups having three follow-up appointments in 3-month intervals. The intervention group     will be evaluated by a physiotherapist supported by a rheumatologist through     videoconferencing, while the control group will continue to travel to Saskatoon for follow-up     care.   "
69821|NCT02371902|"     Chronic lateral epicondylitis is usually managed conservatively. The purpose of this     single-blinded, randomized, controlled study is to compare the clinical therapeutic effects     of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US)     therapy in chronic lateral epicondylitis (LE) during a period of 12 months.   "
69822|NCT02371889|"     The purpose of this study is to advance the effort to develop personalized pharmacotherapy     for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week,     prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy     of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD.     The investigators will stratify the randomization on genotype and oversample rs2832407*C     homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in     the four medication x genotype groups. The investigators will use daily data collection to     examine changes in relevant process variables (e.g., alcohol expectancies) and their     interaction with genotype and medication group as predictors of HD. The proposed study is     innovative in that it will be the first prospective test of a pharmacogenetic hypothesis     involving TOP; it will use daily reports to examine expectancies and how they interact with     medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is     either to reduce or stop drinking, which will increase the study's external validity.   "
69824|NCT02371863|"     Surgical treatment is the only approach with potentially defined clinical success for organic     mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful     MV repair is a clinical challenge in current practice. Especially when echo parameters at     rest are within or near normal ranges and patients presenting disproportionately symptomatic     in relation to the observed results. However, while MV regurgitation is a hemodynamic     disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks     information about hemodynamic changes. Physical stress echocardiography is a promising     technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic     changes. However, normal values for exercise echo are lacking in this postoperative patients     cohort. A prospective, observational trial to determine normal values in stress     echocardiographic parameters in asymptomatic patients after successful MV repair for organic     MV regurgitation, is therefore highly needed.      Purpose of the SEP- study is to determine normal values in stress echocardiographic     parameters in asymptomatic patients at least 6 months after successful MV repair for organic     MV regurgitation. These normal values for stress echo are of utmost importance to correctly     and accurate interpret stress echo results during postoperative follow-up and to improve     clinical decision making in patients post MV repair.   "
69825|NCT02371850|"     This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to     compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin     patch) nicotine skin patches in adult smokers.   "
69826|NCT02371837|"     The intervention will consist in a 6 week of pilates practice in older population to check     the prevention of fall effectiveness.   "
69827|NCT02371824|"     DCE-MRI were performed in sixty adults (hips and lumbar spine). For each region of interest     studied, the investigators determined the morphology of each time-concentration curve (TCC)     and calculated semi-quantitative and pharmacokinetic parameters: initial slope (IS), area     under the curve (AUC), time to peak (TTP), Ktrans, Kep and Ve. Clinical data were collected     anamnestically.   "
69828|NCT02371811|"     The investigators use v care during abdominal hysterectomy and evaluate its effect on     duration of operation time, surgical complications and vaginal length.   "
69829|NCT02371798|"     The purpose of this research study is to see if magnetic resonance imaging (MRI) with a     double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere     Disease.   "
69830|NCT02371785|"     This study evaluates the performance of the CorPath 200 System to deliver guide wires and     balloons to blockages in the arteries of the leg.   "
69831|NCT02371772|"     The aim of the study was to compare self-management of anticoagulant treatment with     conventional anticoagulant treatment in Norway.   "
69832|NCT02371759|"     The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15     mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral     local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable     cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate)     intraoral local anesthesia in patients with Diabetes mellitus type 2.   "
69833|NCT02371746|"     This is a multiple cohort study that will evaluate the safety and efficacy of ENV515     travoprost XR in patients with open-angle glaucoma or ocular hypertension.   "
70296|NCT02365662|"     This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2     dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221     in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal     Growth Factor Receptor (EGFR).   "
69837|NCT02371694|"     Background: Based on international evidence, current management of people with T1DM on     intensive insulin therapy (IIT) use algorithms based on the meal carbohydrate content (MCC)     to calculate the prandial insulin dose. Typically, these calculations do not take into     account the protein or fat content of the meal. There is a lack of clinical advice for     optimal management of high protein/fat meals due to a paucity of evidence regarding the     impact of protein/fat on glycaemic control.      Objective: To determine the mean glucose excursion from fasting (measured by continuous     glucose monitoring, CGMS) at each 30 minute interval over the 8 hour postprandial period for     each test condition. Protein effects will be looked at in a separate parallel study in     Australia.      Hypothesis: The fat content of a meal will cause a dose-response change in the postprandial     glucose concentration in children with T1DM.      Research Design and Methods: Randomised cross-over study involving thirty patients. Inclusion     criteria: T1DM >1 year, aged 8-18 years, with HbA1c <8% and BMI <91st centile, on intensive     insulin therapy. Participants will be given a test meal on 6 consecutive nights in random     order; 4 test meals varying in fat content, and one 20g carbohydrate test meal with zero fat     given as control meal. A CGMS will be used to assess glucose responses at 5 minute intervals     for 8 hours after test meal consumption. The relationship between the fat loads in the test     meals and the mean change in postprandial glucose concentration will be analysed and     described.      Conclusions: This study will determine whether fat causes dose dependent response in glucose     concentrations leading to refining the guidelines and possible adjustment of insulin doses     for the fat content of a meal.   "
69844|NCT02371603|"     This study will be a two-part with an open-label, single oral dose, two-way crossover study     design. Part A and Part B of the study are independent and may be conducted in parallel. The     Part A of the study will assess the effect of an oral dose of GSK1278863 on the     pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in     order to determine the potential for clinically-significant drug interactions with CYP2C8 and     OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8 inhibitor     (trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant metabolites.     Part A will be conducted in approximately 30 healthy subjects, having a randomized study     design. There will be approximate 7-day washout period between each dosing period. Part B     will be conducted in approximately 20 healthy subjects, having single sequence study design.     Follow up will be conducted within 7 to 10 days after the last dose in both Part A and B. The     total duration of a subject's involvement in the part A of the study will be approximately 8     weeks (Screening to Follow-up) and in part B will be approximately 7 weeks (Screening to     Follow-up).   "
71646|NCT02347969|"     The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary     supplement on skin radiance (clinical assessment) for 8 weeks.   "
69838|NCT02371681|"     Background:      - Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they     may spread these bacteria. Researchers are looking for new TB medicines. They want to find a     faster way to tell if a drug might combat TB.      Objective:      - To learn the effect of different anti-TB drugs on microbiological, radiographic and     immunologic markers in people with TB.      Eligibility:      - Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with     common TB medicines.      Design:        -  Participants will be admitted to the hospital for screening. They will have medical          history, physical exam, and chest radiograph. They will give blood, urine, and sputum          samples.        -  Participants will be put in 1 of 8 groups.        -  Participants will get one or a combination of TB medicines daily for about 14 days.        -  Each day, participants:        -  Will discuss side effects.        -  May have a physical exam.        -  Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make          them cough.        -  Participants will have blood taken 3-4 times during the study        -  Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed          Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure          TB disease in the lungs. It will be injected into a vein. Participants will lie in a          scanner that takes pictures.        -  Around study day 14, participants will leave the hospital. They will be referred to a          local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will          already be on these medicines and will have another FDG-PET/CT on day 28.        -  Participants will be in the study for up to 28 days.   "
69839|NCT02371668|"     Background:      - Researchers want to see if a new drug reduces flu disease in people treated with this drug     versus a placebo. The drug has an antibody that may help the immune system fight the flu.     Placebo is only sugar and water. All participants will get the flu virus. They may or may not     develop flu symptoms.      Objective:      - To see if the drug CR6261 reduces flu disease in people treated with this drug versus a     placebo.      Eligibility:      - Healthy nonsmokers ages 18 45.      Design:        -  Participants will be screened under a separate protocol.        -  Participants must use contraception or abstinence for several weeks before and after the          study. They must have no alcohol for 1 day before each visit. Any medicine must be          approved by the study doctor until after follow-up.        -  Participants will stay in a hospital isolation unit for at least 10 days.        -  They will have:        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Heart and lung test        -  Tests for drugs and alcohol        -  Throughout their stay, participants will:        -  Be closely watched by a medical team        -  Have nasal washes and swabs several times a day        -  Participants will have the flu virus sprayed in each nostril.        -  The next day, participants will get either study drug or placebo through a soft plastic          tube placed in a vein by needle. It will take 2 hours. They will not know which they          get.        -  Participants can go home after 10 days if they test negative for the flu 2 days in a          row.        -  Participants will have daily questionnaires at home and 2 follow-up visits over 2          months.   "
69840|NCT02371655|"     The aim of this study is to compare a new regimen of reduced bowel preparation that does not     include low fiber diet with another reduced bowel preparation including low-fiber diet.   "
69841|NCT02371642|"     The purpose of this project is to evaluate the utility of left ventricular strain as part of     the assessment of patients in the emergency department with acute heart failure (HF). The     central hypothesis of the investigation is that left ventricular strain will prove to be a     treatment response variable in patients with acute HF. Patients who are being treated for     acute HF with intravenous (IV) vasoactive medications (diuretics, vasodilators, inotropes)     will be eligible for enrollment. Patients who give written consent will receive a focused     bedside echocardiogram within 30 minutes of the initiation of therapy for acute HF. Images     that are captured during this echocardiogram will be interpreted by a blinded cardiologist     offline. 23 hours after this initial focused echocardiogram a member of the study team will     perform a follow-up focused echocardiogram, capturing the same images that will then be     interpreted by a blinded cardiologist offline.      Offline analysis will be performed using a proprietary software package from General Electric     called Automated Function Imaging (AFI). The AFI software will be used to calculate     longitudinal strain of the left ventricle (LV). Regional and global strain values will be     calculated for each focused echocardiogram for each subject. It is our hypothesis that LV     strain will demonstrate improvements from the initial echocardiogram to the follow-up     echocardiogram, unlike other echocardiographic indices in HF such as LV ejection fraction.   "
70297|NCT02365649|"     To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately     to severely active Crohn's Disease with a history of inadequate response to or intolerance to     Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.   "
69842|NCT02371629|"     This study is a post-authorization commitment to the European Medicines Agency (EMA). The     study serves to determine whether the treatment of patients with stable, symptomatic Chronic     Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and     safe. The efficacy and safety of the drug will be tested for twice daily dosing against once     daily dosing. The primary criterion to assess efficacy will be the trough FEV1 (defined as     mean evaluation at 23 h 15 min and 23 h 45 min post dose) measurements of patients who have     been treated for 12 weeks with NVA237 b.i.d versus those that have received NVA237 o.d.for 12     weeks.   "
69843|NCT02371616|"     An 8 week clinical study to evaluate the ability of an experimental dentifrice containing     calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine     hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate     and sodium monofluorophosphate.   "
69845|NCT02371590|"     This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated.     This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this     setting and induce complete clinical responses.   "
69846|NCT02371577|"     This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential     beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL)     and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic     lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise,     but not an iwCLL indication for CLL therapy (ie non-progressive disease).   "
69847|NCT02371564|"     Acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor     outcome, especially when intubation is required, thus underlining the importance of     optimizing non-invasive ventilatory support to avoid intubation. Practically, because of     treatment intolerance, non-invasive ventilation (NIV) cannot be administered 24-hour a day     for a long period of time and alternative solutions must be found to deliver oxygen as     efficiently as possible to allow NIV interruptions. High flow humidified oxygen therapy     (HFHO) consists of delivering a high-flow (15-60 L/minute) heated air-oxygen mixture (FIO2     21-100%) through a dedicated nasal cannula and can be interesting in this context. This well     tolerated technique improves oxygenation and decreases respiratory rate and dyspnea in     patients suffering from acute hypoxemic respiratory failure. In chronic COPD patients, using     HFHO can decrease respiratory rate and PaCO2. In COPD exacerbation, using HFHO can     conceptually be interesting. First, the high air-oxygen flow delivered well matches the     patient's inspiratory demand and should decrease the work of breathing. Second, as during     HFHO a high flow is continuously delivered in the airways, a wash-out of the anatomical dead     space should occur and CO2 clearance should be enhanced. Despite this strong physiological     rational for the use of HFHO in patients suffering from COPD exacerbation, the effects of     using HFHO instead of conventional oxygenotherapy in combination with non-invasive     ventilation (NIV) in this context has never been explored.      The main objective of the study is to explore the effects of using HFHO in combination with     NIV in acute COPD exacerbation and to assess the underlying mechanisms of action.   "
69848|NCT02371551|"     The primary concern in complex renal cysts (CRC) with malignant potential is the accurate     diagnosis and characterization. Patients with CRC have to undergo frequent imaging     surveillance (every 6-12 Mo), in which the progression suggests a neoplastic process. The     gold standard for establishing diagnosis and necessity for surgical intervention (i.e.     partial nephrectomy) is conventional computer tomography (CT) imaging. Its main drawback is     the radiation dose to the body and intravenous contrast media administration, which has a     risk of nephrotoxicity.      Magnetic resonance imaging (MRI) with special functional sequences (fMRI) and     contrast-enhanced ultrasonography (CEUS) allow measuring tissue blood flow and perfusion     characteristics without ionizing radiation or nephrotoxic contrast media. To compare the     diagnostic accuracy, sensitivity and specificity of CEUS/functional MRI versus the gold     standard CT, 60 patients with CRC will be evaluated using all these 3 modalities. The main     hypothesis is that fMRI and CEUS have equal accuracy with CT regarding diagnosis and     classification of CRC lesions.   "
69849|NCT02371538|"     Human Breast milk in young children with Norovirus Infection   "
69850|NCT02371525|"     To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for     pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men     (MSM).   "
69851|NCT02371512|"     Study to assess mitral valve therapy for advanced insufficiency of functional or ischemic     origin in patients with moderate-to-severe mitral regurgitation (MR) of primarily functional     pathology and reduced left ventricular function considered to be at high surgical risk   "
69852|NCT02371499|"     The aim of the study is to collect data for the assessment of the Lactobacillus casei DG     (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota     composition in patients with Irritable Bowel Syndrome.   "
70115|NCT02368054|"     Cervical conization is done for pre-cancer disease. The procedure is performed with local     anesthesia and general anesthesia. Local anesthesia is given by paracervical block, and     several different local anesthetics is being used including bupivacaine with and without     adrenaline. Adrenaline might reduce local bleeding and reduce toxicity of bupivacaine by     reducing absorption, but might affect cardiovascular function. This study will examine this     effect.   "
69853|NCT02371486|"     Cesarean scar defects (CSDs), i.e. deficient uterine scars following a cesarean section,     involve discontinuity at the site of a previous Cesarean section scar. These anatomical     defects have been reported to be associated with postmenstrual spotting, chronic pelvic pain     and infertility. Few case series have suggested improved fertility (most probably by     improving implantation of embryos) The aim of this study is to prospectively record embryonal     implantation rate during IVF in patients with CSDs, and to evaluate the effect of     hysteroscopic repair of CSDs on fetal implantation during IVF.   "
69854|NCT02371473|"     Acetazolamide improves central sleep apnea related to opium consumption.   "
69855|NCT02371460|"     The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or     DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their     infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks     post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an     omega-3 lipid, while the other half will receive a placebo.   "
69856|NCT02371447|"     This phase I/II trial will assess the safety and efficacy of intravesical instillation of     VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB     (transurethral resection of the bladder) and standard BCG therapy. In phase I part of the     trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II     dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D     to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of     VPM1002BC will be compared to results previously reported for BCG in a similar population.     The quality of life will be also investigated as a secondary endpoint. Additional immunology     assessments are foreseen as exploratory analyses to investigate the immunogenicity of     VPM1002BC.      The Phase II of the trial has been opened on 27.07.2016.   "
69857|NCT02371434|"     The aim of this trial is to collect evidence of the safety of administering autologous     CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant     recipients. In addition, the study will determine whether post-transplant nTregs infusion     allows a tapering of conventional maintenance immunosuppression within 60 weeks after     transplantation.   "
69858|NCT02371421|"     To pursue this objective, we will be measuring uric acid at baseline and post 14 days of     twice daily allopurinol therapy in 30 Hmong participants with documented gout or     hyperuricemia and known genotype for key renal transporters of uric acid.   "
69959|NCT02370108|"     This study is aimed to study the safety and feasibility of electrical muscle stimulation     (EMS) in suppression of tremor from various causes especially for rest tremor in Parkinson's     disease.   "
69863|NCT02371356|"     Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes     including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion     exists about if and how depression during pregnancy should be treated, given the unknown     risk-benefit profiles of various treatments. We propose to conduct a two-stage prospective     cohort study to determine if treating depression in pregnancy is effective in improving fetal     outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a     combination. The risk-benefit of the treatments will be examined separately for two     depression types: pregnant women with depression only and those with other psychiatric     comorbidities to evaluate possible differences in treatment effectiveness between the two     groups. Findings will provide answers to long standing stakeholder questions of how to treat     depression in pregnancy and which treatment is most effective with the best risk-benefit     profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or     LBW, thus, reducing infant mortality and morbidity, and medical costs.   "
69864|NCT02371343|"     Gestational diabetes is the development of diabetes during pregnancy. Left untreated,     gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications     for both mother and child. Some evidence suggesting omega-3 fatty acids might help protect     women from two serious pregnancy complications -- gestational diabetes and preeclampsia.     Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her     developing baby every advantage in life starting in-utero. Recent studies suggested that the     biologic processes underlying the observed associations may involve epigenetic changes,     specifically DNA methylation. In this study the investigators aimed to examine the effect of     fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and     insulin like growth factor 1 DNA methylation.   "
70124|NCT02367937|"     The aim of the study is to evaluate the effect of PRC-4016 at steady state on the     pharmacokinetics (PK) of cytochrome P450 (CYP) 3A substrates (midazolam, simvastatin), a     CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female     subjects.   "
69865|NCT02371330|"     This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100     (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding     Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth     weight <1500 grams and with different degrees of thrombocytopenia.      The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary     hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count     alone. A bleeding risk assessment marker could help physicians more accurately determine the     risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in     neonates with thrombocytopenia.   "
69866|NCT02371317|"     The purpose of this research study is to examine the efficacy of two stress management     interventions in reducing blood pressure (BP) in patients who have prehypertension (BP     between 120/80 and 139/89). It is expected that participants will be better able to control     their BP through reducing stress and increasing healthy lifestyle behaviors.   "
69867|NCT02371304|"     Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME).     Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days     mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch     Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated     with substantial loss of health related quality of life due to defecation disorders,     incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are     acceptable when radical surgery is the only option for cure. Advances in technology enabled     the development of local excision of early rectal cancer with precise endoluminal     microsurgery or local endoscopic excision resulting in a significant decrease in short- and     long term morbidity. However current evidence is of inadequate quality to conclude on the     oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and     tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment     of the excised tumor tissue provides the optimal information on tumor stage, tumor     characteristics and tumor differentiation, thereby it enables to predict the risk of     recurrence after local treatment alone. For early rectal cancers, with a low risk on     recurrence based on favourable tumor characteristics local excision is seen as safe and these     patients do not require an additional treatment. However, for patients with early rectal     cancer with a higher risk on recurrence based on tumor characteristics there is no consensus     on the additional treatment after local excision. According to the National guideline these     patients receive a TME procedure. However, for this subgroup of patients local treatment     followed by chemoradiotherapy might also be oncological safe. Current evidence is of     inadequate quality to be conclusive. For this subgroup of patients with early rectal cancer     with high risk tumorcharacteristics the TESAR trial is designed, in which patiens will be     randomised after local endoluminal excision between an additional TME-procedure (standard)     and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3     three year follow-up.   "
69868|NCT02371291|"     Our collection of memories for personal experiences plays an important role in shaping our     sense of who we are as people. These memories, termed autobiographical memories, can also be     helpful in social situations, for sharing the details of our experiences with other people,     reminiscing about pleasant times and solving problems by remembering what has and hasn't     worked in the past. Different types of autobiographical memory are helpful to us depending on     the particular situation the investigators are in at the time. Recent research has shown that     experiencing depressed mood can affect how we relate to our autobiographical memories, so     that instead of providing a rich source of personal information in a helpful and flexible     way, the types of memories that come to mind are more narrowly focused on difficult or     negative experiences. This can cause low mood to persist over time.      The purpose of this study is to test a newly-developed therapeutic training package for     depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to     autobiographical memories. The MemFlex programme consists of a one-to-one orientation session     with the researcher to introduce the training package, followed by a workbook that is     completed at home.   "
69880|NCT02371135|"     The purpose of this study is to understand the role bacteria that normally live in the colon     may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer.     The investigators will collect stool specimens as well as additional colon biopsy specimens     during the patient's scheduled colonoscopy procedure. The investigators will also collect a     questionnaire about diet and lifestyle. The samples will be used to study the impact of diet     on naturally-occurring oral and gut bacteria and their influences on human health including     risk of cancer.   "
69881|NCT02371122|"     The purpose of this study is to evaluate the effect of different spinal cord stimulation     settings in the treatment of leg pain. Subjects will receive a randomized order of four     different programmed stimulation settings for 3 weeks each followed by a fifth and final     setting.   "
70096|NCT02368301|"     The objective of this expanded access program is to provide treatment with elotuzumab in     combination with lenalidomide and dexamethasone for patients with relapsed or refractory     multiple myeloma at U.S. sites where licensed physicians determine clinical need.   "
69869|NCT02371278|"     The loss of muscle mass with aging is associated with a dysregulation of muscle protein     synthesis (MPS) that is generally characterized by a suppressed MPS response to protein     ingestion. This 'anabolic resistance' to protein feeding can be overcome with the ingestion     of larger protein servings (~0.4g/kg/meal, equivalent to ~ 30 - 40g/meal); however, older     adults would likely find it challenging to consume such quantities of protein on a per meal     basis.      The amino acid leucine has a unique role as a key 'activator' of MPS. Some research shows     that increasing the leucine content of a suboptimal dose of a protein supplement can enhance     the MPS response in older adults. However it is currently unknown whether the co-ingestion of     leucine with normal, mixed meals can increase MPS. Furthermore, it has been suggested that     leucine supplementation may only benefit older adults consuming suboptimal daily protein     intakes. Therefore, the purpose of the current study is to examine the impact of leucine     co-ingestion with mixed macronutrient meals on the myofibrillar protein synthetic response in     older men consuming daily protein intakes at or below the current recommendations. A further     objective is to determine whether the myofibrillar protein synthetic response to a session of     resistance exercise is enhanced by leucine supplementation with meals. The investigators     hypothesize that, in both the exercised and non-exercised condition, leucine co-ingestion at     meals will enhance integrative myofibrillar protein synthesis in older adults consuming lower     daily protein intakes, but will not augment MPS in those consuming higher daily protein. The     investigators further hypothesize that the influence of leucine supplementation on MPS will     be greater in the exercise condition than the non-exercise condition.   "
69870|NCT02371265|"     The overall objective of the study is to develop and test a pilot intervention in central     Mozambique to implement the new WHO Option B+ guidelines that seek to increase the     proportion of HIV-positive pregnant women in six antenatal care clinics who start     antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.   "
69871|NCT02371252|"     Osteoporosis is a common disease defined as a decrease in bone mass and strength which     increases risk of fragility fractures. This disorder may affecting health in many adults     which causing disability, morbidity, and mortality. Current first-line medical therapy is     bisphosphonates which alendronate is one of the most widely used. However, expenditure on     medicines is one of the major problem of inadequate access to treatment.      The investigators hypothesized that generic alendronate will have the same clinical efficacy     as the brand formulation. Therefore, the result of this study is extremely crucial. If     adequate efficacy of generic alendronate could be established and if it affords the same     safety profile as those of brand alendronate, the use of generic alendronate could then be     recommended.   "
70125|NCT02367924|"     Efficacy and safety of trabectedin in real-life practice, routinely used for the management     of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to     receive these drugs in Germany.      Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma,     after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.     Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.   "
69872|NCT02371239|"     Introduction: Changes in lifestyle are responsible for an important part of the type 2     diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly     on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity     (most often physical exercise). Recent studies suggest that sitting has negative metabolic     effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).      Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to     be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise,     LIPA might be a more feasible strategy. But, it remains to be determined whether reducing     sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less     blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether     these effects are independent of the increase in energy expenditure      Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2)     who perform no, or only little, exercise and who are treated with diet only or with oral     blood glucose lowering medication. They will perform three regimes of each four days: 1) a     sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of     the exercise regime will be identical to that of the sit less regime. Sitting, walking and     standing will be objectively measured by a 24 hour physical activity monitor. The energy     spent during exercise will be standardised and quantified by using a bicycle ergometer;     energy intake will be standardised as well. During each regime blood glucose will be measured     with a 24 hour continuous glucose sensor.   "
69873|NCT02371226|"     AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the     enzyme peripherally and to the brain, when administered intravenously. This study is a safety     and dose ranging study to obtain safety and exposure data, as well as information on the     biological activity of the investigational drug.   "
69874|NCT02371213|"     The purpose of the study is to determine whether social networking on mobile phone in     antenatal care health education is effective in the improvement of maternal and neonatal     outcomes compared with usual antenatal care.   "
69875|NCT02371200|"     Prospective study of an electromyography (EMG) based seizure detection and warning system for     detecting generalized tonic-clonic (GTC) seizures.   "
69876|NCT02371187|"     Exercise is frequently prescribed as a favorable lifestyle intervention to prevent/reverse     type 2 diabetes. It is also prescribed in addition to concurrent pharmacological treatment,     such as metformin. Recent data (animal and human) suggest that metformin may attenuate the     favorable benefits of exercise training. In light of the physiological mechanism of     Dapagliflozin (sodium-glucose co-transporter 2 (SGLT2) inhibition), one might speculate that     rather than inhibit, it will augment the favorable adaptations to exercise training.   "
69877|NCT02371174|"     The primary objective of the study is to clarify factors affecting the incidence of     peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be     enrolled in this study with 295 patients in the treatment group of primary or secondary     chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.   "
69878|NCT02371161|"     A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility     and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma     relapsed FIT or resistant to first line therapy.   "
69882|NCT02371109|"     Routine screening for gonorrhoea and chlamydia involves urine samples in males and selftaken     vulvovaginal swabs (VVSs) in females. As well as infecting the urethra (pee tube) and cervix     (neck of womb), gonorrhoea and chlamydia may also infect the rectum (bottom) and throat (both     called extragenital sites), often with no symptoms. In some people infection will be found at     more than one site, but in others it will only be in one, and if all anatomical sites are not     tested some infections will be missed. In certain women one third of infections may be     missed, in men who have sex with men (MSM) up to 90% may be missed, if extragenital swabs are     not taken. Currently, routine community testing does not include extragenital sites. Until     recently these samples could not easily be taken outside clinical settings (hospitals,     clinics or surgeries), but new DNA tests for gonorrhoea, called NAATs, now make this     possible.      However, they are expensive, and taking samples from extragenital sites would treble the     costs. We propose that swabs from the three sites per person are pooled and analysed together     rather than tested separately. This method would identify whether the person had the     infection but not the anatomical site; this would not alter the management of the individual.     Swabs from the rectum and throat have historically been taken by clinicians (doctors or     nurses). The main attraction of community screening is that it is client led using selftaken     samples. Recent studies suggest that selftaken swabs from the rectum and throat are     acceptable to clients and may be as good as swabs taken by clinicians, but the     costeffectiveness of this approach has not been investigated. Our aim is to establish whether     in MSM and females selftaken samples that are pooled and processed by NAATs are as effective     as the individual tests taken by clinicians.   "
69883|NCT02371096|"     Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be     compared in patients suffering from Rheumatoid Arthritis.   "
69884|NCT02371083|"     This is a prospective trial to investigate optimal timing of care for vaginal pessaries. A     vaginal pessary is a silicone device that is placed in the vagina to support the pelvic     organs of a woman who has pelvic organ prolapse. Some women are willing and able to remove     their own pessary on a regular basis. In women who are either unwilling or unable to remove     their own pessary, complete pessary care is provided in the urogynecology office. Complete     pessary care involves regular removal and cleaning of the pessary with a vaginal examination.     In our practice, the investigators typically remove vaginal pessaries and examine the vagina     every 3 months in patients for whom the investigators provide complete pessary care. Interval     of pessary removal varies widely between practitioners. In the literature, removal intervals     vary from weekly to yearly. In this study, the investigators will randomize participants to     pessary care with removal every 12 weeks or every 24 weeks.   "
69886|NCT02371057|"     Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone     secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint     destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the     colon. To have a greater effect on long-term outcomes this disease needs to be detected     early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be     able to detect these patients earlier and prevent late complications of the disease. At LTHT     the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance     to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show     approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to     warrant referral to the treatment group for continuous positive airway pressure (CPAP),     weight management, and occasionally mandibular adjustment.      Patients attending the sleep apnoea clinic either as new referral or for review will be asked     to participate in the proposed study. The study is cross-sectional in design incorporating     two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under     follow-up known to have sleep apnoea, and the second cohort those patients prospectively     attending the sleep apnoea clinic for assessment. If after an explanation of the study they     agree to participate blood will be taken for assessment of IGF-I and they will be asked to     complete a simple questionnaire.      The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate     five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are     elevated patients will be investigated further for the possibility of acromegaly. The     presence of biochemically proven acromegaly will be used to determine if the simple question     has sufficient sensitivity to use as a screening tool.   "
69887|NCT02371044|"     The investigators study aims to test the correlation between the CoaguChek point-of-care     testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently     approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to     determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in     real-life stroke patients.   "
69888|NCT02371031|"     This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for improving     surgical planning and providing non-invasive prognostic information in patients with gliomas     that have substantial non-enhancing regions. The results will be used to develop larger     adequately powered studies.   "
69889|NCT02371018|"     The purpose of this study is to examine the effect of nutritional supplementation during     hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover     design.   "
69890|NCT02371005|"     Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by     three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological     abnormalities. As all connective tissues can be affected, this condition has multiple effects     on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc patients.     Oral manifestations have a major impact on quality of life and require specific treatments     that should be performed as early as possible.      Widening of the periodontal ligament space, that seems to be linked to an increased collagen     synthesis, is one of the most common dental radiographic finding. However, this radiologic     sign has been mostly studied on two-dimensional radiographs. The investigators have recently     described in a patient suffering from SSc the existence of calcifications within the     periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al.,     Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been     observed before, could be part of the phenotypic spectrum of the disease, in particular when     dystrophic calcinosis is associated. They could furthermore constitute a specific feature of     SSc. However, this radiographic sign requires to be investigated in a largest number of     patients.      Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that     elevated CXCL4 serum levels correlate with disease complications, suggesting that this     molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate     with SSc severity. Gingival crevicular fluid can be easily collected from the gingival     crevice surrounding the teeth and constitute an indicator of local but also systemic     inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the     identification of specific SSc biomarkers and allow a better comprehension of oral     manifestations pathogenesis.      The aim of this case-control study is to characterize precisely the oral manifestations     associated with SSc within the National Referral Center for Rare Autoimmune Diseases     (Strasbourg, France) patient cohort in order to identify specific radiological, clinical     and/or biological signs. Some of them could be correlated to the severity or to the prognosis     of the disease. To the investigators knowledge it is the first study using tridimensional     CBCT approach.   "
69912|NCT02370719|"     The purpose of this study is to evaluate a patient-centered diabetes self-management mobile     application (app), which was developed with feedback from both patients and healthcare     providers. During the 12 month randomized control trial, participants in the intervention     group will be provided with a mobile phone and commercial home medical devices, such as a     weight scale, glucometer and activity monitor. The measurements taken from the medical     devices will wirelessly transfer to the mobile phone, where the app will assess the data and     provide patients with actionable self-management knowledge. The proposed intervention may be     helpful in increasing adherence to recommended self-care practices, improving self-efficacy,     and enhancing the overall patient experience.   "
80021|NCT02238470|"     The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the     risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite     oral anticoagulation   "
69891|NCT02370992|"     Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and     intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this     technique in patients who have had a previous transurethral resection of the prostate gland     (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when     the technique was being developed in the 1980s suggested that there was a higher incidence of     urinary incontinence after brachytherapy if there had been a previous TURP. It is however     clear that with increasing experience many centres offer this treatment to patients who have     had previous TURP, using various parameters to select patients including time from the TURP     and persence or absence of a significant cavity within the gland on MRI scanning. There has     been no systematic study of I125 brachytherapy after TURP in the current era which might     address and inform the practice for future patient. Hence this study is designed to formally     assess the safety of I125 brachytherapy after previous TURP.   "
69892|NCT02370979|"     This is a multi-center prospective study. The primary objective of DRONE study is to     investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48     (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG     pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.   "
69893|NCT02370966|"     The purpose of this study is to determine whether intake of berry powder effective in the     treatment of systemic and oral inflammation.   "
69894|NCT02370953|"     OVERVIEW Cataract is a clouding of the crystalline lens which causes vision loss and     blindness if untreated. Cataract surgery is the most frequently performed surgical     intervention in medicine with an incidence of 880 surgeries per 100.000 population in 2010     amounting to a total number of over 160.000 surgeries per year in the Netherlands.      Approximately 22% of patients with cataract have a substantial pre-existing corneal     astigmatism. Toric IOLs provide the opportunity to correct pre-existing astigmatism, offering     the patients optimum distance vision without the use of spectacles or contact lenses. Toric     IOLs are increasingly used in cataract and refractive surgery.      Since the introduction of toric intraocular lenses (IOLs) in the treatment of cataract in     patients with pre-existing corneal astigmatism, numerous studies have shown the importance of     accurate positioning of the toric IOL to the intended alignment axis. An error of 5º in toric     IOL alignment will decrease the anticipated effect by 17% and thus misalignment will decrease     the effectiveness of the astigmatism treatment. There are several methods used to align the     toric IOL at the intended axis. Most of these use a 3-step ink-marking procedure and are     performed manually. Clinical study showed an average error of 5º in toric IOL alignment when     using this method.      Two new tools that have recently been introduced to the market are the VERION Measurement     Module and VERION Digital Marker. Together, these tools provide integrated digital guidance     for alignment of toric IOLs and they have the potential to eliminate the error in horizontal     axis marking and the alignment axis marking error. This will lead to an improved visual     outcome. So far, there are no published studies using the VERION tools for toric IOL     alignment in cataract surgery. Therefore, the investigators will perform this randomized     control trial.      MAIN HYPOTHESIS      The investigators hypothesise that cataract surgery with the implantation of a toric IOL,     when using the VERION-tools, compared to manual ink-marking, in patients with corneal     astigmatism will lead to:      - An increase in accuracy in toric IOL alignment      OBJECTIVES      Primary Objective:      The primary objective of the study is to compare the accuracy in toric IOL alignment when     using the VERION-tools for alignment of the toric IOL or the conventional manual ink-marking     procedure.      Other hypotheses and objectives are available in the detailed description.   "
69895|NCT02370940|"     The purpose of this study is to investigate whether regular consumption of phytate dampens     its negative effect on nonheme iron absorption.   "
69896|NCT02370927|"     The objectives are to test the acute effects of different cereals containing pulse     ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of     blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two     hours following the exercise session. The investigators hypothesize that consumption of     cereals containing pulse ingredients 60 minutes before exercise will increase aerobic     endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory     quotient), and a reduction in lactate production during compared to the same exercise session     following the ingestion of a non-pulse food. The investigators also hypothesize that     consumption of cereals containing pulse ingredients will lead to lower blood glucose,     insulin, appetite and food intake, suggesting lower calorie compensation, following a     60-minute aerobic exercise session compared to the same exercise session following the     ingestion of a non-pulse food.   "
69897|NCT02370914|"     The purpose of this study is to establish and evaluate a distinctive signal for concussion.   "
69898|NCT02370901|"     Babies 4-7 months of age with positional plagiocephaly will be treated with repositional     techniques verse helmet therapy. The helmet therapy children will be fitted a helmet at     Westcoast Brace and Limb and monitored during treatment to ensure proper fitting of helmet.     The repositioning children's parents will given instructions on how to perform neck     stretching exercises and repositioning techniques and monitored during treatment. The     anthropometric measurements will be done by licensed orthotist at monthly intervals for a     total of six months of treatment. Before treatment, 6 months, 12 months, and 24 months from     treatment all of the children will be scanned by Star Scanner (Orthomerica) to provide     objective measurement of the cranial vault asymmetry and index.   "
69899|NCT02370888|"     The purpose of this study is to determine the maximum tolerated dose, dose limiting side     effects, and the safety of increasing doses of lenalidomide in patients with AML and MDS who     have a small amount of detectable disease after allogeneic stem cell transplant.   "
69900|NCT02370875|"     Benign essential blepharospasm (BEB) is a functionally disabling focal dystonia. Botulinum     neurotoxin (BoNT) therapy is suboptimal in many BEB patients. Repetitious transcranial     magnetic stimulation (rTMS) therapy is a promising noninvasive therapy and has shown positive     benefits in BEB. rTMS therapy can be easily combined with BoNT injections to enhance the     effects of BoNT in BEB.   "
69913|NCT02370706|"     This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the     triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for the     doublets, PIM447 plus ruxolitinib, and LEE011 plus ruxolitinib, in patients with     myelofibrosis (MF). Each regimen will be assessed for safety, tolerability, pharmacokinetics     (PK) and pharmacodynamic effects, and preliminary anti-myelofibrosis activity, including     changes in spleen volume, JAK2V617F allele burden, and hematologic response.   "
69914|NCT02370693|"     The purpose of this study is to look at whether bortezomib, mycophenolate or the combination     of both is better to treat scarring of the lung caused by Systemic Sclerosis.   "
69915|NCT02370680|"     This study is being conducted to evaluate the safety and the length of effect on platelet     build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or     subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and     cardiovascular disease or multiple risk factors of developing cardiovascular disease.   "
80044|NCT02238171|"     To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the     treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice   "
69901|NCT02370862|"     Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most     individuals with SCI. Previous studies have reported that the average time to complete a BC     routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1     hour. In past studies, the investigators have shown that a medication called neostigmine     (NEO) combined with a medication called glycopyrrolate (GLY) can increase bowel activity and     thus, promote bowel movement. The investigators have successfully used this medication with     traditional and novel methods of colonoscopic preparations, and have shown that it improves     the quality of these preparations. In this Phase I, proof of concept pilot study, the     investigators propose to study the effectiveness of this medicine when it is delivered     through the skin. In order to make delivery more efficient, the investigators will be using a     technique called iontophoresis, which uses a mild electric current to drive the drug through     the surface of the skin. The instrument includes an electrode containing the active agent     (delivers charge) and an oppositely charged electrode (receives charge) which will be placed     on the surface of the skin. The study design will consist of a screening visit to determine     each individual's response to a previously established IV dose of NEO and GLY, followed by a     dose titration study (two visits) of iontophoresed NEO and GLY. Study visits will be     separated by no less than 2 days and no more than 14 days.      If this delivery method is shown to be effective, it may represent a way to vastly improve     the clinical utility of this medication by allowing for needle-free self administration, and     expanding the clinical indication to routine, at home bowel care.   "
69902|NCT02370849|"     In this open-label, single-center, small sample size, randomised, parallel-group, controlled     study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS     chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two     patients are required and randomly assigned (1:1) to each group.      The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for     advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.   "
69903|NCT02370836|"     This study evaluates that effects of psycho-oncological education on distress and quality of     life in solid tumor cancer patients who have completed chemotherapy with curative intent.     Half of the participants will received a psycho-oncological educational intervention while     the other half will receive usual care.   "
69904|NCT02370823|"     The primary objective of this study is to determine the levels of proteins and/or cellular     components of the synovial fluid that are indicative of microenvironment phenotypes of the     osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks     post-Regenexx® SD treatment.   "
69905|NCT02370810|"     The purpose of this study is to determine the feasibility and effectiveness of a CBT-based     internet intervention for adults with tinnitus in the United Kingdom   "
69906|NCT02370797|"     The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron     Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good     or better results in preventing recurrence of local breast cancer, cosmetic appearance and     early and late side effects.   "
69907|NCT02370784|"     The purpose of this study is to learn about the effect atorvastatin on blood vessel function     and Raynaud symptoms in patients with early diffuse systemic sclerosis.      Systemic sclerosis is a disease characterized by blood vessel injury, immune system     activation and fibrosis. Blood vessel injury is thought to be important early in the disease.     Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger and toe     ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is recognized     to have many effects beyond cholesterol reduction. These include improvement of blood vessel     function and reduction of fibrosis. We hypothesize that treatment with atorvastatin over 16     weeks will improve blood vessel function and Raynaud symptom in patients with early diffuse     systemic sclerosis. We hope that by targeting therapy early in the disease we may delay blood     vessel changes and improve Raynaud symptoms.   "
69908|NCT02370771|"     Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the     elderly population. Usually considered as a minor illness, it nevertheless leads to an     important functional impairment. The mechanism of this disease is still poorly known.     Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from     which mechanisms may differ.      Methods:      This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in     consultation of rheumatology and plastic surgery in Rouen University Hospital.      Two groups of patients will be studied: 20 patients with non erosive subtype of hand     osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.      A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic     analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.   "
69909|NCT02370758|"     This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated     immunity can be used to determine whether patients who complete a course of therapy for CMV     viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will     receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their     prophylaxis stopped.   "
69910|NCT02370745|"     This study has two protocols the aims of which are:        1. To identify age-related effects of AA on incretin secretion and whether and to what          extent AA exhibit a true incretin effect (gut- mediated increases in plasma insulin) in          younger individuals. (Protocol 1)        2. To define the extra-pancreatic ''novel'', insulin independent effects of glucagon like          peptide-1 (GLP-1) on postprandial muscle protein and glucose metabolism and          microvascular blood flow. (Protocol 2)   "
69911|NCT02370732|"     The proposed project will help to understand the changes in reinforcement and impairment     experienced by Roux en Y bariatric surgery (RYGB) patients who consume alcohol. In this study     the investigators propose to investigate RYGB patients with a prospective, longitudinal     design. Investigators will examine driving impairment before and after surgery as well as     study cognitive changes and reinforcement changes that may occur in RYGB patients while     consuming alcohol. Finally, investigators aim to better characterize the changes that occur     in the pharmacokinetics of alcohol following bariatric surgery and examine key variables     which may play a role in the development in alcohol use disorders.   "
80045|NCT02238158|"     To obtain further information on the tolerability and efficacy of Atrovent® inhalets in long     term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice   "
69916|NCT02370667|"     Prescribing exercise for people with painful knee osteoarthritis (OA) is essential for pain     management, improved function, and chronic disease prevention. Exercise that decreases joint     exposure to damaging loading while eliciting adequate muscular activation for strength     improvements is ideal. The purpose of this 3-arm RCT is to compare mobility, strength, pain,     and MRI outcomes between the low-loading biomechanical exercise program (BE), a traditional     exercise program for knee OA (TE), and a control group completing meditation classes (M).   "
69917|NCT02370654|"     This study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise     in pulmonary rehabilitation for COPD patients. Half of participants will receive the     Chen-style Tai Chi intervention, while the other half will receive the conventional exercise     intervention. Both groups will receive the same eduction and support during pulmonary     rehabilitation.   "
69918|NCT02370641|"     A total of 20 individuals, 10 urolithin excretors and 10 nonexcretors will be enrolled. The     excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine     after one dose of POMx. A blood sample and stool sample will be obtained before administering     the extract. Subjects will be asked to consume one capsule of 1000 mg POMx daily for 4 weeks.     At day 28, a blood sample, 24 hour urine sample will be obtained, and the stool collected by     the participant in the prior 24 hours will be returned to the Center. Blood and urine     urolithin, ellagic acid levels and stool bacteria enumeration and identification (including     pyrosequencing) will be measured with the samples collected. A stool DNA sample will be     preserved and frozen for potential future measurement of gene-nutrient interaction in     pomegranate metabolism.      Throughout the study participants will be instructed not to consume pomegranate products,     walnuts, or polyphenol-rich fruits ((strawberry, raspberry etc) or juices drawn from a list     used in prior studies. The study will be carried out in accordance with the guidelines of the     Human Subjects Protection Committee of the University of California, Los Angeles. All     subjects will give written informed consent before the study begins. Participants will be     recruited by advertisement in the local newspaper in the Los Angeles Area close to UCLA.   "
70126|NCT02367911|"     This Phase 3 study has been designed to determine and compare the efficacy and safety of     122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque     psoriasis.   "
69919|NCT02370628|"     The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing     percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful     vertebral compression fractures.      The treatment offered for vertebral compression fractures (VCFs) in the interventional arm of     the trial is vertebroplasty, which will be performed in accordance with the standardized     protocol of the Canadian Association of Radiologists. Patients in the control arm will     receive facet block, where a long-acting local anesthetic agent and corticosteroids are     injected in the spinal articular facets at the affected level.   "
69920|NCT02370615|"     The purpose of this study is to evaluate the effect of repeated-dose administration of     itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose     administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy Japanese     adult males.   "
69921|NCT02370602|"     The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain     following a single dose of TAK-063.   "
69922|NCT02370589|"     This is a randomized, observer-blind, placebo-controlled trial in male and female subjects     ≥18 to <50 years of age. Subjects will be healthy adults based on history, physical     examination, and baseline clinical laboratory testing.      Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups.      Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate     deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with     or without Matrix-M adjuvant), in a 0.5mL injection volume.   "
69923|NCT02370576|"     Determination of incidence and prevalence of PTSD and other types of psychopathology (such as     anxiety and affective disorders) after traumatic birth experiences and elucidation of salient     risk factors in the local population sample- by prospective follow-up.   "
69924|NCT02370563|"     The aim of this study is to explore the efficacy of 18F-FSPG in the detection of primary or     metastatic brain cancer lesions confirmed by a standard of truth, preferably histology. This     is a single center, open labelled, non-randomized study. A total of 30 subjects with brain     tumor or brain metastases will be enrolled. All different stages of malignancies will be     recruited, including those with different types of pathologies and grades, and newly     diagnosed or recurrent disease.   "
69925|NCT02370550|"     The purpose of this large multicenter, randomized, double-blinded, controlled clinical study     is to investigate the efficacy and safety of Cyclosporin A for primary Sjogren's syndrome     associated pneumonitis(pSS-IP), which has important implications for the establishment of     standardized diagnosis and treatment of pSS-IP.   "
69926|NCT02370537|"     This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase     II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients     with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of     EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott Healthcare     Products Ltd) following a single oral dose in patients with different degrees of PEI.   "
69927|NCT02370524|"     The primary objective of this exploratory imaging study is to further characterize [18F]T807,     an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker     indicative of neurodegeneration in conditions such as AD).   "
69928|NCT02370511|"     The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN     XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific     mitral valve disease with severe mitral annular calcification who are not candidates for     standard mitral valve surgery.   "
69929|NCT02370498|"     This is a study for participants with advanced gastric or gastroesophageal junction     adenocarcinoma who have had tumor progression after first-line treatment with platinum and     fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab     (MK-3475) prolongs progression free survival (PFS) and overall survival (OS) for participants     with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.      As of 20-March-2016, enrollment will be limited to PD-L1 positive participants.   "
69930|NCT02370485|"     The purpose of this study is to evaluate how much of the LY2801653 drug is available in the     body when given in 2 different formulations with and without a meal to healthy participants     who are not able to have children. In addition, this study will measure how much of the drug     gets into the blood stream and how long it takes the body to get rid of it. Information about     any side effects that may occur will also be collected. The study will last about 27 days.     Screening is required within 28 days prior to the start of the study.   "
69931|NCT02370472|"     The use of Ultrasound Guided Regional Anaesthesia (USRA) has increased over the last decade.     Theoretically, ultrasound imaging may increase efficacy and safety by allowing visualization     of the needle pathway and local anaesthetic spread around the nerve. In addition to knowledge     of anatomy and general principles of ultrasonography, USRA requires learning new skills such     as image interpretation, needle-beam alignment, and needle trajectory tracking. The hand-eye     coordination required during needle advancement requires practice to master because the     needle must be properly aligned with the ultrasound probe in order to maintain the needle     path in the beam at all times. Adding to the difficulty, hand and needle movements can occur     in three axes, but an ultrasound image is seen in only two dimensions. Since the ability to     acquire the necessary skills to perform USRA is subjective and not yet validated, it is     difficult to recommend a single, effective training pathway.      Currently, the only method of supervised training before performing an USRA procedure on an     actual patient involves practicing needle insertion in a phantom or cadaver. Studies     assessing the impact of learning using these methods are lacking. It is possible that some     practitioners may choose alternative one-off learning methods. Such methods are not     standardized and are thus difficult to evaluate.   "
69941|NCT02370342|"     This clinical trial studies a type of ultrasound called robot-assisted laparoscopic     high-intensity focused ultrasound for performing thermal ablative therapy, or sound wave     therapy, in treating patients with small kidney masses undergoing partial removal of the     kidney. The robot-assisted ultrasound probe takes images of the kidney to help doctors locate     the mass. The probe then uses high frequency sound waves to target and ablate (or destroy)     the kidney mass, which may be a cancerous tumor or benign tissue. Surgery is then performed     to remove the part of the kidney with the mass. Robot-assisted laparoscopic high-intensity     focused ultrasound for thermal ablative therapy may be safer and help doctors see the tumor     better when performing kidney surgery.   "
69932|NCT02370459|"     The University of North Carolina will test the effectiveness of the Centers for Disease     Control and Prevention's AFIX model for increasing HPV vaccination coverage among     adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality     improvement consultations that immunization specialists from state health departments deliver     to vaccine providers in primary care settings. Using immunization registry data, the     specialist evaluates the clinic's vaccination coverage and delivers education on best     practices to improve coverage. We will compare changes in HPV vaccination coverage before and     after consultations for high-volume pediatric and family medicine clinics across three study     conditions: traditional consultations (in-person group), virtual consultations (webinar     group), or no consultations (control group). In each participating state, 30 clinics will be     randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics     overall. The primary objective of this study is to compare the change in coverage for HPV     vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up.     Secondarily, we will compare the change in coverage for other vaccines and age groups.   "
69933|NCT02370446|"     The purpose of this study is to see if using the MedLog is helpful to patients. Since the     investigators do not yet know if this MedLog is helpful, some patients will receive it and     some will receive our standard of care. The investigators want to know whether providing     patients with this additional information is helpful and if having this additional     information about their treatment schedule has an effect on their quality of life.   "
69934|NCT02370433|"     Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most     individuals with SCI. Previous studies have reported that the average time to complete a BC     routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1     hour. In past studies, the investigators have shown that a medication called neostigmine can     increase bowel activity and thus, promote bowel movement. The investigators have successfully     used this medication with traditional and novel methods of colonoscopic preparations, and     have shown that it improves the quality of these preparations. In this study, we would like     to test the applicability of this medication to bowel care routines.      The investigators believe that the addition of this medication to the beginning of regular     bowel regiments will significantly decrease the time and effort needed to complete BC, thus     improving patient perception of their BC routines and quality of life. SCI individuals     followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted     on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such     inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient     undergo BC routines assisted by the inpatient care team. BC routines are typically performed     every other day, or thrice weekly (Monday, Wednesday, Friday) in Blue Rooms located on the     inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use     of assistive medications or devices, and completeness of bowel care are documented in the     patients' electronic medical chart (CPRS) by care providers. The investigators propose to     perform the described protocol in individuals who have been admitted to the hospital for     routine care and are otherwise healthy. In doing so, the investigators can ensure that     patients are vigilantly monitored during each BC session, and that any changes in BC pattern     are accurately observed and documented. Furthermore, by performing these procedures on an     inpatient basis, study investigators can ensure the consistency of care and daily routine,     allowing for better control of study conditions.   "
69935|NCT02370420|"     The investigators include patients attending the outpatient clinic in the area of Orthopedics     and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which     treatment is medical. Patients will be divided into two groups. In both groups, they will be     given verbal, clear and detailed information on the approach to follow, the intra-articular     application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first     group will be held single application, while in the second group three applications will be     made at an interval of two weeks each. Both groups will be assessed before and after     application, together with outpatient follow-up by the SF-12, WOMAC and Visual Analogue     Scale.   "
69936|NCT02370407|"     This is a randomized controlled trial that will randomize 40 surgical skill naive medical     students to practice on a robotic simulator or laparoscopic simulator after first completing     a baseline evaluation on both surgical simulation platforms. Medical students will be     evaluated again after 10 practice sessions on the laparoscopic or robotic platforms to assess     transferability of skills between the surgical simulation platforms.   "
80046|NCT02238145|"     To obtain further information on the tolerability and efficacy of Atrovent® inhaletten® in     the treatment of chronic obstructive airways disease under conditions of daily practice   "
69937|NCT02370394|"     The study will develop and assess an innovative, high-reach, easily implementable, low-cost     computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that will     address known barriers in early identification and intervention with perinatal women with IPV     seeking treatment for mental illness.   "
69938|NCT02370381|"     Nose bleeding (epistaxis) is a common emergency. It is often difficult to estimate blood loss     and the current hemoglobin of patients. In patients with oral anticoagulation, it is     important to measure the level of hemodilution. Several situations with the importance of the     fast determination of these parameters have been identified in previous studies [1,2]. The     blood sampling from the venous punction is the standard in these investigations. However,     this requires the corresponding painful puncture and also the time required at the     laboratory.      Since many patients present themselves with active bleeding, it is obvious that this blood     could be used for determining the following parameters: Hemoglobin and INR/Quick. The nose     blood can be analyzed with commercial rapid test devices. If these devices could generate     same or similar results and after further validation of the method, painful punctures could     be waived.   "
69939|NCT02370368|"     This study will examine the effects of six week dance training, using the Xbox Kinect Just     Dance 2014 programme, on the agility scores along with general and hamstring flexibility and     extensibility of the hip flexor. The effects of the dance programme will be compared with     those of proven agility training techniques (ladder drills).   "
69940|NCT02370355|"     This research trial studies molecular characterization of circulating tumor cells (CTCs) and     circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients     with prostate cancer that has spread to other places in the body and/or has not responded to     previous treatment with hormones. Studying samples of blood and plasma collected from     patients with prostate cancer before, during, and/or after treatment in the laboratory may     help doctors learn more about changes that occur in DNA and identify the development of drug     resistance.   "
69942|NCT02370329|"     This pilot phase II trial studies P1101 (polyethyleneglycol [PEG]-proline-interferon     alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a     substance that can improve the body's natural response and may slow the growth of     myelofibrosis.   "
70127|NCT02367898|"     The purpose of this study is to measure the efficacy of an online cognitive training program     against an active control condition in a large, randomized trial.   "
70128|NCT02367885|"     The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular     injection of TAK-850 in healthy pediatric Japanese participants.   "
69943|NCT02370316|"     The present randomised clinical trial aims to assess the clinical and neurobiological changes     following Metacognitive Interpersonal Therapy -standard approach (MIT-SA) compared with     Clinical Structured Treatment (CST) derived from specific recommendations in APA guidelines     for borderline personality disorder (BPD). The investigators will assess clinical changes in     metacognitive abilities and in emotion regulation and changes in brain activation patterns at     the resting state and while they view emotional pictures. A multidimensional assessment will     be performed at the baseline, at 6, 12, 18 months. The investigators will take structural and     functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N=30) and CST-treated BPD     (N=30) at baseline and after treatment, as well as a group of 30 healthy and unrelated     volunteers that will be scanned once for comparison. Furthermore, blood analyses will be done     in order to assess level of BDNF and some hormone levels (oxytocin and vasopressin) before     and after treatments.   "
69944|NCT02370303|"     The purpose of this study is to isolate and measure circulating tumor cells in the blood     stream to advance detection of cancer and treatment monitoring. In this study, the     investigators will utilize the novel technology for circulating tumor cell detection in order     to evaluate their presence in patients with lung cancer.   "
69945|NCT02370290|"     This pilot research trial studies quantitative imaging metrics derived from contrast enhanced     computed tomography (CECT) in enhancing assessment of disease status in patients with kidney     cancer. Quantitative imaging is the extraction of quantifiable features from radiological     images for the assessment of disease status. Collecting quantitative imaging metrics from     CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage)     and assess treatment response and prognosis in cancer imaging.   "
69946|NCT02370277|"     This pilot research trial studies the effects of chemotherapy on intestinal     bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in     intestinal microbiota may be associated with weight gain in patients treated with     chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the     types and quantity of bacterial composition in the stool of breast cancer patients treated     with chemotherapy may help determine whether body weight and composition are associated with     changes in the intestinal microbiota and allow doctors to plan better treatment to prevent     weight gain and possibly disease recurrence.   "
69947|NCT02370264|"     This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck     (upper extremity) function and quality of life after treatment in patients with breast     cancer. Patients may experience arms, shoulder, and neck impairments that negatively affect     their functioning and quality of life after cancer-related treatment. Studying upper     extremity function and quality of life in patients after breast cancer treatment may help     doctors determine the prevalence and severity of long-term functional impairments and the     relationship between the perception of impairments due to breast cancer treatment and its'     impact on quality of life.   "
69948|NCT02370251|"     This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at     treating liver disease in children on long-term IV nutrition.   "
69956|NCT02370147|"     A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be     proposed in outpatient department clinics of People's Liberation Army General Hospital in     Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief     face-to-face individual smoking reduction intervention lasted about one minute, and five     follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very     brief face-to-face individual exercise and dietetic advices lasted for the same intervention     time as SRI, and also five follow-up interventions lasted for one minute each with different     intervention contents.   "
69949|NCT02370238|"     Reparixin oral tablets are being tested as a CSC targeting agent in patients with metastatic     non- human epidermal growth factor receptor (HER2)-amplified BC. An open label Phase 1b     clinical study (REP0111) is ongoing (enrollment completed) in five US sites, under IND #     112502, to test safety, tolerability, pharmacokinetics and detect early signs of antitumor     activity of increasing doses of reparixin oral tablets in combination with a fixed dose of     weekly paclitaxel. The study has demonstrated safety and tolerability of the combination     across the three dose levels explored and recorded objective responses in the published range     for single agent weekly paclitaxel in the target population. The highest dose level explored     (i.e., 1200 mg t.i.d.) was identified as the recommended phase 2 dose. Durable responses have     been recorded in patients with TNBC.      The current phase 2 study thus aims to evaluate the Progression Free Survival of patients     with metastatic TNBC [newly diagnosed metastatic or relapsed following (neo)adjuvant     chemotherapy] receiving reparixin in combination with paclitaxel versus paclitaxel alone.   "
69950|NCT02370225|"     The purpose of this sudy is to investigate the effects of a regular aerobic exercise on     aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease     activity in women with pSS.   "
69951|NCT02370212|"     Recent evidence suggests that high -intensity interval training (HIIT) may be an effective     strategy to improve cardiorespiratory fitness, exercise performance, and insulin sensitivity.     In addition, creatine (Cr), a nitrogen- containing compound, is widely used to enhance high     intensity exercise performance. A seminal study demonstrated that the muscle content of Cr     and phosphocreatine (PCr) can be elevated by exogenous Cr. Oral intake of Cr increases the     concentration in blood and muscle, and part of the increased muscle Cr is transformed to PCr     (a process catalyzed by Cr kinase). Cr supplementation increases total Cr (TCr = Cr + PCr) by     ~20%, with the PCr component accounting for 10% of the increase.      Combining HIIT and Cr is intriguing for two reasons; first, Cr supplementation improves     performance through increasing PCr, PCr recovery, and muscle buffering which may facilitate     higher training intensities and therefore greater training adaptations. Secondly, both Cr and     HIIT have individually been shown to increase GLUT 4 and insulin sensitivity, suggesting that     Cr supplementation may be an adjunct to HIIT for improving glucose control. To date, there     have only been two studies investigating the performance effects of Cr combined with HIIT     with preliminary positive results. No studies have examined the impact of combined Cr + HIIT     on outcomes related to insulin sensitivity. Therefore, the purpose of this research is to     examine the combined effects of Cr and HIIT on performance and insulin sensitivity as     determined via an oral glucose tolerance test (OGTT) in young healthy adults.   "
69952|NCT02370199|"     This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes     in healthy adults. All participants will receive red light to their leg. They will also     receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.   "
69974|NCT02369900|"     The main purpose of this study is to determine the effects of controlling the heart rate of     patients with septic shock using an intravenous medication called esmolol.   "
70129|NCT02367872|"     The purpose of this study is to examine the effects of renal and hepatic impairment on     TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with     renal or hepatic impairment.   "
69953|NCT02370186|"     Severe sepsis results in over 300,000 Emergency Department (ED) visits and 215,000 deaths     annually in the US. Currently there are no effective drug therapies for sepsis. High density     lipoprotein (HDL) has antioxidant, anti-inflammatory, and antithrombotic properties and is     protective in sepsis. Its functions in sepsis are primarily mediated by its main     apolipoprotein, Apo-A1, that: 1) neutralize potent bacterial toxins, 2) protect blood vessel     walls from damage, 3) prevent tissue damage through antioxidant properties, and 4) mediate     thymocyte apoptosis (critical for survival) and endogenous corticosteroid release. However,     recent literature presents inconsistent data on HDL functionality and shows that HDL becomes     non-functional during acute inflammatory states called dysfunctional HDL (Dys-HDL). Several     causes for Dys-HDL have been hypothesized including the presence of Apo A1 polymorphisms,     which may worsen the pathologic inflammatory response in sepsis and have been demonstrated in     early sepsis, making Dys-HDL an unstudied potential early marker. This project aims to: 1)     determine the presence of Dys-HDL in adult patients with early severe sepsis who present to     the ED (Dys-HDL will be tested using a novel cell free assay and HDL Inflammatory Index will     be measured), and 2) examine the relationship between Dys-HDL and cumulative organ     dysfunction via Sequential Organ Failure Assessment (SOFA) score. Results of this study could     establish Dys-HDL as an early disease marker for sepsis which is influential in the     development of sepsis-induced organ dysfunction.   "
69954|NCT02370173|"     Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major     problem among service members returning from combat deployments. The proposed study aims to     test a novel, inexpensive, and easy to use approach to improving sleep among service members     with PTSD.      Primary outcome measures will include not only PTSD symptom improvement but also include     neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The     proposal is firmly grounded in the emerging scientific literature regarding sleep, light     exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light     therapy is effective for improving mood and fatigue, and our pilot data further suggest that     this treatment may be effective for improving daytime sleepiness and brain functioning in     brain injured individuals. Thus, this intervention, in our own research and in the work of     others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a     vital component of recovery in these service members. Our approach would directly address     this issue. Our preliminary data have shown that this approach is extremely well tolerated     and is effective for improving sleep, mood, cognitive performance, and brain function among     individuals with brain injuries.      Finally, the potential impact of this study is high because of the capability of     transitioning the research to direct clinical application almost immediately. If the bright     light treatment is demonstrated as effective, this approach would be readily available for     nearly immediate large-scale implementation, as the devices have been widely used for years     in other contexts, are already safety tested, and commercially available from several     manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would     be high and immediate.   "
69955|NCT02370160|"     This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+)     and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase     I dose/schedule finding component using the maximum tolerated dose identified during the     previous phase I study, but with a higher number of doses and a two-stage phase II extension     component to confirm safety and make a preliminary determination of the activity level by     disease using the dose identified in phase I.   "
69960|NCT02370095|"     Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a     number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung     function and breathlessness. There are no pharmacological treatments approved for the     treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil sodium     by inhalation for preventing the progression of acute hypoxemic respiratory failure to     positive pressure ventilation and/or ARDS in patients at high risk.   "
69961|NCT02370082|"     The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance     System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance     during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate     and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The SAVI     SCOUT has been 510K cleared.      The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a non-palpable     abnormality as localized by radiographic or ultrasound methods. In this study, the ability of     the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead of the standard     technique of wire localization.   "
69975|NCT02369887|"     This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM     and TG at five health facilities in four provinces of Thailand. Each participant will be     followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4     counts, retention in care, and ART adherence at the study clinics, at the study clinics     combined, and national data (if available) will be compared with rates after implementation     of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence     and incidence. This study will use similar objectives, indicators, and procedures as those     used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three     tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations     Implementation Science (KPIS) funding through United States Agency for International     Development (USAID), in community-based centers, allowing comparison of uptake and follow-up     of MSM and TG using the Test and Treat strategy in a variety of settings.   "
69962|NCT02370069|"     Patients with severe chronic kidney disease (CKD) are at a great risk for infection due to     their immune system being suppressed. Pneumococcal infection is particularly common and often     results in death due to inflammation of lung (pneumonia) or the whole body (sepsis). This     infection can be prevented using vaccines which help build protective immunity. The currently     recommended pneumococcal vaccine (Pneumovax), however, is often inefficient in this group of     patients. There is thus an urgent need to improve the existing vaccination policy.      The goal of this research is to optimize pneumococcal vaccination of patients with severe     CKD. Many patients suffering from CKD have already been vaccinated with Pneumovax. Because     this vaccine has low immunogenicity in immunocompromised individuals, they may still develop     infection. A new vaccine, Prevnar13, has superior immunogenicity and has been recently     approved for immunization. There is, however, no specific policy regarding immunization of     adult CKD patients, and it is furthermore unknown whether previous Pneumovax immunization     negatively affects immune response to Prevnar13.      In order to test whether previous immunization with Pneumovax affects the immune response of     severe CKD patients to Prevnar 13, the investigators will immunize two groups of adult stage     4 and 5 CKD patients with one dose of Prevnar 13 and will assess their initial immunological     response, its longevity, and vaccine safety. The first group will consist of patients who had     been previously immunized with Pneumovax, and the second group will include participants with     no history of pneumococcal vaccination.      Antibody levels and opsonophagocytic activity (OPA) will be quantified. The longevity of the     immune response will be assessed. As a secondary objective, the immune response will be     analyzed in the context of demographic and clinical characteristics of the vaccinated     participants.   "
69963|NCT02370056|"     The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater     accuracy and speed in manual skills, translating to decreased operative time, reduced     learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic     approach using 3D visualization in the surgical treatment of ulcerative colitis   "
69964|NCT02370043|"     The purpose of this study is to assess the safety, tolerability, and the effect of food on     KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different     dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels     may be studied, in two distinct groups or cohorts.   "
69965|NCT02370030|"     Triple blind placebo-controlled study to determine if administering citrulline in patients     with sepsis and severe sepsis slows progression to multiple organ failure and death,     measuring biomarkers of endothelial dysfunction. Patients are divided into placebo or     citrulline and followed up for 1 month.   "
69966|NCT02370017|"     The object of this study is to identify the combined effect of ANKL and doublet chemotherapy     in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy     as the 3rd and 4th courses in the patients who get stable response after x2 induction as the     first line chemotherapy. ANKL (2x10*9) from peripheral blood 32ml is administered rapidly iv     12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by     chemotherapeutic agent is maintained. After 4th course, response evaluation is done by     Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more partial response (PR,     increased by 15% or more from historical control 25%) is the expected target and Simon's two     stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)   "
69967|NCT02370004|"     The aim of the study is proof of concept and to establish the feasibility of performing a     study of resistive flexibility and strength training (RFST) in patients with asthma, with the     future goal of designing a larger randomized trial to test the hypothesis that RFST leads to     greater improvement in asthma symptoms, pulmonary function tests, range of motion and     connective tissue mobility compared with a control conventional physical therapy     intervention.   "
69968|NCT02369991|"     This study assesses the long-term results of compound tibial reconstruction treated with a     microvascular latissimus dorsi flap and bone transport technique during the last 25 year in     Helsinki University central Hospital.   "
69984|NCT02369770|"     This research study will conduct a double-blind randomized clinical trial of an intensive     motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation     robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments,     and improve balance and gait functions. This clinical trial will be conducted on the study     and control groups of acute stroke survivors.   "
69985|NCT02369757|"     The main objective is to evaluate the impact of the recruitment and training of a     peer-navigator on the participation rate of colorectal cancer screening among underserved     area. The role of the navigator is to establish an intervention culturally-tailored to the     inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the     inhabitants to complementary exams, if needed.   "
69969|NCT02369978|"     This randomized, blind, parallel-group trial will evaluate the efficacy and safety of     Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite     Trypanosoma cruzi.      The investigators will test whether NFX is an effective trypanocidal agent (by comparison     with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related     and safety outcomes.      Individuals found seropositive and without clinical signs of dilated cardiomyopathy will     receive either of the active treatments or matching placebo. Participants allocated to NFX or     BZN will receive either a 60-day (full-dose) or a 120-day (half-dose) active treatment,     whereas the control group will receive placebo for 120 days. There will be thus four arms of     active treatment (NFX60, NFX120, BZN60 and BZN120), and a fifth control arm receiving placebo     (1:1:1:1:1 allocation ratio) where every participant in the trial will take 120 days of study     drug (the groups receiving full-dose will complete a 120-day masked treatment with placebo).      The study plans to enroll 500 participants from Colombia (in two different geographical     areas) and Argentina, in order to explore regional differences in the treatment effects.   "
69970|NCT02369965|"     The purpose of this study is to determine the efficacy and safety of albuvirtide plus     lopinavir-ritonavir in HIV-1-infected adults who failed first-line antiretroviral therapy.   "
69971|NCT02369939|"     Randomized study to investigate the efficacy of deep regional hyperthermia in patients with     anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.   "
69972|NCT02369926|"     This study aims to calibrate the Multiple Sclerosis Functional Composite (MSFC) for home     implementation in a phase 2 trial of lisinopril in multiple sclerosis. In this initial stage,     participants are required to travel to the study site one day a week for three weeks to     complete the MSFC. They are also required to complete the MSFC at home once weekly for three     weeks using remote sensing technology and video conferencing.   "
69973|NCT02369913|"     This proposal is designed to test the hypothesis that humans shift to reliance on ketone     bodies as a cardiac fuel source during the development of HF. The investigator also propose     that this shift to ketone utilization can be detected by metabolomic profiling of blood.      Specific Aim 1: To determine if the failing human heart exhibits increased extraction of     blood-borne ketone bodies. Ketone bodies will be measured in coronary sinus, arterial, and     central venous blood samples to determine AV differences. The HF group will be comprised of     patients undergoing cardiac resynchronization therapy with an implantable     cardioverter-defibrillator. The Control group will be compromised of patients without     evidence of structural heart disease who are undergoing catheter ablation for     supraventricular tachycardia.      Specific Aim 2: To determine whether blood samples from humans with HF display metabolomic     signatures indicative of increased myocardial ketone body utilization. Quantitative targeted     metabolomics will be performed on the samples described in Aim 1 to determine if metabolite     markers (e.g. C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with     increased myocardial ketone body oxidation in animal models are increased in the human HF     group compared to the controls.   "
69977|NCT02369861|"     Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history,     ophthalmic examination to include the status of their ocular structure and function and     evaluation of tear production. Blood will be blood drawn for complete blood count and     chemistry panel. They will also have a urinalysis and pregnancy test in women of     child-bearing potential.      Subjects will have a two week run-in period in which they use artificial tears. If their     Dry Eye signs and symptoms do not improve significantly, they will be enrolled and will     receive study drug.      Safety evaluation includes assessment of the structure and function of the eyes including     retina examination and corrected visual acuity.      Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of     two treatment arms, ACCS or artificial tears eye drops. The randomization scheme is 1:1     ACCS:artificial tears. Subjects will self-administer their eye drops four times each day.      Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week     zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each     visit. The baseline eye tests and lab work will be repeated after the treatment phase of the     study at the end of week six. Following 6 weeks of treatment, the subjects will be followed     for 4 additional weeks.   "
69978|NCT02369848|"     Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical     study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in     subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm     reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated     to generate sonic shockwave energy within the target treatment site and disrupt calcium     within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low     balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to     yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up     rate.   "
69979|NCT02369835|"     This randomized phase III trial studies how well modified Dakin's solution works in reducing     radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with     head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce     inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.   "
69980|NCT02369822|"     There are no solid treatment guidelines for idiopathic intractable epilepsy in children. The     investigators propose that vitamin C being an antioxidant will improve seizure frequency and     EEG in children with idiopathic intractable epilepsy.   "
69981|NCT02369809|"     Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in     daily clinical practice and obtain information about the quality of life in patients treated     with Neovasculgen®.   "
69982|NCT02369796|"     The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of     subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448     to overweight/obese males with hypogonadotropic hypogonadism.   "
69983|NCT02369783|"     The main objective of the study is to validate a methodology with Psychometric tool to     measure levels of patients social fragility.      This tool will be dematerialized on a tablet. The answers will be then processed by a     decision support algorithm, which automatically send an alert to detection of social     fragility of the patient to the nurse navigators.   "
69986|NCT02369744|"     Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency     Department (ED) visits. These stones can get caught in the ureter (the tube connecting the     kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as     the obstructing stone meets certain conditions and the patient isn't too sick, the patient is     usually sent home to try and pass the stone without surgery. This treatment is known as     medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin,     which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a     drug in the same class of tamsulosin, but which is thought to have a more selective action     and a quicker onset, which would theoretically make it better for aiding in kidney stone     passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs     to see how quickly they result in stone passage. Subjects are patients presenting to the ED     with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study     intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is     that silodosin will have decreased time to stone passage compared to tamsulosin.      Subjects who qualify and consent are randomized to a two-week course of either silodosin or     tamsulosin. They are also given prescriptions for standard of care medications for pain and     nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind     them of their follow-up appointment, ask about adverse events, and determine if their stone     has passed. They have a follow-up visit with study staff at the end of their two week     treatment to collect their pain diary, pill count, adverse events, and to determine if their     stone has passed. Study participation ends after this follow-up visit.   "
69987|NCT02369731|"     This study is being performed as a post-approval safety study (PASS), per the     Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to     gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in     routine clinical practice.   "
69988|NCT02369718|"     Cochlear implant microphones are subject to aging and dirtying. The evolution may affect     their efficiency. Several signal coding strategies are used in cochlear implants and their     behaviour may be more or less affected by the aging process. In this work the investigators     wish to assess this phenomenon.   "
69989|NCT02369705|"     Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional     full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a     synchronized manner.      The PSG data will be scored manually by a trained polysomnographic scorer, according to     standard criteria for this clinical routine.      The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep     stages, snoring (optional) and body position (optional), in addition to parameters specific     to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and     will be compared to the PSG's manual scoring which serves as a Gold Standard.   "
69990|NCT02369692|"     The purpose of this prospective study is to gather procedural use and safety data on the     initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr and     Vascular Accessories 6 Fr.      This study will focus on, but not be limited to, endovascular embolization procedures in the     peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine     arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial     chemoembolization (TACE).      The data will be analyzed for medical education, societal presentation and/or publication by     the investigator.   "
69991|NCT02369679|"     Treatment of lymphedema is based on a combined program called complex decongestive therapy.     The components of the complex decongestive therapy are skin care, kinesiotherapy, manual     lymphatic drainage and compression. The compression with multilayer bandage has proved to be     the most effective of these therapies when analyzed separately.The multilayer bandage     produces a gradient compression on the limb where distal pressure is higher than proximal     pressure. Several materials are needed for the multilayer bandage, including tubular bandage     lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages     to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a     Velcro system.      The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid)     with the multilayer compression bandages in the treatment of the upper limb lymphedema.   "
69992|NCT02369666|"     The primary purpose of this study is to determine if 4-weeks ingestion of LycoRed (code     40051) product containing a mixture of tomato extract with carotenoids and phytochemicals by     endurance runners attenuates inflammation, muscle damage and soreness, and oxidative stress     during 24 hours recovery from a 2-h running bout.   "
69994|NCT02369640|"     During the past decades, simulation-based training has become essential for making trainees     fit for clinical practice. Traditionally, trainees are instructed to practice with as few     errors as possible during simulation-based training. However, recent evidence from the field     of psychology suggests that transfer of learning may improve if trainees are encouraged to     commit errors during training. The aim of this study is to assess on performances with real     patients the effect of error-management instructions compared to error-avoidance instructions     during simulation-based virtual reality ultrasound training.      This study is planned as a randomized controlled trial. Participants include medical students     with no prior simulation practice at the fifth or sixth year of medical school. All     participants receive 3 hours simulation-based ultrasound training focusing on fetal weight     estimation. The participants (N=60) are randomized into two groups: Participants in group 1     are instructed to follow the simulator program step-by-step to achieve the highest possible     simulator metric scores by making as few errors as possible. Participants in group 2 are     instructed to experiment and explore and to deliberately make errors during training. A     simulation-based pre- and post-test is administered before and after training.      Participants are scheduled to perform a transfer test seven to ten days after simulation     training. The transfer test consists of fetal weight estimation on a real patient. The     primary outcome is weight deviation of participant measurements compared to expert findings.     Secondary outcomes include performance assessments of pre-, post- and transfer test     performances by blinded ultrasound experts using the Objective Structured Assessment of     Ultrasound Skills (OSAUS) scale. Using an alpha level of 0.05, an effect size of 0.80, and a     power of 0.80, 25 participants are needed in the two study groups. Loss to follow-up of up to     20% of study participants is anticipated, resulting in 30 participants in each study group.   "
69995|NCT02369627|"     The purpose of this study is to evaluate a new approach to increase HIV testing among young     adult Black, Hispanic, and white men-who-have-sex-with-men (MSM). In this randomized,     controlled trial, participants will be assigned to one of three HIV testing groups: (1) rapid     HIV self-testing group (OraQuick® In-home HIV Test), (2) conventional home-based HIV     testing group (Home Access Express), and (3) community/medical-based HIV testing group. Upon     completion of testing, participants will receive a questionnaire to evaluate their HIV     testing experience, and also inquire about recommendations for future testing. Study     participants will also have the option to refer other study eligible males to the study via     email.   "
69996|NCT02369614|"     This is a randomized placebo/sham controlled, double-blind study investigating the efficacy     of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham     rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.   "
70013|NCT02369393|"     To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical     Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with     depressive symptomatology with a wait list control group (WL) in Spanish population.   "
69997|NCT02369601|"     Premature rupture of membranes refers to the rupture of the fetal membranes prior to the     onset of labor. Premature rupture of membranes is associated with a number of neonatal and     maternal complications including an increased incidence of perinatal mortality and     intra-amniotic infection. There is a need for improved diagnostic testing because of     limitations of the current methods.      PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding     protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.   "
69998|NCT02369588|"     This study tests the effect of serving larger portions of all foods in a meal on the outcome     of food and energy intake. Using a crossover design, participants are served the meal once a     week for four weeks and the portion sizes are varied at each meal. Some of the foods served     at the meal are low in calorie density (calories per gram) and some are higher in calorie     density. The aim is to determine whether intake in response to larger portions differs     depending on characteristics of the subjects or of the foods.   "
69999|NCT02369575|"     The purpose of this study is to investigate new therapies for advanced lung disease.   "
70000|NCT02369562|"     The purpose of this retrospective study is to investigate and identify factors associated     with the failure of dental implants within the population rehabilitated with dental implants     at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).   "
70001|NCT02369549|"     An investigator initiated pilot trial: two arm, double blind, placebo controlled, randomized,     parallel group of approximately 750 patients with chronic kidney disease, and who have     evidence of overt proteinuria, will be treated with micro-particle curcumin versus placebo     over 24 weeks from start of the investigational medication date (approximately 6 months) to     test whether curcumin can slow chronic kidney disease progression in patients. Three 30 mg     capsules of micro-particle curcumin will be self-administered once daily in the morning to     determine the the safety and efficacy of curcumin relative to placebo in reducing     albuminuria, reducing urinary interleukin-18 and slowing the loss of eGFR.   "
70130|NCT02367859|"     This pilot clinical trial studies dabrafenib in treating patients with ameloblastoma and a     specific mutation (change) in the BRAF gene. Dabrafenib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
70002|NCT02369536|"     The objective of this study is to provide clinical data to support the effectiveness of a     mixture of ingredients of natural origin, suitably selected and packaged, in the protection     from liver damage, in subjects with NAFLD.      Study design: double-blind, randomized, multicentre trial, placebo-controlled on two parallel     groups.      The study participants are healthy volunteers, since they do not have nor had any     liver-related clinical symptom, but simply laboratory (plasma levels greater than normal for     at least one of the liver parameters -aspartate aminotransferase AST, alanine     aminotransferase ALT or γ -glutamyltranspeptidase γ-GT) or instrumental (ultrasonographic     abnormalities of steatosic liver) tests altered as compared to normal ranges.      Three months treatment with the nutraceutical mixture or placebo. Outcomes tested before and     at the end of treatment - 3 months).   "
70004|NCT02369510|"     The purpose of this study is to investigate whether the addition of a medication called     epinephrine to spinal medications prolongs the duration of the anesthesia. The medication     standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain     medication (morphine). These medications typically last about 2 hours. The investigators want     to determine if adding epinephrine to the spinal medications prolongs the anesthetic without     side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean     section. Epinephrine is known to prolong the action of some local anesthetics, but the     investigators want to specifically study combining it with the medications the investigators     use regularly for cesarean section.      You may qualify to take part in this research study because you are having a repeat cesarean     section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want     to determine if epinephrine will prolong the anesthetic.   "
70005|NCT02369497|"     This is a prospective study on the Ascension HRA device to collect data to assess the safety     and effectiveness of the HRA.   "
70006|NCT02369484|"     The purpose of this study is to investigate the control of disease in pretreated patients     with advanced non small cell lung cancer (NSCLC) harbouring HER2 exon 20 mutations as well as     the safety and tolerability (how severe the side effects are) of the treatment with afatinib.   "
70007|NCT02369471|"     To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo,     in the presence of other antiepileptic drugs (AEDs).   "
70008|NCT02369458|"     No agent is known to have efficacy in patients with incurable HNSCC that progressed with     prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this     trial. Based on the preclinical and clinical data presented, the investigators propose that     mitomycin C will have anti-tumor activity in these patients.   "
70009|NCT02369445|"     The purpose of this pilot study is to compare an innovative toilet training strategy with a     standard behavioral intervention in children with autism spectrum disorder (ASD), as     implemented by teachers in the school setting. Thirty classrooms with a total of 60 children     with ASD (aged 3 - 10 years) will be enrolled in the study. Each classroom will be randomly     assigned to either the innovative strategy group or the standard behavioral group. The     innovative strategy employs an electronic moisture pager that sends a signal when the child     begins having a urine accident. Outcome measures include rate of urine accidents and rate of     toilet use in the two groups.   "
70010|NCT02369432|"     This proof of concept study aims to assess in patients suffering from atopic dermatitis if     polymeric microparticles reach the pilosebaceous follicles of inflamed skin.   "
70011|NCT02369419|"     Background: The cardiac resynchronization therapy (CRT) has been shown to improve symptoms     and outcome of patients with congestive heart failure (HF), and depressed left ventricular     ejection fraction (LVEF < 35 %). The rate of non-responders to CRT is estimated at 30 %. Yet,     the impact of frailty on the response to CRT has not been studied, until now.      Purpose : To assess the impact of frailty in the elderly, on the response to CRT.   "
70012|NCT02369406|"     The overall objective of this study is to determine whether very early antiretroviral     treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and     maintains immune responses, potentially allowing future periods off ART.   "
70014|NCT02369380|"     Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration     of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal     filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel     shoes   "
70015|NCT02369367|"     The goal of this clinical research study is to find the highest tolerable dose of     lenalidomide combined with Camptosar (irinotecan) as well as to see if this drug combination     can help control malignant gliomas.      Researchers will also study if a special magnetic resonance imaging (MRI) technique (dynamic     MRI scan) is useful in looking at the effect of treatment on the tumor. Another goal is to     learn the effect of lenalidomide on tumor tissue in patients who need surgery for the     disease.      This record represents the Phase II portion of original Phase I/II study (see registration     record NCT00671801).   "
70016|NCT02369354|"     Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education,     behavior, and financial support interventions to improve consideration of live kidney     transplantation/live kidney donation among African Americans on the deceased kidney waiting     list. We hypothesize that interventions to help potential kidney transplant recipients and     their potential donors overcome barriers to live donor kidney transplant (including family     discussions, financial, or logistical barriers) could improve potential recipients' receipt     of live kidney transplants.The main outcomes of TALKS will include whether potential     recipients (1) have potential live donors call into the transplant center on their behalves;     (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney     transplant.   "
70018|NCT02369328|"     Stroke is the second most frequent causes of mortality in the word after cardiovascular     disease and the most frequent cause of disability. The majority of strokes are ischemic     (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not     exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long     term functional recovery is largely dependent from the ability of the brain to reorganize.     Conventional magnetic resonance imaging represents the most sensitive tool to diagnose stroke     at the acute phase. However, up to now, no imaging tool is available to determine the time of     stroke onset. Moreover, no imaging tool is available to precisely quantify the functional and     structural plasticity mechanisms occurring after stroke. The main objective of the present     study is to test the accuracy of sodium MRI to determine the time of stroke onset. The     secondary objectives of the study are to determine the ability of non-conventional MRI     techniques to quantify the degree of tissue damage and brain reorganization after stroke.     Thirty patients will be included during the first 24 hours after stroke onset. Multimodal MRI     (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution     anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours,     at 3 months and at 12 months.   "
70019|NCT02369315|"     This study evaluates Venezuela's National System of Child and Youth Orchestras, better known     as El Sistema.   "
70020|NCT02369302|"     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug     interaction between DWC20141 and DWC20142 in healthy adult subjects.   "
70021|NCT02369289|"     A vegan diet is more and more prevalent in the general population in Israel in recent years.     There have been some concerens that a vegan diet may lack in bone-health related nutrients     (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral     density. The study aims to compare bome mineral density and other biochemical bone health     parameters in vegan and omnivore non-menopausal Israely females.   "
70022|NCT02369276|"     The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle.     2. The soft tissue injury may be related with the order of severity of wing scapula and     duration after SND. The aims of this study are: 1. To assess the functional disabilities of     shoulder and upper extremity in different time period after SND. 2. To evaluate the soft     tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This     study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC     post SND within 3months, >3- 6months,> 6months -1 year, more than 1 year as four different     groups, 20 patient in each group.   "
70023|NCT02369263|"     Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency     Department (ED) employing the two point compression method. This study endeavors to     investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in     the ED by EM Residents by comparing the results of that exam against the gold standard of a     DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.   "
70024|NCT02369250|"     Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic     statin, that stimulate bone formation in critical-size cortical bone defects adjacent to     titanium implants, when administered locally in bone. Platelet-rich fibrin (PRF) is a     platelet concentrate with sustained release of various growth factors, having regenerative     potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material has     clinically satisfactory response, when used to fill periodontal intrabony defects. This     double-masked randomized study is designed to evaluate the potency of combination of RSV     1.2mg in situ gel with 1:1 mixture of autologous PRF and HA bone graft in the surgical     treatment of mandibular degree II furcation defects when compared with autologous PRF and HA     bone graft placed after open flap debridement (OFD).   "
70025|NCT02369237|"     Anemia and inflammation are very common in patients with renal diseases. The most common     procedure to detect anemia is to determine blood hemoglobin concentrations. The Haemospect®     is a portable device for non-invasive hemoglobin determination that works with a sensor that     is applicable in infants and adults alike.      The objective of this trial is to collect spectra with the non-invasive Haemospect® device in     children of different age groups with renal failure and different hemoglobin concentrations.     In parallel, corresponding hemoglobin values shall be obtained invasively to form the basis     for the development of an algorithm for the device.      To determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are     measured non-invasively with the Haemospect®. Various blood parameters for iron and     inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron,     white blood cell count and CRP.   "
70026|NCT02369224|"     A Cross- Sectional study; To assess the intra-rater and inter-rater reliability of a     hand-held dynamometer (HHD) in the assessment of lower extremity strength in patients with     multiple sclerosis   "
70027|NCT02369211|"     To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its     potential to improve hospital efficiency and patient outcomes. The investigators compare the     addition of IV acetaminophen versus placebo on postoperative PACU recovery times, inpatient     hospital length of stay (LOS), patient satisfaction scores, postoperative pain scores,     consumption of opiates as rescue agents and side effects, and costs associated with     postoperative medications among patients undergoing robotic-assisted laparoscopic     prostatectomy (RALP).   "
70028|NCT02369198|"     The first testing of TargomiRs in the human setting: dose-finding studies in patients with     recurrent malignant pleural mesothelioma and non-small cell lung cancer   "
70029|NCT02369172|"     CYP2B6 is involved in the metabolism of many drugs. So, it is important to assess in vivo the     effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of this     trial is to investigate the potential for interaction of ASP2151 with the CYP2B6 probe     substrate bupropion.   "
70030|NCT02369159|"     This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of     IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of     pediatric subjects with acute uncomplicated influenza. Two thirds of the participants will     receive peramivir, while one third will receive oseltamivir.   "
70031|NCT02369146|"     The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of     two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected     adults with virological suppression.   "
70033|NCT02369120|"     Aim: The aim of this project is to identify chronic low back pain patients´ beliefs about the     origin and meaning of pain for developing a biopsychosocial web-based educational     intervention. The other aim of this project is to assess the effectiveness of this web-based     educational intervention for chronic low back pain patients on pain cognitions, pain     intensity, and disability.      Methods: Mixed methods design, combining both qualitative and quantitative methodologies. For     the qualitative part of this study, the investigators will use qualitative in-depth     semi-structured interviews. For the quantitative phase we will use an experimental study     design.      Subjects: Chronic low back pain patients between 18-65 years old, attending a primary care     setting in the city of Lleida.      Expected outcomes: The investigators expect to change and modify chronic low back pain     patients´ cognition by using our web-site educational intervention, with the further outcome     of reducing pain and disability.   "
70034|NCT02369107|"     Nausea and vomiting are the most common symptoms experienced by cancer patients after     chemotherapy. Some patients have to endure such unpleasant symptoms even after using of     antiemetic or anti-vomiting medications.The purpose of this study is to assess the     therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting on     patients with malignancy   "
70035|NCT02369094|"     Acupressure has been used for thousands of years in China. Through applying pressure on the     specific acupoints based on TCM theory, acupressure could promote relaxation and wellness,     balance yin-yang and treat diseases.      The PI has been using acupressure to treat various diseases in the clinics of the School of     Chinese Medicine, HKU. Acupressure has demonstrated significant efficacy in treating     geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid arthritis and various     painful symptoms. When applying acupressure on the Head- Neck - Shoulder area, it could also     help to improve insomnia, reduce pain, and regulate the mood of the patients.      Frailty is a geriatric syndrome of growing importance in the medical field. Prevalence of     frailty increases with age. As our life expectancy increase, there will be more elderly     suffered from frailty in the later stage of their life. Although there is still a lack of     universally accepted clinical definition for frailty, the syndrome is now commonly understood     as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty     could be initiated by single or multiple conditions including malnutrition, chronic diseases,     lack of exercise, stress and physiological or social changes caused by aging. Its     manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional neuroendocrine     system and a pro-inflammatory state. Frailty could affect the emotional state of the elderly,     meanwhile, positive affect is protective against the functional and physical decline     associated with frailty.[1] There is limited treatment or medication for frailty. The     investigators believe that acupressure could be a possible non invasive means to improve the     general health conditions, including the emotional conditions of the frail elderly. In the     past 2 years, the school of Chinese Medicine has been promoting acupressure as a health     maintenance technique to the elderly, mostly frail elderly living in the community dwelling     through seminars. It is in our interest to run a prospective research to further understand     the efficacy of acupressure in a wider range of frail elderly. The investigators would like     to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate if     acupressure could help the frail elderly to improve their general quality of life.   "
70036|NCT02369081|"     This study was recommended by NICE, as part of its 2006 guidance for the treatment of     hypertension, and is urgently required to provide evidence for the treatment recommendations     in patients with resistant hypertension. The study will be a randomised placebo-controlled     double-blind crossover comparison of an α-blocker (α), β-blocker (β), and K+-sparing diuretic     (∆).      Patients will have a BP at entry above target on ABPM or home monitoring despite supervised     administration of maximum tolerated doses of A+C+D. Over 48 weeks they will then receive, in     random order either placebo or two doses each of doxazosin (α), bisoprolol (β) or     spironolactone (∆). Each treatment cycle will last 12 weeks, with a forced dose-doubling at 6     weeks.      The time course for the study will be similar to study one. 340 patients will provide 90%     power, at α=0.01 to detect a 3 mmHg overall difference in home sBP between any one drug and     placebo, with spironolactone hypothesized to be best overall. The study will be able to     detect a 6 mmHg difference in sBP between each subject's best and second-best drug predicted     by tertile of plasma renin, justifying routine use of the measurement in patients with     resistant hypertension.   "
70037|NCT02369068|"     The goal of this study is to compare the effectiveness of two different medications used in     intravaginal trigger point injections (injections into extremely painful areas of a muscle)     to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared     from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic     corticosteroid used as an anti-inflammatory agent).   "
70038|NCT02369055|"     The aim of this study is to analyze and describe rehabilitation pathways of stroke patients     in northern Norway and Denmark in relation to how patients describe their health-related     quality of life one year post stroke.      The study will consist of 1) Translate, cross-cultural adapt and validate a questionnaire 2)     Describe the level of quality of life and rehabilitation pathway in the two countries 3)     In-depth interviews of a smaller group of patients for a more complex understanding      The study is part of a larger prospective observational multicenter-study of two patient     cohorts with stroke.   "
71210|NCT02353689|"     This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN)     formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed     patients through the randomized, double blind and placebo-controlled trial.   "
70039|NCT02369042|"     External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory     rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies     while tracking clinical changes in acute in-hospital and chronic outpatient heart failure     patients.   "
70040|NCT02369029|"     This is the first study where BAY1238097 is given to humans. Impact of the study is to     evaluate if patients with advanced cancer show clinical benefit under the treatment with     BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all     comers) and lymphoma will receive the study drug treatment in an escalation scheme (no     placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of     BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be     determined      After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung     cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be     enrolled A separate escalation scheme will be applied to patients with leucemias, and at the     maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled.      the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters     of BAY1238097 and tumor response to the treatment.      BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the     tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the     patient decides to withdraw from the treatment.   "
70041|NCT02369016|"     Assess the efficacy and safety of copanlisib monotherapy   "
70042|NCT02369003|"     This pilot study is designed to follow up on a previous, preliminary study and test the     long-term safety and feasibility of the implantation of autologous peripheral nerve grafts     into the substantia nigra pars compacta (SNpc) or the basal nucleus of Meynert (NBM) in the     basal forebrain of participants with PD undergoing deep brain stimulation (DBS) surgery.     Peripheral nerve tissue contains Schwann cells which produce growth factors that have been     demonstrated to support the survival and function of neurons.      Participants will serve as their own donor for the tissue, which will be implanted at the     time they undergo DBS surgery.   "
70043|NCT02368990|"     The aim of the study is to collect real world information on patients with locally advanced     or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment     with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have     been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin     /Carboplatin).   "
70044|NCT02368977|"     This study will evaluate the feasibility of using the Third Eye Panoramic device in     conjunction with standard colonoscopes in a clinical setting.      Patients will undergo a colonoscopy procedure during which the study device will provide     video imaging of areas of the colon that are difficult to evaluate with the colonoscope     alone.      The utility of the device will be assessed from the impressions of the investigators and from     telephone follow-up with subjects to assess for post-procedural complications.   "
70045|NCT02368964|"     In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the     end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing     hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually given     between 12-24 hours before the hCG triggering dose.One protocol used at the investigators     unit, after a cycle with low proportion of mature oocytes per number oocytes retrieved, is     triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration.      Lately, new researches showed that dual triggering of final oocyte maturation with a     combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders     undergoing the GnRH-antagonist COH protocol      Another treatment option is high dose hCG. Only few case reports have described the use of     high dose hCG after aspiration of non mature oocytes at a previous cycle. At the     investigators IVF unit, patients with previous history of high percentage of immature oocytes     retrieved, are triggered at the following cycle, either with double trigger or with high dose     of hCG decided by the physician consulting the patient. It is still not known with which way     of triggering more mature oocytes is retrieved.      The aim of this study is to perform a prospective randomized controlled study in patients     with low proportion of mature-MII oocytes oocytes (<75%) per number oocytes retrieved,     despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles     triggered with high dose hCG to those triggered with hCG+GnRH agonist.   "
70046|NCT02368951|"     To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and     pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with     advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)   "
70047|NCT02368938|"     The Northern Shanghai Study is a prospective community-based study, which is aimed to     investigate the prognostic factors, including conventional cardiovascular risk factors and     asymptomatic target organ damage, for mortality and cardiovascular diseases, in 5,000 elderly     Chinese.   "
70048|NCT02368925|"     Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to     improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale     score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up     visits.   "
70049|NCT02368912|"     This study consists of four parts:      Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in     healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and     effect on certain hormones and if possible to determine the highest well-tolerated dose of     ASP1707 in healthy young male subjects under fasted conditions.      Part 2 is an open label, randomized crossover, single dose study to determine the effect of     food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male     subjects.      Part 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to     evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly men     and healthy premenopausal females, and to determine the effect on certain hormones in males.     Age and gender is also evaluated.      Part 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to     evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in     healthy pre-menopausal female subjects.   "
71713|NCT02347085|"     Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study     to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD     after 4 Weeks of Treatment with PT003 and Placebo MDI   "
70050|NCT02368899|"     This project expands upon the proof-of-concept work done under the pilot project in order to     get Interventionaire© poised for more widespread use. Interventionaire© is designed to deploy     a computerized interactive questionnaire to patients in a physician waiting room. The     information gathered is intended to be a conversation starter for primary care providers and     patients (who may feel more at ease with the computer in revealing health risk behaviors,     like alcohol abuse). Widespread use of Interventionaire© could result in a substantial cost     savings by delivering a wide reaching and highly acceptable prevention strategy for     integrating risky health behavior screening and brief intervention into mainstream medical     practice.The investigators overall hypothesis is that participants receiving the computerized     intervention will have greater improvement than those receiving the attention control     condition.   "
70051|NCT02368886|"     This randomized phase II trial studies how well lower-dose compared to standard dose     regorafenib works in treating patients with colorectal cancer that has spread from the     primary site (place where it started) to other places in the body and does not respond to     treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new     blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell     growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective     in treating patients with colorectal cancer. Clobetasol propionate is a steroid cream that is     commonly used to treat a variety of skin conditions and may help prevent hand-foot skin     reactions in patients receiving regorafenib.   "
70875|NCT02358083|"     The purpose of this study was to determine whether messages about 1. relative risk of     vaccination vs. other activities and 2. strength of doctor's recommendation influenced     parental intention to get own child vaccinated against human papillomavirus (HPV) or     Influenza.   "
70052|NCT02368873|"     Study is a prospective, multicenter, randomized trial evaluating whether prophylactic     laparoscopic placement of a dual-component IPOM mesh around a colostomy may prevent     parastomal hernia compared with conventional colostomy after abdominoperineal resection.     Eligible subjects will be recruited prospectively from five Finnish Hospitals (Oulu     University Hospital,Vaasa Central Hospital, Helsinki University Hospital, Lahti Central     Hospital, Jyväskylä Central Hospital). Patients were considered eligible for this study if     undergoing laparoscopic abdominoperineal resection for rectal adenocarcinoma. Patients are     randomized to prophylactic preperitoneal placement of a dual-component mesh (Dynamesh IPOM)     around permanent colostomy or to conventional permanent colostomy. Estimating a parastomal     hernia rate of 50%, a sample size of 26 patients per each study group is projected to provide     90% power (1-beta) with a alpha 0.05 (2-beta) to detect a 40% reduction in risk for     parastomal hernia at 1-year. Since we expect a dropout rate of 20%, 37 patients per study     group will be included in this study.      All abdominoperineal resections are performed using laparosopic technique. At the and of the     abdominal laparoscopic phase the straight permanent end colostomy is performed. In the     intervention group the 10 x 10 cm Dynamesh IPOM mesh is cut in the middle according to volume     of the bowel. Stapled bowel end is then pulled through the crosswise opened mesh, which is     pushed to the abdomen and fixed to the peritoneum.      Follow-up visits are scheduled at 1-, 3- and 12-month after surgery. Patients are evaluated     for their clinical status and C-reactive protein, leukocytes and hemoglobin are assessed at     each control visit. Computed tomography (CT) scan with and without Valsalva maneuver is     performed 12 months after surgery for radiological evaluation of possible parastomal hernia.      The primary end-point of this study is the incidence of clinically and radiologically     detected parastomal hernias, and their extent 12 months after surgery. The secondary outcome     end-points were colostomy-related morbidity such as stomal stenosis, necrosis and/or wound     infection.The extent of parastomal hernia was graded at CT according to the Hernia Society     criteria.      Statistical analysis is performed using a SPSS statistical software. Continuous variables are     reported as the mean and standard deviation, whereas nominal variables are reported as counts     and proportions. Univariate analysis is performed with the Mann-Whitney U test and Fisher's     exact test. P-values < 0.05 are considered statistically significant.   "
70053|NCT02368860|"     This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI     regimen [oxaliplatin (O), xeloda (X) and irinotecan (I)] and to evaluate for preliminary     evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma.     The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype     directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda)     administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid,     fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.   "
70054|NCT02368847|"     Urinary tract infections are one of the most common types of infections in older persons. The     general aim of this study is to improve the epidemiological knowledge and develop a better     diagnostic algorithm for urinary tract infections in older institutionalized individuals in     order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.   "
70055|NCT02368834|"     This study designed and evaluated a psychoeducation program for parents of ADHD children in     terms of improving medication adherence and clinical benefits.   "
70056|NCT02368821|"     A deeper understanding of the syncytiotrophoblast development processes and its properties     may allow a better understanding of the placenta pathological process for the development of     treatment models for the relevant pregnancy complications.The aim of this study is to compare     telomere length, aggregate formation, and senescence markers in placentas from complicated     pregnancy with placentas from normal pregnancy.   "
70057|NCT02368808|"     Coping with Loss is a randomized controlled trial to assess the effectiveness of a     bereavement intervention targeting female adolescents who have experienced the death of     someone important in their lives. Adolescents aged 12 and older in the Free State province of     South Africa will be invited to participate in an 8-session school-based peer support group     focused on coping with loss. Interventions will be implemented by Social Workers from Child     Welfare Bloemfontein and Childline Free State (CWBFN & CLFS) that have provided support     services for orphans and vulnerable children (OVC) in the Free State Province since 2013. The     study population will be identified through the CWBFN & CLFS intake process and consist of     bereaved female adolescents from up to 11 participating schools. Eligible adolescents will be     randomly assigned to receive the intervention in 2015 or wait-listed for enrollment following     the study period. Survey data will be collected from adolescents and caregivers before and     two months following the completion of the interventions. Data will be analyzed to assess for     pre- and post-test differences between the intervention and wait-listed group on key     psychosocial outcomes, including measures of grief, resilience, mental health, social     support, academic competence and adolescent-caregiver interactions.   "
70138|NCT02367755|"     Therapeutic hypothermia has been proven to significantly improve the survival and     neurological prognoses in patients resuscitated from cardiac arrest. Propofol has been     reported to exhibit potentials in mitigating ischemia-reperfusion injury via the     antioxidative, anti-inflammatory and neuroprotective mechanisms. This study is to investigate     the potentials of propofol in further improving the survival and neurological prognoses in     this era of therapeutic hypothermia.   "
70058|NCT02368795|"     Pancreatitis is the most important complication of ERCP. The severity of this condition     varies from mild to severe and can lead to prolonged hospitalization, surgical interventions,     and even death. Several patient-related and procedure related factors have been identified     that are associated with a higher risk of post-ERCP pancreatitis. So far, several methods     have been proposed to avoid pancreatitis in patients at higher risk of this complication.      Several studies have shown that different drug therapies (indomethacin suppository, a     sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may     reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and     easy to administer.      Several other studies have shown that pancreatic duct stenting (placement of a plastic tube     in the pancreatic duct) is an effective intervention in preventing and reducing the severity     of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few     drawbacks to consider with pancreatic duct stenting: there are some difficulties with     insertion of a PD stent, it is associated with a need for radiological follow-up and/or     repeat endoscopy for removal, higher cost and a small but important risk of complications     (e.g. stent migration).      Most of the clinical trials of pancreatic duct stenting were performed, before the results of     trials of drug therapies were available. Moreover, no RCT (to the investigators knowledge)     has compared the efficacy of pancreatic duct stenting in patients who already received a     combination of drug therapies to prevent post-ERCP pancreatitis in high-risk patients. The     purpose of this study is to determine the noninferiority of a combination of drug therapies     in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in high-risk     patients.   "
70059|NCT02368782|"     Otoacoustic emissions (OAEs) are non-invasive, easy to apply and objective test methods which     are widely used to determine the presence of hearing in audiology clinics. Under some     circumstances and children, the study should be applied under general anaesthesia. The aim of     this study was to find out the influence of propofol (P) and ketamine (K) on OAE     measurements. .      Methods: Thirty- healthy children who will underwent adenoidectomy and tonsillectomy will be     included in this study after Institutional ethics committee approval and informed consent of     parents. Children will be evaluated one day before surgery by tympanometry. Psychologically     prepared children will be admitted to the operating room. Following EMLA (Eutectic Mixture of     Local Anesthetics ) cream application IV line will be inserted. ECG and non-invasive blood     pressure will be monitored. Transient evoked otoacoustic emissions (TEOAEs) and distortion     product otoacoustic emissions (DPOAEs) will measured in both ears of each patient (n=20 ears)     prior to P or K administration( Pre-P and Pre-K). Propofol will be given 2mg/kg or ketamine     2mg/kg intravenously and 40% O2 in air will be given by mask ventilation. Five minutes later     TEOAE and DPOAE measurements will be repeated (Post-P and Post-K). After this measurement the     routine general anaesthesia and surgical protocol will be commenced. Heart rate, blood     pressures TEOAE and DPOAE measurements will be compared at pre and post stages by paired     Student's t- test.   "
70065|NCT02368704|"     The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway     is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients     compared to healthy subjects normoglycemic matched for age and sex an to investigate whether     ER stress pathway can be activated in response to insulin. Indeed, some preliminar on rates     studies shows that ER stress pathway is activated by insulin in liver and adipose tissue     showing that hyperinsulinemia might help trigger stress path ER.      For this, we propose a case control study of type 2 diabetic patients vs control subjects in     which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue     obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue     subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.   "
70066|NCT02368691|"     The purpose of this study is to determine if GTx-024 is effective and safe in the treatment     of patients with advanced, androgen receptor positive triple negative breast cancer (AR+     TNBC).   "
70067|NCT02368678|"     The objective of this study was to evaluate whether short-term full mouth disinfection     protocol could have a greater reduction in the levels of halitosis and volatile sulfur     compound or not, when compared to quadrant-wise scaling and root planing   "
70068|NCT02368665|"     Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination     therapy on patients of essential hypertension who are not properly controlled by amlodipine     besylate monotherapy.   "
70069|NCT02368652|"     Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination     therapy on patients of essential hypertension who are not properly controlled by candesartan     cilexetil monotherapy.   "
70070|NCT02368639|"     This study will use a modified version of a positive airway pressure device to supply air to     the participant, while undergoing supervised polysomnography. Positive airway pressures are     typically applied to many patients with hypoventilation, in this study these pressures will     be titrated by a qualified sleep technician. During the night these pressures will be altered     to optimise comfort.   "
70071|NCT02368626|"     The need for cosmetic facial enhancement procedures with minimal down time and low risk has     led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers     were developed, which remove the full skin surface in a controlled manner. However, the     prolonged recovery and the significant risks prompted the development of fractional lasers     which ablate the skin in a fractional manner, leaving untreated areas to improve healing     process. In the past few years, fractional RF systems have been introduced that enable     controlled skin resurfacing accompanied with dermal collagen remodeling. System using focused     ultrasound , coagulating small volume of tissue in the dermis , have shown a lifting effect.8     Similar to these devices the EndyMed Pro™ System with RF Micro-Needles handpiece (INTENSIF)     enables fractional skin coagulation with dermal heating for the reduction of wrinkles     together with a lifting effect.   "
70072|NCT02368613|"     The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of     hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each     groups are composed by 16, will be participated in this trial.   "
70093|NCT02368340|"     Hermansky-Pudlak Syndrome (HPS) is a rare genetic disease that is associated with     oculocutaneous albinism, bleeding, granulomatous colitis, and pulmonary fibrosis in some     subtypes, including HPS-1, HPS-2, and HPS-4. Pulmonary fibrosis causes shortness of breath     and progressive decline in lung function. In HPS patients with at-risk subtypes, almost all     adults eventually develop fatal pulmonary fibrosis unless they undergo lung transplantation.      The purpose of this study is to identify the earliest measurable pulmonary disease activity     in individuals at-risk for HPS pulmonary fibrosis. The study also aims to develop biomarkers     that will aid in understanding of the causes of HPS pulmonary fibrosis and facilitate more     rapid conduct of therapeutic trials in HPS patients with mild pulmonary disease in the     future.   "
80047|NCT02238132|"     To obtain further information on the tolerability of Atrovent® inhalets in the treatment of     Chronic Obstructive Airways Disease under conditions of daily practice   "
70073|NCT02368600|"     The number of women with gestational diabetes mellitus (GDM) had been increasing. Maternal     GDM has a great impact on both the health of the mothers and the offspring. Antenatal     lifestyle interventions, in particular dietary intervention appear to be feasible to improve     maternal GDM and weight gain. To the best of our knowledge, there has been no such trial     examining the feasibility of a lifestyle intervention in pregnant women in Hong Kong.     Therefore, we plan to conduct a randomized controlled trial comparing a lifestyle     modification program (LMP) in early pregnancy and the usual antenatal care in high risk     Chinese pregnant women in Hong Kong. Intervention group subjects (n=110) will participate in     a dietitian-led LMP including dietary and exercise component from the first antenatal (AN)     booking to 24 weeks gestation. 110 women in the control group will receive routine hospital     antenatal care. The primary endpoint will be the prevalence of GDM measured using a 75 g oral     glucose tolerance test at 24-28 weeks gestation. The secondary endpoints will be the     proportion of infant born with large for gestational age (>=95th percentile of the customized     birth weight) and macrosomia (>=4 kg at birth). The intervention group involves dietary and     exercise advice and monitoring. No drug or invasive procedure is involved. The control group     will receive routine antenatal care and will be provided with an educational pamphlet on diet     and exercise during pregnancy.   "
70074|NCT02368587|"     The purpose of this study is to investigate the safety and efficacy of intracoronary or     intravenous infusion human umbilical Wharton's jelly-derived Mesenchymal Stem Cell (WJMSC) in     patients with ischemic cardiomyopathy secondary to myocardial infarction.   "
70075|NCT02368574|"     Based on the value-based medicine, a randomized clinical trial was conducted to compare the     role of class II and class III hysterectomy in patients with low risk early staged cervical     cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).   "
70076|NCT02368561|"     A pilot study of the effects of 3 retro-calcaneal hyalin G-F 20 injection on the clinical and     radiological changes in 20 adult patients with changes in insertional achilles tendinopathy.   "
70077|NCT02368548|"     The study aims to assess the clinical and economic impact of a pharmaceutical care program     initiated in the Emergency Department versus conventional follow-up of patients with     decompensated heart failure/COPD.   "
70078|NCT02368535|"     The investigators wanted to determine if the establishment of interdisciplinary rounds has     made meaningful changes in the perceptions of teamwork and communication.      The purpose of this study is to determine if the establishment of interdisciplinary daily     rounding has improved teamwork in an academic, tertiary care labor and delivery unit.   "
70079|NCT02368522|"     The study aims to collect information on the current treatment patterns for Hepatitis C in     participating countries. There is also a focus on patients receiving a daclatasvir-containing     treatment regimen who will be followed prospectively for 12 months after treatment initiation     to collect real-world data on effectiveness and safety of the treatment. Additional analysis     will differentiate between selected subpopulations.   "
70299|NCT02365623|"     The purpose of this study is to explore safety and efficacy of TMC207 administered as part of     a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary     multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207     and its primary metabolite M2.   "
70080|NCT02368509|"     The aim of the present study was to evaluate the impact of chemotherapy on sensorial     perception in lung cancer patients in comparison to a control group (individuals without lung     cancer and chemotherapy treatment). We will use a longitudinal approach whereby 44 patients     and 44 controls will be tested for olfactory and gustatory abilities before and after     treatment (for patients) and for two sessions separated by the same duration for controls.     Primary measure outcome will be to examine the impact of treatment on the perception of     hedonic valence of odors. Secondary measure outcome will include odor and taste perceptual     changes and questionnaires on eating habits and behaviors, in order to examine the impact of     treatment on odor, taste and food perception.   "
70081|NCT02368496|"     Recent progress in parenteral nutrition has contributed to improve vital prognosis and to     reduce morbidity in patients with severe intestinal failure.      Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for     those patients. However, long-term parenteral nutrition can result in complications     especially in bone, such as osteopenia or osteomalacia, then increasing the risk of     fractures. Children are especially at risk because of bone growth and peak mineralization     acquisition during puberty.      Moreover, frequency and risk factors of those complications are not well documented for     children.      Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone     mineralization measurement. In pediatrics, this technique has some limits such as the     underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD     in tall children, and the inability to distinguish cortical from trabecular bone or to     evaluate the bone microarchitecture.      HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive     assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA.     However this technique has never been validated in patients with long-term parenteral     nutrition.      During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in     addition to the routine medical tests.   "
70082|NCT02368483|"     This is a single-group, prospective, intervention study. A total of 30 participants with     unilateral symptomatic femoroacetabular impingement will be included into the study. The     intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2     times/week supervised training, 2 times/week home training). The training includes physical     exercises routinely used worldwide in clinical settings. No control intervention group was     included into the study because nowadays there is no standard conservative treatment for     patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1)     baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical,     functional, neuromuscular and self-reported parameters will be collected during assessments.   "
70094|NCT02368327|"     This clinical study is part of the BIOVACSAFE project which is funded by the Innovative     Medicine Initiative. In this study we will take a small muscle biopsy in order to identify     any differences in the response around the actual site of injection compared with responses     we measure in blood at the same time.   "
70083|NCT02368470|"     New generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a     broad-spectrum activity against Gram-positive and Gram-negative bacteria, and have been     successfully introduced into the treatment of Helicobacter pylori infection. However, it was     suggested that resistance to fluoroquinolones has been increasing in the Korean population     and the resistance is most likely mediated through point mutation in gyrA. Gemifloxacin     (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily,     oral dosing. In vitro studies have shown that gemifloxacin displays potent activity against     Gram-positive organisms, whilst retaining good activity against Gram-negative organisms.     Gemifloxacin is the most potent member of the quinolone class against S. pneumoniae with     activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times     greater than those of moxifloxacin. Importantly, gemifloxacin displays potent in vitro     activity against strains of S. pneumoniae with known resistance to β-lactams, macrolides and     other members of the quinolone class. This potent activity is believed to be due to the     enhanced affinity of gemifloxacin for topoisomerase IV, the major fluoroquinolone target in     S. pneumoniae. Furthermore, gemifloxacin displays potent activity against H. influenzae and     M. catarrhalis and atypical organisms such as L. pneumophila, C. pneumoniae and M.     pneumoniae. It has proven particularly effective in respiratory and urinary tract infection.   "
70084|NCT02368457|"     Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic     and irreversible complication after head and neck radiotherapy with no medical treatment to     limit or reduce symptoms.      Different clinical trials have shown a significant scientific evidence that the treatment     with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the     tissue fibrosis. This study proposes to use this drugs to determine if there is healing of     mandibular osteoradionecrosis and/or a symptomatic improvement as well.   "
70085|NCT02368444|"     The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral     therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms     and sleep quality in people who have experienced a traumatic event and are reporting trauma     symptoms.   "
70086|NCT02368431|"     This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication     zonisamide for the treatment of heavy drinking alcoholic Veterans.   "
70087|NCT02368418|"     China Rural Health Initiative (CRHI), a large-scale, factorial, cluster-randomized,     controlled trial was conducted in 120 villages selected from 5 Northern Provinces of rural     China between 2010 and 2012. Two interventions were evaluated through CRHI. One is the     standard disease management program of individuals at high risk of cardiovascular disease     delivered by Primary Care Providers (village doctors). Another one is a community-based Salt     Reduction program delivered by community health educators. CRHI study interventions had ended     for two years now and provide a good opportunity for us to understand whether its effects     could be prolonged to a longer term. This study wants to evaluate the effects of CRHI     interventions at 2 years after the end of CRHI (from Sep 2014 to Feb 2015).      In this follow-up survey, the baseline cohort of 5050 and post-intervention cohort of 4887     CRHI participants who were randomly selected from the 120 villages from 5 northern provinces     of rural China will be recruited for the follow up study from Sep 2014 to Feb 2015. A     questionnaire derived from CRHI baseline and post-intervention surveys will be used to     collect data on disease history, medication use, care seeking patterns, lifestyle factors and     so on. Weight, height, blood pressure and heart rate will be measured in the standard ways.   "
70300|NCT02365610|"     To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects     with inadequately controlled focal seizures.   "
70088|NCT02368405|"     This is a randomized controlled trial to study a nutrition education intervention in     individuals with spinal cord injuries both in the acute rehabilitation setting (n = 100) and     the community setting (n = 100). Participants in the treatment group will receive six     interactive nutrition lectures based upon a successful program that has been used in older     adults titled Eat Smart, Stay Well. The goals of intervention are to improve whole-grain,     fruit and vegetable, and low-fat dairy intake and reduce fat and saturated fat intake.     Secondary outcomes will include improvements in waist circumference of body mass index and     some biomarkers such as cholesterol and blood sugar.   "
70089|NCT02368392|"     The aim of this study is to describe incidence of in-hospital deaths and outcomes after     attempted cardiac arrest resuscitation, availability of resuscitation equipment and medical     staff training in state Hospitals of Sri Lanka.   "
70090|NCT02368379|"     The purpose of this study is to determine presence of central adrenal insufficiency in     children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to     results of overnight metyrapone test.   "
70091|NCT02368366|"     Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a     source of significant morbidity and family burden. Novel behavior problems are among the most     common and problematic consequences, yet many youth fail to receive needed psychological     services due to lack of identification and access. Linking youth with TBI to effective     treatments could improve functional outcomes, reduce family burden, and increase treatment     satisfaction. The investigators overarching aim is to compare the effectiveness, feasibility,     and acceptability of three formats of family problem solving therapy (F-PST) for improving     functional outcomes of complicated mild to severe adolescent TBI: therapist-guided,     face-to-face; therapist-guided online; and self-guided, online F-PST.   "
70092|NCT02368353|"     The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years     during which the psychotic symptoms are present at a subliminal level in severity or in     frequency. The clinical criteria mental status with risk (AR) identifies patients among     whom 10 in 40 % will make a psychotic transition in the year.      Our hypothesis is that interventions to reduce reactivity to stress are effective in reducing     the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms. Our     project is to evaluate a therapy for stress management in at risk patients, compared to a     conventional monitoring, and implement a longitudinal follow-up concerning the reduction of     psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these     interventions offer an alternative to antipsychotics all the more interesting since they     should also reduce the risk of depression and suicide.   "
80048|NCT02238119|"     Study to evaluate the lung function response to the free once-daily combination of tiotropium     + formoterol compared to formoterol BID and tiotropium QD   "
70097|NCT02368288|"     The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients     obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg     loss with sustained viral response after treatment. However this target could not be get if     patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw     of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA     load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine     therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of     combined therapy, compared with control group.   "
70098|NCT02368275|"     The objective of these cohorts is to detect potential genetic, neurophysiological     psychological and cognitive risk factors for the development of chronic postsurgical pain     including neuropathic pain.   "
70099|NCT02368262|"     This study evaluates (risk)factors influencing (in)continence in children with and without a     brain injury.   "
70100|NCT02368249|"     The investigators aim to address whether terlipressin improves the renal outcome after liver     surgery. Therefore the investigators are planning to conduct a double-blinded randomized     control trial. The investigators will randomize patients undergoing any kind of liver surgery     and being at increased moderate to high risk for post-operative acute renal failure into a     control group receiving post- operative a placebo or into a group receiving post-operatively     terlipressin in combination with human albumin.   "
70111|NCT02368106|"     This study will create a patient data registry to collect and analyze information on     technology usage and outcomes among patients receiving a broad range of relatively new     radiation treatments that have become standards of care in our practice. Review of this     information will serve as a basis for development of better patient management plans, to     inform decisions about acquisition of new technologies, to provide information about quality     in our care delivery, and to create a database that will securely warehouse ongoing     information about what treatments the patients we serve need most and the challenges they     face in the treatment process. The information gathered is likely to not only improve our     services at the University of Maryland and its community sites but to advance medical science     and enhance the quality of care for cancer patients.   "
70101|NCT02368236|"     This study will adapt and test a touch-screen computer program to evaluate cancer risk and     provide patient-tailored recommendations for appropriate risk-based testing. This     individually tailored intervention delivered right at the point of primary care and just     prior to the office visit, can be a helpful and non-obstructive adjunct to clinical care.      The primary aim of this project is to test whether a tailored intervention promoting     risk-appropriate cancer testing results increases participation compared with a simple     non-tailored reminder or no reminder. The trial is designed to determine the extent to which     the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate     colorectal cancer testing, as documented by electronic medical record audit; (2) patient     receipt of risk-appropriate colorectal cancer testing recommendations from their physicians,     as documented by electronic medical record audit; and (3) changes in patients' intent to     participate in risk-appropriate colorectal cancer testing, as documented by patient report.      The Family and Community Medicine and General Internal Medicine clinic databases will be used     to identify potentially eligible patients with upcoming scheduled appointments. Because     physicians will be the unit of random assignment, patients will be coded before study     invitation as potential participants in the intervention or the comparison group. A random     sample of eligible intervention and comparison group patients will be selected for contact.     Identified patients will be mailed letters from the practices and signed by their physicians     requesting their participation. The letters will describe a study of beliefs and practices     about cancer prevention and early detection and will provide a toll-free number to refuse     contact. One week after the mailing, patients who have not called to refuse contact will be     called by study staff to explain the study, verify eligibility and, if the patient agrees, to     arrange an in-person meeting at the clinic 30 minutes prior to their appointment. These calls     will be made by trained research assistants who will follow standard calling protocols. After     consent, participants will complete the computerized data collection (CRIS) immediately prior     to a scheduled primary-care appointment. Intervention group patients and their physicians     will receive a printout recommending risk-appropriate colorectal testing and ways to overcome     perceived barriers to testing. A member of the research team will hand the patient his or her     printout and will deliver the other printout to the physician. Comparison group patients and     physicians will receive non-tailored printouts that are simple reminders about testing.      The investigators will also establish a true no-contact control by conducting a retrospective     chart review for randomly selected patients who did not receive an invitation to participate     in the study. This no-contact control will establish a baseline screening rate. The     investigators will then conduct analysis with the comparison and intervention group to see if     individuals who participate in CRIS have a higher screening rate for colorectal cancer     compared to the non-contact group. These additional data will help us better assess study     Aims 1 and 2.   "
70102|NCT02368223|"     The aim of the study is to determine the feasibility of the portable version of the     YouGrabber® system in children with central motor disorders.   "
70103|NCT02368210|"     This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and     safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with     plaque psoriasis.   "
70104|NCT02368197|"     This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (DEB)     versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of     hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in     hemodialysis patients.   "
70105|NCT02368184|"     The purpose of this study is to obtain observational data allowing for the preliminary     assessment of the utility of a noninvasive physiologic monitor for monitoring of patients     with congestive heart failure.   "
70106|NCT02368171|"     Research design: This is a controled prospective study.      Methodology:      Patients with newly diagnosed and untreated OSA with total apnea-hypopnea index (AHI) >5/h,     and control (AHI<5/h) will be recruited from the Long Beach VA sleep center. Controls are     subjects without OSA or other sleep disorders and no sign of pulmonary hypertension based on     echo. The investigators also measure pulmonary artery pressure by 2D Echo and exclude patient     with any sign of left heart dysfunction. PH will be defined as RVSP > 35 mmHg or mean PA     pressure>25 mmHg. The investigators will recruit subjects with and without PH and OSA in     three separate groups:        1. group one : OSA+ PH,        2. group two: normal individual with no OSA and no PH,        3. group three: OSA with no PH Pulmonary function test will be done to exclude patients          with underlying lung disease.      The inclusion criteria is: Age >20, AHI >5, AHI <5 (as control), RVSP > 35 mmHg OR Mean PA     pressure>25 mmHg, RVSP < 35 mmHg OR Mean PA pressure < 25 mmHg (as control).      Subjects will be excluded if they had known peripheral vascular disease, liver disease,     hemolytic anemia, inflammatory disease, active infection, or if they were pregnant, on     therapy for OSA, on chronic steroid treatment, or younger than 20 years of age, patients with     left heart failure (systolic or diastolic), patients are on PH medications including     sildenafil, active smokers, COPD and asthma, active infection or inflammatory disease and     collagen vascular disease.      Nocturnal polysomnography will be performed and scored according to the American Academy of     Sleep Medicine.      Exhaled Carbon monoxide (CO) will be measured with a calibrated fuel cell type     electrochemical device with sensor sensitivity of 1 ppm. The mean of three reproducible     measurements will be recorded and corrected for ambient CO.      Exhaled Nitric Oxide (NO) will be measured. At each testing session, at least three     flow-regulated FENO measurements will be performed.      The investigators will repeat 2D Echo and measurements of above factors after 3 months of     CPAP treatment. The investigators also check patient's compliance with the treatment by     downloading data off of their CPAP device.      Each subject will be informed of the experimental procedures, which is approved by the Human     Investigation Committee of the VA-Long Beach.      Finding:      The investigators hypothesize that HO pathway causing perturbation of pulmonary endothelial     function by inhibition of nitric oxide.      Clinical significance:      OSA is associated with PH, but exact mechanism is not well known. In the past, I have shown     that increased endogenous CO in the setting of elevated NO concentration is associated with     endothelial dysfunction in patient with OSA. Therefore, the investigators sought to     investigate the roles of HO and NO pathways in patients with OSA associated with PH.      Impact/significance:      It addresses a fundamental gap in our understanding of how OSA results in increase the     pulmonary artery pressure and if substantiated, will provide the basis for the design and     testing of new approaches to prevention and treatment of OSA.   "
70107|NCT02368158|"     In this study predictors of fitness to drive a car in cardiologic patients after acute     intervention and discharge from hospital to home or rehabilitation are determined in addition     to possible automotive monitoring of vital signs via contact less sensors.   "
70108|NCT02368145|"     This study is being done to see if there is a relationship between stroke, post-stroke     depression, and measures of inflammatory and/or stress compounds in the blood. Brain injury,     as caused by stroke, leads to an inflammatory response in the brain which in turn can     influence inflammatory and stress responses in other parts of the body outside of the brain.     These responses can be measured by analyzing various substances in the blood and in the white     blood cells. The investigators will measure these substances (cytokines, glucocorticoids) and     compare them to the absence, presence, or degree of depression that the investigators will     determine by neurological and psychological testing. The investigators will be drawing blood     for this study on admission, at or around day 3, at or around day 7 and at or around day 90,     which is not part of routine stroke care. The investigators will be asking subjects to     participate in answering question/scales on these same days, some of these questionnaires are     also not part of routine stroke care. Standard stroke care is being done other than blood     drawing/participating in answering questions/scales. Approximately 25 people will be enrolled     over one year.   "
70422|NCT02364050|"     Prospective data collection of a consecutive series of elderly patients with large B-cell     lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric     Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of     Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G).   "
70109|NCT02368132|"     The proposed study seeks to compare usual care and two different interventions for caregivers     (CGs) of Veterans with dementia that are brief and administered by telephone. In the first     intervention, care management (i.e., assistance from a nurse or social worker who works with     the CG and Veteran's primary care providers), support, psychoeducation, and skills training     are tailored to each individual CG and delivered on an individual basis. In the second     intervention, care management is tailored and delivered to each individual CG, but support,     psychoeducation, and skills training are delivered (also by phone) in a group format. This     study will allow us to examine the added benefit of participating in a CG group that provides     mutual peer support and feedback. The investigators also will evaluate the extent to which     spousal vs. adult child CGs respond differently to the two interventions. Findings will help     refine patient/CG-centered care management and support programs designed to facilitate access     to services and improve the quality of life of Veterans with dementia and their families.   "
70110|NCT02368119|"     Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the     largest ever. Researchers want to develop a vaccine to prevent Ebola infection.      This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate     vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers,     age 18-65 years (mostly health care workers and other front line workers [e.g., individuals     who incinerate contaminated materials]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x     10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine.      Heterologous booster dose allocation - Each participant will be offered the opportunity to be     included in the booster step of this study. After obtaining consent and the additional review     of pertinent medical history, participants in each group will be randomized to receive the     candidate booster vaccine, MVA-EbolaZ or placebo.      This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the     first where the dosage level contains > 10(11) vp. It follows completion of a Phase Ib trial     in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z     vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity of     the bivalent vaccine will be compared to clinical and immunologic responses documented in in     parallel studies in East African subjects (Uganda) and North American subjects (NIH,     Bethesda, MD, USA).      Objectives:        -  To see if an Ebola vaccine is safe and to study immune responses to it.        -  To study the effect of the MVA-EbolaZ booster on the immune response      Eligibility:      - Healthy adults ages 18-65.   "
70116|NCT02368041|"     This is a single-center, non-randomized study.The study staff will use the InSpectraTM tissue     oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure baseline     StO2 levels after applying the noninvasive probe to the thenar eminence. After a stable     reading is obtained, a blood pressure cuff will be inflated 40 mmHg above the obtained     systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3     minutes or once the StO2 level comes to zero (whichever is earlier), the cuff pressure will     be released and the rate of reperfusion (Rres; % × sec-1) will be measured. The investigators     hypothesize that heart failure in children causes a baseline lower thenar tissue oxygen     saturation (StO2), a faster rate of desaturation (Rdes) and a prolonged rate of reperfusion     (Rres). The investigators also hypothesize that these changes will correlate with the     severity of heart failure. The results of this study will provide groundwork for studies     looking at correlation of therapy modification based on the combination thenar StO2 and     clinical presentation.   "
70117|NCT02368028|"     The fact that dental caries remains a major public health problem mandates that oral-health     researchers explore new strategies for assessment of caries risk, as well as for caries     prevention and management. Dental caries occurs when acids produced by bacterial glycolysis     of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries     research has been on identifying and characterizing acid-generating bacteria and the     mechanisms of acid resistance. The purpose of this study is to investigate the type of     bacteria that grows in the mouth and on teeth.   "
70118|NCT02368015|"     Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually     asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea.     Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate     symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection, or     following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease     requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive     therapies. Evidence that antibiotics are able to reach adequate intracystic concentration is     however lacking. To prevent procedure-related cyst infection in patients receiving aspiration     sclerotherapy, cefazolin prophylaxis is given as standard of care. In this study we want to     assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid     concentrations of cefazolin. We hypothesize that cefazolin is able to penetrate hepatic     cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of     developing cyst infection following aspiration sclerotherapy.   "
70119|NCT02368002|"     The purpose of this study is to learn how to personalize weight loss programs. In this     research we will study:        1. Whether a weight loss counselor should decide if the traditional weight loss therapy is          working either after 3 or 7 weekly sessions of therapy and        2. For those who haven't lost the expected amount of weight, whether it is more effective          to add packaged meals to the traditional weight loss therapy or to change to an enhanced          version of behavioral weight loss therapy.   "
70139|NCT02367742|"     It has been demonstrated the essential role of physical activity in the prevention of     overweight and obesity. Nevertheless, the effect of a program of physical activity on the     maintenance of body weight in subjects who have previously followed a dietary intervention is     still unknown. The aim of this study was to investigate this topic by evaluating the effect     of two different programs of physical activity on subjects who have followed a dietary     intervention but presented again NAFLD a year after the treatment.   "
70140|NCT02367729|"     This study evaluates the effectiveness of a neurostimulator applied to the outer ear for     adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve     stimulation to a branch of the vagus nerve which is thought to be involved in transmission of     pain signals. Half of the study subjects will receive an active nerve stimulator while the     other half will receive an inactive one.   "
70120|NCT02367989|"     Lifestyle modifications that include a diet high in fibre may lower the risk of developing     type 2 diabetes (CDA, 2013). In this context, the presence of soluble dietary fibre in     carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose     response (PPGR). Among these, oat and barley derived β-glucan have received tremendous     attention for their biological effects, including their ability to reduce PPGR in a wide     variety of food matrices (Poppitt et al, 2007). A health claim for PPGR would increase market     demand for food grade barley, and help those who want to limit the rise in blood sugar after     a meal choose products to meet their goals, but there are several gaps in the literature that     need to be filled before a submission to Health Canada can be successful: 1) test foods in     appropriate serving sizes; 2) test both the glucose and insulin response; 3) include a     reference product that matches in total fibre, macronutrient, and energy profile; 4) perform     dose response. The proposed study design will address all of these gaps in the current     literature and take into consideration Health Canada's guidance document for health claims     related to the reduction in PPGR, which sets out the criteria by which the validity of such     claims will be assessed.      Hypothesis:      Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner.      Specific objectives:        1. To determine the minimum and most effective dose of barley β-glucan in quick bread on          PPGR and insulin response in a cross-over, randomized, controlled clinical trial.        2. To assess the effect of barley β-glucan in a quick bread on appetite-related sensations          using visual analog scales.        3. To demonstrate whether the test and reference products were liked or disliked similarly          by participants.        4. To assess any gastrointestinal side effects from eating the test products   "
70121|NCT02367976|"     The purpose of the study is to evaluate the efficacy and safety of rh-prouk as     pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed     as a multicenter, active controlled, single blinded study. The primary endpoint is to assess     the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to     evaluate the mortality rate at day 30.   "
70122|NCT02367963|"     Cardiovascular disease is the leading cause of death in Spain and worldwide. Interventions     targeting dietary patterns, weight reduction and new physical activity habits often result in     impressive rates of initial behavior changes, but frequently these are not translated into     long term maintenance. We hypothesize that a peer-group intervention, addressing multiple     facets of cardiovascular disease risk factor can be successfully implemented improving the     adherence of participants to healthy habits.      A multicenter, randomized control trial scheme was adopted. A peer-group based intervention     approach in which community members support each other to promote health-enhancing changes     was chosen. Around 600 participants from 7 Spanish municipalities received a 12h initial     training and were randomly allocated to intervention or control groups for a 12-month peer     intervention. Baseline measurements took place before and after the initial training.     Follow-up measurements will be taken at the end of the intervention and 1 and 2 years after     the end of the study. The primary outcome is the improvement in a newly defined score     combining 5 individual variables. Secondary outcomes are 1, 2 and 3 years variations in     anthropometric parameters and/or healthy behaviors.      The project seeks the empowerment of subjects from 25 to 50 years of age to improve their     overall health habits and self-control of risk factor through peer education. The initiative     is being developed in cooperation with the Spanish Agency for Consumer Affairs, Food Safety     and Nutrition (AECOSAN). This study will allow the economic and feasibility evaluation of the     intervention, which will enable policy makers to consider its potential wider implementation     for a real community-based intervention.   "
70123|NCT02367950|"     The purpose of the study is to evaluate the feasibility of introducing an exercise programme     for endometrial cancer survivors.   "
70131|NCT02367846|"     This preclinical randomized crossover study will examine the effects of oral versus non-oral     contraceptive therapy on bone turnover in young exercising women. In an effort to expose the     route-dependent effects of oral versus non-oral contraceptive therapy on bone turnover, the     investigators will examine 1) the effects of ethinyl estradiol on bone calcium balance using     the 41Ca technology and 2) the underlying physiological mechanisms associated with the     effects of oral versus non-oral contraceptive therapy on net bone calcium balance.   "
70132|NCT02367833|"     This study will determine whether the negative effects of combined oral contraceptive (COC)     therapy on the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis and bone turnover     are dependent on the route of administration such that an attenuation of these effects is     observed when a comparable dose of non-oral transdermal contraceptive (TDC) and contraceptive     vaginal ring therapy (CVR) are also tested.   "
70133|NCT02367820|"     The purpose of this 52-week open label study is to determine the safety of a new opioid     molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic     non-cancer pain.   "
70134|NCT02367807|"     This is a 48-week prospective observational study that will allow testing of the hypothesis     that a program in which pre-exposure prophylaxis (PrEP) is administered to young men of color     who have sex with men (yMSMc) in a community youth drop-in center in conjunction with a     multifaceted behavioral intervention as well as standard HIV prevention interventions can     achieve at least 70% retention, as well as a medication adherence rate significantly better     than that previously reported in the literature. The proposed program evaluation can provide     critical information for the enhancement and scale-up of successful PrEP programs at FIGHT     and elsewhere in an effort to make PrEP available to a growing number of persons at risk of     acquiring human immunodeficiency virus (HIV).   "
70135|NCT02367794|"     This randomized, open-label study will evaluate the safety and efficacy of atezolizumab     (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel     compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants     with Stage IV squamous NSCLC.   "
70136|NCT02367781|"     This randomized Phase III, multicenter, open-label study is designed to evaluate the safety     and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with     treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV     non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab +     Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).   "
70137|NCT02367768|"     The investigators were looking for resuscitation management, trauma mechanism, risk factors,     and de novo biomarkers related to prognosis and long-term outcome for evaluating trauma     patients besides injury severity score (ISS) guiding the traumatologist. The medicare     resource could be utilized efficiently along with increasing in the survival and quality of     lifer (QoL) in major trauma.   "
70444|NCT02363751|"     Open-label, non-randomized, multicenter, phase II, single arm non comparative trial     evaluating toxicity and efficacy of gemcitabine plus platinium salt in combination with     bevacizumab in first-line setting in metastatic collecting duct carcinoma.   "
70141|NCT02367716|"     The purpose of this clinical study is to observe the safety and efficacy of the multi-vector     LV lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).      This is a multi-center, non-randomized observational study.      The total duration of the study is expected to be 2.5 years. The clinical study will be     conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in     this study. Subjects will be followed up at 3, 6, 12months and every 6 months afterwards. All     subjects need to be followed for at least 6 months.   "
70142|NCT02367703|"     Hysterectomy for benign uterine disease is often intended to young perimenopausal patients.     Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if     decreasing the diameter of laparoscopic instruments could reduce postoperative pain and     improve esthetic result without increasing operative time. The purpose of the study is to     improve patients' care.   "
70143|NCT02367690|"     Patients with eligible diabetic foot ulcers will be screened, treated, and followed for     complete ulcer closure. This is a randomized trial. All patients will receive     standard-of-care treatment. Additionally, some patients will receive treatment with topical     Selinexor gel and some will receive topical placebo gel.   "
70144|NCT02367677|"     To compare measurements made by a computer software (ImageJ) made on photographs to the     traditional clinical measures with a ruler in the evaluation of blepharoptosis   "
70152|NCT02367560|"     Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office.     The chronic and variable course of the condition can lead to dissatisfaction with     conservative management. Current standard of care at the Thunder Bay Regional Health Sciences     Centre is referral for treatment by either needle decompression therapy by a radiologist or     shockwave therapy by a physiotherapist. The purpose of this study is to compare the     efficacies of these treatment options.   "
70301|NCT02365597|"     The purpose of this study is to evaluate the objective response rate (complete response [CR]+     partial response [PR]) of the selected dose regimen in participants with metastatic or     surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.   "
70145|NCT02367664|"     Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of     the disease range from subtle changes in behavior to serious problems, including blindness,     ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs     primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex     tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is     from June to August and it mainly occurred in children. JE has ranked in top ten infectious     diseases according to either incidence or mortality. JE vaccines are used to protect the     population especially young children and infants from encephalitis diseases. Live attenuated     JE vaccines are now widely used. They are directly produced from attenuated virus which may     increase the possibility of virulence reversion. Many developed countries are using purified     model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new     generation of safer and more effective inactivated vaccine to prevent and control epidemic     encephalitis.   "
70146|NCT02367651|"     Pazopanib monotherapy is approved by the Food and Drug Administration (FDA), European     Medicines Agency, and other regulatory authorities worldwide for the treatment of patients     with advanced renal cell carcinoma and patients with advanced soft tissue sarcoma (STS) who     received prior chemotherapy. Based on the improved progression-free survival and sustained     responses observed in a pivotal Phase 3, randomized, placebo-controlled study, it is     hypothesized that pazopanib may have a role in a maintenance setting for STS in maintaining     the initial response to chemotherapy and delaying the need for further treatment at relapse     and its associated toxicity and impact on health-related quality-of-life. This Phase 2,     randomized, double-blind, placebo-controlled study will evaluate maintenance therapy with     pazopanib versus placebo in subjects with advanced or metastatic STS who have not progressed     after 4 to 6 cycles of first-line anthracycline-based chemotherapy. Approximately 188     eligible subjects will be randomized in a 1:1 ratio to treatment with pazopanib 800     milligrams (mg) daily or placebo. Study completion will be the point at which 70% of     randomized subjects have died. Once a subject has objective evidence of disease progression,     the subject will be managed as per standard practice by their physician. Subjects will     continue to be followed for second progression, health related quality of life, survival     until study completion, withdrawal of consent, or early termination of the study.   "
70147|NCT02367638|"     The purpose of this study is to determine whether varicella live vaccine is safe and     effective in the healthy adults.   "
70148|NCT02367625|"     Globally, cervical cancer is the second most common cancer for women and kills approximately     250,000 women every year, with the annual number of deaths expected to increase to 410,000 by     2030. The majority (88%) of these deaths occur in low- and middle-income countries (LMICs)     where screening and prevention services are limited. Prevention of cervical cancer by     identification and treatment of cervical cancer precursors is key, since treatment resources     for invasive disease are scarce. A cervical cancer screening program cannot be effective     unless it is linked with a proven intervention to prevent the development of cervical cancer.     The World Health Organization (WHO) recently released the WHO guidelines for screening and     treatment of precancerous lesions for cervical cancer prevention, which recommends a     screen-and-treat approach for cervical cancer prevention, with cryotherapy being the first     choice of treatment for women who have a positive screen. However, these programs are still     slow to be implemented in part due to the current high cost and low efficiency of cryotherapy     equipment that is often prone to breaking. Jhpiego, an affiliate of Johns Hopkins University,     has developed a new cryotherapy device, CryoPop, that is one tenth the cost of current     equipment while also ten times more efficient. Once proven safe, feasible and effective,     CryoPop could save tens of thousands of lives in low- and middle-income countries each year     by preventing cervical cancer.   "
70218|NCT02366689|"     The objective of this clinical research study is to assess the efficacy of a commercially     available triclosan/copolymer toothpaste compared to a commercially available oral hygiene     multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing     stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium     chloride relative to a negative control regimen in reducing established dental plaque and     gingivitis over three and six months of assigned product use.   "
70149|NCT02367612|"     Respiratory and gastrointestinal infections are common in children under the age of 4 years,     especially after the start of schooling. These conditions are facilitated by a still     incomplete functional maturation of the immune system and the anatomical structure and     function of the respiratory and gastrointestinal tract still developing. The frequency and     duration of these conditions involves a high discomfort and significant costs, in relation to     medical appointments, taking medication, the need for hospitalization, days of absence from     school and work days lost by parents. Functional foods derived from the fermentation of cow's     milk with probiotic strains have been proposed for the prevention of infectious diseases in     children. Several products have been investigated, with sometimes conflicting results.     Diversity in experimental designs, populations evaluated, and bacterial strains used in the     preparation of fermented products are probably responsible for these discrepancies. Recently     we started a study approved by the Ethics Committee for Biomedical Activities Carlo Romano     of the University of Naples Federico II (protocol number 210/12) to evaluate the     effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of     common winter infections in school children aged between 12 and 48 months. Studies of     pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain     Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine     IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella     typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo     intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental     colitis. A preliminary analysis of the data was found that subjects treated with fermented     milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract     infections or gastrointestinal, with a statistically significant difference between the study     groups. It was also observed a significant increase in the levels of α- and β- defensins,     LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to     subjects treated with fermented rice or placebo.      Therefore, we decided to extend the period of study of five additional months, in order to     perform an evaluation of the effectiveness of fermented milk (which was more effective)vs     placebo.   "
70150|NCT02367599|"     CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs.     standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection     (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control     substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In     CCTG 595, plasma from participants are being collected and stored at entry and every 12     weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in     both cases and controls at entry, week 24, and week 48.   "
70151|NCT02367573|"     Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only     two-dimensional view, which is somewhat challenging when operating in three-dimensional     environment. The three-dimensional laparoscopic systems are gradually entering the operating     rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions.     However, no prospective randomized trials have been published in the clinical point of view.     Therefore, the purpose of this study is to investigate is there something to gain in changing     into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia     repair.   "
70153|NCT02367547|"     This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and     aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic     therapy of superficially growing basal cell carcinomas. Study is conducted using randomised     prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary     Unit) with standardised set-up before and after the exposure. Efficacy is assessed     clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5     years.   "
70154|NCT02367534|"     Islet transplantation is one of the effective and promising options for type 1 diabetes     mellitus treatment1-4. The liver is the primary target location for infusion and portal vein     catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic,     laparoscopically transmesenteric and laparoscopically transumbilical approaches were often     utilized to access the portal. Current islet infusion approach via portal vein of liver has     various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage     and portal thrombosis. The laparoscopic entry techniques require longer surgical duration and     have an increased rate of catheterization failure. Moreover, the catheters were not allowed     to indwell for subsequent infusions.      In the current study, the investigators aim to performed open surgery, catheterized the     umbilical vein and infused islets into the portal vein. The catheter was indwelled for one     month after surgery. Therapeutic effects, surgical parameters and complications were observed     to evaluate feasibility and safety.   "
70155|NCT02367521|"     Traumatic brain injury (TBI) is frequently complicated by depression and other problems such     as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and     behavioral problems. Untreated depression can lead to reduced productivity and poor global     outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of     TBI-related depression. The overarching goal of this small study is to determine the     effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and     co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a     brain stimulation technique. It involves generating a brief magnetic field in a coil that is     placed on the scalp. The magnetic field passes through the skull and induces a weak     electrical current in the brain that briefly activates neural circuits at the stimulation     site. Adults aged 18 and older, with a history of head injury of mild or moderate severity ,     who are currently experiencing symptoms of clinical depression may join the study.   "
70156|NCT02367508|"     The study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness     meditation-based intervention designed to provide a synergistic solution to the avoidant     coping that often inhibits advance care planning discussions that are crucial to quality     end-of-life care.   "
70157|NCT02367495|"     Hypothesis:      Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with     citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with     iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of     limus-analogue drug-eluting stents (DES)   "
70167|NCT02367365|"     Neovascular Age-Related Macular Degeneration (NV AMD) remains the leading cause of vision     loss among people over 65. Intravitreal injections with drugs that block VEGF have     revolutionized treatment of NV AMD. However, less than 40% of treated patients have     clinically significant imporovement in vision. In this study, we will determine the relative     frequency of neovascular subtypes in two groups: 1) a representative, treatment-naive NV AMD     patient population, and 2) a population of patients who develop recurrent NV AMD activity     while off treatment and assess the frequency of persistent disease activity (PDA) according     to specific neovascular morphologic subtypes. This information will clarify the scope of the     PDA problem and will identify patients with PDA who may benefit from additional therpeutic     strategies.   "
70158|NCT02367482|"     In this research study, we will track the build-up of tryptophan, a radioactive tracer, in     the brain using positron emission tomography (PET) scanning. Tryptophan, in its natural     state, is an amino acid (one of the building blocks of proteins) that is normally present in     the brain, and is used by the brain cells to create various other compounds. This process is     altered in the presence of a brain tumor. By using a form of tryptophan marked with a small     amount of radiation, we will be able to track this process during the course of the PET scan.     This research will help determine if AMT PET is a useful method to recognize and     differentiate between various types of brain tumors. In addition, to study the mechanisms of     altered tryptophan uptake in the tumor and brain, we will also measure tryptophan levels and     related molecules in your blood (obtained as a part of the PET procedure) and tumor tissue     (in case you will have surgery to remove the tumor). This will help us to find new approaches     to treat brain tumors in the future by altering abnormal tryptophan metabolism.   "
70159|NCT02367469|"     The main purpose of this study is to determine the potential clinical utility of PET imaging     using the radiotracer [C-11]alpha-methyl-L-tryptophan in the diagnosis, differentiation and     monitoring of various brain tumors, both before and after initial treatment. We will also     study mechanisms and clinical significance of abnormal brain tumor tryptophan metabolism     using resected tumor tissues.   "
70160|NCT02367456|"     This multi center randomized (1:1), double blind, placebo controlled Phase 1b/2 study is     designed to compare the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of     PF 04449913 or placebo when combined with azacitidine in patients with previously untreated     Intermediate 2 or High Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) with     20-30% blasts and multi lineage dysplasia, and Chronic Myelomonocytic Leukemia (CMML). This     clinical study includes two components: (a) a Phase 1b safety lead in and (b) a randomized     Phase 2.   "
70161|NCT02367443|"     This is a phase I/II trial on concomitant RT-full dose CHT using accelerated     hypofractionation schedule as currently being in routine use in Poland for sequential     combination or RT alone. Objectives of the study are: to estimate rate of grade ≥ 3 CTCAE     adverse effects related to treatment and to estimate tumor control, progression     free-survival, and overall survival in patients treated with this regimen. Stage III NSCLC     patients are treated according to the following schedule: RT: 58.8 Gy in 21 fractions (2.8     Gy/fraction, 5 times a week, 6 times in the third week; CHT concomitant with RT (2 cycle of     Cisplatinum and Vinorelbine, every 21 days). Feasibility of the studied approach is evaluated     by scoring the toxicity during RT-CHT and therafter, as well as percentage of treatment     completion; efficacity is evaluated by estimation of local control and survival. If toxicity     and efficacity are similar or better than those observed in modern series of conventionally     fractionated RT-CHT, the studied regimen will become a routine treatment schedule in our     institution in order to spare RT resources. In the future, a randomized comparison of the     studied schedule with conventionally fractionated RT-CHT for locally advanced NSCLC is also     planned.   "
70198|NCT02366949|"     Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2     dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using     an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced     malignancies.   "
70162|NCT02367430|"     The purpose of this study is to investigate whether a well-established case management model     called Critical Time Intervention (CTI) can help individuals with hoarding disorder who are     concerned about the risk of eviction. Each individual with hoarding disorder will be assigned     to work with a CTI Specialist for 9 months, who will provide referrals for mental health     treatment, legal consultations, and registration for entitlements. All participants will be     offered a facilitated group intervention called the Buried in Treasures Workshop. The CTI     Specialist will also facilitate reconnecting the individual with supportive family/friends     and will monitor and support the de-cluttering of the patient's home.      A second comparison group will be offered the same group intervention (Buried in Treasures     Workshop) without the other parts of the CTI protocol.   "
70163|NCT02367417|"     The objective of this study is to collect outcome information on patients requiring Total     Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK®     Endo-Model® SL® under routine conditions.   "
70164|NCT02367404|"     Objectives:      Primary: Comparison of proportion of patient achieving continence between the four arms at 6     months.      Secondary:        -  Comparison of time to achieve continence between the four arms.        -  Comparison of urinary symptoms and quality of life improvement between the four arms.        -  Assessment of adverse events in Duloxetine arms.      Primary outcome/ time frame: Proportion of patient achieving continence at 6 months.     Continence is defined as using no pador only security pad.      Secondary outcome:        -  time to achieve continence        -  Quality of life tested in relation to incontinence according to Visual Analog Scale          (VAS) and King's Health Questionnaire (KQH).        -  Urinary symptoms measured with International Prostate Symptom Score (IPSS).      No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.      Statistical methods        -  Proportion of patients who achieve continence and time to achieve continence will be          compared between the four arms.        -  Comparison of quality of life outcomes between the four arms        -  Comparison of clinical variables that can affect the primary/secondary outcome -          univariate and multivariate analysis (ITT).   "
70165|NCT02367391|"     This study is evaluating the feasibility and short term smoking cessation outcomes of an     automated smoking cessation intervention delivered via mobile phone text messaging as an     adjunct to Varenicline in a primary care setting.   "
70166|NCT02367378|"     The purpose of this study is to collect information on the effect of minimally invasive spine     tumor decompression on treated patients. This treatment option is less invasive that the     standard surgical decompression and is expected to result in better wound healing, decreased     tissue trauma, and decreased pain after surgery.   "
70168|NCT02367352|"     The purpose of this study is to evaluate the safety and tolerability and determine the MTD to     subsequently define an RP2D of alisertib in combination with weekly paclitaxel in East Asian     patients with advanced solid tumors.   "
70169|NCT02367339|"     Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff   "
70170|NCT02367326|"     Inflammatory bowel disease (IBD) groups together Crohn's Disease (CD) and ulcerative colitis     (UC). Its prevalence is high representing approximately 0.4% of the population. The peak     incidence for these diseases ranges between 2 and 30 years of age with a second peak for CD     recently reported at 60. These diseases develop over time into complications requiring in 2/3     of cases surgical resection procedures in CD and colectomy in over 20% of cases. Cohort data     has recently shown that the early use of azathioprine from the first year would decrease the     need for surgery. Aside from biologics, azathioprine is the most widely used     immunosuppressant in IBD management. Its metabolism is highly variable in the overall     population since over 10% of patients are slow metabolizers and 15% fast metabolizers. This     explains partly treatment failures and side effects with thiopurines. A lot of research has     shown that metabolite measurement of azathioprine (6-TGN end methylated derivatives) could be     used clinically even if these results remain controversial. In fact, their positive     predicative value (PPV) in clinical response does not exceed 60%. This costly testing cannot     be done everywhere, is not reimbursed by national health services, and may not be used in     some countries. It is, however, key in order optimize these drugs at a time when only two     anti-TNFs are possible in the event of failure on thiopurines. Older studies have shown that     MCV and lymphonenia could be markers for thiopurine impregnation. Recently, an American study     provided a mathematic formula enabling to achieve over 80% PPV for the clinical response on     AZA but this calculation needs to be confirmed and it is, moreover, patented (costly).   "
70171|NCT02367313|"     This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo.     The objectives are to obtain safety and efficacy data in moderate to severe asthmatic     patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human     Rhinovirus infection.   "
70172|NCT02367300|"     A prospective, non-randomized trial to validate the database of brain electrical activity     recordings and clinical information collected from patients who present to the ED following     closed head injury.   "
70199|NCT02366936|"     The purpose of this study is to determine the effectiveness of the Tortle Midliner     positioning system in prevention and/or treatment of dolichocephaly, which can develop in     preterm infants during the hospital stay.      Specific Aim: Determine if the use of the Tortle Midliner is a more effective prevention and     treatment strategy for dolichocephaly than current standard of care intervention in the Duke     Intensive Care Nursery (ICN).   "
70200|NCT02366923|"     The study will explore in vivo lens dehydration rates across a 12hr wear period for the study     lenses.   "
70201|NCT02366910|"     The study will explore in vivo lens dehydration rates across a 12hr wear period for the study     lenses.   "
70173|NCT02367287|"     Although the diet of the US population meets or exceeds recommended intake levels of most     essential nutrients, the quality of the diet consumed by many Americans is sub-optimal due to     excessive intake of added sugars, solid fats, refined grains, and sodium. The foundations and     outcomes of healthy vs. unhealthy eating habits and activity levels are complex and involve     interactions between the environment and innate physiologic/genetic background. For instance,     emerging research implicates chronic and acute stress responses and perturbations in the     Hypothalamic-Pituitary-Adrenal axis in triggering obesity-promoting metabolic changes and     poor food choices. In addition, the development of many chronic diseases, including     cardiovascular disease, diabetes, cancer, asthma and autoimmune disease, results from an     overactive immune response to host tissue or environmental antigens (e.g. inhaled allergens).     A greater understanding is needed of the distribution of key environment-physiology     interactions that drive overconsumption, create positive energy balance, and put health at     risk.      Researchers from the USDA Western Human Nutrition Research Center are seeking volunteer study     participants for a cross-sectional metabolic phenotyping study of healthy people in the     general population. Observational measurements include the interactions of habitual diet with     the metabolic response to food intake, production of key hormones, the conversion of food     into energy: the metabolism of fats, proteins, and carbohydrates, characteristics of the     immune system, stress response, gut microbiota (bacteria in the intestinal tract), and     cardiovascular health. Most outcomes will be measured in response to a mixed     macronutrient/high fat challenge meal.   "
70174|NCT02367274|"     A prospective, non-randomized trial for the extension and replication of the development     database of brain electrical activity recordings and clinical information collected from     patients who present to the ED following closed head injury.   "
70175|NCT02367261|"     The current prospective clinical study's aim is to determine ABT's SPI implant survival rate,     crestal interproximal bone resorption during 24 months post implant insertion and to     assimilate the drilling sequence during the clinical use of SPI implants.   "
70176|NCT02367248|"     The main purpose of this study is to determine whether deferoxamine and xingnaojing injection     is effective and safe as a treatment for intracerebral hemorrhage.   "
70177|NCT02367235|"     The purpose of this study is to evaluate the efficiency of the Colpassist vaginal positioning     device during robotic-assisted sacrocolpopexy.   "
70178|NCT02367222|"     The purpose of this database study is to assess if Arepanrix™ vaccination during the 2009     pandemic was associated with an increased risk of multiple sclerosis (MS) in Manitoba,     Canada.   "
70179|NCT02367209|"     In the recent years a novel method for functional lung imaging called Fourier decomposition     MRI (FD MRI) has been introduced that allows for simultaneous assessment of regional lung     perfusion and ventilation-related information without exposure to ionizing radiation or     administration of intravenous or inhalational contrast agent. In this project, the     investigators plan to investigate whether Fourier decomposition (FD) MRI is able to provide     similar clinical information on regional lung perfusion as the standard methods SPECT/CT and     DCE MRI in patients with COPD.   "
70181|NCT02367183|"     This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and     to evaluate its safety in subjects with active Crohn's disease.   "
70182|NCT02367170|"     Investigators will assess the effect of exercise on markers of inflammation and protein     catabolism. This research study will further our understanding of how treating Chronic     Critical illness (CCI) - related respiratory muscle weakness with strength training can not     only improve muscle function, but also potentially blunt the inflammation and catabolism of     Peristent Inflammation/Immunosuppression and Catabolism (PICS).   "
70186|NCT02367105|"     The prevalence of obesity in Veterans is greater than in the general population, and even     more so among users of the VA Health Care System. In addition, the population of obese older     Veterans is rapidly increasing as more baby boomers become senior citizens. In older     Veterans, obesity exacerbates the age- related decline in physical function and causes     frailty which predisposes to admission to a VA chronic care facility. However, the optimal     clinical approach to obesity in older adults is controversial because of the concern that     weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and     bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any     guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of     testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and     reverse frailty in obese older Veterans and thus prevent their loss of independence and     decrease demand for VA health care services.   "
70187|NCT02367092|"     The purpose of this study is to learn more about the effects of exercise on functional status     and outcomes on patients with end-stage liver disease on the liver transplant waiting list     and who have undergone liver transplantation.   "
70188|NCT02367079|"     To investigate the effect of hand massage, switched on diathermy or sham/switched off     diathermy on DOMS in a group of athletes suffering DOMS after a ski mountaineering race.   "
70189|NCT02367066|"     A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated     Doses for 3 days in Subjects with Type 2 Diabetes Mellitus   "
70212|NCT02366767|"     The overall aim of this research proposal is to determine the safety, feasibility and     efficacy of an automatic closed-loop insulin delivery system.   "
70302|NCT02365584|"     The primary objective of the study is to evaluate the impact on quality of life of Lanreotide     Autogel 120 mg in combination with standard care, in comparison to the standard care alone,     in subjects affected by inoperable malignant bowel obstruction.   "
70190|NCT02367053|"     The trial is a randomized, double-blind First in Human trial to evaluate the safety and     tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D     (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts.      Part 1 includes dose escalation of ZP4207 in cohorts of 8 subjects. In each cohort, subjects     will be randomized 3:1 to receive either a single ascending dose of ZP4207 (6 subjects) or a     single fixed dose (SD) of native glucagon (2 subjects). The doses will be administered s.c.     in 4-5 cohorts and i.m. in 3 cohorts.      Part 2 includes two sequence groups of 10 hypoglycemic T1D subjects. The subjects will be     treated with fixed single doses of ZP4207 and native glucagon s.c. in a sequential cross-over     design in a randomized treatment order.   "
70191|NCT02367040|"     The purpose of this study is to evaluate whether copanlisib in combination with rituximab is     superior to placebo in combination with rituximab in prolonging progression free survival     (PFS) in patients with relapsed iNHL who have received one or more lines of treatment,     including rituximab. Purpose of the study is also to evaluate the safety and tolerability of     copanlisib.      Approximately 567 patients will be randomly assigned in in blinded treatment arms copanlisib     plus rituximab or placebo plus rituximab.      Copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo dosing will     be administered on the same days as copanlisib.      Rituximab dose is administered weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day     1 of Cycles 3, 5, 7 and 9. The maximum administration of rituximab is 8 times.      Copanlisib or placebo treatment will be continued until disease progression, unacceptable     toxicity, or until another criterion is met for withdrawal from the study treatment.      Following the end of treatment visit, patients will enter either the Safety follow-up or the     Active follow-up period.      The efficacy is measured by duration of progression-free survival (time between randomization     and onset of a further progression of disease, or death from any cause). Progression of     disease will be determined by radiologic tumor assessments to be performed at screening, as     well as during the active follow up period tumor assessments every 8 weeks during Year 1,     every 12 weeks during Year 2, and every 24 weeks during Year 3.      Blood samples will be collected for safety analysis and pharmacokinetic analysis. Archival     tumor tissue and blood samples will be collected for biomarker analysis and for central     pathology review, fresh biopsy tissue and bone marrow will be collected but not mandatory.   "
70192|NCT02367027|"     Rivaroxaban is a substance developed for use in the treatment of blood coagulation     disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in     the blood vessels. Excessive coagulation activity can occur in children as well, and     rivaroxaban is therefore being developed for the treatment of thromboembolic events in     children and adolescents. As small children are often unable to swallow tablets, an oral     suspension (mixture of a liquid containing finely distributed solids) has been developed     which allows dosing according to body weight.The objective of this trial is to compare the     bioavailability (proportion of a substance that remains available unchanged in the blood     circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension     and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential     influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after     consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown     products (metabolites) in blood), safety and tolerability will be assessed.   "
70193|NCT02367014|"     This study will be a Phase 1/2, multi-center, randomized, double-blind, multiple ascending     dose, placebo-controlled study, enrolling an anticipated 36 subjects with mitochondrial     myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety,     tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient     population.   "
70194|NCT02367001|"     Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the     general practitioner involvement (signature) and a more personalized communication in     invitation letters to organized screening of breast, colorectal and cervical cancers.      The hypothesis on which this project is based is that communication is probably more     effective if the receiver feels personally targeted by invitation letters (Dear Martin, I     am writing ...) and if he knows the issuer (his general practitioner rather an unknown     person).   "
70219|NCT02366676|"     The purpose of this study is to evaluate the efficacy of Combined Intravesical Therapy With     Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory to     Escherichia Coli Extract   "
70195|NCT02366988|"     Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and     in these cases, endoscopy and surgery are the treatment modalities of choice.     Morbid-mortality of these procedures is similar and physicians face the decision between     endoscopy and surgery for this group of patients, with no randomized controlled trial     available comparing these procedures.      The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of     surgical and endoscopic interventions in the management of bile duct stricture for chronic     pancreatitis.      The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end     points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical     procedures, length of stay. Eighty-six patients need to be included.   "
70196|NCT02366975|"     There are many evidences in the literature showing that the metabolic syndrome (MetS) is     associated with BPH / LUTS. There are also numerous evidence that hypogonadism is associated     with both conditions, thus being one of the most probable pathogenetic factor underlying the     association between MetS & BPH / LUTS.      Preliminary evidences from observational clinical studies have shown that treatment with     testosterone replacement in hypogonadal patients with MetS reduces the symptoms of lower     urinary tract symptoms (LUTS) associated with BPH. Preclinical studies performed by the     investigators research group show in an experimental model of metabolic syndrome the     occurrence of marked inflammation and tissue remodeling of the prostate gland, which is     prevented by treatment with testosterone replacement (Vignozzi et al., 2012). There is     therefore a need for a clinical trial to demonstrate the effect of treatment with     testosterone replacement in reducing the inflammation of the prostate and its effectiveness     in improving the symptoms related to inflammation in patients with prostatic BPH associated     with metabolic syndrome and testosterone deficiency .      The aims of the present study is to evaluate the effectiveness of testosterone replacement     therapy compared to placebo in reducing signs and symptoms of inflammation of the prostate     and LUTS symptoms in hypogonadal patients with metabolic syndrome and BPH who are candidates     for radical prostatectomy simple.      For this purpose both clinical (assessment of specific symptoms of prostatitis assessed by     questionnaire National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI and     assessment of the symptoms of LUTS and questionnaires International Prostate Symptom Score,     IPSS), ultrasound (transrectal ultrasound evaluation of markers of prostatic inflammation:     macrocalcifications, inhomogeneity etc.), biochemical (evaluation of inflammatory cytokines     in the semen), urodynamic and histology (histomorphometric and immunohistochemical analysis     of samples prostate derived from patients enrolled in the study or not treated with     testosterone) scores will be performed. Along with the symptoms and clinical signs of     prostate inflammation and LUTS, the effect of testosterone therapy or placebo on penile     erection will be also evaluated.   "
70197|NCT02366962|"     The purpose of this study is to confirm the safety until Day 29 after injection of a single     dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older   "
70202|NCT02366897|"     The project is aimed at addressing the fundamental issue in antipsychotic therapeutics -the     balance between mental state benefits and neurological risks.The latter cannot be     overestimated and clinical skills in themselves are inadequately sensitive to refine     practice. With all current and pipeline antipsychotics based on central dopamine blockade,     there is little prospect that therapeutics can be improved by advances in pharmacology alone.      The project uses, for the first time, technology that is not only simple, real-life and     user-friendly but modern and socially held in high regards. The proposal depends on     patients receiving antipsychotic medication where clinically indicated. At all times,     subjects will receive clinically-indicated therapy. The major ethical issue will relate to     the issue of informed consent in those suffering from major psychiatric disorder. This is a     routine consideration in psychiatric practice and the investigators will seek guidance on     this from the Consultant Psychiatrist responsible for potential participants and would not     proceed with initial approaches in cases of doubt or absence of capacity.      This is a pilot/feasibility study with no intention to utilise the data for commercialisation     of the device or to expand the CE (Conformité Européenne) marking.   "
70203|NCT02366884|"     The cell behavior that the investigators regard as malignant, including: cell autonomy;     invasion and digestion of surrounding normal tissues; migration and colonization of distant     organs; ability to develop resistance to drugs, temperature, or radiation; and ability to     kill the host, are not only characteristics of cancer cells, but of pathogenic and/or     opportunistic unicellular organisms (bacteria, fungi and protozoa). Rudolf Virchow     (1821-1902), the father of modern pathology, first pointed out the resemblance between the     biological behavior of cancer cells and that of single-celled organisms when causing     infections. He thought, incorrectly, that cancer cells were cells infected with bacteria and     had acquired their pathogenic behavior from them. Others later postulated that the behavior     of cancer cells was likely due to the re-expression of past traits and behaviors (atavism)     derived from their past evolutionary experience as independent, single-celled organisms from     which all cells in multicellular organisms originated. In other words, the behavior of     pathogenic unicellular organisms, including: unlimited replicative potential; capacity for     invasion, migration, and metastases; abilities to evade the host's immune system, to generate     multi-drug resistance; and to kill a host, are what the investigators define as cancer when     one of the investigators cells re-express these past ancestral traits. This reversion or     de-evolution of a differentiated cell to its ancestral undifferentiated, unicellular form has     been named Atavistic Metamorphosis.      This does not imply that cancer cells are bacteria, protozoa, or yeasts. It means that cancer     cells express functions and/or behaviors similar to their ancestral parents, the unicellular     organisms from which our cells originated.      If this is true, a combination of drugs that are effective to eradicate certain unicellular     organisms may work in cancer treatment.      The principal objective of this study is to determine whether there is a benefit for patients     with advanced, metastatic and terminal cancers to be treated with combinations of selected     drugs conventionally used in medical practice to kill bacterial, fungal and protozoal cells.   "
70204|NCT02366871|"     The study will evaluate the incidence of major bleeding (including clinically relevant     non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with     apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD     for 28 days post surgery.   "
70205|NCT02366858|"     The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the     need to use the 19 gauge needle for core tissue procurement.   "
70206|NCT02366845|"     This study plans to learn more about transfusion of a human blood component called plasma in     patients who have liver problems. Patients are asked to be in this study because they have     liver disease and therefore may require the transfusion of plasma.      The dose of plasma required to reach certain blood clotting laboratory targets is usually     determined by clinicians. Due to the complexity of the patient's blood clotting disorder,     determining the appropriate dose of plasma is very difficult. The investigators have     developed a dosing table based on information from other patients with liver disease and the     investigators are testing it to see if it is a more accurate dosing tool then clinician     chosen dosing of plasma in patients with liver disease who need one or more plasma     transfusions   "
70207|NCT02366832|"     The purpose of this study is to determine if treatment with percutaneous cryoablation yields     significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).   "
70278|NCT02365896|"     Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between     Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal     Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced     Gastric Cancer   "
71952|NCT02343952|"     This is an open label, multi-institutional, single arm phase II trial of consolidation     therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in     patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or     blinding is involved.   "
70208|NCT02366819|"     This pilot clinical trial studies genetic analysis-guided irontecan hydrochloride dosing of     modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin     (mFOLFIRINOX) in treating patients with gastroesophageal or stomach cancer that has spread     from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as     fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Leucovorin calcium may also help     fluorouracil work better. Genetic analysis may help doctors determine what dose of irinotecan     hydrochloride patients can tolerate.   "
70209|NCT02366806|"     This study is being conducted to investigate the effect of a more in-depth education plan for     patients with breast cancer. Patients will be randomized to receive either the standard     education plan during their breast cancer treatment or they will receive in-depth education     about their breast cancer treatment. In order to see what kind of effect the different     education plans have, patients will fill out three identical questionnaires during the course     of treatment.   "
70210|NCT02366793|"     The potential consequences after breast cancer surgery are joint pain and sensitive     disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy     has been shown to be effective at increasing shoulder range of motion restriction. However,     literature does not consider specific manual therapy techniques, which means peripheral     nerves and articular capsule have not been taken into account. These two tissues are     potentially damaged structures during surgery and they are main responsible for shoulder     range of motion restriction The main objective of this study is to pilot the effectiveness of     accessory joint and nerve mobilization techniques in order to get an overview of the     articular capsule and nerve dysfunctions involvement in shoulder motion restriction.   "
70211|NCT02366780|"     Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive     factors for the health and development of infants.Colostrum, which is produced in low     quantities for the first 3 to 4 days after birth, is rich in immunologic components and     developmental factors.      Breastfeeding difficulties during the first days of life of an infant are common. Moreover,     not all infants can be directly fed at the breast.      Therefore, breast milk feeding at this early stage is initiated and promoted by the     expression of breast milk either manually or by use of a pump. Whether the method of milk     expression at this stage has a qualitative impact on colostrum is currently unknown.      The purpose of this randomized controlled study is to compare the effect of manual expression     with electric pump expression upon the macronutrient composition of breast milk.   "
70213|NCT02366754|"     The purpose of this study is to address the need for targeted treatments that induce     functional and structural changes in the brain, ultimately improving neurobehavioral     functioning, the investigators propose examining the therapeutic effectiveness of repetitive     Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for     persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months     after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the     relationship between neurobehavioral changes and net neural effects, and to identify and     define the neural mechanisms related to neurobehavioral improvements by providing 30 active     or placebo rTMS sessions.   "
70214|NCT02366741|"     Small cell lung cancer (SCLC) harbors a high risk for brain metastases. Prophylactic whole     brain radiotherapy (PCI)) is the standard treatment for these patients after completing     chemo-radiotherapy to the chest, with a 5% survival advantage. Recent data suggest minimal     risk for hippocampal involvement in these patients. There is no published data thus far     testing the effect of hippocampal sparing during WBRT on the patient's neuro-cognitive     function, QOL, and survival.., The goals of the proposed study are to assess prospectively     the neurocognitive changes in patients with LD SCLC who are candidates for PCI before, and     periodically after PCI   "
70215|NCT02366728|"     This randomized phase II study will assess the impact of pre-conditioning on migration and     survival among newly diagnosed glioblastoma (GBM) patients who have undergone definitive     resection and completed standard temozolomide (TMZ) and radiation treatment, as well as the     impact of tetanus pre-conditioning and basiliximab together on survival. After completing     standard of care radiotherapy with concurrent TMZ, patients will be randomized to 1 of 3     treatment arms: 1). receive cytomegalovirus (CMV)-specific dendritic cell (DC) vaccines with     unpulsed (not loaded) DC pre-coinditioning prior to the 4th vaccine; 2). receive CMV-specific     DC vaccines with Tetanus-Diphtheria Toxoid (Td) pre-conditioning prior to the 4th vaccine;     3). receive basiliximab infusions prior to the 1st and 2nd DC vaccines along with Td     pre-conditioning prior to the 4th vaccine. A permuted block randomization algorithm using a     1:1:1 allocation ratio will be used to assign patients to a treatment arm. Randomization will     be stratified by CMV status (positive, negative), with the assignment to arms I and II being     double-blinded. Effective March 2017, randomization to Group III has been terminated.   "
70216|NCT02366715|"     Bronchiolitis is an acute lower airway infection caused by a viral infection. It is a major     cause of winter admissions to pediatric wards. Accepted therapies include oxygen support and     IV fluids, whereas other supportive therapies such as inhalations are of questionable     benefit. Moderate to severe cases are a source of distress to patient, parents and medical     staff often necessitating Pediatric Intensive Care Unit admission. Heated Humidified High     Flow Nasal Cannula (HHHFNC) therapy has been shown lately to improve the work of breathing,     oxygen saturation, and CO2 pressure (PCO2) values as well as decrease PICU admissions and     intubation rates. We planned a prospective and retrospective study in order to check the     feasibility of using HHHFNC in a primary pediatric ward and its effect on clinical well     being, respiratory status and PICU admission.   "
70217|NCT02366702|"     The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal     plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral     transfemoral walking with passive prostheses versus powered prostheses. The pilot study will     collect data from three subjects with bilateral transfemoral amputations. Differences in     kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered     components may indicate benefits for clinical application of powered devices for persons with     lower limb amputation.   "
80068|NCT02237859|"     We are doing this research study to determine if taking vancomycin in addition to a     broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium     difficile infection.   "
70220|NCT02366663|"     This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination     chemotherapy compared with combination chemotherapy alone before stem cell transplant in     treating patients with diffuse large b-cell non-Hodgkin lymphoma that has returned after a     period of improvement. Radioactive substances linked to monoclonal antibodies, such as     90-yttrium ibritumomab tiuxetan, can bind to cancer cells and give off radiation which may     help kill cancer cells. Drugs used in chemotherapy, such as carmustine, etoposide phosphate,     cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. It is not yet known whether 90-yttrium ibritumomab tiuxetan and BEAM before a stem     cell transplant are more effective than BEAM alone in treating patients with diffuse large     b-cell non-Hodgkin lymphoma.   "
70221|NCT02366650|"     The purpose of this prospective, non-interventional clinical study is to assess the clinical     validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin     (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the     presence of organ dysfunction, or outcome, of patients with organ dysfunctions following     emergency department admission or hospitalization. Secondary objectives are to identify novel     putative biomarkers and to identify risk factors for negative long-term effects of acute     critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the     quantitative determination of Heparin Binding Protein in human plasma.   "
70222|NCT02366637|"     This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with     moderate to severe Chronic Obstructive Pulmonary Disorder.   "
70253|NCT02366221|"     The specific aim of the study is to obtain long-term follow-up information on patients who     have completed their standard clinical care in the Orthopaedic Hand and Upper Extremity     Service. The study will help to qualify and quantify long-term recovery and outcomes from     uncommon upper extremity fractures, as well as non-fracture bone and joint conditions. The     hypotheses vary, but generally focus on the patterns of injury, the results of treatment and     the complications encountered.   "
70223|NCT02366624|"     The purpose of this study is to evaluate the effect of bariatric surgery in bile acid     homeostasis and its interrelationship with the metabolic changes induced by the surgery.      This study contemplates the following hypothesis:        -  Bariatric Surgery induce a new study state in bile acid homeostasis with higher bile          acid synthesis in association with increased bile acid content.        -  The major effects of bariatric surgery on bile acid synthesis and is observed one month          after surgery with a progressively decline during the first year of follow-up.        -  Gastric bypass increases serum bile acid content, postprandial plasma bile acid response          and fecal bile acid excretion.        -  Serum bile acids changes induced by gastric bypass are positively correlated with          changes in gastric inhibitory polypeptide (GIP) levels and postprandial concentration of          insulin and glucagon like peptide-1 (GLP-1) and inversely correlated with thyrotropic          hormone (TSH) and postprandial concentration of glucose.        -  Changes in postprandial plasma bile acid response induced by gastric bypass positively          correlates with changes in postprandial concentration of insulin, GLP-1 and peptide YY          (PYY) and inversely correlates postprandial response of ghrelin and glucose.   "
70224|NCT02366611|"     The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS)     can reduce pain perception associated with the effects of receiving definitive radiation     therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.   "
70225|NCT02366598|"     The objectives of this trial are to assess the health benefits of acute hemp protein     consumption compared to soybean protein and a non-protein control on: 1) blood glucose,     appetite and blood pressure for one hour following consumption, 2) food intake at an ad     libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure     following the ad libitum meal to determine the second meal effect of hemp protein.   "
70226|NCT02366585|"     The main purpose of the trial is to investigate the effect of locally delivered ciclosporin     as an adjunct to non-surgical mechanical debridement in the treatment of chronic     periodontitis and to compare it to mechanical debridement alone.   "
70227|NCT02366572|"     The objectives are to test the acute effects of different cereals containing pulse     ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2)     food intake two hours following consumption of pulse products.      We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose,     insulin, appetite and food intake responses compared to non-pulse cereals.   "
70228|NCT02366559|"     The primary objective of this study is to compare the efficacy and risk of adverse events of     electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG)     laser for the treatment of flat seborrheic keratoses.      This study is a pilot study designed to determine feasibility of these procedures.   "
70229|NCT02366546|"     Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene     transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid     tumors.   "
70230|NCT02366533|"     The goal of ATN 093 is to determine program-level factors associated with the effectiveness     of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent     Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the     various LTC programs at the AMTUs and then examining the association between the LTC program     characteristics (providers, practices, and systems) and the proportion of Human     Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care     and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit     of analysis and not the youth themselves.   "
70231|NCT02366520|"     The purpose of this study is to determine whether a handheld mirror helps to reduce child     behavior problems during dental treatment. It will be tested by randomized crossover design.     Child participants will receive dental treatment under two conditions: during one of the     treatment days the child will be given a handheld mirror; another treatment will be done     without the child having the mirror. Each condition will be assign on separate days, and the     day, which the child has the mirror, will be assigned by chance.   "
70320|NCT02365519|"     The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the     reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when     administered topically for up to 42 days, in subjects with severe dry eye disease.   "
70232|NCT02366507|"     Traditional devices to measure blood pressure include automatic sphygmomanometer (pressure)     cuff systems or manual blood pressures obtained by auscultation (listening with a     stethoscope). Both these techniques fail to provide accurate and consistent blood pressure in     the hypotensive (low blood pressure) state, which is often encountered in emergency     departments and intensive care units. Alternately, invasive arterial pressure measurement is     time-intensive, painful, expensive, and risks include bleeding, infection, and neurovascular     injury.      In clinical practice, the Doppler velocimetry system is occasionally used in hypotensive,     critically-ill patients when an immediate systolic blood pressure measurement is vital for     clinical and therapeutic management. With a technique similar to that used to obtain a manual     blood pressure, the Doppler velocimetry system can be used in place of the auscultation of     the brachial pulse to accurately determine the systolic blood pressure. It is currently     unknown whether additional information can be obtained by evaluation of the Doppler waveform     in healthy vs. critically-ill patients. The goal is this project is to digitally record     Doppler waveforms of critically-ill patients in the Emergency Department (ED) via a standard     8MHz (fetal) Doppler probe, correlate the Doppler readings with current blood pressure and     heart rate, and determine if waveform shapes and parameters are predictive of hemodynamic     compromise.   "
70233|NCT02366494|"     Identify exosomal micro RNA that predict responses to ADT   "
70234|NCT02366481|"     Given that glutamate carboxylation or decarboxylation is key to the metabolic role of     osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is     critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and     its subsequent effect on glucose metabolism in clinical trials. The purpose of this     randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether     eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in     blood associated with diabetes risk.   "
70235|NCT02366468|"     The purpose of this study is to demonstrate that the change of best corrected visual acuity     (BCVA) is comparable in patients treated with ranibizumab at the discretion of the     investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).   "
70236|NCT02366455|"     The right-sided double lumen endobronchial tube (R-DLT) is seldom. The principal cause of     reticence for using the R-DLT are the difficult positioning of its lateral orifice in front     of the origin of the right upper lobe (RUL) and the variability of the length of the right     main stem bronchus (RMSB). Both the angle between the right upper lobe (RUL) bronchus origin     and the RMSB and the length of the RMSB can be measured with high resolution CT-scan. These     measures can be useful in clinical practice as they help to determine when a R-DLT should not     be used or used with caution when facing a large variation of the angle of the RUL or a     proximal implantation of a RUL bronchus .   "
70237|NCT02366442|"     The overarching goal of the proposed study, named SYNERGY, is to explore relationships among     balance performance, cognitive function, affective dysregulation, as they relate to the     community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the     development of a better outcome models for the clinicians in facilitating effective community     re-integration in Veterans with TBI   "
70238|NCT02366429|"     Randomized controlled trial evaluating an Internet-delivered Cognitive Behavioral Therapy     (ICBT) adapted for pregnant women suffering from antenatal depression. The ICBT-program will     be added to treatment as usual (TAU) and compared to TAU only.      Participants (n=60) are recruited from all over Sweden (only Swedish citizens can     participate) and are assessed and treated on a distance via a secure web platform and     telephone.   "
70239|NCT02366416|"     The aim of this study is to investigate the effects og physical exercise on bloodglucose and     pain from the musculoskeletal system in patients with type 2 diabetes.      The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long     term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients     will be stratified to patients with a high or a low degree of complications related to     diabetes.   "
70240|NCT02366403|"     Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to     a traumatic event. The purpose of this study is to determine whether a breathing meditation     technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as effective as     the standard intervention. Patients' PTSD symptoms will be monitored before treatment, at the     end of treatment, one month after treatment and 12 months after treatment.   "
70241|NCT02366390|"     The purpose of this trial is to determine whether a minimal homebased psychoeducative     intervention is effective in management of anxiety and dyspnea in patients with severe     chronic obstructive pulmonary disease.   "
70242|NCT02366377|"     The purpose of this study is to evaluate the efficacy and safety of 3 different doses of     SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving     treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate     glycemic (blood sugar) control.   "
70243|NCT02366364|"     The purpose of this study is to assess the safety and tolerability of multiple oral (PO)     ascending doses of NRX-1074 in normal healthy volunteers.   "
70244|NCT02366351|"     The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824     over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the     effect of SHR3824 to placebo when given in oral doses.   "
70245|NCT02366338|"     Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was shown     to decline by oral anticoagulant therapy. The investigators intended to evaluate appropriate     use of anticoagulants in non-valvular AF patients.   "
70246|NCT02366325|"     The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and     pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic     kidney disease (CKD) who are on hemodialysis.   "
70247|NCT02366312|"     The purpose of this study is to determine how well a daily dose of 150 mg of Erivedge     (vismodegib) reduces Keratocystic odontogenic tumor (KCOT) size, and to evaluate the safety     of this dose. Erivedge is FDA-approved for use in adults with a specific type of skin cancer.     However, the drug is experimental for patients with KCOT.   "
70248|NCT02366299|"     Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of     delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in     serum.   "
70249|NCT02366286|"     The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States     (US) is relatively low. However, immigrant populations in the US from Asia and sub-Saharan     Africa have substantially higher prevalence than the general population and are consequently     at a significant risk for hepatocellular carcinoma (HCC). Indeed, the age-adjusted incidence     rates for HCC in the US have tripled from 1975 to 2005. As the population demographics have     changed, the 2000 US census estimated the number of Somalis in Minnesota at 25,000 but     current estimates put the number at around 50,000 due to primary refugee arrivals as well as     secondary immigration from other states. There is no available data for Somali immigrants in     the US on HBV and HCV prevalence, HBV and HCV genotypes/subgenotypes, and genetic and     immunologic risk factors predisposing Somalis to HBV and HCV and the subsequent development     of HCC. Therefore. this study will fill these gaps in the Somali population to understand the     relative importance of HBV and HCV infections in causation of HCC.   "
70250|NCT02366273|"     Patients with psoriasis will be evaluated. The investigators will collect personal history,     concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired     fasting glucose and impaired glucose tollerance. The aim of the study will be to evaluate if     there is a correlation among inflammation, insulin-resistance and psoriasis.   "
70251|NCT02366247|"     This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1     (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from     Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with     chronic hepatitis B.   "
70252|NCT02366234|"     AIM:      The aim of this study is to assess whether patients with an acute distal tubercle fracture of     the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms     and disability 6 months after injury as the average for the normal population.      NULL HYPOTHESIS:      Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities     of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway     and 10.9 in the United States) 6 months after injury when treated symptomatically with a     removable brace.   "
70256|NCT02366182|"     Failed intubation and ventilation in obstetrics remains one of the most common causes of     death directly related to anesthesia. The reported incidence of failed intubation in     obstetrics is 1:300, which is significantly higher than that in the non-obstetric population.     A clinical screening test with high sensitivity and specificity for prediction of difficult     airway may help reduce morbidity and mortality from general anesthesia. Few studies have     identified increased neck circumference as the best single predictor of problematic     intubation. However the cutoff point of this test for identifying patients at high risk of     difficult intubation is not clear.      The aim of this study is to determine the optimal cutoff point, which validates prediction of     difficult ventilation and/or intubation for obstetric patients. Preoperative airway     assessment will be done including neck circumference. Intraoperative difficult ventilation     and/or intubation will be recorded. Optimal cutoff point of neck circumference will be     calculated by Receiver Operating characteristics (ROC) curve.   "
70257|NCT02366169|"     This registry is intended as an observational, post-marketing surveillance tool. The registry     allows collection of baseline demographics and user experience of the commercially available     MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large     number of subjects during use outside the constraints of a prescribed clinical study.   "
70258|NCT02366156|"     This study will evaluate the effects of encapsulated botanical extracts, previously shown to     inhibit the enzyme diacylglycerol-acyltransferase-1 (DGAT-1) in vitro, on fasting and     postprandial lipid metabolism during an oral fat tolerance test (OFTT) in apparently healthy,     overweight and obese adult men and women.   "
70259|NCT02366143|"     This randomized, open-label study will evaluate the safety and efficacy of atezolizumab in     combination with carboplatin + paclitaxel with or without bevacizumab compared with treatment     with carboplatin + paclitaxel + bevacizumab in chemotherapy-naïve participants with Stage IV     non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (Atezolizumab +     Carboplatin + Paclitaxel), Arm B (Atezolizumab + Carboplatin + Paclitaxel + Bevacizumab), or     Arm C (Carboplatin + Paclitaxel + Bevacizumab).   "
70260|NCT02366130|"     The goal of this clinical research study is to learn if Xofigo® (also called Ra-223     dichloride) combined with hormone therapy and denosumab can help to control breast cancer     that has spread to the bones and/or bone marrow. The safety of this study drug combination     will also be studied.   "
70261|NCT02366117|"     The study design is that of a cluster randomised controlled trial      The aims of the study were: 1) to assess the quality of care of the residential units for     people with long-term mental disorders; 2) to design a training intervention for the staff of     the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and     8 months after it ended.      The main outcome variable was level of activity of the users. Secondary outcome variables     were the QuIRC dimensions.      The selection of the sample was by residential units for people with long-term mental     disorders.      The inclusion criteria were all the middle and high-support residential units in Portugal.     Units that had only one type of service users (e.g., mental retardation, dementia) were     excluded.      The quality of care of the units was assessed with the QuIRC filled on line by the managers     of the units and validated with Service Users Interview Schedule, a face-to-face interview     with the users (users that could not give informed consent or collaborate in the interview     were excluded).   "
70262|NCT02366104|"     BSHA is a cohort study of healthy elderlies enrolled voluntarily. It has been ongoing since     December 2008. And the purpose of this study is to assess clinical and biological markers of     cardiovascular risk in very elderly participants.   "
70263|NCT02366091|"     The investigators are studying whether anti-inflammatory agents can improve abnormal coronary     artery function in patients with coronary artery disease (CAD) and abnormal coronary artery     endothelial function.   "
70264|NCT02366078|"     The purpose of this study is to investigate the outcomes of the Stress Management and     Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota.     Feasibility of a blended in-person and online teaching approach of the program will also be     evaluated.   "
70321|NCT02365506|"     This study will evaluate the effect of oral eleclazine (GS-6615) on QTc interval, safety, and     tolerability in adults with long QT2 syndrome.   "
70265|NCT02366065|"     - Lowering intraocular pressure is the only proven treatment for glaucoma. Medications,     almost always in the form of eye drops, are a mainstay for lowering intraocular pressure. Eye     drops have the disadvantage of being difficult to administer and can have adverse effects on     the surface of the eye and the surrounding tissues. Lowering intraocular pressure can be     accomplished with oral carbonic anhydrase inhibitors, but the many systemic side effects of     these agents relegates them to drugs of last resort. Therefore, an effective, well-tolerated,     oral agent would be an important addition to the treatment of glaucoma. The hypothesis is     that oral acetaminophen can lower intraocular pressure to a clinically significant degree in     a dosing regimen that is both safe and convenient. The research is important because     acetaminophen is inexpensive, available over-the-counter, and has a well known safety and     side effect profile.   "
70266|NCT02366052|"     The main aim of the study is to determine if an oral supplementation of the LCS has a     beneficial effect by itself or even enhances the beneficial effects of a moderate life-style     intervention on the progression of NAFLD in humans.   "
70267|NCT02366039|"     This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric     Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and     ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard     histopathology   "
70268|NCT02366026|"     The primary objective is to compare & evaluate between the treatment groups the changes in     decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax     placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ &     CD8+ T cell counts along with increased HIV immunity.   "
70269|NCT02366013|"     This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1     vaccine.   "
70270|NCT02366000|"     The aim of this study is to identify parent-children communication in relation to health risk     behaviors (smoking, drinking and illegal drug taking) in adolescents, and to enhance better     parental skills in preventing these behaviors in children.   "
70271|NCT02365987|"     The purpose of this study is to investigate whether there are differences in postprandial     metabolic indices following interesterified fats used in commercial spreads versus the     corresponding un-interesterified blend.   "
70272|NCT02365974|"     Uncontrolled blood pressure represents the main factor in the development of target organ     lesions and, consequently, cardiovascular events, which are the leading cause of morbidity     and mortality worldwide. In most cases resistant hypertension is preceded by target organ     lesions, and is strongly influenced by risk factors or associated diseases. To control this     disease requires an adequate and intense therapeutic approach that includes lifestyle changes     and the use of several antihypertensive drugs. However, the results are not always     satisfactory despite intensive treatment. Of the different pathophysiological mechanisms     involved in the pathogenesis of resistant hypertension (RH), two, sympathetic overstimulation     and therapies that block the sympathetic system, have been widely studied. But, these     approaches are invasive and expensive. Another possible approach is by transcutaneous     electrical nerve stimulation (TENS), a non-invasive method that modulates activity by     inhibiting primary afferent pathways using low-frequency transcutaneous electrical     stimulation. Some studies have shown that TENS reduces blood pressure in patients with     hypertension. The current study will evaluate the effect of applying TENS in the     cervicothoracic region of subjects with resistant hypertension, seeking to develop a new low     cost and readily available therapy to treat this group of hypertensive individuals.   "
70273|NCT02365961|"     Patients undergoing a hip scope procedure will be recruited for this study. They will be     randomized to either receive a nerve block or no nerve block (pain medicine only). Pain     levels and clinical outcomes will be assessed through 3 months post-operatively.   "
70274|NCT02365948|"     This study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and     evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to receive     one of 3 dose levels of CZP or placebo. The total study duration will be approximately 71-94     days for each subject.   "
70275|NCT02365935|"     The investigators primary outcome was to evaluate the effectiveness in term of Overall     Survival (OS) and disease free interval (DFI) of two different platinum-based chemotherapic     regimen (3 and 6 cycles) for treatment of Locally Advanced Cervical Cancer (LACC) (IB2-IIB)     previously treated with Neoadjuvant Chemotherapy Plus Radical Surgery (NACT+RS).      The secondary outcome was to evaluate and compare safety, in term of toxicity profile, of the     two treatment options.   "
70276|NCT02365922|"     Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of     rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes:     frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration     syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is     to build a FTLD clinical research consortium to support the development of FTLD therapies for     new clinical trials. The consortium, referred to as Advancing Research and Treatment for     Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner     with six patient advocacy groups to manage the consortium. Participants will be evaluated at     14 clinical sites throughout North America and a genetics core will genotype all individuals     for FTLD associated genes.   "
70277|NCT02365909|"     Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in     approximately 1% of cases when performed in obstetric patients. The gold standard treatment     for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back     into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood     through the needle and into the epidural space to form a clot over the insult in the tissue     layer that causes the headaches. The investigators want to test the efficacy of using a less     invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has     been used for many years in the treatment of migraines and cluster headaches, and there are     several case reports of its use to successfully treat PDPH as well. SPGB simply involves     applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that     cause the headache. The investigators hope that the SPGB will reduce the number of PDPH     patients that require and EBP.   "
70279|NCT02365883|"     The purpose of this study is to image human prostate tissue using a new transrectal     photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed once     the specimen has been surgically removed. We hope to see what we can visualize with our     device as this has never been done before. Eventually, we hope to use a similar device to     image the prostate in men being seen by their doctor for prostate cancer.   "
70280|NCT02365870|"     This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing     anxiety in people with Parkinson's disease.   "
70281|NCT02365857|"     A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and     side effect profile of different dose levels of Dexmedetomidine added to subarachnoid     bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal     anesthesia. The investigators ultimate goal is to find out the least effective dose which     will be associated with minimal or no side effects. The primary outcome will be the time to     two sensory block segment regression.   "
70282|NCT02365844|"     The purpose of this study is to characterize the blood supply at the base of the tongue and     within the tonsil region. We hypothesize that high-resolution Narrow Band Imaging (NBI) will     improve the diagnosis of oropharyngeal carcinoma (OPC). The goal is to provide the better     assessment of tumor and thus providing better preoperative expectations to patients with OPC     or tumor extent prior to radiation therapy.   "
70303|NCT02365571|"     This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on     the body. There will be 3 parts to this study.      Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for     each participant. Each participant will receive two doses of LY3154207, if part A is     completed.      Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each     participant. Part B includes collecting fluid from the spinal column to measure levels of     LY3154207.      Part C will include a single dose of LY3154207 given alone and then a second dose given along     with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for     each participant.      Participants may only enroll in 1 of the 3 parts of the study.   "
70283|NCT02365831|"     While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a     standard strategy for HER2-negative tumors.      Because of lack of information related to the the factors affecting the choice of a     particular treatment strategy, as well as the optimization of the correct sequence of     treatments, the choice of the treatment for the advanced disease remains highly empirical and     may differ significantly among the different cancer centers.      The purpose of this study is the observation of a cohort of patients with metastatic     HER2-negative in terms of:        1. the choice of chemotherapy treatments starting from the first line of treatment;        2. factors that may influence these choices;        3. correlation among the characteristics of patients (age, menopausal status, etc.) and          type of adjuvant and metastatic treatment ;        4. clinical outcome (pattern of relapse, time from diagnosis, etc.);        5. evaluation of the adherence to the literature's recommendations for therapeutic          sequences in clinical practice.   "
70284|NCT02365818|"     To study the safety and efficacy of CG0070, an oncolytic virus expression GMCSF in high grade     non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.   "
70285|NCT02365805|"     Neoadjuvant chemotherapy (NAC) is increasingly used for early-stage operable breast cancer.     Response of breast cancer to NAC is correlated with survival: patients who obtain greatest     survival advantage are those who attain complete response of their primary tumor. BReast     Cancer 1 (BRCA1) plays a crucial role in DNA repair and associations between BRCA1 mRNA     expression and sensitivity to platinum and/or resistance to taxanes has been previously     documented. We propose a two-arm, randomized, multi-centre, open-label phase II study to     compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard FEC     chemotherapy, being pathological complete response the primary endpoint.   "
70286|NCT02365792|"     The ProDEms-trial focuses on nurses and ambulance drivers working in prehospital care, taking     care on the one hand of patients suffering from time-sensitive critical conditions like     STEMI, acute stroke or severe traumatic brain injury, and on the other hand of patients whose     lives are not in immediate danger but suffer from acute exacerbation of chronic conditions or     suffer from acute pain.      In the current study the investigators will use a multistage approach to test the hypothesis     whether the use of a CDSS in prehospital emergency care will: 1. Improve protocol adherence,     2. Reduce emergency department length of stay, 3. Improves diagnostic accuracy; without     impeding the workflow of the prehospital team or impairing patient safety.   "
70287|NCT02365779|"     High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with     an important mortality due to late diagnosis. However the prognosis is excellent in the early     stages of the disease. Recently it has been described a new serous carcinogenic sequence from     the fallopian tube with tubal precancerous lesions. Therefore the identification of these     early preinvasive lesions would be of great interest in the population with hereditary     predisposition for ovarian cancer (concept of oncofertility) and in the general population     (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for     benign disease).      The optical biopsy has been developed and validated in the detection of early precancerous     lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective     of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the     study of fallopian tubes during laparoscopy with correlation between the histopathological     and immunohistochemical analysis and the endomicroscopy image interpretation. The second     objective is to describe the optical biopsy pictures in order to state a classification.   "
70288|NCT02365766|"     This is a pre-surgical study involving subjects with muscle invasive bladder cancer, or     urothelial cancer, who are candidates for neoadjuvant therapy. It is is a two-part trial with     a one-arm phase Ib portion followed by a two-arm phase II portion. The study treatment is     stratified into two cohorts based on cisplatin eligibility.   "
70289|NCT02365753|"     A double-blinded randomized control study using a pulsed electromagnetic field therapy to     establish whether this device decreases patient pain and decreases narcotic use in women who     have undergone cesarean delivery.   "
80069|NCT02237846|"     Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once     per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect     in osteoarthritis (OA) patients.   "
70290|NCT02365740|"     This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients     (DM1) free of chronic complications in comparison with a group of healthy control subjects.     The investigators will also assess the relationship between GE and glucose control (HbA1c,     postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and     gastrointestinal symptoms.      In addition, in patients with delayed GE the investigators will investigate the effect of     tailored pre-prandial insulin bolus administered by means of insulin pump in reducing     postprandial glucose variability, evaluated through continuous glucose monitoring system.   "
70291|NCT02365727|"     Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block,     standard of care for this procedure, or Exparel alone for pain management after surgery. They     will also be asked to complete questionnaires before surgery, during their stay at the     hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain     and/or function levels, as well as the amount of pain medicine patients have used after     surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6     and 12 months after surgery.   "
70292|NCT02365714|"     This study will prospectively evaluate the technical feasibility, acute toxicity, late     effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast     Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL)     issues as they relate to treatment-related side effects and cosmetic results.   "
70293|NCT02365701|"     This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in     patients with Functional Dyspepsia as measured by change in maximum tolerated volume and     aggregate symptom score on the nutrient drink test.   "
70294|NCT02365688|"     The purpose of this study is to retrospectively evaluate the hemodynamic response to goal     directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy     is a standard of care after establishing a pre-incision baseline response to fluids.   "
70295|NCT02365675|"     The purpose of this study is to compare the efficacy of four dressings (covers) namely: gauze     with petrolatum , cellulose acetate with petrolatum , pure carboxymethylcellulose with silver     and nanocrystalline silver to improve the new growth of skin, reduce pain and itch in persons     suffering from pemphigus and pemphigoid.   "
70304|NCT02365558|"     The purpose of this study is to evaluate the effect of increased stomach pH on how much     evacetrapib is found in the blood stream and how long the body takes to get rid of it when     given to healthy participants. Information about any side effects that may occur will also be     collected.      There are two parts to the study. Participation in both parts will be required.      The study will last approximately 30 days, not including screening.   "
70305|NCT02364505|"     The aim of the project is to investigate the impact of a multiple sclerosis specific     telemedicine mindfulness-based Intervention on the quality of life of people with multiple     sclerosis and their caregivers.   "
70306|NCT02364492|"     The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained     following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses     of 30 µg, 100 µg or 300 µg IM every three weeks.   "
70307|NCT02364479|"     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy     and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein     injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary     purpose is to assess the different maintaining treatment programme in SpA patients with     controlled inflammation by Yisaipu®. And the second purpose is to assess the eficacy and     safety of Yisaipu® in axial SpAs. The trial will include 180 patients with stable NSAIDs     therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then at the     second stage the patients who achieve low disease activity (LDA, ASDAS<2.1) at 24th week will     be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of Yisaipu®     group and placebo group. And the blind stage will last for 24 weeks. Patients who complete     the 48-week therapy or achieve disease-flare criteria during the blind stage would finish the     study.   "
70308|NCT02364466|"     Prospective, observational cohort study of peripheral T cell lymphoma. Purpose is to     investigate the complication including febrile neutropenia in the era of pegylated G-CSF     prophylaxis.   "
70309|NCT02364453|"     The purpose of this study is to determine the effects of antihistamine (Clemastin) on     migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as     on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate     the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages     than previously investigated. As this has never been done before it is unknown how a lower     dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying     symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.      Our three hypotheses are:        1. Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of          migraine in migraine patients.        2. Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and          tryptase after PACAP38-infusion.        3. PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.   "
70310|NCT02364440|"     Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands.     Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained     pre-treatment and at 90 days post-treatment   "
70311|NCT02364427|"     Acute Kidney Injury is a condition where your kidneys suddenly stop working properly and     usually occurs if you are already unwell with an illness and can happen after having surgery.     Having an episode of acute kidney injury increases the risk of progression to chronic kidney     disease (CKD) later on and decreases long-term survival. It also has a major socioeconomic     impact with regards to admissions and length of hospital stay. There is currently no     universally accepted treatment or method of identifying patients that are at risk. The     investigators aim to measure arterial stiffness in patients prior to them undergoing cardiac     surgery to investigate whether this measurement is associated with an increased risk of     patients developing acute kidney injury after surgery. The investigators are planning to     measure arterial stiffness, and examine a blood sample, for kidney health-related levels to     determine whether there is an association between those patients who have stiff arterial     vessels and those patients who may develop acute kidney injury after surgery.   "
70312|NCT02364414|"     The purpose of this study is to compare the accuracy of measurements derived from a     commercially available direct intra-oral scanning system with those taken from plaster study     models, and to compare cost implications of both systems.      The investigators will test the hypotheses:        -  There is no systematic difference between measurements taken from the Trios scanner and          study models.        -  There is no difference in the cost of producing digital models.   "
70313|NCT02364401|"     The purpose of this study is to compare the efficacy of catheter ablation for atrial     fibrillation between contact force-guided and impedance-guided annotation using automated     annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly     assigned in the same number to two groups with impedance guided ablation and contact force     guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter,     Biosense Webster, Inc., Diamond Bar, CA).   "
70314|NCT02364388|"     Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to     concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and     B-mode imaging). This medical device has CE-marking and is approved for use in Europe and     other nations.      This is a post-market, non-randomized multi-center surveillance study.   "
70323|NCT02365480|"     This randomized, pilot phase I trial studies the side effects of berberine chloride in     treating patients with ulcerative colitis and who are in remission (a decrease in or     disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer.     Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention     is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or     coming back. The use of berberine chloride may keep colorectal cancer from forming in     patients with ulcerative colitis.   "
70372|NCT02364843|"     This is the 5th in a series of physiological studies to determine the amino acid requirements     of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine     requirements in infants when they are fed by parenterally (intravenously). Due to the new     requirements of Health Canada for preparation of parenteral solutions, the investigators are     starting the phase of the study that determines the enteral (oral) intake of threonine in 1 -     6 mo infants in the interim.   "
70315|NCT02363322|"     Background:      - Ebola is a viral infection that can spread quickly and causes life-threatening disease.     Right now there is an Ebola outbreak in many countries in West Africa. There are no approved     treatments for Ebola. But possible treatments are being developed. Researchers need to study     these treatments to see if they help people get better.      Objective:      - To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental     drugs to advanced Ebola care can reduce the risk of death.      Eligibility:      - People who have recently been diagnosed with Ebola, usually by a test called the Polymerase     Chain Reaction (PCR), and have been hospitalized in an isolation unit for treatment.      Design:        -  Participants will be randomly assigned to Group A or B. Both groups will get advanced          level care. One group will also get an experimental drug.        -  Participants may have blood tests. They may have another PCR test.        -  Researchers will try to learn how the participant got Ebola.        -  Participants put in the experimental drug group may start taking medicine within 24          hours of enrollment. It may be given by mouth or intravenously. Additional doses may be          needed.        -  Participants may have a series of timed blood tests over the first 24 to 48 hours after          they take the medicine.        -  Blood will be drawn frequently. Other body fluids (urine, stool, vaginal fluid, etc.)          may also be collected.        -  Participants will be followed for up to 60 days. They may be evaluated for any long-term          effects of the experimental treatment(s). They may be asked to return for 1 or more          outpatient visits.        -  For consenting participants, follow-up will be extended for up to one full year past Day          58 with contact/visits every 1-3 months to assess for a history of signs or symptoms          potentially consistent with late onset of virologic relapse syndrome.   "
70316|NCT02363309|"     Background:      - Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver tests. It is     closely linked to health problems like obesity and diabetes. Researchers want to use a breath     test to measure the metabolism of fatty acids and learn more about the causes of disease.     They will compare the results between people who do and do not have NAFLD. They will also     repeat the test in people with NAFLD after treatment to see improvement.      Objectives:      - To measure the metabolism of fatty acids and compare them between people who do and do not     have NAFLD, and people with NAFLD before and after treatment.      Eligibility:        -  People age 21 and older with NAFLD        -  Healthy volunteers        -  non-NAFLD metabolic syndrome      Design:        -  Participants will be screened with medical history, physical exam, and fasting blood          tests.        -  Participants will fast overnight.        -  Participants will sit in a comfortable chair. They will relax for 15 minutes. Then a          narrow plastic tube will be put under their nostrils. It will be connected to a breath          test device.        -  Participants will drink palmitate or acetate in a heated liquid meal (Ensure). Palmitate          is a fatty acid and acetate is a small molecule that is a building block for fatty          acids. Both palmitate and acetate are natural compounds that are in our body and our          food.        -  Participants will sit for 6 hours. They can read, watch television, work on a computer,          or other relaxed activity. The air they breathe out from their nose will be collected          and analyzed. They may take a bathroom break after 3 hours. They may drink water after 3          hours.        -  Participants will get a meal after the test.        -  Participants will have another visit at least 1 week later. They will repeat the test          with the other compound (acetate of palmitate).        -  Participants may be asked to repeat a test to study the result of a change like weight          loss or medicine. Thus, participation can last from 1 week to several years.   "
70317|NCT02363296|"     Background:      - Brain activity changes with changes in body temperature. Brain activity can be studied with     a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the     brain through the scalp using a cooling cap. They want to see if cooling changes the brain     and body s response to TMS.      Objectives:      - To look at the effects of cooling on the brain.      Eligibility:      - Right-handed adults age 18-50 who can abstain from caffeine and tobacco.      Design:        -  Participants will be screened with medical history and physical exam. They will be asked          about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They          may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie          on a table that slides in and out of a metal tube that takes pictures.        -  Participants will have 3 outpatient visits. The following procedures will occur at each          visit.        -  Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through          the cap. It will feel like an ice pack in a towel. Their core temperature will be          monitored. Their temperature will also be measured under their tongue and on scalp,          stomach, forearm, and calf.        -  Participants will have TMS before and after wearing the cap. A brief electrical current          will pass through a wire coil held on their scalp. Electrodes that detect muscle          movement will be placed on their hand. They will also have repetitive TMS, which uses          repeated magnetic pulses. Their wrist will also receive a shock.   "
70318|NCT02363283|"     This phase II trial studies how well glembatumumab vedotin works in treating patients with     middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the     body (metastatic) or has returned at or near the same place after a period of time during     which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink     the tumor by binding to tumor cells and delivering tumor-killing substances to them.   "
70319|NCT02365532|"     This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with     dofetilide-induced QTc prolongation.   "
70322|NCT02365493|"     The aim of this clinical trial is to determine whether a novel combination antibiotic     treatment (vancomycin/daptomycin + beta-lactam) is superior to the standard antibiotic     treatment (vancomycin/daptomycin) for hospitalised adults with Methicillin Resistant     Staphylococcus aureus bacteraemia. The hypothesis is that the addition of beta-lactam     antibiotics (these are antibiotics from the penicillin family) to the standard therapy will     lead to more efficient bacterial killing and hence lead to faster clearance of bacteria from     the blood stream and other areas of infection, thereby reducing the risk of the spread of     infection and death.      The study design is an investigator-initiated, multi-centre, open-label, randomised     controlled trial. This will include 440 participants diagnosed with Methicillin Resistant     Staphylococcus aureus bacteraemia recruited over a period of 4 years (July 2015 - June 2019)     from within Infectious Diseases inpatient units across 21 hospital sites including 18 from     within Australia and 3 located in Singapore. Participation will be voluntary and subject to     informed consent. The participants will be randomised 1:1 to either the standard therapy     group or combination therapy group. The combination therapy will include a treatment of     intravenous beta-lactam for the first 7 days of treatment, in addition to the standard     treatment (either vancomycin or daptomycin). The primary outcome measure will be     complication-free survival 90 days post randomisation.   "
70369|NCT02364882|"     This is a Phase 1, single center, open-label, within-subject dose-escalation study evaluating     the safety and pharmacokinetics of SST-6006 in healthy postmenopausal women. Three dose     levels of SST-6006 and a placebo regimen will be evaluated: 1 g (0 mg of sildenafil), 1 g (50     mg of sildenafil), 2 g (100 mg of sildenafil), and 4 g (200 mg of sildenafil). Doses will be     administered sequentially and will be separated by a 14-16 day washout period. All 3 dose     levels and the placebo will be applied both externally and internally.   "
70324|NCT02365467|"     The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA     Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the     device acutely and at the 30 day visit in the identified subject population. This study will     also evaluate the current instructions for use and may direct changes to the delivery and     deployment steps.      The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA     Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the     device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B     dissections.   "
70325|NCT02365454|"     A multicenter, prospective, open-label, non-randomized, interventional clinical study,     sponsored by Endospan Ltd. Patients will be followed-up for five years.   "
70326|NCT02365441|"     An open label randomised trial for adults with histologically confirmed measurable metastatic     GIST who have received no other treatment for metastatic disease. The study aims to determine     if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in     comparison to imatinib alone to warrant further evaluation as a first line treatment for     metastatic GIST.   "
70327|NCT02365428|"     Fewer pregnant women achieve recommendations for physical activity (PA) (30 minutes of     moderate PA 5 days of the week) as compared to non-pregnant women (15.8% to 26.1%     respectively), and PA participation declines as pregnancy progresses. The benefits of PA     during pregnancy are abundant to both the mother (e.g., reduced weight gain, lower risk of     gestational diabetes) and the fetus (e.g., decreased fat mass, improved stress tolerance).     Pregnancy represents a significant time in a woman's life in which she may be motivated to     change her health behaviors due to concerns for the healthy development of the fetus and a     quick return to pre-pregnancy weight. Hence, pregnancy represents a critical time to support     women in PA participation.      In our previous research, 94% of pregnant and postpartum women of varying socioeconomic     statuses reported using the Internet for pregnancy and PA information. Despite some women     increasing their PA participation as a result, most did not know if a website was reputable     or reliable (i.e. evidence-based). Studies have reported that most online health information     is unregulated and inaccurate. Further, women often receive inadequate PA information from     physicians who are constrained by time and lack of knowledge about PA. Therefore, directing     pregnant women to evidence-based websites via text messaging may provide a feasible approach     to improve PA participation. PA participation in pregnant women is an ongoing challenge that     warrants testing of innovative solutions.      The purpose of this study is to determine the feasibility of using mobile phone text     messaging to refer pregnant women to evidence-based websites for PA information to increase     PA levels.   "
70328|NCT02365415|"     This is a research study to assess whether an oral medication can benefit some patients being     treated for peripheral pulmonary stenosis (PPS), which is narrowing of the blood vessels that     send blood to the lungs (pulmonary arteries).      In the cardiac catheterization laboratory, the investigators treat PPS by dilating the     narrowed segments of pulmonary arteries using balloon catheters. Sometimes the investigators     also place stents which are mesh tubes that help keep the narrowed vessel open. Some stents     suffer from in-growth of tissue into the stents which causes recurrent obstructions inside     the stent (i.e. making the opening inside the mesh tube narrow again), so called in-stent     stenosis (ISS).      The purpose of this study is to use a medication that is approved for use in children (for a     different purpose) to decrease the amount of cell ingrowth inside the stents (i.e. decrease     the problematic in-stent stenosis). The medication is called rapamycin, also known as     sirolimus (trade name Rapamune). It has antiproliferative properties which means that it     slows down cell division which the investigators believe cause the recurrent narrowing inside     stents.      Rapamycin is a medicine that can be taken by mouth as a liquid or pill or via a feeding tube.     There will still be a need for interventions in the catheterization laboratory but the     investigators hope that by taking this medicine some children would need fewer     catheterizations in the future. Our early experiences with a few patients who have been     treated with rapamycin due to in-stent stenosis in the pulmonary arteries suggest that it may     be helpful.      In this study, patients and families who are interested in possibly trying this new approach     will be randomized to sirolimus or no sirolimus. The investigators will compare the     developement of ISS over time between these groups, in a hope to learn whether oral sirolimus     reduces ISS development.   "
70329|NCT02365402|"     The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients     obtain immune control to hepatitis B virus defined as sustained viral response after     treatment. However this target could not be get if patients keep HBV DNA positive during     interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir     will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha     2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of     sustained viral response after 48 weeks of treatment and 24 week follow up.   "
70575|NCT02361983|"     The aim of this study is to compare the success rate of lung isolation and time to accomplish     a correct placement of the device between anesthetists with experience in thoracic anesthesia     (defined as at least 4 years clinical practice experience as attending anesthetists in     thoracic) and residents in training in thoracic anesthesia.   "
70330|NCT02365389|"     A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the     conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in     the in-situ gel group as compared with 47.4 in the conventional gel group.The current study     aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus     twice-daily conventional MTZ vaginal gel in treatment of BV.   "
70331|NCT02365376|"     The objective of this protocol is to enable collection of biospecimens to facilitate current     and future multidisciplinary research in rare genetic disorders and medical conditions.   "
70332|NCT02365363|"     The objectives are to test the acute effects of different bagels containing pulse ingredients     on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood     glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours     following the exercise session. We hypothesize that consumption of bagels containing pulse     ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen     consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction     in lactate production during compared to the same exercise session following the ingestion of     a non-pulse food. We also hypothesize that consumption of bagels containing pulse ingredients     will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie     compensation, following a 60-minute aerobic exercise session compared to the same exercise     session following the ingestion of a non-pulse food.   "
70333|NCT02365350|"     The primary objective is to demonstrate superiority of follicle flushing with the STEINER-TAN     Needle® as compared to single lumen aspiration in terms of numbers of COCs retrieved.   "
70334|NCT02365337|"     The aim of this study is observing the relation between serum Vitamin D levels and     morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women     undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor     infertility. Individuals will be divided into 2 groups according to serum vitamin D levels as     normal or low , and the influence of those levels in morphokinetic parameters of embryos will     be identified.   "
70335|NCT02365324|"     The proposed integrated project will evaluate the effects of an evidence-based extension     education program, Family Fitness Program (FFP) grounded in Stages of Change Learning Theory     and guided by Social Cognitive Theory (SCT), with and without a peer-education mode of     delivery on balancing calories to manage body weight (BW), reducing certain foods and food     components, increasing selected foods and nutrients, building healthy eating patterns [i.e.,     fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010] and SCT     variables. Briefly, the 12-week program will target early adolescent children, ages 11-14     years, test a peer-education approach to behavioral change and will be delivered as an     after-school program in local middle schools in support of childhood obesity prevention. Data     will be collected at baseline (preintervention), after the 12-week program     (post-intervention) and 6 months after completion of the program (maintenance).   "
70336|NCT02365311|"     The investigators used transesophageal echocardiography (TEE) to assess the change of     pulmonary blood flow and bi-ventricular function during lung isolation. The investigators     hypothesized that changes in pulmonary venous flow with lung isolation may be related the     shunt fraction and oxygenation during one lung ventilation (OLV). The investigators also     observed the cardiac function during two lung ventilation (TLV) and OLV in supine and lateral     position by TEE.   "
70337|NCT02365298|"     In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel     materials and that this protein remains largely active and promotes reduced cytokine response     in an in vitro culture of human corneal epithelial cells. This study investigates whether     these data transfer to the in vivo situation.   "
70338|NCT02365285|"     The investigators will test the hypothesis that acute central acetylcholinesterase inhibition     will restore PNS activity and reduce oxidation in AAW compared to whites.   "
70339|NCT02365272|"     The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients     with severe sepsis and septic shock.   "
70340|NCT02365259|"     The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on     vitamin D production in persons with MS.   "
70341|NCT02365246|"     Removal of IgE through adsorption of IgE on a specially designed column after apheresis of     blood has the potential to improve the severity of atopic dermatitis.      In this study the investigators will treat patients with a severe form of Atopic dermatitis     not responding or having to much side effects to systemic imunosuppressive treatment with     this modality.   "
70342|NCT02365233|"     The primary objective of this trial is to measure changes in hepatic lipid content using     three common alternative therapeutic strategies to improve glycemic control in patients with     type 2 diabetes who are not controlled with metformin alone.   "
70343|NCT02365220|"     The purpose of this study is to investigate the placebo effect in a smartphone-based     training, ostensibly designed to improve mood and perceived stress by daily exposition to     either mock sound or color.   "
70344|NCT02365207|"     Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment     response) BCG intravesically followed by a cystectomy.   "
70345|NCT02365194|"     A pre-operative physical conditioning and weight loss intervention (prehabilitation) compared     to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40 kg/m2) at     a safety-net hospital results in a higher proportion of patients being hernia- and     complication-free 2 years after surgical consultation.   "
70346|NCT02365181|"     The control of perioperative pain is necessary to avoid worst surgical suites after shoulder     arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in     postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse     events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is     a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder     arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative     analgesia after shoulder arthroplasty.   "
70533|NCT02362529|"     The purpose of this study is to determine if translocator protein total distribution volume     (TSPO VT) is elevated in major depressive disorder that is not responding to medication and     if adding minocycline can affect TSPO VT. Many remain treatment resistant with common     antidepressant treatments and the investigators think it may be due to poor targeting of     brain pathologies.   "
70347|NCT02365168|"     Study hypothesis:      Some children and adolescents with fish allergy can tolerate eating some species of fish      Purpose of the study:      The purpose of this study is to determine to which degree fish allergic children and     adolescents can tolerate some species of fish and find the minimal eliciting allergen dose to     which only 10% of participants get allergic reaction.      Participants:      Participants are 40 patients recruited from children and adolescents outpatient clinics at     the University Hospital of North Norway with a history of fish allergy and sensibilisation of     one or more fish species with either positive specific IgE in serum or skin prick test.     Patients with sensibilisation to one or more fish species that never have eaten fish are also     recruited.      Method:        -  All participants undergo a clinical examination including lung function test with          spirometry before inclusion in the study.        -  All participants are tested for allergic sensibilisation with measure of specific IgE          against common food and inhalation allergens in addition to 10 different fish species.        -  All participants are challenged with cod, salmon, mackerel and placebo, disguised in a          chocolate mousse. The challenges are performed in randomized order with Double Blind          Placebo Controlled Food Challenge (DBPCFC) on 4 different challenge days with minimum 6          weeks in between each challenge day.        -  Participant with allergy to pollen will not be challenged during pollen season.        -  Test food is developed especially to this study in cooperation with The National          Institute of Food Research in Norway and The University of Manchester. The National          Institute of Food Research in Norway have produced a dried powder of cod, salmon and          mackerel. The Molecular Allergology group at Manchester Institute of Biotechnology, the          University of Manchester, have produced test kits based on chocolate mousse containing          low and high doses of the fish powders. The National Institute of Food Research have          measured protein content and microbiology in the fish powders. The Molecular Allergology          group have provided quality measurements of the final product and tested the disguise in          a sensoric test panel.        -  Participants with no allergic reaction to one or more of the blinded challenges undergo          open food challenge with larger doses of cooked fish than used in the DBPCFC, after the          randomization has been broken.   "
70348|NCT02365155|"     There is enough scientific evidence of the benefits detection of frailty in patients with     heart failure, which is an important prognostic factor. The usefulness of screening frailty     as flattering tool making diagnostic and therapeutic decisions in patients with heart failure     and now emerges in various recent studies. However, it is not found in the literature any     study on the potential effectiveness of a comprehensive intervention on the fragility that     includes the physical section (endurance, strength, flexibility and balance), nutritional,     hormonal (supplementation deficit D vitamin) and pharmacological (adjusted to clinical     guidelines according to requirements) in patients with heart failure after hospitalization     for cardiac decompensation, to improve survival and reduce cardiac decompensation and     hospital admissions resulting in a better quality of life for these patients. Therefore, the     investigators designed the following study.   "
70370|NCT02364869|"     This 12-week double-blind randomized controlled clinical trial aims to investigate the effect     of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic toxins     (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and the impact     of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and     inflammatory response.   "
70349|NCT02365142|"     Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological)     of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet     richa plasma (PRGF) in patients with knee osteoarthritis.      Patients and methods      Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19     patients for each group. The investigators compare the intraarticular injection of against     the administration of two different doses of mesenchymal stem cells with hialuronic acid     according to the following scheme:        1. Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7          days.        2. Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7          days and one with Mesenchimal stems cells. Intra-articular injection of 100 million          autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile          small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by          an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed          with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.      In addition the investigators assess the response to intra-articular infusion of CMM     analyzing the following parameters:        -  Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since          treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.        -  Radiographic (baseline and 12 months from treatment): Femorotibial space.        -  Radiographic using MRI (baseline and 12 months from treatment): by assessing the number          location of the lesions , cartilage thickness , signal intensity , subchondral bone          alteration , volume and WORMS and dGEMRIC protocols.   "
70350|NCT02365129|"     The energy burning capacity of brown adipose tissue makes it an attractive target for     anti-obesity therapies. Sympathetic nervous system (SNS) is the classical regulator of brown     adipose tissue; however, recent findings show a pool of novel brown adipose tissue activators     that sidestep the need for stimulating the SNS, including cardiac natriuretic peptides. Of     interest is that both SNS and non-SNS brown adipose tissue activators are sensitive to     physical exercise, which opens new horizons and opportunities to study the potential effect     of exercise-based therapeutic interventions. Moreover, a new protein released by     exercise-stimulated skeletal muscle, irisin, seems to play a key role in the browning program     of white adipose tissue. Most of the available evidence comes from animal studies, which is     sometimes difficult to infer to human physiology. The overall objective of the ACTIBATE     randomized controlled trial is to study the effect of long-term exercise training (6 months)     on brown adipose tissue activity and quantity (primary outcomes) in young overweight and     obese adults. The clinical significance of activating and recruiting brown adipose tissue on     resting metabolic rate and cardiometabolic profile in humans will be determined. The     investigators will also study at the molecular level the benefits of exercise on the     regulation pathways in two different tissues: white adipose tissue and skeletal muscle, as     well as identifying possible cross-talk between the exercising muscle and heart, and fat.     Information from exercise-induced signaling on brown adipose tissue, white adipose tissue and     skeletal muscle will help on identifying potential molecular therapeutic candidates.   "
70379|NCT02364752|"     The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other     circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels     in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and     other circulating biomarker levels, and performs imaging in participants with cardiac     dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy     participants, biomarker levels are elevated in participants with mild/moderate and severe     cardiac dysfunction.   "
70380|NCT02364739|"     Fertility knowledge and awareness is considered insufficient in women of reproductive age     from developed countries. The objective of this study is to evaluate if educational     interventions in oocyte donors increase on their level of fertility knowledge and awareness.   "
70576|NCT02361970|"     The purpose of the study is to evaluate the status and function of gamma delta T cells in     peripheral blood of sepsis patients.   "
70351|NCT02365116|"     Every year in the United States about 1 million people make a suicide attempt and more than     38,000 die by suicide. The risk of suicide is highest among individuals with mental illness     who have been hospitalized due to suicidal thoughts or behaviors, yet there are few     interventions known to reduce suicide risk in this population. This study will develop and     pilot test a peer mentorship intervention by which trained peer professionals will use their     own personal experience with recovery from mental illness to instill hope and belongingness     in high-risk patients and provide additional support to prevent future suicidal thoughts or     behaviors.      The specific aims of the study are to: (1) develop a peer mentorship intervention to reduce     suicide risk among patients psychiatrically hospitalized with suicidal ideation or following     a suicide attempt; (2) Conduct a randomized controlled pilot study to assess the     acceptability, feasibility, and fidelity of the peer mentorship intervention in preparation     for a larger efficacy trial; and (3) an exploratory aim will be to measure potential     mediators and moderators of intervention effectiveness in terms of belongingness,     burdensomeness, and hopelessness according to the interpersonal theory of suicide.   "
70352|NCT02365103|"     The purpose of this study is to investigate the inhibition effect of tea consumption on non     haem iron absorption with the use of an iron tracer. The study also aims to assess the effect     of time variability of tea consumption on non haem iron absorption from a typical western     breakfast.   "
70353|NCT02365090|"     1. To determine whether a binocular iPad game app is effective in improving visual acuity          and reducing interocular suppression in amblyopic children        2. To compare the amount of visual acuity improvement achieved with the binocular game app          to the amount achieved with patching (standard treatment for amblyopia)   "
70354|NCT02365077|"     This is a observation clinical trial. We are collecting the patients with glucocorticoid.     They were divided into the experiment group (with femur head necrosis) and control group     (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide     association study (GWAS). Our purpose is to find susceptibility loci for     glucocorticoid-induced femur head necrosis in the Chinese population.   "
70355|NCT02365064|"     The study will determine which of two different types of positive airway pressure (PAP     therapy) modes are more effective in reducing sleep breathing events in chronic insomnia     patients and in decreasing insomnia severity.   "
70356|NCT02365051|"     This community-based translational trial tests the value of a proven non-pharmacologic     intervention for older adults living with dementia and informal caregivers when this     intervention is incorporated into a publicly-funded home and community based service program.     Half the participants will receive customary publicly-funded services alone, and half will     receive customary services plus the proven non-pharmacologic intervention.   "
70357|NCT02365038|"     This is a multicenter randomized controlled pilot trial to investigate the feasibility of a     driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical     Network strategy (conventional strategy) in patients with acute respiratory distress syndrome     (ARDS).   "
70371|NCT02364856|"     This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its     variations after painful stimulations in children with cerebral palsy : acute procedural pain     (botulinum toxin injections), and recurrent pain (physiotherapy).   "
70358|NCT02365025|"     Amongst adolescents, there is a gap that widens with age between recommended sleep duration     and actual sleep time. Due to this gap, bodily and mental functions such as those related to     the metabolic and immune systems, performance, memory, school achievement and creative     ability can be harmed. Moreover, lack of sleep involves an increased risk of accidents and     injuries, behavior problems and reduced quality of life.      Biological factors that explain changes in sleep patterns include delays in the circadian     timing system and in the homeostatic system that regulate sleep and wakefulness. These     changes cause a growing and continuous delay in sleep phase during adolescence. In addition,     a number of environmental factors affect sleep patterns: variables such as early school start     time, increased homework assignments, after-school activities, lack of parental demand for     adequate sleep hours, and increased screen time, or use of electronic media, including     television, computer games, internet and cellular phones.      Based on the Parental Style model, the authoritative parenting style is characterized by     parents setting high demands on their children on the one hand and displaying high levels of     responsiveness to their children on the other. The authoritarian parenting style is     characterized by parents setting high demands on their children on the one hand yet     displaying low levels of responsiveness to their children on the other. The permissive     parenting style is characterized by parents setting low demands on their children and     displaying high levels of responsiveness to their children. In several investigations, the     authoritative parenting style has been shown to have a positive influence on child     development, academic achievement and psychosocial competency, and promoted healthy behaviors     in adolescents, such as good eating habits, increased physical activity and a decrease in     risky behaviors such as smoking, alcohol abuse, extreme diets and early sexual behavior.      The Conceptual Model views parents as the sole agents of change in their children's life, and     focuses on the power of personal example, environmental changes and promotion of the     authoritative parental style. The main aim of this research is to evaluate the effectiveness     of an intervention program that deals with increasing parents' awareness of the changes that     characterize adolescents and encourages the authoritative parental style based on the     Parenting Style Model.   "
70359|NCT02365012|"     This study will evaluate whether treatment with the α1-agonist, midodrine, reduces subjective     orthostatic lightheadedness as measured by the Non-Motor Symptoms Scale for Parkinson's     Disease (NMSS) questionnaire, in patients with (positive control group, OH) or without     documented orthostatic hypotension(orthostatic intolerance, OI). It will also demonstrate the     effect of treatment with an α1-agonist, midodrine, on beat-to-beat blood pressure and heart     rate response during Valsalva maneuver (measured by Continuous Non-invasive Arterial     Pressure, CNAP) in patients with OI or OH and evaluate the relationship to symptom     improvement.   "
70360|NCT02364999|"     This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial     evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin     versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients     with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.   "
70381|NCT02364726|"     The purpose of this study is to find out the effects of acupuncture on reducing nerve damage.      Acupuncture is a medical technique of inserting very thin needles into the energy points on     the body with the aim to restore health and well-being. It has been used widely to treat     pain, such as lower back pain and joint pain. In this study the investigators will assess if     acupuncture can be used to ease the pain, tingling and numbness that may be caused by     chemotherapy and improve quality of life during chemotherapy.   "
70382|NCT02364713|"     This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal     sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in     treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has     been changed in a certain way, may be able to kill tumor cells without damaging normal cells.   "
70361|NCT02364986|"     There are two standard and a few second line treatments for RRMS. Since the disease cannot be     cured by these existing treatments and all treatment options have significant limitations,     there is the need to develop new treatment strategies to improve therapy of patients with     RRMS. We developed a RIG-I ligand as a new therapeutic strategy for patients with MS. The     RIG-I ligand functions partially via induction of Interferon beta (IFN-b), but has advantages     over therapy with recombinant IFN-b. Identification of suitable biomarkers to monitor     treatment with RIG-I ligand and to guide the dose steps would help to increase the safety of     the volunteers in the early clinical trials with RIG-I ligand.      The RESI study is designed to analyse immune readouts and potential biomarkers such as type I     IFN levels, type I IFN dependent immune activation and miRNA expression following Rebif or     Avonex (Interferon beta 1a) application. Rebif is applied s.c. at a dose of 44 µg three times     a week (on day 1,3,5 and 8), and Avonex i.m. at a dose of 30µg once a week (on day 1 and 8),     as they are routinely used in RRMS-therapy. The immune readouts are assessed on day 1, 3, 5     and 8 immediately before application of Rebif/Avonex and on day 1 and 8 at 1 / 6 / 12 /24 hrs     after Rebif/Avonex application by analysing blood samples. Since studies of the RIG-I ligand     will start in healthy volunteers and will be continued in MS patients we need data from both     populations since they could show significant differences in response to IFN-b. Thus, the     RESI study includes healthy volunteers, RRMS-patients already under Rebif/Avonex treatment,     and RRMS-patients who have to yet started a therapy with Rebif/Avonex.   "
70362|NCT02364973|"     The main purpose of the present study is to examine the diagnostic performance of combined     PET-MRI in detecting colonic and small bowel wall inflammatory processes caused by ulcerative     colitis and Crohn's disease.   "
70363|NCT02364960|"     The purpose of this study is to create a registry to evaluate the use of intra-operative     radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given     intra-operatively as a single fraction after breast conserving surgery,   "
70364|NCT02364947|"     The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in     patients with alcohol dependence will be evaluated in a multicenter, randomized,     double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of     nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol     consumption.   "
70365|NCT02364934|"     To explore and compare the effects of propoful, sevoflurane, and a combination of both on the     pharmacokinetics and pharmacodynamics of rocuronium.      To discover and confirm sex differences on the pharmacokinetics and pharmacodynamics of     rocuronium.      To evaluate and examine aged people on the pharmacokinetics and pharmacodynamics of     rocuronium.   "
70366|NCT02364921|"     The purpose of this study is to evaluate the effectiveness of a multilayer compression     bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in     patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.   "
70367|NCT02364908|"     This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized,     multicenter study to evaluate the non compliance to antimalarials in patients with systemic     lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits     consist in obtaining blood sample, performing a clinical examination and filling in a     questionnaire (Quality Of Life, Coping...).      The goal for the noncompliants patients is to guide them towards the therapeutic education     with professionals (nurses and physicians).   "
70368|NCT02364895|"     This study evaluates effectiveness of mailed invitations for colorectal cancer screening     among screen-eligible Ontarians who are due for screening. The study will evaluate the     effectiveness of mailed invitations in general (compared to no invitation) but will also     determine if new invitation letters (2 letters for male, 1 letter for females) are more     effective than current invitation letters used by the ColonCancerCheck program.   "
70373|NCT02364830|"     Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but     Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of     Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and     bloating.   "
70374|NCT02364817|"     Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD)     was frequent among patients with alcohol-dependence. However, no investigation has ever     addressed whether ADHD may impact the drinking outcome.      Moreover, most of the different aforementioned studies assessed ADHD using the ADHD     self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited diagnostic     value, and the overrepresentation of high-score ASRS among patients with alcohol-dependence     could be in part due to differential diagnoses such as antisocial or borderline personality     disorders, executive function impairments, or isolated impulsiveness.      The study aims to evaluate ADHD: Gaps between patients with Alcohol Dependence and Impact on     early Relapse (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the end     of a residential detoxification program. They are assessed for ADHD using the ASRS, but also     with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults (DIVA     2.0). Potential differential diagnoses are screened during the baseline visit. The patients     are followed-up during the 12 first post-detox weeks, through a standardized psychosocial     treatment. ASRS is re-performed at the end of the follow-up.   "
70375|NCT02364804|"     The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the     combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).   "
70376|NCT02364791|"     The purpose of this study is to explore whether the addition of Hemopatch to standard care     can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in     thoracic lung surgery patients at high risk for prolonged air leaks.   "
70377|NCT02364778|"     This is a prospective study to analyze the outcome of provisional main vessel stenting on     side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain     optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional     main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of     side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina     shift and plaque shift will be also be performed.   "
70378|NCT02364765|"     The purpose of the present study was to compare some hematologic parameters and operation     time in patients who underwent esthetic bimaxillary surgery under hypotensive anesthesia.   "
70384|NCT02364687|"     Detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart     conditions. Magnetic resonance imaging (MRI) can assess scarred heart muscle but it is time     consuming, contraindicated for some patients and not tolerated by others. Computed tomography     (CT) imaging has the potential to provide a rapid comprehensive assessment of the heart. This     study will assess CT imaging of the heart muscle of patients who have previously undergone     MRI of their heart. Using a state of the art CT scanner the investigators will develop a low     radiation dose protocol to identify scarred heart muscle. The investigators will use and     develop software techniques to analyse these images. This will enable us to develop a new way     to identify and measure scarred heart muscle that will benefit patients with heart disease.   "
70385|NCT02364674|"     The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early     stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust     and automated segmentation algorithms will be developed for these parameters, focusing on     quantitative computed tomography (CT) image analyses to provide the physician a more     sensitive diagnostics tool. The evolution of BOS over time will be monitored using non-rigid     image registration methods.   "
70386|NCT02364661|"     Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus     infects the liver and previous studies, done in tissue culture and in animals, have shown     that viral replication is affected by metabolic changes occurring in the liver. Specifically,     starvation induces HBV gene expression and replication, in parallel to the activation of the     gluconeogenesis response, and feeding attenuates viral activity. In this study we are going     to recruit HBV patients with detectable viremia and analyze their viral load after an over     night starvation versus after a morning meal. Our hypothesis is that following an over-night     starvation viral load will be higher than that in the fed state.   "
70404|NCT02364284|"     Reporting patterns and results of initial antibiotic treatment in patients with complicated     urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial     pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study   "
70388|NCT02364635|"     PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose,     Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects      Objective:        -  To assess the safety and tolerability of single ascending oral doses of icosabutate in          healthy subjects        -  To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects   "
70389|NCT02364622|"     The purpose of this study is to determine whether using the flexible Trachway(R) intubating     stylet could facilitate and promote the accurate placement of double-lumen endobronchial     tube.   "
70390|NCT02364609|"     This phase I/Ib trial studies the side effects and best dose of pembrolizumab when given     together with afatinib dimaleate in treating patients with non-small cell lung cancer that     has spread to other places in the body and usually cannot be cured or controlled with     treatment, or has come back and does not respond to erlotinib hydrochloride. Monoclonal     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and     spread. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving pembrolizumab and afatinib dimaleate together may be an     effective treatment for non-small cell lung cancer.   "
70391|NCT02364596|"     The purpose of this study is to evaluate the safety and immunogenicity of a single     vaccination of an investigational vaccine against Staphylococcus aureus (SA4Ag) in healthy     adults aged 18 to <65 years.   "
70392|NCT02364583|"     This study specifically seeks to provide data on the safety, tolerability and pilot efficacy     of short course, high dose primaquine treatment in Papua New Guinean children aged 5-10     years, in a cross-sectional study design. Community screened asymptomatic cases and/or cases     of clinically diagnosed malaria admitted to the out-patient units of the health center, will     be screened for Glucose-6-phosphate dehydrogenase deficiency (G6PD) and malaria illness by     rapid diagnostic test and P. vivax infection confirmed by light microscopy. Following     treatment with artemether-lumefantrine (Coartem), G6PD normal children will be enrolled into     the study and followed for 2 months. Primaquine treatment will be allocated to study     participants in a step-wise design; firstly receiving the current 14 day treatment regimen of     0.5 mg/kg total dose (n=40); secondly, a 7 day treatment regimen receiving a total dose of     1.0 mg/kg/day; then thirdly, receive 1.0 mg/kg twice daily dose (bd) for a total of 3.5 days,     should the 7 day treatment prove to be safe and well tolerated. In addition to this     dose-escalation study, the pharmacokinetic profiles of single doses of 0.5 mg/kg and 1.0     mg/kg will be determined using an intensive sampling protocol, in children aged 5-10 years.     The pharmacokinetic profiles obtained by this sub-study will be essential for modeling the     population pharmacokinetic data obtained from the dose-escalation study. As there is     currently no data on the safety, tolerability and efficacy of primaquine in children, the     present study will validate previous observation and contribute to the knowledge of     primaquine as a treatment for liver stages of Plasmodium vivax infection.   "
70393|NCT02364570|"     Cardiovascular disease (CVD) is largely a lifestyle-related condition that is the #1 killer     of adults in the United States. Our work is aimed at understanding how short-term increases     in blood sugar, like those that accompany eating a meal, affect blood vessel function and the     risk of CVD. This research is aimed at understanding how meals composed of eggs affect     short-term increases in blood sugar from eating, which are connected with increased risk of     CVD. In particular, the investigators are trying to identify a specific meal composed of     either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood sugar     brought on by meals that consist of majority carbohydrate. At the same time, the     investigators are trying to explore the protective affects that eggs may have on blood vessel     function and the reduction of CVD risk.   "
70461|NCT02363530|"     This randomized controlled subject- and examiner-masked study comprised patients scheduled     for cataract surgery.The patients will be randomly assigned to receive either balanced salt     solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject     should undertake examination including - rupture time (TBUT), height of the river of tears,     fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and     self-conscious symptom assessment questionnaire for assessment.   "
80070|NCT02237833|"     The purpose of this study is to reveal if higher doses of vasopressors in septic shock     patients correlates with cerebral vasoconstriction and lower cerebral oximetry.   "
70394|NCT02364557|"     This randomized phase II/III trial studies how well standard of care therapy with     stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy     alone in treating patients with breast cancer that has spread to one or two locations in the     body (limited metastatic) that are previously untreated. Standard of care therapy comprising     chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of     tumor cells. Radiation therapy and/or surgery is usually only given with standard of care     therapy to relieve pain; however, in patients with limited metastatic breast cancer,     stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to     send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be     able to effectively remove the metastatic tumor cells. It is not yet known whether standard     of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating     limited metastatic breast cancer.   "
70395|NCT02364544|"     The goal of the Improving Care and Reducing Cost (ICRC) Program, is to improve disease     management and the overall process of care in treating the chronic illness schizophrenia in     order to reduce ER visits and hospital days while providing better care, better health and     increased patient satisfaction. This will be done by fostering innovation in the use of     technology and by training and deploying a new cadre of personnel in the behavioral health     field: Mental Health/Health Technology (MH/HT) Case Managers.   "
70396|NCT02364531|"     The purpose of this study is to temporally evaluate the impact of abiraterone acetate     (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the     chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population. Safety     data, levels of health care resource utilization associated with abiraterone acetate (ZYTIGA)     therapy will also be prospectively collected and analyzed.   "
70414|NCT02364154|"     The hypothesis of the present study is that metabolic phenotyping of blood plasma allows to     (i) discriminate between colorectal cancer patients and control subjects and (ii) identify     new biomarkers for colorectal cancer. In order to test this hypothesis, the investigators     will apply proton nuclear magnetic resonance (1H-NMR) spectroscopy to perform metabolic     phenotyping of blood plasma in 50 colorectal cancer patients and 50 control subjects.     Multivariate statistics will be performed to assess the discriminative power of the applied     methodology in distinguishing between both groups and to identify metabolites with potential     as biomarkers for colorectal cancer.   "
70511|NCT02362828|"     The aims of EPiMAP Obstetrics are:        -  to identify risk factors for failure of epidural blood patch in the obstetric population          for management of post dural puncture headache.        -  to describe European practices in the management of accidental dural puncture in the          Obstetric population.   "
70397|NCT02364518|"     The purpose of this study is to assess the safety and effectiveness of TranQuillTM Sling (a     suture or thread used in surgery that is knotless) in snoreplasty (surgery procedure) for the     treatment of snoring and mild OSA in adult subjects. The TranQuill Sling Snoreplasty (QSS) is     a procedure where the suture will be inserted into the soft palate tissues for the treatment     of snoring and/or mild obstructive sleep apnea. Soft palate tissues are tissues in the back     of the roof of the mouth.      The research results will be used to provide data on feasibility (strengths and weaknesses),     safety, performance, and effectiveness data for the Surgical Specialties, Inc as a therapy     for snoring and/or mild obstructive sleep apnea. The TranQuillTM Sling is approved by the     U.S. Food and Drug Administration (FDA). The TranQuillTM Sling is used in all types of     surgery that involved deep tissues in the body.      The investigator in charge of the study is Dr. Boyd Gillespie. MUSC and Dr. Gillespie receive     financial support from Surgical Specialties, Inc. to conduct the study. MUSC is the only     place that this study will be conducted. For this research study the investigators plan to     enroll a total of up to 20 subjects at the Medical University of South Carolina.   "
70398|NCT02364362|"     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and     Flt3. Phase I study has shown that the toxicity is manageable.      This study assessed the safety and maximum tolerated dose of continuous daily treatment with     Famitinib plus docetaxel (60 mg/m^2, every 3 weeks) in patients with Advanced Non-squamous     and Non-Small Cell Lung Cancer (NSCLC) to determine the recommended dose for the Phase II     trial.   "
70399|NCT02364349|"     This double-blinded randomized clinical trial investigates any differences in allergic     responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).   "
70400|NCT02364336|"     Background:      - Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but     the virus can be controlled with the use of antiviral medicines,. Researchers think that     adding a second antiviral medicine might help.      Objective:      - To understand how peginterferon might help treat people with chronic hepatitis B. Also, to     see if peginterferon is safe to use with other antiviral medications.      Eligibility:      - Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral     medicines for hepatitis B for at least 4 years.      Design:        -  Participants will be screened with physical exam and medical history. They will complete          health questionnaires about their levels of fatigue and pain. They will have blood and          urine tests. They may have an eye exam.        -  Participants also will have a Fibroscan. A test to measure how stiff your liver is.        -  Eligible participants will have a liver biopsy. Blood will be drawn.        -  Participants will be admitted to the NIH Clinical Center. They will be injected with the          study drug. Then they will have a second liver biopsy. They will be discharged 24 hours          later.        -  Participants will give themselves study drug injections under the skin weekly for 24          weeks.        -  Participants will have 5 clinic visits during the 24-week treatment period. Then they          will have follow-up visits every 12 weeks for 48 weeks.        -  During visits, participants may have a physical exam and medical history. They may have          blood and urine tests. They may have a Fibroscan and complete questionnaires. At the          final visit, they will also have a Fibroscan.   "
70462|NCT02363517|"     This study will investigate the feasibility of treating people who inject drugs (PWID) with     hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy     combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a     social network-based approach to reduce HCV incidence among PWID.   "
70505|NCT02362906|"     The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine     for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.   "
70401|NCT02364323|"     The risk of diabetic kidney complications includes non-modifiable risk factors such as     genetic predictors, as well as modifiable risk factors such as hyperglycaemia, hypertension,     hyperlipidaemia and proteinuria. Genetic testing for personalized medicine is increasing in     popularity, though evidence that genetic testing can empower patients to modify behaviour and     reduce clinical risk remains lacking. In this project, the investigators aim to utilize a     personalized risk counseling with genetic testing to evaluate its impact on risk factor     control in diabetic patients. The investigators hypothesize that knowledge of genetic +/-     clinical risk will empower patients and lead to improvement in the number of treatment     targets achieved. The investigators will recruit 400 patients with diabetes. All subjects     will undergo a comprehensive assessment of the risk of diabetic complications based on     clinical risk factors. Half of the patients will be randomized to receive additional genetic     testing of a panel of genetic markers proven to predict renal complications in our     population: ACE I/D, aldose reductase (CA)n and PRKCB1 gene polymorphisms. The results of     personalized risk assessment will be communicated by a health counsellor in the intervention     arm. The impact of testing and patient knowledge of the result of genetic testing on     achievement of treatment targets (A1c, BP, LDL-cholesterol, TG, use of ACEI/ARB) and patient     behavior will be evaluated after 12 months. The other arm will receive results of the genetic     testing at the completion of the study period. The study will help towards developing a     strategy to empower patients through structured and personalized risk assessment will provide     a novel approach to identify high-risk subjects for early intensive management, and may lead     to reduction in long-term complications.   "
70402|NCT02364310|"     Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation     with Barostim NeoTM compared to usual care in patients with resistant hypertension     (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long     modeling.   "
70403|NCT02364297|"     In the last years, important advances have been done in the treatment and prevention of     fundal variceal bleeding in patients with cirrhosis. Experts agree that the combination of     pharmacological and endoscopic therapy (with tissue adhesives) should be the first line     therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2     gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic     shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent     variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy     and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in esophageal     variceal bleeding showed that an early TIPS, performed during the first 72h after patient     admission resulted in a significant decrease in failure to control bleeding and early and     late rebleeding. Moreover, survival was also significantly increased as well as other     portal-hypertension related complications (ascites, spontaneous bacterial peritonitis,     hepatorenal syndrome, etc).      The present study is directed at comparing the outcome of patients with acute bleeding from     fundal varices (IGV1 or GOV2) treated by standard therapy (vasoactive drugs + endoscopic     injection of tissue adhesives) with or without early TIPS (performed during the first 1-5     days after admission). Main end-point will be survival free of variceal rebleeding at 1 year     from inclusion.   "
70405|NCT02364271|"     The investigators hypothesize that coronary artery calcium score (CACS), heart-type fatty     acid binding protein (H-FABP) concentration, high-sensitive troponin t (hs-cTnT)     concentration and Thrombolysis in Myocardial Infarction (TIMI) score positively correlate     with the rate of the major adverse cardiac events (MACE) at 30 days and 6 months in patients     presenting to the ED with suspected acute coronary syndrome (ACS).      The aims of the present study in patients with chest pain of uncertain cardiac cause and a     non-ischaemic initial electrocardiogram (ECG) presenting to the ED are        1. To investigate whether there is any correlation between CACS, H-FABP concentration,          hs-cTnT concentration and modified TIMI score with the MACE rate at 30 days and 6          months;        2. To evaluate the predictive values of CACS, H-FABP, hs-cTnT, modified TIMI score and          various combinations.      Study design and participants This prospective observational study was conducted in the     Prince of Wales Hospital in Hong Kong.      Chest pain adult patients suspected with acute coronary syndrome were recruited.     Point-of-care H-FABP and hs-cTnT tests, TIMI score and CT scan for coronary calcium score     were performed on study subjects. Patients were followed-up at 30-day and 6 months for the     occurrence of major adverse cardiac events.      In 2014, a modified HEART score incorporating hs-cTnT was included as one of the predictors     under study alongside with modified TIMI score, FABP and CACS. The HEART score was completed     retrospectively.   "
70406|NCT02364258|"     This will be a single center, open label, randomized, cross-over study in patients with     dyslipidemia comparing the pharmacokinetics of rosuvastatin and atorvastatin in patients with     greater than or equal to one variant allele in the SLCO1B1 gene (-11187 and/or c.521) to     patients with the wild-type/wild-type genotype.      The studies goal is to establish the role of genetic variation and development in key     transporters on the dose-exposure relationship of two commonly used statin drugs in children.     This study is the first step in a series of investigations aimed to determining the     mechanisms behind variations in physiologic response, clinical efficacy and significant     adverse effect risk that surround the statin drugs in children and adolescents.   "
70407|NCT02364245|"     The purpose of this study is to design and evaluation the feasibility, effects of     Kinect-based Computer Games as Upper Extremity Training Tool in Children with Cerebral Palsy.   "
70408|NCT02364232|"     The purpose of this study was to compare the treatment effects of home-based or clinic-based     bilateral training with and without mirror feedback programon on physiological markers,     sensorimotor, cognition, daily functions, and participation among patients with chronic     stroke.   "
70409|NCT02364219|"     The primary purpose of this study is to determine whether a prewarming period of at least 30     minutes during induction of general and combined epidural anesthesia reduces the core     temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal     surgery. In addition the effect of prewarming on intra and postoperative body core     temperature will be evaluated.   "
70526|NCT02362620|"     Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer     Treated With doceTaxel and Cabazitaxel (PROSTAC).   "
70527|NCT02362607|"     The investigators aim to assess whether using integrated diabetes management protocol using     smartphone would increase glucose control among diabetes patients.   "
70410|NCT02364206|"     Glioblastomas are extremely resistant to treatment, including radiotherapy and/or     chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways     involved in the regulation of normal cell proliferation, survival and differentiation.     Activation of p38 MAPK has been associated with a poor prognosis among patients with     glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by     tumor cell to environmental stress such as radiation or chemotherapy.      LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its     cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate     to target malignant glioma resistance to the gold standard treatment combining radiation and     TMZ by acting on both tumor and stromal cells.      The primary objectives of this study were to determine the recommended dose of LY2228820 in     combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to     estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820     when administered at the recommended dose in combination with radiotherapy and concomitant     TMZ (phase II)   "
70411|NCT02364193|"     Heart failure (HF) is a major health problem, which is characterized by reduced cardiac     function leading to pulmonary congestion. Most episodes of acute HF requiring unplanned     hospitalization are due to pulmonary congestion. There is an urgent clinical need for     quantitative, reproducible, minimally invasive, and noninvasive methods to assess thoracic     fluid status. The potential value of dynamic contrast-enhanced magnetic resonance imaging     (DCE-MRI) to this end has been suggested and demonstrated in-vitro. In this study the     investigators aim to compare intra-thoracic fluid volume assessed by DCE- MRI using bolus     kinetic parameters of the indicator dilution theory and bioimpedance spectroscopy (BIS).      Primary objectives: This study evaluates the correlation between change in BIS and change in     bolus kinetic parameters in response to a fluid challenge.      Secondary objectives: The sensitivity of the bolus kinetic parameters to fluid challenges and     the normal range DCE-MRI bolus kinetic parameters is evaluated in healthy subjects.      Study design: Prospective nonrandomized pilot study.      Study population: Healthy volunteers.      Intervention: The subjects will receive an intra-venous injection of gadolinium, a MRI     contrast agent. External pressure will be applied by means of a leg-compression device in     order to induce a rapid increase of the preload by blood auto-transfusion.      Main study parameters: Pulmonary transit time (PTT), skewness of the indicator dilution curve     which is a measure of trans-pulmonary dilution, intrathoracic blood volume (ITBV), changes in     bolus kinetic parameters, and thoracic impedance in response to fluid challenges. The     correlation between changes in bolus kinetic parameters and thoracic impedance in response to     fluid challenges.   "
70412|NCT02364180|"     We intend to measure evoked EMG at two sites in subjects who are chronically taking     pyridostigmine.   "
70413|NCT02364167|"     The study entitled Acupuncture vs. placebo acupuncture and vs. standard therapy for pain     control after elective caesarian section - a randomized controlled trial aims to investigate     whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as     compared to placebo and standard therapy in patients after after elective caesarian section     (CS) in the period from January 2015 to May 2016.      For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia     will be recruited according to eligibility criteria. 120 patients will be randomized either     to verum or placebo acupuncture, 60 patients will be included in non-randomized standard     therapy arm. The outcome measures are: postoperative analgesic requirement, pain intensity,     incidence of side effects and physiological parameters.   "
70415|NCT02364141|"     The aim of this study was to evaluate the long-term effects of the task-specific training     with trunk restraint comparing to the free one in post-stroke reaching movements. Twenty     hemiparetic chronic stroke patients were selected and randomized into two training groups:     Trunk restraint group - TRG (reaching training with trunk restraint) and Trunk free group -     TFG (unrestraint reaching). Twenty sessions with forty-five minutes of training were     accomplished. The subjects were evaluated in pre-treatment (PRE), post-treatment (POST) and     three months after the completed training (RET). The measures administered were the Modified     Ashworth Scale, Barthel Index, Fugl-Meyer Scale and kinematic analysis (movement trajectory,     velocity, angles).   "
70416|NCT02364128|"     At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical     treatments including drugs and behavior modification have proven ineffective in producing     significant and lasting weight loss in this group. While bariatric surgery is extremely     effective for most patients, it also carries risks for both short and long-term     complications. There are currently four different types of bariatric surgery available and     the risks and benefits of these procedures vary widely and are strongly affected by patient     and clinical characteristics.      Decision making under these circumstances should reflect informed patient's values and     preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more     often driven by the beliefs and experiences of the bariatric surgeon that a patient happens     to see. Variability in the type of surgery recommended to patients likely results from some     combination of surgeons' subjective opinions and personal experiences with regard to the     risks and benefits of the treatment options and delegated decision making on the part of     patients.      The goals of this research proposal are to develop, implement, and evaluate an informed     decision support tool for treatment of morbid obesity. This project will be conducted within     the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide     clinical registry and quality improvement program that has the participation of virtually     every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes     externally audited clinical data for more than 35,000 consecutive bariatric surgery patients.     MBSC outcome measures include complications occurring within 30 days as well as weight loss,     comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric     surgery.   "
70417|NCT02364115|"     The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in     patients with bone metastatic disease.   "
70418|NCT02364102|"     The investigators aim to study whether hypothyroidism negatively affects Brown adipose tissue     (BAT) function in humans and whether BAT function can be restored to normal by thyroid     hormone supplementation.   "
70419|NCT02364089|"     The general objective is to evaluate the consequences of surgical removal of SCSI on     hypertension and cardiovascular risk factors in order to determine on an evidence-based basis     if surgical excision of SCSI is preferable to an intensive medical regimen in patients with     hypertension.   "
70420|NCT02364076|"     This is a non-randomized clinical trial in patients with thymic carcinomas who failed prior     systemic therapy. All subjects will receive MK-3475 treatment intravenously once every three     weeks until unacceptable toxicity, death, progressive disease or withdrawal.   "
70421|NCT02364063|"     This study evaluates the effectiveness of a voiding reeducation program as treatment for     incontinence in children with a brain injury.   "
70423|NCT02364037|"     The investigators study is testing models of contraceptive care that were developed as part     of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women     designed to: 1) promote the use of long-acting reversible contraceptive (LARC) methods which     include interuterine devices (IUD) and subdermal implants; 2) remove financial barriers to     contraception; 3) evaluate continuation of and satisfaction with reversible methods; and 4)     reduce unintended pregnancies in the St. Louis region. CHOICE demonstrated that interventions     such as comprehensive contraceptive counseling, increased access, and removal of financial     barriers increase the uptake of LARC methods and reduce unintended pregnancy. The     investigators objective is to determine whether the CHOICE model of contraceptive care can be     equally successful in the real world of community clinics.   "
70424|NCT02364024|"     The purpose of this study is to confirm that linear quantification of CD3+ cells is a     prognostic biomarker in localized colorectal carcinomas.   "
70425|NCT02364011|"     The purpose of this investigation is to determine both patient-reported and performance-based     outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different     surgical total knee prostheses in individuals following TKA. Change scores will be determined     based on patient-reported outcomes, kinematic/kinetic data, knee extension strength/power,     static/dynamic balance control, mobility measures and functional performance testing during     functional tasks (i.e. walking, ascending/descending stairs, sit-to-stand). After evaluating     the pattern of change in lower-extremity function, the investigators will be better prepared     to address residual functional impairments and prognostic factors linked to maximal recovery     over two years.   "
70426|NCT02363998|"     The purpose of this Phase 3 open-label treatment study is to evaluate the safety and     effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute     withdrawal from any opioid, including methadone and buprenorphine. This study will take place     in a variety of clinical scenarios, both in-clinic and outpatient settings.   "
70448|NCT02363699|"     Ineffective treatment of postoperative pain may cause organic damage and chronic pain.     Nevertheless, opioids, the leading drugs used for this purpose, present side effects that     sometimes restrict their usability. In a multimodal context, new postoperative analgesia     techniques have been developed focusing in the reduction of opioid use and their adverse     effects, as well as postoperative chronic pain prevention. In this background, continuous     intravenous infusion of lidocaine during perioperative period has shown to be promising. This     trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus and     length of hospital stay and IL-1, IL-6, IL-10, α TNF and γ IFN levels in patients undergoing     to laparoscopic cholecystectomies who received intravenous lidocaine in comparison to a     control group. Intravenous lidocaine in the perioperative period of laparoscopic     cholecystectomies was not able to reduce postoperative pain, opioid consumption, and duration     of ileus or length of hospital stay. However, its anti-inflammatory effect was evidenced by     the significant changes in the studied cytokines.   "
70449|NCT02363686|"     The purpose of this study is to learn more about problems with swallowing that could develop     in patients who are very sick and need a machine to help them breathe.   "
70427|NCT02363985|"     The combination of infectious diseases and malnutrition is the most prevalent, preventable     public health problem in the world, responsible for millions of deaths annually, particularly     in infants and children. Approximately 13 million children die each year in developing     countries from infectious diseases, with the majority of these deaths related to     malnutrition. The relationship between infections and malnutrition is synergistic, each     further compromising the outcome of the other. Malnutrition compromises natural immunity     leading to increased susceptibility to infections, more frequent and prolonged disease     episodes, and increased severity of disease. Likewise, infections can aggravate or     precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption,     nutrient loss or increased metabolic needs. Another issue is that infections (as well as     overweight and obesity status) affect nutritional biomarkers making it difficult to assess     the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A     deficiency is defined to be of severe public health importance if 20% or more of a defined     population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating     concentrations of serum retinol are reduced by infections and in such situations serum     retinol concentration is not a good indicator of vitamin A status. Serum acute-phase proteins     can indicate the severity and duration of an infection. Correcting vitamin A deficiency is     addressed in Ethiopia through vitamin A supplementation of children, dietary diversity and     using bio-fortified foods. However, assessing vitamin A status, and the effectiveness of     government interventions, is challenging in settings where infectious diseases are endemic,     as in most area of the country. Evaluation of vitamin A status is relatively insensitive when     based on changes in serum retinol concentrations, which are homeostatically controlled and     negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator     of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the     preferred method for determining vitamin A status and assessing the efficacy and     effectiveness of intervention programs aimed at improving vitamin A status. It is the only     indirect assessment method that provides a quantitative estimate of vitamin A status across     the continuum of deficient to excessive stores.   "
70428|NCT02363972|"     A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a     less invasive means of establishing vascular access to facilitate dialysis in patients with     end stage renal disease.   "
70429|NCT02363959|"     The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on     airway complications in post-lung transplant recipients with evidence of restricted levels of     blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in     the early post-transplant period will be randomized to HBOT or usual care and followed     clinically for 12 months following randomization. The investigators hypothesize that HBOT     will decrease the number of airway complications in the treated subjects.   "
70430|NCT02363946|"     The purpose of the study is to determine the safety and tolerability of escalating doses of     ARC-AAT and to evaluate the pharmacokinetics of ARC-AAT and the effect of ARC-AAT on     circulating levels of alpha-1 antitrypsin. The study will consist of two parts, Part A     (conducted in healthy volunteers) and Part B (conducted in AATD patients) at up to 9     escalating dose levels with 6 participants per dose level.   "
70458|NCT02363569|"     This is a prospective study, where the investigators will monitor pregnant women at 4-23     weeks of pregnancy coming to the Women- E.R. at Meir Hospital due to spontaneous -or     after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires     regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo     full examination including ultrasound. After discharge, the investigators will recommend to     all the women who came due to bleeding or bleeding secretions to avoid intercourse for two     weeks after the bleeding stops. Afterwards they will be monitored until their delivery date     (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy).     After they give birth the investigators will assess the rate of pregnancy, obstetric and     embryonic complications in each of the study groups.   "
70431|NCT02363933|"     This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive     anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory     partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this     study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime     for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments     per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of     perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a     maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose     can be modified by the physician based on patient reported tolerability. Titration and taper     periods will be determined by the physician in the case where patients do not reach the     planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center     Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24     weeks. Assessments will include history and physical examination (H&P) including Karnofsky     Performance Status (KPS), neurological examination, evaluation of seizure history,     patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of     16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking     6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel.     Patients will be considered off treatment at the end of week 20, once perampanel has cleared     their system. Patients will then be monitored through Week 24. Patients will continue to take     their original AED regimen after they stop perampanel. If seizure control is achieved during     the maintenance period or if seizures occur during the tapering period, patients can be     continued on perampanel per the discretion of the treating physician. In this instance,     perampanel will be prescribed by the treating physician and not provided within the confines     of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As     is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will     be given a log to record the number of seizures that occur. Research team members will     regularly contact patients for reminders and reports from the log. Safety will be assessed     with the following laboratory evaluations: complete blood count (CBC) with differential,     complete metabolic panel (CMP), and toxicity assessment.   "
70432|NCT02363920|"     Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in     hypoxic patients and ameliorate breathing pattern in hypercapnic patients.      The aim of this study is to better understand the physiological mechanism underlying these     results, assessing the respiratory mechanics in stable hypercapnic COPD patients.   "
70433|NCT02363907|"     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System     when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17     years-old with diabetes mellitus.   "
70434|NCT02363894|"     The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to     assess and estimate the long term effect of treating a vessel with plaque excision (PE) in     combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with     PTX PTA alone.   "
70435|NCT02363868|"     The purpose of this study is to examine the healthcare costs among patients with CML     receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured     population.   "
70436|NCT02363855|"     The primary objectives of this study are to investigate the safety and tolerability of BAY     1841788 in Japanese subjects with metastatic castration-resistant prostate cancer (mCRPC) and     the PK of BAY 1841788 and its major metabolite BAY 1896953.   "
70437|NCT02363842|"     The study is a multi-center, prospective, randomized, controlled, clinical study evaluating     the effects of microclimate management using Skin IQ™ MCM coverlet placed over commercially     available pressure redistribution surfaces compared to standard of care (SOC). The objective     of this study is to evaluate if a commercially available pressure redistribution surface when     combined with the Skin IQ™ MCM coverlet will significantly reduce pressure ulcer (PU)     incidence as compared to use of a commercially available pressure redistribution surface by     itself by decreasing the effects of excessive moisture and temperature at the skin and     surface interface.   "
70438|NCT02363829|"     Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical     carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV     cisplatin in combination as radiosensitizers with daily whole pelvic external beam and     intracavitary radiation brachytherapy.   "
70512|NCT02362815|"     We designed a two arms prospective, randomised, simple blinded trial to compare the impact of     clear liquid intake on gastric content before delivery. We hypothesize that there will be no     difference between the two groups, leading to safety of clear liquid intake during labour.   "
70439|NCT02363816|"     Weight gain, hypertension, high cholesterol and sugar abnormalities in childhood are strongly     linked and predict the risk of further complications and early death in adulthood. The newer     antipsychotics, called the second generation antipsychotics are commonly used to treat mood     disorders in adult and pediatric populations. Their use has substantially increased (up to     5-fold) in the past 15 years in children due to their approved use by the Food and Drug     Administration and higher acceptance in the general medical community. However, second     generation antipsychotics are known to have very damaging side effects that cause children to     gain substantial amounts of weight, have high cholesterol, high blood pressure and high sugar     levels. Despite the known risks their use is still needed and may be contributing to the high     rates of obesity-related diseases in childhood and ultimately shorter life-spans in     adulthood. How second generation antipsychotics cause these side effects is still not well     known. Preliminary evidence has identified a novel pathway that may be associated with second     generation antipsychotic side effects. This pathway has not been studied, is involved in     vitamin A metabolism and is called the beta-carotene pathway. Beta-carotene is an important     part of our diet because it acts as an anti-oxidant (fights harmful oxidative stress in the     body) and it produces the active form of vitamin A which is essential for several processes     in our body. The investigator's work has identified a backup in this pathway which the     investigators hypothesize is due to genetic variation of the enzymes found within this     pathway.      The investigators hypothesize that genetic variation in the beta-carotene pathway is     responsible for the side effects associated with second generation antipsychotics. The     investigators want to complete a cross-sectional, pilot study in the pediatric population     that will be used for future prospective, extramural applications.      The investigators propose two aims for this study:      Aim 1: Determine how second generation antipsychotics change beta-carotene metabolism. For     this aim, the investigators hypothesize that high beta-carotene:retinoic acid ratios will be     due to genetic varition in the beta-carotene pathway.      Aim 2: Define the relationship between beta-carotene metabolism, oxidative stress and second     generation antipsychotic induced insulin resistance. For this aim the investigators     hypothesize that low beta-carotene levels will be associated with high oxidative stress     levels and insulin resistance.   "
70440|NCT02363803|"     Diabetic nerve pain [painful diabetic peripheral neuropathy] is a common medical problem with     few reliably effective treatments. There is some evidence that sensory testing may help     determine how individuals will respond to analgesic therapy. In this study, the investigators     are evaluating the relationship between sensory testing and subject response to lidocaine     infusion therapy.   "
70441|NCT02363790|"     This study is comparing the outcomes patients undergoing LVHR, PFC as opposed to a bridged     repair with assessment of patient reported satisfaction and function at 6 months of     follow-up.   "
70443|NCT02363764|"     Accurate identification of lower respiratory tract pathogens is standard of care in the     management of CF patients and it is therefore recommended to perform regular bacterial     cultures, at least once a year, but some even recommend monthly cultures. This can be done     through different methods, of which sputum and bronchoalveolar lavage (BAL) are the gold     standard. However, BAL is an invasive method, not designated to repeat monthly. Therefore,     the diagnosis of lower respiratory tract infections can be challenging in the     non-expectorating CF patient. Other methods, such as induced sputum (IS), cough swabs and     nasal swabs, have been developed to obtain bacterial cultures in these patients. Studies have     investigated the reliability of these different sampling methods, however, with controversial     conclusions.   "
70445|NCT02363738|"     Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar     Disorders (BD). Increased levels of circulating proteins known as cytokines that promote     inflammation have been consistently reported in individuals with bipolar disorders. A     particular cytokine referred to as Tumor Necrosis Factor (TNF)-alpha is among those cytokines     that have been consistently identified across depressive, manic, and euthymic periods.     Disturbances in inflammation however, are not seen in all individual with bipolar disorder.     Those individuals with signs of inflammation also often present with higher prevalence of     medical disorders that are also associated with inflammation. Those individuals with     significant signs of inflammation may respond to anti-inflammatory treatments. In this study,     individuals with bipolar depression who exhibit signs of high inflammation will be enrolled     and treated with either an anti-inflammatory biologic known as infliximab or placebo     (saline).   "
70446|NCT02363725|"     Background:      Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.      More recnetly it is regularly use in the treatment of pericarditis. It couls exert     antiiflammatory effects targeting the adverse inflammation occuring incase of acute     myocardial infarction, which is involved in poor outcomes or longer stay at hospital.      Endpoints:        -  Main endpoint: AUC CRP during the initial hospital stay        -  Secondary endpoints:             -  Clinical: oucomes             -  Imaging: ETT, MRI             -  Biological: various biomarkers      Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal     optimal treatment versus conventionnal optimal treatment + colchicine   "
70447|NCT02363712|"     Painful knee osteoarthritis is common and treatments, short of knee replacement, are limited.     The investigators plan to test the efficacy of a novel promising device for treatment of knee     osteoarthritis affecting the inner part of the knee, the most common location. There are no     disease modifying treatments available and therefore there is an emphasis on conservative     management techniques to benefit individuals. Many of these treatments (insoles, braces,     physiotherapy etc) have been shown to have relative success in individuals but a new novel     device is demonstrating better effectiveness in this patient group. APOS (All Phases of Step)     therapy consists of a shoe oriented system of care that works by shifting the load across     parts of the knee and retraining the lower extremity muscles. Preliminary data suggest     impressive favourable reductions in knee pain and a commensurate decrease in knee loading     during walking. However, APOS treatment has never been evaluated in a randomised controlled     trial even though it is widely used among Bupa members and in other parts of the world. In     addition, no study has fully investigated the mechanism in which this treatment is aiding     knee pain, whether it is primarily a biomechanical (mechanics of movement) alteration, a     muscle strength and control change, or a combination of the two. The investigators propose to     conduct a randomised blinded controlled trial of APOS treatment among persons with painful     knee osteoarthritis affecting the inside (medial or lateral) of their knees. The     investigators will focus on pain outcomes and quality of life but to better understand how     and in whom APOS treatment is working, the investigators will also obtain data on loading     across the knee in the gait laboratory, along with measures of strength and function. In     addition to the standard pain scales, changes in knee structure on treatment using MRI     (Magnetic Resonance Imaging) will be analysed to determine whether bone marrow lesions (bone     bruises) are reduced as these are strongly linked with pain in individuals with medial or     lateral knee osteoarthritis, and are related to loading of the medial or lateral knee. APOS     has committed to provide the shoe system and a matched sham device, that they have developed,     and will also provide the technicians trained to calibrate the pertupods (balls under the     sole of the foot) on the shoe without charge. The research will be undertaken in a University     setting for the gait evaluations which has strong links with the Wellcome Trust Clinical     Research Facility in Manchester for the MRI imaging. Running a randomised controlled trial is     very labour and time intensive and therefore the team assembled has vast experience of     carrying out randomised controlled trials of other treatments in knee osteoarthritis, and is     experienced in both ethical requirements, recruitment and evaluation. The costs requested     reflect the nature of this research with a large proportion on staff costs and also non-staff     costs for the MRI imaging and other non-staff costs.   "
70450|NCT02363673|"     The aim of this study is to determine the effect of individualised homoeopathic treatment of     children with Autism Spectrum Disorder (ASD).This study is of descriptive case study design,     with a structured interview and quantitative measurement components taking place over 12     weeks, with a consultation every 4 weeks. Children aged 3-6 years of age with ASD are invited     to participate and their parent/guardian is required to be present during each consultation.     Each consultation will consist of a homoeopathic case taking, conduction of the Childhood     Autism Rating Scale (CARS) and Autism Treatment Evaluation Checklist (ATEC) measures and a     brief physical exam. After each consultation, the participant will receive an individualised     homoeopathic remedy, according to their individual symptoms and characteristics, to take for     the subsequent 4 weeks. This remedy will be determined using the Mercurius® repertory     software.   "
70451|NCT02363660|"     1. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine          in women given low doses of vaccine by the ID route with the NFI (Group III) to those          women given standard doses by the IM route with a needle and syringe (Group I) at 1          month, 6 months and 18 months following completion of the vaccination series.        2. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine          in women given standard doses of vaccine by the IM route with the NFI (Group II) to          those women given standard doses by the IM route with a needle and syringe (Group I) at          1 month, 6 months and 18 months following completion of the vaccination series.   "
70452|NCT02363647|"     The Personalized Discovery Process is the only program offering patients treatment     recommendations based on an empirically constructed Drosophila fly model of their disease.     Special committee selects one of the one of the few 2-3 FDA approved drug combinations or     single agents that improved survival in the fly cancer model.   "
70453|NCT02363634|"     A randomized double blind placebo controlled trial to evaluate the effects of a specialized     magnesium on mood states and sleep quality in older adults.   "
70454|NCT02363621|"     This study is designed to compare the post injection inflammation and pain seen after     intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.      The investigators will be evaluating patients (1-7 days) post injections for:      1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as     measured on a standardized pain scale).   "
70455|NCT02363608|"     The purpose of this study is to describe the effects of canine-assisted activity visits on     patients and staff in a hospital setting. The Caring Canines program uses dogs who have been     trained to be obedient, calm and comforting. It involves a visit by a volunteer (called the     dog's handler) and the volunteer's dog that has been trained and tested to have a good     personality and to follow commands. A visit typically lasts about 10-15 minutes with the     patient interacting with the dog while the dog is supervised by the handler. Memorial Sloan     Kettering currently has Caring Canine dogs visit patients but the investigators don't yet     know the impact of these visits on patients and staff. The investigators would like to see     how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense of     well-being. Two groups of patients will take part in this study - the first group will     receive standard post surgery care and will not receive a visit from the Caring Canines     program and the second group will receive daily visits (Tuesday -Friday) from the Caring     Canines program while they are on M15. The purpose of this study is to look at differences in     well-being between patients who have the visits with the dogs and patients who do not.   "
70456|NCT02363595|"     The purpose of this study is to identify specific clinical and molecular characteristics that     are predictive of tumor progression in small thyroid cancers.   "
70457|NCT02363582|"     Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of     beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that     both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated     colonic microflora.The purpose of this study is to investigate the stool     characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting     infant formula supplemented with prebiotics and lactoferrin.   "
70459|NCT02363556|"     This randomized controlled trial will use a 2 by 2 factorial design to assess methods of     cervical preparation prior to Dilation and Evacuations (D&Es) at 14 0/7 to 19 6/7 weeks     gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with     misoprostol and separately randomized to buccal or vaginal administration of 400-mcg     misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40     buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal and     40 buccal). Four to six hours later, the Dilation and Evacuation (D&E) procedure will be     performed.   "
70506|NCT02362893|"     The purpose of the study is to access the change in mean daytime systolic blood pressure in     participants with essential hypertension not adequately controlled (defined as mean systolic     daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an intervention     group with one-time only Direct Observed Therapy (DOT) immediately followed by ABPM or a     control group with standard ABPM.   "
70463|NCT02363504|"     The cause of Alzheimer's disease, the most common form of dementia, remains unknown.     Neuropathological studies suggest that a small area in the brainstem, the locus coeruleus,     might be the site of the onset of the disease. This area is the sole source of noradrenalin     to the brain, a neurotransmitter involved in arousal, but also cognitive functions. Animal     and pharmacological studies have hinted towards an important role of this area in memory     functioning. However, these studies were hampered by the limited spatial resolution, making     it hard to clearly localize the locus coeruleus in the brain. New developments in brain     imaging allow now to visualize the brain with stunning precision. Furthermore, a non-invasive     new stimulation method, transcutaneous vagus nerve stimulation, is believed to excite the     locus coeruleus and thereby influencing neuronal networks and memory functioning.      There are three aims in this project:        1. To investigate how the functional interaction between the locus coeruleus and other          brain areas, in particular the medial temporal lobe areas, during memory processes          (encoding, consolidation and retrieval) change with development of Alzheimer's disease.        2. To investigate associations between noradrenaline, memory performance and brain          functioning. The investigators aim to investigate how acute noradrenalin levels change          during the different memory processes and whether or not this is beneficial for          performance. Furthermore, the investigators will investigate whether this interaction          between noradrenalin, memory performance and brain functioning is different healthy          older individuals (n =35) or patients with prodromal Alzheimer's disease (n =35).        3. To investigate the underlying neural network changes during transcutaneous vagus nerve          stimulation. The investigators will focus on differences in functional connectivity          between the locus coeruleus and the medial temporal lobe areas in healthy older          individuals and prodromal Alzheimer's disease patients. An experimental condition will          be compared with a sham condition in a pseudo-randomized cross-over design.   "
70464|NCT02363491|"     The dose-confirming part of this study, comprising at least 10 patients is designed as a     single center, prospective, single arm, open label in patients who have failed or are     unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an     Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with an additional     30 patients; the objective of the whole study being to assess the safety, efficacy,     pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in     low and intermediate-1 risk myelodysplastic syndrome (Second line Lower risk MDS).   "
70465|NCT02363478|"     Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is     compromised in about 75% of patients. Previous studies have shown that buspirone, an orally     available 5-HT1A (serotonin 1a receptor agonist), enhances esophageal motility in healthy     volunteers. Recently, the investigators observed that a single dose of buspirone (10mg)     improves lower esophageal sphincter (LES) function in patients with SSc and esophageal     involvement .      Objectives: To evaluate the effect of continuous administration of buspirone on esophageal     dysfunction and related symptoms in SSc using high resolution manometry (HRM).   "
70466|NCT02363465|"     To optimize a medical device for intradermal injection, knowledge concerning the thickness of     epidermis and dermis at the proximal forearm is required. Since scientific knowledge is     lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults     using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they     are able to correlate the thickness of the (epi)dermis to a specific combination of     parameters age, gender, and BMI.      Based on these results, the investigators can define which needle type and length is needed     to correctly perform injections into the dermal layer.   "
70467|NCT02363452|"     The purpose of this study is to determine if treatment with reverse transcriptase inhibitors     returns the interferon signature observed in patients with AGS to normal levels.   "
70468|NCT02363439|"     An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.   "
70469|NCT02363426|"     The purpose of this study is to evaluate intravaginal culture using the medical device     INVOcell to generate day 5 blastocysts in comparison to traditional IVF.   "
70470|NCT02363413|"     The study is based on the assumption that in the Overlap Syndrome, the introduction at home     of the NIV is as effective in terms of compliance and clinical and gazometric improvement,     and life quality, that setting hospital start up. The investigators will study the initiation     of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main     objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at     home versus hospital in terms of compliance.   "
70471|NCT02363400|"     Nasopharyngeal carcinoma (NPC) is a geographically endemic, Epstein-Barr virus     (EBV)-associated carcinoma of epidermoid origin. It occurs most commonly in Southern China     and Southeast Asia. The NPC cells are poorly differentiated or undifferentiated with a high     incidence of lymphatic and hematological dissemination. Because of the inherent anatomic     constraints and a high degree of radiosensitivity, radiotherapy (RT) has been the primary     treatment for NPC patients.      NPC is also a chemosensitive tumor. Various modes of combined chemoradiotherapy have been     used to treat NPC patients with advanced-stage diseases during recent 20 years. However,     treatment outcome for locoregionally advanced NPC is still unsatisfactory.   "
70472|NCT02363387|"     The investigators propose to evaluate a novel incentive intervention to promote suppression     of viral load in people living with HIV that will employ empirically-based parameters that     have been proven critical to the effectiveness of incentive interventions. Participants (N =     200) from medical clinics that serve adults living with HIV in Baltimore will be randomly     assigned to an Incentive or a Usual Care Control group. Incentive group participants will     receive incentives for maintaining suppressed and undetectable viral loads. The incentive     program will employ high magnitude incentives, provide incentives for decreases in viral load     early in treatment before a patient's viral load has reached undetectable levels, arrange     frequent incentives early in treatment and reduce the frequency of incentives as participants     achieve progressively longer periods of viral load suppression, arrange a schedule of     escalating incentives for sustained suppression of viral load, and the intervention will be     maintained for two years. Usual Care Control participants will only receive the standard HIV     medical care offered in their clinic. Assessments will be conducted every 3 months throughout     the two years of treatment and every 6 months throughout the year following treatment. The     primary outcome measure will be the percentage of participants that have undetectable viral     loads at the 3-month assessments conducted throughout the 2-year intervention period.     Secondary measures will include adherence to HIV care and post-treatment outcomes. The     investigators will also assess moderators and mediators of the effects of the incentives on     the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If     the incentive intervention maintains suppressed viral load and is economically sound, it     could be used to improve the health of adults living with HIV, reduce health care costs, and     reduce HIV transmission in the community.   "
70507|NCT02362880|"     The main purpose of the study is to assess safety of a single dose of FBB followed by PET     scan in individuals at risk of genetic Alzheimer's disease.   "
70508|NCT02362867|"     The protocol will define the clinical study for Ortho Development's Balanced Knee® System     (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical     study will compare the clinical outcomes of BKS to currently marketed devices.   "
70509|NCT02362854|"     The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to     conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective     clinical, radiographic and microbiologic split-mouth study was conducted to test the     following null hypothesis; adjunct application of a diode laser, in the conventional     treatment of peri-implantitis, are not associated with a statistically significant difference     regarding the microbial counts, marginal bone loss and peri-implant parameters.   "
70473|NCT02363374|"     Preoperative 5-FU-based (5-fluorouracil) chemoradiotherapy (CRT), total mesorectal excision     surgery, and 4 cycles of adjuvant 5-FU - as established by CAO/ARO/AIO-94 - is at present a     standard of care for patients with locally advanced rectal cancer (UICC stage II and III).     The phase III German CAO/ARO/AIO-04 trial showed, that the addition of oxaliplatin increased     treatment efficacy in terms of early secondary efficacy endpoints (e.g. the pCR-rate). With a     median follow-up of 50 months, the primary endpoint of this trial - disease free survival -     was significantly improved in the oxaliplatin-containing treatment arm (3-year disease-free     survival (DFS) 71.2% versus 75.9%, hazard ratio (HR) 0.79, 95% confidence interval (CI)     0.64-0.98, p=0.03). The hereby proposed randomized phase II trial CAO/ARO/AIO-12 aims at     finding novel and innovative aspects of rectal cancer treatment, and will thus provide     important information for defining the experimental arm in the upcoming large scale trial of     the group. Compared to the current standard, in both study arms, the sequence of the three     treatment modalities is modified, placing the chemotherapy block before surgery. The     pre-operative sequence of chemotherapy -> chemoradiotherapy (arm A) has been shown to be     feasible with no early tumor progression prior to definitive surgical resection in a small     randomized phase II study from Spain. The sequence chemoradiotherapy -> chemotherapy (arm B)     may be beneficial according to response kinetics considerations, and by maintaining a highly     effective local treatment in the first place. Both approaches could avoid the problem of     major compliance problems with post-operative adjuvant chemotherapy. CAO/ARO/AIO: German     Rectal Cancer Study Group   "
70474|NCT02363361|"     This is a phase II, single center, open-label, non randomized clinical study to assess the     uptake, safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients.     The aim is to determine if Imatinib reaches sufficient blood levels when given to patients     with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety     and tolerability of this drug treatment.   "
70475|NCT02363348|"     Randomized double-blind controled clinical trial to assess the efficacy and safety of     L-arginine to prevent preeclampsia.      applied to pregnant women with risk factors for preeclampsia. the main result was the     development of preeclampsia as well as side effects to taking l arginine besides perinatal     outcomes   "
70476|NCT02363335|"     Background:      The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease     (COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that     this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is     a medication presently used to treat diabetes. Researchers think that both of these drugs may     decrease blood sugar by causing an increase in the hormone GLP-1.This hormone is secreted in     the small intestines and stomach and is also known as an incretin. Researchers want to study     how these drugs affect blood sugar, insulin, and other hormones in the blood.      Objectives:        -  To study the effects of Roflumilast (Daliresp) and Sitagliptin (Januvia) on blood sugar          and insulin.        -  To better understand GLP-1 and other gut hormones. This may lead to new treatments for          type 2 diabetes.      Eligibility:        -  Healthy volunteers age 21 55.        -  Body Mass Index (BMI) less than 30      Design:      -This study will require one screening visit and four study visits, scheduled about 3-weeks     apart.      Screening visit requires participants to arrive after fasting for 10 hours and have the     following:        -  Medical history, physical exam, height, weight, blood pressure measurements and blood          and urine tests.        -  A 2-hour oral glucose tolerance test (OGTT). Participants will drink an orange-flavored          drink containing 75 grams of sugar (300 calories). A blood sample will be taken prior to          drinking the beverage and 2-hours later.        -  An electrocardiogram (EKG) to measure the electrical activity of the heart.        -  Questionnaires about risk for depression or suicide.      Study visits 1to 4:        -  Participants will arrive the evening prior and blood work will be done to confirm          eligibility. They will not eat or drink anything except water starting at 8:00 p.m.        -  About 6:30 a.m. the following day, an I.V. (small plastic tube) will be placed in an arm          vein and used to take 20 blood samples over a period of about 11 hours.        -  Participants will receive one of the following study medication/placebo groupings in          random order:             1. Roflumilast (Daliresp) 500 mcg pill; and 1 placebo pill             2. Sitaglipitin (Januvia) 100 mg pill; and 1 placebo pill             3. Roflumilast (Daliresp) 500 mcg pill; and Sitagliptin (Januvia) 100 mg pill             4. 2 placebo pills        -  One hour later, they will have a 10-hour mixed meal test (MMT). They will be asked to          drink a nutritional shake (Ensure Plus). Blood samples will be taken over the next 10          hours to measure blood sugar, insulin and other hormones. At the end of the test, they          will be given a meal.        -  Participants will answer questions about side effects and symptoms. They will receive a          follow-up phone call within 10 days.   "
70477|NCT02363270|"     Our recent research comparing the efficacy of intravenous ketamine to morphine has shown     ketamine to provide equivalent relief of moderate to severe acute pain in emergency medicine     patients. Secondary analysis of the research has also revealed ketamine to have statistically     more side effects. The investigators believe that increasing the time of administration of     the ketamine, from a push injection to a drip infusion, will minimize the side effects     experienced by recipients of ketamine.      During our Ketamorph trial the investigators saw that 70% of patients receiving ketamine     experienced a known side effect of the medication, compared to 51% of the morphine group. The     most common side effect was dizziness (22 of 45 pts), Feeling of Unreality (12 of 45), Mood     Changes (6 of 45). During this trial there we NO adverse effects that we beyond the expected     side effects profile of either medication and none of the participants required intervention     as a result of the study medication.   "
70478|NCT02363257|"     Three years since the Smoke Free Mumbai campaign and six years since the ban on smoking in     public places was implemented. It is necessary to review the situation at this point in time     so that corrective actions if necessary can be taken. Hence, this study is planned to     understand the perceptions and attitudes of commuters and bus employees (drivers, conductors     and ticket checkers) regarding the law, its implementation, reactions from the commuters,     violations observed, violations reported.      This study will help evaluate the implementation of provision of prohibiting smoking in     public places and help understand how to increase the compliance. The results will inform     enforcement and public health agencies about where to target enforcement and public education     resources.   "
70479|NCT02363244|"     This is a pilot study to assess the cell adequacy and quality of Pap smears and adequacy of     samples for HPV DNA virus test done after application of 5%acetic acid in a VIA test.Normally     a Pap test and HPV DNA test is performed before application of acetic acid. It is assumed     that application of acetic acid may alter the cell adequacy of Pap test and HPV DNA test, if     any of the above tests is done immediately after VIA test.The present study aims to see the     effect of 4-5% acetic acid [vinegar] on the cell adequacy and quality of Pap smear and sample     adequacy for HPV DNA test.   "
70480|NCT02363231|"     The process of weaning from mechanical ventilation was decided after clinical judgment and     weaning predictive index. Nevertheless, indexes predicting weaning outcome like Maximal     Inspiratory Pressure (MIP) are frequently inaccurate. However the long-term involvement of     respiratory muscles in critically ill patients has not been established. The objective of     this study was to assess the relationship on MIP at extubation on one-year mortality in     critically ill patients.   "
70481|NCT02363218|"     Study Phase: multi-institutional Phase II study Primary Objective(s): To determine overall     survival for HCC patients treated with CyberKnife SBRT at 2 years.      Secondary Objective(s): 1) To determine overall survival for HCC patients treated with     CyberKnife SBRT at 1 year 2) To determine local control using RECIST and EASL criteria at 1     and 2 years 3) To assess progression-free survival at 1 and 2 years 4) To assess acute and     late toxicities following CyberKnife SBRT.      Hypothesis: Overall survival rate of HCC patients at one year after SBRT treatment is not     less than 65%.      Study Design: Single arm study. Patients will undergo a CT scan with and without contrast and     MRI scan for radiation treatment planning and target delineation.SBRT will be delivered on     the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be tracked     with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3 fractions     within a 7 day window at the discretion of the investigator.      Sample size: The sample size required is 93 with a power of 90%, p=0.05, 50% response rate is     considered not effective (p0) and 65% overall survival rate at 1 year (p1) is considered     effectiveness of the treatment. The estimated drop-out rate is 20%, so the total sample size     would be 117.      Statistical Considerations: The set of Intention-To-Treat (ITT) will be analyzed. All     patients will be censored at their last visit, including the patients lost to follow-up. All     patients will be followed and counted in the therapy to which they were assigned, even if     they decline that therapy. Only those patients who refuse (in writing) to have their outcomes     count in the study's conclusions will not be included in the analyses from that time forward;     however, the follow-up data for such patients will be included up until the time they     withdraw consent. Such patients will be replaced.      Baseline characteristics of patients will be presented with summary statistics. Time-to-event     survival rates for OS and DFS will be estimated using the Kaplan-Meier method and presented     at one and/or two years. The incidence of acute and late toxicities will be presented in     tabular form on both a per-patient and per-event basis.   "
70482|NCT02363205|"     The purpose of this study is to determine whether tailored internet-administrated cognitive     behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and     comorbid anxiety symptoms.   "
70483|NCT02363192|"     Of the 5.2 million people with asthma in the UK, approximately one in every 40 have severe     asthma that needs the maximum available treatments advised in national asthma guidelines     (known as the 'British Thoracic Society / Scottish Intercollegiate Guidelines Network British     Guideline on the Management of Asthma'). Despite this, asthma is still inadequately     controlled in about half of these patients and they are classed as having 'difficult asthma'.     There maybe potential for improvement of the care and health of these patients through better     use of medicines and greater input from pharmacists, but more research is needed.      The aim of the study is to measure the effects over six months of coordinated information and     advice about medicines from hospital and community pharmacists on asthma control in patients     with difficult asthma. The patients in the study (52 in total) will be recruited from adult     patients attending a specialist difficult asthma clinic in a hospital.      Patients will be randomly chosen to have either an appointment with the specialist pharmacist     (intervention group), or usual medical care (control group). Usual care will involve seeing     the Consultant or Specialist Registrar (doctor) in the clinic. Patients in the intervention     group will receive i) assessment and education on asthma, and review of their inhaler     technique, from a hospital Advanced Clinical Pharmacist and ii) will also be referred for a     medicines use review from their usual community pharmacist (chemist), to take place 1-2     months after their hospital clinic appointment. The Advanced Clinical Pharmacist will be     working closely with the Consultant.      Results will be measured using methods that have been developed by experts in asthma and     tested in previous research. Asthma control will be measured using Juniper's Asthma Control     Questionnaire. Other measurements will cover quality of life, use of medication, use of     healthcare resources, and inhaler technique.   "
70484|NCT02363179|"     The investigators will conduct a prospective quasi-experimental design study of patients in     the University of Florida Health Emergency Department. Live preferential music will be     performed for patients in the emergency department on alternating days over 20 weeks, and     subjects exposed to the music intervention will be matched to a cohort that present to the     emergency department on days with no music to assess impact on patient and healthcare     provider satisfaction, pain medication utilization, length of stay, and cost of care.   "
70485|NCT02363166|"     Given that the Emergency Department (ED) has become the entry way for large populations of     patients into the health care system, a strategy of sampling MRSA isolates in ED populations     and merging this information with patient-level data may present a window to hypothesize and     investigate CA-MRSA transmission within the community and its impact on hospital-acquired     infections.   "
70486|NCT02363153|"     This study examines the effects of individualized diet and exercise plans on muscle strength,     quality of life and respiratory function in Pompe disease. Subjects will be given a diet and     exercise plan based on their individual needs, which will be followed for 16 weeks.     Participants will also be provided with an activity tracker in order to track their exercise     activities, access to an app that will allow them to input their daily food intake, and they     will also come to the University of Florida for exercise tests, respiratory tests and     questionnaires.   "
70487|NCT02363140|"     The menisci in the knee joint are important for normal functioning of the knee. Meniscus     tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the     meniscus tears determines the treatment plan and outcome. The surgeon identifies the blood     supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the     treatment option ie repair versus partial meniscectomy.      This study aims to identify any changes that occur in the meniscus blood supply. The     following are the main aims of the 'MOVE'study-        1. Use of non-invasive methods ie MRImaging to assess meniscus vascularity to          preoperatively plan treatment and advice patient on recovery.        2. The study would assess changes in meniscus blood supply depending on age of the patient.        3. The study aims to assess the alteration in meniscus blood supply following an          arthroscopic(key hole) meniscal repair operation.   "
70488|NCT02363127|"     Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the     impact on the ongoing pregnancy rate with the use of two progesterones with different     administration routes, in recipients of fresh embryos from donor oocytes, undergoing     endometrial preparation for fresh embryo transfer.   "
70489|NCT02363114|"     The primary objective of this study is to determine whether baseline DOC screening can add to     clinical and demographic data to predict the occurrence of a composite negative outcome (any     of: recurrent stroke, myocardial infarction, death, or admission to a long-term care (LTC) /     complex continuing care (CCC) facility) within one year of screening, in stroke prevention     clinic patients.   "
70490|NCT02363101|"     The purpose of this study is to evaluate the costs, health-related quality of life and     preference values from lung cancer patients assisted in a Brazilian public health care unit.   "
70529|NCT02362581|"     Comparison of prophylaxis and on-demand treatment in children with moderate to severe     hemophilia A.      This study determines to compare the efficacy of prophylaxis and on-demand treatment in     moderate to severe hemophilia A children in King Chulalongkorn Memorial Hospital, Bangkok,     Thailand   "
70510|NCT02362841|"     There are no available criteria for determining the optimal flow rate and mean arterial     pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide     tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for     guiding hemodynamic optimization under CPB. The goal of this exploratory study was to     determine the factors that influence PtCO2 variations during CPB.      DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every     10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital     PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively     included.   "
70491|NCT02363088|"     Cervical cancer is the most common cancer in women under 35 years and is a major public     health concern. Fortunately, the natural history of this malignancy can be beneficially     improved through cytological screening. However, the success of screening programmes depends     on their ability to attract the at risk population, as well as the analytical sensitivity     and specificity of the screening test. In the UK, screening consistently falls short of the     80% national target and recent evidence shows uptake is decreasing, in part due to the     introduction of HPV vaccination programmes. In the under 30s London population, average     coverage only reached 50% in 2013. Given this information, the cervical screening programme     is under increasing pressure to improve uptake, and need an evidence based intervention.      We aim to improve the uptake of cervical screening using SMS messaging through a randomised     controlled trial. The trail will evaluate both the prevalent and incident rounds of screening     and within the intervention group, analyse how the content of text reminders influences their     effectiveness. Specifically we will evaluate a) neutral b) messenger c) social norms d)     framed gain/loss reminders. Unlike our previous trial, this SMS reminder will encourage the     booking of an appointment which has never been tested, rather than simply reminding women to     attend. All women being invited for cervical screening, registered at participating GPs     within Hillingdon will be eligible to participate. Women will also be provided with a 2 week     window during which they can opt out of the research. Given the sample sizes we predict the     trial will take 9 months.   "
70492|NCT02363075|"     The main purpose of this study is to estimate the efficiency at 3 months of dexamfetamine     sulphate on the MFI 20 scale in severe fatigue of patients with stabilized gliomas.   "
70493|NCT02363062|"     The major objective of the project is to map/identify new loci/genes, by a combination of     whole exome sequencing and genome-wide linkage in autosomal dominant FTLD families excluded     for known mutations.      Several secondary goals will be attained in the course of during the project:      For each novel gene identified in this project, we will determine the spectrum of mutations,     evaluate their frequency and characterize the associated phenotypes. This will allow us to     establish genotype-phenotype correlations in a large number of families, which will improve     the nosology of these disorders and the diagnostic procedures;   "
70494|NCT02363049|"     The present study is a multicentric randomized phase III trial designed to assess whether     overall survival and quality of life are improved in patients with asymptomatic colon cancer     and unresectable SLM treated with resection of the PT followed by chemotherapy versus     chemotherapy alone.   "
70495|NCT02363036|"     Accumulating evidence suggest that the proliferative, invasive, and immune tolerance     mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the     host immune response are similar to those used by the developing placenta during normal     pregnancy. In addition to the shared capacity for invading through normal tissues, both     cancer cells and cells of the developing placenta create a microenvironment supportive of     both immunologic privilege and angiogenesis.      CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that     consist of immature myeloid cells (IMCs), and were first described as myeloid-derived     suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow     differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells     have been shown to play an essential role in mediating immune suppression in animal models of     human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been found     in peripheral blood, lymphoid organs and the tumor tissue itself. An increased population of     IMCs was identified in patients with several tumor types. Accordingly, IMCs detected in the     peripheral blood of such patients bearing express the common myeloid marker CD33 but lack     markers of mature myeloid cells such as the MHC class II molecule HLADR.      IMCs have been shown to actively promote tumor growth and metastasis by modulating the     cytokine environment, and through vascular remodeling by promoting angiogenesis.      It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice     and actively promote angiogenesis. These cells show striking similarity to IMCs that populate     malignant tumors. Accordingly, human placentas are also infiltrated by a significant     population of IMCs. Immunostaining of human placentas showed that IMCs comprise around 25% (     range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells and that this     population is located close to blood capillaries. We also demonstrated that immature DCs,     cells originally described to regulate the adaptive immune response, also promote     angiogenesis in models of choroidal neovascularization, endometriosis and tumors.      This is a retrospective study on patient's blood samples of pregnant women who came to     delivery in our department during 1.1.2014-31.12.2014, to compare the abundance of monocytes     and neutrophils in: 1. Term active labor. 2. Elective cesarean section.      According to our previous findings, we hypothesize that monocytes in active delivery will be     lower than in women without signs for labor. We also hypothesize that neutrophils will be     more abundant in active delivery than in women without signs for labor.      We plan to screen anonymous electronic data of women who delivered in our departement during     2014 according to the following eligible criteria, stratified into 2 categories: 1. Women who     were admitted in active labor. 2. Women who were admitted for elective Cesarean Section     without signs of labor.      We will compare the abundance of monocytes and neutrophils in blood counts that were taken on     admission day between the two populations.   "
70496|NCT02363023|"     The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic     bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic     bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator     associated pneumonia and their impact in morbimortality.   "
70497|NCT02363010|"     The major goal of this project is to evaluate an innovative approach to obesity. This study     will determine if behavioral treatment can be improved by 1) implementing a primary focus on     PA following initial weight loss treatment, and 2) using a novel, acceptance-based approach     to the promotion of PA.   "
70498|NCT02362997|"     This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using     the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation     therapy after autologous stem cell transplant (ASCT), in patients with relapsed or refractory     (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or peripheral     T-cell lymphoma (PTCL) in 1st remission.   "
70499|NCT02362984|"     This is a prospective, randomized, double-blind, and controlled clinical study to investigate     the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy     alone in acute ischemic stroke patients.   "
70500|NCT02362971|"     The aim of this study is to evaluate the external validity of a randomized controlled trial     comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced     femoral neck fracture.      The hypotheses are that patient reported hip function, quality of life are better and     healthier in those included in the randomized controlled trial than those excluded. The     external validity of the randomized controlled trial is acceptable.      A prospective randomized controlled trial is planned and patients with a displaced femoral     neck fracture will be included and randomized between either a hemiarthroplasty or total hip     arthroplasty. All patients screened will be included in a prospective cohort study for     evaluation of the external validity of the randomized controlled trial. The prospective     cohort study will consist of 3 different groups.      Patients included in the randomized controlled trial will form group 1. Patients eligible for     the randomized controlled trial but did not give their informed consent and therefore     excluded, form group 2.      Patients with a femoral neck fracture which by any reason were excluded form group 3.      Primary endpoint is patient-reported hip function (Harris hip score) and pain on the operated     extremity evaluated with VAS (Visual Analogue Scale) and patient reported quality of life     evaluated with EuroQol (EQ-5D). Secondary outcome measurement are the frequency of the     complications, periprosthetic fracture, dislocation, revision surgery due to wound infection     (deep and superficial) and loosening of the components. Baseline data, age, sex, comorbidity,     cognitive status, weight, height, motor function, complications and reoperations. Follow up     is performed 1-2 years after surgery.      Group 1 is followed up in the ongoing randomized controlled trial by visits to the orthopedic     department at Danderyd Hospital. Group 2 and 3 are followed up by telephone interview 1-2     year after surgery.   "
70501|NCT02362958|"     Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With     Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.   "
70530|NCT02362568|"     The purpose of this study is to determine if cervical ultrasound exploration can predict     difficult intubation better than main validated clinical criteria.   "
70531|NCT02362555|"     Ossification of nuchal ligament often observed in patient with chronic neck pain, previous     study showed ossification of nuchal ligament was associated with cervical spondylosis and     radiculopathy. Patient with chronic neck pain was divided into two groups according to the     presence of ossification of nuchal ligament on cervical radiographic images.      This study is to evaluate and compare the neck function including range of motion, neck     strength and pressure pain threshold, radiography characteristics and functional disability     between two groups.   "
70502|NCT02362945|"     Post-Partum Hemorrhage (PPH) is a common obstetrical complication. It may occur after both     vaginal and cesarean delivery with a reported prevalence of 4-6% of deliveries [1].     Prophylactic treatment with oxytocin after fetus extraction is a common practice.     [1,2]Transexamic acid - Hexakapron is a potent antifibrinolytic, it prevents lysine adhesion     to plasminogen molecules by blocking its binding site. It can lower fibrinolysis rate and by     that reduce bleeding [9]. Systematic treatment of anti-fibrinolytic drugs is in surgical     practice after procedures such as coronary artery bypass graft, orthopedic surgeries and     liver transplantation [10-13]. Hexakapron is an FDA approved drug, it is defined as a class B     drug for pregnancy and lactation [12], it is already being used in a non-routine fashion in     the delivery room during PPH.In obstetrics Hexakapron given before vaginal or cesarean     delivery has been presumed to decrease blood loss and PPH. 2 studies that included 453 woman     reported decrease in PPH (RR 0.51, 95% CI 0.36 to 0.72) [13-15]. However specific protocols     for prophylactic treatment with Hexakapron as available with oxytocin are lacking, and     further research is necessary to determine such guidelines [16].   "
70503|NCT02362932|"     The purpose of this study is to determine the health impact of a basic sanitation     intervention in Maputo, Mozambique.   "
70504|NCT02362919|"     The aims of the study are to a) identify individuals with a poor response to influenza     vaccination and b) identify factors associated with a poor response to influenza vaccination.   "
70514|NCT02362789|"     The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and     lesional biomarkers during 16 weeks of treatment with 300 mg secukinumab in patients with     moderate to severe psoriasis and a high pruritus involvement at baseline. For patients who     achieve extensive remission defined as a PASI response of 98-100%, the kinetics of psoriasis     and pruritus symptoms will be further explored during a randomized withdrawal phase of 16     weeks. Biopsies will be taken to investigate lesional biomarkers related to the pathogenesis     of pruritus in psoriasis patients.   "
70515|NCT02362776|"     This study aims to determine whether metabolic changes occur in blood plasma of cancer     patients, and whether these changes can be used as a biomarker to detect cancer. These     analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.   "
70516|NCT02362763|"     Randomized controlled trial designed to determine whether acupuncture is an effective     treatment for vestibulitis.   "
70517|NCT02362750|"     The Evaluating Cancer Survivorship Care Models project is an innovative 3-year study that is     collecting data to help understand how to best deliver follow-up care to cancer survivors.     Cancer is a complex disease requiring complex treatments that can cause lasting impacts after     treatment ends. Some patients face physical, psychosocial, spiritual and/or practical     challenges as they adjust to life after cancer. Fortunately, health care providers have begun     to focus on the consequences of cancer and its treatment and are more actively working with     cancer survivors to manage post-treatment needs and care.      Led by the George Washington University and funded by the Patient-Centered Outcomes Research     Institute, this project brings together representatives from the Commission on Cancer, the     Cancer Support Community, LIVESTRONG and the American Cancer Society as well as cancer     survivors and healthcare professionals to better understand how different strategies or     models of care impact outcomes that are most important to cancer survivors. The project will     focus on survivors of breast, prostate and colorectal cancers and will be relevant for     understanding the needs and preferences of survivors of other cancers as well. The emphasis     is on patient-centered outcomes, which are outcomes that are most significant to patients,     such as patient satisfaction and quality of life.   "
70518|NCT02362737|"     This study will test ways to improve health behaviors using an intervention that has been     specially designed for African-American men. The program, called Active & Healthy Brotherhood     (AHB), will provide information on basic health, and healthy eating, physical activity,     stress management, and how to get medical care when needed.The AHB intervention will be     compared to a control group that will receive basic health information in videos and     brochures.   "
70519|NCT02362711|"     The purpose of this long-term study is to determine whether NPC-16 is effective in the     treatment of dysmenorrhea.   "
70520|NCT02362698|"     this research adopted multicentered, randomly and parallel control methods to observe the     clinical effects of electro-acupuncture combined psychological intervention on internet     addiction disorder, aim to provide a convenient, affordable and effective clinical protocol.   "
70521|NCT02362685|"     Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of     using functional tests when this diagnosis is suspected. Exercise increases the concentration     of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia)     especially during recovery. The purpose of this study is to compare the results of exercise     testing with to the data from muscle biopsy or genetic analysis.   "
70522|NCT02362672|"     The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is     effective for the relief of moderate to severe chronic low back pain as compared to a     placebo.   "
70523|NCT02362659|"     The purpose of this observational registry is to compare the safety and efficacy of an     antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic     versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry     will assess whether the antithrombotic therapy intensity will vary positively with physician     perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether     an inverse association will be observed with perceived bleeding risk.      This study will also evaluate the physician use of objective benefit-risk assessment scores     and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF)     patients undergoing PCI. Additionally the study will investigate whether patient perceived     relevance and accessibility of anti-platelet and anticoagulant treatment regiments will     predict treatment adherence and whether non-adherence will independently influence outcome.      Approximately 2500 subjects with non-valvular AF undergoing all-comer PCI with stenting will     be enrolled in North America and Europe, sites to be determined. Follow-up will be done via     telephone by trained research coordinators at each participating site at 30 days, 6 months     and 12 months.   "
70525|NCT02362633|"     The purpose of this study is to investigate the long-term effect of Transcranial Direct     Current Stimulation (tDCS) on appetite control related brain regions.   "
70536|NCT02362490|"     Antiviral therapy is the most important method to slow and stop the progress of the disease     in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively     suppress HBV replication, but it should be continue used and relapse would happen in most     patients after withdrawal of therapy. However, long-term use of NA could induce viral     resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and     non-specific immune function in chronic hepatitis B patients, make patients get immune     control to HBV infection and obtain sustained response after treatment. Thus the CHB patients     on the treatment of NA should be stop NA treatment after interferon treatment. In this study,     the effects of interferon treatment in CHB patients who were on the NA treatment and obtained     HBsAg level≤250 IU/ml.   "
70537|NCT02362477|"     The immediate objective of this project is to evaluate the clinical effectiveness of a     telemental health modality (video-teleconferencing) for providing an evidence-based group     intervention to female rural veterans, Reservists, National Guardsmen, and civilians     suffering with PTSD. This study is an expansion, seeking to add a treatment arm of women, to     an already CDMRP-funded study that completed in July 2014 treating male combat veterans with     military-related PTSD. The long-term objective of this project is to disseminate an     empirically sound TMH PTSD protocol for male and female veterans, Reserve and Guard that will     extend the use of CPT to remote rural sites. It is hypothesized that using VTC, will be as     effective as the in-person mode of service delivery for providing CPT.   "
70538|NCT02362464|"     Background:      - Few studies or literature are available about the long-term safety of repeated peptide     vaccinations in people over a period of time. Long-term vaccination may be needed to control     tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they     want to give those same men the new version of the vaccine. They want to see if it produces     different types of immune responses and also ensure that repeated vaccinations are safe.      <TAB>      Objectives:      - To find out the long-term safety of repeated TARP peptide vaccinations.      Eligibility:      - Men who took part in NCI protocol 09-C-0139.      Design:        -  Participants will be screened with blood tests, scans, physical exam, medical history,          and an evaluation of how well they perform everyday activities.        -  Participants will have apheresis. Blood will be removed with a needle from one arm. A          machine will separate the white blood cells. The blood, minus the white cells, will be          returned through a needle in the other arm.        -  Participants will have 14 visits. At each visit, they will have a physical exam and          blood tests. They will discuss any side effects.        -  Participants will get vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine          will be made from the participants own cells.        -  Participants will get a Vaccine Report Card to complete after receiving vaccine.        -  The study lasts 96 weeks.   "
70539|NCT02362451|"     Background:      - Men who continue to have an elevated or rising prostate specific antigen (PSA) level after     their primary prostate cancer treatment are at increased risk for their cancer to progress.     The time it takes to progress is highly variable. One way to predict this progression is     based on the change in PSA levels over time. This is called the PSA doubling time (PSADT).     Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the     PSA has become detectable again or has started to rise after primary treatment, but has not     spread to other organs.      Objectives:      - To test a vaccine s effectiveness on the rate of PSA increase using PSADT and tumor growth     rates.      Eligibility:      - Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months.      Design:        -  Participants will be screened with blood tests, scans, physical exam, and medical          history. Their prostate cancer will be confirmed.        -  Participants will undergo apheresis. Blood will be removed with a needle from one arm. A          machine will separate the white blood cells. The blood, minus the white cells, will be          returned through a needle in the other arm.        -  Participants will have 14 visits. At each visit, they will have a physical exam and          blood tests. They will discuss any side effects.        -  Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12,          15, and 24. Both will be made from the participants own cells.        -  Participants will be selected randomly to receive either active vaccine or placebo. For          every two participants assigned to active vaccine, one participant will be assigned to          placebo vaccine.        -  Participants will get a Vaccine Report Card to to complete after receiving vaccine.        -  The study lasts 96 weeks.   "
70540|NCT02362438|"     Background:      - The Gigaxonin gene lets the body make a protein chemical called Gigaxonin. Nerves need     Gigaxonin to work properly. Giant Axonal Neuropathy (GAN) causes a shortage of functional     Gigaxonin. Nerves stop working normally in people with GAN. This causes problems with walking     and sometimes with eating, breathing, and many other activities. GAN has no cure. Over time,     GAN can shorten a person s life. Researchers want to see if a gene transfer treatment may     help people with GAN.      Objectives:      - To see if a gene transfer is safe and shows potential to help people with GAN.      Eligibility:      - People age 5 and older with GAN.      Design:        -  For 2 months participants must live full-time within 100 miles of the NIH.        -  Participants will be screened by phone and in person. They will take many tests. Some          are listed below. Their medical records will be reviewed. Their caregivers may be          contacted.        -  Participants will have a total of about 30 visits, weekly, monthly, and then yearly over          15 years. They will include many of the tests below.        -  Physical and nervous system exams.        -  Blood, urine, and stool samples.        -  Nerve, lung, heart, and eye tests.        -  Questionnaires.        -  MRI scans, nerve biopsies, and spinal taps. Participants will be sedated for some tests.        -  Speech, memory, muscle, and mobility tests.        -  Skin biopsy (small sample removed).        -  Participants will take many medicines. Some require intravenous lines.        -  Participants will get the gene transfer through an injection by spinal tap into their          cerebrospinal fluid, which flows around the brain and spinal cord. The genes are packed          in a modified virus that carries the genes to cells in their body. Participants safety          is not guaranteed.   "
70587|NCT02361827|"     To date, several studies have been done to explore the relationship between Vitamin D level     and IVF outcome; however, the results are controversial. Sample sizes in these studies     mentioned above were relatively small. In addition, there are no prospective cohort studies     in this field. Thus, here the investigators carry this prospective observational cohort study     to demonstrate the relationship between vitamin D level and IVF outcome.   "
70541|NCT02362425|"     Background:      - Ryanodine receptor type 1-related myopathies (RYR1-RM) are the most common muscle diseases     that people are born with in the U.S. They affect development, muscles, and walking.     Researchers want to test a new drug to help people with these diseases.      Objectives:      - To see if the drug N-acetylcysteine decreases muscle damage in people with RYR1-RM. To see     if it improves their exercise tolerance.      Eligibility:      - People age 7 and older with a confirmed genetic diagnosis of RYR1 or a clinical diagnosis     of RYR1 and a family member with a confirmed genetic diagnosis.      Design:        -  Participants will be screened with a checklist of criteria. They will have a muscle          biopsy. A needle will remove a tiny piece of muscle in the lower leg.        -  Study visits will take several days.        -  Visit 1:        -  Medical history        -  Physical exam        -  Blood, urine, and saliva tests        -  Questions about symptoms and quality of life        -  Heart, lung, and walking tests        -  Muscle Oxygenation Capacity Test. A blood pressure cuff around the thigh will be          tightened for up to 10 minutes.        -  Biodex testing, stretching the leg against resistance        -  Muscle ultrasounds. A probe will be moved over the skin.        -  Participants may be photographed or videotaped during procedures.        -  They may have a muscle biopsy.        -  Six months later, visit 2 will repeat visit 1. Participants will start taking the study          drug dissolved in water or placebo three times a day for 6 months.        -  Participants will stay at NIH for 2 days after starting the study drug.        -  Participants will keep an online pill diary daily and be contacted by phone during the          study.        -  Six months after starting the study drug, study visit 3 will repeat some or all of visit          1.   "
70542|NCT02362412|"     The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of     switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet     at the equivalent total daily dose in bipolar disorder patients with major depressive     episodes.   "
70543|NCT02362399|"     To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from     growth restriction to support its use later as prolonged therapy in those pregnancies at     higher risk for such complication.   "
70544|NCT02362386|"     The objective of the study is to assess the logistical and biological feasibility of     preparing ADRCs from adipose tissue excised during standard-of-care burn wound excision using     the Celution® System for autologous, same-day application to the burn wound.   "
70545|NCT02362373|"     The investigators will conduct a prospective, seven-month pilot study to explore     pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the     levonorgestrel intrauterine system (LNG IUS) for contraception. The investigators will enroll     twenty women with well-controlled epilepsy maintained on stable anti-epileptic drugs (AED)     therapy seeking the LNG IUS for contraception. The primary outcomes are AED levels and     seizures before and after LNG IUS placement. Secondary outcomes include LNG levels, evidence     of ovulation three weeks after insertion (serum progesterone >3ng/ml), bleeding and spotting,     endometrial thickness, continuation, satisfaction and adverse events (removals, expulsions,     side effects). The investigators will conduct a baseline month assessment, insertion visit,     and follow-up visits at 21 days, three months and six months.   "
70546|NCT02362360|"     The purpose of this study is to investigate the influence of a new ostomy product on the     peristomal fit for people with an ileo- or colostomy.   "
70547|NCT02362347|"     The purpose of this investigation is to determine the effect of a weighted compression vest     in addition to usual medical care and exercise rehabilitation on cardiovascular,     neurocognitive, balance and anxiety measures in individuals medically diagnosed with, and     being treated for, a mild traumatic brain injury.   "
70548|NCT02362334|"     This study evaluates the various ocular parameters which are necessary for ocular biometry     and the calculated IOL powers using both dual Schiempflug analyzer and optical low-coherence     refelctometry.   "
70549|NCT02362321|"     Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas     are mostly based on observational studies. Here we present data from a prospective randomized     pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or     placebo for 30 days.      Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed     CSDH were recruited from a single center and randomized in order to receive dexamethasone or     placebo as a conservative treatment. Patients affected to the treatment group received oral     dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for     6 months and the rate of success of conservative treatment versus placebo was measured.     Parameters such as hematoma thickness and global impression of change were also compared     before and after treatment with chi-square tests. Adverse events and complications were     documented.   "
70550|NCT02362308|"     The investigators will test the hypothesis that endogenous aldosterone impairs insulin     secretion and insulin sensitivity in subjects with primary aldosteronism.   "
70551|NCT02362295|"     PARME study had 3 objectives:        -  To identify the specific number of incarcerated individuals with terminal illness in          need of palliative care.        -  To describe the health and penal situation of these prisoners.        -  To analyse the situation of these ill prisoners especially in the context of suspended          sentence for medical ground      In order to answer these questions, the investigators used a mixed method research.   "
70552|NCT02362282|"     Recent research in gait training for stroke survivors showed that coordinated gait components     can be best restored using the following interventions together: coordination exercises, over     ground gait training, and body weight supported treadmill training (BWSTT). These results are     important because, to the investigators' knowledge, there have been no other reports of the     restoration of coordinated gait components for those with persistent gait deficits (> 6     months after stroke). However, a remaining problem was that the restored coordinated gait     movements measured in the laboratory did not generalize for many subjects to the everyday     environment. The confluence of several factors can cause lack of generalization. First, dual     task performance (gait and cognitive attention task) can degrade both gait and attention     ability, even in healthy adults. Second, stroke can impair attention. Third, during walking     in the everyday environment, attention is required in order to safely process normally     occurring stimuli. Therefore, given the success of the new gait training protocol in the lab     setting, it is important to address the problems remaining for generalization of the     recovered coordinated gait pattern to the everyday environment. The primary hypothesis of     this study is that greater gains in gait speed will be produced by combined motor and     cognitive training versus motor training alone.   "
70588|NCT02361814|"     The objective of this pilot study is to gain observational insight into potential preventive     features of amniotic membrane transplantation in the adhesion formation after flexor tendon     repair.   "
82259|NCT02209259|"     The investigators plan a prospective randomized study to see whether negative questions     affect measures of mood, pain, or disability. A total of 175 patients will participate at     Massachusetts General Hospital.   "
70553|NCT02362269|"     The proposed study is a randomized, double-blind, controlled, multi-center clinical trial of     six months of daily oral vitamin D3 (cholecalciferol). This study will randomize 334     community-dwelling post-menopausal women of European and African descent (~167 from each     ancestry) in a 1:1 ratio between the control arm and the dosing algorithm arm using     stratified block randomization with a block size of six and stratification by site     (ancestry). The sample size of 334 includes 10% over-recruitment to allow for loss to     follow-up. The European ancestry women will be seen in the Madison clinic and the African     ancestry women will be seen in the Milwaukee clinic. The proposed study will focus on     post-menopausal women because this is the subset of the population that both Dr. Engelman's     and Dr. Binkley's preliminary data are drawn from. Moreover, 25(OH)D concentrations are     typically lower in women and in older individuals, since production of vitamin D in the skin     following sun exposure decreases with age. Therefore, this group of individuals is likely to     benefit the most from vitamin D supplementation, especially when personalized based on     biology using the proposed dosing algorithm.   "
70554|NCT02362256|"     The aim of this study is to investigate which method of naltrexone induction during rapid     opioid detoxification causes stronger stress response and has a higher influence on opioid     abstinence caused by opioid induction.   "
70555|NCT02362243|"     Purpose and Aims: The purpose of this study is to assess the clinical effectiveness of back     and core exercise interventions for low back injury prevention in firefighters. Aim 1.     Compare the effectiveness of 2 worksite exercise interventions (supervised, web-based)     relative to control to reduce lost work days related to low back injury and illness in     firefighters.      Relevance: Low back injury is one of the most common and disabling disorders in firefighters.     Thus, novel interventions are needed to counteract the adverse consequences of this disorder     and its impact on firefighter safety.      Methods: A cluster randomized controlled trial will be conducted in career, full active duty     firefighters (n = 345) who will be randomly assigned (by fire station) to 1 of 3 intervention     groups - 1) supervised exercise (n = 115), 2) web-based exercise (n = 115), or 3) control (n     = 115). Participants in the supervised and web-based exercise groups will perform back and     core exercises previously tested in our recent FEMA-funded grant (EMW-2009-FP-00418), twice     per week for 12 months while on duty, in addition to their usual physical fitness routine -     The supervised group will perform exercise under direct supervision of certified exercise     specialists, and the web-based group will utilize a web-based exercise system. The control     group will not perform back and core exercises, but will continue their usual physical     fitness routine and receive brief education on general exercise and physical activity     principles. Outcome measures include low back injury and illness data obtained and     cross-checked from various sources, other standard clinical outcome measures for low back     pain and disability, and validated physical fitness tests.      Anticipated Outcomes: We hypothesize that the supervised and web-based interventions will     reduce lost work days related to low back injury and illness by 40% compared with control.     Assuming positive results, this study will deliver an evidence-based exercise intervention     for low back injury prevention specifically designed for firefighters and assessed in a     full-scale randomized controlled trial.   "
70556|NCT02362230|"     Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in     patients with metastatic triple-negative breast cancer that have received at least two prior     treatments.   "
70557|NCT02362217|"     This study is aimed at assessing the safety of candidate Hepatitis C vaccines     AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered     separately or in combination to healthy volunteers. The study also aims to assess the     cellular immune response generated by these vaccines when administered as mentioned above.   "
70558|NCT02362204|"     Lung cancer patients experience significant physical symptoms, psychological distress and     have many supportive care needs that impact on quality of life. Implementing the role of a     Lung Cancer Nurse (LCN) is a response to meet the needs of patients and caregivers.      Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect     longitudinal patient self-assessment questionnaires at the Thoracic Cancer Centre of the     University Hospital of Lausanne.      Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and unmet     supportive care needs across three time points during the first line therapy and ii) to     explore professional acceptability of the new LCN model evaluating the perceptions of     barriers and facilitators of the model by the LCN and the other multidisciplinary members of     the comprehensive lung cancer care team.      An exact single-stage (no interim analysis) design will be applied to determine feasibility     for further studies to be undertaken. Secondary outcomes will be analyzed descriptively at     each data collection (Baseline, Time1, Time2) time point and professional acceptability will     be explored by focus groups with selected members of the interdisciplinary team.   "
70559|NCT02362191|"     Purpose: Using transcranial alternating current stimulation (tACS), the investigators will     study and attempt to treat mood dysregulation in women with premenstrual dysphoric disorder     (PMDD).      Participants: Women between ages 18-45 with a diagnosis of PMDD confirmed by participation in     a PMDD diagnostic study (IRB# 05-3000).      Procedures (methods): After a re-screening and consent appointment, eligible participants     will begin daily ratings and have baseline EEG performed during the follicular and luteal     phases. Following the luteal phase EEG, the patient will receive, in a double blind     cross-over fashion, 5 days of tACS, 40 minutes/session, performed in two successive months.     On the first and fifth days of each treatment, EEG will be performed. Patients' symptoms will     be assessed at the end of each session and with the daily mood ratings.   "
70596|NCT02361710|"     The aim of this study is determining the affects of serum vitamin D levels to implantation     and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer.     Two groups will be identified according to the serum vitamin D levels on eFET transfer day     and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared     between those groups   "
70560|NCT02362178|"     Blood products are commonly used before invasive procedures in patients with end-stage liver     diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely     INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive     procedures and in representing the real coagulation status of cirrhotic patients.     Notwithstanding they are still used to guide blood products administration before invasive     procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of     hypo-hypercoagulability possibly being an alternative method to guide blood products     transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG     as a guide for blood products transfusion in cirrhotic patients undergoing invasive     procedures.   "
70561|NCT02362165|"     Bortezomib-based triple-drug combination has greatly improved the response rate of multiple     myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in clinical     practice.Recent studies have found that cyclophosphamide, bortezomib,and dexamethasone     (CyBorD)seems better than PAD in efficacy. However, there is no randomized phase 3 trial     comparing these two regimens in the treatment of newly diagnosed multiple myeloma patients.In     this study, the investigators will compare the efficacy and safety of these two regimens     using once-weekly subcutaneous injection of bortezomib.   "
70562|NCT02362152|"     This non-interventional, multinational study of topical field treatment of actinic keratosis     (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other     topical field therapies commonly used in the individual country. Physicians will report     baseline characteristics, while the main study focus will be on patient reported outcomes 3-4     weeks after treatment completion (treatment satisfaction, adherence, resource utilization and     Health Related Quality of Life.      Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and     Canada will participate.   "
70563|NCT02362139|"     In the investigators institution, there is a wide use of Papaverine in delivery room, but     this use is optional, and is left to the discretion of the physician.      The aim of the investigators study is to prospectively evaluate the influence of Papaverine     administration in the latent phase of labor, on the duration of labor.   "
70564|NCT02362126|"     Observational prospective multicenter study to investigate efficacy and safety of endoscopic     full thickness resection in the lower GI tract using a novel over-the-scope full thickness     resection device.   "
70565|NCT02362113|"     A total of 300 adults would be included in the present cross-sectional study. glycemic index     (GI) and glycemic load (GL) would be assessed by using a validated self-administered     dish-based semi-quantitative food frequency questionnaire. Validated Iranian versions of     Hospital Anxiety and Depression Scale and General Health Questionnaire-12 would be used to     assess anxiety, depression and psychological distress.   "
70566|NCT02362100|"     The primary objective is to determine if a difference exists in functional outcomes, as     measured by the Constant score, when comparing nonoperative management and locking plate     surgical fixation of low-energy displaced proximal humerus fractures in the elderly     population over a 2-year follow-up period. Secondary outcomes will include an assessment of     the ASES score, the SF-36 quality of life score, complication rates, re-operation rates,     radiographic time to union, radiographic malunion, hardware position and evidence of     avascular necrosis or posttraumatic osteoarthritis .   "
70567|NCT02362087|"     The purpose of this study is to document what course of action physicians choose for their     patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the     greatest risk of TAPS by examining specific human genome markers such as single nucleotide     polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic     (hereditary) component.   "
70568|NCT02362074|"     The purpose of this study is to describe the impact of treatment with adalimumab on work     related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated     in Canada.   "
70569|NCT02362061|"     100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These     patients are then assigned to receive fertility treatment (ovulation induction, ICSI,     intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to     measure the junctional zone thickness and followed up after treatment to determine the rate     of implantation.   "
70570|NCT02362048|"     ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic     Pancreatic Cancer   "
70571|NCT02362035|"     This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and     pembrolizumab in hematologic malignancies.   "
70572|NCT02362022|"     Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic     stability and analgesia for surgical prosedures. This prospective, randomized, double-blind,     controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg     and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic     requirements and side effects during total abdominal hysterectomy.   "
70573|NCT02362009|"     The purpose of the Fibroid Registry is to provide a comprehensive database that captures     patient characteristics, clinical outcomes and pot-treatment quality of life measures for     patients treated for uterine fibroids. This database will serve as a platform for future     comparative effectiveness and other health services research studies.   "
70597|NCT02361697|"     This is a prospective, non-randomised, non-blinded, single center study of children and     adolescents with multiple sclerosis and clinically isolated syndrome to detect differences or     early changes in diffusion-weighted imaging (DTI) by magnetic resonance imaging (MRI).   "
70598|NCT02361684|"     To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT)     for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish     population.   "
70639|NCT02361151|"     The high rates of childhood obesity in the US demand innovative and cost-effective weight     gain prevention tools; mobile applications (apps) represent one such solution. Using a     randomized design, the mFIT study tests the effectiveness of using commercially available     apps and a physical activity (PA) monitoring device (Tech, n=50 parent-child dyads) compared     to the apps and PA device plus a mobile website and theory-based family intervention that     encourages increased parent-child communication about PA and healthy eating as well as family     behavior change (Tech+, n=50 parent-child dyads).   "
70574|NCT02361996|"     It is a common understanding that patients with coronary heart disease are suffering, among     others, from reduced myocardial perfusion. In order to increase (normalize) the reduced     perfusion, when conventional approach failed, coronary bypass surgery, coronary vessel     dilatation/stenting are performed. The similar situation with reduced myocardial perfusion     may be found in patients with stenosis of the aortic valve, where aortic valve replacement     may increase myocardial perfusion by left-ventricular remodelling. However, there is     presently no method established to measure myocardial perfusion quantitatively and     noninvasively before and after a therapeutic intervention.      Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in     ml/100g/min would strengthen the indication for specific therapeutic approach and enable an     objective control of effectiveness of the applied therapy.      Hypothesis:      There is a measureable difference in quantitative myocardial perfusion values before (lower)     and after (higher) interventional or surgical procedure.      The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT     256 Brilliance ) quantitatively in ml/100g/min in three groups of patients:        1. Before and after coronary bypass surgery        2. Before and after coronary vessel dilatation/stenting        3. Before and after aortic valve replacement.      The investigators will not assign specific interventions to the subjects of these three     groups. Therefore, the research is strictly observational.      Design:      Prospective study to measure quantitatively myocardial perfusion in the above mentioned three     groups of patients with simultaneous control and registration of all essential, physiological     determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial     perfusion measurements will be performed directly after the indication for intervention or     surgery and on the last day before discharge from hospital.      All the collected data (determinants) inclusively the CT-studies will be anonymised and     archived on a local server. The investigators of the University of Medical Computed Sciences     and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion     measurements and all statistical analysis independently of the CT-studies performing     physicians.   "
70577|NCT02361957|"     RATIONALE: The underlying etiology in inflammatory bowel diseases such as Ulcerative Colitis     is not yet fully understood. Studies suggest a relation between higher intestinal     permeability and aberrant changes of the epithelium. Dysbiosis of the intestinal microbiota     might be the cause. Probiotics may restore the balance of the intestinal microbiota. In     theory this could improve intestinal permeability and therefore reduce disease activity and     maintain remission in patients with Ulcerative Colitis.      OBJECTIVE: To investigate whether a specifically designed multispecies probiotic mixture     (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal     permeability, microbiota composition, disease activity and inflammatory markers in ulcerative     colitis.      STUDY DESIGN: 12-wk placebo-controlled randomized double-blind intervention with 2 parallel     arms.      STUDY POPULATION: Adults diagnosed with left sided Ulcerative Colitis or Pancolitis in     remission or mild stage of the disease. For inclusion of the patients the Patient Simple     Clinical Colitis Activity Index (P-SCCAI) will be used.      INTERVENTION: Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two     daily doses of 3 g of the placebo, containing only the carrier material (both produced by     Winclove Probiotics).      MAIN STUDY PARAMETERS/ENDPOINTS: Main study parameter is intestinal permeability measured by     several techniques: the lactulose/mannitol absorption test (L/M test), LPS levels in blood     serum and faecal zonulin. Secondary, inflammation will be measured from faecal calprotectin     and blood c-reactive protein (CRP) levels. Furthermore samples will be stored to measure     cytokine concentrations in serum and to analyse the microbial composition of the faecal     samples using the HITchip. For the disease related quality of life the irritable bowel     disease questionnaire (IBD-Q) and SF-36 will be used. All parameters will be measured at     three time points; t=0, t=6 and t=12 weeks.   "
70578|NCT02361944|"     The investigators will recruit and randomize 200 elective cardiac surgery patients to receive     physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery to test     the hypothesis that intraoperative physiologic oxygenation decreases the generation of     reactive oxygen species, oxidative damage, and postoperative organ injury compared to     hyper-oxygenation.   "
70579|NCT02361931|"     The investigative product, developed by Remedor, is a unique gel formulation that optimizes     the administration of EPO to the wound bed. This novel formulation has been shown to     stabilize EPO in the gel and to maintain its activity over long periods.   "
70580|NCT02361918|"     Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and     TNF-alpha for anastomotic leakage in post-operative period.   "
70581|NCT02361905|"     Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular     than the surrounding myometrium, often with crowding and overlapping of nuclei. they often     are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas.     Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as     hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer     surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably     related to degenerative changes induced by this treatment. Hypoechoic CLs should be more     responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative     ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to     GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.   "
70582|NCT02361892|"     The uterine leiomyoma is the most common female benign disease.UPA seems to be most effective     for the medical management of fibroids and could be place as preoperative adjunct to surgery     but also as medical therapy to avoid surgery. No data have been published about the effect of     UPA on FSH (Follicle stimulating hormone) or AMH levels nor on ovarian antral follicle count     (AFC) or vascularization indexes during and after treatment. Considering that in young women     of reproductive age (under 40 years old), desiring pregnancy, UPA has been proposed to avoid     or postpone surgery, also in a long-term administration program, data about its effect on     women ovarian reserve are urgently needed.      For these reasons, data on biochemical (AMH, FSH and E2) and 3D ultrasonographic (VI, Flow     index, AFC) parameters of women treated by UP are needed to assess the effect of the drug in     terms of ovarian reserve modification.   "
70583|NCT02361879|"     The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about     10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and     infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH     analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer,     but they are expensive, have potential side effects and lack a robust evidence base to     support this practice. Ulipristal acetate treatment was able and faster to control in 90% of     cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly     improved quality of life and pain reduction.   "
70584|NCT02361866|"     The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of     'GC1107' administered intramuscularly in healthy Adults.   "
70585|NCT02361853|"     Accumulating evidence suggest that the proliferative, invasive, and immune tolerance     mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the     host immune response are similar to those used by the developing placenta during normal     pregnancy. In addition to the shared capacity for invading through normal tissues, both     cancer cells and cells of the developing placenta create a microenvironment supportive of     both immunologic privilege and angiogenesis.      CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that     consist of immature myeloid cells (IMCs), and were first described as myeloid-derived     suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow     differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells     have been shown to play an essential role in mediating immune suppression in animal models of     human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been found     in peripheral blood, lymphoid organs and the tumor tissue itself. An increased population of     IMCs was identified in patients with several tumor types. Accordingly, IMCs detected in the     peripheral blood of such patients bearing express the common myeloid marker CD33 but lack     markers of mature myeloid cells such as the MHC class II molecule HLADR.      IMCs have been shown to actively promote tumor growth and metastasis by modulating the     cytokine environment, and through vascular remodeling by promoting angiogenesis.      It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice     and actively promote angiogenesis. These cells show striking similarity to IMCs that populate     malignant tumors. Accordingly, human placentas are also infiltrated by a significant     population of IMCs. Immunostaining of human placentas showed that IMCs comprise around 25% (     range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells and that this     population is located close to blood capillaries. The investigators also demonstrated that     immature DCs, cells originally described to regulate the adaptive immune response, also     promote angiogenesis in models of choroidal neovascularization, endometriosis and tumors.      Tho objective in this proposed study is to compare the abundance of IMC, DC, monocytes and     neutrophils counts in blood samples of normal pregnancies: 1. in women in term active labor.     2. In women not in labor. 3. In pre term labor.      According to our previous findings, the investigators hypothesize that IMC's, monocytes and     in active delivery (both term and pre term) will be lower than women without signs for labor.     The investigators also hypothesize that DC's and neutrophils will be more abundant in active     delivery (in term and pre term) than women without signs for labor.      Experimental plan:      Blood count will be collected from pregnant women who agree to participate in the research:      The samples will be sent for the routine complete blood count in Hillel Yaffe hematologic lab     and also will be analyzed for IMC's and DC's population in our lab using fluorescent     immunostaining with specific monoclonal antibodies and flow cytometry.      IMC's per total CD45 positive hematopoietic cells from the placental tissue will be analyzed     using fluorescent immunostaining with specific monoclonal antibodies and flow cytometry . The     specific location of these cells in the placenta will be identified within the placental     tissue using Immunohistochemistry (IHC). The expression of pro angiogenic genes will be     analyzed by RT PCR and Western blotting.   "
70620|NCT02361398|"     The investigators conducted a pilot study to compare the effect of Positive End Expiratory     Pressure(PEEP) setting guide by the highest on oxygenation and by lung electrical impedance     tomography(EIT) on survival in subjects with severe Acute Respiratory Distress     Syndrome(ARDS).   "
70586|NCT02361840|"     Shock is one of the five leading causes of income and mortality in emergencies. It generates     a decrease in the availability of oxygen to the tissues, resulting in ischemia, pulmonary     involvement and tissue reperfusion syndrome. This pathologies can trigger Syndrome of Acute     Respiratory Distress (ARDS) and death.      Troponin I (TI) has been reported as early marker for ischemia and mortality other than     coronary syndromes in critical patients.      Objective. Set the increase of TI as a predictor of ARDS in children with shock.      Null hypothesis. Increase serum in children with shock predicts the onset of ARDS.      Methodology. Prospective cohort type test diagnostic. Displays institutional. Sampling     non-probability, consecutive inclusion. Calculation of the sample size: interval of     confidence (IC) 95%, power - 80%; ratio non-exposed: exposed 2:1; n = 62.      Inclusion criteria: informed consent signed by the parent; children admitted to pediatric     emergency (PEU) 1 month to 14 years with shock requiring mechanical ventilation.      Exclusion criteria: intake of toxic (TI value increment per will), ≥3 concentrated     erythrocyte transfusion or plasma prior to entering PEU.      The investigators call exposure to the increase of TI≥0 05ng/ml and event to the development     of ARDS. Determine TI value in plasma serum in the first 24 h, through Enzyme Immunoassay for     the Quantitative Determination of Cardiac-Specific Troponin-I in Human Serum (cTnI ELISA),     (reported as cardiac triage). Monitoring for 7 days.      Study was approved by Hospital Ethics Committee (Research record 003/12)   "
70884|NCT02357966|"     This study will evaluate the maximum safe dose of the true human monoclonal antibody, 514G3,     in the treatment of patients with Staphylococcus Aureus bacteremia. Preliminary evidence of     efficacy will be evaluated as well. Patients will receive 514G3 plus antibiotics or placebo     plus antibiotics in approximately a 3 to 1 ratio.   "
70589|NCT02361801|"     Inotropic agents are usually administered in the postoperative period after cardiac surgery.     In most cases, dobutamine is administered routinely, for the probable occurrence of     myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal     evidence of altered tissue perfusion.      Recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the     perioperative period. However, the use of inotropic agents may be associated with adverse     events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the     imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus     tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect.      This study is a non-inferiority clinical randomized study aiming to compare the use of     dobutamine in a liberal strategy (in all patients at the time of withdrawal of CPB) with a     restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output     syndrome associated with altered tissue perfusion). Our primary hypothesis is that the     restrictive use of dobutamine is as safe and effective as the liberal one.   "
70590|NCT02361788|"     Background:      Neonatal hyperbilirubinemia is the most common reason for admission in the neonatal period     (first month of life) worldwide and at SMRU. The skin of the newborn baby becomes jaundiced,     which is caused by a high level of bilirubin in the blood. In some neonates the level of     bilirubin increases to a level that can cause braindamage or even death. There are different     causes known that can lead to higher levels of bilirubin, for example G6PD deficiency and     prematurity. In case of neonatal hyperbilirubinemia the neonate needs to be treated with     phototherapy (blue light therapy). If there is prolonged jaundice (≥ 21 days), further     investigations needs to be done.      Objectives:      Primary objective:      To determine the etiology of neonatal hyperbilirubinemia in neonates with a gestational age     of ≥ 28 weeks from the refugee and migrant population, on the Thai-Myanmar border.      Secondary objective:        -  Establishing the incidence of neonatal hyperbilirubinemia        -  Determine the risk factors for the development of neonatal hyperbilirubinemia        -  Determine the incidence of prolonged neonatal jaundice        -  Determine the neurodevelopmental outcome, at the age of 6 and 12 months        -  Determine the body composition, using air-displacement plethysmography, at birth, 1, 2          and 3 months of age        -  Determine the incidence of anaemia and illness episodes during the first year of life        -  Determine the incidence of helminthic infection at the age of one year        -  Assess the knowledge level and misbeliefs on neonatal hyperbilirubinemia among the          mothers and SMRU health care staff      Research design:      The study will conduct an exhaustive prospective descriptive study, all eligible newborns     will be enrolled after obtaining the informed consent from their mothers. During pregnancy     and delivery we will collect clinical data about the mother. At birth we will take umbilical     cord blood (9 ml) to test for different causes of neonatal hyperbilirubinemia. In the first     week of life we plan 4 moments to measure the bilirubin and hematocrit level (0.05 ml),     weight and ask questions about feeding and other practices. Based on the bilirubin results we     will determine whether the neonate needs phototherapy. After the first week we weekly     follow-up will be conducted and in case of visible jaundice we will measure the bilirubin     level. If the neonate is still jaundiced after the age of 21 days we will further investigate     the cause. In the infant period, until the age of one year, we plan to have monthly follow-up     to assess the health and growth of the child and at the age of 3, 6 and 12 months we will do     a neurodevelopmental test.      An improved understanding of the pathological processes contributing to the development of     neonatal hyperbilirubinemia is needed in order to to identify neonates at risk and develop     improved management.   "
70591|NCT02361775|"     Level I randomized prospective outcomes study comparing two groups of patients. One group     will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will     receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with     an infusion of 0.2% Ropivicaine post-operatively and a PCA.   "
70592|NCT02361762|"     The goal of the project is to better understand executive control—how children manage complex     or conflicting information in the service of a goal. This skill has been linked to social and     academic functioning in typically developing children. Executive control is often reduced in     children with autism spectrum disorders, but it has not been a focus of treatment. This     project will have the goal of determining whether computer-training tasks developed to     enhance the executive control skills of preschoolers and school-aged children without autism     are appropriate for children with ASD. The investigators do not yet know if this training is     beneficial for children with ASD. In addition, because executive control has been found to     relate to social knowledge and problem solving, the investigators will collect information     with this type of task to measure possible effects of training.   "
70593|NCT02361749|"     Chronic idiopathic constipation is most common cause of Constipation in childhood with     numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical     options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin.     Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of     Idiopathic Constipation   "
70594|NCT02361736|"     Hydroxyethyl starch (HES) is commonly used as plasma expander during surgery but may be     nephrotoxic as seen in studies in patients with sepsis. The investigators hypothesized that     the possible nephrotoxicity of 6% HES 130/0.4 could be revealed by measurements of urinary     and plasma neutrophil gelatinase-associated lipocalin and interleukin-18 (IL-18) in old     patients with normal renal function during orthopaedic surgery.   "
70599|NCT02361671|"     Elevated intracranial pressure (ICP) is a common and potentially life threatening condition     arising from a variety of pathological conditions. The ability to monitor ICP is a crucial     aspect in the management of these patients. Currently, the diagnosis of whether ICP is     elevated or not is determined either with clinical signs (headache, nausea and vomiting or     visual disturbances) or from the changes in the preoperative neuroimaging modalities such as     computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).      Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam     that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in     the optic nerve sheath diameter (ONSD).      The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients     with intracranial pathology and to compare the changes in the ONSD before and after surgical     intervention as well as between patients with and without clinical or radiological signs of     increased ICP.   "
70600|NCT02361658|"     Elevated intracranial pressure (ICP) is a common and potentially life threatening condition     arising from a variety of pathological conditions including traumatic brain injury (TBI),     intracranial hemorrhage, subarachnoid hemorrhage and brain tumors. Monitoring the ICP is the     most important aspect of the management of these patients. Recently, transorbital     ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be     useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath     diameter (ONSD). Transorbital ultrasonographic measurement of ONSD appears to be a     noninvasive, relatively inexpensive bedside examination for the diagnosis of raised ICP. The     investigators aimed to determine the changes in ONSD with acute controlled changes in ICP in     healthy volunteers. The controlled changes in ICP will be produced by manipulating the PCO2     with the use of Respiract and jugular venous compression with the use of custom made neck     collar.   "
71953|NCT02343939|"     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of     entospletinib (GS-9973) when administered as monotherapy or in combination with chemotherapy     in adults with acute myeloid leukemia (AML).   "
70601|NCT02361645|"     The purpose of this study is to assess vitreous concentrations of nonsteroidal     antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before     vitrectomy.      A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the     beginning of the surgery before infusion with balanced salt solution. Samples were     immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked     fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase     liquid chromatography mass spectroscopy system. The minimum quantification limit for     ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations     were determined using a commercially available competitive enzyme immunoassay kit (R & D     Systems, Minneapolis, MN).   "
70602|NCT02361632|"     The intention of this study is to determine wether coffee added milk change gastric volume in     comparison with gastric volume after drinking black coffee   "
70603|NCT02361619|"     Four periods of oral dosing following overnight fasting (1. known metabolic probe drug     cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2.     dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail +     dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods.     Adverse events, haematology and clinical chemistry recorded.   "
70604|NCT02361606|"     Adolescents are often reluctant to receive psychological help. The investigators developed a     web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes.     The investigators aimed to examine the participation rate and outcomes on glycemic control     and quality of life.   "
70605|NCT02361593|"     The aim of this study is to evaluate efficacy and safety of transparent cap-assisted     endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.   "
70606|NCT02361580|"     Primary null hypothesis:      • Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS     [Patient Reported Outcome Measurement Information System] upper extremity) 8 weeks after     injury.      Secondary null hypotheses:        -  Keeping a personal diary has no effect on avoidance of painful activities (assessed w/          PROMIS pain interference) 8 weeks after injury.        -  Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS          depression) 8 weeks after injury.        -  There are no factors associated with upper-extremity disability 8 weeks after injury.   "
70607|NCT02361567|"     Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of     discharge following mild to moderate pain risk surgery. The following will be assessed: 1)     Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3)     Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat     opioid prescription. It is expected that both groups will have similar pain outcomes but     those patients in the Percocet group will be more likely to seek a second prescription.   "
70608|NCT02361554|"     The purpose of this pilot study is to investigate the use of deep brain stimulation (DBS) of     the substantia nigra pars reticulata (SNr) in subjects with treatment-resistant     schizophrenia. There is a subset of patients with schizophrenia who continue to have     persistent psychotic symptoms (auditory hallucinations and delusions) despite multiple     adequate medication trials with antipsychotic medications including clozapine. There are     currently no available treatments for such patients who generally have poor function and are     chronically disabled, unable to work, live independently or have meaningful social     relationships. Neuroimaging studies in patients with schizophrenia have revealed information     about pathological neural circuits that could be suitable targets using deep brain     stimulation. Although not yet tested in patients with schizophrenia, DBS is in early phase     clinical trials in other psychiatric disorders.      This pilot study will investigate the use of DBS in treatment-resistant schizophrenia     subjects who have exhausted all other therapeutic alternatives but continue to have     persistent disabling psychotic symptoms. Of note, DBS is not FDA approved for use in patients     with schizophrenia. The method will be similar to that used in subthalamic nucleus     stimulation in patients with Parkinson's Disease. However, the electrode will be advanced     slightly inferior into the SNr, a major outflow nucleus of the basal ganglia, with the     intention of causing local inhibition of SNr outflow resulting in disinhibition of the     mediodorsal nucleus (MDN) of the thalamus. Hypofunction of the MDN has been implicated in the     pathophysiology of schizophrenia in post-mortem as well as multiple structural and functional     imaging studies. Evidence suggests that dysfunction of the MD is implicated in both positive     and cognitive symptoms (such as working memory impairment) in schizophrenia. Frequent     monitoring and clinical assessment with psychiatric scales will be used to monitor treatment     response.   "
70633|NCT02361229|"     It's known that organ transplant recipients with long-term drug-induced immunosuppression     have a increase of the life-time incidence of squamous cell carcinoma. This study will     analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the     association with exposure to immunosuppressive and antiinfective drugs and other parameters     like age or gender of organ transplant recipients.   "
70609|NCT02361541|"     Hepatitis C (HCV) is an important global public health problem, disproportionately affecting     HIV positive populations. Asia and Africa account for most of the co-infection burden, but     access to HCV screening and treatment is still very limited. It is expected though, with the     recent therapeutic advances and increasing global advocacy efforts, that HCV treatment should     become a feasible option in the near future.      Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest     HIV cohorts of the country, followed in an ambulatory settings. In this cohort, the     prevalence of HCV co-infection will be determined, as well as HCV genotype diversity and the     severity of liver disease. The researcher will also explore the performance of simple blood     tests/panels as predictors of significant fibrosis and/or cirrhosis.      Patients will attend two study-visits. All adult patients of the HIV patient cohort of SHCH     will be proposed HCV testing during their next HIV follow-up consultation, following the     latest algorithm of the Centre for Disease Control (CDC) (May 2013). Anamnesis and clinical     examination will focus, additionally to routine practice, on presence of general and HCV     liver-disease related features. Laboratory analyses will include basic HIV tests (CD4), and     tests for liver function such as Hepatitis B surface antigen (HbsAg) .      During the following routine HIV follow-up consultation, the results of HCV testing will be     explained to the patient. If the patient is HCV negative, his/her study participation ends     here. If currently infected with HCV, the clinician will repeat the HCV liver-disease     (extra-hepatic & hepatic) related anamnesis and clinical examination, and prescribe     additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests, liver     and kidney function. Patients will moreover be asked to undergo a liver ultrasound and liver     stiffness measurements.   "
70623|NCT02361359|"     Psychologic status is associated with poor outcome after joint arthroplasty and perhaps     chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific     disorders or pain-related beliefs that contributed to chronic pain should be identified. We     therefore determined whether specific psychologic disorders (depression, anxiety disorder) or     health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain     after joint arthroplasty for osteoarthritis.   "
71035|NCT02355964|"     This project aims to study the effects of lifestyle changes on asthma and systemic     inflammation in a randomized clinical trial of diet and exercise. The project is a     multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred     on improving asthma control in non-obese sedentary asthmatics via simple means.   "
70610|NCT02361528|"     The concept of acquired immunodeficiency after a first severe infection in the ICU is widely     described in the literature. There is a dual risk: increased mortality and increased     secondary infections. Several approaches of immunostimulatory treatments have been proposed     in the literature. The treatment proposed by this study consists of the administration of     Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely     used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in     Germany in 2009.      The main objective is to measure the incidence of ICU-acquired infections in 2 groups of     patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3     from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The     detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human     Leucocyte Antigen DR)with a threshold of less to 8000 sites.      Our hypothesis is that the number of secondary infections (primary endpoint) will be     significantly reduced in the treated group.   "
70611|NCT02361515|"     The present randomized, open, multicentric Phase II trial, in parallel groups with two arms     of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to     treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space     between the prostate and the rectum to preserve the rectal-wall from high doses of     irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2     induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a     stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after     an injection of hyaluronic acid between the rectal wall and the prostate.      Ninety-six patients and 9 centers are included in the protocol.   "
70612|NCT02361502|"     The proportion of male patients who participated in the phase III study of mirabegron was     about 28% and the data on the efficacy and safety of mirabegron in Korean male OAB patients     have limits. For this reason, this study will assess the efficacy and safety of mirabegron in     Korean male OAB patients.   "
70613|NCT02361489|"     The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or     basal insulin with oral agents can be efficiently and safely started with meal time insulin     using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go)     using one of two dose titration algorithms to achieve improved A1C at 4 months.   "
70614|NCT02361476|"     Clonidine is widely used off-label in children for several indications. Clonidine is used for     treatment and/or prevention of postoperative agitation in children anaesthetised with     Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators     don´t have data for characterization of the pharmacokinetic profile among age-groups for     children 1-6 years.      In this study the investigators want to investigate if IV Clonidine administered at the end     of surgery can prevent/reduce postoperative agitation. Secondary outcomes include     measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.   "
70615|NCT02361463|"     Laparoscopy training programs with virtual reality simulators are widely used before new     surgeons are allowed to operate on patients. Laparoscopic surgery results in shorter time to     recover, less surgical trauma and thereby a shorter stay at the hospital compared with open     surgery. However, it is more difficult to learn laparoscopic surgery, than open surgery, in     part because surgeons have to work in a 3-dimensional space, through a 2-dimensional     interface on a screen. This results in loss of depth perception and therefore a higher visual     and cognitive load. This trial examines if using 3D vision instead of 2D vision on the     laparoscopic virtual reality simulator reduces the time to reach proficiency, by decreasing     the cognitive and visual load during practice on a Virtual Reality Simulator.   "
70616|NCT02361450|"     Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the     embryonic neural tube, leading to serious malformations of the nervous system. Caudal     neuropore malformations almost always lead to sensory-motor deficits (including complete     paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological     dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).      The purpose of the study is to assess the efficacy of retrograde colonic irrigation     associated with usual care (medical treatments, patient education) on anorectal dysfunction     (incontinence and/or constipation), compared to usual care only.   "
70617|NCT02361437|"     This study is designed to evaluate if Vasculera, a marketed medical food product, will     improve the rate and extent of healing of diabetic ulcers.   "
70618|NCT02361424|"     The purpose of this study is to assess the safety and efficacy on cognitive impairment and     functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen     at low dose) in patients with mild Alzheimer Disease.   "
70619|NCT02361411|"     The purpose of this study is to        1. Early identify patients based on clinical manifestation, imaging, gene and histology,          explore diagnostic tools        2. get gene repertoire of Chinese        3. Build a cerebral amyloid angiopathy (CAA) prospective cohorts, observing the disease          history, and exploring prognostic factors of hemorrhage in CAA patients   "
70621|NCT02361385|"     The importance of the detection of early inflammatory arthritis is recognised as being     essential to the prevention of permanent joint damage. Furthermore, drug development in     inflammatory arthritis is in increasing need of imaging that is able to sensitively and     accurately detect and quantify inflammation in a reproducible and objective manner. There is     an increasing body of evidence to support the role of PET-CT for these indications. The PET     tracer 11CPBR28 is specific to the translocator protein (TSPO) highly expressed on activated     macrophages. In this proof of principle study, the investigators aim to ascertain whether or     not the PET tracer 11CPBR28 is taken up in inflamed joints. The investigators also aim to     explore the significance of TSPO to inflammatory arthritis, through blood and joint lining     samples.   "
70622|NCT02361372|"     In a controlled, parallel, double-blind intervention study over 6 months, the investigators     investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium     bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and     compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured     in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at     the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry     (DXA) at baseline and at 6 months.   "
70624|NCT02361346|"     This Phase I, multiple ascending dose study will seek to enroll subjects with progressive B     cell non-Hodgkin's lymphoma with measurable disease (lesion > 1.5 cm) (including SLL) OR     relapsed/refractory B-cell CLL who have received standard treatment with at least one     anti-CD20 antibody (e.g.; rituximab, ofatumumab)) containing front-line regimen that resulted     in initial response, followed by relapse/recurrence and who are not eligible for any further     approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or refuse     alternative approved therapies and/or are unlikely to achieve clinical benefit from any     therapy of higher priority by Investigator assessment.   "
70625|NCT02361333|"     The purpose of this study is to determine whether a teaching intervention can help increase     the use of remote monitors in patients with implantable cardioverter defibrillators.   "
70626|NCT02361320|"     The goal of this study is to learn if computed tomography (CT) scans can help researchers     predict how patients with pancreatic cancer may respond to chemotherapy.   "
70627|NCT02361307|"     The outcomes of ADL training in stroke patients depend on multifactors and essential     practical point is cooperation plus effective communication between occupational therapist     and nurse.   "
70628|NCT02361294|"     The study is designed to evaluate the role of platelets and immature platelets in the     ethiopathology of deep venous thrombosis and pulmonary embolism.   "
70629|NCT02361281|"     Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath,     chest pain and reduced lung function. Suffering from these diseases has a very negative     effect on the quality of life. When people are suspected of having sarcoidosis various     markers in the blood are measured. Ultimate diagnosis, however, always requires invasive     techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a     new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for     the patient.      Such a new diagnostic tool might be found in examining the exhaled air of patients, which     contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result     of damaging processes that occur in the lung. Determining the VOC profile in the breath can     be used as a biomarker, or biological indicator, of those damaging processes. In other words,     searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the     development of a diagnostic tool that only uses their exhaled breath.      The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this     study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous     study, sarcoidosis-specific VOCs were found, which we intend to validate using the current     study.   "
70630|NCT02361268|"     The purpose of this study is to compare the effects of intra-dialysis yoga to an educational     program among patients with end-stage renal disease. The investigators hypothesize that yoga     as compared to the educational program will significantly improve quality of life.   "
70631|NCT02361255|"     Parkinson's disease (PD) and Drug-induced Parkinsonism (DIP) can be clinically     indistinguishable and DIP sometimes represents unmasking of underlying PD. The objective of     this study is to determine the relationship of underlying Parkinson's disease (PD) to the     incidence and clinical outcome in DIP using non-motor assessments as a marker for     nigrostriatal degeneration.      Research Design: This is a nested case-control design to investigate risk factors associated     with the development of DIP and persistent Parkinsonism after antipsychotic (AP) withdrawal     (a potential clinical marker of underlying PD). Target enrollment is 45 subjects.      Methodology: We will examine objective olfactory function (via objective olfactory testing),     other non-motor symptoms of PD (via standardized validated questionnaires), and motor     findings (via clinical exam and quantitative gait analysis) in: 1) DIP patients (30 subjects)     compared to AP-treated patients without Parkinsonism (15 subjects) and 2) patients with     persistent Parkinsonism compared to those whose symptoms resolve in the DIP cohort followed     prospectively after a change in AP treatment. Additionally, in patients where it was     performed clinically, we will evaluate dopamine transporter SPECT imaging (DaTI) as a marker     of nigrostriatal integrity examining the ability of qualitative and semi-quantitative     analysis to distinguish between pharmacologic and degenerative Parkinsonism. We will also     measure serum uric acid and Apolipoprotein A1, two putative biomarkers in early PD, and     examine their relationship with clinical and radiologic status.   "
70632|NCT02361242|"     PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03     protocol) and is designed for the descriptive analysis of patients with mild AD who are     exposed to PXT00864 over an additional 24-week period.   "
70640|NCT02361138|"     SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an     insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose     study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in     healthy subjects.   "
70641|NCT02361125|"     The goal of this clinical research study is to evaluate the effectiveness of ritalin     (methylphenidate) taken on an as needed basis for the management of cancer related fatigue.     The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers     will also evaluate the level of fatigue throughout the day and any possible causes of     fatigue.   "
70642|NCT02361112|"     Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This     study is designed to evaluate the safety and tolerability of Pyrotinib in combination with     capecitabine in patients with HER2 positive metastatic breast cancer:      To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To     determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of     Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for     phase II study   "
70643|NCT02361099|"     This is a study that evaluates an optimization of the monitoring of patients with lung cancer     in order to extend the survival of patients by improving their quality of life and decreasing     anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up     imaging also helps to reduce the cost of such monitoring. The main objective of this study is     to evaluate the overall survival of patients.   "
70644|NCT02361086|"     The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics     and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17,     in patients with castration-resistant prostate cancer (CRPC).   "
70646|NCT02361060|"     Pulmonary complications are relatively frequent after surgery, and can be associated with an     increase in morbidity and mortality. Although there are several causative mechanisms that can     lead to postoperative pulmonary complications, alterations in the shape and motion of the     chest wall are of primary importance.      In the investigator´s institution the incidence of postoperatory hypoxemia defined as     pO2/FiO2 <300 is over 20% for patients after major abdominal surgery.      Observational and randomized clinical trials have demonstrated that incomplete neuromuscular     recovery during the early postoperative period may result in acute respiratory events     (hypoxemia and airway obstruction) and an increased risk of postoperative pulmonary     complications.      A recent study in laparoscopic bariatric surgery showed that patients in which neuromuscular     block reversal was done with sugammadex had less chest X-ray pathological changes than those     from an historical cohort reversed with neostigmine.      The hypothesis is that differences in pulmonary complications, as atelectasis and hypoxemia,     between patients reverted with sugammadex or neostigmine may be more apparent with more     sensitive techniques like spirometry or lung ultrasound when they exist.      Lung ultrasound (LUS) has demonstrated a sensitivity of 90% and a specificity of 98%, to     detect alveolar consolidation in critical ill patients while chest radiography data are known     to be imprecise.The investigator would like to explore the utility of LUS in postsurgical     patients and the relationship between degree of hypoxemia and consolidation area.      Objectives:        1. Primary: Forced vital capacity decreases after surgery. This reduction may be relieved          in the absence of residual neuromuscular block. Objective is to assess differences after          reversal with neostigmine versus sugammadex in:           • Forced vital capacity (FVC)        2. Secondary objectives: To assess differences after reversal with neostigmine versus          sugammadex in:             -  Atelectasis size determined by lung ultrasound (Plannimetry)             -  pO2/FiO2 <300 1 hour after surgery             -  Explore the accuracy of lung ultrasound (LUS) to diagnosis postoperative               atelectasis and its correlation with chest Xray, FVC and pO2/FiO2.      Hypotheses:        1. Sugammadex NMB reversal results in a lower reduction of forced vital capacity (FVC) as          compared to NMB reversal with neostigmine.        2. Atelectasis is common after major surgery. Size of atelectasis determined by lung          ultrasound planimetry is lower one hour after sugammadex reversal as compared to the          neostigmine group.        3. The incidence of post-surgical hypoxemia is lower in the sugammadex group as compared to          the neostigmine group (Hypoxemia defined as pO2/FiO2 less than 300 is expected in 20% of          patients after major abdominal surgery).        4. Lung ultrasound has a better capacity to detect alveolar consolidation than Chest Xray          after major surgery.        5. Atelectasis size determine by planimetry has a good correlation with pO2/FiO2 and          decrease of FVC after surgery   "
70647|NCT02361047|"     This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a     parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers     of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.   "
70648|NCT02361034|"     This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.   "
70649|NCT02361021|"     Evaluation of lung aeration during weaning from mechanical ventilation determined by     electrical impedance tomography and lung ultrasound   "
70650|NCT02361008|"     The purpose of this study is to investigate the security and validity of transesophageal     echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in     treatment of infundibular ventricular septal defect(IVSD) with asymmetric occluder.   "
70651|NCT02360995|"     The objective of this clinical research study is to evaluate clinical efficacy of Colgate     Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash,     and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis     and dental plaque in adults in a six-week clinical study.   "
70652|NCT02360982|"     The aim of this study is to compare the risk factors and the incidence of delirium following     orthopedic surgery under the general or regional anesthesia in elderly patients.   "
70653|NCT02360969|"     Strabismus is a common condition (4-6% of the population) . The screening and treatment is a     public health issue. Indeed, beyond the disfigurement, this disease is very supplier of     amblyopia which is definitive if it is not detected and treated early (before 6 years old).      Initial treatment of strabismus is medical with orthoptic reeducation through penalization of     the better eye in case of amblyopia or wearing optical correction in case of associated     refractive disorder.      The second step is the treatment of strabismus is the surgery, when medical treatment has not     resulted in a recovery of the visual axes. The principle of surgery is to weaken or     strengthen one or more extraocular muscles of one (or two) eye to correct the eyes squint     deviation. The main difficulty of surgical treatment is to assess the amount of strengthening     or weakening muscles to do in order to obtain the best result and for a long time.      The investigators know that the postmortem anatomical position of the eyes is generally a     slight elevation and divergence, but is inferior to the angle of divergence of the orbital     axes. Curare and similar products which inhibit the nervous transmission at the neuromuscular     junction, can be used to reproduce this situation in normal subjects.      The sign of general anesthesia is then to evaluate the angle of strabismus when the patient     is under deep general anesthesia and with a complete muscle relaxation, obtained only when     curarised it. If one or both eyes are recovering under general anesthesia, strabismus is     mainly due to dynamic changes and surgery limiting muscle play (wire operation) and sometimes     one eye is justified. A combination of both is possible (down + wireless), guided by the     importance of the sign of general anesthesia on two prominent eyes or one eye. This sign of     general anesthesia is however less known and most poorly quantified in healthy subjects. Yet     it seems very important to determine what is deviation in normal subjects after neuromuscular     blockade, as his eye movement is also subject to mechanical factors and spastic. This would     indicate whether the state of rectitude (no strabismus) is the result of a deviation at     complete rest (appearing under general anesthesia) and corrected by spastic elements     wakefulness or, in another case this righteousness is already present in the state of general     anesthesia (due to static factors) and slightly modified by enlightenment.   "
70654|NCT02360956|"     The purpose of this study is to determine whether olmesartan medoxomil is effective in the     treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume     reduction in patients with coronary atherosclerosis detected by coronary CT     angiography(CCTA).   "
70655|NCT02360943|"     The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is     based on anticoagulants. During the last decade, all the randomized clinical trials     evaluating these anticoagulants have included PE patients with an average age below 60 years.     But in clinical pratice, approximately 50% of PE patients are older than 75 years.      So the investigators want to perform a french multicentre prospective cohort of consecutive     patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the     validated and available anticoagulant treatments are authorized in this cohort     (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and     direct oral anticoagulants).      This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and     regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these     anticoagulants in this older population. Using population approach modelling , the     investigators will pay particular attention to the sources of PK/PD variability PK / PD such     as genetic polymorphisms of P-glycoprotein and cytochrome P450.      Using all these data , the investigators will try to identify significant risk factors for     bleeding and venous thromboembolic events.   "
70656|NCT02360930|"     The trial is to determine if a difference exists in the way that adolescents and young adults     metabolize the chemotherapy agent vincristine compared to younger children.   "
70657|NCT02360917|"     At Cedars-Sinai Medical Center, we have developed a novel curriculum for a 6-week     psycho-educationally-based, cognitive behavioral program to help patients with subjective     cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each     series meets once a week for 2 hours for 6 weeks. The leading neuropsychologist covers     material such as guided relaxation, behavioral strategies for automatic/negative thoughts,     compensatory strategies for attention and memory, executive functioning, pacing, and balance.     Each Haze series will be electronically delivered in a live format to our satellite site, The     University of Kansas.   "
70658|NCT02360904|"     The primary aim of this study is to assess and compare change in QOL during chemotherapy as     measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between     patients receiving yoga and those not receiving yoga. Secondary endpoints will include other     measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory     (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and     adherence to yoga and to chemotherapy treatment.   "
70659|NCT02360891|"     Amyotrophic lateral sclerosis (ALS) is a complex polymorph and devastating neurodegenerative     disease. Although the pathophysiological mechanisms underlying the development of ALS remain     to be fully elucidated, there have been significant advances in the understanding of ALS     pathogenesis, with evidence emerging of a complex interaction between genetic factors and     dysfunction of vital molecular pathways. However, the numerous randomized clinical trials     (RCT) for ALS have failed to generate improved drug treatments. Biomarkers able to bring     prognostic value and to distinguish the different endophenotypes of this polymorphic disease     could help to better select clusters of patients in order to improve the RCT outcomes.     However, little progress has been made in the development of viable diagnostic, prognostic     and monitoring markers. This could be explained by common shortcomings, such as relatively     small sample sizes, statistically underpowered study designs, lack of disease controls and     poorly characterized patient cohorts. It is yet crucial that the investigators further     develop and validate ALS biomarkers and incorporate these biomarkers into the drug     development pipeline for ALS.      The aim of the present study is therefore to determine the clinical, biological, imaging, and     electrophysiological biomarkers of prognosis of survival without events (i.e. severe     comorbidity, 24 hours of non invasive ventilation, tracheotomy). This is a prospective     observational multicentric French study of a cohort of 1000 ALS patients.      This large multimodal database will be open for international fruitful scientific     collaborations.   "
70660|NCT02360878|"     We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose     metabolism as well as gut and pancreatic hormone secretion.   "
70661|NCT02360865|"     1: Is endothelium function impaired in COPD? Other chronic cardiovascular diseases are     associated with endothelial dysfunction, and the endothelium plays an important role in     regulating vascular tone, tissue blood flow, coagulation and the inflammation process.     Although the specific causes of endothelial dysfunction remain unclear, physical inactivity,     chronic systemic inflammation and smoking are all known to be associated with endothelial     abnormality.      2. Is Muscular Sympathetic Nerve Activity (MSNA) increased in COPD? A balanced regulation of     blood flow to skeletal muscles may be disturbed by pathophysiology and may therefore     contribute to the exercise intolerance and skeletal muscle depletion seen in patients with     COPD.Skeletal muscle blood flow is tightly regulated to match tissue oxygen demands and is     thus adapted to meet energy requirements. During physical activity, the sympathetic nervous     system is activated (exercise pressor reflex), resulting in increased ventilation, heart     rate and a redistribution of cardiac output from inactive to active tissues. The     redistribution of cardiac output to the body organs is heterogeneous. Blood flow to skeletal,     respiratory and cardiac muscle increases as exercise intensity increases, whereas blood flow     to gastrointestinal, renal and reproductive tissues decreases. As blood pressure during     exercise remains largely unchanged, the redistribution of blood flow is caused by changes in     vascular conductance. These conductance changes are caused by an overall vasoconstriction     induced by the increased sympathetic outflow of noradrenaline (NA), and a vasodilation of     vascular beds supplying the working skeletal -, cardiac- and respiratory muscle.   "
70662|NCT02360852|"     This study will evaluate the safety, tolerability and influence on itching, bile acids and     liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250   "
70663|NCT02360839|"     Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle     biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and     intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma)     are often well characterized by cytology assessment of FNA-samples while others are not (such     as GIST-tumors).      This study is a part observational (early study phase) and part interventional study (late     study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during     a 10-year period on a tertiary endoscopy centre.   "
70664|NCT02360826|"     Anticipating an increased use of statins in children and adolescents, it is imperative that     we understand the genetic and developmental characteristics affecting the pharmacokinetics     and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric     dosing guidelines from adult dose-exposure-response relationships fails to recognize the     potential impact of growth and development in pediatric patients, which may have important     clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic     variation in the SLCO1B1 transporter is important for statin disposition and toxicity in     adults. The ontogeny of SLCO1B1 during human growth and development has not been well     characterized, and limited pediatric data indicate that the genotype-phenotype relationship     in children is the opposite of that observed in adults. Therefore, investigating the relative     roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response is key to     determining the age at which the statin dose-exposure-response relationship mimics adults,     and has important implications for other medications transported by the SLCO1B1 protein.      As the first step in this process, our specific aims for the current investigation are 1) to     determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin     and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with     2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine     if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC     and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary     aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and     adolescents for each genotype group. These results will be utilized to determine the sample     size necessary to adequately power future studies characterizing the role of ontogeny on     statin disposition.      The ultimate goal of this proposed investigation is to establish the role of genetic     variation in key transporters on the dose-exposure relationship of two commonly used statin     drugs in children. This study is the first step in a series of investigations aimed at     determining the mechanisms behind variations in physiologic response, clinical efficacy and     significant adverse effect risk that surround the statin drugs in children and adolescents.   "
70665|NCT02360813|"     This clinical trial tests the feasibility, effectiveness and patient satisfaction with     cognitive remediation therapy for patients diagnosed with schizophrenia or schizoaffective     disorder within a forensic hospital. It is hypothesised that patients receiving cognitive     remediation therapy will have an improvement in cognitive performance, real world     functioning, symptoms, violence risk and benefit more from additional psychosocial treatment     programmes over time relative to patients receiving treatment as usual. Furthermore it is     hypothesised that it will be feasible to carry out such a study and that patients will report     high rates of satisfaction with cognitive remediation therapy. Finally it is hypothesised     that differences on the effectiveness measures will be maintained at 6 month follow up after     the end of treatment.   "
70666|NCT02360800|"     Bleeding after ascending aorta surgery is a common, unresolved and consequences-heavy event     as per present day. Tisseel (Baxter inc) sprayed on the already hemostased mediastinum jut     before closing seems a promising technique to radically diminish bleeding.      This study aims to verify this efficacy (expected goal -50% blood volume in chest drains) and     possibly the consensual blood transfusion lessening.   "
70667|NCT02360787|"     The purpose of this study is to determine whether inclusion of almonds in a weight loss     regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio     of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive     function.   "
70668|NCT02360774|"     The purpose of this study is to investigate the effect of canagliflozin, a medication     approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in     people with type 2 diabetes who are overweight or obese.      Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than     absorb, glucose. Canagliflozin is also often associated with weight loss.      The study population will generally be type 2 diabetics, ages 18-75 years old, who are     overweight or obese.   "
70669|NCT02360761|"     The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm)     early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is     being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these     trials is under-represented, as in most of the ongoing clinical trials. This study focuses on     the elderly population of early stage lung cancer, and aims to investigate the outcome of     lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC)     in elderly patients.   "
70670|NCT02360748|"     The study proposes that addition of high protein plant based diet will improve serum albumin     as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Peritoneal     Dialysis. Patient will be provided additional food items to help improve their nutritional     status.   "
70671|NCT02360735|"     Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease     various forms of edema. This technique promotes reuptake of interstitial fluid along the     pathways of the lymphatic system. This technique promotes healing, decrease swelling, and     decrease pain.   "
70672|NCT02360722|"     This is a single- country, interventional, double-arm study involving Chinese Elderly     subjects.   "
70673|NCT02360709|"     The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8     sirolimus-eluting stent system in the treatment of patients with de novo coronary artery     lesions.   "
70674|NCT02360696|"     Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have     previously described the finding of duodenal mucosal eosinophilia in 71-79% of children     undergoing diagnostic endoscopy. Previous studies in children have shown positive response to     montelukast with approximately 50% finding complete relief and 20-30 percent showing no     response.      There are a number of factors that have the potential to contribute to the observed     variability in response to montelukast. These include variability in:        1. systemic drug exposure (drug absorption, biotransformation and/or elimination)        2. regulation of leukotriene biosynthesis        3. cysteinyl leukotriene receptors and downstream mediators        4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease          classification, psychologic profile)      In this study, the investigators propose to utilize biopsy specimens stratified by drug     response to identify candidate gene expression modules that will be validated in a     prospective study design. The overall goal of this program is to develop a signature of     montelukast response that can be applied not only to eosinophilic gastroenteritis, but more     generally to other diseases, such as asthma, where the drug is widely used with variable     success.   "
70693|NCT02360449|"     The purpose of this study is to investigate whether a social initiation motivation     intervention (SIMI) focused on training children with ASD to initiate to peers during     structured play activities will result in more frequent initiations to typically developing     peers during free play. The SIMI approach under investigation uses behavioral strategies     based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with     ASD to initiate to peers. Children with ASD will be randomly assigned to either the SIMI or a     waiting list. Treatment will be provided for 8 weeks in the context of a weekly social skills     group.   "
70694|NCT02360436|"     Analyis of the Glutathione Cycle in Children with Rett Syndrome   "
70675|NCT02360683|"     This study identify preoperative predictors of response to subthalamic stimulation at 1 year,     3 years and 5 years in terms of quality of life, from a broad prospective multicenter study     French with standardized collection of clinical data , imaging and genetic .      The investigators want to identify factors that predict the improvement of quality of life     for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that     improvement would be less likely to become zero to 3 or 5 years and question the indication     of the subthalamic stimulation (risks and costs). This is part of a process of     personalization of the therapeutic care that is of any interest to the subthalamic     stimulation. It is a therapeutic option that could be dangerous if patient selection is not     optimal , and expensive, if the benefit is not large enough to reduce the number of     medications and hospitalizations medium term . In addition, it will quantify the improvement     of quality of life in the longer term and harmonize national assessments .   "
70698|NCT02360384|"     Irritable bowel syndrome is common. Currently, it is a diagnosis of exclusion. There is     increasing evidence of the importance of the microbiota in the pathophysiology of this     disorder. However, it has been challenging to measure the activity of the microbiota in     vivo as much of the GI tract is inaccessible. Fermentation by the microbiota occurs in the     colon, a by product of which are short chain fatty acids. Measuring pH in the colon could     potentially act as a surrogate marker of fermentation. The investigators are undertaking a     randomised controlled trial in patients with IBS measuring the pH in the digestive tract     using a wireless motility capsule at baseline and in response to dietary changes in patients     with diarrhoea predominant IBS and in response to linaclotide in those with constipation     predominant IBS to ascertain the effect of these interventions on the microbiota and clinical     outcomes.   "
70699|NCT02360371|"     This study will evaluate the magnitude of individual differences that exist in human response     to a blinded study medication.   "
70676|NCT02360670|"     Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled.     Treatment of stroke caused by a blockage in a blood vessel (ischaemic stroke), with     clotbusting drugs improves the chances of good recovery, but must be given within 4.5 hours     of onset. Currently only a small proportion of patients who arrive in hospital within 4.5     hours are treated. This is largely due to uncertainty about diagnosis and concerns about risk     of bleeding associated with clotbusting medication. Patients with mild or improving symptoms     in particular are often not treated because of uncertainty about relative risks and benefits.     However, around one third of these patients go on to be significantly disabled. Routine CT     scanning often does not show abnormalities in acute stroke (which take hours to become easily     visible), and cannot show the extent or severity of blood flow changes in ischemic stroke.      We wish to investigate the value of additional CT scanning that gives information on the     blood vessels (angiography, CTA) and blood flow to the brain (perfusion, CTP) by undertaking     a randomised trial. Extra scans are done in the same scanner and involve some extra     radiation, injections of a contrast dye, and some extra time to acquire process and     interpret. The extra scans may allow better treatment decisions for patients by increasing     diagnostic certainty and by better assessment of stroke severity. However, we do not know     whether the potential gains from better selection justify the resources and potential     treatment delays that are involved. We will investigate whether the proportion of patients     given clotbusting drugs differs between the two scanning protocols; and whether the outcomes     differ, using standard measures of disability. We will also investigate whether use of     different scanner manufacturers' software affect interpretation of scans.   "
70677|NCT02360657|"     The purpose of this study is to determine the safety, tolerability and effect of JNJ-54861911     on level of amyloid-beta in Cerebrospinal Fluid (CSF) and plasma following 4 weeks of     treatment in Japanese participants asymptomatic at risk for Alzheimer Dementia (ARAD) at the     intended target dose range.   "
70678|NCT02360644|"     This study investigates the effect of vitamin D deficiency on drug metabolism and transport     in patients with chronic kidney disease (CKD) and in healthy controls.      The central hypothesis is that vitamin D concentrations independently affect metabolism and     transport function in CKD patients. An over-arching goal of this proposal is to make drug     therapies safer and more effective to reduce the significant morbidity and mortality in     patients with CKD.   "
70679|NCT02360631|"     The purpose of this study is to examine whether or not providing Chantix (varenicline) will     help African American smokers quit smoking.   "
70680|NCT02360618|"     A single arm, single center window of opportunity trial of using a combination of metformin     and simvastatin as a neoadjuvant treatment for patients with invasive bladder cancer who are     to undergo cystectomy. The study will assess the feasibility of conducting window of     opportunity trials in invasive bladder cancer the drug combination's affects on a variety of     important clinicopathologic variables.      The goal is to enroll 44 patients within 18 months. An interim analysis will be conducted at     12 months, and the study will be prematurely closed if fewer than 10 patients have been     enrolled at that time. Patients will be administered 850mg of metformin twice daily along     with 20mg of Simvastatin. Patients will be enrolled following the formal diagnosis of     invasive bladder cancer or at first visit following referral to the London Health Sciences     Center (LHSC). Patient's will receive metformin and simvastatin from the time of enrollment     until the night prior to their operation in the absence of safety or tolerability concerns.   "
70681|NCT02360605|"     In the proposed project the investigators will evaluate two different follow-up approaches to     improve low income patients' completion of initial and annual colorectal cancer (CRC)     screening using the Fecal Immunochemical Test (FIT), the most sensitive FOBT. The purpose of     this study is to compare the effectiveness of two distinct follow-up strategies to promote     CRC screening: a prevention coordinator (PC) approach vs. an automated telephone reminder     (ATR) system. The investigators will adapt a successful intervention tested in the Health     Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy     intervention. Specific Aims: The investigators Primary Aims are to: 1. Compare the     effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening. 2.     Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC     screening. The investigators Secondary Aims are to: 3. Conduct a process evaluation of both     follow-up strategies to investigate implementation and barriers 4. Determine if the effects     of either strategy vary by patients' literacy skills. 5. Explore patient characteristics     associated with CRC screening knowledge, beliefs, self-efficacy, and compliance over time     between study arms.   "
70682|NCT02360592|"     This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to     evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and     hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B     patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3     groups to receive different antiviral treatment.   "
70683|NCT02360579|"     Prospective, 3-cohort interventional study evaluating autologous tumor infiltrating     lymphocyte (TIL) infusion (LN-144) followed by IL-2 after a non-myeloablative chemotherapy     preparative regimen for the treatment of patients with metastatic melanoma.   "
70695|NCT02360423|"     The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8     sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of     patients with de novo coronary artery lesions.   "
70696|NCT02360410|"     The proposed study is a randomized controlled trial that compares the effectiveness of an     electronic personalized health screening app incorporating motivational feedback (i.e.,     Check Yourself) to usual care. The purpose of this study is to determine whether Check     Yourself is more effective than usual care in reducing health risk behaviors and improving     quality of care among adolescents receiving primary health care services.   "
70700|NCT02360358|"     A prospective, multicenter, randomised controlled phase II study in which patients with     therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group)     or with AS210 (control group) to determine the safety and relative efficacy of both products.   "
70701|NCT02360345|"     This is an open label, single-centre dose escalation phase 1 clinical trial of ONX-0801.      The study will evaluate two schedules of ONX-0801 concurrently: once weekly and alternate     week dosing, of repeated 28-day treatment cycles.      The study will consist of two stages: the dose escalation phase, in which the recommended     phase II dose will be determined; and the expansion phase, in which up to 30 patients will be     treated at the recommended phase II dose and schedule to further support the design of     subsequent trials of ONX-0801.   "
72018|NCT02343081|"     The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and     extent of absorption of Temozolomide after the administration of the study product     (Dralitem®, Monte Verde S.A.) and the reference product (Temodal®, Schering Plough) in     primary Central Nervous System patients.   "
70684|NCT02360566|"     Prior research has shown that people with psychotic illnesses, like schizophrenia, who make     sense of and meaningfully integrate their psychotic experiences into their life story are     more likely to recover from their illness. This process of developing a coherent narrative     seems especially relevant for young people who are experiencing their first episode of     psychosis. There is a need for interventions that can help facilitate the formation of     recovery-oriented narratives, particularly in the early stage of illness. Participatory video     is a group process that involves the facilitated creation of short documentary-style videos     in which individuals are supported to reflect on and tell their personal stories. Although it     has been used to foster self-identity, self-empowerment and give voice to a variety of     marginalized and stigmatized populations, its use and evaluation as a clinical intervention     has been limited.      The purpose of this study is to determine whether the novel use of participatory video     facilitate narrative development and promote recovery for individuals with early psychosis is     an effective, feasible, and acceptable means of treating youth in the early stages of     psychotic illnesses. Although the current study is hypothesis generating in nature, the     investigators are expecting that participating in the Participatory Video intervention will     result in improvements in narrative development, symptoms, self-perceived recovery,     self-esteem, self-stigma, social functioning and hope. Additionally, the investigators expect     that Participatory Video intervention will prove to be acceptable to participants and a     feasible intervention for early psychotic disorders.   "
70685|NCT02360553|"     Adolescents nowadays is having most of their times other than school hours spending on screen     by playing games, watching the movies and surfing the internet. Thus, it was suggested that     Internet-based interventions have the potential for establishing healthy dietary style and     physical activity that may persist in adulthood and reduce the risk of chronic disease.     Preventing adolescent obesity requires an attitude of willingness by adolescents to implement     healthy behaviors. By providing the health related activities in website, it would help the     adolescents to spend time on screen by having something which can benefit them and improve     their knowledge and attitudes.   "
70686|NCT02360540|"     PERC rule was created to rule out pulmonary embolism (PE) without further exams, with     residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as     north-American. In European high PE prevalence population, it has been showed that PERC rule     used alone or associated with low clinical probability assessed by revised Geneva score (RGS)     was not safe. In retrospective study, we suggest that the combination of PERC rule with     implicit clinical probability (gestalt) could allow the use of the PERC rule.      PERCEPIC, an observational prospective multicenter study performed in France and Belgium,     will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary     outcome will be the rate of thromboembolic events or death related or possibly related to PE     in patients with low implicit clinical probability and negative PERC rule (8 criteria     absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to     consider PERC rule as safe in this combination.   "
70687|NCT02360527|"     A clear association between type 2 diabetes (T2D) and Alzheimer's disease (AD) has been     reported. This association is independent of vascular impairment, and therefore, it could be     attributed to neurodegeneration triggered or accelerated by diabetes itself. At present there     are no methods to identify T2D patients at risk for developing AD. The retina shares many     features with the brain and, therefore, has been suggested as an easily accessible way of     examining pathology in the brain. In fact, many patients with AD present retinal     abnormalities. However, the diagnosis of diabetes, a condition frequently associated with     retinal neurodegeneration, has not been considered. On this basis, the final aim of this     proposal is to identify diabetic patients at risk for developing AD based on the assessment     of retinal neurodegeneration by means of non-invasive tests. Specific aims: 1) To compare the     prevalence of morphological and functional abnormalities related to retinal neurodegeneration     among three groups of T2D patients: patients with AD, patients with Mild Cognitive Impairment     (MCI) and patients without AD or MCI. 2) To assess whether the retinal neurodegenerative     features are related to severity of AD. 3) To explore whether the combined retinal     neurodegeneration in diabetic patients with AD has a different functional and/or     morphological pattern in comparison with neurodegeneration secondary to diabetes alone.     Methods: Case-control study. Retinal neurodegeneration will be assessed by mutifocal     electroretinogram (mfERG) and spectral domain optical coherence tomography (SD-OCT). The     potential confounders will be considered in data analyses. Feasibility: A unique     multidisciplinary consortium has been created in order to warrant the feasibility of the     project Expected impact: This innovative approach will fill a gap that currently exist in the     health care system and will reduce the economic burden associated with T2D patients with AD.     In addition, this project would be the backbone for future prospective studies.   "
70688|NCT02360514|"     This study was aimed evaluate long-term immunity response by neutralizing antibody test of     adults in high risk population of HFRS .   "
70689|NCT02360501|"     The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB)     nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given     to those patients in order to shrink the tumor volume and facilitate the following radiation     therapy. Thus, in this study, the investigators use the combination of     Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal     carcinoma patients, in order to evaluate the efficacy and safety profiles.   "
70690|NCT02360488|"     The current study will test the effectiveness of a novel home-based telehealth system     designed to improve motor recovery and patient education after stroke. A total of 124     subjects (the number may be larger depending on the rate of subject dropout) with arm motor     deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be     randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic     setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the     subject's home via an internet-connected computer). The intensity, duration, and frequency of     this therapy will be identical across the two groups, with subjects in both treatment arms     receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10     minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor     Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is     the focus here because it is commonly affected by stroke, is of central importance to many     human functions, and is strongly linked to disability and well being after stroke.   "
70691|NCT02360475|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of     different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV     vaccine, in healthy, non-pregnant women aged 18 to 45 years.   "
70692|NCT02360462|"     This is a clinical trial that intend to determine if transcranial direct current stimulation     (tDCS) is effective in the treatment of postoperative pain and in the anxiety level in the     preoperative period of hallux valgus surgical treatment   "
70702|NCT02360332|"     The aim of the research project is to conduct evidence-based research on a nationally known     vocational rehabilitation (VR) service model (Project Search) for individuals with Autism     Spectrum Disorders (ASD). This information may be useful to high schools and vocational     rehabilitation agencies that endeavor to use evidence based practices to serve individuals     with ASD.   "
70703|NCT02360319|"     The goal of this project is to show that the best possible option for preventing relapses in     patients suffering from first episode (<1 year of anti-psychotic medication) or early phase     (< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing     medication adherence. The study is designed to answer the question of whether the use of     long-acting injectable (LAI) antipsychotics early in the course of treatment can break the     cycle of frequent relapse that affects so many patients with early phase schizophrenia. The     participating research sites (not individual patients) will be randomly assigned to either     medication prescribed by their treating physician (with no restrictions) or to a regimen that     involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one     to one basis to either of the arms taking into account types of patient population and     geographical area. Patients enrolled in the study will participate in regular assessments     either over the phone or in person and be followed for a period of 2 years. The primary     outcome measure is time to first hospitalization.   "
70704|NCT02360306|"     Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is widely used     in the diagnosis of mediastinal and hilar adenopathy as well as in staging in lung cancer     patients. Many studies have confirmed the utility of EBUS-TBNA with high sensitivity,     specificity, and accuracy for the diagnosis of mediastinal and hilar adenopathy. 1-3 Less     well reported has been the use of the EBUS bronchoscope to perform other procedures such as     transbronchial biopsy (TBBx), endobronchial biopsy (EBBx), bronchoalveolar lavage (BAL) and     airway brushings. While not well reported in the medical literature, anecdotal evidence     supports these practices. The investigators propose a methodological evaluation of the full     spectrum of procedures that have been performed and that are possible using an EBUS     bronchoscope.   "
70705|NCT02360293|"     This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled     Transforming Prevention into Action aimed at effectively engaging patients and their     families to improve their health and medical care.      This project will test the feasibility and effectiveness of the prevention focused, internet     mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and     demographics of OEF/OIF Veterans.   "
70706|NCT02360280|"     About one-third of depressed patients will not get better after multiple antidepressant     treatments. This situation put a high burden on patients with depression due to worsening     quality of life and increasing health care costs. Difficult-to-treat depression might be even     worse among Veterans given that the frequency of depressive symptoms is 2 to 5 times higher     than among the general US population. A breakthrough discovery happened in recent years when     investigators found that one infusion from an old anesthetic named ketamine showed high     efficacy and rapid antidepressant effect (sometimes within hours) but lasted only up to a     week. The investigators propose to study if multiple infusions of ketamine can provide     greater and longer antidepressant effects than one infusion. If that is the case, multiple     infusions could be an alternative to relieve depressive symptoms that do not response to     multiple antidepressant drugs.   "
70707|NCT02360267|"     The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment     regarding the diagnosis and treatment of pediatric bipolar disorder to children and     adolescents with any current mood state and/or children/adolescents who are offspring of a     parent with bipolar disorder (BD) type I or II and their families.   "
70718|NCT02360124|"     This study is a randomized clinical trial lasting for 30 months. A total of 300 subjects will     be recruited from social centres for elders located in different districts in Hong Kong.     Baseline clinical examination will be conducted by a single calibrated examiner in the social     centres using an intra-oral LED light, mouth mirrors and probes. Subjects will be randomly     allocated into the three study groups and receive interventions accordingly. Follow-up     examinations at 6-month intervals will be carried out to assess the clinical outcomes, i.e.     whether new root caries has developed and whether the active root caries found at baseline     have become arrested (remineralized and hardened) or not. Photographs of the arrested lesions     will be taken to assess their colour. Results of this study will provide the much needed     evidence to guide the dental professionals in Hong Kong and worldwide in deciding on the most     appropriate intervention for the prevention and treatment of this common dental disease of     the older adults.   "
70708|NCT02360254|"     Rationale. Degludec is a longer-acting insulin analog compared to glargine and detemir. In a     fraction of type 1 diabetic patients, insulin glargine and insulin detemir may not achieve     24h coverage, reflected by raising pre-dinner glucose levels when they are administered at     bedtime. As up-titration of bedtime long acting insulin increases risk of nocturnal     hypoglycaemia, this clinical problem can be addressed by an additional injection of in the     morning. These type 1 diabetic patients may benefit from shifting from twice daily insulin     glargine/detemir to once daily insulin degludec, which shows an extended activity over 24h,     up to 48h.      Objective. To evaluate the effects of shifting from twice daily insulin glargine or detemir     to once daily insulin degludec on HbA1c and glucose profiles in type 1 diabetic patients     during a period of 3 months.      Study design. Observational analytic prospective study. Protocol. Type 1 diabetic patients on     twice daily insulin glargine or detemir (because of pre-dinner hyperglycemia due to supposed     glargine/detemir coverage <24h) will be identified and enrolled. During a run-in period of 1     week, the investigators will collect data on HbA1c values as IFCC/DCCT-aligned and on glucose     profiles using glucose meters. Patients will undergo a 7-14 day continuous glucose monitoring     before and eventually during (additional 7-14 days) the shift from twice to once daily basal     insulin. Patients will be re-assessed 12 weeks after initiation of insulin degludec with     determination of HbA1c and 7-14 day continuous glucose monitoring.   "
70709|NCT02360241|"     This study aim is to evaluate the needle positioning precision, compared to the real path     planned by the physician on healthy voluntaries, by positioning a fictional needle, without     inserting it.      Additionally, this study will evaluate:        -  the robot precision,        -  the robot detection robustness,        -  the software and device ergonomics,        -  the device security.   "
70711|NCT02360215|"     This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy     with or without hippocampal avoidance in reducing neurocognitive decline in patients with     cancer that has spread from the primary site (place where it started) to the brain. Whole     brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately,     the majority of patients with brain metastases experience cognitive (such as learning and     memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by     binding to and inhibiting channels of receptors located in the central nervous system.     Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using     radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal     region during WBRT, may reduce the radiation dose to the hippocampus and help limit the     radiation-induced cognitive decline. It is not yet known whether giving memantine     hydrochloride and WBRT with or without hippocampal avoidance works better in reducing     neurocognitive decline in patients with brain metastases.   "
70713|NCT02360189|"     Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR)     attendance and uncover mechanisms of CR non-attendance.      Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level,     comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are     predictors of CR attendance.      Hypothesis b: The expected social gradient in CR attendance is explained partly by     differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and     distance to the rehabilitation clinic.   "
70714|NCT02360176|"     Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the     reference method in terms of complications using a score of morbidity and mortality at 6 and     24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis,     splenic lesions, hernia, residual gastric pouch and mortality   "
70715|NCT02360163|"     The purpose of this study is to reduce, by using the ultrasound guided technique, the minor     surgical procedures that might be required to deliver fluids into the blood of critically ill     patients simply because the patients' veins cannot be located through the manual technique.   "
70716|NCT02360150|"     The purpose of this study is therefore to show that associated with cardiac angiography     echocardiography, in myocardial seen late, would provide the information necessary for the     decision revascularization, in a timely manner.      This would allow the patient to avoid duplication of tests including risk related to coronary     angiography (bleeding complications, stroke ...) and those related to the implantation of     coronary stent (stent) without expected earnings in case of non-viability . This would also     reduce the length of hospital stay and costs due to numerous reviews.   "
70717|NCT02360137|"     Atherosclerosis is the most common cause of stroke. The aims of the project are to compare     the visual and digital analysis of sonographic images of atherosclerotic plaque in carotids     in vivo, in vitro and with a histological composition of the plaque obtained from patients     indicated to carotid endarterectomy, to compare the characteristics of symptomatic and     asymptomatic atherosclerotic plaques and, subsequently to verify a hypothesis that ultrasound     can identify the sonographic plaque characteristics associated with an increased risk of     plaque progression and of ischemic stroke (unstable plaque) in patients with carotid     atherosclerosis. Identifying of the sonographic characteristics of unstable plaque will allow     to improve indication criteria for carotid endarterectomy or stenting and also potential     changing of a drug therapy in patients with unstable plaque in the future. Cost efficiency     and availability of duplex ultrasound equipment may enable to improve diagnosis of unstable     plaque using this new plaque characteristics evaluation in the majority of patients with     carotid plaques.   "
70719|NCT02360111|"     This is a pilot study which will be done in a small number of patients. The purpose of this     study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide -     after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal     kidney function. GVHD is one of the most common complications of a stem cell transplant .   "
70720|NCT02360098|"     Smooth emergence (wake up) from anesthesia is an important consideration in patients     undergoing neurosurgical procedures as blood pressure changes associated with violent     emergence can cause intracranial hemorrhage and brain swelling. At the same time, emergence     should also be quick so that patients' neurological function can be assessed at a timely     manner. Pattern of emergence from anesthesia is poorly investigated and understood. Epilepsy     surgery involves resecting epileptogenic tissues including limbic structures which may be     functionally normal. Hence the emergence process can be complicated in patients having     diseased limbic structures or those having therapeutic removal of limbic structures as in     epilepsy surgery. Limbic structures are responsible for memory, language and executive     function and hence loss of some of these higher functions is to be expected in the     postoperative period. Preoperative neuropsychological assessments are often used to predict     their risk for postoperative loss of higher functions and behavior changes. In our experience     the investigators have seen that there is a spectrum of emergence characteristics in patients     undergoing temporal lobectomy that can vary from dangerously agitated patient to much     sedated, unarousable patient. Delirium and agitation can be dangerous and have serious     consequences for the patient such as injury, increased pain, hemorrhage, self-extubation and     removal of catheters requiring physical or chemical restraint. On the other hand the     unarousable patient may pose dangerous airway complications and limit neurological assessment     in the immediate postoperative period. Hence it is essential to have a clue about post     anesthesia emergence behavior in patients having epilepsy surgeries. The aim of this study is     to look at the pattern of emergence from anesthesia after epilepsy surgery and to determine     if preoperative neuropsychological assessment help predict the pattern of emergence in     patients undergoing anterior temporal lobectomy and amygdalohippocampectomy.   "
70721|NCT02360085|"     Cervical myelopathy is commonly associated with degenerative spinal disease. Dysfunction of     the autonomic nervous system is also evident in many cases of cervical myelopathy. Autonomic     dysfunction may result in haemodynamic instability and hypotension under anaesthesia. It is     important to maintain adequate mean arterial pressure in order to perfuse the spinal cord and     prevent cord ischemia. Heart rate variability, the physiological variations of the     differences between heart beats, has been used to diagnose autonomic dysfunction. In patients     with cervical myelopathy it may enable the anaesthetist to predict hypotension thereby     allowing for early treatment and prevention of spinal cord ischemia.   "
70722|NCT02360072|"     This is a prospective observational study , to clarity the characteristics of airway     inflammation, airway reactivity and airway resistance in rhinitic children with or without     asthma and to explore the possible predictors in the progression of allergic rhinitis to     asthma.   "
70853|NCT02358369|"     The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the     ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma     or ocular hypertension.      This study will evaluate the safety and efficacy of two different doses of the Bimatoprost     Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).   "
70723|NCT02360059|"     The goal of this clinical research study is to learn if metformin can help to control nerve     damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel in     patients with breast cancer.      In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks     like the study drug, but it is not designed to treat any disease or illness. It is designed     to be compared with a study drug to learn if the study drug has any real effect.   "
70724|NCT02360046|"     This study aims at assessing the effect of today's standard of hydrocortisone dosage versus     previous hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots (IMCL     and IHCL) after a standardised fat load followed by a short-term aerobic exercise in patients     with corticotropic pituitary insufficiency.   "
70725|NCT02360033|"     Goals of the study:      Systemic Therapy was approved in 2008 by the Scientific Advisory Board on Psychotherapy     (Wissenschaftlicher Beirat Psychotherapie: WBP) for a variety of disorders which, at the     time, did not include anxiety disorders. According to the 2007 joint methods paper of the WBP     and the Mutual Federal Committee (Gemeinsamen Bundesausschuss: G-Ba), there must be three     randomized-controlled trials (RCT) for anxiety disorders. These studies are available now but     lack explicit details about the clinical significance of the reductions they show in social     anxiety symptoms. This project is funded by the German Association for Systemic Therapy,     Counseling and Family Therapy (Deutsche Gesellschaft für Systemische Therapie, Beratung und     Familientherapie: DGSF).      Study design:      The study is planned as a mono-centric, balanced pilot RCT. It investigates the feasibility     of an RCT comparing Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety     Disorders (SAD) in 32 patients.   "
70726|NCT02360020|"     Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and >90%     of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting     coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses     characterised by better mechanical properties than traditional DES. This is a prospective,     non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS     DES in severely complex coronary lesions in real-world clinical practice.   "
70727|NCT02360007|"     Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence,     current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an     alarming number of clinics have extensive waitlists for treatment slots. Patients can remain     on these waitlists for years, placing them at elevated risk for illicit drug use, criminal     activity, infectious disease, overdose and mortality during this period. These delays in     treatment access represent a significant barrier to the widespread delivery of effective     opioid treatment, and there is a critical need to develop creative new approaches for     mitigating these delays. Our overarching goal in this application is to develop a novel     Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our     integrative treatment package includes five key components, each strategically chosen to     maximize patient access to pharmacotherapy for opioid dependence while minimizing     nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth     clinical support delivered via Interactive Voice Response, Automated random call-backs for     urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The     Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is     to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in     which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to     receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants     who have not entered treatment by Week 12 will be offered the opportunity to cross over to     IBT at that time, contributing additional within-subject data with which to evaluate the     efficacy of the IBT intervention. The proposed research is innovative in several important     ways: By facilitating the eradication of waitlists for opioid treatment, it represents a     significant departure from the status quo and stands to produce a fundamental shift in how     treatment of opioid dependence is conceptualized and delivered. The IBT components are highly     novel, both individually and as an integrative interim treatment package for opioid     dependence. This study will be the first to investigate the utility of IBT in the patients     and settings that stand to benefit most from it. The investigators also propose a     multi-pronged dissemination approach that will ensure that our work is readily transported to     clinical practice and will have a direct impact on real-world treatment of opioid dependence.     Taken together, the proposed project will produce a highly innovative technology-assisted     pharmacotherapy protocol that can be widely disseminated to increase access to life-saving     opioid treatment. The overarching and specific aims of this proposal are directly relevant to     NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse     treatment.   "
70729|NCT02359981|"     MyBehavior is a mobile application with a suggestion engine that learns a user's physical     activity and dietary behavior, and provides finely-tuned personalized suggestions. To our     knowledge, MyBehavior is the first smartphone app to provide personalized health suggestions     automatically, going beyond commonly used one-size-fits-all prescriptive approaches, or     tailored interventions from health-care professionals. MyBehavior uses an online multi-armed     bandit model to automatically generate context-sensitive and personalized activity/food     suggestions by learning the user's actual behavior. The app continually adapts its     suggestions by exploiting the most frequent healthy behaviors, while sometimes exploring     non-frequent behaviors, in order to maximize the user's chance of reaching a health goal     (e.g. weight loss).   "
70753|NCT02359669|"     The objective of the study is to explore the impact of a combined intervention including a     growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive     abilities, mother-child- interaction and behavior in children of 3 to 5 years from less     enriched home environments.   "
70730|NCT02359968|"     Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and     chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy     treatment is the FOLFOX. It is a combination of three drugs administered intravenously:     fluorouracil, oxaliplatin and folinic acid. This is the standard treatment.      Another protocol of chemotherapy is widely used by certain European and American teams, due     to promising results : a combination of two drugs administered intravenously: Paclitaxel and     Carboplatin (CarboP-pacliT). At present, no clinical study has shown the superiority of one     treatment over the other.      The objective of this Phase II study is to clarify clinical practice by comparing these two     chemotherapy treatments.   "
70731|NCT02359955|"     This study aims to evaluate masticatory efficiency of the zero-degree teeth complete denture     in treatment of edentulous patients of severely resorbed ridge.Patients will be crossed over     to be treated with zero-degree teeth complete denture and anatomic teeth complete denture.     For each patient, the masticatory efficiency and electromyography with different denture will     be recorded and analysis.   "
70732|NCT02359942|"     1. To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric          acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest          and H. pylori culture).        2. To compare the delta value of 13CO2 results between before and after ingestion of citric          acid as test meal.   "
70733|NCT02359929|"     Subjects in this study have had an allogeneic (blood or marrow cells from another person)     blood or marrow transplant to treat leukemia, lymphoma or other cancer of the blood, and have     now developed Graft Versus Host Disease (GVHD) that is not responding to standard treatment.     GVHD is when the graft (transplanted bone marrow or blood) attacks the recipient's body. GVHD     occurs early after transplant (acute) and/or sometimes months after transplant (chronic).     Both forms can be life threatening; chronic GVHD can be a lifelong disabling condition.      Mesenchymal stromal cells (MSCs) exist in tissues throughout the body. One place they are     found is in the bone marrow and from here they can be obtained by needle aspiration, the same     way bone marrow samples are obtained to test for leukemia. This study uses autologous MSCs     obtained from the recipient with acute and/or chronic GVHD, which have a lower chance of     being rejected. These MSCs may promote tolerance, helping the donor immune cells accept the     recipient's body.      This trial is being conducted as a step toward testing the long-term hypothesis that freshly     cultured autologous MSC grown in platelet lysate-containing medium will modulate donor T-cell     immune responses and reduce GVHD in allo-HSCT recipients. As a phase I dose escalation trial     of autologous MSC in patients with acute and chronic GVHD, the main aim is to evaluate the     safety of this therapy and its effects on GVHD biomarkers and T-cell phenotype   "
70854|NCT02358356|"     Two parallel phase II randomized open label trials of Lutetium-177 Octreotate     (177Lu‐Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine     (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of     low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone     in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).   "
70734|NCT02359916|"     The pervasiveness of high-calorie, nutrient-poor snacks in the environment is believed to     have contributed to the epidemic levels of obesity and cardiometabolic disease in the U.S.     This project tests whether a novel snack vending machine system that uses brief time delays     to reduce the immediacy of reward from unhealthy snacks will improve the healthfulness of     snack choices. If successful, this project will identify a new environmental intervention     that could contribute substantially to obesity and cardiometabolic disease prevention efforts     in schools, worksites, and other settings.   "
70735|NCT02359903|"     ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic     equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD,     Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing     spondylitis.   "
70737|NCT02359877|"     This is an international multicenter study of tolerability, pharmacokinetics and     pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular     and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec     Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose     administration and multiple estimated therapeutic dose administration of BCD-054.   "
70738|NCT02359864|"     This study is designed to assess the safety and toxicity/adverse events associated with the     use of low dose fractionated whole brain irradiation in those patients who have been     diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria. As a     secondary goal it will establish whether or not the intervention with low dose whole brain     irradiation might change the recognized progression of Alzheimer's Disease. The investigators     will also collect information from the AMYViD ® PET Scans to determine if there is any     correlation between neurocognitive/quality of life scores and changes in amyloid plaque size,     number and location.   "
70739|NCT02359851|"     This phase II trial studies how well pembrolizumab works in treating patients with uveal     melanoma that has spread to other places in the body and usually cannot be cured or     controlled with treatment. Monoclonal antibodies, such as pembrolizumab, may block tumor     growth in different ways by targeting certain cells.   "
70740|NCT02359838|"     This research study is evaluating if co-management by a geriatrician embedded in the oncology     clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry     frailty assessment by a trained research assistant will be followed by randomization to     geriatrician co-management versus usual care for patients found to be frail or pre-frail.   "
70741|NCT02359825|"     Current strategies for peripheral nerve repair are severely limited. Even with current     techniques, it can take months for regenerating axons to reach denervated target tissues when     injuries are proximally located. This inability to rapidly restore the loss of function after     axonal injury continues to produce poor clinical outcomes. The investigators propose testing     the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted axonal     fusion technique to repair peripheral nerve injuries in humans.   "
70754|NCT02359656|"     The purpose of this study was to determine the clinical and radiographic long - term results     in geriatric patients who had undergone surgical or non - operative treatment of odontoid non     - unions, with particular regards to late bony fusion, cervical spine motion, neurological     sequela, and patient's quality of life.   "
77299|NCT02274064|"     This study develops a motivational interview and implementation intention intervention for     blood donor retention and tests the efficacy of this new approach among first-time, Group O     donors.   "
70742|NCT02359812|"     Sensorimotor impairments following stroke can lead to substantial disability involving the     upper extremity. These impairments often involve complex pathological changes across multiple     joints and multiple degrees-of-freedom (MJMD) of the arm and hand, thereby rendering them     difficult to diagnose and to treat. Many potential mechanisms, such as weakness, motoneuronal     hyperexcitability, and elevated passive impedance, can contribute to the impairment, thereby     making it difficult to discern where best to focus treatment. The objectives of this study     are to quantify the progression of neuromechanical properties throughout the upper extremity     during recovery from stroke.      The aim of this study is to examine neuromechanical properties throughout the entire upper     extremity in stroke survivors over a period of 6 months and throughout the progression from     the acute to the subacute to the chronic phases of recovery. The researchers hypothesize that     excessive local and cross-coupled stiffness, heteronymous reflexes, and diminished     individuation and proprioceptive acuity will be present among multiple DOFs in the upper     limb. The stiffness and spasticity will increase with time post-stroke.   "
70743|NCT02359799|"     The purpose of this study is to investigate the effectiveness of home-based and lab-based     stretching and active movement rehabilitation in reducing joint impairments in cerebral palsy     using a portable rehabilitation robot. Children with spastic cerebral palsy and ankle     impairments are divided randomly into two groups, participating in robot-guided passive and     active movement training in a research lab setting (lab group) or in home setting (home     group).   "
70744|NCT02359786|"     This is a retrospective data collection on treatment of various disorders. This registry will     include a variety of different products, implants, technologies and procedures. The registry     will also collect any adverse events/complications that occur during or following treatment     of these conditions. The data may be utilized to develop strategic treatment pathways and/or     benchmarking that will improve patient care. Ultimately, the goal of the registry is to     enhance the understanding of healthcare and the treatment in these disease states.   "
70745|NCT02359773|"     The purpose of this pilot research study is to identify the characteristics of     magnetocardiograms that correlate with a non ischemic chest pain status and a myocardial     infarction patient status. The study uses a non SQUID magnetocardiogram device.   "
70766|NCT02359500|"     This study plans to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide     ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of     response to treatment in patients with Somatostatin receptor expressing tumors who undergo     imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC     as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.     68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs     for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either     at staging or during follow up.   "
70746|NCT02359760|"     INTRODUCTION: Dentoalveolar surgeries such as piezocision, have been developed with the aim     to accelerate the tooth movement and therefore reduce the length of orthodontic treatment.     Although this surgical technique seems to present several advantages, such as decreased risk     of decalcification or orthodontic relapse, its use as a routine practice is not yet     recommended. The main purpose of this study is to determine the duration of orthodontic     treatment by using the piezocision. The secondary objectives are to evaluate the effect of     this surgical technique on bone density, root resorption, osteoclast activity, inflammatory     events and pain assessment. MATERIAL AND METHODS: The investigators will conduct a     prospective pilot study. The experimental group will consist of 20 adults, subjects from 18     to 40 years-old (10 women, 10 men +/- 2). The control group will consist of 40 matched     patients, who have been already treated in the orthodontic clinic of the University of     Montreal. Our research protocol requires a multidisciplinary collaboration. The reliabilities     of Intra and Inter assesors will be measured for each doctor. After completion of the     surgical guides from CBCT, the Piezocision will be performed by a piezoelectric insert     (Piezosurgery) one week after bracket placement. To reduce bias, patients will be randomized     to determine the surgeon and the surgical procedure will be standardized. The appointments     will be every 2 weeks for 4 months, then every month. The investigators will make an     assessment of pain by using a numerical visual scale, during the first 7 days after surgery     and at the orthodontic appointment for the activation of the appliance. Analysis of     inflammatory markers (IL-1) and osteoclast activity (RANKL, OPG) will be evaluated from the     gingival sulcus fluid collected at day 0, day 7, day 21, second month, forth month and sixth     month. At the end of the treatment, the overall quality evaluation of treatment using the     American Board of Orthodontics' grading system would be realized by two blind external     observers to limit bias.   "
70747|NCT02359747|"     try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also     in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole     Genome Amplification before PCR and sequencing of the samples to find the point mutation   "
70748|NCT02359734|"     To identify the key issues around use of computerized patient infusion devices (called smart     pumps).      To develop strategies that will improve the prevention of intravenous errors that will be     broadly applicable.      The investigators will conduct a national study using the general methodology developed by     Husch et al. to allow a rapid assessment of the frequency and types of medication errors at     an institution.      The key questions the investigators will address are:        1. What are the frequency and types of intravenous medication errors?        2. How much variability is there by frequency and type among settings?        3. After review of the initial data, what strategies appear to have the greatest potential          for reducing intravenous medication error frequency?        4. How effective is an intervention including a bundle of these strategies at multiple          sites?   "
70749|NCT02359721|"     The present study was done to evaluate the effect of clarithromycin as an adjunct to scaling     and root planning at baseline, three months and six months intervals . Clinical,     microbiological and immunological parameters were taken. Clinical parameters include gingival     index , probing depth and clinical attachment level. In the present study, improved clinical     and microbiological outcomes were attained using adjunctive clarithromycin, including GI, PD     reduction, CAL gain and reductions in the frequency of detection of C-reactive protein, Pg,     Aa. These results together with the recommended easy dosage and limited side effects make the     use of this antibiotic in the treatment of periodontitis patients but only for a shorter     period of time.   "
70750|NCT02359708|"     This study aims to investigate if recolonisation of the hand flora occur after surgical hand     washing and is there a bacterial leakage at the glove cuff site in cardiac surgery? Also     investigate if thera are differences in microbial flora and recolonisation between hospital     and non-hospital persons.   "
70751|NCT02359695|"     The objective of this study is to assess whether a low dose of GH supplementation (0.5     IU/day) increases clinical pregnancy rates in women with a history of POR who failed to     become pregnant in two previous IVF cycles.   "
70752|NCT02359682|"     This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be     examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam,     The Netherlands). Five video sequences (20 s) was obtained from different sublingual sites,     and digitally stored the images with code numbers that did not reflect volunteers'     information for later offline analysis by automated analysis software (AVA 3.0; Academic     Medical Centre, University of Amsterdam, Amsterdam, The Netherlands).   "
70755|NCT02359643|"     Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology     occurring mostly in infants and children younger than 5 years of age. In developed countries,     it is the leading cause of acquired heart disease in children. However, KD remains a     mysterious disease.      Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard treatment     for KD. Aspirin have been prescribed in treatment of KD for decade even earlier than usage of     IVIG. High dose aspirin mainly act as anti-inflammation, while low dose aspirin as     anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage of KD.     Hsieh et al. reported that KD without high dose aspirin had the same treatment response after     IVIG. Therefore it is still unclear about the necessarily of high dose aspirin in acute stage     of KD.      This study was conduct to investigate the role of high dose aspirin in acute stage of KD via     a multi-center randomized control trail, and we plan to achieve the followings till year     2017:        1. Enroll 300 KD patients from multiple medical centers . Randomize group patients as group          1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low          dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute          febrile stage, only use low dose aspirin (N=150).        2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT,          BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate          (followed at least 1 year).   "
70756|NCT02359630|"     Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during     general anesthesia.   "
70757|NCT02359617|"     The study seeks to evaluate a novel treatment approach for performing continuous real-time     glucose sensing and insulin delivery at the same subcutaneous tissue site.   "
70767|NCT02359487|"     The overall purpose of this study is to evaluate an intervention that aims to reduce     alcohol-related HIV sexual risk behaviors among HIV-negative men in Namibia. The objectives     of the study are to determine the effectiveness of an individual counseling intervention in     reducing alcohol-related HIV sexual risk behaviors among men, and in reducing harmful and     hazardous alcohol use among men.   "
70768|NCT02359474|"     This trial compares trabectedin alone to trabectedin in combination with regional     hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to     demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.   "
70758|NCT02359604|"     Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it     has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the     pH may lead to changes in the intestinal microbiome. Small series published in adults suggest     a predominance of streptococci, a possible reason for increased incidences of pneumonia under     PPI therapy. Studies in children are yet scarce.      This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance     monitoring. All patients will have undergone conservative measures prior to initiation of PPI     therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks     (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under     PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal     microbiome will be determined by 16S rDNA-based microbial community profiling by     high-throughput pyrosequencing.      Data will be compared by dependent non parametric test (Wilcoxon). P-values <0.05 will be     considered statistically significant.   "
70759|NCT02359591|"     【Background& Purpose】In order to early detect the problems a child might have during his/her     development, an effective screening tool is of great needs. The [Taipei City Child     Development Screening checklist] is often used to serve this process. This text version is     mainly distributed to the parents to fill out during their child regular check-ups to the     hospitals and clinics. The drawbacks of this checklist is that it lacks of active     participation of the target population, and the text version limits its usage to people who     are not familiar with Chinese characteristics, such as those new inhabitant. These lead to     low screening rates therefore causing delayed early intervention. 【Purpose】The purpose of     this study was to design and develop the multi-media graphic version of the [Taipei City     Child Development Screening checklist] based on its original text version.【Method】The     developed muti-media system will be checked for is validity. Thirty parents/legal guardians     of children in each target age groups will be recruited randomly for the clinical reliability     evaluation.   "
70760|NCT02359578|"     The lymphatic system is one of the keystones of fluid homeostasis in the interstitium. In     analogy with the arterial systolic pressure, the lymphatic systolic pressure can give us     information about the functioning of the cardiovascular system and fluid exchange. Actually,     knowledge about this physiological parameter is incomplete because of the lack of technology.     Former measurement techniques of the lymphatic systolic pressure in the living healthy man     were invasive and too complex to be interpreted.      The lymphatic occlusion pressure has to be clarified because lymphedema treatment, concerning     the pressure to be applied on the edematous tissue is still based on controversial concepts.      On one hand, techniques such as Manual Lymphatic Drainage, sustain the necessity to apply a     very low pressure in order to avoid the squeezing of superficial lymph vessels. On the other     hand sustainers of Intermittent Compression Therapy advocate the necessity to apply     relatively high pressure to obtain a decongesting effect. These completely opposite opinions     triggered us to study lymphatic pressure more thoroughly.      Lymphofluoroscopy (emerging imaging technique in the field of lymphology) is now used since 3     years by the promoters of this study to visualize the architecture of the superficial     lymphatic network and the progression of the lymph inside the highlighted vessels. This     technique will be used in the present (prospective and multicentric) study to observe the     effect of a pressure applied on the limb on the displacement of the lymph, and then to     determine the occlusion pressure of the lymphatic vessels.   "
70761|NCT02359565|"     This phase I trial studies the side effects and best dose of pembrolizumab and to see how     well it works in treating younger patients with high-grade gliomas (brain tumors that are     generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas     (brain stem tumors), or brain tumors with a high number of genetic mutations that have come     back, progressed, or have not responded to previous treatment. Monoclonal antibodies, such as     pembrolizumab, may block tumor growth in different ways by targeting certain cells.   "
70762|NCT02359552|"     This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of     concept three-site study, to evaluate the effect of Rasagiline in the regional brain     metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).   "
70763|NCT02359539|"     The use of autogenous graft materials has been recorded to be a gold standard in regenerative     therapy. This study directed toward evaluation of two autogenous regenerative materials,     marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers     for treating intrabony defects. In spite of its reported significant clinical outcomes, the     limited availability of the periosteum makes it necessary to evaluate other autogenous     alternatives such as PRF that could offer predictable outcomes.   "
70765|NCT02359513|"     Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises     followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an     increasing prevalence and a serious prognosis, due to excess mortality by suicide but also     somatic complications.      Two types of treatments are validated : serotoninergic antidepressants (SSRI) and     psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies     also emphasize the important proportion of non-responders to SSRI, few of them analyze the     reasons for this non-answer.      To better understand the mode of action of SSRI, we should analyse the serotonergic activity     in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor     ligands ([18F] MPPF or [11 C] WAY-100635), were used in positron emission tomography (PET) to     characterize the serotonergic abnormalities of bulimic patients. The ligand [18F] MPPF has     the feature to be sensitive to the level of endogenous serotonin.      A first pilot study using PET with [18F] MPPF realized between the University Hospital of     Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of [18F]     MPPF in bulimic patients, suggesting a decrease in serotonin activity.      The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate     gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse,     taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity     of cortical binding of [18F] MPPF.      In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic     activity, it seems necessary to continues investigations, to determine if there is a link     between brain serotonin profile and responding to SSRI in bulimia nervosa.   "
70808|NCT02358954|"     The goal is to establish the practical usefulness of vestibular stimulation for modulating     pain perception and to describe the possible mechanisms that could underlie neural     vestibular-somatosensory interactions.   "
70769|NCT02359461|"     The purpose of the study is to demonstrate an improvement of vascular function, and     particularly dependent vasodilation flow and micro-vasculature, by STENDO for diabetic     patients compared to a control period in crossover.      Action by shear stress causing vasodilation away from the microcirculation, STENDO should     have a beneficial effect on vascular function in type 2 diabetics. These effects could be     both treble just after the completion of a session with the device, and chronic with a     potentiating effect of different sessions.      The investigators propose to study the different vascular function evaluation parameters we     have, to highlight these acute and chronic changes. The investigators will also study the     physical abilities to change topics and behavioral changes (spontaneous physical activity in     particular) and impact on subject quality of life.   "
70770|NCT02359448|"     This is an an open label clinical trial of sustained-release Melatonin 2mg once daily for 12     weeks in patients with Parkinsons's Disease reporting nocturia, defined as getting up     regularly at night > twice to pass urine. The primary objective of this study is to evaluate     the effects of exogenous melatonin on bother related to nocturia. Secondary objectives are to     evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night     3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality of     life 5) Sleep disturbance of partners 6)Safety   "
70771|NCT02359435|"     Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection     with less cost than standard triple therapy. Whether reverse hybrid therapy can replace     standard triple therapy as the recommended first-line treatment is unknown. The investigators     compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in     first-line treatment.   "
70772|NCT02359422|"     The purpose of this study is to conduct a randomized controlled trial of a media literacy     education program for middle school students with the goal of enhancing decision-making     skills to prevent early and risky sexual behavior and teen pregnancy, and encourage healthy     relationships.   "
70773|NCT02359409|"     This study aims to look if use of goggle balloon can help to complete colonoscopy in patients     with very redundant colons.   "
70774|NCT02359396|"     This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to     investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and     pharmacokinetics profile.   "
70775|NCT02359383|"     Chest physiotherapy (CP) facilitates the absorption of fluid in the pleural cavity and     reduces the formation of fibrous adhesions in patients with pleural infection, allowing a     faster clinical, functional and radiological improve. The aim of the study is to determine if     the CP associated with conventional medical treatment (CT) improves functional sequelae     secondary to pleural infectious.   "
70776|NCT02359370|"     Justification and Objectives: The hemodynamic response to stimuli of the airways is a common     phenomenon and its control is important to decrease systemic repercussions. The objective of     this study is to compare the effects of intravenous administration of Magnesium Sulphate     versus Lidocaine in the hemodynamics of this reflex after laryngoscopy and tracheal     intubation. Methods: This double blind, randomized, single center, and prospective study     evaluated 56 patients, ASA 1 or 2, aged between 18 and 65 years, scheduled for elective     surgeries under general anesthesia with tracheal intubation. Patients were divided into two     groups. Group M received 30mg/kg of Magnesium Sulphate, and group L 2 mg/kg of Lidocaine     through continuous infusion, immediately before induction of anesthesia. The values for blood     pressure (BP), heart rate (HR) and bispectral index (BIS) were measured in both groups at six     distinct moments related to the administration of the drugs under study.   "
70778|NCT02359344|"     A randomized, double-blind, placebo controlled, two period crossover study to investigate the     pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in     healthy young versus elderly male and female subjects. Treatment periods will be separated by     13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.   "
70779|NCT02359331|"     As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter     pylori (H. pylori) therapies has been declined coincidentally.      In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7     days personalized therapy for H. pylori infection based on the results of antibiotics     resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14     days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the     prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored     therapy group.   "
70780|NCT02359318|"     Background: Orthodontic bracket debonding is known to cause side-effects such as enamel     cracks or fractures. There is a lack of information on potential benefits or side-effects of     removing brackets from infiltrated enamel, in terms of enamel damages, in vivo.      Purpose: To assess enamel damages following debonding in demineralised teeth with or without     prior infiltration (Icon, DMG, Hamburg, Germany), compared to those following bracket removal     from sound enamel, in order to provide guidelines for the right time point of infiltration of     post-orthodontic lesions (during or following orthodontic treatment).      Design: Single-center, randomized, single blinded, split-mouth controlled clinical trial     Subjects: 30 subjects with fixed multi-bracket (MB) appliances treated at the orthodontic     clinic of Dr. Roberto Vogel, Temuco, Chile: It is planned to include 20 consecutive patients     with extensive decalcifications, and 10 patients without decalcifications. Random allocation     of demineralized dental arch quadrants to the different treatment groups (debond with or     without prior infiltration, and sound teeth).      Investigated tooth groups: Upper and lower canines, and upper and lower incisors.      Methods: Bracket bonding procedure (Transbond XT 3M, Unitek) is identical for all patients     and also for the re-attachement of brackets. Teeth allocated to the infiltration group will     receive bracket removal, infiltration and rebonding of new brackets 4 weeks prior to final     debonding. De-bonding procedures are identical for all patients.      Silicone replicas are made directly following bracket removal (prior to adhesive removal).     Replica analysis is performed using a confocal microscope (Zeiss LSM780) at the Department of     Cell Biology, University of Concepción, Chile.   "
70837|NCT02358577|"     To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the     efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual     care physiotherapy, on functional recovery in critically ill children.   "
70781|NCT02359305|"     This is a retrospective chart review. The objective of the current study is to determine the     analgesic efficacy and side effect profile of intravenous acetaminophen when administered to     infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were     administered intravenous acetaminophen will be compared to infants who did not receive     intravenous acetaminophen to determine if there were any appreciable differences with regard     to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.   "
70782|NCT02359292|"     The study is performed to evaluate the total systemic exposure and lung bioavailability of     CHF 5993 pMDI combination, in healthy volunteers subjects.   "
70783|NCT02359279|"     The proposed test is intended to enable dentists to differentiate between cavitated and     non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).     In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays     (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low     sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,     pain, root canals, and possible later loss of teeth.   "
70784|NCT02359266|"     This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive     symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with     normal vitamin D levels will be monitored as controls, and they will not receive any     intervention.   "
70785|NCT02359253|"     The purpose of this study is to address the allocation of therapy resources between the arm     and the hand as well as to examine the benefits of combining passive stretching with active     movement training.   "
70786|NCT02359240|"     The current project was designed to examine dynamic changes in muscle wasting during sepsis.     Researchers will focus the mitochondrial dysfunction of muscle cells and investigate the role     of HO-1 in it. Researchers interested in identifying factors involved in the pathology of     muscle wasting during sepsis.   "
70787|NCT02359227|"     Planned enrollment is approximately twelve subjects with stable chronic heart failure.     Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose     increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug     Delivery System. Planned infusion rates of cenderitide will be administered to subjects     continuously during four, 48-hour infusion periods.   "
70788|NCT02359214|"     Supplementation studies with vitamin D have been performed where cardiometabolic risk markers     have been assessed but these are few, and results are inconsistent. Hence, the purpose of     this study is to determine:        1. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in          overweight and obese adult participants for 8 weeks will significantly increase          circulating concentrations of 25(OH)D or achieve optimal vitamin D status.        2. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in          overweight and obese participants for 8 weeks will significantly improve the          cardiometabolic parameters measured.        3. To evaluate the relationship between these variables and 25(OH)D concentration. We          hypothesise that there will be a significant increase in plasma 25(OH)D following 8          weeks (56days) supplementation of oral vitamin D3 at a dose of 5000IU/day (125µg);          Administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and          obese participants for 8 weeks will significantly improve the cardio metabolic          parameters measured, and there will be a relationship between these variables and          25(OH)D concentrations.   "
70789|NCT02359201|"     The purpose of this study is to evaluate the reduction of craving after administration of     V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.   "
70790|NCT02359188|"     Randomized, double-blind trial to investigate the influence of a single 4 hours episode of     transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines,     chemokines, neuropeptides, cerebral resting state and gastric motility in healthy volunteers.   "
70791|NCT02359175|"     Whereas it, in the case of conventional thoracotomy, has been demonstrated that thoracic     epidural analgesia is more effective than systemic opioids in terms of pain relief and     preservation of postoperative pulmonary function, the efficacy of epidural analgesia in     video-assisted thoracic surgical (VATS) procedures, has not been sufficiently studied, but a     beneficial effect might very well be present.      On the other hand, the risks associated with placement of a thoracic epidural catheter are     well known and if similar pain relief can be achieved without it with no or only     insignificant alternative side effects, this would be preferable.      The literature regarding the usefulness of epidural analgesia for reducing pain in     Video-Assisted Thoracic Surgery is, at best, scarce with two small studies showing some     effect and two showing no difference, none of the studies being blinded randomized controlled     trials of adequate size.      The SEAVATS Study will try to answer this question.   "
70792|NCT02359162|"     Purpose :To compare the efficacy and and safety of the P-Gemox chemotherapy regimen with     those of the EPOCH regimen for stage IE to IIE ENKTL.   "
70793|NCT02359149|"     Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last     years indications for their use and consequently the number of patients needing treatment,     have been increasing. Most patients require multiple injections. This has resulted in many     eye departments administering thousands of injections per year, also at St Olavs University     Hospital Trondheim. To cope with this increase in workload, it would be helpful if injections     would be given not only by the physicians but also by the nurses. This study's objective is     to compare efficiency, patient satisfaction and cost per patient of injections given by     nurses and physicians.   "
70794|NCT02359136|"     Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce     opioid requirements and improve the patient's mobilization after total hip arthroplasty     (THA). However, the evidence for LIA in THA remains to be clarified.      Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen     reduces acute postoperative pain and opioid requirements after THA.   "
70852|NCT02358382|"     The purpose of the study is to determine whether it is possible to manage the flow of blood     through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what     effect this has on how well the major organs of the body work.   "
72019|NCT02342028|"     To compare the number and function of regular T cell of patients with obstructive sleep apnea     (OSA) versus that of age-, gender- and BMI (body mass index)-matched controls   "
70795|NCT02359123|"     The main purpose in the treatment of patients with advanced cancer and cancer anorexia     cachexia syndrome (CACS) is to prolong life and to improve quality of life (QoL) as far as     possible. QoL in patients with CACS is directly related to loss of appetite and loss of     weight. Cannabis pills are given in Israel to advanced cancer patients with various symptoms     in order to improve their QoL. There is data on safety/toxicity of cannabis, and these pills     are given under the regulations of the Israel Ministry of Health.      The purpose of this study is to examine the influence of Cannabics capsules on improving loss     of appetite and loss of weight.   "
70796|NCT02359110|"     The purpose of this study is to prospectively determine the influence of immediate     pre-operative gabapentin administration on acute postoperative pain. The investigators     hypothesize that immediate post-operative pain will be improved with pre-operative     administration of gabapentin.   "
70797|NCT02359097|"     This clinical trial studies steady state blood volume maps using ferumoxytol     non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma.     MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used     to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol     non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor     cells and the blood vessels in and around the tumors.   "
70798|NCT02359084|"     Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed     by age two, and that early identification and intervention can improve outcomes. Low-income     and minority children with ASD, however, are diagnosed later and experience greater delays in     service provision than their white and more financially advantaged peers. Feasible,     culturally appropriate interventions with broad scale-up potential are necessary to reduce     this disparity. This project builds upon pilot studies of an adapted version of Patient     Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient     Navigation is a lay-delivered case management approach that focuses on overcoming logistical     hurdles to care during a defined episode.      This project has 2 components, both of which take place in urban, integrated care networks     that provide healthcare to low-income children. This registration is for the clinical trial     component of the study. The project is a multisite, randomized comparative effectiveness     trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family     Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD     diagnosis is made. The basic structure of both intervention arms is a collaborative care     system. The conventional care management arm (CCM) is consistent with the type of care     provided within a traditional - but high quality - medical home. The FN arm provides more     intensive, individually tailored, care coordination and theory-based family support.   "
70799|NCT02359071|"     The primary aim of our study was to analyze the independent factors affecting handover     duration in Emergency Department. The secondary aim was to identify the factors affecting     Emergency Department handover rates.   "
70800|NCT02359058|"     The main purpose of this study is to evaluate the safety and tolerability of ramucirumab in     Japanese participants with advanced stomach cancer who have not received chemotherapy.     Participants will take ramucirumab in combination with other anti-cancer drugs.   "
70801|NCT02359045|"     This study is a randomized, open-label, cross-over study in healthy subjects performed at a     single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of     the study is to compare the pharmacokinetics (PK) of three different prototype capsule     formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg     under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be     used as basis for choice of formulation for further pharmaceutical development.   "
70802|NCT02359032|"     The purpose of this study is evaluate the safety and tolerability of single and multiple     ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of     ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study     will also evaluate the pharmacodynamics of ASP6858.   "
70803|NCT02359019|"     This phase II trial studies how well pembrolizumab works in treating patients with extensive     stage small cell lung cancer after completion of combination chemotherapy. Pembrolizumab may     be effective in controlling small cell lung cancer for a longer period of time in patients     with responsive or stable disease after completion of combination chemotherapy.   "
70804|NCT02359006|"     Opioids are the most commonly utilized pharmacological treatment for moderate to severe pain.     However, their clinical value is hindered by the development of opioid-induced hyperalgesia     (OIH). OIH manifests as heightened pain sensitivity, and is an increasingly challenging     drawback to the efficacy of opioid treatment. Although the mechanism of action modulating OIH     is not completely understood, previous animal studies suggest that this phenomenon is a     result of proinflammatory responses. Thus, administering an adjunct anti-inflammatory agent     may attenuate OIH. Minocycline is one such agent; it is a tetracycline derivative antibiotic     that inhibits microglia activation, nitric oxide (NO) production, and the release of     pro-inflammatory cytokines and chemokines. In fact, recent evidence suggests that minocycline     may attenuate the neuroinflammatory effects of opioids while enhancing their antinociceptive     effects. Therefore, the investigators will determine if minocycline will mitigate OIH in     methadone-maintained patients.   "
70805|NCT02358993|"     The investigators will determine the efficacy of an innovative short regimen of methenamine     hippurate on prevention of post-operative UTI in patients requiring short-term     catheterization after pelvic reconstructive surgery through a single-blind, randomized     controlled trial. Primary outcome will be the rate of symptomatic UTI within 3 weeks of     catheter removal. The investigators will study cost-effectiveness, antibiotic resistance     profiles, and adverse drug effects. Findings may reduce antibiotic use and nosocomial UTIs.   "
70806|NCT02358980|"     Hypothesis: Free light chain (FLC) removal haemodialysis will increase the rate of renal     recovery in patients with cast nephropathy, severe renal failure and de novo multiple     myeloma.      This study will evaluate patients with multiple myeloma and severe renal failure treated with     KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.   "
70807|NCT02358967|"     Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease,     attributed in part to increased oxidative stress, inflammation and dyslipidemia. Intervention     with a naturally occurring dietary supplement may improve certain biomarkers of inflammation     and oxidative stress and improve the lipid profile.   "
70809|NCT02358941|"     Attention deficit/hyperactivity disorder (ADHD) is among the most common childhood-onset     psychiatric disorders, with a negative and long-lasting impact on academic achievement,     social integration and quality of life. In recent years, the efficacy of non-pharmacological     treatments for ADHD, such as neurofeedback training (NF) and computerized cognitive training     (CCT), has been at the centre of research. Although an increasing number of well-designed     studies have shown that both methods may improve ADHD core symptoms according to parents'     ratings, the underlying mechanisms are still a matter of debate. Teachers often report     smaller improvements, if any. This has been explained by their lesser involvement in the     training. It remains questionable, however, whether other factors may also account for this     effect and whether methods other than placebo control may be applied in order to demonstrate     the specificity and efficacy of NF and CCT.      The main purpose of this project is to demonstrate and compare the efficacy of two different     computer-based treatment methods for children and adolescents with ADHD, namely NF and CCT,     and to examine the impact of different treatment settings, with half of the participants     being trained in a clinical setting and the other half at school. The investigators want to     show that is feasible to implement NF and CCT in a school setting and that both methods,     conducted either at school or in a clinical setting, may lead to significant improvements of     ADHD symptoms as well as to specific and differential effects. Besides the differential     impact of the settings on informant ratings, the investigators will evaluate the effects of     the training methods on neuropsychological and electrophysiological outcome. Classroom     behavior of the children before and after the training will be evaluated by trained observers     not informed on treatment assignments and settings.   "
70810|NCT02358928|"     Concurrent with the rising prevalence of childhood obesity, the co-morbid condition of     non-alcoholic fatty liver disease (NAFLD) has become the leading cause of chronic liver     disease among children. NAFLD is characterized by accrual of excess triglycerides (TG) in the     liver that leads to inflammation, fibrosis, and cirrhosis. One-third of the pediatric     population has NAFLD, a disease strongly associated with insulin-resistance and     metabolic-syndrome (Met-S). NAFLD is predicted to become the leading cause of liver     transplantation in adults by 2030.      Current understanding of NAFLD indicates that presence of excess TG in liver is an absolute     requirement for disease progression. First-line therapy for NAFLD is focused on decreasing     adiposity and improving insulin sensitivity through diet and exercise. Recent adult data     indicate that dietary carbohydrate-restriction is more effective at reducing hepatic     TG-content than traditional calorie-restriction. Few studies have been conducted to establish     resolution of hepatic steatosis by any intervention. Such studies in pediatrics are primarily     limited by a need for liver biopsy. However, hepatic proton magnetic resonance spectroscopy     (H-MRS) is a new innovative tool used to quantitatively measure hepatic TG content in a     non-invasive manner.      The primary aim is to compare the impact of dietary weight loss via carbohydrate-restriction     and calorie-restriction on hepatic TG-content quantified by H-MRS in obese children with     biopsy-proven NAFLD and Met-S.      This IRB approved protocol is a randomized control study. The investigators will recruit     subjects from the Center for Obesity and its Consequences in Health and the pediatric     gastroenterology clinics between the ages of 11-17 years who meet criteria for NAFLD and     Met-S. A H-MRS will be obtained in each subject prior to the start of dietary intervention.     Fifty-four subjects will be randomized to either a carbohydrate-restricted or     calorie-restricted diet for 6 months with no change in baseline activity. A repeat H-MRS will     be compared to baseline to determine the whether dietary carbohydrate-restriction is superior     to calorie-restriction for reducing hepatic TG content. The investigators believe that     subjects on the carbohydrate-restricted diet will have marked decrease in hepatic TG content     compared to those in the calorie-restricted diet given the same degree of reduction in body     mass index.   "
70811|NCT02358915|"     The current study intends to test the effectiveness of a two-step training paradigm for a set     of skeletal muscles, which are above and behind the external portion of the ear     (Peri-auricular muscles).   "
70812|NCT02358902|"     This study consists of a randomized, double-blind, clinical trial with two months' duration     of follow-up. The variable used was the VAS for pain, considering the values of any     difference between the data before and after stimulation.   "
70813|NCT02358889|"     The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic     effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in     combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating     patients with choroidal neovascularization (CNV) secondary to age-related macular     degeneration (AMD).   "
70814|NCT02358876|"     Study objectives are to improve motion sensor algorithms for measuring bradykinesia in the     clinic and the home, evaluate test-retest reliability of motion sensor algorithms for     measuring bradykinesia compared to clinician raters, determine if participant-perceived     symptom severities correlate with motion sensor measures, determine if speed, amplitude, and     rhythm fluctuate differentially throughout the day in individuals with implanted deep brain     stimulation systems, receive feedback on the usability of Kinesia One, and evaluate Kinesia     One compliance in the home.   "
71010|NCT02356289|"     The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and     pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind,     placebo-controlled, sequential group, single ascending (oral) dose study in healthy     volunteers aged 18-55 years.   "
70816|NCT02358850|"     This is a randomized prospective study to determine the optimal postoperative pain medication     regimen for adults (18 years old and older) undergoing tonsillectomy with or without     adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea. All     participants will undergo the same tonsillectomy surgical technique (with or without     adenoidectomy) under general anesthesia and be randomized to one of three postoperative pain     control regimens (all of which are commonly used pain medications for post-tonsillectomy     pain):        1. Norco (Hydrocodone and Acetaminophen)        2. Percocet (Oxycodone and Acetaminophen)        3. Dilaudid and Tylenol (Acetaminophen)      Participants will be discharged home the day of surgery and will be sent home with     questionnaires to assess their daily pain level, oral intake, amount of nausea/vomiting, and     amount of pain medications taken for the 14 days following their surgery. Data will be     collected and analyzed to determine if there is a difference in pain levels or oral intake or     nausea/vomiting in the different pain regimen groups. Secondary endpoints will include weight     change from preoperative weight to weight at 2-3 weeks after surgery in addition to     postoperative complications including visits to the Emergency Department and     post-tonsillectomy bleed rates.      Participants will be seen 1-2 weeks following their surgery in the ENT (Ear, Nose and Throat)     clinic per normal postoperative protocol and will not require any specific clinic visits     related to this study.   "
70817|NCT02358837|"     With the proposed project we seek to advance the detection and diagnosis of breast cancer in     an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim     of this study will be to explore whether there is an advantage of ductosonography over     conventional breast sonography in detecting and localizing breast lesions by comparing the     diagnostic accuracy of ductosonography and conventional breast sonography in detecting     suspicious and unclear sonographic lesions.In Addition, reliability and time requirement of     ductosonographic examination will be investigated. The second specific aim is to investigate     the potential of tissue elasticity as a diagnostic marker in solid breast lesions (US-BI-RADS     3, 4 and 5) by elastosonography. The study design allows investigating the reproducibility of     the method.   "
70818|NCT02358824|"     A randomized, open-label, single-dose, four-period, two-way, crossover study,   "
70819|NCT02358811|"     Sleep apnea is a common disease in the general population and more particularly in elderly     subjects in whom prevalence can reach 30 % after 70 years old. In adults (<55 years old)     cardiovascular consequences are well known and make sleep apnea treatment necessary. However     elderly (>70 years old) apneic subjects are less symptomatic in terms of sleepiness, they     usually present a lower index of respiratory events and cardiovascular consequences in this     population are still discussed, driving some authors to consider sleep apnea in the elderly     as a specific disease and making the need for a treatment questionable.      In this study the investigators will focus on the comparison between adult and elderly apneic     subjects in terms of cognitive and cardiovascular consequences. Adult apneic patients suffer     from a decrease of cognitive performance as well as grey matter local atrophy, particularly     in the hippocampus and in the frontal lobes. According to fewer studies, white matter can     also be affected by a demyelinisation process. These structural modifications are sometimes     associated with disorders of executive and memory functions. In the elderly, no clear     association can be drawn between cognitive decline and sleep apnea. Moreover, to our     knowledge, the cerebral state of elderly symptomatic apneic subjects has mostly not be     investigated.   "
70820|NCT02358798|"     The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat     children from birth. New treatments used for young children involve to assess efficacy     criteria specific to this population. Standard respiratory function criteria for older     children and adults is forced expiratory volume/second.      This technique is not suited for preschool aged children (3 to 6 years old) because they are     too old to be sedated and too young and immature to be able to make forced expiration     technique that are correct, reproducible and prolonged during more than 1 second.      For preschool aged children, in order to assess distal damage and her consequence, the     evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic     measure of specific resistance (sRaw), functional residual capacity by Helium dilution     technique (CRF He), arterial blood gas measurement, pulmonary clearance index.      All these methods have a better success rate and can be used in alternative or with forced     spirometry. However, each of them gives only a part of information on airway and lung damage     of detected children. It is necessary to combine them for a better information on overall     respiratory damage.      In France, each respiratory function test laboratory uses one or any of these methods in     addition to flow-volume curve, in function of his practices and his equipment.      So, respiratory function test of preschool aged children is going to diversify more and more     to the detriment of an homogeneity of practices between different centers.      A referent population during a longitudinal multicenter monitoring on large cohorts that     describe the evolution of pulmonary function, obtained by a standardized methodology is     necessary to assess the efficacy of any new treatment. And, with the homogenization of care     of children detected of cystic fibrosis in different centers, the description of natural     evolution of pulmonary function by a standardized methodology will improve the discriminative     power of measure of respiratory function to assess the presence of a worsening in     preschool-aged children.   "
70821|NCT02358785|"     This study will provide clinical data in an observational setting. Individuals undergoing     LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed     according to institutional standard-of-care (SOC) using the study stapler. All study subjects     will be followed for approximately 4 weeks for safety and outcomes.   "
70822|NCT02358772|"     This is a comparison of clinical outcomes between a pre-hospital and an in-hospital     thrombolysis patient registry.   "
70823|NCT02358759|"     In this newly developed protocol, and idea, is to manage those abnormally developed zygotes     from different ART procedures.      The investigators developed the plan and requirements needed to select the target extra     nucleus or pronuclei to be extruded from fertilized egg in order to maintain developing     healthy normal embryo.   "
70860|NCT02358278|"     The goal of this study is to determine the incidence and characteristics of Emergence     Delirium (ED) in children aged 0 - 13 undergoing general anesthesia and being taken care of     at the paediatric PACU of the Charité Campus Virchow-Clinic. Therefore the Paediatric     Anesthesia Emergence Delirium Scale (PAED) is used. In order to measure the patient's pain     level, age-appropriate pain scales (CHIPPS or FPS-R) are applied. Risk factors for the     occurrence of ED are to be determined and therapeutic approaches in case of an occurring ED     are to be evaluated. Finally the future implementation of ED-monitoring in the PACU is to be     prepared.   "
70824|NCT02358746|"     Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is     performed primarily by early referral; while at the same time we still struggle with the     limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs     from ischemic substrate have an epicardial exit. However, one cannot accurately predict who     is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate     homogenization in a first approach to be superior to endocardial substrate homogenization     alone, in terms of recurrence on follow-up.      Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise     approach in the ablation of ventricular tachycardia in a population with ischemic     cardiomyopathy on VT recurrence.      Study design: Multicenter prospective open randomized controlled trial. Study population: All     patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular     tachycardia ablation.      Intervention: One group undergoes endo/epicardial ablation and the other group has     endocardial ablation only as a first approach.      Main study parameters/endpoints: The main study endpoint is the difference in recurrences of     ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator     (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure     success and safety.   "
70825|NCT02358733|"     This is a pilot study which aims to determine the role of IMSI in poor responders.   "
70826|NCT02358720|"     This study is a prospective, randomized, monocentre, controlled explorative study in the     parallel-group design to determine the pain relief after RT of patients with spinal bone     metastases. Thereby two different techniques were evaluated: single fraction IMRT with 1 x 24     Gy versus fractionated RT with 10 x 3 Gy. Prior to their enrolment into the study, the     patients will undergo a staging of the vertebral column in connection with their     radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After     the baseline results have been recorded, the patients will be randomized into one of the two     groups: single-fraction IMRT 1 x 24 Gy (n = 30) or fractionated RT 10 x 3 Gy (n = 30). The     target parameters will be measured and recorded at baseline, at the end of RT (t1) and twelve     weeks (t2) and six months following the end of the irradiation period (t3).   "
70827|NCT02358707|"     The specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen     phonophoresis will be analyzed.   "
70828|NCT02358694|"     This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate     (SBI) is safe and well tolerated in pediatric patients with IBS-D.      Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant     adverse events at 4 and 8 weeks and their quality of life will be better than the patients     who receive placebo.   "
70829|NCT02358681|"     Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in     the pediatric population; however, it is typically administered by the intravenous (IV) or     intramuscular (IM) routes, both of which require a painful and distressing needle stick to     administer.      The intranasal (IN) route is a painless and effective way of administering analgesics,     including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for     painful conditions, including acute migraine headaches. However, IN ketorolac has been     understudied in children, and it is not known how effective it is compared to IV ketorolac,     which is currently the most common way of administering ketorolac to children. If IN     ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable     and painless alternative to effectively treat acute migraine headaches in children.      Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV     ketorolac for reducing pain in children with acute migraine headaches.   "
70830|NCT02358668|"     This is a single-centre, 16-week, randomized, double-blind, placebo-controlled, 3-treatment     arm pilot study to evaluate the efficacy and safety of BTI320 in the treatment of high risk     subjects with pre-diabetes.      This is a pilot study aiming to test whether taking a medicine named BTI320 that slows down     carbohydrate absorption in the gut, will lower blood sugar. The study aims to recruit 60     individuals in Hong Kong. To take part in the study, subjects must have pre-diabetes, that     is, they have blood sugar levels that are above normal but not reaching diabetes range. The     medicine BTI320 is currently licensed as a health supplement in Hong Kong and is known     alternatively as SUGARDOWN®. The investigators are comparing the effectiveness of BTI320     against a dummy tablet. Both tablets look and taste identical and during the study, subjects     will not know which of these tablets they are taking. There is a 4 in 5 chance of receiving     active medication and 1 in 5 chance of receiving placebo. Subjects will be followed up     closely every 2 to 4 weeks for a period of time up to 22 weeks.      The study visits will take between 30 minutes to 3 hours, depending on additional checks that     are required on a particular visit including oral glucose tolerance test and meal tolerance     test. At visits involving meal tolerance test, subjects will be required to stay for     approximately 3 hours. In addition, at Visit 2, Visit 4 and 3 days before Visit 7, a     continuous glucose monitoring system device will be installed.      Throughout the study period, subjects will return to the study center for check-ups including     careful enquiry about whether they have developed any side-effects from taking the     medication, physical examination, as well as blood tests.   "
70831|NCT02358655|"     Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by six     times. There are several medications (blood thinners) that can prevent strokes in AF     patients. Many AF patients present to the emergency department, but about half of AF patients     leave without prescription of a blood thinner. The study aims to evaluate if adding options     like giving a patient education kit, encouraging emergency room physicians to prescribe a     blood thinner and providing a specialized AF clinic to patients will increase the number     patients receiving blood thinners to prevent strokes.   "
70861|NCT02358265|"     To compare CSU disease activity at the end of the follow up phase between patients that had     been treated daily continuously vs. on-demand in the treatment phase   "
70862|NCT02358252|"     This research investigated the heart rate variability (HRV) and stroke patients' orthostatic     hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting     angle controlled by tilting table.   "
70924|NCT02357420|"     The purpose of this study is to evaluate the effects of multiple dose regimens of RM-131 on     vomiting episodes, gastric emptying and gastroparesis symptoms in patients with Type 1 and     Type 2 diabetes mellitus and gastroparesis. Study drug (RM-131 and placebo) will be     administered subcutaneously in a blinded fashion.   "
70832|NCT02358642|"     Background: Older people with neurological dysphagia are at risk of recurrent aspiration     pneumonia. Angiotensin converting enzyme inhibitor (ACEI) has been shown to improve     swallowing and cough reflexes which may protect dysphagic patients from aspiration pneumonia.      Hypotheses: ACEI reduces the risk of pneumonia in older patients who are nasogastric tube fed     because of dysphagia from cerebrovascular diseases.      Design: Randomized placebo controlled trial      Method: 302 older patients who have been tube fed for more than two weeks because of     dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5     mg or placebo tablet once daily for 26 weeks. The subjects will be recruited from medical     wards in Prince of Wales and Shatin Hospitals, and from outpatients of geriatric or speech     therapy clinics, who have had hospital stay in previous three months. The subjects are     followed up at week 12 and 26. The primary outcome is the incidence rate of pneumonia as     determined by pneumonic change on X ray and clinical criteria. The secondary outcomes are     mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by     the Royal Brisbane Hospital Outcome Measure at week 12. Cost effectiveness analysis of public     health care and personal health care costs will be performed. Intention to treat and log rank     will be used to analyzed the group differences in outcomes. 60 subjects (30 in each trial     group) recruited from medical inpatients at Prince of Wales Hospital will undergo swallowing     videofluoscopy at baseline and week 12 follow-up.   "
70833|NCT02358629|"     Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to     providing additional guidewire support that is expected to allow easier crossing of     femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will     be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires     revascularization.   "
70834|NCT02358616|"     This study is primarily exploratory and is designed to both identify factors that may have     affected participant adherence to study product in VOICE, and describe how sexual behaviors,     such as anal sex, may have had an effect on product efficacy. As such there is no specific     hypothesis that is being tested.   "
70835|NCT02358603|"     This study is to collect human activity and ECG data from heart failure (HF) patients to aid     in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose     CI in patients with HF.   "
70836|NCT02358590|"     This pilot study evaluates the effect of theory menu-based mini-videos on vitamin D adherence     in older adult with osteoporosis. Half of participants will watch the videos while the other     half will receive usual care (treating physician advice).   "
70839|NCT02358551|"     The intrathoracic subclavian venous technique for pacemaker implantation may be associated     with serious complications. Axillary vein puncture tends to reduce lead implantation     complications such as pneumothorax and lead crush, but clinical adoption is not widely     acknowledged, especially in China, although this approach has been proposed for 20 years. The     major concern is the learning curve for axillary vein puncture and its success rate. The     investigators try to prove that the success rate of axillary vein puncture is non-inferior to     subclavian vein puncture, hence to promote the clinical application of axillary vein puncture     to reduce pacemaker implantation complications.   "
70840|NCT02358538|"     To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled     seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an     open-label proof-of-concept study.   "
70841|NCT02358525|"     The aim of this descriptive study is to examine potential changes regarding inflammatory     cytokine levels, depressive symptoms and quality of life over the course of the 4-week     inpatient rehabilitation program which includes a cassette of modalities including     counseling, psychosocial education and supervised exercise training as a main pillar, and to     further investigate if there are correlations between changes in immune regulation,     depressive symptoms and quality of life.   "
70842|NCT02358512|"     The purpose of this study is to determine whether intermittent nasogastric enteral feeding,     rather than conventional continuous enteral feeding, will preserve muscle mass in the     critically ill (Primary end-point). Such maintenance may translate into improved outcomes     including reduced length of intensive care unit (ICU) and/or hospital stay, as well as number     of days on a ventilator. In addition, long-term improvements in health-related quality of     life and physical activity levels may result in these ICU survivors once they are back in the     community. Indeed, such benefits could translate into reductions in primary healthcare usage     and its related costs (secondary end-points).   "
70843|NCT02358499|"     The main goal of this study is to see how the body breaks down an antifungal drug named     posaconazole in children with certain cancers, blood disorders, or transplantation of bone     marrow or similar blood cells. This study will also help us learn whether a child's age,     genetics, or disease affect how well the body breaks down posaconazole.   "
70844|NCT02358486|"     The aim of the study is to investigate the effect of acupuncture on functional dyspepsia     compared with sham control. The study aims to clarify the mechanism of acupuncture by     assessing functional magnetic resonance imaging and metabolomics.   "
70845|NCT02358473|"     The purpose of this study is to evaluate the safety of mogamulizumab in combination with     docetaxel in adult subjects with previously treated locally advanced or metastatic non-small     cell lung cancer.   "
70846|NCT02358460|"     A randomised controlled trial comparing volume-targeted ventilation to pressure-limited     ventilation in infants born at or near term.   "
70847|NCT02358447|"     By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we     want to show wich method has the better outcome.   "
70874|NCT02358096|"     The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin     to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic     Kidney Disease (CKD) at 12 weeks compared to placebo.   "
70848|NCT02358434|"     The proposed study is a retrospective, observational study. A group of 5 subjects with the     AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed     during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair     and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed     tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and     ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate,     bring to market and advance the implant. Furthermore the information will be integrated in a     model, which will be developed at the Center for Orthopaedic Engineering, University of     Denver. By means of this model, different conditions such as the use of an advanced     prosthesis design can be simulated and tested.      The objective of this study is in a first step to demonstrate the capability of data     collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing up     from a chair and stair descent on a limited sample size of five subjects. Secondly to     quantify and describe the three-dimensional kinematics for the cruciate retaining (CR), fixed     bearing AttuneTM TKA during daily activities such as those mentioned.   "
70849|NCT02358421|"     Polycystic ovarian syndrome (PCOS) patients have an increased risk of ovarian     hyperstimulation syndrome (OHSS) after assisted reproduction techniques (ART). In addition,     these women have a high risk of develop further metabolic disorders. Rotterdam criteria     defined by the European Society of Human Reproduction and Endocrinology (ESHRE) are used for     the diagnosis of PCOS.      The aim of this study is both to determine the prevalence of PCOS in infertile patients who     require ART in our Center and to evaluate the usefulness of each specific diagnosis criterium     within Rotterdam criteria of PCOS as predictor of risk of OHSS. It also seeks to establish a     cohort of patients identified according to specific Rotterdam criteria of PCOS to assess the     incidence of long term complications.   "
70850|NCT02358408|"     The study consists of 2 parts:      The objective of part 1 of this study is the performance of a short evaluation of system     accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to     be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure     that the Karajishi meters are fully functioning, assure and document the accuracy of the     comparison method, evaluate and validate the processes and procedures of the study     methodology. The objective of part 2 of this study is the evaluation of system accuracy     following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test     procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose     by patients are stipulated.      This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer:     Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.   "
70851|NCT02358395|"     This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib.     This study population is adult Japanese patients with advanced hepatocellular carcinoma in     Sorafenib combination therapy.   "
82891|NCT02201030|"     This study will assess the immunogenicity and safety of primary vaccination with NBP606     compared to the existing commercial vaccine, when given concomitantly with routine pediatric     vaccinations.   "
70855|NCT02358343|"     Patients whose kidneys fail generally require dialysis treatments to sustain life. The     ability of patients to make major adjustments in their lives for dialysis is hampered by     depression that affects almost one-quarter of such individuals. There are no studies that     have adequately tested whether treatment of depression is effective in dialysis patients and     if there is any difference between the response to the two most commonly available forms of     treatment, psychotherapy and anti-depressant drug therapy.      To fill this important gap in the investigators knowledge, the investigators propose to     undertake (1) a randomized controlled clinical trial of 200 patients to test whether an     engagement interview will result in a higher proportion of dialysis patients accepting     treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to     determine whether there is any difference in the likelihood of improvement of depressive     symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients     in these studies will be enrolled from among individuals receiving care in 50 dialysis     facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research     proposal has been developed with the support of patients, caregivers, and stakeholders to     ensure that the findings from the study are relevant to them and can be readily implemented     in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be     delivered in a dialysis facility to ease the burden on patients, and the dose of the study     drug will be changed in partnership with the study participants. In addition to depressive     symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will     be determined.      The two forms of treatment for depression being tested in this clinical trial are very     different from each other and patients differ with regards to the treatment option preferable     and/or available to them. Successful completion of the clinical trial will provide patients,     caregivers, and other stakeholders with the information that they would need when faced with     a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to     select evidence-based treatments to improve outcomes that are relevant to them.   "
70856|NCT02358330|"     Smoking is the leading preventable cause of cancer mortality in the US. Despite its profound     health and economic costs, smoking treatment is infrequently provided in healthcare settings,     and when provided, it is not sufficiently effective. To address this, this project will     develop and evaluate more efficient electronic health record (EHR) methods to identify     smokers and engage them in evidence-based treatment.   "
70857|NCT02358317|"     The purpose of this pilot study is to determine whether a video-game based motor training can     affect postural stability, daily living skills, autism symptoms, and white matter     microstructure of the corticospinal tract in adolescents with Autism Spectrum Disorder (ASD).   "
70858|NCT02358304|"     The main objective of this randomised clinical trial is to is to compare the frequency of     recurrence between patients who received nasal spray calcitonin after curettage of Central     Giant Cell Granuloma and without it.   "
70859|NCT02358291|"     In our study, a multicenter randomized controlled，single blind trial will be performed to     evaluate the effectiveness and safety of these three procedures for the treatment of     symptomatic lumbar disc herniation.   "
70863|NCT02358239|"     Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department     (ED). Pharmacological therapy is often solicited for these symptoms, such as vestibular     suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with     unavoidable side-effects. To the best of the investigators knowledge, no papers surveyed     assess the feasibility of applying acupuncture as an emergent intervention means to the     treatment of dizziness and vertigo. The investigators study targeted on filling in this gap     by performing a clinical control trial to evaluate the efficacy and safety of traditional     Chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ED.   "
70864|NCT02358226|"     The purpose of this study is to test the efficacy of randomizing all young men in a     neighborhood to receive: 1) soccer training; 2) soccer and vocational training; or 3) a     control condition, as a means to engage young men in HIV prevention. The investigators     hypothesize that the intervention will reduce young men's substance use and increase HIV     testing.   "
70865|NCT02358213|"     This aim of this study is to compare the reproducibility of reading of five international     experts concerning the anomalies of the salivary glands.      The reproducibility is measure on patients and not on recorded data.   "
70866|NCT02358200|"     Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the     safety of the combination of BMN 673 and carboplatin, and subsequently BMN 673 in combination     with paclitaxel and carboplatin to determine the recommended Phase II dose of the     combination.   "
70867|NCT02358187|"     The study will assess the immunogenicity, safety and preliminary clinical efficacy of the     GAA/TT-peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas     that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as     one biologic regimen, but patients may not have received radiation to the index lesion within     1 year of enrollment.   "
70868|NCT02358174|"     An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been     described previously. MMPs regulate extracellular structural proteins and tissue remodeling.     Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP     activity. The aim of this work was to study the relationship between the levels of MMPs and     NGAL and different stages hemorrhoids.      The study provides potentially important insights to the understanding of the natural history     of Hemorrhoids and MMPs and NGAL regulation.   "
70869|NCT02358161|"     The 5 year survival of patients with locally advanced or metastatic pancreatic cancer is less     than 5 %. Since the introduction of gemcitabine, further advances in therapy in the     advanced/metastatic setting have been extremely slow. Numerous phase III studies have     evaluated different gemcitabine-based regimens as first-line therapy, but in most cases, any     observed benefits have been small and restricted to patients with a good performance status     (PS). Recently two new chemotherapy combination schedules, FOLFIRINOX and Gemcitabine +     nab-paclitaxel demonstrated a significant survival improvement compared to gemcitabine alone.     Nab-paclitaxel is especially interesting because it is able to break-down the tumor matrix     and increases the concentration of cytotoxic drugs in the tumor.      Our study will explore the modification of the desmoplastic reaction seen in pancreatic     cancer using two approaches, targeting tumor stroma by nab-paclitaxel and the hedgehog     inhibitor LDE225 and targeting the tumor cells with gemcitabine and nab-paclitaxel.   "
70870|NCT02358148|"     This prospective observational study will evaluate and compare the sensitivity and     specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the     presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during     coronary angiography in the cardiac catheterization suite. In addition, we plan to determine     if a variant of SACS, HEART, TIMI, or a hybrid score resulting from combining formulas from     two or all three scores yields a new tool that exceeds the predictive performance of all     three current models for determining the absence or presence of OCAD.   "
82915|NCT02200718|"     A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple     Sclerosis to demonstrate safety & efficacy   "
70871|NCT02358135|"     The investigators propose to evaluate whether an innovative collaborative connected health     (CCH) model increases access to specialists and improves patient outcomes. CCH offers     multiple modalities for patients and primary care providers (PCPs) to access dermatologists     online directly and asynchronously to maximize effectiveness in a real-world setting. CCH     also fosters team care and patient engagement through active sharing of management plans and     multidirectional, informed communication among patients, PCPs, and dermatologists. The     specific aims of the proposal are to (1) determine whether the CCH model results in     equivalent improvements in psoriasis disease severity compared to in-person care, (2)     determine whether the CCH model results in equivalent improvements in quality of life and     mental health compared to in-person care, and (3) assess whether the CCH model provides     better access to care than in-person care.   "
70872|NCT02358122|"     A dietary intervention study designed as a randomized, controlled, parallel intervention of     6-weeks duration. A total of 75 participants will be included in the study and randomly     allocated to one of three interventions (refined wheat, whoelgrain wheat or wholegrain rye).     Clinincal examinations including anthropometric assessment, fecal, urine and fastign blood     sampling, dietary assessment and a meal challenge will be done before (week 0) and after     (week 6) the intervention. At timepoints week 0, 2, 4 and 6 questionnaires will be filled in     concerning satisfaction with diet and gastrointestinal symptoms.   "
70873|NCT02358109|"     Spain is the second country in the world that consume more drugs. The average drug     expenditure per capita in Andalucía during 2011 was 219.2 €. This drug spending increases     during the perimenopausal period. According to the Study of the Economic Impact of Sport on     Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro     invested in sports promotion 50 euros are saved in health spending accumulated over 15 years.     The main objectives of this project are: i) To analyze the (cost-effectiveness) effect of an     exercise program on the prescription of drugs in a sample of Andalusian women aged 45-60     years. ii ) To study the level of physical activity and sedentarism (measured objectively by     accelerometry ) , functional capacity , quality of life and clinical profile of this     population. iii ) To analyze the relationship between levels of physical activity /     sedentarism and pharmaceutical expenditure. In the present project, an exercise program aimed     at minimizing symptoms and health problems associated with the perimenopausal period will be     performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of sleep,     obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal women will     be randomly assigned to the intervention group exercise (n = 80 ) or to the usual care group     (n = 80). Participants in the intervention group will train 3 days / week ( 60 min per     session ) for 16 weeks.      With the analysis of the results of this project new patterns of objective work as well as     the most significant practical resources for the design of a master plan may be determined.     Results are expected to be able to shed some light on the implementation of programs of     health promotion that are both time beneficial for the Andalusian Public Health and for the     family , institutional and community economy.   "
70876|NCT02358070|"     The purpose of this study is:        -  to investigate the risk factors of HCC among Americans with focus on lifestyle factors          and energy balance.        -  to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated          with HCC risk through a genome-wide search.        -  to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle          factors, and to explore if there are interplays or effect modifications between genetic          factors and viral infection or lifestyle factors.   "
70877|NCT02358057|"     The main objective is to determine if dexmedetomidine combine with alfentanil allow a level     of conscious sedation within maximum security conditions in an emergency department.      Patients included in the study will receive an injection of dexmedetomidine via a TIVA     Injectomat Agilia, specially programmed for the injection of dexmedetomidine.      Patients will also receive a dose of alfentanil, 1 minute before the technical act.   "
70878|NCT02358044|"     This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with     sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) [PR] treatment in     treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus     (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy     (assessed by the percentage of participants achieving sustained virologic response 12 weeks     after ending study treatment [SVR12]) and safety between the grazoprevir plus elbasvir     treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the     percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is     non-inferior to that in the SOF plus PR treatment arm.   "
70879|NCT02358031|"     Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck     (HNSCC) will be randomly assigned to receive pembrolizumab alone, or pembrolizumab + a     platinum-based drug (cisplatin or carboplatin) + 5-Fluorouracil (5-FU), or cetuximab + a     platinum-based drug (cisplatin or carboplatin) + 5-FU. The primary study hypothesis is that     pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free     survival and overall survival compared to standard treatment.   "
70880|NCT02358018|"     The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan,     instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor.     68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the     USA, with better tumor detection than with OctreoScan.   "
70881|NCT02358005|"     Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal     shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the     management of post-stroke spasticity of the upper limb. However, it was not determined which     dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in     patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of     ESWT after botulinum toxin type A injection for post-stroke spasticity   "
70882|NCT02357992|"     The goal of this clinical research study is to evaluate the outcome of a standard radiation     treatment called stereotactic radiotherapy (SRT) for NSCLC.      Specifically, researchers want to learn if standard SRT has as good of an outcome at 3 years     after the procedure. The safety of the study treatment will also be analyzed.   "
70883|NCT02357979|"     The objective of this clinical study is to evaluate whether the use of the new CO2 - 9.3μm     short-pulsed laser increases the caries resistance of occlusal pit and fissure surfaces in     patients in addition to fluoride therapy. This will be quantified by visual exams with the     International Caries Detection and Assessment System (ICDAS II), SOPROLIFE daylight and blue     fluorescence, and DIAGNOdent Laser Light-induced Fluorescence. This is a randomized, single     blind, prospective, split mouth controlled, clinical trial over 12 months.   "
82916|NCT02200705|"     To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and     distant recurrence of early stage breast cancer .   "
70885|NCT02357953|"     Perioperative hemodynamic optimization requires monitoring adapted to the risks of the     surgery and the patient. The investigators currently use a local hemodynamic protocol based     on the data of the literature. According to this protocol, specific patients may require     cardiac index and central venous oxygen saturation monitoring. the investigators chose to     monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD)     (PiCCO, Pulsion Medical System, Munich, Allemagne). The technique is based on the injection     of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The     variation of temperature is measured with an arterial femoral catheter and allows the     assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed     the reliability of this technique (Bein J Cardio Thorac Vasc Anesth 2004, Buhre Cardio thorac     vasc anesth 1999, Felbinger J Clin ANesth 2005, Felbinger TW J Clin Anetsh 2002, Godie O Ann     Thorac Surg 1999).      In our institute, most of the patients are fitted with a port for chemotherapy or parenteral     nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the     opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be     more difficult because of the port. It may be interesting to use the port for TPTD in order     to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by     the port was as reliable as the classical measurement with a CVC.      The aim of this study was to assess whether measurement of the CI by TPTD was possible and     reliable via the port. The investigators conducted a prospective study comparing the     measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.   "
70886|NCT02357940|"     The purpose of this 14-day, two phase clinical study is to test the tolerance of a new     over-the-counter moisturizing balm on subjects with eczema.   "
70887|NCT02357927|"     This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in     breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services     (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by     the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4     item measure and the EORTC Intervention overall satisfaction scale.   "
72365|NCT02338531|"     This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic     triple-negative breast cancer patients with residual disease (cHEmoresistant) after     completion of standard neoadjuvant chemotherapy.   "
70888|NCT02357914|"     Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level     paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level     paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the shoulder     during routine daily activities, the onset of pain or injury lead to increased healthcare     expenses, limitation in activity, depression, decreased participation, and reduced quality of     life. One of the main reasons of shoulder pain is believed to have a altered scapular     movement. To clarify the mechanism of the shoulder pain and injury, comprehensive     understanding of three-dimensional scapular kinematics is required. Ultrasound is a low-cost     and non-invasive imaging system and has been used to diagnose the shoulder pain and injury in     individuals with SCI. A freehand ultrasound (FUS) combining ultrasound with motion capture     system to evaluate scapular movement was developed and presented favorable results in     able-bodied population. The purpose of this study is to compare the FUS and widely used     skin-based method against a radiographic based gold standard in people with paraplegia, and     to elucidate the relationship among scapular movement and shoulder pain, pathology. This     study will also allow us to gain more understanding of how level of injury influences the     scapular behavior during functional activities. The investigators believe more severe     shoulder pain and pathology will be associated with greater abnormal scapular movement. The     investigators also believe that people with high-level paraplegia will have greater scapular     abnormality than people with low-level paraplegia during arm elevation and weight relief     raise tasks. By completing this study, the investigators will expect to deliver a reliable     and valid tool to evaluate scapular movement and gain a better understanding how the altered     scapular movement is related to shoulder pain and pathology. The investigators will also     learn how the level of injury affects the scapular behavior during functional activities. The     results of this study may help the shoulder pain management leading to the improvement in the     quality of life of individuals with SCI.   "
70889|NCT02357901|"     This is a randomized, double-blind, placebo controlled, multisite study in male and female     participants who are seeking treatment for opioid use disorder.   "
70890|NCT02357888|"     The purpose of this study is to evaluate the reduction of craving and its time course after     administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.   "
70891|NCT02357862|"     The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on     the geometry and the function of the tricuspid valve complex.   "
70892|NCT02357849|"     We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with     aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate     severity.   "
70893|NCT02357836|"     The purpose of this study is to determine the pharmacodynamics effects of itraconazole in     early-stage non-small cell lung cancer.   "
70894|NCT02357823|"     Streptococcus pneumoniae is a cause of high morbidity and mortality in HIV-positive subjects,     representing the leading etiological agent of severe bacterial pneumonia. International     guidelines recommend that HIV positive patients aged >=19 years, who are 13-valent conjugate     vaccine (PCV13) naïve, should receive a single dose of PCV13. Pneumococcal polysaccharide     vaccine 23-valent (PPV23) should be given >=8 weeks after indicated dose of PCV13, and a     second dose of PPV23 should be given 5 years later. For those who previously received PPV23,     PCV13 should be administered >=1 year after the last PPV23 dose. HIV infection affects     humoral immunity both through reduced T-cell help and changes in the B-cell compartment.     Neither amount of circulating memory B cells nor their functions are restored by     antiretroviral therapy: this may affect antibody mediated immunity, even in well-treated HIV     patients. In asplenic childrens a single dose of PCV13 seems sufficient to restore the pool     of anti-pneumococcal polysaccharides IgG memory B cells. In adults, it has been reported that     a single dose of 7-valent pneumococcal conjugate vaccine induces significant increases in     serotype-specific memory B-cell populations, conversely, immunization with PPV23 seems to     decrease memory B-cell frequency. However, data on immunological response after PCV13 in HIV     positive adults are still scanty and the optimal pneumococcal prophylaxis strategy needs     further investigation. Number of PCV13 doses is actually demanded to clinical judgment for     each patient; also current Italian indications recommend at least one dose, but till 3 doses     seem to be suggested for immunocompromised patients. Present study aims to investigate short     and long term immunological response after different standard vaccine schedule and to     evaluate pneumococcal nasopharyngeal colonization in vaccinated patients.   "
70895|NCT02357810|"     The purpose of this clinical research study is to learn if pazopanib when given in     combination with topotecan can help to control sarcomas. The safety of this drug combination     will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
70896|NCT02357797|"     This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study     comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88     stable patients with a research diagnosis of schizophrenia determined with the Structured     Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness     duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining     whether earlier illness moderates greater negative and /or cognitive symptom reduction in     response to vortioxetine.   "
70897|NCT02357784|"     Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence     (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction     than those with just UI or FI. In many situations, DI is the result of a failure of     communication between the brain and the sacral nerve, which controls the bladder, bowel, and     pelvic floor. The only currently available treatment with level 1 effectiveness data for the     treatment of BOTH UI and FI is called Sacral Neuromodulation (SNM). Sacral Neuromodulation is     a standard of care treatment that involves surgically implanting a device in to a patient's     body to target communication issues between their brain and bladder/bowel. Because the exact     mechanism of action of SNM remains unclear, this study aims to better understand how SNM     affects the nerves of patients with DI. Patients who are already planning on undergoing SNM     device implantation will be recruited to this study. Study participants will undergo Current     Perception Threshold (CPT) Testing and fill out questionnaires before SNM and 3 months after     their SNM treatment. CPT Testing uses mild electrical stimulation in the urethra and rectum     to measure and quantify the amount of physical stimuli required for the nerves in the pelvic     floor to sense a stimulus. By learning more about nerve function in patients with DI, the     investigators hope to find a way to screen patients before treatment with SNM to make sure     the treatment will be effective for that individual.   "
70898|NCT02357771|"     Advances in orthodontics have improved the quality of appliances and treatment protocols,     raising the standard of patient care. However, enamel demineralization is still a problem     associated with orthodontic treatment, leading to the formation of white spot lesions; this     is a grave concern to orthodontists and patients.      The overall prevalence of white spot lesions among orthodontic patients has been reported to     be between 4.9% and 84%.1 When basic oral hygiene is poor, orthodontic appliances create     areas of plaque stagnation, especially around brackets, bands, wires, and other attachments.     Levels of acidogenic bacteria, present in the plaque, notably Streptococcus mutans (S     mutans), are higher in orthodontic patients than in non-orthodontic patients.      This causes demineralization around the brackets and leads to white spot lesions. They are     most prevalent around the cervical region of bands in the posterior region, whereas in the     anterior region, the lateral incisors in both arches, followed by the canines, are most     commonly affected.   "
70899|NCT02357758|"     Approximately, 3% of males and 8% of females will develop a urinary tract infection (UTI)     during childhood, and most of these will be effectively treated by short-term antibiotic     therapy. A subset of these children (20-48%), will develop recurrent UTI (RUTI), which may     have long-term effects in the form of hypertension or renal damage.      In an effort to prevent RUTIs physicians prescribe sulfamethoxazole-trimethoprim (Septra) or     nitrofurantoin as low dose antibiotic prophylaxis. However, recent evidence suggests that     during prophylactic therapy the body is exposed to antibiotic levels capable of increasing     antibiotic resistance and bacterial virulence. This has been shown to be true in the     uropathogens E. coli and Staphylococcus saprophyticus, yet it is not known if Enterococcus     sp. demonstrate similar mechanisms. Additionally, antibiotics have been shown to disrupt the     natural balance of the human microbiome, potentially leading to major long term problems.      As a uropathogen, enterococci consistently rank in the top 3 causes of RUTI, especially in     children under 3 years of age. Additionally, Enterococcus is notorious for developing     antibiotic resistance and studies have shown that children with enterococcal UTIs exhibit a     higher rate of recurrence than those with non-enterococcal UTIs.      The investigators hypothesize the current practice of antibiotic prophylaxis in children with     RUTI is detrimental and can change the bacterial and sensitivity profiles of these patients.   "
70900|NCT02357745|"     Neopterin has been identified as a marker of cellular immune system activation. It is     synthesized by macrophages upon stimulation with the cytokine interferon-gamma and is     indicative of a pro-inflammatory immune status. Neopterin concentration increases with     increasing severity of periodontal disease in diverse body fluids like Urine, Saliva and     Plasma. Hence Neopterin can be considered as an important inflammatory marker in periodontal     disease as well as other systemic diseases.   "
70901|NCT02357732|"     This study evaluates nivolumab in combination drug treatments involving 1) nivolumab and     dabrafenib 2) nivolumab and trametinib and 3) nivolumab, dabrafenib and trametinib in     patients with BRAF or NRAS-mutated metastatic melanoma.   "
70902|NCT02357719|"     The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in     adults is now well documented as well as its cardiovascular repercussions. Previous studies     showed a conclusive link between SAHS and severe cardiovascular diseases such as     hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health     issue in adults.      In this context, early detection of such a disease is crucial if the management is tailored     to the patient, the practitioner's choice of therapy moving towards continuous positive     airway pressure (CPAP) or mandibular advancement device. The detection is based on full     nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold     standard but it is a time consuming and costly examination. Polygraphic recording is a test     that allows simplified the diagnosis of severe patients, but may not be sufficient for mild     form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation     of a technique for identifying patients most at risk to either limit the number of     polysomnographic examination is requested.   "
70903|NCT02357706|"     Little is understood about how different auto-adjusting PAP devices operate. The purpose of     this evaluation is to compare two devices in a randomised two night PSG trial.   "
70904|NCT02357693|"     The purpose of this study is to determine whether patients at high risk for postoperative     nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the     perioperative period.   "
70905|NCT02357680|"     This study will investigate the effect of diaries written by relatives for critically ill     patients on the risk of posttraumatic stress symptoms.      Utilizing a randomized controlled design pairs of one patient and one relative will be     assigned to either diary intervention or standard care. The effect of the diary will be     evaluated using a questionnaire 3 months post charge.      The results of this study will add to the body of knowledge on how diaries may help critical     care survivors and their relatives to proceed with their lives.   "
73447|NCT02324387|"     The goal of this clinical research study is to compare Tc99m sestamibi molecular breast     imaging (MBI) scans to mammograms and ultrasounds (the current standard of care) to learn if     MBI scans can measure if the disease is responding to chemotherapy.   "
70906|NCT02357667|"     This study will evaluate the differences in cardiovascular parameters between women with     severe preterm preeclampsia and those without preeclampsia using echocardiography and     maternal blood. The investigators will also look at associations of abnormal cardiovascular     findings and immediate complications among a high risk cohort of pregnant African American     women.   "
70907|NCT02357654|"     During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days     after fertilization. For a successful pregnancy to take place, that embryo must then implant     in the properly primed and staged endometrium, which subsequently must continue to develop to     accommodate the growing and maturing embryo and then fetus. This process is normally     regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has     been found that after IVF additional support for the endometrium with progesterone improves     implantation and subsequent live birth rates in IVF cycle . Recent data has shown that     additional supplementation with a single administration of a GnRH agonist around the time the     time of embryo transfer may further enhance these rates .   "
70908|NCT02357641|"     Examination of probable distinction between cardiac or non- cardiac thoracal disorder via     echocardiographic myocardial strain analysis   "
70909|NCT02357628|"     The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT)     will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal     soft tissue wounds.   "
70910|NCT02357615|"     The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran)     with nifedipine controlled-release tablets (Adalat）in the treatment of Early Morning Blood     Pressure and Central Arterial Pressure.   "
70911|NCT02357602|"     Purpose:      The purpose of this study is to characterize the dose-proportionality in the distribution of     tenofovir alafenamide (TAF) and tenofovir (TFV) in plasma and mucosal tissues, and     TFV-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) and mucosal tissues of     healthy female subjects following a single oral dose of GS-7430 at 5mg, 10mg, and 25mg.   "
71011|NCT02356276|"     The purpose of this study is to study the efficacy of hyperthermic intraperitoneal     chemotherapy in the treatment of patients with locally advanced gastric cancer after radical     gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.   "
70912|NCT02357589|"     The 3D-systems have emerged also to the world of surgery, and the three-dimensional     laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy     there are only two-dimensional view, which is somewhat challenging when operating in     three-dimensional environment. Even though the 3D-systems have been widely studied in     laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical     point of view and no prospective randomized trials have been published. Therefore, the     purpose of this study is to investigate is there something to gain in changing into 3D     laparoscopic system for cholecystectomy (LCC).   "
70913|NCT02357576|"     Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated     with significant morbidity and mortality in neonates and is felt to be exacerbated by     soybean-based lipid emulsions. Much research is currently being directed at identifying ways     to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of     parenteral nutrition is one possible strategy. In this study we will compare standard dosing     of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for     the development of cholestasis and adequate growth between the two groups. Longterm followup     will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.      Funding source - FDA OOPD   "
70914|NCT02357563|"     Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia,     abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more     surgeries due to their particular position in the myometrium. Surgery, moreover, should     always be tailored, particularly in patients wishing to conceive, to preserve the integrity     of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in     patients with submucous fibroids, but are associated with several side effects. the eighty     percent of patients treated by UPA showed a clinically meaningful reduction of more than 25%     in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared     to be maintained for 6 months after the end of UPA treatment   "
70915|NCT02357550|"     This project tend to investigate the affection of ketone bodies on brain metabolism. This     will be done by measuring human cerebral uptake of energy substrates, together with     functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in     healthy subjects by ketone infusion.      Hypotheses        1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake          by brain cells contributing to hyperglycaemia.        2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood          flow.        3. Altered oxygen consumption during hyperketonemia in healthy subjects.   "
70916|NCT02357537|"     This study is designed to assess differences in remote and on-site patient study     participation in the State of Massachusetts, as well as the significance of dietary     interventions and their impact on UC. The study will activate one site with a Principal     Investigator who will utilize each subject's local care system (local Gastroenterologist) to     collect study data, along with telemonitoring and video visits, to make key study assessments     and decisions regarding subjects' progression in the study.   "
70917|NCT02357524|"     The study will determine the magnitude and duration (time to resolution i.e., returning to     normal ranges) of elevations in the following coagulation test results after a single 1200 mg     dose of oritavancin: Prothrombin Time/International Normalized Ratio (PT/INR), Activated     clotting time (ACT), Activated Partial Thromboplastin Time (APTT), Chromogenic Factor Xa     Assay, D-dimer, Silica Clot Time and Dilute Russell's Viper Venom Time (DRVVT).   "
70918|NCT02357511|"     The study aims to define the sensitivity and specificity of a novel continuous noninvasive     blood pressure monitor.   "
70931|NCT02357316|"     The investigators seek to determine how genetics and the environment influence the ability to     taste and smell fat. The investigators believe that people who consume higher fat diets and     people who have higher body fat levels are less able to taste and smell fat. The     investigators expect to see that people who are less able to taste and smell fat will share     certain genetic differences.   "
70919|NCT02357498|"     The purpose of this research study is to compare the extent of resection (EOR) in patients     with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a     microsurgical technique to those patients who have undergone surgery with a fully endoscopic     technique. Another goal is to compare surgical complications, endocrine outcomes, visual     outcomes, length of surgery, length of hospital stay, and readmission rates between the two     transsphenoidal surgery techniques. This is an observational data collection study with no     experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a     pituitary tumor is a unique procedure and there is little information comparing the two     surgical techniques.   "
70920|NCT02357485|"     This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the     stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade     I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under     Institutional Review Board (IRB) approved protocol.   "
70921|NCT02357472|"     The supplementation of Dehydroepiandrosterone (DHEA) has been used in some centers for     patients with previous poor ovarian reserve and response in an attempt to improve pregnancy     outcomes. However, there still has controversy on the clinical effect on the 75mg/d for the     use,especially in Asian people. Whether the double dosage of DHEA in patients with poor     ovarian reserve and response in China can improve the IVF outcome with little side effect is     unknown.      The aim of this randomized controlled study is to compare the effect of a higher dose (150mg     daily) and a standard dose (75mg daily) of DHEA on the number of oocytes obtained in poor     ovarian responders. The effect of DHEA action on the cumulus cells will be examined.   "
70922|NCT02357459|"     This study is a double-blind, randomized, single-dose study to assess the safety and efficacy     of FX006 for the treatment of pain in patients with osteoarthritis of the knee.      Approximately 450 patients with OA of the knee will be randomized to one of the three     treatment groups (1:1:1) and treated with a single intra-articular (IA) injection of:        -  32 mg of FX006        -  40 mg of Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in          protocol)        -  Normal Saline      Each patient will be evaluated for a total of 24 weeks following a single IA injection.     Following screening, safety and efficacy will be evaluated at 7 out-patient visits (Days     1[Baseline], Weeks 4, 8, 12, 16, 20, 24).   "
70923|NCT02357433|"     The study objective is to clarify whether the application of high doses CPFA (Coupled     Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce     hospital mortality in septic shock patients in intensive care unit (ICU).   "
71029|NCT02356042|"     The study aimed to compare the changes in health and functional status between nursing home     residents practicing GIA activity and a control group of residents, and to examine the     changes in residents' abilities to participate in GIA activity.   "
70925|NCT02357407|"     Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat     infections. Their efficacy has been shown to be linked to the ratio area under the curve     (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the     bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an     AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to     40% in patients with an AUC/MIC below this threshold. These results have been reproduced     recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to     the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related     with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of     potential interest, particularly in case of severe infections (intensive care unit (ICU)     patients) or complicated and cost-related infections (osteoarticular infected (OAI)     patients), with an increasing level of evidence of its use.      However, FQ TDM requires access to the full AUC of the drug with the need of many samples     drawn to patients. This appears to be irreconcilable with clinical practice but can be     achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating     pharmacokinetic parameters of the drug by introducing covariates (demographic, biological,     clinical…) and modelling inter-individual pharmacokinetic variability. The model created     allows then accessing to individual parameters of patients and thus, estimating     concentrations and AUC of the FQ. This approach may also be used in clinical practice to     determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum     of samples.   "
70926|NCT02357381|"     A multi-center, prospective, non-randomized, single arm, open label, post-market,     observational study to evaluate the use of the eneura, springtms system in reduction of     migraine headache symptoms.   "
70927|NCT02357368|"     This is a prospective cohort study focusing on HIV negative women. The investigators want to     learn how the following types of contraceptive methods: Depot medroxyprogesterone acetate     (DMPA), Etonogestrel impant (Eng-Implant) and Levonorgestrel intrauterine device (Lng-IUD)     impacts the vaginal immune environment   "
70928|NCT02357355|"     Charcot Marie Tooth 1A (CMT 1A) is a common inherited disorder of the nerves in the body. The     disease can result in difficulties with strength and balance as well as in foot deformities     such as high arches, hammer toes, and tight ankles. Because of these difficulties, the     disease may affect driving, especially because driving requires quick responses at times such     as slamming on the brakes or turning the steering wheel quickly. The following study     determines driving performance in individuals who have CMT 1A.   "
70929|NCT02357342|"     Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and     efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular     Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular     AMD despite previous AntiVEGF treatment.   "
70930|NCT02357329|"     This study will investigate fat taste and if free fatty acids (FFA) in food function as a     signal for fat content. FFA are quite unpleasant - the investigators want to measure if the     concentration in different foods correlates with hedonic preference. FFA concentration from a     variety of foods will be used to determine if people who have greater sensitivity for FFA     find foods with higher FFA concentrations less acceptable. Further, this study with determine     whether the relationship between fat taste and hedonic food preference is modified by sex and     body mass index (BMI).   "
70977|NCT02356718|"     This study examines whether computer tasks can improve memory and other cognitive functions     among patients receiving inpatient treatment for substance use disorders.   "
70932|NCT02357303|"     The upper endoscopy is one of the most common methods for the diagnosis and treatment of     upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify     early neoplastic lesions.      Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this     fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired     by the presence of foam, bubbles or gastric mucus.      To improve visualization of the gastric mucosa, it is possible to administrate an oral     solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or     N-Acetylcysteine previously to the procedure.      The aim of this project is to determine if the use of premedication with simethicone, alone     or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI     endoscopy.   "
70933|NCT02357290|"     Children between the ages of 5-17 years old who have or display symptoms of emotional     dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited     to participate in a 12-week research study to determine the effectiveness and safety of the     natural treatment N-acetylcysteine (NAC) for children with emotional and behavioral problems.     After undergoing a comprehensive evaluation by medical doctors with a specialty in this area,     children who are found eligible to participate in this research study will be treated with     NAC. Following the evaluation period, this research study requires 12 weekly visits, either     in our office or over the phone, in an effort to closely monitor each child's response to the     medication. Eligible participants will receive study-related evaluations and weekly study     visits with our study doctors at no cost.   "
70943|NCT02357160|"     The Value of Integrating Visual Arts (VIVA): Evaluating the Benefits of Hospital Room Artwork     on Inpatient Wellbeing will use a large randomized controlled trial design to investigate how     the inclusion of visual arts in the hospital rooms of cancer patients benefits their     quality-of-life during treatment. This 18-month research study will provide hospitals with     evidence of the therapeutic value of the visual arts as measured by patients' perceptions of     anxiety, pain ratings, use of pain medications, need for nurses, and length of stay. Data     also will be collected on patients' evaluation of hospital rooms, specifically on décor     including artwork, so as to correlate patient wellbeing with the presence of artwork.     Ultimately, this project aims to increase support of and appreciation for the arts from a     major consumer—namely, healthcare providers—by justifying the value of integrating local     visual art into inpatient rooms and providing patients with aesthetic choice during their     stay.   "
70934|NCT02357277|"     There are over 10 million individuals with asthma using inhaled glucocorticoids (IGCs) in the     United States. While oral GCs are recognized to have destructive skeletal effects, far less     is known about the effects of IGCs. This gap in our knowledge is of critical importance, not     only because of the prevalence, chronic nature and long duration of IGC use, but also because     several studies have found that patients using IGCs are at increased risk of fracture.     Fracture risk is greatest in postmenopausal (PM) women, in whom IGCs may augment negative     effects of estrogen loss and aging.      The investigators hypothesize that initiation of IGCs in IGC naïve PM women will lead to     decreased bone formation and uncoupling of bone turnover, a potential mechanism for the     effect of IGCs on the skeleton.      To test our hypothesis, the investigators will perform a randomized, controlled 4 week study     of the acute effects of commonly used doses of budesonide (360 or 720 mcg) on bone turnover     and circulating osteoblast precursors in 60 treatment naïve, non-asthmatic, PM women. These     studies are of high clinical significance because there are currently no guidelines regarding     screening, prevention or treatment for osteoporosis in patients using IGCs, nor is IGC use     taken into account when calculating fracture risk in PM women, the group at highest risk of     fracture. High quality evidence for low volumetric bone mineral density (BMD) and abnormal     bone quality in PM women using IGCs has the potential to change clinical practice by     supporting specific interventions to prevent bone loss and fractures.   "
70935|NCT02357264|"     This project will study the use of ultrasound of the chest for the detection of fluid in the     lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia.     Pre-eclampsia is a syndrome usually diagnosed in the second half of pregnancy in which     patients develop elevated blood pressure and may develop protein in their urine, neurologic     abnormalities, fluid in the lungs, and abnormal blood tests associated with the liver and     kidney. Pulmonary edema (fluid in the lungs) in pre-eclampsia can lead to patient discomfort     and significant morbidity and mortality. It can be detected using chest x-ray, although this     type of imaging offers significant disadvantages, including radiation, which is of particular     concern in pregnant patients. In addition, previous studies have demonstrated that chest     x-ray is not very accurate in the detection of fluid in the lungs. Multiple previous studies     have demonstrated the utility of chest ultrasonography in detecting fluid in the chest,     although the vast majority of these studies involved patients with acute decompensated heart     failure. Our goal is to evaluate bedside ultrasound of the chest in patients with     pre-eclampsia in comparison to normal pregnant patients to determine whether these patients     have abnormal fluid in the chest.      The investigators will divide our patients into two groups. In the study group, the     investigators will include patients with pre-eclampsia with or without shortness of breath,     and in the control group, the investigators will include pregnant patients without     pre-eclampsia. Informed consent will be obtained from all patients enrolled in the study.     These patients will then undergo an ultrasound of the chest, performed by a member of the     Emergency Medicine Ultrasound Division. The images will be transmitted wirelessly from the     ultrasound machine to a secure web based cloud (Q-path) and will be subsequently reviewed by     expert reviewers.   "
70936|NCT02357251|"     This is a single-blinded randomized control trial comparing the current perioperative care of     the investigators gynecologic oncology patients with a standardized perioperative enhanced     recovery pathway. Adult patients undergoing laparotomy by one of the gynecologic oncology     surgeons will be eligible to participate. The primary outcome will be length of     hospitalization including any days of readmission in the 30 days post-operatively. Secondary     outcomes will include 30-day readmission rate, complications, quality of recovery, and pain     control.   "
70937|NCT02357238|"     In order to improve the investigators knowledge about uveitis and the underlying mechanism of     disease, the investigators propose collecting blood from patients with uveitis, isolating DNA     and sequencing the DNA to identify genetic mutations or associations in these patients.   "
70938|NCT02357225|"     Pyridostigmine is an acetylcholinesterase inhibitor, which degrades acetylcholine at the     neuromuscular junction. Based on recent studies, pyridostigmine may be an effective adjuvant     treatment for people with Pompe disease, as it increases the functional impact of this     neurotransmitter.      Hypothesis: the use of pyridostigmine in Pompe disease will improve transmission of     acetylcholine across the neuromuscular junction, skeletal muscle function, respiratory     function, and quality of life.   "
70939|NCT02357212|"     The aim of this research is to evaluate the effect of early invasive therapy and appropriate     revascularization compared with conservative management and selective revascularization among     women with an acute coronary syndrome.   "
70940|NCT02357199|"     This study aims to investigate the prevalence of oral infection in chronic renal disease     patients and to examine whether a focused oral hygiene intervention can reduce oral infection     leading to reduced systemic inflammatory parameters in chronic renal disease patients in     hemodialysis, chronic renal disease patients waiting for kidney transplantation, and chronic     renal disease patients who has been transplanted 1-1½ year previously. The results will be     compared to a gender- and age-matched healthy control group.   "
70941|NCT02357186|"     Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are     mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the     Pediatric Emergency Care Applied Research Network has published a rule clinical decision     support of mild head injury of the child with the aim to identify children at very low risk     for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary     exposure to radiation ionizing. This clinical decision rule constructed from a multicenter     prospective cohort 42,412 American children allows on anamnestic and clinical elements to     guide medical decision for conducting brain imaging, hospital monitoring or discharge home     placing the child in three levels of risk of clinically severe intracranial lesions.      Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild     head trauma the child's use of the clinical decision rule provided that it is the subject of     a validation study externally. Indeed, after the construction phase and before its daily     application, a clinical decision rule must be subject to an broad validation process so that     its predictive performance can be definitively established.      The investigators' work aims to conduct this broad validation study prospective multicenter     way in a French pediatric population, as recommended by the French Emergency Medicine     Society, in order to confirm or deny its predictive performance and allow its application and     generalization. The investigators will check and if the Rule Clinical Decision is adapted or     not to the management of mild head injuries in the French pediatric population.   "
70942|NCT02357173|"     The purpose of this study is to examine cigarette smokers' use of electronic cigarettes     (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.   "
70968|NCT02356835|"     This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the     APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.   "
70944|NCT02357147|"     This study was originally designed as a multicenter, double-blind, randomized, parallel-group     study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered     weekly, designed to evaluate the safety and efficacy of amatuximab in combination with     pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma     (MPM) who have not received prior systemic therapy.      Per a business decision made by the Sponsor, participants who were randomized to amatuximab     and are still on active treatment at the time of the protocol amendment may consent to     continue to receive weekly treatment with amatuximab until disease progression or intolerable     toxicity at the discretion of the principal investigator. Participants randomized to placebo     or who were in follow-up at the time of the amendment have been discontinued from the study.   "
70945|NCT02357134|"     The goal of this clinical research study is to learn if high-flow oxygen, low-flow oxygen,     high-flow air, or low-flow air, when given during structured exercise sessions, can help     reduce difficulty breathing in cancer patients. Researchers also want to learn if these     therapies can help to improve lung function and quality of life.   "
70946|NCT02357121|"     This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser     interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue     and to gather data for the design of future studies. Intra-procedure temperature and     concurrent rectal wall thermistor monitoring will be performed for internal validation.     Subjects will be monitored for adverse events, and health-related quality of life (HRQOL)     questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate     histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be     monitored.   "
70947|NCT02357108|"     The goal of this study is to learn what types of conversations patients prefer to have with     their doctor about treatment options and how patients view their doctor's compassion.   "
70948|NCT02357095|"     The purpose of this study is to determine whether UACE(uterine artery chemo-embolization)     followed by suction curettage under the guidance of ultrasonography or hysteroscopy can     decrease complications in the treatment of Caesarean scar pregnancy (CSP).      CSP is a special form of ectopic implantation within a fibrous tissue surrounding the     previous delivery caesarean scar. The probability of CSP is 1:1800 to 1:2,226 in all     pregnancies, and 6.1% in ectopic pregnancy after cesarean delivery. It's a long-term     complication after cesarean delivery with very serious consequences,such as uterine rupture     and massive uterine bleeding.There are more than ten methods to treat CSP,however, no     universal management guidelines have been established up to now.      Present methods for CSP treatment include:1)medical treatment,usually systemic or local     methotrexate（MTX）;2）suction curettage;3)medicine combined with uterine curettage;3）surgical     treatment（hysteroscopic,laparoscopic or vaginal surgery）;4) uterine artery     embolization(UAE);5) The combined use of the above methods.      Moreover, the rupture of the CSP and heavy bleeding may still occur following medical     treatment.Suction curettage and excision of the CSP are associated with profuse bleeding.     Surgical treatment is less micro-traumatic than nonsurgical interventions. For CSP, UAE     followed by suction curettage appears to have more advantage than systemic MTX treatment and     may be a priority option.So some author suggests that curettage and systemic methotrexate     therapy and embolization as single treatments should be avoided if possible,combination of     them is more effective. Plenty of evidences suggested that UACE followed by suction curettage     under the guidance of ultrasonography or hysteroscopy is a priority choice.      However,in our clinical practices,suction curettage of CSP is more difficult than usual     induced abortion procedure of normal early pregnancy,because PCSD(previous cesarean scar     defect)is very common in CSP.In random populations the incidence of PCSD is present in     24%-69% of women evaluated with transvaginal sonography. Scar defects were seen in 61%     (66/108), 81% (35/43) and 100% (11/11) of the women who had undergone one, two and at least     three Cesarean sections by the transvaginal ultrasound examination.      What is the incidence of complications of suction curettage combined with UACE for CSP     treatment remains unknown.How to decrease the complications remains unknown too.So we     designed this study.   "
70949|NCT02357082|"     Registry intends to prospectively collect data regarding the safety of magnetic resonance     imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter     defibrillators.   "
70950|NCT02357069|"     This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate     the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in     subjects with active Rheumatoid Arthritis despite Methotrexate therapy.   "
71017|NCT02356198|"     This study is prospective, randomized trial in which EXPAREL TAP block is compared to     standard IT opioid administration, in relieving postoperative pain, decreasing length of     stay, and use of narcotic medication.   "
70951|NCT02357056|"     The purpose of this research is to objectively compare various training modalities currently     available in minimally invasive and robotic surgery to determine the most effective training     methods specific to robotic cardiac surgery. We hope to recruit medical trainees with minimal     robotic surgery training experience, randomly assigned to one of three groups (Dry wab, da     Vinci Simulator and Wet lab). Trainees will be evaluated at baseline for a standardized tasks     common in robotic cardiac surgery and then divided into one of the three training modalities.     Trainees will be given sufficient time to become proficient with a variety of predetermined     tasks unique to each training group. The trainees will then undergo a reevaluation with the     cardiac surgery specific tasks at the end of a standard training period. We will then be able     to compare our three groups to show if any have benefits over the others in regards to     improvement in technical ability, understanding of the robots functions, efficacy of     training, speed of technical skill development, accuracy and efficiency of movement. We will     rate each modality on their reproducibility, accuracy of representation, and ease of set up     and perform a cost analysis for each of the training methods.   "
70952|NCT02357043|"     The study aims to evaluate the accuracy of the blood glucose level results obtained from     fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to YSI as well as     to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons     using only device labeling.   "
70953|NCT02357030|"     The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available     medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy)     to treat Gulf War Illness (GWI).   "
70954|NCT02357017|"     The purpose of the study is to test the hypothesis that persistent fluid retention and high     sympathetic output contributes to the development of refractory hypertension (HTN). The     investigators will determine, in a cross-over assessment of high and low salt diets, if     dietary sodium restriction reduces 24-hr ambulatory BP in patients with refractory HTN.     Moreover, the investigators will determine if dietary sodium restriction lessens the severity     of obstructive sleep apnea (OSA) in patients with refractory HTN.   "
70955|NCT02357004|"     The purpose of this protocol is test whether patients with hypertension refractory to     antihypertensive treatment have evidence of excessive sympathetic (i.e., nervous system)     activity.   "
70956|NCT02356991|"     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and     Flt3. Phase I study has shown that the toxicity is manageable.      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in     patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC).   "
70957|NCT02356978|"     Evaluating the efficacity of a new device phototherapy by comparing it with conventional     phototherapy. Jaundice occurs in many newborns, and is, in most cases benign, However, owing     to the potential neurotoxicity of unconjugated bilirubin, newborns must be monitored to     identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin     encephalopathy or kernicterus. Treatment of jaundice in newborn relies on phototherapy,     exposing their skin to light of a specific wavelength . Fluorescent tubes or halogen lamps     have been used as light sources for phototherapy for many years. Light-emitting diodes (LEDs)     are more recent sources which are power efficient, have a longer life and are portable with     low heat production. Several technologies and devices are developed using LEDs and specially     a compact system.   "
70958|NCT02356965|"     The purpose of the study is to test two different doses of ketamine sub-lingual (under the     tongue) wafer against placebo to see how effective the medication is to treat moderate to     severe pain after wisdom tooth extraction.   "
70959|NCT02356952|"     Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin     associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and     other diseases, including some cancers. There has been an increased interest of researchers     in the relationship between MetS and diet and, specifically, Mediterranean diet would be     beneficial for people with high risk of developing MetS or individuals with established MetS.   "
70960|NCT02356939|"     Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the     patients is made when enlisted for LT. Definitive inclusion and randomization is performed     during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct     diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a     T-tube is placed into the bile duct, and removed endoscopically four to six months     postoperative. The surgical technique is available on a movie during randomization on the     website. The primary endpoint is the occurrence of biliary complications, including biliary     fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are     the incidence of complications related to the stent placement and its extraction by     endoscopy.      Discussion: Biliary complications following LT are significant causes of morbidity,     retransplantation and eventually mortality. Although controversial, the use of a T-tube has     been proven to be useless and even responsible for specific complications in many studies,     including several randomized trials. However, several studies have identified a small bile     duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be     significantly associated to biliary stenosis. Our team published a preliminary study     including 20 patients using a new technique of intraductal stenting. Only 4 complications     were reported in the overall study population while no biliary complication occurred in the     subgroup of patients who received a whole graft LT. Moreover, no technical failure and no     procedure-related complications were noted before and during drain removal. Although     intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a     multicentric randomized controlled study is needed to validate it as a protective tool for     biliary complications following LT.   "
70961|NCT02356926|"     Multicenter cluster randomized study to evaluate the reduction of the rate of severe medical     errors with implementation of systematic cross checkings between emergency physician.   "
70962|NCT02356913|"     The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess     bioequivalence between three new nicotine gum formulations and a reference nicotine gum in     healthy smokers.   "
70963|NCT02356900|"     This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric     environment for exercise performance at altitude. Subjects will complete a short,     high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after     this training phase, all subjects will be tested for maximum aerobic capacity at a simulated     high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of     mitochondrial oxidative capacity in a skeletal muscle biopsy.      A group of individuals of similar characteristics completing this training program in a     normoxic-normobaric environment will serve as a control.   "
71023|NCT02356120|"     The purpose of this study will be to evaluate the measurement of tricuspid annular plane     systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with     suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the     pulmonary arteries (CTPA)   "
70964|NCT02356887|"     During neurosurgical procedures, patients need to be placed in sitting position for surgical     access especially in surgeries in the vertex or posterior fossa. Due gravitational effect of     sitting position the flow in IJV may be reduced. Venous air embolism (VAE) is a common     complication of sitting position craniotomy and carries high mortality and morbidity. Venous     pressure decreases as the head of the patient is raised above the heart. Hence, negative     venous pressure in the cerebral venous system promotes entrapment of air in accidental     opening of the sinuses.      Common methods to prevent VAE in sitting position include increasing the venous pressure by     either jugular venous compression and/or increasing the venous pressure by adding positive     end expiratory pressure (PEEP). Both these methods can decrease venous return and can lead to     brain swelling.. In addition, improper neck position can cause the kinking of the IJV which     may lead to decreased venous drainage and increased ICP. This has been shown to be the     contributing factor for intraoperative brain swelling and postoperative neck and tongue     swelling leading to airway obstruction. Optimal brain perfusion is best in the neutral     position of the head, but surgery cannot always be performed with this.      Currently, there are no studies that looked into the IJV flow in sitting position and effect     of venous outflow obstruction on the IJV flow. Valsalva maneuver (forced inspiration with     closed glottis) and /or compression of internal jugular veins (IJV) are the two commonly used     physiological methods that can cause venous outflow obstruction. A custom made neck collar     can be used for compression of internal jugular vein and previous investigations have used a     similar device in a rat model to demonstrate the protective effects on slosh-mediated brain     injury by increasing intracranial blood volume . While the collars have not yet been studied     on people for their effectiveness at preventing concussions, many studies have looked at the     effect of neck collars on both jugular compression and ICP..      The purpose of this study is to measure the venous blood flow of healthy volunteers by the     use of an ultrasound and Doppler velocimetry in sitting position. the investigators will     measure the IJV flow on both sides in sitting position at rest and at two conditions of     venous outflow obstruction- 1. Neck compression using a custom made collar and 2. During 30     seconds Valsalva maneuver. This study will provide information on the cerebral venous     drainage. This information will be very useful in planning and positioning of patients     undergoing neurosurgical procedures and to prevent complications from the improper patient     position.   "
70965|NCT02356874|"     The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if     exercise can modify the disease course and prevent comorbidity in patient with     spondyloarthritis (SpA).   "
70966|NCT02356861|"     The purpose of this study is to learn if an experimental treatment can help thinking ability,     and memory in Veterans with mild or moderate traumatic brain injury (mTBI), and     post-traumatic stress disorder (PTSD). The experimental treatment is called transcranial,     light-emitting diode (LEDs) therapy,and uses groups of LEDs mounted inside a helmet. The     helmet is worn on the head, and the LEDs shine painless light on the sides, middle and front     of the head through the scalp. The participants receive a series of LED treatments which take     place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus. The LEDs     contain near-infrared diodes. The FDA considers the LED device used here, to be a     non-significant risk device. The LEDs do not produce heat.   "
70967|NCT02356848|"     This study will evaluate a comprehensive tailored behavioral intervention aimed to improve     foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent     ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy     for improving self-care and early detection of foot abnormalities in this at-risk population     using psychological theories to target multiple health behaviors simultaneously. This could     be an efficient and cost-effective approach to improve diabetes-related foot health behavior,     and other risk factors in patients who are vulnerable to devastating consequences related to     amputation.   "
70969|NCT02356822|"     This is an investigational multi-site outcomes registry intended to collect information about     a patient's cancer care. Patients may enter the Registry at any time during the patient's     current stage in the continuum of care. The registries main objectives will be to measure and     evaluate the effects of patient care throughout the care continuum, resulting in the     identification of the most effective treatment options. Objectives will encompass evaluations     and analytics around safety, effectiveness, and improved efficiencies.   "
70970|NCT02356809|"     The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in     the treatment of digital ulcers related to secondary Raynaud's phenomenon associated with     systemic scleroderma   "
70971|NCT02356796|"     The purpose of this study is to evaluate the effect of a multidisciplinary group based     treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The     hypothesis is that multidisciplinary group based treatment is more effective than standard     physiotherapy for women with CPP. The participants will be randomized to one of two treatment     arms, and the treatment effect will be evaluated 12 months after start of intervention.   "
70972|NCT02356783|"     Our aim is to assess usability and compliance of a wireless pedometer for monitoring step     count after a lumbar epidural steroid injection for the treatment of radicular pain in low     back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can     be used to measure efficacy of pain interventions.   "
70973|NCT02356770|"     The objective of this study is to investigate the safety and the function of the collagen     Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of     the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue     augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and     III.      Study patients must have a single tooth gap with insufficient soft tissue volume after     implant placement. Therefore a soft tissue augmentation will be necessary.   "
70974|NCT02356757|"     The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve     foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose,     blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher     than normal risk for amputation. This novel intervention aims to improve self-care and early     detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care     using advanced behavioral approaches to target adherence to multiple health behaviors,     including foot self-care, self-monitoring, medication adherence, dietary adherence, and     physical activity simultaneously. If this promising behavioral theory-driven approach     delivered using common technology (phone) to the patient at home can work in a setting where     improvements in foot care are so urgent, it will be an important scientific contribution.   "
70975|NCT02356744|"     Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and     after 1 year of surgery.   "
70976|NCT02356731|"     Epilepsy is one of the most common neurological diseases.Approximately 53 million people     suffering from chronic recurrent epilepsy in 1990 and that number increased about 58 million     in 2005.      The annual incidence of epilepsy varies considerably in different epidemiological studies,     ranging from 11 cases per 100,000 general population to 230 cases per 100,000 people.      To date there has been discovered the ideal Antiepileptic Drugs. The drug, ie, that are safe     and effective, it has good daily administration frequency, easily administered from all     roads, which has high bioavailability, which is not highly bound to proteins, and not holding     inductive or inhibitory effect.   "
70978|NCT02356705|"     Midazolam is often given before surgery to sedate a patient before anesthesia is given.     Children are often given a small dose either by mouth or squirted into the nose. Children     will often spit out the oral midazolam, making it difficult to know how much medicine, if     any, they have received. Giving midazolam into the nose is more reliable, but children may     complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also     occur when midazolam is squirted alone into the nose. The purpose of this study is to see if     adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam     easier and more comfortable without affecting how the midazolam works as a sedative. This is     follow up to the pilot study, Project # 994. This will expand the previous study, with     additional participants and revised xylocaine concentration   "
70979|NCT02356692|"     The purpose of this study was to investigate the overall clinical comfort performance of     enfilcon A and senofilcon A lenses over 15-minutes of lens wear.   "
70980|NCT02356679|"     The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in     Gastritis Patients.   "
70981|NCT02356666|"     Different definitions of nocturnal hypoventilation are used in the recent literature. The     investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular     disease's population according to different definitions issued from the literature.   "
70982|NCT02356653|"     The goal of this protocol is to expand access for patients who lack a fully HLA (Human     leukocyte antigen) matched sibling donor and who are candidates for allogeneic hematopoietic     stem cell transplant (HSCT). These patients have a serious or immediately life-threatening     disease for which HSCT is indicated. These patients are not eligible for other Children's     Hospital of Philadelphia IRB approved protocols that utilize CliniMACs technology for T     depletion.   "
71008|NCT02356315|"     New advances in medical imaging have allowed for the measurement of brain activity related to     chronic pain. In addition to the brain, the investigators aim to use functional magnetic     resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy     subjects and chronic neck pain patients. The information gained from this study will increase     the investigators understanding of how chronic pain is encoded in the nervous system and     assist in developing more effective treatment strategies.   "
71009|NCT02356302|"     Research is currently underway to develop new HIV prevention strategies. Intravaginal rings     (IVRs) are one drug delivery method that is currently being studied. This study will evaluate     the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a combination of     vicriviroc/MK-2048, in healthy, HIV-uninfected women.   "
70983|NCT02356640|"     Patients suffering from pancreatic cancer are associated with a poor prognosis and survival     of less than one year is expected in inoperable tumours. Management of these patients would     be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this     intractable pain is often difficult to treat. Different pharmacological agents have been     used in the past to control this pain and these include non-steroidal anti-inflammatory drugs     and narcotic agents. However, patients' responses are often variable and difficult to     predict. Furthermore, these agents are associated with their own adverse effects and may     further impair quality of life.      Celiac plexus neurolysis (CPN) was first described in 1919, since then, different approaches     of performing the procedure have been described. The standard technique involves a     percutaneous approach but CPN can also be performed by an intra-operative approach with open     or laparoscopic means. Results from meta-analysis have shown that CPN was associated with     superior pain relief as compared to analgesic therapy alone and reduces the need for opioids     analgesics in patients with inoperable pancreatic cancer. Furthermore, CPN causes fewer     adverse effects than opioid analgesics and it is the preferred method of improving pain     relief in these patients.      Recently, endoscopic ultrasonography (EUS) - guided CPN has become popular. The approach is     safe and effective and was shown to be associated with long lasting pain relieve in patients     suffering from chronic pancreatitis or pancreatic cancer. Serious complications are uncommon     and are less than 2% in these series. Transient diarrhoea and hypotension are common after     CPN and is seen up to 30% to 40% of the patients, regardless of whether the procedure is     being done by the EUS or percutaneous approach. The EUS approach offers several theoretical     advantages over the percutaneous option. Most notably is the visualization of the celiac     ganglia situated anterior to the aorta, allowing direct injection of the ganglia with alcohol     resulting in celiac ganglion neurolysis (CGN). This increases the accuracy of CPN and may     result in improved pain control. Furthermore, it could reduce complications associated with     the percutaneous approach that includes lower extremity paresthesia and paralysis.      Hence, the aim of the study is to compare the efficacy and safety of endoscopic ultrasound     (EUS)-guided celiac ganglion neurolysis (CGN) versus percutaneous celiac plexus neurolysis     (CPN) in reducing cancer pain in patients suffering from inoperable cancer. With direct     visualization and injection of the celiac ganglion, the investigators hypothesis that     EUS-guided CGN is more advantageous on improving pain relief and decreasing the need for     opioid analgesics in patients with inoperable cancer as compared to percutaneous CPN.   "
70984|NCT02356627|"     The purpose of this study is to examine the effectiveness and cost-effectiveness of the     Cancer Home Life Intervention compared to usual care on performance of and participation in     everyday activities and quality of life in people with advanced cancer living at home.   "
70985|NCT02356614|"     This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study     to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese     population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up to     10 years after implantation.   "
70986|NCT02356601|"     Ultrasound is used increasingly to aid placement of neuraxial blocks. Good visibility of     ligamentum duramater complex and posterior longitudinal ligament (LF, PLL) has a positive     predictive value of 85% for successful neuraxial block. Dural puncture could still be     feasible despite the absence of a good view, as reflected by a negative predictive value of     30%.      Poor neuraxial ultrasound view could be due to limitations of ultrasound or various other     anatomical reasons which might include absent LF, calciﬁcation of ligaments, spinous process     contact and presence or absence of epidural or subdural fat. This will be the first study of     its kind to compare neuraxial ultrasound with MRI. The aim of this study is to look for     anatomical correlation between neuraxial ultrasound and MRI at various lumbar interspinous     levels and to look at factors that contribute to abnormal neuraxial imaging. Assuming the     predicted abnormal ultrasound images to be around 30% and predicted abnormal MRI images to be     5%, 79 images should give a power of 0.9 and alpha 0.01 to analyse the association between     the two. Sample Size Calculations were performed using statistical software R version 2.15.2   "
70987|NCT02356588|"     The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil     Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of     moderate-to-severe acute post-operative pain in patients after abdominal surgery.   "
71049|NCT02355782|"     The purpose of this compassionate use study, for two patients with thrombotic     microangiopathy, is to provide expanded access to patients who have participated in the     clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed     while on treatment or to patients who could otherwise benefit from the treatment. This is a     treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001     deemed eligible by the investigator may participate.   "
70988|NCT02356575|"     The aim of this study is to determine which of two treatments (acupuncture or cognitive     behavioral therapy) works better for treating insomnia in cancer survivors. The investigator     also wants to study the factors that might impact why someone might prefer or do better in     one treatment over the other.      Group 1 will get Acupuncture - Acupuncture is an ancient Chinese Technique of using very thin     needles inserted in the skin to treat different symptoms and illness, and to promote healing.      Group 2 will get Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT-I is a treatment to     address behaviors and thoughts that are known to effect problems with sleep.   "
70989|NCT02356562|"     The purpose of this study is to evaluate the safety and efficacy of ombitasvir/ABT-450/r and     dasabuvir with or without Sofosbuvir and RBV in DAA treatment-experienced adults with     Genotype 1 Chronic Hepatitis C Virus infection.   "
70990|NCT02356549|"     The purpose of this study is to determine if the use of tailored health messages and/or     involving physicians are effective in increasing African American (AA) patient activation in     a clinical trial consultation. The proposal will use a composite score for patient activation     derived from the Street Patient Activation Coding system. This will help to determine the     effectiveness of our intervention on patient activation and patient centered clinical trial     decision.   "
70991|NCT02356536|"     The CuePeD trial is an intervention trial measuring the effectiveness of a novel treatment     for Freezing of Gait (FOG) in Parkinson's disease (PD). The primary intervention is the use     of a wearable cueing device (WCD), which detects and responds to FOG and extinguishes on the     resumption of normal walking. It is designed for use in PD patients with FOG, in their home     environment where FOG is most severe. Kinematic data will be logged by a memory card in the     belt worn device recording FOG, and falls. The device will be used on 3 different settings in     a gait laboratory environment, and then for 2 weeks in the patient's own home using the same     3 settings. A battery of psychometric instruments will be administered before and after the     trial   "
70992|NCT02356523|"     The Purpose of this study is to evaluate the incidence of delirium in Cardiac Intensive Care     Unit Patients.   "
70993|NCT02356510|"     The current guidelines still recommend emergent PCI of the culprit lesion and state that     primary PCI should be limited to the culprit vessel with the exception of cardiogenic shock     and persistent ischaemia after PCI of the supposed culprit lesion. This recommendation is     based on a high number of studies. However, several studies are present about the safety and     efficacy of non-culprit vessel PCI during acute MI. Nowadays, the debate is increasingly     going on about the PCI of the non-culprit arteries during the index event with newer     prospective randomized studies. Besides, it is still unclear for the culprit artery whether     to treat only the culprit lesion or all the other lesions in the culprit vessel during the     index event. The present report describes a retrospective comparison between the two     strategies during primary PCI for STEMI, looking for their influence on the clinical and     angiographic course of the patients.   "
70994|NCT02356497|"     Bone metastases are frequent distant manifestations of cancer, with pain as a common and     devastating consequence. The primary treatment for painful bone metastases, external beam     radiation therapy, is moderately effective: about 60% of patients who undergo conventional     radiotherapy experience (partial) pain relief. Several factors associated with treatment     failure have been identified, but no attempts have been made to collapse these factors into a     clinically useful prediction tool to predict treatment response. In addition, to aid in     therapy selection based on expected survival time, development of survival models is     essential. Finally, we need innovative treatments as alternatives or additive to standard     treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT     cohort study, recruiting patients at the departments of radiation oncology and orthopedic     surgery.      We aim to provide detailed information about clinical data, create an infrastructure for     efficient, fast and pragmatic evaluation and implementation of innovative interventions, as     well as development of accurate new prediction tools.   "
70995|NCT02356484|"     The aim of this study is to evaluate the predictive value of albumine, C-reactive protein     (CRP), procalcitonin, and lactates in terms of surgical stress and postoperative     complications. These biomarkers will be measured from the day before surgery until     postoperative day four in patients undergoing major surgery. Major surgery was defined as     esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures     including an organ resection for benign or malignant disease and lasting more than 2 hours.   "
70996|NCT02356471|"     This pilot clinical trial studies how well consumer-based activity monitor works in     evaluating and measuring activity of older patients with abdominal cancer undergoing surgery.     Consumer-based activity monitor (CAM) may identify patients who are at-risk for increased     post-surgery medical problems. With early identification of at-risk patients, CAM provide     supervised exercise in the preoperative and postoperative periods to improve over mobility     and potentially decrease preoperative complications among patients undergoing major abdominal     surgery.   "
70997|NCT02356458|"     Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no     standard therapeutic options in case of relapse. Prolongation of remissions or induction of     longer remissions is therefore crucial. Recently, a synergistic increase in the proteasomal     inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown.     These findings, along with the reported single agent activities of both drugs and the     non-overlapping toxicities, are the rationale to combine ibrutinib and bortezomib in MCL in     this trial   "
70998|NCT02356445|"     Retrospective review of the outcome of use of immunosuppressive drugs in treatment of     sarcoidosis   "
71024|NCT02356107|"     The investigators hypothesize that the administration of two widely available, naturally     occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the     severity of depression in individuals exposed to chronic hypoxia by living at altitude. The     purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g     creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms     measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or     SNRI-resistant depression.   "
71025|NCT02356094|"     Characterization of posterior corneal changes in primary open angle glaucoma patients, using     Scheimpflug examination.   "
70999|NCT02356432|"     Anticoagulants are generally recognized as a necessary therapy to prevent the recurrence of     ischemic stroke in patients with non-valvular atrial fibrillation (NVAF), but in some     patients they also cause bleedings, particularly intracranial hemorrhage. One of the     independent predictors of intracerebral hemorrhage is the presence of cerebral microbleeds     (CMBs); a high incidence of intracerebral hemorrhage is reported in patients with multiple     CMBs. Recent study suggested that patients who had CMBs at baseline developed more new CMBs     after 2 years (26%), compared with patients (12%) who did not have CMBs at baseline. However,     there has been no study on the progression of CMBs in patients receiving so-called novel oral     anticoagulants (NOACs).      This study tests the hypothesis that the incidence of hemorrhagic stroke is lower in patients     receiving NOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) than in those receiving     warfarin, and this difference reflects the difference in the effects of warfarin and NOACs on     the progression of CMBs. Towards this goal, we enroll 200 patients with at least one CMB     detected by 1.5 T MRI (T2*WI) at baseline, who treated with NOACs or warfarin for 12 months.     Primary endpoint is the proportion of subjects with an increased number of CMBs at Month 12     of treatment with NOACs or warfarin. If the results of this study support the efficacy of     NOACs in preventing increase of CMBs, this would be of great interest to domestic and     overseas clinicians, in view of the potential therapeutic impact, including that for primary     prevention of ischemic stroke.   "
71000|NCT02356419|"     The study is a single center and open test, and the dose of successive incremental method was     taken. In order to determine the tolerance and safety after a single intravenous injection of     different doses of rESP in healthy subjects, the investigators had this trial. On the other     hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.   "
71001|NCT02356406|"     This prospective study evaluates celiac plexus radiosurgery for pain control in patients with     upper abdominal malignancies.   "
71002|NCT02356393|"     Association between serum magnesium and clinical outcome in patients with acute MI (AMI) with     1 year follow-up in 300 patients in regions supplied by desalinated drinking water (DSW)     (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW) (Nahariya     MC).   "
71003|NCT02356380|"     To determine the affects of Physical Therapists clinical reasoning using thoracic spine     mobilization for neck pain compared to a standard protocol.   "
71004|NCT02356367|"     The purpose of this study is to determine the predictive factors of poor compliance to sleep     disordered breathing therapy in chronic heart failure patients treated for central sleep     apnea. To characterize nocturia pathophysiology associated with SDB in this population. To     use telemonitoring data to define predictive factors of poor compliance.   "
71005|NCT02356354|"     The aim of this study is to understand why the regeneration of the cutaneous sensory nerve     fibers is poor in post-burn scar.      The presence or the lack of several molecular factors known to regulate neuronal cell     development will be evaluate and compared within biopsies from healthy skin and post-burn     scar.   "
71006|NCT02356341|"     This observational study is intended to collect outcome data from a cohort of 90 patients     suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated     with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.   "
71007|NCT02356328|"     This observational study is intended to collect outcome data from a cohort of 30 patients     suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are     treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks.   "
77364|NCT02273219|"     Primary objective is to define the maximum tolerated dose (MTD) for the combination of AEB071     and BYL719. Secondary objectives are to define the safety and tolerability of AEB071 and     BYL719.   "
71012|NCT02356263|"     Stressors impair optimum function of an individual physiologically and psychologically.     Overcoming stress is possible when one knows which aspects of life are the most troublesome     to manage for individuals. There are certain tools available in Pakistan that can measures     stress in selected populations but there are no validated tools that may quantify stress     which results from events occurring in different aspects of life.      Recent Life Changes Questionnaire (RLCQ) is a tool that measures stress of individuals     through life changing events. It has five categories; work, home and family, health, personal     and social and financial. The objective of the study is to adapt RLCQ and validate it so that     it may measure stress among people living in Karachi, Pakistan.   "
71013|NCT02356250|"     Rationale for the study:      To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation     between HVPG result and PEF result in a way that the result of the PEF test will be able to     predict if a patient has CSPH (yes of no). By this, to try and develop a portable     office-based device that can produce immediate results in a non-invasive manner in cirrhotic     patients and help in evaluating prognosis in these patients in a noninvasive manner.      Aim:      The aim of this study is to try and characterize the peripheral endothelial function (PEF) in     patient with cirrhosis and CSPH. This will be evaluated by measuring the PEF in every patient     before evaluating his HVPG level in a hemodynamic study.   "
71014|NCT02356237|"     This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal     outcomes. Half of the participants will undergo selective episiotomy (according to routine     delivery management at the particular hospital), while the other half will not undergo     epitiotomy at all.      Our hypothesis is that no differences in maternal and neonatal outcomes will be demonstrated     between these two groups.   "
71015|NCT02356224|"     SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an     insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose     study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in     healthy subjects.   "
71016|NCT02356211|"     Objective To reduce subsequent falls following Multifactorial Falls Assessment Design:     Prospective Case Control      Population: Frail elderly Veteran outpatient population referred for falls assessment      Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic     patients followed for 1 year and outcomes compared to Falls e-Consult Clinic (chart review)     and Acute Geriatric Evaluation and Management (GEM) Inpatient Unit discharge control groups.   "
71018|NCT02356185|"     Background:      Data are scarce concerning injecting drug use (IDU) and alcohol consumption among     HIV-infected people on highly active antiretroviral treatment (HAART) in Cameroon. The aim of     this study is to determine the prevalence of alcohol consumption and IDU among HIV-infected     people on HAART; to determine sociodemographic factors associated with alcohol abuse and IDU     among people on HAART; and to determine impact of alcohol consumption and IDU on adherence to     HAART.      Methods/Design:      The investigators will conduct a cross sectional study at the Yaoundé Central Hospital in     Cameroon, from February to August 2015. Using a self-report questionnaire, the investigators     will include at least 1,000 HIV-infected adults (18 years or more) on HAART for at least one     month coming for HIV care. The investigators will exclude pregnant women. Data collection     will include sociodemographic and economic profile, alcohol consumption using Alcohol Use     Disorders Identification Test, injecting drug use, adherence to HAART using visual analog     scale and self-rate report. The investigators will perform sub-analysis for sex group and     area of habitation. A p value < 0.05 will be considered statistically significant.      Discussion:      There is a critical need of accurate estimates of the amplitude and the distribution of IDU     and alcohol consumption among HIV-infected adults, in order to inform health policies maker     for curbing burden of both injecting drug use and alcohol consumption among people living     with HIV.   "
71019|NCT02356172|"     Background:      - Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go     through puberty late. Some never reach puberty or don t complete it without treatment. They     also may have an impaired sense of smell or other health problems. Research shows that     disorders like this can have a negative effect on a person s psychological profile.      Objective:      - To understand the psychological outcomes in people with IGD. These can include depression,     anxiety, poor health, and poor social function.      Eligibility:        -  Adults age 18 and over with IGD. They must be currently on a full dose of hormone          replacement therapy for at least 3 months.        -  Healthy adult volunteers.      Design:        -  Participants will get a username and password. This will give them access to questions          online. They can do this from any computer connected to the Internet.        -  Participants will log in and complete the questionnaires. There are 5 total, but they          will appear as 1 continuous set of questions. Answering them takes about 1 hour or less.        -  The first set is about the participant s disorder. The rest ask about depression,          anxiety, global health, and social function.        -  All answers will be used for research and to better understand reproductive disorders.          Only researchers from the NIH Unit on Genetics of Puberty and Reproduction and from this          study will know which answers belong to which participant.   "
71041|NCT02355886|"     This randomized phase II/III trial studies gabapentin in reducing the need for pain     medication in patients with bladder cancer undergoing surgery to remove the bladder and     nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after     surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.   "
71054|NCT02355717|"     The proposed research brings together complementary expertise to systematically elucidate the     longitudinal effects of (1) total and regional body fat and (2) the metabolic impairment that     accompanies obesity on bone development during growth. The contribution of this research will     be significant because it will provide a solid foundation for understanding the influence of     fat (total and regional distribution) on overall bone strength, and whether insulin     resistance, beta-cell dysfunction, abnormal lipids, and inflammation could be underpinning     factors in the fat-bone strength relationship via effects on bone modeling activity. This     knowledge will provide critical information needed to maximize potential therapeutic     interventions to counter the linked risks of obesity and osteoporosis, both major public     health concerns.   "
71020|NCT02356159|"     Background:      - In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given     to a recipient. Sometimes the recipient s immune system destroys the donor s cells. Or donor     immune cells attack the recipient s tissues, called graft-versus-host disease (GVHD). This is     less likely when the recipient and donor have similar human leukocyte antigens (HLA).     Researchers want to see if the drug palifermin improves the results of allogeneic SCT from     HLA-matched unrelated donors.      Objective:      - To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and     improve immune function after transplant.      Eligibility:      - Adults 18 70 with blood or bone marrow cancer with no HLA-matched sibling, but with a     possible HLA-matched donor.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests. They will have scans and heart and lung exams.        -  Before transplant, participants will:        -  Have many tests and exams. These include blood tests throughout the study and bone          marrow biopsy.        -  Get a central line catheter if they do not have one.        -  Have 1 3 rounds of chemotherapy.        -  Take more tests to make sure they can have the transplant, including medical history,          physical exam, and CT scan.        -  Get palifermin by IV and more chemotherapy. They will get other drugs, some they will          take for 6 months.        -  Participants will get the SCT.        -  After transplant, participants will:        -  Be hospitalized at least 3 4 weeks.        -  Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and          biopsies.        -  Stay near D.C. for 3 months.        -  Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.   "
71021|NCT02356146|"     Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained     by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients     receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5     expression and tacrolimus dosage using tacrolimus concentration after single dose     administration prior to kidney transplantation.      Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of     tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients     with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression     were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage     which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were     recorded.      The genotyping, TacC12, and target tacrolimus dosage have good correlations.   "
71022|NCT02356133|"     record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ     disfunction and the outcome of patients after operation by Near-Infrared Spectroscopy in     Endovascular Neurosurgery   "
71026|NCT02356081|"     Chemotherapy may cause distressing symptoms which can impact on patients' quality of life.     Chemotherapy is frequently given on an outpatient basis therefore patients are often required     to manage the symptoms they experience at home without direct supervision from healthcare     professionals. This study aims to evaluate the impact of a mobile phone based, remote     monitoring, symptom management system (ASyMS) on the delivery of care to people with     nonmetastatic breast, colorectal or haematological cancer during chemotherapy and for one     year following treatment. The study aims to compare a number of outcomes of patients using     the ASyMS intervention with outcomes of patients who receive normal care at their hospital.     Throughout chemotherapy treatment, once a day and any other time they feel unwell, patients     allocated to the mobile phone group will enter information on the phone regarding any     symptoms they are experiencing, take their temperature and enter this on the phone. The     information is sent via secure connection to a computer, which assesses the information and     sends an alert to their health care professional in the hospital, who will call the patient     at home if the patient has reported problematic symptoms. Patients in the normal care group     will receive care as normal at their hospital. Both groups of patients will be asked to     complete a series of questionnaires before they start treatment, after each chemotherapy     cycle and at 3, 6, 9, 12 months after treatment completion (a subset of patients will also be     asked to complete midcycle symptom assessments). The study will also evaluate the cost     benefit of ASyMS, assess changes in clinical practice as a result of ASyMS and develop a     predictive risk model (statistical model) for use in future care of patients receiving     chemotherapy for these cancers. This multicentre study is taking place across a number of     European countries.   "
71027|NCT02356068|"     Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests     (INR, platelets count) can not predict bleeding or blood product requirements during liver     transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole     blood coagulation generation and lysis. TEM results are available more rapidly than     conventional tests and give additional information regarding coagulation strengh, platelet     function, and fibrinolysis.   "
71028|NCT02356055|"     People with Alzheimer's disease and related dementias present with changes in how they think,     move and emotionally respond to daily life situations. While type of dementia will dictate     how severe certain symptoms are, all people with dementia will report a gradual change in how     they function in daily life skills. Losing the ability to do daily life tasks, such as using     a cell phone, balance a checkbook or get dressed in the morning signifies loss for both the     person with dementia and their caregiver. Caregivers that assist with daily life tasks report     more depression and anxiety, as well as a higher burden of care. People with dementia that     lose the ability to perform daily tasks report more depression and decreased satisfaction     with life. Despite gains in research, researchers are still missing important pieces that     will improve rehabilitation interventions for improving daily life skills.      In order to address the needs of people with dementia, an intervention called Skill-building     through Task-Oriented Motor Practice (STOMP) was developed by an occupational therapist. Our     team proposes that improvement in daily life skills is possible under certain circumstances.     First, the daily life task a person is addressing in rehabilitation should be     personally-meaningful and should also be the task practiced in therapy which is called     task-oriented training. For example, a person that is having trouble making a sandwich     should practice making a sandwich. Second, the investigators propose that people with     dementia need a lot of correct practice so that the brain has time to rewire how to do     the task correctly. Therefore, when patients practice tasks using STOMP, investigators do not     allow our participants to make errors and patients practice for long periods of time.     Investigators also incorporate and provide new technology into training such as medication     reminder alarms and photo phones which allow you to dial a number by choosing a loved one's     picture.      In this pilot study, the investigators want to look more closely at the how the amount of     time you practice influences study outcomes. The investigators believe that the findings from     this study will support our belief that more time in therapy is needed to enhance how someone     with dementia learns.   "
71030|NCT02356029|"     The primary objective of this study is to determine how often cardiopulmonary resuscitation     (CPR) is perceived as inappropriate by Healthcare Providers (HCPs) working in prehospital     Ambulance Services and Emergency Departments. Perception of inappropriate CPR is defined as     resuscitation efforts perceived by HCPs as disproportionate to the expected prognosis of the     patient in terms of survival or quality of life.      When a HCP perceives CPR as inappropriate, this may cause moral and emotional distress. This     perception may be modulated by the personal background and professional role of the HCP, but     also by his/her working conditions. Apart from the workload, the resulting distress can be     influenced by the way non-technical skills are developed within the team and the ethical     environment in which the HCP functions. Frequent exposure to similar patient care situations     and/or a professional environment not acknowledging the distress may lead to deficient coping     mechanisms and accumulation of moral distress. This may be associated with job leave, burnout     and a decreased quality of patient care. Acute distress may also influence the quality of     care provided to actual and future patients.      Secondary objectives of the study are to evaluate whether perceived inappropriateness of CPR     is not only associated with patient related factors but also with personal characteristics     and work related factors. Potential consequences for HCP's like moral distress and     intentional job leave will be assessed.   "
71031|NCT02356016|"     The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS)     and/or nutritional on body composition and functional tasks in elderly females with     sarcopenic obesity. Seventy-five, non-sportive, independently living women 70 years and older     with Sarcopenic Obesity were randomly assigned to either a WB-EMS group ( n=25), a     WB-EMS/nutritional supplements (n=25) or a semi-active control group (an=25). The WB-EMS     protocol applied one session of 18 min/week of WB-EMS (bipolar, 85 Hz). Nutritional strategy     based on a high protein supplement.   "
71032|NCT02356003|"     Tics are the core symptom of Tourette syndrome. These are repetitive, sudden, semi-voluntary     movements or sounds. In some children, these tics can be especially bad and require     treatment, however, options are limited. It is only with time and practice that youth with     Tourette syndrome are better able to suppress their tics. For these reasons, new     interventions are needed. The investigators will target a brain region involved in tics     called the supplementary motor area. Using low frequency repetitive transcranial magnetic     stimulation, the investigators will inhibit the activity, in a similar way to the tic     suppression that develops with age. The investigators propose the following objectives: (Aim     1) The investigators hypothesize that Tourette syndrome symptom severity (as measured by the     Yale Global Tic severity Scale) will decrease with low frequency repetitive transcranial     magnetic stimulation targeting the supplementary motor area. (Aim 2) The investigators     further hypothesize that improvement in Tourette syndrome symptoms will be moderated by low     frequency repetitive transcranial magnetic stimulation induced changes in GABA and glutamate     in the supplementary motor area, and changes in the functional connectivity between the     supplementary motor area and primary motor cortex. Eleven children (7-12 years of age) with     Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation     (five times a week for three weeks). After the three weeks, they will look for changes in tic     severity and brain chemistry and function. By developing a novel avenue for treating Tourette     syndrome, they can directly impact the care of children by reducing the severity of tics and     improving quality of life.   "
71033|NCT02355990|"     The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy     (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.   "
71036|NCT02355951|"     Objectives:      Primary Objective:      To identify and preselect patients with chronic HBV mono infection, who are undetectable for     anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02     Phase1/1b First in Man (FIM) study.      Secondary Objectives:      To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.      Methodology:      Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides     for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single     peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a     central laboratory using a newly validated assay.   "
71037|NCT02355938|"     The primary purpose of this study is to compare the clinical outcomes of cure and recurrence     of Clostridium difficile infection in spinal cord injured patients who are treated with oral     Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall     costs of treatment of Clostridium difficile infection in the two study groups.   "
71038|NCT02355925|"     The present study is designed as a pilot study with 150 patients in each group. Data     collection form will be filled by the researcher who does not know the type of intervention     in each group. Data analysis will be done through descriptive and perceptive statistical     methods by using SPSS software version 20 for windows   "
71039|NCT02355912|"     The purpose of this study is for transfemoral amputees to walk with an experimental robotic     prosthesis. Electric signals will be measured from their muscles and used to help control an     artificial leg. The investigators will record from sensors placed on a prosthesis and     electric signals measured from muscles in the participants leg to see if the investigators     can develop better computer programs to help predict subject actions and prostheses function.   "
71040|NCT02355899|"     This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in     patients with distal subungual onychomycosis of the great toenail. Patients will receive four     PDT treatments with PD P 506 A in weekly intervals.   "
71083|NCT02355340|"     This research study is evaluating bone mineral density in childhood cancer survivors who have     a history of bone fracture.   "
71042|NCT02355873|"     CRRT patients are generally critical ill patients with unstable conditions, such as low blood     pressure,severe SIRS,et al. Acute kidney injury(AKI)is especially prevalent,with even two or     more organ failure. CRRT serves as an important supportive therapy.Continuous anticoagulation     is needed to prevent treatment interruptions due to clotting of the extracorporeal circuit.     Unfractionated heparin or low molecular weight heparin both increase the risk of bleeding and     heparin induced thrombocytopenia in such cases.However, the problem of CRRT without     anticoagulation is the early filter clotting. An alternative method is the use of heparin     coated hemofilter. The AN69 ST hemofilter, a surface-treated polyacrylonitrile membrane     hemofilter, allows irreversible fixing of heparin to filter membrane, is able to reduce     thrombogenic properties of the membrane. In this study, we observe the efficacy and safety of     heparin-coated AN69 ST hemofilter in CRRT patients, and compare to the original AN69 membrane     hemofilter.   "
71043|NCT02355860|"     In an urban gynecology practice serving patients with publicly and privately funded     insurance, female sexual dysfunction was associated with low income, depression, urinary     incontinence, and sexual inactivity.   "
71044|NCT02355847|"     Additional educational training lectures were provided to healthcare workers. Outcome measure     of cultural competency was completed to assess patient safety, risk management, and cultural     competency of healthcare providers in an urban academic Labor and Delivery Unit.   "
71045|NCT02355834|"     Inflammatory Bowel Disease (IBD) affects 250,000 adults in the United Kingdom (UK) and causes     bouts of diarrhoea which are hard to control. Over a quarter of patients experience extremely     distressing faecal incontinence (FI). Even when the disease is in remission, the majority of     patients live in fear of not finding a toilet in time. This curtails their activities and     quality of life. The National Institute for Clinical Excellence (NICE 2007) has issued     national guidance on actively asking patients about FI and a step-wise care plan for managing     FI. However, this has not been evaluated in people with IBD, the vast majority of whom do not     ask for help, even when they have frequent FI.      Across six expert centres in the UK, the investigators will perform 3 linked studies: [1] The     investigators will screen people with IBD, offering the opportunity to obtain help with bowel     control. The investigators will compare uptake of a postal approach versus response to a     proactive face-to-face asking approach at a physical or telephone clinical appointment. [2]     The investigators will conduct a randomised controlled trial (RCT) comparing two different     approaches (IBD nurse specialist plus self-help booklet versus self-help booklet alone) to     see which one produces the best results in terms of reductions in FI, other symptoms, costs     and quality of life at 6 months after intervention. Booklet group participants may access the     nurse intervention at 6 months if they wish, when the RCT is finished. [3] Interviews will be     performed at the end of the intervention, gathering patient views and preferences and staff     perspectives via Qualitative interviews and free text questionnaire comments, to enable a     rich understanding and interpretation of our results.      The investigators will disseminate the results widely to people with IBD and health     professionals and take active steps to embed successful interventions in NHS services, having     gained sound evidence on how many people want help, whether intervention is effective in     improving FI, and patient and staff views on interventions.   "
71046|NCT02355821|"     This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1     C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.   "
71047|NCT02355808|"     Lack of internet infrastructure, personal skills, and service provision have been identified     as potential barriers to e-health but as yet there is no good evidence of the impact of     interventions to improve them. This study aims to assess impact on e-health uptake of three     interventions (i) superfast broadband, (ii) a tailored leaflet to help participants improve     personal internet skills and support, (iii) GP interventions to improve health service     provision of e-health. In a cluster randomised factorial controlled trial, 1388 households     from 78 postcodes were randomly selected from the 20088 Cornish postcodes and allocated to     the 8 (2X2X2) arms of the study. Comparison of 'e-health readiness' and 'miles travelled'     from baseline to 18 month follow-up between the 8 arms of the study, will be used to assess     the effects of interventions, singly and in combination.   "
71048|NCT02355795|"     The aim of the current study is to evaluate the effects of diets with three levels of dietary     fat on weight change and related cardiometabolic risk factors in a 6-month randomized     controlled-feeding trial.   "
71079|NCT02355392|"     The purpose of this study is to determine the prevalence of hypertension among citizens of     Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the     insufficiently treated, and to estimate the prevalence of white coat and masked hypertension     using home blood pressure measurements with telemedical data transmission.   "
71050|NCT02355769|"     Preventing heart failure (HF) deterioration is a great challenge for contemporary medicine.     The progress course of HF is with increasing frequency of subsequent hospitalizations     (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs     of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. The     difficulty in treatment of patients with HF deterioration is associated with numerous     comorbidities and coexisting complications (i.e. aggravation of ischaemic heart disease, lung     diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations,     in particular emergency ones). Our study is aimed to evaluation the complex     pathophysiological background related to heart failure deterioration with respect to the     effect of applied in-hospital treatment.   "
71051|NCT02355756|"     This will be a single center, open-label study in healthy male subjects between 18 and 45     years old to determine the dose response profiles of dermal blood flow in response to     intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time     finding and Part II: reproducibility over time.   "
71052|NCT02355743|"     The primary research question is, in patients with short bowel syndrome requiring central     venous access device (CVAD) for long-term total parenteral nutrition, is once weekly     recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care     using heparin flushes in reducing the incidence of line-associated thrombosis and infection.   "
71053|NCT02355730|"     This study is to further develop and optimise the design and manufacturing process of a     handheld device to monitor and manage Warfarin (blood thinning anticoagulation drug) therapy.     The device comprises of a handheld instrument and a disposable test strip and reports how     blood coagulation is working in terms of standardised units called International Normalised     Ratio (INR). A single drop of fresh whole blood and plasma will be added to the strip and the     INR result displayed on the instrument. Blood samples are to be collected from patients     attending a hospital based INR clinic who are on Warfarin Therapy. The samples are to be used     in a series of experiments in the laboratory to test the Microvisk POC INR Monitors accuracy,     precision, stability and robustness.   "
71055|NCT02355704|"     Renal Insufficiency is a priority disease in health system, which may require renal     replacement therapy based on renal transplantation, which is considered as therapy of choice.     During the procedure of renal transplantation, the graft could be damaged by     ischemia-reperfusion which generates complications in its function.      Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,     which could be beneficial in renal transplantation.   "
71056|NCT02355691|"     For the target population of adult patients following primary total hip arthroplasty, the     randomized clinical trial will be used to evaluate the efficacy of the use of a mobile     negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in     the immediate postoperative period. We will apply two dressing types and evaluate the     postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple     variables of wound infection risk.   "
71057|NCT02355678|"     Tonsillectomy is one of the most frequent surgical operations performed in children [1-4]. It     is usually associated with postoperative nausea and vomiting (PONV) with an incidence ranging     from 23% to 73% [2]. Dexamethasone has been shown to be effective in reducing PONV after     tonsillectomy using standardized anesthetic technique [2, 5-7]. Previous studies utilizing a     different technique, the pre-incision infiltration of local anesthesia, had shown to decrease     post-tonsillectomy pain, reduce analgesic consumption and provide a rapid return to normal     activity [8, 9]. Given the effectiveness of dexamethasone and the pre-incision infiltration     anesthetic technique, it would be beneficial to compare the effect of each on PONV.   "
71058|NCT02355665|"     The purpose of this study is to assess the efficacy and safety of a novel nicotine product     for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments     of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.   "
71059|NCT02355652|"     The goal of this prospective randomized double-blind study is to compare clinical and     radiological results of cemented and uncemented total knee arthroplasty (TKA).      Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented     TKA.      The primary outcome is the comparison of the International Knee Society (IKS) Score revised     in 2011 at one year postoperative.      The second outcome is the comparison of standard one year-postoperative x-rays looking for     signs of loosening.   "
71060|NCT02355639|"     The purpose of this study is to assess steroid induced skin atrophy by sonography.   "
71061|NCT02355626|"     Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to     a threat. Anxiety is a consequence of the reciprocal interaction between stress and the     neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of     anxiety in critically ill patients has never been done. Our hypothesis is that high levels of     anxiety at ICU admission are associated with death or the occurrence of one or more organ     failure during the first 7 days, and that anxiety should be considered as a warning sign in     critically ill patients.   "
71062|NCT02355613|"     Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife     radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients   "
71063|NCT02355600|"     Survival in young patients with cancer has increased and also have increased the adverse     long-term side effects of chemotherapy, there is a large number of women who experience loss     of ovarian function without accomplishing their reproductive desire due to gonadotoxic     treatment. The ovarian reserve determine the response to controlled ovarian hyperstimulation     in fertility preservation treatments as well as in assisted reproduction techniques.     Improving this reserve by avoiding its depletion during the process could result in increase     fertility rates after cancer treatment.      Collecting follicles during tamoxifen treatment would increase the number of cryopreserved     oocytes and thus rise the potential ovarian reserve in these patients, which is reduced due     to age, chemotherapy and length of treatments.      The aim of this study is to retrieve viable mature oocytes during adjuvancy with tamoxifen in     breast cancer patients to improve the probability of subsequent pregnancy.   "
72181|NCT02340949|"     This trial compares induction treatment with FOLFOX with or without aflibercept in a high     risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine     combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of     pCR.   "
71064|NCT02355587|"     The EXPAND Registry Study follows patients with cutaneous melanoma who have had the     DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will     be collected through review of medical records from clinical visits with physician.      The purpose is to document the clinical application of results obtained from the DecisionDx-     Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma     testing has been completed. Additionally the study will assess the health economic impact of     DecisionDx-Melanoma testing as it relates to the Melanoma population.   "
71065|NCT02355574|"     The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the     DecisionDx-Melanoma gene expression assay performed. Data will be collected through review of     medical records from clinical visits with physician.      The purpose is to document the clinical application of results obtained from the DecisionDx-     Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma     testing has been completed. Additionally the study will assess the health economic impact of     DecisionDx-Melanoma testing as it relates to the Melanoma population.   "
71066|NCT02355561|"     The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the     rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation     in healthy elderly participants.   "
71067|NCT02355548|"     This study is looking at the safety and effectiveness of treating Patients diagnosed with a     low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient     hospitalization. Patients have several medical tests done during their Emergency Department     visit. Based on those tests, those who are determined to have a low-risk PE are eligible to     participate in the study. Those choosing to participate are discharged after 12 hours of     medical observation. Patients who choose to participate are followed up by telephone     approximately 90 days later.   "
71068|NCT02355535|"     This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a     small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer     cells, in patients with advanced malignancies. PAC-1 is taken orally on days 1-21 of a 28-day     cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a     modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease progression,     unacceptable toxicity, physician discretion, or patient refusal.   "
71069|NCT02355522|"     This is a randomized, double-blinded, double placebo-controlled trial. Patients undergoing     saline infusion sonohysterography (SIS) will be recruited and randomized into three groups to     receive (a) 3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline; (b)     3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine or (c) 3ml of KY jelly on     the cervix and 5mL of intrauterine normal saline prior to SIS. Pain levels will be recorded     to evaluate the efficacy of local lidocaine gel and intrauterine lidocaine infusion in     reducing pain during the SIS.   "
71070|NCT02355509|"     Is a randomized, double-blind, placebo-controlled trial to determine the behavior of     hyperglycemia and postprandial lipemia after a standard mixed meal load in patients with     carbohydrate intolerance treated with acarbose.   "
71071|NCT02355496|"     This is a clinical trial to evaluate the impact of presenting medicare fee data for inpatient     laboratory tests in the electronic health record on provider ordering behavior at a tertiary     care hospital.   "
71072|NCT02355483|"     The purpose of this study is to determine whether non-contrast abdominal computed tomography     (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients     admitted to the emergency department with abdominal pain.   "
71073|NCT02355470|"     This study will offer the first formal assessment for sexual violence (SV) in the college     student health center setting, developed for a high risk group of college students, and is     designed to facilitate patient and provider comfort in discussing sexual violence and related     abusive experiences (including the role of alcohol) via semi-scripted screening tools. The     intervention specifically involves the training of all clinical staff (health educators,     counselors, medical assistants, nurses, and clinicians) to deliver a universal education and     brief counseling intervention titled GIFTSS (Giving Information for Trauma Support and     Safety) to all clients seeking college health services integrated into usual clinical     practice, provide universal education about SV regardless of disclosure, counsel clients on     harm reduction strategies to reduce risk for SV, and provide supported referrals to sexual     assault advocates, with the goal of reducing SV among college students.   "
71074|NCT02355457|"     The primary aim of the study is to investigate new cardiac biomarkers and algorithms to     diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.   "
71075|NCT02355444|"     Cardiovascular disease (CVD) is the most common cause of death in Ireland, accounting for 33%     of all deaths. Hypertension or elevated blood pressure, is also a significant health problem,     however, it is one of the major controllable risk factors associated with CVD. While     increased consumption of fruit and vegetables is associated with reduced risk of CVD,     evidence is accumulating that consumption of berry fruits in particular, may promote     cardiovascular health. Blackberries have a favourable nutritional profile, in that they are     rich in dietary fibre, vitamins C, K and folate but low in dietary fat and kilocalories. In     addition, blackberries are a rich source of antioxidants, and contain numerous phytochemicals     including polyphenols. The aim of this study is to investigate the potential beneficial     effects of blackberry consumption on cardiovascular health, in particular, effects on blood     pressure.   "
71076|NCT02355431|"     The purpose of this study is to determine if INCB039110 in combination with erlotinib is safe     and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is     Stage IIIB/Stage IV or recurrent whose tumors have EGFR activating mutations.   "
71077|NCT02355418|"     This study investigates the hypothesis that diffuse interstitial cardiac fibrosis develops in     response to chronic volume overload from severe degenerative mitral regurgitation. The     investigators will investigate the functional (exercise) and symptomatic (PROMS) outcomes of     patients with severe but asymptomatic mitral regurgitation who have the option of choosing     surgical repair or watchful waiting.   "
71078|NCT02355405|"     Lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing perioperative     atelectasis and evaluating its severity in adult patients undergoing general anesthesia in     the operating room.   "
71080|NCT02355379|"     Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France     more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more.     Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall     survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is     poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is     suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly     patients in this study were highly selected and patients older than 80 represented only 0.7%     of the total population. Thus, there is still a concern about the benefit of adjuvant     5FU-based chemotherapy in very elderly unselected patients.      The recommended treatment for stage III adjuvant chemotherapy is a combination of     fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival     advantage in elderly patients.      Altogether there are still two matters of debate:        -  First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit          elderly patients?        -  Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly          patients? The aim of this randomized phase III study is to evaluate the benefit for          disease-free survival of adjuvant chemotherapy in elderly patient and which          chemotherapy.      The elderly patient population will be dichotomized into two groups according to physician's     choice after a multidisciplinary evaluation involving a geriatrician, with two different     randomization assignments. The patients with an expected life-expectancy below 4 years     according Lee score are excluded of this study.      Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch     repair deficiency), therefore an evaluation of specific biological prognostic factors is     needed in elderly population.   "
71081|NCT02355366|"     The present study aims to examine the effects of a 4 month, family focused therapy (FFT)     intervention on the 1 year course of mood symptoms in offspring of parents with bipolar     disorder (BD). The study will also examine the level of expressed emotion among families and     how this impacts on FFT treatment outcomes. This study seeks to replicate a previous study by     Miklowitz, Schneck, Singh, Taylor, George and colleagues (2013), which demonstrated the     efficacy of FFT among BD offspring. Importantly, the present study will introduce biological     measures that predict and reflect improvement in symptoms and expressed emotion. These     markers reflect stress-related biological systems and include saliva samples to ascertain     cortisol, interleukin-6 (IL-6) and salivary alpha amylase (sAA).   "
71082|NCT02355353|"     The primary objective of this study is to correlate the percentage change in apparent     diffusion coefficient (ADC) between baseline and early therapy (at day 14) with tumor     regression grade (TRG) measured in the surgical resection specimen.   "
71084|NCT02355327|"     This feasibility trial aims at assessing practical issues and feasibility of a future     randomised controlled trial (RCT) to determine the effectiveness of vibrating vaginal pelvic     floor training balls for postpartum pelvic floor muscle rehabilitation, at monitoring harms     of the experimental intervention, and at exploring women´s perspectives on and experiences     with the interventions and the trial.   "
71085|NCT02355314|"     Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains     associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria     (oliguria and serum creatinine elevation), which carry several important limitations.     Additionally, the investigators lack biomarker that may predict short term renal prognosis.      Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative     tool that may hold promise for early AKI detection in ICU patients or in differentiating     transient from persistent AKI in selected critically ill patients. Although several studies     have suggested adequate performance in predicting short-term reversibility of AKI, most of     these studies were performed in limited patient samples. Additionally, a recent study has     identified discrepant results regarding its diagnostic performance.      The main objective of this large prospective multicentre study is to assess diagnostic     performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically     ill patients requiring mechanical ventilation.   "
71086|NCT02355301|"     The main objective of the investigators is to improve the quality of care in patients with     orthopedic disorders followed in St Luc hospital (Brussels Belgium). To do this, the     investigators want to assess the impact of Orthopedic treatments at the structural level     (bone structure, muscle, etc.), at the functional level (mobility, strength, stiffness...),     on the restriction of activities of patients (walking, make its care daily..) and on the     limitation of participation in the life of every day (sport, work, social life, cultural...).     This functional evaluation of patients with orthopedic disorders by the ICF model is an     original approach rarely used in muscular-skeletal impairments that can very improve the     management of these patients and their quality of life. In addition, the investigators     associate the harvesting of all medical and computer data collected by high-precision tools     in the surgical treatments, to better define the surgical precision and improve the quality     of surgical care.   "
71087|NCT02355288|"     The purpose of this study is to evaluate whether less invasive bypass surgery using the left     chest wall artery is more or less effective than inserting a heart stent in patients with     diabetes and a blockage of the main artery at the front of the heart. This will be a clinical     trial study where the investigators will test the rate of recruitment into the study, as well     as the feasibility of allocating each of the 2 treatments.   "
71088|NCT02355275|"     The purpose of this study is to determine the effectiveness of a Thera-Band based home     exercise program (HEP) on LBP and disability 4 weeks post treatment discharge.   "
71089|NCT02355262|"     This randomized research trial studies the Community-based Health Information Technology     (HIT) Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP) intervention in     increasing cancer screening and prevention care in uninsured patients at community health     centers. The CATCH-UP intervention may contribute to increased rates of insurance coverage,     leading to improved cancer screening and prevention rates in community health care settings,     and general recommended preventive care.   "
71090|NCT02355249|"     This study is a multi-center, randomized, and open-label trial to compare the safety and     feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic     esophagectomy for esophageal cancer.   "
71091|NCT02355236|"     Naxozol is a combination product of naproxen, a non-steroidal anti-inflammatory drug (NSAID)     and esomeprazole, a proton pump inhibitor which is designed to improve symptoms and reduce     risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers in     the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The     purpose of this study is to investigate whether naxozol protects the gastrointestinal tract     effectively compared to celecoxib, a COX-2 inhibitor.   "
71092|NCT02355223|"     The study is designed to evaluate the clinical impact of a novel strategy for tuberculosis     (TB) infection control known as FAST (Find cases Actively based on cough surveillance,     Separate temporarily, and Treat effectively). It is anticipated that this will decrease time     to effective treatment initiation and also decrease transmission of TB to health care     workers.   "
71093|NCT02355210|"     This study evaluates the effect of a dietary supplement to improve gut health. The     participants will take one of six dietary treatments for three weeks, and the gut bacteria     and the gut intestinal barrier will be assessed to determine if these dietary treatments     beneficially change these markers of gut health.   "
71094|NCT02355197|"     Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32 weeks     and high blood sugar levels were found so Cases were controlled by both diet and insulin.      The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web     based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid (vitamin C     )per day from the time of diagnosis until the time of delivery in addition to routine     treatment of diabetes (diet & insulin). Group2 received only the treatment of diabetes   "
71095|NCT02355184|"     This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term     efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral     suppression in patients who were stable on combination antiretroviral therapy and completed     12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing     virologic failure.      Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks.     Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of     existing retroviral regimen and PRO 140 at the end of the treatment extension phase in     subjects who do not experience virologic failure.   "
71096|NCT02355171|"     The 'Personalize My treatment' (PMT) platform is a novel form of biobanking in which cancer     patients willingly consent to provide residual, clinical samples (surplus after diagnostic     testing) of their tumors for cancer research, to give access to their medical record for data     collection and then followed prospectively throughout the trajectory of their illness. They     further willingly consent to be recontacted for being informed of other research projects,     including clinical trials.   "
71097|NCT02355158|"     Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of     Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their     12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this     study and receive active study drug in an open-label manner.   "
71098|NCT02355145|"     A non-interventional, multicentre study to observe the main criteria used in clinical     practice by physicians when selecting the second-line add-on therapy in patients with     inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Data     will be collected by reviewing the medical records of patients with type 2 diabetes and     add-on therapies at the time of presenting to endocrinologist according to clinical practice.     The patients will participate in only one study visit, at the time of enrolment. Two study     groups are to be defined at two time-points.   "
71099|NCT02355132|"     This study examines the impact of a randomized insurance experiment on preventive services     receipt and healthcare utilization in safety net patients using linked public insurance     claims and safety net clinics' electronic health record (EHR) data.   "
71100|NCT02355119|"     Patients with resected pancreatic cancer who fulfill the selection criteria will be     randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine,     the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin     and Irinotecan), the experimental arm.      A total of 310 patients will be enrolled in about 50 Italian centers.   "
71101|NCT02355106|"     The objective of the study is to demonstrate the safety and feasibility of the Adagio System     in subjects with Atrial Flutter.   "
71102|NCT02355093|"     This study aims to compare continuous femoral nerve block with adductor canal block after     anterior cruciate ligament reconstruction arthroscopically，especially in the effect on     quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients     postoperatively.   "
71103|NCT02355080|"     This is a randomized controlled clinical trial in which adults receiving drug abuse treatment     will be recruited to participate in a HIV and hepatitis C (HCV) testing study. The purpose of     this study is to test the efficacy of two HIV/HCV testing strategies on increasing receipt of     test results: (1) on-site bundled rapid HIV/HCV testing (i.e., joint offer of HIV and HCV at     the point of encounter), and (2) standard of care for HIV and HCV testing.   "
71104|NCT02355067|"     This study is intended to compare the acceptability and feasibility and explore outcomes     related to two different formats of a parenting program for mothers with postpartum     depressive symptoms. One version will be a traditional, in-person group format, while the     other will be a social media group format. The investigators will also explore the     differences in outcomes of both formats, looking at depressive symptoms, parenting sense of     competency, and parenting interactions with children.   "
71105|NCT02355054|"     The purpose of this study is to provide clinical access to PET/CT and PET/MRI with C-11     choline for evaluation of men with biochemically recurrent prostate cancer while awaiting     approval of the Washington University Abbreviated New Drug Application for C-11 choline.   "
71106|NCT02355041|"     Adolescent obesity is associated with a number of serious health conditions and most obese     adolescents become obese adults. Despite this fact, very few adolescent health centers offer     clinical weight loss programs. This is likely because most weight loss programs require     extensive resources and are not covered by most health insurance policies. However, this is     expected to change since the American Medical Association's recent decision to recognize     obesity as a disease. Therefore, it is important to identify simple and effective nonsurgical     programs for weight loss, which can be used in adolescent health centers. The investigators     are proposing to show that a meal replacement based diet program will be effective in     reducing body mass index (weight adjusted for height). In this pilot study, 90 adolescents     will either participate in a meal replacement based weight loss program or watch an     educational video. Body mass index and body fat will be recorded over time to see if     adolescents participating in the meal replacement program lose more weight than those who do     not participate in this program.      In order to address this objective, the investigators will assess group differences in body     mass index (BMI; kg/m2), body composition (% body fat), eating disorder symptoms and     psychological/behavioral variables.   "
72509|NCT02336659|"     The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones     (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after     Roux-en-Y gastric bypass surgery.   "
71107|NCT02355028|"     The purpose of this study is to evaluate the efficacy of 84 successive days of topically     administered LHA510 compared to vehicle in reducing the number of patients requiring     intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for     recurrence of active choroidal neovascularization (CNV).   "
71108|NCT02355015|"     The study aims to address the following aims        1. To provide an overview of the epidemiology of the patients who are managed in the          Singapore General Hospital for NTM infections.        2. To evaluate the medical care of patients in the institution with regards to the type of          medical and/or surgical treatment received and specifically, the antibiotic regime and          duration administered.        3. A longitudinal follow up which will allow an assessment of our care and patient outcome          in this population cohort   "
71109|NCT02355002|"     The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic     stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive     compulsive disorder. Additionally, this study aims to identify the mechanisms of action of     TMS and potential biomarkers and predictors of treatment response.   "
71110|NCT02354989|"     The purpose of this study is to evaluate the effect on distance covered in a 6 minute walking     test of Rate Responsive pacing in patients with permanent atrial fibrillation and reduced     left ventricular ejection fraction treated with atrioventricular junction ablation and     biventricular pacing.   "
71111|NCT02354976|"     This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study     performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and     fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with     over-weight and hypertriglyceridemia.   "
71112|NCT02354963|"     This study aims to assess whether activation of primordial follicles through ovarian cortex     fragmentation may increase the number of antral follicles present in the ovary of patients     with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and     pregnancy rates after IVF.      Hypothesis; Evaluate whether the proposed intervention increases the pool of antral follicles     (potentially stimulable ones).   "
71113|NCT02354950|"     This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in     adults with moderate and mild (if needed) hepatic impairment and matched, healthy control     subjects with normal hepatic function. In Part 1, healthy control subjects (n=8) matched to     subjects with moderate (n=8) hepatic impairment will be enrolled. If the geometric mean total     plasma area under the concentration-time curve from time zero (pre-dose) extrapolated to     infinite time (AUC[0-infinity]) of GSK1265744 is increased by >2-fold in moderately impaired     subjects relative to matched controls, Part 2 will be conducted to evaluate GSK1265744 PK in     subjects with mild hepatic impairment (n=8) and matched, control subjects (n=8). All subjects     will receive a single 30 milligram (mg) oral dose of GSK1265744. The primary objective of the     study is to compare plasma PK parameters of GSK1265744 in subjects with hepatic impairment to     healthy controls matched in gender, age, and body mass index (BMI).   "
71114|NCT02354937|"     GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development     for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal     elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine after     a single 30 mg radiolabeled dose. Despite the minimal contribution of renal clearance on     overall 744 elimination, renal impairment may potentially inhibit some pathways of hepatic     and gut drug metabolism and transport, and as a result may impact 744 pharmacokinetics. The     current Food and Drug Administration (FDA) draft guidance for renal impairment studies     suggests that a pharmacokinetic (PK) study in patients with renal impairment be conducted     even for those drugs primarily metabolized or secreted in bile.      The study will be comprised of two cohorts (severe renal impairment and normal renal     function) of 8 subjects each. Upon enrolment, each subject will be admitted to the study     center and undergo serial PK sampling following a single dose of oral 744 30 milligrams (mg).     Subjects will return to the clinic for follow-up evaluations 10-14 days after the 744 30 mg     dose.   "
71115|NCT02354924|"     The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens     could be prescribed as a supportive care for myopic persons.   "
71116|NCT02354911|"     The purpose of this study is to determine whether dendritic cells collected via leukapheresis     and incubated with antisense DNA oligonucleotides and then injected back into the same     subject will serve as modulators of the immune system in a manner that disrupts the     autoimmune process responsible for the destruction of pancreatic beta cells in subjects with     new onset type 1 diabetes.   "
71117|NCT02354898|"     This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or     BBI503 in combination with Sorafenib. This study population is adult patients with advanced     solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in     combination therapy.   "
71118|NCT02354885|"     Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic     acid (TXA) seems to improve survival and outcome. Thus this study evaluates the     administration of TXA on scene by the emergency medical services (EMS) or by the crew of a     rescue helicopter in multiple trauma patients or isolated traumatic brain injury (TBI).     Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry.   "
71129|NCT02354742|"     Echocardiography (cardiac ultrasound) is being used more often in the critical care setting     for management of severe infection (septic shock). Early studies show echocardiography to be     useful in these patients, but at this time, there are no good clinical trials to justify its     use.      Our study goals/objectives are as follows:        1. To conduct an unblinded, two-group randomized controlled clinical trial to compare an          echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy          (EGDT) protocol in patients with severe sepsis or septic shock.        2. Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and          other non-invasive assessments of cardiac output will result in more rapid resolution of          septic shock compared to invasive EGDT.        3. Demonstrate patients receiving the non-invasive echocardiography protocol will receive          less administration of intravenous fluid.   "
72510|NCT02336646|"     Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions     using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study     in treating 18 recipients with ischemic limb diseases.   "
71119|NCT02354872|"     The ultimate goal of this research is to develop a chronic care treatment package for smokers     that will address the challenges and opportunities of each phase of the cessation process -     motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop     treatments for smokers not yet ready to quit, those who are preparing to quit, those actively     engaged in the quitting process and those who have tried to quit but relapsed. To achieve     this goal, this research comprises three distinct research studies, each of which represent a     phase in a comprehensive chronic care treatment model for clinical intervention with smokers     in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term     Quitting Study. The goal of each study is to test and identify effective intervention     components for distinct phases of the smoking cessation process. These components will then     be combined for future research on the effectiveness of this chronic care treatment package.     This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two     levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral     Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs     Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4)     Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling.     These components have strong theoretical and empirical support, but their relative, additive,     and interactive effects are unknown.   "
71120|NCT02354859|"     The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary     function as measured by a 5% or greater relative improvement in forced expiratory volume in     one second (FEV1) from baseline to Day 28.      Funding Source - FDA OOPD   "
71121|NCT02354846|"     An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy     with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving     Rituximab-CHOP Chemotherapy (SPEED study)   "
71122|NCT02354833|"     The purpose of the study is to determine if a medication called phenylephrine, which helps to     control blood pressure, is more effective as a continuous intravenous (IV) infusion compared     to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for     a cesarean delivery. Good blood pressure control has been shown to decrease nausea and     vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean     delivery, all participants will receive spinal anesthesia with a local anesthetic and     morphine (provides long term pain control after cesarean delivery). This study plans to     enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned     according to a computer generated system to be in one of two groups.   "
71123|NCT02354820|"     This project seeks to expand an existing computerized decision support system used in     pediatric primary care. The expanded system will add a module that helps clinicians recognize     constipated children and then provides evidence-based reminders for constipation management,     as well as automates patient educational materials. The current system is deployed across     multiple sites, and the constipation module will be randomized to deployment in different     sites. The difference in constipation management and patient outcomes will then be compared     between sites receiving the intervention and sites not receiving the intervention over a 12     month period.   "
71124|NCT02354807|"     To determine whether pharmacological stimulation of supraclavicular Brown Adipose Tissue (BAT     or Brown Fat) and subcutaneous White Adipose Tissue (WAT) using an FDA-approved beta3     agonist is as effective in increasing oxidative metabolism in BAT and WAT as is the exposure     to cold, the investigators will assess the efficacy of an FDA approved beta3 agonist     Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) for increasing oxidative metabolism     in supraclavicular BAT and subcutaneous WAT in lean and obese young adults.      The investigators anticipate that both methods to stimulate supraclavicular BAT and     subcutaneous WAT will result in similar 18F-labeled fluoro-deoxyglucose (FDG) tracer uptake     on positron emission tomography (PET) images as well as oxidative metabolism. This would     demonstrate that pharmacological stimulation of BAT is effective and could lead to further,     more detailed clinical trials in obese subjects.   "
71125|NCT02354794|"     The purpose of this study is to determine whether oral supplementation with one form of     arginine improves vascular endothelial function in healthy subjects with risk factors     associated with the metabolic syndrome   "
71126|NCT02354781|"     The proposed clinical trial is an outgrowth of the safety record and functional improvement     seen in the BMD follistatin gene therapy trial. In this study the investigators propose to     inject AAV1.CMV.huFS344 at a total dose of 2.4E12 vg/kg to six DMD patients. This dose will     be divided between gluteal muscles, quadriceps and tibialis anterior. This is a wider     distribution of vector than given to BMD patients, who overall improved the distance walked     on the 6MWT without adverse events related to viral transduction into a single muscle.   "
71127|NCT02354768|"     Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30     days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and     renal failure. Nowadays, there are no recommendations nor national nor international for high     output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice,     somatostatin analogs have proven efficacy in the literature. Theses analogs permit to     decrease significantly gastrointestinal secretions. Several teams use these analogs in order     to decrease the flow of highly productive ileostomy.      The aim of the study is to evaluate the efficacy first line treatment with lanreotide     associated with current anti-diarrheal treatment for patients with high output ileostomy (or     greater throughput 1.5l / 24h) with or without associated dehydration   "
71128|NCT02354755|"     The purpose of the current study is to examine whether changes in intraoperative ambient     temperature has in impact on the clinical performance of the physicians in training which     include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists     (CRNA). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT,     Ambulatory Monitoring Inc., NY) device.   "
71130|NCT02354729|"     Fifteen million Americans suffer from food allergies. Food allergies can be life threatening;     the only known life-saving treatment is epinephrine. Adolescents/young adults are at     increased risk of adverse events, because of increased risk-taking with food and decreased     likelihood of carrying epinephrine. This is a pilot randomized trial to test text message     reminders, with and without financial incentives, to encourage allergic young adults to carry     epinephrine.   "
71131|NCT02354716|"     The purpose of this study is to investigate the use of a functional luminal imaging probe to     characterize benign esophageal luminal strictures before and after dilation and identify     predictors of response to therapy. Patients will be evaluated during endoscopy using     functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to     characterize the geometry of benign luminal esophageal narrowing before and after dilation.   "
71132|NCT02354703|"     The primary study objective is to determine the efficacy of ondansetron (0.33 mg twice daily)     administered orally for a period of 16 weeks in reducing risky drinking among currently     drinking subjects with alcohol use disorder who have selected genotypes at the serotonin     transporter and receptor genes. The secondary objective is to assess the safety and     tolerability of ondansetron in subjects with alcohol use disorder who have selected genotypes     at the serotonin transporter and receptor genes.   "
71133|NCT02354690|"     Background:      Adoptive T cell therapy with tumor infiltrating lymphocytes (TILs) has been reported to     induce durable clinical responses in patients with metastatic melanoma. From patients own     tumor material T cells are extracted, expanded and activated in vitro in a 4-6 weeks culture     period. Before TIL infusion patients are preconditioned with a lymphodepleting     chemotherapeutic regimen. After TIL infusion, patients are treated with IL-2 to support T     cell activation and expansion in vivo.      The BRAF inhibitor is an approved treatment of metastatic melanoma and functions by     selectively inhibiting the BRAF mutated enzyme, consequently halting the proliferation of     tumor cells. Furthermore, in vitro tests have shown that vemurafenib has immunomodulatory     effects that are hypothesized to synergize with TIL therapy, which has been confirmed in     animal studies.      Objectives:        -  To evaluate safety and feasibility when combining vemurafenib and ACT with TILs.        -  To evaluate treatment related immune responses        -  To evaluate clinical efficacy      Design:        -  Patients will be screened with a physical exam, medical history, blood samples and ECG.        -  Patients will start vemurafenib 960 mg BID and will continue during TIL preparation.        -  7 days after start of vemurafenib, patients will undergo surgery to harvest tumor          material for TIL production.        -  Patient stops vemurafenib and is admitted day -8 in order to undergo lymphodepleting          chemotherapy with cyclophosphamide and fludara starting day -7.        -  On day 0 patients receive TIL infusion and shortly after starts IL-2 infusion          continually following the decrescendo regimen.        -  The patients will followed until progression or up to 5 years.   "
71134|NCT02354677|"     COPD is characterized by exagerated decline FEV1 related to obstructive non reversible     airflow. This could be the consequence of structural changes and inflammatory pattern of the     bronchial wall. Lesions could lead to normal but also abnormal remodeling specially in COPD     including a decrease in Club cells number and function.There is no treatment actually     available targeted to a normal repair of the epithelium. The objective of this work is to     identify potential targets for reprograming bronchial epithelial cells I order to achieve a     good repair.   "
71135|NCT02354664|"     This study intends to evaluate dynamic respiratory motor performance as a valuable measure of     pulmonary function in adults with late-onset Pompe disease. The investigators will adopt a     strategy that includes comprehensive evaluations of respiratory volume, flow, and timing     parameters during resting and loaded breathing. These evaluations will then be associated to     the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle     function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic     descent at rest and with exertion. Outcomes in participants with late-onset Pompe disease     will be contrasted to the function of age- and gender-matched control subjects. This approach     will enable the investigators to evaluate the relationship between dynamic diaphragmatic     function and respiratory motor function.   "
71136|NCT02354651|"     The purpose of this study is to determine the effect of diaphragm pacing on respiratory     function in subjects with Pompe disease by evaluating the duration and pattern of spontaneous     respiratory function versus paced ventilation respiratory function in patients with Pompe     disease who have received the NeuDx Diaphragm pacer (DPS).   "
71137|NCT02354638|"     In addition to the passengers smoking inside the cab, the taxi drivers,are themselves     addicted to smoking and/ or use of smokeless tobacco. Since tobacco is highly addictive, the     cab drivers using tobacco need help in quitting. It is also necessary to raise the awareness     of the cab drivers with respect to the hazards of tobacco and significance of the smoke free     legislation.      It's been six years since the implementation of rules prohibiting smoking in public places     and a re-look at the compliance to this regulation is necessary. The study will also help     tobacco users to quit their habits. They will get screened for oral premalignant and     malignant lesions.      Also, the cab drivers may pass on some effective messages regarding importance of keeping     oneself away from tobacco, to the customers while commuting. In view of the above background,     the current study is proposed to look at all these aspects.      The findings of the study will be certainly generating useful information with regards to     lacunae in the existing system for appropriate implementation and for strengthening anti     tobacco advocacy in our country.   "
71138|NCT02354625|"     The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC)     transplantation in participants with chronic SCI.      This trial design is phase I, open label, unblinded, non-randomized, and non-placebo     controlled multiple injury cohorts.   "
71139|NCT02354612|"     This is a multicenter, open-label, non-randomized, study of TRC105 in patients that have     completed a previous TRC105 study and are judged by the investigator to have the potential to     benefit from continued TRC105 therapy.   "
71140|NCT02354599|"     The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of     single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male     participants.   "
71141|NCT02354586|"     This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of     niraparib in ovarian cancer patients who have received three or four previous chemotherapy     regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once     daily continuously during a 28-day cycle. Health-related quality of life will be measured by     Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be     assessed by clinical review of adverse events (AEs), physical examinations,     electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.   "
71142|NCT02354573|"     What is heart failure with normal ejection fraction? The heart contracts (pumps) and relaxes     with each heartbeat. In some people with heart failure, the heart contracts normally but     there is reduced relaxation of the heart. As a result, people notice a feeling of     breathlessness, ankle swelling and fatigue especially on exertion.      The investigators feel that patients with reduced or impaired relaxation of the heart have     less heart filling time and poor energy utilisation during exercise. Therefore, the     investigators are conducting a study to more thoroughly understand the disease condition by     giving a drug called ivabradine to reduce the heart rate and hence to increase the heart     filling time in these patients.   "
71143|NCT02354560|"     Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world     with a lifetime risk of 6%. Etiology is complex, while genetic background significantly     affects the risk. Around one third of all genetic disorders as well as most cases of Familial     Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a     result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous     polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that     prematurely halt the protein translation process, producing a shortened, nonfunctional     protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop     codon signal, the resulting protein may be able to ameliorate or stop the disease.      Recently, members of the aminoglycoside family of antibiotics have been found to induce     ribosomal read-through of nonsense mutations, leading to expression of a full length,     functional protein. Investigators have recently shown that members of the aminoglycoside and     macrolide antibiotic families can induce read-through of the nonsense mutations in the APC     gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.      The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin     to induce read-through of the nonsense mutations in the APC gene and to induce expression of     a full length, functional APC protein in patients suffering from FAP and to tests its effect     on adenoma number and size and on desmoid tumors in these patients. The future goal is to     maximize the effect of stop-codon suppressors on APC while minimizing side effects.      In this study investigators will select FAP patients which carry APC nonsense mutations,     treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as     well as abdominal desmoid tumors, that will be documented before during and after treatment.     In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as     blood samples from these patients for changes in expression levels of the APC protein and     related oncogenic markers.      Suppression of nonsense mutations within the APC gene should be of benefit for patients     suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or     diffuse CRC. Furthermore, given the rapid progress being made in the identification of     different nonsense mutations in human genes that lead to mostly un-curable disease, the     identification of clinically approved compounds that suppress nonsense mutations and that can     be administered long-term without significant side effects would open new venues in the     treatment of genetic human diseases that arise from pre-mature stop codons in important     coding sequences.      Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation     in FAP patients. The read-through effect of erythromycin will be clinically tested by     counting and measuring the number and size of both colonic and duodenal adenomas before and     over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and     desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry     for restoration of APC expression and changes in oncogenic markers. These experiments should     be conducted within 6 month.      Long term objective:        1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia          and CRC in patients expressing a truncated APC protein due to nonsense mutations.        2. Examine the ability of a panel of additional macrolide antibiotics to induce APC          nonsense mutation suppression using in-vitro methods. Investigators will focus on          macrolide antibiotics that are currently in clinical use and are administrated for long          terms. These objectives should take around 6 month and will be conducted in parallel.   "
71144|NCT02354547|"     The purpose of this study is to determine the dose limiting toxicities and recommended phase     2 dose of SGT-53 alone and in combination with topotecan and cyclophosphamide in pediatric     patients with recurrent or refractory solid tumors.   "
71145|NCT02354534|"     This phase I research protocol is designed to assess immunogenicity and clinical endpoints in     patients with HPV16 CIN2/3. The protocol tests the use of artesunate in suppository     formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).      The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility     of intravaginal administration of artesunate in health women with CIN2/3.   "
71146|NCT02354521|"     An observational, point-prevalence cohort study of nutrition therapies in critically ill     children in PICUs across the world. Baseline information will be collected including PICU and     hospital demographics and characteristics (e.g. age, diagnostic category, PRISM score,     weight, height) of critically ill children requiring mechanical ventilation in the PICU.     Nutrition practices such as route of nutrition, kilocalorie and protein levels prescribed and     received, interruptions, etc., will be collected on a daily basis from PICU admission     onwards, for a maximum of 10 days. Data on clinical outcomes (e.g. duration of mechanical     ventilation, PICU stay, hospital stay, acquired infections) will be collected up to 60 days     after admission to the PICU. The main objective of the study is to examine the association     between energy and protein intake adequacy (in relation to the prescribed goals for these     nutrients) and 60-day mortality in mechanically ventilated children.   "
71215|NCT02353624|"     The aim of this study was to test the physiological response to a 2800 km cycling expedition,     from Copenhagen, Denmark to Nordkapp, Norway, in a group of older male recreational cyclists.   "
71147|NCT02354508|"     This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and     safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly     with maximal approved doses of first generation somatostatin analogues. The study will enroll     inadequately controlled patients by high doses (maximal approved) of first-generation     somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40     mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of     core phase and have completed all the assessments at the core phase completion visit can move     into the 32-week extension phase. Patients can continue with study treatment until     pasireotide LAR is commercially available and reimbursed in their respective country or until     the end of the extension phase whichever occurs first.   "
71148|NCT02354495|"     The investigators aim to examine the feasibility of individualized diet intervention in     children dependent on long-term mechanical ventilator support at home. The investigators will     use a multidisciplinary model that will allow for diet modification based on comprehensive     nutrition, metabolic and respiratory assessments performed in the subjects' home. the impact     of this intervention (for 12 weeks) on body composition and respiratory variables will be     assessed.   "
71149|NCT02354482|"     Funded by the Patient Centered Outcome Research Institute (PCORI), nationally recognized     leaders in health care and research methods are partnering with patients and caregivers to     evaluate the effectiveness of current efforts at improving care transitions and develop     recommendations on best practices for patient-centered care transitions and guidance for     spreading them across the U.S.   "
71150|NCT02354469|"     Recently, researchers and clinicians have examined many different forms of concussion testing     aimed to assess if a brain injury has occurred and to what degree it affects the individual     being tested. Due to the multifaceted and complex presentation of concussive injuries and the     unknown effects of repeated head trauma, it is unlikely that a single test of physiological     or behavioral function will reflect the full range of injury-related damages from a     concussive event or from a series of cumulative head traumas, as well as the injury response     within brain tissue. However, by combining a variety of objective assessments which may     detect structural and functional alterations following head trauma into a single study, a     clearer understanding of the multi-faceted presentation resulting from head trauma may be     identified. The identification of biomarkers and the utilization of objective and clinically     feasible tools will provide a method to assess three domains across multiple systems affected     by head trauma: 1) the prognostic value of initial concussion assessments to identify injury     severity and factors responsible for prolonged recovery, 2) the temporal window of recovery     and potential vulnerability of brain tissue post-injury, and 3) the long-term alterations     associated with repeated head trauma exposure.   "
71151|NCT02354456|"     Atrial fibrillation (AF) is one of the most common cause of preventable ischemic stroke and     associated with increased cardiovascular morbidity and mortality. Our previous AFTER study     demonstrated the general epidemiological data about the patients with valvular and     nonvalvular AF in Turkey. However, data is lacking about the use of new oral anticoagulants     (NOACs), time in therapeutic INR range (TTR) in vitamin K antagonist users and AF management     modality in our country. In this multicenter trial the investigators aimed to analyze, follow     and evaluate the epidemiological data in non-valvular AF patients.   "
71152|NCT02354443|"     The purpose of this study is to describe the safety profile of ProHema-CB as part of a single     cord blood unit transplant after a myeloablative conditioning regimen in pediatric patients     with inherited metabolic disorders. The safety profile will primarily be assessed by     neutrophil engraftment.   "
71153|NCT02354430|"     To investigate the possible effect of an unsupervised water-exercise program, on the     intensity of low back pain and the number of days spent on sick leave, among healthy pregnant     women Our hypothesis is, that 45 minutes of water exercise twice a week for a period of 12     weeks during pregnancy, will reduce the intensity of low back pain and the days spent on sick     leave.   "
71155|NCT02354404|"     Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety,     tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP     (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with the     VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2.      Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1     will include at least 60 volunteers who have never received an investigational Ebola vaccine.     Randomizations to cAd3-EBO at two different dose levels within Group 2 may include up to 30     eligible participants who previously participated in the RV 247 vaccine clinical trial and     received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine.      Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine     at the same dose level.   "
71156|NCT02354391|"     The objective of this study is to determine the efficacy, safety, and patient satisfaction of     pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy     (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical     treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test     group and the control group. Each patient will have four distinct treatment areas of 25cm2 on     the scalp, and/or scalp and face. Three of the treatment areas will receive Picato® 0.015%     gel, MAL PDT, or Picato® 0.015% and MAL PDT combined. One area will serve as a control and     will receive none of the treatments.   "
71157|NCT02354378|"     The goal of this study is to determine the effects of dexmedetomidine on memory and recall of     children who are receiving dexmedetomidine sedation administered for magnetic resonance     imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for     diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at     Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in     children has not been studied.   "
71337|NCT02351999|"     The study is a prospective, multi-center, non-randomized single arm interventional     investigation with the TSP Crosser Transseptal Access System, a new complete solution for     transseptal puncture and left atrial access and catheter navigation, for patients with atrial     fibrillation ablation referred for radiofrequency catheter ablation.   "
71158|NCT02354365|"     Typically doctors adjust the settings on the ventilator to ensure that children receive     enough help to decrease the work they perform to breathe, receive enough oxygen through the     machine to pass into the blood and to the organs, and remove acid that builds up in the     blood. However, sometimes the settings we choose can result in damage to the lungs. We are     trying to find a better way to determine the best ventilator settings, which can minimize     potential damage to the lungs, and still provide children with enough support to decrease the     work they have to do to breathe. We believe we can personalize these choices for each child     by looking at the pressure that is generated in the chest while children breathe with the     ventilator. This is accomplished by using a small tube which goes through the nose and into     the esophagus or stomach, which is hooked up to a computer or the ventilator to monitor     pressure. This same tube can then also be used to monitor how much work children need to do     to breathe as we are turning down the ventilator in preparation to remove the breathing tube.   "
71159|NCT02354352|"     The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving     cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with     Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be     enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will     use a drug diary to record daily compliance of taking the study medication as well as any     concerns they may have during the study period. Subjects will undergo cardiac magnetic     resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12     months post enrollment. Subjects will also complete a quality of life questionnaire at     baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at     baseline and 12 months.   "
71160|NCT02354339|"     The metabolic syndrome is a high prevalence disease worldwide. About a quarter of the adult     population suffers from the disease and predispose the onset of diseases like cardiovascular     disease and diabetes mellitus type 2.      The first line of treatment for metabolic syndrome is diet and exercise but patients have a     low attachment to the treatment, so pharmacologic therapy is required. There is no a single     drug that could help to the treatment of all metabolic syndrome components.      Irvingia gabonensis, better known as African mango, is widely consumed in central and western     Africa, mainly the fruit and seeds. Besides being part of the diet of African the seeds have     been used for the treatment of diseases such as dysentery, diabetes and as an analgesic.      Resent investigations have demonstrated that an extract of African mango seeds induce     significantly weight loss in subjects with obesity, and also improves some biochemical     parameters such as glucose and the lipid profile.      The aim of this study is to evaluate the effect of Irvingia gabonensis on metabolic syndrome,     insulin secretion and insulin sensitivity.   "
71161|NCT02354326|"     This clinical trial studies dual energy computed tomography (CT) in finding cancer that has     spread from the original (primary) tumor to the bone (bone metastases) in patients with     cancer. Diagnostic procedures, such as dual energy CT, may help find and diagnose bone     metastases and may be more accurate compared to single energy CT alone.   "
71162|NCT02354313|"     A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus     observation after intensified induction regimen containing rituximab followed by high dose     chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult     patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208).   "
71163|NCT02354300|"     Flow diverters have been approved since 2012 for the treatment of large, wide neck     intracranial aneurysms. These devices have been associated with embolic events which cause     blockage in a blood vessel and can result in long term complications. One possible cause of     these events is the formation of small emboli during placement of the device.   "
71185|NCT02354014|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores     what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in     children and adolescents (0 months to less than [<] 18 years of age) diagnosed with confirmed     or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a     Background Regimen (BR) of MDR-TB Medications.   "
71164|NCT02354287|"     There is no consensus method for removal of diminutive (5mm) to small(6-9mm) colorectal     polyps at colonoscopy. Neither the European Society of Gastrointestinal Endoscopy or the     American Society of Gastrointestinal Endoscopy have guidelines for the removal of these     polyps, despite the fact that around 90% of lesions removed by polypectomy at colonoscopy are     diminutive to small.      Multiple techniques are used for polyp removal, especially diminutive lesions. These include     either forceps, both hot and cold, as well as snare with electrocautery or cold snare.     Forceps utilises shearing force to grasp tissue and remove it, with the hot method passing a     current through the grasper to essentially burn tissue. Snare is the use of a small metal     loop placed and tightened at the base of polyps to cut through the tissue either straight     away in a cold method or with electrocautery where a small current is passed through the loop     to assist cutting through tissue. Surveys of Colonoscopists and Gastroenterologists in     Australia and the United States show that the choice of method used for diminutive to small     polyps is highly variable with cold snaring marginally favoured.Studies into polypectomy     techniques are limited and it is clear that additional data and the review of polypectomy     methods needs to be undertaken in order determine the optimal method for the removal of     diminutive and small colorectal polyps.      A technique is used at the Gloucestershire National Health Service (NHS) trust involving a     submucosal pre injection with a standard solution then the use of cold forceps for removal of     polyps ≤7mm. This appears to be both very safe and highly effective method for the removal of     these lesions compared to other techniques. No formal published studies have been completed     to evaluate this method at national and international levels. We propose a study to evaluate     the effectiveness, safety and costs of this method.   "
71165|NCT02354274|"     To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on     an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a     standard homogeneous dose spread   "
71166|NCT02354261|"     The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell     Carcinoma Nevus Syndrome.   "
71167|NCT02354248|"     TST (Triple stimulation technique) helps to better quantify the proportion of motor units     activated by transcranial magnetic stimulation. The abnormal amplitude registered by TST is     proportional to the intensity of conduction disorders. The evaluation of these disorders is     more precise with this technique than with the slowing of the central conduction time (CCT).      The investigators propose to use this technique in CNS pathologies where this disorder is     significant and essential, like multiple sclerosis and stroke.   "
71168|NCT02354235|"     The purpose of this study is to evaluate the efficacy and safety of co-administration of     Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese     patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and     have inadequate glycemic control.   "
71169|NCT02354222|"     The purpose of this study is to evaluate the efficacy and safety of co-administration of     Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese     patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and     have inadequate glycemic control.   "
77374|NCT02273089|"     This study intends to determine whether continuous positive airway pressure (CPAP) can reduce     arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy     patients with obstructive sleep apnea .   "
71170|NCT02354209|"     The purpose of the study is to look at possible reasons why some HIV positive people who take     their drugs properly and have no resistance to these drugs, still have low amounts of virus     detectable in their blood. This is known as Low Level Viraemia (LLV). When low levels of HIV     virus are present, some can mutate and make the drugs less effective (i.e. some variants of     the virus become more resistant). Currently, however, these resistance mutations may be     difficult to detect using standard tests for resistance because the amount of virus in the     blood is very low and the standard tests aren't sensitive enough to pick up the mutations.     The investigators will use more sensitive mutation detection methods, known as Next     Generation Sequencing (NGS), to look at whether see if there are any low levels of drug     resistant HIV virus developing in the blood when LLV occurs. The investigators will look at     the different treatment strategies that are used in routine standard practice when LLV is     detected and evaluate which is most effective in preventing development of resistance. The     investigators hope this research will help to inform guidelines on the best way to treat HIV     in the future.   "
71171|NCT02354196|"     To determine the total plaque burden, plaque severity and composition of patients undergoing     Cardiac CT who do not have any previous history of CVD. There are two cohorts:        1. A retrospective follow-up for MACE endpoints of patients who underwent a CCTA >1 year          ago as part of the Big PICTURE Trial, who meet the inclusion criteria of Big PICTURE 2.        2. A prospective observational registry of patients referred to undergo CCTA with a 1 and 2          year follow-up.   "
71172|NCT02354183|"     Research suggests that individuals with Borderline Personality Disorder (BPD) experience low     motivation for change (Skodal, Buckley, & Charles, 1983). Dialectical Behavior Therapy (DBT;     Linehan, 1993) includes commitment strategies that are designed to improve motivation. No     studies have examined the effectiveness of these strategies. The proposed study will evaluate     the efficacy of a brief DBT intervention consisting of commitment strategies plus skills     training for people who self-harm. Participants will be randomly assigned to either a single     orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation.     Immediately following their orientation session, all participants will be enrolled in a 90     minute group skills training session. Primary outcomes include autonomous motivation and     frequency of self harm behaviours. Assessments will be conducted at six time points:     baseline, after the initial orientation session, after the skills training group session, and     at one week, one month, and three month follow-up   "
71173|NCT02354170|"     The goal of the study is to assess the efficacy and safety of mifepristone 300 or 900-mg     once-daily dosing by mouth for 4 weeks in patients with central serous chorioretinopathy.   "
71174|NCT02354157|"     Control rules are common parental practices that use food as reward to encourage children to     conduct parents' preferred behaviors. This field observational study aims to examine whether     control rules are associated with children's increased fat, carbohydrate and total energy     intake in everyday eating, and whether this effect is moderated by individual differences in     sensitivity to reward, and by gender differences.   "
71197|NCT02353858|"     The current trial is evaluating the impact of deep regional hyperthermia on the pathological     complete response rate in locally advanced rectal cancer in the context of preoperative 5FU     based radiochemotherapy.   "
71198|NCT02353845|"     One purpose of this study is to construct the diagnosis system for early Alzheimer's     disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then further     construct the predictable classifier from aMCI to AD based on Multi-Modality MRI     characteristics of aMCI patients.   "
72511|NCT02336633|"     The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the     caudate volume in HD patients, using volumetric MRI.   "
71175|NCT02354144|"     The LIMIT-Study is a placebo-controlled, double-blinded randomized controlled trial designed     to explore the efficacy of a carrageenan-based lubricant as a topical microbicide for     preventing HPV acquisition. Individuals at high risk for infection (men who have sex with     men, or MSM, and especially those with HIV) will be included in the trial. Participants will     complete a self-administered baseline questionnaire during the enrolment visit, and follow-up     questionnaires during all other six visits. The shorter follow-up questionnaires are intended     to evaluate recent sexual behaviours and to corroborate the responses given during the     baseline visit. These questionnaires will measure HPV risk factors, compliance, and monitor     safety and tolerability of the gels. Between follow-up visits, participants will be asked to     log into a secure web module at least once a week to answer questions on daily sexual     activities, condom and study gel use, and adverse evens. Individuals will be screened for     eligibility over the telephone or in person and eligible men will attend an enrolment visit,     where the nurse will obtain informed consent and instruct the participant on gel use. They     will receive a one month's supply of gel and provide the first specimen. Random number sets     will be assigned to the treatment and control gel. Each participant will be assigned an     individual code, which will be used to match him to the study arm. Lastly, the nurse will     provide details about HPV infection and advice about condom use and sexual health. HPV     infection status will be measured using anal specimens at baseline (enrolment/time 0), and at     all follow-up clinic visits (1, 2, 3, 6, 9 and 12 months).   "
71176|NCT02354131|"     Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2     (Randomized Phase 2): to compare Progression-Free Survival (PFS)      PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer;     the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as     in gBRCAwt, HRD population but also in HRD negative disease.      In the same population there is level one evidence that bevacizumab is beneficial. And a     phase two randomized study has indicated that combination of a PARP inhibitor with     anti-angiogenic drug is superior to PARP inhibitor alone.      The question is:      Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability     and efficacy of niraparib-bevacizumab combination against niraparib.   "
71177|NCT02354118|"     The purpose of this study is to determine the safest and most effective flushing solution for     maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in     patients whose ports are flushed with saline only will be compared to the complication rate     in patients whose ports are flushed with a combination of saline and heparinized saline.   "
71178|NCT02354105|"     The primary purpose is to assess the effectiveness of certolizumab pegol in patients with     axial spondyloarthritis under routine clinical practice.   "
71179|NCT02354092|"     Cervical dilators are frequently used for preparation prior to second trimester surgical     abortion. While their use decreases complications associated with surgical abortion, their     placement is often uncomfortable for the patient. Currently there are no proven methods for     reducing pain during osmotic dilator placement. The use of numbing medication around the     cervix (paracervical block) may decrease this placement pain.   "
71180|NCT02354079|"     The aim of this study is to identify new targets in cholesterol metabolism thanks to a     genetically-based strategy.   "
71181|NCT02354066|"     Patients often seek advice from their treating doctor if they are able to drive with a foot     orthosis after a first metatarsal osteotomy for symptomatic hallux valgus and/or after an     additional forefoot surgery. This challenging question is of obvious importance for the     patient and other road users. Previous studies already issued driving ability after different     orthopedic procedures and with knee and ankle devices on the brake reaction time but missed     to address the same for foot orthoses after hallux valgus or forefoot surgery.      This missing evidence made us evaluate the influence of wearing a foot orthosis after a first     metatarsal osteotomy or forefoot surgery on driving ability (brake response time; BRT).      The overall time frame is about nine weeks; each appointment for BRT measurement takes about     fifteen to twenty minutes. The first BRT measurement is one day before the foot surgery     without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2),     two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and     eight weeks postoperative without a foot orthoses (6).   "
71182|NCT02354053|"     Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored     therapy for HIV patients. While modern regimens have improved the rates of virologic     suppression overall and reduced adverse effects of antiretroviral treatment, an important     sub-group of HIV infected persons is unable to maintain adherence to their treatment     regimens, fail to achieve long term virologic control and remain at risk for HIV related     disease progression and transmission of HIV infection.      Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with     adherence support will improve the rate of HIV suppression in vulnerable populations     non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50     copies/mL at Week 24 post randomization.   "
71183|NCT02354040|"     Although most patients admitted with acute coronary syndrome or acute ischemic stroke in     South Asian countries receive these evidence-based treatments, their overall continuation in     the outpatient phase of care remains low. Patient from Pakistan are uniquely challenged in     this respect because the overall literacy rates remain one of the lowest in Pakistan among     South Asian Countries. In addition, a great majority of Pakistani patients often do not     understand or follow health prescriptions (which are still written in English). Additionally,     due to an unregulated health industry, they frequently take multiple opinions and     prescriptions from different physicians. The investigators propose to develop a talking     prescription for patients with stroke or myocardial infarction for secondary prevention.     This will enable them to understand their medications better, improve health literacy and     adherence. This is an IT enabled health literacy intervention. Physicians will prescribe     statin and/or antiplatelet to the selected patients and enter the necessary details on an     Optical Mark Recognition (OMR) sheet.Patients will be assigned to either of the 2     arms--either regular care or talking prescriptions. Follow-up will be done at 3 months post     recruitment for behavioral knowledge assessment and adherence assessment.   "
71184|NCT02354027|"     The purpose of the study is to investigate the potential interaction between multiple oral     doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.   "
71186|NCT02354001|"     The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in     the treatment of young women with schizophrenia and schizoaffective disorder. Raloxifene is a     Selective Estrogen Receptor Modulator (SERM),which means that it can affect the central     nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory,     information processing and concentration), without adversely affecting reproductive     tissue/organs such as breast, uterus and ovaries. The investigators are conducting a     double-blind, placebo controlled, three month study comparing the psychotic symptom response     of women with schizophrenia in both groups. One group will receive standard antipsychotic     medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic     medication plus oral placebo.   "
71187|NCT02353988|"     Growing studies demonstrated that Androgen Receptor (AR) has an oncogenic role for the     patients with AR-positive Triple Negative Breast Cancer (TNBC). AR antagonists in therapy,     such as bicalutamide, completely binds to the AR, increasing AR degradation, thus are     investigated for the efficacy of the treatment of patients with AR-positive TNBC in the     study.   "
71188|NCT02353975|"     This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted     or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the     pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.   "
71189|NCT02353962|"     The aim of this study is to evaluate the feasibility and usability of newly developed     exergames on exploring the hemineglected space of left neglected stroke patients. Furthermore     to understand the experience of living with visuospatial neglect and to explore the users'     experiences (patients and clinic staff) with those new exergames.   "
71190|NCT02353949|"     The study examines subjects where there might be an indication for Amyloid-PET according to     the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a     Flutemetamol-Positron-Emission-Tomography -Scan (PET) on clinical management and disease     course will be studied over 6 months.   "
71216|NCT02353611|"     Bleaching protocol In each session, volunteers received prophylaxis with pumice powder and     water. Then, gingival tissue was protected using a light-cured resin gum barrier applied     according to the manufacturer's instructions (Lase Protect - DMC, São Carlos, SP, Brazil).     Both bleaching agents were prepared by mixing hydrogen peroxide and thickening compounds     according to the manufacturer's instructions (with 3 peroxide drops for 1 drop of thickener).     The resultant gels were distributed uniformly on the upper hemiarcade surfaces of the teeth.     A total of 8 teeth between the first premolars were bleached for each patient. In each     bleaching session, the bleaching gels were applied twice for 12 minutes each. In each     application, the surface of the gel was light activated with continuous irradiance for 12     minutes using LED/laser light with a total power of 1800 mW (Whitening Lase Plus - DMC     Equipamentos, São Carlos, SP, Brazil). Three bleaching sessions were completed for the     patients, and the interval between sessions was 7 days   "
71191|NCT02353936|"     As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib showed the     possibility of superior effects to 1st generation TKIs such as erlotinib and gefitinib. In a     phase III study LUX-lung 3 in patients with EGFR mutation-positive non-small-cell lung     cancer, afatinib monotherapy showed longer progression-free disease survival time of 11.1     months than that (6.9 months) of pemetrexed/cisplatin combination therapy. Based on such the     results, it is currently recommended as the standard first-line treatment for EGFR     mutation-positive lung cancer, and clinical studies are also being actively conducted in     other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty (30)     solid cancer patients were included in a phase I trial of afatinib, and of them, a patient     with esophageal cancer had partial response. Taken together, based upon the results from     clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients achieved     clinical responses of 3 months or longer.      Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and     our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation     EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer characterized     by well-known EGFR overexpression. In this phase II trial, afatinib shall be administered to     patients with squamous cell carcinoma of esophagus to evaluate its effects and toxicity.     Also, biomarkers to predict responses to afatinib shall be explored through further studies.   "
71192|NCT02353923|"     The purpose of this study is to determine whether supplementation with OcuStem, a nutritional     supplement, will reduce the progression of mild to moderate diabetic retinopathy.   "
71193|NCT02353910|"     Prospective studies on the incidence of VTE during severe sepsis and septic shock remain     absent, hindering efficacy assessments regarding current VTE prevention strategies in septic     patients. The investigators will prospectively study consecutively enrolled ICU patients with     severe sepsis and septic shock admitted at three hospitals. All patients will provide     informed consent and the study will be IRB approved. VTE thromboprophylaxis, provided per     standard of care and according to the patients' primary team, will be recorded for all     patients. Patients will undergo bilateral lower (and upper, if a central venous catheter     [CVC] was present) comprehensive compression ultrasonography (CUS) and will be followed for     symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. The     investigators will perform multivariate regression analyses to identify predictors of VTE.   "
71194|NCT02353897|"     This study aims to look at patient and physician satisfaction of long term Glabellar lines     (GL) treatment with Dysport in a real life setting. It will also allow better understanding     of what patients expect from the treatment, and the injection practices used by doctors.   "
71195|NCT02353884|"     The purpose of this study is to find the characteristics of mild cognitive impairment (MCI)     using technology of Multi-Modality MRI , including structural MRI, functional MRI and     diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp) and     stable MCI (MCIs) and further construct the predictable classifier from MCI to Alzheimer's     disease (AD) based on Multi-Modality MRI characteristics of MCI patients.   "
71196|NCT02353871|"     The purpose of the protocol is to demonstrate the safety and the efficacy of a single     treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin     complex (BTX A HAC; hereafter referred to as BTX A HAC Next Generation (BTX A HAC NG)), used     for the improvement in the appearance of moderate to severe glabellar lines (the lines     between the eyebrows).   "
71199|NCT02353832|"     The purpose is to determine if use of rectal spacers are effective at improving protection of     rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of     acute effects. It is also to determine whether it provides sufficient dosimetric benefits to     warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation)     related clinical studies.   "
71200|NCT02353819|"     Since high risk prostate cancer requires higher radiation, this study is being done to     determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to     determine the feasibility and safety of each treatment fraction by using cone-beam Computed     Tomography(CT) information and high speed Graphics Processing Unit based computation     treatment planning systems. We also plan to determine the safety of treatment to the     prostate. Health-related quality of life will be measured as part of current clinical     practice.        -  Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic          nodal using 90 day acute toxicity endpoint        -  Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal          region at each treatment fraction by using cone-beam CT (CBCT) information and high          speed GPU based computation treatment planning systems        -  Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy          total dose) to the prostate        -  To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS),          distant metastasis (DM) free survival, and overall survival (OS)        -  Health-related quality of life (HRQOL) will be measured as part of current clinical          practice Patients in each dose cohort will all be treated as a single group for dose          escalation. There will be two levels of dose escalation—to prostate lesions and to          pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per          fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences.          The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per          fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will          receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting          dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive          an additional 0.5Gy per treatment (total of 2.5Gy per escalation).   "
71201|NCT02353806|"     This is a phase IV prospective trial to collect and analyze information about the maternal     pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum     lactation. The study will also evaluate amlodipine concentrations in the infants of     breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.   "
71202|NCT02353793|"     Hypothermia is a common problem in traumatized patients leading to severe complications such     as impaired coagulation, increased rate of wound infections and overall patient discomfort     among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket     device against the currently used cotton wool blanket in terms of effects on the prevention     and treatment of hypothermia.   "
71242|NCT02353247|"     The overall objective of this study is to confirm that oral progesterone is an effective way     to manage bothersome bleeding; thus increasing the rate of continuation of the etonogestrel     contraceptive implant in adolescents.   "
71203|NCT02353780|"     An Agency for Healthcare Research and Quality executive summary indicated that better     comparative effectiveness trial designs are needed to determine the relative merits of     existing versus new and expensive biologic drug therapies for rheumatoid arthritis (RA).     There are now 9 biologic therapies approved for treating RA. Four classes of biologics (TNF     antagonists, B-cell inhibitors, T-cell co-stimulator blocker, and Interleukin-6 receptor     blocker) are approved for use in RA patients with moderate or severe disease activity.     Several critical questions have arisen, such as 1) what therapy should be prescribed after     failure of methotrexate and/or other oral disease modifying antirheumatic drugs (DMARDs) to     adequately control disease activity; 2) what is the level of efficacy of the various biologic     therapies when compared in head-to-head trials; and 3) what are the mechanisms associated     with failure of methotrexate and/or other oral DMARD therapy and responsiveness to biologic     therapies. The MAZERATI study will provide the foundation for answering these questions and     determining the mechanisms associated with these biologic therapies.   "
71204|NCT02353767|"     This study aims to estimate the prevalence of bridging liver fibrosis and cirrhosis (METAVIR     score ≥ F2) according to METAVIR score in HIV infected patients not chronically infected by     viral hepatitis but exhibiting a metabolic syndrome according to the IDF definition     (International Diabetes Foundation).   "
71205|NCT02353754|"     This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the     transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in     subjects undergoing elective Cesarean section (C-section).   "
71206|NCT02353741|"     This single-arm phase II study aims to study the efficacy of a possible first line treatment     that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with     concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with     active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this     new combinational therapy can benefit short-term and long-term survival of the patients with     advanced NSCLC.   "
71207|NCT02353728|"     The study is an open-label phase 2 clinical and translational trial designed to evaluate the     effects of nilotinib on the leukemic stem cell population in subjects with newly diagnosed     chronic phase chronic myeloid leukemia (Ph+ CML in CP). Nilotinib is FDA-approved to treat     subjects with Ph+ CML in CP. Subjects on study will be monitored according to accepted     National Cancer Comprehensive Network [NCCN] clinical guidelines for 24 months. After 24     months, if continued therapy is needed subjects will be transitioned to commercial supply of     study drug.   "
71208|NCT02353715|"     This is a pilot exercise physiology and quality of life study of subjects receiving standard     of care therapy for their prostate cancer using FDA-approved drugs per their labeling     (abiraterone, enzalutamide, or sipuleucel-T). Subjects with progressive, asymptomatic or     minimally symptomatic mCRPC scheduled to be treated with either enzalutamide or abiraterone     acetate for ≥3 months or a course of sipuleucel-T will be allocated to one of the treatments     arms, according to the treatment chosen by the treating physician.   "
71209|NCT02353702|"     Upper abdominal surgery is known to induce such pulmonary complications as pneumonia,     atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to     these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a     recognized tool for measuring the diaphragmatic function.The purpose of this study is to     evaluate the effectiveness of parietal analgesia with continuous infiltration of local     anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal     incision. Our main outcome is to measure the diaphragmatic function with the sniff test in 44     patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our     secondary outcomes are the evaluation of the effect of continuous parietal analgesia with     ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications and     post operative recovery. This prospective study will determine if the pre peritoneal local     infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.   "
71211|NCT02353676|"     Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative     recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is     at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine     hydrochloride for the surgical removal of lower third molars with a postoperative 0.5%     bupivacaine supplementation would result in lesser postoperative pain and a decrease in     ingestion of oral analgesics to control the pain when compared to a placebo.   "
71212|NCT02353663|"     Rheumatic heart disease remains a major challenge in low and middle income countries. Early     detection of clinically silent valvular lesions by screening echocardiography allows timely     implementation of secondary antibiotic prevention, and may prevent progression of disease to     severe valvular damage and heart failure. The objective of the study is to assess the     prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently,     the investigators will evaluate progression of disease in children with early stages of     subclinical rheumatic heart disease.      The investigators will perform a population-based observational survey for rheumatic heart     disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly     selected public and private schools. Rheumatic heart disease will be documented both     according to the modified World Health Organization definition and the echocardiographic     criteria suggested by the World Heart Federation.   "
71213|NCT02353650|"     The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a     naturally low Q10 level will be selected out of a preselected group of 160 screened out of a     pre-existed database or patients which visited the ENT-consultation. The 40 patients with the     lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the     effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and     auditory evoked responses will be used as outcome measurements.   "
71214|NCT02353637|"     The aim of the study is to investigate, in severely obese adolescents, the effects of a high     protein, restricted carbohydrates utilizing partial meal replacements diet (HPRC-PMR) on     weight loss, body composition, and bio-chemical markers of lipid metabolism, insulin     resistance, and inflammation over a 12 months period.   "
71217|NCT02353598|"     This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the     safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72     participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination     [MMSE] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered     after the completion of initial double-blind stage.   "
71218|NCT02353585|"     The present study will monitor and explore acute neurovascular emergencies in patients     treated with NOACs compared to those under treatment with VKAs. The primary aims of this     study are: (1) To investigate characteristics, management and outcome of intracranial     hemorrhage (ICH) in patients treated with NOAC compared to VKA. (2) To investigate the     management and outcome of patients with acute ischaemic stroke under NOAC compared to VKA.   "
71219|NCT02353572|"     This phase I/II trial studies the safety and best dose of melphalan and bortezomib when given     prior to an autologous stem cell transplant and to see how well they work in treating     patients with multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Bortezomib may help melphalan work     better by making cancer cells more sensitive to the drug. Giving chemotherapy before an     autologous hematopoietic stem cell transplant helps kill any cancer cells that are in the     body and helps make room in the patient's bone marrow for new blood-forming cells (stem     cells) to grow. After treatment, stem cells are collected from the patient's blood and     stored. More chemotherapy is then given to prepare the bone marrow for the stem cell     transplant. The stem cells are then returned to the patient to replace the blood-forming     cells that were destroyed by the chemotherapy. Giving melphalan together with bortezomib     prior to autologous hematopoietic stem cell transplant may be a better treatment for multiple     myeloma.   "
71220|NCT02353559|"     The purpose of this study is to test the feasibility of an individual psychological and     physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to     reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute     leukemia.   "
71221|NCT02353546|"     Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to alleviate     distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was associated     with reductions in depressive symptoms and death anxiety and an increase in spiritual     wellbeing. The purpose of this study is to assess the feasibility of a large-scale randomized     controlled trial (RCT) of CALM and to identify preliminary effects in advanced cancer. This     phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month follow-ups.     The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes included diagnosis     of major depression (SCID), death anxiety, attachment security and spiritual wellbeing.     Multilevel regression was used to compare change over time between groups. 60 patients with     advanced cancer will be recruited from the Princess Margaret Cancer Centre, Toronto, Canada,     and equally randomized into intervention and usual care conditions.   "
71222|NCT02353533|"     Adenomatous lesions of the colon are premalignant lesions which have the potential to develop     cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR).     EMR is conducted after submucosal injection of saline which allows to lift the desired lesion     prior to resection. In some cases EMR is complicated due to incomplete or failed lifting     after the injection of saline. This so- called non- lifting sign is a predictor for     malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher     proportion of these lesions fail to be resected completely using the EMR technique.      Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in     order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et     al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the     performance of FTRD resection compared to standard EMR resection of difficult- to- resect     colon adenomas.      In this study the investigators aim to compare the success of FTRD versus EMR of difficult-     to- resect adenomatous lesions (≤ 20 mm).   "
72512|NCT02336620|"     The Purpose of this study is to determine the impact of balanced salt solution versus     chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock   "
71223|NCT02353520|"     Initially, a written consent was obtained from each participant. Then they became familiar     with the procedure. For intrarater reliability, the first rater assessed the strength of     pinch grip, elbow flexion and shoulder abduction in three different sessions at short     intervals on same day in same environmental conditions. All the assessments were performed on     the same day in three sessions. Assessment duration of all the sessions was 5 minutes.      For inter-rater reliability, Before the beginning of Procedure both the raters were     familiarized with the motricity index. The motricity index was administered by two different     raters on the same subjects within 2 days who were blind to each others results and heir     results were recorded separately.   "
71224|NCT02353507|"     The purpose of this prospective, randomized, comparative multi-center study is to compare the     effective management of two silver-based dressings in managing exudative wounds in first and     second degree burns.   "
71225|NCT02353494|"     This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in     Timika, Indonesia with a 42 day follow up period.   "
71226|NCT02353481|"     The aim of the study is to develop and assess a prognostic model for patient's survival up to     1 year after unscheduled acute heart failure hospital admission in England and Wales.   "
71227|NCT02353468|"     This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone     together works in treating patients with multiple myeloma undergoing stem cell transplant.     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and     dexamethasone together may kill more cancer cells.   "
71253|NCT02353104|"     This open-label, adaptive-design, pilot study was designed to evaluate the effect of     Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in     systolic and diastolic blood pressures. The effect of the product on glucose metabolism,     lipid levels, and antioxidant levels would also be determined. Tolerability and safety of the     study product would also be investigated.   "
71228|NCT02353455|"     Drug metabolism in the liver is subject to large fluctuations (differences between women and     men, people of different ethnic backgrounds, children and adults). These large differences     are responsible for very different drug effects and side-effects (and especially liver damage     caused by drugs) between individuals. Recent scientific findings suggest that blood derived     cells can be used to model individual effects of drugs on the liver reflect inter-individual     differences. Since liver damage caused by drugs is a diagnosis of exclusion, the     aforementioned cells can be used to identify patients that show higher sensitivity to     hepatotoxic side-effects and - in case several drugs are involved - identify the causal agent     or possible interactions.   "
71229|NCT02353442|"     To identify biomechanical and sensibility changes in people with posterior capsule tightness     in people with and without shoulder pain.   "
71230|NCT02353429|"     This is a prospective study evaluating the activity and the safety of toremifene in patients     with primary or recurrent sporadic DTs.      Patients will be enrolled after the histological confirmation of DTs on biopsy Patients will     start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will be     performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale (VAS)     every 3 months for the first and second year, twice yearly thereafter. Response will be     evaluated either by RECIST and/or symptomatic relief.   "
71231|NCT02353416|"     Advanced glycation end products (AGE) result from a chemical reaction between the carbonyl     group of reducing sugar and the nucleophilic NH2 of a free amino acid or a protein; lysine     and arginine being the main reactive amino acids on proteins. Following this first step, a     molecular rearrangement occurs, rearrangement of Amadori resulting to the formation of     Maillard products.   "
71232|NCT02353403|"     The study aims to evaluate the glycaemic and insulinaemic response of short-chain     fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.   "
71233|NCT02353390|"     This is a randomized controlled open-label trial. During the study, adolescents and young     adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either oral     water hydration in addition to standard care or standard of care alone to evaluate the effect     of water hydration on the primary outcome of presyncope. This study will also evaluate the     acceptability of pre-vaccination hydration among adolescents and young adults.   "
71234|NCT02353364|"     The study is designed to evaluate the effectiveness of pre-implantation genetic screening     (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive     treatment. Half of the patients will have their embryos tested by PGS and 1 or 2     chromosomally normal embryos with the highest morphological grading transplanted back to the     uterus. The other half of the participants will not have their embryos tested and 1 or 2     untested embryos with the highest morphological grading transplanted back to the uterus.   "
71235|NCT02353351|"     Prospective, multicenter, case-cohort study.To identify potential risk factors associated     with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)   "
71248|NCT02353169|"     Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain     in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a     potential change in how the heart muscles contract and changes in blood sugar and potassium     levels, are poorly understood. The current study aims to examine these changes directly in     healthy children undergoing elective surgery by measuring the heart beats (with an     electrocardiogram) and blood sugar and potassium at specific times before and after     dexmedetomidine is given. The investigators aim to establish a better understanding of this     drug's safety profile.   "
71249|NCT02353156|"     The investigator will perform a randomized clinical trials to compare the effect of pain     management and wound healing after hemorrhoidectomy between warm sitz bath and electronic     bidet.   "
71250|NCT02353143|"     The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion,     in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and     potential immunogenicity of MEN1112 will be evaluated as well.   "
71236|NCT02353338|"     Background: Wrist fractures are a common injury among people aged 55-70. The radius is one of     the bones making up the wrist joint, and is typically the site of injury in a broken wrist.     Methods of treating a broken radius include placing the wrist in a cast for 6 weeks     (conservative management) or receiving surgery. Surgery allows for earlier movement of the     wrist and return to activity, while being placed in a cast is less invasive than surgery.      Surgery to fix these fractures has become more common; however there is little agreement     about who should receive surgery and who should be placed in a cast to heal. The goal of this     study is to compare outcomes between people aged 55-70 who have broken their wrist and had     surgery, and those who received a cast.      Procedures: Participants in this study will be randomly assigned to one of two study groups     within 1 week of injury at their first clinic visit with the surgeon.      Patients in Group A (surgical management) will continue with casting for a total of 6 weeks,     as indicated by the surgeon.      Patients in Group B (conservative management) will receive surgery, and the attending surgeon     will determine the best fracture fixation method for the wrist.      The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after     the initial injury. At each assessment, the wrist will be examined and participants will be     asked to fill in some questionnaires about health, pain, wrist function, and satisfaction     with the wrist. An X-ray will also be performed on the wrist to assess bone healing.     Information from each visit will be used to determine how participants are doing and to     compare the 2 study groups.   "
71237|NCT02353325|"     Salt is one of the very few regularly purchased food item in all socioeconomic classes     including poor remote areas with subsistence farming. Therefore, it is a promising vehicle     for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the     burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the     sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous     sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in     salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour     change in fortified salt without significantly compromise bioavailability. In the present     project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a     new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family     (EPO).   "
71238|NCT02353312|"     To study the hypothesis that treating patients with underlying diastolic dysfunction with     oral Kuvan® (BH4, also known as tetrahydrobiopterin) in addition to current best practices     will improve metabolic and echocardiographic diastolic function parameters.   "
71239|NCT02353299|"     This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study.     The study will assess the effects of a single dose of Silenor 6 mg compared with matching     placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the     respective T-max in normal healthy adult male volunteers. The study will be conducted in     approximately 52 male subjects   "
71240|NCT02353273|"     The objective of this study is to evaluate the systemic exposures of WH-1 ointment which     includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers     following topical application of WH-1.   "
71241|NCT02353260|"     The purpose of this study is to determine whether Ultrasound Hyperthermia is effective and     safe in the treatment of Oral and Maxillofacial-Head and Neck Cancer.   "
71243|NCT02353234|"     The consumption of wholemeal cereals has been associated with the reduction of several     chronic diseases. The mechanisms behind these protective effects may be linked, besides     dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly,     hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the     highest concentration of ferulic acid, principally contained as monomeric form and diferulic     acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of     the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary     excretion of phenolic metabolites in humans fed with two different kind of a commercial     bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the     pharmacokinetics of the main phenolic compounds was also evaluated by measuring the     circulating metabolites in plasma samples.   "
71244|NCT02353221|"     The CPMC early arthritis registry will recruit participants from a population of new patients     undergoing evaluation at the office of participating physicians. Patients enrolled in the     registry will undergo longitudinal observation and sampling. The investigators will collect     questionnaire data and create a biological sample repository. The information obtained will     be use to generate hypotheses aimed at explaining how environmental and genetic factors are     interrelated to influence UA disease outcomes. Analysis will be performed on the patient's     data and biological samples in order to; A. Assess the epidemiological and clinical     characteristics of patients with early arthritis in the referral pool at CPMC.      B. Analyze the phenotype and genotype of peripheral blood mononuclear cells (PBMC) from     individual patients based on their chemokine/cytokine secretion, cell adhesion molecule     expression, gene expression, DNA methylation and non coding RNA profiles.      C. Generate hypothesis aimed to identify clinical criteria and novel biomarkers to be used in     the diagnosis, prognosis, and therapeutic decisions for patients with early UA   "
71245|NCT02353208|"     Capsule endoscopy is a non-invasive way to examine the small bowel, but its yield is limited     by the battery life. In 20% of cases, the recording stops before the entire length of small     bowel is examined. Capsule transit speed is dependent on bowel motility. When we eat, the     brain sends signal to the bowel to speed up motility. In this study the investigators wish to     determine if chewing bacon (sham feeding) can trick the brain to speed up bowel motility and     improve the rate of complete small bowel examination.   "
71246|NCT02353195|"     The aim of this study was to evaluate the potential clinical benefits of Monopolar Capacitive     Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial chronic neck     pain.   "
71247|NCT02353182|"     Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these     findings are relevant to humans but the issue has become a major concern. Recent data have     found that monkeys exposed to anaesthesia as infants grow up to have slower learning than     those not exposed.      The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic     regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.   "
71251|NCT02353130|"     Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in     response to treatment with Memantine extended release (XR)®, an agent that modulates n-methyl     d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders (ASD) who     clinically demonstrate treatment response.      Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will     exhibit changes in their cortical metrics, which will differ less from neurotypical children.     Subjective ratings of improvement will be correlated with the change in cortical metrics.      The completion of these aims will be essential to design a larger federally funded trial to     validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD sample.     Specifically, the feasibility data obtained may demonstrate the potential for detecting     changes in cortical metrics over time, so that a larger grant could focus on determining how     sensitive and clinically relevant changes in cortical metrics are or may indicate the need to     explore different interventions to use in a validation study. We have chosen to use Memantine     XR® because of its impact on NMDA neurotransmission, its current evaluation in a large     multi-site randomized ASD clinical trial whose initial results are expected shortly, and our     own observations of clinical improvements and good tolerability in the ongoing trial.   "
71252|NCT02353117|"     Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated     that half of them will have adverse birth outcomes. Congenital syphilis remains a major     public health issue, despite the fact that maternal syphilis is easy to detect and treat.     Multiple barriers impair the elimination of congenital syphilis. Syphilis is often     stigmatized and of low priority, and even women attending prenatal care early are potentially     facing multiple clinical barriers. The study objective is to use implementation research     methods to evaluate a multifaceted intervention to increase the use of evidence-based     clinical procedures to prevent congenital syphilis. The investigators will perform a     facility-based, two-arm parallel cluster randomized implementation trial in the Democratic     Republic of the Congo and Zambia. The intervention will be multifaceted, tailored by     formative research, and include: opinion leaders, reminders, monitoring, and feedback;     point-of-care rapid tests; and treatment kits to be used immediately if the rapid test is     positive. Improving syphilis screening and treatment will be promoted as a key step toward     improving the quality of all components of prenatal care.   "
71254|NCT02353091|"     Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer,     middle, inner) are normal but the person has difficulty identifying or discriminating sounds     (Dawes & Bishop, 2009) and experiences listening difficulties in noise. Personal Frequency     Modulation (FM) systems are wireless listening devices that pick up the speaker's voice and     transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient     noise, distance from speaker and reverberation are reduced (Keith & Purdy, 2014).      The principal research question is whether FM systems improve auditory attention, listening     in noise performance and listening in spatialised noise in children with Auditory Processing     Disorder (APD) in relation to just auditory training alone. We hypothesize that the FM system     will lead to improved attention scores, improved speech in noise perception (aided and     unaided) and improved ability to listen in spatialised noise that after prolonged FM use (6     months). Additionally, we hypothesise that these results will correlate with questionnaires     (filled out by parents, teachers and children).      Thirty (30) children with a diagnosis of an APD from the Great Ormond Street Hospital     Audiology clinic will be recruited. The children need to fulfil the following criteria:        1. Diagnosis of APD (based on routine clinical tests at GOSH):             1. Abnormal performance on the auditory figure ground test (a speech in noise test) of               the SCAN-C (i.e. at the 1st percentile score as per UK norms), or in the High-Cue               or Low-Cue score of the LiSN-S test and             2. Abnormal performance in one non-speech auditory processing test (frequency pattern,               duration pattern, gaps in noise or random gap detection pattern tasks), and             3. Parent reported speech in noise and other listening difficulties.        2. No neurological disorder, pervasive or attention deficit disorder or developmental          delay.        3. Normal IQ.        4. Age range 8-11 years.   "
71255|NCT02353078|"     Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic     esophagitis?   "
71256|NCT02353065|"     Colles fractures are a common type of wrist fracture that often requires manipulation in the     Emergency Department. Currently xrays are used to assess whether this has been successful,     which are done once the plaster cast has been applied. This study will assess whether     ultrasound can be used immediately after the manipulation to check the position, before the     plaster cast is applied. This would then be followed by an xray as normal.      The aim is to assess the feasibility of a full study to determine which method is faster,     causes less pain, and also to assess if either approach reduces the need for repeat attempts     at manipulation and surgical repair.   "
71257|NCT02353052|"     Evaluate the reliability of morphology standards for GIST pathologic type, staging and     grading by retrospective analyzing clinical data; on this basis, establish a GIST     standardized and individualized treatment mode to maximum benefit GIST patients, avoid under-     and over-treatment.   "
71258|NCT02353039|"     The purpose of this study is to evaluate the efficacy and safety of the investigational     products in the patients with gastritis during their participation in the study.   "
71259|NCT02353026|"     This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose     of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will     be used, in which single patients will be enrolled to escalating dose levels until a grade 2     or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients     at each dose level until a dose is reached at which 2 or more patients out of 6 experience a     treatment-related toxicity.   "
71260|NCT02353013|"     The investigators will compare weight gain based on fat accretion and change in body     composition in preterm infants receiving different amounts of enteral protein.   "
71261|NCT02353000|"     Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal     survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the     gold standard for patients with more than 3 brain metastases, but has significant side     effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients     with 4 up to 10 BM.   "
71262|NCT02352987|"     This study is designed to find out the effectiveness of combination of ethanol extract of     neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar     arsenical keratosis.   "
71263|NCT02352974|"     The objectives of this study is to        -  Evaluate the safety of giving GAD-Alum (Diamyd) directly into lymph glands in          combination with an oral vitamin D regimen        -  Evaluate how the above mentioned treatments influence the immune system and endogenous          insulin secretion.   "
72513|NCT02336607|"     The purpose of this study is to evaluate the effects on blood pressure control, pulse wave     velocity, as well as safety and tolerability of felodipine single or combine with other drugs     in Chinese Hypertension patients.   "
71264|NCT02352961|"     There are both supply and demand gaps in our understanding of how best to implement MMC     services. In terms of supply of MMC services, there is a need to better understand what the     best way is of efficiently accessing mature men(25-49 years old) . The investigators also     want to understand the type of service delivery approach and environment that would make     mature men(25-49 years old) feel more comfortable when attending an MMC clinic. Demand of MMC     requires identifying messaging that works to address mature men's (25-49 years old) issues so     that they might be willing to undergo MMC. To further advance HIV prevention and advocacy of     male circumcision the investigators also need to consider the perspectives of women on what     approach MMC messaging should take. A combination of male and female viewpoints could inform     MMC outreach messaging where IEC materials are tailored to address the barriers to MMC.     Identifying the specific barriers to MMC among males and including the perspectives   "
71265|NCT02352948|"     This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy     and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1 positive tumours     and the combination of MEDI4736 plus tremelimumab (MEDI4736+treme) versus Standard of Care in     NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with     locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior     systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC.     Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating     mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study     (prospective testing is not planned within this study). The Standard of Care options are: an     EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine     (NAVELBINE®).   "
71266|NCT02352935|"     The purpose of this study is to investigate the safety and efficacy of irreversible     electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free     Survival (PFS) and Over Survival (OS) will be recorded.   "
71267|NCT02352922|"     The investigators are studying ways to improve pain control after surgery. One way to     decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the     operating room. There is an FDA approved extended-release version of a commonly used local     anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are     studying whether using the extended-release medication (Exparel) will give better pain relief     after laparoscopic and robotic-assisted hysterectomies.   "
71268|NCT02352909|"     From a rehabilitation point of view, while several approaches exist to retrain runners with     PFPS, it is not clear which one is most effective, or why. The goals of this     randomised-controlled trial are: 1) to compare the effectiveness of three rehabilitation     programs on pain and functional limitations of runners with PFPS and 2) to explain why the     programs are effective or not based on laboratory analyses. After baseline evaluation,     runners will be randomly assigned to one of three treatment groups, each with a specific     8-week rehabilitation program aimed at addressing the efficiency of a specific type of     retraining. These groups are: 1) Control; 2) muscle recruitment; 3) reducing knee loading     during running.      The investigators hypothesis is that the intervention targeting a reduction in knee loading     will be significantly more effective in reducing symptoms and improving function of runners     with patellofemoral pain syndrome.   "
71269|NCT02352896|"     EPI-743 in Leigh syndrome subjects that participated in previous EPI743-12-002 study.   "
71270|NCT02352883|"     This clinical trial studies magnetic resonance imaging (MRI) and gene expression in     diagnosing patients with abnormal cells in the breast duct that have not spread outside the     duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed     pictures of areas inside the body. MRI may help find and diagnose patients with breast     cancer. It may also help doctors predict a patient's response to treatment and help plan the     best treatment. Genetic studies may help doctors predict the outcome of treatment and the     risk for disease recurrence. Performing MRI with genetic studies may help determine the best     treatment for patients with breast cancer in situ.   "
71271|NCT02352870|"     To explore whether it is feasible to recruit and retain haemodialysis patients into a     randomised controlled trial of online cognitive-behavioural therapy to manage distress   "
71272|NCT02352857|"     The study aims to evaluate the glycaemic and insulinaemic response of short-chain     fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.   "
71273|NCT02352844|"     The purpose of this research study is to look at participants with solid tumor malignancies     and specific mutations respond to treatment with everolimus.   "
71274|NCT02352831|"     There are two parts to this study: the goal of the first part of the study is to find the     best dose of tosedostat when given in combination with capecitabine. The goal of the second     part of the study is to look at how participants respond to treatment with tosedostat and     capecitabine.   "
71275|NCT02352818|"     The aim of this CTO registry is to gather data including patient demographic date, cardiac     risk factors, procedural technical data and procedural success/outcome rates. Furthermore, we     aim to evaluate the safety and performance of various CTO specific guidewires, devices (such     as the CrossBoss/Stingray dissection ren-entry device) and other recognised and approved     techniques (retrograde wire escalation, retrograde dissection re-etry techniques). The     incidence of recognized complications (dissections, perforations, cardiac tamponade, vascular     complications, radiation injury, acute kidney injury) will also evaluated. We will assess     clinical outcome at 1 year after succesful CTO procedures.   "
71276|NCT02352805|"     This observational clinical study investigates cellular and plasmatic activation markers as     well as proteins involved in coagulation and inflammation in patients being connected to     different extracorporeal circulation (ECC) and circulatory support devices under intensive     care conditions.   "
71277|NCT02352792|"     Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a     hypoxia scan either by magnetic resonance tomography, computed tomography or     fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into     standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either     5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the     hypoxic volume applied via simultaneous integrated boost in addition to the standard     treatment (Arm B).   "
71279|NCT02352766|"     Recently, targeted next generation sequencing (NGS) platforms have been introduced that allow     inexpensive testing for hundreds of mutational hotspots at the same time. A number of     additional mutational markers in thyroid cancer have been identified. Highly promising     markers associated with tumor prognosis have also been found. This multi-institutional study     aims to validate the diagnostic use of mutational markers in thyroid nodules with     indeterminate cytology.      The proposed hypothesis is that a broad NGS-based genotyping of thyroid nodules using a large     panel of mutational markers applied to thyroid FNA samples can provide an accurate cancer     risk stratification in thyroid nodules.      The performance of the panel will be tested in a multi-institutional double-blind prospective     study of FNA samples from thyroid nodules with indeterminate cytology and available surgical     outcome   "
71280|NCT02352753|"     This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI     to evaluate efficacy and safety of denosumab.   "
71281|NCT02352740|"     The purpose of this study is to compare the metabolic fate of two oral forms of L-Arginine in     healthy subjects featuring metabolic syndrome related risk factors   "
71282|NCT02352727|"     To quantitative measurement of nocturnal hypokinesia of Parkinson's disease patients compares     with their spouses by using multisite accelerometers for 1 night at their home. To determine     whether the nocturnal movement of Parkinson's disease patients less than normal elderly     people or not.   "
71283|NCT02352714|"     This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual     analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a     paracervical (n=46) block versus a sham paracervical block (n=46).   "
71284|NCT02352701|"     This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg,     Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication     treatment of H.pylori   "
71285|NCT02352688|"     This study evaluates the effects of enhanced geriatric input on elderly patients undergoing     colorectal cancer surgery. Half of the participants will received additional pre, peri and     post-operative care from the geriatric team, while the other half will receive standard     surgical care.   "
71286|NCT02352675|"     Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are     antifibrinolytic agents routinely administered in children undergoing different surgeries     associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries).     Although there is a growing literature regarding the pharmacokinetic characteristics of these     drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis     remains to be determined. In this in vitro study, the investigators will use an experimental     model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the     minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study     will be used to create and validate a new experimental assay to measure fibrinolysis and the     effect of antifibrinolytic agents.   "
71287|NCT02352662|"     This prospective study will aim to globally assess the coagulopathy induced during cardiac     surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators     primary objective will be the understanding of CPB-induced coagulopathy based on demographic     and surgical characteristics, and coagulation assays. Secondary objective will aim at     determining the relationship between coagulation assays, postoperative blood loss, and     transfusion requirements. The ultimate goal will be to design an algorithm using     point-of-care monitoring that could be used to guide hemostatic therapies in neonates and     children undergoing cardiac surgery.To do this, investigators will examine the coagulation in     the laboratory based setting.   "
71288|NCT02352649|"     The purpose of this study is to determine safety and efficacy of pl-vegf165 (Neovasculgen)     for regeneration of peripheral nerve. Pl-vegf165 (Neovasculgen) is the permitted in Russian     Federation angiogenic medication that induce growth of new vessels and included in a complex     therapy for patients with peripheral arterial diseases in Russia. It has also been shown to     enhance nerve regeneration and muscle reinnervation in animals but these properties have not     previously been studied in patients. Moreover, currently there is no method in clinical use     to speed the rate of recovery after nerve injury. The objective of this study is to explore     the ability of pl-vegf165 to benefit the treatment of patients with peripheral nerve injury.     The investigators hypothesize that treatment with intraneural injections with pl-vegf165     after peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period     of denervation and improve muscle reinnervation and recovery in patients with peripheral     nerve injury.   "
71289|NCT02352636|"     Osteoarthritis (OA) is the most common form of arthritis in Hong Kong and a prevalent     condition in the ageing population. With disease progression, some clients may develop severe     pain and profound limitations in ambulation, which may result in morbidity and impaired     physical functions. Among the available treatments, pharmacological therapies primarily focus     on musculoskeletal pain relief. However, adverse effects, such as gastrointestinal     haemorrhage arising from non-steroidal anti-inflammatory drugs have led to an increasing     number of concerns regarding the use of these treatments. Other non-invasive complementary     methods for osteoarthritic knee (OA knee) should be explored because of the limitations of     pharmacological therapy.      Auriculotherapy (AT) is one of the approaches in traditional Chinese medicine (TCM). It is a     therapeutic method by which specific points on the auricle are stimulated to treat various     disorders of the body. The present study is a four-arm randomised controlled study to     determine the effectiveness of AT using magneto-AT (MAT) and/or laser AT (LAT) to improve the     conditions of elderly patients suffering from OA knee. The effectiveness of MAT and LAT in     terms of alleviating pain, relieving stiffness and promoting a range of motion, and enhancing     functional abilities will be determined.      Subjects in 'Treatment arm 1' will receive MAT on specific auricular points on one side of     the ear during each treatment session. A deactivated laser will be used to achieve the effect     of subject blinding. Subjects in 'Treatment arm 2' will receive LAT using low-energy laser     applied to selected acupoints of the ear, and a plaster centred with a portion of Junci     Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will     receive a combined approach (both MAT and LAT). Subjects in the 'placebo arm' will serve as     placebo controls. Six auricular acupoints that are considered to have an effect on the OA     knee will be selected. Only one ear at a time will receive treatment. Thus, the ears will be     treated alternately. The total treatment period will be four weeks. The experimental objects     will be replaced every other day. Therefore, treatment will be performed thrice a week.     Subjects will be assessed at baseline up to 3 months after the therapy. This study could     advance the knowledge on the complementary approaches than can be used to improve OA knee     conditions in the elderly.   "
71290|NCT02352623|"     Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.   "
71291|NCT02352610|"     A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon     Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an     interference screw for thumb carpometacarpal arthritis   "
71292|NCT02352597|"     Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were     randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50     mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg     estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women)     received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.   "
71293|NCT02352584|"     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III   "
71294|NCT02352571|"     The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2     Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous     (IV) infusion to patients with stage IV solid tumors.      The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118     and explore prognostic biomarkers and pharmacodynamic biomarkers.   "
71295|NCT02352558|"     This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to     patients with relapsed, refractory hematologic malignancies, including multiple myeloma,     lymphoma, and others.   "
71296|NCT02352545|"     Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology     and wide-ranging. Cough is usually divided into three categories by time: acute cough,     subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main     etiology is postinfectious cough, which is mostly secondary to viral infection.Considering     its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in     gathering eosinophils to respiratory. The level of FENO has a significant correlation with     inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may     increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway     inflammation and decrease airway high activity by suppressing the biological activity of     CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the     course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO     can be used as a biomarker to optimized treatment regimen of sub-acute cough.   "
72151|NCT02341339|"     Prospective Feasibility Study:      Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during     their surgical evaluation of infertility. Of note, these patients are already scheduled to     undergo surgery as part of their standard of care.   "
71297|NCT02352532|"     The focus of this project is to evaluate the diagnostic utility of Shear Wave Elastography     (SWE) in individuals after routine low back injury and begin an initial investigation of it's     ability to effectively guide physical therapy treatment with dry-needling as a relevant     treatment intervention.      Specific Aim #1: Evaluate the diagnostic utility of SWE in differentiating individuals with     and without LBP. The investigators will also examine the interaction between tissue change     and clinical improvement. The investigators hypothesize that individuals with LBP will have     higher muscle stiffness (shear modulus) at rest and impaired (lower) stiffness during     contraction than individuals without LBP.      Specific Aim #2: Evaluate the effectiveness of dry-needling in decreasing aberrant muscle     stiffness in individuals with LBP. The investigators hypothesize that individuals with LBP     that receive dry-needling will exhibit larger changes than both individuals with LBP that     receive sham dry-needling and than individuals without LBP that receive dry-needling.      Specific Aim #3: Evaluate the effectiveness of dry-needling in decreasing pain and disability     in individuals with LBP. The investigators hypothesize that individuals with LBP that receive     dry-needling will exhibit larger improvements than individuals with LBP that receive sham     dry-needling.   "
71298|NCT02352519|"     In this research study, the investigators are trying to find out which of the two methods of     injecting local anesthetics (at the site of the belly button cut or by ultrasound guided     rectus sheath block) will provide better pain relief and less need for pain medication after     surgery in children undergoing single incision laparoscopic appendectomy.   "
71299|NCT02352506|"     Acute kidney injury (AKI) is a common complication in critical care patients. Currently no     parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor     (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate     the time course of MIF concentrations in patients with AKI.   "
71300|NCT02352493|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH   "
71301|NCT02352480|"     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a     prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated     using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as     provided in up to 100 U.S. wound centers   "
71302|NCT02352467|"     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a     prospective, open-label, randomized trial in which pressure ulcers will be treated using     Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary     Care.   "
71303|NCT02352454|"     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a     prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated     using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)   "
71311|NCT02352337|"     The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is     note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease     with the survival median of 2-4 months without chemotherapy.      Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until,     the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with     gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months     with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities     of this treatment are hematological, gastrointestinal and neuropathy with apparition of     sensitive neuropathy, reversible, related to oxaliplatin.      These results are on a population under 76 years old. In this study, the median age of     patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more     than 65 years old. Given the increase of proportion of patients than more of 65 years old     with pancreatic cancer and given the increase of life expected, it is important to know the     effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.      FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4     cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance     known between this 2 treatments witch limit toxicities and preserve quality of life of     patients. A Phase II trial testing this treatment regimen to classical regimen of     gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall     survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of     progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this     strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of     treatment.      The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8     cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without     decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference     regimen.   "
71304|NCT02352441|"     Many Service members (SM) experience executive dysfunction associated with mild traumatic     brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation.     Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy     instruction (MSI) to help patients self-regulate their behavior though a goal management     process - identifying a goal, anticipating performance problems, generating possible     solutions, self-monitoring performance during the activity, recognizing maladaptive task     strategies, stopping and then modifying real-time task behavior by choosing an alternate     strategy. MSI alone often does not result in improved daily functioning because it requires     conscious cognitive oversight to employ (which is difficult for people with executive     dysfunction) and it presumes that simply establishing goals propels goal-directed action,     when for many people, this is not so. Social psychologists report that people who set     implementation intentions (if-then statements that link specific situational cues with     specific goal actions) are more likely to perform goal actions than those who only set goal     intentions. Implementation intentions are believed to be effective because they enable people     to switch from conscious-effortful reflective action control to automatic, reflexive action     control associated with selected situational cues. A team of researchers from the Courage     Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC),     and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM     with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of     IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the     practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION     sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and     performance on a task that challenges executive function using a small randomized controlled     trial. If the results are positive, a larger study would be conducted to determine the impact     of ACTION sequence training on SM performance on military-relevant tasks and goals.   "
71305|NCT02352428|"     The overall aim of this population-based screening study is to assess whether the skin cancer     screening training of family physicians and dermatologists leads to improved screening     outcomes. The training course aims to increase the accuracy of detecting early stages of skin     cancer. Screening outcomes of an intervention region (Calgary, Canada) in which physicians     receive training will be compared with screening outcomes of a control region (Edmonton,     Canada) where no physician training is administered.      The investigators will determine whether:        -  clinical screening outcomes are more favorable in the group of trained physicians          compared to non trained physicians        -  there is an increase of knowledge about skin cancer screening among trained physicians,          compared to non trained physicians        -  skin cancer screenings are associated with psycho-social harms        -  population-based screening has an effect on the overall incidence and          stage-specific-incidence of skin cancer in Alberta      The investigators are aiming to recruit 100 physicians per region (total of 200 physicians)     who will screen 40,000 to 80,000 individuals over a period of 20 months.   "
71306|NCT02352402|"     In the POPular CABG study we investigate if the addition of ticagrelor, a drug that inhibits     blood platelets from clotting, to treatment with aspirin will reduce the rate of saphenous     vein graft occlusion as assessed with coronary computed tomography angiography at 1 year     after coronary artery bypass grafting surgery.   "
71317|NCT02352259|"     The study is prospective, phase II study, The primary objective of the study is evaluation of     the feasibility and safety of intraoperative electrochemotherapy of colorectal liver     metastases. The secondary objective is to determine the efficacy of electrochemotherapy     treatment, based on histological and radiological evaluation of treated metastases. The     endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events     (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST     criteria.   "
71360|NCT02351700|"     A randomized, double-blind, placebo-controlled intervention trial involving 100 treated     subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects     will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in     the standard post-operative medication arm.   "
71307|NCT02352389|"     The purpose of the proposed study is to gather critical information that may be useful in     designing effective prevention and treatment strategies for control of seasonal influenza and     an influenza pandemic. In particular, the critical questions are related to the virus'     ability to adapt to efficient replication and spread in humans.      Influenza is a contagious respiratory illness caused by influenza A and B viruses. Influenza     infections result in about 230,000 hospitalizations and 36,000 deaths annually in the United     States. Children with cancer are more likely to have serious influenza and complications than     those who have no underlying medical problems. They are also more likely to have prolonged     influenza illnesses and to shed influenza viruses from their noses for long periods of time     (sometimes for months). Recent studies suggest that influenza viruses may also be carried and     shed from the gastrointestinal tract. New types of influenza viruses emerge frequently     through mutations that occur when the viruses replicate. These mutations allow the virus to     escape from killing by the immune system and are, in large part, responsible for seasonal     epidemics of influenza that occur in the fall or winter months. It is possible that viruses     can mutate when they are carried in the respiratory or gastrointestinal tracts for long     periods, potentially giving rise to viruses that spread more easily to other persons, cause     more severe disease, lead to new influenza epidemics or make the viruses resistant to drugs     used to treat influenza.      Researchers at St. Jude Children's Research Hospital want to learn about how influenza     viruses mutate in immunocompromised children. They will investigate how long children with     cancer carry influenza viruses in their nose, throat and gastrointestinal tract and the     characteristics of any mutations that are found in these viruses.   "
71308|NCT02352376|"     This is a prospective, quantitative, randomized, crossover study. Were included in this study     10 people in the Intensive Care Unit at University Hospital in Uberlandia, on the first day     of the postoperative coronary artery bypass graft (CABG). For data collection was performed     randomization on the block (2: 4), to determine the first technique to be used and then a     wash-out period of one hour was allowed for the research subject reaches the systemic     arterial pressure, heart rate, respiratory rate and oxygen saturation baseline. And after,     for cross-over, the second technique was performed. Non-invasive ventilation was performed     for 30 minutes each ventilator. All subjects underwent noninvasive ventilation using two     models of ventilators, they are conventional (designed for invasive ventilation but is also     used in non-invasive ventilation mode) and specific (designed for non-invasive ventilation).     Hemodynamic, autonomic and respiratory variables are monitored. We use the hypothesis that     non-invasive ventilation performed with two fan models can alter autonomic function and that     there is hemodynamic changes related to autonomic function in different ventilators in     postoperative coronary artery bypass grafting.   "
71309|NCT02352363|"     This study is a 12-month, open-label, randomized, multicenter study which will evaluate the     safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in     Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will     include a concurrent observational cohort of PD patients managed using the usual standards of     care.   "
71310|NCT02352350|"     Blood lactate levels will be measured using a simple handheld device at time of return of     spontaneous circulation (ROSC) following out of hospital cardiac arrest (OHCA). Patient     outcomes tracked will include rate of survival to hospital discharge, rate of 6 month     survival, and neurological status. The hypothesis for this pre-hospital study is to confirm     the previous in-hospital findings that very high blood lactate after ROSC is associated with     very high mortality and severe neurological impairment.   "
71314|NCT02352298|"     The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor     (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals     and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings     to readings obtained from the YSI 2300 STAT Plus glucose analyzer.   "
71315|NCT02352285|"     The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na     levels in patients with worsening heart failure and hyponatremia.   "
71316|NCT02352272|"     Objectives: investigate the effects of 6 nights of sleep extension on physical and cognitive     performances before, during total sleep deprivation (39 hours continuous awaking) and after a     subsequent recovery sleep.      Design: Subjects participated in two experimental conditions (randomized cross-over design):     extended sleep (10-h in bed, EXT) and habitual sleep (8-h in bed, HAB). In each condition,     subjects performed two consecutive phases: (1) six nights of either EXT or HAB (2) three     experiments days in-laboratory:baseline (BASE), sleep deprivation (TSD) and after 10 h of     recovery sleep(REC). Performance tests were administered every 3 hours over the 3-d in     laboratory.      Setting: This cross-over and randomized study was conducted under standardized laboratory     conditions with continuous polysomnographic recording Participants: 14 healthy men (age     range: 26-37 years) participated in the study.      Interventions: EXT vs. HAB sleep durations prior to total sleep deprivation (39 hr continuous     awaking).   "
71421|NCT02350907|"     The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR     test to detect the organism N. gonorrhoeae and its most important genetic markers of     antimicrobial resistance. This study will also determine factors associated with gonorrhoea     and describe sexual behaviours of men who have sex with men, to inform parameters for a     mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.   "
71318|NCT02352246|"     Postmenopausal women, as men, are more prone to central or android obesity. Abdominal fat     mass is associated with an increase of cardiovascular diseases (CVD). In type 2 diabetic     (T2D) patients, the risk of CVD mortality is more than double compared with that in     age-matched subjects.      Most exercise programs designed for weight loss have focused on steady-state exercise (SEE)     of around 30 min at a moderate intensity several times a week. Disappointingly, these kinds     of exercise programs have led to little or no fat loss (Shaw et al. 2006). Accumulating     evidence suggests that high intensity intermittent exercise (HIIE) has the potential to be an     effective exercise protocol for reducing fat of overweight individuals, especially at the     abdominal level (Boutcher 2011, Kessler 2012). Despite these results, HIIE program has never     been used in TD2 postmenopausal women to favor a specific decrease of abdominal fat mass.      The aim of our study was to compare the effects of 16-week steady-state exercise (SSE)     program with high intensity intermittent exercise (HIIE) program on total abdominal and     visceral fat mass in T2D postmenopausal women.      It is hypothesized that HIIE compared to SSE program would result in significantly greater     reductions in total abdominal and visceral fat mass.   "
71319|NCT02352233|"     Colonoscopy is the gold standard technique for diagnosis and treatment of colonic lesions.     Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown     better results regarding adenoma and polyps detection when compared to standard non HD     scopes. However, evidence shows that during standard colonoscopy many lesions could be     missed, including polyps, cancer and other kind of lesions. This could be correlated to many     factors and recently reports show evidence that lesions behind the folds could be missed     because the limitation of a forward view examination. Until know, a new auxiliary imaging     device called Third Eye Retroscope had demonstrated more lesions detection during     colonoscopy using a retro view, but with some limitations as absence of HD vision, the need     of additional equipment and the fact the device occupies the accessory channel, limiting     therapeutic efficiency. Recently a new HD colonoscope called RETROVIEW (PENTAX Medical) has     been developed. It permits visualization of colonic mucosa in forward view, in retroflex view     and allows for performance of diagnostic and therapeutics in a single colonoscope.   "
71320|NCT02352220|"     COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in     the patient's quality of life, high prevalence, growing incidence and socioeconomic     implication. COPD natural history and first stages determinants are unknown. Knowing them     will help to understand the natural history of the disease and to design interventions that     can modify the prognosis of the disease.      Study objectives: (1) To characterize an early COPD population from a multidimensional point     of view including demographic, social, family and clinical data, lung function, exercise     capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and     sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung     function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in     the future to understand the complete natural history of the disease.      Methods: Design: multicenter cross-sectional study that will allow establishing a     well-characterized cohort of early COPD patients for later follow-up. Recruitment will be     done in Primary Care settings. Subjects: smokers (> 10 packs year) between 35-50 years old     with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be     based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in     the first second) / FVC(Forced Vital Capacity) < 70%. Age, sex and site matched 'healthy'     smoker controls will be compared with the COPD cases. Variables that will be collected in the     reference hospitals are: health questionnaires, lung function test, exercise capacity, blood     and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's     characteristics will be described and then, will be compared, with control subjects through a     conditional multiple logistic regression analysis.   "
71321|NCT02352207|"     This research focuses on lung malformations detected in fetuses during prenatal ultrasound     exams. Pathogenic mechanisms of these rare malformations are poorly understood. Improved     knowledge is needed, to give families better information, and to better standardize treatment     decisions The main goal is to better predict neonatal complications associated with these     malformations, by identifying key predictive markers during the fetal period.      To achieve this objective, it is planned to include 400 pregnant women with prenatal     diagnosis of pulmonary malformation in 45 health centers in France. This is the largest study     on this topic at the international level.   "
71322|NCT02352194|"     The purpose of this study is to assess the physical capacity of patients with multiple     sclerosis and the effects of rehabilitation, encompassing physical therapy and physical     activity as it is carried out in the day hospital of (the Physical and Rehabilitation     Medicine department) at Garches Hospital. We will compare the results of assessments carried     out before and after a standard rehabilitation program.   "
72243|NCT02340130|"     This is an open-label, non-controlled, non-randomised, prospective safety study in patients     with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically     relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.   "
71323|NCT02352181|"     In current practice, management of coagulation during liver transplantation is performed     either through standard coagulation status or with ROTEM® depending on practitioner choice     and availability of materials. In this context, the ROTEM® is used since over 2 years by     anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon,     France.      Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy     developed by patients who are eligible, due to coagulation factor synthesis deficiencies in     the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection     of coagulopathy in such patients because the imbalance between pro- and anti-coagulant     factors are not taken into account by PT and aPTT measures. Management of intraoperative     hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which     allows the detection of abnormalities in the balance between pro- and anti-coagulant factors.      This technique was already evaluated in liver, cardiac, and obstetric surgery but also in     traumatology. Randomized trials in liver transplantation surgery have shown changes in     transfusion practices but did not focus on the consequences of such changes.   "
71324|NCT02352168|"     The purpose of this study is to determine whether treating upper airway with intranasal     corticosteroids in children with allergic rhinitis and no asthma may bring favors in reducing     lower airway inflammation and improving small airway function.   "
71334|NCT02352038|"     The aim of the study is to assess the effects of low-level laser therapy (LLLT) in patients     with periodontitis during orthodontic-periodontal treatment for 12 months on the following     aspects: (1) Effects on periodontal status; (2) Effects on alveolar bone remodeling; (3)     Effects on cervical dentin sensitivity; (4) Effects on pain and quality of life.      To eliminate any bias, the investigators will initially hypothesize that there is no     difference in periodontal status, jawbone remodeling, tooth sensitivity, pain and quality of     life in patients having teeth with chronic periodontitis and receiving LLLT with orthodontic     treatment versus teeth undergoing orthodontic treatment without incorporation of LLLT.   "
71325|NCT02352155|"     Bleeding peptic ulcer is a common medical emergency. Endoscopic treatment stops bleeding in     those actively bleeding from their peptic ulcers, reduces further bleeding, transfusion,     surgery and deaths. After initial endoscopic control of bleeding, approximately 10% of them     will develop recurrent bleeding. Mortality rate in this group of patients is at least 4 fold     higher. In the few who need surgery, mortality approaches 30%. Prevention of further bleeding     is therefore a major treatment objective. Currently the investigators use a high dose     infusion of proton pump inhibitor (PPI) for 72 hours to render gastric pH neutral. In a     previous randomized trial, the investigators showed that the rate of bleeding in 30 days was     around 7% with such an approach. In a small subgroup of high risk patients defined by     presentation with shock and ulcers > 2 cm in size, 1 in 6 would re-bleed. An alternate     strategy is to select those at especially high risk of further bleeding and repeat endoscopic     treatment the next morning. The investigators have shown that persistence of major bleeding     stigmata, i.e. a visible vessel, during a second endoscopy predicts further bleeding. It is     therefore logical that by repeating endoscopic treatment the next morning, the investigators     can prevent further bleeding and possibly surgery and deaths. The current study proposes to     develop a score to identify those at risk of further bleeding after endoscopy. The     investigators used a historical cohort with carefully collected clinical data to derive a     risk score. In this derivation phase of 939 patients, the investigators have developed a 9     point risk score which consists of the following parameters (Age>60, Male sex, ulcer>2cm,     posterior bulbar in location, spurting or Forrest Ia bleeding and admission hemoglobin of < 8     g/dl). Using AUROC and Youden J statistics, a score of 5 or above has been shown to highly     predictive of further bleeding. The score will then be validated in a prospective cohort of     patients with bleeding peptic ulcers. In the final phase of this study, the investigators     propose a randomized controlled trial to test the hypothesis that a second look endoscopy     with treatment in selected high risk patients can further reduce bleeding and improve their     outcomes. After endoscopic hemostasis to their bleeding peptic ulcers, patients are risk     stratified based on the score. Those with a score of 5 or more are randomized to receive the     standard treatment (a high dose PPI infusion) or a second look endoscopy with treatment in     addition to PPI infusion. The primary outcome to the trial is further significant clinical     bleeding.   "
71326|NCT02352142|"     The purpose of this proposal is to conduct a replication study of Family Nurture Intervention     (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early     development. These include early and repeated mother/infant calming interactions during the     NICU stay, such as interactive touch with vocal soothing, sustained reciprocal olfactory     exposure and family practice in comforting, and systematically implemented skin to skin     holding. This has already been studied at CHONY. Findings reveal that infants who receive FNI     have significant increases in EEG power, a measure of brain activity, near to term age, when     compared with those who receive Standard Care.      There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot     subjects will be enrolled to train the staff involved in the procedures used in this     Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study     patients and will be encouraged to participate fully. They will not be included in the     analysis of the RCT.      The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION     group, in addition to the standard care, will receive the FNI intervention, which will be     facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be a     third non-randomized group of infants born at term age who will receive standard care for     newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG),     measures of maternal sensitivity through recorded mother-infant interactions and a variety of     specimen collections (saliva, blood, and breast milk samples). The investigators will be     conducting two follow up studies, at 4 months corrected age and at 12 months corrected age.     The investigators will test the immediate and long-term effects of this approach to the     development of preterm infants.      The investigators hypothesize that this intervention will alter a wide range of indices of     physiological regulatory capacities, and increase brain activity as measured by EEG (power     and coherence) such that a brain activation pattern in the intervention group will be more     similar to that of full term infants as opposed to the standard care group. Longer term     indices of mother psychological and infant neurobehavioral outcomes will also be improved     when assessed during the first few months of life.   "
71327|NCT02352129|"     : Fibrosis, in general, is a scarring process, which is characterized by fibroblast     accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to     distorted organ architecture and function. The contribution of fibrogenesis to impaired     cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and     induces pathological signaling within cardiomyocytes resulting in progressive cardiac     failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and     increases the risk of arrhythmias. But today patient treatment and prognosis is based on     ejection fraction quantification, QRS duration, and symptoms.      Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared     with normal value, is of prognostic value in patient with dilated cardiomyopathies under     optimal treatment.      Methods: 330 patients are planned to be included and followed for 2 years   "
71328|NCT02352116|"     This study aims to assess the differences in overall pain severity, pain management, and     satisfaction during recovery period between two groups of children who either receive or do     not receive additional education related to expectation and management of postoperative pain.   "
71329|NCT02352103|"     To assess and compare the short-term post-operative continence recovery rate in two cohorts     of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo     RARP with Vattikuti Institute technique or Retzius sparing technique.   "
71530|NCT02349477|"     This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol     dependence will get medication, which might help them to reduce or stop their drinking, or a     placebo ( placebo is a capsule that looks the same as the investigational drug, but has no     real medication. It is a sugar pill).   "
71330|NCT02352090|"     The main objective of the study is to compare the metabolic effects of natural estradiol and     synthetic ethinylestradiol used in combined oral contraception in healthy women. A     progestin-only preparation will be used in comparison. The main goal is to study the effects     on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP).     Our hypothesis is that the natural estradiol preparation will influence blood glucose levels,     markers of coagulation and chronic inflammation less than the ethinylestradiol preparation.     The progestin-only preparation will not effect these parameters.   "
71331|NCT02352077|"     The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with     bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with     chronic spinal cord injury.   "
71332|NCT02352064|"     Allogeneic stem cell transplantation was developed to cure many patients with hematological     malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of     cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver,     gastrointestinal tract) and / or the observation of typical clinical signs sufficient for     diagnosis. However, the anatomical sites for biopsy including the digestive tract are not     clearly identified (high or low biopsy) and may present risks in their realization in     particular in patients weakened by blood disease or immunosuppression.      PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as     Crohns disease with good sensitivity and specificity. It interest in the graft against the     host was studied in acute forms of digestive and allows lesion mapping and monitoring the     effectiveness of treatment.      Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view     musculoskeletal uptakes localized to the affected areas identified with MRI.      The investigators propose a study evaluating the sensitivity and specificity of the     examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional     diagnostic tools.   "
71333|NCT02352051|"     The aim of this study was to evaluate and compare the effects of Atomoxetine(ATX) and osmotic     release oral system-methylphenidate (OROS-MPH) therapies on executive functions, activities,     treatment response time and adverse effects based on discernible clinical effects in children     with combined type attention deficit-hyperactivity disorder (ADHD).   "
72161|NCT02341209|"     This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell     Lymphomas.   "
71338|NCT02351986|"     Background: Subacromial impingement syndrome (SIS) is a chronic and disabling disease,     characterized by compression and mechanical abrasion of the tendons of the rotator cuff     muscles, subacromial bursa and tendon of the long head of the biceps against the anterior     surface of the acromion, coracoacromial ligament or the acromioclavicular joint during arm     elevation movement. After the trauma, inflammatory processes initiate and may lead to loss of     function when untreated. This inflammation leads the release of cytokines (IL-6, IL-10, IL-1β     and TNF-α) whose acts as inflammatory mediators. Physical therapy works in treating SIS with     the goal of reducing pain and inflammatory process. Cryotherapy is widely used in physical     therapy by anti-inflammatory and analgesic effects, low cost, effectiveness and easy     application. Objective: The aim of the study is to evaluate the effects of a cryotherapy     protocol, applied on shoulder of subjects with SIS, on serum inflammatory mediators     (cytokines) and local pressure pain threshold. Possible changes in function and pain will     also be evaluated. Materials and Methods: 30 subjects will be selected and share in two     groups, 15 healthy subjects and 15 subjects with SIS. Function assessments and quality of     life will be held using the DASH and WORC questionnaires. Cryotherapy will be applied for 4     consecutive days, lasting 20 minutes without interruption through ice pack over the shoulder     of SIS carriers. For the blood samples, 20ml of blood will be collected at the first and last     day of the intervention, and then stored at -80 ° C.   "
71339|NCT02351973|"     The purpose of this study is to determine whether the routine combination of optimal thiazide     and K+-sparing diuretic will both increase efficacy of BP reduction and reduce risk of     glucose intolerance; and whether K+-sparing diuretics alone may have a neutral or even     beneficial effect upon glucose tolerance.   "
71340|NCT02351960|"     The purpose of this study is to evaluate the effectiveness of symptom control in     gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.   "
71341|NCT02351947|"     The purpose of this research study is to improve methods for evaluation of brain changes     during motor learning for patients with stroke, who have difficulty performing daily tasks     with their arm and hand. The methods for evaluation of brain changes will consist of the     combination of magnetic resonance imaging (MRI) and electroencephalography (EEG).   "
71342|NCT02351934|"     The purpose of this study is to find out if giving a medicine called furosemide, which is a     diuretic or water pill, after colon surgery will safely shorten the patient's length of     hospital stay.   "
71343|NCT02351921|"     This study will investigate how repetitive transcranial magnetic stimulation delivered as a     protocol called 'continuous theta-burst stimulation (cTBS)' alters motor output and force     control to a muscle in the forearm and touch perception in individuals with chronic,     incomplete spinal cord injury. CTBS is a non-invasive technique that involved repetitive     delivery of transcranial magnetic stimulation at a frequency of 30 Hz over the arm     representation in the primary motor or sensory cortex. The purpose of this study is to     determine whether cTBS is an effective intervention to increase motor output to a muscle and     increase force control of that muscle and also improve the sense of touch.   "
71344|NCT02351908|"     The purpose of this study is to observe the safety of Truvada® (TDF/FTC) in relation to its     impact on kidney function combined with different Integrase Inhibitors (Dolutegravir, or     Elvitegravir/Cobicistat or Raltegravir), when given to patients who are commencing treatment     for HIV infection for the first time.      All three combinations (Raltegravir + Truvada®, Dolutegravir + Truvada® and Stribild®, a     single pill which contains Elvitegravir/Cobicistat/Truvada®) are currently recommended by the     national guide-lines and used in standard clinical practice.   "
71345|NCT02351895|"     This is a prospective Infection Control study comparing rates of antibiotic usage and     infections in the General Intensive Care Unit (GICU) in beds with copper impregnated linens     versus regular linens.   "
71531|NCT02349464|"     The purpose of this study is to determine whether a post-hospital discharge lactation support     system increases preterm infant intake of mother's milk.   "
71346|NCT02351882|"     Alzheimer's disease (AD) is commonly associated with behavioural changes such as agitation.     Severe agitation is important to treat because it not only increases progression of AD and     physical health problems (increased falls and weight loss), but it also decreases quality of     life and increases caregiver stress. Currently prescribed treatments (i.e., antipsychotics)     for agitation in AD do not work in everybody and when they do work the effect is small and     they increase the risk of harmful side effects, including death. As a result, there is an     urgent need for safer medication options. The cannabinoid nabilone can now be prescribed in     capsule form for appetite and pain killing effects. Nabilone's calming effects may benefit     those with agitation, and help the weight loss and untreated pain frequently associated with     agitation. Through a clinical trial, the investigators hope identify the benefits of nabilone     in the treatment of agitation in AD.      The investigators objective is to determine whether nabilone is an efficacious and safe     treatment for agitation, as well as having benefits for pain, weight and behavioural     symptoms. This will be a 14 week clinical trial (participants take nabilone for 6 weeks,     placebo for 6 weeks (order randomized) with 1 week between treatments). The investigators     will assess and compare agitation, weight, pain, memory, behaviour and safety.      Nabilone is a new class of medication that may be a safe and effective treatment for     agitation in AD, with added benefits on appetite and pain. Reducing these symptoms would     increase quality-of-life and reduce caregiver stress.   "
71361|NCT02351687|"     Children who recover from moderate acute malnutrition in Malawi remain at high risk for     relapse or death in the year following recovery. This cluster-randomized trial will evaluate     a package of affordable, safe, proven interventions specifically targeted to this population     of children in an attempt to decrease their risk of relapse or death following recovery from     moderate acute malnutrition. These children will be followed for a year following recovery to     assess rates of relapse and mortality.   "
71362|NCT02351674|"     The trial is a single centre, retrospective cohort, non-interventional study to be conducted     in the department of cardiology, Chinese PLA General Hospital, Beijing, China. To evaluate     the link between mean perioperative clinical heart rate and short-term composite outcomes     during PCI among local CHD patients.   "
71363|NCT02351661|"     The Nutrition Care In Canadian Hospitals study, conducted by the Canadian Malnutrition Task     Force had the primary purpose of determining the prevalence of malnutrition in Canadian acute     care hospitals. Secondary objectives were to determine the independent association of     malnutrition with patient centred outcomes (e.g. length of stay) and describe the nutrition     care processes for malnourished and well nourished patients.   "
71347|NCT02351869|"     This study is a 7-day randomized, double-blind proof-of-concept pilot study of nitrous oxide     vs. midazolam in 40 adults (20-60 years) with bipolar disorder (BD) (type I or II). Ongoing     pharmacological and psychosocial treatments may continue, provided that they have not been     initiated or significantly modified in the preceding 2 weeks. Participants' current treatment     as prescribed by clinical psychiatrists will not be modified or interfered in this study. The     study involves 3 visits. During study visit 1, participants will complete screening to ensure     study eligibility. This will be done using interview measures. During study visit 2,     participants will complete anthropomorphic measurements, measurement of endothelial function,     screening blood work, ECGs, and an anaesthesia screener. During study visit 3, participants     will receive the treatment (nitrous oxide or midazolam), complete an MRI scan, and complete     interview measures and self-reports. There will be anthropomorphic measurements taken as     well. The participant will be required to complete phone interviews and self-reports over the     subsequent 7 days. There are 4 main predictions: 1. Nitrous oxide will significantly reduce     depression symptoms vs. midazolam. 2. Nitrous oxide will significantly increase frontal     cortical perfusion vs. midazolam. 3. Lower perfusion in frontal cortical regions at baseline     will be associated with greater improvement in depression symptoms following nitrous oxide     treatment. 4. Poorer endothelial function will be associated with greater improvement in     depression symptoms following nitrous oxide treatment.   "
71348|NCT02351856|"     This is a rollover study designed to investigate the safety and effectiveness of     investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a     study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and     may, in the Investigator's opinion, derive benefit from continued treatment.   "
71349|NCT02351843|"     The purpose of this study is to demonstrate the clinical feasibility of low amplitude     electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by     lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low     amplitude ECT could potentially reduce the risks associated with ECT while preserving its     unparalleled efficacy. This novel development would remove key obstacles to allow for the     wider adoption of ECT as a safe and effective therapy.   "
71350|NCT02351830|"     The EEU has proven effective in multiple studies evaluating various aspects of seasonal     allergic rhinitis. All previous EEU clinical trials have utilized ragweed or grass pollen as     the allergen of choice for dispersal, due to the local population, but many emerging     treatments for allergic rhinitis are allergen specific, thus it is desirable to expand the     repertoire of pollen selection for use in the EEU. Ragweed, grass and birch pollen have     differing appearances and sizes but essentially, both have characteristics which promote the     ability to keep the pollen grains suspended and hence, the ability to maintain proper     concentrations within the EEU. Preliminary validation studies conducted in the EEU, absent of     human volunteers, have confirmed our ability to release, disperse and maintain birch pollen     concentrations in the EEU using the existing technology.      This study aims to validate the use of birch pollen on a clinical scale. By adding non-     allergic participants into the EEU, the investigators hope to determine if non-allergic     persons exhibit differences at baseline in their epigenetic biomarkers from those who have     pre-existing and established allergic airways inflammation.   "
71351|NCT02351817|"     The primary objective of the investigation is to explore the acceptance of a newly developed     adhesive.   "
71352|NCT02351804|"     The purpose of this study is to investigate whether dexamethasone as an adjuvant to     ropivacaine for adductor canal block increases duration of the sensory block, when     controlling for a systemic effect using a paired design and bilateral blocks.      The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block     duration compared with ropivacaine + placebo.   "
71354|NCT02351778|"     In study the investigators sought to        1. Assess the quality of life experience in stable post stroke survivors in Pakistan and          detail important factors influencing quality of life.        2. Explore the association between primary care giver`s quality of life and stroke          survivor's quality of life.        3. To validate the quality of life tools and experience via in depth interviews and focus          group discussion with the primary care giver of stroke patients to report the quality of          life of the primary care giver.   "
71355|NCT02351765|"     The purpose of this study is to determine the recommended phase II dose, and to assess the     safety of acelarin in combination with cisplatin in patients with locally advanced/     metastatic biliary tract cancers.   "
71356|NCT02351752|"     IgA nephropathy is the most common type of primary glomerulonephritis and might caused by     deposition of immune complex containing IgA in mesangium and causing local immune activation.     Hydroxychloroquine reduces the activation of dendritic cells and the inflammatory process and     showed the potential effect of treatment of patients with IgA nephropathy.      The investigators study will recruite IgA nephropathy patients with proteinuria range from     0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were     treated with Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded     every two months and total four months. Then, the drug will be stopped for two months for     observation of change of proteinuria.   "
71357|NCT02351739|"     Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant     Metastatic Urothelial Cancer   "
71358|NCT02351726|"     Prospective, non-randomized, multicenter post-approval study to collect long term clinical     and echographic data on Mitroflow DL patients.   "
71359|NCT02351713|"     Therefore, the purpose of this study is to compare the effectiveness of two exercise training     programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e.,     threshold based training) versus the more common ACSM recommended relative percent method     (i.e., %HRR).      It is hypothesized that:        1. The ACE three-zone training model will elicit greater mean changes in cardiorespiratory          fitness (as measured by VO2max) when compared to the relative percent method.        2. Participants in the ACE three-zone training model group will be more likely to have          favorable VO2max responses; while comparatively, participants in the relative percent          method group would be more likely to experience a VO2max nonresponse to exercise          training.   "
71365|NCT02351635|"     The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™     ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD;     Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel     Syndrome (IBS).      To estimate the predictive value of a positive test (positive predictive value (PPV)) and the     predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test     outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic     evaluation with signs and symptoms suggestive of either IBS or IBD.      To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.      To provide exploratory observations of test results in patients between the age of 2 and 21     years.      To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal     disease for use in Expected Value Testing.   "
71366|NCT02351622|"     The investigators are undertaking a multicentre, randomised controlled trial of 120 adults     with newly diagnosed ITP from 5 medical centers in China. Part of the participants are     randomly selected to receive caffeic acid tablets combining dexamethasone and the other part     are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other     symptoms were evaluated before and after treatment. Adverse events are also recorded     throughout the study.   "
71367|NCT02351609|"     Cigarette smoking is a significant health threat. To eliminate disparities in cancer burden,     smoking rates must be reduced among populations where smoking is disproportionately     concentrated: those with low socioeconomic status (SES). The investigators will apply two     methods that are being used in the field of health disparities to the challenge of promoting     smoking cessation among low SES smokers. These include: 1) Patient navigation; patient     navigators are often lay persons, working as paid employees, who guide patients through the     health care system and 2) Financial incentives; investigators propose to provide monetary     incentives: $250 for smoking cessation within 6 months after study enrollment, and $500 for     an additional 6 months of abstinence after the initial cessation. The investigators will     recruit/randomize 352 smokers to a randomized controlled trial comparing the combination of     Patient Navigation (delivered over 6 months) and Financial Incentives versus Enhanced     Traditional Care control condition (smoking cessation brochure/list of cessation resources).     The RCT will take place among adult daily smokers seen in the past year at BMC primary care     practices, with a primary outcome of smoking cessation at one year. Follow-up by telephone,     for both groups, will occur 6, 12, and 18 months after enrollment.   "
71368|NCT02351596|"     This study aims to determine if participation in a core stability physiotherapy group     programme can improve the balance of children with cerebral palsy. It is hypothesised that     teaching the children how and when to activate their deep core stabilising muscles may help     improve their body awareness and their ability to control their alignment and therefore     positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who     can walk independently, will be randomly selected to join either the control group or     intervention group, after completion of their baseline balance assessments. Each group will     be re-assessed after completion of their 4 week intervention or control period.   "
71402|NCT02351154|"     Atrophic gastritis (AG) is a chronic disease, associated to gastric adenocarcinoma moreover     if severity AG is present. Sydney system classified AG as mild, moderate and severe, but with     moderate interobserver agreement, due to this system is based in a visual analogic scale     (qualitative analysis). Confocal endomicroscopy showed an accuracy of 98% for diagnosis     gastric diseases, but when grading AG still remains a qualitative measure. Recently, a new     software called Cellvizio® Viewer (CV) permits to measure in micrometers (µm) the     structures observed after confocal laser endomicroscopy probe studies. Based on the     hypothesis that AG severity is correlated with crypts size diminution, the aim of this study     is to determine a quantitative way to classify the severity of AG measuring the crypt area     and inter-crypt spaces in patients with AG.   "
71369|NCT02351583|"     Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major     cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation     with subsequent release of inflammatory mediators leading to a generalized endothelial     dysfunction. It is now accepted that endothelial dysfunction heralds the clinical     manifestations of preeclampsia.      The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth     region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black.     SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was     used before in many situations especially in sepsis and septic shock patients.      Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR)     light by tissues perfused with oxygenated blood, and is capable of measuring changes in     parenchymal volume tissues. It was used before in many situations (including pregnant     patients) to reflect the tissue oxygenations.      The investigators are planning to use the SDF and NIRS tools to study the microcirculatory     change in preeclamptic subjects and normal pregnant subjects. If these two devices are able     to determine any changes this should stand as a baseline for future studies in this field.   "
71370|NCT02351570|"     By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007     in §20 SGB V the health insurance schemes have received an enlarged action frame in the     primary prevention and the operational health support.      Through these paragraphs arises the possibility for citizens to let refund health-supporting     programmes or health training of the health insurance schemes.      Doctor's recommendation is one of the most important predictors by therapy decisions of     patients.      At the same time, primary prevention takes a very small part of the working hours of general     practitioners.      Hence, is the aim of the present study to examine whether and how general practitioners could     be incorporated in the mediation of prevention's offers.      To reach this aim, must be grasped first, to what extent general practitioners are already     integrated into in the mediation of the primary prevention courses. There is up to now no     information about whether general practitioners know about the GKV-improved prevention     programmes for GKV-insured person and whether they are involved in their mediation. This     research project will close this gap.      The aims of the study are:        1. to explore the roll of primary prevention in the general practitioner's consultation        2. to analyse which social institutions are responsible for primary prevention according to          the general practitioner's opinion        3. to explore which primary prevention's programmes do general practitioners in their          consultation recommend        4. to analyse which factors play a role in the mediation        5. to explore whether general practitioners with §20 are familiar.      This is a mixed methods study which combines a mail survey of all general practitioners in     Berlin with focus groups of 25 general practitioners.      In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for     the focus groups are invited from the pool of teaching doctors of the Institute for General     Medicine at the Charite.      After both methods are analyzed on their own, the triangulation of the interpretation of both     data sets will be done to find possible answers of the study questions. Bi-directionality of     results will contribute to find possible interpretations of the survey responses in the     results of the focus group discussions, as well as the results of the focus groups     discussions could be explained by the results of the survey (Flick).   "
71371|NCT02351557|"     This study examines the effect of blood flow through the lungs and the body on the     consumption and hence requirement of the anesthetic agent isoflurane.   "
71372|NCT02351544|"     According to the peripheral trigger theory of migraine headaches, nociceptive inputs from     irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain     that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral     trigger points can be administered to patients who have failed medical management of     migraines. Those accepted advanced treatments include botulinum toxin A injection in order to     temporarily paralyze muscles causing nerve compression, and surgery to release those     compression points permanently. An advantage of surgery is the ability to release     non-muscular causes of nerve compression, such as fascial bands or intersecting arteries.      Botulinum toxin A injection into trigger sites has been shown in multiple studies to be     effective at reducing the frequency and severity of migraine headaches, and is a very     commonly administered treatment for refractory migraines. It is approved by the FDA for the     treatment of chronic migraines.      Similarly, surgical decompression of trigger sites has previously been shown to have superior     clinical outcomes to medical management, through a randomized, blinded controlled-trial     performed at Case Western Reserve in 2009. Patients either received actual decompression of     the trigger sites, or sham surgery (exposure and visualization of the trigger sites, without     decompression). At one-year follow-up, the group who underwent actual surgery demonstrated a     statistically higher proportion with significant improvement in their migraines (83.7% vs.     57.7%, p=0.014), and with complete elimination of their migraines (57.1% vs. 3.8%, p<0.001).     Several other reports have confirmed the good clinical outcomes of surgery demonstrated in     this trial, and surgical decompression is now commonly performed by several surgeons around     the United States.      Prognostic factors predicting the success of surgical decompression in migraine headache     treatment include older age of migraine onset, visual symptoms/aura, and 4-site     decompression. Factors predicting failure of surgery include excessive operative blood loss,     and surgery on only one or two trigger sites.      One criticism of the studies on peripheral trigger decompression surgery for migraines has     been that most of the results have originated from the same institution (Case Western     Reserve), and from the same author (Guyuron). While several studies at other institutions     have demonstrated positive outcomes of peripheral trigger decompression, these have only     included a small number of patients.      In addition, the sham surgery randomized-controlled trial has been criticized for not     clarifying any prior treatments that patients had undergone before peripheral trigger     deactivation, and for not showing how medication use patterns changed after surgery. Another     criticism of that study was the fact that patients were examined by neurologists before the     study but not after the study, and that surgery was performed on some patients with episodic     migraines, who are known to not benefit from botulinum toxin. It is unclear what migraine     types are most likely to benefit from surgical decompression.      The investigators' goal is to perform a multi-center, prospective trial to demonstrate the     effectiveness of peripheral trigger decompression in the treatment of migraine headaches,     which would address the criticisms mentioned above. The main aim is to demonstrate that the     positive results demonstrated by Guyuron et al are reproducible at other institutions and by     other surgeons using similar techniques on different patient populations.   "
71373|NCT02351531|"     The aim of the study is to assess the hypoallergenicity of a new thickened extensively     hydrolyzed formula.   "
71422|NCT02350894|"     This study examines the possible microstructural changes in the brain during recovery after     mTBI using diffusion MRI.   "
71685|NCT02347449|"     The main goal of this study is to characterize whether the results of the Oncotype DX® assay     affect the physician's treatment recommendations for the adjuvant treatment of women with     ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential     candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.   "
71374|NCT02351518|"     Traumatic brain injury (TBI) affects 1.5 million patients per year in the United States,     resulting in more than 50,000 deaths and more than 230,000 hospitalizations annually.     Approximately 90,000 of these patients will suffer permanent impairment and more than half     will experience short-term disability.      Secondary injury processes play a critical role in the development of ischemia after trauma     to the central nervous system and occur hours-to-days after the primary insult. Ischemia can     lead to cerebral infarction or stroke. Ischemia has been described as the single most     important secondary insult and has been identified histologically in approximately 90% of     patients who die following closed head injury. Several factors resulting in post-traumatic     cerebral ischemia have been identified: increased intracranial pressure (ICP), systemic     arterial hypotension, and cerebral vasospasm. Cerebral vasospasm has been described as a     sustained arterial narrowing. Clinically, the onset of new or worsening neurological symptoms     is the most reliable indicator of cerebral vasospasm following a ruptured cerebral aneurysm.     However, cerebral vasospasm is often unrecognized in patients suffering from moderate to     severe TBI. These patients frequently have altered mental status due to the primary brain     injury. In addition, they require narcotics for their pain and paralytics and/or sedatives     while on a mechanical ventilator for airway protection. Thus, relying on the neurological     exam to observe deteriorating neurological signs consistent with post-traumatic vasospasm     (PTV) is reliable. While the etiology and outcome of patients with vasospasm secondary to     ruptured aneurysm is well documented, the clinical significance of PTV after TBI is unknown.     A better understanding of the role of cerebral autoregulation in the development of cerebral     vasospasm could provide the answer. This proposal is for a pilot observational study     describing the association of the impairment of cerebral autoregulation as measured by near     infrared spectroscopy (NIRS) with the development of clinically significant vasospasm in     patients with moderate to severe TBI. The information will serve as preliminary data for     further study.   "
71375|NCT02351505|"     This phase II trial studies how well selinexor work in treating patients with small-cell lung     cancer that has returned after a period of improvement. One specific way cancer cells     continue to grow is by getting rid of certain proteins called tumor suppressor proteins:     that would normally cause cancer cells to die. Selinexor works by trapping tumor suppressing     proteins within the cell and may cause the cancer cells to die or stop growing.   "
71376|NCT02351492|"     Patients with gallstone disease should be checked whether a common bile duct (CBD) stone     could be present. In case of a certain suspicion for CBD stones further investigations should     be performed. This can either be done by magnetic resonance cholangio-pancreaticography     (MRCP) or by intraoperative cholangiography. The study investigates which pathway would be     favorable in regard of an early hospital demission.   "
71377|NCT02351479|"     A six-month interventional program to determine the biological and psychosocial effects of     hula as a form of physical activity for female breast, cervical, endometrial or ovarian     cancer survivors living on Oahu.   "
71403|NCT02351141|"     The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in     120 asthma patient volunteers in order to characterize and probe the relationship between     lung structure and function using imaging.   "
71414|NCT02350998|"     This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with     bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will     receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the     middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The     study is designed to characterize safety and any procedural issues associated with TTT drug     administration of OTO-201.   "
71569|NCT02348970|"     To evaluate the efficacy (non-inferiority) in terms of response between patients using custom     fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made     devices TALI, after 2 months of use. Sleeping tests were performed.   "
71378|NCT02351466|"     The investigators have previously studied a group of young children with T1D using brain MRI,     age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18     months. The investigators observed significant differences in gray matter volumes and white     matter microstructure in the children with diabetes as compared to controls. These     differences appeared to increase over time, with slower rates of brain growth in the T1D     group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et     al, Diabetes 2015). In this new protocol the investigators will include the same children     with T1D and healthy controls previously studied and recruit new similar subjects to replace     those lost by attrition. The investigators will be using structural and functional brain MRI,     neurocognitive testing and measures of glycemic control, to determine if changes in the brain     persist or worsen over longitudinal follow up, and whether these changes are associated with     measures of glycemic control and neurocognitive metrics as these children grow and progress     through puberty.   "
71379|NCT02351453|"     The primary objective of AID study is to identify the medico-neuropsychological,     socio-economic and environmental baseline characteristics of dyads associated with the     institutionalization of AD patients.   "
71380|NCT02351440|"     The objective of this study is to determine the effect of preoperative duloxetine on     postoperative quality of recovery after ambulatory surgery, specifically laparoscopic     gynecological surgery.   "
71381|NCT02351427|"     The purpose of this study is to determine whether bortezomib is effective in the treatment of     acute cellular rejection after kidney transplantation.   "
71382|NCT02351414|"     MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total     Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by     regulatory authorities for all devices that do not have medium to long-term clinical evidence     available at the time of gaining approval to market in the EU. This study has been designed     in accordance with MEDDEV 2.12/2 rev 2.   "
71383|NCT02351401|"     Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through     self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint     swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on     the ability of patients to assess for clinical synovitis swollen joints in RA.   "
71384|NCT02351388|"     This project will investigate the safety and efficacy of transcranial direct current     stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease.     The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's     disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal     suppression on right supraorbital area. Active stimulation will be compare to sham condition     in 20 patients (10 in each groups).   "
71385|NCT02351375|"     This study will explore whether the IntelliCap® system can be used to study the human     microbiota composition in the small intestine. The IntelliCap® system is an oral drug     delivery and patient monitoring system consisting of a capsule-shaped device and ancillary     equipment. The IntelliCap® capsule is also able aspirate fluid from its environment. Here, we     explore whether the capsule is able to take a fluid sample from the lumen of the     gastrointestinal tract for microbiota analysis. To study this, a controlled dietary     intervention that is expected to induce a temporary change in microbiota composition will be     performed in healthy volunteers. Microbiota composition of samples collected from the small     intestine using the IntelliCap® system will be compared to fecal samples from the same     individuals collected at the same time point.   "
71436|NCT02350712|"     The purpose of this study is to test a study drug called patritumab. Patritumab may work when     combined with other medications that are approved in the UK for treating Squamous Cell     Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is     hoped that patritumab may have some benefit in treating patients with cancer. This study will     help identify how much patritumab can be given in combination with cetuximab, and cisplatin     or carboplatin. This study will show how safe and how well tolerated patritumab is when these     medications are given together.   "
71386|NCT02351362|"     Given there is substantial loss to follow-up soon after delivery among HIV-positive pregnant     women in South Africa, we will conduct a pilot study of an innovative approach to improve     retention in care targeted to this specific population at high risk of drop-out. The problem     of poor retention in care is well documented, but interventions to address the issue are     lacking. In order to design an effective intervention that will be tested in a future     randomized controlled trial, we will first complete preliminary research via a pilot study in     order to determine the feasibility and acceptability of an incentive program (i.e., a     supermarket voucher) to reduce loss to follow-up among HIV-positive women after delivery.      The primary objective of this study is to determine the feasibility of a voucher incentive     intervention aimed at improving retention in postpartum HIV care      Secondary objectives include: a) to determine the efficacy of the intervention at increasing     postpartum retention; b) to determine the acceptability of the intervention in terms of     women's preferences for the intervention compared to other possible interventions; c) to     assess differences in patient retention among women newly diagnosed with HIV vs. those who     knew their HIV-positive status before pregnancy; and d) to assess differences in patient     retention among women who initiated ART during pregnancy vs. those who were on ART before     becoming pregnant.      We will enroll up to 200 adult (≥18 years), pregnant, HIV-positive women attending antenatal     care who have not previously enrolled in the study at Hikhensile Clinic, Johannesburg, South     Africa. The study will be a prospective intervention cohort study with historical controls.     Intervention subjects will receive a one-time supermarket voucher of R50 (about $5.00) for     participants who return for at least one postpartum visit at the study clinic within 10 weeks     of delivery.   "
71387|NCT02351349|"     Chronic kidney disease is a common diagnosis in the elderly population and it is associated     with significant morbidity and health care costs. The prevalence rates increase with age to     about 40% for adults aged > 65 years. In the elderly population (age 65 and over), CKD is     associated with a higher burden of comorbid conditions and frailty. The prevalence of frailty     is higher in CKD patients with rated being double in early stages and nearly 6 times higher     beyond stage 3b. Previously reported frailty mortality rates of 18% at 3 years and 47% at 7     years comparing with mortality rates in non frail individuals of 3% and 12% respectively. In     this study, the investigators investigate the effect of multidisciplinary interventions upon     frail elderly patients with CKD not yet on dialysis. This interventions include best medical     care, nutrition, physiotherapy, and social, psychological and spiritual support.   "
71388|NCT02351336|"     If the investigators could prove that three -dimensional ultrasound measurement of fetal     adrenal gland volume can accurately predict the likelihood of preterm birth in patients     having symptoms and signs of PTL , they would be able to use it as a valuable component for     assessment and early management of high risk pregnant women for PTB which can be positively     reflected on the risk of neonatal morbidity and mortality in those patients.   "
71389|NCT02351323|"     Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative     obscurity to become one of the most serious complications of obesity in Hispanic obese     populations, especially among those with a family history of T2DM. Few therapies have     demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the     emerging evidence that glutamine and leucine (building blocks of protein) may affect energy     partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk     has been further evaluated in one adult observational cohort study but data on leucine are     lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce     insulin resistance, a diabetes risk factor.      The primary specific aim of the research plan is to conduct a randomized, double-blind,     placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine     in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic     adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history     of T2DM. At the end of the grant period, we will have obtained preliminary data to plan     pivotal clinical trials of glutamine coupled with or without lifestyle changes.   "
71390|NCT02351310|"     This is a randomized prospective clinical study that will evaluate the effects of antenatal     corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening     to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of     improving composite neonatal mortality and morbidity.   "
71391|NCT02351297|"     This study aims at evaluating the consequences of a 3 weeks high protein diet on the large     intestine ecosystem (microbiota, metabolites and gene expression in rectal mucosa). Those     parameters will be analysed with technics including OMICs methods. After a run-in period, 42     volunteers will receive either soy or milk protein or maltodextrin as a placebo control. This     trial is double blind randomized placebo-controlled paralleled design (3 arms). Longitudinal     sampling will allow the comparison of parameters during the study.   "
71392|NCT02351284|"     To determine the prevalence of hypovitaminosis D in HIV infected patients, and the     consequences on secondary hyperparathyroidism, and bone mineral density (BMD). Also, to     establish the improvement in vitamin D status, parathyroid hormone (PTH) and BMD, in case of     receiving vitamin D supplementation, during a follow up period of at least 1 year.   "
71393|NCT02351271|"     The aim of the study is to demonstrate the performance and safety of the Femtosecond     laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV     Z8 compared to conventional technique in cataract surgery.   "
71394|NCT02351258|"     The overall goal of this Community Central Line Infection Prevention (CCLIP) trial, supported     by grant R01 HS022870 from the Agency for Healthcare Research and Quality, is to determine     whether use of a promising new intervention, namely 70% isopropyl alcohol embedded protective     caps on central lines, in the home setting is associated with a reduction in ambulatory     central line-associated bloodstream infections (CLABSI) in a high-risk population of     pediatric hematology/oncology patients. Despite successes in CLABSI reduction efforts for     inpatients, it remains unknown what generalizable best practices should be with chronic     central lines in the home setting and how effective involving patients and caregivers across     multiple institutions in CLABSI reduction efforts will be. This research will involve a     cluster-randomized, cross-over design, clinical trial. This proposal will focus on the     caregivers integral to ambulatory pediatric central line care: patients and families. The     specific aims of the proposed research program are:      Specific Aim #1: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on     central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology     patients.      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be     associated with at least a 25% reduction in the ambulatory CLABSI rate for pediatric     hematology/oncology patients.      Specific Aim #2: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on     central lines reduces the rate of all positive blood cultures in ambulatory pediatric     hematology/oncology patients.      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be     associated with at least a 25% reduction in the positive blood culture rate at home for     pediatric hematology/oncology patients.      Specific Aim #3: Evaluate whether the use of 70% isopropyl alcohol embedded protective caps     on central lines changes the distribution of bacteria isolated from blood cultures of     pediatric hematology/oncology patients.      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will     reduce Gram-positive CLABSI, secondary blood steam infections, and single positive blood     cultures at home for pediatric hematology/oncology patients.   "
71395|NCT02351245|"     Lip hemangiomas are at higher risk than those located in other sites. However, studies about     clinical characteristics of lip hemangiomas have not been enough. The investigators want to     conduct a prospective study on the clinical features of lip hemangiomas.   "
71396|NCT02351232|"     A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an     add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes     patients in suboptimal glycemic control.   "
71437|NCT02350699|"     To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's     signal patterns with those of concussed high school athletes.   "
71397|NCT02351219|"     The study is conducted as a monocentric prospective phase II trial. Patients with     unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of     superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial     involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are     eligible.      After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for     a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.      In case of tumors have deemed resectable surgery is considered. In case tumors remain     unresectable, radiotherapy is evaluated after the end of chemotherapy.      Primary objective of the study is the rate of patients who become resectable and undergo     radical surgical resection after chemotherapy.      Secondary objectives are: response rate, progression-free survival, overall survival,     toxicity.   "
71398|NCT02351206|"     As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic     intervertebral disc change in young adults holds high clinical relevance as a common     structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray     disc space height measurements as a predictive evaluation method of lumbar disc herniation     (LDH) and degeneration in LBP patients in their early 20s.   "
71399|NCT02351193|"     While practicing the different assisted reproductive techniques, the investigators are faced     daily by the problem of poor responder females, and the debate about predicting its results     based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for     ovarian response, the need to re-assess its role was essential in our community, which led us     to conduct this prospective multi-center IVF study.   "
71400|NCT02351180|"     The purpose of this study is to determine if the use of inhaled beclomethasone after a     community-acquired respiratory viral infection in a lung transplant recipient decreases the     risk of the subsequent development of chronic lung allograft dysfunction.   "
71401|NCT02351167|"     Our goal is to identify the most appropriate smoking cessation treatments for smokers based     on genetic information. Smokers try to quit smoking but relapses are common.   "
71404|NCT02351128|"     The purpose of this trial is to evaluate the efficacy of lanreotide on locally evolving     and/or metastatic MCC in a national prospective multicentre phase II study (centres belonging     to the skin cancer task force of the French Society of Dermatology namely Groupe de     Cancérologie Cutanée de la Société Française de Dermatologie). This one-arm study, for which     the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one     step (A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001,     20:859-66) with main evaluation at 12 weeks on a population of 35 patients. The investigators     make assumption that a 40% success rate at 3 months would be desirable, but if it was 20% or     less the treatment would be unacceptable. It gives a trial size of 35 patients with a cut-off     of 12 patients. Over 12 patients lanreotide will be considered as effective.      The lanreotide treatment (Somatuline LP 120 mg injected subcutaneously every 28 days) will be     provided by IPSEN Pharma laboratory. An ancillary immunohistochemistry study on somatostatine     receptors 2,3,5, dopamine receptors 1,2 and polyomavirus MCPyV will bring new data on this     neuroendocrine tumour and potentially provide new therapeutic perspectives.      The results of this study may :        -  determine whether somatostatin analogues may help to treat locally advanced and/or          metastatic MCC;        -  address whether there is a correlation between positive SPECT-CT (octreoscan) assessment          and therapeutic response to lanreotide;        -  evaluate the place of TEP-CT and SPECT-CT for MCC evaluation/staging;        -  evaluate in future studies, with the ancillary data, other analogues or hybrid          molecules;        -  consider, if positive results are obtained from this study, somatostatin analogues as          adjuvant treatment after surgery of primary MCC.   "
71405|NCT02351115|"     The purpose of this study is to determine whether people who usually have photosensitive     epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato     Alprazolam as compared to placebo.   "
71406|NCT02351102|"     The purpose of this study is to determine whether Valacyclovir treatment, administered during     pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal     transmission rates and prevents fetal injury in cases of fetal infection.   "
71407|NCT02351089|"     The aim of the current Project is to study the efficacy of a probiotic Product in reducing     the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.   "
71408|NCT02351076|"     The aim of the study is to compare correlation for right to left shunts (mainly patent     foramen ovale) detection for three methods-transesophageal echo as a gold standard,     transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system     ( Cardiox TM) in young stoke patients ( age under 55 years).   "
71409|NCT02351063|"     HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure.     B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure.     Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II     is to demonstrate that the results of daily patient self-testing of BNP at home will provide     sufficient information to guide physicians to modify therapy and lower BNP levels over time.   "
71438|NCT02350686|"     Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced     biliary tract carcinoma after failure of gemcitabine-based chemotherapy.   "
71523|NCT02349568|"     Multiple reports in the literature showed the efficacy of EUS comparable to ERCP in the     diagnosis of common bile duct ( CBD ) stone. The EUS-based strategy has provided the cost     effectiveness in diagnosis of CBD stone in defined patient risk groups was showed in previous     studies. The aim of our study was to assess the cost effectiveness of EUS based strategy     versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risks for     CBD stones in a real working situation in a developing country.   "
71410|NCT02351050|"     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual     transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of     brain infarctions due to the activation of endogenous fibrinolytic system during angioplasty     and stenting of coronary arteries. 120 patients indicated for coronary angioplasty and     stenting will be enrolled into the study in order to demonstrate a twenty-percent risk     reduction of number and volume of brain infarctions detected using MRI examination 24 hours     after cardiac endovascular treatment in 5% level of significance. Patients will be randomized     - subgroup 1 will undergo a 40-240 minute non-diagnostic TCD monitoring during endovascular     procedure, subgroup 2 will undergo interventions without TCD monitoring.      Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous     fibrinolytic system during coronary angioplasty and stenting with consecutive reduction of     the number and volume of brain infarcts, can lead to the increase of the safety these     patients. We can presume that up to 50% of patients indicated for endovasular heart treatment     can be treated using these methods in the future.   "
71411|NCT02351037|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib     alone or in combination with either cytarabine or azacitidine in the treatment of subjects     with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without     prior therapy who refuse standard chemotherapy.   "
71412|NCT02351024|"     The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential     treatment of rheumatic and painful conditions. The study will compare the study drug to an     already marketed formulation of prescription strength naproxen (Naprosyn® the reference     product) by looking at how a single dose of the drug is taken up by the body. The safety and     tolerability of the drug will also be assessed.   "
71413|NCT02351011|"     Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition     in which the material that cushions the joints, called cartilage, breaks down. This causes     the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint     movement. Currently, there are few effective treatments available for patients suffering from     OA.      Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means     they have the ability to make copies of themselves and to turn into other kinds of cells     (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of     osteoarthritis, but much of the research is still in the early stages. In this study,     researchers want to determine the safety of MSCs that a patient can tolerate without causing     side effects. This will be done by starting at a low dose of MSCs and moving on to the next     higher dose level provided there are no safety concerns. Researchers will also be looking at     the function of the knee over time, which may give them some insight on the usefulness of     MSCs as a treatment option.   "
71445|NCT02350595|"     The potential health effects of high intake of lean or fatty fish will be investigated in     overweight or obese adults. Participants consume 750g/week of fillets of fish for 8 weeks.      Hypothesis:      High intake of fatty or lean fish will beneficially affect glucose regulation and the immune     system.   "
71415|NCT02350985|"     The presented study aims to compare effectivity of propranolol with effectivity of     venlafaxine in escalating dose in subjects with vestibular migraine (VM) over a period of 12     weeks. The study population consisted of subjects diagnosed definite VM according to criteria     of Bárány Society and Migraine Classification Subcommittee of the International Headache     Society (IHS). Effectivity of therapy was measured by Dizziness Handicap Inventory (DHI),     number of vertiginous attack of last month and visual analogue scale (VAS) reported dizziness     related Quality of Life (QOL). Beck Anxiety Inventory (BAI) and Beck Depression Inventory     (BDI) were also used to determine psychiatric improvement played role in response to therapy     in venlafaxine treatment arm.   "
71416|NCT02350972|"     In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether     autologous cytokines injected into cutaneous metastases would induce a systemic immune     response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that     had never been injected. Such immune responses were observed, and often the never-injected     metastasis regressed completely. 20% of patients remained free of disease for greater than 5     years.   "
71417|NCT02350959|"     The present study is intended to assess the vulnerability of plaques seen on CCTA by means of     TVC Imaging System and to make comparisons between plaques with adverse plaque     characteristics and ones without adverse plaque characteristics in terms of plaque volume and     lipid core contents.   "
71418|NCT02350946|"     The purpose of this study is to shed light on the basic neurobiological mechanisms which     underlie social information processing in healthy men. More specifically, we intend to     examine whether a person's social competence level is related to the patterns of neural     activity and his visual search strategies during evaluation of social scenes. Furthermore, it     will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to     the task will facilitate social information processing and thus enhance task performance.     Additionally it will be examined whether oxytocin can facilitate response inhibition in an     emotional context.   "
71419|NCT02350933|"     The purpose of this study is to determine whether possible damages of the trachea caused by a     prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and if     cuffed tracheal tubes cause less damages than cuffed tubes.   "
71420|NCT02350920|"     Over 18,000 Irish people are affected by the inflammatory bowel diseases (IBD), Crohn's     disease and ulcerative colitis. These illnesses often arise at a young age and can be     associated with significant physical disability. In addition, there is considerable     psychosocial disability associated with IBD. Previous studies have suggested that simple     psychological interventions may be valuable in improving quality of life and may even improve     disease activity. However, there has been no comprehensive trial to determine the precise     effect of psychological interventions on quality of life (QOL), stress or disease activity.     Our aim is to conduct a randomised controlled trial of a simple psychological intervention to     determine it's effect on QOL and stress   "
71451|NCT02350517|"     This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined with     paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or     metastatic esophageal squamous cell cancer.   "
71423|NCT02350881|"     Foot silicone implants suffer from bad reputation on the market, due to poor results obtained     with the first generations of implants. Allergies to silicone, infections due to silicone and     implants breakage used to be common with previous generations of silicone implants.     Publications relative to those implants showed that the survival rates after 5 years of     follow-up were unsatisfactory.      Since 1998, Tornier has been selling a new generation of silicone implants made of Ultrasil™.     The use of this new material in its manufacturing process together with its innovative     geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting implant.      The main objective of this study is to evaluate the clinical outcomes of the implantation of     Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in     terms of functional metrics from documented clinical data. Other objectives are to evaluate     the outcomes in terms of radiological evaluation and of safety during all the follow-up.   "
71424|NCT02350868|"     The Dose Escalation Phase will determine the MTD of MPT0E028 and evaluate its safety and     tolerability, PK, PD, and preliminary clinical effects; the subsequent Dose Confirmation     Phase will be a cohort expansion at or below the MTD (i.e., an RP2D) of MPT0E028.   "
71425|NCT02350855|"     The main aim of the study is to assess the effectiveness of tailored nutritional intervention     in delaying the progression of cachexia to refractory cachexia in adult female cancer     patients.      The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and     physical activity counselling) for six months, improved the anthropometric and biochemical     indices in free-living patients suffering from cancer cachexia.   "
71426|NCT02350842|"     Cardiac resynchronization is a recommended therapy for patients with advanced heart failure,     under optimized medical treatment with reduced left ventricular ejection fraction and     prolonged QRS, nevertheless, still 30% of the population do not respond to standard     biventricular implantation.      Non-response can be explained by a combination of factors including sub-optimal patient     selection, placement of the pacing lead over a zone of slow conduction, insufficient     correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data     distinguish true non-responders from patients in which effective resynchronization was not     delivered through standard biventricular implantation.      Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has     been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation     Therapy) CRT recipients.   "
71456|NCT02350452|"     Endometriosis is a benign chronic gynaecological disease that affects 10% of women of     reproductive age and takes 40% of them to assisted reproduction techniques.      The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular     count (AFC) , with the most common serological markers of ovarian reserve. The investigators     intend to confirm their clinical utility in the assessment of ovarian function, and to     promote their use in predicting decreased ovarian reserve.      The work therefore moreover arises the objective to validate the bibliographic data about     using the laser for haemostasis after stripping endometriomas, to amplify knowledge available     in the literature on the surgical treatment of ovarian endometriomas and on the diode laser     application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the     possible surgical implications on fertility .   "
71427|NCT02350829|"     Diffuse fibrosis (or scarring) of the heart muscle is found in a variety of congenital heart     diseases and in cardiomyopathies (heart muscle disease), and is considered a mediator of     decreased cardiac function. The detection and quantification of diffuse myocardial fibrosis     has recently become feasible non-invasively, using cardiac magnetic resonance (CMR), applying     a new technique labeled T1 mapping. With this technique, the part of the heart tissue which     is not made up of muscle cells (extracellular volume) can be quantified, as long as the     individual's hematocrit (cellular volume in the blood) is known. The extracellular volume in     the heart tissue is regarded as a quantifiable marker for the extent of diffuse myocardial     fibrosis.      In the proposed study this new T1 mapping technique shall be applied in patients with     different forms of congenital heart disease (n=130), cardiomyopathies (n=40) and in control     subjects (n=30). The additional scan time due to participation in the study will be     approximately 5-10 minutes, without changing the clinical protocol.      The main objective is to study the presence and extent of myocardial fibrosis by T1 mapping     CMR in pediatric patients with congenital heart disease and cardiomyopathies, in comparison     to cardiovascularly healthy controls.   "
71428|NCT02350816|"     This extension study will allow participants to continue receiving treatment with HGT-1410     and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and     will evaluate the long-term safety and efficacy of the study drug.   "
71429|NCT02350803|"     patients were enrolled by the inclusion criteria and were undergo lefort 1 maxillary     osteotomy. after the latency phase the distraction was done in anterior- posterior vector.     patients were divided by randomized allocation in 2 groups. in group 1 the distractor was     removed after consolation phase, and in group 2 fixation devices were placed immediately     after removal of distractors. data regarding relapse were analyzed by lateral cephalogram     X-ray taken in 3 different phases of the trial. change of occlusal plane and the A point of     the cephalometric analysis were determined as reference point of the study.   "
71430|NCT02350790|"     Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned     to either ablation or excision of endometriosis. The investigators think that patients who     have excision of endometriosis will have greater relief of pain.   "
71431|NCT02350777|"     The purpose of this study is to see if giving the patient stem cells their original donor     (boost) after removing the T cells (T cell depleted- TCD boost) without further chemotherapy.     The investigators want to see if this can improve bone marrow function. This would also     improve the patients white blood counts, red blood counts and platelets. This may make the     patients chances of improving and surviving better. The investigators will also be looking at     the short term side effects and risks of the TCD boost.   "
71432|NCT02350764|"     The purpose of this study is to closely examine tumor and blood samples from patients treated     with nivolumab and ipilimumab in order to try to identify why some patients with lung cancers     respond and why some patients do not.   "
71433|NCT02350751|"     The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared     to placebo when administered to healthy adult subjects.   "
71434|NCT02350738|"     This study evaluates the effects of Multimodal Cognitive Enhancement Therapy (MCET) for     people with mild cognitive impairment and early stage dementia by a randomized, controlled     (mock-therapy), double-blind, cross-over trial   "
71435|NCT02350725|"     The purpose of this pilot study is to investigate the pharmacodynamic and pharmacokinetic     parameters of a novel furosemide formulation administered subcutaneously as compared to oral     furosemide.   "
71452|NCT02350504|"     MRI has been recognized for many years as the safest and the most precise imaging method,     particularly for children. However, the accuracy of MRI demands from the patient to avoid any     movement while the examination is in process. This task is accomplished with difficulty by     children and requires the assistance of an anesthetizing staff. In this research, our main     goal is to investigate an introductory instruction as an assistive tool in performing MRI     without the need in anesthesia.   "
71439|NCT02350673|"     This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in     combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic     activity in participants with locally advanced and/or metastatic carcinoembryonic antigen     (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the     standard of care therapy. Enrolled participants who continue treatment will be treated until     loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will     include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated     treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be     modified if emerging data suggest a benefit.   "
71440|NCT02350660|"     Pilot study to assess the effect of oral immunotherapy on specific IgE levels and antigen     consumption in two distinct food allergies.   "
71441|NCT02350647|"     Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX     Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They     will be asked to complete questionnaires throughout the study and will receive an MRI, CT and     multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at     the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The     clinical and radiological outcomes will be compared between the study and control groups. It     is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL     REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.   "
71442|NCT02350634|"     The study is designed to examine the relationship between imaging results detected on a     18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.   "
71443|NCT02350621|"     A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with     radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive     posterior cervical foraminiotomy.      80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications,     health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively     (foraminotomy group).   "
71444|NCT02350608|"     Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the     patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The     monitoring will continue to the ward for two days. The data will be compared with the routine     monitoring methods.   "
71446|NCT02350582|"     Patients with breast cancer undergo a series of psiclofisicas alterations during cancer     treatment, chemotherapy phase being one of the more aggressive ete effect. These changes     reduce the quality of life and result in a loss of physical health-related condition. Studies     have shown that the practice of physical exercise and rehabilitation strategies enhance or     attenuate the impact of chemotherapy on quality of life of patients. At present,     technological development from telerehabilitación systems is a promising strategy that     enables fast and efficient communication between health professionals and patients,     especially at this stage of the disease where the patient may encounter difficulties in     matching measures improving their lifestyle with aggressive medical treatment.      To carry out this study a controlled study masked, parallel-group done were conducted usual     care control group and an intervention based on a web system telerehabilitación to improve     the physical condition associated with health and performed quality of life.   "
71447|NCT02350569|"     The primary objective of this study is to evaluate the antiviral efficacy of treatment with     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver     transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C     virus (HCV) infection who are undergoing primary liver transplantation.   "
71448|NCT02350556|"     For several years, the postural disorders assessment in hemiplegic patients was conducted     through force plate, using the center of plantar pressure displacement in a static position.      These are widely used in physical therapy both for assessment and rehabilitation of patients     with balance disorders.      For hemiplegic patients, an asymmetric distribution support on each foot and an increased     surface area of postural sways (more marked on the medio lateral axis) are observed.      These studies, based on the study of plantar pressure ,are not enough to providea full     description of the spatio-temporal organization of postural components in hemiplegic     patients.      Indeed, postural stabilometric evaluation is based on a simplification of the human skeleton     by considering it as a simple inverted pendulum swinging on his ankles.      This simplified model can't be used in dynamic assessment because of the simultaneous     contributions of several joints during movement. This restricts its clinical interest because     patients are more exposed to imbalances and falls in dynamic situations. Thus, the hip     angular movement results in a center plantar pressure displacementwhich is impossible to     discriminate from the ankle axis movement using stabilometric signal only.      Thus, it seemed interesting to study another variable valid in dynamic conditions : the     displacement of center of mass during a dynamic balancing task. This variable is obtained     through 3D motion capture of the different segments of the human body. The dynamic test is a     dynamic postural assessment following ball avoidance from three different directions. The     center of mass displacement will be compared with a functional test known to be     representative of dynamic balance of the individual capacities: The Timed Up and Go test     (TUG).      All of this data aims to improve the hemiplegic postural assessment for physical therapy and     to help develop new rehabilitative approaches.   "
71449|NCT02350543|"     This study evaluates the continuation (non-discontinuation) of Aspirin during TURBT. Half of     participants will continue their usual low-dose Aspirin regimen during TURBT and throughout     the perioperative period, while the other half will discontinue Aspirin use ten days prior to     surgery (standard recommendation) and restart therapy two weeks post-discharge.   "
71450|NCT02350530|"     BACKGROUND:      For patients with liver-limited metastatic colorectal cancer (mCRC), complete resection of     liver metastases is the only potentially curative treatment. The current goal of medical     treatment for colorectal cancer with initially unresectable liver metastases is to maximize     the rate of secondary resection and prolong overall survival (OS). A strong correlation was     found between response rate and secondary resection rate of metastases, and the triple drugs     combination of infusional 5-fluorouracil/leucovorin (5-FU/LV), irinotecan, and oxaliplatin     (FOLFOXIRI) was recommended can be used in selected patients with potentially resectable     metastases in order to improve response rate and make resection more possible. The addition     of a anti-VEGFs monoclonal antibody such as bevacizumab to chemotherapy has been shown to     increase response rate, resection rate and improve OS in the first-line treatment of mCRC     patients. The efficacy and safety of bevacizumab in addition to triplet drugs were previously     tested in OLIVIA trial, the resection rate of liver metastases of 49% was reported, and the     response rate was 81%; most common grade 3-4 adverse events was neutropenia. On the basis of     such promising results, we conducted the present randomized study to explore whether     FOLFOXIRI plus bevacizumab compared with FOLFOXIRI alone as first-line treatment could     improve radical resectability in patients with RAS mutation-type, unresectable liver-only     metastatic colorectal cancer.      OBJECTIVE:      The primary objective of the FOBULM study is to evaluate the efficacy of FOLFOXIRI plus     bevacizumab compared to FOLFOXIRI alone in patients with initially unresectable liver-limited     RAS mutation-type mCRC.      Secondary objectives are safety and tolerability of the treatment, efficacy in terms of     objective response rate (ORR), OS, progression free survival (PFS), quality of life and an     assessment of biomarkers for predictive response and prognosis.   "
71453|NCT02350491|"     Rheumatoid arthritis (RA) is a systemic disease, which mainly targets joints and results in     osteoarticular destruction and serious disability. When clinical symptoms (painful and     swollen joints) occur, the innate and adaptive immune responses against self antigens have     already been largely amplified. This might explain that even when RA patients are treated     very early and aggressively, a remission of the disease can only be obtained in approximately     half of them. This proportion of remission under treatment can only be achieved using treat     to target strategies involving biologics, such as anti-TNF. Unfortunately, less than 20% of     patients remain in remission after treatment discontinuation. Thus, despite the availability     of 5 different types of biologics, there are still therapeutic unmet needs. However, a     spontaneous, drug-free decrease of disease activity can be observed in a physiological     condition, pregnancy. Although most of treatments of RA have to be discontinued during     pregnancy, a marked improvement, and sometimes remission, can be observed during pregnancy,     with frequent post-partum flares. The situation is the opposite with an increased risk of     flares in systemic lupus erythematosus (SLE), a rare systemic autoimmune disease which     generally progresses in flares-up and can affect nearly any organ (the skin, joints, kidneys,     the brain, the heart, …). The course of the disease remains unpredictable for a given     patient, and very few biomarkers are available to help clinicians to identify patients a risk     of flares. Thus, safe therapeutic options remain limited, especially in patients with serious     complications. A specific concern in SLE is the fact that the disease usually starts in women     entering their sexual and reproductive life. Even with a stable condition (i.e : lupus     without recent flares and no impaired renal or cardiac function) as it is medically     recommended before getting pregnant, up to 40% of SLE patients flare up during pregnancy.      We hypothesize disease-specific and pregnancy-induced epigenetic changes, especially those     regarding the pattern and levels of microRNAs, could explain the clinical improvement and the     risk of flares in RA and SLE, respectively. A better understanding of the underlying     mechanisms could help to identify new biomarkers, notably those predicting flares in SLE, and     therapeutic targets, by trying to mimicking or amplifying micro-RNA changes observed in RA     and targeting them in SLE.   "
71454|NCT02350478|"     This study is planned to evaluate if linagliptin can improve endothelial function in patients     with type 2 diabetes mellitus. In addition, the effect of linagliptin on arginine     bioavailability ratios and postchallenge glycaemic control will be studied.   "
71455|NCT02350465|"     The objectives of this study are to: 1) validate a rapid, portable, cost-effective method for     screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel     approach to progressive resistance exercise involving eccentric muscle actions that will     counter the local effects of myosteatosis and sarcopenia in African Americans.   "
71464|NCT02350348|"     To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive     factors that can be responsible for poor outcome.   "
71465|NCT02350335|"     All patients with acute aneurysmal hemorrhage are treated in accordance with our     institutional protocol. After securing of the aneurysm, some smokers with acute aneurysmal     hemorrhage are randomly assigned to transdermal nicotine replacement (NRT). The short- and     long-term effect of NRT will be studied comparing non-smokers, smokers without NRT and     smokers with NRT.   "
71457|NCT02350439|"     Fractional flow reserve (FFR) is an established invasive method for assessing the     physiological significance of coronary artery stenosis. However, in recent studies it has     been observed and reported some degree of variation in the fraction of the coronary artery to     the aortic pressure (Pd / Pa) during the infusion of standard adenosine dose (140mg/kg/min).     The observed variation may be attributed to a failure to achieve maximal hyperemia with the     normal dose. The administration of adenosine at a higher dose (200μg/kg /min) may influence     coronary flow reserve (FFR) eliminating Pd / Pa variation during adenosine infusion.      This is a prospective study which will be conducted in patients after coronary angiography     with at least one angiographic lesion ≥50% in coronary vessels.      Patients after written consent will undergo assessment of lesion severity with FFR under a     three-minute infusion of adenosine 140mg/kg/min. In patients during steady state hyperaemia     (determined by visual assessment) exhibiting variation in Pd / Pa ratio ≥ 0.05 (e.g.     difference of max Pd/Pa minus min Pd/Pa) the examination will be repeated after 5 min with     three-minute infusion under high dose adenosine (200mg/kg/min). The minimum ratio Pd/Pa per 3     beats will be offline analyzed. The FFR during steady hyperemia state is defined as the     average of the minimum ratio Pd / Pa per three beats.   "
71458|NCT02350426|"     This is an adaptive Positron Emission Tomography/ Computed Tomography (PET/CT) and Dynamic     Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) open-label study design for the     investigation of inflammation in adult rheumatoid arthritis (RA) patients, not involving     therapeutic intervention. Each study participant will undergo two half body PET/CT scans from     the pelvis to the bottom of the feet (including hands and wrists) with an additional bed     position centred on the shoulders. One scan will be conducted with 18F-FDG and the other with     18F-GE-180. The first PET/CT scan (PET1) will be performed 4 weeks (28 +/- 2 days) after the     first screening visit, whereas the second PET/CT scan (PET2) will be carried out within 2     weeks (7 +/- 7 days) after PET1. The order of PET/CT scans for each subject will be based on     a computer generated randomisation schedule after the screening visit. A sub-group of study     participants will be invited to undergo an additional dynamic 18F-GE-180 PET scan of a     selected joint (knee or wrist) prior to their 18F-GE-180 PET/CT half body scan. The primary     objective of the study is to quantify inflammation in joints of RA patients by determining     18F-FDG and 18F-GE-180 uptake using PET, and DCE-MRI parameters.   "
71459|NCT02350413|"     The experience of the chronic illness negatively engraves on the quality of life of patients.     Endometriosis is a disease that affects millions of women of childbearing age; it has     repercussions on psychological health, as shown by numerous recent studies.      The aim of the present study is to validate the italian version of EPH 30, a self reported     questionnaire, already used internationally, in order to determine the quality of life in     women with endometriosis, assess their psychological health and the effectiveness of     therapies.   "
71495|NCT02349932|"     A person's blood type is defined by the types of sugars they express on their red blood     cells, with antibodies being made to non-self sugars and excluding blood cells expressing     these sugars (the basis of blood transfusion reactions). These same sugars can be expressed     by commensal bacteria in our gut lumens. The investigators hypothesize that a person's     antibodies to non-self sugars also attach to and exclude non-self sugar-expressing bacteria     in our guts. Supporting our hypothesis, a person's blood type correlates with the overall     composition of their gut flora. Because these sugars are also used by certain pathogens to     initiate infection, this information could directly inform our understanding of host     susceptibility to various infectious organisms.   "
71460|NCT02350400|"     Background      Hepatic metastases of colorectal cancer (MCC) is quite common and is a major source of     morbidity and mortality. There has been evidence to show that hepatic arterial     chemoembolisation using DC beads (drug eluting beads, 100-300μm) loaded with irinotecan     (DEBIRI) showed improved overall survival when compared to systemic therapy (FOLFIRI), but     being larger they have their limitations.      New 70-150μm beads are recently available and currently there is limited data concerning its     use. Safety of these beads have not been tested in local patients.      Hypothesis / Aim To study the safety and pharmacokinetics of the smaller 70-150μm DEBIRI in a     pilot study of 5 patients. The smaller 70-150μm beads will be able to deliver a more     consistent and higher dose to tumoral tissue with a smaller systemic dose. Being smaller and     less embolic, it will also be better tolerated. Patients will also be genotyped for their     UGT1A1*28 and UGT1A1*6 polymorphism status as the latter genotypes are associated with     decreased clearance of irinotecan and SN-38 in Asian patients.      Methods Single centre, pilot study, prospectively recruiting 5 patients with unilobar     disease, refractory to systemic chemotherapy      The primary endpoints:        1. establish safety and toxicity profile of the irinotecan loaded DEBIRI beads        2. establish pharmacokinetics and systemic exposure of irinotecan and its active          metabolite, SN-38.      The secondary outcome measurements:        1. the incidence and severity of adverse events, liver function parameters and laboratory          abnormalities;        2. response rate,        3. progression free survival        4. overall survival      Clinical Significance      This treatment modality has the advantage of directly delivering irinotecan to the liver     metastases from colorectal cancer. This local mode of drug delivery may result in a higher     intratumoral drug concentration and rapid tumour shrinkage leading to downstaging of the     hepatic metastatic lesions. These therapeutic outcomes may also downstage patients to hepatic     resection.   "
71461|NCT02350387|"     The purpose of this study is to determine if there are differences in balance, strength,     functional performance and self-reported outcomes for subjects with knee osteoarthritis who     complete a low intensity, long duration eccentric training program compared to those who     complete a high intensity, short duration eccentric training program. This study will be     utilizing the Eccentron (manufactured by BTE Technologies) for the performance of all     eccentric exercise.   "
71462|NCT02350374|"     The total amount of carbohydrates (CHO) at meal consumed strongly predicts the glycemic     response in children and adolescents with type 1 diabetes. Carbohydrate counting is a     technique to adapt a dose of rapid acting insulin to the carbohydrate content of a meal.     Thanks to this flexible insuline therapy, the glycemic control and the quality of life tend     to improve. Carbohydrate counting is a recommended technique in the adult diabetic     population. There is little data on the use of this methode in youth with diabetes. There are     no studies on the change of carbohydrates content at meals in children and adolescents with     diabetes practicing counting carbs, while it is the main interest of this technique. The aim     of this study is to assess how children and adolescents with type 1 diabetes use the     possibility to change their carbohydrate amount at each main meal when they use the counting     carb method. The investigators hypothesize that children vary their amount of CHO greatly.     This is an argument for using this technique in pediatrics   "
71463|NCT02350361|"     Here we are going to find a method by using available multiple drugs including angiogenesis     medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but     have responsed to it before.   "
71466|NCT02350322|"     The aim of this study is to assess the effects of giving a schoolmeal with fatty fish, a     schoolmeal without fish or omega-3 capsules on Noregian adolescents cognitive performance     (concentration and learning abilities), mental health statua and markers of nutritional     status. In addition, to disentangle the effect of fatty fish eaten as food and the effects of     omega-3 fatty acids taken as a supplement.   "
71467|NCT02350309|"     This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage     strengths of E2006 (5 mg and 10 mg) in subjects with insomnia disorder.   "
71468|NCT02350296|"     The present bioequivalence phase I study is needed to compare the bioavailability and the     concentration-time profile of the new immediate release formulation of KLS 40 mg with the     reference compound OKi®, ketoprofen lysine salt 80 mg granules for oral solution (bipartite     sachets).      The objective of the study is to investigate the bioequivalence between two formulations     containing ketoprofen lysine salt (KLS) when administered as single oral dose in two     consecutive study periods to healthy male and female volunteers under fasting conditions.   "
71469|NCT02350283|"     To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute     stroke within 12 hours of symptom onset.   "
71470|NCT02350270|"     The main objective of the GOOD initiative was to determine which spatio-temporal gait     parameters and/or combination(s) of spatio-temporal gait parameters best differentiate     between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI)     and those with mild and moderate dementia.   "
71471|NCT02350257|"     The primary objective of this study is to test the effectiveness of internet-delivered and     therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety     disorders (including social anxiety disorder, separation anxiety disorder, generalized     anxiety disorder, panic disorder and specific phobia) in a randomized trial where     participants will be allocated to either ICBT or to a supportive control condition.     Non-responders (defined as those participants who still uphold their primary anxiety disorder     after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are     conducted at 3 and 12 months after treatment completion.   "
71472|NCT02350244|"     Evaluate the benefit of an intervention by a computer program comprising active breaks, in     the form of a personalized self-program on functional impairment and / or pain, among     employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in     connection with the computer work environment.   "
71496|NCT02349919|"     The purpose of this study is to investigate the effectiveness of oral procaterol in treatment     of non-asthmatic patients who suffer from persistent cough following upper respiratory tract     infection (URTI).   "
71524|NCT02349555|"     This open label study seeks to study the effects of a nutritional supplement on inflammatory     markers, metabolic parameters, and safety in subjects compared to baseline after taking     supplement for 2 and 4 months.   "
72214|NCT02340507|"     This study is carried out to find out the inclusion of high and low glycaemic Index (GI)     foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.   "
71473|NCT02350231|"     Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of     these multiple births being twin births . Preterm birth defined as birth occurring prior to     37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in     the United States.      Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are     at increased risk of developing respiratory distress syndrome, sepsis, intraventricular     hemorrhage, and necrotizing enterocolitis.      Twin pregnancy is considered one of the important risk factors of preterm birth. Over     distension of uterus may be one of the etiological factors for preterm birth. However, no     definite effective interventions have been shown to prevent preterm delivery in twin     pregnancy.      Three large randomized trials suggested that progesterone might prevent preterm delivery in     high-risk singleton pregnancy especially those with previous preterm delivery or short cervix     might be reduced by antenatal progesterone.      Fonseca et al (2007) concluded that women with short cervix are less likely to deliver     preterm ≤34 weeks if they are treated with vaginal progesterone.   "
71474|NCT02350218|"     The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared     to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST     levels followed by Eglandin administration were assessed.   "
71475|NCT02350205|"     This clinical trial is designed to assess the safety, effectiveness and benefits of Self     Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of     full-thickness burn wounds that require permanent coverage where the availability of donor     sites is limited.   "
71476|NCT02350192|"     Cardiovascular disease (CVD) is the leading cause of death globally and e-health educational     programs have been proved to be effective support to CVD clients. However, most e-health     programs lack personalization and this seldom results in exercise behavioral change.     Considering the advantages of e-health programs, as well as the widespread internet use and     the rising trend of younger patients having CVD in Hong Kong, we conducted a Randomized     Controlled Trial (RCT) to investigate the effectiveness of a home-based interactive e-health     educational intervention versus usual care for middle aged cardiac vascular (CV) patients on     their total physical exercise, exercise adherence and quality of life.   "
71477|NCT02350179|"     The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss     during and after elective C.S.      The Research Question Is Tranexamic acid effective in reducing blood loss during and after     elective Caesarean section?      The Research Hypothesis The TXA could be able to reduce blood loss during and after elective     Caesarean section.      The null hypothesis will therefore state that:      There will be no difference between TXA and placebo in reducing blood loss during and after     elective Caesarean section.   "
71489|NCT02350023|"     Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical     corticosteroids are the established agents for treating this disorder. There are several case     reports and case series which have demonstrated the efficacy of topical prostaglandins. The     two agents have not been compared head-to-head in the published literature. The investigators     attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost     in the treatment of localised alopecia areata.   "
71478|NCT02350166|"     Surgical resection is still recommended as the optional treatment for colorectal liver     metastasis (CLM) patients. There are two main concerns for resectable colorectal liver     metastasis which remain controversial: surgical time and surgical type. As for the former,     synchronous resection of primary colorectal tumor and liver metastasis, with the reason of     fare overall survival rate and absence of a second surgery, has gained wide population from     gastrointestinal surgeons who believe it will bring benefits to CLM patients. With regard to     surgical type, Open liver resection is the optimum choice for CLM patients no matter what the     metastasis profile is. And for management of primary tumor, laparoscopic procedure is mature     in surgical skill and has been evidenced equivalent overall survival rate compared with open     resection. So, primary colorectal tumor resection could be either open or laparoscopic     procedure. Therefore, the investigators team conducted the controlled trial to compare two     surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be     randomly assigned into conventional laparotomy group for simultaneously resection of both     primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group     for resection of laparoscopic colorectal tumor combined with synchronously small-incision     open resection of liver metastasis. The aim of this trial is to observing short-term     operative effects after surgeries.   "
71479|NCT02350153|"     The purpose of this study is to study since 1987 all patients diagnosed with CD in Sweden and     determine their outcomes including mortality. A secondary objective is to focus on patients     in remission and identify determinants of their different outcomes.   "
71480|NCT02350140|"     Early accurate diagnosis is one of the first crucial steps in care for infants born to     HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early     diagnosis and results in significant reductions in infant morbidity and mortality. The     investigators recently concluded a successful randomized controlled trial in Kenya entitled,     Improving uptake of early infant diagnosis of HIV for prevention of mother-to-child HIV     transmission (PMTCT): a randomized trial of a text messaging intervention     (ClinicalTrials.gov # NCT01433185). In this study, text messages developed using a behavioral     theoretical framework significantly improved maternal attendance at post-partum clinic     appointments and rates of testing to facilitate early infant diagnosis of HIV in a selected     population and controlled setting. Understanding the effectiveness of this intervention (and     its limitations) in a real-world, routine-care setting represents the next step in the     translational pathway to public health impact. The investigators therefore now propose a     cluster randomized, stepped wedge trial in 20 clinics operated by the Kenyan Ministry of     Health in the Nyanza region of Kenya and use the Reach, Effectiveness, Adoption,     Implementation, and Maintenance (REAIM) framework to understand the effectiveness of the text     messaging to improve testing (TextIT) intervention. Our specific aims are:        1. To determine the effect of TextIT on maternal attendance at postpartum clinic visits          during the randomized stepped-wedge rollout of the intervention.           Hypothesis 1: A greater proportion of women at health facilities implementing TextIT          will attend clinic within eight weeks postpartum compared to women at health facilities          implementing standard care.        2. To determine the effect of TextIT on virological infant HIV testing within eight weeks          after birth during the randomized stepped-wedge rollout of the intervention.           Hypothesis 2: Infants of women at health facilities implementing TextIT will be more          likely to have virological HIV testing compared to infants of women at health facilities          implementing standard care.        3. To determine the costs and cost-effectiveness of TextIT. The investigators will estimate          the cost per patient and per health gain achieved (disability-adjusted life year, DALY)          comparing TextIT to current standard care.      Hypothesis 3: The TextIT intervention will be more cost-effective than current standard care.   "
71497|NCT02349906|"     The aim of the trial is to describe the safety and efficacy of intravenous (i.v.) Treosulfan     compared to the conventional (myeloablative) dose of i.v. Busulfan, each administered as part     of a standardised Fludarabine-containing conditioning regimen and to contribute to a PK model     which permits - in conjunction with data comparing Treosulfan and Busulfan in adults with     malignant diseases - to extend the use of Treosulfan in the paediatric population by     extrapolating efficacy.   "
71525|NCT02349542|"     The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine     in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the     use of a standardized periarticular injection containing free bupivacaine and liposomal     bupivacaine.   "
71481|NCT02350127|"     Nearly 1 in 10 older Veterans have dementia, which is a devastating condition that leads to a     progressive loss of independence and functional status. Currently available dementia     medications do not alter the disease course. Therefore, it is critically important to     identify effective strategies for helping older Veterans living with dementia to enhance     their functional status and quality of life. The investigators have developed a novel,     integrative exercise program called Preventing Loss of Independence through Exercise (PLIE)     that incorporates elements from Eastern and Western exercise modalities and is designed to     build and maintain the capacity to perform basic functional movements while increasing     mindful body awareness and enhancing social connection. Pilot study results suggest that PLIE     is associated with meaningful improvements in physical function, cognitive function and     quality of life as well as reduced caregiver burden. The goal of the current study is to     perform a full-scale randomized, controlled trial to test the efficacy of PLIE in older     Veterans with dementia.   "
71482|NCT02350114|"     This is an observational study of the functional capacity of patients with Heart failure with     Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical     treatment.   "
71483|NCT02350101|"     In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was     introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM.      Goal of this retrospective study is to evaluate the influence of this algorithm on     coagulation, use of blood products, coagulation factors and ROTEM evolution.   "
71484|NCT02350088|"     To evaluate the safety and efficacy of Hirschsprung's disease   "
71485|NCT02350075|"     The aim of this study is to determine the clinical success of short implants (6mm) alone and     standard implants (10mm) combined with sinus floor elevation in atrophic maxilla.   "
71486|NCT02350062|"     Different neuromuscular monitors may be available in the same care structure. Two different     monitors are available in the investigators' institution in the operative room and the     recovery room. However, these two monitors have not been compared and may not be     interchangeable. Starting the monitoring with one device and continuing with another device     may be inaccurate and may lead to inadequate medical decisions. The investigators therefore     conducted this observational study to compare the two devices available in our institution.   "
71487|NCT02350049|"     The purpose of this study is to evaluate the safety and effectiveness of the Cementless     Oxford Partial Knee System.   "
71488|NCT02350036|"     50 pregnant females were divided in two groups, twenty five as a control group and twenty     five as high risk group; they were subjected to uterine artery Doppler, measurement of     maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14     weeks of gestation, all pregnancies were followed until 40 weeks for development of     pre-eclampsia   "
71490|NCT02350010|"     There were lack of data and analysis about medical management, etiology, and long-term     outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do     acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk     factors of ICH. Further the investigators will aim to develop and validate a risk score for     predicting 1-year functional outcome after ICH.   "
71491|NCT02349997|"     Fluid retention in the legs due to chronic heart failure (CHF) during the daytime may     redistribute to neck when with supine positioning at night. A portion of the shifted fluid     accumulates in the neck, and narrows the upper airway, predisposing the patient to     obstructive sleep apnea (OSA) and central sleep apnea (CSA). However, the mechanism of     overnight fluid shift on OSA and CSA remains unclear. The investigators pre-experiment     demonstrated there may be a different mechanism of overnight fluid shift on OSA and CSA. The     accumulation of water content in neck soft tissue increases neck circumference and leads to     pharyngeal resistance, upper airway collapse and causes OSA. The effect of nocturnal fluid     shift on CSA may be because of increasing of chemosensitivity (fluctuation of PaCO2),     circulation delay and hemodynamic disordered. This study is aimed to explore the different     mechanism of overnight fluid shift on OSA and CSA by comparing the changes of upper airway     (inside diameter, water content, and pharyngeal resistance), PaCO2, circulation delay     (lung-to-finger circulation time) and hemodynamic (loop gain).   "
71492|NCT02349971|"     This study looks to examine the feasibility and efficacy of using MR-HIFU to ablate Osteoid     Osteoma lesions in children and young adults.   "
71493|NCT02349958|"     To determine treatment response to surgical debulking and intra-operative Intraperitoneal     Hyperthermic Chemotherapy (IPHC) in patients with the following malignancies:      Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical     cancers).      Mesotheliomas. GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon,     appendix).      To monitor the toxicities and complications of this treatment regimen. To measure treatment     related QOL changes after IPHC.   "
71494|NCT02349945|"     CONDITION: Idiopathic male infertility In men with idiopathic infertility, the sperm DNA     fragmentation index (DFI) within 12 weeks of FSH therapy and 12 weeks follow-up improves     depending on the FSHR genotype as assessed by the non-synonymous SNP rs6166 (wild type or     p.N680S).      This is a phase II b, multicenter, prospective, open label, one arm, clinical trial     stratified according to the patient's genotype.      INTERVENTION: FSH therapy (150 I.U. sc every other day for 12 weeks) in infertile men who are     homozygous for the wild-type FSHR or the p.N680S allele of the FSHR. Duration of intervention     per patient: 12 weeks      Primary efficacy endpoint: Sperm DFI. Number of patients with an improvement in DFI > 60% Key     secondary endpoint(s): pregnancy, semen parameters, serum levels of inhibin B and AMH.   "
71522|NCT02349581|"     This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain     after breast cancer surgery.   "
72216|NCT02340481|"     The purpose of this study is to evaluate the efficacy and safety of combined loperamide     hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating     acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas     accumulation.   "
71498|NCT02349893|"     The United States is currently experiencing an increase in the incidence and prevalence of     obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the     population, untreated OSA has been implicated in increased risk for cardiovascular disease,     including hypertension and heart failure, daytime sleepiness, and increased risk of motor     vehicle accidents.      This study was design in order to evaluate the CelonProSleep plus for multi-level     radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to     moderate obstructive sleep apnea syndrome (OSAS).   "
71499|NCT02349880|"     Shared decision-making is being promoted as a promising approach for engaging patients with     schizophrenia in medical decisions and improving satisfaction and adherence.      To implement shared decision-making, both physicians and patients should commit to it and     engage in a mutual decision process. Most research, however, has addressed interventions that     either focus on the doctors' side (e.g. communication skills) or on informing patients     about treatment options (e.g. decision aids). These approaches have been shown to be     feasible in clinical practice but had no strong effects on treatment patterns or adherence,     possibly because they were insufficient to motivate and enable patients to engage actively in     decision-making. Moreover, these interventions still rely on the doctor's willingness to     share decisions, which has been shown to vary considerably.      To overcome these limitations and since many patients do not feel competent to participate in     decision-making we developed an intervention that focuses on patients' communicative     competencies. this intervention, a five session group-training, will be implemented for     inpatients suffering from schizophrenia.   "
71500|NCT02349867|"     This is a phase 1 study of concurrent chemoradiation using a regimen of sorafenib and     vorinostat with gemcitabine and radiation following chemotherapy in patients with pancreatic     cancer to find the RP2D of the concurrent chemoradiation combination. A traditional 3+3     dose-escalation design will be conducted for the sorafenib and vorinostat dose escalation.     Adenocarcinoma of the pancreas without distant metastasis that has been treated with ≥ 1     prior therapy (not including radiation) encompassing at least 2 months. Adequate hematologic,     hepatic, and renal function. Ability to take oral medication. To determine the doses and     schedule appropriate for phase 2 study of sorafenib and vorinostat with concurrent     gemcitabine and radiation therapy (RT) as neoadjuvant treatment of pancreatic cancer     following chemotherapy.   "
71512|NCT02349711|"     In this randomized, double-blind, placebo-controlled study, participants with seasonal     allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess     health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse     events, and compliance. In a subset of subjects, stool and blood samples will be collected at     baseline and at week 6 of the intervention (estimated to be peak allergy season) to     characterize microbial communities and immune function.   "
71513|NCT02349698|"     The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen     receptor T cells and to determine the proper dosage of CAR T cells infused.   "
72626|NCT02335125|"     The goal of this pilot study is to develop and implement a larger scale, multi-site stepped     collaborative care trial that targets injured patients with presentations of Posttraumatic     Stress Disorder (PTSD) and related comorbidity.   "
71501|NCT02349854|"     Seborrheic dermatitis is a common, inflammatory skin condition that causes flaky, white to     yellowish scales to form on oily areas such as the scalp or inside the ear. These scales can     occur with or without underlying reddened skin. In addition to causing psychological     distress, low self esteem, and embarrassment, seborrheic dermatitis is associated with scalp     pruritus (itch). Treatment modalities exist to control scalp flaking and itch associated with     seborrheic dermatitis, although such therapies often lose efficacy over time. As seborrheic     dermatitis is a chronic (life-long) condition, better treatments are needed. The     investigators propose to better characterize in subjects with seborrheic dermatitis involving     the scalp versus normal scalp controls: (a) the clinical characteristics of the associated     itch and (b) the pattern of nerve innervation to the scalp. In this way, the investigators     hope to get a comprehensive understanding of the factors causing scalp itch with the aim that     this information will create new candidates to which treatment modalities can be designed. At     least 12 (up to 20) subjects and similar number of control subjects without disease will have     one clinic visit including questionnaires, testing of sensation on the scalp, and biopsy of     the scalp.   "
71502|NCT02349841|"     To evaluate the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics     of meropenem administered intravenously three times a day, plus amoxycillin/CA administered     orally three times a day; and of faropenem administered orally three times a day, plus     amoxycillin/CA administered orally three times a day; for 14 consecutive days, in adult     participants with newly diagnosed, smear positive pulmonary tuberculosis, in order to help     establish proof-of-concept for carbapenem antibiotics as antituberculosis agents and to     select the appropriate agent and route of administration for later stage clinical     development.   "
71503|NCT02349828|"     A prospective, randomized trial to calculate incidence of Herpes Simplex Virus in an     in-patient burn population and determine efficacy of prophylactic antiviral therapy to     prevent viral infection and/or reactivation. Hypothesis is that antiviral prophylaxis will be     effective in reducing HSV infection/reactivation.   "
71504|NCT02349815|"     -  To describe characteristics (demographic, clinical, social) of first time users of          Jaydess.        -  To estimate the duration of use of Jaydess.        -  To study switching patterns, e.g. what are the hormonal contraceptive methods used          before and what are the methods after discontinuing Jaydess.        -  To study off-label use of Jaydess   "
71505|NCT02349802|"     Phase I study to determine the device-related injection failure rate of the single-use,     pre-filled autoinjector.   "
71506|NCT02349789|"     Gait and balance disturbances are one of the most incapacitating symptoms of Parkinson's     disease (PD) (Boonstra et al. 2008). They can cause falls and are therefore associated with     the negative spiral of (near) falls, fear of falling, fractures, reduced mobility and social     isolation; hence, having a profound negative impact on quality of life (Lin et al. 2012).     Originally, symptoms of PD were ascribed to dopamine deficiency and basal ganglia dysfunction     (Wu et al. 2013). However, in the last decades it has become clear that other brain     structures are also involved in the pathophysiology of PD (Snijders et al. 2011; Stefani et     al. 2007). An intriguing, emerging insight is that the cerebellum may be involved in the     pathophysiology of PD (Wu et al. 2013). That is, the cerebellum is hyperactive in PD patients     during different motor tasks (Yu et al. 2007; Hanakawa et al. 1999; del Olmo et al. 2006).     However, whether cerebellar hyperactivity is pathological or compensatory and how it affects     gait and balance in PD patients remain open questions. Here, the investigators aim to     elucidate the role of the hyperactive cerebellum in gait dysfunction in PD patients by     modulating cerebellar excitability with state-of-the-art non-invasive brain stimulation     techniques and investigate the effects on gait.   "
71566|NCT02349009|"     1:1 active treatment: placebo, blinded trial, evaluating the effect of a 4-week treatment     period with topical C-82 on skin expression of two gene biomarker surrogates (THBS1 and COMP)     for the modified Rodnan skin score (MRSS). Study subjects will be randomized to apply the     active study medication daily for 4 weeks to either the right or left forearm and placebo to     the contralateral forearm.   "
71507|NCT02349776|"     Allograft transplants are offered to people with haematological cancers sometimes as the best     chance of a cure. However, the survival rates for these procedures can be quite poor, as the     transplant, in itself, can be lifethreatening.      In addition, these procedures usually involve a period of lengthy hospitalisation accompanied     by a host of debilitating conditions which patients must cope with in isolation due to their     increased risk of serious infection. Perhaps unsurprisingly, there is considerable evidence     that mood plays a role in the way people recover.      I wish to investigate the psychological impact of providing testimonies from survivors of     transplants to patients undergoing the procedure.      The plan is initially to collect about 10-15 testimonials from past transplant patients using     a videotaped structured interview then to collate these testimonials into a booklet format     and DVD.      This booklet and DVD would be used as an intervention where 40 consecutive patients who are     going ahead for transplant are invited to receive the testimonial intervention.      Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test     (LOT), and a questionnaire about expectations of treatment in clinic once a decision to     proceed to transplant has been made. Patients will receive the testimonies upon admittance to     the transplant unit and then receive the HADS and a structured interview within the first     week of being admitted to the transplant ward (just prior to receiving the transplant) and     within the first two weeks following the transplant.      Comparative analyses of the measures between the three time points would be performed and     qualitative analysis of the structured interview data.      Around 80 people undergo transplant each year, it is estimated that the project will be     completed by September 2016. The intention would be to publish following completion.   "
71508|NCT02349763|"     Comparison of the efficacy and side effects of intravenous and oral regimens of dexamethasone     for prophylaxis of paclitaxel-associated hypersensitivity reactions in primary ovarian,     fallopian tube and peritoneal cancer patients receiving first cycle of combination paclitaxel     and carboplatin.   "
71509|NCT02349750|"     The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate     for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU     of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG     was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C     received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to     36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients     had failed trial underwent another trial of IUI for a maximum of three trials.   "
71510|NCT02349737|"     Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and     implantable cardioverter defibrillators (ICDs).   "
71511|NCT02349724|"     The main purpose of this research is to verify the safety of CEA targeted chimeric antigen     receptor T cells and to determine the proper dosage of CAR T cells infused.   "
71514|NCT02349685|"     As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter     pylori (H. pylori) therapies has been declined coincidently. In this study, the investigators     evaluated the efficacy of H. pylori eradication between a personalized therapy for H. pylori     infection based on the results of antibiotics resistance by using H. pylori culture and     minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens, and the     investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of     H. pylori in the tailored therapy group.   "
71515|NCT02349672|"     Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic     asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature     newborns. Between 10-60% of babies who exhibit HIE die during the newborn period and up to     25% of the HIE survivors have permanent neurodevelopmental handicaps in the form of cerebral     palsy, mental retardation, learning disabilities, or epilepsy. HIE also has a significant     financial impact on the health care system. In the state of Florida, the total cost for     initial hospitalization is $161,000 per HIE patient admitted, but those costs don't take into     account the life-long costs.      Current monitoring and evaluation of HIE, outcome prediction, and efficacy of hypothermia     treatment rely on a combination of a neurological exam, ultrasound, magnetic resonance     imaging (MRI) and electroencephalography (EEG). However, these methods do a poor job in     identifying non-responders to hypothermia. MRI requires transport of the neonate with a     requisite 40-45 min scan, which is not appropriate for unstable neonates. Moreover, the     amplitude integrated EEG (aEEG), a common bedside monitoring technique currently used in     these patients to assess candidates and predict outcomes prior to hypothermia, can be     adversely affected by hypothermia itself and the patient may not appear to improve until     re-warming. Consequently, the development of a simple, inexpensive, non-invasive, rapid     biochemical test is essential to identify candidates for therapeutic hypothermia, to     distinguish responders from non-responders and to assess outcome. This research is the first     step needed to treat neonates with HIE employing a personalized medical approach using serum     proteins GFAP and UCH-L1 as biomarkers and by monitoring neonates responses to therapeutic     hypothermia. These biomarkers will aid in the direct care by providing a rapid test to     predict outcomes and select candidates who are likely to benefit from therapeutic hypothermia     and gauge a response to the neuroprotective intervention.   "
71516|NCT02349659|"     24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing     Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM.     Subject population is chronic inguinal pain refractory to previous surgical intervention     (neurectomy).   "
71517|NCT02349646|"     10-SMI-2012 is a post market observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     peripheral neuropathy   "
71518|NCT02349633|"     Phase 1: The Phase 1 study is an open label, multi center, multiple dose, non randomized,     safety, pharmacokinetic, and pharmacodynamics dose escalation study of PF 06747775 as a     single agent in patients with advanced EGFRm NSCLC (del19 or L858R, +/ -T790M).      Phase 2: an open label, multi-center, single arm study of PF-06747775 for the assessment of     anti-tumor activity in patients with advanced EGFRm (del19 or L858R) advanced NSCLC with     T790M (del 19 and T790M or L858R and T790M) and further pharmacokinetic characterization.   "
71519|NCT02349620|"     The main objective of this clinical trial study is to consider the effect of     Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental     implants.   "
71520|NCT02349607|"     This study will examine the activity of PF-05089771 and pregabalin, alone and in combination     on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in     healthy male subjects   "
71521|NCT02349594|"     To evaluate the effects of infusion of a Fish oil-based lipid emulsion on TNF-α production     and other relevant immune functions. A soybean oil emulsion, rich in the omega-6     polyunsaturated fatty acid linoleic acid, will serve as control.   "
71526|NCT02349529|"     Children and young people with epilepsy are at increased risk of poorer outcomes related to     emotional and psychological adjustment, peer relationship problems, lower academic attainment     and mental health problems across the lifespan. Despite the well understood risks, there     continues to be a lack of psychological and psychosocial support for young people with     epilepsy, and a corresponding lack of evidence regarding the effectiveness of psychosocial     interventions. This study aims to evaluate a manualised psychosocial group intervention for     adolescents with epilepsy. A cognitive behaviour therapy approach is used, aimed at     increasing awareness of how epilepsy may impact upon thoughts, feelings and activities and to     develop strategies for improved psychological adjustment. In addition, an epilepsy knowledge     component aimed at improving a sense of control and epilepsy self-management is included. A     group delivery format allows an opportunity for social modelling, and social problem solving,     helping others and relating to other young people with similar experiences. The social     learning context and availability of knowledgable facilitators (an epilepsy nurse specialist     and clinical psychologist) are also key aspects of the intervention. The study will allow us     to establish a standard manualised group intervention that can be used throughout the UK     which aims to; establish the effectiveness and desirability of this approach; improve the     overall quality of life, psychological health and social integration of young people with     epilepsy; and to improve epilepsy knowledge and selfmanagement skills aimed at maximising     seizure control and overall management.   "
71527|NCT02349516|"     A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in     combination with Ranibizumab intravitreal injections in patients with diabetic macular edema.     The study duration is 52 weeks and patients will be randomized to one of four treatment arms.   "
71528|NCT02349503|"     This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with     congenital adrenal hyperplasia (CAH). The study will be conducted in approximately 15     adolescent females (12-18 years of age) with a documented medical diagnosis of classic     21-hydroxylase deficiency CAH. The study will include three independent dose cohorts of     NBI-77860 (approximately 5 subjects per dose cohort). Ascending doses will be evaluated as     part of a sequential-cohort design.   "
71529|NCT02349490|"     Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact     (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human     intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding     site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal     is applied after an initial failure of the institutional standard method. Homeostatic success     is determined by 5 min without bleeding at gastrointestinal site. after application of     Seraseal.   "
72627|NCT02335112|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Head and Neck Neoplasms.   "
71532|NCT02349451|"     This study is a Phase 2 randomized, double-blind, double-dummy, active- and     placebo-controlled, parallel-group study designed to assess the safety, tolerability,     efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants     with active PsA who are inadequately responding to MTX treatment.   "
71533|NCT02349438|"     This study will test the feasibility that differences in contact lens wettability can be     measured with a wavefront sensor.   "
71534|NCT02349425|"     A randomized, double-blind, placebo-controlled, crossover, dose escalation study of     gefapixant (AF-219) in subjects with Refractory Chronic Cough.   "
71535|NCT02349412|"     The study intervention consists of the early integration of palliative care services into     standard oncology care in an outpatient setting for patients with advanced lung and     non-colorectal gastrointestinal malignancies who are not being treated with curative intent.     The palliative care services provided to patients randomized to the intervention will be     provided by board-certified physicians and/or advanced practice nurses and will focus on the     following areas: (1) developing and maintaining the therapeutic relationship with the     patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing     support and reinforcement of coping with advanced cancer in patients and family caregivers;     (4) assessing and enhancing prognostic awareness and illness understanding in patients and     family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care     planning.   "
71536|NCT02349399|"     The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol     (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics,     previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne     treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases     in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).   "
71537|NCT02349386|"     The objective of this clinical study is to evaluate the safety and efficacy of three     different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the     maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate     cancer.   "
71538|NCT02349373|"     Running is a natural part of human locomotion and humans have been running for million of     years. In modern society, running has become a popular way of exercise and is undertaken by     many people worldwide, possibly because it provides a cheap and easily accessible form of     exercise, and the positive effects of running on health and fitness are well known.     Unfortunately, running is also associated with a high risk of injury.      The purpose of this project is to investigate how a running schedule which focuses either on     running distance or running speed influence the overall risk of injury and the types of     injury sustained in recreational runners.   "
71539|NCT02349360|"     The purpose of this research study is to determine the effects of the probiotic,     Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria     and blood biomarkers in healthy individuals.   "
72237|NCT02340208|"     The primary purpose of this research study is to evaluate how safe, how well tolerated and     how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung     cancer when given as a monotherapy.   "
71540|NCT02349347|"     The purpose of this study is to assess the efficacy of intensified intravenous Melphalan in     combination with a transplant of patients' own blood stem cells for a maximum of three     cycles.      In a recently completed small Phase I study looking at the use of higher doses of intravenous     Melphalan with the combination of lenograstim (a drug that stimulates bone marrow to produce     white blood cells helping to fight infection) and patients' own blood infusion over 4 cycles     of treatment has proved encouraging. The results of this study showed rapid improvement in     pain and a fall in circulating tumour cells within two weeks of starting Melphalan. However,     slow platelet recovery after the fourth cycle meant longer periods of platelet transfusion.     For this trial we intend to assess the efficacy of an intensified intravenous Melphalan with     transplant of patients' own blood stem cells over a shorter time period. This study will     involve approximately 39 patients over a 3 year period.   "
71541|NCT02349334|"     Faecal incontinence occurs when a person passes faeces (stools) without the usual control. It     is a distressing condition that is actually very common although under-reported because of     embarrassment. Milder symptoms may be managed by treatments such as dietary change, drugs and     bowel retraining, but many patients still resort to surgery to improve symptoms. Although     several operations exist to treat incontinence e.g. those aiming to repair damaged anal     sphincter muscles, it is now clear that these often have poor results.      Two relatively new treatments called sacral nerve stimulation (SNS) and percutaneous tibial     nerve stimulation (PTNS) involve sending pulses of electricity to the nerves controlling the     bowel and muscles of the anus (anal sphincter).      SNS does this by inserting electrodes in the lower back just above the tailbone and     connecting them to an implanted electrical stimulator which is buried in the buttock and acts     a bit like a heart pacemaker. SNS is a relatively well-established treatment in specialist     centres, which has been used for over 10 years. It has been shown in studies to be successful     for faecal incontinence achieving some improvement in at least three quarters of patients. In     Europe, this procedure is fast becoming first treatment offered when non-surgical treatments     fail. Nevertheless, SNS is not a miracle cure for all, requiring 2 operations, with potential     complications and expensive equipment (> £10,000 approx).      PTNS is a newer treatment, which involves electrically stimulating a nerve at the ankle,     using a very small needle, as an outpatient (a bit like acupuncture). This sends signals back     to the spine region to try and improve symptoms of faecal incontinence. Since this is a newer     treatment, fewer studies have been performed to quantify how successful it is, but early     results of PTNS suggest that it may be as good as SNS. If this is true, this is very     important because it is much less invasive and considerably cheaper than SNS (equipment £500     per patient).      This project will for the first time determine how effective PTNS is in the treatment of     patients with faecal incontinence, by comparing it to sham (fake stimulation). This study is     a properly designed clinical trial of 212 patients in at least 14 UK Specialist Centres.. The     results of this trial will lead to direct benefits for patients and the NHS.   "
71542|NCT02349321|"     Development and evaluation of a multi-faceted school-based intervention to prevent intimate     partner violence among Grade 8 high school students in South Africa   "
71543|NCT02349308|"     The purpose of this study is to demonstrate the stability of blood flow with the CentrosFLO     catheter, during intermittent dialysis over a period of 6 months after placement.   "
71544|NCT02349295|"     The main purpose of this study is to evaluate how effective and safe the study drug known as     ixekizumab is in participants with active psoriatic arthritis.   "
71714|NCT02347072|"     Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover     Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe     COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium     Bromide) as an Active Control, and Placebo.   "
71545|NCT02349282|"     In an ageing population, the need for interventions to help older people remain healthy,     active and independent for as long as possible, increases. Although several studies suggest a     beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical     functioning, particularly in vulnerable populations, results are contradicting. Randomized,     placebo-controlled trials are needed to further establish the effect of vitamin D on muscle     strength in the frail elderly population.The primary aim of this study is to determine the     effect of daily supplementation with two different forms of vitamin D on muscle strength in     frail elderly people over a period of 24 weeks.   "
71546|NCT02349269|"     The aim of the investigators trial was to evaluate association between new onset     postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.   "
71547|NCT02349256|"     The study uses in depth interviews to understand their experience of somatoform disorder,     possible explanations and their experience of somatoform disorder, possible explanations and     their understanding of treatments, especially their ideas about psychosocial treatments.   "
71548|NCT02349243|"     This is a randomized, controlled, double blind clinical trial. The purpose of this study is     to investigate the weight loss efficacy of entacapone. In this study, participants are     randomly divided into entacapone and placebo groups. The percentage change in body weight,     the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat,     serum insulin, serum triglyceride and the adverse effects are compared between the two     groups.   "
71549|NCT02349230|"     Subjects were randomized into 3 treatment groups (15 subjects per group): 1) Control -     received no treatment 2) Placebo - received a sham Astym® treatment 3) Astym® Treatment -     received Astym® treatment to the lower extremity. Subjects were blinded to whether they     received the Astym® treatment or placebo treatment intervention. After a 5-minute warm-up on     a lower body ergometer the subjects were familiarized to the operations of a computerized leg     press machine that measured the maximum force output (Newtons) during a unilateral isometric     squat test. A baseline measure of maximal force output (pre-test) was determined by the     average of 3 trials with a 30 second rest period between the trials. The subjects then     received the designated treatment intervention. Immediately following the treatment     intervention (0 minutes following treatment intervention) the subjects were retested     (post-test) using identical testing procedures by an investigator blinded to the treatment     intervention received by the subject. Maximum force output measured in Newtons for the     post-test was subtracted from the maximum force output (Newtons) pre-test and then converted     to a percentage of change [(post-test - pretest)/pretest X 100). The percent change of     maximal force output from pre-test to post-test measures was compared using a one-way     analysis of variance with alpha set at 0.05. A Tukey's post-hoc analysis determined     statistical differences between the groups.   "
71550|NCT02349217|"     The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention     on relationship satisfaction with quality of life and immune system function among breast     cancer survivors and their partners.   "
71551|NCT02349204|"     Music is commonly heard in operating room. The goal of this study is to measure the effect of     music on surgical performance using a intraocular surgery simulator. The music chosen is     Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the     simulator, both with and without music, in a randomized sequence. The results will be     subtracted from the simulator and analyzed.   "
71552|NCT02349191|"     This study is a prospective, single arm, non-randomized, interventional study to evaluate the     safety and effectiveness of Omental transposition (OT) in subjects with early stage AD.      Within-subjects (repeated-measures) design will be utilized to compare follow-up outcomes to     baseline.      The following assessments will be performed at baseline, then at 1, 3, 6, 12, and 24 months     following surgery:        -  Montreal Cognitive Assessment (MoCA)        -  Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog)        -  General Practitioner Assessment of Cognition (GPCOG)        -  Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) Subjects who          have early stage AD confirmed by a neuropsychological test (MoCA) and who are healthy          enough to undergo surgery.      The experimental procedure to be performed is omental transposition (OT) surgery. It will be     performed as a laparoscopic or open procedure for omental lengthening and an open procedure     for brain access, with a general surgeon performing the omental lengthening/tunneling and a     neurosurgeon performing brain access/brain biopsy/omental placement on brain.      Up to twenty-five (25) subjects, with the first 5 subjects being part of a learning curve     group and the next 20 subjects being part of the experimental group.      The duration of each subject's participation will be approximately 25 months from screening     through the 24 month follow-up visit.   "
71553|NCT02349178|"     This is a Phase 2 study designed for the purpose of estimating various parameters surrounding     the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual     disease (MRD) in acute leukemia patients otherwise in remission and without causing     significant delay of HCT due to treatment related toxicity.      A single course of bridge chemotherapy is given prior to the transplant procedure as an     approach to improved disease-free survival in a patient group who historically has had     inferior outcomes.   "
71554|NCT02349165|"     The gold standard corneal crosslinking (CXL) technique involves the initial step of     epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation     of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL     (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a     solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is     performed. This solution seems to facilitate riboflavin penetration into the corneal stroma     through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL     with the advantage of a faster healing time and less risk of infections.   "
71555|NCT02349152|"     This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery     to supress the hyperglycemic response in perioperative period. Half of the participants will     receive continuous intravenous remifentanil during surgery, while the other half will receive     intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl     administration is this institution's standard of care.   "
71746|NCT02346656|"     15-SMI-2013 is a post market, observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     chronic post surgical groin pain   "
71556|NCT02349139|"     This study will be conducted in three parts. Part A is a dose-escalation study to determine     two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate     cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the ASN001     through blood sampling. Subjects in Part B will receive one of two doses identified in Part A     to determine which one is more effective, and collect additional pharmacokinetic data. Part C     is an extension for subjects completing either Part A or B.   "
71557|NCT02349126|"     Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or     tenofovir and be evaluated for safety and efficacy.   "
71558|NCT02349113|"     This study is being done to study age-related bone changes in women. The investigators know     that the major cause of osteoporosis is a shortage of the female hormone estrogen. This study     will look closer at how this shortage of estrogen works to cause a decrease in bone     formation.   "
71559|NCT02349100|"     To determine FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis. Does     uncomplicated EVAR using the nellix endoprosthesis result in increased FDG uptake and false     positive PET imaging?   "
71560|NCT02349087|"     In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed     a fast EEG electrode, that is suitable for acute emergency use. This study will address the     clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been     resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and     EEG will be recorded for 24 hours.   "
71561|NCT02349074|"     Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among     the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest     shock.      The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in     digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage     has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI     tract and their potential involvement in the post-CA shock is therefore unknown.      We propose an original clinical research program aimed at rigorously determining the     incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of     post-CA shock through a prospective, interventional, multicentric study   "
71562|NCT02349061|"     The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a     reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus     (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis,     kidney problems, and anemia, among other problems).   "
71563|NCT02349048|"     The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen     containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not     having received treatment with any approved or investigational drug) participants with     chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early     stages of liver fibrosis or with cirrhosis.   "
71564|NCT02349035|"     The purpose of this study is to improve prosthesis control for transradial amputees with     combining targeted muscle reinnervation surgery (TMR) and pattern recognition control.   "
71565|NCT02349022|"     The purpose of this study is to compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT     with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate     cancer pre-prostatectomy as confirmed by pathology.      Individuals participating in this study will have a [111In]-capromab pendetide scan, as well     as a PET scan following the injection of [89Zr]-Df-IAB2M.   "
71567|NCT02348996|"     Adequate control of extracellular volume is a major goal of renal replacement therapy in     patients with chronic renal disease. Fluid overload is present in the early stages of chronic     kidney disease and contributes significantly to hypertension, arteriosclerosis and high     prevalence of left ventricular hypertrophy. These are associated with high rates of morbidity     and mortality in this group of patients, rates on dialysis in Brazil is around17.9 % per     year. Dry weight during hemodialysis remains a delicate gap between hypervolemia and     hypovolemic. Many studies have shown that tight control of post - dialysis weight is related     to better outcomes in short term and higher long-term survival. Many methods have been     proposed for estimating the hydration status of hemodialysis patients in an objective manner,     including ultrasonography of the inferior vena cava and echocardiography. However, these     methods are very time-consuming and cumbersome to use in daily practice. In most dialysis     centers, the dry weight is evaluated on subjective clinical criteria, with trial and error     and time consuming. It was recently introduced in Brazil to monitor body composition by     multifrequency bioimpedance, called Body Composition Monitor ( BCM ) manufactured by     Fresenius Medical Care. The BCM is a piece of bioimpedance spectrometry using a three     compartment model, able to quantify objectively and accurately the extracellular volume and     hydration status of each patient by measuring body resistance to an electric current. The     procedure is safe, simple and relatively inexpensive. The BCM uses multi-frequency currents     (ranging from 5 to 1000 KHz ). The availability of this device evaluation of body composition     which assesses the dry weight more efficiently and objectively determine a target to be     achieved to prevent left ventricular hypertrophy, hypertension better manage and improve     cardiovascular outcomes, motivates us to perform this study. So the goal is to compare the     efficacy between bioelectrical impedance analysis and clinical evaluation for suitability of     dry weight in hemodialysis patients. A prospective, randomized, crossover study, which will     include all chronic renal failure patients on hemodialysis at St. Luke 's Hospital (PUC -     RS), including patients with at least three months on HD and over 18 years of age. The     expected primary outcome is to achieve greater accuracy in determining the state of hydration     and dry weight of these patients.   "
71568|NCT02348983|"     Being obese can be a risk factor for many health problems, including high cholesterol, high     blood pressure, low back pain, heart attacks and some cancers. Truckers, who are integral to     our economy, face challenges that put them at increased likelihood of being obese. The     investigators want to come up with a program to help drivers get to a healthy weight and stay     there.      The WHEEL pilot study is a 12 week weight loss intervention in long-haul commercial truck     drivers. The study involves two visits to the University of Utah's Rocky Mountain Center for     Occupational and Environmental Health, one at the start of the study and a second one at the     end of the study. Both visits include a general health history questionnaire, a 24-hour diet     recall questionnaire, anthropometric measurements, as well as an assessment of blood     pressure, hemoglobin A1c, and a cholesterol and lipid panel. Each truck driver is assigned a     health coach who helps the driver create and achieve three health goals.      The health coach works with the driver to set individualized goals specific to weight loss,     and contacts the driver weekly to check in and tweak goals as needed.      Drivers are also compensated for their participation in the study and get to keep all of the     intervention materials that the investigators give them. All that the researchers ask is that     they try their best to have a healthier lifestyle and give us feedback on what they liked and     didn't like in the study.   "
71570|NCT02348957|"     CML requires ongoing treatment and assessment of treatment milestones in order to manage the     disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and     CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to     prior therapies including Imatinib. Although Imatinib has demonstrated unprecedented efficacy     in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML     is managed in real-life clinical practice settings. Therefore this non-interventional study     is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine     with respect to first and second line treatment and/or switch setting (within 1st line or     from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered     doctor's practices as here most of CML patients who are not involved in clinical trials are     treated.   "
71571|NCT02348944|"     The purposes of the study are to assess intra individual biological variability of serum and     urinary cartilage specific biomarkers and define the best standardized conditions for blood     and urine sampling in the frame of biomarkers dosage.   "
71572|NCT02348931|"     Investigation of the effect of customized nasal braces in the correction of nasal deformities     with and without prior corrective surgery.        -  Trial with medicinal product   "
71573|NCT02348918|"     A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical trial Designed to     Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin®     and Focal Laser Photocoagulation in the Treatment of Diabetic Macular Edema   "
71574|NCT02348905|"     ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis   "
71575|NCT02348892|"     The large share of chronic diseases correlated with an aging population calls to develop     necessary coordination between the hospital and non-hospital (professional of the city, home     ...) to create new complementarities.      Since July 2013, the Nantes University Hospital experiences the establishment of a     coordinator route patient in Gerontology. The evaluation program of the benefit of     coordinating the course in elderly patients in health establishment (PROCOPES) must allow to     prove the efficiency of the intervention of a coordinator route patient, following elderly     patients in complex situations, both within the hospital and outside the hospital (home,     nursing home,...). The objective of PROCOPES is to show the added value of an innovative     position that can make the link between the hospital and the city on deemed complex     situations.The pilot study results present a strong interest for health care settings,     nursing home and in the world of research. It will also permit to have preliminary data for     bigest studies.   "
71576|NCT02348879|"     This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists     of a 21 day screening period followed by administration of the investigational product and up     to 154 day evaluation period.   "
71577|NCT02348866|"     This study will determine if there is a difference in bacterial contamination (CFU/cm2)     between obstetric resident surgical scrubs donned at home and those donned at the hospital.   "
71686|NCT02347436|"     The known correlation between benign prostatic hypertrophy (BPH) and hypertension could be     explained by 3 theoretical pathway models. Whether hypertension causes BPH, BPH causes     hypertension or the two are caused by a common factor is currently unknown.      In this study it will be investigated whether hypertension is due to the direct effects of     infravesical obstruction to urinary outflow in patients with benign prostatic hyperplasia.     The approach will be blood pressure measurement in patients who will have a resection of the     prostate.   "
71578|NCT02348853|"     U.S. Army Medical Research & Materiel Command Telemedicine and Advanced Technology Research     Center (TATRC) is sponsoring the HF2 (Healthy Families, Healthy Forces) Study. This is a     randomized trial comparing two different interventions for sustainable weight loss.     Specifically, the investigators will compare a current best practice(CBP) intervention that     includes standard dietary advice with a new, Healthy Weight for Living (HWL) intervention     that includes recommendations to eat a diet rich in protein, dietary fiber, low glycemic     index carbohydrates and low calorie foods. The objective of this study is to compare the CBP     and HWL interventions when delivered to adult dependents of active duty (AD) military     personnel and measure weight loss effects in both the adult dependents and the AD military     personnel they live with.   "
71579|NCT02348840|"     The purpose of the study is to explore ways to improve maternal and child outcomes in the     ethnic Maya speaking the Kaqchikel language population, which experiences wide disparities in     health care access and outcomes when compared to other inhabitants of Guatemala who are not     ethnically Maya and live in other parts of the country.   "
71580|NCT02348827|"     The aim of the present study is to compare an intervention consisting of Family     Psychoeducation (FPE) to an active control intervention of social support for relatives of     patients with a diagnosis of major depression.   "
71581|NCT02348814|"     The overall aim of this study is to validate a quantitative digital tool for staging liver     fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in     patients.   "
71582|NCT02348801|"     Older people with diabetes will be assigned to the 1-year lifestyle program or no lifestyle     program while continuing usual treatment for diabetes. The lifestyle program will consist of     teaching how to practice healthy diet and regular exercise at our facility and continued into     the community and home. It is hoped that the results would provide convincing proof about the     usefulness of lifestyle change in older patients with diabetes.   "
71592|NCT02348671|"     The purpose of this study is to investigate if wound dressings are capable in reducing the     effects of shear- force at the skin. With our own shear- force model we are able to apply 19     Newton shear- force combined with 9 newton pressure at the skin of the non- dominant forearm.     After half an hour we measure IL-1alpha/ total protein- ratio, cutaneous blood flow (Laser     doppler, Moor LDI) and the erythema index (DSMIIColormeter) which occurs as an effect of     shear- force application at the skin.      Then, we apply 19 Newton shear- force combined with 9 Newton pressure at the dominant     fore-arm but this time we put a wound dressing between the skin and shear- force model. After     half an hour we measure the IL-1alpha/total protein-ratio, cutaneous blood flow and the     erythema index.      This research consists of three research day, each day we are going to investigate a     different wound dressing   "
71593|NCT02348658|"     This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of     single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.   "
71583|NCT02348788|"     Both artemether-lumefantrine and chloroquine are currently used and recommended by Malaysian     Ministry of Health as blood stage treatments for non-severe P. vivax and P. knowlesi malaria.     Microscopic misdiagnosis between Plasmodium species remains a large issue in Sabah, Malaysia     and elsewhere. In order to facilitate potential policy change to a unified ACT guideline for     all malaria species in Sabah artemether-lumefantrine needs to be evaluated for P. vivax     malaria.      Preliminary data in a recently completed RCT evaluating artesunate-mefloquine vs chloroquine     for P. vivax showed up to 36% P. vivax recurrence with chloroquine monotherapy by day 28 post     treatment without primaquine. Based on these data blood stage chloroquine treatment failure     rates should also be evaluated in the context of standard concurrent (rather than delayed)     liver stage primaquine dosing, due to both its potential blood stage synergistic effect in     addition to known decreased recurrence rates. As artemether-lumefantrine is one of the     current first line Ministry of Health ACTs used in Sabah with a lower adverse event profile     compared to artesunate-mefloquine, this was recommended as the more appropriate ACT to     evaluate against chloroquine.   "
71584|NCT02348775|"     We have recently reported that older patients with HIV are deficient in glutathione (GSH) due     to decreased availability of cysteine and glycine, and that oral supplementation with     cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and     improves (but does not fully normalize) concentrations of red-cell GSH. We also found that     when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with     an increase in intracellular GSH concentrations. These older HIV patients also had     significant increases in muscle strength with improvement of GSH levels.The current proposal     in older HIV patients will investigate study if cysteine and glycine supplementation for a     duration of 12 weeks will result in changes in : (a) GSH levels; (b) body     composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial     energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and     glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months,     GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests     will be measured for a further 2 months to determine the effects of washout.   "
71585|NCT02348762|"     The investigators have previously reported that older patients with HIV are deficient in     glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral     supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their     own levels, and improves concentrations of red-cell GSH. The investigators also found that     when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an     increase in intracellular GSH concentrations. The current proposal will investigate if     cysteine and glycine supplementation for a duration of 24 weeks will result in changes in :     (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of     life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative     stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months after     completing supplementation, measurement of GSH concentrations, strength, function,     mitochondrial energetics and neurocognitive tests will be done to determine the effects of     washout.   "
71586|NCT02348749|"     The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl     Guanidine) behaves in the body after injection, how it spreads to all the organs and how it     is removed from the body. We will also study how long 18F-MFBG lasts in the blood after     administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a     PET-CT scan.   "
71587|NCT02348736|"     A randomized controlled prospective study of laryngoscopy and intubation time comparing     SensaScope and the McGrath® Series 5 video laryngoscope.   "
71588|NCT02348723|"     The primary objective of this trial is to assess the safety of an uninterrupted dabigatran     etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen     in NVAF patients undergoing AF ablation in a PROBE (Prospective, randomized, open label,     blinded end point) active controlled study.      Secondary objectives are to assess additional safety endpoints and efficacy in this clinical     setting.      It is not intended to assess confirmatory hypothesis, this is an exploratory study.   "
71726|NCT02346916|"     The purpose of this study is to determine whether there is a positive correlation between the     ability to sense chest pain in the context of myocardial ischemia and the ability to sense     discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active     ingredient on hot chili peppers).   "
71589|NCT02348710|"     This randomized controlled trial will test a multicomponent intervention to increase exercise     Outcome Expectations (OEs) and assess effects of OE changes on exercise intentions and levels     of exercise. Sixty early stage breast cancer survivors will be recruited from the Duke Cancer     Institute. Participants will be randomized to the exercise OE intervention or an attention     control group. Both groups will receive the American Cancer Society diet and exercise     guidelines and an accelerometer. The intervention group will also receive an OE workbook     containing self-directed activities to increase OEs by focusing on OE importance (value     placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and     accessibility (frequency with which the outcome(s) are thought of). The attention control     group will receive a workbook containing the same activities focused on diet, rather than     exercise.   "
71590|NCT02348697|"     Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and     adolescent patients with full thickness cartilage defects after the treatment with NOVOCART     3D.   "
71591|NCT02348684|"     The association between radiation exposure and cardiac disease is well recognized, it is not     fully understood if there exists an optimal or safe radiation dose-volume relationship.   "
71594|NCT02348645|"     The purpose of this study is to assess the feasibility of a full-scale multicenter     randomized, controlled trial comparing the effectiveness of two surgical treatments for a     condition associated with lumbar spinal stenosis called degenerative lumbar     spondylolisthesis. Both treatments are currently used, but individual surgeons use different     selection criteria for each treatment and use the procedures at different rates. The two     procedures are decompression with fusion (the most common surgical procedure for     spondylolisthesis) and midline-sparing decompression alone (which is also a standard     treatment, but is not as widely used for treating spondylolisthesis). The investigators plan     to collect the evidence on the following:        1. The feasibility of the trial protocol, and        2. Preliminary data on the effectiveness of each treatment.   "
71599|NCT02348580|"     The study uses experimental methods to evaluate the effectiveness of an educational     intervention in Rwanda. The intervention, designed by Aflatoun and AMIR, involves training     teachers on the use of active-learning methods to implement a social and financial education     curriculum with students in primary and secondary schools. Teachers then implement the social     and financial curriculum with students in order to improve their personal, social, and     financial competencies.      Teacher training will take place in November-December 2013 and the curriculum implementation     will be evaluated in the 2014 school year.      The study will examine the following hypotheses:        1. Did teachers use of active learning methods in class increase due to the training          received?        2. Did students' levels of engagement and on-task behaviour increase as a result of the          intervention's pedagogy and content?        3. Did the following competencies of students improve due to the intervention?             1. Self-efficacy             2. Social skills             3. Financial literacy             4. Planning attitudes             5. Savings attitudes             6. Savings behavior             7. Entrepreneurship        4. Did the intervention change student's pass rates on the primary six (P6) and secondary          three (S3) final examinations for the classes in which it was implemented?        5. Did the intervention change student drop out rates in the classes which it was          implemented?   "
71612|NCT02348411|"     The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided     focused ultrasound thermal ablation of a designated area in the brain of patients suffering     from medication-refractory MDD, using the ExAblate transcranial system.      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the     targeted tissue. For MDD Patients: one or more thermal lesion will be created on Bilateral     Anterior Limb of internal Capsule.      The treatment begins with a series of standard diagnostic MR images to identify the location     and shape of target to be treated. The ExAblate computer uses the physician's designation of     the target volume to plan the best way to cover the target volume with small spots called     sonications. These treatment spots are cylinder shaped. Their size depends on sonication     power and duration. During the treatment, a specific MR scan, which can be processed to     identify changes in tissue temperature, provides a thermal map of the treatment volume to     confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,     and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing     1000-element phased array transducer) positioned above the subject head. The ExAblate     transcranial system also includes means to immobilize the subject head, cool the interface     water, and software for CT analysis and phase correction computation.      After informed consent and screening, eligible subjects will proceed to the treatment. All     subjects will be followed at Day 1, 7 days, 1 month , and 6 months . At follow up visits,     patients will be evaluated for general health, neurological changes (including MMSE exam),and     efficacy measurements as well as for device/procedure related adverse events that may have     occurred during the follow-up period. Six (6) month follow up visit will also include Full     Battery Cognitive/Neurological Testing   "
71600|NCT02348567|"     Introduction: Accreditation programmes for healthcare systems have been implemented in more     than 70 countries to stimulate high-quality organisational performance. Several Danish     healthcare institutions are covered by the Danish Healthcare Quality Programme (DDKM) and all     Danish public hospitals have been accredited according to the DDKM since 2010.      The dates of each survey are currently being announced 8-10 months beforehand. Announcing     surveys has been criticised for creating an arranged reality. It has therefore been     suggested that a national intervention be conducted to evaluate the effect of unannounced     hospital surveys.      Methods and analysis: All public somatic and psychiatric hospitals in Denmark (n=30) were     invited to participate in the trial. Twenty-three hospitals (77%) (3 university hospitals, 5     psychiatric hospitals, and 15 general hospitals) agreed to participate and to be randomised     to one of the trial clusters. Eleven hospitals will receive announced surveys (control group)     and 12 hospitals will receive unannounced surveys (intervention group).We hypothesise that     hospitals receiving unannounced surveys will be rated as less successful than hospitals     receiving announced surveys, defined as meeting less compliance with accreditation standards     and performance indicators. Nine experienced surveyors employed and educated by The Danish     Institute for Quality and Accreditation in Health Care (IKAS) will be responsible for     conducting the surveys according to an abbreviated version of the current Danish periodic     survey. The outcome is compliance with indicators reflecting organisational performance.     Compliance will be analysed using logistic or linear regression analysis with random effects,     contingency tables, and Pearson's chi-squared test or Fishers exact test, whichever is most     appropriate.      Ethics and Dissemination: This trial is pending ethics approval from Research Ethichs Comite     for North Denmark Region. The findings from this randomised controlled trial will be     disseminated through peer-reviewed journals, national and international conferences and will     be utilised as health care political decision making for the future national accreditation     programme. In addition, the results will facilitate to validate the effect of unannounced     hospital surveys; given the issues of currently meeting an arranged reality during hospital     surveys, this seems extremely desirable.   "
71601|NCT02348554|"     The aim of this study was to validate functions for estimating energy expenditure in     controlled and free-living conditions. This method was based on accelerometry data acquired     from smartphones worn in a trouser pocket. The developed functions have been compared to the     estimations provided by three research devices named Fitmate, Armband and Actiheart.   "
71602|NCT02348541|"     Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.   "
71603|NCT02348528|"     CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus     low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who     participated in Study CC-5013-MM-021. For subjects who remained progression free under Rd     treatment of Study CC-5013-MM-02 1, this LAP offers the option to continue lenalidomide     treatment for subjects who have shown therapeutic benefit.   "
71604|NCT02348515|"     Recent evidence of a potential role for cardiac progenitor cells (CPCs) in cardiac repair and     the discovery of a vasoprotective axis of the renin-angiotensin system (RAS) offer such     breakthroughs. Investigators have observed that an imbalance in the vasoprotective axis     {angiotensin converting enzyme 2 (ACE2)/angiotensin-(1-7) [Ang-(1-7)]/Mas receptor} and the     vasodeleterious axis [angiotensin converting enzyme (ACE)/angiotensin II (AngII)/AngII type 1     receptor (AT1R)] of the RAS within the CPCs affects their functionality and regenerative     potential. Investigators believe that restoring the balance between these two axes of the RAS     is essential to improve CPC function and enhance their reparative capabilities. These     observations have led to the hypothesis that genetic modification of CPCs by overexpression     of ACE2/Ang-(1-7) will enhance their reparative function and improve their potential to     attenuate myocardial ischemia-induced cardiac damage.   "
71605|NCT02348502|"     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of     cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be     the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and     the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon     treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring     good long term outcomes in patients with chronic hepatitis B. it was not clear whether     patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained     viral response and the state of HBsAg level≤100 IU/ml.   "
71606|NCT02348489|"     To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously     untreated AML who are not considered candidates for intensive remission induction     chemotherapy.   "
71608|NCT02348463|"     Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was     conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy     could reduce the risk for preterm delivery.      Women were screened for bacterial vaginosis during the first visits at the maternal health     care unit with a vaginal sample that were taken by the midwife or by herself. After the     vaginal samples was air dried it was sent to the gynaecological department and was     investigated using Hay/Ison classification. Eligible women were those who had lived in     Skaraborg and delivered at Skaraborg hospital.   "
71609|NCT02348450|"     This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP     and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer     and to explore the reasonable first-line therapy for Chinese population. An open-label,     multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio     with an estimation of 308 eligible participants.   "
71611|NCT02348424|"     This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal     pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary     objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical,     seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.   "
71613|NCT02348398|"     The goal of this clinical research study is to learn if the combination of topotecan and     pazopanib can help to control recurrent cervical cancer. The safety of the study drug     combination will also be studied.   "
71614|NCT02348385|"     The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco     smokers and nonsmokers.   "
71723|NCT02346955|"     The purpose of this study is to evaluate the safety and tolerability of humanized IgG4     (kappa) isotype monoclonal antibody against CEACAM1 (CM-24 [MK-6018]), administered     intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in participants     with selected advanced or recurrent malignancies. Escalating multiple doses will be evaluated     to determine the recommended dose for Phase 2 clinical studies.   "
71615|NCT02348372|"     GSK1278863A is a novel small molecule agent, which stimulates erythropoiesis through     inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is     being developed for the treatment of anemia. This study, PHI115385, will be the first     administration of GSK1278863A to Japanese subjects to investigate the safety, tolerability,     pharmacokinetics, and pharmacodynamics of single oral doses in healthy Japanese adult     subjects. Healthy Caucasian adult subjects will be included in order to compare     pharmacokinetics of GSK1278863A and its metabolite(s), and pharmacodynamics of GSK1278863A.   "
71616|NCT02348359|"     The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of     vision loss due to wet AMD.   "
71617|NCT02348346|"     Environmental cleanliness As antimicrobial resistance is a major and overall deteriorating     public health problem international cooperation is necessary. Continued progress is needed to     implement and improve programmes for the prevention and control of antimicrobial resistance     and HAIs.      Environmental cleanliness might be one of the most important initiatives to reduce HAIs.     Hospital surfaces are heavily contaminated with bacteria with the highest numbers on surfaces     closest to the patients. Bed rails, nurse call buttons, curtains, towel dispensers, door     handles, sinks, floors, clinical information stations, medical devices, stethoscopes, staff     toilets etc. Actually, general hospital wards and Intensive Care Units are loaded with an     abundance of potential pathogens 8,9,10. Surviving days, weeks or even months in the     environment 11. Colonizing patients with bacteria from the hospital environment and getting     HAIs or even die.      As most ventilator-associated pneumonias (VAPs) are the result of nosocomial microorganisms     the environment plays an important role in the acquisition of pathogenic bacteria by     contaminating health care workers hands and equipment 12,13. Furthermore, ICUs and wards     struggle with colonized patients with ESBL-bacteria from sinks eventually leading to dead or     outbreaks of group A streptococcus infections from contaminated curtains 14,15.      As key healthcare-associated pathogens have the capacity to persist for weeks to months on     hospital surfaces indirect transmission is a serious threat, especially as antimicrobial     resistance increases. Hospitalization in a room in which the previous patient had been     colonized or infected with nosocomial pathogens (e.g. MRSA, VRE, multidrug-resistant     Acinetobacter, Pseudomonas or C. difficile) has been shown to be a risk factor for     colonization of infection with the same pathogen for the next patient16. Furthermore, the     most important risk factor for hand and glove contamination of healthcare workers with     multidrug-resistant bacteria has been demonstrated to be positive environmental cultures 17.     To decrease the frequency and level of contamination of environmental surfaces the Centre for     Disease Control and Prevention recommends routine disinfection of medical equipment and     environmental surfaces to prevent the spread of potential pathogens through the hospital ward     or ICU 18. Improved room cleaning has shown to decrease the risk for MRSA, VRE and C.     difficile acquisition. Unfortunately, environmental cleaning is frequently inadequate. Less     than 50% of hospital room surfaces are adequately cleaned and disinfected even by     environmental services personnel. Environmental services personnel have low wages, are under     time pressure to clean rooms quickly with high turn-over rates of patients. Novel materials     and cleaning technologies have been developed as ultraviolet germicidal irradiation (UVGI) or     hydrogen peroxide vapor (HPV). However, both technologies are expensive and can just be used     for terminal cleaning and not during routine daily care 16. Self-disinfecting surfaces may     overcome these problems. Once applied antimicrobial surfaces will continuously reduce the     bioburden of nosocomial pathogens preventing transmission and decrease HAIs.      MVX One of these self-disinfecting products is MVX. MVX contains titanium dioxide which by     the use of nanotechnology is now available for use in the health sector. Working as a     photocatalyticum it generates, in the presence of light, hydroxy radicals and oxygen radicals     for at least five years after coating hospital surfaces (durability test TUV Rheinland).     Laboratory tests show that MVX is effective in killing bacteria, viruses and fungi (see     attachment 1 for summary test results).      The positive results reported on the effects of MVX from laboratory evaluations still have to     be confirmed in the clinical setting. After getting the CE-marking Gelderse Vallei Hospital     in Ede, the Netherlands, will be the first hospital in Europe to study the efficacy of MVX in     the Intensive Care Unit (ICU).   "
71618|NCT02348333|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male     adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each     step. After follow-up examination in the step of lower dose, the next dose is administered.   "
71619|NCT02348320|"     This is a phase 1 open-label study to evaluate the safety and immunogenicity of a     personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines will     be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that     personalized polyepitope DNA vaccines will be safe for human administration and capable of     generating measurable CD8 T cell responses to mutant tumor-specific antigens.   "
71620|NCT02348307|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in     fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in     each step. After follow-up examination in the step of lower dose, the next dose is     administered. The effect of food on PK/PD of FYU-981 is also investigated.   "
71621|NCT02348294|"     1. The objective of this study is to acquire knowledge about the development of reactive          hyperaemia and inflammatory responses of the skin after shear- force and pressure          loading. We want to investigate if patients with diabetes type 2 will develop more skin          damage, because of a decreased microvascular function.        2. The second objective of this study is: to investigate if the cytokine production of the          skin is increased in patients with type 2 diabetes with a history of Charcot          osteoarthropathy in comparison with patients with neuropathy without a history of          Charcot osteoarthropathy.      The participant is asked to put his left arm on a support cushion. Then we mark an area of     2.5 cm x 3 cm with a permanent marker at the plantar aspect of the left fore-arm and the     adhesive side of a Sebutape is placed within this area for collection of IL-1α/ total protein     concentrations in a non- loaded situation (event 1) for two minutes. Second, we measure the     cutaneous blood cell flux within the borders of the marked area with a Laser doppler.     Finally, we measure the erythema index in this area with a colorimeter. Then we place the     shear- pad over the marked area we apply 9,8 Newton (N) pressure with 19 N shear- force for     half an hour. After this period a new Sebutape is placed for two minutes, followed by     cutaneous blood cell flux and the erythema index measurement within the borders of the marked     area. We repeat these measures after 15 minutes, 30 minutes, 45 minutes and 60 minutes, At     the same time we performed the same experiment at the right arm, but instead of loading this     arm with shear- force and pressure, we apply only 9,8 N pressure at this arm. The same     measures with the sebutape, laser doppler and colorimeter are done before and after loading     of the skin. The measures are repeated at 15 minutes, 30 minutes, 45 minutes and 60 minutes.   "
71622|NCT02348281|"     This prospective, single center, phase II study is to evaluate the efficacy and safety of     bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative     breast cancer (mTNBC) patients.   "
71623|NCT02348268|"     Mechanical neck pain is a musculoskeletal disorder usually associated with work absenteeism.     Myofascial release therapy (MRT) is currently under development and has the treatment of     mechanical neck pain as one of its main focal points. However, there is a paucity of studies     reporting its effectiveness. For that purpose a randomized single-blind parallel group study     was designed to compare the effectiveness of MRT with manual therapy (MT) for treating     occupational mechanical neck pain. The sample (n=59) was randomly assigned to two therapeutic     intervention programs. Group I patients were treated with MT and Group II patients were     treated with MRT. Variables studied were intensity of neck pain, cervical disability, quality     of life (QoL), craniovertebral angle and ranges of cervical motion.   "
71747|NCT02346643|"     11-SMI-2013 is a post market, observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     intractable, chronic pain   "
72562|NCT02335970|"     This study evaluates the effect of a training intervention after thoracoabdominal resection     of the oesophagus. Half of the patients scheduled for thoracoabdominal oesophagus surgery     were randomized to an intervention group while the other half a control group.   "
71624|NCT02348255|"     This phase II trial studies the safety of NovoTTF-100A in combination with bevacizumab and     carmustine and to see how well they work in treating patients with glioblastoma multiforme     that has returned for the first time. NovoTTF-100A, a type of electric field therapy,     delivers low intensity, alternating wave-like electric fields that may interfere with     multiplication of the glioblastoma multiforme cells. Monoclonal antibodies, such as     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in     chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving NovoTTF-100A together with bevacizumab and carmustine may be an effective     treatment for glioblastoma multiforme.   "
71625|NCT02348242|"     60% of the patients hospitalized in intensive care and sedated suffer from insufficient     inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to     57%). The prevention of such corneal damage can be done using several techniques (artificial     tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never     been compared in a rigorous study. Therefore it is not yet possible to determine an     evidence-based strategy to prevent corneal damage in intensive care patients.      This study aims at assessing the efficacy of primary prevention of corneal lesions in     intensive care patients, in order to elaborate an evidence-based nursing protocol.   "
71626|NCT02348229|"     The investigators designed a prospective randomized, controlled clinical trial then recruited     149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73)     and a conventional pathway group (n=76). Surgical technique in both groups was same     laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included     clinical parameters and serum indicators.   "
71627|NCT02348216|"     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell     therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).   "
71628|NCT02348203|"     This randomized phase II trial studies the effects of aspirin and zileuton on genes related     to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to     tobacco use and may be useful in preventing lung cancer in current smokers.   "
72105|NCT02342145|"     The purpose of this study is to evaluate the basiliximab for prevention of graft-versus-host     disease in unrelated allo-genetic hematopoietic stem cell transplantation for thalassemia     major. The objective was to evaluate the effect and safety of basiliximab for acute     graft-versus-host disease.   "
71629|NCT02348190|"     The overall objective of the current proposal is to strengthen the putative link between FFA     induced insulin resistance and atherosclerotic vascular disease (ASVD). To this end, the     investigators will test the following hypotheses: 1) that FFA induced activation of protein     kinase C βII (PKC β II) and δ and other serine kinases such as IκB kinase (IKK) in human     muscle is associated with a decrease in insulin stimulated tyrosine phosphorylation of the     insulin receptor substrate-1 (IRS-1) and of IRS-1 associated phosphatidylinositol 3 (PI3)     kinase; 2) that these changes precede the development of insulin resistance; 3) that the     decrease in IκB-α results in activation of nuclear factor κB (NFκB) and the expression of     adhesion molecules and cytokines; 4) that PKC and IKK are involved in producing insulin     resistance and activation of the IκB/ NFκB pathway and lastly 5) that the same mechanisms     operative in healthy volunteers are also operative in patients with T2DM.The investigators     will test these hypotheses in normal (current) and diabetic volunteers (previously completed)     . Euglycemic-hyperinsulinemic clamps will be performed with and without co-infusion of lipid     plus heparin (to raise FFAs) and by obtaining serial muscle and fat biopsies and blood     samples will be obtained for measurement of substrates, hormones, enzymes and metabolites.   "
71630|NCT02348177|"     The purpose of this study is to determine the lopinavir levels in blood of HIV and TB     infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin     containing TB regimen and its safety.   "
71631|NCT02348164|"     The goal of the research study is to measure and compare the absorption of equivalent amounts     of beta-cryptoxanthin and Iycopene provided in citrus fruit. The investigators want to     determine whether adults absorb beta-cryptoxanthin to a greater extent than lycopene, when     both are supplied in comparable citrus fruits.   "
71632|NCT02348151|"     It is still not clearly known whether doing the walk test in a course is different from doing     it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in     this study, we will have an alternative for this test in places where there is not enough     room, benefiting the assessment of COPD patients' functional capacity. In the literature,     there are still some controversies about performing the test on a treadmill or in a corridor     and whether there is interference with the distance walked. Our hypothesis is that there is     no interference with the distance walked, and thus we have one more option to perform the     test in case there is no 10-meter corridor available.   "
71633|NCT02348138|"     The main purpose this study is to analyze the effects of isometric handgrip training on     cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under     anti-hypertensive medication, will be selected and randomly distributed into three groups:     home-based isometric handgrip training (HBT), supervised isometric handgrip training (ST) and     control group (CG).Subjects assigned to the HBT and ST will train three times per week for a     total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min     isometric contractions (using alternate hands) at 30% of maximal voluntary contraction.     However, the subjects of the HBT group conduct the training without daily supervision.     Subjects randomized to the CG will be encouraged to increase the level of physical activity     and make healthy eating, without, however, receive specific recommendations.Baseline and     after 12 weeks of intervention, the following cardiovascular risk indicators will be     obtained: blood pressure, arterial stiffness, cardiac autonomic modulation, vasodilatory     capacity and oxidative and inflammatory stress markers, in addition to microalbuminuria. For     data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be     applied for within and between groups comparison. If the premises of this test are met. The     level of significance that will be adopted is p<0.05.   "
72978|NCT02330549|"     A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of CVC to be     conducted in approximately 50 adult obese subjects (BMI ≥ 30 kg/m2) with prediabetes or type     2 diabetes mellitus and suspected NALFD.   "
71634|NCT02348125|"     In this study, 50 children between 3 and 12 years old with formally diagnosed autistic     spectrum disorders (ASD) and also having significant mitochondrial dysfunction will be     treated for a 3 month period with the Mitochondrial Cocktail, a combination of specific     nutritional supplements and metabolite intermediates (including anti-oxidants) and bio-energy     substrates. A series of neurological and psychological evaluations will be conducted by     trained evaluators/clinicians to evaluate both the severity and the clinical presentation of     the ASD/mitochondrial dysfunction with each subject at baseline prior to treatment, after the     3 month treatment and again at 6 months, after another 3 month non-treatment period. In     addition, laboratory investigations will be conducted at the same time-points to assess the     mitochondrial dysfunction and cellular biomarkers thought to be associated with autistic and     mitochondrial disorders. These investigations will include the analysis of samples of blood     and cheek/buccal swabs collected from each child to assess select biochemical markers of ASD.     The Mitochondrial Cocktail treatment will be administered at home once a day continuously for     a total of 3 months. All the children in the study will be treated with the same     Mitochondrial Cocktail (an open label study).   "
71635|NCT02348112|"     The aim of this postmarket study is to compare the safety and effectiveness of the Altis     Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36     months.   "
71636|NCT02348099|"     This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as     detected with ultrasound and its impact on glycemic variability.   "
71637|NCT02348086|"     The purpose of this study is to determine the impact that treatment with a cellular     concentrate derived from an individual's own fat, known as the stromal vascular fraction     (SVF), has on pain and functionality in people with rheumatoid arthritis (RA). SVF contains     multiple cellular components, including stem cells, with both regenerative and     anti-inflammatory properties. This therapy has shown promise for ameliorating the symptoms of     RA. This study is designed to evaluate changes in pain and functionality in individuals with     RA for up to 12 months following SVF treatment.   "
71651|NCT02347904|"     In this prospective single arm study the investigators will assess the feasibility of S-1 and     Oxaliplatin as adjuvant treatment in patients with esophageal cancer.      The primary objective is to assess the feasibility of administering adjuvant S-1 and     Oxaliplatin (SOX) in patients with esophageal cancer after neoadjuvant chemoradiotherapy with     paclitaxel and carboplatin and esophagectomy. Primary end point is the percentage of patients     completing the preplanned number of 6 cycles of SOX.   "
71652|NCT02347891|"     The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance     therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with     standard of care. This is a multicentre double-blind, placebo-controlled trial.   "
71638|NCT02348073|"     Our project aims to develop a new therapeutic approach in epilepsy-associated attention     disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids,     containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a     phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA     supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children     with epilepsy. Secondary objectives include:        -  To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.        -  To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid          profiles.        -  To assess the tolerance of a supplementation of PS-Omega 3.        -  To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.        -  To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,             1. on attention disorders in children with epilepsy,             2. on quality of life,             3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects               aged 6- 16 years, suffering from epilepsy (any type) and attention deficit               hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V               criteria in 12 clinical sites in France.   "
71639|NCT02348060|"     The purpose of this study is to determine the impact that treatment with a cellular     concentrate derived from an individual's own fat, known as the stromal vascular fraction     (SVF), has on the quality of life of people with chronic obstructive pulmonary disease     (COPD). SVF contains multiple cellular components, including stem cells, with both     regenerative and anti-inflammatory properties. This therapy has shown promise for     ameliorating the symptoms of COPD. This study is designed to evaluate quality of life changes     in individuals with COPD for up to 12 months following SVF treatment.   "
71640|NCT02348047|"     Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode,     on intubated, ventilated and sedated patients, during their secondary transfer from an     hospital to another, by a SMUR team.   "
71641|NCT02348034|"     The study will explore the ability of negative pressure wound therapy (Prevena dressing) to     reduce post operative superficial surgical site infection rate in elective colorectal     surgery. Half of the participants will receive Prevena dressing on closed incision     immediately after the operation while other half will receive conventional surgical dressing.   "
71642|NCT02348021|"     Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients     in Japan. All patients will receive a DCS and will be followed for 2 years.   "
71643|NCT02348008|"     This is an open label, multi-institutional, single arm study of dose escalation phase Ib     cohort, followed by a phase II cohort of anti-PD-1 antibody MK-3475 in combination with     bevacizumab. No randomization or blinding is involved.   "
71644|NCT02347995|"     Stroke survivors experience severe muscle wasting during the chronic phase of recovery, with     implications for strength, function and general health. Although resistive exercise training     effectively combats this problem, it is unknown whether sub-optimal protein intake limits the     observed gains in skeletal muscle growth. Skeletal muscle adaptations may occur when     resistive training (RT) is combined with nutritional therapy in the form of post- exercise     protein consumption. This study would be the first to directly compare RT+protein     supplementation to RT+placebo (same calories as protein supplement) in those with chronic     hemiparesis caused by stroke, providing evidence-based rationale for combination therapy in     the clinical care of this population.   "
71645|NCT02347982|"     This study will compose a national database of cardiovascular diseases' risk factors,     concomitant diseases and the drug usage among the elderly patients in Turkey.   "
71647|NCT02347956|"     Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the     tumor is the only curative treatment for gastric cancer. However, surgical procedure     accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma     and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was accepted     as safe and effective alternative to open gastrectomy. Furthermore, reduced port and single     port laparoscopic gastrectomy are considered to minimize the surgical trauma during     gastrectomy. However, limitations of laparoscopic approach using reduced port includes     unergonomic posture of surgeon, physiologic tremor and collision of instruments. To overcome     these limitations, robot surgery using novel single-site technology enabled surgeons to     perform the surgical procedure reducing the number of trocar from three to one for insertion     of scope and two robotic arms. Previously, successful application of single-site technology     for cholecystectomy and hysterectomy were reported. The aim of this study is to validate the     safety and feasibility of reduced port robotic distal gastrectomy using single-site     technology for the surgical treatment of gastric cancer.   "
71648|NCT02347943|"     This study evaluates long-term safety and effectiveness of primary sinus surgery in a     real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute     rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using     commercially available sinus instrumentation (e.g. sinus balloon catheters, powered     microdebriders, manual instruments).   "
71649|NCT02347930|"     Establish an integrated evaluation system of ultrasound technology for the prognosis of acute     kidney injury, and in order to achieve non-invasive, reliable early diagnosis gold     standard. Set up collabration with the expert in National Cheng Kung University Medical     Center of Taiwan who did a lot of excellent work in basic research of prevention the     progression of acut kidney injury. Study the experience about prevention progression of     kidney disease in clinical and basic field. Establish cooperation with the professional in     Hong Kong University of Science and Technology. To set up the system of natural products     research and assess the Astragalus medicinal value.   "
71650|NCT02347917|"     This is an open-label, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed     and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM).   "
71672|NCT02347618|"     The purpose of this study is to determine whether a short-course of stereotactic body     radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and     well-tolerated.   "
71653|NCT02347878|"     Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and     often debilitating syndrome, which was reported to occur in about 40% patients who received     lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although     some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent     meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies     have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an     important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor     (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the     severity of PLPH.   "
71654|NCT02347865|"     The purpose of the study is to describe the characteristics and management of post menopausal     women with osteoporosis treated with Prolia in France, and examine the use of Prolia in     routine clinical practice in France   "
71656|NCT02347839|"     The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed     by adjuvant gefitinib to see how well it works in treating patients with unresectable stage     III NSCLC harboring EGFR mutations.   "
71657|NCT02347826|"     An email questionnaire about subjective satisfaction and discomfort has been sent to 243     patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1     year after treatment.   "
71658|NCT02347813|"     This study is proposed based on our work showing that the diabetes drug Pioglitazone strongly     inhibits growth of tissue cultured squamous cell carcinoma (SCC) of the skin. This occurs at     concentrations readily achievable by oral administration of this drug using doses currently     approved for the treatment of diabetes. In our study, we propose to enroll 40 non-diabetic     adult subjects (18-80 yrs of age inclusive) with a documented clinical history of frequent     occurrence of skin squamous cell cancer to receive Pioglitazone (Actos®,Takeda     Pharmaceuticals). Each subject will receive usual care for all new tumors they develop while     on study (i.e, excision and plastic repair). The study protocol will randomize (1:1) patients     for 6 months of observation followed by 6 months of treatment (group 1) or 6 months of     treatment with drug followed by observation for 6 months (to examine washout effects). The     biopsy specimens collected on and off therapy will be examined to determine if they express     AKR1C3, an enzyme we believe increases resistance of SCC to prostaglandin inflammatory     mediators. We will also examine the histologic grade of the removed tumors and study whether     Pioglitazone treatment can decrease the number of aggressive versus well differentiated     tumors in study patients. This pilot study is designed to detect a statistically significant     change in SCC tumor numbers but is not sponsored by the drug manufacturer. The data obtained     will not be used to effect a change in the product label.   "
71659|NCT02347787|"     This is a multi-center randomized controlled trial comparing the effectiveness of community     health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low     socioeconomic status to improve their health outcomes.   "
71660|NCT02347774|"     This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational     eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease     (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014)     guidelines.   "
71661|NCT02347761|"     This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational     eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease     (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014)     guidelines.   "
71789|NCT02346097|"     The purpose of this study is to investigate if optimal electrical resynchronization     achieved by targeting left ventricular lead placement to the myocardial region with the     latest electrical activation combined with post-implant pacemakersettings for narrowing the     paced QRS width causes an excess improvement in the pumping function of the heart (the left     ventricular ejection fraction) in Cardiac Resynchronization Therapy (CRT)   "
71662|NCT02347748|"     Background: Pre anaesthesia anxiety in children is a strong predictor of postoperative     behavior challenges and outcomes. In addition, intra-operative stress can precipitate     post-traumatic stress symptomatology. Comfort Talk, consisting of rapport, relaxation, and     reframing of potentially stressful experiences, applied pre-operatively in script form, has     been highly successful in alleviating anxiety and positively affecting procedural outcomes in     adult patients undergoing interventional procedures. No published literature exists     evaluating its' impact in paediatric cardiac catheterization. Purpose: To investigate the     impact of comfort talk on the level of pre-induction anxiety, procedural and recovery     experience, as well as short-term post-procedural behaviour and satisfaction after discharge     in pediatric patients undergoing cardiac catheterization procedures. Design: Prospective     randomized, double blind controlled trial. Participants: 160 children, ages 7-18 years,     having a cardiac catheterization procedure under general anaesthesia. Intervention: Group A     will be read a pre-procedure comfort talk script in the pre-procedure work-up area; Group B     will be read a pre-extubation (before the breathing tube is removed) script ; Group C will be     read a pre-procedure plus a pre-extubation script; Group D will not be read any script. All     groups will be treated according to the standard of care approaches usually provided for     anaesthesia, catheterization, and recovery. Outcomes: We will compare the effect of the     script strategy on preoperative anxiety. Procedural and recovery measurements will include     room time in the catheterization suite, time to discharge from the recovery room; drug use,     vomiting, rebleeds, and cardiorespiratory stability. Postoperative behaviour will be assessed     by questionnaire. Postoperative anxiety and pain will be secondary outcome measures using     queries on 0-10 verbal self-report scales Hypotheses are:        1. Patients being read a preoperative Comfort Talk script will experience less anxiety          prior to anaesthesia induction.        2. The reduction of anxiety prior to induction is associated with better immediate and          short-term recovery outcomes.        3. Patients being read a pre-extubation script will recover better than controls.        4. The combination of a pre-procedure script and a pre-extubation script will have the          greatest positive effect on physical and emotional well-being in the immediate recovery          period and at short term follow-up.   "
71673|NCT02347605|"     The purpose of this study is to determine if changing the timeframe (relative to cue     presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms     of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In     this cross-over study, all subjects attend three laboratory sessions at which either nicotine     lozenge or placebo is given prior to presentation of smoking cues or after presentation of     smoking cues. The order in which the three conditions will be presented are randomized.   "
71674|NCT02347592|"     The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more     expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The     investigators used these catheters in parallel for several years. To clarify what catheter     has least problems the investigators performed a comparative study to clarify if outflow     problems differed between these catheters.   "
71675|NCT02347579|"     Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients     experience dramatic decline of overall well-being, despite the absence of any apparent     physical cause. The main symptoms are hypersensitivity to pain (hyperalgesia) and     experiencing normal tactile stimulation as painful (allodynia) in the absence of peripheral     nerve damage. The debate on the aetiology of CRPS-I is still open.      The therapy offered to CRPS-I patients is diverse and can involve invasive and non-invasive     interventions. Current (inter)national guidelines recommend physiotherapy as the best     non-invasive treatment for rehabilitation. Recently, cognitive and behavioural Graded     Exposure in Vivo (GEXP) therapy aimed at reducing pain-related fear was found to be effective     (De Jong et al. 2005), and more effective than standard physical therapy (ReMOVE study,     articles in preparation). By reducing pain-related fear EXP might reconcile motor output and     sensory feedback.      Another type of pain is lower back pain (LBP), which affects 70% to 85% of general     population, but usually heals within 12 weeks in 90% of patients. The rest of the patients     suffer from intractable, chronic LBP despite no evident organic abnormality. Research shows     that also in these patients cognitive and behavioural aspects of pain are important and     related to physical performance and self-reported disability (Vlaeyen et al., 2000). Several     studies have demonstrated the success of GEXP in this patient group: GEXP resulted in     improvements in pain-related fear, catastrophizing, performance of daily relevant activities,     and in pain intensity (Leeuw et al., 2008).      This study aims to investigate the effect of GEXP on brain regions involved in the processing     of harmless tactile stimuli in CRPS-I and CLBP patients, as well as its effect on tactile     discrimination thresholds. We hypothesize that GEXP will induce 1) an improvement of tactile     discrimination thresholds, 2) a functional reorganization of primary and secondary     somatosensory cortex (in regions related to the affected limb in CRPS-I; and to the back in     LBP), 3) changes in activation of emotional brain circuits during non-noxious stimulation, 4)     changes in resting state connectivity between emotional and sensory brain areas, 5) changes     in measures reflecting white matter integrity. No systematic changes are expected in the     healthy controls.      Patients diagnosed with CRPS-I and CLBP will participate in a Magnetic Resonance Imaging     (MRI) experiment. In this observational study, we examine the effects of GEXP treatment that     all patients receive as part of usual care. Anatomical as well as diffusion-weighted and     T2*-weighted (Blood oxygenation level dependent) MR images will be acquired. The study has a     3x4 split plot design with group (CRPS-I patients and CLBP receiving GEXP treatment / healthy     controls) as between-subjects variable and time (pre-, during, post-treatment and follow-up)     as within-subject variable.   "
71663|NCT02347735|"     Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide,     estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the     predominant curative treatment type for colorectal cancer, but has a major impact on the     patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the     development of frequently observed and severe postoperative complications. The most important     complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of     8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%.     Even though many attempts have been made to reduce the incidence of this dreaded     complication, none of these interventions have been successful so far. Despite proper patient     selection and improvement in surgical techniques, the percentage of AL has been stable for     years.      Objectives: To investigate whether recently identified patient-specific factors can predict     the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal     cancer.      Study design: Prospective observational study Study population: Adult colorectal cancer     patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL     within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample,     I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood,     VOCs in exhaled air, COX-2 & MBL polymorphisms in buccal smear, L3-index & atherosclerosis     measurements on CT-scans, SNAQ & MUST scores   "
71664|NCT02347722|"     The purpose of this study is to evaluate existing biomarkers and see if they can be used to     accurately diagnose the etiology of heart failure.   "
71665|NCT02347709|"     The primary purpose of this study is to determine the degree of loss of epidermal nerve     fibers near a foot wound in patients with diabetic foot ulcers. The secondary purpose will be     to determine whether the degree of epidermal nerve fiber loss, the clinical examination,     nerve conduction studies or the molecular profile correlates with appearance of lower     extremity ulcers in patients with diabetes.   "
71666|NCT02347696|"     This study aims to evaluate the effect of two programs of different intensity level of     physical activity, of low glycemic index Mediterranean Diet and of the interaction of both,     on NAFLD score and on the lipid composition of the erythrocyte membrane.   "
71667|NCT02347683|"     The optimal timing to measure thyroglobulin(Tg) after thyroidectomy is unknown in patients     with thyroid cancer. The ATA and NCCN guidelines are not specific on optimal timing of Tg     levels in post-op state and suggest anywhere between 2-12 weeks.      Hypothesis - Post -op Tg nadirs at 6-8 weeks .      Primary Objective -Determine optimal timing of post thyroidectomy Tg nadir, so to determine     the most accurate time to check post operatively.      Secondary Outcome - Determine factors that will affect Tg levels post operatively.      All adults age 19 and above already planning to undergo near total /total thyroidectomy for     reasons unrelated to the study.      Measure Tg , Tg Ab and TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, and 3 month in     patients with pathology confirmed benign disease.      Measure Tg , Tg Ab , TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, 3 month, 6 month, and 12     month in patients with thyroid cancer.   "
71668|NCT02347670|"     The project aims to determine the effectiveness of a patient-centered health care delivery     system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over the     course of 1 year, a 6-person team comprised of one attending physician; project managers and     community health educators, ophthalmic technician, and patient navigators will complete a     baseline visit, baseline assessment and 2-3 follow-up visits. The patient navigator will     assist participants in community groups and a portion of the office-based participants with     scheduling follow-up appointments   "
71669|NCT02347657|"     This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter     study in people with CF who are homozygous for the F508del CFTR mutation.   "
71790|NCT02346084|"     The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of     maraviroc gel following rectal and vaginal administration. The study also includes oral     exposure to maraviroc.   "
71670|NCT02347644|"     The objective of this study is to explore the efficacy of brief motivational interventions     (BMIs) for treatment of youth with alcohol and other drug problems after at least 3 months.     The results of previous studies indicate that brief interventions for unhealthy alcohol use     have been shown to be effective in primary care settings, with most studies focusing on     adults and few studies focusing on youth. To date, no BMI studies have been conducted in the     Ukraine among youth with alcohol or other drug use. Of particular concern are emerging adults     ages 18-25 who may be at particularly high risk for alcohol problems given historical events     related to the fall of the Soviet Union and the subsequent economic down turn.      This study will evaluate the efficacy of BMI by comparing BMI and no BMI conditions among two     samples of youth screening positive on the prescreen survey for risky drinking. The subject     pool will come from the Psychoneurological Department: the first location is located in the     Railway Clinical Hospital, its clinical base, and the second in classes in the department at     Kiev National Medical University.      The total sample of 120 will be broken down to 1.) 60 patients from Railway Clinical     Hospital; and 2.) 60 students from Kiev National Medical University. Participants will be     stratified by recruitment site and randomized to condition: BMI and control, with follow-up     assessment at 3 months. In addition to being the first of study to evaluate the efficacy of     BMI on substance use problems among youth in Ukraine, this study will examine BMI     intervention processes in relation to alcohol and other drug outcomes. Findings will inform     research and clinical practice to enhance early identification and prevention of problematic     alcohol use trajectories among emerging adults   "
71671|NCT02347631|"     This is a prospective, single center, randomized, bilateral crossover, dispensing clinical     trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of     corneal epithelium over two months of daily wear compared to wear of a control high oxygen     permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to     correlate these changes with alterations in the lid wiper, tear film and cellular changes at     the limbus. The total proposed duration of this study is 12 months to ensure enrollment of up     to 94 established contact lens wearers, with anticipated completion of 84. Data will be     collected at baseline and following 2 months of daily wear for each lens type. Based upon     data from the investigators previous contact lens clinical trials, a 1 month washout period     is required prior to initiating lens wear to eliminate any potential residual solution or     lens effects on the corneal epithelium and restore homeostasis. The study is scheduled to     commence upon Institutional Review Board approval.   "
71676|NCT02347566|"     Patients with Chronic Obstructive Pulmonary Disease are characterised by a sedentary     lifestyle. This contributes to increase the number of hospitalizations and mortality.     Changing this lifestyle is a major objective of the management of these patients. Pulmonary     rehabilitation helps patients to increase their fitness, but modifying a longstanding     sedentary habit is more difficult to achieve. This project aims at modifying patients' long     term physical activity with a physical activity coaching programme. This will help patients     to transform the benefits of pulmonary rehabilitation into a healthier active lifestyle and     contribute to reduce hospitalizations, increase quality of life and survival.   "
71677|NCT02347553|"     It is known that hypoglycaemia affects various domains of cognitive function. One aspect of     cognitive function is 'social cognition', which is our ability to interpret facial     expressions, gestures and speech. It is an approach to understanding human judgement and     behaviour. There is anecdotal evidence for negative behavioural responses such as     aggressiveness and argumentativeness during hypoglycaemia and while research has shown that     hypoglycaemia can cause significant changes in mood, little information exists regarding its     effect on social cognition. It is therefore not known whether hypoglycaemia affects this     aspect of cognitive function but, if it did, it could explain why people with low blood sugar     due to insulin treatment are often resistant to offers of help (for example, they may     misinterpret a friendly gesture as being threatening). Knowledge of this effect of     hypoglycaemia can be used to educate relatives and carers of people with diabetes who may     suffer this problem.      Hypoglycaemia is also known to have an effect on the electrical rhythm of the heart. This is     thought to be secondary to adrenaline secretion during hypoglycaemia which provokes a fall in     the blood level of potassium, a type of electrolyte. Other electrolyte imbalances are known     to predispose to heart rhythm abnormalities or arrhythmias in other situations and it is not     known if the levels of these other electrolytes are affected during hypoglycaemia.      Using specific tests of social cognition and continuous electrocardiographic (ECG)     monitoring, this study aims to find out whether social cognition is affected by an hour of     hypoglycaemia and how hypoglycaemia affects blood electrolyte levels and the     electrophysiology of the heart.   "
71678|NCT02347540|"     This study is a cross-sectional case-control study where classical as well as more innovative     risk factors for CVD will be explored.      In western countries, more women than men die of cardiovascular disease (CVD), making CVD in     women an important public health issue. Misdiagnosis of CVD in women is frequently observed,     posing the clinician for diagnostic and therapeutic dilemmas that can easily result in     inadequate treatment and worse prognosis. Despite these challenges, CVD in women has been     underexposed in scientific research.      Women have gender-specific risk factors like a history of preeclampsia (PE) that contribute     to their risk for CVD. PE complicates 5-10% of pregnancies, recurs in ~25% and is associated     with a 2-4 fold increased risk for CVD. Moreover, pre-symptomatic heart failure (HF) stage B     occurs in 40% of women with a history of PE. HF stage B is thought to precede the development     of the, mortality related, clinical HF stages C and D (structural heart disease in     combination with symptomatic disease). Early detection and tailored intervention of women     with stage B HF decreases progression to the clinical stages and might therefore improve     clinical outcome and cardiovascular related mortality.      Phenotypic presentation of HF is currently split up between systolic HF also called HF with     reduced ejection fraction (HFrEF) and diastolic HF or HF with preserved ejection fraction     (HFpEF). Women more often have HFpEF in contrast to men. Different pathophysiology and     disease progression in women compared to men seems to be an important underlying factor. The     current clinical HF diagnostic tools (e.g. natriuretic hormones and high sensitivity     troponins) fail to identify early changes that prelude adverse cardiac remodelling and HF,     and do not discriminate between HFrEF and HFpEF. Moreover, there are sex-related differences     in biomarker levels for detection of CVD. As a result, clinicians are forced to wait for the     failing heart to become clinically evident before they can intervene. Therefore, there is an     urgent need to assess novel biomarkers that could help select high risk women needing further     follow up and intervention. Biomarkers may not only improve early diagnosis but may also     unravel disease pathways of HFpEF. Especially when combined with measurements of subclinical,     surrogate risk markers.      Objectives        -  To determine the impact of PE on incidence of macro-and micro-vascular dysfunction          reflected by surrogate measures for coronary artery disease (CAD) and HFpEF.        -  To perform a genome wide association study (GWAS) and associate novel biomarker          expression levels with endothelial function, cardiac diastolic function and IMT          measurement.        -  To identify risk factors and surrogate measures for CVD in a) former PE patients without          HFpEF, b) former PE patients with HFpEF and c) healthy parous controls.      Study population Cases: women with a history of PE Controls: women with uncomplicated     pregnancies in the history. Measurements will be performed in clusters at postpartum     intervals of: ½-2, 5-10, 10-15 and 15-30 years. Number of inclusions will be: 425, 350, 282     and 233 for each follow-up group respectively.      Primary endpoints The prevalence of macro- and microvascular dysfunction in former PE     patients. Novel biomarker detection in former PE patients associated with HF in general and     HFpEF in particular.      Secondary endpoints        -  Lifestyle (questionnaire)        -  Cognitive ability (questionnaire)        -  Depression score (questionnaire)        -  Metabolic syndrome (MetS)        -  Arterial endothelial function (Flow mediated dilation (FMD))        -  Intima Media Thickness (IMT)        -  Glycocalyx thickness (by means of the Glycocheck)        -  Venous function (plethysmograph)        -  Electrocardiogram (ECG)        -  Ergometry   "
71680|NCT02347514|"     Community health centers across the US are seeking to address the growing prevalence of     diabetes in adults. The University of Chicago has partnered with the MidWest Clinicians'     Network (MWCN) to conduct a research study to train community health center staff and     providers to implement and sustain diabetes group visits, also referred to as shared medical     appointments, at their health center. The study's aims are to: 1) Develop, conduct, and     evaluate a training program for health center staff to implement a diabetes group visit     intervention in their health center; 2) Assess the implementation of diabetes group visits in     the community health center setting and determine the cost of implementation; 3) Assess the     feasibility and cost of implementing a text-messaging intervention in addition to the     implementation of diabetes group visits in the CHC setting at one health center and 4) Assess     the impact of the diabetes group visits alone and diabetes group visits plus text-messaging     on diabetes process measures, patient outcomes, and patient satisfaction compared to control     patients from the same health center with six months of follow-up once the six-month group     visit program ends.   "
71786|NCT02346136|"     The proposed study will determine whether Tai Chi is an effective and practical intervention     to improve overall function and lower health care costs in an expensive, vulnerable     population of seniors that is more representative of many US communities than those     previously studied. If the results are favorable, our study will also provide the necessary     training and protocol manuals to replicate Tai Chi programs in senior housing facilities     across the nation to help prevent, better manage, and overcome frailty among seniors.   "
71681|NCT02347501|"     The primary purpose of this study is to determine if sitagliptin (Januvia®) improves     psoriasis severity after 24 weeks of treatment in 60 participants with psoriasis who do not     have type 2 diabetes mellitus, and who are due to receive a course of narrowband     ultraviolet-B phototherapy (NB-UVB). The investigators will compare the change in psoriasis     severity in 60 participants treated with both sitagliptin and NB-UVB to 60 participants     treated with NB-UVB alone. Participants will be recruited from two centres and after a 3 week     run-in period will be followed prospectively for 36 weeks. Participants will be stratified by     centre, plasma glycated haemoglobin level (HbA1c), obesity status and previous response to     NB-UVB, after which they will be randomly allocated to Arm A or Arm B. Participants will be     treated with either sitagliptin for 24 weeks and NB-UVB (Arm A), or NB-UVB alone (Arm B).      Both the research participants and the investigators will be aware of the trial arm to which     the research participant has been allocated randomly (open-label study). Research     participants are prohibited from using systemic psoriasis therapy for the duration of their     trial involvement.      Participants will be assessed at 8 study visits over 39 weeks. Participants will complete     questionnaires, have a medical history recorded and physical examination, blood sampling and     skin biopsies taken (in a small number of willing participants at 2 visits).      The following endpoints will be analysed:      Changes in psoriasis severity at 24 and 36 weeks; changes in validated quality of life     scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs,     time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes     in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic     profiles that predicts best response to sitagliptin therapy.      The investigators hypothesize that sitagliptin therapy decreases psoriasis severity.   "
71682|NCT02347488|"     This study aims to test the effectiveness of a novel combined endotracheal tube holder and     bite guard when compared with the current standard of care, tape and an oral airway.   "
71683|NCT02347475|"     This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in     the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in     premature neonates. These changes will be measured in relation to feeding, before and after a     blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing     enterocolitis (NEC) - a condition with significant mortality and long term morbidity.     Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for     planning, studying and implementing risk avoidance and minimization strategies.   "
71684|NCT02347462|"     Bilevel Positive Airway Pressure (BiPAP) is increasingly being reported as an effective and     safe method of respiratory support for children with severe asthma exacerbations unresponsive     to standard therapies and with impending respiratory failure. Much of the evidence base     supporting its use comes from retrospective observational studies, and there is currently a     lack of data from randomized controlled trials to inform this practice.      The investigators hypothesize that the use of BiPAP in children with moderate to severe     asthma exacerbations could reduce the length of hospital stay, need for invasive ventilation,     and use of intravenous bronchodilators. The investigators aim to test this hypothesis by     randomizing children attending the Emergency Department with a moderate to severe clinical     severity score refractory to inhaled bronchodilators to receive either BiPAP in addition to     standard asthma care, or standard care alone.   "
71687|NCT02347423|"     The background of the present clinical trial is the overall aim of the World Health     Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan,     inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price,     needs to be available in low resource third world countries. The intention of the present     phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the     target population and do not decrease the immunogenicity clinically significantly compared to     full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines     according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of     age.      A total of 824 healthy infants will be included in the trial.   "
71688|NCT02347410|"     This study evaluates the safety and effectiveness of the Spineology Interbody Fusion System     (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic     single-level lumbar degenerative disc disease.   "
71689|NCT02347397|"     This is a prospective, randomized, multicenter clinical study in elderly Chinese subjects to     compare the safety and efficacy of the SS Bipolar Head and SL-TWIN Stem with Bipolar Head and     SL-PLUS Stem in hemiarthroplasty of the hip   "
71690|NCT02347384|"     This is a prospective, randomized, multicenter clinical study in Chinese subjects to compare     the safety and efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem with BIOLOX forte     ball head and SL-PLUS Stem in total hip arthroplasty   "
71691|NCT02347371|"     The purpose of this registry is to determine the long term outcomes of heart transplantations     performed at the Semmelweis University Heart and Vascular Center. All eventual interventional     and non-interventional procedures will be accounted for and summarized.   "
71692|NCT02347358|"     This study is to test a hypothesis that temporary implantation of JRecanTM blood flow     recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a     major intracranial artery occlusion following IV r-tPA can provide a greater rate of early     successful recanalisation than treatment of IV r-tPA alone.   "
71693|NCT02347345|"     The investigator's hypothesis is that active injectors will show a partial reduction in     markers of immune activation with HCV therapy whereas non-injectors will show a more     significant reduction in these markers, and will exhibit levels of immune activation that     approach that seen in similarly studied healthy volunteers.This is based on observations that     this group of investigators have made. They have shown that individuals who inject drugs have     high level of immune activation in blood and tissue. Immune activation or chronic     inflammation has been associated with accelerated aging, cardiovascular, renal and liver     disease as well as CNS dysfunction. It remains unclear whether increased levels of immune     activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C,     chronic opiate use, or perhaps combinations of all 3. To understand the potential     contribution of infection with Hepatitis C the investigators will compare levels of immune     activation pre- and post treatment with an all oral, one pill once daily, interferon sparing     treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting     with drugs and the other free of injection for at least 4 months. Immune activation     comparisons will also include non-injecting healthy volunteers.   "
71787|NCT02346123|"     The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1     (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine     signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of     clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.   "
71694|NCT02347332|"     For patients relapsing after platinum-based therapy, few data are available. The current use     of cetuximab associated with radiotherapy in localized disease and associated with     platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic     options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine     demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent     preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based     on a clinical review, show encouraging antitumour activity and an acceptable safety profile.     Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen     after platinum failure.      The present study has been designed as a multicenter, randomised phase III study which will     compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN     patients having failed platinum-based therapy.   "
71695|NCT02347319|"     Purpose      - To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients     with elevated transaminase chronic liver disease.   "
71696|NCT02347306|"     Cardiovascular disease remains the leading cause of death worldwide. Identifying individual     patients at risk of a suture adverse events, including myocardial infractions (heart     attacks), remains a major diagnostic challenge. Recent studies have shown that coronary     plaques responsible for hear attack are composed of a large lipid core with a thin overlying     fibrous cap. Although these features can be identified using invasive imaging modalities,     non-invasive imaging options remain limited due to their poor spatial resolution. Recently     the investigators have developed and validated a novel tool that will allow us to     characterise coronary plaque composition based on dual source CT images. Our aim is to assess     this tool within a cohort of patients who have already undergone a coronary CT as part of a     previous study.   "
71697|NCT02347293|"     The experimental model is a semi-acute, over-night, study where the purpose is to evaluate     food factors related to colonially derived regulation and satiety in healthy subjects.   "
71721|NCT02346981|"     The purpose of the present study was to analyze the effect of 12 weeks of resistance training     on post-exercise blood pressure (BP) and to to correlate the acute and chronic decrease in     blood pressure (BP) following resistance training in normotensive older women. Twenty-eight     older women were randomly assigned to a training group (TG) or to a control group (CG). The     TG underwent a resistance training program (8 exercises, 2 sets, 10-15 repetitions), while     the CG performed stretching exercises (2 sets, 20 s each, 2 nonconsecutive days/week). Both     groups performed the intervention for 12 weeks. At baseline and after intervention the     subjects were submitted to two sessions: resistance exercise session and control session. In     these sessions, BP was obtained in pre and post-sessions. Rest blood pressure were also     measure at baseline and after 12 weeks of intervention.   "
71724|NCT02346942|"     The Primary objective of this study is to understand the rheumatoid arthritis (RA) population     in national integrated delivery network who are treated with first- or second-line biologic     disease modifying anti-rheumatic drug (bDMARD) therapy (with or without Methotrexate) and to     evaluate switching patterns and reasons for switching to another bDMARD.   "
71698|NCT02347280|"     LAY SUMMARY      Clostridium Difficile (C.difficile) is a bacterial infection that can cause an inflammation     of the colon, (C.difficile colitis). This sometimes progresses to a sudden and severe     illness. The present treatment for fulminant colitis is a total abdominal colectomy with end     ileostomy. This means, a surgery is performed which removes the entire diseased colon. The     end of the small intestine is then brought out to the front of the abdomen as a stoma, and     the patient wears a bag. Despite this invasive treatment, there remains a significant rate of     death (38-50%). In addition, patients have a long recovery after this long operation and many     (67%) will not be fit for a second big operation to remove the stoma (that is to reconnect     the intestine).      The purpose of our study is to determine if a loop ileostomy with colonic lavage will result     in better outcomes. A loop ileostomy is when a loop of small intestine is brought out to the     abdomen and the colon remains in the abdomen. The diseased colon, which is preserved, is     washed with a warm solution (like the solution used in a colonoscopy preparation) and then     treated with an antibiotic via this ileostomy. So far, one study has been done using a loop     ileostomy with colonic lavage. 42 patients who underwent this treatment were compared to 42     patients that underwent the standard of care (complete removal of the colon with end     ileostomy). The 42 patients who underwent a loop ileostomy showed a significant decrease in     rate of death compared to the standard of care. Also, in the study, patients who underwent a     loop ileostomy had a much higher rate of reconnection of the intestine (closing the stoma).     The purpose of this study is to see if a loop ileostomy with colonic lavage can treat     patients with fulminant colitis with less risk of death than the standard of care.      Once the patient is diagnosed with fulminant colitis and meets the eligibility criteria,     he/she will be asked by the surgeon on-call if they would like to participate in this     research study. If they agree to be in this study, they must first sign a consent form. They     may be asked by the surgeon to enroll in either the investigational arm (loop ileostomy) or     the standard of care arm. After surgery, all patients will receive the same standard routine     care. During the hospital stay, information will be taken from their chart for purposes of     the study. Routine follow up visits with their surgeon will be at 2, 3, 6, and 12 months     after surgery. If the patient decides to be in the study, the patient will be expected to     complete all the follow up study visits. The patient will not be required to do anything     extra or have any extra tests if they decide to be in the study at any of these visits.   "
71699|NCT02347267|"     The impact of reduction in consumption of caloric and no caloric sweetened beverages on:        -  weight        -  body composition        -  blood pressure        -  young adults   "
71700|NCT02347254|"     The proposed study is to evaluate the safety and initial effectiveness of the ExAblate     Transcranial MRgFUS) treatment of patients with L-dopa induced dyskinesia of Parkinson's     disease (LID PD).      Safety:      To evaluate the incidence and severity of adverse events associated with ExAblate     Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease.      Effectiveness:      To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of LID     in PD patients. Efficacy will be determined utilizing clinical rating scales for dyskinesia     (UPDRS-IV and the Unified Dyskinesia Rating Scale) from examinations at Baseline, 3-Months     and 12-Months post-ExAblate treatment.   "
71701|NCT02347241|"     The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation     Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn     survival and neurologic outcomes.   "
71702|NCT02347228|"     The objectives of this Phase I study are to determine the maximum tolerable dose (MTD) and to     evaluate pharmacokinetics (PK), safety/ tolerability and - preliminary efficacy of OB318 in     patients with advanced solid malignancies.   "
71703|NCT02347215|"     Serial assessment of angina status and ischemia on stress echo over one year among patients     with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.   "
71704|NCT02347202|"     A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling     and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). The     NYU Caregiver Intervention (NYUCI) is an evidence-based intervention that provides counseling     and support for families involved in the care of a relative or friend with Alzheimer's     Disease and Related Dementias (ADRD). Most notably, the NYUCI substantially reduced     caregiver's depressive symptoms, improved their physical health, and extended the time     persons with ADRD remained at home by an average of 1.5 years (Mittelman et al., AG14634,     formerly MH42216; See http://www.ncbi.nlm.nih.gov/pubmed/17101889).      The intervention is now being widely implemented in-person, but there are barriers that     prevent many caregivers from receiving its benefits, including geographic distance;     impediments to older adults leaving their homes; and travel considerations for counselors     which make it impossible to provide the NYUCI in person.      The goal of this study is to evaluate the efficacy of an online videoconferencing version of     the NYUCI. This innovative application has massive implications for social service delivery     to older adults, because it will make it possible to deliver an in-person intervention, via     the internet, which is already evidenced based to older adult caregivers who cannot currently     be served. It will create the online reservation and management technology linking counselors     with families as well as the evidence of effectiveness of providing such services via secure     video teleconferencing vehicles. The proposed Telehealth Technology for Distance Counseling     (TTDC) and related online educational training modules will connect skilled providers to the     families of persons with dementia without regard to geographic location. Implications for     rural healthcare delivery are particularly persuasive. To the investigators knowledge, this     will be the first large-scale TTDC to be developed and rigorously tested with a randomized     controlled trial. The investigators hypothesize that such a system, coupled with online     training for providers and families on tele- counseling and distance caregiving, will have     similar benefits to those achieved with in-person counseling during the original NYUCI RCT.      This project includes an online reservation and management technology linking counselors with     families via secure videoconferencing vehicles. The Telehealth Technology for Distance     Counseling (TTDC), and online technology developed as part of this overall effort, will     connect skilled providers to the families of persons with dementia without regard to     geographic location. The related online clinical modules (i.e., interactive, computer-based     educational materials) developed as a part of this grant effort will prepare counselors to     provide the intervention, and caregivers to utilize the internet software, to be able to     participate in counseling.      The TTDC will include a scheduling system to link counselors to families at their mutual     convenience and assure delivery in a cost-effective manner. The TTDC has the additional     potential to transform ADRD care in ethnic and culturally diverse communities by connecting     highly trained NYUCI counselors with specialized language and cultural skills to families who     would not have access to these resources locally.      In this study investigators will have 240 caregivers navigate the online educational module     and the online reservation system for connecting caregivers with social workers. Half of the     caregivers will then be paired with social service providers to receive counseling over the     telephone, and the other half with be paired with social service providers to receive     counseling via Zoom, a video conferencing program. Recruiting across the United States and     Toronto, Canada.   "
71705|NCT02347189|"     Non-randomized, multi-center, prospective surveillance study to investigate and assess the     residual risks, and to confirm the currently established safety and performance of the Melody     TPV PB1016.   "
71706|NCT02347176|"     The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with     atopic dermatitis   "
71707|NCT02347163|"     Recent evidences suggest that zoledronate (zol), one of the most used bisphosphonates (BPs)     in the clinical setting for the prevention and treatment of bone metastasis in cancer     patients, may have antitumor activity in early breast cancer in terms of improved disease     free survival, overall survival and better response in BPs treated patients. BPs are     mevalonate pathway inhibitors and one of the most intriguing hypothesis supporting their     anticancer activity relies on the modulation of the mevalonate downstream metabolism.     Biologically active mevalonate metabolites are involved in tumour cell proliferation and     invasion and selected cancer subtypes may present a more pronounced mevalonate activity, able     of maintaining an aggressive phenotype. The mevalonate pathway has deep impact on the     function of YAP/TAZ, transcriptional regulators of tumour growth, and preclinical evidences     suggest that BPs are able to interfere with YAP/TAZ expression, via mevalonate pathway. This     study addresses the clinical role of BPs in triple negative breast cancer (TNBC) patients     selected by the level of mevalonate pathway regulation, namely the p53 expression. This study     is a multicenter single-arm, phase II study primarily aimed at assessing the anti-tumor     activity of pre-operative zol measured through its effect on the Ki67 proliferative     biomarker, in TNBC patients classified according to the p53 expression (high vs low p53     expression). Patients with newly diagnosed, untreated, operable TNBC, intended to definitive     breast surgery and suitable for pre-operative therapy with zoledronate will receive a     pre-operative, single administration of zol (4mg i.v.), 7 days before definitive breast     surgery. Ki67 levels will be assessed in tumor samples collected at the time of diagnosis and     after zoledronate treatment at the time of definitive surgery. The secondary objective of the     study is to investigate the effect of zoledronate on critical genes/proteins related to p53     and mevalonate pathways, p53/PIN1 and YAP/TAZ, analyzed in the tumor tissue collected at the     time of diagnosis and at definitive surgery. Zol safety profile will be evaluated by the     NCI-CTCAE scale, version 4.0, and by the occurrence of serious adverse reactions. The total     number of patients required is forty. The overall duration of the project is 32 months (30     months for accrual, followed by 2 months of follow-up after the recruitment of the last     patient).   "
71708|NCT02347150|"     Several patients die in the intensive care unit (ICU) due to their acute disease and comorbid     conditions. Moreover, after ICU discharge, some ICU survivors still die in the wards.      Previous studies have shown that the clinical condition of the patient at the time of ICU     discharge may influence in-hospital prognosis. Non-modifiable factors, such as age and     comorbid conditions certainly play a role. But inflammatory status (especially C-reactive     protein - CRP), Sequential organ failure score (SOFA) score and Therapeutic intervention     scoring system (TISS) 28 score have also been related with the risk of hospital death.      Admission to a high dependency unit may reduce the ICU length of stay (LOS). This strategy     may also help to improve prognosis contributing to further stabilize the patient, facilitate     his autonomy and the removal of invasive devices. However the benefit of a step-down strategy     (from ICU to a high dependency unit) has never been evaluated.      The development of a score to evaluate the risk of patients discharged from the ICU may help     to improve the allocation of resources, either to prolong the ICU stay, or admission to a     high dependency units or the ward.   "
71722|NCT02346968|"     Established markers of kidney function, such as creatinine, have considerable limitations in     the diagnosis of delayed graft function (DGF) after kidney transplantation (KT). Indeed,     creatinine does not accurately reflect minor changes of renal function as its levels change     only upon significant fluctuations of the latter. CAF22 is a molecule which arises from the     degradation of a larger protein and it is proposed to be a reliable and more sensitive marker     of renal function. This study aims to further clarify this issue by measuring blood and urine     concentrations of CAF22 and comparing them with creatinine levels before and after KT.      The main assumption is that blood CAF22 levels could serve as a more sensitive kidney     function biomarker than creatinine post-KT to detect DGF.   "
71709|NCT02347137|"     As the loss of muscle mass with aging is associated with a dysregulation of muscle protein     synthesis (MPS) that is generally characterized by an 'anabolic resistance' to nutrients, the     primary outcome of the trial is to investigate the effect of a mixed macronutrient beverage     on post-prandial myofibrillar MPS. However, the 'anabolic resistance' of aging may be     predominantly influenced by the contractile activity of skeletal muscle; for example, the     investigators have demonstrated that 2 weeks of reduced habitual activity (i.e. daily step     count) induces anabolic resistance in otherwise healthy older adults. In contrast, resistance     exercise is well-known to enhance muscle mass and can increase the sensitivity of skeletal     muscle to dietary amino acids. Therefore, all participants will undergo a 2-week reduced step     count intervention combined with a unilateral leg resistance exercise protocol to induce an     'unhealthy' or 'anabolically resistant' leg and a relatively 'healthy' or 'anabolically     sensitive' leg, respectively; this within subject model will be utilized to investigate the     effect of the mixed macronutrient beverage in both relatively 'healthy' and 'unhealthy' older     muscle. The investigators will also measure changes in muscle mass, muscle function, and     cardiovascular health of both legs before and after the 2-week intervention to determine the     effect of reduced activity and the protective effect of minimal, low-intensity exercise on     these outcomes.   "
71710|NCT02347124|"     The current study will test the effectiveness of a multi-modal behavioral intervention (the     Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking     services through tobacco quitlines.      The investigators hypothesize that, compared to people in the control arm, participants in     the enhanced intervention will:        1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at          6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome].        2. Be more likely to see a dental care professional in the past 6 months at 6 month          follow-up [primary outcome] or at least be more likely to have scheduled a future          appointment [secondary outcome].        3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes          (e.g., self-efficacy, motivation) that could influence future behavior change.   "
71711|NCT02347111|"     In this pilot and feasibility study, the investigators will enroll patients with frequent     symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different     classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide     preliminary data for a larger study in which the investigators will test the hypothesis that     a common AF genetic risk allele modulates response to different AADs.   "
71712|NCT02347098|"     The purpose of this randomized, multi-site, clinical trial is to determine whether intensive     therapy consisting of cholesterol-lowering statin drugs plus apheresis to cleanse the blood     of low-density lipoprotein (LDL) cholesterol is more effective than statin therapy alone in     reducing plaque volume in heart arteries of patients who have already suffered an acute     coronary syndrome (ACS). The study will also investigate whether this intensive approach can     help increase the presence of endothelial progenitor cells (EPC), stem cells that have been     shown to reduce CV events in ACS patients. This study has two phases and FDA approval for     phase II has been received and all information has been updated to reflect PREMIER Phase II.   "
71715|NCT02347059|"     Deep Brain Stimulation (DBS) of the Subthalamic nucleus (STN) is an established treatment for     patients with advanced Parkinson's disease (PD). STN DBS improves dopaminergic     drug-responsive motor symptoms, thus allowing a reduction of post-operative drug dose.     However, a considerable variation in the extent of dopaminergic drug reduction has been     reported, with values ranging from 20% to 100%. Both L-dopa and DAs can be used, however,     there are no formal studies examining which type of antiparkinsonian medication may be more     effective and/or better tolerated following STN DBS.      Aim of our study is to compare the efficacy and the tolerability of L-dopa monotherapy versus     DAs monotherapy after STN DBS over a 3-month follow up period.      This study is a prospective, single blind parallel trial comparing L-dopa monotherapy and DAs     monotherapy after STN DBS. Patients will be enrolled in pairs, with one patient randomly     assigned to L-dopa monotherapy and the other to DA monotherapy after STN DBS (20 patients for     each study arm). Treatment assignment will be unmasked for the patient but will be blinded     for the neurologist programming DBS and evaluating the patient. Another neurologist will be     in charge of medication adjustments. Primary outcome is the change in severity of non-motor     symptoms as assessed by the Non-motor Symptoms Scale (NMSS) at 3-month follow up visit after     surgery.      In spite of an improvement of the motor condition many patients develop apathy and depression     following surgery (Neurosurgery in Parkinson's disease: the doctor is happy, the patient     less so). This study will shed light on the best way to manage patients after STN procedure,     thus contributing to a further improvement of the surgical outcome in a population of young     and motivated patients (those commonly receiving STN DBS), eventually bringing them closer to     a normal personal and social life.      Results of our study may provide new insights in the management of advanced PD after STN DBS,     further leading to development of future larger trials.   "
71716|NCT02347046|"     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety     after single oral administration of FYU-981 to subjects with renal insufficiency and with     normal renal function.   "
71717|NCT02347033|"     Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs people's     functioning. It is often chronic and may be accompanied by depression and other anxiety     disorders. It is not currently clear whether medication or psychological therapy provides     better long term outcomes for those not responding to simpler low intensity treatments so we     propose to compare the clinical effectiveness of a pharmacological treatment (the drug     Sertraline) with a Cognitive Behavioural Therapy (CBT) intervention.      Our hypothesis is that in people with GAD who have not responded to low intensity     psychological interventions, CBT will lead to a greater improvement in their GAD symptoms as     measured using the GAD-7 scale at 12 month follow-up than Sertraline.   "
71718|NCT02347020|"     This study will test the hypothesis that a late sleep (Ls) and/or late meal (Lm) behavioral     pattern, with equal sleep duration, will promote positive energy balance and insulin     resistance (IR).   "
71719|NCT02347007|"     The purpose of this study is to determine whether introducing almonds into the diet of     overweight and obese Blacks and Hispanics improves body composition, decreases liver fat, and     lowers cardiovascular disease profile.   "
71720|NCT02346994|"     The purpose of this study is to compare the effects of a cooking oil on metabolic rate,     appetite, and metabolic risk markers.   "
71727|NCT02346903|"     The purpose of this study is to determine whether there is a positive correlation between the     ability to sense chest pain in the context of myocardial ischemia and the ability to sense     discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active     ingredient on hot chili peppers). Patients undergoing clinical elective balloon angioplasty     of a coronary stenosis will be asked to quantify the subjective intensity of any chest pain     they feel during a standardized episode of myocardial ischemia produced by a one-minute     coronary balloon occlusion, using a previously-validated numeric rating scale. The same     patients will subsequently be asked to grade the subjective intensity of cutaneous discomfort     resulting from application of a capsaicin-containing patch (Capzasin-HP Cream, an     over-the-counter product approved for topical application to treat muscle and joint aches) to     the forearm. The goal will be to determine whether an association can be demonstrated between     the subjective perception of ischemic chest pain during coronary balloon occlusion and     cutaneous capsaicin sensitivity. Such an association could have considerable clinical value,     as it might allow physicians to prospectively assess an individual's ability to perceive     myocardial ischemia/infarction by assessing his/her subjective response to the topical     application of capsaicin.   "
71728|NCT02346890|"     The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics     of AZD1722 in healthy volunteers taking Renvela.   "
71729|NCT02346877|"     This study will evaluate whether the effect of personalized patient counselling tool,     Information-Motivation-Strategy (IMS) based on the results of the Beliefs about Medicines     Questionnaire (BMQ) will improve persistence of Enbrel (etanercept) therapy at week 52 in     subjects with rheumatoid arthritis over the historical control as estimated by the standard     of care.   "
71730|NCT02346864|"     The purpose of this study is evaluating the effectiveness of three-stair-position (TSP) on     the rate of Apnea of Prematurity (AOP), the feeding performance and the vital signs.   "
71731|NCT02346851|"     Post stroke hemiplegia patient have shoulder subluxation in affected side. The investigators     use functional electrical stimulation in posterior deltoid and supraspinatus for prevention     and treatment. But the investigators hypothesis self triggered myoelectric stimulation system     has more effective for shoulder subluxation. The purpose of this study is to compare     post-stroke shoulder subluxation treatment FES and triggered FES.   "
71732|NCT02346838|"     Forty-eight prediabetic men and women (50-75 years of age) will participate in a 6-week     feeding study in which they will randomized to receive either 10 g/day of inulin or placebo.     All subjects will be fed an isocaloric diet (50% carbohydrate, 35% fat, 15% protein,)     controlled for micronutrient content for 6 weeks to avoid the potential confound of     individual differences in diet on gut microbiota. Measurements of intestinal permeability,     insulin sensitivity, and skeletal muscle metabolic flexibility will be made prior to and     following the controlled feeding period. Stool samples will be collected to assess gut     microbial communities.   "
71733|NCT02346825|"     The Baby CHAMP Study is a multisite clinical trial funded by the National Institutes of     Health that is examining the the use of constraint-induced movement therapy (CIMT) for     infants and toddlers as a effective treatment, since there have been no randomized control     trials (RCT) for the age range as well as monitor the stress levels as related by self-report     of parents or biological indicators. Infants and toddlers who meet study eligibility     requirements at one of the three clinical sites (Charlottesville, VA, Columbus, OH, and     Roanoke, VA) will be invited to enroll, and their parents will be provided all necessary     paperwork along with informational documentation.   "
71734|NCT02346812|"     Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3     weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of     typical American foods and will be free of Brassica vegetables and free of glucosinolates and     isothiocyanates. The Brassica diet will contain the control diet plus     glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between     study periods. Blood, urine, and fecal samples will be collected at the end of each study     period. Eligible participants will be selected based on genotype for glutathione     S-transferase (GST), which has been shown to influence the potential protective role of     dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half     (n=9) will have the GSTM1-null genotype.   "
71735|NCT02346799|"     The purpose of this study is to determine whether healthy habits can be formed more     effectively when people are rewarded for repeated engagement in a given healthy behavior at a     specific, routinized time each day rather than at any time.   "
71736|NCT02346786|"     sports accidents and incidents are relatively frequent. We hypothesize that the pursuit of     good hydration, including days without training or competition could prevent their occurrence   "
71737|NCT02346773|"     Currently, there is considerable interest in the possibility that dietary supplementation     with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain     development. Epidemiological and clinical studies support the idea that relative     disappearance of omega-3 diet from the diet in developed countries has been linked with     increases in both physical and mental disorders. Omega-3 deficiency may lead to cognitive     impairment, motor dysfunction and visual acuity problems. It is further known that families     with lower socioeconomic status may have poorer diet and, consequently, may not realize their     full potential regarding their cognitive abilities. The aim of this project is to evaluate     effectiveness of a diet intervention rich in omega-3 acid in healthy children 9-to-12 years     old from less well-off families.   "
71738|NCT02346760|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a     single subcutaneous dose of UB-621 in healthy volunteers.   "
71739|NCT02346747|"     This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of     maintenance Vigil Ovarian (gemogenovatucel-T) in women with Stages IIIb, IIIc or IV     high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary     peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil     prepared and stored from ovarian tumor cells obtained at the time of primary surgical     debulking or initial diagnostic/evaluative laparoscopy (tissue for immunotherapy manufacture     must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo     doses will manufactured. Subjects will have achieved a clinically defined complete response     following primary surgery and adjuvant chemotherapy.   "
71740|NCT02346734|"     The primary objective of this study will be to assess the feasibility and patient acceptance     of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients.      Our hypothesis is that home telemanagement will be effective and useful in the rehabilitation     of multiple sclerosis patients. Specifically, the investigators hypothesize that home     telemanagement using a daily exercise diary, monitoring of compliance with a tailored     exercise program and regular assessment of strength and motor functions will: 1. Be feasible     and acceptable in patients with multiple sclerosis 2. Improve patient compliance with home     exercise program 3. Increase patient mobility and motor functions 4. Be a feasible and     effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve quality     of life   "
71741|NCT02346721|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1,     2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study     GS-US-342-1138.   "
71742|NCT02346708|"     This study plans to learn more about the brain function related to thinking problems in     individuals with Parkinson's disease.   "
71743|NCT02346695|"     Impaired myocardial deformation may determine cardiac diastolic dysfunction. The     investigators will investigate the vascular determinants of myocardial deformation and     twisting-untwisting and their interrelation with exercise capacity in patients with untreated     arterial hypertension   "
71744|NCT02346682|"     There is heterogeneity in patients with depression. Many scholars propose that     individualization of antidepressant achieves better outcomes. However, the scientific     theoretical basis of individualized treatment is still quite weak. Different clinical     subtypes of depression and their possible biomarkers are critically needed to provide the     individualization with theoretical base. Diagnostic types of major depression disorder (MDD)     based on the Theory of Traditional Chinese Medicine (TCM) and possible differentiations in     neurobiochemistry, metabonomics and neuroimaging could be one of ways to explore the     biomarkers and support the theory of the individualized treatment.      The hypothesized results will be of help to clarify the biological basis of MDD with LDQS and     with DBHS, to provide the TCM with further scientific evidence, to explore the pathogenesis     of depression, to improve the objective diagnosis of depression, and to promote targeted     interventions by Western medicine, TCM or both.   "
71745|NCT02346669|"     The incidence of obesity has dramatically increased during the last three decades, leading to     a significant increase of obesity-related morbidity, including type 2 diabetes mellitus     (T2DM) that is characterized by resistance of target tissues to insulin action. T2DM obese     patients may be treated by medications or by bariatric surgery. Both alternatives have     limitations due to incomplete resolution of the diseases, high cost or potential procedural     related morbidity. An increasing body of evidence points to a role of the enteric microbiota     in the pathogenesis of obesity-related insulin resistance. In addition to that, the gut     microbiota is directly affected by the diet composition. Studies in T2DM mice carrying human     gut germs, demonstrated special interactions between the gut microbiota and the host,     creating a typical microbiota composition which changes significantly following diet change     from a western diet, rich with sugar, to a vegetarian diet rich with fibers. This rapid     alternations in the microbiota composition has also shown in humans, after changing from     western to high fiber diet. A change in diet life style may lead to an improvement in T2DM     symptoms such as decrease in visceral adipose tissue.   "
71748|NCT02346630|"     Stroke is the leading cause of acquired long-term disability in adults in developed     countries. Despite aggressive rehabilitation, lasting upper extremity impairment remains in     the majority of stroke survivors. It is hypothesized that enhancing neuroplasticity through     the combination of drug therapy and physical therapy could enhance outcomes for stroke     survivors. The combination of levodopa and intensive physical therapy shows promise in     enhancing the functional motor recovery of stroke patients during the sub-acute and chronic     period without reported significant side effects. Robotic-aided training is a promising tool     that has the potential to deliver high-intensity, task-oriented, reproducible therapy that     can decrease the burden on a therapist. Since the evidence behind dopaminergic potentiation     of neuroplasticity and stroke recovery is promising, it is the investigators aim to combine     dopaminergic drug therapy with highly intensive robotic-assisted therapy to provide superior     upper extremity functional recovery over traditional stroke rehabilitation.   "
71749|NCT02346617|"     To evaluate the safety and efficacy for treatment of persistent CMV infection in     hematopoietic cell transplant (HCT) recipients.   "
71750|NCT02346604|"     People with mild chronic obstructive pulmonary disease (COPD) can have significant     physiological abnormalities and breathing inefficiency which become more pronounced during     the stress of exercise, leading to intolerable breathing discomfort (dyspnea). To better     understand the mechanisms of respiratory symptoms and exercise limitation in mild COPD, we     will examine detailed lung function tests and other important measurements during rest and     exercise in people with mild COPD compared with healthy non-smokers. This will be the first     study to uncover the fundamental causes of breathing inefficiency and the related shortness     of breath during physical exertion in patients with mild COPD. We hope to demonstrate that     one simple measurement during exercise [the relation (ratio) between the total amount of air     breathed (ventilation) and the amount of carbon dioxide breathed out] gives meaningful     information about the extent of damage to the small airways and blood vessels in mild COPD     and the overall gas exchanging function of the lungs, without the need for an arterial blood     sample.      This is a case-controlled observational study not involving an intervention. Participants     will complete 2 visits approximately 1 week apart, each conducted at the same time of day.     Visit 1 will consiste of screening for iligibility, symptom and activity assessments,     pulmonary function tests and an incremental cycle cardiopulmonary exercise test (CPET) for     familiarization purposes. Visit 2 will include spirometry followed by an incremental cycle     CPET with detailed measures of ventilatory, gas exchange, sensory-perceptual and arterial     blood gas responses.   "
71751|NCT02346591|"     The investigators developed a responsive mobile-web app, Jauntly, which was designed to     take advantage of the known connections between positive emotions, stress reduction and     stress resilience. The app's goal was to lead users through research-proven positive     emotion-enhancing exercises and relevant educational materials. Intervention activities     covered five well-being-generating content areas: 1) promoting the experience and recognition     of gratitude; 2) encouraging positive social relationships and feelings of social support; 3)     improving stress resilience via mindfulness and other relaxation-focused activities; 4)     focusing and capitalizing on individual strengths (as opposed to limitations and weaknesses);     and 5) general positive mood inducing activities. Program content was adapted from a variety     of stress-relevant research areas including health psychology/psychosomatic medicine,     social/personality psychology, positive psychology, and clinical psychology.   "
71752|NCT02346578|"     The objective of this study is to compare the efficacy and safety of enzalutamide or     alternative AA therapy in CRPC participants who were previously treated with a combined     androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of     enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC     after treatment with Bic-CAB will be investigated.   "
71753|NCT02346565|"     The overall question the investigators would like to help answer is whether SE with or     without MCE data can be widely used as a first line investigation in women with no previous     history of Coronary Artery Disease (CAD) who present with chest pain of recent onset. In     order to answer this question the investigators will look at the following:      i) Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of     CAD?      ii) What is the additive value of myocardial perfusion data to wall motion data for     predicting significant CAD on angiography and future cardiac events in women?      iii) What is the additive value of Carotid ultrasonography in a large population of women     referred for stress testing?   "
71754|NCT02346552|"     The main objectives of this study are to evaluate the ease of use and performance of the     AutoLap system compared to human camera holder during general and bariatric laparoscopic     surgeries.   "
71755|NCT02346539|"     The investigators will determine whether an acute dose of nicotine, in the form of the     nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in     individuals with major depressive disorder.   "
71756|NCT02346526|"     The purpose of this study is to look for markers of how Ra-223 improves the lives of men with     prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but adds     non-standard testing in an attempt to gain insight about how the drug works and how best to     track patients who are receiving the drug.   "
71757|NCT02346513|"     Primary objectives:        1. To measure serum metal ion levels (blood Chromium (Cr) and Cobalt (Co) ion          concentration) in patients that received the Ceramic on Metal arthroplasty of hip and          who have well functioning primary total hip arthroplasties during short and medium- term          follow up time points.        2. To compare blood ion levels of patient that received COM arthroplasty with the blood ion          levels of patient receiving non-COM standard total hip arthroplasty (a Metal on          polyethylene or ceramic on polyethylene total hip arthroplasty) at short- term and          medium-term follow up time points .      Secondary Objective:      1) To determine whether these blood levels correlate with any device specific factors such     as: component position, size and type, wear rate and/or patient specific factors such as     gender, body mass index, age and activity level.   "
71814|NCT02345759|"     Dietary management of CKD patients proved important to postpone dialysis. Long-term     compliance to protein-restricted diets was discussed. Psychological aspects involved in     certain dietary behaviour have never been studied.   "
71758|NCT02346500|"     Benign prostatic hyperplasia (BPH) is a major cause of lower urinary tract symptoms (LUTS)     affecting aging men. Medical therapy for BPH includes alpha adrenergic blockers and     5α-reductase inhibitors. In men with moderate-severe LUTS due to BPH, surgical therapy should     be considered for 1) those who failed medical therapy and/or 2) those with refractory urinary     retention, renal insufficiency secondary to BPH, recurrent urinary tract infections (UTI's),     or bladder stones. The gold standard for the surgical therapy of BPH has been transurethral     resection of the prostate (TURP). However, TURP is associated with significant comorbidities     such as bleeding, prolonged catheterization, and absorptional hyponatremia. To minimize these     problems associate with TURP, alternative minimally invasive treatment techniques have been     developed. Two of the most commonly used treatment modalities include a photoselective laser     vaporization of the prostate (GreenLight PVP) using the potassium titanyl phosphate (KTP)     laser and holmium laser enucleation of prostate (HoLEP). The major problem in all these     minimally invasive treatment modalities is that they are generally associated with a higher     retreatment rate. In addition, there is no intraoperative and objective measurement, other     than a limited, transurethral visualization of the prostatic cavity, to assess the extent of     the vaporization or enucleation.      We propose to use the transrectal ultrasound (TRUS) and a novel robot, the TRUS robot, to     hold and manipulate the TRUS probe to monitor the extent of the vaporization or enucleation     of the prostate gland intraoperatively. TRUS has been extensively used for the biopsy needle     guidance during prostate biopsy. However, it has never been used during transurethral     prostate procedure. The TRUS Robot has been used safely in the current clinical trial,     NA_00027540, Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical     Prostatectomy. We would like to study the feasibility and safety of using TRUS and the TRUS     Robot to monitor the minimally invasive treatment of BPH, such as GreenLight PVP.   "
71759|NCT02346487|"     The study will be carried out to provide supportive clinical data on the feasibility,     efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be     based on the existing LPV/r pellets which already represent a clear advantage in comparison     with the liquid formulation.   "
71760|NCT02346474|"     Background:      - It is important for doctors to know how much fat a person has in his or her body. Machines     called DXAs measure how much fat mass and fat-free mass a person has. Researchers in this     study have a new DXA machine, and they want to know if it measures body fat as well as the     old machine. They also want to see how body fat readings from the new DXA compare to readings     from a magnetic resonance imaging (MRI) scan.      Objectives:      - To see if two DXA machines give the same results when measuring body fat. Also, to know     whether the DXA and MRI give the same results in measuring visceral and subcutaneous fat.      Eligibility:      - People 18 years and older who weigh less than 350 pounds.      Design:        -  Participants will be screened with a medical history and physical exam. Women will have          a pregnancy test. Researchers will make sure participants are able to have an MRI if          they volunteered to.        -  Participants will have their body fat measured by each DXA scanner. They will lie          quietly on a padded table while being scanned. The scan uses X-rays to take pictures of          the body. Both scans will be done on the same morning and will take 10-15 minutes on          both machines.        -  Some participants also will have their body fat measured with MRI. They will lie in a          long, tube-shaped scanner. The machine uses strong magnetic fields and radio waves to          take pictures of internal organs. Participants will sign an additional consent form for          this procedure.   "
71761|NCT02346461|"     Background:      - People with GNE myopathy have muscle weakness and can have difficulty walking . The disease     comes from a gene mutation related to the production of a sugar called sialic acid.     Researchers think decreased sialic acid may cause the muscle problems. Researchers are     testing the drug ManNAc which is a building block of sialic acid. It is a powder that is     dissolved in water.      Objective:      - To evaluate the safety of 90 days of ManNAc given by mouth.      Eligibility:      - Adults ages 18 60 diagnosed with GNE myopathy.      Design:        -  Eligible participants will be admitted to the NIH Clinical Center for the first visit          and will stay 10 14 days. Participants will have:        -  Medical history and physical exam        -  Electrocardiogram to measure heart function        -  Blood and urine tests        -  Muscle strength tests        -  Magnetic resonance imaging (MRI) muscle scans. Participants will lie on a table that          slides in and out of a metal tube that takes pictures        -  Questionnaires        -  Muscle biopsies. Samples of muscle will be taken, one each from the arm and leg.        -  The study drug as a liquid twice a day        -  Participants may wear a small activity monitor throughout the study. It can be worn on a          waistband.        -  After discharge from the initial visit, participants will take the study drug at home.          Participants will need to record if they miss any doses.        -  Visit 2 will be at 6 weeks for 1 2 days of medical evaluation. Blood samples will be          drawn.        -  Visit 3 will be at the end of the study. Participants will stay in the NIH Clinical          Center for 5 6 days for medical evaluations, muscle tests, and scans. Another muscle          biopsy will be taken. Blood samples will be drawn.        -  Participants will be contacted by telephone or email about 4 times after leaving the          clinic.   "
71762|NCT02346448|"     One of the major elements of successful endoscopic retrograde cholangiopancreatography (     ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various     factors may adversely affect the cannulation procedure of the CBD leading to complications     (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic     sphincterotomy is frequently required for interventional procedures (eg stone extraction).     During sphincterotomy, incision of the orifice of the papilla will be performed by using a     sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of     acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the     papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can     be performed. As a result, bleeding complications and scarring as late effects might be     prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when     using a balloon catheter.      This study aims to evaluate the incidence of acute pancreatitis and other complications after     ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic     sphincterotomy in a randomized multicenter setting.   "
71763|NCT02346435|"     Retrospective studies indicate that active surveillance for clinically localized, small renal     masses (cT1a, <=4cm) is safe. It is our hypothesis that active surveillance is safe and     efficacious when compared prospectively to patients undergoing immediate intervention for     their small renal mass.   "
71764|NCT02346422|"     The purpose of this trial is to characterize the safety profile and preliminary activity of     high-dose MYDICAR® in persons with advanced heart failure when added to their maximal and     optimized therapy.   "
71766|NCT02346396|"     The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic     pain, to estimate the importance and the duration of this effect, and to improve its     efficiency by the use at home.      It is established that the repetition of the sessions of cortical stimulation over a week     improves their analgesic efficacy. However, this effect does not exceed a few weeks and is     much lower than that of the stimulation implanted surgically. Implanted stimulation operates     periodically, several times a day, and this repetition of doses , akin to the regular     taking of a medicine, may explain its longer efficacy for pain relief which, may extend over     several years (André-Obadia and al 2014).      No study at this date has estimated the long-term effect of non-invasive stimulation when is     also periodically repeated on a daily basis, over several weeks.   "
71767|NCT02346383|"     To determine the best parameters with various leads to cover back and leg pain and provide     best pain relief   "
71768|NCT02346370|"     A Phase 1b study for subjects with Stage IIIB/IV NSCLC to participate in 1 of 2 portions of     this study. The first portion is Dose Escalation in which subjects are tested with PEGPH20 at     various doses (1.6, 3.0, 2.2 and 2.8 mcg/kg) in addition to dosing with the standard dose of     docetaxel of 75 mg/m2 (PDoc) once every 21-day cycle. Based on observations on the safety and     tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0     mcg/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 mcg/kg. Up to 30     additional subjects may be enrolled to test these dose levels. The second portion of Phase 1b     is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose     escalation is administered every 21 days to approximately 50 subjects with high hyaluronan     (HA-high) prospectively measured in their tumor tissue.   "
71769|NCT02346357|"     Hip arthroscopy is commonly associated with moderate-to-severe postoperative pain. The     purpose of this study is to investigate the analgesic efficacy of preoperative obturator     nerve block as measured by postoperative pain scores and postoperative analgesic     requirements. The primary outcome will be the patient's first reported pain scores in the     post anesthesia care unit (PACU).   "
71770|NCT02346344|"     A multi-year clinical study to improve tools for measuring the function of insulin-producing     beta cells in people with type 2 diabetes mellitus.   "
71853|NCT02345252|"     This study will evaluate the safety and efficacy of emtricitabine/rilpivirine/tenofovir     alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) versus continuing     emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) FDC in HIV-1 infected     adults who are virologically suppressed on a stable regimen of FTC/RPV/TDF for ≥ 6     consecutive months prior to screening.   "
71771|NCT02346331|"     Sepsis is a clinical syndrome representing deranged hemodynamics (such as tachycardia)     secondary to severe infection. In high-income countries (HICs), early resuscitation of septic     patients with protocol-driven therapy, including quantitative fluid administration guided by     invasive monitoring, has resulted in improved outcomes for septic patients. Prevalence and     mortality of sepsis are thought to be higher in sub-Saharan Africa (SSA) than in high-income     countries; however, most hospitals in SSA lack the technology and resources necessary to     implement the resuscitation protocols used in HICs and therefore, mortality from sepsis     remains high. The World Health Organization (WHO) has recently disseminated an algorithm for     resuscitation of septic patients in low resource settings. This algorithm is based on expert     consensus only, and its efficacy has never been tested.      This study will be conducted in the Casualty Department of Moi Teaching and Referral Hospital     (MTRH) in Eldoret, Kenya.      The purpose of this study is to describe the epidemiology of patients presenting with severe     sepsis, to examine the microbiology causing severe sepsis, to describe current management and     outcomes for severe sepsis, and to test the effect of implementation of the WHO resuscitation     algorithm at MTRH.      The study design is a prospective before and after clinical trial. In an initial     observational phase, adult patients presenting to the MTRH Casualty Department with sepsis     and severe sepsis (the latter of which will be defined by elevated lactate) will be enrolled     into a prospective observational cohort. Demographic data, medical characteristics, and     microbiological studies will be obtained, then the management and outcomes of these patients     will be observed. In a second phase, patients with sepsis will continue to be enrolled into a     prospective observational cohort, while patients with severe sepsis will be enrolled into an     intervention group. Patients in the intervention group will be managed according to the WHO     resuscitation algorithm. Specifically, the WHO algorithm involves fluid boluses guided by     vital signs and physical exam findings, rapid and early administration of empiric     antibiotics, and frequent patient monitoring. The outcomes of interest are achievement of     lactate clearance, which is a correlate of tissue perfusion, as well as 24-hour, in-hospital,     and 30-day mortality.   "
71772|NCT02346318|"     The randomized controlled multicenter clinical study of compound Kushen Injection to reduce     the radiotherapy related adverse reactions in lung cancer is a phase Ⅳ clinical trials，The     main purpose is to evaluate the effect of compound Kushen Injection in preventing and     reducing the radiotherapy related adverse reactions. The participants of the clinical trials     are patients with lung cancer who need thoracic radiotherapy. In clinical trials, one group     of participants is given compound Kushen Injection with chemoradiotherapy, while another     group is only given chemoradiotherapy. The period of trials is 18 months.   "
71773|NCT02346305|"     The effectiveness of NIV is clearly demonstrated but no recent studies describe the     prescription based on clinical data and the conditions of using NIV at home according the     various respiratory diseases.      The investigators' purpose is that a better knowledge of NIV practices could improve both the     quality to support patients at home and the efficacy of the treatment.      The main objective of this study is to analyze the clinical data justifying the prescription     of NIV advice according respiratory disease. The secondary objectives are to study     comorbidities, treatment failures, survival rate during the study period.   "
71774|NCT02346292|"     The study is an observational multicenter descriptive study. It is planned to enroll     approximately 1250 subjects with severe and very severe COPD hospitalized for the reason of     COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in     approximately 20-25 institutions of treatment and prevention in Russian Federation and will     include about 50 to 60 subject at each clinical site.   "
71775|NCT02346279|"     The aim of this survey is the evaluation of the responsiveness and the estimation of the MCID     of the German and French Multiple Sclerosis Questionnaire for Physiotherapists, a self-rating     Patient Reported Outcome questionnaire. This multicenter project uses a combined anchor and     distribution based approach with multiple anchors to provide a range of MCID estimates or a     single MCID for the reliable and valid Items, Activity and Participation group and the Total     Score of the MSQPT, which should to be used as guidelines in daily practice.   "
71776|NCT02346266|"     A stroke awareness program for school-aged children to learn the signs/symptoms of stroke,     teach their parents and make healthy life-style choices.   "
71777|NCT02346253|"     This phase I/II trial studies the side effects and how well high-dose brachytherapy works in     treating patients with prostate cancer that has not spread to other parts of the body.     Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles,     seeds, wires, or catheters is placed directly into or near a tumor and may be a better     treatment in patients with prostate cancer.   "
71778|NCT02346240|"     The purpose of this study is to investigate the efficacy and safety of two dose levels of     certolizumab pegol compared to active comparator and placebo in adults with moderate to     severe chronic plaque psoriasis.   "
71788|NCT02346110|"     This study focuses on optimizing the postoperative pain treatment after major foot and ankle     surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently     used single shot saphenous block only covers half of the pain intensive period from the     saphenous territory, which results in a sharp, break-through pain requiring opioids. The     hypothesis is that this protracted mixture will keep the patients free of pain without the     use of opioids for the entire pain intensive period and thus increase rehabilitation and     patients' satisfaction.   "
71779|NCT02346227|"     1. Introduction Cervical cancer (CC) is a major public health problem in Low-income          countries (LICs), particularly in the Democratic Republic of the Congo (DRC), where the          estimated number of cases is 3839 per year. (WHO, 2010).           Persistent infection with Human Papillomavirus (HPV) is recognized as the necessary          cause for the development of CC. Thus, CC is a disease that is easily preventable          primarily by vaccination against HPV and secondarily through screening and treatment of          precancerous lesions of the cervix.           In LICs, the high incidence of CC is due to both high rates of infection with HPV, a          failure to initiate and sustain effective screening programs based on cytology and the          non-availability of vaccination against HPV. These situations highlight the need to          implement simple and inexpensive screening and treatment methods suitable for LICs.          These methods include screening by visual inspection of the cervix after application of          acetic acid (VIA) and treatment with a topical antiviral drug (AV2).        2. Aims           This study aims to:             -  Evaluate the clinical efficacy of AV2 as a treatment for HPV-associated lesions of               the uterine cervix;             -  Identify HPV genotypes found in Kinshasa;             -  Determine the cost-effectiveness of an algorithm combining screening by VIA and AV2               and that combining VIA and cryotherapy treatment;        3. Methods After basic training of local health workers on VIA, on collection of cervical          samples for HPV testing (quantitative Polymerase Chain reaction, qPCR) and liquid-based          cytology (LBC) and on application of AV2, a screening and treatment program will be          offered to women aged 25 and older who will give their informed consent.      All women with lesions on VIA will be randomized into one of two groups to receive either     treatment by AV2 or placebo.      All women with lesions on VIA will be monitored and reviewed after two months and after six     months for repeat tests (VIA and LBC for lesions, qPCR for viral load, conversion and     reinfection rates).   "
71780|NCT02346214|"     The purpose of this study is to develop a novel, highly automated method of gestational age     estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical     parameters appropriate for use in low income countries. The specific aims of the proposed     study are: (1) To develop an algorithm to predict gestational age at delivery from 26 to 42     weeks' gestation with ALCV and key biophysical parameters (2)To evaluate the performance of     ALCV and biophysical parameter-based gestational age estimates. Specifically, we hypothesize     that the accuracy of the predictive algorithm will be comparable to commonly used measures of     gestational age dating (±2 days) and have better precision (±14 days) than commonly used     measures of gestational age dating.   "
71854|NCT02345239|"     The purpose of this study is to demonstrate the immediate impact of pantoprazole on 24-H     glycemic control and on post-prandial glucose excursion in patients with type 2 diabetes.If     our data support the previous animal, observational and clinical studies results, PPIs could     become a new anti-diabetic agent with a good and safe profile for type 2 diabetes   "
71781|NCT02346201|"     Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled,     masked, 6 month, 10-center randomized clinical trial sponsored by National Institutes of     Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to     examine the efficacy and safety of methylphenidate as treatment for clinically significant     apathy in AD participants. ADMET 2 will enroll participants from real world settings such as     outpatient, nursing home, and assisted living facilities and will examine the effects of     methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety monitoring.   "
71782|NCT02346188|"     Lead is negatively linked to nutritional status, behavior and cognition in children. Despite     extensive knowledge of its toxicity and efforts to reduce exposure, lead continues to be a     problem in developed and developing countries. When lead exposure is unavoidable due to its     pervasive nature, effective means of protecting or disrupting that exposure need to be     developed. Nutritional interventions are one such option. We conducted a 2x2 factorial,     placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children     in Torreón, Mexico (altitude 1060 m). Nine schools were selected based on proximity to a lead     smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30     mg zinc, both, or placebo. In addition to biochemical indicators, cognitive functions and     behavior were evaluated at baseline, after the 6-month supplementation period, and again     after another 6 months (without supplementation).      At baseline, 602 children ages 6.2-8.5 years were enrolled.   "
71783|NCT02346175|"     The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK),     safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in     Type 2 diabetes mellitus patients.   "
71784|NCT02346162|"     The US obesity epidemic is being transmitted to the next generation. Growing evidence     suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during     pregnancy, are associated with increased risk of pregnancy-related complications such as     gestational diabetes and pre-eclampsia, and an increased risk that her child will become     obese and face obesity-related health issues in later life.      Currently, over one-third of reproductive-aged women in the U.S. are obese [body mass index     (BMI) ≥ 30]. Our research team has shown that we can improve birth weight outcomes in babies     of obese women who start a weight-management intervention program at 14 to 15 weeks of their     pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic     programming begin early in the first trimester, well before the first prenatal visit.     Therefore, waiting to address mothers' weight, physical activity, and diet quality until the     first prenatal visit is not optimal. Given the need to reach overweight and obese women prior     to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on     observational studies, that women should reach a healthy weight before conceiving, this     randomized clinical trial will evaluate a comprehensive preconception weight loss program.   "
71785|NCT02346149|"     Diabetes Mellitus (DM) includes several metabolic diseases all characterized by high sugar     levels in the blood. Although diabetic nephropathy is widespread, its underlying     pathophysiological mechanisms remain poorly understood and, so far, little progress has been     made to prevent the development of diabetic nephropathy and to delay kidney functions     decline.      Increasing amount of data based on animal studies support the pathogenic role of tissue     hypoxia in the development and progression of diabetic nephropathy. Blood Oxygenation-Level     Dependent Magnetic Resonance Imaging (BOLD-MRI) is increasingly used in research to measure     cortical and medullary oxygenation in a non-invasive manner. Interestingly, in two     cross-sectional clinical studies, we have recently found a positive correlation between high     circulating blood glucose levels and cortical R2* levels in type 2 DM patients. This     discovery suggests that an increase in glycemia might acutely decrease renal tissue     oxygenation.      The goal of this study is to investigate the impact of serum glucose on renal tissue     oxygenation in healthy subjects and subjects with glucose intolerance.   "
71815|NCT02345746|"     In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients     with liver-only or liver-predominant metastases who have failed at least one line of systemic     chemotherapy.   "
71837|NCT02345460|"     This phase II trial studies how well combination chemotherapy works in treating patients with     pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan     hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving more than one drug     (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.   "
71791|NCT02346071|"     Background:      An increasing number of adolescents report recurrent functional somatic symptoms. Some     experience persistent symptoms and may receive functional somatic syndromes (FSS) diagnoses     (i.e. symptoms not attributable to any known conventionally defined physical disease),     characterised by severe disability and reduced quality of life.      The aim of this study is to:        1. Develop an Acceptance and Commitment Therapy (ACT)-based group intervention for          adolescents with severe FSS (conceptualized as Bodily Distress Syndrome (BDS), see          detailed description).        2. Examine the efficacy of group based ACT in adolescents (aged 15-19 years) with severe          FSS.      The ACT-based treatment, with 9 sessions of group therapy and one follow up meeting is     compared to standard treatment/enhanced usual care, which is one single advisory     consultation.      The study includes approximately 120 patients.   "
71792|NCT02346058|"     Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or     varicose veins combine superficial vein thrombophlebitis.   "
71793|NCT02346045|"     A. Hypertension is a major cardiovascular risk factor and numerous treatment strategies have     been developed to treat hypertension properly and reduce cardiovascular risk.      B. However, there is a subgroup of hypertension which are resistant to treatment.        1. Resistant hypertension is associated to sympathetic hyperactivity        2. Renal sympathetic nerve is known to be associated with systemic sympathetic activity        3. According to research of recent years, catheter based renal sympathetic denervation is a          safe and effective treatment modality to treat resistant hypertension C. Resistant          hypertension is observed in end stage renal disease (ESRD) frequently.      D. Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal sympathetic     denervation is expected to improve resistant hypertension in ESRD patients      F. The aim the present study is to evaluate the effects and safety of catheter based renal     sympathetic denervation on resistant hypertension in ESRD   "
71794|NCT02346032|"     Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary     tract adenocarcinoma   "
71795|NCT02346019|"     The purpose of our study is to improve the fit and function of prosthetic sockets for above     the knee amputees through the use of an outpatient thigh reduction surgical procedure.   "
71796|NCT02346006|"     An increasingly physical inactive lifestyle in the Western World has led to a higher number     of lifestyle -related diseases. The consequences are now already present in childhood with an     increased prevalence of overweight, obesity, and diabetes. Inactivity is also accompanied by     cardiovascular iseases and is also thought to be associated with an increased incidence of     nearsightedness (myopia).      Myopia is the most frequent eye disease globally, and causes severe personal and societal     expenses and may additionally lead to secondary eye disorders such as retinal detachment,     glaucoma, and cataract.      The retina is the only place in the human body where it is possible to directly inspect the     blood vessels (microvasculature). Photography of the eye background allows a noninvasive     examination of the retinal structure in which it is possible to make measurements on the     retinal blood vessels.      It is well known that early vascular chances can be detected with this method and that there     are correlation between these changes and systemic diseases, such as hypertension, stroke and     other cardiovascular diseases.      This study is a new subproject in The Childhood Health, Activity, and Motor Performance     School (CHAMPS) Study Denmark, also known as the Svendborg Project. The project has a     well-defined cohort with originally 1515 school students who since 2007 have been divided     into two groups: schools with extra exercise during school hours and matched traditional     schools. CHAMPS-DK aims to investigate the effect of increased physical activity on current     and future health of children and adolescents.      Thanks to this unique child cohort it is possible to investigate the correlation between     physical activity, myopia and retinal vascular diameters in a large group of Danish     schoolchildren. We want to study the degree and reversibility of physical activity and its     effect on the development of myopia and retinal blood vessel changes. However, there is still     a lack of knowledge about the correlation between physical activity and retinal vascular     diameters in children. Furthermore, it is still unclear whether physical activity can prevent     the development of myopia; such a realization could have far-reaching consequences in form of     a modified approach to the necessity for exercise and, furthermore, potentially a significant     socio-economic benefit.   "
71797|NCT02345993|"     The purpose of this study is to determine whether extra fine formoterol/beclomethasona are     more effective in the treatment of asthmatic crisis when added to conventional treatment     compared with conventional treatment alone.   "
71798|NCT02345980|"     Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria,     dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the     quality of life in 70-80%.      This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil     Citrate) in relieving these symptoms.   "
71799|NCT02345967|"     The purpose of this study is to verify safety and assess tolerance of a long-term, implanted     glucose monitoring sensor. The study will also provide data to characterize the response     properties and calibration of the implanted sensor and determine if such properties vary with     implant duration.   "
71800|NCT02345954|"     The purpose of this study is to compare the operative, anatomic functional outcome as well as     the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to     laparoscopic hysteropexy (conserving the uterus).      The investigators expect that both laparoscopic procedures are equal in regards to operation     time, complication rate, anatomic and functional outcome as well as subjective outcome.   "
71816|NCT02345733|"     The goal of the study is to evaluate strategies that target the microbiota for the treatment     of Ulcerative Colitis , This study will involve a novel diet that the investigators developed     , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic     pathways and use of pathways that increase risk of inflammation . The investigators have     postulated that manipulation of colonic bacterial metabolism with this diet will induce     remission in UC without involving additional immune suppression.   "
71817|NCT02345720|"     The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)   "
71838|NCT02345447|"     The purpose of this study is to study whether a herbal-based medication is superior to     placebo for prevention of acute otitis media in pre-school children with upper respiratory     tract infection.   "
72133|NCT02341573|"     The purpose of this study is conducting a randomized, single blind, controlled intervention     trial to observe the therapeutic effect of experienced chinese herbal formulas based on     different stages and different symptoms in pediatric asthma.   "
71801|NCT02345941|"     This project will utilize the first web-based program to provide tailored injury prevention     education. The existing Safety in Seconds program was adapted into a smartphone platform.     Parents are recruited from and engage in the program in the clinical setting (PED or PTS).     Parents download the app onto their smartphone which is used to ask the questions, collect a     parent's responses, assess the parents' safety needs and give tailored directions for proper     car sear use. The control group parents will also engage with the smartphone app and receive     immediate feedback. However, they will receive tailored educational messages about smoke     alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have     educational features (e.g., tips for keeping children content in their CSSs, links to helpful     websites). The investigators will use emerging technology such as push notification and email     to remind parents to visit the portal and have their child's car seat reassessed.      The investigators plan to conduct a cost benefit analysis of the program's expected financial     benefit from the perspective of a third party payer of medical claims and an in-depth     examination of program adoption and implementation using qualitative data collected from key     informant interviews, direct observations of the clinic environments, and document review.   "
71802|NCT02345928|"     The purpose of this study is to evaluate the safety and tolerability of single ascending dose     of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose     administered IV in participants with asthma and atopic dermatitis.   "
71803|NCT02345915|"     Taking into account the specificities of adolescent and young adult cancer patients led     agencies (in particular the French National Cancer Institute INCa, through the last Cancer     Plan), to initiate projects targeting this population. Acute leukemia is among the most     common cancers in adolescents and young adults. Recent therapeutic advances now allow hope     for a cure in about 50% of this population. The issue of post-cancer is therefore of     particular importance for young adults with cancer. Our aim is to establish the health     determinants in young adult leukemia survivors and to compare the frequency of these effects     and their explanatory factors to the data collected in children or adolescent leukemia     survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer     center and Nice University Hospital have been identified and would be included in this     study.Collected data will include information on the initial disease and its treatments,     physical sequelae (fertility, thyroid function, heart function, visual function, secondary     tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic     syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration     and relationship with care system.   "
71804|NCT02345902|"     Haloperidol and Non-Pharmacologic Treatment are recognized treatments for delirium. This     study will evaluate which is the best treatment for hypoactive delirium.   "
71805|NCT02345889|"     Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval     colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices     attached to the colonoscope tip may improve the ADR of doctors performing a screening     procedure   "
71806|NCT02345876|"     The hypothesis of central auditory processing disorders has been advanced to explain the     anomalies of the grapheme/phoneme combination in some dyslexia. These phonological disorders     may be linked to abnormalities of the efferent (medial olivocochlear) system modulation and     of cortical asymmetry. Indeed, the efferent system has an asymmetry in relation to     handedness. Thus, in right-handed subject, it is predominant on the right side. In contrast,     in the subject-handed dyslexic, the efferent system tends to be right-lateralized or     non-lateralized. However, after an audio-visual training, normal lateralization can appear.     This maturation of the efferent system lateralization during reading acquisition seems to     have a particular profile in dyslexics with phonological disorder, especially if it is     persistent. This finding allows to consider new prognostic evaluation and speech therapy     rehabilitation in the dyslexic child.   "
71807|NCT02345863|"     A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of     a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib     and GA101 maintenance in CLL patients.   "
71808|NCT02345850|"     The study is designed as a three arm randomized Phase III, multicenter trial comparing two     calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis     to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies     undergoing myeloablative conditioning hematopoietic stem cell transplantation.   "
71809|NCT02345837|"     The aim of this study is to detect whether or not performing an endometrial sampling in the     cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in     the next cycle.   "
71810|NCT02345824|"     This is a single-institution, open-label, early-phase study to assess the ability of     ribociclib (LEE011) to inhibit CDK4/CDK6/Rb/E2F signaling and cell proliferation/viability in     core and infiltrating tumor tissues obtained from patients with recurrent glioblastoma or     anaplastic glioma compared to the baseline/primary pathologic tumor specimen. Abundant     preclinical evidence indicates that Rb-deficient cancer cells are resistant to CDK4/6     inhibition and ongoing trials with CDK4/6 inhibitors exclude patients with Rb-deficient     tumors. The investigators will evaluate 10 patients with Rb-positive glioblastoma or     anaplastic glioma in this study. Given that a minority of glioblastomas ha Rb loss the     investigators anticipate enrolling a maximum of 20 patients, to meet our goal of 10 patients     with Rb-positive tumors.   "
71811|NCT02345798|"     This pilot clinical trial studies a video-assisted intervention in improving recovery of     patients undergoing surgery to remove lung cancer or cancer that has spread to the lung and     their caregivers. The intervention uses educational videos to prepare patients and families     for surgery and teach them how to manage the symptoms after surgery. Teaching patients and     their families what to expect before and after surgery may help improve patient and caregiver     quality of life, help patients recover better from surgery, and support families in their     role as caregivers after surgery.   "
71812|NCT02345785|"     The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal     block using ultrasonography in pediatric patient.   "
71813|NCT02345772|"     Hormonal therapy with fulvestrant 500 mg to be administered before surgery With docetaxel,     Trastuzumab, and pertuzumab to determine pathological complete remission rate at the time of     surgery in ER-positive and HER2-positive patients with breast cancer.   "
71818|NCT02345707|"     This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design     in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt     tablet formulations relative to the current CAB sodium salt formulation being used in the     phase IIb studies under fasting conditions. All treatments will be administered as single 30     mg doses of CAB. Safety evaluations and serial PK samples will be collected during each     treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study     drug. Treatment period doses will be separated by a 14 day washout. Participation in this     study will be approximately 12 weeks.   "
71819|NCT02345694|"     The purpose of this randomised controlled study is to determine the impact of continuous     positive airway pressure (CPAP) versus sub-therapeutic CPAP (placebo) on the control of gait     upon severe sleep apnea patients, based on stride time variability.   "
71820|NCT02345681|"     Patients admitted in the Intensive Care Unit (ICU) frequently display and excessive fluid     balance over a very short period of time. This positive fluid balance is the consequence of     different organ failures (pulmonary, cardio-vascular, kidney…) or aggressive fluid     resuscitation, which is mandatory in the early phase of ICU course. However recent data     strongly suggest that an excessive fluid balance could be detrimental per se (increase of ICU     morbidity or even mortality). There are controversies regarding the potential benefit of     controlling this fluid balance with diuretics which are commonly used worldwide in various     indications (acute and chronic heart failure, chronic kidney failure). In the ICU literature     data are lacking, regarding the possible advantages and drawbacks of diuretics in this     indication. The aim of our study is to test an algorithm with furosemide to reduce fluid     overload in severe ICU-patients.   "
71821|NCT02345668|"     The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol     (Emotion Regulation Protocol) for the treatment of unipolar mood disorders (major depression     and dysthimia) four anxiety disorders (Panic disorder, agoraphobia, generalized anxiety     disorder and social anxiety disorder) and obsessive-compulsive disorder in comparison with     Treatment as Usual in specialized care (Spanish public mental health system).   "
71822|NCT02345655|"     In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment     (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and     methadone. Number of treated patients is around 150,000 with 75% of them treated by     buprenorphine. Among the guidelines for improving OMT, urine testing is mandatory for     initiating methadone, whereas it is recommended for initiating buprenorphine and during     follow-up. Urine drug tests are based on immunoassay techniques and enable a qualitative     analysis of the recent drug consumption, with detection based on designated thresholds, allow     a better appraisal of drug exposure, before initiating and during OMT. While intrinsic     diagnostic value of these tests is already demonstrated, the consequences of carrying out     these tests on OMT have not been clearly established. Some studies suggest that patients     exposed to drug tests may have a better OMT retention and in patients treated by methadone,     performing urine screening tests has been shown to be associated with a mortality risk     reduction in a Scottish retrospective cohort of opioid addicts. Actually, despite the     recommendations to perform these tests, few GP prescribe tests, and few patients are     regularly screened. Availability of commercial kits for urine drug testing in the medical     office should improve their utilisation.      The widespread of urine drug screening tests use in ambulatory care is a reality for some GPs     working in addictology networks. Despite a global benefit reported in the literature with a     better control in prescribing OMT and a better patients' adherence, as far as the     investigators know, no study has yet explored the impact of the use of urine drug screening     test in decision making in general practice with an intervention study.   "
71823|NCT02345642|"     We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable)     in both the supine an standing position. We will start supine and will take 3 baseline     measurements of venous velocity and then apply a device and take 3 measurements of the     increase in peak venous velocity. We will repeat this with the second device. We will then     have the subject stand and repeat the above with each device. We will randomize the order of     the devices in the supine and standing position. This study will involve 10 healthy subjects     of various ages and 10 THR patients.   "
71824|NCT02345629|"     The goal of this clinical research study is to learn if a cordotomy reduces pain in patients     with unmanageable cancer pain. A cordotomy is a procedure, guided by computed tomography (CT)     scans, that is performed on the spinal cord and is designed to reduce pain transmission.   "
71825|NCT02345616|"     The pulmonary hypertension (HTP) due to a left heart disease or a hypoxemiant lung disease is     frequent in cardiac surgery. The HTP represents an independent risk factor of morbidity and     mortality in cardiac surgery, entering to the criteria of Euroscore evaluation (European     System for Cardiac Operative Risk Evaluation).      An acute perioperative hemodynamic decompensation of these patients is frequent.     Perioperative hemodynamic modifications, hypoxemia, hypercapnia, sympathetic stimulation,     increase pulmonary vascular resistances (RVP) and might provoke right ventricular failure.      The anesthetic induction and the beginning of mechanical ventilation are the most sensible     times due to the risk of hemodynamic decompensation. The suppression of the sympathetic tonus     which is consequence of the anesthetic induction, decrease the systemic vascular resistances     and lead to decrease of blood pressure. In return, the anesthetic induction is associated     with an increase of pulmonary vascular resistances, resulting in increase of the postcharge     and the work of the right ventricle (VD). These systemic and pulmonary hemodynamic     modifications can lead to equalization, or even an inversion of the systemic and pulmonary     pressures. As consequence, a hemodynamic collapse or even a heart arrest can arise.      The patients suffering from HTP are hypoxemic. They have very limited oxygen reserves due to     decrease of the functional residual capacity (CRF). The apnea period, which follows the     anesthetic induction, is often associated with a fast desaturation, even if a good     pre-oxygenation was performed before. This desaturation causes an increase of the pulmonary     vascular resistances with the hemodynamic consequences previously mentioned. A risk of     hypoxic heart arrest is also present.      Nitric Oxide (NO) is an endogenous mediator produced from the vascular endothelium. The NO is     a powerful vasodilator and is used in intensive care in inhaled way as selective pulmonary     vasodilator (iNO). NO decreases the RVP, the shunt effect and improves the oxygenation by     optimization of ventilation-perfusion ratio. The short lifetime of iNO (6sec approximately)     allows a fast metabolism without inducing any undesirable effects such as the systemic     hypotension.      No studies, until now, have investigated the use of iNO in pre-oxygenation before anesthetic     induction in cardiac surgery.      We hope to demonstrate that iNO used in oxygenation before anesthetic induction will have a     beneficial effect on the respiratory and cardiovascular parameters.      Our objective is to estimate the feasibility and the tolerance of iNO before anesthetic     induction of the patients with a moderate or severe HTP programmed for cardiac surgery with     extracorporeal circulation. The effect will be estimated in terms of efficiency (hemodynamic     and respiratory optimization).   "
71826|NCT02345603|"     Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due     to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected     to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters     around the circumference of each artery. Another 5 patients that are not subjected to the     freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.   "
71827|NCT02345590|"     Weakening and expansion of the main abdominal artery (abdominal aortic aneurysm, AAA) is a     common problem in older Australians. The majority of AAAs are small (<55 mm) and affect     90,000 individuals in Australia and 4.5 million world-wide. Currently, the only treatment     available for AAA is surgery. However, surgical therapies are not effective for small AAAs,     and these patients undergo a program of repeat imaging and consultation to monitor the size     of the aneurysm and symptoms.      This proposal is aimed at addressing the urgent need to identify a medical treatment able to     limit progression of AAAs.      The study design and rationale are based on strong preclinical evidence supporting the value     of eplerenone (an agent indicated for treatment of heart failure) in limiting AAA     progression. If proved effective, this medication would:        1. Reduce the number of patients requiring costly surgery        2. Reduce the number of surgery related deaths and complications        3. Provide a therapy suitable for the rapidly expanding elderly age group who have AAAs.   "
71828|NCT02345577|"     Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early     post-transplantation period and suffer from increasing abnormalities of neuromuscular     functions.      Stochastic whole body vibration (WBV) therapy is a relatively new form of movement     physiotherapy that is used for strength training. Various clinical studies have shown that in     addition to muscle function, WBV also improved body balance and bone mineral density. To     study the impact of stochastic WBV physiotherapy on musculoskeletal parameters after renal     transplantation, kidney transplant recipients will be enrolled and undergo WBV. The     investigators hypothesize that WBV physiotherapy improves both maximum muscle strength and     muscular performance   "
71829|NCT02345564|"     Osteochondral lesions in knee and ankle are injuries commonly seen in young patients.     MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.      This prospective study follows patients treated with MaioRegen implants from pre-surgery     until 24 months post-surgery.   "
71830|NCT02345551|"     This project will assess the feasibility of a 12-week physical activity program developed     specifically for females exposed to a known occupational carcinogen - shiftwork. Physical     activity has been shown to decrease cancer risk, but the investigators research has found     that female shift workers face unique barriers to participating in physical activity. This     project will use a combination of telephone-based behavioural counseling sessions with a     physical activity coach, and innovative web-based physical activity tracking software using a     Fitbit and website or smartphone app to address commonly reported barriers to physical     activity in female shift workers.   "
71831|NCT02345538|"     The purpose of this study is to establish the range of pelvic floor pressure in groups of     women, including women with and without pelvic pain, and compare the change in perineometer     measurements between rest and maximum pelvic floor contraction in women with and without     pelvic pain. Purpose is also to determine whether resting pelvic floor perineometer     measurements correlate with the severity of pain symptoms in women with chronic pelvic pain.   "
71832|NCT02345525|"     The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced     Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT)     delivered in a outpatient setting on upper limb motor recovery in stroke survivors.   "
71833|NCT02345512|"     People with learning disabilities (LDs) experience high levels of health problems, including     cerebral palsy, other problems associated with posture, movement and function, and injury     (falls are the commonest cause of injury in this population, and poor balance/coordination     are a contributory factor). The aim of this project is to investigate the clinical and cost     effectiveness of lycra splinting garments (LSGs), worn to improve posture, movement and     function, for adults (16 years and over) with LDs who fall. This project aims to investigate     the clinical and cost effectiveness of LSGs to prevent future falls of adults with LDs, to     inform practice and guidelines within local and national NHS adult services.      Falls and fall injury are a serious problem for people with LDs (people with LDs experience     similar rates of falls as the elderly in the general population but at a younger age),     whereby interventions are warranted. Labbased 3D movement analysis will be conducted with     adults with LDs who fall during two visits to perform simple tasks (e.g. walking) (once prior     to being provided with LSG, and once 6 weeks after wearing the LSGs at home).   "
71834|NCT02345499|"     To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in     the elderly patients, both in terms of functional and clinical outcome measures. A more     meaningful comparison of the two modalities is that of a randomized controlled trial.   "
71835|NCT02345486|"     The administration of intravenous crystalloids is ubiquitous in the care of the critically     ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte     compositions including a range of chloride concentrations. Recent studies of associated     higher fluid chloride content with acute kidney injury and mortality but no large, randomized     trials have been conducted. In preparation for a large, cluster-randomized,     multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic     crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot     study will enroll all patients admitted to the medical intensive care unit at a single     tertiary center for a sixth month period. The primary objective will be to test the ability     of an electronic order entry tool to ensure administration of assigned study fluid or record     contraindications to assigned study fluid. The pilot study will also demonstrate the     feasibility of collecting demographic, severity of illness, fluid management, vital sign,     laboratory, acute kidney injury and renal replacement therapy, and outcome data in an     automated, electronic fashion.   "
71836|NCT02345473|"     Very few factors may be identified as prognostic for patients with bladder cancer undergoing     radical cystectomy. Recently, detection of circulating tumor cells has shown to be very     promising in anticipating both the likelyhood of distant metastases and survival in patients     with breast cancer, melanoma, prostate cancer and other malignancies. In the present study we     both tested the detection rate of circulating tumor cells using a PCR based methodology in     the peripheral blood of patients undergoing radical cystectomy, and we further correlated our     results with their clinical outcome.   "
71866|NCT02345083|"     Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous     study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in     Indonesian elderly.      This study was aimed to define the risk factors and clinical outcomes of frailty transitional     status in Indonesian elderly.   "
71839|NCT02345434|"     Fraud and waste is estimated to cost the American health care system nearly $200 billion each     year, and the public Medicare and Medicaid programs about $60 billion each year. This study     will evaluate a new method for fighting fraud: mailing informative letters to outlier     providers to notify them of their aberrant behavior. These letters are targeted at high     prescribers of schedule II controlled substances in Medicare Part D. The investigators will     look at the effects of these letters on the behavior of providers and their patients. These     effects are of substantial policy interest as they suggest how to best design anti-fraud     policies. They are also of academic interest, shedding light on the behavior of physicians     and their patients.   "
71840|NCT02345421|"     The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency     (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered     to be at risk.   "
71841|NCT02345408|"     This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in     patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.   "
71842|NCT02345395|"     The study is designed to evaluate the efficacy and safety of minimally invasive neurosurgical     techniques for patients with incidental cerebral aneurysms of the anterior circulation in the     Hospital das Clínicas of the University of São Paulo Medical School.   "
71843|NCT02345382|"     To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, and     recommended Phase II dose of BAY1143572 in a once-daily or an intermittent dosing schedule in     subjects with advanced acute leukemia   "
71844|NCT02345369|"     The purpose of this study is to look at the effect of locking or not locking a set screw when     placing a rod and screws device in the thigh bone and hip to fix hip fractures. The set screw     is an extra screw in the device that will not allow the screw that goes into the ball of the     ball and socket joint in the hip to slide at all in relation to the rod in the thigh bone,     which it goes through. It is not known whether it is better to lock the set screw (not allow     sliding of the hip screw) or leave it unlocked (allow sliding of the hip screw). Participants     in this study are patients with intertrochanteric hip fractures receiving standard care for     this injury (lining the fracture up in a normal position and inserting a rod in the thigh     bone with a screw that goes through the rod into the ball of the ball and socket of the hip).     Patients who consent to participate will be randomized to one of two arms : 1. Set screw is     unlocked or 2. Set screw is locked. Participants will all get standard postoperative care and     standard postoperative xrays.   "
71845|NCT02345356|"     Caribbean Hispanics are a population with a disproportionately high prevalence of     cardio-metabolic disorders but with a limited expectation of benefits from current     pharmacogenetic algorithms derived mainly in subjects of relatively pure ancestry. The     investigators focus on warfarin responses to develop urgently-needed DNA-driven prescription     guidelines for this population, who have arisen from European, West African and Amerindian     genomic origins to produce a highly heterogeneous population. Our project combines admixture     analysis and DNA-sequencing with development of more accurate rules for better predictability     of warfarin dosing to immediately serve this medically underserved population.   "
71846|NCT02345343|"     The primary objective of the study is to report adverse events of on-treatment AEs by the     treating physicians during a specified 24-month study period in patients with venous     thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV)     in Mexico.   "
71847|NCT02345330|"     This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12     DNA injection (pIL-12) with electroporation (EP) in treatment-refractory metastatic and     unresectable squamous cell carcinoma of the head and neck (HNSCC). Intratumoral pIL-12 EP is     a gene therapy approach to directly induce a pro-inflammatory response within a tumor to     initiate and/or enhance anti-tumor immunity.   "
71848|NCT02345317|"     Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in     industrial countries. Reticular pseudodrusen (RPD) have been recognized as an additional     phenotypic characteristic frequently observed in patients with AMD. Several studies have     proven that the prevalence of RPD is associated with AMD as well as a high risk of disease     progression to geographic atrophy, the late form of dry AMD. The pathogenesis of RPD is yet     still incompletely understood. Retrospective studies have demonstrated that the RPD affected     retinal area increases over time. Potential factors influencing progression of RPD have not     been intensely studied and potentially predictive markers are yet unknown. The primary     objective of this study is to characterize RPD progression in more detail and to identify     predictive markers of RPD progression and development of AMD late stages.   "
71849|NCT02345304|"     To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of     midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)     and digoxin (P-gp probe drug)   "
71850|NCT02345291|"     A multicenter, Phase 2a, randomized, double-blind, placebo (vehicle)-controlled,     parallel-group, dose-finding study designed to evaluate the efficacy, safety and tolerability     of NRD135S.E1 in adult patients with diabetes mellitus type 1 or 2 with neuropathic pain.     Potential study patients will sign informed consent prior to undergoing any study-related     procedure.   "
71851|NCT02345278|"     Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an     immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy     and specific immunotherapy (IT). IT represents the only treatment that might alter the     natural course of the disease. The amount of administered allergen is crucial for both     efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual     IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis     and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.      According to the European Medicines Agency Guideline on the clinical development of products     for specific IT for the treatment of allergic diseases, products should be tested at     different dosages to provide preliminary data on safety and tolerability with regard to the     maximum tolerated dose and suitable dose escalation scheme. This trial is designed to     investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.   "
71852|NCT02345265|"     This phase II trial studies how well olaparib and cediranib maleate work in treating patients     with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent).     Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
71855|NCT02345226|"     This study will evaluate the efficacy and safety of emtricitabine/rilpivirine/tenofovir     alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) versus continuing     efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in HIV-1 infected     adults who have been virologically suppressed (HIV 1 RNA < 50 copies/mL) on a stable regimen     of EFV/FTC/TDF FDC for ≥ 6 consecutive months at screening.   "
71856|NCT02345213|"     The purpose of this study is to confirm the efficacy of Aricept in patients with dementia     with Lewy bodies (DLB).   "
71857|NCT02345200|"     Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by     progressive cerebellar ataxia, immunodeficiency, chromosomal instability, and cancer     susceptibility. In addition to that, a high percentage of patients show dystrophy, growth     retardation and poor weight gain. Nevertheless, there are only a few studies assessing this     problem. Aim of the present proposal is to investigate the exact body composition, manual     muscle strength and hormonal status in patients with A-T compared to healthy controls matched     for gender and age. A pelvic sonography in females was performed in order to evaluate the     sexual maturity of their inner genitalia. Tanner score was determined to define the physical     development. Every subject received a nutritional diary to review its calorie intake and the     quality of diet. The investigators expect that the A-T cohort shows an altered body     composition, impaired muscle strength, changed hormonal status concerning the sexual hormones     and a delayed physical development compared to healthy controls.   "
71858|NCT02345187|"     The study will aim to compare the effects of a beverage powder fortified with multiple     micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric     beverage powder (control product) on cognitive outcomes of attention and working memory.   "
71859|NCT02345174|"     Human epidermal growth factor receptor 3 (HER3) expression is seen across a wide variety of     solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression     and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a     monoclonal antibody (mAb) targeting HER3, is a new agent for subjects whose tumors express     HER3. This study aims to characterise the biodistribution and dose-receptor occupancy     relationship of GSK2849330 in patients with advanced HER3 expressing solid tumours via the     use of PET imaging. This study will be conducted in two parts. Part 1 will be the imaging     phase where each subject will receive two doses of GSK2849330 containing both Zirconium-89     (89Zr) labelled GSK2849330 and unlabeled GSK2849330. The amount of unlabeled GSK2849330     present in each dose will be varied to explore the effect on target mediated uptake of 89Zr     into HER3 expressing tissues and tumors. Subjects will then proceed to the continuation phase     (Part 2) for continued treatment with unlabelled GSK2849330. The study is planned to enroll     approximately 12-15 subjects.   "
71860|NCT02345161|"     This is a phase IIIa, randomised, double-blind, double-dummy, parallel group multicenter     study evaluating once daily FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg) inhalation     powder versus twice daily budesonide/formoterol (400 mcg/12 mcg). The primary purpose of this     study is to demonstrate improvements in lung function and health status for subjects treated     with FF/UMEC/VI compared with budesonide/formoterol for 24 weeks. Once-daily 'closed' triple     therapy of a Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting     Beta-Agonist (ICS/LAMA/LABA) combination FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) in a single     device is being developed with the aim of providing a new treatment option for the management     of advanced (GOLD Group D) COPD which will reduce the exacerbation frequency, allow for a     reduced burden of polypharmacy, convenience, and increase the potential for improvement in     lung function, Health Related Quality of Life (HRQoL) and symptom control over established     dual/monotherapies.      Subjects meeting all inclusion/exclusion criteria and who have successfully completed all     protocol procedures at the Screening Visit will enter the two-week run-in period. Following     the run-in period, eligible subjects will be randomised (1:1) to one of the following     double-blind treatment groups: FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg via the ELLIPTA™ dry powder     inhaler (DPI) once daily in the morning and placebo via reservoir inhaler twice daily OR     Budesonide/formoterol 400 mcg/12 mcg via reservoir inhaler twice daily and placebo via the     ELLIPTA DPI once daily in the morning.      The target enrollment is 1800 randomised subjects at approximately 200 study centers     globally. The total duration of subject participation will be approximately 27 weeks,     consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.     Subjects will run-in on their existing COPD medications for 2 weeks and in addition will be     provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue     medication) throughout the study. Subjects will discontinue all existing COPD medications     during the randomised treatment period but may continue their study supplied rescue     albuterol/salbutamol. A sub-set of approximately 400 subjects will remain on blinded study     treatment for up to a total of 52 weeks to provide additional long term safety data.      ELLIPTA and NUBULES are a trade marks of the GlaxoSmithKline Group of Companies. Other     company or product names mentioned herein may be the property of their respective owners   "
71861|NCT02345148|"     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of     intranasally administered esketamine in elderly participants (greater than equal to [>=] 75     years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).   "
71862|NCT02345135|"     Death in Ataxia telangiectasia (A-T) is usually due to cancer or chronic lung failure around     20 years of age. Despite low lymphocyte counts (CD3, CD4, CD8 and CD19), IgA and IgG subclass     deficiency opportunistic and acute severe respiratory infections are rare. The prevailing     wisdom is that an immunoglobulin replacement therapy is not necessary in most of the     patients. However no placebo controlled trials have been performed so far. The aim of this     trial was to investigate the prevalence of mild and severe respiratory infections and / or     chronic cough in classical A-T patients compared to healthy controls.   "
71863|NCT02345122|"     This four-year research study will evaluate an integrated care model of telephone-based,     computer-aided care management using a new role of Mental Health Technician and specialized     software to support primary care providers in providing mental health care. The study will     compare the effectiveness of this model vs. enhanced usual care in improving initiation of     specific treatment by the primary care provider, reduction in severity of symptoms, and     improvement in quality of life or functioning.   "
71864|NCT02345109|"     The clinical protocol of the clinical testing of this device:        1. Objective of the test: To verify the functions and efficiency of devices.        2. Test methods and procedures: Comparison Test.        3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus,          LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.        4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.        5. Study endpoints: DUT and the comparison device are substantial equivalence.        6. Statistical methodology used: Description of statistical methods.   "
71865|NCT02345096|"     This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on     improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a     randomized, double-blind, placebo-controlled study.   "
71867|NCT02345070|"     Primary Objective:      To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597     administered subcutaneously during 52 weeks on lung function of patients with Idiopathic     Pulmonary Fibrosis (IPF).      Secondary Objectives:      To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease     progression.      To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with     IPF.   "
71868|NCT02345057|"     This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate     efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2     Diabetes Mellitus and Microalbuminuria.      The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).   "
71869|NCT02345044|"     This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate     efficacy and safety of different doses of CS-3150 compared to placebo in Japanese     hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and     diastolic blood pressure.   "
71870|NCT02345031|"     This study aims to demonstrate that the investigational drug AUT00063 is effective and safe     in the treatment of age-related hearing loss.   "
71871|NCT02345018|"     The goal of this registry study is to provide insight in the safety and efficacy of treatment     with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient     antero-lateral branches and insufficiency of the GSV below the knee.   "
71872|NCT02345005|"     This post market registry consists of a retrospective and a prospective part. The first part     is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE     mark was obtained, to get an initial insight on the feasibility and safety of this procedure.     The second part is to prospectively register all data on implanted IBE Gore devices, in order     to gain more robust data on the efficacy of the device in maintaining hypogastric artery     patency.   "
71873|NCT02344992|"     The addition of BioChaperone to already marketed prandial insulin analogue accelerates the     onset and shorten the duration of action of insulin lispro due to facilitation of the     absorption of the insulin after subcutaneous injection.      This trial is intented to compare the post-prandial blood glucose control of BioChaperone     insulin lispro and Humalog® when injected after a standardized meal as well as the     pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1     diabetes mellitus.      This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to     compare the blood glucose control after ingestion of a standardized meal, with BioChaperone     Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.   "
71874|NCT02344979|"     Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for     chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and     cisplatin or carboplatin chemotherapy.   "
71875|NCT02344966|"     The objective of this study is to evaluate the prognostic factors of acute leukemia patients     and to invent the molecular genetic test for sensitive detection of minimal residual disease,     and thereby this study would contribute to plan the risk adapted treatment. Patients will     have samples of blood and/or bone marrow collected during diagnosis process, treatment and/or     thereafter   "
71876|NCT02344953|"     The objective of this study is to evaluate the prognostic factors of acute leukemia patients     received stem cell transplantation and to invent the molecular genetic test for sensitive     detection of minimal residual disease, and thereby this study would contribute to plan the     risk adapted treatment. Patients will have samples of blood and/or bone marrow collected     during treatment or thereafter   "
71877|NCT02344940|"     To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with     operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic     abnormality,estrogen level and perimenopausal symptoms.   "
71878|NCT02344927|"     It is unclear whether the use of fluids given by a drip is beneficial to cancer patients in     the last days of life, and as a result many individuals do not receive such treatment     (although they do receive fluids by mouth, and regular mouth care). The researchers want to     undertake a large study (main study) to determine the benefits of fluids given by a drip,     but first need to undertake a small study (feasibility study) to ensure that the main study     can be done.      The feasibility study will be done in twelve units (hospitals, hospices) in England & Wales;     each unit will be allocated a treatment at random, and all patients in the unit will receive     that treatment (if appropriate). Standard treatment A consists of drinking fluids (if     possible), regular mouth care, and treatment of any symptoms; standard treatment B consists     of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of any     symptoms.      Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be     recorded. The main symptom of interest is agitation (delirium), which has multiple causes,     including dehydration and kidney failure. Uncontrolled symptoms will be appropriately     treated, e.g. patients with pain will be given painkillers. Equally, problems relating to the     fluids given by a drip will also be recorded. Involvement in the study will not interfere     with the patient's general care, and there will be no additional blood or other tests.   "
71879|NCT02344914|"     To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage     of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.   "
71880|NCT02344901|"     The aim of this study is to evaluate the present status of stroke prevention strategies in     patients with non-valvular atrial fibrillation (NVAF). Vitamin K antagonists (VKAs) have been     the only available oral anticoagulant therapy for decades. Recently novel oral anticoagulants     have emerged as an alternative for VKAs. This study is planned to evaluate the     epidemiological characteristics, thromboembolic and bleeding risks, stroke prevention     strategies and appropriateness of oral anticoagulant use in NVAF patients. Time in     therapeutic range (TTR) is going to be calculated as the percent of visits in range (2-3) for     warfarin patients. This is a national multicenter observational study in which Turkey is     divided into seven regions. A proportional number of patients to the population of every     region is planned to be included.   "
71881|NCT02344888|"     The purpose of this study is to evaluate the effect of concomitant administration of     prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile     lean women having CC resistant polycystic ovarian syndrome (PCOS).   "
71883|NCT02344862|"     The purpose of this study is exploratory investigation of safety and efficacy (dose response     and optimal dose according to the percent reduction from baseline in serum urate level at the     final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout     for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks)     by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel     group comparison.   "
71884|NCT02344849|"     This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem     Cells (MSC) injected intracavernously.   "
71885|NCT02344836|"     Smartphones have the capability to monitor health-related behaviors (exercise, diet, etc.)     and provide social support which has the potential to play a powerful role in health     promotion. The objective of this study is to refine and pilot test the Social POD app for     personalized health monitoring and interaction founded on a combination of social networks,     recommender systems, motivational research, and health behavior theory. The aim of our     proposed project is to conduct a 3-month pilot RCT among overweight and obese adults (N=150)     comparing a theory-based podcast (TBP) plus self-monitoring using a commercially-available     calorie and weight tracking app (current most popular diet self-monitoring method) versus TBP     plus self-monitoring and social support/incentive points for participating with the Social     POD app (TBP+Social POD).   "
71886|NCT02344823|"     The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal     hemodynamics in patients with liver cirrhosis.   "
71887|NCT02344810|"     This partially randomized phase I/II trial studies the side effects and best dose of c-Met     inhibitor AMG 337 when given together with oxaliplatin, leucovorin calcium, and fluorouracil     and to see how well they work in treating patients with stomach or esophageal cancer that has     spread to other places in the body and usually cannot be cured or controlled with treatment.     C-Met inhibitor AMG 337 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as, oxaliplatin, leucovorin calcium,     and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving c-Met     inhibitor AMG 337 with oxaliplatin, leucovorin calcium, and fluorouracil may kill more tumor     cells.   "
71888|NCT02344797|"     Worldwide, more than 200 million patients have major non-cardiac surgery annually and a     significant proportion of these patients suffer major cardiovascular complications (e.g.     nonfatal myocardial infarction, cardiac arrest, vascular death) within 30 days of their     surgery. Perioperative myocardial infarction is the most common cardiovascular complication     and recent clinical studies have shown that even minor myocardial injury in relation to     non-cardiac surgery is associated with 30-day mortality.      Remote ischemic preconditioning is a procedure, which protects remote tissues and organs e.g.     against ischemia-reperfusion injury. Cycles of forearm or leg ischemia and reperfusion by the     inflation of a blood-pressure cuff for brief periods are the preferred method.The aim of this     interventional clinical study is to determine whether remote ischemic preconditioning can     reduce markers of myocardial injury in emergent or urgent non-cardiac surgery.   "
71889|NCT02344784|"     The purpose of this study is to show that Prepulse inhibition test of acoustic startle     response is an indicator of objective diagnostic characteristics of attention deficit     disorder in children and adolescents.      by demonstrating that Prepulse inhibition test of acoustic startle response is impaired in     children and adolescents suffering from attention deficit disorder in the relation to the     normal function described in the literature.      The investigators will try to prove our hypothesis by an experiment that consists of two     phases:      Phase I (about 25 minutes):      The patient will enter the room, will be asked to sit on a chair, and will be asked to look     at a computer screen showing silent video of aquarium fish, then the patient will be     connected to both the Prepulse inhibition test device and the Galvanic skin response device     and pass the tests.      Phase II (about 25 minutes):      After completion of Phase I, each participant will receive his daily regular dose of     methylphenidate and after an hour and a half from taking the drug, will repeat the tests,     both the Prepulse inhibition test and the Galvanic skin response test.      Duration of the entire experiment is 140 minutes (two hours and twenty minutes).   "
71890|NCT02344771|"     More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die     within 30 days post-operatively, and of these patients 45% will die from vascular causes such     as myocardial infarction. The pathogenesis of perioperative myocardial infarction is complex     and to date not fully elucidated. The physiological stress response associated with the     surgical procedure is believed to be central in the development of perioperative     cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability and     increases the production of catecholamines and cortisol. These drastic systemic changes lead     to a state of myocardial oxygen supply-demand mismatch, which added to acute endothelial     dysfunction and ruptures of vulnerable plaques, may result in myocardial injury.      The endothelium is a regulator of vascular homeostasis, vascular tone and structure and     exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is     characterized by a decreased vascular bioavailability of nitric oxide probably due to an     increased degradation of nitric oxide via its interaction with locally produced reactive     oxygen species. No clinical studies have investigated whether peri- and postoperative     endothelial dysfunction is associated with an increased risk of perioperative myocardial     injury. Endothelial dysfunction may be a key element in the development of perioperative     myocardial injury.      The aim of this observational clinical study is to closely examine the endothelial function     and its dynamics in the early postoperative period.   "
71891|NCT02344758|"     The purpose of this study is to develope a novel method to determine gluten intake and to     check gluten-free diet adherence in celiac patients by detection of gluten immunogenic     peptides in urine.   "
71927|NCT02344290|"     The study is funded by the National Heart, Lung, and Blood Institute, with additional     infrastructure support provided by the National Institute of Allergy and Infectious Diseases.      People infected with HIV are at risk for cardiovascular disease (CVD). This study will     evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who     are on antiretroviral therapy (ART).   "
72238|NCT02340195|"     The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine     following multiple dosing in patients with renal impairment and compare to those in healthy     subjects   "
71892|NCT02344745|"     Urodynamics are performed in the evaluation of urinary incontinence in women considering     surgery or who have failed conservative therapies. Urodynamic testing requires the placement     of small catheters into the bladder and the vagina or rectum. Many women experience anxiety     around the procedure which can affect patient satisfaction. Lavender aromatherapy has been     associated with decreased anxiety in a variety of clinical situations. The purpose of this     study is to determine a difference in self-reported anxiety and pain levels before, during,     and after multichannel urodynamics in patients given lavender aromatherapy versus placebo.     This study design is a randomized control trial. Women scheduled for urodynamic testing at     the Los Angeles County University of Southern California (LAC+USC) Urogynecology clinic will     be invited to participate. Participants will be randomized to the aromatherapy or the placebo     group after informed consent is obtained and immediately before undergoing multichannel     urodynamics. The participants will complete the Hospital Anxiety and Depression Survey (HADS)     at baseline. They will be asked to rate their level of anxiety and pain before, during, and     15 min after the study using the visual analogue scale and Wong-Baker pain scale. At the end     the participants will also be asked to rate their satisfaction with the visit overall. The     primary endpoint is defined as anxiety immediately after catheters are placed. Data will be     entered into a coded database for analysis using the independent samples t test, the     Mann-Whitney U test, and the chi square test. Intention to treat analysis will be used.   "
71893|NCT02344732|"     1. To compare the corneal epithelial defect healing time between diabetic patients          receiving and not receiving supplementary oxygen after vitrectomy.        2. To determine whether factors such as age, duration of diabetes, duration of surgery and          level of glycemic control have any influence on corneal epithelial wound healing time in          diabetic patients receiving and not receiving supplementary oxygen post-vitrectomy.   "
71894|NCT02344719|"     The investigators want to analyze the effect of Taurin on portal hemodynamics in patients     with advanced liver cirrhosis.   "
71895|NCT02344706|"     A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain     unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to     diagnose, and impossible without the required instruments. Electroencephalogram is required     in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and     implementation of such a device in the prehospital field is little studied. The aim of this     study is to evaluate the diagnostic value of the acquired electroencephalogram with a     prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The     EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three     channels are monitored, as this is deemed sufficient for the prehospital field, as well as     for monitoring the epileptic seizures.   "
71896|NCT02344693|"     Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect     the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following     a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to     survive. Monitors for evaluating the cardiac function during and after resuscitation are     implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac     sonography), but no devices for registration of the cortical brain activity exist. The aim of     this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter,     connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain     spontaneous circulation following non-traumatic cardiac arrest.   "
71897|NCT02344680|"     In this study the investigators will determine risk factors for liver fibrosis among HIV-HBV     co-infected patients in Lusaka, Zambia, and assess the long-term effectiveness of     antiretroviral drugs in the prevention and/or reduction of liver disease.   "
71898|NCT02344667|"     Recent studies support the use of Stereotactic Body Radiation Therapy (SBRT) for the     treatment of localized prostate cancer (PrCa). SBRT is a way to deliver radiation very     precisely allowing higher doses to be delivered with fewer treatments, potentially improving     patient outcomes. Cyberknife and Volume Modulated Arc Therapy (VMAT) are accepted SBRT     techniques. However, the effects of the specific SBRT treatment technique on patient outcomes     have not been evaluated in randomized trials.      Although such a trial would be of great interest, patients' willingness to participate is     unclear. Multiple patient and clinician factors contribute to the decision to enter a     randomized trial. This feasibility study will evaluate patients' willingness to participate     in a trial comparing Cyberknife and VMAT SBRT for the treatment of early stage PrCa. Patients     accepting enrolment will be randomized to one of the two types of SBRT delivery. Up to 66     patients will be approached, and up to 40 randomized. A questionnaire will help to identify     the factors influencing the patient's decision to participate or not. This study will gather     information on feasibility, PSA control, patient outcomes and side effects, and will inform     the design of a future randomized phase II/III study.   "
71899|NCT02344654|"     The primary objective is to compare the success rates of intraoperative fluorescent     cholangiography using indocyanine green versus conventional X-ray cholangiography for the     identification of bile duct anatomy during laparoscopic cholecystectomy for complicated     gallstone disease in a randomized design with 120 patients.   "
71900|NCT02344641|"     The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart     failure patients with exenatide, and also investigates the mechanisms of exenatide improving     heart function.   "
71901|NCT02344628|"     The study will be a single blinded, randomized, controlled open label non-inferiority phase     III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The     ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg     dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws     patients will be included in the study. Patients will be randomized to receive treatment with     the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg     azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The     follow-up period of patients will be 6 months. Assessments before, during and after the     antibiotic treatment will include full medical history, clinical assessment of the lesion     and, laboratory investigations. The primary efficacy parameters are healing of the lesion at     4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.   "
71902|NCT02344615|"     The investigators compared the postoperative analgesia of nerve stimulator-guided and     ultrasound-guided infraclavicular block for upper extremity surgery.   "
71903|NCT02344602|"     Patients with type 1 diabetes mellitus (T1DM) are at high risk of developing kidney     complications potentially leading to end stage renal disease. Uric acid (UA), the end product     of purine metabolism, emerged as an important determinant of renal and vascular injury due to     its ability activate the renin-angiotensin-aldosterone system (RAAS) and increase production     of harmful reactive oxygen species (ROS). ROS cause progressive endothelial cell dysfunction,     inflammation, tissue fibrosis and eventually cell death. These processes are enhanced in DM     because of the effect of hyperglycemia.      Since existing preventive drug therapies fail to completely prevent kidney damage, an     examination of the effect of UA lowering against initiation and progression of renal and     vascular complications is therefore of the utmost importance. The purpose of this study is to     examine the effect of UA lowering with febuxostat on renal and systemic vascular function in     patients with uncomplicated T1DM. It was hypothesized that UA lowering will improve kidney     and systemic vascular function through effects on blood vessel function and anti-inflammatory     effect.      Kidney and blood vessel function will be assessed under conditions of normal and high blood     sugar levels before and after 8 weeks of treatment with the UA lowering drug febuxostat in     patients with diabetes and during normoglycemia only in health controls.      Current treatment for renal and vascular complications in DM patients includes blockade of     the RAAS. Unfortunately, angiotensin converting enzyme inhibitors (ACEi) and angiotensin II     (AngII) receptor blockers (ARBs) lead to incomplete RAAS suppression, and do not completely     prevent renal or vascular complications. Moreover, dual RAAS blockade increases renal and     cardiovascular risk. Recent experimental work suggests that UA lowering therapies can block     the RAAS, suppress inflammation and promote renal and systemic vascular protection.     Therefore, our study is critical in determining the possible role of early UA lowering on     renal and systemic hemodynamic dysfunction in young patients with T1DM.   "
71904|NCT02344589|"     Our aim is to investigate which components of the quadriceps femoris muscle are affected     following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by     electromyography. Both a placebo treatment (20ml saline) and the femoral nerve block (20ml     lignocaine 1%) as an active comparative will be used for model control. Further, we want to     investigate the effect of volume on motor block. This will be evaluated by measuring the     Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle.   "
71905|NCT02344576|"     The left ventricular assist device (LVAD) is growing rapidly among people dying from     end-stage heart failure who are unable to get a heart transplant. These patients elect to     live out the remainder of their lives dependent on a partial artificial heart—so-called     destination therapy (DT). Although patients may live longer with a DT LVAD, it poses many     risks, including stroke, serious infection, and bleeding. Most of these patients have other     medical problems that are not fixed by the DT LVAD. Patients must be connected to electricity     at all times. A caregiver is required, which often places stress on loved ones. Therefore,     the decision whether or not to get a DT LVAD is often an extremely difficult one.     Unfortunately, our research shows problems with the way this medical decision is currently     being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do     not follow a standard process. The forms, pamphlets, websites, and videos used to help     patients and families are biased and too difficult for most people to understand. Lastly,     this is an emotional and even scary decision for most patients and their families, but the     process does not help them deal with these feelings.      Using feedback from patients, caregivers, clinicians, the study team made a paper and video     decision aid to help people who are offered DT LVAD make this most difficult of decisions.     Unlike the information that is now available, our decision aid focuses on options, fears, and     the needs of caregivers, is balanced, and is paired with training for doctors and nurses on     how to best talk about DT LVAD. The investigators now propose to test the effectiveness and     implementation of this intervention. The investigators will apply the Reach, Effectiveness,     Adoption, Implementation, Maintenance (RE-AIM) evaluative framework to a stepped-wedge,     cluster-randomized, controlled trial across 6 medical centers.      Aim 1. Evaluate the Reach and Effectiveness of the DT LVAD shared decision support     intervention to improve patient and caregiver experiences.      Hypothesis 1a: The intervention will reach 90% of eligible patients. Hypothesis 1b:     Post-implementation, patients and caregivers will have improved decision quality (greater     knowledge and higher value-treatment concordance).      Aim 2. Assess the Adoption, Implementation, and Maintenance of the DT LVAD shared decision     support intervention across multiple providers and settings.      Hypothesis 2: The intervention will be: adopted by key personnel; implemented consistently;     and maintained after trial completion.   "
71906|NCT02344563|"     A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two     formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion     in healthy volunteers.   "
71907|NCT02344550|"     The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole     with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen     treatment.   "
71908|NCT02344537|"     The investigators wish to conduct a preliminary study to examine the efficacy of meditation     among patients with Post Treatment Lyme Syndrome (PTLDS). Specifically, the investigators     will use the breathing, meditation, and stretching techniques common to Kundalini Yoga     practice. The investigators plan to assess the degree in which this practice can reduce     Post-Treatment Lyme Disease symptoms. Because fatigue and pain are so common among patients     with PTLDS, the primary focus of this study will be fatigue and pain. Secondary outcomes will     include cognitive complaints, physical and mental functioning, medical utilization, somatic     symptoms, and psychopathology.   "
71909|NCT02344524|"     The purpose of this trial is to study the role of small bore chest drains in draining     traumatic hemothorax and pneumothorax.   "
71910|NCT02344511|"     Dalbavancin for Pediatric Osteomyelitis   "
71911|NCT02344498|"     Viral hepatitis kills nearly one million people each year, even though effective treatment     exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is     simple and cheap enough to be implemented in resource-limited settings.   "
71912|NCT02344485|"     The aim of this pilot study is to investigate the effect of Osteopathic Manipulative Medicine     (OMM) in decreasing constipation symptoms in people with Parkinson's disease (PD). A second     but optional aim is to determine if OMM changes the bacterial flora of the mouth and gut. OMM     is a safe and gentle manual treatment provided by osteopathic physicians. All participants     will receive OMM during the second half of the eleven week trial.   "
71913|NCT02344472|"     A multicenter, randomized phase III study to compare chemo- versus endocrine therapy in     combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta®     (pertuzumab) in patients with HER2 positive and hormone-receptor positive metastatic breast     cancer.   "
71914|NCT02344459|"     The purpose of this study is to perform a randomized controlled trial to compare the efficacy     of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction     cervical ripening by evaluating the change in Bishop score.   "
71915|NCT02344446|"     The purpose of this study is to investigate if skilled physical therapy treatment for     dizziness after sports-related concussion, delivered after greater than 30 days     post-concussion is effective to remediate physical symptoms. This will be the first study     that explores differential PT treatment for dizziness in concussed athletes who have physical     symptoms 30+ days after concussion. The findings of this important research have great     potential to influence clinical practice and place increased emphasis on and acceptance of     manual skills and neuromotor training in the treatment of concussed patients with dizziness.   "
71950|NCT02343978|"     The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic     Constipation (CC) patients.   "
71916|NCT02344433|"     A Relational Agent (RA) virtual counselor (VICKY: VIrtual Counselor for Knowing Your Family     History) has been developed to collect family health history information for common health     conditions including heart disease, stroke, diabetes, hypertension and various cancers. In     this study, the investigators will conduct a randomized controlled trial (RCT) to compare the     efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting     family health history information among an underserved primary care patient population. The     primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting     accurate family health histories and 2) determine whether accuracy varies as a function of     health literacy. This project will obtain validation data on the efficacy of both VICKY and     MFHP for collecting accurate family history data among an underserved patient population, in     two languages (English and Spanish). The study will determine whether a virtual counselor can     overcome many of the existing barriers to using traditional web-based family history tools.   "
71917|NCT02344420|"     BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response     rate in a Heart Failure (HF) population with an equal distribution of men and women.     Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF     etiology…) and compared in order to demonstrate that women may respond even better than men.   "
71918|NCT02344407|"     Background:      - Ebola virus disease (EVD) affects many people in Liberia and other countries in West     Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting,     diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved     treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause     Ebola.      Objectives:      - To study the safety and efficacy of two Ebola vaccines.      Eligibility:      - Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never     had Ebola.      Design:        -  Participants will give information including birthdate, gender, occupation, and location          of home. They will give contact information for themselves and 2 alternate contacts.          They will give a history of their contact with people with Ebola. Some participants may          have a physical. They may have blood taken.        -  Participants will be injected with either an Ebola vaccine or a placebo with a needle in          the upper arm. The placebo is a salt solution.        -  Participants will have blood taken.        -  Participants will be watched for 30 minutes.        -  Participants will return to the clinic 1 week and 1 month after they get the shot. They          will have blood taken.        -  After that, participants will be contacted monthly to discuss how they are feeling. They          may be contacted by phone, may visit the clinic, or may have a home visit.        -  The study ends 8-12 months after participants get the shot. If one of the vaccines works          against Ebola and does not have many side effects, participants can get the vaccine if          they did not get it in the study.   "
71919|NCT02344394|"     The overall objective of the study is to compare and assess the clinical outcomes of the     standard of care hybrid ablation using epicardial ablation in conjunction with endocardial     PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with     additional RF ablation in a randomized, prospective population of patients with persistent AF     of at least 6 months duration. All devices that are used are being utilized under the     approved labeling of the devices.   "
71920|NCT02344381|"     Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and     muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles     and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)     levels. Both liver and muscle glycogen are important for our ability to perform     intense/prolonged endurance exercise. Therefore, it is important to replete these stores     after an intense/prolonged endurance exercise session in order to recover and perform     optimally during a subsequent exercise bout, especially if the next exercise session is     within 24h (e.g. stage races such as the Tour de France, tournament-style competitions such     as the Olympic games and ultra-endurance events).      Carbohydrate intake has been shown to increase the availability of glycogen in the muscle and     liver after exercise. The carbohydrates typically found in sports drinks are glucose and     sometimes fructose. It has been observed that the ingestion of glucose will lead to a maximum     rate of absorption of approximately ~1 g/min. However, if we also provide a different source     of carbohydrate (fructose) then this is absorbed through a different pathway and therefore we     can absorb up to ~1.75 g/min of carbohydrate. In addition, both carbohydrate sources are     metabolised differently in the human body. By supplementing both glucose and fructose, we can     potentially replenish the liver and muscle glycogen stores at a faster rate than ingestion of     glucose only.      Sucrose is a naturally occurring sugar that is made up of a single glucose and single     fructose molecule. Therefore, theoretically, this can use the two different pathways of     absorption and also maximise carbohydrate delivery. It is not yet known however, what impact     this has on our liver and muscle glycogen stores post-exercise when supplemented in     relatively high amounts. Therefore the aim of this study is to assess whether relative high     amounts of sucrose ingestion will improve liver and muscle glycogen repletion after endurance     exercise.   "
71921|NCT02344368|"     Despite the fact that oral sucrose is the most frequently studied non-pharmacological     intervention for procedural pain relief in infants, there is a paucity of data on the minimal     effective dose. The aim of this study is to find the minimal effective dose of sucrose to     reduce pain during a single venous blood sampling procedure.   "
71922|NCT02344355|"     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care     treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will     receive high-dose ascorbate in addition to the standard treatment.   "
71923|NCT02344342|"     The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a     home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure     patients in the University of Michigan Health System (UMHS).   "
71924|NCT02344329|"     A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and     TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care     and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare     healing rates between two treatment modalities in patients with DFUs in an ambulatory wound     care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with     standard treatment.      Adult participants 18 years or older with a diabetic foot ulcer located on the plantar     surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse     Practitioner visit to participate in the study if they have not demonstrated a 50% in     reduction in wound area after two weeks of standard treatment. For those potential subjects     who do not have 3rd party reimbursement the cost of the product and application will be     covered by the respective company. They must be cognitively intact as evaluated by wound     clinic primary care providers. Participants must agree to use the study treatments as     directed, and to keep clinic visits during the 12-week trial or until the ulcer closes,     whichever comes first.   "
71928|NCT02344277|"     Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and     sudden death resulting from episodes of polymorphic ventricular tachychardia and     fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only     treatment available is the implantation of an ICD. There is no discussion on the interest of     the ICD implantation in secondary prevention and in patients who experienced syncope but the     best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated     that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there     was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks     can be solve with a good ICD programming and (iii) the problem of lead failure remains the     main problem in this young population very active and represent the main limitation to larger     indication of ICD implantation in this population with a very long life expectancy as these     patients had a normal life expectancy except the risk of ventricular arrhythmia.      In this context the S-ICD System (Boston Scientific Inc.) which is an implantable     defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse     generator and electrode system rather than a transvenous lead system, represents a very     attractive opportunity as it gives the possibility to protect the patients of the risk of     ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and     as Brugada syndrome patients are a very specific population (very active patients, specific     and changing over time ECG aspect that is at risk of T wave over sensing and high risk of     SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this     specific context.   "
71929|NCT02344264|"     The patients will be included the 1. or 2. day after surgery. All THA patients will be     screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to     participate.      Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then     ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be     45 minutes between the two blockades. The blockades will be ultrasound guided.   "
71931|NCT02344238|"     In pharmacotherapy trials in drug-dependent populations, medication compliance is a     significant issue, as rates tend to be low and adherence to medication may predict improved     outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).     However, methods commonly used to determine compliance may result in inaccurate measurement     of adherence. It is therefore essential to develop measurement systems that not only     accurately and objectively measure compliance, but can also have the potential to increase     compliance in difficult to treat disorders such as addiction. In this study, we propose to     assess the acceptability, tolerability, and efficacy of the ID-Cap, a novel compliance     measurement device, in a healthy population.   "
71932|NCT02344225|"     Phase 2, open-label, randomized, multi-center studies in infants and premature infants are     necessary to determine treatment and preventative strategies for ROP. This study was designed     to: a) target infants at the highest risk of ROP in a large number of centers with variable     rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus     systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study     is designed to determine whether the novel treatment regimens are safe and potentially     effective for ROP prevention and to obtain requisite data for the development of a Phase III     efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as     standard of care for ELGANs, no placebo group is included.   "
71933|NCT02344212|"     The long-term objective of this study protocol is to develop and test a culturally sensitive,     community-based intervention, ESENCIAL Para Vivir (Essential for Life) to promote weight loss     and diabetes prevention among overweight or obese Latina immigrants. We chose to focus on     Latinas because Latinas are at especially high risk for developing diabetes and currently     there are not Spanish programs available in our area that provide education about weight     management and diabetes prevention.   "
71934|NCT02344199|"     Beta-blockers should be administered to all patients with heart failure stage II to IV     according to NYHA.Beta-blockers reduce mortality and hospitalizations and improve the     operational phase for all categories of patients with heart failure. Since beta-blockers,     only carvedilol, metoprolol, bisoprolol and recently nevimpololi have shown these benefits     and so, only they have evidence to be provided.      Eplerenone is indicated, in addition to conventional therapy, for reducing the risk of     cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction     (LVEF ≤ 40%) and clinically proven heart failure after recent myocardial infarction.   "
71935|NCT02344186|"     The main objective of the study will be to test the hypothesis that treatment with     Liraglutide will decrease ER stress and adipose tissue in obese patients with type 2     diabetes. Experimental Approach: The investigators will use a prospective, single blind,     placebo controlled study design to study 12 obese patients with type 2 diabetes mellitus     (T2DM). 6 patients will first receive Liraglutide for 24 weeks followed by placebo for 12     weeks. The other 6 patients will first receive placebo for 12 weeks followed by Liraglutide     for 24 weeks.      Measurements: The investigators will determine glycemic control (with HbA1c), body     composition (bioelectric impedance analysis), insulin sensitivity (with     hyperinsulinemic-euglycemic clamps), insulin secretion (with oral glucose tolerance testing),     energy balance (calories in vs. calories out), plasma lipid levels and obtain subcutaneous     fat biopsies to determine ER stress response markers before and after placebo and before and     after Liraglutide treatment.   "
71936|NCT02344173|"     The purpose of this registry is to assess the performance and clinical effectiveness of a     combination of SJM mapping and ablation products in the treatment of subjects with atrial     fibrillation (AF).   "
71937|NCT02344160|"     The objective of the study is to demonstrate non-inferiority of stem revision rate in     subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5     year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as     outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.   "
71951|NCT02343965|"     Each year, 17000 cases of severe hematological diseases are diagnosed in France, with more     than 6,000 of these requiring hospitalization in a protective, sterile environment. New     methods, such as touch massage, have emerged in response to anxiety symptoms observed in     patients in such sterile and isolated surroundings. We hypothesize that during the period of     isolation, touch massage becomes a nursing care which can help the patient.   "
71938|NCT02344134|"     The purpose of this study is to describe the immunogenicity and safety of the cell     culture-derived influenza vaccine compared with the egg-derived influenza vaccine among     subjects.      To describe the immunogenicity, antibody levels are evaluated by hemagglutination     inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.      To describe the safety, the time of onset and duration of local and systemic solicited     adverse events are assessed and reported. Unsolicited adverse events and serious adverse     events are collected and categorized throughout the study period.   "
71939|NCT02344121|"     Analysis to quantify intra-fraction, inter-fraction and post-treatment changes in tumor     target volumes and surrounding normal organs in radiation therapy.   "
71940|NCT02344108|"     Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is     associated with adverse behavior and quality of life, as well as long term cardiopulmonary     system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder,     with a incidence of approximately 1 per 660-800 births. Patients with Down Syndrome have a     higher incidence of OSA than the general pediatric population, with rates of 30-60%,     resulting in increased morbidity and decreased quality of life for affected individuals. In     children, adenotonsillectomy (T&A) is often a contributing factor to OSA, and     adenotonsillectomy is a first line treatment. Children with Down Syndrome often undergo T&A     for obstructive sleep apnea, however 30-50% will have persistent obstructive sleep patterns     requiring continuous positive pressure airway support (CPAP) or tracheotomy. Persistent     obstruction is attributed to anatomic and physiologic differences in this population,     including reduced muscular tone, macroglossia, maxillary hypoplasia, and lingual tonsil     hypertrophy. This pilot study is designed to determine if the Inspire® Upper Airway     Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved     under P130008 for the treatment of obstructive sleep apnea, which has already been approved     for use in adults with OSA, can be safely implanted and used in adolescents and young adults     with Down Syndrome.   "
71941|NCT02344095|"     The investigators aimed to evaluate the safety of weekly paclitaxel with oncothermia and     weekly cisplatin with oncothermia in patients with recurrent or persistent epithelial     ovarian, fallopian tube or primary peritoneal carcinoma. This trial is a randomized phase 1     trial. The investigators planned to perform it for 1 year. In this trial, a total of 12     patients with recurrent or persistent epithelial ovarian, fallopian tube or primary     peritoneal carcinoma are randomly assigned to either a paclitaxel or cisplatin group in ratio     of 1 to 1. Paclitaxel group are treated with weekly paclitaxel and oncothermia. Cisplatin     group are treated with weekly cisplatin and oncothermia. In each group, limiting toxicity is     evaluated after treating 3 patients for 4-cycles. Primary endpoint is occurrence of limiting     toxicity. Secondary endpoints are response rate, progression-free survival, overall-survival,     quality of life, pain, fatigue and compliance rate.   "
71942|NCT02344082|"     This prospective study will include both an intervention and control arm. The control arm     will receive face-to-face pharmacy clinic visits per standard of care. The intervention arm     will receive pharmacy clinic visits plus additional telephone follow-up. Patients with a     hemoglobin A1c in the last 3 months greater than 9% will be eligible. Eligible patients must     have a primary care physician at Johns Hopkins Outpatient Center (JHOC) or East Baltimore     Medical Center (EBMC).      Purpose: To compare the change in hemoglobin A1c over the 3 month study period in the     intervention group in which patients participate in telemedicine, to a control group in which     they do not   "
71943|NCT02344069|"     Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage     needing haemostatic resuscitation - a randomized, controlled, double-blinded     investigator-initiated pilot trial   "
71944|NCT02344056|"     The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study     Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch     versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive     functions in the afternoon. The present Coco study connect this two previous studies and     investigates the effect of having school lunch versus skipping it on children's basal and     executive cognitive functions later in the afternoon.   "
71945|NCT02344043|"     Purpose of the Study Critical illness requiring life support affects over 150 000 people in     Ontario every year. With aggressive support, the number of people who die from critical     illness is decreasing. However, people who survive often have neurological problems. These     neurological problems often include difficulties with memory, concentration, and attention.     These problems are associated with poor quality of life among survivors of critical illness.     The aim of this study is to identify the factors that contribute to these neurological     deficits. Specifically, the investigators are testing whether changes in oxygen delivery to     the brain during critical illness are related to both short- and long-term neurological     complications.      Procedures involved in the Research When patients are diagnosed with a critical illness such     as shock or respiratory failure, they are treated with intravenous fluids, medications to     raise their blood pressure, and can be placed on a ventilator to assist with their breathing.     They are observed in an intensive care unit (ICU). This research protocol does NOT interfere     with the normal treatment of patients with critical illness. The procedure involved in this     research protocol requires the placement of two stickers to either side of the patient's     forehead, and information about oxygen delivery to the brain will be recorded. When the     patient has recovered from the critical illness, they will be asked to perform several     neurological tests. Some of these tests will be done with a pencil and paper, while others     will use a robotic device to test arm movements, reaction time, and concentration.      Potential Harms, Risks or Discomforts:      This research study involves the placement of a sticker sensor to either side of the     forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor     patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be     removed. With regards to the neurological testing, rarely patients can have some mild muscle     stiffness after moving their arms in the robot. The investigators do not expect any other     further harms, risks, or discomforts.   "
71946|NCT02344030|"     Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal     CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled     blade   "
71947|NCT02344017|"     The purpose of this first-in-man study is to evaluate safety, tolerability and     pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.   "
71948|NCT02344004|"     A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) when added     to multi-drug regimen in subjects with Nontuberculous Mycobacterial (NTM) lung infection     caused by Mycobacterium Avium Complex (MAC).   "
71949|NCT02343991|"     The purpose of this study is to evaluate the safety of BBB disruption using transcranial     MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to     increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the     ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic safety     of this type of treatment as the basis for later studies to evaluate its clinical efficacy.   "
71954|NCT02343926|"     Primary Objective:      To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to     metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.      Secondary Objectives:      To compare the safety and tolerability of gemigliptin and vildagliptin:        -  Number of patients who experience at least one episode of hypoglycemia.        -  Number of patients experiencing adverse event (AE), serious adverse event (SAE).        -  Assessment of patients compliance defined as number tablets returned by patients.   "
71955|NCT02343913|"     This study is an additional component of protocol 6005, titled Simplifying Menstrual     Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for     follow-up to menstrual regulation service provision in Pakistan. The study seeks to pilot a     self-assessment checklist that will help women, who receive medical services for incomplete     abortion, correctly identify warning signs and symptoms and determine whether to return to     the clinic. The checklist can serve as a useful resource to help with the timely     identification of women who need additional care and can help streamline service delivery. In     addition, this study will provide important data on the role of misoprostol at varying levels     of health services offering an array of treatments for incomplete abortion.   "
71956|NCT02343887|"     Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients     show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms     impact the compliance of the treatment, though its performance and daily life quality. To     this day, no therapy tested has proved its efficiency, including the strategy of the     antiretroviral therapy (cART) optimization according to the Cerebral Penetration     effectiveness Score (CPE).      Description of the study: an open prospective comparative monocentric pilote study,     randomised in three groups which investigates the efficiency of a 6 months-cognitive     rehabilitation program on improving asymptomatic or minor cognitive disorder for undetectable     HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART with a good     cerebral penetration who develop asymptomatic or minor cognitive disorders connected to HIV     infection. Those who have severe psychiatric disorder or who are on medication that could     interfere with psychometrical tests will be excluded.      Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months     period on the evolution of minor cognitive disorders and asymptomatic patients to a control     group and a group treated with psychological support.   "
71957|NCT02343874|"     The prevalence of alcohol-related disorders in the general population is around 10%. The     relationship between the use of healthcare services, costs and the amount of alcohol consumed     by the general population is unknown. Because alcoholism is a major public health problem, it     is significant to determine the prevalence of consumption of primary users and the     relationship between the dose of alcohol and health care costs. This information may allow     the implementation of preventive strategies to reduce consumption with the aim to reduce     morbidity and healthcare expenditure.      A cross-sectional study will be carried out. Patients over 17 years old, treated at primary     healthcare centers in Catalonia that have available data on alcohol consumption from January     2010 to December 2012 will be included. Clinical and sociodemographic data will be collected.     Health service use and health care costs from 2013 will be collected from SIDIAP (The     Information System for the Development of Research in Primary Care) database.      A positive relationship between grams of alcohol consumed per week and the use of resources     and health expenditure will be expected and also the level of risk of alcohol consumption.     There will be a descriptive analysis of the clinical data and sociodemographic variables. A     multivariate analysis will be done to see the relationship between alcohol consumption and     health care costs and health care service utilization.   "
71958|NCT02343861|"     Atopic dermatitis is the most common chronic inflammatory skin disease in children and     severely affects quality of life (QoL) of patients and their parents. The application of     topical medications and emollient is the mainstay of the treatment, but complexity of the     treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic     failure. Adequate education about the chronic disease and its treatment was known to improve     the treatment adherence. There are a variety forms like generalized information leaflets and     video clips for imparting information to patients and individualized tailoring education was     considered more effective way to improve patients' adherence. The aim of this study is to     determine the efficacy of tailored education in dermatology area, especially the emollient     usage in patients with atopic dermatitis.   "
71959|NCT02343848|"     The association between physical activity and several complication of pregnancy will be     evaluated .   "
71960|NCT02343835|"     This protocol will study the impact of Irreversible electroporation (IRE) on immune response     in patients diagnosed with unresectable pancreatic cancers smaller than 5.0 cm. It will     profile the immune response to IRE of unresectable pancreatic cancers. The intra-tumoral and     systemic immune response to IRE will be determined and compared to pre-ablated pancreatic     cancer specimens and historical control specimens.   "
71961|NCT02343822|"     To determine the ideal dose of PRP for lateral epicondylitis. To see if 2 PRP injections are     better than a single PRP injection or a saline injection to improve function and pain in     patients with lateral epicondylitis.   "
72081|NCT02342457|"     Children with chronic constipation, suspected of having hirschsprungs disease, who are     admitted for rectal biopsy will be included in the study. During the procedure,     electrophysiological reading from the site chosen for biopsy will be done. Correlation     between electrophysiological data and histopathology will be analyzed.   "
71983|NCT02343536|"     The goal of the study is to identify a dose and schedule of CC-486 that can be safely     administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the     maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide,     doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more)     previously untreated DLBCL or Grade 3B FL.      Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination     with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International     Working Group (IWG) criteria.   "
71984|NCT02343523|"     The present study proposes to utilize a novel, wearable device, QI Device, which has multiple     sensors embedded in a wrist-watch in order to explore its monitoring capabilities in     individuals with congestive heart failure.   "
71985|NCT02343510|"     PCR for chlamydia DNA is done in paraffin blocks of cases of primary tubal cancer and is     compared to cases of high grade serous ovarian cancer and normal tubes .   "
71962|NCT02343809|"     Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to     the mechanical pain of the locomotor system. In our clinical practice a favorable effect is     observed in patients with chronic lateral epicondylitis, but there are no published studies     evaluating the results of this technique.      The objective of this trial is to evaluate if DF provides a further improvement in pain     intensity, pain-pressure threshold, function and pain-free grip strength, in patients with     chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct     a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care     Center.      Sixty subjects will be randomized (computer application) into three groups: Intervention     Group, Placebo Group and Control Group. All the three groups receive the same protocolized     treatment of physiotherapy and additionally. Additionally, the Intervention Group receives     six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group     receives six sessions (two sessions in a week during three weeks) of sham DF. The Control     Group receives the protocolized treatment of physiotherapy only.      Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH     questionnaire) and pain-free grip strength (digital dynamometer) will be measured at     baseline, after treatment period, and three months after discharge from treatment. After     discharge for treatment the patient subjective opinion about their evolution will be     collected through the Global Rating of Change (GROC) scale.   "
71963|NCT02343796|"     The purpose of this study is to determine whether fibre-reinforced composite resin     restorations are effective for single tooth replacement, elimination of tooth mobility     following periodontal treatment and as an orthodontic retainer.   "
71964|NCT02343783|"     The purpose of this study is to characterize the cell (the basic building block of all living     things) populations and inflammatory (pain and swelling) mediator responses in suction skin     blister fluid after allergic skin reaction (ASR) [rash] induction with D. Pteronyssinus     [house dust mite (HDM)], Alternaria alternata, or Aspergillus fumigatus allergens in     participants with atopic dermatitis (AD) [Skin rash, Eczema] or allergic asthma (AA)     [breathing disorder in which there is a wheezing and difficulty breathing].   "
71965|NCT02343770|"     Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The     etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular     JIA with antinuclear antibodies affects about half of all children. There 's no specific     markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human     Protein Microarray allows rapid and efficient detection of protein interaction using a     suitable protein or small molecule probe. The investigators hope so detect novel potential     autoantigen biomarkers specific in JIA.   "
71966|NCT02343757|"     The early detection of a preclinical AD or early stage of AD with amyloid imaging could     improve the diagnosis and provide knowledge for better therapeutical approach by combining     the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET     imaging, all these two techniques with their strengths in one machine.      Specific Aims and Hypotheses can be summarized as follows:        1. To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI,          including direct comparison to corresponding PET/CT images of the same patients.        2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to          2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque          burden correlate with degree of neuronal degeneration as depicted by FDG as well as with          clinical severity?        3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form          PET/CT and from PET/MR) using novel software developed specifically for these brain          application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid   "
71967|NCT02343744|"     The purpose of this study is to examine descriptively the efficacy of CNTO 1959 in     participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).   "
71968|NCT02343731|"     Studies show that family members share as much or more of the composition of their microbiota     (the trillions of micro-organisms in our guts) with their dogs as they do with each other     (Song et. al. 2013). This shows that the introduction of dogs into home environments has a     profound impact on the human microbiota. Additionally, many studies show that children raised     with dogs are less likely than others to develop a range of immune-mediated disorders,     including asthma and allergies (Ownby, Johnson, and Peterson 2002; Almqvist et al. 2003;     Havstad et al. 2011). This suggests that dogs can serve as probiotics for children by     appropriately training their immune systems not to produce inflammation in response to     harmless stimuli. What is not known, however, is whether the same is true for elderly     populations and dogs. Thus, this study seeks to explore whether dogs might also improve the     physical and mental health of elderly adults by improving the structure and function of their     microbiota. The investigators propose a pilot/proof of concept study to investigate whether     dogs might improve the physical and mental health of elderly adults via changing (improving)     the structure and function of their microbiota (gut flora). The investigators propose a     pre-post study design that among 20 elderly individuals (aged 50 and older) to investigate     the probiotic effect that dogs might have on these individuals. The investigators are     particularly interested to know whether introducing a dog into a home where one has not lived     in the recent past increases the positive microorganisms in the guts of the humans living     with them. The investigators will also measure the changes in markers of inflammation (from     blood samples) as well as the changes in self-reported scores of depression, frailty,     physical activity, and general health and well-being mobility among human participants. In     order to assess any effects in the animal study participants, the investigators will also     collect and analyze fecal and blood samples as well as conduct home visits to observe canine     and human interactions and bonding and conduct assessments of canine well-being using     questionnaires/observational techniques that have been validated for these purposes in other     studies. Additionally, the investigators will assess the interactions between of the     participants with the dog and how having a dog in the home may influence an individual's     relationship with the dog and his/her thoughts about the microbiota, human and canine health     and human-animal interactions through monthly semi-structured interviews.      The investigators have previously received IACUC approval for this study, approval number     14-537.   "
71969|NCT02343718|"     The purpose of this study is to determine the best dose of vinblastine that can be given with     a new drug, temsirolimus.   "
71970|NCT02343705|"     The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella     Knee Implant System for the reduction of medial osteoarthritis knee pain.   "
71982|NCT02343549|"     All patients will complete best standard of care radiation, temozolomide and bevacizumab (6     weeks). Within two weeks of completion of this initial treatment period, study patients will     be fitted with the NovoTTF-100A System and treated continuously. They will be treated with     TTFields for 12 months for an average of 18 hours per day. The patient may elect to take a     treatment break for a total of 3 days per month, for each month and still be in compliance.     This will consist of wearing four electrically insulated electrode arrays on the head. The     patients will also continue with maintenance temozolomide/ bevacizumab.   "
72095|NCT02342275|"     The purpose of this study is to compare the efficacy of orally administered propranolol     versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.   "
71971|NCT02343692|"     Up to 13.5% of patients that undergo a magnetic resonance imaging (MRI) scan of their abdomen     without pancreatic symptoms are found to have an incidental pancreatic cyst, with the     frequency increasing with age. In a post-mortem series, 25% of patients had a pancreatic     cyst, of which 32% were potentially premalignant and 3% malignant. Premalignant cysts are     currently either observed or removed surgically according to international guidelines.     Observation is associated with significant anxiety for patients and a growing cost to the     National Health Service, while surgery for this usually benign condition is associated with     not insignificant morbidity and mortality. Premalignant pancreatic cysts may be indolent for     a number of years before malignant transformation, creating a window of opportunity for     minimally invasive intervention and cure. New early treatment options for premalignant     tumours are urgently required. This study will evaluate the safety and efficacy of a novel     minimally invasive technique for the treatment of pancreatic cystic tumours; endoscopic     ultrasound guided radiofrequency ablation (EUSRFA).      If successful it will offer an alternative to long term observation or surgery for patients     with this condition.   "
71972|NCT02343679|"     This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref     hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim     analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least     one dose of study drug will be evaluable for safety. Only subjects who complete at least 1     cycle of study drug and have clear progression on physical exam or have had at least one     restaging study will be considered evaluable for response. Each subject will receive the same     dose of 750mg po daily at the study entry. Subjects with stable disease or better will be     allowed to continue study drug until disease progression or until intolerable adverse events     or patient or physician decision. Intrapatient dose reductions will be allowed for adverse     events. This is a multicenter study with Duke as the lead site. Blood and tissue samples,     will be collected and used for exploratory analysis.   "
71973|NCT02343666|"     This pilot phase I trial studies the side effects and best dose of human immunodeficiency     virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are     undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected     from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are     then re-infused into the patient. These genetically modified stem cells may help the body     make cells that are resistant to HIV infection.   "
71974|NCT02343653|"     The purpose is to investigate the effect of strength training on muscle strength, muscle mass     and nutritional status in patients with liver cirrhosis to clarify possible metabolic and     inflammatory changes during this intervention. In addition the investigator examine if the     intervention is associated with fewer hospital readmission and an improved quality of life.   "
71975|NCT02343640|"     The purpose of this study is to use ultrasound imaging to determine if there are certain     frequencies, durations, and intensities of baseball pitching that expose a college baseball     player to increased risk of injury to their ulnar collateral ligament of their elbow     throughout one baseball season.   "
71976|NCT02343627|"     This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in     patients with mild-to-moderate fungal infection of the toe nail.   "
71977|NCT02343614|"     The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable     natural history of the disease. Although contemporary treatment options are limited, new     targets and new approaches are under investigation for preventing bladder cancer recurrence     and progression. Among those, COX-2 is a promising target since plays an important role in     urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively     inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in     vivo models.      Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in     patients with intermediate risk NMIBC.   "
71978|NCT02343601|"     The purpose of this study is to determine whether hemodynamic optimization with     photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery     could decrease the incidence of perioperative complications.   "
71979|NCT02343588|"     The study was designed as a national multi-centered cluster randomized controlled trial     involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in     China. In each center, about 12-16 primary and secondary schools, with totally at least 10000     participants were randomly selected (Primary: Secondary=1:1). All of the selected schools     were randomly allocated to either intervention or control group (Intervention:     Control=1:1).The multi-components school-based and family-involved scheme was conducted     within the intervention group for 9 month, while students in the control group followed their     usual health practice. The intervention consisted of four components: a) Create supportive     school and family environment, b) Health lifestyles education and related compulsory physical     activities, c) Instruct and promote school physical education, d) Self-monitor obesity     related behaviors. Four types of outcomes including anthropometric, behavioral, blood     chemical and physical fitness were measured to assess the effectiveness of the intervention     program.   "
71980|NCT02343575|"     Delirium is the most often encountered psychiatric diagnosis in the general hospital, with     incidence up to 85% in the intensive care unit (ICU) setting and with significant     consequences on patients' morbidity and mortality. Currently, although not FDA approved,     antipsychotics are often considered the first-line pharmacological treatment. However, there     can be limitations to their use, including side effects or lack of efficacy. Valproic acid     (VPA) is one of the alternatives at times used in such patients which from limited case     series data appears to be helpful and tolerated. VPA can provide relief from agitation that     poses a threat to the safety and recovery of the patient. Moreover, mechanistically it     addresses the neurochemical and cellular abnormalities inherent in delirium (it has     NMDA-antagonist, anti-dopaminergic, GABAergic,anti-inflammatory, anti-apoptotic, and histone     deacetylase inhibitor properties, among others). The purpose of this study is to evaluate the     efficacy and tolerability of the VPA in the first known to us randomized controlled trial.   "
71981|NCT02343562|"     Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The     objective of the trial is to prevent postoperative HAEC by using Probiotics.   "
71986|NCT02343497|"     The purpose of this study is to investigate whether astaxanthin supplementation can impact     triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.   "
71987|NCT02343484|"     Many different minimally invasive techniques have been used for the treatment of chronic     discogenic low back pain refractory to conservative treatments, with various results. The aim     of this study is to assess the efficacy of the combination of intradiscal pulsed     radiofrequency and gelified ethanol versus gelified ethanol alone, on pain and quality of     life of patients sufferring from chronic discogenic low back pain.   "
71988|NCT02343471|"     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.     Identification of a simple diet-related method will possibly result in reduction of CVD in     healthy as well as high-risk subjects.      The aim of this project is to investigate the effect whey protein consumed as pre-meal prior     to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48) in subjects     with type 2 diabetes compared to healthy subjects. Secondarily the aim is to study the     responses of glucose, insulin, glucagon, amino acids, inflammatory markers, incretins, rate     of gastric emptying and metabolomics. Also satiety feeling will be measured.      Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich     isocaloric meal reduces triglyceride- and ApoB48 responses more in type 2 diabetic subjects     compared to healthy subjects.      The investigators research will hopefully contribute to a better understanding of how PPL can     be modified in a simple manner. It will promote innovation to the food industry for     development and production of healthy food products, which can be applied in the fight     against CVD in the background population in general and high-risk people in particular. Thus,     the results of this project can impart knowledge of great importance both to the national and     international food industry as well as the healthcare systems.   "
71989|NCT02343458|"     A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI;     PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with     placebo.   "
71990|NCT02343445|"     The goal of the study is to evaluate the safety and tolerability of P-1037 and to determine     whether the combination of P-1037 with hypertonic saline or P-1037 alone has a greater effect     on lung function in patients with CF than placebo (0.17% saline).   "
71991|NCT02343432|"     This study was aimed to investigate the impact of using different epidural volumes.      Patients with acute discogenic pain were included in the study.   "
71992|NCT02343419|"     The aim of the study is to compare standard spirometric evaluation of methacholine challenge     test with plethysmographic, interrupter technique and forced oscillation technique (FOT)     evaluation of the airways resistance.      The study group will consist of patients referred for methacholine challenge test. All     patient will undergo spirometric, plethysmographic, interrupter technique and FOT     examinations - before and after inhalation of aerosols. Patients will also undergo the     measurement of nitric oxide concentration in exhaled air and laboratory tests, including:     blood count, measurement of serum C-reactive protein, sodium, potassium, creatinine,     immunoglobulin E and N-Terminal pro-brain natriuretic peptide (NT-proBNP) concentration.      The investigators intend to assess, if plethysmographic, and/or interrupter, and/or FOT     measurement of bronchial reactivity can replace standard spirometric assessment.     Plethysmography, interrupter technique and FOT are much more easier to perform for patients.     Furthermore, those two techniques are less dependent on patient's motivation and cooperation     ability. Thus, usage of FOT, interrupter technique and/or plethysmography in bronchial     hyperreactivity testing could make methacholine challenge test more comfortable and available     for more patients. The investigators are also going to analyze the relationship between     exhaled nitric oxide and functional indices of bronchial hyperreactivity.   "
71993|NCT02343406|"     This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide     versus temozolomide or lomustine alone in participants with recurrent glioblastoma     multiforme.      The study includes a Pediatric sub-study to evaluate safety, tolerability and     pharmacokinetics of ABT-414 in a pediatric population.      Adult enrollment has been completed and the study is now only recruiting for pediatric     participants.   "
71994|NCT02343393|"     This is a single-blind, randomised, clinical trial assessing the efficacy of Hydralazine and     Isosorbidedinitrate combination (oral agents) in HF patients with renal dysfunction.   "
71995|NCT02343380|"     The investigators aim at analyzing whether eating a standard meal in the evening (at 8:00 pm)     determines in the same individuals a lower diet-induced thermogenesis (DIT) and a different     hormonal response than the consumption of the same meal in the morning (at 8:00 am).      The primary outcome is: the intra-individual variation in DIT after the evening and morning     meal consumption.      The secondary outcomes are the intra-individual variations in glucose, triglyceride, insulin,     free fatty acids, leptin, glucagon-like peptide-1, acylated ghrelin, adrenalin, noradrenalin,     after the evening and morning meal consumption.   "
71996|NCT02343367|"     The H4K Trial is a randomized controlled trial to improve children's body composition by     testing a comprehensive, culturally and linguistically relevant, family-oriented intervention     for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San     Antonio, Texas. The H4K trial will test the efficacy of a 6-month pediatric obesity     management intervention (physician counseling plus telephone counseling, newsletters and text     messages) compared to standard care (physician counseling only) on three outcomes: 1) body     composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and     cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and     consumption of sugary beverages and fruits and vegetables. The investigators will recruit 230     overweight and obese children—and a parent or guardian for each—and randomize them to the H4K     intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). The     investigators hypothesize that intervention children will significantly improve their body     composition, increased their PA levels and diet quality (more fruits and vegetables and less     sugary beverages), and decrease their sedentary activity, compared to children in standard     care. If successful, this study will generate new scientific knowledge about effective     Hispanic family-based approaches for obesity prevention with high potential for replication     in underserved areas across the nation.   "
71998|NCT02343341|"     Project 1. Primordial/primary behavior change in children      Problem: Childhood obesity has more than doubled over the past 30 years, with nearly     one-third of children aged 6 to 11 years being obese. These children are more likely to     become obese adults and are at a higher risk for the development of diabetes, hypertension,     heart disease and cancer.      Approach: This research tests the hypothesis that habits are formed very early in life and     that children can help their parents live healthier lives. The investigators attempt to test     this hypothesis by evaluating the impact of an educational program focusing on diet, physical     activity, knowledge of the human body, and management of emotions for preschool children aged     3 to 5 years, their parents/caregivers and teachers. The investigators will first assess the     environmental factors, facilitators, and barriers to implementation of a health promotion     educational program tailored for preschoolers in Harlem, New York. This information will be     used to tailor the educational program for the children in Harlem. The investigators will     evaluate the effectiveness of the program in children aged 3 to 5 years by randomly assigning     blocks of schools to an up to 5-month educational and playful health promotion intervention     or to usual curriculum. The program will also have components for teachers and parents of     these children in order to make their learning environment conducive to positive change. The     impact of our program will be assessed on children's knowledge, attitudes, habits, weight,     exercise and diet using simple questionnaires and measurements.      Impact: The investigators expect to demonstrate a positive impact on knowledge, attitudes and     habits in preschool children in an under-served population. Also aim is to demonstrate that     this early educational program can increase the proportion of preschool aged children with     normal weight. This approach has the potential to meaningfully modify the projected rise in     obesity and cardiovascular disease by affecting an entire generation of children. The     investigators believe that the healthy habits that the children will acquire through this     program will lead them to be healthier adults. Thus, the mission aligns closely with the     American Heart Association's mission of, Building healthier lives, free of cardiovascular     diseases and stroke.   "
71999|NCT02343328|"     The investigators wish to compare Fecal Microbiota Transplant (FMT) capsules to placebo     capsules in subjects with TWO episodes of C. difficile. The investigators have numerous     subjects and physicians requesting FMT at the time of a second relapse, in order to prevent     further hospitalizations, obtain a faster and more durable cure, avoid costly medications     like fidaxomicin and oral vancomycin, and fix the underlying dysbiosis. In some instances,     subjects feel like they are being asked to get sick again before they can pursue the most     effective option. The investigators propose to study these subjects with a rigorous placebo     controlled design, which will contribute significantly to our understanding of the utility of     FMT, timing, and the real relapse rates in a tertiary referral center. Subjects who relapse     with placebo will by definition have a third episode, meet consensus criteria for FMT, and     will be offered standard FMT by capsule at that time. Additionally, this study will allow     us to further capture safety data, in comparison to placebo capsules and further enhance our     understanding of the microbiology of dysbiosis, earlier on in the illness course. Lastly, the     investigators may decide to perform a cost analysis.   "
72000|NCT02343315|"     The purpose of this study is to compare the added effects of TENS and Supervised Motor     Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain     and other outcomes.   "
72001|NCT02343302|"     A very common complication following distal pancreatectomy is leakage from the pancreas, or     what is called a pancreatic fistula. We hypothesize that operative drains which create     suction may contribute to the development of leakage from the pancreas. This study evaluates     the effect of using non-suctioning drains to prevent the development of this complication.   "
72002|NCT02343289|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     esketamine administered by the intranasal (administered through the nose) and oral routes and     to evaluate the effects of clarithromycin on the pharmacokinetics of intranasally     administered esketamine.   "
72003|NCT02343276|"     Single-center study, randomized, double-blind, placebo controlled, with patients undergoing     diagnostic or therapeutic catheterization via the transradial approach. Patients will be     randomized into two groups: one group will receive the vasodilator nitroglycerin during the     procedure (intervention group), and a second group will receive saline 0.9% in the same     volume and time during the procedure (control group).      Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure     without the need to change the access site, pain presented by the patient, time and total     radiation of the procedure.   "
72004|NCT02343263|"     The purpose of this study is to evaluate the effect of combining two interventions already in     use at some institutions for reducing post-operative pain following tonsillectomy or     adenotonsillectomy. The standard of care at most institutions is to leave the tonsillectomy     wound bed exposed to heal on its own over one to two weeks. At many institutions, surgeons     inject or topically apply local anesthetics such as bupivacaine hydrochloride to the     tonsillectomy wound bed to help reduce post-operative pain. At other institutions, surgeons     apply a layer of fibrin sealant, which is derived from the proteins that help form blood     clots in blood, to the tonsillectomy wound bed in order to cover the site and reduce     irritation and exposure of the wound bed. Use of fibrin sealant has the additional benefit of     potentially reducing postoperative bleeding (hemorrhage) rates. Both the post-tonsillectomy     use of bupivacaine (injection and topical) and the use of topical fibrin sealant application     have been studied previously in the scientific literature; some studies show a clear benefit,     others show no significant reduction in pain when they are used. No studies have documented     harm. The purpose of this study is to evaluate the efficacy of infusing bupivacaine     anesthetic into the fibrin sealant prior to application to the tonsillectomy wound bed. In     this way, the combined product would function as a sort of medicated bandaid covering the     painful wound bed and slowly delivering an entirely safe total dose of bupivacaine into the     wound bed to reduce post-operative pain. Parents will be provided post-operative pain     measurements to complete during the first 10 postoperative days and return to the researchers     for data analysis.   "
72005|NCT02343250|"     A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the     Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan     160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers   "
72006|NCT02343237|"     The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic     treatment on patients with fibromyalgia.   "
72007|NCT02343224|"     This is a phase II study of the drug, pegylated interferon alfa-2b (PEG-IntronTM), used to     treat brain tumors in a pediatric population. Researchers want to see if treatment with     PEG-IntronTM will stop tumor growth for patients with juvenile pilocytic astrocytomas or     optic pathway gliomas.      The purposes of this study are:        -  To learn more about the response to pegylated interferon        -  To learn more about the side effects of pegylated interferon        -  To learn more about MRI images in patients with Juvenile Pilocytic Astrocytomas or Optic          Pathway Gliomas.        -  To learn more about quality of life in patients treated with pegylated interferon   "
72008|NCT02343211|"     Paraneoplastic Neurological Syndromes (PNS) are rare remote effects of cancer, not directly     attributed to mass lesions, metastases, infections, ischemia, coagulopathy, metabolic     disruptions or tumour treatment. Currently, PNS treatment is mostly limited to tumour     treatment. Because of an initial inflammatory stage early in the evolution of the PNS several     immunotherapy modalities have been tried. Intravenous human immunoglobulins could be expected     to provide a stabilization or even improvement of PNS, if administered early enough to     prevent permanent neuronal damage.   "
72009|NCT02343198|"     The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following     total knee arthroplasty. Measures of interest: lower limb venous hemodynamics, joint range of     motion, lower limb swelling, walking speed, quality of life, activities of daily living,     device usability, device compliance, activity levels, and pain (VAS).   "
72010|NCT02343185|"     This study is a double-blind randomized clinical trial with two arms which aims to study the     effects of diaphragmatic treatment in patients with nonspecific low back pain.      Low back pain has a great importance in today's society, and it is therefore important to     develop an effective treatment for this condition. People with chronic nonspecific low back     pain, can present respiratory disorders and get anxiety states, affecting mainly the     diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be     part of the development of chronic low back pain. Although clinical practice guidelines for     chronic low back pain have been developed, it hasn't been explored before a physiotherapy     treatment especially aimed at a diaphragmatic treatment.      A double-blind randomized clinical trial with two arms will be used for this purpose, 64     patients with nonspecific low back pain referred from different hospitals of Castellón will     be randomized into two groups:        -  Diaphragmatic intervention with osteopathic manual therapy treatment (D).        -  Diaphragmatic intervention with placebo treatment group (P).      An osteopathic manual therapy protocol for the treatment of back pain including techniques     for the diaphragm muscle will be applied to the patients in group D, in a total of 5     sessions. For patients in group P, the same protocol will be performed on the diaphragm but     with placebo treatment techniques.      The study focuses on the analysis of the following variables: scores on the questionnaires:        -  Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ).        -  Fear Avoidance: (FABQ)        -  Disability: Oswestry Disability Index and Roland-Morris        -  Anxiety: HADS: (Hospital Anxiety and Depression Scale)        -  Catastropizing: PCS (Pain Catastropizing Scale)        -  Satisfaction with treatment (Escala de Satisfacción con el tratamiento)      The results of these pre-intervention and post-intervention variables will be compared     between the two groups in the first session, in the fourth session and in the first and third     month after the first intervention. The VAS score will also be assessed in the second and     third session.   "
72011|NCT02343172|"     To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the     combination is safe and has beneficial effects in patients with liposarcoma.   "
72012|NCT02343159|"     The primary objective of the study is to determine whether a Medication Event Monitoring     System (MEMS®) cap with a liquid crystal display (LCD) reader (a smart cap) along with     additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate     (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an LCD     reader (a standard cap) and no patient counseling intervention (standard of care, Arm 1) at     Month 12.      The secondary objectives of this study in this study population are: to determine if data     display on a smart MEMS cap with an LCD reader (Arm 2) can improve adherence as compared to a     standard MEMS cap without an LCD reader (Arm 1) at Month 12; to determine whether the     addition of patient counseling intervention based on MEMS data (Arm 3), or data display from     a MEMS cap with an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap     without an LCD reader (Arm 1) at Month 6; to assess persistence and compliance at Months 6     and 12 for all arms; to assess the association between adherence and patient- reported     outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the     Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.   "
72034|NCT02341833|"     The aim of the investigators study is to investigate the effects of anaesthetic     preconditioning with sevoflurane during organs harvesting in brain dead donors. More     particularly, the investigators will investigate whether sevoflurane preconditioning protects     against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of     cold ischaemia and whether this protection translates in a better clinical functional     recovery of these allografts.   "
72013|NCT02343146|"     The incidence of type 1 diabetes (T1D) in young children (age <5 years) is rising. The burden     of responsibility for disease management rests on parents and caregivers to check blood     sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic     control. This occurs at a vulnerable time in life when children's behavior is unpredictable,     their T1D is difficult to control, and parenting stress is elevated. Despite behavioral     interventions that have demonstrated success in reducing rates of parent stress and improving     child behavior, improvements in young children's glycemic control has not been sufficiently     achieved. The investigators' research will attempt to achieve this goal through the     development and pilot of an innovative behavioral intervention for T1D in parents of young     children. The focus of the intervention is on improving young children's nutrition and     physical activity through the use of parent consultants and delivery of intervention through     phone and text messaging. The study will be conducted in two phases. In Phase 1, 10 primary     caregivers of young children (<5 years) diagnosed with T1D for at least 6 months will receive     the intervention and then be assessed at 3- and 6- months post baseline on indices of     behavior and glycemic control (including continuous glucose monitoring). Participants will     also complete in-depth surveys to provide qualitative as well as quantitative data. At the     end of Phase 1, the data will be analyzed and used to develop the intervention further for     Phase 2. During Phase 2, 60 participants and their children will be randomized to either the     revised intervention (treatment) or usual care (control) condition. Intervention components     include: T1D management support delivered by trained lay parent consultants, and T1D     parenting strategies specific to improving eating and physical activity behaviors delivered     by bachelor's level behavioral assistants via telephone and text messaging. Biomedical and     psychosocial measurements (including HbA1c, physical activity, nutrition, mealtime behavior,     parenting stress, quality of life) will occur at baseline and 3- and 6-months post baseline.     The results of this work will ultimately lead to a program which can improve young children's     T1D management and glycemic control that can be translated into a variety of clinical     practice settings.   "
72014|NCT02343133|"     The purpose of this study is to determine whether HemaMax is safe and well tolerated to     support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated     with the hematopoietic syndrome of acute radiation syndrome.   "
72015|NCT02343120|"     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment     effect of a new drug known as BGB-3111 in patients with B-Cell Lymphoid Malignancies.   "
72016|NCT02343107|"     Abdominal obesity and its metabolic consequences, particularly type 2 diabetes, require     personalized nutritional monitoring. Today, it is not always possible to provide patients     with appropriate care to both, the diet plan, physical activity, stress and sleep management.     Emerging data have shown the effectiveness of remote support (e- coaching), in order to     increase the level of physical activity and reducing calorie intake which causes weight loss     similar to that obtained during a face to face consultation. Compared to a food survey     conducted by a dietician, the dietary survey MXS computer software showed similar results on     the collection of nutritional data. Furthermore, users preferred this method of remote     collection compared to direct interview. The investigators recently developed a tool for     e-coaching combining this computerized dietary survey and education and support modules on     diet and physical activity (MXS- health program) for the patients. The aim of the     investigators' study is to compare efficacy of this new software vs usual care.   "
72020|NCT02342015|"     Background: Circulating osteoprogenitors and RANKL expression in immune cells have been     implicated in the pathogenesis of osteoporosis and vascular calcification. The role played by     statin therapy in the bone-vascular axis is unknown.      Methods: Twenty naïve post-menopausal osteoporotic hypercholesterolemic women will be treated     with Atorvastatin 40 mg/day for three months. Blood samples will be collected at baseline and     at the end of the treatment. Gene expression analysis will be performed to assess     modification in OPG/RANK/RANKL expression in isolated T-cells and monocytes. A flow cytometry     analysis will be used to study changes in the levels of circulating osteoprogenitor cells.   "
72021|NCT02342002|"     The purpose of the proposed study is to compare - in a randomized, placebo-controlled,     double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used     alone for missed abortion.   "
72022|NCT02341989|"     One course of adjuvant carboplatin AUC7 is considered internationally to be a standard     treatment option in clinical stage I seminoma, regardless of risk factors. Treatment is based     on a large, randomized phase III study comparing adjuvant carboplatin with adjuvant     radiotherapy. This study was done without registering data on possible risk factor for     relapse. The relapse rate following carboplatin was in this study estimated to be 5.3 %. Data     from a prospective, risk-adapted Spanish study showed that patients without risk factors had     a very low risk of relapse, even without adjuvant treatment. This result is also confirmed by     a recent analysis of SWENOTECA VII data, showing that this group of patients has a risk of     relapse of less than 5 % without adjuvant treatment.      Combined data from SWENOTECA V and VII studies indicate a high risk of relapse in patients     with one or two risk factors (tumor 4 cm, stromal invasion of rete testis) treated with one     course of adjuvant carboplatin. The relapse rate in this group of patients was 9.4 %,     indicating a very modest effect of one course of adjuvant carboplatin. If adjuvant     chemotherapy is the preferred treatment strategy, more potent chemotherapy regimens should be     explored in this patient group. The results from SWENOTECA III/VI studies with one course of     cisplatin-based adjuvant chemotherapy in clinical stage I nonseminoma, show a very low rate     of relapse. As seminoma is even more chemosensitive than nonseminoma the relapse rate     following one course of adjuvant BEP is expected to be very low, close to 1 %.      The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse     rate than one course of adjuvant carboplatin AUC7. In addition, it will be investigated if     there is a difference in health related quality of life as well as acute and long-term     toxicities from treatment.   "
72023|NCT02341976|"     To study which position on the whole body vibrator machine would stimulate the pelvic floor     muscles.   "
72024|NCT02341963|"     The purpose of this pilot study is to test the safety of oral ketamine to treat acute pain     after amputation surgery. The objective of the proposed research is to conclusively determine     if oral ketamine is a safe alternative analgesic to opioid for acute pain in subjects     undergoing elective amputation of the lower extremity. All participants will receive oral     ketamine.   "
72035|NCT02343055|"     The overall objective of this study is to evaluate a collaborative self-management     intervention in patients with moderate to severe COPD in a primary care population. To     achieve this objective the investigators developed a diagnostic and treatment pathway for the     management of COPD in primary care that is based on national guidelines and focused on     patient self-management.   "
72036|NCT02343042|"     This study will independently assess the efficacy and safety of four combination therapies     for the treatment of patients with relapsed/refractory multiple myeloma (RR MM): selinexor +     pomalidomide + dexamethasone (SPd), selinexor + bortezomib + dexamethasone (SVd), selinexor +     lenalidomide+ dexamethasone (SRd), and selinexor + daratumumab + dexamethasone (SDd). The     abbreviations for combination treatments have been revised to use V (Velcade) for bortezomib     and R (Revlimid) for lenalidomide.   "
72025|NCT02341950|"     This study will evaluate the efficacy of a newly developed serious game, SCI HARD, to enhance     self-management skills, self-reported health behaviors, and quality of life among adolescents     and young adults with spinal cord injury and disease (SCI/D). SCI HARD was designed by the     project PI, Dr. Meade, in collaboration with the UM3D (University of Michigan three     dimensional) Lab between 2010 and 2013 with funding from a NIDRR (National Institute on     Disability and Rehabilitation Research) Field Initiated Development Grant to assist persons     with SCI develop and apply the necessary skills to keep their bodies healthy while managing     the many aspects of SCI care. The study makes a unique contribution to rehabilitation by     emphasizing the concepts of personal responsibility and control over one's health and life as     a whole. By selecting an innovative approach for program implementation, we also attempt to     address the high cost of care delivery and lack of health care access to underserved     populations with SCI/D living across the United States (US).      H1: SCI Hard participants will show greater improvements in problem solving skills, healthy     attitudes about disability, and SCI Self-efficacy than will control group members; these     improvements will be sustained over time within and between groups.      H2: SCI Hard participants will endorse more positive health behaviors than control group     members; these improvements will be sustained over time within and between groups.      H3: SCI Hard participants will have higher levels of QOL than control group members; these     differences will be sustained over time within and between groups.      H4: Among SCI Hard participants, dosage of game play will be related to degree of change in     self-management skills, health behaviors and QOL.   "
72026|NCT02341937|"     Patients with cancer have a high risk of deep vein thrombosis which often develops in the     veins of the lower limbs. The initial evaluation of clinically suspected deep vein thrombosis     includes the estimation of the clinical probability by calculating risk scores such as the     Wells score and the measurement of the D-dimer. However, the usefulness and accuracy of the     clinical scores and d-dimer test are lower in patients with cancer who often undergo     unnecessary (serial) ultrasonography.      The aim of the current study is to analyze variables that predict the presence of thrombosis     and may improve the accuracy of the Wells score. In addition, various cut-off of the d-dimer     will be evaluated with the goal of improving the sensibility and specificity of the test.   "
72027|NCT02341924|"     The objective of this research project is to investigate the ability to affect cardiovascular     disease (CVD) risk factors through a novel, easily implemented functional food-based     approach. The goal of the proposed project is to evaluate the effect of a range of     proprietary products specifically formulated to deliver convenient pre-packaged     condition-specific foods to positively impact blood cholesterol levels in statin intolerant     and/or statin unwilling participants. The specific aim of this project is to evaluate the     changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose,     insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen     using healthy tasty foods which are self-selected by a statin intolerant patient group.   "
72028|NCT02341911|"     Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast     Cancer (TNBC)   "
83061|NCT02198794|"     The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of     SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe     tardive dyskinesia.   "
72029|NCT02341898|"     Background: Physical restraints as bedrails and belts are still regularly applied in German     nursing homes despite clear evidence showing their lack of effectiveness and safety. In a     cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent     intervention has been shown with a significant reduction in physical restraints use without     adverse events. The present study aims to apply different versions of the original     intervention in nursing home residents in four different regions throughout Germany in order     to evaluate the effectiveness of the programme.      Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention     groups ((1) updated original programme and (2) brief version of the updated programme) with a     control group (3) receiving printed study materials (optimized usual care). Intervention (1)     consists of an information programme for all nurses, additional training and structured     support for nominated key nurses, and provision of printed study material and other     supportive material. For intervention (2) nurses' training is only optional carried out     facultatively by key nurses who have received an additional train-the-trainer module. The     control group (3) receives printed study material only. Overall, 120 nursing homes including     approximately 10800 residents will be recruited, randomized to one of the three groups and     followed up for 12 months. The primary outcome is defined as proportion of residents with at     least one physical restraint at 12 months. Physical restraint use will be assessed by direct     observation. Secondary outcomes are residents` quality of life as well as safety parameters     as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.   "
72030|NCT02341885|"     A prospective international, multi-centre, prevalence study on the epidemiology of the use of     renal replacement therapy for ICU patients who have acute kidney injury and chronic end stage     kidney disease.   "
72031|NCT02341872|"     The purpose of this study is to determine whether Fluoride varnish + calcium (Clinpro White     Varnish) and polipeptide solution (Curodont Repair) are effective in the treatment of     remineralization therapy. The investigators will diagnose their alone or in combination     effects on white spot lesions. Aesthetics (tooth-colored), remineralization, microbiological     effects will be evaluated separately. Spectrophotometer (Vita Easy Shade) , Quantitative     Light Fluorescence (QLF), Diagnodent(Cavo Diagnodent) and culture methods in microbiology     laboratories are used for aesthetic, remineralization and microbiological assessments. The     measurements will be made baseline, 6 weeks, 3 months and 6 months later after the     applications and recorded.   "
72032|NCT02341859|"     Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and     DAILIES TOTAL1®   "
72033|NCT02341846|"     This interview and focus group study will explore patient, caregiver, and health professional     opinions about the potential roles of digital technology to support effective cancer pain     management. The views, opinions, and ideas expressed in this study will be used to design and     develop a digital intervention which is likely to take the form of a measurement (pain and     analgesic use) guided medication management intervention to improve cancer pain management in     the community.   "
72037|NCT02343029|"     Physical activity exerts a variety of long-term health benefits in older adults.This     randomised controlled trial investigates the effect of a 12-week physical exercise program on     the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging.     Follow-up lasts for 6 months.   "
72039|NCT02343003|"     This study is designed to:        -  Determine the effectiveness (primarily measured by pain relief) of Coolief when used to          create radiofrequency lesions of the genicular nerves compared to pain relief following          corticosteroid injection; and        -  Confirm the safety of Coolief when used to perform radiofrequency lesions of the          genicular nerves in subjects to manage knee pain compared to safety of corticosteroid          injection   "
72040|NCT02342990|"     Periventricular Leukomalacia (PVL) is a white matter lesion surrounding the lateral     ventricles of the brain occurring in the prenatal period, associated with a disorder of     movement and posture, known as bilateral cerebral palsy. Children with PVL and bilateral     cerebral palsy have spared verbal abilities, as measured by verbal Intelligence Quotient     (verbal IQ) tests, while non-verbal intelligence and especially visuo-perceptual and     visuo-spatial abilities are impaired. In addition some studies underline the impact of PVL     also on executive function, especially in terms of working memory and in the ability to     inhibit distraction.      Working Memory is the ability to retain and manipulate information for brief periods of time.     It is important in several complex cognitive functions, such as academic learning and in     planning and organizing daily life activities. School-based activities, indeed, such as math     and reading depend on a student's ability to pay attention to several instructions or     information and to hold and integrate them in their mind.      Recent behavioural and neurofunctional studies describes the effect of an evidence-based and     computer-based training on working memory, the Cogmed Working MemoryTraining. Functional MRI     show increase in parietal and prefrontal activity after this training, while the behavioural     data demonstrate the generalization of this effect also on cognitive functions not directly     trained, as attention, inhibition, learning and non-verbal reasoning. Cogmed Working     MemoryTraining (RoboMemo®, CogMed-Cognitive Medical Systems, Stockholm, Sweden) is an online     treatment comprising a number of visuo-spatial and verbal exercises that vary automatically     depending on the individual child's performance in any given task. The training period is     intensive and includes 25 home session for five weeks, 30-45 minutes each day. A     Cogmed-trained coach monitors training progress and participants' commitment daily.      Only one ongoing study has used the CogMed training in children with cerebral palsy, but     without investigating the correlation between behavioural findings with neurofunctional data.      The aim of this study is to analyze the effect of the working memory training with CogMed on     trained and not directly trained cognitive abilities and on the changes in cortical     electrophysiological reorganization during the sleep after training. The sleep analysis will     be focused in particular on the slow waves activity [frequency range of 1-4.5 Hz] and on the     sleep spindle [frequency range of 12-14Hz], which reflect the depth of sleep and are related     to memory processes, learning and brain plasticity.      The results of this project will shed light on the mechanisms of neuroplasticity, by     enhancing knowledge on the neuropsychological effects of a specific working memory training     and on the neurophysiological underpinnings of these behavioural effects in a clinical     population of children with congenital brain lesions, as PVL.   "
72041|NCT02342977|"     The purpose of this study is to determine how effect lacosamide is in reducing the amount of     pain medication needed following a total hip arthroplasty. The study team hypothesizes that a     single dose of lacosamide will reduce the amount of pain medication required after surgery.     The study team plans to evaluate the amount of pain medication needed and quality of pain     control during a subject's hospital stay and at their three month follow-up visit following     their surgery.   "
72042|NCT02342964|"     Non-invasive methods of the quantification of fibrosis may help to assess the development of     fibrosis at a specific moment of the evolution of the disease, in the order to decide the     initiation of treatment with ursodeoxycholic acid which may slow the progression to hepatic     cirrhosis:        -  FibroTest,        -  The ultrasound impulse elastography, Fibroscan (FS)        -  Ultrasound Elastography by ShearWave (SWE)        -  Magnetic resonance elastography (MRE). The purpose of this study is to assess the          contribution of these methods in the diagnosis of hepatic fibrosis during the evolution          of the cystic fibrosis.   "
72043|NCT02342951|"     The purpose of this study is to determine the efficacy of a non invasive method of detecting     the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as     possible.      Moreover this screening procedure permits to note the improvement following the treatment and     to choose the optimal treatment in term of efficacy.   "
72044|NCT02342938|"     The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with     either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients     suffering from drug-resistant partial epilepsy, and 2) define the functional organization of     neural networks underlying human perception and cognition in order to prevent inadvertent     deficits resulting from neurosurgical resection. In particular, high-frequency activity     (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for     both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG     require further investigation. This will be a pioneering effort in several respects, as the     first to directly measure high-frequency neural activity in tandem with fMRI, and among the     first to do so with MEG. In addition to their attractiveness as noninvasive imaging     techniques, fMRI and MEG have the potential to examine whole-brain networks that are not     accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of     simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the     two noninvasive techniques, providing compelling evidence for the links between all three     measurements with respect to underlying high-frequency neural activity in both health and     disease. This project will therefore lead to improved selection of epilepsy surgery     candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and     healthy brain networks. The same techniques will be immediately applicable to functional     mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of     neurological and psychiatric populations.   "
72045|NCT02342925|"     This single-center, non-randomized, open-label, two treatment, two period, fixed sequence     crossover study will investigate the effect of RG1662 treatment on the activity of key renal     transporters in healthy male and female participants using metformin. The effect of RG1662 on     other renal function parameters will also be explored.   "
72046|NCT02342912|"     This is a randomized trial designed to translate and deliver programs via social media for a     healthy body weight to university students. Specifically, in this trial, we will randomly     assign 450 overweight/obese (BMI between 25-45kg/m2) university students (ages 18-35)     enrolled at two colleges (George Washington University and University of     Massachusetts-Boston) to one of two social media weight loss treatments (personalized or     generic) or a contact control. The social media treatments consist of Facebook groups to     provide social support, connectedness and intervention content, as well as daily text     messages. Assessments will be conducted at baseline, 6, 12, and 18 months post baseline, with     the primary outcome being weight loss at 18 months. We hypothesize that: a) Tailored Social     Media will lose significantly more weight at the above time points compared with Targeted     Social Media. b) Both the Tailored Social Media and Targeted Social Media groups will have     greater weight loss at the 6, 12, 18 month follow-ups than Contact Control. The secondary aim     is to evaluate changes in metabolic risk factors among those participants who have maintained     at least 5% weight loss at 18 months. We hypothesize that participants who achieve a 5%     weight loss at 6 and 18 months will have significantly lower triglycerides, higher HDL     cholesterol, and lower blood pressure than those who do not achieve and maintain that weight     target. Finally, we will conduct additional formative work to evaluate the implementation     feasibility of this intervention on college campuses, including an assessment of costs as     well as the sustainability infrastructure using the PRISM (Practical, Robust Implementation     and Sustainability Model) model as a guide. The results of this study have the potential to     significantly impact the delivery of obesity treatment services on college campuses.   "
72047|NCT02342899|"     Obesity is an escalating issue, with an accompanying increase in referrals of patients with     obesity-related respiratory failure. Currently, these patients are electively admitted to     hospital for initiation of non-invasive ventilation (NIV), but it is unknown whether     outpatient initiation is as effective as inpatient set-up. The investigators hypothesise that     outpatient set up using an auto-titrating NIV device will be more cost effective than     nurse-led inpatient titration and set-up.      The investigators will undertake a multi-national, multi-centre randomised controlled trial.      Subjects will be randomised to receiving usual inpatient set-up, which will include nurse-led     initiation of NIV or outpatient set-up with an automated NIV device. Subjects will be     stratified according to trial site, gender and previous use of NIV or continuous positive     airway pressure. Assuming 10% drop out rate, a total sample of 82 patients will be required.     Cost effectiveness will be evaluated using standard treatment costs and health service     utilisation and using health related quality of life measures (SRI and EQ5D). Change in the     severe respiratory insufficiency (SRI) questionnaire will be based on analysis of covariance     (ANCOVA) adjusting for the baseline measurements between the two arms of patients.   "
72048|NCT02342886|"     The purpose of this study is to assess the efficacy, safety and tolerability of a combination     of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths     from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard     HRZE treatment.      This study will also assess the efficacy, safety and tolerability of a combination of     moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects     with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin,     PA-824, and pyrazinamide treatments in DS-TB subjects.   "
72049|NCT02342873|"     The investigators compared the postoperative analgesia of nerve stimulator-guided and     ultrasound-guided interscalene block after shoulder surgery.   "
72050|NCT02342860|"     The investigators will conduct a cluster-randomized trial to assess the impact of a     school-based water, sanitation and hygiene program on health and educational outcomes of     school children in Saravane Province, Laos. The intervention will include an improved water     supply (borehole), a sanitation block that includes three pour-flush latrines with rainwater     harvesting to be used for flushing and a urinal, and sinks for handwashing with soap. The     school will also receive a facility for group handwashing (large pipe where many children can     wash hands at once. United Nations International Children's Emergency Fund (UNICEF) will     additionally provide behavior change education. Our key outcome of interest is pupil absence,     which will be measured longitudinally using roll-call on days of schools visits. Secondary     outcomes include self-reported absence, diarrhea and respiratory infection of a random     selection of students. The investigators will also monitor the fidelity of the intervention     and assess school conditions and pupil sanitation and handwashing behaviors using structured     observation.   "
72385|NCT02338271|"     1. Subject: 10 patients           : Chronic low back pain patients with lumbar intervertebral disc degeneration        2. Investigational Product           : Autologous adipose derived mesenchymal stem cells plus hyaluronic acid derivatives          (Tissuefill)        3. Time frame             -  1 year   "
72051|NCT02342847|"     This is an observational, post-authorization, prospective follow-up, multi-centre, national     study designed to describe the spectrum of health-related quality of life in patients with     metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to     observe patients treated in routine clinical practice, without the exclusion limitations of a     clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to     treat patients will be performed prior to the decision to include the patient in the study.      Given the observational nature of the study, follow-up of patients will be performed     according to standard clinical practice of each site.   "
72052|NCT02342834|"     The purpose of this study is:        -  to measure the size of the effect on glucose tolerance of a small mixed protein and          lipid meal given as a pre-load in individuals with different glucose tolerance status        -  to investigate the underlying mechanisms by accurately evaluating beta cell function,          insulin sensitivity, insulin clearance and glucose kinetics (oral absorption, endogenous          production, rate of utilization) together with gut hormones plasma concentration.   "
72053|NCT02342821|"     This Study will attempt to provide information / linkage to HBV care for persons at risk in     the Greater Boston area.   "
72055|NCT02342795|"     The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the     influence of novel tobacco products on biomarkers of toxicant exposure and disease risk,     reports of adverse events, and concurrent use of other tobacco products. In this case, the     novel products are one type of electronic cigarette and an imitation cigarette or cigarette     substitute.   "
72056|NCT02342782|"     This phase I trial studies the side effects and best dose of yttrium Y 90 basiliximab when     given together with standard combination chemotherapy before a stem cell transplant in     treating patients with mature T-cell non-Hodgkin lymphoma. Radioactive substances linked to     monoclonal antibodies, such as yttrium Y 90 basiliximab, can bind to cancer cells and give     off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as     carmustine, cytarabine, etoposide, and melphalan (BEAM), work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving yttrium Y 90 basiliximab and chemotherapy before a stem     cell transplant may help kill any cancer cells that are in the body and help make room in the     patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells that were     collected from the patient's blood and stored before treatment are later returned to the     patient to replace the blood-forming cells that were destroyed.   "
72104|NCT02342158|"     PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number     patients with locally advanced or metastatic cancer for whom identification of molecular     alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will     enroll 460 patients in 3 years.   "
72368|NCT02338492|"     The purpose of this study is to collect safety and performance data of the Photodynamic Bone     Stabilization System (PBSS) when used for the treatment of painful impending and actual     fractures of the humerus secondary to metastatic cancer.   "
72057|NCT02342769|"     TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose     combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures     in the practice of HIV care in Germany. The primary study objective is a descriptive report     of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ     therapy in everyday routine practice in Germany. The study is designed to enroll     approximately 400 patients. There are no protocol-mandated visits or procedures associated     with the study. Each patient is expected to participate for a maximum of 3 years or until     premature discontinuation (i.e., discontinuation of TRIUMEQ, due to death, withdrawal of     consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of     companies.   "
72058|NCT02342756|"     The use of positive end-expiratory pressure (PEEP) has been shown to prevent the cycling     end-expiratory collapse during mechanical ventilation and to maintain alveolar recruitment,     keeping lung portions open, increasing the resting end-expiratory volume. On the other hand     PEEP may also overdistend the already open lung, increasing stress and strain.      Theoretically high frequency oscillatory ventilation (HFOV) could be considered an ideal     strategy in patients with ARDS for the small tidal volumes, but the expected benefits have     not been shown yet.      PEEP and HFOV should be tailored on individual physiology. Assuming that the esophageal     pressure is a good estimation of pleural pressure, transpulmonary pressure can be estimated     by the difference between airway pressure and esophageal pressure (PL= Paw - Pes). A PL of 0     cmH2O at end-expiration should keep the airways open (even if distal zones are not certainly     recruited) and a PL of 15 cmH2O should produce an overall increase of lung recruitment.      The investigators want to determine whether the prevention of atelectrauma by setting PEEP     and mPaw to obtain 0 cmH2O of transpulmonary pressure at end expiratory volume is less     injurious than lung recruitment limiting tidal overdistension by setting PEEP and mPaw at a     threshold of 15 cmH2O of transpulmonary pressure.      The comparison between conventional ventilation with tidal volume of 6 ml/Kg and HFOV enables     us to understand the role of different tidal volumes on preventing atelectrauma and inducing     lung recruitment.      The use of non-invasive bedside techniques such as lung ultrasound, electrical impedance     tomography, and transthoracic echocardiography are becoming necessary in ICU and may allow us     to distinguish between lung recruitment and tidal overdistension at different PEEP/mPaw     settings, in order to limit pulmonary and hemodynamic complications during CMV and HFOV.   "
72059|NCT02342743|"     The purpose of this pilot study is to assess the efficacy of the Cefaly device in the     treatment of chronic migraine prior to implement a control trial where the size and final     protocol will be specified thanks to the outcomes of this pilot trial.   "
72060|NCT02342730|"     This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or     patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see     a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or     obesity is one of the most common contributors to (causes of) endometrial cancer. Over     two-thirds of women who have survived endometrial cancer are obese. Complications of obesity,     such as heart disease are often more dangerous than the cancer itself. A weight loss of even     5-10% of excess body weight is associated with improved health. Often, meeting with a doctor     or person who is an expert in weight loss (bariatric specialist) is the best way to lose     weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia     who go see a weight loss specialist recommended by their doctor may be able to achieve a     healthier body weight.   "
72061|NCT02342717|"     To investigate whether and to what extent co-administration of multiple doses of itraconazole     affect single dose pharmacokinetics of BI 425809 in healthy male subjects   "
72386|NCT02338258|"     The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of     the long tubular bone after treatment of Intramedallery nailing   "
72062|NCT02342704|"     The primary objective of this study is to assess the effect of natalizumab compared to     fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to     persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this     study population are to assess the effect of natalizumab compared to fingolimod on: magnetic     resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as     measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity;     No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in     information processing speed as measured by the Symbol Digit Modalities Test (SDMT).   "
72063|NCT02342691|"     The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME,     topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by     the incidence of adverse events, including mucosal inflammation and irritancy and findings     from safety labs. Subjects will be monitored for development of periodontitis, and oral flora     will be analyzed to detect an increase in opportunistic organisms.      The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring     changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP)     and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF).      The study comprises three groups in a randomized, placebo-controlled double-blind clinical     trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group     will each include 50 subjects. The no-rinse control group will consist of 25 subjects.     Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or     placebo) to be applied once daily after morning teeth brushing. Safety parameters will be     assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be     assessed before and after 14 and 28 days of treatment.   "
72064|NCT02342678|"     The LILA study is a pilot randomized parallel-group trial of a group-based yoga therapy     program versus physical conditionin control program for treatment of urinary incontinence in     ambulatory middle-aged and older women. Women aged 50 years and older who meet the criteria     for frequency of incontinence episodes, are not using other clinical treatments for     incontinence, and meet minimum physical mobility requirements and other eligibility criteria     will be recruited from the general San Francisco Bay Area.   "
72065|NCT02342665|"     The primary objective of this study is to assess the safety profile of copanlisib at the     recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese patients     will be determined in the dose escalation/safety evaluation part   "
72066|NCT02342652|"     This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2     multiple dose cohorts of healthy elderly subjects.      The purpose of the study is to determine the safety, tolerability and pharmacokinetics of     ASLAN003 in healthy elderly male and female subjects.   "
72067|NCT02342639|"     The purpose of this study is to determine if Rifaximin decreases serum and urine levels of     bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to     evaluate changes in the bacterial content of the stool from these individuals.   "
72068|NCT02342626|"     The overall goal of this project is to test an interactive, multi-media decision aid in the     form of an electronic clinical decision dashboard designed to improve the quality of clinical     decision making for initial treatment of patients with newly diagnosed, low or intermediate     risk prostate cancer.   "
72069|NCT02342613|"     This Phase 1 clinical study is designed to examine the safety and feasibility of using     anti-CD3/CD28 activated marrow infiltrating lymphocytes (MILs) as treatment of relapse after     allogeneic hematopoietic cell transplantation (alloHCT) for patients with hematologic     malignancies with bone marrow involvement of their relapsed disease. These MILs will be     derived from the bone marrow of the relapsed patient who had previously received     post-transplantation cyclophosphamide (PTCy) as graft-versus-host disease (GVHD) prophylaxis     (PTCy-MILs). A bone marrow aspiration will be performed on the patient to collect ~200ml of     marrow for ex vivo expansion. During this expansion process, T cells will be activated and     expanded by co-stimulation with anti-CD3/anti-CD28 monoclonal antibodies covalently attached     to super-paramagnetic microbeads. Patients will be treated with salvage therapy while this ex     vivo expansion is ongoing. After the simultaneous salvage therapy and ex vivo expansion, the     activated PTCy-MILs will be reinfused. Patients will be monitored with the primary objective     being the feasibility of expanding to targeted dose levels activated PTCy-MILs that do not     cause grade III-IV acute GVHD within the first 90 days after PTCy-MIL infusion.   "
72070|NCT02342600|"     This study evaluates the combination of trametinib and pazopanib in patients with advanced     gastrointestinal stromal tumors (GIST).   "
72071|NCT02342587|"     Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved     for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or     amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and     protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of     tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium,     germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.      Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both     ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor     may provide improved therapeutic benefit compared with inhibitors that target only one or the     other receptor.      Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients     with HER2-positive refractory cancer.   "
72072|NCT02342574|"     Double blind, placebo controlled, parallel group ascending dose study evaluating single and     multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the     objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and     potent antifungal agent for the treatment of invasive aspergillosis, will be delivered     intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real     time. Safety and tolerability of those schedules will also be assessed.   "
72182|NCT02340936|"     The purpose of the Phase I of the study is to evaluate the safety and the maximum-tolerated     dose (MTD) of the combination R-ESHAP with lenalidomide as salvage therapy for patients with     relapsed or refractory diffuse large B-cell lymphoma The purpose of the Phase II of the study     is to evaluate ORR of LR-ESHAP in patients with relapsed or refractory DLBCL candidates to     HDT and ASCT   "
72073|NCT02342561|"     This study evaluates the effect of Iodine-impregnated self-adhesive plastic drapes (IIAD) on     the quantity of skin bacteria, which is a known factor in the development of surgical site     infections in orthopedic surgery. 16 patients scheduled for total knee replacement surgery     (TKA) are recruited for participation in an intervention performed at the orthopedic ward of     Odense University Hospital, Denmark.      Right or left patient knee is randomized to receive draping with IIAD, while the other knee     is not draped. Local standard preoperative procedure for knee surgery is then simulated.      After 75 minutes both knee are sampled for bacterial quantity using the cup scrub method and     samples are aerobically incubated. The bacterial growth of the IIAD and no-drape group are     then compared using nonparametric statistics.   "
72074|NCT02342548|"     This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following     study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and     tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from     baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC)     assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of     treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of     treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding     A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will     be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15     mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to 260     subjects may take part in this open label extension   "
72075|NCT02342535|"     The goal of this study is to pilot-test a culturally-salient physical activity intervention,     using a randomized design, among under served, overweight/obese South Asian women at high     risk for developing Diabetes.   "
72076|NCT02342522|"     The purpose of this study is to determine whether remote ischemic conditioning can reduce     cardiac death and hospitalization for heart failure in patients presenting with a     ST-elevation myocardial infarction and treated by percutaneous coronary intervention.   "
72077|NCT02342509|"     The new MIRUS system as well as the established AnaConDa system uses a reflector to conserve     volatile anaesthetics (VA). Both systems act with commercially available ICU ventilators. In     contrast to AnaConDa the MIRUS includes an automated control of end-tidal VA concentrations.     In this study the investigators compared feasibility, costs and recovery times after     anaesthesia with isoflurane (ISO), sevoflurane (SEVO) or desflurane (DES) in ventilated and     spontaneously breathing patients.   "
72078|NCT02342496|"     The purpose of this study is to evaluate the ability of a blend of berries and probiotics in     reducing low-grade inflammation and intestinal permeability in the elderly. The intervention     period is one month. Blood and fecal samples will be collected for analysis at baseline and     at the end of the intervention with the aim to analyse possible changes in different     parameters at the two timepoints. The participants will also be asked to keep a study diary     throughout the study period for the documentation of their intestinal health and as a means     for checking compliance.   "
72079|NCT02342483|"     This randomized, double-blind, adaptive design study aims to prove that the     Methylsulfonylmethane study product improves nasal breathing and stuffy nose symptoms after     exposure to environmental allergens. Endpoints include percent change in Peak Nasal     Inspiratory Flow, VAS Nasal Symptom Score, number of sneezes and number of used tissues in     response to allergen exposure.   "
72080|NCT02342470|"     The purpose of this study is to evaluate the efficacy and safety by comparing prevention of     recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.   "
72380|NCT02338336|"     To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine     therapeutic activity against Plantar Warts        -  Clinical Tolerance        -  Clinical Recovery        -  Evaluate Safety   "
72082|NCT02342444|"     The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many     times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing     clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended     by the drug companies. These two doses have never been directly compared in trauma, general,     and vascular surgery patients. The purposes of this study are:        1. to compare the development of blood clots in patients receiving 30mg twice daily of          enoxaparin compared to patients receiving 40mg once daily of enoxaparin.        2. to determine if there is higher risk of bleeding complications in patients receiving          30mg twice daily of enoxaparin compared to patients receiving 40mg once daily.      Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily     or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of     blood clots. At the time of discharge (or before, if medically indicated), an ultrasound test     will be performed to look for blood clots in the patient's legs.      The investigators will compare incidence of blood clots formed between the 2 groups of     patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in     critically ill patients. The investigators will also compare the incidence of bleeding     complications between the 2 groups.   "
72083|NCT02342431|"     The study is a comparison of a patient warming system using a forced-air, non-compressible     under-body mattress (Möck & Möck, Hamburg, Germany) versus a regular forced-air underbody     mattress system during pediatric cardiac catheterization in 40 patients.      The hypothesis is, that the non-compressible mattress provides better warming with less     incidence of perioperative hypothermia (Core temperature < 36 °C) and faster warming slope     (°C / time). The study is prospective, randomized, controlled and single-blinded.      Inclusion criteria will be pediatric patients < 1 year of age without fever or a treatment of     therapeutic hypothermia.   "
72084|NCT02342418|"     This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal     body weight- matched non-obese subjects. Qualifying subjects who have completed an informed     consent will receive a single intravenous dose of tedizolid with the collection of 11 blood     samples over 72 hours post dose.   "
72183|NCT02340923|"     The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on     healthy children and children with duchenne muscular dystrophy so as to develop a new,     convenient tool for the office based assessment of children with a wide variety of     neuromuscular conditions.   "
72085|NCT02342405|"     The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is     much higher than previously assumed, with approximately 10 % of patients undergoing     non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study     furthermore showed that patients treated with a high inspiratory oxygen fraction during     surgery had a higher 1 year mortality compared with patients treated with a low inspiratory     fraction. This was especially significant among patients undergoing cancer surgery. A     possible explanation, is that a high oxygen fraction results in oxidative stress and     endothelial dysfunction.      With this randomized cross-over study we wish to investigate the effect of a high inspiratory     oxygen fraction on the endothelial function among healthy male volunteers. The primary     outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are     changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a     measure for the effect of oxygen on the autonomic nervous system.   "
72086|NCT02342392|"     The purpose of this study is to evaluate the pterygium vascularity and size before and after     intralesional ranibizumab injection and to evaluate its recurrence rate following pterygium     excision surgery.   "
72087|NCT02342379|"     Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy     bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease     progression.   "
72088|NCT02342366|"     The purpose of this study is to determine whether gamma-Hydroxybutyrate (GHB) has prosocial     and prosexual effects in healthy male participants, and to characterize these putative     effects via behavioral tests, functional magnetic resonance imaging (fMRI),     electroencephalography (EEG), and neuroendocrine parameters. The investigators predict that     GHB in fact has prosocial and prosexual effects which can be neurobiologically characterized     using the assessed methods. Such effects would be of high interest for the treatment of     mental disorders which involve impairments of social interaction and sexual function such as     major depression or autism.   "
72089|NCT02342353|"     There are two parts to this study: the goal of the first part of the study is to find the     best dose of pacritinib when given in combination with erlotinib. The goal of the second part     of the study is to look at the response rate of pacritinib and erlotinib when given in     combination.   "
72090|NCT02342340|"     This is a single site, blinded, randomized, controlled study designed to examine     phytochemical absorption, metabolism and excretion, as well as vascular health and satiety,     after ingestion of 4 different bean varieties (pinto, navy, red kidney, black). Eligible     participants will attend 6 in-person clinic visits for comparative testing of the 4 bean     varieties versus lentils and rice.   "
72091|NCT02342327|"     The purpose of this study is to determine if in smokers of menthol cigarettes, switching to     non-menthol cigarettes prior to a cessation attempt results in greater cessation success than     attempting to quit without first switching   "
72092|NCT02342314|"     The study involves a single dose of LY3143753 or LY3185643, given as an injection into the     abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The     study is approximately 12 weeks for each participant, not including screening. Screening is     required within 28 days prior to the start of the study. This study involves Part A     (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose     level.   "
72093|NCT02342301|"     We aim to determine if changing a person's workstation from a traditional seated desk to a     height adjustable standing desk for a period of approximately 3 months is associated with     alterations in traditional measures of cardiometabolic risk.   "
72094|NCT02342288|"     A rare but terrible complication of vision loss has been known to occur after surgery,     including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is     one of the reasons for this rare vision loss. It has been shown that the prone position can     increase the IOP, and that tilting the patient with the head down can also increase IOP. The     investigators will be measuring IOP before, during, and after a posterior spine surgery to     see if the investigators can influence the intraocular pressure with elevated head position     change. Two groups will be studied: one group of patients will receive standard care with the     head in neutral position, while the other group will have the head slightly elevated 10     degrees during prone spine surgery.   "
72096|NCT02342262|"     RATIONALE: The prevalence of migraine is higher in patients with various intestinal diseases.     An explanation could be that migraine is caused by a 'leaky gut': an increased intestinal     permeability that allows food particles to pass the gastrointestinal wall. Probiotics may be     able to improve intestinal barrier function.      OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and severity     of migraine attacks by reducing intestinal permeability.      STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected     probiotics.      STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION:     Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2 grams of the     placebo, containing only the carrier material (both provided by Winclove Probiotics).      MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and severity of migraine attacks, measured by     diaries and validated headache questionnaires will be measured at baseline and after 4, 8,     and 12 weeks of probiotic/placebo administration. Secondary, intestinal permeability will be     measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12     weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed     from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks).     Fecal samples will also be used for microbial analysis.   "
72097|NCT02342249|"     The purpose of this study is to evaluate the antiviral effect, as measured by viral titer in     nasal secretions in adults with acute uncomplicated seasonal influenza A following     administration of VX-787.   "
72118|NCT02341768|"     The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve     life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms     of techniques and medical devices, based on the patient's condition.      It is extremely important in the clinical practice to identify which patients' subgroup     benefits the most from the ICD therapy, which comorbidity has a major impact on the patients'     prognosis, or which pre-intra-post procedural behaviors provoke less complications, and     affect the patient's outcome (including prolonged or unwanted hospitalizations).   "
72098|NCT02342236|"     Postoperative Cognitive Disorders (POCD) are common in hospitalized people > 60 year old,     especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still     remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The     incidence of such events in patients who underwent big joints arthroplasty can be as high as     40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood     flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or     destroyed. After neuronal damage specific substances, such as S100B protein, glial fibrillary     acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the blood. The serum     concentrations of these biomarkers can be measured. Moreover, the block of blood flow will     decrease regional cerebral saturation in affected parts of the brain.      In this project the authors would like to analyze the correlation between the regional     cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic     patients scheduled to primary hip arthroplasty.   "
72099|NCT02342223|"     The purpose of this study is to test the safety of Voluma and see what effects it has on HIV     facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively     impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.   "
72100|NCT02342210|"     Recent research has suggested that mindfulness-based interventions for psychosis may be     effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack     of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and     could lead to improvements in functioning and quality of life. However these findings are     based on small studies that largely consist of patients with chronic illness. Little is yet     known about the use of mindfulness interventions for young people recovering from their first     episode of psychosis.      The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a     12-week facilitated group intervention promoting mindfulness skills and the development of     emotional and social competencies, is an effective, feasible, and acceptable means of     treating youth in the early stages of psychotic illnesses. Although the current study is     hypothesis generating in nature, based on previous investigations of Mindfulness Based     Interventions for psychoses (Chadwick, 2014), we are expecting that participating in the MAC     intervention will result in improvements in clinical, cognitive, functional, and health     service utilization parameters. Additionally, we expect that the MAC intervention will prove     to be acceptable to participants and a feasible intervention for early psychotic disorders.   "
72101|NCT02342197|"     Objective: To compare two stimulation protocols, the minidose long protocol and the microdose     flare protocol designed for low responders undergoing ICSI.      Design: Randomized prospective study. Setting: University hospital IVF unit. Patients: 60     poor responder patients coming for IVF center for ICSI. Interventions: Minidose long protocol     in which half the dose of agonist was administered from the mid luteal phase until the day of     HCG administration was compared with microdose flare protocol in which half the dose of GnRH     was administered from the second day of the cycle until the day of HCG administration. Both     groups received Gn stimulation from the second day of the cycle (300-450 IU).      Main outcome measures: Number of oocytes retrieved.   "
72102|NCT02342184|"     This study will carry out to assess the efficacy of GB-0998 (intravenous     immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome     based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition, to     assess the safety of GB-0998.   "
72103|NCT02342171|"     This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will     evaluate Convalescent Plasma (CP) added to standardized supportive care (SC) in patients with     confirmed Ebola Virus Disease (EVD). No patient will be refused CP when compatible products     are available and all efforts will be made to maximize CP availability during the study. EVD     patients recruited during the period before CP becomes available or for whom no compatible CP     is available will be given SC and will be followed for study outcomes. Data from these SC     patients will be the used as comparator in the analysis of the study. The primary objective     of the study is to assess if CP + SC improves the 14 day survival of patients, compared to SC     alone.      The Investigators aim to enroll a total number of 130 - 200 patients who will be treated     treated with CP assuming equal numbers of patients treated with SC alone. If there would be     insufficient patients treated with SC, patients treated at the research site prior to study     start may be included in the comparison group.      Patients will be recruited in the Ebola Treatment centre managed by Medecins Sans Frontieres     (MSF) in Conakry, Guinea. All patients and/or relatives presenting at the centre will be     informed about the study, and will be invited to provide consent at the time of admission     inside the treatment centre. Only patients for whom ebola infection is confirmed with     polymerase chain reaction (PCR) will be enrolled in the study. After inclusion, eligibility     to the intervention will be reassessed on regular intervals. If the eligibility criteria are     not met by 48 hours after inclusion, only SC will be continued.      In line with the guidance of the World Health Organization (WHO), two units of CP will be     given. EVD patients will be transfused with ABO-compatible CP using standard procedures.     Details on the modalities of transfusion can be found in the WHO guidance document and the     MSF guidelines on blood transfusion. All patients will be under close observation for     transfusion-related adverse reactions during and up to 4 hours after transfusion. 24 hours     after the start of transfusion, a blood sample will be collected for viral load assessment.     All other aspects of patient management will be according to MSF clinical guidelines. The     decision to discharge a patient should be taken on clinical grounds, but can be supported by     the laboratory results. After discharge, the patient will be followed up by the study team     until day 30.   "
72106|NCT02342132|"     Children with neuromuscular diseases (NMDs) and weak chest muscles suffer frequent chest     infections, hospital admissions and reduced life expectancy. Physiotherapy is widely used but     there is limited research data to support choice of therapy. The investigators will study the     clinical value of the three most commonly used chest physiotherapy devices in children with     NMD's by measuring lung function tests before and after each of the three treatments. This is     a pilot study. The best device will be selected for a long term study of early physiotherapy     intervention in children with NMDs.      The treatments that have been developed to break the cycle of decreasing lung volume and poor     secretion clearance, in children with NMDs, are all based on the same logical but unproved     theory of treatment:        1. The loss of lung volume is reversed by applying positive pressure to the lungs via a          face mask - literally reinflating the lungs with pressure. The three devices the          investigators will test all provide positive pressure assistance during the inspiratory          phase.        2. The temporarily increased lung volume then allows higher expiratory flow rates which          helps to clear secretions. The expiratory phase is assisted by manual chest compression          or, in one device, helped by application of negative pressure during exhalation.      All three devices that the investigators wish to compare follow this two-step approach. The     hypotheses behind our study are:        1. Treatments combining positive pressure inhalation with assisted coughing during          exhalation, will produce measurable improvements in lung volume and expiratory cough          flow rates when tested in children with NMDs.        2. One of the three devices tested will be superior to the others. This will provide          research-based justification for a long term study of the value of early intervention in          children with NMDs.   "
72119|NCT02341755|"     This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in     predicting the need for surgery in patients with Crohn's disease and intestinal lesions with     obstructive symptoms.      Patients with known Crohn's disease which were scheduled to perform abdominal CT for     obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome     of surgery. DE-CT parameters were then compared between patients who underwent surgery and     those who did not.   "
72107|NCT02342119|"     Living donor kidney transplantation (LDKT) is the optimal treatment for end-stage kidney     disease (ESKD). But, the evaluation process for a kidney transplant is lengthy, time     consuming, and burdensome to the patient. Also, race disparities exist in rates of transplant     evaluation completion, transplantation, and LDKT. Our previous and ongoing NIDDK-funded     research indicates that cultural factors (i.e., perceived discrimination in health care,     religious objection to LDKT), transplant knowledge, and demographic characteristics (e.g.,     age, education, income) independently and significantly predict time to complete transplant     evaluation. In December 2012 the investigators' transplant center implemented a one-day     streamlined evaluation process, dubbed Kidney Transplant Fast Track (KTFT), but it has not     been evaluated for efficacy or cost effectiveness. Thus, the investigators propose a     quasi-experiment to determine the efficacy and cost-effectiveness of the KTFT (n=1030)     compared to historical controls (n=1140) who were recruited for the investigators' current     NIDDK study to increase transplant rates. At the same time, the investigators will conduct a     randomized controlled trial (RCT) targeting vulnerable patients with the educational     component of the TALK intervention (Talking About Live Kidney Donation) to increase LDKT. For     both components of the proposal, the investigators will target vulnerable populations because     they are most at risk for extended evaluation times and lower rates of LDKT. Using CONSORT     standards, participants will be randomly assigned to TALK (n=515) versus no-TALK (n=515)     conditions and undergo two interviews at pre-transplant work-up and at completion of     transplant evaluation in order to: (1) test whether KTFT and TALK will reduce transplant     evaluation time, and increase rates of transplant and LDKT in members of vulnerable groups;     (2) determine whether engaging in a streamlined and coordinated-care evaluation experience     within the transplant center reduces negative perceptions of the healthcare system; and (3)     test the cost effectiveness of the KTFT with TALK relative to standard practices. The results     of this two-pronged approach will help pave the way for other transplant centers to implement     a fast-track system at their sites, improve quality of care by transplanting a larger number     of vulnerable patients, and may help address stark race/ethnic disparities in rates of LDKT.   "
72108|NCT02342106|"     The investigators will study the immune cell subpopulations in follicular fluid of patients     undergoing In-Vitro Fertilization (IVF) treatment in our clinic. The investigators will     corelate the presence of immature myeloid cells to the ovarian stimulation response as     indicated by follicle stimulating hormone (FSH) and number of follicles or estradiol level     developed on the day of human chorionic gonadotropin (hCG) administration.   "
72109|NCT02342093|"     Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP);     however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This     study has the objective to assess possible differences in BP associated with the use of COCs     containing DRSP with different doses of ethinylestradiol.      Materials and methods: This open-label parallel-group randomized clinical trial involved     women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime,     nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the     beginning of the trial and six months after drug therapy.   "
72110|NCT02342080|"     Patients with incomplete spinal cord injury   "
72111|NCT02342067|"     A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of     Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK     of PGZ administered with and without CVC.   "
72112|NCT02342054|"     High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more     advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and     in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in     terms of biochemical control, patient survival and toxicity, but there are still certain     limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical     trial.      The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality     of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and     intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of     cancer control and satisfaction of the patients undergoing the experimental treatment.      Forty nine patients will be recruited for the experimental procedure Quality of Life,     tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized     procedures and scales. Patient satisfaction with the procedure will be appraised using     five-category predetermined Likert scale questions.      Two different types of intermediate analyses will be performed: with 15 and 30 recruited     patients.      The experimental treatment tested in this study is very innovative. Since prostate cancer is     the most frequent cancer in men in Spain, this trial results are very likely to have a major     impact on the standard therapy for prostate cancer in our National Health Service, allowing     for a higher number of Hospitals within our country and other countries starting protocols of     HDR BT 19Gy in single fraction.   "
72113|NCT02342041|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     SUVN-G3031 in healthy male subjects following single or multiple ascending doses.   "
72114|NCT02341820|"     This project which is fully funded by the European Union FP7 Program is designed to pull     together all the information we obtain from scans and x-rays to design a personalised 3-D     digital model of each patient, their anatomy and disease. We can then use this as follows: as     (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision     support tool to communicate the available treatment options to the patient and facilitate     shared decision making and provision of personalised care and (iii) to enable standardised     objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to     demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer     patients and assess the impact on their care and quality of life.   "
72115|NCT02341807|"     This clinical study evaluates the safety and tolerability of AAV2-hCHM in subjects with     Choroideremia gene mutations. Two dose groups will be evaluated.   "
72116|NCT02341794|"     The purpose of this study is to investigate the effects of rosuvastatin treatment on degree     of intracranial arterial stenosis.   "
72117|NCT02341781|"     The objective of this study is to determine the effectiveness of lenalidomide in subjects     with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL     subjects who require treatment after receiving ibrutinib therapy are considered a population     with high unmet medical need. It is therefore of benefit to have data on the outcomes of     treatment options available in this patient population.      An observational study design was chosen to collect the clinical data already existing or     being collected for MCL subjects being treated with lenalidomide.      MCL subjects who received lenalidomide either as monotherapy or as combination treatment     after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant     to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next     subsequent treatment after ibrutinib.   "
72139|NCT02341495|"     The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia     will go into complete remission (meaning the leukemia is completely gone), and to find out     how long it stays away. The drugs used in this project are FDA approved and commercially     available.   "
72120|NCT02341742|"     This study is an observational study. The purpose of this study is to assess the relationship     between bone health and daily physical activity in children and adolescents with inflammatory     bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD.     Physical activity is an important determinant of health throughout the whole lifespan.     Engaging in regular moderate-to-vigorous physical activity has important health benefits.     Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous     physical activity could improve bone health (ie bone mineral density) in children and     adolescents with IBD.   "
72121|NCT02341729|"     The first aim of the study is to prove that after starting the therapy with crushed tablets,     the platelet inhibition will be as expected after starting therapy with intact tablets.     Gurbel et al. showed that 100% of the patients on ticagrelor treatment have a decrease from     baseline platelet aggregation of >10% 4 hours after last maintenance dose. So the     investigators expect that after 3 days of treatment, all of our patients will have a closing     time of more than 106seconds.      The investigators will observe two different clinical conditions of Acute Coronary Syndrome.     First after semi-urgent coronary artery bypass graft (CABG) surgery, secondly in patients     after cardiac arrest.      Both are clinical situations in which crushed tablets are needed to give. The second     objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX (active     metabolite of ticagrelor) in these two patient populations after receiving 180mg or 90mg     start-dose. Determination of plasma concentrations is done after protein precipitation, by     using liquid chromatography with mass spectrometry detection. Measurements will be determined     before intake (0h) and at 0,5; 1; 2; 4; 8; 24h and at day 4 +4h.7 The first 24h this will be     a crushed tablet and 4 hours after the first intake at day 4 of therapy, this will be a non     crushed tablet.   "
72122|NCT02341716|"     The purpose of this randomized clinical trial is to determine and compare the clinical and     cost effectiveness of three methods for exercise therapy as treatment for patients with     intermittent claudication. The methods tested are a hospital-based (SET) and a home-based     (HET) supervised exercise program and unsupervised walk advice (WA) and all patients are     followed for 12 months. Unsupervised WA consists of advice of at least 30 minutes walking     with Nordic Poles (NP) at least three times per week and this basic treatment, including best     medical treatment, is used in all three treatment groups. In addition to this basic     treatment, the SET group patients during the first six months participate in group-based     exercise therapy in the hospital for 50 minutes three times weekly, supervised by a     physiotherapist. The HET group patients perform the same exercise in their home 50 minutes     three times weekly during six months receiving feedback from a physiotherapist by a phone     call every 14th day. The SET and HET group patients are recommended to continue the 50     minutes three times weekly exercise therapy in their homes without supervision during the     last six months. Primary outcome is change from baseline to 12 months in walking distance     during six minutes in a hospital corridor (6MWT) and co-primary outcome is change from     baseline to 12 months in health-related quality of life (HRQoL) using the SF36 questionnaire.     Secondary outcomes include fulfillment of patient-specified goals with treatment (PSFS),     change in health-related quality-of-life (HRQoL) with a disease-specific instrument     (VascuQoL), walking impairment as measured by the Walking Impairment Questionnaire, physical     activity (accelerometer) and compliance with physical exercise therapy (patient diary).   "
72123|NCT02341703|"     Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia     contributes to chronic anovulation commonly encountered in women with PCOS. The first choice     therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics     and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin     sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve     fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial     thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this     study we will compare the effect of combined letrozole-metformin with that of combined     letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women   "
72134|NCT02341560|"     This study will determine the effect of QPI-1007 on visual function in subjects with     recent-onset NAION and assess the safety and tolerability of intravitreal injections of     QPI-1007 in this population. This study will also evaluate the structural changes in the     retina following administration of QPI-1007.   "
72381|NCT02338323|"     The purpose of this study is to determine whether febuxostat and benzbromarone could protect     renal function, and which one could be better.   "
72124|NCT02341690|"     Type 2 Diabetes (T2D) is one of the most common chronic diseases world vide. Patients with     T2D experiences reduced quality of life and have a lower physical activity level. Physical     activity is well documented treatment to the patient group. The effect of physical activity     is shown to reduce co-morbidity, and better functional level and quality of life.      Interval Walking Training (IWT) is a new and effective exercise type. IWT is done by walking     in a slow and a fast tempo. InterWalk is an application to a smartphone. By using InterWalk     the patient can to IWT independently and when used, the app has, as an exercise tool, the     potential to better the individual functional level and to measure the physical activity     level with the integrated personalised walking test.      Motivation for change of habits and lifestyle is subjectively determined by the individual,     his or hers individual resources and environment. It is important to get insight in these     individual challenges in order to be better structure possible help.      The combination of an exercise log, a measure of physical activity fromInterWalk and insight     in motivational aspects on an individual level, is essential for successful individualised     training.      The primary objective of the study is to investigate if the InterWalk app is more effective     in increasing the physical activity level compared to a standard care offer in a sample of     newly T2D diabetes patients across 52 weeks.      Secondarily, we will investigate if the IW app can reduce sitting time, induce weight loss,     improve glycaemic control, increase quality of life, improve cardio-respiratory fitness and     reduce the use of diabetes medication.      The study is designed to test the hypothesis that replacing a standard exercise program in     the normal municipal standard care with the Interval Walking Training delivered by the IW app     with and without a motivational support program, can increase the long-term physical activity     level in patients with T2D for a period of 52 weeks.      From January 2015 to June 2016 all patient's with T2D, who are referred to the promotion     centres in the municipality, will be offered to participate in the study. In total 513     patients with T2D from different municipalities in Denmark will be included and randomly     allocated into three groups. One group will receive standard care and the two other groups     will do IWT with the InterWalk app. All three groups are followed by the promotion centre for     8-14 weeks (according to the rehabilitation in the municipality) and hereafter only one of     the IWT groups will receive motivational support up to 52 weeks.      All patients, no mater group allocation, will be tested and fulfill questionnaires, three     times during the intervention period - at baseline, after 8-14 weeks and after 52 weeks. The     interventions take place at the promotion centres in the municipalities two times a week and     the patient will be encouraged train by them selves one time a week.   "
72140|NCT02341482|"     The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF     04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.   "
72184|NCT02340910|"     This study will enroll people with SCI who have spasticity and some ability to walk. The goal     is to understand if standing on a platform and receiving WBV results in decreased spasticity     and improved walking ability.   "
72125|NCT02341677|"     The purpose of this study is to determine how well SmartTarget guided prostate biopsies     perform, compared with our current standard of visually directed biopsies in the detection     of prostate cancer.      The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease.     Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the     disease location. Transperineal mapping biopsies overcome this by systematically samples the     entire gland but are very intensive and time consuming to perform.      An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy     can be used to inform doctors about the location of the disease. This is a difficult     procedure to perform as it requires the surgeon to mentally translate the location of disease     on MRI image to the live ultrasound seen in theatre.      SmartTarget may help this procedure by providing guidance to the location of the disease by     fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to     biopsy.      This trial will compare the outcomes of visually directed biopsies with those directed by     SmartTarget   "
72126|NCT02341664|"     The purpose of the Patient and Provider Assessment of Lipid Management Registry (PALM) is to     gain a better understanding of physicians' cholesterol medication prescribing practices,     patient and physician attitudes and beliefs related to cholesterol management, and current     utilization of cholesterol-lowering therapies given the new ACC/AHA guideline     recommendations. The PALM Registry hopes to allow for the design of ways to improve     cholesterol management and decrease the burden of cardiovascular disease (CVD) in the US.   "
72127|NCT02341651|"     High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD).     In rural South Asia, hypertension remains to be a significant public health issue with     sub-optimal rates of case finding and management. A trial to investigate integrated primary     care strategies to control hypertension is planned. Packaged interventions for the planned     full-scale study are varying combinations of 1) home health education (HHE) by trained     community health workers (CHW), 2) trained government primary health centre mid-level     providers (MLP) led care and 3) trained private practitioners. The goal of the full-scale     study is to test which combination of the above interventions is the most effective in     lowering blood pressure among adults with hypertension in rural communities. In addition, the     full-scale study aims to quantify the incremental cost- effectiveness of each approach in     terms of cost per projected cardiovascular disease (CVD) disability adjusted life-years     (DALYs) averted.   "
72128|NCT02341638|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.   "
72129|NCT02341625|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics,     immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and     in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer,     ovarian cancer, pancreatic cancer and gastric cancer.   "
72130|NCT02341612|"     Subjects were randomly placed in five groups: (1) single exposure at 5°C in cold water     immersion, (2) single exposure at 15°C in cold water immersion, (3) multiple exposures at     10°C in cold water immersion, (4) whole body cryotherapy (WBC) at 110°C and (5) passive     recovery (control group). The single exposure groups performed cold water immersion     immediately after exercise-induced muscle damage (EIMD) for 20 minutes. The multiple     exposures group performed cold water immersion immediately, 24h, 48h and 72h after EIMD (once     a day) for 20 minutes. The WBC group remained in the cabin immediately after EIMD for 3 min.     The control group was not exposed to treatment after the EIMD protocol. The subjects were     asked to visit the laboratory on seven occasions. The first visit was the familiarization of     the subjects with experimental procedures and their anthropometric assessment. One week after     familiarization, on visit two, volunteers performed the exercise-induced muscle damage (EIMD)     protocol and they were allocated to one of experimental groups. Indirect markers of muscle     damage and inflammatory responses were evaluated at baseline (pre), immediately post, 24h,     48h, 72h, 96h, and 168h following the EIMD protocol by measuring anterior thigh muscle     swelling, isometric knee extensors peak torque, knee extensors muscle soreness,     countermovement vertical jump and blood sample analyzes.   "
72131|NCT02341599|"     The purpose of this study is to characterize the effect of renal function on the plasma,     urine, and dialysate pharmacokinetic profile of CB-238,618 in humans. The study will also     assess the safety profile and tolerability of CB-238,618 in subjects with varying degrees of     renal impairment and in healthy subjects.   "
72132|NCT02341586|"     The purpose of this research is to determine if cooking with an iron ingot called the Lucky     Iron Fish (LIF) increases the hemoglobin status in women of childbearing age living in Preah     Vihear, Cambodia. The investigators hypothesize that the use of the LIF during cooking over a     12-month period will be as efficacious at increasing hemoglobin concentration as iron     supplements (18 mg elemental iron) and will be more efficacious than the control.   "
72135|NCT02341547|"     This is a prospective, observational, non-inferior study in ESRF patients stable on Eprex who     are switched to a Biosimilar Epoetin Alfa. Study plans to recrut 44 patients. Following     recruitment, a baseline data collection of full routine laboratory test before switch to     Binocrit.Primary endpoint is Mean change in haemoglobin levels at 12 weeks and Secondary     endpoint is Mean change in haemoglobin levels at 6 weeks Safety endpoint will be Adverse drug     reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and Week 12     will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate. Changes     in continuous variables over time were evaluated using repeated-measures analysis of     variance. Patients with iron-deficiency (ferritin <100 ng/ml or transferrin saturation <20%)     will be analysed separately   "
72136|NCT02341534|"     The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the     consequent treatment after detected arrhythmias in patients after acute myocardial infarction     with preserved cardiac function, but other risk factors, decreases the risk of major adverse     cardiac events.   "
72137|NCT02341521|"     An open label study in 9 male and 9 female healthy subjects to determine the pharmacokinetics     of parent compound and metabolite after eight days of dosing.   "
72138|NCT02341508|"     The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in     healthy volunteers. Additional endpoints include characterization of the pharmacokinetic     (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in     healthy volunteers.   "
72141|NCT02341469|"     In 2010, one in six children in Burkina Faso died before the age of five, mainly due to lack     of access to quality health care services. Most of these deaths could have been avoided     through cost-effective interventions. Ensuring that sick children receive adequate care in a     country where 80% of the population lives in rural areas requires improved accessibility and     high quality primary health care services. The Integrated Management of Childhood Illnesses     strategy (IMCI) was developed by the World Health Organization (WHO) and the United Nations     Children's Fund (UNICEF) in the 1990s and is an excellent way to improve the quality of     country's child health services. However, in Burkina Faso IMCI suffers from a low level of     adherence by health workers. According to a recent evaluation by the Ministry of Health     (MoH), only 8.2% of children had benefited in 2012 from an consultation using IMCI guideline.     Moreover, an analysis of children's records showed that only 15% of IMCI consultations were     being correctly delivered and, for instance, only 34% of children with pneumonia who needed     an antibiotic were prescribed the correct treatment. The obstacles to IMCI adoption in     Burkina Faso are diverse and include inadequate training methods, shortage of material     (papers, forms), lack of quality supervision by district executive teams, lack of integration     between IMCI monitoring tools and the national health information system etc.      The Integrated eDiagnosis Approach (IeDA) aims to address the poor quality of child health     services in Burkina Faso by increasing the level of adherence to IMCI guidelines. IeDA is an     innovative strategy combining information and communication technologies (using the Registre     Electronique des Consultations [REC], an electronic IMCI patient record designed by Terre des     hommes, Tdh) and a quality improvement approach. The approach has been piloted over three     years in two different districts in the north of Burkina Faso, Tougan and Séguénéga. This     medium scaling-up demonstration project will combine implementation and research components     with a goal to enable national scaleup.      Terre des hommes is in charge of the implementation of the project and the London School of     Hygiene and Tropical Medicine (LSHTM) will coordinate the research component of the study in     partnership with Centre Muraz.      The primary hypothesis is that the Integrated eDiagnosis Approach will lead to improved     adherence to IMCI guidelines and management of childhood illnesses in two regions (with a     target of 75% of correct diagnoses and prescriptions).   "
72142|NCT02341456|"     This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in     monotherapy and in combination with carboplatin and paclitaxel to Asian patients with     advanced solid tumours.   "
72143|NCT02341443|"     Mandibular fractures represent approximately 50% of the total facial fractures and are     commonly (more than half) presented in more than one location. A few simple fractures can be     treated using a conservative approach. More often, however, mandibular fractures require     stabilization using open reduction and internal fixation.      Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on     the load-sharing principle, by which stabilization is accomplished with both fixation devices     and bone surfaces. On the other hand, more complex fractures with continuity defects or     comminuted need to be handle using rigid fixation where the device assumes all the forces     (load-bearing principle). These approaches are well established, whereas the level of     evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In     fact, which surgical treatment, or combination of treatments, leads to the best outcome and     the lowest rate of complications in bilateral DMFs is an open question.      The purpose of this study is to assess the complication rate in patients suffering from     bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination     of rigid fixation on one side and non-rigid fixation on the other side.   "
72144|NCT02341430|"     This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh     option in the repair of grade I and II ventral hernias.   "
72145|NCT02341417|"     This is a phase 3, 32-week, multicenter, single arm, open-label extension study. All enrolled     subjects will be administered cinacalcet daily during the treatment period in addition to     standard of care treatment which can include therapy with Vitamin D sterols, calcium     supplementation, and phosphate binders.   "
72146|NCT02341404|"     The primary aim of the study was to characterize and quantify the histopathological changes     in the surgical specimens obtained in patients undergoing prostatectomy in addition to     imaging changes (MRI) following a single injection of Liproca Depot in patients with     localized prostate cancer.   "
72147|NCT02341391|"     The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene     therapy product that uses allogenic human chondrocytes expressing Transforming Growth     Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and     severity of the adverse events, the physical examination findings, and the laboratory test     results after the intra-articular injection of TissueGene-C.      And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion,     functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the     injection site.   "
72148|NCT02341378|"     To assess the efficacy and safety of the intra-articular injection of TissueGene-C in     patients with degenerative arthritis of the knee   "
72152|NCT02341326|"     Early changes associated with the development of smoking-induced diseases, e.g., COPD and     lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal     airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells     necessary for generation of differentiated airway epithelium. Based on our preliminary     observations on SAE BC cells and FGFR2 signaling, we hypothesized that suppression of FGFR2     signaling in the SAE BC stem/progenitor cells by cigarette smoking renders these cells less     potent in generating and maintaining normally differentiated SAE, shifting these cells     towards a COPD associated phenotype. To test this, SAE basal cells will be isolated from     cultured cells obtained through bronchoscopic brushings and analyzed through in vitro assays     for their stem/progenitor capacities.   "
72153|NCT02341313|"     Low blood sugar levels are common in babies after birth. This may be normal as babies can use     other sources of energy. However if a baby does not produce these fuels the brain can be     starved of energy and be damaged. Measurement of these fuels is not done as part of clinical     practice in the newborn. We aim to see whether at the same time as taking the blood sugar     level from a heel prick we can measure these fuels in a small drop of blood. At the same time     as blood needs to be taken for clinical reasons we want to take a drop of blood from 50     babies to see how good the point of care (POC) meters are compared to the laboratory at     measuring these fuels. If accurate these POC meters could identifying those at risk from     brain damage as well as prevent separation of mothers and babies who are establishing breast     feeding.   "
72179|NCT02340975|"     This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to     evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and     immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or     tremelimumab monotherapy in subjects with metastatic or recurrent gastric or gastroesophageal     junction adenocarcinoma   "
72180|NCT02340962|"     A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy     and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve     East Asian Subjects with Chronic Hepatitis C Virus Genotype 1b Infection.   "
72154|NCT02341300|"     Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the     first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of     anemia are variable and depend largely on preexisting iron stores and supplementation.     Estimates from the World Health Organization report that 35% to 75% of pregnant women in     developing countries and 18% of women from industrialized countries are anemic. Maternal     anemia is associated with an increased risk of preterm birth, low birthweight, and small for     gestational age infants. Many studies have shown improvement in these outcomes with maternal     iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates     that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the     first year of life.      Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that     anemic pregnant women are at greater risk of death during the perinatal period and that     anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal     deaths per year.      The need for iron averages close to 1000mg in a typical singleton gestation. This amount     considerably exceeds the iron stores of most women and will result in iron-deficiency anemia     unless supplemental iron is taken. One problem with iron supplement use is compliance,     secondary to adverse effects such as constipation and nausea. Research on the use of cast     iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has     been promising. These studies have demonstrated good compliance with no reported adverse     effects. The aim of our study is to determine if providing anemic women in the first     trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in     pregnancy.      Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.   "
72155|NCT02341287|"     The investigators plan to test the effectiveness of warm gel gloves in reducing the time it     takes individuals to fall asleep (sleep latency). The investigators will have subjects track     their sleep for two-weeks using both sleep logs and a small wristwatch-like monitor called an     actigraph to measure the degree of the persons' difficulty falling asleep. It must take at     least 30-minutes to fall asleep 3-days per week to qualify for the study. If a subject     qualifies, they will wear the heated gel gloves or a placebo non-heated gel glove during     sleep for two-weeks and sleep will be measured again using sleep logs and actigraphy. The     baseline sleep latency data will be compared to the treatment period using a independent     t-test. The investigators believe that wearing the warm gel gloves will reduce sleep latency.   "
72156|NCT02341274|"     Amorphous solid dispersion (ASD) formulations are increasingly used by the pharmaceutical     industry to develop poorly water-soluble drugs into effective oral dosage forms. Examples     include the antifungal drug itraconazole, the HIV protease inhibitor combination,     lopinavir/ritonavir and the immunosuppressive, tacrolimus. There is potential for significant     variation in bioavailability of ASD and thus heightened concern regarding the therapeutic     efficacy as generic versions of these poorly water-soluble compounds become approved. The     variation in bioavailability is to be expected because of our limited understanding of the     precise physical chemistry of drug polymer amorphous solid dispersion formulations.   "
72157|NCT02341261|"     The proposed study will randomize participants with diabetic peripheral neuropathy into two     groups. One group of participants will receive standard-of-care counseling while the other     group will undergo supervised exercise and counseling to increase physical activity.   "
72158|NCT02341248|"     Exclusive Enteral Nutrition (EEN) is the liquid diet given to children with active Crohn's     Disease (CD). EEN has previously been shown to induce changes in major bacterial metabolites     and dominant bacterial species which are more profound in children that clinically improve.     This study aims to determine whether it is possible to maintain these bacterial changes with     prolonged supplementary enteral nutrition (SEN) while returning to normal diet and if this     can reduce risk of subsequent relapse for children with CD.      New technologies will allow measurement of a broad range of bacteria and metabolites, to test     if the clinical response to EEN and changes in gut inflammation are associated with bacterial     composition and chemical products; and if maintenance of changes using SEN reduces the risk     of relapse over a 12 month period.      The study will aim to recruit all potential Crohn's disease children coming to a tertiary     paediatric centre for colonoscopy. Once consented, an initial blood, urine and faecal sample     will be requested along with 8 mucosal biopsies during the routine endoscopy session. If     diagnosed with CD, and if the clinician prescribes treatment with EEN, an additional blood     sample will be requested at the end of EEN, and 5 faecal and urine samples spread over 12     months; as well as some dietary information.      Samples will be collected from up to 42 children with CD and 42 age- and sex-matched healthy     volunteers. Initial samples taken from children who were not diagnosed with CD will be     compared with CD samples to look for potential metabolic disease markers. Characterisation of     faecal bacteria and metabolites in both faeces and urine; as well as measurement of blood     inflammatory biomarkers will be performed.   "
72159|NCT02341235|"     The purpose of this study is to compare an enhanced intervention that includes narrative and     game components to a standard intervention that only targets self-monitoring. These     approaches will be tested among postmenopausal breast cancer survivors who are sedentary and     overweight.   "
72160|NCT02341222|"     The Buckypaper (BP) is an innovative material that has attracted the attention of many     research groups engaged in the study of its possible applications in various technological     fields. Our purpose is demonstrate the viability of the application of nanotechnologies to     the General Surgery in human with thwe use of a new self standing prosthetic device for the     reconstruction of abdominal wall defects.   "
72162|NCT02341196|"     This study examines the risk of thrombogenicity of the carotid patches in polyurethane     compared to carotid patches in polyester including death, any stroke, carotid thrombosis at     30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.      This study was run at the University of Roma, La Sapienza and at the University of Poitiers,     randomisation was done in both enters after approval by the Ethical committee of the     University of Roma (Record uploaded)   "
72163|NCT02341183|"     The primary objective of this study is to assess tolerability and effect of HS (hypertonic     saline) delivered with the tPAD (transnasal Pulmonary Aerosol Delivery) device on mucociliary     clearance (MCC) in chronic obstructive pulmonary disease/chronic bronchitis (COPD/CB)     subjects. The investigators hypothesize that HS delivery via tPAD will be safe and and while,     and will improve MCC.   "
72164|NCT02341170|"     The primary aim of this study is evaluate the impact of hippocampal-sparing prophylactic     cranial irradiation (HS-PCI) on survival status in patients with nodal-positive (locally     advanced) adenocarcinoma by comparing overall survival rates of patients undergoing HS-PCI to     that of patients without this intervention. In addition, this study aims to investigate     whether HS-PCI is detrimental on neurocognitive function and to evaluate its impact on the     patient's quality of life.   "
72165|NCT02341157|"     This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to     the current disease management COPD discharge protocol subsequent to an admission for COPD     exacerbation.   "
72166|NCT02341144|"     This is a prospective, double-blinded, randomized controlled study comparing the efficacy of     pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under     direct visualization prior to closure of the incision for providing post-operative analgesia     following umbilical hernia repair in children. The current management for reducible umbilical     hernias is umbilical hernia repair under general anesthesia as an outpatient procedure.      Patients aged 3-18 years old with a diagnosis of umbilical hernia will be screened for study     inclusion. Eligible patients and their parents/guardians will be approached and, if     agreeable, consented for the study pre-operatively. Patients will be randomized to receive     either pre-incisional percutaneous rectus sheath block by the anesthesiologist or     intra-operative rectus sheath block under direct visualization prior to closure of the skin     incision by the surgeon. The patient, patient guardians, select research team members, and     post-anesthesia care unit (PACU) staff will be blinded to the method of analgesic     administration.   "
72167|NCT02341131|"     The main objective of the study is to analyse the role of a neurotrophic factor (BDNF) as a     putative biological marker of the cognitive recovery in schizophrenia following a Cognitive     Remediation Therapy (CRT). Additionally, the role as outcome predictors of BDNF serum levels     and the Val66met polymorphism and data from functional and structural neuroimaging will be     studied.   "
72168|NCT02341118|"     BRCA1 or BRCA2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22%     germline BRCA1/2 mutation frequency in patients with high grade serous histology subtype,     including those women who have no family history of breast or ovarian cancer. With the rapid     advancement of therapeutics targeted this population, this protocol seeks to provide genetic     BRCA1/2 screening to all patients with high grade serous ovarian cancer. This information may     help in selection of future treatment options and genetic testing for BRCA1/2 may be used to     potentially prevent a proportion of cancer for the family members.      This study will be an opportunity for patient to improve access at genetic and molecular     testing for BRCA1/2 mutation which could impact her future treatment option. Moreover, this     study will allow to prospectively assess the proportion of patients with BRCA mutation in     ovarian cancer and describe the type of mutations identified in a large population.   "
72169|NCT02341105|"     Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older     patients with persistent atrial fibrillation (AF).      Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years     with symptomatic AF for the composite outcome of hospitalization for cardiovascular cause or     emergency department visit for atrial arrhythmia   "
72170|NCT02341092|"     Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the     close friends of people victims of traumatic brain injury.   "
72171|NCT02341079|"     The purpose of the study is to evaluate the efficacy of local infiltration of liposomal     bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early     postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate     equivalency of treatment modalities to provide an alternative to the commonly used treatment     of femoral nerve blockade.   "
72172|NCT02341066|"     To evaluate the contribution of the assessment of endothelial dysfunction (ED) in improving     coronary hearth disease (CHD) risk stratification obtained by the Framingham risk score (FRS)     in rheumatoid arthritis population (RA).   "
72173|NCT02341053|"     Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA)     are at significant risk for poor bone health as defined by low bone mineral density (BMD) and     increased propensity to fracture. Poor bone health is thought to be related, at least in     part, to abnormally low levels of load experienced by the skeleton. A common physical     approach for increasing bone density is to stimulate the musculoskeletal system by increasing     the amount and duration of weight-bearing in the lower extremities. For non-ambulatory     individuals, this takes the form of using an assisted standing device to enable the child to     spend time in a standing position with some degree of weight placed on the lower limbs. Some     of these physical interventions demonstrate variable improvement in BMD in children with     neuromuscular conditions, and some do not. A serious limitation in the previous work in this     area is a failure to objectively measure the magnitude and duration of the loading     experienced by the lower extremities. Thus, a lack of change in BMD may be due to the     extremities experiencing only a fraction of the body weight (due to load-sharing with the     assistive device) for an inadequate duration of standing time.      In order to investigate the efficacy of standing treatment for increasing BMD, the     investigators will develop a simple, portable and inexpensive transducer that will measure     the magnitude and time course of the load experienced by the lower extremities of individuals     with SMA who use a stationary assisted standing device. The specific goal of this proposed     project will be to develop, validate and establish the initial feasibility of such a     measurement device.   "
72174|NCT02341040|"     The goal of the study is to determine accurate blood test levels that can predict whether or     not subjects are truly allergic to certain foods. In this study, subjects that are clinically     documented to be wheat-allergic will participate in a double blind oral food challenge. Blood     will be collected from the subject to evaluate the potential allergenicity of proteins     introduced into genetically modified crops and evaluate wheat-specific IgE antibody     reactivity to biotech and conventional wheat varieties.   "
72175|NCT02341027|"     This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG)     contraceptive implant within 5 days of delivery improves implant utilization at 6 months     postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.   "
72176|NCT02341014|"     This is an open label phase Ib/IIa study of patients with relapsed/refractory B- and T-cell     lymphomas who are treated with carfilzomib, lenalidomide and romidepsin in a 3+3 design. The     phase IIa portion of the study will involve a dose expansion at the MTD to better     characterize the efficacy and to inform further disease specific studies.   "
72177|NCT02341001|"     The purpose of this study is to determine whether text message support after discharge from a     bariatric service improves outcomes following bariatric surgery.   "
72178|NCT02340988|"     The purpose of this study is to assess the drug interaction potential and time course of the     effect of oritavancin on warfarin pharmacokinetics in an open label, single arm manner.   "
72186|NCT02340884|"     Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress     Management (PRISM) Intervention for Adolescents and Young Adults with Cancer      Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients     with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those     ages 13-17 (N=50); (2) those ages 18-25 (N=50).      Study Design: Pilot randomized controlled trial (RCT).      Primary Objective: To test the efficacy of the Promoting Resilience in Stress Management     (PRISM) among Adolescents and Young Adults with cancer.      Primary Outcome: Change in patient-reported resilience (based on score of standardized     Connor-Davidson Resilience Scale) at 6 months.      Secondary Outcomes:        1. Patient-reported resilience at 2, 4, and 12 months        2. Patient-reported self-efficacy, benefit-finding, psychological distress, quality of          life, and health-behaviors at 6 and 12 months.        3. Qualitative assessment of patient-reported goals at 6 and 12 months        4. Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial          outcomes      Study Duration: 3 years   "
72187|NCT02340871|"     In Israel, because of special qualification in neurogenetics, during a 30 year career ,we     have found, characterized and treated at least 13 novel neurological diseases. The genetic     basis was elucidated with geneticist colleagues both in Israel and worldwide. The diseases we     have found encompass all the fields of pediatric neurology including intellectual disability,     epilepsy, muscle-nerve disorders, malformations of the brain, microcephaly, macrocephaly,     cerebellar ataxia, chorea. dystonia, cerebral palsy and many other symptoms and signs.      We are especially interested in consanguineous families, in whom the parents are first or     second degree cousins. These families often bear autosomal - recessive diseases. If the     family is informative - with 2 or more affected children - then with current genetic     techniques there is a good chance of finding the causative gene to this specific disease.     This is not only a theoretical - academic accomplishment. In practice, after discovering the     gene, the family is given genetic counseling and in their further pregnancies the geneticists     will examine either by preimplantation genetic diagnosis (PGD) or amniocentesis if the embryo     is affected or not. In the early stages of the pregnancy if the embryo is indeed affected by     the disease caused by the gene we have found and the religious official consents, genetic     counseling can offer termination of pregnancy to the couple.      Needless to say, we know the immense burden of an affected child on the family, community and     society. The parents are guilt-ridden, the affected child draws extensive resources from     educational, health and rehabilitation authorities. We can contribute to the well-being of     the family and the clan (because many times the relatives are affected).      We can perform sophisticated genetic studies such as Whole Genome Sequencing and Whole Exome     Sequencing.After an informative family is recruited to the study, we will explain the aims of     the research. The parents and eligible patients will sign informed consent forms, according     to the local Helsinki Board. Blood samples will be taken in Israel, DNA extracted in the     Israeli lab and then shipped coded to the researchers in USA or Germany. If the researchers     will find a new gene the family will be notified and given appropriate genetic counseling. We     will continue to follow and treat the family onwards.   "
72188|NCT02340858|"     This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating     patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore     on the cell membrane and inducing target cell death.This may be an effective treatment for     patients with unresectable breast cancer.   "
73251|NCT02326961|"     The primary objective of this study is to evaluate the safety and feasibility of     intraarticular injection of Celution prepared adipose-derived regenerative cells injected     into knees of patients with chronic knee pain due to osteoarthritis.   "
72189|NCT02340845|"     The Phase II randomized, two-armed clinical study will investigate the efficacy of high dose     versus low dose Bromelain (Comosain) in human subjects diagnosed with advanced late stage     cancers. The study subjects will be randomly assigned to each group by a coin toss. Bromelain     (Comosain) extract, derived from the stem and fruit of Ananas Comosus will be administered     orally each day.   "
72190|NCT02340819|"     The purpose of this study is to evaluate the safety and efficacy of an investigational     treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look     at how teduglutide moves through the body (pharmacokinetics).   "
72191|NCT02340806|"     Administration of anesthetic solution into the epidural space is usually accomplished by a     combination of continuous infusion, provider-administered boluses and patient-administered     boluses (patient controlled epidural analgesia [PCEA]). The optimal method for maintaining     labor analgesia is unknown. Several studies have demonstrated that timed-intermittent     boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior     maintenance of labor analgesia than maintenance with a continuous infusion with PCEA.     Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA     recently became commercially available. Several infusion rates are available for delivering     the timed bolus, and the optimal bolus rate is unknown.   "
72192|NCT02340793|"     National guidelines recommend 15-20% weight loss for severe and complicated obesity. Weight     loss maintenance can be achieved in around 33% of patients at 12 months.      The BEYOND study will administer Counterweight Plus; a nutritionally replete Total Diet     Replacement Plan (TDR) of 800+ Calories followed by structured Food Reintroduction, and     Weight Loss Maintenance programmes.      The study will incorporate three work packages with the aim of:        1. examining changes in body composition with substantial (target >15kg) non-surgical          weight loss (work package 1, WP1)        2. characterizing the metabolic adaptations during weight loss and maintenance (work          package 2, WP2)        3. examining Rescue Packages as a method of weight re-gain prevention (work package 3,          WP3).   "
72193|NCT02340780|"     The purpose of this study is to find out what effects a new drug, buparlisib, has on chronic     lymphocytic leukemia.   "
72194|NCT02340767|"     The study will determine whether dentists who use a diagnostic device treat suspicious     occlusal carious lesions (SOCL) surgically more often, with the same frequency, or less     frequently, than dentists not relying on a diagnostic device. The study will also determine     -- among those SOCLs that are opened -- whether the proportion of lesions that extend into     the dentin when dentists are using a diagnostic device is more than, the same, or less than     when no device is used.   "
72195|NCT02340754|"     The primary purpose of this study is to assess the feasibility of mindfulness-based stress     reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives are     to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared     to an education control group; and 2) Explore the durability of the effects of MBSR over one     year.   "
72196|NCT02340741|"     Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in     the early postoperative period after open cardiac surgery.   "
72652|NCT02334787|"     To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or     3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a     multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.   "
72197|NCT02340728|"     The purpose of this study is to compare the effects good and/or bad of combining     radiofrequency ablation with placement of a second stent, versus a second stent alone. The     investigators will also look at the safety of the combination treatment, and see which     treatment is better. In either case, the second stent will be placed inside the existing     stent as is done in standard practice when treating a blocked stent for the first time.   "
72198|NCT02340715|"     The purpose of this study is to determine if it would be helpful to use advanced MRI imaging     techniques to take additional views of the tumor target for radiation treatment planning or     treatment follow-up MRI.   "
72199|NCT02340702|"     The presence of chronic obstructive pulmonary disease (COPD) would confer increased     in-hospital mortality and length of hospital stay in patients with acute decompensated heart     failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute     decompensated heart failure and (2) the association between COPD and in-hospital mortality or     length of stay in this cohort.   "
72200|NCT02340689|"     Specific mutations relating to hyperoxaluria will be determined via DNA analysis by the Mayo     RKSC research staff.   "
72201|NCT02340676|"     This research study is evaluating a combination of a therapy called Extra-corporeal     Photopheresis (ECP) with a drug called Interleukin-2 (IL-2) as a possible treatment for     chronic graft-versus-host-disease (GVHD) following allogeneic stem cell transplant.   "
72202|NCT02340663|"     Clinical trials of bite splint use and night time tooth grinding have not been performed.     Consequently, there are no definitive outcome measures or efficacy standards that can be     applied to large clinical trials. The present preliminary trial will determine what objective     measures can be used to evaluate efficacy. The outcome variables will fall into four     categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user     satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard,     (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic     'bite splint' or 'orthotic', hereafter called the Michigan bite splint, to compare the     performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the     outcome variables identified in this study for broader clinical trials.      Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in     clinical laboratory conditions. Hypothesis: There will be no significant differences between     the devices in terms of fabrication efficacy, functional efficacy or user satisfaction.      Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint     under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be     no significant differences between the devices in terms of compliance or functional efficacy.   "
72215|NCT02340494|"     This project proposes to develop and test an internet resource - a supported self-management     website - that will guide younger women to relevant knowledge and resources, and provide     tools that will help YWBC become more skilled and confident in coping with the many     challenges of breast cancer. The study will be conducted in collaboration with the newly     funded, pan-Canadian Young Breast Cancer Cohort (CYBCC) program being led from Women's     College Hospital. The resource is expected to reduce knowledge gaps experienced by YWBC, and     help them be partners in decision-making about their care, which has been shown to reduce     anxiety and depression years later.   "
72203|NCT02340650|"     This is a pilot study involving 100 subjects. The primary aim will be to conduct image     analysis with the use of High resolution micro-endoscope on the profile of normal bladder     tissue, inflamed bladder tissue, suspicious bladder tissue and bladder cancer tissues . The     secondary aim will be to examine the effectiveness of the new (HRME) device for early     diagnosis of bladder cancer with less invasive procedure. This is a pilot study examining     imaging analysis in patients with normal bladder tissue, inflamed bladder tissue, suspicious     bladder tissue, and bladder cancer who are scheduled to have cystoscopy.      This is a cross sectional study therefore, each patient will participate only once in this     study. The study involves only 1 visit: Visit #1: schedules cystoscopy and biopsy procedure     that are part of standard care and then capturing image with the use of HRME device as a part     of research procedure.      All the procedures performed in this study are normally done in the work-up of patients     scheduled to have cystoscopy procedure and is considered a routine procedure for bladder     cancer screening. The only procedure/treatment which is not routine is the use of High     resolution microendoscope. Biopsy will be taken at the time of cystoscopy that involves     standard of care. Images taken by HRME device will then be correlated with pathology results     of the biopsied tissue. The samples will be coded and de-identified data will be sent to Dr.     Kortum's laboratory for correlation.      The blood and urine samples collected during the screening visit are routine tests for     patients with bladder cancer and will be handled according to standard of practice. The test     results will be included in the subject's research and medical charts. Additional research     related information will be provided at the end of the study.      Risks include those related to cystoscopy and HRME device may include infection, pain,     difficulty with urination and blood in urine, perforation.      Potential benefits may include to this subject class for early detection of bladder cancer     with minimal invasive technique.      Understanding the effects of HRME device on the bladder screening may improve screening and     detection methodologies for future patients with bladder cancer.   "
72204|NCT02340637|"     The purpose of this study is to provide knowledge regarding the effect of early intervention     and prevention on the development of anxiety and depression in children. The focus of the     intervention is to reduce symptoms of anxiety and depression and help children develop skills     to enhance self-esteem in order to improve life quality. Gender and ethnicity will be studied     as moderating factors. Primary care givers will be trained in the use of evidence based     methods for children with internalizing difficulties. Children in need will be identified and     receive improved services, based on international standards. Active collaboration will be     established nationally between three Centers for child and adolescent mental health     (RKBU/RBUP) and internationally with Philip C. Kendall at the Temple University in     Philadelphia and Kevin Stark at University of Texas at Austin.      Primary aims are to examine if an indicated group and school based program, Coping Kids, is     more effective than treatment as usual (TAU) in reducing high levels of symptoms of both     anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable     over 12 months.   "
72244|NCT02340117|"     This clinical trial is an open label Phase II study of the combination of intravenously     administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic     cancer as a first-line treatment. The objective of the study is to evaluate the safety,     tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month     (PFS5.5mos)) of this combination therapy.   "
72245|NCT02340104|"     The purpose of this study is to compare how much baricitinib (study drug) gets into the blood     stream when it is given as a single dose (in tablet form) and as an intravenous infusion     (injection given directly into a vein via a small needle). Each participant in the study will     make four visits to the investigator site over the course of about 6 weeks.   "
72246|NCT02340091|"     The objective of this study was to evaluate the efficacy and safety of HA IDF plus (with     lidocaine) injected in the nasolabial fold compared to HA IDF (without lidocaine).   "
72205|NCT02340624|"     Tobacco smoking in pregnancy remains one of the most important and preventable cause of     adverse pregnancy outcomes. Data from National Survey of Drug Use and Health (NSDUH)     suggests, that the annual average rates of current cigarette use among women aged 15 to 44     who were not pregnant decreased from 30.7 percent in 2002-2003 to 24.0 percent in 2012-2013.     However, the prevalence of cigarette use among pregnant women in this age range did not     change significantly during the same time period (18.0 percent in 2002-2003 and 15.4 percent     in 2012-2013)Smoking cigarettes during pregnancy and nursing causes considerable health     damage to the fetus and to the infant during the initial growth phase. An estimated 19.8     million women in the United States smoke. Nationally, 23 percent of women report smoking in     the 3 months before pregnancy, while 13 percent report smoking in the last 3 months of     pregnancy. Overwhelming evidence suggests that maternal smoking during pregnancy is     associated with an adverse pregnancy outcomes including IUGR, placenta previa, abruption     placentae, preterm premature rupture of membranes, low birth weight, perinatal mortality,     intrapartum stillbirth and ectopic pregnancy. Moreover, prenatal exposure to tobacco smoke     also increases risk of attention deficit and hyperactivity disorder (ADHD) and sudden infant     death syndrome (SIDS) in the offspring.Children born to mothers who smoke during pregnancy     are at increased risk of asthma, infantile colic, and childhood obesity.      Brief interventions are shown to be associated with small but clear increases in smoking     cessation in pregnancy, but are rarely used. Technology may fill this void. For the present     study, pregnant women reporting smoking during pregnancy will be recruited and randomly     assigned to one of eight combinations of three technology-delivered intervention approaches:     Brief intervention, Quitline referral, and SmokeFreeMoms text messages     (http://women.smokefree.gov/smokefreemom.aspx).   "
72206|NCT02340611|"     This is a phase 2 study (the second phase in testing a new drug or drug combination) to see     how useful adding investigational drug cediranib to olaparib after disease progression on     olaparib alone in patients with ovarian cancer.   "
72207|NCT02340598|"     Randomized trial of supplying a cold vest as compared with controls (no cold vest) on     cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and     also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to being     given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as     the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. The     remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are     checked at baseline, after 2 months and after 1 year.   "
72208|NCT02340585|"     The primary objective of this study is to demonstrate effectiveness and safety of the     Neuroform Atlas Stent System for use with bare metal embolic coils.   "
72209|NCT02340572|"     Anticalins® are engineered human proteins that are able to bind specific target molecules.     The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin     and is intended for treatment of anemia of chronic disease. This phase I First-in-Human study     shall investigate safety and pharmacokinetics in healthy human volunteers.   "
72210|NCT02340559|"     The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in     people with a brief psychotic disorder, especially positive symptoms.      The secondary objectives would be to assess the effect of EMC on metacognition (cognitive     distortions and deficits in theory of mind), psychosocial functioning and quality of life,     neuropsychological functioning and gender, as well as determine the changes produced by EMC     in the insight of each session and the maintenance of the effects of EMC program at six     months of treatment.   "
72211|NCT02340546|"     In chronic systolic heart failure patients submitted to cardiac resynchronization therapy,     the study aims at assessing whether geometric variations in coronary sinus lead tip     trajectory throughout the cardiac cycle acutely induced by biventricular pacing, are     predictive of the volumetric and clinical response to the treatment at six-month follow-up.   "
72212|NCT02340533|"     The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy     for diagnosing adenomyosis.   "
72213|NCT02340520|"     This is a pilot study designed to evaluate the effects of theophylline and roflumilast on     circulating Histone deacetylase (HDAC) levels in subjects with COPD, and the bronchodilator     effects of corticosteroids. Studies will be performed in 10 subjects with COPD nonresponsive     to bronchodilators. Subjects will receive theophylline tablets for 1 week, followed by     measurement of circulating HDAC and the acute effect of oral prednisone on the bronchodilator     response to inhaled beta agonist. Roflumilast tablets will be added to the theophylline for a     further week and the studies repeated. The study will provide preliminary data on the effects     of theophylline and roflumilast on circulating HDAC levels and the effects of corticosteroids     on the beta agonist bronchodilator response in COPD.   "
72217|NCT02340468|"     In the field of cancer treatment, it is generally accepted that the enhancement of oxygen     delivery to tumors can augment the effect of anti-cancer therapies. In the case of     chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment     reaching the tumor and having an effect.   "
72218|NCT02340455|"     Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA,     an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting     hyperalgesia. If the GABA level can be maintained at certain level, the progression into     hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative     opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the     effective postoperative pain management and the prevention of hyperalgesia from pregabalin,     GABA analogue, and the possible sex difference in such effects of pregabalin.   "
72219|NCT02340442|"     Maternal obesity, overweight and hypertensive disorders are among the most important risk     factors for complications during pregnancy. Several lines of evidence indicate that     overweight or obese women, as well as women with hypertensive disorders show increased risks     of preterm birth before 32 weeks. However, an easy to determine, common reliable prognostic     factor which allows for the early identifications of risk patients is still lacking.     Recently, it has been reported that assessment of endothelial function may be a new promising     tool for predicting the risk of adverse pregnancy outcome. As such evidence has been provided     that endothelial dysfunction is prevalent among women with preeclampsia and is able to     identify women at increased risk of preterm delivery and small-for-gestational-age (SGA)     births. Several lines of evidence indicate that functional and structural changes of retinal     vessels are altered in vascular related disease and may predict cardio-vascular events.     Consequently, the current study seeks to investigate whether flicker induced vasodilatation,     a well established parameter to test vascular function in-vivo is altered in women with low     and high risk pregnancies when compared to a healthy control group. The data gained from this     study may provide the basis for a larger longitudinal trial to assess whether vascular     changes in the retina may predict the risk for complication during pregnancy.   "
72220|NCT02340429|"     Medical care today is moving towards patient centered care (PC) and patient empowerment (PE),     both in practice and in medical staff training . Applying this methodology enhances patient     autonomy in the clinical setting and allows shared decision making.      Current mobile and video technology enables the caregiver(clinician) to share visual data     with the patient, making him or her a more active participant in the medical procedure. It     has been shown that higher patient satisfaction rate regarding the patient/physician     encounter, has a positive effect on medical procedure outcome and patient compliance.      Patient centered care and Patient Empowerment benefits are maximized using the proper tools.     One such tool is the video otoscope. In this study we apply the PC/PE approach of medical     care and introduce video otoscopy in the setting of a pediatric emergency room. We use an     affordable (~300$), FDA approved, High Res. video otoscope. (DE500 Digital Video     Otoscope,Firefly global Inc.) Patients will be randomized upon admission into two groups:     video otoscopy and standard otoscopy. Upon discharge from the pediatric ER, parents will be     asked to answer a short questionnaire regarding their satisfaction with the ER visit and the     otoscopic examination.      We aim to study the impact of affordable, high res. video otoscopy, on the general     satisfaction of parents from their emergency room experience, vs their experience when     undergoing a regular otoscopic examination.      Inclusion criteria: children under 18y admitted to the pediatric ER for any reason,     undergoing routine otoscopy, who's parents have signed an informed consent.      Exclusion criteria: no parental informed consent,lake of compliance or inability to perform     otoscopy.      Number of participants: 60 (30 in each group) Study start: January 2015 Study ends:January     2016 Study location: Ziv medical center, Zefat Israel   "
72221|NCT02340416|"     Cerebral microemboli (ME) are frequently generated during major orthopaedic surgery. The     primary objective of this study was applying novel transcranial Doppler (TCD) ultrasound     software algorithm to quantify (ME load/15 minutes) and qualify (particulate vs. gaseous) ME,     detected as high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs)     before and after orthopaedic surgery.   "
72222|NCT02340403|"     Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling     neuropathic pain that can last for months or even years after the end of chemotherapy.     Currently, there is no effective neuroprotective treatment to prevent or relieve this pain.     The only strategy is the reduction of oxaliplatin doses or premature discontinuation of     therapy, with the risk of burdening the prognosis for remission. Thus, a better understanding     of the pathophysiology of these iatrogenic neuropathies appears necessary in order to     discover new potential therapeutic targets.      Preclinical works were able to demonstrate important metabolic changes in certain brain     structures in an animal model of oxaliplatin-induced neuropathy. A significant increase of     choline concentration has been found in the posterior insular cortex of neuropathic animals     compared with control animals. Furthermore, the concentrations of choline were positively     correlated to nociceptive thresholds. Thus, neuropathic pain induced by oxaliplatin would     involve the posterior insular cortex and would be associated with an increase in choline     concentration at this level. Clinical translation of these preclinical results is feasible in     practice since choline concentration can be determined in the brain by non-invasive magnetic     resonance spectroscopy.   "
72223|NCT02340390|"     Evaluate the safety and effectiveness of patients who received G7 Acetabular system in     conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem     compared to patients who received the Exceed ABT Acetabular system with the same combination   "
72224|NCT02340377|"     The primary objective of the proposed study is to determine the use of a wireless method to     monitor and record core body temperature during a Whole Body Hyperthermia treatment, compared     to an indwelling rectal thermometer.      This protocol is intended to study the differences between a rectal temperature probe and an     approved wireless and indigestible thermometer during a WBH session. The current standard in     monitoring core body temperature is the usage of an indwelling rectal thermometer. Many     patients and potential study subjects, however, decline receiving the treatment, due to the     discomfort of using this measuring method and a wireless measuring device would open the     possibility for those patients to receive a treatment. The primary endpoint for example of a     treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C. However,     due to the proximity of the probe to the body's surface, the core body temperature will vary     from the rectal temperature and the comparison between the two methods with a validation of     the wireless device is necessary.      The investigators will monitor subject's physiological outcome from a single Whole Body     Hyperthermia treatment in an open fashion (no placebo/control condition). This study will     include safety assessments 7 days several days prior to or same day as the WBH, and include     follow-up assessments 1 day and 1 week later.   "
72225|NCT02340364|"     The investigators are asking subjects to take part in the Patient NAVIgation to Reduce     Readmissions among Black Men with Heart Failure (NAVI-HF) research study. This research study     will test how well trained laypeople working as patient navigators will help patients     recently hospitalized for heart failure avoid future hospitalizations. NAVI-HF is a new     program sponsored by funding from the National Institute of Minority Health and Health     Disparities. People who enter into the study will work with a patient navigator to undergo     the full program or work with a trained layperson to receive general education on heart     disease treatment and prevention. The purpose of the study is to determine whether a patient     navigation program will be effective in reducing the number of hospitalizations in the future     for program participants. This study will enroll 416 participants from UAB.   "
72226|NCT02340351|"     The purpose of this study is to determine whether auricular acupuncture (AA) according to the     NADA protocol and progressive muscle relaxation (PMR) differ in their effectiveness of     treating people with anxiety disorders or major depressive disorder. We hypothesized, that     both treatments show significant effects in alleviating the examined items (tension, anxiety,     anger/aggression and state ofr mood) and that there is no significant difference between     these two treatments.   "
72247|NCT02340078|"     The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with     lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).   "
72248|NCT02340065|"     The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible     additive contribution in the detection of important lesions, namely polyps and cancers,     compared to standard colonoscopy, in a series of patients undergoing back-to-back screening     or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible     changes regarding post-polypectomy surveillance programs following Endocuff utilization.   "
72249|NCT02340052|"     This is a prospective observational cohorte study. The aim is to investigate actual pain     treatment and outcomes in a large population of total hip arthroplasty patients at 5     different hospitals in Denmark.   "
72227|NCT02340338|"     Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from     the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible     for almost all of menstruation associated and more than 50% of all other cases. There is no     specific therapy.      The aim of this study is to demonstrate the safety and tolerability of the BioMed recombinant     toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The second aim of the     study is to measure antibodies in the blood of these healthy volunteers which have been     produced in response to treatment with the BioMed rTSST-1 Variant Vaccine. These antibodies     are expected to be important in resistance against the diseases. 46 healthy adults, male and     female, age 18-64 years will be assigned to 6 dose groups of the vaccine at the Department of     Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for     vital signs, hematology, clinical chemistry, blood cytokine level and antibodies against     TSST-1. Immunization will be repeated 4 weeks after the first with the same dose.   "
72228|NCT02340325|"     Background Scarring typically occurs after trauma, burn injury or surgery. Hypertrophic     scarring presents as raised, red and itchy lesions which variably respond to various     treatment modalities, such as corticosteroids, pressure garments, laser therapy, the use of     silicone sheets and radiotherapy.      Kynurenine, or Fibrostop 1 (FS1), and its further breakdown products, such as kynurenic     acid, or Fibrostop 2 (FS2), are endogenous products found in many systems and have shown     potential in reducing scar formation in animal studies.      The aim of study is to evaluate the safety and tolerability of FS2 cream applied to the skin     of healthy human subjects.   "
72229|NCT02340312|"     Recurrent abdominal pain has long been acknowledged to be the most common chronic pain     entities in children. The purpose of this study is to describe the microbiome in children     with FD and to explore relationships between the microbiome and postprandial distress     syndrome, anxiety scores, and mucosal biomarkers or anxiety. The specific goals of this study     are to: 1) Determine the frequencies and relative proportions for specific bacteria or     bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples. 2)     Determine if the frequencies or proportions of specific bacteria or bacteria phyla differ     between children with and without PDS. 3) Determine bi-variate correlations between     bacteria/phyla frequency, bacteria/phyla proportions, anxiety scores, and mucosal biomarkers,     respectively.   "
72230|NCT02340299|"     To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after     extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after     extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low     birth weight infants (VLBWs).   "
72231|NCT02340286|"     The purpose of this study is to determine energy expenditure and fat oxidation in 2 year old     children.   "
72232|NCT02340273|"     Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon     injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase     tendon strength, and improve quality of life for patients with tendon injury.   "
72233|NCT02340260|"     Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but     few patients exercise according to guidelines. In this study the effect of two time efficient     high intensity exercise protocols on glycemic control and other cardiometabolic risk factors     are investigated in patients with type 2 diabetes.The investigators assume that glycemic     control is improved more by low-volume high intensity interval training than by extremely     low-volume sprint interval training.   "
72234|NCT02340247|"     The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after     Roux-en-Y gastric bypass.   "
72235|NCT02340234|"     This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy     of lebrikizumab administered subcutaneously (SC) in adult participants with persistent     moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical     corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a     12-week blinded treatment period, and an 8-week safety follow-up period. Following screening     visit, eligible participants will enter in run-in period (Days − 14 to − 1) during which a     protocol-specified topical therapy regimen will be initiated. At the end of the run-in     period, participants who have: 1) demonstrated compliance with the protocol-specified TCS     regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.   "
72236|NCT02340221|"     This international, multicenter, randomized, double-blinded, placebo-controlled study is     designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo +     fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal     growth factor receptor-2 (HER2)-negative, oncogene that encodes for     phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally     advanced or metastatic breast cancer after recurrence or progression during or after an     aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm     versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant     tumors via central testing. The anticipated duration of the study is approximately 3.5 years.   "
72239|NCT02340182|"     The objective of this study is to investigate the role of the gut microbiota in the systemic     priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will be     treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven     days, in order to deplete the gut microbiota. Blood and faeces will be sampled before, 24     hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include     laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation     assay) and gut microbiota composition.   "
72240|NCT02340169|"     The objective of this study is to evaluate the potential of Topicort® (desoximetasone)     Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary     objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event     profile.   "
72241|NCT02340156|"     This Phase II clinical trial is an open label, single arm, multicenter study of the     combination of intravenously administered SGT-53 and oral temozolomide in patients with     confirmed glioblastoma who have proven tumor recurrence or progression. The objective of this     trial is to assess 6 month progression free survival (PFS), overall survival (OS), anti-tumor     activity, safety and possibly to evaluate, nanoparticle delivery to tumor site, and the     induction of apoptosis in the tumor..   "
72250|NCT02340039|"     Raised blood glucose levels can lead to adverse modifications to functional proteins within     the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may     help to control glycaemia following a carbohydrate meal or beverage. The aim of this study is     to investigate the effects of blackcurrant (BC) and apple (A) extracts on postprandial     glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a     mixed carbohydrate test meal.   "
72251|NCT02340026|"     The purpose of this study is to determine the optimal treatment duration of a novel early     mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of     treatment; and to evaluate the clinical futility of this intervention compared to current     rehabilitation practice.   "
72252|NCT02340013|"     This is a pilot study examining the feasibility of implementing a large randomized control     trial looking at the effect of endometrial shedding with medroxyprogesterone acetate compared     to no pre-treatment in women taking clomiphene citrate for ovulation induction for     infertility due to oligo-ovulation or anovulation.   "
72253|NCT02340000|"     The aim is to determine if high-dose amoxicillin/clavulanate is more effective than     standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at     a primary care office.   "
72254|NCT02339987|"     Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)   "
72255|NCT02339974|"     The goal of this study is to determine the short term safety (<30 days) and efficacy (6     months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena     cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or at     a very high surgical risk for tricuspid valve replacement.   "
72256|NCT02339961|"     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler     ultrasound system incorporating a special signal processing package- the Transthoracic     Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may     provide important insight into pulmonary blood vessels characteristics by the LDS (Lung     Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in     detecting PAH in SSc patients will be assessed in the study.   "
72257|NCT02339948|"     Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason     score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a     and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total     of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive     1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a     boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.   "
73252|NCT02326948|"     This case-control study matched by age and sex was performed to evaluate the region specific     risk factors for gallbladder cancer in Jeju island, Korea.   "
72258|NCT02339935|"     This study aims to implement and test a specific brief Applied Behavior Analysis model for     assessing and responding to severe challenging behavior during acute medical and behavioral     hospitalization for children with ASD. The investigators will evaluate the impact of this     program by conducting a randomized trial across both medical and psychiatric hospital     settings.   "
72259|NCT02339922|"     This phase II trial studies how well ixazomib citrate and rituximab work in treating patients     with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as rituximab, may block cancer growth in different ways by targeting certain     cells. Giving ixazomib citrate together with rituximab may work better in treating indolent     B-cell non-Hodgkin lymphoma.   "
72260|NCT02339909|"     This trial is a randomised controlled trial to assess whether annual attendance rates at     diabetic eye screening appointments in Kensington, Chelsea and Westminster could be improved     by offering invitees a small financial incentive. The research questions are:        1. Are incentives an effective strategy to encourage participation in the screening          programme?        2. Does the design of the financial incentive scheme affect its effectiveness in          influencing participation in health screening?        3. Does the choice of incentive scheme, if successful, attract patients who have a          different demographic or socioeconomic status to those who attend screening regularly?        4. Is offering these incentives a cost-effective strategy for enhancing participation?   "
72261|NCT02339896|"     To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New     Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies     intradermal regimen with or without Rabies Immunoglobulin in Children   "
72262|NCT02339883|"     Background:      - Magnetic resonance imaging (MRI) creates high-quality images of the human body without     x-rays. It uses a strong magnetic field and radio waves to take pictures. Researchers want to     test a scanner that uses a high magnetic field strength.      Objective:      - To study how the body responds to being in a high field 11.7T MRI scanner.      Eligibility:      - Healthy people ages 22 65.      Design:        -  Participants will be screened with a medical history and physical exam. They will          complete a healthy volunteer questionnaire and an MRI safety screening form. They may          have a 3T MRI scan of the brain.        -  Participants will have an MRI scan. They will lie on a table that will slide in and out          of the MRI cylinder very slowly. They will be asked to lie still.        -  Participants will do simple tasks while inside the machine. These can include listening          and responding to questions, tapping fingers, or moving a hand.        -  While in the scanner, participants will hear loud knocking noises. They will get          earmuffs.        -  Right when they exit the scanner, participants will get a questionnaire to fill out.          This will ask about how they felt inside the scanner.        -  During the MRI, participants heart rate, respiratory rate, and skin temperature will be          measured. Before and after the scan, these things plus blood pressure will be measured.        -  Participants will be tested before and after being in the MRI scanner. They will answer          questions, take pen-and-paper or computer tests, and do simple actions. Their sense of          smell may be tested.   "
72387|NCT02338245|"     This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical     activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination     with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on     prior trastuzumab therapy.   "
72263|NCT02339870|"     This randomized clinical trial studies expressive writing in improving the wellbeing or     comforting capacity of caregivers of patients with cancer. Expressive writing is a type of     intervention that asks people to write about important topics (in this case participants'     experience with their spouses'/partners' cancer) and their emotions/feelings surrounding     them. Expressive writing, including benefit finding and traumatic disclosure, may be a type     of at-home-therapy that caregivers can utilize in an attempt to increase their own wellbeing,     offer better comfort to cancer patients, and by association, help cancer patients cope with     and manage the cancer experience.   "
72264|NCT02339857|"     The purpose of this study was to investigate whether the no-touch saphenous vein grafts that     were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable     to the left internal thoracic artery when the vein grafts were anatomised to the left     anterior descending artery.   "
72265|NCT02339844|"     The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve     first-episode psychotic patients involving a standardized intervention with monotherapy with     aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined     after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive     tests, EEG, and PET-scannings.   "
72266|NCT02339831|"     The purpose of this study is to determine how well an active motion device, Camoped, works     compared to a continuous passive motion device, CPM, for rehabilitation after partial or     total knee replacement. It is hypothesized that the Camoped active motion device will provide     outcomes equal to or superior than the CPM. Patients undergoing either partial or total knee     replacement will be given the opportunity to participate. If they elect to participate,     preoperative data will be collected including demographics, measures of strength, balance and     knee bending, as well as surveys regarding current physical and mental health, as well as     knee function. After surgery, patients will be randomly selected to receive either the     Camoped or the CPM for use during their rehabilitation. After discharge, participants will be     asked to maintain a daily diary tracking their use of the assigned device, as well as their     daily pain levels. At a visit 4 weeks after surgery, participants will be asked to complete a     series of surveys pertaining to their health and knee function, as well as to perform tests     of strength, balance and knee bending. These results will be used to determine if one device     produces superior rehabilitation results following total or partial knee replacement surgery.   "
72267|NCT02339818|"     The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide     and Patient Alert Card in terms knowledge of the important identified risk of bleeding     associated with Eliquis treatment communicated by the RM tools.   "
72268|NCT02339805|"     This is a prospective descriptive monocentric study whose purpose is to describe the clonal     evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large     B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment   "
72269|NCT02339792|"     This randomized controlled pragmatic study is aimed to set-up, assess and implement an     integrated e-learning program of medical education in an hospital setting, focused on     teaching and implementing CGA added to geriatric pharmacological notions (GPNs) to improve     the quality of drug prescribing in elderly patients   "
72270|NCT02339779|"     This multicentre randomized controlled trial aims to evaluate a new breast reconstruction     technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to     receive a mastectomy (or having undergone mastectomy in the past) will be randomized to     undergo breast reconstruction with either AFT (intervention group) or reconstruction with     implants (control group). AFT will be evaluated in terms of quality of life, aesthetic     result, complications, oncological safety and cost-effectiveness.   "
72271|NCT02339766|"     Most women having planned cesarean section receive spinal anesthetic for the procedure.      Typically, spinal opioids are administered during the same time as a component of multimodal     analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal     opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and     occasionally respiratory depression.      The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve     branches and has an evolving role in postoperative analgesia for lower abdominal surgeries     and is a potential alternative to spinal opioids. There is some evidence that it may provide     visceral along with somatic pain relief. It is a simple and safe technique that has been     studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean     section.      If found effective, it will have the advantage of a reduction in opioid associated adverse     effects while providing similar quality of analgesia. This block has evolved from the     previously known transversus abdominis plane block.      We propose to undertake a study that will compare the relative efficacy of QL block with     local anesthetic to spinal morphine. We will also study if it provides any incremental     benefit when administered in addition to spinal morphine.   "
72272|NCT02339753|"     Carboplatin is widely used for conditioning regimens of autologous hematopoietic stem cell     transplantation for pediatric solid tumor, but the pharmacokinetics has not been evaluated in     pediatric stem cell transplantation before. As carboplatin have renal toxicity, the     pharmacokinetic study of carboplatin would help the safe and effective administration of     carboplatin for transplantation patients. Especially, the dose of carboplatin is higher at     conditioning chemotherapy, resulting in higher toxicity.      Carboplatin is a drug mostly excreted by kidney, and the dose of carboplatin is recommended     according to the body surface area and kidney function, represented by glomerular filtration     rate. After analyzing the pharmacokinetics of carboplatin, analyses will also be done for the     methods to determine the appropriate carboplatin dose.   "
72273|NCT02339740|"     This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly     diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia     involves high doses of a common class of chemotherapy drugs called anthracyclines, which are     known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth     of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may     stop the growth of cancer cells by either killing the cells, by stopping them from dividing,     or by stopping them from spreading. Completely removing or reducing the amount of     anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an     effective treatment for acute promyelocytic leukemia and may reduce some of the long-term     side effects.   "
72274|NCT02339727|"     It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are     important in neurodevelopment of term and preterm infants. This study tried to determine the     utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk     formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature     infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate     values of fatty acids they have in blood and psychomotor development they achieve.   "
72275|NCT02339714|"     A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had     significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or     no active treatment. The object of that study was to evaluate the effectiveness and safety of     acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the     only intervention for treatment group and sham acupuncture, no active treatment as its     control groups. Besides, acupuncture combined moxibustion showed better and longer effect     than acupuncture on allergic rhinitis patients in our previous pilot study. According to this     result, we are taking a pragmatic randomized controlled trial to further evaluate whether     acupuncture combined moxibustion is more effective than conventional treatment.   "
72276|NCT02339701|"     The primary goal of this phase II study is to comparing the SBRT and IMRT. The hypothesis for     each arm is that the probability of the change in EPIC HRQOL scores (1-year minus baseline)     is less than (or equal to) an acceptable limit. If it can be shown that either arm is     tolerable in terms of patient-reported outcome (PRO) then that hypofractionated regimen will     be considered for further use in a phase III study.   "
72277|NCT02339688|"     Current study will investigate the quality (psychometric properties) and clinical utility of     several mobility measures, according to disability level. Therefore, several aspects will be     inquired:        -  Was there an effect of rehabilitation        -  Is the measure able to detect change over time? And thus the change exceed measurement          error and is it clinically important (responsiveness)        -  Does the measure assess what it claims to measure (validity)        -  Is the measure able to differentiate all performances of the patients, inclusively the          very good and very bad performances (floor and ceiling effects)        -  Does the measure gives similar results under consistent test conditions on another          testing day (reliability) Worldwide, theoretical approaches to physical therapy and          rehabilitation in Multiple Sclerosis often appear significantly different. Since the          present research protocol will be performed at different centers across European          countries (and US sites), this multi-center study can additionally be applied for          mapping the volume and content of rehabilitation, as well as the differential impact of          diverse rehabilitation approaches and training volume on mobility, for several          disability levels.      Some health-economic analyses will be performed to examine what the approximate cost of     rehabilitation compared to effects is and what drivers of costs are (setting, equipment,     staff).   "
72290|NCT02339519|"     This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and     LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on     hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic     complications.   "
72278|NCT02339675|"     Current study will investigate de quality (psychometric properties) and clinical utility of     several measures of upper limb function, according to disability level. Therefore, several     aspects will be inquired:        -  Was there an effect of rehabilitation        -  Is the measure able to detect change over time? And thus the change exceed measurement          error and is it clinically important (responsiveness)        -  Does the measure assess what it claims to measure (validity)        -  Is the measure able to differentiate all performances of the patients, inclusively the          very good and very bad performances (floor and ceiling effects)        -  Does the measure gives similar results under consistent test conditions on another          testing day (reliability) Worldwide, theoretical approaches to physical therapy and          rehabilitation in Multiple Sclerosis often appear significantly different. Since the          present research protocol will be performed at different centers across European          countries (and US sites), this multi-center study can additionally be applied for          mapping the volume and content of rehabilitation, as well as the differential impact of          diverse rehabilitation approaches and training volume on mobility, for several          disability levels.      Some health-economic analyses will be performed to examine what the approximate cost of     rehabilitation compared to effects is and what drivers of costs are (setting, equipment,     staff).   "
72279|NCT02339662|"     The purpose of the study is comparing two drugs efficacy for the treatment of pain originates     from masticatory muscles. The two drugs are - Amitriptlyne (amitriptyline) and Gabapentin     (gabapentin), both of them are common use in for the treatment of chronic pain Methods -     patient that is diagnosed as suffering from myofacial pain, will receive one of the     medications above (Gabapentin or amitriptyline) for one month only, after which he will be     invited to pain clinic for control. Two weeks after that, the patient will start taking the     other drug for 1 month and then invited again to the department for recall and continue     standard treatment . The patient can choose whether to continue medication with one of the     drugs or stop this medication treatment. Total duration of the experiment is two and a half     months.   "
72280|NCT02339649|"     The main goals of this study are to provide a cognitive, neurological, brain morphological,     and serological profile of sepsis survivors in order to make long-term prognosis of recovery     and estimate the need for rehabilitation measures in order to help patients reintegrate into     normal daily life.   "
72281|NCT02339636|"     A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis   "
72282|NCT02339623|"     If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland     volume can accurately predict the likelihood of preterm birth in patients having symptoms and     signs of PTL , we would be able to use it as a valuable component for assessment and early     management of high risk pregnant women for PTB which can be positively reflected on the risk     of neonatal morbidity and mortality in those patients.   "
72283|NCT02339610|"     This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from     the time of surgery through the 6 month endpoint in patients with severely painful and/or     severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).   "
72284|NCT02339597|"     Primary hypothesis:      The objective compliance ( # of hours per night of APAP therapy) is higher in patients who     get the APAP treatment initiation at home due to the fact that they get better support by     telemetric control and the possibility of prompt interventions.      Secondary hypothesis:      Based on the higher support at the home APAP initiation the following parameters will be     better in comparison to the standard supply in laboratory:      Objective measures:        -  mask leakage        -  pressure        -  Apnea-Hypopnea-Index (AHI)      Subjective measures:        -  quality of life        -  sleepiness   "
72285|NCT02339584|"     The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL /     Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10     mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to     intraocular pressure (IOP)-lowering efficacy. This study will take place in China, Taiwan,     and Russia.   "
72287|NCT02339558|"     This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal     cancer that has returned after a period of improvement (recurrent) and/or has spread to other     parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor     growth in different ways by targeting certain cells.   "
72288|NCT02339545|"     This is an acute, observational, prospective, multi-center clinical study to evaluate     Coronary Flow Reserve using the Volcano FloWire® after treatment with Orbital Atherectomy and     stenting of de-novo severely calcified lesions due to Coronary Artery Disease. 15 subjects     will be enrolled in up to 3 active U.S. study sites. Subjects who undergo successful     revascularization using Orbital Atherectomy and stenting will be eligible for enrollment. All     enrolled subjects will be treated with the OAS and stenting and seen at 24 hours or at     discharge, whichever is earlier. The purpose of the study is to evaluate coronary artery flow     reserve following successful treatment of severely calcified coronary lesions with the OAS     and stenting.   "
72289|NCT02339532|"     The main objective of this multicenter study will therefore be to evaluate pathologic     complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® -     PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® -     PERTUZUMAB] according to the presence or not of TOP2A gene amplification in a population of     breast cancer patients with HER2 overexpression.      A very important objective of the study will be the evaluation of biomarkers that predict     response to treatment.   "
72291|NCT02339506|"     Models of stress such as hypoglycemia have identified that stress results the next day in     decreased baroreflex sensitivity. This project will test the hypothesis that these delayed     changes in autonomic nervous system function are secondary to a rise in ACTH. The     investigators will infuse cosyntropin versus placebo in a double-blind, crossover study in     healthy adults and measure the delayed effects on the autonomic system as measured by     cardiovagal baroreflex sensitivity.   "
72292|NCT02339493|"     Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc     scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter     confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin,     dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic     stroke in most patients with AF. However, despite widely available risk stratification tools,     five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis     for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The     investigators have previously demonstrated the efficacy of an alert-based computerized     decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in     at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal     is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with     nonvalvular AF or atrial flutter in a randomized controlled trial.   "
72293|NCT02339480|"     This project is to penetrate and consummate the research mechanism of massage therapy on     simple obesity. Latest researches indicate that the energy regulation network system of     hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result     in obesity. The research group have firstly conducted effect studies of massage therapy on     model of simple obesity rats and observed some neurobiological mechanism (whole effect     mechanism), meanwhile, the team have discussed influences on the development of preadipocyte     and function of endocrine with dynamic mechanical stimulation in vitro (local effect     mechanism). This research aims at centering on the hypothesis that massage therapy can act on     energy regulation network system of hypothalamus specifically, thus regulating the energy     metabolic disorders. Then applying functional magnetic resonance imaging (fMRI) to explore     whether patients with simple obesity exist abnormality on energy regulation network system of     hypothalamus, ascertain mechanisms how massage therapy treat energy metabolism disorders of     simple obesity, deepen mechanism study on how massage therapy prevent and treat obesity and     enrich the clinical application's scientific connotation that massage therapy treat simple     obesity.   "
72294|NCT02339467|"     Community walking is an issue that older adults with chronic conditions have described as     important to participation in the community. Walking outside the home is a universally     accessible form of physical activity that has multiple health benefits. Walking for 150     minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke,     diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads,     slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible     and can improve confidence, balance and walking ability. Being physically active outdoors in     nature appears to improve mental health more than being active indoors. Despite these health     benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers to     walking outside include fear, physical disability due to chronic disease, the appropriateness     of footwear and walking aids, and the physical environment, such as uneven pavement, weather     and temperature. To date, the best strategy for getting people to walk outdoors regularly is     unknown. The investigators propose to evaluate the effectiveness of a dynamic 1-day workshop,     at which older adults who infrequently walk outdoors learn strategies to facilitate outdoor     walking, such as appropriate use of footwear, ambulatory aids and equipment, goal setting,     and practice skills related to increasing outdoor walking. The workshop will be compared to     the workshop plus involvement in a walking group for 3 months. Outcomes include outdoor     walking activity, total physical activity, walking ability, participation, and health-related     quality of life. Each participant will have three evaluations: before the intervention and 3     and 6 months later. The investigators will interview select participants at 6 months to ask     them about their opinions of what worked and didn't work. Increasing outdoor walking is     expected to improve health and well-being, and help people live independently in the     community for longer.   "
72388|NCT02338232|"     This is single-center, open-label, prospective study of telmisartan for the prevention of     acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a     hematologic malignancy.   "
72295|NCT02339454|"     Low intensity shockwaves have been proven in animal and pilot clinical studies to induce     local growth of new blood vessels. Small single-center clinical trials with shockwave therapy     showed promising results in reducing angina symptoms, improving perfusion and contractility     in patients with refractory angina and stress-induced ischemia on imaging test.      The hypothesis of this study is that shockwave therapy could improve angina symptoms and     exercise tolerance in broader population of patients with stable angina regardless of imaging     test results Study aims to demonstrate anti-anginal efficacy of Extracorporeal Shockwave     Myocardial Revascularization Therapy (ESMR), on top of stable optimal medical treatment in     patients with stable angina.   "
72296|NCT02339441|"     The aim of the study is to compare the effectiveness of commonly used immunosuppressant     treatments for early diffuse cutaneous systemic sclerosis (SSc).   "
72297|NCT02339428|"     Patients will be randomized to receive diclophenac sodium or placebo two hours before     diagnostic colonoscopy. Intensity of pain as measured on a 10-point Likert scale will be the     primary outcome. Patients will be followed until hospital discharge, an average of 10 days.   "
72298|NCT02339415|"     The purpose of this study is to evaluate the effects of pharmacologic FXa inhibition (via     edoxaban 30 mg daily) on inflammation, as reflected in plasma Interleukin-6 levels.   "
72299|NCT02339402|"     Developing a new non-invasive prenatal test for single gene disorders from cell free fetal     DNA, retrieved from the mothers blood.   "
72300|NCT02339389|"     Epidural techniques offer the advantage of being able to titrate the level, density, and     duration of the blockade through the use of a catheter and are associated with relative     maternal hemodynamic stability. One of the disadvantages, however, include a raise in     maternal temperature that is attributed to labor epidural technique. This study will assess     if decreased maternal ventilation following induction of labor analgesia causes a raise in     temperature.   "
72333|NCT02338947|"     The purpose of this study is to determine whether off-pump coronary artery bypass graft     (OPCAB) surgery is superior to conventional on-pump coronary artery bypass graft (CABG)     surgery in the treatment of Pre-frailty and Frailty patients   "
72336|NCT02338908|"     Shoulder pain is highly prevalent in the society. The role of muscle tissues in this     pathology has received increasing interest. Some studies have proposed the role of myofascial     trigger points in this population. The purpose of the current clinical trial is to compare     the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus     the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on     pain and function in patients suffering from unspecific shoulder pain.   "
72301|NCT02339376|"     The overall goal of this study is to open up the promising treatment of repetitive     transcranial magnetic stimulation (rTMS), which has been shown to be effective against     seizures in patients with surface neocortical foci, to a much larger population of patients     with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are     not currently considered good rTMS candidates.      The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients     with deep seizure foci by targeting its usage to accessible cortical partner regions. In this     study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial     temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to     perform a randomized controlled assessment of repetitive transcranial magnetic stimulation     protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The     methods used in this study will include magnetic resonance imaging (MRI) of the brain,     electroencephalography (EEG), and transcranial magnetic stimulation (TMS).   "
72302|NCT02339363|"     The present study was a randomized controlled trial that explored the feasibility,     acceptability, and effectiveness of short-term mindfulness training among adolescents. The     primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress     Reduction components—sitting meditation and hatha yoga—on working memory, stress, anxiety and     mindfulness. The influence of daily home practice compliance on intervention outcomes was     also examined.   "
72303|NCT02339350|"     Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall     survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%,     thus recent studies focus on treatment intensification according to the risk group. According     to the previous reports, we designed a multicenter prospective trial for pediatric ALL.   "
72304|NCT02339337|"     This is an open label, randomized-controlled, comparative trial. HBV and HCV dually infected     patients with negative hepatitis B e antigen (HBeAg) were enrolled in the study. The     definition of HBV and HCV dual infection included seropositivity of HCV antibody (anti-HCV)     and HBsAg for more than 6 months, together with positive serum HCV RNA. Eligible subjects     were randomized into 2 groups at treatment initiation. Subjects who were randomized into the     genotype guided therapy (GGT) group received Peg-IFN and standard dose RBV (1200 mg/day) for     48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day)     for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for     6 months. For subjects who were randomized into the response guided therapy (RGT) group, the     duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype     1, a pre-treatment low viral load (LVL, < 400000 IU/mL) and RVR (defined asHCV RNA <50 IU/mL     at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype 2/3 and RVR.   "
72305|NCT02339324|"     This study plans to to estimate the safety profile of the combination biotherapy regimen     consisting of standard-dose interferon alpha-2b (HDI) and anti-PD1 monoclonal antibody,     Pembrolizumab, for the neoadjuvant therapy of locally/regionally advanced/recurrent melanoma.     Also, the objectives of this trial include the evaluation of prognostic and predictive     biomarkers, radiologic preoperative response rate, pathologic response rate, progression free     survival and overall survival. Up to 30 evaluable patients will be accrued.   "
72316|NCT02339168|"     This phase I trial studies the side effects and best dose of metformin hydrochloride when     given together with enzalutamide in treating patients with prostate cancer that has not     responded to previous treatment with hormones. Hormone therapy using enzalutamide may fight     prostate cancer by lowering the amount of androgens the body makes and blocking the use of     androgens by the tumor cells. Metformin hydrochloride, used for diabetes, may also help kill     tumor cells. Giving enzalutamide together with metformin hydrochloride may kill more tumor     cells.   "
72306|NCT02339311|"     One in three people will be diagnosed with diabetes by 2050, and the proportion will likely     be higher among Native Americans. Diabetes control is currently suboptimal in underserved     populations such as Zuni Indians despite a plethora of new therapies. Patient empowerment is     a key determinant of diabetes control, but such empowerment can be difficult to achieve due     to resource limitation and cultural, language and health literacy barriers. The investigators     will conduct a home-based chronic disease (diabetes) educational intervention using Community     Health Representatives (CHRs) to associate improvement in Patient Activation Measures scores     (primary outcome) and clinical indicators of diabetes control (secondary outcomes).   "
72307|NCT02339298|"     The purpose of the study is to evaluate whether intraoperative music application has a     positive impact on postoperative behavior in children and adolescents.   "
72308|NCT02339285|"     Investigating the effects of non-invasive transcranial alternating current stimulation (tACS)     on patients with Major Depressive Disorder (MDD).   "
72309|NCT02339272|"     The aim of this study was to assess meiotic recombination in primary spermatocytes,     synaptonemal complex length and the correlation with chromosomal abnormalities in testicular     spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA).   "
72310|NCT02339259|"     Background:      The clinical features and prevalence of tropical rickettsial illnesses such as murine and     scrub typhus in Bangladesh are unknown. Following testing for malaria, patients with     undifferentiated fever are frequently treated empirically for typhoid or diagnosed clinically     with a viral fever. Since murine and scrub typhus are common causes of fever in other     countries in the region, it is likely they are prevalent in Bangladesh. Murine and scrub     typhus may be treated cheaply and effectively with doxycycline.      Primary aim:      - Describe the clinical features of scrub and murine typhus in Bangladeshi patients      Secondary aims:        -  Assess the proportion of patients screened for malaria having rickettsial illnesses        -  Understand the pathophysiology of severe scrub typhus and murine typhus        -  Prospective evaluation of rapid diagnostic tests for scrub and murine typhus      Methods:      Scrub typhus and murine typhus rapid tests will be introduced to CMCH in conjunction with     existing malaria testing facilities. Consenting febrile adult patients who have had malaria     and typhus rapid tests and meeting the entry criteria will be enrolled. Samples will be saved     for serology and real time polymerase chain reaction (PCR) testing for O. tsutsugamushi and     Rickettsia spp. A thorough history and examination will be undertaken. Hemodynamic status     will be assessed by ultrasound upon enrolment. Patients will be followed up for outcome and a     second sample will be taken for convalescent serological testing on day 14 where possible.      Analysis The proportion of patients screened for malaria with an acute febrile illness due to     scrub typhus and murine typhus will be calculated. The clinical features of scrub and murine     typhus, malaria and patients negative for these conditions will be compared. Healthy subject     samples will be used to provide normal ranges. The sensitivity and specificity of the rapid     tests will be assessed as compared to the gold standard of PCR and serology combined.   "
72311|NCT02339246|"     The purpose of the study is to compare the pharmacokinetic parameters of three different     formulations of tacrolimus.      Eligible patients will be treated with all three formulations in a pre-defined sequence.   "
72362|NCT02338570|"     Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer     in treatment with everolimus and previously treated with a Vascular endothelial growth factor     (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)   "
72414|NCT02337894|"     The purpose of this study is to assess the effect of an eight-week dietary supplementation     with essential amino acids plus arginine on liver and plasma lipid content, whole-body fat     oxidation, whole-body insulin sensitivity, whole body protein metabolism, and body     composition in obese pre-pubertal children.   "
72312|NCT02339233|"     The overall aim is to assess whether task specific locomotor training and spinal cord     electrical stimulation (SCES) can induce neural reorganization of the functionally isolated     human spinal cord to improve standing and stepping in individuals with functionally complete     SCI. The investigators propose that locomotor training will result in generation of more     effective standing and stepping efferent patterns by restoring phase dependent modulation of     reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The     investigators propose that the SCES will optimize the physiological state of the spinal cord     interneuronal circuitry compromised by compensating for loss of supraspinal input for the     retraining of these tasks.      The proposed studies will allow us to gather critical information using commercially     available electrodes to design the more advanced multi-electrode array technique that will be     adaptive and conceivably be effective in a wider range of patient populations. The current     electrodes used in this study will serve two objectives: 1) to improve standing and stepping     with the combination of epidural stimulation and locomotor training in individuals with     functionally complete SCI; and 2) to provide critical information for the development of more     advanced electrodes.   "
72313|NCT02339220|"     The purpose of this study is to determine the value of Constraint-Induced Movement therapy     (CIMT) for improving motor function and general fitness in adults with subacute and chronic     traumatic brain injury (TBI), particularly TBI acquired during active military duty, in     comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the     effect of a set of enhanced versus standard procedures for transferring therapeutic gains     from treatment setting to everyday life. Lastly, this study will determine whether any     therapeutic effects observed are correlated with neuroplastic white matter or grey matter     changes.   "
72314|NCT02339207|"     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,     tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV)     and subjects with CHC infection.   "
72315|NCT02339194|"     BACKGROUND: The literature has shown that simplified methods for complete denture fabrication     can be as effective as the traditional techniques, but with less expenditure of time and     resources, without prejudice to the patients. However, the effectiveness of these simplified     methods for patients with more complex medical conditions haven't been deeply explored.      OBJECTIVES: To evaluate the effectiveness of a proposed simplified method for complete     dentures fabrication for patients with severely resorbed mandibular alveolar bones.      METHOD: edentulous patients requesting treatment with bimaxillary complete dentures in a     university clinic will be rehabilitated following a simplified technical proposal, being     divided randomly into two groups according to the mandibular arch molding technique. In group     A, a single impression with alginate through pre-fabricated trays will be performed, while     patients allocated in group B will receive a second molding with a more complex technique.     After 3 and 6 months, besides important clinical parameters, it will be investigated aspects     related to patient's perceptions about the success of treatment. The study will be conducted     with a minimum of 30 participants per group, and comparisons between the two groups will be     made by means of tests suitable for distribution of data.   "
72317|NCT02339155|"     This study, as a post-marketing commitment to the Food and Drug Administration, is designed     to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a     healthy volunteer population. This is a randomized, open-label, parallel group, two arm study     to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is     administered alone or concomitantly with raxibacumab. The study is planned to enroll     approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be     approximately 26 weeks. The dates reflect cohort 1.   "
72318|NCT02339142|"     Thyroid eye disease is an autoimmune disorder affecting approximately 50% of individuals with     autoimmune thyroid diseases resulting in enlargement of ocular muscles and may lead to     congestion of the eyelids and ocular surface, ocular movement restriction and double vision,     and optic nerve compression and loss of vision.      First line medical therapy is oral or intravenous corticosteroids (CS), which several studies     have shown results in reduction of soft tissue congestion, but some studies suggesting that     ocular restriction or visual loss may still occur in spite of CS therapy.i      External beam radiotherapy (XRT) is second line therapy but is controversial, with some     studies suggesting benefit in preventing onset of double vision or optic nerve compression     while other studies suggest it has no benefit. Most proponents of XRT for TED believe that it     is most effective early in the disease evolution. XRT has been shown to be a safe therapy     with few side-effects, although retinopathy changes have developed in a small percentage of     diabetics and its use is avoided for diabetics.      Combined oral prednisone and XRT has been shown to be more effective in reducing soft tissue     inflammation and motility complications than either monotherapy in two different studies.      To date there have been no trials comparing combined XRT and iv CS with iv CS alone for early     progressive TED to identify potential benefit in reducing the severity of motility disorders     or preventing the onset of dysthyroid optic neuropathy. That is the purpose of this study.   "
72319|NCT02339129|"     This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled,     parallel-group study designed to determine the dosing interval, efficacy and safety of     SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the     treatment of pain associated with DOMS.   "
72366|NCT02338518|"     Chemotherapy is an important therapeutic method for unresectable gastric cancer patients.     However, there is currently no established standard chemotherapeutic regimen for gastric     cancer. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX     regimens. The investigators estimate that combined intravenous and intra-arterial intensified     SEEOX neoadjuvant chemotherapy may be a safe and promising regimen in unresectable gastric     cancer patients.   "
72367|NCT02338505|"     Phase II prospective single-institutional study.   "
72320|NCT02339116|"     Bev improves the efficacy of first-line chemotherapy in unresectable mCRC. In the phase III     TRIBE trial upfront FOLFOXIRI plus bev provided a significant advantage in terms of PFS and     RR compared to FOLFIRI plus bev. A trend toward better OS was also evidenced. The second-line     treatment was at investigator's choice. A manageable increase in diarrhea, mucositis and     neutropenia was reported, while no differences in febrile neutropenia, serious adverse events     and toxic deaths were evidenced.      A growing amount of data support the clinical relevance of achieving an early and deep tumor     shrinkage.      Phase III TML and BEBYP trials demonstrated that the continuation of bev beyond disease     progression combined with a switched chemotherapy regimen provided a significant advantage in     terms of OS and PFS.      Based on recent evidences, the partial interruption of the upfront induction chemotherapy     before disease progression and the prosecution of bev until disease progression as     maintenance treatment is a valid strategy in the treatment of mCRC.      On the basis of these considerations, a first-line doublet plus bev followed by a second-line     switched doublet (from oxaliplatin to irinotecan and viceversa) plus bev should be considered     a standard option for mCRC patients. Only retrospectively collected data are currently     available about the efficacy of first-line FOLFOXIRI plus bev followed by second-line     rechallenge with FOLFOXIRI plus bev. We therefore designed the present phase III randomized     trial of first-line FOLFOXIRI plus bev followed by reintroduction of FOLFOXIRI plus bev at     progression versus FOLFOX plus bev followed by FOLFIRI plus bev at progression in first- and     second-line treatment of unresectable mCRC patients.   "
72321|NCT02339103|"     The purpose of this study is to compare two novel active rewarming techniques in mildly     hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14     degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids     (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize     that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will     prove to provide significantly superior rewarming rates than shivering alone.   "
72322|NCT02339090|"     The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of     treatment effect against daily injections of rhGH.   "
72323|NCT02339077|"     This is a descriptive study to determine the role of fetal GBS disease as a cause for     stillbirths   "
72324|NCT02339064|"     This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous     apomorphine infusion in subjects with advanced Parkinson's Disease (PD) whose motor     fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one     other class of drugs or mode of therapy for PD.   "
72325|NCT02339051|"     Osteoporosis is a large public health disease, characterized by low bone mass and micro     architectural deterioration of bone tissue, resulting in enhanced bone fragility and     consequent increase in fracture risk. Osteoporosis is present when bone mineral density (BMD)     or content (BMC), measured by dual-energy X-ray absorptiometry (DXA), is more than 2.5 SDs     below the mean value of the young adult. BMD measured by DXA is a surrogate measure of bone     strength and is the primary determinant of fracture risk in both men and women. However, the     majority of fragility fractures occur in women and in individuals who do not have     osteoporosis according to these standards, indicating that BMD is just one among several     indicators of bone health and that assessment of fracture risk should also rely on other bone     properties. Newer imaging methods, such as quantitative computerized tomography (QCT), can     complement information from DXA-measurements due to its ability to assess volumetric BMD and     bone geometry and to differentiate between cortical and trabecular bone compartments. Bones     are composite materials made predominantly of living cells, extracellular matrix, water and     lipids. This composite nature of the bone material enables it to absorb stresses by elastic     deformation and to endure high loads before fracturing. A new in vivo measurements of bone     material strength can be used to evaluate bone mechanical properties and thereby the fracture     risk. It is well established that the skeleton benefits, in terms of increased density, from     regular physical activity. However, changes in BMD are still the main surrogate for assessing     improvements in exercise-induced bone health despite the experimental findings as well as     findings in humans showing that improvements in mechanical bone properties are independent of     changes in BMD. These improvements in mechanical bone properties may be due to changes in     bone shape or matrix composition. It could then be argued that a decrease in BMD is only one     of the possible manifestations of osteoporosis and that bone strength or fragility is     multifactorial. The objective for this study is to investigate the role of mechanical loading     on bone material strength and bone microarchitecture in middle-aged women. The overall     hypothesis is that mechanical loading is a regulator of bone material strength and     microarchitecture in middle-aged women. This is an intervention study where the participants     will act as their own controls. The investigators intend to include 40 postmenopausal and     healthy women 50-60 years of age in the study. Advertisements in local papers and at the     hospital will be used to come into contact with suitable study subjects. The women will be     asked to perform an intervention program, including jumping on one leg every day during a     3-month period according to a protocol with a gradually increasing load/number of jumps. The     women have to choose one of their legs as intervention-leg and stick to the chosen leg     throughout the study. The leg without intervention will be used as a control. Both bone     material strength (BMS) and bone microarchitecture will be measured before and after     intervention in both legs (tibia). The operators measuring BMS (OsteoProbe®) and bone     microarchitecture (high resolution pQCT) will be blinded concerning each participant's choice     of leg for intervention. In addition, subjects will be asked to register daily physical     activity in a structured diary. The primary outcome measure will be changes in bone material     strength (BMS) in the lower leg (tibia) with intervention compared to the leg (tibia) without     intervention. Participants will attend two clinic visits, at baseline and after 3 months when     the intervention period is completed. The secondary outcome measures will be changes in total     volumetric density, cortical volumetric density, cortical cross sectional area and trabecular     bone volume fraction in the lower leg (tibia) with intervention compared to the leg (tibia)     without intervention.   "
72338|NCT02338882|"     During cataract surgery an artificial lens is implanted in the eye. These artificial lenses     are called intraocular lenses (IOLs) and there are many different types of IOL designs. IOLs     are of fixed focus and so unless a multifocal IOL is used you would need to wear spectacles     for viewing near objects. This study has been designed to look at how well a multifocal IOL     corrects distance and near vision in comparison with a conventional monofocal IOL. Both types     of IOLs are commercially available and are commonly implanted. Using new non-invasive methods     we hope to be able to better judge the visual performance of these IOLs. In addition the     study will involve imaging and examining the IOLs to determine the prevalence of any     post-operative complications.   "
72389|NCT02338219|"     The purpose of this study is t o evaluate levator ani morphology following normal vaginal     delivery and cesarean section (elective and emergent), using three-dimensional (3D)     ultrasound, and to study the effect of mode of delivery on female sexual function.   "
72326|NCT02339038|"     Background:      - Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes     from a combination of medicines that is yielding high cure rates. But its long-term effects     are uncertain. One problem is that a lot of people need the treatment, but only a few     specialists can give it. The success rate for Hepatitis C treatment by primary care doctors,     nurse practitioners, or physician assistants is largely unknown. Researchers want to see how     provider type affects treatment outcomes. They will conduct a large, community-based study in     the District of Columbia.      Objectives:      - To see if people can be treated for Hepatitis C safely and successfully in community-based     health centers.      Eligibility:      - Adults who need treatment for chronic Hepatitis C infection.      Design:        -  Participants will be screened with blood tests. Their current medicines will be          reviewed.        -  Participants will give researchers access to their medical records. Researchers will          follow participants through these records.        -  Participants will see a primary care or infectious disease provider. The provider will          tell them about their treatment. They will be told how often they will visit the          provider and how often they will have their blood drawn. They will get a calendar of          study visits.        -  Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care          provider monthly.        -  Participants will have monthly follow-up visits for up to 3 months after they finish          their medicine.        -  Participants will have yearly follow-up visits with their care provider for up to 10          years.   "
72327|NCT02339025|"     Background:      - Researchers at the National Cancer Institute and the Department of Defense are trying to     learn more about what causes cancer, heart disease, and other health problems. To do this,     they gather data on risk factors and biological markers. They get these data from large     groups of people in long-running studies. As these groups of people age, researchers must     form new groups. TRICARE is a health insurance program for uniformed service members and     their families. It is a major part of the Military Health System. Researchers hope to form a     new study group from TRICARE members. This study will test if TRICARE members will take part     in a research study.      Objectives:      - To test if TRICARE members will take part in a research study.      Eligibility:      - TRICARE members aged 35 74 with military primary care providers at Walter Reed National     Military Medical Center. They must not have a prior diagnosis of cancer other than     non-melanoma skin cancer.      Design:        -  Participants will fill out a survey. It will ask about their risk factors for cancer and          other chronic diseases. Their medical records will be reviewed. They will give a blood          sample.        -  If a larger study is formed, then participants data will be used in the larger study.          They may be asked to give more samples.   "
72334|NCT02338934|"     This is a single arm, open-labelled study to determine the effectiveness of combination     Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients     with ESRF on haemodialysis. Patients will be started on PO Cinacalcet 25mg OD + PO/IV active     Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4     weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached     2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active     Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased.      Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and     Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit     normal at 6, 12 and 24 months will be determined   "
72335|NCT02338921|"     To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in     type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two     drug combination therapy with glimepiride and metformin.   "
72328|NCT02339012|"     Background:      - Biomarkers are substances in people s blood and tissues. They help researchers understand     diseases and signs of aging. Scientists want to do more research on biomarkers to find ways     to improve quality of life in old age.      Objective:      - To learn more about biomarkers and their relationship to aging.      Eligibility:      - Adults at least 20 years old who weigh at least 110 pounds and have a body mass index below     30. They must agree that their genetic samples can be collected, studied, and stored.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests. They will have heart tests and nurse will assess their veins. They will fill out          a questionnaire.        -  Participants will have a 2-day baseline visit. Then they will return every 2 years for          up to 10 years. These follow-up visits will repeat the baseline visit:        -  Repeat of screening procedures.        -  Physical performance tests like balance and walking tests.        -  Leg and grip strength tests.        -  Health and mental state questions.        -  Memory and problem solving tests.        -  Cytapheresis. Blood will be removed through a needle in the vein of one arm and run          through a machine. The blood will be returned through a needle in a vein of the other          arm.        -  Visits may also include:        -  Magnetic resonance imaging scans. Participants will lie on a table that slides in and          out of a machine that takes pictures.        -  Diabetes test. After fasting, participants will drink a sweet drink and give blood.        -  Breathing and walking tests.        -  Wearing a device that record physical activity.        -  Scan of the abdomen and the right leg.        -  A small amount of muscle tissue and/or skin removed.   "
72339|NCT02338869|"     Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based     psychosocial intervention for stroke acute survivors in primary care one to six months     poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary     outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention     group or control group. Patients are followed up for 12 months.   "
72340|NCT02338856|"     The purpose of this study is to investigate the safety and tolerability of MB12066 after     multiple dose and to investigate the pharmacokinetic characteristics of MB12066 after     multiple dose.   "
72341|NCT02338843|"     This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult     patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple     centers globally.   "
72342|NCT02338830|"     To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in     asymptomatic twin pregnancies who have sonographic short cervix   "
72329|NCT02338999|"     Background:      - Lupus causes a person s immune system to attack the body. It can cause blood vessel     problems, heart attack, or stroke. Researchers want to see if the drug pioglitazone may help.      Objectives:      - To see how well pioglitazone improves blood vessel function and decreases blood vessel     inflammation. To study its effect on lupus symptoms.      Eligibility:      - Adults at least 18 years old with lupus.      Design:        -  Participants will be screened with medical history, heart test, and blood and urine          tests. They may have a bone density test.        -  Visit 1:        -  Participants will have:        -  Physical exam and blood drawn.        -  Peripheral Arterial Tonometry (Endopat). A cup will be placed on the finger and a          pressure cuff on the arm.        -  Cardio-ankle vascular index (CAVI) and/or Sphygmocor. Electrodes will be placed on both          wrists, a microphone on the chest, and a blood pressure cuff on each arm and leg.          Another test will involve placing a small device on a fingertip.        -  18-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography          (PET/CT) (some participants). A radioactive sugar will be injected into a small plastic          tube in an arm vein. Participants will lie on a bed that moves in and out of a scanner          that takes pictures.        -  Participants will get a 3-month-supply of the study drug or placebo. After 1 week, their          dose may increase.        -  After those 3 months, they will not take either drug for 8 weeks. Then they will switch          and take the other drug for 3 months.        -  Participants will have 6 more visits over 8 months after Visit 1. Tests from Visit 1 may          be repeated. They may have a urine test.   "
72330|NCT02338986|"     Background:      - There are more emerging infectious diseases recently. Some could affect many people. Some     like Severe Acute Respiratory Syndrome (SARS) or Middle East Respiratory Syndrome (MERS) are     caused by new germs. Sometimes known germs suddenly infect new and large areas, like Ebola.     Many of these diseases don t have good treatments available. Researchers may be able to     develop a treatment by using antibodies against these infections.      Objective:      - To collect antibodies from people with high levels of antibodies to the diseases being     studied.      Eligibility:      - Healthy men 18-70 years old who weigh at least 110 pounds. They may have been infected with     or vaccinated for one of the new infections researchers are studying.      Design:        -  Participants will be screened with medical history and blood tests. Researchers will          determine if the participant can have apheresis.        -  Participants will have apheresis. First, they will be interviewed. Then, a needle will          be placed in a vein. Blood will be drawn, and a machine will separate the blood cells          from the antibodies and protein. The blood cells will then be returned to the          participant through another vein. It takes about 60 minutes for the actual collection.        -  Participants will be asked to have the procedure at least 3 times. They can participate          in up to 20 sessions total as part of this study. There must be at least 7 days between          sessions.   "
72331|NCT02338973|"     Background:      - People with rod-cone dystrophy (RCD) or enhanced S-cone syndrome (ESCS) have excess fluid     under the retina of their eye. This can cause vision loss. The medicine interferon gamma-1b     may help people with these diseases.      Objectives:      - To see if interferon gamma-1b eyedrops are safe for people with RCD or ESCS. To see if the     medicine can decrease retina fluid and help prevent vision loss.      Eligibility:      - People at least 12 years old with RCD or ESCS. Those with ESCS must have two mutations in     the NR2E3 gene.      Design:        -  Participants will be screened with medical history, physical exam, eye exam, and blood          tests.        -  Participants will stay at NIH for 2 days and get the first eyedrops.        -  Participants will give themselves 4 study eyedrops 4 times daily for 2 weeks and keep a          diary.        -  Participants will have 2 phone calls and 5 outpatient visits over 8 weeks. They may          have:        -  Repeats of screening tests.        -  Questionnaires.        -  Small piece of skin removed.        -  Eye exams, including eye dilation and tasks on computer screens.        -  Fluorescein angiography. A dye injected into an arm vein will travel to the blood          vessels in the eyes. A camera will take pictures.        -  Electroretinography. Participants will sit in the dark wearing eyepatches. A small          electrode will be taped to the forehead. After 30 minutes, researchers will remove the          eyepatches and put in numbing eyedrops and contact lenses. Participants will watch          flashing lights.        -  Electrooculography. Electrodes will be attached outside of the eyes and eye function          will be measured in the dark and the light.        -  Participants will have a follow-up visit after 52 weeks.   "
72332|NCT02338960|"     A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an     Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered     subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without     decreased arousal) in premenopausal females.   "
72471|NCT02337153|"     Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of     treatment and tooth movement.   "
72337|NCT02338895|"     Acute Kidney Injury (AKI) develops in 88% to 30% of critically ill patients admitted to an     intensive care unit and is a strong predictor of mortality.Therefore any management strategy     that prevents progression of renal risk to injury or failure has the potential to improve     outcomes in these patients.Conventional management of acute oliguria in shock has been to     blindly 'push' fluids to improve renal perfusion or to give loop diuretics once fluid loading     has been considered as accomplished. However both volume overload and 'blind' attempts at     fluid removal can worsen renal injury and have been associated with higher mortality by     venous overcongestion and inappropriate hypovolemia. It seems reasonable to assume that a     bedside test to visualize volume status and renal perfusion may assist in improving outcomes     in this cohort.The investigators developed a goal-directed ultrasonographic protocol to     provide immediate hemodynamic information in acutely oliguric patients with shock as well as     a management algorithm for guiding therapy. The investigators incorporated IVC diameter     measurement, respiratory variation and response to a passive leg raise to assess whether     further fluid boluses were required and a measurement of renal perfusion to determine whether     diuretics or renal replacement therapy were indicated. The investigators aim to measure the     effects of this management protocol on the rates of AKI in the study participants as compared     to prior to the implementation of the protocol.The study design is a prospective,     observational. Since this is a proof of concept study, the projected sample size is 40     patients. An interim analysis will be carried out after 20 patients are enrolled and a     further 20 will be enrolled as necessary   "
72343|NCT02338817|"     Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia,     putting them at risk for several complications, such as hepatomegaly, adenomas, and     cirrhosis. As of now, glycogen storage disease patients are limited to using finger stick     glucose meters to monitor their glycemia at home. Diabetes Sentry, a non-invasive     hypoglycemia detector designed like a watch, has been available for diabetic patients to     non-invasively alert for hypoglycemia, but has never been tested in a GSD population. The     investigators propose to test the accuracy of the Diabetes Sentry on patients with GSD types     0, I, III, VI, and IX, by measuring their metabolic markers every two hours, as well as     whenever the device alerts for hypoglycemia. If accurate, it could be a useful tool for GSD     patients in managing hypoglycemia, both clinically and at home.   "
72344|NCT02338804|"     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).     Enrolled patients will receive standard treatment according to National Comprehensive Cancer     Network (NCCN) guide line with or without combining MV injection. The efficacy and side     effect will be compared between the two groups.   "
72345|NCT02338791|"     The purpose of this study is to measure the amount of movement between the bones of the     shoulder joint when mobilization techniques are applied by a physical therapist.   "
72346|NCT02338778|"     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).     Enrolled patients will receive standard treatment according to National Comprehensive Cancer     Network (NCCN) guide line with or without combining MV injection. The efficacy and side     effect will be compared between the two groups.   "
72347|NCT02338765|"     The purpose of the 12-week study is to determine if competing a physical activity program     with a buddy helps increase daily physical activity when compared to completing the same     physical activity program without a buddy.   "
72348|NCT02338752|"     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).     Enrolled patients will receive standard treatment according to National Comprehensive Cancer     Network (NCCN) guide line with or without combining MV injection. The efficacy and side     effect will be compared between the two groups.   "
72363|NCT02338557|"     Study was conducted Effectiveness of Motor Relearning Programme and Mirror Therapy along with     Conventional Physiotherapy treatment for improving Hand Function In Patients with stroke.     study was an experimental study conducted on 12 stroke patients using convenient sampling     method .Subjects were divided into two equal groups (n=6). Group A was given conventional     physiotherapy and Motor Relearning Programme exercises for the affected hand and Group B     received conventional physiotherapy for the affected hand and mirror therapy for the     unaffected hand. Chedoke arm and hand inventory (CAHAI) was used as primary outcome measure     for evaluation of hand function before and after application of therapeutic Intervention   "
72364|NCT02338544|"     The purpose of this observational trial is to assess application and convenience of Epiduo®     PUMP under daily clinical practice conditions in patients with moderate to severe     inflammatory acne.   "
73253|NCT02326935|"     The intent of this clinical study is to answer the questions: 1) is the proposed treatment     safe and 2) is treatment effective in improving the disease pathology of patients with     Multiple Sclerosis and clinical outcomes.   "
72349|NCT02338739|"     Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment     often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A     strategy to optimize retention within resource constraints is urgently needed. Sequential     adaptive strategies - a novel class of public health approaches - may offer a solution. A     candidate sequential adaptive strategy would start with a less expensive intervention (e.g.,     SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to     patients who show early signs of poor retention. This study involves a sequential multiple     assignment randomized trial to evaluate a family of such strategies. the investigators will     randomize 2,500 adults newly initiating antiretroviral treatment (ART) at 4 HIV clinics in     the Nyanza region of Kenya to (1) standard of care routine education and counselling (REC),     (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening     retention (defined as the first time a patient is 14 days late for an appointment) will be     re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with     vouchers, or (3) a peer navigator. Patients not successfully contacted by 28 days after     missed visit (and not verified to have left the area or transferred to another clinic) will     also be rerandomized to of one the same three re-engagement interventions. Individuals     randomized at first stage to SMS or voucher that do not miss a visit by at least 14 days in     the first 12 months of follow up will be re-randomized at 12 months to stop first stage     intervention or continue with that same intervention to 24 months. The investigators primary     objective is to assess the comparative effectiveness of sequenced intervention strategies to     prevent initial lapses in retention and to treat those that occur. The investigators primary     endpoint is alive and virologically suppressed two years after enrolment. In addition, the     investigators will assess the comparative effectiveness of first-stage strategies (REC, SMS,     voucher) to prevent lapses in retention, and the comparative effectiveness of second stage     strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse.     This study will also compare outcomes among patients who continue versus discontinue the SMS     and voucher interventions, including a small complementarity component utilizing qualitative     methods to examine the voucher approach and the effects of discontinuing this approach after     success among a subset of participants. At study conclusion the investigators output will be     a menu of adaptive strategies for retention, accompanied by estimates of cost and     effectiveness, which policy makers in different settings can use to advance the impact of HIV     care and treatment programs in Africa.   "
72350|NCT02338726|"     To assess pelvic floor symptoms and quality of life in elderly women.   "
72351|NCT02338713|"     The purpose of this study is to demonstrate that the intestinal absorption of calcium from a     novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg)     and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in     urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.   "
72352|NCT02338700|"     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).     Enrolled patients will receive standard treatment according to National Comprehensive Cancer     Network (NCCN) guide line with or without combining MV injection. The efficacy and side     effect will be compared between the two groups.   "
72353|NCT02338687|"     The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is     the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational     intervention, compared to the educational intervention alone, in the prevention of     preeclampsia and hypertensive disorders during pregnancy.   "
72354|NCT02338674|"     Patients with chronic hepatitis B infection (CHI) awaiting assisted reproduction usually     require antiviral therapy due to vertical transmission risk and laboratory safety. However,     no consensus is reached regarding the medication. This study aimed to explore the efficacy     and safety of tenofovir (TDF) and telbivudine (LdT) in this population.   "
72355|NCT02338661|"     This study is a prospective, single-center, postmarket clinical observation to observe the     clinical and radiographic long-term performance of the SBG hip stem.   "
72356|NCT02338648|"     The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as     compared with placebo TDS in the treatment of chalazion based on the proportion of subjects     that have complete response. Complete response is defined as the absence of any significant     clinical signs of a chalazion with possible scaring or skin defects resulting from healing of     the chalazion allowed.   "
72357|NCT02338635|"     Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal     dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage     during PD still remain unclear, generation of Endoplasmic reticulum (ER) stress may be     responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA) is a powerful     inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis in the     investigators in-vitro study. In this study the researchers investigated the hypothesis that     URSA protect peritoneal membrane damage.   "
72358|NCT02338622|"     This is a phase I trial of the combination of the PARP inhibitor olaparib and AKT inhibitor     AZD5363.      There are two parts to this study. Part A: dose escalation, and Part B: dose expansion.      Part A will investigate the combination of 300 mg bd of olaparib with intrapatient ascending     doses of AZD5363 administered for either 4-days-on, 3-days-off, and 2-days-on, 5-days-off.      Once the Maximum Tolerated Dose (MTD) is reached for both arms (or under the advice from the     Safety Review Committee (SRC) one of the schedules will be discontinued), the schedule with     the optimum safety and PK/PD profile will be taken forward to a dose expansion phase (Part     B).      Part B will evaluate the optimized dose/schedule identified in Part A of the study in     patients with (1) BRCA1/2 mutant cancers (with previous disease progression on PARP inhibitor     monotherapy), or (2) advanced sporadic tumours (e.g. TNBC, CRPC, HGSOC and tumours with     somatic mutations or other aberrations known to result in a hyperactivated PI3K-AKT pathway).   "
72359|NCT02338609|"     The primary objective of CRAD001M2305 is to report the long-term effects of everolimus     treatment on height, weight and sexual development (using Tanner Stages) in children and     adolescents with Tuberous Sclerosis Complex (TSC)-associated with Subependymal Giant Cell     Astrocytoma (SEGA). The study will monitor the growth and development of pediatric patients     with TSC-associated SEGA, previously enrolled in CRAD001M2301 until they reach Tanner Stage     V, or until age 16 for females or 17 for males whichever occurs first.   "
72360|NCT02338596|"     As clinical and radiographic performance of an ultra-short anatomic cementless stem have been     investigated only two randomized controlled studies, well-designed trials should aim for a     thorough comparison of the outcomes of ultra-short and conventional cementless stems. The     purpose of this study was to compare the outcomes of ultra-short and conventional stems in     the same young patients who underwent simultaneous bilateral sequential total hip     arthroplasties.   "
72361|NCT02338583|"     This prospective, single-arm multi-center study will provide clinical data in an     observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler     Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS     lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals     undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of     care (SOC), and who meet study entry criteria, may be enrolled.      Study procedures will include a wedge resection, wedge resection followed by lobectomy of the     same lobe, or lobectomy.   "
72369|NCT02338479|"     This is a prospective non-therapeutic study, assessing the long-term toxicity of pediatric     HCT for hematologic malignancies. This study is a collaboration between the Pediatric Blood     and Marrow Transplant Consortium (PBMTC), the Center for International Blood and Marrow     Transplant Research (CIBMTR), the National Marrow Transplant Program (NMDP) and the Resource     for Clinical Investigation in Blood and Marrow Transplantation (RCI-BMT) of the CIBMTR. The     study will enroll pediatric patients who undergo myeloablative HCT for hematologic     malignancies at PBMTC sites.   "
72370|NCT02338466|"     Proximal Middle Cerebral Artery (MCA) occlusions constitute the most severe stroke.     Intra-venous thrombolysis with rt-PA within the first 4,5 hours is the only proven effective     treatment. Prognosis is closely related to the recanalization rate that reaches only 30 to     50%. A new therapeutic strategy consisting in a sequential intravenous (IV) thrombolysis by     rt-PA followed by 50UI/kg of IV tenecteplase (TNK) has been proposed in case of no     recanalization after rt-PA. A case series of 13 consecutive patients treated by this     association has been published in 2011. A high rate of recanalization without hemorrhagic     transformation increase has been reported. However, efficiency and safety of this therapeutic     have to be assessed in a randomized multi-centric study. Such a study is of great interest     since interventional neuroradiology has not already shown superiority regarding IV rt-PA.     Moreover interventional neuroradiologists specialists are only available in major hospital     and an IV sequential strategy could provide an interesting alternative.      Main study objectives:      Main Clinical Objective:      Sequential thrombolysis should be associated with a significant better outcome at 3-month,     assessed by the modified Rankin score (mRS).      Main Radiological Objective:      Sequential thrombolysis should be associated with a higher rate of recanalization (TIMI 2b/3)     at 24-hour.   "
72371|NCT02338453|"     This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an     augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in     adults. It is expected that ABMT vs. control training condition would achieve better     therapeutic outcomes as indicated reduction in symptoms.      Participants from three groups (estimated 40 patients) will be offered to participate in the     study   "
72372|NCT02338440|"     Veno-occlusive disease (VOD) after hematopoietic stem cell transplantation (HSCT) remains the     major complication. VOD occurs in 11-31% of pediatric HSCT and the mortality reaches up to     50%.      Prostaglandin E1 (PGE1) have been reported to prevent and relieve the severity of VOD by     Gluckman et al.. Lipo-PGE1 is a transporter of PGE1, which is superior in concentrating PGE1     and acts for prolonged time. Because of the prolonged effective time, lipo-PGE1 acts     comparable effects by 1/4~1/8 of PGE1 dose. Empirically, pediatric HSCT centers adopt     lipo-PGE1 in dose of 1 mcg/kg/day (0.042 mcg/kg/hr), which is 1/7 of the dose recommended by     Gluckman, et al. This prospective study will investigate the concentration of lipo-PGE1 with     preventive lipo-PGE1 with empirical dose (1 mcg/kg/day).   "
72390|NCT02338206|"     The long down regulation protocol is widely used in the in vitro fertilization cycles, now it     will be assessed regarding its efficacy, in poor responder females undergoing in vitro     fertilization cycles, alone and after the addition of growth hormone.   "
72373|NCT02338427|"     Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid     proteins involved in the formation of abnormal tissue deposits. There are approximately 30     proteins involved in amylose's constitution. The therapeutic management varies depending on     the type of amyloidosis observed.      The application of conventional techniques immunolabeling of amylose does not allow the     comprehensive characterization of amylose forms, due to failures of the technic, the false     positivity of some results, or lack of frozen tissue available for typing light chain     (lambda, kappa).      In this study, the main objective is the comparison of two capacity of amylose     characterisation: immunohistochemistry and proteomics analysis.      The purpose of this study is to validate the superiority of proteomic analysis by     demonstrating the improvement of the precision, the reduction of technical failure, as well     as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.   "
72374|NCT02338414|"     The aim of this study is to evaluate the efficacy of romiplostim administered at every other     week in ITP patients who attained stable platelet counts ≥ 50 x 109/L for 4 consecutive weeks     after weekly doses of romiplostim.   "
72375|NCT02338401|"     Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This     reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy     expenditure of tissues (Manini 2010).      It has also been shown that as we age there is a:        -  Concomitant reduction in basal fat and carbohydrate oxidation, most likely due to the          decrease in RMR than to a change in respiratory exchange ratio (RER) (St-Onge and          Gallagher 2010).        -  A change towards a more saturated membrane of different tissues (Rabini et al 2002).      Incorporation of omega-3s, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), into     cell membranes may alter energy metabolism by:        -  Increasing the rate at which proteins operate (Hulbert 2007).        -  Promoting the release of EPA and DHA into the cytosol which will act as ligands for          peroxisome proliferator-activated receptors (PPARs) (Calder 2011). PPARs play an          important role in energy homeostasis by regulating genes involved in lipid metabolism          (Kota et al 2005).        -  Augmenting protein synthesis through activation of the mTOR-p70s6k pathway (Di Girolamo          et al 2014).      Supplementation with fish oil in older males and females:        -  Increases whole muscle phospholipid profile of EPA and DHA (Smith et al 2011).        -  Increases lean body mass (LBM), RMR, and fatty acid oxidation (Logan et al unpublished)        -  Decreases carbohydrate oxidation (Logan et al unplubished). Skeletal muscle (SM)          accounts for 20-30% of RMR (Zurlo et al 1990, Manini 2010), therefore it is tempting to          speculate that these changes may occur by some of the mechanisms described earlier, with          skeletal muscle being an important contributor.      To date there are no studies that have examined the effect of n-3 supplementation (3g/day)*     on plasma membrane fatty acid composition, RMR and substrate oxidation, and the possible     mechanisms behind it.      Therefore the purpose of this study is to determine whether in older adults (female and     male), supplementation with n-3 alters:        1. RMR and fatty acid oxidation.        2. Membrane composition of whole muscle and sarcolemma.        3. Content of skeletal muscle membrane fatty acid transport proteins.        4. Dose response of NaKATPase and SERCA efficiency        5. Content of mitochondrial proteins        6. Expression and content of PPARs and proteins involved in translocation of FA          transporters (AMPK, ERK1/2, CamKII).        7. Phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286).        8. Proteomic profile of skeletal muscle.        9. Body composition   "
72376|NCT02338388|"     The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy     closure technique.   "
72377|NCT02338375|"     The purpose of this study is to evaluate the safety and efficacy of adding allogenic     umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of     arthroscopic curettage and microfracture for osteochondral lesion of talus.   "
72378|NCT02338362|"     The purpose of this study is to determine whether a commonly prescribed orally inhaled     corticosteroid treatment will induce a clinically meaningful elevation in intraocular     pressure, when administered to patients with ocular hypertension (OHT) or open-angle glaucoma     (OAG). Based on the response to high-dose corticosteroids, this patient group is more likely     than the normal population to demonstrate this adverse effect.   "
72379|NCT02338349|"     The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of     RAD1901 in patients with advanced ER+, HER2-negative breast cancer.   "
72382|NCT02338310|"     To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI)     followed by standard adjuvant therapy improves outcome compared with standard adjuvant     therapy alone in postmenopausal women with hormone receptor positive breast cancer.      To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC)     in the excised cancer around 2 weeks after starting AI therapy will predict for time to     recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67     value.      To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts     for long-term outcome in postmenopausal women with hormone receptor positive breast cancer     better than at diagnosis.   "
72383|NCT02338297|"     Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients     with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate     portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in     poor Lipiodol deposition in the tumor, causing liver ischemia.      Occlusion of APS is a vital and initial step for the following embolization of tumor.     Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with     hepatocellular carcinoma (HCC).      The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in     the procedure of TACE, and to analyze the prognostic factors for survival in this kind of     patients.   "
72384|NCT02338284|"     Patients admitted to the ICU may have delayed awakening after their critical illness has     resolved. Though most either are due to metabolic causes or delayed elimination of sedative     medications, more serious pathologies such as intracranial hemorrhage, ischemic stroke, and     vasogenic edema may also be the cause of coma. These pathologies all result in increases in     intracranial pressure (ICP) with cerebral edema. Identifying elevated intracranial pressure     elevations have so far, relied on invasive monitoring techniques requiring placement of an     intracranial or intraventricular catheter.      The optic nerve sheath diameter (ONSD) has been described as a highly sensitive (88-94%) and     specific (85% - 94%) noninvasive technique of identifying increased intracranial pressures in     patients with brain trauma, intracranial bleeding or stroke[1-4]. This method requires     placement of an ultrasound probe on the patient's closed eyelid and then a direct measurement     of the diameter of the optic nerve sheath at a pre-specified distance from the globe. A value     greater than 58 mm has been shown to correlate significantly with an increased ICP (> 20 cm     H20); r = 0.71, p<0.001 [5].      The investigators hypothesize that bedside ultrasound measurement of the ONSD is a simple     screening test for increased intracranial pressure and can be used to rapidly and efficiently     identify patients in the ICU who have coma due to an increase in intracranial pressure. The     investigators propose to carry out an observational trial to determine the predictive ability     of the Optic Nerve Sheath Diameter for cerebral edema/ increased intracranial pressure and to     compare it with the results of neuroimaging (CT and/or MRI).   "
72391|NCT02338193|"     Women with a history of gestational diabetes (GDM) are at substantially increased risk of     type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more     likely to be overweight or obese. Moreover, weight gain after GDM is significantly associated     with T2DM, independent of baseline body weight. Weight gain, particularly increased central     adiposity after delivery, is strongly associated with deterioration of β-cell compensation     for insulin resistance. Taken together, our findings and other studies support increased     abdominal fat as the strongest factor associated with declining B-cell compensation for     insulin resistance in prior GDM women at high risk for T2DM. Dapagliflozin is a novel highly     selective SGLT2 inhibitor that improves glycemic control by reducing renal glucose     reabsorption leading to urinary glucose excretion. Its efficacy and safety has been studied     in multiple randomized controlled trials including an add-on to metformin compared with a     placebo. To the extent that glucotoxicity contributes to the demise in β-cell function in     subjects with impaired glucose, SGLT2 inhibitors also may prove useful in the treatment of     prediabetes. An additional secondary benefit of SGLT2 inhibition is the elimination of     calories in the form of glucose. The loss of glucose with attendant caloric loss contributes     to weight loss; in addition, improvements in β cell function have been seen. Weight loss seen     with SGLT2 inhibitors is similar to that seen with glucagon-like peptide 1 analogs, and may     be more acceptable because they are oral agents. A consistent finding in all dapagliflozin     studies has been a reduction in blood pressure. The investigators hypothesize that     combination dapagliflozin -metformin treatment over a 24-week period will have a greater     positive impact on body weight, anthropometric measurements and glycemic and cardiometabolic     parameters than dapagliflozin or metformin monotherapy in overweight/obese at-risk women with     a history of GDM.   "
72392|NCT02338180|"     It is of clinical importance to arrest the development of approximal caries at an early     stage. The potential for initial caries to develop into manifest lesions has motivated     studies on the use of sealants to arrest the progression of caries on both occlusal and     approximal tooth surfaces.      Therefore, the aim of the present study was to follow-up and examine after 3.5 years, the     efficacy of sealing caries-free or non-cavitated mesial surfaces of first permanent molars     abutting lesions on the distal surfaces of second primary molars. The null hypothesis tested     here was that preventive and therapeutic sealants do not prevent the development or slow the     progression of dental caries over a period of 3.5 years in comparison to non-sealed control     surfaces.   "
72393|NCT02338167|"     Among patients with breast cancer the subgroup of patients with metastases are considered the     group of patients with the worst prognosis. Not only with regard to therapy decisions but     also with regard to quality assured healthcare and health economics this entity of patients     remains a challenge.      Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor     entities and identification of patients, for whom the greatest therapy benefit and the least     side effects are expected.      However molecular assessment of the patient and the tumor in the metastatic situation is not     performed on a routine basis and in many cases tumor characteristics from the primary tumor     are considered reliable enough to make therapy decisions for the metastatic patients.     Although molecular reassessment of tumor characteristics from tumor material of the     metastasis is recommended in national guidelines, only a minority of patients is biopsied,     because of the invasiveness of the procedure, even though biopsy related complications are     reported to be rare.      With modern analytic methods from blood based biomaterial there seems to be an opportunity to     correlate blood based tumor assessments with actual characteristics of the tumor. These     include expression analysis, tumor mutation analysis, tumor gene copy number abberations and     others. One of the main aims of the PRAEGNANT study is therefore to establish an     infrastructure for the comprehensive analysis of tumor and metastatic molecular     characteristics of the patient and the tumor.      Furthermore the impact of health care related outcomes such as health economics novel     approaches for integration of patients in study conduct and health care awareness are study     aims of the PRAEGNANT study.   "
72394|NCT02338154|"     The purpose of this active post-market surveillance study is to confirm the safety and     effectiveness of the EDWARDS INTUITY Valve System in the study population.      The objective is to evaluate cardiac performance characteristics and adverse events rates     associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical     approach is either full or partial sternotomy or a right anterior thoracotomy.   "
72395|NCT02338141|"     This study will evaluate the effectiveness of portable colposcopy when compared to     conventional colposcopy (25x magnification of the cervix, the gold standard) and     Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted     low-resource method). Half the participants will be evaluated for cervical pathology by     portable colposcopy after VIA assessment, while the other half will be evaluated by     conventional colposcopy. This study also will use collected lab specimens for human     papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among     higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus     (HIV)-positive women.   "
72396|NCT02338128|"     The purpose of this study is to determine whether Febuxostat could protect cardiovascular     function of peritoneal dialysis patients by lowering serum uric acid.   "
72397|NCT02338115|"     The purpose of this prospective observational study is to understand the relationship between     paclitaxel exposure and development of peripheral neuropathy during treatment.   "
72398|NCT02338102|"     The purpose of this study is to learn whether nasal saline irrigation is beneficial to     patients undergoing radiation therapy for oropharyngeal cancer.   "
72399|NCT02338089|"     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide     and is caused most commonly by poor uterine muscle (myometrium) tone after delivery. The     first line agent used in the prevention and treatment of PPH is oxytocin.      Women who require augmentation of labor with intravenous oxytocin because of inadequate labor     progression have been shown to be at increased risk of PPH. Typically, for augmentation of     labor, oxytocin is used as a continuous infusion, with no consensus on the initial dose, its     increments or maximal limit. High concentration continuous oxytocin infusions are not without     theirs risks, which include hyperstimulation, fetal distress, as well as uterine rupture.      Studies have shown the clinical benefits of pulsatile oxytocin delivery for labor induction     and augmentation with regards to requirement of less total oxytocin, similar uterine     contractility and similar rates of caesarean delivery when used for labor induction and     augmentation. However, the rate of PPH as a primary outcome measure has not been     investigated. Therefore we currently do not know the effect of pulsatile oxytocin delivery on     the rate of PPH.      The investigators hypothesize that the effect of myometrial desensitization following     pulsatile oxytocin exposure would be lower when compared to continuous oxytocin exposure.     These results will help in establishing whether myometrial contractility and sensitivity to     oxytocin can be better preserved by delivery of pulsatile oxytocin, rather than continuous     oxytocin for labor induction and augmentation, and thereby result in less PPH.   "
72400|NCT02338076|"     Petrolatum is a very well-known emollient that has been used since the 1800's. Not only has     it been used to help with dry skin, but it is also marketed as a substance that protects     minor cuts and burns. In the past it was thought to be inferior to topical antibiotics in     infection prevention for cutaneous wounds. However, in 1996 a large, multicenter trial     including over 900 patients showed that petrolatum is as safe and effective as the topical     antibiotic, bacitracin in preventing infections for patients undergoing dermatological     surgery. In this trial, not only did the petrolatum group have similarly low rates of     infection, this group also reported no cases of contact dermatitis. Aside from being more     expensive than petrolatum, bacitracin and other topical antimicrobials (i.e. neomycin) have     been known as common culprits of contact dermatitis. In a study done by the North American     Contact Dermatitis Group between 2005-2006, 9.2 and 10% of the over 4,000 patients who were     patch tested had an allergic reaction to either bacitracin or neomycin, respectively. For the     above reasons, it is clear that petrolatum is an appealing alternative to topical antibiotics     for infection prevention in patients undergoing dermatological procedures. This study however     lacked any mechanistic analyses to provide molecular insight as to how petrolatum was     effective at infection prevention.      The aim of this research is to study the effect of petrolatum on innate immune reactions in     the skin. In particular, petrolatum's effect on various antimicrobial peptides after contact     with the skin for 3 days will be examined. This will be done through immunohistochemistry for     various cellular infiltrates as well as mRNA gene expression via RT-PCR analysis for     inflammatory and AMP genes. Tissue samples of petrolatum occluded skin will be compared to     both healthy skin and skin under occlusion alone as controls. These comparisons will isolate     the effect of the petrolatum on the skin.   "
72401|NCT02338063|"     The purpose of this study is to determine whether immersive virtual reality technology is an     effective intervention tool for HIV Prevention with adolescents.   "
72412|NCT02337920|"     Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need     complementary stenting of revascularization procedures within the 2 years after the primary     surgery because of a poor blood supply in their lower limb extremity. The Near infrared     spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and     provide information on the quality of the local oxygen supply. The aim of our observational     study is to correlate the intraoperative NIRS variations at the calf and the soles and the     one-year evolution of the arteritis.   "
72402|NCT02338050|"     This is a phase II, open-label, nonrandomized, prospective study to evaluate the activity,     safety, and feasibility of administration of moxetumomab pasudotox in the pre-allogeneic     hematopoietic cell transplantation (HCT) setting to patients with B-lineage Acute     Lymphoblastic Leukemia (ALL) who are in a morphologic complete remission and have     pre-transplant minimal residual disease (MRD) > 0.01% (detected by flow cytometry). The     primary objective of this study is to determine if treatment with moxetumomab pasudotox in     the MRD positive setting is able to lead to MRD negativity (< 0.01% by flow cytometry) or at     least a 1-log10 reduction in MRD prior to allogeneic HCT.   "
72403|NCT02338037|"     This pilot trial studies the brain concentration of eribulin mesylate in treating patients     with primary or metastatic brain tumors. Drugs used in chemotherapy, such as eribulin     mesylate, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Collecting small     samples of brain fluids may help determine how well eribulin mesylate concentrates into the     brain tumor.   "
72404|NCT02338024|"     This study proposes to assess whether a modified Antiretroviral Treatment Access Study     intervention, proved to be effective in the U.S. and based on the nurse case management     approach, can impact the enrollment in HIV care of recently detected HIV-positive patients in     specialized health care clinics in three regions in Ukraine, using the existing local     infrastructure. The proposed study addresses a significant public health issue of non-/late     enrollment of HIV-positive persons in HIV care and treatment.   "
72405|NCT02338011|"     1. Compare the effect and safety of gefitinib alone with gefitinib plus concomitant          WBRT(whole-brain radiotherapy ) in treatment of NSCLC patients harboring an EGFR          mutation with multiple BM.        2. Verify the failure pattern of NSCLC patients harboring an EGFR mutation with multiple          BM.        3. Explore the rescuable therapy after progression of disease.   "
72406|NCT02337998|"     Purpose: Quantify the relationship between brachial plexus deformations caused by backpack     carriage and upper extremity performance.      Significance of expected results:      The study will allow to quantify the effect of load carriage on both neural and vascular     function parameters.      Study plan The effect of nerve strain on neural function: based on the strains obtained for     each load from computational simulation, and from animal studies published in the literature,     the expected neural function, (e.g., motor and sensory) dysfunction will be estimated.      Following signing an informed consent form, 12 young adult subjects (18-35 years) will don a     military backpack loaded with 25-40 kg. Each volunteer will undergo the following test at     baseline, following 45 min exposure, and following 15 min of recovery:        1. Index finger microvascular flow will be measured by photoplethysmography (PPG).        2. Sensory measurement at the finger; Light touch threshold will be measured by mechanical          stimulation that will be applied using Von Frey Filaments of the Semmes-Weinstein          Monofilament (SWM) type.        3. Forearm thermal sensation threshold; As a measure of sensory function in the forearm,          cold and warm sensation thresholds will be measured with a computerized quantitative          thermal sensory device.           Immediately following the 45 min loading exposure, the fine motor function of the index          finger will be tested by the following procedures (in an unloaded condition):        4. Index finger motor function; Force application profile during a trigger press will be          measured using a force sensor located on a trigger of a dummy weapon simulator. Force          application rate, peak force, and press-to-press peak force variability will be measured          based on 10 trigger presses.        5. Accuracy of force application; Will be evaluated by the simulated shot accuracy,          horizontal displacement (X) and vertical displacement (Y).        6. Subjective parameters; in all time points, the volunteers will be asked to rate their          level of pain sensation intensity (VAS sensory) and degree of unpleasantness (VAS          affective) in the shoulders and other load bearing sites, as well as ratings of          perceived exertion (RPE). All subjective parameters will be assessed using visual          analogue scales.   "
72407|NCT02337985|"     This pilot clinical trial studies gene therapy following combination chemotherapy in treating     patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma.     Placing genes that have been shown in the laboratory to inhibit the growth and spread of the     immunodeficiency virus (HIV) into the patient's peripheral blood stem cells may improve the     body's ability to fight HIV. Drugs used in chemotherapy work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving gene therapy after combination chemotherapy may improve     the body's ability to fight HIV and AIDS-related non-Hodgkin lymphoma.   "
72408|NCT02337972|"     The aim of this study is to investigate the conjunctival bacterial flora and antibiotic     resistance patterns following serial intravitreal injections of anti-VEGF in diabetic     patients, using a povidone-iodine preparation without preinjection or postinjection topical     antibiotics.   "
72429|NCT02337699|"     25-SMI-2014 is a post market observational, questionnaire based study to assess the     effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin     pain. Within is also a nested feasibility study to assess the clinical utility of a     Quantitive Sensory Testing (QST) protocol in the management of the described study group.   "
72409|NCT02337959|"     The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus     3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the     currently marketed Carestream DRX-1 Detector. The results of this study will be included in a     Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US.     The study was designed in accordance with the FDA Guidance titled Guidance for the     Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on August 6, 1999.   "
72410|NCT02337946|"     The purpose of this study is to exploratorily examine efficacy and safety in the patients     with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of KRAS     wild-type who have been treated with 6 cycles (2 weeks/cycle) of first-line mFOLFOX6 +     panitumumab combination therapy and then assigned to two groups i.e., a group receiving     5-FU/LV + panitumumab combination therapy and a group receiving mFOLFOX6 + panitumumab     combination therapy.   "
72411|NCT02337933|"     The metabolic syndrome is characterized by the presence of overweight/obesity, insulin     resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which     together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus     type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower     ability of insulin to metabolize glucose, key in the physiopathogeny of disease process.      In the search for a pharmacological agent that can attend more components of the metabolic     syndrome and above all improve insulin sensitivity to effectively prevent the development of     CVD and DM2, ursolic acid is a promising compound.      Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some     fruits like apple peel, and plants such as rosemary. There is scientific evidence of     important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of     lipids and glucose, as well as on the body weight and metabolic parameters. However, the     results are not clear and the mechanisms are not fully elucidados.      The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity     and metabolic syndrome.   "
72413|NCT02337907|"     The study is designed to compare the effects of BI 409306 compared to placebo in patients     with cognitive impairment due to Alzheimer's Disease   "
72415|NCT02337881|"     The aim of this study is to assess whether or not the emergency tocolytic effect of combined     nifedipine and sildenafil citrate will have a superior effect over nifedipine alone in terms     of inhibiting eminent preterm labor and improving perinatal outcomes.   "
72416|NCT02337868|"     This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose     escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine     given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults > /=18 and < 50 years of     age. The primary objective is to assess the safety, reactogenicity, and tolerability of the     HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29     at a dose of 1 mcg or a dose of 4 mcg.   "
72417|NCT02337855|"     This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study     will recruit 72 healthy adult males and non-pregnant females from a single clinical center to     test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel®     plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The primary objective is to     assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug,     or 100ug) with or without GLA-AF vaccine given as three doses administered on Days 1, 57, and     113.   "
72418|NCT02337842|"     This is phase I, double blind, placebo-controlled safety and infectivity study of     experimental human Norovirus genogroup GII.4 administered to healthy adults 18-49 years of     age. Subjects susceptible to the human norovirus GII.4 challenge strain. The challenge study     will be conducted in 2-3 cohorts of approximately 20 subjects each.Subjects will remain in     the inpatient facility for at least four days following challenge and assessed daily for     clinical and virologic evidence of norovirus infection. The primary objectives are to     evaluate the safety and reactogenicity of the norovirus GII.4 (CIN-1; 031693) challenge stock     and to determine a safe and optimal challenge dose of Norovirus GII.4 Challenge Stock     norovirus to achieve illness in > /=50% of subjects. Illness is defined as: diarrhea (>3     loose or liquid stools or >300 gm of loose or liquid stool /24h), and/or vomiting during the     inpatient period, in a participant with evidence of infection.   "
72419|NCT02337829|"     This study is to determine the response to acalabrutinib in patients with chronic lymphocytic     leukemia (CLL) or small lymphocytic lymphoma (SLL).   "
72420|NCT02337816|"     Endometriosis is one of the most common benign gynecological, affecting about 10% of     premenopausal women. The pathophysiology of this disease is still not completely clear.     Despite its prevalence, there is no blood test available for the diagnosis of endometriosis     and the average delay time to diagnosis is 9.4 years.      Metabolomics is a scientific discipline that studies changes in metabolites related to the     pathophysiology of the disease.      Aim of the study is to identify an alteration in the expression of the metabolites in women     with endometriosis   "
72421|NCT02337803|"     The study will aim to determine the effectiveness of a strength training program using     resistance bands to increase strength in adults ≥65 years old   "
72422|NCT02337790|"     This study is designed to validate the use of the CoVa Monitoring System in subjects with     implanted devices.   "
72423|NCT02337777|"     The purpose of this study is to study the diagnostic efficiency of functional magnetic     resonance imaging in Abdominal and Pelvic Diseases.   "
72424|NCT02337764|"     The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with     levodopa in Japanese participants with Parkinson's disease.   "
72425|NCT02337751|"     The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in     Japanese participants with early Parkinson's disease.   "
72426|NCT02337738|"     The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1     mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with     wearing-off phenomenon.   "
72427|NCT02337725|"     The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day)     administered to Japanese patients with early Parkinson's disease.   "
72428|NCT02337712|"     This Phase II randomized study is to determine whether once-daily simultaneous modulated     accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for     patients with limited-stage small-cell lung cancer (LD-SCLC).   "
72431|NCT02337673|"     The purpose of this study is to determine whether Electrical Impedance Tomography can be used     as sensitive and specific predictor in the detection of postoperative pulmonary complications     (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion,     pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia,     spasms and obstructions of the airway) in patients undergoing epigastric surgery.   "
72432|NCT02337660|"     The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is     associated with hepatic glucagon resistance and hyperglucagonemia.   "
72433|NCT02337647|"     The purpose of the research study is to evaluate how well the Distortion Correction Data     Collection (DCDC) App works. The DCDC App is an experimental software application that is     being developed at the University of Nebraska Omaha. The DCDC app will map and draw the     visual distortions of patients with Age-related Macular degeneration.   "
72434|NCT02337634|"     The goal of the proposed study is to evaluate the efficacy and safety of silymarin in     individuals with gambling disorder. The hypothesis to be tested is that silymarin will be     more effective and well tolerated in subjects with gambling disorder compared to placebo. The     proposed study will provide needed data on the treatment of a disabling disorder that     currently lacks a clearly effective treatment.   "
72504|NCT02336724|"     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and     Flt3. Phase I study has shown that the toxicity is manageable.      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in     patients with advanced or metastatic gastrointestinal stromal tumor who failed from imatinib     therapy.   "
72435|NCT02337621|"     Recovery following major surgical procedures can be influenced by both physical (optimization     of cardiopulmonary function, pain control, activity) and psychological factors. Physical     activity recommendations for post-operative patients is difficult, in part because little is     known about the short- and long-term benefits of exercise and mobility on post-operative pain     and return to normal functioning.   "
72436|NCT02337608|"     -  Approximately 60 patients suffering from moderate to severe ulcerative colitis will be          evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or          matching placebo once daily for 12 weeks in addition to their stable background          treatment.        -  During the course of the study, patients will also be examined for any side effects that          may occur (safety and tolerability), and the amount of GLPG1205 present in the blood          (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of          action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will          be determined.   "
72437|NCT02337595|"     The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early     post-transplant is a safe way to improve immunity to common infections in recipients of     TCR-alpha/beta depleted hematopoietic stem cell grafts.   "
72438|NCT02337582|"     A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to     evaluate the effects of an opportunistic (hospital-based) screening program (intervention)     vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or     control arm (N=13). At intervention clinics general practitioners were instructed to perform     clinical breast examination (CBE) on all women aged 50-69 years attending clinics for     non-breast health related issues, and to refer them for mammographic screening. Physicians     from control clinics were not specifically instructed to perform breast-screening or refer     women for mammography, but could do so if they thought it appropriate ('usual care'). Women     were followed for 2 years post-randomization.   "
72439|NCT02337569|"     The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with     Zinc Deficiency.   "
72440|NCT02337556|"     To compare the nutritional effect on blood glucose of two commercially available enteral     diets in overweight or obese patients in the Intensive Care Unit.   "
72441|NCT02337543|"     This study is a double blind, placebo controlled, ascending single and multiple oral dose     study conducted in two parts, aimed at determining the safety and tolerability of single and     multiple oral doses of NEO6860 in healthy subjects.      Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and     gender.      The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain     methods.      Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an     ascending multiple dose, with 2 dose levels.   "
72442|NCT02337530|"     The purpose of this study is to find out what effects a new drug, selumetinib, has on lung     cancer when receiving standard chemotherapy with pemetrexed and platinum-based chemotherapy.   "
72443|NCT02337517|"     This pilot clinical trial studies how well vismodegib works in treating patients with chronic     graft-versus-host disease that did not respond to previous steroid treatment. Chronic     graft-versus-host disease can cause a build-up of scar tissue under the skin and lead to     symptoms such as sclerodermatous skin changes, dry mouth, dry eye, narrowing of the     esophagus, or vaginal graft-versus-host disease. Vismodegib may work against the build-up of     scar tissue and be a better treatment for chronic graft-versus-host disease caused by a     hematopoietic stem cell transplant.   "
72454|NCT02337374|"     Purpose The aim of this study is to investigate the contribution of preoperative urodynamics     to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and     easily accessible tools Methods Women with stress urinary incontinence and who desired     surgical correction of their incontinence were included in the study. The selection of the     procedure was according to an algorithm used in an institution developed by a chief of     urogynecology department who had 25 years of urogynecology experience. Urodynamic and     baseline factors that may be associated with surgery failure were analyzed in MUS failure.   "
72456|NCT02337348|"     Coronary artery intervention with stents is a routine procedure with several clinical     indications. A stentfailure, ie stentrestenosis and/or stentthrombosis will occur in some     patients. Several different mechanisms have been suggested. Stentfailure may be caused by     mechanical properties of the stent. This may be secondary to suboptimal stentimplantation, ie     over/undersizing or acquired ie malapposition or stentfracture. These stentproperties may be     difficult to identify with conventional coronary angiography due to low image resolution. The     hypothesis of the study is that high resolution imaging with optical coherence tomography     (oct) will improve diagnosis and enable a more specific or tailored treatment with a     subsequent reduction in later stentfailure.   "
72444|NCT02337504|"     Tremendous efforts and resources have been expended by the global community to ensure that     antiretroviral therapy (ART) is available and accessible to all that need it. Despite these,     less than a half of Human Immunodeficiency Virus (HIV)-infected patients requiring ART in     sub-Saharan Africa (SSA) are receiving it. Some of the most significant barriers to attaining     universal access to ART in this region include large distances that patients have to travel     to clinic, time spent in accessing care and a significant shortage of human resources. In     order to address these challenges the World Health Organization (WHO) advocates alternative     care models especially those that incorporate task-shifting to lower cadre health care     workers and lay persons. Unfortunately, few such alternative care models have been identified     and very little data exist on their long-term outcomes.      With this project we will develop and assess an alternative care model that is established on     the platform of a HIV-infected peer-group (ART Co-op) and facilitated by community health     workers (CHW's). This model of care is intended to decentralize ART services and bring them     closer to the patients. Specifically, we will:        1. Develop an acceptable and sustainable model for extending HIV care and treatment into          the community.        2. Perform a pilot study comparing the outcomes of patients enrolled in the ART Co-ops          program to those receiving standard of care.        3. Determine the cost savings and cost effectiveness of ART Co-ops.   "
72445|NCT02337491|"     In this research study, the investigators are looking to determine the effectiveness of     Pembrolizumab (MK-3475) when given with bevacizumab or when given alone for the treatment of     recurrent glioblastoma multiforme (GBM). This study will also test the safety and     tolerability of Pembrolizumab (MK-3475) when given alone or with bevacizumab.   "
72446|NCT02337478|"     This pilot phase II trial studies how well vincristine sulfate liposome works in treating     patients with acute myeloid leukemia that has returned after a period of improvement or has     not responded to previous treatment. Drugs used in chemotherapy, such as vincristine sulfate     liposome, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Liposomal     encapsulation prolongs bioavailability (proportion of drug that enters the circulation when     introduced into the body) of vincristine sulfate, and may increase its delivery to cancer     cells with fewer side effects.   "
72447|NCT02337465|"     This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and     ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or     pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors to     create a 3-dimensional picture of the tumor may help in planning radiation therapy and may     result in more tumor cells being killed.   "
72505|NCT02336711|"     Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose     Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.   "
72448|NCT02337452|"     Objectives:      To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG).      The long-term goals of this program are expected to include, but are not limited to the     following:        1. To enable families with inherited cancer susceptibility and/or at increased familial          risk of cancer to provide personal and family history of neoplasia through a convenient          and self-directed program.        2. To enable communication of possible inherited cancer susceptibility with and among          family members through the web-based portal.        3. To facilitate genetic testing, screening and prevention strategies in those at risk.        4. Establish high-risk cohort for optional participation in research and clinical trials.   "
72449|NCT02337439|"     In this study, participants with schizophrenia and schizoaffective are given computer     exercises to complete. The goals of the study are to determine whether: 1) any of the     computer exercises can improve information processing problems in schizophrenia, 2)     improvements in information processing are related to other cognitive improvements, and 3)     there are changes in brain activity associated with using the computer exercises.      The study will involve clinical interviews, cognitive tests, and frequent computerized     cognitive training over the course of 2 months. Some participants will also have     electroencephalography, a non-invasive test that measures brain activity, to determine     whether there are changes in brain activity with the computer training.   "
72450|NCT02337426|"     This phase 1 trial studies the side effects and best dose of dimethyl fumarate when given     together with temozolomide and radiation therapy(RT) in treating patients with newly     diagnosed glioblastoma multiforme (GBM). Dimethyl fumarate may help radiation therapy work     better by making tumor cells more sensitive to the radiation therapy. Drugs used in     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.     Giving dimethyl fumarate with temozolomide and radiation therapy may work better in treating     glioblastoma multiforme.   "
72451|NCT02337413|"     Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal     enuresis (bed wetting at night). This study aims to explore if treatment of patients without     overt constipation (As defined by the ROME III criteria) will also respond to stool softening     and GI behavioral therapy with reduction of their urinary tract symptoms when added to     standard urotherapy.   "
72452|NCT02337400|"     The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for     ambulant patients in a three-armed study design. Study participants will be randomized to one     of the following three study groups: experimental group: 5-week lasting cognitive behavioral     reduction program (smoke_less); active comparator: 15 minutes counseling interview; waiting     group: no intervention.      The three follow-up measures take place after the reduction program in week 6, 17 an 29.     After the finalisation of the last follow-up, participants from the active comparator and     waiting group get the chance to take part at the smoking reduction program at no charge.   "
72453|NCT02337387|"     The purpose of this study is to evaluate the tolerability of two different formulations of     blosozumab in women who have reached menopause.      This study will last approximately 12 weeks for each participant, not including screening.     Screening is required within 28 days prior to starting the study.   "
72457|NCT02337335|"     Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron     adminsitration in hemodialysis patients.   "
72458|NCT02337322|"     There are few randomized clinical trials in advanced HIV patients. This is a multicenter,     randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological     reconstitution and the virological efficacy and safety of 2 different combinations of     antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either     dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1     infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median     increase in CD4+ T-cell count at 48 weeks after starting HAART.   "
72459|NCT02337309|"     SF1126 is a novel inhibitor of PI3 kinase and mTOR that includes an active moiety (consisting     of LY294002) linked to an RGDS tetrapeptide that targets the active agent to integrin     expressing tissues. In this first pediatric phase 1 trial of SF1126, dose escalation will     follow a 3+3 dose escalation design. Once a recommended phase 2 pediatric dose is identified,     an expansion cohort of 10 patients with tumors with MYCN amplification, Mycn expression, or     Myc expression will be treated.   "
72506|NCT02336698|"     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of     fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of     osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.   "
72460|NCT02337296|"     This study includes a novel intervention entitled ADHERE, which includes one     semi-structured 30-minute face-to-face session and three 10-minute weekly phone sessions over     4 weeks, administered by an advanced practice nurse (APRN) to promote management of symptoms     and adherence in patients prescribed oral anti-cancer agents. Innovations in cancer treatment     are changing the treatment delivery landscape. It is projected that by 2015, 25% of treatment     will be delivered in pill form. This shift in the treatment paradigm places greater     responsibility on patients. However, patients with cancer are known to miss as much as     one-third of the prescribed doses of oral agents required for treatment of their disease.     Barriers to oral agent adherence include symptom severity, low self-efficacy, depressive     symptoms, lack of motivation, or beliefs that the medicine will not help, age, and regimen     complexity. The therapeutic outcome for those taking oral agents depends heavily on the     ability of patients to adhere to the prescribed regimen. Thus, a critical need exists to test     interventions that promote adherence and symptom management in patients taking oral agents.      ADHERE provides systematic patient education (PE) with the investigators evidence-based     Medication Management and Symptom Management Toolkit (Toolkit). This is combined with brief     cognitive behavioral therapy (CBT) to focus thoughts and beliefs to influence action; and     motivational interviewing (MI) to elicit reasons from patients to take action. The National     Cancer Institute (NCI), American Society of Clinical Oncology (ASCO), and Oncology Nursing     Society (ONS) have made adherence to oral agents a priority. Thus, the investigators are     testing ADHERE's impact on symptom severity and adherence to the oral agent regimen and     determining the acceptability and feasibility of the intervention among patients with cancer.   "
72461|NCT02337283|"     The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of     multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and     elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI     425809 given in the morning and in the evening.   "
72462|NCT02337270|"     This is a phase 1 study, in healthy volunteers who have previously been immunized with     bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in     the blood and lungs following the administration by aerosol of a new experimental     adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A.   "
72463|NCT02337257|"     Poor vitamin D status is very common in African Americans. Periodontitis (gum disease) are     shown to be related to theincreased risk of cardiometabolic diseases. Vitamin D is freely     available and cheap supplement that has shown beneficialeffect in the immune system     regulation and maintenance of the cardiovascular health. In this study The investigators     hypothesize thatvitamin D supplementation for 16 weeks in African Americans with     periodontitis will result in clinical improvement in theirgum health as well as their     cardiometabolic risk profile   "
72465|NCT02337231|"     A randomized, controlled, cross-over clinical trial of borage oil vs soybean oil to determine     whether the metabolism and/or impact of medium chain-polyunsaturated fatty acids (MC-PUFAs)     in botanical oil supplements are changed in relationship to specific genotypes in a SNP     (rs174537) strongly associated with FADS1 activity and PUFA metabolism.   "
72466|NCT02337218|"     This is a double‐blind randomized clinical trial. Both patients and the podiatrist that will     evaluate and monitor study patients will be blinded to electrical stimulation application.     The manufacturer of the units will be asked to not inform which patient received which unit.     Each unit will be coded with a unique identification number, and the manufacturer units     revealed their status, placebo or electric stimulation, only at the end of data collection     for the last patient. Subsequently, the investigators could match the status of the     identification numbers with the corresponding units to start analyzing the data. Patients     that receive an activated electrical stimulation unit will receive a standard dose of 50     volts as described above.      The investigator will enroll a cohort of 80 diabetes (type II) patients with peripheral     neuropathy (see section 6 for sample size justification). The diagnosis of diabetes mellitus     will be based on World Health Organization criteria.(World‐Health‐Organization 1999). The     inclusion and exclusion criteria are described in table III. The clinical assessments are     described in table IV. The investigator will discuss the study design, duration, and its     risks with potential subjects asked to participate. The participant will be provided with a     consent form to read at their leisure. The investigator will be available to answer questions     or provide more explanation as requested by potential participants and their family.   "
72467|NCT02337205|"     This is a phase 1 study to access the safety and tolerability of KX2-391 ointment in subjects     who have Actinic Keratosis. This study will also access the amount of KX2-391 drug that     enters the blood stream through dermal application of the ointment.   "
72468|NCT02337192|"     We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral     decontamination agent. It was also shown that SDS surfactant improves the antibacterial     action of APDT when using Curcumin as the photosensitizer. The decontamination levels     obtained with APDT are comparable with the levels observed with the use of Chlorhexidine. The     clinical relevancy is the control of oral microbial load which will improve the patients'     quality of life and will decrease the possibility of cross contamination in the dental     office.   "
72469|NCT02337179|"     The purpose of this study is to determine the feasibility of introducing voluntary medical     male circumcision as a form of HIV prevention in high HIV prevalence areas in the Dominican     Republic.   "
72492|NCT02336880|"     This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness     of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of     cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The     control group will receive care-as-usual.   "
72470|NCT02337166|"     BACKGROUND: Periodontal disease is an infection that results in progressive loss of dental     support, which may lead to tooth loss.. The goal of the present study was to evaluate if     recombinant human Fibroblast Growth Factor type 2 (rhFGF-2) applied in periodontal intrabony     defects in a hyaluronic acid (HA) carrier would enhance the clinical paramenters of     regeneration of the periodontal attachment apparatus and the long-term maintenance of the     results obtained. METHODS: Thirty adult patients were evaluated. Initial treatment consisted     in plaque control measures executed previously to the experimental phase. Two intra-bony     defects in each patient were ramdomly allocated for each of the treatment methods employed.     Control group (n=30) were treated by open debridement with the papilla preservation flaps,     while the text group (n=30) also received a topical application of rhFGF-2/HA in the     intrabony defect. The parameters evaluated were, probing depth (PD), gingival recession     (REC), probing attachment level (PAL) and probing bone level (PBL). Clinical measurements     obtained at baseline and 1, 5 and 10 years after the surgical procedure were compared.   "
72472|NCT02337140|"     Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change     in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this     intervention may induce heavy conduction disorder due to the proximity of the aortic annulus     and the conduction pathways. So far, there is no clear recommandation for clinical management     of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple     comorbidity factors observed in these patients. As described in conventional aortic valve     surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in     the first days. This is the reason underlying the systematic implantation of epicardial     electrodes. Such temporary back-up pacing is not possible in TAVI patients.      The primary end-point of this study is to confirm that standard criterion for pacing are     reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic     electrophysiological study (EPS).      In TAVI patients, indications for pacing were persistent high-degree atrioventricular block     (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours     after the procedure.      After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will     be realized in patients without pacemaker and compared to data obtained from the devices in     pacemaker-implanted patients (% of ventricular pacing > 1% ; presence of more than 1 AVB     episod).   "
72473|NCT02337127|"     Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic     hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg     seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months     apart (primary treatment endpoint). Stopping treatment can be considered if undetectable     HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative     patients. However, oral antiviral drugs currently approved for the treatment of CHB have     relatively limited sustained long-term efficacy and a large proportion of patients will     suffer from HBV recurrence after stopping treatment.   "
72474|NCT02337114|"     Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe     Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression,     anxiety and low self awareness. A key factor in recovery is adjustment to the effects of     injury. Psychological intervention may facilitate this change; however what works is unclear.     ACT seeks to improve psychological flexibility; the ability to be present with difficult     thoughts and emotions, rather than fighting them, and to accept ourselves as we are, not what     we believe we should be. Current research is limited, but what is published suggests it may     be useful for this group.      Due to the limited research this pilot study aims to conduct preliminary analysis on the     acceptability and feasibility of ACT for people with sTBI whilst also examining the     suitability of the study protocol in order to make recommendations for future studies.     Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be     recruited, one of which will serve as the intervention centre.      Clients in the intervention group will be asked to complete questionnaires a week before and     after participation in the 6 week ACT programme. Clients in the comparison group will be     asked to complete questionnaires a week before and after receiving 6 weeks of treatment as     usual (TAU). The treatment group will also receive TAU. All participants will be invited to     participate in a focus group at the end of this 8 week period to discuss their involvement in     the study.      Staff will be asked to complete a parallel version of one of the client questionnaires within     a similar timeframe. In addition staff at the intervention centre will be invited to attend a     focus group and complete an additional questionnaire after the eight week period.   "
72475|NCT02337101|"     Background:      Five - 15 % of patients with concussion continue to experience impairing physical, cognitive     and emotional symptoms longer than 3 months post-injury. Currently, no standardised treatment     is available for patients with persistent post-concussional symptoms (PCS) and systematic     treatment studies remain limited.      Aim:        1. to develop an early intervention programme based on principles from          cognitive-behavioural therapy and graded exercise for young patients with PCS lasting          more than 3 months, and        2. to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial.      Methods:      Patients aged 15 - 30 years diagnosed with concussion at hospitals in Central Denmark Region     will be screened for persistent symptoms two months post-injury. Those with impairing     symptoms will be invited to participate in a randomised controlled trial comparing the early     intervention programme with enhanced usual care. We expect to include 120 patients from     2015-2016. Treatment will be interdisciplinary and will begin approximately 3 - 5 months     after concussion. All patients will complete self-report measures at baseline and 3, 6 and 15     months after randomisation. The primary outcome is severity of PCS.   "
72476|NCT02337088|"     The purpose of this study is to determine if there is a difference in neonatal outcomes with     delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be     intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.   "
72490|NCT02336906|"     Constipation treatment has been found to ameliorate symptoms in some patients with lower     urinary tract dysfunction (including day time or combined day time/night time urinary     incontinence). This study aims to explore if treatment of patients without overt constipation     (As defined by the ROME III criteria) will also respond to anti-constipation treatment with     reduction of their urinary tract symptoms. Assessment of severity and response of lower     urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.   "
72477|NCT02337075|"     Being physically active is important for everyone's health, but it is often challenging for     people to start and sustain an activity routine. The investigators will develop and pilot     test the PATH (PAthway To Health) program with Indigenous communities served by the Kwakiutl     District Council (KDC) Health on North Vancouver Island. The project idea was conceived     through a partnership between the communities and University of British Columbia health     researchers. The PATH program will include an education sessions on how to be active,     physical activity coaching by community health workers, and the use of Fitbit Flex (a     wearable activity tracker). The investigators will develop a culturally appropriate online     application to pair with Fitbit, which will provide instant feedback to individuals about     their activity level. 60 community members will be recruited to test the PATH program. Their     physical activity level, health status and use of activity resources at KDC Health Centres     will be assessed.   "
72478|NCT02337062|"     A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic     in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting     (PONV).   "
72507|NCT02336685|"     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of     fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate     to severe pain and functional impairment from knee or hip osteoarthritis that is not     adequately controlled by current pain therapy.   "
72479|NCT02337049|"     In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we     will conduct a 10-year follow-up study comparing 40 women with a history of early onset     preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history     of normotensive pregnancies.      Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital     1998-2008.      Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of     gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.   "
72480|NCT02337036|"     Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its     use is complicated by its narrow therapeutic index and variable pharmacokinetics. This study     is designed to assess the posology of tacrolimus in post-transplantation in the month after     liver transplantation to obtain a therapeutic target between 10-15 ng/mL and the impact of     biological and genetic factors on the pharmacokinetic parameters in paediatric liver     transplant recipients.   "
72481|NCT02337023|"     The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy     subjects.      These results will be compared with data obtained out of episode in patients with     Kleine-Levin syndrome (KLS).      The investigators want to determine if brain functional imaging and cognitive abnormalities     persist during asymptomatic period in a large series of patients with KLS, and to find     predictors of these abnormalities.   "
72482|NCT02337010|"     Patients who are scheduled for: elective oesophageal tumour resection, total gastrectomy,     pancreas resection, major vascular, total cystectomy will be recruited.To investigate effects     of central venous pressure (CVP) and central venous saturation (ScvO2) guided fluid     management on intraoperative haemodynamic parameters, volume and vasopressor requirement, and     postoperative organ function and postoperative inflammatory response.   "
72483|NCT02336997|"     The purpose of this study is to evaluating whether autologous grafted fat transplantation or     SVF transplantation is safe and/or effective to accelerating skin regeneration and soft     tissue expansion.   "
72484|NCT02336984|"     The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a     combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will     assess the safety and immunogenicity of the combination therapy. The target population is     women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive.     Participants will receive 6 vaccines along with 2 doses of trastuzumab.      This study began at the Abramson Cancer Center of the University of Pennsylvania and will     continue at H. Lee Moffitt Cancer Center and Research Institute.   "
72485|NCT02336971|"     This study seeks to enroll 76 couples in which one of the members is a combat-veteran with     PTSD. Each couple will be randomized into one of two cognitive-behavioral therapies developed     specifically as a treatment for PTSD—either Prolonged Exposure (PE) [1-4] or     Cognitive-Behavioral Couples Therapy (CBCT) [5-7]. Whereas, PE was developed as a one-on-one     therapy that focuses on treating the individual, CBCT for PTSD incorporates the partners into     therapy and seeks to directly address relationship functioning while treating the PTSD     symptomatology. Both partners in each couple will complete a battery of several assessments     measuring various aspects of psychological distress (e.g., depression, PTSD) and relationship     functioning at five time-points throughout the study. But, only the partners assigned to the     CBCT group will be involved in the actual therapy sessions. Analysis will be carried out to     identify whether any significant differences exist between PE and CBCT in treating PTSD and     improving relationship functioning.   "
72486|NCT02336958|"     For ultrasound guided intermediate cervical plexus block this randomized comparison is     testing the hypothesis, that an additional perivascular infiltration is associated with     increased block quality.   "
72487|NCT02336945|"     This is a multi-center, prospective, non-pivotal, single arm, non-significant risk evaluation     the Abbott Sensor Based Glucose Monitoring System - Pro across different stages of T2     diabetes management. This is a non-significant risk study.   "
72488|NCT02336932|"     The purpose of this study is to describe changes in vitamin D parameters before, during and     after a well-defined elective surgical trauma (knee arthroplasty) and to compare these     changes to other steroid hormones (testosterone and oestrogens). The hypothesis is that     profound changes in free and total vitamin D will occur as a result of changes between     intravascular vs extravascular protein compartments during surgical trauma.   "
72489|NCT02336919|"     Participants will be recruited during their hospitalization for either heart attack or     unstable angina and will be randomly assigned to either a text message program (Txt2Prevent)     or usual care. They will be texted for the first 60-days after discharge. Texts will include     topics regarding self-management and discharge protocols such as reminders to make an     appointment with their general practitioner or to refill medication prescriptions. After 60     days, the two groups will be compared for hospital readmission rates, quality of life,     medication adherence, and self-management.   "
72493|NCT02336867|"     Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common     and generally associated with pain, anal incontinence, impaired quality of life and work     incapacity. The therapeutic management of this disease has a double objective: heal the     suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000     in the normal population, with a difference in prevalence between men and women (1.23 per 10     000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et     al., 2012).      In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses'     anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an     abscess between the internal and external sphincters, which in turn can spread to other parts     of the perianal region. The infection can follow many directions from this point in the     intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal fistula     therefore has always an intraductal origin, cryptic, with a primary port at this level, and     the disregard of which causes the recurrence of the fistula; and usually a secondary port in     the skin.      Fistulas are usually divided into two groups. The first group contains fistulas called     simple, which are intersphincteric fistulas or trans-sphincteric involving only the lower     third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group     contains fistulas called complex. These are intersphincteric, trans-sphincteric, or even     suprasphincteric, extrasphincteric fistulas.      For many years, the treatment of choice was to open the fistula (fistulotomy), but this     procedure was associated with a risk of incontinence, the consequences could be potentially     devastating. Other surgical treatments include setons, fibrin glue, collagen plugs and     advancement flap technique to cover internal opening of the fistula. The success of these     therapies remains variable.      The advancement flap technique remains a strategy of choice in the treatment of anal fistulas     and particularly in the case of complex fistulas. The success rate of the advancement flap     technique remains variable across studies but a recent meta-analysis finds a success rate of     around 60%.      A new technique for closing anal fistula is currently in development with the use of a     closure clip nitinol (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life     Partners). This new technique has been validated in a porcine model of anal fistula, ensuring     the safety of the device. A first case was published in a patient with complex anal fistula     (high trans-sphincteric). After erosion fistula tract with a special brush, a nitinol clip     (OTSC® Proctology) was deposited on the internal opening of the fistula. Eight months after     surgery, the fistula was healed and the clip was removed by cutting with special pliers. This     technique is currently being broadcast and dozens of patients were treated with this clip     without any further scientific validation of the process.      To date, this innovative technique of the closure clip has not yet been assessed in a     randomized controlled trial. It is therefore essential to carry out a prospective evaluation     in order to determine the effectiveness and safety of this new device in the case of complex     anal fistulas.   "
72495|NCT02336841|"     The aim of this study is to test a novel guided self-help intervention for patients with     Anorexia Nervosa. The 6-week intervention includes the use of self-help materials (i.e. a     workbook and short video-clips) and weekly guidance from a peer mentor (i.e. a person     recovered from Anorexia Nervosa). Self-reports will be completed at baseline, end of 6 weeks,     and 6- and 12 months follow-up. Participants interested in taking part will be randomly     allocated to one of two groups.   "
72496|NCT02336828|"     This study is to validate the use of the modified early warning score (MEWS) in an adult     oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It is     expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading will     be associated with an increased risk of death or ICU admission, and should be regarded as a     MEWS Alarm. If MEWS is proof to be a reliable alternative tool, early diagnosis and     aggressive management of life-threatening complications in oncology patients, results in     dramatic improvements in overall survival rates.      This is a prospective, single centre, observational, cohort study. Objective of this study is     to investigate the ability of the Modified Early Warning Score (MEWS) to predict 7 day     mortality in adult clinical oncology ward patients.      The alternate hypothesis of this study is a significant difference in 7 day mortality between     adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a     MEWS alarm.      The null hypothesis is a no significant difference in 7 day mortality between adult oncology     ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.      The primary outcome measure in this study is the number of patients who die within 7 days of     a MEWS Alarm (7 day mortality).      The secondary outcome measure in this study is the number of patients admitted to ICU within     7 days of a MEWS Alarm.   "
72497|NCT02336815|"     This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus     dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with     penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).   "
72498|NCT02336802|"     Anxiety disorders are characterized by exaggerated levels of fear that are not proportional     to the actual level of threat. More specifically, anxiety patients have marked deficits in     the downregulation of fear reactions during situations of objective safety. Pre-clinical     research on Pavlovian fear conditioning and extinction has discovered that fear     downregulation stems from areas in the prefrontal cortex (the ventro-medial prefrontal     cortex, vmPFC) that recruit intercalated cells in the amygdala to inhibit its central     nucleus, which is responsible for a variety of behavioral expressions of fear (Milad & Quirk,     2012). Accordingly, functional magnetic resonance imaging studies (fMRI) revealed reduced     vmPFC activity coupled with increased fear reactions during situations of objective safety in     anxiety patients (Milad et al., 2009). Another core symptom of anxiety disorders, though much     less investigated, is the excessive avoidance of situations that trigger the fears. These     'safety behaviors' often interfere with daily life activities and valued goals in life, and     they are thought to perpetuate the exaggerated levels of fear by precluding opportunities to     learn that the feared situations are actually not dangerous. Surprisingly, experimental     research on avoidance behaviors in anxiety patients is virtually non-existent. This     experiment modifies the Pavlovian fear conditioning procedure to include avoidance, and     explores the behavioral and neural processes of this type of fear regulation in anxiety     patients (trans-diagnostically) and healthy individuals.   "
72499|NCT02336789|"     The investigators propose to transplant feces from thin, disease-free donors into obese     patients undergoing colonoscopy for screening for colorectal carcinoma.      The investigators will obtain feces from healthy donors with a BMI of between 21-24. The     investigators will perform colonoscopy on healthy patients with a BMI of 30-40 kg/m2 who have     a clear indication for a screening examination.      All patients will undergo a screening colonoscopy and will be allocated to receive either 250     ml of diluted fecal material prepared from a screened donor, or an equivalent volume of     normal saline (sham transplantation).      The patients will be reviewed at 1 3 6 and 12 months. At this time note will be made of their     weight, BMI and waist circumference. In addition note will be made of their fasting glucose     and lipid profile.   "
72500|NCT02336776|"     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney     function and in its most advanced stage is called chronic renal failure.      Although hemodialysis replace some kidney function, patients suffer some alterations     characterized by uremic syndrome typically expressed by: motor neuropathy and/or autonomic     neuropathy, cardiac or musculoskeletal myopathies, peripheral vascular changes, among others.     Thereby, the the adoption of physical exercise should be encouraged. However, it is known     that the ability to exercise the subject in hemodialysis is low and keeping in mind the     weakness of the muscular system in these individuals, the aim of this study is to assess the     effects of functional electrical stimulation (FES) on muscle architecture of patients with     chronic kidney disease hemodialysis.      For this the following assessments will be performed before and after stimulation:     ultrasonography to assess muscle architecture; six-minute walk test to functional capacity;     Kidney Disease and Quality of Life - Short Form questionnaire for quality of life; sit and     stand test for resistance of the lower limbs; dynamometric by load cell for muscle strength     of the lower limbs; flow-mediated dilatation to endothelial function; blood collection for     analysis of inflammatory markers and DNA damage.      The subjects will be randomized into two groups, FESG (functional electrical stimulation     group) and CG (control group). The first will receive the FES in the quadriceps muscle of     both thighs, for eight weeks, three times a week during hemodialysis session. While the     control group only will be evaluated and re-evaluated.      Expected results at the end of the protocol with FES are: increased quadriceps muscle     thickness; longest distance covered on the six-minute walk test; improved quality of life;     increase in resistance of the lower limbs; increased muscle strength of the lower limbs;     improved endothelial function; improved inflammatory status and DNA damage.   "
72501|NCT02336763|"     This clinical trial studies giving radiation therapy to the liver in patients with uveal     (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2 and     therefore more likely to have their disease spread from the eye to the liver. Radiation     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to the     liver may reduce the development of tumors in the liver and the overall risk of disease     recurrence.   "
72502|NCT02336750|"     Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in     Delayed Emesis Control and Appetite Improvement   "
72503|NCT02336737|"     The purpose of this pivotal study is to provide prospective evidence that the     SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node     localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB)     procedure and to summarize measures of product safety and performance.   "
73990|NCT02317276|"     The purpose of this study is to assess the differential expression of AD biomarkers in serum,     plasma, and skin biopsies from both lesional and non-lesional skin in moderate to severe AD     patients in the presence of TCS and after withdrawal from TCS.   "
72514|NCT02336594|"     This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and     pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative     bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets)     and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat     and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.   "
72515|NCT02336581|"     To test the effectiveness of Acceptance and Commitment Therapy (ACT) versus enhanced     Treatment as Usual (eTAU) delivered by hospital staff for inpatients with psychotic-spectrum     disorders.   "
72516|NCT02336568|"     Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the     hypothalamus - is a mediator stress regulation and improves social bonding. Recently, several     theoretical studies suggested that PTSD patients have abnormal functioning of the OT system.     According to these theories, dysfunction in the oxytocin system may modulate the     interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially     relieve these symptoms. In two current studies that were conducted in Rambam health care we     found that a single dose of intranasal OT reduces anxiety and irritability symptoms, and     enhances emotional empathy and compassion, in patients with PTSD. The main goal of this study     is to examine the effects of 21-days intranasal Oxytocin on clinical symptoms and social     function in these patients.   "
72517|NCT02336555|"     This study aims to determine whether MK-8291 is effective in reducing pain in participants     with post-herpetic neuralgia (PHN) with allodynia. The primary hypothesis is that when     compared to placebo, treatment with MK-8291 reduces the change from baseline in     participant-reported pain intensity by 1 on an 11-point numeric rating scale.   "
72518|NCT02336542|"     96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided     into different groups through a randomized, blind methods.Every subject inject intradermally     ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon)     detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate)     ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the     tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the     optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.   "
72519|NCT02336529|"     Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors     and nerve damage has been implicated as the cause of this neuropathic pain condition. Local     anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide     clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but     has never been attempted. The aims of this study is to examine clinical effect of ultrasound     guided blockades of the ICBN and tenderpoints of pain.   "
72520|NCT02336516|"     Post diarrheal hemolytic and uremic syndrome (D+HUS) is the first etiology of acute renal     failure in children less than 5 years old in France. Previous works highlighted a mortality     rate of 2 % and a prevalence of renal sequelae at one year after D+HUS onset in 25 % of     patients D+HUS is a consequence of a gastrointestinal infection with shiga toxin (Stx)     producing E.coli (STEC). The most frequent straight is E.coli O157H7. The sequence of STEC     induced HUS is now well known. Typically, digestive symptoms appear five days following STEC     ingestion. STEC colonize the intestinal mucosa, adhere to the enterocyte and cause a typical     attaching/effacing lesion and inflammation. Then, diarrhea and vomiting occurred. D+HUS     occurs in about 10% of patients and is a consequence of Stx systemic absorption. Indeed, Stx     are released in the gastrointestinal tract, then after transferred to the systemic     circulation. At the cellular level, Stx binds the globotriosylceramide (Gb3Cer) localized at     the surface of the endothelial and epithelial cells of target organs. Following binding to     Gb3Cer, the A subunits of Stx are internalized and trigger the activation of the apoptotic     program leading to cell death. In addition, Stx are also able to enhance the production and     the release of pro inflammatory factor (IL-1, TNFα, IL-6). Cytokines locally produced by     Stx-stimulated cells can amplify the inflammatory processes and the prothrombotic state     leading to the constitution of the microangiopathic lesions of HUS. To this day, management     of D+HUS involves supportive care mainly based on fluid management, dialysis and red blood     cells transfusions. Specific therapies used in D+HUS (plasma infusion, antithrombotic and     anti inflammatory agents) failed to improve the course of D+HUS. The use of antibiotics     remains not recommended while meta-analysis clearly showed that the use of bactericidal     antibiotics could worse the course of D+HUS. In vitro experimentations highlighted that some     classes of antibiotics like fluoroquinolones dramatically increase the production and the     release of Stx before bacterial lysis and worsen the outcome of D+HUS in animal models. By     contrast, azythromycin, a bacteriostatic antibiotic of the macrolides family blocking the     protein synthesis in bacteria, has a strong inhibitory effect on Stx production and release     by STEC as well as it inhibits the in vitro growth of STEC strains. In addition, azithromycin     is able to inhibit the Stx-induced production of inflammatory cytokines which are considered     to be essential for the development of D+HUS. Consistently the use of azithromycin in animal     models of D+HUS dramatically improved the survival rate. Preliminary data on humans with     D+HUS treated with azithromycin highlighted a lower prevalence of severe gastrointestinal     involvement than in control patients. All these data supported the hypothesis that     azithromycin should have a beneficial effect on D+HUS and should improve the short and long     term outcome and deserves to be formally demonstrated in human with D+HUS.   "
72521|NCT02336503|"     To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when     applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.   "
72522|NCT02336490|"     This randomized pilot study proposes to field-test key logistical aspects of studying an     intervention already available to patients on the pediatric ward, namely a discharge     medication delivery service, called Meds-in-Hand, which has been refined via a quality     improvement process, but not rigorously studied nor fully implemented.   "
72523|NCT02336477|"     Treatment strategies in non-dystrophic myotonias are based on selective case reports,     clinical experience and theoretical benefit. Presently, the most promising antimyotonic     medication is mexiletine (MEX) but its manufacturing was stopped. The proposed randomized,     double-blind, placebo-controlled, crossover trial is designed to:        1. study the safety and efficacy of mexiletine for the treatment of non-dystrophic          myotonias        2. validate electromyographic tests as a standardized outcome measure of myotonia        3. assess the reliability and validity of a new clinical rating scale for myotonia   "
72524|NCT02336464|"     Although pain has been extensively studied in ICU patients, only a few studies have focused     on dyspnea, which is experienced by 50% of mechanically ventilated patients. The purpose of     the present study is to determine whether dyspnea in intensive care unit patients is     associated with a higher length of stay in the ICU and a higher incidence of post traumatic     stress disorders.   "
72525|NCT02336451|"     This is a phase II, multi-center, open-label, five-arm study in which the efficacy and safety     of oral ceritinib treatment will be assessed in patients with NSCLC metastatic to the brain     and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis     ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including     positivity criteria). If documentation of ALK rearrangement as described above is not locally     available, a test to confirm ALK rearrangement must be performed by a Novartis designated     central laboratory. Patients must wait for the central laboratory result of the ALK     rearrangement status before initiating treatment with ceritinib.   "
72526|NCT02336438|"     One of the emerging complications of RNY gastric bypass surgery is mild to severe refractory/     recurrent postprandial hypoglycemia. This complication can lead to a significant reduction in     quality of life to severe disability. Unfortunately at this time there are no treatment     guidelines or proven therapeutic options for the treatment of this complication. One of the     proposed treatment options is the use of fiber supplements to help modify the absorption of     glucose, slow the food bolus transit time more toward normal and restore the postprandial     (after meal) glucose homeostasis. The investigators are proposing a pilot project for the use     of Glucomannan soluble fiber as a treatment option for postprandial hypoglycemia in this     cohort. This project will help the investigators to identify if Glucomannan soluble fiber can     be used as an effective dietary supplement to eliminate or reduce this condition   "
72527|NCT02336425|"     This study planned to assess the effect on the reduction in rate of severe asthma     exacerbations of different dose levels of QGE031 in asthma patients that are inadequately     controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid.     However, this study was terminated due to the efficacy results from an interim analysis (at     the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data     analyses were not performed for this study due to the early termination and the very limited     dataset (only 10 participants received study medication of the 440 participants planned).   "
72528|NCT02336412|"     Secondary preventative medications are prescribed to reduce the risk of recurrent stroke     following ischaemic stroke. However, continuation rates can be as low as 50% and are likely     to be multifactorial. One factor will be patients forgetting to take the medication or a     reduced appreciation of the importance of the medication as the time from the stroke passes.     Numerous approaches to improve persistence to secondary preventative medications have been     tried. One simple approach is use of mobile phone text messages as a reminder for patients to     take their medications. In this study, we will introduce an educational and motivational     strategy to inform patients about their medications and explore whether a reminder     intervention, using Short Message Service (SMS), improves adherence to antiplatelet drugs,     antihypertensive medications and lipid lowering drugs. We will also explore whether this     improves blood pressure and cholesterol levels in the first 3 months after stroke.   "
72529|NCT02336399|"     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of     cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be     the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and     the ultimate treatment goal in CHB. However, some patients achieved HBsAg loss would reverse     back to HBsAg positive, even occur HBV reactive. in this study, the viral and HBsAg response     in patients achieved HBsAg loss by interferon treatment will be observed for two years after     completed IFN treatment.   "
72530|NCT02336386|"     The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and     Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.   "
72531|NCT02336373|"     Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle     cell disease with typically higher hemoglobin and milder or later disease complications.     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This     can result in painful episodes, serious infections, and damage to body organs. One medication     used to treat sickle cell disease is hydroxyurea.      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with     sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest     syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients but     HbSC patients were not included in the large clinical trials used to test hydroxyurea in SCD,     so less is known about how HbSC patients respond to hydroxyurea.      The purpose of this research study is to see if hydroxyurea, a medication given to many     children with the most common type of sickle cell, those who are homozygous for the sickle     mutation (HbSS), helps children who have HbSC. The investigators will see if it helps by     giving a questionaire when the medication is started, and then every two months at a clinic     visit. The questionaire, called the Pediatric Quality of Life Inventory (PedsQL™) Sickle Cell     Disease Module version 3.0, measures quality of life. The investigators will also see how     hydroxyurea changes laboratory test numbers, and blood thickness.   "
72532|NCT02336360|"     This study will obtain data from urine in subjects administered 18F-AV-1451 in an     Avid-sponsored study to augment the calculation of radiation dosimetry estimates.   "
72533|NCT02336347|"     To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide     [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady     state.   "
72534|NCT02336334|"     Measuring and logging head positions of patients which underwent surgery with     gasendotamponades.   "
72535|NCT02336321|"     In this study, 6 volunteer participants with chronic spinal cord injury will be invited to     use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction     (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the     intention of the user to grasp objects of daily life. The BNCI system consists of a     lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a     computerized control system integrated into a wheelchair. Before, during and after use of the     BNCI system the volunteers will perform standardized assessments and complete questionnaires     to assess the functional and psychological effects of the exoskeleton. Functional outcomes     primarily focus on motor function in performing daily life actions while psychological     outcomes primarily focus on safety, reliability as well as predisposition and perceptions of     disability.   "
72544|NCT02336204|"     The increase of overweight and obesity in young Italian people, nowadays showed by several     epidemiological data, has been related to the misuse of alcohol and to a lack in nutritional     knowledge.      Thus the aim of our study was to investigate if different nutritional knowledge from could     affect body composition and drinking habits of a cohort of local young people.      104 healthy subjects (56 males and 54 females) were recruited using oral advertisements among     the students of 18-19 years-old belonging to the Istituto Agrario and the Istituto     alberghiero Raineri-Marcora of Piacenza. The subjects were asked to complete a questionnaire     on alcohol consumption and another one related to nutritional knowledge. Then anthropometric     data were measured: height, weight, waist and hips circumferences, waist-hips ratio and     skinfolds were evaluated for each subject and body fat mass was calculated.   "
72547|NCT02336165|"     This is an open-label, non-randomized, multicenter Phase 2 study of MEDI4736 with three     non-comparative cohorts:      Cohort A: 37 subjects with newly diagnosed unmethylated MGMT GBM will receive MEDI4736 every     2 weeks in combination with standard radiotherapy.      Cohort B: 30 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2     weeks as monotherapy.      Cohort B2: 32 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2     weeks + bevacizumab every 2 weeks (10 mg/kg).      Cohort B3: 32 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2     weeks + bevacizumab every 2 weeks (3 mg/kg).      Cohort C: 17 bevacizumab-refractory subjects with recurrent GBM will receive MEDI4736 every 2     weeks in combination with continued bevacizumab.   "
72548|NCT02336152|"     To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in     maintaining peri-operative body temperature as forced air warming, during open low-back     surgery of medium duration.   "
72549|NCT02336139|"     To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of     treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic     HCV infection and recent injection drug use.   "
72536|NCT02336308|"     Burn-related pain is severe and often difficult to manage. Healthcare workers struggle with     keeping burn patients comfortable, especially when these patients undergo dressing changes of     their burn wounds of their skin since these procedures often cause severe pain. Patients with     burn wounds frequently require high doses of opioids (narcotics) and calming (anxiolytic)     agents to the extent that clinicians must weigh the risks associated with these doses against     achieving adequate analgesia and comfort. The biggest risk is over-sedation to cause     breathing troubles. Inadequate pain control during these procedures heightens pain     perception, anxiety, and fear surrounding the experience and may lead to patients     experiencing additional psychological disorders like depression, acute stress disorder (ASD),     and post-traumatic stress disorder (PTSD). Therefore, therapeutic options for better     management of pain and anxiety during these procedures need to be identified.      This study will address whether the addition of ketamine during dressing changes improves     patients' pain control and comfort and whether this leads to favorable psychological     outcomes. The study is designed to compare ketamine with placebo when they are added to usual     care (opioids and anxiolytics) during dressing changes. The main outcomes of the study will     be the amount of opioid and anxiolytic agents each group receives during their procedure; the     presence of pain-related anxiety shortly after the procedures; blood markers of stress during     the procedures; and the presence of depression, anxiety and stress disorders prior to     discharge. This study will assess whether the early administration of ketamine reduces pain     and anxiety to prevent the need for high doses of opioids and anxiolytics. A total of 30     patients will be enrolled.   "
72537|NCT02336295|"     The study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for the     vegan population in Israel. The participants will complete the FFQ, and the data will be     verified by evaluating the participants energy expenditure (by measuring BMR, body     composition and daily activity) and conducting a 24-hour food interview.   "
72538|NCT02336282|"     A common and potentially debilitating late effect of childhood cancer treatment is     neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit     educational attainment, employment, and quality of life. Among the survivors of childhood     acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function     impairment has been shown as high as 58.8%, with moderate to severe impairment as high as     33.5%, and risk for impairment increased with time from diagnosis. Given the potential of     pervasive impact of neurocognitive impairment on daily life, interventions directed at     reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up     are needed. This study examines the potential feasibility and efficacy of a novel     intervention to improve executive function.      Primary Objectives:        -  To evaluate the feasibility of a home-based intervention using Transcranial Direct          Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL          participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).      Secondary Objectives:        -  To estimate the efficacy of a tDCS intervention paired with cognitive training.        -  To explore the short-term effect of tDCS on measures of executive function among adult          survivors of childhood ALL participating in the SJLIFE protocol   "
72539|NCT02336269|"     Primex's PGX assay is an in vitro, semi automated assay, intended for the determination of     certain genes involved in drug metabolism utilizing buccal swabs. Detection of certain     genotypes is used as an aid in the selection of appropriate medications based on the     individuals' specific genotype and should be used in conjunction with other clinical     information. The results from this tests constitutes one parameter in a multicriterion     medication selection process, encompassing both clinical and laboratory-based assessments.   "
72540|NCT02336256|"     Introduction: Any form of trauma, including surgery is known to result in oxidative stress.     Single incision laparoscopy is a step forward towards almost scarless surgery. It is also     expected to result in a lower degree of free radicals generation and faster normalization of     the organism's antioxidant capacity.      Aim: The aim of the study was to assess a number of plasma oxidative stress markers in     patients operated due to inguinal hernia using typical totally extra peritoneal (TEP) and     modified single incision laparoscopic surgery (SILS) methods.      Material and methods: Thirty-two consecutive patients with no acute disease and severe     chronic disorder, were qualified for inguinal hernia laparoscopic surgery. All were caucasian     males, aged 24-69 and they underwent one of two surgical approaches: totally extra-peritoneal     repair (TEP) and single incision laparoscopic surgery (SILS). TEP patients created Group 1     (n= 17) and SILS patients formed Group 2 (n= 17). Total antioxidant status (TAS) and     thiobarbituric acid-reacting substances (TBARS) were determined in three time points: before,     one day and four days after the laparoscopic surgery.   "
72541|NCT02336243|"     This study evaluates the effectiveness of maternal supplementation with Docosahexaenoic acid     (DHA) early in pregnancy to reduce the incidence of deep placentation disorders: preterm     birth, preterm labor, preterm premature rupture of membranes, preeclampsia and fetal growth     restriction. Half of the participants in early pregnancy will receive DHA 600 mg per day,     while the other half will receive placebo. Investigators will study also the ability of DHA     supplementation, early in pregnancy, to enhance invasion and transformation of spiral     arteries by trophoblast, as deep placentation indicators.   "
72542|NCT02336230|"     The study plans to treat at least 60 pediatric subjects, male and female, between the ages of     2 months and 17 years inclusive with acute Graft versus Host Disease (aGVHD) following     allogeneic hematopoietic stem cell transplant (HSCT) that has failed to respond to treatment     with systemic corticosteroid therapy. Subjects may have Grades C and D aGVHD involving the     skin, liver and/or gastrointestinal (GI) tract or Grade B aGVHD involving the liver and/or GI     tract, with or without concomitant skin disease.   "
72543|NCT02336217|"     The purpose of this pilot study is to determine the utility of an algorithm for better     glucose control in diabetic patients communicated via an App to help improve outcomes and     reduce urgent care and ER visits as well as improve A1C and quality of life.   "
72545|NCT02336191|"     A prospective Observational study including 50 living donor liver transplant recipients to     monitor the graft functions through thromboelastometry   "
72546|NCT02336178|"     The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in     subjects with hemophilia B in usual care settings in China.   "
72550|NCT02336126|"     This is a pilot study of a biopsychological intervention program for adolescent chronic     fatigue syndrome. The program is related to cognitive behavioral therapy, which has been     proven beneficial in this disorders, but includes other mental techniques, such as emotional     control and metacognitive elaboration.      The aim of this pilot study is to explore a) patients' experiences and b) possible positive     effects on symptoms. We hypothesise that the intervention will be regarded feasible by the     patients, and that fatigue score will improve during the intervention period.   "
72551|NCT02336113|"     Earlier studies have shown that pharmacists detect and solve drug related problems (DRPs)     when they are a part of the multidisciplinary treatment-team at hospital wards. However, in     the Norwegian health care system, there is a lack of studies on the effect of pharmacist     intervention on clinically relevant outcomes. Hospital readmissions has both clinical and     economical negative effects, and time outside the hospital until an eventual readmission is     considered as a clinical relevant outcome measure. We are conducting a randomized controlled     trial at an internal medicine ward at Oslo University Hospital. 400 acute admitted patients     using minimum 4 regular drugs from minimum 2 drug groups will be enrolled in the study.     Patients randomized to the Control group will receive standard care (without a pharmacist     involved) and patients randomized to the Intervention group will receive a pharmacist in     their treatment team during the hospital stay. The study hypothesis is that including a     pharmacist in the multidisciplinary treatment team at a hospital ward, will improve the     patients drug treatment, hence lead to an increased time outside the hospital until an     eventual readmission.   "
72552|NCT02336100|"     Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy     were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were     analyzed.   "
72553|NCT02336087|"     This pilot phase I trial studies the side effects of gemcitabine hydrochloride, paclitaxel     albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a standardized     dietary supplement in treating patients with pancreatic cancer that cannot be removed by     surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and paclitaxel     albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Metformin hydrochloride, used for diabetes, may also help kill cancer cells.     Dietary supplements (curcumin, vitamin D, vitamin K2, vitamin K1, B-6, high selenium broccoli     sprouts, epigallocatechin gallate, L-carnitine, garlic extract, genistein, zinc amino     chelate, mixed toxopherols, ascorbic acid, D-limonene) can block different targets in the     cancer cell simultaneously and may slow down cancer growth. Giving gemcitabine hydrochloride,     paclitaxel albumin-stabilized nanoparticle formulation, and metformin hydrochloride with a     dietary supplement may work better in treating patients with pancreatic cancer that cannot be     removed by surgery.   "
72554|NCT02336074|"     This study will be a two-arm prospective 1:1 randomised controlled trial comparing:      Arm A: cART preferably including raltegravir (combination ART cART - control) Arm B: cART     preferably including raltegravir (cART) plus ChAdV63.HIVconsv (ChAd) prime and MVA.HIVconsv     (MVA) boost vaccines; followed by a 28-day course of vorinostat (10 doses in total).      We hypothesise that this intervention in primary HIV infection will confer a significant     reduction in the latent HIV reservoir when compared with cART alone.   "
72555|NCT02336061|"     The purpose of this study is to evaluate of gender differences on the psychosocial and     economic impact in patients with advanced non-small cell lung cancer.   "
72556|NCT02336048|"     This multicenter, double-blind, randomized, placebo-controlled study will evaluate the safety     of a single infusion of tocilizumab versus placebo, administered in addition to standard     premedications (antipyretic, antihistamine, and corticosteroid) prior to the first infusion     of obinutuzumab administered in combination with oral chlorambucil to participants with     previously untreated B-CLL who have comorbidities. All eligible participants will be treated     with a total of 6 cycles of obinutuzumab + chlorambucil (cycle length = 28 days).   "
72557|NCT02336035|"     Eligible patients that sign an informed consent will be randomized to operation with volar     locking plate or cast immobilization. Primary follow-up after 1 year.   "
72558|NCT02336022|"     Pediatric postoperative patients are at increased risk for post-operative respiratory     complications such as hypoventilation. There is no objective measure of early respiratory     parameters that would predict respiratory compromise after surgery efficiently in pediatric     patients. Current respiratory assessment in non-intubated patients relies on oximetry data,     impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has     been extremely helpful in recognizing oxygen desaturations but it is a late indicator of     respiratory decline. New advances in technology and digital signal processing have led to the     development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM     (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate     real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation     (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary     hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV,     RR and MV in pediatric patients.   "
72559|NCT02336009|"     Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with     rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of     movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty.     Several implants are available on the market and they all have different pros and cons. One     risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose,     revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the     likely alternative. Revision rates five years after the index operation have improved,     however, they cannot yet compare with the results after a total hip arthroplasty. A newly     designed TWA has been developed by the department of Hand Surgery, Örebro university     Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers     theoretical advantages and has been biomechanically tested at the Mayo clinic.      This is a pilot study where patients operated with the TWA will be assessed pre and     postoperatively according to study protocol in order to evaluate outcome after TWA     radiologically, clinically and regarding patient perceived outcome measures.   "
72563|NCT02335957|"     The main purpose of this study is to show the non-inferiority of the incidental irradiation,     as compared to intentional irradiation of the axillary nodes, in terms of 5-years     disease-free survival (DFS) of early stage breast cancer patients with limited affectation of     sentinel node assessed by OSNA (250 to 15,000 copies/uL), treated with breast-conservative     surgery without axillary lymphadenectomy.   "
72564|NCT02335944|"     The study is designed to determine the maximum tolerated dose (MTD) or recommended phase 2     dose (RP2D) of EGF816 in combination with INC280 and to estimate the preliminary anti-tumor     activity of EGF816 in combination with INC280 in patients with advanced non-small cell lung     cancer (NSCLC) with documented EGFR mutation.   "
72565|NCT02335931|"     The project concerns a type of very debilitating diabetic foot complications called Charcots     osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction of     the load bearing joints, primarily in the feet, resulting in loss of structure and     remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain     and walking disability for the patient. Reconstruction is often very difficult or impossible,     and furthermore the collapse can lead to chronic foot ulcers and infections, which in the     worst case can be fatal.      Treatment options are currently limited to early diagnosis and physical offloading     (immobilisation), assisted wound healing and surgical intervention.      The purpose of this project is to investigate and describe the bone-related factors, which     separate COA from other, less acute, diabetic foot changes. The investigators wish to     describe the long term consequences of COA - both anatomically, physiologically and     biochemically.      The investigators will be doing this in a follow-up investigations on a group of COA patients     tested 8 years ago. Little is known of the long term changes to the bone structure after     acute COA, and the investigators want to visualize to what extend the bone damage is     permanent.      To do this the investigators will be using DXA-scans, x-ray, blood tests including bone     markers, neurophysiological tests and occlusion plethysmography.   "
72566|NCT02335918|"     This is a study to determine the clinical benefit (how well the drug works), safety, and     tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558). Both     drugs target the immune system and may act to promote anti-cancer effects.   "
72567|NCT02335905|"     This research study is looking at an antibiotic medicine, Ceftaroline Fosamil (Ceftaroline),     which fights infections like the one the subject has. Ceftaroline is effective against     S.aureus germs including those that are called Methicillin Resistant Staphylococcus aureus     (MRSA.)      Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in     adults with Community-Acquired Bacterial Pneumonia [a type of lung infection] and Acute     Bacterial Skin and Skin Structure Infections. Ceftaroline has been studied in children with     both simple and complicated pneumonia but the FDA has not yet approved Ceftaroline for use in     subjects less than 18 years of age. Therefore, the use of Ceftaroline in this research study     is considered investigational.      The goal of this research study is to find out what side effects there may be when children     are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections     due to Staphylococcus aureus in children. The investigators are also studying what the body     does to the study drug, Ceftaroline, and if the doses the investigators use result in blood     levels that the investigators think are going to be effective against bone infections in     children. This is called pharmacokinetics (PK).   "
72568|NCT02335892|"     Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting     multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12     months.   "
72569|NCT02335879|"     The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant     Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including     polycystic ovarian syndrome [PCOS] subjects).   "
72570|NCT02335866|"     The main objective of this study was to evaluate the clinical effectiveness of platelet-rich     fibrin membrane used in combination with a coronally advanced flap and to compare it with the     use of a subepitelial connective tissue graft in combination with a coronally advanced flap     in Miller class I-II bilateral gingival recession treatment   "
72571|NCT02335853|"     Nerve growth factor (NGF-R) receptors are between the detrusor muscle fibers and can cause     afferent signals. Metabolic syndrome and obesity have been advocated to be risk factors for     the development of overactive bladder.   "
72572|NCT02335840|"     Introduction: reduction of blood pressure after physical exercise is called post exercise     hypotension (PEH). However, previous studies demonstrate that ingestion of caffeine     equivalent to three tea-cup of coffee abolishes this phenomenon. Objective: evaluate the     influence of different doses of coffee in PEH. Methods: eleven hypertensive performed four     experimental sessions of aerobic exercise in cycle ergometer (40 minutes of duration,     intensity between 60% and 80% of maximum heart rate) succeeds for the ingestion of one     (CAF-1), two (CAF-2), three (CAF-3) doses of caffeinated coffee (144 mg/dose), or three doses     of decaffeinated coffee (DESC). Blood pressure was measured in rest and during 120 minutes of     recovery post exercise, each 10 minutes.   "
72573|NCT02335827|"     The purpose of this study is to investigate the safety and efficacy of irreversible     electroporation (IRE) for unresectable renal tumors.   "
72574|NCT02335814|"     This first-in-human (FIH) clinical trial is a Phase 1/1b, open-label, sequential-group,     dose-escalation and cohort expansion study evaluating the safety, PK, PD, and antitumor     activity of FLX925 in subjects with relapsed or refractory AML.   "
72575|NCT02335801|"     The objective of this study is to determine whether the presence of metabolic alteration and     anabolic deficiencies in patients with chronic heart failure are able to identify a subset of     patients with poor outcome.   "
72576|NCT02335788|"     This is an open label, acute, non-randomized, prospective, first in man (FIM) single-center     study of the EMBA Medical Peripheral Embolization Device (PED).   "
72584|NCT02335684|"     This randomized trial has been designed to study if it is possible to enhance work capacity     during submaximal efforts in heart failure patients supported with continuous-flow left     ventricular assist devices (CF-LVAD).      The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD     patients can be increased when pump speed is increased soon after the onset of exercise.   "
72577|NCT02335775|"     The purposes of this study are to determine whether total lymph node count or the percentage     of identified nodes with metastatic disease are influenced by (1) the method of categorizing     tissue specimens or (2) the techniques of pathologic processing following lymphadenectomy.      Patients with newly diagnosed endometrial carcinoma of high risk histologic type or uterine     carcinosarcoma whose risk of LN metastasis exceeds 15% will be enrolled on this study.     Patients will undergo staging to include hysterectomy and selective lymphadenectomy as per     the clinical judgment of the primary Gynecologic Oncologist. Type of hysterectomy and the     extent and distribution of lymphadenectomy is at the discretion of the surgeon. All patients     will be scheduled for surgical staging. Each subject will have lymph nodes harvested on one     side divided into specific basins, and on the contralateral side classified only as pelvic     or aortic. Surgical node specimens in the operating room will be labeled by (1) specific     nodal basins on the randomly determined side as external iliac, obturator, common     iliac, aortic, or high aortic and by (2) pelvic versus aortic (common iliac nodes     will be considered as part of the pelvic specimen) on the contralateral side.   "
72578|NCT02335762|"     40 healthy subjects were recruited using advertisements posted at the Catholic University of     Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a     Gima scale) of each subject were measured and the body mass index (BMI) was calculated     (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all     food and drink consumed daily for 3 days using a diary previously used in the Italian     National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate     as best their habits. They were educated to report also the place, time, number and quantity     of serving portions consumed. If they were not able to weight exactly each portion, a     photographic atlas developed for the Italian component of the European Prospective     Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days     the food diaries were checked and for each subject the energy intake was estimated.   "
72579|NCT02335749|"     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area     applicator for non-invasive subcutaneous fat reduction in the distal thigh.   "
72580|NCT02335736|"     The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF)     patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal     females undergoing IVF. Can it be used with the same efficacy in all patients?   "
72581|NCT02335723|"     The primary objective of this clinical investigation is to investigate the feasibility and     possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with     presumed endotoxemia of abdominal or urogenital origin.   "
72582|NCT02335710|"     Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty     was analyzed by the Center for Musculoskeletal Research in a past research study, and it was     determined that subjects experienced more normal-like kinematic patterns. They also achieved     excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew     has made modifications to the Journey bi-cruciate stabilizing (BCS) total knee arthroplasty     (TKA) design, researchers will again evaluate the kinematics of subjects implanted with the     revised design to determine if subjects experience normal-like kinematic patterns and if     greater weight-bearing knee flexion is achieved. The objective for this study is to analyze     the in vivo kinematics for subjects implanted with a 2nd generation Journey BCS TKA and     compare those patterns to subjects having a normal knee and those having the 1st generation     Journey posterior stabilizing (PS) TKA that were analyzed in the previous study.   "
72592|NCT02335580|"     The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%.     Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic     patients remains under debate. Considering that PVT potentially elevates the portal pressure     and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk     varices and variceal bleeding as the study population. Thus, the main goals are to analyze     the effect of PVT on the incidence of first variceal bleeding in patients without any prior     bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in     patients with a history of variceal bleeding, and the treatment failure rate of variceal     bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed     in all patients.   "
72593|NCT02335567|"     To compare two competing newly designed 3D sequences for black blood carotid plaque imaging     techniques with the industry standard 2D sequnce for black blood.   "
72668|NCT02334579|"     The purpose of this study is to find out the effects (good and bad) of highly focused     radiation on you and your prostate cancer. The purpose of this evaluation is to see if this     treatment causes fewer side effects that other standard treatment approaches, and to evaluate     the effect of this treatment on your prostate tumor and your quality of life over time.   "
72583|NCT02335697|"     Female circumcision (FC) causes both immediate and long-term health consequences. In general,     the more severe type of FC, the worse health consequences can be seen. Despite the negative     health effects, the practice of FC is still found to be highly prevalent in many countries,     mainly in Africa and the Middle East. Many studies have been performed on FC in African     countries where the custom is widespread and there have also been many attempts to eradicate     the practice in these countries. However, considerably less research exists on FC in     non-practicing societies where there has been an influx of immigrants from countries that     traditionally carry out this practice. Further, no anti-FC interventions designed using a     comparison group have been performed in any country outside Africa.      This cluster randomized controlled trial aims to evaluate the effectiveness of a     community-based participatory intervention on changing attitudes towards FC among newly     arrived Somali immigrants in Sweden. Included in the research is an assessment of the     acceptability of the intervention. Based on social convention theory, we hypothesize that an     interaction between established Somali immigrants, thought to be predominantly opponents of     FC, and newly arrived Somali immigrants will facilitate changes in attitudes among the newly     arrived.      The trial will be implemented in two municipalities in Sweden that have a high proportion of     Somali immigrants. Somali organizations in these municipalities will constitute the clusters.     In total, 8 clusters will be included, 4 intervention clusters and 4 control clusters.   "
72599|NCT02335476|"     The investigators will use optical coherence tomography to detect the ex-vivo tissue image of     surgical removed melanoma or other benign pigmented lesions of skin.   "
72585|NCT02335671|"     The purpose of this study is to investigate the use of intra-operative Magnetic Resonance     Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine     if these tests are capable of accurately predicting the presence or absence of breast tumor     in surgical specimens at the margins.   "
72586|NCT02335658|"     The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.   "
72587|NCT02335645|"     This case series will follow standard ACL protocol, while using biomechanical movement     analysis to analyze running mechanics using a body weight supported treadmill.      Standard ACL protocol will be followed throughout the treatment of each patient. The only     variance from treatment will be using motion analysis software to analyze gait patterns at     different points throughout the rehabilitation.      The first motion analysis will be performed at week 6 of the rehabilitation process. Prior to     this treatment, manual muscle testing of the hip, knee and ankle using a handheld     dynamometer, two outcome measures, range of motion, pain, and patient satisfaction will be     performed. At this treatment, motion capture sensors will be placed on the patient at     different anatomical positions. The patient will then run in a body weight supported     treadmill. During this run, video capture will be performed and later analyzed to determine     biomechanical kinematics.      This process will be repeated at week 8 of rehabilitation in the body weight supported     treadmill.      At week 10, the patient will shift treatment from the body weight supported treadmill, to a     standard treadmill. The process will be repeated using the same anatomical landmarks and     video capture.      The final video capture will be performed at week 12. At this visit, video capture will be     performed. The patient will also repeat all test, measures, and questionnaires from week 6.      At all visits between video capturing, standard PT will be performed with a focus on patient     deficits and following the standard protocol.   "
72588|NCT02335632|"     Background/Aims:      The investigators explored the therapeutic effects of probiotics in patients with AH.      Methods:      Between December 2012 and January 2015, the investigators conducted a 7-day,     double-controlled, randomized, prospective clinical trial comparing the efficacy of     probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and     stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an     aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT)     level with an alcohol consumption history within 48 hours. Patients were randomized to     receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or     placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and     pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing     gradient gel electrophoresis were checked at baseline and again after therapy.   "
72589|NCT02335619|"     Currently at the BC Cancer Agency, oncologists decide when to refer a patient to the Pain and     Symptom Management/Palliative Care (PSMPC) team, and their decisions are made subjectively     and without standard guidelines/symptom assessment tools. Patients are often referred late in     their treatment. The PSMPC team sees patients in their own clinic, separately from the     oncologists, and do not often collaborate in a patient's care.      Early integration of palliative care into oncological care has been shown to improve quality     of life and to prolong survival, as well as to reduce inappropriately aggressive oncological     care at end of life, and reduce costs of care. We will test an early oncology-integrated     palliative care model, with the aims of determining whether 1) the introduction of PSMPC     support at the time of diagnosis leads to better symptom management and quality of life of     patients, 2) early integration of palliative care into medical oncology care reduces     aggressiveness of cancer treatment near end of life, and 3) a fully integrated service     delivery model is sustainable.   "
72590|NCT02335606|"     Abatacept Registry in Taiwan   "
72591|NCT02335593|"     The purpose of the study is to evaluate the effect of Zinc supplementation on health status     of hemodialysis patients through measurement of the following before and after Zinc     administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also,     Evaluation of quality of life of hemodialysis patients before and after Zinc administration     using Fatigue severity scale questionnaire.   "
72609|NCT02335346|"     The purpose of this study is to assess the safety and efficacy of duloxetine in participants     with osteoarthritis and knee pain. The study will last for 1 year.   "
72594|NCT02335554|"     Depression is one of the most prevalent mental disorders to afflict adults. It seriously     impacts role functioning and often takes a recurrent or chronic course. Because most adults     who suffer from depression never receive treatment, there is a critical need to develop     interventions that can be easily implemented and widely disseminated. Interventions that     reduce the performance-impairing symptoms of subclinical depression and prevent the onset of     major depression can improve employee well-being, while reducing healthcare costs and     improving productivity. This project produced a mobile-web program to activate cognitive     behavioral skills in workers with subthreshold depression, reduce depression symptoms,     improve functioning in the workplace, and potentially reduce the risk for escalation to     full-syndrome depression.   "
72595|NCT02335528|"     SimCoach, a computer program featuring a virtual human that speaks and gestures in a     videogame-like interface, is designed to encourage servicemembers, especially those with     signs or symptoms of post-traumatic stress disorder (PTSD) or depression, to seek help to     improve their psychological health. The assessment included a formative component assessing     SimCoach's design, development, and implementation approaches, as well as a summative     component assessing outcomes among participants in a user experience survey and a randomized     controlled trial (RCT).   "
72596|NCT02335515|"     The primary objective of the study was to assess the gastric residence time (GRT) of the     Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial     screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that     the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer     compared to literature values reported for a simliar sized capsule.   "
72597|NCT02335502|"     04-SMI-2012 is post market, observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     chronic, intractable pain.   "
72598|NCT02335489|"     14-SMI-2013 is a post market, observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     neuropathic pain of the foot and/or lower limb   "
72601|NCT02335450|"     This study evaluates the effectiveness of personalized physical activity coaching combined     with the use of a physical activity monitor to support increased levels of daily physical     activity in individuals with multiple sclerosis. All five participants will receive the     intervention over the four week intervention phase.   "
72602|NCT02335437|"     Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting     fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms.     Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents     undergoing acute EBV infection will be followed prospectively, and also compared with a group     of healthy controls. The aim is twofold:        -  To identify factors that predispose to chronic fatigue among adolescents with acute EBV          infection        -  To compare pathophysiological features of patients with acute EBV infection with a group          of healthy controls.      Possible risk factors for chronic fatigue 6 months after EBV-infection includes:        -  Severity of the initial infection        -  Immune responses characteristics        -  Characteristics of the neuroendocrine stress response        -  Cognitive functioning        -  Emotional disturbances        -  Genetics/ epigenetics of candidate genes        -  Certain personality traits        -  Critical life events   "
72603|NCT02335424|"     This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of     participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are     ineligible for cisplatin-based therapy. The primary study objective is to determine the     objective response rate (ORR) in all participants, in participants whose tumors rely on     programmed cell death ligand 1 (PD-L1) protein (PD-L1-positive tumors), and in participants     with strongly PD-L1-positive tumors.   "
72604|NCT02335411|"     This is a study of pembrolizumab for advanced gastric or gastroesophageal junction     adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had     previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as     combination therapy with cisplatin and 5-Fluorouracil (5-FU) or (Japan only) capecitabine in     treatment-naïve participants. The primary study hypothesis is that pembrolizumab will provide     a clinically meaningful overall response rate.   "
72605|NCT02335398|"     Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in     pain management. However, methadone usage for pain control in Thailand has been limited     because physicians are not familiar with its dosing and concern about the risk of drug     accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to     evaluate the efficacy and safety of a methadone protocol in Thai patients with severe chronic     noncancer and cancer pain.   "
72606|NCT02335385|"     Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of     varicocele in our department since the nineties. However, the relatively several trocar     wounds represent a big challenge against its acceptance by many of our patients who prefer     the open approach with one or at least two wounds.      Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven     to be feasible and effective, with high patient satisfaction rates regarding improved     cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10,     11) SILS for varicocelectomy has been reported to be safe and effective alternative to     conventional laparoscopic varicocelectomy in a few studies.   "
72607|NCT02335372|"     Objectives:      Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for     detection of cervical neoplasia in Brazil.      Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate     the highest degree of correlation with disease state.   "
72608|NCT02335359|"     The purpose of this study is to determine whether tranexamic acid is effective in reducing     intraoperative blood loss and necessity for haemotransfusion in patients undergoing open     abdominal aortic aneurysm repair   "
72610|NCT02335333|"     The primary purpose of this study is to measure the correlation between baseline expression     of aging biomarkers, SenesceTest in blood of organ donor and renal graft function. This pilot     study will study patients who are undergoing renal transplantation with organs from extended     criteria donors, standard criteria donors or donation after cardiac death and compare ability     of SenesceTest to predict renal graft function immediately after the transplant and at 1 year     followup.   "
72611|NCT02335320|"     Acute or chronic HCV infection can lead to liver complications, including liver failure,     cirrhosis or liver cancer. For patients with hepatitis C infection, the major clinical     question remains the terms of treatment initiation. In Europe, new treatments are available     since the approval of three direct acting antivirals. However with the high cost of these     treatments, they are currently only available for critically ill patients. Other molecules     are currently in advanced clinical development phases. The use of clinical predictors remains     relevant for the selection of a suitable treatment for each patient, in particular to limit     the adverse effects and reduce costs. Currently the quantification of viral load is a measure     of response to treatment; with the recommendation to stop treatment in patients who fail to     achieve an undetectable level of viral load. Genetic factors have also been identified as     predictors of response to treatment, in particular polymorphisms of the IL-28B gene.     Genotyping of this gene is currently performed using classical PCR amplification applied to     DNA extracted from blood, with a time to result of 2-3 weeks. We propose in this protocol to     test a non-invasive method and rapid test for IL-28B genotype which could be used for point     of caring testing, and ultimately better patient management.      This is a monocenter, cross-sectional study among HCV chronic patients. The study will be     conducted in 250 HCV patients, all viral genotypes combined, at Cochin Hospital (Paris,     France).      Objectives The principal objective is to assess the accuracy of the newly developed     Point-of-Care genotyping assay (Genedrive® IL-28B Assay) to detect in HCV patients the     genotype CC versus non CC (i.e. CT and TT) against the TaqMan Allelic Discrimination Assay as     gold standard.      The secondary objective is to assess the concordance between the genotype results of the     Genedrive and the gold standard regarding the three genotypes CC, CT and TT.   "
72612|NCT02335307|"     This study will examine the effect of having genotype information on pain management and pain     control for patients treated in family medicine clinics. This study will also examine     physician-perceived usefulness of genotype information. Patients will be enrolled from family     medicine clinics serving as either implementation sites or control sites. Patients from     implementation sites will undergo genotyping, while those from control sites will not by     genotyped.   "
72613|NCT02335294|"     The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with     placebo in patients with acute postoperative pain following abdominoplasty.   "
72625|NCT02335138|"     The proposed research aims to address the question: Compared to the current standard of care     for home-based HIV tests, in which persons conduct and interpret HIV tests without     counseling, does the addition of video conferencing with a remote counselor increase     health-enhancing, protective behaviors among male-male couples and facilitate linkage to care     for those who test positive?   "
72614|NCT02335281|"     There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now     the investigators realized that the intestinal microecological is closely associated with the     development of IBD. So the standardized fecal microbiota transplantation is considered to be     simple but effective emerging therapies for the treatment of IBD. In this project the     investigators intend to carry out a single-center, randomized, single-blind clinical     intervention study. The investigators will recruit 40 patients with IBD (20 cases of     Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly     divided into 2 groups, one group will be given treatment of standardized fecal microbiota     transplantation, the other will be simply treated with mesalazine, followed up for at least 1     year. The investigators propose to determine the efficiency, durability and safety of     Standardized Fecal Microbiota Transplantation for IBD treatment.   "
72615|NCT02335268|"     There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients     classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS     found that baseline concentration of TPO as well as transfusion history were predictive of     subsequent response in a retrospective model. The current prospective study has the aim to     explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion     history) can predict the response to subsequent short-term treatment with romiplostim.   "
72616|NCT02335255|"     To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to     Naftin® (Naftifine Hydrochloride) Gel 2%   "
72617|NCT02335242|"     A Phase 2 study to evaluate safety and efficacy of sildenafil taken orally to improve or     resolve lymphatic malformations in children. Subjects may receive either placebo or treatment     in an oral dosage with an open label extension for subjects who received placebo. The study     treatment assignment will be randomized in a double blind fashion. MRI examination will     evaluate change in lesion volume due to treatment. Other safety and efficacy measures will be     taken through the 32-week study duration.      Funding Source - FDA OOPD   "
72618|NCT02335229|"     20-SMI-2013 is a post market, observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     chronic post surgical pain   "
72619|NCT02335216|"     18-SMI-2013 is a post market, observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)   "
72620|NCT02335203|"     Objective: To compare pre- and post-treatment glandular cellularity in women with complex     atypical hyperplasia or grade 1-2 endometrial adenocarcinoma who are treated with     intramuscular depot medroxyprogesterone acetate (DMPA) versus placebo injection prior to     hysterectomy. The secondary objective is to compare various other outcomes including     molecular, histologic, pathologic and clinical endpoints in women treated with DMPA versus     placebo prior to hysterectomy.      Hypothesis: Patients treated with DMPA will have significantly decreased glandular     cellularity post-treatment when compared to patients treated with placebo injection. Patients     treated with DMPA will exhibit previously described changes in molecular tumor marker     expression patterns and other characteristic histologic changes. Patients treated with DMPA     will report less bothersome vaginal bleeding prior to surgery when compared to patients     treated with placebo injection.      Study Design: Double blinded randomized controlled trial      Population: Women being treated at the Women and Infants Program in Women's Oncology who have     a biopsy-proven diagnosis of complex atypical hyperplasia or grade 1-2 endometrial     adenocarcinoma with disease clinically confined to the uterus, with a plan to undergo     hysterectomy.      Study Period: February 2015 to June 2016   "
72656|NCT02334735|"     Vaccine adjuvants are compounds used to increase specific immune responses to antigens, but     have minimal toxicity or lasting immune effects on their own. This study investigates the use     of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to     Montanide® in study subjects with melanoma in complete clinical remission.   "
72621|NCT02335190|"     The sacroiliac (SI) joint is a common source of low back pain. Radiofrequency ablation (RFA)     can be used to treat low back pain from the SI joint , and is often recommended by physicians     to provide long lasting pain relief. However, the use of RFA for SI joint pain has not been     as successful as RFA for pain in other areas of the back and neck. X-ray guidance     (fluoroscopy) is currently used to perform this procedure. Under fluoroscopy, however, it can     be difficult for physicians to identify necessary landmarks, and there are risks to the     patient because of radiation exposure. In contrast, ultrasound may provide better image     guidance than fluoroscopy, and there is no radiation risk. The purpose of this study is to     examine if ultrasound guided SI joint RFA is effective.   "
72622|NCT02335177|"     Elderly people are still at risk for falling at home. The objective of the study is to     evaluate at home the impact of an intervention for 3 months combining technologies for     autonomy and tailored physical activity program. The study is performed among patients aged     75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of     professional home-care service Ages & Vie and with a loss of autonomy requiring physiotherapy     and home support workers. It is a prospective, randomized, single-center, in cluster study     which compares a Patient group (interventional group) with the intervention program     (technologies + physical activities) with a control group benefiting from usual care home.     Our hypothesis is that in the interventional group fewer falls were observed and improved     different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke)     were reported compared to the control group.   "
72623|NCT02335164|"     Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against     avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza     influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to     increase its immunogenicity. This Phase 1 study will collect preliminary human safety and     efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant     formulations administered by intramuscular injection   "
72624|NCT02335151|"     Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor     removal of pancreatic cancer will be determined and correlated to the accordance of     anesthesia (desflurane versus propofol)   "
72628|NCT02335099|"     This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients     with ESRD on chronic HD and a functioning AVF will be recruited. The following data will be     documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD     3-Time since access was placed 4-Type and place of access and blood flow rate of access     5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery     disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current     medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets,     digoxin, statins). Patients will be randomized into two groups to receive: Group 1:     Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.   "
72629|NCT02335086|"     The purpose of this study is:        1. To examine the association between stable and unstable coronary artery disease (CAD)          with markers of DNA damage and repair,        2. To examine the association between plaque morphology as assessed by frequency-domain          optical coherence tomography (FD-OCT) and markers of DNA damage and repair in order to          identify potential markers of plaque instability,        3. To examine the association between markers of DNA damage and repair and major adverse          cardiovascular events defined as death, MI and unplanned percutaneous or surgical          revascularization,   "
72630|NCT02335073|"     Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many     limitations, such as sampling error and individual variation in interpreting the results.     Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver     fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN),     hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III     (PIIINP). However, few study was conducted to explore the role of these liver fibrosis     markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV,     and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.   "
72631|NCT02335060|"     The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the     acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating     healthy individuals with NAC and then assessing their responses to THC.   "
72632|NCT02335047|"     Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the     psoas muscles, even when the subject has been told not to contract any muscles. The psoas     contraction is involuntary and cannot be controlled by the subject. This lack of passivity     might be concomitant with lower back pain: the impairment may be present when lower back pain     is present and/or absent when lower back pain is absent.      The study's primary objective is thus to determine the sensitivity and/or specificity of a     clinical test for impaired hip flexor passivity in cases of lower back pain during passive     flexion of the trunk (from the supine position,).      The secondary objective is to show that a negative test (after administration of correcting     measures) is correlated with a decrease in pain (i.e. pain intensity and the functional     repercussions of pain).   "
72657|NCT02334722|"     The purpose of this study is to see if there are any differences between patients who receive     Levetiracetam extended-release tablets for one week after surgery to remove a brain tumor     versus those who receive Levetiracetam extended-release tablets for six weeks after surgery.     Specifically, we will see if one group has less side effects than the other, and whether or     not one group has more seizures than the other.   "
72633|NCT02335034|"     OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a     multidisciplinary care program with and without associated classroom educational program.     METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of     Kelgren and Lawrence. Have been treated with drugs, orthotics and referred to physical     rehabilitation (physiotherapy and/or physical activity). Patients will be randomized into 2     groups of 76 and will go through pre-assessment with multidisciplinary team: Psychologist -     assess cognitive ability; level of anxiety, and depression. Nutritionist - anthropometric     parameters and diet quality. Social Worker - Level of education, religion, autonomy and     mobility capacity to the hospital. Physiotherapist - range of motion, pain, function and     quality of life. Occupational Therapy - range of motion and strength. Physical Educator -     level of physical activity and functional capacity. Orthopaedic - additional examinations,     disease classification, orthotics, report to Social Security and Traffic Department,     evaluation questionnaires (SF 36, VAS, WOMAC, LEQUESNE), referral to physical therapy,     physical activity and inform consent. A group will submitted to two interventions, with an     interval of two months between each intervention. The control group will only make     evaluations / consultations with all professional teams without classes for 2 years, then     will attend the courses and will be followed by two more years. Interventions will be     lectures and practices with the seven professional teams, covering the topic arthritis     (orthopedic team), what is disease, being ill, and the role of the patient in the treatment     (psychology) to obtain behavioral change. Lectures and practices with physical therapy and     occupational therapy to show the importance of exercise in relieving symptoms (physical     therapy), the importance of rest and proper ergonomics at home and at work (occupational     therapy). The nutritionist shows proper alimentation. Lecture and practice with physical     educator (showing the difference between the laber work and regular physical activity as well     as the importance of strength exercises, resistance and stretching) and theoretical class     with the social service by calling attention to the importance of leisure. After two months,     the second intervention is made in order to verify the acquired concepts. Six months, 1, 2, 3     and 4 years after the first evaluation, the groups will be called to new multi evaluation.   "
72634|NCT02335021|"     The purpose of this study is to investigate the effects of dietary exposure to artificial     sweeteners on taste sensitivity, preference and brain response in adults. The investigators     hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease     sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce     brain response in amygdala to sweet taste compared to sucrose.   "
72635|NCT02335008|"     The goal of this study is to test the hypothesis that repeated consumption of artificial     sweetener reduces sweet taste intensity.   "
72636|NCT02334995|"     Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves     dissynegy and heals soliter rectal ulcer.   "
72637|NCT02334982|"     The purpose of this study is to characterize the safety and tolerability profile of TAK-137     when administered as a single dose of tablets at escalating dose levels in healthy     participants.   "
72638|NCT02334969|"     The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the     secondary prevention of ischemic stroke by the multi-center,     randomized,double-blind，placebo-controlled trial design project.   "
72639|NCT02334956|"     120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls     will be administered a whole-brain imaging exam. The current research project constitutes a     highly novel approach to understanding the pathophysiology of addiction through its     combination of neuroimaging with state-of-the-art information concerning the real-time     expression of risk factors.   "
73325|NCT02325986|"     The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy     concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative     locoregional recurrence of esophageal squamous cell carcinoma.   "
72640|NCT02334943|"     Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral     treatment. This immune activation is responsible for immune deficiency as well as for     non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome     or osteoporosis. The goal of this observational transversal multicentric study is to     establish the etiologic factors of persistent immune activation in treated HIV-1 infected     patients (persistent de novo infection of T CD4+ cells, microbial translocation, active     coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different     forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes,     platelets, endothelial cells or general inflammation) and the potential correlation between     causes, forms of immune activation and emergent comorbidities (kidney, bone or liver     dysfunction, metabolic syndrome).   "
72641|NCT02334930|"     PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological     similarities were seen between PEComa and infantile hemangioma. Propranolol is highly     efficient to treat infantile hemangioma and we believe that this drug can also be useful for     the treatment of PEComa.      Purpose : to understand the mechanism of action of propranolol in PEComas and related     pediatric vascular lesions and to select possible novel targets of betablockers in vascular     tumors related to PEComas by using YAP oncogene activation as a molecular marker   "
72642|NCT02334917|"     This study is being carried out to assess equivalence of scar outcome for two absorbable     sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable     polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important     because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there     is no evidence indicating if any of the sutures above allow for a better cosmetic outcome     (less erythema, edema, and scarring).   "
72643|NCT02334904|"     Significant changes in brain morphology are observed in people with first-episode psychosis.     Studies have shown that total brain volume and particular brain structures are decreased in     people with psychosis disorders. Recent evidence suggests that some atypical antipsychotic     drugs can maintain or increase brain volumes. Thus, we plan to use MRI scans to measure     changes in brain morphology in subjects recently diagnosed with bipolar or psychosis     disorders who are taking the atypical antipsychotic drugs aripiprazole or risperidone.     Secondary objectives include taking blood samples for fasting metabolic indices and     neuropsychiatric measures for comparisons between drug treatments.   "
72644|NCT02334891|"     The purpose of this study is to investigate the patient characteristics, selection of     treatment, and factors associated with clinical outcomes in Japanese patients with acutely     decompensated congestive heart failure.   "
72645|NCT02334878|"     This study evaluates the effectiveness of mesenchymal stem cells in treatment of stress     urinary incontinence due to intrinsic sphincter deficiency; in which the problem is weakness     or damage of the sphincter muscle responsible for continence. Mesenchymal stem cells are     undifferentiated cells which can undergo self-renewal & differentiation into other cell types     like muscle cells; thus can be used to regenerate the damaged sphincter muscles. In this     study mesenchymal stem cells will be obtained from bone marrow from the patient, processed, &     then re-injected periurethrally. Effectiveness will be compared to that of the surgical     treatment (tension-free vaginal tape).   "
73189|NCT02327793|"     The purpose of this study is to provide a description of blood flow changes in the brain     after blood pressure lowering drugs are given. This information will be used by physicians to     guide blood pressure lowering therapy in stroke patients in the future.   "
72646|NCT02334865|"     This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete     Freund's adjuvant together with sargramostim in treating patients with newly diagnosed     multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from     survivin peptide may help the body build an effective immune response to kill cancer cells     that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune     response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may     increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine     in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide     maintenance therapy may be a better treatment for multiple myeloma.   "
72647|NCT02334852|"     The AF is the most common arrhythmia in clinical practice affecting 1-2% of the general     population. It is the most common cause of cerebrovascular events (CVE), responsible for 25%     of all ischemic strokes and 50% of cardioembolic strokes.      The CARMEN-AF registry is planned to be the first registry of non-valvular AF in Mexico with     national representation, planning and specific objectives for publications. Follow-up period     of two years is planned.   "
72648|NCT02334839|"     Preeclampsia toxemia (PET) is a pregnancy related complication that is usually expressed as     new onset hypertension and proteinuria after 20 weeks of gestation. scarce data exists     regarding the effectiveness of PAT plethysmography use in women with PET and whether adverse     results are found compared to healthy gravidas. Thus, we aimed to assess endothelial function     using PAT plethysmography in women with PET and compare their results to both healthy     gravidas and those with only gestational hypertension.   "
72649|NCT02334826|"     The purpose of the study is to investigate the extent of ischemia and left ventricular     function in cardiovascular magnetic resonance (CMR), as well as patency of coronary arteries     and grafts in coronary computed tomography angiography at 12 months follow up in patients     with advanced coronary artery disease treated with percutaneous coronary intervention with     the implantation of bioresorbable scaffolds or coronary artery bypass graft surgery.      Additionally, the clinical results of the two methods of revascularization will be carried     out annually up to 5 years.   "
72650|NCT02334813|"     Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1     between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and     six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary     endpoint is duration of remission defined as platelets ≥50/nl.   "
72651|NCT02334800|"     This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of     palbociclib administered to healthy volunteers, and subjects with mild, moderate, and     severely impaired hepatic function.   "
72653|NCT02334774|"     Endotracheal intubation may contribute to the difficulties in swallowing and subsequent oral     intake. Estimated 62% of patients who had been intubated ≧48 hours will experience     post-extubation dysphagia. Clearly, intervention is needed but studies are lacking in this     regard. Thus, the objective of this pilot trial is to evaluate effects of an Oral Swallowing     Care Program on swallowing and oral intake status in patients following prolonged     endotracheal intubation.      This study employs a before-and-after intervention design. We will enroll 80 post-extubated     adult patients (50 years old and older) who had prolonged (≥48 hours) oral endotracheal     intubation from six medical intensive care units at a medical center in Taipei, Taiwan.     Participants will be assessed within 48 hours post-extubation for the baseline data, then a     14-day, daily Oral Swallowing Care Program involves moisturizing and cleansing oral cavity,     massaging salivary gland, oral motor exercise, and intake education will be provided. Outcome     will be assessed on 7th, 14th, and 21st day post-extubation including oral health status,     oral sensation (stereognosis, light touch and two-point discrimination), tongue and lip     strength, salivary secretion, body weight. In addition, Three-Step Swallowing Screen (3-SSS)     and Functional Oral Intake Scale will be assessed daily. The data will be analyzed by SAS 9.3     software package.   "
72654|NCT02334761|"     Over the past decade the paradigm of care in oncology has evolved with the advent of     personalized medicine. Yet, despite this exciting prospect, there are currently only a few     disease subtypes where therapeutic approaches with proven benefit exist such as EGFR targeted     therapies in EGFR-mutant lung tumours. With the increasing number of novel molecularly     targeted agents available, the importance of building our understanding of cancer biology is     critical.      Challenges to implement personalized medicine include the limitations of molecular testing,     tumour heterogeneity and molecular evolution, costs, and the quality and morbidity associated     with tumour biopsies. Sequential biopsies are essential to better understand biological     markers of response and resistance, and identify predictive or prognostic markers. Despite     the scientific rationale for biopsies, incorporating them into practice can be challenging,     as in many cases there is no direct advantage to the patient. This project aims to understand     the effect of research biopsies on the patient. The Investigator hypothesize by learning more     and gaining a better appreciation of the impact on the patient, Investigators will increase     the likelihood of achieving serial biopsies.      The ability to obtain serial biopsies is dependent on the patient's experience. To understand     the clonal progression of cancer and validate predictive and prognostic markers of response,     studies now target biopsies both at enrollment and at progression. As Investigators strive to     achieve this, improving our understanding of the patient's experience will help us identify     factors that positively and negatively impact on patient participation and influence the     probability of successfully obtaining sequential samples.   "
72655|NCT02334748|"     The objective of this extension protocol is to collect safety data (serious and non-serious     adverse events) and to provide continuous canakinumab to patients in France who completed     study CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 until a decision regarding reimbursement     in France is effective for canakinumab (Ilaris®) in these indications.   "
73236|NCT02327156|"     The investigator evaluated the motor and sensory block durations and the postoperative     analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in     patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered     as a primary endpoint.   "
72658|NCT02334709|"     Tyrosine kinase inhibitors (TKIs) are often used in the standard treatment for patients with     metastasized renal cell carcinoma. In addition to their ability to specifically inhibit tumor     growth, TKIs also interfere with the vascularisation of the tumor. Unfortunately, most     patients do not obtain long-lasting clinical benefit from this treatment. The goal of the     current study is to enhance the effect of TKIs by combining them with stereotactic     radiotherapy treatment of one of the metastases. This type of radiotherapy allows us to     precisely irradiate the tumor with minimal effect on the surrounding healthy tissue. Recently     it has been demonstrated that this type of radiotherapy stimulates the immune system to     attack the tumor. By combining stereotactic radiotherapy with TKIs we expect to observe a     reduction of metastases in a bigger population of patients.      In the first part of our study we focus on the safety of the combination therapy. In the     second part we will evaluate the combined treatment response.   "
72659|NCT02334696|"     The IMPROVA study is designed to identify novel predictors of vascular access success or     failure. Clinical assessment complimented by Doppler ultrasound is the only currently     employed methods of assessing suitability for placement of arteriovenous fistulae (AVF).     These techniques are not capable of predicting vascular access outcomes suggesting that other     potentially measurable factors may play a part.      Despite efforts to improve placement of AVF in both the haemodialysis incident and prevalent     population, many patients continue to dialyse through a central venous catheter (CVC),     exposing them to higher risks of infection, co morbidity and mortality than dialysing via an     AVF. Furthermore, AVF primary failure rates are reportedly as high in 20-50% in published     series confirming that ultrasound cannot inform the clinician sufficiently to accurately     predict success or failure.      The aim of this study is to perform enhanced assessments of arterial health preoperatively     and correlate these measurements with early AVF outcome. We intend to perform pulse wave     analysis and velocity; measure advanced glycation end products and assess endothelial     function using a vascular occlusion test. We also aim to assess whether patient reported     symptoms of hand function can predict AVF outcome. These non-invasive measurements will     provide a more accurate picture of overall vascular health prior to AVF formation with the     ultimate intention of informing the clinician as to the likelihood of success or failure.   "
72660|NCT02334683|"     This study seeks to compare the use of ultrasound and electrophysiologic techniques to target     muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose of this     study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT)     injection for the treatment of focal hand dystonia and upper limb spasticity.     Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard     ways of locating muscles during a treatment of BoNT injection.   "
72661|NCT02334670|"     It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV     care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100     cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with     high-dose fluconazole, and improve survival.   "
72662|NCT02334657|"     Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial     aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source     can be identified despite of repetitive radiological imaging. Patients, at least 18 months     after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining     the study purpose and the postal questionnaire consisting a short-form health survey with 36     simple questions. If we didn't receive answers after three months we made telephone     interviews with the patients' family members or their general practitioner.   "
72663|NCT02334644|"     This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with     primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota     composition in these patients.   "
72664|NCT02334631|"     Video capsule endoscopy (VCE) is a procedure where a small camera is swallowed to examine the     small bowel. Although the procedure is useful for diagnosing small bowel diseases, air     bubbles can obscure the recorded images. Simethicone is a medication that can be used to     disperse the air bubbles. However, prior studies using this medication have shown only a     modest benefit. In our study, we would like to investigate whether increasing the amount of     medication will improve the recorded images further.   "
72665|NCT02334618|"     The purpose of this study is to use a novel load monitoring technology to correlate limb     loading to ankle fracture outcomes. This study will collect continuous limb loading data and     will provide the first objective insight into how limb loading directs fracture healing.   "
72666|NCT02334605|"     Nasal hyper reactivity is defined as an increased sensitivity of the nasal mucosa to stimuli     such as temperature changes, changes in humidity, emotional stress, physical activity, smoke     and/or other scents and gives often rise to nasal symptoms such as rhinorrhea, nasal     obstruction and/or sneezing.      nasal hyper reactivity is a clinical feature of rhinitis and rhinosinusitis, affecting more     than 20% of the total Western population.      Cold, dry air exposure has been shown to be a reliable method for diagnosis of nasal     hyperreactivity. The new, shorter protocol for cold dry air provocation that recently has     been validated as a useful diagnostic tool to evaluate nasal hyperreactivity with high     specificity and sensitivity, is already a major step forward but still rather time-consuming     and not always very practical in use.      A hyperosmolar saline solution loaded on a small nasal sponge as described earlier has also     been reported as being an effective means of evaluation of nasal hyperreactivity. In     addition, capsaicin nasal spray has also been reported as being an elegant tool for the     evaluation of the response of TRP channels on the nasal mucosa.      So far, we lack data on the comparison between the 3 different diagnostic tools for the     evaluation of nasal hyperreactivity in rhinitis.   "
72667|NCT02334592|"     Health Canada's Radiation Emitting Devices (RED) Act provides exposure time guidelines for     sunbed use. These guidelines are intended to protect sunbed users from overexposure to UV     radiation. Overexposure is defined as exposure that exceeds the amount needed for vitamin D     production and could lead to skin or eye damage. Acute overexposure induces sunburn.     However, the effect of the recommended time exposure schedule on serum 25(OH)D response has     not been characterized. Further, it is unknown if the maximum time exposures are required to     reach and/or maintain optimal 25(OH)D levels. The aim of the current study is to characterize     serum 25(OH)D response to regular sunbed use following the time exposure schedule recommended     by Health Canada.   "
72669|NCT02334566|"     Immigrant and refugee children and youth are the fastest growing segment of Canadian society,     but their mental health is too often overlooked even though their high rates of symptoms are     increasingly of concern. These children and youth face the same developmental challenges as     other children, but migration and resettlement amplify challenges and also create additional     risks. Although a literature about the effects of immigrant family life on the mental health     of children exists, very little research has examined the specific extent and implications of     post-traumatic stress disorder (PTSD) among refugee children and youth. In addition, the best     practice intervention strategies that most optimally support their mental health difficulties     have not been evaluated. This study investigates the effectiveness of a treatment     intervention in a sample of refugee children: Narrative Exposure Therapy or NET and KIDNET     (developed for younger children), selected due to their documented superiority relative to     other forms of treatment for children and youth with PTSD.   "
72670|NCT02334553|"     Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild     atopic asthma.   "
72671|NCT02334540|"     The satiety effects of pulses compared to a matched smoothie will be measured.   "
72672|NCT02334527|"     This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with     metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also     referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of     first-line chemotherapy.   "
72673|NCT02334514|"     The purpose of this study is to determine the duration of viral shedding in hospitalized     patients with influenza virus, treated with oseltamivir.   "
72674|NCT02334501|"     This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed     conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and     pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.   "
72675|NCT02334488|"     Prospective, multicenter, randomized and open label study evaluating the benefit on renal     function at 12 months post-transplantation, with an immunosuppression without calcineurin     inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an     immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.   "
72676|NCT02334475|"     Chronic low back pain, with or without lower extremity pain, which arises from various     structures of the spine constitutes a majority of pain complaints. The sacroiliac joint (SIJ)     has been implicated as the primary source of pain in 10% to 27% of patients with mechanical     low back pain below L5 vertebra. The common causes of SIJ pain include a trauma like direct     fall on the buttocks, a rear-end or broad-side type motor vehicle accident, and an     unanticipated step into a hole or from a miscalculated height, fusion surgery, anterior     dislocation, inflammatory and degenerative sacroiliac joint disease and idiopathic. The     treatment of SIJ pain remains a therapeutic challenge. Besides physiotherapy and systemic     therapies including non-steroidal anti-inflammatory drugs (NSAIDs) and biologic agents,     intra-articular and peri articular injections of SIJ, radiofrequency neurotomy and surgical     fusion are often performed for pain relief. However, the success of these interventions has     been determined according to the therapeutic efficacy and correct placement of the drug. The     image guidance of SIJ injections seems to be important due to the complex anatomy of the     joint causing a low accuracy when performed according to clinical judgement only. The     feasibility of ultrasound (USG) guided injection of SIJ has recently been demonstrated     resulting in very high success rates up to 90%. Various agents being used in SIJ injections     include local anaesthetics, corticosteroid, botulinum toxin-A, 12.5% dextrose,     phenol-glycerine-glucose (P2G) and sodium morrhuate (cod liver oil extract). SIJ steroid     injection is commonly used technique and has been found to be effective to treat SIJ pain.     However, the main drawback is short term effect. Borowsky et al reported improvement in     visual analog score (VAS) of 14.1% and reduction of VAS ≥ 50% in only 12.50% patients at 3     months after intra-articular steroid (2 mL 0.5% bupivacaine plus 40 mg methylprednisolone)     SIJ injection. Treatment modalities being currently used do not, in general, address the     disease process itself, there is clearly a need to investigate treatments that are more     widely applicable for symptom management and which may also directly address the disease     process itself. Current research efforts aim at modifying the rate of healing of joint by     using biological healing factors which are various growth factors (transforming growth     factor, vascular endothelial growth factor, fibroblast growth factor, epidermal growth     factor, platelet derived growth factor etc.) found abundantly in the human blood especially     in platelets. The platelet rich plasma (PRP) is an ideal autologous biological blood-derived     product, which can be exogenously applied to various tissues where it releases high     concentrations of platelet derived growth factors that enhance the body's natural healing     response. In addition PRP possesses antimicrobial properties that may contribute to the     prevention of infections. PRP is now being widely tested in different fields of medicine for     its possibilities in aiding the regeneration of tissue with low healing potential. Local     injection of PRP is a new modality which has been effectively used for the treatment of     Achilles tendon injury in athletes, chronic epicondylar tendinopathy, chronic patellar     tendinosis, rotator cuff tear, anterior cruciate ligament injury, gonoarthrosis and plantar     fasciitis. The intra-articular injection of PRP into knee joint has been found to reduce the     incidence of local inflammatory changes in early knee osteoarthritis. Recently, PRP has been     used for low back pain caused by SIJ laxity showing significant improvement in pain scores.     However, there is no study at present comparing the efficacy of intra-articular injection of     PRP with corticosteroids for the treatment of chronic SIJ pain. Considering the vast     potential of PRP and its safety, this study aimed at studying the efficacy of ultrasound     guided intra-articular SIJ injection of leukocyte free PRP for chronic low back pain due to     SIJ pathology. In the current study, we tested the hypothesis that the SIJ injection of     leukocyte-free PRP may be more effective for the treatment of sacroiliac joint pain as     compared with steroid injection.   "
72684|NCT02334371|"     The importance of selecting patients with ovarian cancer who will benefit from either primary     debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been     acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to     be discovered. We believe that combined magnetic resonance imaging and positron emission     tomography (MR-PET) can be of great clinical value in preoperative staging of patients with     ovarian cancer.   "
72685|NCT02334358|"     To evaluate long-term safety of YVOIRE classic s by incidence of adverse events including     injection site local reactions and biodegradability   "
72677|NCT02334462|"     Background:      - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito     that carries the parasite bites them. Malaria infection does not happen in the United States,     but many people in Africa, Asia, and South America are at risk for it. Researchers want to     test two vaccines that may help decrease malaria infection.      Objective:      - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in     humans and cause an immune response that will prevent malaria parasites from correctly     growing in the mosquito.      Eligibility:      - Healthy adults ages 18 50.      Design:        -  There are several groups in this study. Each group will receive a different dose of the          vaccine and some groups will received both vaccines.        -  Vaccinations will be given on two days about 4 weeks apart.        -  Participants will receive each vaccine as an injection into the arm. Blood will be drawn          on the day of vaccination.        -  In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic          visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts          over the next 6 months.        -  At each visit, participants will be evaluated for side effects to the vaccine and any          new health changes or problems. They will be asked how they are feeling and if they have          taken any medicine. Blood and urine samples may be taken at the visit. More follow-up          visits may be needed to follow up on changes or problems.   "
72678|NCT02334449|"     Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and     multiple doses of the investigational medicinal product in healthy volunteers   "
72679|NCT02334436|"     The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum     purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines     associated with corrugator and/or procerus muscle activity in adult subjects   "
72680|NCT02334423|"     The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum     purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines     associated with corrugator and/or procerus muscle activity in adult subjects   "
72681|NCT02334410|"     After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the     associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive     bone loss in the long bones of the legs. It has been documented that the most rapid phase of     bone loss is during the first year, but bone loss can continue for a number of years     post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous     longitudinal study, in which we described rates of bone loss in the first year of SCI using     peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of     patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral     density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by     performing repeat bone scans within months of injury, we are able to detect and red-flag     those patients at highest risk of rapidly weakening bones. We propose that, once these     patients have been identified, there is an opportunity to intervene with bone-stimulating     interventions within months of injury, before BMD reaches dangerously low values. In this new     phase of the research, therefore, we are introducing an intervention phase to the     longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body     Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone     losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to     encourage bone formation. If shown to be successful as an early bone-stimulating     intervention, it may prove to be a tool for reducing future fracture risk in patients with     SCI.   "
72695|NCT02334228|"     Few studies targeting obesity in serious mental illness have reported clinically significant     risk reduction, and non have been replicated in community settings or demonstrated sustained     outcomes after intervention withdrawal. The researchers sought to replicate positive health     outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program     across urban community mental health organizations serving an ethnically diverse population.   "
72682|NCT02334397|"     Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to     maternal exhaustion, which leads to an inability to push effectively; 40% of operative     vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma     is increased three to four fold with operative delivery. This randomized, controlled trial     will compare rates of operative vaginal delivery and severe birth trauma in two groups of     women: (1) an intervention group who will participate in the antepartum Total Control®     fitness and education program modified for pregnancy; and (2) a control group. Women will be     recruited and followed from the second trimester until 6 weeks postpartum; all will complete     validated questionnaires regarding their (1) level of worry and knowledge about their     birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4)     satisfaction with their birthing experience and (5) level of depressive symptoms at various     time points during and after their pregnancy. Obstetrical data will also be collected.   "
72683|NCT02334384|"     The goal of this study is to demonstrate safety and tolerability of a novel antimicrobial     wound dressing, Antimicrobial TheraGauze. The unique microvillous structure of TheraGauze is     ideal for the development of an antimicrobial wound dressing. In vitro testing has     demonstrated that tobramycin is an ideal compound for integration into TheraGauze providing     excellent killing of MRSA and other organisms that commonly cause wound infections.     Tobramycin is a non-absorbable aminoglycoside that will be contained solely to the wound bed     preventing any potential for systemic toxicities. In vivo testing of tobramycin-impregnated     TheraGauze used in mouse wound models has confirmed no systemic absorption of tobramycin as     demonstrated by undetectable blood levels. TheraGauze has been commercially available for 10     years as a wound dressing. Tobramycin has been available for many years as a topical     antibiotic as eyedrops and as an inhaled antibiotic for patients with cystic fibrosis,     demonstrating excellent safety in both cases.      This Phase I trial will test Antimicrobial TheraGauze (ATG) as an antimicrobial wound packing     for patients presenting to an Emergency Department with skin abscess (furunculosis). Subjects     will either receive ATG or standard of care wound packing (cotton wick or iodoform wick).     Subjects will return to the ED in 2 days for wound packing removal and reassessment of their     wounds and symptomatology. A final followup will be performed by a physician and study     coordinator in an outpatient setting on day 7.   "
72686|NCT02334345|"     Radiotherapy may cause severe skin changes that significantly interfere with the patient's     quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and     various topical agents are recommended to help patients in the management of radiation skin     reactions, but evidence to support the value of the topical treatments of the irradiated skin     is lacking. In the present study we investigated the effects of two topical agents used as     supportive care to protect skin during radiotherapy.   "
72687|NCT02334332|"     This pilot clinical trial studies an educational brochure in preparing patients with gastric     cancer and their caregivers for recovery after surgery. Giving an educational brochure may     help prepare patients and their caregivers by improving knowledge about symptoms after     surgery. It may also improve quality of life and reduce worry after surgery.   "
72688|NCT02334319|"     This pilot clinical trial studies how well ganetespib works before surgery in treating     patients with stage I-IVA squamous cell carcinoma of the head and neck that can be removed by     surgery. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Studying samples of blood and tissue in the laboratory from patients     receiving ganetespib may help doctors learn more about the effects of ganetespib on cells. It     may also help doctors understand how well patients respond to treatment.   "
72689|NCT02334306|"     A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's     Syndrome   "
72690|NCT02334293|"     The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids,     Omegaven, would be beneficial in the management of steatotic liver injury in parenteral     nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic     acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through     the presence of small amounts of arachidonic acid, and improved clearance of lipids from the     serum.   "
72691|NCT02334280|"     The goal of this project, which has not changed, is to evaluate the statewide implementation     of a two-component intervention (health promotion plus academic detailing) with respect to     consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is     delivered to people with serious mental illness (SMI) by two community mental health clinics     (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI.     The specific aims of this study are:        1. Evaluate person-level and provider-level outcomes including: (a) consumer health          behaviors, health indicators, mental health indicators, and acute health service          utilization, (b) provider prescribing practices and program fidelity, and (c) program          costs.        2. Evaluate system-level outcomes including: (a) consumer health behaviors and health          indicators, (b) provider prescribing and program fidelity, and (c) acute services use.   "
72692|NCT02334267|"     This study is a prospective, single center, single blind (patient and laboratory),     randomized, cross-over, two week investigation of intradialytic acid-base kinetics and     physiology associated with use of two commercial acid dialysate concentrates in prevalent     hemodialysis patients.   "
72693|NCT02334254|"     To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple     antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with     atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention     (PCI).   "
77784|NCT02267720|"     The aim of this research is to investigate the survival rate and cost effectiveness of two     brands of GIC as occlusal-proximal ART restorations. Also the survival rate of the tooth will     be investigated.   "
72696|NCT02334215|"     The purpose of this study is to determine which of three approaches started in jail is more     effective in treating opioid use disorder: (1) methadone treatment without counseling (termed     interim methadone) coupled with case management (termed patient navigation); (2) interim     methadone without patient navigation; (3) or an enhanced treatment as usual including opioid     detoxification, overdose prevention and drug treatment information and referral.   "
72697|NCT02334202|"     This research study is aimed at the prevention of excessive weight gain in female military     dependents at high risk for adult obesity. The purpose of this study is to determine whether     reducing Loss of Control (LOC) eating and associated indicators through use of interpersonal     psychotherapy (IPT) will be feasible and acceptable to female adolescent dependents who     report such behaviors. Moreover, patterns in the data will be examined to assess whether IPT     influences body weight gain trajectories and prevent worsening disordered eating and     metabolic functioning among female military dependents at heightened risk for unhealthy     weight gain.   "
72698|NCT02334189|"     The study aims to test whether it is possible to reduce pressure on Emergency Departments by     sending a personal feedback letter to people who have recently attended an Emergency     Department and whose health issues could likely have been dealt with elsewhere. These     attendances clearly have many causes. However, it is likely that some attendances are due to     behavioural factors - in other words, the various ways in which users interact with services.     This study focuses on one particular behavioural factor: lack of feedback to users making     avoidable visits.      The study will take place in collaboration with an NHS hospital trust. Each week during the     trial, the hospital trust will identify those Emergency Department attendances in the last     seven days which, according to clinical judgement, could have been dealt with elsewhere.     Patients will then be randomly selected to receive a letter containing information on     alternative healthcare options for non-emergency health concerns. Patient records will be     analysed to determine whether the patients who received the letter are less likely to make an     avoidable repeat visit to the Emergency Department in the future, compared with patients who     received no letter.   "
72699|NCT02334176|"     The investigators conducted this prospective, randomized, observer-blinded, non-inferiority     trial to compare single perivascular injection to double injection (musculocutaneous nerve     and perivascular injection) US guided axillary brachial plexus block.   "
72700|NCT02334163|"     Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in     patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of     administering nitazoxanide on the improvement of patient's quality of life.   "
72730|NCT02333773|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroporation (IRE) for unresectable Portal venous tumor emboli.   "
72701|NCT02334150|"     Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether     it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled     trial examined whether CSEA affects the electrophysiological index of postpartum pelvic floor     muscle during labor. The investigators plan to recruit 300 primiparous healthy women.   "
72702|NCT02334137|"     The overarching purpose of this project is to provide diabetes education to the diverse     patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at     California Pacific Medical Center. Because of high clinic volume in a teaching environment,     our patients often experience long wait times. The goal of this program is to utilize this     wait time for diabetes education, a much-needed corollary to the eye care that patients     receive at our clinic.      This pilot project will investigate the impact of a program like this in our patient     population. Specifically, the investigators are investigating whether diabetes education     delivered in an ophthalmology setting enhances patient understanding of diabetes (via     knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This     is a 6-month study that runs through April 2015, and looks at the impact of an interactive     diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of     patients who meet with a diabetes educator will also be shown their own retinal images     (compared to a normal retina).   "
72704|NCT02334111|"     The impact of parental opioid use disorder and other substance use exposure on child welfare     and the healthcare system is undeniable. Between 2000 and 2009, the number of delivering     mothers using or dependent on opiates rose nearly five-fold, and it is estimated that 48-94%     of children exposed to opioids in utero will be diagnosed with neonatal abstinence syndrome     (NAS), a set of behavioral and physiological complications resulting from abrupt substance     withdrawal at birth. Opioid abuse is usually coupled with use of other substances, and     research has demonstrated that children born to parents with substance use disorders are     three to four times more likely to suffer abuse or neglect.      Currently, the standard of care for pregnant women who are being treated for opiate     dependence at Boston Medical Center (BMC) is to receive all their prenatal care in the     RESPECT Clinic, an innovative program of the BMC Department of Obstetrics and Gynecology     designed to treat addiction during the prenatal and early postnatal period. Once the child is     born, BMC staff files a report of suspected child abuse and neglect in accordance with the     Massachusetts General Laws section 51A. The state Department of Children and Families makes a     determination regarding the disposition of these families. Medically, most of these children     are treated in-patient at BMC for NAS and then discharged to follow-up with routine pediatric     primary care. Currently, approximately 85% of infants born exposed to opioids go home with     their mothers, and the remainder receive substitute care, either with other family members or     via foster care.      This investigation is a randomized controlled trial of RESPECT-Plus, a continuum of promising     and evidence-based practices designed to strengthen family protective factors and improve     health permanency and well-being outcomes for children born to mothers in treatment for     opioid use disorder. Anticipated outcomes of the intervention include fewer reports of     supported child abuse or neglect filings in the child's first year of life, fewer days in     out-of-home placement; fewer terminations of parental rights in the child's first year of     life; and improvements in family functions overall (e.g. improved access to basic     needs/social determinants of health, improved parental resilience, and decreased maternal     depression).   "
72705|NCT02334098|"     The objectives of this project are as follows:        1. To assess whether omega-3 dietary supplementation for six months can reduce          externalizing behavior problems (antisocial and aggressive behavior) in schoolchildren          aged 8 to 18, both at the end of treatment and six months post-treatment        2. To assess whether omega-3 supplementation can enhance cognitive and brain functioning as          measured both by neurocognitive and psychophysiological measures        3. To assess whether any improvements in cognitive and brain functioning can help account          for any improvements in behavior.   "
72706|NCT02334085|"     The HOW Study is a first-of-its-kind international online study for women and men with and     without a history of breast cancer. The investigators will collect information about your     health, your job, your diet, and your family history, among other topics that can help us get     a better understanding of breast cancer and its potential causes. Periodically, the     investigators will send you questionnaires about anything and everything. All you have to do     is fill them out online. It's that simple. This is a partnership and the investigators need     you for the long haul. The more questionnaires you fill out, the more information the     investigators will have that can help us have a better understanding of why women get breast     cancer.   "
72707|NCT02334072|"     Even though the effects of anesthetic agents both inhalation and intravenous have been well     described, the effect of laryngeal mask airways haven't. The purpose of the study is to     determine the effects of different types of laryngeal mask airways on middle ear pressure.   "
72708|NCT02334059|"     Opioid sparing anesthesia is extremely important in the post-operative obese population. With     more and more obese patients entering the operating room a multi-modal approach to analgesia     is crucial. Finding effective alternatives to opioid therapy is the rationale of this     proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very     sparse.   "
72709|NCT02334046|"     Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually     need smaller doses of anaesthetic drugs than younger patients. The purpose of this study was     to investigate the optimal effect-site concentration of remifentanil for preventing cough     during emergence in elderly patients under sevoflurane and remifentanil anesthesia.   "
72710|NCT02334033|"     Hypertension is an underdiagnosed and undertreated disease in real-life. Blood pressure and     kidney functions are known to be closely related. Increased serum level of Cystatin C, a     sensitive biomarker for renal function, seems to predict adverse cardiovascular events. The     investigators aimed to evaluate the predictive value of serum Cystatin C for control of     hypertension in a community-based study.   "
72711|NCT02334020|"     The purpose of the study is evaluate the effect of the Mental Health First-aid training     course on a Danish population of employees.   "
72731|NCT02333760|"     An open follow up study of patients enrolled in the Phase 1/2 clinical trial of     haematopoietic stem cell gene therapy for the Wiskott-Aldrich Syndrome and treated with     autologous CD34+ cells transduced with the w1.6_hWASP_WPRE (VSVg) lentiviral vector.   "
72732|NCT02333747|"     The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery     in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators     conducted this prospective, randomized, double-blind study to verify the hypothesis that     pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.   "
72736|NCT02333695|"     A medical device for magnetic therapy for spinal cord injuries (SCI) will be disclosed. The     apparatus comprises a combination of several magnets enclosed in a supportive cover. The     magnets are placed in a proper position and their polarity can be changed at any time without     any difficulty.   "
72712|NCT02334007|"     After any surgery, there is a risk of venous thromboembolism (VTE), including Deep Vein     Thrombosis (DVT) in the major veins of the legs and Pulmonary Embolus (PE) in the lungs.     These clots are usually prevented by the administration of low-molecular-weight heparin, a     blood thinner that prevents clotting. In most surgical specialties like thoracic or vascular     surgery, this treatment is used until patients are discharged from the hospital. However, in     orthopaedic surgery, there is strong evidence that longer term preventative treatment up to     35 days after hospital discharge helps to reduce VTE occurrences. In thoracic surgery, there     is an even greater risk of developing PE because of the surgical stress, the common presence     of cancer and direct damage to blood vessels in the lung during surgery. Despite the     potential utility, the use of extended VTE prevention has never been evaluated in the     thoracic surgery population. If extended treatment prevents clots, more patients will avoid     complications related to VTE. There is currently very limited information available on the     incidence of venous thromboembolism (VTE) in patients undergoing lung cancer resection and     the utility of extended thromboprophylaxis (ET) in this patient population. Furthermore, in     contrast to patients undergoing orthopaedic surgery where ET has become standard of care,     duration of thromboprophylaxis is not well defined in this patient population. Therefore,     there is a clear need to systematically evaluate the effects of extended VTE prophylaxis on     the incidence of VTE in the post-op population.   "
72713|NCT02333994|"     The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in     Reducing Fear of Falls in Elderly Population . In the present study the educational program     along with balance training was delivered to group A, (Experimental group) and only Balance     training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly.     Education program included education about the risk factors of falls such as environmental     hazards, importance of good nutrition, use of stick while walking, avoiding slippery     surfaces. Balance training consists of stance activities and balance exercise program. The     outcome measures for this intervention were Activities specific balance confidence scale and     berg balance scale.   "
72714|NCT02333981|"     This study was formulated to determine the efficacy of passive oral motor regimen for     drooling in children with multiple disabilities. Seven subjects aged 7-19yrs were taken in     the study. All the subjects received passive treatment which included light touch, stroking,     vibration, tapping, pressure and stretch. All the techniques have been proved to be effective     in treating drooling. Relative sterility and hygiene was maintained throughout the procedure     as sterilized gloves and napkins were used. The measurement protocol was designed to check     effectiveness on drooling in children. The protocol was given for 4 weeks with treatment     sessions given 3 times per week and the treatment duration was 30min. Twelve sessions of oral     motor stimulation therapy given during the 4 weeks. Thirteen after 4 weeks of treatment,     improvement was found in terms of the severity as well. Primary outcome measure taken was     Drooling Frequency and Severity rating scale and secondary outcome measure being taken was     drool quotient. Pre and post intervention scores of Drooling Frequency and Severity rating     scale and drool quotient were taken and data was analyzed using wilcoxon signed rank test .   "
72741|NCT02333630|"     The investigators aim to study the clinical efficacy of a mobile health application,     AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel     application developed by members of the study team that was previously studied in a pilot     study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was     universal usage and acceptance by all participants of this novel form of technology and     asthma management. This current study aims to measure clinical outcomes for users of the app.   "
72715|NCT02333968|"     Pain is a prevalent and distressing symptom in patients with cancer, having an enormous     impact on functioning and quality of life. Integration of patient self-management and     professional care by means of care technology provides new opportunities in the outpatient     setting. In this project a technology based and nurse delivered multicomponent     self-management support intervention has been developed. Important components include     monitoring, feedback, education, and nurse support. Following feasibility evaluation, the     primary aim of this randomized controlled trial is to assess the effect of the intervention     regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes     of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain     medication use. Besides, a cost-evaluation and summative process evaluation will be     performed.   "
72716|NCT02333955|"     The primary objective of this study is to determine the safety and tolerability of extended     dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease     (CKD).   "
72717|NCT02333942|"     This study is being performed to generate data regarding brain vibration /oscillation     differences between individuals with dementia and normal controls. The purpose of this study     is to compare signal patterns generated from the impact on the scalp from these brain     oscillation patterns from individuals with Alzheimer's disease, Frontotemporal Lobar     Degeneration, Mild Cognitive Impairment and Age-Matched Normal Controls.   "
72718|NCT02333929|"     The objective of the study is to demonstrate the performances of the STA® - Rivaroxaban     Calibrator and STA® - Rivaroxaban Control in combination with the STA® - Liquid Anti-Xa to     determine the quantity of rivaroxaban in plasma samples by measurement of its direct anti-Xa     activity.   "
72733|NCT02333734|"     The overall objective of this study is to examine the blood flow in the thigh muscles and     sugar metabolism before and after 8 weeks of high intensity interval training (HIIT) on a     bicycle ergometer in patients with type 2 diabetes (T2D) and matched controls. The following     parameters are included in the assessment:        -  Sugar Metabolism        -  Muscle and fat mass        -  The blood flow at rest around the thigh muscles        -  Oxygen uptake test on a bicycle ergometer and 5 km time trial   "
72734|NCT02333721|"     The purpose of this study is to explore the short-term, long-term and oncological outcomes of     laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for     advanced middle or upper third gastric cancer.   "
72735|NCT02333708|"     To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in     larger amounts in the blood of patients with histologically proven giant cell arteritis     (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.   "
72719|NCT02333916|"     Rationale: Body weight is not well regulated in all individuals. In an obesogenic     environment, where overeating is common, some individuals are more prone to weight gain and     therefore overweight than others. Yet, the reasons behind this are unclear. Resistant     individuals often have higher physical activity levels (PALs). It seems that - at higher     levels of physical activity and therefore energy expenditure - satiety signals are more     precisely regulated, making one better at matching energy intake with expenditure. In other     words, active people may not overeat where sedentary people would. However, this does not     explain the differences in weight gain observed when subjects all have to overeat (imposed     overfeeding). It could be that active people are better able to cope metabolically with the     extra calories because of already higher levels of carbohydrate and fat oxidation compared to     their inactive counterparts.      Objectives: 1/ To study the effects of overfeeding (normal diet composition) on substrate     balance and oxidation and more specifically fat balance and oxidation; 2/ to study the     effects of exercise and training on fat oxidation during overfeeding (normal diet     composition).      Study design: This controlled intervention study will follow a cross-over design. Each     subject will spend 5 nights and 4 days in a respiration chamber on two occasions, separated     by a 10-week training period.   "
72720|NCT02333903|"     This study compares the ratio of lean mass losses over total body mass losses between     patients undergoing sleeve gastrectomy followed by physical activity training versus patients     undergoing sleeve gastrectomy only   "
72721|NCT02333890|"     Chloroquine (CQ) is a well known, well tolerated medication that has been used for many years     traditionally for arthritis, lupus, and malaria. It has anti-inflammatory properties but is     often the drug of choice for arthritis and malaria due to its few side effects. Recently,     laboratory investigations have proven that CQ may potentially have anti-cancer properties, by     inhibiting a process which allows cancers such as breast cancer to continue to grow (a     process known as autophagy). Therefore, this study will look at how well CQ can inhibit the     growth of breast cancers in patients while waiting for surgery.   "
72722|NCT02333877|"     The purpose of this study is to determine whether suture using the Device of Leukosan     Skinlink is more faster and safer than that of nylon in the treatment of simple wound for     ED patients.   "
72723|NCT02333864|"     The purpose of this study is to determine if the POGO® system delivers accurate blood glucose     readings in the hands of the lay user and assess the POGO® system accuracy when used by     trained health care professionals.   "
72724|NCT02333851|"     Pilot study to compare the efficacy and safety of a premixed-insulin regimen (70%     intermediate insulin and 30% regular insulin) to a basal-bolus insulin regimen (glargine once     daily and glulisine before meals) hospitalized patients with type 2 diabetes.   "
72725|NCT02333838|"     Allogeneic cord blood stem cell transplantation is a potentially curative therapy for     patients with haematological malignancies. We have extensive experience with the use of Cord     Blood Transplantation (CBT) in patients with advanced myeloid malignancies. In adults     however, the 40% Non-Relapse Mortality (NRM) rate observed after CBT conditioned with a     myeloablative conditioning has encouraged the development of CBT with Reduced Intensity     Conditioning (RIC). Our previous national CBT protocol (the Minicord French protocol -     NCT00797758) showed that RIC CBT can reduce NRM, but relapse remains the main post-transplant     event (>30% at one year). Thus, the development of reduced toxicity rather than RIC     conditioning for CBT is warranted in order to improve the outcome of such transplants by     limiting NRM and reducing relapse rate. The Fludarabine, ATG and intensified doses of IV     Busulfan (9.6 mg/Kg total dose) regimen is a well-established preparative regimen for     reduced-intensity/toxicity conditioning prior to allogeneic stem cell transplantation using     peripheral blood stem cells mobilized with G-CSF (ClinicalTrials.gov Identifier:     NCT00841724). However, such regimen is likely not sufficient to allow for CB cell     engraftment. Thiotepa is an alkylating and radio-mimetic agent with a large anti-tumor     activity including leukemic cells, the ability to cross the blood-brain barrier and to     improve engraftment of hematopoietic stem cells. This drug has been combined to usual     conditioning regimen without increasing the toxicity but improving the engraftment rate and     potentially reducing the relapse rate. Thus, in the context of adult CBT for high risk     myeloid malignancies, we propose to prospectively evaluate a reduced toxicity conditioning     based on the association of Thiotepa, Fludarabine, IV Busulfan and ATG with the objective to     achieve acceptable NRM rates, and to allow for improved anti-leukemic control based on the     cytotoxic component of the conditioning regimen itself, while waiting for the long term     immune-mediated disease control (GVL effect).   "
72726|NCT02333825|"     This is a multi-center, randomized controlled clinical trial, the purpose of which is to     determine if patients age 25 and younger who undergo medial patellofemoral ligament (MPFL)     reconstruction have lower rates of recurrent instability compared to those treated     non-operatively. The MPFL is a ligament that stabilizes the kneecap, and maintains its proper     position in the groove on the femur (thighbone). Instability refers to a situation in which     the kneecap moves out of place, or dislocates. When instability is recurrent, it occurs more     than once in the same knee.   "
73504|NCT02323646|"     The primary objective of this study is to determine the safety and efficacy of two vaginal     doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each     separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine     fibroids.   "
72727|NCT02333812|"     Head and neck cancers usually occur in patients who have a history of long tobacco use.     Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways     and lung parenchyma that is also associated with exposure to tobacco. COPD and head & neck     cancer share a common environmental risk factor in cigarette smoke exposure. the     investigators hypothesize that patients with chronic lung disease related to smoking have a     higher risk to develop cancer in the head and neck.      The investigators designed a study to assess the prevalence of cancer and pre-cancer disease     in the head & neck in patients with chronic lung disease. the investigators will examine     patients with and without a history of smoking and chronic lung disease in order to determine     the prevalence of head and neck cancer in the different groups. The patients who will be     included in the study will undergo comprehensive evaluation of their lung function and voice     performance.      This study is a joint effort of the Pulmonology Institute and the Department of     Otolaryngology, Head & Neck Surgery in Israel and the Netherlands.   "
72728|NCT02333799|"     The purpose of this study is to evaluate the efficacy, safety, tolerability and     pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment     (option for 9 months for subjects who remain culture positive at month 4) in Subjects with     either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or     non-responsive multi-drug resistant tuberculosis (MDR-TB).   "
72729|NCT02333786|"     Investigators designed a prospective randomized controlled study to compare the     long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial     catheterization in pediatric patients younger than 5 years old.   "
72737|NCT02333682|"     The investigators are intending to perform a clinical study in healthy subjects on the     pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3     (cholecalciferol) in order to gain insight into the dose response relationship and to assess     kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will     be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin     D3 will be measured throughout the study to assess compliance with the restriction of     exogenous vitamin D supplementation.   "
72738|NCT02333669|"     Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption     through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing     evidence has demonstrated that these lung disorders might be an important cause of neonatal     respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function,     particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might     predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of     SCNN1A are associated with NRDS, we conducted a case-control study to investigate the     NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A     gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).   "
72739|NCT02333656|"     Previous research has shown that the osteoarthritis care for persons with hip or knee     osteoarthritis in Norway has a potential for improvement as the provided care may not     necessarily reflect evidence-based guideline recommendations. This study will determine if a     new model for integrated osteoarthritis (OA) care in primary health care will result in     improved quality of osteoarthritis care and health benefits for the patients (reduced pain     and body weight, increased function and activity level) among patients with hip and/or knee     osteoarthritis. Further, this study will examine if the new model reduce the number of     unnecessary referrals to Magnetic Resonance Imaging (MRI) and to orthopaedic surgeons in     secondary care, and if it increases the number of referrals to physiotherapy treatment and     the number of discharge reports from the physiotherapists to the referring general     practitioner.   "
72740|NCT02333643|"     A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety     and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with     cutaneous warts.   "
72799|NCT02332876|"     Many cancer survivor experience treatment-related impairments in mental abilities such as     memory, attention, and concentration (known as cognition). Research indicates that physical     activity can improve cognition in healthy adults; however, little is known about whether     physical activity can improve cognition among cancer survivors. This study will test whether     a physical activity intervention results in improvements in cognition among breast cancer     survivors, which may lead to interventions to improve cognition.   "
72742|NCT02333617|"     This is a blinded randomized controlled trial to assess the effectiveness of manual therapy     to improve hip abduction strength in patients with acute anterior knee pain.      The primary objective of this study is to see if manual therapy to the gluteus medius can     significantly alter within-session measurements of hip abductor strength in patients with     anterior knee pain.      The secondary objective of this study is to see if manual therapy to the gluteus medius can     significantly alter within session pain in patients with anterior knee pain.   "
72743|NCT02333604|"     The Cancer Support Community's (CSC) Research and Training Institute has created the Cancer     Experience Registry: An Online Initiative to Change the Future of Cancer Care to identify and     understand the emotional and social needs of cancer survivors. Armed with this knowledge, the     investigators will raise awareness about and help develop programs to address the needs of     cancer survivors. Anyone who has ever received a cancer diagnosis, whether recently     diagnosed, in treatment, or years post-treatment can participate. Interested cancer survivors     can register at www.cancerexperienceregistry.org   "
72744|NCT02333591|"     GLP-1 is an agent for treatment of type 2 diabetes and may have protective effects on the     cardiovascular system. The mechanism is complex and there seems to be a dual function with     intact GLP-1 (7-36), acting through the GLP-1 receptor, and the GLP-1 (9-36) metabolite     acting independently of the GLP-1 receptor.      Coronary flow reserve (CFR) is the ratio of flow through the coronary arteries during stress     to during rest and it reflects coronary microcirculation. Impaired CFR is a strong predictor     of poor prognosis of cardiovascular disease.      The aim of the study is to investigate the acute effects of GLP-1 on coronary     microcirculation and endothelial function in adults with obesity.   "
72745|NCT02333578|"     A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease     (EVD) Convalescent Plasma (ECP) for treatment of EVD.   "
72746|NCT02333565|"     To determine if combination of everolimus and octreotide exert an anti-tumoral activity in     recurrent and/or aggressive meningiomas growth with limited adverse effects.   "
72747|NCT02333552|"     Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous     study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in     Indonesian elderly.      This study was aimed to define the risk factors of frailty transitional status and its     correlation with quality of life in Indonesian elderly outpatients.   "
72748|NCT02333539|"     The overall objective of this study is to address the critical need of improving insulin pump     adherence in adolescents with Type 1 Diabetes (T1D) by providing personalized intervention     using evidence-based techniques during routine diabetes clinic visits at point of care.   "
72749|NCT02333526|"     The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from     venous blood of patients with infectious intestinal diseases such as Clostridium     difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or     ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients     with active inflammation and with disease in remission. Secondary objectives were the     assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be     volunteers. Blood will be taken as part of the routine clinical work-up after the written     agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In     addition, the subjects are asked to answer a short questionnaire. The study is designed as a     prospective, comparative cohort study.   "
72750|NCT02333513|"     This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in     patients with recurrent high-grade glioma with IDH1/2 mutation.   "
72751|NCT02333500|"     This prospective pilot study will compare adolescents with restrictive anorexia nervosa who     participated for 3 months at olfactory workshops, patients who did not, and healthy     patients.The groups will be evaluated before the workshops and after three months, with the     wanting score after olfactory stimuli and with serum oxytocin level.   "
72752|NCT02333487|"     The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral     dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.   "
72753|NCT02333474|"     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).     Enrolled patients will receive standard treatment according to National Comprehensive Cancer     Network (NCCN) guide line with or without combining MV injection. The efficacy and side     effect will be compared between the two groups.   "
72754|NCT02333461|"     Excess caloric consumption, particularly from inexpensive, energy dense foods that are high     in fat and refined carbohydrates, is a major driver of the global obesity epidemic. Dietary     supplements that promote reduced intake of energy dense foods and/or impact the absorption     and metabolism of fat and carbohydrates in the body can be used to help consumers control     their weight. We identified two separate mechanistic approaches to target these effects.      Diacylglycerol acyltransferase-1 (DGAT-1) is an enzyme involved in the formation of dietary     fat into circulating triglycerides within the body. Once dietary fat is digested and     absorbed, the resulting fatty acids are re-esterified into triglycerides. Inhibition of     DGAT-1 results in delayed and decreased re-esterification of dietary fats into circulating     triglycerides. It is hypothesized that this effect may lead to decreased deposition of excess     dietary fat as adipose tissue, possibly due to increased fatty acid oxidation in the     enterocytes.      Ghrelin is a hormone that is known to stimulate appetite in humans. When calorie dense fatty     foods are sensed in the stomach, ghrelin is acylated and activated via ghrelin     O-acyltransferase (GOAT). The activation step attaches a medium chain fatty acid to the     ghrelin molecule that enables it to transmit a signal in the brain that triggers eating and     fat storage in adipose tissue. Interfering with the GOAT pathway will inhibit ghrelin     activation and possibly diminish food intake and lipid storage. This concept is supported by     animal studies in which weight gain in a high fat diet model is prevented when GOAT is     inhibited.      Our objective was to determine whether botanicals demonstrating in vitro DGAT-1 and GOAT     inhibition have similar mechanistic effects in the human body. Based on the results of this     study, prototype formulas may be developed and clinically- tested for outcomes related to     weight management.   "
72755|NCT02333448|"     The study consists in taking 4 tubes of blood at different times over a period of 10 days,     via a catheter (central venous or arterial catheter) already in place in the usual     therapeutic management. These samples will make it possible to measure blood levels of     certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load     precisely, that is to say the quantity of yeast present in the blood and to monitor this     quantity over time.      These samples will be transferred to a specialized unit and stored for a maximum of three     years for use at the end of the study.   "
73547|NCT02323087|"     The purpose of this study is to determine whether point-of-care susceptibility testing     improve correct choice of antibiotics, clinical and microbiological outcome in patients with     uncomplicated urinary tract infection in general practice compared to point-of-care urine     culture.   "
72756|NCT02333435|"     Prostate cancer, the most frequently diagnosed cancer among occidental men, is associated     with a major individual and societal burden. Although still controversial, the literature     suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against     prostate cancer. One of the proposed mechanisms of action of ω3 lies in their     anti-inflammatory properties. In addition, there are some observational evidences suggesting     an association of ω3 intake with a lower rate of depression in cancer patients. However, no     clinical study has tested the efficacy of ω3 supplementation on psychological and quality of     life outcomes in that population. Several evidences point to a possible involvement of     inflammation in psychological issues. Reducing the systemic inflammatory state may have     beneficial impact on the quality of life of these patients. Preliminary work from this team     of investigators, in a cohort of patients managed with active surveillance for their     low-grade prostate cancer, show a strong inverse association between the risk of prostate     cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (EPA- a     type of ω3).      HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on     prostate cancer cell proliferation, inflammation and on the patient's psychosocial     functioning and quality of life.      The investigators propose a double blind, randomized controlled clinical trial. 130     consecutive patients suffering from high-risk prostate cancer who choose to be treated by     radical prostatectomy will be eligible to this study. The presence of high-grade cancer will     be mandatory.      The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich     in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before     the prostatectomy and will continue for one year after surgery. The potential confounding     variables will be measured before the start of the intervention: age, anthropometric     parameters, stage and clinical and pathological tumor grade (Gleason score), pre-operative     level of prostate specific antigen and diet.      This project proposes a simple intervention by dietary supplementation that could eventually     help to reduce the incidence and/or progression of prostate cancer, and the consequences of     its treatment, and thus could contribute to diminish the heavy individual and societal burden     of prostate cancer. The clinical data generated by this trial will serve as solid basis for a     large-scale phase III clinical trial.   "
72757|NCT02333422|"     The investigators therefore propose a pilot study to establish the effectiveness of NIRS     Neurofeedback training in reducing the intensity of ADHD symptom expression on children,     improvement of the cognitive and global functions associated with ADHD, effects on cerebral     blood perfusion in the cortex and safety plus possible unknown side-effects.   "
72758|NCT02333409|"     Pancreatic cancer is the sixth most common cause of cancer death in Hong Kong. Patients     suffering from pancreatic cancer are associated with a poor prognosis and survival of less     than one year is expected in inoperable tumours (1). Management of these patients would be     towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this     intractable pain is often difficult to treat (2). Pain management is a major part of the     comprehensive therapy in patients with pancreatic cancer, and it also affects their quality     of life. Electroacupuncture seems to be a promising way to control the cancer pain and reduce     the dose and side effects of pain killers including opioid. This study aimed to investigate     the efficacy and safety of electroacupuncture in reducing pancreatic cancer pain in patients     suffering from inoperable pancreatic cancer.   "
72759|NCT02333396|"     The project seeks to study the use of an navigator-based intervention called PICU Supports.     The study will test the impact of PICU Supports during and after PICU discharge on parent     outcomes (satisfaction with decision making, decision regret, anxiety, depression,     post-traumatic stress, health-related quality of life, and complicated bereavement) and on     parent and healthcare team member assessments of communication and team collaboration.   "
72760|NCT02333383|"     This is a prospective mono-country, multi-center study in Ankylosing Spondylitis (AS)     subjects treated with Adalimumab. At least 200 subjects will be enrolled at approximately 10     sites. The baseline assessment should be performed prior to the first dose of Adalimumab.     Study visit will be conducted at 12, 28, 36 and 52 week after baseline. All subjects will     have one follow-up approximately 70 days after last dose of Adalimumab.   "
72805|NCT02332798|"     This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in     multiple ascending doses in subjects with stable schizophrenia.   "
72761|NCT02333370|"     The purpose of the Phase Ib is to:        1. determine the recommended dose of LEE011 in combination with a standard dose of          letrozole as well as to provide additional safety and anti-tumor activity data in Asian          non-Japanese patients        2. determine the recommended dose of LEE011 in combination with a standard dose of          letrozole as well as to provide additional safety and activity data in Japanese patients        3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the          dose escalation part in combination with a standard dose of letrozole, fulvestrant or          tamoxifen plus goserelin in Japanese patients.   "
72762|NCT02333357|"     This study is developing and testing a 12-step toolkit with five modules, training counselors     to use them, and studying their frequency of use, desirability, effectiveness and patient     outcomes. The toolkit includes counselor written guides, posters, client worksheets,     engagement activities, and videos designed to be shown during substance abuse treatment group     sessions to explain and encourage 12-step participation.   "
72763|NCT02333344|"     It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic     fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after     24-month observation.   "
72764|NCT02333331|"     The purpose of this study is to determine the efficacy of repeat dosing with multiple dose     levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older     adults with sarcopenia. In addition, this study will generate data on the safety,     tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.   "
72765|NCT02333318|"     The objective of this study is to investigate the safety, tolerability and pharmacokinetics     (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older     male volunteers.   "
72766|NCT02333305|"     We propose a study on Ataxia with oculomotor apraxia type 1 (AOA1) in which Coenzyme Q10     (CoQ10) deficit has been observed. Main objectives of the study are :        -  To monitor evolution of albumin in patients affected with AOA1 while supplemented with          CoQ10 ;        -  To measure with clinical scales and biological markers efficacy of supplementation on          disease evolution.      AOA1 is characterised by Hypoalbuminemia. Disease duration is negatively correlated with     albumin level. This study aims to understand mechanisms of the disease and our hypothesis is     that correction or stabilization of albumin level with CoQ10 supplementation could impact     disease evolution. The study is planned from 1 to 2 years supplementation. The CoQ10 is     classified as a food supplement and has already been tested in other neurological conditions.   "
72820|NCT02332603|"     This study evaluates the pathophysiological effects of a single dose of Methylprednisolone     administered prior to total hip- and knee-arthroplasty surgery. The investigators examine the     effect on blood glucose homeostasis.      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will     receive placebo.      The investigators hypothesize that the glucose homeostasis remains equally stable in the     group receiving Methylprednisolone as in the group receiving placebo.   "
72767|NCT02333292|"     Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who     show sustained virologic response (SVR) to treatment including direct-acting antivirals     (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to     determine the frequency of adverse events, including those that are severe and/or cause     treatment interruption, in DAA-based therapy in this setting.      Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the     Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology     (SEIMC).      Study population: HCV-monoinfected patients that initiate DAA-based treatment outside     clinical trials.      Variables: The primary efficacy outcome variable is the proportion of patients who reach     undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety     outcome variable is the percentage of subjects who discontinue therapy due to adverse events.      Statistical analysis: A descriptive study will be performed, as well as a double sensibility     analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment     approach. Those variables that are associated with SVR12 with a p-value <0.2 will be included     in a logistic regression analysis in which SVR12 will be the dependent variable.   "
72768|NCT02333279|"     The investigators will determine the cancer risk in organ transplant recipients compared to     the general population with the help of statistical analysis. Secondly the investigators will     try to characterize the different cancer types.   "
72769|NCT02333266|"     The purpose of this study is to determine whether the newly developed biosensor can be used     to detect and quantify fungal cells in human blood samples.   "
72770|NCT02333253|"     40 patients attending IVF center during 2013 &2014 were fulfilling criteria of poor response     and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or     more. All patients were revised for history, examinations and investigations, including age,     type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.   "
72771|NCT02333240|"     New-onset raised blood pressure (BP) affects about one in ten pregnancies. For some women,     raised BP is an indication of pre-eclampsia: newly arising high blood pressure in pregnancy     combined with protein leaking into the urine. After birth, women's BP remains elevated for a     period of time, but in most cases returns to normal over 2-12 weeks. During this period     medication needs to be adjusted to achieve the correct control. Research suggests that better     BP control during this period is associated with improved long-term health outcomes. The     investigators would like to find out whether home BP monitoring, and self-adjustment of     medications according to an individualised protocol, could improve BP control and patient     satisfaction.      This pilot study has been set up to inform the planning of a large-scale multi-centre     randomised controlled trial by testing the feasibility of the protocol. The investigators     want to increase our experience of applying this management approach in this subset of     patients; to select the most appropriate primary outcome measure and to estimate the effect     size of this intervention; to assess recruitment potential; and to evaluate feasibility of     coordinating this trial across several centres. The primary objective of the large-scale     trial will be to determine whether the self-management approach can improve BP control in     women with medicated hypertensive disorders of pregnancy in the postnatal period.      Women recruited to the study will be randomly assigned to one of two groups: self-management     or usual care. Participants allocated to 'usual care' will have their BP monitored and     medication adjusted by their general practitioner (GP) and midwife as normal. Participants     allocated to the 'self-management' group will use a home BP monitor daily following discharge     from hospital after birth. They will be provided with an individualised schedule for     gradually decreasing their medication(s) in line with their BP readings. Women will be     followed up for 6 months.   "
72772|NCT02333227|"     The hypothesis of the investigators' project is that comprehensive primary preterm birth     prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention),     will reduce the rate of periodontal disease and caries, preterm birth prevalence, and     neonatal mortality.   "
72773|NCT02333214|"     Frailty is a highly prevalent condition, reaching approximately 7% to 30% of older adults     aged from 65 up to 80 years [2]. Although exercises seemed to be beneficial for the frail     elders, there is still insufficient evidence to indicate the appropriate modality, frequency     and intensity of physical exercises that were able to improve physical functioning in this     population [9]. The virtual reality (VR) using interactive games (exergames) have generated     broad scientific and clinical interest in recent years[10]. Studies indicate that older     adults can benefit from training with exergames in improving mobility [12, 13], lower limb     strength [14], cognition, particularly executive function [13], body balance [10, 15-18],     reaction time [12] and may contribute indirectly to prevent falls [10, 19, 20]. But, there is     still insufficient evidence to suggest that the use of exergames are superior even to other     types of intervention [21-23] or in combination with conventional physiotherapy [24] The     purpose of this study is to investigate the effectiveness of adding exercises using     interactive videogames (exergames) in improving physical functioning on frail and pre frail     older people when compared to conventional physiotherapy. A parallel randomized clinical with     a 6 month follow-up period will be conducted with 82 frail community dwelling older adults.     Participants randomized to the Experimental Group will be submitted to 30 minutes of     conventional physiotherapy and 20 minutes of therapy using interactive games Xbox 360 Video     Game and Entertainment Microsoft System with Kinect sensor.      The Control Group will receive 50 minutes of conventional physiotherapy. Both groups will     receive 50 minutes of intervention twice a week for 12 weeks. Primary outcomes will be     assessed by the Short Physical Performance Battery, the Usual walking speed test and Four     Step Square Test in the baseline, 3 and 6 months after that.   "
72774|NCT02333201|"     Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients     (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition,     prolonged enteral tube feeding and increased risk of aspiration. In the present observational     analysis, the investigators aim to elucidate the incidence and the impact of dysphagia on the     clinical course of a mixed population of ICU patients post invasive mechanical ventilation.   "
72775|NCT02333188|"     This phase I/II trial studies the side effects of genetic analysis-guided dosing of     paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and     irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer that     has spread to other parts of the body and usually cannot be cured or controlled with     treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Genetic analysis may help doctors     determine what dose of irinotecan hydrochloride patients can tolerate.   "
72884|NCT02331771|"     This randomized, placebo-controlled trial will evaluate the use of donepezil compared to     placebo to reduce the risk of memory impairment after electroconvulsive therapy (ECT).   "
72885|NCT02331758|"     The purpose of this study is to explore the factors which affect ovarian response of PCOS     patients with IVF-ET treatment, in order to provide predictive clinical index for the outcome     of IVF-ET treatment in PCOS patients. After figuring out the controllable factors,     researchers would be able to educate PCOS patients and improve the success rate while     reducing the incidence of complications during the treatment at the same time.   "
72776|NCT02333175|"     The aim of this project is to evaluate the needs and provision of care for patients in the     late stages of Parkinsonism and their carers in several European countries, to compare the     effectiveness of different health and social care systems, and to lay the foundation for     improved outcomes in this population. The investigators will undertake an in-depth assessment     of patients and their care arrangements in a population recruited through networks in six     European countries. The systems and procedures that are used in the provision of care will be     reviewed through a systematic literature review, interviews and assessments of patients,     carers and health care providers, and through a trial comparing assessment by a specialist     with management suggestions, guidance and access to telephone advice to that of usual care.     Through interviews, questionnaire assessment and review of current health-care and social     care arrangement, the investigators will assess the needs, provision of care and use of     health-care resources, and their impact on patient and carer outcomes in different countries.     National and regional databases will also be interrogated to identify current practice and     use of healthcare resources and drug usage. A systematic literature review of the evidence     for effective management strategies, analysis of the study data, and evaluation of change in     outcomes following specialist review will provide the basis for recommendations in the     management of late stage Parkinsonism. The investigators will also evaluate potentially     useful outcome measures for use in this patient group. In addition to charting the needs and     current care provision for late stage Parkinsonism in different European countries, its cost     and effectiveness, and an analysis of health-care and social care predictors of improved     outcome, the project will produce a platform for the assessment of patients with late stage     Parkinsonism, their current treatment and care provision, as well as guidelines on the     management of this late disease phase.   "
72777|NCT02333162|"     This phase I trial studies the side effects and the best dose of intensity modulated total     marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in     treating patients with cancers of the blood (hematologic) that have returned after a period     of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of     radiation therapy to the bone marrow that may be less toxic and may also reduce the chances     of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem     cell transplant may help stop the growth of cells in the bone marrow, including normal     blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are     infused into the patient they may help the patient's bone marrow make stem cells, red blood     cells, white blood cells, and platelets.   "
72778|NCT02333149|"     This study is a multi-center, randomized, triple-blind, placebo-controlled parallel-group     trial, in which each participant is offered an N-of-1 trial. The purpose of this study is to     assess the efficacy and safety of melatonin (3 mg or 6 mg) compared with placebo for initial     insomnia in children with attention-deficit disorder.   "
72779|NCT02333136|"     The LighTouch device shines imperceptible red light into the skin and measures the light that     comes back out using the method of Raman Spectroscopy. Some of this light is color shifted     and some is not. Using a proprietary numerical recipe, the LighTouch device combines the     signals in this remitted light and calculates hematocrit, glucose, protein and potentially     other analytes. Thus the LighTouch device produces information without painful physical     insult to the patient and can trend changes in these blood analytes in order to predict the     need for intervention.   "
72780|NCT02333123|"     This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer     healing. The study also examines whether patients can be recruited to a larger study.     Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer     community clinics or hospital out-patient clinics, or registered with a clinic but are     receiving care at home will be recruited. All patients will receive standard compression     bandaging. Half of the participants will be randomised to receive aspirin, while the other     half will receive a placebo.   "
73104|NCT02328898|"     The study objective is to assess the safety and efficacy of the Permanent Polymer     Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent     Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration will     be applied in stable angina pectoris patients. Myocardial infarction patient population will     be treated with 12 months of dual antiplatelet therapy.   "
72781|NCT02333110|"     Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General     Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors,     radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the     tumor size, tumor location and tumor pathology. However, for many patients this treatment     involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated     radiation (SFR) is an alternative technique that consists in delivering one single treatment,     given through a grid containing holes. The present study is proposing to validate SFR as a     safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm)     or with tumors known to be resistant to radiation.   "
72782|NCT02333097|"     Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy     in case of fetal polymalformation in order to assess significant genomic alterations.     However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated     congenital heart defect.      This is the first prospective study aiming at defining the right chromosomal screening when a     fetal isolated congenital heart defect is identified by ultrasound.   "
72783|NCT02333084|"     This is a randomized, placebo controlled study. The first subject is expected to be enrolled     in July 2014, and the last subject is expected to complete the study by July 2015. Each     subject will be provided with the PRN Joint Comfort Formula, placebo or PRN Flex Omega     Benefits® combination depending on randomization (1:1:1 at each site) during the course of     the study. Instructions and frequency of use will be determined by the labelling.   "
72784|NCT02333071|"     A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an     Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered     subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without     decreased arousal) in premenopausal females.   "
72785|NCT02333058|"     The primary goal of this study is to evaluate an alternative myeloablative, but reduced     toxicity conditioning regimen in children, to describe the safety and efficacy of intravenous     (i.v.) Treosulfan administered as part of a standardised Fludarabine-containing conditioning     and to contribute to the current pharmacokinetic model to be able to finally give age (or     body surface area) dependent dose recommendations. The treatment regimens given in the     protocol MC-FludT.17/M are based on sufficient clinical safety and efficacy data. Considering     the vital indication for allogeneic haematopoietic stem cell transplantation of the selected     patient population, the risk-benefit assessment is therefore reasonably in favour of the     study conduct.   "
72786|NCT02333045|"     This study seeks to understand the immune cells in the cervical fluid of in the blood and     genital tract of HIV-negative healthy female volunteers and to see if these cells can be     modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine     used in the treatment of HIV infection.   "
72787|NCT02333032|"     The main objective of this study is to determine if a single session of treadmill training     with a positive slope improves the kinematic parameters of the hip, knee and ankle on the     paretic lower limb.      Secondarily we will quantify the efficiency of a such training on kinetic and functional     parameters.   "
72788|NCT02333019|"     While the U.S. teen birth rate is currently at its lowest level, it remains high in relation     to other industrialized countries and continues to be a public health concern due to health     risks for teen mothers and their babies, and associated social and economic costs. Parental     monitoring, supervision, and open communication about sexual issues have been found to be     protective factors for adolescent sexual activity and pregnancy. Our theoretically based     Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is     designed to build parental communication, knowledge, and attitudes to discuss sensitive     topics with their child, including sexuality, pregnancy prevention, and preventing sexually     transmitted illnesses (STIs). This age group of children was selected because parental     communication about pregnancy and STI prevention will be most effective if initiated prior     to, rather than after, the age when children commonly become sexually active. The Let's Talk     about Sex program is grounded in behavior change theory and incorporates the use of video     for behavioral modeling and emotional support.   "
72789|NCT02333006|"     This study is conducted over 18 months. The main objective of this study is to test and     compare the relevance and reliability of different tools for measuring the anosognosia.      Secondary objectives are :        -  identify the relevant test who are able to evaluate more specially the cognitive          processes involved in anosognosia        -  explore the links between the anosognosia manifestations and the psychological          manifestations   "
72790|NCT02332993|"     The purpose of this study is to examine the changes that result in the wound healing of a     type II Diabetic using Negative Pressure Therapy after 12 weeks of daily supplementation of     ImmunAge (Fermented Papaya Preparation (FPP). ImmunAge (FPP) is a supplement made from Carica     papaya Linn and is available over the counter. ImmunAge (FPP) is an investigational drug,     which means it has not been approved by the U. S. Food and Drug Administration (FDA).     Approximately 30 subjects will participate in this study. 15 subjects will take the     supplementation and 15 subjects to take no supplementation as the control. The   "
72791|NCT02332980|"     This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib     works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell     non-Hodgkin lymphomas that have returned after a period of improvement or have not responded     to treatment. Monoclonal antibodies, such as pembrolizumab, block cancer growth in different     ways by targeting certain cells and allow the immune system to attack the cancer. Idelalisib     and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving pembrolizumab alone or with idelalisib or ibrutinib may be an effective     treatment in patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin     lymphomas.   "
72792|NCT02332967|"     The primary objective of this trial is to demonstrate that infants receiving an infant     formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the     first 4 months of life, stools that are softer than those of infants receiving a control     formula.   "
72793|NCT02332954|"     The purpose of the study is to describe the association/correlation between change in     patient-reported cognitive symptoms and work productivity in gainfully employed patients     receiving vortioxetine for a Major Depressive Episode (MDE).   "
72794|NCT02332941|"     The purpose of this study is to determine if treatment of Age Related Macular Degeneration     (AMD) with a new medication,rituximab is effective. To address this issue, investigators     propose a clinical trial in which patients with late stage disease, poor vision and who have     failed treatment by conventional means will receive rituximab by direct injection into the     affected eye and will be followed for improvement in the structure of their retina. Age     Related Macular Degeneration (AMD) is a leading cause of vision loss in the elderly with     routine care involving injections in the eye to improve and to prevent worsening of vision.     However, some patients do not respond to the medications that we currently have and as such     an alternative medication is needed. One potential medication is rituximab, which has been     injected into the eye for primary eye cancer, and has been tolerated well and led to patient     improvement. Investigators will obtain baseline eye tests then plan on injecting this     medication in to the eye of our patients with late stage AMD, by first placing numbing drops     into the eye, then injecting the medication directly into the eye using sterile techniques.     Investigators will then follow the patient and repeat eye tests to monitor for improvements.   "
72795|NCT02332928|"     This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be     randomized to receive either 20 mg oral melatonin or placebo the night before their first RT,     nightly throughout their RT, and for an additional 2 weeks following the completion of their     RT. After informed consent is obtained from eligible subjects, they will then be     electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects will     be stratified according to treatment duration (less than 3 weeks; equal to or greater than 3     weeks) and prior chemotherapy.   "
72796|NCT02332915|"     A growing neurorehabilitation literature suggests that intense treatment may be desired to     maximize the effects of therapy following neurologic injury. This investigation is designed     to facilitate the development of efficacious, clinically applicable treatment for acquired     apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week     vs. 3 hours per week, while holding total number of sessions constant) with a group of     speakers who have chronic apraxia of speech and aphasia.   "
72797|NCT02332902|"     This trial is evaluating the use of oral Everolimus to determine if there is a reduction in     the size of the disfiguring cutaneous lesions in patients with Neurofibromatosis 1 over a 6     month period. The evaluation will be done by 3D photography measuring volume with the LIFEVIZ     Micro system.   "
72798|NCT02332889|"     The main purpose of this study is to determine the safety of using the combination of     decitabine and a cancer vaccine plus Hiltonol. The vaccine will be made from the subject's     blood cells and is designed to interact in the subject's body with cells that are programmed     to fight specific tumor proteins called NY-ESO-1, MAGE-A1 and MAGE-A3. The decitabine will be     given to increase the amount and activity of these cancer proteins on the surface of tumor     cells to increase the possibility that the vaccine will stimulate cells to act against the     tumor cells. Subjects will be assessed to determine how these tumors respond to the     treatment.   "
78335|NCT02260544|"     Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are     already receiving or who in the opinion of their treating physicians are candidates for     Doxorubicin liposomal injection therapy .   "
72800|NCT02332863|"     Endoscopic ultrasound (EUS) has been pivotal in accomplishing image guided radiation therapy     (IGRT) in patients with pancreatic cancer by allowing precise contouring and identification     of target lesions in the pancreas via placement of fiducials using fine needle aspiration     (FNA) needles. Currently, back-loading the fiducials is the only option for preparing     delivery of fiducials via the EUS approach. A prototype 22-Gauge EUS needle preloaded with     four fiducials has recently been developed, and used in a porcine models with successful     results. There are no randomized controlled trials comparing total duration of time needed     for placement of fiducials using technical success of the traditional back- loading technique     of fiducial markers to the new preloaded needles in regards to EUS based fiducial marker     placement for IGRT in pancreatic cancer.      Hypotheses      Use of a 22 G preloaded needle for EUS guided fiducial marker placement in patients with     pancreatic cancer will:        1. Be delivered in at least require 60% less of the procedure time that it takes for          traditional back-loaded 22G needles        2. Improve overall procedure efficiency        3. Maintain comparable technical success and adverse event rates.      Primary Aims      1) To compare the procedure time of 22G needle placement of three Visicoil (brand of flexible     linear back-loaded fiducial markers) fiducial markers and 22G needle preloaded fiducial     markers.      Secondary Aims        1. To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and          22G needle preloaded fiducial markers        2. To compare endpoints of technical success defined as proper placement of two to three          fiducial markers in a pancreatic neoplasm in 22G needle placement of Visicoil fiducial          markers and 22G needle preloaded fiducial markers.   "
72801|NCT02332850|"     This study will be conducted as a standard Phase 1b, open-label, multi-center study of     patients with relapsed and/or refractory Myeloma who have received at least two prior     therapeutic treatments or regimens. Throughout the Phase I portion of this study, a standard     3+3 dose escalation design will be utilized. Two dosing cohorts will evaluate escalating     doses SAR650984 (5mg/kg and 10 mg/kg Day 1 and 15 of each 28-day cycle) with standard dose     Carfilzomib (20-27 mg/mg2). Once a safe dose is established, an expansion cohort will further     evaluate safety and begin to assess activity of this combination (SAR650984 (5mg/kg or 10     mg/kg Day 1 and 15 of each 28-day cycle) with standard dose Carfilzomib).      During the dose escalation portion of the study, the DLT period will be the first cycle (28     days) or from Day 1 through Day 28 of initial study treatment.      Expansion Phase Cohort An expansion cohort will begin once the MTD of SAR650984 plus standard     dose Carfilzomib is established. The Expansion Cohort will enroll 18 patients for additional     safety and preliminary efficacy data of SAR650984 plus Carfilzomib at the MTD.   "
72802|NCT02332837|"     Online trials require informed consent from participants. Massive online trials make     face-to-face signed consent unrealistic and existing consent comprehension could be improved     to increase participant safety and understanding.      This trial will compare understanding of traditional digital consent with multi-media consent     and with consent that is multi-media and interactive and uses a test and train model.      The computer will assign participants to 1 of 3 methods to present online consent to     participants   "
72803|NCT02332824|"     The primary objective of this study is to test the efficacy and safety on daily oral doses of     TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and     microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison     in order to determine the clinical dose of TAK-272.   "
72804|NCT02332811|"     Primary Objective:      Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer     carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD)     patients both on haemodialysis and not on dialysis      Secondary Objective:      Evaluate the safety on the basis of adverse events, changes in laboratory values and vital     signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)   "
72806|NCT02332785|"     With this study, the investigators plan to review the clinical, epidemiology, pathology, and     endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of     these lesions. The findings will help us define the natural history of colon serrated     lesions, develop techniques for endoscopic management of patients with serrated lesions, and     identity areas for improvement. The data will be used for continuing quality improvement and     presenting our outcomes at academic meetings and publishing our results in peer reviewed     journals.   "
72807|NCT02332772|"     With this study, the investigators plan to review the performance of colonoscopic resection     of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role of     colonoscopic resection of colon polyps and flat lesions and identity areas for improvement.     The data will be used for continuing quality improvement and presenting our outcomes at     academic meetings and publishing our results in peer reviewed journals.   "
72808|NCT02332759|"     The Materna device aims to prevent pelvic tissue damage by preventing overstretching of     pelvic floor muscle fibers during delivery. The device is a single use, disposable,     mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually     expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a     delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of     labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of     trained clinical labor and delivery providers   "
72809|NCT02332746|"     The purpose of this study is to explore temporal relationships between self-worth and     physical activity (PA) participation in middle-aged women (aged 35-64 years). We are     particularly interested in the predictive role of self-worth on women's daily PA     participation.      This study will include two phases: a pilot phase to test the procedures and a test phase to     assess self-worth and PA. During the test phase, Women will receive text message prompts in     the morning, afternoon, and evening for 28 days on their cell phones. Each prompt will     include a link to an 11-item mobile Internet-based survey assessing momentary PA, self-worth,     and self-efficacy. Women will also concurrently wear an activity monitor (GENEActiv) to     objectively measure their activity levels throughout the study.   "
72810|NCT02332733|"     The purpose of this study is to evaluate the safety of and immune response to two doses of a     dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in     Thailand.   "
72886|NCT02331745|"     This study evaluates the Granulocyte colony-stimulating factor (G-CSF) in the treatment of     Acute on Chronic Liver Failure in adult. Half participants will receive G-CSF and standard     treatment in combination, while half participants will receive standard treatment.   "
73073|NCT02329301|"     To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with     DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD     malaria case incidence and cohort infection incidence in areas of high and low malaria     transmission and in a program-relevant manner that will permit adoption and adaptation for     wider-scale deployment.   "
72811|NCT02332720|"     This is a randomized, three-part, parallel-group, open-label trial of grazoprevir (MK-5172)     (100 mg) and Uprifosbuvir (MK-3682) (300 mg or 450 mg) with either elbasvir (MK-8742) (50 mg)     or ruzasvir (MK-8408) (60 mg), and with and without ribavirin (RBV), in treatment-naive (TN)     or treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) participants infected with     hepatitis C virus (HCV) genotype (GT) 3, GT4, GT5, or GT6. Part A will consist of 4 arms to     evaluate the safety of dose combinations. In Part B, participants will take 2 uprifosbuvir     (+) grazoprevir (+) ruzasvir (MK-3682B) fixed dose combination (FDC) tablets once daily     (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based     dosing). Participants who relapse following completion of therapy in Part A will be offered     the option of retreatment with 16 weeks of uprifosbuvir (+) grazoprevir (+) ruzasvir with RBV     in Part C (data obtained from Part C will not be used in the analysis of outcome measures).   "
72812|NCT02332707|"     This is a randomized, three-part, open-label trial of grazoprevir (MK-5172) (100 mg) and     uprifosbuvir (MK-3682) (300 mg or 450 mg), with either elbasvir (MK-8742) (50 mg) or ruzasvir     (MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naïve (TN) and     treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV)     participants with chronic HCV genotype (GT) 1 or GT2 infection. Part A will consist of 8 arms     to evaluate the safety of dose combinations. In Part B, participants will take 2 uprifosbuvir     (+) grazoprevir (+) ruzasvir fixed dose combination (FDC) tablets once daily (q.d.) by mouth,     with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants     who relapse following completion of therapy in Part A will be offered the option of     retreatment with 16 weeks of uprifosbuvir (+) grazoprevir (+) ruzasvir with RBV in Part C     (data obtained from Part C will not be used in the analysis of outcome measures).   "
72813|NCT02332694|"     Fibromyalgia has become an increasingly pressing public health problem in the United States.     Although some treatments exist for Fibromyalgia, many individuals suffering with Fibromyalgia     do not adequately respond to currently available treatment options, highlighting the need to     develop and test new interventions for the disorder. To address this pressing clinical issue,     we will conduct a pilot study to determine if Whole Body Hyperthermia (WBH) reduces symptoms     in adults suffering from Fibromyalgia. We plan to recruit individuals with Fibromyalgia who     will receive a single session of WBH to determine if this single session improves     Fibromyalgia symptoms and if so whether this improvement will last at least 2 weeks. To do     this, the study will include self-report symptom assessments immediately before and one and     two weeks after WBH. In addition blood will be collected at these time points to explore     whether WBH changes immune system chemicals that are believed to contribute to fibromyalgia.     We intend to conduct the study until 10 individuals with fibromyalgia have received a single     treatment of WBH and have completed all pre-treatment and post-treatment assessments. Given     scientific evidence from our research group that WBH may improve depression, we anticipate     that it may also be of benefit or adults suffering from Fibromyalgia.   "
72850|NCT02332213|"     The study is aimed to determine the potential of volatile marker testing for identification     of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related     precancerous lesions in the stomach and colon.      The study will be addressing the role of confounding factors, including lifestyle factors,     diet, smoking as well as addressing the potential role of microbiota in the composition of     exhaled volatile markers.   "
72814|NCT02332681|"     Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural     deterioration of bone tissue with consequent bone fragility and susceptibility to fracture.     Fifty percent of women and 20% men older than 50 y.o. will have an osteoporotic fracture     (fragility fracture). Fragility fracture is defined as one that results from a low-energy     trauma such as a fall from body height. A previous fracture is an important predictor of a     new fracture, especially in the first 5 years after initial fracture. A second fracture can     be particularly devastating if it is a hip fracture. Low bone mineral density, measured by     bone densitometry, as well as a previous osteoporotic fracture, are the two major risk     factors for the occurrence of a new fracture.      A more rational approach currently used to minimize the costs of health care in a shorter     period of time uses the strategy of firstly preventing the occurrence of secondary fracture,     followed by primary prevention strategies. In this context, correct identification of     fragility fractures and consequent treatment of those individuals is imperative. There are     currently insufficient data about the epidemiology and evolution of other fragility     fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius     fracture and proximal humerus fractures are the most frequent. There is a type of fracture,     however, that is simply ignored by the medical community: the knee insufficiency fracture.A     possible explanation for this information gap could be the fact that, until a few years ago,     this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming     clear that the cause of pain and marrow bone edema that occur subtly in older individuals is,     in fact, a insufficiency fracture. The perception that this lesion is actually a fracture is     relatively new. The knee insufficiency fracture usually occurs in older individuals and those     with knee osteoarthritis. This study therefore aims to evaluate whether there is a relation     between knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if     this fracture may be defined as a fragility fracture, electing the individuals affected by it     to a prophylaxis for the occurrence of new osteoporotic fracture.   "
72815|NCT02332668|"     This is a 2-part study of pembrolizumab (MK-3475) in pediatric participants who have either     advanced melanoma or a programmed cell death ligand 1 (PD-L1)-positive advanced, relapsed or     refractory solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose     (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2     dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy     at the pediatric RP2D.   "
72816|NCT02332655|"     The purpose of this study is to determine the tolerability and optimal dose of cannabidiol     (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome     (SWS) and drug resistant epilepsy.   "
72817|NCT02332642|"     This pilot clinical trial aims at evaluating immuno-modulating effects of palliative     treatment with specifically dosed standard chemotherapeutics in patients with metastatic     melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and     activity.   "
72818|NCT02332629|"     This study evaluates the pathophysiological effects of a single dose methylprednisolone     administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the     effect on the endothelial glycocalyx shedding due to surgical trauma.      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will     receive placebo.      The investigators hypothesize that the group receiving methylprednisolone will experience     reduction in glycocalyx degradation compared to the placebo-group, early after TKA.   "
72819|NCT02332616|"     This study evaluates the pathophysiological effects of a single dose of methylprednisolone     administered prior to total knee-arthroplasty surgery. The investigators examine the effect     on complement activation.      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will     receive placebo.      The investigators hypothesize that the group receiving methylprednisolone will experience     beneficial inhibition of the undesirable parts of the complement activation.   "
73991|NCT02317263|"     This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II     clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96     weeks duration on whole brain atrophy in men with MS.   "
72821|NCT02332590|"     Primary Objective:      To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect     to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte     sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were     either intolerant of, or considered inappropriate candidates for continued treatment with     methotrexate (MTX), or after at least 12 weeks of continued treatment with MTX, were     determined to be inadequate responders.      Secondary Objectives:      To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in     participants with active RA who were either intolerant of, or considered inappropriate     candidates for continued treatment with MTX, or after at least 12 weeks of continued     treatment with MTX, were determined to be inadequate responders, with respect to:        -  Reduction of signs and symptoms of RA.        -  Improvement in quality of life assessed by participant reported outcome questionnaires.      Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity)     throughout the study.   "
72822|NCT02332577|"     Primary Objective:      To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g     x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the     end of treatment.      Secondary Objectives:      To evaluate the clinical efficacy in a subpopulation bacteriologically documented at     inclusion and according to procalcitonin level.      To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse     and mortality 30±2 days after treatment is started.      To document failures. To collect and follow up adverse events.   "
72823|NCT02332564|"     CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES Despite considerable advances in     medicine, cardiovascular diseases remain the number one cause of death globally. In     industrialized countries, coronary artery disease (CAD) is the leading cause of death,     consequence of myocardial infarction (MI). Artificial - or natural - bypasses exert a     protective effect by providing an alternative source of blood flow to a myocardial territory     potentially affected by an acute coronary occlusion. Coronary collaterals represent     pre-existing inter-arterial anastomoses and as such are the natural counter-part of     surgically created bypasses. In patients with chronic CAD, sufficient coronary collaterals     have been shown to confer a significant benefits in terms of overall mortality and     cardiovascular events.      EXTRACARDIAC-TO-CORONARY COLLATERAL SUPPLY Commonly, coronary collaterals are implicitly     understood to exist between coronary artery branches. However, the structural existence of     coronary collaterals with an extracardiac connection has been confirmed by anatomical     investigations. Pathophysiologically and with regard to a potential for arteriogenic     stimulation, the connections from the internal mammary arteries, are of special interest.      In a recently published work the investigators have investigated the effect of temporary     balloon occlusion of the distal IMA on coronary collateral function. There were equivocal     findings for the left circumflex coronary artery: CFI was increased by ipsilateral IMA     occlusion, but the level of myocardial ischemia was unchanged.      MYOCARDIAL STEAL VIA INTERNAL MAMMARY ARTERIES In the investigators' previous study, the     coronary occlusion with simultaneous distal IMA occlusion was always performed first as a     conservative measure against false-positive detection of internal-mammary-to-coronary artery     connections. Repetitive coronary occlusions per se result in higher collateral flow by     collateral recruitment and reduced ischemia by ischemic preconditioning and augmented     collateral function. Conversely, the sensitivity of the employed method was reduced and might     have contributed to the equivocal findings in case of the left circumflex artery. Moreover,     the hypothesize d mechanism of localized pressure augmentation was not investigated.      This study aims to further characterize the prevalence and function of natural ipsilateral     IMA-to-coronary connections, as well as to investigate the hemodynamic mechanisms of coronary     collateral function augmentation by distal IMA occlusion. In the investigators' last study,     the increased coronary collateral function in response to manipulation of a potential     coronary collateral donor (in this case, the IMA) was taken as indirect evidence for the     existence of IMA-to-coronary-artery connections. Thus, the employed distal IMA occlusion     served as a positive stimulus. Conceptually, additional evaluation with a negative stimulus     could heighten the discriminatory power of the investigation. This could be in the form of a     hyperemic stimulus affecting the collateral donor, ie in analogy to myocardial or coronary     steal (ie, a reduction in coronary collateral supply to a collateral recipient).   "
72824|NCT02332551|"     The purpose of this study is to investigate the safety and efficacy of irreversible     electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress     Free Survival (PFS) will be recorded.   "
72825|NCT02332538|"     Most guidelines are not strict for recommending single treatment approach for Moderate to     large prostate.      In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective     Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar     transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate     (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective     randomized trial.   "
72826|NCT02332525|"     The purpose of this study is to investigate the effect of oral vibratory stimulus on the     brain activity and cognitive function of elderly people with non-dementia subjects (cognitive     normal, mild cognitive impairment)   "
72892|NCT02331667|"     The main aim of this intervention study is to test the effect of diet on improvement in     cognitive performanc in kindergarden children aged 4-6 years. Children will be randomly     allocated into two groups, one consuming prepared meals with herring or mackerel for four     months, and one group consuming meals containing meat as a control group.   "
72827|NCT02332512|"     Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2)     tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and     phase II clinical studies and found its promising anti-tumor activity and tolerable     toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib     phase II study in patients with NSCLC.      The study aims to compare the efficacy and safety of apatinib to placebo in advanced     non-squamous non-small cell lung cancer patients.   "
72828|NCT02332499|"     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in     patients with metastatic colorectal cancer refractory to standard chemotherapies.   "
72829|NCT02332486|"     Due to the change of life style, the incidence of oral cavity mucous membrane disease     increased.In this study，been done a large number of pre-clinical practice and some     experimental studies， based on the application of metabolomics technology to ultra-high     liquid-mass spectrometry metabolomics analyzer as the core means， The metabolism of pattern     recognition and combination of modern analytical techniques to measure blood and urine of     patients with OLP-specific clearance of endogenous metabolites，and after the intervention of     moss drink endogenous metabolites in the body as a whole group of. At the same time， the use     of flow cytometry,，ELISA， immunohistochemistry and other modern technology, research OLP     patients using clean moss drink before and after treatment of local lesions and peripheral     blood CD4 +，CD8 + lymphocytes，Th1 cytokines (IFN-γ， TNF-α)， Th2 cytokines (IL-4，10) the     dynamic changes. From metabolomics， cellular immunology， inflammation mechanism perspective     of local OLP lesions， peripheral blood and changes in endogenous metabolites in the     process,，in-depth study of traditional Chinese medicine to drink clean moss multi-component     multi-target treatment of this disease mechanism， is widely used in traditional Chinese     medicine treatment of OLP provide a theoretical basis for the promotion of Chinese medicine     Qingxian Yin in the oral mucosal disease in the application， effectively solve clinical     practice problems.   "
72830|NCT02332473|"     This study is a multi-center, randomized, prospective open-label study to assess the efficacy     and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in     interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized     to one of the 2 groups to receive different antiviral treatment.   "
72831|NCT02332460|"     Infliximab is the active ingredient in a drug currently sold by the trade names Remicade,     Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical     messenger (cytokine) in the immune system, and belongs to a class of drugs called TNF     inhibitors. 8-55% of patients receiving infliximab have an infusion reaction. Infusion     reactions are unintended reactions that occur during infusion of the drug and up to 14 days     after. The incidence varies widely in different studies and seems difficult to determine due     to variations in reporting of reactions, different definitions of reactions and retrospective     data collection. The aim of this study is to estimate the incidence of infusion related     reactions and investigate risk factors and immunological mechanisms of infusion reactions to     infliximab in patients with a chronic inflammatory disease.   "
72832|NCT02332447|"     Sudden unexpected death in epilepsy (SUDEP) primarily affects young adults with     drug-resistant epilepsy, with an incidence of about 0.4%/year. The diagnosis of SUDEP     requires that anamnestic data and post-mortem examination do not reveal a structural or     toxicological cause for death. Generalized tonic-clonic seizures (GTCS) are the main risk     factor for SUDEP, which they appear to trigger in most instances. Indeed, experimental and     clinical data strongly suggest that most SUDEP result from a postictal respiratory     dysfunction progressing to terminal apnea, later followed by cardiac arrest.      Postictal apnea could partly derive from a seizure-induced massive release of endogenous     opioids. Animal studies suggest that such seizure-related release of endogenous opioid     peptides participate to termination of seizures. In patients with epilepsy, functional     imaging studies have confirmed that seizures induce release of endogenous opioids. The     brainstem respiratory centers contain the highest density in opioid receptors, accounting for     respiratory depression being one of the cardinal symptoms of opioid overdose.      The investigators hypothesis is that SUDEP partly results from a post-ictal apnea promoted by     a GTCS-induced massive release of endogenous opioids, and that an opioid antagonist could     represent an effective preventive treatment of SUDEP. This could be achieved by chronic     administration of Naltrexone, an opioid antagonist that has been used in a large population     of patients with chronic alcoholism at high risk of seizures, without showing any     pro-convulsant effect. This is a crucial feasibility issue since antagonising a mechanism     thought to participate to seizure termination could theoretically aggravate seizures.      Before evaluating the efficacy of chronic administration of naltrexone, it is legitimate to     perform a proof of concept study by testing the acute effect of an equivalent injectable     treatment (Naloxone) in the immediate aftermath of GTCS recorded inhospital during video-EEG     monitoring of patients with refractory epilepsy. One third of these patients develop     postictal respiratory dysfunction and hypoxemia, which should be reduced by the investigators     intervention if the investigators hypothesis is correct.      The main objective of the study is to evaluate the efficacy of 0.4 mg intravenous naloxone,     versus placebo, administered in the immediate aftermath of a GTCS, in reducing the severity     of the postictal central respiratory dysfunction occurring after the end of the seizure, as     measured by pulse oximetry.      About 25% of patients with drug-resistant partial epilepsy who undergo long-term video-EEG     monitoring develop at least one partial secondary generalized tonic-clonic seizure. However,     these patients cannot be individualized a priori. Therefore, all adult patients with     drug-resistant epilepsy who will undergo long-term video-EEG monitoring in one of the     participating centres, will lack all exclusion criteria, and will give their written informed     consent to participate to the study if they develop GTCS, will be included in the study. They     will all benefit from continuous monitoring of pulse oximetry (together with video, EEG, and     respiration recordings), and will be equipped with a peripheral venous catheter throughout     the video-EEG. The modalities of the video-EEG monitoring will be consistent with the current     practices and similar across the 14 centres (apart from the venous catheter which is not     standard practice).      In case of occurrence of a generalized tonic-clonic seizure, patients will be randomized     (1:1) to receive intravenous naloxone (0.4 mg) or placebo. Placebo will be isotonic sodium     chloride which preparation and packaging will be centralized to ensure its     indistinguishability from naloxone. Randomization will be centralized and stratified by     centre. The evolution from a partial seizure to a GTCS being gradual, and the total duration     of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course     of the seizure. Given the assumptions about the role of endogenous opioids release in the     spontaneous termination of seizures, naloxone will be administrated immediately after the end     of the GTCS and not before.      All digital data (video, EEG, respiration, SpO2) will be centralized and evaluated blind to     other data by the PI of the study who will not be involved in the video-EEG monitoring of the     included patients. The same automatic and objective analysis of SpO2 data than the one     already developed in the PHRC REPOMSE will be performed.   "
72898|NCT02331589|"     Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity,     and cancer related anti-fatigue.      Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to     receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines,     adiponectin, fatigue severity scale, and antioxidant activity were check and compared.   "
72899|NCT02331576|"     The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl     combined with local anesthetics in the post operative pain control with continuous femoral     nerve block after total knee arthroplasty.   "
72833|NCT02332434|"     Rational: The world and french epidemic of obesity and diabetes represents a major problem of     public health. The prevalence in France, in the adult population, is 15 % corresponding to     6.9 million people for obesity and 6 % corresponding to 3.9 million people for diabetes.     Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent.     Cardiovascular diseases are the first cause of morbidity and mortality. The atherogenic     dyslipidemia of these insulin-resistant obese type 2 diabetic patients characterized by the     quartet: elevated plasma triglycerides, low high-density lipoprotein-cholesterol, increased     proportion of small and dense low-density lipoproteins, is widely explained by the blood     accumulation of TRL from the liver and the intestine, and represents a major cardiovascular     risk factor. The overproduction of intestinal TRL (which apoprotein B48 is the specific     tracer) is a constituent recently recognized of insulin-resistance and the atherogenous role     of these intestinal TRL has been shown. In view of this important overmortality and the     failures of the medical, nutritional, dietary and psychotherapeutic combined treatment, the     bariatric surgery quickly developed. Two main procedures are performed: 1 based exclusively     on the gastric restriction (the sleeve gastrectomy) and one associating a malabsorption (the     gastric bypass).      Objectives: The main objective of this study is to compare the effect of each surgical     procedure and the differential effect of the 2 bariatric surgery procedures on the production     and clearance rates of the intestinal TRL. The secondary objectives are to compare the effect     of each surgical procedure and the differential effect of the 2 bariatric surgery procedures     on the production and clearance rates of the hepatic TRL and to document the potential links     between the expected reduction of these productions after the surgery and the loss of weight,     the improvement of the insulin-sensitivity, the changes in hormones, the decrease of the     inflammatory state, the changes in energy expenditure, body composition and energy intake.      Methods: It is a multicentric, prospective, comparative study of cohorts. After     identification of the eligible subjects, the kinetics (production and clearance rates) of     intestinal and hepatic TRL will be performed in the hospital, using established stable     isotope enrichment methodology (5,5,5-D3-L-Leucine), in 2 groups of obese patients (15     patients per surgery procedure), before and 6 months after the surgery.      Perspectives: A better understanding of the dyslipidemia of obese type 2 diabetic patients     and the factors modulating this dyslipidemia may lead to develop new dietary and/or drugs     and/or surgical treatments targeted at the enterocyte to improve the lipid profile of these     patients and reduce the incidence of cardiovascular diseases. Moreover, a differential effect     between the 2 surgical procedures could help to choose the best surgical procedure for obese     type 2 diabetic patients depending on the lipid profile at baseline.   "
72834|NCT02332421|"     In this study, two distractors will be used to retract maxillary canines into the extraction     sites. The first distractor is a modified Hyrax expander with two arms soldered to two bands     connected to a canine and a molar; and the second one is a similar to the first one but with     the addition of a third arm.      The purpose of this investigation is to compare the two distractors in terms of: final     position of the canine, canine pulp vitality, molars' anchorage, patient's acceptance to the     appliance.   "
72835|NCT02332408|"     Clinical objective of the study is to compare the analgesic effect, toxicity and pathologic     effect in the tumors of two radiotherapy schedules used for patients suffering from painful     vertebral haemangiomas   "
72928|NCT02331199|"     The investigators will study 200 women with singleton pregnancies presented with prelabor     preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar     body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal     pulmonary artery Doppler will be correlated with fetal outcome   "
72836|NCT02332395|"     The aim of this study is to determine the effect of surgical priority either emergency or     elective on postoperative pain in caesarean section operations. Patients whose undergo     caesarean section operation are included into this study. Patients will invite to complete     the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be     divided into two groups in terms of applied surgical priority whether emergency or elective.     After caesarean section, patient controlled analgesia is used for pain relief. And the     intensity of pain will be measured by using numerical rating scale.   "
72837|NCT02332382|"     The research subject      Health organizations around the world have determined that breastfeeding is the most critical     source of nutrition for newborns in the first weeks and months of their lives. A mother's     breast milk contains unique nutritious components and other nonnutritive elements that help     promote healthy baby growth and development (1, 2). Recent studies show that a mother's     breast milk contains components that vary from each specimen. There are great evidences that     maternal and environmental factors have a strong influence on the composition of breast milk.     Fatty acids, the second most common component found in breast milk, show extreme sensitivity     to maternal nutrition (3, 4).      Latest studies show that breast milk also contains bacterial communities that may have health     implications of newborn. The structure of these bacterial communities also varied greatly     between subjects (5) .      In the research, we propose to investigate the connection between maternal nutrition,     different fatty acids and their role in the growth and development of bacterial populations     existing in breast milk.   "
72839|NCT02332356|"     This randomized, controlled study aims to evaluate the impact of therapeutic intervention     (step up) for the patients who are clinical remission with Magnetic Resonance     Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step     down for the patients who archived clinical and MREC remission. The primary endpoint is the     rate of clinical remission at 104 weeks.   "
72840|NCT02332343|"     Dry age-related macular degeneration (AMD) is a common cause for severe visual loss in the     elderly and represents an unmet need. So far no treatment is available for geographic atrophy     (GA), which represents the advanced dry form characterized by expanding areas of outer     retinal atrophy with corresponding absolute scotoma. The foveal retina may be spared until     late in the course of the disease, a phenomenon termed foveal sparing. However, the disease     process ultimately also involves the central retina leading to irreversible loss of central     vision. While the natural history of eyes with GA has been extensively studied with regard to     the entire atrophic area, morphology-function analyses for foveal sparing GA in particular     are still missing. Such data are needed for various purposes including the future use in     interventional pharmacological trials aiming to slow the progression of GA and to preserve     the foveal retina. In this study, different imaging modalities for accurate detection and     quantification of preserved foveal retinal areas will be assessed.   "
72841|NCT02332330|"     This study is designed to collect post market data on use of the VEST, particularly on     saphenous vein grafts to the right territory of the heart.   "
72842|NCT02332317|"     The purpose of this study is to identify whether patients with newly diagnosed advanced     cancer benefit from a 12-week palliative rehabilitation program integrated with standard     oncology treatment.   "
72843|NCT02332304|"     To determine the relationship between the result of amniotic fluid optical density between 26     and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress     syndrome.   "
72844|NCT02332291|"     It can be difficult to achieve remission in individuals with late-life depression (LLD) and     they often require aggressive treatment. This challenge is in part due to age-related     vascular changes that are common in LLD. Successful antidepressant treatment involve changes     across affective, cognitive, and default mode networks. We hypothesize that in LLD, vascular     disease adversely affects response to antidepressants by disrupting connectivity of these     networks. The primary goal of this project is to characterize how focal vascular damage     affects regional connectivity and response to antidepressants. Based on past work and pilot     data, we a priori focus on the cingulum bundle and uncinate fasciculus. These key fiber     bundles connect frontal, temporal, and cingulate regions involved in cognition and affective     responses. Our central hypothesis is that ischemic damage to the cingulum bundle and uncinate     fasciculus contributes to structural and functional connectivity deficits of those tracts.     This results in a disconnection effect that alters the function of connected regions. In     turn, this increases the risk of a poor response to antidepressants.      Our approach is to enroll up to 130 adults over age 60 years with a diagnosis of Major     Depressive Disorder. Subjects will complete clinical evaluation, cognitive testing, and     MRI/functional MRI (fMRI) sessions, including an fMRI emotional oddball task that includes     attentional and affective components. Participants will be stratified by cerebral lesion     severity and randomized in a 2:1 ratio to a double-blinded 8-week trial of escitalopram or     matching placebo. Those who do not remit will transition to an 8-week trial of open-label     bupropion, an antidepressant with a different mechanism of action. This will allow us to     determine if different and distinct circuit deficits affect response to antidepressants with     different mechanisms of action while also accounting for the placebo response.   "
72845|NCT02332278|"     To determine the effect in the post operative period of early feeding (4 hours after surgery)     vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean     section.   "
72846|NCT02332265|"     The purpose of this study is to evaluate a multilevel economic and food security program     (Support to Able-Bodied Vulnerable groups to Achieve Food Security; SAFE) in rural central     Malawi as implemented and assigned by CARE-Malawi on HIV vulnerability and other health     outcomes.      Hypothesis: HIV vulnerability can be reduced through a coordinated set of locally tailored     individual and structural interventions that reduces poverty, reduces food insecurity,     strengthens community bonds, and addresses gender inequality.   "
72847|NCT02332252|"     To determine the risk of surgical site infection after surgical skin incision, comparing     electrocautery vs. scalpel.   "
72848|NCT02332239|"     The purpose of this randomized controlled study is to evaluate acceptability and feasibility,     and to gather preliminary data about efficacy, of iDOVE, a brief emergency department     introductory session + longitudinal automated text-message depression prevention program for     high-risk teens.   "
72849|NCT02332226|"     The aim of this project is to evaluate a person-centred informational intervention aimed at     parents of children with cancer.      The following hypotheses will be tested: an informational intervention emanating from the     parents' self-identified needs is associated to decreased illness-related parenting stress,     decreased post-traumatic stress symptoms, increased received knowledge, decreased anxiety,     decreased depression, increased satisfaction with information, and decreased number of health     care contacts in parents.   "
83727|NCT02190058|"     This is a randomised, double-blind, placebo-controlled multiple dose study designed to     explore the safety, tolerability and PK of DS-1971a following oral administration over 14     days to healthy male subjects.   "
72851|NCT02332200|"     This is a retrospective chart review with a short follow-up phone questionnaire for our     patients who have been treated by Nationwide Children's Hospital physical therapy and sports     medicine for a spondylolysis or spondylolisthesis injury.      Currently, no research exists to guide referral for safe physical therapy rehabilitation for     patients with spondylolysis and spondylolisthesis injuries. By performing this retrospective     study the investigators can gain information to better guide physical therapy referral time.     This may also serve as foundation for a future prospective randomized trial.      Currently, Nationwide Children Hospital physicians vary from immediate referral to physical     therapy to 3 + months of rest prior to beginning therapy. By performing a retrospective chart     review assessing time to referral to therapy and patient outcomes the investigator can gain     some guidance for when it is safe to prescribe physical therapy rehabilitation for patients     with spondylolysis and spondylolisthesis injuries.      Patients with an active spondylolysis or spondylolisthesis injury who are referred to     physical therapy early will return to activity/sport sooner without increased risk of adverse     reaction.   "
72852|NCT02332187|"     Patients that are on mechanical ventilators in medical intensive care units (MICU) have     extremely weak leg muscles. Currently there is no treatment to prevent or reverse this     weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg     muscle strength and help patients regain leg function after knee surgery. The purpose of the     present study is to determine if treatments with the All Stim 2 device can also improve leg     muscle strength in patients on mechanical ventilation.   "
72853|NCT02332174|"     The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of     single and multiple doses of rufinamide. The effects of food and sex on the PK properties of     rufinamide in these Chinese volunteers were also evaluated.   "
72854|NCT02332161|"     Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and     neck reconstruction after head and neck cancer removal. The procedure involves removing some     muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of     this study is to determine the impact of ALT on ambulation and activities of daily living     (ADLs)   "
72855|NCT02332148|"     3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of     the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study     to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will     self-treat for 30 days.   "
72856|NCT02332135|"     Microwave ablation, as a new method to therapy secondary hyperparathyroidism(SHPT), now is     developing rapidly. However, it is still unknown whether it is effective to accept microwave     ablation for hemodialysis patients with mild-to-moderate SHPT. In this prospective,     randomised control and paried clinical trial study, the investigators will observe the     efficiency and safety of microwave ablation in hemodialysis patients with mild-to-moderate     secondary hyperparathyroidism. The patients in age-matched control group will accept active     Vitamin D therapy.   "
74532|NCT02310191|"     New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery     stenting (CAS). The aim was to assess correlation between selected laboratory markers and     occurrence of new brain infarctions after CAS.   "
72857|NCT02332122|"     A single center case-control study with 100 COPD patients will be organized to compare     patients with and without bronchiectasis with regard to the presence of Aspergillus in sputum     samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be optimized     for culture, Aspergillus galatomannan analysis and RT-PCR.      This study is part of a larger project in which we assume that chronic respiratory infection     by Aspergillus fumigatus and the accompanying immune response play an important role in the     development of bronchiectasis in COPD. We suspect that this mechanism is controlled by     vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus.      The present study is designed by the Laboratory of pneumology and will be conducted in     collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic     University of Leuven.   "
72858|NCT02332109|"     Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of     corneal edema caused by Fuchs' endothelial dystrophy.   "
72859|NCT02332096|"     Diagnosis and treatment of sleep apnea with continuous positive airway pressure (CPAP)     therapy has been shown to decrease arrhythmia recurrence in patients with AF following     ablation. However, patients with AF undergoing ablation are not routinely screened for sleep     apnea, despite an estimated sleep apnea prevalence of 25% in the general population, and     perhaps higher among patients with AF. Home sleep testing is frequently used for evaluation     of sleep apnea.   "
72860|NCT02332083|"     The goal of this randomized controlled study was to examine the effects of a 8 weeks     innovative training regime (stochastic resonance whole-body vibration [SR-WBV] and virtual     virtual games [VG]) in the skilling up phase on physical performance, cognition and falls in     elderly in need of care population.   "
72861|NCT02332070|"     1. To examine two main predictor variables independently and then jointly in stratified and          multivariate analyses for the outcomes of CSA-AKI, MARCE, need for RRT, and inpatient          mortality, and the composite, as well as the outcomes of 30 day rehospitalization or          death, and finally for the days out of hospital and alive adjusted to person-year of          time             1. Days from coronary angiogram performed with IOCM to cardiac surgery (1, 2, 3, etc)             2. Thakar Acute Renal Failure (ARF) score (1 to 17)        2. To examine the interrelationships between time in days between angiogram and surgery and          the ARF Score with the Society of Thoracic Surgery (STS) Risk score for mortality   "
72862|NCT02332057|"     The aim of this study is to determine the effectiveness of a combination of diclofenac and     lidocaine gel in reducing pain during IUD insertion.   "
72863|NCT02332044|"     The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and     Bepotastine besilate in healthy adult volunteers.   "
72864|NCT02332031|"     To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and     elimination of sorafenib and safety in healthy male subjects   "
72865|NCT02332018|"     Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs     in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose     protocol   "
72866|NCT02332005|"     An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in     diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an     oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the     effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12     months of treatment. Subjects will be assessed at screening and baseline, with office visits     every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion,     the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve     conduction velocity that is expected to be demonstrated in the group randomized to placebo     treatment for up to 12 months.   "
72867|NCT02331992|"     Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting     around 2-4% of the middle aged population and is characterized by periodic collapse of the     upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary     treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway     obstruction, acceptance of and adherence with therapy has been sub-optimal.      Over the past decade, considerable research has focused on determining the factors     responsible for poor CPAP adherence. Two key areas have been identified: patient-reported     symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the     importance of patient education and support. In addition we know that the patient experience     during the crucial first days and weeks of their journey predicts longer term adherence.      This study investigates the ability of an automated program that assists patients towards     continuous positive airway pressure (CPAP) therapy adherence.   "
72868|NCT02331979|"     This trial will investigate the safety and utility of spinal cord neuromodulation to improve     urinary bladder function in the context of spinal cord injury.   "
72869|NCT02331966|"     The tumors that cause oncogenic osteomalacia (TIO) express and release in the circulation     phosphaturic factors such as fibroblast growth factor-23 (FGF-23) that decrease renal     phosphate absorption through acting in the proximal renal tubule and decreasing Type 2a and     2c sodium-phosphate co-transporter. They typically follow a benign clinical course and even     in the rare malignant cases, local recurrence occurs in less than 5% and distant metastasis     are very uncommon.      In this study we aim to investigate the role of other molecular pathways such as ERK1, ERK2,     mTOR, EGFR, MEK1, MEK2, VEGFR3, AKT1, AKT2, IGFR-1, IGFR-2, PDGFRA, PDGFRB, cMET, FGFR2,     apart from FGF23, KLOTHO and PHEX, in the behavior of histopathologically benign mesenchymal     phosphaturic tumors.   "
72870|NCT02331953|"     Postoperative delirium is an important problem in patients undergoing major surgery. The     incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery. A     study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is associated     with postoperative delirium after on-pump cardiac surgery. This same perturbation likely also     increases the risk for postoperative delirium after spine surgery, although there are little     data that have evaluated this hypothesis. Therefore, this observational study was designed to     explore the relationship between perioperative rSO2 and the delirium in elderly patients     undergoing spine surgery.   "
72871|NCT02331940|"     The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the     HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality     in patients with COPD.   "
72872|NCT02331927|"     The primary objective of the two phase PERMAD trial is the evaluation of the impact of a     personalized marker-driven treatment approach with early detection of progression and     modification of treatment on cytokines and angiogenic factors (CAF) and efficacy.      In regard of the two parts, the primary objective of the run-in phase (n=50 patients) with     conventional switch of chemotherapy together with the anti-angiogenic agent is the     determination of a distinct cytokines and angiogenic factor (CAF) profile during treatment     with FOLFOX and bevacizumab, which allows early detection/prediction of progressive disease.     The primary objective of the marker-driven randomized part (n=150 patients) with     marker-driven switch of antiangiogenic agent and maintenance of chemotherapy is the     evaluation of the efficacy of an early marker-driven switch of anti-angiogenic treatment     (bevacizumab to aflibercept)      This is a multicentre, multinational, open labeled, prospective, randomized, controlled phase     II study designed to assess the clinical utility of an early marker driven change of     anti-angiogenic treatment (bevacizumab to aflibercept) maintaining the chemotherapy backbone     until definite radiological progression in first line treatment of patients with metastatic     colorectal cancer. After completing the run in phase of the study, with at least 30 patients     completing their first line treatment (due to progression, secondary resection or toxicity)     and being evaluable for CAF analyses, the results will be reviewed by an Independent Data     Monitoring Committee (IDMC). Based on that review the decision to continue with, modify or     cancel the randomized part will be made.      The primary endpoint of the run-in phase with conventional switch of chemotherapy together     with the anti-angiogenic agent is:      • Progression free survival (PFS1) of first line treatment      The primary endpoint of the randomized part with marker-driven switch of antiangiogenic agent     and maintenance of chemotherapy is:      • Progression free survival rate at 6 months (PFSR@6) after first cycle after randomization.   "
72873|NCT02331914|"     Gastrointestinal stromal tumors (GISTs) belong to the sarcoma group and are characterized by     oncogenic mutations in the c-KIT, PDGFRA, BRAF and NF-1 genes that drive tumor growth. Since     tyrosine kinase inhibitors (TKIs) have become available, the median survival of GIST patients     increased from 9 months to over 5 years. Consequently, this rare disease has become a role     model for other targeted therapies. However, response to TKIs is extremely heterogeneous:     ~15% of the patients experience no benefit from imatinib, whereas ~17% of the patients enjoy     stable disease for over 9 years. Treatment failure due to primary and secondary resistance is     caused in part by mutations in oncogenic genes that cause change in drug sensitivity. A new     technique, using circulating tumor DNA, has enabled us to assess mutations in a simple blood     sample obtained from patients on treatment, and thus detect new mutations early in the course     of the disease. Also, differences in pharmacokinetic drug behavior add to the observed     heterogeneity, and may cause resistance due to drug underexposure and thereby proliferation     of the least sensitive tumor cells. This offers the opportunity to optimize and personalize     targeted treatment for individual GIST patients by timely treatment adaptation based on early     detection of secondary TKIs resistance mutations. Achieving this urgently requires data on     daily clinical practice, including prospective serial mutation analysis and serial drug     plasma concentration measurement. At a fundamental level this will also help to unravel the     driving factors behind primary and secondary TKIs resistance in this model disease.   "
72874|NCT02331901|"     This study examine the possible microstructural changes in the middle brain after mTBI using     diffusion MRI   "
72875|NCT02331888|"     Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When     necessary according to clinical indications, the scalp electrode will be connected. Tracing     will be recorded simultaneously from all three devices until delivery.   "
72929|NCT02331186|"     Urinary incontinence is well documented as a comorbidity of obesity. Studies demonstrate     improvement of incontinency after weight loss. However, the mechanisms are still not clear.     Aim of our study to analyze the effects of bariatric surgery on pelvic floor function in     women.   "
72876|NCT02331875|"     The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and     pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative     patients with operable Squamous Cell Carcinoma of the Oral Cavity .      43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose     of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.     Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated     after the last administration of IPH2201.   "
72877|NCT02331862|"     Purposes of this study will be as follows:        1. To design a prospective, randomized, and open-labeled study to investigate the effect          and the side effect of MPD in combination with conventional antibiotics to affect          clinical course, outcome, and medical expenses.        2. To compare level of the urinary and serum cytokines before and after received MPD for          the following sub-aim:      I. To determine the population who is benefit from MPD to reduce the severity of clinical     course and subsequent renal scarring.      II. To understand the mechanism by which the MPD could shorten the clinical course and reduce     the renal scarring.   "
72878|NCT02331849|"     Esophageal Motility in eosinophilic esophagitis will be evaluated by High Resolution     Manometry before and after medical treatment - motility is suspected to change/improve after     therapy.   "
72879|NCT02331836|"     Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the     adenoma detection rate (ADR)   "
72880|NCT02331823|"     Multi-center, prospective study is performed to investigate the efficacy of new short-course     regimen for retreatment pulmonary tuberculosis patients.      To obtain optimized short-course regimen, decrease treatment cost and improve success rate.   "
72881|NCT02331810|"     Primary Objective:      Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell     subsets compared to placebo.      Secondary Objectives:      Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability     and safety of SAR113244.      Assess in male and female lupus patients:        -  The pharmacokinetics of SAR113244.        -  The pharmacodynamics of SAR113244 for the following disease parameters:             -  Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus               Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus               Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus               Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index               (if applicable), Lupus-quality of life and Functional Assessment of Chronic Illness               Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and               anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte               sedimentation rate and C-reactive protein.             -  Peripheral blood B and T cell subsets.   "
72882|NCT02331797|"     Minimally invasive surgery is becoming more common in many surgical fields. The wide view of     endoscope allows for minimally invasive transcanal approach instead of large postauricular     opening. The investigators conduct this study to compared post operative pain score (by     Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and     endoscopic lateral placing tympanoplasty.   "
72883|NCT02331784|"     The primary objective of this study is to evaluate the effects of the experimental treatment     (cognitive training) further outlined in this protocol on the cognitive abilities (e.g.,     processing speed, attention, working memory, and executive function), brain functionality,     functional status and quality of life of individuals with age-related cognitive decline as     compared to a computer-based active control.   "
72887|NCT02331732|"     This trial aims to increase the wellbeing of tuberculosis patients and their adherence to     medication in Chisinau, The Republic of Moldova. The design is an individually randomised     controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of     treatment. The trial will have two arms; 200 patients will form the control group and receive     the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually     Observed Treatment (VOT).      VOT differs from DOT in that the daily observation of patients taking their medication will     be observed via internet video messages rather than in-person. Based on a small sample of     patient interviews we think that for some patients DOT may be a hindrance rather than a help.     VOT allows patients to take their treatment in the comfort of their home and means they don't     have to travel to their polyclinic every day.      There will be a central VOT observation centre where VOT observers will view and respond to     video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health     app. The VOT observers will also respond to the patients by sending feedback to the patients.     The trial duration will depend on the recruitment rate of eligible patients but is expected     to take 16 months.   "
72888|NCT02331719|"     Intracerebral hemorrhage (ICH) is the most severe form of stroke: early mortality is 40%, and     80%-of survivors are physically disabled with high rates of cognitive impairment and     depression.      In an effort to address the issues with conventional treatments, a new integrated systematic     approach has been developed. This approach utilizes an educational process where specific     core competencies (pillars) of mapping, navigation, access, optics and automated resection     have been integrated into a single standardized system to deliver targeted therapy for an     individual patient based on location and patient factors. This system has demonstrated safety     and efficacy in oncology patients and is also FDA approved for use in the ICH patient     population as well.      This registry will collect data form multiple site that preform the MiSPACE procedure as part     of clinical care. The intent of this registry is to collect data on the economic impact as     well as clinical outcomes using the MiSPACE approach with the integrated technology in the     early treatment of ICH.   "
72889|NCT02331706|"     This trial is designed to determine the feasibility of conventional induction chemotherapy,     IFNand G-CSF mobilized DLI (IFN-DLI) in subjects with relapsed AML and ALL after allo-SCT.   "
72890|NCT02331693|"     The purpose of this study is to determine whether autologous T cells bearing chimeric antigen     receptor that can specifically recognize EGFR overexpressed in tumor cells is safe and     effective for patients with EGFR-overexpressing malignant glioma.   "
72891|NCT02331680|"     This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral     administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal     failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume     of at least 500 mL/day.   "
72893|NCT02331654|"     Pain represents one of the most common symptoms of Multiple Sclerosis (MS) that can seriously     affect patient health-related quality of life.      Central neuropathic pain, the main form of pain in MS patients, represents a significant     clinical problem, in consideration of its poorly responsiveness to available therapies.      Direct Current Stimulation (tDCS) is a non-invasive, well-tolerated procedure with an high     and well documented neuromodulation activity at Central Nervous System (CNS) level. First     evidences obtained by animal, neurophysiological and clinical studies suggested its potential     efficacy in neuropathic pain treatment.      In particular spinal DCS (sDCS) has been proven to modulate Nociceptive Withdrawal Reflex     (NWR), an objective and sensitive tool to explore pain processing at the Spinal Level and     recommended by European Federation of Neurological Society (EFNS) to evaluate the analgesic     effect of treatments. In this order of view the investigators' objective is to investigate     sDCS efficacy in MS neurophatic pain treatment applying validated clinical scales,     neurophysiological acquisitions and specific biological marker dosages.   "
72894|NCT02331641|"     The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in     patients with colorectal liver metastases (CLM) is object of debate. We build a study, using     the propensity score matched analysis, to compare the short- and long-term outcome of the tow     groups of patients.   "
72895|NCT02331628|"     Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in     Traumatic Brain Injured (TBI) patients      Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known     late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is     used in various medical situations and is being tested for feasibility of use in TBI     patients.   "
72896|NCT02331615|"     Traumatic brain injury (TBI) particularly affects the frontal lobes and patients often suffer     from executive dysfunction and behavioral disturbances. These types of injuries often involve     axonal damage to pre frontal brain areas, which mediate various cognitive and behavioral     functions. Dorsolateral prefrontal circuit lesions cause executive dysfunction, orbitofrontal     circuit lesions lead to personality changes characterized by disinhibition and anterior     cingulate circuit lesions present with apathy. Patients who suffered traumatic frontal lobe     damage often demonstrate a lasting, profound disturbance of emotional regulation and social     cognition.      Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes     in the human motor cortex. this effect depends on the stimulation polarity and is specific to     the site of stimulation. Interacting with cortical activity, by means of cortical     stimulation, can positively affect the short-term cognitive performance and improve the     rehabilitation potential of neurologic patients. In this respect, preliminary evidence     suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect,     and other cognitive disorders.      Several possible mechanisms can account for the effects of tDCS and other methods on     cognitive performance. They all reflect the potential of these methods to improve the     subject's ability to relearn or to acquire new strategies for carrying out behavioral tasks.     It was also found that Activation of prefrontal cortex by tDCS reduces appetite for risk     during ambiguous decision making.      In this tDCS study the investigator uses one anode and one cathode electrode placed over the     scalp to modulate a particular area of the central nervous system (CNS). The stimulation is     administered via the neuroConn DC.Stimulator Serial number 0096. The DC-STIMULATOR is a     micro-processor-controlled constant current source. The DC-STIMULATOR is a CE-certified     medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on     people.Electrode positioning is determined according to the International EEG 10-20 System.   "
72897|NCT02331602|"     The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared     with dabigatran in patients with atrial fibrillation.   "
72900|NCT02331563|"     A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III     were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D (n     = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general     anaesthesia. Total local anaesthetic volume was standardised with 20 ml each sides of the     abdomen. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption     were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4,     5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of     postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.   "
72901|NCT02331550|"     To evaluate the rate of regression and progression of low-grade squamous intraepithelial     lesion comparing expectant vs. ablative treatment.   "
72902|NCT02331537|"     The purpose of this study is to examine if an internet-based exposure therapy is effective in     reducing excessive worry amongst patients who suffer from this problem.   "
72903|NCT02331524|"     There are few studies that demonstrate how to best improve daily activity in people with     heart failure (HF). Exercise alone has been shown to be ineffective, but other techniques     such as daily activity feedback with encouragement or health coaching may be helpful. This     research study will investigate two different treatment approaches for improving daily     activity: 1) daily activity feedback and encouragement, and 2) health coaching with an     individualized home exercise program. Both treatment approaches are hypothesized to result in     improved daily activity compared to a control group.   "
72904|NCT02331511|"     The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the     prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.   "
72905|NCT02331498|"     A phase I/II study of pazopanib in combination with temozolomide in patients with newly     diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)   "
72906|NCT02331485|"     Aim of the study is to assess the role of negative pressure therapy in the prevention of the     complication of the laparotomy wound in the high risk patients group.      Primary outcome: Reduction in wound infection rate by 50%      Secondary outcome: Reduction of the length of hospital stay Decrease of using abx. for wound     management Decrease cost of patient treatment   "
72907|NCT02331472|"     This study is to evaluate the efficacy of urine biomarker in patients with interstitial     cystitis/painful bladder syndrome   "
72908|NCT02331459|"     Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it     is not known physical training pattern more beneficial for these patients. The reasons for     heterogeneity and lack of consistency of the results described by published intervention     programs may be the diversity of isolated - resistance, endurance or proprioceptive trainings     - or a combination of them. There are no studies with a combined program of this three kinds     of physical training.      The objective of this study is to know if a multicomponent physical training program during     180 days in dwelling-community frail geriatric patients can improve scores on functional,     activities of daily living, mood, cognitive and quality of life scales and producing changes     in blood levels of biological and genetic markers.   "
72909|NCT02331446|"     The investigators will do an intervention on four groups of previously sedentary     post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol;     group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical     protocol; group 4 - sedentary control women. The protocol consists of three sessions per week     of concurrent training (half session with aerobic training and the other part with weight     training). Inflammatory and oxidative parameters will be analyzed and the investigators     hypothesized that 90 minutes per week of concurrent training (group 1) will reduce the     inflammatory parameters and the oxidative stress, and this improvements will be greater so     much as the longer the sessions (a dose-response effect). The physical activity practiced out     of the intervention will be controlled by a questionnaire (the commuting and leisure sections     of the International Physical Activity Questionnaire) and the food intake by a 24-hour food     recall.   "
72910|NCT02331433|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     APN1125 when administered as single doses to healthy adult subjects.   "
72911|NCT02331420|"     To assess the impact of weight loss due to bariatric surgery, as compared to the effect of     optimal medical therapy alone on endothelial function, subclinical atherosclerosis,     cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study     consists in a 2-arm randomized trial, in which patients will be randomly assigned to     bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0)     and 12 months thereafter (T1).   "
72912|NCT02331407|"     Stroke is a leading cause of neurological disability worldwide, often causing significant     weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is     project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke     therapy devices have the potential to be a cost-effective device aid to physical therapy and     enable novel modes of exercise not currently available. While recent studies have shown     chronic patients benefit from repetitive practice, it is not clear whether they improved via     a reduction in impairment or increased functional compensation because there is a lack of     standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients.     This study aims to reconcile difference performance measurements in robotic rehabilitation to     assess the outcome of robotic rehabilitation training.   "
72913|NCT02331394|"     The current proposal is a feasibility and acceptability study to establish the necessary     groundwork for more detailed investigations into the role of CH in reducing symptoms and     improving quality of life in NSCLC patients at the Jewish General Hospital (JGH). A     standardized and easily administered form of CH will be used, incorporating a carefully     selected combination of herbs designed to alleviate a range of common symptoms suffered by     patients with advanced NSCLC.   "
72914|NCT02331381|"     The results of this imaging and treatment planning protocol will aid in developing procedures     for patient localization and future clinical implementation of low-field MRI to confirm     positioning prior to radiation treatment. Images acquired during this study may aid future     study design for adaptive planning based on low-field MRI images. Moreover, results of this     imaging and treatment planning may lead to guidance on optimal use of this novel device.   "
72915|NCT02331368|"     Multiple myeloma (MM) is a common incurable blood cancer causing debilitating symptoms-bone     pain, kidney failure, low blood counts and infection. Chemotherapy outcomes are disappointing     due to short-term response and long-term toxicities.        1. Studies showed these patients have weak immune against MM due to the immune checkpoint          mediated by the PD1/PD-L1 interaction between immune cells and MM. Anti-PD-1 antibody          (anti-PD1) disrupts this interaction, thus unleashing immune cell function and leading          to killing of MM cells.        2. Studies further showed enhancement of this unleash after autologous transplant and          better MM control by anti-PD1 when used after transplant.        3. Anti-PD1 has been extensively studied in patients with other cancers. It is very safe          and effective and has been FDA-approved. Complications are of mild degree and easy to          manage successfully in out-patient setting. Severe complications are rare.      Thus, we are proposing an efficacy study of anti-PD1 treatment after transplant to improve MM     treatment outcomes. This is a collaborative study with Medical College of Wisconsin     (headquarter of Center for International blood and Marrow Transplant Research). We     hypothesized that anti-PD1 treatment will increase the MM response and the MM control     duration when it is added to the standard MM treatment after transplant. Anti-PD1 will be     given at the dose and interval, which had been studied previously (200 mg intravenous     injection every 3 weeks) between 2 weeks until 6 months after transplant. Subjects will be     monitored closely during and after anti-PD1 therapy until at least 1 year post transplant.     Late complications will be followed until 3 years.   "
72916|NCT02331355|"     There is an urgent need to develop hand transplant programs in this country. To this end, the     University of Michigan Hospital and Health Systems is developing such an interdisciplinary     program. The Transplant Center would like to track the patient experience from pre-operative     care through surgery and post-operative care.      Detailed information will be collected from the patient medical records, including:     Pre-operative screening, demographics, medications; Surgical information ; Post-operative     inpatient and out-patient care; laboratory and other test results; physical assessments,     psychological assessments and quality of life assessments.   "
72917|NCT02331342|"     Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac     diseases. The aim of the study at hand was to evaluate NICOM (bioreactance) as a new method     for determinion of CO and to compare it to Innocor (inert gas rebreathing), which previously     showed promising results.   "
72918|NCT02331329|"     Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac     diseases. The current standard methods for the determination of CO, however, are either     invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic     resonance tomography, MRT). Therefore, the aim of the study at hand was to evaluate NICOM     (bioreactance) as a new method for determinion of CO and to compare this new technique to     MRT.   "
72919|NCT02331316|"     The purpose of this study is to find out if drinking extra water helps people lose or     maintain weight loss and reduce hunger and, if so, what volume of water is most effective and     when is it best to drink it.   "
72920|NCT02331303|"     The objective of this study is to evaluate the extent of potential off-label use of Xofigo in     Sweden.   "
72921|NCT02331290|"     This study is designed to determine if changes in acetyl amantadine (AA) metabolism with     systemic chemotherapy - reflective of SSAT1 activity - are predictive of response to systemic     therapy in patients with lung cancer. Ten patients with adenocarcinoma and 10 with small-cell     cancer who are at American Joint Committee on Cancer (AJCC) stages 3 or 4 at the time of     diagnosis will participate. AA metabolites will be examined by ELISA prior to initiation of     systemic chemotherapy and after the second cycle of therapy. Changes in the pattern of     metabolites will be correlated with convention clinical and radiographic response criteria.   "
72922|NCT02331277|"     The primary objective of this trial is to investigate the safety and tolerability of multiple     doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese     male volunteers.      The secondary objective is the exploratory evaluation of the pharmacokinetics and     pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4     weeks in healthy Chinese male volunteers.   "
72923|NCT02331264|"     PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on     cardiac function      STUDY OUTCOME MEASURES      To assess the effect of metal ions from hip implants on cardiac function as measured by     Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate     detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction     and tissue characterization (with and without contrast).      STUDY IMPACT      With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK),     and over a million worldwide, there is need to clarify this important question, which is the     source of significant concern amongst patients and surgeons alike. Also, this problem is not     unique to MOM hips since all hip implants contain metal and as seen in various case reports     high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic     bearing surface) leading to abnormal wear of the implant and release of metal ions into the     body. In the UK, over 80,000 hip implants are inserted annually.   "
72924|NCT02331251|"     The Phase Ib and II cohorts will enroll patients with metistatic solid tumors.      Phase II only will enroll the following patients:      Patients with metastatic sarcoma to be enrolled in the following 4 arms: pembro plus     gemcitabine, pembro plus gemcitabine and docetaxel, pembro plus gemcitabine and vinorelbine,     and pembro plus liposomal doxorubicin.      Patients with metastatic pancreatic adenocarcinoma to be enrolled in the pembro plus     gemcitabine and nab-paclitaxel arm.      Patients with extensive-stage small cell lung cancer to be enrolled in the pembro plus     irinotecan arm.      Patients with ER+ breast cancer to be enrolled in the pembro and vinorelbine arm.      Patients with ovarian cancer to be enrolled in the pembroplus liposomal doxorubicin arm.      Patients with metastatic TNBC (ER/PR/HER2 negative) to be enrolled in the pembro plus     gemcitabine arm.   "
72972|NCT02330627|"     The proposed project aims to test the efficacy and neural correlates of a behavioral     treatment program comprised of positive activity interventions in a sample of individuals     seeking treatment for anxiety or depression. Participants will be randomly assigned to an     immediate or delayed treatment condition, and will be compared on measures of positive and     negative emotions, brain responses to reward and punishment/loss, subjective well-being, and     symptoms at baseline and post-treatment.   "
72925|NCT02331238|"     This cluster-randomized school-based study will examine the effectiveness of a program for     the primary prevention of perpetration of teen dating violence and sexual violence among     middle school male athletes. Engaging men and boys in preventing violence against women and     girls is recognized by major global health organizations as a critical public health     strategy. Coaching Boys into Men is a theory- and evidence based program intended to alter     gender norms that foster teen dating violence/sexual violence perpetration, promote bystander     intervention, and reduce teen dating violence/sexual violence perpetration. Coaches receive a     60-minute training and biweekly check-in from a violence prevention advocate to administer     the intervention to their athletes via 12 mini-lessons conducted weekly throughout a sport     season. In a randomized trial of program effectiveness among high school athletes (Centers     for Disease Control and Prevention CE001561-01, PI Miller), male athletes receiving the     program demonstrated increased positive bystander intervention behaviors and less verbal     abuse perpetration compared to controls. This project seeks to test the effectiveness of this     program with younger male athletes in grades 6-8.The innovations are three-fold: (1) testing     the efficacy of a novel teen dating violence/sexual violence prevention program for middle     school male athletes; (2) training athletic coaches in Teen Dating Violence/Sexual Violence     prevention thus implementing primary prevention that does not rely on teachers or classroom     time; and (3) integrating the goal of changing gender norms with the technique of a bystander     intervention approach to reduce teen dating violence/sexual violence prevention. The     experimental design involves a 2-armed cluster randomized- controlled trial in 41 middle     schools (38 clusters) in Pennsylvania. Schools will be randomly assigned to either     intervention or control (standard coaching) condition. Coaches in intervention schools will     receive Coaching Boys into Men training. Baseline surveys will be collected for all     intervention and control site athletes entering grades 6-8 at the start of each sports     seasons across Year 1 (Time 1; N= 973 athletes). Follow up surveys will be collected at the     end of each sports season (Time 2). All participating athletes will be re-surveyed 12 months     after baseline (Time 3).   "
72926|NCT02331225|"     Systemic sclerosis (SSc, also known as scleroderma) is a disease characterized by fibrosis of     the skin and organs, inflammation, and an abnormal endothelial cell lining inside of vessels.     A common and deadly complication of SSc is pulmonary hypertension (PH), which is an abnormal     elevation in the blood pressure within the lung blood vessels. Early identification and     treatment of PH is important in SSc, and no clinical factors can predict which patients will     develop PH with acceptable accuracy. A potential marker of PH in SSc is the presence of     increased amounts of endothelial microparticles (EMPs), which are substances circulating in     the blood that were released from damaged vessel wall endothelial lining. A main goal of this     study is to investigate if there is a difference in EMP levels between SSc patients with and     without PH. The investigators will also use human endothelial cells in a lab environment to     test whether these EMPs isolated from SSc patients are actually causing damage to the vessel     lining. Lastly, the investigators will investigate the potential benefit of a medication used     after transplant, mycophenolate mofetil (MMF). This will be done by causing damage to     isolated human endothelial cells and treating them with MMF. The main goal of this portion of     our study is to see if EMP levels are reduced when cells are treated with MMF. Overall, the     investigators anticipate the following outcomes of this study: 1) use EMP levels to     differentiation patients with SSc who have PH from those without PH, 2) use EMPs to     understand how endothelial damage occurs in SSc, and 3) use EMPs to help us develop new     treatments for patients with vascular diseases.   "
72927|NCT02331212|"     This research trial studies the role of a substance called hyaluronic acid in causing the     growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells     are a type of cancer cells that may cause the cancer to spread to other parts of the body.     Studying samples of blood and bone marrow from patients and animal models in the laboratory     may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the     bones.   "
72931|NCT02331160|"     Breech presentation occurs in approximately 3-5% of all pregnancies, and breech birth is more     complicated and risky for the fetus than births of fetuses in the cephalic position.      Therefore, it is desirable to turn the fetus from breech presentation to cephalic position     before labour. This is traditionally done by external cephalic version, where the doctor     manually tries to turn the fetus; the success rate of this is approximately 50%, and     complications occur in about 0.5%. In addition there is discomfort and pain to the pregnant     woman.      The investigators will assess the effect of using the rebozo prior to the external version.     Use of rebozo is a recognized technique from Mexico, where the midwife with a scarf 'shake'     the pregnant woman's pelvis over several sessions, so the fetus spontaneously turns to     cephalic presentation or the external version is facilitated.      There are no known complications associated with the rebozo method. Use of rebozo in breech     presentation has never before been studied scientifically, but is used in many places in the     world. The investigators are planning an open-labeled randomized controlled study in     pregnancies with verified breech or transverse presentation: by lot either standard external     cephalic version or preceding rebozo-treatment with subsequent external cephalic version.      The investigators want to assess whether the use of rebozo - either as pre-treatment for     external cephalic version or as a catalyst of spontaneous version - will increase the     incidence of the cephalic presentations at labour and thus reduce the number of planned     caesarean section.      The population will be pregnant women with ultrasound verified breech or transverse     presentation;all women who fulfill the local guideline criteria for external cephalic     version, can be included. Exclusion criteria are non-Danish speaking or reading.      The recruitment will be conducted by midwife at week 35 in the antenatal care. The study     design will be open-labeled randomized controlled. Randomisation is done by closed envelope     method and stratified by parity. Intervention is rebozo exercises performed over 3-5 days     from randomization. In case of persistent breech presentation, the woman is offered standard     external cephalic version. The control group will also be offered external cephalic version     after 3-5 days from randomization.      The investigators will use source data from existing local databases, Obstetrics Database     and version Database, for collecting birth outcome. In all stages of intervention     documented electronically by project midwives.      The primary objective is the number of successful versions in total, i.e., after intervention     and external cephalic version. We expect to increase the success rate from 50% to 65%, thus     requiring 378 women in the study.      Secondary objectives are the number of successful vaginal births with birth in head position     and total number of caesarean.   "
72932|NCT02331147|"     This is comparison trial comparing human dermis to standard wound care for non healing     diabetic wound   "
72933|NCT02331134|"     The overall goal of this study is to develop a pre-clinical platform of melanoma and head and     neck squamous cell cancer that will allow the investigators to learn more about these     diseases and discover better and more individualized treatments.   "
72934|NCT02331121|"     Unintentional injuries are the leading cause of death for children and infants under 14 years     of age. Many of these deaths are preventable, in part by promoting injury prevention     behaviors but also by administering effective emergency first aid techniques until advanced     care arrives. This project created a web site program that paired video-based instruction     with interactive skills training to teach parents of children birth to 12 years old basic     first-aid and CPR skills, and that included the option to practice skills as needed.   "
72935|NCT02331108|"     To compart differences on the effect on core temperature between anesthetic induction with     intravenous propofol versus inhalation induction with sevoflurane   "
72936|NCT02331095|"     This is a pilot, randomized, open-labelled study. Eligible patients will be enrolled and     randomized 1:1 into anticoagulation arm or anticoagulation plus atorvastatin arm, with     atorvastatin given at 40 mg orally daily for 3 months. The targeted total accrual is 80     patients, with 40 in each arm. Patients will be recruited from the hospitals and clinics at     The Ohio State University Wexner Medical Center. Follow up visits are planned at enrollment,     3 months, and 9 months after randomization. At each follow up, blood will be obtained and     assessments will include structured interviews of signs and symptoms of recurrent venous     thromboembolism (VTE), bleeding, post thrombotic syndrome, and adverse events from study     drugs.   "
72937|NCT02331082|"     Globally, over seven million children under the age of five die each year, although a suite     of interventions—safe delivery care, neonatal care and resuscitation, and management of     childhood diarrhea, malnutrition, and pneumonia—can prevent many of these deaths when     implemented within functioning health systems. This study will include a quasi experimental,     stepped wedge, cluster-controlled trial of a mobile health care coordination and quality     improvement intervention designed to facilitate comprehensive health systems strengthening.     It will do this through training and equipping community-level health care clinics to manage     chronic diseases through use of the Chronic Care Model, structured quality improvement     sessions to promote clinical mentorship, and use of an integrated electronic medical record     to provide real-time data for disease surveillance. The investigators hypothesize that     improving upon the health system in these ways will lead to a 25% reduction in under-two     mortality through improved services for the citizens of Achham, Nepal.   "
72938|NCT02331069|"     The posterior antebrachial cutaneous nerve (PACN) can be compressed between the deltoid and     triceps, with resultant pain and dysfunction. The active treatment for this study will be     injection of the point of compression and along the painful course of the sensory nerve with     5% dextrose. The control treatment will be physical therapy.   "
72939|NCT02331056|"     There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one     lung ventilation. The overloading of fluid administration could be related to the development     of pulmonary edema in patents after thoracic surgery. But fluid restriction may cause major     organ hypoperfusion during the surgery. The purpose of this study is to evaluate the ability     of stroke volume variation as an indicator for a fluid responsiveness in patient who receives     pulmonary lobectomy via thoracotomy.   "
72940|NCT02331043|"     Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.     LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols     as esters per day) is less well known.   "
72941|NCT02331030|"     This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular     brachial plexus block in patients undergoing arteriovenous graft creation surgery.     Participants will be randomised into two equal groups, one receiving supraclavicular and pecs     II blocks, the other receiving supraclavicular block and sham block (Grade 1).   "
72942|NCT02331017|"     To evaluate the combination of electric hearing through Cochlear Implant and acoustic hearing     through hearing aid in bimodal users with moderate-to-severe hearing loss in the     non-implanted ear. The research will also provide pilot study data on unilateral Cochlear     Implant recipients with residual useful acoustic hearing in the implanted ear whose acoustic     hearing has been preserved.   "
72943|NCT02331004|"     Investigators have created a protocol of intervention to treating the general disability of     upper limbs.   "
72944|NCT02330991|"     The purpose of this study is to evaluate the clinical benefit and safety of two different     Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous     dose-intense regimen）in patients with glioblastoma at first relapse.   "
84348|NCT02181972|"     The primary objective of this study was to assess the efficacy and safety of Gingko biloba     film-coated tablets in improving cognitive function and neuropsychological functioning of     middle-aged cognitively intact adults.   "
72945|NCT02330978|"     Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several     degenerative diseases, including retinopathies and glaucoma, however no previous safety study     involving humans has been conducted. The objective of this study is to evaluate effects of     autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal     bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse     effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence     tomography, and retinal ganglion cells function.   "
72946|NCT02330965|"     The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select     immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal     fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo     treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled     in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.   "
72947|NCT02330952|"     Primary objective:      The aim of this study is to determine the efficacy and safety of five days of oral     corticosteroids (40 mg / day) for the treatment of acute exacerbations of COPD (AECOPD) in     outpatients.   "
72948|NCT02330939|"     The purpose of this study is to determine whether dietary fats may affect postprandial     glycemic response differently according to their quality, and these effects may differ     whether they are assumed in the context of meals with high or low glycemic index in patients     with type 1 diabetes. This interaction between quality of fat and glycemic index of     carbohydrates may have clinical implication for the calculation of prandial insulin dose in     these patients.   "
72949|NCT02330926|"     Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle     mass (with or without loss of fat mass) that cannot be fully reversed by conventional     nutritional support and leads to progressive functional impairment.      There is an urgency for improving management, but there is no consensus on the optimal     treatment for cancer cachexia. Several single therapies for cancer cachexia have been     examined in clinical trials, with disappointing overall results. As multiple factors are     responsible for the development of cachexia, it has been argued that optimal cachexia     interventions should target all components: multimodal therapy for a multimodal problem.      The overall aim of this study is to early prevent the development of cachexia rather than     treatment late in the disease trajectory. From a patient perspective a short term effect will     be to improve physical and psychological function, to reduce symptom burden and to improve     survival. In other words live a longer and better life during and after chemotherapy. Direct     effects of the cachexia intervention are expected to be reduction of weight and muscle loss,     and improved physical activity and quality of life.   "
72950|NCT02330913|"     Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is     gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy     requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced     for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method     using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal     resection and closure of common entry hole after anastomosis) was performed with only one     stapler. Therefore, the novel method is simple and fast. Also, this new technique is better     economically than previously introduced anastomosis using linear stapler because lesser     number of stapler is required. We want to demonstrate the feasibility of novel intracorporeal     anastomosis method during laparoscopic total gastrectomy.   "
72951|NCT02330900|"     Evaluation of electromagnetic interference between modern cell phones and contemporary     implantable cardioverter defibrillators (ICDs)   "
72952|NCT02330887|"     In rural Nepal, the major drivers of underutilization of skilled birth attendance are     poverty, poor social support and inadequate birth planning. Drawing from similar programs     that have been shown to improve maternal and neonatal outcomes, we have designed a group     antenatal care program that uses a participatory learning and action process to engage women     in identifying and solving problems accessing maternity care services and create a supportive     social network. We plan to test a group antenatal care program that will change antenatal     care in three major ways: 1) conduct care in a group setting with women matched by     gestational age, 2) incorporate participatory learning and action, and 3) provide expert and     facilitated peer counseling.   "
72953|NCT02330874|"     In a recent study, which included 845 patients that at the time of ICU discharge had at least     one risk factor for readmission, the investigators' group developed a new readmission risk     score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely     measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention     Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the     investigators found that patients with a score above 14.5 had a high probability of     readmission.      The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a     tool to predict unplanned readmissions to the intensive care unit.      All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be     included in the study. The SD-ICU score is routinely calculated at the time of discharge from     the ICU. Patients will be divided into two groups: those with SD-ICU score> 14.5 (group 1)     and those with a score equal to or less than 14.5 (group 2). The two groups will be compared     with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic     regression will be used to investigate the association between the risk factors for     readmission used in SD-ICU score and ICU readmission as outcome.   "
72954|NCT02330861|"     Subjects are patients who are planned to do percutaneous coronary intervention for coronary     stenosis in the left circumflex artery without other stenosis in the left ascending artery     and the right coronary artery, or a patient with normal coronary artery. Immediately after     coronary angiography or percutaneous coronary intervention, the investigators will evaluate     for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary     pressure and flow velocity with Combowire in each coronary segment. Also, they will assess     coronary morphology by View It in each coronary segment.   "
72955|NCT02330848|"     Proposed is a randomized, controlled, modified Latin square parallel design study with two     treatment arms to examine walnut consumption effects on diet quality, body composition, and     markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A     modified crossover design (Latin square)27-29 will allow for both paired and unpaired     analyses.   "
72957|NCT02330822|"     This is a randomized controlled trial with a split mouth design. Patients with an indication     of lower dental extraction will be asked to join this research project at the Department of     Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose     case requires bilateral extraction, one side will serve as an experimental side, whereas the     other side will serve as a control.      Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic     acid will be injected following extraction in one of the two sides with random allocation.      cone-beam computerized tomography (CBCT) images will be taken for each participant     immediately post-extraction and at six months post-operatively.   "
72958|NCT02330809|"     The purpose of this study is to find out if drinking extra water helps people prevent or     relieve headaches and hunger and, if so, what volume of water is most effective and when is     it best to drink it?   "
72959|NCT02330796|"     A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial     designed to evaluate the safety and efficacy of two doses of Bucillamine compared with     low-dose Colchicine in the treatment of patients with acute gout flare.   "
72960|NCT02330783|"     There is no standard treatment in patients with renal cell carcinoma that was previously     treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a     randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib     versus sorafenib for the third-line treatment of patients with Metastatic renal cell     carcinoma.   "
72961|NCT02330770|"     Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in     women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing     hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa)     and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger     with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG   "
72962|NCT02330757|"     Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation     prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome     (PCOS)   "
73022|NCT02329964|"     This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that     is characterized by short operation time, required intense paralysis and ambulatory setting,     has not been investigated.   "
78397|NCT02259738|"     Human urinary kallidinogenase can promote the establishment of collateral circulation in the     ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then     increase the perfusion.   "
72964|NCT02330731|"     AIM: To compare between n-butyl-2-cyanoacrylate, iso-amyl-2-cyanoacrylate and mixture of 72%     chromated glycerin with hypertonic glucose solution in management of gastric varices.      METHODS: Ninety patients with gastric varices presented to Endoscopy Unit of Ain Shams     University Hospital were included. They were randomly allocated into three groups; each group     included 30 patients treated with intravariceal sclerosant injections in biweekly sessions     till complete obturation of gastric varices; Group I (n-butyl-2-cyanoacrylate; Histoacryl®),     Group II (iso-amyl-2-cyanoacrylate; Amcrylate®) and Group III (mixture of 72% chromated     glycerin; Scleremo® with glucose solution 25%). All the procedures were done electively     without active bleeding. Recruited patients were followed up for 3 months.   "
72965|NCT02330718|"     The purpose of this study is to elucidate the factors which are associated with the diagnosis     and predict prognosis and therapeutic targets by collecting specimens of tissue sample,     peripheral blood, and bone marrow aspirates at the time of diagnosis or relapse/refractory in     patients with malignant hematologic disorders except acute leukemia. This study is eligible     for patients who are diagnosed with malignant hematologic disorders except acute leukemia or     who will have diagnostic procedure with suspicion of having hematologic malignancy.     Prospective cohort is for patients who are not in treatment for hematologic malignancy.     Retrospective cohort is for patients who are diagnosed and in treatment.   "
72966|NCT02330705|"     Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG)     administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.   "
72967|NCT02330692|"     Developing a molecular genetic test that can identify prognostic factors which can predict     response to treatment, and to contribute to the establishment of future therapeutic     strategies base on prognostic factors by undergoing peripheral blood and bone marrow     examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.   "
72968|NCT02330679|"     Despite significant advances in pharmacological treatment, the global burden of depression is     increasing worldwide. The major challenge in antidepressant treatment is the clinicians'     inability to predict the variability in individual response to the treatment. The development     of biomarkers to predict treatment outcomes would enable clinician to find the right     medication for a particular patient at the early stage of the treatment and thus could reduce     prolonged suffering and ineffective protracted treatment. Brain imaging studies that examined     brain predictors of treatment response based on group comparisons have limited value in     classifying individuals as responders or non-responders. Machine learning classification     techniques such as the support vector machine (SVM) method have proven useful in the     classification of individual brain image observations into distinct groups or classes.     However, studies that have applied the SVM method to structural and functional magnetic     resonance scans (fMRI) involved small sample sizes and were confounded by placebo responses.     Furthermore, a recent meta-analysis of clinical trials and EEG studies have shown that early     clinical responses and brain changes at the early phase of antidepressant treatment may     predict later clinical outcomes suggesting that neural markers measured in the early phase of     antidepressant treatment may improve predictive accuracy. However, there is no fMRI study to     date that has examined the predictive accuracy of data obtained in early phase of the     treatment. We have preliminary fMRI data relating to early treatment response that form the     basis of this proposed study.      The main objective of this study is to use machine learning method to examine the predictive     value (sensitivity, specificity, accuracy) of resting state and emotional task-related fMRI     data collected at pre-treatment baseline (week 0) and in the early phase of antidepressant     treatment (week 2) in the classification of remitters (< 10 MADRS scores after 12 weeks of     treatment) and non-remitters in patients with major depressive disorder (MDD). A secondary     objective is to determine which data set (week 0 or week 2) gives the best predictive value.   "
72979|NCT02330536|"     Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing     all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated chest     cavity could increase lung collapse and improve surgical field view. The actual thoracic     pressure values may not be identical with the presetting on the insufflator display. This     overshoot pressure during VATS may compromise cardiac and pulmonary function. The purpose of     this study is to evaluate the effects of intrathoracic pressure overshoot during two-lung     ventilation on the hemodynamic and respiratory function and clarify the relative safety of     two different techniques of insufflation.   "
72969|NCT02330666|"     Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for     health problems that may compromise their futures and are extremely costly to society.     Positive parent-child communication, characterized by openness, satisfaction with the family,     caring, and effective problem-solving, has been found to be protective against a youth's     involvement in health-risk behaviors. To promote positive adult-youth communication, in     earlier work we developed, tested, and found efficacious an intervention, Mission Possible:     Parents and Kids Who Listen (MP). This study is designed to test the following hypotheses:     (a) Adults and youth who participate in MP will demonstrate more positive communication when     compared with adults who did not participate; (b) Youth who participate in MP will have a     lower incidence of health-risk behavior when compared with youth who did not participate; and     (c) Positive adult-youth communication will mediate childhood health-risk behavior in the     presence of risk processes that predict participation. The experimental design is a 2-group     (intervention and comparison) pre-test repeated measures design with six waves of data     collection over three years and two booster sessions of the intervention. Elementary school     and community centers in Madison and Chicago served as recruitment sites for parent-child     dyads.   "
72970|NCT02330653|"     The primary aim of this phase I/II, randomized, placebo controlled study is the assessment of     safety and tolerability of universal donor FMT compared to placebo in pediatric and young     adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) who have     have failed, are intolerant to, or have refused traditional first-line maintenance therapy.     Secondary objectives include the identification biomarkers in both donor and recipient that     may confer a clinical response and to establish whether or not ongoing FMT maintenance     therapy is required for maintenance of clinical benefit in pediatric UC.   "
72971|NCT02330640|"     This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid     dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients     undergoing CABG surgery.   "
73093|NCT02329041|"     Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for     double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor     double-lumen tube intubation. In this study, we will investigate its role in double-lumen     tube intubation by comparison with another videolarygoscope.   "
72973|NCT02330614|"     128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental     School, Universidad de Chile, were included in the study. 58 patients were bleaching     (experimental group) and 70 patients don't accepted the bleaching procedure (control group)     were included in this study and signed a consent form.Experimental group Patients who agreed     to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to     each subject With verbal instructions for 3 weeks with daily applications of 1 hour according     to manufacturers indications , before and after this procedure was applied again the NEO-FFI     personality test form, had 30 minutes to answer it.Control group:Patients who refused to be     bleached were administered the personality test NEO-FFI, had 30 minutes to answer it.   "
72974|NCT02330601|"     The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up     to 60% of patients had stone recurrence within two years after stone retrieval by ERCP.     Although EPLBD is useful for for extraction of large CBDS with less operation time and     mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients     with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term     recurrence of CBD stones in patients with previous ES. It is a retrospective study with a     small sample size (n=94).      Here a prospective, randomized controlled study including two tertiary centers was designed.     The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in     patients with recurrent CBDS.   "
72975|NCT02330588|"     Childhood obesity is an urgent public health issue. Roughly one-quarter of Canadian children     are overweight, putting them at risk for chronic diseases. Because most families access     health services in primary care, it is an ideal venue for obesity prevention. Specifically,     programs in primary care can prevent unhealthy weight gain in healthy weight children     (primary prevention) AND reduce unhealthy weight gain in children who are already overweight     (secondary prevention). Parents play a key role in children's health, so it is vital to     include parents in strategies to prevent childhood obesity.      The following objectives of this study are to: (i) develop a web-based, brief program for     parents as an educational tool to motivate parents to support healthy lifestyles in children,     and access community resources and health services that can prevent childhood obesity; (ii)     assess the acceptability of the program using focus groups with parents, and     pediatric-focused health care professionals, trainees, and administrators; and (iii) recruit     parents (n=200) in primary care and collect data at baseline and 1-month follow-up to explore     if the program led to changes in parents' motivation to support their children's lifestyle     habits, and families' use of resources and health services to prevent childhood obesity.      It is hypothesized that the developed screening, brief intervention, and referral to     treatment (SBIRT) will (i) encourage parents of healthy weight children to seek resources to     eat healthfully and be physically active to maintain their weight status (primary [1°]     prevention), and (ii) guide parents of unhealthy weight children to access educational tools     and community services to reduce their child's obesity and associated health risks (secondary     [2°] prevention).      By providing families with tailored feedback, practical educational tools, and information on     local health services, this research will help to address oft-cited barriers primary care     clinicians commonly report when providing effective obesity-related health services, and     encourage family self-management of obesity-related behaviors.   "
72976|NCT02330575|"     The purpose of the study is to examine the benefit and specific outcomes of a community-based     exercise program that is designed to address the needs of individuals who are receiving or     recovering from cancer treatment.      Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study.     Survivors will be randomly assigned to one of two groups. The first group will take part in     an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based     exercise (early exercise group). The other 40 participants will continue with their normal     activities for 16 weeks (delayed exercise group). After the 16 week period, participants in     the delayed exercise group will take part in the 8-week supervised exercise program.      Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise     sessions will be supervised by specially trained exercise specialists who have received     special training in exercise and cancer.      Outcomes of the study will include feasibility, physical fitness measures, cancer-related     symptoms and quality of life.   "
72977|NCT02330562|"     This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ)     and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma. The     study population includes subjects who are in first or second relapse and who have not     previously received any bevacizumab or other anti-angiogenic agent or proteasome inhibitor     for treatment of malignant glioma. Phase 1 evaluates the combination of MRZ and BEV, while     Phase 2 evaluates single-agent MRZ. Part 3 (Phase 2) includes a combination MRZ using     intra-patient dose escalation, and BEV at a fixed dose.   "
72981|NCT02330510|"     The prevalence of both Alzheimer's Disease (AD) and stroke doubles each decade over 65 years     old. Both are major causes of dementia, currently estimated to affect 46 million people     worldwide. The current costs globally are $818 billion. Additionally, in population studies     elders over 65 years, covert cerebral small vessel disease appears on MRI scans as silent     lacunar infarcts in 25% as Microbleeds in 10%, and as focal or diffuse 'incidental' white     matter disease (WMD) in 95%. WMD is extensive in 20%, with a clinical threshold effect around     10cc2. Small vessel disease is even more common in dementia, often coexisting with AD and     independently contributing to cognitive decline and progression to dementia. Longitudinal     imaging using cerebral amyloid labeling opens a new opportunity to understand the     additive/interactive effects of small vessel disease and AD.      The design of this study includes recruitment of two cohorts, including Mild Cognitive     Impairment (MCI) and/or early Alzheimer Disease subjects from memory clinics and subjects     with strokes/TIA from stroke prevention clinics. Inclusion criteria include the presence of     moderate/extensive white matter disease, eg. Fazekas score of 2 (with confluent     peri-ventricular hyperintensities) or Fazekas score of 3, as determined by previous MR or CT,     > 60 years of age, Mini-Mental Status Exam (MMSE) scores ≥ 20. Subjects will undergo 3T     structural MRI (including T1, PD/T2, FLAIR, GRE, DTI, ASL, and resting state fMRI), glucose     PET, amyloid PET (using AV-45 florbetapir) and neuropsychological testing, as well as blood     sampling. Repeat MR and PET/CT imaging and neuropsychological testing will be conducted at 24     months. The imaging portion is designed to closely parallel the Alzheimer's Disease     Neuroimaging Initiative (ADNI) in order to benefit from the availability of both cognitively     normal controls (NC), MCI and Alzheimer's disease subjects with minimal WMD.   "
72982|NCT02330497|"     Advances in conventional imaging (abdominal ultrasound, CT scan, MRI) are so great that     chance to discover a incidental solid or cystic pancreatic lesion is becoming usual.     Endocrine tumors have variable malignant potential depending on their size, some malignancy     for lesions larger than 2 cm and indefinite for a smaller size. The branch-duct like IPMN     (intraductal papillary mucinous pancreatic tumor) involving the pancreatic secondary ducts     represent half of pancreatic cystic tumors and may degenerate into 5 to 10% of cases. Signs     and risk of degeneration are the presence of mural nodules greater than 5 mm and size > 3 cm,     although the latter criterion is discussed. Mucinous cystadenomas could degenerate between 30     and 50% of cases even though the role of size is much discussed (<4 cm). The follow-up     imaging is performed using MRI and endoscopic ultrasonography (EUS). A fine needle aspiration     for cytology and histology is possible and determination of biological markers is useful. But     cytology is often unprofitable due to the poor cellular profile of the cystic pancreatic     tumor. Once the diagnosis of suspected malignancy, the patient should be referred to the     surgeon for pancreatic resection more or less extensive. But this attitude is facing a     significant operative risk with up to 30% of morbidity and mortality between 1 and 3 % for     cephalic resections. Some patients with high post operative risks are inoperable. For these     reasons, some teams have proposed the destruction of the walls of the cyst under EUS, US or     CT control by washing with absolute alcohol content of cystic tumor.      An interesting alternative endoscopic destruction would be the use of radio frequency     ablation technique (RFA). RFA is a recognized technique for local tumor destruction by     delivering thermal energy to obtain coagulation necrosis of the lesion. Taewong Medical ™     recently developed a radiofrequency needle EUSRA® coupled with a combo VIVA ™ generator for     applying RFA sub EUS control. But no prospective study is available at this date regarding     the treatment of the cystic or solid tumoral pancreatic lesion with this technique. The     primary endpoint of the present study is to investigate the feasibility and safety of this     guided radiofrequency probe EUS for the treatment of pancreatic endocrine tumors or     inoperable pancreatic cystic tumors. The secondary objective will be the efficiency.   "
72983|NCT02330484|"     Based on patients' HbA1c improvement, this study aims to establish an incentive strategy to     family physicians and patients respectively to evaluate the affect on the adherence to     medication among patients with type2 diabetes.   "
72984|NCT02330471|"     In a randomized clinical trial of 120 women undergoing large loop excision of the     transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray     versus forced coagulation, will be compared. The primary outcome of the study is time to     complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain,     and postoperative bleeding complications.   "
72985|NCT02330458|"     Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness     and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to     predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's     Disease.   "
72986|NCT02330445|"     Part A Primary Objective To determine the safety of six months of PRTX-100 administration.     Part B Primary Objective To obtain antisera from normal volunteers that have developed     anti-PRTX-100 antibodies.      Secondary Objective(s) To assess rheumatoid arthritis activity during the period of PRTX-100     treatment To evaluate the development of anti-PRTX-100 antibodies To explore feasibility of     joint evaluations with ultrasound To explore feasibility of biomarkers as disease markers   "
72987|NCT02330432|"     Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may     play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in     restoring immunity, thereby improving outcomes in patients with severe sepsis.      In this randomized trial, the investigators propose to evaluate the efficacy of Mw in     patients with severe sepsis.   "
72988|NCT02330419|"     This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of     naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially     diverse participants will be recruited using Respondent Driven Sampling as well as active     field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug     dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys     will be completed monthly.   "
72989|NCT02330406|"     The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in     reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and     cardiovascular risk factors on statin.   "
72990|NCT02330380|"     This is a prospective longitudinal observational pilot study of psoriasis patients on     continuous standard-of-care systemic therapeutics to determine the level of change in     established (plasma/serum) and investigative (cellular) biomarkers that are associated with     increased risk of CVD events.      The final endpoint of the proposed study will be a ranking of the examined biomarkers based     upon an integrated assessment of biomarker behavior over time.      Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI,     skin biopsies, and clinical improvement.   "
72991|NCT02330367|"     AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that     selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing     wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and     safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or     recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010     in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.   "
73105|NCT02328885|"     Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety     and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists     of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20     fraction (between 60 and 90 days after transplantation).   "
72992|NCT02330354|"     The purpose of this study is to evaluate the effect of a 7-month social marketing program -     Healthy Me, Healthy We (previously called Our Year of Healthy Living) - in improving     preschool children's (3-4 years) diet and physical activity behavior. Healthy Me, Healthy We     will use social marketing approaches in the child care center to promote the use of healthy     diet and physical activity behaviors by children, as well as their teachers and parents. The     program will use visual cues, educational materials, activities, and a song to deliver     targeted healthy behavior messages that connect the teacher, child, and parents. Centers will     implement the Our Year of Healthy Living program in their classrooms over the course of a     school year (October-April). Prior to initiation and after completion of the program,     researchers will collect information about diet, physical activity, child body mass index     (BMI), and center and home environment information from participants. From the beginning of     the program to the end, children enrolled in the program will have 1) a greater increase in     physical activity and decrease in sedentary time, 2) improved diet, and 3) smaller increase     in body mass index compared to children in centers that do not complete the program.     Additionally, from the beginning of the program to the end, homes and centers that     participate in the program will have greater improvements in scores on the home and center     environment assessments compared to centers and homes that do not participate.   "
74533|NCT02310178|"     The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by     several types of bariatric procedures. In addition, this study could lead to the development     of clinical trials on assessment of the bariatric surgery impact.   "
72993|NCT02330341|"     The term prediabetes has been used to encompass the first alterations on glucose metabolism     such as impaired fasting glucose and glucose intolerance, and its early detection and     treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease     worldwide.      Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the     treatment of diabetes.      Different in vitro and in vivo studies have shown that Artemisia dracunculus increases     insulin signaling and improves insulin sensitivity.      The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance,     insulin sensitivity and insulin secretion.   "
72994|NCT02330328|"     This is a randomized controlled, multi-center, non-blinded non-inferiority study examining     the utility of telemetry monitoring in patients admitted who are low risk for acute coronary     syndrome. Each of the six sites will prospectively enroll 250 patients in each arm of the     study randomized to either a med-surg bed (no telemetry) or a telemetry bed during their     admission. Research study coordinators will enroll patients and then follow them throughout     their hospital course and record primary and secondary end point events.      The research coordinators will collect information on the following items for data     collection: age, gender, smoking history, history of hypertension, history of diabetes     mellitus, history of hypercholesterolemia, and history of family member with early heart     disease or myocardial infarction, and body mass index. Research coordinators will document if     the patient had any of the following events during their hospital course: death, myocardial     infarction (MI), upgrade to a higher level of care, dysrhythmia, results of any stress     testing or cardiac catheterization. In addition patients will be contacted at 30 days and 365     days to inquire about MI, needing for percutaneous coronary intervention (PCI), or     revascularization (CABG).      Based on previous studies, we hypothesize that patients aged 18-49 years who are at low risk     for Acute Coronary Syndrome (ACS) are unlikely to benefit from continuous heart monitoring     while admitted to the hospital for chest pain. We suspect that the rate of significant events     may approach zero in this group of participants. This study aim is to show that a bed without     remote monitoring- telemetry- is adequate when these low risk participants with chest pain     are hospitalized.   "
72995|NCT02330315|"     The purpose of this study is to investigate the effects of transcranial direct current     stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and     functional limitations in people with osteoarthritis of the knee. The investigators     hypothesize that there will be a decrease in pain levels with active stimulation, when     compared to sham stimulation.   "
72996|NCT02330302|"     Hip fractures are common in our elderly population and is associated with pain before and     after surgery. The current pain management for patients who have undergone surgery for hip     fractures include a combination of oral painkillers, opioids (eg morphine) and regional     anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves     supplying the hip joint to numb the operation site. As opioids have many side effects,     especially in the elderly patients, regional anaesthesia techniques can help to reduce the     use of opioids and the related side effects. This may enhance their recovery and length of     hospital stay   "
72997|NCT02330289|"     Studies suggest that some laboratory tests ordered for hospitalized patients are duplicative     or have limited value. This study will evaluate a normative feedback intervention to reduce     overuse of laboratory tests for hospitalized patients by internal medicine     physicians-in-training.   "
72998|NCT02330276|"     Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.   "
72999|NCT02330263|"     Surgical stress creates a state of insulin resistance which has been related to increased     postoperative complications. Fasting before surgery induces a catabolic state that     contributes to the development of insulin resistance. The aim of this study is to evaluate     the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients     undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79     years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30)     groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml     carbohydrate beverage in the evening before surgery and in the morning of the operation day     (3 hours before their scheduled operation). In contrast, patients in the control group     consume no food or drink after midnight before their surgery. The primary endpoints are     postoperative insulin resistance measured by short insulin tolerance test.   "
73000|NCT02330250|"     This project aims to improve adherence rate through pharmaceutical care in patients with     systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve     the quality of life of these patients.   "
73001|NCT02330237|"     The aim of the study is to evaluate the safety and the therapeutic activity of the     combination of Natural Gel combination and hair mask of plant origin in patients with mild to     moderate plaque psoriasis.   "
73002|NCT02330224|"     High blood pressure (BP) is a serious public health problem responsible for heart attack,     stroke and kidney failure. One in four adults in Singapore has hypertension. We propose a     pilot study in 2 polyclinics in Singapore, 1 deliver a structured multi-component     intervention and another usual care. A total of 100 adults with uncontrolled high blood     pressure will be followed for 3 months. The intervention includes 1) algorithm-driven     antihypertensive treatment for all patients using fixed-dose combination and lipid lowering     for high risk patients, 2) motivational conversation for high risk patients; and 3) telephone     based follow-ups of all patients by a team of physician supervised nurse practitioners and     nurses. The change in BP will be compared between intervention and control groups. The     structured care including the above mentioned components is likely to be more effective than     usual care in lowering BP levels of patients with uncontrolled high blood pressure. Such a     program is also likely to be more cost effective in terms of money spent for improving     quality of patients' life. The findings of the pilot will inform the design of a larger     cluster randomized trial in eight polyclinics in Singapore. If the main study is successful,     the findings will be informative for policymakers to roll out intervention in all polyclinics     and primary care centers across Singapore, and other countries with similar healthcare     infrastructure.   "
73103|NCT02328911|"     The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of     a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The     hypothesis is that laser therapy will produce significant improvement on measures of     self-reported pain among adults with diabetes.   "
73003|NCT02330211|"     The primary aim of this phase I/II, randomized, placebo controlled study is the assessment of     safety and tolerability of universal donor FMT compared to placebo in pediatric and young     adult subjects (ages 5 years through 30 years) with active Crohn's colitis (CD) who have     failed, are intolerant to, or have refused traditional first-line maintenance therapy.     Secondary objectives include the identification biomarkers in both donor and recipient that     may confer a clinical response and to establish whether or not ongoing FMT maintenance     therapy is required for maintenance of clinical benefit in pediatric CD.   "
73004|NCT02330198|"     The purpose of this study is to validate the Foot and Ankle Ability Measure in Finnish.   "
73005|NCT02330185|"     The most used anatomical landmark for application of spinal anesthesia is Tuffier's line.     Other alternative landmark is tenth rib. However there is no trial that compare these     landmarks based on using ultrasonography.   "
73006|NCT02330172|"     This study aims to make a comparison of surgical condition and recovery time between     rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.   "
73007|NCT02330159|"     Pilonidal disease (PD) is a chronic disease with a major impact on patient quality of life     and productivity. Thus, wound healing would have a significant effect on patient quality     outcomes, patient quality of life, and healthcare utilization, as well as societal benefits     from allowing this vital population to return to productivity. There is no consensus on     postoperative wound care after surgery for PD. Negative pressure therapy is commonly used.     However, this therapy is costly and cumbersome, and not evidence-based to optimize wound     healing or postoperative patient or financial outcomes. The investigators goal is to     investigate the impact of MatriStem® Wound Matrix and MicroMatrix® (ACell, Inc., Columbia,     MD) on pilonidal wound healing. Secondary goals are to evaluate the impact of MatriStem Wound     Matrix and MicroMatrix on postoperative outcomes, quality of life, and healthcare costs after     surgical management of pilonidal disease.   "
73008|NCT02330146|"     The primary purpose of this study is to assess the safety profile of RCT-01 injections as     compared to placebo injections. This study will also measure the impact these injections will     have on tendon structure and function and the symptoms of Achilles tendinosis.      28 participants will be selected for this study based on their health status, current/past     medications, and ability to adhere to protocol-related requirements. Prior to entering the     screening phase of the study, all potential study participants will have had to have at least     3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles tendinosis     directed by a certified physiotherapist without a clinical response. At the first visit and     after providing informed consent participants are evaluated against the study     inclusion/exclusion criteria and provide blood samples for screening assessments (including     virology). If suitable for study participation, participants will provide a biopsy from the     scalp from which RCT-01 will be prepared.      Baseline evaluations of participants' overall health and tendinosis, in particular, will be     performed on the day of injection. Once all baseline assessments have been completed, the     tendon to be treated will be anesthetized and will receive ultrasound-guided injections of     either placebo (cryomedium) or RCT-01.      All participants will return to the clinic for repeat assessments of their unilateral     Achilles tendinosis and overall health at seven (7) visits over the following 6 months.     Participants will also complete an eccentric training physiotherapy program under the     guidance of a certified physiotherapist for two (2) months after receipt of injections. Total     duration of patient participation is approximately eight (8) months.   "
73009|NCT02330133|"     Mid-life women, aged 35-50, are currently an underserved population in the areas of     unintended pregnancy and STI prevention interventions. Common perception is that women in     this age range are no longer sexually active, or are past the menopause transition, but in     reality, sexual activity remains stable through mid-life and into the post-menopausal years.     Additionally, physiological and relationship status changes (e.g. divorce or death of a     partner) put these women at increased risk for both unintended pregnancy and STI's. This     project developed and evaluated a theoretically-based multimedia intervention designed to     assist mid-life women in protecting themselves from sexually transmitted infections and     unintended pregnancy.   "
73010|NCT02330120|"     The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary     mechanics in intensive care patients.   "
73044|NCT02329678|"     Introduction: The present clinical trial was conducted to evaluate the efficacy of membrane     barrier in the healing of apicomarginal defects.      Methods: Thirty patients meeting inclusion criteria were selected and allocated randomly into     two groups: collagen membrane group and control group. Clinical and radiographic measurements     were recorded during follow up at regular intervals of 0, 3, 6, 9, and 12 months after     surgery. The criteria for success included the absence of clinical signs and symptoms, and     complete or incomplete radiographic healing.   "
73011|NCT02330107|"     Lower urinary tract symptoms (LUTS) represent a widespread health problem that negatively     affects the quality of life (QoL) of majority of the male aging population. Although LUTS are     not life threatening, these symptoms include urinary retention, voiding difficulty, frequent     feeling of urinary urgency, and nocturia, all of which negatively affect the daily functions,     sleep quality, and sexual activities of patients. Despite the proven effectiveness of     conventional pharmacological therapies, most men are reluctant to try these treatments     because of perceived side effects and potential complications. Other non-invasive     complementary treatments for LUTS should be explored because of the limitations of     pharmacological therapy.      Auriculotherapy (AT), one of the approaches in traditional Chinese medicine, is a therapeutic     method in which specific points in the auricle are stimulated to treat various physical     disorders. AT is a specialized form of acupuncture in which the ear is viewed as a     microsystem of the body. A minimally invasive measure of AT, instead of using needles, is     adopted in this study to avoid pain induction.      This randomized controlled trial (RCT) aims to determine the effectiveness of AT in improving     the conditions of the elderly with LUTS in terms of symptom relief, enhancing QoL, and     improving sleep conditions. Male subjects, who are 60 years old or above and with moderate to     severe LUTS, will be recruited.      Subjects in 'Treatment arm 1' will receive MAT and placebo LA on specific auricular points on     one side of the ear during each treatment session. Subjects in 'Treatment arm 2' will receive     LA and placebo MAT using low-energy laser applied to selected acupoints of the ear, and a     plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given.     Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LA). Subjects in     the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered     to affect LUTS will be selected. Only one ear at a time will receive treatment. Thus, the     ears will be treated alternately. The total treatment period will be four weeks. The     experimental objects will be replaced every other day. Therefore, treatment will be performed     thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This     study can advance our knowledge of complementary approaches to improve the LUTS conditions of     the elderly population and the feasibility of AT among clients with LUTS in a future     large-scale study.   "
73012|NCT02330094|"     The purpose of this study is to see how much gabapentin will reduce headaches associated with     subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication     prescribed.   "
73049|NCT02329613|"     The main objective of this study was to evaluate and compare 6-month calorie intakes between     a group of patients receiving a standard dinner and a group of patients whose evening meal is     improved; compliance will be assessed on a food card with 5 levels of consumption: no (0%),     25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per     month for 6 months and will, from the total calorie intake of each dish, estimate calorie     intake ingested per day on all meals of the day.   "
73013|NCT02330081|"     A total of twelve healthy volunteers will donate one unit of fresh whole blood. This unit     will be treated with the Mirasol Pathogen Reduction Technology for Whole blood and then     stored for 24h. At the end of storage, platelet concentrates will be separated from the unit,     tested for key in vitro parameters and radiolabeled. On the same day (so 24h after the     donation of whole blood), the volunteer will donate a fresh sample of whole blood. Platelets     will be separated from this fresh sample and labeled with another radio-isotope. Then, the     two radiolabeled platelet aliquots will be infused simultaneously and the recovery and     survival of the two types of platelets will be measured.   "
73014|NCT02330068|"     The purpose of this study is to evaluate the feasibility of developing a microbiome probe of     depression and to evaluate the microbiome change in a preliminary analysis of treatment     response (n=20) vs. non response (n=20) to the antidepressant citalopram. This study is a 12     week open trial that will enroll approximately 80 participants (anticipated 40 study     completers with paired biomarker data) with an episode of major depression, Bipolar I or     Bipolar II and 40 age- and sex-matched healthy controls.   "
73015|NCT02330055|"     The primary aim of the study is to evaluate the effect of the method of delivery (vaginal     delivery vs. cesarean section) on oxygen saturation in the first postpartum night. The     investigators hypothesize that nocturnal desaturation occurs more frequently in cesarean     section compared with vaginal delivery, expressed as either the duration of SpO2 below 90% or     the Oxygen Desaturation Index (ODI). The ODI is defined as number of oxygen desaturations by     at least 3 % per hour. Furthermore, the investigators expect a higher pulse rate and a lower     mean and minimum SpO2 in the cesarean section group compared with the vaginal delivery group.      The secondary aim of the study is to investigate how the upper body position during sleep (45     degree elevated vs. non-elevated) affects the oxygen saturation during the first postpartum     night.      The investigators hypothesize that an upper body elevation to 45 degrees decreases the     incidence of desaturation events, expressed as either the duration of SpO2 below 90% or the     ODI , compared with a non-elevated body position within each delivery group (vaginal delivery     or cesarean section).      The third aim of the study is to identify independent predictors of nocturnal desaturation in     postpartum women. To that end, the investigators will administer questionnaires and collect     demographic and clinical data according to various obstructive sleep apnea screening scores,     including the P-SAP, STOP-Bang, and Epworth Sleepiness Scale. The investigators will also ask     the patient to rate the pain during the study night on a verbal numerical rating scale.   "
73016|NCT02330042|"     Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated     with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the     United States. Standard optical coherence tomography (OCT) cannot directly detect vascular     changes, which may occur early affecting the passage of blood through the tiny capillaries     (reduced capillary flow) or cause the greatest damage through formation of abnormal blood     vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold     standard for detecting these changes, but FA requires an injection of a dye into the vein of     the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been     used to make functional measurements (such as total retinal blood flow among others) and to     perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate     diabetic retinopathy.   "
73017|NCT02330029|"     The purpose of this study is to test the onset of action, offset of action, efficacy, and     safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long     term (over one year). Pinaverium has been in many countries, but there is no randomized,     double-blind, large sample size, and placebo-controlled study on this medication yet. Tong     Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used     traditional Chinese medicine that can be used for IBS. The hypothesis is that the two     remedies are effective and safe for IBS treatment with no significant different onset and     offset of actions when tested by modern clinical standards and criteria.   "
73045|NCT02329665|"     The primary objective of this study is to collect CT images of patients undergoing CT Guided     Needle Intervention Procedures which will be used for the development of the NeedleWaysTM     System.   "
73018|NCT02330016|"     This is a single center study of the safety and efficacy of Juvedérm Voluma for the treatment     of hypognathism.      Each qualified subject will undergo treatment with Juvedérm Voluma in the anterior and     lateral chin for volume correction. Prior to treatment, the principal investigator will     evaluate the severity of chin recession using a 90 degree image and a goniometer to measure     the angle from the glabella to the chin. Subjects will be eligible for injection if the angle     measures between 145 - 160 degrees. Facial digital photography will be captured prior to     treatment and at each subsequent visit. The subject will complete a safety and injection site     response (ISR) diary beginning on the evening of treatment.      The subject will return at Day 3 and Day 14 after initial treatment, at which time the     subject will undergo photography and the investigator will rate treatment improvement (GAIS).     An independent image analysis technician will assess the degree of correction. The     investigator will evaluate the treatment area for any adverse events (AEs).      The subject will return 30 days after initial treatment, and the principal investigator will     determine if a touch-up treatment is warranted. If deemed necessary, a touch-up treatment may     be administered. Facial digital photography will be captured prior to treatment and following     treatment. The subject will return 3 days after the touch-up to undergo digital photography     and for the principal investigator to assess safety/improvement.      After initial or touch-up treatment, whichever is last, routine follow-up visits for safety     and effectiveness will occur at 1 (30 days), 2, 4, 6, 9 (telephone call only) and 12 months.     At all follow-up visits, facial digital photography will be captured and the investigator     will rate treatment improvement (GAIS).. At screening and at Months 1, 2, 4, 6 and month 12     subjects will complete the satisfaction of face overall module of the FACE-Q questionnaire.      The goal of this study will be to assess the feasibility of Voluma XC for the treatment of     hypoplastic chins   "
73019|NCT02330003|"     The purpose of this study to evaluate the safety of IL-YANG Inactivated Split Influenza     Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled     Syringe (inactivated split influenza vaccine) after single-dose intramuscular administration.   "
73020|NCT02329990|"     Phosphorus is a mineral that is naturally present in our foods and is required by our bodies     for normal function. It has been found that phosphorus supplementation taken before meals has     the potential to reduce meal size. However its long term effect has not been measured yet. It     is well accepted that changes in body weight require about 3 months. Using body weight as the     outcome, which is the ultimate outcome of weight loss approaches, would provide robust     information on the role of phosphorus.   "
73021|NCT02329977|"     ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However,     4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation     due to chronic inflammation of biliary duct is generally considered an important cause of     CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy.     Although it was believed that DBR was the important cause of CBDS recurrence, the direct     evidence was still lacking. Here we conducted a case control study to investigate the DBR     rate in patients with recurrent CBDS after ERCP.   "
73023|NCT02329951|"     In this study, we are attempting to determine which factors are associated with     interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP     who are considered to be good candidates for therapeutic interventional procedures will be     given a complete history and physical exam, which includes the assessment of Waddell signs,     and querying them regarding factors shown in non-interventional studies or retrospective     studies evaluating interventional treatments to be associated with negative treatment     outcomes. These factors include the presence of Waddell and other physical exam signs, opioid     use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale on     expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation),     procedure-related pain, obesity, and smoking history. They will then proceed to undergo their     scheduled intervention, which will be limited to epidural steroid injections (ESI), facet     blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint injections. A     positive outcome will be defined as > 50% pain relief based on average pain score at 1-month     and a score of at least 4 on a 1-5 Likert satisfaction scale. Those with a positive outcome     at 1-month will remain in the study and be followed again at 3-months.   "
73024|NCT02329938|"     Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced     as a pure tissue repair with no need for mesh. In other words; the complications which may     arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the     efficacy of this new repair and compare it to the standard Lichtenstein repair.   "
73025|NCT02329925|"     The coordination of swallowing and breathing is an important mechanism because the route for     air and deglutition is partly shared in the pharynx. Tongue Stabilizing Device (TSD) is a     preformed appliance for Obstructive Sleep Apnea (OSA) that protrudes the tongue and improves     upper airway structure and function during sleep. Investigators will attempt to assess     efficacy of TSD therapy on OSA and the physiological change of swallowing and breathing     routes in OSA patients during sleep.   "
73026|NCT02329912|"     Postoperative ileus (POI) is a frequent complication after abdominal surgery leading to     nausea, vomiting and infectious complications. Bowel dysmotility can last for days and     necessitates parenteral nutrition resulting in an prolonged hospital stay and a high economic     burden.      Until now there is no evidence based therapy of manifest POI because of missing valid     surrogate markers demonstrating the severity and resolution of POI.      A novel tool to examine gastrointestinal function is the SmartPill®. By measuring pH value,     temperature and intraluminal pressure the capsule is able to analyse gastric emptying, small     bowel transit, large bowel transit and peristaltic activity.      Unfortunately the use of the SmartPill® is not allowed in the first three months after     abdominal surgery. Therefore a trial is needed to investigate the behaviour of the SmartPill®     during its passage through the human gastrointestinal tract immediately after surgery.      The primary endpoint is      - to investigate the safety of the SmartPill® in patients after abdominal surgery.      The secondary endpoints are:        -  is the SmartPill® able to detect the gastrointestinal transit and the peristaltic          activity followed by abdominal surgery compared with patients which underwent          thoracic/vascular surgery.        -  is it possible to correlate the measured parameters (delayed gastrointestinal transit,          lack of peristalsis) with the clinical signs of POI (nausea, vomiting, prolonged          duration until first postoperative defecation).        -  is the detected peristaltic activity influenced by intravenous applicated prokinetic          drugs        -  is the detected peristaltic activity influenced by physiotherapy      Using those endpoints the investigators hope to demonstrate the safety of the SmartPill®     after abdominal surgery, to evaluate its ability to analyse severity and length of POI and to     examine whether the used prokinetic drugs and postoperative mobilization are able to     influence peristaltic activity.   "
73027|NCT02329899|"     Observational study aimed at evaluating the clinical impact of a standardised diagnostic     procedure for the investigation of patients with suspected mild bleeding disorder (MBD).   "
73028|NCT02329886|"     China, efforts are underway to respond to an unprecedented epidemiologic transition, with     soaring rates of cardiovascular disease (CVD), including heart disease and stroke. Yet there     may be limitations in translating observations and findings derived from Anglo-based     population studies. As such, there is a critical need for population-based studies that     provide insight into the risk factors, incidence, and outcomes of CVD in China. The Qingdao     Port Health Study is a population-based prospective cohort study of employees of the Qingdao     Port Group, China, designed to investigate the burden of CVD and risk factors (e.g.,     sociodemographic, biological, environmental and clinical factors) associated with disease     onset and outcomes.   "
73046|NCT02329652|"     This study is to evaluate the use of a fully implanted device for providing hand function,     reach, and trunk function to individuals with cervical spinal cord injury.      Funding Sources:      FDA OOPD NIH NINDS   "
73029|NCT02329873|"     The purpose of this randomized controlled trial was to evaluate the effects of a respiratory     rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum     expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive     pulmonary disease (AECOPD). Using purposive sampling, 61 participants were recruited and     randomly assigned to either the experimental group (n = 30) or the control group (n = 31).     The experimental group participants received the respiratory rehabilitation exercise training     twice a day and 10-30 minutes per session for four days. The control group participants     received usual care and health education. Data were collected at baseline and at the end of     the four-day intervention.   "
73030|NCT02329860|"     This was a multicenter, randomized, double-blind, phase III trial. This clinical study     evaluates the efficacy and safety of Apatinib in patients with advanced liver cancer who have     progressed on Systemic Therapy (Chemotherapy and/or Targeted Therapy).      Approximately 400 patients who meet the entry criteria will be randomly assigned in a 2:1     ratio to Apatinib or placebo (1/3 chance to receive placebo).      Primary endpoint of the study is overall survival.   "
73031|NCT02329847|"     The purpose of this study is to determine the safety and to establish the recommended phase 2     dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic     lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL)     and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will     be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety     in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.   "
73050|NCT02329600|"     The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral     lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen     planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.   "
74559|NCT02309840|"     The purpose of this study is to examine the impact of introducing healthier, chef-enhanced     foods and/or environmental modifications (choice architecture) on selection and consumption     of school foods among elementary and middle school students.   "
73032|NCT02329834|"     The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous     and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent,     they are both expected to achieve therapeutic plasma levels and induce effective diuresis.      The test formulation in this study is a buffered solution, Furosemide Injection Solution at 8     mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the     instructions in the protocol. A commercial formulation of Furosemide Injection, USP will     serve as the reference drug in this study, which will be administered by IV bolus. It     contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV     and IM injection.      The objectives of this study are:        -  To characterize the pharmacokinetics of furosemide administered by continuous          subcutaneous infusion using a biphasic delivery profile.        -  To estimate the absolute bioavailability of furosemide administered by continuous          subcutaneous infusion compared with an equivalent dose of furosemide administered by          intravenous bolus administration.   "
73033|NCT02329821|"     The investigators are trying to investigate metabolism of lactate sourced from IV Hartmann's     solution in patients with hepatocellular carcinoma(HCC) compared with a control     group(donation for liver transplantation) with normal liver function. Second purpose of this     study is finding the predictive factor of changing metabolism of lactate sourced from IV     Hartmann's solution in patients with HCC.   "
73034|NCT02329808|"     This is a clincial validation study of a dried blood spot (DBS) method for the analysis of     immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring     (TDM) in a pediatric population.      The primary goal is to clinically validate a finger prick DBS method compared to conventional     venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the     pediatric population. Secondairy goals include feasibility of the finger prick DBS method in     the target population, to design an inventory of costs that will be incurred in future     health-economic analyses and to construct a population PK model based on the available data     collected for the primariy goal.   "
73035|NCT02329795|"     This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used     to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and     radiation treatment.   "
73036|NCT02329782|"     Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence     intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the     purpose of achieving and sustaining optimal levels of ART adherence and virologic     suppression. Eligible participants will be randomized to receive either the ARP intervention     or usual care (no intervention) and followed for 24 months.   "
73037|NCT02329769|"     The purpose of this study is to see whether PRO044 is safe and effective to use as medication     for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA     for the dystrophin protein.   "
73038|NCT02329756|"     The objective of this study is to investigate the effect of tranexamic acid (TXA)     administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly     Adherent Placenta (MAP; placenta accreta, increta, percreta).   "
73039|NCT02329743|"     The primary objective of this study is to assess the efficacy and safety of 2 concentrations     of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of     ocular inflammation and pain in subjects undergoing cataract surgery.   "
73040|NCT02329730|"     Choose healthy subjects and patients with TB, distribute them into different dose groups     according to the recombinant EC allergen dose from low to high average. Conducting clinical     trials of TB-PPD or placebo as controlled arms intradermal injection. Do specific interferon     gamma detection before the skin test，after the test 72h±2h and 144h±2h. Evaluate the safety     of the recombinant EC allergy , and provide the appropriate dose range for phase IIb clinical     trials.   "
73041|NCT02329717|"     This study evaluates the efficacy and safety of PBI-05204, an extract of the leaves of Nerium     oleander, in patients with Stage IV metastatic pancreatic cancer. All patients will receive     PBI-05204.   "
73042|NCT02329704|"     This study evaluates the quality of sperm produced after semen processing using Density     Gradient (DG) and swimming down (SD).   "
73047|NCT02329639|"     Metastatic Breast cancer (MBC) patients from ten Italian Divisions of Medical Oncology, with     histologically confirmed HER2-negative MBC, treated with a first-line therapy including     bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v.     on days 1,8 and 15, every 4 weeks, will be enrolled for the present pharmacogenetic study.     MBC patients treated with first-line chemotherapy including paclitaxel without bevacizumab     will be also enrolled as control group.   "
73048|NCT02329626|"     The main objective of this study is to make a first evaluation of the relationship between     metabolic abnormalities objectified by Positron emission tomography with     2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH)     performed at rest at the onset of symptoms in patients with a first episode of motor     conversion disorder and the persistence of a motor disability at 6 months measured by the     modified Rankin score (mRS).   "
73052|NCT02329574|"     Chronic pain is devastating both to individuals and society. In an aging population, surgery     is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging     from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third     of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly     determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that     individual person-specific factors may play a more important role. In fact, recent studies     indicate that individual differences in pain sensitivity (psychophysics) are more closely     associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed     that women who developed PPMP had lower pressure pain thresholds and greater temporal     summation of pain stimuli than women who did not develop this chronic pain condition.     Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization     were more prominent in women with PPMP. These preliminary, retrospective studies suggest that     individual psychophysical and psychosocial characteristics could be important risk factors     for PPMP. Accordingly, the aim of this study is to comprehensively and prospectively study     women having mastectomy surgery, to determine the relationship between pre-operative     psychophysical and psychosocial factors and the development of PPMP. Using these data, a     prediction model for PPMP will be developed, thus allowing a preoperative calculation of a     PPMP risk score for any patient facing mastectomy.   "
73053|NCT02329561|"     This study evaluates the pharmacokinetics and pharmacodynamics of the enantiomers of tramadol     and O-desmethyltramadol (ODM) in generally healthy young and elderly adults. Using a     randomised, double-blind, crossover design, participants were administered a single 200mg     tramadol extended-release tablet and placebo.   "
73054|NCT02329548|"     This study uses an Alizarin Red powder mixture to characterize the sweat distributions in     youth during tilt table testing. Patients with a known orthostatic sweat response from a     prior clinical tilt table test in the investigators laboratory will be recruited. The     Alizarin Red powder will be applied to exposed skin, and quantitative sweat will be measured     at the thigh. During tilt testing, serial photos will be taken once the sweat response     occurs. Sweat distributions will be compared during syncope (orthostatic sweat), during     periods of anxiety (emotional sweat), and in patients with POTS (with and without syncope).   "
73055|NCT02329535|"     Twin pregnancies are more likely to be delivered preterm than singleton pregnancies. Vaginal     progesterone administration (200 mg Utrogestan) to asymptomatic women with a singleton     pregnancy and sonographic short cervix reduced the risk of preterm birth (PTB) and neonatal     morbidity and mortality, yet not proved efficient in twins' pregnancy. The investigators'     hypothesis is that a higher dose of vaginal micronized progesterone will be more effective in     preventing PTD. The objectives of the study is to compare the rate of preterm birth and     perinatal morbidity and mortality in a twin pregnancy with short cervical length treated with     vaginal 400 mg of micronized progesterone to no treatment. The study is Randomized, open     label, of twin pregnancy between 16-26 weeks of gestation with cervical length under 25 mm.     Women will be randomly assigned to either treatment or no treatment group. Progesterone     treatment will be given until 36 weeks of gestation. Other management will be according to     standard protocol.   "
73056|NCT02329522|"     Objective      The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for     measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this     study are:        1. To investigate whether there is any correlation between haemodynamic parameters and COPD          severity.        2. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic          indicators of 6-month, 1-year, 3-year and 5-year readmission.        3. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic          indicators of 6-month, 1-year, 3-year and 5-year all-cause mortality.      Design, Setting and Subjects This prospective observational study will be conducted in the     Prince of Wales Hospital in Hong Kong.      Interventions Haemodynamic measurements made using the USCOM, and spirometry, will be     performed as appropriate on subjects in respiratory clinic, the emergency department, medical     wards and on ICU. In order to assess inter-observer variability, a second, blinded operator     will repeated 15% of scans.   "
73057|NCT02329509|"     The purpose of this study is to evaluate which surgical protocol for treating Unilateral     Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure)     will have less impact in mid facial growth.      The study hypothesis states that a two stage cleft palate repair , with a late hard palate     repair will reduce maxillary growth impairment.   "
73058|NCT02329496|"     To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation     Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients     with severe calcific aortic stenosis who are considered high risk for surgical valve     replacement.   "
73059|NCT02329483|"     This study aims to predefine the threshold FSH doses during the early follicular phases in     low- dose step-up ovulation induction cycles used to treat anticipated high responders by     monitoring total testosterone and androstenedione blood levels. The blood levels of total     testosterone and androstenedione levels will be measured in patients at the starting day and     at every control day when vaginal sonographic folliculometries and blood estradiol     measurements are made. Hence, we are aiming to define an early monitoring parameter by which     we will be able to define a follicular response to treatment before estradiol rise or     apparently selected follicular growth.   "
73060|NCT02329470|"     A randomized, controlled study in parallel design recruiting 100 patients, 50 in each group.     The patients have had CPAP (Continuous Positive Airway Pressure) treatment between 2 months     to 2 years. The patients are investigated, then half of them (50 patients) are randomized to     withdrawal of CPAP treatment during 3-5 nights followed by second investigation. 50 patients     (control group) continue with CPAP but are investigated similarly than CPAP withdrawal group     after 3-5 nights. The aim of the study is to investigate the effects of obstructive sleep     apnea to arterial stiffness (primary outcome) and whether there is increase in insulin     resistance, cathecol amines, if systemic inflammation occurs after short-term CPAP     withdrawal, and what is the impact of age, gender and oxygen saturation on arterial stiffness     (secondary outcomes).   "
74849|NCT02306044|"     The purpose of the study is to investigate whether platelet indices from automated     haematology equipment, whole blood impedance aggregometry and a standardized bleeding     questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.   "
73061|NCT02329457|"     Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with     malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically     manifested as herpes zoster (HZ), is a major complication that affects up to 50% of patients.     Most patients will require hospitalization. Despite treatment with high dose acyclovir,     patients may develop severe complications including the disabling postherpetic neuralgia,     corneal ulceration, viral dissemination and secondary bacterial infection. The median onset     of infection is the fifth month following transplantation, with 91% of cases occurring within     the first year. Direct vaccination of transplants recipients with subcutaneous     live-attenuated VZVv before transplantation and up to one year after transplantation is     contraindicated. A small prospective non-randomized study has demonstrated that subcutaneous     vaccination for donors before HSCT may offer some protection against VZV reactivation in the     recipients. Recently, dose-sparing influenza vaccine delivered via a novel intradermal     microneedle has been shown to elicit a good immunogenic response in both healthy and elderly     subjects. We sought to assess the efficacy and safety of the novel intradermal     live-attenuated VZVv in sibling donors undergoing HSCT.   "
73062|NCT02329444|"     Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of     contrast media use associated with prolonged hospitalization, cardiovascular events,     persistent kidney damage and increased risk of all-cause mortality. When remote ischemic     preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can     be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised     controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment     and treatment of cardiovascular disease are randomized to receive RIPC or control sham     preconditioning.   "
73063|NCT02329431|"     The goal of this study is to develop an intervention to teach activation skills to Latino     parents who bring children for mental health services.   "
73064|NCT02329418|"     Relatives of patients in situation of withholding and withdrawing life-sustaining therapies     often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when     family members are active in this decision (81%) or when communication is not optimal between     medical team and family members.      There are several ways to assist families of patients in intensive care units [2], amongst     them the use of a written document to explain the environment, therapies and possible     outcomes.      Here the investigators want to test the impact of a written document in the context of     end-of-life conference in intensive care units. Specifically, this research addresses wether     such written support could decrease 3-months post-traumatic stress disorder, anxiety and     depression exhibited by the closest family member or the patient representative.   "
73065|NCT02329405|"     This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat     content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator)     and placebo will be given for a week to volunteers. Hepatic fat content is measured with     magnetic resonance imaging and blood samples are collected at the end of each study arm. The     investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.   "
73066|NCT02329392|"     This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion     pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac     surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with     perioperative serum lactate level is going to be assessed.   "
73067|NCT02329379|"     1. To elucidate the therapeutic role of levothyroxine on the patient with atypia of          undetermined significance (AUS) goiter, we would design a prospective, open label and          non-randomized trial to verify the therapeutic effects on goiter with AUS by means of          TSH (Thyrotropin; Thyroid-Stimulating Hormone) suppression related reduction of goiter          volume with subsequent alleviation of previous cytological malignant tendency. During          following for 1-2 years after therapy with simultaneous monitor of possible adverse          effects of levothyroxine (eltroxin), we collected blood samples and gathered all          necessary data as well as performed thyroid sonography with fine-needle aspiration (FNA)          for the subjects. Furthermore, we would finish our individual study for each enrolled          subject if his/her condition exhibited the criteria of primary end point: reduced goiter          volume under sono >15% or cytology: benign for 2 times; operation for thyroidectomy, CAD          attack, refractory arrhythmia, newly DM (Diabetes Mellitus), etc.        2. To re-evaluate the current prevalence of goiter within Taiwanese adults, we recruited          all patients who presented possible thyroid related symptoms, such as unexplained body          weight loss with increased appetite, palpitation, hand tremors, neck swelling,          hoarseness and abnormal sensation over throat. Only the patients with goiter proven by          thyroid sono in euthyroid status without other preexisting major disorders can be          enrolled in our trial to undergo open label, non-randomized study.   "
73068|NCT02329366|"     This project aims to result in the identification of such markers, and the development of a     feasible quantitative method of distinguishing between tissue that has the capacity to heal     and tissue that does not, thus identifying a non-healing phenotype.   "
73082|NCT02329184|"     The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and     pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending     (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.   "
73069|NCT02329353|"     Periodontitis is one of the most common chronic inflammatory disease with the etiology of     bacterial plaque and is associated with a number of putative bacterial species. The     periodontal destruction is substantially mediated by the host, driven by the bacterial     challenge. The presence of pathogenic bacteria with the absence of so-called beneficial     bacteria and the susceptibility of the host are the main aetiological factors of periodontal     diseases.   "
73070|NCT02329340|"     Injuries are the leading cause of death and disability in children in America. Most injuries     can be prevented when parents implement effective child safety practices. This project will     create a behaviorally based program to teach parents what to do to prevent injuries to their     school aged child, in an effort to reduce the number of injuries, hospitalizations, medical     costs, and missed work days.   "
73071|NCT02329327|"     The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in     patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The     safety of andexanet will also be studied.   "
73072|NCT02329314|"     Collect the details about hepatic dysfunctional patients induced by various etiology who have     a usage of Glycyrrhizic Acid, then arrange and analyse the data to evaluate the clinical     curative effect of glycyrrhizic acid.   "
73074|NCT02329288|"     NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion     of the short ciliary arteries that supply it.      Intravenous injection of glucocorticoid have proven to be effective in treatment of     Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators     believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the     progression of the visual acuity and visual field loss if our hypothesis is correct, would     greatly improve their chances of avoiding blindness.   "
73075|NCT02329275|"     Azoospermia is found in 5-20% of all men suffering from infertility, and in more than 20%     azoospermia remains unexplained. The investigators suggest, that HPV may be an etiological     factor in azoospermia and reduced sperm production.      The investigators plan to examine the occurrence of HPV in testicular tissue from 100     azoospermic men and to compare with the HPV occurrence in testicular tissue from a control     group of 40 normal, healthy men undergoing vasectomy. Since HPV, in a recent Danish study,     was detected on sperm in 16% of 188 randomly selected semen donors, the investigators also     plan to examine the occurrence of HPV on sperm ejaculated during the last week before     vasectomy. If HPV should be found in testicular tissue from men belonging to the control     group, it will be highly relevant to compare with the HPV occurrence on sperm ejaculated from     the men in concern.      A Linear Array HPV Genotyping Kit from Roche will be used for detection of HPV in testicular     tissue and ejaculates. In total, with this test kit 37 HPV genotypes are examined for,     including 13 high risk types.   "
73076|NCT02329262|"     This approach will train peer mentors to deliver a culturally appropriate intervention and     provide social support that is critical for facilitating and sustaining health behavior     change. The objective is to compare the efficacy of an innovative healthy lifestyle skills     mentoring program (Mentored Planning to be Active [MBA]) to a teacher led program (PBA) for     increasing physical activity in Appalachian high school teens. MBA emphasizes the social     determinants of health by using a social networking approach that trains peer mentors to     support targeted teens   "
73077|NCT02329249|"     There is an important need for effective smoking cessation programs that both (a) promote the     effective use of pharmacological aids, such as nicotine replacement products and bupropion,     and (b) provide cognitive-behavioral support for stopping smoking.The Internet is an     increasingly attractive intervention medium for delivering behavior change interventions,     including smoking cessation.This study examined smoking cessation rates among adults     participating in a randomized controlled trial of the Smokefree Partners: 21 Days to Freedom     ™ program, a theoretically based, online smoking cessation program that included message     tailoring and interactivity combined with the live personal support of a smoking cessation     coach. Coaching support was provided almost entirely asynchronously via prescripted but     individually tailored emails.   "
73078|NCT02329236|"     The aim of the our study is to investigate whether there is an increased incidence of ADHD (     based on self reports and questionnaires) among children with short stature due to     constitutional growth delay (CGD) in comparison with children with Familial short stature.   "
73079|NCT02329223|"     This was a Phase III, multicenter, randomized, double-blind, placebo-controlled,     parallel-group study to evaluate the efficacy and safety of omalizumab administered     subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12     - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who     remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.   "
73080|NCT02329210|"     Bardet-Biedl Syndrome (BBS) is a rare genetic disorder associated with a vast array of     symptoms. The features of BBS are highly variable, even between siblings, making long-term     follow-up and centralization of information vital to better understanding this complex     disease and designing effective treatments.      Marshfield Clinic has developed the Clinical Registry Investigating Bardet-Biedl Syndrome     (CRIBBS) to gather comprehensive health information from patients diagnosed with BBS in a     single repository. This information will be used to inform patients, families, and physicians     about the complex features of BBS and will serve as a platform for researchers to develop     effective and targeted treatment strategies for patients with BBS.      CRIBBS is a web-based, confidential database and the privacy of patients enrolled in the     registry will always be respected. Information maintained in the database will be     identifiable only by an assigned study identification number, not by name. The registry     strictly complies with HIPAA regulations. CRIBBS participants may be contacted periodically     with information regarding clinical trials or research studies, but participation is entirely     voluntary.      CRIBBS will bring together complex genetic and clinical information from BBS patients to     accelerate research into effective treatments, attract additional researchers, and make it     easier for researchers to identify patients and find funding for innovative studies.   "
73081|NCT02329197|"     Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At     the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins     diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer     catheter 10 minutes before embryo transfer procedure.   "
73254|NCT02326922|"     Research hypothesis: Release of levonorgestrel from Metraplant-E levonorgestrel releasing     intrauterine contraceptive device is inadequate to be used as a medical line of treatment of     dysfunctional uterine bleeding.      The investigators aim to evaluate the therapeutic effect of the intrauterine system     (Metraplant-E) in the treatment of dysfunctional uterine bleeding.   "
73083|NCT02329171|"     Rationale:      Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer.     High grade CIN (CIN 2-3) is currently treated by large loop excision of the transformation     zone (LLETZ). This treatment has potential complications, such as hemorrhage, infection and     preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed.     Imiquimod (an immunomodulator) was proven effective in the treatment of HPV-related vulvar     intraepithelial neoplasia (VIN) and may also be effective in HPV-related CIN. [van Seters,     2012] However, the evidence is limited and study results are not consistent. [Grimm, 2012;     Pachman, 2012; Lin, 2012]      Objectives:      Primary objectives: (1) to investigate the efficacy of imiquimod 5% cream for the treatment     of CIN2-3 lesions and (2) to develop biomarker panels to predict clinical response to     imiquimod therapy.      Secondary objectives: to assess side effects of imiquimod treatment and LLETZ, disease     recurrence and quality of life.      Hypothesis:      The investigators hypothesize that imiquimod will be an effective treatment modality in     approximately 50-75% of CIN lesions treated without surgical intervention.      Study design:      Single-centre randomized controlled intervention trial.      Study population:      140 women with a histological diagnosis of CIN2-3, equally divided over two study arms.      Intervention:      Patients will be randomized into one of two arms:        1. Imiquimod treatment arm. Patients in this group are treated by a 16-week regime of          imiquimod 5% cream.        2. Standard treatment arm. LLETZ will be performed on patients in this group.      Colposcopy with diagnostic biopsies will be performed after 10 weeks for the imiquimod     treatment arm. In case progressive disease, the treatment will be ended and appropriate     surgical excision will be performed. Treatment efficacy will be evaluated after 20 weeks, by     colposcopy with diagnostic biopsies. A histological biomarker panel will be developed,     consisting of markers representing both host and viral factors.      Main study parameters/endpoints:      The primary endpoint of the study is regression-or-not of CIN2-3, defined as CIN1 or less at     the colposcopy at 20 weeks for the imiquimod arm and PAP 1 cytology at 6 months for the LLETZ     group.   "
73084|NCT02329158|"     The purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches     (HES) for patients undergoing cardiac surgery was safe and effective.   "
73085|NCT02329145|"     Chronic heart failure is becoming more and more common disease and activation of sympathetic     nervous system plays a crucial role in its development. There is some data allowing to     suspect that one of the new treatment methods- renal denervation, also in patients with     chronic heart failure may lead to decrease of systemic activity sympathetic nervous system     and, as a consequence, to decrease of disease progression. The research hypothesis is whether     renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is     used (including resynchronization therapy), is contributing to the improvement in parameters     of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study     is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far     only very limited data- mostly case reports- are available in this study area.   "
73086|NCT02329132|"     Recent reports suggest that anti-VEGF agents (ranibizumab) may suppress the progression of     retinal nonperfusion area. This protective effect would cause the increase of the oxygen     consumption in the diabetic retina. We expect that the current study using the retinal     oximetry would show the protective effects of ranibizumab on the hypoxia in the diabetic     retina. This study is designed to analyze the effects of ranibizumab (Lucentis) to the     retinal oxygen saturation or consumption in eyes with diabetic macular edema.   "
73087|NCT02329119|"     Schizophrenia is considered as the most frequent and the most severe chronic psychotic     disorder. Its evolutionary modes and its clinical symptomatology remain particularly     heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from     being clearly understood. Current empirical studies provide a mean duration comprised between     1 and 3 years without any specific diagnosis or treatment. These diagnosis issues are partly     based on difficulties in the early distinction between schizophrenia and bipolar affective     disorders (BD).      These results emphasize the necessity of new early indices (or endophenotypes). Such markers     are intended to be more specific than classical clinical manifestations. In other words, they     have to be absent among patients with differential diagnosis, such as BD. Among other     possible early indices, several electrophysiological disturbances have been explored.      Our study is designed to mainly describe the N400 component among patients with schizophrenia     or BD. This component is classically interpreted as indexing the integration the meaning of a     linguistic stimulus in its preceding context. Our main hypothesis aims to show a specific     alteration of N400 component among patients with schizophrenia when compared to participants     with BD.      The second aim of this study concerns the exploration of four other event related potentials     (ERPs) among patients with schizophrenia or BD:        -  the P50 component, involved in early sensory gating processes,        -  the P300 component, thought to reflect attentional resource allocation and working          memory updating of stimulus context,        -  the P600 component, elicited during same paradigms than N400, and reflecting their          syntactic congruity.        -  the CNV (Contingent Negative Variation), reflecting processes of motor anticipation      Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400     and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since     the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also     propose to describe the possible relations between these ERPs results and clinical scores     observed among patients.   "
73088|NCT02329106|"     The purpose of this study is to evaluate the safety and efficacy of irreversible     electroportion in unresectable liver cancer close to diaphragmatic dome.   "
73089|NCT02329093|"     As we have previously reported, the primary cause of hip OA with accompanying joint pain     might be bone alterations which can be microfracture. In order to prove it, it is planned     that conservative treatment will be performed on the hip OA patients with accompanying joint     pain for the first year. For the second year, if the patients still have joint pain, they     will do non-weght bearing walk.   "
73090|NCT02329080|"     This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and     feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed     by R-ICE regimen, and by high-dose chemotherapy supported by ASCT.   "
73091|NCT02329067|"     The objectives of the proposed study are to assess whether the metabolic effects of walnut     consumption depends on which food components the walnuts substitute (i.e. carbohydrates;     saturated fatty acids) and whether it is important to consume walnuts as snacks or with     meals.   "
73100|NCT02328950|"     A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full     intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation     (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects     and safety of FA as the backbone of a conditioning regiment for the treatment of patients     with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.   "
73101|NCT02328937|"     This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel     contact lenses comparing central corneal swelling.   "
73219|NCT02327377|"     Functional abdominal pain (FAP), a pediatric pain condition without significant organic     pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood.     This project aims to identify child and family characteristics that predict differential     responses to a Cognitive Behavior Therapy intervention administered online to patients with     FAP and their parents. The goal is to acquire scientific knowledge to guide individualized     treatment of patients with FAP.   "
73092|NCT02329054|"     There is no specific treatment for Ebola Virus Disease (EVD). Current EVD care are     supportive, and includes intravenous or oral rehydration, nutrition, pain killers, treatment     of coinfections with antibacterial and antimalarial drugs, and blood transfusion when     appropriate. Despite these interventions, mortality remains high since the ongoing Ebola     outbreak in West Africa was declared in April.      Potential anti-Ebola specific interventions include convalescent plasma, monoclonal and     polyclonal antibodies, small inhibitory RNA (siRNA), synthetic adenosine analogues or RNA     polymerase inhibitors. All these interventions are considered investigational due to lack of     data in humans with EVD.      In this study, the investigators chose to study the efficacy of favipiravir because this     drug:        -  showed anti-Ebola efficacy in immunodeficient murine models;        -  has been studied in thousands of adult humans participating in anti-influenza trials,          with good tolerance; it has been approved for treating novel or resistant influenza          infections in Japan;        -  is immediately available;        -  can be used orally, and can be easily given in both adults and children because pills          can be crushed and mixed in food or liquids;        -  has recently been used in Europe for treating several patients with EVD; the French drug          safety agency (ANSM) has reviewed published data as well as data provided by the firm          (Toyama Chemical Co., Ltd), and approved its compassionate use in EVD.      Here the investigators propose to assess the efficacy of high-dosed favipiravir in reducing     mortality in humans with EVD.      In the present trial JIKI (means Hope in Kissi language), investigators, sponsor,     scientific advisory board and safety monitoring board will be coordinated in a very reactive     way, so that any new fact can be discussed rapidly and the research plan can be adapted     accordingly (change in drug dosage; use of drug combination; combination with another     strategy such as passive immunization with convalescent plasma, etc.).   "
73094|NCT02329028|"     The EEG is widely used in the diagnosis of central nervous system pathology, including     epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most     hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall     possibility outside these hours. Standard EEG devices are large and their operation require     meticulous application of several leads. The department of clinical neurophysiology at     Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency     department as well as in the prehospital setting. The aims of this pilot study is to evaluate     the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level     of consciousness, as evaluated by the emergency medical provider on the scene, are included.     The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG     is otherwise obtained in a normal fashion, but only three electrodes are used. The sample     size is 30. Data are collected as a part of the clinical work in daily practice. The aim is     to collect observational data on feasibility, no clinical interventions will be performed     based on the EEG. No funding is needed as data is collected during daily work.      The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central     Hospital, and as such, does not have a trade name. It is to be connected to a     monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by     Physio-Control, Redmond, WA 98052. (www.physio-control.com)   "
73095|NCT02329015|"     The purpose of this study is to compare the academic and psycho-social benefits of a     yoga-informed health and wellness program (HWP) to a standard physical education program for     middle and high school students within New York City (NYC) schools.   "
73096|NCT02329002|"     Rationale: Hereditary retinoblastoma survivors have an increased risk to develop second     primary tumors (SPT) at a later age (with the highest risk in their teens), especially when     they have been irradiated for retinoblastoma. The investigators hypothesize that regular     screening with magnetic resonance imaging (MRI) could lead to early detection of SPTs leading     to improved survival.      Objective: To evaluate the potential benefit of craniofacial MRI screening for early     detection subclinical secondary cancers in patients previously irradiated for hereditary     retinoblastoma.      Study design: Prospective multicenter non-invasive screening study. The total study duration     will be four years of screening plus five years of follow-up.      Study population: Irradiated hereditary retinoblastoma patients 8-18 years old Main study     parameters/endpoints: To evaluate the ability of craniofacial MRI for early detection of     SPTs, the investigators will determine the sensitivity and specificity of MRI at detecting     SPTs in irradiated hereditary retinoblastoma patients.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Included patients will undergo yearly craniofacial MRI for a period of 4 years.     They will also be asked to fill out a psychological burden assessment form each visit. A     potential risk of screening might be associated anticipatory anxiety, but screening also     could be reassuring for patients and their parents; the investigators are not sure which will     outweigh. False-positive results from MRI screening could lead to unnecessary further     diagnostics leading to possible added anxiety and diagnostics (e.g., biopsies). However, this     group of patients have a high risk of developing SPTs, with poor 5-year survival statistics.     Early detection and therefore treatment of earlier stage (smaller) tumors, might therefore     increase survival of this patient group.   "
73097|NCT02328989|"     For 25 years, the twin pregnancy rate has regularly increased in the majority of European     countries and in the United States, by 35% between 1981 and 2006. Increased use of medically     assisted procreation and older maternal age are the two main causes. At the present time twin     pregnancies represent nearly 20% of premature deliveries. The rate of very premature births     (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As     prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is     the principal cause of neonatal mortality and of brain sequelae in twins, the search for a     preventive treatment appears as a priority in perinatal medicine. The investigators recently     showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a     better predictive investigation of premature delivery < 34 wks than digital examination.     Recently in a randomized trial in a population of short-cervix singleton pregnancies, the     premature delivery rate decreased by 40% in the pessary group compared with the usual     management group. No other trial of pessary use in short-cervix twin pregnancies was     published today. Recently, in a historical comparison of twins with twin-to-twin transfusion     syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery     with the use of pessary in case of short cervix. The investigators wish to set up a     randomized multicenter study in France in the population of short-cervix twin pregnancies to     show a potential benefit of the pessary compared with simple surveillance.   "
73098|NCT02328976|"     The purpose is to compare, using functional magnetic resonance imagery in resting-state, the     connectivity of the hypothalamus in 2 groups of migraineurs. The first group is composed of     chronic migraineurs, studied outside a migraine attack and is compared to gender- and age-     matched episodic migraineurs with very few attacks per month and studied in the attack-free     period. The primary outcome will be the connectivity index of the hypothalamus to brainstem     areas activated during migraine attacks and to the trigeminal-cervical complex.   "
73099|NCT02328963|"     Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after     transplantation. It is associated with an increased incidence of acute rejection and lower     graft and patient survivals. The goal of this study is to demonstrate that an     immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can     prevent acute rejection episodes as efficiently as standard regimen but also efficiently     reduce the incidence of CMV infection at 6 months post-transplantation.   "
73102|NCT02328924|"     This study, prospective randomized controlled trial, tried to identify a cut off value of     luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible     gonadotropin-releasing hormone antagonist protocols.      202 norma-ovulatory women < 39 years were randomized to fixed or flexible group in GnRH     antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and     progesterone in the two study groups was measured. Total number of retrieved oocytes,     implantation and pregnancy rate were recorded.   "
73255|NCT02326909|"     The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the     diagnosis of Upper Urinary Tract Urothelial Carcinoma.   "
73106|NCT02328872|"     Compass is a randomised controlled trial of primary HPV testing for cervical cancer screening     in Australia. A pilot study involving 5,000 women was carried out in 2013-2014. The trial     will involve recruiting 121,000 women from primary health clinics. Women aged 25-69,     attending for cervical screening or for routine follow-up will be invited to participate in     the 2-arm trial. A liquid-based cytology (LBC) sample will be taken from consenting women and     sent to VCS Pathology. Women will be randomised in a 1:2 parallel group allocation to LBC and     HPV arms using randomisation with the minimisation procedure, with stratification by birth     cohort according to whether offered HPV vaccination in Australia's national publicly-funded     HPV vaccination program (date of birth >=July 1st 1980 and <1st July 1980). In the LBC     (active control) arm, women will undergo 2.5 yearly image read cytology screening with reflex     HPV triage testing for low grade cytology. In the HPV (intervention) arm women will undergo 5     yearly HPV screening with partial genotyping enabling separate identification of HPV16 and     HPV18 and referral of this group for diagnostic evaluation, and secondary randomisation of     intermediate risk women testing positive for oncogenic HPV (but not HPV 16 or 18) to either     image read LBC screening or dual-stained (DS) cytology testing with p16/Ki67. The laboratory     reports issued to practitioners will specify the recommended management for women, according     to study arm and test results.Participating women will be flagged on the Victorian Cervical     Cytology Registry (VCCR) and clinical outcomes will be tracked via the VCCR. Data linkage     between the VCCR and the National HPV Vaccination Program Register will be performed in order     to integrate vaccination and screening histories for trial participants. Participants will be     followed for an anticipated 5 years from the time of recruitment and the primary outcome is     based on the total cumulative detection of CIN3+ after exit testing at 5 years.   "
73107|NCT02328859|"     A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and     mobility rehabilitation in individuals with transtibial amputation. The system is composed of     a treadmill that can simulate different environmental situations such as walking up stairs     and hills and going around curves. The treadmill is synchronized with an immersive display     and an avatar of the user. The combination of variable terrain and visual feedback is     extremely promising as a means for amputee patients to achieve improved functional mobility     after gait training. The proposed work is relevant to public health because it is the first     step in developing a novel rehabilitation system that will use visual feedback for gait     training in amputees and others with pathological gait disorders. The research is pertinent     to the mission of the Department of Veterans Affairs which is committed to improve the     quality of life of Veterans with disability.   "
73108|NCT02328846|"     Evaluation of the microcirculation is currently limited. Continual assessment of the tissue     carbon dioxide-arterial carbon dioxide (PtC02-aCO2) offers a new, novel and noninvasive     method of determining the state of the microcirculation. The investigators will apply two     non-invasive devices, the Braedius sidesteam darkfield microscopy (SDF) microscopy device to     the sublingual circulation and the transcutaneous PtC02 probe to the forehead in subjects     undergoing cardiac surgery with cardiopulmonary bypass. The PtC02-aCO2 gradient will be     determined and correlated with the videomicroscopic images of the sublingual     microcirculation. Thereafter the incidence of postoperative organ failure and acute kidney     injury will be determined and correlated with PtC02-arterial CO2 gradient and     videomicroscopic images.      Data will be analyzed by standard descriptive statistical methods.   "
73109|NCT02328833|"     The aim of this study is to evaluate the effects of an active multifactor implementation     process of a Computerized Depression Guideline in Primary Care. The CPG-DEPc use use, the key     outcomes and its maintenance over time in patients and professionals will be analyzed.   "
73110|NCT02328820|"     This study evaluates the prognostic value and therapeutic potential of combined pressure and     flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary     flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal     medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be     treated with percutaneous coronary intervention (PCI).   "
73111|NCT02328807|"     The main purpose of this study is to evaluate the safety and efficacy of focal (targeted)     Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized     prostate cancer.   "
73112|NCT02328794|"     Using the NIH-funded Way to Health platform, the investigators will conduct this smoking     cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to     determine the effectiveness of 4 different interventions aimed at smoking cessation, two of     which are incentive structures that are each grounded in behavioral economic principles. The     other interventions will determine the effectiveness of various cessation aids, including     electronic cigarettes and text messaging, on smoking cessation. This study will be conducted     as an opt-out procedure where participants are automatically enrolled in the program but have     the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate     the effects of such programs in an employee based population that can be easily mimicked in     other employee based populations.   "
73113|NCT02328781|"     The purpose of this study is to evaluate the safety and efficacy of Firehorus vertebral     artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in     treatment of symptomatic vertebral artery stenosis.   "
73114|NCT02328768|"     The overall purpose of this study is to determine if replacing standard soybean oil based fat     emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the     progression of parenteral nutrition associated liver disease. It is a compassionate use     protocol for patients who already have significant liver disease related to parenteral     nutrition.   "
73115|NCT02328755|"     This protocol is an open label, single arm, non-randomized, phase I / II clinical trial     investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for     prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of     allogeneic hematopoietic stem cell transplantation (HCT).   "
73116|NCT02328742|"     The main objective of this study is to describe the level of expression of the biological     factors involved in the formation of adhesions (Transforming growth factor beta, Activin A,     inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another     intracavitary disease or no intracavitary disease.   "
73144|NCT02328378|"     The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage     of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local     anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread     of the local anesthetic agents produces extensive analgesia and prolonged action of the     injected local anesthetic solution.      Previous studies showed that TAP block may not be effective in improving postoperative     analgesia in patients who had cesarean section under spinal anaesthesia.      The aim of this randomised controlled, double blinded study is to examine the effect of QLB     on the postoperative pain management in patients who had cesarean section under spinal     anesthesia.   "
73117|NCT02328729|"     Incident and extent of pulse alteration during administration of various modes of local     anesthesia in children during routine dental treatment. Our aims are: (1) To estimate the     percent of patients who receive mandibular block , C-CLAD-IL or infiltration injections and     show increase in their pulse rate during the delivery of anesthesia (in spite of negative     aspiration) as result of infiltration of adrenalin into their blood vessels. (2) To estimate     the extent of pulse rate alteration in correlation with the velocity or volume of local     anesthesia injected. (3) To examine the correlation between increase in the pulse rate and     effectiveness of anesthesia. (4) To examine the correlation between the needle gauge (27 &     30) and increase in pulse rate during mandibular block injection in spite of negative     aspiration. We will recruit children that undergo routine dental treatment under local     anesthesia (such as mandibular block, infiltration or C-CLAD-IL). Patients will be connected,     immediately before and during the entire delivery of the local anesthetic, to pulse-oximeter     that will be connected to a computer and continuously monitor pulse rate and saturation     during the delivery of local anesthesia. Each aberrant event which may occur during     alteration of the pulse rate such as gag reflex, coughing, or pain related disruptive     behavior will be documented on the computer in real time by another person that is not the     treating dentist. All types of local anesthesia delivery will be performed by the     computerized-controlled local anesthesia delivery system - Single-Tooth-Anesthesia which     connected to a computer and documents continuously the amount and velocity of the local     anesthetic delivered to the patient. All injections will be performed by using a 29 gauge     needle, except when children will be treated under general anesthesia, the injection will be     performed also by 27 gauge needle. In case the pulse rate will increase to 150% of the     baseline rate, or when the pulse will reach 150 beats/minute the injection will be stopped     immediately. The continuation of the local anesthetic delivery will be continued in different     location and only after the return of the pulse to its basic rate. A total of 100 patients     will receive local anesthetic containing 1:100,000 adrenalin and 50 patients without     adrenaline. Three modes of local anesthesia will be evaluated: C-CLAD-IL, infiltration and     mandibular block= a total of 300 patients.   "
73118|NCT02328716|"     The purpose of this clinical trial is to Investigate whether the administration of HIPEC with     Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in     women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival     period compared with patients without HIPEC treatment.   "
73119|NCT02328703|"     This is a prospective, randomized, double-blind, placebo-controlled, repeated measures study     with intention-to-treat that involves exposure to Reiki therapy or a placebo control     intervention for a total of six treatments, three treatments per week for two weeks, with a     2-week follow-up for the decrease of neuropathic pain in extremity trauma.   "
73120|NCT02328690|"     The purpose of this prospective, double-blind, repeated measures study is to assess the     efficacy of Binaural Beat Technology (BBT) on anxiety and anxiety related cardiovascular     measures as well as to assess the feasibility of implementing a BBT intervention in a     military population during the high risk post-deployment window.   "
73121|NCT02328677|"     ColoCare is an international prospective cohort study of stage I-IV colorectal cancer     patients (ICD-10 C18-C20).   "
73122|NCT02328664|"     After endoscopic removal of a colorectal polyp that harbors (unexpected) adenocarcinoma,     pathology usually can not guarantee a radical resection from an oncological point of view. In     such case, additional surgical resection is advised. However, only in 15% of patients,     residual adenocarcinoma is found. This study investigates the sensitivity of biopsies from     the polypectomy scar for residual adenocarcinoma.   "
73123|NCT02328651|"     This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer     Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth     disease compared with the controlgroup that recieve only libavirin treatment.   "
73124|NCT02328638|"     The purpose of the proposed study is to develop and pilot test a manual-based,     interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder     (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and     Expanding variety (CHANGE) obesity program.   "
73125|NCT02328625|"     This registry study will assess the safety and performance of the Celution Device in the     processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in     the treatment of hand scleroderma.   "
73126|NCT02328612|"     Phase I, randomized, parallel group, placebo control, unicentric, interventional study.     Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs     or placebo group if they meet all the inclusion criteria at a 3:1 ratio.      The treatment administration will be infused intravenously to the following groups after     randomization:        -  First arm: 250,000 cells/kg        -  Second arm: 1 million cells/kg        -  Third arm: 4 million cells/kg        -  Fourth arm: placebo according to their weight.      An hour after the end of the eASCs administration, all subjects will be given an intravenous     dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable     by the investigator.   "
73127|NCT02328599|"     Previously, 4 investigators conducted randomized controlled trials (RCT) at their own site to     evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of     type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years.      The aim of this study is to combine data from the 4 studies and continue to follow the     original randomized subjects for an additional 2 years of follow-up. The purpose of the study     is to determine the longer term durability and effectiveness of bariatric surgery compared to     medical/lifestyle intervention on the treatment of type 2 diabetes.   "
73128|NCT02328586|"     This research project will test the feasibility and effectiveness of group acupuncture for     the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or     osteoarthritis).   "
73129|NCT02328573|"     The study will focus on the impact of communal singing on patients with stroke and their     personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the     first group of 20 stroke survivors and their caregivers (up to 40 total participants) will     receive 6 months (approximately 24 sessions) of music therapy. The second control groups of     20 stroke survivors and their caregivers will receive standard post-stroke care   "
73160|NCT02328170|"     The purpose of this study is to determine the correlation of specific IgE levels to common     foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap   "
74990|NCT02304211|"     The purpose of this protocol is to demonstrate that intra-arterial administration of a drug     can generate information in a manner that faithfully mimics effects of systemic     administration but with little or no systemic effects.   "
73145|NCT02328365|"     More than one third of patients with colorectal cancer (CRC) suffer from comorbidity such as     heart and lung diseases. This comorbidity markedly impairs survival after surgical treatment     owing to increased mortality within the first weeks to months after surgery. Since the     operation itself constitutes a severe challenge to the patient's cardiopulmonary system, this     study aims to elucidate whether a more systematic perioperative management and follow-up of     colorectal cancer patients with cardiopulmonary comorbidity may improve their outcome as     measured by complications, hospitalisation times, and survival.   "
73146|NCT02328352|"     Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new     fixing method for prosthetic materials in the treatment of abdominal wall hernias in humans,     in laparotomic procedures and as a new device for the treatment of solid cancer and     hematopoietic system tumors.      The experimentation on this new material, preliminary conducted on breed female rabbit New     Zeeland, will be applicable to human, if the results in terms of toxicity and durability will     be comfortable.   "
73130|NCT02328560|"     The project aims primarily to measure the expected paramedic consultation announcement     benefits for the patient, at different levels. It will measure improvements in the management     of patients treated with chemotherapy. Indeed, paramedical consultation ad aims to provide a     better understanding of the disease and treatment incurred, which should lead to the     implementation of joint strategies between the healthcare team and the patient to prevent the     effects of and treatment of the disease by the patient and caregivers.      This improvement is to promote the fair treatment by reducing patient anxiety and / or carers     and involving them in the management of their disease. In this context, it is shown a profit     of paramedical consultation for the patient, it will work, based on the recommendations of     the Cancer Plan, strengthen the need to routinely offer paramedic Ad consultation.      This work should also help measure the impact of ad paramedical consultation on optimizing     care consumption off-line therapy and to assess the associated costs.      For patients who received paramedic ad or not consultation, it will therefore be of     particular compare intercurrent hospitalizations, commuting structure of care, the number of     consultations with the doctor, the reports of cure, additional biological monitoring or other     health care consumption.      With the participation of several centers in the fight against cancer, this study will     provide valuable information on the practice of paramedical consultation ad in several tumor     sites.      It will objectify the benefit provided by the Medical device announcement for both patients     and the organization and use of care prerequisite to encourage better integration of this     device in the course of patient care, the consultation paramedical ad remaining poorly     understood by many health professionals.   "
73131|NCT02328547|"     The objectives of this study are (1) to determine the efficacy of fecal microbiota     transplantation (FMT), given as oral capsules, compared with placebo for the treatment of     refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of     FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety,     feasibility, and tolerability of FMT for patients with IBS-D.   "
73132|NCT02328534|"     The investigators evaluate the feedback of using swim down semen processing method during     preparation for ICSI and compare the results of pregnancy and embryos quality with the cases     used density gradient method for their semen processing.   "
73133|NCT02328521|"     The investigators aim to investigate the effect of oral nicorandil on neointima after     coronary drug-eluting stent implantation in patients with diabetic mellitus.   "
73134|NCT02328508|"     This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing,     inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial     wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with     diabetes.   "
73135|NCT02328495|"     The aim of this study is to compare the effectiveness of misoprostol versus uterine     straightening by bladder filling for pain relief in menopausal patients undergoing office     hysteroscopy.   "
73136|NCT02328482|"     This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent     control, parallel group study. Patients completing protocol BBCO-001 will be offered the     opportunity to enter into this 12-month randomized withdrawal protocol.   "
73137|NCT02328469|"     The main objective of this study is:        -  to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia        -  to assess the clinical course and outcome of tick-borne encephalitis and Lyme          neuroborreliosis        -  to characterize the inflammatory proteins, gene polymorphisms, and transcriptome          profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis   "
73138|NCT02328456|"     The purpose of the study is to use a randomized controlled design to determine the impact of     a SMS messaging associated with free eye drops intervention on the following outcomes among     patients after trabeculectomy surgery in rural China.   "
73139|NCT02328443|"     Evaluation and validation of metabolic markers for the assessment of CYP3A activity and     prediction of drug-drug interaction in Korean healthy subjects.   "
73140|NCT02328430|"     Comparison of standard spirometry to non invasive remote lung function measures of chest wall     movement using depth camera technology.   "
73141|NCT02328417|"     Prospective non randomized study of two cohorts: usual protocol and the application of     accelerated recovery protocol. F/up after discharge, 90 days and thereafter according to     protocol of each center. Compliance to be assessed.   "
73142|NCT02328404|"     This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial     designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on     Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum     chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian     female patients diagnosed with PCOS and with hypovitaminosis D.   "
73185|NCT02327845|"     The goals of this study are: (1) to better understand the relationship between the phenotype     and genotype of amyotrophic lateral sclerosis (ALS) and related diseases, including primary     lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy     (PMA), and frontotemporal dementia (FTD); and (2) to develop biomarkers that might be useful     in aiding therapy development for this group of disorders.   "
74991|NCT02304198|"     This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial     Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).   "
73143|NCT02328391|"     OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in     second-line treatment in patients with lung cancer advanced non-small of histology     predominantly flaky by assessing the survival free of progression (SLP).      Design Studio postautoritation of multicenter observational follow-up prospective (EPA-SP)     type.      DISEASE OTRASTORNO A study of cell Lung Cancer not small (NSCLC). MEDICATION object data to     study the drug under study is erlotinib.      -Dose and treatment guidelines follow the corresponding product sheet. Management of dosage     and adverse effects specified in point H. 15 of the Protocol.      POPULATION in study and number TOTAL of subjects population under study: adult patients with     diagnosis of NSCLC with predominantly squamous histology total number of subjects: the     participation of approximately 51 patients is expected DISEASE OR DISORDER TO STUDY Non Small     Cell Lung Cancer (NSCLC). MEDICATION DATA OBJECT OF STUDY The drug under study is erlotinib.      -Dose and treatment guidelines Follow the corresponding product sheet. Management of dosage     and adverse effects specified in point H. 15 of the Protocol.      STUDY POPULATION AND NUMBER TOTAL OF SUBJECTS Study: adult patients with diagnosis of NSCLC     with predominantly squamous histology total number of subjects: the participation of     approximately 51 patients is expected.   "
73147|NCT02328339|"     The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar     a placebo matched for taste and appearance in a blinded cross over design.   "
73148|NCT02328326|"     This trial will compare two methods of increasing engagement in care and success in diabetes     management, among patients with diabetes with high-risk features, who also have family     members involved in their care.   "
73151|NCT02328287|"     Failed fusion and failure to relieve back pain following spinal fusion are still frequent,     irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision     surgeries are unfortunately associated with higher procedure-related complication rates,     technical difficulties, longer operative time, and quite disappointing and unreliable success     rates for both fusion and clinical results.      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a     proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.   "
73152|NCT02328274|"     Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its     popularity in the past decade due to its minimal invasiveness that results in less operation     time, less blood loss and quicker return to normal activity. The standard surgical procedure     in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus,     dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed by     amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel,     monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer operative     time and higher possibility of conversion to laparotomy due to technical difficulty and     excessive blood loss. In order to overcome these difficulties, we introduce a modified     surgical technique of LASH which incorporated two methods of vessels ligation and     laparoscopic in situ morcellation.   "
73153|NCT02328261|"     This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with     advanced nasopharyngeal carcinoma.   "
73154|NCT02328248|"     The purpose of this study is to observe the effective and safety in the laparoscopic repair     of hiatal hernia using biological patch versus plastic.   "
73155|NCT02328235|"     Skeletal muscle burns a significant amount of the fat and sugar that circulates in the blood     stream. Ideally, when sugar is elevated in the blood stream, the muscle will either use it to     make new energy or store it for later use. Likewise, for fatty acids. Skeletal muscle of     obese and diabetic humans has been shown to inadequately use either sugar or fatty acids when     they increase in the blood stream, and this has been termed metabolic inflexibility. The     cause of metabolic inflexibility is not known, but it is believed that eating more fat than     the body needs for energy may be a contributing factor. Metabolic inflexibility in skeletal     muscle is bad because if the muscle does not use the sugar or fat, it will be stored     elsewhere in the body and potentially lead to obesity and the resistance to insulin. The     investigators have performed a research study with nonobese, healthy humans during which we     fed them a high fat diet for 5 days. Interesting, only 5 days of a high fat diet is     sufficient to cause the skeletal muscle to become metabolically inflexible just like that     observed in obese and diabetic humans. The investigators are proposing addition studies to     feed healthy humans a high fat diet for 5 days in effort to better understand what causes     metabolic flexibility. The investigators are speculating that a high fat diet causes the     intestines to release a substance called endotoxin that causes muscle to become metabolically     inflexible. The investigators will test this notion in our proposed studies.   "
73156|NCT02328222|"     BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve     long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that     alter graft function or survival. Our objective was to evaluate the effects of early steroid     withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme     consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction     treatment with basiliximab.      METHODS: A randomized clinical trial was performed on first renal transplant recipients. In     the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth     day post-transplantation. In the Control group, patients continued steroid treatment.   "
73157|NCT02328209|"     Recently studies have shown that intravitreal injection of ranibizumab is effective for age     related macular degeneration. However there are problems about injection regimen of     maintenance phase. We plan to perform new simplified treat and extend regimen using     ranibizumab.   "
73158|NCT02328196|"     The McGill Ingestive Skills Assessment (MISA) for measuring dysphagic clients' functional     performance during meals has been previously translated into Danish (MISA-DK) and this     translated version validated. Critical issues about the construct validity of the scale, per     se, had been raised. Consequently, major revisions of the MISA-DK have been undertaken, which     necessitates a new validation process. Therefore, the purpose of this study is to evaluate     the construct validity of a revised version of the MISA-DK when used amongst dysphagic adults     in hospitals settings and community services.   "
73159|NCT02328183|"     The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram     negative bacterial infection. The hypothesis of study is Polymyxin B would be the new     antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes     and minimal side effects.   "
73161|NCT02328157|"     Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative     corneal astigmatism.      Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival     sutureless vitrectomy, resulting in good visual recovery. So far, however, limited     information is available on the the stability of axis rotation, astigmatism correction, and     improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a     25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the     current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a     triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of     IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal     and refractive astigmatism up to 6 months postoperatively. We are expecting to show that     postoperative IOL axis stability is similar to that reported for cataract surgery alone in     vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.   "
73237|NCT02327143|"     The aim of this study is to compare how much of the study drug gets into the blood stream     when it is given as a single oral dose and as an intravenous infusion (given directly into a     vein via a small needle).      The study will also provide information on how well the study drug is tolerated when given as     a tablet in combination with giving it intravenously, and information on any changes in heart     function.      The study will last about 10 days. Screening is required within 28 days before study drug is     given.   "
73162|NCT02328144|"     Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause     of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a     difficult symptom to appreciate and assess, by its frequent and large variations in     sensitivity in each patient. Many studies have been done to reduce patient postoperative     pain, but there is no ideal method. The application of both oral and topical metronidazole     has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.      The investigators evaluated the effect of oral administration of metronidazole versus     homologated placebo in pain control after hemorrhoidectomy   "
73163|NCT02328131|"     The great diversity of regimens and treatment lines, the different efficacy of these, mostly     due to the increase in bacterial antibiotic resistance and regional differences, requires a     continuous critical analysis of clinical practice, evaluating systematically the efficacy and     safety of the different regimens and the cost-effectiveness of the different     diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized     treatment that will reduce number of re-treatments, diagnostic tests and the appearance of     associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably,     gastric cancers. Therefore, the evaluation of real clinical practice using     non-interventionist registries will help to improve the design and organization of European     Consensus on the management of H. pylori infection, which is the best way to establish     healthcare efficiency.      Primary aim      To obtain a database registering systematically over a year a large and representative sample     of routine clinical practice of European gastroenterologists in order to produce descriptive     studies of the management of H. pylori infection.      Secondary aims        1. To evaluate H. pylori infection consensus and clinical guidelines implementation in          different countries.        2. To perform studies focused on epidemiology, efficacy and safety of the commonly used          treatments to eradicate H. pylori.        3. To evaluate accessibility to healthcare technologies and drugs used in the management of          H. pylori infection.        4. To allow the development of partial and specific analysis by the participating          researchers after approval by the Registry's Scientific Committee      Methodology Non-interventionist prospective multicentre international registry promoted by     the European Helicobacter Study Group. A renowned gastroenterologist from each country was     selected as Local Coordinator (30 countries). They will in turn select up to ten     gastroenterologists per country that will register the routine clinical practice     consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables     retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome     data. The database will allow researchers to perform specific subanalysis after approval by     the Scientific Committee of the study.   "
73164|NCT02328118|"     Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic     patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth     factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.   "
73165|NCT02328105|"     ABRAXANE, based on results from prior studies, is a promising drug in squamous cell carcinoma     of the lung. This study will help to explore the combination of ABRAXANE and carboplatin more     thoroughly in the subgroup of patients who had the best response in prior studies as well as     determine whether there are any biomarkers which can predict for response.   "
73166|NCT02328092|"     The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation     for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to     receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a     total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting     treatment, immediately after the 5th and 10th treatment session, and 1 month later, using     frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical     excitability of upper and lower limbs were done before and after the end of sessions.   "
73167|NCT02328079|"     The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in     complete recovery of facial Palsy. Fifty patients (Males and females) with acute Facial Palsy     within the first 3 days of onset with age ranged from 15-60 years old. Each patient submitted     to the following clinical evaluation using House and Brackmann6 facial function scoring     system and Synnybrook grading system neurophysiological assessment of facial nerve and     muscles before and after the end of treatment and then after the end of first and second     month of treatment. EMG will be done for facial muscles of both sides beside measuring facial     nerve excitability to determine the excitation threshold by recording the minimum electrical     stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA     between the affected and unaffected side is considered to be significant in terms of poor     prognosis. Nerve conduction study of facial nerves of both sides using concentric needle     electrode. Trigeminal Blink reflex for both side of the face. Facial functional recovery was     defined as good or complete using the same criteria used in the 2001 practice guideline.     Using the House and Brackmann6 facial function scoring system, we considered an outcome of     grade I or II a good recovery.   "
73168|NCT02328066|"     The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to     predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold     standard, in a group of endoscopists who previously performed a training program.   "
73169|NCT02328053|"     The study is a randomised control trial to assess the visual and clinical outcomes of     collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal     blindness in India and the therapeutic options available are minimal to handle the advanced     complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role     of corneal cross linking was demonstrated by several studies earlier,we anted to specifically     assess the role of corneal cross linking in non resolving fungal keratitis in prevention of     perforation and enhancement of healing process.   "
73170|NCT02328040|"     There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (Type 1 DM),     however after a meal sugars are always a concern. There is a drug sitagliptin (Januvia) which     is FDA approved to treat people with type 2 diabetes which helps correct their glucose     (sugars) after meals. This study is going to test whether this drug can improve the after     meal sugars in people with type 1 diabetes. To test this, you will be given a mixed meal and     its effects on insulin levels. The hormones that affect blood glucose as well as your sugar     levels will be measured by a series of blood tests. We will also look for high blood sugars     which might occur because of food staying longer in the stomach than usual or due to the     suppression of a hormone called glucagon which increases blood sugar. If you qualify, you     will be given sitagliptin (Januvia) 50 mg and 100 mg dosages. You and the researchers will     not know which dose you are taking at any single visit. We will first enroll 10 subjects with     established type 1 Diabetes Mellitus for at least 1 year, between the ages of 18-30 years     old. The first 10 patients will be evaluated for safety parameters such as ability to keep     blood sugars < 70 mg/dl for at least 70% of the time, no episode of severe hypoglycemia (low     blood sugars) and so on. After this safety criteria is established, we will then recruit     subjects between the ages of 14-19 yrs for the next phase of the study. A total of 17     subjects will be enrolled into the study.   "
73171|NCT02328027|"     The objectives of the study are:      Primary objective:      - To determine the safety and tolerability of medical imaging with 99mTc-rhAnnexin V-128      Secondary objectives:        -  To determine the biodistribution, pharmacokinetics and radiation dosimetry of          99mTc-rhAnnexin V-128        -  To demonstrate the time-dependant distribution and localization of 99mTc-rhAnnexin V-128          both in RA and AS patients        -  To determine ability of early imaging with 99mTc-rhAnnexin V-128 to evaluate the          presence of lesions before and after short term treatment of either RA or AS patients.      Study hypothesis:      99mTc-rhAnnexin V-128 could be used as an adjunct for the diagnosis of early stage rheumatoid     arthritis and ankylosing spondylitis and for the assessment of response to treatment of these     diseases.   "
73172|NCT02328014|"     This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and     efficacy ACP-196 and ACP 319 in B-cell malignancies.   "
73173|NCT02328001|"     This study performs a single intervention of informing endoscopists how much the disposable     accessories cost following each procedure. Following this single and simple intervention,     prospective analysis of EGD and colonoscopy accessory use and pathology specimen costs will     be compared to the same resource costs during a control period where endoscopists are blinded     to their observation.   "
73174|NCT02327988|"     This study propose investigate the effect of cryotherapy and laser therapy in response to     strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms).     All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions     of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise),     composed of pain sensation, measure of the strength and muscle activation.   "
73175|NCT02327975|"     Physical inactivity is a health problem that affects people worldwide and has been identified     as the fourth largest risk factor for overall mortality (contributing to 6% of deaths     globally). Many researchers have tried to increase physical activity (PA) levels through     traditional methods without much success. Thus, many researchers are turning to mobile     technology as an emerging method for changing health behaviours.The study consists of a     physical activity intervention through a mobile application in elderly. The study is a 3x2     model, in which the sample is distributed in three study groups (over 53 years) and were     evaluated at 10 weeks from baseline.   "
73176|NCT02327962|"     Chronic kidney disease (CKD) accelerates vascular stiffening related to age. Arterial     stiffness may be evaluated measuring the carotid-femoral pulse wave velocity (PWV) or more     simply, as recommend by KDOQI, monitoring pulse pressure (PP). Both correlate to survival and     incidence of cardiovascular disease. PWV can also be estimated on the brachial artery using a     Mobil-O-Graph; a non-operator dependent automatic device. The aim was to analyse whether, in     a dialysis population, PWV obtained by Mobil-O-Graph (MogPWV) is more sensitive for vascular     aging than PP.      A cohort of 143 patients from 4 dialysis units has been followed measuring MogPWV and PP     every 3 to 6 months and compared to a control group of non-CKD patients.   "
73177|NCT02327949|"     The purpose of this study is to determine whether this new W-Shaped Angular Plate is more     effective and more safe to operate than the traditional reconstruction plate in the treatment     of the posterior wall fracture of acetabulum.   "
73178|NCT02327936|"     The purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL     and to compare their efficacy for overactive bladder syndrome in children.   "
73179|NCT02327923|"     Comparison of intraoperative infusion of lidocaine and esmolol in the postoperative     requirement of opioid for postoperative pain management after laparoscopic cholecystectomy to     decrease opioid related side effects and enhance postoperative recovery with multimodal     analgesia approach.   "
73180|NCT02327910|"     Three hundred aged(age>65y) patients were randomized to Commom group(C group). Qualitative     TOF monitoring (TOF group). Qualitative TOF and transcutaneous partial pressure of carbon     dioxide monitoring(Unite group). Anesthetic management was standardized in all subjects .The     patients of C group were extubated when standard criteria were met; T group patients had a     TOF ratio of greater than 0.90 as an additional extubation criterion;and U group patiens were     extubated when TOF ratio is greater than 0.90 and meanwhile transcutaneous partial pressure     of carbon dioxide recovered to preoperative ±5mmHg .All the patients were transport to the     PACU after extubation.Compare the adverse respiratory events at the moment of extubation, on     the arrival of PACU, at 30min and 60min moment in the PACU respectively.   "
73220|NCT02327364|"     The purpose of this 3-year, multi-site, non-randomized, prospective, observational study is     to characterize the natural history of Pearson Syndrome. The Syndrome is a rare mitochondrial     disorder due to a large-scale mtDNA deletion. Children typically present in their 1st two     years of life (most in infancy) with anemia and/or pancreatitis. Most individuals with     Pearson Syndrome die in childhood. Those who survive evolve to Kearns-Sayre Syndrome/Chronic     Progressive External Ophthalmoplegia (KSS/CPEO) although accurate survival estimates are not     yet known.   "
84349|NCT02181959|"     The purpose of this trial was to evaluate the safety and tolerability of a galenic     formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy     volunteers.   "
73181|NCT02327897|"     Background:      - Asthma is a serious clinical and public health problem. Researchers want to collect data to     better understand how bacteria and other things in the environment can affect people's     asthma.      Eligibility:      - Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or     breastfeeding.      Design:        -  Partaicipants will complete a medical history form before the first visit.        -  Study visits will include collecting medical history, and conducting physical exam, lung          and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum          samples.        -  Participants will take tests that measure their breathing abilities. They will give          saliva samples for DNA study. They will get kits to collect stool and dust samples at          home. They will fill out surveys.        -  Participants will have visits every 6 months for 5 years. They can schedule sick visits,          if needed, at no cost to the participant. For all visits, they will have asthma          check-ups and get treatment, at no cost to the participant.        -  Some participants may take part in a sub-study that includes one 4-hour visit. They will          have medical history, physical exam, and lung tests. They will have urine tests to check          for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an          intravenous line will be placed in an arm vein. The nose and throat will be numbed. A          flexible fiber-optic tube will be inserted into their airways through the nose. Their          airways will be examined and areas of their lung will be washed. A small sample of cells          will be taken.   "
73238|NCT02327130|"     Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The     ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value (BDV).     This study is seeking to determine if the breath delta value of critically ill adults is an     early indicator of the onset of infection that may lead to sepsis.   "
73239|NCT02327117|"     Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The     null hypothesis of this study was that TA has no effect on post surgical bleeding in patients     undergoes TKA.   "
73182|NCT02327884|"     Background:      - Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders     can affect a person s quality of life. Studying people who have a disease that affects their     salivary gland(s) may teach researchers about the disorders and their genetics.      Objectives:      - To study salivary gland diseases and disorders. To collect data and samples from people     with salivary gland problems and their relatives.      Eligibility:        -  People more than 4 years old who have or are suspected to have a disease involving          salivary glands.        -  Their relatives more than 4 years old.        -  Healthy volunteers 18 years or older.      Design:        -  Participants may be screened with:        -  Medical history        -  Physical exam        -  Blood and urine tests        -  General oral and dental history and exam        -  Saliva collection        -  Eye exam and test for dry eyes        -  Health questionnaires (adults)        -  Biopsy of some minor salivary glands. A small incision will be made on the inside of the          lower lip and several tiny salivary glands will be removed.        -  Participants will have 2 3 visits. These may include:        -  Repeats of some screening tests        -  Ultrasounds of some glands. Researchers will put some gel on the face, then press on it          with a smooth wand.        -  Adults may have other biopsies        -  A small catheter inserted into the opening of the parotid gland duct on the inside of          the cheek. A saline solution (in a syringe) will fill the duct.        -  Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup        -  Scrapings collected from teeth, tongue, and cheeks   "
73183|NCT02327871|"     To control patient's body temperature remains of major importance especially after cardiac     arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most     unconscious CA patients. However, available modalities for inducing TH have a number of     technical (side effects), logistical (difficulties of placement), and financial (cost)     barriers. The Esophageal Cooling Device (ECD) is a multi-chambered silicone heat exchanger     placed in the esophagus providing highly efficient heat transfer to a patient. The ECD is a     device that potentially improves the effectiveness of TH in minimizing the risks of existing     methods (such as invasive cooling). Initial mathematical and animal studies have shown strong     support for the efficacy and safety of the ECD. Placement of a naso-gastric probe is a     systematic standard of care for all unconscious patients suffering from CA. The present study     will replace the usual naso-gastric probe by the ECD that can be used for gastric suctioning     as usually done in such patients.      The aim of this prospective, interventional study is to assess the feasibility and safety of     the ECD in resuscitated CA-patients and treated with 32-34°C targeted TH. The primary outcome     is the feasibility of inducing, maintaining, and rewarming patients from TH using the ECD     (cooling rate, rewarming rate, and the percent of time within goal temperature during the     goal-temperature maintenance period). Evaluation of adverse events (including cardiac     arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia,     aspiration pneumonia, non-aspiration pneumonia, esophageal reflux and injury, and     esophagitis) will be closely monitored during the whole period of the targeted temperature     management (secondary endpoint).   "
73184|NCT02327858|"     According to the World Health Organisation, depression and problem drinking are among the     leading causes of disability worldwide. Most patients who present with problem drinking     and/or depression have poor quality of life and pose a great economic burden to society due     to their higher use of health services. We seek to develop a new, enhanced, efficient,     innovative and cost effective treatment strategy aimed at reducing the burden that these two     mental conditions impose on sufferers, their families as well as the community and health     systems. In a recent pilot study of supportive text messages in Ireland conducted by the     Principal Applicant and a team of researchers for patients with problem drinking and     co-occurring depression, we established that patients who received twice daily supportive     text messages for three months had significantly less depressive symptoms than those who did     not receive such messages. There was also a trend that patients who received the supportive     text messages were more likely to have higher alcohol free days than those who did not     receive any supportive text messages.Our study was limited by the small number of     participants and it did not examine the impact of the text messages on health services     utilization. Our study did not also examine the effects of supportive text messages on those     with only depression or only problem drinking. The proposed study seeks to extend the     knowledge gained from the pilot study in Ireland by examining the impact of supportive text     messages in the individual disorders   "
73186|NCT02327832|"     Patients eligible for this study include those with decompensated liver cirrhosis with a     Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment     is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin     of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed     unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was     collected from the bilateral iliac crests under local anesthesia, heparin was added after     collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi     University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was     prepared by adding culture medium, and this was inoculated into a culture flask. After     subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary     endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.   "
73187|NCT02327819|"     Supplementation of BCAA found to reduce the risk of developing liver cancer, but the affect     of BCAA on existing liver cancer is unknown.      The participants (post curative intent surgery) will be supplemented with either     BCAA/non-BCAA-enriched protein supplement. The intervantion will go on for 2 years or until a     new liver tumor is found.   "
73188|NCT02327806|"     Pulsed electromagnetic field therapy (PEMFT) is a reparative technique most commonly used in     the field of orthopedics for the treatment of non-union fractures. The aim is to test the     effect of the magnetic induction on brute force of treated muscle in oncological patients.     Oncology patients were chosen as we assume that the ipmrovement will be more noticable in     oncology patients than in a non-oncology, healthy subjects.   "
73190|NCT02327780|"     Treatment of IBS is very problematic. Despite the wide range of pharmacological and     non-pharmacological therapies, there is no universally accepted approach. In recent years,     the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms     of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols)     are a group of dietary sugars that may be poorly absorbed in the small intestine and     fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in     fluid content in the colon and trigger functional gut symptoms in some individuals. This     study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms of     IBS compared to the standard dietary advice.   "
73191|NCT02327767|"     The goal of this project is to test a device (Zondervan et al, 2013) that can provide active     assistance for arm training for people in Vietnam with severe to moderate stroke, but that is     also simple and does not rely on powered actuators. The hypothesis is that individuals with a     severe chronic stroke, who exercise with a mechanically passive rehabilitation device, will     have improved arm movement ability without experiencing an increase in arm pain.   "
73192|NCT02327754|"     The purpose of this study is to investigate the effect of topiroxostat on urinary albumin     excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia     with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40)     for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.   "
73193|NCT02327741|"     1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than     that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were     compared to evaluate safety and feasibility of long term Plavix therapy post stenting.   "
73194|NCT02327728|"     To evaluate the efficacy of different botulinum toxin A injection patterns in treating benign     essential blepharospasm and to compare their influence on condition of eye surface .   "
73195|NCT02327715|"     This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant     HBsAg positive patients in prevention of HBV vertical transmission. Single group patients     were enrolled to receive emtricitabine till 24 weeks after delivery.   "
73196|NCT02327702|"     This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant     chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine     till 48 weeks after delivery.   "
73197|NCT02327689|"     This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV     related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related     cirrhosis patients and decompensated HBV related cirrhosis patients.   "
73198|NCT02327676|"     This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis B     patients. Single group of child patients were enrolled, which include HBeAg positive and     negative Chronic hepatitis B(CHB)group.   "
73199|NCT02327663|"     This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B     patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group     and HBeAg negative Chronic hepatitis B(CHB)group.   "
73200|NCT02327650|"     Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and     others have previously reported, a portion of OA might be caused primarily by bone     alterations. In this study, we prospectively and retrospectively show that the bone     altertations may affect OA primarily in all of the joints.      In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks     synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The     etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone,     instead of cartilage. Here we prospectively and retrospectively show that the bone     altertations may affect RA primarily in all of the joints.   "
73201|NCT02327637|"     Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the     lack of data to support its benefits, and increasing evidence pointing to potential harms. In     this study, the effects of bed rest compared to moderate activity will be on maternal mood     and muscle strength will be evaluated in patients with preterm premature rupture of membranes     (PPROM).   "
73202|NCT02327624|"     The principal hypothesis of this study is that two different maintenance regimens of     ticagrelor are safe, tolerable and associated with significant inhibition of erythrocyte     adenosine reuptake compared to clopidogrel in patients undergoing elective Percutaneous     Coronary Intervention (PCI) for stable Coronary artery disease (CAD).   "
73221|NCT02327351|"     Treatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta     depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and     unrelated donors in patients with primary immunodeficiency diseases   "
73203|NCT02327611|"     Postoperative renal failure is the most significant risk factor for early mortality after     elective surgical repair of thoracoabdominal aortic aneurysms (TAAAs).      To prevent damages related to kidney ischemia during aortic crossclamping and TAAA repair,     the most recent guidelines recommend the use of cold crystalloid or blood perfusion. Since     the most studied crystalloid solution is the Ringer's lactate solution, this can be     considered the standard of care for evaluating the effectiveness of other substrates.      An histidine-tryptophan-ketoglutarate enriched crystalloid solution named Custodiol (Dr.     Franz Kohler Chemie GmbH, Bensheim, Germany) is currently used for organ preservation during     transplantation and for cardioplegia during open-heart surgery in most EU countries. This     solution may provide a better grade of renal protection to ischemic damage than the standard     crystalloid solutions.      A recent observational study published by our group suggested a lower incidence of     postoperative renal kidney injury in patients undergoing open TAAA surgical repair using     renal perfusion with Custodiol, as compared to those perfused with an enriched Ringer's     lactate solution.      Objective of this study is the confirmation of the promising findings about the effectiveness     of renal perfusion with Custodiol during repair of TAAA compared with other crystalloid.      The study will be a prospective, single-center, randomized, double-blind, controlled trial,     investigating Acute Kidney Injury in patients undergoing TAAA open repair using Custodiol     renal perfusion versus an enriched Ringer's lactate solution. It is expected to enroll adult     patients undergoing elective TAAA open repair. Participants will be followed for the duration     of hospital stay, an expected average of 2 weeks.   "
73204|NCT02327585|"     ADHD children have executive function (EF) impairments,so we randomize the children to the     training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF     deficits are amenable to the training in children with ADHD.   "
73205|NCT02327572|"     This research project aims to study this intriguing relationship between ageing and breast     cancer biology, and more specifically the changes that occur within the tumor     microenvironment with increasing age. Furthermore, it will focus on the link between these     microenvironmental changes and organismal ageing (as measured by chronological age, geriatric     evaluation of elderly patients, and circulating biomarkers of ageing), since it seems logical     that age-related changes in the stromal part of a tumor (fibroblasts, immune cells,     endothelial cells, fatty cells, …i.e. host cells) are due to the ageing process of the entire     body. Most particularly, the amount and type of infiltrating immune cells might reflect the     degree of immunosenescence of the host. More and more research points out the crucial role of     the immune system in tumorigenesis and progression, and, at the same time, the immune system     is one of the most affected components in the process of ageing. .   "
73206|NCT02327559|"     The purpose of this small randomized controlled trial (RCT) is to compare the impact of a     brief (16 hour) 3rd trimester mindfulness-based childbirth education program, Mind in Labor     (MIL): Working with Pain in Childbirth, with a standard care/treatment as usual (TAU)     active control condition of standard hospital- and community-based childbirth education. The     MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing     and greater childbirth self-efficacy), less perceived pain in labor, less use of pain     medication in labor, greater birth satisfaction, and better prenatal and postpartum     psychological adjustment compared to the TAU group.   "
73207|NCT02327546|"     The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548     with ferrous sulfate relative to AKB-6548 in healthy volunteers.   "
73208|NCT02327533|"     In this study, the investigators evaluated molecular biomarkers which play a role in the     development of generalized aggressive periodontitis (GAgP) using gingival tissue samples     through omics-based whole-genome transcriptomic while using healthy individuals as background     controls.   "
73209|NCT02327520|"     The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand     Nationwide Hospital Admission Database, which is part of the National Health Security Office     (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes,     either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The     inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile     (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was     excluded. The baseline characteristics, including age, sex, co-morbidity disease and history     of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital     stay (LOS), mortality rate, and hospital charge.   "
73210|NCT02327507|"     Dental caries (tooth decay) is a disease with significant public health implications     afflicting low-income children, with marked rural disparities in disease prevalence and     treatment. More than 70% of 11th grade children in Crook, Deschutes and Jefferson counties     have experienced tooth decay. Effective approaches to prevent decay include brushing with     fluoridated toothpaste and professional dental care. Medicaid enrolled children are legally     entitled to dental care under Early Periodic Screening, Diagnosis and Treatment (EPSDT), yet     <50% had any care in 2010. Free distribution of toothpaste and toothbrushes combined with     parental education can increase toothbrushing frequency and reducing tooth decay. However,     many parents are confused about when to start, how much and often toothpaste should be used,     and how to overcome behavioral difficulties in brushing toddlers' teeth or getting older     children to brush their own. The investigators' objective is to implement and evaluate a     community-wide toothpaste distribution campaign enhanced by telephone support for OHP     children and adolescents and their families in Central Oregon   "
73218|NCT02327390|"     This phase I trial studies the safety and best dose of ex-vivo activated lymph node     lymphocytes (X-ACT) as well as how well the immune system responds to X-ACT treatment in     participants with stage IIIC-IV melanoma. X-ACT treatment involves removing a participant's     lymph node(s) close to a melanoma tumor. These lymph nodes contain special kind of cells     (called T cells) which can be activated (getting the cells to start up certain responses in     the immune system) outside of the body in an approved laboratory. The activated T cells are     then injected back into the same participant using an i.v. to help the participant's immune     system to target melanoma. The participant will undergo regular blood testing to determine     whether the X-ACT treatment has resulted in changes to the immune system and also whether the     T cells which were given back to the patient persist in the blood stream over time. In     addition, the effect of the X-ACT treatment on the growth or shrinkage of the participant's     melanoma will be measured.   "
73211|NCT02327494|"     Anesthesia favouring deep/intense neuromuscular blockade during laparoscopy may restore     hemodynamics. However, no studies has been performed comparing oxygenation parameters during     laparoscopy in colorectal surgery in either moderate or intense neuromuscular blockade.      The investigators aim to investigate whether the intense neuromuscular blockade produces a     better oxygenation profile measured by the central venous oxygen saturation than the moderate     neuromuscular blockade.      This is a one centre, prospective clinical trial to compare oxygenation data at different     stages of neuromuscular blockade in high-risk patients scheduled for colorectal surgery. Data     recording will be blinded to the anesthesiologist in charge of the patient, who will manage     patients by a determined protocol, based on stroke volume data to direct fluidotherapy. Data     analyzer will be not be involved in the study design or in writing reports from the study.     Inclusion criteria: Be a candidate to a colorectal surgical resection procedure and one of     these conditions: ≥ 70 y.o, or respiratory co-morbidity, or cardiac co-morbidity or     haemoglobin level < 11g/dl. The primary outcome is the absolute number of the central venous     oxygen saturation, measured at the following points: basal, after tracheal intubation, before     pneumoperitoneum or abdominal incision, after pneumoperitoneum or abdominal incision, 5 and     10 minutes before administration of rocuronio to produce intense blockade, continuously     during profound neuromuscular blockade until the end of surgery, before sugammadex     administration, after sugammadex administration, after tracheal extubation, for the 24 hours     post surgical. Data of the regional cerebral oxygen saturation will be measured at the same     points.      The investigators hypothesize that oxygenation data will be favourable by applying the     intense neuromuscular blockade in comparison with moderate neuromuscular blockade. Also, the     investigators hypothesize that oxygenation data obtained during the whole procedure including     the first 24-hours post-surgery, measured by the regional cerebral oxygen saturation are     comparable to data obtained by the central venous oxygen saturation. The investigators want     to obtain information about influence in the outcome of producing profound neuromuscular     blockade during laparoscopy colorectal by comparison of outcome data with matched historical     control.   "
73212|NCT02327481|"     The purpose of this study is to explore the feasibility of 3D Laparoscopic Surgery for     Gastric Cancer.   "
73213|NCT02327455|"     The specific aim of this clinical trial is to translate the investigators new 4DE (three     sptial dimensions pluse time) stress echocardiographic method to patients with coronary     artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the     reproducibility of the technique in this clinical setting.   "
73214|NCT02327442|"     The purpose of this study is to assess the safety, biodistribution, dosimetric properties of     the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To     preliminarily evaluate its application in glioma diagnosis.      To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant     chemotherapy in patients with breast cancer before and after the therapy.   "
73249|NCT02326987|"     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption     by Extending the Absorption Site.      To overcome the shortcomings of the currently existing sustained release drug delivery     technologies the investigators have recently developed a novel drug delivery system to enable     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).   "
73215|NCT02327429|"     In Canada, there is a fast-growing population with diabetes, and the majority of diabetes     cases are type 2 diabetes (T2D). Diabetes and its complications, such as cardiovascular     diseases, eye disease and foot disease, impair the quality of life and life expectancy.      Chinese are the second largest visible minority in Canada. The diabetes incidence increased     much more rapidly in the Canadian population of Chinese origin compared with that of European     origin in past decades. Cultural factors are very likely to affect individual behaviour in     diabetes treatment. Both international and Canadian diabetes organizations have recognized     the importance of taking into account the cultural background and individual preferences in     diabetes treatment.      However, there lacks cultural relevant nutritional recommendations or guidelines for Chinese     Canadians except some literally translated materials which may not be culturally relevant. In     order to fill the gap, the investigators have developed a Chinese menu plan that includes     commonly consumed Chinese dishes with nutrients breakdown and cooking tips to provide     guidance for patients in their daily meal planning. This menu plan is a cultural translation     of the Canadian nutritional guidelines, which is urgently needed among Chinese immigrants     with T2D in Edmonton, according to our previous needs assessment.      In this pilot test, the investigators will examine the feasibility and effectiveness of the     Chinese menu plan. Twenty Chinese with T2D in Edmonton will be recruited to use the menu plan     for 3 consecutive months and relevant indices of T2D will be tested as indicators of     effectiveness. Feedback from participants will be obtained through one-on-one interviews and     appropriate modifications will be made to the menu plan.   "
73216|NCT02327416|"     This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial to     assess the efficacy and safety of combination and sequential treatment with Y peginterferon     Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or nucleosides     experienced. Patients were randomized to one of 3 groups to receive different antiviral     treatment.   "
73217|NCT02327403|"     Background: Proteinuria develops in about 30% of kidney transplant recipients and is a strong     predictor of graft loss. The amount of proteinuria has a direct correlation with the risk of     graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent graft     loss in transplant recipients, since ACE inhibitors carry a number of limitations in the     transplant setting, including significant reduction in renal function, anemia and     hyperkalemia.      Preliminary data: B7-1 is expressed at significant levels in about 10% of kidney allograft     biopsies with predominance in patients with proteinuria.      Hypothesis: We hypothesize that B7-1 targeting therapy may reduce proteinuria and improve     graft survival in proteinuric transplant recipients that have B7-1 staining on allografts. In     addition, the absence of CNI nephrotoxicity and the potential protective effect of Belatacept     on DSA production may be of benefit in this subset of transplant patients.      Objectives:      Primary: Determine the effect of Belatacept conversion in reducing proteinuria by 25% at 12     months in renal transplant recipients (≥1gram/d) that are either B7-1-positive or negative on     kidney biopsy.      Secondary: Assess the effect of Belatacept conversion in the percent change of renal function     from baseline to 12 months; donor-specific anti-HLA antibodies presence and intensity (MFI);     correlation of B7-1 positivity on immunofluorescence on biopsy with B7-1-expression in urine     extracellular vesicles; adverse events; acute rejection episodes; blood pressure control; new     onset diabetes; hyperlipidemia; graft survival; and patient survival.   "
73233|NCT02327195|"     The purpose of this study is to assess whether methylphenidate affects time of emergence from     isoflurane general anesthesia. Time to emergence was defined as the time from termination of     isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths     spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated     and the time will be recorded.   "
73222|NCT02327338|"     Objective- To see if the use of heat at home between physical therapy sessions results in     better therapy outcomes in people with acute neck pain.      Setting: Physical Therapy outpatient rehabilitation center Participants: 90 people with acute     nonspecific neck pain broken into 4 groups. Intervention: All subjects will undergo 45     minutes of therapy 2 times per week for 2 weeks. All subjects will accomplish 1 hour of     therapeutic exercise at home on days when there is no therapy. Thirty of the subjects will     use ThermaCare neck wraps before home exercise, 30 used Ibuprofen plus ThermaCare neck wraps     before home exercise, 15 will use a sham heat wrap and an Ibuprofen placebo each day (1200 mg     / day) and the last 15 will be controls with conventional physical therapy.   "
74860|NCT02305901|"     To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs     repaglinide and bupropion as a means of predicting drug-drug interactions.   "
73223|NCT02327325|"     Chronic low back pain (cLBP) is one of the most common and disabling conditions among US     military Veterans. Although physical activity can improve cLBP outcomes, the majority of     Veterans with cLBP are inactive. Therefore the VA is in need of effective programs that can     help older Veterans with cLBP to increase their physical activity and improve associated     outcomes. This is particularly relevant for older Veterans with cLBP who are at greater risk     for functional limitations. The proposed project will be a pilot study of a telephone-based     physical activity program or physical activity combined with cognitive behavioral pain     management for older adult Veterans with cLBP. Older Veterans are of particular interest     because prior studies of physical activity for cLBP have not addressed this vulnerable     patient group. This study will also inform the VA about whether certain patients with cLBP,     who have greater pain sensitivity, may benefit from other treatment to supplement a physical     activity program.   "
73224|NCT02327312|"     To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per     study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma   "
73225|NCT02327299|"     Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem,     especially in developing countries. There are several strategies to correct iron deficiency     in populations: besides supplementation with tablets, one of the most sustainable and     effective strategies on medium term has been iron fortification, the addition of iron to     regularly consumed foods. In fortification, the chemical nature of the compound to be added     plays an important role: depending on the compound sensory qualities of the fortified foods     can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate     (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast     cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on     the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to     bouillon, as was recently suggested by in vitro experiments in the laboratory.   "
73226|NCT02327286|"     Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program     implemented within the first year after a pregnancy complicated by gestational diabetes     (GDM), in delaying or preventing the development of type 2 diabetes.   "
73227|NCT02327273|"     The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics     (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in     healthy subjects.   "
73228|NCT02327260|"     This project will pilot test an intervention to increase participation rates in cardiac     rehabilitation and medication adherence among patients following a cardiovascular event. The     intervention will use an educational video shown during referral to cardiac rehabilitation     (before hospital discharge), along with a brief, telephone-delivered counseling session to     increase motivation to participate in cardiac rehabilitation and take all cardiac medications     as prescribed (following hospital discharge). One hundred twenty patients who have     experienced a cardiovascular event, and who are eligible for cardiac rehabilitation, will be     recruited to participate in the study. Three groups of participants (40 each) will be formed:     a control group that receives standard care, a first experimental group that sees the     educational video and receives motivational counseling to attend cardiac rehabilitation, and     a second experimental group that receives motivational counseling to adhere to their     medications as prescribed. It is expected that the experimental group participants will     differ from the control group participants in rates of participation in cardiac     rehabilitation (experimental group #1) and medication adherence (experimental group #2). If     successful, this intervention could be used in hospital settings to increase patients'     adherence behaviors.   "
73229|NCT02327247|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended     release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories,     Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)     manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP     Wilmington, DE 19850 in healthy, adult, male, human subjects under fasting condition.   "
73230|NCT02327234|"     The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen     challenge testing and will investigate whether ibuprofen changes the response.   "
73231|NCT02327221|"     The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of     an autologous antigen-specific regulatory type 1 T lymphocyte expanded population     administered via the intravenous route as an infusion.      The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and     multi-injection study; followed with a 16-week phase with either the possibility for an     open-label treatment part or a safety follow-up part with no injection.      Then, the patients will be followed in an additional long-term safety follow-up, of maximum     duration of 3 years from the first administration.   "
73232|NCT02327208|"     The objectives of this study are to: 1) determine effects of a prototype recovery food     product providing supplemental energy on whole-body protein balance, skeletal muscle mass,     and biomarkers of physiological status and strain during winter military training, and 2)     determine the extent to which varying macronutrient composition (protein-based [PRO] versus     carbohydrate-based [CHO]) of the food product modulates the physiological consequences to     strenuous military training.   "
73273|NCT02326662|"     This research investigates the use of autologous neural stem cells in patients with complete     traumatic spinal cord injury.   "
73234|NCT02327182|"     The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666     administered once daily for 52 weeks with or without receiving a concomitant     acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's     Disease (AD).   "
73235|NCT02327169|"     The primary purpose of this study is to determine the safety profile and the maximum     tolerated doses (MTDs/potential recommended phase 2 doses (RP2Ds) of the combination     treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 +     cetuximab, and MLN2480 + irinotecan in patients with advanced nonhematologic malignancies.   "
73240|NCT02327104|"     The dependence on tobacco is a predictable leading cause of death. The treatment based on the     cognitive-behavioral therapy, including relapse prevention, became standard for tobacco     dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based     Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The     purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in     the treatment of smoking cessation instituted by the Ministry of Health, through the     Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with     a simple random allocation. 60 patients will participate in this study receiving treatment     (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo     eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the     traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark     to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil).     Changes will be evaluated on several variables such as cessation of smoking, anxiety,     depression, craving, positive and negative affects and will investigate the association of     levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and     four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the     study, besides being subjected to evaluations of regularly planned maintenance in the     protocol of Ministry of Health. For data analysis there will be used Analysis of Variance     with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect     of two types of intervention on the evolution of comorbidities and abstinence of patients.   "
73241|NCT02327091|"     The age-related increase in falls is strongly associated with a decline in muscle strength by     the mechanism of sarcopenia. There has been great interest in developing approaches to     counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle     mass with vitamin D that have muscular effect. However, a limited number of studies     demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in     adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted     in order to determine the effect of alfacalcidol on the upper-body muscle strength in     Indonesian elderly women in age group of 60 or more who had low handgrip strength.   "
73242|NCT02327078|"     This is a Phase 1/2, open label study that will be conducted in 2 parts. The first part of     the study (Phase 1) will consist of a dose-escalation assessment of the safety and     tolerability of epacadostat administered with nivolumab in subjects with select advanced     solid tumors and lymphomas including melanoma (MEL), non-small cell lung cancer (NSCLC),     colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), ovarian cancer, and B     cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL). The second part (Phase 2) of the     study will include expansion cohorts in the tumor types tested in Phase 1 (except diffuse     large B-cell lymphoma (DLBCL) will be the only lymphoma permitted and Phase 2 will also     include a cohort for glioblastoma) with a) historically good activity with nivolumab     monotherapy, and b) with historically low activity with nivolumab monotherapy.   "
73243|NCT02327065|"     The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on     pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.   "
73244|NCT02327052|"     One of the most challenging issues of chronic Chagas disease is to provide earlier detection     of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new     imaging modality with useful applications in several cardiac diseases, has been validated for     subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the     investigators hypothesize that the longitudinal global strain (LGS) has an incremental value     to ejection fraction for predicting myocardial fibrosis in subjects with Chagas disease.   "
73245|NCT02327039|"     In Phase 2b/3 clinical trials, Dapagliflozin has been shown to raise HDL cholesterol levels     by about 4 mg/dl (1 mmol/l), which is generally considered a clinically-meaningful change. As     this HDL cholesterol increase is carried out with concomitant improvement in glucotoxicity     and body weight reduction, it is possible that treatment with Dapagliflozin also improves HDL     function. This is important because clinical, epidemiological and experimental studies     indicate that HDL function may be more important than HDL cholesterol levels in determining     the protective cardiovascular effects of HDL particles. In addition, knowing the effects of     Dapagliflozin on HDL function can help interpreting the increase in HDL cholesterol levels     observed in Dapagliflozin-treated patients. Finally, discovery of extra-glycemic effects of     Dapagliflozin will shed new light on the potential benefits of therapy with Dapagliflozin and     SGLT2i in general. So far, no study evaluated the effects of Dapagliflozin (or other SGLT2i)     on HDL function.      The investigators hypothesize that Dapagliflozin, in addition to raising HDL cholesterol     levels, also increases HDL functionality, measured as reverse cholesterol transport and     anti-oxidant capacity, in patients with T2DM   "
73246|NCT02327026|"     The aim of this study is to improve the management of patients in cardiac arrest, and this by     comparing two initial airway management methods: Tracheal intubation and bag-valve-mask     ventilation.      The survival rate at 28-day with favorable neurological function will be compared in the     tracheal intubation group versus the bag-valve-mask group   "
73247|NCT02327013|"     The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult     patients with ADHD in a 12 weeks study.   "
73275|NCT02326636|"     The purpose of this research is to investigate the efficacy of transplanting screened donor     fecal material in treating patients with recurrent Clostridium difficile infection.     Participants with refractory Clostridium difficile infection will be given healthy donor     stool administered by colonoscopy or enema and their response will be evaluated by symptom     questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.   "
73248|NCT02327000|"     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption     by Extending the Absorption Site.      To overcome the shortcomings of the currently existing sustained release drug delivery     technologies the investigators have recently developed a novel drug delivery system to enable     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).   "
73250|NCT02326974|"     This research study is studying a combination of drugs as a possible treatment for breast     cancer that has tested positive for a protein called HER2.      The names of the study interventions involved in this study are:        -  Trastuzumab emtansine (also called T-DM1)        -  Pertuzumab   "
73256|NCT02326896|"     Risk factors for difficult intubation are well described in anesthesiology. But intubation in     the intensive care unit (ICU) is a challenging issue, associated with severe life-threatening     complications. Non-anesthesiologist trainees performing ICU intubation may not fully     appreciate the potential difficulty and complications.      Therefore in this retrospective analysis the MACOCHA score will be used to determine     difficult intubation in the ICU and predict intubation failure.   "
73257|NCT02326883|"     This pragmatic clinical trial will evaluate the effectiveness of two population-based     outreach programs for preventing suicide attempts among patients identified as at-risk. The     study will be conducted at Group Health (the lead site) and at HealthPartners and KP     Colorado. Electronic health records will be used to identify outpatients aged 18 or older who     respond to a routinely administered PHQ depression questionnaire by reporting thoughts of     death or self-harm most of the days or nearly every day. This trial will be limited to     patients receiving care from one of the three participating health systems. Eligible patients     will be automatically assigned to continue in usual care (1/3) or to either of the two     intervention programs (1/3 each). Those assigned to usual care will not be contacted at all     by study staff and will continue to receive usual care from treating primary care and mental     health providers. Both intervention programs involve outreach by Epic secure messaging (with     optional telephone outreach for those not reading messages). The Care Management intervention     includes routine outreach to assess ongoing risk of suicide attempt and care management to     monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will     coordinate care with treatment by primary and behavioral health care providers using Epic     Staff Messaging (or telephone contacts if necessary). The Skills Training intervention uses     an online skills training program to support patients in developing and using self-management     skills for emotion regulation and crisis management. A Coach will monitor each participant's     use of the program and send periodic messages (using Epic secure messaging) to encourage and     support use of the program and practice of program skills. Each intervention continues for up     to one year. In all three groups (Usual Care, Care Management, and Skills Training) virtual     data warehouse data will be used to identify likely suicide attempts over 18 months following     randomization. Analyses will compare risk of suicide attempt among all those randomized,     regardless of response to the initial invitation or level of participation in the     intervention programs. Comparison of all those randomized is the only scientifically valid     method for assessing the overall impact of either program on population-level risk of suicide     attempt.   "
73258|NCT02326870|"     The main objectives of this study are to evaluate the performance and ease of use of the     Follow me mode of the AutoLap system during general and gynecological laparoscopic     procedures.   "
73259|NCT02326857|"     Background:      - Researchers want to learn more about breast cancer in Latin American women. They also want     to learn how and why women respond differently to standard treatment. Tissue and blood     samples from women with breast cancer are needed to study this disease in order to find new     ways to prevent, diagnose, and treat it.      Objective:      - To learn more about the biology and genetics of breast cancer in Latin American women.      Eligibility:      - Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II     or III breast cancer. They must still be active and able to self-care.      Design:        -  Participants are only agreeing to have extra tissue or blood samples collected. They are          also letting tissue left over from surgery be used for research. No procedures outside          of standard care will be done.        -  Participants may have a medical history, physical exam, and blood tests. They may have a          pregnancy test. They may have an ultrasound, mammogram, and other scans. They may have          an intravenous needle placed in an arm vein.        -  Participants may have a core biopsy. For this, a needle is inserted into the breast. A          piece of tissue is extracted.        -  Participants who have chemotherapy may have blood taken after treatment/before surgery.          Tissue may also be collected.        -  Participants will complete a questionnaire. It will ask about their social and economic          background. It will ask about their family history of cancer. It will also ask about          access to diagnosis and treatment of breast cancer.        -  Participants may be followed for up to 5 years.   "
73260|NCT02326844|"     Background:      - The new drug BMN 673 (talazoparib) has been shown to fight tumor cells in animals and some     people. It is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works on tumor cell     deoxyribonucleic acid (DNA) damage repair process. Researchers want to see if BMN 673 shrinks     cancer again in women with ovarian cancer and whose cancer initially got shrunk but grew back     on the first PARP inhibitor.      Objective:      - To study BMN 673 (talazoparib) in people with ovarian cancer born with a breast cancer     (BRCA) mutation and whose cancer got shrunk but became worse after they took a similar drug.      Eligibility:        -  Women at least 18 years old:        -  with recurrent and/or metastatic germline breast cancer mutation (gBRCAm)-associated          ovarian cancer AND        -  whose disease is growing after already being treated with PARP inhibitors AND        -  with no other treatment(s) in between the first PARP inhibitors and a screening visit.      Design:        -  Participants will be screened with medical history, physical exam, and heart and blood          tests.        -  Participants will take the study drug by mouth once daily. They will take the drug in          28-day cycles.        -  They will keep a diary of doses and any side effects.        -  Participants will have 4 study visits in cycle 1, then 1 visit every cycle. Visits may          include:        -  Blood tests        -  Physical exam        -  Computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will          lie in a machine that takes pictures of their body.        -  Ultrasound        -  Participants will have a biopsy before starting the study drug. A small piece of tumor          tissue will be removed by needle, guided by a scan. They may have two more biopsies          later.        -  Participants will be followed for 30 days after taking the last dose of study drug. A          physical exam, blood tests, and CT or other scans will be done.        -  Participants will have follow-up calls to ask about any side effects.   "
73274|NCT02326649|"     This study will test the capability of a non-invasive instrument (the PhysioFlow impedance     cardiography instrument) to measure cardiac output in patients with congenital heart disease     (CHD). This instrument works by placing electrodes on the skin of a patient and measuring     electrical impedance through the chest, which is proportional to blood volume and blood flow     at any given time. The instrument has been validated in patients with structurally normal     hearts, but in the only two studies using it for patients with CHD, it was deemed too     inaccurate for clinical use. The manufacturer of the device would require access to data on     the patients in order to improve its accuracy, and that has not been feasible thus far. This     study would begin by comparing cardiac output based on the PhysioFlow monitor to standard     techniques, then after possible changes to the instrument to enhance accuracy, would test the     instrument again in the same way.   "
73261|NCT02326818|"     Background:      - It is hard for people with arm spasticity and focal hand dystonia to control their arm and     hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography     with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT     injection. Researchers want to learn which method is faster and more comfortable.      Objective:      - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand     dystonia and upper limb spasticity.      Eligibility:      - Adults 18 and older with focal hand dystonia or arm spasticity who have been getting     onabotulinumtoxin-A injections in protocol 85-N-0195.      Design:        -  Participants will be screened with medical history and physical exam.        -  Participants will push or pull on a device that measures arm strength. They will have a          neurologic exam. Women will have a pregnancy test.        -  Participants will have a BoNT injection using either e-stim or ultrasound.        -  For e-stim, sticky pads will be placed on the arm. A needle will be placed in the          muscle. A small electric shock will be given through the needle. Then the injection will          be given.        -  For ultrasound, a probe will be moved across the skin. A screen will show an image of          the muscles. Then the injection will be given.        -  Participants will have a second injection 3 months later. They will have the method that          was not used for their first injection.        -  After each session, participants will rate their experience.        -  Participants will have follow-up visits 1 month after each injection. They will be          examined and asked about their response to treatment. Arm strength will be measured.   "
73262|NCT02326805|"     This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen     [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer     undergoing active surveillance. Vaccines made from a person's tumor cells may help the body     build an effective immune response to kill tumor cells that express PSA.   "
73263|NCT02326792|"     The fatigue of the trunk extensor muscles is often reported in people with the chronic low     back pain (LBP). Evidences have showed that the strengthening muscular by the training of the     lumbar spinal muscles is efficient to decrease the pain and disability symptoms of patients     with the chronic LBP. Also, some studies have reported improve of the strength and endurance     of the back muscles from of this type of training muscular. However, the exercise     prescription for the trunk extensor muscles during the training is still not clear in the     literature. In fact, no study has showed any differences between one and three sets of     specific lumbar exercise with regard to better prescription of training in healthy subjects     (e.g; preventive action) as well as in LBP subjects (e.g; intervention action).   "
73264|NCT02326779|"     The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage     II-III esophageal cancer patients.   "
73265|NCT02326766|"     This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting     plasma metabolomes.   "
73266|NCT02326753|"     The purpose of this study is to assess the adequacy of mask ventilation with the different     sized-oropharyngeal airway.   "
73267|NCT02326740|"     The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of     pyoderma gangrenosum (PG).   "
73268|NCT02326727|"     Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer     cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer     Registry has noted an improved 5-year survival in patients who received epidural analgesia     during surgery for colorectal carcinoma.   "
73269|NCT02326714|"     The purpose of this trial is to investigate the effect and safety of auricular acupressure on     adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms:     Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for     three months. Body mass index, oral glucose tolerance test, hormonal profile and metabolic     profile will be determined.   "
73270|NCT02326701|"     Echocardiographic assessment of right ventricular function is an important diagnostic tool,     and is a challenge due to the unique structure and anatomy of the right ventricle. Lately a     new technique has been developed and used for evaluating both the left and the right     ventricle function. This technique, called two dimensional (2D) speckle tracking, is based on     detecting speckles in the myocardial tissue and using them as acoustic markers. The movement     of these speckles represents the movement of the tissue, and allows us to evaluate its     function, contraction and relaxation, this by calculating the strain rate, which is the speed     of the speckles, and the strain, which is the distance between them.      In the last few years this technique has been used to evaluate the systolic function of the     right ventricle in several pathological conditions, such as pulmonary hypertension, pulmonary     embolism and amyloidosis. Nonetheless, so far there has been little data on the normal RV     strain and strain rate values.      In this study the investigators aim to validate two dimensional (2D) speckle tracking     measurements of the RV function by comparing them to strain measurements by cardiac MRI. Each     patient performing cardiac MRI for any indication will perform an echocardiography     examination in addition, and strain analysis performed on the cardiac MRI will be compared     with two dimensional speckle tracking analysis performed on the echocardiography.   "
73271|NCT02326688|"     Reproducibility assessment of a quantitative measure of the amount of trunk compensation by     kinematic analysis in a grasping task in stroke patients.This maladaptive trunk     compensation is suspected to be underlined by arm non-use in some patients, since this     abnormal movement impairs the ability of patients to correctly flex their shoulder and extend     their elbow during grasping.   "
73272|NCT02326675|"     Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to     the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to     treat the cancer. A number of treatment factors have been shown to influence the incidence     and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy     before stem cell transplantation can cause severe oral mucositis and is often the side effect     that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth     during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by     high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One     other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of     the study are: 1) to assess tolerability of cryotherapy given during chemotherapy     administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced     mucositis.   "
73310|NCT02326181|"     The study will investigate the effects of different training types ,including combined     inspiratory with expiratory pressure threshold training,inspiratory pressure threshold     training on patients with chronic obstructive airway disease and investigate whether     expiratory pressure threshold training associated with inspiratory pressure threshold     training would be better than inspiratory pressure threshold training alone, with regard to     exercise capacity, respiratory muscle strength and endurance.   "
73276|NCT02326623|"     Many medical procedures aimed at helping children can cause them pain and distress. If     children have certain levels of pain or distress, it can have long lasting negative effects.     The emergency department can be a very stressful place for children and their parents. There     are also many procedures that children may have in the emergency department that can cause     pain and distress. These include procedures such as needle pokes, stitches, or setting a     broken bone. Two common methods of managing a child's pain in the emergency department are     drugs and distraction. Drugs are not always practical and may come with unwanted side     effects. Distraction is often used by parents or health professionals to help children deal     with pain and stress. Distraction can lower the child's pain and distress by moving their     attention from the painful experience, for example a needle poke, to a more positive feeling     such as watching a movie, playing a game, or listening to music. This study will test if     iPads are useful to help lower pain and distress for children (ages 6 to 11 years) who are     visiting an emergency department and need an intravenous line put in. The results from this     study could be important for many children receiving medical care, as distraction is safe and     the use of iPads is enjoyable for many children.   "
73277|NCT02326610|"     SGA Infants who do not show a developmental catch-up growth within the first 6 months of life     fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in     partial hGH/IGF-I deficiency.      Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I     deficiency in SGA children can be the major or contributory cause of to their     neurodevelopmental deficits      To assess the effect of early growth hormone treatment given to symmetrical small for     gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and     growth between birth and 6-12 months.      The study is an innovative research not previously performed for improving neurodevelopmental     outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has     not been reported, however based on multiple studies assessing use of GH in infants and young     children, it is reasonable to similarly expect no short and long-term adverse effects.      The study will take place at the Tel Aviv Medical Center only.   "
73278|NCT02326597|"     Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations     affecting 100,000 individuals in the US, largely of minority origin and associated with     substantial morbidity, premature mortality, individual suffering, healthcare costs and loss     of productivity. Disease modifying treatments such as Hydroxyurea, chronic blood transfusion     and curative bone marrow transplantation are offered to patients based on physician     preference and current practice informed by clinical trials. Decision aids are tools that     could help translate evidence from these sources into practice by helping clinicians involve     patients in making deliberate choices based on accessible information about the options     available and their outcomes and to help them make decisions based on their values and     preferences.      The overarching goal of this project is to develop and implement a web based decision aid     individualized to patient characteristics to help patients with SCD achieve more accurate     perception of risks and benefits of treatment options and make decisions in congruence with     their values and preferences.      The investigators will conduct needs assessment interviews as indicated by the data for     saturation and validation of findings. The investigators will conduct beta testing of the     web-based decision aid to clarify development and validate findings. The investigators will     use a randomized controlled trial of the effectiveness of a web-based decision aid to give     patients accurate information about risks and benefits of therapies and enable them to make     decisions based on their individual values and preferences.      To provide accurate information to patients and caregivers about the risks and benefits of     various treatments for sickle cell disease and to enable them to make informed and involved     therapeutic decisions based on their values, preferences and stated goals.   "
73279|NCT02326584|"     This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself     (monotherapy) or in combination with other standard treatments. The main purpose of this     study is to find the best dose and schedule for SGN-CD33A when given in combination with     standard induction treatment, in combination with standard consolidation treatment, or by     itself for maintenance treatment. This will be determined by observing the dose-limiting     toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In     addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will     be assessed.   "
73280|NCT02326571|"     Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH)     constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the     larger population of patients suffering from cerebral thrombosis. Development of brain edema     seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is     only understood fragmentarily.      By using multimodal neuro monitoring, the investigators seek to investigate     electrophysiological and metabolic processes, which seem to accompany the formation of edema     and clinical deterioration in patients suffering from sICH.   "
73281|NCT02326558|"     The purpose of this study is to evaluate the feasibility, safety and efficiency of zero     ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional     laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.   "
73282|NCT02326545|"     Anxiety is the most prevalent form of children's mental health problems and demand far     exceeds treatment availability. Even when children do have access to care, evidence-based     treatments such as cognitive-behavioural therapy have several limitations: they are largely     didactic, leaving children unmotivated and disengaged; children get little practice in using     the skills they are taught, creating a large gap between their knowledge and their everyday     behaviour and therapy is costly, often prohibitive for the children that most need it.     Therapeutic video games can address each of these gaps: they are engaging contexts through     which children practice skills (rather than memorize lessons), and they cost substantially     less than conventional approaches. The proposed research will test the effectiveness of     MindLight, an innovative video game that targets childhood anxiety problems. MindLight     incorporates several evidence-based strategies including relaxation and exposure techniques,     attention bias modification methods, and neurofeedback mechanics that together produce an     immersive game world through which children learn to manage and overcome anxiety symptoms.     Two randomized controlled studies with 8-16 year old children are proposed to test the     effectiveness of MindLight in reducing anxiety: the first is a prevention study aimed at     children at risk for developing serious anxiety problems and the second is a clinical trial     aimed at decreasing symptoms in anxiety-disordered children. Children randomly assigned to     the intervention group will play MindLight for 5 hours over 2-3 weeks; control participants     in the prevention sample will play a commercial video game with a similar theme for the same     amount of time whereas control participants in the clinical sample will use an online     cognitive behavioural therapy (CBT) program. Both studies will assess children's anxiety     levels before the intervention, just after, and at a 3-month follow-up. Moderators (e.g.,     comorbidities) and mediators (e.g., attention biases) will be assessed to identify potential     mechanisms of change associated with successful intervention effects.   "
73283|NCT02326532|"     The overall goal of this proposal is to address barriers to the use of patient reported     outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.   "
73285|NCT02326506|"     Veno-arterial extracorporeal life support (VA-ELS) is used to support patients with acute     cardiac failure. In that context, sufficient drainable venous volume is crucial for reliable     and adequate support. To date, no reliable measurement method exists to monitor drainable     volume adequately. Furthermore, it is still unresolved how to diagnose adequate cardiac     recovery.      Previous (pre)clinical studies showed that the calculation of the dynamic filling index may     provide a valuable parameter to monitor the drainable volume in patients supported by VAELS.     In addition, a case report showed that measurement of the dynamic filling index could     successfully be used to estimate cardiac recovery in a single patient supported by VA-ELS in     the ICU.      This study will assess the dynamic filling index as a representation for drainable volume and     cardiac recovery using standard recorded perfusion data in patients supported by VA-ELS   "
73286|NCT02326493|"     Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do     not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement     and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals to     the individual patient. However, the best strategy to optimize lead positioning and device     programming still remains to be established. Earlier work in our research group suggests that     the vector cardiogram (VCG) can be used to determine the optimal LV lead position and AV- and     VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG)     from the implanted pacing electrodes. Other studies have suggested that the best position for     the LV electrode is the region of latest electrical activation. The region of latest     electrical activation can be identified by measuring the electrical delay on the LV lead     (LVLED) during implantation. The objective of this study is to investigate whether D-VCG can     be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to     determine the optimal LV lead position.   "
73287|NCT02326480|"     Identify news genetic causes of different type of obesity (syndromic, familial or isolated     obesity) by highlighting new mutations or new implied genes   "
73288|NCT02326467|"     Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate (CHG)     a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated     infections (HAIs). CHG is believed to be superior to other forms of antiseptics because, when     it is applied to the skin surface, it leaves a lasting residue on the skin. CHG has been     shown to be well tolerated in patients 2 months of age and older. However there is limited     evidence to support the use of topically applied CHG in infants less than 2 months of age     because of potential safety concerns in this population. The purpose of this study will be to     describe the safety of bi-weekly CHG baths in a sample of Newborn Intensive Care Unit (NICU)     and pediatric Cardiac Intensive Care Unit (CICU) patients by measuring the incidence of skin     problems and CHG blood levels.   "
73289|NCT02326454|"     This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium)     activated by an intraurethrally placed drug-activating device. Two different light doses will     be tested against placebo groups in this 4-arm study.   "
73290|NCT02326441|"     The purpose of this study is to determine the safety and tolerability of the study drug     KX2-361 and to determine how much of the study drug enters the bloodstream, in patients with     advanced malignancies that have not responded to conventional therapies.   "
73291|NCT02326428|"     Ischemic stroke, i.e. irreversible damage of a part of the patient's brain, is caused by the     formation of blood clot in the major vessel which gives blood supply to a certain part of the     brain. At early time, within the first 4,5 hours, the conventional treatment is to try to     dissolve this blood clot with a medication (thrombolytic drug) which is administered to the     blood through the needle in the vein. If the clot still remains there, additional treatment     is possible - going directly to the clot via artery and taking it out with a special device.     Though this treatment is already used in many stroke centres, its benefit is not clearly     proven. The purpose of the present study is to evaluate the benefit and safety of this     additional treatment for the big stroke in patients fulfilling criteria for and receiving     conventional treatment within 4.5 hours of onset, as compared to conventional treatment only.   "
73292|NCT02326415|"     The aim of this study is to reduce the postoperative hospital stay, without increasing     morbidity and mortality postoperative, expressed in terms of rate of complications and     readmissions.   "
73293|NCT02326402|"     This study is intended to be a multicenter, prospective observation registry. By collecting     prospective descriptive data, provide insight into disease defining characteristics resulting     in the clinical decision to use TandemHeart for mechanical support and enhance knowledge of     best practice regarding clinical management, weaning and removal/exit strategies.   "
73294|NCT02326389|"     The purpose of this study is to evaluate the potential benefits of combining cognitive     remediation and exercise in improving cognitive functioning and response to psychiatric     rehabilitation.   "
73295|NCT02326376|"     A non-interventional, post authorization safety study to evaluate the safety of Kineret in     the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with     regard to serious infections, malignancies, injection site reactions, allergic reactions and     medication errors, including re-use of syringe.   "
73296|NCT02326363|"     This study will provide important information concerning the used of mindfulness-based     relapse prevention (MBRP) as a continuing care strategy for Veterans who have completed     primary treatment for a SUD. Most research is focused on the acute care of SUDs, but the risk     of relapse to substance use is highest during the period immediately following treatment and     attention to continuing care is critical. If this trial demonstrates that MBRP promotes     sustained abstinence and improved functional outcomes, this will provide a valuable treatment     to facilitate rehabilitation and recovery for Veterans with SUDs.   "
73309|NCT02326194|"     Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14     outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious     outbreak was considered to be a new epidemic strain, with GP homology of the gene was only     97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine     was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry     products which could be stored at 4℃.      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical     trial. This study will determine the safety and side-effect profile, and immunogenicity of an     investigational Ad5-EBOV vaccine.   "
73297|NCT02326350|"     Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of     fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive     Care Units and is associated with a high mortality and a high morbidity in those who survive.     There is a large economic burden with direct healthcare costs, but also indirectly due to the     impact on the carer and patient through their inability to return to full time employment.     There is little evidence for effective drug (pharmacological) treatment for ARDS. Blood cells     called platelets have increasingly been recognized to play a key role in the development of     ARDS. There is increasing information that aspirin, a drug which is widely used to treat     heart disease, might be important in treating ARDS. We plan to test if aspirin will help in     the treatment of ARDS. To do this we will divide patients suffering from ARDS into two     groups, one of which will get aspirin and the other a harmless dummy (or placebo) tablet who     will then be followed up to determine if lung function improves. If effective this may lead     to further research to determine if aspirin is effective in patients with ARDS. This project     will also provide new information about mechanisms in the development of ARDS leading,     potentially, to other new treatments.   "
73298|NCT02326337|"     The purpose of this study is to evaluate the efficacy, safety and economical benefits of     Cyclical Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot     ulcers. All subjects will wear a standardized off-loading device and use advanced moist wound     therapy (AMWT) dressings. Half the subjects will use the TWO2 device, while the other half     will use a sham device.   "
73299|NCT02326324|"     This study aims to investigate the diagnostic and prognostic utility of cardiovascular     magnetic resonance (CMR) imaging in a large cohort of unselected patients who are undergoing     CMR scanning for clinical indications (i.e. suspected/confirmed cardiovascular disease). CMR     indices will be related to the presence and severity of cardiovascular disease and other     markers of cardiovascular and health status.   "
73300|NCT02326311|"     In this phase III clinical randomized study, fixed intermittent administration (one month     ON/one month OFF) of TKIs (control arm), will be compared with progressive intermittent     administration (one month ON/one month OFF for the 1st year; one month ON/two months OFF for     the 2nd year; one month ON/three months OFF for the 3rd year) (experimental arm). Imatinib     (Glivec), or Nilotinib (Tasigna), or Dasatinib (Sprycel) will be given intermittently at the     same daily dose that was given daily at the time of the enrollment . Chronic phase Ph+ CML     patients in stable major molecular response (MR3.0 or MR4.0) after ≥2 years of standard     treatment with IM, NIL, or DAS will be randomized 1:1 to receive fixed INTERIM or     progressive INTERIM. Randomization will be stratified by type of TKI (IM, NIL, or DAS,) and     by depth of molecular response (MR3.0or MR4.0). The study is aimed to evaluate if a     progressive increase of intermittent treatment discontinuation until 3 months is able to     improve QoL outcomes with respect to fixed intermittent administration of TKIs (control     arm) and to maintain MR3.0 / MR4.0 molecular response. Patients' self reported EORTC QLQ-C30     outcome measure will be assessed throughout the three years follow up period. The QoL results     in this trial will be presented in accordance with high methodological quality criteria for     documenting patient-reported outcomes (PRO) data in RCTs, including the CONSORT PRO     recommendations. Furthermore, the study could give additional clinical and biological     information to optimize TKIs therapy in elderly.   "
73301|NCT02326298|"     The purpose of this study is to investigate the efficacy and safety of two dose levels of     certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when     administered every 2 weeks.   "
73302|NCT02326285|"     This study is designed as a single arm, un-controlled, open-label, multi-center hypothesis     generating two-stage phase II trial. It is based on the assumption that the proposed     treatment scheme doubles the rate of pathologic complete remission in Mutated epidermal     growth factor receptor (EGFRmt) + NSCLC patients compared to historical control data from     standard treatments.      Patients with NSCLC and activating EGFR mutation in stages II, IIIA and IIIB eligible for     induction therapy with docetaxel and cisplatin and gefitinib      Patients will be treated for 12 days with gefitinib 250 mg/day p.o. (d -12 to -1) and induced     with chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib     250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3). Surgery is planned in the 4th week     after d1 of the last cycle.   "
73303|NCT02326272|"     The purpose of this study is to investigate the efficacy and safety of two dose levels of     certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.   "
73304|NCT02326259|"     The investigators are doing this research for two reasons. The first is to see how the retina     (back of your eye) changes when your blood sugar is treated with medication for the first     time. This will help us better understand the progression of a condition known as Diabetic     Retinopathy. The second reason is to provide diabetic blood samples, which will possibly help     identify biomarkers for diabetic retinopathy. Biomarkers are things that indicate the     presence of a specific condition, and indicate a higher likelihood of developing that     condition.   "
73305|NCT02326246|"     The purpose of this study is to investigate the hypothesis, that mMRI provides a more     accurate and secure interpretation of the aggressiveness of prostate cancer initially/before     mMRI defined as low risk. In doing so we will investigate and assess the affect of mMRI on     gleason score upgrade, risk classification upgrade and changes in treatment strategy (active     surveillance vs. operation).   "
73306|NCT02326233|"     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the     pre-filled pen and pre-filled syringe of SB5 in healthy subjects.   "
73307|NCT02326220|"     This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the     effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments     in patients with HeFH undergoing LDL apheresis therapy.   "
73308|NCT02326207|"     The purpose of this study is to determine incidence of ventilator-associated pneumonia     compared between weekly and no routine ventilator circuit changes in neonatal intensive care     unit   "
73372|NCT02325362|"     The purpose of this study is to demonstrate that Miglustat restores the function of the     cystic fibrosis transmembrane conductance regulator (CFTR) in adult patients with cystic     fibrosis homozygous for the F508del mutation.   "
74861|NCT02305888|"     The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1%     for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and     trunk/extremities, respectively.   "
73311|NCT02326168|"     Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG     immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG     vaccination, patients will then receive standard strength BCG intravesical therapy once a     week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2     hours. While the BCG is retained in the bladder the patient should be repositioned every 30     minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy     every 3 months following most recent TURBT. Study duration last approximately 6 months.   "
73312|NCT02326155|"     An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™ in     patients with Crohn's disease (CD) or Ulcerative Colitis (UC)   "
73313|NCT02326142|"     The primary objective of this study is to assess the efficacy of a single dose of OBE001, an     oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to     placebo.   "
73314|NCT02326129|"     The investigators wants to determine if 11β-HSD1 activity will be positively associated, and     5α-reductase activity negatively associated, with (a) degree of insulin resistance defined by     the homeostatic model assessment of insulin resistance index (HOMA-IR) and (b) worsening     glycemic control defined by higher HbA1c and impaired fasting glucose in a group of obese     children and young adults with or without type 2 diabetes compared to lean children and young     adults without diabetes. The investigators also want to identify key metabolic signatures     associated with diabetes using metabolomic profiling.   "
73315|NCT02326116|"     The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed prior     to anterior cervical spine surgery can result in a decreased rate of dysphagia.   "
73316|NCT02326103|"     The study is aimed to evaluate the additional role of ciprofloxacin therapy in severe     alcoholic hepatitis combined to prednisolone therapy in an open-label placebo controlled     manner.   "
73317|NCT02326090|"     The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA     Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.   "
73318|NCT02326077|"     Objectives:        -  Evaluation of the correlation between the sonographic parameter and clinical findings          (e.g. digital examination) in any cephalic (not only occipital anterior) position        -  Examination of the relationship between various sonographic parameters        -  Determination of intraobserver and interobserver variation in obtaining the sonographic          measurements        -  Analysis of the temporal variation of the different sonographic measurements in normal          spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior          versus those with persistent occiput posterior        -  Establishment of a sonopartogram that should replace in an objective way Friedmann        -  Establishment of cut-off values that may help clinicians to choose between vaginal          operative delivery or caesarean section        -  Another interesting aspect of intrapartum transperineal ultrasound imaging is whether          there is a psychological benefit to the patient in being able to follow on the          ultrasound screen how fetal head descent and position are being assessed objectively.   "
73319|NCT02326064|"     Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these     cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main     difficulties. The first is to establish an early diagnosis. The second is to differentiate a     benign tumor, a malignant tumor.      To date, there is only one biological tumor marker routinely performed before an ovarian     cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and     show a sensitivity and specificity unsatisfactory in view of the severity of the disease.      The principal investigator therefore propose to evaluate a new tumor marker, as well as its     use in algorithms to help differentiate benign from malignant tumors, and allow earlier     diagnosis in cases of ovarian cancer.   "
73320|NCT02326051|"     Evaluation of the effect of altering the timing of initiation of low molecular weight heparin     (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)   "
73321|NCT02326038|"     Traditionally, memory impairments in the elderly population are treated using cholinesterase     inhibitors, although impairments remain after treatment. Dopamine (DA) is also involved in     cognition and is especially of interest in healthy ageing because of the role in processing     speed and cognitive control. To what extent dopamine treatment improves memory and attention     in older impaired individuals is unknown. However, such an effect is conceivable because of     the close relationship between memory and attention in aging and since improved processing     speed and cognitive control may lead to improved memory.      The investigators aim to examine, in the impaired older population, whether a treatment using     methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention and memory.     The study will be conducted according to a cross-sectional, double-blind, placebo-controlled,     2-way cross-over design. 20 male and female patients with Mild Cognitive Impairment (MCI),     amnestic type, aged above 60 years of age; 20 male and female patients with MCI, non-amnestic     type, will be recruited from the Orbis Medical Centre. Participants will be treated once with     20 mg methylphenidate (MPH) and once with placebo. All medications will be administered     orally with a capsule. The treatment order will be established by counterbalancing.   "
73322|NCT02326025|"     The purpose of this study is to assess how the body handles olaratumab when it is given with     another drug called doxorubicin.      The safety and tolerability of these drugs will be studied. Each participant will complete     two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive     olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab     alone until discontinuation criteria are met.      Screening is required within 21 days prior to first dose.      Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab     when given with doxorubicin.      Participants may only enroll in one part.   "
73323|NCT02326012|"     The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy     for Adolescents (ERITA) who self-harm.   "
73324|NCT02325999|"     The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine     with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve     Disease-free survival ？   "
78988|NCT02251951|"     The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II     trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and     gastro-esophageal junction   "
73326|NCT02325973|"     The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR)     can be considered a prognostic predictor for the occurrence of events at one year of follow     up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial     Infarction (STEMI) patients.      Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular     death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation     or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the     study.   "
73327|NCT02325960|"     This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group     Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2     Diabetes Patients Inadequately Controlled With Metformin Monotherapy.   "
73328|NCT02325947|"     The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton     technology based on EEG patterns recognition matching to motor imagery in post-stroke     patients with hand paresis.   "
73329|NCT02325934|"     Elvitegravir is an HIV-1 integrase inhibitor which is marketed in a fixed dose combination     tablet with cobicistat, tenofovir and emtricitabine (Stribild®, referred to as STB). For     patients with swallowing difficulties, administration of whole tablets can be problematic and     tablets are cut or crushed to ease administration. In addition if HIV patients develop     opportunistic infections, patients can become severely ill and may end up on the intensive     care. Patients at the intensive care might not be able to swallow medication. Therefore it is     useful to know if it is possible to administer STB through a different route, like a feeding     tube. If STB can be crushed or dissolved and given through a catheter it is also useful to     know if it can be given with drip feed.      Currently there is no information about crushing STB tablets. Crushing STB tablets into a     liquid medium has not been studied and is not recommended according to the SPC text.     Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets     can lead to altered pharmacokinetics of drugs.      It is important to know whether pharmacokinetics are influenced by crushing of tablets as low     concentrations are associated with virologic failure. Therefore higher doses might be needed.     In addition, higher Cmax and/or exposure can lead to toxicity. As a result therapeutic drug     monitoring is advised, or crushing the drug is a contra-indication based on the available     data.      It has been shown that simultaneous oral ingestion of antacids and elvitegravir gives a     decrease in Cmax and AUC of elvitegravir. This interaction is not shown for co-ingestion with     omeprazole. Which makes it unlikely that this interaction is caused by a pH-lowering effect     influencing the absorption of elvitegravir. It is probably a local gastrointestinal     complexation phenomenon, similar to what has been observed with other HIV integrase     inhibitors. A possible pharmacokinetic interaction between elvitegravir and complexation     formers may be expected. Especially considering the active binding sites of elvitegravir     which bind magnesium metal ion cofactors. Although there is data that STB can be ingested     with a protein rich drink, it is unclear if foods or liquids containing high amounts of     magnesium or other cations can cause this same interaction.      Therefore this study will be conducted to investigate whether crushed and suspended STB and     crushed and suspended STB with drip feed are bioe-quivalent to taking STB as a whole.   "
73330|NCT02325921|"     Diagnostic imaging for renal masses of unknown nature using conventional imaging modalities     such as 3 phase contrast-enhanced computed tomography (CT) is not always conclusive. After     (partial) nephrectomy, 10-20 % of the resected tumors show benign histology which could not     be identified on diagnostic imaging. With improved imaging techniques available, leading to     improvements in characterisation of renal tumors, the number of unnecessary resections may be     reduced. The objective of this study is to evaluate the diagnostic performance of diffusion     weighted magnetic resonance imaging (DW-MRl) in assessing the nature of renal masses,     including the use of diffusion tensor imaging (DTI).Therefore patients >18 years of age     scheduled for undergoing (partial) tumor nephrectomy will undergo one additional MRI     examination.   "
73331|NCT02325908|"     The purpose of this study is to learn how the amount of fluid in the body of a hemodialysis     patient affects him or her. Body hydration is the amount of fluid in the human body and known     to be related to blood pressure. Too much fluid can lead to high blood pressure which can     cause heart problems and eventually lead to death. Bioimpedance Spectroscopy (BIS) is a     method that may be used to measure body hydration. This can be applied in the whole body,     arm, trunk, calf, and leg. It is a non-invasive and inexpensive method and no known risk. BIS     measurements can be used to assess optimal hydration status which is defined as a patient's     ideal weight after completing a dialysis treatment. The investigators hypothesize that your     target weight may be better estimated by the BIS. The results of this study, in particular     the continuous measurement of calf hydration which is associated with the hydration of the     whole body, may provide useful information about physiologic (healthy) body hydration. It     may possibly help to improve treatment procedures for patients in the future. The Renal     Research Institute plans to enroll 100 chronic hemodialysis patients and 200 healthy controls     in this study.   "
73332|NCT02325895|"     The objective of the investigators current study was to examine whether 50 g dried plum would     be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal     women.   "
73333|NCT02325882|"     The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based     intravenous patient controlled analgesia (PCA) improves postoperative pain compared with     conventional thoracic epidural and intravenous patient controlled analgesia after radical     open gastrectomy.   "
73334|NCT02325869|"     DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance     of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.   "
73335|NCT02325856|"     A reasonable and simple algorithm was used to guide the dry weight determination with Body     Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze the     feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid management     on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis     (MHD) patients.   "
73336|NCT02325843|"     Ocular chemical burn is one of the cause of vision loss in our country, and there are no     satisfactory treatment. Human bone marrow mesenchymal stem cells (MSC) have the biological     characteristics of self-renewal, immune regulation, multidirectional differentiation and     tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC     can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access     the efficacy and safety of mesenchymal stem cell in the treatment of corneal burn in human.   "
73337|NCT02325830|"     The objective of this prospective, multi-center, randomized, double-blind trial is to assess     the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral     regurgitation (FMR) associated with heart failure, compared to a randomized Control group     which is medically managed according to heart failure guidelines.   "
73338|NCT02325817|"     The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon     in the treatment of patients with bifurcation lesions of coronary artery.   "
73339|NCT02325804|"     The main purpose of this study is to assess metabolic effects (decreased amount of body fat     content, insulin sensitivity and lipid profile improvement) of weight loss intervention based     on specific life style counseling (low calorie metabolic stairs diet and circuit-based     exercise in a comparison to conventional diet and exercise. The main hypothesis is that more     significant beneficial metabolic effects will have specific life style counseling effect than     conventional diet and exercise. The main purpose of this study is to assess above mentioned     metabolic changes before and after 6-8 weeks of weight loss intervention.      The investigators will also study the following:        1. The impact of life style counseling induced weight and/or fat loss on physical fitness        2. The impact of life style counseling induced weight and/or fat loss on metabolic          parameters (e.g. insulin sensitivity, lipid profile, ect.)   "
73340|NCT02325791|"     The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and     immunogenicity of REGN2222 in infants born no more than 35 wGA (weeks gestational age), who     are no more than 6 months of age at the time of enrollment in their respective geographic     location. In order to optimize the potential benefit in this vulnerable population, we will     conduct this study during the RSV season using dosing regimens that are expected to be     effective.   "
73341|NCT02325778|"     This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation     results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in     patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic     drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.   "
73342|NCT02325765|"     In this study，the investigators want to determine the corelation between circulating     nuclearsome and the development of SIRS occured after congenital cardiac surgery, including     the serverity of organ damage and inflamation.   "
73343|NCT02325752|"     The investigators conducted an open randomized control study of patients who received the     transitional care program versus patients who received usual care at the Singapore General     Hospital from Aug 2011 to Sept 2012.   "
73344|NCT02325739|"     Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401     as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and     as single agent in patients with other solid malignancies.   "
73345|NCT02325726|"     Postoperative acute renal failure is a frequent complication after cardiac surgery. The     current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a     significant kidney assault and prevent an organic dysfunction leading to cortical tubular     necrosis.      Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as     the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These     urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the     'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought     noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These     markers, ultrasonographic and biologic, have the advantage of being easy to perform,     accessible and seem to have both high sensitivity and specificity to predict AKI promptly     after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests     to guide clinicians in determining rapidly whether a patient will develop AKI. However, so     far, no study has compared these markers yet.      Therefore, the aim of this prospective observational study will be to compare the     effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac     surgery. The secondary outcome will be to determine the threshold of these markers from which     patients will be likely to develop AKI   "
73346|NCT02325713|"     This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The     purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible     Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the current marketed     praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers.   "
73347|NCT02325700|"     This prospective study was designed to analyse the postoperative and long-term outcomes of     total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease     (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using     a propensity analysis model.   "
73348|NCT02325687|"     Obstructive sleep apnea (OSA) is common and is a risk factor for postoperative complications,     including respiratory and cardiac events and delirium. Despite this risk, however, there are     currently no accepted biomarkers that can predict poor outcomes, making it unclear to see     which patients will have complications after surgery, and who might need prolonged monitoring     or an extended hospital stay. An improved understanding of the pathophysiology of OSA is     required to identify potential biomarkers for outcomes after surgery, as well as to develop     new treatments. The aim of this pilot study is to identify serum and cerebrospinal (CSF)     biomarkers associated with obstructive sleep apnea (OSA). The presence of cytokines and     neurotrophins will be determined and quantified in both patients with OSA and in controls.     The CSF samples will additionally be analyzed by proteomic methods to identify potential     biomarkers with significantly different levels present in patients with and without OSA. The     working hypothesis is that OSA patients who are non-CPAP-compliant will have higher levels of     circulating cytokines and lower levels of circulating neurotrophins in serum and CSF,     compared to patients who are CPAP-compliant and/or controls.   "
73349|NCT02325674|"     Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated     with Metreleptin   "
73350|NCT02325661|"     The objective of this study is to translate the AKQoL-questionnaire which measures the     quality of life of patients with actinic keratosis into German and to validate it for the     Swiss population.      By using the technique of cognitive interviewing the investigators are focussing on the     patients' understanding of the questions. The first session of cognitive interviews will     show, where there is need for improvement in terms of misinterpreted phrases or vaguely     worded questions. The goal is to rephrase the questions according to the feedback of the     patients. The revised version will then be presented to a new population.   "
73395|NCT02325063|"     The primary objective of this study is to compare the evolution of pain profiles among     patients suffering from lateral epicondyalgia (tennis elbow) following three types of     treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid     injection.   "
73351|NCT02325648|"     The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic     intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a     significantly high survival rate has been demonstrated by several studies. It is widely known     that HIPEC entails severe physiological changes and precautions during anesthesia. However,     very few studies have systematically outlined and organized these changes for each system,     and most existing studies only report retrospective data or are limited to gynecological     surgeries. Therefore, the present researchers planned a prospective observational study to     determine the physiological changes that occur in patients during HIPEC cytoreductive     surgeries performed in the colon and rectal surgery department of the investigators hospital.     The investigators planned to monitor the patients' body temperature, metabolism,     cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the     anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC     cytoreductive surgeries.   "
73352|NCT02325635|"     Randomized prospective multi-site validation study.   "
73353|NCT02325622|"     The liver plays a crucial role in physiological glycemic control through its involvement in     several glucose metabolism processes, including glycogenogenesis and glycogenolysis. Liver     diseases result in impaired glucose metabolism due to hepatocyte dysfunction, termed as     hepatogenous diabetes. Abnormal glucose metabolism is found in over 90% of patients with     liver cirrhosis. and clinically significant diabetes is known to occur in 30% to 70% of the     patients.      A cohort study of cirrhotic patients with hepatogenous diabetes reported a relatively low     diabetic complication rate, and the majority of mortality causes were complications related     to liver cirrhosis; furthermore, mortality rate due to diabetic complications were reported     to be low. Nonetheless, the average survival rate following the diagnosis of liver cirrhosis     is rising due to increasing early detection rate and improvements in treatment modalities,     and such rise in survival is expected to result in increased prevalence of hepatogenous     diabetes and its complications. Therefore, it is necessary to formulate an accurate diagnosis     of hepatogenous and to provide appropriate treatment.      Analyses of the Diabetes Control and Complications Trial (DCCT) demonstrated an association     between glycated hemoglobin (HbA1c) and mean plasma glucose concentration in diabetic     patients, and currently, HbA1c is being employed as an appropriate marker in diagnosing     diabetes mellitus and in monitoring the control of mean blood glucose.      The association between mean plasma glucose concentration and HbA1c in cirrhotic patients has     not been clearly established as of yet; however, HbA1c in cirrhotic patients is expected to     be influenced by various factors resulted by liver cirrhosis and splenomegaly, including     rapid erythrocyte turnover rate and other glycation processes.      Therefore, HbA1c may not be an appropriate indicator in the diagnosis of hepatogenous     diabetes or the monitoring of glycemic control; however, no systemic study on this issue has     been performed so far. Therefore, the investigators are aiming to investigate the association     between mean plasma glucose concentration and HbA1c in patients with compensated or     decompensated liver cirrhosis who also have hepatogenous diabetes.   "
73354|NCT02325596|"     This study aimed to evaluate the upstream events of Th17/Treg imbalance in CRS and their     immune regulatory factors. Then the investigators aimed to explore the regulatory role of     miRNA on DC-Th axis and its dysfunction in the pathogenesis of CRS, in order to determine the     miRNA expression profile in CRS and clarify the role of miRNA in the pathogenesis of CRS by     regulating the DC-Th axis.   "
73355|NCT02325583|"     Newborn often sedated during MRI but sedation itself creates adverse events and management is     more challenging in the MR environment. The investigators describe the investigators initial     experience with oral 30% glucose administration through a pacifier during MRI for imaging of     newborns. Using this technique, majority of newborns can complete MRI examination without the     need for sedation and also offers the availability of administering sedatives to unsuccessful     patients.   "
73356|NCT02325570|"     Multicenter, prospective, interventional open case series study using a randomized     split-mouth design in moderate to severe chronic periodontitis patients having half-mouth     treated with the KLOX BioPhotonic OraLum gel with a LED curing lamp as an adjunct to     conventional non-surgical periodontal treatment (SRP) versus SRP alone in the second     (control) half-mouth.   "
73357|NCT02325557|"     A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a     combination of ADXS31-142 with Pembrolizumab (MK-3475) in patients with metastatic     castration-resistant prostate cancer. Part A will be dose-determining of ADXS31-142     monotherapy. Part B will be dose-determining of ADXS31-142 and Pembrolizumad (MK-3475) in     combination. Part B expansion will treat additional patients with the recommended dose from     Part B.   "
73358|NCT02325544|"     The study will test the hypothesis that Cognitive Behavioural Therapy plus Standardised     Medical Care (SMC) will have greater clinical and cost effectiveness than SMC alone in     treating adult patients with dissociative seizures which had not initially ceased after     diagnosis.      About 12-20% of patients who attend neurology or specialist epilepsy clinics because of     seizures do not in fact have epilepsy. Most of these people have what are referred to as     dissociative (non-epileptic) seizures (DS). This means that they have episodes that resemble     epileptic seizures but which have no medical reason for their occurrence and instead are due     to psychological factors. In younger adults DS are about four times more common in women than     men. A high percentage of these people will have other psychological or psychiatric problems     and may have other medically unexplained symptoms. It is generally thought that people with     DS will benefit from psychological treatments. However, studies on this have been small or     have not compared the psychological therapy with the treatment people normally receive     (standardised medical care). There is some evidence that cognitive behavioural therapy (CBT),     which is a widely accepted talking therapy that focuses on the person's thoughts, emotions     and behaviour, as well as considering the physical reactions and sensations that may occur in     people's bodies, may lead to a reduction in how often people have DS. The investigators have     previously developed a CBT package for people with DS. In a relatively small study by our     group, published in 2010, people receiving CBT overall showed greater reduction in how often     they had their DS. The investigators are now conducting a larger study, across several     different hospitals, to obtain more definite results about the effectiveness of our CBT     approach for DS.      The investigators aim to invite ~ 500 adult patients with DS (but without current active     epilepsy), who have been given their diagnosis by a neurologist or specialist in epilepsy, to     take part in their study. Up to 698 might be invited if insufficient patients are progressing     to the RCT.      The investigators will collect initial information about these people and ask them to keep a     record of how often they have their DS following diagnosis. Three months after the diagnosis,     those who have agreed to take part in the study will be seen by a psychiatrist, who will     undertake a psychiatric assessment and ask them about factors which may have led to the     development of their DS. Patients who have continued to have DS in the previous 8 weeks and     who meet other eligibility criteria and are willing to take part in the trial, will be     randomly allocated to standardised medical care or CBT (plus standardised medical care) as     further treatment for their seizures. These people will be asked to continue to complete     seizure diaries and questionnaires, provide regular seizure frequency data following receipt     of DS diagnosis and will need to be willing to attend weekly/fortnightly sessions if     allocated to CBT. The investigators initially aim to randomise 298 people (149 to each study     arm) although now allow for up to 356 to account for loss to follow-up.   "
73359|NCT02325531|"     The investigators propose to compare the effectiveness of 3 strategies (low, medium, high     intensity) at supporting CHCs' implementation of the ALL Initiative (an intervention shown to     reduce patients' cardiovascular disease (CVD) event risk), through a cluster-randomized     trial.   "
73360|NCT02325518|"     The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT®     Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular     hypertension.   "
73361|NCT02325505|"     Tuberous Sclerosis Complex (TSC) is a multisystemic autosomal dominant disease that is     characterized by the development of benign neoplasms in brain, kidney, lung, skin and heart.     TSC is caused by mutations in TSC1 and/or TSC2 genes, which encode, respectively, hamartin     and tuberin, that are involved in the regulation of cell proliferation, cell cycle and     protein synthesis. Most patients exhibit dermatological, renal, neurological and pulmonary     (lymphangioleiomyomatosis, LAM) manifestations. Neurological involvement include subependymal     nodules, subependymal giant cell astrocytomas and cortical tubers. LAM is characterized by     the proliferation of LAM cells around the airways, blood vessels and lymphatics, which result     in vascular and airway obstruction and cyst formation. The most frequent TSC manifestation in     the kidney is the development of angiomyolipomas (AML). Dermatologic lesions represent the     most common manifestations of TSC, mainly hypomelanotic macules and facial angiofibromas. The     most significant functional implication of the tuberin-hamartin complex is its regulatory     role upon the mammalian target of rapamycin (mTOR) pathway. Mutations in TSC1 or TSC2 lead to     increased mTOR activity and favor tumor development and growth. All lesions associated with     TSC, sporadic LAM and sporadic AML share a common molecular pathogenesis, based on TSC1/TSC2     mutations and mTOR hyperactivity. Up to date, TSC patients have been followed in separated     medical services in our institution, according to their predominant phenotype. The current     knowledge, however, suggest that the ideal follow up of such patients should be conducted in     an integrated fashion among the specialties associated with the main disease manifestations.     Experts in TSC from each of these areas have recently created a TSC/LAM/AML integrated     program in the University of São Paulo Medical Center, and his project will be initiated with     the generation of an integrated TSC/LAM/AML registry, which intends not only to clinically     characterize this patient population but also to document the employed treatment modalities.     Once this first goal is achieved, clinical trials are planned to be performed. The central     aim of this observational study is to clinically characterize the TSC/LAM/AML subject     population followed and referred to the University of São Paulo Medical Center. Specific     aims: To characterize the pulmonary, the neurological, the renal and the dermatologic     phenotypes of this patient population.   "
73362|NCT02325492|"     This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed     to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age,     with newly formed cholesterol gallstones in their gallbladder following bariatric surgery     confirmed by gallbladder ultrasound ..   "
73396|NCT02325050|"     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and     Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult     participants.   "
73363|NCT02325479|"     Heparin also has the ability to bind with and modulate a wide variety of proteins, which can     influence a number of physiological processes involved in implantation & trophoblastic     development. These processes include adhesion of the blastocyst to the endometrial surface &     trophoblastic differentiation & invasion.      A recent Cochrane review hinted towards research to study the possible effects of the local     (uterine), & NOT SYSTEMIC application of heparin during Assisted reproductive technology     (ART). Based on the above evidence the investigators hypothesize that low molecular weight     heparin given intrauterine at mock embryo transfer after oocyte pick up will help improve     pregnancy rates in patients undergoing ART.   "
73364|NCT02325466|"     The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be superior     to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week     treatment period. Study participants will be randomized into 3 groups, and each group will     receive each of 3 treatments in the cross-over study. At the end of each individual 4 week     treatment period the investigators will determine whether there are differences in low and     high shear rate dependent viscosity and investigate the effect of the treatment on peripheral     arterial blood flow using pulse volume recordings, ankle brachial index and toe pressures.     Subjects will be eligible if they have ankle-brachial index less than or equal to 0.85, or if     a patient's blood vessels are calcified, patients will have toe-brachial index less than or     equal to 0.6 performed using continuous-wave Doppler.   "
73365|NCT02325453|"     Gastric cancer represents a great challenge for health care providers and requires a     multidisciplinary context in which surgery plays a main role.      Minimally invasive surgery has been progressively developed, first with the advent of     laparoscopy and more recently with the spread of robotic systems, but a number of issues are     currently being debated, including the limitations in performing effective extended lymph     node dissections and, in this context, the real advantages of using the robotic systems, the     possible role for the Advanced Gastric Cancer, the reproducibility of completely     intracorporeal techniques and the oncological results achievable during follow-up.      A multicenter study with a large number of patients is now needed to further investigate the     safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy     and the open approach.   "
73366|NCT02325440|"     A trial in patients with relapsing remitting multiple sclerosis (RRMS)      Main objectives:        -  To evaluate changes in the reconstitution of immune surveillance over time upon          switching from natalizumab to fingolimod assessed by a change in the expression of          CD49d.        -  To evaluate changes in the migratory capacity of immune cells/peripheral blood          mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro          model of the blood-brain-barrier (BBB).        -  To evaluate changes in paraclinical disease activity over time upon switching from          natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI).        -  To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to          fingolimod.   "
73367|NCT02325427|"     This study is to investigate changes in brain activities in acute stroke patients , and to     correlate findings with clinical outcome measures. Another aim of the study is to investigate     whether transcranial direct current stimulation (tDCS) could improve motor function in     subjects with poor brain activity after stroke. The brain activity will be measured by single     and paired pulse TMS (transcranial magnetic stimulation). The study hypothesizes that:        1. The neural mechanisms employed in patients who have different response to TMS          stimulation are different. It is hypothesized that patients with no response upon TMS          stimulation might have poorer motor function outcome, compared with patients with          response upon TMS stimulation.        2. The result of clinical outcome measures is related with TMS measurement.        3. tDCS intervention is beneficial to subjects with poor brain activity. Clinical outcome          measures will include a battery of upper limb motor tests such as upper extremity          component of the Fugl-Meyer Assessment, Modified Ashworth scale for spasticity, box and          block test, and manual muscle testing. Clinical outcome and TMS measurement will be          assessed at within 2 weeks, 4-6 weeks and at 6 months post-stroke.   "
73368|NCT02325414|"     The overall objective of this study is to define an effective therapeutic approach, using     currently available medication, to prevent or mitigate the loss of bone mass and bone     strength that occurs after acute spinal cord injury.   "
73369|NCT02325401|"     The purpose of this research study is to test the safety of adding metformin to standard of     care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments     and radiation for 7 weeks.      Metformin is a medication that is currently used to treat diabetes. Increasing amounts of     metformin will be given to groups of patients already receiving normal treatment for their     cancer to see if metformin causes any good effects by killing your cancer or bad effects     (side effects).   "
73370|NCT02325388|"     Pressure ulcers are prevalent conditions that result in substantial financial costs to the     healthcare system as well as significant distress to affected patients and their families.     This study is a parallel two-group randomized controlled trial that aims to study how the use     of a pressure sensing device with continuous visual feedback of pressure imaging may     potentially decrease the interface pressure of patients who are at risk of pressure ulcers in     an acute hospital setting.   "
73371|NCT02325375|"     Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive muscle weakness     leading to severe disability and eventually death.Since the diagnosis relies on clinical     features and electromyographic abnormalities, which may occur rather late in the disease     course, there is a need to identify diagnostic tests that can confirm or exclude the     diagnosis of ALS in the earlier phase of the disease.      More recently, there are studies suggesting neuroinflammation to play a role for the     development of ALS. Cluster of differentiation 163 is found to be up regulated in a large     range of inflammatory diseases.      At the investigators lab, pilot data (Kallestrup M et al, unpublished data) has shown     promising results. There was an increased level of cluster of differentiation 163 (sCD163) in     cerebrospinal fluid in 7 patients with ALS compared with controls.      The purpose of the investigators study is to define the concentration of sCD163 in the     cerebrospinal fluid and serum in patients with ALS compared with controls (patients with     unspecified neurological symptoms). Furthermore, the investigators will define the     concentrations of protein, glucose, immunoglobulin G index and other factors in the spinal     fluid.   "
73373|NCT02325349|"     The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in     PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with     antiangiogenic effect.      The predictive value of this approach will be determined by independent assessors on basis of     data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG     PET/CT, clinical, endoscopic and histological findings.   "
73374|NCT02325336|"     Serious medication administration errors are common in hospitals. Various interventions were     developed to help prevention of such errors such as bar-code technology. Investigators aimed     to study the effect of bar-code-assisted medication administration (BCMA) system on the rate     of medication errors in two hospitals.      They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris,     France. Each unit will be randomized in either the control group or the intervention group     using the bar-code system to help drug administration. The observation method will be used to     evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted. Nurses     of the unit will be randomized to determine who will be observed during the administration     rounds.      Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv     Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators     estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative     reduction of 45% of error rate.   "
73375|NCT02325323|"     This prospective cohort study aims to assess the incidence of gastric cancer in patients with     intestinal metaplasia in body of stomach or angular incisure.      As secondary objectives, among the patients included in the cohort, the study will:        -  assess the incidence of low grade dysplasia,        -  assess the incidence of high grade dysplasia in patients with low grade dysplasia,        -  identify risk factors of progression to dysplasia and gastric cancer.   "
73376|NCT02325310|"     In order to assess the safety of breastfed infants after their mother's postpartum     immunization with a combined measles-mumps-rubella (MMR) vaccine, the purpose of this study     is to investigate whether measles vaccine strain is excreted in breast milk of breastfeeding     women with negative rubella and measles serologies.   "
73377|NCT02325297|"     After the death of a patient in the hyper-technical context of intensive care, his relatives     are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic     stress and complicated grief. The first results of a qualitative study Famiréa current     (CAESAR) support the idea that the bereaved relatives suffer from persistent     misunderstandings and a feeling of abandonment of the resuscitation team. Many families     suggest the need for contact with the team after the patient's death. The letter of     condolence received by some families allowed them to feel recognized in their pain     resuscitation teams. This has led us to ask the question of post-death monitoring and     interest to send to bereaved relatives a letter of condolence, as recommended by the American     consensus conference in 2004 on good palliative care. This strategy would allow the     recognition of both close to the pain but also the strong bond that united the resuscitation     team. The hypothesis of the study is that the post-death followed in the form of a letter of     condolence sent by the intensive care physician who was in charge of the patient, could     reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and     reduce the rate of complicated grief.      Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who     did not receive a letter of condolence and a group that received a letter of condolence 15     days after the death.   "
73378|NCT02325284|"     The development of tools for assessment and management of pain in newborns and children is a     high priority and represents a significant unmet need. The inadequate treatment of pain and     the overuse of analgesics can cause harmful consequences for neonates, infants, and children.     To accomplish successful pain management in children one must first objectively assess pain.     Thus, to address these critical issues with pain management, the Human Algometer and methods     are under development by Drs. Julia Finkel and Zena Quezado, Pain Medicine Program (SZI) at     Children's National Medical Center.   "
73379|NCT02325271|"     The study evaluates the intra-individual variability of VEGF levels over a period of 6 months     as well as the circadian variation of VEGF levels, both under standardized conditions in     patients with type 2 diabetes without DME and matched subjects with normal glucose tolerance     (NGT). Secondary objectives of the study are to evaluate the relationship of individual     VEGF-levels to biomarkers of inflammation, HbA1c and major cardiovascular risk factors.   "
73380|NCT02325258|"     The aim of the present study was to evaluate the ability of health-care professionals in     addressing sepsis, and the impact of a telephone call upon receival of blood cultures in the     clinical microbiology department, from a clinical microbiologist, in the early management of     sepsis.   "
73381|NCT02325245|"     The purpose of this study is to investigate the effects of metformin to prevent frailty in     pre-frail non-diabetic elderly. Several outcomes measured in this study are frailty status,     quality of life, handgrip strength, gait speed, and serum myostatin levels.      We hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.   "
73382|NCT02325232|"     Celiac disease (CD) is the most common chronic autoimmune enteropathy in Western Countries     with an estimated prevalence ranging from 1:100 to 1:200. It is usually characterized by a     benign course with clinical and histological remission, provided that a strict gluten-free     diet (GFD) is followed by patients. Less frequently, CD can be characterized by a complicated     course, when facing with a refractory disease (RCD) or with malignancies of the     gastrointestinal (GI) tract, namely lymphoma and adenocarcinoma of the small bowel (SB).     Different studies estimated a relative risk (RR) for neoplastic GI complications in CD     ranging from 2 to 40 and from 10 to 60 for primary gut lymphoma and adenocarcinoma,     respectively. Although uncommon, the discussed malignancies has a severe prognosis,     reflecting the need for an early diagnosis. This project aims to establish an enteroscopic     approach to improve the diagnostic timing and survival of CD patients at risk to develop SB     tumors.   "
73383|NCT02325219|"     The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to     placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A     common genetically determined, chronic, inflammatory skin disease characterized by rounded     erythematous, dry, scaling patches).   "
73384|NCT02325206|"     Dapagliflozin has been effective at lowering glucose and hemoglobin A1c (HbA1C) in subjects     with tpye 2 diabetes (T2DM), when studied as monotherapy as well as in combination with     insulin or oral anti-diabetic medications.This lead to investigations if this therapy would     also be of benefit in type 1 diabetes as intensive insulin therapy is associated with glucose     fluctuations, hypoglycemia, weight gain, and subsequent insulin resistance, all of which may     reduce efficacy.      The purpose of the pilot study is to collect clinical data on the HbA1c-dependent effect of a     single-dose of 10mg dapagliflozin on the insulin dose administered intravenously during a     glucose-infusion and an oral mixed-meal for the ensuing 24 hours with blood glucose kept     between 160 - 220 mg/dl.      The first objective is to investigate the degree of insulin dose reduction 24 hours after a     single dose of 10mg dapagliflozin in patients with type 1 diabetes Further objectives are to     investigate        -  the effect on urinary glucose excretion        -  if this effect is influenced by baseline glycemic control        -  if dapagliflozin influences postprandial insulin need        -  if dapagliflozin is associated with elevated ß-hydroxybutyrate levels        -  PK after oral administration of 10mg dapagliflozin   "
73385|NCT02325193|"     The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for     continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the     continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also     interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO, the     interruption takes place at a settled threshold level. In difference in the new system MM640G     the shutdown algorithm can already be proactive and help avoid hypoglycemia completely. The     so called PLGM algorithm (predictive low glucose management) should be tested in the user     evaluation. The main objective is to answer the question of reducing the rate of hypoglycemia     by application of the new PLGM algorithm.      Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.   "
73386|NCT02325180|"     This is a prospective, open label, randomised controlled trial to assess the safety and     efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine in children and adults     with uncomplicated Plasmodium falciparum malaria infection. Molecular markers for     antimalarial resistance will also be assessed and the presence of molecular markers in the     parasites will be associated with treatment outcomes.   "
73387|NCT02325167|"     The purpose of the study is to test the effectiveness of a short-term manualised individual     psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in     informal caregivers of palliative patients.   "
73388|NCT02325154|"     We plan to investigate the relationship between hypotensive epidural anesthesia for hip     arthroplasty and cerebral oxygen saturation.   "
73389|NCT02325141|"     Leakage is the most common complication after laparoscopic sleeve gastrectomy which may     amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A)     injection into the pyloric sphincter during the operation may decrease the risk of     postoperative gastric leakage.   "
73390|NCT02325128|"     Investigators will examine whether post-exposure naps can be used to strengthen therapeutic     extinction memories formed during exposure therapy for extreme social anxiety. Thirty-two     individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the     Liebowitz Social Anxiety Scale, by self-report during a clinical interview and by     demonstrated enhanced psychophysiological reactivity when imagining a socially stressful     scenario, will be enrolled as one of four participants in one of eight successive offerings     of a validated 5-session exposure-based group treatment for extreme social anxiety. The third     and fourth sessions conclude with each participant delivering a speech on a topic     individually chosen to elicit significant social anxiety. Following these sessions,     participants will go to the sleep laboratory where two will be given a 2-hour sleep     opportunity with polysomnographic (PSG) monitoring and two will be similarly instrumented but     undergo 2 hours of monitored quiet wakefulness. Before and after treatment, participants will     be individually assessed for social anxiety symptoms using standardized self-report     instruments and a Trier Social Stress Test (TSST) modified for continuous psychophysiological     monitoring. Ambulatory monitoring of home sleep will also be obtained using actigraphy and     sleep diaries. The investigators hypothesize that, post treatment, those individuals who     napped will show greater questionnaire-based clinical improvement as well as lesser     psychophysiological reactivity during the modified TSST compared to those who remained     quietly awake. The investigators further hypothesize that characteristics of sleep quality     and architecture during naps, specifically durations of total sleep, REM and slow-wave sleep,     as well as REM continuity, will predict greater clinical improvement and lesser     psychophysiological reactivity to the TSST in those who napped following their third and     fourth therapy sessions. Positive results will provide the first proof-of-principle for sleep     augmentation of exposure therapy for clinically significant extreme social anxiety.   "
73391|NCT02325115|"     Background: Despite current popularity, positive mental health is under researched. This is     possibly due to a lack of consensus on appropriate measuresThe Warwick-Edinburgh Mental     Well-Being Scale (WEMWBS) is a 14 positively phrased Likert-style list of items developed to     measure mental well-being. Its validation has been internationally explored. This report     presents the French validation of the WEMWBS (F-WEMWBS) in non-clinical and clinical     populations.      Methods: Two non-clinical populations comprised of 319 working adults (WORK), and 75 students     (STUD), and one clinical population of 121 patients with remitted schizophrenia (PRS) were     included in the validation study. Participants completed the F-WEMWBS as well as     complementary measures of psychological constructs potentially related to well-being.   "
73392|NCT02325102|"     Co-occurence of multiple pathogens in children is a known phenomenon, however the potential     effect on the probability to develop a disease and on its severity, as well as the     relationships between them, has not been studied adequately.      In this study, children admitted to the pediatric department with a clinical presentation of     an infectious disease were tested for the presence of multiple pathogens. Data about their     clinical status and about the accessory examinations performed during hospitalization were     collected and analyzed.   "
73393|NCT02325089|"     Sleep apnea involves significant increases in disease and death, but its consequences in     people over 65 years of age are incompletely recognized. Intraoral mandibular advancement     appliances reduce the number of apneas and hypopneas. The investigators hypothesized that     oral appliances provided to the elderly may prevent hypertension and other consequences of     sleep apnea in large populations, at a favorable cost/benefit relationship for the public     health system.   "
73394|NCT02325076|"     The airflow moving from mouth to the lungs, which can be measured by pulmonary function     tests, may be affected by the anatomic disorders of the upper airway. Difficult airway can be     considered as the anatomic disorder of the upper airway as well. Therefore, there can be a     relationship between difficult airway and pulmonary function tests. The purpose of this study     is to elucidate the association between the pulmonary function tests and difficult airway.   "
73397|NCT02325037|"     The purpose of this First-in-Human study is to evaluate the safety and tolerability after     single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also,     the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy     subjects daily for 14 days compared to placebo, will be evaluated.      Furthermore, during the course of the study after single and multiple oral dose     administrations, the amount of GLPG1837 and its metabolite present in the blood and urine     (pharmacokinetics) will be characterized.      The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be     evaluated.      The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will     be explored as well.   "
73398|NCT02325024|"     The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of     Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when     subjects have severe renal impairment or end stage renal disease (ESRD), compared with     subjects who have normal renal function.      The primary clinical hypothesis is that there will be an effect from severe renal impairment     on the PK of Sativex® when administered as a single oromucosal dose.      The study additionally aims to evaluate the safety and tolerability of the same single     oromucosal dose of Sativex® in subjects with severe renal impairment or ESRD.   "
73399|NCT02325011|"     The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a     single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and     excretes the drug) in healthy subjects with a history of cannabis use.      The primary clinical hypothesis is that no drug-drug interaction between Sativex® and     fluconazole will be detected as effects on PK parameters of Sativex®, when both are     administered to healthy human volunteers who have experience using cannabis.      The study additionally aims to evaluate the safety and tolerability of an oromucosal dose of     Sativex® in subjects when given concurrently with fluconazole.   "
73400|NCT02324998|"     Despite recent advances in the treatment of Castrate-Resistant Prostate Cancer (CRPC), there     remains an unmet medical need to identify and optimise additional treatment for those     patients with early prostate cancer who are at greatest risk of relapse following first-line     treatment with curative intent.      This is a phase I study investigating the feasibility and tolerability of a short course of     neoadjuvant treatment with olaparib, either as a monotherapy or in combination with     degarelix) given in the window-of-opportunity prior to radical prostatectomy in men with     early, localised intermediate-/high- risk prostate cancer. Our primary objective is to     determine the pharmacodynamic biomarker effects of olaparib (a PARP inhibitor) in this     patient population.      Participants will receive either single agent olaparib or olaparib in combination with     degarelix (androgen deprivation) for two weeks prior to routine radical prostatectomy. We     will use immunohistochemistry to quantify changes in the levels of biomarkers of PARP     inhibition, e.g. PAR, gamma H2AX, pH2A(s129) and Rad51 foci, using tumour samples taken at     baseline and at the time of radical prostatectomy. An intra-operative prostate biopsy will     permit us to examine biomarker variability between the samples.      The incidence and severity of Adverse Events will be documented and we will assess the number     of trial participants who undergo surgery on schedule. We will assess preliminary evidence of     tumour response, e.g. pathological changes and Prostate Specific Antigen (PSA). We also     intend to investigate changes to the ctDNA profile by comparing blood samples collected     throughout the study.   "
73401|NCT02324985|"     This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302)     applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed     onset muscle soreness.   "
73402|NCT02324972|"     The primary objective of this study is to evaluate the effect of 12 weeks of treatment with     once daily administration of AQX-1125 compared to placebo on change from baseline in Target     Lesion Symptom Score in subjects with mild to moderate atopic dermatitis   "
73403|NCT02324959|"     The purpose of this study is to determine whether acupuncture and computer-based attention     training can be combined for more effective post-stroke attentional deficits.   "
73404|NCT02324946|"     The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.      This study will compare, among patients scheduled for bariatric surgery, these two scores as     predictive scores for a difficult intubation.   "
73405|NCT02324933|"     This study will evaluate the value of dosing pain medications based upon a patient's     pre-operative tolerance to pain medications. Study participants will be assigned to one of     two groups, a treatment group and a control group. The treatment group will be given pain     medications after surgery based upon their measured response to pain medications prior to     surgery. The control group will be given pain medications based upon the normal dosing     routine as is currently practiced. Both groups will be closely monitored for side effects and     have their pain scores recorded for the first 48 hours following surgery.   "
73406|NCT02324920|"     The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition     to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that     DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or     partially by transforming syncope in pre-syncope.   "
73407|NCT02324907|"     The purpose of this study is to determine the clinical efficacy of a novel dynamic     compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.   "
73408|NCT02324894|"     Mammography remains an imperfect screening test especially in women with extremely dense     breast tissue, missing biologically aggressive cancers especially in younger population and     picking up indolent cancers that do not need treatment.      The most sensitive test for breast cancer detection at our disposal is magnetic resonance     imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST     Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and     specificity values.      Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer     screening: it is safe, does not induce cancers, and can find more cancers than mammography.      However this study was performed in women with low to moderately increased risk.The value of     FAST Breast Magnetic Resonance in normal screening population has to be assessed before a     modification of current strategy of breast cancer screening with mammography.   "
79019|NCT02251548|"     This research study is evaluating a new drug called ibrutinib in combination with the     standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment for     Chronic Lymphocytic Leukemia (CLL).   "
73409|NCT02324881|"     This pilot clinical trial studies a pain management smartphone application for monitoring     pain in patients with locally advanced head and neck cancer who are undergoing radiation     therapy. The study is also open to patients with esophageal or lung cancer. A smartphone     application may allow patients to assess their symptoms in a manner that is closer to     real-time than having to recall pain episodes during once weekly on-treatment visits with a     health care provider. This real-time monitoring may improve the timing and efficacy of     interventions leading to better pain-control and quality of life.   "
73410|NCT02324868|"     Venous catheters are necessary for the treatment of many patients. Showering with a venous     catheter is often prohibited due to the infection risk when the insertion site becomes wet.     Therefore these patients are challenged to keep the catheter insertion site dry and always     covered with a dressing. Washing themselves is often impossible without assistance of a nurse     or significant other. For patients with a catheter connected to an infusion line, it is even     more difficult. Showerpatch is a newly developed dressing that safeguards the insertion site     of an IV catheter from water during bathing activities. The purpose of this trial is to     evaluate the impact of the availability of Showerpatch by comparing the outcomes in patients     regarding the patient's autonomy in bathing activities, the material use and the time needed     from caregivers in home care. Additionally qualitative data on patient's bathing activities     and the use of Showerpatch will be collected.   "
73411|NCT02324855|"     The main aim is to analyze whether the routine use of chest physiotherapy in non cystic     fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this     population. In addition, the secondary end-points include incidences of exacerbations,     changes in lung function, exercise capacity, airways inflammation, sputum analysis and     eventual adverse events.   "
73412|NCT02324842|"     Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can     prevent the increase in HGP following institution of canagliflozin therapy and produce an     additive or even synergistic effect to lower the plasma glucose concentration and A1c.      Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin     can produce an additive, or even synergistic, effect to promote weight loss and reduction in     hepatic and visceral fat content.      Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin     can produce an additive or even synergistic effect to reduce systolic/diastolic blood     pressure and 24-hour integrated blood pressure.   "
73413|NCT02324829|"     Physiotherapists spend a large amount of their time with patients observing their     rehabilitation techniques. A patient going through rehabilitation exercises are routine and     does not necessarily require the attention of the physiotherapist. This research will develop     a sensor system that will be strapped onto the patients and will provide feedback on how     accurately the exercise is being executed. This will free up the physiotherapist to focus on     diagnosis and other tasks that will better utilize the physiotherapist's training. A previous     study has shown that this system is feasible for healthy subjects. This study would test to     see if this system is extendable to rehabilitation subjects.   "
73414|NCT02324816|"     Evaluate the performance of a cryolipolysis system using a colder treatment parameter for     non-invasive reduction of subcutaneous fat in the lateral thighs.   "
73415|NCT02324803|"     assess the activity and toxicity of second-line treatment with pazopanib after failure of     first-line sunitinib treatment in patients with clear cell mRCC; to investigate the potential     association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical response to     pazopanib in mRCC patients.   "
73416|NCT02324790|"     This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep     Therapy System for the treatment of obstructive sleep apnea.   "
73417|NCT02324777|"     Primary Objective:      - To determine the analgesic dose-response characteristics of vapourized cannabinoids with     varying degrees of delta-9-tetrahydrocannabiol (THC)/ Cannabidiol (CBD) ratios.      Secondary Objectives:        -  To compare functional changes and patient preferences of different cannabinoid (THC,          CBD) profiles in patients with OA (Osteoarthritis);        -  To describe the Pharmacokinetics (PK) of vapourized cannabis of differing cannabinoid          profiles in patients with OA;        -  To explore the short term safety of vapourized cannabis with different cannabinoid          profiles.        -  To describe the incidence and severity of psychoactive events.   "
73418|NCT02324764|"     The objective of this study is to determine the rate of radial artery occlusion and vascular     access site complications following transradial angiogram using a new Terumo (Tokyo, Japan)     Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.   "
73419|NCT02324751|"     Using an established model of human typhoid infection, whereby healthy adults are     deliberately exposed to typhoid-causing bacteria, the investigators will determine how     effective a new typhoid conjugate vaccine (Vi-TCV) is in preventing infection. The new     typhoid vaccine will be compared with a control vaccine (meningococcal ACWY). The protective     effect of a currently used typhoid polysaccharide vaccine (Vi-PS) will also be studied and     compared with the control vaccine using this model of typhoid infection.      A second component of this study will involve vaccinating 15-20 participants with Vi-PS.     Serum will be obtained prior to vaccination and 4-6 weeks after vaccination. The     post-vaccination serum will be pooled and used to create an anti-Vi IgG serum standard.   "
73420|NCT02324738|"     This is an open-label sequential pharmacokinetic study in 16 healthy glucose-6-phosphate     dehydrogenase (G6PD) normal Thai subjects at Faculty of Tropical medicine, Mahidol     university.      The 16 subjects have already participated in a healthy volunteer studies in the past either     i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered     primaquine and dihydroartemisinin-piperaquine (DHA-PQP) in Healthy Adult Subjects or ii)     Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of     chloroquine and piperaquine in healthy Thai subjects      Every subject was administered a single dose of three tablets of DHA-PQP from previous     studies. To avoid unnecessary exposure of DHA-PQP again, we propose to include the results of     DHA-PQP arm from these previous studies and ask the healthy subjects to participate this     study for receiving only single dose of three tablet of DHA-PQP (40mg/320mg) and two tablet     of Mefloquine (250mg) on first admission and single dose of two tablet of Mefloquine on     second admission.   "
73421|NCT02324725|"     This study evaluates the biological markers of treatment of opioid dependent individuals with     an extended release formulation of the opioid antagonist naltrexone. The biological measures     include functional MRI, blood levels of naltrexone and its metabolites, urine toxicology and     behavioral tests probing various aspects of personality, memory, reward processing and     attention.   "
73422|NCT02324712|"     Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines     and growth factors in the circulating blood (and cytokine levels only in saliva) of patients     with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine     differences in cytokine profiles between real and sham acupuncture in circulating blood of     patients with chronic TMD; and 3) To explore correlations between these changes and clinical     outcomes.      Participants: Patients with chronic TMD pain recruited through the University of North     Carolina-Chapel Hill (UNC-CH) Orofacial Pain Clinic.      Procedures (methods): Participants will complete a self-administered questionnaire assessing     TMD-related comorbidity. During the initial visit, study examiners will record clinical     characteristics of muscles and joints of the head, neck and body according to newly     recommended diagnostic criteria (DC) for TMD. Clinical outcomes include a pain index     (computed from numeric rating scales) of masseter, temporalis and the supplemental painful     muscles, and patient-reported symptoms (using the Measure Yourself Medical Outcome Profile;     MYMOP) and pain intensity (using the Pain Scale). Blood (5 cc) will be taken before and after     acupuncture treatments. Participants will self-collect pre-treatment and post-treatment     saliva samples. Patients will receive 4 acupuncture treatments, once per week for 4 weeks.     The primary outcome measure is change in IL-8 levels in circulating blood and saliva after 4     weeks of real acupuncture compared with sham acupuncture. Secondary outcome measures include     comparing changes in levels of nerve growth factor (NGF), tumor necrosis factor-alpha     (TNFα),vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF),     basic fibroblast growth factor (bFGF), and IL-1α, IL-2, IL-4, IL-6 and IL-10, before and     after real acupuncture at Week 1 compared with sham acupuncture and before and after real     acupuncture at Week 4 compared with sham acupuncture. The exploratory outcome measure is     correlation between changes in cytokine levels and clinical variables after 4 weeks of real     acupuncture compared with 4 weeks of sham acupuncture.   "
73423|NCT02324699|"     Use of co-induction with corticosteroid therapies may accelerate the remission rate when used     with vedolizumab. Further, this may lead to higher rates of response and remission at week 10     than would be seen with vedolizumab monotherapy.   "
73424|NCT02324686|"     The purpose of this study is to determine whether vitamin K supplementation will improve     anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation.     Patients who participate will receive vitamin K1 three times a week on dialysis days for a     period of four months. INR levels collected during this period will be compared to the four     month period prior to receiving the vitamin K1 to determine if vitamin K improves the     standard deviation of INRs and time in therapeutic range.   "
73425|NCT02324673|"     This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety,     tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral     Solution in a sequential fashion.      Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant     seizures, and satisfy all inclusion/exclusion criteria.   "
73426|NCT02324660|"     Several studies and registries suggested that the concomitant presence of acute coronary     syndromes (ACS) and chronic obstructive pulmonary disease (COPD) is significantly associated     with poor prognosis. It has been suggested that diagnosis of COPD is frequently missing.     Thus, it is plausible that a significant percentage of patients with ACS may have     unrecognized COPD. This missing diagnosis may contribute significantly to poor prognosis. The     investigators suppose that the concomitant use of peak expiratory flow (PEF) measurement and     of Respiratory Health Screening Questionnaire (RHSQ, adapted version) could be useful as     screening test for COPD in patient smokers or former smokers admitted to hospital with a     diagnosis of ACS. In all screened patients COPD diagnosis will be confirmed (or not) two     months after hospital discharge with spirometry. In the same setting of patients, the     investigators will characterize the underlying pathological mechanisms, evaluating several     inflammation, platelet and endothelial markers.   "
73427|NCT02324647|"     Standard diagnostic work-up for adrenal incidentalomas (AI) consists of periodical     biochemical analysis and CT-scanning in case the initial work-up does not demonstrate the     presence of hormonal hypersecretion or adrenocortical carcinoma (ACC), respectively. The     overall aim of this study is to improve the cost-effectiveness of the diagnostic strategy for     AI. Cost-effectiveness of urine steroid profiling (USP) will be compared to the standard     diagnostic strategy of repeated CT-imaging.   "
73428|NCT02324634|"     Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand function,     muscle weakness, pain, and joint deformities are persistent and disabling problems for nearly     half of all stroke survivors. This can, in part, result from patients not getting adequate     therapy targeting the hand and arm in the very early stages of rehabilitation. Previous     research has highlighted the importance of early rehabilitation interventions after stroke.     Although in stroke patients the damage is to the brain rather than the limbs, muscle wastage     (atrophy) can occur soon after stroke through non-use. Muscle atrophy can even occur in those     who have retained some degree of active arm movement. Electrical stimulation (ES) is a     painless treatment in which small pulses of electrical current from a battery operated     portable device are used to activate a paralysed muscle and produce a strong muscle     contraction. ES has been shown to increase brain activity and can hence influence the     formation of new nerve pathways (known as neuroplasticity) to replace those damaged by     stroke. Previous studies have concluded that six weeks of ES to the muscle on the back of the     forearm improved the chance of a person recovering arm function. However, as the intensity of     treatment was not sufficient to prevent the complications identified in this proposal, the     impact of any functional benefit was significantly limited. We plan to build on previous     research by training clinical therapists to operate ES devices; starting ES much earlier     after stroke; applying a higher intensity treatment to more of the forearm muscles (i.e. both     the front and back of the forearm) and providing treatment for a longer period of time than     previously carried out. We will evaluate the feasibility of incorporating ES into a patient     self-management programme to enable independent use outside of routine therapist led     rehabilitation sessions.   "
73429|NCT02324621|"     This phase I trial studies the long-term side effects of the continuation of oral ONC201 in     treating patients with solid tumors that have spread to other places in the body who have     previously benefited from receiving this drug. Oral ONC201 may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
73430|NCT02324608|"     This pilot clinical trial studies the side effects and how well cetuximab before surgery     works in treating patients with skin cancer that forms, grows, and spreads quickly and has     spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as     cetuximab, may block tumor growth in different ways be targeting certain cells. Giving     cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue     that needs to be removed.   "
73431|NCT02324595|"     Phase II multicentric study   "
73432|NCT02324582|"     This is a single center Phase I safety and efficacy study of MK-3475 therapy used in     combination with bladder infused BCG treatment for patients, 18 years or older, with high     risk superficial bladder cancer (cancer not yet involving the muscle of the bladder wall) who     have had removal of their bladder tumor. Patients will be enrolled to a single treatment     group of a fixed dose of MK 3475 and BCG.   "
73433|NCT02324569|"     The purpose of this study is to evaluate the efficacy and safety of SYR-472 when administered     at a dose of 100 mg once weekly as an add-on to insulin therapy (SYR-472 100 mg     combination/SYR-472 100 mg combination group) using insulin preparation alone/ SYR-472 100 mg     combination group as a control in patients with type 2 diabetes mellitus and inadequate     glycemic control despite treatment with insulin preparations in addition to diet and/or     exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when     administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with     type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin     preparations in addition to diet and/or exercise therapy.   "
73434|NCT02324556|"     All patients planned for an anterior resection due to rectal cancer with a total mesorectal     excision are included. This is a feasibility study, thus no randomization will be performed.      Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points     include clinical variables such as conversion rate, re-admission and/or re-operation due to     any complication and health economy analyses.   "
73435|NCT02324543|"     This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination     with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with     metastatic pancreatic cancer.   "
73436|NCT02324530|"     This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm     motion, heart position and tumor motion compared to free breathing. Only patients with     significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry     (heart close to chest wall) identified on standard imaging and simulation will be candidates     for the study. Patients will be re- simulated and planned for radiation treatments with CPAP.     The radiation plans generated with and without CPAP will be compared to evaluate the impact     of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart     and lung.   "
73437|NCT02324517|"     Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other     severe bleeding disorders could be monitored and guided based upon special clotting assays ,     eg thrombin generation and thromboelastography. In this study blood sampled from patients     with bleeding disorders will be evaluated applying ex- vivo spiking assays with various     coagulation concentrates to potentially address the feasibility of replacement /bypass     agents/ combined therapy for future bleeding episodes. Patients that will be further treated     by any regimen potentially suggested (as standard care- not within trial) will be thereafter     followed , including repeated lab studies to assess the impact of therapy upon hemostasis.   "
73438|NCT02324504|"     This study will enroll up to 192 children less than 18 years of age, who will receive     electrocardiographic guidance for placement of a PICC in addition to radiography done as     standard care. The investigators will determine the location of the PICC tip from both ECG     and radiograph, and then measure the degree of correlation between the two methods.   "
73439|NCT02324491|"     The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese     adult subjects with type 2 diabetes mellitus.   "
73440|NCT02324478|"     The autonomic nervous system state (ANSS) and the autonomic nervous system state index     (ANSSi) - two indices derived from the pulse photo-plethysmography analysis - have been     recently advocated as a measure of sympathetic activity in the anesthetized patients, but     their validity has not been yet demonstrated. We will conduct a study aiming to assess if     ANSS and ANSSi reflect autonomic nervous system modulation on cardiovascular system in     healthy humans under general anaesthesia.   "
73441|NCT02324465|"     The investigators plan to conduct a randomized trial comparing the intubation success rate     and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order     to demonstrate the comparability of the devices.   "
73442|NCT02324452|"     In this study it will be determined whether the rate of severe toxicity associated with     fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished     by individualized dosing of fluoropyrimidines based on upfront genotypic assessment of     dihydropyrimidine dehydrogenase (DPD) deficiency.      In addition to the genotyping, the DPD phenotype of all patients will be determined by     measuring the baseline dihydrouracil/uracil (DHU/U) ratio, in order to investigate whether     phenotype-guided treatment can further improve patient safety. In a subgroup of patients,     other phenotyping methods will be tested: measuring the plasma levels of uracil after a     uracil test dose and a uracil breath test after a dose of [2-13C] -labeled uracil. To     validate these tests, these phenotyping results will be compared with the results of a DPD     activity assay (which measures DPD enzyme activity in peripheral blood mononuclear cells),     which is considered the gold standard in measuring DPD phenotype.   "
73444|NCT02324426|"     Excessive free radical formation and depletion of the brain's primary antioxidant,     glutathione, are established components of Parkinson's disease (PD) pathophysiology. While     there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some     preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles     surrounding currently employed delivery methods have hindered the clinical utility of this     therapy. Intranasal GSH, (in)GSH, is a novel method of glutathione augmentation. The aim of     this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in brain     glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15     individuals with PD.   "
73445|NCT02324413|"     Children who are upset during induction of general anaesthesia are frequently distressed     postoperatively and are more likely to demonstrate negative behaviour changes.      This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia     to identify whether postoperative behavioural disturbance may be minimised.   "
73446|NCT02324400|"     The study is intended to verify the safety and assess the performance of up to 3-days     treatment protocol with the RenaSense System in ADHF patients.   "
73448|NCT02324374|"     This will be a pilot study to evaluate the role of endocytoscopy in classifying colorectal     polyps in vivo. The primary outcomes will be to determine the key endocytoscopy image     features of neoplastic and non-neoplastic colorectal polyps. The target population will     include adult subjects undergoing screening and surveillance colonoscopies.   "
75230|NCT02301091|"     The purpose of this study is to determine whether combined radiofrequency ablation and     transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in     patients with HCC and portal vein tumor thrombus.   "
73449|NCT02324361|"     To date, approaches that show the most promise for preventing and/or reversing the course of     childhood obesity involve the delivery of intensive lifestyle interventions within a     family-based context, emphasizing the necessity of parental involvement and making changes in     family routines and the home environment. Considering that the current demand for pediatric     weight management programs far exceed availability, as well as the high attrition rates     observed in such programs, there is a great need for more accessible and efficient means of     delivering these interventions to reduce the burden of childhood obesity.      The goal of this study is to understand whether text messaging and social media platforms can     be leveraged to address the important issue of childhood obesity by engaging parent/guardians     in one of these strategies, and whether these strategies produce similar outcomes. No     existing study has compared these strategies head-to-head, and the investigators believe that     this project will be instrumental in understanding the determinants of success in these     strategies and allow us to collect sufficient intelligence to be able to deploy these     meaningfully to patients as part of usual care.   "
73450|NCT02324348|"     It is known that no reflow phenomenon by microvascular obstruction after revascularization in     STEMI increase infarct size, cardiac remodeling, and a risk of late mortality. Major     mechanism of microvascular obstruction is distal embolization during procedure. Some     investigators showed deferred stenting decreased the degree of microvascular obstruction     compared with immediate stenting in STEMI. The aim of current study is to compare impact of     immediate stent implantation versus deferred stent implantation on infarct size and     microvascular perfusion in patients with ST-segment elevation myocardial infarction (STEMI).   "
73451|NCT02324335|"     Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation     regimens used to treat cancer. This study examines the investigational drug brilacidin and     its possible application in prevention of oral mucositis in patients undergoing     chemoradiation for treatment of head and neck cancer.   "
73452|NCT02324322|"     The purpose of this research study is to evaluate an exoskeleton device and mobility skills     in the device.   "
73453|NCT02324309|"     The study is designed to compare meal time glucose control associated with BIOD-531, a     rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R     U-500 in patients with diabetes and severe insulin resistance.   "
73454|NCT02324296|"     ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC),     although no improvement in overall survival (OS) has been done in the last 25 years , with     Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median     survival of about 7-8 months in patients with extended disease (ED).      In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant     advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and     Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen     in SCLC.      Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16     females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2,     Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.      Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per     patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%),     1 in 13 patients (28%) and 2 in 4 patients (9%).   "
73455|NCT02324283|"     Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and     recovery time, and perioperative oxygenation in lung resection surgery?   "
73456|NCT02324270|"     To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against     Flector patch in the treatment of pain in subjects with minor ankle sprain   "
73457|NCT02324257|"     Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical     study of single-agent RO6958688 in participants with locally advanced and/or metastatic     carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard     treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The     study will be conducted in two parts. Part I of the study will investigate the safety and     pharmacokinetics of a single dose of RO6958688 in single participant cohorts with dosing     starting from a minimal anticipated biological effect level dose of 0.05 milligrams (mg) and     up to a maximum dose of 2.5 mg. Part II will establish the appropriate therapeutic dose based     on safety, pharmacokinetics, and the maximum tolerated dose (MTD) of RO6958688 for the once     per week (QW) regimen, every three weeks (Q3W) regimen, and for the step up dosing regimen.     The overall target sample size is approximately 185 evaluable participants.   "
73458|NCT02324244|"     Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a     broad cohort of consecutive immunocompetent adults admitted to a major heart surgery     intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors,     and clinical significance of CMV infection.   "
73459|NCT02324231|"     In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover     non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer     requiring chemotherapy, primarily the safety, and secondarily the efficacy and other     endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for     the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is     assessed by the rate of safety relevant events per chemotherapy exposure time, a composite     endpoint including serious medical complications and bacteremia during FN. Patients are     repeatedly randomized (cluster: study site) to the high or the low TLDF every month,     resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be     inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of     safety relevant events is proven, with a single-sided non-inferiority margin of 1.33,     applying mixed Poisson regression.   "
73460|NCT02324218|"     This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among     diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large     population-based cohort in United Kingdom (UK) using data from the CPRD database.   "
73906|NCT02318381|"     Aim of this prospective double blind randomized clinical trial is to understand the     correlation of suprascapular neuropathy in the setting of large and massive tears of the     shoulder rotator cuff and to investigate whether arthroscopic dissection of the superior     transverse scapular ligament is positively related to the improvement of this neuropathy.   "
73461|NCT02324205|"     The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both     digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with     other subject data including histology results from biopsy specimen examination and cancer     classification data from initially asymptomatic women referred for biopsy after recall from     screening and diagnostic work-up. These data will be included in a subsequent and     prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining     superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance     measures.   "
73462|NCT02324192|"     Objective: To evaluate the correlation / association between inflammatory ultrasonography     findings and clinical /functional assessment in symptomatic hand OA interphalangeal joints     (IP). To evaluate the intra and interobserver reproducibility of ultrasound findings.      Methods: It was conducted a prospective study in 60 symptomatic hand OA patients. They were     assessed in six times (T0, T1, T4, T8, T12 and T48 weeks) by blind observers (clinical and     ultrasonography). The intra and interobserver reproducibility analysis was performed in 25%     of the sample. Differences were considered as statistically significant when p< 0.05.   "
73463|NCT02324179|"     Our objective is to determine whether HIV infected youth have higher level of endothelial     dysfunction, as measured by Peripheral Arterial Tonometry, when compared to age matched     healthy controls. The investigators also aim to gather preliminary data on whether     endothelial Peripheral Arterial Tonometry (endoPAT) measurements of endothelial dysfunction     are independently associated with HIV and antiretroviral factors, and with markers of     inflammation and traditional cardiovascular disease risk.   "
73464|NCT02324166|"     In retinal surgery, endophthalmitis is a sight-threatening eye infection that could     complicate patient vision after the operation. At Toronto Western Hospital, for retinal     surgery (operating at the back of the eye) it is common practice to administer an antibiotic     (cefazolin) at the end of surgery, to reduce the risk of post-operative endophthalmitis. The     antibiotic is administered by injection underneath the part of the eye called the     conjunctiva. However, this antibiotic injection is often associated with high levels of     post-operative pain. Previous studies have observed a reduction of this pain by injecting an     anesthetic (lidocaine) in the subconjunctival space before the antibiotic. This study will     seek to examine whether mixing 2% lidocaine with cefazolin before its injection will reduce     post-operative pain in the retinal surgery setting.   "
73465|NCT02324153|"     This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness     and safety of peri-operative administration of ramelteon, a melatonin agonist in the     prevention of postoperative delirium.   "
73466|NCT02324140|"     The study investigates inflammatory and antiinflammatory response in patients with severe     aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement)     or interventional cardiology treatment (transcatheter aortic valve implantation using the     transfemoral access route or the transapical access route).   "
73467|NCT02324127|"     Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver     diseases.   "
73468|NCT02324114|"     Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign     colorectal diseases patients.   "
73469|NCT02324101|"     Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign     breast diseases patients   "
73470|NCT02324088|"     To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after     pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory     breast cancer (IBC).   "
73471|NCT02324075|"     Background (brief):        1. Burden: In low income neighborhoods in Dhaka many households share toilets which are          often unsanitary and their discharge contaminates the community.        2. Knowledge gap: Behavior change messages have the potential to make people concerned          about maintaining shared toilets quality, cleanliness and safety of the facility. There          are many contributors to poor sanitation in low income neighborhoods in Dhaka but it's          not clear that the situation can be improved with behavior change or even which specific          messages to target.        3. Relevance: Water Sanitation for the Urban Poor (WSUP) is a nongovernmental organization          working to improve shared sanitation facilities in Dhaka. They are interested in          developing and evaluating a behavior change program to improve shared sanitation in          Dhaka and to generate lessons that would be relevant for other low income urban settings          globally.      Hypothesis: A behavior change communication intervention can improve the quality and     cleanliness of sanitation services available to low-income residents of Dhaka.      Objectives:        1. To deliver behavior change messages (which target key behaviors influencing the quality          and cleanliness of shared sanitation facilities) to randomly selected low-income          communities in Dhaka.        2. To evaluate the effectiveness of a behavior change communication intervention designed          to change targeted behaviors related to the quality and cleanliness of shared sanitation          facilities.      Methods:      Local non-governmental organizations will deliver the intervention (behavior change     communication package) in randomly selected communities. For this study the investigators     will assess the impact of this intervention on the targeted behaviors using follow-up surveys     and spot checks.   "
73472|NCT02324062|"     This study is about understanding the use of a genetic test (Myriad Genetics myRisk panel)     that analyzes 25 genes related to different hereditary cancer conditions. The investigators     hope to learn more about how this type of genetic test is used clinically. The investigators     also hope to understand more about the experience of individuals and families who undergoing     this test of genetic testing.   "
73473|NCT02324049|"     To evaluate the safety and tolerability of intravenous (IV) administration of SBC 103 in     subjects with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) with evaluable signs     or symptoms of developmental delay.   "
73474|NCT02324036|"     The proposed study is a pilot study to gather data on the effectiveness and feasibility of a     software tool (EMPATHy) to help patients communicate effectively with doctors about problems     they face with their medication regimens. EMPATHy will be incorporated into an existing     clinic-based intervention called Coached Care, in which community health workers (CHWs,     non-professional community members) work as a Coach to patients to help them improve     engagement and communication during the medical visit.   "
73500|NCT02323698|"     Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods     (termed intermittent hypoxia) is a safe and effective treatment strategy to promote     meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of     the study is to understand how caffeine may augment the effects of intermittent hypoxia on     motor function and spinal plasticity (ability of the nervous system to strengthen neural     pathways based on new experiences) following SCI.   "
73501|NCT02323685|"     Safety and effect of SANGUINATE on patients DCI following SAH.   "
74870|NCT02305771|"     The aim of the study is to demonstrate that our semantic knowledge (elements of our long-term     memory and the process we use them) respond to a graphic organisation and gather together     following accurate patterns called cliques (neural networks).   "
73475|NCT02324023|"     Cancer in the colon and rectum represents a global health burden being the most common cancer     of the digestive tract. It is the second most common cancer in Denmark and only about half of     the patients survive this diagnosis. Thorough characterization of the tumour preoperatively     is very important, since it determines if the patient should be treated with chemotherapy     before operation and, in the future, which operation would be most suitable for the patient.      Research has shown that endoscopic ultrasound (EUS) is superior to a CT-scan, in determining     the local growth of the tumour in rectal cancer. Today, a CT-scan is the image modality of     choice, and is used in all Danish hospitals when it comes to colon cancer. Hopefully, the     investigators can apply EUS in colon cancer patients and thereby alter our diagnostic     approach, towards a quicker and safer way to determine which treatment the investigators     should offer the patient.      With the screening programme for colorectal cancer in Denmark the investigators will find     more and more cases of colorectal cancers, especially in the early stages, before symptoms     begin. These small tumours put doctors in several dilemmas concerning the strategy of     treatment. Even today, the investigators are very reluctant in offering large-scale     operations to elderly and fragile patients who have been diagnosed with cancer in the rectum.     Instead, local endoscopic operations are performed in selected patients. This approach has     not yet been tried in early colonic cancers. However, it might turn out that local,     endoscopic surgery will show to be beneficial for patients with colon cancers and maybe even     decrease morbidity, mortality and the regenerative period after surgery.      The aim of this PhD-project is to investigate the utility of the EUS-method in characterizing     tumours in the colon and in investigating the blood flow in the tumour.   "
73476|NCT02324010|"     The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial     glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying,     after a mashed potato meal in patients with type 2 diabetes.   "
73477|NCT02323997|"     This study will investigate the types of HPV in samples from women with cervical pre-cancer     and cancer and gather information to help investigate the impact of HPV vaccination in     Switzerland.   "
73478|NCT02323984|"     Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC     Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium     assessment through standardized questionnaires will be done at baseline (day of the surgery -     pre operatory), immediately after surgery (in post anesthesia care unit) and then every 12     hours in Day 1 and Day2 after surgery. The investigators will use linear mixed models to     describe the change patterns overtime, and compare differences at each time point.     Inflammatory biomarkers will be explored overtime as well. The investigators will also     explore age effect on cognitive function - cognitive reserve - based on the score of the     cognitive test administered at baseline.   "
73479|NCT02323971|"     Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the     treatment of the prevention of the thrombotic events in patients with coronary artery disease     (CAD), showing a reduction in adverse events.   "
73480|NCT02323958|"     This study is to observe whether transcutaneous electrical stimulation at specific acupoints     could improve the quality of emergence in patients undergoing robotic laparoscopic     gynecologic surgery.   "
73481|NCT02323945|"     Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods     (termed intermittent hypoxia) is a safe and effective treatment strategy to promote     meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of     the study is to understand the mechanisms by which intermittent hypoxia enhances motor     function and spinal plasticity (ability of the nervous system to strengthen neural pathways     based on new experiences) following SCI.   "
73482|NCT02323932|"     The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral     cochlear implant hearing in comparison to unilateral cochlear implant hearing in the     perception of speech intonation.   "
73483|NCT02323919|"     Using a randomized clinical trial with 3 groups, the investigators will conduct a     head-to-head evaluation of two different theoretically-based interventions, SystemCHANGE and     CHANGE+, as compared to Usual Care to improve the adoption and maintenance of exercise in     older cardiac patients. SystemCHANGE, a novel intervention that focuses on environmental     change uses System Improvement strategies to increase exercise, will be compared to CHANGE+     (an intervention based contemporary cognitive behavioral strategies). Study questions are:     (1) Is there a difference between SystemCHANGE, CHANGE+ and Usual Care in exercise adoption     when controlling for covariates (age, race, functional capacity, body fat, co-morbidity,     muscle or joint pain, exercise experience, home and neighborhood environment, and     depression), for individuals following a cardiac rehabilitation program (CRP)? (2) Is there a     difference between SystemCHANGE, CHANGE+, and Usual Care in exercise maintenance when     controlling for covariates? (3) Do system changes, social support for exercise,     problem-solving skills, motivation, health beliefs, and exercise self-efficacy mediate the     effects of SystemCHANGE, CHANGE+, or Usual Care on exercise adoption? (4) Do system changes,     social support for exercise, problem-solving skills, motivation, health beliefs, and exercise     self-efficacy mediate the effects of SystemCHANGE, CHANGE+ and CHANGE+ interventions in terms     of health care spending, labor force participation and earnings, and household productivity?      Older persons (N=420) recovering from cardiac events will be randomly assigned to the three     groups. Measures of exercise adoption and maintenance (# of metabolic equivalents {METS}     expended, and whether or not a subject remains exercising) will be taken for 1 year after     completion of a CRP using heart rate wristwatch monitors, exercise diaries, and 7-Day Recall     Survey. The effect of covariates also will be assessed. Mechanisms by which the interventions     achieve their effects will be determined. Multivariate analyses will examine and compare the     effects of the interventions over time. A cost-effectiveness analysis also will be conducted.   "
73484|NCT02323906|"     CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in     combination with sorafenib for subjects with unresectable HCC who have received no prior     systemic therapy for HCC. The dose escalation phase of the study will explore several dose     levels of CC-122 in combination with sorafenib, followed by an expansion part of the study     using the optimal combination dose regimen.   "
73485|NCT02323893|"     The goal of this study is to visualize biodistribution of a PET tracer called [18F]F-AraG     through time in healthy human volunteers.   "
73486|NCT02323880|"     This phase I trial studies the side effects and best dose of selinexor in treating younger     patients with solid tumors or high-grade gliomas that have come back (recurred) or do not     respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading.   "
73487|NCT02323867|"     This is a single arm pilot study for patients using α/β T cell-depleted PSCT in with     alternative donor sources with hematologic malignancies receiving alternative donor     (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the     CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as     determined by engraftment and GVHD, and one year leukemia free survival.   "
73488|NCT02323854|"     Post market prospective, non-randomized, single-arm, multicenter study, designed to     demonstrate dose response of an ablation system using a percutaneous approach in patients     with primary, metastatic, or recurrent primary lung tumors.   "
73502|NCT02323672|"     45 individuals were subdivided into 3 groups, 15 patients with oral premalignant lesions, 15     patients with oral malignant lesions and 15 control individuals. Levels of chemerin and MMP-9     were evaluated in serum and saliva of these subjects utilizing the ELISA technique.   "
73489|NCT02323841|"     Currently conservative treatment for patients of childbearing affected by cervical cancer is     reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The     trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these     patients wishing to preserve their reproductive function.      In this context , recently literature show the results about the use of neo-adjuvant     chemotherapy about the reduction of tumor volume and therefore the magnitude of the     subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it     becomes crucial a prospective analysis on the possibility to include in this type of     treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) .      The current study , in fact , would like to do a prospective evaluation on the advantages of     neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to     conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with     tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.   "
73490|NCT02323828|"     Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn     starch on food intake and appetite control of a cohort of healthy students. Cookies were     prepared with increasing RS content and were fed to 18 healthy students in a blind trial     versus a placebo.      Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet     diaries, respectively).   "
73491|NCT02323815|"     Globally, child undernutrition is the underlying cause for 3.1 million deaths of children     younger than 5 years. 18.7 million children under five years of age suffer from severe acute     malnutrition (SAM) and an additional 33 million children suffer from moderate acute     malnutrition, and are at risk of developing SAM      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute     malnutrition and programs that focus on the prevention of acute and chronic undernutrition -     resulting in many missed opportunities for using prevention platforms to screen and refer SAM     children, or for using screening and referral platforms to provide prevention services.      This project will address two critical gaps related to the integration of preventive and     treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically     integrated into routine health-center visits or mainstreamed into community outreach     programs; and 2) screening programs do not offer any preventive services for those children     found not to be suffering from MAM/SAM at the time of screening; mothers of children     identified as non-MAM/SAM case are usually sent home without receiving any health or     nutrition inputs and as a result, may fail to come back for screening because they do not see     any tangible benefit associated with their participation in the screening. This project will     specifically address these gaps by assessing the effect of an integrated approach consisting     of higher screening coverage and preventive Behavior Change Communication (BCC) +     Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment     of child undernutrition.   "
73492|NCT02323802|"     Results after interventions on lifestyle in the secondary prevention of ischemic heart     disease are not always consistent, and the Guidelines multidisciplinary measures aren't     easily achievable.      Therefore, the purpose of this research project is the identification of an interventional     approach to effective secondary prevention and realistic feasibility, in a field of     multifactorial risk. The study is open to patients who totaled a double chronic disease,     obesity/overweight and coronary heart disease, and who experienced a first event of ischemic     cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational     intervention in a sample of overweight and obese patients (BMI > 24.9) incurred in a first     episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic     approach of prescriptive diet therapy.   "
73493|NCT02323789|"     To assess whether intravenously administered third-party bone marrow-derived mesenchymal     stromal cells (MSCs) are safe and have an impact on disease severity in RDEB   "
73494|NCT02323776|"     The purpose of this study is to identify features of the cumulative dose-volume histogram     (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate these     with postoperative complications.   "
73495|NCT02323763|"     The investigators propose to explore the link between bipolar disorder, anxiety, and suicide     by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and     II disorder who have various levels of anxiety. The investigators will determine the effect     of anxiety on their intertemporal discounting (small rewards now compared to larger rewards     later) in a decision-making paradigm and investigate the associated functional neuroanatomy     using functional magnetic resonance imaging (fMRI).   "
73496|NCT02323750|"     TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular     dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify     parameters/ biomarkers promoting and predicting the individual risk of transition. Results     from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The     implementation of common patient data sets and biobanking standards will enable data and     biomaterial sharing with other DZHK study groups. This study will set the standard for a     unique DZHK heart failure database and Biobank for innovative preclinical and clinical     trials.   "
73497|NCT02323737|"     Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned     to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of     efficacy and toxicity of IP regimen was analyzed.   "
73498|NCT02323724|"     To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E     BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V     of Bethesda System)   "
73499|NCT02323711|"     This study is investigating the relative risks and benefits of using two common materials for     coverage of the skin incision at cesarean delivery. We will perform the first prospective and     the first randomized controlled trial examining the use of a standard postoperative dressing     versus skin glue for coverage of the closed skin incision after cesarean delivery. The     hypothesis is that using skin glue for coverage of the incision will be associated with     decreased wound complications and increased patient satisfaction.   "
73503|NCT02323659|"     Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life     in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy     treatment.   "
73505|NCT02323633|"     Children with ADHD display a certain brainwave profile which might be different to that of a     child who does not have ADHD. Treatment with tPCS (transcranial pulsed current stimulation)     has shown that this brainwave profile could possibly be altered to more closely resemble a     brainwave profile of a child who does not have ADHD. Researchers believe that by changing     this brainwave profile it might lessen symptoms of ADHD.      tPCS is a name used to describe the type of current this device produces. It involves     randomly (in no specific pattern) produced pulses of current at different times that the     brain picks up. These pulses of low current stimulate the brain in a certain way and affect     the brainwave activity.      Treatment is given by applying a low frequency current using small electrodes clipped to the     earlobes. The current comes from an external battery source. The pulses of current generated     by this device stimulate certain parts of the brain which result in a possible increased     control of attention and behaviour. This treatment has already been proven to be safe and     will not hurt your child.      Due to these specific parts of the brain being stimulated, and the positive results of     previous research, it seems possible to control certain functions in children suffering from     inattention and hyperactivity.      The idea of using tPCS stimulation as a possible way for helping children with confirmed ADHD     opens a new window to future research. The final goal of this device and research is to offer     a safe, non-invasive (conservative treatment that does not require piercing into the body or     the removal of tissue) treatment that can be used on a long-term basis and shows a clear     improvement of ADHD symptoms for children and even adults with ADHD.   "
73506|NCT02323620|"     This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its     aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived     mononuclear cells in addition to state of the art treatment is safe and reduces all-cause     mortality in patients with reduced left ventricular ejection fraction (≤45%) after successful     reperfusion for acute myocardial infarction when compared to a control group of patients     undergoing best medical care.   "
73507|NCT02323607|"     This phase I trial studies the side effects and best dose of pacritinib when given together     with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal     change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Pacritinib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as cytarabine, daunorubicin hydrochloride, and decitabine, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving pacritinib and chemotherapy     may be a better treatment for acute myeloid leukemia with FLT3 mutations.   "
73508|NCT02323594|"     Grps 1, 2, 3 This study will be testing the performance of ASV and DCV pediatric chewable     tablets.      Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg     tablet   "
73509|NCT02323581|"     Prospective, nonrandomized, single-center, single-arm feasibility and safety study to assess     the feasibility and safety of endovascular stent-graft implantation using a standard     configuration branched and fenestrated stent graft (TAAA device) or physician-specified     branched and fenestrated stent grafts (Physician-Specified TAAA Devices) for treatment of     thoracoabdominal aortic aneurysms (TAAA) involving the mesenteric and renal arteries in     patients at high risk for open surgery.   "
73510|NCT02323568|"     This project is part of a large multicenter multidisciplinary program that will thoroughly     explore the needs and difficulties of patients with BCR as well as those involved in their     care. The results of this research program will propose recommendations for better structure     and understand the follow up of these patients.      From the limited data in the literature, the long-term remission in patients with ovarian     cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as     well as somatic and mental illness; consumption is also a medical records for these patients.      In this context, our team has initiated a large case-control study to assess fatigue     (identified major problem in the long-term remission in patients with ovarian cancer), QoL     and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of     the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment,     compared with women of the same age without ovarian cancer or serious chronic disease , from     the general population.      Patients and controls complement standardized and validated self-administered questionnaire     (part 1). This study investigated 215 patients in long remission from ovarian cancer compared     to 215 women of the same age without cancer. Recruitment of patients is currently underway,     in close collaboration with teams from the Group GINECO very involved in this project.      Following this step, an additional component is planned: it is to offer patients who     participated in part 1, a specific gynecological consultation to assess in detail the effects     of the treatments in order to better meet the needs of patients .dropoff window   "
73511|NCT02323555|"     A prescription of injectable anticancer therapy requires the collection of medical data     (interview and physical examination) and often allied (laboratory tests). This requirement is     made on the day of the arrival of the patient to not prepare these treatments incorrectly.      After receiving the prescription of treatment, it will take about 1 hour to prepare for     pharmacy and more in times of high activity, to provide the day hospital pockets treatment,     incompressible time when the patient waits to have his treatment.      A process has been selected (Optima) to anticipate prescribing injectable cancer treatments     and their manufacturing to reduce patient waiting times on the day of his coming François     BaclesseCentre day hospital.   "
73512|NCT02323542|"     The present study aims at investigating the effect of ingesting 2 cereal products differing     by their SDS content on the kinetics of glucose in healthy volunteers.   "
73513|NCT02323529|"     The purpose of this study is to look at the steady-state serum concentrations of nitisinone     when switching from twice daily and once daily dosing.   "
73548|NCT02323074|"     In this project we will design a control algorithm to identify the focalized motor-related     clusters for hand function on each stroke patient. A real-time feedback will control the     robotic hand when motor imagery is successfully identified. Finally, the focalized BCI-robot     training will be compared in a randomized controlled trial to evaluate the training     effectiveness and changes in the EEG patterns.   "
79064|NCT02250963|"     This study aimed to compare dobutamine stress echocardiography (DES) with computed tomography     coronary angiography (CTCA) in patients with undergoing intermediate to high risk noncardiac     surgery.   "
73514|NCT02323516|"     The mechanisms of action of the side effects associated with targeted therapies are still     poorly understood. He was found in patients treated with gefitinib, increased levels of     thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane     A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane     synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic     properties as follows: stimulation of platelets and activation of other increased platelet     aggregation.      The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is     expressed by platelets and endothelial cells.      The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest     a role of platelet activation in the occurrence of side effects associated with targeted     therapies.      Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of     low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the     occurrence rash and diarrhea induced by gefitinib.      In this study, the group of patients treated with acetylsalicylic acid presented a lower rate     of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5     patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly,     it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the     acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in     this study, it was not revealed significant differences in terms of response to treatment     with gefitinib (37% in the standard group versus 33% in the group treated with aspirin     patient) It does not exist in our knowledge of prospective data evaluating the effect of     acetylsalicylic acid on the reduction of side effects associated with targeted in a     population of patients of Caucasian-type treatment.   "
73515|NCT02323503|"     Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF),     hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35%     and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic     function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is     associated with a significant reduction in the risk of subsequent life-threatening     ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for     defibrillator back-up after an event-free first CRT-D service-life for patients with improved     LVEF is a controversy question.      80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention     do not experience VTA during the life-time of their first device.      So, regarding patients implanted with a CRT-D for primary prevention at the time of first     implantation, the question is will they experience VTA after their device replacement by     another CRT-D.   "
73516|NCT02323490|"     This study will compare meniscal healing augmented or without augmentation with bone marrow     stimulation techniques The assessments will include validated, disease specific, patient     oriented outcome measures, second look arthroscopy during second step ACL reconstruction.     Results of this study will help ascertain whether microfractures improve meniscal healing     rates.   "
73517|NCT02323477|"     The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of     allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in     myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior     to the cell administration. This 2-year study comprise three independent groups, where the     first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and     third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will     be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will     be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of     age. The efficiency of the therapy will be evaluated according to the parameters measured by     MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6,     12, 18 and 24 months after the operation.   "
73518|NCT02323464|"     300 patients with colorectal cancer will be investigated before surgery and 60 of them will     also be investigated in the same manner after surgery. Investigations will include     polysomonographic sleep apnea recordings during one night, lung function measurements, blood     gas samples and a questionnaire, but only before surgery including questions on sleep, sleep     apnea, lung disorders.      Outcome: side effects of surgery and mortality rate, association with cancer type.      Prevalence of sleep apnea, sleep quality, hypoxemia and lung function before and after     surgery.   "
73519|NCT02323451|"     This study evaluates the safety and efficacy of investigational products in the treatment of     knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half     will receive sodium hyaluronate.   "
73520|NCT02323438|"     A single-center, randomized, controlled, switching, open-label, parallel cohort study.     Smoking subjects will be confined to a clinic for 9 days. During their stay, baseline     assessments during ad libitum smoking will occur for the first 3 days. Following baseline,     subjects will be switched to either an Electronic Cigarette or Nicotine Gum, and post-product     switch assessments will occur for 6 days.   "
73521|NCT02323425|"     The purpose of this study is to evaluate the protective effects of upper limb ischemic     postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis     and the baseline characteristics of trial participants, as an open, randomized controlled,     prospective controlled trial.   "
73522|NCT02323412|"     Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age     groups and has increased from 58 million years lived with disability (YLDs) in 1990 to 83     million YLDs in 2010. The burden is accordingly substantially higher than previously     assessed, causing activity limitation and work absence with subsequently enormous economic     burden. Norwegian expenses reach at least NOK 24 billions annually whereof a substantial part     is hospital costs. The research project responds to this challenge and aim to conduct a     multicenter randomized placebo-controlled trial, complemented by a study of epigenetic and     molecular biomarkers, to re-examine the finding of a recent randomized controlled trial that     antibiotic treatment can cure patients with chronic low back pain (LBP), a former disc     herniation and present Modic Changes (MCs). The hypothesis is that MCs is caused by low     virulent anaerobic organisms in the disc. Investigators also want to add important new     knowledge to the research field beyond the only former RCT by broadening the inclusion     criteria to include both patients with type I and type II MCs, improving the MRI assessment     of MCs, further clarifying the pathogenesis of MCs by studying genetic variability, gene and     protein expression of inflammatory biomarkers, and conducting health economic analysis.   "
73523|NCT02323399|"     The primary objective of this study is to evaluate the dose effect of Phenylephrine     Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in     the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial     anesthesia.      The secondary objectives are to describe changes in blood pressure and heart rate, time to     onset and to maximal response, and the duration of response; to assess the safety of the     product in this population; and to characterize the pharmacokinetics of phenylephrine     hydrochloride.   "
73524|NCT02323386|"     Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per     year. Statistics indicate that for patients over 60 year old approximately one out of 20 will     require corrective reoperations within 10 years after surgery. However, for patients younger     than 60 years, approximately one out of 10 will require revision total knee arthroplasty     within 10 years of surgery. As the number of younger patients is increasing, there has been a     shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and     implant longevity being the important issues for quality of patient care. Furthermore, it has     been reported that up to 25% of patients are not satisfied with the functional results of     their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However     these are often static, because of even most advanced x-ray film exchanger limit the number     of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real     time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.      The purpose of this study is to investigate the effect of a new implant design on the     post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A     prospective randomized study will be performed on a new implant: the DePuy ATTUNETM     fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.   "
73525|NCT02323373|"     This clinical trial investigated two different routes of administration of tranexamic acid in     total knee arthroplasty: topical compared to intravenous.   "
73526|NCT02323360|"     The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group     superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable     HCC treated with a TAE/TACE incomplete cycle.   "
73527|NCT02323347|"     At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program     should fresh embryo transfer (ET) be cancelled?   "
73528|NCT02323334|"     This study involves single and multiple doses of LY3202626 and will evaluate the effects of     LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single     increasing doses of LY3202626 will be given in capsule form. Part A will also include     itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B     will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days     with the study drug. Part C will last approximately 11-14 weeks. Part D will last     approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may     only enroll in one part.   "
73529|NCT02323321|"     To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts     that may not meet current standard donor heart acceptance criteria (as identified above) for     transplantation to potentially improve donor heart utilization for transplantation   "
73530|NCT02323308|"     The aim of study is to describe the clinical, immunological, serological, virological and     therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to     assess the response to vaccination in these patients.   "
73531|NCT02323295|"     This study is designed to characterize the effects of high energy radiation on bone     breakdown, with a specific interest in reducing the rate of sacral fractures. Although     radiation is very important in managing tumors, it is related to complications such as bone     fractures. In this research study, the investigators are looking to determine changes in     blood markers, bone density, and bone structure following radiation and to better understand     the reason for these changes.   "
73532|NCT02323282|"     To determine the median effective concentration of ropivacaine hydrochloride for     ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for     choosing appropriate drug concentration in clinical anesthesia.   "
73533|NCT02323269|"     The primary objective of the study is to estimate the annualized relapse rate (ARR) over a     12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are     treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching     from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as     suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the     Prescribing Physician. The secondary objectives of this study in this study population are:     To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and     health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.   "
73534|NCT02323256|"     This study aims at investigating new automatic fitting techniques for cochlear implant     patients based on objective measures. For this reason, the evolution of these     neurophysiological measures, expressing the encoding of pure tones and speech, will be     characterized in cochlear implanted patients as a function of post-implantation time and will     be compared to those of normal hearing subjects. Moreover, the effect of auditory training     with new tools based on serious games will be assessed.   "
73535|NCT02323243|"     Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of     the striated sphincter activity during voiding and characterizes the spinal cord injuries     located under the protuberance. The standard treatment for DSSD is medical, either     pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are     unable to perform CISC and require alternative surgical techniques such as external     sphincterotomy which is invasive, irreversible and with no adjustment period for the patient.      Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary     stents provide a non-definitive treatment, especially for evolutionary pathologies, for     patients refusing a destructive surgery (psychosocial impact), or for patients having not     defined yet their therapeutic preference. The Allium company has developed the  Bulbar     Urethral Stent  (BUS) system, which advantages are the possibility to perform the procedure     under local anesthesia and to remove more easily the stent, with similar performances     compared to the other devices. In order to quantify the interest of the BUS system, the     investigators propose to perform a prospective study aimed at describing its technical and     clinical results in terms of efficacy and safety.   "
73536|NCT02323230|"     This phase 2 study is designed to assess the efficacy and safety of DPX-Survivac plus low     dose cyclophosphamide in subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who     are not eligible for transplant.   "
74211|NCT02314403|"     This study will examine the safety and effectiveness of a combination kidney and bone marrow     transplant from a haplo-identical related donor. An investigational medication and other     treatments will be given prior to and after the transplant to help protect the transplanted     kidney from being attacked by the body's immune system   "
73537|NCT02323217|"     The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the     numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric     conditions such as depression and addiction, along with neurodegenerative disorders such as     Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated     functional interactions with the opioid system, where I2BS ligands have been shown to affect     tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats.     Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects     in different models of pain and a novel I2BS ligand, CR4056, is currently undergoing Phase II     clinical trials as a novel treatment for neuropathic pain and acute non- specific pain     states.      The location of I2BS on astrocytic glial cells and the possibility that they may in some way     regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS     and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been     shown to increase in Alzheimer's disease post mortem, and it has also been suggested that     I2BS may be a marker for the severity and malignancy of human glioblastomas.      The lack of suitable imaging tools for the I2BS has meant that information regarding the     number and distribution of I2BS in the brain has come from preclinical species and in vitro     post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to     quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional     distribution in the living human brain. In this study the investigators plan to utilise     [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo     using PET.   "
73538|NCT02323204|"     Children presenting to the University of Iowa Health Care System (UIHC), Blank Children's     Hospital (Blank), Children's Hospital of Minneapolis, and Kansas City Mercy Children's     Hospital with an injury resulting in admission will be the sample population. A child will be     included if they are 10-17 years old with an unintentional injury. Consenting children and     their parents will be asked to complete a series of four questionnaires: before hospital     discharge, at 1-month post discharge, 3-months and 6-months post discharge. The parent-child     dyads will be randomized (1:1) to receive 1) training in Link for Injured Kids or 2) Trauma     Education. The survey completed in the hospital will be a paper survey or online via an iPad,     and follow-up surveys can be completed on paper or online.      Aim #1: Assess the feasibility of Link for Injured Kids through qualitative research with     parents and providers of previously injured children from UI Children's Hospital.      Aim #2: Through a randomized trial, determine the range of potential psychosocial and     behavioral health indicators possibly impacted by Link for Injured Kids. This will identify     the types of outcomes which could include post-traumatic stress disorder (PTSD), depression,     nonspecific distress, quality of life, absenteeism, school performance, coping skills,     communication skills, and access to mental health.   "
73539|NCT02323191|"     This Phase 1, open-label, multicenter, global study will evaluate the safety,     pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in     participants with selected locally advanced or metastatic solid tumors that are not amenable     to standard treatment.      Participants who receive emactuzumab and atezolizumab will continue to receive study drug as     long as they experience clinical benefit in the opinion of the investigator or until     unacceptable toxicity or symptomatic deterioration attributed to disease progression as     determined by the investigator after an integrated assessment of radiographic data, biopsy     results (if available), and clinical status, or withdrawal of consent.   "
73540|NCT02323178|"     Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.   "
73541|NCT02323165|"     The primary aim is to determine if this new technique will detect and identify bacteria in     the blood sooner than standard blood cultures or identify patients who may be septic without     growing bacteria in their cultures. These will be correlated with the data collected from     medical records on presumed sepsis. These results will be linked to data concerning infection     that will be available as part of routine care including blood counts and other laboratory     values that would be part of the routine medical care such as a white blood cell count. The     earlier the bacteria are identified and the appropriate antimicrobials are administered the     better the patient outcome.   "
73542|NCT02323152|"     Postpartum depression is a disease with a prevalence of 10% which has not only deleterious     consequences for the mother but also for the baby and can delay the physical, social and     cognitive development of the baby. Therefore we consider very important to prevent this     disease as from the centers of care for women with a multidisciplinary approach. The aim of     this study is to determine whether psychoeducation oriented in problem solving is effective     in preventing the development of postpartum depression in women with very high risk.      Methodology: screening of 1000 women in 3rd trimester of pregnancy. We expect that 25% have     at least one risk factor for postpartum depression (250). Of these women, aproximately a 50%     will have a very high risk of developing postpartum depressión and will be included in the     study (n = 125). These women will be randomized to two groups: treatment with psychotherapy     focused on problem solving (6 sessions: 1 individual session + 5 group sessions) or usual     care control group (usual postpartum control).      After treatment, women will be evaluated twice, at the end of therapy and at 6 weeks.     Survival curves will be used tu assess the time it takes patients to develop major depression     in the postpartum.   "
73543|NCT02323139|"     This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients     without marrow response after at least 6 cycles of azacitidine.   "
73544|NCT02323126|"     To determine the efficacy and safety of Nivolumab in combination with EGF816 and of Nivolumab     in combination with INC280 in previously treated NSCLC patients   "
73545|NCT02323113|"     The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and     maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in patients with     relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate     preliminary efficacy of TAK-659 in relapsed or refractory AML as measured by overall response     rate (ORR).   "
73546|NCT02323100|"     We propose to test the effectiveness of the combination of CF pancreatic enzyme replacement     therapy (PERT) on absorption of Ravicti® and subsequent restoration of nasal epithelial     cystic fibrosis transmembrane conductance regulator (CFTR)-mediated chloride transport during     the nasal potential difference (NPD) test.   "
73549|NCT02323061|"     A BCI system for stroke subjects will be designed in an attempt to train the motor-related     areas in their brains responsible for hand open/close function. A robot hand will be used and     controlled by the system in real time based on EEG pattern for identification of motion     intention for hand movements in the motor cortex. A randomized controlled trial study design     will be adopted. All subjects will be assessed by clinical assessments including FMA and     neuroimaging assessments using multimodal MR techniques before and after the training to     evaluate training effectiveness.   "
73550|NCT02323048|"     The aim of the study is to extend our investigations of drug-associated conditioning with     healthy volunteers. The investigators have recently completed a pilot study demonstrating     that subjects show an increase in self-reported preference for a visual stimulus paired with     stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts     synergistically with rewards in the environment, such that this conditioning effect is     facilitated by experiencing the drug in the presence of rewarding, or positive events, such     as earning money. The investigators now aim to extend these findings by assessing not only     self-reported preference, but also attentional and psychophysiological (electromyogram; EMG)     responses to the drug-associated stimuli.   "
73551|NCT02323035|"     This investigation is designed to evaluate the at-home usability, performance, user     acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.   "
73552|NCT02323022|"     The purpose of this study is to compare the clinical efficacy and safety of IAC regimen and     IA regimen as induction chemotherapy for initial diagnosed AML patients. 840 cases are     supposed to recruited in 3 years.   "
73553|NCT02323009|"     This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome     negative transpulmonary pressure; or adjusted by use of CStat to achieve the best effective     static compliance will have any effect on outcomes with respect to ventilator weaning in     tracheotomized morbidly obese patients (BMI >=40) with at least one failed prior weaning     attempt.   "
73554|NCT02322996|"     The goal of the current study is to combine existing and new tools for quantifying patient     self-report to characterize changes in acute pain. The ability to quantitatively measure     self-report provides behavioral pain phenotypes that can serve as the basis for clustering     patients into sub-groups based on their self-report of their symptoms, eliminating observer     based perceptions of patients' pain.   "
73555|NCT02322983|"     Cerebral Palsy induces oral alterations that impact on oral health, requiring dental     treatment. The objective of this study was to evaluate the use of conscious sedation with     nitrous oxide (N2O) in the control of stress during dental treatment in individuals with     Cerebral Palsy.   "
73556|NCT02322970|"     Investigators aim to assess sensitivity and specificity of transcranial doppler in ruling out     intracranial hypertension in all patients admitted to intensive care unit for brain injury     and needing Intracranial Pressure (ICP) monitoring (according to international guidelines).     Non invasive ICP measurement through the use of transcranial doppler will be carried out     before and after standard invasive ICP monitoring placement.   "
73557|NCT02322957|"     This study is designed to evaluate the potential for a PK drug-drug interaction between     FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover     design in healthy volunteers.   "
73558|NCT02322944|"     This study aims to develop quality improvement strategies and relevant tools focusing on     reperfusion therapy in patients with STEMI, and to evaluate their effectiveness via a     hospital-level cluster randomized clinical trial, based on the nationally representative     collaborative network of over 100 hospitals established in China PEACE retrospective study.     In a baseline survey period, through consecutively recruiting all eligible inpatients and     collecting relevant medical information, the performance of all participating hospitals     before the implementation of the intervention will be assessed. During the following     intervention period, 6-10 hospitals that show the strong willingness and ability to     collaborate will be selected as process optimization group. Their clinical pathways and     team building will be re-organized for the purpose of quality improvement, and develop     individualized treatment strategies and process. Meanwhile, other participating hospitals     will be divided into intervention and control groups in a 1:1 ratio, in which the     intervention group will take the treatment improvement strategy into implementation, while     the control group will maintain the routine practice pattern. All hospitals will     consecutively recruit qualified patients in the same method adopted in baseline period. Then     the reperfusion rates and other performance measures will be compared among different groups     (process optimization, intervention and control).   "
73559|NCT02322931|"     The investigators will assess the feasibility of intraoperative use of C-arm cone-beam CT     imaging for intraoperative dosimetric evaluation in prostate low-dose-rate (LDR)     brachytherapy. Patients recruited are those who will receive standard LDR brachytherapy for     prostate cancer treatment. Consenting patients will undergo additional 3D C-arm cone-beam CT     imaging (3D C-arm) and motorized trans-rectal ultrasound (TRUS). Volumetric and dosimetric     measures will be compared to those using the standard Day-0 CT images. The investigators hope     that the intraoperative 3D C-arm provides quality assurance measures sufficient to eliminate     the need for Day-0 CT LDR brachytherapy and provide the opportunity for intraoperative     modification of seed delivery plan.   "
73560|NCT02322918|"     The purpose of this study is to determine if candidate polymorphisms in brain-derived     neurotrophic factor (BDNF) and catechol-o-methyl transferase (COMT) are predictive of     psychosis disorder severity, symptomology, and resolution in patients at BCPP. A secondary     objective will be to form a biorepository of blood and saliva samples from patients at BCPP     so that further genetic, proteonomic and pharmacogenomic studies may be done to gain insight     into the genetic basis of differences in psychosis disorder presentation and manifestation,     and differences in response to antipsychotic drug treatment.   "
73576|NCT02322697|"     Patients on chronic hemodialysis without obstructive coronary artery disease identified by     coronary angiography were randomly divided into the two groups: carnitine group and control     group. SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous     administration of L-carnitine (1000 mg on every dialysis session). Control group received the     examination of BMIPP SPECT at the same time of the carnitine group. The effects of chronic     intravenous administration of L-carnitine on myocardial fatty acid metabolism were     investigated among this population.   "
73561|NCT02322905|"     Informal caregivers of cancer patients report high levels of psychological distress as     evidenced in markedly increased levels of anxiety and depression. High levels of     psychological distress in caregivers have also been found to be associated with poorer health     and increased levels of pro-inflammatory cytokines that are well-established risk factors for     physical illness and stress-related mortality. Previous psychological interventions using     cognitive methods have only produced small effect sizes and more research on how to     effectively alleviate caregiver burden is needed. The proposed project will investigate the     effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel     approach specifically targeting emotion regulation with the aim of improving mental and     physical health. The effect of ERT will be examined in a randomized controlled trial     comparing ERT to usual medical care (UMC).   "
73562|NCT02322892|"     The main purpose of this pilot study is to test the effects of thiamine (vitamin B1)     administration before and after major cardiac surgery. Half of patients will receive thiamine     and the other half will receive placebo.      The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption     and lead to decreased levels of post-operative lactate levels and ultimately improved patient     outcomes.   "
73563|NCT02322879|"     A purpose of this protocol is to is to compare the metabolites of the toxic bioactivating     pathway after acetaminophen alone or acetaminophen followed by Propylene Glycol (PG) and to     determine if it prevents the formation of the toxic metabolites of acetaminophen.   "
73564|NCT02322866|"     To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline     compared to placebo in the treatment of moderate to severe facial acne vulgaris   "
73565|NCT02322853|"     Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the     effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor,     current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER     antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this     context of resistance, their efficacy are poor.      Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic     setting by a combination with therapy targeting signal transduction pathways. Other     transduction pathways seem to be involved in endocrine sensitivity/resistance, such as     RAS/RAF/MEK/MAK pathway.      LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of     p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein     kinase 2 (MAPKAP-K2).   "
73566|NCT02322827|"     This study is designed to see how HIV infected patients perform when taking a single fixed     dose HIV medication compared to a regimen with multiple tablets. The study is also going to     be looking at the differences in complications between the two groups.   "
73567|NCT02322814|"     This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the     safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus     placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in     Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in     participants with metastatic or locally advanced, triple-negative adenocarcinoma of the     breast who have not received prior systemic therapy for metastatic breast cancer (MBC).     Participants may continue on study treatment until the development of progressive disease     (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The     Cohort I target sample size is 12 participants for the safety run-in stage and approximately     90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety     run-in stage of approximately 15 participants followed by an expansion stage of approximately     15 participants.   "
73568|NCT02322801|"     This multi-center, observational, retrospective-prospective cohort study will investigate the     safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of     rituximab and its relative clinical impact, particularly with regard to adverse events. Data     from each patient will be collected over 24 months after enrolment in the study. Target     sample size is up to 325 patients.   "
73569|NCT02322788|"     A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way     cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared     to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced     bronchoconstriction in patients with stable, mild to moderate asthma   "
73570|NCT02322775|"     The purpose of this trial is to confirm the safety and clinical benefit of benralizumab     administration in asthma patients with mild to moderate persistent asthma in order to gain an     understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.   "
73571|NCT02322762|"     DISCOVER is a Non Interventional Study study to describe the disease management patterns and     clinical evolution over three years in type 2 diabetes mellitus patients initiating a second     line anti-diabetic treatment.   "
73572|NCT02322749|"     A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant     of selumetinib capsule are comparable, and to assess how drug levels differed in another     variant of Selumetinib in Healthy Male Volunteers.   "
73573|NCT02322736|"     The study will shed additional light on the impact of Vectibix® under the current, standard     clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the     outcomes of Vectibix® treatment in real-life setting.   "
73574|NCT02322723|"     In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient     real life setting. Moreover, the association between long-term effectiveness of Adalimumab     and patients' functional status as well as cultural aspects of sick leaves and visits to     physician's clinics has not been demonstrated in this population. This study will collect the     required data in real life settings.   "
73575|NCT02322710|"     Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in     the treatment of surgical acute wounds.   "
73577|NCT02322684|"     The purpose of this study is to assess the success rate of bougie-guided endotracheal     intubation compared to blind intubation through the Air-Q intubating laryngeal mask   "
74212|NCT02314390|"     The purpose of this study is to determine whether both group and individual mindfulness-based     cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a     chronic somatic disease.   "
73578|NCT02322671|"     This study is designed to estimate the bioavailability of montelukast from the 5 milligrams     (mg) montelukast sodium (GW483100) test formulations relative to 5 mg montelukast sodium     reference chewable tablets (innovator product). It is an open-label, randomized, single dose,     three-way cross over, six sequence study in 18 healthy human subjects. Each subject will     participate in all three treatment periods. Subjects will be randomized to one of six     sequences and administered one of the three treatments A, B or C in each treatment period,     where Treatment A is 5mg chewable tablet of reference 5 mg montelukast sodium reference     chewable tablets (innovator product), Treatment B is test formulation 1: 5mg montelukast     sodium (GW483100) chewable tablet and Treatment C is test formulation 2: 5mg montelukast     sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout     period of 7 to 14 days. Total duration in the study for each subject will be approximately 8     weeks from screening to the follow-up visit.   "
73579|NCT02322658|"     This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single     dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed     conditions.   "
73580|NCT02322645|"     This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single     dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting     conditions.   "
73581|NCT02322632|"     An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose,     crossover oral bioequivalence study in healthy subjects under fasting conditions.   "
73582|NCT02322619|"     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,     crossover, oral bioequivalence study in human subjects under fasting conditions.   "
73583|NCT02322606|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     TAK-137 in healthy male subjects.   "
73584|NCT02322593|"     The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared     with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.   "
73585|NCT02322580|"     The purpose of this study is to investigate the association between trough serum levels of     etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.   "
73586|NCT02322567|"     The purpose of this study is to examine the relationship between pre-operative LV diastolic     function and post-operative complications and kidney function in living-donor kidney     transplantation patients.   "
73587|NCT02322554|"     The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide     real world patient data from electronic health records submitted to meet Stage 2 Meaningful     Use in order to understand the value of these products among patients with chronic wounds and     ulcers. Randomized, controlled trials to establish product efficacy routinely exclude     patients with the co-morbid conditions common to patients seen in usual clinical practice and     thus the results of these RCTs tend to be non-generalizable. Little is known about the     effectiveness of CTPs among typical patients.   "
73588|NCT02322541|"     The study will consist of a single 5-day dietary treatment period. Subjects will consume an     Allium-free diet for 3 days. Alliums are vegetables such as garlic, onions, chives, shallots,     and leeks. On day 4, subjects will consume a breakfast consisting of garlic and will then     provide blood and urine samples for 10 hours, and on the following morning.   "
73589|NCT02322528|"     The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®)     on the surface of the eye and tear film (a film that coats the eye which is made up of oil     and water).   "
73590|NCT02322515|"     The relevance of this study is to determine the effects of a patellar taping on muscle     activation of the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius     (GM) during different proprioceptive exercises frequently utilized in rehabilitation program.   "
73591|NCT02322502|"     The aim of this study is first to assess if desflurane is superior in order to achieve a     faster emergence from anesthesia.   "
73592|NCT02322489|"     15 participants will be included in the present study. They will attend two groups of three     sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:        -  session 1 and 4 (performed a few days before the experimental session): session for          participants to get familiarized with the test battery.        -  session 2 and 5: experimental session (the test battery followed by the provocative          task, the test battery, the one-hour treatment and the test battery again).        -  session 3 and 6 (performed 2 days later): the test battery.      The test battery included flexibility, functional, pressure pain threshold tests.      The provocative task was an isokinetic eccentric task for knee flexors and extensors.      The treatment was either a microcurrent therapy or a placebo microcurrent therapy.   "
73593|NCT02322476|"     Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit     (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill     patients despite that clinical impact remains unknown.   "
73594|NCT02322463|"     Early and appropriate pain management in the emergency department (ED) is an important aspect     of child care. Studies in the adult population revealed that ethnicity might be associated     with disparities in analgesia and opioid treatment in ED patients suffering from limb     fractures. The investigators aim to explore if ethnicity has an influence on analgesic     practice in the pediatric ED. The objective of this study is to determine whether minority     population Arab children with orthopedic injuries are less likely than Jewish children to     receive oxycodone for limb fracture.   "
73595|NCT02322450|"     2QG1 is a Phase IIa study aiming to assess the blood pressure lowering effect of 4-week     administration of QGC001 oral doses in patients with grade I or II essential hypertension     compared to placebo, to assess the safety and tolerability, to obtain preliminary PK     information for QGC001 given as multiple oral doses and to determine preliminary PD profile     of QGC001 multiple oral doses on plasma and urine hormones, which will be compared to that of     placebo.   "
74028|NCT02316782|"     The purpose of this research study is to determine if Intravascular Ultrasound (IVUS)     grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the     location, amount, and type of a blockage than angiogram alone. Additionally, this study is to     determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term     procedural outcome vs. bifurcation stenting with only angiographic guidance in native     coronary arteries.   "
73596|NCT02322437|"     This study aims to evaluate whether psychiatric home treatment is an effective and efficient     alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of     psychiatric patients in need of hospitalization are randomly assigned to either treatment at     inpatient wards (treatment as usual) or a new care model with the additional option of     treating patients at their homes by mobile care teams. The primary focus is on checking     whether optional home treatment leads to a reduction of inpatient days during a two-year     follow-up period. In addition, the two service models will be compared regarding treatment     cost and outcomes as well as satisfaction of patients and their relatives with psychiatric     care.      Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be     examined by a highly trained clinical assessor to test and verify the diagnoses and the     clinical ratings made by the staff members of the mental hospital under routine everyday     conditions.   "
73597|NCT02322424|"     Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic     Fistula (ISGPF) is associated with a life-threatening complication after     pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors     for grade C PF by Japan and Taiwan cooperative project.   "
73598|NCT02322411|"     The overall goal of this randomized controlled pilot study is to characterize effects of     SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO)     therapy in a dose response framework on swallowing-related outcomes in a group of unilateral     ischemic stroke patients. These results will be used to determine adequate sample size in     order to support a larger clinical trial focused on the efficacy of this therapy approach for     improving swallowing safety. The first aim is to determine differences in swallowing     physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects     undergoing SwallowSTRONG® DF I-PRO therapy and controls and b) between 8 and 12 weeks of     treatment. The second aim is to examine changes in level of oral intake and swallowing     quality of life in post-stroke patients undergoing DF I-PRO therapy as compared to a control     group and as they relate to treatment duration response at 8 weeks and 12 weeks. The third     aim is to evaluate effects of DF I-PRO therapy on overall health status reflected by the     number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects     undergoing DF I-PRO therapy compared to controls.   "
73599|NCT02322398|"     The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization     (IVF) according to the type of medication used for controlled ovarian stimulation (COS). The     study compared the pregnancy rate obtained by 398 patients who had received COS with     recombinant Follicle Stimulating Hormone (rFSH) plus recombinant Luteinising Hormone (rLH) in     2:1 ratio vs. the one observed in 450 patients who had been treated with human Menopausal     Gonadotropin (hMG), stratifying results according to the number of retrieved oocytes.   "
73600|NCT02322385|"     Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA     analysis using the next generation sequencer (NGS) and examine the relationship between     mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by     Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and     non-ADPKD family members.   "
73601|NCT02322372|"     The investigators of the current study aimed to evaluate the effect of spinal anesthesia with     low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of     first analgesic requirement during postoperative period   "
73602|NCT02322359|"     Context: Chest compressions represent an important physical effort leading to fatigue and     cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest     compressions interruptions, current guidelines still recommend provider switch every 2     minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary     resuscitation remains to be assessed.      Study design: simulated prospective monocentric randomized crossover trial. Participants and     methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of     Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of     continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a     feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by     reached target of rate, depth and leaning at the same time (recorded continuously).      Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.   "
73603|NCT02322346|"     The investigators aimed to evaluate the effects of different concentrations of preincisional     peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding   "
73604|NCT02322333|"     This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects agreeing     to participate in the study and meet the entry criteria assessed at the screening visit, will     begin a 28 day baseline period to confirm their diagnosis, as well as establish baseline     migraine characteristics. During this baseline period, subjects will continue treating their     migraines as usual, simply recording the information in a daily headache diary. Subjects who,     after completing the baseline, continue to meet entrance criteria will be eligible to enter     into the treatment phase and be randomized according to the Clinvest generated randomization     schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the     treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary     assessments will collect study medication adherence, pain severity, headache symptoms, acute     medication usage, and unusual symptoms. Serum samples will be collected and analyzed for     ionized magnesium, electrolytes, and creatinine.   "
73605|NCT02322320|"     This study is designed to compare long-term outcomes among patients randomized on the BMT CTN     0702 protocol (NCT01109004), A Trial of Single Autologous Transplant with or without     Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for     Patients with Multiple Myeloma. It is hypothesized that use of novel anti-myeloma agents     will improve long-term progression-free survival (PFS) after high-dose melphalan followed by     autologous hematopoietic cell transplantation (HCT) as compared to a second autologous     transplantation.   "
74029|NCT02316769|"     In this study, the investigators compare the effectiveness of two relatively new video     laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems,     Noblesville, IN), by practitioners experienced in airway management but with limited exposure     to these two devices. Our hypothesis was that, the McGrath MAC device would require fewer     intubation attempts and shorter intubation times than the King Vision when performed by     novice users.   "
73606|NCT02322307|"     HealthPROMISE is a mobile application (app) for patients that allows regular tracking of     symptoms by patients and communicates them to physicians. The purpose of this randomized     controlled trial is to determine the impact of the HealthPROMISE application on improving     patient outcomes. The trial will look at how much patients use the application, whether     physicians change treatment in response to new information from patients, and how the     patients quality of life change over the span of the study. The investigators hypothesize     that HealthPROMISE will enhance physician-patient communication and improve clinical     outcomes.   "
73607|NCT02322294|"     This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on     glucose parameters, triglycerides and body weight as compared to a placebo. Half of the     subjects will be administered Glucodia™, while the other half will receive placebo.   "
73608|NCT02322281|"     The purpose of this study is to compare the anti-tumor efficacy of oral single-agent     rociletinib, as measured by investigator assessment of the PFS, with that of single-agent     cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure     of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet     chemotherapy.   "
73609|NCT02322268|"     The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant     therapy for type 2 Diabetes Mellitus.   "
73610|NCT02322255|"     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result     in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life     and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza     infections. Recurrent flare-ups progressively restrict movement by locking joints leading to     cumulative loss of function and disability. This 3-year, non-interventional, two-part,     natural history study is designed to gain insight into total body HO, FOP disease     progression, the impact of FOP on subjects' physical functioning, and clinical features and     biomarkers that may be useful in the diagnosis and monitoring of disease progression. This     natural history study will also provide important information to inform the design of     subsequent interventional trials.   "
73611|NCT02322242|"     A standard interscalene nerve block is performed with long acting local anesthetic     (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of     this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to     a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block     compared to ropivacaine alone for interscalene block with systemic dexamethasone.      Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a     nerve block.   "
73612|NCT02322229|"     The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin     (JETREA®) over a 6-month follow-up period.   "
73613|NCT02322216|"     The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to     olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with     allergic conjunctivitis.   "
73614|NCT02322203|"     Background:      - Niacin is a vitamin in many foods, including meats, fish, fruits, and vegetables. It is     often used as a dietary supplement that causes many improvements in the body. Researchers     think it can affect heart health.      Objective:      - To better understand the good effects of niacin supplementation on cholesterol, fat     metabolism, and vascular health.      Eligibility:      - Adults 18 years of age and older with fasting good cholesterol (HDL-C) below 60 mg/dL.      Design:        -  Participants will come to the clinic 4 times during the study.        -  They will complete a 7-day food journal before visits 1 and 3.        -  At visit 1, participants will be screened with questions about their diet and exercise,          medical history, and any drugs and vitamins they take. Vital signs and body mass index          will be measured.        -  They will have a Cardio-Ankle Vascular Index (CAVI) test of the arteries. Blood pressure          will be taken in the arms and legs and the heart will be monitored.        -  Blood will be drawn. Participants will fast for 8 12 hours before this.        -  Women will have a pregnancy test.        -  Eligible participants will get a 2-week supply of niacin. They will take 2 tablets daily          for one week, then 4 daily.        -  Visit 2 will be 2 weeks after visit 1 and the niacin dose will be increased. Visit 3          will be 16 weeks after visit 1, and participants will stop taking niacin. Visit 4 will          be 4 6 weeks after stopping niacin.        -  During study visits, participants will repeat visit 1 tests.   "
73615|NCT02322190|"     Background:      - Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD).     They always get steroids as the first treatment, but this may not work. Those people where     steroids are not enough may benefit from a treatment called extracorporeal photopheresis     (ECP). ECP exposes white blood cells to ultraviolet light outside the body. Researchers want     to study how certain markers in the blood predict the severity and outcome of acute GVHD and     how ECP treatments work for people with acute GVHD. They will also study how these markers in     the blood may help predict who should get ECP and its effects on the immune system.      <TAB>      Objectives:      - To learn more about treatments for acute GVHD after allogeneic stem cell transplantation.      Eligibility:      - Adults with acute GVHD enrolled in an NCI allogeneic transplantation protocol.      Design:        -  Transplant physicians will confirm participant eligibility.        -  Participants will receive treatment with steroids for their acute GVHD as prescribed by          their transplant physician. This will continue while they are enrolled on this study.        -  If steroids work in treating their acute GVHD, then every 28 days for 6 months,          participants will have:        -  a physical exam.        -  blood tests.        -  If steroids do not work, participants will get additional treatments as prescribed by          their transplant physician who may choose to use ECP as a part of this additional          treatment.. For ECP, blood is removed through an intravenous (IV) catheter. A machine          separates the white blood cells from the other blood parts. Those cells are treated with          methoxsalen and exposed to ultraviolet light. Then they are returned to the participant          through their IV.        -  Participants who get ECP will over at least 6 months have:        -  veins researched. They may have a catheter placed in a larger vein in the chest or          groin.        -  multiple blood tests.        -  multiple pregnancy tests (if needed).        -  multiple ECP procedures.        -  At the end of ECP treatment and 6 months after ECP, participants will have additional          physical exams and blood tests.   "
73622|NCT02322099|"     Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral     density (BMD), characterised by increases in bone turnover, which is largely limited to the     first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone turnover and     can limit loss of bone mineral density.      This study aims to determine if a short course of treatment with the oral bisphosphonate     alendronate can limit loss of bone mineral density associated with initiation of ART in HIV-1     infected, antiretroviral naive, adult subjects.   "
74030|NCT02316756|"     This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine     the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending     doses of PF-06648671 in healthy subjects.   "
74213|NCT02314377|"     Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical     intervention.   "
73616|NCT02322177|"     Background:      - People with inborn errors of metabolism can t turn food into energy the right way. This can     affect a person s growth and health. Researchers want to know how this condition affects a     pregnant woman and her baby.      Objectives:      - To collect data from the medical records of women with an inborn error of metabolism. Also,     to create a pregnancy registry of inborn errors of metabolism.      Eligibility:        -  Women with an inborn error of metabolism who either:        -  have been pregnant in the past,        -  are currently pregnant, or        -  have recently talked with their doctor about becoming pregnant.      Design:        -  This study will collect data only. No extra tests will be done.        -  Participants will be in the study for the length of their pregnancy and for 1 year after          delivery.        -  Participants will answer questions about their family s health.        -  The participant s doctor will send their medical records to researchers. These may          include data about:        -  Last health care visit before pregnancy        -  Blood, urine, ultrasound, or lab results during pregnancy        -  Delivery and recovery after delivery        -  Researchers will ask for the test(s) used to confirm pregnancy.        -  After the participant has her baby, researchers will ask for data about how the baby is          doing. This may include when the baby is sitting, walking, talking, etc.        -  The data will be placed into a database. The database will not include the participant s          name or identifying data.   "
73617|NCT02322164|"     Background:      - Researchers are studying a topical (skin) cream that reduces pain. This is called an     analgesic cream. They want to try a new test to better measure how well it works. Heat will     be applied to the participants arms and they will judge the intensity of the temperatures.     Researchers will compare the pain reduction from this cream to other pain relief treatments.      Objective:      - To better measure the effects of a pain-relieving (analgesic) cream.      Eligibility:      - Healthy volunteers ages 18 50.      Design:        -  There will be 2 study sessions.        -  Session 1 will be about 1.5 hours.             -  Participants will be screened with physical exam and urine drug test. They will               answer medical and psychological questions.             -  Participants will have sensory testing.        -  A moisturizer will be put on their arms. A heating device will be placed on their arms.          It gives heat pulses of about 2 seconds each. Some are warm and some are very hot.          Participants will say how strong each pulse is. They can move away if it gets painful.        -  Then the pain-relieving cream will be put on one arm. The moisturizer will be put on the          other. Participants will get more pulses and rate them. They will also get pairs of          pulses and compare them.        -  Some participants will return for session 2 for 1 hour. They will receive similar          sensory testing as in session 1.   "
73618|NCT02322151|"     Background:      - The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream.     These cells can be collected from donors bloodstreams and used for transplant. Studies have     shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on     these studies, it is now recommended that a nursing mother should not breastfeed from the     time she receives the first dose of the drug until 2 days after the final dose. Researchers     want to study the amount of the drug and its effect on the cells present in donor blood and     breast milk. They hope to better understand the effects of this drug on breast milk.      Objectives:      - To understand the effects of filgrastim on breast milk.      Eligibility:      - Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.      Design:        -  Participants will receive rGCSF daily for 5 days. They will have blood taken daily.        -  Participants will get a freezer bag containing 10 sterile, labeled containers for breast          milk collection.        -  Participants will transfer some of the breast milk they pump into one of the containers.          They will write the date and time the milk was collected on the container. They will          freeze the samples. Any remaining milk should be disposed of.        -  Participants will bring the samples to NIH on the day of their stem cell collection          procedure.        -  For days 1 and 2 after stem cell collection, participants will continue to collect and          freeze breast milk samples and dispose of any remaining milk.        -  For days 3 5 after stem cell collection, participants will collect and freeze samples.          They can also resume normal breastfeeding.        -  A research nurse will arrange to collect the samples.   "
73619|NCT02322138|"     The study objective is to evaluate the gastrointestinal tolerance of infant formula     supplemented with prebiotics.   "
73620|NCT02322125|"     Powered exoskeletons have emerged recently, promising to offer walking to individuals with     severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train     walking in individuals with chronic, severe spinal cord injury. We will determine the     characteristics of individuals who most benefit from such training, and identify the     neuroplasticity induced by the training. We will further determine the feasibility of the     ReWalk for home and community ambulation.   "
73621|NCT02322112|"     Too much body-fat has been linked to a low-grade inflammation throughout the body. This     inflammation is thought to then cause different diseases, like heart disease and diabetes. A     lower amount of inflammation is usually seen in people that follow a high fiber diet. A     reason for this is the microbes that live in our gut. Fiber is a main food source for these     microbes. This allows fiber to actually change the type of microbes that live in our gut.     Also, when fiber gets fermented by these microbes, health-promoting waste products get     released. We aim to determine how exactly our gut microbes contribute to the health     properties of fiber.      We hypothesize that fiber's health properties depend on how the gut microbes respond to the     fiber. To test this, we plan to add three different fibers to the diets of healthy overweight     and obese individuals for six weeks. We then will determine how the different fibers affect     an individuals' health by looking at how established markers of health change from adding the     fiber. Following this, we will see how an individual's gut microbes respond to the added     fiber. The response will be decided by looking at changes to the microbe community, as well     as their ability to ferment the fibers. By connecting health outcomes to the gut microbes'     response, we can test if the gut microbes' response to the fiber determines the fiber's     ability to effect health. If we can understand how our gut microbes respond to different     fibers and the importance of that response. Then we could personalize diets to have a greater     impact on improving health.   "
73633|NCT02321956|"     The purpose of this study is to determine whether ultrasound study of the airway to predict     endotracheal tube size in anesthetized pediatric patients better than the tube size formula   "
73623|NCT02322086|"     This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply     PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive     days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles,     scalp, facial and intertriginous sites). Biopsies of one target plaque will be collected at     baseline (at least 7 days prior to first study treatment on Day 1) and at Days 29 and 64,     with a 7-day interval between biopsy at Day 29 and commencement of application of application     of active PH-10 on Day 36. Study data from each subject will serve as an internal control     (i.e., assessment at baseline and at the end of application of PH-10 vehicle) for assessment     of clinical and cellular response to active investigational agent.   "
73624|NCT02322073|"     Visceral obesity and adipose inflammation is considered a driving force of obesity-related     systemic disease, e.g. liver cirrhosis and chronic kidney disease (CKD). Inflammatory     resolution is actively regulated by specialized pro-resolving mediators (SPMs), including the     endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of obesity-related     pathology.We hypothesize that obese patients who develop obesity-related liver and kidney     disease do so because they suffer from impaired endogenous production of pro-resolving     lipids. This will result in aggravated adipose inflammation, which causes systemic     pathologies such as kidney disease. We thus wish to investigate adipose inflammation and the     pro-resolving lipid profile of obese subjects with and without CKD and liver disease. We also     aim to investigate whether LXA4, LXB4 and other anti-inflammatory agents (such as AICAR) can     alter the phenotype of human adipose macrophages in ex vivo tissue culture.   "
73625|NCT02322060|"     In this study, the investigators used the newly developed technique i.e. in vitro activation     of dormant follicles (IVA) to promote ovarian follicle growth much more efficiently than     natural, in vivo process for women with Primary Ovarian Insufficiency (POI).Firstly, the     investigators remove one ovary under laparoscopic surgery. Then, we dissect ovarian cortex     from the ovarian medulla. The ovarian cortex is cut into small cubes and cultured with medium     containing drugs to activate dormant follicles. After 2 days of culture, the ovarian cubes     are transplanted mainly beneath the membrane of Fallopian tubes under laparoscopic surgery.     The ovarian cortex could be cryopreserve for future re-transplantation and in some cases, for     convenience to arrange second surgery. Once frozen, the ovary can be preserved     semipermanently. After transplantation, patients receive ultrasound monitoring together with     measurement of serum hormone levels for 10-12 months. If growing follicles are detected,     follicle growth is stimulated by injection of hormones (gonadotropins). Using the same ovum     pick up approach used in IVF (in vitro fertilization), we pick up oocytes from the follicles     and fertilize them. Fertilized eggs are cultured and then cryopreserved for future embryo     transfer.   "
73626|NCT02322047|"     The purpose of this study is to see whether the drugs prazosin and naltrexone will decrease     alcohol cravings and drinking in individuals who have problems with alcohol and have used     alcohol at risky levels in the past 90 days.      Prazosin is a medication that is FDA approved for treating people with high blood pressure.     Some studies have shown that prazosin may also decrease nightmares and improve sleep in     Veterans suffering from Posttraumatic Stress Disorder (PTSD). The use of prazosin for PTSD     nightmares is an off-label use. That means that the FDA has not approved prazosin for PTSD     nightmares. The current study is evaluating an off-label use of prazosin to determine     whether it is helpful in decreasing alcohol cravings and consumption among people with     alcohol problems.      Naltrexone is a medication that is FDA approved for treating alcohol problems.      This study is sponsored by the Department of Defense and the Congressionally Directed Medical     Research Program (DoD/CDMRP). We expect approximately 240 participants in this study, which     will run over approximately 4 years. Study participants will be involved in the study for 7     weeks, or until they complete the Final Assessment.   "
73627|NCT02322034|"     The investigators aim at investigating whether 24-week high intensity interval training might     exert beneficial effects by modulating neurohormonal axis in patients with chronic heart     failure (CHF). Furthermore, the effect of detraining on neurohormonal axis in CHF patients     will be evaluated.   "
73628|NCT02322021|"     This is a Phase 2 study to evaluate safety and tolerability of daily dosing with elenbecestat     (proposed international proprietary name [pINN]) (E2609) in Mild Cognitive Impairment     (MCI)/Prodromal participants and in participants with Mild to Moderate Dementia due to     Alzheimer's Disease (referred to as mild to moderate AD).   "
73629|NCT02322008|"     Can genetic markers be used to predict anti-TNF response? A cohort was established to     identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.   "
73630|NCT02321995|"     This study aims to evaluate the Zenalux IM1, an optical spectroscopy device with a pressure     sensor. The pressure sensor is intended to overcome the inconsistencies attributable to     variations in use of the device. This study will involve using the device on healthy     volunteers. Three tissue parameters will be used to analyze the pressure effects in two ways:     within- and across-subject variability. Measurements will be taken under the tongue and on     the inside of the cheek. The device is noninvasive and is approved for preclinical use.   "
73631|NCT02321982|"     The purpose of this study is to determine whether separate- versus same-day preoperative     consultation affects time to treatment (start to finish), utilization rate of Mohs, rate of     case cancellations, cost, and patient satisfaction. The investigators hypothesize that     patients with same-day preoperative consultation will have a shorter time between cancer     diagnosis and removal but, only when coordination of care is needed, longer time between     removal and consultation with other specialists, as compared to patients with separate-day     consultation. The investigators anticipate that patients with same-day preoperative     consultation will have a decrease in travel cost as compared to patients with separate-day     consultation. The investigators expect that there will be no difference in various     satisfaction matters between groups, with the exception of potentially greater convenience     reported by patients in the same-day preoperative consultation group. Finally, the     investigators hypothesize that there will be no difference between groups in regards to rates     of surgery cancellation.   "
73632|NCT02321969|"     Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on     colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of     this study is to determine the preventive effect of GTE supplements on metachronous     colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per     day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).   "
73634|NCT02321943|"     The objective of this study is to explore the longitudinal course of self-disturbances (SD)     in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a     representative sample of patients with first-episode schizophrenia, bipolar disorder and     other psychoses. The overall aim is to expand our knowledge about the role of SDs in     psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current     study is a seven year follow-up of this representative cohort, with baseline measures of SDs     and a comprehensive clinical and neurocognitive assessment battery.   "
73635|NCT02321930|"     This proposal will evaluate if musculoskeletal ultrasound (MSUS) measures or multi-biomarker     disease activity (MBDA) improve in patients treated with tofacitinib over 3 months, and     whether early MSUS measures/MBDA can predict response to therapy.   "
73636|NCT02321917|"     In this study, the investigators would like to compare a heparin-coated tubing system for     minimized extracorporeal circulation (MECC) with the conventional tubing system for MECC,     which does not contain heparin coating. The MECC system has been used since 14 years in the     investigators' hospital as an extracorporeal system to support circulation and provide oxygen     to the tissues during coronary artery bypass grafting. Until today, the investigators     performed more than 5000 MECC procedures in their department.   "
73637|NCT02321904|"     The overall aim of this study is to confirm the utility of corneal confocal microscopy (CCM)     as a new technique to rapidly and non-invasively assess diabetic neuropathy (DN) in children.     This study will be divided into two phases: Phase 1 will be a cross-sectional study of     children with type 1 diabetes and normal controls, while phase 2 will be a longitudinal     assessment of a subgroup of children with type 1 diabetes recruited during Phase 1.   "
73638|NCT02321891|"     The investigators examine the efficacy of two different transcranial direct current     stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot     study.   "
73640|NCT02321865|"     The objective of this study is to check the dose control method of NPC-02 and the holding     effect for the target serum zinc concentration in patients with zinc deficiency.   "
73641|NCT02321852|"     The purpose of this study is to investigate the effects of the eNOS activating agent     triflusal on episodic memory and cognitive functions in healthy participants.   "
73642|NCT02321839|"     To evaluate the visual outcome, number of injections and visits, and the effect of mental     status of a treat and extend regimen in managing neovascular age-related macular degeneration     with intravitreal ranibizumab.   "
73643|NCT02321826|"     The aim of this study is to determine the effect of listening to music on sleep quality     (subjective and objective), daytime dysfunction and neurophysiological arousal in patients     with insomnia.   "
73644|NCT02321813|"     The purpose of the study is to determine whether a quality of life pathway with defined     diagnostic and therapeutic options improves quality of life in colorectal cancer patients     during follow-up.   "
73645|NCT02321800|"     To determine the efficacy and safety of intravenous S-649266 in hospitalized adults with     complicated urinary tract infections caused by Gram-negative pathogens.   "
73646|NCT02321787|"     The purpose of our study is to evaluate whether utilizing ultrasound assessment during caudal     epidural injection can reliably identify unrecognized and unsuccessful nerve blocks during     the procedure, guide proper technique, and alter pain management outcome measurements for     patients.      Patients will be randomized to a group either undergoing caudal injection by a trainee using     typical techniques or by using typical techniques in addition to ultrasound for confirmation     of successful injection. The patients enrolled in this study will have the same     intraoperative care, in line with the standard of care. Data will be collected     intraoperatively and postoperatively on pain scores, time for performance of caudal block,     and perceived success of the block. There will be no direct benefit to the patients enrolled     in this study, but future patients may benefit from the use of ultrasound for the     confirmation of a successful block.   "
73647|NCT02321774|"     Monitor stress response in a virtual reality environment using a wearable sensor to analyze     and track heart rate variability (HRV).   "
73648|NCT02321761|"     Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who     suffered Acquired Brain Injury in order to expedite recovery and improve functioning.      A previous study examined the spatially asymmetric allocation of attention in patients with     traumatic brain injury (TBI). Patients demonstrated significantly worse performance with     leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of     neglect patients. This difference was significantly reduced during and following treatment.     Our objective is to investigate whether Amantadine Hydrochloride is effective in improving     allocation of spatial attention and improving function in people with Traumatic Brain Injury.   "
73649|NCT02321748|"     CYP2C8 is involved in the metabolism of many drugs. So, it is important to assess in vivo the     inhibitory effect of ASP2151 on that enzyme to determine any possible drug interactions. The     aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2C8     probe substrate montelukast.   "
73659|NCT02321618|"     African-American men suffer more than most other groups from hypertension (HTN) but often     have less access and less contact with doctors. Previous work by the study's Principal     Investigator in Dallas, Texas, and Altadena, California, showed that barbershops are an     excellent place to identify black men with high blood pressure and to enlist the aid of their     barbers as healthcare extenders.      The purpose of this study in Metro Los Angeles (LA) is to compare two types of barber-based     patient-centered blood pressure programs to see which type is more effective in improving the     customers' high blood pressure. One type emphasizes blood pressure medication and the other     type emphasizes lifestyle modification for high blood pressure.   "
73660|NCT02321605|"     This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible     Self) over optimism, future expectancies and positive affect at mid-term, in comparison to a     control group. The principal hypothesis is that Best Possible Self intervention will enhance     significantly the levels of optimism and positive affect in comparison to the control group     at short and mid-term.   "
73907|NCT02318368|"     Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and     safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with     previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.   "
73650|NCT02321735|"     : Stages III and IV serum ovarian cancer are the most lethal of all gynecologic cancers;     however, some advanced-stage ovarian cancer patients are long-term survivors. These patients     may provide the key to long-term survival and bring hope to all women with Stages III and IV     ovarian cancer. There is no meaningful explanation of why some patients with ovarian cancer     become long-term survivors and what their quality of life is long after their initial     diagnosis. This research project will specifically determine molecular features within tumors     along with genetic, quality of life, and lifestyle features that predict for long-term     survival for patients with Stages III and IV ovarian cancer. It will bring together     sophisticated molecular techniques, researchers with longstanding interest, a wide spectrum     of consumer advocates (a number being long-term survivors), and quality of life experts to     analyze the most carefully maintained patient database in the world—the Gynecologic Oncology     Group database. We anticipate the results from this project will identify specific     biochemical pathways and genetic features associated with long-term survival that can be used     to improve the treatment, survival, and survivorship of patients with this disease. There is     clearly something unique among patients who survive Stage III or IV ovarian cancer long term,     and we believe that when we understand what this is, we can increase the number of long- and     longer-term survivors.   "
73651|NCT02321722|"     Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed     and treated properly. The major risk factor for the development and progression of glaucoma     is increased intraocular pressure. Colonoscopy is one of the most preformed world wide     screening exam. It is used to detect colon cancer at its early stages. As part of this     examination, the examiner inflates the inspected colon with air in order to increase the     colon lumen for better visualization of the colon. As a consequence of the insufflation the     intrabdominal pressure increases as well. the increase in intrabdominal pressure could     increase intraocular pressure. The aim of this study is to evaluate the intraocular pressure     increase while preforming colonoscopy.   "
73652|NCT02321709|"     Primary Objective:      To assess the tolerability and safety of SAR113244 in male and female lupus patients after     every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.      Secondary Objectives:      To assess in male and female lupus patients:        -  The pharmacokinetics of SAR113244.        -  The pharmacodynamics of SAR113244 for the following disease-related parameters:             -  Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus               Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus               Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus               Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index               (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of               Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic acid               antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma               complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive               protein.             -  Peripheral blood B and T cells subsets.   "
73653|NCT02321696|"     Work-related upper extremity disorders are common problems in working populations in western     countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft     tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000     patients in general practice, and as high as 15 % of workers in highly repetitive hand task     industries.      LE is a painful condition, leading to loss of function of the affected limb. Therefore it can     have a major impact on the patient's work and personal life. If untreated, it persists for an     average of six to 24 months and associated with significant sickness absence in 5 % of     affected working-aged adults. The cost is therefore high, both in terms of loss of     productivity and health care utilization.      Many treatments have been advocated in the management of LE, possibly implying that much is     unknown about its etiology and how it best should be treated. Systematic reviews have failed     to draw any firm conclusions as to what treatment is most effective in managing this     condition.      Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both     clinicians and consumers of health, and there is some evidence suggesting that acupuncture     treatment is effective in of acute symptoms in LE. A recent study supports that also elbow     manipulation have a short-term relief of acute symptoms in LE, especially when combined with     eccentric exercise. Our study will therefore explore the clinical effectiveness of     physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.   "
73654|NCT02321683|"     The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on     cement-less femoral stems.   "
73655|NCT02321670|"     A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and     primary anastomosis or with an onlay grafting procedure using buccal mucosa.   "
73656|NCT02321657|"     RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an     iPad app with art, music and games to relax and distract children, reduce anaesthetic     induction time and make drug cost savings prior to surgery.   "
73657|NCT02321644|"     This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of     multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics of     single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the     minimum amount of UV-B light that causes minimally perceptible skin reddening. This will take     place before dosing (baseline) and 3 times more while on increasing doses of CC-90001. Punch     biopsies of the exposed areas will be taken and assessed for c-Jun terminal kinase activity.     Part 2 involves evaluation of changes in pharmacokinetics of 2 formulations of CC-90001 when     administered in the fasted state and after a high-fat meal.   "
73658|NCT02321631|"     The purpose of this study is to study the effects of EPA-enriched supplement compared with     conventional supplement in malnourished head and neck cancer patients undergone surgery.     Primary outcome is perioperative weight changing.   "
73661|NCT02321592|"     The study is designed        -  to demonstrate efficacy of AFM13 with an optimized treatment schedule        -  to decide whether AFM13 warrants further investigation in a phase III clinical trial   "
74031|NCT02316743|"     The purpose of this study is to determine whether levothyroxine supplementation is beneficial     in patients with systolic heart failure and subclinical hypothyroidism on the functional     class evaluated with a 6 minute walk test.   "
73662|NCT02321579|"     This study is designed as a hospital-based cross-sectional and randomized placebo-controlled     intervention trial. One hundred and fifty patients with either cirrhosis or cirrhosis     combined with hepatocellular carcinoma (HCC) who meet the inclusion criteria will be     recruited from Taichung General Veterans Hospital. One hundred patients will be randomly     assigned to either the 1) placebo group (n = 25); 2) vitamin B-6 group; (50 mg/d, n = 25); 3)     glutathione (GSH) group (500 mg/d, n = 25); or 4) vitamin B-6 (50 mg/d) plus GSH (500 mg/d)     group (n = 25) for 3 mo. Data on demography, anthropometry and medical history will be     collected. Patients with cirrhosis or cirrhosis combined with HCC will have fasting blood     drawn in the clinics. Additionally, patients who participated in the intervention study will     have blood drawn at month 0, 1, 2 and 3 during intervention period. Hematological     measurements, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine,     SAM, SAH, oxidative stress indicator, oxidized GSH and GSH related antioxidant enzyme     activities will be analyzed.   "
73663|NCT02321566|"     This study is an open-label study to determine the feasibility of Motor Cortex Stimulation     (MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS will     be delivered by use of an electrode and pulse generator, which are FDA approved for spinal     cord stimulation but are not approved for MCS. The study has as a single-arm design with the     subject at baseline serving as a control for the response to MCS.   "
73664|NCT02321553|"     The purpose of the study is to determine the effect of consumption of brown rice on the risk     factors of metabolic syndrome (MetS) as compared to consumption of white rice. Brown and     white rice will be provided in the form of rice cakes and 100g will be consumed per day for 5     weeks each. The investigators hypothesize that brown rice will have beneficial effects as it     is rich in fiber and also phytochemicals.   "
73665|NCT02321540|"     The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica)     ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of     Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1     can help to control the disease.      The safety of this drug will also be studied in both parts of the study.   "
73666|NCT02321527|"     The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON     (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery.     Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the     first node that may be the target of cancer cells that spread from the tumor.   "
73667|NCT02321514|"     The purpose of this study is to generate initial insights into the safety and performance of     the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral     regurgitation who are not suitable candidates for conventional mitral valve repair or     replacement. The study will include up to 110 subjects at up to 30 centers. Follow-up     evaluations will be conducted through 2 years post implantation.   "
73668|NCT02321501|"     The goal of this clinical research study is to find the highest tolerable dose of ceritinib     (LDK378) and everolimus that can be given to patients with NSCLC or head and neck cancer. The     safety of the drug combination will also be tested.   "
73669|NCT02321475|"     The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian     patients of middle age and younger, suffering from psycho-emotional symptoms added to     cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood     test) score.   "
73670|NCT02321462|"     The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the     reference colonic lavage in Russia) administered in adult subjects scheduled to undergo     colonoscopy for a routinely accepted diagnostic indication.   "
73671|NCT02321449|"     To evaluate the effectiveness of treatment with Circadin based on sleep improvement as     assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and     after the treatment   "
73672|NCT02321436|"     The purpose of this study is to investigate if early administration (i.e. within 12 weeks     after stroke) of Dysport® 500 U injections may delay the appearance or the progression of     upper limb symptomatic spasticity.   "
73673|NCT02321423|"     International Pachyonychia Congenita Research Registry (IPCRR) is a patient registry for     those suffering from Pachyonychia Congenita (PC). PC is an ultra-rare extremely painful skin     disorder that causes painful blisters and callus on feet and sometimes hands, thickened     nails, cysts and other features. The IPCRR consists of a questionnaire, patient photos,     physician notes from telephone consultation to validate questionnaire, free genetic testing.   "
73674|NCT02321410|"     Atherosclerosis may initiate early in life and takes years to progress. This contrasts to the     abrupt coronary or cerebrovascular events occurring following the transition from a stable to     an unstable atherosclerotic plaque. The causes of this discontinuity of the disease are     complex and probably multiple. There is increasing evidence that, besides inflammation,     neovascularisation of atherosclerotic plaques and intra-plaque hemorrhages play an important     role in plaque instability ending-up frequently in acute thrombotic occlusion or distal     embolisation of athero-thrombotic material associated with heart attack or stroke.     Contrast-enhanced Ultrasound, is a bed-side non-invasive technique, which allows to enhance     microvascular structures and to visualize the adventitia and intraplaque vascularization.     Dynamic contrast-enhanced plaque MRI (DCE-MRI) which has also been evaluated for in vivo     detection and quantification of plaque neovascularity. Together with the presence of a large     lipid-rich core, thin fibrous cap, positive remodeling and active inflammatory infiltrate,     plaque neovascularisation is considered a valid marker of high-risk (or vulnerable) plaque as     demonstrated in histopathological studies using microvessel density.      Aim of the study is to assess and validate the value of contrast enhanced ultrasound (CEUS),     a bed-side technique, in detecting plaque neovascularisation and compare it with the     quantitative assessment by DCE-MRI in carotis atherosclerosis.      A group of 30 patients with asymptomatic carotid atherosclerosis (> 50% stenosis on Doppler     ultrasound) will undergo Carotid Duplex ultrasounds and CEUS. High-resolution plaque MRI and     DCE-MRI will be performed in the same patients and will be analyzed by two separate operators     blinded to the results of the CEUS in order to detect the efficacy of CEUS when compared with     in vivo DCE-MRI, as the standard of reference.   "
73675|NCT02321397|"     This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR     tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same     overall daily dose.   "
73699|NCT02321085|"     Prospective randomized (rhythm control or rate control in heart failure patients with new     onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients     with heart failure with new onset atrial fibrillation according to the rhythm control 2. To     analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3.     To analyze the change of LV function and functional capacity according to the rhythm in     patients with HF and new onset AF   "
73676|NCT02321384|"     This study is a single-center, double-blind, randomized, placebo-controlled, single-ascending     dose (SAD) and multiple-ascending dose (MAD) study that will evaluate the safety,     tolerability and pharmacokinetics (PK) of RO6889678 and the combination of RO6889678 with     Ritonavir (RTV) following oral administration in healthy volunteers. The effect of food on     the PK of RO6889678 and the effect of multiple dosing of RO6889678 and the combination of     RO6889678 with RTV on the PK of a single oral microdose of midazolam will be evaluated.      Healthy participants will be screened up to 28 days before randomization and sequentially     enrolled into SAD and MAD unboosted and RTV-boosted cohorts, then randomly assigned to     RO6889678 or matching placebo. In RTV-boosted cohorts participants will take RO6889678 in     combination with RTV. To explore the effect of food on RO6889678 PK, a cohort of volunteers     will participate in a two-period food effect sub-study. Participants enrolled in the MAD     cohorts will be given an oral microdose of midazolam before and after the repeat treatment     with RO6889678 to evaluate the drug-drug interaction potential of RO6889678.   "
73677|NCT02321371|"     In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE     (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the     fulfilment of inclusion/exclusion criteria and consent of the patient's attendants.     Investigation of the patient (as mentioned in the proforma) will be done.      Intervention step 1:      liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema 3rd     hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly (If     patient has no bowel sounds, only enema will be given)      Intervention step 2:      (after 24 hours of introduction of step 1, if no rapid reduction in ammonia to <70mcg/dL)     Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose +     addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only)     Continuation of Lactulose therapy for further 48 hours.   "
73678|NCT02321358|"     This trial is a three-armed randomized controlled trial which will explore the utility of an     implementation intention intervention on aerobic and resistance exercise in older (60+)     prostate and breast cancer survivors and improving quality of life. It is expected that those     in the experimental groups will report greater increases in their physical activity,     resulting in greater improvements in their quality of life.   "
73679|NCT02321345|"     This is a feasibility study of pre-transplant involvement of a palliative care provider in     the setting of HCT. Although this is primarily a feasibility pilot, the investigators will     explore how patients are affected by the palliative care meetings as well as test data     collection mechanisms that would be used in a future randomized clinical trial.      The investigators hypothesis is that patients will be amenable to pre-transplant involvement     of the palliative care team and might welcome the chance to discuss palliative care issues     separate from the primary team. Palliative care providers also have special training and     experience in conducting these interactions and expertise in supportive care practices. They     will be available should a patient's condition become life- threatening. This study is     therefore designed primarily to evaluate the level of comfort / distress of patients when a     palliative care consultation and follow-up are integrated into their care.   "
73680|NCT02321332|"     Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic     sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory     hyperhidrosis.   "
73681|NCT02321319|"     This pediatric study is designed to provide safety information, dosing guidelines, and a     pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl)     extended-release (ER) tablets in children with chronic painful conditions who are     opioid-tolerant prior to enrollment under the Pediatric Research Equity Act (PREA) of 2003.   "
73682|NCT02321306|"     Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to     evaluate the long-term safety and tolerability of daily dosing with LUM001.   "
73683|NCT02321293|"     The purpose of this study is is to assess the safety and tolerability of curcumin in     combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR     NSCLC.   "
73684|NCT02321280|"     Denosumab, a fully human monoclonal antibody to RANKL was approved for the treatment of     postmenopausal osteoporosis in June 2010. It is administered subcutaneously once every 6     months and is highly effective in reducing the risk of vertebral, non-vertebral, and hip     fracture risk. There are 3 main concepts underpinning the rationale for using Denosumab to     treat CD.        1. CD is associated with an increased risk for osteoporosis and the biology of osteoporosis          and T cell mediated inflammation, thought to be integral in CD, involve the RANKL          paradigm        2. Animal models of bone loss and colitis treated with RANKL inhibitors improve both bone          mass and colitis. A dinitrofluorobenzene sulfonic acid (DNBS) model of colitis in our          lab showed significant improvement with Denosumab treatment compared to vehicle (saline)          treatment.        3. CD is associated with an increase in mutations at the locus that encodes for RANKL The          investigators are conducting an open label pilot study of single dose Denosumab 120 mg          s.c. to patients with active Crohn's disease, with assessment of clinical response and          remission at 12 weeks.   "
73685|NCT02321267|"     Macular diseases often cases severe visual impairment. Recent clinical introduction of     anti-vascular endothelial growth factor agents may change the clinical course of various     macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal     vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy     (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic     macular edema (DME), and so forth. The advance in vitrectomy improve visual outcomes in some     maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular     traction syndrome (VMTS).      Patients with such macular diseases are registered and are followed up for 5 years with     appropriate treatment for each patient. By the analysis of the correlation between initial     examinations and final visual acuity, factors associated with good visual prognosis will be     elucidated.   "
73725|NCT02320747|"     Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential     movements, providing a smooth, continuous and low intensity activity. It has been promoted to     improve balance and strength and to reduce falls in the elderly, especially those 'at risk'.     The potential benefits in healthy younger age cohorts and for wider aspects of health have     received less attention.      The present study documented prospective changes in balance and vascular responses for a     community sample of adults.   "
73686|NCT02321254|"     The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to     determine the feasibility of including robotic therapy in daily rehabilitation programmes,     after stroke. Additionally, we aim to investigate the acceptance of this intervention from     patients and therapists. A total of 10 patients will be recruited in this study, all the     patients will receive 1 hour of standard therapy together with 45 min of robot therapy every     day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period     of four weeks. Additional 15 minutes are required for placing surface electrodes on the     shoulder and patient preparation. The study will include passive and active shoulder training     of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external     rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35     minutes.   "
73687|NCT02321241|"     The aim of the TITAN study is to describe the clinical practices of a cohort of patients with     wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who     switch to aflibercept after less than 12 months of ranibizumab treatment.      The study will be conducted in real-life conditions and will allow describing conditions of     use of aflibercept in patients refractory to ranibizumab   "
73688|NCT02321228|"     The purpose of this study is to determine whether an innovative preventive strategy,     consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy     beyond current guideline age, improves menopause-related quality of life without     significantly increasing ovarian cancer incidence in comparison to current standard     salpingo-oophorectomy in female BRCA1/2 mutation carriers.   "
73689|NCT02321215|"     The purpose of this study is to determine if it is effective and feasible to provide a     chronic obstructive pulmonary disease (COPD) education program to patients admitted with an     acute exacerbation of COPD.   "
73690|NCT02321202|"     The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy     is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition     improved postoperative recovery for cirrhotic patients with liver cancer underwent     hepatectomy..   "
73691|NCT02321189|"     Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal     thickness of the young participant using SD-OCT to see the effect of Resveratrol Based     Nutritional Supplement on Choroidal Thickness.   "
73692|NCT02321176|"     There is blood-eye barrier in eyes,but some oral medicines can enter in the tissues of eyes.      The primary objective of the study is to study the Pharmacokinetics of Trans-resveratrol and     Its three Metabolites in Human Eyes and Blood   "
73693|NCT02321163|"     Objectives: This study aims to examine the use of low frequency (2Hz), low amplitude     (intensity just produce visible muscle contraction), and long duration (2x3 hrs/day)     neuromuscular electrical simulation (NMES) in attenuating the effects of muscle atrophy     resulted from disuse.      Design and subjects: The study is a randomized, double-blind, controlled, and parallel group     study. Subjects with stable chronic obstructive pulmonary disease (COPD) will be included.     Intervention: Subjects will be randomized to 3 groups to receive different NMES program over     the quadriceps and calf muscles: (i) the proposed NMES program; (ii) conventional NMES     program (50Hz, 30 min/day), or sham group for a period of 8 weeks.      Outcome measures:The effectiveness of the NMES will be evaluated by the improvement in muscle     cross-sectional area (CSA), muscle performance (muscle strength, muscle shortening velocity     and muscle activation testing), functional performance (6 min walk) and subjects' rating of     the perceived acceptability of the stimulation protocol.      Data analysis: Baseline characteristics of the intervention and sham groups will be compared     using one way ANOVA. Two-way mixed repeated measures analysis of variance will be performed     to examine the differences between groups over time for all the outcome variables. The     significance level is set at p < 0.05.      Expected results: The investigators hypothesize that the proposed new paradigm of NMES would     be more effective in improving muscle cross-sectional area (CSA), strength, endurance, and     exercise tolerance.   "
73694|NCT02321150|"     The aim of this study is to introduce a new surgical technique for the removal of pterygiums     that entails the use of bipolar electrocautery to secure the graft, rather than sutures.      With this, the objective is to evaluate the benefits of a new technique for pterygium surgery     with respect to postoperative patient comfort, surgery time, cost and recurrence rate.   "
73695|NCT02321137|"     The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical     closure of LAA in patients undergoing aortic valve replacement. This randomized, prospective,     open-label international multicenter trial will enroll 1040 patients undergoing aortic valve     replacement with CHA2DS2-VASC score ≥2 but without an indication for anticoagulation at the     time of enrollment. Patients will be randomized in 1:1 fashion to standard therapy + surgical     closure of LAA vs. standard therapy alone. The duration of the study is five years (plus     additional 10 years).   "
73696|NCT02321124|"     Connective tissue manipulation (CTM) is a manual reflex therapy, which increases intestinal     motility by stimulating autonomic nervous system to re-balance the parasympathetic and     sympathetic functions. However, there is no randomized controlled trial (RCT) regarding the     efficacy of CTM on constipation. This study was planned to investigate the effects of CTM in     patients with chronic constipation.      Patients who have diagnosis of chronic constipation according to Rome III criteria were     recruited and randomized to intervention and control group. The intervention group received     CTM in addition to the lifestyle advice, while the control group was given only lifestyle     advice for constipation. All assessments were performed at baseline and at the end of 4     weeks. The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary     outcomes included Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL),     Bristol Stool Scale (BSS) and 7-day bowel diary. Differences between groups were analyzed     with t-tests, Mann-Whitney U test and Chi-square test.   "
73697|NCT02321111|"     The purpose of this study is to determine whether pharmacologic inhibition of Toll-like     receptor 4 (TLR4) with eritoran for injection (E5564) prevents lipid-induced insulin     resistance in lean, normal glucose tolerant (NGT) subjects.   "
73698|NCT02321098|"     The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail     Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment     of mild to moderate toenail Distal Subungual Onychomycosis.      The second objective of this study will be photographic follow-up of clinical improvement and     cure after the initial treatment period of 12 weeks, for 15 additional months.   "
73700|NCT02321072|"     Objectives:        1. To study the short- and long-term effect of two different PaO2 targets on circulatory          status, organ dysfunction and outcome in patient admitted to the ICU with Systemic          Inflammatory Response Syndrome (SIRS) criteria.        2. To study underlying mechanisms of hyperoxia by determining differences in oxidative          stress response between the hyperoxic and the normoxic patients.      Study design:      Randomized, prospective multicentre clinical trial      Study population:      Patients admitted to the Intensive Care unit with ≥ 2 positive SIRS-criteria and an expected     ICU stay of more than 48 hours      Intervention:      Group 1: target PaO2 120 (105 - 135) mmHg (high-normal)      Group 2: target PaO2 75 (60 - 90) mmHg (low-normal)      Primary endpoints:      The primary endpoint will be cumulative daily delta SOFA score (CDDS) from day 1 to day 14.   "
73701|NCT02321059|"     Patients with an incisional hernia in the midline and controls with an intact abdominal wall     are examined twice with one week apart, in order to establish the test-retest reliability and     internal and external validity of the Goodstrength trunk dynamometer.   "
73702|NCT02321046|"     This is a multicentre, non-interventional, prospective study to be carried out in     representative oncology departments / institutions in order to determine the prevalence of     EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC     in Russia.   "
73703|NCT02321033|"     Aim of the study is to investigate the impact of glycemic index (provided as soft drinks) on     changes in insulin sensitivity, metabolic flexibility, and arterial stiffness in response to     detraining.      The investigators hypothesize that low glycemic soft drinks decrease the detraining-induced     impairment of insulin sensitivity, metabolic flexibility and arterial stiffness.   "
73704|NCT02321020|"     The present study aimed at evaluating mid-term results of radiofrequency modified maze     procedure in mitral patients in terms of sinus rhythm and atrial contractility restoration   "
73706|NCT02320994|"     In this first step of the study the investigators will assess the needs, disease burden and     current treatments of long-term stroke patients (phase MAS-I).      The ultimate aim of the complete MAS project (MAS I, II & III) is the development of a model     of stroke aftercare delivery that can be evaluated to estimate effects in both our local and     the wider stroke population.   "
73707|NCT02320981|"     Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower     esophageal impedance measurements when compared to patients who do not have GERD or EE.   "
73708|NCT02320968|"     This study is designed to determine if the addition of the MedclineTM Sleep Assist Device     will decrease night-time gastroesophageal reflux disease events.   "
73709|NCT02320955|"     The complications after reimplantation of cryoconserved autologous bone flaps are reported     inhomogeniously in the literature. Especially the incidence of bone flap resorption varies     from 0% to about 30%. More recent retrospective studies seem to find higher resorption rates     and thus suggest to implant artificial bone replacements from the start. The Swiss     Prospective Autologous bone Resorption Study is the first propspective observational study     designed to determine the true incidence of autologous bone resorption.   "
73710|NCT02320942|"     This study is a preliminary study to assess whether it is possible to introduce an exercise     program for BMT patients after discharge from hospital. The exercise program will include 3     endurance (stationary bike, walking) and 2 resistance (weights, stretch bands) training     sessions/week, until 100 days after BMT. Our second plan is to test changes in QoL, aerobic     fitness, muscle strength, total body fat and mineral composition, and blood immune markers     with exercise in the 100 days after BMT. The investigators anticipate this study will improve     the QoL, mobility, and strength of patients after BMT, therefore allowing a faster and     healthier recovery.   "
73711|NCT02320929|"     This study evaluates the effect of postoperative intermittent closed-catheter irrigation on     the recovery from the purulent flexor tenosynovitis. One group of patients suffering from     acute purulent flexor tenosynovitis is treated using intraoperative irrigation only and the     other group having both intra- and postoperative irrigation.   "
73712|NCT02320916|"     Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas     exchange. However, arterial punctures are more painful than venous punctures and, in ICU     patients, cause greater anxiety than tracheal aspiration. The only technique that has been     shown to effectively reduce pain during arterial punctures is the subcutaneous injection of     lidocaine. However, this technique is more time consuming and is poorly used.      Topical anesthesia is widely used during arterial punctures despite the lack of proof of     efficacy.      While performing arterial punctures with small gauge needles is feasible, to the best of the     investigators knowledge no studies have assessed the effect of needle gauge on arterial     puncture related pain.      The aim of the present study was to compare the pain experienced during arterial punctures     performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of     the pain and the anxiety associated with the arterial punctures.   "
73726|NCT02320734|"     Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure     where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia     conditions. Under these conditions, boluses of muscle relaxants can be given on indication     only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of     rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia     conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex     are needed to reverse NMB at the end of surgery.      Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on     indication only on surgical and anesthesia conditions in patients for endoscopic esophageal     resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed     in both groups in an economical perspective and to compare the intra-operative cardiac and     respiratory incidents and post-operative complication rate of both groups.      Study design: a single-center randomized controlled double-blinded intervention study.      Study population: All patients > 18 years to undergo a thoracolaparoscopic esophageal     resection.I Intervention: Patients are randomized to receive either continuous infusion of     rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group     2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.      Main study parameters/endpoints: The primary outcome parameter of this study is the SRS     during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes     measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose     of Sugammadex needed in both groups to reach a TOF of > 90%, duration of surgery, a     cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the     ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.   "
73908|NCT02318355|"     This study is a randomized control trial in volunteer blood donors to quantify the effect of     blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation     such as base deficit and lactate.   "
75457|NCT02298127|"     The purpose of this study is to evaluate the potential efficacy of auricular acupressure to     stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal     symptoms among attendees in primary healthcare settings.   "
73713|NCT02320903|"     The goal of the current trial is to assess the feasibility of a newly developed prototype of     a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes     of youth with externalizing behavioral problems by improving parental monitoring of youth     whereabouts and activities while increasing the delivery of rewards to teens for good     behavior. This Phase I Small Business Innovation Research (SBIR) proposal seeks to develop     and conduct initial feasibility testing of the VillageWhere prototype. The primary features     of the prototype include location monitoring via smartphones' global positioning system (GPS)     functionality as well as facilitating teen self-appraisal of meeting behavioral expectations.     Good behavior is rewarded with points that are tracked by the app and can be used to redeem     for real-world rewards. The investigators will conduct an 45-day open trial (N=20     caregiver/teen dyads) to assess use, feasibility and acceptability for teens involved in the     juvenile justice system or otherwise struggling with externalizing behavioral problems.     Caregivers and teens will be assessed at baseline, before receiving the app, and at the end     of the app use period (45 days). The therapist of each caregiver/teen dyad will also be     assessed at the end of the app use period. Primary outcomes include: use of app features,     monitoring of teen behavior and whereabouts, delivery of real-world rewards, and feasibility     and acceptability. Secondary outcomes include: parenting behaviors, externalizing teen     behaviors and internalizing teen behaviors.   "
73714|NCT02320890|"     The primary objective of this study is to investigate whether the transcranial direct current     stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment     (MCI)   "
73715|NCT02320877|"     In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep     apnea (OSA) (AHI > 15/h sleep) will be included and treated with mandibular advancement     devices (MAD). These patients will undergo cardiovascular examination; echocardiography and     24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients.     These cardiovascular examinations will take place before and during MAD therapy.   "
73716|NCT02320864|"     To evaluate operational aspects of studying pre to post surgery/hospitalization changes in     the integrity of a major white matter pathways and how these contribute to reductions in the     ability to produce forceful muscle contractions.   "
73717|NCT02320851|"     The purpose of this study is to evaluate the efficacy of a manualised, multimodal group     psychotherapy, based on integrative psychotherapy (IPT) and tailored to somatoform     vertigo/dizziness (SVD) subgroups of mental disorders, compared to self-help groups (SHGs) in     patients with SVD. The investigators hypothesise that patients who received IPT will     demonstrate greater improvement concerning their vertigo-related handicap compared to     patients from the SHGs. The investigators will also analyse the cost-effectiveness of     experimental and control intervention.   "
73718|NCT02320838|"     The purpose of this study is to determine whether the transcutaneous application of     unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal     and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover     evidence whether the effect and comfort of this current is greater than Conventional TENS     (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical     pain.   "
73719|NCT02320825|"     The purpose of this study is to find out whether giving one higher dose of radiation is as     good at treating the tumor in the patient's spine after surgery as giving three lower doses     of radiation.   "
73720|NCT02320812|"     This study evaluates the safety and potential activity of a single dose of live human retinal     progenitor cells (jCell) administered to adults with retinitis pigmentosa. Two different dose     levels of cells will be assessed in each of two groups of patients.   "
73721|NCT02320799|"     The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of     HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence.     This pilot study will provide data on the efficacy trends, acceptability and feasibility of     our IPT intervention and will generate preliminary findings for an R01-funded intervention to     test the intervention's efficacy for remediating the effects of GBV trauma on mental health     and HIV-related outcomes.      Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU     alone.      Hypothesis 2: IPT+TAU will be acceptable and feasible.   "
73722|NCT02320786|"     Losing the ability to walk can lead to fewer opportunities to socialize with friends and     family and participate in the community. When this happens, powered wheelchairs can provide     access to homes and communities, contributing to health and well-being. Training by a     qualified occupational therapist allows an individual to use a powered wheelchair safely and     effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time     consuming for people with cognitive and physical challenges. In this study, we will ask     participants with cognitive impairments to complete training with an occupational therapist     using either a shared control wheelchair or training methods according to the standard of     care. We believe shared control training, entitled Collaborative Powered mobility Innovative     Learning OpporTunity (CoPILOT) will enhance driving skill while maximizing safety learning.     CoPILOT has the potential to enable people to participate more in their day to day lives and     regain mobility independence.   "
73723|NCT02320773|"     A study to understand the impact of Betmiga® on patients quality of life, satisfaction with     treatment, how long patients remain on treatment, patterns of healthcare resource     utilisation, and safety as prescribed by the physicians in routine clinical practice.   "
73724|NCT02320760|"     This randomized controlled study evaluates the effect of individualized physical activity on     prescription (PAP) in older overweight adults. The primary hypothesis is that an     individualized prescription of physical activity increases physical activity level in     overweight older adults after 6 months. Secondary hypothesis are that the increased physical     activity level will improve cardio metabolic risk factors and quality of life.      200 women and men, aged 65 with low physical activity level, overweight, and abdominal     obesity, will be randomized to an intervention group or a control group. The control group     receives general information about physical activity and registration of physical activity     level for one week. The intervention group receives in addition an individualized physical     activity on prescription with patient-centered counseling.      After six months both groups go through the same health check-up as at baseline and     follow-ups take place after 12 and 24 months.   "
73727|NCT02320721|"     Primary Objective:      To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin     A1c (HbA1c).      Secondary Objectives:      To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:        -  Percentage of participants with at least one severe and/or confirmed (by plasma glucose          ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning        -  Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or          confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event        -  Percentage of participants with at least one severe and/or confirmed (by plasma glucose          ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day        -  HbA1c change   "
73728|NCT02320708|"     This is a dental pain study evaluating the efficacy and safety of a single dose of test     acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU)     (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three     or four third molars.   "
73729|NCT02320695|"     The purpose of this study is to have subjects report whether or not several antibiotic     products sting when they are applied to minor wounds created on the inner arms.   "
73730|NCT02320682|"     What is the intensity of F-PET uptake adjacent to four analyzed hip endoprosthetic components     and in healthy femur and acetabulum, 1, 4 and 9 months after surgery?   "
73731|NCT02320669|"     This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine     (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease     during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.   "
73732|NCT02320656|"     HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define     predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and     myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in     vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.      HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic,     pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes     and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or     relapse:        -  tumor samples: marrow aspiration, blood sampling.        -  non-tumor samples: skin biopsy, buccal swab . from 360 patients treated at our cancer          center.   "
73733|NCT02320643|"     The purpose of this study is to evaluate the efficacy, recurrence, postoperative     complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ     prolapse.   "
73734|NCT02320630|"     This trial aims to compare the cost effective and effect of preventing recurrence by     different treatment of TFP and HCQ combined SSZ for remittent RA.   "
73735|NCT02320617|"     The purpose of this study is to investigate the diagnostic accuracy of ADC value of diffusion     weighted MRI in comparison of conventional treatment assessment criteria in evaluation of     chemotherapy. Moreover, the investigators aim to clarify the correlation of ADC value with     histologic type and grade of lung cancer and survival of patients.   "
73736|NCT02320604|"     Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are     not available. Subsequently, the pharmacokinetic profile of AmBisome in this specific patient     population is still largely unknown.      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic     gastric bypass surgery will receive a single dose of 1 mg/kg or 2 mg/kg AmBisome (besides     standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then     be compared to the pharmacokinetics of a normal-weight group.   "
73737|NCT02320591|"     This study assesses the effects of the Centers for Medicare and Medicaid Services'     Comprehensive Primary Care (CPC) initiative on physician practices, practice staff, Medicare     and Medicaid costs and service utilization, quality of care, and patient outcomes. CPC     provides financial resources, timely feedback on key practice outcomes, and a learning     network to support practice transformation to improve quality of care and lower costs.   "
73738|NCT02320578|"     The aim of this prospective randomized pilot study is to verify if the operative time of a     Radical abdominal hysterectomy (LRH) with pelvic lymphadenectomy for early stage cervical     cancer (FIGO stages IA2-IB1-IIA<2cm) and for advanced stage cervical cancer (FIGO stages     IB2-IIA>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response     could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) versus standard     laparoscopy   "
73739|NCT02320565|"     This prospective randomized pilot study is aimed to verify if the operative time of a total     laparoscopical hysterectomy (TLH) with pelvic lymphadenectomy for endometrial cancer FIGO     stage IB-II could be reduced using 3D laparoscopy versus standard laparoscopy   "
73740|NCT02320552|"     The purpose of this study is to determine the prevalence of protein-energy wasting and     obesity among Danish dialysis patients.   "
73741|NCT02320539|"     The purpose of this study is to validate results from a related trial (NCT01791257) and to     compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with     and without systemic complications.   "
73742|NCT02320526|"     Interval training is superior to continuous training for improving glycemic control,     hereunder glycemic variability and -spikes. However, the underlying mechanisms and the     clinical impact is at present unknown.      The overall objective of this project is to determine the mechanisms underlying aeroic     interval-training-induced reductions in glycemic variability and -spikes, and the impact on     levels of systemic inflammation in type 2 diabetes patients. It is hypothesized that aerobic     interval training reduces glycemic variability and -spikes more than continuous training due     to larger improvements in both peripheral insulin sensitivity and the mass action effect of     glucose. Moreover, it is hypothesized that these reductions in glycemic variability and     -spikes also reduces systemic inflammation.   "
73743|NCT02320513|"     This is a pilot study intended to gather data in order to inform future studies about the     role of feedback as an incentive for increasing levels of physical activity which could     improve health in hemodialysis patients.   "
73780|NCT02320032|"     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses     and dosing intervals of aripiprazole lauroxil.   "
79089|NCT02250638|"     To obtain sufficient specimens and correlating clinical data from a well-controlled     prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any     stage of pancreatic cancer.   "
73744|NCT02320500|"     Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as     potential candidates for a knee replacement will receive standard physiotherapy or     myofascial-specific therapy over 8 weeks. Based on the investigators pilot investigation, the     investigators expect those who receive myofascial-specific therapy to experience reduced pain     (compared to the standard therapy group) and increased flexibility compared to baseline     levels. This simple conservative therapy could postpone (or in some cases, eliminate) the     need for a knee replacement since pain is the major indication for surgery. If successful,     this treatment could improve the quality of life and increase productivity for thousands     suffering from knee osteoarthritis and preserve valuable health care resources.   "
73745|NCT02320487|"     This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG     induction therapy in participants with previously untreated CLL. The anticipated time on     study treatment is 24 weeks.   "
73746|NCT02320474|"     This is a one-year pilot, interventional, prospective, single arm, non-randomized,     multicentric (3 centers) controlled study that aims to evaluate the response of type 3     choroidal neovascularization to treatment by Aflibercept following a classic protocol.   "
73747|NCT02320461|"     The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) aims to contribute with     relevant information regarding the development and progression of clinical and subclinical     chronic diseases, particularly cardiovascular diseases and diabetes. The investigators     enrolled 15,105 civil servants from predefined universities or research institutes. Baseline     assessment (2008-2010) included detailed interviews and measurements to assess social and     biological determinants of health, as well as various clinical and subclinical conditions     related to diabetes, cardiovascular diseases and mental health. For the ascertainment of     incident events, annual telephone surveillance is being conducted since 2009, and a second     visit of interviews and exams is under way (2012-2014). Long-term biological sample storage     is provided for sera, plasma, urine and DNA. Baseline data is available for analyses, and     collaboration via specific research proposals directed to study investigators is welcome.      This multicenter study is chaired by a steering committee, made up of the coordinators and     vice-coordinators of each of the six centers. No individual center coordinates the study. The     six institutions listed in the contact details all sponsor the study.   "
73748|NCT02320448|"     This is a feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal     Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal     cancer.   "
73749|NCT02320435|"     This is a single-arm, multi-center, open-label extension study designed to provide pertuzumab     to patients who continue to derive benefit from pertuzumab, as well as to collect long-term     safety and efficacy data of pertuzumab therapy. Patients receiving pertuzumab as an     investigational medicinal product (IMP) in a Roche-sponsored Global study who continue to     receive pertuzumab at the time of the Parent study end are eligible for continued treatment     in this extension study. Patients with solid tumors who have not experienced progressive     disease in the Parent study and, in the Investigator's opinion, may potentially benefit from     continued Perjeta treatment will continue to receive pertuzumab until disease progression,     unacceptable toxicities, Investigator decision, patient non-compliance, patient death,     patient request to withdraw, or study termination by the Sponsor.   "
73750|NCT02320422|"     The purpose of this study is to pilot-test a tailored telemetric intervention to improve     adherence to medications in adults who had a liver transplant and are presently non-adherent     (as measured by tacrolimus levels).   "
73751|NCT02320409|"     The purpose of this study is to evaluate to determine the effect of food on the PK of a     single dose of 250 mg Sufatinib and its metabolites in healthy subjects.   "
73752|NCT02320396|"     This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with     seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change     from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to     placebo.   "
73753|NCT02320383|"     A Prospective, Multicenter, Randomized Phase-Ii Trial Comparing Efficacy And Safety Of     Fludarabine + Cyclophosphamide + Ga101 (Fcg) And Bendamustine + Ga101 (Bg) In Patients With     Relapsed Or Refractory Cll Followed By Maintenance Therapy With Ga101 For Responding Patients   "
73754|NCT02320370|"     The investigators examine the efficacy of two different transcranial direct current     stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label     pilot study in patients who have faced severely stressful life events.   "
73755|NCT02320357|"     CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus     (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement.     As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of     clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.   "
73756|NCT02320344|"     The 3-month face-to-face Partners in Care intervention will be community-based and     community-led by trained community peer educators from these four partnering community     organizations. The intervention involves 12 weekly, group lessons with each lesson lasting     about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels)     greater than or equal to 7% will be recruited for the study because they represent the most     at-risk for diabetes-related complications. Over a 3-year accrual period, the community     partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate     the intervention in their respective community settings. The primary outcomes of our study     are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes     are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood     pressure, body mass index, and psychosocial adaptation.   "
73781|NCT02320019|"     Research Hypothesis:      There will be a greater proportion of VAS responders defined as those who achieve ≥ 50%     reduction from baseline in VAS for low back pain at week 12 following intradiscal injection     of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar     degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered     from persistent low back pain with at least 3 months of conservative therapy and must have     low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the     baseline.   "
73757|NCT02320331|"     The purpose of the OHA PILI 'Ohana Project is to disseminate and evaluate the effectiveness     of a community-based intervention (PILI 'Ohana Intervention Program) aimed at eliminating     obesity in Pacific Peoples across the four islands. Dissemination will involve implementation     of the program in eight communities through partnerships with nine different community-based     organizations serving those areas (four founding community partners and five new community     partners). These organizations provide services to a large number of Pacific Peoples,     including (but not limited to) Native Hawaiians, Samoans, Filipinos, and Chuukese.      The main aims are to: (1) train five additional community organizations and their staff to     deliver the PILI 'Ohana Intervention Program, (2) to enroll 150 overweight/obese participants     across 8 different communities and four different islands into the intervention program, and     (3) to evaluate the effectiveness of the program in reducing weight/BMI by at least 3% of the     participant's initial weight.      The PILI 'Ohana Intervention is a 9-month lifestyle intervention focusing on individual     health behaviors in the context of family and community environments and in the     socio-cultural context of Pacific Peoples. In order to increase the likelihood that an     organization will implement the PLP, they will be able to adapt the intervention and     participant assessments. The POP will provide guidance on adaption of the intervention and     assessments at the training (CHS #21680). What is described below is the maximum amount of     contact and assessment procedures that participants will undergo. Therefore, organizations     may change the timing of the 14 lessons and refrain from using all the assessment procedures,     but will still provide the 14 lessons and offer the same incentives to participants for     assessments.   "
73758|NCT02320318|"     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of     this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as     compared to placebo in women with IBS-D over a 12-week treatment period.   "
73759|NCT02320305|"     This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1     (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid     A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that     has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body     build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with     MART-1 antigen may help increase the immune response to MART-1a antigen.   "
73760|NCT02320292|"     This randomized phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to     see how well they work compared to rituximab alone in treating patients with untreated     follicular lymphoma. Monoclonal antibodies, such as rituximab, may find cancer cells and help     kill them. Radioactive substances linked to monoclonal antibodies can bind to cancer cells     and give off radiation which may help kill cancer cells. It is not yet known whether     rituximab works better with or without yttrium Y-90 ibritumomab tiuxetan in treating     follicular lymphoma.   "
73761|NCT02320279|"     The objective is to contribute data to ongoing research activities focused on identification     of EKG waveform changes in the context of clinical conditions and maternal medication use.     Additionally, to develop the capacity to measure contractions more accurately and more     reliably using skin-surface electrodes.   "
73762|NCT02320266|"     Deep brain stimulation (DBS) is an FDA approved, and widely used method for treating the     motor symptoms of Parkinson's disease (PD), Essential Tremor (ET), Dystonia and Obsessive     Compulsive disorder (OCD). Over 100,000 patients worldwide have now been implanted with DBS     devices. Current approved methods to locate the DBS target regions in the brain use a     combination of stereotactic imaging techniques and measurements of the electrical activity of     brain cells. As part of the standard clinical technique, electrical data are collected from     individual nerve cells. The target brain region emits unique electrical signals. At certain     brain locations, during DBS surgery, additional electrical data that are generated in     response to sound will be collected. Regions of the brain that have a decreased response to     repeated sound (auditory gating) may be important DBS targets for improving thinking. The     aims are (i) during DBS surgery, in addition to EEG, use microelectrodes in the brain to find     brain regions, along the normal path to the DBS target, where auditory gating occurs and then     (ii) determine if stimulation of the identified region(s) alters auditory gating measured by     EEG. Also an additional aim (iii) is to measure electrical activity at the scalp with EEG to     characterize auditory gating in patients before and after DBS surgery and also a healthy     control population.   "
73763|NCT02320253|"     The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for     type 2 diabetes and obesity into usual care at community health centers, comparing an     in-person group program (IP), a telephone conference call (TCC) group program, and referral     to medical nutrition therapy (MNT), the current standard of care.   "
73764|NCT02320240|"     The purpose of this study is to determine if there is an excess risk of acute kidney injury     (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective     serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of     depression.   "
73765|NCT02320227|"     To evaluate the safety of a personal lubricant when used as indicated as a personal lubricant     in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a     population of healthy females   "
73766|NCT02320214|"     To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a     personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two     weeks in a population of healthy females.   "
73767|NCT02320201|"     To determine the effects of electrical stimulation of the nerves in the foot on overactive     bladder conditions in children.   "
73768|NCT02320188|"     The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy     of eccentric exercise training in restoring muscle mass and function in patients with     rheumatoid cachexia.   "
73843|NCT02319200|"     Metformin treatment during 36 months could be associated with decreased risk of HCC     occurrence and liver related death in patients with compensated HCV cirrhosis and     insulinoresistance.      This study is an ancillary of the observational study from the CIRVIR cohort in which more     than 1200 patients with compensated HCV cirrhosis are currently included.      participating centers : 26   "
73769|NCT02320175|"     The investigators propose implementing a bundle of communication interventions - Patient and     Family-Centered I-PASS - to improve the quality of information exchange between physicians,     nurses, and families, and to better integrate families into all aspects of daily decision     making in hospitals. The investigators believe that doing so has the potential to     substantially improve both patient safety and patient and family experience.      The specific aims of the project are - To test the hypothesis that a) rates of serious     medical errors (including both preventable adverse events and near misses), determined both     by an established, systematic daily hospital surveillance methodology (primary outcome) and     family reports (secondary outcome); as well as b) poor verbal handoffs during family centered     rounds (FCRs - assessed through direct observation - secondary outcome); rates of discordant     understanding of the care plan between healthcare providers and families (assessed through     survey instruments - secondary outcome); and rates of family (primary outcome) and nurse and     physician dissatisfaction (secondary outcomes) will decrease following implementation of     Family-Centered I-PASS, as compared with current practice.   "
73770|NCT02320162|"     The aim of this project was to compare the effectiveness of experiential learning (EL) and     traditional lecturing (TL) school-based oral health education on the oral health knowledge,     attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old     Greek children. Thee hundred and fifty children were selected from three areas of Greece.     Information on oral health knowledge, attitude and behaviour were obtained using a     questionnaire. Dental plaque was recorded using a modified hygiene index, gingivitis was     assessed using the simplified gingival index and dental caries was measured by recording the     number of Decayed, Missing and Filled teeth (DMFT) using the British Association for the     Study of Community Dentistry (BASCD) criteria. All children were examined by two calibrated     dentists, using a World Health Organisation (WHO) periodontal probe and artificial light.     Questionnaires were delivered and clinical examinations were performed at baseline and at 6     and 18 months post-intervention. The EL oral health educational program was implemented by     teachers using the program's manual.   "
73771|NCT02320149|"     To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline     compared to placebo in the treatment of moderate to severe facial acne vulgaris   "
73772|NCT02320136|"     The investigators want to characterize high-frequency oscillations (HFOs) in intracranial     recordings, which may occur as markers of epileptogenic tissue and also under physiological     stimulation.      The investigators want to show that recording of high-frequency oscillations (HFOs) is     feasible in our project population both intraoperatively and during presurgical physiological     conditions.   "
73773|NCT02320123|"     Racial differences in health care are documented across the health care continuum and persist     in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented     minorities often choose more aggressive therapies at the end of life and are less likely to     utilize hospice care in the terminal stages of their illness. Potential reasons for these     disparities include: lack of knowledge of and misperceptions about palliative and hospice     care, spiritual beliefs, and mistrust in the health care system, among others. Despite the     literature on disparities in end-of-life (EOL) care and reasons for underuse and the presence     of national EOL care guidelines, attempts to address this problem have been limited and often     not rigorously evaluated. The majority of interventions to promote EOL care were done in     majority populations and focused predominantly on trying to change physician awareness of     patient's pain, symptoms, and values or to change physician communication behavior. While     these early studies made tremendous contributions to the study of EOL care and the needs of     the terminally ill, the interventions associated with these studies did not reach their     desired effectiveness. The investigators propose a different strategy that would focus     specifically on previously identified barriers to utilization of advance directives,     palliative care, and hospice care among African Americans - including physicians' difficulty     and discomfort with prognostication, AA patients' knowledge, attitudes and beliefs towards     hospice and palliative care, conflict between patients' spiritual beliefs and the general     hospice and palliative medicine philosophy of care, and medical mistrust. The goal of this     project is to improve methods of prognostication for physicians and increase awareness of EOL     care options for AAs. To overcome the dual challenges of physicians' reluctance to discuss     EOL care and patients' discomfort in engaging in such conversations, the investigators will     use the electronic medical record (EMR) to automatically identify AA patients with     life-limiting illness who are eligible for counseling about EOL care options. To change     knowledge and attitudes toward EOL care options among AA patients, the investigators will     design a culturally sensitive intervention that will combine multimedia materials and a     culturally concordant lay health advisor who will deliver tailored education and counseling.   "
73774|NCT02320110|"     Childhood obesity is one of the most serious global public health challenges of the 21st     century (Daniels et al., 2009). Mexico has the highest prevalence of obesity, (Secretaría de     Salud, 2009); 34.4% of children and 35% of adolescents are overweight or obese (ENSANUT     2012). Obesity has major health consequences for children and adolescents; On the other hand,     undernutrition as well has important deleterious consequences on children's health.      Anything that disrupts energy balance may cause individuals to be underweight, overweight or     obese. Fat has been considered an endocrine organ for some time (Elizondo, 2011). Recently,     skeletal muscle has been shown to function as a peripheral endocrine organ by releasing     myokines, (Pedersen, 2012). Most recently, a new identified hormone secreted by muscle tissue     in mouse, irisin, has been discovered. Irisin acts on white adipose cells in culture and in     vivo to stimulate UCP1 expression and a broad program of brown-fat-like development. Irisin     was induced with exercise in mice and humans which caused an increase in energy expenditure     in mice with no changes in movement or food intake (Boström et al., 2012).      Irisin was thus, promptly hypothesized as a hormone influencing body weight, obesity and type     2 diabetes mellitus, among other conditions (Sanchis-Gomar et al., 2012). Some studies have     indicated that circulating levels of irisin in humans correlate positively with     anthropometric parameters such as BMI, fat mass, fat free mass, and are higher in obese     patients compared to lean ones (Stengel et al., 2013; Huh et al., 2012; Roca-Rivada et al.,     2013; Crujeiras et al., 2014; Pardo, 2014). Studies have shown an association between irisin     levels, insulin resistance and the metabolic syndrome (Park et al., 2013; de la Iglesia et     al., 2014; Crujeiras et al., 2014; Pardo et al., 2014). However, some others have found a     negative correlation with anthropometric parameters, finding lower irisin levels in obese     patients (Moreno-Navarrete et al., 2013). Noteworthy, all these studies have been performed     in adults. To date, there are only two studies evaluating irisin levels in children. One     found that a 1-year long lifestyle intervention program was associated with an elevation in     irisin levels in obese children, although no correlation was found between irisin levels and     anthropometric markers (Blüher et al., 2014). The other study investigated normal weight     Saudi children and found correlations between circulating irisin and glucose and HDLc, but a     negative association with insulin resistance (Al-Daghri et al, 2014).      Besides, associations between irisin levels and adiponectin, leptin and resistin in the set     of obesity have been explored, the three of them are implicated in the physiopatology of     obesity.      As there are still conflicting data regarding the association of irisin with anthropometric     parameters, obesity and the metabolic syndrome, as well as its 'association with other     adiponectines, and most important, there is scarce data of these associations in children,     the objective of this study will be to correlate the circulating irisin and adipokines levels     across a broad spectrum of body mass index ranging from undernourished to obese as well as     with insulin resistance and risk factors for the metabolic syndrome in Hispanic children.      The sample size with statistical power for this study yielded a sample of 40 children. Frozen     stored plasma (-80°C) will be taken from a previous study performed in children which has     been published (Elizondo-Montemayor et al., 2014). The samples will be divided into five     groups, 8 per group, according to the CDC and American Academy of Pediatrics body mass index     percentile classification: 1.) underweight = <3 percentile; 2.) normal weight = >3 - < 85     percentile; 3.) Overweight = >85 - < 95 percentile, and 4.) obese = > 95 percentile. The     fifth group will correspond to children with known metabolic syndrome according to the     classification specified by Cooks et al (2008). Anthropometric measurements will include BMI,     percentile BMI, waist circumference, % body fat, fat mass, fat free mass, and triceps skin     fold. Biochemical measurements will include glucose, total cholesterol, low-density     cholesterol (LDL), high-density cholesterol (HDL-c) and triglycerides. Clinical measurements     will include blood pressure, physical activity records and dietary habits. All biochemical,     anthropometric and clinical measurements were previously performed in a former published     study (Elizondo-Montemayor et al., 2014).      Irisin, adiponectin and leptin will be measured in plasma media using commercial ELISA kits.   "
73775|NCT02320097|"     When examining a subject in quiet stance from the side, the leg segment is usually seen to be     oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the     shoulders are behind the great trochanter and the head is held forwards. The forward head     position moves the center of gravity forwards and thus may increase pressure under the     forefoot. Conversely, moving the head backwards should be accompanied by an increase in     pressure under the heel and thus decreased pressure under the forefoot.      The study's objective is to study the influence of alignment of the head with the back (i.e.     a rearward head position) and head rotation on the foot pressure distribution (measured using     a foot pressure platform).   "
73776|NCT02320084|"     The purpose of this study is to look at the long term safety profile of Orfadin treatment in     patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study     will use Orfadin according to normal clinical practice.   "
73777|NCT02320071|"     The primary objective of the present study is to investigate a possible correlation between     abdominal wall function and subjective measures of QoL before and after laparoscopic repair     of small- to medium sized incisional hernia.      This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair.     Abdominal wall function is examined by determination of maximal truncal flexion and extension     with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland).     Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity     (International Physical Activity Questionnaire) are assessed. Patients are examined before,     one month after and three months after the operation. Furthermore, pulmonary function is     examined preoperative and three months postoperative by standard spirometry (forved vital     capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in-     and expiratory pressure is measured.   "
73778|NCT02320058|"     This is a study of Nivolumab combined with Ipilimumab followed by Nivolumab by itself for the     treatment of patients with Melanoma that has spread to the brain. Patients with     histologically confirmed Malignant Melanoma and asymptomatic brain metastases are eligible     for the study.   "
73779|NCT02320045|"     A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and     moderate renal impairment compared to the pharmacokinetics of subjects with normal renal     function   "
73782|NCT02320006|"     Acupuncture is one of the traditional Chinese practices widely used in China for more than     3000 years. In recent years, the use of acupuncture within infertility has gained popularity     all over the world, but there is no research describing the use of acupuncture in infertility     of incompletely obstructive fallopian tube. In this paper, we present a research design     evaluating the effects of acupuncture on incomplete fallopian tube obstructive infertility.     This is a randomized, control acupuncture and signal-blind trial. A total of 120 patients     will be enrolled in this study and will be randomized into two groups. True acupuncture plus     hydrotubation or control acupuncture plus hydrotubation will be performed for 12 weeks. The     purpose of this paper is to evaluate the additional value of acupuncture on the tubal patency     rate and pregnancy rate beyond Hydrotubation ,therefore to guide clinical.   "
73783|NCT02319993|"     keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life,     Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan   "
73784|NCT02319980|"     The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass     surgery could prevent rebleeding and improve neurological function in adult moyamoya with     hemorrhagic onset.   "
73785|NCT02319967|"     Chicago is an epicenter for asthma health disparities in the U.S., with African-American     children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of     these disparities is the high rate of visits to the Emergency Department (ED) for     uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of     guideline recommendations for ED discharge and strategies to reduce environmental triggers at     home contribute to practice variation and poor adherence to guidelines. The CHICAGO Trial     tests both ED- and home-level interventions to improve clinically meaningful outcomes in a     minority pediatric ED population with uncontrolled asthma.   "
73786|NCT02319954|"     Periorbital edema and ecchymosis are common morbidities in the post-operative period after     rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large     contributing factors to the degree of bruising and edema. This is due to injury to the     angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling     and bruising, it can cause difficulty with visual acuity in the early post-operative period.     Most importantly, this can be quite distressing to the patient and impact the time required     to return to normal social activities. Numerous studies have examined various interventions     to reduce periorbital swelling and ecchymosis. These include peri-operative steroids,     lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension     and subperiosteal osteotomy techniques. Peri-operative steroids have been most extensively     studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids were     effective for decreasing post-operative edema and ecchymosis. Steroids however, carry with it     the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and     avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques to     minimize post-operative edema and ecchymosis without the risk profile of steroids would be     ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative cold     saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study group     received compression with a cold saline soaked gauze to the nasal dorsum during the surgery     and the control group received compression with a dry gauze. Both groups received a     pre-operative dose of intravenous steroids. The study group had significantly less     periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study     unfortunately did not examine the role of compression alone and the study was performed in     the presence of steroids, which is not routinely utilized by all surgeons. As such, the     proposed study will provide evidence for the use of direct compression intra-operatively     after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings     of this study may provide a simple, effective and non-costly technique to minimize the     morbidity of rhinoplasty.   "
73787|NCT02319941|"     The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel     for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes   "
73788|NCT02319928|"     This protocol describes the epos (ancient greek (Επος) for story) of a group of related     clinical trials aiming at addressing one of the most important unsolved challenges in the     prevention of colorectal cancer (one of our major cancer killers); the surveillance of     patients with premalignant polyps in the large bowel.      This project is timely because large scale colorectal cancer screening programmes are     currently rolled out in most Western countries. These programmes are diagnosing large numbers     of individuals with premalignant polyps (adenomas and serrated polyps). This creates both a     diagnostic and resource dilemma, because the optimal surveillance strategy for these     individuals to reduce future cancer risk is currently unknown..      The EPoS trials will randomize or register more than 27,500 individuals in different European     countries to different surveillance colonoscopy intervals to disentangle the most effective     and cost-effective surveillance strategy for the population. Subjects will be randomized     according to their presenting polyp chracteristics The EPoS I trial randomizes patients with     low-risk adenomas into 5 or 10-year surveillance; ; EPoS II randomizes patients with     high-risk adenomas into 3 or 5-yearly surveillance ; EPoS III will include patients with     serrated polyps in a one-arm study with surveillance after 5 and 10 years. The primary     endpoint for all three trials is incidence of colorectal cancer after 10 years of follow-up.      This EPoS trials are the largest in polyp surveillance ever conducted. They address a     clinical problem affecting hundreds of thousand individuals in Europe and the US each year,     it has a large size, and should thus provide definitive results.   "
73789|NCT02319915|"     Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or     without adrenaline, in a population of patients undergoing knee replacement.   "
73790|NCT02319902|"     To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea     and analgesic requirements in post operative patients compared to standard cold carbon     dioxide.   "
73791|NCT02319889|"     This pilot clinical trial studies stereotactic body radiation therapy followed by combination     chemotherapy in treating patients with non-small cell lung cancer. Stereotactic body     radiation therapy is a specialized radiation therapy that delivers one to five high doses of     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal     tissue than conventional radiation. Drugs used in chemotherapy, such as carboplatin and     paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving stereotactic body radiation therapy, followed by     carboplatin, and paclitaxel albumin-stabilized nanoparticle formulation may kill more tumor     cells and result in a better and more durable response than conventional radiation and     chemotherapy. The purpose of this study is to test the safety of this approach prior to     larger studies.   "
73792|NCT02319876|"     The current project was designed to examine the express TIM-3 on lymphocytes and monocytes     and its role in immunosuppression during sepsis.   "
73793|NCT02319863|"     This study examines the role of this simple technique on postoperative metastasis and long     term survival.   "
73794|NCT02319850|"     Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over     the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability.     Despite these observations, sarcopenia is rarely subject to a systematic screening process as     a part of customary geriatric care. Furthermore, when lean body mass (LBM) is measured via     dual energy X-ray absorptiometry (DXA) in older adults, it is typically within a reactive,     hospital-based, model of healthcare where muscle wasting is only assessed after a loss of     functional independence. The investigators propose an affordable, portable screening method     with ultrasound imaging to be performed in primary care settings.      The investigators long term goal is to identify individuals at risk, and intervene with     treatments that may prevent the onset of debilitating loss of muscle function in the elderly.   "
73795|NCT02319837|"     The purpose of this study is to assess enzalutamide plus leuprolide in patients with     high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or     radiotherapy or both.   "
73796|NCT02319824|"     This pilot, phase I trial studies the safety of cancer-testis antigen (NY-ESO-1)-specific T     cells (a type of immune cell) in treating patients with NY-ESO-1-expressing sarcomas that     have spread to other places in the body and are receiving palliative (relief of symptoms and     suffering caused by cancer) radiation therapy. Placing a modified gene for NY-ESO-1 into     white blood cells may help the body build an immune response to kill tumor cells that express     NY-ESO-1. Palliative radiation therapy may help patients with advanced sarcoma live more     comfortably. Giving NY-ESO-1-specific T cells following palliative radiation therapy may be a     better treatment for patients with sarcomas.   "
73797|NCT02319811|"     The purpose of this study is to determine the long-term survivorship and clinical outcomes of     all cryopreserved meniscus transplants performed by Dr. Frank Noyes.   "
73798|NCT02319798|"     Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and     ulcerative colitis) that affect the intestines. The number of new cases of IBD in people     younger than 16 years old has been increasing in the United Kingdom (UK), and is currently     estimated to be 700 new cases every year. There is no cure for IBD and patients experience     episodes of flareups in between periods of wellbeing.      Traditionally, children with IBD are asked to attend regular hospital appointments. This     means that, even if they are well, they have to get to the hospital and this can involve     travelling long distances.      Telephone consultations have been shown to be beneficial in some areas of medicine but this     approach has not been well studied in children. The aims of this study are to determine     whether telephone consultations would improve quality of life, patient satisfaction,     proportion of consultations attended and whether they would be safe and reduce costs for     patients and the National Health Service (NHS). Investigators plan a randomised controlled     trial involving 92 participants recruited from amongst the 250 children and adolescents aged     between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will     be assigned to telephone consultations, and half to face to face consultations. The study     would have the approval of the local ethics committee and participants would have provided     written consent. Investigators will compare outcomes in the two groups over 2 years. If     telephone consultations prove to be effective, the NHS could offer children with IBD the     choice of either telephone consultation or face to face consultation for their outpatient     followup. Those who are doing well would not have to make unnecessary journeys to the     hospital. This would free up clinic spaces and allow patients who are unwell, and new     patients to be seen more quickly, thus reducing waiting   "
73799|NCT02319785|"     The main purpose of this study is to examine the treatment effects and the combined-therapy     of the robot-assisted therapy (RAT) by using two groups of combined-therapy with different     sensory feedback and one group of unilateral RAT in the investigators trial to compare the     relative treatment effects to mirror therapy group, bilateral RAT, and conventional     rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of     life, and kinematic variables.   "
73800|NCT02319772|"     This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and     pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection     in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2     subjects will receive BCX4430 for 7 days.   "
73801|NCT02319759|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab     in participants with Active Psoriatic Arthritis (PsA).   "
73802|NCT02319746|"     General objective:      To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive     behavioral treatment + pharmacological treatment) compared to standard treatment     (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP)     cannabis users.      Design A multicenter single-blind randomized study with 1 year of follow-up. The     effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral     treatment + pharmacological treatment) compared to standard treatment (pharmacological     treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users     will be assessed.      Patients will be randomly assigned to one of two treatments:        1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse +          pharmacological treatment        2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment   "
73803|NCT02319733|"     The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS)     for intermediate coronary lesions with morphological signs of vulnerable plaque in patients     prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural     vasomotion and increase vascular diameter.   "
73804|NCT02319720|"     Management of chronic wounds with:        1. Bone Marrow Aspirate Plus Cultured Cells Group        2. Cultured Cells Alone Group        3. Bone Marrow Aspirate Alone Group        4. Control Group   "
73805|NCT02319707|"     To compare the efficacy of three different protocols of third stage management in preventing     PPH.   "
73806|NCT02319694|"     This project studies the impulsive side effects of common treatments for Parkinson's Disease.     By learning how parts of the brain involved in Parkinson's encode information related to     reward and motivation, the investigators will better understand the reasons why Parkinson's     patients often suffer from compulsive gambling, hypersexuality, and repetitive tinkering     (punding). These results may lead to the design of better methods of deep brain stimulation     (DBS) that minimize the behavioral side effects of Parkinson's treatment.   "
73844|NCT02319187|"     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.      The purpose of this study is to evaluate the progression free survival and safety of     irinotecan plus S1 versus S1 alone in the patients with previously treated advanced     esophageal cancer   "
77134|NCT02276222|"     This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week,     open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a     day or Spiriva® [tiotropium] given as 18 mcg once a day).   "
73807|NCT02319681|"     This study seeks to establish the acceptability and evaluate the limited efficacy of Simple     Reminiscence (SR), a home-delivered non-pharmacological intervention designed to relieve     stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in     community-residing individuals diagnosed with early Alzheimer's disease (EAD). Unmanaged     episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger,     and sometimes even violence.      SR is a dyadic strategy; both the person with EAD and the caregiver engaged the patient's     memory to interrupt a current episode of anxiety.   "
73808|NCT02319668|"     The primary objective of this study will be to evaluate the effect of two week pre-surgical     rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the     total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be     conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL)     Eastman Dental Institute. Participants will be those who require a single and simple surgical     implant to be placed, and will be recruited from new patient referrals within the Eastman     Dental Hospital   "
73809|NCT02319655|"     During the last decade optical coherence tomography (OCT) extended the possibilities for in     vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of     retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased     scanning speed and image-resolution provides more detailed information of microstructures in     the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the     eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as     uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from     loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to     remove the ERM.      Different study groups showed that intraoperative use of SD-OCT is possible. Two groups     already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial     resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the     subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized     that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone     disappears in follow up OCT 10 days after surgery.   "
73810|NCT02319642|"     This study will continue to evaluate the safety & efficacy of Certolizumab Pegol (CZP) for 6     months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.   "
73811|NCT02319629|"     Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the     gallbladder function which is secondary to surgery. Many observational studies support this     fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in     them. According to another publication, the incidence of gallbladder diseases is 5-36% after     jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.   "
73812|NCT02319616|"     The primary objectives of this study are to investigate the efficacy and safety of topical     steroid ointment (clobetasol 0.05%) for the treatment of the cutaneous manifestations of     toxic epidermal necrolysis (TEN).   "
73813|NCT02319603|"     A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing     clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial     premature beats by different dose,to provide a scientific basis for rational clinical use of     drug.   "
73814|NCT02319590|"     The study aims 1) to determine autoantibody titers against the AGTR1 receptor and against the     ETA receptor, 2) to characterize cytokine expression profiles of heart-specific activated T     cells in patients with systolic heart failure. Auto-antibody titers and specific cytokine     expression profiles in heart-specific activated T cells will then be correlated with heart     failure progression and outcome.   "
73815|NCT02319577|"     A sub-population of patients affected by non-small cell lung cancer (NSCLC) with activating     mutations of the epidermal growth factor receptor (EGFR) do not gain benefit from treatment     with tyrosine-kinase inhibitors (TKIs). The hypothesis of this study is that the addition of     chemotherapy with oral vinorelbine to first-line TKI might result in improved outcomes in     EGFR-mutated patients.   "
73816|NCT02319564|"     The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose     is to determine the feasibility of a randomized trial designed to determine if either inhaled     beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are     superior to placebo in treating pre-school aged children with an acute wheezing episode.   "
73817|NCT02319538|"     The investigators have already proven that absolute total thyroidectomy gives elimination of     anti-TPO antibodies. Our hypothesis is that this elimination also eliminates the typical     Hashimoto symptoms, namely: Serious tiredness, increased need of sleep, pain in musculature     and joints and dryness in eyes and mouth. The prerequisite for this effect is the absolute     total thyroidectomy. There exists no other treatment that can eliminate the antibodies. The     study is randomized between operation and ordinary conservative medical treatment with     thyroxine control and supplementation. The symptoms in both groups are evaluated by 5     different Quality of Life schemes, internationally approved.   "
73818|NCT02319525|"     The study will compare the efficacy of the usual education materials to individualized     computerized decision guide on decision conflict of patients with lupus nephritis making     treatment decisions regarding immunosuppressive therapies.   "
73819|NCT02319512|"     The purpose of this study is to determine whether the use of chewing gum effects     postoperative ileus after pancreaticoduodenectomy.   "
73860|NCT02318979|"     The proposed study aims to characterize the effects of running-specific leg prosthetic     stiffness and height during on performance during running and sprinting to optimize     running-specific prosthesis prescription. The investigators will collect biomechanical and     metabolic data from participants with unilateral and bilateral below the knee amputations     while they run at different speeds on a treadmill. This data will be used to understand the     effects of running prostheses. Then, these parameters will be used to develop prosthetic     prescription techniques for people with below the knee amputations.   "
73861|NCT02318966|"     To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management     of hepatic glycogen storage diseases (GSD).   "
77135|NCT02276209|"     This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating     the efficacy and safety of dasotraline in adults with ADHD.   "
73820|NCT02319499|"     Many Indonesian infants are already iron deficient before they reach the age of six months,     which also determines the high prevalence of anemia among under-five children. Iron     deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency     anemia during early childhood has a marked negative effect on child development and cognitive     function (Lozoff et al.1991; Idjradinata & Pollitt, 1993). This negative impact on childhood     development is one of the main reasons why iron deficiency during infancy should be prevented     or treated.      Since diets low in iron is usually also low in zinc, zinc deficiency --which has negative     consequence on growth-- is common in iron deficiency area. In Southeast Asia, the condition     is exacerbated by the rich phytate content in the complementary foods which inhibits the     absorption of iron as well as zinc (Gibson, 1994). Thus, combining both iron and zinc, hence,     is expected to decrease both iron and zinc deficiencies and hence improve growth and     development of the children.      Recently, there has been an emerging view which looks at the two-way relationship between     nutrition, health, and psychosocial well-being. This concept is supported by studies on     positive deviance, a term used to refer to children who grow and develop well in     impoverished environments where most children are victims of malnutrition and chronic illness     (Zeitlin et al., 1990). The mechanism which helps to explain how psychosocial factors, such     as the affect between mother and child, are associated with adequate growth and development:     'Psychological stress has a negative effect on the use of nutrients whereas psychological     well-being stimulates the secretion of growth-promoting hormones. Pleasantly stimulating     interactions can enhance the child's tendency to exercise its developing organ systems and     hence to utilize nutrients for growth and development'.      Understanding how the psychosocial environment can promote or inhibit the benefit of     supplementation intervention is necessary in order to have a better way of setting about     providing supplements. In fact, many supplementation programs do not incorporate     complementary program elements that would help to improve the health and psychosocial     development of children at the same time that they improve nutritional status' (Myers, 1995).     Looking from this perspective, not only will supplementation benefit the psychosocial     development but also the psychosocial environment can promote the benefit of the     supplementation on the nutritional status and developmental outcomes of infants.      The purpose of the study is to investigate whether multi-micronutrient supplementations     (zinc+iron, zinc+iron+vit.A) have positive effect on infants' growth and developmental     outcomes, and whether the effect is modified by psychosocial care.   "
73821|NCT02319486|"     This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular     retinoblastoma   "
73822|NCT02319473|"     Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to     the emergency department of all health centers in Jakarta and the surrounding area.   "
73823|NCT02319460|"     This observational cohort study is designed to obtain product safety information from the     routine clinical setting within large, diverse, community-based populations. In the setting     of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the     risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated     with plasma will be assessed.   "
73824|NCT02319447|"     For most patients with kidney failure, living donor kidney transplant (LDKT) is their best     treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney     failure but less likely to receive LDKTs. In this study, the investigators will test an     intervention designed to address this disparity, by performing a parallel group, two-arm     randomized clinical trial among 500 Black kidney transplant candidates. The main objective of     this study is to test an educational and behavioral intervention that is designed to increase     receipt of LDKT among transplant candidates (persons active on the deceased donor kidney     transplant waiting list) who are Black. Our overall hypothesis is that a multi-component     intervention administered to Black transplant candidates will increase both readiness to     pursue LDKT and actual receipt of LDKTs. The investigators will randomly assign kidney     transplant candidates on the kidney transplant waiting list to either: (1) a control group     that will receive Usual Care, or (2) an Intervention group that will receive a group-based     intervention, as well as monthly mailings and a follow-up phone call by a transplant     educator.   "
73826|NCT02319421|"     Context: Alarm fatigue is a threat to hospital patient safety. National surveys reveal that     high alarm rates interrupt patient care, reduce trust in alarms, and lead clinicians to     disable alarms entirely. Safety huddles offer an appropriate forum for reviewing alarm data     and identifying patients whose high alarm rates may necessitate safe tailoring of alarm     limits.      Objectives: To evaluate the impact of a focused physiologic monitor alarm reduction     intervention integrated into safety huddles that involves discussing safe monitor parameter     adjustments on the physiologic monitor alarm rates of individual patients with high alarm     rates who meet low acuity criteria.      Study Design: A prospective, quasi-experimental pilot study of the impact of the huddle     intervention on the alarm rates of low acuity high alarm rate individual patients discussed     in huddles in the PICU. The huddle intervention will consist of a script to facilitate the     discussion of the alarm data.      Setting/Participants: Participants will include all low acuity patients and their providers     in the PICU at The Children's Hospital of Philadelphia.      Study Interventions and Measures: The primary outcome is the rate of crisis and warning     alarms per patient day for intervention cases as compared with others in the high alarm / low     acuity cohort. Safety measures will include unexpected changes in patient acuity or code blue     events within one week of monitor change or discharge.   "
73827|NCT02319408|"     Insufficient migration and activation of tumour specific effector T cells seems to be the one     important reason for inadequate host anti-tumour immune response. Ionizing radiation can     induce a variety of immune responses. The goal of this randomized trial is to assess if a     preoperative single fraction low dose radiation is able to improve anti-tumour immune     response in operable early stage lung cancer.   "
73828|NCT02319395|"     The  Behavioural Addiction and Genetics in Parkinson's Disease  study (BADGE-PD) is a     national (France), multicenter, genetic association, case-control study to identify genetic     factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to     dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes     supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD     (n=200) and 200 matched PD patients without ICD (n=200).   "
73862|NCT02318953|"     This study evaluate if in an ambulatory breast reconstruction patient population at Women's     College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app     home monitoring compared to conventional, in-person follow-up care in the first 30-days     following surgery.   "
73863|NCT02318940|"     The purpose of this study is to compare the effectiveness and safety of the installation of     femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark     method   "
79846|NCT02240797|"     The purpose of this study is to use positron emission tomography (PET) imaging and magnetic     resonance imaging (MRI) to understand the brain function of individuals with anorexia nervosa     and healthy controls.   "
73909|NCT02318342|"     This is a prospective study designed to evaluate the structural and functional integrity of     transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further     aims to confirm resolution of the early bioprosthetic valve thrombotic changes with Vitamin K     antagonists (warfarin) mediated anticoagulation therapy.   "
73829|NCT02319382|"     There is accumulating evidence suggesting that inflammatory processes, through microglial     activation, would play a key role in the neurodegenerative process of Parkinson's disease     (PD). It is considered that microglial activation would be part of self-propelling cycle of     neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however     hard to evidence microglial activation in vivo, especially in the substantia nigra: first,     the investigators need very high resolution imaging tools and then, the only ligand available     to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous     results.      18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to     explore the topography and intensity of microglial activation in several different groups of     PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients     (honeymoon) (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off     or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to     healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a     new generation tomography having a very high resolution.      This study might reveal significant neuroinflammatory process in the midbrain of PD patients     and will determine if such process is present in both sporadic and genetic forms of PD. The     results of this study might provide a new biomarker of disease pathological progression and     help as identifying subjects who might most benefit from a specific anti-inflammatory drug.   "
73830|NCT02319369|"     This will be a Phase 1, open-label study of DS-3032b to assess its safety and tolerability     and identify a Maximum Tolerated Dose (MTD)/tentative Recommended Phase II Dose (RP2D) in     subjects with refractory or relapsed Acute Myelogenous Leukemia (AML), Acute Lymphocytic     Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in blast phase, or high risk MDS in Part     1-Dose Escalation and refractory or relapsed AML or high risk Myelodysplastic Syndrome (MDS)     in Part 2-Dose Expansion.   "
73831|NCT02319356|"     The purpose of this study is to determine whether dietary nitrate supplementation improves     performance in cardiopulmonary exercise testing (CPET).   "
73832|NCT02319343|"     This study evaluates the pathophysiological effects of a single dose Methylprednisolone     administered prior to total knee-arthroplasty (TKA). The investigators examine the effect on     thigh muscle function to evaluate the efficacy of Methylprednisolone on knee-extension     strength at discharge after TKA.      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will     receive placebo.      The investigators hypothesize that the group receiving Methylprednisolone will experience     smaller loss of knee-extension strength compared to the placebo-group, early after TKA.   "
73833|NCT02319330|"     The overall objective of this project is to demonstrate that a low cost, cell phone-delivered     intervention is a promising, feasible and acceptable way to improve the prevention and     treatment outcomes of women in India who are affected by HIV and inter-related mental health     and psychosocial risk factors.   "
73835|NCT02319304|"     The purpose of this study is to assess the effects, both good and bad, of adding very low     dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to     surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over     approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each     cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the     first two days of each cycle.   "
73836|NCT02319291|"     This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150     RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and     the follow up period will be 5 years. Data collection will include Radiographic Analysis,     Knee Society Evaluation and Adverse Events.   "
73837|NCT02319278|"     To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of     iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the myocardium     of patients with:      i. cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis   "
73838|NCT02319265|"     DAMSEL 2 is a pilot Phase II study in patients with sepsis. Stage 1 will assess the     pharmacokinetics of melatonin and its major metabolite after a single dose of 50 or 100mg     exogenous melatonin in two small groups of patients with sepsis in order to make dosing and     dosing interval decisions for Stage 2.      Stage 2 is a double blind randomised controlled trial of melatonin in patients with sepsis at     the dose and dosing interval decided after Stage 1. Measurements of melatonin and its major     metabolite, and an array of biomarkers of inflammation and oxidative stress will be made,     plus transcriptome (mRNA) analysis. This study will inform a planned larger phase II trial.   "
73839|NCT02319252|"     The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal     feeding tubes are the most effect full to feed patients with alcoholic liver diseases and     non-sufficient oral intake.      The primary outcome will be differences in nutrition intake between the groups. Secondary     outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients'     quality of life, nausea & vomiting.      The study will include 40 patients at Aarhus University Hospital, Denmark.   "
73840|NCT02319239|"     Primary purpose of the study is to develop a stereotactic radiation treatment to prostate     cancer which minimizes treatment related toxicity. Movement of the prostate during a     radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This     data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation     toxicity to rectum will be reduced by using a rectum fixation during a treatment.      Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with     20 x 3 Gy fractionation schedules. With the data collected from these groups treatment     marginals to prostate will be defined and used to treat group III (40 patients) with 5 x 7.25     Gy.      Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging     could be used to evaluate radiation treatment response in intermediate prostate cancer.     Androgen deprivation therapy is not allowed in this study.   "
73841|NCT02319226|"     Graft-versus-Host Disease (GVHD), is the most frequent and severe complication of allogeneic     hematopoietic stem cell transplantation (HSCT). Much of our knowledge on the pathophysiology     of GVHD has been gained from experimental models but far less from the study of the disease     in humans. Recent developments in basic biology open new avenues to the development of     biomarker sets that could predict GVHD severity and prognosis that could be tested and     validated through well-designed multicenter clinical trials.      The main goal of this project is to further our understanding of the pathogenic mechanisms of     human GVHD on one hand, and of functional immune tolerance on the other. Furthermore, this     study aims at setting up a clinically relevant biomarker set in human GVHD and immune     tolerance in a discovery cohort.      The objectives of this project are:      1. To define phenotypic, functional and molecular correlates of acute GVHD early after     HSCT/at its onset 2. To study thymic reconstitution and the T-cell repertoire after HSCT     during period 2 3. To identify functional and molecular correlates of immune tolerance in     long-term survivors of HSCT 4. Preparing for biomarker validation into a clinical trial We     propose a prospective analysis of a cohort of 680 patients transplanted from an HLA-identical     sibling donor at Saint Louis hospital. Analyses will be performed during 3 critical,     clinically relevant, periods.        1. Period 1: Analysis at the onset of GVHD, or at the time of engraftment 30 days after          HSCT in patients not developing GVHD. An additional blood sample will also be analyzed          90 days after HSCT.        2. Period 2: Thymic function analysis using measurements of T-cell receptor excision          circles (TREC) will be performed at 6 and 12 months post-transplant for all patients.          T-cell receptor analysis on sorted T-cell populations will be performed by NGS.        3. Period 3: In tolerant patients (patients more than 2 years after HSCT not requiring          immunosuppressive treatment), or in patients still requiring immunosuppressive therapy          after 2 years. We will also analyze the corresponding immune parameters for each donor.      The longitudinal design of this study will allow us to provide an integrated view of GVHD     pathophysiology and mechanisms of immune tolerance in human.      Prospectively identified phenotypic, molecular or functional biomarkers will then be tested,     in a subsequent study, from biological materials prospectively collected within the French     wide CryoStem cohort. Thus, as the final task of this project, we will perform statistical     analyses taking into account confounding clinical variables influencing the outcome (i.e.     GVHD-related death or tolerance). Preparing for a clinical trial will need moving from     classical Bioinformatics analyses into clinically relevant statistical analyses that include     sequential biological measurement in the discovery set cohort. Main points that will be taken     into accounts for this task are the followings;        1. Transplant-related mortality (TRM) can be estimated in the range of 20%; 2year          post-allogeneic HSCT        2. TRM is mostly (even if totally) due to GVHD and its associated immune deficiency        3. GVHD cumulative incidence can be estimated in the range of 40%        4. 80 patients will be prospectively studied and 30 patients will be analyzed (cross          sectional study) for part 3 only.        5. Since GVHD-related mortality and tolerance are mutually exclusive situation the optimal          calculation for the validation cohort can be expected        6. This calculation will be the basis for the proposal of an interventional clinical trial.   "
73842|NCT02319213|"     The purpose of this study is to evaluate the changes of intraocular pressure due to the     increase of intra abdominal pressure.   "
73910|NCT02318329|"     This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will     be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but     not both.   "
73845|NCT02319174|"     The purpose of the study is to help make a lower cost automatic blood pressure monitor device     for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood     pressure monitoring is limited or not available. The study will compare this low cost device     to a commercially available system used for pre-eclamptic women in many United States     hospitals that the investigators will be bringing to Malawi as a part of this study.      The team hopes to show that this lower cost blood pressure machine works well and can help     women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to     use.      70 pregnant women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at     University of Texas Health Science Center Houston. Patient arm circumference will be measured     with measurement tape.      They will be seated upright in a comfortable chair with arm at heart level and an arm blood     pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer     will be placed on the left arm.      The cuff will be inflated and then deflated until measurement concludes. Heart rate will be     measured with tactile arterial palpation.The process will be repeated for a total of up to     nine measurements, alternating between measurements with the automatic blood pressure monitor     and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each     measurement.      The results of this study will help researchers understand the performance and usability of     this device in Malawi and help decide if any design changes are needed.   "
73846|NCT02319161|"     The investigators aimed to investigate the efficacy of calcium channel blockers and beta     blockers for controlling tourniquet induced blood pressure increase in patients undergoing     carpal tunnel operations with IVRA. For this purpose files of patients undergoing operation     under IVRA were retrospectively examined in terms of demographical and hemodynamic variables.   "
73847|NCT02319148|"     The primary objective of the study is to estimate the effects of different strong enzyme     (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose     pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18     subjects that are randomized to 1 of 3 treatment groups. The study is also intended to     determine the safety and tolerability of single-dose PF- 00489791 when it is administered     with steady-state itraconazole, diltiazem, or verapamil.   "
73848|NCT02319135|"     The hypothesis is that the replacement of the standard fludarabine and cytarabine based     therapy by azacytidine could result in an improvement of RFS and OS rates in the experimental     arm. To fulfill the medical needs in such frail and elderly population, improvements in terms     of atileukemic efficacy in the azacytidine experimental arm should be attained without     increasing the therapy-related toxicity or decreasing the patients QoL.   "
73849|NCT02319122|"     The aim of this randomized, stratified, single-blinded study is to compare two home based     strength-training protocols (High Intensity Interval Training and Progressive Resistance     Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in     children with cerebral palsy.   "
73850|NCT02319109|"     This is a prospective, single-center study in healthy volunteers to establish a PT/INR     reference interval for the Microvisk International Normalized Ratio (INR) Test System. The     primary objective of this study is to establish the reference interval for the measurement of     prothrombin time (PT/INR) using the Microvisk INR Test System. The second objective is to     evaluate the safety of the device.   "
73851|NCT02319096|"     Pelvic floor muscle training (PFMT) is the first line therapy recommended by NICE for the     treatment of SUI. Due to poor motivation and compliance only 15-20% of women comply with the     regimen. Whole body vibration (WBV) exercise has been developed as a new modality in the     field of physiotherapy. The Galileo machine is a unique device for applying whole-body     vibration. The investigators are currently using this therapy as an alternative to     traditional pelvic floor muscle therapy. The investigators aim to audit the investigators     treatment of whole body vibration.   "
73852|NCT02319083|"     The E-CABG registry is a multicenter, European registry collecting data on the preoperative     characteristics, treatment strategies and outcome of patients undergoing isolated coronary     artery bypass grafting (CABG).   "
73853|NCT02319070|"     This study is a prospective, single center, observational, 2-cohort study of adult patients     with severe Hemophilia A. There is no randomization procedure and all patients will be     treated as per usual clinical practice. Patients will be followed up for 18 months after     enrolment.   "
73854|NCT02319057|"     The purpose of this study is to evaluate ORM-12741 concentrations in the blood after     different study drug formulations   "
73855|NCT02319044|"     The purpose of this study is to determine the efficacy and safety of investigational medical     products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab     combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of     the head and neck who have progressed during or after treatment with a platinum containing     regimen for recurrent/metastatic disease.   "
73856|NCT02319031|"     The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and     Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic     Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in     this study may have already been treated prior for HCV or may have never received treatment     for their HCV.   "
73857|NCT02319018|"     This phase I trial studies the side effects and best dose of alisertib when given together     with combination chemotherapy in treating patients with gastrointestinal tumors. Alisertib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving alisertib with more than one     drug (combination chemotherapy) may be a better treatment for gastrointestinal tumors.   "
73858|NCT02319005|"     The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in     patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has     been discontinued; patients are being followed-up for safety.   "
73859|NCT02318992|"     The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized     fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C.     difficile associated diarrhea (RCDAD). We will generate a frozen, lyophilized or fresh fecal     microbiota transplantation (FMT) inoculum from well-screened healthy volunteer donors of ≥150     gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors     and recipients will be saved for later metagenomic studies to characterize the microbiome of     the gut in patients before and after FMT.      Donors will be enrolled and screened at the Center for Infectious Disease laboratory for     enteric pathogens at University of Texas School of Public Health (EPDL-UT-SPH) which is     College American Pathologist and Clinical Laboratory Improvement Amendments certified     laboratory. The donors will come from a variety of places, including the University of Texas     School of Public Health. We will screen at least 70 donors to recruit at least 20 qualified     donors.      Recipients All patients to be treated must have a physician who is willing to care from them     after discharge from our facility. Recipients will need to have insurance or be willing to     self-pay for this therapy. Attending physician of recipients/patients will order the FMT and     make clinical decisions related to overall health for his/her patients. All patients     undergoing therapy will be handled as outpatients at either Baylor St. Luke's Medical Center     in the Texas Medical Center, the Digestive Disease Center at Memorial Hermann in the Texas     Medical Center, or Kelsey-Seybold Clinic - Main Campus on Holcombe Blvd. Once the procedure     is completed, the recipient will be transferred back to their original medical treatment     facility or be released to home care under the care of their physician. A gastroenterologist     with privileges at Endoscopy procedure site will perform the FMT via colonoscopy. The Center     for Infectious Disease enteric pathogens laboratory at the University of Texas School of     Public Health will prepare donor stool for administration via a colonoscope. We will screen     at least 120 recipients to recruit 100 qualified recipients.      Evaluation of the safety of FMT and recurrence of clinical symptoms of CDAD will be performed     by the primary physicians and research coordinators from the EPDL-UT-SPH. The primary     endpoint is to evaluate the safety of the FMT (fresh or frozen or lyophilized health donor     feces) for the treatment of patients with 3 or more episodes of RCDAD. A second efficacy     endpoint is to evaluate the recurrence of clinical symptoms and CDAD after initial therapy.     In order to monitor any health effects for safety, participants will be contacted quarterly     for three years following study completion. The recipient will be contacted by the     investigator pre- and approximately 7, 14 and 30 days after the procedure is performed. The     following procedures will be completed: review recipient diary with the recipient to ensure     that the following information is recorded correctly and a fresh stool sample will be     collected from recipient, tested for C. difficile toxins and an aliquot (2 mL) stored at -80C     for future analysis (e.g. microbiome). The recipients will be contacted by phone for their     diarrhea status.   "
73950|NCT02317796|"     A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study     of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes   "
73951|NCT02317783|"     The initial goal of the investigators interdisciplinary group of imagers, oncologists,     neurologists, neuro-psychologists, and biostatisticians is to obtain proof of concept pilot     data for eventual submission of a National Cancer Institute Quick-Trial for Imaging and     Image-Guided Interventions: Exploratory Grant (R10) depending on the results of this pilot     study.      The overall objective is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand     CICI, which effects up to 16 -50% of individuals receiving long-term adjuvant     chemotherapy.2,3 To date there have been few studies examining this problem using     multi-modality imaging techniques to better understand this complex and significant problem.      FDG-PET and MRI are routinely used in clinical practice for the evaluation of cognitive     dysfunction in older populations complaining of memory dysfunction. It is well recognized     that FDG-PET can assist with the differentiation and characterization of various cognitive     disorders due to unique patterns of cerebral metabolism caused by various cognitive and     dementia-causing disorders.4-6 FDG-PET has been studied extensively in dementia research and     has a high reliability in detecting Alzheimers disease (AD) many years before it can be     diagnosed reliably using clinical criteria.4      To the investigators knowledge, there has been only a single small study using FDG-PET and     bolus water activation paradigms in cancer patients complaining of memory problems.7 To date,     there have been no studies using [18F]Flutemetamol as a PET imaging agent to assess the     possibility of increased amyloid plaque burden as a potential contributing factor to the     cognitive deficits and complaints seen in patients experiencing CICI. The novel feature of     this project is in the combined use of [18F]Flutemetamol-PET, FDG-PET, and anatomic MRI to     study a poorly understood but common problem: cognitive impairment in breast cancer patients     treated with chemotherapy.      If [18F]Flutemetamol, FDG-PET, and MRI can provide information on the pathophysiology of this     disorder, it will be an important step in better understanding the etiology of this     phenomenon and possibly other conditions resulting in cognitive dysfunction. These imaging     assessments will make it possible to explore any altered changes in cerebral structure,     metabolism, and amyloid deposition that may be responsible for CICI. This may help to predict     which individuals may be affected by this problem and provide information for eventual     therapeutic strategies to treat this common cancer-associated disorder.      This study will use [18F]Flutemetamol and FDG-PET imaging to assess and quantify the amyloid     plaque burden and cerebral glucose metabolism, respectively, in breast cancer patients     suffering from CICI and correlate those findings with structural changes on MRI. The     [18F]Flutemetamol and FDG-PET scans of these study patients will then be compared to two GE     software databases (CortexID-FDG and CortexID-Flutemetamol) which contain scan data from     healthy control individuals to evaluate for abnormalities in cerebral glucose metabolism and     amyloid plaque burden differing from the values expected for individuals in their age range.   "
73864|NCT02318927|"     The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions     (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication     freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these     two brain regions after surgery will allow for the development of a personalized DBS system     to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG     episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the     optimized device settings.   "
73865|NCT02318914|"     The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers   "
73866|NCT02318901|"     There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for     patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will     be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus     ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC.     There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for patients     with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype     metastatic CRC.   "
73867|NCT02318888|"     The study aims at investigating if icodextrin 4% instilled in abdominal cavity during surgery     can reduce the risk of surgery and hospitalisation for small bowel obstruction in patients     with colorectal cancer. Follow-up data is collected from the Swedish national colorectal     cancer registry.Patients are followed for 5 years postoperatively.The study is a randomized     Swedish multicenter study and planned to include 1,800 patients. A safety control is planned     after 300 included patients.   "
73868|NCT02318875|"     Joints and muscles disorders are common symptoms in the population. They are characterized by     swelling, pain, functional impairment and morning stiffness. These disorders can be really     disabling and painful, affecting the person's quality life. The purpose of this clinical     trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154 subjects     complaining functional discomfort associated to joints and muscles disorders.   "
73869|NCT02318862|"     Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million     adults in the U.S., and it significantly impacts patients' quality of life while imposing     billions of dollars of direct and indirect costs each year upon our healthcare system.     Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal     of this project is to develop a novel, minimally invasive Mucosal Impedance technique for     more accurate detection of GERD while reducing costs.   "
73870|NCT02318849|"     Taking advantage of college students' frequent use of online technology, including social     networking sites (e.g., Instagram a social media site /Facebook a social networking site) and     social media sites (e.g., YouTube), we will create an online intervention that leverages this     technology to engage and educate Asian, Native Hawaiian, Pacific Islanders (ANHPI)students     about a range of topics related to organ donation following death.   "
73871|NCT02318836|"     This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult     subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with     moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic     impairment (Child Pugh score 10 15), and 6 control subjects with normal hepatic function with     mean age, body mass index (BMI), and gender distribution targeted to be similar to the     impaired hepatic function cohorts.   "
73872|NCT02318823|"     The present study aims to evaluate effects of beer (alcohol) on social cognition.   "
73873|NCT02318810|"     Mask ventilation during induction of anesthesia can be improved by administration of     neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask     ventilation; however, muscle relaxants may improve mask ventilation and they do not alter     mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before     testing mask ventilation. We will study different dosages of rocuronium; we assume that     higher dosages of rocuronium will improve mask ventilation compared with lower dosages.   "
73874|NCT02318797|"     Adults with serious mental illness (SMI) frequently have unmet medical needs which place them     at risk for adverse health outcomes. While there are proven ways to manage and/or prevent     serious medical conditions common among this population, information is needed to understand     their impact on outcomes that matter most for patients, particularly in community mental     health centers (CMHCs) where most adults with SMI receive their care and rural areas where     locating and receiving health care services can be challenging.      The investigators will test two promising ways for promoting the health, wellness, and     recovery of adults with SMI. One way will help patients manage their health and health care     through self-management strategies, including the use of a web portal, and peer support     (patient self-directed care) and the other through interactions with nurses during clinic     visits (provider-supported integrated care).      The investigators will compare the two interventions on three primary patient-centered     outcomes (i.e. patient activation in care, health status, engagement in primary/specialty     care). The investigators hypothesize that:        1. Patient self-directed care will result in improvement in patient activation.        2. Provider-supported integrated care will result in greater improvement in frequency in          primary/specialty care visits.        3. Both interventions will result in significant improvements in the three primary          outcomes.      The investigators will collect information from patients, caregivers, and clinic staff at     different points in time during the study. Patients will be asked to complete questionnaires     and additional data on their service use will be gathered. Some patients and providers will     also be interviewed about their experiences with care. The investigators will examine these     data to learn if, how, and why the new services improve outcomes over time. This information     will help us understand patient and other stakeholder views about the services and, if     appropriate, ensure their continued and/or expanded availability.   "
73875|NCT02318784|"     The purpose of this study is to determine if carfilzomib is safe and effective in the     treatment of patients with advanced neuroendocrine tumors.   "
73876|NCT02318771|"     This randomized clinical trial studies radiation therapy and MK-3475 in treating patients     with head and neck cancer, kidney cancer, melanoma, or lung cancer that has returned, has     spread to other parts of the body, or cannot be removed by surgery. Radiation therapy uses     high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as MK-3475, may block     tumor growth by targeting certain cells and causing the immune system to attack the tumor.     Studying the effects of MK-3475 with radiation therapy on the body may help doctors learn     whether it may be an effective treatment for these solid tumors.   "
73877|NCT02318758|"     A study to assess the interaction of acohol and oral treprostinil.   "
73952|NCT02317770|"     This study compares the effect of nebulized lidocaine and lidocaine spray in patients     undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the     procedure between two methods.   "
74815|NCT02306499|"     This study will include cryopreserved sperm from infertile azoospermic men, with proven     diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART     program in Sohag. Patients personal and medical history and socio-demographic data will be     retrieved from their saved medical files.   "
73878|NCT02318745|"     This study seeks to investigate the efficacy and mechanisms of a highly promising Culturally     Informed Family Therapy for Adolescents in preventing the emergence of two important health     disparities in Hispanic youth, namely drug use & HIV and other sexually transmitted     infections (STI). The proposed study is submitted as part of a P60 application entitled     NCMHD Center for Culturally-Tailored Hispanic Health Disparities Research (El Centro), in     response to the NIH RFA-MD-06-002: Establishing Comprehensive NCMHD Research Centers of     Excellence.      This study investigates: 1) the efficacy of the treatment in reducing existing psychiatric,     behavioral and family problems in youth, and 2) the indicated prevention effects of the     intervention on the emergence of drug use and HIV/STI 20 months after baseline. There is a     substantial literature linking disruptive behaviors (i.e., conduct disorder and attention     deficit hyperactivity disorder) and mood instability (i.e., depressive disorders) and family     conflict to the development of the Hispanic health disparities of drug use and HIV/STI.     Conduct disorder (CD), attention deficit hyperactivity disorder (ADHD) and depressive     disorders (DD) will be targets of treatment, as will be the family risk factors (e.g., poor     parenting, family conflict) and acculturation-related stressors, all of which have been shown     to place youth on a destructive trajectory toward deteriorating health.   "
73879|NCT02318732|"     This study evaluates exposure to California's Armed and Prohibited Persons System (APPS) and     risk of future violence and other important outcome events among individuals who legally     purchased firearms in the past but have since become prohibited from owning them. The main     hypothesis is that APPS will be associated with a significant reduction in risk for future     violence among individuals who are directly affected.   "
73880|NCT02318719|"     Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN)     in comparison to placebo   "
73881|NCT02318706|"     Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral     Neuropathic Pain (DPNP) in comparison to placebo   "
73882|NCT02318693|"     This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on     the glucose variability using continuous glucose monitoring (CGM) in Japanese participants     with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with     sitagliptin will be superior to treatment with glibenclamide in the change from baseline in     mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM)     after 13 days of treatment.   "
73883|NCT02318680|"     The study aims to assess whether a follow home visit after discharge of frail elderly     patients from Nykøbing Falster Hospital reduces the risk of readmission within 180 days.      Staff from the hospital ward identifies patients fulfilling the inclusion criteria and refers     the patients to two project nurses at the hospital (follow home team). One of the project     nurses gets the informed consent from the patient, or in case of a patient who is not able to     give informed consent, from the family and general practitioner. The patient is then     randomized to intervention (follow home visit after discharge) or control.      In the intervention group, the hospital project nurse and the patient meets with the     municipal nurse in the patient's home on the same day the patient is being discharged from     the hospital. During this visit the discharge from the hospital and the actual functioning of     the patient in his own surroundings is reviewed, using a structured assessment.   "
73884|NCT02318667|"     The purpose of this study is to evaluate serum soluble human Suppression of Tumorigenicity 2     (ST2) protein, the receptor for IL-33 and a member of the proinflammatory IL-1 receptor     superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic     response to golimumab treatment in subjects with moderate to severe UC who have failed on     prior conventional therapies. The primary endpoints of this study are to correlate serum     soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and     histological activity (Geboes index) of disease.   "
73885|NCT02318654|"     The primary objective of this study is to compare the efficacy of ice pack to topical     eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary     hair removal.      This study is a pilot study designed to determine feasibility of these procedures.   "
73886|NCT02318641|"     Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik,     Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and     automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is     estimated by spectrophotometric analysis of light reflected from retinal vessels and from the     immediately surrounding retina. Oxygen saturation measurements are made on major temporal     arteries and veins. Briefly, the first and second degree vessels are used, with the addition     of third degree vessels in images where peripapillary haemorrhage prevented analysis close to     the optic disc. Vessel segments chosen for analysis are used consistently for consecutive     measurements in the same retina.   "
73887|NCT02318628|"     The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular     health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera     system and the classic carotid-femoral Pulse Wave Velocity (PWV).   "
73888|NCT02318615|"     The purpose of this comparable cohort study is to evaluate the efficacy and safety of     immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema     prevention in breast cancer patients who are undergoing axillary dissection.   "
73890|NCT02318589|"     This Phase I trial will establish the recommended phase II dose of eribulin in combination     with fixed doses of oral irinotecan in adolescents and young adults with relapsed or     refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a     21-day cycle, while irinotecan will be administered orally on days 1-5. Patients will be     assigned an eribulin dose level at the time of enrollment using a 3 + 3 Phase I design.   "
73891|NCT02318576|"     This study seeks to examine whether 12 weeks of home-based computerized cognitive training on     Cognitive Motor Interference (CMI) will improve walking and cognitive function in persons     with MS.   "
73893|NCT02318550|"     The purpose of the registry is to accumulate pre-and post-scan device interrogation data for     the purpose of determining the risk of MRI for patients with implantable devices.   "
73965|NCT02317601|"     The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to     investigate the effect of single-high-dose glucocorticoid on surgical stress response and     postoperative delirium among Elderly hip Fracture Patients undergoing surgery.   "
73895|NCT02318524|"     Fungal infections could play a role in chronic obstructive pulmonary disease (COPD) patient's     exacerbations and in lung function impairment. In fact, Aspergillus fumigatus is often     isolated from respiratory samples, but few data are available about its clinical     significance. Aspergillus colonization could be associated to a higher risk of invasive     pulmonary aspergillosis (IPA), which, in COPD patients, is characterized by a 2% incidence     (probably underestimated) and a high mortality (72 to 95%). Similarly, detection of     anti-Aspergillus antibodies is quite frequent in COPD patients but its significance and     usefulness for aspergillosis diagnosis and follow-up have not been assessed. Furthermore,     several studies suggest a frequent carriage of Pneumocystis jirovecii, reaching 37-55%, with     a higher frequency in the most severe COPD stages and a possible role of colonisation in the     occurrence and progression of COPD.      As these colonization and sensitization phenomena could be related to domestic exposure to     airborne or, for P. jirovecii, to human reservoirs, the investigators set-up a study in order     to (i) Evaluate how domestic exposure to mould or to P. jirovecii could impact fungal     colonization and sensitization frequency in COPD patients, (ii) Study the relationship     between these fungal colonization/sensitization phenomena and lung function impairment in the     course of COPD and (iii) Have a better understanding of mould and P. jirovecii circulation in     the close environment of patients (between airborne, human reservoirs and patients).      In fine, this study will provide data (i) On fungal contamination levels (species and conidia     concentration) of COPD patient's homes in a French region, (ii) On the relationship between     fungal exposure level and colonization/sensitization phenomena, (iii) On the role of fungal     colonization/sensitization in lung function impairment, (iv) To design diagnostic,     therapeutic, and preventive options for the management of COPD patients, taking into account     fungal environmental exposure and colonization/sensitization impact on the evolution of the     disease.   "
73896|NCT02318511|"     This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of     Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups     for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA)     injection - with commonly used injection material and 3) Saline. After treatment, patients     will be followed up to 12 months to evaluate improvements using common pain and function     subscales.   "
73897|NCT02318498|"     Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8 %     of all myocardial infarctions). There are several different causes behind MINCA where true     infarction due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are the     main findings. The underlying diagnosis is often made by clinical findings sometimes with the     help of cardiac MRI (CMR). Investigators have previously shown that it was possible to give     50 % of the patients a diagnosis made by the combination of clinical findings and CMR made in     median 12 days after the acute event. The present study aim at improve the diagnostic     accuracy by an early CMR with latest technique.   "
73898|NCT02318485|"     This project aims to conduct a multicentre human clinical trial to effectively diagnose and     treat limbal stem cell deficiency (LSCD) which can be caused by a number of different disease     processes, all of which have a common denominator, i.e. a loss of the normal functioning     epithelial stem cells of the cornea. A number of different diseases such as aniridia, steven     johnson's syndrome, ocular cicatricial pemphigoid, bacterial keratitis, or chemical and     thermal injuries to the cornea can lead to gradual loss of its functioning epithelial stem     cells. This leads to vascularization of the cornea with surrounding conjunctival epithelium     growing over it resulting in its scarring and opacification. These corneas, since vascular,     no longer retain their immune privilege and prove extremely challenging to the ophthalmic     surgeon. Grafting donor corneas which in normal circumstances (non vascular corneas) would     give excellent results, exhibit high rates of rejection. This can be very frustrating for     both the patient as well as the surgeon. Since there are a number of different contributing     disease pathologies, our estimate is that there are approximately 100 patients per year in     Belgium that suffer from some degree of LSCD. These patients are very often not correctly     diagnosed since this is a relatively new disease first described in 1990 after the discovery     of limbal epithelial stem cells in 1989. The low rates of diagnosis could potentially be     increased by in vivo confocal scanning microscopy as a non invasive screening test to detect     early signs of LSCD and therefore offer conservative treatment options. In the cases where     total limbal stem cell deficiency has already developed, conventional corneal grafting is not     suitable due to the high vascularity of the host bed. In this situation we propose     transplanting standardized limbal epithelial stem cell grafts generated from the patient's     own ocular stem cells (from the good eye, where available) or from HLA matched donors. Tiny 1     by 2mm superficial limbal (peripheral cornea) biopsy can be taken and the epithelial stem     cells expanded in the laboratory on a biological substrate, until there is a graft measuring     >8mm in diameter generated in 2 a week period. This can then be transplanted onto the     diseased eye after removal of scar tissue using a novel surgical technique we have developed.   "
73899|NCT02318472|"     The purpose of this study is to determine whether early mobilization after Achilles tendon     rupture can speed up healing and improve patient outcome.   "
73900|NCT02318459|"     This is a pilot study for evaluating the feasibility of using High Intensity Interval     Training in geriatric hospitalized patients compared to the standard current rehabilitation     practice.   "
73901|NCT02318446|"     The present study is planned to study effect of folic acid supplementation on homocysteine     levels and CV risk factors such as BP and lipids in adolescent epileptics taking     anti-epileptic drugs (AEDs).   "
73902|NCT02318433|"     The primary aim of the study is to see if a single wrist injection (intra-articular) of     dexamethasone at the time of treatment will reduce the incidence of early-onset of post     traumatic osteoarthritis.   "
73953|NCT02317757|"     These days, there is higher proportion of elderly cancer patients. Most of them have     comorbidities, borderline performance status and nutritional status. The discontinuation of     chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric     assessment might be beneficial in selection of suitable elderly patients for chemotherapy     administration.   "
73903|NCT02318420|"     OVERALL OBJECTIVE In an East African referral hospital, to develop and analyze the effect of     locally agreed and achievable guidelines and a continual in-house training program for     strengthening partogram-based monitoring-to-action during labour.      INTERVENTION Paper partograms (WHO), locally developed labour management guidelines (the     PartoMa guidelines) and continual in-house education.      OVERALL DESIGN A quasi-experimental pre-post-study (The PartoMa study).      SETTING Department of Obstetrics and Gynaecology, Mnazi Mmoja Hospital, Zanzibar.      POPULATION Labouring women delivering at the study site from October 2014 to January 2016 and     their offspring, as well as health providers. Women and their offspring will be enrolled     at/after unset of labour and followed until discharge.      ENDPOINTS The primary composite endpoint is stillbirths and birth asphyxia. For further     description and secondary outcomes, please see below.      STUDY TIME Data collection from October 2014 to January 2016, supplemented by a post-exit     collection of case file data from October 2016 - January 2017.   "
73904|NCT02318407|"     This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose     escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects     will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4     doses (Q28D x 4).   "
73905|NCT02318394|"     To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced     solid tumors   "
75080|NCT02303041|"     This pilot trial studies how well sonidegib and buparlisib work in treating patients with     basal cell carcinoma that has spread to other places in the body. Sonidegib and buparlisib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
73911|NCT02318316|"     The most effective treatment of hematologic malignancies and some benign hematological     diseases is allogeneic stem cell transplantation therapy. Pulmonary complications can occur     after allogeneic stem cell transplantation. And these complications effect mortality and     morbidity in these patients. In this study we want to investigate the use of exhaled breath     condensate (EBC) collection which is a simple and completely noninvasive method. By this way     we hope to detect pulmonary complications early. EBC, has been implicated in the     pathophysiology of inflammatory airway diseases such as cystic fibrosis, asthma, chronic     obstructive pulmonary disease (COPD) and bronchiectasis. EBC, has not been investigated     before in patients who underwent stem cell transplantation.   "
73912|NCT02318303|"     Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in     treatment of seasonal allergic rhinitis.   "
73913|NCT02318290|"     Critically ill patients who are mechanically ventilated may require prolonged administration     of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms     upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated     with adverse clinical outcomes. Although well studied in the paediatric population, little is     known about the epidemiology, risk factors and optimal screening methods in adults. Studying     this problem is essential as we strive to develop proper weaning strategies.      Methods: Prospective observational two-center study in critically ill adult patients     Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in     critically ill adult patients and 2) Evaluate the performance of screening tools assessing     withdrawal that were developed for the paediatric patient in the adult population.   "
73914|NCT02318277|"     The purpose of this study is to explore the safety, tolerability, pharmacokinetics,     immunogenicity and preliminary efficacy of INCB024360 administered in combination with     MEDI4736 in subjects with selected advanced solid tumors.   "
73915|NCT02318264|"     This cross over design study will be used to determine the influence of elastic kinesiology     tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected     resisted and weight bearing exercises.   "
73916|NCT02318251|"     The purpose of the present study is to compare two different physiotherapy programs regarding     their effect on stress urinary incontinence.   "
73917|NCT02318238|"     The purpose of this study is to find an alternative to the six minute walk test by validating     six minute step test and four metre gait speed in healthy children. Both tests were     previously validated in adults and are easier to achieve in non-hospital settings.   "
73918|NCT02318225|"     The aim of this study is to assess whether vaginal misoprostol reduces pain during office     hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable     pain.   "
73919|NCT02318212|"     International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT®     for cervical priming prior to induced abortion.   "
73920|NCT02318199|"     Emergence agitation is a frequent complication that can have serious consequences during     recovery from general anesthesia. However, agitation has been poorly investigated in patients     after craniotomy. In this prospective multicenter cohort study, adult patients will be     enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk     factors and outcome will be investigated.   "
73954|NCT02317744|"     This study will test the effectiveness of the combination of Naltrexone and Bupropion     relative to placebo for reducing binge eating in persons with obesity and binge eating     disorder.   "
73921|NCT02318186|"     Abstract      This is a multi-center, open-label pharmacokinetic (PK) study examining the relationship     between the steady-state plasma concentration and dose of treprostinil delivered     intravenously or subcutaneously in children with pulmonary arterial hypertension (PAH).     Subjects will be divided into 5 cohorts by age. A blood sample will be obtained from each     subject at steady state. Additional blood samples will be obtained from a small subset of     subjects with a 15% increase or with at least a 15ng/kg/min increase in dose from steady     state. Samples will be sent to a pharmacokinetic laboratory for analysis. Linear regression     analysis will be used to determine the relationship between the steady state plasma     concentration and drug dose. A power model will be used to assess dose proportionality.   "
73922|NCT02318173|"     International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT®     osmotic dilator for cervical ripening prior to labour induction.   "
73923|NCT02318160|"     Oxidative status in autoimmune thyroiditis was not investigated previously in children and     adolescents. We investigated oxidant and antioxidant systems in a cohort of Egyptian children     and adolescents with AIT to explore their relation with biomarkers of autoimmunity and     thyroid function.   "
73924|NCT02318147|"     Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal     barrier dysfunction and increased intestinal permeability was associated with bacterial     translocation which is believed to prompted these infections.The purpose of this clinical     trail is to observe the potential capability of FMT in reduce the bacterial translocation and     alleviate infectious complications by the reconstruction of a gut functional state.   "
73925|NCT02318134|"     The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis     and protecting the gut against pathogens by competing for nutrients, creating the intestinal     biological barrier and modulating the host immune system.After the onset of acute     pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in     intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and     endotoxin translocation, which may cause infectious complications which are major causes of     death in SAP patients.Recently,FMT was shown its efficacy in the treatment of     gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora     disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the     mechanism by which FMT results in cure of diseases has been poorly understood.This study aims     to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier     dysfunction.   "
74004|NCT02317094|"     This study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol     on patient reported physical function, in patients with sporadic inclusion body myositis. The     study is designed as a parallel group randomized controlled trial with a treatment group and     a control group.   "
73926|NCT02318121|"     Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and     morbidity. Prolonged labour is most often defined as onset of regular , rhythmical painful     contractions accompanied by cervical dilatation where labour is longer than 24     hours.prolonged active phase should not last longer than 12 hours without full assessment in     a facility able to offer management and treatment of complications.Causes of prolonged labour     usually due to poor or uncoordinated uterine action , fetal head malposition , and or     abnormal pelvis either due to bone or soft tissue obstruction.      Arrested or prolonged labor is a frequent indication of cesarean delivery.Prolonged labor is     also associated with increased pain and negative birth experience. Women with a prolonged     first stage of labor have experienced a higher rate of postpartum hemorrhage,     chorioamnionitis and neonatal admission to the intensive care unit.      Caesarean section rates are over 20% in many developed countries and have increased nearly     four-fold relative to the 5% rate observed in the early 1970s. The main diagnosis     contributing to this increase is dystocia or prolonged labor.Data obtained from local     hospital records showed that Caesarean section rate in Assiut University Women's Health     Hospital is 47.96% at 2013.      Dystocia is a term used for delay of labor progress and usually refers to abnormally slow     cervical dilatation.It has been proposed that the partogram should include, as a diagnostic     criterion, a 1 cm/hour line originating at admission. The World Health Organization has     proposed a modified partogram that recommends that active phase be diagnosed only at 4 cm or     more.      Oxytocin augmentation of uterine contractions with or without amniotomy is widely used in the     modern obstetric practice to treat a slow labour, although the timing of oxytocin initiation     and amniotomy may vary widely.This intervention is based on the hypothesis that the most     frequent cause of dystocia is inadequate uterine contraction.      The mechanism by which amniotomy speeds up labour remains unclear it is thought that when the     membranes are ruptured ,the production and release of prostaglandins and oxytocin increases     resulting in stronger contractions and quicker cervical dilatation. I has been found that     early intervention (augmentation versus routine care ) with amniotomy and oxytocin to be     associated with a modest reduction in the risk of caesarean section. Moreover, amniotomy     found to be associated with an increased risk of cesarean delivery compared with women     without amniotomy for shortening of spontaneous labour.      The 3 methods ( Amniotomy, Oxytocin or both) used for augmentation of labor in different     settings without a real conclusion which is better.   "
73927|NCT02318108|"     The purpose of this study is to test the effectiveness and cost effectiveness of an assisted     work process redesign intervention in achieving improved diabetes care in primary care     practices. The strategies that we will test represent a novel method for assisting practices     in developing the skills to overcome clinical inertia and health care system barriers to     improved diabetes care by helping them to implement and use a diabetes registry to identify     needed clinical or preventive services an opportunities for treatment intensification where     appropriate for their patients with diabetes. This is accomplished by helping practices     develop methods for improving the efficiency and effectiveness of clinical care processes     through integration of a diabetes registry into regular clinical practice. This integration     is accomplished through changes in the work processes in the practice setting to ensure that     population health tasks (such as outreach to patients who do not attend scheduled chronic     care visits and systematic identification for follow up of patients who may not be taking     prescribed medication therapies) become a part of the regular work of clinical support staff     and other members of the primary care practice team.   "
73928|NCT02318095|"     This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine     and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy     (HIGRT) in resectable and borderline resectable pancreatic cancer   "
73929|NCT02318082|"     This research study is a way of gaining new knowledge about the treatment for cGVHD that has     not responded to steroids. This research study is evaluating a drug called Interleukin-2     (IL-2) as a possible treatment for cGVHD. In this Phase I study, the investigators are     looking to see if 8- week individual patient dose- escalated IL-2 therapy for cGVHD is safe     and its effects on your immune cells.   "
73955|NCT02317731|"     The purpose of this study is to determine whether patients drinking their bowel preparation     solution with a straw will have improved tolerability for ingestion of their bowel     preparation solution and achieve a higher bowel preparation quality score than patients     drinking their bowel preparation solution without a straw.   "
74226|NCT02314208|"     The purpose of this project is to study the efficacy of three candidate molecules (Xenbilox,     Tahor and Resveratrol) in order to decrease the production of oxysterols by reducing the     synthesis of cholesterol and/or regulate the production of bile acids and/or enabling     neuroprotective action within the motor neuron.   "
73930|NCT02318069|"     The risk for tick borne encephalitis increases in Sweden. Together with an increased     awareness of the possibility to acquire protection by vaccination, this has led to an     increase in the number of doses of the vaccine distributed in Sweden each year - now being     approximately 400.000. The first year, two doses with an interval of 1 month is recommended     for the general population, followed by a third dose approximately one year later and an     additional booster dose three years after the third.      Preliminary results from a previous study showed a higher percentage protected (=titer at     least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished     information). In the same study, there were no differences between those who were vaccinated     0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences     between 2 and 3 doses also in the younger control group.      The investigators therefore aim to confirm results in a new study and to add a group with a     double dose at day 0 and then a single dose at day 30 and 360   "
73931|NCT02318056|"     Specific Aim 1: To determine if one of three burn dressings provides a less painful healing     experience for partial thickness hand.      Specific Aim 2: To evaluate if one of three dressings provides greater functionality during     and after healing of partial thickness hand burns.      Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior     healing results for partial thickness hand burns.   "
73932|NCT02318043|"     Adenosine monophosphate (AMP) may reflect airway inflammation and hyperresponsiveness, but     relationship between AMP and histamine (His, a conventional stimulus) bronchial provocation     test (BPT) in asthma is not fully elucidated.      The investigators aimed to compare both BPTs and determine their usefulness in reflecting     changes of asthmatic symptoms.      BPTs were performed in cross-over fashion, at 2-4day intervals. Cumulative doses eliciting     20% FEV1fall (PD20FEV1), diagnostic performance and adverse events were compared. Patients     with PD20FEV1 lower than geometric mean were defined as responders, otherwise poor     responders. Patients with uncontrolled and partly controlled asthma, who maintained their     original inhaled corticosteroids therapy, underwent reassessment of airway responsiveness and     asthmatic symptoms 3 and 6 months after.   "
74005|NCT02317081|"     Prospective, multicenter, single arm study, to assess the feasibility and safety of the     Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native     vessels.   "
75356|NCT02299440|"     The primary objective of this study is to assess the efficacy of ketamine versus a placebo     for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation,     measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.   "
73933|NCT02318030|"     Adequate control of immunosuppression is critical in preventing graft failure after solid     organ transplantation (SOT) and in avoiding life-threatening viral and malignant     complications. Prolonging patient and graft survival and delaying re-transplantation as     children reach adulthood is critical to optimal use of a scarce resource. This requires     tailoring post-transplant management to the unique needs of the child. Immunosuppression     management is challenging in infants, children and youth. The interval from birth to young     adulthood sees profound changes in physiological processes, body size and immune maturation;     infancy and adolescence are the periods of most rapid and dramatic change. Three pivotal     factors affect immunosuppression control in the child: 1) age-dependent variation in drug     metabolism; 2) developmental changes in immune function with increased childhood     susceptibility to infections, including those caused by viruses; and 3) behavioural changes     in adolescence and young adulthood linked with poor treatment adherence.      This project will identify the most important factors influencing immunosuppression control     across the pediatric age range, from infancy to young adulthood, including age-related     changes in drug metabolism, immune function, and susceptibility to viral infections, as well     as health care system factors affecting treatment adherence. This is the first comprehensive,     multi-organ transplant study to identify age-related biologic and health care systems     determinants of variability in immunosuppression control in children and youth. Results will     inform personalized age-appropriate strategies to improve immunosuppression control and     reduce the unacceptably high graft failure and viral complication rates in this vulnerable     population.      The POSITIVE Study brings together researchers across Canada and is one of 6 projects and 3     cores that constitute the Canadian Institute of Health Research (CIHR) funded     interdisciplinary research program called the Canadian National Transplant Research Program     (CNTRP). The CNTRP is a national program designed to increase organ and tissue donation in     Canada and enhance the survival and quality of life of Canadians who receive transplants. As     a national program, CNTRP provides robust power for pediatric studies that would not     otherwise be possible. While primarily focused on issues unique to a pediatric and young     adult population, this study will interact closely with all other CNTRP projects. These     reciprocal interactions will accelerate new discovery that can be cross-applied in different     populations outside of pre-specified age groups. Interactions will ensure rapid knowledge     transfer, uptake and dissemination into practice. This is the largest national cohort study     of pediatric transplant patients to date in Canada, and it will create a longitudinal dataset     with clinical and biological specimens linkable to transplant registries and provincial     administrative datasets.   "
73934|NCT02318017|"     In the current study, we will administer three widely administered cognitive tasks while     simultaneously measuring electroencephalography (EEG) in ADHD patients before and after     methylphenidate immediate release (IR) treatment compared to placebo. In addition we will     compare the effective connectivity dynamics to normal subjects. Using this novel network     analysis approach, we will attempt to address the currently limited cognitive network     literature. We will attempt to map the connectivity between the discrete brain regions during     the execution of the tasks before and after treatment with methylphenidate IR. Comparison     with healthy control subjects will enable us to determine whether the direction of     methylphenidate induced changes in brain functioning (in youths with ADHD) will be toward or     away from normal connectivity patterns. We will also examine whether network patterns differ     between the healthy controls and the ADHD patients.   "
73935|NCT02318004|"     The aims of the present study are to evaluate the information obtained by the EarlySenese     monitoring system and examine correlation of the obtained data and clinical events.   "
73936|NCT02317991|"     The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab     (Cyramza®) are effective when used in combination for treating patients with metastatic     gastroesophageal cancer who have either progressed or not responded to prior therapy.   "
73937|NCT02317978|"     Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection     (ICSI) in Dar AlTeb sub-fertility center will be reviewed and the follicular sensitivity     index (FSI) will be calculated and correlated with pregnancy.   "
73938|NCT02317965|"     The purpose of this study is to detect whole chromosome abnormalities in maternal blood.   "
73939|NCT02317952|"     The purpose of this study is to determine if a new extensively hydrolyzed formula can be     consumed by children with Cow's Milk Allergy.   "
73940|NCT02317939|"     A two-step multi-centre study with 240 rheumatoid arthritis patients.   "
73976|NCT02317458|"     This study is designed to evaluate the efficacy and safety of the C3BS-CQR-1 in the treatment     of patients with chronic heart failure secondary to ischemic cardiomyopathy.   "
74032|NCT02316730|"     24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric     coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized,     crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1     as detection indicators. Establish the blood drug concentration-time  curve, compare the     bioequivalence of the main effective ingredients of the two preparations during the     absorption process in human.   "
79847|NCT02240784|"     The purpose of this study is to characterize the natural history and clinical management of     Acute Hepatic Porphyria (AHP) patients with recurring attacks.   "
73941|NCT02317926|"     The proposed study design is a prospective, randomized, double-blind, crossover study. After     informed consent is obtained, patients will be randomized to receive either desiccated     thyroid in capsules, or L-T4/L-T3 (ThyrolarTM) in capsules, or L-T4 alone capsules. All study     participants, physician investigators, those administering the neurocognitive tests and those     analyzing test results will be blinded throughout the study.      Subjects will undergo memory testing, a disease specific symptom questionnaire, a general     mental health assessment, a complete physical examination, baseline EKG, and biochemical     testing consisting of serum TSH, free T4, total T4, total T3, free T3, T3 resin uptake,     reverse T3, sex hormone binding globulin (SHBG), serum iodine, a lipid panel, insulin,     glucose and leptin. This testing and DXA scan of body composition will be performed at     baseline and after each 3 month treatment period. Deiodinase type 2 (DIO2) polymorphisms     analyses - will also be performed at the beginning of the study and the results will be     blinded to the investigators performing the memory testing.      After 5-6 weeks on the study medication, TSH levels will be checked and the medication     adjusted to maintain TSH level between 0.46-4.68 mIU/L. Once the TSH level is in the desired     range, subjects will continue the medication for an additional 6 weeks. Subjects will then be     crossed-over to the other treatment arm for 3 months. Again, testing will be performed after     each treatment period. Finally the subjects will again switched over to the 3rd arm and     testing will be performed after treatment period.      A cross-over design is preferred because we are assessing subjective symptoms such as     clinical well-being and other parameters. Therefore, we will be able to evaluate the     effectiveness of L-T4/T3 (ThyrolarTM) vs DTE vs T4 alone in the same patientssubjects. This     is also supported by the previous study by Escobar-Morreale et al.      Additionally, the Wechsler memory scale, DEXA for body composition, measurment of reverse T3,     insulin, leptin, and DIO2 polymorphisms analysis will be included for the research portion of     this study. Further, the frequency of serum blood draws, for research purposes, will be at     intervals of 0, 6, 12, 18, 24, 30 and 36 weeks.   "
73942|NCT02317913|"     To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008     through 2012, and illustrate the risk factors of coronary arterial lesions .   "
73943|NCT02317900|"     Dengue viruses are widespread in most tropical and subtropical regions of the world. This     study will evaluate the safety and protective efficacy of a dengue vaccine (called TV005)     against viremia and rash induced by a DENV-2 vaccine virus (called rDEN2∆30-7169) in healthy     adults.   "
74006|NCT02317068|"     This study aims to determine whether increasing atrial base rate pacing to achieve at least     75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of     dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6     months follow-up duration.   "
73944|NCT02317887|"     Background:      - X-linked juvenile retinoschisis (XLRS) is caused by changes in the RS1 gene. These changes     cause abnormal function of the eye protein retinoschisin. Without normal retinoschisin, the     layers of the retina split and vision is lost. Researchers want to try to introduce a healthy     RS1 gene into eye cells, to see if this helps retinal cells make healthy retinoschisin. They     will put the gene in a virus. The gene and virus package is known as a gene transfer vector     (AAV-RS1 vector).      Objectives:      - To see if the AAV-RS1 vector is safe to use in people.      Eligibility:      - Adults 18 and older with a mutation of the RS1 gene, 20/63 vision or worse in one eye, and     XLRS.      Design:        -  Participants will be screened with genetic tests to confirm XLRS. They will have a          medical history and physical and eye exams.        -  At visits 1-2, participants will have some or all of the following:        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Tuberculosis skin test        -  Eye exam        -  Vision tests (for one test an intravenous line will be placed in the arm. A dye will be          injected that will travel to the blood vessels in the eye).        -  At visit 3, the AAV-RS1 vector will be injected with a needle in the study eye.          Participants pupils will be dilated. They will get numbing eye drops.        -  Visits 4-13 will occur in the 18 months after gene transfer. Many of the above tests          will be repeated. Participants will discuss any side effects.        -  Visits 14-17 will occur yearly between years 2 and 5.        -  After year 5, participants will be contacted yearly by phone for up to 15 years.   "
73945|NCT02317874|"     This phase I trial studies the side effects and best dose of talazoparib when given together     with carboplatin and paclitaxel in treating patients with solid tumors that have spread to     other places in the body or cannot be removed by surgery. Talazoparib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving talazoparib with carboplatin and paclitaxel may kill more tumor     cells.   "
73946|NCT02317861|"     The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK),     safety, and tolerability of multiple doses of RDEA3170 administered in combination with     febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in     Japanese adult male subjects with gout or asymptomatic hyperuricemia.   "
73947|NCT02317848|"     The prevalence of sleep-disordered breathing is common in patients with stable chronic heart     failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS)     and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS is     associated with higher mortality.      CHF is associated with a high rate of re-hospitalization and significant morbidity and     mortality and is considered as a major medical and economic problem. To date, few studies     have investigated the prevalence, severity, persistence and the role of SAS during cardiac     decompensation. For different pathophysiological considerations, it is assumed that SAS is     exacerbated during AHF. Therefore SAS is not conventionally screened during this phase. This     assumption has been questioned recently by some studies which showed stability of the type of     SAS and its severity between the decompensation episode and the stable HF.      Our hypothesis is that SAS during an AHF episode of CHF will remain stable both in terms of     severity and type at three months of decompensation. Thus early polygraphy may be reliable     for identifying HF patients with SAS.   "
73948|NCT02317835|"     To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot     Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.   "
73949|NCT02317809|"     Some women cannot have children because they cannot produce enough follicle stimulating     hormone (FSH) and luteinising hormone (LH). When this happens the ovaries fail to produce an     egg during the menstrual cycle - a condition known as anovulation. Anovulation can be treated     by giving replacement FSH and LH. Pergoveris is a medication that contains both FSH and LH.     It is used for the treatment of anovulation in women who do not produce enough FSH and LH.      A new, liquid formulation of Pergoveris is being tested in this study. It will be compared     with the current freeze-dried marketed formulation to see if the new formulation gets into     the blood stream as easily as the current formulation.      This study will involve 38 healthy female subjects and 2 treatment periods and will last for     approximately 77 days. Each subject will receive a single dose of the new liquid formulation     and a single dose of the current marketed formulation separated by an interval of two weeks     in a randomised (by chance) order. Blood samples will be taken at regular intervals over 2     weeks after each dose to measure levels of FSH and LH.      To participate female subjects must have normal ovaries on internal ultrasound scan, a normal     result from a cervical smear test, be taking the combined oral contraceptive (OC) pill.      Eligible subjects will have their usual OC pill replaced with another called Marvelon     throughout the study. After 14 days subjects will have their levels of FSH and LH checked and     if sufficiently reduced will only then proceed to dosing.      Subjects will then receive one of the formulations. An ultrasound scan of the ovaries will be     performed 7 days later, and another one 7 days later just before the next dose. Subjects     whose ovaries show signs of stimulation will not be given the second dose. The ultrasound     scan will be repeated 7 days after the second dose.   "
73956|NCT02317718|"     Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20     ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular     disease, immune functioning, and glucose metabolism. Recent data from retrospective and     prospective trials have demonstrated contradictive results concerning the role of vitamin D     in female reproduction and IVF outcome. Some studies have found that women deficient in     vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when     compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated     that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of     advanced reproductive age. It may also have a role to play in endocrine dysfunction and     abnormal folliculogenesis in polycystic ovaries .      The aim of this prospective cohort study including infertile women undergoing IVF treatment     is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian     reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and     miscarriage rates .   "
73957|NCT02317705|"     This study is being done to:        -  test the safety of OTL38        -  see if OTL38 helps light up the cancer when viewed with the special camera system        -  test the safety of the special camera system for use along with OTL38 during surgery   "
74007|NCT02317055|"     The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic     resonance imaging on subjects and to correlate the results with near infrared spectroscopy     measurements.   "
75366|NCT02299310|"     The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR     Index in patients with chronic kidney disease.   "
73958|NCT02317692|"     The current pilot study aims to close the existing gap in our knowledge about effective     psychosocial treatments for Latino families by providing preliminary data regarding the     acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators     that will support a future R01. Specifically, the current pilot study is the first step in a     larger program of research aimed at definitively determining if culturally-modified ADHD     treatment outperforms standard treatment when examining engagement and acceptability     outcomes, as well as symptomatology and parental functioning, and if so, which treatment     modifications are necessary and for whom. The following study aims will be examined.        1. Aim 1 is to explore if the culturally-modified treatment results in better engagement          and acceptability outcomes (i.e., parental attendance, retention, engagement, and          satisfaction) than standard treatment and to determine the strength of these effects.        2. Aim 2 is to explore if the culturally-modified treatment results in improvements in ADHD          symptomatology, as well as parental functioning (i.e., parenting stress and efficacy),          to explore if the modified treatment results in similar or greater improvements than          standard treatment, and to determine the strength of these effects.        3. Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and behavioral          and cognitive acculturation) that may explain the relationship between treatment type          (i.e., standard versus culturally-modified) and outcomes and to determine the strength          of these interactions.   "
73959|NCT02317679|"     Pulsed dye laser (PDL) is the gold standard treatment for port-wine stains (PWS). However,     the outcomes are highly variable due to the new angiogenesis occurring after laser     irradiation. Studies suggest that endothelin is involved in the neoangiogenesis that occurred     after treatment of port-wine stains by PDL. The main objective of this pilot clinical trial     is to evaluate the effectiveness and safety of an inhibitor of endothelin orally taken, the     Bosentan, following PDL treatment. Four patients with facial port-wine stain resistant to the     PDL treatment will be included. The treatment by Bosentan (2 mg/kg twice daily, maximum 62,5     mg twice daily) will be given one day before the PDL irradiation and continued for 14 days.     Only one test area of PWS will be treated with PDL. The primary outcome measure will be an     important or complete improvement (Investigator Global Assessment 3 or 4) between treated     area and non treated one, 14 days after the end of the treatment which corresponds to one     month after the laser PDL session. The evaluation will been performed on standardized     pictures by 2 independent physicians blinded to the region treated or not.   "
73960|NCT02317666|"     Older people often use medications with anticholinergic or sedative side effects which     increase the risk of falling, fractures caused by falls and cognitive impairment. In the     Netherlands, medication reviews are done by pharmacists in collaboration with the general     practitioner to optimize medication use and reduce these adverse drug events. To maximize the     benefits of medication reviews it is helpful to identify patients with high risk medication,     yet few appropriate tools are available The Drug Burden Index (DBI) designed in Australia,     calculates anticholinergic and sedative drug burden. This study evaluates whether the DBI can     be used to identify patients with anticholinergic and sedative medication in need of a     medication review. A clustered randomized controlled intervention study will be conducted.     Per pharmacy (cluster), one pharmacist will perform the medication reviews. In each pharmacy,     one half of eligible patients will be randomly allocated to the control group and the other     half in the intervention group. Data will be collected at baseline and at follow-up, 3 months     after the medication review has taken place. The study population includes community-dwelling     patients aged ≥ 65, with polypharmacy (≥ 5 medications) and a DBI value ≥ 1 (n = 190)     selected by 10 community pharmacists. The intervention consists of a structured 5-step     multidisciplinary medication review (STRIP method) as described in the multidisciplinary     guidelines of Dutch General Practitioners performed by the pharmacist in collaboration with     the general practitioner. The main endpoint is the difference in proportion of patients     having a decrease of the DBI ≥ 0.5 between the intervention and control group at 3 months     follow up. Secondary outcomes are anticholinergic side effects, risk of falls, cognitive     function, function of daily activity, hospital admission and mortality. All participants will     be informed about the study and asked to provide informed consent. Data will be processed     confidentially. Only the researcher will have access to the data. If required, the Dutch     Inspection of Healthcare will also be granted access to the data for Inspection. The burden     of patients will be kept at a minimum by trying to retrieve as much information as possible     from patient's medical records and by using questionnaires and tests that were specifically     developed for this population. In the investigators opinion, participation does not involve     risks.   "
73961|NCT02317653|"     The purpose of this study is to identify the influences of pregnancy on breast milk and the     effects of these on the health of babies during the first 2 months of life. The investigators     hypothesize that overweight and obese mothers will have lower serum n-3 to n-6 PUFA ratios     during pregnancy and postpartum than normal weight mothers and will be positively correlated     with TNF-α, IL-1β, resistin, and negatively correlated ghrelin levels both in serum and in     breast milk in postpartum.   "
73962|NCT02317640|"     The aim of this study is to understand what happens to muscle and bone in spinal cord injured     males after four months of training using stand training, with body weight support (BWS),     with testosterone replacement therapy (TRT), and electrical stimulation (ES). Specifically,     researchers will investigate nerve, muscle, and bone changes in the lower limbs in response     to stand training and ES when combined with TRT compared to i) standing alone with TRT; ii)     stand training alone with placebo; iii) stand training alone and ES with placebo.   "
73963|NCT02317627|"     This study is being done to evaluate the safety, tolerability, activity, pharmacokinetics     (PK), and daily dose regimen of KD025 administered orally for 12 weeks to subjects with     psoriasis vulgaris who have failed at least one line of systemic therapy.   "
73964|NCT02317614|"     Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals     infected with HIV, and can reduce the chance of HIV transmission, but a high degree of     adherence to ART is required to achieve these benefits. Unfortunately, only 59% of patients     in North America report ART adherence >90%. Thus, ART adherence interventions are a critical     part of the fight against HIV/AIDS. Injection drug use and crack cocaine use are major     factors in the transmission of HIV, and are associated with non-adherence to ART. Several     types of interventions, most notably directly administered antiretroviral therapy (direct     observation of antiretroviral administration and patient supports) and contingency management     (the provision of incentives contingent upon objective evidence of adherence) have been     effective in promoting ART adherence in drug users. However, a core problem with all ART     adherence interventions is that their effects do not last after the interventions are     discontinued. The common finding of post-intervention dissipation of effects suggests that     ART adherence interventions may need to be long-term or even permanent adjuncts to ART for     drug users. The investigators intend to develop an intensive intervention that incorporates     the most effective techniques for promoting ART adherence in drug users, and delivers them in     a manner that allows for their large-scale implementation as long-term or even permanent     adjuncts to ART. Thus, we will bundle a targeted group of effective component interventions     into a smartphone application that is easy for patients to use, simple to manage, and     maximally convenient for all stakeholders. Our ultimate goal is to produce an intervention     that is highly effective and scalable. Toward that end, the SteadyRX intervention to be     developed under this project will be largely automated and will (1) facilitate consultation     with care providers (2) provide reminders when a dose is overdue, (3) provide electronic     remote observation of medication-taking, and (4) reward ART adherence. In addition to     developing this smartphone-based intervention, a pilot study will be conducted in 50 HIV+     adults with a detectable viral load who use drugs or are in drug treatment. In this study,     participants will be randomly assigned to receive usual care, or usual care plus the SteadyRX     intervention.   "
73966|NCT02317588|"     This study is single site, double-blind, randomized, cross-over study designed to compare the     effects of flax oil and fish oil supplementation on the oxylipin profile in healthy males and     females. Eligible participants will complete two (2) Supplementation Phases (flax oil versus     fish oil) and will be asked to attend 6 in-person clinic visits (0, 1, 3, 7, 14 and 28 days)     for blood and urine collection during each phase. Participants will consume 8 capsules a day     for 28 days containing either A) Flax Oil at 4 grams of ALA per day ,in one phase and B) Fish     Oil at a dose of 4 grams DHA + 0.8 grams EPA per day in the next phase. Participants will be     randomized and blinded and will therefore no know what supplement they are taking in either     phase.   "
73967|NCT02317575|"     This study evaluates four test formulations of a glucose lowering drug (LY900014)     administered by injection under the skin of the abdomen. The study will be conducted in     healthy people to investigate how the human body handles LY900014 and the effect of LY900014     on blood sugar levels. Side effects and tolerability will be documented. The study will be     conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study     will last for about 11 to 12 weeks, including screening and follow up. Screening is required     within 28 days prior to entering into either study Part A or Part B.   "
73968|NCT02317562|"     Primary objective:      To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP     response after an initial 6-month treatment in PRISM study. (I10E-1302).      Secondary objective:      To assess the safety of I10E in this patient population.   "
73969|NCT02317549|"     Septic shock is a potentially life-threatening condition that can result in multi-organ     dysfunction syndrome (MODS) and mortality. LB1148 was formulated to preserve gut integrity     during physiological shock and ameliorate the subsequent autodigestion leading to MODS and     mortality. The purpose of this study in septic shock patients is to determine if enteral     administration of LB1148 will increase the number of days alive without cardiovascular,     pulmonary or renal replacement therapy through Day 28.   "
73970|NCT02317536|"     This study evaluates two L-Carnitine-based products on muscle function in healthy older     adults (55 to 70 years old). These products are suspected to improve muscle function and     possibly promote building of muscle mass. One third of the subjects will be on Carnipure     Product 1, one third will be on Carnipure Product 2 and one third will be on placebo.   "
73971|NCT02317523|"     This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and     Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's     caregivers. Half of participants will receive BA and the other half will receive support and     information.   "
73972|NCT02317510|"     The aim of this study was to compare general anesthesia (GA) and combined (epidural and     spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold     standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer     several advantages over general anesthesia.      Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25     patients). All patients has symptomatic gall stone disease or polyp of gall bladder.     Intraoperative events related to combined anesthesia , postoperative complications, pain     score and duration of operation time will record.   "
73973|NCT02317497|"     Background: Sedation of the intensive care unit (ICU) patient is necessary to relieve the     patient from pain, anxiety and agitation and to enable mechanical ventilation, diagnostic     investigations and invasive procedures. While sedation policy has shifted from deep sedation     to moderate, minimal, or even no sedation in the general ICU, optimal sedation of the     cerebrovascular ICU patient is unclear and controversial.      Method: MOderate vs DEep Regime in NeuroIntensive care SEdation (MODERNISE) is a prospective,     randomized, open, two-center trial. Patients with acute ischemic stroke, intracerebral     hemorrhage or subarachnoid hemorrhage who need to be ventilated are eligible for enrollment.     It is intended to enroll 50 patients per group (n=100). Patients are randomized within 72h     from admission to either moderate sedation as defined by Richmond Agitation Sedation Scale     (RASS) >= -3 or to deep sedation as defined by RASS < -3 for the next 72h, after which     weaning from sedation is aimed for in a stepwise fashion in both groups. If reduction of     sedation is not feasible, patients remain at their respective sedation level for another 12     hours, and sedation reduction is then tried again. Patients are multimodally monitored for     systemic and cerebral parameters (the latter including bispectral index (BIS) monitoring).     The primary endpoint is ICU length of stay (ICU-LOS); secondary endpoints are several     pre-defined variables of the ICU course, feasibility of sedation levels without violation of     pre-defined safety criteria, pre-defined complications, and short- and long-term functional     outcome and mortality.      Conclusion: The feasibility, safety and benefits of moderate as opposed to deep sedation even     in the acute phase of severe cerebrovascular disease needs to be clarified in a prospective     randomized study. Results from this study might change sedation regimes and help prevent     unwanted effects of deep sedation in the brain-injured patient.   "
73974|NCT02317484|"     The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose     Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II     Diabetes under usual care. It is also to investigate and analyze the exploratory influential     factor of ipragliflozin treatment on clinical efficacy and safety.   "
73975|NCT02317471|"     The purpose of this study is to evaluate the safety and effectiveness of autologous gp96     treatment of gastric cancer.   "
73977|NCT02317445|"     Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the     prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the     significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and     upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods:     To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008     to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital.     Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2,     the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the Hp-positive     patients without eradication therapy (Hp+ No Therapy). All patients took 13C urea breath     test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other biochemical     indicators. The investigators explored the correlations of Hp eradication therapy with MACE     (including recurrent myocardial infarction, revascularization and death) and UGIB after 3 to     5 years of follow-up using survival analysis.   "
74008|NCT02317042|"     This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway     Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat     respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper     airway obstruction. The study will be performed in two phases: In a sleep unit and in the     home environment. The new therapy will be compared against two existing ventilator therapies:     Spontaneous Timed (ST) mode and Intelligent Volume Assured Pressure Support (iVAPS).   "
73978|NCT02317432|"     The primary intervention offered through this study is a manualized and culturally adapted     CBT intervention combined with an exercise intervention, administered by trained Community     Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood     symptoms and at risk of disability. In addition to the intervention implementation, the study     examines how to successfully build collaborative research for the provision of evidence-based     mental health and disability prevention treatments for ethnic minority elders in     community-based settings. Thus, the study will evaluate the three components necessary for a     successful intervention: efficacy, since the intervention must work, acceptability among     clients and partnering agencies, and feasibility and sustainability within the organization.   "
73979|NCT02317419|"     This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study     will establish the safety and tolerability profile of RO6927005 and will be conducted in two     parts.      In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single     patient cohorts will be used to investigate increasing doses until a first dose-limiting     toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related     reactions), whichever comes first. At least 3 patients will be enrolled in each cohort     thereafter, which, if required, can be expanded with additional patients. Part B of the study     will consist of a multiple ascending dose phase (multiple patients cohorts - >/= 3 patients)     followed by an extension phase of RO6927005 given in combination with     gemcitabine/nab-paclitaxel.      Preliminary clinical activity will be explored throughout the study. Patients will be treated     until disease progression and/or lack of clinical benefit, unacceptable toxicities,     withdrawal from treatment for other reasons, death, pregnancy or termination of the study by     the Sponsor, whichever comes first.   "
73980|NCT02317406|"     The purpose of this study is to evaluate the effect of the probiotic product on the GI tract     flora composition.   "
73981|NCT02317393|"     The purpose of this study is to evaluate the contribution of the imaging to the expression of     intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the     end of chemotherapy.      The investigators hope that the results of this first stage of the clinical trial come to     consolidate the preclinical results obtained by the investigators team to characterizing the     interest and the strong contribution of the use of a tracer resting on the expression of αvβ3     integrine for the diagnosis of simple necrosed mass at the end of the treatment of a     non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.   "
73982|NCT02317380|"     Background:      - Researchers want to learn about people s beliefs and values. They also want to learn about     how people respond to information about cancer risk. They have created two short studies.     They have combined these studies for convenience.      Objective:      - To learn about people s beliefs and values, and about how people respond to information     about cancer risk.      Eligibility:      - Adults age 40-70 who are overweight, have never had cancer, and have an opposite-sex close     relationship with someone in that age group who is also overweight.      Design:        -  This study will take place online or in a laboratory.        -  Participants will take part in two studies. One is Values Study. The other is Cancer          Risk Information.        -  In Values Study, some participants will choose the most important value from a list.          They will write about why that value is important to them. Others will choose the least          important value from a list. They will write about why that value may be important to          someone else.        -  In Cancer Risk Information, participants will read a health message about a cancer risk          relevant to themselves or to a close other. Some will wear special glasses that track          their eye movements as they read.        -  Participants will then answer questions about their beliefs about cancer risk and their          intentions to lose weight.        -  Both studies will take 30 minutes.   "
73983|NCT02317367|"     Background:      - People respond differently when asked about their values. They also respond differently     when they learn about how their actions affect their lives and health. Researchers want to     learn more about these differences. This can help them improve public health messages.      Objective:      - To see how people respond differently to questions about their values and to information     about alcohol and breast cancer.      Eligibility:      - Women age 18 and older who drink 7 or more alcoholic drinks per week.      Design:        -  This study will take place online.        -  Participants will be randomly assigned to a group that will complete a certain task.        -  Researchers will ask participants to complete 2 small studies:        -  Values Study. Some participants may write briefly about a value that is important to          them or to someone they are close to. Some participants will complete a short          questionnaire instead of the writing exercise.        -  Alcohol and Breast Cancer Study. Participants will read a health message. This will be          about the link between alcohol use and increased breast cancer risk. Participants will          then answer questions about what they read and their beliefs about alcohol and breast          cancer.        -  Both studies should take about 30 minutes.   "
73989|NCT02317289|"     Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian     patients. Our objective is to adapt and extend FOG detectors in order to include other     associated gait pattern changes, like festination.Our purpose is to develop a wearable     assistant which would trigger the most appropriate cueing aid just before occurrence of the     freezing episode.   "
74003|NCT02317107|"     Previous research and position statements have outlined the necessity of balance and gait     testing in the post-concussion evaluation of athletes. However, many of the currently     available balance testing techniques lack objectivity and sensitivity to the effects of     concussion. Such balance impairments may exist following concussion due to disruption of     vestibular and/or ocular motor systems. However, no clinically feasible tools have been     longitudinally examined to detect gait balance control deficits or to investigate how     vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in     physical and cognitive activities post-concussion may affect recovery. While limited evidence     exists to support this notion, further investigation is necessary to improve clinical     management recommendations.      The proposed study will allow for the examination of tools which add value to post-concussion     clinical evaluations and study-related outcomes will enhance the understanding of dynamic     balance control and vestibular/ocular motor recovery, and their potential for implementation     into concussion management protocols.   "
73984|NCT02317354|"     Background:      -X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more     about how people with XLRS choose to take part in research studies. They hope to find ways to     help other people make decisions about joining early phase trials      Objective:      -To learn more about how people think and feel about taking part in early phase research.      Eligibility:      -Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a Phase     I/II ocular gene transfer clinical trial.      Design:        -  Participants will be screened for the XLRS gene transfer study. They will be          interviewed:        -  Eligible participants who join the study - before the gene transfer procedure, then 3          months and 12 months after it.        -  Eligible participants who do not join the study - after their screening visit and 3          months and 12 months later.      <TAB>- Participants who are screened but ineligible - after their screening visit.      <TAB>- Participants who choose not to be screened - at the time they make the decision and 1     year later.        -  Interviews will ask for the participants thoughts about the clinical trial and why they          chose to take part or not. The interviews will be recorded.        -  On the day of interview 1, participants will fill out a survey about their mood and          personality.        -  On the days of interviews 2 and 3, participants will fill out a survey about their mood.        -  Interviews may be done in person or by phone. Surveys can be done online or through the          mail. Or they can be done in person at the NIH Clinical Center.   "
73985|NCT02317341|"     Background:      - Fatigue is a common side effect of cancer and its treatment. No medications can treat this     fatigue. Researchers want to see if the drug ketamine can improve fatigue after radiation     therapy for cancer. They will compare the effects of ketamine on fatigue to midazolam, a     sedative with similar effects.      Objectives:      - To better understand fatigue in people who completed radiation therapy for cancer. To look     at the effects of a dose of ketamine on fatigue.      Eligibility:      - Adults 18 and older who completed radiation therapy for cancer and are enrolled in NIH     protocol 08-NR-0132.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests. They will complete questionnaires about their fatigue and take a breath alcohol          test.        -  The study is divided into 2 phases:        -  During the first phase I visit, participants will have blood taken. They will talk about          their fatigue and other symptoms. They will take thinking and handgrip strength tests.          Then they will get either ketamine or placebo (midazolam) through an intravenous line,          placed by a needle guided by a thin plastic tube into an arm vein.        -  Participants will have a follow-up phone call within 1 day.        -  Participants will have phase I visits 3, 7, and 14 days after infusion. For the 3- and          7-day visits, participants will take thinking and handgrip strength tests. They will          complete questionnaires, talk about infusion side effects, and have blood taken. For the          14-day visit, they will talk about their fatigue and infusion side effects. They will          start phase II that day.        -  Phase II visits are the same as phase I, except that the 14-day visit is over the phone.   "
73986|NCT02317328|"     Background:      - By the time diseases of the retina are detected, serious damage has often already been     done. Researchers want to find better ways of viewing the retina. One way called adaptive     optics may help detect problems earlier.      Objectives:      - To study if adaptive optics can help find better ways to diagnose, treat, and manage     retinal diseases.      Eligibility:        -  People over age 12 with an eye disease.        -  Healthy volunteers over age 12 with 20/20 vision or better.      Design:        -  Participants will be screened with medical history and eye exams. These may include          dilating pupils and taking pictures of the eyes.        -  Participants will have 1 or more study visits. They will have:        -  Medical and eye history.        -  Questions about their medications.        -  Eye exam including pupil dilation.        -  Adaptive optics imaging. After dilation, participants sit still while looking into an          adaptive optics instrument. They look at specific places and images are taken of their          retina.        -  They may also have:        -  More images.        -  Perimetry. Participants look into a lens and press a button when they see a light.        -  Color vision tests.        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses. A          small metal electrode will be put on their forehead. They will look at flashing lights          and try not to blink.   "
73987|NCT02317315|"     Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major     public health concern, reaching 12.9% in 2006, despite intense research to reverse this     trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by     ultrasound are two tests which are proven to have benefit in the identification of those at     greatest risk for preterm delivery. However the benefit of these tests is limited to     situations where a negative result can avoid unnecessary interventions. Currently, maternal     fetal monitoring is limited, as it is difficult to see what is going on in the placenta     (maternal-fetal interface) without invasive measures such as placental biopsy or     amniocentesis. Our goal for this study is to identify a group of biomarkers in non-invasive     compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions) that are     associated with preterm labor and birth. We hypothesize that preterm labor will display an     inflammatory profile, which consists of unique inflammatory biomarkers from different     non-invasive bodily fluid compartments (such as Il-10 in urine, VEGF in cervical secretions,     and IP-10 in saliva), that correlates with a high incidence of preterm birth.   "
73988|NCT02317302|"     In this study, 50 evaluable patients will undergo one FDG-PET study during their     chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment     clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax,     FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and     heterogeneity during treatment will aid in better understanding the role of these biological     parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging,     have evaluated changes in the cervical tumor volume during treatment. The investigators     expect there will be variation in how cervical tumors shrink and change during chemoradiation     and therefore we are going to use multiple measures in addition to tumor volume to evaluate     cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who     are at higher risk for persistent disease following chemoradiation would allow for future     studies where these high risk patients could be specifically targeted with more aggressive     therapy.   "
73992|NCT02317250|"     A substantial portion of people covered by Medicare will develop Alzheimer's disease and     other forms of dementia that together devastate the lives of millions of people in the United     States, and cost us a total of over $200 billion every year. Getting a brain scan with a PET     scanner to look for abnormal brain metabolism patterns is recognized as reasonable and     necessary for some patients with a recently established diagnosis of dementia (Centers for     Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but the evidence is     considered less clear for patients having less severe cognitive problems, and/or for patients     getting a brain scan with a PET scanner to look for abnormal proteins in the brain (CMS     Decision Memo CAG-00431N). This project employs a scientifically rigorous design     (prospective, multi-centered, randomized controlled trial) to determine whether such PET     scanning can help distinguish more accurately than is being done in current clinical practice     those patients with early molecular changes in their brains who will benefit from Alzheimer     related treatments from those patients who will not, as proven by measuring to what extent     the PET scans actually lead to earlier appropriate therapy, and in fact result in improved     outcomes for Medicare beneficiaries and for the health care system in which they obtain care.   "
73993|NCT02317237|"     Patients suffering a stroke with a large vessel occlusion is often treated intra veneous     thrombolyse and on top of that also intra arterial therapy. It is unknown what form of     anaestesia is best during intra arterial therapy. The investigators will randomize these     patients between general anaestesia and local anaestesia. Outcome will be growth of the     ischemic lesion as judged on an MRI scan.   "
73994|NCT02317224|"     Surgery plays an important role in the treatment of anterior mediastinum disease. The major     surgical approaches include: cervical approach, mid-sternal approach, cervical combined     mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is     rarely adopted because of its restricted visual field. The cervical combined mid-sternal     approach have a broader field of vision, given this advantage, the surgeon can remove the     thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is     much larger, and the postoperative complication is also a serious problem. The video-assisted     thoracoscope is often adopted by left or right approach, this minimally invasive procedure     can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators     designed a new method named 3-Hole subxiphoid approach. This study is designed to compare     the safety and validity between this new method and others.   "
73995|NCT02317211|"     Anthocyanins, the water-soluble compounds that make plants appear different colors, have been     shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in     rodents. The purpose of our study is to evaluate a potential protective effect of purified     anthocyanins supplement on type 2 diabetes mellitus patients.   "
73996|NCT02317198|"     A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and     older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized     to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will     be followed for one year for outcomes such as bleeding episode requiring medical intervention     and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal     stroke, PLATO major and minor bleeding).   "
73997|NCT02317185|"     The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone     graft substitute in comparison to autograft, which is considered the gold standard for     posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT     scans geneX® ds has been cleared by the FDA for use in these procedures; however this study     will allow more detailed characterization of geneX® ds performance in the long-term (1 year).     By using the patient as their own control, direct comparison to autograft can be performed     while minimizing other variables.   "
73998|NCT02317172|"     Elderly people usually have systemic diseases and take medications that can cause dry mouth.     The purpose of this study is to determine whether continuous use of edible, gel-based     artificial saliva in geriatric population with dry mouth problems will reduce signs and     symptoms of dry mouth and improve quality of patients' saliva.   "
73999|NCT02317159|"     This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in     patients with chronic phase of Chronic Myeloid Leukemia.   "
74000|NCT02317146|"     There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies     demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take     into account the use of magnesium sulphate before delivery. Termination of pregnancy is the     best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know     the minimum effective dose.The investigators believe that if the patient has received less     than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for     6 hours is as effective as keeping it for 24 hours.   "
74001|NCT02317133|"     The primary objective of this study is to search for evidence of quantitative or functional     defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein     Purpura (HSP) as compared to a control population.   "
74002|NCT02317120|"     Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with     breast/ovarian cancer selected for likeliness to harbor germline mutations in these genes by     specific criteria for high-risk status including age at disease onset.      Secondary objective Considering the fact that BRCA testing is not a routine procedure in     Romania and mutation prevalence varies in different populations, we intend to look for the     founder mutation in our population, running full BRCA genes sequencing to a representative     population sample. This would allow a more targeted approach to real-life practice and would     ensure personalized solutions for every patient in need.   "
74033|NCT02316717|"     This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E     in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.   "
74034|NCT02316704|"     The primary objective of this project is to investigate, using RSA, acetabular implant     migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7     acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the     largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7     acetabular system with endpoint assessment being performed at the 2 year follow-up.   "
74009|NCT02317029|"     Background:      Cardiac arrhythmias can be terminated by electrical current applied by an external     defibrillator. This treatment, named cardioversion, has been used for decades in the     treatment of atrial fibrillation.      Several kinds of defibrillators exist, though the relative efficacy and safety of these     defibrillators is not clear.      During cardioversion, oxygen is being administered, and it has been a long-held belief that     oxygen is always beneficial for the patient. This is now being challenged by recent studies     suggesting excessive oxygenation to be potentially dangerous for the patients.      Objective:        1. To compare the efficiency and safety of two different defibrillators        2. To investigate the effects of excessive oxygen on injury of the heart following          cardioversion.      Experimental design:      Patients will be recruited at the outpatient clinic at the Department of Cardiology, Regional     Hospital of Randers, Denmark as a part of the pre-cardioversion check.      Patients will be randomized to cardioversion using one of two defibrillators and randomized     to treatment with room air or 100% oxygen.      The cardiac condition will be measured by blood samples before cardioversion, 4 hours after     cardioversion and 3 months after cardioversion. Heart rhythm will be measured by ECG before     cardioversion, 1 minute-, 30 minutes- and 4 hours after cardioversion.   "
74010|NCT02317016|"     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase     inhibitor (TKI) agent.      Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of     rosuvastatin, following multiple oral dosing of AZD9291 in the fasted state.      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will     provide for additional safety data collection. All patients from Part A who completed     treatment may continue to receive AZD9291 80 mg once daily as a single agent until: disease     progression; they are no longer deriving clinical benefit; or any other reason.   "
74011|NCT02317003|"     This study evaluates the efficacy, in terms of energy expenditure, physical activity level,     quality of life, blood pressure, waist circumference and weight, of a general practice based     intervention involving a personalised physical exercise medical prescription, the structured     delivery of information on the benefits of physical activity, a pedometer, and a pedometer     log book, in 35 to 74 year old patients with cardiovascular risks factors.   "
74012|NCT02316990|"     Stress ulcers or stress-related mucosal disease (SRMD) is defined as acute superficial     inflammation lesions of the gastric mucosa induced when an individual is subject to     abnormally elevated physiologic demands.[1] Studies have shown that SRMD occurred in     75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication     in critically ill patients. The frequency of clinically important bleeding ranged from 5.3%     to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which     is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of     Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis     in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely     used in China current clinical practice for the prevention of stress ulcer bleeding. However,     there is no epidemiology data to show the risk factors for stress ulcer bleeding and the     bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from     brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know     about the characteristics in Chinese critically ill neurosurgical patients.      Objectives of this Non-Interventional Study Primary        1. Primary objective: To estimate the overall incidence of upper gastrointestinal (GI)          bleeding in critically ill neurosurgical patients in China.        2. Main secondary objective             -  To estimate the incidence of upper GI bleeding with clinically significant               complications in critically ill neurosurgical patients in China.             -  To estimate the incidence of any overt upper GI bleeding without clinically               significant complications in critically ill neurosurgical patients in China.             -  To assess time to upper GI bleeding after a cerebral lesion.             -  To investigate potential risk factors associated with upper GI bleeding, and assess               how common certain risk factors occurred in upper GI bleeding patients.             -  To assess the overall incidence of upper GI bleeding in critically ill patients by               different risk factors for upper GI bleeding.             -  To investigate the drugs, the route of administration, the doses and the duration               commonly used for stress ulcer prophylaxis.             -  To investigate the proportion of ICU patients with nasogastric tube, and the               duration of nasogastric tube.      (ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)   "
75068|NCT02303197|"     This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer     patients with radioactive stomatitis. Half of participants will receive ChiNing decoction,     while others will receive recombinant human epidermal growth factor (rhEGF) spray.   "
74013|NCT02316977|"     The aim of the study is to establish the intrarater-reliability, criterion validity and     responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients     diagnosed with rheumatoid arthritis.      The study is designed as a repeated test-retest study including 240 patients filling in the     ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a     home-module in the DANBIO database) which makes it possible for the patients to complete     their assessments and send information from their own home.      Intrarater reliability will be assessed by calculating the intraclass correlation     coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and     responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used     to classify participants based on pain phenotype to explore any relationship between pain     phenotype and reliability.   "
74014|NCT02316964|"     This pilot trial studies decitabine, donor natural killer cells, and aldesleukin in treating     patients with acute myeloid leukemia that has come back after previous treatment (relapsed)     or has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as     decitabine, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving donor     natural killer cells after decitabine may boost the patient's immune system by helping it see     the remaining cancer cells as not belonging in the patient's body and causing it to destroy     them (called graft-versus-tumor effect). Aldesleukin may stimulate natural killer cells to     kill acute myeloid leukemia cells. Giving decitabine, donor natural killer cells, and     aldesleukin may be a better treatment for acute myeloid leukemia.   "
74015|NCT02316951|"     This pilot study will seek to use emotion recognition technology from video to link patient     facial expressions, heart rate and respiratory rate changes, and movement patterns to patient     pain scores.   "
74016|NCT02316938|"     CRAD001AAU13 is a substudy of CRAD001A2433. The core study CRAD001A2433 is a 2-year,     randomized, multicenter, open-label, 2-arm study evaluating graft function with everolimus     and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.     Patients in this study may use cyclosporine or tacrolimus as the CNI.   "
74073|NCT02316197|"     This study is to explore the safety, tolerability, pharmacokinetic and pharmacodynamic     profiles, and clinical activity of M3814. This study is divided in following 3 parts: Part A     - Monotherapy Dose Escalation, Part B - Combination Therapy Dose Escalation, Part C -     Combination Therapy Expansion   "
74017|NCT02316925|"     A randomized, double blind placebo-controlled parallel intervention in adults over the age of     50 will be performed. Participants will receive a supplement capsule containing placebo     (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is     hypothesized to replenish the body's reserves that may be depleted through natural aging     process, poor diet, or due to the detoxification process for drugs. The primary end point is     the number of healthy days experienced during cold and flu season. Secondary endpoints     include cellular and biochemical measures from blood samples taken before and after the     study.   "
74018|NCT02316912|"     First in man evaluation of single and multiple doses of compound ATX2417 in healthy male     volunteers. A double blind placebo controlled parallel group ascending dose design; up to     five dose levels for the single dose and up to two dose levels for the multiple dose (8 days     of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial     and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and     pharmacokinetic profile. A fasted/fed comparison will also be included in the single     ascending dose part of the trial.   "
74019|NCT02316899|"     The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients     with constipation predominant irritable bowel syndrome (IBS-C).   "
74020|NCT02316886|"     The purpose of this study is to determine whether preventive coronary intervention on     functionally insignificant coronary stenosis with vulnerable plaque characteristics plus     optimal medical therapy reduces the incidence of the composite of cardiovascular death,     target vessel myocardial infarction, or ischemia driven target lesion revascularization     compared with optimal medical therapy alone.   "
74021|NCT02316873|"     The purpose of this study is to determine whether music training is an effective treatment of     reading disorders   "
74022|NCT02316860|"     In the present study the investigators evaluate the sensitivity and specificity of passive     tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system     activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for     the improvement of diagnostic yield of tilt test in athletes.   "
74023|NCT02316847|"     This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray     in adolescents and adults with cluster seizures, with a focus on potential local effects     (changes in nasal mucosa, olfaction, and taste).   "
74024|NCT02316834|"     The goal of this clinical research study is to learn about the effects of BMN 673 on ovarian,     Fallopian tube, and peritoneal cancer. Researchers want to find out if certain     characteristics of the DNA (the genetic material in cells) affect how the disease responds to     therapy with BMN 673 and if treatment with BMN 673 affects the genetic material in cancer     cells.   "
74025|NCT02316821|"     The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney     disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when     this compound is administered once daily for 16 weeks in an intrapatient dose escalation     design.   "
74026|NCT02316808|"     Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.     LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well     known.   "
74027|NCT02316795|"     The NIR light source of our device is based on light-emitting diodes (LEDs), which can     deliver sufficient light to biological tissues and induce fluorescence emission to meet the     needs of the planned clinical studies. It should be noted that the light source is still well     under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light     source is not laser-based, which is significantly safer than other optical imaging systems     utilizing laser technologies. The fluorescence signals will be received by the detector     portion of our device. Gain-settings could be easily adjusted during operation to optimize     the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal     tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on     a secondary monitor to facilitate viewing by other surgeons in the room.   "
80001|NCT02238743|"     The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome     data following the completion of a hands-on proctorship training model in laparoscopic     ventral hernia repair.   "
74035|NCT02316691|"     Thyroid eye disease (TED) is an autoimmune inflammation of the orbital tissues that develops     in up to 50% of patients with Graves' disease. Although about 80% respond to IVGC initially,     the relapse rate is high and about 75% require further surgery despite initial response.     Although the natural history of TED is associated with spontaneous remissions after about 1     to 3 years, many irreversible serious ophthalmic and orbital complications can arise during     this time. Therefore, there is a need for improved intervention strategies in the early     active inflammatory phase of TED, to avoid progression to the cicatricial stage where disease     manifestations can only be addressed in a rehabilitative fashion. The primary     immunopathogenesis of Graves' disease is considered to be activation of B cells that then     produce autoantibody against thyrotropin receptors in the thyroid (TRAb). Like in many     autoimmune diseases, the inflammatory CD4+ T cell subset known as Th17 cells is also     increased in blood of patients with active Graves' disease; the putative Th17 cytokine,     IL-17, is also increased in serum and tears of TED patients. There is also an emerging     pathogenic role for Th17 cells that co-express the chemokine receptor CXCR5 and drive     autoantibody production. The contribution of Th17 cells to TED is not well defined. This     study is an observational, longitudinal, prospective study of patients receiving treatment     for thyroid eye disease.   "
74036|NCT02316678|"     The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis     factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious     infections, and reduced short term mortality risks, and therefore has a more favorable     benefit to harm profile than corticosteroids for inflammatory bowel disease.   "
74046|NCT02316548|"     This randomized phase II trial studies the side effects and how well postoperative intensity     modulated radiotherapy works after surgery in treating patients with urothelial bladder     cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the     pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more     effective than surgery alone in treating patients with urothelial bladder cancer.   "
74037|NCT02316665|"     Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal     glycemia in patients having type 1 diabetes and sleep apnea syndrome.      Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in     type 1 diabetic patients and that continuous positive airway pressure treatment will permit     to improve the nocturnal glycemic profile.      Study design: Adult patients with type 1 diabetes will be recruited for an extensive study of     sleep habits and assessment of sleep breathing disorders. When patients will present with     severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient     glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway     pressure treatment or sham-continuous positive airway pressure treatment group for three     months.      Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three     months of the allocated treatment.   "
74038|NCT02316652|"     The purpose of this study is to determine whether the adjunctive use of chemical pocket     disinfection with scaling and root planing is more effective than scaling and root planing     alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing     (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical     pocket disinfection with scaling and root planing will have an effect on biomarkers of     inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to     scaling and root planing alone. The chemical pocket disinfection therapy consists of     delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to     the test site.   "
74039|NCT02316639|"     Recently, there has been a dramatic rise in the number of children participating in     competitive sports. Adolescents involved in sports that require cutting, pivoting or body     contact are at greatest risk for sustaining an anterior cruciate ligament (ACL) rupture of     the knee, however, appropriate management remains controversial. The surgical technique is     commonly performed in the adult population has been associated with risks for growth     disturbance when performed on skeletally immature individuals. Therefore, the recommended     standard of care in children is to initially follow a non-surgical management protocol that     allows a patient to skeletally mature prior to ultimately receiving surgical reconstruction.     Unfortunately, current non-surgical management protocols are ineffective at enhancing knee     joint stability and dynamic function. There has been no research to indicate the most     appropriate exercise program for the ACL deficient skeletally immature individual. A     neuromuscular exercise program proven to be safe and effective in the ACL deficient adult     population is perturbation training. In adolescents, research suggests neuromuscular     exercises can reduce the rate of ACL injuries by 50%. However, currently there is no research     investigating the benefits of a neuromuscular exercise on the management of a skeletally     immature ACL-deficient individual. The results of this investigation will provide researchers     and clinicians valuable information on the effect of neuromuscular perturbation exercises on     knee joint stability and function immediately following injury. This has the potential to     minimize the development of secondary meniscal tears and premature joint degeneration     commonly demonstrated following an ACL injury.   "
74040|NCT02316626|"     It is well known that implantation of the developing blastocyst occurs during the luteal     phase of the menstrual cycle when the endometrium is under the direct influence of     Progesterone (P).Several prospective randomized controlled trials have evaluated the benefits     of luteal phase P support in ovulation induction cycles and a recent review and meta-analysis     demonstrated that it may be of benefit to patients undergoing ovulation induction with     gonadotropins in intrauterine insemination (IUI) cycles. Until now, injectable P was offered     only in an oil-base solution owing to the insoluble properties of the molecule, which made     the IM route mandatory. A recent publication, however, demonstrated the efficacy of a new P     formulation that could be a game changer. The aim of the present pilot trial will be to     compare the efficacy and tolerability of 25 mg/d of the new SC P with 90 mg/d of vaginal gel     P for luteal phase support (LPS) in COH and IUI cycles.   "
74041|NCT02316613|"     This French national, multicenter, prospective, longitudinal, observational study will     describe the treatment modalities of a cohort of patients with relapsed or refractory     follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the     presence or not of MabThera® (rituximab) maintenance therapy. Actively participating     physicians will enroll patients and collect therapeutic management data in a real-life     setting up to 5 years.   "
74055|NCT02316431|"     Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary     tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios     will be evaluated to create imaging protocols which are time efficient and diagnostically     accurate.   "
74042|NCT02316600|"     The investigators aim is to evaluate an instrument for supporting physical activity and     monitors multiple parameters of frailty (a pre-disability condition) in frail elderly     persons. The investigators are therefore developing a smart shoe insole to monitor key     parameters of frailty during subject daily life and to promote walking. Our primary aim is to     assess the acceptability of the solution for the follow up and the motivational coaching of     frail patients at home. Results from this study will also be used to elaborate the design of     a further larger national multicenter randomized control trial assessing the efficacy of the     solution to prevent disability.   "
74043|NCT02316587|"     This observational cohort study studies the impact myocardial fibrosis has on patients with     severe aortic stenosis undergoing aortic valve replacement.   "
74044|NCT02316574|"     Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based     psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural     mechanisms through which CBCST changes drinking behavior, it may be possible to improve its     efficacy. CBCST promotes abstinence by teaching coping skills for managing alcohol-related     thoughts and emotions. In this pilot study, the investigators examine the neural systems that     play a role in the learning of coping skills through CBCST, specifically focusing on the role     of emotion regulation systems.   "
74045|NCT02316561|"     The purpose of the study is to investigate the feasibility of a preoperative, single dose,     ablative partial breast radiation treatment in patients with early-stage breast cancer.   "
74071|NCT02316223|"     A 3-arm, patient-randomized trial among Latino and African-American older adults with     poorly-controlled asthma will be conducted to compare the effectiveness of clinic-based vs.     home-based asthma care coordination / self-management support (CC/SMS) vs. usual care.   "
74047|NCT02316535|"     Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years     old. However, compared with younger patients, elderly patients were often undertreated in     chemotherapy due to their impaired tolerance. Recently, there have been great controversy on     adjuvant chemotherapy strategy for stage II/III CRC patients. As an oral fluoropyrimidine,     capecitabine has been demonstrated to be equivalent to i.v. 5-Fu/leucovorin regimen in stage     III CRC patients. In light of fewer adverse effects and better flexibility, capecitabine was     regarded as an ideal alternative for elderly CRC patients, but the optimal dosage for stage     II/III elderly CRC patients still remains inconclusive. Our trial expected to prospectively     randomized 710 postoperative stage II/III elderly CRC patients (between 70 and 90 years of     age) to adjuvant mono-chemotherapy with a standard dose of capecitabine (2500 mg/m2/day) or a     reduced dose (2000 mg/m2/day). This is a non-inferiority phase 3 trial with a primary     endpoint of 3-year disease free survival (DFS), and other outcomes include 3-year overall     survival(OS), completion rate, toxic and adverse effects and quality of life(Qol). By this     trial, we aimed to achieve more precise evidence on the individualized adjuvant chemotherapy     strategy for stage II/III elderly CRC patients.   "
74048|NCT02316522|"     The main objective is to study the epigenetic contribution to the pathophysiology of diabetic     nephropathy in Qatari population.   "
74049|NCT02316509|"     This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity     study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen     Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The     study will be conducted in two parts: Dose escalation and Dose expansion. During dose     escalation, GDC-0927 will be administered orally as a single dose on Day -7 for PK evaluation     during the lead-in period. Depending on safety and tolerability, participants will be     assigned sequentially to escalating doses of GDC-0927 using standard 3+3 design. During dose     expansion, there will be no PK week lead-in period. All participants will be treated until     disease progression, unacceptable toxicity, participant withdrawal of consent or study     termination.   "
74050|NCT02316496|"     The main objective of this study is to evaluate the objective response rate at two months     (complete disappearance of the disease and partial disappearance of the disease) obtained     after administration of combination therapy with cetuximab and irinotecan in the patients     with metastatic colorectal cancer.      Secondaries objectives will be assessed progression-free survival, overall survival,     toxicity, quality of life.   "
74051|NCT02316483|"     To assess the hypothesis that Charcot foot is associated with more vascular complications     compared to matched diabetic patients without Charcot foot and to classify patients with     Charcot foot according to the human genetic classification of the Qatari population.   "
74052|NCT02316470|"     Phase 2, randomized, observer-blind, placebo-controlled, multi-centric study including 4     parallel study groups.      500 Subjects (thereof, 250 aged 50 - 64 years and 250 aged 65 years and older) will be     randomized in a (3:3:3:1) ratio to receive either VLA84 75 µg w/o (without) Alum, VLA84 200     µg w/o Alum, VLA84 200 µg w/ (with) Alum (150 subjects each), or placebo (50 subjects), as     i.m. (intramuscular) vaccinations into alternating arms, on Days 0, 7 and 28   "
74053|NCT02316457|"     The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduces a novel concept for     Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and     immunogenic RNA vaccines for a given patient's tumour. The TNBC-MERIT trial uses two     complementary strategies, the IVAC® WAREHOUSE and the IVAC® MUTANOME concept, resulting in     two custom-made IVAC® investigational medicinal products (IMPs) (IVAC_W_bre1_uID and     IVAC_M_uID) for each individual patient.   "
74054|NCT02316444|"     The aim of this study is to compare the effectiveness of two vaccination strategies against     Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV).      Researchers plan to determine the optimal vaccination strategy for achieving protective     immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic.      Primary objectives are to assess:        1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response.        2. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response.      The secondary objective is to evaluate whether lack of HAART is associated with high rates of     loss to follow-up.   "
77313|NCT02273882|"     Purpose of this study is to evaluate clinical, humanistic and health economic burden of     Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA)     hospitalized for RSV at up to 12 months of age.   "
74056|NCT02316418|"     The aim of the study is to provide evidence of safety and preliminary performance of the     Hairstetics™ anchoring system in female subjects affected with androgenetic alopecia (female     pattern hair loss; (FPHL)).      The study will also help to determine whether the Hairstetics™ anchoring system, in     conjunction with attachment of hair extensions, is efficacious in improving patient and     physician aesthetic satisfaction with the treated scalp appearance in female patients with     androgenetic alopecia.   "
74057|NCT02316405|"     It has been found that arm and leg cycling is similar to walking. Thus, the objective of this     research is to determine if arm and leg cycling can be used to improve walking ability in a     post-stroke population. This outcome would directly impact the health and quality of life for     those who have suffered a stroke.   "
74058|NCT02316392|"     This study is a prospective, non-randomized, longitudinal, observational study that will     recruit about 5 lung transplant patients per year for 3 years.   "
74059|NCT02316379|"     The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas     MRI for regional assessment of lung function in a normal population of adults for the     purposes of obtaining optimal images through MRI.   "
74060|NCT02316366|"     The purpose of this study is to determine if warming the intravenous (IV) fluid given to     patients with Sickle Cell Disease who are experiencing painful episodes known as     Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV     pain medications given, improve pain and improve global comfort.   "
74072|NCT02316210|"     This study aims to facilitate further optimization of a neuromuscular electrical stimulation     device for use in patients whom are suffering from oedema and neuropathy   "
75458|NCT02298114|"     Neuromuscular electrical stimulation in pectoral muscles (fibres of the pectoralis major     muscle bilaterally) and rectus abdominis muscles (bilaterally) preserves / decreases the loss     of muscle mass.   "
74061|NCT02316353|"     The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in     preventing hereditary angioedema (HAE) attacks when it is administered under the skin of     subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks.     The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the     treatment phase, wherein subjects will be randomized to treatment with either low- or     medium-volume C1-INH. Subjects who have an insufficient treatment response during the study     will be given an opportunity to undergo a dose increase. The study aims to enroll eligible     subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in     study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the     United States (US) who complete Treatment Period 2 will be allowed to participate in an     Extension Period. During the Extension Period participating US subjects will continue to     receive treatment with open-label CSL830 for up to an additional 88 weeks.   "
74062|NCT02316340|"     This will be a randomized phase II clinical trial of patients with histologic documentation     of metastatic colorectal cancer, who have received local and currently approved standard     therapies, excluding RGF.   "
74063|NCT02316327|"     RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing     pre & post treatment tumour volume by means of studying changes in the diameter of the     selected target lesions by RECIST. The introduction of new targeted drugs creates the need of     a different response assessment. Functional imaging techniques are able to study in vivo     physiological processes of angiogenesis. Therefore, dynamic techniques may be more     appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is     focused on tumor's vasculature normalization. Preliminary studies have demonstrated     significant and very early changes in indirect vasculature parameters such as flow, blood     volume and tumor perfusion with vascular-targeting agents. These techniques may be useful for     selecting patients who are going to benefit from antiangiogenic therapy by an early     evaluation of response by means of functional imaging method.      PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive     value and early radiologic response or perfusion computed tomography (CT) in patients     diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated with     bevacizumab in combination with chemotherapy.   "
74064|NCT02316314|"     Friedreich's ataxia (FRDA) is an autosomal recessive disease characterized by loss of     coordination and cardiomyopathy. It is the most common form of inherited ataxia with an     incidence in 1/50,000 in the Caucasian population. FRDA is associated with progressive damage     to the nervous system, resulting in symptoms ranging from gait disturbance to speech     problems, as well as diabetes and heart disease. The heart disease manifests as     cardiomyopathy, and is responsible for approximately 60% of deaths from FRDA. This study is     designed to characterize the cardiac manifestations of the disease using exercise, MRI, ECHO     and serum parameters, in the context of the neurological disease.   "
74065|NCT02316301|"     The aim of this study was to determine whether misoprostol administered 12 hours before     office hysteroscopy can relieve pain more effectively compared with misoprostol administered     3 hours before office hysteroscopy.   "
74066|NCT02316288|"     Chronic pain is a costly public health problem that is associated with poor quality of life.     Previous research has demonstrated extensive evidence showing that pain coping is not     manifested by patients in isolation but within the context of significant relationships such     as marriage. For instance, a partner may avoid or reject their partners' negative emotions     about pain, provide unempathic responses to their partners' pain, or change their thoughts     about pain. The patient's pain experience and the couples' relationship also have a cyclical     relationship, in which both can affect each other and the overall quality of life for both     partners. Currently, current clinical practice does not target both partners to alleviate     pain. This is highly problematic given that a number of chronic pain patients—those with     interpersonal distress—often do not complete, and thus, do not benefit fully from existing     treatments. Even if treatment is completed, individuals may not maintain improvements if they     return to distressed social environments that undermine individual coping efforts. Thus, it     is clear that new interventions derived from integrative models of individual and dyadic     coping are needed to alleviate pain and suffering in patients who are at risk for poor     treatment outcomes. This research study aims to develop a novel psychological intervention     aimed at couples in which one partner has chronic pain. Our central hypothesis is that a     theoretically integrative intervention that improves both partners' psychological flexibility     (i.e., acceptance, mindfulness, values-based action) and relational flexibility (i.e.,     emotional disclosure, empathic responding) skills will be feasible and valid and that it will     alleviate pain and improve quality of life. This is a departure from current practice, which     focuses solely on the patient's individual functioning, does not address the spouse's     psychological inflexibility, and does not address relationship issues.   "
74067|NCT02316275|"     To determine the impact of unrestricted postoperative activity on intermediate- and long-term     continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence.      To assess the natural return to baseline activity level when patients are unrestricted     following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic     organ prolapse repair.   "
75795|NCT02293720|"     A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the     EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from     study #09-1 who are not treatment failures and have completed 12 months of the study.   "
74068|NCT02316262|"     Subjects are being asked to participate in this study because they have an arm or leg     amputation and have developed pain related to a neuroma (an ongoing localized pain related to     a cut nerve ending).      The investigators are studying how targeted reinnervation (TR) helps to both treat neuroma     pain and to have increased prosthetic control. This surgery connects these cut nerve endings     to nerves going into nearby nonfunctional muscles. This surgery was developed to allow     amputees to have better prosthesis control. By chance, neuroma pain improved significantly     with TR. The investigators, therefore, are conducting this clinical trial. The investigators     will ask all participants to fill out a questionnaire both before and after surgery. This     will help us understand how a neuroma affects the quality of life of amputee will allow us to     understand how to best improve neuroma pain and prosthesis control.      In order to confirm the presence and location of the neuroma before surgery, a magnetic     resonance image (MRI) will be performed. Taking these pictures requires subjects to lie still     for a short period of time but does not involve any invasive procedures.   "
74069|NCT02316249|"     To compare the use of Estrace ® vaginal cream against a placebo vaginal cream in reducing     symptomatic vaginal discharge and vaginal erosion in patients who are using the Gellhorn or     Ring with support pessaries.   "
74070|NCT02316236|"     The study is to observe whether dexmedetomidine could reduce agitation during emergence from     general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.   "
74074|NCT02316184|"     Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have     been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to     determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol     reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants     will receive BA delivered by their HIV PCP during a regular HIV visit and will then be     randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral     Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking     check-in (MI or BA) sessions will then be provided telephonically every three months for 18     months, with a final assessment at 24 months. Our primary outcome is drinks per week.   "
74075|NCT02316171|"     The study will consist of 2 sequential parts. Part A is a study of the safety and     tolerability of CAVATAK administered via intravesical instillation in patients with     non-muscle invasive bladder cancer scheduled to undergo TUR. Part B will evaluate the safety     and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C     in the same patient population.   "
74076|NCT02316158|"     The overall aim with the project PsYoungSupport is to evaluate Internet and communication     technology (ICT) health efforts, i.e. information, education and support for young adults     (16-25 years) who are first degree relatives or represent the close social network (relative     or close friend) of individuals with mental illness, with regard to the process (the quality     and usefulness of the support) and the effect (on health and quality of life, situation as     relative or part of close social network and consumption of other support/care) of the     intervention.      The participatory design is one of the foundations of this project, and young adult     participants will be consulted through out the research project. PsYoungSupport is a research     program comprising three phases, Phase I is a survey of young relatives' and close friends'     needs for internet based information, education and support, Phase II is the development of a     website, and Phase III is an intervention based on the previous phases. The aim of phase III     is to evaluate the effect of an internet based intervention containing information, education     and support for young adults in families where a family member suffers from mental illness or     functional disability. The participants (N=400) will be randomised to two groups with     different kinds of support. The participants will be evaluated using self-questionnaires and     web interviews at the following occasions: baseline at the start of the intervention, after 4     months and after 8 months. This project will have implications for persons suffering from     mental illness as well as for their relatives and close friends.   "
74077|NCT02316145|"     Purpose: To develop a model for internet-based support and coaching to young adults with     neuropsychiatric disorders (NPD). To improve the individual's psychosocial functioning and     his/her understanding of how he/she is functioning.      NPD comprise problems with social interaction, attention, impulse control and hyperactivity.     The most common NPD diagnoses are ADHD (attention deficit hyperactivity disorder), autism     spectrum condition (ASC) and Tourette's disorder (TD). In this study the investigators use     Internet-based treatment for young adults with NPD.      Method: Support/coaching by using communication over the Internet (chat and e-mail) with     individuals with NPD. Twice every week during 8 weeks, young adults with NPD are offered     support and coaching over the Internet by psychologist/educational therapist with great     experience from NPD. The individuals are assessed before and after treatment pertaining to     quality of life, sense of coherence, self-esteem, depressive and anxiety symptoms, and     parents' evaluation of the young adult's situation.   "
74175|NCT02314871|"     The aim of this study is to compare the effects of three types of perioperative analgesia on     the number of circulating cancer cells (representing minimal residual disease) following     radical colon cancer surgery. Patients will be randomized into one of three groups. The     intervention group will receive combined regional and general anesthesia during surgery and     postoperative epidural analgesia. The two control groups will receive balanced general     anesthesia and either morphine-based or piritramide-based postoperative analgesia. We     hypothesize that epidural analgesia will be favorable to both piritramide-based and     morphine-based analgesia and that piritramide-based analgesia will be favorable to     morphine-based analgesia with regard to the number of circulating cancer cells and its     development in the early postoperative period.   "
74078|NCT02316132|"     After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's     esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is     needed for CLE but is not part of the investigation.      Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed     baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal     mucosa.      Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according     to randomisation) will be injected intravenously. Endoscopist and assistant staff will be     blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5     min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of     fluorescein into the gut lumen and widening of intervillous space.      Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin     catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to     visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast     cell tryptase to identify mast cell activation and numbers.      The procedure will take around 15 minutes in addition to the routine investigation performed     prior to the study. A study outline is presented in figure 1.      Samples taken are the same amount as done in the previous food associated study.   "
74087|NCT02316015|"     The aim of this study is to investigate if a standardized nutritional intervention with a     protein and energy enriched milk could help overcome the catabolic state in children     hospitalized with a bronchiolitis and thus creating a better nutritional state during     hospitalization and at outpatient follow-up.      The investigators also want to assess the clinical repercussion on the number of     hospitalization days, the duration of oxygen support and the quality of life at ouptatient     follow-up.   "
74088|NCT02316002|"     The main purpose of this study is to see how well the experimental drug pembrolizumab     (MK-3475) works in people with oligometastatic NSCLC who have already had treatment for their     disease. All patients will receive 200 mg of pembrolizumab intravenously on Day 1 of each     21-day cycle. Patients will receive the study drug for up to 8 cycles, and then if their     disease is doing well and the study doctor thinks they will benefit patients may receive     pembrolizumab for up to 8 more cycles.   "
74079|NCT02316119|"     Background: About 5% of patients with acute coronary syndrome (ACS) have had previously     ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population,     with a high incidence of ischemic events, and also of bleeding events. While the high     ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk     factors, their predisposition to bleeding events is not well understood. Hypothesis: The     increased bleeding risk in ACS patients with history of cerebrovascular event may be     justified by a low platelet activity. Methods: Unicentric, prospective, case-control study,     which included approximately 100 post-ACS patients with history of IS/TIA previously to the     acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The groups     were matched for gender, age, and ACS type and year of occurrence. All patients were taking     aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous     hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. Main     analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®, VerifyNow     P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry with ADP (LTA     ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL transport and     inflammatory evaliation   "
74080|NCT02316106|"     The purpose of this study is to evaluate three daratumumab dose schedules in participants     with Smoldering Multiple Myeloma.   "
74081|NCT02316093|"     Obesity may affect periodontal health by inducing gingival oxidative damage through increased     production in circulating reactive oxygen species (ROS). Several studies have demonstrated     that 8-OHdG in bodily fluids can act as a biomarker of oxidative DNA damage in periodontal     diseases and for evaluating the effect of periodontal treatment. In the present study we     hypothesized that high ROS levels in circulation may increase oxidative stress levels in the     gingival crevicular fluid (GCF) and saliva in obese patients with periodontal disease, thus     periodontal therapy could have positive effects on ROS levels.   "
74082|NCT02316080|"     The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching     agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with     desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with     7,5% of Biosilicate micro-particles (D2); Odontis RX® dentifrice (D3); Sorriso® dentifrice     (D4); Biosilicate micro-particles paste, 1:1 (D5), Desensebilize Nano P (D6), bioglass type     45S5 paste, 1:1 (D7); GC= distilled water, in the experimental groups: T1/D1; T1/D2; T1/D3;     T1/D4; T1/D5; T1/D6; T1/D7; T1/GC e T2/D1; T2/D2; T2/D3; T2/D4; T2/D5; T2/D6; T2/D7; T2/GC.     In the in vitro study, microhardness and roughness measurements, and images using scanning     electron microscopy (SEM) will be made on samples of bovine dental enamel and dentin     (4x4x3mm; n=10 per group) before and after the treatment with the bleaching gels (T1= 14     days/ 04 hours/day; T2=single session) and the desensitizers/remineralizer agents. In the     clinical study, the volunteers (n=10 per group) will be evaluated regarding dentin     hypersensitivity (DH), using visual analogue scale, before the beginning of the treatments     (T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days) in which the     desensitizers/remineralizer agents (there´s no control group in the clinical experiments)     will be applying. Data will be analysed intra and inter-group, statistically.   "
74083|NCT02316067|"     The purpose of this study was to evaluate the effects of an exercise program proposed by the     CHORDATA® Method on the functionality, maximal isometric torque, muscle activity and muscle     thickness of trunk muscles in patients with traumatic spinal cord injury.      The hypothesis is that the CHORDATA® Method could reduce the deleterious effects of the     traumatic spinal cord injury.   "
74084|NCT02316054|"     Long-term additive prognostic value of heterogeneity myocardial perfusion imaging of SPECT     over clinical and ischemia in high-risk diabetic patients   "
74085|NCT02316041|"     This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for     refractive correction of hyperopia using the small incision lenticule extraction (ReLEx     smile) method.      In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive     lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK     flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed     to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is     dissected and removed through a small 2-3mm incision without the need to create a whole flap.      The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize the     lenticule geometry iii) to assess the safety, efficacy and stability of the treatment   "
74195|NCT02314611|"     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to     evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing     components marketed in the European Union (EU). These types of studies are required by     regulatory authorities for all THA and resurfacing devices that do not have medium to     long-term clinical evidence available at the time of gaining approval to market in the EU.     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2     rev 2.   "
74086|NCT02316028|"     Despite the advances in the medical treatment of unresectable liver metastases from     colorectal cancer there is currently no curative treatment option available for these     patients. Decitabine is a cytidine analog with proven anti-neoplastic activity in patients     with acute myeloid leukemia and myelodysplastic syndromes. Decitabine causes demethylation of     the DNA strands of replicating cells. Hereby decitabine treatment demethylates the promoter     regions of tumor suppressor- and cancer testis antigen encoding genes leading to expression     of these genes by the cancer cells. The hepatic arterial route for administration of     cytotoxic drugs has been widely explored in treatment of colorectal cancer liver metastases     because these metastases depend for their blood flow from this artery (as opposed to the     normal liver tissue that is mainly dependent from the portal vein). By investigating the     administration of decitabine by hepatic arterial infusion the investigators intend to explore     the potential advantage of minimizing the systemic exposure (and toxicity) and maximizing the     concentration of decitabine within the liver metastasis. The primary objective of this phase     I will be to establish the recommended dose for decitabine by HAI for further use in phase II     trials. The most important secondary objective will be to document the effect of decitabine     by HAI on the expression of cancer testis antigens by the colorectal cancer cells, serving as     a reference for potential further exploration of decitabine by HAI in combination with cancer     immunotherapy   "
74089|NCT02315989|"     The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries'     proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung     Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on     tumors, as well as to assess the operating functionality of the proton therapy system.   "
74090|NCT02315976|"     This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of     chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg)     . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. The     study will include three visits the patient to the study center: Pretreatment / Assessment 1,     Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of treatment. At     each visit, data will be collected on the medical history, physical examination and vital     signs, and evaluation of episodes of angina pectoris, as well as the laboratory evaluation of     adverse events and the use of concomitant medications.   "
74091|NCT02315963|"     High motivation is a predictor for good therapy results in physical therapy [Grahn 2000]. The     investigator want to show that it is possible to increase patients motivation for stroke     rehabilitation by providing them objective performance feedback about the patients therapy     progress.   "
74092|NCT02315950|"     With the goal of providing improved treatment to patients with overactive bladder symptoms     (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI     combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum     toxin on bladder physiology. The investigators will specifically aim to assess the     physiological mechanism by which intravesical botulinum alleviates urgency and urge     incontinence symptoms in women with OAB refractory to medical therapy.   "
74093|NCT02315937|"     Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side     effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This     hypotension is often treated with fluid infusion. However, especially in elderly patients,     high volume fluid infusion can lead to fluid overload.      The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known.     Hence, therapy for hypotension after spinal anesthesia might not be adequate. With     transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used to     monitor fluid responsiveness and guide fluid management.      Objective: This study has two main objectives. The first is to explore the effects of spinal     anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter     and collapsibility. The second goal is to test the interrater variability transthoracic     echocardiography exams when performed by (trained) anesthesiologists.      Furthermore, the correlation between vena cava inferior collapsibility and the occurence and     degree of hypotension (defined as a decrease from baseline of >20% or a systolic pressure <     90 mmHg) after spinal anesthesia will be explored.   "
74094|NCT02315924|"     Intracranial atherosclerosis is common vascular lesion in Asian acute stroke patients and     intracranial atherosclerosis patients have high rate of coronary artery disease (CAD).     Moreover, several studies showed obvious association of CAD and cerebrovascular stenosis,     which had been proved to increase the risk of stroke after coronary revascularization     including coronary bypass surgery or percutaneous coronary intervention. In addition, the     efficacy and safety of combined coronary and cerebral intervention are not fully     investigated. Hence, the aim of this study is to evaluate the prevalence and characteristics     of coronary and cerebrovascular arteriosclerosis as measured by combined coronary and     cerebral angiography, explore the relationship between inflammation, atherosclerosis-related     markers and coronary and cerebral atherosclerosis and compare the efficacy and safety of     simultaneous or staged coronary and cerebral interventional strategy in Chinese Patients.      The coronary angiography and cerebrovascular angiography are performed for all participants.     The combined strategy for coronary and cerebrovascular angiography is carried out routinely     in the investigators institutions. Simultaneous strategy is considered as that performed via     the same access and within the same day. Staged strategy is intended as that performed within     7 days from the first procedure. The sequence of angiographies is established on an     individual patient basis by the cardiovascular and neurointerventional team according to     clinical symptoms of the patients and after coronary or cerebrovascular angiography. After     combined coronary and cerebral angiography, simultaneous or staged interventional strategy     will be performed in patients with severe coronary and cerebral stenosis. Blood sample is     obtained from artery sheath when performing coronary or cerebral angiography. Lipid levels,     inflammation and atherosclerosis-related markers will be measured in this study.   "
74095|NCT02315911|"     Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA.     Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE     or APP. Pediatric age span of 2 until 4,9 years.   "
74096|NCT02315898|"     Plastic bronchitis (PB) is a rare, most often pediatric disease characterized by the     formation of obstructive airway casts primarily composed of fibrin. There is presently no     FDA-approved pharmacotherapy for PB, but acute exacerbations of the illness are often treated     with inhaled tissue plasminogen activator (tPA). To date, this is done somewhat anecdotally     because there has been no safety or efficacy testing of this treatment. In addition, there is     presently no reliable surrogate marker of adverse drug events. Nevertheless, in the absence     of inhaled tPA treatment, PB-induced respiratory distress can be severe, often warranting     urgent or emergent bronchoscopy for cast removal, or can sometimes result in respiratory     failure. As such there is a significant unmet need for safety and efficacy testing of inhaled     tPA and for biomarkers of drug response.      Objectives and Endpoints: The objectives of this protocol are to: 1) test the safety and     efficacy of an inhaled tPA regimen in children with PB; and 2) identify potential candidate     biomarkers of inhaled tPA drug response. Safety endpoints will consist of the development of     new, active bleeding that is systemic and/or pulmonary and/or new hematuria (defined as gross     hematuria or 2+ microscopic hematuria). Secondary endpoints of efficacy will also be measured     (e.g., frequency of cast production). Urine and blood will also be collected for the     development of potential biomarkers of inhaled tPA drug response.      Funding source- FDA OOPD   "
74097|NCT02315885|"     The purpose of the research study of the K23 award is to develop a blood test that can check     how much alcohol a person has consumed in the past few days. We will enroll heavy social     drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a     single occasion. Both men and women between ages 21 and 65 years can join the study. All     participants must be of European decent.   "
74098|NCT02315872|"     This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are     experiencing chronic fatigue.   "
74112|NCT02315690|"     This is a cluster randomised controlled trial comparing the impact of two community based     malaria interventions: reactive case detection (RACD) vs reactive targeted presumptive     treatment (focal mass drug administration, fMDA) on the incidence of malaria in Swaziland.   "
75480|NCT02297828|"     The purpose of this study is to determine if the application of Boussignac continuous     positive airway pressure (CPAP) immediately after extubation improves PaO2 and PaO2/FiO2     ratio in morbidly obese patients undergoing gastric bypass surgery .   "
74099|NCT02315859|"     It is known that, at the end of the cardiac ejection period, potential energy is stored in     elastic fibers of the heart, which promotes the suction of blood from the atria during early     filling. The investigators have developed a new ultrasound-based method to quantify this     suction effect. Here, it is necessary to reduce the complex 3-dimensional cardiac mechanics     in a 1-dimensional (piston-like) pump system. In the study, several steps of model reduction     will be tested. Each reduction is intended to allow non-invasive measurements to become     increasingly simple and feasible at reduced echo quality. The reference method is the     invasive data obtained from a pressure-volume conductance catheter. To increase the supply of     potential energy in the elastic fibers, a substance (dobutamine) is administered for     transient strengthening of the force of contraction.      Hypothesis: There is a good agreement between the new, non-invasive parameters and the     invasive reference method for the quantification of the suction effect of the left ventricle,     and the good correlation persists even with increasing model simplification.   "
74100|NCT02315846|"     The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The     investigators therefore score patients once preoperatively and twice postoperatively with the     german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare     the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the     serum anticholinergic activity (SAA) at corresponding time points.   "
74101|NCT02315833|"     The purpose of this study is to validate the novel hypothesis that daily use of L-cysteine     (Acetium® capsules) is an effective means to decrease the frequency of (or completely abort)     the headache attacks in migraine patients.   "
74102|NCT02315820|"     The equipoise whether to Induce pregnant women with suspected large for gestational babies or     suspected macrosomia babies at term pregnancy is not solved yet. Only 2 relatively small     studies were conducted to answer this clinically important question.      The investigators will conduct a randomized controlled, multi-center study large enough to     confirm or refute our assumption that induction of labor at term reduces the shoulder     dystocia prevalence significantly compared to expectant management.   "
74103|NCT02315807|"     Transcranial direct current stimulation has shown promising results in stroke patients. This     study is a double blind, sham-controlled clinical trial aiming to compare the long-term     effects of stimulation in two different cognitive regions after a stroke. Sixty patients who     suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal     cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive     transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2     weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test,     categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey     Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline,     after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve     clinical improvement with neurostimulation will be invited to receive treatment for 12 months     as part of a follow-up study.   "
74104|NCT02315794|"     Different studies have proposed the use of zirconia abutments to improve the aesthetic     outcomes in the anterior sextant, however the results have been inconclusive. A tendency     towards a better aesthetic result with the use of zirconia instead of titanium abutments was     observed, although more technical complications were also recorded.The use of zirconia     abutments in the anterior maxillary region showed a tendency towards better matching,     although differences were not significant. In addition, with these abutments more technical     complications were observed, what increased the cost and time. More studies with larger     samples and longer observations periods are needed to recommend the use of zirconia abutments     for this clinical situation   "
74105|NCT02315781|"     Parkinson's disease (PD) is a progressive neurological disease that has effects on both     movement and mental health. One of the most common mental health complications of PD is     depression. Up to 30% of Parkinson's patients will experience depression at some point. We     aim to investigate whether transcranial direct current stimulation (tDCS), a type of     electrical stimulation for the brain, can improve depression in PD as well as improve motor     function in PD.   "
74106|NCT02315768|"     The purpose of the study is to determine whether ibrutinib in combination with GA101 -     Obinutuzumab might be useful for the treatment of CLL. This study will evaluate if ibrutinib     in combination with GA101 - Obinutuzumab can reduce the amount of cancerous cells in body.   "
74107|NCT02315755|"     Metastatic renal cell carcinoma (mRCC) is the most common malignant tumour of the kidneys.     Targeted therapies, which were recently introduced in the treatment of mRCC, have become the     standard treatment in these patients. With improved survival rate and a tolerable side effect     profile, Tyrosine Kinase Inhibitors (TKIs) have largely replaced conventional immunotherapies     worldwide.      In Turkey, due to reimbursement conditions, cytokine (interferon alpha) treatment is the     standard treatment as first-line therapy.      Therefore, the data on quality of life (QoL) from the pivotal studies with standard TKI     treatment does not reflect the QoL status of patients treated with TKIs as second or third     line treatment in Turkey. In this study, the clinical outcomes and the impact on quality of     life of targeted treatments following TKIs will be explored. To our knowledge, since there is     no similar reimbursement condition in the world placing IFN as the first line standard     treatment, this will be the first study evaluating the QoL status with targeted therapies     used as 3rd line treatment in mRCC patients.   "
74108|NCT02315742|"     The purpose of this study is to see if walking is effective for improving memory,     concentration thinking abilities, physical function and quality of life of adults 50 years of     age and older living with HIV.   "
74110|NCT02315716|"     The Cardamon trial is a phase 2 trial using the standard chemotherapy drugs cyclophosphamide     and dexamethasone in combination with a new drug called Carfilzomib in patients with multiple     myeloma.   "
74111|NCT02315703|"     The purpose of this study is to assess the safety and tolerability of various regimens     containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV),     Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug     product (gp140 DP) components and to compare envelope binding antibody responses between the     different vaccine regimens.   "
74131|NCT02315443|"     The purpose of this study is to determine whether NA-1 is effective in reducing global     disability in patients with acute cerebral ischemia if administered early after symptom     onset.   "
74113|NCT02315677|"     The purpose of this study is to determine the degree of epistaxis following nasal intubation     with either a nasal endotracheal (RAE) tube with bevel facing left or Parker Flex-Tip     endotracheal tube with bevel facing posteriorly      The investigators hypothesize that a Parker Flex-Tip endotracheal tube when inserted with     bevel facing posteriorly during nasal intubation may reduce the incidence of epistaxis intra     and post-operatively. The investigators propose that using this style of endotracheal tube     improves patient safety and comfort and facilitates ease and success of nasal intubation.   "
74114|NCT02315664|"     Physical activity is an essential first-line treatment for patients with knee osteoarthritis     (OA). However, a 2013 systematic review found only 13% met the activity recommendation of 150     minutes or more per week. The primary goal of this randomized controlled trail is to assess     the efficacy of a physical activity counseling model, involving a group education session,     the use of Fitbit Flex (a wireless physical activity tracking device), and online/telephone     coaching by a physiotherapist (PT), to improve physical activity and reduce sedentary time in     patients with knee OA. Engaging in regular physical activity can have the additional benefit     of improving cognitive functioning.   "
74115|NCT02315651|"     The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10     (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded,     placebo-controlled prospective study. All eligible patients will undergo randomization and     divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power     calculation, total of 60 subjects are expected to participate in the study. After the     screening of eligibility (up to 14 days), the study is divided into three phases:     pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of treatment,     and post-treatment phase. Screening: each participant will undergo screening for protocol     eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the inclusion     criteria and signed an approved informed consent (both parents and the child) will be     enrolled.   "
74116|NCT02315638|"     This is a long-term safety follow-up protocol for subjects who received TT-034 under the     B2801001 protocol and consists of monitoring for at least 4.5 years.   "
74121|NCT02315573|"     This study is focused on comparing patients' pain scores on a visual analogue scale (VAS) and     the difference in analgesics use post-operatively (with the same prescription defining only     the maximum frequency) between lidocaine with epinephrine & bupivacaine with epinephrine as     local anesthetics in wide-awake hand surgery. The investigators' hypothesis states that a     longer acting local anesthetic agent (bupivacaine) would be able to provide better     postoperative pain relief demonstrated by lower pain scores on VAS and less analgesics use     (as will be recorded on the patient's log). This will be mainly obvious in the first 24 hours     postoperative period when the pain is usually at maximum levels and starts to decline     thereafter. If the investigators' hypothesis is true, this may potentially change practices     of many hand surgeons towards the routine use of longer acting local anesthetics particularly     in wide-awake hand surgery, and perhaps could be extrapolated to other surgical specialties.     Further, a reduction in postoperative analgesics use would be of paramount clinical     importance, as it would reduce their potential side effects.   "
74122|NCT02315560|"     To determine the effects of electrical stimulation of the nerves in the foot on the incidence     of nocturnal enuresis (bedwetting) in children   "
74117|NCT02315625|"     Background:      - Neuroendocrine tumors (NETs) come from cells of the hormonal and nervous systems. Some     people have surgery to shrink the tumor. Sometimes the tumors come back. Researchers think     that treatment with drugs based on knowing the defective gene might give better results.      Objective:      - To see if drugs selected based on the defective gene result in better tumor response. The     drugs are sunitinib and everolimus.      Eligibility:      - People age 18 and older with an advanced low- or intermediate-grade gastrointestinal or     pancreatic neuroendocrine tumor.      Design:      - Participants will be screened with:      <TAB>- Medical history      <TAB>- Physical exam      <TAB>- Scans      <TAB>- Blood, urine, and lab tests        -  The study team will see if participants should have surgery.        -  If yes, participants will:        -  Sign a separate consent        -  Have CT scan before and after surgery        -  Have as much of the tumor removed as possible. A small piece will be tested for mutation          type.        -  If no, participants will have a small piece of tumor removed for the testing.        -  If the surgery might cure them, the participant will leave the study. The other          participants will be assigned to take either sunitinib or everolimus.        -  Participants will take their drug by mouth once a day. They will keep a medicine diary.          Some will keep track of their blood pressure at least weekly.        -  Screening tests may be repeated at study visits. Participants also may have their heart          evaluated.        -  About 30 days after the last day of their study drug, participants will have a follow-up          visit that repeats the screening tests.        -  Participants will be contacted every 3 months after this visit.   "
74118|NCT02315612|"     Background:      - One type of cancer therapy takes blood cells from a person, changes them in a lab, then     gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a     virus, and an immune receptor to change the cells.      Objective:      - To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with     certain cancers is safe and effective.      Eligibility:      - People ages 1-30 with a leukemia or lymphoma that has not been cured by standard therapy.      Design:        -  Participants will be screened to ensure their cancer cells express the CD22 protein.          They will also have medical history, physical exam, blood and urine tests, heart tests,          scans, and x-rays. They may give spinal fluid or have bone marrow tests.        -  Participants may have eye and neurologic exams.        -  Participants will get a central venous catheter or a catheter in a large vein.        -  Participants will have white blood cells removed. Blood is removed through a needle in          an arm. White blood cells are removed. The rest of the blood is returned by needle in          the other arm.        -  The cells will be changed in a laboratory.        -  Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the          hospital for this.        -  All participants will be in the hospital to get anti-CD22 CAR cells through IV. They          will stay until any bad side effects are gone.        -  Participants will have many blood tests. They may repeat some screening exams.        -  Participants will have monthly visits for 2-3 months, then every 3-6 months. They may          repeat some screening exams.        -  Participants will have follow-up for 15 years.   "
74119|NCT02315599|"     Background:      - Gene therapy involves changing the genes inside the body s cells to stop disease. It is     very closely regulated. People who have had this therapy may have problems months or even     years later. Researchers do not know the long-term side effects, so they want to study people     who have had the therapy. They want the study to continue over the next 15 years.      Objective:      - To study over time the negative side effects from genetically engineered cellular therapy.     This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy     trials.      Eligibility:      - People who are currently or were previously in a research study with gene therapy in the     National Cancer Institute POB.      Design:        -  Participants blood will be tested right before they get the genetically changed cells.          They will get the cells as part of another study.        -  For the next year, they will come back to the clinic or see their doctor at home at          least every 3 months. They will answer questions about their health and blood will be          drawn.        -  For the next 5 years, they will go to the clinic or see their own doctor once a year.          They will have physical exam and blood will be drawn.        -  For 10 years after that, they will be asked every year for health information.        -  Participants will keep their contact information up to date with researchers. They may          be phoned for more health information.        -  If the participant was under 18 years old when given the gene therapy and turns 18          during this follow-up, they will be asked to sign a new consent form when they turn 18.   "
74120|NCT02315586|"     Background:      - Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that becomes worse over time.     There is currently no effective treatment for it. Researchers want to study the disease and     learn new ways to treat it.      Objectives:      - To discover new pathways that are involved in pulmonary fibrosis. To develop new drugs that     may be used to treat pulmonary fibrosis.      Eligibility:        -  People at least 18 years old with IPF.        -  Healthy volunteers at least 18 years old.      Design:        -  Participants will be screened with medical history, questionnaire, and physical exam.          They will have blood, lung, and walking tests and chest scans.        -  All participants will have 1 study visit, including:        -  Medical history and physical exam.        -  Questions about their breathing.        -  Blood tests.        -  Breathing tests.        -  Six-minute walk test.        -  Pregnancy test.        -  Chest x-ray (healthy volunteers) or chest CT scan (people with pulmonary fibrosis ).        -  Small area of skin may be removed.        -  Genetic tests of blood and skin samples. Participants will probably not be informed of          any findings. Samples may be used to make stem cells for use in research. Participants          may be contacted in the future to give consent for this research.        -  Some participants will have repeat visits over many years, repeating many of the study          tests.   "
74146|NCT02315248|"     The purpose of this study is to validate a human saliva sample analyzer technique designed to     screen for low bone density and osteoporosis. The analyzer technique is meant to be a simple,     noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using     a point-of-care device that monitors salivary markers of bone turnover in a screening patient     population that is at risk for low bone density or osteoporosis.   "
74147|NCT02315235|"     To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy     in patients with diabetic painful neuropathy.   "
74123|NCT02315547|"     Study 1 is a cross-sectional investigation. Patients with clinically stable bronchiectasis     (symptoms, including cough frequency, sputum volume and purulence, within normal daily     variations) will undergo baseline assessment consisting of history taking, routine sputum     culture, 16srRNA pyrosequencing, measurement of sputum inflammatory markers, oxidative stress     biomarkers and MMPs, and spirometry. Microbiota taxa will be compared between bronchiectasis     patients and healthy subjects.      In study 2, patients inform investigators upon symptom deterioration. Following diagnosis of     BEs, patients will undergo the aforementioned assessments as soon as possible. This entails     antibiotic treatment, with slightly modified protocol, based on British Thoracic Society     guidelines [16]. At 1 week after completion of 14-day antibiotic therapy, patients will     undergo convalescence visit.      Study 3 is a prospective 1-year follow-up scheme in which patients participated in telephone     or hospital visits every 3 months. For individual visit, spirometry and sputum culture will     be performed, and BEs will be meticulously captured from clinical charts and history inquiry,     with the final decisions adjudicated following group discussion.   "
74124|NCT02315534|"     This is an open label, multi-center, phase 1 safety run-in and phase 2 study of BBI608 in     combination with temozolomide in patients with recurrent or progressive glioblastoma who have     not received prior bevacizumab therapy.   "
74125|NCT02315521|"     The investigators propose a standardized prenatal management, based on the scientific     evidence published in the literature, to manage prenatally fetuses with lower urinary tract     obstruction (LUTO). The present study is a prospective registry that will evaluate and     validate this standardized prenatal management for LUTO.   "
74126|NCT02315508|"     This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the     treatment of tinnitus.   "
74127|NCT02315495|"     The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without     acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin,     C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the     effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in     patients with type 2 diabetes.   "
74128|NCT02315482|"     The purpose of this study is to assess the different effects of pneumoperitoneum and steep     trendelenburg position on autonomic nervous system modulation during laparoscopic     prostatectomy   "
74129|NCT02315469|"     This research trial studies comprehensive patient questionnaires in predicting complications     in older patients with gynecologic cancer undergoing surgery. Comprehensive patient     questionnaires completed before surgery may help identify complications, such as the need for     assistance in taking medications, decreased mobility, decreased social activity, and falls,     and may improve outcomes for older patients with gynecologic cancer.   "
74130|NCT02315456|"     The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of     centration of the capsulorhexis- scanned capsule centration and pupil centration. It is     hypothesized that scanned capsule centration provides more uniform(25% better) overlap of     capsulorhexis margin over IOL optic compared to pupil centration.   "
74134|NCT02315404|"     Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat     because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is     a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis     and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is     unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to     limited visualization of the small bowel lining during conventional endoscopy. One way to     improve visualization of the small bowel lining is by adding a transparent plastic cap to the     end of the endoscope (camera), which allows the endoscope to see around sharp turned and     behind folds in the small bowel.      The investigators goal in this randomized controlled study is to see if adding a transparent     cap to the end of the endoscope will help to identify and treat small bowel bleeding. The     investigators will invite patients referred for BAE to participate in the study; the     alternative to participating in the study is having standard BAE (without a cap). If patients     choose to participate in the study they will be randomized to BAE with or without a cap on     the end of the endoscope. Subjects time commitment will be limited to the consent process and     pre-procedure paperwork at time of initial endoscopy and time required to complete telephone     questionnaire at 12 months follow up.   "
74135|NCT02315391|"     The primary objective is to determine the effect of reduced activity on the stimulation of     myofibrillar FSR with protein feeding in the elderly.   "
74148|NCT02315222|"     Patient with periodontal disease undergoing full mouth disinfection will be given dietary     supplements or placebo and reevaluated after 3 months.   "
74149|NCT02315209|"     Outpatient services in Germany are less controlled by external quality assurance programs.     Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g.     for day case surgery. A quality-of-life instrument specific to hernia repair with mesh has     been recently proposed (Carolinas Comfort Scale, CCS) .This study evaluates the integration     of CSS as part of a multicentre quality assurance scheme for day-case (outpatient)     surgery.b.The Study Group on Quality assurance in ambulatory hernia surgery has developed     and standardized Operation technique for 3D Implants. As a consequence, any deviation must be     documented by the standard. The extension to other centers according to a standardized     protocol took place (shadowing to learn the operational standards, training in documentation,     Minimum quantity 30 interventions per year, etc.).   "
74136|NCT02315378|"     This study is a randomized controlled trial to investigate the feasibility and effectiveness     of a brief Anxiety Reduction Treatment for Acute Trauma (ARTAT) with adults (over age 18)     showing signs of peritraumatic anxiety in the Emergency Department of Bellevue Hospital, New     York in the hours following a psychologically traumatic event. Thirty-six participants will     be enrolled over a 12-month period: 18 receiving ARTAT and 18 receiving Treatment As Usual     (TAU). The study will target anxious arousal in patients immediately (1 to 8 hours) following     a trauma. Participants will be recruited from among patients who present in the Emergency     Department at Bellevue Hospital for treatment of an injury sustained in a traumatic event     (accident, assault) as long as injuries do not preclude participation. Participants included     in the study will have experienced a trauma within 8 hours and presenting with signs of a     strong risk factor for PTSD: peritraumatic panic (severe psychological and physiological     anxiety symptoms such as fear of dying, fear of losing emotional control, tachycardia,     sweating, shaking and dissociation symptoms such as derealisation and depersonalization that     occur during and immediately following a trauma. Following the initial assessment, eligible     participants will be randomized to receive the one-hour anxiety-reduction intervention     designed to reduce anxiety and panic symptoms through education and anxiety y management     skills or TAU. The clinician administered and self-report assessments will be conducted at     screening, baseline, post-treatment, weekly, and at a one-month and three-month follow-up.   "
74137|NCT02315365|"     This real-life Health Economics and Outcome Research (HEOR) study will enable to assess the     impact of current therapies on quality of life (QoL), productivity loss and health care     resource utilization in metastatic breast cancer (mBC). This prospective study will estimate     patient-reported outcomes (PROs) and resource utilization data for mBC patients stratified     according to treatment type, treatment line and disease status (progression vs. progression     free) in a real-life setting.      To estimate QoL, work productivity and health care resource utilization of post-menopausal     patients with ER+/HER2- locally advanced or metastatic breast cancer in a real-life setting.     The secondary objective is to estimate QoL and work productivity of mBC patients' caregivers.      During the course of the study, data will be collected on quality of life and work     productivity. Patients and caregivers will be asked to fill a set of questionnaires at their     recruitment in the study, at 3 months and at 6 months after recruitment.   "
74138|NCT02315352|"     The primary objective of the trial is to compare the overall palatability of the new orally     disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and the     current available racemate PZQ tablets (reference) as assessed by means of human gustatory     sensation tests (100 millimeter [mm] visual analogue scale [VAS] scoring modified by the     incorporation of a 5 point facial hedonic scale).      The secondary objectives are        -  To obtain feedback from children regarding the taste of different formulations using an          open ended questionnaire        -  To document any discomfort or other observation in relation to acceptance of the study          medication   "
74177|NCT02314845|"     The purpose of this randomized single center study is to determine the individual PEEP value     that produces the best possible compromise of lung collapse and lung hyperdistention.     Patients submitted to general anesthesia and mechanical ventilation during surgery     (laparoscopy and open surgery) will participate. A PEEP titration procedure will be performed     and the optimal PEEP value will be determined by electrical impedance tomography (EIT). An     ultrasound will be used to record each step of the PEEP titration procedure in a sub-sample     of patients. A total of 40 patients will be mechanically ventilated using physiological tidal     volume (TV=6mL/kg of IBW) and fraction of inspired oxygen (FIO2) of 0.5 and will be     randomized to one of two groups: optimal PEEP or a low PEEP (4cmH2O). Lung collapse and     mechanics will be monitored by EIT throughout the intraoperative period. After extubation, a     lung CT will be performed to evaluate the amount of lung collapse.   "
76158|NCT02288975|"     The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48     hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as     monitored by leukocyte activation and inflammatory mediators.   "
74139|NCT02315339|"     The European Home Mechanical Ventilation Registry (EHMVR) will enable a thorough evaluation     of HMV by documenting the characteristics of HMV patients and their treatment. This will     facilitate a prospective, observational study to identify the primary indications for HMV,     describe patterns of HMV use in European countries, and characterize changes in the     initiation and utilization of HMV over time. The registry will target all adult individuals     who have an indication for HMV. In the EHMVR, patient data from routine clinical care will be     documented using an electronic case report form (eCRF). The eCRF will record: patient     demographic data; diagnostic information (including primary diagnosis, 6-minute walk time,     the presence of depression, and quality of life); blood gases; ventilation treatment     (including type of ventilator, modes and settings, interfaces used); follow-up data     (including failure rates, side effects, technical issues). An initial Pilot Phase will be     launched with the aim to enrol at least 200 patients over a 6-month period to determine the     feasibility of the registry. Steering committee members and their institutions will be the     main participants in the Pilot Phase. After completion of the Pilot Phase, the registry will     be expanded across Europe with the goal of enrolling approximately 10,000 patients over 5     years.   "
74140|NCT02315326|"     The purpose of this study is to test any good or bad effects of the study drug called of     ibrutinib (also known as Imbruvica™) at 840mg daily dosing has on the patient and the     lymphoma in the central nervous system.   "
74141|NCT02315313|"     It is a retrospective study with no products limitation to investigate the link between     clinical resting HR and SOA. Use HR≤60bpm as control group, compare other three groups with     the control group and find out the correlation between HR and SOA indexes.   "
74142|NCT02315300|"     Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD)     exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD).     Hypoglycemia is a frequent problem in insulin-treated patients, especially in those with CKD,     and various studies have shown that hypoglycemic episodes are strong predictors of     cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and     small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about     the direct association of hypoglycemic events and/or rapid swings in blood glucose with     arrhythmias in this high risk population. Ideally, an algorithm should help to identify     patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic     analyses of blood glucose values and 12-channel ECGs are lacking in these patients.   "
74143|NCT02315287|"     Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option     in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed     thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.   "
74144|NCT02315274|"     Hypothesis:      Increased contact with the diabetes care team throughout pregnancy will lead to improved     glucose control during pregnancy.   "
74145|NCT02315261|"     This study aims to evaluate the effectiveness of the epidural analgesia in patients having     elective thoracic and abdominal surgery under general anesthesia combined with epidural     analgesia in Siriraj Hospital.   "
74174|NCT02314884|"     A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability,     Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients     With Advanced Solid Tumors   "
74150|NCT02315196|"     This phase II trial studies how well pegylated liposomal doxorubicin hydrochloride and     carboplatin followed by surgery and paclitaxel work in treating patients with stage II-III     breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts     of human epidermal growth factor receptor 2 (HER2)/neu protein (triple negative). Drugs used     in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, carboplatin, and     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving pegylated     liposomal doxorubicin hydrochloride and carboplatin before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed. Giving pegylated liposomal     doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel may be an     effective treatment for breast cancer.   "
74151|NCT02315183|"     Acute kidney injury (AKI) complicates over 25% of cardiac surgical procedures where it     increases mortality up to fourfold. The incidence of AKI is increasing, the pathogenesis is     poorly understood, current diagnostic tests lack specificity and sensitivity, and there is no     effective treatment. Improving outcomes in patients at risk of AKI has recently been defined     as an NHS priority. The primary aim of this study is to determine how plasma derived     microvesicles (MV) or more specifically MV associated microRNAs (miRNA) regulate survival and     signalling in post cardiac surgery AKI. The study involves a clinical and experimental     research project that will combine laboratory analyses of circulating MV and miRNA from     clinical studies. The study will specifically consider how MV and miRNA alter inflammatory     signaling in kidneys after cardiac surgery, how these are modified by important clinical risk     factors, and whether they may serve as early biomarkers of injury.   "
74152|NCT02315170|"     To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during     and after intravitreal injections.   "
74153|NCT02315157|"     This phase I trial studies the side effects and best dose of bendamustine hydrochloride in     treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such     as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading.   "
74154|NCT02315144|"     The primary objective of the study is to characterize the safety profile and duration of     bronchodilation of a single dose of inhaled TV48108.   "
74155|NCT02315131|"     The primary objective of the study is to characterize the safety profile and duration of     bronchodilation of a single dose of inhaled TV46017   "
74178|NCT02314832|"     Blocking sensation from the femoral nerve by injecting local anesthetic around the nerve     plays an important role in pain control after total knee replacement. However, femoral nerve     block has been associated with increased risk of falls due to weakness of the thigh muscle.     This prospective, randomized controlled trial asks the question whether blocking the more     distal branch of the femoral nerve (saphenous nerve) will result in less muscle motor block,     and thus less risk of falls. The study also aims to compare pain control after both     techniques.   "
74156|NCT02315118|"     Despite advancement in chemotherapy, radiotherapy and haematopoietic stem cell transplant     (HSCT), and the recent introduction of more targeted therapies, a substantial proportion of     patients with B-cell malignancies, such as B-cell chronic lymphocytic leukemia (CLL) and     B-cell non-Hodgkin's lymphoma (NHL) still succumb to their malignancies. For CLL and     low-grade NHL, cure is achievable only with HSCT but such aggressive approach is not     justified as the initial therapy for most patients who have indolent disease; when disease     has progressed, transplant is either not feasible or ineffective. For high-grade B-cell NHL,     the availability of Rituximab has improved disease outcome but treatment failure portends     nearly inevitable death from disease or treatment-related complications. Thus, newer, more     effective therapies for patients with B-cell malignancies are urgently needed.      The present study translates recent laboratory findings into clinical application. In     patients with B-cell malignancies receiving the anti-CD20 antibody Rituximab as standard     therapy, the study aims to assess the feasibility and safety, as well as explore the     efficacy, of infusing autologous T-lymphocytes engineered to express a CD16-41BB-CD3zeta     chimeric receptor which mediates antibody-dependent cell cytotoxicity. Receptor expression is     achieved by electroporation of mRNA.   "
74157|NCT02315105|"     The purpose of this study is to find out more about the safety and effectiveness of the     Laparoscopic Greater Curvature Plication (LGCP) procedure in patients with obesity and     related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep     apnea, and joint problems. LGCP is a less invasive weight loss surgery procedure than some of     the other weight loss surgeries and it is possible that there are fewer risks with this     procedure than with the other weight loss surgeries. LGCP is considered an experimental     procedure and this study is being done to look at the long-term outcomes.   "
74158|NCT02315092|"     The current trial aims to compare the assessment of diabetic foot ulcers by fluorescence     image guidance to standard practice. The device will be used to acquire fluorescence images     of diabetic foot ulcers: when wounds are illuminated by violet/blue light, most pathogenic     bacterial species emit a unique red fluorescence signal. The device is intended to be used as     part of the clinical assessment process, which may include visual assessment, signs of heat     or high temperature, the presence of exudate, and redness in the area. Images will guide the     clinician to inspect, sample or further evaluate areas where fluorescing bacteria is present.     This study will allow us to determine the benefit of fluorescence image-guided procedure as     compared to standard clinical practice to assess bacterial burden in diabetic foot ulcers.     Microbiological swabbing under standard practice and fluoresce-guided imaging will be     performed in order to compare the two techniques.   "
74159|NCT02315079|"     To evaluate the use of a point of care device to measure markers of inflammation in various     eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is     an enzyme that plays a role in inflammation. The value obtained with the point of care device     will be correlated with values obtained using gel electrophoresis to measure MMP-9 from the     same sample. These data will be compared to clinical exam findings and questionnaires to help     the investigators better understand the role of this marker of inflammation in eye diseases     and possibly improve diagnostic abilities.   "
74160|NCT02315066|"     To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in     combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in     order to determine the maximum tolerated dose and select the recommended Phase 2 dose.   "
74161|NCT02315053|"     A prospective observational study to determine the prognostic value of the timing of 50%     reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).   "
75833|NCT02293226|"     The investigators will compare the success rates and time to successful intubation of     endotracheal intubation during simulated pediatric and infant resuscitation with and without     chest compression using four different video-laryngoscopes.   "
74162|NCT02315040|"     Overall Study Design and Plan Description        -  The study will be conducted on women with fertility difficulties who are designated for          intrauterine insemination treatment (IUI). The research sample size is 137 treatment          cycles per group (total of 274 treatment cycles). The women will be randomly divided          into two groups. Some will undergo the standard bolus IUI treatment and others will be          treated with the EVIE Slow Release Insemination method (SRI). Women who fail to conceive          in the first treatment will next receive the alternative treatment. This means that a          woman treated with the IUI method who does not become pregnant will then be treated with          SRI, and vice versa (crossover method). The study will include women treated with          Clomiphene Citrate or with other Gonadotropin-based treatment. Every couple treated will          undergo at least 2 insemination cycles (unless pregnancy has already been achieved).        -  Before beginning the hormone treatment, each couple will have the trial procedure          explained to them. This explanation will include all the detailed information and          instruction about the IUI and the Slow Release Insemination methods. A Patient          Information Sheet will be available to them.        -  Preparation of the spermatozoa for intra uterine insemination will be identical to the          method performed currently before IUI.      Approximately two weeks after the insemination treatment, a blood sample will be taken from     the woman to check for Beta hCG levels to indicate pregnancy.      Hypothesis:      SRI leads to higher pregnancy rates compared to standard IUI      Primary endpoint:      • Pregnancy rate Effect of controlled Intra-uterine slow release insemination on the     pregnancy rate of women designated for intra uterine insemination in comparison to the     accepted IUI method.   "
74163|NCT02315027|"     The purpose of this study is to determine whether mesenchymal stem cells (MSCs) can be safely     delivered to the cerebrospinal fluid (CSF) of patients with multiple system atrophy (MSA).     Funding Source - FDA OOPD.   "
74164|NCT02315014|"     To determine whether a balanced total daily dietary protein distribution supplemented with     whey protein during a weight-loss intervention will result in increased muscle protein     synthesis   "
74165|NCT02315001|"     A single-centre double-blind placebo-controlled crossover randomised controlled trial to     determine the physiological basis of glucagon-like peptide-1 receptor activation on exercise     haemodynamics, as manifest through specific electrophysiological parameters measured by     serial exercise stress testing, in those patients with reversible myocardial ischaemia and     obstructive coronary artery disease confirmed by a baseline exercise test and coronary     angiography respectively.   "
74179|NCT02314819|"     Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on     and one week off) was well tolerated and demonstrated encouraging preliminary clinical     antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase     2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the     treatment of patients with metastatic CRC who have progressed after second line or above     standard chemotherapy   "
85423|NCT02167932|"     This study will look at whether or not participating in a physical activity intervention     during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a     large increase after chemotherapy.   "
74166|NCT02314988|"     This study is designed to evaluate the efficacy of topical tranexamic acid to reduce     perioperative blood loss, reduction in postoperative drain output and allogenic transfusion     requirements.      The proposed study will be a prospective, randomized, double-blind (subject, surgeons,     investigators, research coordinators) placebo-controlled study. Patients following high     energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or     ligamentous injury with resultant instability requiring posterior spinal fusion will be     enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery     will also be enrolled. Both populations of patients will be randomized into two groups. Group     I will receive standard of care operative fixation with topical tranexamic acid intervention     (test); Group II will receive standard of care operative fixation with normal saline     (placebo) intervention. This study will have a 2-year follow-up and will consist of three     periods: screening/enrollment phase up to 21 days from the day of injury to the day of     randomization and operative intervention, an inpatient data collection period for 4 days     postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2     week, 16 week, 1 year, and 2 year) time points.   "
74167|NCT02314975|"     The aim of this study is to compare the clinical efficiency of conventional fixed appliance     orthodontic treatment with that supplemented by the daily application of cyclic forces to the     dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is     rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort     during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root     length.   "
74168|NCT02314962|"     Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT     and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR     perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly     prognostic.   "
74169|NCT02314949|"     An immunomodulatory protocol, experimentally-proven to promote T-regulatory dependent graft     protective mechanisms was applied in a clinical cohort of 13 intestinal transplant recipients     to activate - in a protolerogenic environment - T-regulatory cells.      This protocol is the standard of care in the investigators intestinal transplant programme     since the first intestinal transplant was performed in october 2000.   "
74170|NCT02314936|"     This study will investigate the effectiveness of Polydextrose, a dietary fiber, at increasing     Colonic Transit Time and decreasing the gastrointestinal symptoms of Functional Constipation.     One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive     8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter     will receive a placebo daily.   "
74171|NCT02314923|"     Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has     affected several thousand people. There is no approved effective way to treat or prevent     Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola     vaccine BPSC-1001 to see if it is safe and to see how it affects people's immune system.   "
74172|NCT02314910|"     If implants are osseointegrated, there might be innervation of the bone close to the     implants. This event might explain the so-called osseoperception phenomena: Functioning with     implant-supported oral prostheses is better than with removable prostheses due to physiologic     integration and thus sensory feedback.   "
74173|NCT02314897|"     Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves     placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex.     It is now known that tricuspid regurgitation (TR) frequently results from this and may lead     to increased morbidity or mortality. Recently, left ventricular (LV) pacing through an     epicardial vein via the coronary sinus has been widely practiced due to the advent of     biventricular pacing. This lead does not cross the TV, potentially reducing the risk of TV     dysfunction and may also reduce the risk of LV dysfunction. The investigators hypothesize     that LV pacing will prevent the onset of new TR or worsening of pre-existing TR in patients     undergoing pacemaker implantation.      Methods Patients receiving a pacemaker for sick sinus syndrome (n=20) with an LV ejection     fraction <40% will be randomly allocated to receive either conventional RV pacing or LV     pacing via the coronary sinus. Serial 2D and 3D transthoracic echocardiography will be     performed before implantation, one day post implantation, then at 1 week, 1 month, 6 months     and 1 year. The primary endpoints will be new onset TR and the diagnosis of at least moderate     TR. Other endpoints include biventricular function, ventricular dyssynchrony, complications     of device implantation, mortality and major cardiovascular events.   "
74176|NCT02314858|"     Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious     medical condition with significant medical and psychological consequences, including     diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is     Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway     creating a pneumatic splint to keep the airway open during sleep. Adherence to PAP is     notoriously low, with as few as 50% reaching minimal guidelines for adherence. One     comprehensive review of adherence research found that adherence to PAP was less than that for     any other medical disorder. The problem of adherence is significant not only because of the     medical consequences that can ensue, but also because third party payers have begun to refuse     to pay for PAP therapy when adherence is less than optimal, even in the face of clinical     improvement. This is a critical time to address this problem.      This research study is designed to identify methods that may help people respond to PAP, the     most common therapy for OSA. Identifying these methods may be an important way to better care     for patients with obstructive sleep apnea. With this research, the investigators hope to find     ways to help people have a better response to treatment and a better quality of life.   "
74180|NCT02314806|"     The patients undergoing axillary lymph node dissection were randomized into 3 groups:     patients undergoing lavages with normal saline (Group 1), patients undergoing lavage     gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution     (Group 3). Drainage volume discharge is investigated   "
74181|NCT02314793|"     The purpose of this study is to evaluate the safety and tolerability of single ascending oral     doses of ASP2205 in healthy young male and female subjects. This study will also evaluate the     safety and tolerability of multiple ascending oral doses of ASP2205 in healthy young and     elderly female subjects.   "
74182|NCT02314780|"     Ischemia reperfusion injury may be attenuated by HO-1 induction. Our previous data confirmed     strong HO-1 induction in peripheral blood cells following heme arginate infusion in healthy     humans5. Furthermore, we could demonstrate the amelioration of experimental ischemia     reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured     by functional MRI6.      Therefore, we propose that HO-1 induction in the human heart may be a suitable target to     mitigate cardiac ischemia-reperfusion injury.      The HO-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and     after aortic cross clamping in subjects with or without preceding heme arginate treatment in     two different dosages. The HO-1 expression will also be measured in the clinical trials in     peripheral blood mononuclear cells. As additional outcome, levels of myoglobin,     creatine-kinase and troponin T and reactive oxygen species will be measured in plasma     according to standard laboratory procedures.   "
74183|NCT02314767|"     Lohja Depression Treatment Study is a randomized treatment trial which compares three     approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2)     Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims to     test and adapt known short term treatment models for Finnish patients and circumstances.   "
74184|NCT02314754|"     To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48     hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77     days' compared to women 64-70 days' LMP.   "
74185|NCT02314741|"     The investigators wish to monitor the adoption of a new, incisionless approach to performing     a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic     Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally     providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The     investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet     inclusion criteria.      The POEM procedure has been done in many hospitals without any research associated with it.     Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being     trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has     performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first     case to be proctored by an experienced operator. The PI will then proctor the other adopters.     The investigators would like to evaluate the safety of it and the effectiveness of it. The     investigators will use their symptom scores and radiology tests pre- and post-POEM to     evaluate effectiveness.   "
74196|NCT02314598|"     This is a prospective, non-randomized, multicenter, post market release study which will     collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the     high voltage portion of the defibrillator lead and will evaluate the electrogram signals.   "
74186|NCT02314728|"     Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the     vaginal canal before the onset of labor. The integrity of the amniotic membrane is     compromised thereby increasing the risk of intrauterine infection and compression of the     umbilical cord. PROM complicates 3% to 8% of pregnancies in the US and is responsible for 30%     of preterm births. Intrauterine infection remains the most significant maternal and neonatal     sequelae associated with PROM and this risk increases with the length of time from ruptured     membrane to delivery. Induction of labor has been shown to reduce the rates of     chorioamnionitis, endometritis and NICU admissions4. Specifically, induction of labor with     prostaglandin agents followed by oxytocin, versus oxytocin alone has been shown to be     effective for labor induction resulting in vaginal delivery. Management strategies for PROM     have been controversial, and published studies on outcomes are over one to two decades old,     which does not account for changes in clinical trends and practice patterns. Recently ACOG     recommends that patients presenting at 37 weeks gestation or greater with PROM should be     induced if not in labor, and generally with oxytocin. In women with PROM without the onset     of labor, the cervix is commonly unfavorable and induction with oxytocin alone may lead to an     increased risk of cesarean section. With a c-section rate as high as 33%, women undergoing     induction of labor have an increased risk of c-section and its associated morbidity and long     term sequela. ACOG's recommendation for the use of oxytocin as the induction agent may be     meant to avoid a theoretical increased risk of chorioamnionitis in this patient population     however it does not take into account the status of the cervix, which may result in a     increased risk of c-section. The purpose of the proposed study is to determine whether     cervical ripening in women with PROM and an unfavorable cervix is associated with increase     rates of vaginal delivery and decreased cesarean section rate compared to induction of labor     with oxytocin alone. The investigators aim to determine the incidence of endometritis, and     neonatal infection associated with PROM in the current medical environment of antibiotic     prophylaxis and antenatal steroid use, taking into account the changes in patient     characteristics.   "
74187|NCT02314715|"     Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA)     the most common form. The lifetime risk of developing symptomatic KOA by the age of 85 years     is 44.7%, where females are at a greater risk (1.8 times) than male counter parts. KOA is the     leading cause of limitations in activities of daily living such as walking and climbing     stairs particularly in the elderly. This is primarily due to pain and instability of the     joint resulting in buckling of knees caused by muscle weakness, joint stiffness and damage.     Patients with KOA have larger variations in muscle strength and are unable to maintain a     target force combined with impaired ability to perceive joint movement and positioning     suggests impaired neuromuscular control (NC) may influence KOA. NC refers to the nervous     system's control over muscle activation contributing to task performance. This study aims to     establish the role of loss of NC in biomechanical determinants and health outcomes of KOA.   "
74188|NCT02314702|"     MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy     of its THA and resurfacing components marketed in the EU. These types of studies are required     by regulatory authorities for all THA and resurfacing devices that do not have medium to     long-term clinical evidence available at the time of gaining approval to market in the EU.     This study has been designed in accordance with MEDDEV 2.12/2 rev 2.   "
74189|NCT02314689|"     The purpose of this study is to assess the maximum tolerated dose, safety and     pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in     steady-state sickle cell disease.   "
74190|NCT02314676|"     This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin)     Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad     population of children. Half of participants will receive the high dose, while the other half     will receive the low dose.   "
74217|NCT02314325|"     This trial is designed to assess if there is evidence of subclinical joint bleeding on     MRI/X-Ray in adults with severe Haemophilia A while on standard and/or pharmacokinetically     tailored prophylaxis regimens. Participants with severe Haemophilia A will have longitudinal     MRI and XRay imaging of their elbows, ankles and knees at 0, 6 and 18 months while on     standard ( 0-6 months) and then pharmacokinetically tailored (7-18 months) recombinant Factor     VIII prophylaxis.   "
74191|NCT02314663|"     Background In subjects with hypercholesterolaemia, cholesterol values remain above guideline     levels. One of the limiting factors to the achievement of goals in such patients is     therapeutic non-adherence. The aim of this study is to assess the effectiveness of an     intervention designed to improve control of hypercholesterolaemic patients, consisting of a     combined strategy that would include the delivery of printed information,     treatment-compliance check cards and the dispatch of text messages as complementary measures     in support of the intervention at the general practitioner's practice.      Methods/Design A randomised, parallel-group clinical trial will be conducted at the family     medicine outpatient facilities of eight health centres in three of Spain's Autonomous     Regions, covering a total of 358 subjects aged 18 years or over with diagnosis of     hypercholesterolaemia. Patients in the intervention group will be supplied with printed     material with information on the disease and its management, mobile-telephone text messages     with guideline summaries, reminders of forthcoming appointments and/or arrangements for     making new appointments in the event of non-attendance, and self-report cards to check     compliance with recommendations. Both groups -intervention and control- will receive routine     recommendations from their physicians in accordance with current European clinical practice     guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the     measurements to be made, the main variable is the proportion of subjects who attain the low     density lipoprotein cholesterol levels set as a target across a follow-up period of 24     months. The secondary variables are as follows: adherence to recommendations on lifestyle and     adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels;     appearance of cardiovascular events; physical activity; food consumption; smoking habit;     anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents;     socio-demographic data; beliefs and expectations about preventive recommendations; and degree     of satisfaction with the combined strategy.      Discussion Should this intervention prove effective, a recommendation could be issued on the     application of this combined strategy to subjects with hypercholesterolaemia. It is a simple,     relatively inexpensive intervention.   "
74192|NCT02314650|"     The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during     general anesthesia could reduce the need for propofol in patients undergoing minor surgery.   "
74193|NCT02314637|"     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as     monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type     2 Diabetes for 52 weeks administration.   "
74194|NCT02314624|"     The ultimate goal is to facilitate the delivery of empirically supported treatments (ESTs)     for mental disorders and to improve client mental health outcomes. Toward this end, this     Phase II SBIR proposal seeks to complete the development and testing of PracticeGround, a     comprehensive software system designed to integrate with electronic health records, and that     contains multiple methods of training clinicians in ESTs and delivering ESTs to clients,     continuous progress monitoring of client outcomes, and clinical support tools to guide     clinicians and clients through delivery of the necessary EST. The investigators will conduct     an 18-week randomized controlled trial (N=80) comparing PracticeGround (n=40) to     care-as-usual (n=40) in depressed outpatient clients. PracticeGround clinicians will have     full access to the software. Study clinicians and clients will be assessed once every six     weeks (baseline, 6, 12, and 18 weeks). To ensure generalizability of findings, the     investigators will not control for natural therapy variations (e.g.,session frequency,     medication use, etc.). Primary outcomes include: depression, psychological distress,     treatment satisfaction (clients and clinicians), and treatment drop out. Secondary clinician     outcomes include: extent of PracticeGround use with clients across clinicians' caseload.   "
74197|NCT02314585|"     This study looks to see the effects of a home based exercise program on falls in people with     MS.   "
74198|NCT02314572|"     The objective of this study is to assess the visual outcome after the combined binocular     implantation of +2.5 D and +3.0 D apodized diffractive multifocal intraocular lenses.   "
74199|NCT02314559|"     Deep sedation with propofol for ambulatory colonoscopy has become standard clinical     practice.To achieve the necessary (e.g.: no excessive movement and no awareness) level of     sedation during colonoscopy, propofol can be titrated by hand, continuous infusion or by     target controlled infusion.      The aim of the investigators is to evaluate sedation efficacy and recovery between two groups     of ambulatory patients having a colonoscopy: one group will receive a manual titration of     propofol, the other group a target controlled infusion (TCI) of propofol. The investigators     will evaluate both groups before, during and after colonoscopy for adverse events, quality of     sedation and recovery. When patients are estimated to be ready for discharge, they will also     be subjected to a cognitive and a psychomotoricity test.   "
74200|NCT02314546|"     The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal     midazolam makes giving the midazolam easier and more comfortable without affecting how the     midazolam works as a sedative.   "
74201|NCT02314533|"     The investigators design this prospective, open-label, parallel, controlled study to     investigate fenofibrate's effect on microalbuminuria reduction and serum creatinine on top of     statin therapy in Chinese hypertriglyceridemic patients with type 2 diabetes.   "
74202|NCT02314520|"     The goal of this study is to determine whether Peripherally Inserted Central Catheter or     Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience     Intensive Care Unit. After admission to the Neuroscience ICU and if they require central     access, patients will be randomized to receive a PICC or CVC and complications (such as     pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between     the two interventions.   "
74203|NCT02314507|"     The purpose of the study is to investigate whether Gua sha is an effective modality for     relieving chronic low back pain specifically in the aged population by comparing the baseline     measures of pain intensity, self-perceived disability, back range of motion, back local     muscle stiffness, depression, sleeping quality, quality of life, biomarkers measurement, and     analgesic intake on days 1 and 7 after a single session of Gua sha treatment. In addition,     the investigators are going to compare between Gua sha and hot pack treatments for the above     parameters.   "
74218|NCT02314312|"     Single center, open-label randomized-control trial Population: de novo 48 kidney transplant     recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and     prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of     everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors     Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation   "
74219|NCT02314299|"     This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one     of the two treatment groups to determine the effects of topical ocular administration of low     dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and     Age-Related Macular Degeneration.   "
75800|NCT02293655|"     This study evaluates the effects of receiving and then discontinuing methylphenidate (MPH) in     children with ADHD. After receiving MPH for 8 weeks, participants will be randomized to     either discontinue MPH (and receive placebo) OR remain on MPH for 4 weeks.   "
74204|NCT02314494|"     Children who are above healthy weight are more likely to be ill and to miss time off school.     Being overweight in childhood can also sow the seeds for health problems in later life such     as heart disease and diabetes. Most overweight children become overweight adults. One     solution is to try to prevent children becoming overweight by intervening very early in life.     The risk factors for childhood overweight are known and this project aims to facilitate     parents' (and other carers') understanding about this for their infant and to enable them to     access intervention. UK health visitors (public health nurses) will use an interactive,     multimedia programme (Proactive Assessment of Overweight Risk during infancy (ProAsk)), with     parents to calculate their infant's risk and to discuss strategies for risk reduction as     appropriate. Health visitors will be trained to communicate obesity risk and in Motivational     Interviewing techniques to enable them to offer intervention to parents of infants identified     as at risk.      A feasibility study of ProAsk will take place in two health provider organisations in the UK.     The purpose of this is to a) determine the acceptability and utility of the ProAsk     intervention with health visitors and parents and b) gather information to inform the trial     design and data collection procedures for a future Randomised Controlled Trial (RCT).   "
74205|NCT02314481|"     DARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who     relapse with NSCLC (clinical trials.gov ref. NCT02183883),      The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal     actionable mutation) is associated with PFS.      Patients 1) without an actionable mutation and PDL1 positive or 2) without an actionable     mutation and PDL1 negative following first line cytotoxic chemotherapy, will receive     MPDL3280A a monoclonal antibody targeting anti-PDL1.      Patients with BRAFV600 mutations, Her2 Amplification, ALK/RET gene rearrangements will be     enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib     respectively.      DARWIN II will include extensive exploratory biomarker analysis to investigate a number of     genomic and immune markers that may predict response to MPDL3280A and help guide future     clinical trial design.   "
74206|NCT02314468|"     Introduction Necrotising soft tissue infections (NSTI) incorporate a spectrum of pathologies,     all characterized by an infectious state, typically arising after a penetrating trauma or a     surgical procedure and an expeditious spreading of necrosis throughout the soft tissues of     the body. It is a rare, life-threatening and devastating infection defined by a necrosis of     fascia, subcutaneous tissues and skin. Aggressive surgical debridement to remove all necrotic     tissue and define the extent of the disease is still the mainstay of correct treatment of     NSTI.      Both negative pressure wound therapy (NPWT) and the application of allograft skin to debrided     areas, are documented options for wound bed preparation which are standard in the university     hospital of Gent.      NPWT is a technique for wound bed preparation involving the controlled application of     sub-atmospheric pressure to the local wound environment, using a sealed wound dressing     connected to a vacuum pump. Mechanisms of action attributed to NPWT include an increase in     blood flow, promotion of angiogenesis, reduction in wound surface area, positive modulation     of the inhibitory contents of wound fluid, induction of cell proliferation, reduction of     edema, and bacterial clearance.      Allograft skin or cadaveric skin possesses many of the ideal properties of biologic     dressings, and plays a major role in the surgical management of extensive wounds when     autologous tissue may not be immediately available. It reduces evaporative water loss and the     drainage of protein-rich fluids, prevents wound desiccation, and suppresses microbial     proliferation. Wound pain is lessened and the allograft restores a physiologic barrier at the     wound surface. Enhancing revascularization, and thereby creating a viable wound bed before     final reconstruction, is perceived as one of the most important features of allografting.   "
74207|NCT02314455|"     To determine how the esophagus in active and inactive stages of eosinophilic esophagitis     tranmit fluids.   "
74208|NCT02314442|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.   "
74209|NCT02314429|"     In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases     lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy     volunteering women and left in place for 7 days. The primary objective of this phase I study     is to assess the safety and the tolerability of this new intravaginal delivery system.      The eventual goal of this and related studies is to develop a vaginal ring that reduces     recurrences in women suffering from bacterial vaginosis, which is the commonest form of     vaginal infection.   "
74210|NCT02314416|"     The purpose of the study is to use a collagen matrix embedded with amniotic stem cells to     speed up the maturation and integration of the collagen matrix in the wound bed and shorten     total time needed for wound healing.   "
74214|NCT02314364|"     This research study is studying a type of radiation therapy called Stereotactic Body     Radiation Therapy (SBRT) as a possible treatment for stage IV non-small cell lung cancer     (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) or or displaced anaplastic     lymphoma receptor tyrosine kinase (ALK) or ROS proto-oncogene 1 (ROS1) gene (=     oncogene-driven NSCLC) and for which the subject has been receiving treatment with a targeted     biological agent such as erlotinib, crizotinib, or other drugs.   "
74215|NCT02314351|"     Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous     metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However,     the role of metoclopramide was based on three randomized, placebo-controlled studies, which     were carried out with relatively few patients. Those trials suggested that metoclopramide     produced larger improvements in visual analog scale (VAS) scores, however they revealed     conflicting results and had significant methodological problems (risk of bias, allocation of     concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of     intravenous metoclopramide in acute migraine attacks comparing with placebo.   "
74216|NCT02314338|"     Patients with COPD often have limitations to physical performance. There are several tests     for evaluating physical performance, unfortunately many of them can be time consuming and     require specialized equipment an substantial space. Short physical performance battery is a     simple test that requires little resources and can be performed both at institutions and in     the homes of patients. SPPB has high predictive abilities in identifying older adults at     greater risk for mortality, nursing home admission, hospitalization, and incidence of     disability. The investigators would like to evaluate possible changes in the SPPB score after     a 4-week rehabilitation program. The investigators would also like to look at possible     relationships between the SPPB and other physical performance measures, dyspnea, anxiety,     depression, fatigue, and health related quality of life.   "
74323|NCT02312921|"     The main goal of the payment and delivery system reform is to reduce disparities in oral     health and dental care access of low-income mothers and children living in rural Oregon     counties. The target population is children, pregnant women and new mothers enrolled in     Oregon Health Plan (OHP) in rural Oregon.   "
74220|NCT02314286|"     Prospective randomized single blind trial. Study population are women diagnosed with severe     pre-eclampsia during singleton pregnancy, between 24+0 weeks and 41+6 weeks gestational age.     The purpose of the study is to evaluate the effect of Rosuvastatin on the severe preeclampsia     resolution at 48 hours after delivery. After screening and signing an informed consent form,     before entering delivery room, a randomization 1:1 will be carried. 50 women will be in the     treatment arm while 50 will be in the control arm. Both groups will be treated according to     ACOG (The American College of Obstetricians and Gynecologists has the following clinical     guidelines related to deliveries before 39 weeks) guidelines. In addition, following     randomization experimental group will be treated with Rosuvastatin 40mg that will be     administrated orally with or without food. Treatment will be carried within the first hour     following delivery. Another dose will be given 24 hours after first administration. Control     group will be treated with placebo.   "
74221|NCT02314273|"     The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may     increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who     develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine     arabinoside+mercaptopurine，7d） therapy.   "
74222|NCT02314260|"     To have an early more precise way to predict failed induction in patients undergoing elective     termination of pregnancy & those more likely to undergo caesarian section,this will Spare     patients with decreased chances of favorable induction a long and exhausting trial of labour     with increased probability of complications and an emergency caesarian   "
74223|NCT02314247|"     This is a single-arm, multi-center, open-label Phase II study of the SINE™ compound Selinexor     given orally to patients with relapsed/refractory PTCL and CTCL.      Approximately 60 patients with relapsed or refractory PTCL and CTCL who meet the eligibility     criteria and have none of the exclusion criteria will be enrolled to receive Selinexor until     either disease progression or intolerance has occurred.   "
74224|NCT02314234|"     To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block     by sugammadex during IONM of facial nerve during parotid surgery   "
74225|NCT02314221|"     The primary objective of this study is to achieve successful walking skills using exoskeletal     walking devices over the course of 36 sessions in 3 months at specific velocities and     distances in people with chronic SCI who are wheelchair dependent for community mobility. The     secondary objectives are to determine if this amount of exoskeletal walking is effective in     improving bowel function and body composition in the same patient population. The exploratory     objectives are to address additional questions concerning the retention or non-retention of     the positive changes, the effects of the increased physical activity from this intervention     on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels,     and quality of life (QOL).      A Phase III randomized clinical trial (RCT) will be performed using a crossover design and     employing an exoskeletal-assisted walking intervention. The experimental arm will be compared     to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (>6 month post     injury) who are wheelchair-dependent for outdoor mobility in the community. The WALK arm will     consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6     h/week) for 36 sessions for their second 12-week period. The UA arm will consist of     identification of usual activities for each participant, encouragement to continue with these     activities and attention by study team members throughout the 12-week UA arm. These     activities will be recorded in a weekly log. The investigators hypotheses are that 1) this     exoskeletal intervention will be successful in training ambulatory skills in this patient     population, 2) the exoskeletal intervention will be better than a control group in improving     body composition, bowel function, metabolic parameters and quality of life in the same     population.   "
74227|NCT02314195|"     Previous studies have highlighted the potential therapeutic benefits of receptive individual     music therapy as an adjunct to standard care, in a variety of psychiatric ailments including     mood and anxiety disorders. However, the role of music in the treatment of obsessive     compulsive disorder have not been investigated to date. The present study therefore aimed to     investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions     in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion     of patients with OCD have other comorbid mood or anxiety disorders, the question of whether     therapeutic benefits of music could be expanded to also affect concurrent depressive and     anxiety symptoms was explored.   "
74228|NCT02314182|"     A prospective, open, multicenter, randomized III trial with two arms:        -  Arm A: Primary tumor resection , followed by chemotherapy        -  Arm B: Chemotherapy alone. Compare overall 2-year survival rates in patients treated for          resectable rectal adenocarcinoma with unresectable metastasis, treated either with the          primary tumor resection with chemotherapy +/- target therapy, or with chemotherapy (+/-          target therapy) alone.   "
74229|NCT02314169|"     This phase II trial studies how well nivolumab works in treating patients with anal canal     cancer that has not responded to previous treatment (refractory) and has spread to other     places in the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor     growth in different ways by targeting certain cells.   "
74230|NCT02314156|"     This randomized trial studies transdermal or oral telapristone acetate in treating patients     undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent     breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally     may be safer and have fewer side effects than oral administration.   "
74231|NCT02314143|"     This is a three-arm, open-label, randomised Phase II study to evaluate whether the different     sequencing of dabrafenib and trametinib monotherapies and the upfront combination has an     impact on translational or clinical activity in subjects with BRAF mutant metastatic     unresectable stage IIIc or IV melanoma. Both dabrafenib and trametinib have demonstrated     clinical activity as monotherapies and in combination in BRAF-mutant melanoma. However,     duration of responses seem to be limited due to acquired drug resistance. The goal of this     protocol is to study the sequential effects of BRAF and MEK inhibition on skin, blood and     tumour biomarkers and to study the correlation between biomarkers and response to treatment     and intrapatient toxicity. Approximately 54 eligible subjects will be randomised in the ratio     of 1:1:1 to one of the three treatment arms.   "
74232|NCT02314130|"     The objective is to evaluate the effect of no-commercial enteral diet for patients in home     nutritional therapy in anthropometric and biochemical indices comparing to patients using     commercial enteral diets.   "
74233|NCT02314117|"     The main purpose of this study is to evaluate the effectiveness of ramucirumab, which is a     targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine     and cisplatin alone in participants with stomach cancer.   "
74324|NCT02312908|"     The purpose of this study is to determine whether clonazepam is effective and safe in the     treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease     (PD).   "
74234|NCT02314104|"     The purpose of this study is to determine if there is a better method of administering pain     medication prior to minimally invasive gynecological surgery so that postoperative pain     and/or narcotic usage may be minimized. Currently, no standard of care exists regarding the     use of local pain medications in minimally invasive gynecological surgery and practices vary     widely among physicians, even within the same institution.      The two methods of preemptive pain medication that this study will be looking at is the     transversus abdominis plane (TAP) block and the local injection of pain medication at the     areas of the skin incisions. TAP block is a procedure performed by a specially trained pain     management anesthesiologist in which there is an injection of a local pain medication into     the abdominal wall, specifically in a space where the nerves that are responsible for     postoperative pain reside. This procedure blocks the ability of the nerves to sense pain and     has been found to be successful in decreasing postoperative pain in a number of procedures.     The local injection of pain medications at the incision sites has also been found to be     beneficial in decreasing postoperative pain. However, it is not known whether one method is     superior to the other in decreasing postoperative pain or if the combination of both is best.      Patients that chose to participate are randomly (by chance) assigned to one of three groups:     1) TAP block with pain medication and local injection of normal saline (water) at the     incision sites 2) TAP block with normal saline and local injection of pain medication at the     incision sites or 3) TAP block with pain medication and local injection of pain medication at     the port sites. These procedures are performed while the patient is asleep. Patients will be     asked to record their level of pain on a standardized pain scale at one hour, six hours, and     twenty-four hours after the surgery. All patients are provided with standard postoperative     pain medications as needed.      The hypothesis is that patients receiving both TAP block and local injection of pain     medication at the port sites will have less pain postoperatively and require a smaller amount     of narcotics than those that receive either the TAP block or local injection of pain     medication alone.   "
74235|NCT02314091|"     Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional     hernia   "
74236|NCT02314078|"     A decision-to-delivery interval of 30 minutes for category-1 Caesarean section deliveries is     the standard of practice recommended by clinical guidelines.   "
74237|NCT02314065|"     Background      Severe health anxiety is a highly distressing, often debilitating, psychological problem.     Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its     clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD)     or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several     treatments for severe health anxiety have shown great promise, the most well-established     being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other     psychotherapies - has typically been delivered face-to-face. That is, the patient physically     meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT     does not rest on this requirement, but has nevertheless been shown to be efficacious for     severe health anxiety (see for example NCT01673035).      Aim of the study      The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face     for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is     applied to determine if Internet-delivered CBT is at least as efficacious as its     well-established predecessor.   "
74238|NCT02314052|"     The purpose of this study is to assess the safety and tolerability of the investigational     anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid     particle suspension that targets the oncogene MYC. MYC oncogene activation is important to     the growth of many hematologic and solid tumor malignancies. In this study the Sponsor     proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell     growth.   "
74263|NCT02313714|"     This study intends to treat patient with congestive heart failure that are maximized their     pharmacological treatment and at heart transplant wait list.      All patients in the treatment arm will receive electric muscular stimulation with a Russian     current protocol twice a week for 7 weeks.      The outcome will be assessed by the improvement in quality of life and functional capacity.   "
74239|NCT02314039|"     This cross sectional questionnaire based study will aim at exploring psychological factors at     play in the experience of acne, and their association with perceived and clinical severity.     We will focus in particular on the role of psychological trauma in the patients with acne and     their wellness. This project is being undertaken as part of a wider developing initiative in     the Dermatology Department within NHS Tayside, which aims at identifying and consequently     addressing the psychological needs of their patients. Participants will be consecutive     patients with acne aged at least 18 years old, seen in the outpatient clinics of the     Dermatology Department in NHS Tayside. Potential participants will be informed about the     research by their clinician during an outpatients appointment and if interested, given an     information sheet and consent form to review. Verbal consent will be sought by the clinician     to give the potential participant's contact details to the Chief Investigator (CI)/Research     Assistant (RA). If agreeable, the CI/RA will contact the potential participant after at least     24 hours to arrange a mutually agreed time for meeting. If the potential participant are     still keen to participate and has read the information sheet, fit our inclusion criteria, are     not deemed to be distressed by their attending clinician and want to take part, they will be     included. Participants will complete a number of standardised questionnaires and a     demographics information sheet in the outpatients' clinic with the CI/RA present. The     questionnaires include questions on psychological trauma history and symptomatology, general     psychological distress, appearance related distress and perceived severity of condition.     Clinical severity of their acne will be obtained from patient files after questionnaire     completion by NHS staff. Participants will also be given a debrief letter and additional     forms of support and information to take home with them. Participants will not be contacted     for follow-up.   "
74240|NCT02314026|"     This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without     the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological     findings associated with of Non-Alcoholic Steatohepatitis (NASH) and other liver diseases     using the BreathID® System   "
74241|NCT02314013|"     The aim of the present study was to evaluate whether antibiotics is mandatory for the     treatment of acute uncomplicated right-sided diverticulitis.      The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided     colon will be recovered without antibiotics.   "
74242|NCT02314000|"     To demonstrate sustained clinically significant pain relief in patients with chronic pain     when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at     sub‐perception amplitude   "
74243|NCT02313987|"     The current study is designed to test the hypothesis that compared to conventional treatment;     endothelial function-guided treatment reduces adverse cardiovascular events in patients with     non-obstructive coronary artery disease documented at clinically indicated coronary     angiography.   "
74244|NCT02313974|"     At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been     determined.      Almost 30 percent of patients in total remission during or after a treatment, will relapse in     the first 5 years.      The factors associated to Renal relapses are not completly known. The investigators think     that an histological control study performed to patient with complete remission for a year at     the end of a 3 years treatment could help us to know which patients are going to relapse.   "
74245|NCT02313961|"     The primary objective of the RIC-STEMI trial is to assess whether remote ischaemic     conditioning (RIC) as an adjunctive therapy during primary percutaneous coronary intervention     (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) can improve     clinical outcomes as assessed by death from cardiac-cause or hospitalization for heart     failure (HF) for a minimum follow-up period of 12 months.   "
75801|NCT02293642|"     Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its     validity and responsiveness.   "
74246|NCT02313935|"     The study involved Information and Communication Technologies (ICT) and more specifically     computer exercises blended with game activities. It was hypothesized that ICT facilitated,     game blended cognitive and/or physical exercise improves global cognition when compared to     control groups; moreover, these improvements may be manifested by brain activity changes; we     explored the impact of potential moderators on combined exercise-induced cognitive benefits,     as well as, individual/separate training schemes.   "
74247|NCT02313922|"     The purpose of this study is to evaluate whether etanercept combined with methotrexate are     superiority than etanercept as monotherapy in the treatment of chinese severe plaque     psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was     conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by     PASI (psoriasis area and severity index) response or PASI75 (a patient that has an     improvement from baseline PASI of at least 75%)   "
74248|NCT02313909|"     This is a study in patients who recently had a brain attack (stroke) and in whom no clear     cause of the stroke could be identified. These strokes are likely due to a blood clot and     therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The     study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban     15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have     fewer blood clots in the brain (stroke) or in other blood vessels.   "
74249|NCT02313896|"     This is a 2 year research study to study if post discharge phone calls can help lengthen time     to hospital readmissions for patients with encephalopathy.   "
74250|NCT02313883|"     A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel     Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and     Root Planing in Subjects with Periodontitis   "
74251|NCT02313870|"     This controlled multi-center randomized clinical trial, with direct individual benefit, will     compare efficacy and safety of two strategies in non-localized BP care: a combined regimen     using initial superpotent topical steroids associated with methotrexate for 4 weeks followed     by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months     (current standard of care). The expected result is an equivalence between the two compared     strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase     being easier to manage and therefore associated with better compliance than topical steroids     with less cutaneous side effects and most cost-effective.   "
74264|NCT02313701|"     The investigators aim is to augment the current process for surgical consent for patients     undergoing urogynecological procedures by incorporating visual media. We propose that visual     media will be an effective and efficient addition to the standard of care in urogynecological     consents and will improve patient understanding and satisfaction. Our randomized controlled     trial will investigate the effect of standardizing the consent for three urogynecologic     procedures (vaginal hysterectomy, robotic sacrocolpopexy, and sub-urethral sling) using     visual media, on patients' understanding of, and satisfaction with, their procedure. Our     primary outcome will be patient's knowledge score at the end of the pre-operative clinic     visit, and secondary outcomes include patients' satisfaction, subjective understanding of     their procedure, immediate pre-operative and post-operative knowledge, and number of     post-operative encounters. Participants will be followed up to their post-operative clinic     visit.   "
74252|NCT02313857|"     Patients enrolled on this study will have received a stem cell transplant. After a     transplant, while the immune system grows back the patient is at risk for infection. Some     viruses can stay in the body for life, and if the immune system is weakened (like after a     transplant), they can cause life-threatening infections.      CMV can cause serious infections in patients with weak or suppressed immune systems. It     usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut,     the liver and the eyes.      Investigators want to see if they can use a kind of white blood cell called T cells to treat     CMV infections that occur after a transplant. Investigators have observed in other studies     that treatment with specially trained T cells has been successful when the cells are made     from the transplant donor. However as it takes 1-2 months to make the cells, that approach is     not practical when a patient already has an infection.      Investigators have now generated CMV-specific T cells from the blood of healthy donors and     created a bank of these cells. Investigators have previously successfully used frozen     virus-specific T cell lines generated from healthy donors to treat virus infections after     bone marrow transplant, and have now improved the production method and customized the bank     of lines to specifically and exclusively target CMV.      In this study, investigators want to find out if the banked CMV-specific T cells derived from     healthy donors are safe and can help to treat CMV infection.      The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food     and Drug Administration (FDA).   "
74253|NCT02313844|"     Patients enrolled on this study will have received a stem cell transplant. After a     transplant, while the immune system grows back the patient is at risk for infection. Some     viruses can stay in the body for life, and if the immune system is weakened (like after a     transplant), they can cause life-threatening infections.      BK virus (BKV) is a virus that can cause serious life-threatening infections in patients who     have weak immune systems. It affects the urinary tract, and can cause frequent urination,     blood in the urine, and severe pain.      Investigators want to see if they can use a kind of white blood cell called T cells to treat     BKV infections that occur after a transplant. Investigators have observed in other studies     that treatment with specially trained T cells has been successful when the cells are made     from the transplant donor. However as it takes 1-2 months to make the cells, that approach is     not practical when a patient already has an infection.      Investigators have now generated BKV-specific T cells from the blood of healthy donors and     created a bank of these cells. Investigators have previously successfully used frozen     virus-specific T cell lines generated from healthy donors to treat virus infections after     bone marrow transplant, and have now improved the production method and customized the bank     of lines to specifically and exclusively target BKV.      In this study, investigators want to find out if the banked BKV-specific T cells derived from     healthy donors are safe and can help to treat BK virus infection.      The BKV-specific T cells (Viralym-B) are an investigational product not approved by the Food     and Drug Administration (FDA).   "
74254|NCT02313831|"     The purpose of this study is to investigate the effects of interval training, based-intensity     on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic     threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic     profile in patients with and without coronary artery disease.   "
74255|NCT02313818|"     The primary goal of this study is to improve the overall efficacy of cognitive processing     therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through     a variable length treatment.   "
74256|NCT02313805|"     Diabetes prevalence continues to rise worldwide, leading to the increasing use of insulin.     This especially applies to developing countries where the needle-and-syringe method of     administration remains the most affordable and effective form of hyperglycemic treatment.     Competent health care professionals are required to ensure safe insulin initiation. The     investigators will evaluate a teaching intervention on insulin initiation for medical     students, and whether after experiencing that intervention the use of a checklist, during     simulate insulin initiation, improves the education they provide to patients.   "
74257|NCT02313792|"     The purpose of this study is to compare the efficacy and safety of palifermin on reducing     mucositis for patients receiving autologous or allogeneic stem cell transplantation with     supportive care.   "
74258|NCT02313779|"     The overarching goal of the proposed research is to investigate the role of emotions in     facilitating successful lifestyle change, defined as healthy behavioral decisions repeated     daily, or near daily.      Participants are asked to make two lab visits during the course of four weeks to complete     electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate,     blood pressure, respiration), and listen to a guided meditation audio track. Additionally,     between the two visits participants will be asked to complete weekly surveys that ask about     daily meditation practice (outside of the lab) and general emotions.   "
74259|NCT02313766|"     Adults patients scheduled for elective surgery were randomly allocated to receive     preoxygenation with spontaneous breathing, positive pressure ventilation (positive     inspiratory pressure: 12 cmH2O) without PEEP, and with PEEP (positive inspiratory pressure:     12 cmH2O, PEEP: 6 cmH2O). Preoxygenation time was measured from face mask positioning to     FEO2=90% (FEO2 : expired fraction of O2). After endotracheal tube placement the time until     SpO2=93% (SpO2 : peripheral oxygen saturation) was measured during monitored apnoea.     Patient's discomfort was recorded (visual analogue scale).   "
74260|NCT02313753|"     The purpose of this study is to evaluate the utility of the Coping Long Term with Active     Suicide Program (CLASP) for reducing suicidal behavior.   "
74261|NCT02313740|"     Prospective cohort study to evaluate safety and immunogenicity of the fragmented, inactivated     trivalent Influenza vaccine produced at Butantan Institute in healthy adults and elderly. The     study will include a total of 120 participants: 60 participants aged 18 to 59 years in the     healthy adults group, and 60 participants aged older than 60 years in the elderly group.This     study will evaluate the safety of one dose of the fragmented, inactivated trivalent Influenza     vaccine in the first 3 days after vaccination, as well as its immunogenicity 21 days after     vaccination.   "
74262|NCT02313727|"     It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for     pamidronate) study. All patients with AS will receive treatment with TNF inhibitor, while     randomization will be performed for pamidronate versus placebo group. Primary outcome will be     the rate of radiographic progression of AS, calculated after 24 months of combined treatment.   "
74265|NCT02313688|"     The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly     during the past decades. By the Siewert classification, the AEJ is the tumor center located 5     cm above the anatomic cardia and 5 cm below it, which is divided into three individual     subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ.     The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal     approach gastrectomy has better survival outcomes compared with left thoracoabdominal     approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is     recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines of     the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal resection     margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is still     controversies. Previous study found that longer than 2cm proximal resection margin had better     survival outcome than less than 2cm proximal resection margin for Siewert-II/III tumors. On     the other sides, due to more advanced tumor stage of patients in China when compared with     Japan and Korea. It is necessary to conduct a randomized control study to analyze the length     of resection margin in advanced adenocarcinomas of esophagogastric junction.      Therefore, this study was aimed to include those Siewert II/III tumor patients in     Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the     relationship between the length of proximal resection margin and survival outcomes.   "
74266|NCT02313675|"     The purpose of this study is to determine the efficacy of intra-operative administration of     IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and     distal radius fracture patients.   "
74267|NCT02313662|"     All patients planned for PDD guided TURB can be included in this study. Two different optics     with PDD and NBI are applied to the resectoscope in addition to regular WL.      First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then     NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with     registration of any additional findings. To adjust for bias introduced by photo bleaching,     the second part of the study will be performed with PDD as the second modality. Any flat     lesions will be biopsied if they appear suspicious in one of the modalities.      The registration form is completed by the surgeon, once the pathology results are known.      A total number of 152 patients is planned to be included.   "
74268|NCT02313649|"     This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography     (SWE) correspond with a biopsy result (currently the gold standard). The population that will     be evaluated are Chinese patients infected with the Hepatitis B virus.   "
74325|NCT02312895|"     This is a comparative study to determine if there is a difference in pain reduction and     disability between dry needling and manual therapy for patients with low back pain. Subjects     will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling     or manual mobilizations along with patient education and a home exercise program.   "
74269|NCT02313636|"     Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of     the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy     and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light     sources.      First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After     WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical     decision is noted.      A total number of 896 patients is planned to be included.   "
74270|NCT02313623|"     The investigators hypothesize that this single-cell analysis can be used to evaluate prostate     needle-core biopsies prospectively even in non-homogenous samples by providing profiles of     proteomic and phenotypic signatures. These profiles will in turn enable better predictions of     the malignant progression of prostate cancers in the settings of current clinical practice.   "
74271|NCT02313610|"     The purpose of this study is to assess the efficacy and safety of Chinese medicine Qinbudan     in Patients Receiving Standard Combination Therapy for Retreatment Pulmonary Tuberculosis.   "
74272|NCT02313597|"     Anal fistula is the most common Peri anal disease. It's a disease with an incidence of 9 in     100,000. Anal fistula is classified on the basis of its location into high and low anal     fistula, above or below dentate line respectively.      Multiple series have shown that the formation of a fistula tract following anorectal abscess     occurs in 7-40% of cases. There are typically 8-10 anal crypt glands at the level of the     dentate line in the anal canal arranged circumstantially. These glands afford a path for     infecting organisms to reach the intramuscular spaces. The cryptoglandular hypothesis states     that an infection begins in the anal canal glands and progresses into the muscular wall of     the anal sphincters to cause an anorectal abscess.      According to internal opening many author proposed certain classification but the     standardized in all of them is Park's classification, so this study categorized the patient     through this classification. There are four types of fistula-in-ano in Park's Classification     intersphincteric (between internal and external sphincters is 70%), transsphincteric (across     external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above     and through levator ani).High anal fistula is considered to be difficult to treat because of     its location.This study diagnosed the internal opening of high perianal with the help of     endoluminal ultrasound and MRI.      Classic method of its treatment are fistulotomy, fistulectomy and Setone placement but these     are associated with lots of complication like fecal incontinence,recurrence,pain.Therefore     many method have been recently devised including Ligation of intersphincteric fistula tract     (Lift), glue repair and flap advancement.Another recently introduced method for its treatment     is Video-assisted anal fistula treatment (VAAFT) proposed by P. Meinero which has been     associated with less complications.   "
74273|NCT02313584|"     The purpose of this study is to investigate the appropriate duration of dabigatran use after     radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low     thromboembolic risk. According to the most recent guideline, anticoagulation is recommended     to continue at least 2 months after the procedure. However bleeding risk with anticoagulant     is also problematic. Post-procedural thrombosis is considered due to acute inflammation or     char formation at the site of ablation, and these reaction occurs mostly within 1 month after     the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score     less than 1. The investigators hypothesized that dabigatran use for the first 1 month after     the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for     efficacy and safety compared to conventional dabigatran use for 2 months.   "
74274|NCT02313571|"     The computer-integrated patient controlled epidural analgesia (CIPCEA) system can     automatically adjust the background infusion rate during combined spinal-epidural (CSE)     analgesia based on the parturient's need as labour progresses. Analysis of parturients     experiencing breakthrough pain may identify associated factors that can also be related to     obstetric or foetal outcomes   "
74275|NCT02313558|"     The objective of the present study was to compare the anti-plaque and anti-gingivitis effects     of a commercially available dentifrice containing 0.6% Ilicis Rotundae Cortex extract to     those of a control dentifrice without any active ingredient in 12 weeks of home use.   "
76662|NCT02282488|"     A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low     protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as     reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.   "
74276|NCT02313545|"     In this open label study, 50 eligible women will be assigned to receive the investigational     product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for     the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at     baseline and after 2 and 6 weeks of treatment.      The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the     treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).   "
74277|NCT02313532|"     Study goal - to describe pediatric patients with febrile disease that administered to the     emergency department (ED) of hillel-yaffe hospital, according to arrival diagnosis, ED     diagnosis, given therapy, and therapy concordance with the guidelines and final diagnosis.      This research will describe cases that arrived to the hospital with acute febrile disease (up     to seven days of fever), the antibiotic treatment given in the community according to the     anamnesis and the community physician letter, therapy concordance with the guidelines, the ED     diagnosis and changes in therapy, and final diagnosis according to extended microbiological     examinations and panel of infectious disease specialists.   "
74278|NCT02313519|"     Based on the need of large-scale, trials to explore the use of probiotics to reduce     post-operative complication rate, a randomized controlled trial is designed to investigate     the impact of a probiotics treatment protocol on postoperative morbidity in an open elective     colonic surgery cohort. The major objective is reduction of post-operative complications     after 30 days.   "
74279|NCT02313506|"     Physical activity is an essential first-line treatment for patients with knee osteoarthritis     (OA). However, a 2013 systematic review found only 13% met the activity recommendation of 150     minutes or more per week. The primary goal of this pilot randomized controlled trail is to     assess the feasibility and preliminary efficacy of a multi-component intervention/model of     care involving a group education session, use of the Fitbit Flex (a wireless physical     activity tracking device), and weekly telephone counselling by a physiotherapist (PT) to     improve physical activity and reduce sedentary time in patients with knee OA.   "
74280|NCT02313493|"     In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent     training- are investigated. Healthy becoming first time parents were randomly allocated to     either the Baby Triple P parent-training group or a care as usual control group. It is     expected that 78 couples of becoming first time parents are recruited. It is hypothesized     that parents and their infants in the parent training group will show significantly less     psychopathology / regulation problems and better partnership quality than participants in the     control condition.   "
74281|NCT02313480|"     To date, the benefits of massage in chronic neck pain patients has only been investigated as     a singular treatment, rather than as part of a treatment package. The need for this research     has been highlighted in the literature (Ezzo et al, 2007; Haraldsson et al, 2006) This     research aimed to establish whether the addition of massage to a program of exercise and     manual therapy offers any additional benefits over exercise and manual therapy alone in the     treatment of patients with chronic neck pain.   "
74282|NCT02313467|"     In this study, the investigators are going to compare the clinical effect and safety of     topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the     treatment of acne.   "
74283|NCT02313441|"     Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary     intervention (PCI) and is associated with subsequent cardiovascular events. This study     assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in     patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients     received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg     around the upper arm, separated by 5-minute intervals of reperfusion) < 2 hours before the     PCI procedure, and the control group (n = 100).   "
74285|NCT02313415|"     Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial     dysplasia by collagen scaffold loaded with umbilical cord blood-derived mesenchymal stem     cells, and to provide clinical evidence for the treatment of uterine infertility.   "
74286|NCT02313402|"     Eighteen ALS patients will be trained to control a new communication device (Eye On Line:     EOL) that permit over smooth eye movements to generate digits, letters, words or drawing at     will. The intervention consists in a training program during six visits over 3 weeks on site     allowing a gradual acquisition of the eye-writing. The primary objective of the study is to     assess the feasibility of the use of EOL device in ALS patients. The EOL device potentially     offers a creative and personal means of linguistic and emotional expression in subject with     motor disability.   "
74560|NCT02309827|"     This study is a first in human study of PF-06651600. PF-06651600 is being developed for     treatment of inflammatory bowel disease. This study will test single and multiple doses of     PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics     and pharmacodynamics of PF-06651600 in healthy volunteers.   "
74287|NCT02313389|"     Hypothesis      Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained     after a standard induction chemotherapy with an acceptable toxicity in the elderly.      Rationale        -  Treatment of the elderly is challenging, indeed age over 60 is associated both with a          poor prognosis and a high risk of treatment induced neurotoxicity with devastating          consequences on quality of life. Therefore it has become standard practice to treat          elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone,          avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.        -  There is a clear need to improve disease control after induction chemotherapy. Since          consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are          either poorly effective and/or too toxic in the elderly population, maintenance          chemotherapy is an interesting alternative approach. Several agents, such as high-dose          MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable          safety profile, as single agent or combined, are good candidates for maintenance   "
74288|NCT02313376|"     Study designed to evaluate safety and tolerability of a genetically attenuated P. falciparum     (GAP3KO) that arrests early in the liver stage of the parasite life cycle. Study will also     confirm the attenuation of the GAP3KO parasites using peripheral blood smears. Secondary     objectives are to evaluate the humoral immune responses to GAP3KO.   "
74289|NCT02313363|"     The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS).     This study was aimed to test the feasibility of the PSDCS.   "
74290|NCT02313350|"     Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is the     gold-standard and the only controlled treatment in case of failure of conservative treatment.      Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery.      In addition, Discogel® chemonucleolysis appears as a relatively innocuous technique which may     avoid 2% complications after disc surgery and 5% repeated surgery (according to recent     trials).      This will be the first randomized trial comparing Discogel® chemonucleolysis versus surgery     in patients with sciatica due to lumbar disc herniation and unresponsive to conservative     medical treatments (including epidural steroid injections) Our expectation is that Discogel®     chemonucleolysis will avoid surgery in 80% of the patients.   "
74291|NCT02313337|"     The study purpose is to compare the effect of different Administration Routes of Pediatric     Premedication (including oral administration, intramuscular injection, rectal perfusion,     intranasal).   "
74292|NCT02313324|"     The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy     (ESWT) on the outcomes of coccydynia.   "
74293|NCT02313311|"     The objective of this study is to establish a hierarchical embryo selection process by using     the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.   "
74294|NCT02313298|"     A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late     toxicity and secondarily PSA outcomes and quality of life measurements of an extreme     hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.   "
74295|NCT02313285|"     Primary Objective:      To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who     received prior treatment during the TDU13475 or TDU14981 studies.      Secondary Objectives:      To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the     pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668 in     patients with MS.   "
74296|NCT02313272|"     The purpose of this study is to see if the addition of the investigation drug called     pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can     help with controlling the growth of tumors, in participants with recurrent high grade glioma.   "
74326|NCT02312882|"     The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus     kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia     areata and its variants.   "
74297|NCT02313259|"     The purpose of the study was (1) to determine thresholds for discriminating speed in     peripheral fields of patients with dry AMD and (2) to examine the driving skills of licensed     drivers with early dry AMD using a driving simulator and to investigate how their healthy     counterparts perform on the same driving tasks. We hypothesized that speed discrimination may     be better in patients with dry AMD than in healthy control subjects.   "
74298|NCT02313246|"     This study evaluates the effectiveness of a group cognitive behaviour therapy for Irritable     Bowel Syndrome (IBS) in decreasing symptoms of IBS, improving quality of life, and     normalizing the gut microbiome. Patients will complete an 11-week group cognitive behaviour     therapy for IBS within 1 month of being deemed eligible for the study.   "
74299|NCT02313233|"     To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to     the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of     Umooze twice daily administration for 56 days in patients with BPH.   "
74300|NCT02313220|"     Obesity is a medical condition which increases the risk of other diseases, such as type 2     diabetes and cardiovascular disease. Obesity-related risk factors for the development of     other metabolic diseases include unstable glucose levels and high blood pressure.     Dapagliflozin and exenatide are both approved worldwide for treatment of patients with Type 2     Diabetes. Dapagliflozin works by lowering glucose levels by inhibiting the renal reabsorption     of glucose and thereby promoting its urinary excretion and energy loss and thereby reduction     in body fat. Exenatide exhibits many of the same glucose-lowering actions of that of a     naturally occurring hormone and leads to weight loss mainly via reduced energy intake, most     likely via a central effect on appetite regulation. The purpose of this exploratory study is     to investigate if a combination treatment with dapagliflozin and exenatide have a synergistic     effect on weight loss in non-diabetic obese subjects. Subjects will be treated for 24 weeks     with either active combination treatment or placebo (non-active treatment). Neither study     personnel nor subjects will know what treatment is given. All subjects completing the 24-week     double-blind study and who are willing and eligible will be offered to enter a 28-week     open-label extension study. All subjects entering the extension study will receive unblinded     active study treatment for an additional 28 weeks. Thus the total treatment period for     subjects entering the extension study will be 52 weeks.   "
74611|NCT02309164|"     This study aims to determine the effectiveness of the use of acupuncture in relieving sensory     and motor symptoms as well as functional impairment and quality of life of patients with     chemotherapy induced peripheral neuropathy   "
74301|NCT02313207|"     This study will assess dynamic effects of two major antigens on the duodenal mucosa by     confocal laser endomicroscopy (CLE). Patients will be blinded to the antigens used (wheat,     yeast). Following CLE it is planned to have a cross over exclusion diet with/without the     antigens including a washout phase. Furthermore, patients will undergo a 2 week FODMAP diet     to be able to compare results found of both diets and allow to understand whether our     findings of food intolerance will be better and more precise than a common FODMAP diet.      Post CLE food challenge patients biopsies will be taken for histology. They will then be     randomized into two groups and blinded to the diet they undergo. They will be provided with a     supply of custom-made bread they will have for 2 weeks (custom made by a bakery in Kiel). For     one study arm bread will contain either wheat and yeast, for the other arm the bread will not     contain these ingredients. The taste of the normal bread will be denaturised. Crossover     will take place after a two-week washout phase.   "
74302|NCT02313194|"     This study is designed to assess the strategy of using spinal cord stimulation to improve the     ability to move in spinal cord injured humans.   "
74303|NCT02313181|"     This is a randomized, controlled trial designed to evaluate a new strategy for promoting     continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn     period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed     to each baby by syringe after each breastfeeding prior to the onset of mature milk     production. The study intervention is discontinued at the onset of mature milk production,     and the investigators will then follow mothers and infants for 12 months to assess the effect     of ELF on breastfeeding duration, maternal experience and healthcare utilization.   "
74304|NCT02313168|"     The F.R.O.N.T. formula for pre-operative airway assessment and documentation      Background:      Prediction of difficult airway is one of the most important challenges before general     anesthesia. Although in recent decades different scoring systems have been for the     preoperative assessment of their sensitivity and specificity in predicting a difficult airway     remains moderate. Recently, the calculation of composite scores using different formulae has     been proposed as the most sensitive one. The aim of the present work was to test the clinical     usefulness of the FRONT score, a recently developed scoring system.      Methods:      This study was a multi-center, inter-observer, prospective and double-blind investigation     that included 976 patients from two university centers: 250 from the University of     Cluj-Napoca, Romania, and 726 from the University of Debrecen, Hungary.      The preoperative evaluation of the patients was performed by a preoperative team of     anesthesiologists (team A) who evaluated and scored the expected difficulty of the management     of the airway. An intraoperative team of evaluators (team B) working independently from team     A, performed the actual instrumentation of the airway and scored the actual findings. Both     teams used the FRONT scoring system and worked independently from each other to ensure     blinded assessment. Statistical analysis of the preoperative and intraoperative FRONT scores     were performed post hoc.   "
74305|NCT02313155|"     The purpose of this study is to evaluate the safety and immunogenicity of a single     subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in     healthy Japanese adults   "
74306|NCT02313142|"     One of the major issues in space explorations is the negative effect of prolonged exposure to     very low gravity (i.e. a condition often referred to as microgravity or weightlessness) on     astronauts' health. In this unusual condition the human body undergoes an adaptation process,     often referred to as deconditioning, that leads to significant loss of bone and muscle     mass, hormonal changes, as well as modifications of important cardiovascular parameters.     While the new physiological state is adequate to the microgravity environment, it results     unsuitable upon return on earth. Hence after the mission astronauts experience various     health-related problems and must undertake an intense rehabilitation program. Cardiovascular     deconditioning originates mainly from a shift of blood from the lower extremities to the     upper part of the body caused by the absence of gravity. In the long term (i.e. days) this     causes a loss of blood and body fluid. In the short term (i.e. minutes) it elicits     modifications to arterial blood pressure and heart rate.      In this study, funded by the European Union through the project STAMAS, we intend to evaluate     whether leg physical exercises can lead to a displacement of blood towards the lower     extremities, therefore ameliorating the upward fluid shift caused by weightlessness. More     generally, we aim to investigate the short-term response of the cardiovascular system to leg     exercises in microgravity-like conditions. After a clear understanding of these phenomena we     will develop a controller that, by monitoring the physiological stare of a subject, will     compute the appropriate exercise regime to stabilize his/her cardiovascular parameters to     desired safe values. Our contribution will provide a better understanding of the     cardiovascular system, and will delineate the physiological ground for the development of     novel countermeasure devices against the cardiovascular deconditioning during space flight     based on continuous leg exercises.      The protocol we propose in this document presents minimal risks for our potential subjects,     while has the potential to produce important contributions. The cardiovascular parameters we     intend to analyse are: blood pressure, heart rate and leg blood volume. These signals will be     acquired non-invasively and with minimal risks. Leg exercises will be performed by means of a     stepping device (MARCOS) previously developed in our Lab. MARCOS enables to vary the     resistance applied against knee-extension movements, and therefore it allows a systematic     evaluation of different exercise intensities. Finally, microgravity conditions can be easily     emulated by letting the subjects lay on a tilted platform with head-down (i.e. head-down bed     rest - HDBR, or head-down tilt - HDT) during the exercise sessions, thus inducing a shift of     body fluid toward the thorax. The most effective inclination angle has proved to be as low as     -6°, thus constituting only minimal risks for the subjects. In practice, subjects will     comfortably lay on the negatively tilted platform and will perform stepping at different     intensities while their cardiovascular parameters are being monitored and recorded in     encrypted form for subsequent analysis.   "
74319|NCT02312973|"     The study investigates the pharmacokinetics (absorption, distribution, elimination) of     molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring     hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In     addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as     the safety and tolerability of molidustat.   "
74320|NCT02312960|"     Patients will be followed up in this study after prior treatment with BAY 88-8223 /     Radium-223 dichloride / Xofigo .   "
74307|NCT02313129|"     The purpose of this study is to increase our understanding of infertility in women with     Rheumatoid Arthritis (RA). In this study the study team will compare the differences in     ovarian reserve (the ability to provide egg cells that are capable of fertilization), the     frequency of ovulation and the number of pregnancies between women with and without RA. It is     possible that RA activity and medications limit ovarian reserve and ovulation, which may     increase infertility among women with RA. There are several suspected causes for infertility     in RA, including age-related fertility decline, inflammatory changes that impact endometrial     receptivity and discourage implantation, accelerated ovarian decline due to certain arthritis     medications and increased frequency of anovulation (a menstrual cycle during which ovaries do     not release an egg) due to RA activity.      This study is the first step toward our long term goal of increasing the ability of all women     with RA to build the family they desire.   "
74308|NCT02313116|"     This intraoperative study is a prospective study analyzing specimens from fifty subjects.     Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with     the inclusion and exclusion criteria. The study period per subject is the time it takes to     assess the ex vivo breast tissue sample using the study device. Image review will be     conducted during surgery and compared to the margin status findings in the post-operative     pathology report.   "
74309|NCT02313103|"     This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult     subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with     normal renal function, recruited as 1:1 matches to each ESRD subjects, matched for gender,     age, and BMI.   "
74310|NCT02313090|"     The aim was to assess the impact of a cell phone-based diabetes management application     (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure     during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang,     their diabetes knowledge and self-care behaviors were also evaluated.   "
74311|NCT02313077|"     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and     Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.   "
74312|NCT02313064|"     This will be the first-in-human (FIH) study with the oral formulation of CXA-10. The main     purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of     CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy     volunteers (Part A). The effects of food on the PK of CXA-10 will also be investigated (Part     B).   "
74313|NCT02313051|"     Everolimus has been approved to be effective when used with exemestane after progression on     non-steroidal aromatase inhibitors in postmenopausal women based on the BOLERO-2 clinical     trial. However, the superiority of addition of everolimus to endocrine therapy hasn't been     established in the premenopausal women. This is a phase 2, multicentre clinical trial to     evaluate the role of everolimus in the first-line endocrine treatment of premenopausal MBC     patients after progression on tamoxifen.   "
74624|NCT02308995|"     The aim of this randomized controlled trial is to compare operative data and early     postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with     those of laparoscopic excision of endometrioma using conventional sutures.   "
74314|NCT02313038|"     Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug     eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and     of high cost, however the knowledge about the real-life DES use and the efficacy and safety     in China is limited. By consecutively recruiting first-ever PCI patients in 30 geographically     representative highest-rank hospitals, this study will examine the prognosis in groups with     different brands of DES, and various real-life factors, that may affect patients recovery     after the procedure. Evidence for clinical practice and health resource allocation will be     established based on the findings, to improve patients outcomes in future finally.   "
74315|NCT02313025|"     The language intervention 'Kaatje Klank' is designed for stimulating the speech production     and speech perception skills of 4-year-olds in an early childhood educational setting, in     order to stimulate early literacy skills. These skills are crucial skills for technical     reading in later ages. Good reading skills are an important condition for academic success.      To measure the effect of the language intervention 'Kaatje Klank', the intervention will be     applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50%     non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a     coaching trajectory.To measure the effect on speech production and perception skills, a pre-     and posttest and a comparison with a matched control group (n = 100 children, 50% native     speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a     different language intervention which focuses on vocabulary development (World-project).   "
74316|NCT02313012|"     The CC-90003-ST -001 trial is a first-in-man, open-label study in subjects with     locally-advanced or wide spread cancers to determine if CC-90003 (an oral medication) can be     adequately tolerated with minimal side effects.   "
74317|NCT02312999|"     Study goal: This study will examine whether there is a significant difference in     postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.      Hypothesis: Perioperative fluid optimization through the use of a closed-loop assistance with     a balanced starch solution (volulyte®) will be associated with a decrease in postoperative     complications compared to the same approach using a balanced crystalloid solution     (Plasmalyte®).      Objective: To establish which kind of intravenous fluid used for goal directed therapy with     closed-loop assistance will reduce the number of postoperative complications (evaluation made     by the POMS score).   "
74318|NCT02312986|"     This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to     suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with     recurrent MDRO infections due to organisms of likely enteric origin.      FMT will be performed on subjects with a history of at least three recurrent infections due     to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or     at least two recurrent infections due to MDRO for which only antimicrobials with rate     limiting toxicities are available.      The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will     be able to prevent additional recurrences of infections due to MDRO by suppressing or     reversing enteric colonization with MDRO.   "
74327|NCT02312869|"     In the general intensive care unit (ICU) population, there is strong evidence for benefit     from lung-protective mechanical ventilation, including the use of low tidal volumes and     adequate levels of positive end-expiratory pressure (PEEP). In burn patients it is highly     uncertain whether these settings are beneficial and there are even concerns over safety of,     in particular use of low tidal volumes. There is lack of international guidelines and     consequently ventilation practice in burn patients may widely vary.      The primary objective is to determine ventilation practice in burn ICUs worldwide, focusing     on the size of tidal volumes and the levels of PEEP used for burn patients. In addition, data     on other strategies considered important in patients who receive ventilation are also     collected, including data on neuromuscular blocking agents, sedatives and analgesics, and     type and amount of intravenous fluids used in the period of ventilation. The secondary     objective is to determine the association between tidal volume size and levels of PEEP, and     duration of ventilation in burn patients.   "
74328|NCT02312856|"     This study is designed to evaluate the safety of the PulseRider in patients undergoing     treatment for bifurcation basilar or carotid terminus aneurysms.   "
74329|NCT02312843|"     The purpose of this research study is to examine the effects of high and low intensity     exercise for those with mild memory loss and pre-diabetes. The investigators will also     examine the effects of this exercise on certain proteins and hormones in body fluids, and on     brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate     that exercise improves memory and thinking abilities for adults with mild memory loss OR     pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND     pre-diabetes.   "
74330|NCT02312830|"     With the increasing successful use of allogeneic hematopoietic stem cell transplantation     (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term     effects of such a drastic treatment.      This study investigates the prevalence of several demographic, psychosocial and behavioral     aspects of survivorship after an allogeneic transplantation. Income, return to work, social     isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking     habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional     status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality     and resilience will be studied.   "
74331|NCT02312817|"     Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and     one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk     patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic     status patients receiving care through safety-net health systems. Screening and follow-up     failures lead to more advanced cancers, when curative therapies are not available and     survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to     poor recognition of high-risk patients, underuse of screening among these patients, and poor     follow-up of abnormal screening tests. To address these barriers, the investigators propose     to conduct a comparative effectiveness research randomized controlled trial of three     screening strategies among a socioeconomically disadvantaged and racially diverse cohort of     cirrhotic patients at high risk for developing HCC.      Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be     randomized to:        -  Group 1: Usual care, with visit-based HCC screening per discretion of individual          providers        -  Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource          intensity)        -  Group 3: Mailed HCC screening invitation outreach to eligible patients combined with          centralized patient navigation to promote screening completion and follow-up (high          resource intensity)      Through three specific aims, this effectiveness research randomized controlled trial will:        -  Aim 1: Engage stakeholders in design and implementation of HCC screening outreach          interventions.        -  Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention          strategies to increase completion of one-time and repeat HCC screening.        -  Aim 3: Evaluate whether intervention effects are moderated by patient sex, race,          ethnicity, English proficiency, and connectedness to primary care.      The screening intervention strategies combine EMR-enabled case identification, system-level     screening outreach, and patient navigation to improve identification of previously     unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up     of abnormal screening tests. This study will engage stakeholders throughout the research     process, evaluate the effectiveness and acceptability of HCC screening strategies, and     determine which patient subgroups benefit the most.   "
74332|NCT02312804|"     This study will be conducted using 3+3 design and includes, a dose escalation part to define     the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion     part to treat another 12 patients (only cervix cancer) to further evaluate safety of this     combination. Safety, tolerability and MTD will be determined in the dose escalation part of     the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy     in cervical cancer. The dosing cycle is 21 days.   "
74333|NCT02312791|"     Understanding patient's prognosis is of utmost importance to determine radiotherapy's     indication and dose/ fractionation. The investigators plan to conduct an observational study     of prognosis of inpatients evaluated for palliative radiotherapy at a large cancer hospital     in Brazil.   "
74334|NCT02312778|"     Non-specific low back pain is defined as a pain with no specific vertebral-related cause,     such as infectious disease, tumor, osteoporosis, fracture, structural abnormality,     inflammatory disease, radicular compressive syndrome or cauda equine syndrome. Non-specific     low back pain is a common disease in many countries. This musculoskeletal disorder is costly     to public health systems. Therefore, the use of manual therapies is important in the     treatment of this disease and studies show the effectiveness of this type of therapy.      Spinal manipulation is applied in manual therapies such as Osteopathy, Chiropractic and     Physical Therapy and is widely used for acute and chronic non-specific low-back pain. There     is moderate evidence that spinal manipulation is superior to sham spinal manipulation for     improving short-term pain and function in chronic and acute non-specific low back pain.     However the therapeutic mechanisms involved in this procedure are not well understood.     Furthermore, while the high velocity and low amplitude spinal therapy has been shown to be     effective in reducing pain and improving functional capacity in subjects with non-specific     low back pain, the effect on postural variables have not been investigated. Therefore, the     aim of this study is to evaluate the acute effect of lumbar manipulation on pain and postural     variables.      Twenty-four individuals with non-specific low back pain will be randomly allocated to two     groups. The intervention group will receive high velocity and low amplitude spinal therapy,     while the control group will receive sham manipulation. Immediately before and after the     respective manipulation protocol, both groups will be evaluated regarding pain level, using a     visual-analogue scale and algometer, and postural variables, using center of pressure     displacement measured with the aid of a force plate. While the patient and therapist     manipulator will be aware of the protocol applied in each case, the evaluator will be blind.     A statistical treatment will be used to compare the results.   "
74335|NCT02312765|"     Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients     with heart failure. Helping patients to effectively use the most common form of treatment for     sleep apnea, positive airway pressure therapy, can improve their heart function. This can     reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs has     developed an innovative solution that allows patients to communicate with health care     providers 24 hours a day, thus allowing them to get the help they need to effectively use     positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.   "
74336|NCT02312752|"     The purpose of the study is to determine whether a particular type of nerve fibers, A-delta     fibers, can be tested in an Electromyography (EMG) lab on a routine basis. Normal, healthy     volunteers will be enrolled in this study.   "
74337|NCT02312739|"     This is a randomized, double blind study that aims to measure the difference in maximum pain     experienced during in-office transcervical sterilization (Essure®) for women receiving either     inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen.      The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced     more than standard oral medications in women undergoing in-office transcervical     sterilization.   "
74338|NCT02312726|"     The primary objective of this mixed methods pilot study is to understand women's experiences     with postplacental intrauterine device (IUD) insertion through postpartum semi-structured     interviews. For secondary objectives, the investigators will collect visual analog scale     (VAS) and verbal rating score (VRS) data on women's pain experienced just before and     immediately after IUD insertion. The investigators will perform postpartum interviews in each     group until we reach thematic saturation. The investigators will recruit at least 60 women     (30 each in the epidural and no epidural group) from the University of New Mexico Hospital     (UNMH) affiliated antenatal clinics to conduct our quantitative data analysis.   "
74339|NCT02312713|"     The purpose of this study is to examine the effectiveness of standard physical therapy and an     internet-based exercise program for people with knee osteoarthritis (OA). Both of these     programs will be compared to a waiting list control group. The investigators hypothesize     that both treatments will result in greater improvement than the control condition and that     the treatments will be similarly effective. The investigators also expect that some patients     may do better with one treatment type or another and will explore this.   "
74340|NCT02312700|"     The study is aimed to verify the effect of an online interactive tool on patient empowerment.     The tool is based on a validated psychological questionnaire administrated to breast cancer     patients before their first encounter with physician.   "
74341|NCT02312687|"     UX023-CL203 is a Phase 2b, open-label, long-term extension study. The study will be conducted     in adults to assess the safety and pharmacodynamics of KRN23 administered via subcutaneous     injections monthly (every 4 weeks) for a total of 68 weeks. The study will enroll     approximately 25 adults with XLH who participated in Kyowa Hakko Kirin Pharma, Inc.'s (KHK's)     study KRN23-INT-001 or KRN23-INT-002. Subjects will need to discontinue oral phosphate and     vitamin D metabolite therapy prior to enrollment and throughout the duration of the study.   "
74342|NCT02312674|"     The aim of the randomized controlled study is to determine effects of an adjusted amount of     oral nutritional supplements on the quality of life, the nutritional status, side effects,     and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving     palliative therapy.   "
74343|NCT02312661|"     Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway     and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian     cancer. Metformin is a biguanide, widely used in the treatment of type 2 diabetes mellitus,     that has shown anti-cancer activity in preclinical studies. The main mechanism of metformin's     effect is mTOR pathway inhibition and, in addition, it has been shown to circumvent     p53-induced apoptosis making it an exciting, potentially effective drug in ovarian cancer.   "
74344|NCT02312648|"     The objective of this study is to investigate the effects of a program of early mobilization     in the functional capacity in patients undergoing coronary artery bypass grafting in short     and long- term.   "
74345|NCT02312635|"     Traumatic Brain Injury (TBI) is the most common cause of death and long-term disability in     children. Much of the long-term disability stems from neurocognitive impairments that are not     greatly helped by current cognitive training and pharmacological treatments for TBI related     cognitive impairments. This study tests the hypothesis that a drug, D-cycloserine (DCS), will     significantly enhance the effect of cognitive training in correcting cognitive impairments in     children with moderate/severe TBIs.      In order to do so, study subjects who fit inclusion criteria, including those with moderate     to severe TBI who show persistent working memory weaknesses based on a screening, will be     recruited. They will have three visits to UCLA. During the first visit, subjects will undergo     an MRI protocol before and after taking a pill (drug or placebo, blinded). They will also     participate in a number of paper and pencil cognitive tests. Then subjects will be enrolled     in a 6 week computerized cognitive training program (CogMed). They will also be prescribed a     drug/placebo pill (depending on which group they are randomized into), which they'll have to     take at regular intervals during the 6 weeks. They will have weekly check in phone calls or     visits by a coach trained in the program to make sure they are following the study protocol     accurately, to have their questions answered, and for motivation. At the end of the training     period, subjects will return to UCLA to again complete the MRI protocol and cognitive     testing. After three months of enrollment, they will have a final visit to UCLA, including     only cognitive testing. A total of 30 subjects will be entered into the study.   "
74346|NCT02312622|"     This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients     with non-small cell lung cancer, small cell lung cancer, or breast cancer that has spread to     the brain and does not respond to treatment. Pegylated irinotecan NKTR 102 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
74347|NCT02312609|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline     hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with     SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC     28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,     adult, human, male subjects under fed conditions.   "
74348|NCT02312596|"     A prospective, randomized, controlled, clinical study to establish clinical based evidence of     Eclipse PRP™ and compare its performance with the usual and customary practice for the     treatment of Wagner 1 or 2 DFUs.   "
74349|NCT02312583|"     iFighDepression is an online self-help programme based on cognitive-behavioral therapy that     could be useful for the treatment of mild to moderate depression   "
74350|NCT02312570|"     To assess the efficacy of the Eclipse PRP™ Wound Biomatrix and compare its performance with     usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).   "
74351|NCT02312557|"     This phase II trial studies how well pembrolizumab works in treating patients with prostate     cancer that has spread to other places in the body and keeps growing even when the amount of     testosterone in the body is reduced to very low levels despite previous treatment with     enzalutamide. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in     different ways by targeting certain cells.   "
74352|NCT02312544|"     To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost     drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic     Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension.     The study is designed to assess clinically meaningful response to treatment and is not     powered to measure any efficacy endpoints with statistical significance.   "
74404|NCT02311855|"     The main objective is to evaluate the strength and duration of immune response after     influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with     biological agents as compared to a group healthy controls who do not have RA. Influenza     vaccine titers will be drawn 3 times: at Baseline(prior to vaccination), 4-6 weeks post     vaccination, and 5-6 months post vaccination. Influenza vaccination will be done at the     baseline visit after the baseline blood draw.   "
74353|NCT02312531|"     In this study, HBV-infected pregnant women were divided into two groups, those who received     and those who did not receive hepatitis B immunoglobulin (HBIG) during pregnancy. In the     mothers, the changes in HBV serum markers (hepatitis B surface antigen (HBsAg), hepatitis B     surface antibody (HBsAb), HBeAg, hepatitis B core antibody (HBcAb)), and the DNA load were     investigated. Immunohistochemical staining with custom-made antibodies against HBIG revealed     both the level and distribution of HBIG in placentas. The protective mechanism of HBIG     administrated during pregnancy was explored.   "
74354|NCT02312518|"     To assess the efficacy of the Eclipse PRP™ Wound Biomatrix and compare its performance with     usual and customary practice for the treatment of chronic non-healing venous leg ulcers     (VLU).   "
74355|NCT02312505|"     The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output     monitoring system in patients undergoing elective cardiac surgery. The investigators     hypothesize that the semi-invasive device may be affected by mean arterial pressure and     systemic vascular resistance.   "
74356|NCT02312492|"     Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of     labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after     habituation to diets enriched in the corresponding fatty acid.      Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be     characterized by similar transport, higher conversion, and similar oxidation rates..   "
74357|NCT02312479|"     A prospective open-label, single treatment study to assess the safety and the performance of     the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea   "
74358|NCT02312466|"     The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the     authorities regarding iodine content in iodized salt. As a proxy for the entire population     the investigators will study school aged children, pregnant women and women of reproduction     age.   "
74359|NCT02312453|"     Abstract      Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its     course proximally, giving rise to impaired needle visualisation due to the steep angle of     needle insertion with the current ultrasound-guided approach. A new posterior parasagittal     in-plane ultrasound-guided infraclavicular approach was introduced to improve needle     visibility. However no further follow up study was done.      Methods: We performed a case series and a cadaveric dissection to assess its feasibility in a     single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November 2012     to October 2013. After obtaining approval from the Medical Ethics Committee, University     Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively     recruited. A cadaveric dissection was also performed. The endpoints of this study were the     success rate, performance time, total anaesthesia related time, quality of anaesthesia and     any incidence of complications.   "
74360|NCT02312440|"     Recently, there has been interest in applying tranexamic acid topically before the closure of     surgical wounds in total hip replacement. It has the advantages of ease of application,     maximum concentration at the site of bleeding, minimising its systematic absorption and,     potentially , decline the risks for systematic side-effects 。   "
74361|NCT02312427|"     We thought to investigate the influence of DPP-4 inhibitor on the serum BNP level of diabetic     patients with congestive heart failure. This study consists of two protocols. In the first     protocol, diabetic patients with high level of serum BNP (100-2000 pg/ml) receiving     outpatient treatment with any type of DPP-4 inhibitor at our institution will be enrolled.     After baseline data collection, DPP-4 inhibitor will be suspended for one month and serum BNP     will be measured. The DPP-4 inhibitor will be resumed and after another month, serum BNP will     be measured again. In the other protocol, diabetic patients who were hospitalized due to     heart failure were enrolled. DPP-4 inhibitor will be started after stabilization of heart     failure, and serum BNP will be measured before and after the drug administration.   "
74362|NCT02312414|"     Anemia is a common disorder in CKD patients. It is largely attributed to decreased     erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy includes     iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp) protein is     the main line of defense against the oxidative effects of Hemoglobin/Iron. There are 3     genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So far,     there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in     CKD patients.      In this proposed study we wished to examine whether Hp genotype influences intravenous iron     administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the     response of these patients to L-Carnitine therapy.   "
74363|NCT02312401|"     The purpose of this study is to better understand prostate cancer changes after radiation     treatment, through magnetic resonance imaging (MRI). MRI is an imaging test that allows     doctors to see prostate gland without any operation procedures. It can help identifying the     tumors in the prostate. For patients with newly diagnosed prostate cancer, MRI may help     doctors manage treatment better and sooner.   "
74364|NCT02312388|"     The purpose of this study is to compare the differences in central venous catheter insertion     time, success rate, and complication between thin-wall needle technique and     catheter-over-the-needle technique for central venous catheterization in children.   "
74365|NCT02312375|"     This study was designed to evaluate the effect of ARB in improving insulin secretion in     patients with type 2 diabetes. The investigators also aimed to evaluate if there are     potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and     urinary albumin secretion in diabetic patients.   "
74366|NCT02312362|"     Objective:      To compare intraocular pressure lowering effect of combined sclerotomy ab interno with     phacoemulsification and phacoemulsification alone, in primary or secondary open angle     glaucoma patients.      Study design:      Prospective, randomized, case- control interventional surgical trial   "
74367|NCT02312349|"     Celiac disease (CD) is a chronic autoimmune disorder in genetically susceptible individuals     characterized by inflammation of the small intestine due to gluten intolerance. This protein     is found in cereals such as wheat, barley and rye. In Argentina, oats are also considered a     toxic grain since are as highly contaminated as the previous three. For this reason, the     acronym TACC (Trigo, avena, cebada y centono: wheat, oats, barley and centono) is used for     their identification. An effective treatment for celiac disease consists in a gluten-free     diet (GFD). For most patients, a gluten-free intake results in a symptomatic and pathological     complete remission and decreases the risk of complications.      The overall prevalence of CD is around 1% in several Western countries. An Argentinian study     shows a 1.167 prevalence of CD in studied patients, being doubled for women than men. Another     study in a closed population of the Health Plan of Hospital Italiano de Bs As estimated a     prevalence of 0.22 CD diagnosis. In developed countries, for each diagnosed case there is an     average of 5-10 cases that have not been diagnosed yet.      CD patients and their families should be properly informed about GFD, since there are many     factors, voluntary and involuntary, which can affect the treatment. Even though a strict diet     is imperative, food handling awareness is equally important in order to prevent     cross-contamination and gluten intake hidden in certain products.      In recent years, several countries have shown an increasing interest in improving the supply     of gluten-free foods in supermarkets, food factories and restaurants. In turn, a British     study shows that chefs have less awareness about celiac disease than the overall population.     Another Canadian study, which assessed the quality of life of people with CD, revealed that     80% of them avoid eating in restaurants for fear of contamination, causing a decrease in     their social life.      In Argentina, there are associations that generate lists of marks and gluten-free products     allowing safe intake of processed foods, however, it is unknown the food supply suitable for     consumption for people with CD as well as the staff's knowledge in gluten-free food     preparation in restaurants, pubs, pizzerias and fast food places. U.S. has quality assurance     systems that certify good manufacturing practices and GFD handling in restaurants and selling     local foods, although its application is not mandatory. In our country, there is no such     certification, so food safety on restaurants can not be guaranteed.      Eating behaviors are influenced by the reality in which people live, including food     availability indoors and outdoors. The current lifestyle leads more and more people to make     meals away from home, so that the variety and quality of food sold in restaurants and other     stores conditions the consumption. Thus, the availability of safe foods in places where     people with CD carried some of their meals, help improve adherence to the GFD.      The aim of this study is to investigate gluten-free products' supply in elaborated food     stores in Buenos Aires City and to discover the level of information possessed by     manufacturers in the production of food.   "
74514|NCT02310425|"     Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial     infections and necrotizing enterocolitis (NEC) in the preterm infant. The effects of     probiotics on growth and development in premature infants have been investigated poorly.     Saccharomyces boulardii CNCM I-745 (S. boulardii) is a non-pathogenic probiotic yeast.      Prophylactic supplementation of S. boulardii at a dose of 50 mg/kg twice a day appeared to     bring preterm infants weight gain closer to that of intra-uterine growth rate, reduce feeding     intolerance, and had no adverse effects.   "
74368|NCT02312336|"     Patients with heart attacks caused by blocked coronary arteries are usually treated with a     technique called primary angioplasty. Although this treatment is very successful it can     result in damage to the heart muscle when the artery is opened due to reperfusion injury.     Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in     some patients but not in others, however it is uncomfortable due to the shivering, expensive     and can result in delays in opening the blocked artery. We are investigating a simpler way to     cool the heart muscle directly using cooled fluid passed through the catheter without the     shortcomings of entire body cooling. This pilot will address safety and feasibility     considerations.   "
74369|NCT02312323|"     Comparison of different contact lens materials.   "
74370|NCT02312310|"     to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin )     on dentate gyrus function and corresponding cognitive function   "
74371|NCT02312297|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline     hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with     SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC     28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,     adult, male, human subjects under fasting condition.   "
74372|NCT02312284|"     The aim of this observational study is to retrospectively collect current survival data for     3995 primary rectal cancer patients who were extracted from 5097 rectal cancer patients     admitted in Cancer Hospital, Chinese Academy of Medical Sciences from January 2000 to     December 2010. Moreover, based on a Cox model, we want to develope a nomogram that predicts     local recurrence, distant metastases, and survival for patients with rectal cancer treated     with pre- or postoperative chemoradiotherapy (CRT).   "
74373|NCT02312271|"     This prospective observational study seeks to assess ability to achieve enteral feeding goals     with standard tube feeding formulas.   "
74374|NCT02312258|"     The purpose of this study is to determine the effect of ixazomib maintenance therapy on     progression free survival (PFS) compared with placebo, in participants with newly diagnosed     multiple myeloma (NDMM) who have had a major response (complete response [CR], very good     partial response [VGPR], or partial response [PR]) to initial therapy and who have not     undergone stem-cell transplantation (SCT).   "
74375|NCT02312245|"     This phase II trial studies how well Avatar-directed chemotherapy works in treating patients     with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum     anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine hydrochloride,     pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may     interfere with the ability of tumor cells to grow and spread. Using an Avatar, a living tumor     sample with similar genetic characteristics to the original tumor, may help determine which     chemotherapy is most effective.   "
74376|NCT02312232|"     The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa,     3-OMD and ODM-104 after repeated doses of 3 levodopa formulations given in combination with     carbidopa and ODM-104.   "
74377|NCT02312219|"     HIV-infected individuals on antiretroviral therapy (ART) are at increased risk for     cardiovascular disease (CVD), likely due to chronically increased inflammation. Low-dose     methotrexate (LDMTX) may reduce CVD risk in people with rheumatoid arthritis, who like those     with HIV, have increased levels of inflammation. The NHLBI is funding a clinical trial     targeting the excess inflammation in HIV. That Parent Study is a randomized, double-blind,     placebo-controlled trial that will assess whether 24-week treatment with LDMTX: i) is safe,     ii) reduces circulating inflammatory biomarkers and levels of immune cell activation and iii)     improves brachial artery reactivity. However, neither the biomarkers nor endothelial function     tests measured as part of the parent study will report on atherosclerotic inflammation, (the     desired pathobiological target of LDMTX therapy in HIV). As such, the direct evaluation of     arterial inflammation would substantially enhance the scientific value of the trial. In this     imaging sub-study, the overall goal is to determine if treating virologically suppressed,     HIV-infected individuals with LDMTX will reduce inflammation within the arterial wall.      This fully integrated ancillary study would, in a subset of patients enrolled in the parent     trial: (i) assess the impact of LDMTX on arterial inflammation, (ii) evaluate mechanisms     responsible for arterial inflammation in HIV and iii) explore mechanisms responsible for     actions of LDMTX on the artery wall. Accordingly, the proposed study would provide unique and     highly complementary information that would greatly increase the knowledge and mechanistic     insights gained from Parent Study. The ancillary study has two specific aims1) To determine     the impact of anti-inflammatory treatment with LDMTX on arterial inflammation, as assessed by     FDG-PET/CT imaging, in virally suppressed HIV-infected individuals., and 2) To evaluate the     cellular and biochemical basis of the effect of LDMTX therapy on arterial inflammation in     HIV.   "
74378|NCT02312206|"     This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm     efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will     remain on-study until study completion, which will occur when all primary endpoint events     (all-cause mortality or cardiac hospitalizations) have been reached.   "
74401|NCT02311894|"     This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin)     (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to     prior recombinant human growth hormone (rhGH) treatment. The study is designed to     characterize the immunogenicity profile of somatropin (rDNA origin) injection when     administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will     also be assessed.   "
74379|NCT02312193|"     Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive     patients and to better understand the mechanisms controlling the myogenic tone. Evaluations     will be performed through ex vivo studies of peripheral arterioles in human adipose tissue     from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the     myogenic function in response to progressive blood pressure increases, in order to correlate     myogenic function to arterial hypertension and to the molecular mechanisms already identified     in the preclinical models.   "
74380|NCT02312180|"     ProMetic is intiitating a first-in-man study entitled A Phase 1, Dose Escalation, and     Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults     and Children with Hypoplasminogenemia. The general objectives of this clinical study,     (Protocol #2002C005G), are to determine the optimal dose and interval required to support the     planned Phase 2/3 study and to investigate initial safety and tolerability.   "
74381|NCT02312167|"     This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy     (pCLE) and needle-based confocal laser endomicroscopy (nCLE).      Contraindications for resection surgery may sometimes be missed during exploratory surgical     procedures. That may lead to an incomplete thus useless surgery and delay the right     treatment.      The objectives of this study are to improve the detection of cancer extension during     exploratory procedures and to guide resection to ensure clear margins.   "
80061|NCT02237950|"     A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on     alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in     women with a history of recurrent BV.   "
74382|NCT02312154|"     IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a     stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a     stamp-type electronic multineedle injector.      OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic     multineedle injector, and if changes in skin physiology occur earlier than in previous     trials.      DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center,     evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One     dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin     content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a     reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks     postinjection). The subjects and two independent investigators assessed the clinical     improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit.     Twenty-four participants completed the study, and no participants withdrew due to adverse     effects.      INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one     side of the lower cheek. The cheek side to which the treatment was applied was chosen     randomly.   "
74383|NCT02312128|"     The purpose of this study is to evaluate if an early mobilization after distal radius     fractures treated by surgery leads to an better functional outcome then immobilization after     surgery for 5 weeks in a cast   "
74384|NCT02312115|"     This study will be a randomized prospective double-blind placebo-controlled clinical pilot     trial. This will be a single center project that will take place at Loma Linda University     Medical Center. All adult kidney recipients will be informed of the study prior to operation.     The Nephrology fellows or attending physicians will attempt to obtain informed consent from     all eligible patients, pre-transplant. Those patients who consent will be screened post     operation for enrollment. Patients who do not meet all eligibility criteria and/or who meet     some exclusion criteria will be deemed ineligible for the trial, and will be excluded. The     Nephrology and Transplant teams will be blinded of patient assignment and only the pharmacy     will know the patient's assignment.   "
74385|NCT02312102|"     This research study is evaluating drugs called bortezomib and lenalidomide as a possible     treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).      The purpose of this research study is to determine the safety and efficacy of the bortezomib     and lenalidomide investigational combination. This drug combination has been used in the     treatment of relapsed/refractory multiple myeloma and has been previously investigated in the     treatment of MDS and AML, albeit at a lower dose of lenalidomide. In this research study, the     investigators are looking for the highest dose of the combination that can be given safely     and see how well it works as a combination for MDS and AML in individuals whose disease has     relapsed after an SCT.   "
74386|NCT02312089|"     Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist     (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI)     following GnRH antagonist protocol   "
74387|NCT02312076|"     Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist     (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI)     following long GnRHa protocol   "
74388|NCT02312063|"     In a prospective, randomized case-controlled study, the investigators hope to demonstrate a     positive correlation of plasma levels of EPA and DHA as well as fish intake with the     HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.   "
74389|NCT02312050|"     A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in     patients with chronic kidney disease caused by diabetes. The study will enroll approximately     375 patients at multiple centers located in the United States. Study duration is 6 months.     Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride     Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered     via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week     for an additional 4 months (16 weeks).   "
74390|NCT02312037|"     An expanded access/compassionate use protocol that allows access to Mylotarg for     relapsed/refractory AML CD33 positive patients in the USA.      Contact: B1761026@iconplc.com   "
74391|NCT02312024|"     Registry on the use of the CytoSorb® adsorber in ICU patients.   "
74392|NCT02312011|"     This study will test the safety, tolerability, and pharmacokinetics of multiple escalating     doses of ISIS-DMPKRx administered subcutaneously to adult patients with DM1.   "
74402|NCT02311881|"     The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR)     tablets administered orally, twice daily are effective and safe in the treatment of patients     with osteoarthritis of the knee or hip.   "
74393|NCT02311998|"     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     the combination of bosutinib and inotuzumab ozogamicin that can be given to patients with     Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia     (CML) in the lymphoid blast phase that also expresses CD22 (a type of protein on the leukemia     cell).      The goal of Part 2 is to learn if the dose found in Part 1 can help to control the disease.      The safety of this drug combination will also be studied.   "
74394|NCT02311985|"     The aim of this study is to compare three different blood transfusion strategies for     coagulopathy correction before central venous catheterization in patients with chronic liver     failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.   "
74425|NCT02311582|"     The blood brain barrier (BBB) is a major obstacle to drug delivery in the treatment of     malignant brain tumors including Glioblastoma multiforme (GBM). MRI-guided laser ablation     (MLA) has been noted to disrupt peritumoral BBB, which could then lead to increased access of     new tumor antigens to the lymphovascular system and vice versa of immune effector cells to     the tumor for effective activation of the immune system. Therefore the combination of MK-3475     and MLA as proposed in this protocol is hypothesized to create a therapeutic synergy in which     MLA increases material access to promote immune activation and then MK-3475 maximizes these     tumor-specific immune reactions to impart effective tumor control.   "
74515|NCT02310412|"     The objective of this study is to test the hypothesis that INTERCEPT platelet components     stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion     recovery and lifespan of 7-day old INTERCEPT platelet components stored in 35% plasma and 65%     InterSol or stored in 100% plasma, will be measured in comparison to fresh radiolabeled     platelets according to FDA guidance for platelet testing (FDA 1999).   "
74395|NCT02311972|"     Very low birth weight (VLBW) infants (<1500 grams at birth) and other low birth weight     infants experience hypothermia after birth and through stabilization (first 24 hours of life)     due to an inability to keep warm through metabolic heat production while experiencing heat     loss during care.      The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips     Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor with     a digital temperature display will enable care-providers to monitor continuous body     temperature and prompt them to provide warmth and prevent heat loss, thus preventing     hypothermia in these infants for the first 24 hours of life. The investigator predicts     infants in the intervention group will have warmer axillary temperatures upon admission to     the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for     consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW     infants and other low birth weight infants 1000-2000 grams will be randomized to the     intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel     monitor for continuous digital temperature display, immediately after birth through 24 hours     of life) or the control group (standard delivery room care and stabilization care). The study     staff plans to enroll 180 infants (90 per group) to allow for screen failures. Axillary     temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24 hours of age.     Further, the study staff intends to enroll approximately 300 Intensive Care Nursery providers     who care for an InnerSense study infant and wish to complete a provider satisfaction survey.     These providers will be asked to provide consent prior to completing the survey and their     names will be recorded on a separate study enrollment log.      Infant demographic data will be compared to make sure groups are not significantly different.     Temperatures from the intervention group will be compared to the control group using a     student t test at each time point. Satisfaction questionnaires will be summarized and     described. The InnerSense oral gastric tube with temperature monitoring is FDA approved for     use and is being marketed commercially by Philips Healthcare. VLBW infants have oral gastric     tubes placed as standard of care for feeding, and intermittently in the delivery room when     positive pressure ventilation is necessary for respiratory stabilization. There are no     additional safety risks to the intervention of this study; however, a safety/data monitoring     committee will be formed and meet quarterly to monitor the trial.   "
74396|NCT02311959|"     This is a phase III, multicentric, single arm study with a sequential design using the exact     conditional Poisson test.      The primary objective of this prospective study is to evaluate whether selected breast     carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable     low local recurrence rates.      450 patients will be included over a period of 4 years and will be followed for a 5 years     period (twice a year).      All patients must have a complete preoperative evaluation (bilateral mammography, bilateral     breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma     (invasive or in situ, all histopathological types, first treatment or relapse).      The study procedure is represented by nipple areola skin-sparing mastectomy followed by     immediate breast reconstruction.      After surgery, early and late complications, including specific complications (suffering of     the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.      An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be     realized throughout the study.      A complementary study, prospective, non-interventional, will be proposed to patients who will     benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in     the context of preventive surgery (prophylactic surgery for patients mutated or high genetic     risk). The aim of this complementary study, which will include a maximum of 60 patients, is     to evaluate associated morbidity in prophylactic NSM.      Data will be collected over a 3 months period after surgery.   "
74397|NCT02311946|"     This study will investigate whether concurrent administration of rabeprazole, an antacid     known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as     one of six experimental formulations.   "
74399|NCT02311920|"     This phase I trial studies the safety and best dose of ipilimumab, nivolumab, or both in     combination with temozolomide in treating patients with newly diagnosed glioblastoma or     gliosarcoma. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth     in different ways by targeting certain cells. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet     known which combination is a better treatment for glioblastoma or gliosarcoma.   "
74400|NCT02311907|"     This randomized phase III trial is studying glutathione to see how well it works in     preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with     ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help     prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known     whether glutathione is more effective than a placebo in preventing peripheral neuropathy.   "
74703|NCT02307955|"     The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot     to twitch, and has been shown to increase blood flow. The device is also indicated for the     treatment of oedema. In this study the investigators intend to assess the use of the device     as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.   "
74403|NCT02311868|"     The interest on gastrointestinal (GI) dysfunction in hemodialysis has been growing in the     last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to     systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the     blood. Another mechanism by which GI dysfunction contributes to systemic symptoms is related     to metabolic activity of the dysbiotic microflora growing in the gut of these patients to     generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has     strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in     hemodialysis patients. In the present paper the investigators investigated the effect of a     probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in     hemodialysis patients.   "
74449|NCT02311270|"     The purpose of this study is to learn about the effects of long term carnitine use in     patients with metabolic disorders and its potential relationship to cardiovascular events.   "
74405|NCT02311842|"     Ankylosing spondylitits (AS) is a chronic, systemic rheumatic disease primarily affecting     spine and sacroiliac joints, which belongs to the group of conditions known as     spondyloarthopathies and causes eventual fusion of the spine. Twin study in AS estimated a     heritability of over 90%. HLA-B27 is regarded as the earlist and most important gene     associated with AS heritability, and over 90% of AS patients carry HLA-B27 gene. HLA-B27 was     highly polymorphic, and more than 89 subtypes of B27 gene have been found. Subtypes of     HLA-B27 vary between different regions, and so on as the relationship between HLA-B27     subtypes and disease development among different races. Anti-TNF- agents were regarded as one     milestone in recent years development on treatment of ankylosing spondylitis, and most     patients showed significant improvement after anti-TNF- therapy. Yet part of patients still     showed insufficient response. Our previous study suggested AS patients carrying different     genotype of SNP in TNF gene had different response to anti-TNF- therapies. But more studies     should be carried out to identified more gene polymorphisms associated with treatment     response. In this study we designed a prospective, open-label trial to investigate the     genetic difference beween AS patients with different response to anti-TNF- therapy. We plan     to enroll 50-100 early AS patients which fulfill the 2009 ASAS axial spondyloarthritis     classification criteria and have axial symptom for no more than 2 years. The patients must     have high disease activity defined as BASDAI 4, and HLA-B27 test must be positive. The     patients should be able to receive 24 weeks of etanercept treatment. And patients who have     previous other anti-TNF- therapy and any contraindication of anti-TNF- therapy must be     excluded. Other medicines should be stable for at least 4 weeks before etanercept treatment     begins. For the clinic assessment, patients should fill in the AS questionaires and receive     physical examination at each visit. ASAS20 is thought as the primary endpoint. For the     genetic polymorphysm detection, we select 10-20 SNP in MHC region associated with AS and 5-10     HLA-B27 subtypes which have been worked over and have definite association with AS. At the     first visit 4ml of anticoagulated blood was collected and DNA was extracted. Target SNPs are     detected by PCR then direct sequencing. HLA-B27 subtypes are identified using PCRSSP methods.     And the relationship between SNPs/HLA-B27 subtypes and different response to anti TNF-     therapy is accessed using chi-square statistic process in SPSS software. In this study we     plan to investigate the relationship between genetic background and the clinical response to     anti-TNF- therapy in AS patients, which has been seldom reported before. Our group have been     studying the disease-associated gene of AS for years, and got plenty of data and experience     about genetic study of AS.   "
74406|NCT02311829|"     The goal of this study is to evaluate effectiveness of the phone follow-up method compared to     the conventional filler taken one.   "
74407|NCT02311816|"     The value of procalcitonin change from the day before to the day when infection was suspected     in predicting bacterial infection in intensive care patients.   "
74408|NCT02311803|"     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle     will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic     nerve preservation) surgery played a role in decreasing incidence of urinary and sexual     function disorder. However, 32%-44% patients still suffered from urinary and sexual function     disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).      In the early stage of work, the investigators performed preservation of Denovilliers' fascia     in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal     cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME     significantly decreased incidence of urinary and sexual function disorder. In order to     further confirm the early work, the investigators design a randomized controlled clinical     trial to compare differences in urinary and sexual function protection and long-term outcomes     between preservation and excision of Denovilliers' fascia in L-PANP-TME.   "
74410|NCT02311777|"     Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified     as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone     limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually     resistant to a wide variety of treatments (1-4). Three factors may contribute to the     development of persistent, post-amputation PLP by inducing central sensitization at different     times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute     postoperative pain (5-7).      Investigators hypothesis that pre-amputation period could be important in eliminating Phantom     Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The     reduction of pre-operative pain and prevention of formation of pain memories may eliminate     development of PLP by using dual networks treatment strategy. This Phase III, randomized,     double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative     pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing     lower limb amputation.   "
74411|NCT02311764|"     Open label, non-randomised phase II clinical pilot study   "
74412|NCT02311751|"     In this study, the investigators will be examining the effects of repetitive transcranial     magnetic stimulation (rTMS) on executive function deficits in individuals with autism     spectrum disorder. Half of the participants will be chosen by chance to receive active rTMS     stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel the     same as active rTMS only there will be no direct brain stimulation. This is necessary to     ensure that active rTMS is efficacious in the enhancement of executive function in     individuals with autism spectrum disorder. Based on results from a recently published pilot     study, the investigators propose that active rTMS treatment will result in a significant     improvement in working memory performance compared to sham rTMS treatment.   "
74450|NCT02311257|"     The purpose of this study is to learn about the use of nutritional supplements in patients     with mitochondrial disease.   "
74451|NCT02311244|"     This observational study is aimed at identifying new molecular promoters of mortality (and     morbidity) in patients with type 2 diabetes mellitus (T2DM).   "
74452|NCT02311231|"     In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone     (according to local protocol) in reducing death, MI, and major bleeding in patients with     NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.   "
74841|NCT02306148|"     The main objective of this trial is to investigate the effects of a training protocol for the     foot and ankle complex on the prevalence of running related injuries on long distance     runners.   "
74413|NCT02311738|"     Regular exercise has several positive health effects including increased physical fitness and     muscle mass. It is well known that increased muscle mass is associated with increased resting     energy expenditure which may facilitate weight loss and maintenance. Previous studies have,     however, failed to show any consistent association between the intensity of physical exercise     and energy expenditure, or relate the variance in these adaptations to genetic variability.     Whether high-intensity exercise (HIE) is associated with improved health related quality of     life in severely obese patients remains unknown.      This PhD-project is based on a planned randomised controlled study including 50 or more     treatment seeking morbidly obese patients who will be randomised to either a 24 week     moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE)     programme. The investigators main hypothesis is that patients randomised to the HIE-program     will achieve higher energy expenditure during rest and physical activity after treatment than     those allocated to the MIE-programme. In addition, the investigators hypothesise that the     HIE-group will achieve a better health related quality of life than the MIE-group after     treatment. The investigators also hypothesize that inter-individual variability in adaptation     to the two training regimens may be due to genetic factors. If the investigators hypotheses     are confirmed, this project might have beneficial clinical implications for future obesity     treatment strategies.   "
74414|NCT02311725|"     The overall aim of this program of research is to refine and test a newly developed     storytelling video intervention (sTVi) for depressed primary care patients.      The purpose of the proposed project is to establish the feasibility, acceptability, and     preliminary effects of the intervention for an eventual large-scale randomized clinical trial     which would test the efficacy of sTVi in comparison to a control condition.      To achieve the specific aims, the investigators will conduct a pilot randomized clinical     trial (n = 40), with two treatment arms: antidepressant treatment as usual (aTAU) + sTVI vs     aTAU + attention control videos.   "
74415|NCT02311712|"     The aim of this study is to assess the effects of implementation of a non-endoscopic     esophageal cancer-screening program on outcomes of interest in an asymptomatic high-risk     population in Golestan Province, Iran. Study population will be recruited in two arms. In the     intervention arm, cytological examination of the esophagus will be performed using a capsule     sponge device. Subjects in the control arm will receive no intervention. All participants     will be followed for 5 years. The outcomes of interest, including the incidence of esophageal     cancer as well as mortality rates, will be compared between the two groups.   "
74416|NCT02311699|"     Violence against women (VAW), the most extreme manifestation of the unequal power balance     between women and men, is a major global public health concern. One of the most common forms     of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of     women reported having experienced physical and/or sexual intimate partner violence (IPV) in     their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence     has also linked IPV and HIV risk.      This study is a cluster randomized controlled trial assessing the impact of a community-based     intervention focused on Intimate Partner Violence and HIV delivered in the context of the     Ethiopian coffee ceremony, a culturally established forum for community discussion and     conflict resolution. Villages will be randomly assigned to one of 4 study arms (3     intervention and one control arm): 1) Women only participate in the intervention, 2) Men only     participate, 3) Both men and women (couples) participate, 4) Women and men receive the     control intervention comprising a short informational session on violence reduction.   "
74417|NCT02311686|"     The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl     glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of     increasing doses of alcohol in adult subjects.   "
74418|NCT02311673|"     The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC)     injectable formulation of RM-493 in obese subjects with Prader-Willi syndrome on     tolerability, weight loss and hyperphagia-related behavior. The study drug (RM-493 and     placebo) will be administered in a blinded fashion.      Funding Source - FDA OOPD   "
74419|NCT02311660|"     This is an open label interventional study using an implantable vagus nerve stimulation     device in patients with Crohn's disease who have active disease despite treatment with a     tumor necrosis factor (TNF) antagonist drug.   "
74420|NCT02311647|"     The aim of this multi-center study is to assess the effects of Tamoxifen on the uterine     cavity and endometrial abnormalities in young premenopausal women diagnosed with breast     cancer.      The research contains two parts: a clinical study and a laboratory study.        -  Clinical part: to evaluate the association between tamoxifen treatment and uterine          abnormalities.        -  Laboratory part: to investigate the effect of Tamoxifen treatment on endometrial tissue,          by exploring the molecular aspect of endometrial receptivity.   "
74421|NCT02311634|"     The purpose of this study is to determine whether electrical pudendal nerve stimulation is     more effective than transvaginal electrical stimulation in treating urge urinary incontinence     (UUI).   "
74422|NCT02311621|"     Patients with recurrent or refractory neuroblastoma are resistance to conventional     chemotherapy. For this reason, the investigators are attempting to use T cells obtained     directly from the patient, which can be genetically modified to express a chimeric antigen     receptor (CAR). The CAR enables the T cell to recognize and kill the neuroblastoma cell     through the recognition of CD171, a protein expressed of the surface of the neuroblastoma     cell in patients with neuroblastoma. This is a phase 1 study designed to determine the     maximum tolerated dose of the CAR+ T cells.   "
74423|NCT02311608|"     To observe and access the Effects and safety of terlipressin or high dose     somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis in     patients with acute variceal bleeding.   "
74424|NCT02311595|"     The purpose of this study is to determine if reduced port totally laparoscopic distal     gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological     feasible.      67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced     port totally laparoscopic distal gastrectomy.      The primary end point of this study is to measure compliance rate with pathology report and     compare with previous compliance rate data.   "
74485|NCT02310802|"     The primary objective of this study is to assess the increase in clinical pregnancy rate     after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist,     compared to placebo.   "
74426|NCT02311569|"     The aim of this phase II study is to test a novel concept in the treatment of patients with     myeloproliferative neoplasms (MPN), a disease of the bone marrow. With no current cure     available, MPN are a group of chronic leukemias (blood cancers) in which patients produce too     many blood cells. These increased blood cell numbers cause problems to the patient such as     bleedings or thrombosis and some patients may progress to acute leukemia, a life threatening     condition. Most MPN patients have a gene mutation called JAK2-V617F. The disease is     maintained by mutant MPN stem cells that reside in the bone marrow in specialized locations     called niches. These niches need connections to the nervous system. New findings show that     these connections are destroyed by the presence of the mutated MPN stem cells. Research teams     found that some drugs (beta3-sympathicomimetics) can restore these damaged niches and at the     same time reduce the MPN disease manifestation in a mouse model of MPN. Such     sympathicomimetic drugs are already being used to treat patients with asthma or hyperactive     bladder. These drugs have shown to have only few side effects. The study tests the effects of     the beta-3-sympathicomimetic drug Mirabegron (Betmiga®) on MPN disease in 39 patients that     carry a JAK2-V617F mutation. The hypothesis is that Mirabegron will have a beneficial effect     on bone marrow niche cells and will thereby improve the disease manifestation in MPN     patients. This study should provide a rapid answer whether targeting the nervous system of     the niche cells could be useful for patients with MPN and warrants to be tested in larger and     more long-term studies.   "
74427|NCT02311556|"     This study is designed to evaluate whether advanced magnetic resonance imaging (MRI)     techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be     used to predict treatment response of brain metastasis after radiosurgery.   "
74428|NCT02311543|"     Axillary lymph node dissection remains an integral part of surgical treatment of primarily     node-positive invasive breast cancer. In order to reduce the incidence of clinically relevant     seroma, a suction drain is routinely placed into the axillary cavity after axillary lymph     node dissection (ALND) by a separate stab incision. The pathogenesis of seroma involves the     collection of lymph fluid caused by dissection of lymph vessels and exudate. All coagulation     and fibrinolytic factors are produced and secreted by lymphatic endothelial cells and are     involved in the sealing of lymphatic capillaries. Local hemostyptic agents may therefore     reduce postoperative secretion from lymphatic fistulas caused by ALND.      We propose to conduct a multicenter prospective randomized control trial in Switzerland to     evaluate the impact of TachoSil®, a ready-to-use, absorbable surgical patch (consisting of an     equine collagen sponge coated with human fibrinogen and human thrombin) on axillary drainage     after ALND for breast cancer. We hypothesize that the use of TachoSil® significantly and     relevantly reduces the volume and duration of axillary drainage after ALND. This has the     potential to increase patients' quality of life, as well as to shorten the length of hospital     stay and reduce hospital costs.   "
74429|NCT02311530|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended     release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories     Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)     manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP     Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.   "
74430|NCT02311517|"     Postoperative pain still remains a challenging problem in patients undergoing video-assisted     thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for     VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described     recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the     possibility to provide analgesia following thoracic surgery. Pain following surgery is a     critical side effect of surgery, which increases the risk of complications and delays a     recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the     quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided     SPB on the quality of recovery and pain in patients undergoing VATS.   "
74431|NCT02311504|"     In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive     survey are conducted after recruitment in secondary diabetes care centers. All patients     undergo a comprehensive eye examination including wide-angle fundus photograph and ocular     cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes     duration, type of treatment), knowledge and personal attitudes of the persons affected. The     relevant lab findings were collected from the electronic files.      Main focus of the study is the concordance to the national screening recommendations (last     eye exam, presence of retinopathy).   "
74432|NCT02311491|"     Purpose: The project aims to assess if hard ceramic coatings on orthodontic archwires will     reduce the sliding resistance of archwires in the brackets during orthodontic treatment     procedures.      Participants: Up to 80 subjects will be recruited for this study. Subjects between 10 years     of age and 45 years old will be otherwise healthy subjects previously diagnosed with     malocclusion.      Procedures (methods): Each subject will receive an experimental (coated) or a regular     (uncoated control) orthodontic archwire (AW) for a 3-month treatment. The 3D digital images     of each subject's dentition will be recorded three times at 0-, 6- and 12-week visits. The AW     will be removed and retrieved after the 3-month trial.   "
74433|NCT02311478|"     This study aims to use validated tools as well as new technology to examine changes in     bleeding patterns among women who are initiating the copper T380A IUD.   "
74434|NCT02311465|"     The purpose of this research study is to find out whether it is better to introduce cancer     patients to the palliative care team at a later date when there is a specific issue or     problem or to introduce cancer patients to the palliative care team when first diagnosed     before any specific issue or problem occurs.   "
74486|NCT02310789|"     Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced     expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement     in sweat chloride results.      To help understand why sweat chloride was unresponsive, the investigators will use a newly     developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic     fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil.      The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days)     will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by     measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.   "
74435|NCT02311452|"     Some children get serious bacterial infections that require hospitalization and then a long     course of antibiotics to completely treat the infection. Examples of these serious infections     include ruptured appendicitis (when the appendix gets inflamed and bursts, releasing bacteria     into the abdomen), complicated pneumonia (when an infected pocket of pus forms either in the     lung or between the lung and chest wall), and osteomyelitis (an infection of the bone). To     extend the duration of antibiotic therapy after discharge from the hospital, doctors will     often insert a long catheter called a PICC line in the child's vein, which can stay in the     body for several weeks. However, PICC lines require a fair amount of maintenance and training     of caregivers in their use, require children to restrict their activities, and can lead to     serious complications, such as blood stream infections and clots. An alternative to PICC     lines is extending the duration of antibiotic therapy with oral antibiotics (pills or syrup)     that achieve high levels of medicine in the blood and do not have the extra work,     inconvenience and risks of PICC lines. Unfortunately, there are very few high quality studies     that have demonstrated that oral antibiotics are just as good as intravenous antibiotics     delivered via a PICC line, and so many doctors still recommend the PICC line treatment     option. Also, no studies have been done to compare the impact of these two treatment options     on the quality of life of the child and their caregivers.      In this proposal the investigator outline a series of projects to compare oral antibiotics     vs. intravenous antibiotics delivered via a PICC line in children who require prolonged (at     least 1 week) home antibiotic therapy after hospitalization for three different serious     bacterial infections: ruptured appendicitis, complicated pneumonia, and osteomyelitis. To see     whether oral antibiotics are just as good as PICC lines, the investigators will use data     collected from over 15,000 children with one of these three infections who were hospitalized     at one of 43 US children's hospitals during the years 2009-2011, and determine whether PICC     lines resulted in fewer rehospitalizations for treatment failure than oral therapy.   "
74436|NCT02311439|"     This prospective cohort, phase II, trial is studying induction chemotherapy combination,     FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU),     for 4 cycles, followed by consolidation concurrent radiotherapy with capecitabine in     non-progressed cases, in treating patients with locally advanced cancer pancreas.   "
74437|NCT02311426|"     The study is a comparative effectiveness study with comparision of two cohorts of patients     with stroke in North of Norway and in Denmark. At baseline information is collected from the     stroke registries in both countries. Time points for follow up are at 3 and 12 months     post-stroke. Data are collected from medical charts and with use of telephone interview in     addition to self-report questionnaires. The study will provide information about mortality,     functional status and quality of life. Information about rehabilitation services in both     countries are collected and compared, and analysed in relation to patients outcome.   "
74438|NCT02311413|"     The goal of this study is to identify changes in cells that are related to the treatment with     Cat-PAD (ToleroMune Cat).   "
74439|NCT02311400|"     Background:      - People respond differently to life events and how those events make them feel. They also     respond differently to information about the how their actions affect their lives and health.     Researchers want to learn more about these differences. In this study, researchers will look     at how people respond to an event in their life. Researchers will also look at how people     respond to information about how their actions can affect their health.      Objective:      - To see how people respond differently to life events and information about alcohol and     breast cancer.      Eligibility:      - Women 18 and older who have never been diagnosed with cancer and who drank 5 or more     alcoholic drinks in the past week.      Design:        -  This study will take place online.        -  Participants will be randomly assigned to 1 of 10 groups.        -  Researchers will ask participants to take part in 2 small studies, 1 about Life Events          and 1      about Alcohol and Breast Cancer.        -  In the Life Events study, participants will write briefly about a time they felt very          happy, fearful, angry, or surprised, or they will write about a room in their house.          Then they will answer questions about that event. They also will write about a value          that is or is not important to them.        -  In the Alcohol and Breast Cancer study, participants will read a health message about          the link between alcohol and breast cancer. Then they will answer questions about what          they read and give their thoughts about alcohol and breast cancer.        -  Both studies should take about 30 minutes.   "
74440|NCT02311387|"     Background:      - Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow     fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and     droppings. When a group of researchers tested the mice in Soromba, Mali, they found that many     were infected with Lassa fever. Lassa fever may also be passed through body fluids (like     blood or semen) of people infected with Lassa fever. Researchers want to study this disease     to help the government better protect the health of people in Sibirila.      Objectives:      - To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how     many people get the disease every year.      Eligibility:      - People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no plans     to relocate within 1 year.      Design:        -  Households will be randomly selected to participate in the study.        -  Participants will have up to 20 drops of blood collected from the finger or heel.        -  Participants will be asked about their age. They will be asked if they have ever had a          fever and if they have ever seen mice in or around their home.        -  Researchers will come back in 1 year and take another drop of blood from the          participant. Participants will be asked the same questions.        -  If a participant has a fever at any time during the year, he or she should go to the          health center. Researchers      will collect a few drops of blood to test for Lassa fever.   "
74441|NCT02311374|"     Background:      - The glymphatic system helps keep harmful waste from building up in the brain. Researchers     think it is more active in people during sleep than while awake. They want to study the     glymphatic system using magnetic resonance imaging (MRI).      Objective:      - To see if there are differences in the way waste is removed from the brain while a person     is sleeping versus awake.      Eligibility:      - Healthy people age 18-60.      Design:        -  This study is in 2 parts.        -  For the technical part (discontinued), participants will be screened with medical          history and physical exam. They will have urine and breath alcohol tests.        -  Participants will have 2 MRI scans. Before the scans, they will have urine and breath          alcohol tests, and complete a questionnaire.        -  For MRI, participants will lie on a table that slides in and out of a metal cylinder. A          device will be placed over their head. They will lie still for up to 20 minutes at a          time. They may be asked to stay awake or fall asleep for up to 2 hours at a time.        -  For the research part, participants will be screened with medical history and physical          exam. They will have urine and breath alcohol tests. For 1 week they will wear a device          that monitors their activity and sleep.        -  Participants will stay at NIH overnight. They will give a blood sample, have urine and          breath alcohol tests, and complete a questionnaire.        -  Participants will take memory, concentration, and thinking tests.        -  Participants will have 3 MRI scans. An electroencephalography machine will record their          brain activity. Electrodes will be placed on their scalp.   "
74442|NCT02311361|"     Background:      - Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving     very focused beams of radiation to tumors. Researchers think that the drugs being used in     this study might work better when combined with SBRT in people with pancreatic cancer.      Objective:      - To study the safety and effectiveness of MEDI4736 and/or tremelimumab with SBRT.      Eligibility:      - People 18 and older who have pancreatic cancer that has not responded or to chemotherapy.     They must be candidates for radiation but not resection.      Design:        -  Participants will be screened with medical history and physical exam. They will have          blood tests. Their tumor will be measured using computerized tomography (CT) or magnetic          resonance imaging (MRI).        -  Participants will have their tumor biopsied with a needle. They will have also have a          biopsy after cycle 1.        -  Participants will get 1 or 2 drugs in combination with the SBRT.        -  For MEDI4736, the duration of each cycle will be 28-days. Participants will get the drug          through an intravenous (IV) infusion twice in each cycle (Days 1 and 15).        -  For tremelimumab, the duration of the first 6 cycles will each last 28 days. Then the          duration of the last 3 cycles will change to 12 weeks. Participants will get the drug          through an IV once in each cycle.        -  All participants will have SBRT. Some will get 1 dose of radiation and some will get 5.          CT scans will map their tumor.        -  Participants will have medical history, physical exam, and blood tests in each cycle.          They will have a CT scan or MRI every 8 weeks. Cycles will continue for up to 12 months.        -  Participants will be contacted yearly for follow-up.   "
74443|NCT02311348|"     Background: In a liver biopsy, a small piece of liver is removed. A percutaneous liver biopsy     (PLB) is done through a needle on the right side of your belly. In a transjugular liver     biopsy (TLB), the right side of the neck is numbed and a straw-like tube is put in. The tube     goes down to your liver and a piece of liver is removed. Researchers want to learn more about     the pain people feel after each of these procedures.      Objectives: To compare whether there is more pain associated with the PLB versus TLB.      Eligibility: Adults 18 years or older enrolled in a separate protocol (91-DK-0214) for liver     biopsy. They must be able to read, write, and speak English.      Design: Under the separate protocol (91-DK-0214), participants will be screened and have a     liver biopsy.      Before the biopsy, participants will give their medical history. They will answer questions     about past surgeries and how they feel about pain.      Participants will have a pain test with a device called a dolorimeter. They will sit up with     their feet on the ground, and put their thumbs on a table. They will feel pressure on each     thumb until it they say it is painful.      Before the biopsy and 2, 4, and 6 hours after the biopsy, they will answer pain questions.   "
74444|NCT02311335|"     Background:      - Genes are the instructions our body uses to function. Researchers can look for changes, or     variants, in the genes. The goal of this study is to find new gene changes that lead to lipid     disorders. Older research methods looked at one or a few genes at a time. Genomic sequencing     looks at most of the genes at once. Genomic sequencing may find the cause researchers haven t     been able to find from past methods.      Objectives:      - To better understand genetic causes of lipid disorders through genomic sequencing.      Eligibility:      - People age 2 and older with unusual lipid disorders, and their relatives.      Design:        -  Participants will be screened with a physical exam and medical history. They will have          blood taken. They may give a saliva sample.        -  Based on the screening test, researchers will chose 3 5 family members to perform the          genomic sequencing. The sequencing will be done on a sample of DNA collected during the          blood draw and saliva sample.        -  Participants may be invited to take part in other protocols that may involve imaging of          their heart or blood vessels. They do not have to participate. If they do, they will          sign a separate consent for those tests.        -  If a participant s family member cannot travel to the NIH, the NIH documents and consent          will be reviewed during a teleconference. A blood or sputum kit will be mailed to them.   "
74445|NCT02311322|"     Background:      - Some growth disorders are caused by a change in genes. Genes are the instructions the body     uses to function. Changes in genes often cause them not to work correctly. Researchers want     to use a new technology called exome sequencing, to look at many genes at once. This is done     by looking at DNA from blood or saliva in a lab. This method may help find the cause of     disorders that researchers haven t been able to find using past methods.      Objectives:      - To better understand genetic causes of growth disorders.      Eligibility:      - Children and adults with growth disorders and their family members.      Design:        -  Participants will give a small sample of blood and/or saliva.        -  Researchers will purify DNA from the sample. They will perform exome sequencing and          other tests to look for changes in genes. Some participants may receive limited or no          genetic tests. Researchers will let them know if exome sequencing is performed.        -  Participants may have a medical history, physical exam, and lab tests. They may have          x-rays or ultrasound tests to study the disorder in their family.        -  Some participants may be recommended for a specific genetic test from a commercial lab.          They may have to pay for that test.        -  Participants will be told about test results that relate to the growth disorder. This          may happen up to years after the testing. They may have to give another blood and/or          saliva sample.        -  Some participants may get results about other health conditions. This will only happen          if the information would help the person or their family protect their health. They may          have to give another blood and/or saliva sample.   "
74446|NCT02311309|"     Peroperative bleeding has been studied in specific populations exposed to bleeding (i.e.     cardiac surgery, orthopedic surgery). Epidemiology of peroperative bleeding and transfusion     remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown.     The investigators conducted a prospective study in order to examine the incidence, and risk     factors associated with peroperative bleeding and transfusion.   "
74447|NCT02311296|"     Ventilator associated pneumonia (VAP) is common problem among ICU patients and major source     of infection among patients receiving mechanical ventilation. Patients on mechanical     ventilation accumulate secretion leading to aspiration of infected secretions. Using new     generation endotracheal tube (Hi-Lo tube) can reduce the incidence of VAP.   "
74448|NCT02311283|"     The purpose of this study is to determine if patients participating in The Longitudinal     Study of Urea Cycle Disorders are different than participants in the Urea Cycles Disorders     Consortium (UCDC) Rare Diseases Clinical Research Network (RDCRN) Contact Registry and to     determine if patients are a good source of medical information.   "
74453|NCT02311218|"     In February 2013, 44 healthy adults was recruited and randomized to daily intake of lozenges     with or without Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks. The effect     of these Lactobacillus reuteri strains on the oral microbial composition was monitored     before, after 4, 8 and 12 weeks and after 1 and 6 months after exposure was completed. For     this purpose saliva and tooth plaque was collected. Of 44 included subjects, 41 completed the     study. The used Lactobacillus reuteri containing lozenges are commercially available and     identical placebo lozenges was obtained from the manufacturer. The study product was well     tolerated with no observed side effects. Compliance was excellent.      The investigators' primary outcome was to determine whether daily intake of Lactobacillus     reuteri strains DSM 17938 and PTA 5289 for 12 weeks alters the tooth colonizing bacterial     plaque composition determined by a multiplex sequencing technique. Effects are put in     relation to general knowledge on bacterial profiles associated with risk to develop dental     caries and periodontitis.   "
74454|NCT02311205|"     This study is a phase II, prospective, open-label, single arm, single center study of the     efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and     sorafenib in patients with hepatocellular carcinoma and extrahepatic metastasis. All of the     55 patients with hepatocellular carcinoma and newly diagnosed extrahepatic (lung, bone, lymph     node, adrenal gland) metastasis will be included.      On demand conventional TACE will be performed in all the patients after enrollment and can be     continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be     started 3-7 days after the first and each subsequent TACE and stopped one day before next     TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening     by clinical decision. Repeated on-demand TACE and sorafenib should continue until the     criteria for treatment discontinuation are met. After initiation of sorafenib combination     treatment, patients will be seen and will perform routine examination at week 4 and, after     then routine examination will be followed every 6 ± 2 weeks.   "
74455|NCT02311192|"     This study is aimed at creation and validation of a vitreous haze scoring system using     ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and     quantification of inflammation will be done to create the scoring scale.   "
74456|NCT02311179|"     This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the     fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type     Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The     surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be     compared with an identical cup without hydroxyapatite.   "
74457|NCT02311166|"     Introduction: The lack of congruence between the acetabulum and femoral head in hip dysplasia     compromise the passive stability of the hip joint resulting in increased stress on the     acetabular labrum, joint capsule and the muscles acting close to the hip joint. Soft tissue     injury is present in hip dysplasia, and pathology of the iliopsoas muscle has been found in     18-50%. To our knowledge, no studies have systematically examined the prevalence of soft     tissue pathology in hip dysplasia.      The overall aim of this research project is to examine soft tissue pathology in 100 patients     with hip dysplasia prior to and one year after Periacetabular osteotomy (PAO).      Methods: Soft tissue pathology will be examined in a prospective cohort study on 100 patients     with hip dysplasia prior to and one year after surgery. Pathology will be examined using     ultrasonography and the Clinical Entities Approach that focus on pathology of the iliopsoas,     adductors, rectus abdominis, gluteus medius and hamstrings. Furthermore, hip muscle strength     is tested with a dynamometer, hip related health is measured with the Copenhagen Hip and     Groin Outcome Score (HAGOS) and physical activity is measured with triaxial accelerometers     during a period of 7 days.      Perspective: Is it possible to demonstrate pathology of the hip muscles and tendons applying     clinical tests, muscle strength tests, and ultrasonography, as it has been found in     sports-active people with groin pain, it will make sense to plan and test a specific training     program focusing on the pathological soft tissue pathology.   "
74458|NCT02311153|"     Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when     delivering general anesthesia to patients during a variety of operative procedures. LMA's     have been studied in a wide range of otolaryngologic procedures, and are generally safe and     accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate     the safety and efficacy of LMA for airway management during sinonasal surgery by directly     comparing them to endotracheal intubation in a prospective randomized single‐blind study.   "
74459|NCT02311140|"     The aim of the proposed trial in assessment of effects of Kalydeco™ treatment on sinonasal     involvement in CF patients with at least one mutation of G551D receiving a new therapy with     the CFTR potentiator. The focus will be given on changes in epithelial lining fluid     inflammatory markers from CF upper airways sampled by nasal lavage.      The program is subdivided into a part A assessing inflammatory markers in NL and sinonasal     symptoms longitudinally from pre-treatment to months with the new therapy.      Part B will only be performed in a smaller subgroup and assess inflammatory markers in NL     every second day in the first month of treatment and then every week until the end of month 3     with Kalydeco™ therapy.   "
74460|NCT02311127|"     Peripherally inserted central catheters (PICCs ) are used for the administration of     intravenous fluids and for blood sampling. PICCs may remain in place for weeks to months and     are safeguarded from migration or accidental dislodgement by securement devices. Different     types of these devices are available. StatLock® (C.R. Bard) is a stabilization device with an     adhesive anchor pad. The catheter wings of the PICC must be placed over the posts then the     system is closed with gull-wings . StatLock® has to be changed weekly. Healthcare providers     have to pay attention to prevent accidental catheter dislodgement during the renewal     procedure. SecurAcath® (Interrad Medical) is a new securement device to the European market.     The device uses a small subcutaneous anchor to secure the PICC. One of the advantages     compared to adhesive stabilization devices, is a reduction in maintenance time by simplifying     dressing changes and subsequently staff time. It is described that nurses report that care is     left undone due to low staffing levels. Therefore, investigation of nursing time savings with     the support of technology is imperative. SecurAcath® remains in place for life of the PICC     and therefore has the potential to reduce the time for dressing change as there is no need     for weekly device change. The objective of this study is to measure nursing time for dressing     change and explore inserting and removal issues and patient experiences.   "
74461|NCT02311114|"     This study will evaluate the Telehomecare (THC) Program offered to patients with heart     failure or chronic obstructive pulmonary disease across the Central West, Toronto Central and     North East Local Health Integration Networks in Ontario. It will explore the opinions and     experiences of patients, providers, technicians and administrators involved with THC Program     in order to provide stakeholders with information about the processes and organizational     factors impacting the program's adoption, the experiences of its participants, impact on     patient outcomes, costs to the health-care system and who is benefiting the most from     participating. These factors will be determined using semi-structured interviews, surveys,     and observation of practices of everyone involved with THC. The study will also evaluate     patient data to determine changes in patients' utilization of healthcare services.   "
74462|NCT02311101|"     The study aims to establish the safety and toxicity of a combined intravesical mitomycin C     with BCG for patients with bladder cancer.   "
74463|NCT02311088|"     Ticagrelor treatment is associated with increased rates of dyspnea, where previous studies     have implied a possible role of adenosine. The purpose of this study is to determine if the     caffeine-antagonist is effective in reducing dyspnea related to ticagrelor.   "
74464|NCT02311075|"     Endothelial dysfunction of conduit arteries plays an important role in the development of     cardiovascular complications associated with type 2 diabetes. In order to propose targeted     therapeutic approaches, this study aim to determine the mechanisms involved in endothelial     dysfunction of conduit arteries in these patients.   "
74465|NCT02311062|"     This investigation is aimed to examine the effects of two different exercise-oriented     protocols on the knee torque-angle relationship of the knee flexors.      Thirty two young soccer players were be randomly assigned to three groups:     hamstring-eccentric (ECC, n=11), unstable-squatting (UNS, n=11) or control (C, n=10). The ECC     and UNS groups performed eighteen sessions over 6 weeks of an injury prevention protocol,     using only 3 hamstring-eccentric or unstable-squatting exercises. The angle-torque     relationship was measured before and after the training intervention. Voluntary isometric     torque was recorded at six test angles, with participants prone (35º-100º; 0º on full     extension).   "
74466|NCT02311049|"     External beam radiotherapy (RT) is one of the standard curative treatment options for     patients with prostate cancer (PC). Several randomised trials have shown excellent long-term     biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of     delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks.     The sensitivity of different tissues to fractionation changes can be quantified through the     alpha/beta ratio in the linear-quadratic model. Dose-response analysis of PC patients treated     with both external beam RT and brachytherapy has led to the hypothesis that the alpha/beta     ratio of PC is lower than for most other tumors and approaches a value characteristic of late     responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the alpha/beta     ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain     high bioequivalent tumor doses, shorten overall treatment time and decrease late     toxicities.The advantages in terms of patient convenience and treatment cost are obvious.     There is level I evidence that shows that hypofractionated radiotherapy schedules have at     least equivalent biochemical outcome with only a small increase in acute but not late     toxicity when compared to conventional fractionation RT schedules.      Results on different hypofractionation schedules have been reported, however the optimal     hypofractionation is not clear so far. In this randomised trial we would like to compare 2     different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25     fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late     toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be     registrated and compared. The study will be performed in 2 stages. For stage 1, sample size     was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel     (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design.     A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per     group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI     complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160     patients were included in stage 1. Sample size for stage 2 was calculated analogously     allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI     complications with an expected rate of 25%. When including 155 patients per group (310 in     total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients     out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The     sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10%     allowance for dropout.   "
74467|NCT02311036|"     The purpose of the study is to investigate the effects and outcome predictors on functional     recovery after comprehensive rehabilitation for post-acute care -cerebrovascular diseases.   "
74468|NCT02311023|"     This is an open trial of intermittent fasting in a group of patients with refractory     seizures. Patients will continue on the diet for 6 months to assess the impact of the diet on     seizure frequency.   "
74469|NCT02311010|"     To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after     kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of     the genetic Cyp 450 3A5 polymorphism of the recipient.      The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is     reached.   "
74470|NCT02310997|"     This trial is looking at using umbilical cord blood from unrelated donors after high dose     chemotherapy. It is for people who have cancer of the bone marrow or lymphatic system     including leukaemia and lymphoma, or a blood disorder called myelodysplastic syndrome (MDS).      The trial is for babies over 4 weeks old, children, and adults up to the age of 45.   "
74471|NCT02310984|"     This project which is fully funded by the European Union FP7 Program is designed to pull     together all the information we obtain from scans and x-rays to design a personalised 3-D     digital model of each patient, their anatomy and disease. We can then use this as follows: as     (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision     support tool to communicate the available treatment options to the patient and facilitate     shared decision making and provision of personalised care and (iii) to enable standardised     objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to     demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer     patients and assess the impact on their care and quality of life.   "
74472|NCT02310971|"     The purpose of this study is to assess the safety and tolerability of CVac, an     investigational cell therapy, in patients with resected stage I or II adenocarcinoma of the     pancreas who have completed surgery with or without front-line chemotherapy or radiation     therapy.      After confirmation of non-measurable disease patients will undergo leukapheresis for     manufacture of the study agent.   "
74473|NCT02310958|"     The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia     repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will     be based on a review of hospital records and a questionnaire answered by families. Patient     demographics (age, gender), affected side, type and duration of laparoscopic intervention,     and outcome parameters (hernia recurrence, post-operative complications, eg. infections,     length and type of postoperative pain medication, and length of the postoperative hospital     stay) will be analysed.   "
74474|NCT02310945|"     Pain is the dominant symptom of knee osteoarthritis and recent evidence suggests factors     outside of local joint pathology, such as pain sensitization, can contribute significantly to     the pain experience. It is unknown how pain sensitization influences outcomes from commonly     employed interventions such as physiotherapy.      The aims of this study are, firstly to identify people with knee OA who display signs and     symptoms associated with pain sensitization using clinical tools and quantitative sensory     testing. Secondly, we will investigate if indications of pain sensitization at baseline are     associated with poor outcome following physiotherapy.      Methods and analysis:      This is a multi-centre prospective cohort study with 140 participants. Eligible patients with     moderate/severe symptomatic knee osteoarthritis will be identified at hospital outpatient     clinics. A baseline assessment will provide a comprehensive description of the somatosensory     characteristics of each participant by means of clinical examination, quantitative sensory     testing and validated questionnaires measuring pain and functional capacity. Participants     will then undergo physiotherapy treatment, in line with current clinical guidelines.     Follow-up post physiotherapy treatment (estimated to be at 3 months) will assess pain,     disability (sub-scales of Western Ontario and McMasters University Score Osteoarthritis     Index) and participants' global rating of change. These primary outcome measures will     dichotomise participants into treatment 'responders' and 'non-responders' according to the     Osteoarthritis Research Society International (OARSI) treatment responder criteria.      For data analysis results from pressure pain thresholds, temporal summation and conditioned     pain modulation will create a composite score of pain sensitization. Logistic regression will     explore the relationship between response to physiotherapy and pain sensitization at baseline     while accounting for various cofounders.   "
74475|NCT02310932|"     This cluster Randomized Controlled Trial was designed to implement and evaluate the effects     of a multi-level intervention designed to integrate mental health treatment into rural     primary health clinics in South India using a collaborative care model.   "
74476|NCT02310919|"     This is a randomized, double-blind, single center clinical trial study to compare the oocyte     maturity, embryo development, and risk of ovarian hyperstimulation syndrome (OHSS) after     receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a     lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women     undergoing in vitro fertilization (IVF).   "
74477|NCT02310906|"     This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability,     efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with     deletions amenable to exon 53 skipping.   "
74478|NCT02310893|"     Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL),     prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits     communities by reducing transmission to others. Mere availability of ART and care, however,     is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the     health care provider, regular monitoring and regular delivery of medications, - known as     retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons,     especially low-income minorities are out of care. Innovative interventions are therefore     urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as     well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will     assess outcomes of the following interventions in comparison to usual care: 1) contingency     management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that     integrates both CM and PN (CA) which the investigators hypothesize to be most effective in     improving HIV clinical outcomes.   "
74479|NCT02310880|"     Low vision patients have difficulty acquiring sufficient visual information in a timely     manner for the purpose of performing challenging daily tasks, such as traveling independently     and safely through busy streets. The advance of virtual reality techniques has provided a     potential platform for training low vision patients to use their remaining vision more     efficiently, but the key issue is always whether the patient's visual experiences in a     virtual world can be transferred to the real world. The proposed study is designed to provide     definite answer to this question.   "
74480|NCT02310867|"     The purpose of this study is to determine the safety and efficacy of hand transplantation as     a treatment for patients with loss of limb below the elbow, The study will focus on patients     who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in     activities of daily living at 18 months following transplantation measured by a quantitative     functional test.      Study activities include several study visits over 18 months and include; demographics,     medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone     density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have     loss of limb will be included in study evaluation.      Risks of the study include risk of rejection and infection after being transplanted.     Additional risk are associated with procedures that include blood draws, biopsies, x-rays,     and potential loss of confidentiality. All patient data will be kept electronically and in     accordance with the requirements of Duke University. In addition to the experimental data,     this database includes recipient and donor demographics and transplant relevant medical     history, range of motion, sensation, and immunosuppressive medications. Data will be recorded     and reported in accordance with the standards required by the United Network for Organ     Sharing (UNOS).   "
74481|NCT02310854|"     To investigate the hypothesis that suture repair of a ruptured vkb, combined with a dynamic     intraligamentary stabilization and microfracture of the femoral notch, results in at least     equal effectiveness compared with an ACL reconstruction using autologous hamstring in terms     of functional recovery one year postoperatively in terms of a patient self-reported outcome     related to be able to conduct daily and sporting activities. Secondary, the evaluation of     clinical outcomes, self-reported by the patient outcomes, osteoarthritis, rehabilitation time     required for return to daily and sporting activities and levels of sporting activity which     has returned in patients with status after an ACL rupture and suture repair augmented with a     dynamic intraligamentary microfracture and stabilization of the femoral notch in comparison     with an anterior cruciate ligament reconstruction with the ipsilateral hamstring graft.   "
74482|NCT02310841|"     This pilot study investigates the feasibility of novel control strategies for actuated     transfemoral prostheses. Several parameters from gait analysis (including motion-capture and     ground reaction force measurements) are analyzed. The subjective perception of prosthetic     functionality is captured with a questionnaire.   "
74483|NCT02310828|"     The purpose of this study is to validate the novel hypothesis that daily use of L-cysteine     (Acetium® capsules) is an effective means to decrease the frequency of (or completely abort)     the attacks of cluster headache.   "
74484|NCT02310815|"     This is a prospective multicenter observational post-approval registry study that will     collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events     for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a     broad group of physicians under commercial use conditions.   "
74488|NCT02310763|"     This is a Phase 2 randomized, 2-period, double-blind, placebo-controlled, multiple ascending     dose study to evaluate the safety, efficacy, PK and PD of PF-06252616 administered to     ambulatory boys diagnosed with Duchenne Muscular Dystrophy. Three intravenous (IV) dose     levels will be investigated in a within subject dose escalating fashion. Subjects will be     randomly assigned to 1 of 3 sequence groups for approximately 96 weeks (2 periods of 48 weeks     each). In period 1, two of the sequence groups will receive PF-06252616 and one sequence     group will receive placebo. In period 2, the placebo group will switch to PF-06252616 and the     two remaining sequence groups will either receive placebo or PF-06252616. Efficacy will be     based on an observed mean change from baseline on function (4 stair climb) of PF-06252616 as     compared to the placebo at the end of period 1. Period 2 provides an opportunity to evaluate     PK. Subjects will receive monthly IV infused doses of either PF-06252616 or placebo and will     undergo safety evaluations (Laboratory, cardiac monitoring, physical exams, x-ray, MRI),     functional evaluations (pulmonary function testing, 4 stair climb, range of motion, strength     testing, Northstar Ambulatory Assessment, upper limb functional testing and the six minute     walk test), pharmacokinetic testing and pharmacodynamic testing to evaluate changes in muscle     volume (MRI).   "
74489|NCT02310750|"     The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when     administered to humans. A secondary purpose is to assess what the body does to PF-06700841     and to assess what PF-06700841 does to the body when given as single and multiple doses. The     pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and     solution/suspension forms).   "
74490|NCT02310737|"     The purpose of this study is to compare sharp and blunt fascial entry during caesarean     section.   "
74491|NCT02310724|"     The primary objective of T2P2 is to track the progression of T2D and related comorbidities     and complications in the TODAY cohort as they transition to young adulthood. We hypothesize     that:        -  Youth-onset type 2 diabetes (T2D) will progress rapidly and result in high rates of          diabetes-related medical complications and comorbidities.        -  The rapid rate of progression is related to increased insulin resistance characteristic          of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic          factors, and obesity itself.   "
74492|NCT02310711|"     The proposed study is a single-center, prospective, pilot, observation study to tabulate and     measure the changes that occur during treatment and healing for breast conserving therapy     (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of     breast lumpectomy and healing in order to identify targets for improving BCT. The study will     be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer     undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving     their BCT surgery and will be followed for six months after the BCT surgery. A total of 6     visits (not including the surgery) are planned.   "
74493|NCT02310698|"     Breast tumors are often detected on mammography but may be harder to see in women with dense     breasts. This is why screening breast ultrasound is sometimes used as another test in women     with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen     on regular mammography.      Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is     essentially a routine digital mammogram performed after iodine dye (the same that is used     with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been     shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this     study is to compare whether CEDM or screening breast ultrasound is better at detecting     cancer. Both will be done in this study and compared to one another.   "
74494|NCT02310685|"     RATIONALE Controlling cardiovascular risk factors has been proven to be effective in     prevention and management of cardiovascular disease (CVD). Nonetheless, significant treatment     gaps have been demonstrated repeatedly in numerous surveys. A recent study of Canadian adults     filling prescriptions for hypertension or dyslipidemia demonstrated that the majority     remained overweight and sedentary despite being at risk of developing CVD. Medication     adherence has been shown to be poor with up to 50% of patients stopping therapy after one     year.      Patient-centred care can lead to improved clinical management and patient satisfaction.     Adherence with prescribed therapy can also be improved if individuals understand the     importance of their risk factors, are aware of their overall health status and participate in     decision making surrounding pharmacotherapy and lifestyle changes.      Community pharmacists are frontline healthcare professionals who can identify patients at     risk of CVD, assess their adherence with recommended lifestyle behaviours or drug therapy and     engage them in shared decision making surrounding health promotion strategies. Local     pharmacies could effectively become readily accessible community health centres nationwide.      Research Objectives. The primary objective is to evaluate, in a randomized clinical trial,     the impact of a community pharmacy intervention to improve the management of cardiovascular     risk factors vs a basic e-health education program. The intervention will include a     cardiovascular or cardiometabolic risk assessment providing the individual with their     Cardiovascular or Cardiometabolic Age. Individuals at increased risk of CVD and/or with     modifiable risk factors will also be offered a one year subscription to a multidisciplinary,     pharmacy based, e-health promotion program to improve management of CVD risk factors such as     weight loss and increased physical activity and track their progress in managing their risk     factors and reducing their Cardiovascular or cardiometabolic Age. Changes in CVD risk     factors, Cardiovascular/cardiometabolic Age, and uptake or adherence to medications and     lifestyle changes will be examined 3 months, 6 months and one year post intervention.      Study Hypothesis. Investigators hypothesize that engaging patients in a discussion of their     Cardiovascular or Cardiometabolic Age and management of their risk factors will result in     improved healthy lifestyle habits moreover increased physical activity and weight loss.   "
74495|NCT02310672|"     The study evaluates the effect of macitentan on right ventricular and hemodynamic properties     in patients with symptomatic pulmonary arterial hypertension. Patients are treated with     macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and     Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and     Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each     patient can participate in no sub-study or in one sub-study. The sub-studies are: (1)     metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the     RHC); (3) Echo sub-study.   "
74496|NCT02310659|"     Coronary artery calcification (CAC) is a pandemic condition in elderly patients with coronary     artery disease (CAD) and associated with worse prognosis. Although available data shows     association between testosterone levels in men and CAD, the association between testosterone     and CAC in old-aged male patients with CAD remains unknown. In this study, the relationship     of serum testosterone levels with CAC score in elderly male patients with CAD was evaluated.   "
74497|NCT02310646|"     To gather insight on how product attributes affect usability by investigating the factors     that are thought to influence patient preference to topical anti-psoriatic treatments.   "
74722|NCT02307708|"     The purpose of the study is to compare the treatment by wearing shoes inclined at     kinesitherapy because it is the first treatment offered by primary care physicians in chronic     Achilles tendinopathy.   "
74498|NCT02310633|"     Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation     Research & Development (RR&D) and represents a critically important public health problem     facing the Veteran population. Developing efficacious treatments for persistent memory     deficits seen in this population is a key step in reducing the impact that such problems have     in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite     heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple     alternative treatments individually matched to the Veteran's key deficits, and by research     that seeks to understand the cognitive and neural basis of treatment-related change over     time. The results of this approach may aid clinical decision making and assignment of     patients to rehabilitative treatments most likely to improve memory capacity and functional     outcome.   "
74499|NCT02310620|"     The aim of the study is to show that regular playing with the logic games developed in the     framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent     mild cognitive impairment (MCI) and dementia.      The secondary aim of the study is to find correlations between the results of the games and     the standard assessments for dementia and MCI screening such as the Rey Verbal Learning Test.   "
74500|NCT02310607|"     This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence     non-invasively from the intact oral mucosa. Zinc protoporphyrin-IX is an established     indicator of iron deficiency. The prototype device is used to measure the erythrocyte zinc     protoporphyrin-IX/heme ratio for women after delivery, a study group chosen because of an     elevated risk of iron deficiency. The results from the non-invasive measurements are compared     to reference measurements of the erythrocyte zinc protoporphyrin-IX/heme ratio from residual     blood samples from the same patients and to other indicators of iron status, including     hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin     receptor.      Funding Source - Nestec Ltd.   "
74501|NCT02310594|"     This research trial studies the effect of radiation therapy on tumor immunity. Standard     radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation     therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this     response is often ineffective in shrinking tumor tissue. Collecting samples of blood from     patients before, during, and after radiation therapy to study in the laboratory may help     doctors learn more about the effects of radiation therapy on anti-tumor response.   "
74502|NCT02310581|"     This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group,     placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of     Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants     with moderate to severe postoperative pain after bunionectomy. The study will comprise 4     periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up     Period.      Participants will be admitted to the study site on the morning of the scheduled surgery, will     remain at the study site until postoperative Day 3 (a total of 3 nights at the study site),     and will return for the Follow-up Visit 5 to 9 days after surgery.   "
74503|NCT02310568|"     This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of     sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment     periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton     Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of     PF-06372865 compared to placebo.   "
74504|NCT02310555|"     The aim of this study is to compare clinical and laboratory findings of three surgical     techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI>     30).   "
74505|NCT02310542|"     A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not     cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove     those substances. Albumin dialysis with recirculation (MARS) is the most used system but     required specific system and expert environment. Alternative system without recirculation     (SPAD) is less expensive and can be realised in critical care services trained to extrarenal     epuration. The primary objective of this study is to compare biological and clinical     efficacy, pulsatility index of middle cerebral artery modification and tolerance of both     systems.      This is a prospective, open, cross-over comparative study of two albumin dialysis system.     Each patient will receive the two systems in an randomly assessed order. Patients are divided     up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and >400µmol/L).   "
74506|NCT02310529|"     Depression related to pregnancy frequently presents postpartum depression, which has     deteriorating and lasting negative effects, not only on infant and child well being but also     on mother's and father's mental health (Nancy K et al 2009). It is therefore important to     introduce interventions aiming to improve mental health of mothers that could minimize the     risk of diseases, and have positive effect child's on physical and psychological     developmental wellbeing.      Therefore, this project has been designed to assess the effectiveness of Interpersonal     Psychotherapy for Postnatal Depression in Pakistan.   "
74516|NCT02310399|"     This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be     conducted as a repeated-measures, single subject experiment in order to accommodate the known     variability in cochlear implant clinical results. Data obtained in the course of this study     will be compared with the existing published outcome data from children with normal hearing     and with cochlear implants (CIs). These comparisons may provide additional useful information     about the progress of ABI subjects' performance over time. Also, this may allow the results     of the current study to be utilized to design future pivotal studies of the device in the     pediatric population.   "
74517|NCT02310386|"     Fibromyalgia is one the most common causes of chronic pain syndromes in women. It causes     considerable costs in primary health care setting as well as specialized medical care     sector.Electrotherapy and exercise therapy has shown to have short-term pain relieving     effects in randomized controlled trials (RCT) among fibromyalgia patients. However, there is     sparse knowledge about the effects of long-term RCTs in the treatment of pain in     fibromyalgia, as there are no publications about cost-effectiveness analysis of such     treatments.      The aim of this study is to investigate whether the BEMER electromagnetic field therapy     device has beneficial long-term effects in the treatment of pain, and whether it improves     fibromyalgia patients' quality of life. In addition, this study investigates whether the     BEMER device treatment is cost-effective in the treatment of fibromyalgia patients.   "
74507|NCT02310516|"     The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy     surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor     functions, languages and cognitive to better respect them. Indeed, the interindividual     anatomo-functional variations, the lack of specificity of functional explorations     radiological magnetic or nuclear, as well as the reorganization of the areas involved in     these functions (mechanisms of brain plasticity) in epileptic patients or patients with     cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an     analysis and a precise real-time identification of areas and networks involved in these     functions through a direct electrical stimulation (inhibitory or activatory). Thus, this     surgical technique has become a gold standard in surgery of brain lesions located in     functional areas.      However, although the brain awake surgery has been practiced since many years, the     confidentiality of these informations until recent years explains probably that very little     data to be available on the personal experience of this procedure by patients. Studies that     have analyzed the perception of the patient or the satisfaction of the patient after surgery     in awake conditions were retrospective and included few patients. The investigators     experience of lived of this surgery that the investigators have developed in the     investigators team since over four years is that on the whole awake surgery is well tolerated     if adequate explanations are provided preoperatively and if a minimum of preoperative     precautions are observed.      Thus, the investigators have decided to develop a preoperative device that could improve     personal experience and well-being of patients undergoing this surgical approach.   "
74508|NCT02310503|"     REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs     surgery, and patient, tumor and technique factors related to adverse events and tumor     recurrence.      REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in     participating centers. All consecutive patients are included. The only exclusion criteria are     being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by     common clinical practice, but at least once a year for the study period.   "
74509|NCT02310490|"     Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter     clinical study of DermaVeil (Injectable poly-l-lactic acid) compared to SCULPTRA in the     treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive     DermaVeil and SCULPTRA on either the right or left side of the face.   "
74510|NCT02310477|"     This is a largest cohort study aimed to estimate the overall survival of patients been     treated with regorafenib for metastatic colorectal cancer (mCRC) within the frame of a french     compassionate program.   "
74511|NCT02310464|"     The primary purpose of the clinical trial is to investigate safety and tolerability of     escalating doses of OBI-833/OBI-821 in subjects with metastatic incurable solid tumors, such     as gastric, lung,colorectal or breast cancer. Meanwhile, the tumor response and humoral     immune responses, i.e.,anti-Globo H IgG and IgM production following administration of     OBI-833/OBI-821 will be assessed as the secondary objective of this study.   "
74512|NCT02310451|"     Recent progresses have been made in the treatment of metastatic melanoma, nevertheless     improved patient survival is still limited because of primary resistance and relapses. It is     therefore important to continue to understand the molecular mechanisms involved in melanoma     development and progression to improve the management of patients.      Drugs such as the alkylating agents (temozolomide and fotemustine) or vemurafenib trigger     senescence-like phenotypes in melanoma cells. It is now known that senescent cells secrete     some factors that exert a pro-tumoral role but the potential existence and the role of     insoluble factors remain undetermined.      Preliminary results from the investigators laboratory indicate the presence in the senescent     secretome of exosomes; microvesicles involved in intercellular communication,     immunomodulatory functions, and tumorigenesis. Several studies showed that these vesicles     shape the tumor microenvironment and contribute to the migration of cancer cells.      Their interest in oncology as a prognostic factor and marker of therapeutic response is     increasing.      Thus, our project aims to study the effect of exosomes produced by senescent melanoma cells     in the development and progression of melanoma in vitro and in vivo using cell cultures and     animal models.      In addition, the investigator propose a pilot study whose objective is to determine the     effect of vemurafenib on nanovesicles produced by patients with advanced unresectable or     metastatic melanoma.      The investigator hope to show that exosomes participate in the process of drug resistance and     relapse, with the goal of developing (with the exosomes study) theranostic tools for     personalized care in patients.   "
74513|NCT02310438|"     Impairment of arm function is more common than lower limb impairment in stroke patients and     is also more resistant to treatment. Several clinical trials with stroke patients have     produced statistically significant gains in upper limb function when using instrumental     playing and treatments where rhythm supports the priming and timing of movements. Based on     the positive results from controlled and non-controlled trials, the Cochrane review of music     therapy for acquired brain injury (Bradt, et al., 2010) recommends further investigation into     rhythm based techniques to treat hemiparesis in stroke patients, and that future studies need     to examine the relationship between the frequency and duration of interventions and treatment     effects.      The aim of this study is to examine whether or not a thirty minute, twice weekly, six week,     home music therapy treatment, playing set musical patterns on instruments to music is     feasible to deliver, and will lead to improved coordination, dexterity and activities of     daily living in hemiparetic stroke patients.      Twelve patients will be recruited from Cambridgeshire Community Services NHS trust (CCS) who     are between one month and two years post stroke with hemiparesis. Participants will have     completed and been discharged from community rehabilitation for their upper limb and not be     receiving any other treatment for arm function. They will be randomised into two groups:     treatment (for immediate treatment following discharge from community rehab) and waiting list     (beginning 9 weeks after baseline measure). Participants will be assessed at the beginning     and end of treatment (just before starting and just after completing 6 weeks of treatment) by     one of two experienced community occupational therapists under contract with CCS, who are     also experienced in working with stroke patients and who will be blind to the experiment. The     other three measures will be conducted by the chief investigator. The assessment tools will     be the Action Research Arm Test (ARAT) and nine hole peg test (9HPT). There will also be a     pre and post treatment semi-structured interview for each participant, which will be     conducted by the chief investigator. ARAT and 9HPT assessments will be administered to all     participants at the same time points: baseline and then at week 6, 9, 15 and 18. Data will be     analysed to determine if the treatment is effective compared to no treatment (wait list)     following community discharge, and whether earlier intervention (treatment group) yields     better results for participants, all of whom will eventually receive treatment.   "
74530|NCT02310217|"     The relationship among hypertension, aging and cognitive decline is complex and not     completely understood. Purpose of this project will be evaluating early markers of cognitive     deterioration in patients with arterial hypertension. In particular, this cross-sectional     observational study will be articulated in three phases:        1. Neuropsychological evaluation of general cognitive abilities        2. Identification and measurement of specific biomarker levels        3. Correlation among hypertension, cognitive abilities and biomarkers.   "
74518|NCT02310373|"     This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones)     smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking     is known to transiently increase blood pressure and heart rate while decreasing heart rate     variability suggesting - but not proving - sympathetic mediation. The contribution of     nicotine to these effects is unknown. Here the investigators will directly measure the acute     effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography     (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.   "
74519|NCT02310360|"     The purpose of this study is to investigate whether a combination of taste probes and     food-related cues can induce dopamine release in striatal and extra-striatal brain regions in     healthy subjects.   "
74520|NCT02310347|"     The purpose of this study is to examine the influence of a medicinal cannabinoid agonist     versus placebo on behavioural and gut peptide responses to food images and food intake.   "
74521|NCT02310334|"     The objectives of this study are to demonstrate that real time physiological status     monitoring and the use of optimization techniques during exercise can have a positive impact     on physiological status, and to collect metabolic flexibility profiles of young fit adults     during rest and exercise.   "
74522|NCT02310321|"     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended     expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction     chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly     Diagnosed Acute Myeloid Leukemia (AML). Safety and tolerability of ASP2215 will also be     evaluated. This study will also characterize the pharmacokinetic (PK) parameters of ASP2215     concomitant with induction and consolidation chemotherapy as well as evaluate the PK     parameters of cytarabine concomitant with ASP2215.   "
74523|NCT02310308|"     The effect of chewing gums containing MBE and xylitol on different variables related to     caries and gingivitis in a sample of adult volunteers with a high risk for caries will be     evaluated. The main result of that double-blind randomized controlled interventional trial     will be that chewing gum containing MBE was more effective in reducing plaque acidogenicity,     salivary mutans streptococci concentration and gingival bleeding compared to a xylitol and     sugar-free chewing gum.   "
74524|NCT02310295|"     Purpose: To compare the effects of macular photocoagulation with or without intravitreal     bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME).     Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive     either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16)     or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected     visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were     performed at baseline and monthly for 12 months.   "
74525|NCT02310282|"     Observational prospective single-center study on the discriminatory value of the Unassisted     TeleStroke Scale for differentiation between patients with lacunar stroke and those with     other acute stroke syndromes.   "
74526|NCT02310269|"     This is a non-interventional, multinational, multi-center post-marketing study, to further     document the safety and efficacy of pasireotide s.c. administered in routine clinical     practice in patients with Cushing's disease. Patients with Cushing's disease and treated with     pasireotide s.c. alone and in combination with other therapies will be monitored. For this     study, each enrolled patient will be followed up for 3 years after enrollment. Patients who     permanently discontinue pasireotide s.c. prior to completing the 3-year observation period     will be followed up for 3 months after the last dose of pasireotide s.c.   "
74527|NCT02310256|"     The aim of the study is to evaluate whether walking capacity in patients with intermittent     claudication is improved more by home-based 5+ exercise training than by current     recommendations of daily walking. The study will elucidate if such a potential effect is     dependent on changes in mitochondrial respiratory capacity, blood flow or both.   "
74528|NCT02310243|"     Diagnosis: Acute myeloid leukemia; Acute lymphoblastic leukemia Age ≥ 18 years, no upper age     limit Study drug: Palbociclib Phase Ib/IIa, open-label        -  Phase Ib: Based on previous experience with 125 mg palbociclib once daily for 21 days          followed by 7 days of rest in patients with breast cancer, liposarcoma, non-small cell          lung cancer, hepatocellular carcinoma, ovarian cancer, mantle-cell lymphoma, and          glioblastoma, this regimen will be chosen for the first dose to be evaluated in the          phase Ib. Based on a 3 + 3 modified Fibonacci design, the tolerable dose of palbociclib          for the phase IIa is defined.        -  Phase IIa: single-agent palbociclib using the tolerable dose defined in the phase Ib          part of the study is administered once daily for 21 days followed by 7 days of rest.          Based on the optimal two-stage design of Simon, 21 patients are treated in the first          stage. If results are positive, 29 additional patients will be recruited into the second          stage of the study. An efficacy of the investigational therapy will be rejected in the          first stage of 21 treated patients if two or less patients achieve complete remission          (CR), CR with incomplete blood count recovery (CRi), partial remission (PR), or          anti-leukemic effect (ALE). If three or more patients achieve CR, CRi, PR, or ALE during          this first stage, the trial is intended to be continued in the second stage with a total          sample size of 50 patients.      Start of recruitment: July 2015 End of recruitment: July 2017 End of study (last patient     out): July 2018 The treatment duration of an individual patient is estimated to be 2-6     months, but may be unlimited in patients with sustained response (case-by-case decision).      Observation time per patient after entry into the study (incl. treatment) is at least 12     months.   "
74529|NCT02310230|"     Purpose: To assess the utility of a new medical device that monitors a patient's breathing     during medical procedures in which a patient is sedated, but not mechanically ventilated. In     minor procedures, such as endoscopy (where the doctor examines a patient's digestive tract by     a TV camera inserted through the mouth), patients do not require general anesthesia, in which     a machine would take over their breathing while they are unconscious for surgery. However,     during endoscopic procedures it is sometimes difficult for the anesthesiologist to monitor     the patient's breathing—specifically, to monitor changes in breathing patterns and the     adequacy of breathing. In endoscopy procedures, the room is darkened, and the patient's mouth     is generally occupied by the endoscope. While the anesthesiologist can listen to the     patient's breathing sounds with a stethoscope, this type of monitoring can only be done     periodically, and there is limited ability to gauge the adequacy of ventilation. This study     will use the ExSpiron Respiratory Volume Monitor (RVM), which measures non-invasive minute     ventilation (MV), tidal volume (TV) and respiratory rate (RR), in patients undergoing an     endoscopic procedure to provide additional information regarding the effects of clinical     interventions such as drug administrations or airway maneuvers on the patient's respiratory     status.      For patients who give informed consent, study participation means that they will have a     PadSet consisting of 3 electrodes applied to the chest. Another component, a nasal cannula (a     thin clear plastic tube that goes under the nose) will give patients supplemental oxygen, and     is standard of care for endoscopy at UVM Medical Center. Patients will then be asked to     breathe in and out of a portable spirometer (breath meter) for 30 seconds up to five times.     This data will be compared to data recorded by the monitor to confirm that the monitor is     recording accurately. The procedure will then go forward in the normal fashion. Patients will     be randomly placed into one of two groups. In the first group during the procedure, the     anesthesiologist will not be able to see the numbers (MV, TV, and RR) displayed screen of the     monitor, so the data will not be used to guide the patient's clinical care. In the second     group, the anesthesiologist will be able to see the RVM measurements of MV, TV, and RR to     evaluate the effect of the interventions. Monitoring for both groups will continue in the     recovery room, until discharge.   "
74534|NCT02310165|"     The purpose of this study is to compare two different methods that are used for inserting the     needle during paracentesis. One method is called the coaxial insertion technique and the     other is called the z-tract technique. Researchers would like to see which method is better     and leads to less problems like oozing from the needle insertion site and pain during the     procedure. Both methods are approved and currently used methods for doing a paracentesis at     the University of Virginia. Which method is used generally depends on physician preference.     There have been no studies done to date that compare these two methods for needle insertion.   "
74535|NCT02310152|"     Childhood anxiety disorders are very common, carry tremendous personal and societal costs,     frequently do not respond adequately to treatment, and involving parents in treatment has so     far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific     mechanisms of change that are not targeted in direct child treatment, and to identify markers     of who is most likely to benefit from parent intervention. This study is an explanatory     clinical trial of a parent based intervention and of cognitive behavioral therapy, and an     investigation of biological and behavioral moderators of treatment response.   "
74536|NCT02310139|"     Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal     disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this     removal is also known as polypectomy.      Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying from     it. Colonoscopy can be challenging due to technical or patient factors. In a small proportion     of patients a complete colonoscopy is unsuccessful. Such patients either get referred to a     tertiary centre with extensive experience in difficult colonoscopy or have an alternative     test such as CT scan. The investigators unit has accumulated significant experience related     to previously failed colonoscopy and anecdotally appears to have a high success rate in     completing the procedure.      The purpose of this project is to describe the investigators technical approach to management     of patients with previously failed colonoscopy. There is no additional intervention and the     project is observational in nature. The investigators will collect data on patient     characteristics, the reason for the failure and what technique was used to overcome the     difficulty. The investigators will also note whether the final outcome of the technique had     any impact on the overall management of the patient.   "
74537|NCT02310126|"     Subjects will evaluate each study lens in a random order. The lenses will be worn in both     eyes for a short period.   "
74538|NCT02310113|"     The aim of the present study was to re-challenge the current data that anaemia in chronically     anaemic haematology patients is not associated with low skeletal muscle StO2, and that the     age of RBCs does not influence tissue responses. The investigators investigated these aspects     using improved technology NIRS devices, for deeper tissue penetration and removal of the     superficial signal from the skin.   "
74539|NCT02310100|"     A prospective, multicenter, interventional study to collect confirmatory evidence on the     safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post     approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using     contact force assisted irrigated radiofrequency ablation.   "
74540|NCT02310087|"     The purpose of the study is to determine whether administration of dietary supplement of     astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo     development in Assisted Reproduction Techniques (ART) procedures.   "
74541|NCT02310074|"     Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex     development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy     and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we     compared the different efficacy and safety of pulsatile GnRH pump therapy with combination     gonadotropin therapy on fertility and sexual development in male patients with IHH.   "
74542|NCT02310061|"     Volume overload is a leading risk factor for death and cardiovascular events in end stage     renal disease patients maintained on chronic dialysis, particularly in those with myocardial     ischemia and heart failure which represent a substantial fraction of this population. Early     identification of volume overload may prevent cardiovascular sequel in these patients but     clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk     and to monitor them over time. On the other hand, however reliable, standard techniques for     measuring extracellular or circulating (blood) volume do not convey information on     fundamental heart function parameters that determine the individual haemodynamic tolerance to     volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling     pressure and LV function.      Extra-vascular lung water is critically dependent on these parameters and represents a proxy     of both, circulating volume and LV filling pressure and function, and may therefore be a     better criterion to identify patients at a higher risk of volume-dependent adverse clinical     outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5     min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung     water by using standard ultrasound (US) machines has been validated in dialysis patients.     Whether systematic measurement of lung water by this technique may translate into better     clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.      The aim of this randomized clinical trial is that of testing a treatment policy guided by     extra-vascular lung water measurements by ultrasound to prevent death, decompensated heart     failure and myocardial infarction as well as progression of Left Ventricular Hypertrophy     (LVH) and LV dysfunction and hospitalization in high risk dialysis patients with myocardial     ischemia (a history of myocardial infarction with or without ST elevation or unstable angina,     acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina     pectoris with documented coronary artery disease by prior coronary angiography or ECG) or     overt heart failure (NYHA class III-IV).   "
74543|NCT02310048|"     The purpose of this study is to assess the comparative oral bioavailability of a Formulation     B versus the Formulation A of MT-1303.   "
74544|NCT02310035|"     Blood sampled for standard evaluation will be used for determination of plasma glutamine by     Bioprofile Flex Glutamine Sensor at ICU admission   "
74545|NCT02310022|"     Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3     medication comparator.   "
74546|NCT02310009|"     Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c>7%) will be assigned to one of     the 4 following interventions in a randomised, parallel group design: [I] Control (placebo     injection; no exercise), [II] Anakinra (100 mg subcutaneous injection of human recombinant     interleukin-1 receptor antagonist), [III] Exercise (1 h cycle ergometry at 75% VO2max), [IV]     Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be     measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal     glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).   "
74723|NCT02307695|"     To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the     glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon     secretion, improving beta cell function, and re-regulating of the T cell immune system.   "
74547|NCT02309996|"     Supervisors of injured workers play a key role in preventing prolonged work absences.     Providing supervisors with tools to improve their response to musculoskeletal and other     workplace injuries or illnesses may improve worker health and disability outcomes.      The primary objective of this research study is to determine the effectiveness of the     supervisor training program, the SMART Supervisor Training Program, on reducing the total     duration of workers' lost-time claims. The secondary objectives are 1) to determine the     effectiveness of the training program on reducing the cumulative incidence of workers'     lost-time injuries and sick leave days; 2) to determine if implementation of the training     program is associated with improvements in hypothesized mediating variables, such as     attitudes toward job accommodations, response to workplace injury, and communication with     employees and healthcare providers; 3) to investigate the implementation of the training     program by conducting a process evaluation.      The investigators hypothesize that:        1. the duration of lost-time claims for workers working under supervisors receiving the          training program will be shorter than the duration of lost-time claims for workers with          supervisors in the control group;        2. the cumulative incidence of lost-time injuries and sick leave days will be lower in the          group receiving the training program compared to the control group;        3. the training program will be associated with increased knowledge, response,          communication and changed attitudes towards workplace accommodation.      This research is of significance to North American employers and compensation systems because     there is a lack of knowledge about the usefulness of supervisor training to prevent or reduce     work disability. It also has important implications for guiding employer policies and     practices, and for identifying circumstances where supervisor training should be a priority.   "
74548|NCT02309983|"     For many after spinal cord injury (SCI) there is immobilization, muscle atrophy, bone loss,     fracture risk during transferring (or falls), and the risk of secondary complications, and     increase in attendance care and cost. It is important to develop multi dimensional     rehabilitation strategies for people after SCI to enhance functional recovery towards     walking, and enhance an increase in muscle and bone to potentially prepare the injured     nervous system in the event of a cure. Locomotor training (Stand retraining and step re     training) an activity-based rehabilitative approach generates muscle activity and provides     weight bearing and joint contact kinetics, even in individuals who are unable to stand or     step independently. Cross-sectional animal and human SCI studies have demonstrated that     locomotor training (LT) (stand retraining and step retraining using body weight support     treadmill training) has improved the capacity to stand independently and walk at faster     speeds. Neuromuscular stimulation (NMS) or electrical stimulation (ES) training is a     rehabilitative approach that generates muscle activity, alternating leg extension and flexion     even in individuals who are unable to stand or step independently. NMS studies for     individuals after SCI have shown improvements in bone density and muscle strength after     cycling and resistance training. The main purpose of this study is to address whether stand     retraining and NMS compared to stand retraining alone or NMS alone will increase neural and     musculoskeletal gains and provide a greater functional recovery towards independent standing.      This project will be completed at two sites: Kessler Foundation Research Center (the grant PI     site) and Frazier Rehabilitation Institute, University of Louisville, Kentucky.   "
74549|NCT02309970|"     CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which     are only partially or insufficiently perfused during an acute ischemic event. The     differentiation between the core infarct and the still viable penumbra is its major clinical     application. CTP helps directly in the decision-making process in the event of acute ischemic     stroke by increasing the potential of success in patient who can benefit from     thrombolytic/endovascular treatment.      The use of CTP in patient selection for thrombolytic/endovascular treatment was never     evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a     good correlation between the size of the penumbra and the clinical outcome when done in early     as well as late stages of the event.      The importance of identifying the penumbra in the acute phase of the ischemic stroke is     widely accepted. But crucial evidence to support the predictive value of CTP to predict the     clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.      Currently, the use of CTP is based on theoretical assumptions and expert opinions but a     randomized prospective study to validate its use is lacking.      The current guidelines restrict the use of CTP trials and to patients that can't performed     MRI scan.   "
74550|NCT02309957|"     Prospective, multi-center, non-randomized, historical controlled, post-market study of     patients requiring surgical repair of a focal articular cartilage lesion or osteochondral     defect in the knee.   "
74551|NCT02309944|"     The purpose of the study is to test whether the use of a new wound closure technique can     decrease the rates of wound complications in obese cancer patients.   "
74552|NCT02309931|"     The study will provide a precise control compared to the two interventions (iso vs     antiperistaltic anastomoses) with thorough measurements of the postoperative variables and     complications to improve the evaluation of the surgical technique. It will also enable an     evaluation of the quality of life after the procedures.   "
74553|NCT02309918|"     This is an open-label, single arm, multicenter, pilot-study to compare the efficacy and     safety of LDV/SOF fixed dose combination (FDC) in subjects with acute genotype 1 HCV     infection. A total of 20 subjects will be assigned to receive LDV/SOF FDC tablet (LDV 90     mg/SOF 400 mg/) once daily for 6 weeks.Patients will be followed up for 24 weeks.   "
74554|NCT02309905|"     The purpose of this study is to determine whether Tele-expertise would be effective and     cost-effective by reducing the number of secure transportations for inmates in need of a     dermatological consultation   "
74555|NCT02309892|"     The primary purpose of this research study is to evaluate how safe, how well tolerated and     how effective a range of doses of L-DOS47 in combination with standard doublet therapy of     pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic     non-squamous Non-Small Cell Lung Cancer.   "
74556|NCT02309879|"     This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium     sulphate and remifentanil in patients undergoing mastectomy   "
74557|NCT02309866|"     Retinitis Pigmentosa (RP) is the most common form of hereditary retinal degeneration, with a     worldwide prevalence of 1:3500. It is one of the most genetically heterogenous conditions in     humans, with over 100 causative genes and loci reported to date. However, in approximately     40% of patients the underlying genetic causes are yet to be found.      The current study aims to identify causative RP genes and mutations in Israeli families of     various ethnic backgrounds. Identification of such genes will contribute significantly to     disease prevention (by identification of high risk families and appropriate genetic     counseling) and to the investigators understanding of retinal structure and function and of     the etiology of RP.   "
74558|NCT02309853|"     The purpose of this study is to evaluate whether 20 Sessions of 30 minutes with a visual and     tactile scanning training in the personal, peripersonal and extrapersonal space combined with     trunk rotation will be feasible and provide better results compared to 20 Sessions of 30     minutes of a standard visual scanning programme.   "
74561|NCT02309814|"     The investigators have developed a simple to use device that facilitates the monitoring of     the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and     graphic presentation of the results. the device system consists 3 components : glasses for     the patient including magneto sensitive probes, hardware and dedicated software.      Our purpose is to characterize eyelid motion in normal population. The methods include     measuring each patient 10 minutes during watching a short movie.   "
74562|NCT02309801|"     The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2     (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in     humans.   "
74563|NCT02309788|"     Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia,     but the five-year relative survival rate is relatively quite low1-3. As a common complication     of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~     50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon.     Nevertheless, the patients overall survival (OS) varies on their clinical features or liver     function4. For HCC PVTT treatment, current options are surgical resection, embolization     chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene     therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and     it is changing from the past palliative treatment to current curable treatment. From an     oncologic point of view, a narrow margin <1 cm is not safe and is often associated with     higher rates of recurrence and shorter patient survival.On the other hand, it is also     believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are     distant from the resection margin.To address this issue, the investigators are going to     conduct a series of retrospective and prospective studies to investigate the effect of     adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor     recurrence.   "
74564|NCT02309775|"     Objectives: Verify the effect of auriculotherapy in patients with tension-type headache     resulting from temporomandibular dysfunction.      Design: Randomized clinical study Setting: Randomized Study Participants: The study consist     of 38 participants randomized into two groups: an intervention group (n = 18, sample loss =     1) and placebo group (n = 20, sample loss = 6) Interventions: The intervention group will     receive treatment with auricular acupuncture in the Shen Men, Kidney, Sympathetic, Subcortex,     Adrenal and Cerebral points. The placebo group will receive auriculotherapy in the trachea     point.      Main outcome measures: visual analog scale for pain pain (VAS) and surface electromyography     (EMG).   "
74565|NCT02309762|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     immunogenicity of single-ascending IV doses of FB825   "
74566|NCT02309749|"     This is a pilot to review the feasibility of a program that assists patients towards therapy     compliance by scheduled intervention through the first month of therapy. The hypothesis of     this study is that the trial program will function as intended and average patient adherence     will be over 4 hours per night.   "
74567|NCT02309736|"     This is a prospective multicenter observational single arm post-approval registry that will     collect post-approval data relative to the incidence of endophthalmitis for cataract surgery     patients treated with the FDA-approved ReSure Sealant when used by a broad group of     physicians under commercial use conditions.   "
74568|NCT02309723|"     When older patients develop cognitive problems - like memory loss - there may be any of     several underlying causes, sometimes occurring in combination. Clinicians have a better     chance of providing appropriate treatment if they understand what the cause of the problem     is. A diagnostic tool can help the patient by helping the clinician to make a more accurate     diagnosis. This study investigates whether a new diagnostic tool - beta amyloid imaging - may     potentially improve medical practice. The tool can potentially improve practice only if it     can influence clinical judgment. This study investigates whether the provision of beta     amyloid imaging information influences clinical judgment. The investigators will conduct a     survey that presents clinicians with descriptions of hypothetical older patients with     cognitive complaints. Some of the respondents also receive beta amyloid imaging information.     The investigators will test the investigators hypothesis that the information will affect     diagnostic judgment and management recommendations by comparing the responses of clinicians     who receive the beta amyloid information to the responses of clinicians who do not.   "
74569|NCT02309710|"     This prospective study will evaluate the safety and acceptability of the ShangRing device for     medical male circumcision (MMC) during routine service delivery in Namitete, Malawi   "
74570|NCT02309697|"     This study will utilize two validated tools for assessing child development and behavior, to     investigate the outcomes for children born preterm compared with those born at full term. Two     hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be     enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which     will assess development in an examination administered by a trained occupational therapist at     Mount Sinai Hospital.   "
74571|NCT02309684|"     The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and     compare its performance with the standard of care at NFRMC Wound Therapy Services, for the     treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm     clinical study.   "
74572|NCT02309671|"     This trial investigates the effects of several doses of FE 999049 in Japanese women     undergoing IVF/ICSI treatment.   "
74573|NCT02309658|"     The propose of this study is to determine if neoadjuvant chemotherapy followed by     chemoradiation is safe and effective in locally advanced cervical cancer patients. Moreover,     the study would determine if there is any association between hENT1 expression and response     rate to gemcitabine.   "
74574|NCT02309645|"     The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for     suture-line sealing in dura-mater closure in elective or urgent paediatric cranial     neurosurgery to provide intraoperative watertight closure.   "
74575|NCT02309632|"     100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes     associated with increased risk of pancreatic cancer, will be followed for five years. This     data will be used to determine the pancreatic cancer and precancerous lesion detection rate     in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers     or to biomarkers only.   "
74576|NCT02309619|"     Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer     deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective     management for resectable EC. Gastric tube is considered to be an ideal substitute for the     resected esophagus and can be lifted to the neck for anastomosis through two different paths     — Trans-substernal and trans-esophageal bed routes. However, the differences of operative     outcomes between the two paths have not been systematically described. In this study,     clinical outcomes including intra- and post-operative status, morbidity and complications,     nutrition status, as well as quality of life after surgery will be evaluated, and differences     between the trans-substernal and trans-esophageal bed groups will be compared. The study     might help to individualization treatment for EC.   "
74577|NCT02309606|"     Migraine affects 16% of the world population and is one of the most disabling of all     disorders. It is a complex brain disorder characterized primarily by recurrent headache     attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been     thought to play a central role in migraine pathophysiology. The most effective class of     abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific     actions of serotonin and the mechanisms of triptans are still unknown. In this project the     investigators will use high-resolution positron emission tomography and specific radioligands     to investigate the significance of serotonin in migraine. Two newly developed radioligands     that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be applied. To     investigate the level and distribution of serotonin in the migraine brain the investigators     will compare the binding of these ligands in episodic migraine patients with healthy     controls. In addition, the investigators will include chronic migraine patients to evaluate     the relation between the level of serotonin in the brain and the frequency of migraine     attacks. To investigate the changes in the serotonin level during a migraine attack and the     effects of triptans on the central nervous system the investigators will repeat the scans     using the 5-HT1B specific ligand during induced migraine attacks and following treatment with     sumatriptan. The results from this study will shed light on the role of serotonin in the     migraine brain and elucidate the migraine-specific action of triptans. This will improve our     understanding of the migraine pathophysiology and, potentially, facilitate the development of     more efficient treatment of migraine.   "
74578|NCT02309593|"     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to     evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing     components marketed in the European Union (EU). These types of studies are required by     regulatory authorities for all THA and resurfacing devices that do not have medium to     long-term clinical evidence available at the time of gaining approval to market in the EU.     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2     rev 2.   "
74579|NCT02309580|"     This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1     clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with     T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this     phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see     what effect the drug has on the patient and the disease.   "
74580|NCT02309567|"     p53 is a tumor suppressor gene which plays an important role in controlling normal cell     proliferation regulation that is located on the chromosome 17 (17p13.1). It is the most     common goal of genetic alteration in many tumors. Serum p53 protein is presence in normal     healthy individuals. However p53 antibody is extremely rare. Mutations in this gene cause an     accumulation of non-functional proteins and development of anti-p53 antibodies, which can be     detectable in tissues, slouhed cells, blood and other body fluids. Some studies have reported     that, p53 mutations are highly common in leukemia, lymphoma, lung, esophagus, stomach, liver,     bone, bladder, ovarian, and brain cancers. Lung cancer is the most common cause of     cancer-related deaths and the survey is low after the initial diagnosis. Accurate staging is     important for determine the choice of treatment and predict prognosis. 18F-FDG PET/BT has     important value for initial staging and it is the most advanced imaging technique developed     all over the world for determine of the characterization of the metabolic tumor volume.     Maksimum Standardized Uptake Value (SUVmax) which was acquired by PET imaging is commonly     used in clinical practice as a criterion for malignancy. Due to the development of new     software programs recently studies have shown that metabolic tumor volume (MTV) and total     lesion glycolysis (TLG) may be useful quantitative parameters for the prognostic evaluation.     Viable tumor volume could be estimate with this programs.The purpose of this study was to     assess the relation between serum anti-p53 antibody level and quantitative PET parameters as     SUVmax, SUVave, MTV and TLG.   "
74581|NCT02309554|"     This post coital test study is a Phase I multi-center, randomized, crossover, non-significant     risk device study to be carried out at two clinical sites/centers. The products to be tested     are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with     ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of     product use, with a goal of 10 participants completing the study.   "
74582|NCT02309541|"     The purpose of this study is to evaluate audio quality benefit for the patient implanted with     a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm)     whatever the patient environment is and to evaluate the functional gain and speech     understanding benefit for the patient upon the firmware used (new and reference firmware).     The new firmware aims to adapt automatically for feedback cancellation without prior     calibration.   "
74583|NCT02309528|"     Few educational intervention clinical trials have been conducted among those at risk for or     with early chronic kidney disease. To the investigators' knowledge none have used digital     storytelling as a means to deliver the educational message and have been conducted among     American Indians, a group with high prevalence of chronic kidney disease and end stage kidney     disease.      The aims of the research project are to:        1. Quantify levels of chronic kidney disease knowledge and awareness among American          Indians.        2. Determine the effectiveness of a culturally tailored health presentation with          computerized digital stories made by American Indians for improving chronic kidney          disease knowledge and factors thought to be preventative of chronic kidney disease or          its progression at baseline and follow-up in a pilot educational clinical intervention          trial.   "
74584|NCT02309515|"     This randomized phase II trial studies how well lenalidomide improves immune response to     pneumococcal 13-valent conjugate vaccine in patients with chronic lymphocytic leukemia, small     lymphocytic lymphoma, or monoclonal B cell lymphocytosis. Biological therapies, such as     lenalidomide, use substances made from living organisms that may stimulate or suppress the     immune system in different ways and stop cancer cells from growing. Lenalidomide may also     improve the effectiveness of pneumococcal 13-valent conjugate vaccine that is used to prevent     infection.   "
74585|NCT02309502|"     Diabetic retinopathy (DR) is a leading cause of new cases of blindness in people aged 20 to     65 years worldwide.      Patients with DR may go on to develop a more severe form of the disease called Proliferative     Diabetic Retinopathy (PDR), a condition in which abnormal new blood vessels may rupture and     bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal     photocoagulation (laser treatment) is usually recommended.      The purpose of the investigators study is to find if treating patients using a single session     of lower intensity laser (Pascal® Pan Retinal Photo-Stimulation, P-RPhS) at an earlier stage     in Diabetic Retinopathy (during the severe non-proliferative diabetic retinopathy stage) when     the abnormal new vessels are not developed, will prevent diabetic patients to develop PDR.      Patients included in the study will be randomized in three arms (randomization). In one arm     patients will be treated with the normal parameters used in Pascal® laser, the second arm     patients will be treated with a lower intensity than normal, using the Endpoint management     system (a new software from the Pascal® laser which allow us to decrees the intensity of the     burns (invisible burns) showing some landmarks with normal intensity so the area which has     been treated can be viewed. And in the third arm the patients will be observed.   "
74586|NCT02309489|"     The uptake of postpartum contraception, postpartum care attendance and the practice of     exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in     maternity care has been shown to be a promising strategy for the achievement of other     reproductive health goals, little is known about the effect of their participation on these     outcomes. This study aims to test whether the involvement of men can improve care-seeking and     promote healthy behaviours among postpartum women in Burkina Faso.   "
74587|NCT02309476|"     Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to     decrease the intensity of the burns (invisible burns) showing some landmarks with normal     intensity so the investigators can see the area which has been treated. The Pascal® system     with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was     utilized in previous Pascal® laser studies.      This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and     effectiveness as 532nm Pascal® in the treatment of diabetic macular oedema.   "
74588|NCT02309463|"     The objective of the study is to monitor physical activity longitudinally with a wrist     activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the     correlation with the 6MWD at different time points. Further objectives are to assess the     correlation of physical activity measured with the tracker and other parameters for clinical     evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class,     hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy     in PAH patients newly initiating ERA therapy.   "
74589|NCT02309450|"     ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with     Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of     pegylated Interferon-Ribavirin regimen.      Proportion of patients with cirrhosis will be limited to 50% of all patients included,     cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse     elastometry ≥ 14 kPa or a Fibrotest® result > 0,75.   "
74590|NCT02309437|"     The present study is a superiority research, to evaluate the nutrition status, quality of     life, influence on clinical outcome, and the adverse effects of the early use of OxyContin on     the pain induced by radiation oral mucositis in nasopharyngeal carcinoma patients.   "
74591|NCT02309424|"     This open, randomized, cross-over, placebo-controlled study aims to investigate the effects     of vinegar on glucose metabolism, endothelial function and circulating lipid levels in     subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous     difference technique.   "
74592|NCT02309411|"     The purpose of this study is to find out whether rivaroxaban is safe to use in children and     how long it stays in the body. Safety will be assessed by looking at the incidence and types     of bleeding events. There will also be a check for worsening of blood clots.   "
74593|NCT02309398|"     The purpose of this study is to develop and implement quality improvement programs for the     treatment of atrial fibrillation (AF) in China based on the successful experience of the     AHA‐Get with the Guidelines program. This two-year program will use data collection,     analysis, feedback, and process improvement to extend the use of evidence-based guidelines     throughout the healthcare system and improve patient care of atrial fibrillation.   "
74594|NCT02309385|"     The purpose of this study is to determine the efficacy, safety, and tolerability of     dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in     patients with acute anterior uveitis.   "
74595|NCT02309372|"     This trial will determine if depression treatment will reduce cardiovascular risk in     HIV-infected patients already receiving HIV treatments. Half of the participants will undergo     a specific computerized depression treatment with the other half receiving usual care from     their HIV providers.   "
74596|NCT02309359|"     The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061     administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with     active RA despite MTX therapy, compared with placebo.      To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics     (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061,     based on safety and efficacy, for further clinical development.   "
74597|NCT02309346|"     Septic abortion is a serious condition. Women with septic abortion are treated with     clindamycin plus gentamicin using divided doses, i.e., thrice a day.      The objective of this study is to compare the rates of cure between once or thrice a day use     of clindamycin with gentamicin in cases of septic abortion.   "
80944|NCT02226432|"     The objective of the present trial is to demonstrate Magnetic stimulation as an useful     complementary treatment in order to improve patients' evolution without the need of extensive     surgical lesion.   "
74598|NCT02309333|"     Acute promyelocytic leukemia (APL) is a very rare type of leukemia. Because it is so rare,     many doctors do not have experience treating it. APL has been shown to be curable most of the     time. Unfortunately, some patients die early after they become sick with APL, sometimes even     before starting treatment. The early period is from the time of diagnosis through the first     treatments for the disease. This is approximately 30 days. Early deaths are often due to     complications caused by of the effects of leukemia and the treatments of it. These     complications may not be noticed quickly by doctors who don't have much experience with     managing APL.      The purpose of this study is to collect information about the diagnosis and management of APL     patients by review of their medical records. This information will be stored in a central     database at Emory University. This data will be analyzed to discover the impact of increased     physician knowledge of recommended management of APL. The goal is to reduce the events of     early death of APL patients.   "
74599|NCT02309320|"     The primary objective of the study is to investigate the safety and tolerability of ALX-0171.      The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the     pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.   "
74600|NCT02309307|"     The VergenixTM STR device is intended for the repair of non ruptured tendon injuries     (Tendinopathy).   "
74601|NCT02309294|"     The objective of this study is to determine the ability of the study material to cause     irritation to the skin of humans under controlled patch test conditions. Substances that come     into contact with human skin need to be evaluated for their propensity to irritate and/or     sensitize. This testing is a modified primary irritancy patch test that can detect weak     irritants that require multiple applications to cause a skin reaction.   "
74602|NCT02309281|"     Title: Intravitreal aflibercept (VEGF Trap-Eye) in neovascular age-related macular     degeneration with limited response to ranibizumab      Purpose: The purpose of this investigator initiated study is to identify the duration of     treatment effects of intravitreal aflibercept on sub- and intraretinal fluid and best     corrected visual acuity (BCVA) in choroidal neovascularizations (CNV) due to age-related     macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment     interval failed to be extended to 6 weeks intervals in a treat and extend regimen.      Objectives: The primary objective is to evaluate the mean maximum recurrence-free treatment     interval (Imax in weeks) with aflibercept treatment during the 24 months study peroid (for     explanation see section Objectives). The individual maximum recurrence-free treatment     interval (in weeks) at 24 weeks is defined as the maximum extension interval which is reached     during the study follow-up period without showing any CNV activity (any intra-or subretinal     fluid at OCT or new retinal hemorrhage). This measure reflects the duration of aflibercept     effect in these lesions with limited response to ranibizumab. Key secondary Outcome Measures     are mean changes in BCVA score at 24 weeks from baseline (Δ BCVAscore), mean changes in CRT     (µm) at 24 weeks from baseline (Δ CRT), mean number of treatments needed during the 24 weeks     study follow-up, number of participants with adverse events and serious adverse events (for     further outcome measures see section Objectives).      Population: This outpatient study population will consist of a representative group of 33     male and female patients ≥ 50 years of age. The study population will include patients with     subfoveal CNV secondary to AMD and being pre-treated with intravitreal ranibizumab in a treat     and extend regimen and failed to be extended to 6-weeks intervals without showing CNV     activity (for further information see section Criteria).      Interventions: 1-arm interventional study with 2mg aflibercept intravitreally up to 4-weekly.     The first treatment interval with aflibercept will be 4 weeks and corresponding to the treat     and extend regime intervals will be increased in 2-weeks-steps as long as no CNV activity     (any intra-or subretinal fluid at OCT or new retinal hemorrhage) occurs. In case of occuring     CNV activity the interval is shortened by 4 weeks with a minimum treatment interval of 4     weeks.   "
74603|NCT02309268|"     The purpose of this research is to monitor how well patients do after surgery for treatment     of left atrial appendage (LAA).   "
74604|NCT02309255|"     The NOR-COR study is a cross-sectional, observational study designed to explore a large     number of cardiovascular, inflammatory, genetic, behavioral, and psychosocial factors     (including anxiety, depression, quality of life) in 1369 patients with established coronary     heart disease (CHD) hospitalized in the Sections for Cardiology at the hospitals in Drammen     (n=722) and Vestfold (n=647). Study data from an extensive questionnaire, clinical and     laboratory data, and sputum/saliva for genetic analyses will be collected.      The main overall aim of the NOR-COR study is to develop new strategies to improve secondary     prevention for underserved high risk patient-groups with CHD. The first study phase aims to     collect information necessary to develop empirically based future secondary coronary     prevention interventions. In a genetic sub-project markers associated with CHD and     personality type will be explored.      The study will evaluate current secondary preventive programs and explore the mechanisms that     link behavioral, psychosocial, inflammatory, and genetic factors to poor prognosis. The study     will in short term provide new knowledge potentially useful for increasing participation in     current cardiac rehabilitation/secondary preventive programs. For a longer perspective these     associations may be useful for design of new intervention programs to selected high risk     patient groups whom may be in need of programs with different content and/or of longer     duration than those currently being applied.   "
74605|NCT02309242|"     The aim of the proposed project is to study the long-term impact of adjuvant systemic multi-     agent chemotherapy (cisplatin, anthracyclines, vincristine, methotrexate, alkylating agents)     in survivors (treated between 1992 and 2014 in UZ Leuven) of paediatric bone or soft tissue     sarcomas on neurocognitive functioning.   "
74606|NCT02309229|"     To use the sputum colour chart as a predictor for cystic fibrosis exaerbations   "
74607|NCT02309216|"     The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI     for suspected child abuse      Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the     routine care of the hospitalized infant with comparison to routine radiographic skeletal     survey images      Procedures to be used: whole-body MRI images      Risks and potential benefits: no additional risk (the infant will be receiving and MRI of     their brain as part of routine care, the additional images will be obtained at the same time     without additional sedation); benefits to the infant include the identification of injuries     which would have otherwise been missed by routine care importance of knowledge that may     reasonably be expected to result: results from this study will potentially influence the use     of radiographic skeletal survey and decrease the radiation exposure to infants being     evaluated for suspected child abuse.   "
74608|NCT02309203|"     The study objective is to evaluate the safety and effectiveness of the MicroVention FRED     System when used in the treatment of wide-necked intracranial aneurysms.   "
74609|NCT02309190|"     The study consists in determine the transpulmonary pressure in morbidly obesity patients that     require mechanical ventilation.        -  both gender        -  only adults        -  Medical intensive care patients.   "
74610|NCT02309177|"     The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens     administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small     Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).   "
74612|NCT02309151|"     The overall aim of this prospective, randomized pilot study is to investigate whether acute     coronary angiography (within 120 minutes) with a predefined strategy for revascularization,     is safe to implement in patients with out of hospital cardiac arrest. The primary question at     issue is whether early angiography (within 120 minutes) with a predefined strategy for     revascularization with percutaneous coronary intervention (PCI) is safe to carry out in this     group of patients. The patients randomized to acute coronary angiography will be compared     with a control group who will be treated according to standard practice with coronary     angiography with possible subsequent intervention according to the current routine, which     usually does not occur within the first three days after cardiac arrest.   "
74613|NCT02309138|"     This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to     compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes.     Maternal metabolic profiles and infant growth will be assessed at randomization and at one     year postpartum.   "
74614|NCT02309125|"     The aim of this split mouth study is to compare which method is better in reducing bone loss     and healing times following implants. Specifically, the two methods investigated will be     immediate gradual loading and early loading protocol.      Research Hypothesis Immediate gradual loading using gingival formers is superior to early     loading protocols in improving bone quality and thus reducing the healing time.   "
74615|NCT02309112|"     A feasibility study to determine the appropriateness of yoga intervention to improve     health-related quality of life in adult cancer patients.   "
74616|NCT02309099|"     The goal of this project is to determine whether subjects who have undergone labyrinthectomy     or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or     Meniere's disease benefit from cochlear implantation on speech perception and localization     tasks.      If the auditory nerve is able to transmit this signal effectively, then these two populations     may be able to utilize the combination of electric (in the affected ear) and acoustic (in the     non-affected ear) information for improved speech perception in noise and localization as     reportedly experienced in other unilateral sensorineural hearing loss populations.   "
74617|NCT02309086|"     Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown     to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is     to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV     patients using autologous DC transduced with a recombinant adenovirus encoding NS3   "
74618|NCT02309073|"     Background: Despite considerable progress in the field of assisted reproductive technology     (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial     differences in pregnancy rates are seen between women starting ART from seemingly similar     clinical starting points and information on pregnancy/neonatal complications after ART is     limited. For physicians and patients it would be extremely valuable if tools could be     developed through which individualised chances of live birth and the development of     pregnancy/neonatal complications can be calculated. In addition, there is increasing     knowledge about health risks associated with subfertility and in particular with polycystic     ovarian syndrome (PCOS) and premature ovarian failure (POF). An important void in research to     date is the absence of a control group to check important new findings.      Objectives: The study protocol aims to form a cohort of normo-ovulatory women with a regular     indication for ART which can aid the investigators principle lines of research:        1. To study initial predictors of ovarian response to stimulation for IVF        2. To study predictors of chances for live birth after repeated IVF cycles        3. To assess the role for vascular health in the probabilities of success in ART treatment        4. To study predictors for pregnancy and neonatal complications        5. To form a control group for cycle disturbance studies      Study design: In this part of the protocol, serum and material for DNA analysis will be     collected by asking patients to have 20 ml of blood drawn during a routine blood withdrawal.     This blood will be stored in the Biobank of the UMC Utrecht at -80 C.      Study population: All women starting ART will be asked to participate.      Nature and extent of the burden and benefits associated with participation: There are no     benefits or risks for the study patient as blood is withdrawn during a routine venapuncture     and results will not be used for clinical practice.   "
74619|NCT02309060|"     The overall aim of this program of research is to develop a collaborative narrative     intervention for patients with depression being treated in primary care.      The purpose of the proposed project is to establish the feasibility, acceptability, and     preliminary effects of our newly developed narrative intervention on depression.      To achieve the specific aims, the investigators will conduct an open trial to further develop     and refine the intervention (n = 10).   "
74620|NCT02309047|"     Through the COLA Study and Biobank the investigators hope to enable further identification of     phenotype, endocrine, ethnic, and metabolic characteristics associated with menstrual cycle     disturbances; and: the identification of genetic or other etiologic factors associated with     cycle disturbances.   "
74621|NCT02309034|"     Objective: To compare the results of two types of low-impact exercise training, in and out of     the water, with the control group, regarding cardiometabolic risk factors in overweight     adolescents; and to investigate the changes resulting from interventions in biochemical,     anthropometric, psychological variables and body composition.      Experimental design: Randomized clinical trial with overweight and obesity adolescents.      Local Search: College of Physical Education of Federal University of Rio Grande do Sul and     Hospital de Clinicas de Porto Alegre, city of Porto Alegre, Rio Grande do Sul State, Brazil.      Participants: Took part in the study 75 overweight and obesity adolescents, pubertal and     post-pubertal, recruted by announcement in the most important newspapers of Porto Alegre     city.      Intervention: Adolescents that acepted to participate in the study, and authorized by their     parents, were randomized into three groups: Group Land / Jump, with three weekly sessions     Jump; Water / hidrogimnastic group, with three weekly sessions of hidrogminastic; Control     group that not participate in physical exercise intervention. The intervention will last 12     weeks and three groups participate in weekly sessions of nutritional guidance. Assessments     occur at the beginning of the intervention program and 72 hours after the 12th week of the     program. The results of all study variables among the three groups in the two time points,     and in each group between the two periods, will compared.      Measures: Anthropometric, biochemical and blood pressure evaluations, in addition to applying     instruments for assessing quality of life, body image and mental health by experienced     evaluators, as well as blood draws conducted by an experienced gatherer's Hospital de     Clínicas de Porto Alegre.      Expected Results: In the study, are been expected to verify that the exercise programs,     aquatic and land, associated with nutritional guidance, are efficient to modify positively     the outcomes studied.   "
74622|NCT02309021|"     The aim is to examine the effect of exercise (EX) training on individuals currently receiving     ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their     opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of     substances (e.g. street heroin, cocaine, cannabis, alcohol, cigarettes) other than     prescribed ST or other prescribed medications; substance craving; blood pressure; lung     function; resting pulse; social interaction; self-control capacity; objective and subjective     sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are     current substitution dose and psychiatric diagnoses.   "
74623|NCT02309008|"     The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of     PAC-14028 cream after transdermal administration in healthy male volunteers.   "
74625|NCT02308982|"     This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess     the role of intravenous immunoglobulin in the treatment of children with encephalitis. The     primary objective is to find out whether early use of IVIG treatment improves neurological     outcomes of children with encephalitis.      308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals in     the United Kingdom. Participants will be randomised to receive two doses of IVIG or matching     placebo in addition to other standard treatments, within the first five days of hospital     admission.      Each participant will be followed up for 12 months. During this period, information on     clinical, radiological and laboratory investigations will be collected. Neurological outcomes     will be assessed by the use of questionnaires at 6 and 12 months, and a neuropsychological     assessment at 12 months.   "
74626|NCT02308969|"     The aim of the present study is to assess the neuronal correlates of alterations in waking     consciousness pharmacologically induced by a 5-hydroxytryptamine (HT)2A receptor agonist in     healthy subjects using functional magnetic resonance imaging (fMRI).   "
74627|NCT02308956|"     Task sharing mental health care through integration of mental health into primary health care     (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in     low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe     mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely     due to scarcity of specialist mental health services. A task-sharing model of mental health     care in PHC would be more affordable and accessible to the majority of persons with SMD who     do not currently receive evidence-based mental health care. Furthermore, task sharing mental     health care with PHC is about to be scaled up in Ethiopia in line with the National Mental     Health Strategy. However, the effectiveness of the task sharing model of mental health care     for people with SMD has not been evaluated systematically in a low-income country. In this     study we propose to investigate non-inferiority of a task sharing model of mental health care     in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of     care. The specialist model of care has been demonstrated to be acceptable and associated with     improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus     making this an appropriate comparison model against which to evaluate non-inferiority of the     task sharing model.   "
74628|NCT02308930|"     The purpose of this study is to determine whether DHA supplement (in a daily dose of 300 mg)     will improve the cognitive performance, associated metabolism and growth in normal children     aged 6-12 years in primary schools.   "
74629|NCT02308917|"     The initial network clinical study will be an inception cohort study in children with new     onset IBD (Inflammatory Bowel Disease) rigorously phenotyped and prospectively followed.     Focusing on a prospective, inception cohort of Canadian children of widely varied racial     origins provides a unique opportunity to explore environmental risk factors early in life and     close in time to disease onset, their influence on the host microbiome, and in the context of     genetic susceptibility. In keeping with current treatment targets, assessed outcomes will     include not only symptom resolution and growth, but also intestinal healing. Anticipated     variation between network sites in choices of evidence-based therapies, even among     phenotypically similar sub-types of Crohn disease and ulcerative colitis, will allow     comparisons outcomes with disparate treatments, aiming to identify best practice and to     institute processes for continual improvement in care nationally.   "
74630|NCT02308904|"     The improved long-term survival of thalassemia major (TM) patients has resulted in increased     focus on the ability to preserve fertility. While the association of iron toxicity with vital     organ dysfunction, heart and liver, has been extensively investigated, the correlation of     reproductive capacity and extent of iron overload is not well understood. Despite remarkable     progress in methodology for prediction of reproductive status and intervention for preserving     fertility, implementation in thalassemia is lacking.      The investigators hypothesize that iron toxicity to the anterior pituitary occurring in the     process of transfusional iron loading is directly associated with a decline in gonadal     function. The investigators expect pituitary MRI measurements of iron deposition as well as     markers of oxidative damage to correlate with the functional studies of pituitary-gonadal     axis performed in this study. This cross sectional study will examine the relation of     pituitary iron deposition and pituitary volume; serum iron and oxidative stress measures,     liver iron concentration (LIC), cardiac iron and chelation adequacy with pituitary and     gonadal reproductive hormone levels (and spermatogenesis in adult male patients), in order to     better define the association of iron burden and chelation patterns with fertility potential,     in thalassemia patients with iron overload. The study will assess whether the current     chelation treatment regimens, in particular during the pubertal developmental age, are     adequate for preserving fertility and could lead to improved chelation routines for     preventing the high prevalence of compromised fertility. In addition, by utilizing     state-of-the-art markers for fertility status, findings from this study may improve current     methods for screening for hypogonadism and reproductive potential and allow earlier     intervention.      The investigators propose to examine 26-30 patients, 12 years and older, with measures of     fertility potential, and correlate them to their current iron burden parameters and to the     cumulative iron effect as indicated by past iron overload patterns and chelation history.   "
74631|NCT02308891|"     Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and     serious complication of ERCP procedures, occurring in approximately 5-15% of unselected     patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several     investigations in recent years. Hydration is considered a mainstay of treatment for acute     pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether     intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP     pancreatitis.      Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo     diagnostic or therapeutic ERCP will be recruited.      Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration     (treatment arm) or standard hydration (standard arm). Randomization will be performed in a     double blinded fashion using computer-generated random numbers.      Treatment arm (vigorous hydration arm);        -  Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP        -  Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and          continued for 8 hours.        -  At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over          1hour Standard arm (standard hydration arm);        -  Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids          will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after          ERCP.      The primary endpoint was development of post-ERCP pancreatitis, which define as increased     pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three     times the upper limit of normal).      The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of     pancreatitis, and fluid overload.   "
74632|NCT02308878|"     Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These     effects are evident in neuropsychological impairments in attention, memory and executive     functioning of heroin users. To assess these deficits and the application of a novel approach     of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried     out a neuropsychological intervention program with mobile health technology. Patients     diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in     a three-day/week basis.   "
74633|NCT02308865|"     Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing     early Palliative care versus Standard care in patients with non-small-cell metastatic lung     cancer   "
74634|NCT02308852|"     Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic     stroke patients to improve bimanual activities and motor learning.      Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying     bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.      A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for     motor learning.   "
74635|NCT02308839|"     This is a French Registry mandated by the French National Health Authority assessing     long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of     infra-renal Abdominal Aortic Aneurysms (AAA).   "
74636|NCT02308826|"     This project is intended to provide a rigorous test of the Turtle Program, an early     intervention program for behaviorally inhibited preschoolers. The proposed project will     extend promising pilot study findings by: (a) evaluating the integrated intervention in a     larger sample (n = 150) of 45-64 month children and their parents, which will allow for an     examination of mediators and moderators of treatment effects; (b) comparing the Turtle     Program to the best available treatment for preschool behavioral inhibition, the Cool Little     Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation     as both baseline moderators of treatment response and as outcome measures; (d) examining     parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment     assessment and extending follow-up to one year.   "
74637|NCT02308813|"     Several studies exist on patient performance in drive simulators especially around and after     surgery. Recommendations concerning the ability to drive preoperatively are based on these     studies, which generated their data using drive simulators. However, in all the datasets     driving performance remains highly individual. Since a drive simulator is not readily     available in normal general practitioner surgeries it would be helpful to have convenient     clinical tests to evaluate a patients individual ability to perform an emergency stop. This     study aims at evaluating different possibilities how such performance might be predicted.     Patients with hip osteoarthritis and patients who have received total hip arthroplasty are     tested clinically and their results are compared with the gold standard experiment - a drive     simulator.   "
74638|NCT02308800|"     The investigators plan a randomized clinical trial of 150 patients with infected     diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of     negative pressure wound therapy with continuous irrigation and negative pressure wound     therapy without irrigation.      The investigators will enroll 150 patients from two centers: The University of Texas     Southwestern University Hospital and Parkland Hospital. The investigators will screen and     enroll patients with wounds in the inpatient setting. Patients will randomized to receive     traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average     hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their     wound surgically closed during hospitalization will be discharged with negative pressure     wound therapy without irrigation for up to a total of four weeks of therapy. After discharge     from the hospital, subjects will be seen twice weekly by home health, and the investigators     will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or     until the wound heals.   "
74639|NCT02308787|"     Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia®     Apheresis System for Platelet Depletion Procedures.   "
74640|NCT02308774|"     We plan a cohort study of 40 diabetic patients admitted to Parkland hospital with a foot     infection. We will enroll a representative cross section of subjects with diabetic foot     infection. Patient will be consented and will receive therapy based on standard protocols.     Currently patients with suspected osteomyelitis have bone biopsies to identify bacterial     pathogens and verify MRI diagnosis. Repeat bone biopsies are performed at the end of therapy     to verify that osteomyelitis has been successfully treated. Serum to measure procalcitonin     will be obtained at baseline, week 3 and week 6.   "
74641|NCT02308761|"     RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET)     bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and     pharmacokinetics of RO6870810 monotherapy in participants with relapsed/refractory acute     myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome     (MDS). The study will consist of a Screening Period, Treatment Period, and Post-Treatment     Period. A standard 3+3 design will be used in which successive cohorts of three or more     participants with RR-AML or HMA-refractory MDS will be treated at escalating doses until a     maximum tolerated dose (MTD) is identiﬁed. Up to 51 adult participants with AML or MDS will     be enrolled in the study.   "
74642|NCT02308748|"     The primary objective of this research study is to test the hypothesis that late sodium     current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium     channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early     repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel     block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).   "
74643|NCT02308735|"     Gestational diabetes mellitus (GDM) affects as many as 14% of women in the United States.     Furthermore, the number of pregnant women with pregestational diabetes mellitus (PGDM) is     also increasing, mainly due to an increase in the diagnosis of non-insulin dependent diabetes     mellitus. A recent study demonstrated that 1.3% of pregnancies are now complicated by PGDM     and that PGDM now comprises 21% of the diabetes that complicate gestations, which represents     a two fold increase since 1999. One notable side effect of diabetes is an elevation of     endogenous ethanol production, which in turn may result in a rise in fetal production of     fatty acid ethyl ester (FAEE). FAEE found in meconium have been utilized as a marker of     prenatal ethanol exposure. Therefore, FAEE elevation could call into question maternal claims     of abstinence from alcohol during pregnancy. This study seeks to determine if meconium FAEE     levels in the newborns of abstinent women with various classifications of diabetes mellitus     are increased when compared to non-diabetic, abstaining controls.   "
74644|NCT02308722|"     In this study the investigators are testing if the addition of Stereotactic Body Radiation     therapy (SBRT) prior to surgery improves surgical outcome in patients with borderline     resectable or resectable pancreatic cancer (BRPC).   "
74645|NCT02308709|"     The primary objective of this study is to assess the safety and feasibility of personalized     radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation     imaging, which selectively avoids irradiating highly-functional lung regions.   "
74646|NCT02308696|"     The investigators' overall objective is to evaluate the effectiveness of peer-to-peer support     programs in preventing the necessity of acute health care and nursing home services for older     adult populations and in promoting their health and wellness. The investigators' Specific     Aims are:        1. To compare the effectiveness of peer-to-peer community support in preventing          hospitalization, emergency department (ED) use, and nursing home placement in an at-risk          older adult population relative to standard community services.        2. To compare the effect of peer-to-peer community support on intermediary measures of          health and wellness such as self-rated health, depression, and anxiety relative to          standard community services.   "
74647|NCT02308683|"     Current evidence supports a central role of inflammation in the pathogenesis of     atherosclerosis and diabetes [57-60]. Diabetes Mellitus type 2 is an inflammatory     atherothrombotic condition associated with high prevalence of thrombotic cardiovascular     disease. In patient with DM type 2, this inflammation is reflected by elevated plasma levels     of several biomarkers of inflammation such as C-reactive protein (CRP) [51-55]. HsCRP is     considered as a strong predictive of cardiovascular risks and death [53, 61-72]. Besides its     predictive role in determining cardiovascular risk, there is some evidence that CRP may     represent an active participant in atherogenesis [54]. CRP is expressed in human     atherosclerotic plaques and both vascular cells and monocytes/macrophages appear to represent     a significant source of CRP in the inflammatory vessel wall [54].      Among the DM risk factors (like hypertension, atherogenic dyslipidemia, insulin resistance,     impaired fibrinolysis, inflammatory profile), definitely, inflammation is the neglected one.      Moringa oleifera has been suggested to exert anti-inflammatory effects [42][43][45] and     hypoglycemic property [80]. As with many reports of the nutritional or medicinal value of a     natural product, there are an alarming number of purveyors of healthful food who are now     promoting M. oleifera as a panacea. While much of this recent enthusiasm indeed appears to be     justified, it is critical to separate scientific evidence from anecdote.      Herein, the investigators will investigate the effects of Moringa oleifera leaves     supplementation on levels of inflammatory marker specifically hsCRP, hgbA1c level and     clinical outocome in diabetic patients through a cohort study.   "
74648|NCT02308670|"     The primary aim of this study is to observe any changes in MRI in MS patients who have     switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.   "
74649|NCT02308657|"     The purpose of the study is to determine the best ways to assess how people are affected by     myotonic dystrophy type 1 (DM1). The study will assess walking speed, muscle strength, muscle     size, myotonia, heart rhythm, mental efficiency, and overall health. Participants will     complete questionnaires to record their ideas about how they are affected by DM1. The study     will evaluate people with DM1 over 1 year to determine how the condition changes over time.     The study will identify biomarkers of DM1. Biomarkers are laboratory measurements that show     the effects of DM1 on a person's muscle tissue or blood. Biomarkers are needed in future     studies to determine how DM1 may respond to treatments.   "
74650|NCT02308644|"     To evaluate the effects on contrast sensitivity (CS) measurements of intravitreal bevacizumab     injections associated with standard metabolic control in eyes with diabetic macular edema     (DME) associated with standard metabolic control.   "
74651|NCT02308631|"     Indications for colostomy are rectal or anal cancer, diverticular disease, radiation     enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and     functional disorders. It is frequently required in critically ill patients who may not be     able to tolerate a laparotomy. Laparoscopic-assisted colostomy is an alternative method for     colostomy without laparotomy, but require general anesthesia.      Additionally, percutaneous anterior colopexy under colonocopic control offers the possibility     for improved and faster fixation of the anterior colonic wall to the anterior abdominal wall.      The objective of this study is to evaluate the feasibility of performing fecal diversion with     the help of a colonoscope and colopexy, without the additional morbidity of abdominal     exploration.   "
74652|NCT02308618|"     The purpose of this study is to evaluate the effects of early mobilization versus traditional     immobilization rehabilitation programs after surgical Achilles tendon repair on the     mechanical (torque-angle and torque-velocity relationships) and electrical (neuromuscular     activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius medialis     morphology (muscle architecture), functional performance, and the mechanical and material     properties (force-elongation and stress-strain relationships) of the injured and uninjured     Achilles tendon.      The hypothesis is that the early mobilization could reduce the deleterious effects of the     joint immobilization and improve the tendon healing.   "
74653|NCT02308605|"     The hypothesis is that a stroke causes release of purines from brain into blood and that this     is a very early biomarker of brain ischaemia. The investigators propose a simple blood test     of substances (the purines) that result from cellular metabolism and are produced in excess     when brain cells are starved of oxygen and glucose (as occurs during a stroke).   "
74654|NCT02308592|"     The purpose of this pilot study is to examine the feasibility of conducting a multi-site     randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient     Decision Aid (PDA) for antidepressant use in pregnancy.   "
74655|NCT02308579|"     This a retrospective, blinded trial in which collaborators in Italy will review the doppler     findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an     attempt to measure reproducibility.   "
74656|NCT02308566|"     In this study, the investigators aim to compare cerebral embolic load in patients undergoing     surgical aortic valve replacement using either the minimized extracorporeal circulation or     the conventional extracorporeal circulation technique. The detection of cerebral emboli is     performed not-invasively by transcranial Doppler detection of high-intensity transient     signals representing solid or gaseous microembolism in the middle cerebral arteries. The     investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism     during aortic valve surgery using extracorporeal circulation.   "
74657|NCT02308553|"     This is a multicenter, randomized, double-blind, placebo-controlled phase I/II trial designed     to characterize the safety and estimate the efficacy of nintedanib when combined with     paclitaxel chemotherapy compared with paclitaxel chemotherapy alone in patients with BRAF     wild type metastatic melanoma not previously treated with taxanes or kinase inhibitors.   "
74658|NCT02308540|"     Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age     De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a     single-dose regimen to healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve young     adults and PCV-primed toddlers through 4 weeks post vaccination.      Each adult and toddler subject will undergo a total of 4 clinic visits. Each infant subject     will undergo a total of 9 scheduled visits. Blood will be collected from all subjects during     the screening visit for safety and potential immunological assessments, and 28 days after     completion of the vaccination schedule for immunological assessments. For adults, the vaccine     will be given IM into the mid-deltoid muscle of nondominant arm using a 24-gauge needle. For     toddlers and infants, the vaccine will be given IM into the anterolateral aspect of the left     thigh. Blood will be collected from adults and toddlers for safety labs at the Day 7     post-vaccination visit.   "
74659|NCT02308527|"     The purpose of this study is to investigate whether Bevacizumab (an anti-VEGF monoclonal     antibody) added to a backbone chemotherapy regimen (Temozolomide, Irinotecan-Temozolomide or     Topotecan-Temozolomide) demonstrates activity in children with relapsed or refractory     neuroblastoma. Also, to investigate whether the addition of Irinotecan or Topotecan to     Temozolomide increases the activity of chemotherapy.The primary objective of the study is the     best response (Complete Response or Partial Response) while trial treatment, within 18 or 24     weeks depending on the arm of the trial the participant is randomised to. Secondary endpoints     are assessing the side effects, the length of time before progression (Progression Free     Survival) and overall survival (OS).      This trial will address two important questions:        -  does targeting blood vessel development using bevacizumab, (a monoclonal antibody          against the Vascular Endothelial Growth Factor (VEGF)), add to the effect on a tumour          when used with existing chemotherapy, compared to the effect of the existing          chemotherapy alone (temozolomide)?        -  does the addition of a second chemotherapy drug (irinotecan or topotecan) increase the          effect on a tumour compared to the effect of one alone (temozolomide) Patients aged 1-21          years of age with relapsed or refractory high-risk neuroblastoma are randomised to one          of six treatment arms: Temozolomide (T), irinotecan-temozolomide (IT), bevacizumab-T          (BT), BIT (bevacizumab-IT), temozolomide-topotecan (TTo) or          bevacizumab-temozolomide-topotecan (BTTo).   "
74660|NCT02308514|"     In this study the investigators want to measure the impact or effects of adding     cryostimulation to the conservative care of chronic lateral epicondylitis. The rapid fall in     skin temperature above the injured tissues is presume to have a positive effect in the     healing process. The combination of conservative care and cryostimulation could then be     appreciated. The investigators chose to measure these effects with 3 elements: visual analog     pain scale, validated elbow questionnaire and pain free grip strength. This pilot study     consist in a two arm design, each arm including 15 patients.   "
74661|NCT02308501|"     A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by     In-Vivo Confocal Microscopy   "
74662|NCT02308488|"     Following consent, patients will receive 15 fractions of radiotherapy to the affected breast     and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging     obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique:     one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for     follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be     assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after     completion of radiotherapy. All patients will be followed for toxicity and outcome (local and     systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL     at baseline, week 3, day 45-60 and 2-yr follow-ups.   "
74663|NCT02308475|"     To assess the ability of a novel 3rd generation dual-source CT system to demonstrate     myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute     chest pain.   "
74664|NCT02308462|"     In order to identify psychological stress in children and adolescents of mentally ill parents     as early as possible, a special intervention program (CHIMPs = Children of mentally ill     parents) was developed. The study at hand will implement this intervention program at five     sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is     assumed to reduce children's psychopathology and enhance their health related quality of     life.   "
74665|NCT02308449|"     Iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse     outcome. This human physiology study will examine the extent to which human skeletal muscle     metabolism and exercise physiology are impaired by iron deficiency.   "
74666|NCT02308436|"     In vitro results showed a protective effect against acids for the mouthwash containing     Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under     natural oral conditions on the tooth surface and to proof the in vitro results obtained. So     far there are no effect and safety data of the Curolox™ mouthwash under natural oral     conditions available.   "
74667|NCT02308423|"     in this study the investigators will call patients who had Subchondral fractures and treated     in our department over the last 20 years.      The investigators will evaluate their shoulder function by a questionary, Constant score and     radiologic evaluation.   "
74668|NCT02308410|"     A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on     postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear.     The purpose of the present study was to compare tourniquet use versus non-tourniquet use     during total knee arthroplasty for short-term functional recovery.   "
74669|NCT02308397|"     The aim of the study is to produce a tolerable alternative to normal wheat bread which would     be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread     would be made from wheat so, in contrast to gluten-free bread, would be more comparable to     standard bread. To make this bread, the investigators will use advanced enzyme technology     and/or novel formulations to target the digestion or removal of wheat proteins, which might     be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other     those that are more useful for baking quality. The investigators will determine palatability     and tolerance of this new product in a human cross-over, randomised, blind and     placebo-controlled intervention study.      It has been estimated 6-10% of the population are sensitive to gluten who do not have coeliac     disease (CD). Three breads will be produced and tested in this study against a suitable     reference based on standard wheat flour and baking process   "
74670|NCT02308384|"     Background      Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of     patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many     patients present with uncharacteristic or vague symptoms. The faecal marker of human globin,     iFOBT, could play an important role in aiding the general practitioner in detecting CRC.      Hypothesis      It will be possible to implement iFOBT in general practice as a test performed on patients     who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose     symptoms could indicate an undiagnosed colorectal cancer.      Aim      To implement iFOBT in general practice and evaluate the uptake and clinical use of the test.     Furthermore, we want to investigate the performance of iFOBT when used on patients presenting     with uncharacteristic symptoms of CRC, and the clinical implications.      Materials and methods      The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18     municipalities in the central Denmark Region, and these are randomised when to receive a     continuous medical education (CME). The date of inclusion is defined as the first working day     in the month the CME is planned to be conducted. The CME is part of an intervention aimed to     facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention     consist of a start package (iFOBT kits, a guideline and online educational material) that is     sent to GPs when they are included in the study, and a status mail that GPs receive approx.     one month after inclusion. The inclusion period is during the first 7 month of the study     period, the study lasts for one year.      Perspectives      This study will provide important knowledge on how to improve CRC diagnostics in general     practice.   "
74671|NCT02308371|"     Children who are critically ill often require large amounts of fluid during their acute     illness. It has been shown in multiple studies that appropriate administration of fluid     decreases morbidity and mortality, but giving too much fluid can also cause increased     morbidity and mortality. It is often difficult to discern from physical exam, vital signs and     labs if the amount of fluid that has been given is appropriate or if a pediatric patient     requires more fluid. Pulse pressure variation (PPV) is the change in blood pressure when a     patient is on a ventilator or breathing machine. PPV has been used in multiple adult studies     to help predict fluid needs in a critically ill patient. In this study, we would like to     investigate if PPV can help better predict if critically ill pediatric patients in the     pediatric intensive care unit (PICU) need fluid. The investigators hope that by having the     additional information that PPV can provide, physicians can more judiciously give fluid and     thereby improve morbidity of critically ill patients in the PICU.   "
74672|NCT02308358|"     The purpose of this study is to evaluate the functional and clinical outcomes of patients     receiving femoral condyle osteochondral allografts, to evaluate potential predisposing     factors to failure of such grafts, and to compare the overall outcomes of the grafts to the     current standard of care for smaller lesions, microfracture. Our hypothesis is that patients     treated with these allografts will demonstrate significant functional improvement as measured     by validated outcome scoring measures and their function will be at least equal to that of     microfracture outcomes.   "
74673|NCT02308345|"     Cancer patients about to begin chemotherapy receive large amounts of information regarding     their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the     chemotherapy during their first visit to the oncologist. Prior studies have documented that     less than half of this information is retained after the visit, making it difficult for     patients to participate in their care and difficult for them to enlist the help of their     social support. The MiVideo project allows the physician to create a custom 5-minute summary     video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. The     video will emphasize the major points of the forty-five minute office discussion, allowing     patients to review the physicians' recommendations and share the information and     recommendations with others. By providing the patient with this re-cap of their visit, the     investigators hope to engage them more actively in their cancer treatment. Making the     information available to friends and family can also help a patient receive both intellectual     and emotional support during the course of treatment. The primary endpoint of this study is     improvement of patient care, not research activity.      Primary Hypothesis: Creating a 5-minute video summarizing information about diagnosis, stage,     chemotherapy treatment plan, and anticipated side effects for patients starting chemotherapy     for colon cancer will not significantly lengthen the pre-chemotherapy clinic visit as     compared to visits that do not include video production.   "
74674|NCT02308332|"     This study will evaluate the effects of switching Atripla to Eviplera on neurocognition     measured by neuropsychological testing and functional MRI   "
74675|NCT02308319|"     Antiviral therapy for HBV may play an important role here, as a large observation study from     Taiwan reported that the use of nucleos(t)ide analogues (NUC) was associated with 33%     reduction in HCC recurrence. In the first randomized controlled trial evaluating the use of     NUC after surgical resection for HCC, NUC therapy was associated with better 2-year overall     (94% vs. 62%) and recurrence-free (56% vs. 20%) survival. However, patients with active liver     disease should be treated regardless of their impact on HCC recurrence (patients with high     serum HBV DNA and abnormal ALT). What is less clear is that whether patients with low level     HBV DNA, and normal serum ALT levels should be treated to reduce HCC recurrence.      In this trial, we will investigate to determine the efficacy of the treatment with Tenofovir     disoproxil fumarate (Viread(R)) as measured by the cumulative incidence rate of     hepatocellular carcinoma (HCC) at 3 year after curative treatment with radiofrequency     ablation (RFA) or surgical resection (SR) in chronic hepatitis B virus (HBV) infected     patients with low viral load.   "
74684|NCT02308202|"     The aims of this study is to determine the effects of treatment with doxazosin XL 16 mg/d     combined with virtual reality (VR) exposure therapy on Post Traumatic Stress Disorder.      The effects of treatment with doxazosin XL 16 mg/d combined with virtual reality (VR)     exposure therapy will be assessed in double-blind, placebo-controlled study. The study will     enroll 30 participants. The investigators will use a within groups design in which all     participants receive both placebo and doxazosin (N=16) with the order counterbalanced across     participants. A second group of patients (N=16) will receive both 16mg perindopril and     placebo instead of doxazosin/placebo.   "
74685|NCT02308189|"     A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow     restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and     endurance, whole body and regional lean mass and bone density, as well as the rate of     recurrence of LBP (secondary outcomes).   "
74676|NCT02308306|"     The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by     developing an implementable clinical computerised decision support system based on individual     patient characteristics.      The investigators hypothesize that successful pain control with opioids can be predicted     before treatment initiation with advanced data analyses of data originating from     pre-treatment EEG, QST and pain-related catastrophic thinking.      The primary objective of this study is the identification of markers that can be used to     individualize treatment recommendations, i.e. to reliably predict the response of pain to     opioids.      Markers are selected among the most promising data and machine-learning methods are used for     the prediction. This includes determining the associations between a battery of selected     pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in     opioid naïve chronic pain patients, including indication and responder identification.      The key secondary objectives are as follows: to investigate pre-treatment clinical predictive     markers as predictors of opioid treatment efficacy and effectiveness in terms of the     following:        -  Pain intensity and unpleasantness        -  Use of rescue analgesics        -  Physical functioning        -  Global improvement and satisfaction with treatment   "
74677|NCT02308293|"     Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people     with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation,     characterized by suppression of hypoglycemic symptoms, eventually leading to hypoglycemia     unawareness, which creates a particularly high risk of severe hypoglycemia. Recent evidence     suggest a pivotal role for (brain) lactate in the pathogenesis of hypoglycemia unawareness.     Indeed, exogenous lactate administration may preserve brain function and attenuate     counterregulatory responses to and symptomatic awareness of hypoglycemia. It is unknown     whether endogenous elevation of plasma lactate produces the same effects and whether such     effects differ between patients with T1DM with and without hypoglycemia unawareness and     healthy controls.      Objective: To investigate the effect of elevated levels of endogenous lactate on brain     lactate accumulation and on counterregulatory responses to, symptomatic awareness of and     cognitive function during hypoglycemia in patients with T1DM with and without hypoglycemia     unawareness and normal controls.      Hypothesis: The investigators hypothesize first that endogenous lactate, when raised through     high intensity exercise, preserves neuronal metabolism during subsequent hypoglycemia, which     in turn will attenuate counterregulatory hormone responses, appearance of symptoms and     deterioration of cognitive function. Second, the investigators posit that these effects will     be augmented in patients with hypoglycemia unawareness compared to healthy subjects and T1DM     patients with normal awareness as a consequence of greater transport capacity of lactate into     the brain.   "
74678|NCT02308280|"     Multiple myeloma is a morbid disease associated with a poor outcome, particularly those with     high-risk cytogenetics. While standard therapies have modestly improved survival in these     high-risk patients, myeloma remains incurable. To date, the only potential curative treatment     remains allogeneic hematopoietic stem cell transplantation. However, the high incidences of     toxicities including chronic GVHD and disease progression are currently the two most     important obstacles to this therapy. Better approaches to maintain and improve benefits of     allogeneic transplant, while decreasing toxicity, are urgently needed.      The investigators hypothesize that Bortezomib administration after non myeloablative     allogeneic hematopoietic stem cell transplantation in high-risk myeloma patients might     improved the outcome of these patients by decreasing myeloma relapse and the severity of     chronic GVHD while preserving the graft-versus-myeloma effect. Our goal is to improve the     poor clinical outcome of high-risk myeloma patients.   "
74679|NCT02308267|"     This project entitled Impaired secretory IgA and mucosal immunity in cystic fibrosis is a     research program which aims to determine, owing to national (KULeuven) and international     (Descartes university Paris, university of Torino) collaborations for expertise and access to     human material, whether a defect exists for the production of IgA antibodies in the lung from     patients with this serious genetic disease. These antibodies line and protect normally the     airways, and are secreted through a specific epithelial receptor called pIgR (polymeric     immunoglobulin receptor); its expression and regulation will be studied in lung tissue and in     cell cultures of the lung epithelium from these patients. The link between the putative IgA     defect and chronic bacterial infection with Pseudomonas aeruginosa, which often complicates     the evolution of the disease, will also be evaluated ex vivo and in vivo, in an animal model     of lung infection.   "
74680|NCT02308254|"     The purpose of this study is to determine the effects of the drug lixisenatide on blood sugar     levels, stomach emptying, blood pressure and heart rate, release of gut hormones and blood     flow in the gut after a glucose drink in both healthy subjects and people with type 2     diabetes. If lixisenatide is shown to be effective, it would encourage ongoing evaluation of     its potential use in the management of the falls in blood pressure following a meal in     diabetic patients.   "
74681|NCT02308241|"     The purpose of this study is to find out the effects, both good and bad, that a drug called     ribavirin has on the patient and the cancer.      Ribavirin has also been studied in clinical trials for patients with various types of cancer.     These studies demonstrated that ribavirin can be safely given at higher doses than the dosing     that is used as part of the treatment of hepatitis C.      Ribavirin is known to target a protein called 4E that turns on a central part which causes     the cell to grow, called the ribosome. HPV-related cancers often have abnormally high levels     of 4E. The purpose of this study is to evaluate if ribavirin may be a useful treatment for     patients with advanced cancers that are related to HPV by blocking the activity of 4E.   "
74682|NCT02308228|"     The purpose of this study is to determine whether a commonly prescribed drug, metformin, can     enhance the benefits seen during resistance exercise such as increased muscle mass and     strength.   "
74683|NCT02308215|"     The main purpose is to find a better way to predict the timing of treatments given to     patients with Wet Age-related macular degeneration using image analysis.   "
74701|NCT02307981|"     Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field     defects. Visual Field defects are negatively correlated to falling, institutionalisation,     rehabilitation outcome and quality of life. Patients are often not properly examined and     seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field     defects after occipital infarction and to determine whether rehabilitation is effective.   "
74686|NCT02308176|"     INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance     there is always a positive energy balance, with less energy expenditure than that obtained     from the intake. Low physical activity is often an important factor in this lower spending.     Medical advice is useful for determining changes in the habits of life of patients, however,     the changes produced by the council do not last over time, so it would be necessary to     establish enforcement mechanisms as with mobile technology, because it could improve the     adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of     an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to     lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open     randomized controlled clinical trial with clinical practice (health advice for physical     activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged     between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary     endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate;     Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of     physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm).     Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance     analysis adjusting by baseline weight, and other confounding variables (sex, age, level of     education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.   "
74687|NCT02308163|"     The objective of this study is to verify the superiority of ASP015K alone or in combination     with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in     patients with rheumatoid arthritis (RA) who had an inadequate response to DMARDs   "
74688|NCT02308150|"     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve     replacement (TAVR) in the Asian Pacific population   "
74689|NCT02308137|"     The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily     can prevent worsening of walking ability in people secondary progressive MS. The number of     participants in this study will be 62. A maximum of 75 people with secondary progressive MS     will be included. Each patient will be followed for 12 months from inclusion. Domperidone is     a medication which has been shown to increase levels of the hormone prolactin. The best     understood function of prolactin is the stimulation of milk production in women after     delivery. However, the increase in prolactin levels seen in patients treated with standard     doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical     symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore     may also improve myelin repair in people with MS. Domperidone is currently approved in Canada     to treat slow moving bowels and nausea, for instance in patients with Parkinson's Disease or     Diabetes Mellitus, where too slowly moving bowels can cause constipation. Domperidone is     available as a tablet that is usually taken four times per day. Doses up to 80mg per day may     be used but we estimate that a dose of only 40mg daily will be needed to stimulate myelin     repair. Domperidone is usually well tolerated.   "
74690|NCT02308124|"     Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic     hypotension and investigate the quality of life of treatment of neurogenic orthostatic     hypotension.   "
74691|NCT02308111|"     Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver     disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and     eventual cirrhosis requiring liver transplantation or resulting in death. The investigational     drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the     primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including     its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its     hepatoprotective effects and result in attenuation of injury and improved liver function in a     cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to     placebo, combined with stable standard care, on clinical outcomes in PBC patients.   "
74692|NCT02308098|"     The purpose of this study is to confirm equivalent bronchodilator efficacy of the test     product compared to the reference product.   "
74693|NCT02308085|"     The best available evidence suggests that pregnancy after breast cancer does not increase a     woman's risk of developing a recurrence from her breast cancer. In particular, the most     recent data suggest that this is the case also in women with a hormone receptor-positive     breast cancer. There is also no indication of increased risk for delivery complications or     for the newborn. The aim of the study is to investigate if temporary interruption of     endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of     breast cancer recurrence.The study aims also to evaluate different specific indicators     related to fertility, pregnancy and breast cancer biology in young women. A     psycho-oncological companion study on fertility concerns, psychological well-being and     decisional conflicts will be conducted in interested Centers.   "
74694|NCT02308072|"     The phase I trial aims to determine the recommended phase II dose (RP2D) and schedule of     olaparib in combination with standard cisplatin-based chemoradiotherapy, in patients with     high-risk locally advanced squamous cell carcinoma of the head and neck (HNSCC), by assessing     the safety and tolerability of the treatment combination.   "
74695|NCT02308059|"     The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in     people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with     clinical and demographic data.   "
74696|NCT02308046|"     The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the     treatment of vaginal infections   "
74697|NCT02308033|"     The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the     treatment of vaginal infections.   "
74698|NCT02308020|"     The main purpose of this study is to evaluate the safety and effectiveness of the study drug     known as abemaciclib in participants with hormone receptor positive breast cancer, non-small     cell lung cancer (NSCLC), or melanoma that has spread to the brain.   "
74699|NCT02308007|"     The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole     gel in the treatment of vaginal infections   "
74700|NCT02307994|"     The purpose of this study is to determine whether uFSH is effective and safe in the treatment     of male patients with severe oligospermia or azoospermia.   "
74704|NCT02307942|"     The main objective of this study is to compare the efficacy of two weight losing strategies     (obesity surgery with gastric banding, and standard of care) on physical performance in     elderly obese persons submitted to a physical training. Our hypothesis is that a     surgery-induced weight loss in the context of a physical training (which is recommended in     people 60-75 yrs losing weight) improves physical performance as compared to standard of care     (3-5% weight loss).   "
74705|NCT02307929|"     In the past two decades, as a result of population aging and shifts in patient needs, we have     seen an increased demand for chronic disease management (CDM) delivered in the community. The     Hong Kong Government introduced six nurse allied health clinics (NAHC) programme to assist     the delivery of care to facilitate the increased demand on chronic disease management (CDM)     in the community, which are currently being piloted within the government funded general     outpatient clinics (GOPC) of the Hospital Authority (HA). These programmes are designed to     enhance CDM in primary care through patient empowerment and use of multi-disciplinary nurse     and allied health led teams, and aim for secondary prevention and treat-to-target for     specific health conditions. This model of care has already been established in a number of     countries, namely United Kingdom, Australia, Canada and United States, where     multi-disciplinary allied-health clinics, nurse practitioners and nurse-led clinics have     already been integrated into routine practice in primary care (Thomas, Cullum et al. 2000;     Laurant, Reeves et al. 2005).      The six NAHC programmes which have been developed to date address falls prevention (FP),     continence care (CC), mental wellness (MW), wound care (WC), respiratory disease management     (respiratory clinic) and medication management and compliance (MMCC). The evaluation on the     QOC is an essential part of the programme in order to inform future policy. he Department of     Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been     appointed by the HA to carry out the evaluation of the QOC of the programme.      The Action Learning and Audit Spiral methodologies to measure whether the target standard of     care intended by the NAHC programme is achieved. Each NAHC participating clinic will be     invited to complete a structured evaluation questionnaire. Anonymized data of all patients     who have enrolled into the NAHC programme for more than 6 months will be included in the     evaluation on the process and outcomes of care. Data on the process of care will be retrieved     from the HA medical records.      In-depth study of NAHC CC programme: In order to compare the outcomes over time between     subjects who have and who have not participated in the NAHC Continence Care Programme, three     hundred and sixty control patients who have not been enrolled into the NAHC CC programme will     be selected for the comparison in the outcomes of care. Subjects will be followed up by     telephone to evaluate the effect of the programme in quality of life (QOL), patient     enablement, and global rating of change in health condition at baseline , 12-month and     24-month after enrollment.      Main Outcome Measures: The primary outcomes are the proportion of participants who have     received the planned process of care and have improvement in clinical outcomes.      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be     calculated. The changes in clinical, service and patient reported outcomes between baseline     and discharge will assessed by paired sample t-test. The audit cycle will be repeated 4 times     over a period of 5 years.      In-depth study of NAHC CC programme: the clinical outcomes between NAHC CC subjects and     control group will be compared by independent sample t-test or Chi-square test.      Results: The QOC of the NAHC programme will be determined. Areas of deficiency and possible     areas for quality enhancement will be identified.      Conclusion: The results of this study will provide empirical evidence on whether the HA's     NAHC programmes enhance the QOC of their participating patients. This information will be     used to guide service planning and policy decision making.   "
74706|NCT02307916|"     A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic     membrane as the primary measureable outcome. The goal is to determine the safety and efficacy     of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane     perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans,     it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic     membrane perforation. A total of 60 subjects will be recruited.   "
74707|NCT02307903|"     Patients with end-stage renal failure (ESRF) have lost the function to excrete urea and     maintain electrolyte balance, which is lethal unless they are given renal replacement therapy     (Gibney, Hoste et al. 2008). As one of the initiatives of service improvement, the HA has     introduced the haemodialysis public-private partnership (HD PPP) programme to shorten the     waiting time for patients with ESRF needing HD treatment. HD PPP programme is a new service     provision model that purchases healthcare services from non-Government healthcare     organizations. The evaluation on the quality of care (QOC) is an essential part of the     programme in order to inform future policy. The Department of Family Medicine and Primary     Care of the University of Hong Kong has been appointed by the HA to carry out the evaluation     of the QOC of the programme.      The Action Learning and Audit Spiral methodologies to measure whether the target standard of     care intended by the HD PPP programme is achieved. Each HD PPP participating hospitals and     centers will be invited to complete a structure evaluation questionnaire. Sixty patients who     have agreed to join HD PPP and 60 control patients who have refused to take part in HD PPP     will be included. The participants will be followed up by telephone to evaluate the effect of     the programme on quality of life (QOL), patient enablement, and global rating of change in     health condition. Data on the process of care and clinical outcomes of care will be retrieved     from the HA medical records.      Main Outcome Measures: The primary outcomes are the proportion of participants who have     received the planned process of care and adequate haemodialysis (HD) measured by the Kt/V      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be     calculated. The outcomes of HD PPP subjects will be compared at 6, 12, 24, 36 and 48 months     by paired sample t-test. The outcomes between HD PPP subjects and control group will be     compared by independent sample t-test or Chi-square test.      Results: The QOC of the HD PPP programme will be determined. Areas of deficiency and possible     areas for quality enhancement will be identified.      Conclusion: The results of this study will provide empirical evidence on whether the HD PPP     can achieve equivalent QOC as the usual HA care in order to guide service planning and policy     decision making for patients with ESRF.   "
74708|NCT02307890|"     Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation     but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one     or more bile ducts probably caused by inadequate blood flow or a failure of biliary     epithelium to regenerate. It typically presents weeks to months after liver transplantation,     is often refractory to treatment and can result in a requirement for re-transplantation.     Although IC is more common following DCD liver transplantation, it is otherwise very     difficult to predict and the underlying pathogenesis is poorly understood. The aim of this     study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile     duct biopsies taken during liver transplantation with the incidence of IC following liver     transplantation.   "
74709|NCT02307877|"     Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate     have not been examined in patients with relapsing forms of multiple sclerosis (MS). As     patients on long term therapy typically have little or no overt signs of white matter     inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into     whether there is continued progression of MS in these patients. What remains unknown is     whether patients on a particular therapy have a slower rate of brain atrophy. This would     provide convincing evidence that central nervous system tissue injury is further suppressed.     Such information would be of substantial clinical benefit when deciding between various     therapies.      The investigators will estimate the impact of long term use of fingolimod therapy (defined as     a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing     forms of MS as compared to age and gender matched patients on Glatiramer Acetate.      The investigators secondary goal is to determine the correlation between brain atrophy and     cognitive performance in treated patients with relapsing forms of MS.      The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL)     PROs, patient self-reports of disability, clinical assessment of physical disability, work     productivity, clinical assessments of cognitive functioning with whole brain volume loss for     patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and     gender.      The investigators anticipate the findings of this study will generate relevant hypotheses     about these relationships.   "
74710|NCT02307864|"     The purpose of this study is to assess the effects of multiple doses of an immediate release     (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels     in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart     rate (QTc).   "
74711|NCT02307851|"     The purpose of this study is to determine the immune response of three dose levels of the     Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four     treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups     A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will     receive a commercially available trivalent influenza vaccine (TIV). The study will also     evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.   "
74712|NCT02307838|"     This study collected follow-up data on approximately 90% of participants who were randomized     and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or     required. Participants were required to be assessed at one or two visits, preferably at the     original study site, but the option to be interviewed via phone or seen at home was provided.     Information was gathered also on deceased participants. Assessments were performed only once     within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple     Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale     (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).   "
74724|NCT02307682|"     The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT)     injection at two dosage levels to aflibercept solution for IVT injection (2 mg) in subjects     with untreated active choroidal neovascularization (CNV) secondary to age-related macular     degeneration (AMD) in the study eye.This study will be conducted in Argentina, Australia,     Brazil, Canada, Chile, Colombia, Costa Rica, Guatemala, Israel, Japan, Mexico, Panama, Peru,     New Zealand, and US (including Puerto Rico).   "
74713|NCT02307825|"     Justification: Chronic rhinosinusitis (CRS) is one of the most common inflammatory diseases     with an incidence and prevalence superior to 10%. Unfortunately, more than 30% of patients do     not respond to standard medical and surgical treatment, thus continuously increasing the     symptomatologic and socio-economic burden of this disease.      Hypothesis: The investigators believe that the addition of azithromycin (AZI) to the     treatment regimen of patients with refractory CRS failing conventional medico-surgical     treatment will be beneficial in a symptomatologic and endoscopic level.      Primary objective: 1- To evaluate whether Azithromycine 250 mg PO three times weekly is     effective in controlling signs and symptoms of CRS in high-risk patients unresponsive to     standard management after endoscopic sinus surgery (ESS) with budesonide irrigations.      Secondary objectives:      i) Validate a simple and concise treatment algorithm for patients refractory to standard CRS     treatment of ESS and BUDI, with the addition of low-dose AZI.      ii) Characterise and define the population deemed high-risk for standard CRS treatment     failure by evaluating: 1) demographics, 2) inflammatory states and 3) the nasal flora     microbiome of patients at the different follow-up points of this study.      iii) Explore the mechanisms of AZI by assessing the changes in inflammatory states and the     nasal flora microbiome associated with successful AZI therapy.      Methods: Inclusion of all patients admitted for endoscopic sinus surgery (ESS) for CRS     operated by the same surgeon (MD). Following their first postoperative visit (2 weeks), all     patients will receive nasal irrigations with budesonide (BUDI) twice daily for 4 months and     will be re-evaluated. If there is a failure of treatment, patients eligible to receive AZI     will be randomized in to two groups, AZI 250mg or a placebo three times a week for 4 months.     At every follow-up, complete endoscopic exams will be performed, along with sinus cultures     and brush cytology.      Population: All patients deemed high-risk with CRS admitted for ESS between October 2014     and October 2015.   "
74714|NCT02307812|"     The treating physician/investigator contacts Lilly when, based on their medical opinion, a     patient meets the criteria for inclusion in the ATU.   "
74715|NCT02307799|"     The aim of the RESPECT study is to gain a better understanding of the prevalence,     pathogenesis and symptoms of early chronic obstructive pulmonary disease (COPD). This study     seeks to address the following specific objectives/research questions: 1) to estimate the     prevalence of airflow limitation (AL) and COPD in adults 35-70 years of age in St.Petersburg     and Arkhangelsk based on sex, age, environmental conditions, socioeconomic status and smoking     status; 2) to compare the prevalence of COPD in the study population based on the Global     Strategy for Diagnosis, Management and Prevention of COPD (GOLD) and lower limit of normal     (LLN) criteria; 3) to identify the diagnostic value of various signs, symptoms and background     characteristics for the diagnosis of COPD; 4) to determine whether differences in background     characteristics and inflammatory biomarkers are evident between smokers with and without     COPD; and 5) to describe co-morbidity, functionality and global health status in a cohort of     newly diagnosed COPD patients.   "
74716|NCT02307786|"     Beta thalassemia (β-thalassemia) is the most common genetic disease worldwide. Individuals     with thalassemia are born with a defect in hemoglobin. Hemoglobin is a protein in red blood     cells that carries oxygen to vital organs such as the brain, heart, lungs and kidneys.     Thalassemia major is a hereditary anemia characterized by little or no ß-globin production,     which results in hemolysis (breakdown or destruction of red blood cells) due to the formation     of unstable alpha-globin tetramers and ineffective erythropoiesis which is uniformly fatal in     the absence of regular transfusions. Although improvements in conservative treatment have     improved the prognosis of thalassemia considerably disease and transfusion related     complications in affected patients progress over time, causing severe morbidity and shortened     life expectancy. Substantial lifelong health care expenses are also involved, often a     financial burden for families and unsustainable in most developing countries.      The hypothesis is that patients who had beta thalassemia who have undergone a hematopoietic     stem cell transplant (HSCT) and are >1 year post-HSCT will have less long term comorbidities     and a higher quality of life (QOL) as compared to those with beta thalassemia who are     maintained on supportive care. In order to assess quality of life, a quality of life     questionnaire will be asked. Extraction of data from the patient's medical record will also     be used to determine any comorbidities that have occurred after either a HSCT or supportive     care therapy.   "
74717|NCT02307773|"     The investigators tested whether a new method which additional lidocaine spray on the tip of     endoscope can increase the tolerance of examinee during endoscopy than conventional     pharyngeal anesthesia alone.   "
74718|NCT02307760|"     The purpose of this study is to assess growth of preterm infants fed human milk supplemented     with one of two commercially available human milk fortifiers.   "
74719|NCT02307747|"     Circadian rhythms, which play crucial roles in physiology, are emerging as important     regulators of specific immune functions. Hospitalization in intensive care unit leads to a     deep impairment of circadian rhythm. Infection is a frequent event during ICU     hospitalization.      The investigators hypothesis is that in trauma patients the lack of circadian rhythm     variations is associated with the occurrence of infection. The primary aim of the study is to     assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related     infection during the 30 days after inclusion. The secondary aims are to assess the plasma     expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines     in plasma, and the concentration of cortisol, according to the occurrence of an infection.   "
74720|NCT02307734|"     This project proposes two aims. The first aim is to evaluate the efficacy of a family-focused     intervention in promoting smoking cessation in Chinese and Vietnamese male smokers using a     2-arm cluster randomized controlled trial with assessments at baseline, 6, and 12 months     targeting 360 smoker-family dyads. Half of the participants will be assigned to the proposed     intervention, and the remaining half will be assigned to an attention-control condition where     they will receive education on healthy eating and physical activity. The second aim is to     explore mediators to identify key psychosocial and behavioral processes that underlie how the     intervention affects the processes of quitting and maintaining abstinence in Chinese and     Vietnamese smokers.   "
74721|NCT02307721|"     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least     in Norway. The annual death toll from overdose is about 250, higher than road traffic     accidents. Those who inject heroin or other opioids are considered to have the highest risk     for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as     naloxone is required. Usually naloxone is injected into a muscle or a blood vessel.     Administration of naloxone via the nose (intranasal) has been suggested as an alternative for     use by emergency teams and possibly also bystanders. This is not only an easier way to give     naloxone, but would also eliminate the risk for needle stick injuries and blood     contamination. In a series of studies on intranasal naloxone at The Norwegian University of     Science and Technology, this study explores pharmacokinetics and pharmacodynamics of     intranasal and intramuscular naloxone in healthy volunteers under the influence of     remifentanil.   "
74725|NCT02307669|"     The investigators hypothesize that aligning adherence with the patient's own clinical course     achieves better asthma control and identifies risks for future loss of control, compared to     current best practice. The study has an adherence optimisation phase, week 1-12 followed by a     medication management phase, week 12 to week 32.      The investigators will compare two asthma education interventions, standard Guideline     recommended practice and feedback from the individual's own INCA device, which assess inhaler     adherence and relates adherence with changes in PEFR and symptom scores over time.      The aim of the study is to then incorporate adherence into Guideline recommended medication     changes so that asthma control is improved and medication rationalised at the end of the     intervention.      A secondary aim is to assess the long-term effectiveness of this approach on control and     exacerbations.   "
74726|NCT02307656|"     The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat     (COBI) alone and in combination as well as oral test formulations containing both ATV and     COBI.   "
74727|NCT02307643|"     The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy     of MT-1303 in subjects with systemic lupus erythematosus   "
74728|NCT02307630|"     The purpose of this study is to find out how an antibody called Hu3F8 travels through the     body and to tumors. Antibodies, like Hu3F8, are proteins that help attack tumors or fight     infections. Antibodies can be made by your own body or in a laboratory. The target of an     antibody is called an antigen; antibodies fit their antigen like a lock fits a key.   "
74729|NCT02307617|"     The purpose of this study is to learn if measures of brain chemicals from a brain scan called     Magnetic Resonance Imaging and Spectroscopy (MRI/MRS) and brain activity (known as cortical     excitability and inhibition) collected by Transcranial Magnetic Stimulation (TMS) are     different in adolescents with depression who are in different stages of treatment.      Researchers are conducting this study to learn more about how the brain works in adolescents     with depression and without depression (healthy controls). This is important because it may     identify a biological marker (a measure of how bad an illness is) for depression that could     one day be used to identify depressed adolescents who would benefit from certain treatments     (medications for example) or to monitor how well treatments are working.   "
74730|NCT02307604|"     The SPECTAbrain protocol describes a structure for screening patients with brain tumors to     efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical     trials. Efficiency is promoted through the creation of a clinical database of brain tumor     patients and the respective human biological material biobank for molecular characterization.     The main objectives are to:        -  Allocate patients to clinical trials according to the clinical characteristics and          molecular profile of their tumor;        -  Identify or validate new molecularly defined subgroups of tumors;        -  Investigate the prevalence of novel biomarkers to plan future clinical trials;        -  Enable exploratory/future research;        -  Facilitate establishment of quality-assured and validated tests for Central Nervous          System (CNS) tumor biomarkers;   "
74731|NCT02307591|"     The purpose of this study is to evaluate the efficacy and safety of amiodarone in the     treatment of patients afflicted with Ebola virus disease.   "
74732|NCT02307578|"     The main objective of the Extended Access Program (EAP) is to ensure that subjects     participating in Study E2007-G000-332 continue to have access to perampanel until the time     perampanel becomes commercially available in the country in which they reside.   "
74733|NCT02307565|"     Following spinal cord injury autonomic regulation of the cardiovascular system is impaired,     which results in a variety of measurable abnormalities in blood pressure. Evidence of     causality has been documented in the general medical literature with findings of improved     cognitive function following acute increases in blood pressure using the anti-hypotensive     agent Midodrine Hydrochloride (midodrine). Additionally, a recent report documented an     inverse association between blood pressure and depression suggesting that low blood pressure     may confer greater risk than high blood pressure. Midodrine is a drug approved by the Food     and Drug Administration to treat low blood pressure in the general population. Midodrine is     not approved in the United States to treat low blood pressure in persons with spinal cord     injury. Therefore, its use in this study is investigational. The first objective is to     characterize the relationship between blood pressure, cerebral blood flow velocity and     cognitive function after a single dose of midodrine compared to placebo. Second objective is     to determine the long-term safety and efficacy of midodrine administration.   "
74734|NCT02307552|"     This study is being performed to verify the ability to use minimally invasive transurethral     ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral     ultrasonic prostate imaging, may in the future, be used for detection and monitoring these     disease processes to minimize the need for obtaining surgical biopsy specimens. The     hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging,     results in unique image signatures for identification of prostate cancer. This imaging     procedure provides a multifaceted view of the entire in-situ gland.      The current use of Prostate Specific Antigen (PSA) for determining the likelihood of presence     of cancer in the prostate gland requires interpretation and has a good but limited to predict     prostate cancer on biopsy, with significant false prediction rates. More importantly as a     blood test, the PSA test lacks the ability to pinpoint the location of the cancer within the     prostate gland. Preliminary study findings have suggested that Transurethral Ultrasonic     Scanning (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer     within the imaged prostate gland, and has the intrinsic capability to provide high resolution     images of the transverse and future three-dimensional views of the entire gland better than     currently used Transurethral Ultrasound (TRUS). Two important goals of the practicality of     this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to     directly detect prostate cancer locations in the prostate. 2. The use of TUUS to successfully     guide the prostate needle biopsy to cancer loci with a high rate accuracy.   "
74735|NCT02307539|"     This pilot clinical trial studies a palliative care program in improving the quality of life     of patients with newly diagnosed pancreatic cancer. Palliative care is care given to patients     who have a serious or life-threatening disease, and focuses on managing disease symptoms,     side effects of treatment or the disease, and improving patient quality of life. Studying a     palliative care program used for other types of cancer may help doctors learn whether it can     improve the quality of life of patients with pancreatic cancer.   "
74736|NCT02307526|"     Due to de-centralized cardiovascular control, persons with spinal cord injury (SCI)     experience blood pressure (BP) dysregulation which manifests in chronic hypotension with     exacerbation during orthostatic positioning. Although many individuals with SCI remain     asymptomatic to hypotension and orthostatic hypotension (OH), we recently reported reduced     memory and marginally reduced attention and processing speed in hypotensive individuals with     SCI compared to a normotensive cohort. Thus, we believe that treatment of overtly     asymptomatic hypotension and OH in the SCI population is clinically warranted. Currently the     FDA has approved only midodrine hydrochloride for the treatment of dizziness associated with     OH and proof of efficacy is limited. Acetylcholinesterase inhibition for treatment of OH is a     novel concept and has gained recent recognition in models of neurogenic OH (multiple system     atrophy; pure autonomic failure, diabetic neuropathy). The physiological rationale of this     concept is unique: acetylcholine (AcH) is the pre-ganglionic neurotransmitter of the     sympathetic nervous system. Inhibition of acetylcholinesterase will limit the breakdown of     AcH thereby facilitating vascular adrenergic tone and peripheral vasoconstriction.     Acetylcholinesterase inhibition has been reported to be efficacious in models of both     pre-ganglionic (multiple system atrophy) and post-ganglionic (pure autonomic failure,     diabetic neuropathy) origin and persons with SCI reflect a model of a preganglionic disorder.     In theory, if an individual has a complete autonomic lesion, acetylcholinesterase inhibition     would not be expected to improve orthostatic BP because little/no neural traffic would be     transmitted to the pre-synapse. However, individuals with an incomplete autonomic lesion may     benefit from this class of agent. Researchers are currently investigating the orthostatic BP     effects of acetylcholinesterase inhibition with pyridostigmine bromide (60 mg) in 10     individuals with SCI.   "
74737|NCT02307513|"     Behcet's disease, is a rare disorder that causes inflammation in blood vessels throughout the     body. The signs and symptoms of Behcet's disease may include mouth sores, eye inflammation,     skin rashes and lesions, and genital sores that vary from person to person and may come and     go on their own. The exact cause of Behcet's is unknown, but it may be an autoimmune     disorder, which means the body's immune system mistakenly attacks some of its own healthy     cells.      This study will test whether apremilast is better than placebo (inactive substance in the     same form as the drug) for the treatment of oral ulcers in subjects with active Behçet's     disease. Other manifestations of the disease will also be assessed, such as, pain and     tenderness in joints, eye inflammation, genital ulcers, and skin disease. This study also     will test how well the body tolerates apremilast.      This study is a randomized, placebo-controlled, parallel design. About 204 subjects will     participate. The placebo-controlled period will be 12 weeks long and patients will receive     apremilast or placebo. After the 12-week placebo-controlled period, all subjects will receive     apremilast for 1 year. All subjects will have their final study visit 4 weeks after stopping     apremilast treatment.   "
74738|NCT02307500|"     This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in     patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma     who have progressed after standard therapy.   "
74739|NCT02307487|"     A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is     designed to carefully assess the safety of successive cohorts of patients (3     patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical     instillations.   "
74740|NCT02307474|"     This pilot clinical trial studies the side effects of stereotactic body radiation therapy and     pazopanib hydrochloride in treating patients with kidney cancer who are not able to undergo     surgery. Stereotactic body radiation therapy is a specialized radiation therapy that delivers     high doses of radiation directly to the tumor and may kill more tumor cells and cause less     damage to normal tissue. Pazopanib hydrochloride may stop the growth of tumor cells by     blocking an enzyme needed for cell growth. Giving pazopanib hydrochloride before stereotactic     body radiation therapy may help make the tumor smaller and be an alternative treatment for     patients who cannot undergo surgery.   "
74741|NCT02307461|"     To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on     the Pharmacokinetics of IPI-145   "
74742|NCT02307448|"     This investigation plans to initiate the healing of chronic wounds by providing a     concentrated platelet and growth factor therapy directly to the wound site by topical     delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an     emerging surgical and wound care treatment. This investigation aims to demonstrate that     patients with chronic, non-healing wounds treated with autologous PRP and standard medical     care have a reduction in wound volume and improved healing rate that results in     patient-centered clinically significant health outcomes as compared to patients treated with     standard medical care only.   "
74743|NCT02307435|"     Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue.     Although MSC derived from autogenic bone marrow are proven to help regeneration in non union     fracture and long bone defect, the aspiration process through iliac crest is invasive and     painful.      Therefore, alternative source of MSC which is less invasive is needed. Adipose and umbilical     cord is a waste product that proven to contain enormous MSC. Furthermore adipose and     umbilical cord as an allogenic source is more abundant in number compares to autogenic bone     marrow. This enormous source need and adequate preservation technique before applied to the     patient. According to that, researchers want to explore the potency of MSC from bone marrow,     umbilical cord and adipose as the source of allogenic MSC and the effect of cryopreservation     technique to the viability and quality of MSC. We will also compare the effectivity of MSC     implantation from bone marrow, umbilical cord and adipose applied to non union fracture and     long bone defect.      Samples from bone marrow, umbilical cord and adipose are cultured and the viability of the     cells are observed. Some of the cells are implanted directly to the patient with non union     fractures and long bone defect while some are cryopreserved in liquid nitrogen -190 degree     Celsius in three months. All samples are thawed and the viability of the cells are observed.     Patient who are implanted by MSC allogenic will undergo clinical and radiological examination     in the third, sixth and twenty second month after implantation.   "
74744|NCT02307422|"     The design and purpose of the current study is to expand and validate previous findings that     the IL-1 gene cluster composite genotype patterns potentiate the risk for coronary artery     disease (CAD) and cardiovascular events mediated by OxPL and Lp(a). A secondary objective is     to validate other, non IL-1 genetic variants associated with CAD.   "
74758|NCT02307240|"     This is a Phase I, open-label, multi-center trial designed to evaluate the safety,     tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with     advanced/relapsed solid tumors.   "
74802|NCT02306668|"     The investigators seek to characterize the identity of all microorganisms residing on the     eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a     combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the     vast majority of cases the cause of the chronic inflammatory condition is unknown.   "
74803|NCT02306655|"     Fundamentals of scientific research The coital incontinence (IC), defined as the     involuntary loss of urine in association with sexual intercourse. The incidence reported in     the literature ranges from 10% to 27%, but is likely to be underestimated because of the     embarrassment of the woman to report the disturbance. It was in fact estimated that only 3%     of women speaks spontaneously to their doctor, and increases up to 20% only after a request     by the medical staff.      The CI is traditionally divided into two forms:        1. incontinence at the time of penetration (60% of cases)        2. incontinence during orgasm (40% of cases) Many theories have been proposed to justify          this form of urinary incontinence, but none has been conclusively proved .Moreover, it          has not been possible, to date, to identify risk factors, anatomical or urodynamics, for          this condition.      The IC is rarely a symptom isolated, but more frequently associated with other forms of     urinary incontinence. In particular, the IC during penetration of associated with stress     urinary incontinence (loss of urine that occurs due to coughing, sneezing and in general to     all those activities that increase abdominal pressure); the IC during orgasm is associated     more frequently to a condition of overactive bladder (presence of urgency, urge incontinence,     increased urination day and night).      The IC has a strong impact on female sexuality and can cause loss of libido, non orgasmic,     decreased sexual satisfaction and, in some cases, termination of sexual activity.      Research goals Evaluate a prospective investigation of health statistics, the incidence of     coital incontinence into consideration that there are few data in the literature on this     disorder and those who have reported a wide variance probably connected to how the data     collection. The aim is to be able to identify a threatening condition which, if not     evaluated, worsens the prognosis of the treatment of female urinary incontinence, a condition     that has a negative impact on the quality of life of patients with significantly worse than     that related to other recognized debilitating chronic diseases such as diabetes.      And this individual psychosocial cost, hardly quantifiable, must be added the cost of     significant socio-economic and welfare dependents of incontinent patients, the community and     national health services. It is indeed evident from international and national literature     that the more incisive and determined is the strategy of information, awareness and     education, and adopted much wider and earlier the diagnosis, the more significant is the     socio-economic savings, as well as psycho social, we get.      Ultimate goal is to differentiate between them the two forms of incontinence coital (to     penetration and during orgasm) because each of them is associated with pathogenesis and     therefore to a separate treatment. And while the forms of IC penetration favorably affected     the treatment of stress urinary incontinence, the forms of IC during orgasm, usually     associated with a functional disorder of the detrusor (detrusor overactivity) show an     inferior efficacy to treatment antimuscarinic traditionally reserved to the condition of     overactive bladder and therefore need a more targeted diagnostic and individualized     treatments.      Materials and methods      Self administered questionnaires will be dispensed to the patients The     questionnaires,validated in Italian language, will be used, according to the guidelines of     the International Consultation on Incontinence, :        -  ICIQ-UI on urinary incontinence short-form: for the evaluation of symptoms and quality          of life:        -  Patient Perception of Bladder Condition (PPBC): to assess the impact of such a          subjective condition;        -  Urinary incontinence and quality of sexuality;        -  Urinary incontinence and frequency of sexual activity; The questionnaire is anonymous in          order to protect privacy. The patients will be recruited at the outpatient surgery and          Urogynaecology urodynamics of Urology Clinic of the University of Perugia.      The investigators defined that the statistically significant number of subjects can not be     less than 200 units.      The time duration of the collection of medical records was estimated at two years.      There are no extremes of the conflict of interest, will not be tested or used drugs or     medical equipment.   "
74745|NCT02307409|"     This study attempts to clarify the pathophysiology of haemostasis and haematopoiesis in     relation to the evidence of sepsis in liver disease, and compares the accuracy of various     available laboratory tests in assessment of these patients. Further research is needed for     proper understanding of the influence of sepsis on coagulation disorders in ACLF (Acute on     Chronic Liver Failure) patients in particular, to correctly identify the type and optimal     quantity of blood product requirement in at risk patients.      Thromboelastography (TEG) /Sonoclot have been proposed as a superior tool to rapidly diagnose     and help guide resuscitation with blood products. Secondly, the study of derangement in     coagulopathy after the onset of sepsis is of paramount importance because of increased     mortality after the onset of sepsis. In the present study, patients with ACLF (Acute on     Chronic Liver Failure) without evidence of sepsis on admission will be included in the study     cohort, and will undergo a baseline diagnostic workup as described. They will be followed for     development of any signs of infection after hospitalization. Then the effect of sepsis on     their coagulation and haematopoietic cellular responses will be assessed. Thus the effect of     sepsis on the progression and outcome of patients with ACLF (Acute on Chronic Liver Failure)     will be studied.   "
74746|NCT02307396|"     The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention     should be continued and to which time a patient with schizophrenia is protected enough, so     that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as     primary outcome.   "
74747|NCT02307383|"     The combination of Lactitol and Probiotics (Lactobacillus acidophilus and Lactobacillus     Biphidus) administered orally is an effective strategy of intestinal decolonization of     Enterobacter produced OXA-48-type carbapenemase.      The purpose of this study is to determine the effectiveness of Lactitol and Probiotics for     the intestinal decolonization of people who carried Klebsiella pneumoniae produced     OXA-48-type Carbapenemase.   "
74748|NCT02307370|"     The primary objective for this study is to prove the safety and effectiveness of the     Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with     catheter to vessel sizing of at least 50%.   "
74749|NCT02307357|"     Habitual physical activity was found to be positively related to better health and     well-being. One of the most popular physical activity forms is ball games. In Israel, there     is a growing popularity in a new ball game - Newcomball - which is being played by many     middle age, non-athlete, women. However, so far, no study had evaluated the contribution of     the game to improvement in the participants' physical fitness. The aim of this study,     therefore, is to evaluate the effects of six month two weekly Newcomball training sessions to     the physical fitness of middle age women.   "
74750|NCT02307344|"     The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic     Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.   "
74751|NCT02307331|"     The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem     used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom     polyethylene, and OptiPac/OptiVac bone cement mixing systems.   "
74752|NCT02307318|"     A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal     hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated using     4 French radial sheath. There was no evidence of radial artery occlusion in this small sample     and bleeding was limited to grade 1. This evidence supports a larger retrospective study to     confirm these results and define an alternative to the TR band use post radial artery access     for cardiac catheterization.      Primary Objective Determine the incidence of arterial bleeding after real-world use of     SoftSeal hemostatic device at a transradial access site with a 4 French system with with     manual pressure by compression of the ulnar artery.      Secondary Objective Determine the incidence of thrombosis at the access site in all subjects     as presence of thrombus in the radial artery by reverse barbeau test; the incidence of     changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted     hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.   "
74753|NCT02307305|"     Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause     impairment in quality of life and functional capacity after total knee arthroplasty(TKA).     Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown     to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and     spinal cord are believed to both mediate core mood symptoms and help regulate the perception     of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain     perception, may be due to increasing the activity of serotonin and norepinephrine in the     central nervous system. Approved for the acute and maintenance treatment of major depressive     disorder, the acute treatment of generalized anxiety disorder, the management of diabetic     peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).      Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with     those in non-duloxetine group (n=84). Investigators will classify the participants in to 2     groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of     neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6     months). All participants will receive postoperative pain control after TKA using the same     pain control regimen except duloxetine.   "
74754|NCT02307292|"     This is a prospective, non-randomized post market surveillance registry designed to document     the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self     Expanding Stent System   "
74755|NCT02307279|"     This study will asses the decrease in body weight after repeated administration of Gelesis100     in overweight and obese subjects with and without Type 2 Diabetes.   "
74756|NCT02307266|"     This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The     main objective of this study is to evaluate the effect of a supplementary patient education     intervention (in addition to the standard-of-care patient education) on treatment adherence     and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary     care clinics.   "
74757|NCT02307253|"     This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in     nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the     acquisition of samples for histologic analysis. Patients with lesions that can be approached     only from the duodenum will be prospectively enrolled.   "
74759|NCT02307227|"     Prospective, monoinstitutional, phase II study. Patients with HER 2 positive locally advanced     breast cancer will be treated with 3 initial cycles (12 weeks) of trastuzumab plus paclitaxel     and then if responding further 12 weeks and then with surgical resection, patients with HER2     negative breast carcinoma will be treated with 4 cycles (12 weeks) of epirubicin and     taxotere. If responding 4 more cycles (12 weeks). Patients progressing will be treated     depending on physician's and patient's preference   "
74760|NCT02307214|"     Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and     chronic cardiac conditions whose clinical presentation, mimicking the onset of acute     myocardial ischemia in absence of epicardial coronary disease, has progressively gained the     interest of the scientific community. However, despite significant progress, their underlying     pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial     dysfunction and autonomic imbalance have both been individually implied in their puzzling     pathogenesis.      The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and     healthy volunteers with the following primary objective: to assess the response of     endothelial function (through the Endopat score) to the autonomic tone activation induced by     a 10-minute stress mental test. The assessment of autonomic tone during activation through     the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with     endothelial function (Endopat score) will represent secondary objectives.      Our study will enroll 15 patients with TTC at least six months after the event, 15 patients     with classic CSX and 15 healthy volunteers who will serve as control.   "
74761|NCT02307201|"     There is no evidence that patients receiving magnesium sulfate before birth are required to     maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical     study in patients with severe preeclampsia who have been treated with impregnation of     magnesium sulphate and at least eight hours have received the drug before birth. If the     patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours     postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other     anticonvulsant drugs. This study can be conducted in 12 maternity latin america.   "
74762|NCT02307188|"     This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the     left and right atria to explore atrial signal characteristics that can guide atrial     fibrillation and atrial flutter ablation procedures more effectively.   "
74763|NCT02307175|"     Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m     pertechnetate produced by high energy cyclotron at CHUS.   "
74764|NCT02307162|"     The purpose of the study is to assess the safety of single doses and multiple doses of a new     formulation of RPL554 in healthy subjects and subjects with chronic obstructive pulmonary     disorder.   "
74765|NCT02307149|"     Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma     patients.   "
74766|NCT02307136|"     This multicenter cohort aims to assess the impact of within-hospital trajectories of patients     admitted in intensive care units from emergency departments on vital prognosis of patients,     duration of hospital stay and hospital costs.      As secondary objectives, the study will:        -  assess the impact of clinical and demographic characteristics on hospital trajectories          of patients.        -  assess the impact of emergency units workload, beds availability in medical units and in          intensive care units, and global hospital organisation on patients care trajectories.   "
74767|NCT02307123|"     The primary aim of this study was to describe the long-term outcome of critically ill or     severely injured patients not in cardiac arrest treated by an EMS physician.   "
74768|NCT02307110|"     This study is designed to evaluate the prevalence of different stages of diabetic retinopathy     and diabetic macular edema among patients suffering from type 1 diabetes (DM 1) for 5 to 25     years and have been treated with intensified insulin therapy aiming near-normal blood glucose     levels for the whole duration of disease.      Prevalence of different stages of diabetic retinopathy and diabetic macular edema is assessed     using the modified Airlie House classification and the Early Treatment Diabetic Retinopathy     Study (ETDRS) retinopathy severity scheme. Results of this study will provide the basis for     designing further studies as well as staging and screening guidelines for diabetic     retinopathy/diabetic macular edema.   "
74769|NCT02307097|"     The efficacy of high-intensity Cognitive-Behavioural Therapy (CBT) for social anxiety     disorder is well established (Mayo-Wilson et al., 2014) and it is recommended by the National     Institute of Health and Clinical Excellence (NICE) as the first-line psychological     intervention for social anxiety disorder. The treatment aims to modify several maintenance     factors (e.g., self-focused attention) that are specified in cognitive models of social     anxiety disorder (e.g., Clark & Wells, 1995).      Cognitive-behavioural self-help treatments for social anxiety disorder have been developed to     overcome various accessibility issues (e.g., long wait-lists, and the patient's need to avoid     social situations, etc) associated with high-intensity CBT (Abramowitz et al., 2009;     Carlbring et al., 2007) but a recent network meta-analysis (Mayo-Wilson et al., 2014)     identified the former as less cost-effective than the later and thus, they are not     recommended as standalone treatments.      However, the potential benefit of cognitive-behavioural self-help treatments for social     anxiety disorder within a stepped-care recovery model as a prelude to high-intensity CBT has     not been formally evaluated.      The aim of this study is to evaluate a seminal Cognitive-Behavioural Bibliotherapy* (CBB;     pure self-help book) - 'Overcoming Social Anxiety & Shyness' (Butler, 2009) - for patients     with social anxiety disorder while on the wait-list for high-intensity CBT within an     Improving Access to Psychological Therapies (IAPT) service, and to determine if some patients     recover from CBB alone or whether there may be a reduction in the average number of     high-intensity CBT sessions for those patients who subsequently require further treatment.      The study is funded by Constable & Robinson, Kellogg College (University of Oxford) and     Talking Change (Solent NHS Trust).      * The Reading Well Books on Prescription scheme with funding from the Arts Council England     enables general practitioners (GPs) and mental health professionals to prescribe seminal CBBs     for patients with mood and anxiety disorders. The books are accessed free of charge via local     libraries. The scheme works within NICE guidelines and it is support by the Royal Colleges of     GPs, Nursing and Psychiatrists, the British Association for Behavioural and Cognitive     Psychotherapies and the Department of Health through its IAPT programme.   "
74770|NCT02307084|"     The long saphenous vein is traditionally harvested for use as a conduit in coronary artery     bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery.     This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to     improve patient and clinical outcomes.   "
74771|NCT02307071|"     This study evaluates the effect in chronic migraine patients of daily 20     minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.   "
74786|NCT02306876|"     This study is designed to investigate the safety, tolerability pharmacokinetics and     pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets     in healthy adult males.   "
74772|NCT02307058|"     The BLaStM clinical trial extends the Phase I LEAD trial and compares the LEAD upfront     technique for increasing dose to the MP-MRI defined GTVs to the HEIGHT method of using a     moderate hypofractionated simultaneous integrated boost to the MP-MRI defined GTVs through     the course of radiotherapy. The hypothesis is that alternate mechanisms of cell death,     including bystander effects, are put in place when doses above 8 Gy per fraction are used in     a lattice and that the effects on local tumor eradication will be greater using this     strategy.   "
74773|NCT02307045|"     The integrity of endothelial glucocalyx plays a vital role in vascular permeability and     inflammation. Smoking cessation is related with improved vascular function and is a key     component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of     evidence based smoking cessation treatment. This study was designed to determine the effects     medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking     cessation programs   "
74774|NCT02307032|"     Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence     increases significantly after 80 years of age. After the appearance of first episode(s) some     of the patients will present frequent arrhythmia recurrences moving from the paroxysmal     status to the persistent and the permanent status of the continuous spectrum of the natural     time course of AF. In contrast some other will not present further relapses. To study and     predict the dynamic evolution of AF is clinically important, furthermore, the detection of     different sub populations risk for AF relapses will determine and different therapeutic     approaches.   "
74775|NCT02307019|"     The purpose of this study is to analyze the effects of a intervention on a specific health     prevention/intervention program aimed at caregivers of mild and moderate patients post stroke     with upper limb apraxia in comparison to a control group with a no specific formation in that     kind of patients.   "
74776|NCT02307006|"     The study is a randomized double-blinded study comparing ceftaroline to standard of care     therapy with cefazolin and vancomycin as surgical prophylaxis for high risk orthopedic and     cardiac surgeries. Study participants will be enrolled from those undergoing cardiothoracic     surgery involving sternotomy and those undergoing prosthetic joint replacement of either hip     or knee. Consenting patients will be randomized 2:1 to receive either ceftaroline or     cefazolin/vancomycin. This study will be blinded by the use of placebo vancomycin infusions     and placebo cephalosporin infusions. The primary end point will be the development of a     surgical site infection within 30 days of surgery.   "
74777|NCT02306993|"     This research study has two purposes. The first purpose is to determine whether having sickle     cell trait (SCT) is a risk factor for the development of bone thinning at an earlier age than     expected. Nearly 10% of African Americans (AA) carry sickle cell trait and most of them are     unaware of it. African Americans are less likely to develop thin bones than whites, but if     they sustain a bone fracture, they are more likely to die from it. We believe having sickle     cell trait may lead to bone thinning and predispose a subset of African Americans to     dangerously thin bones. The second purpose is to try to understand why individuals with     sickle cell disease (SCD) have thinner bones than healthy individuals do. Doctors have     already discovered that people with sickle cell disease have very thin bones, but they have     not determined why. Our study will try to identify whether the bone thinning is from the body     not making enough bone or from the body losing bone once it is made.   "
74778|NCT02306980|"     Oropharyngeal administration of mother's colostrum to premature infants has been proposed as     a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and     sepsis, particularly in intubated babies. We propose to study the impact of this intervention     on the composition of the oral microbiota.   "
74779|NCT02306967|"     Studies from Vancouver show that fluorescent visualization (FV) is a useful method of     controlling surgical margins. This early finding will now be confirmed in a national     randomized controlled trial.   "
74780|NCT02306954|"     All patients will receive IL-2 (14 planned doses with an additional cycle 14 days after the     first). Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.     Patients assigned to SBRT arm will receive two doses of SBRT on the Wednesday and Friday     before the Monday on which IL-2 starts.   "
74781|NCT02306941|"     This pilot-study aims to evaluate the treatment effects and feasibility of an     internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and     functional dyspepsia.   "
74782|NCT02306928|"     Antibiotic dosing in septic shock patients poses a challenge for clinicians due to the     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.      We determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 15 patients     treated empirically for septic shock. A PK population model was established with the dual     purpose to assess current standard treatment and to simulate alternative dosing regimens and     modes of administration. Time above the minimal inhibitory concentration (T>MIC) predicted     for each patient were evaluated against clinical breakpoint MIC for Pseudomonas aeruginosa     (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T>MIC and     50% fT>4xMIC.   "
74783|NCT02306915|"     Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian     participants for the sake of matching. Every effort will be made to match Caucasian and     Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to     maintain balance between male and female participants within the cohorts. There will be no     replacement of participants following randomization.   "
74784|NCT02306902|"     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,     two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules,     USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules     130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient Pharmaceuticals     Corp. Waltham, MA 02451 in healthy, adult, male, human subjects under fed condition.   "
74785|NCT02306889|"     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,     two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate     capsules, USP 130 mg, of Ohm Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceutical     Inc.) with Antara® (fenofibrate) Capsules 130 mg of Oscient Pharmaceuticals Corporation USA,     in healthy, adult, male, human subjects under fasting condition.   "
74788|NCT02306850|"     This study is being done to see if using the study drug, pembrolizumab, can shrink down     melanoma tumors enough so that they will be small enough to cut out, so that there will be no     cancer left in the body.      Eligible participants include those who have not received any systemic melanoma therapies     (i.e. participants do not have to fail ipilimumab or BRAF inhibitor) and those who have     failed all available systemic options (if the participant meets other inclusion / exclusion     criteria).   "
74789|NCT02306837|"     To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical     trial to test the efficacy and feasibility of consolidation chemotherapy after autologous     stem cell transplantation   "
74790|NCT02306824|"     Investigator-initiated prospective multicentre hospital-based registry to uncover the     proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and     assessing the proportion of stroke, intracranial bleeding and all-cause death in the short     (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic     stroke or transient ischemic attack in an unselected urban population in Germany.   "
74791|NCT02306811|"     Primary Objective:      To assess the long-term safety of vatelizumab in MS patients      Secondary Objective:      To assess the long-term efficacy of vatelizumab   "
74792|NCT02306798|"     This is a Phase I, open-label, single-site trial to evaluate the drug release, using     scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9]     subjects will be evaluated. The subjects will receive one [1] radio-labelled tablet after a     high fat and a rich in calories breakfast.   "
74793|NCT02306785|"     This is a Phase I, open-label, single-site trial to evaluate the drug release, using     scintigraphic images and mesalazine plasma levels (PK) in healthy subjects and patients with     mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be     evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1]     radio-labelled tablet of either formulation D or formulation E, respectively.      Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects     and five [5] patients will be administered one [1] radio-labelled tablet of this new third     improved formulation H.      In order to keep the number of patients low, recruitment of patients will be stopped when     obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will     then be recruited to achieve a full set of participants (n=9 per Arm).   "
74794|NCT02306772|"     This is a Phase I, open-label, single-site trial to evaluate the drug release, using     Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9]     subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be     assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive     formulation B and the second 9 subjects will receive formulation A. The subjects will be     treated once with the radio-labelled study medication.   "
74795|NCT02306759|"     The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine     versus morphine alone for acute generalized pain in the Emergency Department (ED). The     investigators are also interested to investigate whether low-dose ketamine is a safe and     effective alternative option to opioids for the acute treatment of pain in the Emergency     Department.      The agents that are available in the department includes acetaminophen, non-steroidal     anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not     adequate to manage acute pain crisis. There is also heightening concerns for increased opioid     use or abuse by patients. Since the HCAPHS survey includes various questions which inquires     about patient perception of pain management in the department, the investigators are     interested in investigating the safety and efficacy of low-dose ketamine to as an alternative     method to opioids for the acute management of pain. There has been limited, mostly     observational pilot studies, published in the literature. Limited data in the literature have     reported the incidence of nausea and vomiting ranged from 3-13%. All published literature     administered low-dose ketamine as an intravenous push. To the best of our knowledge our study     would be the first study to administer low-dose ketamine as a short bolus infusion to     mitigate the incidence of nausea and vomiting. The investigators believe our study would     provide important scientific data to fill the theoretical gap that low-dose ketamine at     0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is     located in the center of a densely populated urban area.   "
74796|NCT02306746|"     Nutrition therapy is an essential standard of care for all critically ill patients who are     mechanically ventilated and remain in the intensive care unit for more than a few days.      The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial     to determine if augmentation of calorie delivery using energy dense enteral nutrition in     mechanically ventilated patients improves 90 day survival when compared to routine care.   "
74797|NCT02306733|"     200 women with PPH will be randomly divided into 2 equal groups using computer generated     random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland)     and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The     investigators will not include a control group for ethical reasons.   "
74798|NCT02306720|"     To collect and evaluate long-term safety and effectiveness data in HPP patients who have/ are     receiving treatment with asfotase alfa.   "
74799|NCT02306707|"     A patient referred to have a lesion in the stomach removed. The aims of this study are to     collect information on the technique of endoscopic removal of such lesions. By collecting     information on a large number of patients undergoing this procedure the investigators can     determine the best ways of diagnosing and removing these lesions safely and effectively.   "
74800|NCT02306694|"     One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture     outcome data demonstrating the clinical significance of decreased BMD and altered bone     biomarkers in the hemophilia population. This study demonstrates that PwH have an increased     risk of fracture compared to the general population and that the issue of bone health will     increase in importance as the PwH population ages.   "
74801|NCT02306681|"     This study is conducted globally. The aim of this study is to describe the proportion of     patients with hypoglycaemic episodes and estimate the incidence of various types of     hypoglycaemia in the retrospective and prospective periods.   "
74804|NCT02306642|"     The purpose of this study is to learn more about how to identify signs of early chronic     kidney diseases in children who were born prematurely with low birth weight (less than 3 ½     pounds). Researchers plan to compare the kidney function in children who experienced acute     kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not     experience it. Evidence from several studies and our experience at UVA show that older     children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased     risk of developing early chronic kidney disease, and they also show early changes in the     urine and blood that is consistent with early chronic kidney disease. In this study, the     investigators hope to determine if any of these changes can be detected in early childhood,     and if so, at what age we can start detecting these changes.   "
74805|NCT02306629|"     To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety     and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to     when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.   "
74806|NCT02306616|"     To develop and implement quality improvement programs for the treatment of acute coronary     syndrome (ACS) in China based on the successful experience of the AHA-Get with the Guidelines     program. This two-year program will use data collection, analysis, feedback, and process     improvement to extend the use of evidence-based guidelines throughout the healthcare system     and improve patient care of acute coronary syndrome.   "
74807|NCT02306603|"     This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in     the duodenum and ampulla'. The research project is aiming to determine the most effective and     safe way to remove such lesions.   "
74808|NCT02306590|"     The primary objective of the trial is to investigate the survival time (the time from     randomization until death or date of end of the study) compared between control group and     experimental group.      This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind     trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg     riluzole in amyotrophic lateral sclerosis (ALS) in 200 enrolled patients. For entry, the El     Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on     riluzole at least 4 weeks prior to randomization.   "
74809|NCT02306577|"     The SINNR study will evaluate the virologic efficacy (viral load <50 copies/mL)and safety of     STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users.   "
74810|NCT02306564|"     The purpose of this study is to determine the effect of giving cabergoline to patients at     risk of OHSS (ovarian hyperstimulation syndrome) after ovum pick up, on endometrial     vascularity and it's effect on pregnancy outcome   "
74811|NCT02306551|"     The purpose of this study is to establish a cohort of pregnant women with severe mental     disorder and to identify biological and psycho-social transmission mechanisms involved in the     development of 'risk' and 'resilience' in the offspring. It is assumed that both 'resilient'     and 'risk' development in offspring are caused by a complex interaction between multiple     biological, psychological and social factors. The project focuses specifically on exploring     the impact of physiological stress-sensitivity, attachment, care-giving and the familial and     social context for care-giving. Previous studies support these factors as important for the     development of these infants, but systematic research using a prospective design is needed to     strengthen evidence and elucidate the importance of these factors in more detail. The     interaction over time of physiological stress-sensitivity, attachment, care-giving and the     familial and social context for care-giving are evaluated in terms of the evolution of very     early indicators of developmental risk and resilience in infants with a known highly     increased risk for developing a mental disorder.The findings of the study may potentially     lead to more specific targets for preventive interventions, which can improve developmental     outcome for these infants.   "
74812|NCT02306538|"     Breast cancer is the most common cancer amongst Canadian women. 15-20% of early breast     cancers have high levels of a protein called HER2 which is associated with worse survival.     Treatment of these patients with anthracyclines followed by trastuzumab (which targets HER2)     improves survival. Unfortunately, these medications together can cause heart muscle injury     resulting in heart dysfunction or failure in about 14% and 3.6% of the patients,     respectively. Once heart failure (HF) occurs, about 60% of patients will not live past 2     years. Studies have suggested that patients with heart injury caused by anthracyclines may be     more likely to develop HF with addition of trastuzumab. Therefore tests to find early heart     injury after anthracyclines may allow doctors to start heart protective medications with the     hope of preventing HF. Also, animal and small patient studies have shown that an increase in     the water levels of the heart muscle (edema) may be an early sign of heart injury from     anthracyclines. Cardiac MRI is a unique technique that has been shown to detect edema in     various heart diseases.      The investigators will test the theory that, in women receiving treatment for breast cancer,     heart edema detected by MRI at the end of anthracyclines will identify patients who will     later develop heart dysfunction. MRI studies with novel techniques will be done pre-therapy,     after anthracyclines, during herceptin, and at end of all therapy. The investigators will     compare patients with and without heart dysfunction to test if patients with heart     dysfunction are more likely to have edema after anthracyclines. Ultimately the investigators     hope to use cardiac MRI to identify high risk patients and study various heart protective     medications to prevent HF. This will improve the personal health of cancer patients by     allowing them to live free of heart disease after their cancer therapy. Ultimately at a     population level this will allow doctors to provide care that can be uniquely designed for     each patient based on their individual risk.   "
74813|NCT02306525|"     Purpose: The aim of this prospective cohort is to evaluate patients before, 6 and 12 months     after arthroscopic surgery for FAI and compare the results to people without hip problems.      Methods/design: Sixty patients with FAI and 30 persons without hip problems will be included.     Pre- and postoperatively, patients will be evaluated by CT-scans. All participants will have     their hip flexor and extensor muscle strength assessed and have performed kinetic and     kinematic analyses of daily activities with 3D motion capture. Further, self-reported     questionnaires on hip related pain, quality of life and sports activities will be collected.     Finally, participants will have their daily physical activity monitored with tri-axial     accelerometers for five consecutive days.      Perspectives: With this prospective cohort study the outcome of arthroscopic treatment of FAI     within one year after surgery will be evaluated. If the patients fail to reach reference     values one year after surgery, altered surgical procedures or rehabilitation programs to     optimize treatment for the patients may be explored in future studies. Further, the     investigators expect to perform long-term follow up to evaluate reoperations, conversions to     total hip arthroplasty and development of osteoarthritis for the patients surgically treated     for FAI.   "
74814|NCT02306512|"     The purpose of this study is to determine if immunofluorescence (IF) can effectively identify     features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs     Micrographic Surgery.   "
74816|NCT02306486|"     The aim of this double-blind randomized controlled clinical trial was to evaluate the effect     on dentin sensitivity using oxalic acid desensitizing agent before restoring with     resin-based-composites, during one-year follow-up. One hundred and twenty two cervical     lesions (31 patients, age range between 24 and 66 years) were selected and randomly divided     into four groups: OA/Z250: treated with acid oxalic desensitizing agent (Desenssiv, SSWhite)     before restoring with a methacrylate resin-based-composite (Z250, 3M ESPE), (n=31), OA/P90     treated with acid oxalic desensitizing agent (Desenssiv, SSWhite) before restoring with a     silorane resin-based-composite (Silorane p90, 3M ESPE) (n=31), Z250 restored with     methacrylate resin-based-composite (Z250, 3M ESPE) (n=30) and P90 restored with a silorane     resin-based-composite (Silorane p90, 3M ESPE) (n=30). All lesions were evaluated at baseline,     immediately and 1, 2, 3, 6 months and 1 year after treatment. Teeth sensitivity was measured     by visual analog scale (VAS) after evaporation and tactile stimuli   "
74817|NCT02306473|"     This is a clinical trial designed to test the hypothesis that measuring the absorption and     excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial     permeability in asthma.   "
74818|NCT02306460|"     Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There     for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left     atrial appendix closure can be used, if the risk for bleeding complications is deemed greater     than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic     complications can be prevented with anticoagulation therapy, and left atrial appendix closure     seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining     popularity as a therapeutic intervention for atrial fibrillation.      However, the procedure is associated with 0,5-1% perioperative risk of clinically evident     transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic     complications remain relatively low, recent data suggest that 13%-20% of patients undergoing     LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation.      The goal of the study is to improve detection of subtle brain dysfunction after cardiac     interventions by employing an experimental executive reaction time (RT) test along with EEG     recording in aims to improve objective detection of subtle brain dysfunction assumed to     underlie persistent cognitive, somatic, and affective complaints reported by patients who     have undergone atrial fibrillation ablation.   "
74819|NCT02306447|"     Magnetic stimulation of the brain (repetitive transcranial magnetic stimulation) and of neck     muscles (repetitive peripheral muscle stimulation) is used to alter tinnitus-related cortical     activity and neck muscles tension.   "
74820|NCT02306434|"     Childbirth related fear is a public health issue strongly related to subsequent reproduction,     a request for caesarean section and women's and children's health. Currently, women are     offered 3-5 counseling sessions with specially trained midwives and obstetricians in most     Swedish hospitals as standard care (SC). In general, women are satisfied with counseling but     research show no major effect on cesarean section rates neither in decreased level of     childbirth related fear. It is therefore important to find the best available treatment for     this issue.      The aim of this program is to compare Internet given cognitive behavior therapy (ICBT) with     standard counseling care for pregnant women reporting childbirth related fear.      Research questions: What effect does ICBT compared to SC have on a) the level of childbirth     related fear b) a request for cesarean section c) compliance and satisfaction with treatment.      Design: A randomized controlled trial of women reporting childbirth related fear during     pregnancy. One arm will receive SC and one arm ICBT though the U-CARE platform. Follow up of     given treatment will occur at 30 and 36 weeks of pregnancy, two months and one year after     birth. Intervention: The intervention will focus on management of childbirth related fear.     This means that the participants do weekly sessions and homework assignments during     pregnancy.      Primary outcome will be level of childbirth related fear measured at 36 weeks of pregnancy.      Secondary outcomes are level of childbirth related fear at 2 months and one year after birth,     preferences for mode of birth, request for elective cesarean section, compliance and     satisfaction with treatment and costs.      Expected benefits: This study will contribute to the development of new treatment methods for     childbirth related fear. Evidence of the best treatment to reduce childbirth related fear     based on the results from this study could be implemented in clinical practice and hopefully     decreases the numbers of cesarean sections without medical indications.   "
74821|NCT02306421|"     Simplified Milligan-Morgan is a surgical option which was improved and developed by Professor     He,well-known traditional Chinese doctor from Hunan province,based on Milligan-Morgan.RPH is     a new therapy for hemorrhoid following the improvement of rubber band ligation.RPH     +Simplified Milligan-Morgan is one of important means of modern surgery.The operation method     was improved and developed on the basis of Chinese medicine traditional loop ligature and it     also embodies uniqueness and advantage of the treatment of mixed hemorrhoids combined     traditional Chinese and Western Medicine.The study intends to compare five surgery ways     through 3000 cases of patients with mixed hemorrhoid from 12 hospitals,observing the efficacy     and safety of various operative methods.Exploration of RPH + Simplified Milligan-Morgan     operation indication, contraindication, operation steps and key points, and the operation     complications and sequelae and treatment etc provide evidence of evidence-based medicine for     Clinical application.   "
74822|NCT02306395|"     The purpose of this study is to determine whether edometrial local injury improves the     outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of     intervention,and the possible mechanism.   "
74823|NCT02306382|"     Drainage of perianal abscesses is a well established treatment. Traditionally its been done     in general anesthesia after the swelling has been localised its been drained with a knife.     After surgical intervention complications can occur with recidivism, chronic fistulas that go     from the anal to the skin and sometimes the anal sphincter is damaged which can cause     problems with incontinence.      Through ultrasound the abscess is opened under more controlled forms with a better visual     overview. This is a new technique that has not been tested in larger studies. The aim with     ultrasound-drainage as with traditional incision to drain the abscess so that the infected     area can heal.      The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D     ultrasonography.   "
74824|NCT02306369|"     This randomized controlled trial aims to evaluate the treatment effects of an     internet-delivered CBT-program for adolescents with irritable bowel syndrome.   "
74839|NCT02306174|"     The purpose of this protocol is to investigate the effectiveness of a manualized, 20-week     group cognitive rehabilitation (CR) and exposure therapy (ET) course for compulsive hoarding.     The overarching aim is to understand whether this course will decrease the core symptoms of     hoarding and associated features.   "
74871|NCT02305758|"     This study seeks to evaluate the efficacy and tolerability of veliparib in combination with     FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or     rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan.      This is a blinded study such that the Investigator and Subject will be blinded but AbbVie     will be unblinded.   "
74825|NCT02306356|"     An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the     rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered     Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting.     20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation     anxiety, specific phobia and their parents will be recruited from the CAMHS-center in     Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by     clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month     follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale     (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and     parent-rated anxiety and functioning.   "
74826|NCT02306343|"     The study is an open-label, randomized, two-period, one-way crossover study using the Meal     Tolerance Test (MTT) protocol or the daily life setting protocol.      The study consists of two parts. Subject may participate in both parts or just in one part.      The first part tests the effect of local heating on the post prandial glucose levels     following a bolus at in-patient settings.Type I and type II diabetic patients on basal bolus     insulin therapy admitted after overnight fast for a meal tolerance test. Subjects injected     0.2 units/kg and consumed standardized liquid meal. Blood samples for glucose and insulin     measurements was taken from a venous line. The study was conducted twice with (test) and     without (control) the use of the InsuPad device.      The second part evaluate the safety and efficacy of the device use at daily life settings.     Type I and type II diabetic patients enrolled to the study. They will be required to perform     at least 3 self monitored blood glucose (SMBG) measurements. Study length is up to 25 months.     Up to one month run in period, up to 12 months with the device (test) and up to 12 months     without the device (control).The subjects will be asked to record events of hypoglycemia,     hyperglycemia and any adverse events related to diabetes or the study.   "
74827|NCT02306330|"     MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood     cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an     important new technology that is becoming routine in developed countries. It is currently     unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing     countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi     Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.   "
74828|NCT02306317|"     The purpose of this study is to determine whether saturation control by parents in children     younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases     the time in which these patients remain at optimal saturation range. If the hypothesis of     this study is confirmed premature infants could prevent episodes of hypoxia-hyperoxia and     also give more relevance to the role of parents in caring for their children admitted in a     neonatal intensive care unit.   "
74829|NCT02306304|"     The study aims at screening Israeli Arab men, smokers or past smokers, for abdominal aortic     aneurysms (AAA).      The screening is to be performed at the family doctors clinics in the rural arab erea of the     north of Israel.      Goals:      The investigators aim at revealing the actual prevalence of AAA in the Israeli Arab smoking     men population. By revealing this prevalence we believe the need for a nation-wide screening     program for AAA will turn available for assessment.      In addition, the goal of improving the accessibility of health services for the Israeli Arab     population is a key issue in the design of the research.      2000 patients are to be enrolled in the study over a period of 2 years. Each of the patients     will be examined once for a duplex ultra-sound and will be classified into one of 4     sub-groups according to the maximal aortic diameter found.   "
74830|NCT02306291|"     This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid     leukemia in combination with standard agents used to treat this disease.   "
74831|NCT02306278|"     The study is to observe the effects of gabapentin premedication on postoperative     pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are     randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or     placebo orally the night before operation day and 2hours before surgery,respectively.The     investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be     observed in GG than GP.   "
74832|NCT02306265|"     The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both     digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from     asymptomatic women undergoing screening mammography. These data will be included in a     subsequent and prospectively planned pooled analysis described in a separate protocol     (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other     clinical performance measures.   "
74833|NCT02306252|"     The CARE Program is a randomized trial of a cancer rehabilitation program designed to help     older cancer patients who have shown to have a loss of function.   "
74834|NCT02306239|"     Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to     severe intesitnal complications such as intestinal ischemia. The investigators study was     designed to find the effect of terlipressin on intestinal function in septic shock patients.   "
74835|NCT02306226|"     Post-market registry aimed at further evaluating the safety and performance of the ACURATE     neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with     severe aortic stenosis treated with the commercialized device   "
74836|NCT02306213|"     Recent studies have shown an increased incidence of renal replacement therapy after the use     of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However,     studies showing detrimental effects of HES have been conducted in mostly non-surgical     subjects. There are very few studies analyzing the effects of HES on renal function after     cardiac surgery, a population already at risk of renal dysfunction.   "
74837|NCT02306200|"     The goal of this project is to establish a biobank of clinical information, DNA, plasma, and     aortic tissue samples from patients with cardiovascular disease as well as healthy controls.   "
74838|NCT02306187|"     In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment.     However, the bone turnover markers or the bone mineral density (BMD) are not improved in some     osteoporotic patients even though they have taken BPs and alfacalcidol more than several     years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead     of BPs and Alfacalcitol.   "
74842|NCT02306135|"     mTOR kinase is part of the mTORC1 complex that promotes cap-dependent protein translation,     and part of the mTORC2 complex that activates AKT. Everolimus (Afinitor) is an allosteric     inhibitor of mTOR that suppresses mTORC1 activity. Everolimus is FDA-approved for the     treatment of ER+/HER2- breast cancer (in combination with exemestane), renal cell carcinoma,     subependymal giant cell astrocytoma (SEGA), and neuroendocrine tumors of pancreatic origin     (PNET), and is currently being tested in ongoing clinical studies in other indications. While     everolimus-based therapies elicit anti-cancer effects, most cancers ultimately progress and     exhibit everolimus resistance. This study will evaluate genetic mechanisms of resistance to     everolimus.   "
74843|NCT02306122|"     This study is a pilot test of an intervention that delivers timely diagnostic information     about medication nonadherence to doctors, and then offers the services of clinical     pharmacists to treat these nonadherence problems. Participating doctors will be notified when     a patient is 10 days late refilling a medication for diabetes, hypertension, or     hypercholesterolemia. In one randomization arm the pharmacist will contact the patient as the     default option (with no action required by the doctor), and in the other the pharmacist will     contact the patient only if the doctor actively chooses that the pharmacist take action.     Patients of participating doctors will be randomized to 1) one of these two pharmacist     options, 2) an information only control arm in which the doctor gets adherence information     but does not have access to a pharmacist for that patient, and 3) a no information control     arm. The investigators' central hypothesis is that the pharmacist will be consulted more     often when intervention by the pharmacist is the default outcome and that the default     pharmacist intervention will be the most beneficial for adherence outcomes.   "
74844|NCT02306109|"     ErmoSLA is a multicentric, randomized, controlled trial to compare effects of an intensive     or standard motor rehabilitation treatment on motor disability in people with ALS   "
74845|NCT02306096|"     This study evaluates the genomic profiles of breast cancer in a prospective and     population-based manner. In the first phase, breast tumors are analyzed by whole     transcriptome RNA-sequencing. Gene expression profiles, mutational profiles, and transcript     isoform-level data will be analyzed in the context of patient information,     clinicopathological variables, and outcome, with the purpose to develop new molecular     diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses     will be performed in the future.   "
74846|NCT02306083|"     In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are     included. Those with the history of intraocular and corneal surgery, diabetic and heavy     smokers are excluded from the study. Before starting the treatment all patients undergo     complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response     Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment     and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three     times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3     and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.   "
74847|NCT02306070|"     HCV antiviral therapy has evolved rapidly in recent years and access to these medications has     improved. While SVR is associated with improved liver outcomes, the rate of liver fibrosis     regression with SVR is variable and predictors of regression are not well established. In     addition, achieving SVR in patients with cirrhosis does not necessarily prevent     decompensation or eliminate the risk of HCC. A better understanding of the role insulin     resistance and impaired glucose metabolism have on these outcomes in HCV patients who achieve     SVR are needed.      Identifying and targeting potentially modifiable risk factors such as IR may be of     significant importance in preventing progression of and promoting regression of liver     fibrosis, reducing mortality and improving outcomes for HCV-HIV co-infected and     HCV-mono-infected patients.      This proposed pilot study will be the first to evaluate the role of Metformin on liver     fibrosis in HCV-HIV co-infected and HCV mono-infected patients with IR receiving DAA HCV     treatment.      If Metformin is effective in reducing liver fibrosis in this patient population, this will     represent a well-tolerated, easy to administer, inexpensive therapy that will protect against     negative HCV outcomes. This study will also be an opportunity to evaluate the impact of     insulin resistance and hyperglycemia have on viral clearance HCV-infected patients treated     with interferon-free regimens. In addition, the study will further explore the relationship     between HCV, insulin resistance and AFP levels.   "
74848|NCT02306057|"     This project will evaluate fluid balance and edema formation in children with congenital     heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the     child end up with a univentricular heart with one-chamber circulation ( Fontan circulation).     This project will evaluate if these children has increased micro vascular leakage before     surgery due to their congenital heart defect. The project will also investigate if the edema     formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and     hypothermia is caused by capillary leakage of plasma protein.      The study hypothesis are        1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure          gradient through the capillary membrane.        2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB          and hypothermia.        3. Fontan circulation cause peripheral edema related to elevated central venous pressure          and is not caused by increased micro vascular leakage of plasma proteins.   "
74872|NCT02305745|"     Evaluating the long term cardiovascular risks of those mothers who have been diagnosed with     preeclampsia in pregnancy.   "
74850|NCT02306031|"     Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens     implantation surgery have enrolled. Fifty four eyes have received the conventional     postoperative care with steroid drop, whereas the other group (54 eyes) have given a     preoperative diclofenac drop four times daily in addition to steroid drop and continued six     weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT)     preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual     acuity (BCVA) and OCT findings were compared in and between both groups.   "
74851|NCT02306018|"     The investigators are trying to evaluate the agreement of cardiac output measurements taken     using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the     EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken     using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic     liver transplantation.   "
74852|NCT02306005|"     The aim of the study is to evaluate the effect of insulin therapy in patients with newly     diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins,     with particular emphasis on HDL metabolism, and analysis of the factors determining the     effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100     people with newly diagnosed type 1 diabetes and lead prospective observation of this group     (for a minimum of 5-10 years). Patients will be assessed: during the first hospitalization in     the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6     months and after 12 months of insulin therapy. Further observations planned in the annual     intervals. In addition, the study group will be under constant monitoring of metabolic     evaluation every three months in the Outpatient Clinic.      During each follow-up will be assessed parameters evaluating the metabolism of plasma     lipoprotein fractions and subfractions of HDL:        1. The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E        2. Electrophoresis of plasma lipoproteins        3. Electrophoresis of HDL        4. The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma          lipoprotein lipase Moreover, evaluation of factors which may potentially modify the          relation between insulin therapy and lipoproteins will be assessed             1. Anthropometric data and markers of insulin resistance (such as BMI, waist-hip               ratio, the estimated rate of glucose distribution, VAI index, body fat, blood               pressure),             2. Metabolic management of diabetes,,             3. Protein glycation end products             4. The concentration of plasma adipokines.      Expected impact of the research project on the development of science, civilization and     society The obtained results allow to assess the impact of exogenous insulin on quantitative     and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1     diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it     seem to be very important in the treatment of patients with type 1 diabetes, where insulin is     the treatment of choice and dosage adjustment appears to be extremely important. Remains     unknown whether the changes in the lipoprotein profile result from the beginning of insulin     therapy or other factors influence it. Selecting a group of patients with less favorable     lipoprotein profile may allow better metabolic control, and thus will affect the quality and     length of life of our patients. These studies will assess the impact of our therapeutic     actions on the diagnosis of the disease on long-term consequences, such as the development of     chronic complications.   "
74853|NCT02305992|"     Once kidney function goes below 10 to 15 percent of normal, dialysis treatments or a kidney     transplant are necessary to sustain life. One type of dialysis is hemodialysis which cleans     blood by removing it from the body and passing it through a dialyzer, or artificial kidney.     To maximize the amount of blood cleansed during hemodialysis treatments, there should be     continuous high volumes of blood flow. A fistula used for hemodialysis is a direct connection     of an artery to a vein. Once an arteriovenous fistula (AVF) is created it is a natural part     of the body. This is the preferred type of access because once the fistula properly matures     and gets bigger and stronger; it provides an access with good blood flow that can last for     decades. After the fistula is surgically created, it can take weeks to months before the     fistula matures and is ready to be used for hemodialysis. There have been surgical factors     identified; one of them being the anesthetic used which may cause a fistula not to survive.     This study will look at comparing 3 anesthetic techniques: axillary block (AB) versus     stellate ganglion (SGB) block+local anesthetic versus local anesthetic (LA).   "
74854|NCT02305979|"     The purpose of this project is to assess the efficacy of loratadine in decreasing the     incidence and severity of bone pain following G-CSF administration in patients with     hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells,     and patients who have undergone an autologous hematopoietic cell transplant. This is a     different patient population than those being assessed in current clinical trials.   "
74855|NCT02305966|"     Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced     arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal     hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the     upper arm. This orientation is opposite to the normal anatomy, giving rise to the term     reverse shoulder replacement. While RTSA has a good clinical track record, no studies have     examined how well fixed the implanted components are within patients.   "
74856|NCT02305953|"     Psoriasis is an inflammatory disease involving the skin, the joints and the vascular     compartment. The mechanisms linking inflammation in the skin and joints and in the vascular     walls are poorly understood. One hypothesis for the increase in vascular inflammation     observed in patients with psoriasis involves circulating pro-inflammatory cytokines. Patients     with psoriasis have an increase in serum levels of tumor necrosis factor alpha (TNF-alpha),     Interleukin-17 (IL-17), IL-22, IL-6 as well as a the chemokine S100A913. It is possible that     one of those cytokines/chemokine induces vascular inflammation in the vascular compartment.     The purpose of this cross sectional retrospective study is to highlight the correlation     between vascular wall inflammation using 18F-2-fluoro-2-deoxy-D-glucose - Positron Emission     Tomography (FDG-PET) fluorodeoxyglucose technology and pro-inflammatory cytokines/chemokine.   "
74857|NCT02305940|"     This study investigates if long term use of the antibiotic doxycycline can reduce     exacerbations in COPD patients. Half of the patients will receive doxycycline which the other     half will receive a placebo.   "
74858|NCT02305927|"     The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol)     supplementation on maternal HIV progression, small-for-gestational age infants, and infant     stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving     highly active antiretroviral therapy (HAART).   "
74859|NCT02305914|"     This is a follow-up study focusing on long-term complications of acute pancreatitis. The     primary purposes include: 1. To assess the incidence of type 2 diabetes     mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after     acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute     pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer,     pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the     long-term influence of acute lung injury(PaO2/FiO2<200,FiO2 means fraction of inspiration O2)     in AP patients during ICU stay on life qualities of the patients; 4. To observe the prognosis     of the local complications of acute pancreatitis(AP) patients; it might be helpful to find     the most effective and targeted interventions aiming at different phases after AP attack.   "
74873|NCT02305732|"     The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is     to address current gaps in platelet transfusion safety in selected geographic regions. The     objective is to provide access to INTERCEPT PCs for patients who might be at risk of     transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus     (DENV) in regions in which a substantial proportion of the population has been infected or is     at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic     infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).      The study is designed as a prospective, open label, multi-center, observational study to     evaluate the safety and efficacy of INTERCEPT platelet components.   "
75246|NCT02300870|"     The primary objective of this proposal is to show the efficacy of contrast enhanced     ultrasonography in detecting heart transplant rejection in humans. The secondary objective is     to demonstrate the efficacy of this technique in generating data which allow for the     assessment of short and long term outcomes.   "
74862|NCT02305875|"     The investigators have made a favourable experience with the in 2006 published transarterial     triple injection method [4]. This classic method combines the block effect of an axillary     catheter injection (median nerve position) with a double transarterial injection at terminal     nerve level in the axilla.      The investigators experience after a recent published MRI study [3], confirms that a proximal     axillary local anesthetic injection via an axillary catheter, guided by nerve stimulator, is     beneficial for the block effect. The MRI study was conducted using nerve stimulation and a     transarterial technique. The proximal injection with an effect at cord level, combined with     axillary injections at terminal nerve level, produce an effective block distal to the elbow.      The proximal injection has obviously an effect to the lateral cord and the musculocutaneous     nerve (mcn) [3]. Recent studies have advocated that a double axillary injection method is     sufficient for the axillary block [5, 6]. Their block techniques included a selective block     of the mcn at terminal nerve level. The investigators MRI study [3] demonstrated a successful     block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of 15 patients)     in the triple injection group without a selective block of this nerve. In the 1- deposit     (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15 patients (73%)     had the mcn successful blocked.      The objective in this study (Article 4) is to examine the mean position of the mcn nerve and     its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal     directed axillary catheter in median nerve position is beneficial in order to provide a     successful mcn blockade? Is a selective injection to the mcn at terminal nerve level     superfluous when a catheter is used?   "
74863|NCT02305862|"     The aim of this study is to assess whether high intensive statin therapy could regress     carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic     Resonance imaging (CE-MRI).      Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic     plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of     Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and     each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion.     Moreover, lipid level and major adverse cardiovascular events are also evaluated during     follow-up.   "
74864|NCT02305849|"     The objective of this study is to verify the efficacy of ASP015K versus placebo administrated     in combination with methotrexate (MTX) over placebo in terms of efficacy in patients with     rheumatoid arthritis (RA) who had an inadequate response to MTX   "
74865|NCT02305836|"     A prospective randomized controlled trial aimed at assessing if electroacupuncture (EA)     combined with donepezil is more effective than donepezil for improving the cognitive function     of AD patients. The hypothesis of this study is as follow:        -  Is the short-term effect of EA combined with donepezil better than donepezil on          improving cognitive function of patients with Alzheimer's disease after 12 weeks'          treatment?        -  Whether the effect of EA combined with donepezil on improving cognitive function can          last until the end of 6 months' follow-up?   "
74866|NCT02305823|"     The selection of antipsychotic in early stages of the illness is mainly determined by its     clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug     treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a     homogeneous group and clinical effects and profile of side effects differ between SGAs.     Differences among antipsychotics in terms of effectiveness have turned out to be a topic of     increasing research interest, although comparisons between the different SGAs are scarce. In     first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to     first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less     evident seems to be the notion that some of the SGAs might be more effective (in terms of     treatment discontinuation) than others. Most of the medium-term randomized studies have shown     similar rates of all-cause treatment discontinuation in first episode patients treated with     different SGAs. It may be concluded that more randomized controlled trails should be     accomplished to determine the position of frequently used SGAs in clinical practice. The     investigators undertook this study with the major objective of comparing the clinical     effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in the     acute treatment of first-episode non-affective psychosis individuals.   "
74867|NCT02305810|"     Everolimus represents an approved therapy for patients with advanced well/moderately     differentiated pancreatic NETs. Although some patients could benefit from this drug in terms     of long-term tumor growth control, others are resistant upfront or become resistant during     treatment. Therefore, it is crucial to detect some biological factors which can help to     identify the responsive tumors. Given that Everolimus is a biological agent and its mechanism     of action can be partially directed towards angiogenesis its effects can be studied on     different levels and with different methods. Upfront and early surrogate predictive markers     of activity/efficacy can be studied on tumor tissue, tumor imaging, and peripheral blood.     mTOR pathways alterations, circulating endothelial cells, and other circulating angoigenic     factors will be correlated with clinical outcome. Tumor perfusion and circulating markers     will be studied also as markers of response compared with the morphological imaging.   "
74868|NCT02305797|"     To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients     with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5)     and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will     be measured by a statistically significant greater mean reduction from baseline compared to     endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton     Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.   "
74869|NCT02305784|"     YKL-40 is proposed as a biomarker of various inflammatory disease diabetes and lung disease     including cystic fibrosis. In those cross-sectional studies, a unique value of YKL-40 is used     to correlate with clinical, physiological, or biological determinants of disease severity     (like FEV1 for example in lung disease). There is only one longitudinal study that showed a     correlation between circulating levels of YKL-40 and the decline of lung function in smokers     sampled from the general population. In order to better understand the potential role of     YKL-40 in CF pathophysiology, and to determine its potential role as a biomarker of disease     evolution, it is essential to proceed with further clinical evaluation. The investigators     propose to perform an observational prospective cohort study to determine if variation of     YKL-40 concentration over 24 months correlates with the clinical evolution of the patients.   "
74874|NCT02305719|"     Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic     surgery to evaluate their efficiency in (postoperative) pain control.      Three regional anesthesia forms are evaluated: thoracic epidural anesthesia,     (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic     at the site of performing the thoracoscopy.   "
74875|NCT02305706|"     Colonoscopy is technically challenging. Conventionally, colonoscopy begins with patients     positioned in the left lateral position. However, few published studies have explored     alternatives and there is consequently little evidence to support left lateral starting     position over alternatives.   "
74876|NCT02305693|"     140 women with clomiphene resistant PCOS will be randomly divided into 2 equal groups using     computer generated random numbers. Group 1 will receive Letrozole, group 2 will have     laparoscopic ovarian drilling (LOD).   "
74877|NCT02305680|"     This study is to describe the long-term antithrombotic management patterns in a real-life     setting for patients hospitalized with an acute coronary syndrome in China.   "
74878|NCT02305667|"     Introduction: Compared with the Macintosh laryngoscopy (MAC), the videolaryngoscopes (VL)     provide superior glottis views and longer times to double-lumen tube (DLT) intubation. We     hypothesize that the use of the King Vision™ (KVL) and the Airtraq® VLs may reduce the time     for DLT intubation compared with the Glidescope® (GVL) and MAC in patients undergoing     thoracic procedures.      Methods: One hundred-forty patients who will be scheduled for elective thoracic procedures     using the DLT for one-lung ventilation will be randomly assigned to one of four groups (n=35     per group) to intubate using the MAC, GVL, Airtraq®, or KVL. Time to DLT intubation, glottis     view, ease of intubation, number of optimization maneuvers, and failure to intubation (>150     s.) will be recorded.   "
74879|NCT02305654|"     This is an international phase III trial, with a Bayesian design, incorporating two     sequential randomisations. It efficiently examines a series of questions that routinely arise     in the sequencing of treatment. The study design has evolved from lengthy international     consultation that has enabled us to build consensus over which questions arise from current     knowledge and practice. It will enable potential randomisation for the majority of patients     with inguinal lymph node metastases and will provide data to inform future clinical     decisions.      InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological     criteria. Treatment options are then defined according to the disease burden strata.     Treatment is allocated by randomisation. Patients may be allocated to one of three initial     treatments:      A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND);     or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).      After ILND, patients are defined as being at low or high risk of recurrence based on     histological interpretation of the ILND specimen. Patients at high risk of relapse are     eligible for InPACT-pelvis, where they are randomised to either:      P. prophylactic PLND Q. no prophylactic PLND   "
74880|NCT02305641|"     This is a phase IV, prospective, multicenter, non-interventional study (regulatory     post-marketing surveillance) in approximately 3,000 patients who are to receive Kadcyla     (trastuzumab emtansine). Patients with HER2-positive, unresectable locally advanced or     metastatic breast cancer, who have received prior treatment with trastuzumab and a taxane,     and administered Kadcyla infusion at physician's discretion will be registered for this     surveillance in Korea. Patients will be asked to provide informed consent; data will be     collected by electronic Case Report Forms for approximately 6 years.   "
74881|NCT02305628|"     This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing     surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab,     subcutaneous administration) per approved local labeling. Patients will be under observation     according to standard of care in Korea.   "
74882|NCT02305615|"     This prospective, multi-center, observational study will investigate the effectiveness and     safety of Avastin (bevacizumab) in routine clinical practice in patients with metastatic     colorectal cancer. Patients are to have initiated first-line treatment with     fluoropyrimidine-based doublet chemotherapy plus Avastin according to the Avastin Summary of     Product Characteristics (SmPC). Target patient enrollment is 300 in Hungary.   "
74883|NCT02305602|"     This Phase I, open label, study will investigate the effects of VentriGel injection in     patients who have experienced a first, large ST elevation myocardial infarction (STEMI)     treated by PCI within the past 3 years and have evidence of left ventricular remodeling.   "
74884|NCT02305589|"     This study evaluated the effect of sugammadex on postoperative delirium in elderly patients     undergoing hip fracture surgery.      Medical records from 235 consecutive patients undergoing hip fracture surgery were     retrospectively reviewed and total 61 patients were excluded for age under 60 years,     preoperative neurologic problem. Finally total 174 patients aged over 60 years undergoing hip     fracture surgery with general anaesthesia using a neuromuscular blocking agent from 2012 to     2014 at a university hospital were analyzed to compare perioperative incidence of     postoperative delirium, pulmonary complications, intensive care unit (ICU) admission, and ICU     and hospital stay duration and laboratory findings between patients treated with sugammadex     (S group) and conventional cholinesterase inhibitors (C group).   "
74885|NCT02305576|"     The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate     Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic     tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However,     many perioperative factors such as medications, position, maneuvers may influence the ANI     values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid     dosing has never been tested. Therefore, the aim of our study is to collect in a database all     the perioperative factors and to study their influence on the ANI.   "
74887|NCT02305550|"     Study Design: This is a two-part physiological for a device feasibility. Both studies are     proof of concept descriptive pilot studies.      The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with     pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).      Volunteers and patients will be enrolled sequentially; there is no group randomization.      Overall hypothesis of this device feasibility study: To test a lightweight and portable     method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical     pulsed discharge.   "
74888|NCT02305537|"     The collection of patient self-report and diagnostic data will allow us to examine the     efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data     gathered through routine clinical care, the investigators seek to explore whether patients in     treatment show improvements from admission to discharge, compared to patients on the     waitlist, and whether these gains are maintained three months post-discharge. The following     are included as examples of some of the study's hypotheses.   "
74889|NCT02305524|"     The objective of this study is to compared effectiveness of intubation using ETView VivaSight     SL and standard tracheal tube during resuscitation performed by a EMS-paramedics.   "
74890|NCT02305511|"     The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO     intraosseous devices to standard peripheral venous catheterization during pediatric     resuscitation.   "
74891|NCT02305498|"     Previous research suggests that regular physical activity may make cancer survivors do better     in the long run. Laboratory studies suggest that stress may be bad for cancer patients as     well. The investigators are interested in whether yoga, a practice that combines physical     activity and stress reduction, is beneficial to cancer survivors. To answer that question,     the investigators will need to do a large scale clinical trial.      Before the investigators can do that large study, they need to know whether people are     willing to participate in this kind of study, whether they can do the yoga practice regularly     and for how long, what kind of changes they may experience in how they can handle their daily     activities, emotion, sleep, memory and problem solving ability, and what are the changes that     can happen in their body after doing the yoga practice. Answering these questions is what     this study is about.   "
74892|NCT02305485|"     The NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial is a prospective,     multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable     coronary scaffold with XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) to     evaluate the safety and efficacy of NeoVas in the treatment of patients with de novo coronary     lesion.   "
74893|NCT02305472|"     The NeoVas Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center,     single arm registry trial based on the NeoVas FIM study which verified the safety and     effectiveness of NeoVas initially. This study is to evaluate the safety and effectiveness of     NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de     novo coronary lesion.   "
74894|NCT02305459|"     The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of     selective internal radiation therapy (SIRT) for the treatment of patients with primary and     secondary liver tumours. The CIRT Registry has two major objectives: 1) To collect robust     data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres in     a pan-European context, and 2) to collect data on the Quality of Life of patients treated     with SIR-Spheres microspheres.   "
74895|NCT02305446|"     The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to     collect blood donation. Sera panel obtained from blood donations will be used as a control to     measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.   "
74896|NCT02305433|"     Our objective is to study the effects of 12 months' intensive home-based physiotherapy with     12 months' follow-up in two groups of older people: 1) those with an operated hip fracture     (60+ y), and 2) those with signs of frailty (65+ y). The primary outcome measure is duration     of living at home. Power calculations are based on the assumption that persons assigned to     physiotherapy will live at home for six months longer vs. those in usual care. Secondary     outcomes are physical functioning, falls, health-related quality-of-life, use and costs of     social and health services, and mortality.      We will recruit 300 persons with hip fracture and 300 with signs of frailty in Eksote (South     Karelia Social and Health Care District), Finland (population 133 000). The groups will be     randomized separately into an intervention arm (home-based physiotherapy twice a week for 12     months) and a control arm (usual care), resulting in 150 patients in each group.      An assessor-physiotherapist and assessor-nurse performs measurements at the participant's     home at baseline, and after 3, 6 and 12 months. Assessments include, among others, Fried's     frailty criteria, Short Physical Performance Battery (SPPB), Functional Independence Measure     (FIM), Health-related quality-of-life (HRQoL, 15-D), Mini Nutritional Assessment (MNA), Falls     Efficacy Scale - International (FES-I), Social Provision Scale (SPS), Mini Mental State     Examination (MMSE), and Geriatric Depression Scale-15 (GDS-15). At 24 months we collect     register information on mortality and the usage of health care services.      Recruitment will begin in December 2014 and last for three years. Data analyses and reporting     will take place in 2017-20. The study is supported by the Social Insurance Institution of     Finland.   "
74897|NCT02305420|"     EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage     Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to     this difficult group of patients.      Results showed a highly significant effect of 44% relative improvement in ongoing     implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).      We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media     improves pregnancy outcomes in women with recurrent implantation failure, recurrent     miscarriage and poor embryo development when compared to standard media.   "
74935|NCT02304926|"     Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with     statins and ezetimibe generally constituting the medication of choice. By acting at different     levels, the combination of these drugs allows the therapeutic objective to be achieved.     However, it is not known how these drugs qualitatively affect the composition of lipoprotein     subfractions, which differ in size and atherogenic potential. The investigators set out to     evaluate this effect as well as their effects on inflammatory, oxidative stress and     endothelial function parameters.   "
74939|NCT02304874|"     Normal body iron store value in overweight subjects is currently not described in literature.     The comparison of this value with body iron levels in patients suffering from dysmetabolic     iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The     purpose of the study is to determine iron levels in healthy overweight volunteers, and to     compare them to DIOS patients treated with phlebotomy.   "
75247|NCT02300857|"     This study will evaluate the effect of macronutrient diets on brain activity in homeostatic     and mesolimbic reward regions.   "
74898|NCT02305407|"     Adult patients with moyamoya disease (MMD) are reported to suffer from considerable     impairment of executive function/attention. Although reduced cerebrovascular reserve (CVR) in     frontal areas has been detected by perfusion MRI and then confirmed to be associated with     executive dysfunction in adult MMD, the structural and functional changes is still unclear     with progression of executive dysfunction. Furthermore, it is very important to study the     association between the neurocognitive and radiological improvement after surgical     revascularization, so as to help detecting cerebral regions which are involved in executive     deterioration or improvement after surgery. Then the investigators can determine whether     these regions can be used as indicators to decide rational therapeutic schedule and timing of     adult MMD with executive dysfunction.      Thus the aim of this study is to primarily find out the neuropsychological and radiological     correlates in adult MMD, and then to quantitatively evaluate the effectiveness of surgical     revascularization in prevention of executive dysfunction in adult MMD.   "
74899|NCT02305394|"     Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the     current antidepressant agents，but the most important side effect is cognitive dysfunction.     The purpose of this study is to determine whether subanesthetic dose of ketamine combined     with propofol is superior to propofol anesthesia alone in improving cognitive function in     depressive patients undergoing ECT.   "
74900|NCT02305381|"     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of     the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as     add-on to basal insulin alone or basal insulin in combination with metformin in subjects with     type 2 diabetes.   "
74901|NCT02305368|"     In patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases     (lung and liver metastases), treatment with chemotherapy is necessary but not end in success     in 10% of cases. The development of techniques for administering personalized treatment     becomes necessary for these patients. Thus, in vitro tests on cells from tumors of these     patients and evaluating the effect of chemotherapy on these could be made for each patient.     In France, the company develops Oncomedics these tests.      This is a pilot study that will make a first evaluation under actual conditions of     chimio-oncogramme.   "
74902|NCT02305355|"     Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in     subjects with type 2 Diabetes combined with hyperlipidemia   "
74903|NCT02305342|"     This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with     community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary     objective is to study the spectrum of uropathogens responsible for community acquired UTI in     local population   "
74904|NCT02305329|"     Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study     consisted of two consecutive single-dose treatment periods separated by a washout period of     10 to 14 days or more.   "
74905|NCT02305316|"     Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The     study consisted of two consecutive single-dose treatment periods separated by a washout     period of 14 days or more.   "
74906|NCT02305303|"     Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care     may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life.     Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess     if diaries may improve quality of life after a severe trauma.   "
74907|NCT02305290|"     The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER)     of superficial lesions of the Upper Gastrointestinal Tract(UGIT)   "
74908|NCT02305277|"     Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy     volunteers. In each part, the study consisted of two consecutive single-dose treatment     periods separated by a washout period of at least 14 days.   "
74909|NCT02305264|"     In this study we plan to image the compartmentalized inflammation in MS using molecular     imaging by positron emission tomography (PET) with a very highly resolutive camera. Two     tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral     benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This     new ligand for PBR displays several advantages compared to the existing reference compound     PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility with     [18F] ii) [18F]-fluoro-desoxy-glucose ([18F]FDG), which should reflect glucose metabolism in     activated immune cells in the white matter. Progressive MS patients (secondary progressive     and primary progressive) will be compared to relapsing-remitting patients and to healthy     volunteers. All subjects will pass a complete neurological evaluation and a multimodal MRI to     document clinical disability and tissue injury. A clinical and radiological follow up will     then be performed for a 2-year period. This study should help to understand the contribution     of the intracerebral inflammation on the progression of disability and could provide a     surrogate marker for further therapeutic trials in chronic progressive MS.   "
74910|NCT02305251|"     The investigators conducted a study Resect and Discard Diminutive Polyps: a new paradigm     (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors     performing colonoscopy are accurate enough at predicting histology of small colorectal     polyps, such that these small polyps could be resected and discarded (instead of being sent     to pathology). One of the main advantages of this approach is significant cost savings by     reducing pathology costs associated with screening and surveillance colonoscopy. A     disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no     data regarding patient preferences toward this approach. The investigators therefore designed     a patient survey to determine the patient's view toward this approach.   "
74911|NCT02305238|"     To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different     approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet)     Age-related Macular Degeneration (wAMD) .      To assess the safety of IVT administration of aflibercept with two different approaches of     Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.   "
74936|NCT02304913|"     This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to     sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of     dysgeusia in cancer patients undergoing chemotherapy.   "
74912|NCT02305225|"     The investigators examine changes in decision making, vigilance and cortical excitability in     healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand,     and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night)     on the other hand, in a cross over controlled manner. The investigators hypothesize that     total sleep deprivation, as well as partial sleep restriction lead to impairments in decision     making and vigilance, and enhanced cortical excitability.      Beside these three primary outcomes, the investigators also assess changes in sleep by EEG,     dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory,     and also collect saliva samples.   "
74913|NCT02305212|"     This study will examine a cognitive rehabilitation protocol targeted at working memory     deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized     clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to     improve working memory, will be examined in children with TBI. Neuropsychological and daily     life functioning will be measured. Participants will be children (N=20) and adults (N=20)     with a documented history of TBI. Participants will be randomized to a treatment group or a     wait list control group. The Experimental Group will receive the Cogmed working memory     training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time     of approximately 15 hours. The Control Group will be a wait list control group that will     cross over into treatment after the follow-up assessment. All subjects will undergo repeat     assessments following completion of the working memory training protocol after the 7th week     and again at 13 weeks to document changes in working memory performance.   "
74914|NCT02305199|"     The purpose of this study is to determine whether perioperative use of Hartmann's solution in     type II diabetes patients increases blood glucose level after surgery. The investigators     expect the result to broaden the choice of fluid for diabetic patients and hopefully to     diminish the side effects manifested by the excess use of normal saline.   "
74916|NCT02305173|"     Preoperative dexamethasone reduces symptoms after different surgical procedures including     mastectomy in breast cancer, but the effect in the postoperative respiratory function remains     unknown. The aim of this protocol was to determine if the administration of a single dose of     dexamethasone during the preoperative, could improve respiratory function and postoperative     symptoms of patients undergoing mastectomy in breast cancer.   "
74917|NCT02305160|"     The purpose of this study is to determine the efficacy and safety of the new pulmonary     surfactant produced by Butantan Institute among premature infants with gestational age below     34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.   "
74918|NCT02305147|"     Observational, prospective, monocentric study to assess clinical features, imaging and     biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to     healthy controls (HC) and subjects at risk to develop PD.      The primary objective of this study is to identify clinical, imaging and biologic markers of     PD onset and progression for use in clinical trials of disease-modifying therapies.   "
74919|NCT02305134|"     Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a     nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults     has already been established. It is reported that tipepidine inhibits G-protein-coupled     inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by     tipepidine is expected to modulate the level of monoamines in the brain. We put forward the     hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD)     symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK     channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether     treatment with tipepidine can improve symptoms in pediatric patients with ADHD.   "
74920|NCT02305121|"     The aim of this project is the prospective data collection of a new device used for     trochanteric fractures of the femur. It should be answered how the newly developed implant     called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing     clinically and radiological in terms of intra- and postoperative complications.   "
74921|NCT02305108|"     The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients     that are waiting for total hip arthroplasty. The fascial manipulation provides a deep     pressure of specific points of the muscle fascia. The aims of this treatment are the improve     of pain before the surgery and the improve of functional performance after the surgery.   "
74922|NCT02305095|"     The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine     (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction     (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous     genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide     binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the     therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self     designated African American subjects with systolic heart failure. They will be followed for     up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and     change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The     hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3     TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced     therapeutic benefit from FDC I/H.   "
74937|NCT02304900|"     The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens     with a refractive implant. Two colors of implants are available: white implants, filtering     out ultraviolet and yellow implants, filtering and more blue light. No clinical data are     available to assert the superiority of an implant according to its color and the choice is     made according to the preference of the surgeon and / or markets.      It is established in humans that blue light has an important role on the secretion of     melanopsin, a key mediator of the circadian cycle. This clock regulates most neuroendocrine     functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the     impact of these neuro endocrine functions of the installation of a blue light filter into the     eyes of patients operated thus arises.   "
74938|NCT02304887|"     The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we     plan to reveal relationship between osteoporosis drugs and kidney damage.   "
74924|NCT02305069|"     Obesity in humans has been shown to result in the increased release of small     inflammatory-inducing proteins, called cytokines, from the fat cells of the body. The     investigators are interested in the effects of these cytokines on the mechanisms that control     muscle mass and metabolism in the obese human. Previous research from work in cells and     animals has shown the cytokines reduce the synthesis of muscle proteins and simultaneously     enhance their rate of breakdown, resulting in a loss of muscle mass. Furthermore, research     suggests that the same cytokines may inhibit carbohydrate oxidation, a pivotal step in muscle     metabolism. However, despite these potential negative consequences for skeletal muscle     function, the effect of low-level and persistent inflammation as seen in obese humans,     remains largely unknown.      In the current study, the investigators plan to measure the rates of synthesis and breakdown     of muscle proteins in conjunction with rates of carbohydrate oxidation in obese older     participants, and compare them to rates determined in healthy non-obese individuals.     Furthermore, participants will undergo a 12-week course of either pioglitazone, an insulin     sensitiser often prescribed to type II diabetics, or a placebo. Pioglitazone has been shown     previously to normalise the levels of cytokines in the blood of chronically inflamed     individuals. By repeating after the 12-week intervention period the initial measurements     described above, and by accurately determining the levels of the cytokines, the     identification of the negative effects of obesity-induced inflammation in older adults on     muscle metabolism will be determined.   "
74925|NCT02305056|"     The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive     isotopic tagging (carbon 13 and nitrogen 15).   "
74926|NCT02305043|"     The aim of this study is to identify biomarkers predicting response or resistance factors of     a targeted therapy with trastuzumab in advanced gastric cancer.   "
74927|NCT02305030|"     Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a     washout period of at least 14 days.   "
74928|NCT02305017|"     Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods     separated by a washout period of 14 days or more.   "
74929|NCT02305004|"     To follow up the result of a quality measurement based on the results of a new routine for     drug analysis introduced during a period of time in the intensive care unit. To ensure the     quality of the dose regimen of routine drugs for sedation and analgesics. The aim is also to     find out if the routine analysis can give information about if the self- intoxicated patients     have taken drugs that were primarily not suspected.To know the serum concentrations of     routine drugs in patients who died and will undergo autopsy.   "
74930|NCT02304991|"     Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in     subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this     objective will be a statistically significant difference in challenge scores between the     treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food     challenge) performed after 36 months of peanut SLIT (desensitization). A secondary outcome of     this objective will be a statistically significant difference in the challenge score of the     treatment group versus the placebo group during the DBPCFC performed 3 months after     discontinuing therapy (tolerance). Challenge scores are measured by the amount of peanut     protein participants are able to ingest successfully without symptoms of an allergic     reaction. [Time Frame: Baseline, 39 months]      Secondary Objective: To examine the change in immune parameters associated with peanut SLIT     and the development of clinical tolerance. Through this objective, the investigators will     seek to understand the molecular processes by which SLIT affects the immune system through     evaluation of immune mechanisms in relationship to clinical findings of desensitization and     tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent     cellular and humoral responses to peanut protein: 1) peanut specific IgE, IgG, and IgG4     response, 2) peanut specific basophil activation, 3) mast cell responses through skin prick     testing, and 4) specific T-cell cytokine responses and T regulatory cell (TReg) activation.     The investigators anticipate that the effect of peanut SLIT will occur by induction of TRegs,     conversion of T cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte response     (measured by cytokines, antibody levels, and skin prick test size), a change in     peanut-specific basophil activation, or through a combination of the above.      [Time Frame: Baseline, 39 months]   "
74931|NCT02304978|"     Severity of colorectal cancer (CRC) is evaluated by its local staging, locoregional and     general ( presence of metastases , usually liver ). This is the most common cancer in France     and, despite surgical treatment of the primary tumor, it is still subject to a high mortality     rate due to metastatic evolution, mainly hepatic .      There is currently no specific marker for predicting cancer, the same hardly changed , which     would modulate the aggressive therapeutic strategy . antigen (CEA) is used in the monitoring     of JRC made.Tissue factor (TF) is the VII tissue factor receptor. it initiates the     coagulation cascade. it was noted as a true cell marker tumorale1 aggressiveness.     Corroborating evidence that the way the TF plays an important role in the invasive and     metastatic potential of CRC. First, various human cancer cell lines express the FT colic.     Furthermore, there is a relationship between the importance of monocyte TF expression and the     evolutionary potential of human CRC.      The investigators hypothesize that these interest intra-platelet and plasma markers are a     reflection of tumor angiogenic potential. And the investigators will verify the superiority     of their preoperative levels in the CRC group compared with the control group, normalization     of postoperative after surgical resection rates and their possible re-ascent in case of tumor     recurrence in the CRC group.      The levy to one month in controls allow us to verify the absence of secondary modification to     laparotomy, the colectomy and general anesthesia.      The investigators assume that the rate of soluble TF in peripheral blood of the holders of     CRC patients may be a marker of invasion and aggression (i.e. prognosis).   "
74932|NCT02304965|"     Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof     the feasibility of a specific individual training at home aimed to increase pulse pressure     above a predefined threshold which might attenuate the loss of arterial wall thickness.      Hypothesis:      Increasing daily physical activity near to normal (> 10.000 steps per day) with a pre-defined     level of pulse pressure (intensity) is a realizable and feasible approach to investigate     changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD patients.   "
74933|NCT02304952|"     The aim is to study the effects related to function and pain during eccentric exercise and     surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only     eccentric exercise, in patients with lateral epicondylalgia unilaterally.   "
74934|NCT02304939|"     CHIC study's purpose is to compare the efficiency, in terms of blood pressure stability, of     three changeovers of norepinephrine used routinely in ICU. The three techniques are:        -  Quick change        -  Double pumping        -  Smart infusion pumps   "
75567|NCT02296684|"     The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve     locoregional recurrence and distant metastatic rates in high-risk patients with locally     advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current     standard of care surgical approaches.   "
74940|NCT02304861|"     Objective of this study is the comparative assessment of the beneficial impact of the Viscoat     viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following     torsional-ip cataract extraction surgery.      Participants will be recruited from the Cataract Service of the University Hospital of     Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include     diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities     Classification System III (LOCS-3) grading scale. By means of a custom computer randomization     program all participants will randomly populate two study groups according to the OVD used     (ie. viscoat or visthesia).   "
74941|NCT02304848|"     The purpose of this study is to evaluate the effects of low frequency deep brain stimulation     on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the     cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech.     This study will provide insight into what the effects of low frequency stimulation are on     neural synchrony.   "
74942|NCT02304835|"     This study was a national, longitudinal, prospective, observational survey, carried out in     metropolitan France, with a sampling of 21 birth control centres.      The aim of this study was to assess, in real life conditions, the benefit of a urinary     semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the     concordance between qualitative results from the urinary test and quantitative values from     the beta-hCG blood measurement.   "
74943|NCT02304822|"     The purpose of this study is to compare the postoperative systemic inflammatory response     syndrome (SIRS) rates undergoing retrograde intrarenal surgery (RIRS) after multiple-,     single-, zero-dose of ceftriaxone prophylaxis in a prospective randomized trail.      The investigators will enroll 450 patients who are candidates for RIRS in the investigators     study. By simple random sampling technique, patients will be assigned to three groups     (multiple-, single-, zero-dose of ceftriaxone prophylaxis,respectively). In addition to the     difference of usage of ciprofloxacin prophylaxis, the rest of the procedure is the same in     all three groups.The end point of the study is the comparison of outcome of procedure     including SIRS rate, stone free rate (SFR), operation time, length of stay,and hematuresis.   "
74944|NCT02304809|"     Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic     alterations, the biological target of vemurafenib, and who are no more amenable to curative     treatment.      To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided     by the presence of identified activating molecular alterations in the vemurafenib target     gene, per cohort.   "
74945|NCT02304796|"     The current pilot study will examine and compare the effectiveness of two group     psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol,     adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.      In addition, change in proposed mechanism in each therapy will be examined, along with their     association with change in outcome measures during therapy.   "
74946|NCT02304783|"     Outpatients treatment with NSAI in renal colics has not been well investigated and there is     no clear recommendations regarding this matter.      The aim of this study is to determine if an oral NSAI treatment is beneficial in patients     discharged for the emergency departement after the first line treatment of a renal colic     investigating the recurrence of pain, the reconsultation rates and the admissions.   "
74947|NCT02304770|"     The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of     cervical precancerous lesions in women.   "
74948|NCT02304757|"     Postmenopausal women with differentiated thyroid cancer (DTC) taking suppressive doses of     levothyroxine (L-T4) are thought to have accelerated bone loss and increased risk of     osteoporosis. Therefore, the investigators try to investigate the effects of 99Tc-MDP,     calcium containing vitamin D alone and fosamax (alendronate sodium) in postmenopausal women     with DTC and decreased bone mineral density (BMD).   "
74949|NCT02304744|"     UCORBIO enrolls patients who undergo coronary angiography (for any indication). The     investigators draw blood at the moment of insertion of the procedural arterial catheter.      At the moment of inclusion indication, procedural details, risk factor status, medication use     and quality of life (RAND-36 and EuroQoL) is assessed. Patients are then followed-up for the     occurrence of major adverse cardiovascular events for 5 years. During the follow-up period     patients receive a questionnaire every year to check for hospital admissions. The     questionnaires at two and five years of follow-up are enriched with quality of life     questionnaires (RAND-36 and EuroQoL).   "
74950|NCT02304731|"     Modern society increasingly seeks healthy life style, and regular physical activity is     considered one of the main factors that improve the quality of life. The evidence shows that     the aerobic physical training in controlled environments benefit various aspects of human     health, including cognition in the elderly population. However, when exercise is performed in     a polluted environment, the individual is subjected to grater exposure to pollutants due to     increased ventilation (breathing).   "
74951|NCT02304718|"     This study evaluates the role of exercise intervention in reducing the risk of gestational     diabetes mellitus(GDM) risk of overweight/obese(prepregnancy BMI≥24kg/m^2） Chinese pregnant     women. Half of participants will have exercise intervention, while the other half will not.     Both of the two group will have regular prenatal care.   "
74952|NCT02304705|"     The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is     effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a     double-blind, placebo controlled trial.   "
74954|NCT02304679|"     The primary objective of this study is to evaluate the change from baseline in the erectile     function domain of the International Index of Erectile Function (IIEF-EF) scores in patients     receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment.     The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.   "
74955|NCT02304666|"     Inflammatory Bowel diseases (IBD) include Crohn's disease and ulcerative colitis. IBD's     precise origin is unknown until now. Today, the current hypothesis of the disease     pathogenesis is that IBD result from a dysregulated mucosal immune response to the gut     microbial flora in genetically susceptible hosts. The intestinal homeostasis depends on     interactions between immune and epithelial cells. Epithelial cells are the first line of     defense, are tightly connected to the underlying gut associated lymphoid tissue and their     alteration results in loss of tissue homeostasis.      Vanin-1 (Vnn1 in mice, VNN1 in humans) is an epithelial pantheinase which regulates the cell     response to stress.      This ectoenzyme hydrolyses the vitamin B5-derivative pantetheine to provide cysteamine to     tissues and regenerate pantothenate. Previous studies have shown that Vnn1 KO mice were more     resistant to experimental colitis and administration of cystamine (oxidized form of     cysteamine) restored their susceptibility to colitis. Furthermore, analysis of VNN1     expression in IBD patients show that high VNN1 expression is associated with severe clinical     features. Thus, analysis of VNN1 expression could represent a good prognostic marker.      In a recent published article, we characterized among a retrospective cohort of 500 IBD     patients and controls new SNPs (single nucleotide polymorphisms) in the VNN1 promoter and     showed their association with IBD incidence and high VNN1 expression. This suggested that the     VNN1gene might be a new predisposition marker of IBD.      In mouse, Vnn1 expression is tightly regulated by activation of PPARa and PPARg transcription     factors. Interestingly, one of the SNPs identified in patients participates to a PPARg     binding site. Interestingly, drugs related to the family of 5-ASA which are commonly used in     IBD, have PPARgamma agonist potential. Therefore, quantifying VNN1 levels in patients under     5-ASA therapy might help predicting response to therapy and select patients with the highest     benefit for this therapy.      The purpose of this new project is to extend our initial analysis. The study will be     prospective, monocentric and controlled. Its primary objective is to evaluate the level of     VNN1 expression in the colonic mucosa between IBD patients and control subjects to confirm     the correlation between high VNN1 expression and IBD. In relation with its prospective     nature, we will also try to associate VNN1 expression level with specific endophenotypes     (severity and/or localization of the lesions, quality of the response to therapy). Finally,     we will screen patients for the previously identified SNPs to integrate this information in     the interpretation of the results of expression analysis.      This study is planned on 2 years. Two groups of patients will be constituted: one group will     include IBD patients followed in the  Service de Gastro-entérologie du Pr Grimaud à     l'Hôpital Nord  and the other group will constitute the control cohort including persons who     were proposed a screening colonoscopy for familial history of colon cancer or polyps, or for     Irritable Bowel Syndrome.      The investigator will have to fill a questionnaire for each included patient, collecting     information about age, sex, past medical history, taken medicine, digestive symptoms and     colonoscopy indication.      IBD patients will have a first set of biopsies (n = 10) and blood samples collected under     general anesthesia during a colonoscopy planned in their IBD usual follow-up; a second set of     similar samples will be collected within the next 12 months if an endoscopic control is     medically justified. The control subjects will have only one set of biopsy and blood samples     collected under general anesthesia during their colonoscopy. In the particular case of IBD     patients who require surgery, a small piece of the resection will be collected ex-vivo on     both healthy and pathologic areas.      The blood sample will serve for quantification of the VNN1 seric pantheteinase activity and     SNP's genetic study.      The colonic biopsies will be obtained in duplicates from 5 different ileocolonic areas, one     for histopathological analysis and the other for transcriptional analysis by qRT-PCR.      The surgical samples will be used for transcriptional activity, tissue pantheteinase activity     and constitution of TMA (Tissue MicroArrays) bank for immunohistochemistry.      Expected benefits are to validate a new IBD prognostic marker for disease severity or     potentially for evaluation of the therapeutic response.   "
74956|NCT02304653|"     Aim: To investigate if the results of CRP and leucocytes had any positive or negative     influence on the surgeon's decision-making when handling patients with suspected AA.   "
74988|NCT02304237|"     This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of     progesterone therapy in prevention of preterm birth in high risk pregnant women.   "
74957|NCT02304640|"     There is a paucity of studies that focus on the symptom burden of cancer patients in     Singapore, particularly the clinical effects of cancer-related fatigue (CRF). Knowing that     early-stage breast cancer is curable, it is of paramount importance to evaluate the clinical     and biological determinants of lingering symptoms in breast cancer survivors so that     appropriate psychosocial interventions can be formulated.   "
74958|NCT02304627|"     This trial is conducted in Europe. The aim of the trial is to investigate the effect of food     on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in     a tablet formulation in healthy subjects.   "
74959|NCT02304614|"     3D surface imaging has been used in the objective evaluation of cosmetic outcome of     oncoplastic procedures such as breast reconstruction and lipofilling, however there is only     one article published relating to Breast Conserving Therapy (BCT).      The aim of this study is to assess the use 3D surface imaging as a tool in the assessment of     symmetry of outcome following breast conserving therapy. The results of the surface imaging     will be correlated with patient satisfaction, using the BREAST-Q, which is a validated     patient questionnaire and correlated with panel assessment by an independent panel of two     surgeons, one clinical oncologist and one breast care nurse.   "
74960|NCT02304601|"     The primary objective of this research is the development and testing of a brief     cross-indication instrument (screening) for use in the approval process of medical     rehabilitation services. In addition to the empirical foundation, this generic instrument     should have a high level of acceptance of both applicants and payers of rehabilitation     services. Furthermore, an everyday and economic use for the routine application process for     medical rehabilitation services at the German statutory pension insurance scheme should be     provided. In the first study phase, a long instrument was tested with a sample of     rehabilitees that received approval of medical rehabilitation services. This assessment     including the measurement of rehabilitation-related somatic, psychological and social     impairments was first tested for its psychometric properties and then reduced to a short     instrument (screening) using quantitative methods. In the second study phase, the     then-existing screening will be part of the application documents for medical rehabilitation     services to assess its management properties and practicability in everyday use of the German     statutory pension insurance scheme.   "
74961|NCT02304588|"     Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell     transplantation into ischemic foot, make its differentiation to form new blood capillary,     improve and restore the local blood flow.   "
74962|NCT02304575|"     Testicular Cancer is the most prevalent malignancy among men between 20 and 34 years of age,     with incidence rates rising in western countries including Israel. Cure rate of testicular     cancer exceeds 90% with modern treatments. Thus issues such as quality of life (QoL), coping,     effects on couple relationships, cognitive function, cognitive orientation and hormonal     function become increasingly important. This study aims to assess all these issues using     validated, reproducible questionnaires and hormonal plasma levels, and compare them between     testicular cancer survivors and controls.   "
74963|NCT02304562|"     Patients with skin injury treated with Umbilical Cord Blood-derived Mesenchymal Stem     Cells,such as deep burn damaged sweat glands,Effectiveness of Umbilical Cord Blood-derived     Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair is determined.   "
74964|NCT02304549|"     Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older     than 60 years.In cases with moderate to severe lower urinary tract symptoms (LUTS) monopolar     transurethral resection of the prostate (TUR-P) is the standard treatment. Especially in     frail patients, conventional TUR-P is associated with relevant and potentially deleterious     complications, e.g. TUR syndrome. Using isotonic saline, like in bipolar TUR-P and     transurethral laser vaporization (TUV-P), TUR syndrome can be prevented.      The short-term complication rate with the Thulium laser is similar to the rate described     after vaporisation with other laser systems18-23 and less than that with TUR-P.      Despite recent publications on the safety and complications with Thulium vaporisation of the     prostate, to the investigators knowledge, until now, no prospective trial has directly     assessed, whether absorption of irrigation fluid occurs and to what extent in Thulium Laser     vaporisation of the prostate.      The investigators therefore aim to investigate if absorption of irrigation fluid occurs     during Thulium Laser vaporisation of the prostate by expired breath ethanol test.   "
74965|NCT02304536|"     210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using     computer generated random numbers. Group 1 will receive combined metformin and FSH, group 2     will have LOD and group 3 will act as the control group with no intervention.   "
74966|NCT02304523|"     The purpose of this study is to evaluate the safety and efficacy of CDFR0612 and CDFR0613     compared to PEG+picosulfate (Coolprep Powder) preparation. The effectiveness for bowel     cleansing will be assessed with Harefield Cleansing Scale (HCS) by blinded assessor.   "
74967|NCT02304510|"     The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in     females aged between 18 and 50 years old living in Bejing.   "
74968|NCT02304497|"     Diabetic patients may show different release of growth factors when microvascular     complications such as; retinopathy or periodontitis are seen. Diabetes have an adverse effect     on periodontal health and periodontal infection have an adverse effect on glycemic control     and incidence of diabetes complications. Therefore, the investigators hypothesize that growth     factors levels releasing from platelet rich fibrin (PRF) in diabetes mellitus (DM) may be     decrease because of periodontitis is considered to be the sixth microvascular complication of     diabetes or diabetes may have inductive effect on PRF growth factors levels in periodontal     disease. Determination of PRF growth factors levels may be beneficial to treatment of     diabetic patient with periodontal disease by using PRF.   "
74969|NCT02304484|"     To characterize the safety and tolerability of long-term administration of evolocumab in     subjects with known coronary artery disease and hypercholesterolemia   "
74989|NCT02304224|"     The aim of the study is to investigate the relationship of nocturnal use of eye masks and     immune function, cerebral function and outcomes of patients with sepsis. Thus more efficient     and comprehensive treatment could be provided for patients in the duration of admission in     intensive care unit.   "
74970|NCT02304471|"     Cardiovascular disease is the major cause of morbidity and death in patients with chronic     kidney disease (CKD) and end-stage renal disease (ESRD). The mechanisms linking impaired     renal function and increased risk for cardiovascular diseases, however, remain elusive.      Long non-coding RNAs (lncRNAs) is a heterogeneous group of non-coding transcripts longer than     200 nucleotides. While the roles of lncRNAs in human diseases including cancer and     neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation     contributes to cardiovascular complications in patients with renal dysfunction.      In this proposal, the investigators seek to apply next-generation sequencing technology to     investigate circulating lncRNA expression in control subjects and in patients with CKD and     ESRD. The investigators will test the hypothesis that circulating lncRNA expression signature     can reflect the underlying kidney disease states in patients with CKD and ESRD. A gene     co-expression network analysis will be conducted to identify lncRNAs that are functionally     involved in the pathogenesis of CKD and ESRD. Next, the investigators will identify     circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD patients.     Finally, the investigators propose to test the hypothesis that circulating lncRNAs can be     novel prognostic biomarkers to predict cardiovascular outcomes and renal function progression     in CKD patients. The results from these experiments will lead to better understanding of how     circulating lncRNAs contribute to uremic cardiovascular complications and renal function     progression.   "
74971|NCT02304458|"     This phase I/II trial studies the side effects and best dose of nivolumab when given with or     without ipilimumab to see how well they work in treating younger patients with solid tumors     or sarcomas that have come back (recurrent) or do not respond to treatment (refractory).     Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different     ways by targeting certain cells. It is not yet known whether nivolumab works better alone or     with ipilimumab in treating patients with recurrent or refractory solid tumors or sarcomas.   "
74972|NCT02304445|"     This is a randomized, open-label, active comparator-controlled trial of subjects with     advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one     treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently,     subjects will be randomized to observation or, if indicated, up to an additional TACE     treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following     interventions will be evaluated at three months.   "
74973|NCT02304432|"     The purpose of this study is to assess the efficacy of d-cycloserine (DCS) as an augmentation     strategy in two psychotic patients with a triplication (4 copies) of the glycine     decarboxylase (GLDC) gene. Subjects will first undergo an eight-week open-label arm of     treatment with DCS (50 mg/d) followed by six 6-week double-blind placebo-controlled exposures     to DCS or placebo. The length of each double-blind arm is limited to six weeks to minimize     the length of symptom exacerbation experienced by the subjects when they are receiving     placebo. The randomization scheme will allow two consecutive exposures to DCS, but will not     allow two consecutive exposures to placebo, again to minimize the length of any symptom     exacerbation. At the end of the open-label DCS trial, the following procedures will be     carried out: structural MRI (3T), proton 1H MRS (4T), fMRI (3T), steady-state auditory evoked     potentials, and electroretinogram recordings. In addition, 1H MRS (4T) for 2 hours after a     single oral dose of a DCS will be assessed. Baseline data on all of these measures were     previously obtained as part of a different study registered in clinical trials.gov -     NCT01720316). Positive, negative, and affective symptoms and neurocognitive function as well     as plasma levels of large neutral and large and small neutral and excitatory amino acids and     psychotropic drug levels will be assessed periodically. Pharmaceutical grade DCS) or placebo     will be compounded and dispensed by the McLean Hospital Pharmacy.      The investigators hypothesize that mutation carriers will have reduced endogenous brain     glycine and GABA levels and increased brain glutamate and glutamine levels. DCS     administration will increase brain glycine in the two carriers compared to baseline and     treatment with glycine (0.8g/kg).      The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs     modulated by NMDA in mutation carriers compared with non-carrier family members and controls.      . The investigators hypothesize that DCS, but not placebo, will improve positive, negative     and affective symptoms as well as neurocognitive function.      The investigators also hypothesize that DCS will improve clinical and cognitive functioning,     will partially normalize decreased baseline glycine and GABA and increased glutamate and     glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked     potentials.   "
74974|NCT02304419|"     The main purpose of this study is to learn more about how the study drug called galunisertib     affects the immune system in participants with cancer. The study treatment is expected to     last about six months for each participant, not including screening or follow-up.   "
74975|NCT02304406|"     Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North     Africa population by using the Ventana ALK-IHC method for ALK protein detection in     retrospective NSCLC clinical samples, & to evaluate the association of ALK rearrangement with     clinical and pathological parameters of NSCLC patients in MENA.   "
74976|NCT02304393|"     This is an open-label, multicenter study designed to assess the safety, pharmacokinetics,     pharmacodynamics and activity of RO7009789 administered in combination with atezolizumab     (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be     conducted in three Parts (I, II, and III), with part I divided into Parts IA and IB. All     participants will be followed up for survival until death or loss of follow-up after the last     visit or withdrawal of consent.   "
74977|NCT02304380|"     The proposed study uses a recent policy change in Ohio as a natural experiment to assess     outcomes and experiences of children who qualify for Medicaid under the Aged, Blind, Disabled     category and their caregivers in an ACO model of care compared to their previous outcomes and     experiences in a traditional fee-for-service model.   "
74978|NCT02304367|"     UX023T-CL201 is an, open-label, Phase 2 study. The study will be conducted in adults aged 18     years or older with TIO or ENS whose tumor/skin lesion is inoperable to assess the efficacy     and safety of KRN23 administered via subcutaneous injections monthly (every 4 weeks) for a     total of 144 weeks. Subjects will need to discontinue oral phosphate and vitamin D metabolite     therapy prior to randomization and throughout the duration of the study.   "
74979|NCT02304354|"     Rituximab, an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in     rheumatoid arthritis (RA) patients refractory to TNF alpha antagonists. According to previous     studies, 25 to 50% of patients have an insufficient or absence of response to rituximab at     week 24.      In a recent retrospective study, a CD4+ T-lymphocytes depletion was observed after a first     course of rituximab in RA patients. The absolute CD4+ number at week 12 was 37% (±33) of the     baseline value, leading to < 200 cells/µL in 5% of patients. Interestingly the absence of     CD4+ T-lymphocytes depletion was observed in clinical non-responders, suggesting the     involvement of T-lymphocytes in the mechanism of action of rituximab. So far no prospective     study have supported the usefulness of lymphocyte phenotyping, in particular T-lymphocytes,     to monitor rituximab-treated RA patients.   "
74980|NCT02304341|"     Children are admitted in intermediate units when the severity requires continuous monitoring.     In France, Resources allocated to intermediate units are determined from lists of diagnoses     and associated acts to additional budget. A score to assess the severity of illness may be     associated with acts to develop an activity indicator easy to use. The investigators have     chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning     Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not     been validated. The correlation between the severity of children and the associated diagnoses     and acts has not been studied. The main objective of this study is to validate these 2     scores. The secondary objective is to determine a simplified activity indicator.   "
74981|NCT02304328|"     All patients (≥18 years) with a spontaneous SAH proven by computed tomography (CT), magnetic     resonance imaging (MRI) or lumbar puncture will be considered for this trial. Upon     presentation to a neurosurgical centre the patients will be treated according to the local     protocol. Upon admission the patient is clinically evaluated for occurrence of clinical signs     of brain herniation syndromes (anisocoria, bilateral dilated pupils, posturing). Usually     first line treatment includes neurological resuscitation (placement external cerebrospinal     fluid drainage in case of hydrocephalus, treatment of seizure, and general intensive care     measures). Hereafter, the patient is clinically evaluated for a second time. The patients     will be graded according to the usual WFNS scale and the modified herniation WFNS scale.     The whole treatment of the patient will be according to local clinical protocols. Outcome     will be measured at six and twelve months by trained investigators who are unaware of     clinical data. The primary endpoint is the difference of specificities of the WFNS and hWFNS     with respect to poor outcome (mRS 4-6) at 6 months after initial haemorrhage. Given that     specificity and sensitivity are negatively correlated, difference in sensitivity will be the     second primary outcome.      The null hypothesis to be tested is that the ratio of the true negative rates (specificity)     of the hWFNS and WFNS scores is 1.35 i.e. the new score will detect 35% more patients as     truly negative (good outcome) as compared to the old score. In addition and because of the     negative correlation between specificity and sensitivity we will also test that the ratio of     the true positive rate (sensitivity) is not below 0.82 i.e. the new score will not more than     18% less patients as truly positive (poor outcome).   "
74982|NCT02304315|"     This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of     hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to     determine its optional dose.   "
74983|NCT02304302|"     The purpose of this research study is to learn if the medication Memantine Hydrochloride (the     study medication) can help adolescents and young adults with Down syndrome. Dr. Alberto Costa     and his research team want to see if a 16-week treatment with this medication can improve the     participant's ability to learn and remember things. In this study, memantine hydrochloride     will be used. Thus, the researchers want to learn whether the study drug can help improve     memory in young adults with Down syndrome. To test the effect of the study medicine, half of     the people in the study will receive the study medicine and half will receive a placebo (an     inactive substance). Memantine is an approved medication to treat memory and thinking     problems in persons with Alzheimer disease. However, little is known about the effect of this     medication in persons with Down syndrome and it has not been approved for use in persons with     Down syndrome.   "
74984|NCT02304289|"     The purpose of this study is to evaluate the Safety and Pharmacokinetics of Oral Artesunate     in patients with advanced hepatocellular carcinoma (HCC)   "
74985|NCT02304276|"     This study will evaluate the two main types of replacement tissue heart valve used in current     practice, comparing outcomes from surgical aortic valve replacement (AVR) with that of the     more recently introduced key-hole procedure called transcatheter aortic valve implantation     (TAVI). Participants will be recruited at various time points ranging from 1 month to 10     years following valve replacement with either AVR or TAVI. It is thought that progressive     calcium (chalk) formation is responsible for the failure of the majority of these valves. All     participants will therefore have a PET-CT scan with a special type of tracer called     18F-fluoride in order to measure active calcium formation in the valve. They will then have     annual clinical follow-up for 5 years and be invited back for a repeat CT scan at 2 years to     measure change in calcium burden. This study aims to investigate, firstly, the effects of     valve age and type on calcium formation as measured by PET-CT and, secondly, whether this     measure of calcium formation can help to predict how long different types of valve will last.     If successful, 18F-fluoride PET-CT could become a valuable tool for testing new treatments to     improve valve longevity and new valve designs.   "
74986|NCT02304263|"     Tenofovir continues to play a vital role in the treatment of the human immunodeficiency virus     (HIV) and as the age of the HIV-infected population increases in the United States and     worldwide, there is an urgent need to understand the extent to which older age influences the     way this antiretroviral medication works in the body. The investigators study aims to     characterize and compare the pharmacology of tenofovir in older versus younger HIV-infected     adults and to assess kidney function over the course of approximately one year. The     investigators will be analyzing tenofovir levels in different compartments of the blood and     in hair samples, and will be assessing the relationship between tenofovir concentrations and     changes in kidney function over time in the older and younger cohorts. Lastly, the     investigators will be evaluating the relationship between tenofovir concentrations and     functional status (including body composition, bone mineral density, and frailty) in study     participants.   "
74987|NCT02304250|"     Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3].     Perioperative single-dose dexamethasone therapy has been used for several purposes: to reduce     post-operative nausea and vomiting (PONV), pain and sore throat. There are also some reports     on beneficial effects of less cardiac arrhythmia, improved appetite and less edema from     glucocorticoids. Preoperative small dose of dexamethasone was reported to prevent reversal     laryngeal nerve injury and improve voice quality after thyroid surgery. While accepted wildly     in clinical anesthesia practice, the immune-press related potential risks of side effects     associated with dexamethasone, such as delayed wound healing, infection, as well as effects     on blood sugar, make the use of perioperative single dose of glucocorticoid controversial.     The effect of perioperative dexamethasone on wound healing varied with different types of     surgery. The present study will observe the effect of dexamethasone on the safety of thyroid     surgery.   "
74992|NCT02304185|"     The purpose of this study is to assess the safety and tolerability of 2 different dose levels     of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly     (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in     healthy human immunodeficiency virus (HIV)-uninfected participants.   "
74993|NCT02304172|"     The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat     device to that with the harmonic scalpel.   "
74994|NCT02304159|"     This is a randomized, open label, single center safety and efficacy study. At least 40     cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir     and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product).     Subjects will be randomized in a 1:1 to receive either:        -  Group A: 16 weeks of DCV/SOF/RBV        -  Group B: 24 weeks of DCV/SOF/RBV      Subjects will return to the study center at various time points throughout the 16 or 24 weeks     of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety     and efficacy. These visits will be according to standard of care.   "
74995|NCT02304146|"     The aim of this study is to investigate the long-term follow-up of the previously conducted     FOAM study.   "
74996|NCT02304133|"     This study explores the effect of a four-hour ultrasound course on physicians' point-of-care     ultrasound performance on patients representing acute abdominal surgical conditions.   "
74997|NCT02304120|"     This study evaluates the effects of additional sensorimotor training (proprioceptive postural     training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the     participants will receive instructed treadmill training as an active comparator against PPT.     All participants receive conventional physiotherapy as prescribed by their treating medical     doctors. It is expected that the PPT group will improve in postural control, proprioceptive,     as well as pain and function outcomes to a significantly greater extent than the active     control group.   "
74998|NCT02304107|"     210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using     computer generated random numbers. Group 1 will receive FSH, group 2 will have Letrozole and     group 3 will act as the control group with no intervention.   "
74999|NCT02304094|"     The aim of this study is to establish which of two treatment options is the preferred     intervention in the treatment of Morton's Neuroma.      A randomised controlled trial shall be performed. Steroid injection is the current gold     standard conservative treatment for this condition. Therefore, manipulation shall be compared     to a control group receiving a steroid injection in an equality randomised controlled trial.      Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford Foot     Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of life     questionnaire and algometric pressure threshold testing. An improvement in either groups' VAS     of 20mm above the other group shall be considered as the minimum worthwhile change as this     has been identified as the minimum clinically important difference in pain between treatment     groups in visual analogue pain scales.      There is limited research evidence to support the management of Morton's neuroma with steroid     injection although its efficacy has only been demonstrated in the short term.   "
75000|NCT02304081|"     The purpose of this study is to evaluate alpha- and beta-cell function during combination     treatment with saxagliptin in addition to dapagliflozin and metformin compared to placebo in     addition to dapagliflozin and metformin in subjects with T2DM on stable metformin background     therapy.   "
75012|NCT02303925|"     With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent     proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the     hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Its acute     complications (external and/or internal thromboses) are unpredictable.      Surgical treatment concerns approximately 10% of patients with diagnosed hemorrhoidal     pathologies. The elective ligature of the arteria haemorrhoidalis under trans-anal Doppler     scanning was developed in order to reduce the postoperative morbidity of hemorrhoidal     surgery. This technique consists in a ligation of the superior rectal artery under Doppler     control in order to decrease the blood flow within the hemorrhoids and therefore to reduce     them. It is effective in the treatment of internal hemorrhoidal pathology without prolapse     (grade II). The complications rate is low and estimated between 2 and 12% : rectorrhagia     (4.3%), thrombosed hemorrhoids (1,8%), fissure (0,8%), acute urine retention (0,7%).      With the major advances in interventional radiology such ligation could be performed by an     endovascular coil embolization. Until now no direct study exists on the subject but several     case reports show the feasibility of an embolization of the superior rectal arteries for     rectorrhagia of various etiologies such as the hemorrhoidal disease.      Endovascular access should increase the selectivity of the embolization compared to the     Doppler scanning technique. Indeed the arteriography makes it possible to scan all branches     of the superior rectal artery and therefore to occlude permanently the branches that feed the     hemorrhoidal plexuses. Moreover the endovascular embolization technique should avoid the main     complications of the trans-anal access technique.      The primary objective of this study is : the assessment of the efficacy of endovascular coil     embolization of the superior rectal arteries in the management of the symptoms of the     hemorrhoidal disease grade II and III. The secondary objective is : the assessment of     postoperative complications.   "
75001|NCT02304068|"     Currently the best treatment for wet macular degeneration involves regular injections of     Ranibizumab (Lucentis). In the initial clinical trials, the drug was injected into the eye     every month. Since then a number of studies have found similar benefits when the drug is     given with a fixed number of injections initially and then with further injections only when     needed. This approach has been adopted in the UK, following recommendation by the National     Institute for Clinical Excellence (NICE).      Although this approach reduces the expense and risk of un-necessary treatment, it does     require regular hospital assessment of disease activity to determine if a repeat injection is     required or can be deferred. The hospital assessment is time-consuming, inconvenient and the     large number of assessments can cause delays in hospital follow-up.      Using three different assessment criteria to monitor disease activity at home, the     investigators plan to see if home monitoring is as good as hospital assessment. The     investigators have already identified that many patients dislike the lengthy hospital     assessment visit and would welcome the opportunity to do some of the monitoring of disease     activity at home. The investigators have also shown that they understand and can complete     each of the home assessment tests. In this pilot project, the investigators aim to get an     idea of how reliable home monitoring can be in a small sample of just over 30 patients. The     data that the pilot project generates will be used to influence and to help plan a     subsequent, larger, national study to be submitted for funding to the National Institute for     Health Research.   "
75002|NCT02304055|"     200 women will be randomly divided into 2 equal groups using computer generated random     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).   "
75003|NCT02304042|"     250 women will be randomly divided into 2 equal groups using computer generated random     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml     saline and will be given by the slowly intravenously after delivery of the anterior shoulder.     The investigators will not include a control group for ethical reasons.   "
75004|NCT02304029|"     Epilepsy is a common disease affecting 0.5 to 1% of the general population. Epilepsies     refractory to drug treatment lead to increased morbidity, mortality and high costs for public     health (representing 75% of the costs associated with epilepsy is among the most costly     diseases in Neurology). The only curative therapy is surgical removal or disconnection of the     epileptogenic network. To do this, a comprehensive presurgical evaluation is essential to     accurately define the location of the epileptogenic zone (EZ) and its relationship with the     functional areas that must be preserved. This approach requires in some cases intracerebral     EEG recordings. This latter technique, expensive and invasive, remains at present, the     standard method in the location of the ZE. In this context, the development of non-invasive     and inexpensive methods is a priority in the field. Moreover, many fundamental studies have     shown changes in ion homeostasis including sodium associated with hyperexcitability related     to epilepsy. The investigators team at CEMEREM, CHU Timone, specialized in the development     and validation of innovative methods in MRI, has developed an in vivo sodium MRI acquisition     and processing of data unique in France, capable of quantifying the intracerebral sodium     concentration in three dimensions in a completely non-invasive and non-irradiating manner   "
75005|NCT02304016|"     The purpose of this study is to determine if patients with third and fourth degree obstetric     lacerations benefit from a short course of pelvic floor physical therapy in the immediate     postpartum period.   "
75006|NCT02304003|"     Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is     more effective than standard care in patients referred for arthroscopic surgery of the     shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain,     improve shoulder function and reduce the need for subacromial decompression surgery of the     shoulder compared to standard care/wait and see controls.   "
75007|NCT02303990|"     Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in     combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who     have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who     have have progressed after at least one regimen of systemic therapy (breast, pancreas, and     other).   "
75008|NCT02303977|"     The main purpose of this study is to see how well the combination of Abraxane and gemcitabine     works in people with advanced adenocarcinoma NSCLC who have already had treatment for their     disease. Gemcitabine and Abraxane are FDA approved chemotherapies; however, the FDA has not     approved this combination in the treatment of this specific type of cancer. Patients may     continue to receive the study drugs until their disease gets worse or they have unacceptable     side effects.   "
75009|NCT02303964|"     Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal     Saline (NS) (standard of care) before arrival at the hospital.      The purpose of this study is to determine if prehospital administration of thawed plasma can     reduce mortality of patients who have lost a large amount of blood due to their injuries,     compared to those receiving standard of care.   "
75010|NCT02303951|"     Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with     vemurafenib + cobimetinib in patients with limited metastasis of melanoma in stage IIIC/IV     melanoma.   "
75011|NCT02303938|"     The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility     and to determine the effect size of an exercise program in improving objective cognitive     functioning.   "
75013|NCT02303912|"     A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used     in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which     reappear after standard cancer treatment. The aim of the trial is to determine safety,     effectiveness, and clinical activity of this combination treatment.   "
75014|NCT02303899|"     This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate     in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by     Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient     refusal or withdrawal of patient consent, or unacceptable toxicity   "
76833|NCT02280135|"     The purpose of this study is to evaluate the safety of intravitreal injection of autologous     bone marrow stem cells in patients with retinitis pigmentosa by a prospective, single-center,     randomized, parallel, double-blind, phase I placebo-controlled clinical trial.   "
75015|NCT02303886|"     Aim of Investigation Methylene blue (MB) is a diaminophenothiazine with antioxidant,     anti-inflammatory properties and with inhibitory effects on nitric oxide. The aim of this     study was to determine the clinical effectiveness of MB in the treatment of neuropathic pain.      Methods Ten patients with neuropathic pain were randomized to receive one of the two     treatments: methylene blue (MB1) 2 mg/kg (10 mg/mL Methyltioninklorid, Apoteket, Umeå,     Sweden) or methylene blue (MB2) 0.02 mg/kg. Both MB solutions were infused intravenously over     60 minutes. The sensory function and the pain were evaluated at baseline and at 60 min after     the start of infusions. A pain journal was kept by the patients in the following 5 days.     Plasma and urinary concentrations of 8-isoprostane-prostaglandin F2α (8-iso-PGF2α) an     indicator of oxidative injury, were measured with radioimmunoassay (RIA). A panel of 92     proteins biomarkers were determined with Proximity Extension Assay (PEA) prior and after     infusions.      comparison with the control group. MB infusion produced an enhancement of prolactin.   "
75016|NCT02303873|"     Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI)     because it significantly increased areal bone mineral density (BMD) and its Z score,     decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted     beneficial roles in different age brackets, especially in young patients with OI.   "
75017|NCT02303860|"     The purpose of this study is to evaluate ORM-12741 concentrations in blood at steady state.   "
75018|NCT02303847|"     This project is a pilot study to evaluate the analgesic and opioid-sparing effects of     ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of     chronic non-cancer pain in opioid-tolerant patients in the primary care outpatient setting.   "
75019|NCT02303834|"     Study design:      Single blinded randomised control trial      Planned sample size:      30 (women randomized 2:1 to receive either CPAP or no CPAP)      Objectives:      Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures     and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia.      Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal     well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep     studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR     monitors.      Study Procedure:      Participants will be recruited from the antenatal ward or high-risk antenatal clinic.     Following informed consent participants will be randomly assigned to receive either CPAP or     no CPAP for one night, following an initial baseline overnight sleep study.      Baseline- Night 1        1. Sleep study with fetal movement and HR monitor        2. 24 hour BP monitor        3. CO2 monitor      Intervention- Night 2 (Nasal CPAP device or no CPAP)        1. Sleep study with fetal movement and HR monitor        2. 24 hour BP monitor        3. CO2 monitor      Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks     post-partum related to the participant's personal health, their child's birth details and     health.   "
75020|NCT02303821|"     The purpose of the study is to determine the maximum tolerated dose and assess the safety,     tolerability and activity of carfilzomib, alone and in combination with induction     chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).   "
75021|NCT02303808|"     This trial aims to analyze whether the inhalation of hypertonic saline combined with a     positive expiratory pressure (PEP) device increases the amount of sputum expectorated during     the chest physiotherapy session ( inhalation + bronchial drainage).   "
75022|NCT02303795|"     RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).   "
75023|NCT02303782|"     This study is designed in its first part (phase Ib) to determine the recommended dose of the     OTX015 + Vidaza (azacitidine) combination in newly diagnosed acute myeloid leukemia patients     not candidate for standard intensive induction therapy.      It will be followed by a randomized phase II part to assess the efficacy of the combination     using 2 arms : Vidaza (azacitidine) alone vs. OTX015 in combination with Vidaza     (azacitidine).   "
75024|NCT02303769|"     Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet     in benign prostatic hyperplasia patients with lower urinary tract symptomatic   "
75025|NCT02303756|"     The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection     of neoplasms compared to conventional colonoscopy in persons participating in the Danish     screening program for colorectal cancer with a positive fecal occult blood with the     colonoscopy being the gold standard.   "
75026|NCT02303743|"     Getting ready for a colonoscopy is difficult and involves a lot of steps. The information     given to patients is very important to adherence to treatment. The investigators have created     a novel smart phone application (SPA) aimed to increased bowel preparation quality and     patient satisfaction, using different educational tools.   "
75027|NCT02303730|"     The purpose of this study is to evaluate whether exenatide is superior to insulin glargine     (after 24 weeks) in reducing liver fat content (by MRS) in patients with newly diagnosed type     2 diabetes mellitus and concomitant non-alcoholic fatty-liver disease(NAFLD).   "
75028|NCT02303717|"     A prospective, randomized, multicenter study in patients with an indication for coronary     artery revascularisation who have been accepted for percutaneous coronary intervention (PCI)     of the left main coronary artery. Patients will undergo standard PCI of the left main     coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE     stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm     whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients     will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after     treatment.   "
75029|NCT02303704|"     In spite improvements in methods of myocardial protection, peri-operative myocardial damage     is still the commonest cause of early morbidity and mortality after technically successful     CABG Surgery. What is the optimum method of myocardial protection is still debatable.      The investigators conducted this study to see effects of multiport antegrade cold blood     cardioplegia on myocardial protection, along with continuous controlled warm blood perfusion     through veins graft during proximal ends anastomosis in conventional CABG surgery in patients     having multi-vessel disease.   "
75065|NCT02303236|"     Establishing the association between biological markers and exercise capacity in     continuous-flow left ventricular assist device patients.   "
75030|NCT02303691|"     This project seeks to identify neural mechanisms underlying the tendency for anxious     individuals to pay more attention to threatening information than to other types of     information. A computerized treatment designed to train individuals to reduce their attention     towards threat will be tested, with a focus on understanding the aspects of brain function     that predict response to the treatment. This work could ultimately lead to the ability to     treat anxiety more effectively by directly targeting the aspects of brain function that are     altered in a given patient.   "
75031|NCT02303678|"     This is a Phase I study to determine the maximum tolerated dose (MTD) of D2C7-IT (D2C7     Immunotoxin) when delivered intratumorally by convection-enhanced delivery (CED) to recurrent     World Health Organization (WHO) grade III (dose escalation only) and IV (dose escalation and     dose expansion) malignant glioma patients, and to determine what dose will be considered in a     single-arm Phase II trial. Patients with recurrent WHO grade III (dose escalation only) and     IV (dose escalation and dose expansion) malignant glioma who meet eligibility criteria will     be enrolled into the study. Immediately following stereotactically-guided tumor biopsy,     subjects will have catheters inserted. If the frozen section of the biopsy indicates a proven     diagnosis of recurrent malignant glioma (diagnosis results are typically received within     24-48 hours following biopsy), the investigators will proceed with the D2C7-IT infusion. If     not, the catheters will be removed. A continuous intratumoral infusion of D2C7-IT will be     administered and the same total flow rate for all catheters will be set at 0.5 ml/hour per     catheter for 72 hours.   "
75248|NCT02300844|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in     normal weight, overweight to obese but otherwise healthy male subjects.   "
75032|NCT02303665|"     Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on     women with ART Failure; to compare the curative effect of the dual therapy and triple therapy     on women with ART Failure; to choose the best TCM interventional therapeutic plan.      Methods: The cases with ART Failure from West China second University Hospital of Sichuan     University (West China Women's and Children's Hospital of Sichuan University) meeting the     inclusion criteria were randomly divided into three groups: the dual therapy group, the     triple therapy group and the control group, compare the natural pregnancy number, the     condition during the period of secondary IVF-ET and the improvement of the kidney deficiency,     liver depression and blood stasis syndrome among those three groups.   "
75033|NCT02303652|"     This study aimed at evaluating multiple aspects of biatrial contractility recovery after     modified maze procedure during mitral valve surgery.   "
75034|NCT02303639|"     The study evaluates whether catheter based radiofrequency ablation is superior to optimized     antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients     with ischemic heart disease and implantable cardioverter defibrillator.   "
75035|NCT02303626|"     This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing     acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be     randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will     compare the number of acute attacks in each treatment group, as well as a number of other     clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to     placebo.   "
75036|NCT02303613|"     Background: Triage in the emergency department (ED) together with initial assessment is used     to identify patient's level of urgency and treatment based on their triage level. Triage in     the ED is a complex decision-making process, and several triage scales have been designed as     decision support systems to guide the triage nurse to a correct decision. Worldwide there are     four well known five-level triage systems in use. In 2010, 97% of all EDs in Sweden     introduced a process-oriented triage scale with physiological parameters called Rapid     Emergency Traige and Treatment System (RETTS). RETTS has two main assessment variables: vital     signs and chief complaints, which describe the incident or symptoms that caused the patient     to seek care. These two variables are evaluated and results in a color coded 5-level scale.     Each level of priority has a defined time limit within which evaluation by a doctor should     begin. Although, all international triage system guidelines seem to function well in western     countries, they are difficult to implement and have a high failure rate in developing     low-income countries. One of the reasons may be the lack of extensive training. Teaching and     assessing abilities in performing mass casualty triage in inherently challenging due to the     inability to accurately replicate a given disaster environment in a comprehensive way.     Disaster drills and simulation exercises are ways of training triage performance and there     are different tools available. One tool that can contribute to this kind of training may be     the Emergo Train System® (ETS). ETS or similar interactive educational simulation systems     could be used to test and evaluate incident and command systems, surge capacity, hospital     preparedness and triage.      Study objective study III: The aim of the study is to validate the currently practiced system     for triage in the ED in Moi Teaching and Referral Hospital in Eldoret, Kenya with RETTS.     Furthermore map the current patient outcome of trauma patients.   "
75037|NCT02303600|"     Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology     and wide-ranging. Cough is usually divided into three categories by time: acute cough,     subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main     etiology is postinfectious cough, which is mostly secondary to viral infection.Considering     its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in     gathering eosinophils to respiratory. The level of FENO has a significant correlation with     inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may     increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway     inflammation and decrease airway high activity by suppressing the biological activity of     CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the     course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO     can be used as a biomarker to optimized treatment regimen of sub-acute cough.   "
75038|NCT02303587|"     The study is designed to investigate difference in percentage of presentation of atelectasis,     bronchiectasis, bronchiolitis obliterans, or consolidation in 6 months after discharge in     those treated with a low dose regimen of methylprednisolone initiated with 2 or 4 mg/kg/d for     3 days followed by tapering, combined with sequential treatment with azithromycin versus a     high dose regimen of methylprednisolone initiated with 10 mg/kg/d for 3 days followed by     tapering, combined with sequential treatment with azithromycin.   "
75039|NCT02303574|"     This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the     safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and     multiple oral doses of AZD7986 in healthy volunteers   "
75066|NCT02303223|"     The principle objective of this study is to evaluate pharmacokinetics of propofol after     single iv bolus dose in 12 Indian children and to develop a simple pharmacokinetic model of     propofol.   "
75067|NCT02303210|"     The purpose of this study is to examine two frequency lowering techniques in case of     audibility, recognition, distinction, discriminability and sound quality.   "
75040|NCT02303561|"     Overweight and obese (OV/OB) children with asthma are at-risk for particularly poor health     outcomes including poor asthma control, higher risk of asthma-related symptoms, and decreased     quality of life. Weight loss reduces asthma symptoms, improves lung function, and increases     quality of life among OV/OB adults with asthma. Little research has examined the impact of     weight loss on asthma outcomes in OV/OB youth, and there is little research examining weight     management interventions in OV/OB children with asthma. Behavioral family-based lifestyle     interventions are successful in producing weight loss in children. To our knowledge, however,     there has been no systematic effort to examine the impact of these interventions on weight     status and asthma outcomes, nor has there been an effort to tailor these programs to the     specific needs of OV/OB children with asthma.      The aims of this study are to develop and test the Childhood Health and Asthma Management     Program (CHAMP), a behavioral family-based lifestyle intervention that is community-based to     promote successful weight and asthma management in OV/OB children with asthma. The     investigators propose to develop an intervention based on a previously developed behavioral     family-based lifestyle intervention that was community-based and produced positive long term     weight status changes in OV/OB children and tailor it for OV/OB children with asthma to     create CHAMP. CHAMP will include asthma education and targeting unique barriers to weight     management in OV/OB children with asthma. A focus group will be conducted with OV/OB children     with asthma, ages 6-12, and their parent(s). Then a pilot randomized controlled trial of the     CHAMP intervention with 32 OV/OB children with asthma, ages 6-12 years, and their parent(s).     Families will be randomly assigned to CHAMP or a health education group. The investigators     hypothesize that participants in CHAMP will have more effective weight and asthma management     and child asthma outcomes compared to those in the general education group.   "
75041|NCT02303548|"     A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary     resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.   "
75175|NCT02301806|"     To investigate whether single administration of sitaglitpin can restore acute endothelial     dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells     (EPCs) after oral glucose loading in patients with T2DM.      To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by     flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.   "
75042|NCT02303535|"     The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces     analysis to enable hospitals and healthcare improvement bodies to monitor and improve the     quality of care and outcomes of cardiovascular patients.      The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic     cardiac catheterisations procedures used to treat patients with congenital and acquired heart     disease.      For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients     less than 16 years old only. For congenital heart disease, the audit collects data on both     children and adult patients. The audit covers all specialist centers in the UK and Republic     of Ireland.      The project aims to improve the quality of care for children and adults with congenital heart     disease by providing national comparative analysis of procedure specific activity and     outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit     also provides quality indicators for the antenatal detection of major congenital heart     disease.      The current dataset is available from here:      http://www.ucl.ac.uk/nicor/audits/congenital/datasets   "
75043|NCT02303522|"     An historical data comparator study for children with relapsed/refactory acute lymphoblastic     leukemia (ALL).   "
75044|NCT02303509|"     To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses     of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study     uses healthy and psoriasis subjects.   "
75045|NCT02303496|"     Human skin undergoes some morphological changes with the effects of chronological aging and     photoaging, these are especially remarkable in the facial skin. Changes in pigmentation,     sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and     chronologic aging of skin. With the increasing demand, it needs to provide new approach for     the prevention and treatment of these morphological changes.      Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates     the fibroblasts and increases the synthesis of collagen and other type of matrix components.     Because of these specialities, platelet rich plasma is thought to be effective on skin aging.   "
75046|NCT02303483|"     In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism.     It is currently not know if vitamin B3 has the same positive effects in humans. In the     current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and     substrate metabolism in obese men will be investigated.   "
75047|NCT02303470|"     This study evaluates the feasibility and metabolic effects of implementing a structured     exercise program in women with polycystic ovary syndrome and insulin resistance. Participants     will be randomized to either 75 minutes of vigorous exercise or 150 minutes of moderate     exercise per week.   "
75048|NCT02303457|"     Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic     carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.   "
75049|NCT02303444|"     The purpose of the study is to assess the use of Multikinase Inhibitors (MKIs) in the     treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to     radioactive iodine (RAI) who do not have any symptoms.   "
75050|NCT02303431|"     This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a     single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy     to see what the body does to the drug (pharmacokinetics) and what the drug does to the body     (pharmacodynamics), and to compare if these effects are similar to those observed in adults.   "
75051|NCT02303418|"     The study aims at comparing the roles of carbetocin and oxytocin in the prevention of atonic     PPH in women undergoing CS for placenta previa.      200 women will be randomly divided into 2 equal groups using computer generated random     numbers, Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).   "
75052|NCT02303405|"     A 4-month, randomized, prospective, open-label comparison trial of hydroxychloroquine vs.     pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses     of metformin plus a sulfonylurea.   "
75053|NCT02303392|"     This phase I trial studies the side effects and best dose of selinexor when given together     with ibrutinib in treating patients with chronic lymphocytic leukemia or aggressive     non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to     treatment. Drugs used in chemotherapy, such as selinexor, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Giving selinexor together with ibrutinib may be a     better treatment for chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma.   "
75054|NCT02303379|"     It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried     out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance     training, on changes of physical exercise capacity in cardiac patients.   "
77785|NCT02267707|"     The purpose of this study is to determine the safety and pharmacokinetic profile of     nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who     have cholestatic hyperbilirubinemia secondary to bile duct obstruction.   "
75055|NCT02303366|"     This is a prospective, observational pilot study that will describe the safety profile and     biological effects of combining stereotactic ablative body radiosurgery (SABR) treatment     (20Gy/1#) and a PD-1 antibody, MK-3475.      15 patients with oligometastatic breast cancer with at least one lesion considered safe for     SABR radiotherapy, will be treated with SABR for their oligometatastic disease in addition to     6 months of MK-3475 treatment (1 cycle every 3 weeks, a total of 8 cycles).      This investigator driven pilot study will examine the safety and biological effects of     combining MK-3475 (Pembrolizumab) an antibody targeted against the anti-programmed cell death     1 (PD-1) T cell checkpoint, with SABR therapy for oligometastatic disease. We hypothesise     that the safety profile of this combination, will be clinically acceptable and well tolerated     for patients, and that we will observe evidence of systemic immune activation.   "
75290|NCT02300298|"     To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75     mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area     (BSA) <1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung     cancer (NSCLC) after failure of first line platinum- based chemotherapy   "
75056|NCT02303353|"     The purpose of this registry is to evaluate the situation regarding ambulant therapy of     cancer patients in different practices in Germany. It should provide insight into the     implementation of schemes for cancer therapy predefined in the guidelines, the treatment of     diverse adverse reactions and the counter measures taken. Thereby, potential differences in     treatment and with that differences in quality amongst individual practices might be     identified. The medium to long term aim is to contribute to positively influence the quality     of medical care of cancer patients in Germany.   "
75057|NCT02303340|"     The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography     (CBCT) in assessment of bone density. The study population contains men and women above the     age of 60 years, eligible for Bone Density Testing in accordance with their health insurance,     who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible     for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or     both) due to dental reasons, will be sent to a bone mineral density DEXA Scan, and for blood     testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels.      Density measurements will be done in specific sites on the CBCT's of the jaws. These     measurements will be correlated with the blood tests and DEXA scan results.   "
75058|NCT02303327|"     In North America, the number of new cases of prostate cancer increases every year. Many     efforts have been made to develop more efficient and safer curative treatments for high risk     prostate cancer patients.      This phase III clinical trial is designed to compare the safety of a standard pelvic external     beam radiation therapy (EBRT) combined with a high dose rate brachytherapy (HDRB) boost     (direct insertion of radiation source over a period of minutes via flexible needles     temporarily inserted in the prostate) to a shorter course of hypofractionated dose escalation     radiotherapy (larger radiation dose per daily treatment) in patients with high risk prostate     cancer.      The investigators plan to recruit 296 patients across Quebec who will be randomized in either     treatment plan.   "
75059|NCT02303314|"     This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of     non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients     select and then randomize into intervention and control groups. Two group use capsules which     contain TFG or placebo, respectively.   "
75060|NCT02303301|"     Hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in their     oropharynx Increased risk of pneumonia due to the pathogens in the oropharynx Probiotics can     reduce such bacteria in intubated critically ill patients This study will use two strain of     probiotic bacteria for half of the patients and a placebo for the rest Active arm gurgles     with a suspension twice a day Cultures at inclusion and at set time intervals The results of     cultures from the two groups will be compared as will the use of antibiotics   "
75061|NCT02303288|"     This is a post-market study of the Argus II Retinal Prosthesis System. The study is being     conducted in France. The objective of the study is to obtain data to further demonstrate the     effectiveness and evaluate the safety of Argus II System in patients with retinitis     pigmentosa who have a bare light perception or worse in both eyes.   "
75062|NCT02303275|"     Summary      Chronic heart failure continues to be one of the highest economic burdens in the United     States, heavily influenced by frequent readmissions to the hospital. This study will examine     whether patients 65 years and older, who have NYHA class II and III heart failure, will     improve their symptoms after participating in a comprehensive 12-week lifestyle change     program. The investigators will recruit potential subjects primarily from the Scripps Clinic     heart failure clinic at the Torrey Pines campus. Qualifying subjects will be randomized to     medical treatment as usual or the lifestyle program. The investigators will enroll 17     subjects into each group which will provide 80% power and an alpha of 0.05.      The lifestyle change program consists of classes conducted three times a week for 12 weeks at     the Scripps Center for Integrative Medicine. Each day participants will spend about four to     five hours in a variety of classes such as monitored exercise, group support, mindful-yoga     and meditation, vegetarian cooking classes, music-centered wellness, mind-body lectures, and     resiliency training.      The primary outcomes will focus on determining functional status and physical agility using     the 6-minute walk test, handgrip strength, and NYHA class categories. In addition, the     investigators will capture subjective physical status with a self-reported questionnaire.     Cognitive assessment will be performed using the Montreal Cognitive Assessment tool. To     capture the subject's overall self-reported improvement the investigators will use a quality     of life and a depression questionnaire. Secondary endpoints include hospital admission rates     and all-cause mortality.   "
75063|NCT02303262|"     The purpose of this study is to assess the response rate (per RECIST 1.1) in participants who     receive mocetinostat and gemcitabine after documented progression of leiomyosarcoma on a     gemcitabine containing regimen.   "
75064|NCT02303249|"     The study aims to assess whether the review of discharge planning followed by a     cross-sectoral video conference in connection with discharge of medical and geriatric     patients at Roskilde and Køge hospitals as well as patients from the Emergency Department at     Køge Hospital reduces the proportion of patients who are readmitted within 180 days.      Project nurses at the two hospitals identifies all patients fulfilling the inclusion criteria     (above 55 years of age, discharged to their own home), get informed consent and performs the     video conferences. Within a few hours after discharge a video conference is held in the     patient´s home including the patient,the municipal nurse and the project nurse at the     hospital. During the video conference the discharge is reviewed using a structured     assessment.      The survey is conducted as an open, randomized intervention study.   "
75069|NCT02303184|"     A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to     evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA,     triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT)     injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein     occlusion (RVO).   "
75070|NCT02303171|"     Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of     using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with     antiphospholipid syndrome (APS)   "
75802|NCT02293629|"     This is the first clinical study with the BMS-986147 compound in healthy subjects. The     purpose of this study is to guide the dose range and dose frequency for future studies with     BMS-986147 and will provide guidelines for selection of a potentially effective dose in     patients.   "
75071|NCT02303158|"     It is currently accepted that depression during midlife is a risk factor for Alzheimer's     disease (AD). Furthermore, several prospective population studies have demonstrated that     depression is an independent risk factor for incident dementia of different types (e.g.     vascular, mixed, Alzheimer's disease). However, it is not clear, what are the mechanisms that     link depression and dementia, and if depression can be a prodromal manifestation of AD. There     are also studies that suggest that depression could be an initial sign of AD.      Objective:        1. Demonstrate that late life depression (over 60 years of age) constitutes the first          manifestation of AD.        2. Define by rating scales and life stressors have differential risk profiles evolutionary          AD.        3. To study the relationship between the subtypes of depression and CSF biomarkers,          neurophycological test and evolution to AD.   "
75072|NCT02303145|"     The proposed study seeks to evaluate the relationship between biopsychosocial functioning and     work-related cognitive limitation among employed breast cancer survivors in a cross-sectional     study with healthy control group. Specifically, this study will assess work-related cognitive     limitation in association with depression, anxiety, pain, fatigue, sleep disturbance, and     cognitive deficit of employed women with and without history of breast cancer. The primary     purpose of this study is to assess the impact of objective cognitive functioning as a better     predictor of cognitive shortcomings at work place in comparison to a self-report cognitive     measure. The secondary purpose is to assess work related cognitive limitation in breast     cancer survivors in comparison to their counterparts (employed women without history of     cancer diagnosis). The third purpose is to explore how sociodemographic variables such as     marital status, education, age, race, and ethnicity relates to perceived cognitive limitation     at work among breast cancer survivors. Additionally, the study will examine the effects of     medical variables as covariates on these relationships. Subsequently, the study will examine     the level of mindful attention and awareness as a possible mediator between the     psychological, somatic and cognitive distress and the work-related cognitive limitation.      In this observational study, the control group is added as a mean to compare differences     between groups and that no variables is being manipulated in this study. This precludes this     research from being a quasi- or a true experimental design.   "
75073|NCT02303132|"     Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor     for MC development. However, the exact pathophysiological mechanism is unclear. It is     hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due     to an idiosyncratic reaction which results in a local immune response. MC patients are     considered to be susceptible hosts, prone to react on administration of abovementioned drugs.     In order to test this hypothesis and to generate new insights in the pathophysiology of MC,     we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary     objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of     colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system   "
75074|NCT02303119|"     Patient will receive either one infusion of rituximab IV and seven administrations of     rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).      The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of     administration could:        -  optimize rituximab exposure leading to improve response rate        -  increase adaptative response and then improve long-term control disease.   "
75075|NCT02303106|"     The investigators will study the effect of paracetamol on the steady state metabolism of     lamotrigine in 12 healthy male volunteers.      Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28     days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject     will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be     repeated.      Primary outcome parameter is Lamotrigine AUC before and after coadministration of     paracetamol.   "
75076|NCT02303093|"     Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%   "
75077|NCT02303080|"     The main objective of the trial is to measure the thermogenic effect of two different doses     of whey protein microgels.      It will be a randomized crossover double-blind design conducted in 20 subjects.   "
75078|NCT02303067|"     Background:      - This study is designed for people who need a standard, non-research invasive coronary     angiogram to find out if they have heart disease. Researchers want to take a computed     tomography (CT) scan of people s hearts before their procedure to see if this less invasive     test can also diagnose coronary artery disease.      Objectives:      - To learn if a new way to view CT pictures is able to accurately diagnose coronary artery     disease.      Eligibility:      - People age 55 and older who need a coronary angiogram.      Design:        -  Participants will be screened with their medical records.        -  Participants may give a blood sample.        -  Participants may have a CT scan of the heart with and without contrast. The CT scan will          not interfere with their medical care.        -  Participants blood pressure and heart rhythm will be monitored before, during, and after          the CT scan. They may have an electrocardiogram.        -  Before the scan, participants will have an intravenous catheter put into their arm. It          will be used to inject contrast.        -  Participants may take a beta blocker to slow their heart rate.        -  Participants may take nitroglycerin under their tongue. It will enlarge their heart          blood vessels and improve picture quality. It may cause a flushing sensation or          headache.        -  Participants will lie on their back on a padded table. The table slides into a large,          donut-shaped machine. An x-ray tube will move around their body, taking pictures. They          will be asked to hold their breath for 5 seconds at a time.        -  Participants will be called 30 days after their angiogram. They will answer questions          about their health, hospital visits, or medical treatments.   "
75079|NCT02303054|"     This is a prospective single center trial to examine the rate of negative biopsy result and     quality of life after focal ablation by radiofrequency energy. The primary evaluation     involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months     after focal ablation of the prostate. Urinary and sexual quality of life will be assessed     through validated measures. The hypothesis of our study is that focal ablative therapy will     result in a greater likelihood of negative biopsy on followup biopsy than that observed in     men who elect not to undergo therapy.   "
85518|NCT02166671|"     This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine     booster in healthy adults which received a full course of neonatal hepatitis B vaccination     20-23 years ago.   "
75081|NCT02303028|"     This is a phase I, dose escalation study where topotecan will be administered at lower doses     given more frequently on a prolonged schedule (low dose metronomic; LDM), in combination with     a fixed dose of pazopanib. The maximum tolerated dose (MTD) and the recommended phase 2 dose     (RP2D) will be evaluated for LDM topotecan in combination with pazopanib in children with     recurrent or refractory solid tumours including CNS tumours. Pharmacokinetic and     pharmacodynamic studies will be conducted to further define the exposure to and activity of     LDM topotecan in combination with pazopanib.   "
75082|NCT02303015|"     The purpose of this study is to identify genetic variations in survivors of testicular cancer     and connect these variations to differences in risks of late effects.   "
75083|NCT02303002|"     This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar     frown lines.   "
75084|NCT02302989|"     To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related     Macular Degeneration   "
75085|NCT02302976|"     The investigators plan to explore the effects of acute pre-treatment with the glucagon like     peptide-1 (GLP-1) agonist, exenatide versus placebo, on the subjective (e.g., euphoric) and     behavioral effects (e.g., self-administration) of cocaine in experienced, non-treatment     seeking users of the drug. Additionally, the investigators plan to explore the effects of     sub-chronic (5-day) treatment with exenatide as compared to placebo on the subjective (e.g.,     euphoric) and behavioral (self-administration) effects of cocaine in experienced,     non-treatment seeking users of the drug.   "
75086|NCT02302963|"     This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop     versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type     1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.   "
75087|NCT02302950|"     Raltegravir is the first marketed strand-transfer inhibitor of HIV-1 that was FDA approved in     2007. It is currently one of the preferred treatment regimens for HIV by the Department of     Health and Human Services. It has become a widely used antiretroviral therapy option for HIV     infected patients. It provides good tolerability and a favorable lipid profile for patients     when compared to some other antiretroviral treatment options. Little data is reported about     efficacy in a minority patient population. Moreover, data in an indigent minority population     in the United States has not been aggregated before. Therefore this study will investigate     the efficacy of raltegravir in minority women residing in Houston, TX who are HIV infected.   "
75088|NCT02302937|"     This study is carried out to determine if laparoscopic inguinal TEP repair of the hernia     using a mesh carried out with only 1 port (hole) results in the reduction of post- operative     pain and use of painkillers, shorter hospital stay and lesser complications than that carried     out using conventional 3 ports.   "
75089|NCT02302924|"     There is no standardized method for evaluating the symptoms of influenza. A standardized     instrument for measuring influenza symptoms, with appropriate scientifically derived content     and construct validity would have value for public health in terms of use as a validated     outcome measure in interventions to treat or prevent influenza. The instrument also could     serve as part of an overall measure of severity of illness in influenza. Previous efforts in     participant reported outcomes (PRO) for influenza (i.e. Flu-PRO Stage I and Stage II) focused     on the elicitation and evaluation of items for inclusion in the instrument. The overarching     objective of this protocol - Flu-PRO Stage III - is to conduct instrument validation to     evaluate item properties and, if need be, reduce the number of items, and quantitatively     validate the performance of the final measure.   "
75090|NCT02302911|"     This study aims to investigate the effectiveness of early (before the age of 5 years) and     intensive intervention for children with Autism Spectrum Disorders.   "
75091|NCT02302898|"     This study compares eating behaviors, meal size, and the size of the gastric pouch and     connection between the gastric pouch and small intestine in patients who had gastric bypass     surgery two or more years ago and regained weight compared with patients who had gastric     bypass surgery two or more years ago and maintained their weight loss.   "
75092|NCT02302885|"     Human blood will be collected to serve as control in validating clinical studies studying the     detection and levels of circulating tumor cells and microvesicles in cancer patients.     Targeted population is cancer-free 18-60 year old men and women. Volunteer selection will     rely upon a short health questionnaire. About 20 mL blood will be collected from volunteers     up to 20 different timepoints. The Procedure involves minimal risk of harm (eg discomfort,     bruising) to the volunteer.   "
75093|NCT02302872|"     The objective of the study is to evaluate the safety and performance of the ARTO System in     patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).   "
75094|NCT02302859|"     The goal of this research study is to learn about 2 different interactive methods that are     designed to help people with HIV/AIDS stop smoking.   "
75095|NCT02302846|"     The goal of this clinical research study is to learn if ixazomib can prevent AML or MDS from     coming back in patients who are in remission. The safety of this drug will also be studied.   "
75096|NCT02302833|"     The goal of this clinical research study is to learn if cabozantinib can help to control     advanced or metastatic pheochromocytoma or paraganglioma. The safety of this drug will also     be studied.   "
75097|NCT02302820|"     This study begins to look at ways nurses in primary care might help patients engage in     Advance Care Planning and communicate their values and preferences to family and doctors.   "
75098|NCT02302807|"     This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study     designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in     participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have     progressed during or following a platinum-containing regimen. The anticipated time on study     treatment is based on continued clinical benefit, i.e., until disease progression or     unacceptable toxicity. The target sample size is 932 participants.   "
75099|NCT02302794|"     evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach     distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current     standard surgical treatment model D2 open approach distal gastric resection (distal     gastrectomy, D2 lymphadenectomy).   "
75100|NCT02302781|"     Dropout rates for fertility treatments are high. This study will examine the rate of patients     that drop out during any type of subfertility work up or treatment. Furthermore, we will     determine what reasons for discontinuation are and we will identify the demographic     characteristics of the couples and the prognostic factors for drop out during assessment or     treatment at a Fertility Centre in the Isala (Zwolle), Erasmus University Centre (Rotterdam),     Elisabeth Twee Steden Hospital (Tilburg), Reinier de Graaf Group (Voorburg), St Antonius     Hospital (Nieuwegein), Maxima Medical Centre (Veldhoven) and Noordwest Hospital Group (Den     Helder/Alkmaar) in The Netherlands.   "
75101|NCT02302768|"     Over the past 10 years, several clinical studies have suggested that selenium supplementation     may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible     chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of     this prospective, randomized, controlled study is to evaluate the effect of two different     doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in     terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity,     over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor     necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of     AIT patients are also evaluated.   "
75102|NCT02302755|"     The purpose of this study is to evaluate the safety of repeated TP10 dosing in pediatric and     adult patients with C3G and to evaluate the activity of TP10 in pediatric and adult patients     with C3G, as measured by the proportion of patients with normalization of serum C3, serum C3     breakdown products, or alternative pathway (AP) complement activity.   "
75103|NCT02302742|"     PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who     have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).   "
75104|NCT02302729|"     Over 200 million children under the age of 5 years in low and middle-income countries do not     reach their developmental potential, largely due to lack of adequate nutrients and lack of     psychosocial stimulation. Stunting (length-for-age < -2 z-scores) is an indication of chronic     undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere (over     40%). This trial examines the effect of providing a micronutrient powder manufactured in     Guatemala vs. placebo and an early learning environment vs. no early learning environment on     the growth, health, and development of young children in Guatemala.   "
75105|NCT02302716|"     The main purpose of this study is to evaluate the safety and efficacy of the study drug known     as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or     more oral antihyperglycemic medications (OAMs).   "
75106|NCT02302703|"     Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be     relieved with defecation and a change in stool frequency and consistency. Its prevalence     among children and adolescents is estimated to be 10-15%. Non-Celiac Gluten Sensitivity is     defined as gastrointestinal symptoms which increase with eating gluten-containing foods and     improve with a gluten-free diet. FODMAP (fermentable oligo-,di-,mono-saccharides and polyols)     are carbohydrates that are not absorbed well in the small intestines, therefore fermented by     gut microbiota, increasing osmotic load at the intestine causing fluid shift and gas     production. The patient suffers bloating, abdominal pain, flatulence and change of stool     consistency. Many foods are FODMAP-rich, including fruit and vegetables, legumes, artificial     sweeteners and soft drinks.      Working hypothesis and aims: To study the effect of Low FODMAP diet vs. Gluten free on     gastrointestinal symptoms in children with IBS, assuming a beneficial effect based on     research in adults.      Methods: 40 children with IBS, aged 6-18 years, will be examined by the pediatric     gastroenterology team at Hadassah. All children will record one week of baseline diet and     symptoms, then will be randomly selected into a low-FODMAP or Gluten-free diet for one week,     together with a washout period of one week between the diets. During the two weeks of     intervention diets, the children aided by their parents will document and score symptoms     (bowel movements, abdominal pain, flatulence). An analysis of the symptom score will measure     the anticipated influence of each diet against baseline diet and symptoms.      Expected results: In previous studies, a change in symptoms was viewed within a few days. We     expect to see a reduction of symptoms in one or other of the diets, to prove our hypothesis.   "
75107|NCT02302690|"     The proposed research protocol aims at addressing these points by pre-screening CN patients     for their AAV serology in link with their medical history and current medical status. A first     objective is to assess the presence of neutralizing AAV antibodies in the serum of CN     patients.   "
75123|NCT02302482|"     The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases     because of their main features such as cognitive impairment, loss of functional autonomy and     behavioural disorders. In absence of current curative treatment, the identification of the     predictive risk factors of progression of the disease, evaluated through its main symptoms,     represents a major stake of public health. The investigators aimed at developing a database,     which includes the patient medical records on a prospective basis, in collaboration with the     medical and administrative personal and with the University hospital computer science     department. The main objective is to study the predictive factors associated with the change     of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory     Clinic. The study population would consist in about 1000 patients with ADRD. The length of     follow-up of each patient will be 3 years.   "
75124|NCT02302469|"     The purpose of this study is to determine the recommended dose of lenalidomide in subjects     with relapse and refractory Waldenstrom Macroglobulinemia.   "
75174|NCT02301819|"     Eligible patients with severe cardiogenic shock will be randomized to one of the two arms:     immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial     ECMO will be implanted according to the local practice with flow settings to ensure     sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group,     all other diagnostic and therapeutic procedures will be done according to the current     standard of care at the tertiary cardiovascular center, including other cardiovascular     interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of     other mechanical support devices including ECMO in the primary conservative group is allowed     in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with     the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and     12 months.   "
75108|NCT02302677|"     This is a prospective study of meal-induced bile acid physiology before and after sleeve     gastrectomy (SG) surgery. Weight loss and metabolic improvement associated with weight loss     surgery cannot be entirely attributed to restriction in stomach size and food intake. Bile     acids (BAs), amphipathic steroids that have a role in lipid uptake and metabolism in the     gastrointestinal tract, are involved in post-prandial glucose homeostasis and energy     expenditure, and are a potential intermediary in weight loss following bariatric surgery. It     is unknown if SG increases post-prandial BAs in humans and if an increase in BA signaling     impacts weight loss and co-morbidity resolution after surgery. The investigators hypothesis     is that SG will increase the post-prandial serum and urine BAs and that the change in the BA     profile is a mechanism for restriction-independent weight-loss following SG. 32 eligible,     adult, morbidly obese human subjects will be recruited by the Clinical Research Center at     UNMC. These subjects will be evaluated in a multi-disciplinary fashion, approved, and     consented to have a SG at UNMC. Subjects will be eligible for the study if they meet these     criteria: between 19 and 70 years old, participant in the Surgical Weight Loss Program of the     Bariatrics Center of University of Nebraska Medical Center (UNMC), approved to have a SG at     UNMC, have SG as the primary bariatric surgery or prior lap band placement and removal over     two years prior to the surgery. Medical charts of participants will be reviewed and pertinent     data from time of surgery will be abstracted. Subjects will be excluded from the study if     have a past history of small bowel resection or right colectomy, cirrhosis, current or     planned use of BA sequestrants, or bariatric surgery performed as a revisional procedure. SG     patients will undergo a meal challenge pre-operatively, and at 1, 3, and 12 months     post-operatively, with measurement of post-prandial serum and urine BAs and downstream     hormones, glucagon-like peptide 1 (GLP-1) and fibroblast growth factor 19 (FGF19), and a     scoring of satiety before and after the meal challenge using a Visual Analog Scale. Serum     insulin, glucose, and C4 levels will also be measured to assess metabolic changes associated     with SG. Serum and urine BA levels will be compared to post-operative excess weight loss at     12 months. Before and after each meal challenge, patients will be asked to score satiety, and     this will be correlated to weight loss, bile acids, GLP-1, and FGF19.   "
75109|NCT02302664|"     Platelet Rich Plasma in Achilles Tendon Healing      Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit     patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles tendon     rupture (ATR)? This is a multicentre, blinded, randomised, placebo controlled trial with two     sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants.      ATR is the most common tendon injury and leads to months of incapacity. With an average work     absence of 63108 days there are significant societal and National Health Service (NHS) costs.     PRP potential benefit is to improve recovery and return to normal activities earlier, and     reduce the NHS and societal impact. The investigators will investigate the efficacy of PRP     using disease specific and patient important outcomes to improve the evidence for this     treatment of ATR.      A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214     participants. Patients will be identified in the orthopaedic outpatient clinic, usually     following an emergency hospital attendance for ATR. After checking eligibility and the     informed consent process, baseline data is collected and participants randomised to either     'PRP injection' or 'Imitation (placebo) injection'. A participant's own blood sample is taken     and prepared according to allocation. The injection is delivered by a trained surgeon in     clinic who will be aware of allocation while the participant remains blind.      Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks,     carried out by a member of the research team blind to allocation. Assessments take place over     the telephone or during a hospital outpatient visit. The 24 week hospital visit includes an     exercise test of ankle function. All assessments include collection of patient reported     responses to pre-set questions.      The results may be applicable to the many other tendon and ligament injuries. The National     Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism     Evaluation Programme provides funding and University of Oxford is Sponsor.   "
75110|NCT02302651|"     Non-invasive treatment of Osteoid osteoma using MRI guided high-intensity focused ultrasound.     This study is designed as an intention-to-treat using a totally non-invasive approach for     pain reduction, quality of life improvement and long-term bone restoration. Procedure is     performed in a single session using limited amount of acoustic energy to target the osteoid     nidus. Treatment will be performed under anesthesia (peripheral or general according to age     and lesion position).   "
75111|NCT02302638|"     This prospective study with sibling oocytes will evaluate the efficiency of two commercial     single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms     of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates.     Embryos will be cultured continuously for up to 6 days under identical conditions.   "
75112|NCT02302625|"     Atopic dermatitis is an inflammatory skin disease characterized by itching, dry skin and     recurrent inflammatory eczema. It is one of the most common skin diseases and is associated     with reduced quality of life, functional impairment and sleep difficulties. The present study     aims to investigate a new exposure-based cognitive behavioral psychological treatment for the     disorder. The trial is a small scale open trial (n=25) with assessments at baseline,     post-treatment and 6-month follow-up. The primary outcome is the SCORAD.   "
75113|NCT02302612|"     Cardiovascular disease (CVD) is the leading cause of death in the U.S. Efforts to improve CVD     risk factors often fall short in complex patients with multiple co-morbid conditions, a     growing, expensive, and high-risk segment of the U.S. population. The investigators are     testing a multi-component behavioral intervention designed to help complex patients with CVD     and other concurrent chronic conditions to become more effective agents of their own care.   "
75114|NCT02302599|"     Between umbilical cord mesenchymal stem cells by the secretion characteristics, secrete a     variety of cytokines and its immune inhibition, promoted the islet cell repair and     regeneration, improve the state of high blood sugar in the body.   "
75115|NCT02302586|"     Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which     is also a predictor of chronic pain. In this study, the investigators aim to compare the     postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient     controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.   "
75125|NCT02302456|"     The purpose of this study is to assess whether the administration of a low dose of tranexamic     acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage,     in women who receive a prophylactic administration of oxytocin.   "
75126|NCT02302443|"     The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad     pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.   "
75127|NCT02302430|"     This study attempts to identify the psychological, behavioral, physiological, and hormonal     predictors and mechanisms of an individual's ability to develop cohesion in a group working     together as a team; and examine if administration of the prosocial neuropeptide oxytocin     enhances the development of team cohesion. Through a deeper understanding of the underlying     psychobiological predictors and mechanisms of team cohesion, the prospective identification     of individuals whose unique characteristics promote or inhibit the development of group     cohesion will become possible.   "
75225|NCT02301156|"     This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib     compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients     with high-risk cytogenetic features. Half of the participants will receive ublituximab in     combination with ibrutinib, while the other half will receive ibrutinib alone.   "
75116|NCT02302573|"     Abnormally invasive placenta (AIP) is defined as an abnormal placental attachment of a part     or the entire chorionic plate with penetration of chorionic villi in the myometrium and     absence of the decidua basalis. This anomaly is associated with significant maternal     morbidity and mortality as it may result in severe haemorrhage during the post-partum. It has     been demonstrated that prenatal diagnosis of AIP is essential to reduce maternal morbidity.     In a recent study of Chantraine F. et al. prenatal diagnosis of AIP leads to better outcomes,     due to fewer emergency operations and less mass transfusions. Currently, the diagnosis of AIP     is based on a combination of conventional B-mode ultrasound and MRI. However, prenatal     diagnosis of AIP remains challenging and recent reports demonstrated it is achieved in only     thirds of cases.      Contrast enhanced ultrasound (CEUS) is a non-invasive technique based on the detection by     ultrasound (US) of gas-filled microbubbles used as perfusion tracers. Intravascular     rheological properties of these bubbles are similar to those of red blood cells and they     remain entirely within the intravascular space. Previous studies have demonstrated that     microbubbles do not transfer into fetal circulation. CEUS has been used for years in many US     imaging applications (e.g. liver, kidneys and breast). In obstetrics, despite not yet     approved for clinical use, CEUS offers the opportunity to analyze anatomical placental     landmarks, improving the contrast between placenta and myometrium. In addition,     quantification parameters related to the contrast enhancement have been proposed as objective     indicators to estimate blood perfusion rates in the placental intervillous space.      The main objective of this study is to provide pre-clinical evaluation of CEUS for the     diagnosis of AIP and to try to determine if AIP are characterised by differences in     intervillous blood rheological properties. Conventional CEUS parameters will be: rise time,     peak enhancement, wash-in rate, mean transit time and wash-in area under the curve.      As this study is a pre-clinical evaluation, sample size calculation remains subjective and     imprecise. For this reason, a sample size of 100 pregnant women to be included in this     prospective study has been decided.      The potential impact of this study will be to propose a more reliable tool with both improved     sensibility and specificity compared to the combination US/MRI and therefore to reduce the     maternal worldwide burden of AIP.   "
75117|NCT02302560|"     The purpose of this prospective observational study is to investigate the changes in sleep     architecture after a hip surgery and its potential association with postoperative delirium     and postoperative cognitive dysfunctions respectively.   "
75118|NCT02302547|"     In the early 2000s, the TRILEGE© study was realized to determine if the reductive anti     retroviral strategy from an initial triple therapy (based on a protease inhibitor as the     third agent) towards a dual therapy of nucleoside analogs (in particular the association of     zidovudine +lamivudine) for patients infected by HIV and stabilized for at least 3 months     at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic     viral load, with an aim to reduce the long-term side effects of the treatment.      The afore mentioned study showed that the reductive anti retroviral strategy was a failure.     No study has as yet to revaluate this strategy, in particular in the current context of     antiretroviral treatments.      Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as     a superior intrinsic power as compared to treatments proposed in the initial TRILEGE©     study. Furthermore, the better quality of current triple therapy (as compared to that used 10     years ago) has lead to substantial viral reservoir reduction.      Currently, a small number of patients is being successfully treated in the long-term (viral     load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of     these patients have yet to be thoroughly investigated.      The patients concerned were all treated prematurely before ever passing below 200 lymphocytes     T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by     HIV DNA quantification (< 2,7 log copies/106 PBMC).      Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA     value and (3) a very good observance, the investigators emit the hypothesis that, reductive     anti retroviral strategy that would consist in changing from a conventional triple therapy     towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable     control of viral replication with the concomitant benefice of reduced antiretroviral side     effects and cost.   "
75119|NCT02302534|"     Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These     different curves may be distinguished by different physiopathologic mechanisms.      Without fully convincing model of the emergence and development of AIS, their multifactorial     nature seems evident. Several pathophysiological theories involving the central nervous     system have been proposed: the AIS would be associated with disturbances of proprioceptive or     sensory perception, and/or with integration of this information. This would result in an     abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the     deformation.      The Main aim of this study is to find cortical and subcortical morphometric differences in     the most common population of AIS (right thoracic AIS) compared to healthy adolescent control     girls.      Secondary Objectives are to study the cerebral white matter of the same groups (fractional     anisotropy in the main white matter tracts), and activation of sensorimotor neural networks     (fMRI activation and functional brain connectivity).      Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and     classification.   "
75120|NCT02302521|"     The purpose of this study is to evaluate our recently developed MRI reconstruction strategy     for producing artifact-free neuro and abdominal MRI data. The new reconstruction strategies,     including 1) REKAM and 2) MUSE, are capable of effectively removing motion-related artifacts     resulting from global and local motion during neuro and free-breathing abdominal MRI scans,     without modifying the MRI pulse sequences and protocols that are currently used in clinical     scans. The study team aims to recruit 60 subjects across multiple challenge patient     populations: 10 healthy young adults (age 20-30) and 10 healthy older adults (aged 50-70) for     abdominal MRI, as well as 20 tremor dominant PD patients and 20 children (age 4-8) for brain     MRI scans. There are no known risks in taking MRIs and a unique code will be assigned to each     participant to protect their PHI.   "
75121|NCT02302508|"     Clopidogrel efficacy appears diminished in patients with type 2 diabetes (T2D) who continue     to show an increased risk of adverse cardiovascular events and mortality compared to those     without T2D.The aim of the first project is to describe the pharmacokinetic (PK) profile of     three antiplatelet drugs in 4 groups of patients according to their diabetic or non-diabetic     status. To this end, PK profiles will be determined after a single oral dose of 300 mg     clopidogrel, 60 mg prasugrel and 180 mg ticagrelor in patients (n=108); 1) with T2D and good     glycemic control; 2) with T2D and poor glycemic control; 3) with insulin-treated diabetes;     and 4) non-diabetic subjects.   "
75122|NCT02302495|"     IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with     multiple myeloma at diagnosis. Study primary objectives are in the first step to determine     Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting     toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good     Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in     combination with Melphalan Prednisone at the end of the 9 induction cycles.   "
75173|NCT02301832|"     This is a study intended to evaluate a non-invasive device that uses light to measure the     amount of oxygen in the muscles of injured and non-injured legs in specific situations. The     name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to     collect the information necessary to understand the use of the NIRS monitoring system to     diagnose and direct treatment decisions in case of complications sometimes experienced in     traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).   "
77786|NCT02267694|"     This research study is about adding Black Raspberry powder to the treatment regimen of     patients with ulcerative colitis who are currently in remission and doing well.   "
75128|NCT02302417|"     The primary objective of the study is to identify demographic and non-spirometric clinical     features predictive of the asthma-COPD overlap population. The study aims to explore and     identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical     profile that enable clinical differentiation from subjects with a primary diagnosis of either     asthma alone (without persistent obstruction) or COPD alone (without reversibility). The     study is designed as a targeted medical history survey which consists of a 41-item     questionnaire, which will be administered by a qualified health care practitioner at the time     a subject's medical history is taken. The questionnaire has been developed to elicit specific     details of the respiratory history, including the following: bronchodilator use, disease     progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of     disease, symptom presentation, co morbidities and age of onset. In addition, demographic     information, standard medical history, co morbidity and spirometric results will also be     obtained and analyzed in conjunction with the questionnaire results. Approximately 1000     subjects are required for the study.   "
75129|NCT02302404|"     This study is the first administration of GSK2982772 in humans. The study will evaluate the     safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of single     and repeat oral doses of up to 14 days with GSK2982772 in healthy male subjects.      This study is planned to include approximately 52 subjects and will consist of 2 parts: Part     A - single ascending dose, randomized, placebo controlled, 4 way crossover. In addition to     the crossover treatment periods, up to 8 subjects in cohort 2 will participate in an     additional treatment period and receive GSK2982772 with a high-fat meal. Part B - repeat     dose, randomized, placebo controlled, sequential-group. In both cohorts of Part A (Cohorts 1     and 2), subjects will be randomized equally (1:1:1:1) to one of 4 treatment sequences. Within     each period, allocation of active to placebo treatment will be 3:1.      In all cohorts in Part B (Cohorts 3, 4 and 5) subjects will be randomized to GSK2982772 or     placebo in a 3:1 ratio. If required, subjects in the additional cohorts in Part A (Cohort 6)     and Part B (Cohort 7) will be randomized to GSK2982772 or placebo in a 1:1:1:1 and 3:1 ratio,     respectively. The study duration, including screening and follow-up, is not expected to     exceed 105 days for any subject in the study.   "
75130|NCT02302391|"     Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric     patients with long-term analgosedation will be performed. Especially, the chronologic     sequence of the quantified plasma levels during sedation and during wake-up as well as the     correlation to dose and sedation depth will be focused.   "
75131|NCT02302378|"     Spinal anesthesia is a common technique for providing anesthesia for knee joint replacement     surgery. The investigators wish to demonstrate that using a lower approach to spinal     anesthetic (Taylor's approach of L5-S1) causes less low blood pressure while still providing     adequate anesthesia for knee joint replacement surgery than a higher approach (L3-L4).   "
75132|NCT02302365|"     This study is a multicenter, retrospective data collection of routine clinical use with the     Spectra Optia® apheresis system for white blood cell depletion.   "
75133|NCT02302352|"     Systemic sclerosis (SSc) is an autoimmune disease with unknown etiology, which affects     especially the gastrointestinal tract, lungs, heart and kidneys. Immunological abnormalities     characterized by innate and acquired immune disturbances are associated with the disease     development. The present study aims to evaluate the efficacy and safety of probiotics in     gastrointestinal symptoms, nutritional status and innate and acquired immune responses, by     means of the evaluation of IgA, Treg and Th1, Th2, and Th17 T helper subtypes levels in     patients with SSc. In addition the levels of CD4+ T helper Th1, Th2 and Th17 subtypes and     Treg levels will be compared to a healthy control group.   "
75134|NCT02302339|"     This study will examine the effectiveness and safety of glembatumumab vedotin as monotherapy     or in combination with immunotherapies in patients with advanced melanoma.   "
75135|NCT02302326|"     The main objective of the present project is to evaluate the relevance of reticulum stress in     the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying     mechanisms of insulin resistance, which is the origin of metabolic comorbidities.     Furthermore, the investigators will assess the potential of insulin sensitizers as a     treatment to control endoplasmic reticulum stress markers in PCOS patients.   "
75136|NCT02302313|"     Healthy subjects should assess pain on a numerical scale (EN), during painful skin stimuli of     variable intensity delivered by a CO2 laser used at the power of 0.3 W, known for its safety.     ANI (Analgesia Nociception Index) will be raised simultaneously. This sequence will be made     on subjects at rest and in a state of hypnosis using the technique of remembering a pleasant     memory and the ideo-sensory technique of protective glove.      The average value of the ANI will be compared to the value of the EVN of pain intensity.   "
75137|NCT02302300|"     After cardiac surgery, many complications can arise, in particular at the cardiac and lung     level and it is true especially as the patient is with comorbidity. A patient will be     considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity,     Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation     (NIV)developed these last years in the treatment of acute cardiac insufficiency and the     hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and     abdominal surgery services.      Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a     decrease of ventilation work. According to these observations, the preventive NIV could     reduce the incidence of appearance of the lung and/or cardiac complications at the patients     to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect     to obtain a benefit with this particular population. If we meet our goal (a significant     difference in terms of morbi-mortality with the preventive NIV versus classical care), we     expect the systematisation of this procedure to all cardiac surgery high risk patients.   "
75206|NCT02301403|"     This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking     will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2)     Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment     have strong theoretical and empirical support from the investigators previous screening     studies.   "
75262|NCT02300662|"     A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate     the effects on critical patients on invasive mechanical ventilation of early mobilization     with a cycle ergometer.   "
75138|NCT02302287|"     Food intake has a deep influence on gut microbiota composition and function, both in health     and in disease status. In chronic kidney disease (CKD), a microbiota dysbiosis status is     observed. Moreover, many toxic uremic molecules are microbial-derived and their accumulation     promotes, in turn, disease progression.      Investigators' hypothesis foresees a beneficial effect of nutritional treatments, able to     restore gut microbiota balance, to lower microbial-derived uremic toxins and to improve     clinical conditions in CKD patients.      Mediterranean Diet (MD) is supposed to have beneficial effect on microbiota composition,     while low-protein diet supplemented with ketoacids (KD) is used in CKD patients for the     improvement of clinical conditions, but its effects on gut microbiota are currently unknown.     Investigators' project aim is to verify the effects of MD and KD on: microbiota and     metabolome composition, microbial-derived uremic toxins level and clinical conditions in a     cohort of CKD patients.   "
75139|NCT02302274|"     The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada     Syndrome cases. It proposes to assess the safety profile of this test in US patients and its     higher sensitivity when compared to procainamide infusion (the conventional drug used in the     USA). As a substudy it proposes to apply this test to early ARVC cases in order to evaluate     if ECG changes similar to those seen in Brugada Syndrome could be unmasked by flecainide iv.   "
75140|NCT02302261|"     Research has shown that pleth variability can be used to assess asthma severity in children     with status asthmaticus. The investigators would like to use an FDA-cleared monitor (Masimo     Radical 7) which measures Pleth Variability Index (PVI) to see if the degree of PVI can be     used to help triage patients who present to the pediatric ED in status asthmaticus.   "
75141|NCT02302248|"     This study evaluates a web-based, crowdsourcing platform to promote cognitive reappraisal.     Half of participants will be granted access to the crowdsourced reappraisal platform. The     other half will be provided a web-based expressive writing platform. The investigators     hypothesize that the crowdsourcing reappraisal platform will be more effective than the     expressive writing platform in promoting positive psychological outcomes.   "
75142|NCT02302235|"     The goal of the present study is to evaluate efficacy, safety and tolerability of 4:1     ketogenic diet administered adjunctively to standard radiation and temozolomide chemotherapy     in patients with GBM in a prospective, randomized open label study.   "
75143|NCT02302222|"     The goal of this study is to evaluate the impact of Customizable in the management of     extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional     hernia repair and/or functional panniculectomy as compared to SOC dressing, and to     significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC     surgical incision dressing.   "
75144|NCT02302209|"     The purpose of the investigators proposed study is twofold: 1) To investigate the role of the     affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with     schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate     whether manipulation of this oxytocinergic system positively influences these family     interactions.   "
75145|NCT02302196|"     The purpose of the study is to evaluate the safety and efficacy of breast reconstruction     using Autologous Fat Grafting (AFG) for women post lumpectomy that have contour defects.      The study hypothesis is that AFG has emerged as a less invasive alternative to breast     reconstruction post mastectomy. AFG could be used to treat breast contour defects with much     less invasive outpatient surgery, using the patient's own cells and tissues, which overall     reduces risk.   "
75146|NCT02302183|"     The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver     automatically oxygen in infants and children admitted at hospital for hypoxemic acute     respiratory distress.      In healthy volunteers adults, FreeO2 system provided a better control of the oxygen     saturation in function of designed target, reducing the desaturation time and hyperoxia. Our     hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute     respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation,     a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the     number of intervention by nurses.   "
75147|NCT02302170|"     Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic bacterium that     persistently colonizes the human stomach; more than half the human population is infected     worldwide. H. pylori infection is a risk factor for the development of gastritis, peptic     ulcer, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer.      The phaseⅠand Ⅱclinical trial of oral recombinant Helicobacter pylori vaccine had completed     in Jiangsu Province in China. The data from phaseⅠand Ⅱclinical trial suggested that the oral     recombinant Helicobacter pylori vaccine had a clinically acceptable safety and good     immunogenicity for health adults and children. To further explore the safety and     immunogenicity profile of this vaccine, a phase Ⅲ clinical trial was conducted.   "
75148|NCT02302157|"     The purpose of this study is to evaluate the safety of cross sequential escalating doses of     AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post     injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).   "
75149|NCT02302144|"     The primary objective of this study is to investigate the effects of a theoretically driven,     highly challenging exercise program (balance and strengthening exercises) in reducing fall     rate, improving balance and reducing fear of falling in persons with Parkinson's disease.      In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be     randomly assigned to either an early start (immediately following enrollment) or late start     (3 months after enrollment) multifactorial exercise program which will meet 2 times per week     for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening     exercises which will be individualized depending on the ability of each participant. Fall     rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be     measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be     enrolled for 6-7 months.   "
75150|NCT02302131|"     Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.      The aim of the registry is to document the feasibility and safety of implanting an Edwards     SAPIEN XT transcatheter heart valve in the pulmonic position.   "
75151|NCT02302118|"     Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus     extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II)   "
75152|NCT02302105|"     Evidence to justify the use of the pelvic field is lacking for men with high risk localized     prostate cancer. An additional randomized study is needed in men with a potential risk of     nodal involvement to test the hypothesis that the use of the pelvic field contributed to the     benefit observed in those studies.      This trial aims to compare the outcomes with whole pelvis RT and Prostate alone RT in     patients with High risk, non metastatic Prostate cancer with a Lymph nodal >20% with Primary     4 year Biochemical failure free survival and Secondary Disease free survival, overall     survival, Acute toxicity, Late toxicity and QOL Patients will be randomized to one of two     arms Arm 1 Whole pelvis radiotherapy and Arm 2 Prostate only radiotherapy. The Dose     prescription will be 66 Gy in 25 fractions will be prescribed for the prostate PTV in Arm 2     an additional 50 Gy in 25 fractions for nodal PTV in patients in Arm 1. An overlap volume at     rectal-prostate interface will receive 64 Gy/25#.      All patients will receive hormone therapy starting at least 8 weeks prior to the beginning of     radiotherapy. They will continue the hormone therapy and later for a total duration of 2-3     years.   "
75153|NCT02302092|"     The purpose of this study is to determine if the antibiotic Flomoxef performs as well as     Cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.   "
75154|NCT02302079|"     The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with     diabetic macular edema (DME). This study will evaluate the percent change from baseline in     excess central subfield thickness (CST) in the study eye as assessed by spectral     domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.   "
75155|NCT02302066|"     The purpose of this study is to assess the humoral immune responses to Takeda's Tetravalent     Dengue Vaccine Candidate (TDV) administered subcutaneously in a subset of healthy     participants between 2 and <18 years of age living in dengue endemic countries.   "
75156|NCT02302053|"     The New Viviscal Professional Strength is an oral food supplement specifically designed to     promote hair growth for women suffering from temporary thinning hair. It does not contain     hormones, drugs or industry by-products. Viviscal has been marketed in Europe for over 15     years.      The purpose of this clinical research study is to evaluate certain physiological effects of     Viviscal compared to placebo in forty (40) female subjects, ages 21-75 years of age with     self-perceived thinning hair associated with poor diet, stress, hormonal influences or     abnormal menstrual cycles when compared to using the placebo tablet.   "
75157|NCT02302040|"     The aims of this application are to develop and test AIM2ACT, a mobile health (mHealth) tool,     delivered via smartphones, that fosters helpful caregiver support as early adolescents (ages     12-15) with persistent asthma develop and master asthma self-management behaviors. To     facilitate helpful caregiver support, AIM2ACT uses mHealth technology to determine tailored     intervention targets for each family. AIM2ACT then helps caregiver/adolescent dyads set     asthma management goals by automatically guiding families through a structured process that     includes the supportive behavioral management strategies of goal setting, contingency     management, and problem solving communication. Skills-training videos for adolescents and     caregivers provide guidance on how to complete each collaborative asthma management     component.      AIM2ACT will be developed through feedback from an advisory board of adolescent-caregiver     dyads from the target user population and a pediatric pulmonologist. Following advisory board     feedback, the investigators will conduct a pilot randomized controlled trial of AIM2ACT with     50 early adolescents with poorly controlled asthma, ages 12-15 years, and a caregiver.     Families will be randomly assigned to receive AIM2ACT or a self-guided condition for a 4     month intervention period. Participants in the self-guided condition will be given general     information on supportive behavioral management techniques they can use to target improvement     in asthma self-management behaviors. Outcomes include whether participants prefer AIM2ACT or     the self-guided condition. Additionally, AIM2ACT and the self-guided condition will be     compared to see if there are differences in changes in family asthma management (primary     outcome), lung function, asthma control, asthma-related quality of life, and self-efficacy     for asthma management. Data will be collected before participants are assigned to AIM2ACT or     the self-guided control, post-treatment, and 4 month follow-up time points.   "
75158|NCT02302027|"     Chronic headache is most often associated with drug abuse and medication overuse headache     (MOH) is the main complication of migraine disease results in chronic daily headache. The     first phase of treatment consists of drug withdrawal .      The second phase of treatment (called consolidation) is to maintain the balance: treating     headaches and reducing / stopping the drug use.      The aim of this study is        1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy          (NOT) delivery by high flow concentrator        2. use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through          withdrawal period.      It is a feasibility pilot study in chronic headache with or without medication-overuse. All     patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and     used to be called traditional management. The subsequent attacks will be treated with NOT     from a high-flow concentrator      Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of     patients who accepted NOT during the withdrawal phase then to treat attacks.      Secondary endpoints. Efficacy will be assessed by the percentage of patients having no     chronic headaches two months after the start of withdrawal (less than 15 days of headache per     month) and no longer in drug abuse (less than 10 days per month with drug intake).      Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months      Effective : 30 patients   "
75159|NCT02302014|"     Patients admitted as an unscheduled hospital admission with either a acute heart failure     syndrome (ACF) or acute coronary syndrome (ACS) will be eligible if their 6-12 month     mortality risk is estimated to be 20% or greater at the time of discharge. Mortality risk is     estimated using GRACE (for ACS) or EFFECT (for AHF) scores. Patients are randomly allocated     to receive a holistic care intervention based around the creation of a detailed Future     (anticipatory) Care Plan which is agreed with the patient and their family and which is     shared with the Family Doctor and Emergency Services including ambulance teams. Primary     endpoint is quality of life assessed by questionnaire.   "
75160|NCT02302001|"     ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study     is designed to differentiate parameters of pain between randomized laterality using no touch     technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery     but will receive a refund of a partial payment. Patients must undergo evaluation at     consultation and surgical quote is provided.   "
75161|NCT02301988|"     This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II     study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy     versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa     triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.   "
75299|NCT02300181|"     The purpose of the present study is to evaluate the effect of the extract of the flour     fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects     with prediabetes.   "
75162|NCT02301975|"     This study is a randomized, double-blind, double-dummy, parallel group, multicenter,     non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are     currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist     (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice     daily [BD]), either via a fixed dose combination product or through separate inhalers. The     study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by     a treatment period of 24 weeks, and a follow up contact period of one week. The total     duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of     the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI)     100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via     ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD     (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via     ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol     inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine     if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via     ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately     controlled on a twice-daily ICS/LABA.      SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group     of Companies.   "
75163|NCT02301962|"     This is an open label, multicenter, non-comparative, phase IV study of panitumumab     monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral     oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene     homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the     requirement of the Indian regulatory authority to characterize the safety and tolerability of     panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS     metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated     wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to     achieve the target enrollment of 50 evaluable subjects who have received at least one dose of     panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously     every 14 days until disease progression, intolerability, withdrawal of consent, or death. All     subjects will be followed at 4 weeks and 8 weeks after the last administration of     panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of     the subject.   "
75164|NCT02301949|"     Background: Repeated episodes of bleeding from gastrointestinal vascular malformations     refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.      Methods: The investigators will perform a randomized, double blind, placebo controlled study     of thalidomide as a retreatment therapy for recurrent gastrointestinal bleeding due to     vascular malformation. Patients with failure of first course treatment of thalidomide will be     randomly grouped, prescribed a second four-month course regimen of 25 mg of thalidomide or     placebo orally four times daily. All patients will be monitored for at least one year. The     primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50%     at 12 months and the cessation of bleeding. Rebleeding is defined based on a positive fecal     occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after     treatment. Secondary outcomes include the participants dependent on blood transfusions and     changes from baseline in transfused packed red cell units, bleeding episodes, and hemoglobin     levels at 12 months. Statistical significance is defined at P < 0.05.   "
75165|NCT02301936|"     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and     tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for     12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle     cell disease (SCD).   "
75166|NCT02301923|"     This study aims to determine the average compliance of a patient under CPAP therapy for     obstructive sleep apnea as well as the various factors that influence it.   "
75167|NCT02301910|"     The aim of the study is to determine if single-bolus recombinant nonimmunogenic     staphylokinase is effective and save thrombolytic agent in patients presenting ST-segment     elevation myocardial infarction in comparison to tenecteplase.   "
75168|NCT02301897|"     The primary objective of this study is to determine the safety and efficacy of two oral doses     of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by     an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.   "
75169|NCT02301884|"     The investigators performed open-labeled pilot study which evaluates the efficacy and safety     of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including     Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are     sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.   "
75170|NCT02301871|"     A long term habitual posture with abnormal loading of ligaments and muscles, leads to     development of neck pain. 33 patients including 18 males and 15 females were selected and     randomly allocated into three groups using sealed opaque envelope containing treatment     allocation. Group A (n=11) received conventional treatment such as MHP (Moist Heat Pack),     Static Stretching exercises, Cervical spine non-thrust mobilization, Cervical spine active     ROM (Range of Motion) exercises and Postural exercises. Group B (n=11) received DNF training     with conventional treatment. Group C (n=11) received Muscle Energy Technique (MET) in     additional to conventional treatment. Primary outcome measure functional disabilities and     secondary measure pain and ROM were recorded at baseline, 7th day and 14th day.One-way ANOVA     was used for within group analysis. Repeated measure ANOVA followed by post hoc analysis was     employed for between group comparisons. The results suggest that there was a significant     improvement in mean change scores of Neck Disability Index (NDI), Visual Analogue Scale (VAS)     and Range of Motion (ROM) .Both DNF training and MET have additional therapeutic effects over     a standard care by reducing functional disabilities, pain and in improving ROM in mechanical     neck pain patients.   "
75171|NCT02301858|"     The project aims to compare the histopathological and molecular characteristics of tumour     tissue from metastases with similar analyses of the primary tumour in the lung, where it is     available.      The investigators will therefore perform analysis of blood samples if possible, to identify     predictive markers in blood samples.   "
75172|NCT02301845|"     This is an interventional crossover study aimed at validating diatom shells as a marker for     cuff leak and microaspiration in mechanically ventilated, critically ill patients.   "
75176|NCT02301793|"     As part of mandatory on-going nursing education, the investigators have incorporated     identical information into two distinct web-based learning formats - the traditional linear     PowerPoint format (with voice-over) and a new interactive format developed with central     nursing education.      The investigators will cluster randomize nurses by floor to receive either the traditional     education or the new interactive education, and evaluate the impact on administration of VTE     prophylaxis doses administered by nurses before and after education. All nurses on a floor     will receive the same educational format. If one method of education results in statistically     significant improvement in VTE prophylaxis administration, the investigators will cross over     to deliver the superior education format to all nurses who originally were given the less     effective method.   "
75177|NCT02301780|"     Phase III two arm double-blinded randomised controlled trial to examine the effect of     prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased     risk for PET on the incidence and severity of the disease   "
75178|NCT02301767|"     The purpose of the study is to view what normal breast tissue looks like on an MRI and     mammogram to help determine how it may affect the risk of developing breast cancer. The     investigators will also compare the information collected from the questionnaire and medical     records to help better understand how this may affect the risk of developing breast cancer.     If a saliva or tissue sample is collected for future use, this information will enable us to     study genetic risk factors as well.   "
75179|NCT02301754|"     INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors     unresponsive to currently available therapies, or for whom no standard therapy is available.   "
75180|NCT02301741|"     A fundamental clinical problem in individuals with chronic low back pain is the significant     alteration in movement patterns that restrict lumbar spine motion. This is particularly true     for individuals with fear of re-injury with movement (i.e., kinesiophobia). The primary aims     of the current study are to use a whole body video game environment to 1) determine the     effects of game play on lumbar spine flexion and expectations of pain and harm and 2)     determine the effects of altered movement gain on lumbar spine flexion.   "
75181|NCT02301728|"     The purpose of this study is to determine whether the acetate, butyrate and propionate     concentration in breast milk and to evaluate the possible correlation of these concentrations     with maternal diet.   "
75182|NCT02301715|"     The purpose of this study is to determine the effect of intranasal administration of OT on     behavior and discourse of insecure adolescents during a disagreement (stressful situation)     with parents.   "
75183|NCT02301702|"     Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis     vaccine (Tdap) is a potential strategy to protect young infants against pertussis before they     are fully vaccinated because maternal antibodies may cross the placenta and passively protect     her infant. The proposed study is a randomized, blinded, controlled, vaccine trial of     maternal Tdap vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36     weeks gestation). Pregnant women will be recruited from the prenatal care clinics at the     Hospital Nacional Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan     Ostuncalco and Concepción Chiquirichapa. Enrolled women and their infants will be followed up     until 7 months post-partum.   "
75184|NCT02301689|"     The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The     study aims to understand the importance of diagnosis and treatment of sleep disordered     breathing (SDB) on HF with the following questions:      How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does     SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment     adherence of patients treated? Does SBD and its treatment affect the survival of heart     failure patients?   "
75185|NCT02301676|"     The purposes of this study are to determine whether long-term postoperative cognitive     dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on     the result about POCD.   "
75186|NCT02301663|"     Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in     heart) with symptoms of persistent chest pain, primarily impacts women. There are an     estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent     data from our research group suggests that coronary microvascular disease impairs the way the     heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to     better understand the pathophysiology of the disease. The investigators will recruit 30     volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and     10 age-match women for the group with microvascular disease). Subjects will undergo a series     of stress maneuvers in conjunction with advanced cardiac magnetic resonance imaging.   "
75223|NCT02301182|"     A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the     Functional Results after Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in     Primary THA. 60 patients will be enrolled during a 2 year period. At surgery tantalum beads     will be inserted into predrilled holes of the polyethylene rim for assessment of motion of     the large mobile poly in the ADM Trident Cup by use of RSA. Patients will be followed by     functional examinations as well as PROM assessment.   "
75208|NCT02301377|"     The investigators know that adherence to medications in children with cystic fibrosis (CF) is     poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients and     their parents. Many of the investigators patients also report being motivated by the results     of their lung function studies (PFTs) to stay adherent to their medications. In this study,     the investigators would like to see if providing medication reminders and allowing patients     to measure their lung function at home will lead to better adherence. This will be a pilot     study to determine the feasibility of providing such as a device to children with CF.   "
75209|NCT02301364|"     The purpose of this study is to find out what effects, good and/or bad, Buparlisib (also     known as BKM120) has on lymphoma and the central nervous system.   "
75210|NCT02301351|"     The purpose of this study is to examine the effect of changes in cigarette package color and     warning label features on smoking behaviors and beliefs about cigarette risks.   "
75481|NCT02297815|"     The purpose of this study is to identify and use patient centered outcomes to compare rates     of treatment failure and the rate of adverse drug effects between narrow-spectrum and     broad-spectrum antibiotics for the treatment of common acute respiratory tract infections     (ARTIs) in children.   "
75187|NCT02301650|"     Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV)     transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT. Many     literatures demonstrate that using nucleoside (acid) analogs in late pregnancy can     significantly reduce HBV DNA level and effectively blocking MTCT. Therefore, treatment     guidelines of hepatitis B in Europe and the Asia Pacific region clearly pointed out:     Nucleoside (acid) analogs can be used in pregnant women after 28 weeks of gestation for     blocking MTCT in mothers with high HBV DNA level. At present, the drugs used in late     pregnancy including lamivudine (LAM) ,telbivudine(LdT) and tenofovir(TDF).      The safety of nucleoside (acid) analogues used in late pregnancy on children is not clear.In     most of the related researches,the observation termination was 7-12 months after birth, and     most were concentrated on the blocking effect of MTCT.The long-term impact of Nucleoside     (acid) analogues on children's development has not been reported in the literatures. The aim     of this study is to make clear of the effect of nucleoside (acid) analogues used in late     pregnancy on long-term impact of children's development.      The one year old children born in Beijing Ditan hospital and whose mothers had taken LAM,LdT     or TDF during late pregnancy will be enrolled as study group, and eligible children whose     mothers untreated will be enrolled as control group. The children's height, weight,     nutritional status, developmental quotient and immune response to hepatitis B vaccine etc     will be evaluated at baseline and at 3 years old. By comparing the children's development in     different groups as well as in self-control of different ages, we will discuss the effect of     Nucleoside (acid) analogues on children's long-term development.   "
75188|NCT02301637|"     The purpose of this clinical trial is to collect imaging data on embryos followed to     blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.   "
75189|NCT02301624|"     To evaluate the safety and efficacy of eculizumab in the treatment of refractory gMG as an     extension trial for the subjects who have participated in the ECU-MG-301 trial.   "
75190|NCT02301611|"     The majority of melanoma vaccines tested to date have been antigen-specific vaccines     targeting melanoma-specific or associated antigens and utilizing a variety of delivery     systems and immune-adjuvants. As opposed to testing an off the shelf vaccine that might be     able to treat a subset of patients, our approach has been personalized to the patient and     applicable to all patients. Our vaccine approach consists of harnessing the most potent     antigen presenting cell in the body - the dendritic cell (DC) - together with the full     repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II     studies using an autologous DC-tumor cell fusion technique that has now been simplified into     a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell     wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC.     These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID)     monthly x 3 followed by boosters at 6, 12, and 18 months.   "
75191|NCT02301598|"     The purpose of the study is evaluating safety and clinical efficiency of full femtosecond     laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus     and corneal opacities   "
75192|NCT02301585|"     A randomized controlled clinical trial to evaluate whether a passive leg raising test to     guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain.     Patients will be treated according to an algorithm in which the indexed stroke volume (stroke     volume related to body surface area) and mean arterial pressure will guide the timing and     amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized     to either an intervention group in which a passive leg raising test will be made prior to any     decision for fluid administration or to a control group where this test is not performed and     fluid administration is carried out according to standard of care at the department.      Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.   "
75193|NCT02301572|"     Chart review.   "
75194|NCT02301559|"     Primary dysmenorrhea is the result of hypercontractility and uterine vascular ischemia is the     most common gynecologic complaints in young women. According to the intensity of symptoms may     impair daily living, work and leisure activities. Pilates brings the concept of moving the     body for the recovery, maintenance and promotion of health through exercises that stimulate     circulation, improving physical conditioning, flexibility and proper postural alignment, and     promote improvement in the levels of body awareness, coordination and muscle control. In this     sense, the objective is to investigate the effects of pilates in the symptomatology of     primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from     the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical     picture. A questionnaire will be used for research. The students with the framework of     dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters,     pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of     life before and after the treatment protocol using the pilates method, often 3 weekly     meetings, totaling 20 sessions.   "
75195|NCT02301546|"     The current study will test the effectiveness of a computerized cognitive (thinking) training     program on improving thinking and memory in patients with mild cognitive impairment. The     investigators will also examine how short term changes in thinking abilities (i.e., practice     effects) can be related to improvement in thinking abilities after the cognitive training     program.   "
75207|NCT02301390|"     This study to is being conducted in India to determine the role of catheter-based ablation     for ventricular tachycardia (VT) in post- heart attack patients who meet established     guidelines for implantable cardiodefibrillator (ICD) implantation, but cannot afford it.     These patients would be started on chronic Amiodarone therapy, which has been shown to be     effective but can often lead to multiple side effects.      Patients will therefore be randomized in an even proportion to either a) the control group,     receiving chronic Amiodarone therapy, or the study group, undergoing catheter ablation of VT     in addition to chronic Amiodarone therapy.      This trial will serve as a representative model for the developing world.   "
75224|NCT02301169|"     The purpose of this clinical trial conducted in patients suffering from chronic pain is to     study the relationship between individual patients' profile and their analgesic response.   "
75300|NCT02300168|"     The aim of the current observational study is to better assess the relationships between     neuromuscular blockade and multiple surgical outcomes in patients undergoing elective     laparoscopic bariatric surgery.   "
75196|NCT02301533|"     Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection,     and prevent HIV transmission by making people less infectious. Men who have sex with men     (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can make     ART adherence difficult. Our goal is to find out if an intervention involving provider     counselling and support from an MSM peer will improve ART adherence and engagement in care     among Kenyan MSM. This study will be carried out in the KEMRI clinic in Mtwapa with 70 MSM     patient participants who reside in this area, identified through our outreach and testing     programs in Mtwapa. Six providers and five peers who are trained for the intervention will     also be consented in order to collect data on their feedback and help monitor the study. Our     intervention consists of support from a trained peer with experience taking ART and enhanced     counselling from providers that is aimed to motivate patients to improve and maintain their     health. In an initial pilot test, we will implement our intervention with 10 MSM starting ART     for the first time. After any needed revisions to research procedures and training, we will     next conduct a small randomized controlled trial with 60 MSM patient participants to     determine feasibility, acceptability, tolerability, and safety, and estimate an initial     effect size for the adherence intervention. The 60 patient participants will be randomized to     our intervention or to standard counselling care, and will be followed for 6 months to     evaluate their ART adherence and retention in care. Providers and peers will give feedback at     regular project meetings and in in-depth interviews after the pilot test and after the RCT.     The work proposed for this project will be carried out over 2 years, from June 1, 2014     through May 31, 2016.   "
75197|NCT02301520|"     Vitamin D deficiency is common worldwide, including in infants and children, and rickets     remains a public health concern in many developing countries. The vitamin D status and     prevalence of vitamin D deficiency in the Haitian population has not been studied. There is     currently no approved point-of-care testing device for vitamin D deficiency. Iodine     deficiency and resulting hypothyroidism is the leading cause of preventable     neuro-developmental delay and cognitive impairment worldwide. Young infants and children are     especially susceptible to sequelae of disruption in thyroid function given the dependence of     the developing brain on sufficient levels of thyroid hormone. Perchlorate and thiocyanate     have been described as potential environmental disrupters of thyroid function. Lead     intoxication is a significant cause of disease throughout the world. Millions of people have     suffered the effects of lead poisoning. Although most developed countries have taken drastic     measures to limit the environmental lead levels, many countries in the developing world have     not been able to address, or even assess, the problem.      Our objectives are to study the following three components in 300 Haitian children between 9     months and 6 years of age in three different geographical areas of Haiti: 1) Vitamin D status     and prevalence of rickets, environmental factors associated with low vitamin D levels, and     the accuracy and efficacy of a vitamin D point-of-care testing (POCT) device for the     screening of vitamin D insufficiency. 2) Iodine status and thyroid function, and     environmental disruptors such as perchlorate and thiocyanate as potential risk factors for     abnormal thyroid function. 3) Lead levels and the extent of childhood lead poisoning.   "
75198|NCT02301507|"     There has been increasing use of technology in delivery of healthcare and increasing use of     cellular phone and text messaging services to help with various healthcare related issues     including but not limited to medication adherence and clinic attendance. Mobile phones     technology has been used for healthcare delivery and prevention strategies such as smoking     cessation. In the present era, cell phones have become part of daily life for most people     even among those in lower economic groups. There have also been several studies looking at     cell phone text messaging services to improve adherence to ART among HIV infected subjects     but no studies have so far been done in HIV infected young women to help retention and     adherence to care. The overall goal of this study is to evaluation of the impact of texting     intervention to improve adherence to care and treatment in HIV infected young women.      Study Hypothesis:      Text message intervention will improve adherence to ART in HIV infected young women.   "
75199|NCT02301494|"     This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to     determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and     fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).   "
75200|NCT02301481|"     This prospective, randomized phase II study is designed to evaluate weather neoadjuvant     chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and     postoperative chemotherapy for locally advanced gastric adenocarcinoma.   "
75201|NCT02301468|"     A randomized controlled trial will be conducted to examine the effectiveness of DN versus IC     on trigger points in the neck and shoulder region for reducing pain and improving     functionality (primary outcome measures) and to investigate the effectiveness of DN versus IC     for muscle strength, mobility and muscle tone (secondary outcome measures).   "
75202|NCT02301455|"     One of the most powerful predictors of stroke is hypertension, with estimates of     approximately 33% of adults in the United States experiencing this condition.      Hypertension is very prevalent in the emergency department (ED), but significantly     undertreated. The overall goal of this project is to develop a text messaging intervention to     improve hypertension care in the ED. This will first be done by testing the feasibility of     identifying hypertensive patients in the ED, and the response rate to text messages.   "
75203|NCT02301442|"     Exercise has consistently yielded short-term, positive effects on health outcomes in people     with multiple sclerosis (MS). However, these effects have not been maintained in the     long-term. Behaviour change interventions aim to promote long-term positive lifestyle change.     This study, namely, Step it Up will compare the effectiveness of an exercise plus Social     Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control     education intervention on walking mobility among people with MS.   "
75204|NCT02301429|"     The purpose of this study is to evaluate the implant procedure and feasibility of a new lead     developed to pace and sense the left chambers of the heart.   "
75205|NCT02301416|"     This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese     individuals planning to undergo weight loss surgery. Individuals taking the medication before     and after surgery will be compared to historical controls who had surgery without taking the     medication.   "
75211|NCT02301338|"     The purpose of this study is to assess the impact of more frequent follow-up (by     videoconference) of these patients. Videoconference is a method of communication over a     distance. In this method, the patient will hear the person's voice (like on the telephone)     and will see that person over video.      The study will compare more frequent follow-up of patients by videoconferencing to routine     follow-up of patients. The investigators will compare each type of follow-up to see the     effect on the number of times patients need to visit emergency rooms or need admission to     hospitals. The study will also look at the difference between each type of follow-up on     patients' quality of life and social support thirty days after hospital discharge.      The study will also measure satisfaction and acceptability of this intervention among those     who had follow-ups by videoconference.   "
75212|NCT02301325|"     Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and     without transdermal nicotine on cigarettes smoked per day, nicotine exposure,     discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence,     biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use,     cigarette characteristics, cue reactivity, cardiovascular function, perceived risk and cue     reactivity. The investigators will also consider differences between conditions in compliance     with product use and the ability to abstain from smoking when provided a financial incentive     for abstinence.   "
75213|NCT02301312|"     This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a     vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be     enrolled and monitored at regular intervals for 18 months.   "
75214|NCT02301299|"     The investigators plan to develop and adapt a community-partnered intervention using     community health promoters (Stroke Promoters) to deliver messaging regarding stroke symptom     awareness and the need for calling 911 after stroke onset. The study investigators will     implement this intervention in 2 large south side Chicago communities and measure the impact     on symptom onset to hospital arrival times and EMS utilization using an interrupted     time-series analysis.   "
75215|NCT02301286|"     The purpose of this study is to determine whether acetylsalicylic acidis effective on the     recurrence and survival of colon cancer patients.   "
75216|NCT02301273|"     Patients who have been admitted to Intensive Care Units (ICU) and are intubated and     mechanically ventilated for longer than 48 hours have impaired physical, psychological and     social health and well-being six to twelve months after discharge. The advocacy of intensive     physiotherapy and mobilization early in the course of critical illness has been established.     It is of great importance to study the long-term outcomes (physical function and quality of     life) in intubated and ventilated patients who start exercising and ambulating mobilizing) as     soon as possible during ICU stay because the most effective mode, intensity or frequency of     exercise needs to be identified.      The aim is to study the short- and long-term outcomes of enhanced early physiotherapy and     upright position in critically ill patients on prolonged invasive ventilation and to develop     principles to guide physiotherapists in their clinical decision making in the ICU.   "
75217|NCT02301260|"     The purpose of this research study is to investigate the effectiveness of a computerized     technique designed to improve processing speed (i.e. the amount of time it takes for a     person's brain to process information) in a multiple sclerosis (MS) population. The study is     designed to study how well this technique can help people with MS increase their processing     speed and their ability to function better in everyday life. This treatment protocol has been     studied extensively with older adults, showing improvements on standard laboratory measures     of processing speed and performance of activities of daily living.   "
75218|NCT02301247|"     This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide     Class I evidence in support of or in refute of the efficacy of the modified Story Memory     Technique (mSMT) in persons with progressive MS, with outcome measured through three     mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global     functioning (AGF) examining the impact of the treatment on daily activities, and (3) an     optional functional magnetic resonance imaging (fMRI) scan.   "
75219|NCT02301234|"     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of     fulranumab as adjunctive therapy compared with placebo in participants with signs and     symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current     pain therapy.   "
75220|NCT02301221|"     The purpose of this study is to evaluate the effect of fecal microbiota transplantation in     adults with slow transit constipation.   "
75221|NCT02301208|"     This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin     concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).   "
75222|NCT02301195|"     This study is being carried out to learn more about the effects of Therapeutic Horseback     Riding (THR) for children and adolescents with an autism spectrum disorder (ASD). This     treatment is very popular and horseback riding for children and adults with disabilities has     been used as a form of therapy in the United States for over forty years. However, very     little research has been done to find out whether or not THR is effective as a therapy for     children with an ASD. This study is being done to see if THR will improve the agitation     behaviors, coordination, and communication skills of children and adolescents with an ASD.     This study is also being done to find out if the horse is necessary for children and     adolescents with an ASD to improve.   "
75226|NCT02301143|"     This clinical study is in subjects who are 18 years old or older with locally advanced     pancreatic cancer who have not received prior treatment for their pancreatic cancer. The     study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of     treatment. Subjects who complete the treatment will choose, with their treating physicians,     what additional treatment should be given: more nab-Paclitaxel plus gemcitabine,     Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.   "
75227|NCT02301130|"     Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with     Tremelimumab in Subjects with Advanced Solid Tumors   "
75228|NCT02301117|"     Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with     advanced solid tumors and varying degrees of renal impairment.   "
75229|NCT02301104|"     Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with     advanced solid tumors and varying degrees of hepatic impairment.   "
75231|NCT02301078|"     This study will evaluate short-term pain and function associated with percutaneous needle     aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in     patients with Dupuytren's disease. Scores on outcome measures will be compared between groups     to determine whether treatments differ in terms of hand function and pain during the early     post-treatment period.   "
75232|NCT02301065|"     Viral infections and reactivation during pediatric allogeneic hematopoietic stem cell     transplantation (HSCT) are a common occurrence and significantly contribute to     post-transplant morbidity and mortality. The risk is high due to prolonged periods of immune     deficiency while awaiting immune reconstitution post-transplant. Current strategies to reduce     complications from viral infections include prophylactic treatment, close monitoring for     viral infections and prompt treatment at the first sign of symptoms or increasing viral load.     However, the most definitive treatment for viral infections remains the host's cellular     defenses. Improved understanding of the immune systems response to viral infections may lead     to better treatment strategies.      This study is being done to explore the relationships between T-cells and NK cells (infection     fighting cells) and viral infections or reactivations in young allogeneic stem cell     transplant patients. The investigators will be looking at how these cells react and function     in young patients receiving allogeneic stem cell transplantation, as well as in healthy stem     cell donors.   "
75233|NCT02301052|"     Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in     management of symptomatic hemorrhoids in a double blind randomized placebo-control trial   "
75234|NCT02301039|"     The purpose of this study is to determine the efficacy of pembrolizumab in patients with     advanced sarcomas.   "
75235|NCT02301026|"     The purpose of the study is to monitor initiated Diafer® therapy administered according to     hospital practice and the product labeling in routine clinical practice in haemodialysis     patients with Chronic Kidney Disease.   "
75236|NCT02301013|"     Main objective is to evaluate the relation between the increased urethral mobility and     unsuccessful treatment after TVT and TOT operations.      140 patients will be included in the research who are planned to have TVT and TOT operations     with SUI and MUI diagnoses.Female patients of 25 to 70 years of age who are positive for     stress test will be included.      All patients will be questioned for parity, body mass index, menopausal state, medical     history, and examined for POP-Q stage, urodynamy, stress test, UDI 6, IIQ7 and with     transperineal sonography preoperatively. Passive mobility angle and active mobility angle     will be measured.      The relationship between passive mobility angle or active mobility angle and success of sling     operations will be determined in this study.   "
75237|NCT02301000|"     This is a randomized controlled trial to compare the effect of a 10-day course of per oral     Metronidazole versus a one-time rectal instillation of an anaerobically cultivated human     intestinal microbiota for the treatment of a first occurrence of clostridium difficile     infection (CDI). Recurrent CDI is common after standard antibiotic treatment. We hypothesize     that the instillation of a healthy intestinal microbiota will be more effective in inducing a     durable cure than Metronidazole for primary CDI.   "
75238|NCT02300987|"     To assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory     teratoma with recent progression   "
75239|NCT02300961|"     This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based     neurocognitive intervention program. It will secondarily be evaluated by performance on the     neurocognitive testing post-transplant and change in performance in subsequent years.   "
75240|NCT02300948|"     There are three objectives in this study:        1. To assess the serum folate pharmacokinetics of ingesting a single dose of          PregVit-Folic5® versus a single dose of PregVit® (a multivitamin containing 1.1 mg folic          acid)        2. To assess the steady-state red blood cell (RBC) and serum folate concentrations achieved          in non-pregnant, fertile women who supplement daily with PregVit-Folic5® versus PregVit®        3. To assess the steady-state RBC and serum folate concentrations achieved before and          during pregnancy in women planning a pregnancy or early in pregnancy (<6 weeks          gestation) who supplement daily with PregVit-Folic5® versus PregVit®.   "
75241|NCT02300935|"     This study will investigate the combination of two drugs, trametinib and nab-paclitaxel, in     patients with advanced unresectable or metastatic melanoma. Each drug has shown activity in     trials of patients with melanoma. However, the combination of these two drugs has not been     studied. In this trial the investigators will determine the maximum dose of the drug     combination to be administered to patients with advanced unresectable or metastatic melanoma     and examine the safety profile of the drug combination.   "
75242|NCT02300922|"     Phase I/II, Open-labeled, Prospective, Multi-center study of a Pretargeted Radioimmunotherapy     in metastatic colorectal cancer with ractionated injections of TF2 plus 90Y-IMP288     (RITCOLON).   "
75243|NCT02300909|"     Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar     laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.   "
75244|NCT02300896|"     The current model of care for the hospitalized elderly patients has been conditioned by many     factors unrelated to the disease process that caused the hospitalization and usually worsen     the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend     most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are     walking). These patients have their functional and physiological reserve reduced which makes     them more vulnerable to the effects of being bedridden. The consequences are at multiple     levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and     institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake,     social isolation, poor quality of life and increased use of resources related to health.     Exercise training can prevent functional and cognitive decline and modify even the posterior     trajectory.   "
75245|NCT02300883|"     This is an observational prospective analysis of biological characteristics of malignant     mesothelioma (MM) patients. Frozen and paraffin-embedded tumor specimens and pleural effusion     of patients will be collected and than will be analyzed with the following analyses:      1Purification of Tumour Associated Macrophages (TAM) and tumour cells from pleural effusions.      2.Mass spectrometry analysis of TAMs and tumor cells 3.Co focal microscopy analysis of     macrophages, tumour cells and specimens derived from patients.   "
75249|NCT02300831|"     The recent development of therapies targeting specific biomarkers mutations is changing the     standards of care and prognosis of patients with advanced NSCLC, but very few data are     currently available on those emerging biomarkers. In addition, the correlation of biomarkers     with patients' clinical outcomes in a standard of care setting is poorly understood. This     study aims to address that need.   "
75250|NCT02300818|"     Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular     pressure (IOP) has been identified as the most important risk factor. However, some patients     progress despite adequate IOP lowering while some subjects with elevated IOP never develop     glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal     range. Therefore, other factors must be involved. In the last years, studies using MRI have     been performed and evidence has accumulated that also changes in retrobulbar structures are     present, in particular in the lateral geniculate nucleus and the visual cortex. However,     these studies were limited by the low spatial resolution of the MRI instruments used.   "
75251|NCT02300805|"     Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office     hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women     complaining of abnormal uterine bleeding.      The safety of both procedures will be compared .   "
75252|NCT02300792|"     This study is a randomized, placebo controlled, double-blinded clinical trial, which included     50 children with hepatitis A. They were of both sexes and their age ranged from 2 to 18     years. The patients were randomly assigned into one of two groups; each consisted of 25     children. Each patient in the intervention group (group 1) took oral honey in a dose of 5     ml/kg/day (with a maximum dose of 150 ml/day) for four weeks, whereas patients of the placebo     group (group 2) took placebo in the form of molasses. The main outcome measure was the     recovery time defined as the number of days from the start of the intervention to subsidence     of symptoms and signs of hepatitis and return of liver transaminases to their normal levels.   "
75253|NCT02300779|"     This trial will compare the efficacy of to 2 different sets of dietary recommendations to be     followed before colon cleansing for colonoscopy in diabetic patients.   "
75254|NCT02300766|"     The purpose of this study is to determine why up to 25% of the pediatric patients who have     surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS).     Furthermore the purpose is to explore the clinical course and the best treatment of the     syndrome.   "
75255|NCT02300753|"     Expanded access Protocol to treat LHON subjects with EPI743   "
75256|NCT02300740|"     Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so     far not analyzed.   "
75257|NCT02300727|"     Oral mucositis is a common side effect from cancer treatment. Patients receiving chemotherapy     and radiotherapy can get very painful sores in their mouth that compromise nutrition and oral     hygiene as well as increase risk for infection, and can last for weeks. Currently, the only     treatment for mucositis is oral hygiene to try to support recovery.      Curcumin (also known as Turmeric) is a frequently-used spice in India and Southeast Asia.     Studies in cells and animals have shown that it can reduce the amount of bacteria and can     prevent inflammation.      In this study, the investigators want to learn if a mouthwash made with curcumin is safe for     people to use and if it can help their mucositis.   "
75258|NCT02300714|"     A comparison of anterioposterior versus oblique view approach method for     fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate     differences on total radiation time and technical feasibility between anterioposterior and     oblique view approach method.   "
75259|NCT02300701|"     To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.   "
75260|NCT02300688|"     After administration of besifovir preparations different from each other to healthy subjects,     the investigators evaluate equivalence of bioavailability of LB80331.   "
75261|NCT02300675|"     The purpose of this study is to evaluate the feasibility and the effectiveness of a patient     education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or     aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient     education and medical oncologists.   "
75263|NCT02300649|"     Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an     adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular     effect through activation of receptors in central and peripheral nervous system. The classic     cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase     in blood pressure followed by long-lasting decrease in BP and HR. There were several reports     about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects     on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine     as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.   "
75264|NCT02300636|"     This study investigates different resistive co-contraction trainings effect on knee strength     recovery after ACL reconstruction. Participants will be divided into three groups. Group 1     will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic     chain position, Group 2 will receive standard ACL rehabilitation with 8 week co-contraction     training in open kinetic chain position and Group 3 (control group) will only receive     standard ACL rehabilitation.   "
75265|NCT02300623|"     Interventions during primary HIV infection (PHI) can modify the immune control and the     clinical evolution during the chronic phase. Although several studies suggest the benefit of     antiretroviral treatment (ART) during PHI, indication of ART is still not universally     recommended. The investigators randomized patients with PHI, with a favourable immunological     profile and well controlled on ART, to undergone structured treatment interruptions alone or     with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV     replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and     clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up     to nine years since final ART stop.   "
75459|NCT02298101|"     Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer     specifically designed for spontaneously breathing patients. This device has not been     investigated in vivo yet.      It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized     that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to     a standard jet nebulizer.   "
75267|NCT02300597|"     Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered     internet-based support and coaching during eight weeks (chat and e-mail). Data is collected     before and after the intervention and six months after end of treatment using self-report     questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and     anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next     of kin. After treatment the young people are interviewed regarding the quality of the     intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is     offered treatment as usual and is assessed at the same time points as the intervention group.     The individuals are not randomized due to difficulties to recruit if the individuals do not     know group assignment in advance.   "
75268|NCT02300584|"     The purpose of this study is to refine and test the web-based delivery of a well-established     in-person group program that provides information and education to informal caregivers     (family and friends) of persons with Alzheimer's disease (or related illnesses).   "
75269|NCT02300571|"     This observational study is proposed to observe the effect of high-dose, post-transplantation     cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an HLA-identical or     mismatched donor.   "
75270|NCT02300558|"     This study will evaluate the effect of eleclazine on shortening of the corrected QT interval     (QTc), safety, and tolerability in adults with type 3 long QT syndrome (LQT3). During the     single-blind treatment period (24 weeks), participants will receive eleclazine and/or     eleclazine placebo. Following the single-blind treatment period, participants who have not     permanently discontinued study drug will be eligible, at the discretion of the investigator,     to continue receiving eleclazine during an open-label extension phase.   "
75272|NCT02300532|"     Post-marketing surveillance to investigate the clinical safety and effectiveness in patients     of all implantation of Gliadel with malignant glioma in the actual medical setting.   "
75273|NCT02300519|"     Personalized therapy in haemophilia has not been reached yet. Treatment is substitutive and     its doses are only based on the levels of deficient factor VIII (for haemophilia A) or IX     (for haemophilia B). The bleeding severity is not only related to the factor deficiency but     also to levels of other coagulation factors (e.g. factor X, II, AT or TFPI). It's necessary     to take them into account in order to individualize treatments; and Thrombin Generation Assay     (TGA) with the CAT method (Calibrated Automated Thrombography) is a good way because it     measures the result of the coagulation cascade. TGA on Platelet Rich Plasma (PRP) is even     closer to physiological conditions than on Platelet Poor Plasma (PPP) because platelet     influence is represented. It has already been shown (at least in PPP) that the bleeding     tendency in haemophilic patients is usually well correlated to TG. Some TG parameters are     used to characterize the individual coagulation phenotype, the most important being the     Endogenous Thrombin Potential (ETP) and the Lag Time (LT). A hemorrhagic profile usually     provides a longer lag time and / or a lower ETP. However, only few studies tried to determine     the influence of each coagulation factor and inhibitor on TG. They were done on Platelet Poor     Plasma (PPP) or on lyophilized plasma. So the relation between coagulation factors and the     different TG parameters remains to be determined, especially in the haemophilic case. It is     possible, experimentally, to find the optimal dose of the factor to be added by measuring TG     in samples with different factor VIII or IX concentrations, but this method would be time     consuming and expensive, especially because it should be done for each haemophilic patient. A     better way consists in using TG numerical models. For a set of initial factor levels they     simulate the TG and its associated parameters. It is now essential to validate the existing     models, especially in haemophilic cases, in order to see whether they are reliable and can be     used in clinical practice afterwards.The objective of this study is to validate thrombin     generation numerical models which could predict the factor VIII or IX activity correction to     reach a thrombin generation sufficient to avoid bleeding. A comparison between the TG     observed in haemophilic patients and the TG predicted by the models is needed to validate the     models. In order to define a 'safe' TG i.e. sufficient to avoid bleeding, normal ranges of TG     parameters have to be measured.   "
75274|NCT02300506|"     The objective of this study is to determine the survival status of patients enrolled in study     GLI01S (all-case observational study).   "
75275|NCT02300493|"     Examining the effect of daily self-weighing on the ability of student to prevent from gaining     weight during their four years at Cornell.   "
75276|NCT02300480|"     Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an     incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC     remains unknown and visceral hyperalgesia and central sensitization have been suggested to be     part of the pathophysiology. So the purpose of this study is to determine whether Calot's     Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is     superior to PCIA in reducing the incidence of chronic pain after LC.   "
75277|NCT02300467|"     The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety,     tolerability and pharmacokinetic profiles and to assess the efficacy of NOV120401 (CKD-516     Tablet), a novel vascular disrupting agent, in patients with advanced refractory solid     tumors.   "
75278|NCT02300454|"     Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent     restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation     impacts on clinical and angiographic outcomes or not is unknown. Lacrosse® Non-slip element     balloon (NSE) is a balloon catheter with 3 longitudinal plastic elements which are attached     to proximal and distal balloon edges. NSE is developed to incise neointimal tissue and avoid     balloon slippage without vitiating balloon derivability and crossability. We investigated     angiographic and clinical outcomes following normal non-compliant balloon or NSE dilatation     prior to DCB dilatation in ISR lesions.This study is a single blinded, multicenter,     randomized trial. Total 200 patients with ISR are randomly assigned to treat with     non-compliant balloon or NSE before DCB dilatation. Optical coherence tomographic (OCT)     analysis are performed before pre-dilatation and after DCB dilatation Follow-up angiography     analysis are planned at 8 months in all patients. Clinical follow-up is planned at 8 and 24     months.Primary endpoint is angiographic in-segment late loss at 8 months.   "
75279|NCT02300441|"     A prospective cohort pilot study of non-cardiac patients to determine the feasibility of     recruiting 150 patients to undergo postoperative continuous hemodynamic monitoring for up to     3 days.   "
75291|NCT02300285|"     Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in     infants with low blood glucose to improve how we care for these infants. To do this we plan     on monitoring blood glucose levels with CGMs (instead of only with intermittent     bloodsampling) in late-preterm and term infants admitted to the NICU who have had     hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us to     find a diagnosis and treat sooner, we will randomize patients into one of two groups: a CGM     group where the CGM information is made available to the NICU team and a Standard of Care     group where the CGM information will only be available to the research team. However, if     infants in the Standard of Care group are noted to have three unrecognized severe low blood     glucose levels then the research team will inform the NICU team that this has occurred.   "
75280|NCT02300428|"     Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with     children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million     prescriptions for oral iron are filled in England alone (NHS Information Centre data).     However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients     (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron     salts constitute the vast majority of currently prescribed oral iron because these are cheap     and well absorbed. However, they are also poorly tolerated and thus, we believe, are     expensive to the NHS.      Funded by the Medical Research Council, we have developed an alternative oral iron     supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy     for IDA with minimal side-effects.      In the study proposed here we aim to assess the total health cost associated with current     oral iron supplements and, hence, define the clinical unmet need for alternative treatments.     We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern     of prescribing to oral iron in primary care in the general population and (ii) develop a     health economics model in pre-menopausal women. These data will provide evidence for the     total health system costs associated with current oral iron treatment. Furthermore, this     study will provide data from which the cost-effectiveness and total health system costs of     alternative effective and treatments with minimal side-effects could be estimated.   "
75281|NCT02300415|"     Severe sepsis and sepsis shock are common in emergency department, with a high mortality     rate. The potential severity of this disease impose a diagnosis as early as possible to start     antibiotic therapy and hemodynamic support. Conventional biomarkers are an important support     for the emergency physician. However, comparison of sensitivity and specificity for new     biomarkers, like presepsine, suggests that they can be more efficient in this area.      In this single-center, prospective, non-interventional study, we propose to compare the     sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic     shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of     lactate for the diagnosis of severe sepsis.   "
75282|NCT02300402|"     The present study aims to further optimize a whole-body Diffusion‐Weighted Magnetic Resonance     Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and     Positron Emission Tomography (PET), to develop and validate an automated whole-body     parametric image analysis algorithm, and to determine the added value of whole-body DWI to     Fluorodeoxyglucose-PET for the management of lymphoma patients.   "
75283|NCT02300389|"     The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost     Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients     combined with Androgen Deprivation Therapy.   "
75284|NCT02300376|"     Diagnosis of patients with renal insufficiency and recommendations for medical treatment of     patients who suffer from chronic renal failure are based on the different stages of     Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas     are unreliable in many clinical situations (old people, obese patients…). Methods for     measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference     tracers. Renal clearance of Inulin is the gold standard. However, using these methods is     restricted to specialized services because it is long and expensive.      There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR.     Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a     tracer comes from its exclusive elimination by glomerular filtration.      Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every     included patient during a hospital day care (First visit V1). For transplanted patients,     plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less     48hours) during annual medical check-up of renal transplantation (Second visit V2).   "
75285|NCT02300363|"     This study will be conducted as a single-center, open-label, 2-period, single-sequence,     drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg     tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male     and female subjects.   "
75286|NCT02300350|"     This study will be conducted as a single-center, open-label, 2-period, single-sequence,     drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg     administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 ×     0.25-mg tablets) in healthy male and female subjects.   "
75287|NCT02300337|"     Optimization the cuff pressure of the laryngeal tube (LT) in relation of the mechanical     ventilation, and the reduction of potential leakage mucosal trauma. Comparison of the     tightness of LT between the filling volume specified by the manufacturer (connectors are     color coded syringe and blocker), 60cmH₂O, 50cmH₂O, 40cmH₂Ound 30cmH₂O. The measurement of     the leakage occurs in ml / kg body weight.   "
75288|NCT02300324|"     There is current evidence that suggests eating cruciferous vegetables like broccoli,     cauliflower, cabbage is beneficial to our health as they contain compounds which are thought     to reduce the risk of diseases such as cancer and cardiovascular diseases. Cruciferous     vegetables are able to deliver in our body a group of compounds called isothiocyanates (ITCs)     that are thought to be responsible of their health-promoting effects. Sulforaphane (SF) from     broccoli is one of the most studied ITCs and its anticancer properties have been extensively     investigated in in vitro and in vivo models.      The investigators propose to undertake an intervention study to measure the bioavailability     of SF from the soups used in another intervention study called ESCAPE. The investigators     would like to investigate the rate and extent to which SF reaches the systemic circulation     and is excreted in urine by measuring SF and its metabolites in plasma and urine samples     collected from apparently healthy participants after consumption of the three types of     broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and     two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver     different levels of SF.      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)     and Prostate Cancer foundation (PCF).   "
75289|NCT02300311|"     To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in     patients with acute low back pain. To investigate the safety and tolerability of repeated use     of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).   "
75460|NCT02298088|"     Administration of TicagRElor in pAtients with ST elevation myocardial infarction treated with     pharmacological Thrombolysis   "
75292|NCT02300272|"     This is a single-center, observational study design. Enrolled participants will be typically,     healthy older adults. Participants will complete daily computerized measures, in addition to     continuously wearing an Actiwatch device. The study period will last 2 weeks. The objectives     of the study are to examine the impact of sleep, pain, and circadian rhythm on     practice-related learning in older adults at their preferred versus nonpreferred times of     day.   "
75293|NCT02300259|"     The first purpose of this study is to evaluate the effect of itraconazole (and possibly     diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get     rid of it.      The second purpose of the study is to evaluate the effect of LY2623091 on the amount of     simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get     rid of it.      The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and     diltiazem or tadalafil will be evaluated.      There will be three groups of participants in this study. Results from Groups 1 and 2 will be     analyzed during the study to determine whether to enroll participants in Group 3 or 4. The     study is expected to last up to 40 days from the first dose to follow-up (inclusive).     Screening may occur up to 28 days prior to enrollment.   "
75294|NCT02300246|"     The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with     biomechanical processing simplified and without the need for handling blood biochemistry.     Some studies have shown the potential of PRF in release growth factors assisting and     accelerating the regeneration of soft tissues, however with contradictory results regarding     the hard tissues. The aim of this study will be to evaluate through clinical analyzes,     histomorphometric and micro-computed tomographic images, the dimensional changes, the     quantity and the quality of the tissues formed socket after extractions that receive     membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction and     the other 15 (control group) received no biomaterial (spontaneous healing).   "
75295|NCT02300233|"     The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26     weeks in patients with Hypertriglyceridemia   "
75296|NCT02300220|"     This study investigates the effects of targeted re-treatment of patients who do not recover     from an exacerbation of COPD. Half of the patients will receive ciprofloxacin while the other     half will receive a placebo.   "
75297|NCT02300207|"     To investigate the changes of cardiovascular function during short-term simulated     weightlessness after electroacupuncture (EA) treatment．   "
75298|NCT02300194|"     Introduction:      Opioids, such as morphine, act at receptors in the central nervous system, but many studies     have suggested direct action peripherally on opioid receptors in sensory neurons terminals,     melanocytes, keratinocytes and fibroblasts. These receptors are stimulated when occurs     inflammatory processes.      Hypothesis:      Treatment with topical morphine 0.1% applied 30 minutes before an invasive procedure,     decreases pain in children.      Method:      A randomised double-blind parallel study to evaluate the effect of topical application of a     0.1% morphine gel in patients undergo a procedure. 22 patients in each group will be     included. Randomly assigned to either the morphine gel or a placebo hydrogel, it will be     applied 30 minutes before the procedure and the first day every 4 hours. General basic     sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be     measured with Face, Legs, Activity, Cry, Consolability scale (FLACC scale).   "
75302|NCT02300142|"     This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be     randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.      Objectives:        -  To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6          different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:             -  Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last               dose of vaccine             -  Lesion rate (percent of days with genital lesions present) during the               post-vaccination follow-up period             -  Antiviral use.        -  To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.   "
75303|NCT02300129|"     Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of     the flush of rosacea.   "
75304|NCT02300116|"     The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor.   "
75305|NCT02300103|"     The primary objective of this study is to evaluate the efficacy, safety and tolerability of     treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks     in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead     sponsored study and did not achieve sustained virologic response (SVR).   "
75306|NCT02300090|"     A real world study to determine the effectiveness of a patient support service to aid COPD     patients in their self management.   "
75307|NCT02300077|"     The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain     therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by     providing more stable plasma concentrations and long-lasting pain relief. Methadone     perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients     is well characterized. There is, however, no information on methadone use in an ambulatory     surgery setting and outpatient procedures. This pilot investigation will determine     effectiveness of intraoperative methadone in reducing postoperative opioid consumption and     providing improved pain relief in patients undergoing moderately painful, ambulatory surgical     procedures.   "
75308|NCT02300064|"     The purpose of this study is to find out more about the effects of chronic obstructive     pulmonary disease (COPD) on the function of blood vessels, the heart, and muscle at rest and     during exercise.   "
75309|NCT02300051|"     The purpose of this study is compare three interventions (short-term psychodynamic     psychotherapeutic group and relapse prevention group therapy vs. treatment as usual, namely,     psychiatric follow up including prescription of medication vs. both interventions combined)     to individuals presenting compulsive sexual behavior.   "
75342|NCT02299622|"     The next generation of personalized medical treatment according to the type of personal     genetic information are evolving rapidly. The genome analysis needs systematic infra and     database based on personal genetic information Therefore, a big data of genome-clinical     information is important.   "
75310|NCT02300038|"     Background Subanesthetics concentrations of lidocaine are able to produce a differential     block of the ectopic discharges, but not propagation of impulses, suppressing differentially     the associated neuropathic pain symptoms. The aim of this study was to investigate the     differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine     0.1% on several neuroma related pain modalities.      Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury     participated in this randomized, double-blind experiment. The patterns of sensory changes     were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the     neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using     a visual analogue scale (VAS), quantitative and qualitative sensory testing.   "
75311|NCT02300025|"     This study is an open-label, multi-center, single-dose, parallel group study to determine the     pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted     male and female adult subjects with varying degrees of hepatic function. The study will be     conducted based on the Child-Pugh classification of hepatic impairment. The anticipated     duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying     degrees of hepatic function and up to 12 healthy control volunteers.   "
75312|NCT02300012|"     Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.      Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches     to patient treatment, and biochemical, biomechanical and physiological biomarkers in other     conditions are sensitive in distinguishing between disease state severities, type of injuries     and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not     widely used possibly owing to their focus postoperatively where benefits are less worthwhile.      This study aims to investigate novel biomarkers as performance based investigations (PBIs) to     improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The     objectives are to identify whether biomarkers, collected before and after operations, can: 1)     Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict     the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further     understand ACL injuries.   "
75313|NCT02299999|"     Open label multicentric phase II randomized trial, using high throughput genome analysis as a     therapeutic decision tool, which aims at comparing a targeted treatment administered     according to the identified molecular anomalies of the tumor with maintenance chemotherapy     (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients     without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).   "
75314|NCT02299986|"     'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by     Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical     ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and     colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a day     in a small cohort of mechanically ventilated patients. This is a longitudinal, single-centre,     observational cohort study to examine the long-term effects of invasive mechanical     ventilation on the diaphragm, and to study the risk factors associated with VIDD.   "
75379|NCT02299141|"     There has been limited benefit with angiogenesis inhibitor drugs when used with molecularly     selected patients in non-small cell lung cancer (NSCLC). The investigators propose that     patients who are molecularly selected for treatment with nintedanib based on the presence of     mutations (VEGFR1-3, PDGFR-A, PDGFR-B, and FGFR1-3) will have clinically meaningful benefits     in terms of response rate (RR) and progression-free survival (PFS). Furthermore the     investigators plan to perform exome sequencing of paired tumor (pre and post treatment) in     order to better define molecular marker predictors for response and resistance.   "
75315|NCT02299973|"     Intestinal microbiota dysbiosis is thought to play an important role in the complex     pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS     and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been     shown to be an effective means of correcting this imbalance in the gut microbiota, especially     in patients with recurrent Clostridium difficile infections where it has become a preferred     treatment strategy.      In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy     in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal     bloating was seen three months after transplantation.      In this study the effects of FMT on patients with IBS without constipation and bloating will     be investigated in a double blind, placebo controlled RCT.   "
75316|NCT02299960|"     The main purpose of this study is to analyse test-retest-reliability of functional     quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with     heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial     hypertension and diabetic nephropathy. In the same group, test-retest-reliability of     circulating endothelial cells as well as test-retest reliability of non invasive cardiac     output Monitoring will be observed and analysed.   "
75317|NCT02299947|"     The purpose of this study is to answer the following question: Leads a primary coagulation     corrected with a single dose of fibrinogen concentrate after ascending aorta-arc     reconstruction to a decrease in the number of allogenic blood transfusions, compared to     placebo?   "
75318|NCT02299934|"     This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.   "
75320|NCT02299908|"     Acute postoperative pain is one of the most important centers of therapeutic attention in     postoperative phase of any procedure. It is a complex entity that requires a multiple     intervention to be treated and, depending on the intervened surgical site, it has different     approaches.      Despite attempts to reduce postoperative pain by implementing management protocols, rates of     pain prevalence from moderate acute to severe pain are still reported as high as 50% in the     first 24 postoperative hours. Among the surgeries that report greater intensity of     postoperative pain is open inguinal Herniorrhaphy. That is why several techniques have been     described for the management of acute pain in this surgery postoperative, among which PAT     blocking has shown to be beneficial in some studies. However, some reports question its     usefulness but with the emergence of ultrasound-guided techniques for its realization,     interest in this blockage has grown back.      This study aims to demonstrate the utility of the PAT blocking in the management of acute     pain of pre-peritoneal inguinal herniorrhaphy with mesh.   "
75321|NCT02299895|"     Background:      In the field of health promotion, the 'setting approach' has gained increased attention over     the last decades. Following this approach, organizations and governments are urged to invest     in health and health promotion. However, the dissatisfaction with the broad definition of the     term 'setting' has grown. As many health promotion programs are carried out in organizational     settings, substantial work has been done on how to acknowledge organizational factors in     designing and implementing health promotion programs. Organizational settings differ from     others because they can also address their clients as beneficiaries of health promotion     programs, also known as 'client-oriented health promotion'. Among the most prominent     organizational settings for health promotion are schools and hospitals, and more recently,     long-term care (LTC-) facilities. However, dissemination and implementation of     client-oriented health promotion in organizational settings seem to be very challenging. Most     approaches dealing with barriers to health promotion implementation in schools, hospitals,     and LTC-facilities rarely reflect the specific organizational characteristics. This     negligence constitutes both, a research gap in the setting approach and in the design of     health promotion practice. Hence, the aim of this study is to explore professionals'     (teachers', health professionals', care aids') views and attitudes that influence the     implementation of client-oriented health promotion programs between schools, hospitals, and     LTC-facilities in Austria.      Methods:      With that aim in mind, the investigators chose a comparative qualitative design.     Semi-structured interviews will be conducted with 90 professionals (30 in schools, 30 in     hospitals, and 30 in LTC-facilities). In addition, non-participant observations as well as an     extensive document analysis in each setting will be undertaken. The data will be analyzed by     thematic analysis. Comparisons within as well as between the organizational settings will be     conducted using selected categories.      Discussion:      To date, this study is the first of its kind that compares results of individual     semi-structured interviews between different organizational settings. This study investigates     professionals' views and attitudes on facilitating and hindering factors of implementing     client-oriented health promotion programs and thus will provide a solid basis for future     research activities and evaluation studies in the field of health promotion implementation.   "
75322|NCT02299882|"     Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical     infection rates.   "
75323|NCT02299869|"     Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs.     Competitor)of Color Soft Contact Lenses   "
75324|NCT02299856|"     Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection     of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the     Lake Louise Criteria (two of three criteria have to be positive in order to establish the     diagnosis). Although these criteria are accepted and widely used in clinical routine, several     disadvantages exist. Newer parameters like myocardial T1 and T2 mapping, extracellular volume     fraction (ECV) and myocardial strain analysis have the potential to complement or even     replace some of the Lake Louise Criteria and further enhance the diagnostic performance of     cardiac MR in patients suspected of having acute myocarditis. The aim of our study is to     evaluate the diagnostic performance of a comprehensive cardiac MR protocol in patients with     acute myocarditis.   "
75422|NCT02298582|"     The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain     induced by wound care and rehabilitation in the elderly. The project would also provide a     preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.   "
75423|NCT02298569|"     The purpose of this before-after study is to determine the effectiveness of a     multidimensional intervention to increase the rate for early discharge of low-risk mothers     and the healthy newborn in a perinatal network.   "
75325|NCT02299843|"     Currently，the ALPPS (associating liver partition with portal vein ligation for staged     hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends     surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a     research hot spot. However, the procedure has a high morbidity and mortality rate.Using     radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation     band in stage I will reduce the incidence of complications（bile leakage, abdominal     infection,hemorrhage e.t.) The investigators named this technique as Radio-frequency Assisted     Liver Partition with Portal vein ligation for staged hepatectomy （RALPPS）.Investigators     hypothesized that the RALPPS might result in lower morbidity and mortality rate than ALPPS in     the treatment of hepatocellular carcinoma . This Prospective Randomized Controlled Trial is     on the Safety and Efficacy of radio-frequency assisted liver partition with portal vein     ligation for staged hepatectomy for hepatocellular carcinoma.   "
75326|NCT02299830|"     The purpose of this study is to evaluate the efficacy and safety of four interventional     pulmonology techniques for the treatment of malignant central airway stricture.      The four techniques are：        -  cryotherapy        -  argon plasma coagulation        -  stent        -  snare   "
75327|NCT02299817|"     The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis     around uncemented acetabular implants used in total hip arthroplasty. Patients included in     the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a     total of 6 doses with start on day one and every 6 months with last treatment at 30 months.     The primary endpoint will be the change in volume of the osteolytic lesion over 3 years     measured (measured with 3D-CT in cm³).   "
75328|NCT02299804|"     A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120     patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to     evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the     effective dosage for phase IIb clinical study, to study the safety of Levophencynonate     Hydrochloric.   "
75329|NCT02299791|"     The purpose of the ALL Study is to determine the effectiveness of the dissemination of the     ALL intervention from an integrated care setting into Community Health Centers (CHCs) by     measuring changes in diabetes mellitus (DM) population prescription rates for the     medications, using a pre-post comparison within clinics and a staggered, randomized     implementation across clinics.   "
75330|NCT02299778|"     The purpose of this study is to determine whether folate produced by bacteria that live in     our colon can be absorbed in human colon using a stable isotope method. This study would lead     a better understanding of the bioavailability of colonic bacterially-synthesized folate and     its quantitative contribution to whole body folate homeostasis.   "
75343|NCT02299609|"     Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid     for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6     months.   "
75344|NCT02299596|"     This study will compare the outcome after surgery between a group of patients that receives     instructions for prehabilitation training and one group that received standard treatment.   "
75367|NCT02299297|"     This is an open-label pilot study of tofacitinib taken daily for 6 months in the treatment of     moderate to severe AA, and alopecia totalis or universalis, followed by 6 months follow-up     off drug to assess the incidence and timing of recurrence of disease or documentation of     delayed response to treatment. There will be the option of increasing the treatment duration     up to an additional 6 months beyond the initially scheduled 6 months of treatment, if     clinically indicated, and at the discretion of the investigator.   "
75331|NCT02299765|"     Study Title:      Intercalating and maintenance Gefitinib in combination with chemotherapy (gemcitabine plus     carboplatin) as first-line treatment for patients with advanced EGFR mutation-positive     non-small cell lung cancer: A randomized, open-label, multiple-centre study.      Target population-Treatment naive EGFR mutant-positive advanced NSCLC patients.      Study Objectives - Primary Study Objective: To investigate whether intercalating and     maintenance Gefitinib in combination with chemotherapy improve the Progression-Free Survival     (PFS) vs. Gefitinib alone in advanced NSCLC with EGFR activating mutation.      - Secondary Study Objective： To evaluate whether intercalating and maintenance Gefitinib in     combination with chemotherapy improve the Objective Response Rate (ORR), Disease control rate     (DCR), Overall survival (OS), 2-year OS rate, QOL vs. Gefitinib alone.      Evaluation the safety of Intercalating and Maintenance Gefitinib in combination with     chemotherapy.      - Exploratory objective: PFS of arm A vs. PFS 1 + PFS 2 of arm B Dynamic biomarker analysis     using blood sample      a: The PFS 1 of arm B is the time from randomization to disease progression of 1st-line     therapy or death from any cause, whichever occurs first. The PFS 2 of arm B is the time from     the time of PFS 1 to disease progression of 2nd-line therapy or death from any cause,     whichever occurs first.      Study Design-Prospective, open-label, randomized, multi-center study.   "
75332|NCT02299752|"     The aim of the study was to investigate the incidence of glove perforation in cannulation of     blood vessels (CBV) during resuscitation and compare perforation rates between single and     double-gloves.   "
75333|NCT02299739|"     Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal     medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI)     gives rise to the need for large-scale patient studies. We assessed the prevalence of liver     injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.   "
75334|NCT02299726|"     Over one million hospitalizations for acute heart failure (AHF) occur over every year in the     United States, resulting in high mortality, re-hospitalizations, and incurred financial     costs; yet nearly every attempt over the last 10 years to improve outcomes with novel     therapies have all failed. In this proposal, we will study whether a generic drug known as a     mineralocorticoid receptor antagonist (more commonly known as an aldosterone blocker), proven     to reduce morbidity and mortality for chronic heart failure patients, is safe and feasible to     give to AHF patients in the emergency department and during hospitalization for a total of 3     days. The results of this study will provide necessary and sufficient data to design an     efficacy study in a larger population to test whether early use of a high-dose of     mineralocorticoid receptor antagonists will reduce post-discharge morbidity and mortality.   "
75335|NCT02299713|"     The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain     control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived     quality of life and use of pain medications, in people with chronic knee pain.   "
75336|NCT02299700|"     The purpose of this study is to assess the usability of the Janssen Autism Knowledge Engine     (JAKE) as a system to monitor clinical outcomes in autism spectrum disorder (ASD) (severe     abnormalities in the development of many basic psychological functions that are not normal     for any stage in development. These abnormalities are manifested in sustained social     impairment, speech abnormalities, and peculiar motor movements).   "
75337|NCT02299687|"     A clinical trial to investigate the influence of CYP2C19 polymorphism on     pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers   "
75338|NCT02299674|"     The purpose of this study is to examine the path and velocity of the center of mass (CoM) and     center of pressure (CoP) during double support of persons walking with a unilateral     above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and     effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory     movements that affect the smooth trajectory of the center of mass (CoM) during weight     transfer. The lack of control in the foot/ankle complex reduces fine motor movements,     influencing the progression of the CoM and transfer of ground reaction forces represented by     the center of pressure (CoP). Without control of the ankle joint, prosthetic users fall off     of their trailing prosthetic limb during weight transfer, resulting in much more abrupt CoM     and CoP transfers from trailing to leading limb. These abrupt movements during transfer not     only increase stress on the sound limb, but also decrease the subject's energy efficiency     during ambulation. The current study will further examine the CoP path and velocity in     relation to the CoM path and velocity during double support of men with a transfemoral     prosthesis, as well as explore how prosthetic foot ankle stiffness and effective length     affects the CoP path and velocity.   "
75339|NCT02299661|"     DS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to     produce transient dose / exposure dependent increases in erythropoietin levels in subjects     with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will     involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group     investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to     dose will be randomised. On completion of this part of the study an optional fourth dose may     be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B     will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects     (n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from     Part A.   "
75340|NCT02299648|"     This protocol is a screening protocol only. No drug intervention study will be included in     this protocol. However, based on the molecular profiling, patients may be eligible for     targeted agents. However, the molecular profiling doesn't guarantee the enrollment onto the     clinical trial. Currently, the available drugs are AKT inhibitor, MEK inhibitor, Wee1     inhibitor, MET inhibitor. ATR inhibitor and other agents may be available in the context of     clinical trials depending on the availability.   "
75341|NCT02299635|"     This study is designed to evaluate the preliminary anti-tumor activity and tolerability of     PF-03084014 when administered as a single agent in the treatment of patients with advanced     triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch     receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for     genomic alterations in Notch receptors (NA-)   "
75355|NCT02299453|"     This randomized clinical trial is testing if telephone-administered interpersonal     psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS.   "
75345|NCT02299583|"     Background: International studies have shown that a substantial number of children and     adolescents are exposed to potentially traumatic events. Many of these children and     adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted     to health care departments shortly after exposure as the most common types of traumatic     events are accidental injury, serious somatic illness or death of someone close. There has     been some research on early psychological interventions for prevention and treatment of PTSD.     However, very little research has examined the efficacy of trauma-informed practice among     health care professionals (HCPs). The present trial aims to evaluate and compare     trauma-informed health care with usual practice.      Methods/Design: The primary clinical question under investigation is the efficacy of an     early, trauma-informed intervention for the prevention of PTSD in children and adolescents     following exposure to a potentially traumatic event. The trail compares a standardized     trauma-informed practice with usual care (no intervention) in health care departments     receiving children and adolescents after exposure to determine if trauma-informed care is     associated with a reduction in psychological outcome measures over time. Specifically, the     investigators examine the efficacy of health care professional's active use of     trauma-informed standards of action and a trauma training program for HCPs in the     intervention group. The primary outcome will be a reduction in trauma, anxiety and depressive     symptoms on self-reports in the active intervention compared to usual care.      Discussion: This trial will be the first controlled trial to examine a trauma-informed     intervention carried out by HCPs. It will provide the first evidence on the efficacy of     health care delivered by trauma-educated HCPs using trauma-informed standards of action. A     successful implementation of this protocol will support the thesis that prevention of PTSD     among children and adolescents benefits from a focus on the practice of HCPs. If efficacious,     the results will be a call for future research to extend the investigation of interventions     from psychological treatment to HCP-based care.   "
75346|NCT02299570|"     This is the first prospective, multi-center, double-blinded, randomized controlled study of a     microbiota suspension derived from intestinal microbes. Patients who have had at least two     recurrences of C. difficile infection (CDI) after a primary episode and have completed at     least two rounds of standard-of-care oral antibiotic therapy or have had at least two     episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients     whose CDI returns in less than 8 weeks after the last assigned study treatment may be     eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.   "
75347|NCT02299557|"     This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on     anal resting pressure and fecal incontinence in patients with spinal cord injury.     Approximately 17 subjects are expected to complete this 10 weeks study that will include two     treatment periods of 4 weeks each, and one 2 weeks wash out period.   "
75348|NCT02299544|"     BlueWind system safety and performance in treatment of patients diagnosed with overactive     bladder (OAB)   "
75349|NCT02299531|"     This study investigates the effect of varying both energy density and portion size of all     foods at lunch on preschool children's intake. The foods used in this study are     commercially-available, commonly-consumed foods with typical variations in energy density.     The primary aim of the study is to investigate the independent and combined effects of energy     density and portion size on preschool children's intake at a meal composed of foods typically     served to this population.   "
75424|NCT02298556|"     To describe the effectiveness of angiotensin-converting enzyme inhibitor and     non-dihydropyridine calcium channel blocker single pill combination on systolic blood     pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes   "
75350|NCT02299518|"     This phase I trial studies the side effects and best dose of selinexor when given together     with etoposide with or without mitoxantrone hydrochloride and cytarabine in treating patients     with acute myeloid leukemia that has returned (relapsed) or has not responded to treatment     (refractory). Selinexor may help stop the growth of tumor cells by blocking an enzyme needed     for cancer cell growth. Drugs used in chemotherapy, such as etoposide, mitoxantrone     hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving chemotherapy together with selinexor work better in treating relapsed or     refractory acute myeloid leukemia.   "
75351|NCT02299505|"     A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib     taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with     that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged     (ALK-positive) metastatic non-small cell lung cancer (NSCLC)   "
75352|NCT02299492|"     This proposed study addresses the problem of service disengagement within the mental health     system. No matter how effective mental health practices are now or become in the future, they     are of little value should persons with mental illnesses continue to choose not to receive     them. Consumers have attributed their disengagement from care to having poor alliances with     care providers, including experiences of not being listened to and not being offered the     opportunity to make decisions and collaborate in their own treatment. Person-centered care     planning is a field-tested intervention designed to maximize consumer choice and ownership of     the treatment process. Providers collaborate with consumers to develop customized plans that     identify life goals and potential barriers to achieving them. The proposed study tests the     effectiveness of Person-Centered Care Planning (PCCP) designed to target barriers and     efficiently implement PCCP throughout an agency. By conducting a randomized controlled trial     with 14 community mental health clinics from two states, the study will assess whether PCCP     improves service engagement and consumer outcomes. The study will also utilize qualitative     methods to understand how care planning impacts service engagement and how implementation     processes influence organizational and provider level behavior. Designed to bridge the     science to services gap, this study focuses on two priorities identified by the NIMH     Diversion of Services and Intervention Research: developing models and methods to implement     effective mental health services in the community and the study of personalized mental health     care.   "
75353|NCT02299479|"     Increased daytime activity in children and adolescents with type I diabetes is known to be     associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical     study to assess the feasibility of using activity monitor data to adjust insulin pump basal     rates and see whether we can help prevent overnight hypoglycemia following high activity     days. We plan to carry this out by enrolling 20 subjects (10 subjects 1 to <7 years old and     10 subjects 7 to 17 years old) with type 1 diabetes managed on insulin pump therapy and     having them wear activity monitors and CGMs for 3 months. After an initial two-week period to     establish activity baselines, we will recommend nighttime basal insulin rate adjustments     based on activity monitor, CGM and insulin pump data.   "
75354|NCT02299466|"     The purpose of study is to build a Canadian HTPN Registry to collect pertinent demographic     and clinical data on the HTPN population in Canada and to determine the factors affecting     survival, complications and TPN-dependency. These results will help establish standards of     practice and develop future multi-center studies. This will greatly benefit the HTPN patient     population.   "
75357|NCT02299427|"     Dog bites result in over 800,000 doctor/ER visits, 6000 hospitalizations, and a dozen deaths     each year in the United States. By a large margin, children suffer the highest risk - and     children typically are bitten by familiar dogs in familiar places. Several programs exist to     reduce pediatric dog bite risk, but few are empirically-supported or theoretically-motivated.     None are widely disseminated. This study builds from existing child dog bite prevention     programs to develop and then evaluate a website to teach children safe interactions with     dogs. The website will be interactive, entertaining, and engaging, allowing children (target     ages 4-6) to learn in a technologically-sophisticated and interactive environment. It will be     developed based in behavioral theory. Hearkening child development theory, it will teach and     permit practice of cognitive skills that develop in early childhood and are critical to     safety with dogs: impulse control, perspective taking, and attention to details. Hearkening     health behavior change theory, the website will help children and their parents perceive     personal vulnerability to bites, recognize normative behavior to protect themselves, and have     personal motivation to change previous habits. Overarching the website design will be goals     to create an engaging and entertaining environment, and to facilitate cognitive and     behavioral change on the part of both child and parent via multiple mechanisms. Besides     teaching children, the website will educate parents via an innovative messaging system     triggered by child attainment of points and skill levels.      Following website development, an evaluation study will investigate usability and efficacy of     the website using a repeated measures pre-test, post-test experimental design. 68 children     ages 4-6 will be recruited, complete a pre-intervention assessment evaluating knowledge and     behavior relevant to dog safety via multiple methods, and then be randomly assigned to use     either the newly-developed dog safety website or a control pedestrian safety website at home     over the subsequent 2 weeks. Frequent reminders will encourage website use. Following the     2-week period, all children will return for a post-intervention assessment battery to     evaluate knowledge and behavior change. Data will be analyzed using descriptive and     inferential statistics, with primary hypotheses tested using linear mixed models.   "
75358|NCT02299414|"     The purpose of this study is to evaluate whether a blood pressure treatment strategy during     pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults     (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP     is severe) is effective and safe.   "
75359|NCT02299401|"     This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and     acceptability of two medical abortion regimens that are commonly used in Latin America. The     first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour     intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in     three hour intervals. This study will also aim to assess the feasibility and acceptability of     a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.   "
75425|NCT02298543|"     The purpose of this study is to evaluate the natural course of coronary spasm patients     presenting aborted sudden cardiac death and analyze risk factors.   "
75426|NCT02298530|"     Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure     during acute mental stress.   "
75360|NCT02299388|"     The investigators are conducting this research to study the effect of Liraglutide on blood     pressure. Several studies have shown increased cardiovascular complications and deaths in     diabetics with hypertension. The importance of blood pressure control in diabetes has been     shown in many clinical trials. No drug already approved for treating Type 2 Diabetes Mellitus     is known to reduce blood pressure along with improving diabetes. However, prior research     studies with liraglutide have suggested that treatment with liraglutide improves blood     pressure. This effect is seen very quickly and even prior to any weight loss. The mechanism     behind this effect is yet to be determined.   "
75361|NCT02299375|"     This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15     milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to     standard of care (SoC).      The primary objective of this study is to explore the therapeutic potential of losmapimod as     a treatment to reduce the rate of exacerbations in the subset of participants with     moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more     moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood     eosinophils at screening. As secondary objectives safety, effects on lung function, quality     of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be     evaluated.      The duration of the treatment period is variable but will be at least 26 weeks and up to a     maximum of 52 weeks, with the end of study date being established once the final participant     has been randomized. The purpose of the variable dosing regimen is to enable participants to     remain in the study for a longer duration, as it is anticipated that this will increase the     likelihood of observing exacerbation events without increasing the overall study duration. It     will also enable safety data on dosing periods beyond 6 months to be generated.      Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be     randomized to the study. Sample size re-estimation will be performed during the course of the     study to potentially increase the sample size up to a maximum of 600 participants.   "
75362|NCT02299362|"     The purpose of this study is to examine the treatment, both surgical and non-surgical, of     patients with any form of early onset scoliosis. Such treatment may include the use of growth     friendly devices that are surgically or magnetically lengthened; or the use of serial body     casting or bracing, or observation. Outcomes examined will be what can be seen physically on     the patient and on x-ray, as well as parent perception of how the treatment effects their     child with the use of a health-related quality of life (HRQOL) questionnaire.   "
75363|NCT02299349|"     Despite a robust multimodal pain management regimen, patients undergoing total knee     arthroplasty (TKA) continue to report low satisfaction with postoperative pain management.     Patient satisfaction further declines with any adverse event such as a drug reaction to     neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain     management throughout the hospital experience is warranted to improve patient satisfaction     and the possibility of related adverse events. The purpose of this study is to examine if     there is a difference in post operative pain and morphine (MSO4) total consumption for     hospitalized TKA patients without femoral nerve block receiving an intra-operative     periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.   "
75364|NCT02299336|"     The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) end-point.     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on     the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment     criteria will be eligible for focal laser treatment every 90 days.   "
75365|NCT02299323|"     The primary objective of this study is to evaluate radiographic outcomes, intra-operative     parameters, clinical outcomes, and patient satisfaction following circumferential fusion     using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for     the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6     months of non-operative treatment.   "
75368|NCT02299284|"     A randomized control trial to test the efficacy of a new treatment involving intensive     home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive     home-based functional lower-limb training in children with hemiplegia. The protocols have     been developed at TC Columbia University to be child friendly and draw upon the investigators     experience since 1998 with intensive movement therapy in children with cerebral palsy. The     aim is to promote either the use/coordination of movement of the hands or improve lower-limb     balance, strength, and function. Caregivers will be trained at the investigator center and     then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of     activities with their child in their own home. The activities will be supervised by the     investigators team via computer. Participants do NOT need to live in the New York City area,     but a one-time weekend visit to the investigators center is required for training. All     measurement and treatment is performed in the home.      Participants are randomized to receive either HABIT or lower-limb training. If caregivers     wish, they may chose to be crossed over at the end of the study and trained to receive the     other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more     information: http://www.tc.edu/centers/cit/   "
75369|NCT02299271|"     This study evaluates post-operative pain management and narcotic consumption in patients     receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca     block with saline for total hip arthroplasty.   "
75370|NCT02299258|"     gastric outlet obstruction tailored versus standard stents for malignant gastric outlet     obstruction treatments   "
78336|NCT02260531|"     This research study is evaluating the effectiveness of the drug called cabozantinib (alone or     in combination with trastuzumab) as a possible treatment for advanced breast cancer in which     the cancer has spread to the brain.   "
75371|NCT02299245|"     Coronary heart disease (CHD) is one of the diseases characterised by biological aging as one     of the important risk factors in several epidemiological studies. The mean telomere length     and telomerase activity serve as markers for the biological age at the cellular level, with     shorter telomeres and lower telomerase activity defining the increased biological age.     Telomere length and telomerase activity, therefore, correlates with the risk of CHD and     atherosclerosis. A present study states that the treatment with a statin is associated with a     reduction in the number of clinical events but only in individuals with increased risk based     on their telomere length. This suggests a positive relationship of telomere and telomerase     system with the treatment with statins in CHD patients.   "
75372|NCT02299232|"     Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status     I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1     received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From     the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation     Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and     separation-score was noted. If intranasal sedation failed, an intravenous canula was placed     and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to     receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.   "
75373|NCT02299219|"     Cancer is the most common potentially fatal disease of adolescence and the Internet     represents an ideal means to deliver education, self-monitoring capabilities, and social     support to enhance disease self-management by adolescents with cancer. While two interactive     coping websites exist for young people with cancer, they are: (1) not interactive, (2) do not     focus on helping youth gain skills for transition and independence, and (3) do not provide     opportunities for meaningful social support. In summary, there is a crucial need to develop a     comprehensive interactive Internet-based self-management program targeting AWC that is     comprised of cancer education, self-management skills, and opportunities for social support,     and that is cost-effective.   "
75374|NCT02299206|"     This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority     controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to     Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis     who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups     will administer the product with each diaper change throughout the course of the study     period. Product can be applied liberally as needed. Diapers and skin cleansing interventions     will stay constant throughout the treatment period. Subjects will be assessed by the study     doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also     be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis,     a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and     observations related to product use and the baby's comfort level. Parents/caregivers will     also be given a questionnaire rating the use of the study products.   "
75375|NCT02299193|"     The purpose of this study is to compare the effect of 6-weekly, 20 minute sessions of 2     online behavioral sleep interventions (cognitive behavioral therapy or healthy sleep habits)     on blood pressure, sleep, depressive symptoms and anxiety in people with insomnia and     prehypertension or hypertension.   "
75386|NCT02299050|"     Purpose This study will examine the effect of the addition of Cycloset upon glucose     metabolism (glycemic control including post prandial glucose metabolism) in individuals with     inadequately controlled (HbA1c 7.5-10.0) type 2 diabetes (T2DM) who are already on Bydureon     (exenatide once weekly) or Victoza (liraglutide once daily) as part of their standard care.      Both a mechanistic rationale and empirical experimental evidence implicate a beneficial     interaction between bromocriptine and the incretin mimetics (GLP-1 analogs) upon postprandial     hyperglycemia in insulin resistant states. One of the actions of the incretin mimetics such     as the GLP-1 analogs is to stimulate postprandial beta cell insulin secretory response to     plasma glucose (see drug labeling information; www.fda.gov). Thus the combination of Cycloset     that is working as a post prandial insulin sensitizier with therapies that increase post     prandial insulin would be expected to provide complimentary glucose lowering effects. To     date, however, no such studies investigating the interactive effects of a GLP-1 analog and     Bromocriptine-QR (Cycloset) have been conducted in humans.      Condition - Type 2 Diabetes. Intervention - Cycloset. Phase - Phase 4      Study Type: Interventional Study Design: Treatment, Single Group Assignment, Open Label, N/A,     Safety/Efficacy Study      Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients     Inadequately Controlled on GLP-1 Analogue Therapy   "
75376|NCT02299180|"     Aims: Advance care planning (ACP) is considered to be one of the most promising interventions     to enable patients with life limiting illnesses to receive treatment at the end of life (EOL)     according to their own preferences and to promote EOL conversations between patients and     their health care providers. Through a 2-arm randomized controlled trial (RCT) of patients     with Class III and IV heart failure (New York Heart Association Functional Classification),     we propose to assess:        1. Whether patients in the ACP arm have a greater likelihood of receiving EOL care          consistent with their preferences as stated in the latter of the last ACP document or          the last patient interview, compared to patients in the control arm.        2. Heath care costs during study duration between patients in ACP and control arms.        3. Patient's understanding of own illness and their participation in decision making          between the ACP and control arms.        4. Patient's quality of life, anxiety and depression between ACP and control arms.      Methodology: A total of 254 patients with advance heart failure will be randomized to receive     intervention (ACP arm; N=127) or usual care (control arm; N=127).      The RCT will be conducted at the National Heart Centre and Singapore General Hospital.     Patients in both arms will be followed for one year or till death, whichever is earlier, and     interviewed every 4 months during this duration.      Clinical Significance: If benefits of ACP are shown to add value through this trial, then     this study will help to promote acceptance of ACP among patients and health care providers     across Singapore and elsewhere.   "
75377|NCT02299167|"     The optimal anesthetic technique would provide excellent operating conditions, rapid     recovery, early discharge, no postoperative side effects, and high patient's satisfaction. In     addition to increasing the quality and decreasing the costs of the anesthetic services (1).     Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific     type of surgery - has become very popular technique) 2(for some orthopedic and gynecological     surgeries [3-9].      Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards     S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries     (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle     block (11, 12).      Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been     used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has     yet to be determined.      The objective of this study is to determine the minimal effective dose of hyperbaric spinal     bupivacaine required to induce a reliable and satisfactory saddle block for perianal     surgeries (using a modified Dixon's up-and-down method.   "
75378|NCT02299154|"     This study aims to prospectively examine the memory problem perceptions of patients with     memory complaints [MCs] and their accompaniers during the diagnostic process.   "
75443|NCT02298309|"     The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of     a Test & Treat TB strategy on a mobile HIV screening unit in South Africa and (2) to assess     the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for     maximizing linkage to TB care and treatment completion.   "
75380|NCT02299128|"     Therefore, the purpose of this pilot study is to determine the feasibility of conducting a     randomized clinical trial (RCT) on physical therapist treatment for dizziness after     sports-related concussion. The specific research question for this pilot RCT is: What is the     feasibility of conducting a RCT on athletes who have dizziness 10 or greater days after a     sports-related concussion to explore the effectiveness of directed vestibular rehabilitation,     neuromotor retraining, and/or manual physical therapy (PT) when compared to sham treatment?     The findings of this study (for both feasibility and effect size) will be used to inform and     direct revisions to the methods for a larger RCT on this population.      Primary Aims:      Specific Aim 1: Assess the feasibility of the following: recruitment and retention of     participants, required resources for project management, and assessment of patient safety.      Specific Aim 2: Estimate the size of the effect between skilled physical therapist     intervention and a sham treatment for the recovery rate for athletes with a concussion who     have dizziness 10 - 14 days post-concussion.   "
75381|NCT02299115|"     Infantile Spasms, is an rare age-specific epilepsy of early infancy. A 2012 American Academy     Neurology/ Child Neurology Society practice parameter update on the medical treatment of     infantile spasms concluded: adrenocorticotrophic hormone or vigabatrin may be offered for     short-term treatment of infantile spasms. There was insufficient evidence to recommend the     use of prednisolone, dexamethasone, and methylprednisolone. The cost of ACTH and the side     effects of vigabatrin have led to the consideration of alternative medications to treat     infantile spasms. The United Kingdom Infantile Spasms Study (UKISS) in 2004, comparing the     efficacy of intramuscular synthetic ACTH to high dose oral prednisolone, showed a response     rate of 74% for ACTH and 70% for prednisolone. Since the UKISS paper was published, many     institutions in the United States and Australia have used oral prednisolone instead of ACTH,     partly due to the exorbitant cost of intramuscular ACTH but also its ease of use and better     adverse event profile compared to ACTH. Prednisolone and vigabatrin are both oral     medications, which can be initiated promptly upon diagnosis of infantile spasms, expediting     treatment and shortening treatment lag time. Because the UKISS trial is the only Class 3     study providing evidence for oral prednisolone in the first-line treatment of infantile     spasms, further prospective studies are needed.   "
75382|NCT02299102|"     This single center, randomized, controlled trial will compare the manual standard bone marrow     aspiration device to the powered ported bone marrow aspiration device for use in the iliac     crest in healthy adult volunteers. The study will compare the subjects' perceived level of     pain, time to sample acquisition, and quality of specimen yield of these devices. To serve as     their own control, each subject will receive bilateral bone marrow aspiration procedures     using both the manual standard and powered ported devices.   "
75383|NCT02299089|"     This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy,     and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a     functional, well-differentiated NET, with carcinoid symptoms.   "
75384|NCT02299076|"     The purpose of this study is to determine whether a behavioral economics solution impacts     smoking cessation engagement and quit rates.   "
75385|NCT02299063|"     The investigators hypothesize that in addition to a known sympatholytic effect,     intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and     structure attenuating ischaemia-reperfusion and end-organ injury for children with non     cyanotic congenital heart defects having corrective heart surgery.   "
75387|NCT02299037|"     The purpose of the study is to determine if pre-operative neuropsychological characteristics,     apolipoprotein E4 status and/or cerebrospinal fluid (CSF) and serum biomarkers can predict     those most at risk of post-operative delirium. Patients over the age of 65 years undergoing     elective primary hip or knee arthroplasty in Musgrave Park Hospital are invited to take part.     Participants undergo a pre-operative neuropsychological assessment which is repeated 6-12     weeks post-operatively at the time of surgical review appointment. At the time of surgery     advantage is taken of the necessary venous cannulation and spinal anaesthetic to gain venous     blood and CSF samples respectively. Venous blood is also sampled post-operatively. Patients     are assessed daily for delirium, using the Confusion Assessment Method, until discharge.   "
75388|NCT02299024|"     The investigators overall study objective is to improve patients knowledge and safe use of     opioid pain relievers upon discharge from the Emergency Department.   "
75389|NCT02299011|"     The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro     drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have     biodegradable polymer for the treatment of all-comers' coronary artery diseases.   "
75390|NCT02298998|"     This is a two-arm, randomized-controlled pilot study with 2 year duration. The intervention     refers to surveillance based on the European Association of Urology (EAU) guidelines and the     control refers to surveillance based on the American Urological Association (AUA)     guidelines.   "
78337|NCT02260518|"     The purpose of this study is to examine the impact of a lifestyle intervention on gestational     weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care     control group.   "
75391|NCT02298985|"     Schizophrenia is still remained one of the disabling disorders despite progress in treatment     of mental disturbances. Ten to thirty percents of patients have a little or no benefit from     treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of     these patients has remained a persistent public health problem since medication-resistant     patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated from     this perennial herb. It possesses a variety of pharmacological activities, including     anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses     the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of     curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic     schizophrenia patients.   "
75392|NCT02298972|"     This study evaluates the value of a nursing symptom support en selfmanagement intervention     for adult patients with cancer treated with chemotherapy. Using a prospective sequential     design with a comparison group who receives standard care and a (later) intervention group     who gets the nursing intervention, we will evaluate the effect of this nursing intervention     on overall symptom distress (primary outcome) and other measures of symptom burden,     self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews     with some participants of the intervention group, we will study the patient experience of the     intervention.   "
75393|NCT02298959|"     This phase I trial studies the side effects and best dose of ziv-aflibercept when given     together with pembrolizumab in treating patients with solid tumors that have spread to other     places in the body. Ziv-afibercept works by decreasing blood and nutrient supply to the     tumor, which may result in shrinking the tumor. Monoclonal antibodies, such as pembrolizumab,     may block tumor growth in different ways by targeting certain cells. Giving ziv-aflibercept     together with pembrolizumab may be a better treatment for patients with advanced solid     tumors.   "
75394|NCT02298946|"     Background:      - T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep     T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in     people with cancer. They think the drug might work even better when combined with a certain     type of radiation therapy.      Objective:      - To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic     body radiation therapy (SBRT) directed to the liver.      Eligibility:      - People age 18 and older with metastatic colorectal cancer. Their cancer must have spread to     the liver and not be responding to treatment.      Design:        -  Participants will be screened with a medical history, physical exam, and blood and urine          tests. Their tumors will be measured with computerized tomography (CT) scans or magnetic          resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an          electrocardiogram (ECG) heart test.        -  Participants will have a small part of their tumor removed by needle (biopsy).        -  Participants will have 8 study visits over about 10 weeks.        -  At 1 visit, they will have another tumor biopsy.        -  At 1 visit, they will get a chemotherapy drug through a vein (IV).        -  At 6 visits, they will receive AMP-224 through an IV.        -  At 1 or 3 visits, they will have SBRT. CT scans will map the position of their tumor.          Radiation beams of different intensities at different angles will be directed to the          tumor.        -  At all visits, some screening procedures may be repeated.        -  After treatment ends, participants will have 7 follow-up visits over about 5 months.          Blood will be drawn. Some screening procedures may be repeated.   "
75405|NCT02298803|"     Hypoglycaemia is the most common acute complication of diabetes and can limit therapeutic     efforts to improve glycaemic control. It is a potential side effect of drugs used to treat     diabetes, particularly with the use of sulfonylurea (SU) treatment. It has been demonstrated     that hypoglycaemia causes the prolongation of corrected QT (QTc) interval, which is     associated with ventricular arrhythmias and sudden death. Hypoglycaemia in T2DM has recently     come into focus with the results of the ACCORD, ADVANCE and VADT trials.      In this study, the investigators aim to examine the association of hypoglycaemia and glucose     fluctuations on QT-interval and QT variability in patients with type 2 diabetes treated with     SU. Patients will be studied using simultaneous Continuous Glucose Monitoring (CGM) and     ambulatory ECG monitoring (Holter).      Study participants will be recruited from the Diabetes Centre, RPAH or from specialist     consulting rooms. They will be required to attend the Diabetes Centre on two occasions.      At the first visit, blood will be collected and CGM and Holter monitoring commenced. At Visit     2, i.e. two days later, the patient will return to the Diabetes Centre to have the equipment     removed. The data obtained from the CGM and Holter monitor will then be downloaded for review     and analysis.   "
75406|NCT02298790|"     The goal of this application is to understand the connection between people's eating habits     and the risk for developing diabetes, obesity, and cardiovascular disease.   "
75395|NCT02298933|"     Background:      - Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens     when people do not have enough normal platelets. Getting a transfusion of another person s     platelets can help stop too much bleeding. But because these cells are from other people, the     body may reject them,putting them at risk for serious bleeding complications. This conditions     is called alloimmune platelet refractoriness . There are evidence that in many patients,     platelet counts fail to increase after a platelet transfusion because the transfused     platelets are destroyed by the body s defence soldier, called complement . Researchers want     to see if a drug, that inhibits complement, can help increase platelet levels and reduce     bleeding      Objectives:      - To see if eculizumab increases platelet levels more after a transfusion. To see if it     reduces the chance of bleeding too much.      Eligibility:      - Adults 18-75 years old who have thrombocytopenia and alloimmune platelet refractoriness.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Participants will have the procedures listed below. They can have them while they are in          the hospital. Or they can go to the outpatient clinic for them. Each visit may take up          to 3 hours.        -  Participants will get a meningitis vaccine if needed. Then they will get the study drug          as an infusion.        -  Participants will have a platelet transfusion. Their blood will be drawn every 24 hours          until the platelet count is less than 10,000 per 1 microliter of blood.        -  They will take antibiotics for 14 days.        -  Participants will have a checkup and blood drawn twice a week for 2 weeks. They will get          more transfusions if needed.   "
75396|NCT02298920|"     This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six     male healthy volunteers.   "
75397|NCT02298907|"     The present study is a retrospective analysis of prospectively collected clinical data.     Anonymized data from patients collected during routine clinical care from 7 major colorectal     units in the UK who perform pre-operative cardiopulmonary exercise testing will be pooled at     a central location (Aintree University Hospitals, Liverpool) and used to validate the     relationship between cardiopulmonary exercise testing (CPET) variables and short term     post-operative outcomes after major colorectal surgery. Here the investigators will attempt     to validate a study entitled Cardiopulmonary exercise variables are associated with     postoperative morbidity after major colonic surgery - a prospective blinded observational     study previously published by our team in Liverpool .   "
75427|NCT02298517|"     The aim of this study is to evaluate the effects of the use of breathing exercises with     inspiratory loading on respiratory muscle strength and endurance, lung volumes and capacities     and thoracoabdominal mobility in patients after bariatric surgery.      It is believed that the use of inspiratory load may mitigate the negative effects of surgical     trauma on respiratory muscle dysfunction, preserving respiratory muscle strength, lung     volumes and diaphragm mobility, thus reducing the risk of pulmonary complications in the     postoperative period.   "
75398|NCT02298894|"     Despite the wide availability of advanced lipoprotein tests, no reference standard exists for     Low Density Lipoprotein Cholesterol (LDL-C) due to inherent problems with each of the assays.     Newer methods for estimating LDL particle numbers, including nuclear magnetic resonance (NMR)     spectroscopy and vertical auto profile (VAP) are currently under investigation. NMR has been     proposed as having the best correlation with adverse cardiovascular outcomes. Unfortunately,     the accuracy of LDL-C or LDL particle number measurements is currently not monitored by     national standardization programs. Direct comparisons between the various testing methods     have been limited restricting our ability to accurately interpret and compare values across     vendors and lipid parameters.      Our hypothesis is that:        1. LDL particle count numbers, as determined by NMR (Liposcience), provides the best          estimates of cardiovascular risk.        2. Discrepancies exist between the LDL particle count by NMR and other values as presented          by calculated LDLC and directly measured LDL (VAP and ion mobility).      The investigators will enroll 100 patients recruited from the Lipid Clinic at the Scripps     Center for Integrative Medicine. Each patient will have one blood draw from which four tests     will be analyzed. Risks are associated with drawing blood, which will be minimized by using     Scripps Clinic Lab technicians. The potential loss of personal health information will be     reduced by limiting access to study and lab staff and keeping information password-protected     on Scripps servers.   "
75399|NCT02298881|"     The purpose of this study is to collect samples from the surface of eyelids to try to grow     and identify bacteria or fungus that might be present, and to try to understand why people     have dry eye symptoms.   "
75400|NCT02298868|"     The purpose of this study is to determine the safety and efficacy of the medication Baclofen     for treatment of muscle cramps in patients with cirrhosis.   "
75401|NCT02298855|"     The purpose of this study in women who have completed primary treatment for ovarian cancer is     to investigate the effects of individualised follow-up care delivered by a nurse compared to     conventional medical follow-up on quality of life and mood. The investigators aim to     determine if the individualised treatment is acceptable to women compared to the conventional     treatment.   "
75402|NCT02298842|"     This study sought to verify that the in vitro quality (functional assays) of platelets     collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored     for 1, 5, and 7 days meet FDA requirements.   "
75403|NCT02298829|"     This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a     12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month     open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After     participation in one of the aforementioned studies, subjects will be followed yearly for up     to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits   "
75404|NCT02298816|"     The goal of this study is to develop a vaccination registry system for Aurora Health Care     patients newly diagnosed with MM and other B-Cell Hematologic Malignancies in order to     prospectively characterize vaccination history and outcomes such as infection in these     patients at Aurora Health Care. Additionally hospitalization rates, cost analysis, infection     (influenza, pneumonia, other) related to vaccination in this patient population will be     evaluated.   "
75417|NCT02298647|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of     metachromatic leukodystrophy disease from plasma and saliva. Testing for clinical robustness,     specificity and long-term stability of the biomarker.   "
75407|NCT02298777|"     Currently investigators do not have diagnostic and prognostic markers for SSc which almost     always starts with a vascular disease (Raynaud's disease) isolated for several years.      The primary purpose is to highlight discriminating metabolic profiles depending on the     characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular     lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3     years).      Secondary purposes:        -  Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs        -  Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective          tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy          controls        -  Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc          patients   "
75408|NCT02298764|"     Aim The aim is to test whether a short psychotherapeutic intervention targeting Post     Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the     outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain     development.   "
75428|NCT02298504|"     In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy     or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves     removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the     remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is     to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the     treatment of deep decay in children's primary molars.   "
75566|NCT02296697|"     Patients admitted in the Emergency Service that have pressure ulcers will be selected by     eligibility criteria and randomized into three groups according to the adopted therapy: wound     dressing (CG); wound dressing + high-frequency generator group (GAF); and wound dressing +     low-level laser therapy group (GLBP).   "
75409|NCT02298751|"     Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond     well during evidence-based psychological treatment, but also that a large proportion relapse     when discharged from treatment and confronted with alcohol in real life. Cue Exposure Therapy     (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the     likelihood of relapse. The aim of this study is to investigate whether CET as aftercare     increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals.      Design and methods: The study is implemented as an investigator-blinded randomized controlled     trial. A total of 300 consecutively enrolled AUD patients, recruited from an alcohol     outpatient clinic will be randomized to one of the three following aftercare treatment     groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n = 100),     and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental groups     ((A) and (B)) will achieve better treatment outcomes as compared to the control group ((C)),     and It will be explored whether CET as smartphone application is as effective as CET as group     therapy. The groups will be compared in a number of parameters including alcohol intake,     cravings and copings-strategies.      Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will     make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT     approach. Although, CET is most often regarded as one of the behavioral methods in CBT, there     appears to be segregation in the empirical literature when it comes to treatment of addictive     disorders. However, CET may allow the patient to practice and gain control over alcohol cue     reactivity and associated high-risk situations in an inter-mediating therapeutic context     before the patients inevitably are confronted by them. In this way, one might expect the     transition from treatment to daily life less overwhelming and CET may help prevent relapse in     the long term. Thus, CET may be particularly suitable as aftercare.   "
75410|NCT02298738|"     Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most     common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at     particular risk of development of atrial fibrillation. Renin-angiotensin-aldosteron system     (RAS) which is activated in hypertension may be the underlying mechanism of AF among     hypertensive patients.      Vitamin D deficiency has been shown to be involved in the pathogenesis of hypertension,     cardiovascular disease and obesity. Increased RAS activity is one of the postulated     mechanisms by which vitamin D deficiency may trigger the development of hypertension and     various cardiovascular diseases. On the basis of these data we hypothesized that     hypovitaminosis D might be associated with new-onset AF among patients with hypertension.   "
75411|NCT02298725|"     To determine if consumption of different diet plans that both are nutritionally-adequate and     provide energy to maintain body weight, alters fasting insulin concentrations, shifts other     common clinical markers of metabolic disease risk, and affects metabolomic profiles that     reflect glucose, lipid, and amino acid metabolism.   "
75412|NCT02298712|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Hurler     disease from plasma. Testing for clinical robustness, specificity and long-term stability of     the biomarker.   "
75413|NCT02298699|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Sly disease     from plasma and saliva. Testing for clinical robustness, specificity and long-term stability     of the biomarker.   "
75414|NCT02298686|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Sanfilippo     Type A-B-C-D disease from plasma and saliva. Testing for clinical robustness, specificity and     long-term stability of the biomarker.   "
75415|NCT02298673|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of     Mucolipidosis Disorder type I, II, III, IV disease from plasma. Testing for clinical     robustness, specificity and long-term stability of the biomarker.   "
75416|NCT02298660|"     The purpose of this study is to investigate the impact of 200 U intradetrusor injected     OnabotulinumtoxinA (Botox, Allergan, Inc.) (20 sites, trigone sparing) for neurogenic     detrusor overactivity (NDO) and its role on reducing autonomic dysreflexia (AD) in those with     chronic, traumatic spinal cord injury (SCI). In clinical practice, urinary bladder     dysfunctions are commonly associated with episodes of AD. If AD is misdiagnosed or poorly     managed, it may result in myocardial infarction,stroke, seizure, intracerebral hemorrhaging     or even death. Reducing AD would dramatically improve the health and well-being of Canadians     with SCI, and positively impact health care costs. There are an estimated 7,343 hospital     re-admissions due to SCI-related conditions in Canada every year, with an estimated 5-year     cost of $661 million. Reducing hospital re-admissions for secondary complications of SCI by     only 10% over this time period could result in a costs savings of $66 million for Canada.      Considering these statistics, the present study could be a first attempt to evaluate the     economic impact of using Botox to manage the urinary bladder following SCI. We will be able     to examine its impact on episodes of AD and consequently calculate the cost saving for the     Canadian health system. A significant number of individuals with SCI will require frequent     emergency room visits due to episodes of uncontrolled AD that originate predominately from     the urinary bladder. There is clinical evidence demonstrating that costs of bladder     management following SCI will depend on the understanding of the volumes that the urinary     bladder can safely hold. This is one of the positive outcomes that have been established in     previous trials of Botox therapy for the neurogenic bladder.      Hypothesis: 200 U of intradetrusor injected Botox (20 sites, trigone sparing) for neurogenic     bladder detrusor hyperreflexia will decrease the severity of AD in individuals with SCI one     month following treatment.   "
75482|NCT02297802|"     The purpose of this study is to provide access for a single patient to PD-0325901 who was     previously enrolled in a phase I clinical trial.   "
75420|NCT02298608|"     Background:      Electroporation or electropermeabilisation is a novel technique with the potential to     overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling     between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied     current reaches a certain threshold these 'nanopores' become permanent resulting in cell     death. The use of electric current means that IRE is not susceptible to 'thermal sink'     leading to consistent ablation results. IRE ablation targets the cell membrane, sparing     tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting     system.      The first in human studies have proven the safety of IRE for the ablation of small renal     masses. However the efficacy of IRE through histopathological examination of an ablated renal     tumour has not yet been studied, compromising the correct and scientific evaluation of this     new technology.      Primary Objectives:        -  To determine the efficacy of IRE ablation of renal masses , measured by histopathologic          examination of the targeted tumour.        -  To determine the safety of IRE ablation of renal masses, by evaluating device and          procedural adverse events.      Secondary Objectives:        -  To evaluate the efficacy of MRI in the imaging of ablation success, extend of the          ablation zone, one and four weeks post IRE ablation.        -  To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the          ablation zone, one and four weeks post IRE ablation.      Population:      10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for     radical nephrectomy.      Intervention:      Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical     nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS     imaging. After radical nephrectomy histopathological examination will be performed to     evaluate IRE ablation success.   "
75421|NCT02298595|"     This study evaluates the combination of BYL719, cisplatin and cetuximab as induction     chemotherapy prior to minimally-invasive transoral surgery (TORS or TLM) and selective lymph     node dissection (SLND), followed by risk-adapted intensity-modulated radiation therapy (IMRT)     in patients with transorally resectable, Stage III-IVa, HPV-associated oropharyngeal squamous     cell carcinoma (OPSCC).   "
75429|NCT02298491|"     The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the     improvement and long-term stabilization of clinical and radiographic abnormalities that occur     in patients with CNS sarcoidosis. In addition, it will also look at whether treatment will be     also associated with improvement in measures of quality of life. The treatment of CNS     sarcoidosis involves the use of either corticosteroids such as prednisone or potent     immunosuppressive agents such as methotrexate, both which can induce severe long term side     effects. The adverse effects of steroids may be avoided by treatment with adrenocorticotropic     hormone (ACTH), which is available for patient use as H.P. Acthar® Gel. The efficacies of     H.P. Acthar® Gel in the treatment of CNS sarcoidosis and the impact on quality of life have     not been previously studied. In addition, little is known regarding the expression of immune     markers in CNS sarcoidosis and the association of such markers with disease activity and     response to treatment.   "
75430|NCT02298478|"     The purpose of this study is to determine the efficacy of a computer-aided self-help     treatment for flying phobia with or without support by the therapist, compared to a waiting     list control group.      Secondary objectives: a) to explore two ways of delivering NO-FEAR Airlines, with or without     therapist guidance and b) to study the patients' acceptability through expectations,     preferences and satisfaction towards the online program. In this work, we present the study     design.      The principal hypothesis is that the two intervention groups will improve significantly     compared to the waiting list control group.   "
75431|NCT02298465|"     Extracorporeal shockwave lithotripsy (ESWL) for urinary stone is common and widespread     nowadays. Approximately 80% of urinary stones are treated by ESWL. Traditionally distal     ureteric stones are treated with ESWL in the prone position. However, as some patients cannot     tolerate lying in the prone due to medical illness such as chronic obstructive pulmonary     disease (COPD), some authors have reported using the supine approach of ESWL for treatment of     distal ureter stones. No serious complications had developed in the patients who underwent     supine approach. Only minor complications such as self-limiting blood in the urine, painful     passage of urine, or local pain that had responded to oral painkillers. There were no serious     complications encountered in children as well. In the most recent retrospective review by     Tolley et al, they had revealed that patients who had underwent supine ESWL for distal     ureteric stones had an improved stone-free rate compared with the traditional prone approach.      Patient with radio-opaque distal ureteric stones (stones below the sacroiliac joint) on KUB     X-ray, who have opted for ESWL treatment, are randomized into two groups: one undergoing ESWL     in the supine position and the other undergoing ESWL in the prone position. Patients will be     observed for two hours after ESWL before being discharged. Oral painkillers as necessary will     be provided to the patient. The patients will have a KUB Xray at 2 weeks post-ESWL, and then     monthly afterwards if required. If there are residual stones at the 2-week follow-up, the     patient will be offered ESWL again. Patients are free to withdraw from the study at any time     and will continue to be managed as per usual.      The investigators aim to have 130 patients, with 65 patients in each group with an interim     analyses to be performed when 66 patients have been recruited (33 patients in each group).   "
75432|NCT02298452|"     The reason for this study is to evaluate a new hearing aid product generation replacing the     one on the market. The goal is to evaluate the audiological performance, usability as well as     features and functions.   "
75433|NCT02298439|"     The purpose of the Non-Alcoholic Fatty Liver Disease (NAFLD) registry is to collect     demographic and clinical data on patients being treated for NAFLD and to determine the     factors affecting the progression of the disease as well as the success of different     treatment strategies.   "
75434|NCT02298426|"     This study aims to explore the effectiveness of body constitution classification based     comprehensive health management intervention on obese population.   "
75435|NCT02298413|"     The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb     BVS implantation in a real world, all-comers population of consecutive patients, as treated     according to the indications, techniques and protocols used in the participating     institutions.   "
75436|NCT02298400|"     The purpose of this study is to compare the comfort of three commercially available contact     lenses.   "
75437|NCT02298387|"     This is an open-label Phase 1 dose escalation and expansion study of OMP-305B83 in subjects     with previously treated solid tumors. Study includes a dose escalation phase and expansion     phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers,     and efficacy.   "
75438|NCT02298374|"     The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder     persons who receive homecare services, but still are relatively independent in most     activities of daily living. The model focuses on early identification of decline in function     and intervention in the home environment through close cooperation between the participant,     homecare services and therapists.   "
75461|NCT02298075|"     The primary objective of the study is the evaluation of sustained response rate after     discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or     chronic pITP patients who failed one or more therapy lines, splenectomy included.   "
75462|NCT02298062|"     The objective of this study is to investigate the effect of infliximab to the children who     don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki     disease.   "
75439|NCT02298361|"     Health insurance is important for children. Public insurance programs are available to many     children, but some families report being confused about how to get and keep this insurance.     Community Health Centers (CHCs) can help families get and keep health insurance for their     children.      The investigators will work with families, policy makers, and community health care providers     and staff to develop and test new computer health information technology (IT) tools to help     health care clinics find pediatric patients in need of insurance and communicate with their     families about public insurance programs. These tools will be based on technologies currently     used to help patients and clinics manage chronic diseases. The investigators will test the     tools by comparing four clinics using the tools and four clinics not using the tools. The     investigators will look to see if children in the clinics using the tools are more likely to     have health insurance and also more likely to receive certain health care services, compared     to children in the clinics without such tools. The investigators will also look at health     insurance rates and health care services for a larger population of Oregon children.   "
75440|NCT02298348|"     This study will combine three drugs: sorafenib, cyclophosphamide and topotecan.      Adding sorafenib to cyclophosphamide and topotecan may increase the effectiveness of this     combination. The investigators first need to find out the highest dose of sorafenib that can     be given safely together with cyclophosphamide and topotecan. This is the first study to test     giving these three drugs together and will help determine the highest dose of sorafenib that     can safely be given together with cyclophosphamide and topotecan to patients with     resistant/relapsed neuroblastoma.   "
75441|NCT02298335|"     This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol     (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of     adult idiopathic nephrotic syndrome.   "
75442|NCT02298322|"     Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using     Cryolipolysis. Healthy adult men and women with submental skin fold thickness > 1cm who     desire reduction of submental fat.   "
75444|NCT02298296|"     The purpose of the study is to to determine the natural history of positive psychological     states, health status, and functioning, over an 8 week period following admission for an     acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline     to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention     trial (NCT02004158).   "
75445|NCT02298283|"     This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in     patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity     after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).   "
75446|NCT02298270|"     This study tests the efficacy of an 8-week, Skype-based, group resiliency training     intervention (The Relaxation Response Resiliency Program) for improving psychological stress     in patients with Neurofibromatosis. A control group will receive a general health education     curriculum. The investigators hypothesize that patients will improve on measures of     psychological stress as a result of the resiliency program.      A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a     sub-population: patients with NF2 who are hard of hearing.   "
75447|NCT02298257|"     This phase II trial studies the side effects and the best dose of brentuximab vedotin and     combination chemotherapy work in treating patients with stage III-IV human immunodeficiency     virus (HIV)-associated Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin,     can block cancer growth by finding cancer cells and causing them to die. Drugs used in     chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving brentuximab vedotin together with combination     chemotherapy may kill more cancer cells.   "
75448|NCT02298244|"     Some patients with a long history of AF develops PH reactive type with an increase in     pulmonary vascular resistance due to vasoconstriction or structural changes of the vascular     wall. RFA PVI + RFA GP is the gold standard in the treatment of patients with persistent     AF, do not respond to optimal therapy. The rear area of the pulmonary artery bifurcation is     adjacent to the roof and part of the front of the left atrium. In the projection of this area     are ganglionic plexus of the left atrium, the sympathetic nerve fibers of the pulmonary     artery and baroreceptors main pulmonary artery.Recent studies have shown that radiofrequency     denervation of the pulmonary artery improves the quality of life in patients with PH.   "
75449|NCT02298231|"     This research study evaluates the effectiveness of a low-cost Virtual Reality-based (VR)     training system in providing a customized balance treatment in a skilled clinical setting.     Participants will be assigned to one of three treatment groups.   "
75450|NCT02298218|"     In this clinical study, meloxicam will be used to the patients who are older than 2 years and     underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after the     medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver     stiffness scores will be compared before and after the medication of meloxicam, and the roll     of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their     hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug,     meloxicam is safe medicine which is used to treat pain or inflammation caused by     osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old.     It may also be used for purposes not listed in the medication guide. It will be taken once a     daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group).     After 6 months of medication, the maintenance will be decided by the comparison of liver     stiffness score before and after the intervention.   "
75463|NCT02298049|"     To our knowledge no study has assessed the effects of a meal on neural responses to food cues     and compared this with a condition simulating natural inter-meal hunger levels. This is     important, as the existing literature often compares the effect of fasting to satiation,     which may not reflect typical appetite processes. Thus, the purpose of this research was to     examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen     level dependent (BOLD) activity in the human brain, as measured using functional magnetic     resonance imaging (fMRI).   "
78716|NCT02255513|"     This study will examine the efficacy and safety of HLD200 (methylphenidate) in patients age     6-12 years with ADHD. This study has a 6-week dose optimization period followed by a one week     double blind randomization assessment.   "
75451|NCT02298205|"     African American (AA) children carry a disproportionate burden of mortality and morbidity in     asthma. A major contributor to racial disparity in asthma is lack of adherence to     guideline-recommended use of daily inhaled corticosteroids (ICS). Symptom-based adjustment     (SBA) of ICS is a recently described patient-centered approach to asthma therapy in which     patients adjust their ICS on a day-to-day basis guided by their symptoms. The overall goal of     our study is to identify an acceptable, pragmatic and effective approach to asthma management     in high-risk AA children. Our primary hypotheses are that SBA of ICS use is more acceptable     than provider-based adjustment (PBA), equally effective in improving pediatric asthma     outcomes, and will reduce the cumulative dose of ICS needed for asthma control. Therefore, in     the Asthma Symptom based adjustment of Inhaled Steroid Therapy in African American children     (ASIST) study, we propose a randomized, open-label, 2-arm, parallel, pragmatic trial in which     we will randomly assign 200 AA children to either receive SBA or PBA for 12 months. The     primary outcome is asthma control as measured by the Asthma Control Test (ACT). We propose     that asthma control in the SBA group will be equivalent to the PBA group after 12 months.     Secondary outcomes include monthly cumulative ICS dose, exacerbation rate, quality of life,     lung function, adherence and satisfaction with the treatment plan.   "
75452|NCT02298192|"     This trial is conducted in Europe, North America and the United States of America.      The aim of this trial is to compare two different titration algorithms of insulin     degludec/liraglutide.   "
75453|NCT02298179|"     The purpose of this study is to evaluate the safety and immunogenicity of two doses of the     investigational RSV F subunit vaccine administered intramuscularly (IM). In this current     Phase 1, first-in-human study, the three different antigen amounts that have been selected     will be evaluated in a stepwise manner in three different cohorts (cohort 1: low dosage of     RSV F subunit vaccine, cohort 2: middle dosage of RSV F subunit vaccine, and cohort 3: high     dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum     hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be     evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels   "
75466|NCT02298010|"     The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose     stations and the relation between each metastasis and survival are to be analyzed by     retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229)     which have compared adjuvant chemotherapy and no adjuvant therapy after radical gastrectomy     with extended lymphadenectomy.   "
75467|NCT02297997|"     This study is to assess the impact on the prevention of sarcopenia after taking     cetylpyridinium chloride targeting the patients of presarcopenia over the age of 60.   "
75454|NCT02298166|"     The main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center     trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation     as defined in the inclusion /exclusion criteria.      An initial open label dose-finding run-in phase I of the study will be performed     administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone     and cytarabine (MC) in 18 patients according to the experimental arm of the study. After     completion of this dose-finding run-in phase I, toxicity and response data will be provided     to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the     Coordinating Investigator. The Trial Committee will decide on the basis of these data and the     recommendation of the DSMB on dose modification and the further conduct of the study with     regard to the double-blinded, placebo-controlled, randomized phase of the study.      The double-blinded, placebo-controlled randomized portion will start after the completion of     the dose-finding run-in phase I and positive opinion of the Trial Committee.      Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next     chemotherapy; if receiving allogeneic HCT, crenolanib is held 48 hours prior to conditioning     and restarts no sooner than 30 days and not later than day 100 after transplant.      Sample size randomized phase: 276 patients      Primary objective: To evaluate the impact of crenolanib given in combination with salvage     chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and     ongoing single agent maintenance therapy with crenolanib on event-free (EFS) and overall     survival (OS) in adult patients with relapsed or refractory AML harboring FLT3 activating     mutations.   "
75455|NCT02298153|"     This study will evaluate the safety and tolerability of epacadostat (INCB024360) administered     in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic     non-small cell lung cancer (NSCLC) that have been previously treated with platinum-based     chemotherapy and Stage IV urothelial carcinoma who have failed a platinum-based chemotherapy     regimen. The study will be conducted in two phases. The dose escalation phase will utilize a     3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose     (PAD) of the combination. This will be followed by a dose expansion phase, which will be     comprised of three cohorts. Expansion Cohorts 1 & 2 will further evaluate the safety,     tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in     phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following     treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab     administered in combination.   "
75456|NCT02298140|"     INDEPTH Network Effectiveness and Safety Studies in Africa (INESS) have demonstrated a     substantial efficacy decay of Artemisinin based combination therapy (ACT) in Tanzania in 2012     (from efficacy of 98% to effectiveness of 18%). Hence system readiness for control and     elimination strategies is severely compromised. Sub-optimal health workers' performance in     treating malaria cases was a major contributor to the decay, effecting both treatment and     patient adherence. If these quantified system failures remain unchecked it will pose major     barrier in achieving malaria control and elimination goals. There is growing evidence that     mobile phone text message reminders can improve health workers' compliance and patients'     adherence to malaria treatment guidelines. Tanzania has recently harnessed all public sector     health worker phones into Short Message System (SMS) platform. The investigators intend to     exploit this opportunity in a randomized trial of messages to substantially reduce the decay     documented by the INESS platform.      The null hypothesis: Sending automated text message reminders to health workers on malaria     diagnosis and treatment recommendations, will not have any effects in the quality of malaria     case management.   "
75464|NCT02298036|"     To determine the cost and clinical effectiveness of offering 6-10 sessions of remotely     delivered cognitive behaviour therapy (CBT) via video calling or over the telephone for     health anxiety in repeated utilisers of unscheduled/urgent care versus treatment as usual.      To optimise the delivery of CBT for health anxiety delivered remotely by systematically     identifying and then acting on barriers and enablers to the intervention through a network of     practice.   "
75465|NCT02298023|"     Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal     stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with     supraspinatus partial thickness tear by ultrasonographic guided injection.   "
75468|NCT02297984|"     Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and     therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible     factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is     increased in brain after acute cerebral infarction in humans and experimental animals.The     investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in     patients with acute ischemic stroke during the initial 96-h period after stroke and assessed     the relation between them and the relation of them to prognosis of such patients with acute     ischemic stroke.   "
75469|NCT02297971|"     When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of     bleeding when it is continued peri-operatively have to be weighed against the risk of     coronary artery thrombosis when stopped. This study aims to assess coagulation and     thrombocyte function every other day in patients who are taking ticagrelor after coronary     artery stents and discontinue therapy at the end of one year.   "
75470|NCT02297958|"     Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many     patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for     induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell     motility.   "
75471|NCT02297945|"     The purpose of this prospective, international phase III/IV study is to assess the efficacy     and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36 weeks     of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free cortisol     (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.   "
75472|NCT02297932|"     Physical activity and exercise interventions in multiple sclerosis (MS) have received great     attention most recently and there exists several randomized clinical trials (RCTs) addressing     the outcomes associated with such intervention. The majority of such interventions have     primarily focused on directly influencing disease processes (e.g., inflammation, neurotrophic     factors), the reduction of symptoms (e.g., fatigue, depression), improvement in physical     functioning (e.g., gait, strength) or enhancing one's quality of life. To date, the evidence     suggests that exercise intervention in MS holds anywhere from minimal to great promise     depending on the outcome of interest. For some outcomes such as depression or cognition,     findings are even less optimistic, being null, or inconsistent, at best. These inconsistent     findings may be attributed to methodological issues such as use of subjective reports, lack     of appropriate control group, poor compliance, and sample selection. The proposed     investigation aims to address some of these issues by: (1) Obtaining objective measures of     outcomes of interest (i.e., fatigue, cognition, and participation/activities of daily living     [ADLs]) and; (2) assessing certain person-specific factors (e.g., personality) and     intermediary factors that may be influenced by physical activity and indirectly result in     improved outcomes (e.g., improvement in sleep and subsequent improvement in fatigue and/or     cognition). Thus, the primary objective of the proposed investigation is to: (1) utilize     innovative and objective measures of outcomes and; (2) obtain comprehensive assessment of     intermediary variables (e.g., sleep) or person-specific characteristics (e.g., personality),     which together may explain the inconsistent findings in the literature and has the following     specific aims:      To achieve these goals, individuals will complete a comprehensive assessment of cognition,     person-specific factors, intermediary factors, physical fitness, and functional magnetic     resonance imaging (fMRI) prior to and following a home based exercise intervention.   "
75473|NCT02297919|"     The purpose of this study to create an educational portal Genç (e) sağlık in an attempt to     develop a healthy eating habit, increase physical activity and reduce sedentary behavior in     order to prevent to overweight gain which is school-based approach in adolescents and there     with also test the level of program information and the behavioral alterations of     effectiveness.   "
75474|NCT02297906|"     Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both     adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic     purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal     atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when administered     by the IN route using the MAD.   "
75475|NCT02297893|"     Background and aim: Patients with Parkinson's disease (PD) exhibit disturbed manual     dexterity. This impairment leads to difficulties in activities of daily living (ADL) such as     buttoning a T-shirt or hand-writing. The aim of the present research project is to     investigate the effectiveness of a high intensity home based exercise intervention focusing     on fine motor skills (HOMEDEXT), in patients with PD.      Design: A single blinded randomized controlled trial (RCT) will be performed. Randomization     will be done by an independent biostatistician who will use a computerized randomization     protocol. A baseline assessment and a follow-up measurement 4 weeks immediately after     intervention (end of rehabilitation) will be performed. A follow-up measurement, 12 weeks     later, will be done to assess long-lasting effects. Assessments will be performed by     investigators who are blinded for the intervention.      Participants: One hundred and four out-patients with PD will be recruited who report specific     difficulties in manual dexterity when executing ADL. Intervention: The patients will be     allocated to either an intervention group (n = 52) or control group (n = 52). In the     intervention group PD patients will exercise, over a period of four weeks, once/day during 30     minutes a treatment with specific exercises for dexterity. The PD patients, who will be     allocated to the control group, will exercise Theraband exercises.      Outcome measures: The primary outcome measures for manual dexterity will be the Nine Hole Peg     test. Secondary outcome measures will be the Coin Rotation task, a sensitive screening for     dexterity. Furthermore for ADL a modified version of the subscale II of the Movement     Disorders Society unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used.     Parkinsonian symptoms will be assessed by the MDS-UPDRS subscale III. To assess improvements     in quality of life a modified version of the Parkinson's Disease Questionnaire (PDQ-39) will     be used.   "
75476|NCT02297880|"     Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or     appetite, divergent opinions appear regularly both in the scientific literature and in the     popular press. The goal of this study is to examine the effects of LCS containing beverages     on appetite and intake in healthy individuals.   "
75477|NCT02297867|"     The aim of the investigators study was to investigate the safety and efficacy of autologous     ADSCs for the clinical treatment of liver cirrhosis.   "
75478|NCT02297854|"     This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's     Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA     Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fasting     conditions.   "
75479|NCT02297841|"     Determine the ability of the study material (personal lubricant) to cause sensitization by     repeated topical application to the skin of humans under controlled patch test conditions.   "
75483|NCT02297789|"     Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective     of this clinical investigation is to evaluate the usability and acceptance of the     investigative mask, the effectiveness of the seal and headgear.      The participant will be randomised to use either full face mask prototype 1 or 2 as according     to the randomization log for 7 ± 3 days in home. The participant will then crossover to the     other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or     the participants will be blinded to the study.   "
75484|NCT02297776|"     Prediction of clinical outcome after cardiac arrest is clinically important.Early     prognostication after successful cardiopulmonary resuscitation is difficult, and there is a     need for novel methods to estimate the extent of brain injury and predict outcome. In this     study, the investigators will evaluate the plasma levels of microRNAs (miRNAs) and circRNAs     after cardiac arrest and assessed their ability to prognosticate neurological outcome.   "
75485|NCT02297763|"     The purpose of this study is to evaluate the efficacy of low dose quetiapine for the     prophylaxis of delirium in critically ill patients in medical intensive care unit.   "
75486|NCT02297750|"     The purpose of this study is to give doctors who perform Endoscopic Retrograde     Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in     order to examine the bile duct as quickly and safely as possible.   "
75487|NCT02297737|"     This study evaluates the feasibility and acceptability of a 12-week Tai Chi intervention for     patients who have recently had a heart attack and are not participating in a standard cardiac     rehabilitation program. Half of the 75 patients will be randomly assigned to the Tai Chi     condition and the other half will be assigned to 12 weeks of Health Education. In addition to     examining feasibility and acceptability, the investigators will evaluate the impact of     participation in the Tai Chi condition on measures of cardiac health, physical function,     self-reported health behaviors, and mental health as compared to Health Education within the     context of this developmental/exploratory study.   "
75488|NCT02297724|"     The ultimate goal of this project is to develop methods that allow informed decision-making     on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In     placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies.     Although there is no specific correspondence between a single type of pathology and IUGR, the     common result of these pathologies is placental insufficiency, which limits the     maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR     placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and     inflammation in the villous and intervillous space (villitis). Thus one potential approach to     distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental     transport. Based on the hypothesis that efficiency of oxygen transport is representative for     overall oxygen and nutrition transport in placenta, the investigators propose to characterize     the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use it as an index     for better stratification in the IUGR risk group. The investigators will also consider     alternative MRI approaches such as structural, diffusion and spectroscopy measurements inside     the placenta, which might reflect the state of placental transport and reveal the status of     placental health.      Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency     from normal placenta transport with histopathology data of the placenta. 2) To correlate the     MRI metrics that reflects placental insufficiency with fetal outcome   "
75489|NCT02297711|"     Sportsman's hernia is defined as a weakness or disruption of the posterior wall of the     inguinal canal. Open hernia repair with or without mesh or laparoscopic techniques with mesh     have been advocated in the treatment of sportsman's hernia and associated athletic pubalgia.     The results of the operative treatment from single centers are reported to be good to     excellent in between 70 - 90% of patients with the most promising results reported using an     open minimal repair (OMR) technique. There are no randomized trials comparing open versus     laparoscopic techniques regarding time for recovery and relief of pain. The aim of this     randomized study is to compare the effectiveness of OMR technique in local or spinal     anesthesia to endoscopic Total ExtraPeritoneal (TEP) technique in general anesthesia for the     treatment of Sportsman´s hernia/athletic pubalgia. The primary endpoint is patient being free     from intractable groin pain during sports activity or daily work four weeks after surgery.   "
75490|NCT02297698|"     This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled     phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone. Our     target study population is high-risk HER2-positive breast cancer patients. High-risk     HER2-positive breast cancer patients are defined as:      Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive     neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four     cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR.      Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo     surgery as a first intervention and are found to have ≥ 4 positive lymph nodes.      Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a     first intervention and are found to have 1-3 positive lymph nodes.      Disease-free subjects after standard of care multi-modality therapy will be screened and     HLA-typed.   "
75491|NCT02297685|"     Objective: The aim of this investigation was compare the effectiveness of transcutaneous     electrical nerve stimulation (TENS) and interferential currents (IC) on chronic low back     pain. Forty-eight patients diagnosed as having chronic low back pain were randomly assigned     to three groups: control (sham electrotherapy; age 47 ± 8 years), interferential currents     (IC; age 48 ± 8 years) and transcutaneous electrical nerve stimulation (TENS; age 48 ± 8     years). Patients in all groups received 12 × 30-min sessions of the assigned treatment for a     period of 4 weeks plus therapeutic exercises. Before and after the treatment, low back pain     was measured using a 100-mm visual analogue scale and functional disability level was     measured using the Rolland Morris Disability Questionnaire. Participants status was followed     up 3 months after the end of the treatment.   "
75492|NCT02297672|"     Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well     tolerated form of partial breast radiotherapy. This protocol aims to build on the initial     experience and to further refine the technique and collect toxicity and cost data, especially     in comparison to alternate forms of breast radiotherapy.   "
75493|NCT02297659|"     Damage control laparotomy (DCL) has proven to be a successful means to improve survival in     severely injured patients.1-5 However, the consequences of not being able to close the fascia     after the initial operation due to significant resuscitation leading to bowel and     retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy     and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC)     contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias,     enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use     after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing     for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or     standard crystalloid solutions after DCL and compare the time to PFC, rate of successful     closure, and rate of complications associated with an open abdomen. The current failure rate     of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using     hypertonic saline.   "
75494|NCT02297646|"     The purpose of this study is to investigate the effects of carbohydrate intake on training     efficacy and health parameters of an endurance training program in healthy adults.   "
75495|NCT02297633|"     This study through the long-term observation followed up for 2 years to find the change of     the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the     severity of COPD. Evaluate the differences of prognosis between the different oxidative     stress level (according to the level of ROMs are divided into higher and normal phenotype).     Explore the new oxidative stress evaluation index ROMs application value in COPD.   "
75496|NCT02297620|"     The objective of this survey is to confirm the safety of Suglat Tablets when used in the     elderly.   "
75497|NCT02297607|"     Patients undergoing an esophagectomy will be randomized to receive either (1) routine     post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube     feeding to continue in the hospital until the patient is taking adequate nutrition by mouth     at POD#8, or upon discharge.      Specific Aim 1 is to determine the occurrence of common complications and readmissions     post-operatively between the two patient groups. The investigators hypothesize that routine     use of tube feeding may reduce the occurrence of post-operative complications.      Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects     recovery and QOL after esophagectomy. The investigators hypothesize that routine     post-operative supplementation will enhance patients recovery and QOL.      For esophagectomy specifically, there is very limited literature evaluating the complication     rate and QOL associated with the length of post-operative tube feeding and adequate     nutritional requirements. Small randomized studies have not shown a benefit to routine tube     feeding, although the numbers were very small, ranging from 12-70 per group. The     investigators will randomize 200 patients for the purpose of this study.   "
75498|NCT02297594|"     The purpose of this study is to assess the safety, tolerability and PK of single and multiple     ascending dose of AK0529 when administered orally in healthy subjects   "
75499|NCT02297581|"     The study will assess patients with at least one major AE related to treatment /     hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the     usual care group.   "
75500|NCT02297568|"     This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to     determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin     D status of breastfed infant.   "
75501|NCT02297555|"     Obesity and metabolic syndrome (MS) are closely interrelated leading to increased mortality,     mainly due to cardiovascular disease. In addition, some cancers are much higher when obesity     is associated with metabolic syndrome. Bariatric surgery allows significant and sustained     weight loss with marked improvement of MS. Considered too invasive, surgery is proposed to a     small proportion of patients who could theoretically benefit. The ENDOBARRIER® device     implanted endoscopically is an innovative approach developed for management of obesity in the     non-surgical manner with benefits for improvement in MS already reported in literature.   "
75502|NCT02297542|"     This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a     high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define     the key determinants of vaccine-mediated protection against influenza and how these     immunologic mediators may be enhanced by vaccination with a newly approved high-dose     influenza vaccine in older people   "
75503|NCT02297529|"     The study is a phase 3b, multicenter, open-label, single-arm study designed to provide     expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected     stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of     Talimogene Laherparepvec.   "
75504|NCT02297516|"     The efficacy and safety, as well as subject satisfaction will be evaluated after single     treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated     combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster.     Subjects will be followed for up to 18 months after initial treatment.   "
75505|NCT02297503|"     The efficacy and safety, as well as subject satisfaction will be evaluated after single     treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined     treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be     followed for up to 18 months after initial treatment.   "
75506|NCT02297490|"     The study will explore how allergy symptoms experienced during the grass pollen season     compare to symptoms experienced in the Environmental Exposure Chamber (EEC).      There are 2 treatments in this study. Both treatments are injected under the skin.     Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before     the grass pollen season begins which may lead to decreased sensitivity and reduced allergy     symptoms during the grass season. Placebo treatment does not contain grass pollen mixture,     and is not expected to reduce allergic symptoms overtime.   "
75560|NCT02296775|"     This study will compare the plasma pharmacokinetic profile and the change in disease activity     score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses     of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be     monitored for safety, B cell depletion and recovery, and for the development of immune     responses to the administered study drugs   "
75507|NCT02297477|"     This is a two-arm, randomized, open label Treatment Study evaluating the therapeutic     efficacy, safety, tolerability and pharmacokinetics of a three-day course of     Atovaquone-Proguanil (AP) or a three-day course of Atovaquone-Proguanil combined with 3 days     of Artesunate (ASAP) in patients with uncomplicated Plasmodium falciparum malaria at selected     sites in Cambodia. Atovaquone-proguanil, soon to adopted as a first line antimalarial agent     by the National Malaria Control Program (CNM) in Cambodia in provinces with confirmed     multidrug resistance, will be given with or without artesunate (AS) as a directly observed,     standard three-day fixed dose combination treatment to all volunteers enrolled. The efficacy     and safety of both drug combination as well as evidence for in vivo and in vitro resistance     to their components will be monitored during the treatment period. All volunteers will     receive a single dose of 15mg of primaquine as recommended by WHO with the first dose of AP     or ASAP to block the transmission of malaria to mosquitoes. Resistance to AP and ASAP will be     assessed by a combination of clinical, pharmacologic, and parasitological parameters     including genomic signatures of selection during careful weekly follow-up visits for 6 weeks.     Investigators will also be able to evaluate the effects of primaquine on the sexual stages of     malaria (gametocytes).   "
75508|NCT02297464|"     Contrary to popular belief, previous studies have demonstrated beneficial effects of whole     egg consumption in modifying biomarkers indicative of a greater risk of coronary heart     disease (CHD), chronic inflammation, and insulin resistance. The following study is designed     to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an     oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin     sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that     the consumption of 2 eggs per day will not negatively impact plasma lipids in a young,     healthy population.   "
75509|NCT02297451|"     Background:      Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is     normally created at the level of the wrist, but occasionally it is created in the elbow when     there is no suitable vessel in the forearm. The most common type of elbow (antecubital)     fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal     syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using     proximal radial or ulnar artery as inflow has been described and shown to have a lower rate     of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence     of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar     artery as inflow.   "
75510|NCT02297438|"     The study is designed to compare the clinical benefit following treatment with letrozole in     combination with Palbociclib versus letrozole in combination with placebo in Asian     postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior     systemic anti cancer therapies for their advanced/metastatic disease.   "
75511|NCT02297425|"     Phase 1 - open label, multi-center, non-randomized, safety, pharmacokinetic and     pharmacodynamics dose escalation study of PF-06459988 as a single agent in patients with     advance EGFRm NSCLC (del 19, L858R, +/- T790M). The resulting PF-06459988 dose selected from     the phase 1 portion will undergo a series of sub-studies to fully characterize the impact of     food, antacid and CYP3A4 inhibitors/inducers. The PK studies are in addition to the MTD     expansion and will be completed prior to the initiation of Phase 2. Phase 2 is an open label,     multi-center single-arm study of PF-06459988 for the assessment of antitumor activity in     patients with advanced EGFRm (del 19 or L858R) NSCLC with T790M.   "
75512|NCT02297412|"     This randomized pilot trial studies how well minocycline hydrochloride works in reducing     chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer     undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may     cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and     toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the     quality of life in breast cancer patients.   "
75513|NCT02297399|"     This trial will compare the tolerance to 2 different methods for colon cleansing before     colonoscopy in diabetic patients.   "
75514|NCT02297386|"     The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT     (stands for [18F] Dihydro-Testosterone), to better find and monitor prostate cancer.     Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen     by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in almost     all prostate cancer cells. The investigators want to find out if we can find and monitor     changes in cancer using a FDHT PET scan.   "
75515|NCT02297373|"     Patients with a history of blood clots are at risk of developing additional clots in the     future. Doctors use a tool called a clinical decision rule to tell them how likely it is that     a patient has a blood clot and if they should have further testing to look for the clot. This     tool may cause doctors to over-diagnosis a recurrent clot because the symptoms may be left     over from the previous clot. Correctly diagnosing a recurrent blood clot is very important     since there are risks associated with both over-diagnosis and under-diagnosis. If a recurrent     blood clot is missed (under-diagnosis) the patient is at risk of death from a clot in the     lungs. If blood thinners are prescribed when they are not needed (over-diagnosis), the     patient may have to take blood thinners for their lifetime and risk having serious bleeding.   "
75516|NCT02297360|"     The Viviscal Extra-Strength formulation is an oral food/dietary supplement specifically     designed to promote hair growth for women suffering from temporary thinning hair. It does not     contain hormones or drugs and has been marketed in Europe for over 15 years. Viviscal     Extra-Strength is marketed as Viviscal Maximum Strength in some other territories.      The hypothesis of this clinical research study is that the ingestion of Viviscal     Extra-Strength over a three (3) month period will strengthen and promote the growth of     terminal hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair     associated with poor diet, stress, hormonal influences or abnormal menstrual cycles when     compared to using the placebo tablet.   "
75561|NCT02296762|"     This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India     and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,     adult,human subjects under Fed conditions.   "
75562|NCT02296749|"     This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India     and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,     adult,human subjects under Fasting conditions.   "
75517|NCT02297347|"     Newborn screening and early treatment prevent the most severe manifestations of     phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder,     slow processing speed, and visual-motor problems commonly occur. Many adults with this     disorder also suffer depression and anxiety. In this study the investigators will examine     adults with PKU on sapropterin dihydrochloride (Kuvan) treatment for PKU and compare their     results to those of subjects with PKU not on Kuvan. Using magnetic resonance imaging (MRI)     techniques, including novel MR spectroscopy (MRS) the investigators hope to discover why this     distinct constellation of deficits occurs in PKU. Adult subjects with PKU will undergo a     comprehensive MRI evaluations, including a novel method of MR spectroscopy to determine brain     phenylalanine levels. In addition, participants will receive neurological and     neuropsychological examinations and dietary evaluation.   "
75518|NCT02297334|"     The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary     circuit attenuates the inflammatory response to extracorporeal circulation in patients     undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood by     the CytoSorb device significantly improves circulation and outcome in patients undergoing     on-pump cardiac surgery.   "
75519|NCT02297321|"     This is a prospective study to evaluate the efficacy and safety of an accessory for laser     tattoo removal in allowing multiple passes within a single treatment session.   "
75520|NCT02297308|"     This study is a retrospective, single center data collection to assess bleeding and vascular     complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral     Introducer is used for vascular access.   "
75521|NCT02297295|"     The purpose of this study is to determine whether exercise medicine in lower limb amputees     has a impact on the three domains of the International Classification of Functioning of the     WHO (function, activities and participation), and on quality of life.   "
75522|NCT02297282|"     Depression affects 15% of Canadians resulting in serious impact on health, ability to     function including social, family and work related activities. Despite the several treatment     options available for managing depression including medications, many patients do not respond     to treatment and experience troublesome side effects. Psychotherapies are important in the     treatment of depression and several options are currently being offered at the Mood Disorders     Program (MDP), St. Joseph's Healthcare Hamilton. However a simple and reportedly effective     therapy called Behavioural Activation (BA) is not currently available and existing evidence     supporting its' effectiveness is limited to individual therapy of community based patients     who are unlike the patients seen at the MDP who may have a more severe illness. The     investigators are therefore planning to study the effectiveness of BA in patients with     depression as an add on therapy to existing usual care compared to wait-list added to usual     care. The study outcome is reduction in depressive symptoms and improvement in quality of     life. The duration of therapy is 18 weeks and all adults with depression are eligible to     participate.   "
75523|NCT02297269|"     Deep vein thrombosis (DVT) is a common complication of surgery, which could result in     pulmonary embolism (PE). PE is a serious and potentially life-threatening syndrome. The     purpose of this study is to investigate the impact of laparoscopic versus open surgeries on     the incidence of postoperative DVT in patients with gastrointestinal malignancy   "
75524|NCT02297256|"     This study is a single-center, prospective randomized clinical study intended to compare and     evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate     (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral     spinal fusion.   "
75525|NCT02297243|"     The purpose of this study is to collect preliminary clinical data related to the safety and     performance of the Sinopsys Lacrimal Stent.   "
75526|NCT02297230|"     Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and     Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast,     supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the     primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until     surgery and as per standard of care after surgery for up to 1 year total.      **Surgery: Patients will undergo lumpectomy and axillary node dissection or modified radical     mastectomy within two months following discontinuation of pre-operative systemic therapy,     contingent upon recovery of skin toxicity. Pathologic response will be evaluated at the time     of surgery. Additional tissue samples will be collected from the surgical specimen for     assessment of tumor molecular characteristics.      ***All patients may undergo four cycles of post-operative Standard AC (doxorubicin 60 mg/m2,     cyclophosphamide 600 mg/m2) or four cycles of post-operative epirubicin and Cyclophosphamide     (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) if doxorubicin is not available Tamoxifen     as well or any alternative antihormonal therapy may be prescribed for five years for patients     with hormone receptor positive tumors. Herceptin (Trastuzumab) will be prescribed for a total     of 1 year since first dose as per standard of care.   "
75527|NCT02297217|"     This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a     palliative course of external beam radiation treatment improves both dysphagia relief and     patient quality of life in patients with unresectable esophageal cancer.   "
75528|NCT02297204|"     The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) end-point.     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on     the presence of CR-DME (Clinically Relevant-Diabetic Macular Edema). In addition, subjects     who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.   "
75529|NCT02297191|"     The purpose of the study is to determine the effectiveness of a new approach to numbing     (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on     the skin of the back.   "
75563|NCT02296736|"     Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic     head malignant tumours and to predict the resectability based on the preoperative imaging. To     achieve this, a retrospective review of the preoperative CT scans will be conducted for all     patients with pancreatic head malignancy treated at the Peninsula Hepato-Pancreatico-Biliary     (HPB) cancer unit between January 2006 till January 2014.   "
75530|NCT02297178|"     Urinary incontinences is a highly prevalent and distressing condition which has a significant     impact on health related quality of life in millions of women worldwide. Of all women with     incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor     overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the     International Continence society as Urinary urgency, with or without urge incontinence,     usually with frequency and nocturia if there is a no infection or proven pathology (Abrams     et al 2002)      Initial management of OAB and DO consists of conservative measures such as altering fluid     intake, bladder retraining and drug therapy. The next step consists of interventions such as     cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder     problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic     benefit.      The original study showed no benefit of urethral dilatation versus no dilatation at 6 months     follow up (Duckett 2007). The investigators do not know the natural history of patients with     voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what     happens to these patients symptoms over time.   "
75531|NCT02297165|"     The purpose of this study is to estimate the impact of an olfactive stimulation, in relaxing     environment, on the access at the autobiographical memories in anorexic patients.   "
75532|NCT02297152|"     The aim of study is to determine if they can produce increases in the IELT using a     masturbator in subjects with premature ejaculation, producing improvements in the quality and     satisfaction of the sexuality of the patient.   "
75534|NCT02297126|"     The INGenious trial will prospectively enroll a total of 6,000 patients, with 2,000 patients     assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed,     but not tested. It is randomized between an intervention arm and one that receives no     intervention in order that the genotyped group can be compared with one in which undisturbed,     routine clinical care is carried out in patients taking the same drugs. Both arms will be     followed for a year after being prescribed a targeted medication. Patients randomized into     the intervention arm that are prescribed one or more of the 24 targeted index medication will     receive pharmacogenomic testing using a custom micro-array measuring 51 Single nucleotide     polymorphisms in 16 genes. The study is being conducted by the Indiana University School of     Medicine and the Indiana University Institute of Personalized Medicine in collaboration with     the Eskenazi and Indiana University Health Systems and will evaluate the economic and     clinical outcomes associated with embedding a pharmacogenomics program in a system that     serves as the primary health care safety-net in Indianapolis, Indiana. By successfully     implementing a pharmacogenomics program and integrating it with the Electronic Health Record     and Clinical Decision Support system, physicians will be able to optimize patient care by     delivering tailored therapeutic decisions based on the patient's individual genetics.   "
75535|NCT02297113|"     All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department     will be screened for inclusion in this clinical study. The indication of endotracheal     intubation is an exclusively clinical decision and is not affected by this study protocol in     any aspect.      If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of     two groups        1. C-MAC Videolaryngoscope in appropriate size        2. conventional endotracheal intubation using Macintosh Blade in appropriate size      Randomization (1:1) will be based on computer-generated codes maintained in sequentially     numbered opaque envelopes that will be opened immediately before randomization.   "
75536|NCT02297100|"     The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in     interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is     a medication that comes from the bacteria Clostridium botulinum. It works by blocking the     release of the neurotransmitter acetylcholine(a chemical messenger that carries signals     between nerve cells and other cells in the body). Blocking that neurotransmitter results in     decreased muscle activity.   "
75537|NCT02297087|"     Aim 1 - Launch Pilot Study. In this aim, the investigators seek to launch a pilot study and     enroll 12 eligible patients with advanced small cell lung cancer (SCLC) and to obtain the     necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS).      Aim 2 - Treatment Selection. Completion of this study aim will provide a new clinical     paradigm in the treatment of SCLC such that each individual patient would be treated with a     single-agent or combination therapy of commercially available agents that relates to     particular target(s) that have been identified via GWS.   "
75538|NCT02297074|"     The present study was carried out to determine the glycaemic index (GI), glycaemic load (GL),     insulinaemic index (InI), appetite ratings and postprandial plasma concentrations of     gastrointestinal hormones related to the control of food intake after the ingestion of five     types of commercially available selected Spanish breads. All volunteers took the breads and     glucose in a crossover interventional study.   "
75539|NCT02297061|"     Hip fractures are associated with a large hidden blood loss. That is, the total blood loss     associated with hip fracture surgery is much greater than that observed intra operatively.     There is currently no viable method of identifying patients at risk of transfusion. The on     admission haemoglobin level has been shown to be falsely reassuring .      We are conducting a study of 200 consecutive hip fracture patients. Thrombelastography (TEG)     is taken on admission. The results are blinded to clinicians. Results will be evaluated at     the end of the study, comparing intra-operative and total blood losses with the TEG profile     of the patient.   "
75540|NCT02297048|"     Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the     urines. The investigators wonder whether progesterone or other adrenal hormon play the same     role. The investigators will investigate surrenal hormone production in healthy subjects     under a 7-day potassium depleted diet and in patients chronically hypokalaemic due to a renal     loss of potassium.   "
75564|NCT02296723|"     This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's     Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA     Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fed     conditions.   "
75826|NCT02293317|"     This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001     in thirty six (36) volunteers 50-65 years of age.      All subjects will receive an intramuscular (IM) injection, in each one of three visits, with     a 21±2 days interval between treatments.   "
75541|NCT02297035|"     Primary progressive aphasias (PPA) represent a challenging group of degenerative language     diseases that has led to growing interest in the scientific and medical community. However, a     full-blown cognitive/linguistic, anatomic and biologic characterization of the three main     variants remains incomplete given that the available data derive from relatively small     patient samples. Such a three-fold characterisation will be an major milestone with the     prospective of providing the rationale for therapeutic interventions comprising specific     rehabilitations protocols and pharmacological trials.      The present study addresses theses issues in the three PPA main variants through a     cross-sectional and longitudinal investigation exploring 1) cognitive/linguistic features, 2)     anatomic/metabolic specifications (MRI-VBM, MRI-fiber tracking, functional connectivity - MRI     resting state, PET), and 3) biologic aspects (CSF biomarkers, genetic screening).   "
75542|NCT02297022|"     The purpose of this study is to investigate the safety and efficacy of deep brain stimulation     in obese patients with Prader Willi syndrome refractory to conventional treatment.   "
75543|NCT02297009|"     A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa.     Samples will be taken from the same participant at different timepoints.      DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit     and will be quantified by a nano-drop spectrophotometer.      We will determine global and gene-specific methylation and hydroxymethylation alterations by     UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative     measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS     platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter     genes, and genes involved in the oxidative stress pathways will be assessed by     PCR-pyrosequencing.   "
75544|NCT02296996|"     Patients with BRAF V600 mutant advanced melanoma benefit from treatment with a BRAF-inhibitor     (e.g. dabrafenib, vemurafenib) and from combination of a BRAF- and MEK-inhibitor (e.g.     dabrafenib and trametinib). Following initial tumor regression, progression is diagnosed in a     majority of patients treated with BRAF-inhibitor mono-therapy within the first 12-months of     therapy. Various molecular mechanisms that underlie the development of resistance to     treatment with a BRAF-inhibitor have been reported. These mechanisms do not include secondary     mutations in the BRAF-gene and therefore resistance to BRAF-inhibition could potentially be     reversible when selective pressure by BRAF-inhibition is withheld for a sufficient period of     time of melanoma progression. This clinical trial protocol addresses the potential renewed     anti-tumor activity of combined BRAF- and MEK inhibition with the combination of dabrafenib     and trametinib in patients with unresectable AJCC stage III or - IV BRAF V600 mutant melanoma     who are documented with progression of disease at least 12 weeks following the last day of     dosing of a BRAFinhibitor containing treatment regimen.   "
75545|NCT02296983|"     Previous Ebola outbreaks have been limited to individual countries and contained by infection     control activities. The current outbreak in West Africa is international, and air travel has     resulted in a number of infected travellers crossing national borders. There are currently no     specific treatments generally available for Ebola and the mortality is high, particularly in     countries with limited intensive care facilities. There is currently no vaccine and the     personal protection required by healthcare workers treating patients is cumbersome and     requires full compliance to be protective.      There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon,     Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which     this study will be conducted. The investigators are conducting this trial, a Phase I,     open-label, dose escalation trial, designed to establish safety, tolerability and     immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first     time in sub-Saharan African populations.      The investigators plan to vaccinate 40 volunteers in Kenya. The trial will be conducted at     the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the     primary target population as they are likely to be the recipients of a protective vaccine.     The investigators will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a     further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the     vaccine. The investigators will follow them up for a period of one year looking to their     safety and immunogenicity endpoints.   "
75546|NCT02296970|"     Determine the effectiveness of a deep shave removal as a definitive treatment for basal cell     carcinoma (BCC) without the need for a follow up surgical procedure.   "
75547|NCT02296957|"     Brief Summary      Context. Sleep disorders complaints are common in elderly and hypnosedative drugs are widely     prescribed in community-dwelling elderly. Furthermore, acute hospitalisation may induce sleep     disorders and hypnosedative initiation occurs in 14 to 29% of elderly during a hospital stay.     These hospital-induced sleep disorders should spontaneously disappear after discharge and,     because of their potential impact on falls, hip fractures, psychiatric side effects and     induced dependence, hypnosedative drugs should therefore be discontinued at discharge in     these naïve-treated patients. Adhesion to this recommendation is poor. Recent and on-going     research on this topic mostly concerns adverse effects although these are already     substantially documented and evidence-based, while there is a poor interest on developing     research on potential strategies susceptible to practically improve the current adhesion to     recommendations.      Design and objectives. This project proposes multi-component intervention and is directed     towards hospital prescribers, patients, and their general practitioner. It aims at     discontinuing, at hospital discharge, the hypnosedative treatment that was initiated during     hospitalization in naïve-treated elderly (age≥65) patients. The value of the intervention, as     compared to usual care management, will be estimated in a multicentre (6 hospitals gathering     8 centres: 5 internal medicine departments, 3 cardiology departments) randomised, cross-over,     two-period trial. Two hospitals will gather 2 centres (2x2 centres) and 4 hospitals will     gather only 1 centre (4x1 centres). An equilibrated randomization will be applied to the 8     centres, making sure that, in hospitals gathering 2 centres, these 2 centres will apply the     same strategy in a given period and that the 2 hospitals will apply alternative strategies.     This randomisation is set up to avoid the risk of a potential contamination between the 2     strategies from one centre to the other within the same hospital. As a result, 3 hospitals     (including 4 medical departments) will apply the intervention during the first 11-month     period, while the 3 others (including 4 medical departments) will apply usual care during     this period, as a result of an equilibrated hospitals randomization. During the second     11-month period, each hospital will apply the alternative management. The two periods will be     separated by a 1-month wash-out period.      In all 240 patients (15 patients / centre) will be enrolled (120 in the intervention group     and 120 in the usual care group).      Patient follow-up duration will be 12 months after discharge. Patient status in regards with     quality of sleep (study primary objective), hypnosedative consumption and frequency of falls     (secondary objectives) will be collected by telephone interviews 1, 3, 6 12 months after     discharge.      Expected results. The results of the study should contribute to guide research and public     decisions to practically decrease hypnosedative prescription and consumption, and associated     adverse events.   "
75548|NCT02296944|"     This study is a retrospective cohort of patients minors during the operation of cartilage     tympanoplasty for tympanic membrane perforation   "
75565|NCT02296710|"     The investigators evaluate the changes of echocardiographic and sleep apnea parameters after     mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before     surgery. After a period of 3-5 months, they undergo a second echocardiographic and sleep     apnea control and the results are evaluated.   "
75549|NCT02296931|"     Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted     and relatively inexpensive treatment for these conditions, barriers to delivery via IV     injection in low-resource settings pose a large obstacle to reductions in mortality. AutoSyP     is a low-cost, low-powered automatic syringe pump that could overcome this barrier to the     delivery of MgSO4. We propose to conduct a pilot clinical evaluation of its ability to     deliver MgSO4 to women with pre-eclampsia or eclampsia in Malawi.      AutoSyP will be the subject of a 2 phase pilot clinical community trial in Malawi. Prior to     the start of the study, all nurses will receive a 4-hour training on AutoSyP use to ensure     proper procedures are followed. Phase 1 will be an initial validation of the clinical     performance of the device delivering only standard IV saline to 10 stable women. The study     will continue to Phase 2 where, the device will deliver MgSO4 to up to 40 women presenting     with symptoms of pre-eclampsia.        1. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP          use.        2. Eligible and willing participants will provide informed consent. Then, baseline          demographic and relevant medical history information will be collected.        3. In Phase 1, subjects will receive IV saline fluids by the Nurse. In Phase 2, the Nurse          will provide loading dose of MgSO4 with the AutoSyP and research staff will monitor and          record device performance and treatment specifications.        4. Subsequent maintenance doses of saline or MgSO4 will be administered and observations          monitored and recorded for up to 24 hours as clinically indicated.      Others may benefit from this study in the future as AutoSyP is a new delivery system is     needed to break down the barriers to IV delivery of MgSO4 in low-resource settings. The     results of this study will be made available to the Ministry of Health, NHSRC, COMREC, the     College of Medicine Library, the Department of Paediatrics, and other partners working in     neonatal and child health. Findings will be published in academic journals and conference     proceedings in an effort to disseminate results to potential end-users. The research findings     of this study will be critical in the evaluation of future interventions.   "
75550|NCT02296918|"     To evaluate the safety and preliminary efficacy of acalabrutinib in combination with     obinutuzumab in 2 separate cohorts of patients.   "
75551|NCT02296905|"     This is an open-label, single-dose study designed to assess the pharmacokinetics and safety     of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to     those in subjects with normal hepatic function.      Twenty-four subjects will be selected and enrolled according to the subject selection     criteria: 6 subjects with mild stable chronic hepatic impairment (Group I), 6 subjects with     moderate stable chronic hepatic impairment (Group II), 6 subjects with severe stable chronic     hepatic impairment (Group III) and 6 subjects with normal hepatic function (Group IV).   "
75552|NCT02296892|"     A prospective, double-blind, randomized, placebo and active controlled, multi-center,     parallel group study comparing remimazolam to placebo, with an additional open label arm for     midazolam, in patients undergoing a bronchoscopy.   "
75553|NCT02296879|"     Mesenchymal epithelial transition factor (c-MET) is a receptor tyrosine kinase that, when     engaged by its ligand hepatocyte growth factor (HGF), has been implicated in various cellular     process including development as well as oncogenesis.      SAIT301 is a novel humanized monoclonal antibody targeting the alpha chain of extracellular     domain of c-MET. Binding of SAIT301 to c-MET blocks HGF binding and inhibits HGF-mediated     signaling. Furthermore, SAIT301 also induces efficient c-MET internalization from the cell     surface and subsequent degradation, resulting in inhibition of growth of the c-MET addicted     cancer cells.      The sponsor decided to enroll subjects with tumors that express c-MET (by     immunohistochemistry [IHC]) for this study, as the subjects with no c-MET expression are     unlikely to benefit from SAIT301 treatment.      Stage 1 of this Phase I study is designed to evaluate the safety, tolerability,     pharmacokinetic (PK) profile, and anti-tumor activity of SAIT301 administered as a single IV     infusion in 21 day cycles, for up to 4 cycles. Subjects without evidence of tumor progression     after 4 cycles will be eligible to continue on SAIT301 treatment if there is no evidence of     tumor progression for a further 4 cycles (Cycles 5 to 8). Biomarkers related to SAIT301     and/or tumor response will also be evaluated.Stage 2 will further evaluate the safety and PK     profile of SAIT301 in select types of cancers. Dosing frequency may be adjusted based on the     PK profile obtained during Stage 1.   "
75554|NCT02296866|"     The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin     has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes     in non-fasting patients undergoing emergency trauma surgery.   "
75555|NCT02296853|"     This study will evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and     it's metabolite tenofovir (TFV) along with the safety and tolerability of TAF in participants     with normal hepatic function and severe hepatic impairment.   "
75556|NCT02296840|"     Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric     population in the United States. It is generally a well-tolerated procedure with     post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following     adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or     re-admission to the hospital. Post-operative analgesia is most commonly managed with     narcotic-containing pain medication. In recent years however, there is evidence that some     patients may manifest increased sensitivity to narcotics, resulting in life-threatening     respiratory compromise. Though there is a theoretical risk that nonsteroidal     anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation,     evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains     inconclusive for these generally well-tolerated medications. The goal of this study is to     determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in     the management of post-operative pain following pediatric adenotonsillectomy, versus more     commonly used narcotic pain medication. The study design will be an initial retrospective     study to collect pilot data on the incidence of postoperative hemorrhage and indicators of     adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This     will be followed by a prospective, randomized, single-blind controlled study in which     orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone     (control intervention) in the postoperative period following adenotonsillectomy.   "
75557|NCT02296814|"     Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to     placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the nasal     and paranasal sinuses).   "
75558|NCT02296801|"     This study will look at effects the combination of palbociclib and letrozole may have on     estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative     breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine     therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal     women with ER-positive/HER2-negative breast cancer.   "
75559|NCT02296788|"     In the present study, we seek to elucidate the effects of aerobic exercise on fecal     microbiota following the aforementioned no exercise control group and two doses of aerobic     exercise training (the exercise training spans ~24 wks) in a cross-sectional sample.   "
75568|NCT02296671|"     In this study the investigators aim to: 1) confirm the objective response rate (ORR) observed     in the investigators initial study for patients with the TSER*2/*2 genotype 2) determine     whether PEMOX regimen is more worthy of future development for this patient genotype selected     population than FOLFOX based on the data indicating that pemetrexed may be a better TS     targeted agent than 5-FU.      Patients who are homozygous for the TSER*2 allele (TSER*2/*2) will be able to continue in the     study and will be randomized. Patients with other TSER genotypes will not be included and     will be considered screen fails.      The first 8 patients with the TSER*2/*2 genotype will be randomized 1:1 to receive treatment     with either PEMOX or FOLFOX (4 in each group).      Analysis of the objective response rate (ORR) in each treatment arm will occur after the     first 8 patients are enrolled. Using the proposed Bayesian design, subsequent patients will     be preferentially assigned to the better performing treatment arm based on continuous     real-time reassessments of ORR results.   "
75569|NCT02296658|"     The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of     intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with     pathologically positive lymph node after completely resected gastric cancer. Furthermore, the     investigators sought to compare the dosimetric differences between the volumetric-modulated     arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in     treatment planning for gastric cancer as adjuvant radiotherapy.   "
75570|NCT02296645|"     This is a randomized, paired-comparisons design where each subject receives two of the     planned treatments.   "
75571|NCT02296632|"     This study aims to provide preliminary evidence of the validity of a sensor-based assessment     of rheumatoid arthritis (RA) symptoms, and to collect structured qualitative feedback from RA     Enbrel patients regarding the potential of a future biosensor/PRO mHealth application. The     investigators' overarching hypothesis is that if patients have better and more timely     information about whether Enbrel is working, then they will become more empowered and engaged     in their treatment, more curious about how it may - or may not - be working, and potentially     more compliant with therapy. However, this hypothesis remains largely untested.   "
75572|NCT02296619|"     The purpose of this study is to determine the effects of Transversus Abdominis Plane Block on     hemodynamic variables, anaesthetic and analgesic requirement, and quality of recovery in     patients undergoing total abdominal hysterectomy   "
75573|NCT02296606|"     Prospective, observational, non-randomized study of interrater reliability of pupillary     assessments, comparing two clinical assessments to the Pupillometer.   "
75574|NCT02296593|"     Continuous lactate and glucose blood levels   "
75575|NCT02296580|"     This feasibility study will assess the effects of the Nativis Voyager therapy in patients     with recurrent GBM who have either failed standard of care or are intolerant to therapy. The     study will enroll and treat up to 64 subjects of which 32 will be treated with the Voyager     therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent chemotherapy.     Safety and clinical utility will be evaluated.   "
75576|NCT02296567|"     To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea (     aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF)     in the systemic circulation of Age Related Macular Degeneration patients currently treated     with these medications.   "
75577|NCT02296554|"     Biceps Tenodesis is currently advocated for older, less active patients, but to date is not     often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young,     active patients. The ideal surgical management for this pathology is not clearly known. More     surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young,     active population. If this study were to demonstrate that biceps tenodesis is similar to or     better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps     more importantly, it would likely mean a less involved rehabilitation and earlier return to     activities for patients with this pathology.   "
75578|NCT02296541|"     The purpose of this study is to evaluate the safety and immune response to three DNA vaccines     and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy,     HIV-uninfected adults.   "
75579|NCT02296528|"     Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used     in medicine. While great progress in biomedical devices has been made for many other     disorders, there is currently no device available to assist with the act of deglutition. The     investigators have developed a biomedical device (Swallow Expansion Device, SED) that assists     with swallowing by mechanically opening the upper esophageal sphincter and allowing food and     liquid to safely enter the esophagus. The SED has proven safe in cadaver and live animal     studies (Belafsky, 2010).   "
75580|NCT02296515|"     Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective     comparison study in patients undergoing regular intrathecal pump refill   "
75581|NCT02296502|"     The study aim is to prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum     Disorder (ASD) in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for     ASD and 150 children and adolescents referred for diagnosis who do not meet DSM-IV-TR     criteria.Families and children will be recruited from eight sites affiliated with the Autism     Treatment Network (ATN). Participants must be between the ages of 2.0 and 17.11 years who     undergo an ATN assessment at one of the eight sites. Both subjects who are found to meet     criteria of ASD/PDD and those who do not meet criteria (after completing the ATN assessment)     will be enrolled. After completing the standard ATN assessment, clinicians will complete a     DSM-IV and DSM-5 checklist for ASD/PDD.   "
75602|NCT02296229|"     This clinical trial studies stereotactic body radiation therapy in treating patients with     high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the     body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a     single, high dose of radiation directly to the tumor and may kill more tumor cells and cause     less damage to normal tissue. Studying quality of life in patients undergoing stereotactic     body radiation therapy may help identify the long-term effects of treatment on patients with     prostate cancer.   "
75757|NCT02294214|"     The primary objective of the study is to demonstrate and quantify the protective efficacy     (PE) of spatial repellent products in reducing the incidence of malaria infection in human     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between     intervention and control arms.   "
75582|NCT02296489|"     Asthma is a common chronic disorder of the airways characterized by periods of reversible     airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by     chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed     airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to     become life-threatening events. Severity of asthma exacerbation is assessed through medical     history and lung function measurements with Spirometer and requires full cooperation of the     patient. Thus, in uncooperative populations or during emergency medical situations the     spirometer cannot be used. As an alternative, capnography data has been proposed as an     indicator of bronchospasm in asthma. Previous studies found correlations between the     capnography parameters and methacholine challenge in asthma patients. However, the     relationship between capnography parameters and severity of asthma or severity of asthma     exacerbation have not been well characterized. The study hypothesis is that within the     clinical population that is invited to do the methacholine challenge, a different waveform     pattern in asthma patients will be detected and possibly a correlation between the severity     of obstruction and pattern of waveform during the methacholine challenge. In this proposed     feasibility observational study, sixty subjects, both men and women, who will be invited to     participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin     Medical Center, will be recruited to the study. Respiratory information will be recorded     using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine®     Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the     methacholine challenge.   "
75583|NCT02296476|"     Open-label, phase IIa, non-randomized, multicentric study of single-agent OTX015 in recurrent     GBM (glioblastoma Multiforme) patients after standard front-line therapy failure.      The first study step (dose escalation) will determine the maximum tolerated dose (MTD) using     standard 3+3 dose escalation enrolling 3 patients per OTX015 dose level (DL), with an     additional 3 patients to be enrolled at the first occurrence of dose-limiting toxicity (DLT).     MTD assessment will be based on the tolerability observed during the first 28 days of     treatment.      The second study step (expansion cohort) will assess OTX015 efficacy as measured by the     progression-free survival rate at 6 months (PFS-6) in recurrent GBM patients as assessed by     local investigators and confirmed by an independent central review committee. A two-stage     design is used in this step to allow for the possibility of stopping the trial early for lack     of efficacy.   "
75584|NCT02296463|"     This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and     female subjects ≥24 months of age and <72 months of age. Subjects will be without symptomatic     chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for     seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be     excluded if titers for either RSV/A or RSV/B are <1:16 (4 log2).      Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM     dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and     in one group placebo) will be used to maintain the study blind; all subjects will receive a     complete course of hepatitis A vaccine as a study benefit.   "
75585|NCT02296450|"     The purpose of this study is to see how skin conditions that are related to different kinds     of cancer or cancer treatments affect a patient's overall well-being. Skin conditions are     common in cancer patients and survivors. Sometimes, the skin condition is directly related to     the cancer. Other times, these conditions are a side effect of cancer treatment. Patients in     the study will be asked to fill out at least one questionnaire about how they feel about     their skin condition. If the patient needs to be treated for their skin condition, they will     be asked to complete the same questionnaire when they return for a follow-up visit. The     investigators hope the study will improve our understanding of how cancer patients feel about     their skin conditions. They also hope this study helps them learn how to improve the way we     treat skin conditions in cancer patients.   "
75586|NCT02296437|"     Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective.     However, patient concerns with cognitive side effects have encouraged trials of new,     non-convulsive forms of mild brain stimulation such as transcranial Direct Current     Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant     effects and is safe, painless and well tolerated. However, not all patients may have an     adequate response, raising the need to find ways of optimising efficacy. This clinical pilot     study will examine the feasibility and safety of combining tDCS with a cognitive training     task which engages the same brain region targeted by tDCS for treatment of depression.   "
75587|NCT02296424|"     The purpose of this study is to evaluate the efficacy observed with canakinumab dose     reduction in a subgroup of patients in the extension study CACZ885G2301E1.   "
75588|NCT02296411|"     The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF     5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as     well as to assess its safety.   "
75589|NCT02296398|"     Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of neoplasm of skin-homing T     cells that includes Mycosis Fungoid (MF), which is the most common, Sézary syndrome (SS), the     leukemia variant of MF, and other variants of CTCL which are less prevalent. Clinical     manifestations and prognosis are highly variable. Improving the management of this incurable     disease with limited toxicity is the main point of the current research. Romidepsin is a     well-tolerated histone deacetylase inhibitor which has demonstrated activity against advanced     stages of CTCL. In November 2009, it was approved by the US Food and Drug Administration     (FDA) for the treatment of CTCL in patients who have received at least one prior systemic     therapy. FDA-dose approved is 14 mg/m2 days 1, 8, 15 of a 21 day-cycle. It is said that it     should be continued as long as the patient receives benefit and tolerates the drug. We     experienced in our clinic that a long-term (>6 months) use of Romidepsin, even with spared     doses allows patients to maintain disease in complete remission or under control without     severe side effects. We aim to demonstrate how many patients have benefited of this     maintenance therapy, and detect the side effects related to the long-term use of Romidepsin,     as well as characterize those patients that can get benefit of this therapy.   "
75590|NCT02296385|"     To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements)     depending on genotype of relevant factors in lipid metabolism   "
75903|NCT02292316|"     The purpose of this study is to determine whether cognitive disorders are a risk factor for a     fracture after a fall independently of a bone fragility.   "
75591|NCT02296372|"     Critically ill patients are on high risk for increased serum glucose levels, leading to more     comorbidity and higher mortality risk. In patients with severe sepsis and septic shock     hyperglycemia is a typical finding. However the need of insulin therapy is associated with an     increased risk of hypoglycemia. Newly developed technologies for continuous glucose     monitoring in critically ill patients may improve glycemic control and reduce glucose     variability. The investigators will perform continuous glucose monitoring in critically ill     patients on ICU. Measurements will be done for a period of 72h per patient. The investigators     aim is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy     sensor glucose levels will be validated due to arterial blood gas measurements with the blood     gas analyzer. The investigators will investigate the influence of several factors like     oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on     accuracy and feasibility of the particular system. Furthermore Nursing staff will be given a     questionnaire to identify acceptance.   "
75592|NCT02296359|"     Respiratory viruses are known to be risk factors for asthma (e.g respiratory syncytial     viruses, RSVs, and Human Rhinoviruses, HRVs, may induce bronchiolitis, and wheezing illnesses     respectively). The common flu is also known to be a risk factor and the Centers for Disease     Control and Prevention (CDC) recommends that asthmatics receive the annual flu vaccine, as a     high-risk group for related asthma exacerbations. The investigators will be evaluating the     variation in individual responses over time after controlled immune activation following     influenza vaccination of monozygotic twins, both discordant for asthma, and concordant     non-asthmatic. The transition from initial healthy to immune-system activated physiological     states post vaccination will provide unprecedented molecular (omics) data on the molecular     dynamics of immune response to vaccination, and novel insight into the flu response. The     investigators will infer novel networks and pathways and as well as the dynamics of genes and     mechanisms involved in asthma, flu vaccination, and individual responses, and correlate them     to evaluated personalized genetic risks in the same study. The investigators will be able to     also contrast the vaccination response in asthmatic and non-asthmatic individuals, in a     longitudinal approach which has never been performed before using multiple-omics that     included an immunization response.   "
75593|NCT02296346|"     In this research study, the investigators will determine whether a procedure called     Extracorporeal Photopheresis (ECP) is helpful in preventing progression of disability in     people with SPMS when compared to monthly corticosteroid infusions. This study will determine     whether ECP has an effect on inflammatory cells in people with SPMS and whether it has a     beneficial therapeutic effect.   "
75594|NCT02296333|"     The purpose of the study is to determine whether the effect of ondansetron on the analgesic     effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen     and also reduce opioid consumption   "
75595|NCT02296320|"     Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused     by Staphylococcus aureus in high-risk patients.   "
75596|NCT02296307|"     This study hopes to improve early detection of ovarian cancer. It will determine if women     with bloating, abdominal distension, abdominal/pelvic pain, increased urinary frequency     and/or early satiety, benefit from earlier surgery after screening by CA-125 ovarian cancer     biomarker and transvaginal ultrasound.   "
75597|NCT02296294|"     This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device     called Body Composition Monitor (BCM) which measures the body composition (i.e. the water     content of the body).      Specifically, the investigators will evaluate the use of BCM for correct detection of     intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we     will test the change over time of the volunteers´ volume status after an intravenous fluid     therapy.   "
75598|NCT02296281|"     The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to     treat grade 2 or above radiation-induced lung injury patients.   "
75599|NCT02296268|"     Stroke is a leading cause of chronic disability here in Nova Scotia and globally. Aerobic     exercise is known to improve health by increasing energy levels, physical mobility, balance,     bone health, cardiovascular risk reduction, mental well-being, cognition, sleep, and quality     of life. Nonetheless, people remain woefully inactive after stroke, regardless if they are in     hospital or at home. The current investigative team and others have shown that even during     physiotherapy, exercise intensity is not adequate to increase physical fitness. Consequently,     patients are often deprived of a treatment that could improve their recovery. Why does this     gap between evidence and clinical practice persist? Through a national survey the current     team found that an important contributing factor is lack of appropriate screening (especially     stress tests) to ensure that patients are safe to engage in aerobic exercise. This project is     designed to close this evidence-practice gap by establishing a state-of-the-art aerobic     exercise screening and prescription clinic at the Nova Scotia Rehabilitation Centre (NSRC).     The intent is to compare outcomes of stroke rehabilitation participants before and after the     clinic is underway and determine if the clinic has a positive effect on the confidence of     NSRC physiotherapists to use aerobic exercise safely and effectively in stroke     rehabilitation.   "
75600|NCT02296255|"     The purposes of this study are to evaluate the effectiveness of vaccination in 25-year old     women at the time of their first access to cervical cancer screening, to understand the     impact of vaccination on screening activity; to evaluate the immune response following     vaccination; to study the dynamics of the infection after vaccination, including the possible     change in the frequency of non-vaccine HPV types, to evaluate cytological abnormalities     reductions in vaccinated women and to assess if HPV test in urine sample could be a useful     non-invasive method to monitor HPV status in younger women.   "
75601|NCT02296242|"     This study is being performed to assess the safety, tolerability, and preliminary clinical     effects of BVD-523 given orally, twice daily for 21-day cycles, in patients with Acute     Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS).   "
75617|NCT02296034|"     The purpose of this study is to measure blood glucose variation in youth prior to and after     participation in a healthy lifestyle intervention program. The hypothesis is that youth with     more severe obesity and those further along in puberty will have more glycemic variability,     and that glycemic variability will be improved by participation in the lifestyle intervention     program.   "
75603|NCT02296216|"     Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy     can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several     studies reported long-term extra-pituitary side-effects of conventional radiotherapy.     However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a     highly precise stereotactic technique, that has been used as an effective treatment of     acromegaly.      Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary     side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.      Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma     Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed     patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10     years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of     cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and     growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.      Expected results: We should be able to determine whether Gamma Knife radiosurgery is a     long-term safe technique. This result might modify the management and follow-up of patients     with acromegaly unsuccessfully treated by surgery.   "
75604|NCT02296203|"     This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type,     irinotecan-resistant metastatic colorectal cancer patients progressing after an initial     response to a first-line cetuximab-containing therapy, receive a rechallenge third-line     treatment with cetuximab plus irinotecan.   "
75605|NCT02296190|"     The primary objective of this study is to demonstrate the superiority of at least 1 dose of     intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an     electrophysiology (EP) laboratory.   "
75606|NCT02296177|"     Breast cancer is the most common cancer and the second leading cause of cancer related death     in American women. Regular screening, early diagnosis, and timely treatment initiation have     been shown to reduce breast cancer morbidity and mortality. However, disparities continue to     exist across the breast cancer continuum for underserved women, particularly minority women.     The reduction of disparities in breast cancer outcomes is a major goal of Healthy People 2020     and the National Cancer Institute. However, the preventable burden of late stage breast     cancer will continue until the investigators close the gap between what is known about     prevention and what is implemented in the community. Although many sources of information     exist about theory and [theory-] and evidence-based interventions (EBIs) to promote     mammography screening, their adoption and use in the community has been limited and haphazard     at best.   "
75607|NCT02296164|"     The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study     that longitudinally follows patients with MF-CTCL who are receiving therapy with Valchlor.     Patients will be followed prospectively for a maximum of 1 year from the date of signed     informed consent (enrollment) until end of study. Continuation in the study is not contingent     on continuation of Valchlor.   "
75608|NCT02296151|"     The primary objective of this study is to determine if a more specific exercise routine that     incorporates a progressive hip stability program will help to rehabilitate the hip and reduce     symptoms of iliotibial band syndrome more than conventional hip exercises. Three different     exercises interventions will be compared to determine its effectiveness in reducing pain,     improving function and returning subjects to running symptom free. Secondary objective for     this study is to establish an intervention program for female runners with this injury. There     will be three treatment arms and participants will be randomly assigned to one of three     groups: Group A- control (stretching), group B (conventional hip exercises and group C     (experimental treatment- specific progressive hip exercises).   "
75609|NCT02296138|"     The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed     dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on     moderate to severe COPD exacerbation in patients with severe to very severe COPD.   "
75610|NCT02296125|"     To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth     factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non     Small Cell Lung Cancer   "
75611|NCT02296112|"     This phase II trial studies trametinib in treating patients with melanoma with v-Raf murine     sarcoma viral oncogene homolog B (BRAF) non-V600 mutations that has spread to other places in     the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
75612|NCT02296099|"     The purpose of the study is to determine if the administration of liposomal bupivacaine at     the completion of a suburethral sling procedure will result in decreased postoperative pain     compared to no injection.   "
75613|NCT02296086|"     The study will assess the difference in functionality between early vs. standard mobilization     after hip fracture in the Chinese population.   "
75614|NCT02296073|"     To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to     the pediatric intensive care unit after surgery.   "
75615|NCT02296060|"     To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT   "
75616|NCT02296047|"     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality     and disability throughout the world, leading to a heavy social and economic     burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to     reduce dyspnea, improve exercise tolerance and improve health status. However,conventional     lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in     one second (FEV1) frequently fail to detect significant functional responses to     bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical     and scientific reasons to develop a new tool to objectively assess the effect of different     treatments including bronchodilator on COPD. Our previous study showed that Ventilation-drive     coupling may be more sensitive and accurate to evaluate the efficacy of inhaled     bronchodilators in patients with COPD because it could better reflect the pathological and     physiological characteristics of COPD.      Based on the above conclusion, the present study were performed using the experimental     methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive     coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable basis     for the clinical application of this index.   "
75618|NCT02296021|"     This study aims at evaluating efficacy and safety of berberine-containing quadruple     therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing     quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori     eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior     to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status     will be randomized to one of the treatments described above. At week 2 and 6 follow-up     visits, a urea breath test(UBT) will be performed to confirm eradication.   "
75619|NCT02296008|"     3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function     and 3D topographic picture of pressures along the anal canal.      Until now, it has been used only in adult population to evaluate defecatory disorders.      Congenital anorectal disorders are severe conditions and may present wide spectrum of     symptoms from gastrointestinal tract.      The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal     disorders such as Hirschsprung's disease and anorectal malformations.      It may help for better understanding of pathophysiology of anorectal area and allow for     planning improved procedures in these patients.      Moreover, the investigators study may elucidate the real usefulness of the procedure in     management of disorders of gastrointestinal tract in pediatric population.   "
75620|NCT02295995|"     The purpose of this study is to examine whether posttraumatic stress disorder (PTSD) symptoms     impact adherence to a 12-week physical activity program and whether exercise can help improve     PTSD symptoms and health outcomes in older Veterans. Forty Veterans over the age of 60 with     PTSD will be recruited to participate in a 12-week physical activity program consisting of     aerobic and strengthening activities. Participants will be randomized to an intervention arm     or usual care wait-list control.   "
75621|NCT02295982|"     The purpose of this study is to describe the postoperative outcomes after laparoscopic     transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with     a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of     our experiences from the previous study to optimize the postoperative outcomes.   "
75622|NCT02295969|"     Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days     of treatment.   "
75623|NCT02295956|"     The goal of this research study is to learn if it is possible to start a home-based exercise     and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer     before surgery (pre-operative rehabilitation, also known as prehabilitation).   "
75624|NCT02295943|"     The macular hole formation takes place in the centre of the retina. A closure of the macular     hole is believed to take place if the central retinal area is kept dry in the postoperative     period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the     supine position in the first postoperative days. The investigators have developed a     positioning measuring device which can measure the extent of supine positioning time.     Patients are to carry the positioning measuring device during the first postoperative 24     hours. Hereby the investigators search new knowledge concerning patients compliance and its     relation to macular hole closure.   "
75625|NCT02295930|"     This is a phase II randomized study of 4-months induction first-line chemotherapy with     FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients     affected by KRAS wild type (wt) mCRC.   "
75626|NCT02295917|"     The investigators aim to evaluate the width of the endometrial myometrial zone in     participants during natural menstrual cycle by using specific computerized application on 3     dimensions sonographic images of their uteri.   "
75627|NCT02295904|"     Video documentation of vaginal deliveries to evaluate the impact of the support of the     perineum   "
75628|NCT02295891|"     Primary hyperhidrosis is a pathological condition characterized by the idiopathic and     excessive secretion of sweat beyond normal physiological demand and is localized at     particular foci such as the face, axilla, palms of the hands, and soles of the feet. Patients     seeking medical attention for hyperhidrosis often report disruptions to their professional     and/or social lives due to sweating and subsequently experience many psychosocial     difficulties, such as anxiety, social phobia, and depression. Therefore, a psychiatric     explanation of causality is frequently offered for these patients during diagnosis. Excessive     sweating is often mistakenly interpreted as a symptom of an anxiety disorder and can be cause     for social embarrassment, exacerbating emotional stress and social avoidance. As currently     constituted, the treatment of secondary psychosocial symptoms in primary hyperhidrosis is     poorly understood and requires further investigation.   "
75629|NCT02295878|"     Cardiovascular disease (CVD) is currently the leading cause of death worldwide. Epidemiologic     studies have shown a diet rich in plant food protects against chronic degenerative diseases     especially cardiovascular disease. Many of these studies have highlighted a potential role     for phenolic compounds, which are abundant secondary plant metabolites, and which provide     antioxidant and anti-inflammatory properties and are increasingly being shown to have an     important role in influencing critical cell signalling pathways. A less well known, but     nevertheless rich source of polyphenolic compounds is seaweed. In Ascophyllum nodosum, a     common brown alga in the British Isles, polyphenols have been reported to comprise up to 14%     of the dry weight of the plant. Some studies suggest that the potential antioxidant and     anti-inflammatory benefits of seaweed-derived polyphenols may yield highly bioactive     components with commercial potential for food and pharma applications. Preliminary work in     our laboratory has revealed potent antioxidant activity of Ascophyllum nodosum extracts.      Therefore, the aim of this randomised, double-blind, placebo controlled, crossover design     study is to investigate the biological activity of a food grade seaweed polyphenol extract in     terms of reducing oxidative damage to DNA, modulation of inflammatory responses and reduction     on chronic, low level inflammation in vivo. Apparently healthy volunteers (aged 30-65 years)     will be randomised to receive either a capsule containing 100mg seaweed extract or a matched     placebo daily for an 8 week period, with an 8 week washout period between each treatment.     Fasting blood and urine samples will be taken from each volunteer at 4 time-points during the     study, at baseline and completion of the 2 treatment phases.   "
75630|NCT02295865|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of     JNJ-38518168 in participants with moderate to severe plaque-type psoriasis (common     genetically determined, chronic, inflammatory skin disease characterized by rounded     erythematous, dry, scaling patches).   "
75631|NCT02295852|"     Mediterranean diet is relatively poor in calcium (about 700 mg/daily) whilst there are     several reports indicating beneficial effects of calcium-rich diets. Aim of the preset study     is to evaluate the effects of a low-sodium, low-lipid diet enriched in calcium, mainly from     vegetables instead of dairy products, on blood pressure, body weight a main parameters of the     glucose and lipid metabolisms.      This study is a randomized, parallel group trial that will be performed in the Outpatient     Clinic. At least 150 patients with arterial hypertension and/or increased body weight (IMC>     28 kg/m2) will enter the study program. After a 3 month low-lipid low-salt diet that will be     prescribed to all patients, they will be divided in two groups. The first will change the     diet to that similar for total calories, percent composition of macronutrients and salt but     enriched in calcium (about 1200 mg/daily) whilst the alternative group will continue the     first diet. The observation period will be of 1 year with anthropometric (body weight and     height, waist circumference), hemodynamic (blood pressure and heart rate) and metabolic     (cholesterol, triglycerides, fasting blood glucose, uric acid, calcium, phosphorus, sodium     and potassium) controls after 3-6 and 12 months.   "
75632|NCT02295839|"     This pilot randomized controlled trial examined the feasibility, acceptability and     effectiveness of an intervention to improve sleep quality and decrease fatigue levels in     children with a diagnosis of ALL, during maintenance treatment. Families were randomized to     usual care or the intervention. The intervention included a sleep hygiene and relaxation     education session with a nurse practitioner, literature for home, two story books, and a     follow-up phone call. Self-reported measures were used in addition to actigraphy to measure     children's quality and quantity of sleep.   "
75633|NCT02295826|"     Rationale: To date, anticoagulant therapy in acute stroke has also been limited by excess     hemorrhagic events. The oral anticoagulant dabigatran is a novel agent, which has been shown     to be associated with much lower intracranial hemorrhage rates. It has been suggested that     this agent may provide the superior benefits of anticoagulation in acute stroke, without the     concomitant increase in hemorrhage risk associated with heparin/LMWH or warfarin.      Study Design: DATAS II is a randomized, open label blinded endpoint trial. Participants     (n=300) with TIA or ischemic stroke (NIHSS score <9) will be enrolled within 48 hours of     symptom onset from approximately four (4) health care centres across Canada. All participants     will have an MRI with DWI lesion volume < 25 ml. Participants will be randomized 1:1 to     treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care). All     stroke patients will initially be screened with a non-contrast CT scan of the brain. The     first MRI will be performed within 48 hours of symptom onset. Imaging studies will be     repeated at day 30. All patients will be assessed clinically at Day 30 and Day 90.      Study Aims:        1. Establish the safety of early anticoagulation with the novel oral anticoagulant          dabigatran in acute cerebrovascular syndrome patients.        2. Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT)          associated with these treatments.        3. Identify predictors of HT associated with acute dabigatran treatment.      Hypothesis: The Investigators hypothesize that symptomatic HT rates in dabigatran and ASA     treated patients will not be significantly different.      Study outcomes: The primary outcome is the rate of symptomatic hemorrhagic transformation     (HT), defined as a parenchymal hematoma, which is >30% of the infarcted area on DWI, with     substantial space- occupying effect, associated with clinical worsening (≥4 point increase in     National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment     initiation. The major secondary outcome the rate of asymtomatic HT see on day 30 MRI     sequence.   "
75634|NCT02295813|"     The purpose of this study is to assess the clinical and laboratory safety and to determine     the pharmacokinetic profile of FBF001.   "
75635|NCT02295800|"     The study design includes an observational prospective cohort of HIV-positive     pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately     postpartum) from prevention of mother-to-child transmission (PMTCT) programs and followed     until the infants reach the age of 18 - 24 months and semi-structure interviews with a     sub-set of these women. A second study component involves semi-structured interviews with     health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at the     selected study facilities.   "
75636|NCT02295787|"     The investigators of this study plan to investigate the feasibility and efficacy of repeated     doses of intranasal ketamine in severely depressed patients who are at least 65 years of age     and experiencing suicidal ideation. The results of the study could lead to development of new     strategies for treating depression.   "
75637|NCT02295774|"     Single Centre, open label assignment phase II clinical study.      To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to     endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma     H2AX analysis, compared to control biopsies.   "
75638|NCT02295761|"     Objectives: Aim of this study is to evaluate the effectiveness of Facebook-delivered     lifestyle counseling intervention on overweight and obese adolescent's physical activity, BMI     and adherence to healthy lifestyles.      Design: A 12-week, randomized controlled trial with three, 24 and 36 month follow-up.      Settings: One of the Northern Finland healthcare districts school health care units.      Participants: all overweight or obese 13-16 years old adolescent and their parents were     invited to study.      Methods: Adolescents were stratified by gender, age, and self-reported physical activity and     they were randomized into three groups. Two experimental groups, where those both got     Facebook-delivered lifestyle counseling and one of the experimental groups got activity     monitor which showed the daily activity. One group served as a control group. Parents were     allocated to intervention groups according which group their adolescent were randomized.      Outcomes: physical activity,body mass index (BMI) adherence to healthy lifestyles. Baseline     measurements have been done and assessment to adherence to healthy lifestyles have been     measured. Follow-up measures have been conducted three months after baseline. Adherence to     healthy lifestyles measurement follow-up is at 24 and 36 months after intervention.   "
75639|NCT02295748|"     This is an open label, long-term extension study in approximately 24 male DMD subjects     consisting of children (ages 4-12, inclusive) and adolescents (ages 13-16, inclusive) who     participated in the MP-104-CL-005 PK study.   "
75640|NCT02295735|"     The aim of this randomized controlled trial is to test the efficacy of preventive dressings     for pressure ulcer prevention.   "
75641|NCT02295722|"     Objective of study: To evaluate the safety and efficacy of infusional gemcitabine prior to     HDM (high-dose melphalan) as HDCT (High Dose Chemotherapy) followed by autologous stem cell     transplantation in patients with relapsed/refractory lymphoma.   "
75699|NCT02294968|"     The aims of this study are to determine whether a group-based parent support program (Family     Startup) can lead to early improved parental sense of competence, family relations, and     child development. Evaluation is based on a randomized controlled trial, with half of the     participants receiving Family Startup and the other half receiving treatment as usual.   "
75642|NCT02295709|"     Cervical transforaminal epidural steroid injections (TFESI) are indicated in cervical     radicular pain resistant to conservation therapy, by which steroids can be delivered into     anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the     upper limb or neck. Cervical TFESI is traditionally commended to perform with guidance of     fluoroscopy or CT. As fluoroscopy can not monitor the injection route whether it pass vessel     or not, many serious neurological complications caused by inadvertent intra-arterial     injection have been reported2. Here, the investigators will introduce a novel cervical TFESI     guided by ultrasound, which incidence of inadvertent vessel injury or injection might be     lower than those guided by fluoroscopy.   "
75643|NCT02295696|"     EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue     tools for adults with poorly regulated Type 2 diabetes.   "
75644|NCT02295683|"     The purpose of this study is to document safety and efficacy of renal sympathetic denervation     treatment in subjects with uncontrolled hypertension by using Iberis renal denervation     system.   "
75645|NCT02295670|"     Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining     a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines     emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR).     These guidelines also suggest that skilled operators should be able to secure the airway     without interrupting chest compression. The aim of the study was to compare time and success     rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency     intubation during simulated pediatric CPR.   "
75646|NCT02295657|"     The aim of this study was to compare time, success rates of different double-lumen tubes in     intubation in a standardized manikin model.   "
75647|NCT02295644|"     Introduction. Temporomandibular disorders (TMD) are a group of conditions that are     multifactorial in nature, and it primarily presents with symptoms of pain and decreased     functional capacity. Therapeutic ultrasound is a method of physical therapy that has shown     clinically to provide immediate relief of pain in patients with different musculoskeletal     disorders. In this study, for the purpose of immediate management of painful masticatory     muscle and tissues, the investigators attempt to understand the mechanism of therapeutic     ultrasound by exploring the physiologic changes peripherally and centrally. In addition, the     investigators aim to determine if there is a dose response relationship between two different     intensities (0.4 W/cm2 and 0.8 W/cm2) and between two sets of duty cycles (50% and 100%). A     third purpose is to determine if therapeutic ultrasound applied to the masseter muscle is     capable of eliciting segmental effects in the temporalis muscle. Methods. A total of 28 adult     females with bilateral myalgia according to Diagnostic criteria for TMD (DC/TMD) will be     recruited for this investigational trial. Each subject will be randomly allocated to one of     the four ultrasound intervention groups each of which has different settings. Using     Sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for     five minutes on each side of the face. A template will be used to confine the borders of the     muscle and to determine the sites for the repeated outcome measures. Outcome parameters of:     self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and     intraoral muscle temperatures will be measured for masseter and temporalis muscles on each     side of the face, and will be assessed at baseline and after intervention on each side.   "
75648|NCT02295631|"     The aim of this study was to compare time, success rates of different tracheal tubes     (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in     a standardized manikin model.   "
75649|NCT02295618|"     The objective of this study is to compared effectiveness of intubation using ETView VivaSight     SL and standard tracheal tube during resuscitation performed by a novice-physicians.   "
75650|NCT02295605|"     Forty six patients with knee osteoarthritis will be randomly allocated into two groups:     water-based exercises and land-based exercises. Both of them will receive a strengthening     exercise protocol for lower limb muscles. A blind investigator will assess the patients     before and immediately after, 3 months and 6 months following the interventions. The main     outcomes will be pain, function and strength.   "
75651|NCT02295592|"     TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized     controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids     recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.   "
75652|NCT02295579|"     From the earlier studies the investigators have treated women with bacterial vaginosis and     cronic vulvovaginal candida. The investigators have then treated them with laktobacilli 10     days for 2 month. The investigators will continue to follow them and investigate if treatment     with lactobacilli every week for 6 month will increase cure rate.   "
75653|NCT02295566|"     The lungs of most patients with cystic fibrosis (CF) become chronically infected with     bacteria called Pseudomonas aeruginosa during childhood. This infection is now known to     consist of free-living bacteria (known as planktonic bacteria) and bacteria in colonies on     body surfaces known as biofilms. The bacteria in biofilms are more resistant and tolerant     to antibiotics. Current CF treatment of exacerbations aims to eradicate or control     pseudomonal infection using aggressive antibiotic regimes.      Despite this treatment many patients develop chronic infection which is never cleared.     Chronic infection causes damage to the lungs. Patients colonised with Pseudomonas are more     unwell and die at a younger age. Our laboratory has established that low dose nitric oxide     (NO) can disrupt pseudomonal biofilms in the laboratory. This pilot study will discover     whether non-toxic levels of NO administered to participants during an episode of acute     infection (exacerbation) will disrupt bacteria from biofilms and increase the effectiveness     of antibiotic therapy. This protocol describes a participant-blind randomised controlled     pilot study of treatment with nitric oxide gas during an acute infective exacerbation (also     known simply as an acute exacerbation). Patients with CF aged 12 or above will be asked to     take part.      They will be randomised to receive 7 days either of inhaled nitric oxide gas or placebo     alongside standard therapy during an exacerbation. Sputum samples will be obtained before,     during and after the treatment period for microbiological analysis. The primary endpoint will     be the microbiological effect on bacterial biofilms before and after NO adjunctive therapy.     Secondary microbiological endpoints will include the between group differences in pseudomonal     colony forming units (CFU‟s), biofilm NO levels and detailed characterisation of biofilms     before and after treatment.      Secondary clinical endpoints will include lung function and well-established indicators     quality of life. The aim of this randomised pilot study is as proof of concept and to guide     the design of a large multi-centre trial to definitively evaluate the effectiveness of NO or     NO donors as adjunctive therapy in CF.   "
75654|NCT02295553|"     The purpose of this study is to examine the dose-response relationship of ketamine in     combination with propofol.   "
75708|NCT02294851|"     This is a randomized, double-blind, placebo controlled, single ascending dose escalation,     safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an     intravenous infusion in healthy subjects.   "
75655|NCT02295540|"     This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery     works in treating patients with squamous cell carcinoma of the oral cavity that has spread to     other places in the body. Hypofractionated radiation therapy delivers higher doses of     radiation therapy over a shorter period of time and may kill more tumor cells and have fewer     side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor     making it easier to be removed, may reduce the risk of the cancer coming back, and may be a     better treatment for squamous cell carcinoma of the oral cavity.   "
75656|NCT02295527|"     Hip fractures resulting from falls increase substantially with advancing age and less than a     half of the elderly that have sustained and survived after the surgery regain their former     levels of mobility. There is increasing evidence that rehabilitation interventions involving     exercises and extended beyond the sub acute phase or even in a later stage of care have a     positive impact on various functional abilities. The purpose of this study is to determine if     an exercise program training for people who have suffered a fall-related hip fracture will     improve functional mobility when compared with usual care. Randomized controlled trial using     blinded assessors and intention-to-treat analysis. We will recruit 82 older adults, 60 years     or over who have suffered a hip fracture due to a fall and have or have not completed     physiotherapy and/or rehabilitation. These participants will be in a later stage     rehabilitation phase (6 months up to 2 years after the fracture). Participants randomized to     the Intervention Group (IG) will be submitted to a physical exercise program involving a     progressive and challenging balance training and a neuromuscular and functional training of     the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour,     in the first, second and third month after randomization and will be oriented to perform     exercises, twice a week, through a booklet. Visits to follow up exercises progression will be     conducted once a month, from de fourth to the sixth month and each two months until the end     of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly     phone calls to increase exercise adherence. The control group will receive usual care. The     primary outcome will be mobility-related disability and participants will be assessed in the     baseline, at the end of the intervention (3 months), at 6 and 12 months. The participants     will receive monthly phone calls to investigate falls and exercise adherence. Adverse effects     will be monitored.   "
75657|NCT02295514|"     Despite major advances in the treatment and understanding of the pathophysiological     mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. With a     prevalence > 20% in intensive care units, it is now in a population increasingly aging with     many co-morbidities, a real public health problem. Thus, changes in treatment to     physiological axes could change the prognosis of these patients. Protein Tyrosine Phosphatase     1B (PTP1B) is involved in the negative regulation of many cellular pathways such as the     response to insulin, leptin and certain growth factors and endothelial nitric oxide     production. PTP1B appears to be particularly involved in the control of endothelial function     and insulin secretion. Under these conditions, encouraging results have been obtained in a     model of insulin resistance (obesity, diabetes) and as part of pro-angiogenic therapy by     inhibition of PTP1B on models of heart failure. Recent advances have broadened the     pathophysiological implications of PTP1B conferring a potential role in the regulation of     inflammatory processes. In an experimental model of septic shock (Inserm 1096), the     investigators demonstrated a significant improvement in survival and cardiovascular function     in genetically deficient mice PTP1B (PTP1B - / -). Finally, PTP1B is involved in the     downregulation of the signaling pathway of insulin via a feedback phenomenon. Septic shock     induces many changes in carbohydrate metabolism. These changes result in hyperglycemia     associated with insulin resistance, an independent risk factor of morbidity and mortality.     Taken together, these data suggest that the expression of PTP1B could be useful in septic     patients by modulating insulin resistance and thus the prognosis of these patients. This     justifies the investigator clinical research project on the relationship between the     expression of PTP1B levels, glycemic status and prognosis evaluated by the SOFA score in     patients with septic shock with multiple organ failure.   "
75658|NCT02295501|"     The objective of this Phase 1 safety study is to provide access to the potential therapeutic     benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to     plasma from donors who may be infected with other transfusion-transmitted pathogens, not     detectable by current licensed donor testing procedures, will be mitigated by using pathogen     inactivation to minimize the risk of the TTI from these donors, who would otherwise be     deferred and ineligible for blood donation.   "
75659|NCT02295488|"     Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a     very rapid increase in doses of venom extracts administered during the SIT in a day without     systemic reaction of the patient which is not yet explained. The hypothesis is that this good     tolerance is due to a rapid decrease in the response of mast cells and basophils to the     allergen..      The main objective is to study basophil activation in response to the allergen during the     first day of desensitization, measured by basophil activation test.      The initiation of desensitization follow a protocol of rapid growth rates. The basophil     activation level in the course of desensitization will be analyzed by flow cytometry after in     vitro stimulation by allergen.      Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the     expression of different proteins in blood basophils will be studied by measuring their     messenger RNAs   "
75660|NCT02295475|"     ASTRO-APS is a prospective, randomized, open-label blinded endpoint pilot study among     patients with a clinical diagnosis of the AntiPhospholipid Syndrome and are already taking an     anticoagulant for the secondary prevention of thrombosis (blood clots). Subjects will be     randomized to receive either warfarin (target INR range 2-3) or apixaban 5 mg twice daily.     Patients will follow up with the study team for 13 months. 2 in-clinic follow-up visits will     be performed as well as 4 telephone follow-up visits. Study participants will be asked to     consent to follow up telephone calls and questionnaires at 3 month intervals following the     completion of the study procedures for the main portion of the study.   "
75661|NCT02295462|"     Background: Up to 90% of nursing home residents with dementia experience behavioural and     psychological symptoms like apathy, agitation, and anxiety. According to analyses of     prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line     treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed     for inappropriate reasons and too long without regular review. The use of antipsychotics is     associated with adverse events like increased risk of falling, stroke, and mortality. This     study aims to investigate whether a person-centered care approach developed in the United     Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators     trial is to achieve a clinically relevant reduction of the proportion of residents with alt     least one antipsychotic drug prescription.      Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day     initial skill training on person-centred care and on-going training and support programme)     with a control group receiving optimised usual care. Both study groups will receive a     medication review by an experienced psychiatrist with feedback to the prescribing physician.     Overall, 36 nursing homes from East, North and West Germany will be included and randomised.     The primary outcome is defined as the proportion of residents receiving at least one     antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life,     behavioural and psychological symptoms of dementia as well as safety parameters like falls     and fall-related medical attention. Cost parameters will be collected and process evaluation     will be performed alongside the trial.   "
75662|NCT02295449|"     Background: Bracco has released the VueBoxTM-Prostate software, aimed at distinguishing     prostate cancer from prostate benign peripheral zone (PZ) at contrast-enhanced ultrasound     (CEUS) using SonoVue® as contrast agent.      The software analyses the ascending phase of enhancement (wash-in) and calculates the mode     and the dispersion (sigma) of the wash-in rate in a given region of interest. The diagnosis     of cancer is based on the combination of these two parameters.      The main objective of the study is to evaluate the diagnostic value of the VueBoxTM-Prostate     software in distinguishing prostate cancer from normal PZ at contrast-enhanced ultrasound     (CEUS).      The secondary objective is to evaluate the diagnostic value of the wash-out rate, the time to     peak, the transit time and the area under the enhancement curve (parameters not used by the     VueBoxTM-Prostate software) in distinguishing prostate cancer from prostate benign peripheral     zone at contrast-enhanced ultrasound (CEUS).      The study will enroll patients referred for prostate biopsy. The US transrectal probe will be     inserted and the local anesthesia performed as per the institution's standard of care     protocol. Then, the biopsy operator will choose an axial plane likely to contain cancer (e.g.     based on MRI or Digital rectal examination results). Half a vial (2.4 ml) of SonoVue® will     then be injected and the ultrasound enhancement of this plane will be recorded during 2     minutes while the biopsy gun is already in place. Then, the biopsy will be taken while the     recording is still on, so that it will be possible to calculate quantitative enhancement     parameters at the exact location of the biopsy.      Then, the operator will choose a plane that is likely not to contain cancer in the opposite     prostate lobe and the same process will be repeated with injection of the second half of the     vial.      The rest of the biopsies will be performed as per the institution's standard of care     protocol.      The two recordings will be sent to Bracco's Research center in Geneva in order to:        -  Predict the biopsy result (cancer vs benign) based on the VueBoxTM-Prostate software          results        -  Calculate the wash-out rate, the time to peak, the transit time and the area under the          enhancement curve at the biopsy location.      The two biopsy samples performed after the injection of SonoVue® (as the rest of the biopsy     samples) will be processed and analysed at the institution's department of Pathology and     their results will be blinded to the Bracco's Research center.      The correlation between the biopsy results, the VueBoxTM-Prostate software results and the     wash-out rate, time to peak, transit time and area under the enhancement curve will be     performed by the study investigator.      In total, 130 patients will be included (hypotheses of 20% of malignant biopsy cores and of     an area under the ROC curve of 0.85 for the VueBoxTM-Prostate software).   "
75663|NCT02295436|"     The primary objective of the the study was to evaluate the pharmacokinetic properties of     minodronic acid tablets following single and multiple oral administration in healthy Chinese     subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was     also explored.   "
75664|NCT02295423|"     The investigators hope to survey anesthesiologists who have participated in a non-CME     regional anesthesia workshop at VAPAHCS over the past 4 years on the number and types of     nerve block procedures that they performed, nerve localization method (e.g., ultrasound,     electrical stimulation, or both), and whether the nerve blocks performed were     single-injection or catheter-based.   "
75665|NCT02295410|"     The intent of this study is to assess whether cognitive functioning improves as     Post-Traumatic Stress Disorder (PTSD) symptoms decrease as a step toward developing an     objective measure of PTSD improvement. The study also evaluates the feasibility and     effectiveness of home-based telemental health care (HBTMH) compared to usual care in the     treatment of rural Veterans with posttraumatic stress disorder (PTSD). For this     assessment-only study, the investigators plan to assess approximately 200 Veterans in total,     of which 150 will be undergoing regular evidenced-based therapy (EBT) for PTSD, and 50 will     be receiving other treatment as usual (TAU). The 150 veterans in the EBT group will be     undergoing Cognitive Processing Therapy (CPT), Cognitive-Behavioral Couple Therapy (CBCT),     Prolonged Exposure (PE), or Seeking Safety (SS) treatment for PTSD in clinic or via     home-based telemental health (HBTMH). The study will also assess a comparison group of     approximately 50 rural Veterans with PTSD diagnoses who are receiving treatment as usual     (TAU) (neither EBT nor HBTMH). The HBTMH patients will be recruited from an Office of Rural     Health (ORH) funded project to VA Pacific Island Health Care System (VAPIHCS), based at the     National Center for PTSD (NCPTSD) and funded to offer 100 rural Veterans mental health     treatment in their homes. This research protocol intends to assess rural veterans with PTSD     who are being seen within this clinic versus those who have been referred for HBTMH yet who     are ineligible for pragmatic purposes, with outcomes including feasibility,     cost-effectiveness, and clinical effectiveness. The cognitive change will also be measured in     patients with PTSD diagnoses receiving EBT PTSD treatment at VA clinics in the Pacific     Islands.   "
75666|NCT02295397|"     Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food     provocation with a dose of the allergenic food to which 5% of the respective food allergic     population (ED05) has been calculated to respond with allergic reactions (single shot study).      In patients with a hazelnut or peanut allergy a double-blind placebo controlled food     challenge with cookies containing either placebo or hazelnut and peanut respectively will be     performed to determine threshold levels eliciting an allergic reaction. The results for     threshold levels determined by cookie matrix will be compared to the results gained from the     EuroPrevall project (matrix comparison study).      In patients with a walnut allergy double-blind placebo controlled provocation with walnut     will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the     impact of PPI on the threshold level and on the clinical manifestation.   "
75667|NCT02295384|"     For the majority of patients, management of HIV-1 infection involves effective and well     tolerated antiretroviral therapy with simplified pill load and dosing, exemplified by the     availability of single tablet regimens (STRs) with single tablet once daily dosing. STR     therapy has been shown to improve adherence and reduce hospitalisations (Cohen et al., 2013;     Sax et al., 2012).      However, the aging of the HIV cohort in Australia and globally has raised issues of     increasing co-morbidities and consequent polypharmacy to manage these (Jansson & Wilson,     2012; Edelman et al., 2013).      Polypharmacy may not only impact on adherence, but also increases the potential for drug-drug     interactions (Holtzman et al., 2013).      Stribild, a highly effective STR, contains cobicistat to boost the levels of the component     integrase inhibitor, elvitegravir. Cobicistat does not have antiretroviral activity, but acts     by inhibiting Cyp3A4 of the cytochrome p450 metabolic pathway. Other drugs metabolized via     this pathway may be affected by this drug-drug interaction (Rogatto et al., 2014).     Additionally there is evidence of increased risk of nephrotoxicity with co-administration of     tenofovir and non-steroidal anti-inflammatory medication (NSAIDS) (Marcotte et al., 2008).      Data on use of concomitant medications in Australian patients with HIV is sparse. This study     aims to determine, in a large caseload community HIV practice, the use of concomitant     medications in HIV, patient pill load and dosing frequency, and potential drug-drug     interactions with stribild.   "
75668|NCT02295371|"     Prospective reporting of safety incidents concerning drug treatment by approximately 120     primary care physicians or pediatricians during 2015.   "
75709|NCT02294838|"     The aim of this study is to determine the feasibility of demonstrating the following     physiologically-descriptive quantities ('metrics'): the volume of plasma/volume of tissue     (νp), Apparent Diffusion Coefficient (ADC), the volume of extracellular extravascular space     per volume of tissue (νe), and the contrast agent transfer coefficients (Ktrans) pre and post     parotid stimulation in 10 healthy volunteers. Feasibility will be defined as 80% of     volunteers achieving detectable signal changes in pre/post salivary MR images.   "
75669|NCT02295358|"     This study is designed with the intention to further elucidate the effects of omega-3 fatty     acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown     statistically significant lowering of IOP with use of omega-3 fatty acids but have only been     performed in animal models. This study will be the first to attempt replication in human     models. A limited number of studies have shown an increase in tear production/volume as well     as a decrease in the subjective symptoms of dry eye, but more studies are needed to better     define these effects. Better understanding of the effects of this supplement on intraocular     pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of     glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies     about new potential treatment options for these conditions.   "
75670|NCT02295345|"     Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be     effective in a variety of populations including postpartum women, as well as the demonstrated     harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its     efficacy during pregnancy. This project will investigate the efficacy and acceptability of     cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.   "
75671|NCT02295332|"     This is a single center, randomized, double-blind, placebo-controlled, single ascending dose     study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic     effects of single doses of RG7625 in healthy male and female volunteers.      The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated     between two cohorts and each individual within a cohort will receive study drug dosing on     four occasions - in effect giving a four treatment, four period, four-way crossover for each     individual. The minimum duration for each participant is approximately 8 weeks.   "
75672|NCT02295319|"     The present non-blinded randomized controlled trial (RCT) investigates the effect of a     comprehensive discharge model in adult medical patients discharged directly home from an     Acute Admission Unit (AAU). In addition, eligible patients should have, at least, one     hospital admission 12 months prior to index hospitalization and be discharged for further     follow-up by general practitioner, home care nursing or in an out-patient clinic. The model     consists of 3 main steps during the short term stay in the AAU. First, patients are screened     for pre-hospital conditions that might have contributed to the index hospitalization i.e.     functional ability, ongoing treatment including drug treatment, need for additional     assistance to maintain daily living, relatives, and use of e.g. hearing aid, glasses, walker.     Second, at point of discharge there will be a thorough assessment of the discharge plan     focusing on the patients' comprehension of the discharge plan as well as accept of the     suggested treatment and follow-up. Third, within 2 days after discharge the patient will     receive a discharge letter by email or postal mail written in plain language and repeating     the information provided in the discharge summary to the general practitioner. Subsequently,     the patient will receive a telephone follow-up from the research nurse addressing the content     in the discharge letter and possible unresolved issues related to the index hospitalization.     Patients in the control group receives the usual discharge practice in the AAU which does not     include a discharge letter to the patient and telephone follow-up after discharge.      The primary endpoint is number of readmissions within 72 hours and 30 days after discharge.     Secondary endpoints are healthcare service utilization within 30 days after discharge this     includes number of contacts to general practitioner, out-of-hours physicians, emergency     departments and if possible visits by home care nurses. Additionally, Quality-of-Life     measured 30 days after discharge by the questionnaire EQ5D and Patient Experience of the     discharge process is measured 7 days after discharge by a Danish national patient experience     survey - serves as secondary endpoints.   "
75673|NCT02295306|"     Sleep disordered breathing; specifically obstructive sleep apnea (OSA) is a disease affecting     8-12% of the general population and often more than 70% of the bariatric surgical population.     OSA is characterized by the repetitive collapse of the upper airway, causing a reduction or     cessation in airflow and decreases in oxygen saturation. These events are resolved by     arousals from sleep, reducing sleep quality and leading to excessive daytime sleepiness. An     in-laboratory polysomnography (PSG) is the gold standard for the diagnosis of OSA.      Previous studies have established obstructive sleep apnea (OSA) as a potential independent     risk factor for postoperative complications, adverse surgical outcomes, and longer hospital     stays.      Patients with OSA have an increase in postoperative complications, the most frequent being     oxygen desaturation, postoperative atelectasis and increased postoperative pain. Despite the     clear risks, OSA remains under diagnosed with an estimated 25-30% of patients at a high risk     for OSA. It has been suggested that OSA events may be even more frequent post operatively     because of the residual effects of anesthesia and the use of potent pain medications such as     opioids. Postoperatively apneas often go undetected and untreated. The use of supplemental O2     may mask any desaturations and there is no convenient technology to noninvasively monitor     ventilation to detect apnea and hypopnea in post-surgical patients.      New advances in technology and digital signal processing have led to the development of an     impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion,     Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive     measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR). Our     main hypotheses are that the non-invasive, impedance-based RVM monitor will accurately     reflect TV, RR and MV during sleep and will detect apneas and hypopneas accurately.   "
75674|NCT02295293|"     Coronary heart disease and stroke are two main causes of human deaths and is directly related     to increased levels of plasma lipids.High total cholesterol and low high density lipoprotein     cholesterol concentrations are often associated with endothelium dysfunction and     inflammation, which can be followed by atherosclerosis.      Rhus coriaria L. (Rhus) with the public name of Somagh is a plant species in the     anacardiaceae family that is used as a food supplement, spice in Middle East region (Iran,     Turkey and Arabic countries).      In a double blind randomized placebo-controlled clinical trial, the investigators want to     evaluate the effects of Somagh (Rhus coriaria L.) on serum lipid levels of patients with     hyperlipidemia.   "
75675|NCT02295280|"     To determine if the intravenous administration of Metoclopramide and diphenhydramine in     combination can effectively treat headaches in pregnant patients in those refractory to     acetaminophen when compared to codeine   "
75676|NCT02295267|"     Accurate diagnosis of food allergy depends on the identification of the causative allergenic     molecule(s). The proposed study intends to investigate and compare the pattern of IgE     antibody sensitisation in walnut allergic subjects from three different regions of Europe     (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of     novel allergen reagents.   "
75677|NCT02295254|"     The human gut contain a wide range of microorganisms creating the gut microbiome. The     microbiome has great impact on metabolic and immunologic processes and responses. Travelers     who travel to tropical destinations where the intestinal infection risk is high are prone to     microbiome changes. During the current study the travelers will give feces specimen before     and after the travel and their microbiome will be analyzed.   "
75711|NCT02294812|"     In this study, the investigators are testing whether cognitive training can lead to     improvements in speech perception for individuals with hearing loss. Individuals will     complete 20 hours of cognitive training that is designed to improve cognitive abilities such     as short term memory and attention. The investigators predict that cognitive training that     improves the cognitive abilities affected by hearing loss will improve speech perception.   "
78717|NCT02255500|"     The purpose of this study is to evaluate the safety and pharmacokinetics of EXPAREL in     subjects who undergo femoral nerve block with bupivacaine HCl for unilateral total knee     arthroplasty (TKA).   "
75678|NCT02295241|"     The primary aim of this study is to compare traditional muscle function tests with     computerized versions using body-worn motion sensors and video motion analysis of the same     tests. The investigators selected the Timed Up and Go (TUG) test as the investigators primary     variable for this aim with several other function tests (e.g., repeated chair rise, 6-meter     walk, 2-minute walk, Romberg stance, semi-tandem / tandem stance) as secondary variables. The     investigators primary hypothesis is that the computerized versions of the TUG test are highly     correlated (>0.9) with the traditional method, but with comparable or better reproducibility.     Secondary analyses will correlate other function tests with their computerized version, again     with the hypothesis that they are highly correlated and that computerized versions are of     similar or better reproducibility. This analysis will also compare traditional assessments of     balance with a computerized balance method, computerized dynamic posturography.   "
75679|NCT02295228|"     It is essential that serum 25(OH)D changes following surgery be clarified, and the     mechanism(s) underpinning these changes be identified. As such, the overarching hypothesis of     this study is that elective total hip arthroplasty reduces serum total 25(OH)D.   "
75680|NCT02295215|"     The prevalence of Chagas' disease continues high even in the developed countries. Chagasic     Cardiomyopathy with preserved ventricular function is an understudied form of Chagas disease.     Since a majority of patients with these changes progress to dilated form with ventricular     dysfunction with all its serious consequences, it is interesting to better understand the     pathophysiology of the disease at the stage where there electrocardiographic changes and     preserved ventricular function. And besides, search strategies to slow the progress, or even     prevent the chronic phase of the disease. For this reason the investigators will evaluate the     effects of exercise training in patients with Chagas cardiomyopathy without ventricular     dysfunction.   "
75681|NCT02295202|"     Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic     dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to     increase the morbidity associated with metabolic syndrome. This study was designed to     evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic     syndrome.   "
75682|NCT02295189|"     Osteoarthritis is a disabling disease of the joint spaces and has a high impact on society     due to the amount of people who are affected by the disease. Nonoperative management is a     mainstay of therapy in most patients. Ketorolac tromethamine and triamcinolone acetonide     intra-articular knee injections will be compared in a prospective, double-blinded, randomized     trial in subjects with knee osteoarthritis. Subjects will be enrolled from the Orthopaedics     Clinic based on inclusion and exclusion criteria. Intra-articular knee injection of ketorolac     tromethamine or triamcinolone acetonide will be performed under ultrasound guidance. Multiple     outcome measures will be performed throughout the six month period of follow-up. The     investigators predict ketorolac tromethamine will have a longer duration of pain relief when     compared to triamcinolone acetonide. The investigators predict there will be no differences     between the two intra-articular knee injections in terms of function using validated scoring     instruments.   "
75683|NCT02295176|"     Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in     patients with MetS and increased LV mass.      168 patients will be enrolled in this randomized, double-blind, parallel-group,     placebo-controlled trial and treated for 24 weeks.   "
75684|NCT02295163|"     Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of     locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the     main side-effects of ADT. There are no successful and well-tolerable treatment options     available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a     means of interrupting parts of the sympathetic nervous system involved in temperature     regulation.      Objective of this study:      To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus     sham procedure   "
75685|NCT02295150|"     This study is a prospective evaluation of the relationship between lean body weight and     anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous     administration in morbidly obese patients after bariatric surgery.   "
75686|NCT02295137|"     Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm     ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a     minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular     techniques are used to treat patients with more complex pathology by using custom-made     devices and additional stents. In order to accomplish the technical success on advanced EVAR,     with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray     fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target     arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of     contrast and radiation, compared to conventional EVAR. This study is to assess the     feasibility of proper visceral and renal arteries catheterization using a 3D model obtained     from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy,     without contrast injection or angiographic run-offs thus minimizing the contrast use and     patient radiation exposure while achieving procedure success during Advanced EVAR.   "
75687|NCT02295124|"     The study aims to compare the incidence of side effects caused by Oxycodone and     Hydromorphone.   "
75696|NCT02295007|"     Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV)     or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this     study if their parent has the ability to receive and send text messages. Children enrolled in     this study will be observed daily for an eight-day period starting on the day of vaccine     administration, and then continuing over the next 7 days, and then weekly for 42 days. On the     day of enrollment and nightly for the next seven days, the parent will report via text     message what their child's highest temperature is. If fever is present, they will then be     prompted for additional information including other symptoms, antipyretic use and medical     care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents     will be asked via text message about breathing problems, specifically cough, wheezing and     chest tightness. They will also be asked about medications taken and care sought. The purpose     of this study is to assess the feasibility of collecting this data.   "
75688|NCT02295111|"     Chronic pelvic pain (CPP) is a debilitating condition that affects over 1 million women in     the United Kingdom. The annual healthcare costs are estimated at over £150 million. Proven     interventions which include the use of analgesics or hormonal treatments are unsatisfactory     in many cases.      The investigators believe that the meridian balance method (BM) electro-acupuncture (EA)     treatment (which includes a Traditional Chinese Medicine Health Consultation [TCM HC]) may be     helpful in the management of CPP. Studies on the mechanisms of EA have demonstrated an     analgesic effect. A recent individual patient data meta-analysis on the use of acupuncture     for four chronic pain conditions found a small statistically significant effect size when     compared to sham acupuncture. The effect size was larger and statistically significant when     compared to usual care controls. This meta-analysis, and other large studies, suggests that,     in addition to this analgesic effect, the interaction between the patient and the healthcare     provider also plays a role in its effect on painful symptoms.      Our hypothesis is that the meridian BMEA treatment alleviates pain, and improves physical and     emotional functioning, in women with CPP.      The investigators plan to undertake a single centre pilot study to assess the feasibility of     performing a future three-armed randomised controlled, parallel group design trial to     determine the efficacy of the meridian balance method electro-acupuncture (BMEA) treatment in     the management of women with CPP.      The primary objective is to determine whether it is possible to achieve acceptable     recruitment and retention rates within defined inclusion/exclusion criteria.      The secondary objectives are to determine the effectiveness and acceptability to patients of     the proposed methods of recruitment, randomisation, interventions and assessment tools.      The investigators aim to recruit 30 women with CPP in NHS Lothian over a 12-month period and     randomise them to BMEA treatment, TCM HC or standard care (SC). Response to the intervention     will be monitored by validated pain, physical and emotional functioning questionnaires at     weeks 0 (baseline), 4 (end of study) 8 and 12. Focus group discussion to gain feedback on     study experience will be conducted at the completion of the study.   "
75689|NCT02295098|"     The investigators plan to compare the incidence of successful placement of epidural pain     catheters versus paracostal catheters for the control of pain and prevention of pulmonary     complications for adult trauma patients with blunt chest wall trauma resulting in multiple     rib fractures. When a trauma patient has > or = to 3 rib fractures on the same side, is being     admitted to the Surgical ICU, and is encountered within 72 hours from the time of their     injury, they will be eligible for the study. If they (or a proxy) choose to participate,     consent will be obtained and they will randomly be assigned to receive either an epidural or     paracostal catheter for pain control. The aim of the study is to determine if paracostal     catheters are noninferior to epidurals for controlling pain in multisystem trauma patients.     Secondarily the investigators will evaluate success and time of placement of the assigned     intervention and follow the patient throughout their hospital course to compare the success     of analgesia provided by each modality along with any complications and/or benefits of the     two types of catheters.   "
75690|NCT02295085|"     The Fernald Community Cohort consists of the 9782 persons who were enrolled in the Fernald     Medical Monitoring Program (FMMP) (1990-2008). The initial comprehensive examination     conducted as part of the Fernald Medical Monitoring Program (FMMP) began in the autumn of     1990. The FMMP provided 9,782 initial examinations and 42,775 re-examinations. An extensive     computerized database and biospecimen repository was created to provide research resources     for future studies. All questionnaire, examination and diagnostic procedure data collected     from the FMMP were [coded by certified medical record coders,] double entered with     verification into a SAS database on site of the examinations. Cryo-preserved blood and urine     samples were collected at enrollment and at various intervals throughout follow-up. At the     first examination three 1-ml aliquots of whole blood, plasma, serum, urine and urine with     buffer were obtained from each participant (15 aliquots per person) for future analyses.     Additional whole blood and serum was obtained in 1996-1997 and 2006-2008. Specimens have been     stored in -80 degree freezers; over 160,000 biospecimens are in the archive. Since 1994, the     FCC has had an established procedure for sharing data and biospecimens with qualified     researchers. Both the policy and application forms can be found at     www.eh.uc.edu/fmmp/research.   "
75691|NCT02295072|"     The ActiveBrains project aims to examine whether a 5-months physical exercise program has     benefits on cognition and brain, as well as on selected physical and mental health outcomes     in preadolescent overweight/obese children.   "
75692|NCT02295059|"     The investigators study aims to determine biological changes associated with a low vs high     dose of omega 3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), over 12     months in women at risk for recurrent breast cancer. The objectives of the trial are to     develop mammary epithelial, adipose tissue specific markers of exposure and response to omega     3 fatty acid supplements that can be carried forward into definitive intervention trials of     omega 3 fatty acids for breast cancer prevention. The investigators will randomize 80     subjects with hormone receptor negative, HER-2/neu overexpression positive or negative breast     cancer to either a high or low dose of omega 3 fatty acids. Using fine needle aspiration to     procure cellular samples of breast epithelial and adipose tissue, the investigators will     determine the effects of omega 3 fatty acids on mammary specific biomarkers of response.   "
75693|NCT02295046|"     This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium     Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate     and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland     in Healthy Male and Female Volunteers under Fasting conditions.   "
75694|NCT02295033|"     Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase III     trial is studying the effect of an extra dose of radiation therapy (Boost dose) after breast     conserving surgery and 50 Gy adjuvant external beam radiotherapy to see how well it works     compared to no further therapy in treating women with early breast cancer that has been     surgically removed.   "
75695|NCT02295020|"     The objectives of the study are 1.) to evaluate pain relief following the application of the     Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more     effective at reducing inflammation than standard of care alone using synovial fluid cytokine     analysis and validated outcome measures.   "
75697|NCT02294994|"     The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa     inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which     include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary     thrombus, SYNTAX score>26,chronic total occlusion disease. The primary endpoint is all-cause     mortality. Secondary endpoints are incidence of major bleeding and the rate of site access     complication.   "
75698|NCT02294981|"     The purpose of this study is to determine the best dosing strategy when using Excimer Laser     to treat plaque-type psoriasis. In this study, half of the body's psoriasis will be treated     with a new dosing strategy, and the other half will be treated with the conventional method.     We hope to show that the new dosing strategy will result in faster improvement of psoriasis.   "
75700|NCT02294955|"     The objective is to compare the efficacy of 2 treatment strategies, catheter ablation of     atrial fibrillation versus optimized pharmacological therapy, in patients with symptomatic     atrial fibrillation.      It is a randomized, prospective, controlled, open-label multicentre, parallel-group study     including 116 patients. Inclusion criteria are patients aged 30-70 years with symptoms     related to atrial fibrillation and who have failed or been intolerant to at least one     anti-arrhythmic drug, with at least one atrial fibrillation episode documented on ECG during     the previous 12 months and at least one symptomatic episode during the previous 2 months or     at least 2 symptomatic episodes of persistent AF in the previous 12 months.      Main exclusion criteria are patients who have tested 2 or more anti-arrhythmic drugs for     rhythm control, uncontrolled hypertension, valvular disease requiring anticoagulation,     planned valve surgery within 2 years, contraindication to treatment with anticoagulants,     heart failure, left atrial diameter > 60 mm, unstable angina or acute myocardial infarction     within the last 3 months, cardiac revascularization procedure within the last 6 months, prior     cardiac surgery or planned cardiac corrective surgery within 1 year, prior AF ablation     procedure.      The primary endpoint is general health-related quality of life at 12 months follow-up. The     main secondary endpoints are morbidity and mortality as composite outcome, cardiovascular     hospitalization, symptoms, heart failure, left atrial and ventricular function and diameters,     exercise capacity, health care economics, rhythm, atrial fibrillation burden, successful     versus failed treatment, safety and cross-overs over time.      Patients will receive a cardiac monitor, implanted subcutaneously, which will monitor the     heart rhythm during a two month Run-in period, for the definition of the basic atrial     fibrillation burden. Patients will be randomly assigned to an antiarrhythmic drug (for rhythm     or rate control) or to left atrial catheter ablation. Evaluation of outcome is at 12, 24, 36     and 48 months of follow-up, while health economy will be evaluated at 24 and 48 months of     follow-up.. In case of documented disease progression or unacceptable toxicity, subjects will     be switched to the alternative regimen. The main statistical analysis of the primary endpoint     will be based on the intention-to-treat population. The trial duration is 48 months.   "
75701|NCT02294942|"     A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of     add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina     pectoris.   "
75702|NCT02294929|"     Prospective and explorative clinical study. The objective is to assess the clinical efficacy     of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with     longstanding persistent atrial fibrillation (AF) at one year follow up.      44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF     duration longer than one year, who have not previously undergone an AF ablation procedure,     and have symptoms related to AF corresponding to at least European Heart Rhythm Association     (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or     class I or III antiarrhythmic drug.      Excluded are those with congestive heart failure with New York Heart Association (NYHA) class     3 or more, left ventricular ejection fraction < 40%, left atrial diameter ≥ 60 mm,     significant valvular disease or planned cardiac intervention within next 12 months, and     conventional contraindications for AF ablation procedures.      Patients will be screened with echocardiography and response to electrical cardioversion.     Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm.     Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon     ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping     catheter.      All patients will be subject to electroanatomical voltage mapping during sinus rhythm for     demonstration of extent of atrial myocardial lesions after ablation.      Patients will be followed every third month up to one year after the ablation procedure.     Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9     and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA     score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation     procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at     12 months follow up.      Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary     end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according     to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse     Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of     freedom from AF, complications, hospitalization and Health economics.   "
75703|NCT02294916|"     The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller     laryngoscope during pediatric resuscitation with and without chest compressions.   "
75704|NCT02294903|"     To assess the early histological outcomes of tissue ablation, adverse events and     genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar     device to treat localized prostate cancer in men with clinically significant prostate cancer.   "
75705|NCT02294890|"     At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients     will be checked for signs of fibrosis diathesis. This will be done by examining their hands     for Dupuytren's nodules and contractures and recording risk factors associated with increased     severity and risk of recurrence of Dupuytren's contracture. These include family history,     bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose     disease, first ray involvement, multiple ray involvement and ectopic fibromatosis.      This way, two groups of patients will be identified: those with and those without signs of     fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and     6 months will be retrieved in the charts, the ROM at 12 months will be measured at that time.     Also, additional procedures performed to increase ROM postoperatively will be retrieved from     the charts (e.g. continuous passive motion, mobilization under anesthesia). Other causes for     knee stiffness will have to be recorded, since these will be the most important exclusion     criteria.      In the patients with clear signs of finger contractures, any impression of increase of     contracture over the past 12 months will be recorded.   "
75706|NCT02294877|"     The objectives of this program are: to characterize and describe the Mucopolysaccharidosis IV     type A (MPS IVA) population as a whole, including the heterogeneity, progression, and natural     history of MPS IVA; to evaluate the long-term effectiveness and safety of Vimizim®,     including, but not limited to, the occurrence of serious hypersensitivity reactions,     anaphylaxis, and changes in antibody status; to help the medical community with the     development of recommendations for monitoring MPS IVA patients and reports on patient     outcomes to optimize patient care; to collect data on other treatment paradigms, and evaluate     the prevalences of their use and their effectiveness; to characterize the effects and safety     of Vimizim treatment 5 years from enrollment in the Registry for patients under 5 years of     age; to monitor pregnancy exposure, including maternal, neonatal, and infant outcomes; and to     monitor patients who have completed the MOR-005 and MOR-007 clinical trials. These patients     will be encouraged to enroll in the applicable Registry Substudy and will be monitored using     the MOR-005 and MOR-007 assessment schedules, respectively.   "
75707|NCT02294864|"     It is estimated that nearly 27 million US adults have osteoarthritis (OA) and suffer from     pain . Pulsed Radio Frequency (PRF) is one method that has been successfully used in     treatment of various etiologies of pain. However there are limited studies and research that     prove its effectiveness in treating articular pain. The proposed study's primary aim is     determining if PRF is an effective treatment for chronic osteoarthritic knee pain. This study     hypothesizes that PRF has analgesic properties immediately after treatment and at least 3     months afterwards compared to control treatment with physical therapy.      Additionally this research project addresses several other objectives including:        1. Provide a controlled study to determine the effectiveness of PRF for intra-articular          pain        2. Determine how effective PRF is 1 month and 3 months after treatment for articular pain.        3. Further scientific evidence on the overall effectiveness of PRF        4. Provide evidence that PRF likely has other mechanism of action besides direct nerve          stimulation of inhibitory pain pathways.        5. Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee          osteoarthritis.   "
75712|NCT02294799|"     Background: Among the instrumental devices that have been proposed over the years to     integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging     techniques are the most studied, showing that magnetic resonance imaging (MRI) is the     technique most need to describe the anatomy of the TMJ and to evaluate the correlation of     imaging findings with the clinical diagnosis . Despite the amount available studies on the     use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that     evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of     nonspecific mandibular mobilization about the positioning of the articular disc by MRI in     individuals with TMD diagnosis of anterior disc displacement with and without reduction     according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).     Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline     and after each treatment session, the quality of life of individuals with TMD at baseline,     immediately, three and six months after the treatment sessions by the World Health     Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific     Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed     three times a week during four weeks. Metodology: This is a randomized, placebo controlled,     blind study designed to assess the effects of techniques nonspecific mandibular mobilization     x placebo. Individuals will be randomized and divided into two groups: Group A (intervention)     and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted     through the use of MRI, will be considered the primary outcome and, as a secondary outcome     will be assessed the quality of life, pain and function after treatment. The adherence of the     data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as     mean values and standard deviation. Two-way repeated measures analysis of variance with     Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance     level is adjusted p ≤ 0.05.   "
75713|NCT02294786|"     Diarrhoea is the most commonly reported adverse events (AE) associated with Lapatinib     treatment, and is also commonly associated with Capecitabine treatment. Although these events     are generally mild to moderate in severity, diarrhoea adversely affects the tolerability of     cancer treatment, and in severe cases diarrhoea has the potential to affect the efficacy of     treatment due to poor compliance, or treatment interruption or withdrawal. The efficacy of     Octreotide in the management of cancer treatment-associated diarrhoea has not been     extensively evaluated in large, well-controlled studies. This is a randomised, multi-centre,     open-label Phase II study in subjects with Human epidermal growth factor receptor 2     (HER2)-positive metastatic breast cancer which has progressed following prior therapy, which     must have included anthracyclines and taxanes and therapy with Trastuzumab in the metastatic     setting. This study is not placebo controlled, and there is no active comparator. The study     will evaluate whether the prophylactic use of Octreotide Long Acting Release (LAR) offers a     clinically meaningful benefit by reducing the frequency and severity of diarrhoea associated     with treatment with Lapatinib and Capecitabine. Study completion for a subject will be     defined as the completion of 24 weeks of treatment with Lapatinib and Capecitabine, or     progression of cancer or the death of the subject during treatment, whichever occurs first.     Approximately 140 subjects will be randomized out of which 70 will receive octreotide and 70     will receive no Octreotide   "
75714|NCT02294773|"     The aim of this study is to assess the impact of the timing of intrauterine insemination     (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home     ovulation predictor kits, on pregnancy rates per treatment cycle. The study will take place     at the offices of Midwest Fertility Specialists and include patients who have been     independently recommended by their primary physician to undergo ovulation induction with     clomiphene citrate (CC) or letrozole and IUI as therapy for infertility.   "
75715|NCT02294760|"     A recent randomised, controlled, crossover study has shown that sacral nerve stimulation     (SNS) significantly reduces symptoms and improves quality of life of highly selected patients     with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with     consistent changes in rectal sensitivity and biomechanical wall properties.      The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on     symptoms and quality of life in patients with IBS in a randomised, placebo-controlled,     crossover study.   "
75716|NCT02294747|"     Trochanteric fractures represent about half of the hip fractures (with femoral neck fractures     as the other half). Trochanteric hip fractures are almost always treated surgically with     internal fixation of the fracture. However there is a debate ongoing for what is the     appropriate implant to use. For stable fracture patterns the evidence seems to be in favor of     the sliding hip screw, but for the unstable fractures it is more unclear whether to use a     intramedullary nail or sliding hip screw with or without a lateral support plate (TSP). The     role of the TSP in clinical use remains unclear and very little has been published about     this, but it is believed to be an important contributor of stability to the sliding hip screw     construct. We are planning a randomized controlled trial on trochanteric hip fractures to     establish a method for implanting the tantalum markers, to observe the fracture healing     process and to further investigate the role of the TSP.   "
75717|NCT02294734|"     The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition     to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic     Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety,     tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks     including screening, treatment period and a follow up visit. Subjects will receive once daily     study treatment administration starting on Day 1. Study is planned to recruit approximately     120 subjects such that approximately 100 subjects complete the study.   "
75718|NCT02294721|"     The aim of this study was to compare four different CPR feedback devices to standard BLS in     terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators     hypothesis was that there would be no difference between CPR methods in terms of chest     compression quality parameters.   "
75719|NCT02294708|"     The purpose of this study is to evaluate whether postoperative postures influence persistent     sub-foveal fluid after scleral buckle surgery   "
75720|NCT02294695|"     To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after     starting empirical antibiotic therapy in critically ill patients, to predict appropriate or     inappropriate antibiotic treatment.   "
75758|NCT02294201|"     The primary objective of the study is to demonstrate and quantify the protective efficacy     (PE) of spatial repellent products in reducing the incidence of malaria infection in human     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between     intervention and control arms.   "
75760|NCT02294175|"     This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers     who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2     applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an     8 day study period.   "
75721|NCT02294682|"     GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including     ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized,     multicenter, open-label, dose ranging study designed to inform the optimal oral dose of     GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with     uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned     to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944.     Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1)     Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be     approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in     each treatment arm) will complete the study if both arms remain active throughout the study.   "
75722|NCT02294669|"     This is a prospective, exploratory study to verify intra-operative handling and safety and to     collect preliminary short-term safety and efficacy data of the Turris® Facet Fuser, a small     bioresorbable device for the immediate immobilization of the facet joint.      Patients eligible for study enrollment will present with degenerative lumbar spinal diseases     involving the L4/L5 segment and requiring spinal fusion.   "
75723|NCT02294656|"     This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs.     intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic     cystoid macular edema (CME). Twenty consented patients with acute CME after     phacoemulsification cataract surgery with posterior chamber intraocular lens implantation     (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three     monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3     months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically     in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening     of CME, combined with any of the following:        -  Any increase in spectral domain ocular coherence tomography (OCT) central macular          thickness (CMT)        -  Any observable fluid on OCT        -  Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA).      Patients will be followed monthly through 12 months.   "
75724|NCT02294643|"     The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in     patients with CKD or DM after DES implantation.   "
75725|NCT02294630|"     Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of     mortality and morbidity in preterm infants. Intratracheal instillation, the only approved     means of surfactant delivery, requires endotracheal intubation and mechanical ventilation     with their attendant risks. Interventions that decrease need for intubation and mechanical     ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway     pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are     increasingly being used for initial respiratory support in preterm neonates with RDS to     improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising     concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar     recruitment while obviating the risks of intubation and mechanical ventilation. The     investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in     preterm infants undergoing NIV is safe and feasible and will result in short-term improvement     in oxygenation and ventilation. The objective of this proposal is to perform a single-center     unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of     RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.   "
75726|NCT02294617|"     The goal of this study is to get information from current smokers about how they feel towards     both the electronic cigarette (e-cigarette) and the nicotine oral inhaler. This will include     beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people stop     smoking.   "
75727|NCT02294604|"     Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The     traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or     chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61%     ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable     antiseptic effect. The investigators perform a randomized controlled trial to compare the     antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with     povidone-iodine and chlorhexidine solutions.   "
75728|NCT02294591|"     This trial investigate add-on treatment with 3 g NAC vs. placebo in 20 weeks in patients     suffering from bipolar depression. The primary outcome is MADRS-score, and the secondary     outcomes are other psychometric evaluations oxidative stress biomarkers in urine.   "
75729|NCT02294578|"     The investigators plan to recruit patients for a prospective study in patients in need of     evaluation for lung lesions suspicious for cancer. Saliva samples will be collected before     diagnostic evaluation including biopsy with subsequent blinded examination of the salivary     markers without knowledge of the disease status. This prospective recruitment with     retrospective blinded evaluation or PRoBE design satisfies the highest standards recommended     by the National Cancer Institute for biomarker development. This process limits the selection     bias that can confound retrospective studies. As the primary endpoint, a pre-specified     multi-marker panel will be evaluated based on the combination of sensitivity and specificity.     In addition, seven pre-specified individual candidate mRNA cancer markers and six internal     reference or housekeeping genes will be evaluated. The performance of new multi-marker     panels will also be assessed and compared with the prior pre-specified model based on     sensitivity and specificity combinations as well as the area under the receiver operating     characteristic curve.   "
75730|NCT02294565|"     The purpose of this Phase 1 portion of this clinical research study is to find out what dose     of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to     be removed during surgery (a standard of care surgery referred to as a Sentinel Lymph Node     Biopsy procedure) in patients diagnosed with breast cancer.      The purpose of the Phase 2 portion of this clinical research study is to find out if giving     dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can     help surgeons localize the lymph nodes that need to be removed in patients diagnosed by     breast cancer.   "
75759|NCT02294188|"     The primary objective of the study is to demonstrate and quantify the protective efficacy     (PE) of spatial repellent products in reducing the incidence of malaria infection in human     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between     intervention and control arms.   "
75731|NCT02294552|"     This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as     graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in     patients with different risk of GVHD. The risk-adapted strategy involves using single-agent     cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide     with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem     cells and mismatched bone marrow.   "
75732|NCT02294539|"     The purpose of this study is to investigate which combination therapy is more effective for     improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II     receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics   "
75733|NCT02294526|"     Work hypothesis      A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.   "
75734|NCT02294513|"     There is a strong connection between hearing loss and cognitive impairment, particularly     dementia, in old age. Worldwide, dementia affects approximately 5% of persons over the age of     65 years. Hearing loss is even more prevalent in old age, affecting an estimated one third of     persons over the age of 65 years. Thus, there is likely a large degree of overlap between the     impairments. Indeed, this overlap may influence older adults' everyday functioning,     communication, social engagement and quality of life, as well as influencing the well-being     of their family caregivers. This project will examine whether patients with hearing loss and     Alzheimer's disease, the most common form of dementia, derive benefit the from hearing aids     prescribed and fit to them following current best practice procedures in a geriatric     audiology clinic. For the first time, a formal evaluation of the potential benefits of     hearing aids for the patients' family caregivers will also be conducted.   "
75735|NCT02294500|"     The study will collect the clinical and biological data of the patients, the investigators     could further analyse and identify the risk factors and optimize clinical treatment method.     Besides, population-based healthy people with informed consent are also collected.   "
75736|NCT02294487|"     This study will collect blood samples from healthy volunteers and volunteers with multiple     myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae B (HIB),     and/or meningococcus vaccines.      The main goal of the study is to start to identify differences in the immune response between     multiple myeloma patients and people who don't have multiple myeloma. We hope this will     provide important information about the best way and time to vaccinate multiple myeloma     patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus .   "
75737|NCT02294474|"     Primary Objective:      To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c)     change from baseline to Week 26 in patients with type 2 diabetes mellitus (T2DM) also using     insulin glargine.      Secondary Objectives:      To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status     and antibody titers at baseline and during the course of the study; To assess the     relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of     SAR342434 and Humalog on: proportion of patients reaching target HbA1c <7.0% and ≤6.5%,     fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin     dose.      To assess safety of SAR342434 and Humalog.   "
75738|NCT02294461|"     Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific     Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with     progressive metastatic prostate cancer who have failed androgen deprivation therapy.   "
75739|NCT02294448|"     Qishe Pill (Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China), composed of     processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae,     Ovientvine, and Calculus Bovis Artifactus, has been developed and spread in use into clinical     settings in 2009. As individualization has become the trend of modern medicine, a     personalized medicine of Qishe Pill should be documented and practiced with various patients     according to the ancient TCM system, a classification of personalized constitution type,     which has been established to determine predisposition and prognosis to diseases as well as     therapy and life-style administration. Therefore, we describe the population pharmacokinetic     profile of Qishe Pill and compare its extent of metabolism in the 3 major Constitution Type     (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges of     individualized and standardized Traditional Chinese Medicine into clinical practice.   "
75740|NCT02294435|"     The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use     of the thoracic bifurcation and the visceral manifold or the unitary device to repair     thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent     of the study is to assess safety and preliminary effectiveness of the device. Additionally,     the study will assess technical success and treatment success at each follow-up interval.   "
75741|NCT02294422|"     This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is     traditionally used for identifying epidural space, is a better method for providing safe cuff     pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the     use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with     airway damage.      The study hypothesis states that both the loss of resistance syringe method and the pilot     balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.   "
75754|NCT02294253|"     The investigators will randomize 50 opioid-dependent participants who have initially failed     outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a     weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day     stabilization and twice weekly during taper phase, and all patients who successfully complete     the detoxification will be offered induction onto XR-NTX. All participants will receive     weekly therapy with a study psychiatrist. All participants will receive open-label     medication. The primary outcome of this study will be percentage of patients successfully     inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or     dropout.   "
75756|NCT02294227|"     The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus     placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration     with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and     to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite     current or previous NSAID, non-biologic DMARD or biologic anti-TNFα therapy   "
75742|NCT02294409|"     Social anxiety represents one of the most prevalent comorbid conditions in schizophrenia and     related psychosis. Schizophrenia patients with comorbid social anxiety often exhibit impaired     social functioning, an increased risk for relapse, and higher rates of suicide. Social     anxiety is a treatable condition but has, in the context of psychosis, received only scant     attention thus far. There is strong evidence that cognitive-behavioral therapy (CBT) for the     treatment of social anxiety is very effective, whether it is delivered individually or in a     group setting, and studies have shown that a group setting is more effective than individual     therapy. Providing a CBT intervention for social anxiety represents an effective way to     empower people with this illness.      The investigators have conducted a preliminary study using an uncontrolled design to assess     feasibility and initial benefits of a new manualized group CBT intervention for social     anxiety specifically adapted for people with psychosis. The investigators observed a     significant reduction in social anxiety symptoms across three groups of first episode     psychosis (FEP) participants (n=29) following completion of this 13-week intervention, and     observed large effect sizes confirming a significant positive influence of this intervention.     The investigators now propose to conduct a randomized controlled trial to fully assess the     efficacy of this intervention. The main objective of this research proposal is to contrast     the impact of a CBT intervention for the treatment of social anxiety in first episode     psychosis with another control condition involving computer assisted cognitive remediation     therapy (CACRT). Both interventions will be offered in a group setting, and will therefore     have the exact same parameters. A secondary objective of this study is to examine the impact     of reduced social anxiety on measures of clinical and functional outcome.      For this trial, 120 patients with recent onset psychotic disorder (defined as within 5 years     from their first episode of psychosis) and with social anxiety will be clinically assessed.     These participants will be recruited from five different first episode psychosis programs in     the Montreal area and referred by their treatment team. They will then be randomly assigned     to either the CBT or CACRT conditions. Both interventions will involve 13 weekly group     sessions. At the end of group interventions and at two follow-ups (3-month & 6-month), the     presence and severity of social anxiety symptoms will be assessed. It is hypothesized that     compared to the CACRT group, individuals receiving the CBT intervention will show a reduction     in symptoms associated with social anxiety (as determined with multiple self-report and     clinician rated measures). This effect will be maintained at follow-ups. In addition, the     investigators also hypothesize that the CBT group will show better clinical outcome, defined     as the length of symptomatic remission at follow-ups. For functional outcome, they will show     significant improvement on a self-report measure a clinician-rated measure of recovery. This     study will be one of the first to specifically target social anxiety in people with psychosis     using a psychosocial intervention. As such, it will tackle an important problem that is     interfering with recovery and with the actualization of functional roles.   "
75743|NCT02294396|"     The objective of the study is to evaluate the safety and efficacy of add-on therapy with     anticholinergics in patients with overactive bladder (OAB) on mirabegron.   "
75744|NCT02294383|"     The clinical study includes investigation of the outcomes of surgery for biomechanical     restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative     treatment/management, identification and investigation changes of pelvic floor muscle     contractions and their significance in characterization of pelvic floor conditions,     assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.   "
75745|NCT02294370|"     This study aims at improving the prediction of type 2 diabetes among high-risk individuals by     examining glucose excursion patterns in subjects with impaired glucose tolerance. In     addition, this study will show whether the currently used diagnostic test could be replaced     by an easier and less expensive method.   "
75746|NCT02294357|"     The purpose of this Phase II study is to evaluate the safety and effectiveness (good and bad     effects) of carfilzomib given as a 30-minute infusion and at a dose of 70 mg/m2 to treat     patients with multiple myeloma (MM), who are currently showing progressive disease     (worsening) and had progressed (did not respond to treatment) within 8 weeks of receiving     treatment with 27mg/m2 of carfilzomib. Carfilzomib is approved by the U.S. Food and Drug     Administration (FDA) to be used only in certain U.S. patients with relapsed and refractory     multiple myeloma that have tried and failed other therapies. Carfilzomib is considered an     investigational drug for this study because the dose and regimen included in this study are     different from the FDA approved carfilzomib regimen. Carfilzomib is a type of drug called a     proteasome inhibitor. Carfilzomib is thought to work by preventing breakdown of abnormal     proteins in cells, causing the cells to die. Cancer cells are more sensitive to these effects     than normal cells. Carfilzomib has been previously given to more than 1800 people in clinical     trials.   "
75747|NCT02294344|"     The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with     antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).   "
75748|NCT02294331|"     Lead survivability will be summarized.   "
75749|NCT02294318|"     This pilot study goal is to compare two different treatments to help HIV positive patients     reduce their concurrent drinking and non-injection drug use.   "
75750|NCT02294305|"     This placebo-controlled study is designed to determine the efficacy, safety, and tolerability     of vortioxetine in the treatment of adults with Major Depressive Disorder (MDD) that is     comorbid with Social Anxiety Disorder (SAD). Half of the subjects will be randomized to     receive vortioxetine and the other half will receive placebo.   "
75751|NCT02294292|"     Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with     cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of     complications in liver disease. The purpose of this prospective, randomized controlled trial     is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular     diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction,     worsening cardiac function, and mortality).   "
75752|NCT02294279|"     Nitric Oxide is recognized as a biological marker for many chronic airway diseases. It has     been standardised for clinical use indicating airway inflammation.      In clinical practice, FeNO can aid confirmation of an asthma diagnosis and can indicate the     degree of steroid-responsiveness. This can help guide physician decisions on the initiation     of inhaled corticosteroid (ICS) therapy, or adjustment of ICS therapy.      Therefore, FeNO measurement could be particularly useful to confirm an asthma diagnosis in     patients with non-specific respiratory symptoms (≥ 6 weeks of cough and/or wheezing and/or     chronic dyspnoea) and to assess how likely they are to benefit from corticosteroid treatment.      This study will assess the suitability of FeNO to predict ICS responsiveness in patients with     non-specific respiratory symptoms.      Additionally, we would like to determine the suitability of FeNO as a diagnostic tool for     asthma in comparison to conventional predictors, e.g. spirometry.   "
75753|NCT02294266|"     The purposes of this study are 1) to evaluate the pharmacological effects after oral     coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of     mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.   "
75755|NCT02294240|"     A nutrition trial which is based on the evidence that multivitamins & micro nutrients     provided during pregnancy in malnourished women will improve neonatal birth weight. There     will be two arms. Arm one will provide energy dense biscuits to pregnant women with BMI <20 &     gestational age less than 14 weeks. The other arm with same criteria will be provided with     wheat flour, oil, iron & folic acid. Neonatal birth weight is the primary outcome of interest     but maternal weight gain, maternal hemoglobin & ferritin levels and palatability of biscuits     will also be assessed.   "
75761|NCT02294162|"     Pain is an unpleasant sensory experience associated with actual or potential tissue damage.     Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it     is the most important factor related to patient discomfort after surgery. Adequate pain     management, ideally resulting in the complete absence of postoperative pain, not only     provides comfort to patients, but may also contribute to improved healing and a reduction in     the incidence of postoperative complications. Inadequate postoperative analgesia has been     shown to contribute to adverse outcomes, including, but not limited to, immunosuppression,     hyperglycemia, poor rehabilitation, and progression to chronic pain.   "
75762|NCT02294149|"     The purpose of this study is to determine whether administration of mammalian Omega 3     FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due     to chemotherapy.   "
75763|NCT02294136|"     End-stage liver disease, predominantly due to hepatitis C virus (HCV) infection, is one of     the leading causes of death in person living with HIV infection. While HCV is curable and     recent advances in treatment have increased the rates of cure, few patients with HIV and HCV     are being treated to cure HCV. Based on formative research, the investigators developed the     Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C).     PREP-C is a clinical interview that healthcare providers of diverse disciplines can be     trained to administer. It provides an assessment of a client's psychosocial readiness to     begin HCV treatment and identifies domains of functioning which require intervention to     improve treatment readiness. PREP-C (www.prepC.org) is also a telemedicine resource for     health care providers. Under this protocol, the existing PREP-C clinical interview (or     assessment) is incorporated with a behavioral intervention. This study tests the integrated     assessment-behavioral intervention to increase HCV treatment initiation among HIV-co-infected     patients. The assessment-behavioral intervention under this protocol is conducted in two     phases, an Intervention Development phase and a Pilot Randomized Clinical Trial (RCT) phase.      Findings from this vanguard study will inform the design parameters of a larger, more     rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based     assessment and intervention package is designed to be scalable and can be disseminated     through the live PrepC.org web site. The proposed study is innovative in that it seeks to     develop the first web-based intervention for health care providers to use to increase HCV     treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health     impact by providing needed structured resources for health care providers to increase rates     of HCV treatment initiation in HIV/HCV-co-infected persons, thereby reducing mortality due to     end-stage liver disease.   "
75764|NCT02294123|"     Objective. To evaluate the effect of the intake of two types of whole corn tortilla and one     traditional tortilla on glycemic index (GI) and insulinemic index (InIn) in adults with     diabetes, or overweight or clinically healthy.      Material and methods. Type crossover clinical trial in adults 20-69 years. Three groups of     participants will be included for each category (n = 27 in each group): 1) adults with     diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and     insulinemic index will be measure for each group of participants given in random order the     following foods: 1) a whole corn tortilla (white criollo corn= 5.3% fiber), 2) a whole corn     tortilla (white hybrid corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4)     white bread (reference food containing 2.2% of fiber). For the calculation of GI and InIn     will be follow the FAO methodology. For the evaluation of each food left the range of 1     week.   "
75765|NCT02294110|"     Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia     failure. However, that opinion was not determined in a trial. Thus the investigators aimed to     investigate the effect of diabetes mellitus on spinal anesthesia.   "
75766|NCT02294097|"     The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains     unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients     with standard approach which allograft biopsy was performed only when indicated.   "
75767|NCT02294084|"     The obesity epidemic has resulted in an exponential increase in obesity-related disorders     including type 2 diabetes, dyslipidemia and cardiovascular disease. The associated morbidity     and mortality have major consequences both at an individual as well as on the socioeconomical     level. Thus, the development of novel therapies aimed at reducing the development of obesity     is highly warranted. Brown adipose tissue (BAT) recently emerged as a novel player in energy     expenditure in humans as it combusts fatty acids towards heat. Interestingly, obese subjects     have less BAT as compared to lean subjects and activation of BAT by means of intermittent     cold exposure reduces fat mass. Therefore, BAT is considered a promising novel target to     reduce obesity and associated disorders. As cold exposure is not the most desired therapeutic     strategy for humans, current pre-clinical research focuses on pharmacological activation of     BAT.      Interestingly, the investigators have recently shown that central agonism of the receptor for     the incretin hormone glucacon-like peptide-1 (GLP-1) results in activation of BAT in mice.     One of the currently used anti-diabetic drugs that enhances GLP-1 availability is Sitagliptin     (STG). Interestingly, STG also reduces body weight and plasma triglyceride (TG) levels in     type 2 diabetes mellitus (T2DM) patients. The mechanism underlying these beneficial metabolic     effects is currently unknown. The investigators hypothesize that STG enhances BAT activation,     thereby increasing energy expenditure and combustion of TG-derived fatty acids, resulting in     lowering of plasma TG levels and body weight.      To this end, the investigators will perform a randomized double-blinded placebo-controlled     study in which 30 male Dutch Caucasian adults aged 35-50 years with moderate obesity and     pre-diabetes are included. Subjects will be treated for 12 weeks with STG or placebo. Before     and after treatment, the investigators will determine BAT volume and total BAT activity via     cold-induced 18F-FDG PET-CT scans, resting energy expenditure via indirect calorimetry using     ventilated hoods, body weight, and body composition via DEXA scan. Furthermore, before and     after treatment, blood samples will be taken to measure plasma lipids, glucose and insulin     levels.      This study will offer valuable novel insight in the effects of pharmacological activation of     BAT in human obese subjects.   "
75768|NCT02294071|"     This study will examine in detail the immediate effects of three common treatments given to     children with fevers to lower their temperature. Each child will be given either ibuprofen,     acetaminophen, or a combination, and their temperature monitored at five-minute intervals.     The temperature-lowering effects of each treatment will be compared to evaluate which is most     effective.   "
75769|NCT02294058|"     The purpose of this study is to determine whether RPC1063 is effective in the treatment of     relapsing multiple sclerosis (RMS).   "
75770|NCT02294045|"     Clinical-noninvasive recording of sounds from the knees through a brief loaded range of     motion. Description in phase 1 analytic but descriptive as well in phase 2. No samples other     than a sound recording. The device is known microphone attached to the skin of the knee with     elastic material. Sound recorded and analyzed on a lap top computer with Adobe software.   "
75771|NCT02294032|"     The purpose of this study is to understand the role of specific B cells in activating or     repressing an anti-allograft immune response after kidney transplantation. In this study,     blood will be collected from kidney transplant patients during different timepoints, prior to     and after their transplant. Knowledge gained from study findings will be used to develop     therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of     long-term graft loss in kidney transplant patients.   "
75772|NCT02294019|"     This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in     which subjects will use the product after making a purchase decision about ibuprofen 400 mg     caplets based only on their reading of the Drug Facts Label (DFL) and other information on     the package.   "
75773|NCT02294006|"     Abnormal PI3K-Akt-mTOR (mammalian target of rapamycin) pathway signaling and autocrine     activation of the mTOR pathway, mediated through insulin-like growth factor 1 (IGF1), has     been implicated in the proliferation of pNET ( primitive neuroectodermal tumor) cells.     Everolimus ,an mTOR inhibitor (a central regulator of growth/proliferation, cellular     metabolism and angiogenesis) has shown antitumor benefit in pNETs alone and in combination     with Octreotide LAR in RADIANT-1 and RADIANT-3 studies.      Despite EVE-based phase II/III trials improve progression-free survival (PFS) for pNETs, they     are limited to significantly prolong overall survival (OS). Metformin has recently shown some     anti-cancer activity, both in vitro and in vivo studies by antisecretory properties to     decrease insulin and IGF1 levels; and by antitumor effect due to AMPK (adenosine     monophosphate kinase) activation and consequently inhibition to TSC1(tuberous sclerosis     complex 1) -2/mTOR complex, mediated to LKB1 oncogene expression. The investigators     retrospective experience, despite in a limited group of pWDNET, highlights the role of MET to     improve clinical benefit in diabetic pts receiving EVE-OCT (octreotide) combination.      This study will investigate the antiproliferative potential of MET in combination with EVE     and OCT in pWDNETs. MetNET1 prospective trial (EudraCT 2014-000888-41) may be helpful to     either confirm or discard these preliminary findings.      The main objective of this study is to evaluate progression free survival rate at 12 months     of treatment. The secondary objectives are safety, overall survival, response rate     evaluation.      A sub-study analysis will evaluate circulant biomarkers levels (IL 6, IGF1) in blood samples.   "
75774|NCT02293993|"     To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously     to Japanese patients with acute myeloid leukemia (AML).   "
75775|NCT02293980|"     PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD)     of PT2385 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2385 Tablets in patients     with advanced clear cell renal cell carcinoma (ccRCC).      PART 2: The primary objective of this study is to identify the MTD of PT2385 Tablets up to     the RP2D, in combination with nivolumab, in patients with advanced ccRCC.      PART 3: The primary objective of this study is to identify the MTD of PT2385 Tablets up to     the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.   "
75776|NCT02293967|"     The purpose of this study is to investigate the absorption, metabolism and excretion of     MT-1303 in healthy subjects.   "
75777|NCT02293954|"     This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal     antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive     cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may     help find and diagnose CEA positive cancer that may not be detected by standard diagnostic     methods.   "
75778|NCT02293941|"     The primary objective of this study is to assess changes in alanine aminotransferase (ALT) in     hepatitis C virus (HCV)-infected subjects given daily doses of JKB-122 for 3 months who have     been nonresponsive to, intolerable to, or relapsed from prior interferon-based therapies     (pegylated or standard) either alone or in combination with ribavirin or other anti-HCV     therapies including direct-acting anti-viral agents.   "
75779|NCT02293928|"     The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump     coronary artery bypass grafting. The impact of hybrid coronary revascularization using     minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel     remains unclear.      The aim of the study is to describe the impact of hybrid coronary revascularization on the     effect of aspirin and clopidogrel. Furthermore, we will investigate whether high baseline     platelet aggregation, high postoperative levels of platelet turnover and acute-phase response     may contribute to the effect.   "
75780|NCT02293915|"     The primary purpose of this study is to determine the efficacy and safety of Sodium     Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease.   "
75781|NCT02293902|"     Primary Objective:      To demonstrate that sarilumab added to MTX reduce signs and symptoms of rheumatoid arthritis     (RA) in Japanese RA patients with an inadequate response to MTX.      Secondary Objective:      To assess the safety of sarilumab added to MTX in Japanese RA patients with an inadequate     response to MTX.   "
75782|NCT02293889|"     Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of     increasing age and body fat. As there are no very effective therapies for KOA, disease often     progresses until knee replacement surgery is needed. It has been observed Vitamin D and     Physical Activity (PA) levels are lower in those with KOA, increased age and body fat. As the     relationship between KOA, Vitamin D and PA levels are not clearly understood, this study aims     to explore these relationships and the acceptability/feasibility of PA and Vitamin D     interventions in those who would likely to benefit from these interventions.      200-300 people, 50-70 years, BMI 30-40kg/m2, meeting American College of Rheumatology (ACR)     KOA Guidelines, will be recruited from North Tyneside and Liverpool Hospital trusts November     2014-January 2016 to participate in a single cross-sectional study visit, which will measure:     Vitamin D/Calcium serum levels, BMI/Body Fat, mobility, Quality of life and pain (by     questionnaire), and PA levels.      Those participants with insufficient Vitamin D levels (25-50nmol/L) and PA levels (<30min     moderate PA/week), will be invited to take part in a 3 month pilot RCT study.      >64 people will be recruited for the pilot RCT and equally randomly allocated to 1 of 4     intervention groups: Vitamin D (1 capsule a day: 2000IU), Placebo (identical capsule: 1 a     day), PA (online PA programme) and PA and Vitamin D. Additionally at the end of the 12 week     study visit, up to 20 participants will be invited to take part in a qualitative interview     exploring their experience during the two studies.   "
75783|NCT02293876|"     The purpose of the study is find out the better measure to achieve corneal protection in an     Intensive Care Unit.   "
75784|NCT02293863|"     This is a randomized, double-blind, placebo-controlled study that will investigate the safety     and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants     hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm     of placebo with oseltamivir.   "
75798|NCT02293681|"     The purpose of this observational (a study that follows participants forward in time) study     is to compare the functional improvement of hip joint using Harris hip score between 2     treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis     (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment     points) participants with hip involvement.   "
75785|NCT02293850|"     This is an open labeled, multiple centers, two countries (Taiwan and Korea) non-comparative     phase I/II trial in patients with hepatocellular carcinoma. In phase I part, a maximum of 33     patients will be recruited in this study. By utilizing a Simon optimal two-stage design, up     to 69 patients will be enrolled into this study, while considering the 20% drop-out rate, in     order to target 19 response-evaluable patients for the first stage and additional 36     response-evaluable patients for the second stage in phase II part study.   "
75787|NCT02293824|"     Almost all infants born <29 weeks gestational age develop apnea of prematurity and are     treated with caffeine. Type of diet and disease states may be significant contributors of     variability in caffeine metabolism and pharmacokinetics (PK) in this population. This     prospective, observational, open-label, opportunistic PK study will compare the population PK     of caffeine between infants fed formula and infants fed exclusively breast milk; compare the     activities of caffeine metabolizing enzymes between infants fed formula and infants fed     exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on     caffeine PK and metabolism in premature infants.   "
75788|NCT02293811|"     The inflammatory tumor micro-environment is a consequence and a driver of tumorogenesis. On     one hand it promotes antitumor immune responses and on the other hand it favors development     and progression of cancerous lesions.      Factors regulating the complex interplay between epithelial and immune cells are still poorly     characterized. Extracellular ATP (eATP) acting on the purinergic P2X7 receptors (P2RX7) has     recently emerged as a key signaling pathway in the immune response.      Recent data have revealed the crucial role of P2RX7-NLRP3-Caspase-1 for priming dendritic     cells (DC) within the tumor microenvironment upon treatment with certain types of     chemotherapy drugs. Despite this important discovery, no previous study has so far     investigated the global in vivo effect of P2RX7 modulation in inflammation-induced     carcinogenesis of mucosal tissues.      Our consortium, endowed by a long standing experience in the field of mucosal immunology,     inflammation and signaling, already demonstrated that the P2RX7 is differentially expressed     in the mucosa of patients with active and quiescent inflammatory bowel disease (IBD), where     eATP is present at very high concentration, and that P2RX7 controls an amplification loop of     the inflammatory response (Cesaro et al., 2010). Furthermore, we uncovered that P2RX7     controls homeostasis, survival and function of regulatory T cells (Hubert et al., 2010). In     addition, our recent demonstration that P2RX7 deficiency lowered mucosal inflammation but     unexpectedly enhanced tumor formation in vivo warrants additional efforts to explore the     molecular and cellular mechanisms accounting for this effect and suggest that enhancing P2RX7     function may have an anti-tumor therapeutic effect.      These observations emphasize the tumor suppressor role of P2X7 receptor, warrant further     investigation to better understand the molecular mechanisms responsible for this anti-tumor     effect and suggest that enhancing the function of P2X7R could have a therapeutic effect     significant antitumor.      Our main objectives is to explore the role of P2RX7 in healthy, inflammatory and cancerous     colonic mucosa. For this we will map the expression of the protein P2RX7 and realize genotype     of P2RX7 forms in inflammatory diseases and cancer of the colon.   "
75789|NCT02293798|"     The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold     to maintain the size of the areola by providing additional soft tissue support after     circumferential periareolar mastopexy.   "
75790|NCT02293785|"     The symptoms associated in advanced cancer patients and adverse events due to use of opioids     have major influence on the state of health and quality of life of patients. The pain, in     particular, is a symptom with severe negative impact and with a prevalence ranging between     33% and 64%, according to the stage of the disease, with values around 70-90% in advanced     stages and metastatic.      The use of opioids, however, is usually associated with the appearance of common adverse     events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are     self-limiting in the time for the appearance of tolerance while others, as constipation     persist.      Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN),     which consists in the union between a molecule agonist and an antagonist of opioid receptors,     reduced the constipation in the presence of unchanged analgesic efficacy compared to     oxycodone alone.   "
75791|NCT02293772|"     A loss of body weight has been documented in lowland-living individuals when exposed to     hypoxic environments, such as at high altitude, or under laboratory conditions. A reduction     in appetite and energy intake has also been reported during conditions of microgravity, such     as during space flight. Fourteen normal or over-weight men, who are otherwise healthy, will     undergo 3x 21-day interventions; normobaric normoxic bed rest (NBR; FiO2=21%), normobaric     hypoxic ambulatory confinement (HAMB; FiO2=14%; ~4000 m simulated altitude), and normobaric     hypoxic bed rest (HBR; FiO2=14%). The effects of hypoxia and bedrest on appetite and its     hormonal control will be assessed before and at day 17 of each intervention using a mixed     meal tolerance test.   "
75792|NCT02293759|"     Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal     bleeding profile.      Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on     prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller     prostates will be treated with greenlight PVP   "
75793|NCT02293746|"     The purpose of this study is to obtain additional safety and efficacy data on the use of     Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep     Apnea.   "
75794|NCT02293733|"     The purpose of our retrospective study is to describe which circumstances EGFR TKI is     continued despite progression according to the usual Response Evaluation CrIteria in Solid     Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR     TKI .We will collect their social and demographic data (age, sex), first Progression Free     Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first     progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from     diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more     closely the mode of progression (site), the therapeutic approach at disease progression. We     will define two subgroups: those for whom EGFR TKI was continued at least three months     despite progression defined according to RECIST criteria, and those for whom a second-line     treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be     individualized the subgroup of patients in whom it was continued TKI after progression.   "
81209|NCT02222974|"     The objective of the study is to obtain information about safety, tolerability and     pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses     in healthy male volunteers   "
75797|NCT02293694|"     The feasibility of Sayana Press self-injection and the potential for this practice to     increase contraceptive continuation has never been assessed in family planning programs in     low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for     International Development (USAID) Malawi Mission requested the Advancing Partners and     Communities (APC) project to assess self-injection of Sayana Press to inform their     decision-making for procurement of Sayana Press and distribution through the health system in     Malawi.   "
75803|NCT02293616|"     It is well documented that intensive care unit (ICU) patients have lower levels of skeletal     muscle strength compared to non-ICU patients upon hospital discharge, and this weakness     affects the patient's ability to perform basic activities of daily living upon hospital     discharge and for extended periods thereafter. Recently, critically ill ICU patients have     been shown to have lower nitric oxide levels. These patients often suffer from a disturbed     homeostasis with circulatory and metabolic abnormalities that may potentially contribute to     their ICU acquired weakness. Given the recent research showing dietary nitrate     supplementation can increase nitric oxide levels and improve exercise tolerance in healthy     and diseased older individuals, our aim is to investigate the importance of nitrate     supplementation in ICU patients with focus on physical function and ICU acquired muscle     weakness.   "
75804|NCT02293603|"     To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary     infusion in subjects with DCM. The study will further explore safety and exploratory efficacy     endpoints of CAP-1002.   "
75805|NCT02293590|"     Tight control of an adaptive concomitant treatment strategy after initiation of CZP will lead     to an improved outcome of RA patients with an active disease despite DMARD treatment.   "
75806|NCT02293577|"     The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day to     day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM will     identify caloric and exercise related variation in blood glucose that is not identified by     the subjects' current regimen of intermittent finger stick blood glucose measurements.   "
75807|NCT02293564|"     The purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment     of active inflammatory, erosive osteoarthritis of the hand.   "
75808|NCT02293551|"     The purposes of this study are to determine:        -  Part A             -  How quickly your body absorbs, breaks down and gets rid of the different               formulations of insulin lispro compared to insulin lispro alone formulation.             -  The safety of insulin lispro in different formulations and any side effects that               might be associated with it.        -  Part B:             -  How much insulin lispro from different dose ranges is found in the bloodstream               using a test insulin lispro formulation (selected from Part A).             -  The safety of insulin lispro in different formulations and any side effects that               might be associated with it.      Participants may only enroll in one part. The study is expected to last up to 10 weeks for     each part.   "
75809|NCT02293538|"     The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after     2 hours of lens wear with use of FID 114657 compared to saline control.   "
75810|NCT02293525|"     The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion     catheter & wound drain in patients following lumbar spinal fusion surgery. One half of the     patients will receive continuous local analgesic fusion during the post-operative period     while the other half will received continuous local saline.   "
75811|NCT02293512|"     Tinnitus (i.e., ringing in the ears) is currently the most prevalent disability among     Veterans. A range of clinical interventions has been created to systematically address the     range of issues caused by tinnitus. While numerous interventions purport to promote coping     strategies for tinnitus-related problems, few studies directly target and measure coping     outcomes. The present pilot study proposes a comparison of coping outcomes after 3     psycho-educational groups: a cognitive-behavioral therapy (CBT) intervention, a Coping     Effectiveness Training (CET) intervention, or an Acceptance and Commitment Therapy     intervention among Veterans with tinnitus. These groups will be compared to a usual care     group among Veterans and civilians with tinnitus. The proposed study will be the first     application of CET to tinnitus. The primary goals of this study are to develop a CET protocol     for tinnitus and to evaluate the effectiveness of CBT, CET, and ACT interventions to a usual     care group. The long-term goal of this study is to improve the quality of life among     individuals with tinnitus.   "
75812|NCT02293499|"     Asthma is a serious chronic health condition particularly in inner-city adolescents, who     suffer disproportionately high asthma-related morbidity and mortality that place heavy     economic burdens on families and society. There is a consensus that adverse asthma outcomes     can be ameliorated by an individual's active engagement in adequate self-management. This     multi-site randomized controlled study proposes to implement and evaluate a peer-led asthma     self-management for adolescents (PLASMA) program that has demonstrated its feasibility and     preliminary efficacy in a previous study. PLASMA will be implemented in three cities (Buffalo     NY, Baltimore MD, and Memphis TN) that have particularly high rates of pediatric asthma and     asthma-related morbidity, and are thus most likely to benefit from the program. PLASMA     comprises three main components: (a) peer-leader training; (b) a one-day asthma camp where     peer leaders will deliver manualized self-management content recommended by the national     guidelines; and (c) bi-monthly peer-leader contacts. Specific aims are: (1) to evaluate the     effectiveness of PLASMA in inner-city adolescents with asthma in improving quality of life     (primary outcome), and asthma knowledge, attitudes, outcome expectations, self-efficacy,     self-management skills, and asthma control, FEV1 (exploratory outcomes) over time, compared     to a control group for whom adult leaders will deliver the same program content; (2) to     examine the mediating effects of the exploratory outcomes on quality of life; (3) to examine     the moderating effects of personal factors (e.g., age, sex, family support) on the     intervention's primary and exploratory outcomes; (4) to evaluate the effects of PLASMA on     study outcomes in peer leaders (16-20 years); and (5) to determine the economic impact of the     intervention. These aims will be accomplished using a two-group randomized controlled trial     with 378 adolescents (12-17 years) from the three cities (126 for each site). A total of 42     qualified peer leaders (14 in each site) will be enrolled based on adult nomination.     Eligibility criteria for both peer leaders and adolescent learners include: a current asthma     diagnosis; persistent asthma; absence of other chronic or mental illness; inner-city     residence; and capability of verbal and written communication in English. Participants will     provide data at enrollment (T1), camp (T2), and at 3-, 6-, 9-, 12-, and 15-months post-camp     (T3-T7). Data will be analyzed using a multi-site hierarchical three-level linear     mixed-effects model where level 1 represents repeated measures, level 2 = subject, and level     3 = site. To determine the economic impact of the program, investigator will measure the     direct healthcare costs and total costs of the program, and perform net cost analyses for     each type of costs. In addition, investigator will estimate cost-effectiveness ratios of the     PLASMA group compared with the control.   "
75813|NCT02293486|"     The purpose of this study is to evaluate modifications of plasma protein carbonyls and     malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice     consumption.   "
75814|NCT02293473|"     This study is designed to test if measuring the depth of anaesthesia, brain tissue     oxygenation and haemodynamic parameters and specially designed interventions according to the     measurements can improve the outcome of high risk surgical patients undergoing major     abdominal surgery.   "
75815|NCT02293460|"     Primary objective:      To assess the efficacy of I10E in improving the disability of patients with CIDP.      Secondary objective:      To assess the safety of I10E in patients with CIDP.   "
85870|NCT02162030|"     The purpose of this study is to determine whether a specific component of Acceptance and     Commitment Therapy (ACT) called 'Self as Context' is an important and necessary part of this     therapeutic approach.   "
75816|NCT02293447|"     Uterine artery embolization (UAE) is a minimally invasive treatment for women with     symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms     improvement, with fewer complications and at lower cost. However, the majority of women     undergoing UFE experience important pain after the procedure despite optimal analgesia, with     one third reporting pain equal or worse than labor. Pain is the more common cause of     prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce     post-procedural pain.      For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine,     injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3     groups: control, lidocaine injected during embolization, and lidocaine injected after     embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention.     Hospital length-of-stay and total narcotic dose administered will be evaluated in the three     groups.      This is the first Canadian study evaluating lidocaine use for pain control in UFE patients.     Results will be transferable to clinical practice, considering the use of lidocaine is simple     and cost is negligible. It could have a great impact on pain management in women undergoing     UFE in all practice settings.   "
75817|NCT02293434|"     Study rationale: Children admitted to intensive care are often chronically ill and the     intensive care setting may upset the balance between nutritional intakes and needs.      As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units     (PICUs), screening for malnutrition and the individualized adaptation of nutritional support     are important elements of patient care. Yet no recent study has evaluated the nutritional     status of children admitted to PICUs in France.      Primary Objective: Determine the prevalence of malnutrition in the population of children     admitted to intensive care.      Secondary objectives:        -  Determine the children's nutritional status on admission.        -  Characterize the profile of malnourished patients compared with those not malnourished          (sex, age, history, chronic disease, usual dietary habits, reason for admission,          scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).        -  Describe the practices regarding nutritional care in each center.      Population: All children (1 month to 18 years) admitted to all PICUs in France during three     one-week periods (February, June, October) in the course of a year.   "
75818|NCT02293421|"     Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA     is associated with a large number of co-morbidities, and thus, it is of great importance to     identify the patients and start treatment in order to reduce the risks for complications.     Current screening tools are quite unspecific and the golden standard methodology for     diagnosis, polysomnography, is expensive and time consuming, thus not suitable for screening.     In perioperative medicine the STOP BANG screening questionnaire is currently the recomended     screening tool, however this questionnaire has only been evaluated in a sleep clinic in a     very limited numbers of patients.   "
75819|NCT02293408|"     The objectives of this study are to describe the clinical and biochemical characteristics and     course of disease progression in patients with MPS IIIB   "
75820|NCT02293395|"     The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with     acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine     diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in     participants with a recent acute coronary syndrome (ACS: including ST segment elevation     myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome     [NSTE-ACS]).   "
75821|NCT02293382|"     The objective is to perform a retrospective chart review to generate data to evaluate the     clinical characteristics and course of disease progression of MPS IIIB.   "
75885|NCT02292550|"     This is a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6     inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.      The purpose of the study is to determine the MTD/RP2D of the LEE011 and ceritinib combination     and evaluate whether the combination is safe and has beneficial effects in ALK-positive     advanced non-small cell lung cancer patients.   "
75822|NCT02293369|"     American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive     methods in gynecological surgery to ensure increased benefits to the patient and reduce     potential hospitalization costs.      Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders.     During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures,     techniques and approaches, which is one of the challenges of this surgery. Data is limited on     potential impact of different sutures, techniques and approaches for vaginal cuff closure on     female sexual function in relation to vaginal length.      Various studies in the literature evaluated different approaches (abdominal, vaginal,     laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different     techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures     like operation time, cuff healing, complications, cost effectiveness, etc. were usually     measured. However, there is no prospective randomized clinical study in the literature that     compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual     function in relation to vaginal length.   "
75823|NCT02293356|"     This clinical study is designed as an open, single group, multi-center, phase 4 clinical     study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to     provide a more reasonable basis for clinical drug programs.   "
75824|NCT02293343|"     Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine     profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum     and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine     in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and     IgE Antibodies were measured.   "
75825|NCT02293330|"     This study is developed to determine if the local anaesthetic dose can be reduced by the use     of intermittent bolus technique compared to continuous infusion when the nerve catheter is     placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Our primary     outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve     catheter. Our hypothesis is that with an intermittent bolus less local anaesthetic is     necessary the first postoperative 48 hours after surgery for adequate postoperative     analgesia. As secondary outcomes the investigators study pain scores, motor block, sensory     block, feeling of numbness, patient satisfaction, sleep quality and rescue analgesia during     the nerve block and afterwards.   "
75827|NCT02293304|"     The aim of this study is to evaluate the 18-month clinical performance of a multimode     adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after     partial carious removal. This randomized clinical trial will include subjects (5-10 year-old     children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132     primary molars presenting active cavitated carious lesions (with radiographic involvement of     the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The     sample will be randomly divided into two groups according to bonding approach: etch-and-rinse     or self-etch strategy. The restorations will be clinically followed every 6 months for up to     18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for     restoration longevity will be evaluated using the Kaplan-Meier method.   "
75828|NCT02293291|"     Although thermal therapy has been utilized in the rehabilitation of war veterans since the     Roman Empire, no investigations actually exist about the use of thermal therapy in GWI, This     due to the fact that nobody knows that the cure for the syndrome in GWI veterans may exist in     thermal therapy which is the primary objective of this investigation.   "
75829|NCT02293278|"     The purpose of this pilot study is to test the efficacy of the physical activity (PA)     intervention protocol to increase preschoolers overall PA levels and time spent in moderate     to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy     Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement     based activities developed for preschoolers and successfully piloted for feasibility in 3 to     5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As     well, the PA intervention includes educational workshops for the day care providers, ongoing     biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment     necessary to implement the program. The study is also evaluating the efficacy of the PA     intervention to decrease the amount of time spent in sedentary behaviour at the day care     setting.      Secondary objectives include evaluating the effects of the PA intervention on preschool     children's anthropometrics, and fundamental and gross motor skills. In addition, the     intervention is also assessing the effects of the program on day care provider's attitudes,     control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.   "
75830|NCT02293265|"     This will be a non-drug interventional cross-sectional study, where the screening visit and     study visit can occur on the same day. Investigational product will not be administered.     Approximately 790 subjects with severe asthma will be screened to achieve a total of at least     750 evaluable study subjects. The study will not include a run-in or follow-up period. This     study will provide a more reliable description of the severe asthma patient landscape with     respect to the potential eligibility for treatment with mepolizumab, omalizumab, and     reslizumab. This study aims to estimate the potential overlap of patients eligible for     treatment with mepolizumab and those eligible for treatment with omalizumab and/or     reslizumab. Additionally, the current study will also ascertain and describe reslizumab     eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient     population.   "
75831|NCT02293252|"     The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the     combined clinical endpoint days alive and not in hospital nor stationary care per days in     study and the change in total cost compared to that of the control group.   "
75832|NCT02293239|"     This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS)     training combined with individualized nutritional support on body composition, muscle     strength and function and quality of life of patients with malignant disease undergoing     curative or palliative anti-cancer treatment   "
75834|NCT02293213|"     Investigators propose a randomized controlled trial of women taking category D or X     medications seen in family medicine, internal medicine or in the Coumadin Clinic. Women in     the intervention group will receive an electronic medical record referral for teratogen     counseling and contraceptive counseling with a follow up contraceptive provision appointment.     The contraceptive counseling will be adapted from The Contraceptive CHOICE Project script and     promote the use of the long acting reversible contraception. The women in the control group     will also receive an electronic medical record referral and receive the teratogen counseling     but only be told that it is important to avoid becoming pregnant. An initial survey will     assess contraceptive knowledge and utilization. In addition, there will be telephone survey     at 3 months and 6 months to assess contraceptive utilization and continuation.   "
75835|NCT02293200|"     The aim of the study was to compare two methods of training in CPR, standard basic life     support and CPR using CPR feedback device.   "
75836|NCT02293187|"     This one-year study will test the hypothesis that supplementation with vitamin D will improve     lower extremity muscle performance in older men and women with vitamin D insufficiency.   "
75837|NCT02293174|"     Establish a normal baseline setting configuration for image capture using the Topcon     TRC-NW400 non-mydriatic retinal camera.   "
75838|NCT02293161|"     GSK2618960 is a humanized Immunoglobulin G 1 ( IgG1) monoclonal antibody (mAb) that binds to     the alpha component (CD127) of the heterodimeric Interleukin-7 receptor (IL-7R). It is being     developed for the treatment of autoimmune indications. This study is intended to further     explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and     immunogenicity of single ascending doses GSK2618960 in healthy volunteers beyond those     already evaluated in I7R116702 (First Time In Human study). The study is anticipated to enrol     18 subjects in total, with 9 subjects in each of the two cohorts.   "
75839|NCT02293148|"     This study is being performed to comply with regulatory requirements that all new     non-antiarrhythmic drugs must be assessed for potential effects on cardiac repolarization     through electrocardiographic evaluation in a 'Thorough QT/ Corrected QT interval (TQT)'     study. This will be a two part study, Part A will be an open-label, single oral dose study     design in order to evaluate the pharmacokinetics, safety and tolerability of a 500 milligram     (mg) dose of GSK1278863 and Part B will be a single-blind, randomized, placebo-controlled,     single, oral dose, four-way crossover study design. Parts A and B will be conducted in     healthy adult subjects with 12-lead electrocardiograms (ECGs), clinical laboratory safety     tests, vital sign measurements, physical examinations, adverse event reports, and     pharmacokinetic samples collected throughout the study.   "
75840|NCT02293135|"     The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic     patients referred on the diabetic consultations. The effects of one Stendo pulsating suit     session system will be assessed on the peripheral cutaneous microcirculation and on     endothelial functions   "
75841|NCT02293122|"     The purpose of this study is to evaluate the precision and agreement of the study device, a     specular microscope, in comparison to a currently commercially available specular microscope     in establishing substantial equivalence of the two devices in clinical use for diagnostic     purposes of the human cornea.   "
75842|NCT02293109|"     This phase I trial studies the side effects and best dose of carfilzomib when given together     with the hyperfractionated (hyper)-cyclophosphamide, vincristine sulfate, doxorubicin     hydrochloride, and dexamethasone (CVAD) chemotherapy regimen in treating patients with newly     diagnosed acute lymphoblastic leukemia or lymphoma. Carfilzomib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone,     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with     combination chemotherapy may kill more cancer cells.   "
75843|NCT02293096|"     The investigators will prospectively follow a population of patients with uncontrolled high     blood pressure beginning metoprolol succinate therapy to determine the drug effect in an     observational clinical trial. The investigators will determine each individual's genotype for     both CYP2D6 and Adrenoceptor Beta 1 (ADRB1). Metabolomic markers will be identified to     determine if specific metabolites are associated with drug response. The investigators'     overall objective is to determine if genetics predicts metoprolol succinate response better     than clinical factors such as age, race, body mass index, dose, and medication co-ingestion.   "
75844|NCT02293083|"     Myofascial pain syndrome (MPS) is the most common cause of persistent regional pain     characterized by myofascial trigger points. Trigger point injection (TPI) using local     anesthetics is one of the most effective methods for treatment of MPS, and steroids or     botulinum toxin can be added to local injections .      Recent study suggested that the hyaluronan (HA) could be the basis of myofascial pain. HA     within the deep fascia facilitates the free sliding of two adjacent fibrous fascial layers.     If the HA assumes a more packed conformation, or more generally, if the loose connective     tissue inside the fascia alters its density, the behavior of the entire deep fascia and the     underlying muscle would be compromised.      The investigators anticipated that hyaluronidase could decrease the viscosity of HA near the     muscle and fascia of trigger points. Meanwhile, hyaluronidase is thought to promote the     spread of local anesthetic solution by hydrolyzing glycosidic bonds within HA. Hyaluronidase     was shown to be effective in retro- and peribulbar block for ophthalmologic surgery or     reducing tissue edema in dermatology, and adhesiolysis for some interventional pain     managements.      However, the effect of the addition of hyaluronidase to local anesthetics during TPI has not     been studied. The investigators aimed to compare the efficacy of TPI with the addition of     hyaluronidase compared to local anesthetic alone on pain and quality of life in MPS patients.   "
75845|NCT02293070|"     The objective of this study is to utilize delayed enhanced cardiac magnetic resonance imaging     to assess the success of pulmonary vein isolation after cryoablation of paroxysmal atrial     fibrillation. The primary hypothesis is that cardiac magnetic resonance imaging will be able     to visualize changes in left atrial tissue characteristics caused by cryoablation used to     treat paroxysmal atrial fibrillation.   "
75913|NCT02292186|"     The purpose of this study was to evaluate the safety and clinical activity of long-term     dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being     followed-up for safety.   "
75846|NCT02293057|"     Girls in the juvenile justice system have unique developmental pathways to drug use and     co-occurring risk (e.g., HIV/STI) behaviors that have typically not been considered or tested     in order to identify evidence-based gender-specific substance use treatment approaches for     this population. This study will advance scientific knowledge and clinical practice in the     drug treatment and public health fields by testing the efficacy of a pre-existing, widely     disseminated gender-responsive substance use treatment (VOICES) on drug use and HIV/STI risk     behavior outcomes for a broad range of substance using girls and young women (ages 12-24) who     are at-risk for or already involved with the justice system.   "
75847|NCT02293044|"     This study will compare the safety and effectiveness of a potassium oxalate desensitizer on     adjacent teeth with dentinal hypersensitivity.   "
75848|NCT02293031|"     The purpose of this study is to evaluate safety and efficacy of gene-activated matrix     (Nucleostim) for regeneration of bone tissue in maxillofacial area. Patients with     congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after     injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone     atrophy will be included into the study.   "
75849|NCT02293018|"     The purpose of this study is to determine the pharmacokinetic properties of topically applied     MTC896 Gel following application of 0.75% (w/w) MTC896 Gel once daily and twice daily and     1.5% (w/w) once daily over 4 weeks in the treatment of acne.   "
75850|NCT02293005|"     Objectives:      Objectives      The primary objective of this study is to:      To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable     malignant pleural mesothelioma (MPM) treated with alisertib      The secondary objectives of this study are to:      To assess the response rate (confirmed and unconfirmed complete + partial responses) To     assess the progression-free survival. To assess overall survival. To evaluate the side     effects and toxicities associated with this treatment regimen.      To collect archival tissue, blood, pleural effusion fluid and plasma for correlative studies.      Exploratory Objectives:      To collect archival or new tissue, blood and pleural effusion fluid for correlative studies.     Tissue biomarkers to be evaluated include aurora kinase pathway and c-myc gene amplification.      Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.   "
75851|NCT02292992|"     The difference of lung volume change will be monitored by electrical impedance tomography     before and after use of noninvasive positive pressure ventilation by nasal pillow and high     flow nasal cannula in post-extubation patients.   "
75852|NCT02292979|"     This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination     (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with     an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography )     after two cycles of chemotherapy.   "
75853|NCT02292966|"     The purpose of this study is to examine whether neurocognitive impairments experienced by     patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with     a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and     beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous system     (CNS) by assessing neurocognitive function and brain injury prior to treatment, and comparing     it to the end of treatment, and 4, 12 and 24 weeks after treatment.   "
75854|NCT02292953|"     The purpose of the study is to determine whether or not stressful conditions such as ovum     pick and awaiting Embryo Transfer is associated with significant increase in serum Prolactin     (PRL) concentration in some normo-prolactinemic patients undergoing intracytoplasmatic sperm     injection (ICSI) & possible effect on implantation & pregnancy rate.   "
75855|NCT02292940|"     Patient use of health IT tools to interact with healthcare providers and delivery systems,     including exchanging secure messages with their medical providers and using other web-based     tools, has great potential to increase patient access to care, change the way healthcare is     delivered, and affect patient clinical outcomes. This study will examine the impact of     implementation and use of consumer health IT tools on patient-reported access to care,     utilization of medical care services, and clinical outcomes.   "
75856|NCT02292927|"     DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the     acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation     program in a cohort of patients undergoing aneurysm repair.      This will enable the design (feasibility and power) of a large scale Randomised Controlled     Trial.      Expected outcomes        -  The potential number of patients who would benefit, the compliance and acceptability of          a pre-operative prehabilitation programme will be calculated.        -  Preoperatively, expected at 6-weeks, the change in physical fitness of patients          (assessed by the physical function section of SF-36 and measured with peak flow/6-minute          walk testing) during the pre-operative phase will be assessed in both groups.        -  The effects on quality of life, anxiety and depression on each study participant will be          assessed immediately pre-op, expected at 6-weeks.        -  The number of patients who are able to reduce or cease smoking will be reported during          the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic          surgery, expected at 6-8 weeks.      POPULATION: Patients undergoing planned elective aortic surgery procedures      ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular     aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative     exercise programme DURATION: 1 year from 1st June 2014   "
75868|NCT02292771|"     The primary objective of this study is to demonstrate the superiority of retosiban to prolong     pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is     based on the hypothesis that prolonging the time to delivery in the absence of harm may     benefit the newborn, particularly in women who experience spontaneous preterm labor at early     gestational ages (GA). This study is designed to test this hypothesis through a direct     comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term     use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks' gestation in     preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6     phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery,     Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females     will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of     any one subject's (maternal or neonatal) participation in the study will be variable and     dependent on GA at study entry and the date of delivery.   "
75857|NCT02292914|"     The robot-assisted surgery allows three-dimensional view, detailed access of small     structures, depth perception and articulated movements with wide latitude. Thinking about the     inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors     and other health professionals , and has three tutors in the area of robot- assisted     laparoscopic surgery , and various medical clinical staff , already trained , and already     perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in     the World market) , consisting of one or two consoles for the surgeon and a tutor if     necessary was adopted. Ergonomically designed, a stand next to the patient , with four     interactive robotic arms , one of them , a vision system for high performance and the other     three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology ,     computer programs , frictionless transmission of manual controls , movements in scale and     filtered made by the surgeon in the da Vinci ® System console are translated into precise     movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers superior     3D viewing with larger surgical precision ergonomic comfort and dexterity . For hospitals ,     the da Vinci ® Surgical System enables clinical and economic benefits of minimally invasive     surgery are applied to a broader base of patients cirúrgicos.The main objective is to     evaluate the safety and effectiveness of robotic surgery in the surgical treatment of cancer     in operations below, as their specialties : Digestive , Urology , Gynecology , Head and Neck     and Thorax . This is a prospective study lasting 36 months , where 1120 patients with     surgical diseases in programming for the following operations will be studied : transthoracic     esophagectomy ; subtotal gastrectomy with lymphadenectomy ; partial pancreatectomy ;     resection of the rectum ; prostatectomy ; cystectomy ; partial nephrectomy ; hysterectomy     with or without pelvic and paraaortic lymphadenectomy ; resection of malignant tumors of the     mouth and orofaringolaringe and lung lobectomy . Patients will come from the outpatient     services of the Institute of Cancer of São Paulo - ICESP   "
75858|NCT02292901|"     Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac     videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of     difficult of mask ventilation and of tracheal intubation.   "
75859|NCT02292888|"     Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to     calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the     product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ).      The LVOT diameter for an individual is more or less a constant measurement. Therefore using     the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then     SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to     achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this     assumption is true, then an increase in the value of VTI from baseline after fluid challenge     (10-15%), should identify a volume responsive patient.   "
75904|NCT02292303|"     The main objective of this clinical is to get information on pharmacokinetics of     zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to     two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.   "
75860|NCT02292875|"     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising     vaccine, currently being developed for the treatment of grass allergy.      The purpose of this optional observational follow-on study is to further evaluate     rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all     dosing visits in study TG002 approximately two years after the start of treatment.   "
75861|NCT02292862|"     Maternal microchimerism has been discussed as an etiological mechanism in infantile     (perinatal) biliary atresia (BA). In Kasai's operation (resection of the liver hilum plaque     followed by hepato-portoenterostomy) surgeons frequently encounter swollen portal and     mesenteric lymph nodes.      Lymph nodes were sampled during Kasai' s operation and examined for maternal DNA.   "
75862|NCT02292849|"     The goal of this study is to test the feasibility, acceptability and preliminary impact of     peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally     Occurring Retirement Communities (NORC) residents or senior center participants.   "
75863|NCT02292836|"     The purpose of this study is to test and refine, a subject questionnaire aimed to be used in     a general population rosacea prevalence study.   "
75864|NCT02292823|"     Prospective, non-randomized, single arm, multicenter observational study. The objective is to     evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo     stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary     intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world     setting.   "
75865|NCT02292810|"     Type 2 diabetes is associated with respiratory muscle weakness and autonomic neuropathy. The     exercise of inspiratory muscles has been investigating in various clinical situations and may     cause similar benefits as the conventional exercises. The assessment of glucose variability     has been used as an alternative tool to evaluate the others mechanisms than the absolute     values of glucose levels, special during the exercise. However, the effect of inspiratory     muscle exercise on glucose levels and glucose variability is not clear yet. The aim of the     proposed research is to evaluate the acute effects of inspiratory muscle exercise using a     high load of 60% of MIP on glucose levels and glucose variability in patients with type 2     diabetes.   "
75866|NCT02292797|"     Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea     Prevalence in the General Population.   "
75867|NCT02292784|"     The primary objective of this study is to assess the safety and outcomes of infants and     children who were exposed to retosiban or comparator in utero in the planned Phase III     spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is     not associated with significant adverse outcomes in early childhood. The enrolled infants and     children will be followed at pre-specified intervals until they reach 5 years chronological     age. This study does not require medical interventions or study visits to an investigational     site, instead, parents or legal guardians will be prompted at certain time points to complete     developmental questionnaires and other data on their children's health status via an     electronic device. Data collected during the infant and child follow up study will be managed     by a centralized research coordinating center (RCC). Regionally based pediatricians will     serve as study principal investigators (referred to as RCC-PIs) for this study. All     communications the RCC-PI has with the parent/legal guardian or the child's health care     provider (HCP) will occur remotely; there will be no clinic visits.   "
75869|NCT02292758|"     This randomized phase II trial studies how well irinotecan and cetuximab with or without     bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to     other places in the body and cannot be removed by surgery. Irinotecan may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,     such as cetuximab and bevacizumab, may interfere with the ability of tumor cells to grow and     spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in     treating patients with colorectal cancer.   "
75871|NCT02292732|"     This is a Phase I, open-label, non-randomized, sequential, two-period, repeat-dose study to     evaluate the effect of trametinib 2 milligram (mg) once daily on the repeat-dose     pharmacokinetic (PK) of an oral contraceptive (OC) containing norethindrone (NE) and ethinyl     estradiol (EE) (ORTHO-NOVUM® tablets: 1 mg NE + 0.035 mg EE) in female subjects with solid     tumors.      The study will determine PK interaction between trametinib and the components of combination     oral contraceptives that would compromise the effectiveness of the contraceptives.      The study will also evaluate the repeat dose PK of trametinib and its metabolite M5 using a     validated assay.      The study will enroll approximately 24 subjects. Each subject will participate in the study     for approximately up to 13 to 15 weeks which will consist of a 30 day screening period,     followed by 2 treatment periods (Period 1: 28 days and Period 2: ranging from 12 days to up     to 21 days), and a transition visit or post-treatment follow-up visit. In Period 1, subjects     will take one active tablet from the ORTHO-NOVUM® tablet 1/35 dial-pack once daily at     approximately the same time each day for 21 days (Days 1 through 21), followed by one inert     (referred to as placebo) tablet once daily at approximately the same time each day for 7 days     (Days 22 through 28). In addition, subjects will take trametinib 2 mg (1 tablet) once daily     at approximately the same time each day for a total of 17 days (Days 12 through 28). In     Period 2, subjects will take one active tablet from the ORTHO-NOVUM® tablet 1/35 dial-pack     once daily at approximately the same time each day for 11 days (Days 1 through 11). In     addition, subjects will continue taking trametinib 2 mg (1 tablet) once daily at     approximately the same time each day for 11 days (Days 1 through 11). ORTHO-NOVUM® is a     registered trademark of Ortho Pharmaceutical Corporation.   "
75872|NCT02292719|"     The purpose of this study is to evaluate the safety and efficacy of ombitasvir/ABT-450/r with     sofosbuvir with or without ribavirin in adults with Genotype 2 Chronic Hepatitis C Virus     (HCV)infection or Genotype 3 HCV infection With or Without Cirrhosis.   "
75873|NCT02292706|"     This Registry will enroll cirrhotic participants with or without decompensated liver disease     who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir     (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored     hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants     will be followed for up to 5 years.   "
75874|NCT02292693|"     The aim of this study was to compare time, success rates of different laryngoscope blades for     intubation with an immobilized cervical spine in a standardized pediatric manikin model.   "
75875|NCT02292680|"     This study aims to identify early life exposures to metals and chemicals by measuring the     concentration of metals and organic compounds in shed primary teeth. The researchers will     also investigate associations between the presence of these chemicals in teeth and children's     social, emotional, and neuro-development.   "
75876|NCT02292667|"     The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus     abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the     postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP     study is a single-center open-label randomized controlled trial. Half of patients included     will receive the association of TAP block and multimodal intravenous analgesia, and the other     half will receive the multimodal intravenous analgesia alone. The multimodal intravenous     analgesia includes intravenous paracetamol and intravenous patient-controlled analgesia with     morphine.   "
75877|NCT02292654|"     Primary Objective:      To evaluate the safety and tolerability of olipudase alfa administered intravenously in     pediatric patients every 2 weeks for 52 weeks.      Secondary Objective:      To characterize the pharmacokinetic profile and evaluate the pharmacodynamics and exploratory     efficacy of olipudase alfa administered intravenously in pediatric patients every 2 weeks for     52 weeks.   "
75878|NCT02292641|"     In the UK approximately 28,000 patients per year are diagnosed with bowel cancer. Further     15-20% develop pelvic recurrence. In a significant proportion of patients (15-20%), tumour     extends beyond what the surgeon can routinely remove and requires more extensive     (exenterative) surgery to achieve successful removal of the tumour. Currently MRI is used for     the assessment of the pelvic tumour and PET/CT is used in order to prove that there is no     extrapelvic disease, for the selection of patients who will undergo such a complex surgery.     The investigators have previously shown, with a single centre retrospective analysis, that     using a specific staging system for these tumours it is possible to predict both the     likelihood of surgical success and overall survival outcomes. Until today there are no     national guidelines for this group of patients.      The investigators want to test whether standardizing the assessment of these advanced tumours     will help to improve outcomes for patients and better surgical planning. The investigators     also want to show that the information from the scans gives valuable data regarding the long     term outcomes and likelihood of surgical success.      This is a multicentre prospective trial of patients, who require more extensive surgery,     using the staging classification. The high resolution MRI scans that patients undergo before     surgery will be reported using the previously validated system.      It is hoped that the study will result in a better and standarised method of assessing     advanced pelvic cancer, with the intent to improve the surgical planning and overall patient     management, which may increase the possibility of surgical curative resection.   "
75879|NCT02292628|"     This is a clinical trial phase I/II, double blind, randomized to compare in two groups of     patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from     the adipose tissue (CMMAd) in the treatment of the faecal incontinence.   "
75880|NCT02292615|"     In this prospective cohort study, patients with newly diagnosed gynecologic cancers     (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent     gynecologic cancers will be enrolled. The study period is two years and the estimated patient     number is about 220. Patients will undergo image study before and after treatment. The     diagnostic accuracy of MR-PET in cancer staging and the potential image biomarkers to monitor     treatment response and predict treatment outcome will be investigated.   "
75881|NCT02292602|"     The purpose of this study is to examine the feasibility, acceptability, and preliminary     efficacy of a community and home-based preschool obesity intervention for families enrolled     in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).   "
75882|NCT02292589|"     The purpose of this study is to determine the early effects of transcranial direct current     stimulation (tDCS) in patients with mild traumatic brain injury and persistent post     concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive     function(inhibitory control).   "
75883|NCT02292576|"     Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols     cocoa   "
75884|NCT02292563|"     The purpose of this study is to determine whether experienced endoscopy nurse participation     during screening colonoscopy could increase polyp and adenoma detection rate.   "
75914|NCT02292173|"     The main purpose of this study is to see whether the combination of trametinib and sorafenib     can help people with hepatocellular cancer. Researchers also want to find out if the     combination of trametinib and sorafenib is safe and tolerable.   "
75886|NCT02292537|"     The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS     396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy     (SMA). The secondary objective is to examine the safety and tolerability of nusinersen     administered intrathecally to participants with later-onset SMA.   "
75887|NCT02292524|"     Prostate Biomarkers in Men Consuming Tomato Products   "
75888|NCT02292511|"     The purpose of this study is to determine if a 6 month mind-motor intervention will help to     improve overall brain health in adults over the age of 55 with type 2 diabetes and a     self-reported complaint about memory or thinking skills. It is hypothesized that the     intervention group will show improvements in their overall brain health after 6 months of     mind-motor training compared to the control group.   "
75889|NCT02292498|"     The purpose of this study is to test the feasibility of using thermal images to diagnose     bacterial pneumonia instead of a chest x-ray in the future. More specifically, the objectives     of this study are: 1) to determine if thermal imaging, using a commercial thermal camera can     detect areas of heat emitted from the chest in similar locations to where a chest X-ray shows     focal consolidation consistent with bacterial pneumonia; 2) to evaluate whether changes in     heat emitted from the chest changes over time if it is possible to obtain serial images of     the chest.   "
75890|NCT02292485|"     Investigators will administer a brief, anonymous survey at the Texas Academy of Family     Physicians (TAFP) annual Primary Care Summit to better understand the readiness of primary     care physicians in Texas to implement lung cancer screening programs in their practice     settings.   "
75891|NCT02292472|"     This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding     Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric     Hypertrophy.   "
75905|NCT02292290|"     Dual therapy with metformin and Liraglutide is more effective at helping people with     established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite     endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no     severe hypoglycaemic events.   "
75892|NCT02292459|"     The purpose of this study is to evaluate the complete resolution of constipation in     participants taking PEG 3350 compared to those taking PEG 4000, based on analysis of the     number of bowel movements from self-reported bowel movement (BM) data. The complete     resolution of constipation is defined as the elimination of straining or of hard/lumpy     stools.   "
75893|NCT02292446|"     The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) is     to provide early access to ruxolitinib and evaluate safety information in patients with PV,     who are HU resistant or intolerant and who have no other standard treatment option, nor do     they qualify for another clinical study for PV.   "
75894|NCT02292433|"     Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics     of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As     Monotherapy   "
75895|NCT02292420|"     The purpose of this study is to determine the normal reference values of pulse oximetry     plethymographic waveform parameters in Chinese population.   "
75896|NCT02292407|"     This study aims at providing first evidence that axillary clearance by using an operation     technique including the precise LigaSure instrument and closure of dead space of the axilla     will result in an operation were a drain is not necessary and the need for seroma evacuation     after surgery is very limited.   "
75897|NCT02292394|"     Caring for dependent persons can give rise to depression in non-professional caregivers,     placing a burden on health care services and threatening the quality of the care dispensed to     the dependent. Unfortunately, the ability of these patients to attend therapy sessions is     often limited precisely by their role as caregivers. Preventive measures that are accessible     to caregivers are thus called for. The primary aim of this project is to evaluate the     efficacy of telephonic administration of a brief indicated preventive psychological     intervention for depression that in previous work proved effective when administered in     person in group sessions. With a view to optimizing resource usage by maximizing     interventional efficacy, the secondary aim is to determine the contribution to overall     efficacy of that part of the intervention that consists in increasing pleasant activities. To     these ends, some 180 informed, consenting caregivers satisfying appropriate criteria for     inclusion in the study will be randomized to one of three interventions (≈ 60 participants     per intervention): the full cognitive-behavioural programme; a program focused only on the     component of pleasant activities; or a usual care condition. Both programmes will be     administered in five 90 minute sessions by audio tele-conference. All sessions will be     recorded for verification of adherence to the intervention protocols. Participants will be     re-evaluated at the end of their intervention (when participant satisfaction with the     cognitive-behavioural programmes will also be assessed) and also 1, 3, 6 and 12 months later;     all evaluations will be performed by trained interviewers who will be blind to the aims of     the study, the interventions employed, and the group to which any given participant belongs.     Analyses of these evaluations will compare the short- and long-term efficacies of the three     groups. Factors that mediate participant improvement or predict results will also be     investigated, and the cost-effectiveness of the interventions will be estimated.The central     hypothesis of the proposed study is that a multicomponent cognitive-behavioral telephone     intervention and a protocol assessing participation in pleasant activities will both     significantly reduce the incidence of depression and depressive symptoms compared to a     control group with usual care immediately after treatment and at 1-, 3-, 6-, and 12-month     follow-up visits.   "
75898|NCT02292381|"     Glaucoma is one of the leading causes for blindness in industrialized countries. It is     characterized by a progressive loss of retinal ganglion cells, morphological changes in the     optic nerve head and a characteristic loss of visual field. Although increased intraocular     pressure has been identified as the major risk factor for the development and the progression     of the disease it has been speculated for a long time that impaired ocular blood flow may     contribute to the pathogenesis of the disease. This concept has been supported by several     epidemiological studies showing that low ocular perfusion pressure and small retinal vessel     caliber are associated with the disease.      The proposed study tests the hypothesis that patients with glaucoma have reduced total     retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood     flow will be investigated during an increase in ocular perfusion pressure. This is of     importance because it may clarify the degree of vascular involvement in glaucoma.   "
75899|NCT02292368|"     The goal of this clinical research study is to learn which areas of the brain respond to     acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck     cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve     patient quality of life.   "
75915|NCT02292160|"     The objective is to determine if data from the National Insurance Health card (giving     antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk     of antibiotic resistance and to identify population groups for which probabilistic     antibiotics regimen of urinary tract infection could be simplified   "
75916|NCT02292147|"     Descriptive and prognosis study of the functional outcome after cardiac arrest for the     patients awake within the first 15 days.   "
77238|NCT02274857|"     The study is a prospective, multicenter, randomized, single-blinded study to assess the     safety and effectiveness of FIRM procedures followed by conventional ablation including PVI     versus a standard PVI procedure for the treatment of persistent atrial fibrillation.   "
75900|NCT02292355|"     Introduction: the influence of temporomandibular disorders (TMD) related to postural changes     are yet no consensus, but it is believed that the imbalances of a system can influence     another. Several techniques have been used to treat TMD and its associated problems, however     there is a paucity of studies evaluating the effects of global treatments, such as Pilates,     in individuals with TMD literature. Objective: To evaluate changes in the level of pain, the     severity of TMD, the EMG activity of masticatory muscles and posture of young women     undergoing training in Pilates, as well as correlating postural changes, pain level, severity     of TMD and EMG activity of masticatory muscles. A randomized clinical trial with blinded     assessors will be held. 40 patients divided randomly into two groups will be assessed, the     control group (CG) who receive conventional treatment with occlusal splint and intervention     group (IG), which in addition to conventional treatment will undergo Pilates sessions. Both     groups will be formed for women aged 18 to 35 years with TMD and pain. The IG will receive     treatment with the Pilates Method for 15 weeks with frequency of twice weekly and use     occlusal splint as directed by the dentist. The CG will make use of occlusal splint alone. At     the beginning and end of the 15 weeks the individuals are evaluated to verify the presence of     TMD, TMD severity, pain, EMG evaluation of masticatory muscles and body posture. Data will be     analyzed statistically.   "
75901|NCT02292342|"     Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level     doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 & 1.0 mg/kg BW) in healthy men.   "
75902|NCT02292329|"     The purpose of this study is to carry out a randomized double blind controlled trial in 30     male subjects to investigate the effect of acai consumption on acute changes in vascular     function, and to other cardiovascular markers. As a secondary aim the study will allow us to     characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour     period.   "
75906|NCT02292277|"     Patients with myocardial infarction, which does not include all layers of the heart's muscle     wall are common and they often receive pharmacological treatment with the platelet inhibiting     drug ticagrelor. However, the drug uptake after an oral dose of 180mg ticagrelor has not been     thoroughly studied in these patients.      The present study will evaluate ticagrelor uptake and platelet aggregation after a 180 mg     loading dose ticagrelor in these patients.   "
75907|NCT02292264|"     The aim of this study is to evaluate risk factors and complications of ventral hernia repair.     A retrospective study of journal files with patients undergoing ventral hernia repair, and an     analyses of complications by use of the Clavien-Dindo classification of surgical     complications.   "
75908|NCT02292251|"     Stroke often results in limitation of arm movements, from which many people do not fully     recover. We believe that early and intensive therapy is important to enhance recovery of arm     movements after stroke. We are doing this research study to see how much arm movements     improve with intensive therapy in patients have had a stroke in the past 6 weeks.   "
75909|NCT02292238|"     General Investigational Plan      Study Objectives The goal of this proposal is to determine whether enhancing brain glucose     utilization minimizes cognitive decline in patients with Amnestic Mild Cognitive Impairment     (AMCI) or mild Alzheimer's disease (AD) dementia. We propose a proof of concept double-blind,     placebo controlled pilot study to determine if increasing brain thiamine availability with     the investigational new drug benfotiamine, will minimize the decline in glucose utilization     and slow the cognitive decline associated with the progression AMCI/AD dementia.      Specifically, our objectives are two-fold:        -  To test whether increasing brain thiamine by administering 600 mg per day (300          mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline          in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).        -  To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning          and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain          glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron          Emission Tomography(FGPET) in the posterior cingulate.      We will also carry out the following secondary objectives:        -  Assess if there are differences in secondary clinical outcome measures (NPI, ADCSADL,          CDR, Buschke) between benfotiamine and placebo groups and whether specific cognitive          domains (ie: activities of daily living, learning and memory verbal memory, behavioral,          etc.) are driving these changes.        -  Compare ADAS-COG change scores in the benfotiamine and placebo groups within and between          strata that were defined by initial cognitive impairment, to attempt to identified the          population that most benefits from benfotiamine.        -  Compare changes in glucose utilization between the benfotiamine and placebo groups in          secondary Regions of Interest (ROIs) including the hippocampus, prefrontal regions and          entorhinal cortex.        -  Compare changes in whole brain glucose utilization between the benfotiamine and placebo          groups using statistical parametric mapping (SPM).        -  Assess the correlation between changes in glucose utilization with changes in ADAS Cog.        -  Determine if ApoE4 genotype alters the response to benfotiamine.   "
75910|NCT02292225|"     To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in     combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic     Lymphoma previously treated with a BTKi.   "
75911|NCT02292212|"     The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21)     .   "
75912|NCT02292199|"     Hypertension has high prevalence and poor control rates and is considered one of the major     modifiable risk factors for cardiovascular system diseases, and one of the most important     public health problems. The imbalance of the autonomic cardiovascular control, which can be     considered as a major etiologic factor in the development of essential hypertension is     characterized by increased sympathetic activity and reduced parasympathetic activity     possible.      Cardiovascular disease is the leading cause of death and disability in the world and     autonomic imbalance is associated with several pathological conditions, and may be a final     common pathway for the increased morbidity and mortality of cardiovascular diseases. In this     sense, the heart rate variability (HRV) is a quantitative marker of sympathetic and     parasympathetic activity, which can be used to assess disease and mortality as a noninvasive     technique.      TENS is a noninvasive therapeutic modality, easy to handle, it has no side effects or     interactions with medications being used for the relief of pain by sensory stimulation     through peripheral nerves and mainly for control and treatment of acute and chronic pain .     Research on the effect of TENS on the sympathetic and parasympathetic nervous system activity     remain controversial, especially regarding the parameters to use.      The aim of this study is to investigate the effects of TENS on the sympathetic and     parasympathetic nervous system in patients with hypertension by heart rate variability and     blood pressure variability.      This is a randomized clinical trial, double blind, where hypertensive patients were     randomized to three groups: high-frequency TENS (100 Hz) n = 20, low frequency TENS (4 Hz) n     = 20 and n = 20 placebo. Evaluations will be made in a single session. The results will be     assessed by a blinded investigator and randomization will be done electronically.      It is expected to evaluate how often TENS exerts more influence in the modulation of     sympathetic and parasympathetic system.   "
75917|NCT02292134|"     Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors     involved in poor sleep quality are environmental factors, such as light and noise, which are     an unavoidable consequence of cares.      The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep     architecture and quality in ICU patients.   "
75918|NCT02292121|"     In rodents, obesity is associated with changes in tight junctions' structure in small     intestine, which impacts intestinal permeability and results in metabolic complications. Few     data exist in human. We hypothesized that intestinal permeability is altered in obese     subjects in comparison to lean subjects, linked to metabolic and inflammatory status and that     these alterations are modified after gastric bypass.   "
75919|NCT02292108|"     High food impulsiveness, impaired food reward and stress response are involved in the     phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a     complementary medicine which is recognized as effective for defined indications. Complexity     and diversity of methodological studies with hypnosis does not allow to conclude on its     efficacy in treating this disease.      In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and     self-hypnosis practice would improve food disinhibition assessed by an adapted questionary     (TFEQ 51).   "
75920|NCT02292095|"     The incidence of post-operative pain after open inguinal hernia repair is high and impair the     quality of lives of the patients.The purpose of this study is to determine whether transverse     abdominis plane block combined with intravenous patient controlled analgesia is superior to     intravenous patient controlled analgesia in improving the quality of life and reducing the     incidence of chronic post-surgical pain   "
75921|NCT02292082|"     Total knee replacement is associated with severe post-operative pain. The purpose of this     study is to compare two methods of treatment for pain control following Total Knee     Replacement with an accelerated physical therapy protocol to aid the achievement of rehab     milestones.   "
75922|NCT02292069|"     This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium     Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate     and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland     in healthy, adult,human subjects under Fed conditions.   "
75970|NCT02291445|"     This is a pilot study to compare the relative bioavailability between two peppermint oil     formulations, namely a colon-targeted-delivery capsule (Tempocol-ColoPulse®) and an     enteric-coated capsule (Tempocol®). This study is conducted as part of a future multicenter     randomized controlled trial that will assess the therapeutic effect of the new peppermint oil     formulation in IBS patients.   "
75923|NCT02292056|"     There is currently limited research that addresses the unique medication safety and family     planning needs among women of reproductive age with psychiatric conditions. The study will     research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford     Clinic in the Department of Psychiatry at UCSD that will help women in this population better     understand: 1) which of their medications are safe to use in pregnancy, 2) provide education     regarding the importance of using contraception and which contraceptive choices are available     to them, and 3) raise awareness of any drug-drug interactions that may exist between their     medications and their chosen method of contraception. Patients will be given questionnaire to     assess their contraceptive utilization. They will also be given a before and after quiz to     allow for an objective measure of the patient's increase in knowledge regarding medication     safety and contraceptive choices as a result of the investigators intervention.   "
75924|NCT02292043|"     The investigators would evaluate the effects of the novel method, HTEA on cardiac function in     the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial     infarction.   "
75925|NCT02292030|"     The purpose of this study is to explore the efficacy of low energy cardioversion on atrial     fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.   "
75927|NCT02292004|"     This study will assess the safety and early efficacy of a newly developed device,     bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.)     Ten participants will undergo surgery with the new device (Experimental Group) and 10 will     undergo a standard ACL reconstruction surgery (Control Group.)   "
75928|NCT02291991|"     This is a randomized, placebo controlled, single dose study to assess the safety,     tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.   "
75929|NCT02291978|"     The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity     focused ultrasound device as an intervention for treatment of facetogenic lower back pain.   "
75930|NCT02291965|"     Specific Aim 1: To determine whether endogenous metabolomics-based biomarkers obtained before     IV BU administration can predict IV BU clearance.      Specific Aim 2: To characterize IV BU metabolism by metabolomics.      Specific Aim 3: To identify covariates influencing IV BU pharmacokinetics.   "
75931|NCT02291952|"     The goal of this application is to determine whether changing the timing of food intake     prevents the adverse metabolic effects of circadian misalignment.   "
75932|NCT02291939|"     The objective of the clinical trial is to determine the suitability of the FMwand     Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.   "
75933|NCT02291926|"     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord     mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.   "
75948|NCT02291731|"     To evaluate the clinical effect of combination of topical 20% (v/v) autologous serum eye     drops and a silicone-hydrogel contact lens (CLs) in the treatment of recalcitrant persistent     epithelial defects (PEDs) and the recurrence rate of epithelial breakdown with or without     continued use of autologous serum eye drops.   "
75934|NCT02291913|"     Many patients with ER-positive or PR-positive breast cancer are treated with endocrine     therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients     often experience disease progression. Everolimus, in combination with exemestane, has shown     activity in endocrine-resistant disease. This study will evaluate the efficacy of Everolimus+     anti-estrogen therapy in patients with ER-positive metastatic breast cancer who have     progressed after receiving anti-estrogen therapy.   "
75935|NCT02291900|"     The purpose of this study is to determine if surgical angiogenesis performed in talar     avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior     technique compared to core decompression and nonvascularized osseous autografts.   "
75936|NCT02291887|"     A cohort of patients responsive to treatment with ranibizumab but resistant to      aflibercept were identified in a previously conducted retrospective study. Identified      patients will have their blood drawn for genome wide sequencing. The sequencing      data will be compiled and analyzed in an attempt to identify a common genetic basis      for patients susceptible to ranibizumab but resistant to aflibercept.   "
75937|NCT02291874|"     Purpose of this study is to evaluate the Long-term Safety, Tolerability, and Efficacy of     Ipragliflozin in Combination with GLP-1 Receptor Agonists in Japanese Patients with Type 2     Diabetes Mellitus Who Have Inadequate Glycemic Control with GLP-1 Receptor Agonists.   "
75938|NCT02291861|"     The purpose of this study is to determine whether fixed-doses of an investigational drug,     SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of     tardive dyskinesia.   "
75939|NCT02291848|"     This study is for patients that have a cancer called Multiple Myeloma. This research study     uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T     lymphocytes (CTLs), a new experimental therapy.      The proteins that investigators are targeting in this study are called tumor associated     antigens (TAAs). These are cell proteins that are specific to the cancer cell.They either do     not show or show up in low quantities on normal human cells. In this study we target five     common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol,     patients have been treated and so far this treatment has shown to be safe.      Investigators now want to try this treatment in patients with multiple myeloma.      These TAA-specific CTLs are an investigational product not approved by the Food and Drug     Administration.      The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn     what the side effects are, and to see whether this therapy might help patients with multiple     myeloma.   "
75971|NCT02291432|"     To study the safety of autologous muscle-derived cells (AMDC) for the treatment of male     stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.   "
75973|NCT02291406|"     Insulin resistance is a key reaction to surgery and trauma and reflects the degree of     metabolic stress. With greater degree of insulin resistance the development of complications     increase, in particular infectious complications. The aim of this study is to determine if     robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to     abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic     clamp method. In addition inflammatory factors and clinical recovery will be measured.   "
75940|NCT02291835|"     Periodontitis is a chronic inflammatory disease and a significant risk factor for tooth loss.     While a link between diet and periodontal health exists, the relationship between diet and     healing following periodontal therapy has yet to be investigated.The objective of this study     was to determine if higher intakes of foods and nutrients with antioxidant or     anti-inflammatory activity are associated with reduced probing depth following sanative     therapy. Sanative therapy is a first line cost-effective treatment to manage periodontal     disease and thus prevent tooth loss. Patients with chronic generalized periodontitis     undergoing sanative therapy were recruited for the study. Mean probing depth was assessed at     baseline and 8-16 weeks following sanative therapy. Dietary intakes of fruits, vegetables,     vitamins and dietary fats were estimated using the Block 2005 food frequency questionnaire     and supplement use was recorded using a questionnaire. A small venous blood sample was also     collected at baseline to measure serum 25-hydroxyvitamin D concentrations.   "
75941|NCT02291822|"     Collection of already existing data and images for patients < 2 years of age having     MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during     a prospectively designed blinded reading of the images.   "
75942|NCT02291809|"     The primary objective is to compare & evaluate between the treatment groups the changes in     decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the     adult Remune dose vs the low dose Remune placebo groups. Additional objectives include     changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.   "
75943|NCT02291796|"     Introduction: Plasma fibrinogen levels have been identified as an important risk factor for     cardiovascular diseases and could have a prognostic value. Bezafibrate decreases fibrinogen     levels and also the incidence of major cardiovascular events in primary prevention, but its     effects in acute coronary syndrome is unknown.      Hypothesis: Bezafibrate effect over statin therapy reduces fibrinogen concentrations,     inflammatory response and clinical events, in patients with ST segment elevation ACS and     hyperfibrinogenemia.      Methods: In a randomized clinical trial, controlled with conventional therapy. Patients with     ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500     mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day (group I n=50)     or just conventional therapy (group II n=50). Serum fibrinogen, c reactive protein and     cytokines were measured. Clinical end points were recurrence of angina or infarction, left     ventricular failure, cardiovascular mortality and combined end points during hospitalization.   "
75944|NCT02291783|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor     agonist intended for the treatment of cognitive disorders.   "
75945|NCT02291770|"     Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of     second line immunosuppressive agents have been investigated but no optimal treatment has     emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells     (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate     of 70% in steroid- refractory patients. In the present randomized study the efficacy and     safety of MSC treatment will be further studied in patients with cGvHD.   "
75946|NCT02291757|"     Objectives:      Primary: To evaluate the efficacy of NEM® versus placebo in improving joint pain and     stiffness in subjects with knee osteoarthritis. Western Ontario and MacMaster Universities     Osteoarthiritis Index (WOMAC)), Likert Scale, Range of Motion (ROM) evaluation and Visual     Analogue Scale (VAS Scale) will be used as joint pain and stiffness scales for efficacy.      Secondary: To evaluate the safety and tolerability of NEM® treatment.   "
75947|NCT02291744|"     The primary endpoint is to evaluate the TFS (time to failure of strategy).   "
75949|NCT02291718|"     The purpose of this study is to compare the contrast agents and imaging techniques used for     thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and     adjusted based on the contrast agent, since contrast agents have varying iodine     concentrations. If the contrast iodine concentration is higher, it may be possible to adjust     the imaging parameters and lower the overall radiation dose to the patient.   "
75950|NCT02291705|"     Inguinal hernia repair is one of the common day-case surgery in children. The aim of this     study is to compare the effects of ultrasound guided rectus sheath block and intravenous     tramadol on peroperative anesthetic requirement and postoperative analgesia.   "
75951|NCT02291692|"     The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral     block with bupivacaine on both perioperative anesthetic agent consumption and postoperative     analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.   "
75952|NCT02291679|"     The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug     administered once daily to patients with chronic idiopathic constipation (CIC). The primary     efficacy parameter is the percentage of participants in each dosing group that meet the     protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.   "
75972|NCT02291419|"     The purpose of this pilot study is to establish the rate of cardiovascular events in patients     with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy     and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients.      Data from current studies suggest that myocardial injury detected by minor elevations in     troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and     is associated with an increased risk of mortality at 30 days and 1 year. There are no current     guidelines for care of patients with elevated troponin levels in the absence of acute     coronary syndrome. This study will assess if the increased risk of these patients is     modifiable by an anti-platelet medication and evaluate the safety of this medication.      Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet     medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months,     with the last contact at one month post treatment discontinuation.   "
75974|NCT02291393|"     The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80     lead ECG may increase the specificity and sensitivity in diagnosing this potentially life     threatening inherited cardiac condition. This pilot would form the basis of a much larger     clinical trial to test the utility of this novel diagnostic tool.   "
75953|NCT02291666|"     Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and     cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive     characterization of the effects of T2D on the expression and activity of major CYP450s. In     our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia     are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and     macro-vascular complications and inadequately controlled T2D due to high intersubject     variability in drug disposition and action.      Characterization of the effects of T2D on drug metabolism capacity will be performed using a     cocktail of CYP450 probe drugs.      CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D     patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42     non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe     drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2),     bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6),     midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1).     Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated     and compared between three groups of subjects. Other co-variables to be studied include T2D     biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and     inflammatory markers.      Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the     activity of major CYP450s. Moreover, this project will indicate to us whether glycemic     control should be considered as a covariate of intersubject variability in drug metabolism     capacity.   "
75954|NCT02291653|"     We hypothesized that the McGrath MAC EMS is beneficial for intubation of pediatric manikins     while performing CPR. In the current study, we compared effectiveness of the McGrath MAC EMS     and MIL laryngoscopes in child resuscitation with and without CC.   "
75955|NCT02291640|"     The aim of this study was to compare time, success rates of video laryngoscope and direct     laryngoscope for the emergency intubation with an immobilized cervical spine in a     standardized pediatric manikin model.   "
75956|NCT02291627|"     The aim of this study was to compare time, success rates of different video laryngoscopes for     the emergency intubation with an immobilized cervical spine in a standardized pediatric     manikin model.   "
75957|NCT02291614|"     The purpose of this Phase 1 study is to determine if AMG 211 given as a continous IV infusion     is safe and tolerable in adult subjects that have advanced gastrointestinal adenocarcinoma.     The study will be conducted in multiple sites and test increasing doses of AMG 211. The     safety of subjects will be monitored by intensive assessment of vital signs,     electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by     the usual imaging procedures and their interpretation.   "
75958|NCT02291601|"     Demonstrate the reduction of bacteria on the skin.   "
75959|NCT02291588|"     This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811     single subcutaneous and intravenous dose to subjects with SLE   "
75960|NCT02291575|"     The rural healthcare market in much of the developing world is composed largely of informal     private providers. These private providers often have little to no certifiable medical     training. Recent studies in India using medical vignettes (or hypothetical medical     situations) to measure clinical competence and direct observations of doctor-patient     interactions to measure clinical practice highlight the poor quality of care that most     patients receive—a problem that is clearly relevant beyond India and affects most low-income     countries worldwide. For instance:        1. In rural India, standardized patients presenting with chest pain and (on further          questioning) radiating pain in the arm are (correctly) diagnosed with a heart attack in          less than 25 percent of cases.        2. Across 8 low and middle-income countries, health care providers completed the four          necessary vital statistics for new patients in less than 4 percent of interactions:          health care providers in the public sectors of many developing countries routinely spend          less than 1 minute per patient.      To address these deplorably low standards in both medical knowledge and practice, the Liver     Foundation in Kolkata has been working with private rural health care providers through     capacity building activities to improve quality in the private sector. The program consists     of multiple-week training to private rural health care providers on the basis of a     well-developed curriculum in the district of Birbhum, West Bengal.      This study aims to assess the impact of this training program using a randomized evaluation,     in which providers are randomly assigned to the treatment, i.e. the Liver Foundation's     training program, or the control, i.e. no such training. As an independent outside evaluation     team, we will run a baseline survey for all providers (through a third party data collection     agency), monitor the application of and compliance in the Liver Foundation's training     intervention, and conduct a final endline study. By comparing the treatment and control     groups on a variety of measures developed to capture competence in provider knowledge and     practice, we can rigorously assess whether such a training program for informal rural health     care providers is an effective means of improving provider medical knowledge and practice in     the short run. It is worth noting that this study will not be able to capture long run     effects , such as price or location changes, on health care for the rural poor.   "
76141|NCT02289196|"     Patients with histologically proven malignancy with documented disease control (objective     response or stable disease) or Not Evaluable Disease (NED) expectancy > 6 months; only     HLA-A*02 positive patients.      The primary objective of the trial is to compare safety and tolerability of four different     doses of Vx-006. The secondary objective is to compare immunogenicity of four different doses     of the Vx-006.   "
75961|NCT02291562|"     THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC can     induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has anxiolytic     and possibly antipsychotic properties, while not impairing memory and other cognitive     functions. Instead, CBD has been shown to have significant neuroprotective effects. In     humans, CBD values correlated positively with gray matter concentration in bilateral     hippocampus. Recent data from experimental animals and in vitro studies suggest that these     distinct effects might be caused by opposing effects on brain cannabinoid receptors.      Neuroimaging studies have consistently identified brain activity recorded at prefrontal and     medial temporal regions as relevant for episodic memory. Additionally, the abundance of     cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices     suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the     evidence relating cannabinoids to these conditions is relatively recent and has been obtained     from either biochemical or pharmacological studies. It might be hypothesized that CBDs could     be useful to delay or even arrest the progression of functional and structural neuronal     degeneration.      The investigators will use an episodic memory paradigm to test the effects of THC, CBD and     placebo on memory encoding and retention and the underlying neuronal networks on healthy male     subjects.   "
75962|NCT02291549|"     The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled,     multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery     but present with recurrent sinus obstruction.   "
75963|NCT02291536|"     Attentional blink refers to a phenomenon where the detection of the second of two target     stimuli that are presented in Short succession within a stream of stimuli is impaired. This     is explained by an insufficient availability of attentional resources. Additionally,     emotionally salient stimuli, like for example pictures with a positive or negative content,     are detected more often compared to neutral pictures during this attentional blink period.      Cannabinoids are involved in the modulation of cognitive, attentional, and emotional     processes. Interestingly, data from animals suggests that THC and CBD, both active     ingredients in the Cannabis sativa plant, have opposing effects on brain cannabinoid (CB1)     receptors. CB1 receptors modulate the expression of emotionally salient conditioned     association in rats, if salience processes in humans are modulated in the same way remains     unclear.      Employing a task to detect salient stimuli, Bhattacharyya et al. (2012) showed that THC seems     to make non-salient standard stimuli more salient. They showed decreased activation of the     right caudate and increased right prefrontal cortex stimuli during processing of salient     stimuli. Importantly, this was associated with decreased response times to standard relative     to oddball stimuli. Generally, THC and CBD differentially modulate brain areas associated     with attentional salience processing. For example THC seems to increase prefrontal and     striatal activation whereas CBD seems to decrease it.      The investigators assume that THC increases the number of correctly detected emotional     stimuli during the attentional blink period, whereas CBD has no effect. Additionally, the     investigators assume that pictures of the positive category are detected with higher accuracy     than negative ones under the influence of THC.   "
75964|NCT02291523|"     Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double     blind, placebo controlled study. The safety and efficacy of the intervention will be closely     monitored.   "
75965|NCT02291510|"     This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release     metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR,     ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.   "
75966|NCT02291497|"     Hypophosphatasia (HPP) is a rare, inherited metabolic disease caused by inactivating     mutations in the Alkaline Phosphatase (ALPL) gene, coding for the Tissue-nonspecific alkaline     phosphatase (TNAP). Penetrance and disease severity is very heterogenous, ranging from     stillbirth to adult-onset manifestations. Especially the latter are again characterized by an     extremely broad spectrum of symptoms. This scope of variability makes it difficult to     attribute individual patients' symptoms to the disease and distinguish them from HPP     independent health issues. Especially in adult HPP patients, musculoskeletal problems,     including (fragility-) fractures / bone bruise, joint pain, reduced mobility, muscular     weakness and pain and reduced muscular endurance appear to reflect the prevailing burden of     disease, especially with respect these patients dis-abilities of daily life.      To expand current knowledge of the natural history of the disease as well as on disease     specific musculoskeletal deficits in HPP, all adult patients with established Diagnosis of     HPP known at the Orthopedic Institute, University of Würzburg, will be offered to participate     in a single, multimodal assessment of their disease history, current symptoms and     disabilities, lab evaluations and clinical and technical analysis of their musculoskeletal     status and capabilities.      Patients will be invited to a day long visit to the clinic in order to perform the following     assessments:      A) Epidemiologic / anamnestic information B) Physical examination C) Structured     questionnaires D) Laboratory examinations E) Clinical functional testing F) Technical     Examinations   "
75967|NCT02291484|"     Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with     standard stress testing in patients with stable chest pain complaints.   "
75968|NCT02291471|"     The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult     Chinese Volunteers.   "
75983|NCT02291276|"     In this prospective, observational study the investigators assess the perioperative course of     right ventricular function in combination with the venous return in patients undergoing major     non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac     surgery develop an impairment of right ventricular function and/or venous return.     Furthermore, the study evaluates if an impairment of right ventricular function and/or venous     return is associated to left ventricular function, arterial side of the circulation and to     postoperative clinical outcome.   "
75984|NCT02291263|"     This study will be an open-label phase III randomized clinical trial comparing different     combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV     administered at 6 weeks or 14 weeks or 6 and 14 weeks of age. All participants will also     receive bOPV at 6, 10 and 14 weeks of age.   "
76142|NCT02289183|"     The purpose of this study is to explore the clinical application value of modified     delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.   "
75969|NCT02291458|"     The South Asian population is facing an epidemic of type 2 diabetes, of which the underlying     cause is still unknown. It is currently hypothesized that an ethnic susceptibility towards a     disturbed energy metabolism may underlie this disadvantageous metabolic phenotype. In line     with this, the investigators recently discovered that Dutch South Asian subjects have 32%     lower resting energy expenditure (REE) and 34% lower energy-combusting brown adipose tissue     (BAT) compared to matched white Caucasians. Nitric oxide (NO) was recently shown to be     crucial for BAT development and, interestingly, South Asians have diminished NO     bioavailability. Thus, the disadvantageous metabolic phenotype in South Asians may be caused     by diminished NO bioavailability resulting in lower BAT volume. Therefore, the investigators     hypothesize that increasing NO generation in the body by administration of L-arginine, the     precursor of NO, will improve their metabolic phenotype by increasing BAT volume, thereby     increasing REE and clearance of triglycerides and glucose by BAT. To investigate this, the     investigators will perform a randomized placebo-controlled multicenter cross-over study in     moderately obese Dutch South Asians and matched white Caucasians. Subjects will receive     L-arginine (9 gram/day) or placebo for 6 weeks, followed by a wash-out period of 4 weeks and     then again 6 weeks of one of either treatments. At the end of both treatment periods, a     cold-induced PET-CT scan will be performed. Furthermore, muscle and fat biopsies will be     obtained and thermoregulation will be assessed.   "
75975|NCT02291380|"     A study, multi-center, randomized, double-blind, placebo parallel-controlled method, will be     carried out to evaluate the safety and efficacy of Botulinum Toxin Type A for injection     (HengLi®) for prophylactic treatment with chronic migraine in adults. In the core phase, two     treatments of HengLi® or the placebo will be administrated (randomized at a ratio of 2:1, the     target number is 288 subjects). In the extension phase, three treatments of HengLi® will be     still administrated on 288 subjects recruited ever.   "
75976|NCT02291367|"     This study were to compare the relative bioavailability of Duloxetine HCl delayed release     capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed     release capsule 60 mg) in healthy, adult, human subjects under fasting conditions and to     monitor safety of subjects   "
75977|NCT02291354|"     The purpose of this study is to evaluate the synergism of Soluble Dietary Fiber with Fecal     Microbiota Transplantation in Adult Patients with Slow Transit Constipation.   "
75978|NCT02291341|"     This study were to compare the relative bioavailability of Duloxetine HCl delayed release     capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed     release capsule 60 mg) in healthy, adult, human subjects under fed conditions and to monitor     safety of subjects   "
75979|NCT02291328|"     Brassica vegetables are an important part of the investigators normal diet and are associated     with a reduced risk of many chronic diseases. The protective effect may be as a result of the     hydrolytic products of compounds contained within these vegetables, called glucosinolates.     There is evidence that consumption of Brassica vegetables may cause compositional changes to     the investigators gut microbiota. The aim of this study is to see whether a diet rich in     Brassica alters the human gut microbiota composition, and specifically whether it causes an     increase in the number of the beneficial bacteria known as lactobacilli.   "
75980|NCT02291315|"     Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis.     However, postmenopausal Thai women consume diets which are habitually low in calcium due to     lactose intolerance and dietary patterns which typically do not include milk-based products.     The primary goal of this study is to measure the fractional calcium absorption from milk and     a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with     habitually low calcium intakes. The secondary objective is to determine associations between     calcium absorption and biomarkers which impact vitamin D status and bone metabolism.   "
75981|NCT02291302|"     The investigators goal is to determine the efficacy of school/classroom based environmental     intervention in reducing asthma morbidity in urban schoolchildren.   "
75985|NCT02291250|"     Dietary strategies for alleviating health complications associated with type 2 diabetes (T2D)     are being pursued as alternatives to pharmaceutical interventions. Berries such as     blackcurrants that are rich in polyphenols may influence carbohydrate digestion and     absorption and thus postprandial glycaemia. In addition berries have been reported to alter     incretins as well as to have anti-oxidant and anti-inflammatory properties that may also     affect postprandial glycaemia. This study investigated the acute affect blackcurrants on     glucose metabolism in overweight/obese volunteers .   "
75986|NCT02291237|"     This study will evaluate the effect of eleclazine (GS-6615) on exercise capacity, quality of     life, and safety and tolerability of eleclazine in participants with symptomatic hypertrophic     cardiomyopathy (HCM).   "
75987|NCT02291224|"     This trial will evaluate a multi-component, clinic-based intervention aimed at increasing     dual protection strategy selection and adherence among young African American females at an     urban family planning clinic. Dual protection is the use of contraceptive strategies to     prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is     an unblinded randomized controlled trial; participants will either get the interactive     multimedia platform focused on DP strategies with intervention arm counseling or the standard     of care arm counseling.      The study will recruit 710 African American females aged 14-19 who are attending the Grady     Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health     care.      The trial will recruit and enroll 710 young women presenting to the clinic for clinical care     who have the following characteristics:        -  self-identify as African American,        -  14-19 years of age,        -  have had vaginal sex with a male partner in the past 6 months,        -  HIV-negative by self-report,        -  not pregnant,        -  no desire to be pregnant in next 12 months,        -  plan to stay in the Atlanta area for the next year,        -  are willing to provide contact information, and        -  were not previously enrolled in the pilot study of this intervention.      Those enrolled will be in the study for 12 months. Young women who are eligible and give     written consent or assent for study participation will be enrolled. Half will be randomized     to the control arm, half to the intervention arm.        1. Control arm (standard of care) includes individual clinical care and standard of care          counseling consistent with protocols at the TSC, with study visits for data collection          at enrollment, 6 months, and 12 months, during which any medical care or counseling that          they would normally get will also be provided. Control arm participants will also get          telephone calls from clinic staff to update their contact information and remind them of          upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5          months after the 6 month visit.        2. Intervention arm, consisting of the following intervention components:             1. Enrollment visit                  -  A culturally-appropriate interactive multimedia platform focused on DP                    strategies and designed to prepare the individual for selection of a DP                    strategy.                  -  Individual intervention arm counseling to select the DP strategy that is best                    suited for the participant (by a clinic health care provider).                  -  Individual intervention arm counseling to build skills for correct and                    consistent use of the selected DP strategy (by a nurse educator (NE)).             2. Booster counseling via phone at about 3 weeks and 5 months after the enrollment               visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE).             3. 6 month visit                  -  An abbreviated version of the interactive multimedia platform focused on dual                    protection strategies and strategy adherence.                  -  Individual intervention arm counseling to reinforce skills for correct and                    consistent use of the DP strategy (by an NE).      At the final study visit at 12 months there is no difference between the counseling provided     to the two groups; participants in both arms will receive the clinic standard of care.      Participants in both arms of the study will follow the same data collection procedures     throughout the study:        -  At all three study visits, participants in both arms will receive urine pregnancy and          STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire.        -  At 3 and 9 months after enrollment, participants in both arms will receive a data          collection call with administration of a telephone questionnaire.      Throughout the study, all participants will be encouraged to come in for evaluation if they     have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will     be later collected via chart review. If participants seek reproductive health care at other     facilities during the study period, records will be requested with participant permission,     and data from pregnancy or STI testing at these outside clinic visits will be collected via     review of records received.      We will examine the efficacy of the intervention arm relative to control arm across the     following primary behavioral and biologic outcomes over the 12 months of follow-up:        1. Self-reported dual protection strategy selection        2. Self-reported dual protection strategy adherence        3. Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as          confirmed by laboratory testing)      A small pilot study was be conducted prior to the initiation of enrollment in the main study.   "
75988|NCT02291211|"     This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic     intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery     (CRS)   "
75989|NCT02291198|"     This study will look at measuring the activity of natural killer (NK) cells using the in     vitro diagnostic device NK Vue in subjects being screened for colorectal cancer using     colonoscopy. The NK Vue diagnostic test for natural killer cell activity uses the principle     of stimulation of whole blood with a proprietary cytokine followed by the quantitative     detection of interferon gamma using an immunoassay. NK Vue is intended to be used for the     monitoring of the immune status of individuals. Measurement of NK cell activity could be a     useful tool for assessing changes in immunosurveillance in patients with conditions or     diseases where NK cell activity has been shown to be reduced, such as colorectal cancer.   "
75990|NCT02291185|"     The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery.     Hemodynamic instability is frequently encountered problem associated with BCP. In addition,     high rates of cerebral desaturation events have been reported during surgery in BCP. Although     fluid loading could alleviate hypotension associated with BCP, it may lead to volume     overload. As an alternative to static indices, dynamic preload indices such as pulse pressure     variation (PPV) and stroke volume variation (SVV) were reported to be sensitive predictors of     fluid responsivness in several surgical condition. The investigators will examine the     abilities of PPV and SVV to predict fluid responsivness during shoulder arthroscopic surgery     in BCP. Using transesophageal echocardiography (TEE), the investigators will directly     estimate the change of cardiac output during BCP.   "
75991|NCT02291172|"     Overview The goal of Comprehensive Communication Intervention for Minimally Verbal Children     with Autism is to conduct an efficacy study of a promising intervention to increase spoken     language in preschool children who are minimally verbal. The proposed study compares a     comprehensive communication intervention (JASP- EMT Plus; JEP) to a business as usual (BAU)     control group in a randomized controlled trial (RCT) across 4 time points. The study     replicates and extends procedures used by Kasari, Kaiser et al (2014) to successfully promote     social communication in older minimally verbal children. Intervention components include: (1)     Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching     (JASP- EMT), (2) applied with systematic parent training, (3) use of speech generating device     (SGD) and (4) supplementary direct teaching of foundational skills for language learning as     indicated by child entry skills (CORE-DTT; Smith, 2009). Children who remain minimally verbal     beyond age 5 are at high risk for persistent, severe communication deficits that impact     social development, educational achievement and quality of life (Tager-Flusberg & Kasari,     2013). Thus, there is an urgent need for effective strategies to promote communication     development during the preschool years to ameliorate early communication deficits and prevent     persistent minimally verbal status. This study aims to change social communication in     minimally verbal preschool children with ASD by applying a naturalistic social communication     intervention which teaches the social foundations of communication and functional use of     verbal language in play and interaction. In addition, the intervention addresses three     factors that may contribute to remaining minimally verbal: lack of an effective mode of     speech production, lack of foundational skills for learning language (receptive language,     imitation, joint attention), and lack of communication partners to support continued language     learning in natural environments.   "
76011|NCT02290912|"     This is a randomized controlled trial to develop and test the efficacy of a multi-domain     lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to     lower Alzheimer's disease risk among persons aged 40 to 64 years.   "
75992|NCT02291159|"     Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow.     The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique     to reduce spasticity and hypertonia and improve function in patients with CNS injury. The     main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor     function in patients between 45 and 80 in a chronic state after a stroke. Methods:     Double-blinded randomized clinical trial. There will be an intervention group (DNHS®     technique) and a sham control group. The intervention will be 2 sessions, one per week, in     biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis     and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and     Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ±     (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit)     in the selected variables will be calculated.   "
75993|NCT02291146|"     The overall goal of this project is to conduct a randomized controlled 12-week after school,     gardening, nutrition and cooking program (called LA Sprouts) to improve dietary intake and     reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles.     Approximately 400 3rd - 5th grade students participating in the LA's Best after school     program will participate. Four elementary schools in Los Angeles will be selected to     participate in the study. Schools will be randomized by region to either receive the     intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a delayed     intervention program one school semester later; 2 schools, n=200 students). The LA Sprouts     intervention will take place at the elementary schools, with gardens on campus specially     designed and built for this project. The program will be held once a week for 12 weeks and     will consist of a 45-minute gardening lesson, taught by Master Gardeners from the University     of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a 45-minute     nutrition education and cooking lesson, taught by USC a Nutrition Educator (supervised by     Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index (BMI) and body     fat percentages), blood pressure, metabolic function (fasting blood glucose, insulin and     lipids), dietary intake and related behaviors, and school performance will be measured before     and after the implementation of the program in both intervention and control participants.     Approximately 10 additional students of the same age will be asked to participate in a focus     group to evaluate the questionnaire developed for this study. In addition, approximately 20     additonal students of the same age will be asked to participate in a test-retest session to     validate the reliability of the questionnaire.   "
76143|NCT02289170|"     The purpose of this study is to verify the efficacy and safety of heating and cooling     combination therapeutic device (OCH-S100) for patients with chronic low back pain (LBP).   "
75994|NCT02291133|"     The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with     bleomycin in treatment of primary liver tumors in clinical study phase I and II.      The study will include 10 patients in phase I clinical study and additional 15 patients in     phase II clinical study (or in the extension of the clinical study), which will fulfill     inclusion criteria.      Treatment effectiveness will be evaluated by DCE-US or CT perfusion, to detect early events     in tumor perfusion after ECT compared to tumor perfusion before ECT. Long term effectiveness     of the treatment will be evaluated by modified RECIST criteria, which will take into account     difference in size and density, determined from images obtained by CT perfusion of the     treated tumor nodules before and after ECT. Tumor volume will be calculated by following     formula , where a will be shorter and b longer tumor diameter.      The secondary objectives of the trial are to quantify the impact of the treatment on the     patient's quality of life, tolerance to the therapy and suitability for larger study to be     conducted.   "
75995|NCT02291120|"     The objective of the study is to evaluate and compare, clinically and radiographically,the     effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary     molars.   "
75996|NCT02291107|"     In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that     strongly influence patient quality of life. The improvement of walking ability is a primary     goal for rehabilitation treatment. Current promising rehabilitative approaches for     neurological disorders are based on the concept of the task-specific repetitive training.     Hence, the interest in automated robotic devices that allow this typology of treatment for     gait training. However, studies on the effectiveness of such methodologies are still poorly     numerous in terms of functional improvement in MS patients. The aim of this controlled     cross-over study is to evaluate the effectiveness of a Lokomat gait training in patients     affected by Multiple Sclerosis in comparison to a ground conventional gait training.   "
75997|NCT02291094|"     This study aims to compare quality of perioperative analgesia of lidocaine and remifentanil     intravenously in surgical interventions for the treatment of breast cancer.   "
75998|NCT02291081|"     The HIV/HEART study (HIVH) is an ongoing, prospective, multicentre trial that was conducted     to assess the incidence, the prevalence and the clinical course of cardiovascular diseases     (CVD) in HIV-infected patients. The study population includes outpatients from specialized     HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to     have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion     into the trial. From March 2004 (Pilot phase) to May 2014 (7,5 year Follow-up) 1481 HIV+     patients were recruited in a consecutive manner. The standardised examinations included a     targeted assessment of medical history and physical examination. Blood was drawn for     comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA     levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters).     Furthermore, non-invasive tests were performed during the initial visit, including additional     heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic     echocardiography (TTE). Examinations were completed in accordance with previously defined     standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral     arterial disease, heart failure or cardiac vitium.   "
75999|NCT02291068|"     The Objectives of the current research is to evaluate whether psychological flexibility     influences psychotherapy outcomes in patients with adjustment disorder and depression. If     indeed this is the case, we would be able to identify risk factors for low adjustment- such     as low psychological flexibility, and develop psychotherapy that would try to enhance this     ability.   "
76000|NCT02291055|"     Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and     tolerability of the combination and to identify a RP2D.      Part B:      Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or     MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their     recurrent/persistent or metastatic cervical cancer.   "
76001|NCT02291042|"     This study evaluates the ability of a belladonna and opium suppository given prior to surgery     to improve bladder comfort after surgery for patients who are having elective ureteroscopy     surgery.   "
76002|NCT02291029|"     This study will evaluate the safety,tolerability and preliminary therapeutic efficacy of     multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary     Sjögren's syndrome(pSS)   "
76003|NCT02291016|"     The purpose of this study is to compare drug delivery and lung function after treatment with     formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from     severe exacerbations of COPD. This is to determine if one device is superior in providing     better lung function and drug deposition in this clinical setting.   "
76004|NCT02291003|"     Circadian clocks are not only found in discrete areas of the brain, but are found in     virtually every organ in our bodies, including the heart, lungs and immune system.     Disruptions in circadian clocks, or chronopathology, may underlie various forms of     cardiovascular, pulmonary, and metabolic disorders. Over the past two decades, molecular     geneticists have cracked the clock to reveal its core biochemical mechanisms evident in     organisms from fruit flies to humans. These mechanistic insights have led to the discovery of     links between clock function and an ever-expanding array of prevalent diseases, including     heart, lung, metabolic and sleep disorders. Yet the prevalence of circadian disruption in     these patient populations is unclear because current tests are not easily applied in clinical     settings or have yet to be developed. Here the investigators exploit our newfound     understanding of clock mechanisms and the development of new genomic technologies to identify     novel complements of clock-regulated genes (signatures) that will reveal the state of the     internal biological clock. This approach will allow us to take a genomic snapshot of clock     status from a single blood draw, substantially easing the diagnosis of these individuals with     evidence of circadian disruption or misalignment, i.e., chronopathology.   "
76016|NCT02290847|"     The primary objective of this study is to evaluate the effectiveness of Cognitive Processing     Therapy (cognitive only version; CPT-C) delivered using two different formats in the home     setting for the treatment of combat-related PTSD as compared to conventional face-to-face     CPT-C delivered in a mental health clinic. The study will include two different formats of     in-home therapy: face-to-face in-home CPT-C and tele-behavioral health in-home CPT-C.   "
76005|NCT02290990|"     Imaginative Distention (ID) is proposed as supportive and integrative intervention to cope     with fatigue, (principal end point), to cope with insomnia, stress perception and to improve     QoL of pw MS, insomnia pw and health care personnel. ID is safe and it can be easily learned     and practised without of any particular instrument and also feasible in disabled pw. This     technique allows persons to experience the body as a source of well-being and not just     fatigue, pain and disease. ID can become a self managed tool of empowerment to cope with MS,     to reduce its negative impact on daily life and job performances. Adherence to     pharmacological therapies could be improved using ID.      For pw MS ID could have specific and customizable rehabilitation implications to improve     motor disability, as already seen in stroke patients. The principal end point of the trial is     verify ID efficacy on fatigue and its specificity on pw MS at the end of the training. For     this reason, ID efficacy will be tested in comparative terms too. Among all possible     comparison populations, we selected: pw insomnia, which is stress related disease and health     personnel, because at risk of stress. The control groups comparison permits to evaluate the     specificity of ID on pw MS. The three groups are randomised to intervention or waiting list.     The training is 8 weekly session long. Self administered questionnaire are filled by     participants before and after the training, and 3-6 months later. The extent of change in     outcome measure monitored in each exposed group vs. unexposed will allow to separate the     non-disease specific effect of ID from the MS-specific effect. The difference in estimates     will allow to determine the extent of the true effect of ID in pw MS. All outcome measure     will be compared among all groups mentioned and over time. The study would identify also the     most important outcome measures for MS patients questioning them in a focus group. This     aspect is very important because could differs from which clinicians and researchers think     about.   "
76006|NCT02290977|"     The presence of portal vein tumor thrombosis (PVTT) in patients with hepatocellular carcinoma     (HCC) is one of the most significant prognostic factors for poor prognosis, without     treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT,     Radiation therapy (RT) showed 50% of local control and about 10 months survival duration.     Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver     Cancer Study Group (KLCSG) recommend RT as an alternative option in those patients.     Investigators previously reported the retrospective study that the scheduled interval     Trans-catheter Arterial Chemo-embolization (TACE) followed by RT for HCC combined with PVTT     and 60% of the patients showed objective response without significant elevation of     complication. However, the prospective outcomes of TACE followed by RT for HCC are scantly     reported. Based on those background, we start this prospective study to evaluate the clinical     outcomes and adverse event in the RT after TACE in the unresectable HCC patients who combined     with PVTT.   "
76007|NCT02290964|"     This study is aimed to determine if acute normovolemic hemodilution (ANH), an established     blood conservation technique, reduces the requirement for allogeneic blood transfusion in     operations with prediction of surgical bleeding over 20% of estimated blood volume (EBV)   "
76008|NCT02290951|"     This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV     (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of     REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)   "
76009|NCT02290938|"     The investigators plan to develop and test a new alcohol and other drug (AOD) intervention     for urban AI/AN youth, Motivational Interviewing and Culture for Urban Native American Youth     (MICUNAY). This intervention integrates tradition-based activities and motivational     interviewing (MI). The investigators will intervene at both the community and individual     level. At the individual level, they will provide MICUNAY to adolescents. At the community     level, they will provide discussion of AOD prevention at Community Wellness Gatherings (CWG).     This work is important because they will gain an understanding of how well a tradition-based     healing program that integrates MI works to prevent AOD use among urban AI/AN youth.   "
76010|NCT02290925|"     The investigators intend to conduct a double blind randomized clinical trial to investigate     the effect of a biscuit containing herbal extract, available in the market on the fasting     blood sugar control in patients with diabetes mellitus and also to find out whether there are     any side effects on other vital organs such as kidneys and liver.   "
76012|NCT02290899|"     The main purpose of this study is to investigate how the brain responds to a procedure known     as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a     behavioral task. Research suggest that this procedure leads to improvement in brain and     behavioral measures of inhibitory control (controlling impulses) in healthy control     participants. The investigators want to explore whether the same improvement will be seen in     kids with ADHD.   "
76013|NCT02290886|"     A multicenter phase I/II Clinical trial,randomized, controlled with placebo, triple blind to     evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal     stem cells cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis (ALS).   "
76014|NCT02290873|"     A prospective, double-blind, randomized, placebo and active controlled, multi-center,     parallel group study comparing remimazolam to placebo, with an additional open-label arm for     midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.   "
76015|NCT02290860|"     Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first     recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the     diagnostic criteria used and the population being studied.      GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus     (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM     postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance     test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S     recommendation has failed worldwide for the same reasons: the presently impractical pattern     of the testing. A solution is direly needed.      Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically,     to facilitate the recommended T2DM-pP-S in women diagnosed with GDM.      We hypothesize that, in GDM women, results of an OGTT performed after delivery, before     hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks     postpartum (OGTT-2). Our aims are:        1. To validate in Caucasian women the predictive threshold value of the 2hr-glucose of          OGTT-1 established by our Stage-1 study.        2. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the          2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2.        3. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks          postpartum).      If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum     OGTT will be avoided. Medical practice will change.   "
76019|NCT02290808|"     This study will be investigating whether a theory-based physical activity intervention can     maintain/improve moderate to vigorous intensity physical activity measured via accelerometry     of new parents over the eight months of having a child compared to a control group of new     parents.      Hypothesis: The theory-based condition will change salient underlying motives (theory of     planned behaviour constructs) for physical activity. Health-related fitness and quality of     life will also be higher for this condition in comparison to the control condition. (Note:     improvements in both groups of mothers may occur due to recovery from pregnancy, but our     hypotheses will still hold). All outcomes will remain significantly higher at eight months in     the theory-based condition compared to the standard condition   "
76020|NCT02290795|"     The vitreous fills the posterior chamber of the eye and is firmly attached, at the posterior     pole, to the macula and the optic nerve head (ONH). With formation of a stepwise posterior     vitreous detachment (PVD) exerted tractional forces could influence retinal functioning.     Especially in patients with glaucoma the influence of vitreous traction to the ONH could mask     progression, interfere with current imaging techniques and even be a cause of ONH     hemorrhages. Therefore the aim of this study is to investigate whether vitreopapillary     traction has a significant effect on diagnosis and follow up of glaucoma patients.   "
76021|NCT02290782|"     This prospective, multicentric single arm phase IV study is based on the protocol of the     international TARGIT-A and TARGIT-E study.      Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated     show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy     (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).      It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a     selected group can be non-inferior to WBRT.      The TARGIT C study should confirm the efficacy of a single dose of intraoperative     radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence     of risk factors. In presence of risk factors postoperative WBRT will be added to complete the     radiotherapeutic treatment according to international guidelines.      Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse,     cancer-specific and overall survival and contralateral breast cancer as well as documentation     of quality of life and cosmetic outcome.      The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively.     Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4%     after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and     loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a     pre-pathology stratum.      It is a pragmatic trial in which each participating centre has the option to modify entry     criteria and criteria for WBRT according to this core protocol after consultation with the     steering committee and local ethics committee (e.g. size, free margins). Only centers with     access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.   "
76022|NCT02290769|"     The aim of this study is to compare the cannulation time during primary wire guided ERCP     (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide     wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.   "
76032|NCT02290639|"     A significant number of veterans of the wars in Iraq and Afghanistan are affected by     posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD into     the veteran population is at least partially due to the perceived stigma by service members     for seeking help in traditional specialty mental health clinics. A comprehensive approach to     PTSD treatment in a veteran population should provide alternative sources for accessing     effective psychotherapy treatments. The purpose of study is to conduct a randomized clinical     trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral     therapy (CBT) protocol designed specifically for use by behavioral health consultants working     in an integrated primary care setting to a minimal contact 6-week control. The primary     outcome measure is PTSD symptom relief.   "
76023|NCT02290756|"     The investigators propose to develop and test the efficacy of a low cost evidence based     toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The     toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord     care, hypothermia management, aspiration and bag and mask techniques and APGAR score     calculation. A simple, home-based parenting program will also be implemented that will teach     parents tools that provide stimuli for brain and cognitive development in children. This     parenting program covers Early Childhood Interventions for children at risk of developmental     problems and covers developmental skill areas such as cognitive and fine motor, social and     self-help and gross motor skills. Such an intervention package provides comprehensive care to     families at the community level, with a minimal cost that can be scaled up. A new cadre of     Link workers will be implemented who will provide mentoring and supportive supervision to     Birth Attendants and will train parents in the stimulation program. The study will recruit     1080 pregnant women and their newborns.   "
76024|NCT02290743|"     The purpose of this project is to investigate the effect of Kinesio tape on muscle strength     of the quadriceps femoris in people with knee pain or symptoms and decreased muscle strength     in the quadriceps femoris - a randomized controlled trial.   "
76025|NCT02290730|"     The purpose of this project is to investigate the effect of Kinesio tape on muscle strength     of the lower trapezius in people with shoulder symptoms and decreased muscle strength in the     lower trapezius - a randomized controlled trial.   "
76026|NCT02290717|"     Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life.     Many depigmented lesions in vitiligo patients remain therapy resistant for medical treatment.     Therefore new therapeutic options in these patients are necessary. Currently, dermabrasion by     conventional or fractional laser therapy in combination with NB-UVB therapy and steroids     appears to be effective in therapy resistant areas. However, little literature on this     combination is available.      Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment in     combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB and     topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective observer     blinded randomised intra-patient controlled study.      Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB     treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical     Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are     resistant to NB- UVB treatment after 3 to 6 months.      Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be     randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser abrasion,     or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and topical     steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will be given     according to the standard treatment protocol of the SNIP and continued for at least 6 months.     Two and 6 months after the laser treatment, the percentage of repigmentation of the lesions     will be assessed.   "
76027|NCT02290704|"     Find if the retinal function is affected in both the nonsevere and the severe stage of     Graves' ophthalmopathy (GO) by comparing the retinal oxygen saturation of GO patients with     that of normal people.   "
76029|NCT02290678|"     Team building exercises have been shown to be effective in improving an individual's ability     to work within a group and build working relationships with others. Adventure Therapy     assimilates team building exercises and teachings into an adventure style excursion into the     wilderness or other non-typical environment. This combination of exposure and learning     creates a unique experience for participants which preliminary research suggests is effective     in reducing feelings of hopelessness, guilt, and shame and may increase empathy,     self-concept, self-confidence, and subjects' well-being have also been shown to be improved     by adventure therapy.      This study will use a series of questionnaires and interviews to determine whether an     adventure based therapy is both effective and reasonable as a treatment for people with mood     disorders like depression and anxiety. The objective of this study is to investigate the     efficacy of adventure based therapy as a treatment intervention for outpatients with mood     disorders. The investigators will observe any changes in mood, perceived self- efficacy,     anxiety, self-stigma, hope, quality of life enjoyment and satisfaction, leisure motivation,     and stress as a result of this intervention. As well, the investigators aim to capture     participant's opinions of the program.   "
76030|NCT02290665|"     The purpose of this study is to determine the patient preference for a biocompatible     thermosensitive solution-gel versus water or saline (liquid) enema.   "
76031|NCT02290652|"     -  Non-commercial trial        -  2 Centres involved: University Hospital Southampton and Spire Southampton        -  Expected number of eligible participants available per year: 100, (95% expected to agree          to participation)        -  The study will recruit prospectively female patients aged 18 - 65 years undergoing THR.          A retrospective series of similar patients who have had a hip replacement will also be          recruited.        -  This is a research project that will run over 2 years. Data from 200 patients will be          collected and analysed:      Retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ)     - Post-operative' Version 1.3 11/07/14      Prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) -     Pre-operative' Version 1.3 11/07/14      This project is significant in exploring an area of Orthopaedic medicine that has been little     discussed in the literature. Preliminary results of our questionnaires have already revealed     patients have a great desire to know how hip replacement will affect sexual function.     Components of the questionnaire look at details such as: reasonable time frames for returning     to sexual activity, positions that may be undesirable following replacement and which may     lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip     replacement surgery. The ultimate objective is to provide patients with detailed information     about what to expect after hip replacement surgery.   "
76033|NCT02290626|"     Study 1: A randomized, crossover trial using elemental or semi-solid diets containing     contrast medium as a tracer given to bedridden PEG patients. The distribution of the     administered diets is assessed at the distal esophagus, proximal and distal stomach using a     plain CT before and 1 hour after the administration.      Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C     sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed to     estimate gastric emptying.   "
76034|NCT02290613|"     Trial Design Patients with borderline PAH indicated by borderline mPAP values will be     included in this single centre study. This clinical investigation is performed as a     Proof-of-Concept (PoC) investigator initiated trial (IIT) using a prospective, randomized,     double-blind, parallel group, placebo-controlled, phase IIA clinical study design. On their     first visit their medical history will be obtained and physical examination will be     conducted. Moreover, an electrocardiogram (ECG), laboratory testing (NT-proBNP, uric acid and     other laboratory tests), echocardiography at rest and right heart catheterization will be     carried out. If patients have been identified within the last 6 months before screening     investigations by right heart catheterization, the measurements are considered valid as     baseline investigations and will not be repeated. If patients fulfill the inclusion criteria     and still suffer from borderline mPAP values they will be invited to join the study. The     clinical investigations will begin within 28 days. The prospective study will comprise a 6     months study period (180 ±2 weeks) plus the screening phase up to 28 days and a follow-up     phase of 30 ±7 days.   "
76035|NCT02290600|"     The purpose of this 12 week feasibility study is to see how much more accurate a continuous     glucose monitor (CGM) might be in individuals with type 1 diabetes if the investigators     personalize sensor calibrations to the user, based on previous wear.   "
76036|NCT02290587|"     In recent years, studies have brought knowledge of the difficulties of social cognition in     Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in     social cognition mechanisms remain poorly understood. Although recent behavioral studies     indicated social disturbances in many of these patients, functional studies investigating     specific theory of mind in MS are lacking. The use of new techniques for morphological and     functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping     the achievement and tissue integrity may be related to disorders of social cognition and     cognitive. The investigators propose to study social cognition in MS patients using     morphological and functional imaging to determine the mechanisms underlying phenomena such as     cerebral compensation and its relationship with cognitive impairment.   "
76212|NCT02288260|"     This NIS is a multi-centre, observational, descriptive, cross-sectional study including all     consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective,     longitudinal cohort study which will include patients hospitalized for ACS and who are with     ticagrelor on discharge from hospital.   "
76037|NCT02290574|"     The current standard treatment of locally advanced rectal cancer is neoadjuvant concurrent     chemo-radiation therapy (CCRT) followed by total mesorectal excision (TME). Recently,     laparoscopic surgery is getting substitute open surgery based on the advantages of early     recovery, short admission, less pain, less blood loss, and little scar without compromising     oncologic outcomes.      It is reported that hyperthermia is effective in synthetic (S) phase, Low oxgen pressure,     acidic, and low perfusion site which are known as radio-resistant. Because of these     characteristics, it considered as the most valuable radiosensitizer in cancer treatment,     theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor     reoxygenation.      Based on those background, the investigators start this prospective study to evaluate the     efficacy of laparoscopic TME after CCRT with hyperthermia in locally advanced rectal cancer.   "
76038|NCT02290561|"     The purpose of this study is to assess how accurately SmartTarget can direct high intensity     focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.      The current standard methods for treating prostate cancer are directed to the whole gland -     either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is     surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy     tissue.      Prior to surgery prostate cancer can often be localised using MRI imaging and detailed     prostate biopsy techniques. The difficulty is that during surgery it is very difficult to     accurately locate the cancer on the live ultrasound images - to compensate surgeons will     treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause     higher rates of side-effects.      SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the     live ultrasound during surgery. It then provides a target for the surgeons to treat during     the operation.      The results will measure if the area intended to treat was covered and if how accurate the     treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan   "
76039|NCT02290548|"     The purpose of this study is to determine whether high flow nasal cannula is effective in     lowering the reintubation rate after extubation for high risk patients in medical intensive     care unit   "
76040|NCT02290535|"     The investigator will determine a compliance of two diagnostic techniques (EIT and Body     plethysmography) in collective of children and teenagers with obstructive lung disease and a     matched control group.   "
76041|NCT02290522|"     Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA     for identification of pts who could benefit from a personalized treatment.   "
76042|NCT02290509|"     Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus     Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of     age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days     post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or     medically-attended adverse events.   "
76044|NCT02290470|"     This randomized, pilot study explores the activity of olanzapine with or without delayed     dexamethasone for the prevention of delayed nausea and vomiting in women with gynecologic     cancer receiving the combination of carboplatin and paclitaxel. Women treated with this     regimen are particularly susceptible to chemotherapy-induced nausea and vomiting. Given     anti-emetic prophylaxis with olanzapine may increase the control of delayed symptoms in women     receiving carboplatin and paclitaxel.   "
76087|NCT02289911|"     Training paramedics in new skills via classroom-based teaching has inherent costs and time     constraints. The investigators sought to evaluate whether web-based didactics result in     similar knowledge improvement and retention of FAST (Focused Assessment with Sonography for     Trauma) compared with the traditional method.   "
76231|NCT02288013|"     Comparative study of the surgical outcome of 2-layers closure technique of uterine incision     in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture     material (Vicryl) regarding the time of closure and the need of secondary additional suturing     or tearing of uterine muscles during suturing.   "
76045|NCT02290457|"     Background: It has been demonstrated that core strength training is an effective means to     enhance trunk muscle strength (TMS) and athletic performance in youth. However, the role of     instability with core strength training is unresolved in youth. This study specifically will     investigate the effects of core stability (CST) compared to core instability strength     training (CIST) on physical fitness in adolescents.      Methods: Twenty-seven (14 girls, 13 boys) healthy adolescents (age 14±1 years) will be     assigned to a CST (n=13) or a CIST (n=14) group. Both training programs will last 6 weeks (2     sessions/week) and included frontal, dorsal, and lateral core exercises. During CIST, these     exercises will be conducted on unstable surfaces (e.g., TOGU© DYNAIR CUSSIONS, THERA-BAND©     STABILITY TRAINER).      Expected Results: Based on selected results reported in the literature, we hypothesize that     participants performing CIST as compared to CST will show larger improvements in physical     fitness tests (i.e., strength, speed, flexibility, coordination, balance) following training.     Of note, training induced gains in strength, speed, flexibility, coordination, and balance     are of vital importance for sports performance, everyday activities, and injury prevention.   "
76046|NCT02290444|"     The purpose of this study is to evaluate the effect of a medication called Acthar on recovery     from multiple sclerosis-related relapses that impact cognition.   "
76047|NCT02290431|"     The purpose of this study is to evaluate the efficacy and safety of panobinostat in     combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory     multiple myeloma.   "
76048|NCT02290418|"     The aim of this study is to compare the relative clinical outcomes between two variants of     gastric bypass [Roux-en-Y Gastric Bypass (RYGB) or Omega-Loop Gastric Bypass (OLGB)] in     metabolic surgery candidates with Body Mass Index (BMI) between 35 and 50. The study will     examine the short and medium term effects of each intervention on weight, obesity     comorbidities, quality of life and gastroscopy findings.   "
76049|NCT02290405|"     The purpose of this study is to learn more about people with insomnia disorder and cognitive     impairment. Cognitive impairment is difficulty with mental abilities such as thinking,     knowing and remembering.   "
76059|NCT02290275|"     The goal of this research project is to determine the effectiveness of creatine     supplementation and supported low-load walking exercise for managing systemic inflammatory     biomarkers and joint symptoms in individuals diagnosed with chronic symptomatic knee     osteoarthritis. The central hypothesis of this investigation is that creatine supplementation     and exercise will significantly lower systemic biomarkers of inflammation in patients     diagnosed with knee osteoarthritis.   "
76050|NCT02290392|"     Background:      - High blood pressure is a common problem. It can cause heart attacks, strokes, and kidney     failure. It affects African Americans more than other racial groups. Data were collected from     over a thousand African Americans across the country. The data were put into a database     (MH-GRID). The data were about genes, diet, sleep, body mass index. They also cover stress     and access to healthy foods and parks. Researchers at NIH will study these data in new ways.     They want to learn more about the connection between African Americans and high blood     pressure.      Objective:      - To study MH-GRID data to find the causes of severe high blood pressure and other     cardio-metabolic problems in people of African ancestry.      Eligibility:      - African Americans age 30 55 with severe high blood pressure were used in the MH-GRID study.     No new participants will be enrolled in this study.      Design:      - Researchers will examine data from the MH-GRID study.   "
76051|NCT02290379|"     Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety     and tolerability study of TNX-201 capsules in healthy volunteers.   "
76052|NCT02290366|"     The standard options for men with very low risk prostate cancer include active surveillance     and the standard treatment options for low risk disease, i.e. radical prostatectomy, external     beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to     evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk     prostate cancer. The goals of the study are to determine the biochemical disease free     survival at five years in these patients, as well as to determine the acute and late urinary,     bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131.     Patients eligible for the study will be men with histologically confirmed adenocarcinoma of     the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific     antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum     of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI.     The study is a phase II study. Patients will be followed prospectively. Dosimetry will be     evaluated post-procedure, and PSAs will be obtained every three months in year one and every     six months from year two through year five. Urinary, bowel, and sexual morbidity will be     assessed by patient survey prior to treatment , two weeks, after treatment, at three month     intervals in year one and at six month intervals in years two through five.   "
76053|NCT02290353|"     The investigators have assembled an integrated knowledge/technology/client team to develop a     novel motion capture-based home therapy program for children with hemiparesis (cerebral     palsy, acquired brain injury (ABI)) and older persons post-stroke. The investigators society     needs new approaches to improve the quality of life for millions of Canadians. The method     proposaed here is to combine low-cost motion capture devices, a bimanual training program,     social media frameworks such as Facebook Games, and on-line performance sharing between     therapy clients and with their therapists. The investigators believe that together these     approaches will yield interventions for people with stroke and children with hemiplegia that     significantly improve their motivation to continue their exercise programs and thus improve     their functional ability which will lead to improved quality of life.   "
76054|NCT02290340|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an     extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to     placebo when administered to healthy preterm infants.   "
76055|NCT02290327|"     The purpose of the this Pilot Trial is to determine the feasibility of conducting a large     randomized controlled trial (RCT), that aims to examine the efficacy and safety of using     pantoprazole compared to placebo for stress ulcer prophylaxis in critically ill mechanically     ventilated patients in the ICU.   "
86010|NCT02160210|"     This study is the evaluation of ultrafine endoscope (with small caliber and turning radius     )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in     this trial.   "
76056|NCT02290314|"     Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on     an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting     nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason     for spine surgery particularly in individuals over age 65 years. Recently novel minimally     invasive surgical techniques have heightened public and government interest by touting     benefits of reduced approached-related morbidity which in turn leads to quicker recovery,     shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost.     However, there is no randomized controlled trial evidence to describe the actual advantages     and disadvantages associated with minimally invasive spinal fusion. This pilot study is a     randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to     traditional open posterior lumbar interbody fusion (PLIF) with respect to length of stay,     approach related morbidity, patient centered outcome measures, and cost-effectiveness in the     treatment of degenerative lumbar spondylolisthesis.   "
76057|NCT02290301|"     The primary objective of the study is to investigate cardiovascular safety of gemigliptin by     evaluating the time until patients report with major adverse cardiovascular events (MACE) in     T2DM patients treated with gemigliptin.      Study patients will be followed up to 4 years until MACE occurrence or until the patient     drops out of the study or completion of the study. The patient who switches to a     non-gemigliptin treatment after initiating gemigliptin therapy will be followed until MACE     occurrence or until the patient drops out of the study or completion of the study.      The secondary objectives of the study are to evaluate adverse events related as well as     not-related to MACE in diabetic patients treated with gemigliptin.   "
76058|NCT02290288|"     The study is carried out at the Sahlgrenska University Hospital and the patient population     consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault     prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either     vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of     the types of surgery. The primary outcome is anatomical failure based on clinical assessment.     Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system,     as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the     surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse     symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.   "
76112|NCT02289586|"     To evaluate the effect and safety of noninvasive ventilation assisted interventional     bronchoscopy for hypoxemia patients with central airway stenosis.      With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy     for hypoxemia patients with central airway stenosis is safe and effective, carries high     satisfaction rate.   "
76060|NCT02290262|"     Background: Patients undergoing coronary artery bypass graft surgery often experience a range     of problems and symptoms related to the procedure and the underlying heart disease.These     problems include anxiety and depressive symptoms, immobility issues, complications such as     wound seeping, neck and shoulder pains, interrupted and insufficient sleep. No studies have     tested a combined intervention on phase 1 rehabilitation in coronary artery bypass graft     surgery patients. However, randomised trials with either a physical or a mental part have     been conducted with positive result, but evidence is lacking for a combined intervention.     Before a large randomised trial was set up a pilot trial was conducted to evaluate the     feasibility of patient recruitment and intervention: to test the safety and tolerability of     the intervention by patients and to provide outcome data for sample size calculations. The     SheppHeartCABG pilot showed trial feasibility, safety and sufficient inclusion rate and high     compliance with most elements. Outcome data from the pilot trial has been used to sample size     and power calculation in this randomised clinical trial.      Objective: The objective of this trial is to investigate the benefits and harms of a phase 1     comprehensive cardiac rehabilitation programme consisting of an exercise-training and a     psycho-educative component, including plus treatment as usual in patients who undergo     coronary artery bypass grafting.   "
76061|NCT02290249|"     Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to     improve teaching intubation. The investigators want to find their efficacy in normal airway,     tongue edema and face-to-face orotracheal intubation models by novice personal.      Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six     medical students who were on the beginning of their third year were enrolled in this study.     After watching a video about the intubation of one of these devices, they attempted to     intubate an adult manikin in three different airway models in a random order; first in normal     airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach     with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success     rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.   "
76062|NCT02290236|"     The overall aim with this project is to describe the correlation between measured and charted     saturation after intensive care and also describe the saturation-pattern in these patients.     The investigators will also correlate post-ICU desaturations measured as oxygen denaturation     index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening     questionnaire.   "
76063|NCT02290223|"     Will a primary care-based behavioral intervention for patient activation and engagement and     self-management, for patients with chronic pain who are taking opioid pain medication, result     in better patient outcomes than Usual Care?   "
76064|NCT02290210|"     The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in     gout patients with hyperuricemia   "
76088|NCT02289898|"     This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic     pancreatic ductal adenocarcinoma.      The purpose is to test the efficacy and safety of demcizumab, when given in combination with     gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and     Abraxane® is a standard treatment for patients with metastatic pancreatic ductal     adenocarcinoma.   "
76089|NCT02289885|"     The study evaluates the knowledge, attitude and practice about Focused Assessment with     Sonography in Trauma among emergency medicine practitioners in Poland.   "
76090|NCT02289872|"     The aim of the study was to compare time and success rates of TruView PCD video laryngoscope     and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios     in a standardized manikin model.   "
76065|NCT02290197|"     Knee dislocation is a serious injury, usually caused by high-energy trauma. It is classically     defined as complete loss of articular congruence between the femur and the tibia, confirmed     by radiography. However it is common that the reduction happens spontaneously. For this     reason, today the investigators also consider a patient suffered knee dislocation in the     presence of multi-ligament injury involving the posterior cruciate ligament, often in     association with anterior cruciate ligament, lateral and/or medial ligamentous complex.      It is considered a serious injury, because both the strong association with vascular and     nerve damage, which can lead to the need for limb amputation, such as the difficulty in     obtaining a good functional outcome even after treatment of all ligament injuries.      The treatment of these injuries aims to achieve knee stability. Joint mobility is often     sacrificed in the postoperative period, with the use of immobilizations such as casts,     splints or bracing. Unfavorable clinical outcomes with high rates of stiffness and joint pain     are very common in these patients. In attempts to improve these results, rehabilitation     protocols with early range of motion can be employed. However, results may remain     unsatisfactory, predominantly because of knee instability recurrence.      Stannard and Zaffagnini proposed a new model for treatment of acute knee dislocations. In     this model, after multi-ligament reconstruction or repair, a knee articulated external     fixator is used. Such external fixator allows early and aggressive joint mobility in the     sagittal plane only. Flexion and extension are permitted, but rotational movements,     translations in the anterior-posterior plane, lateral (varus) and medial (valgus) openings     are not allowed. Thus protective stability is ensured for ligament reconstruction procedures.     Simultaneously the investigators allow immediate joint mobilization, reducing the risk of     arthrofibrosis, joint stiffness and postoperative ligament laxity.      There is no consensus regarding the use of hinged external fixator postoperatively in     multiple ligament reconstruction procedures for treatment of knee dislocations.      The objective of this study is comparing functional outcomes after ligament reconstruction in     patients with knee dislocation, with or without the use of hinged external fixator.   "
76066|NCT02290184|"     This is a pilot randomized controlled trial intervention to improve lifestyle behaviors     (physical activity and health diet) for Filipino Americans with type 2 diabetes on metformin.     If the PilAm Go4Health intervention demonstrates potential efficacy, it may identify     effective intervention strategies to significantly reduce risks for heart disease risks     (i.e., metabolic syndrome) in Filipino Americans.   "
76067|NCT02290171|"     The overall aim is to evaluate if a familybased intervention, targeting overweight and obese     children and their parents, has a long-term positive effect on weight development and health     of the children. The alternative hypothesis to the zero hypothesis is that the children with     overweight and obesity who participate in a one-year intervention together with their     parents, both at completion of the six months intervention and at long term follow up will     have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The     behavioral models and educational strategies will be tailored (by age, gender etc.) and     include both general information and practical learning sessions.   "
76068|NCT02290158|"     This study evaluates the effects of a finishing protocol in orthodontic outcomes using     ABO-OGS scores. Patients who finish orthodontic treatment and fulfill the inclusion and     exclusion criteria receive a treatment using a finishing protocol and their scores are     compare with 40 patients who don't receive a finishing protocol   "
76069|NCT02290145|"     The purpose of this study is to To confirm the predictive value of CCD1 for TPF induction in     cN2 patients with OSCC   "
76070|NCT02290132|"     The clinical application and effect of ATG based myeloablative conditioning regimen after     allogeneic hematopoietic stem cell transplantation in adult patients with aggressive T-cell     lymphomas.   "
76071|NCT02290119|"     The primary objectives of this study are to understand the effects of soft-tissue balancing     on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty     and correlate Intra-operative subjective feel with OrthoSensor Outputs      Secondary objectives are to quantify and observe:        -  Pain medication use        -  Swelling        -  Muscle strength and girth        -  Gait efficiency        -  Patient satisfaction        -  Activity levels, functional return (i.e., back to work, resume normal activities)        -  Patient perception of a balanced knee   "
76072|NCT02290106|"     HMG co-A reductase inhibitors, commonly called statins, are an effective treatment for     dyslipidemia and atherosclerotic heart disease with proven mortality benefit. While the     lipid-lowering effects of statins are well-known, other metabolic effects, including effects     on glucose tolerance and ectopic fat distribution, are less completely understood. Recent     studies have shown that some statins may increase the risk of diabetes. Further, research has     suggested that statins may have some benefit in nonalcoholic fatty liver disease (NAFLD), a     condition associated with obesity that includes increased fat in the liver (steatosis) and,     in some cases, inflammation and hepatocellular damage (steatohepatitis). Pitavastatin,     approved by the United States Food and Drug Administration (FDA) in 2009, is the most recent     statin to enter the market. Unlike most statins, pitavastatin is not primarily metabolized     through cytochrome P450 (CYP450), and thus has reduced potential for interactions with other     medications that are metabolized by CYP450. Previous studies have suggested that pitavastatin     may be neutral to glucose homeostasis and may improve hepatic lipid. Neither of these effects     has been proven definitively, however, and the current proposal aims to characterize in     detail the effects of pitavastatin on glucose homeostasis, hepatic steatosis, and     steatohepatitis.   "
76073|NCT02290093|"     The success of colonoscopy is closely related to the quality of colonic preparation. However,     data regarding colonoscopy preparations in the elderly (65 years older) are scarce.     Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence     is lacking in this particular group of patients. Moreover, patient tolerability is a key     factor for success of bowel preparation in the aged people.      The purpose of this study is to compare the bowel cleansing efficacy and patient compliance     of following bowel preparation methods prior to elective outpatient colonoscopy in the     elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before     colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume     [2L] PEG-3350 containing ascorbic acid solution.   "
76091|NCT02289859|"     The purpose of this study is to determine whether undermining during cutaneous surgery     improves scar cosmesis compared to wound closure without undermining.   "
76092|NCT02289846|"     The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic     gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.   "
76093|NCT02289833|"     This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of     trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2     IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with     trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram     (mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the     investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs     first.   "
76074|NCT02290080|"     Oxygen treatment is widely used in acutely ill patients, both pre-hospital and in hospital.     The indication for oxygen is sometimes unquestionable, such as in many hypoxic patients, but     in other situations its use is more of a practise and much less based on scientific evidence.     In particular, oxygen treatment is routinely used in patients with a suspected heart attack     and variably recommended in guidelines, despite very limited data supporting a beneficial     effect. Indeed, a few studies even indicate that oxygen treatment might be harmful.      Immediate re-opening of the acutely blocked artery to the heart muscle is the treatment of     choice to limit permanent injury. However, the sudden re-initiation of blood flow achieved     with primary percutaneous coronary intervention (PCI), the reopening and stenting of the     blocked vessel, can give rise to further endothelial and myocardial damage, so-called     reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury)     involves a wide range of pathological processes. Vascular leakage, activation of cell death     programs, thrombocytes and white blood cells leading to extended inflammation and formation     of clots are examples of those effects.      The role of oxygen treatment on these pathological processes, on the extent of IR-injury and     the final infarct size in patients with acute myocardial infarctions (AMI) has not previously     been studied.      In an ongoing national multicentre, randomized, registry based clinical trial, the DETO2X-AMI     trial (NCT01787110), the effect of oxygen on morbidity and mortality in ACS patients is being     investigated.      The present DETO2X-biomarkers study is a substudy of the DETO2X-AMI trial, evaluating the     effect of oxygen treatment on biological systems involved in the pathogenesis of reversible     and irreversible myocardial damage and cell death in ACS.   "
76075|NCT02290067|"     The aim of this test is to determine the system accuracy and user performance evaluation of     three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data     should cover the whole range of glucose concentration which could usually be expected in     patients with diabetes mellitus.   "
76076|NCT02290054|"     Urinary retention is a common complication of epidural analgesia. Auriculotherapy could     prevent this complication. This study will be performed among men receiving thoracic epidural     analgesia after thoracic surgery.   "
76077|NCT02290041|"     Clinical trial phase I/II, of test of concept, blind double, and controlled with placebo,     randomized 2:1 (Treatment: placebo), in which a total of 15 patients will be included   "
76078|NCT02290028|"     The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP     left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in     the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.      Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed     during the ongoing post approval phase (US sites only).   "
76079|NCT02290015|"     This trial was a randomized, single-blinded, sham-controlled study, in which the patients     were blinded to treatment assignment. First, all candidates underwent audiological testing of     hearing thresholds, tympanometry and stapedius reflex tests. The patients who were selected     for the study were interviewed to assess and evaluate their condition and then underwent a     detailed physical examination that included a complete otorhinolaryngologic examination and a     complete blood test. Then, the subjects were randomized to undergo true or sham ACP. Seven     days before (baseline) and seven days after twelve acupuncture (ACP) sessions (up to six     weeks), which were performed twice a week, all participants underwent 99mTc-ECD SPECT     scanning and completed the Portuguese version of the Tinnitus Handicap Inventory (THI), the     Visual Analogue Scale (VAS), Hamilton Anxiety Scale (HAS) and the Beck Depression Inventory     (BDI). The purpose of this study was to integrate the neuroscience research findings with the     clinical research on tinnitus. Thus, a randomized, single-blinded, placebo-controlled trial     was implemented to investigate the effect of ACP as a treatment for tinnitus using     ethylcysteine dimer single-photon emission computer tomography (99mTc-ECD SPECT).   "
76080|NCT02290002|"     The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing     in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent     intracytoplasmic sperm injection (ICSI).   "
76081|NCT02289989|"     This study is designed to evaluate and compare the efficacy of 3% oregano extract ointment     prepared in aqueous solution versus 1% hydrocortisone ointment, a standard treatment, in     decreasing the inflammation associated with mild to moderate atopic dermatitis. We plan to     recruit 40 patients on the ages comprised between 2 and 17 years old and the study duration     for each of the patient is 1 month.   "
76082|NCT02289976|"     The purpose of this study is to determine if surgical angiogenesis performed in talar     avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a     superior technique compared to core decompression and nonvascularized osseous autografts.   "
76135|NCT02289274|"     The purpose of this study is to compare the pharmacokinetics of NVP-1203 and coadministration     of aceclofenac and eperisone HCl SR.   "
76083|NCT02289963|"     Primary Objective:      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as     add-on therapy to stable maximally tolerated daily statin therapy with or without other     lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high     cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.      Secondary Objectives:        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks          of treatment.        -  To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo          B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC),          lipoprotein (a) (Lp [a]), high-density lipoprotein cholesterol (HDL-C), triglycerides          (TGs), and apolipoprotein A-1 (Apo A-1).        -  To evaluate the safety and tolerability of alirocumab.        -  To evaluate the development of anti-alirocumab antibodies (ADA).   "
76084|NCT02289950|"     MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to     assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in     subjects with low CA125 platinum sensitive ovarian cancer in first relapse.   "
76085|NCT02289937|"     The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous     femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery.     The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the     postoperative pain without delaying mobilization.   "
76086|NCT02289924|"     The main objectives of this non-interventional cohort field study are to evaluate     effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients     with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a     study population of naïve patients   "
76130|NCT02289339|"     The purpose of this registry is to document the everyday practice in our centers with minimal     invasive treatment of patients with aortic valve disease who were considered suitable for     transfemoral aortic valve implantation by heart team.   "
76094|NCT02289820|"     The goal of this study is to evaluate the safety, tolerability and immunogenicity of     ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60     years or older who are healthy or who have stable, chronic underlying medical conditions.     This study will also provide preliminary safety and immunogenicity data to support concurrent     dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a     dose previously assessed in the Phase 1a study.   "
76095|NCT02289807|"     Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard     treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National     Comprehensive Cancer Network guideline. However these recommendations were based on the     evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of     intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better     treatment outcomes than 2DCRT. It has been questioned whether additional concurrent     chemotherapy is still necessary for intermediate risk NPC within the excellent framework of     IMRT. hus, we jointly conduct the first non-inferior randomized trial to determine the value     of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with     IMRT. Given the results of clinical studies mentioned above, we decide to adopt the     concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43   "
76096|NCT02289794|"     This Phase I multi-center placebo controlled study is conducted in healthy women with a     history of recurrent urinary tract infections (UTI) aged between 18 and 70 years.   "
76097|NCT02289781|"     A randomized, controlled clinical trial is designed to analyze the wear of enamel by opposing     polished monolithic zirconia crowns and by the polished veneer surfaces of metal-ceramic     crowns. This single-blind pilot study will involve a total of 30 teeth that require full     coverage crowns that oppose natural antagonist teeth.      The objectives of this research are to test the following hypotheses: (1) differences between     mean wear of antagonist enamel by polished monolithic zirconia crowns and by the polished     veneer surface of metal-ceramic crowns are statistically significant; (2) differences between     mean wear of antagonist enamel by opposing polished monolithic zirconia crowns and enamel by     opposing enamel are statistically significant; and (3) differences between mean antagonist     wear of enamel by opposing polished veneer surfaces of metal-ceramic crowns and enamel by     opposing enamel are statistically significant.   "
76136|NCT02289261|"     The purpose of this study is to determine whether dexmedetomidine added to morphine is     effective in the treatment of chronic cancer pain.   "
76098|NCT02289768|"     The main purpose of this vehicle-controlled study is to determine the efficacy and safety of     a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the     field-directed treatment of grade I-II actinic keratosis, when it is applied to the affected     area once daily for 12 weeks.      A secondary objective of this study is to evaluate the efficacy of Actikerall® solution on     subclinical actinic keratosis lesions in a subset of patients.   "
76099|NCT02289755|"     The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate     excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.   "
76100|NCT02289742|"     The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES®     Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua     Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.   "
76101|NCT02289729|"     Patient reported outcomes (PRO) have become an important endpoint assessed in clinical     trials. It is important to understand the relationship between medication and patients'     symptomatology, quality of life and wellbeing. We predict Duodopa will significantly improve     quality of life and emotional wellbeing compared to baseline in patients with advance     Parkinson disease (APD) not well controlled with conventional treatment.   "
76102|NCT02289716|"     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of     fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of     osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.   "
76103|NCT02289703|"     The purpose of this study is to assess the pharmacokinetics (the study of the way a drug     enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may     change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy     participants with a creatinine clearance (CLcr) greater than equal to (>=) 80 milliliter per     minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on     maintenance hemodialysis (a method used to remove waste material from the blood when the     kidneys are unable to do so).   "
76104|NCT02289690|"     The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin     and etoposide in participants with extensive disease small cell lung cancer (ED SCLC). ED     SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin,     with or without the involvement of regional lymph nodes, including ipsilateral and     contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral     supraclavicular nodes   "
76105|NCT02289677|"     We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric     manikins while performing CPR. In the current study, we compared effectiveness of two     video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible     Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation with     uninterrupted chest compressions using an child manikin.   "
76106|NCT02289664|"     We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric     manikins while performing CPR. In the current study, we compared effectiveness of three     video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and     without chest compressions using an child manikin.   "
76107|NCT02289651|"     We hypothesized that the Venner videolaryngoscope (A.P. Advance™) is beneficial for     intubation of pediatric manikins while performing CPR. In the current study, we compared     effectiveness of the Venner videolaryngoscope (A.P. Advance™) and MIL laryngoscopes in child     resuscitation with and without CC.   "
76108|NCT02289638|"     We hypothesized that the Intubrite Video Laryngoscope System VLS 6600 is beneficial for     intubation of pediatric manikins while performing CPR. In the current study, we compared     effectiveness of the Intubrite and MIL laryngoscopes in child resuscitation with and without     CC.   "
76109|NCT02289625|"     Abstract      Obstructive sleep apnea syndrome (OSA) is characterized by complete or partial collapse of a     narrowed pharynx and it's associated with reduction in cerebral blood flow, cardiovascular     disease, and neuropsychological deficits and reduces survival. In patients with AOS     structural, metabolic and hypoperfusion cerebral were associated not only with physiological     functions but also with attention and executive function. There is a higher association     between apnea hypopnea index and Mini-Mental State Examination in individuals with the exon 4     of APO E gene, indicating that exon 4 of APO E gene confers an increased risk for cognitive     decline in individuals with sleep apnea. The analysis of presence and consequences of OSA in     cerebral structure, inflammation and neurovascular control can permit a better investigation     of abnormalities in these individuals and implement interventions to reduce the risk of     development of cognitive and cardiovascular impairment. The non-pharmacological intervention     through exercise training can represent an important strategy for improvement in cerebral     alterations, cognition and reduction in sleep apnea index. The purpose of present study is     investigate the volume and metabolism cerebral, neurovascular control, cognition and exon 4     of APO E gene and their   "
76110|NCT02289612|"     The purpose of this study is to determine the specific properties of a variety of dietary     fibres that lead to different postprandial glycemic and satiety responses in individuals at     risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that     demonstrate a wide range of properties in a pudding product, and by examining the ability of     each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion,     and improve satiety, versus a low fibre control product.   "
76111|NCT02289599|"     This study will be a single-center, single dose, randomized, double-blind, placebo-controlled     study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young     subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be     treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be     determined in Part A. Part B will be initiated after Part A is completed. In Part B one     cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose     level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts     sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg,     200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6     subjects to a single dose of E2307 and 2 subjects to placebo.   "
76113|NCT02289573|"     Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute     exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating     phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very     important therapy for those patients,but traditional ventilation modes have some defects, so     investigators need to find new modes to solve these problems. In this study, the     investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the     effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more     appropriate ventilation mode for AECOPD patients.   "
76114|NCT02289560|"     The objective of this prospective, multi site, single-arm study is to capture the efficacy of     treatment using the ExAblate Transcranial System and to further demonstrate safety in     medication-refractory tremor in patients with essential tremor (ET).   "
76115|NCT02289547|"     XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with     advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for     combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative,     dose-related toxicity. It may therefore be possible to devise capecitabine maintenance     regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We     study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by     maintenance Capecitabine or Observation in the gastric cancer patients of stable disease     after 6 cycle 1st line of XELOX chemotherapy .   "
76116|NCT02289521|"     This study aims to evaluate the effect of stimulation of prefrontal regions on language     performance (e.g. word translation and picture naming).      During the language tests, cortical activity will be registered using electroencephalography     (EEG) which will provide supplementary information about the cerebral processus involved in     language production and management of two languages in bilingual subjects.   "
76117|NCT02289508|"     Objective:      The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for     measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this     study are:        1. To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output          (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a          compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome          (adHFS)        2. To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and          DO2 correlate with heart failure staging, especially New York Heart Association (NYHA)          class and American Heart Association (AHA) stage.        3. To investigate whether USCOM-derived haemodynamic parameters such as velocity time          interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2          correlate with ejection fraction.        4. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic          indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).        5. To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic          Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards          as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of          haemodynamically stable and unstable adult patients.      Design:      This prospective observational cohort study will be conducted in the Prince of Wales Hospital     in Hong Kong.      Setting and Subjects:      Patients will be screened and recruited from adult patients either scheduled for elective     2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency     department at the Prince of Wales Hospital.      Interventions:      Haemodynamic measurements made using the USCOM and 2D-echo will be compared. In order to     assess inter-observer variability, a second, blinded operator will repeated 15% of scans.   "
76151|NCT02289066|"     This study examines how periodontal disease affects the complications of diabetes and how     treatment for periodontal disease affects biomarkers associated with the complications of     diabetes.   "
76152|NCT02289053|"     Conflicting guideline recommendations for screening colonoscopy result due to scant data upon     which to develop appropriate recommendations. No previous study has compared the prevalence     of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first     degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk     individuals with no family history of CRC. The purpose of this study is to determine the     prevalence of colon adenomas in 40-49 year old individuals and identify risk factors     associated with the presence of advanced adenomas. This data will provide evidence to     determine appropriate colon cancer screening guidelines in 40-49 year old persons with a     family history of colon polyps or colorectal cancer.   "
76118|NCT02289495|"     The proposed study, 200207 is a double blind, placebo controlled, single and repeat dose     escalation study to investigate the safety, tolerability and PK of GSK2838232 alone and when     co-administered with RTV 100 milligram (mg) Once daily (QD). This study will enable future     clinical development of GSK2838232 in healthy subjects and in a Phase IIa proof of concept     study in Human Immunodeficiency Virus (HIV) infected patients. This study is a single and     repeat dose escalation study and will be conducted as two Parts. Part A will evaluate     GSK2838232 20 mg and 50 mg administered QD for 8 days and Part B will evaluate GSK2838232 10     mg, 20 mg, and 50 mg, co-administered with RTV 100 mg, QD for 11 days. The extended period of     dosing is to account for the longer terminal phase half-life of GSK2838232 when given with     RTV. Dose cohorts will be enrolled sequentially; enrollment into a cohort will commence     following review of interim PK and safety data from at least 4 subjects in the preceding     cohort. Subjects in both parts will have a screening visit within 30 days prior to first dose     and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation     will be approximately 7 weeks. Approximately 40 healthy subjects will be enrolled, 8     subjects/cohort. Subjects will be randomized 3:1 to receive GSK2838232 or placebo.   "
76119|NCT02289482|"     This study investigates the safety, tolerability and PKs of GSK2838232 with and without     Ritonavir, and to evaluate different formulations of GSK2838232 in healthy subjects. This     study will evaluate higher single and RTV boosted doses to support continued clinical     development of GSK2838232 at clinically relevant doses, and subsequently in those infected     with HIV in a dose ranging phase 2 study. The study is conducted in 2 parts: Part A and Part     B, study Part A and Part B may be conducted in parallel. Approximately 20 healthy subjects     will be enrolled into the study, 8 in Part A and 12 in Part B. Part A is a double-blind,     randomized, placebo-controlled, 4-period, single dose escalation design. Subjects will be     randomized 3:1 to receive GSK2838232 or placebo. Subjects randomized to placebo will receive     placebo in all four periods. Following completion of Period 2 PK assessments at 96hr     post-dose, subjects will begin daily dosing of RTV 100mg for a total of 26 days.      Part B is a randomized, open-label, unbalanced, 3-period, cross-over design; subjects will be     randomized 1:1 to each sequence. The relative bioavailability of single 100mg doses of powder     in a bottle (PIB) active pharmaceutical ingredient (API) of GSK2838232 versus PIB spray-dried     dispersion (SDD) will be assessed. A single dose of GSK2838232 will co-administered on the     10th day of RTV dosing; RTV dosing will continue for an additional 4 days (total of 14 days).     Subjects will have a screening visit within 30 days prior to first dose and a follow-up visit     7-14 days after the last dose.   "
76137|NCT02289248|"     Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV     infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks.   "
76138|NCT02289235|"     The investigators want to evaluate the effects and safety of ginger in treatment of     nonalcoholic fatty liver disease (NAFLD).   "
76139|NCT02289222|"     This is an open label trial of Anti PD1/MD-3475, Pomalidomide and dexamethasone. The study     will use standard (FDA approved) doses for both pomalidomide and dexamethasone. The     experimental drug Anti PD-1 (MK 3475) given on days 1 and 14.   "
76140|NCT02289209|"     Eligible participants with locoregional inoperable recurrence or second primary squamous cell     carcinoma of the head and neck will be treated with reirradiation combined with anti-PD-1 mAb     MK-3475 (generic name: pembrolizumab, trade name Keytruda®).   "
76120|NCT02289469|"     Medication safety is an important concern in hospital Emergency Departments (EDs), which     provide approximately 136 million patient visits annually in the US. An accurate list of the     patient's medications is often needed to inform medical decision-making. Moreover, health     care facilities are required to provide patients with an accurate, reconciled list of their     medications upon completion of the visit. However, for 37-87% of patients in the ED, errors     are present in the documented medication list, and patients often leave without an updated     list of their medications or a good understanding of their self-care instructions. This     increases the risk of harmful adverse drug events. Health disparity populations, who are more     likely to seek care in EDs and who more often have difficulty providing a complete medication     history, are disproportionately affected.      Health information technology has the potential to improve medication safety in this setting.     PictureRx is an internet-based platform designed to improve medication management in     vulnerable populations. It allows users to generate illustrated medication lists in an     easily-understood, patient-centered format, in either English or Spanish. The investigators     have developed a process for importing prescription fill data from the Surescripts Medication     History service, which covers 96% of US pharmacies, into the PictureRx platform. The     investigators are developing a mobile tablet PC-based medication history platform that     receives and processes the Surescripts data, as well as prompts verification and additional     information about the medication regimen.      This trial will assess the effect of the PictureRx medication history platform on the     accuracy and efficiency of the medication reconciliation process, as well as patient     understanding and satisfaction, in hospital Emergency Departments.   "
76121|NCT02289456|"     4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by     nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4     cycles.   "
76122|NCT02289443|"     In this study, the investigators propose a 10-year follow up study of participants in a     randomized clinical trial to compare the oral health-related quality of life (OHRQoL), as     well as general and related satisfaction of conventional complete dentures fabricated using     two different procedures.   "
76123|NCT02289430|"     The purpose of this study is to compare the drug interaction of pharmacokinetics of     rosuvastatin and ezetimibe.   "
76125|NCT02289404|"     The purpose of this study is to Evaluate food effect of NVP-1203 in healthy Korean male     adults.   "
76126|NCT02289391|"     The study try to illustrate the possible mechanisms of tending to induce airway spasms and     the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with     asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5,     IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and     non-asthma patients.   "
76127|NCT02289378|"     This is an open-label, phase II study to evaluate the efficacy and safety of biweekly     docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the     first-line therapy.   "
76128|NCT02289365|"     This trial is designed as a multicenter, double-blinded, randomized, placebo controlled study     to assess the safety and efficacy of JBM-TC4 for the prevention and treatment of acute     radiation-induced dermatitis in breast cancer patients receiving radiotherapy.   "
76129|NCT02289352|"     A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to     Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson     Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33%     (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema     Associated with Rosacea   "
76131|NCT02289326|"     Purpose      This study is an 'N-of-one' observational study focusing on individuals with a hereditary     predisposition to cancer due to a genetic mutation in the TP53 gene. An individual with this     mutation has a >90% chance of developing many different forms of cancer in their lifetime.     Since germline TP53 gene mutation carriers are highly susceptible to cancer, cancer     prevention strategies and early cancer detection strategies are crucial. Unfortunately, the     current standard of care for monitoring germline TP53 gene mutation carriers for early signs     of cancer is yearly MRI scans and intermittent blood draws. Villani et al. showed that     standard monitoring is inadequate and introduced a more sophisticated protocol for early     cancer detection. We extended the Villani et al. protocol to include a number of markers for     early detection and are currently vetting their utility, in terms of their inherent     variability, patient tolerability of frequent interrogation, and ability to show changes that     might indicate a need for further examination.      In addition to the markers being collected, important covariate information, such as diet,     sleep, and activities are being collected (via, e.g., wearable wireless devices) in order to     take them into account in assessing the levels of the markers at a single data collection     time or over time. One important aspect of the protocol is to identify changes, rather than     specific levels, in marker status over time for an individual that might be indicative of     tumor formation, essentially exploiting the concept of 'personalized thresholds' discussed by     Drescher et al.      If any indication of the presence of a cancer, tumorigenic process, or general sign of     ill-health is observed, the protocol calls for a discussion of the findings among the     research team, followed by a discussion between the clinical lead on the research team and     the primary care provider and/or specialists overseeing a participating patient's care,     possible validation of the assay(s) motivating the discussions, and a decision on how to     intervene on the part of the primary care provider and/or specialists.   "
76132|NCT02289313|"     Approximately one third of the children and adolescents in the United States are either     overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic     groups and households with low socioeconomic status and low parental education. The     Alternative Learning Center (ALC) within Rochester School District 535 provides viable     educational options for students who are experiencing difficulty in regular educational     systems. A greater proportion of students at ALC are minorities, qualify for free and reduced     lunch and receive special education services. These children are likely to have unique     barriers to physical activity and healthy eating.      Specific Aims:      Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors     related to physical activity and eating in ALC students.      Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy     lifestyle.   "
76133|NCT02289300|"     The purpose of this study is to determine whether an investigational drug DCB-BO1202 is     effective and safe in the treatment of liver fibrosis in HBV patients having experienced     intermediate stage hepatocellular carcinoma (HCC)   "
76134|NCT02289287|"     Stroke is defined as a sudden vascular accident that causes brain damage and neurological     impairment. Literature shows that a stroke has a negative effect on participation.     Self-Management (SM) is defined as health promotion and education programs used mostly for     people with chronic diseases, which aim at helping patients to maintain a feeling of     wellness. The primary aim of this study is to assess the effectiveness of a group-based SM     program for post-stroke patients in a community setting, and its contribution to improving     participation, compared to standard care.   "
76144|NCT02289157|"     The investigators propose a prospective, randomized trial evaluating the use of negative     pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators     hypothesize that negative pressure wound therapy will decrease the wound complications in     these patients. The investigators aim to look at all wound complications such as infection     and disruption and will be using Prevena incision management system for our NPWT device .   "
76145|NCT02289144|"     This is an, open-label, protocol designed to evaluate the activity of targeted therapy in     anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC with mutations or     rearrangements detected in the ALK gene.      There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or     metastatic setting. Ceritinib will be administered to the patient until disease progression     by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial     for any other reason.      The primary focus of this arm of the protocol is identifying ceritinib's activity in     anaplastic or undifferentiated thyroid cancer patients. Those patients with mutations     identified in their ALK gene by sequencing their tumor samples, or with the established ALK     abnormalities will be treated with ALK-inhibitors. These include the Ventana assay and Vysis     FISH probe, and patients with tumors positive by this assay will also be considered eligible     for therapy on the trial.      Therapeutic Portion:      ARM A: ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2     cycles      Primary Endpoint: The development of progression; new recurrence or distant metastasis, as     well as enlargement of an existing metastasis on radiographic imaging.      Secondary Endpoints:        1. Overall response rate for patients treated with ceritinib as part of the study.        2. Death of study participant due to any cause.   "
76146|NCT02289131|"     Tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse     as part of clinical care. The purpose of this study is to determine how often tooth brushing     should occur for adult patients with breathing tubes (mechanical ventilation), balanced with     equivalence and safety.   "
76147|NCT02289118|"     The central goal of this study is to determine and compare the similarities and differences     in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD),     Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia     (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic     resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If     cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an     optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20     participants, 45-70 years old, with clinical evidence of young onset focal dementia.   "
76148|NCT02289105|"     The overall objective of this project is to assess if an active choice intervention can     increase advance directive completion rates.   "
76149|NCT02289092|"     The Positive Family Support Project seeks to understand some of the factors that increase     success for children in early elementary school, such as positive family support at home.     This study will inform us on ways to help children learn and succeed in school.   "
76150|NCT02289079|"     The purpose of the study is to compare pain control after robotic hysterectomy surgery using     either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis     plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic     assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are     standard of care in these types of surgeries.   "
76153|NCT02289040|"     Acute kidney injury (AKI) complicates over 50% of cardiac surgical procedures in children     where it increases morbidity and the use of healthcare resources. The pathogenesis of AKI is     poorly understood, current diagnostic tests lack specificity and sensitivity, and there is no     effective treatment. Improving outcomes in patients at risk of AKI has recently been defined     as a National Health Service priority. The investigators are currently undertaking a program     of work that is evaluating the role of plasma-derived microvesicles (MV) and MV associated     microRNAs (miRNA) as diagnostic biomarkers or therapeutic targets in cardiac surgery patients     at risk of developing AKI. Preliminary results indicate that these biomarkers may have     clinical utility in adults. An important consideration is whether these biomarkers also have     utility in children undergoing cardiac surgery. Measurement of MV at serial time points in     children presents ethical challenges related to conducting clinical research in critically     ill subjects. It also presents technical challenges related to the very small volumes of     blood that may be sampled safely from babies and infants undergoing surgery. The aim of the     study is to provide estimates of the perioperative variance of MV concentrations in 24     children undergoing cardiac surgery, as well as the frequency of AKI and other adverse     events, protocol adherence and recruitment rates. This will assist with the design of a     subsequent prospective observational study that will consider the role of MV/miRNA in     children undergoing cardiac surgery.   "
76213|NCT02288247|"     The purpose of the study is to understand if there is benefit in continued treatment with a     medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a     standard chemotherapy for prostate cancer), after the prostate cancer has gotten worse when     treated with enzalutamide alone.   "
76214|NCT02288234|"     The telavancin observational use registry (TOUR) will collect data to support study of the     efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in     outpatients being treated in infusion centers who are receiving clinician directed telavancin     therapy.   "
76154|NCT02289027|"     The objective of this trial is to assess in healthy adults the safety and reactogenicity of a     new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the     glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the     immunogenicity of the candidate vaccine and find the most suitable dose for further     deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of     possibly exposed volunteers owning to organisations such as Médecins sans frontières and     susceptible to be deployed in the outbreak zone (named as possibly exposed volunteers). The     other volunteers will be adults with no planned travels to the epidemic zone (named as not     exposed volunteers). The first group will be randomly allocated to two different groups (low     dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of     5x10e10 vp). The second group will be randomly allocated to three different groups (low dose     = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10     vp or placebo = single injection of vaccine diluent). The design will be double-blind.     Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180.   "
76155|NCT02289014|"     Many cancer patients experience their illness as substantial psychological burden. About half     of the cancer patients suffer from severe stress symptoms and around one third of the     patients fulfill the criteria for a clinically relevant psychological disorder (mainly     anxiety disorder and/or major depression). Studies show, that a high level of distress in     cancer patients is associated with more side effects of and a reduced compliance for     oncological treatment.      Today, the efficacy of psycho-oncological interventions is well studied and proven. Besides     the reduction of levels of anxiety, distress and depression, psycho-oncological support     facilitates dealing with physical complaints and increases quality of life. Yet,     psycho-oncological support is rarely utilized by male patients and insufficiently accessible     for many patients (i.a. lack of supply in the respective area, cost issues).      The internet overcomes some of these barriers, as it can be used independently of time and     location. Internet-based therapies are therefore a growing field of interest in research and     there is evidence for treatment efficacy for several psychological disorders. Moreover effect     sizes of traditional face-to-face and interactive web-based interventions are comparable.     However, web-based interventions for cancer patients are still scarce. The present research     project therefore develops a comprehensive stress management program accessible for a vast     number of cancer patients. The study targets primarily to evaluate the feasibility of the     program (technical, organizational feasibility, accessibility). In addition, the preliminary     efficacy of the program will be analyzed in order to adapt future programs for specific     patient groups.   "
76156|NCT02289001|"     Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training     of undergraduate Nursing students will increase their capacity to work in an     interdisciplinary team, the investigators will assess whether introducing the SBAR improves     the students' knowledge of their own role and that of others on the team (medical students),     strengthens communication between team members, and enhances the quality of the patient     assessment and interventions demonstrated by the nursing students caring for a critical     patient (represented by a high-fidelity mannequin, a Human Patient Simulator).   "
76157|NCT02288988|"     True short esophagus (TSE) is present when the distance between the esophago-gastric (E-G)     junction and the apex of the hiatus is shorter than 2.5 cm, without the application of any     downward pressure on the stomach, after maximal mobilization of the distal thoracic     esophagus. It has been demonstrated that TSE is present in 20% of patients undergoing routine     surgery for gastro-esophageal reflux disease (GERD), and in more than 50% of cases of type     III-IV hiatal hernia (HH) that are treated surgically. Recent reports have confirmed the     importance of diagnosing and electively treating TSE to reduce the risk of anatomic     recurrence after surgery. The surgical techniques currently used for the elective treatment     of TSE are based on the association of the Collis gastroplasty with an anti-reflux     funduplication and the hiatoplasty, performed using minimally invasive techniques; the     mortality, morbidity, and outcomes of these procedures remain subjects of debate. In light of     the doubtful validity of the surgical results for TSE, some researchers have proposed that     this condition should not be treated with surgical therapy. In the absence of randomized,     multicenter studies designed to compare the surgical techniques used to treat TSE, the     investigators believe that data obtained from a single-center study may be useful to the     surgical community, provided that such data are based on an objective intra-operative     diagnosis of TSE and a rigorous follow-up period.   "
76159|NCT02288962|"     Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the     symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near     future will undergo pituitary surgery. The remaining adenomas are monitored regularly.     Operation of these large adenomas will rarely remove all tumour tissue, and there is also a     risk of worsening of pituitary function. Often, adenomas with the highest growth potential     are operated several times and some also need radiation therapy, providing additional risk     for pituitary failure (4). Unlike some of the hormone-producing adenomas, there is no     established pharmacological treatment for NFPAs. However, there are a few non-randomized     studies suggesting that treatment with dopamine agonists may slow growth, and also induce     tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the     treatment of pituitary adenomas secreting prolactin.      Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary     adenomas on the change in tumour volume.   "
76160|NCT02288949|"     The American-European Consensus Conference (AECC) and the Berlin definitions of the Acute     Respiratory Distress Syndrome (ARDS) could be adequate for epidemiologic studies, but it is     not adequate for inclusion of patients into therapeutic clinical trials. Despite recent     reports on the effects of standardized ventilator settings on PaO2/FIO2 and fulfillment of     AECC and Berlin definitions of ARDS, it is still a matter of debate whether the assessment of     hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in patients     with ARDS. The investigators will perform an observational, multicenter, prospective audit in     a network of intensive care units in Spain and China for validating and confirming that the     assessment of hypoxemia at 24 hours after ARDS onset is the most valuable tool for     stratifying and predicting outcome in patients with ARDS.   "
76161|NCT02288936|"     Prostate cancer is the most common non-skin tumor diagnosed in men and the second leading     cause of cancer death in men in Western countries.      Between 10-20% of patients are diagnosed at metastatic stage and about half of those     diagnosed in early stages will develop metastases.      After the clinical benefit of mitoxantrone and the improved survival of 2-3 months provided     by docetaxel in first line, the second search is driven to look for effective second lines     treatments. In recent years, there are new drugs for the treatment of prostate cancer,     revolutionizing the therapeutic sequence and survival.      Thus, androgen deprivation therapy, treatment of choice, induces an improvement of symptoms     in approximately 70-80% of patients, but it is limited by the development of mechanisms of     resistance to androgen deficiency. Docetaxel was the first chemotherapy drug to increase     survival in patients with metastatic prostate cancer. The second cytotoxic drug approved in     the second line treatment of metastatic CRPC has been cabazitaxel.      Enzalutamide improves survival in patients with metastatic CRPC who had progressed to     chemotherapy and also in patients who had not received chemotherapy.      To date, there are no biomarkers available that allow us to identify which patients from a     clinical or molecular view are those that will be able to benefit from the treatment options     currently available. The presence of the TMPRSS2-ETS rearrangement has been shown to     correlate with efficacy in clinical practice abiraterone.      There is scientific and preclinical background that makes one suspect that the molecular     alteration may influence the same way enzalutamide antiandrogen activity, but it has not been     determined to date.      The objective of this study is to determine whether the efficacy and safety of enzalutamide,     when administered to patients with castration resistant prostate cancer prior to     administration of docetaxel is influenced by the presence or absence of the fusion gene     TMPRSS2- ETS.   "
76162|NCT02288923|"     Pain after a knee replacement can impair recovery and use of the new knee. Having an     injection to numb the femoral nerve is known to give good pain relief after the operation but     may lead to slower mobilisation as it also prevents the patient from moving the knee. Recent     studies have shown that infiltration of local anaesthetic (LIA) within the new knee joint may     also give good pain relief. The null hypothesis is that there is no difference in primary or     secondary outcome measures between femoral nerve block and LIA, as anaesthetic techniques for     knee replacement.   "
76163|NCT02288910|"     This project investigates the feasibility of assessing the relative blood volume of     carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from     pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an     interventional platform.   "
76164|NCT02288897|"     This is an international multicenter, open-label, randomized controlled trial (RCT) of     single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic     viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1)     are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint     inhibitor. Subjects in the comparator arm will receive the Investigator's choice of     dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as     determined by Investigator preference and standard of care in the Investigator's country or     region. Effectiveness will be assessed by comparison of progression-free survival (PFS)     between all intent-to-treat (ITT) subjects in the two study treatment arms.   "
76165|NCT02288884|"     The purpose of this study is to determine the effect of a silver containing dressing     (Acticoat Post-Op) compared to a standard dressing (OpSite PostOp) on post elective cesarean     section wound complications in obese women (BMI >35).   "
76166|NCT02288871|"     The purpose of this study is to determine why sutureless aortic bioprostheses apparently     offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients     who underwent aortic valve replacement.      Our approach to address this question is the combination of clinical data with the     application of specifically validated experimental and computer based analyses to compare the     performance of these valves under patient-specific conditions.   "
76167|NCT02288858|"     The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted     for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement     compared to a placebo in female subjects with self-perceived thinning hair associated with     poor diet, stress, hormonal influences, or abnormal menstrual cycles.      Viviscal is an oral food supplement specifically designed to promote the quality of existing     hair growth and/or to promote new hair re-growth for women suffering from temporary thinning     hair. It does not contain hormones, drugs, or industry by-products. Viviscal has been     marketed in Europe for over 15 years. The key ingredient is AminoMar C - a protein rich     compound of marine extracts blended with soluble silica and fortified with Vitamin C.     Viviscal provides essential nutrients to nourish hair naturally from within. Viviscal works     over several months of use to improve the appearance of thinning hair.   "
76168|NCT02288845|"     The purpose of this study is to determine the relationship between ITI-007 dose, plasma     levels and brain receptor occupancy in patients with stable schizophrenia.   "
76232|NCT02288000|"     The early assessment of new drugs for Alzheimer's disease remains difficult because of the     lack of predictive end-point. The use of a battery including different parameters could     improve this early development of new drugs. Nevertheless, the interest of such a battery     should previously be validated with the yet marketed AD drugs.   "
76169|NCT02288832|"     Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries     have no abnormal history. It is widely agreed that preterm delivery is often associated with     bacterial vaginosis. One of the major difficulties at this time is that the diagnosis of     bacterial vaginosis is based on heterogeneous criteria. The technique currently used is the     Nugent score, but it lacks the characteristics necessary for widespread use in the general     population. It must be performed on a fresh swab, and any delay in transporting it can cause     drying that makes the test difficult to perform.      The investigators have developed a rapid diagnostic tool for bacterial vaginosis using     molecular biology based on a point of care model and obtained a patent (European Patent     Office N° 2087134). In comparison with the reference techniques, our tool's performance has     been excellent, in terms of specificity, sensitivity, and positive and negative predictive     values. In particular, our work showed that 57% of the flora samples rated as intermediate on     the Nugent score were in reality true bacterial vaginosis. Molecular biology therefore     identifies a homogeneous population of women with vaginal flora anomalies. The investigators     recently showed that the carriage of Atopobium vaginae and/or Gardnerella vaginalis >105/mL     shortens the time to delivery in a population at risk of preterm delivery (PHRC 2006).     Vaginal flora anomalies are therefore an important target for preventing preterm delivery.   "
76170|NCT02288819|"     The primary objective of this study is to assess whether the urinary sodium/creatinine or     chloride/creatinine ratio might predict successful downtitration of loop diuretics in     patients with stable heart failure without clinical signs of volume overload. In addition,     this study will provide information on loop diuretic efficiency and urinary electrolyte     composition after intake of diuretics in stable outpatients with heart failure.   "
76171|NCT02288793|"     The study evaluates the knowledge and attitude about Focused Assessment with Sonography in     Trauma examination among medical students and medical staff in Poland.   "
76267|NCT02287545|"     Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after     trabeculectomy.   "
76172|NCT02288780|"     Transurethral resection of the prostate (TURP) is a standard surgical treatment for benign     prostatic hyperplasia (BPH). Non-conductive irrigation fluid is used to maintain good     visibility of the operating field during resection of the prostate. Absorption of this     hypotonic solution into the bloodstream can cause fluid overload and dilutional hyponatremia,     resulting in adverse cardiovascular and central nervous system effects, transurethral     resection (TUR) syndrome. BPH is common in elderly men above 60 years old. These aged people     commonly have diastolic impairment by normal physiologic change without consistent symptom.     This study aimed to evaluate the cardiac function focused mainly diastolic function during     TURP with transthoracic echocardiography. Also, we will focus the effets of amount of     irrgation fluid on left ventricular diastolic function in patients with pre-existing     diastolic dysfunction.   "
76173|NCT02288767|"     During an enterectomy, especially in an open surgery, large amounts of fluid are administered     in consideration of the patient's fasted state, maintaining blood pressure during surgery and     potential third space loss. However, it has recently been reported that excessive fluid     administration during surgery is actually detrimental to patients' prognoses. In fact,     several reports have suggested that compared to limited fluid administration, excessive fluid     administration increased the length of stay or the chances of complications. Thus,     goal-directed fluid optimization is required during surgery because only a proper amount of     fluid (neither limited nor excessive) administration can minimize postoperative complications     and enhance prognosis. In general, the amount of fluid administered is determined with regard     to the patient's volume status, including a comprehensive assessment of vital signs such as     the pulse rate and blood pressure, and urine volume. However, this method has limitations in     that it is an inadequate indicator of the actual intravascular volume of a patient to     determine and administer the proper amount of fluid. Recently, new methods of measuring     volume status that are less invasive and more accurate have been introduced. These methods     include stroke volume variation (SVV) that monitors changes in arterial pressure waveform     amplitudes with regard to breathing patterns. This is an effective method of monitoring fluid     responsiveness after placing a catheter via a radial artery puncture. The stroke output is     dependent on the preload, afterload, and cardiac contractility. The cardiac output is     determined by multiplying the stroke output and heart rate. SVV indicates the difference in     stroke output within one breathing cycle. A direct or indirect measurement of stroke output     is required, which can be performed by analyzing arterial pressure waveforms via a FloTrac     Sensor (Edwards Lifesciences, USA) monitor. SVV is known to have a high fluid responsiveness     even during open surgeries, yet there is practically no research data on its effect in     patients' postoperative recovery and prognosis in comparison to the traditional methods of     fluid administration. Therefore, the investigators will apply SVV via a FloTrac/ Vigileo™     monitor on patients undergoing bowel resection to determine whether it better assists proper     fluid administration compared to the traditional method of fluid administration by examining     the patients' postoperative prognosis such as bowel movement recovery and length of stay.   "
76174|NCT02288754|"     The aim of this study is to employ genomic detection methodologies to measure the relative     amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic     disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy     treatment. More generally, this approach will allow us to develop a quantitative measure of     therapy efficacy via the counting of the relative changes in tumor molecules over the course     of treatment.   "
76175|NCT02288741|"     Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively     randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1)     or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be     randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was     scheduled for all patients.   "
76176|NCT02288728|"     Gastric cancer as one of the most common gastrointestinal cancers, radical resection of     primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons     all over the world. When compared with the advanced upper third gastric cancer, proximal     gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric     cancer located in the upper third of the stomach. However, due to abandon the anti-reflux     barrier of the digestive system caused by the dissection of the cardia and the lower     esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as     well as the reflux esophagitis caused by the traditional esophagostomy permanently influence     the postoperative quality of life for those patients. Nowadays, relationship between the     digestive track reconstruction for proximal gastrectomy and the postoperative quality of life     is still with controversies. Previous study reported the gastric tube anastomosis can     minimize the reflux related symptoms when compared with traditional esophagogastrostomy.     There still exited some patients need long-term anti-acid drug to control the reflux symptoms     although underwent the gastric tube anastomosis. The double-track anastomosis for proximal     gastrectomy may successfully control the reflux symptoms and there existed study found it is     as safe as the esophagostomy. But there has no randomized control study to compare the     postoperative quality of life between the gastric tube anastomosis and double-track     anastomosis for proximal gastrectomy.      By the reasons above, a randomized controlled trial is conducted with the intention to     compare the intraoperative and postoperative mortality and morbidity and the postoperative     quality of life between the esophagogastrostomy and the double-track anastomosis in the     proximal gastrectomy for gastric cancer patients.   "
76177|NCT02288715|"     The purpose of the study is to evaluate whether variability of CPP (cerebral perfusion     pressure) is related to sepsis-associated encephalopathy and outcomes of patients with     sepsis.   "
76233|NCT02287987|"     Prospective, randomized trial comparing surgical, functional and oncological outcomes between     clamp and clamp-less robot assisted partial nephrectomy.   "
76178|NCT02288702|"     About 1 in every 700 babies born in the United States has Down's Syndrome (DS; Trisomy 21),     99% of whom have some degree of intellectual disability. Recent advances in medicine have     resulted in a dramatically improved lifespan of about 25 to 60 years of age. Yet, there is     limited data about anesthetic management in this increasing patient population. The     bispectral index (BIS) monitor is a non-invasive monitoring device that reports a value     between 0 and 100correlating to level of consciousness of an individual. A value of 0     indicates lack of brain activity while 100 indicates an awake/alert state. This monitor can     be used to assess the depth of anesthesia. Patients with intellectual disability from     congenital neurological diseases have lower BIS values compared to patients without any     neurological impairment (Valkenburg 2009). The results may suggest that DS patients would     require less anesthetic drugs compared to patients without any neurological impairment. To     date, there are no studies in DS patients.   "
76179|NCT02288689|"     In this study the investigators aim to compare the cervical dilation time in pregnant     patients at term who had clinical evaluation of the cervical consistency with patients who     had also quantitative measurement of the cervical elasticity in .   "
76180|NCT02288676|"     This study will determine whether a genetic test of Pap samples detects ovarian and     endometrial cancers.   "
76204|NCT02288364|"     The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding     sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core     biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can     cause pain for approximately 15 seconds until the numbing effect begins. It is possible that     this pain is caused because lidocaine is acidic. Some physicians believe that reducing the     acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of     injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1%     lidocaine mixed with sodium bicarbonate - are used as routine standard of care by     radiologists today. The purpose of this study is to determine if either approach is more     comfortable for patients having breast procedures.   "
76277|NCT02287415|"     Multiple-dose, open-label, single-period study consisting of three consecutive phases   "
76181|NCT02288663|"     Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The     reference technique to measure GFR (clearance of a glomerular agent) is not commonly used.     Instead, estimations (eGFR) are routinely taken from serum creatinine (SCr) with several     published formulae: Cockcroft and Gault, MDRD, CKD-EPI. Basically, all these formulae aim at     predicting the endogenous creatinine production by morphological parameters (age, body     weight...) However, in the elderly, muscular mass is extremely variable and sarcopenia is     quite commonly encountered (frequently linked to Alzheimer disease). This is probably the     main reason why the aforementioned formulae are not valid in this population: for a given     renal function, a lower muscular mass induces a lower creatinine production and, henceforth,     a lower SCr value, which gives an overestimation of eGFR.      Muscular mass is closely linked to lean body mass (LBM), which can be properly assessed by     whole-body dual X-ray absorptiometry (DXA). Alternatively, Bioelectric Impedance Spectroscopy     (BIS) can also be used.      Investigators postulate that it is possible to estimate GFR in the elderly from both SCr and     LBM estimation from DXA. Proof of concept has already been made by others but until now, no     specific formula for the elderly has been devised and properly validated.      Investigators'aim is thus to propose a new formula to predict GFR from both SCr and LBM     (estimated from DXA) in the elderly. This formula will be elaborated from a first series of     100 patients and validated on a second series of 100 other patients.   "
76182|NCT02288650|"     At the child, the post-operative vomitings (POV) remain the main post-operative complication     in term of frequency. They also represent the first cause of unforeseen hospitalization in     day case surgery. The causes of POV are multiple, including in particular the post-operative     prescription of opioids. The role of the premature refeeding remains discussed.      Up to the age of 4 years, acute pain is difficult to distinguish from other causes of     distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in     post-operative.      The main objective of this study is to estimate the POV in pediatric day case surgery after     early refeeding with clear liquids in the recovery room or only in the day case wards (usual     practice).      The secondary objectives are to estimate the time on returning to the day case ward, at home,     the post-operative opioid consumption, early refeeding adverse effects (desaturation,     swallowing trouble)   "
76183|NCT02288637|"     The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes     region in Tanzania comparing the relative effectiveness of 4 vector control interventions for     reducing malaria transmission and controlling vector populations in an area where An gambiae     s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net     (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting     indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or     4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN     which incorporates a PBO synergist.      The trial will provide epidemiological, entomological, economic and social evidence of     impact, as the investigators shall be measuring the reductions in malaria prevalence and     malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species     ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel     LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s.     and reducing malaria prevalence than current practice with the conventional LLIN. There is     great interest in conducting this trial. Alternative vector control products are limited and     most new insecticides are not suitable for use on LLINs or as IRS.   "
76184|NCT02288624|"     This is a human dietary intervention study that is randomized and crossover in design with 4     treatment arms consisting of control, orange juice,whole orange, and processed whole orange     to investigate the satiety effects of the treatments in healthy volunteers. Self reported     hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different     time points prior to and post consumption of each treatment.   "
76304|NCT02287064|"     The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect     Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system     function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6, 10     and 11.   "
76185|NCT02288611|"     This aim of this study is to investigate the prebiotic potential of date fruits in healthy     human volunteers compared to a control diet. Each arm was 21 days in duration, separated by a     14 days washout period. Faecal samples, and blood samples will be collected from each     volunteer and high resolution analytical techniques (HPLC, LC-MS and NMR) will be employed to     characterise the whole system metabolic response to ingestion of date fruits compared to the     control. Changes in microbial parameters and metabolite profiles will be correlated with     changes in biomarkers of chronic disease, including faecal water genotoxicity, cellular     reactions, blood lipids and bowel movements.   "
76186|NCT02288598|"     This study aims to test whether the addition of transcranial direct current stimulation     (TDCS) to speech fluency training results in improvements in speech fluency in adults with     developmental stuttering. Half of the participants will receive anodal TDCS on five     consecutive days, the other half will receive a sham stimulation for the same amount of time.   "
76187|NCT02288585|"     Double-blind, randomised, placebo-controlled, parallel group study with two intervention     arms. The study will be conducted in 150 subjects and the primary objective is to show a     fasting LDL-cholesterol and triglyceride lowering effect of plant sterols in subjects with     established type 2 diabetes mellitus and subjects at high risk of developing type 2 diabetes.   "
76205|NCT02288351|"     The purpose of this study is to investigate small intestinal remodeling and reprogramming of     glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic     Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein     expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major     mechanism for the remission of T2DM following RYGB.      The two aims of the study are: 1) to demonstrate that the basement membrane glucose     transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate     that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control     observed in T2DM patients undergoing RYGB.   "
76206|NCT02288338|"     A randomized open-label, multiple dose, three-treatment, three-period, six-sequence,     crossover study to investigate the pharmacokinetic drug interaction between Atorvastatin and     Ezetimibe after oral administration in healthy volunteers   "
76207|NCT02288325|"     This study evaluates the efficacy, safety and tolerability of levomilnacipran     extended-release (ER) compared with placebo in the prevention of depression relapse (MDD).   "
76188|NCT02288572|"     The metabolic syndrome is increasing worldwide, including developing countries. The metabolic     syndrome is composed of clinical expressed symptoms as central obesity, high blood pressure,     raised fasting plasma glucose or diagnosed diabetes, low HDL, and raised serum triglycerides.     All those components together or independently contribute to the development of     cardiovascular diseases, which are the leading cause of death in the modern world. The     results from previous studies have shown that probiotic bacteria have an influence on health     improvement, and can exert positive effects on diseases as diabetes, high blood pressure,     dyslipidemia and low-grade inflammation, which are all components of the metabolic syndrome.     The objectives of this study were to investigate which of probiotic strains Lactobacillus     plantarum PCS 20, Lactobacillus plantarum PCS 26 in Lactobacillus rhamnosus GG exert positive     effects in the cascade of molecular reactions at the level of small intestines, at remodeling     of monocytes/macrophages and adipocytes in human cell model of non-cancerous origin, and to     provide scientific explanation of mechanisms of possible multi-leveled activity of selected     probiotic strains in patients with metabolic syndrome. For this purpose, the investigators     divided this research into two parts. The first part consisted of pre-clinical in-vitro     laboratory study. It examined the mechanisms of actions of probiotic cultures with the use of     functional cell models of non-cancerous origin, more specifically, with the use of cell lines     of human intestinal epithelium, human monocytes/macrophages and human visceral preadipocytes.     In in-vitro laboratory study, the investigators demonstrated that probiotic strain     Lactobacillus plantarum PCS 26 exerts positive effects, which could help to relieve the     particular components of the syndrome in the host with metabolic syndrome. The second part of     the research consisted of prospective, double-blind and placebo-controlled in-vivo pilot     clinical study, which included 16 volunteers with the metabolic syndrome. Results have shown     that probiotic strain Lactobacillus plantarum PCS 26 exerts positive effects on reduction of     waist circumference, on lowering of serum cholesterol concentration, and on maintenance of     serum adiponectin levels. Those effects together can contribute to the alleviation of the     metabolic syndrome, especially in terms of clinical manifestation and risks in relation to     cardiovascular diseases.   "
76189|NCT02288559|"     This multicenter, randomized, single-masked, sham injection-controlled study will investigate     the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks     (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA)     secondary to age-related macular degeneration (AMD). A safety run-in assessment will be     conducted prior to initiating enrollment in the randomized study.   "
76190|NCT02288546|"     This research concerns nutritional and toxicological health risk evaluation among long-term     vegans. Research focus is in cumulative exposure to pesticides.   "
76191|NCT02288533|"     Chronic consciousness disorders have high level of impact on public health and its costs.   "
76192|NCT02288520|"     This is a longitudinal, observational, prospective, multicentre study conducted in     metropolitan France, among a representative sample of office-based or mixed practice     rheumatology doctors.      The aim of this study is to describe in real life, the therapy strategy when faced with a     patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and     the impact on the progression of the disease at 6 months.   "
76193|NCT02288507|"     This study evaluates the safety and efficacy of administering sorafenib concurrent with     yttrium-90 radioembolization to patients with advanced hepatocellular cancer.   "
76194|NCT02288494|"     The primary purpose was to describe the acid base balance of ICU patients with severe     hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human     albumin perfusion.   "
76195|NCT02288481|"     The objective of this study is to evaluate the safety and tolerability of single oral doses     of TBA‐354 when administered to healthy adult subjects.   "
76196|NCT02288468|"     Randomised, active controlled, double blinded (patient and observer blinded), monocentric     trial with three treatments, three periods and six treatment sequences allocated according to     a Williams design   "
76197|NCT02288455|"     The purpose of this investigation is to demonstrate the safety and efficacy of the GTU     artificial urinary sphincter device in restoring continence in males who have confirmed     urinary stress incontinence for a minimum of 12 months with primary etiology being radical     prostatectomy or transurethral resection of the prostate (TURP).   "
76198|NCT02288442|"     The purpose of this RCT is to study the effects of whole muscle training (inspiratory muscle     training + aerobic training + muscle resistance training) on muscle power, VO2peak and     gas-exchange variables obtained during cardiopulmonary exercise testing, QoL, functional     capacity (eg, 6-min walking distance), and maximal inspiratory pressure in patients with     pulmonary artery hypertension.   "
76199|NCT02288429|"     Colistin is a polymixin antibiotic used in the treatment of multidrug-resistant gram-negative     infections. Given the limited use of colistin and previous challenges with laboratory assays     to determine plasma concentrations, there is a lack of knowledge of the pharmacokinetic     profile of colistin. The purpose of the investigators observational prospective     pharmacokinetic cohort study is to examine the steady-state pharmacokinetic and     pharmacodynamic properties of intravenous colistimethate sodium in cystic fibrosis and     critically ill patients.   "
76200|NCT02288416|"     This pilot trial studies a video-based intervention in reducing anxiety in patients     undergoing lung cancer screening. Giving a video-based intervention to patients prior to lung     cancer screening may reduce anxiety and improve the well-being and quality of life.   "
76201|NCT02288403|"     Aerobic exercise produces increases in cardiorespiratory fitness (CF), which constitute a     protective factor for cardiovascular disease and all-cause mortality. Therefore, aerobic     exercise is a key strategy to promoting cardiovascular. There is some evidence that aerobic     high intensity interval training may lead to greater increases in CF compared with continuous     moderate-intensity training.      The main objective of this study is to examine the effects of an aerobic high intensity     training program versus a continuous moderate intensity training program on CF in men 18 to     44 years.   "
76202|NCT02288390|"     Dental plaque score calculation and swabs of Oropharynx and teeth were collected on     admission. For group I, Miswak stick was used 4 hourly for oral care. For group II, 0.12%     Chlorhexidine/ toothbrush were used 4 hourly   "
76203|NCT02288377|"     This European, prospective, multicentre, double-blind randomised study will evaluate the     effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in     patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine     tumours.   "
76208|NCT02288312|"     Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence     study in 18 healthy male and female subjects.   "
76209|NCT02288299|"     The long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance     in home non-invasively ventilated (NIV) patients suffering from neuromuscular disease will be     assessed in a prospective, randomized, cross over, open label study   "
76210|NCT02288286|"     The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried rabies     vaccine (MRC-5 cells)in different age health human populations, according to the traditional     Essen methods (1-1-1-1-1) vaccination.   "
76215|NCT02288221|"     All over the world the increasing prevalence of chronic disorders and its impact on     functional decline is challenging the sustainability of health care systems. Older     individuals also frequently experience the reversible frailty syndrome, which overlaps with     chronic diseases, increasing incidence of disability.      Building a global system aiming to take in charge all causes leading to loss of autonomy is a     rather complicated task involving numerous Information and Communication technologies (ICT)     solutions which are not always easy to use in everyday life.      The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality     of life of older people at risk.      The SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation     aromatherapy automatic fragrance, training interface based on Kinect sensor...) .      The goal of this study is to validate the acceptability, sensitivity and efficacy of the     systems.   "
76216|NCT02288208|"     This study evaluates the addition of birinapant in subjects with chronic Hepatitis B who are     currently receiving anti-viral therapy with either tenofovir or entecavir. Patients will     receive either birinapant or placebo in addition to their anti-viral therapy.   "
76217|NCT02288195|"     Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced     rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term     toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could     improve overall survival. The purpose of this study is to compare the effects of chemotherapy     alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and     selective use of the standard treatment to the standard treatment of chemotherapy and     radiation.   "
76218|NCT02288182|"     A randomized controlled clinical trial to investigate the capability of Straumann® VivOss™     compared to Geistlich Bio-Oss in sinus floor augmentation to demonstrate superiority of     Straumann® VivOss™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed bone     to residual bone substitute.   "
76219|NCT02288169|"     Regardless of their treatment, cancer patients endure a variety of difficult symptoms during     their disease with averages ranging from 7 to 14 symptoms each. Cancer-related symptoms,     especially when symptoms are very intense, distressing, frequent, or interfere with daily     activities, can lead to depression, anxiety, and diminished quality of life. Improving their     ability to self-manage difficult symptoms has the potential to diminish suffering, improve     quality of life and decrease emergency room visits and associated costs. The investigators     propose to test a brief, effective intervention with outpatients in a cancer center, with the     goal of teaching patients symptom management skills for self-identified symptoms of highest     priority to patients. Objective: The proposed randomized clinical trial will test the     efficacy of the COPE intervention with patients with symptoms of moderate to high intensity,     distress, frequency or interference with their lives as a result of their cancer. Method: The     investigators will seek 300 completed subjects, outpatients with breast, colorectal, lung,     and prostate cancers. Patients will be randomized into three groups. Group III, the     experimental group, will receive usual care plus the COPE intervention. This group will     receive 3 individual intervention sessions. During the first intervention visit at the cancer     center, the COPE group will be taught the COPE intervention in a session focusing on the     patient's self-identified most bothersome symptom. Role modeling and additional instruction     will be provided via video, and patients will receive the Home Care Guide for Cancer and a     copy of the video to take home. Three subsequent visits with the patient during regularly     scheduled clinic visits will reinforce the principles of COPE and the use of the Home Care     Guide, and will help patients apply this approach to managing other symptoms. In addition     they will get 2 phone calls encouraging them to apply COPE. Group II, the attention control     group, will receive supportive visits from the research team at the cancer center and     subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls,     matched for time with COPE participants. Group I, the control group receiving usual care,     will receive no additional attention from our interventionists. Data will be collected weekly     for 9 weeks about symptoms (intensity, frequency, interference, appraisal of distress),     self-efficacy, and barriers to self-management. Patient Outcomes: Quality of life, anxiety     and depression will be assessed at baseline and weeks 4, 8, and 12. The investigators predict     that the COPE group will show significant improvement in depression, anxiety, quality of     life, symptom intensity, distress, frequency and interference, self-efficacy, and perceived     barriers to care, as well as decreased utilization of health care resources compared with the     two control groups. Data will be analyzed using repeated measures multivariate analysis of     variance using a mixed model approach.   "
76234|NCT02287974|"     To study the effect of the stem cells therapy autologous mononuclear from the bone marrow,     autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal     stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and     the decrease of the needs of insulin, besides evaluates the safety, viability and efficiency     of the intra-arterial infusion of stem cells in diabetic patients type 2 with CLI.   "
76220|NCT02288156|"     Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is     estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic     inflammation of the inner lining of the nose and is characterized by the following symptoms:     rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining     rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than     twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the     knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and     non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic     rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal     spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM     (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal     spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in     VAS for major nasal symptom on week 4.      (Estimated placebo effect is 25%.)   "
76221|NCT02288143|"     This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled     ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of     oocytes retrieved.   "
76222|NCT02288130|"     Rationale: Laparoscopic myomectomy is increasingly performed over laparotomic myomectomy,     because of the many benefits for the patient in terms of pain, hospital stay and recovery. In     order to increase the success rate of a laparoscopic procedure pre-treatment to decrease the     volume might be beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for this     purpose with good results in terms of volume reduction, but sometimes resulting in loss of     distinction of the right surgical planes. Ulipristal is a new pre-operative treatment option     for symptomatic fibroids, which has demonstrated good results in terms of volume reduction.     The effect on cleavage planes is unknown. This study is performed to evaluate if Ulipristal     is as effective as GnRHa in terms of surgical outcome.      Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative     blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life     and costs.      Study design: Double blind randomized controlled multi-center trial. Study population:     Premenopausal women in whom a maximum of 2 symptomatic intramural fibroids between 5 and 12     cm in diameter will be removed. Fibroid types 3, 4, 5, 6 and 2-5 will be included.      Intervention: Three months of Ulipristal 5 mg once daily combined with a single saline     injection at the onset of pretreatment (produced as placebo of Leuproreline) or (comparison)     11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once     daily) .      Methods: Within 1 month after pre-treatment patients will undergo a laparoscopic myomectomy     by experienced surgeons. Operative characteristics will be recorded prospectively. Follow up     will be 6 months after surgery mainly for quality of life assessment. A cost utility analysis     will be conducted alongside the trial.      Main study parameters/endpoints: Ulipristal is non-inferior to GnRHa in terms of blood loss     during surgery when the average difference between the two groups is below 150 ml (standard     deviation 250 ml).      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Both Ulipristal and GnRHa have been registered for this indication. Safety has     been tested and no specific risks apply.   "
76223|NCT02288117|"     The objective of this PMCF is to collect clinical and radiographic outcome information on     Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine     conditions.      The results collected will be used to clinically confirm the performance and safety of the     LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF.     Furthermore the results can be used for future regulatory processes if needed.   "
76224|NCT02288104|"     This study is a prospective study in order to demonstrate the technical feasibility and     safety of doing endomicroscopic imaging during interventional radiology procedure in two main     indications: Kidneys and liver.      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The     proposed study is a feasibility study.   "
76225|NCT02288091|"     This is a single center, open label, 12-week study of inosine treatment. Inosine treatment     leads to an increase in the levels of urate (uric acid) in the blood.      The primary objective of the study is to determine the safety and tolerability of oral     administration of inosine.      Secondary study objectives include the measurement of biomarkers of oxidative stress and     damage in response to inosine treatment.   "
76226|NCT02288078|"     The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic     effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from     regorafenib treatment, as well as to assess treatment continuation of regorafenib.   "
76227|NCT02288065|"     Retrospective survey for factors predicting the outcome of medical thoracoscopy   "
76228|NCT02288052|"     The basal ganglia play an important role in motor learning, especially during the     consolidation phase of motor learning. This raises the question whether it is possible to     sustain learning increments in a neurodegenerative condition such as Parkinson's disease     (PD). The aim of this study is to gain knowledge on whether it is possible to relearn skills     which are actually affected by PD, such as writing, and determine whether neuroplasticity is     possible. In this randomized controlled study, PD patients will either follow intensive     writing training or a placebo treatment (stretch and relaxation training) during 6 weeks. The     writing training will focus on automatization (withstanding dual task interference), transfer     to an untrained task and retention. The placebo program is aimed to reduce stiffness in the     upper limbs and has been shown to be ineffective in PD. To date, it is unknown how neural     networks change as a result of consolidation after a prolonged period of motor learning in     PD. Therefore the second arm of this study will investigate, for the first time, changes in     neural connectivity using brain imaging data to elucidate which neuroanatomical regions are     involved in consolidation of learning in PD. Finally, DTI and resting state fMRI-analysis     will complement insights into the neural changes as a result of learning.   "
76229|NCT02288039|"     The main aim of pulmonary rehabilitation is to improve the quality of life of patients that     have been diagnosed with chronic lung disease. The challenge for pulmonary rehabilitation is     that many patients do not complete their agreed or prescribed training targets which may be     related to the way pulmonary rehabilitation is delivered. There is a belief among doctors and     other healthcare professionals delivering pulmonary rehabilitation care that patients who are     working together as part of a group may better accomplish their agreed training targets     (intervention). The intervention aims to encourage members of the group to interact and     support each other during the rehabilitation sessions in order to attain agreed pulmonary     rehabilitation goals   "
76230|NCT02288026|"     The purpose of this study is to compare early-stage peripheral non-small cell lung cancer     lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective     for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as     lobectomy.   "
76235|NCT02287961|"     Multicentric epidemiological non-comparative study in France characterising evolution of anal     Human papillomavirus (HPV) infection and related lesions and evaluating markers associated     with the observed evolution.      Estimated enrolment: 500      Principal Outcomes        -  Detection of high-grade cytological and histological anal lesions by high resolution          anoscopy        -  Spontaneous regression of high-grade anal lesions        -  Detection of anal HPV infection      Intervention (procedure):        -  Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up          visits and if applicable Month 6 and Month 18 control visits)        -  Standard proctologic examination with digital rectal examination and 2 anal swabs          (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month          6 and Month 18 control visits)        -  High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up          visits and if applicable Month 6 and Month 18 control visits)      Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High     Resolution Anoscopy (HRA):      - anal biopsy(ies) during HRA      Only if high-grade lesion:      - HRA biannually   "
76236|NCT02287948|"     Balance disorders are frequently observed in patients with Multiple Sclerosis (MS) and the     deterioration of the static and dynamic control of balance is an important and basic symptom     of disease progression.      Measure balance disorders with force platforme requires personnel and represent a significant     cost.      The platform Nintendo Wii Fit represents a valid economic alternative   "
76237|NCT02287935|"     It was investigated whether there is a factor that can aid determination of the preferred     technique by comparing the early Limberg flap and Karydakis procedure techniques for the     treatment of recurrent pilonidal sinus.   "
76238|NCT02287922|"     The primary objective of this study is:      - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered     subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).      The secondary objectives of this study are:        -  To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),          pharmacodynamics (PD), and immunogenicity of ALX 0061 and to explore potential dose          regimens for ALX 0061 monotherapy, based on safety and efficacy, for further clinical          development.        -  To obtain parallel descriptive information concerning the efficacy and safety of          tocilizumab (TCZ) s.c. in the same clinical trial RA population.   "
76239|NCT02287909|"     The recommended antiplatelet treatment regimen for patients affected by acute coronary     syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in the     combination of aspirin and a P2Y12 receptor inhibitor. More potent P2Y12 receptor inhibitors,     such as ticagrelor, have been developed which are associated with less response variability     than clopidogrel and better clinical outcomes. Ticagrelor use has increased significantly     because of its more expanded Food and Drug Administration (FDA) indications compared with     prasugrel. However, despite the evidence for sustained efficacy and safety, many physicians     limit treatment duration with ticagrelor to the early phases following an ACS mostly due to     cost issues and concerns about increased bleeding. Therefore, it is very common in clinical     practice to switch patients while on maintenance dosing (MD) with ticagrelor to treatment     with clopidogrel. However, the pharmacodynamic (PD) effects of switching from ticagrelor to     clopidogrel remain unknown. Therefore, the aim of this investigation is to evaluate the PD     effects of switching from ticagrelor to clopidogrel.   "
76240|NCT02287896|"     The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in     RhDnegative pregnant women carrying an RhD-positive foetus.      And to assess the safety of Roledumab in RhD-negative pregnant women and in RhD-positive     foetus and newborns.      In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in     RhDnegative pregnant women carrying an RhD-positive foetus and the immunogenicity of     Roledumab will be assessed.   "
76241|NCT02287883|"     The investigators will study the delivery of care to patients with diabetes and     cardiovascular diseases from 16 practices in health care organizations who receive incentives     for improving the quality of patient care. Half of those will be far along in engaging     patients in their care and half will not. The investigators will see whether patients with     diabetes or cardiovascular diseases who receive care from practices that more fully involve     their patients have better clinical outcomes and satisfaction with their care than those who     do not. The investigators expect that these findings will help practices and patients to     achieve better outcomes of care.   "
76242|NCT02287870|"     Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a     short time, provides fast motor recovery and causes no significant side effects.   "
76243|NCT02287857|"     The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir     Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir     Disoproxil Fumarate Tablets of Gilead.   "
76244|NCT02287844|"     The purpose of the present study was to establish the prebiotic effect of a new     xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their     effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized,     parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly     assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an     equivalent weight of wheat maltodextrins (placebo) during 4 weeks.   "
76245|NCT02287831|"     The purpose of this study is to assess the safety and efficacy of umbilical cord mesenchymal     stem cells in diabetes with peripheral arterial disease.   "
76246|NCT02287818|"     AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed     potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism     of actions of AC-201 include the inhibition of the production and activity of caspase-1 and     interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in kidney. The     goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate     solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering     therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key     role in mediating this inflammatory response. The study is designed to test the     urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period,     followed by addition of an ULT to test the efficacy and safety of the combination and     prophylaxis of gout flares during ULT.   "
76247|NCT02287805|"     The purposes of this study are:        -  to better understand the experience of the announcement for the diagnostic of          craniosynostosis to patients and their families to improve the understanding of it and          it modes of appropriation        -  to compare the announcement process concerning simple and complex forms.        -  to identify the intra-family issues at the announcement of a genetic mutation.        -  to reconstruct the care course of patients by analyzing the time of the announcement and          the post-operative period.   "
76248|NCT02287792|"     The purpose of this study is to assess the impact of 18-FDG positron emission tomography     (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven     IE in detecting cardiac valve damages and other extracardiac complications. The study will     evaluate whether this procedure can change the clinical decisions (treatments, valve surgery,     patients' overall care) and modify the diagnosis of IE.   "
76249|NCT02287779|"     This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in     overweight and obese adults.   "
76250|NCT02287766|"     The objective of this study is to determine whether the finger tip images captured by the     EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale     that characterizes trends consistent with Metabolic Syndrome identified by medical doctors.   "
76251|NCT02287753|"     The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during     cardiac surgery to predict postoperative outcomes in pediatric patients.   "
76252|NCT02287740|"     Objective: To conduct a comparative efficacy and cost-effectiveness study of an     evidence-based fall prevention program—Tai Ji Quan: Moving for Better Balance (TJQMBB).   "
76253|NCT02287727|"     This phase II trial studies how well regorafenib works in reducing the return of disease in     patients with rectal cancer that has not spread to another place in the body who have     completed curative-intent treatment. Regorafenib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Regorafenib may also help keep cancer     from coming back after it has disappeared following the initial therapy.   "
76254|NCT02287714|"     Compare results of Instep Plantar Fascial release with and without gastrocnemius recession   "
76255|NCT02287701|"     The overarching goal of this project is to explore whether associations exist between metrics     obtained from PET/MRI incorporating advanced MRI sequences and features of bladder cancer,     including grade, stage, and treatment response.   "
76256|NCT02287688|"     This safety surveillance study of Novartis quadrivalent meningococcal ACWY conjugate vaccine     (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a     post-marketing study required by the United States Food and Drug Administration.      It is an observational study of children 2-23 months of age who receive at least one dose of     MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled     as a KPSC health plan member.      The objective of the infant study is to describe medical events that require emergency room     visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23     months of age in a health maintenance organization in the United States. Outcomes include     medical events that require emergency room visits or hospitalizations in children 2-23 months     of age following any dose of MenACWY-CRM vaccination. Events with a history of the same     diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a     pre-existing condition.   "
76257|NCT02287675|"     To compare the kinetics and efficacy of two functionally different diagnostic agents,     Lymphoseek (CD206 receptor targeted) and 99mTc-SC (Sulfur Colloid non-specific mapping agent)     in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).   "
76258|NCT02287662|"     The primary objective of this study is to determine the efficacy, safety and feasibility of     next day discharge hime in patients undergoing balloon-expandable transfemoral TAVR utilizing     the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.   "
76259|NCT02287649|"     Aims of the study : 1) To determine whether the presence of the V158 allele of Fc gammaRIIIA     gene is associated with a better outcome of Immune Thrombocytopenia (ITP) in adults and     especially with a higher response-rate to rituximab. 2) To analyze the impact of therapy and     especially rituximab on some B and T cells autoreactive subsets in the peripheral blood.      Patients and Methods :      Inclusion criteria : age ≥ 18 years, primary ITP defined according to the recent consensual     criteria (Rodeghiero F et al. Blood 2009), active ITP defined as an ITP with a platelet count     < 50 x 109/L requiring treatment, informed consent. Main exclusion criteria : secondary ITP.      Blood samples (serum, plasma, DNA) will be collected in every patient at time of inclusion     (pre-treatment) and then sequentially at 3, 6 and 12 months after inclusion in patients     treated with rituximab or during the remission phase for other treatments for immunological     studies. When a marrow analysis is indicated, some marrow specimens will also be collected     and studied and if a patient will have to undergo a splenectomy as a standard of care, some     spleen specimens will also be collected. Fc gamma RIIIA V/F158 polymorphism will be assessed     by means of an allele-specific PCR. The sequential analysis of anti-platelets     (anti-GpIIbIIIa) antibodies producing B cells will be performed by means of flow cytometry     and ELISPOT analysis. T cells subsets will be harvested in presence of GpIIbIIIa     immunodominant peptides and and cytokines expression will be measured on supernatants on days     2 and 11 in vitro by using Luminex technology in order to characterize and distinguish TH1,     TH2, TH17, TFH and Tregs subsets.      The primary outcome will be the overall response rate 1 year after inclusion defined by a     platelet count > 30 x 109/L with at least a two-fold increase of the initial (pre-treatment)     count. For the patients treated with rituximab as a standard of care, based on the overall     expected response-rate (40-50%) and based on preliminary data on FcgammaRIIIA V/F158     distribution, the inclusion of 85 patients should be sufficient to show an association of the     V158 allele and the response (b risk 20% and a 5%). Responders and non responders will be     compared by non parametrical tests, a multivariate analysis will be than performed using a     logistic regression model. The immunological data B and T cells subsets) obtained in both the     responders and the non responders will be compared over time (To, M3, M6 and M12) by non     parametrical matched tests.   "
76260|NCT02287636|"     This pilot clinical trial studies how well positron emission tomography (PET)/magnetic     resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger     patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET     scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the     same time with the same machine. The combined scans give more detailed pictures of areas     inside the body than either scan gives by itself. It is not yet known whether PET/MRI works     better than PET/CT in diagnosing younger patients with cancer.   "
76261|NCT02287623|"     The primary objective of this study is whether one local anesthetic, liposomal bupivacaine,     provides improved pain control and decreased opioid use compared to bupivacaine when injected     during a transversus abdominis plane block for donor nephrectomy patients.   "
76262|NCT02287610|"     The overall objective of the study is to assess the effectiveness of switching from     immediate-release prednisone (conventional) therapy to delayed-release prednisone (RAYOS) in     patients with moderately to severely active Rheumatoid Arthritis (RA), managed according to     standard of care in clinical practice settings.   "
76263|NCT02287597|"     This local, non-interventional, cohort study of patients with metastatic colorectal cancer     (mCRC) will prospectively collect data from standard clinical practice of second-line     treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional     diagnostic or therapeutic procedures required by this study, apart from those performed in     everyday clinical practice for second-line treatment of mCRC in Croatia.   "
76264|NCT02287584|"     The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with     placebo in patients with schizophrenia.   "
76265|NCT02287571|"     The aim of this prospective, randomized controlled trial is to compare the effects of     preoperative skin traction and position splint on pain, comfort, complications, difficulty     level of nursing interventions, satisfaction from treatment and nursing care in patients with     hip fracture. The sample is comprised of 34 patients with hip fracture in each group, totally     68 patients. Skin traction and position splint were applied after block randomization. Data     regarding pain, comfort, satisfaction from care, immobilization comfort, complications, time     of operation and hospitalization time were collected after intervention.   "
76266|NCT02287558|"     This study will evaluate patients > 18 years of age with transfusion-dependent     gastrointestinal bleeding due to documented gastrointestinal vascular ectasia with or without     concurrent hereditary hemorrhagic telangiectasia (HHT). This study will focus on documented     bleeding sites in the small bowel, including the duodenum, jejunum and ileum. Eligible     patients will have endoscopically-documented sites of vascular ectasia and will have required     at least 4 units of blood transfusion or episodes of intravenous iron administration over the     preceding four months.   "
76268|NCT02287532|"     The aim of the TELESAGE study is to demonstrate        1. the superiority of follow up with the DIABEO system (software alone) versus usual follow          up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a          basal-bolus insulin regimen.        2. the superiority of follow up with the DIABEO system (software + telemonitoring) compared          to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients          treated with a basal-bolus insulin regimen.      The DIABEO software alone is an electronic diary system incorporating an immediate automatic     aid to calculating the insulin dose according to the prescription given by the doctor, and a     data processing, automated analysis message and secure internet data transfer system.      The DIABEO software added by paramedical telemonitoring is the electronic diary combined with     remote paramedical monitoring of data (telemeonitoring)   "
76269|NCT02287519|"     This research study is evaluating an educational intervention for women who have experienced     changes in sexual function after treatment for ovarian cancer.   "
76270|NCT02287506|"     There are three main forms of diabetes: Type 1 diabetes, Type 2 diabetes and genetic     diabetes. The treatment for each is very different because they have different causes. People     with Type 1 diabetes stop making their own insulin, so need insulin injections instead,     whereas people with Type 2 diabetes can keep making their own insulin but it may not work as     well as it should, so they need to watch what they eat, and may also need tablets or     eventually insulin injections. Genetic forms of diabetes have specific treatments according     to the subgroup.      It is not easy for doctors to be able to say for definite what kind of diabetes a person has,     particularly in young adults, where the distinction between the types is less clear. Because     of this, sometimes (in about 10% of cases) people are given the wrong diagnosis. This can     have a huge impact as it means they could be on the wrong treatment from the start, so they     cannot control their blood sugars properly, which can lead to increased problems with their     health and poor quality of life.      We think we have a way of improving this situation. We have developed a tool called an     Optimised Diagnostic Strategy (ODS). This combines a person's clinical features (such as     their age and weight), with blood tests looking for changes in their body's immune (defence)     system, and a blood test looking for specific changes in their genetic code, to help     accurately diagnose what kind of diabetes that person has. We now need to test this ODS to     see if it is better at getting the right diagnosis and treatment from the start compared with     what we do in routine clinical practice at the moment. This kind of project is called a     Randomised Controlled Trial (RCT) and would involve patients from General Practitioner (GP)     surgeries all over the United Kingdom (UK). The project would be expensive as it involves a     lot of work by many people to get it set up and to keep it running. Before we can do this we     need to do a pilot to see if the bigger study would be possible and practical to do. This     pilot project will be done locally in Exeter and test all the parts needed for the larger     scale RCT.   "
76271|NCT02287493|"     In a prospective, non-interventional, monocentric observational study the pharmacokinetic     properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED)     will be analyzed.      Plasma specimens will be quantified using high Performance liquid chromatography (HPLC).      Primary endpoint: Plasma levels of antiinfectives during SLED      Secondary endpoints:        -  28-day-mortality        -  length of stay at the intensive care unit (ICU) and in hospital        -  clinical and microbiological cure of infections      Inclusion criteria:        -  age: > 18 years        -  patients under SLED        -  antiinfective treatment      exclusion criteria:      - missing informed consent   "
76272|NCT02287480|"     The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola     outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven     therapy or prevention available at this time.      The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in     preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in     large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials     are needed. To accelerate this process, the World Health Organization (WHO) has constituted a     consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use     similar protocols to collectively include roughly 250 volunteers, the sample size required to     identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization with 2     different doses of BPSC1001.      The joint primary objectives of this single-center, double-blind, randomized     placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of     the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine     dose and to define whether seroresponses differ significantly following immunization with the     lower or higher vaccine dose.   "
76273|NCT02287467|"     Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is     usually mild, but can cause serious illness or death. The purpose of this study is to test     the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune     immunoglobulin or IVIG) in people who are hospitalized for severe flu.   "
76289|NCT02287259|"     Determine the efficacy and tolerability of olanzapine for treatment of acute depression in     patients with bipolar II or bipolar disorder NOS compared with lithium.   "
76290|NCT02287246|"     To study post-operative efficacy of Exparel® for pain control in patients undergoing any     Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded     placebo controlled trial.   "
76274|NCT02287454|"     The study design was a parallel-group randomized trial with equal randomization. Recruitment     and enrollment were conducted between January 2013 and March 2013. At base-line, cognitive     data was collected. Afterwards, the participants were randomly allocated to either the     REHACOP group or the Control group. During 3 months the intervention with REHACOP program     took place and at follow-up patients were again re-evaluated to evaluate the change in     cognitive measure. Post-treatment assessment (finished by July 2013) was performed within the     first week after completing the intervention.      Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to     improve cognition of patients with Multiple Sclerosis (MS).   "
76275|NCT02287441|"     The objective of this study is to determine if differences exist in the total vegetable     intake of groups that eat either tomato products versus raw vegetable product.   "
76276|NCT02287428|"     This research study is studying a new type of vaccine as a possible treatment for patients     with MGMT-unmethylated glioblastoma. This research study is a Phase I clinical trial, which     tests the safety of an investigational intervention and also tries to define the appropriate     dose of the intervention to use for further studies. Investigational means that the     intervention is being studied and that research doctors are trying to find more about it. It     also means that the FDA (U.S. Food and Drug Administration) has not approved the Personalized     NeoAntigen Cancer Vaccine for any use in patients, including people with glioblastoma.      The purpose of this study is to determine if it is possible to make and administer safely a     vaccine against glioblastoma by using information gained from specific characteristics of the     participants tumor. It is known that glioblastomas have mutations (changes in genetic     material) that are specific to an individual patient's tumor. These mutations can cause the     tumor cells to produce proteins that appear very different from the body's own cells. It is     possible that these proteins used in a vaccine may induce strong immune responses, which may     help the body fight any tumor cells that could cause the glioblastoma to come back in the     future.   "
76278|NCT02287402|"     The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose)     0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to     diet therapy and exercise therapy, and follow up the progress after the end of treatment in     patients who was assessed as normoglycemic.   "
76279|NCT02287389|"     The purpose of this study is to evaluate the efficacy and safety of four interventional     pulmonology techniques for the treatment of fibrotic central airway stricture.      The four techniques are：        -  balloon dilation        -  balloon dilation plus cryotherapy        -  balloon dilation plus spiculiform electrosurgery        -  balloon dilation plus mitomycin C injection   "
76280|NCT02287376|"     Study Objectives:        1. The primary objective is to characterize the pharmacokinetics of a single oral          administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis          of episodic migraine with or without aura.        2. The secondary objectives are to determine:             1. The safety and tolerability of Cambia from a single dose             2. Three-month safety evaluation of Cambia in outpatient usage in this population   "
76281|NCT02287363|"     The study aims to analyze the genetic variance between thyrotoxic periodic paralysis (TPP)     patients and pure hyperthyroidism individuals. Meanwhile, the investigators also intended to     evaluate the morphological difference in effected skeletal muscles and investigate their     relation with genetic variance.   "
76282|NCT02287350|"     As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study     are to characterize the pharmacokinetic (PK) profile and to determine the safety and     tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to     moderate acute pain.   "
76283|NCT02287337|"     The purpose of this study is to see if a recently developed clinical prediction rule (CPR)     will successfully identify which patients with neck pain will respond rapidly and favorably     to manipulation of their cervical spine.   "
76284|NCT02287324|"     The purpose of the study is to see if manipulation of the neck will change the way people who     may or may not have neck pain, walk under differing conditions.   "
76285|NCT02287311|"     The subject has a type of lymph gland disease called Hodgkin Disease (HD) or non-Hodgkin     Lymphoma (NHL), T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus     (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment,     including the best treatment we know for these diseases. This research study uses special     immune system cells called LMP, BARF-1 and EBNA1- specific cytotoxic T lymphocytes (MABEL     CTLs).      Some patients with Lymphoma, T/NK-lymphoproliferative disease, or CAEBV show signs of a virus     called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (mono or the     kissing disease) before or at the time of their diagnosis. EBV is found in cancer cells of     up to half the patients with HD and NHL, suggesting that it may play a role in causing     Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV) infected by     EBV are able to hide from the body's immune system and escape destruction. We want to see if     special white blood cells (MABEL CTLs) that have been trained to kill EBV infected cells can     survive in your blood and affect the tumor.      In previous studies, EBV CTLs were generated from the blood of the patient, which was often     difficult if the patient had recently received chemotherapy. Also, it took up to 1-2 months     to make the cells, which is not practical when a patient needs treatment more urgently. To     address these issues, the T cells in the current study were made in the laboratory in a     simpler, faster, and safer way. The T cells we have made will still see LMP proteins but also     two other EBV proteins called EBNA-1 and BARF. These cells are called MABEL CTLs. In order to     ensure these cells are available for use in patients in urgent clinical need, we have     generated MABEL CTLs from the blood of healthy donors and created a bank of these cells,     which are frozen until ready for use. We have previously successfully used frozen T cells     from healthy donors to treat EBV lymphoma and virus infections and we now have improved our     production method to make it faster.      In this study, we want to find out if we can use banked MABEL CTLs to treat HD or NHL,     T/NK-lymphoproliferative disease and severe chronic active Epstein Barr Virus (CAEBV). We     will search the bank to find a MABEL CTL line that is a partial match with the subject.   "
76286|NCT02287298|"     We propose to undertake a retrospective review of approximately 200 patients with a diagnosis     of exudative macular degeneration treated with triple combination therapy (Bevacizumab,     Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina     Center and compare those results with an additional group of approximately 200 patients also     treated with triple combination therapy and 20 mg of daily oral zeaxanthin.   "
76287|NCT02287285|"     Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the     role of endogenous glucagon-like peptide-1 (GLP-1).   "
76288|NCT02287272|"     The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993     (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of     the organic cation transport in the kidneys), by comparing the systemic exposure (AUC0-t) of     Glycopyrronium Bromide (GB), after a single dose of the fixed combination CHF 5993 pMDI     administered alone or at steady-state of Cimetidine   "
76291|NCT02287233|"     This study consists of three portions: The first portion- Phase 1, or dose-escalation     portion, that will evaluate the safety and pharmacokinetic profile of venetoclax in     combination with low-dose cytarabine (LDC), define the maximum tolerated dose (MTD), and     generate data to support a recommended Phase 2 dose (RPTD) in treatment-naïve subjects with     Acute Myelogenous Leukemia (AML). Second portion, initial Phase 2 that will evaluate if the     RPTD has sufficient efficacy and acceptable toxicity to warrant further development of the     combination therapy. Subsequently, Phase 2 Cohort C, will evaluate the overall response rate     (ORR) for subjects allowed additional supportive medications (strong CYP3A inhibitors) if     medically indicated.   "
76292|NCT02287220|"     The purpose of this study is to test the accuracy of a web cam-based biomedical device     developed at UVA (not FDA-approved) that is designed to measure heart rate, respiratory rate,     and oxygen saturation without requiring any patient contact. One potential application of     such a device would be in the field of infant monitoring allowing parents (and physicians) to     monitor the vital signs of infants continuously. The investigators therefore propose to     record the heart rate, respiratory rate, and oxygen saturation of 100 infants (defined as     children aged 12 months or less) who are receiving continuous oxygen, heart rate, and     respiratory rate monitoring with a traditional vital signs monitor. The relationship between     non-contact and gold standard (GE monitoring equipment) heart rate, respiratory rate, and     oxygen saturation will be analyzed using regression and limits of agreement analysis.   "
76295|NCT02287181|"     A prospective, randomised, phase IV trial including 150 patients.      To evaluate the effects of varied concentrations of remifentanil on the proposal requirements     for the loss of consciousness and response to pain and to evaluate the haemodynamic changes     and processed EEG (BIS) during induction of anaesthesia.   "
76296|NCT02287168|"     Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through     peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have     preventive effect on positive peritoneal cytology occurred during gastrectomy in patients     with gastric cancer.   "
76297|NCT02287155|"     As in many other countries in the world, the population in Switzerland is growing older. This     also means an expansion of costs in the health system. Therefore, the investigators need to     find concepts of health promotion to prevent people from getting ill and dependent of the     health care system.      Our project aims at developing a health promotion program for persons over 50 years of age in     a rural area of Switzerland. The program's name is bliib gsund. This occupational-therapy     directed health promotion program is conducted over a period of six months in two groups of     eight persons each. The aim of the program is to enhance the quality of life of the     participants, to mediate the competence of integrating health-promoting aspects in their     daily life, and to maintain their independence in their life as long as possible. Persons     over 50 often find themselves in a phase of transition in life, such as starting retirement,     the loss of family members or children moving out. This program will provide them with the     ability to continue their lifestyle in a more active way. It embraces topics such as more     active pursuits of interests and carrying out personally meaningful activities.      In preparation of the program, the investigators conducted a needs analysis to identify the     needs relating to health-promoting offers of the inhabitants living in the specified region.     The results showed a high interest and need for such programs. They also helped us to     identify several relevant issues to be included in the presented health-promotion program:     physical exercise in daily life, healthy nutrition, getting acquainted with new technologies,     fall-prevention training and maintaining social contacts. The researchers and the designated     occupational therapist, who will be the moderator of the program, can develop the program     based on these results.      The evaluation of the program should identify the effect of the program concerning the     promotion of self-efficacy, the sense of coherence, quality of life and the program     objectives. A questionnaire will be distributed before the program, immediately after and six     months after the program.   "
76298|NCT02287142|"     The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block,     suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder     arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all     three arms will receive equal analgesia since these blocks are routinely performed to treat     post-operative pain after shoulder surgery.   "
76299|NCT02287129|"     Metabolic and Molecular Response evaluation for the individualization of therapy in     adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for     patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally     advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Additonal     efforts will be done by investigation of molecular and metabolic biomarkers in relation to     their predictive and prognostic value by correlating them with histopathologic responses and     clinical outcome in an exploratory approach.   "
76300|NCT02287116|"     The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP     (nasal continuous positive airway pressure)as the initial respiratory support when using     minimal ly invasive surfactant therapy (MIST) in preterm infants.   "
76301|NCT02287103|"     Background: Skipping breakfast and/or overeating at evening, has been associated in type 2     diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased     overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also     associated with increased plasma free fatty acids (FFA) along the morning until lunch. High     plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin     mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize     that compared to eating breakfast the prolonged overnight fasting caused by the breakfast     omission will result in increased postprandial glycemic response after subsequent isocaloric     lunch and dinner in T2D individuals.      Objectives: With this aim will study T2D patients in randomized crossover design to consume     in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or     omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same     caloric content.      Methods and Study Design: The YesB intervention will consist on three identical meals coating     700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention     the breakfast will be omitted and the subject continue fasting until lunch. Then the     participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00.     The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood     samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the     same time point the blood samples will be collected after 8:00 when the breakfast will be     omitted.      Expected results: The investigators expect that compared to NoB condition, in the YesB     condition the postprandial response after lunch and dinner will be reduced for glucose and     for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and     dinner will be enhanced   "
76302|NCT02287090|"     Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based     guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking.     Our proposed study aims to fill these gaps by identifying the prognostic factors which will     predict better outcomes of rotator cuff tears, based on both operative and non-operative     treatment. The investigators will also compare outcomes of operative and non-operative     treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.   "
76303|NCT02287077|"     The objective of this pilot study is to investigate the feasibility of performing umbilical     cord milking in neonates who are depressed at birth.   "
86861|NCT02149108|"     The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients     with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard     chemotherapy and biological agents.   "
76315|NCT02286921|"     Asymptomatic men with progressive metastatic CRPC post- treatment with abiraterone acetate     (pre-chemotherapy for metastatic disease) will be treated on a randomized,     multi-Institutional open label study to determine if treatment with intramuscular T given on     a dose/schedule designed to result in rapid cycling from the polar extremes of     supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve     primary and secondary objectives vs. enzalutamide as standard therapy.   "
76316|NCT02286908|"     The aim of the study is to investigate if global strain and mechanical dispersion may predict     death and ventricular arrhythmias better than ejection fraction(EF) in patients with     myocardial infarction and heart failure regardless of cause.   "
76317|NCT02286895|"     This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV)     after a fourth dose is given at 9 months of age with local WHO Expanded Programme on     Immunization (EPI) vaccines in Mali.   "
76318|NCT02286882|"     PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single     oral doses of PF-06409577 in healthy adult subjects.   "
76319|NCT02286869|"     This study measures the cardioventilatory coupling in critically ill patients during     mechanical ventilation in controlled mode (pressure controlled) and in patient-driven mode     (pressure support and neurally adjusted ventilatory assist).   "
76305|NCT02287051|"     Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure     depends on an adequate visualization of the mucosa of the colon.There is strong evidence that     the quality of bowel preparation is inversely correlated with the interval between the end of     the assumption of the purgative and the start of colonoscopy (shorter intervals are     associated with higher levels of preparation).Recent studies have shown that split dose prep     significantly improves the quality of bowel cleansing. In light of these data, both the     American College of Gastroenterology (ACG) and the European Society of Gastrointestinal     Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel     cleansing. Despite these recommendations, the uptake of schemes in divided doses appears     clearly underused in actual clinical practice. In particular, in Italy only a few centers     routinely adopt the regime split as their first choice for the preparation for     colonoscopy.The reasons why the split dose is under-utilized in clinical practice are not     entirely clear, but probably in part reflecting gastroenterologists' concerns about potential     elements that theoretically could make it less acceptable to the patient (get up early in the     morning, potential problems during the journey from home to the hospital) The hypothesis of     the study is that many patients would still be willing to accept these potential drawbacks if     they were adequately informed about the positive impact of the scheme in divided doses on the     effectiveness of bowel preparation, which results in higher reliability of the examination,     shorter duration of the procedure, and less risk of rescheduling the exam in the near future   "
76306|NCT02287038|"     The current available treatments for PTSD are not fully effective for cognitive symptoms of     PTSD and have high drop-out and poor engagement, two factors found to be most indicative of     overall return to functioning for patients with PTSD. Successful completion of this pilot     clinical trial may build a platform for future large scale double-blind, placebo-controlled     studies using either atomoxetine or psycho-stimulants or other cognitive enhancing     medications. The response inhibition related measurements are sensitive to psychotropic     medications. Therefore it is advantageous for us to use GNG and Stop Signal approaches to     investigate individual treatments response in the investigators' future research. The     investigators believe GNG and Stop signal approaches together with pharmacogenetic approach     will provide valuable information to direct future individualized medicine.   "
76307|NCT02287025|"     Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff)     support and education on treatment discontinuation rates in the absence of progression in     patients with metastatic colorectal cancer treated with regorafenib. Intensified education     and support will be provided through an application for iPad which has automatic links to     grading, dose reduction and side effect management ,as well as, references for additional     articles.   "
76308|NCT02287012|"     This study aims to observe the effects of the availability of plerixafor on the time and     effort associated with autologous peripheral blood stem cell collection.   "
76309|NCT02286999|"     The purpose of this study is to investigate the dose of a probiotic supplement     (Bifidobacterium longum subsp. infantis) required to achieve predominant gut colonization in     healthy newborn, breastfed infants. The study will also examine whether supplementation with     this probiotic can reduce the chance of developing eczema and food allergies in enrolled     infants.   "
76310|NCT02286986|"     Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P     compared with placebo with respect to:        -  Incidence, type and severity of adverse events (AEs)        -  Effect on vital signs, including weight        -  Effect on 12-lead electrocardiogram (ECG) findings        -  Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic          efficacy of GWP42003-P compared with placebo with respect to the incidence in convulsive          seizures        -  To determine the plasma concentration time curves for GWP42003-P and its major human          metabolite, following escalating multiple doses of GWP42003-P.        -  To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant          anti-epileptic drugs (AEDs).        -  To evaluate cognitive function, sleep quality and daytime sleepiness, in patients taking          GWP42003-P in combination with AEDs.   "
76311|NCT02286973|"     This prospective randomized controlled trial was conducted To compare the efficacy of TNA in     terms of total blood loss and the allogenic transfusion rate among the three study groups;     intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and     high dose topical TNA.      To evaluate the safety of each regimen in view of deep vein thrombosis and venous     thromboembolism.   "
76367|NCT02286245|"     Telephone medical advice in general practice is expanding. The Cochrane Database concludes in     2008 that there is not enough data about its use regarding out-of-hours general practitioners     workload, emergency department visits, cost, safety and patient satisfaction. The aim of this     study is to assess the effectiveness of telephone medical advice given by a general     practitioner in a call centre for patient presenting isolated fever or gastroenteritis     symptoms.   "
76312|NCT02286960|"     Despite the considerable use of oral steroids in the regular management of benign vocal fold     lesions there is little evidence base in the literature. This study will investigate the     efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. The     specific aim of this study is to determine the effectiveness of of a short course of oral     steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold     lesions. Enrolled subjects will be randomized using a random numbers table to either receive     oral steroids or no steroids prior to the initiation of voice therapy. The therapist and     individuals involved in the collection and analysis of data will be blinded as to whether the     subject received drug. Prior to initiation of therapy subjects will be asked to return for an     interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects     will enter then the voice therapy phase . After an initial evaluation to determine the best     mode of therapy they will receive a behavioral voice therapy course, which includes a range     of behavioral modifications and motor learning techniques, along with lifestyle measures. In     all these phases acoustic and aerodynamic measurements will be collected as well as     audio-visual material from the videostroboscopic exams. The investigators hypothesize that     oral steroids will lead to a reduction in lesion size, which will substantially aid in the     delivery and incorporation of voice therapy techniques, contributing to the improvement of     overall laryngeal biomechanics and providing an ideal starting point for behavioral voice     therapy.   "
76313|NCT02286947|"     The primary objective of this study is to explore safety and tolerability of eteplirsen in     patients with advanced stage Duchenne muscular dystrophy (DMD) who are amenable to exon 51     skipping. The exploratory objectives are to evaluate the effect of eteplirsen on pulmonary     function tests (PFTs) and other functional clinical measures.   "
76314|NCT02286934|"     A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on     Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol   "
76320|NCT02286856|"     The m.3243A>G mutation is the most frequent cause of mitochondrial disease in adults, for     which currently no therapy is available and treatment is solely supportive. Since both     malnutrition and obesity are frequently seen in these patients, an adequate nutritional     intervention to improve body composition and function might improve the quality of life of     these patients.      Hypothesis / research questions Hypothesis part 1: Patients with mitochondrial disorders     caused by the m.3243 A>G mutation have an increased risk for malnutrition.      Hypothesis part 2 : Intervention study: Dietary intervention in adults with a mitochondrial     disorder caused by the m.3243 A>G mutation has a positive effect on nutritional status,     activity, hand grip strength, body composition, food intake, fatigue and quality of life.   "
76321|NCT02286843|"     Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2     (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2,     which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients     also benefit from medicines that attack HER2, but we do not know why or which patients will     benefit. This study uses a new imaging method, 89Zr-trastuzumab PET/CT, to identify patients     that may benefit from medicines that attack HER2. This is experimental.   "
76322|NCT02286830|"     Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until     progression in bone disease compared to patients who stop treatment after two years?      Secondary hypothesis: Serum will bone markers increase prior to progression in bone disease     in the individual patient?      Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in     Multiple Myeloma compared to conventional radiography   "
76323|NCT02286817|"     This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting     genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study are     to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral     administration of NFC-1 and to evaluate safety and tolerability and to obtain evidence for     the effect of NFC-1 on ADHD severity and global functioning during and following four weeks     of continuous treatment. Exploratory analyses will be performed to assess effect size of     specific mGluR-network genes on ADHD based on responsiveness of patients to NFC-1. This study     will be conducted at a single clinical site, the Jefferson University Hospital PKU     (Philadelphia, PA).   "
76324|NCT02286804|"     Up to 30 enrolled subjects will be treated. Enrolled subjects will receive Ultherapy®     treatments along each length of the spider vein. Follow-up visits will occur at 30 and 60     days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment,     and at each follow-up visit.   "
76325|NCT02286791|"     The objective of this study is to determine whether regular Mindful Awareness Program (MAP)     may reverse cognitive impairment and/or prevent further cognitive decline among older adults.     60 elderly with mild cognitive impairment (MCI) were randomized to participate in either the     MAP or the Health Education Program (HEP). Sessions will be conducted weekly for 12 weeks,     and monthly for 6 months. Participants would be assessed at 3 time-points: at the start, at     3-months and at 9-months.      It was hypothesized that as compared to HEP participants, MAP participants will (1) have     improved functional connectivity, (2) have a decreased risk in cognitive decline and (3)     report higher psychological well-being.   "
76326|NCT02286778|"     The purpose of this study is to confirm the findings of an early study and expand our     knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP     (Adenosine-5'-Triphosphate) Inhibitor.   "
76327|NCT02286765|"     Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on     the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days     following the last treatment.      Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.   "
76365|NCT02286271|"     Official statistics report around 1000 deaths due to epilepsy in the UK each year (Hanna et     al 2002). Most of these deaths are un-witnessed and in many cases are believed to have been     avoidable with timely assistance (Langan et al 2000). A major problem is detecting nocturnal     seizures to allow body re-positioning, to maintain an open airway and to administer rescue     medication. There are several seizure alarms commercially available but are often unreliable     with many false alarms. The aim of this study is to investigate a novel seizure detection     system with a unique algorithm.   "
76328|NCT02286752|"     Postoperative nausea and vomiting is one of most common complications after general     anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non     smoker status, opioid administration are known as risk factors for developing postoperative     nausea and vomiting.      It has been suggest that antagonism of residual neuromuscular block with a mixture of     neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea     and vomiting.      Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse     effects include slight coughing, movement, an altered taste sensation in the mouth, transient     prolongation of the QT interval, hypersensitivity, and a short term prolongation of the     activated partial thromboplastin time.      The aim of this study was to compare the sugammadex versus neostigmine plus atropine for     reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative     nausea and vomiting.   "
76329|NCT02286739|"     The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist     the surgeon with tibiofemoral rotational alignment by testing the precision and variability     of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients     with a combined axial rotation couple at the tibiofemoral joint and quantitative     intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative     knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to     measure post-operative alignment and to evaluate the prevalence and location of radiolucency     and/or osteolysis.   "
76330|NCT02286726|"     The goal of this clinical research study is to compare different dose levels of CPX-351. The     safety and efficacy of the drug will be studied in all dose levels.   "
76331|NCT02286713|"     Educational research study where goal is to test educational materials that help people make     informed decisions about lung cancer screening.   "
76332|NCT02286700|"     The purpose of this study is to compare the effects of an amino acid moisturizing cream and     desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to     moderate atopic dermatitis/eczema.   "
76333|NCT02286687|"     The goal of this clinical research study is to learn if talazoparib can help to control     advanced cancer in patients who have a specific type of alteration (a type of genetic     change). The safety of this drug will also be studied.   "
76663|NCT02282475|"     Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be     associated with adverse maternal and fetal pregnancy outcomes. This study will examine how     fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to     metabolize glucose (sugar) during pregnancy.   "
76334|NCT02286674|"     Anxiety in children undergoing surgery is a central concern to both parents and healthcare     workers, including nurses, surgeons, and anesthesiologists. It has been ranked by     anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1).     This study would determine whether such devices would decrease anxiety in children prior to     induction of anesthesia for outpatient surgery. Two hundred children ages 2-12 will be     enrolled.   "
76335|NCT02286661|"     Distal radius fracture (DRF) is among the most common fractures of the long bones, which     comprise one sixth of all fractures. Due to its high prevalence, effect on patients' everyday     life, and cost on national health resources, its proper management is very important. The     investigators performed this prospective randomized clinical trial on 100 patients with DRFs.     50 patients were treated in each group either by short or long arm cast. Patients were     visited during the 6th and 18th weeks after the reduction regarding loss of reduction and     possible complications.   "
76336|NCT02286648|"     The purpose of this study is to evaluate the clinical and radiographic success rate of     Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.   "
76337|NCT02286635|"     The primary objective of the study is to determine the potential effects of multiple doses of     rifampin and clarithromycin on the single dose pharmacokinetics (PK) of the deflazacort     active metabolite (21 desacetyl-DFZ) in healthy adult subjects.   "
76338|NCT02286622|"     This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ     and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched     control subjects (age, body mass index [BMI], and gender).   "
76339|NCT02286609|"     This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ     and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on     the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age,     body mass index [BMI], and gender).   "
76340|NCT02286596|"     Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold     raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery     disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved     to be a reliable method to decrease LDL-C concentrations and therefore decrease     cardiovascular disease risk in HoFH. The objective of this crossover study was to compare     efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran     sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and     LDL particles size in a cohort of HoFH subjects.   "
76341|NCT02286583|"     Medical Radiometer depends on detecting the microwaves that radiates from deep structure hot     objects in the body. When it comes to the breast, causes of deep structure hot spots are     numerous, it can be inflammatory, hormonal or neoplastic. Therefore, the primary objective of     this study is to test the sensitivity of the Medical Radiometer in detecting the hot spots in     the breast.   "
76342|NCT02286570|"     Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face     intubation in an entrapped patient is one of these situations. The investigators want to     compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face     intubation in adult patients aged between 18-60 years.   "
76366|NCT02286258|"     The purpose of this study is to validate in comparison to a reference method (inuline) two     novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in     chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.   "
77652|NCT02269449|"     The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath     (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath     (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).   "
76343|NCT02286557|"     Up to 95% of individuals with Multiple Sclerosis report experiencing cognitive fatigue,     characterized by a lack of energy, feelings of exhaustion, an the perception that one is     unable to partake in daily activities. The goal of this project is to test whether     methylphenidate (MP), a well-known psychostimulant, can effective treat fatigue experienced     by individuals with MS.      The current study will test the effect of MP on MS fatigue through a clinical trial. Every     participant in the study will be exposed to both the drug and the placebo for a period of     time. Both the investigators and participants will be unaware whether participants are     receiving the drug or the placebo.      Upon successful completion of the study, physicians will be able to evaluate the potential     prescription of MP to treat fatigue in persons with MS based on solid research evidence.     Importantly, MP is already an FDA approved widely used medication in multiple clinical     populations.   "
76344|NCT02286544|"     Oxygen treatment is widely used in acutely ill patients. In particular, oxygen treatment is     routinely used in acute coronary syndrome (ACS) patients with suspected acute myocardial     infarction and variably recommended in ACS-guidelines, despite very limited data supporting a     beneficial effect.      Immediate re-opening of the acutely occluded infarct-related bloodvessel via primary     percutaneous coronary intervention (PCI) is the treatment of choice to limit ischemic injury     in the setting of ST-elevation ACS (STE-ACS). However, the sudden re-initiation of blood flow     achieved with primary PCI can give rise to further damage, so-called reperfusion injury.     Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of     pathological processes. Vascular leakage, activation of cell death programs, transcriptional     reprogramming, no reflow phenomenon and innate and adaptive immune activation all contribute     to tissue damage, thereby determining the infarct size. The effect of oxygen treatment on     these pathological processes, on the extent of IR-injury and the final infarct size in     STE-ACS patients has not previously been studied.      ACS is characterized by a systemic inflammation with typical elevations of soluble     inflammatory markers as well as changes in white blood cells. The inflammatory reaction might     be considered helpful in restoring myocardial tissue structure and function, but on the other     hand it might worsen IR-injury by activating various pathological processes. In human     experimental studies, Salmonella typhi vaccine has been used to create a standardized model     of systemic inflammation and when administered to healthy volunteers the vaccination has not     been associated with any adverse events.      In an ongoing register randomized multicentre clinical trial, the DETO2X (Determination of     role of oxygen in suspected acute myocardial infarction) study, the effect of oxygen on     morbidity and mortality in ACS patients is being investigated. In a substudy of the     DETO2X-trial, the investigators have planned to evaluate the effect of oxygen treatment on     IR-injury in STE-ACS as assessed by biomarkers reflecting various aspects of the pathological     processes involved.      The presented study is an experimental pilot study performed in healthy volunteers with a     Salmonella typhi vaccine-induced inflammation with the purpose of studying effects of oxygen     treatment on biological systems involved in the pathogenesis of IR- injury.   "
76345|NCT02286531|"     Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II     (referring to the current diagnostic gold standard represented by the histopathology exam of     a tumor sample).   "
76346|NCT02286518|"     The purpose of this study is to evaluate the safety and tolerability of TAK-114 following     single and multiple ascending oral doses in healthy Japanese male participants.   "
76358|NCT02286362|"     This non-interventional prospective study will assess the safety of Herceptin SC     (subcutaneous administration) as used in routine clinical practice. Patients with     HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be     treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with     Herceptin SC in routine clinical practice use are eligible to participate. The total study     duration is anticipated to be 38 months.   "
76347|NCT02286505|"     Early dementia diagnosis improves patient and carer experience, links them to appropriate     care and support and enables timely symptomatic treatment. The guidelines of the UK National     Institute for Health and Care Excellence recommend brain Magnetic resonance imaging (MRI) to     assist with the diagnosis in suspected dementia. Recently, computerised analysis of MRI     scans, also known as automated brain morphometry, has shown potential to detect the brain     changes characteristic of early dementia, and may therefore be a useful addition to the     standard reporting performed by a neuroradiologist. The present pilot study will assess     whether adding brain morphometric analysis to the usual diagnostic pathway improve diagnosis     in clinical practice as an addition to the existing diagnostic pathway in a memory clinic     setting. The main purpose of the study is to compare measures of the clinicians diagnostic     confidence in patients with and without brain morphometry.   "
76348|NCT02286492|"     The objective of the program is to provide access to TAS-102 to patients with metastatic     colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy     with TAS-102 and in whom therapy with TAS-102 is clinically indicated.   "
76349|NCT02286479|"     Skin abscesses are among the most common soft tissue infections cause emergency room visits     frequently. Management of abscess drainage and prevent further complications are important     entities for emergency physicians. Historically primary incision and drainage (I&D) technique     has found very effective method of abscess drainage, however a novel technique loop drainage     holds promising. The purpose of our study is comparison efficacy of I&D and loop drainage     techniques in patients with cutaneous abscess.   "
76350|NCT02286466|"     The proposed study seeks to implement a randomized controlled trial to evaluate the     effectiveness and generalizability of an efficacious cognitive-behavioral therapy (CBT)     intervention for use as a self-administered mobile application (mobile app) to treat anxiety     in patients with metastatic cancer.   "
76351|NCT02286453|"     Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee     Compared with Diclofenac. This study was designed as double blind, randomized controlled     trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat     University (No: 1 Faculty of Medicine)   "
76352|NCT02286440|"     The overall goal of this investigator-initiated trial is to evaluate the impact of platform     algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic     (PD) genomic variation on treatment outcome of depression in adolescents. This new technology     may have the potential to optimize treatment selection by improving response, minimizing     unfavorable adverse events / side effects and increasing treatment adherence   "
76353|NCT02286427|"     Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain,     superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous     cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but     clinical experience suggests that most epidermise in less than a month. Some, however, for     unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined     for this study as lasting more than three months are a source of major discomfort and could     play a decisive role in the morbidity and mortality of the disease.      The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of     chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3)     from the start of treatment.   "
76354|NCT02286414|"     The aim of the study is to compare, in real life, the risk benefit (including both major     bleeding and thrombotic events (TE) and death from any cause) associated with direct oral     anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering     from non valvular atrial fibrillation and living in community or nursing home settings.      An observational multicenter prospective inception cohort will be conducted within the     PRESAGE-Network, an ongoing active network on drug safety in older adults in the Ile de     France (IDF) area (Paris and its surroundings) involving a sample of general practitioners     (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and     pharmacists will prospectively include all octo+ patients they care for, newly treated with     an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years.   "
76355|NCT02286401|"     The purpose of this pilot study proposal is to test the ability of Transluminal Flow Encoding     (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for     invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for     suspected coronary disease.   "
76356|NCT02286388|"     This clinical trial is a national multicenter randomized controlled trial performed in     parallel groups aiming to validate a treatment that preserves pulp vitality of mature     permanent posterior teeth through partial removal of carious tissue and restoring tooth     structure using a simple filling in one session, thus delaying premature tooth aging.      Two successive randomizations will be performed (allocation ratio 1:1); firstly for the type     of excavation carried out (partial vs. complete caries removal) and secondly for the nature     of the adhesive used (antibacterial adhesive vs. non-antibacterial adhesive). The second     randomization will not be carried out for teeth requiring endodontic treatment after the     first randomization.      The study's primary objective will be to compare, at 1 year of follow-up, the efficacy     (binary success criteria) of partial caries removal versus complete caries removal in     occlusal or proximal deep lesions of mature permanent posterior teeth (bicuspids and molars     except third molars). Secondary objectives will include the comparison, at 1 year of     follow-up, of the efficacy (binary success criteria) of an antibacterial two-step self-etch     adhesive versus a traditional non-antibacterial two-step self-etch adhesive. Another     secondary objective will be to compare, at two and three years of follow-up, the efficacy of     partial versus complete caries removal.      The primary outcome is the success of the caries removal protocol at one year, measured     according to 5 FDI criteria, while the secondary outcome is the contribution of the     functional and biological dimensions of the 5 FDI criteria items to determining success or     failure of the treatment. The outcome of success will be the same for all objectives, primary     and secondary.   "
76357|NCT02286375|"     This paper aims to describe the research protocol that will be used to determine the     effectiveness of a health-social partnership intervention programme among community-dwelling     older adults   "
76664|NCT02282462|"     A 2 x 2 randomized study testing active versus passive drainage and regulated versus     unregulated pleural pressure in patients undergoing anatomic lung resection   "
76359|NCT02286349|"     This study aims to evaluate the effect of noninvasive brain stimulation in adults with ADHD     symptomatology compared them with healthy adults. For this, volunteers will allocate into two     groups (experimental and control), will pass through session two types of transcranial     stimulation: Repetitive Transcranial MagneticsStimulation (rTMS) and transcranial direct     current stimulation (tDCS); considering two session types (real and sham). Attentional     assessment will be carried out through specific neurocognitive tests applied before and after     each session of stimulation   "
76360|NCT02286336|"     The aim of this study is to determine the minimum effective concentration of local anesthetic     (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for surgical     anesthesia in 90% of patients (MEC90) in young group (18-40 years) and in middle aged group     (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the     shoulder.   "
76361|NCT02286323|"     We hypothesized that the BONFILS is beneficial for intubation of manikins while performing     CPR. In the current study we compared the performance of the BONFILS and the Macintosh     laryngoscopes with respect to their effectiveness and time to successful ETI during chest     compression (CC) using an adult manikin.   "
76362|NCT02286310|"     The aim of this study is to investigate the effect of exercise program on 3-dimensional     scapular kinematics, disability and pain on shoulder impingement with scapular dyskinesia.   "
76363|NCT02286297|"     Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining     a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines     emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR).     These guidelines also suggest that skilled operators should be able to secure the airway     without interrupting chest compression. The aim of the study was to compare time and success     rates of different available video laryngoscopes and the Miller laryngoscope for emergency     intubation during simulated pediatric CPR.   "
76364|NCT02286284|"     Introduction Preeclampsia is a multifactorial disease that is responsible of important     adverse maternal and perinatal outcomes. Recently, it has been suggested that soluble     fms-like tyrosine kinase 1, s-Flt1, induces preeclampsia-like phenotype in experimental     models and circulates at elevated levels in human preeclampsia.      The aim of our study is to see whether removal of s-Flt1 may improve perinatal death in women     with very early severe preeclampsia at less than 26 weeks' gestation Patients and methods     Phase II trial. Women with singleton pregnancy having severe preeclampsia at 23-256/7 weeks'     gestation. Women under 18 years, with multiples, or severe fetal growth restriction (less     than 5th centile), or abnormal fetal heart rate, or maternal complications (abruption,     eclampsia, HELLP syndrome, pulmonary edema, DIC, liver hematoma) are excluded from the study.     After blood pressure and maternal stabilization, women are approached for information and if     they agree, to sign the trial consent.      Women have twice weekly extracorporeal removal of s-Flt1 until 34 weeks' gestation.      Primary endpoint or success of the procedure: baby alive or alive at 6 months if hospitalized     Statistical procedure Simon minimax plan; P0: 60%, P1, 90%, alpha error: 5%, beta power; 90%.     First step: number 8 patients. If success equal or less than 5, the study is stopped.      Second step: if success of 6 or more, the study is continued for 9 more patients.      Overall, a maximum of 17 patients will be included. The final success of extracorporeal     removal of s-Flt1 will be considered if 14 or more babies will be alive or alive at 6 months     if hospitalized.   "
76368|NCT02286232|"     Chronic low back pain is a common condition that can negatively impact quality of life and     that lacks highly effective treatment options. The YMCA developed different iterations of a     stretching exercise program as a community based treatment for low back pain from 1974-2004.     Though anecdotally successful, the YMCA stretching exercise program(s) was not scientifically     evaluated for efficacy and became obsolete. The purpose of the study is to test the efficacy     of a previously popular YMCA stretching exercise program(s) for back pain. The stretching     exercise program that will be studied is a collection of all the resources available for the     YMCA stretching exercise program(s). The most recent criteria from a National Institutes of     Health sponsored Task Force to study chronic low back pain were applied to this study.   "
76369|NCT02286219|"     To evaluate the safety, tolerability, dose limiting toxicity (DLT), and maximum tolerated     dose (MTD), of FS102(BMS-986186) when administered intravenously (IV) to subjects with     relapsed or refractory solid tumors that overexpress HER2 and who have no standard treatment     options.   "
76370|NCT02286206|"     The objectives of this 15-day study are:        1. To compare steady-state trough plasma concentrations of clozapine and its metabolite          norclozapine when given once daily and twice daily (at the same total daily dose)        2. To determine if frequency of clozapine administration has an effect on:             1. Symptoms of schizophrenia             2. Adverse effects of clozapine             3. Fasting blood glucose, lipids, creatinine, and urea             4. Weight and waist circumference   "
76371|NCT02286193|"     This project will engage patients and health care teams to develop, implement, and rigorously     evaluate a new lay health worker role (Community Resource Specialist, CRS) for primary care     teams. The CRS will link patients and healthcare clinics with community resources.   "
76372|NCT02286180|"     Background and objectives:      Recently the news of intern doctors' death due to overloaded work or committing suicide has     made the authorities concerned put emphasis on the mental health care of medical staffs and     related policies of psychological interventions. The prefrontal lobe plays an important role     in the working memory, executive function and problem-solving abilities of the brain.     Currently, no neuroimaging studies investigating the impact of job stress on the prefrontal     love functions in intern doctors. Functional near-infrared spectroscopy (fNIRS) measures the     cortical functions of the frontotemporal regions and has been widely used as a biomarker to     aid in differential diagnoses in major psychiatric illnesses in Japan. The present study will     investigate impact of the job stress on brain cortical activity during a verbal fluency test     (VFT) by using fNIRS.      Materials and methods:      A total of 100 participants will be recruited. Clinical measurements of mood status by Beck's     Depression Inventory and Beck's Anxiety Inventory, as well as job stress by Chinese Version     of the Job Content Questionnaire and the Chinese version of Copenhagen Burnout Inventory will     be arranged. The relationship between clinical measurements and cortical activity during a     VFT will be analyzed by Pearson's correlation. Multiple regression analysis will be applied     to investigate the independent contributions of mood status and job stress.      Expected results and contributions of the study:      Job stress, depression, and anxiety are significantly negatively correlated with cortical     activity of prefrontal regions. The importance of mental health of medical staffs under high     job stress should be stressed.   "
76373|NCT02286167|"     The primary goal of this study is to assess the feasibility and biologic activity of a     modified Atkins-based diet combined with short-term intermittent fasting, a GLioma     Atkins-based Diet (GLAD), in patients with central nervous system GBM.   "
76374|NCT02286154|"     The primary objectives of this prospective study of hydroxyurea for children with sickle cell     anemia are 1) Develop and prospectively evaluate a population     pharmacokinetic/pharmacodynamics model to predict the maximum tolerated dose (MTD); 2)     Identify urine biomarkers of hydroxyurea adherence using a novel metabolomics approach; 3)     Identify pharmacogenomics modifiers of hydroxyurea MTD; and 4) Longitudinal monitoring of the     effect of hydroxyurea upon organ function and quality of life.   "
76375|NCT02286141|"     Back pain is one of the most common, controversial and costly problems in healthcare. Despite     numerous studies, care for back pain has deteriorated over time and become much more     expensive. The risk stratification approach developed in England and found effective in     National Health Service general practices in the UK provides a very promising strategy for     improving care for back pain in the U.S.      The MATCH trial will use a cluster randomization design involving 6 primary care clinics at     Group Health. Of these 6 clinics, 3 will be randomized to receive Group Health's standard     training in the use of Group Health back pain guidelines and 3 clinics will receive this     standard training plus supplemental training. Primary care clinicians and physical therapists     in the intervention group will receive training in the use of the STarTBack risk     stratification strategy for matching the most appropriate evidence-based treatments to the     needs of patients in each risk level. We will evaluate the effect of this supplemental     training on patient outcomes, clinician and physical therapist knowledge and comfort treating     patients with back pain, and utilization of services for back pain.   "
76376|NCT02286128|"     This study determines whether NF-кB dependent proinflammatory state found in type 2 diabetes     yield to a higher RAGE activation in the mesenchymal stem cell, as well as the effects of the     proinflammation on osteoblast differentiation impairment and cellular apoptosis in type 2     diabetic patients. This study will compare non-diabetic control subjects and type 2 diabetic     patients with metformin monotherapy failure in the aspect of 1) serum markers for NF-кB     dependent proinflammatory state and its intracellular signals, 2) osteogenic differentiation     and apoptosis of the mesenchymal stem cells, and 3) serum AGE, RAGE and cellular RAGE     activation.   "
76377|NCT02286115|"     The goal of this study is to test the efficacy, feasibility, and acceptability of providing     an experiential assessment interview that targets health, and emotional and stressful     experiences in a tertiary care setting specializing in women's urology.   "
76378|NCT02286102|"     The examination of the ability of the OrthoPAT® blood collection device to decrease the     transfusion rate and volume of adults undergoing posterior spine surgery for deformity     correction of 6 levels or more.   "
76379|NCT02286089|"     The main objective of the study is evaluation of the safety and tolerability of OpRegen -     human embryonic stem cell-derived retinal pigment epithelial (RPE)cells. The study will also     include initial exploration of the ability of transplanted OpRegen cells to engraft, survive,     and moderate disease progression.   "
76380|NCT02286076|"     To compare changes in follicular ovarian reserve in women before and six months after     laparoscopic operation: endometrioma stripping surgery. Also, to compare follicular ovarian     reserve in women with endometrioma(s) with follicular ovarian reserve of healthy infertile     women of the same age group.   "
76381|NCT02286063|"     The main aim of this project is to establish whether ambulatory oxygen in patients with     fibrotic ILD whose oxygen saturation falls ≤ 88% on a 6MWT, leads to a significant     improvement in health status. The core of the project will be a four week randomised,     crossover controlled trial of ambulatory oxygen used during daily activities. The optimal     Oxygen flow rate is determined by titration at screening visit and administered during     activity for a two-week period, compared to two weeks off oxygen.   "
76382|NCT02286050|"     The purpose of this study is to evaluate the effect of a nursing program in patients with     cystic fibrosis.   "
76391|NCT02285933|"     The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting     balance exercises using virtual reality training will provide additional gains in balance     ability and function over standard inpatient rehabilitation in stroke patients.   "
76392|NCT02285920|"     The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center     study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal     disease.   "
76393|NCT02285907|"     To determine whether the consumption of a beef-rich lunch improves appetite control, satiety,     and energy intake regulation while reducing food reward and food cravings compared to the     consumption of a soy-rich lunch when matched for macronutrients and fiber content or when     match for serving size. The mechanisms of action surrounding the differential responses of     beef versus soy proteins were also explored.   "
76383|NCT02286037|"     Assessments of mechanical skin sensitivity include psychophysical responses to stimulation     with calibrated polyamide monofilaments.      One of the applications of polyamide monofilaments are the assessments of magnitude of     secondary hyperalgesia areas (SHAs), i.e. areas in normal skin near an injury with increased     mechanical sensitivity.      The objective of the study is to investigate the hypothesis, based on previous studies, that     a light tactile stimulus delineates a larger SHA than stimulation with a more rigid     monofilament.      Twenty-three healthy participants were included in this randomized, two-observer, test-retest     study.      A highly significant positive correlation between the bending force of the polyamide     filaments and the magnitude of SHA was demonstrated. The weighted-pin instrument showed     significantly and consistently larger areas than the polyamide monofilaments.      The hypothesis was rejected: a light tactile stimulus did not delineate a larger secondary     hyperalgesia area than stimulation with a more rigid monofilament. The weighted-pin     instrument seems an alternative to the conventional polyamide monofilaments.   "
76384|NCT02286024|"     Depression is a debilitating illness with a risk of developing a treatment resistant form.     Currently, diagnosis is purely clinical with little features available to identify     potentially adverse developments. Clinical features such as early onset age, prolonged     episodes, anxiety, somatic symptoms and apathy are all arguments raising fears the onset of     resistance to conventional treatments. According to neuroimaging knowledge about the     pathophysiological mechanisms, involving front-limbic functional networks supporting the     functions of emotional regulation and reward system, recent work has focused on the     identification of neuroimaging biomarkers predicting therapeutic response. Among the regions     of interest identified, the anterior cingulate cortex, amygdala, hippocampus, and regions     participating in the Default Mode Network Training (Medial prefrontal cortex, posterior     cingulate cortex, inferior parietal lobe) are most frequently areas associated with the     prediction of therapeutic response. Limitations most reported in these studies are the     heterogeneity of experimental paradigms (resting state, cognitive or emotional functional     tasks), imaging (PET scan, MRI) the heterogeneity of clinical resistance criteria forms     studied, different techniques (as that we consider remission (threshold score) or response     (50% decrease from baseline score), and the sample size. Knowing that MRI into daily clinical     practice in the SHU of Adult Psychiatry, as the balance sheet of the disease, monitoring its     evolution, as in assumption rTMS (repetitive Transcranial Magnetic Stimulation) (pretreatment     assessment and neuro), the identification of neuroimaging biomarkers in a population of     patients with clinical criteria of Mood Depressive Episode, with an acquisition of identical     and reproducible image daily routine methodology appears to be a reliable way to correct the     heterogeneity of conventionally published studies on the topic. This study aim to identify,     in routine care, predictive clinical and neuroimaging markers of poor outcome in major     depressive disorder.   "
76385|NCT02286011|"     The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous     Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective,     single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical trial.   "
76386|NCT02285998|"     The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully     licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in     protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age     population.   "
76387|NCT02285985|"     In this research study, Investigators will be comparing the effects of a medication     Saxagliptin versus placebo (a similar looking pill that contains no medication) on     inflammation in the body.      Research Hypothesis DPP-4 inhibition by saxagliptin (ONGLYZA™) reduces adipose tissue     inflammation in obese individuals and this is characterized by decreases in a) reactive     oxygen species (ROS) production, b) toll-like receptors (TLR) and NF-kappa B pathway     activation, c) expression of pro-inflammatory genes, d) macrophage infiltration, and e)     secretion of pro-inflammatory factors.   "
76388|NCT02285972|"     Propofol remains the most common drug for induction of general anaesthesia, although it     causes considerable pain or discomfort on injection. Anesthesia providers have attempted a     large number of remedies to prevent this pain on injection. Previously explored ideas include     injecting propofol into larger veins, warming of the hand with hot packs, and intravenous     pretreatment with numerous other medications. No studies to date have looked at the     dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The     investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of     propofol related pain on injection.   "
76409|NCT02285699|"     This study will examine the gut microbiota and serum inflammatory markers in patients with     Obsessive-Compulsive Disorder vs. healthy controls. Phase II of the study will examine the     gut microbiota and cytokine levels following 12-weeks of treatment with Selective Serotonin     Reuptake Inhibitors (SSRIs).   "
76444|NCT02285244|"     This phase II trial studies how well sotrastaurin acetate works in treating patients with     chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or     Richter's transformation that has returned or that does not respond to treatment.     Sotrastaurin acetate may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
76389|NCT02285959|"     The high-grade malignant brain tumor glioblastoma multiforme (GBM) comprise the majority of     all primary brain tumors in adults. This group of tumors also exhibits the most aggressive     behavior, resulting in median overall survival durations of only 9-12 months for GBM. Initial     therapy consists of surgical resection, external beam radiation or both. Currently, all     patients experience a recurrence after this first-line therapy, so improvements in both     first-line and salvage therapy are critical to enhancing quality-of-life and prolonging     survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can     effectively increase the concentration of drug delivered to the brain while sparing the body     of systemic side effects. This technique threads a tiny catheter through the patient's     femoral artery in the leg, up through the body and neck and into the brain. Once the catheter     reaches the brain, chemotherapy is released to the blood vessels that feed the tumor.   "
76390|NCT02285946|"     During mechanical ventilation, the alveolar recruitment maneuver (ARM) is to apply a positive     end-expiratory pressure (PEEP) (generally 30 cm H2O) for a period of at least 30 seconds. The     realization of MRA is one of three main elements of mechanical ventilation called     protective. This ventilatory strategy, originally described for the ventilation of acute     respiratory distress syndrome (ARDS), and pulmonary and during abdominal surgery is based on     a decrease tidal volumes, optimization of PEEP and the realization of MRA. Protective     ventilation limit the occurrence of atelectasis, the surdistentions and, ultimately,     significantly decreases postoperative complications.      The MRA is currently recommended in the major surgery. Most spine surgery (eg     transpedicular fixation) used in this definition, the MRA are indicated and now commonly     used. This type of surgery requires further positioning the patient in the prone position     (DV). The DV modifies the compliance of the chest respiratory characteristics and changes     (increase in insufflation pressure) and hemodynamic (decreased venous return) of the patient.      Respiratory and haemodynamic effects of MRA made VIS at major spine surgery are not known.     The aim of this observational study, non-interventional, is to compare the hemodynamic and     respiratory effects of MRA performed in DV to those of MRA performed in the prone position     (DD).      The investigators hypothesis is that the respiratory and hemodynamic consequences of MRA     performed in DV is different from those conducted in DD. A better understanding of     hemodynamic and respiratory characteristics of MRA performed in DV would provide a more     tailored to this type of surgery respiratory optimization strategy and reduce respiratory     complications of this surgery.   "
76395|NCT02285881|"     Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different healthcare     settings achieve all treatment goals to prevent cardiometabolic disease. A more personalised     approach with shared decision making should increase that percentage. Because the     ADDITION-Europe study demonstrated two (almost) equally effective treatments but with     slightly different intensities, it may be a good starting point to discuss with the patients     their diabetes treatment, taking into account both the intensity of treatment, clinical     factors and patients' preferences. The aim of the study was to evaluate whether such an     approach increases the proportion of treatment goals that T2DM patients achieve.      Methods: In a cluster-randomised trial in 40 primary care practices that participated until     2009 in the ADDITION Study, 150 T2DM patients 60 - 80 years, known with T2DM for 8-15 years,     will be included. Practices are randomised a second time, i.e. intervention practices in the     ADDITION study could be control practices in the current study and vice versa. For the GPs     from the intervention group a 2-hour training in shared decision making (SDM) was developed     as well as a decision support tool to use during the consultation. These GPs plan the first     visit with the patients to decide on the intensity of the treatment, personalised targets and     the priorities of treatment. The control group will continue with the treatment they were     allocated to in the ADDITION study (treatment-as-before). Follow-up: 24 months. The primary     outcome is the proportion of patients who achieve all three treatment goals (HbA1c, blood     pressure, total cholesterol) at 24 months. Secondary outcomes are the proportion of patients     who achieve five treatment goals (HbA1c, blood pressure, total cholesterol , body weight, not     smoking), evaluation of the SDM process (SDM-Q9), satisfaction with the treatment (DTSQ),     wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping     (DCMQ). The proportions of achieved treatment goals will be compared between groups by     estimating the relative risk of meeting the treatment targets. For the secondary outcomes     mixed models will be used.      Discussion: To achieve optimal diabetes care with a higher proportion of achieved     individualised treatment goals, the SDM approach including a multi-faceted decision support     tool might be useful. An intervention with such a support decision tool is designed.   "
76396|NCT02285868|"     The investigators goal is to provide a mechanism that allows for a better understanding of     patient outcomes following rehabilitation. This includes functional outcomes measured by     standardized and validated tools from the published literature. It incorporates comorbidities     and patient demographic characteristics. It includes measures of general health as well along     with activities of daily living and behavioral health aspects. Measures of quality and     satisfaction and use of Net Promoter Scores also are included. All of these components come     together to form a remarkably comprehensive picture of patients and their associated     outcomes. This is a unique milestone in rehabilitative care and will act to inform and direct     evidence-based approaches and treatment guidelines.      Data are collected via the investigators proprietary electronic medical record system and are     synthetic to the clinical process—that is, the data are collected in real-time with patients     and the scores are immediately provided to the treating therapist as well as archived for     later Registry and scientific use. Subsequent reporting can be risk adjusted to any variable     collected which yields robust insights as to idiopathic patient conditions. However, no PHI     information will be available.   "
76397|NCT02285855|"     The goal of this clinical research study is to learn if giving metformin in combination with     radiation therapy is more effective than radiation therapy alone. In this study, participants     will receive either metformin or a placebo. A placebo is not a drug. It looks like the study     drug but is not designed to treat any disease or illness. It is designed to be compared with     a study drug to learn if the study drug has any real effect.   "
76398|NCT02285842|"     MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy     of its THA and resurfacing components marketed in the EU. These types of studies are required     by regulatory authorities for all THA and resurfacing devices that do not have medium to     long-term clinical evidence available at the time of gaining approval to market in the EU.     This study has been designed in accordance with MEDDEV 2.12/2 rev 2.   "
76416|NCT02285608|"     Investigators are doing this study to examine if a new personalized education program for     patients with mood disorders (depression and bipolar disorders) will help them take their     medications as prescribed by doctors. Investigators will teach patients about how, when and     why it is important for them to take their medications as prescribed. Also, investigators     will ask patients why they do not take medications as prescribed. Furthermore, investigators     will examine whether our education program might save money if it prevents problems related     to not taking medication.   "
76417|NCT02285595|"     A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo     GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.   "
76399|NCT02285829|"     During lumbar spine fusion surgery intraoperative neurophysiological monitoring is in routine     use for prevention of possible nerve injuries during placement of screw into pedicle. Pedicle     screw stimulation test is performed to assess if screw placement is encroaching on the nerve     roots. Relative distance between the pedicle screw and the neighbouring root can be estimated     by the intensity of the current required to activate the root and appropriate muscle. A     properly placed screw can be distinguished from those perforating the pedicle wall by its     higher minimum level of electrical current needed to elicit a muscle response. The minimum     level is deemed as threshold. This test is based on compound muscle action potential (CMAP)     and use of neuromuscular blocking agents (NMBA) should be avoided because of possible cause     of false negative results of screw stimulation test. Neuromuscular blocking agents, which are     in routine use during anesthesia, will have effect on muscle action potential. When NMBA are     used current stimulus will depolarize the same number of axons and the associated muscle     response will be present but of lower amplitude because some percentage of motor fibers will     be blocked by activity of NMBA. At this point, stronger stimulus is needed to recruit     additional axons/muscle fibers , and hence, the measured threshold is elevated.      Train of four (TOF) test is method used to determine level of neuromuscular blockade, by     stimulation of peripheral nerve and following induced muscle contractions. Interpretation of     muscle contractions may be by subjective (visual) or objective (quantitative) method.     Quantitative TOF test may be used prior screw stimulation test by calculating T4/T1 ratio and     obtaining quantitative value which shows level of neuromuscular blockade. Residual     neuromuscular blockade may be present before screw stimulation test, and effect on accuracy     of this test in this situation was not clearly investigated in recent studies.      The purpose of this study would be to determine changes of screw stimulation thresholds under     different range of neuromuscular blockade.Therefore, acceptable neuromuscular blockade     threshold (determined by TOF test) acceptable for obtaining reliable screw stimulation test     should be determined. Screw stimulation test may be performed when neuromuscular blockade is     absent and compared to repeated screw stimulation test when neuromuscular blockade is     present. Different levels of neuromuscular blockade may provide different results on screw     stimulation test, so if difference is statistically significant, induced neuromuscular     blockade level may be set as threshold value, acceptable for obtaining reliable testing     results.   "
76400|NCT02285816|"     This research is being done because these viruses have been shown to shrink tumours in     animals and human tumour samples by selectively killing cancer cells and creating an immune     response to the tumour antigen contained in the viruses. This effect has been shown to     increase when the AdMA3 virus is given first. It is not clear if this treatment will offer     better results than standard treatment.   "
76401|NCT02285803|"     The aim of this study is to evaluate the added effect of tDCS to TRT within patients with     chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real     tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of     therapy, at the end of the counselling and at last a follow-up visit will be planned after 84     days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional     Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary     outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire     and psychoacoustic measurements.   "
76402|NCT02285790|"     The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept,     using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical     management of new primary basal cell carcinoma   "
76403|NCT02285777|"     This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the     effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6     month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as     measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be     invited at the time of their last study visit to participate in this extension study.   "
76404|NCT02285764|"     The purpose of this study is to investigate the potential effects of a modified carbohydrate     nutritional product for obese pregnant women to reduce maternal glycemia.   "
76405|NCT02285751|"     High on treatment platelet reactivity is defined as a poor pharmacodynamic response to the     administration of acetylsalicylic acid or clopidogrel. acetylsalicylic acid and clopidogrel     are drugs commonly used to reduce platelet activity and prevent cardiovascular events. High     on treatment platelet reactivity is associated with a higher cardiovascular event rate.      Ticagrelor and prasugrel, like clopidogrel both P2Y12 inhibitors are effective in treating     patients with High on treatment platelet reactivity to clopidogrel.      Critically ill patients are a unique population with altered pharmacokinetic and     pharmacodynamic properties. Gastrointestinal dysmotility with associated altered resorption     and impaired microvascular function occur frequently in critically ill patients and may lead     to altered resorption of orally administered drugs.      The investigators will test a minimum of 100 patients treated with 100mg acetylsalicylic acid     per os and 100 patients treated with 75mg clopidogrel per os to calculate the prevalence of     high on treatment platelet reactivity.      30 patients with high on treatment platelet reactivity to acetylsalicylic acid will be     randomized to three new treatment groups. In the first group patients will receive 200mg     acetylsalicylic acid per os, in the second group 100mg acetylsalicylic acid intravenously and     in the third group 81mg chewable acetylsalicylic acid. Each group will contain 10 patients.     Pharmacokinetics and pharmacodynamics will be reassessed to evaluate the new treatment.      36 patients with high on treatment platelet reactivity to clopidogrel will be randomized to     receive either an additional loading dose of 600mg clopidogrel (n=24) or to continue normal     treatment as a control group (n=12). Pharmacokinetics and pharmacodynamics will be reassessed     and those patients, who are tested again to have high on treatment platelet reactivity in     spite of the additional loading dose, will now be randomized to receive either ticagrelor or     prasugrel. The investigators expect about six patients per group. The twelve patients in the     control group will continue normal treatment (75mg/day) until the end of the study.     Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel will be assessed. Any     patient, who is tested again with high on treatment platelet reactivity in spite of     receiving prasugrel or ticagrelor, will be finally switched to the opposite drug and a final     high on treatment platelet reactivity testing will be conducted.      16 patients who are treated with 10mg prasugrel per os will be tested for HTPR and if     positively tested will be switched to 2x90mg ticagrelor per os per day. Platelet reactivity     will be reassessed to test whether switching the medication benefits the patients.   "
76406|NCT02285738|"     This research study examines the safety and feasibility of aspirin with or without     Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots     - in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic     (clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as     a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role     in hemostasis, because it is predictive of thrombosis in cancer patients and because of     promising preliminary data. We expect that sP-selectin levels will be elevated in patients     before therapy with aspirin and/or statin, but that these levels will fall significantly     during treatment, rise during the observation phase, and fall during the second study period.     Patients who take part in the study have been diagnosed with a solid tumor cancer and are     considered to be intermediate to high risk for VTE. The standard of care is to give     chemotherapy for solid tumors and treat clots which develop using blood thinners.   "
76407|NCT02285725|"     This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the     knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative     intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma     (PRP) and hyaluronic acid (HA).   "
76408|NCT02285712|"     Peripheral intravenous access is a major intervention in patients admitted to an intensive     care unit. Systematically performed by nurses, it is also an essential intervention when the     central venous access has to be removed. However, in the intensive care unit, patient     centered-characteristics such as previous history of intravenous drug abuse, obesity, history     of multiple vascular punctures or fluid overload most often affect the success rate of this     procedure. For these patients, failure consequences are numerous: 1) delayed discharge from     the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of     catheter-related bloodstream infections. The use of ultrasound has gained increasing     popularity particularly for obtaining central venous access. We hypothesize that, among     trained nurses, ultrasound-guided peripheral venous access could represent an attractive     alternative compared to the traditional anatomical method in order to increase the success     rate.   "
76410|NCT02285686|"     Troponins are sensitive and specific markers of cardiac injury. Critically ill patients     frequently have elevated troponins. In this population, distinguishing patients with elevated     troponins from those with myocardial infarction is difficult. However, troponin elevations on     their own seem to be associated with an increased risk of death. The optimal treatment of     patients with type 2 myocardial infarction or non ischemia related troponin elevations during     critical illness is unclear. There are no trials in the ICU setting to guide management.      This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care     units. The objective of this pilot study is to evaluate the ability to perform a larger     study, which will determine the prevalence, incidence and risk factors for elevated troponin     values, how patients with elevated troponin values are treated as a baseline, and the     incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact     of these conditions and understanding current management will thereafter guide researchers     and clinicians on the importance of carefully evaluating potential risk-modifying therapies.   "
76411|NCT02285673|"     Duchenne muscular dystrophy (DMD) is a genetic disorder caused by an absence of dystrophin     and characterized by progressive muscle degeneration. There is no cure for DMD at present     but, there are several strategies under-researched for treatment of DMD such as steroid     treatment, gene theraphy, exon skipping, stop codon read through and gene repair, cell     theraphy and theraphy with drug that help to produce utrophin protein.      The aim of this study is investigate the eficacy of human umblical cord mesenchymal stem     cells on DMD and understanding if wild type gene can be transfered to the patient.   "
76426|NCT02285478|"     Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination     antiretroviral therapy for treatment of HIV-infected adults according to international     guidelines. For children 3-12 years old, FDA has approved once daily dosing of     darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved     based on a modelling and simulation procedure by the company.      This pharmacokinetic study is designed to validate the proposed dosing recommendation for     once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.   "
76427|NCT02285465|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     ascending multiple oral doses of ASP3700 in healthy subjects.   "
76428|NCT02285452|"     In integrative medicine wraps are applied for different indications. In this study the     effects of thorax with ginger and mustard flour are investigated under standardized     conditions. Heart rate variability, well being, warmth distribution and respiratory activity     of healthy subjects will be measured.   "
77281|NCT02274298|"     This pragmatic cluster randomized controlled trial will test the impact of feedback and a     toolkit aimed at improving the management of chronic kidney disease (CKD) in the primary care     setting. This trial will use family physicians in Ontario participating in the Electronic.   "
76412|NCT02285660|"     The aim of high dose radiotherapy treatment is to deliver enough radiation to the tumour to     kill all the cancer cells while at the same time giving a low dose of radiation to the normal     parts of the body to reduce the side effects of treatment. This requires the cancer     specialist to accurately identify the areas of cancer on a computed tomography (CT) scan.     Positron emission tomography computed tomography (PETCT) scans use radioactive sugar that is     injected into the patient. This sugar goes into cancer cells and shows up as a bright spot on     the PET scan, allowing the doctors to see tumours more accurately. Some cancers move with     breathing, for example lung, pancreas and oesophageal (or gullet) cancers. Fourdimensional CT     scanning (4DCT) is a special type of CT scan that allows the motion of the tumour to be seen     and measured accurately. This information can then be used to help ensure that the     radiotherapy correctly treats the moving tumour.      The aim of this study is to see if there are possible benefits to combining PET with 4DCT to     get a 4D PETCT scan for tumours that move with breathing. This study is divided into three     cancer types; lung, lower oesophagus and pancreatic cancer.      First the investigators are going to test the use of 4D PETCT in the radiotherapy planning of     these tumours to see if it helps the doctor to identify the cancer.      Secondly, the investigators are going to see if the 4D PETCT helps to show areas within the     cancer that are potentially more active. This might then allow us to target a higher dose to     these areas, which could potentially improve the chance of controlling and curing the cancer.     Patients' standard treatment will not be altered by participating in the study.   "
76413|NCT02285647|"     This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence     study of orally- and IV-administered rolapitant in healthy male and female subjects.   "
76414|NCT02285634|"     Nosebleeds (epistaxis) are a frequent cause of emergency department visits, reportedly     inciting 1 in 200 visits. They are most common in those less than ten and older than seventy,     often occurring in the winter months secondary to dry indoor heating. Epistaxis is associated     with elevated blood pressures, but it is controversial whether hypertension is actual a     contributing cause.      In non-life-threatening epistaxis, the first step in management is commonly the application     of a topical vasoconstrictive medication. In many cases this will lead to cessation of the     bleeding or facilitate the exam in those that continue to bleed. Frequently used medications     include phenylephrine, oxymetazoline, and lidocaine with epinephrine.      Classic teaching has been to avoid the use of these medications in patients with elevated     blood pressures due to concerns of inducing hypertensive crisis. Strict avoidance of topical     vasoconstrictors in this patient group with epistaxis severely limits the treatment options     for a many patients given the association between the two conditions.      Though universally taught, the actual effect of these agents on blood pressure remains     unquantified. Studies investigating the prevention of nose bleeding during nasotracheal     intubations suggest that the effect might be minor with little variation between agents.      Clinical question:      What is the effect of commonly used intranasal vasoconstrictors on blood pressure in     volunteers without a history of hypertension.   "
76415|NCT02285621|"     Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10%     will need a brace treatment during pubertal growth spurt. The design is made relatively     corsets empirically, hence the relative efficiency of this treatment. Our team has developed     innovative methods for design, optimization and computer aided manufacturing-based numerical     simulation models customized to each patient, and a system of evaluation and adjustment of     corsets. In this project, the investigators will evaluate the effectiveness of this platform     customized treatment and demonstrate its clinical application   "
76418|NCT02285582|"     The rare histiocytic disorders (RHDs) are characterized by the infiltration of one or more     organs by non-LCH histiocytes. They can range from localized disease that resolves     spontaneously, to progressive disseminated forms that can be sometimes life-threatening.     Since they are extremely rare, there is limited understanding of their causes and best     treatment options. Physicians, patients and parents of children with RHDs frequently consult     members of the Histiocyte Society regarding the best management of these disorders. Very     often, no specific recommendation can be made due to the lack of prospective outcome data, or     even large retrospective case series. The creation of an international rare histiocytic     disorders registry (IRHDR) could facilitate a uniform diagnosis of the RHDs, as well as the     collection and analysis of the clinical, epidemiological, treatment and survival data of     patients with RHD. The registry may also lead to future therapeutic recommendations, provide     a framework for future clinical trials and create excellent research opportunities.   "
76419|NCT02285569|"     During a caesarean section the blood pressure is usually measured every few minutes and it     may fall too quickly to be detected in a timely fashion by this intermittent means. The     monitor the Masimo Rainbow SET® (MRS) uses a peg attached to a finger to detect (amongst     other things) the flow of blood through it. One of the measures it takes is called the Pleth     Variability Index (PVI) which (unlike standard blood pressure measurement) it measures     continuously. The investigators would like to try the MRS on patients to see if the PVI can     be used to predict falls in blood pressure.   "
76420|NCT02285556|"     The purpose of this research is to inspire new medical ideas using brain image technology for     the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition     damage.   "
76421|NCT02285543|"     To confirm the subgroup result from TPF (docetaxel, cisplatin and 5-fluorouracil ) trial     (NCT01542931) that cN2 OSCC patients could benefit from TPF induction chemotherapy compared     to the standard treatment.   "
76422|NCT02285530|"     The purpose of this study is to confirm the predictive value of GDF15 expression for TPF     induction in T3/T4cN0M0 patients with OSCC   "
76429|NCT02285439|"     The main purpose of phase I studies in general is to determine the best dose (maximum     tolerated dose) of a drug, and to find out the most common side effects. The main purpose of     the phase I component of this study specifically is to determine the best dose of the     experimental drug MEK162 and to find out whether the drug is safe in children and adolescents     with tumors that have grown or come back despite standard therapy.      Another purpose of this study is to measure the concentration of drug in the blood to help     understand how much drug gets into the body and how quickly the drug is removed from the     body. Another purpose of this study is to determine whether MEK162 turns off the Ras/Raf/MAP     pathway as expected by measuring this pathway in blood cells. Finally, in this study, the     investigators hope to start finding out whether or not MEK162 causes different types of     tumors in children to shrink or stop growing.      The main purpose of the phase II component of the study is to determine whether MEK162 causes     specific types of tumors in children and adolescents to shrink or stop growing. These     specific types of tumors include low-grade gliomas, tumors in patients with a genetic     condition called neurofibromatosis type 1, and other tumors thought to be caused by abnormal     activation of the Ras/Raf/MEK molecular pathway.      Another purpose of this study is for researchers to learn whether specific abnormalities in     the DNA of tumors can help predict whether tumors will respond to MEK162.   "
76430|NCT02285426|"     Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways     and pivotal for the diagnosis and staging of lung cancer. Further technological improvements     have resulted in high definition (HD+) images and advanced image enhancement technique     (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination     with i-scan technology is superior to HD+WL (white light) for detecting endobronchial     vascular changes. In this study we aim to correlate these vascular changes to histology and     hypothesize that these vascular changes are related to (pre-) malignant changes and that the     addition of i-scan is superior to HD+ WL.   "
76431|NCT02285413|"     This is an exploratory study and the primary objective is the immunogenicity and feasibility     of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and     clinical efficacy. This study will provide important data on the immunological efficacy of DC     immunochemotherapy.   "
76432|NCT02285400|"     Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by     airflow limitation that is progressive and not fully reversible. Expiratory flow limitation     (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and intrinsic     positive end-expiratory pressure (PEEPi). DPH and PEEPi lead to increased inspiratory muscle     efforts and impaired central drive mechanical and ventilation coupling, which is an important     mechanism of dyspnea. Appropriate setting of extrinsic PEEP (PEEPe) can decrease inspiratory     efforts and work of breathing, improve patient-ventilator synchrony in severe COPD patients     with PEEPi and treated with mechanical ventilation. Nevertheless, the effects of CPAP/PEEPe     level on respiratory mechanics, especially on central drive mechanical and ventilation     coupling, still need further investigations.      In the present study, about 40 patients with COPD will be recruited as research subjects. And     the investigators aim to observe the changes in respiratory mechanics, central drive     mechanics, central drive mechanical and ventilation coupling at different levels of CPAP.     Contrast analysis will be conducted to evaluate the effects of CPAP level on respiratory     mechanics and central drive during DPH, which may provide a reasonable basis for the clinical     application of CPAP to COPD patients and the exploration of a new reasonable CPAP setting     method.   "
76433|NCT02285387|"     Prospective randomized (rhythm control or rate control) Objective of study        1. To analyze long term outcome of patients with acute stroke with atrial fibrillation          according to the rhythm control        2. To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with          acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion,          catheter ablation)   "
76443|NCT02285257|"     The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan     subdistrict in Beijing in mainland China).   "
76453|NCT02285127|"     Is there a functional outcome difference when treating pertrochanteric fractures with a short     or long cephalomedullary nail?   "
76434|NCT02285374|"     This is a phase IV, open label, multicentre trial that will be taking place at 4 sites in the     United Kingdom (UK). Efavirenz which is taken in combination with Kivexa® or as part of the     combination pill, Atripla® is a recommended firstline regimen for the treatment of Human     Immunodeficiency Virus-1 (HIV- 1) infection. Treatment against the HIV virus is also referred     to as antiretroviral therapy.      Toxicity is the most common reason for modification of firstline therapy. Central Nervous     System (CNS) side effects such as difficulty with sleeping & bad dreams are common side     effect of Efavirenz based therapy and is one of the most frequent reasons for switching or     discontinuing highly active antiretroviral therapy.      Dolutegravir is within a novel class of antiretroviral agents licensed in the UK for the     treatment of HIV. In combination with Truvada®, it showed fewer side effects when compared to     Efavirenz in other clinical studies, where patients were starting HIV treatment for the first     time, or switching from other agents.      The purpose of the study is to investigate the benefits of switching away from Eefavirenz (in     combination with Kivexa® or as part of the combination pill, Atripla®) to Dolutegravir in     patients with CNS side effects (such as difficulty with sleeping, bad dreams etc).   "
76435|NCT02285361|"     To monitor the safety profile and efficacy of GIOTRIF®(afatinib dimaleate, q.d) in Korean     patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)   "
76436|NCT02285348|"     Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by     progressive cerebellar ataxia, immunodeficiency, chromosomal instability, and cancer     susceptibility. The underlying mechanism and process of neurodegeneration leading to loss of     cerebellar neurons and neurological function is largely unknown. Laboratory diagnostic     approaches to neurodegeneration in A-T are hampered by sampling issues. It is dangerous,     impractical, and not ethically to directly sample brain tissue by surgical biopsy. In     contrast cerebrospinal fluid (CSF), a fluid that is in direct contact with brain tissue, is     relatively easy to sample in a safe procedure (lumbar puncture). The aim of the proposal is     to investigate oxidative stress, low grade inflammation and tissue break down in the brain of     A-T patients by analyzing CSF. In addition the alterations in protein expression related to     A-T will be quantified by liquid chromatography/mass spectrometry (LC/MS)-based proteomic     analysis of CSF from healthy individuals and A-T patients to determine candidate proteins     (new biomarkers) which relative expression levels could be used as surrogate marker of     disease progression.   "
76437|NCT02285335|"     The purpose of the study is to evaluate the effect of GINST on human semen. The study is a     pilot study, designed as open-label, prospective randomized clinical trial using GINST either     500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two     capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a     dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax ginseng).     Expected participants are to be male partners of female patients who visit infertility clinic     at Severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis     using computer aided sperm analyzer (CASA). Semen analysis, blood test, questionaires are     planned to be performed 2 times, on the initial visit and after 12weeks of GINST treatment.     Semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total     leukocyte count, total motile sperm count, further analysis including sperm chromatin     assessment to examine the quality of sperm and malondialdehyde (MDA) analysis of seminal     fluid to assess oxidative stress will be performed. Blood test will be done including serum     follicle stimulating hormone (FSH), luteinizing hormone (LH), total and free testosterone.     Quality of life, sexual performance before and after taking GINST will be evaluated using     questionaires.   "
76438|NCT02285322|"     Current guidelines for the clinical management of hypertension in adults recommend to achieve     and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what proportion     of individuals identified with high blood pressure in primary care actually reach blood     pressure control, what factors are associated with attainment of control and to what extent     blood pressure control attainment is associated with cardiovascular diseases in a     contemporary population of individuals diagnosed with high blood pressure.      The aim of this study is to investigate the extent to which patients achieve blood pressure     control and associated risk factors, time to attainment of blood pressure control and whether     this time is associated with an increased risk of CVD onset, all-cause and cardiovascular     disease and end-stage renal disease.   "
76439|NCT02285309|"     This observational clinical trial will investigate the following perioperative indices     relating to cardiac surgery:        1. The significance of measurements involving left heart relaxation (LV diastolic function)          and its relation to outcome measures.        2. The significance of measurements involving right heart relaxation function and itrs          relation to outcome measures.        3. The influence of drugs such as enoximone on these outcome measures.   "
76440|NCT02285296|"     Elderly cancer patients need more help from their relatives and for longer than young adults.      Our hypothesis of research is that the needs and resources to help the couple  elderly     patient/caregiver , are at least in part socially determined and that the implementation of     a personalized support plan to help the caregiver (PSP) taking into account needs, resources     and expectations of the primary caregiver in addition to those of elderly patients with     cancer may partly correct inequalities. The PSP should allow a better management of cancer, a     lesser burden for the caregiver and a better quality of life for both the caregiver and the     patient.   "
76441|NCT02285283|"     The purpose of this randomized controlled double-blinded trial is to determine if the     addition of an oral antifungal to typical post-operative medical therapy can prevent or     reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic     rhinosinusitis with nasal polyps (CRSwNP).   "
76442|NCT02285270|"     Brown adipose tissue is poorly understood fat that can metabolize glucose in order to     generate heat. Since activated brown fat has a high metabolic rate, it is of great interest     as a potential target to combat obesity. However, the signaling and control of brown fat     metabolism is poorly understood. Because brown fat uses glucose as its energy source, brown     fat metabolism can be imaged with PET/CT using the positron emitting glucose analog F-18 FDG.     We have recently shown in mice a striking circadian variation in brown fat metabolism as     evidenced by changes in FDG uptake. In this study we endeavor to generate pilot data on a     potential circadian variation in brown fat activation in healthy humans.   "
76445|NCT02285231|"     In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes     were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group.     We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free     fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and     after the 6-week intervention.   "
76446|NCT02285218|"     To investigate the predictive roles of adipokines and hepatokines to detect non-alcoholic     fatty liver disease (NAFLD), diabetes, or dyslipidmia.      To examine the association or effects of clinical and biochemical factors (lab results and     medication, etc.) on serum levels of adipokines and hepatokines in certain subjects with     non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.   "
76457|NCT02285075|"     The current study aimed to explore the pharmacokinetics of temocillin in patients treated     with haemodialysis and to demonstrated whether or not the pharmacodynamics target of a time     above a MIC of 16 mg/L of more than 40 and 60 % of the dosing interval could be obtained with     a dosing schedule of 1 gram/24 hours, 2 gram/48 hours and 3 gram/72 hours, all of these doses     given after haemodialysis sessions only.   "
76690|NCT02282124|"     The aim of this study is to investigate the effectiveness of the program in patients after     renal transplantation using a randomized controlled trial design. Physical, behavioural, and     clinical outcomes will be measured at baseline before randomization then 8 and 12 months     later.   "
76447|NCT02285205|"     Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist     that decreases insulin resistance in the periphery and liver resulting in increased     insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It     demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison     to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the     only drug which is considered as an effective therapeutic agent for improving non-alcoholic     fatty liver disease (NALFD) in type 2 diabetes (T2D).      The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4 study     is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on     intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD.      Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet     once daily) for 24 weeks.      Primary endpoint is changes from baseline in controlled attenuation parameters (CAP) measured     by transient elastography (fibroscan) after treatment with Lobeglitazone.      Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated albumin),     Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function parameters     (AST, ALT, r-GT), and adverse events during the trial.   "
76448|NCT02285192|"     The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose     (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us     more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain     cancer.   "
76449|NCT02285179|"     This study is designed as a phase 1 dose escalation study followed by a randomised phase II     study. The study will be performed in three different centres: Addenbrooke & Cambridge     university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron     Hospital (Barcelona, Spain).      Three to six patients will be followed for one completed cycle of therapy (28 days) and     subsequent enrolment of new cohorts will be based on the safety assessment in that first     cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy     of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with     tamoxifen alone.   "
76450|NCT02285166|"     The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events     associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga     Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical     practice.   "
76451|NCT02285153|"     Platelets play a central part not just in homeostasis and thrombosis as the primary effector     cells, but they are also key cells in the regulation of the immunological response to various     stressors. After activation, platelets release their granules which store different     inflammatory mediators that induce coagulation, recruit further platelets, activate     complement, attract neutrophils and leukocytes and regulate the vascular tone. Platelets     activated by systemic inflammation and infection, may also contribute to the development of     multiple organ failure. Thus, inhibition of platelet activation may have beneficial effects     on critically ill patients.      the investigators hypothesize that acetylsalicylic acid reduces the mortality of medical     intensive care unit patients. In a retrospective study acetylsalicylic acid use was     associated with a substantial reduction in a medical intensive care unit population (Winning     et al., 2010).      The investigators will conduct a randomized, double-blind study including 460 patients     (2x230), who will be randomized to receive 100mg acetylsalicylic acid(daily, intravenous) or     a placebo (0,9% sodium-choride solution) to assess whether acetylsalicylic acid reduces the     mortality of medical intensive care unit patients.      Main outcome criteria will be 28/90day-mortality. Furthermore the investigators will assess     whether acetylsalicylic acid reduces the risk of suffering thromboembolic complications.      Post-mortem examinations will be conducted in all patients who die in the course of the     study.      Furthermore we will assess bleeding rates, intensive care unit mortality and pharmacokinetic     and pharmacodynamic properties of acetylsalicylic acid in the intensive care unit population.   "
76452|NCT02285140|"     There is clinical equipoise about the question of whether antibiotic prophylaxis should be     given for a short period or an extended period of time as reflected by inconsistencies in     major guidelines, current practices at Canadian centers, and as concluded in the three     systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to     routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined     antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as     infections with C. difficile or emergence of resistance, but may also reduce the incidence of     s-SSIs. The objective of the eventual full scale study is to determine whether adding     vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as     effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to     assess the feasibility to conduct this factorial cluster randomized cross-over trial, the     adherence to the study protocol at each pilot site, the length of time to fill out the case     report forms, and to get reliable estimates of event rates for sample size calculation for     the main study   "
76454|NCT02285114|"     This study will evaluate the pharmacokinetics (PK), safety, and efficacy of     emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected children and adolescents     virologically suppressed (defined as having < 50 copies/mL of HIV-1 RNA for a period of at     least 6 months) while on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor     (NRTI) containing regimen.   "
76455|NCT02285101|"     The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as     an infusion to treat patients who bear advanced solid tumors that are dependent on arginine     (melanoma, renal cell carcinoma, prostate cancer and hepatocellular carcinoma), and who have     progressed after receiving approved or established therapies. This is a Phase 1 study;     PEG-BCT-100 is an enzyme that degrades arginine and is an investigational drug.   "
76456|NCT02285088|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and     pharmacodynamic effects of GBT440 compared with placebo in healthy subjects and subjects with     sickle cell disease (SCD).   "
78627|NCT02256696|"     Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to     first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic)     over 12 weeks of treatment. Funding Source - FDA OOPD   "
76459|NCT02285049|"     Chronic urticaria symptoms commonly fluctuate from day by day. Consequently the clinical     presentation of a patient in each visit is not representative of the current disease status.     Dermatologists are trying to integrate an evaluation process of each treatment visit     regarding both clinical condition and life quality concern. The Urticaria Control Test is the     key for a better treatment outcome in a routine management. To translate this questionnaire     into Thai is essential in our subject of interest for offering local patients a higher     well-being standard. The Thai-version test will encourage enhanced as well as impactful     therapeutic options for Thai chronic urticaria patients.   "
76460|NCT02285036|"     A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and     immunogenicity demonstrated in the phase III trial in China. A large scale, double blind,     randomized, PNEUMOVAX 23 (Merck & Co., Inc.) controlled phase 3 clinical trial was conducted.   "
76461|NCT02285023|"     In the majority of patients with the chronic urticaria, the etiology is unclear, leading to     difficulties in treatment and high rates of recurrence. According to the International     EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of     Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network     (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in     Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management     is the key for a better treatment outcome. To translate this questionnaire into Thai is     essential in our subject of interest in order to effectively apply it to local patients. The     Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options     for Thai chronic urticaria patients.   "
76462|NCT02285010|"     This study aims to compare the effect of pre-operative oral pregabalin on post operative     morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.   "
76463|NCT02284997|"     Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver     oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The     meibomian glands may become obstructed due to change in meibum quality. When meibum thickens     and solidifies, it plugs the gland openings and oils can no longer reach the tear film. The     blockage of the glands is the primary cause of meibomian gland dysfunction (MGD), and may     result in symptoms of dry eye (burning, stinging, grittiness, etc.). The typical treatment     for MGD is a procedure called warm compresses. It is a combination of applying heat and     pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the gland     openings, and allow oils to flow normally onto the tear film once again. One way to apply     heat to the eyelids is by using the MGDRx® EyeBag. The EyeBag is microwaved for 30-40 seconds     under full power, and is placed over the closed eyes for approximately 10 minutes. The eyes     are gently massaged afterwards.      The purpose of this study is to determine how effective the EyeBag is at improving MGD and     dry eye symptoms.   "
76464|NCT02284984|"     The present study investigates the potential of a new therapeutic approach in lupus nephritis     combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the study is to     assess the reduction (and seroconversion) of pathogenic autoantibodies, to evaluate clinical     improvement and assess the safety and feasibility of long-term B-cell depletion.   "
76465|NCT02284971|"     This study evaluates the combination of stereotactic body radiation therapy (SBRT) and     CDX-1127 in subjects with castration resistant prostate cancer. Subjects will be randomized     to one of three arms to receive SBRT prior to, after, or in conjunction with the first dose     of CDX-1127.   "
76466|NCT02284958|"     This study will investigate if a 12-week, individually-tailored walking program, using     pedometers will be a more clinically and cost-effective option for the management of chronic     low back pain than standardized advice and education.   "
76467|NCT02284945|"     Spread of cancer to the spinal column is a growing problem in patients with cancer. It can     cause a number of problems including pain, instability and neurologic problems. If left     untreated, progressive weakness, numbness and bladder/bowel disturbance occurs. The aim of     treatment is to help with pain and to reduce the risk of these neurological problems. This     treatment has traditionally been radiotherapy to the spine. Surgery has always meant large     open operations with a long recovery time and significant risk of complications. There has     been new technology that has allowed less invasive operations to take place to stabilise the     spine. The aim is to relieve the pressure on the spinal cord in addition to stabilising the     spinal cord. These techniques are called 'minimally invasive' and include surgical techniques     such as cement augmentation and percutaneous instrumentation.      The aim of this study is to compare traditional open operations with these new minimally     invasive techniques to see if they do result in reduced complications and quicker recovery in     addition to achieving the goals of surgery.   "
76468|NCT02284932|"     Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most     troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to     poor functional status and premature mortality.      One prevailing hypothesis stipulates that the deterioration in muscle structure and function     during COPD results from a spillover of inflammatory mediators from the lungs to the systemic     circulation and then to the muscles.   "
76470|NCT02284906|"     The purpose of this study is to evaluate the effect of pioglitazone at 24 months compared     with placebo on cognitive decline in high-risk participants who have completed the     AD-4833/TOMM40_301 study [NCT01931566] with an adjudicated diagnosis of mild cognitive     impairment (MCI) due to Alzheimer's Disease (AD).   "
76471|NCT02284893|"     A combination of saxagliptin and dapagliflozin added concurrently to metformin in combination     with diet and exercise is superior to sitagliptin added to metformin in combination with diet     and exercise in reducing mean HbA1c over a treatment period of 26 weeks.   "
76472|NCT02284880|"     Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory     blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female     subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API)     sources of eslicarbazepine acetate (ESL)   "
76473|NCT02284867|"     Research question:      Population of study: women diagnosed as term pregnancy in labor (control) and the other group     diagnosed as preterm labor (cases).      Intervention: measuring uterine natural killer cells . Outcome: uterine natural killer cells     has a role in initiation of preterm labor.      Research hypothesis:      • Are uterine Natural Killer cells involved in the initiation of preterm labor ?      Medical Application:      • Possibility of prediction of preterm labor by assessment of Natural killer cells as well as     preventing preterm labor by suppressing their activity .   "
76474|NCT02284854|"     Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the     effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ     pharmacokinetics.   "
76475|NCT02284841|"     This study evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain     following the surgical removal of lower wisdom teeth. All participants will have two lower     wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the     patients' face for 60 minutes post-operatively, thus the patient being their own control.   "
76476|NCT02284828|"     Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral     dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.   "
76477|NCT02284815|"     Type 1 diabetes (T1D) emerge when the auto-immune destruction exceeds the beta cell's     regenerative capacity. The patients' beta-cell capacity increases shortly after onset when     glucotoxicity decreases after the start of insulin therapy. Children have fewer beta cells     and therefore shorter remission; but the expansion potential is larger the younger the child     is. The problem with the majority of intervention studies is the many and serious side     effects, or a quite marginal effect on the residual beta-cell function. However, in animals     that had received gluten-free diet, the T1D incidence fell from 61% to only 6%. Gluten-free     diet increases the number of regulatory T cells in Peyer's patches, affect the composition of     intestinal microflora and modify the balance between pro and anti-inflammatory cytokines in T     cells. Therefore, the aim of our study is to prolong the remission phase by introducing a     gluten-free diet intervention to children at T1D onset.   "
76478|NCT02284802|"     Confocal endomicroscopy is an emerging technique that allows in vivo imaging of cells and     tissue structures of the gastrointestinal mucosa, with a magnification of about 1000 times,     guiding optical biopsies in real time. Confocal endomicroscopy represents technique that     combines conventional white light image with the confocal microscope probe, thereby allowing     examination of the surface epithelium in vivo and histological diagnosis during endoscopy.     Among the applications already established for its use, stand out diagnosis of Barrett's     esophagus, gastric atrophy and intestinal metaplasia, celiac disease, differentiation of     hyperplastic adenomatous polyps of the colon, microscopic colitis and follow-up of patients     with inflammatory disease, reducing the need for endoscopic biopsies. The CLE can still     detect molecular changes effectively improving the endoscopic diagnosis. This pilot project     consists of 07 subprojects which the technology of confocal endomicroscopia will be evaluated     and compared with the histological results of biopsy or surgical specimens:      1. confocal endomicroscopy for the diagnosis of high-grade dysplasia and superficial     esophageal adenocarcinoma in patients with Barrett's esophagus 2 Diagnosis of superficial     esophageal squamous cell carcinoma in patients with head and neck cancer by confocal     endomicroscopy 3 Detect the presence of premalignant lesions in the gastric stump in patients     with reflux alkaline gastritis after partial gastrectomy 4. detect lesions in the gastric     mucosa of patients with familial history of gastric cancer 5 Biliary Strictures: differential     diagnosis by confocal endomicroscopia 6 confocal Endomicroscopy of cystic neoplasms of the     pancreas 7 Contribution of confocal endomicroscopy for the differential diagnosis of     colorectal polyps The project aims to deploy the structure of the Confocal endomicroscopy     Endoscopy ICESP, for performing in vivo histological examinations of the digestive tract,     biliary tract and pancreas. All research groups involved in the early detection of tumors of     the esophagus, stomach, biliary tract, pancreas, colon and rectum may benefit from the     implementation of this methodology.   "
76479|NCT02284789|"     To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment     Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a     population of adults with moderate to severe hemophilia A treated with coagulation factor     VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.   "
76480|NCT02284776|"     The goal of this study is to assess the effect of a therapeutic education program in addition     of a hydrotherapeutic cure on obese patients.      The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a     dietary follow-up, a physical activities program, working group.   "
76481|NCT02284763|"     The aim of this study was to investigate the relationship between the end-tidal carbon     dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the     pharmacodynamic relationship between EtCO2 and rSO2.   "
76482|NCT02284750|"     The purpose of this study is to establish the optimal strategy for stenting in coronary     bifurcation lesion.   "
76483|NCT02284737|"     Pulmonary arterial hypertension (PAH) is characterized by premature death mainly because of     progressive and severe right ventricular failure. Target drugs are reported to be associated     with significant improvement of clinical outcome for PAH patients. However, previous studies     using those target drugs focused on the change of 6-minute walk distance (6MWD) and or     hemodynamic responses. As 6MWD has weak correlation with clinical outcome (time to clinical     worsening, TTCW), benefits from targets for PAH patients are not clear. We previously     reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH     who were unresponsive to target drugs. However, there is a lack of a randomized study to     identify the effect of PADN on PAH.   "
76484|NCT02284724|"     To examine for differences in contraction thickness of the transversus abdominis muscle in     symptomatic subjects with mechanical lower back pain following the application of dry     needling to the lumbar multifidus muscles.   "
76752|NCT02281201|"     The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex     Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced     by vitamin K antagonists in Japanese subjects who require immediate correction of     international normalized ratio (INR) due to a major bleed or emergency surgery.   "
76485|NCT02284711|"     Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant     proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now     recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The     principal objective of the present study is to assess the impact of salpingectomy on ovarian     reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular     resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve     results between two coagulation techniques used in salpingectomy: bipolar electric energy     versus ultrasound.      The study design is single-center, prospective, before-and-after, with open randomization     between two groups defined by coagulation technique.   "
76526|NCT02284165|"     Retrospective analysis of Get With the Guidelines-Stroke data linked with Medicare claims and     the AVAIL longitudinal data sets to assess patterns, predictors, and outcomes associated with     the use of rehabilitation services following hospitalization for ischemic stroke. Primary     completion defined as the end of primary analyses, consistent with the end of the PCORI Cycle     I grant period. Study completion defined as acceptance of final research report and lay     abstract by PCORI.   "
76486|NCT02284698|"     A community-randomized trial comparing villages randomized to receive an intervention     consisting of a trained community health volunteer who brings patients to the nearest Vision     Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to     control villages receiving no additional intervention. The primary outcome of corneal ulcer     will be measured by baseline and annual population-based census performed in both     intervention and control villages by masked examiners from baseline to 24 months. Each     resident in the village will be asked about their ocular history and, if suspected of having     a corneal ulcer, will be examined for evidence of a corneal opacity. Annual visits will     occur, coinciding with the end of the harvest season. In villages randomized to intervention,     an active promotion campaign will be undertaken to urge residents to notify the village eye     health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers     will be treated if they present to a clinic or are found during the annual monitoring visits,     but active promotion of corneal abrasion care will not be offered.   "
76487|NCT02284685|"     Eating disorders (EDs) have the highest rate of mortality of any mental illness. On U.S.     college campuses, an estimated 80% students with clinically significant ED symptoms do not     receive treatment. There are likely more than one million students whose EDs go untreated in     any given year. Left untreated EDs typically become more severe and refractory to treatment.     Given the impact of EDs on mental and physical health and the connection therein with social,     academic, and economic outcomes, an effective intervention to increase rates of treatment     utilization would have broad societal effects extending well beyond the campus setting. This     study is an online intervention designed to identify and increase help-seeking among     undergraduates with previously undiagnosed/untreated EDs.   "
76488|NCT02284672|"     Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA).     But propofol alone can be not sufficient for inhibiting upper airway reflex and also result     in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2     receptor agonist with analgesic and sedative effects but sparing respiratory function.     Therefore propofol combined with dexmedetomidine induction could be more effective in     preserve respiration under same condition for LMA insertion than propofol alone. In this     study, the investigators investigate the clinical dose of propofol for LMA insertion with     premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.   "
76489|NCT02284659|"     Objective: The aim of this study is to evaluate the FES effect on erectile function in men     with erectile dysfunction.      Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.   "
76490|NCT02284646|"     Purpose: to assess the efficacy of a physical training program in patients with ankylosing     spondylitis (AS) in a randomized controlled study   "
76491|NCT02284633|"     In non-small celled lung cancer (NSCLC) 10-15% of the patients harbor a mutation in the     tumor's epidermal growth factor receptor (EGFR M+). This receptor is the target for treatment     with erlotinib. Identification of EGFR M+ is done on a biopsy, which can be difficult to     retrieve. A new blood based test identifies EGFR M+ in plasma, which makes it possible to     monitor the level of EGFR M+ in the patient's blood during treatment. This enables both a     closer monitoring of the treatment with erlotinib and a closer study of the resistance     mechanisms that almost inevitably develop during treatment. A pilot study demonstrated that     the quantity of EGFR M+ in plasma correlates to the response to treatment and might be used     to predict disease progression.      Patients with disseminated EGFR M+ NSCLC referred to a participating oncology department may     be enrolled in the project. The investigators expect to include 200 patients over a two-year     period. Patients will receive standard lines of treatment and follow up. Standard 1st line     treatment for these patients is erlotinib. A biopsy and blood sample will be retrieved before     treatment with is initiated. The patient will be monitored prospectively with blood samples     every 3rd-6th week both during erlotinib treatment, subsequent lines of treatment and     treatment intermissions. The blood samples are analyzed for subtypes of EGFR M+ both     sensitizing mutations and mutations known to drive resistance to erlotinib treatment. In the     event of occurring resistance mutations or unexpected increase in quantity of sensitizing     mutations clinical action will be taken; initially in the form of additional scans searching     for signs of disease progression. Clinical data will be retrieved from the patient's medical     journal. Patients are followed until death or at least 24 months after inclusion. Any excess     biological material will be stored for up to 15 years in a bio bank for future research     purposes.      We expect our results to validate the use of EGFR M+ detection and quantification via blood     samples in a clinically relevant setting. The investigators expect earlier identification of     disease progression to allow more cases of local treatment thus - hopefully - increasing the     progression free survival. Continued blood monitoring in subsequent lines of treatment and     treatment intermissions will add to our knowledge of the nature of EGFR M+ NSCLC. The     sampling of biological material allows us to further investigate the biology of resistance.   "
76492|NCT02284620|"     Post-operative pain after total knee arthroplasty is usually severe and impair the functional     recovery of operated joints.The purpose of this study is to determine whether post-operative     continuous femoral nerve block analgesia is superior to local wound infiltration combined     with intravenous patient controlled analgesia in improving joint function and reducing the     incidence of chronic post-surgical pain (CPSP).   "
76493|NCT02284607|"     This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety,     tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as     compared to placebo when administered to healthy volunteers.   "
76512|NCT02284360|"     This is a prospective, single center, randomized, double-blinded, placebo-controlled,     exploratory phase I clinical trial in healthy male subjects to investigate the safety and     tolerability of the cytokine based gel APOSEC™. The proof of safety and tolerability of     APOSEC™ is the primary objective. The secondary objective is to measure the extent of wound     healing of APOSEC™.   "
76753|NCT02281188|"     The aim of this registry is to evaluate the incidence, indications and outcomes of patients     presenting with UTUC in relation to the different treatment modalities used.   "
76494|NCT02284594|"     Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations     annually. While vaccination is the cornerstone of preventing influenza infection, vaccination     coverage in adults is low. Latino adults have the lowest coverage rates. Text message     reminders have been used successfully for improving influenza vaccination for children. This     study will assess the use of text messaging to improve influenza vaccination coverage rates     in a largely minority, publicly insured adult population. We will also assess if the patient     having received a text message makes the patient more likely to accept vaccination when their     provider has received in electronic alert regarding need for influenza vaccination in the     electronic health record.   "
76527|NCT02284152|"     In the present study, we tested a novel approach to understanding infant bottle-feeding     interactions: experimentally manipulating bottle-feeding conditions to better understand     maternal and infant influences on overfeeding, as well as individual differences in risk for     overfeeding. Specifically, we observed mother-infant dyads during a typical, mother-led     feeding, during which mothers were given no instruction regarding how or how much to feed     their infants (hereafter referred to as a typical feeding [TF]), as well as during an     infant-led (IL) feeding, wherein we minimized the mothers' influence on the feeding and     ensured the feed was in response to the infants' hunger and fullness cues. Using this     within-subject, objective, and experimental approach, the present study aimed to: 1) directly     measure the extent to which overfeeding occurs during bottle-feeding and 2) describe the     characteristics of infants and mothers that overfeed during bottle-feeding.   "
76495|NCT02284581|"     Breast cancer is the most common cancer in many countries: in Italy about 48.000 new breast     cancers are diagnosed every year and, despite improvements in diagnosis and therapy, about     13.000 women die every year for this disease . About 6-7% of breast cancer patients are     metastatic at diagnosis , while the majority of patients with stage IV has a previous history     of breast cancer that has already been treated. According to various prognostic factors     (tumor size, lymph nodes involvement, grading, hormone receptors status, HER-2 status), in     the worst-case scenario, more than 30% of node-negative breast cancer patients and more than     70% of node-positive patients relapse2.      The evolution of metastatic breast cancer has changed considerably in the last years with the     approval of new drugs. In fact, already in 2003 Giordano et al showed that the prognosis of     metastatic breast cancer patients was improved significantly from 1970's to 2000 with a     median survival of 15 months in the early 1970's compared with 60 months in the last 1990's.      This significant survival gain was obtained with introduction of new drugs as hormonal,     chemotherapeutic and biological agents. The greater availability of drugs has led to an     increase in number of lines of treatment receiving by metastatic breast cancer patients.     However, there are few published data on actual duration of metastatic breast cancer     treatments. Moreover, there is no evidence to support a real impact on survival of treatments     beyond the second-third line.      Recently, a retrospective analysis of about 199 metastatic breast cancer patients treated     with chemotherapy showed that tumor subtype is associated with the duration and number of     lines of chemotherapy (for example HER positive versus triple-negative patients) .   "
76496|NCT02284568|"     This Phase 2 study is intended to serve as a proof of concept for potential treatment with     laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod     in this population.   "
76497|NCT02284555|"     This study will assess the nasal eradication of SA in healthy subjects following treatment     with mupirocin 2% (Bactroban 2% Nasal Ointment) twice daily for 5 days, by means of a broth     enriched culture microbial assay. The sensitivities of broth enrichment and plating assay     methods will be compared. The safety and tolerability of Bactroban 2% Nasal Ointment will     also be assessed.   "
76498|NCT02284542|"     The primary objective is to demonstrate the safety and efficacy of a non-awake implantation     method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method     (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter,     parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will     be implanted from up to 4 active sites, coordinated by a single lead investigator.      Patients who have had a successful SCS trial and are indicated for permanent implantation     will be approached to participate in this study prior to permanent implantation. Patients     will be recruited and enrolled by physicians at any one of the involved sites. Each     Investigator will only use one method (awake or non-awake) according to his/her typical     practice. Patients will receive treatment from their enrolling physician.   "
76499|NCT02284529|"     Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin),     fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ     colorectal cancer.      Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia)     in the end of study.      Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea,     diarrhea vomiting over the 12 weeks.      Safety will be evaluated including vital signs are recorded at all visits.   "
76500|NCT02284516|"     Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent     history of artificial tear use.   "
76501|NCT02284503|"     This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring     efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.   "
76502|NCT02284490|"     This phase II trial is studying how well pemetrexed disodium works in treating patients with     Lung Adenocarcinoma With Brain Metastases   "
76513|NCT02284347|"     This is a prospective, non-randomized, single-arm study designed to assess the safety and     device performance of the NuVent navigation-guided balloon system for use in subjects with     scarred, granulated, or previously surgically altered tissue (revision).   "
76524|NCT02284191|"     This study aims to investigate the effect of early CTCA in patients with suspected or     confirmed Acute Coronary Syndrome (ACS) presenting to the Emergency Department (ED) or     Medical Assessment Unit (MAU), upon interventions, event rates and health care costs in a     pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention.     The primary objective will be to investigate the effect of the intervention on the proportion     of patients with all-cause death or recurrent non-fatal type 1 or type 4b myocardial     infarction (MI) at one year.   "
76503|NCT02284477|"     -  Phthalate is an endocrine disrupting chemical, which works as an anti-androgenic agent.        -  Phthalate is mainly used as PVC plasticizer and easily found in commonly used products          such as electronic device, paint, lubricant, surfactant, medical supplies, spray etc.          Especially, PVC blood bag used for blood transfusion have been reported to have high          level of phthalate concentration.        -  Previous studies reported that urinary concentration of phthalate metabolites and HOMA          (Homeostatic model assessment, indicator of insulin resistance) has positive          association.        -  Previous studies also reported negative associations between urinary phthalate          concentration and pulmonary function.        -  Exposure to phthalates occurs mainly through oral route. Food wrapping with phthalate          containing package material is expected to be one of the major contributor for phthalate          exposure.        -  In this present trial, the investigators are to examine whether increased phthalate          exposure by consuming beverage stored in PVC containing packing materials actually          effect insulin resistance, pulmonary function and epigenetic feature.        -  For this aim, the investigators will conduct a cross-over trial.   "
76504|NCT02284464|"     Steroids are one of the pillars of immunosuppression for kidney transplant patients but their     use is associated with a high rate of complications. Withdrawal of steroids reduces some     metabolic and cardiovascular complications, but it may increase the risk of acute rejection.     However, little is known about whether steroid withdrawal is associated with the generation     of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and clinical and     histological data. The aim of this study is to compare the incidence of de novo anti-HLA DSA     in stable kidney transplant patients after withdrawing the steroids 3 months after the     transplantation as compared with patients who continue with steroids. The hypothesis is that     steroid withdrawal will increase the presence of de novo anti-HLA DSA in stable kidney     transplant patients   "
76528|NCT02284139|"     The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated     in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal     cancer (CRC). Dermatological reactions can cause significant physical and psycho-social     discomfort to patients. In the present study, the investigators evaluated the effect of     epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).   "
76505|NCT02284451|"     The Centers for Disease Control and Prevention (CDC) recommends that all patients should     receive information about HIV/AIDS and HIV testing orally or in writing at every HIV testing     encounter. However, for busy emergency departments (EDs), delivering information orally is a     barrier to HIV testing, and written brochures likely are not useful for those with lower     health or general literacy. Videos might be as or more efficacious than orally-delivered     information in improving HIV/AIDS and HIV testing knowledge, particularly for those with     lower health literacy skills. However, the resources required to show videos might limit     their use in EDs. Pictorial brochures are a promising alternative, but are of unknown     efficacy.      The objectives of this study are to: (1) determine if HIV/AIDS and HIV testing information     should be delivered by a video or pictorial brochure to emergency department (ED) patients to     improve short-term (in the ED) knowledge about HIV/AIDS and HIV testing; (2) determine if     longer-term retention (over 12 months) of HIV/AIDS and HIV testing knowledge is greater for     those who watch a video or review a pictorial brochure; (3) determine if short-term     improvement and longer-term retention in HIV/AIDS and HIV testing knowledge is better after     watching a video or reviewing a pictorial brochure for those with lower health literacy, and     if improvement and retention also varies by language spoken (English or Spanish); and (4) if     willingness to be tested again in one year is greater for those who watch the video or review     the pictorial brochure, and if this willingness also varies by health literacy level and     language spoken.   "
76506|NCT02284438|"     Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding     formation and structure of the biofilm formed on those ETTs.      Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be     examined.      Findings from electron microscopy (EM) and microbiology will be analyzed and compared in     respect to the three materials.   "
76507|NCT02284425|"     This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety     and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.   "
76508|NCT02284412|"     The use of neuromuscular blocking agents (NMBAs) is still associated with postoperative     pulmonary complications. The investigators rely on acceleromyography (AMG) of a peripheral     nerve/muscle to assess the patients' breathing capability at the end of surgery. It is     possible that respiratory complications after surgery (e.g. desaturation and atelectasis) are     related to the lack of diaphragm activity.      A previous trial by our study group links the use of sugammadex, a novel selective relaxant     binding agent (SRBA) for reversal of neuromuscular blockade, to an increase in diaphragm     electrical activity, compared to reversal with neostigmine. Our hypothesis is that by making     nicotinergic acetylcholine receptors free from rocuronium in the diaphragmatic neuromuscular     junctions, instead of increasing the amount of acetylcholine (like neostigmine does),     sugammadex will result in a better neuromuscular coupling. This may have its subsequent     effects on the central control of breathing, influencing the balance between intercostal and     diaphragm activity.      The investigators now propose a study in rats, where the investigators will use Functional     Respiratory Imaging (FRI, property of FluidDA n.v., Groeningenlei 132, B-2550 Kontich) to     assess regional lung ventilation after sugammadex, neostigmine or spontaneous reversal. The     images obtained through micro-CT scans allow us to accurately reconstruct airway morphology     in the free-breathing rat. It will provide us with new insights into breathing physiology     after reversal of neuromuscular blockade.   "
76509|NCT02284399|"     Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the     Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be     retrospectively gathered and an analysis of the impact and prevalence of NIPT. This will be     compared to a control group of pregnant women in those same practices undergoing prenatal     testing during the months of January 2010-July 2010.   "
76510|NCT02284386|"     This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic     (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary     unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve     block (SNB) and EXPAREL local infiltration into the surgical site.   "
76514|NCT02284334|"     The investigators are conducting a research study on nutrition in mitochondrial disease. The     investigators are interested in the kind of carbohydrates that people eat. Carbohydrates are     an important source of energy. Certain kinds of carbohydrates tend to raise blood sugar more     in healthy people, and others tend to raise blood sugar less in healthy people. The     investigators would like to know if by eating the right type of carbohydrate, people with     mitochondrial disease can avoid high lactate levels, high blood sugar levels, and, later, low     blood sugars.      In this study, this question will be answered by finding out how people with mitochondrial     disease respond to two different test meals containing different kinds of carbohydrates.     Neither participants nor the investigators will know which kind of test meal participants are     eating.   "
76561|NCT02283710|"     This randomized double blind clinical trial was performed in patients with non-alcoholic     fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle     modification plus Pentoxifylline groups. Liver function tests, metabolic profile and     anthropometric measurements were checked at baseline and six months later.   "
76516|NCT02284295|"     The objective of this study is to investigate molecular, cytological and genetic features of     occupational chronic obstructive pulmonary disease (COPD) in conditions of different     occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and     standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar     lavage fluid and association of single nucleotide polymorphisms (SNPs) rs1800470 transforming     growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene,     rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3     (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic     aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and     phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein     (hsCRP) and tumor necrosis factor alpha (TNF α) serum concentration, in different     occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying     disease development and progression are different due to environmental risk factor that     reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic     susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore     COPD can be subdivided into ecological phenotypes according to environmental risk factor.   "
76517|NCT02284282|"     The objective of this study is to determine if a single spinal shot of morphine can decrease     post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker     recovery after surgery.   "
76518|NCT02284269|"     The purpose of this study is to integrate the post-marketing surveillances data (Specified     use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in     Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical     practice conditions.      In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are     enrolled. A total of 18000 patients are assessed in the meta-analysis.   "
76519|NCT02284256|"     The primary objective of the study is to demonstrate the non-inferiority or superiority of     Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding     with conventional surgical techniques is ineffective or impractical.   "
76520|NCT02284243|"     The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative     Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over     the first 48 hours (SPID48) in subjects with acute moderate to severe pain following     unilateral bunionectomy.   "
76521|NCT02284230|"     The present study will examine the effects of liraglutide treatment during 26 weeks on     several cardiovascular risk factors in patients with prediabetes and end-stage renal disease     (ESRD). The primary objective is to determine the efficacy of the treatment on glucose     tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives     include various clinical and biochemical cardiovascular and safety parameters.      We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic     patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate     other cardiovascular risk factors.   "
76522|NCT02284217|"     Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.     HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's     head. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and     accurately monitor ICP with minimal discomfort to patients, and provide information about     normal or elevated ICP levels to the physicians.      The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive     ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)   "
76523|NCT02284204|"     There is still extensive debate on the best method of controlling the behavior of preschool     children during dental treatment. Protective stabilization, moderate sedation and general     anesthesia are advanced behavior control techniques indicated for the dental treatment of     early childhood caries and offer advantages and disadvantages during the procedure or     immediately after. Many children with early childhood caries require invasive dental     treatment. According to the final report of a large epidemiological survey on the oral     condition of Brazilians, five-year-old children had an average of 2.43 primary teeth with     caries and fewer than 20% of these had been treated in 2010. This disease also remains a     public health problem in most developed countries; 19.5% of 2-5-year-old American children     have untreated cavities.      There is, however, a lack of the ideal sedative. Such drugs must, on the one hand, control     the behavior of integral form, provide amnesia, minimizing physical discomfort, distress and     pain, and, on the other, safeguard security, with minimal effect on the cardio-respiratory     function, minimizing the occurrence of adverse events, as well as allowing the return of the     patient to a State that allows high safely. The investigators thus performed this prospective     study with the aim to assess the occurrence of adverse events during dental treatment and in     the first 24 hours after sedation with midazolam, ketamine and sevoflurane in children aged     four to six years. Our hypothesis was that no differences in adverse events among different     association of drugs could be found.   "
76648|NCT02282670|"     This is a multicenter, active-controlled, randomized, double-blinded, paralleled group     clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the     non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic     gastritis.   "
76525|NCT02284178|"     Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is     often associated with complications, such as infection and lung injury. Leakage of secretions     around the breathing tube (microaspiration) is a major factor leading to complications. The     investigators propose that a standardized, enhanced oral suction protocol will be effective     in reducing microaspiration and harms associated with mechanical ventilation. The     investigators hypothesize that those randomized to the enhanced oral suction protocol will     have less microaspiration and other ventilator-associated conditions than those in the usual     care, standard suction group.   "
78989|NCT02251938|"     The objective of this extension study is to evaluate the long-term safety of treatment with     DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye     who have participated in the SAKURA development program.   "
76529|NCT02284126|"     This study is a collaboration between NYP-Columbia and NYP-Cornell that seeks to evaluate the     use of topical vancomycin and its reduction on surgical site infection (SSI) in neurosurgical     procedures. Adult patients undergoing neurosurgery at either institution will be eligible for     participation in this randomized control trial. Patients randomized to the treatment group     will receive 2g of vancomycin applied as a powder or paste to the wound site and/or bone     flap. Subjects in the control group will receive the current standard of care without topical     vancomycin. All subjects will undergo swabbing of the anterior nares and the surgical site     prior to surgery, once 10-14 days following the operation and 90 days following the     operation. The primary outcome measure will be surgical site infection, assessed daily     throughout the hospital stay, at the first follow-up visit, and by telephone at 30 days.     Secondary outcomes will include length of hospital stay, length of intensive care stay, rate     of reoperation and patient mortality. In addition, systemic vancomycin levels will be     assessed at 6 hours and 24 hours postoperatively in each patient. Patients who have an     external ventricular drain in place will have vancomycin levels assessed daily. In patients     who have cranial drains placed, vancomycin concentrations will be analyzed from daily in     wound drainage. Skin and nasal flora will be analyzed to assess the impact of topical     vancomycin on the patient microbiome. Although there has been a decrease in the incidence of     infections following craniotomy secondary to prophylactic intravenous antibiotics, proper     sterile techniques, and other interventions, SSIs continue to significantly impact morbidity,     mortality, and cost burden. Although never studied in neurosurgical procedures other than     instrumented spine, the application of topical vancomycin to the surgical site prior to wound     closure has demonstrated a reduction in SSIs in spine, cardiac and ophthalmologic procedures.     The benefits of using prophylactic vancomycin topically, as opposed to intravenously, include     reduced systemic levels of the drug, and therefore, a decreased probability of adverse events     related to the drug, such as inducing resistance among native flora. The investigators     propose a randomized control trial to evaluate the effectiveness of topical vancomycin in     reducing SSIs rates following neurosurgical procedures.   "
76530|NCT02284113|"     This study will evaluate the iovera° device in treating pain associated with total knee     arthroplasty (TKA). This study will also assess if overall pain medication is reduced     following TKA and will investigate the relationship between patients treated with the iovera°     device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.   "
76531|NCT02284100|"     The relationship between human beings and animals, especially dogs, has existed for thousands     of years. Historically, animals have held an important role in this relationship as they     provide company, stimulus and motivation. Animals are excellent company, since their     visitation they do not discriminate or segregate any person, that is, they are free of     prejudice.      In spite of the long-lasting presence of companion animals in human life, the idea that     interaction with animals may exert a positive effect on human health is rather recent.      The American Veterinary Medical Association classifies therapeutic animal assisted     interventions (AAI) into three categories: animal assisted activities (AAA) that utilize     companion animals; animal assisted therapy (AAT) that utilizes therapy animals and service     animal programs (SAP) that utilize service animals. AAT in particular, is a goal-directed     intervention in which an animal that meets specific criteria is an integral part of the     treatment process. AAT is technically defined as the use of trained animals by trained health     professionals to facilitate specific, measurable goals for individual patients for whom there     is documentation of progress .      Interest in AAT has been fueled by studies supporting the many health benefits. AAT has     proven a useful adjunct in a variety of settings including mental health facilities, nursing     homes and hospitals where most studies have been performed with adult patients with variable     interventions, goals, patient characteristic and patient needs. In these studies, AAT     resulted in significant reductions in anxiety, agitation and fear. In children, AAT dogs     decreased distress during painful medical procedures, promoted calmness in children with     post-traumatic stress disorders and increased attention and positive behaviors in children     with pervasive developmental disorders.      Surgical procedures and hospitalization can be stressful for both children and their parents     and they are associated with pain, helplessness, fear and boredom. AAT has been shown to     facilitate a child's ability to cope with hospitalization, but to date, no studies on AAT     benefits in pediatric surgery have been reported.      The purpose of this study was to better understand the effects of an AAT program on     neurological, cardiovascular and endocrinological responses to stress and pain in the     immediate post-operative period in children undergoing surgical procedures.   "
76533|NCT02284074|"     The purpose of this study is to develop a nasal challenge model that causes a mild degree of     inflammation, without causing any pain or symptoms, but that allows us to measure a variety     of proteins in nasal secretions which causes inflammation in the nose. The nasal challenge     model involves spraying the nostrils in the form of a fine mist with 4 different doses (1,     10, 30 and 100µg per nostril) of lipopolysaccharide (LPS) including a placebo. LPS is a type     of protein which has been carefully purified from the outer cell wall of certain bacteria, is     sterile and does not contain live bacteria, and will not cause infection.      The investigators will measure any inflammation in the nose by looking at cells collected by     washing the inside of the nose (nasal lavage) and placing small strips of paper in the nasal     cavity. The paper absorbs the nasal fluid and the chemicals produced during inflammation and     can be extracted from the paper and analysed in the laboratory. The investigators will also     be collecting a small amount of nasal epithelium taken by way of a nasal scrape; this is done     by using a Rhinoprobe, a small plastic curette which is used to scrape a small piece of     lining of the nose. The investigators hope that information obtained from this study will be     used in future studies that will test new study drugs designed to treat diseases of the     airways and lungs ( like asthma and chronic obstructive pulmonary disease (COPD) and hay     fever.   "
76622|NCT02283008|"     The evidence for poor inhaler technique is both well established and observed worldwide. What     is unclear from the evidence is why individuals demonstrate poor technique, despite the     majority admitting to having previously had instruction on inhaler technique. The primary     research question is 'Will there be a difference between post education inhaler technique     scores when comparing structured education against informal education?'      To try and establish why individuals use inhalers incorrectly a semi structured interview is     proposed   "
76773|NCT02280928|"     The purpose of this study is to (1) develop and test the effectiveness of home-based     interventions on dual-task performance in older adults; and (2) determine the     generalizability of the four trainings (i.e. single-task motor training, single-task     cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive     trainings) to novel tasks.   "
76917|NCT02279043|"     This study will look at women's social communication about IUDs (intrauterine devices) and     their attitudes and behavior related to IUD use. The researchers will design an online     community where women can talk to each other about their experiences with birth control. We     will examine whether social exposure to IUD users in this setting is associated with change     in attitudes and behavior among women who have never had an IUD.   "
76534|NCT02284061|"     Context: Sport and physical activity during and after cancer treatment can improve fitness     and social inclusion in adults. In children, although early studies show interesting results,     conclusive data are lacking. A preliminary evaluation conducted in a dozen children following     a physical training program showed a significant improvement in endurance, muscle tone,     overall self-esteem, sports skills and self-perceived strength. The investigators then want     to evaluate the health of a group of children during treat cancer that physical activities     adapted compared to children who did not practice.      Objective: Measuring the impact of physical activity program on health of children and     adolescents with cancer with improved physical, psychological health, social reintegration     and reduced time hospitalization.      Method and Design: The study plans to include 90 children from the pediatric hematology -     oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18     months.      This is a randomized controlled open trial open with a stratified distribution. Children will     be randomized between two arms - Arm A (Experimental - Immediate Program): the child follows     the physical activity program for a period of 18 months, as soon as his medical condition     permits. - Arm B (Control - Delayed Program): the child does not participate to the program     during the first 6 months, and he joins the delayed program late after 6 months. Each child     integrates the physical program for a period of one year.      Regardless of the randomization arm, the child performs the initial tests, the intermediate     tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be     performed at 3 and 9 months.      The physical activity program includes a minimum of 30 days of activities per 6 months     (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.      The investigators aim at demonstrating a difference of 50 meters on the total walked distance     during the endurance test in the experimental group as compared to the control group after 6     months of program.   "
76535|NCT02284048|"     This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow     reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with     MVA   "
76536|NCT02284035|"     A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety,     tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when     replacing standard combination therapy in HIV-infected patients with prolonged virological     suppression   "
76537|NCT02284022|"     the objective of this protocol is evaluate the safety and tolerance of a communication system     for severely disable patients with myopathies. The system analyses the brain electric     activity in real time and converts it into digital commands for a spelling device, which is     refered to as the P300 speller in the scientific literature. The secondary objective is to     compare the performance of such tool with a more traditional assistive technology for the     communication of severely disabled patients : scanner systems.   "
76538|NCT02284009|"     This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre     study of 52 weeks treatment duration. The primary objective is to evaluate the efficacy(on     endogenous insulin secretion), safety and tolerability of weekly albiglutide (a glucagon-like     peptide-1 receptor (GLP-1R) agonist) versus placebo when added to insulin therapy in subjects     with new-onset type 1 diabetes mellitus (NOT1DM) and residual insulin production..     Approximately 68 eligible subjects will be randomised in a 3:1 ratio such that 51 subjects     receive albiglutide 30 milligram (mg) once weekly (with increase to 50 mg once weekly at Week     6 if the 30-mg weekly dose is tolerated) added-on to insulin therapy and 17 subjects receive     placebo once weekly added-on to insulin therapy. The total duration of a subject's     participation will be approximately 72 weeks (up to 8 weeks of Screening, 52 weeks of     treatment and 12 weeks of Post-treatment Follow-up)   "
76539|NCT02283996|"     The purpose of this study is to identify individuals 18 or older who have diagnostic     presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of     physical therapy and steroid injections compared with steroid injections followed by watchful     waiting. This prospective study will be used to determine whether there is a significant     impact on patient outcome and whether the additional financial burden is justified. There are     no experimental interventions for this study. The use of physical therapy, oral and     parenteral corticosteroids, and watchful waiting are offered following the standard of care     for adhesive capsulitis. Our hypothesis is that patients will not have a significant     difference in outcome between the two study arms. One group will undergo regular physical     therapy with corticosteroid injections (Arm 1) and the other will have steroid injections     during the inflammatory phase only and then be regularly observed (Arm 2). We also     hypothesize there will be a significant financial burden associated with the PT arm that is     not justified with the possibility of increased symptom reports in that arm.   "
76540|NCT02283983|"     For the specific patient population studied receiving 5-Fluorouracil, epirubicin and     cyclophosphamide - Docetaxel sequence (cumulative dose <300 mg / m2), using a cryoprotection     has never been assessed.      The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well     established in this population (breast cancer in the adjuvant setting) and is based solely on     a publication (Scotté) that does not contain the same therapeutic modalities (dose     significantly higher). The few studies available have heterogeneous populations,     nonrandomized, retrospective or with a small sample.      By extension to what has been observed with higher cumulative doses of docetaxel, some teams     offer mittens and booties chilled to their patients, a practice that is not the subject of a     national consensus.      The investigators wish to accurately assess the effectiveness of mittens and slippers     chilled, their tolerance and their observance because of weak data on this specific     population in the literature.   "
76541|NCT02283970|"     Prospective longitudinal study on four small groups of surgical patients affected by: BAV     with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with     isolated stenosis in over 60 year-old patients.      The aim of the study is to select homogeneous small groups of surgical patients with the same     subtype of BAV and same aortic behaviour and identify markers/predictors of     favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more     likely to be considered at high risk for aortic degeneration.   "
76542|NCT02283957|"     Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection     study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo     injected into the intermetatarsal space around a Morton's neuroma. The injection of study     medication will be administered by ultrasound-guided needle placement following ankle block     anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects will     return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments.   "
76691|NCT02282111|"     This is a single-blinded randomized control trial trying to compare the effectiveness of     diagnosis between two techniques employed in tissue sampling for subepithelial tumors (SETs)     of the gastrointestinal tract. Over 2 years, patients having SET will be randomized to either     get the EUS-guided core needle biopsy (EUS-CNB) or EUS-guided single-incision with needle     knife (SINK) technique. This is of grave importance because the diagnosis of the myriad types     of SETs is made histologically requiring a good sample.   "
76543|NCT02283944|"     The proposed project aims to develop novel electrochemotherapeutic treatment of glioblastoma     multiforme (GBM). Standard treatment has limited effect on survival and quality of life.     Electrochemotherapy is a novel and promising treatment, which has demonstrated convincing     results in the treatment of various types of carcinoma. The treatment is based on a     combination of electrical current stimulation of tumor cells and simultaneous administration     of chemotherapeutic drugs. Electrochemotherapy works by inducing an electrical current     between implanted electrodes in the tumor tissue, causing electroporation of the cancer cell     membranes, and thereby increasing the cellular permeability and drug uptake.     Electrochemotherapy has proven to be an efficient way of considerably increasing the potency     of the chemotherapeutic drug bleomycin in malignant cells in skin tumors and carcinoma     metastases, and thereby increasing cytotoxicity of the drug locally in the tumor tissue. This     allows for treatment with lower doses of chemotherapeutic drugs and more defined, local area     of effect, thus decreasing systemic effects. The investigators propose to use a novel     non-invasive and safe technique called focused transcranial magnetic stimulation (focused     TMS) to induce electrical current in the tumor tissue. TMS is a safe and widely implemented     technology used to treat multiple neurological diseases such as pain, depression and stroke.     Studies have shown that effective electroporation of cell membranes can be obtained using     induction of electromagnetic fields in a cell suspension, and new focused TMS further enables     focused treatment of selected brain regions without surgical intervention and, thereby     focusing chemotherapeutic treatment to pathological tissue and avoiding surgery related brain     tissue damage. Additionally, TMS transiently increases blood-brain barrier permeability,     theoretically allowing increased uptake of chemotherapeutic drugs in the target area. This     addresses a significant challenge in the treatment of brain cancer, as most cytotoxic drugs     have fairly limited ability to pass the blood brain barrier.      The intention of this research project is to investigate the therapeutic potential of focused     TMS as an alternative non-invasive source of current induction and thereby means to treat     several types of brain cancer with electrochemotherapy.   "
76544|NCT02283931|"     There is currently little information regarding the hemodynamic differences in uterine     displacement techniques. Previous studies examining the hemodynamic effects of uterine     displacement maneuvers have focused on incidence of hypotension and use of ephedrine.      Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are     becoming popular techniques in anesthesiology because they can provide noninvasive, valid,     and precise hemodynamic data.There has been no study specifically examining the hemodynamic     differences between the uterine displacement techniques using NICOM or TTE. While all three     uterine displacement techniques are recommended, whether one technique may maximize maternal     cardiac output is currently unknown.   "
76545|NCT02283918|"     The primary objective of the study is to develop MS patient-matched healthy population norms     for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of     the United States (US), France, and Italy.   "
76546|NCT02283905|"     All patients with pulmonary blastomycosis requiring mechanical ventilation will have their     blood concentrations measured for the antifungal drugs, amphotericin-B and voriconazole; as     well as an analysis of the susceptibility of their infecting species of blastomyces. This     information will then be analyzed relative to their rate of clinical recovery from this     serious fungal infection.   "
76547|NCT02283892|"     This is a randomized clinical trial that evaluates the impact of using an internet-based     checklist for systematic assessment of patients reporting respiratory complaints with the     conventional assessment, without using the checklist.   "
76548|NCT02283879|"     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord     mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.   "
76549|NCT02283866|"     Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern     anesthesia. The purpose of this study is to compare two methods of administering desflurane,     an volatile anesthetic during balanced anesthesia. The investigators hypothesized that     administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia     will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth     than administering desflurane according to the patient's BIS (bispectral index) value.   "
76550|NCT02283853|"     Part 1 main objectives of study 109MS306 (NCT02283853) are as follows: To evaluate the     safety, tolerability, and effect on the disease course of BG00012 (dimethyl fumarate) in     pediatric participants with RRMS, as compared with a disease-modifying treatment; To assess     pharmacokinetic (PK) and pharmacodynamic (PD) parameters in a representative subset of     pediatric participants; and To assess health outcomes and evolution of disability. Part 2     primary objective is to evaluate the long-term safety of BG00012 in pediatric participants     who completed Part 1 of Study 109MS306 (NCT02283853).   "
76551|NCT02283840|"     Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover     design   "
76552|NCT02283827|"     Single centre, open-label, multiple doses, two parallel study groups each receiving two     formulations in a one-sequence design   "
76553|NCT02283814|"     Single centre, open-label, multiple doses, one-sequence design study in two parallel groups     of healthy volunteers   "
76554|NCT02283801|"     Single centre, open-label, multiple doses, one-sequence design study in two parallel groups     of healthy volunteers   "
76555|NCT02283788|"     A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period     crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization     in healthy adult men and women   "
76556|NCT02283775|"     Primary Objective:      Safety      Secondary Objective:      Efficacy, Pharmacokinetics (PK)   "
76557|NCT02283762|"     To investigate if Riociguat is effective in the treatment of systemic sclerosis   "
76558|NCT02283749|"     In this study patient's will receive the medicine Xofigo which is a radioactive drug that is     FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously     been tested to treat lung cancer that has spread to the bones. Your doctors are studying the     effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones.   "
76559|NCT02283736|"     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of     Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root     planning (SRP).      Material and methods: Thirty six chronic periodontitis patients will be recruited and     monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after     therapy. All patients will receive scaling and root planning and randomly will be assigned     over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The     tablets will be used once per day during 3 months.   "
76560|NCT02283723|"     TAPESTRY is a delayed intervention pragmatic randomized control trial promoting     interprofessional team collaboration, facilitating connection to the community through system     navigation and trained community volunteers, enhancing communication and improving care     through the use of technology to better understand and assist older adult patients in     achieving their health goals and to enable them to have optimal aging.   "
76562|NCT02283697|"     High salt diet increases risk of development of hypertension. In hypertensive patients, low     salt diet decreases blood pressure. Not surprisingly public health authorities endorse low     salt diet in hypertensive patients. But, surprisingly, average salt intake among adults in     Canada remains stubbornly high. Low effectiveness of fast counselling by physicians and     nurses on dietary salt is partly the culprit. Methods used in successful clinical trials (eg.     provision of meals, community cooking sessions, many hours of counselling by dieticians)     cannot be used in routine clinical practice. Hence the investigators propose a study on a     pragmatic dietary counselling method suitable for clinical practice.      Hypertensive patients will be randomized to receive standard care (which includes counselling     by the usual healthcare team, including doctors and nurses) or to receive additional     counselling from a registered dietician. This counselling will include two components: a one     hour counselling session, and 4, once-weekly telephone calls.      Effectiveness of this counselling will be measured by checking sodium in the urine from a 24     hour collection (which is a measure of dietary salt intake) at baseline and at 4 weeks. In     addition, the investigators will also measure urinary sodium at 1 year, to assess if this     effect of counselling persists over a longer time.   "
76563|NCT02283684|"     With a growing body of knowledge on the promising advancements and recent clinical data of     the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world     of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser     technology.      In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS)     180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small     to moderate sized BPH in a prospective randomized trial.   "
76564|NCT02283671|"     First in human study to assess the tolerability and safety profile of treatment with     dendritic cell in patients with multiple sclerosis or neuromyelitis optica.   "
76565|NCT02283658|"     This pilot, phase II trial studies how well everolimus and letrozole work in treating     patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal cavity     cancer that has come back. Everolimus and letrozole may stop the growth of tumor cells by     blocking some the enzymes needed for cell growth.   "
76566|NCT02283645|"     The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for     chest hair enhancement.   "
76567|NCT02283632|"     This is a single site trial to assess metabolic effects in subjects after a Jejunal Diversion     procedure was performed.   "
76568|NCT02283619|"     Purpose of the study:      The goal of this study is to evaluate the relationship of electrocardiogram (ECG) findings     with clinical outcomes in a cohort of patients with left bundle branch block (LBBB) who are     being evaluated for acute coronary syndrome (ACS) in the Emergency Department (ED).      Background and significance:      The significance of specific ECG findings in patients with LBBB being evaluated for ACS has     been inadequately studied, and this gap in knowledge is a barrier to optimal management of     this population. Due to the speed, availability, low cost, and non-invasive nature of the     ECG, it would be ideal to identify ECG characteristics that help to risk stratify these     patients in order to inform clinical decision-making, reduce unnecessary invasive testing,     and conserve resources.      Methods:      In this prospective observational study the investigators will identify a consecutive series     of adult patients with LBBB presenting to the ED with suspicion of ACS. The investigators     will collect data including demographics, cardiac risk factors, initial ECG measurements, lab     and radiographic results, procedure results, and clinical outcomes such as 30-day death or     myocardial infarction (MI). The investigators will analyze the data using a cohort study     design to calculate odds ratios between ECG characteristics and the outcomes of interest.   "
76569|NCT02283606|"     The investigators aim to measure sonoelastographically the elasticity of the uterine cervix     in pregnant patients at term before induction of labor and compare between patients with     successful and failed inductions.   "
76570|NCT02283593|"     The purpose of this study is to observe and evaluate the use of a relapse prevention program     over time among internet help-seekers. Participants are recruited via a nationally known     portal for assisting anonymous individuals with changing their problematic alcohol use in a     healthier direction (alkoholhjalpen.se). The intervention offered lasts 10 weeks and includes     7 relapse prevention modules, with a three-week pause between the 6th and 7th modules.     Baseline data are collected regarding substance use and psychosocial health and follow-up     takes place 10 weeks after recruitment. The study is observational.   "
76571|NCT02283580|"     Recent work have shown that low load, high-repetitive single limb resistance training, if     compared to a control, can increase limb muscle function and functional exercise capacity in     patients with chronic obstructive pulmonary disease (COPD) while avoiding the occurrence of     limiting exertional symptoms. However, no comparison to another exercise regimen have been     performed. In addition neither the intramuscular nor the mechanism of this exercise regimen     have been investigated and represents the aim of the proposed project. We will in a     prospective, assessor-blind; block randomized controlled, parallel-group trial compare     single-limb to two-limb low load, high-repetitive resistance training in patients with severe     and very severe COPD      The research hypothesizes are:        -  that single-limb low-load high-repetitive resistance training will provide larger gain          in the 6-min walking distance than two-limb low-load high- repetitive resistance          training in patients with severe to very severe (stage III-IV) COPD.        -  that eight weeks of single limb training should also be associated with larger          physiological (increased muscle endurance, less muscle fatigue and deoxygenation) and          structural (muscle protein synthesis, fiber-type distribution and capillarization)          muscle adaptations to training, lower cardio- respiratory demand, as well a greater          increase in health-related quality of life in comparison to two-limbs simultaneous          training.      We will also compare the groups at baseline to investigate the acute effects and mechanisms     of single-limb to two-limb low load, high-repetitive resistance training, a comparison that     also will include healthy matched controls.      The research hypothesizes are:        -  that involving a large muscle mass during exercise (e.g., two-limb low load,          high-repetition resistance training) compared to involving a small muscle mass during          training (e.g., single limb low load, high-repetition resistance training) would lead to          larger restraints on the cardiorespiratory system in patients with severe to very severe          COPD. Conversely, single limb interventions should produce less dyspnea and more muscle          deoxygenation and fatigue than two-limb simultaneous exercise while healthy controls          will be able to perform both legs/arms exercise without a central constraint, and no          negative consequences on muscle fatigue or exercise stimulus.   "
76572|NCT02283567|"     The investigators aim to compare elasticity of the uterine cervix in singleton and twin     pregnancies of similar gestational age.   "
76716|NCT02281669|"     Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or     Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local     treatment available is intralesional (IL) Pentostam injection. During the current study the     investigators will monitor the adverse effects of this treatment and will follow up the     recovery of the lesions after Pentostam injections.   "
76774|NCT02280915|"     The study is designed to assess the bioavailability of iron from 4 different iron fortified     savoury food products   "
76573|NCT02283554|"     ABSTRACT:      Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which     releases various growth factors that promote tissue regeneration. Metformin (MF), a member of     biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit     a favourable effect on alveolar bone . Current study was designed to evaluate the combined     efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony     defects in chronic periodontitis (CP) subjects.      Methods: One hundred and twenty subjects with single defects were categorized into four     treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical     parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI),     probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were     recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic     intra-bony defect depth reduction was evaluated using computer-aided software at baseline and     9 months.   "
76574|NCT02283541|"     Falls are the leading cause of injury--‐related hospitalization and death in the elderly. As     such, fear of falling (FOF) is common among senior populations and often leads to activity     avoidance, social isolation, and reduced physical and mental health. Risk of falls is     particularly concerning for individuals suffering from late life depression (LLD) as both     depression and antidepressant treatment have been shown to be linked to gait impairments, a     strong predictor of fall risk. Currently, our team is conducting a study to examine the     effects of a non--‐pharmacological mind--‐body therapy commonly known as automatic     self--‐transcending meditation (ASTM) on autonomic and mood--‐related symptoms of LLD. This     study provides a timely opportunity to explore the intricate relationship between gait     disturbances and depression severity, as well as the potential benefits of ASTM intervention     on gait and FOF in seniors. Using a GAITRite® portable walkway, measures of stride length and     gait velocity will be obtained for seniors in the ASTM and control study arms every four     weeks for the duration of the ASTM program. The aim of this study is to answer the following     research questions: are gait impairments and depression severity correlated, and does ASTM     training have any effect on gait and FOF? The results of this study could not only provide     insight into the physical manifestations of depression but if ASTM training is found to     improve gait and reduce FOF then there is potential to use this mind--‐body meditation     technique as an adjunct therapy to reduce fall risk in seniors with LLD. Furthermore, future     research could expand upon these findings to examine the benefits of ASTM on gait impairments     secondary to other psychiatric illnesses.   "
76575|NCT02283528|"     Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth     together or using small titanium plates and screws to fix the fracture. With either technique     the upper and lower teeth are held together to ensure that the fracture is held in the     correct position during healing (for closed reduction) or while the plate and screws are     applied (for open reduction).      The teeth can be held together using Erich arch bars which are a type of braces that are     temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture     has healed even though the patient is able to open his mouth immediately after the surgery is     complete. The alternative to the traditional Erich arch bars is a relatively new type of arch     bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The     purpose of this study is to compare the two types of arch bars in terms of the speed with     which they can be applied as well as any difference in fracture healing   "
76576|NCT02283515|"     BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth     supporting tissues and alveolar bone that surround the tooth leading to formation of deepend     gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and     tooth loss. In the literature, several pharmacologic agents have been administration via     local delivery route, directly into diseased sites affirming greater improvement in     periodontal status. Therefore, present study was conducted to determine the clinical     effectiveness of subgingivally delivered 1.2% Rosuvastatin gel incorporated into an     methylcellulose vehicle for its controlled release into intrabony defect sites in adjunct to     scaling and root planing for treatment of chronic periodontitis patients.      MATERIAL AND METHODS: Sixty five patients were categorized into two treatment groups: group I     -SRP plus RSV, 1.2 mg and group II -SRP plus placebo. Clinical parameters included modified     sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL), were     recorded at baseline before SRP and at 1, 3, 4, and 6 months. Radiologic assessment of     intrabony defect (IBD) fill was analysed at baseline and after 6months using computer-aided     software.   "
76577|NCT02283502|"     The objectives of this program are to verify the safety and effectiveness of the MRgHIFU     system developed by the division of Medical Engineering of National Health Research     Institutes (NHRI)   "
76578|NCT02283489|"     This study will investigate the efficacy and safety of recombinant human endostatin     adenovirus combined with chemotherapy for advanced head and neck malignant tumors.   "
76579|NCT02283476|"     Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and     safety have been defined. However, the compliance is unsatisfactory since routine i.v of     Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous     intravenous infusion by using venous pump can improve the compliance.The comparative study in     efficacy and safety has not been done concerning continuous and routine i.v.In addition, what     patient can be benefited from Endostar have not been investigated. The biological markers,     such as circulating endothelial cells，CECs, will be explored in the study.   "
76580|NCT02283463|"     This study will test a suction-based method of engaging the cervix. Bioceptive has developed     a device that more gently and atraumatically attaches to the cervix with no bleeding. This     novel attachment mechanism may diminish pain and discomfort. Pre-clinical testing has been     performed on the device including testing on synthetic uterine models, human cadavers, and     human uteri immediately post-hysterectomy (Utah IRB # 00059096). Results from these efforts     have shown effective attachment to the cervix and the ability for the device to maintain     suction throughout a procedure atraumatically. This study proposes to introduce this minimal     risk device in a clinical setting to determine the response of women undergoing gynecologic     procedures.   "
76806|NCT02280486|"     This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy     and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes     inadequately controlled with metformin monotherapy.   "
76581|NCT02283450|"     Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated     cardiomyopathy patients with heart failure.      Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy (     cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from     May 2012 to April 2014. These 30 cases were treated under the recommendations of normal     diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the     experimental interferences were avoided and patients were divided into the experimental group     and the placebo group. The patients in experimental group received the relevant tests and     inspections before the beginning of experiment，signed the informed consent. Then the     investigators get the venous blood centrifugalization and cryopreservation. The patients take     the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the     investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep     blood specimens. Three and six month later，electrocardiogram and echocardiography were taken     and the determination of the NT - proBNP was done. The placebo group was followed up in the     same way.   "
76582|NCT02283437|"     This proposed randomized controlled trial will test the effectiveness of a problem-solving     based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia spectrum     disorders. A repeated-measures, three-group design will be used to evaluate and compare the     effects between two treatment groups(PSBBP and psycho-education group) and routine outpatient     service and family support(control group) for 129 randomly selected family caregivers of     outpatients with schizophrenia-spectrum disorders over a 12-month follow-up.   "
76583|NCT02283424|"     This is a randomized ,opened, prospective controlled trial of clinical effectiveness for     Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma     patients with epidermal growth factor receptor gene mutation   "
76584|NCT02283411|"     The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor     Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose     Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing     over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring     System - Professional Sensors will be worn by adult subjects over a 14-day wear period.      The primary objective is to characterize the Systems performance with respect to YSI     reference venous sample measurements. The device performance will be primarily evaluated in     terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in     reference to YSI.      Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse     Device Effects and Serious Adverse Device Effects experienced by study participants.      240 subjects will be enrolled and additional healthy subjects may also be enrolled in the     study as training subjects.   "
76585|NCT02283398|"     We aim to investigate whether RIPC (remote ischemic preconditioning) is effective in the TAVI     setting to reduce post-procedural myocardial damage and improve patient outcome. Accordingly,     we aim to investigate whether RIPC can be introduced as an integral part of the TAVI     procedure, in order to reduce post-procedural myocardial damage and potentially improve     patient outcome.   "
76586|NCT02283385|"     There is no current elder abuse service that systematically assesses and provides services to     address the mental health needs of older adult abuse victims. The proposed study will     investigate the efficacy of a skill-based, mental health intervention to help treat elder     abuse victims, bolster mental health outcomes, and improve detection of symptomatology in     future screenings.   "
76587|NCT02283372|"     A phase I study to evaluate safety of gemcitabine with nab-paclitaxel and concurrent IMRT for     locally advanced and borderline resectable pancreatic cancer. The goal of this study is to     evaluate if a chemotherapy regimen that provides superior systemic efficacy may be safely     delivered and enhance efficacy of tumor directed radiation therapy.   "
76588|NCT02283359|"     The main purpose of this study is to see whether the combination of selinexor (KPT-330) and     irinotecan can help people with esophageal or stomach cancer. Researchers also want to find     out if the combination of selinexor (KPT-330) and irinotecan is safe and tolerable.   "
76589|NCT02283346|"     The hypofractionated external radiation (EBRT) is a technique that radiation dose delivery     using higher daily fractions than those used routinely. In this way can cause more damage     tumor, especially in tissues that have a slower proliferation rate, as in the case of     prostate cancer. Furthermore, achieves a reduction in total treatment time and probably a     lesser chance of development of collateral in tissues of high multiplication rate as the     lining of the rectum and bladder effects.      With brachytherapy boost for high dose rate is achieved by administering a more intense dose     on the tumor and lower the sound around the region to be treated tissues, improving the     therapeutic window.      Treatment with retracted and fully ambulatory time, has potential benefit as early patient     return to usual activities and optimizing the flow of patients who require treatment with     radiotherapy. This prospective study aims to assess the results and the toxicity profile of     this treatment regimen retracted.   "
76597|NCT02283242|"     It is recognized that inflammation can be modulated by cholinergic stimulation and that     galantamine, an inhibitor of acetylcholinesterase enzyme with central nervous system action,     has showed an anti-inflammatory effect, reducing body weight, abdominal fat and improvement     in tissue insulin resistance in animal models. Galantamine is a safe drug that is used to     treat alzheimer disease.Galantamine treatments of patients with the metabolic syndrome may     represent a significant advance in management of this disease. This study aims to investigate     the effects of galantamine on inflammatory markers, as well as on abdominal visceral and     epicardial fat and oxidative stress in patients with metabolic syndrome. This is a pioneering     study that will include expert support. The enrolling of subjects will have continuous     monitoring throughout the period of treatment. The study is a double blind randomized     prospective study with 60 patients with metabolic syndrome, to be randomized at ratio of 1: 1     placebo and galantamine. The dose of galanthamine is the standard clinically approved (8 and     16 mg). The tracking method include metabolic analysis, inflammatory and oxidative stress     markers, hemodynamic evaluation with hear rate variability (sympatho vagal modulation)     before, during and after treatment. Computerized tomography assessment of visceral abdominal     and epicardial fat before and after treatment will be performed.   "
76807|NCT02280473|"     This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients     with dry eye disease.   "
76590|NCT02283333|"     The purpose of this study is to compare the efficacy of an experimental treatment (termed     BATE-G) for Prolonged Grief Disorder (PGD) in Veterans compared to the current, VA-approved     standard of care treatment. Currently, treatments for grief in Veterans remain understudied.     Our research group has recently completed pilot work on an innovative, technology-leveraged     treatment protocol for PGD that combines Behavioral Activation with Therapeutic Exposure     (BATE) and appears readily applicable to the Veteran and Military populations. Per the VA /     DoD Iraq War Clinician Guide, 2nd ed., the current standard of treatment is Cognitive     Restructuring and Supportive Grief Counseling.      The study will enroll 140 Veterans, aged 21 years and older, who served in any combat era.     All Veterans will meet criteria for PGD. There will be assessments at baseline, 1 week, 3     months, and 6 months post treatment. During the treatment phase, Veterans will undergo 7     weekly sessions of either BATE-G or standard treatment. Sessions 2-6 will be delivered via     televideo to the Veteran's home.      We hypothesize that BATE-G will be more effective than standard treatment in reducing     symptoms of PGD, both at post-treatment and follow-up. Moreover, BATE-G will be more     effective in reducing acute emotional distress and preventing long-term emotional distress in     terms of general depression and anxiety symptoms. BATE-G will result in increased frequency     of completed positively reinforcing, community-based events when compared to Cognitive     Restructuring and Supportive Grief Counseling. BATE-G will also result in greater     improvements in perceived social support and health.      Note: This project is the first evidence-based treatment for PGD in military populations,     thus addressing a significant service gap.   "
76591|NCT02283320|"     BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients     with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or     squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one     prior platinum-containing chemotherapy regimen.   "
76592|NCT02283307|"     The goal of this study is to validate that Dual Energy CT (DECT) urography when performed     with a 50% reduction in iodinated contrast dose results in a CT exam with equal or better     image quality and equal or better diagnostic capability compared to traditional Single Energy     CT (SECT) performed with a standard contrast dose.   "
76593|NCT02283294|"     The purpose of this study is to evaluate if Apixaban will decrease the complication of having     another stroke for people who have atrial fibrillation if initiated earlier than standard of     care.   "
76594|NCT02283281|"     Clinical evidence about the effects of cannabis in a perioperative setting or for the     management of acute pain is rather scarce, mostly consisting of case report-based opinions on     adverse events during or after general anesthesia after smoking cannabis, experimental pain     trials in healthy volunteers, and a few clinical trials using different drugs, dosages and     routes of administration. It is difficult to draw strong conclusions from the available     evidence, that may seem sometimes even contradictory, mainly due -the investigators believe-     to the many sources of variability in the study designs (e.g.: heterogeneity of the study     samples, underpowered, unblinding, lack of randomization, timing of the therapeutic     intervention, different experimental pain models, inclusion of different kind of surgical     pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that     cannabis and cannabinoids may have a beneficial role in the management of acute     post-operative pain and nausea, at least for a selected group of patients and through an     appropriate therapeutic intervention.      Therefore, it seems to us pertinent to carry out an investigation in order to re-evaluate the     issue of perioperative cannabis use through a sufficiently powered and controlled clinical     trial. Some of cannabis effects such as sedation, bronchodilation, dryness of respiratory     secretions, vein dilation, and increase of heart rater without producing hypertension, make     of it an attractive option for pre-medication; while its antiemetic properties and its     analgesic potential without causing respiratory depression may be profitable for the     post-operative period.      Nabiximols seem to be most suitable to our investigation. The co-administration of     tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic     benefits with an attenuation of adverse effects. The investigators expect to obtain less     sedation, milder high, lower incidence of anxiety, tachycardia, and hyperalgesia, as     compared with THC-only acute pain trials.   "
76596|NCT02283255|"     Introduction: Different variations of the Fontan operation has been used to treat complex     cardiac anomalies with a single functional ventricle. This procedure has substantially     improved quality of life and survival in patients with these complex cardiac anomalies.     However, the cardiovascular and pulmonary functioning as well as skeletal muscle alterations     that can explain the exercise intolerance in these patients is still poorly understood.      Objectives: 1) To evaluate effects of different exercise programs on adolescents and adults     with Fontan circulation.      Methods: A long-term randomized clinical study that will include 60 patients between 12 and     30 years, submitted to total cavopulmonary connection for at least 5 years post operative at     the Heart Institute, University of São Paulo Medical School. The patients will be divided     into four groups: 1) Exercise training with aerobic exercise + lower and upper limb strength     exercise (GTF-I); 2) Respiratory training with respiratory muscle exercise (GTF-II); 3)     Exercise training with aerobic exercise + lower and upper limb strength exercise +     Respiratory training with respiratory muscle exercise (GTF-III); and A non-exercise group as     control group (GNTF-IV). The patients will be revaluated after the 4-month period of     intervention.      Expected Outcomes: The investigators expect to demonstrate that exercise training and     respiratory training can substantially improve the cardiovascular and pulmonary responses and     skeletal muscle system in patients with univentricular circulation. In addition, the     investigators wil test the hypothesis that the effects of exercise training associated with     respiratory training on cardiovascular and pulmonary responses and skeletal muscle system may     be greater than exercise training or respiratory training alone.   "
76598|NCT02283229|"     Prospective randomized clinical interventional trial after birth in maternity ward, and     follow up to 8-9 years of age.      Hypothesis: Preventive handling and caring advices to parents of newborns decrease     craniofacial asymmetries (deformational plagiocephaly and torticollis). The minimum sample     size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a     power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and     appearances of occlusal defects are followed up to 9 years. 50 preterm infants can     participate without intervention.   "
76808|NCT02280460|"     To create a local registry for ECMO patients.   "
77166|NCT02275806|"     This is a prospective, single institution phase II study, whose primary objective is to     estimate the median and three year survival rate of non-small lung cancer patients with Stage     IIIA and IIIB intra-thoracic disease which is referred to as locally advanced non-small     cell lung cancer (NSCLC).   "
76918|NCT02279030|"     The purpose of this study is to assess if Single Photon Emission Computed Tomography (SPECT)     demonstrating cardiac innervation can be integrated into current electrophysiology voltage     mapping system and provide improved guidance for ablation of PVCs.   "
76599|NCT02283216|"     The purpose of the study is to investigate different stimulation parameters for a new     noninvasive approach for modulating the brain that could potentially be beneficial for     decreasing tinnitus perception. The new approach is called Multimodal Synchronization Therapy     (mSync). mSync uses a combination of acoustic stimulation played through headphones and low     levels of electrical current delivered via electrodes placed on the surface of different body     regions. The timing interval between the acoustic and body stimulation is varied in order to     cause different types of changes in the brain. In addition to acoustic and body stimulation,     noninvasive cortical stimulation will also be presented as part of mSync to attempt to     further modulate or decrease the tinnitus percept. Cortical stimulation will be performed by     placing a magnetic coil over a spot on the head and sending a brief magnetic pulse that can     travel through the skin and bone to create electrical current inside the head. For this     study, different body locations as well as specific timing intervals among acoustic, body,     and cortical stimulation will be investigated to identify appropriate parameters that can     modulate and potentially decrease tinnitus perception. Different mSync parameters will be     investigated across multiple testing sessions (up to 16 weekly sessions) and the tinnitus     percept will be closely monitored throughout the study.   "
76600|NCT02283203|"     The efficacy of intravenous paracetamol has never been compared with other drugs for the     management of fever due to infections. Available data come from clinical studies conducted in     healthy volunteers subject to experimental endotoxemia. The present study compares the     efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of     infectious origin.   "
76601|NCT02283190|"     Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6     doses MWF over a period of 2 weeks to 9 patients (as described below and in the following     schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation     studies including fibrinogen will be measured and reviewed before each asparaginase dose.     Fibrinogen (<100 mg/dL) can be replaced with cryoprecipitate before each dose at the     discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase     or direct bilirubin above normal range.   "
76602|NCT02283177|"     This pilot study is designed to evaluate the safety and tolerability of oral crenolanib     besylate given sequentially during standard induction and consolidation chemotherapy in     patients with newly diagnosed AML with FLT3 activating mutations.   "
76603|NCT02283164|"     The goal of this research is to evaluate the efficacy of an audit and feedback intervention     to improve personal protective equipment (PPE) use by nurses who handle hazardous drugs in     the ambulatory oncology setting.   "
76604|NCT02283151|"     The study was designed to investigate the effects of a very low carbohydrate diet (VLCD)     intervention on weight control in overweight/obese patients in China.All the subjects were     randomly assigned to experiment group and control group. The experimental group was given     individual instructions on how to follow the VLCD (very low carbohydrate diet). The control     group was given an energy-restricted diet.The energy-restricted diet (ER diet) was designed     in the traditional Chinese style with an initial target for a total energy intake of 1200     kcal/d (5021 kJ/d).   "
76605|NCT02283138|"     The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance     index in preterm fetuses and correlating the results with postnatal respiratory distress of     the preterm neonates.   "
76606|NCT02282098|"     The purpose of this study is to determine the feasibility of performing a randomized     controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at     reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).   "
76607|NCT02282085|"     This study compares aripiprazole once-monthly injection to standard of care oral     antipsychotic medication in non-adherent outpatients with schizophrenia to see which     treatment helps people take their medicine more regularly and have more positive outcomes.      It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole     once-monthly will be more likely to respond and have lower symptom severity over 3 months of     treatment than those receiving standard of care oral antipsychotics.   "
76608|NCT02282072|"     The purpose of this study is to verify efficacy and safety of a bilateral deep brain     stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid     addiction.   "
76609|NCT02282059|"     This study is a multi-center, prospective, non-interventional (NI) study evaluating the     safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced     or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with     progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in     China hospitals. Each subject will be followed up overall survival (OS) time or the date of     withdrawal and subjects who remain alive after study completion will have their OS time     censored on the last date known to be alive. Eligible subjects will be enrolled to receive at     least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen     (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated     until disease progress, unacceptable toxicity, withdrawal from the study at their own     request, or until the final analysis for the study is performed. The NI study will capture     observations that will be used for evaluating the safety profile of sunitinib, including:     subject demographics, medical history and medications. Safety assessments, treatment data and     any other laboratory examination results, which were done according to routine clinical     practice, will be collected at all visits.   "
76610|NCT02282046|"     This study is designed to understand the impact of glycemic control in patients with type 2     diabetes on dental implants under long-term function. It is hypothesized that poor glycemic     control will not have significant effects on implant-related outcomes over longer periods of     time.   "
76611|NCT02282033|"     The purpose of the study is to evaluate the safety and performance of the Moderato System by     implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who     also have hypertension, in order to reduce their blood pressure.   "
76919|NCT02279017|"     To assess the feasibility to translate an automated weight loss message intervention to a     weight loss clinic population.      Aim 1: To assess feasibility of translating the intervention in a clinic for patients who     recently completed a structured weight loss program.      Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months     through an automated intervention.   "
76613|NCT02282007|"     More and more people suffer from stress-related illness and ailments that can greatly affect     the individual's experienced quality of life and sense of coping since pain, physical, mental     and social functioning are closely linked. Many of these people will seek primary care for     help, and thus be referred to the Norwegian psychomotor physiotherapy (NPMP) performed by     physiotherapists in primary care.      Data shows that for the first three months of 2009, 42% of patients were referred to NPMP had     a musculoskeletal diagnosis as the first diagnosis, often in the form of long-term and     comprehensive pain problems. Many of the patients also had emotional difficulties, but     without being diagnosed with mental illness. 23% of patients who were referred to NPMP had a     psychiatric diagnosis as the first diagnosis. The full range of psychiatric diagnoses are     represented, but the majority of patients were treated for anxiety and depression.      The investigators want to let people who have had NPMP treatment to consider what effect the     treatment has given, measured by separate registrations of quality of life, pain, physical,     mental and social functioning.   "
76614|NCT02283112|"     This study aims to ensure that assays that measure drug concentrations are accurate and     precise in different matrices when quantified using high performance liquid chromatography     -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various     bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile     dysfunction agents. Samples will also be obtained from individuals not receiving these     medications for quality control purposes.   "
76615|NCT02283099|"     The study is designed to establish safety, tolerability and immunogenicity of rVSVΔG-ZEBOV-GP     (BPSC1001), an Ebola Virus Vaccine candidate (recombinant vesicular stomatitis virus (VSV)     expressing the envelope glycoprotein of Ebola Virus Zaire), investigated at three different     dose levels in 30 healthy adults in Germany. This study is part of the WHO led VEBCON     consortium that is aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001)     vaccine candidate to allow optimized rapid decisions on dose and safety.   "
76616|NCT02283086|"     DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted     from January 1, 2012-December 31, 2013.      SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.      PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and     randomized to receive feedback reporting or not.      INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized     group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients),     and yield (percentage of CTPEs positive for PE) beginning January 2013.   "
76617|NCT02283073|"     The main objective of the study is to design and validate the blood based PDx gene expression     assay for the early diagnosis of Parkinson's disease patients. Differential diagnosis     includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal     Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.   "
76618|NCT02283060|"     Atripla and Stribild are two FDA-Approved one pill a day combination antiretroviral     medications given for the treatment of HIV. Both drugs are reasonably well tolerated.     However, efavirenz, a component of Atripla, is known to cause mental side effects.      This proposal aims to assess whether a switch from Atripla to Stribild for 12 weeks will be     associated with reversal of sleep and cognitive disturbances. Demonstrating changes upon     withdrawal of drug and substitution of a drug regimen not known to have an impact on sleep     and cognition may represent the best option to determine whether use of efavirenz is     associated with effects on sleep and cognition beyond the immediate period following     initiation of drug.   "
76619|NCT02283047|"     Obesity and arterial hypertension (HTN) frequently coexist in the same patient. Moreover, the     concept that obesity and HTN can be additive in terms of cardiovascular rist is widely     accepted. Yet, clinical decision-making in obese patients is complicated by a surprising lack     of evidence on the relative importance of obesity and HTN treatment and its efficacy and     safety. Lifestyle interventions are the mainstay of obesity management programs and are also     advocated in the prevention and treatment of HTN. Physical exercise and diet are recommended     to prevent and control obesity and HTN. Aerobic exercise is firmly established as an     effective measure for lowering blood pressure and reducing cardiovascular risk. However,     there is no agreement about the optimal dose of frequency, intensity, duration and type of     exercise. Therefore, the aims of the study are: 1) to assess the changes in selected     parameters of blood pressure, cardiorespiratory fitness, body composition and biological     markers brought about by a period of 16-week of different aerobic exercise programs with     hypocaloric diet for overweight or obesity and primary hypertensive adults, and 2) to examine     the effect of six months detraining subsequent to intervention. Secondary objectives are to     examine the additional effect of the intervention on physical activity behavior and     health-related quality of life.   "
76620|NCT02283034|"     The aim of this study was to compare five CPR feedback devices to standard BLS in terms of     the quality of single rescuer pediatric resuscitation. Therefore, the investigators     hypothesis was that there would be no difference between CPR methods in terms of chest     compression quality parameters.   "
76621|NCT02283021|"     Calcium is an extremely important ion used in our body for many processes. One of its tasks     is to control gene expression. Cells intake calcium from their surroundings though special     calcium channels located on the surface membranes of the cells.      The great many studies on such calcium channels were performed on excitable cells such as     muscle, heart or neuronal cells, where the calcium ions are controlled by voltage.     Surprisingly, not much is known about the identity of calcium subunits in non-excitable cells     like epithelial cells (which compose most of the connective tissue in the body), liver cells,     lung cells, immune system cells, etc.      Recently, the investigators have shown that calcium channels from muscles are, in fact,     expressed in T cells of the immune system, where they are used for proliferation. The     investigators postulated that probably other cell types, especially cancerous cell types,     might be using these subunits similarly.      The aim of this study is to determine the identity and sequence of calcium subunits expressed     in non-small cell Lung Carcinoma (NSCLC), which accounts for 80% of the worldwide lung cancer     deaths.   "
76811|NCT02280421|"     ASP2151 is an experimental treatment for herpes. Patients undergoing organ and tissue     transplantation may be prescribed ciclosporin to suppress their immune system to give the     transplant an increased chance of not being rejected. A patient with a compromised immune     system is more susceptible to infections such as herpes, which will require treatment.   "
76623|NCT02282995|"     Background:      Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology of     functional dyspepsia is uncertain. Risk factors include genetics, gender, age, helicobacter     pylori infection, etc. However, few reported the association of genetic contribution to the     development of FD and mood disorder.      Indication:      Functional dyspepsia patients      Study center(s):      Prince of Wales Hospital, Hong Kong      Aims:        -  To evaluate genetic factors on development of functional dyspepsia & common mood          disorders        -  To evaluate genetic factors on the severity of function dyspepsia & mood disorders        -  To develop a diagnostic test for classification of functional dyspepsia by plasma          ghrelin and serotonin expression        -  To collect sleep data for future use        -  To save blood sample for future retrospective diagnostic or genetic examination      Study design:      Case-control cross sectional study      Number of subjects:      Total of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300 Controls     + 300 FDR)      Patient population:      Functional dyspepsia patients age 18-60      Duration of study:      1 May 2012 - 30 April 2013      Primary variable(s):      Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression      Secondary variable(s):      FD global symptom assessment and symptom scores      Number of visits: 1      Hypotheses:        -  Shared genetic factors contribute to the development of FD and common psychological          disorders        -  FD patients contribute to suppression of plasma ghrelin and serotonin expression          compared to healthy controls   "
76624|NCT02282982|"     This was a non-interventional, prospective, multi-center study with no control group designed     to assess the effectiveness of palivizumab in a population of infants at high-risk of serious     Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants     ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)).     Participants received immunoprophylaxis during the RSV season, defined as October 2014     through April 2015, in routine clinical settings throughout the Russian Federation.   "
76625|NCT02282969|"     Objectives:      This protocol addresses the first phase of a larger project funded by the Patient-Centered     Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer     screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted     for the larger, comparative study. In this initial development phase, our prototype patient     decision aid will be updated to reflect current guidelines about lung cancer screening. The     updated aid will then be pilot-tested in a new sample of patients. In addition, several of     the study measures will be refined and further developed in preparation for the larger study.      The specific aims of the measures and decision aid development phase of this project are as     follows:      Update the aid to reflect current screening guidelines and refine the aid via cognitive     testing with patients/smokers; and pilot test the updated aid for acceptability with     patients/smokers.      Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new     measure with patients/smokers, and evaluate the reliability of the new measure in a sample     patients/smokers.   "
76626|NCT02282956|"     Hallux surgery is known to be extremely painful. Standard pain therapy is treatment with     NSAID and opioid painkillers. Patients are frequently not-satisfied with this. Some     institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. But     this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all     surgeons. A single shot nerve block of the posterior tibial nerve is less invasive and could     be superior compared to standard pain treatment. A great variability of nerve supply of the     foot is well described. There are some hints that the posterior tibial nerve supplies the     first metatarsal bone and the first metatarsal joint. A nerve block could reduce     postoperative pain in hallux surgery. To assess the effectiveness of this investigated     measure, the requested morphine dose of a PCA pump will be used to verify the effectiveness     of the tibial nerve block.   "
76627|NCT02282943|"     The purpose of this study is to compare laser CO2 ablation/excision of Endometriosis (AFS     stages 1-3) with excision of endometriosis using the Ethicon Harmonic ACE device. Pain scores     at 6 months was the primary outcome, but secondary outcomes assessed pain scores at 1, 3 and     5 years as well as psychological state and quality of life.   "
76628|NCT02282930|"     This study is designed to answer whether patients with progressive IgA nephropathy, who     receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6     months is effective in inducing improvement in proteinuria and renal function.   "
76629|NCT02282917|"     This will be a multi-center, proof of concept phase 0 study to assess the suppression of     p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing     tumor resection. AR-42 is a small molecule which crosses the blood brain barrier (BBB) in     rodents, but the investigators are not certain yet if it will penetrate human VS. Meningiomas     are outside the BBB, but seem to be unusually resistant to all current medical treatments.     The primary endpoint of the bioactivity of suppression of p-AKT by AR-42 was selected as drug     activity seems more informative than bioavailability. Our preclinical data and others have     shown dose dependent suppression of p-AKT by AR-42 in both VS and meningiomas.   "
76630|NCT02282904|"     Background:      - Chronic Granulomatous Disease (CGD) causes immune system problems. Treatment is usually a     bone marrow transplant from a fully matched donor. Researchers want to try using partially     matched donors for patients who do not have a fully matched donor available. The researchers     will also use the drug cyclophosphamide to try to improve the outcomes when using a partially     matched donor.      Objective:      - To learn the effectiveness of using cyclophosphamide with a transplant from a partially     matched donor in treating CGD.      Eligibility:      - Recipients: age 2-65 with CGD with an ongoing infection that has not been cured by standard     treatment and no fully matched donor available in an appropriate timeframe.      Design:        -  Recipients will:             -  be admitted to the hospital 2 weeks before transplant.             -  be screened with blood and urine tests, breathing and heart health tests, X-rays,               and/or magnetic resonance imaging. They may have a bone marrow aspiration and               biopsy.        -  meet with a social worker and dentist.        -  get chemotherapy, radiation, and other medicines.        -  get an intravenous (IV) catheter in their chest.        -  have the transplant.        -  get more medicines and standard supportive care.        -  have blood drawn frequently.        -  have to stay in the Washington, D.C. area for 3 months post-transplant.        -  be followed closely for the first 6 months, and then less frequently for at least 5          years.   "
76631|NCT02282891|"     The purpose of this study is to compare the hemodynamic effects of a standardized induction     of general anesthesia with either propofol or ketofol in patients with physical status     classification ASA 3. The study will be a double blinded, randomized controlled trial (RCT)     with two arms of treatment groups. One arm will consist of induction of general anesthesia     using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine (ketofol) and the induction dose will     be 1.5mg/kg of propofol and 0.75mg/kg of ketamine; the second arm will consist of induction     of general anesthesia using propofol 2mg/kg. The primary outcome of the intervention will     consist of hemodynamic changes during the first 30 minutes after induction of general     anesthesia.   "
76632|NCT02282878|"     The purpose of this work is to investigate the influence of dietary salt intake on immune     function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests     the hypothesis that higher dietary salt intake will be associated with a higher frequency of     pathogenic Th17 cells and impaired function of protective regulatory T cells. If a     relationship between dietary salt intake and immune function is observed, this study will     also test: a) whether this relationship is unique to MS subjects or whether it is also     present in healthy controls, and b) whether healthier immune function can be restored by     restricting dietary salt intake.   "
76633|NCT02282865|"     Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system.     Anxiousness, which tend to result from the deficient action of parasympathetic nervous     system, likely to show low HRV. This study is to investigate the relationship between the     surgery-related anxiety and the HRV which is known to reflect the balance of autonomic     nervous system. Furthermore, this study also focuses on HRV's role as a predictor for     aggressive emergence behavior, which might also be considered as partially related to     imbalance of autonomic nervous system.   "
76634|NCT02282852|"     Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected     diseases of the small bowel. The procedure is safe and noninvasive, the main risk being     capsule retention occurring in approximately 2% of procedures. Other problems such as     incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric     emptying, slow small bowel transit, faulty equipment and poor bowel preparation.      Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime'     viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an     intramuscular prokinetic injection if this fails. This approach has disadvantages since an     intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly     used for this purpose, has a risk of acute dystonic reactions particularly in young patients.      Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the     capsule in the upper GI tract. We propose that this could be used, alongside positional     changes, to expedite capsule transit through the stomach thus improving completion rates and     avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled     study comparing a standard protocol for small bowel capsule endoscopy against a hand held     magnet and positional change protocol to enhance gastric emptying of the wireless capsule.   "
76635|NCT02282839|"     This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy     with/without chemotherapy due to head and neck cancers. Basic data will be recorded along     with tumor related variables. Then they will be divided randomly into study group and control     group. The study group will receive oral glutamine during radiotherapy while the control     group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading     system), pain status (visual analogue scale), quality of life questionnaires will also be     documented. The differences between the two groups will be analyzed.   "
76636|NCT02282826|"     Primary Objective:      To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and     subcutaneous (SC) doses in men and women with progressive multiple sclerosis.      Secondary Objectives:      To assess the following in men and women with progressive multiple sclerosis:        -  The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.        -  The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.        -  The PK parameters of GZ402668 after ascending single SC doses.        -  The PD of GZ402668 after ascending single SC doses.   "
76637|NCT02282813|"     This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or     CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in     reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in     stage 3 or 4 chronic kidney disease patients.   "
76638|NCT02282800|"     The study was to intended to visualize the nuclear localization of vitamin D receptor in oral     tissues of aggressive periodontitis patients to better understand the potential for receptor     in disease activity or progression.   "
76639|NCT02282787|"     During LA in retinal surgery there is some problem as regard the lack of anaesthesia duration     and unexpected globe movement .so many adjuvant was added to LA to overcome this     disadvantages of LA such as clonidine and fentanyl .      The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong     anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation     of LA.There are Many studies had described the effects of dexmedetomidine on peripheral nerve     blocks, spinal but up to date no knowledge is available on the impact of dexmedetomidine     adjuvant to local anaesthetic in ophthalmic surgery   "
76640|NCT02282774|"     To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on     postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for     vitreoretinal surgery.   "
76641|NCT02282761|"     The study will be conducted as a randomized, double-blind, parallel-group,     placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an     acute exacerbation of psychosis.   "
76642|NCT02282748|"     The planned research project is a prospective population-based cohort study, similar to the     well-known Framingham study in the United States. So far, there is no similar research     project in Switzerland.      It is planned to start with an initial cross-sectional examination of four Swiss     municipalities (Buttisholz LU, Glarus Süd GL, Lostallo GR and Cama GR) in 2014.     Cross-sectional follow-up examinations will be performed after 5 and 10 years and in 10-year     intervals thereafter.      The examinations embrace a broad spectrum of measurements (for details the investigators     refer to the study protocol).   "
76643|NCT02282735|"     Parental decision-making for children with advanced cancer is complex. Many parents have     overly optimistic beliefs about prognosis and as a result choose aggressive measures even at     the end of life, which are associated with greater suffering. Yet most parents wish to limit     suffering, and in retrospect, many regret choices for cancer treatment for advanced cancer.     These findings suggest that parents do not always have the information they need to make     decisions that reflect their preferences.      The proposed study will evaluate parental decision-making in advanced cancer, addressing gaps     in the literature in 3 important respects. 1) Previous work on decision-making for children     with advanced cancer has typically looked at decisions at one point in time, often asking     parents to reflect on decisions after the child's death, even though parents' understanding     of prognosis and decisions about care evolve over time. We will evaluate parental     decision-making for advanced cancer over time. 2) Existing work focuses on aggressive     end-of-life care as the worst possible outcome. However, some parents wish to pursue     aggressive measures even when they recognize that the child has little chance for cure. We     will evaluate the extent to which parental decision-making is informed and consonant with     preferences, regardless of whether decisions lead to aggressive or palliative care. 3)     Previous studies have focused on groups of different childhood cancers, making it difficult     to ascertain whether differences in decision-making reflect differences in diseases, options     for care, or parent preferences. We will focus on a single disease, relapsed neuroblastoma,     as a model for parental decision-making.   "
76644|NCT02282722|"     Patients are routinely asked to sign an informed consent document prior to starting     chemotherapy, indicating they understand the risks and benefits of treatment. Although this     could be a strategic moment to equip patients with information they need to make truly     informed medical decisions, many patients and caregivers note that these conversations are     less useful than they could be. The informed consent process and its associated documents     suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials     focus on individual drugs instead of regimens; 3) information is presented in written instead     of alternative written/audiovisual format; and 4) the patient perspective is lacking.      The overarching objective of this project is to develop a library of communication tools for     the most common chemotherapy regimens used to treat metastatic colorectal cancer. Tools will     include video clips and written documents that can be readily distributed, modified, and     customized. This toolkit will be crafted in collaboration with oncologists and patients     living with gastrointestinal cancer and improves upon existing resources in several ways: 1)     balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3)     use of both written and video format, and 4) inclusion of the patient perspective (e.g. video     clips of patients describing their experience). A panel of oncologist and patient     stakeholders will evaluate the acceptability of the tools. The investigators will then     conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves     the quality of informed consent for palliative chemotherapy. If effective, the tools will be     amenable to broad dissemination via patient accessible cancer education websites and oncology     clinics.   "
76645|NCT02282709|"     Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell     response, due to continuous pressure of high viral load. Treatment of chronic HCV patients     with ASV and DCV will result in a significant drop in HCV viral load. At present, no     information is available on the immunological effects of treatment with ASV and DCV, nor on     the early effects of viral load reduction caused by a compound that is thought not to possess     direct immunomodulatory effects. This information will be crucial for a better understanding     of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound     or relapses during, at the end of treatment or during the follow up period.      Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV     patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.      Study design: This is an investigator-initiated single center open label study with one arm     of 12 patients.      Study population: Adult chronic HCV patients with genotype 1b, who are previous     non-responders to the treatment.      Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and     once daily a 60 mg DCV for 24 weeks.      Main study parameters/endpoints:        1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T          cells, NK cells and monocytes        2. Gene expression levels of leukocyte populations before, during and after treatment        3. Gene expression levels of the type I IFN signaling pathway on whole blood samples        4. Serum cytokines levels using multiplex platforms   "
76660|NCT02282514|"     Non-myeloablative regimens (as the investigators use herein) are designed to maximally     suppress the immune system without destruction of the bone marrow stem cell compartment.      When using a non-myeloablative regimen recovery occurs without infusion of stem cells and the     stem cells are autologous. While not necessary for recovery, stem cell infusion may shorten     the interval of neutropenia and attendant complications. Thus in reality there is no     transplant only an autologous supportive blood product.      Based on our encouraging results of non-myeloablative hematopoietic stem cell     transplantation, for patients with multiple sclerosis and chronic inflammatory demyelinating     polyneuropathy, the investigators will investigate the role of non-myeloablative     hematopoietic stem cell transplantation for patients with SPS who require assistance to     ambulate.   "
76647|NCT02282683|"     Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year     mortality. Currently, there was no evidence-based therapy such as mechanically assisted     circulatory support available in China. The investigators found glucocorticoid treatment such     as prednisone could improve cardiac performance, potentiate renal responsiveness to diuretics     in such patients. Therefore, it could be used as bridge therapy to help ACE inhibitors or     beta blocker titration. With its help, most of the patients with stage D heart failure could     be titrated to higher dose of ACE inhibitors and beta blockers during hospitalization.     However, the efficacy of long-term, low-dose of prednisone use in such patients with limited     life expectancy remain unclear. Therefore, the investigators designed this study to observe     whether putting low-dose of prednisone on the patients with stage D heart failure for long     term could further improve their survival. All patients will receive prednisone treatment     during hospitalization and receive maximum tolerated guideline-directed medical therapy     (GDMT). After discharge from hospital, the patients will be randomized to receive long-term,     low-dose prednisone treatment or standard GDMT.   "
76649|NCT02282657|"     Pathophysiological, experimental and clinical data suggest that an 'ultraprotective     mechanical ventilation strategy may further reduce VILI and ARDS-associated morbidity and     mortality. Severe hypercapnia induced by VT reduction in this setting might be efficiently     controlled by ECCO2R devices. A proof-of-concept study conducted on a limited number of ARDS     cases indicated that ECCO2R allowing VT reduction to 3.5-5 ml/kg to achieve Pplat<25 cm H2O     may further reduce VILI.   "
76650|NCT02282644|"     The recent data suggest that cancer cells at the origin of prostate cancer metastases can be     detected in an early stage. Available techniques allow phenotypic analysis of cancer cells in     circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study on     180 patients infected by prostate cancer at all stage of disease, show that c-met marker ,     integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of     metastatic progress. In this new study the investigators will analyze antibody panel by     cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer     patients.   "
76651|NCT02282631|"     The aim of this study is to investigate whether an incentive scheme is a feasible approach to     increase walking/cycling to school.   "
76652|NCT02282618|"     Although current pharmaceutical therapies have improved the survival rate in heart failure it     remains a fatal disease and is associated with a poor 3-year survival. Increased sympathetic     activity found in patients with heart failure plays an important role in the pathogenesis and     development of the disease[Provide reference]. Excessive activation of sympathetic tone     contributes to arrhythmogenesis, increased cardiac wall tension, and platelet aggregation,     promoting a vicious cycle[What cycle? Elaborate. ] in these patients.      High thoracic epidural anesthesia (HTEA) can reversibly and regionally block the cardiac     sympathetic nervous system. The method was pioneered by Prof. Liu Fengqi in 1995, and he has     accumulated clinical experiences from thousands of cases. His anecdotal experience indicates     that the method can favorably improve intractable angina, dilated cardiomyopathy, and     advanced heart failure. Though the method has been used to treat patients at our center for     many years, there has been no prospective trial of its effects on cardiovascular function, or     its efficacy to improve clinical outcomes.      The investigators propose to investigate the immediate physiologic effect and clinical     effectiveness of HTEA in treating heart failure.   "
76653|NCT02282605|"     Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal     gel in combination with body and face washing with chlorhexidine gluconate cloths in     eradicating nasal carriage of Staphylococcus aureus.   "
76654|NCT02282592|"     The role among metabolic syndrome and breast cancer risk is not well understood and must be     further explored. The objective of this study is to evaluate the association between     metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast     cancer patients and controls without malignant disease, matched for age (±5 years) and     menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and     triglycerides test. Waist circumference and blood pressure were measured using standardized     procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006)     definitions. Cases and controls were compared in relation to the presence of diagnosed MetS     (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and     according to each metabolic abnormality cutoff point.   "
76655|NCT02282579|"     The purpose of this retrospective observational study was to analyze the effect of targeted     therapies administered as second-line treatment after failure of pazopanib as well as     increase the amount of information available on efficacy and safety of pazopanib as a     first-line therapy in practice usual for the clinical treatment of metastatic Renal     Carcinoma.   "
76656|NCT02282566|"     This study investigates whether a protein-nutrition beverage can increase muscle protein     synthesis to a similar magnitude as a control beverage.   "
76657|NCT02282553|"     This is a pilot prospective single blind controlled trial comparing magnetically steerable     gastric capsule endoscopy to conventional oesophagogastroduodenoscopy in diagnosing upper     gastrointestinal pathology in patients with recurrent/refractory iron-deficient anaemia.   "
76658|NCT02282540|"     The purpose of the study is to establish wether a contrast medium applied to the middle ear     can be used to diagnose pathology in the auditory tube. We will examine patients with and     without middle ear disease with CT after the application of an iodine based contrast medium.   "
76659|NCT02282527|"     Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study     to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI     compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin     Deficiency (AATD).   "
76661|NCT02282501|"     Enteral alimentation is the preferred modality of support in critical patients who have     acceptable digestive function and are unable to eat orally, but the advantages of continuous     versus intermittent administration are surrounded by controversy.      This prospective, randomised study was designed to compare two enteral feeding methods with     respect to changes in levels of leptin and ghrelin in ICU.   "
76665|NCT02282449|"     Patients with cancer often require intravenous chemotherapy for long periods of time.      Ensuring that these patients have safe and reliable access to the veins for chemotherapy is     challenging, and sometimes a medical device is required to administer the chemotherapy into     the veins.      A totally implanted venous access device, or port, is implanted under the skin of the arm and     is attached to a small plastic catheter that enters into the veins. This device can be     punctured with a needle when needed for treatment or testing.      Some types of these vein ports can rapidly inject fluids (power injection), and can be used     for follow-up imaging studies, such as computed tomography, that are required to follow     cancer treatment effectiveness. There are no publications of randomized patients discussing     the impact of power injection upon TIVAD complications and device longevity for arm     implantation. The investigators propose to compare the effectiveness of power injectable     against non-power injectable ports to determine if they have different clinical performance     and complications. Our results will impact the care provided to cancer patients.   "
76953|NCT02278575|"     The study will be an open controlled pilot study of 6 patients with early-onset severe     preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients     will be followed up within the study until three days after delivery. Laboratory analyses and     uterine and umbiliacal blood flow will be determined.   "
76666|NCT02282436|"     Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality     worldwide. Its prevalence is in progression and COPD is expected to become the fourth leading     cause of death by 2030. COPD is characterized by periods of stability interspersed with acute     infectious/inflammatory flare-ups, also called acute exacerbations, during which patients     deteriorate, sometimes to the point of requiring immediate medical assistance. Although most     patients eventually recover, repeated episodes of exacerbations may accelerate COPD     progression. Exacerbations may further compromise the integrity of limb muscles by promoting     further loss in muscle mass and strength.      The overall objective of this substudy is to elucidate how an acute COPD exacerbation may     affect limb muscles.   "
76667|NCT02282423|"     The goal of this study is to understand how and why insulin resistant individuals respond     differently to exercise as compared with insulin sensitive individuals at the skeletal muscle     and gene expression level.   "
76668|NCT02282410|"     Based on the successful pioneer work of Dr Nilsson and her colleagues in Sweden that started     in the late 1950's, prophylaxis is recommend as the standard of care for boys with severe     haemophilia by WHO and World Federation of Hemophilia (WFH). The efficacy and safety of     prophylaxis in preventing bleeds and arthropathy in patients with hemophilia has been     confirmed in well-designed clinical studies.To keep the factor level above 1%, the standard     dosage for patients with severe hemophilia A is 20-40 Units /kg/infusion (average 30 Units     /kg) every other day or three times a week. This dosage has a very high consumption of     factor, up to 5000-6000 international unit(IU)/kg/year. The high consumption of factor and     cost present a major barrier to use the standard prophylaxis in many countries particularly     in the developing world.      But after the Recombinant Human Coagulation Factor VIII for injection (ADVATE) Patient     Assistance Program(Golden Key) was launched in 24 Apr 2014 in Nanjing China, the     affordability of patients was solved and many patients will get more chance to receive     standard prophylaxis.      This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and     QoL outcomes in subjects using standard prophylaxis under the conditions of routine practice.   "
76669|NCT02282397|"     Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves     glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood     glucose (SMBG) testing, who are not at target glycemic control.   "
76670|NCT02282384|"     The proposed pilot study will provide needed data to establish the feasibility of a     conducting a large randomized controlled trial as to the effectiveness of the use of     oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.   "
76671|NCT02282371|"     This is a phase 1b study, which means that the purpose of the study is to establish the     maximum dose of a pill drug called BYL719, when given with a standard treatment for patients     with head and neck squamous cell cancer.   "
76672|NCT02282358|"     The purpose of this study is to learn if the study drug mocetinostat can slow the progression     of cancer in people who have a mutation in CREBBP or EP300 in the genetic makeup of their     cancer. The potential side effects of mocetinostat will also be studied.   "
76673|NCT02282345|"     The goal of this clinical research study is to learn if talazoparib can help to control     breast cancer that has a BRCA mutation (genetic change). The safety of talazoparib will also     be studied.   "
76674|NCT02282332|"     The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by     Near-Infrared Spectroscopy study will evaluate whether ticagrelor leads to a 20% reduction in     the LCBI with NIRS/IVUS suggesting coronary plaque stabilization and reduced inflammation in     patients already on long-term statin therapy undergoing non-urgent PCI. It is hypothesized     that the treatment with ticagrelor following PCI will lead to a significant 20% reduction in     the lipid pool as measured by NIRS/IVUS at follow-up when compared with baseline imaging,     suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic     lesions not treated during the index procedure.   "
76675|NCT02282319|"     The primary objective of this double blind randomized study is to determine the effect of     dexmedetomidine on onset and duration of the sensory and motor block and on the influence on     bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that     sensory block will significantly be prolonged by dexmedetomidine administered by both the     spinal and the intravenous route. The investigators do not expect a significant difference in     motor block duration between intravenous or spinal administration. Secondary outcomes are     micturition problems, duration of analgesia and the occurrence of side effects such as     sedation and hypotension.   "
76676|NCT02282306|"     There has been a dramatic rise in opioid overdose (OOD) deaths in recent years. Attempts to     ameliorate the problem have largely focused on increasing the accessibility of naloxone, an     opioid antagonist that is effective in OOD reversal. Individuals who have experienced a     non-fatal OOD are at risk for additional overdoses and yet there are no interventions that     specifically target this high-risk population. To address this gap, the investigators have     developed the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid     Overdoses (TTIP-PRO). The overall goal of the present study is to conduct a pilot evaluation     of the TTIP-PRO. The research literature suggests the need for an intervention targeting     patients experiencing a non-fatal OOD.   "
77167|NCT02275793|"     Peripheral blood and blood following a pulmonary wedge pressure will be obtained from     patients undergoing right heart catheterizations.   "
76692|NCT02281994|"     The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing,     compared with standard conservative care, in subjects 50 years of age and over diagnosed with     Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects     will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan.     Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo     control) to either the active or control device for 4 hours a day for 6 months. X-rays will     be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process,     with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at     6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will     be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either     an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim     Model 2205OD device.   "
76677|NCT02282293|"     This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women     living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women     between 12 and 28 weeks gestation will be randomized to receive enhanced malaria     chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo.     Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of     age to which the mothers were randomized. All women will receive daily     trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health     guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be     considered a study drug only in infants and children beginning 6 weeks after cessation of     breastfeeding and upon exclusion of HIV infection. Women and their children will be followed     for 36 months after delivery. In a subset of the study population, the investigators will     conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP     and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in     the study. The investigators will test the hypothesis that for HIV-infected mothers and     HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected     pregnant women and their children will reduce the incidence of malaria among children from 0     to 24 months of age and improve the development of naturally acquired antimalarial immunity.   "
76678|NCT02282280|"     Observation of the effects of an administration of prilocaine chlorhydrate hyperbare in     rachianesthesia among a general surgical population.   "
76679|NCT02282267|"     This study was proposed to validate the efficacy of gefitinib as first-line therapy in     advanced lung adenocarcinoma with EGFR mutation determined by plasma cf-DNA.   "
76680|NCT02282254|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would     regulate glucose levels through the infusion of two hormones: insulin and glucagon.      The main objective of this project is to compare the efficacy of single-hormone and     dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study     in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal     hypoglycemia.      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in     regulating overnight glucose levels compared to single-hormone closed-loop strategy.   "
76681|NCT02282241|"     Delirium is a common complication of illness especially among the elderly with serious     sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric     emergency has key features including acute onset, fluctuating level of consciousness, poor     attention and cognitive deficits with a presentation which may include hallucinations and     delusions.      A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin is     a widely available natural health product with evidence in normalizing circadian rhythms and     sleep. There is also preliminary evidence that melatonin can be used to prevent the     development of delirium in hospitalized patients. We hypothesize that daily administration of     melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for     14 days, will lead to decreased rates of delirium compared to placebo-treated comparison     subjects.   "
76682|NCT02282228|"     An open study evaluating the sensitivity and specificity of a microwave-based device,     Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements     on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched     group of healthy volunteers.   "
76683|NCT02282215|"     The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra     supportive care measure after induction chemotherapy for patients with acute myeloid leukemia     (AML).   "
76684|NCT02282202|"     The purpose of this study is to evaluate the safety and efficacy of four times daily Positive     Expiratory Pressure (oPEP) (Aerobika ®) maneuvers over three weeks in individuals with     bronchiectasis and chronic obstructive pulmonary disease (COPD) with chronic sputum     production. The investigators hypothesize that four times daily positive expiratory pressure     using the Aerobika ® will significantly improve dyspnea, movement of mucus, St. George's     Respiratory Questionnaire (SGRQ) score, and six-minute walk distance (6MWD) after three weeks     of four times daily administration.   "
76685|NCT02282189|"     The purpose of this study is to evaluate the safety and efficacy of four times daily     oscillatory Positive Expiratory Pressure (oPEP) (Aerobika ®) use over 4 weeks in individuals     with stable chronic obstructive pulmonary disease (COPD). The investigators hypothesize that     daily oPEP use will significantly improve St. George's Respiratory Questionnaire (SGRQ)     score, six-minute walk distance (6MWD) and forced expiratory volume in one second (FEV1)     after four weeks of four times daily administration.   "
76686|NCT02282176|"     The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of     bronchopulmonary dysplasia in preterm neonates.   "
76687|NCT02282163|"     Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV     EBD on non-contrast 2D echocardiography. Imaging conditions will represent those in routine     clinical practice and will include LV EBD with harmonic imaging modality.   "
76688|NCT02282150|"     Despite optimized hydrocortisone replacement regimes, many patients with adrenal     insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients     report high fatigue levels at certain times during the day. A modified-release hydrocortisone     has been shown to improve QoL, particularly fatigue, in patients with primary AI. However, it     is unknown, if the same effect can be observed in patients with secondary AI. Further, no     studies have evaluated the effect, taking into account the diurnal variation of fatigue. A     novel survey method termed Ecological Momentary Assessments (EMA) has the potential to     provide reliable measurements of diurnal variations in patient-reported outcomes, such as     fatigue. We will compare the effect of modified-release compared to conventional     hydrocortisone on fatigue in patients with secondary AI due to pituitary disease, and hereby     assess the feasibility of EMA as outcome in future large-scale randomised clinical trials     (RCTs).   "
76689|NCT02282137|"     Single center, Prospective, Phase II expanded access clinical studies of 68Ga-PSMA     (ProstaMedix TM) used for diagnosis and management of patients with prostate cancer.   "
76693|NCT02281981|"     Arterial Stiffness: As a recognized independent indicator of cardiovascular risk, maintaining     low levels of arterial stiffening is important to cardiovascular health. Increases in     arterial stiffening results in elevated systolic and mean pressure and it is correlated with     various cardiovascular conditions such as left ventricular hypertrophy, ischaemic heart     disease, and myocardial infarction. In contrast, decreased arterial stiffness improves     ventricular-vascular coupling, ejection fraction, and cardiac output. Arterial stiffness is     linked to inflammation and oxidative stress. Both inflammation and oxidative stress are     elevated during DOMS (delayed onset muscle soreness), a state brought on by muscle damage     often incurred during strenuous exercise. Recent studies have shown that a single bout of     eccentric exercise can produce acute arterial stiffness during recovery. However,     anti-oxidants/anti-inflammatories may be effective in reducing the extent of damage by     decreasing oxidation and inflammation. Curcumin is a powerful antioxidant that could act as     an anti-inflammatory and diminish the effects of the downhill run. In addition, eccentric     damage generates a prophylactic protection lasting up to six weeks. The nature of the     downhill run is primarily eccentric in nature. Therefore, repeated bouts may have diminished     DOMS development. Any reduction in stress by either the prophylactic repeated bout effect or     the Curcumin supplement, should attenuate the increase in arterial stiffness due to the     reduction in inflammation.   "
76694|NCT02281968|"     The purpose of this study is to investigate if it is possible to decrease opioid consumption     in patients undergoing ankle fracture surgery by providing scheduled doses of nonsteroidal     inflammatory drugs (NSAIDs). This is a prospective, randomized, double-blinded, placebo     controlled study with two groups of patients: one getting NSAIDs to take at regularly     scheduled times plus a traditional prescription for opioid medication and one receiving the     traditional prescription for opioid medication and a placebo. Patients will be assigned to a     group from a computer-generated program. Neither the patients nor their doctors or nurses     will know what group they are in, only the pharmacist will have that information. Patients in     both groups will have the opportunity to take opioid medications if the pain becomes     unmanageable.   "
76695|NCT02281955|"     The purpose of this research study is to learn about the effectiveness of using     lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated     low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck.     The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment     for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is     performed afterwards. This standard regimen causes a lot of side effects and long term     complications. This study is evaluating whether a lower dose of radiation and chemotherapy     may provide a similar cure rate as the longer, more intensive standard regimen. Patients in     this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy.   "
76696|NCT02281942|"     Low self-control has been associated with a number of unhealthy behaviors with low treatment     success. Alternative non-pharmacological approaches have the potential for enhancing     self-control. This pilot study will investigate if the practice of yoga and/or health and     wellness education improve self-control in the context of nicotine addiction, and will set     the stage for larger clinical trials using behavioral interventions to supplement or replace     existing treatments and increase the rates of recovery from disorders in which low     self-control is a susceptibility factor.   "
76697|NCT02281929|"     Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for     28 days. However, about 25-35% of patients do not take benefit from this treatment and die     within the 6 months following the diagnosis. Numerous trials have evaluated the impact of     several strategies in association with corticosteroids. None of them has shown an improvement     in survival (primary endpoint) as compared to corticosteroids alone.      The project is based on an approach never tested in a randomized controlled trial in severe     alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2     months). This approach is based on animal and human studies.Antibiotics are effective in     animal models and in other circumstances characterized by liver failure such as     gastrointestinal bleeding related to portal hypertension. The interest of studying this     population is emphasized by the frequency of infections in these critically ill patients.     Antibiotics will be administered before the development of any infection, as it is likely     that these patients present with mesenteric bacterial adenitis without systemic signs of     infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and     treatment is given for 30 days.   "
76698|NCT02281916|"     This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd     glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD),     before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from     Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental     evidence of its anti-inflammatory properties, the investigators hypothesized that     administration of P28GST could protect against recurrence after intestinal resection surgery     in CD.   "
76699|NCT02281903|"     The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard     basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation.     Therefore, our hypothesis was that there would be no difference between both CPR methods in     terms of chest compression quality parameters.   "
81210|NCT02222961|"     The objective of the present study is to obtain information about the safety, tolerability     and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing     doses in healthy young volunteers   "
76700|NCT02281890|"     Neonatal sepsis is an important determinant of adverse neurodevelopmental outcome. The     investigators seek to investigate whether neurodevelopmental outcome following neonatal     sepsis differs according to whether or not the diagnosis is confirmed by culture. In a     secondary analysis of all 3493 infants included in the International Neonatal Immunotherapy     Study (INIS) randomized controlled trial of intravenous immunoglobulin for neonatal sepsis,     the investigators will evaluate neurodevelopmental outcomes according to whether or not the     sepsis was culture-proven. The primary outcome is death or major disability at two years. In     secondary analyses the investigators will determine neurodevelopmental outcomes according to     the causative organism identified. Greater understanding of the impact of culture-positivity     on long-term outcomes in the setting of clinical neonatal sepsis is essential to better     inform parents about the future prospects of their child and to guide patient follow-up.   "
76701|NCT02281877|"     The overall goals of this work are: 1) to elucidate alterations in gene expression and     downstream protein synthesis 2 weeks after Total Knee Arthroplasty (TKA) to better explain     quadriceps muscle atrophy after TKA and 2) understand the mechanisms responsible for improved     maintenance of muscle strength with Neuromuscular Electrical Stimulation (NMES) utilization.     Furthermore, this investigation seeks to expand previous findings regarding attenuation of     strength and functional performance deficits with NMES application to better understand how     altered gene expression influences muscle function.   "
76702|NCT02281864|"     Children who are hospitalized are especially vulnerable to the effects of tobacco use and     dependence among their caregivers, and they are more likely to be exposed than children who     are not hospitalized. Hospitalization is an important teachable moment for health care     providers to intervene with tobacco dependent parents, and help them reduce their child's     exposure, potentially improving outcomes after hospitalization, and their future health.     Understanding the best way to approach and intervene with these families will provide the     investigator with the necessary information to create a sustainable intervention that can be     disseminated to hospitals across the country that provide pediatric care, and to ultimately     make a significant improvement in the health of children.   "
76703|NCT02281851|"     This study will investigate whether increased habitual intake of antioxidant supplements     effects the concentration of endogenous antioxidants, the response of antioxidants to     exercise, and differences in oxidative damage compared to a non-supplemented group.   "
76704|NCT02281838|"     The vast majority of intracerebral hemorrhage (ICH) patients present with elevated blood     pressure(BP). Management of BP is controversial with two competing rationales. There is some     evidence that hyperacute treatment may improve outcomes by reducing the rate of hematoma     expansion. Physicians have been reluctant to reduce BP early after ICH onset, fearing reduced     cerebral blood flow (CBF) will increase ischemia and increase the risk of further damage.     Other confounding mediators to further ischemic injury following ICH include increased     platelet activity, withdrawal of antithrombotic therapy, endothelial dysfunction,     inflammation and hypercoagulability.      This study is phase II of the ICH-ADAPT study. The investigators hypothesize that aggressive     antihypertensive therapy will alter the natural history of heamatoma growth, improving     outcomes after Intracranial Hemorrhage (ICH). The previous phase I ICH-ADAPT study has     established the safety of early BP treatment.      The investigators have designed a phase II study in which ICH patients are randomized to     aggressive versus conservative BP treatment using a deferred consent procedure. An adaptive     randomization will be used to treat BP to < 140 mmHg SBP or < 180 mmHg SBP. Treatment must be     implemented as soon as possible after radiological confirmation of diagnosis.     Antihypertensive therapy must begin within 6 hours of symptom onset. The patient will be     re-imaged 24 hours later. The patient will have continuous non-invasive BP and heart rate(HR)     monitoring for a minimum of 24 hours. Antihypertensive drug use and dosage will be recorded     with BP and HR. Patients will be monitored regularly until study completion. MRI's will be     done at 48 hours, day 7 and day 30. This imaging will help to detect ischemic changes that     may occur. Blood will be collected at the same time as the MRI. Blood analysis will be done     to possibly identify biomarkers that may be putative mediators of ischemic injury in ICH     patients.   "
76705|NCT02281825|"     The present study will explore a new approach to ongoing evaluation and monitoring of     fluctuations in personality traits via commercial video games. The aim of this longitudinal     study is to examine the influence of everyday life event on video games performance as a     function of individual differences in gaming behavioral patterns. focusing on the ongoing     performance vacillations of the patient on commercial video games will offer insights in to     possibly new generation of real time assessment medium of ongoing behavior.   "
76706|NCT02281812|"     Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure     widespread accepted in the treatment of different tumors, especially in the liver but its     benefit is not yet well-known in breast cancer.      Our main objective is to evaluate the usefulness of RFA in < 2cm malignant breast tumors to     reduce the proportion of positive margins.      Methodology: The investigator propose a single-center, single-blind, phase I and II     randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the     potential adverse effects in three stages: initial,intermediate and final. Phase II:     Randomized clinical trial, 2 parallel groups with 37 patients in each one.      Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group:     conventional surgery with lumpectomy. The number of positive margins in both groups, and the     need of extending margin resection will be assessed intraoperatively. Inclusion criteria:     women >40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique,     visible by ultrasound, smaller than 2cm and located > 1 cm from the chest wall and the skin.     Patients will be followed up for a period of two years to assess cosmetic result, short -term     and long -term complications and recurrences.      Expected results: The cool-tip (cluster) ablation method reduces by at least 30% the risk     of intraoperative extensions for positive margins during lumpectomy compared to conventional     surgery in breast tumors with a diameter < 2 cm.      Therefore this procedure may reduce the risk of second surgeries and the removed volume of     tissue.Consequently the final cosmetic result should be improved.   "
76717|NCT02281656|"     Ulnar nerve compression at the elbow is a common problem and can significantly affect hand     function in severe cases. The current, standard treatment is Ulnar nerve decompression with     or without transposition (moving the ulnar nerve to a site where there is less compression).     In severe compression, the clinical results after this surgery are typically poor. Distal     transfers of functioning nerves (at the level of the wrist) to the compressed ulnar nerve     (anterior interosseous nerve to ulnar motor fascicles) have been suggested to supercharge     or augment hand muscles while nerve axons regenerate from the level of the elbow after     decompression/transposition. In fact, this treatment is becoming widely adopted without clear     evidence that it changes outcomes. The investigators propose to prospectively compare the     effectiveness of ulnar nerve decompression/transposition versus decompression/transposition     and distal nerve transfer.   "
76718|NCT02281643|"     This study will determine the influence of doxycycline treatment against Wolbachia/M.     perstans on immunity against concomitant mycobacterial infections in healthy M. perstans     infected individuals. In this regard, the investigators will perform a community-based     randomized controlled trial (Phase 2a) in Asante Akim North District. A cohort of 200     participants who are contacts of patients with Tuberculosis or Buruli ulcer, of both sexes     with no clinical condition requiring long-term medication but connected with Mansonella     perstans will be investigated for the effect of doxycycline on microfilaria, the immune     response and development of mycobacterial disease.   "
76719|NCT02281630|"     The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to     determine its optimal dose in Chronic Constipation (CC) patients.   "
76707|NCT02281799|"     Azathioprine (AZA) and its metabolite 6-mercaptopurine (6-MP) were developed over 50 years     ago by Gertrude Elion and George Hitchings and were initially used clinically in the     management of childhood leukemia and organ transplantation.      The first case report of 6-MP use in inflammatory bowel disease (IBD) was from 1962 , and     since then the use of thiopurines has been well established in the management of moderate to     severe IBD.      Thiopurines offer an inexpensive and effective treatment option for maintenance of remission     of IBD in comparison to biological agents which may be 30 times more expensive .      Although 50-60% of IBD patients respond to thiopurines, a significant proportion of patients     will not tolerate them due to various adverse effects . The adverse effects of thiopurines     may be dose related, patient related or idiosyncratic.      The immunosuppressive effects of thiopurines also increase the rates of opportunistic     infections.      Thiopurines are also associated with a higher rate of malignancies, particularly a malignant     Burkitt-like lymphoma, related to Epstein-Barr virus infection . Other adverse effects of     thiopurine relate to allergic phenomenon.      An idiosyncratic adverse effect of thiopurine use is acute pancreatitis (AP).      Acute inflammation of the pancreas defined by INSPPIRE criteria:      requiring 2 of:        1. Abdominal pain compatible with AP        2. Serum amylase and/or lipase ≥ 3 times upper limits of normal        3. Imaging findings of AP      Drug induced AP is the assumed diagnosis when no other cause of AP can be found, the patient     is taking a drug known to be associated with AP, and symptoms resolve after drug     discontinuation. If pancreatitis re-occurs on re-exposure, the drug is definitely considered     the cause.      While drugs are considered a rare cause of AP and most cases are mild and self limited ,     there is an 8 fold higher risk of AP in IBD patients treated with AZA . Thiopurine induced AP     is usually detected within 4 weeks of starting treatment.      However in the case of thiopurine induced AP, there has been no clear understanding of the     mechanism.      Thiopurine induced AP is generally considered an indication to cease thiopurine therapy, due     to the assumed risk of recurrence of AP on reintroduction.      There exists several case reports and anecdotal evidence that reintroducing thiopurines     following an assumed thiopurine associated AP can be well tolerated.      The investigators hypothesize that AZA and/or 6-MP can be safely reintroduced in the     management of IBD patients following thiopurine-induced pancreatitis.      If in the past the patients were treated with AZA, they will now be commenced on 6-MP, and if     in the past they were treated with 6-MP, they will be commenced on AZA.   "
76708|NCT02281786|"     This is a single center, randomized, investigator/subject blind, single ascending dose,     placebo-controlled, parallel study that will evaluate the safety, tolerability and     pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive     in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration     of the study is 16 weeks.   "
76709|NCT02281773|"     The objective of the study is to investigate the efficacy, safety and tolerability of four     different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients     with schizophrenia on stable antipsychotic treatment.   "
76710|NCT02281760|"     Erdheim-Chester Diseases (ECD) is a very rare non-Langerhans cell histiocytosis of unknown     origin and pathogenesis. It has been reported mainly in adult males over the age of 40 years,     although cases have been reported in females as well. Children are rarely affected. Mutation     of the BRAF gene, specifically BRAFV600E, has been recently identified in 50% of Erdheim     Chester lesions in a French cohort. This somatic mutation is believed to be the driver     mutation in positive cases. The clinical characteristics of ECD range from asymptomatic to     multisystemic involvement; longitudinal progression and natural history are becoming better     understood. ECD commonly affects the bones, kidneys, retroperitoneal space, skin and brain.     If untreated, the disease progresses rapidly, causing fatal outcomes due to severe lung     disease, chronic renal failure, cardiomyopathy and other complications. The diagnosis of ECD     relies upon imaging studies and specific pathologic findings in biopsies of affected organs,     i.e., fibrosis and infiltration of tissues with foamy histiocytes, lymphocytes, and plasma     cells. Immunohistochemistry reveals cells positive for CD68 and CD163 and negative for CD1a,     with 20% positivity to S-100. There is no standard treatment for ECD, although chemotherapy,     radiation, stem cell transplantion, alpha-interferon, anakinra, imatinib and sirolimus have     been proposed. The recent discovery of the BRAFV600E mutation in several ECD patients has     opened a new area for treatment options. Vemurafenib, an FDA approved BRAF inhibitor for the     treatment of patients with metastatic or unresectable melanoma with the V600E mutation, binds     to this form of mutated BRAF causing protein inactivation. The use of vemurafenib in patients     with ECD has been reported in 3 patients who experienced remission of the disease, and is     currently being studied in the U.S. and Europe as monotherapy. Tumor/disease resistance to     vemurafenib has occurred in melanoma and other cancers, although it has not been reported in     patients with ECD. In this protocol, we propose to clinically evaluate ECD patients with the     BRAFV600E mutation and administer combination therapy with dabrafenib, a BRAFV600E inhibitor,     and trametinib, an inhibitor of MEK, downstream of BRAF. Screening for possible     contraindications will be made prior to the administration of the first dose. With this     trial, we will determine the safety, tolerability, and efficacy of dabrafenib and trametinib     in patients with ECD who harbor the BRAFV600E mutation. Dabrafenib 150mg will be given twice     daily p.o.; trametinib 2mg will be given once daily p.o. Patients will be seen 1 week, 1     month, 2 months, 4 months, and 6 months, 8 months, 10 months and 12 months to complete a     oneyear trial.   "
76711|NCT02281747|"     Background:      - Orthopedic procedures are common in the United States. These include joint replacement and     spine surgeries. Researchers want to study data about these procedures over time. They want     to see if treatment has gotten better. They also want to find ways to change the care that     people get before and after they have these procedures. These changes may lower the risk of     problems people can have during and after treatment. They may also improve people s results.      Objectives:      - To study a series of questions about surgery, medicine, treatments, and outcomes for     orthopedic procedures.      Eligibility:      - Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2012.      Design:        -  Researchers will look at data for people ages 20 100.        -  No new participants will be used in this study.        -  The study will last 4 years.   "
76712|NCT02281721|"     The purpose of this observational post-marketing registry will be to collect and analyze     safety, effectiveness, and quality of life outcomes, during and after treatment with the     Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and     analyzed.   "
76713|NCT02281708|"     Researchers developed the nomogram which evaluate the risk of recurrence after surgical     resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram     showed similar recurrence rate to the recurrence rate of stage 2 NSCLC patients. Thus those     stage 1 NSCLC patients at high recurrence rate are considered to show positive effect of     adjuvant chemotherapy and perform the study to prove this hypothesis.      Applying the nomogram, the patient scored lower than 104 is categorized into low risk group     and is to be grouped as the observation group which adjuvant chemotherapy will not be given.     The high risk group patients (the nomogram scored larger than 104) are randomly divided into     the treatment group and the observation group. Then, the clinical result on the recurrence     between the observation group and the treatment group will be compared.      - Regimen of the adjuvant chemotherapy: The most commonly used 1st line chemotherapy regimen     which is vinorelbine plus cisplatin will be admitted for 4 cycles. Also the three days before     and the after the estimated day are permitted as allowance.      Intravenous administration of vinorelbine (25mg/m2), the 1st and the 8th day of the each     cycle, every 3 weeks.      Intravenous administration of cisplatin (75mg/m2), the 1st day of the each cycle, every 3     weeks.   "
76714|NCT02281695|"     The purpose of this study is to determine the differences in oxygenation and decarboxylation     between two weaning processes.   "
76715|NCT02281682|"     A multi-centre randomised controled single blind clinical phase IV trial with the aim to     determine the most effective treatment in terms of lesion reduction, costs and patient     satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with     photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and     ingenol mebutate (IM) gel.   "
76720|NCT02281617|"     Patients experience problems with their memories from a variety of causes. There has been     much work showing that the use of low tech devices, such as notebooks or diaries, can help     patients remain independent. More recently, the use of electronic devices, such as digital     voice recorders or pagers, has proved equally beneficial. Many of functions of memory aids     could potentially be carried out by a smartphone or tablet using inbuilt functions such as a     calendar or maps, as well as through downloadable apps, such as medication reminders. The     investigators have surveyed the investigators patients to show that many of them already own     smartphones and this number has dramatically increased in the last year. This project aims to     investigate the feasibility and efficacy of using smartphone and tablet apps as memory aids     in a clinical setting.   "
76721|NCT02281604|"     The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line     filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.   "
76722|NCT02281591|"     Single centre, open-label, randomised study in four parallel groups of healthy volunteers   "
76723|NCT02281578|"     The Phase II trial will assess the feasibility, acceptance, safety, pathways, and initial     effectiveness of a community-based combination HIV prevention intervention among bar-based     female sex workers in Iringa, Tanzania. Results will inform an appropriately powered Phase     III RCT as warranted.   "
76724|NCT02281565|"     The study evaluates the knowledge, attitude and practice about blood donation among medical     students and medical staff in Poland.   "
76725|NCT02281552|"     This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib     modified release tablet taken once a day in patients with rheumatoid arthritis who continue     taking methotrexate. Results for the modified release tablets will be compared to the     efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in     patients with rheumatoid arthritis who continue taking methotrexate.   "
76726|NCT02281539|"     The goal of the clinical investigation is to reduce phantom limb pain (PLP), painful     condition affecting 70% of amputees, so as to improve these patients' quality of life.   "
76727|NCT02281526|"     Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with     moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a     treatment phase and a follow-up visit. All subjects were to be treated with study medication     for 8 consecutive days. Blood and urine were collected for the PK analysis, and safety     assessments were performed.   "
76728|NCT02281513|"     Participants from the Fatigue and Lifestyle Physical Activity and SLE Study will be     approached to enroll in a 6 week pilot intervention. This study will look at the barriers and     facilitators to increasing physical activity, improving dietary/nutritional intake, and     improving sleep.This study will offer support and information for people with SLE to increase     their physical activity, improve their dietary/nutritional intake, and improve their sleep     and will utilize a smartphone application to self-monitor changes in these behaviors.   "
76729|NCT02281500|"     Multicenter, Prospective, Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics,     Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients with     Congenital Afibrinogenaemia   "
76730|NCT02281487|"     The purpose of this study is to determine whether a tubectomy during hysterectomy for benign     gynaecological conditions does not result into a premature menopause.   "
76731|NCT02281474|"     This pilot study will test Nilotinib's ability to alter the abnormal protein build up in     Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib     at different doses for 6 months. Patients will then be tested to see if there is change in     three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded     protein changed in the fluid around their brain and spine. 3) Have inflammatory markers     changed in the patient's blood and fluid around their brain and spine. If successful, this     drug could be used to slow down or stop the progression of disorders that involve abnormal     collection of misfolded proteins. However, the main purpose of this pilot study is to check     for the safety of using this medication at this level.   "
76732|NCT02281461|"     The PrePex is a WHO prequalified medical device for adult male circumcision for HIV     prevention. The Government of Rwanda was the first country to implement the PrePex and acts     as the leading Center of Excellence providing training and formal guidelines.      In support of efforts to scale up male circumcision, readily available data have been applied     to estimate the potential cost and impact of scaling up medical MC services in Rwanda to     reach 80 percent of adult, children and newborn males by 2015. Infant and children male     circumcision ensures that the wound will be healed before sexual activity begins, and thus     reduces the risk of HIV transmission during healing period.   "
76733|NCT02281448|"     Single centre, two-way crossover, randomised, open-label study in 20 healthy female     volunteers.The volunteers received an oral single-dose of a combined contraceptive containing     with an oral once daily dose of 1200 mg of BIA 2-093   "
76748|NCT02281253|"     The aim of this study was to evaluate the efficacy of a bakery product enriched with dietary     fibre and L-carnitine on glucose homeostasis and insulin sensitivity in overweight patients     with or without metabolic syndrome.   "
76749|NCT02281240|"     Hemostatic disorders are common and potentially fatal complications in patients undergoing     hematopoietic stem-cell transplantation (HSCT). Limited data exist on early diagnosis and     prevention of these complications. The investigators undertook this prospective study to     determine the incidence, predictor factors, specific pathogenesis, management and survival     specially for patients with thrombotic and bleeding complication to better improve outcomes.   "
76751|NCT02281214|"     The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the     primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted     treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer     remission in some patients, but use of the EGFR-TKIs is limited to patients with     adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has     become an increasingly important cause of treatment failure. Therefore, identification of the     molecular components involved could lead to the development of effective therapy. Today only     a limited number of genetic alterations are studied.      Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical     and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation     detection.   "
76734|NCT02281435|"     It is well known from a range of observational and epidemiological studies that the lifetime     risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60%     and by up to 73% in post-trial observation. Numerous papers on the topic have been published     over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan     countries.      Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011,     suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80%     coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions     between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up     would result in averting 3.36 million new HIV infections through 2025. In addition, while the     model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it     would result in net savings (due to averted treatment and care costs) amounting to US$16.51     billion.      To date, there are over 38 million adolescent and adult males in Africa that could benefit     from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely     scale up a surgical procedure in resource limited settings.   "
76735|NCT02281422|"     Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of     subjects with various degrees of renal function based on creatinine clearance   "
76736|NCT02281409|"     The purpose of this study is to find out what effects, good and/or bad, KW-0761, an     investigational drug, has on the patient and their cancer.   "
76737|NCT02281396|"     The purpose of this study is to evaluate the safety of Freeze-dried Rabies Vaccine （MRC-5     Cell) in healthy humans aged from 10-60 years old, according to the traditional Essen methods     (1-1-1-1-1) vaccination.   "
76738|NCT02281383|"     This is a phase II study. This means that BCG therapy has already been found to be safe in     humans. The investigators just want to see if using more treatments works better.   "
76739|NCT02281370|"     A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to     support the use of these drugs together in subjects, such as those with severe aplastic     anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate     the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I,     open-label, randomized, three-period cross-over study in healthy adult subjects. The study     consists of a screening visit and three treatment periods. All subjects will be randomized to     receive one of the three treatments in each treatment period separated by washout periods of     3-10 days. The total duration of a subject's participation in the study from screening to     final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment     periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at     least 10 subjects per sequence (total 30).   "
76740|NCT02281357|"     A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to     Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent     Asthma.   "
76741|NCT02281344|"     A single-centre, open-label, study using induced blood stage malaria infection to     characterize the activity of MMV390048 against early Plasmodium falciparum blood stage     infection.   "
76742|NCT02281331|"     As we age we tend to lose muscle mass and strength. These losses contribute to the increased     incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of     independence and reduced quality of life in the elderly. As the number of seniors increases     worldwide, it is becoming more and more important to develop strategies to counteract this     loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple     lifestyle modifications are the most potent defense strategies. Exercises such as weight     lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts     of vigorous aerobic exercise interspersed with period of rest, are the most effective in     promoting gains in muscle mass and strength. Additionally, components of foods like whey (a     protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to     independently increase strength. In this study, we are looking to determine how much we can     increase muscle strength in older men who are put on an 12 week exercise training program     that combines weight lifting and HIIT, and who consume a daily supplement that contains whey     protein, creatine, calcium and vitamin D.   "
76743|NCT02281318|"     This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate     the efficacy and safety of mepolizumab adjunctive therapy in participants with severe     eosinophilic asthma on markers of asthma control. The overall intent of the current study is     to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL)     and other measures of asthma control, including lung function.      Participants who meet the predefined criteria will be randomised to receive either     mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780     participants with severe eosinophilic asthma will be screened to ensure the randomisation of     544 participants (272 participants per treatment group) into the study.   "
76744|NCT02281305|"     Restoring the patency of the coronary vessels and providing the ischemic myocardium with     reperfused blood can cause additional tissue damage. A key element of ischemia and     reperfusion (I/R) injury and major determinant of the evolution of damage in the affected     myocardium is the inflammatory response. The main objective of the study is to evaluate the     efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory     response in the reperfused myocardium.   "
76745|NCT02281292|"     The purpose of this study is to evaluate the initial safety of intravitreal (IVT) LKA651 and     potential for use alone or in combination with Ranibizumab ophthalmic solution (Lucentis®)     for the treatment of Diabetic Macular Edema (DME) in patients with symptomatic disease.   "
76746|NCT02281279|"     This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide     when combined with rituximab and to see how well this combination works in treating patients     with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to     treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in     different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of     cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with     romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.   "
76747|NCT02281266|"     Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative     resection.   "
76754|NCT02281175|"     Benzodiazepines (BZD) are widely used to treat anxiety, insomnia, and depression. These drugs     can have very serious side effects if they are taken over a long period of time. In addition     to stability, memory, concentration, vigilance, and attention impairments, long-term use of     BZD is also associated with an increased in hypertension incidence, urinary incontinence,     coronary artery disease, and renal complications. There are growing evidences that long-term     BZD use causes physical and psychological dependence as evidenced by the withdrawal syndrome.      The recommended strategy by physicians to facilitate the withdrawal of BZD is to gradually     reduce the medication, either by replacing the BZD by another with a longer half-life, or by     the gradual dose reduction. Unfortunately, the success of such a procedure is low as up to     80% of people who try to quit, relapse due to the intolerance of withdrawal symptoms.     Therefore, it is important to find new strategies to overcome the withdrawal difficulties.      The aim of this study is to test the effectiveness of a novel psychosocial intervention     called PASSE-65+ to facilitate the benzodiazepine withdrawal in the older users, thus     providing a new therapeutic tool to physician.   "
76755|NCT02281162|"     Schizophrenia and bipolar disorders are major public health problems. The second generation     anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable     risk profile as far as movement disorders. However, these drugs are associated with     clinically significant weight gain and metabolic effects. The underlying mechanisms of these     side effects are unclear, however in our preliminary studies with schizophrenic patients on     atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present     in about 50% of this population. Given the considerable heterogeneity among the patients on     atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we     propose that patients with schizophrenia who gain weight on atypical antipsychotic     medications are vitamin D-deficient. This hypothesis will be tested in patients with     schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4     months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with     antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain     weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein     expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood     cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin.   "
76756|NCT02281149|"     Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to     95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the     local recurrence rate after irradiation post- lumpectomy is also associated to a best global     survival than only the surgery. The adjuvant radiotherapy after partially or totally     mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer     Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our     practices under this breast adjuvant radiotherapy.   "
76757|NCT02281136|"     The purpose of this study is to evaluate the potential for systemic exposure of     aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in     patients with multiple actinic keratoses (AK) involving the upper extremities.   "
76758|NCT02281123|"     Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early     joint damage. Approximately 8% of patients have chronic arthropathy resembling to the     rheumatoid polyarthritis. The EchoCHIK study we propose is in the context of the epidemic in     Martinique which began in January 2014. It should give a better understanding of arthritis     and juxtaarticular of CHIK and look for signs that may allow ultrasound predict the evolution     of chronic arthropathy of CHIK.   "
76759|NCT02281110|"     The purpose of this registry is to collect real life information and to document the     performance and user friendliness of iFR in daily diagnostic practice and treatment     strategies for MVD patients undergoing cardiac catheterization.   "
76760|NCT02281097|"     ﻿Some patients experience high heart rates and symptoms of light-headedness, fatigue,     headache during standing despite well maintained blood pressure.      These patient are disabled and can't be in upright position for a longer time. The purpose of     this study is to test whether electrical stimulation of a nerve through a skin of the ear may     improve heart rate response and reduce disabling symptoms.   "
76812|NCT02280408|"     Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has     affected several thousand people. There is no approved effective way to treat or prevent     Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola     vaccine VSV ZEBOV (BPSC-1001) to see if it is safe and to see how it affects people's immune     system.   "
76813|NCT02280395|"     This is a double-blind, randomized, parallel-group, controlled, multi-center study to     evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to     sterile saline (Group B) in adult subjects undergoing abdominal surgery.   "
76762|NCT02281071|"     The benefits of microsurgical approaches in periodontal therapy have been described. The main     focus of this study is to determine if using microsurgical LMCAF technique would improve the     outcomes of the therapy for the Miller Class III isolated recession-type defects.      Six months results of this study showed that LMCAF with microsurgical approach offered better     complete and mean root coverage results over macrosurgical LMCAF technique. The superior     effect of microsurgical approach on post-operative morbidity can make this technique more     preferable for the patients who expected comfortable postoperative period.      This study supports that using the microsurgical aproach with LMCAF procedure significantly     affects the clinical and patient-centered success of treating Miller Class III isolated typed     defects.   "
76763|NCT02281058|"     Vitiligo is a chronic autoimmune disease with evidence of CTLA-4 involvement. We are     performing a pilot study for the treatment of new onset or actively progressing vitiligo with     abatacept to determine if weekly self-injections of medication lead to clinical improvement     in vitiligo lesions.   "
76764|NCT02281045|"     It is not known whether the combination of a heparin-grafted membrane plus citrate-containing     dialysate is a valid alternative to regional citrate anticoagulation. This is a cross-over     non-inferiority trial comparing these two anticoagulation strategies   "
77018|NCT02277730|"     Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and     fetal adverse effects. The investigators developed a double-vasopressor automated system     incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step     algorithm.   "
76765|NCT02281032|"     BACKGROUND Nursing homes are important locations for palliative care. Through comprehensive     geriatric assessments (CGAs), evaluations can be made of the palliative care needs of nursing     home residents. The interRAI Palliative Care instrument (interRAI PC) is a CGA that evaluates     diverse palliative care needs of adults in all healthcare settings. The evaluation results in     Client Assessment Protocols (CAPs: indications of problems that need addressing) and Scales     (e.g. Palliative Index for Mortality (PIM)) which can be used to design, evaluate and adjust     care plans. This study aims to examine the effect of using the interRAI PC on the quality of     palliative care in nursing homes. Additionally, it aims to evaluate the feasibility and     validity of the interRAI PC.      METHODS This study covers phases 0, I and II of the Medical Research Council (MRC) framework     for designing and evaluating complex interventions, with a longitudinal, quasi-experimental     pretest-posttest design and with mixed methods of evaluation. In phase 0, a systematic     literature search is conducted. In phase I, the interRAI PC instrument is adapted for use in     Belgium and implemented on the BelRAI-website and a practical training is developed. In phase     II, the intervention is tested in fifteen nursing homes. Participating nursing homes fill out     the interRAI PC during one year for all residents receiving palliative care. Using a     pretest-posttest design with quasi-random assignment to the intervention or control group,     the effect of the interRAI PC on the quality of palliative care is evaluated with the     Palliative care Outcome Scale (POS). Psychometric analysis is conducted to evaluate the     predictive validity of the PIM and the convergent validity of the CAP 'Mood' of the interRAI     PC. Qualitative data regarding the usability and face validity of the instrument are     collected.      DISCUSSION This is the first study to evaluate the validity and effect of the interRAI PC in     nursing homes, following a methodology based on the MRC framework. This approach improves the     study design and implementation and will contribute to a higher generalizability of results.     The final result will be a psychometrically evaluated CGA for nursing home residents     receiving palliative care.   "
76766|NCT02281019|"     The purpose of this study is to document indications for cholangioscopy and clinical utility     of the SpyGlass Direct Visualization System throughout the AMEA (Asia, Middle-East, Africa)     region when used per standard of practice.   "
76767|NCT02281006|"     This study evaluates whether a gel containing sodium thiosulfate deposited via a     trans-tympanic injection on the round window of the middle ear could reduce the ototoxicity     caused by the drug Cisplatin among patients with head and neck cancer treated by     chemoradiation. One ear selected randomly will be treated while the other will serve as     control.   "
76768|NCT02280993|"     To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in     patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse     is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior     to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose     fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage     only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and     autologous stem cell transplantation (ASCT) is expected to improve progression free survival     (PFS) and overall survival (OS).   "
76769|NCT02280980|"     Individuals older than 60 years old, discharged after suffering brain stroke with referral to     the rehabilitation outpatient clinic, will be assessed for orthostatic balance. Patients with     positive Romberg test are invited to participate in the trial. Participants will be     randomized to either the current rehabilitation protocol or to an supplemental intervention     focused on oculomotor and gaze stability exercises to be applied at home for three weeks.     Participants will be assessed with standardized, validated tools.   "
76770|NCT02280967|"     The last ten years sexually transmitted infections (STI) have substantially increased among     adolescents. STI can lead to individual suffering and have a negative effect on the future     reproductive health and also increase the need for health care, thus it is important to     reduce the number of STIs. HPV vaccination is included in the school-based vaccination     program since 2012, a catch-up vaccination is offered to older girls and young women aged     13-25. School nurses have a key role regarding information about HPV and HPV vaccine, and the     school-based vaccination program has a substantial higher coverage rate. Knowledge is an     important factor associated with attitude to preventive methods against HPV. In previous     studies the results indicate that young people have low awareness of HPV and the HPV vaccine.     Interventions can decrease sexual risk taking and influence the intention to receive HPV     vaccination and increase the use of condom.      The aim of this study is to increase primary prevention of human papillomavirus (HPV) by     promoting HPV vaccination and increase condom use among upper secondary students. The aim is     also to increase the knowledge about HPV, risk and prevention.   "
76771|NCT02280954|"     According to the World Health Organization, cancer is a leading cause of death in men and     women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains     the best option for patients presenting with operable Stage I or II cancers, however the five     year survival rate for these candidates remains at a dismally low. The high rates of     recurrence suggest that surgeons are unable to completely detect and remove primary tumor     nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By     ensuring a negative margin through near-infrared imagery it would be possible for us to     improve the rates of recurrence from patients and thus overall survival.   "
76772|NCT02280941|"     This study is being done to compare the blood flow measurements obtained with the SPECT and     PET imaging scans. Measurements such as myocardial blood flow (MBF) and myocardial flow     reserve (MFR) are analyzed on PET scans. These measurements give the doctors more precise     information in diagnosing heart problems. SPECT scans, with new camera technology and     computer software, now have the potential to also give this additional information. The study     is investigating how well the blood flow measurements from SPECT compared to PET.   "
76775|NCT02280902|"     Infections represent the first cause of death and of morbidity in people treated for     immunologic and inflammatory diseases with corticosteroids, immunosuppressive drugs or     biotherapy. Epidemiological, clinical, biological and therapeutic determinants of these     infections are poorly understood. There is no recommendation for the prevention and treatment     of infections in this particular field.      Purpose : Recent therapeutic trials evaluating immunosuppressive and biotherapy     (cyclophosphamide, mycophenolate mofetil, rituximab, belimumab) in the field of immunologic     and inflammatory diseases have found a risk of severe infection of 7 to 18% during the first     year after the beginning of the treatment. Thus, the main objective of the study is to     describe the incidence and risk-factors for infections in people treated with such agents for     immunologic and inflammatory diseases.   "
76776|NCT02280889|"     Congenital melanocytic nevi (CMN) are a quite common congenital disorder. Over years,     surgical excision was proposed to the patients because transformation into a malignant skin     tumor (melanoma) was feared. Recent data proof that the risk for malignancy was     overestimated. Nowadays still a lot of patients express their wish for surgical removal out     of aesthetic reasons and psychological impacts. Many patients and families experience     stigmatization because of the nevus. To proof a medical indication for surgical removal the     investigators want to evaluate the quality of life and stigmatization before and after nevus     surgery.   "
76777|NCT02280876|"     To evaluate the efficacy of ApE coated tablets, on the relapse rate in a group of relapsing     remitting multiple sclerosis (RRMS) patients, as compared to a placebo group in a period of     12 months. This study will also determine the safety and tolerability of the drug     administered over interferon beta vs. administration of a placebo formulation (also over     interferon) during the evaluation period. Response will be assessed and measured by daily     self patient recording, monthly clinical neurologist, and every three months serological and     magnetic resonance parameters.      Place of Study: National study in Chile with one center at the Regional Hospital in the city     of Valdivia, including 30 patients enrolled by their respective neurologists.   "
76778|NCT02280863|"     The primary objective of this pilot study is to evaluate the safety and efficacy of a hybrid     closed loop (HCL) system in participants with type 1 diabetes. This HCL system utilizes the     PID-IFB controller during the day and night in a closely monitored outpatient environment to     allow assessment of the practical aspects of using the system for both the participant with     diabetes and their parent or designated remote monitor.   "
76779|NCT02280850|"     Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat     chronic stable angina (syndrome of blood stasis resistance), and the result will be used for     the basis of later Ⅳ clinical trial.   "
76780|NCT02280837|"     In this study, the investigators hypothesized that significant proportion of patients with     coronary artery disease (CAD) has reduced capacity of glucagon-like peptide-1 (GLP-1)     secretion, which is detectable as blunted response of plasma active GLP-1 level to oral     glucose loading and that reduced GLP-1 secretory function is associated with increased     severity of coronary artery stenosis but not with classic risk factors for CAD. To test this     hypothesis, the investigators will analyze correlation between GLP-1 secretory capacity and     severity of coronary artery stenosis determined by Gensini Score (GS), an established score     system for coronary artery stenoses. Additionally, the investigators will analyze     relationship between level of total GLP-1 and severity of coronary artery stenosis to     determine how it is different from the active GLP-1 - coronary stenosis relationship.   "
76781|NCT02280824|"     Background:      - Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that     are too small and are too sick for standard techniques. But they may benefit from a new     technique called transcaval TAVR. For this technique, doctors make a hole between the largest     vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they     replace the valve through a tube they put in the groin vein. Then they close the hole between     the vein and the artery using a device designed to close holes in the heart. This study tests     the device for this new, off-label use.      Objective:      - To further study the safety and effectiveness of transcaval TAVR.      Eligibility:      - Adults age 21 and older who would benefit from TAVR but for whom standard techniques are     not suitable.      Design:        -  Participants will be selected by a team of heart specialists and others.        -  Participants will have a computed tomography (CT) scan with or without contrast dye.        -  Participants will have blood tests.        -  Participants will have transcaval TAVR.        -  Participants will receive the same standard care as for all patients with TAVR.        -  Participants will also have another CT scan, or an MRI or ultrasound, before they leave          the hospital, and again after about 30 days and after about 12 months.        -  Participants will be contacted 1 and 6 months afterwards and will have another visit 1          year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a          physical exam.   "
76782|NCT02280811|"     Background:      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for     treating patients with cancer that involves taking white blood cells from the patient,     growing them in the laboratory in large numbers, genetically modifying these specific cells     with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells     back to the patient. This type of therapy is called gene transfer. Researchers want to test     this on human papilloma virus (HPV)-associated cancers.      Objective:      - The purpose of this study is to determine a safe number of these cells to infuse and to see     if these particular tumor-fighting cells (Anti-HPV E6) can shrink tumors associated with HPV     and test the toxicity of this treatment.      Eligibility:      - Adults age 18-66 with an HPV-16-associated cancer.      Design:        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of          Health (NIH) clinical Center and undergo a history and physical examination, scans,          x-rays, lab tests, and other tests as needed        -  Leukapheresis: If the patients meet all of the requirements for the study they will          undergo leukapheresis to obtain white blood cells to make the anti HPV E6 cells.          {Leukapheresis is a common procedure, which removes only the white blood cells from the          patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the anti HPV E6 cells and aldesleukin. They will stay          in the hospital for about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits take up to 2 days.   "
76783|NCT02280798|"     Do differences in endometrial gene expression exist after different protocols of endometrial     preparation for embryo transfer? The recent apparition of endometrial receptive arrays     technology let us know if endometrial is receptive or not in patients with some problems of     infertility as implantation failure, for that we want to know if this technology would tell     us if the different kind of protocols for endometrial preparation origin differences that     could explain some of the founded results.   "
76784|NCT02280785|"     Brentuximab vedotin is an antibody-drug conjugate targeting CD30, one of surface antigens     expressed in lymphoma cells. Fanale MA, et al. reported the results of a phase I study with     weekly dosing of brentuximab vedotin in patients with relapsed/refractory CD30-positive     hematologic malignancies (Clin Cancer Res. 2012) showed tumor regression in 85% of patients.     Thus, the overall objective response rate was 59% (24/44) including 34% (n = 14) of complete     remissions. This study mainly included Hodgkin lymphoma (n = 38) and anaplastic large cell     lymphoma (n = 5). However, its efficacy in other types of NHL has never been reported     although this study enrolled one patient with peripheral T-cell lymphoma not otherwise     specified (PTCL-NOS).      CD30 (TNFRSF8) is a transmembrane glycoprotein of the tumor necrosis factor receptor (TNFR)     superfamily, and it is involved in signal transduction via the activation of the NF-κB     pathway and the mitogen-activated protein kinases (MAPKs), ultimately modulating cell growth,     proliferation and apoptosis. CD30 is a non-lineage-specific activation marker expressed by     scattered B and T immunoblasts. In addition, a subset of cases in virtually all T-cell     lymphoma entities may also express CD30 but at variable and generally lower levels. In fact,     a recent study in 22 patients with extranodal NK/T-cell lymphoma showed 75% of positive rate     of CD30 expression (75%). Moreover, CD30 expression was also documented in the tumor sample     of EB virus positive diffuse large B-cell lymphomas (EBV + DLBCL) of the elderly (28.9%,     11/38). Therefore, Brentuximab vedotin may have potential benefits for patients with     CD30-positive NHL other than anaplastic large cell lymphoma such as CD30-positive PTCLs, NOS.     Considering the role of CD30 in signal transduction pathway associated with tumor growth and     proliferation, its expression may be associated with tumor aggressiveness. In accordance with     this, it is more likely that relapse or refractory NHLs may have CD30 expression, and the     potential benefits of this promising agent as a salvage therapy deserve to be further     investigated in these patients who have high risk of treatment failure. Thus, we designed a     phase II study for relapsed or refractory NHL patients. This study is to explore the safety     and activity of dosing once every 3 weeks of Brentuximab vedotin in patients with relapsed or     refractory CD30-positive NHL other than anaplastic large cell lymphoma.   "
76785|NCT02280772|"     Glucomannan (GNN), a water-soluble dietary fiber derived from the plant Amorphophallus     konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its     actions are unclear. Nonetheless, it has been shown that GNN slows gastric emptying by     forming a viscous gel of large volume, which increases the feeling of satiety. Current     evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed trials     performed in children are needed to assess the efficacy of this modality. We aim to     systematically evaluate the efficacy of GNN consumption for the management of overweight and     obesity in children.   "
76786|NCT02280759|"     Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is     increasingly being marketed as an antidiarrheal drug. A randomized, double blind,     placebo-control trial was performed to assess the effectiveness of GT in management of     children with acute gastroenteritis.   "
76787|NCT02280746|"     BACKGRUOUND: Autism spectrum disorder (ASD) is a common condition. The etiology of ASD     remains unknown. Recent studies suggest a link between elimination diets and severity of     autistic symptoms. The possible effects of a gluten-free diet (GFD) on symptoms remain     unknown.      AIM: The aim of the study is to evaluate the impact of gluten challenge on the autistic     symptoms in children with autism spectrum disorders (ASD) and on a gluten-free diet (GFD) in     comparison to individuals continuing GFD.      METHODS: 70 children with ASD aged 3-5 and 11/12 remaining on GFD for at least 8 weeks will     be randomly assigned to gluten-free and gluten-challenge diet.   "
76788|NCT02280733|"     More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to     transmit structured data on all patients followed with chronic wounds and ulcers (e.g.     diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and     traumatic wounds). Data are collected at point of care including adherence to wound care     quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).   "
76789|NCT02280720|"     The purpose of this study is to compare vascular healing of the stented segment after     deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and     Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring     percutaneous coronary intervention.        1. Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium          Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the          index procedure.        2. Comparison of intravascular coronary flow reserve measurement to non-invasive          transthoracic echocardiography-derived coronary flow reserve measurement.        3. Comparison of epicardial vasodilation to coronary microcirculatory vasodilation   "
76790|NCT02280707|"     This study, randomized, delivered, and analyzed at the school level, evaluated the effect of     simple, structural changes to school lunch rooms to make drinking water easier for students     during lunch time. Half of the schools received posters promoting drinking water and     installed cup dispensers stocked with cups next to lunchroom water fountains, while the other     half received no intervention. The intervention outcomes were average water consumption and     the proportion of students in the lunchroom who opted to drink water, as well as the     proportion of students with sugary drinks at lunch. No identifying information on individual     children was collected.   "
76791|NCT02280694|"     This study investigates the activity of a new regimen of treatment for patients with     metastatic colorectal carcinoma. This includes a combination of well-known chemotherapy     agents and anti-inflammatory agents, when administered orally at low daily doses and without     planed brakes (Low Dose Metronomic regimen), in contrast with the conventional and already     exhausted regimens of treatment at Maximal Tolerated Doses (MTD) which required pre-planned     brakes between treatment days.   "
76792|NCT02280681|"     To gain insight by means of a discrete choice experiment questionnaire into characteristics     of medically assisted reproduction (MAR) with artificial gametes (AGs) valued by couples     confronted with ovarian failure and their physicians and the trade-offs they make between     these treatment characteristics.   "
76793|NCT02280668|"     The purpose of our research is to investigate the effects of applying cold therapy, or     icing, to injured muscles in terms of strength recovery and muscle soreness amelioration     following unaccustomed exercise.   "
76809|NCT02280447|"     The background of the clinical trial is the overall aim of the World Health Organization     (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated     polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to     become available in low resource third World countries.      The primary objective of the phase I/II clinical trial is to provide proof of concept (POC)     that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically     significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the     booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI,     1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI.      A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months     and 5 years of age according to the Danish vaccination program will be included in the trial.   "
76794|NCT02280655|"     Transfusion of red blood cells is often used in critically ill patients with low red blood     cell counts to prevent disease progression and death. Recent studies suggest that the use of     aged versus fresh red blood cells are associated with worse clinical outcomes. There is     evidence that red blood cells work with the cells lining our blood vessels to produce a     variety of substances that normally cause arteries to relax and increase blood supply. Two of     these substances are called nitric oxide (NO) and endothelium-derived hyperpolarizing factor     (EDHF). The investigators are trying to determine the nature of these substances in human     beings when they are transfused aged versus fresh red blood cells. The purpose of the     study is to test the effects of transfusing aged versus fresh red blood cells in     volunteers with traditional cardiovascular risk factors (high blood pressure, diabetes, high     cholesterol, and tobacco use) on 1) the degree of relaxation in the arteries and subsequent     changes in blood flow, 2) blood levels of oxidant molecules, 3) inflammation, and 4) stem     cells.      A similar study with healthy volunteers are further described in NCT00838331.   "
77019|NCT02277717|"     The purpose of this study is to evaluate the safety of a new medicinal drug SYD985 at     different dose levels in patients with cancer, to understand how SYD985 is handled by the     body and to evaluate the effect of SYD985 on the cancer.   "
76795|NCT02280642|"     The purpose of this study was to determine if delayed dosing of recombinant human     papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls     elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as     measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine     delivered according to the recommended dosing schedule.      This was a prospective observational study of healthy 9-18 year old female patients receiving     either a second or third dose of HPV vaccine as part of their well child care. Immune     responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after the third     dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when     administered at naturally occurring longer dosing intervals to the immune response to HPV     vaccine when administered as routinely recommended.      In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered     vaccines by injection were randomized to receive either the HPV vaccine first or their     concomitantly administered vaccines first. Pain following vaccination was assessed in each     arm using the Faces Pain Scale - Revised.      Please note: This record refers only to the observational portion of the study. Please refer     to NCT00862810 for the results of the randomized portion of the study.   "
76796|NCT02280629|"     The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day     delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission     in patients with ulcerative colitis (UC)   "
76797|NCT02280616|"     The purpose of this study is to assess the efficacy of a low and high dose of a budesonide     effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction     treatment of active eosinophilic esophagitis.   "
76798|NCT02280603|"     This study is designed to explore the efficacy and safety of DA-4001 after topical     application in male patients with androgenetic alopecia      Design : Randomized, double-blind, active-controlled study      Investigational Product : Finasteride, minoxidil   "
76799|NCT02280590|"     Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with     hyperlipidemia      - 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose,     noninferiority, multicenter, phase 4 design   "
76800|NCT02280564|"     FL3X is an integrated diabetes self-management system that incorporates modern cell phone     technology with behavioral modification approaches to improve diabetes self-management in     high-risk youth. Utilizing such approaches will increase adherence to diabetes management     behaviors and improve glucose control by providing increased autonomy over diabetes care.   "
76801|NCT02280551|"     Parents can positively influence their children's alcohol use. One strategy they use is to     provide their children with alcohol, believing it is the best way to teach their children how     to drink responsibly. The impact of parental supply is not well understood and may be     unintentionally harmful. This study will research the consequences of parental supply within     the broader context of parent, child and peer relationships. It will help to determine how     parental supply influences the different patterns of adolescent alcohol consumption over     time, providing essential information to help parents prevent alcohol misuse in their     children. Parents can play a pivotal role in prevention of alcohol misuse, but at present we     don't know exactly how.   "
76802|NCT02280538|"     The present study is designed to test the hypothesis that Intra-Articular Hyaluronic Acid     (IAHA) is superior to placebo in slowing structural progression and on long term symptomatic     effect in primary knee Osteoarthritis (OA) patients.      The investigators will perform a multicenter double-blind, randomized, placebo-controlled,     parallel group trial.   "
76803|NCT02280525|"     The goal of this clinical research study is to find the highest tolerable dose of immune     cells called natural killer (NK) cells that can be given with chemotherapy to patients with     CLL. Researchers want to learn if adding NK cells will be effective in treating the disease.     The safety of this will also be studied.      NK cells may kill cancer cells that remain in your body after your last chemotherapy     treatment. The NK cells will be separated from umbilical cord blood. The device used in the     laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then     be grown in the lab to increase the number of NK cells that can be given to you by vein.   "
76804|NCT02280512|"     In Taiwan, about 75.92% of the elderlies above 65 years old suffered from chronic diseases or     major diseases, especially in circulatory system. Thus, dramatic hemodynamic change is often     observed in surgeries in this population. Due to osteoporosis and high-prevalence     morbidities, trauma with fracture is quite common. These elderlies are more vulnerable to     have complications, poor prognosis and decompensated organ functions.      The investigators would like to observe the perfusion of different tissue intra-operatively,     and to find the correlation with surgical outcome. There are many non-invasive hemodynamic     monitors nowadays. In our study, the investigators will use noninvasive cardiac output     measurement(NICOM), and non-invasive transcutaneous near infrared spectroscopy(NIRS) to     observe hemodynamic change and tissue perfusion. After the surgery, the duration in ICU will     be recorded. A questionnaire, SF-36, will be mailed to the patients 2 months after the     surgery to measure the psychometric status.   "
76805|NCT02280499|"     Overall study design:      This study is a prospective, multicenter, postmarket clinical observation to validate the     PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder     arthroplasty in terms of radiographic and clinical performance as well as long-term     survivorship over 10 years.   "
76814|NCT02280382|"     The main purpose of the feasibility study is to identify the patient experience of Femmeze®     which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for     women with obstructive defaecation. The investigators want to investigate implementation and     preliminary effectiveness of the device. The method of investigation will be a pre-post     intervention design, which involves asking 30 women to use Femmeze® over a period of 8 weeks.     This is an academic study on a labelled indication     (http://www.nres.nhs.uk/search/?q=medical+devices).   "
77014|NCT02277782|"     The objective of this study is to evaluate the effect of intrathecal hydromorphone on the     duration of labor analgesia and the incidence of epidural-associated temperature increase in     laboring parturients. We hypothesize that intrathecal administration of longer-acting     hydromorphone will:        1. Prolong the duration and improve the quality of analgesia in labor, and        2. Decrease the incidence of epidural-associated temperature increase in labor.   "
76815|NCT02280369|"     The automated inflatable abdominal binder is an investigational device for the treatment of     orthostatic hypotension (low blood pressure on standing) in autonomic failure patients. The     purpose of this study is to evaluate the performance of the binder in detecting body posture     during different types of human motion patterns and activities of daily living, and to     develop new (and better) ways to detect upright posture. In particular, the investigators     want to determine if activities of daily living, normally encountered by patients (lying     down, sitting, standing, walking, and climbing up and down steps), interfere with the     detection of upright posture used to trigger the device. Studies will be conducted in healthy     subjects because the main purpose of this study is to evaluate posture detection rather than     treating orthostatic hypotension.   "
76816|NCT02280356|"     The purpose of this study is to test the safety and side effects of ultra-hypofractionated     radiation therapy when used after brachytherapy (radiation implants). This treatment delivers     a higher radiation dose with each treatment over a shorter period of time.   "
76817|NCT02280343|"     Inhalation of dust containing asbestos results in a process of interstitial pulmonary     fibrosis called asbestosis. The Forced Oscillation Technique (FOT) evaluates the respiratory     mechanics describing resistive, elastic and inertial properties. We believe that this     technique may contribute to the early diagnosis of asbestosis.   "
76818|NCT02280330|"     Iodine deficiency remains widespread worldwide with children as among the vulnerable groups     considering their stage of growth and development. In the Philippines, current data shows an     optimal status among schoolchildren, however no data exists on iodine status nor intake of     preschool children. One recent approach to improvement of the vitamin and mineral status of     the population is home fortification using micronutrient powder or MNP. This contains 15     vitamins and minerals, including iodine and iron. Current guidelines exist for MNP use to     improve iron status and reduce anemia among infants and young children 6-23 months old, but     did not mention use among preschoolers such as those in day care centers. This study,     therefore, aims to compare the iodine status and growth of day care children given MNP for 6     months.   "
76819|NCT02280317|"     Dose finding safety study of VAL201 in cancer patients.   "
76820|NCT02280304|"     The goal of this study is to learn more about how Inner Resources for Veterans (IRV)     meditation therapy helps Veterans with Post Traumatic Stress Disorder (PTSD) and mild     traumatic brain injury (mTBI). PTSD is a disorder that occurs after exposure to one or more     traumatic experiences. People with PTSD may experience anxiety, pay extra attention to their     surroundings, involuntarily remember their traumatic experiences, and/or want to avoid     situations where these symptoms are increased. MTBI may result from being in a blast     explosion, with pressure from the blast potentially disrupting the brain's structure and     function. At this time, it is not well known how PTSD and mTBI may affect each other.      In this study, the investigators will be looking at the behavioral and neurological changes     (changes in the brain) and the reductions in PTSD symptoms that may come from participating     in this treatment. The investigators are interested in determining if treatment does reverse     changes in the brain caused by PTSD and mTBI. To help the investigators understand changes in     how the brain functions, the participants will complete a functional magnetic resonance     imaging (fMRI) scan before and after either a 8-week course of IRV or 8 weeks of education     about PTSD and mTBI. Participation will help the investigators understand how therapy for     PTSD and mTBI impacts the brain's response to emotions and therapeutic processes.   "
76821|NCT02280291|"     Peripheral nerve blocks have been well studied in the literature with generally good results     for controlling post operative pain following orthopaedic surgery. Regional anesthesia has     many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well     as analgesia that continues into the post-operative period. These regional blocks are also     effective in controlling pain in the immediate post-operative period. However, as the block     wears off, patients begin experiencing increased pain. Compared to patients treated without     regional blocks, these patients will often experience a rebound pain--pain occurring 12-24     hours after surgery that is subjectively worse than that in patients treated without regional     blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in     order to provide sustained pain control post-operatively. Preoperatively, patients will be     randomized into a single shot peripheral nerve block versus a continuous infusion of     peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue     Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain     medication taken will be recorded. Patients will be contacted at certain time intervals     postoperatively to assess their pain scale and pain medication intake. Patients will be seen     for routine post-operative follow-up visits where they will be assessed for satisfaction,     pain, residual neurological symptoms, and signs of infection.   "
76822|NCT02280278|"     We hypothesize through this randomized, prospective, single center adjuvant study, that     cytokine-induced killer cell in patients with stage III colon cancer can improve survival in     this patient population over control. Stage III colon cancer patients can benefit most from     adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell     therapy can improve the survival rate of stage III colon cancer patients.   "
76831|NCT02280161|"     This research trial studies germ-line mutations in blood and saliva samples from patients     with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory     may help doctors learn more about how inherited genetic mutations can affect cancer     predisposition (an inherited increase in the risk of developing cancer), their impact on     treatment response, and their role in cancer development.   "
76832|NCT02280148|"     The purpose of this study is to assess the driving and cognitive ability of gastrointestinal     endoscopy patients at different time points after intravenous anesthesia (propofol for     example), and to explore whether the driving and cognitive ability have a relationship with     the blood concentration of propofol or not.   "
77015|NCT02277769|"     This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the     efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic     dermatitis (AD).   "
77141|NCT02276131|"     A human factors and home use study to assess whether subjects with diabetes and their     caregivers can understand feedback received from the Vigilant Diabetes Management Application     about their blood glucose patterns and whether the decisions made in response to device     feedback are made in accordance with the intended use.   "
76823|NCT02280265|"     Hemophilia A is an X-linked recessive, congenital bleeding disorder caused by deficient or     defective coagulation factor VIII (FVIII). Prophylaxis is recommended as the standard of care     for boys with severe haemophilia by WHO and World Federation Of Hemophilia (WFH). The     efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with     hemophilia has been confirmed in well-designed clinical studies.To keep the factor level     above 1%, the standard dosage for patients with severe hemophilia A is 20-40 Units     /kg/infusion (average 30 Units /kg) every other day or three times a week. This dosage has a     very high consumption of factor, up to 5000-6000 international unit (IU)/kg/year. The high     consumption of factor and cost present a major barrier to use the standard prophylaxis in     many countries particularly in the developing world.      In China the majority of boys with severe hemophilia A can only pay for on-demand treatment     or low-dose prophylaxis. Ao after the affordability of patients was solved and many patients     will get more chance to receive standard prophylaxis.      This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and     QoL outcomes in subjects using ADVATE(Recombinant Human Coagulation Factor VIII for     injection) standard prophylaxis under the conditions of routine practice.   "
76824|NCT02280252|"     The need to understand LABC is especially compelling in populations and countries with     limited resources, where breast cancer incidence is relatively low, but mortality is     comparably high. In these settings access to appropriate cancer care is characteristically     limited or often plainly nonexistent. In contrast to economically developed nations, where on     average fewer than 20% of women present with breast cancer at advanced stages, LABC and     metastatic disease are the most common stages at presentation in 50% or more women in Latin     America, Asia and Africa.   "
76825|NCT02280239|"     The intensive care unit (ICU) team needs to know what effects acetaminophen has in critically     ill patients. Acetaminophen is better known as Tylenol. It is the drug given to reduce fever.     Most research that has looked at how safe and effective this drug is, has been done with     healthy people. Those studies tell us it is safe and works well to bring down fever.      This may not be true for the ICU patient. Some research found acetaminophen was not as good     at reducing fever as expected in the ICU. Fever helps to fight infection so it may help     patients get better, but it is also stressful. When you have fever, you to need more oxygen,     and your heart beats faster. If you have a fever after brain injury, you are less likely to     make a full recovery. In patients with brain injury, a weak heart or trouble breathing we     should treat fever. If we can predict how well acetaminophen will reduce fever, we can decide     if this drug is enough, or other treatments are also needed.      If you do not have problems with your brain, heart, or lungs, it is safe to not treat fever.     When you give this drug to treat fever, the body cools itself by sweating, and bringing hot     blood to the skin's surface. These changes do not affect healthy people. Research suggests     ICU patients may be at risk for sudden drop in blood pressure.      Our study will answer 2 questions: 1) When acetaminophen is given to treat fever in ICU     patients, are they more likely to have a drop in blood pressure? 2) How much will     acetaminophen reduce fever in ICU patients? We will study ICU patients with a fever who can     safely get, or not get this drug. This information will help us decide when and how to treat     fever in the ICU.   "
76826|NCT02280226|"     Former studies revealed a distinct pattern of changes in circulation during deliberate apnea.     Blood pressure rises significantly often accompanied by bradycardia. Further studies     confirmed a massive increase of total vascular resistance as it also happens in shock to     maintain perfusion of heart, lung and brain. This study is to determine the exact alterations     of the cardiac function during this reaction, show the redistribution of blood volume in     apnea and evaluate possible longterm effects on the central nervous system caused by repeated     apnea via magnetic resonance imaging.   "
76827|NCT02280213|"     Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for     infant intubation during resuscitation with and without chest compressions.   "
76828|NCT02280200|"     The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on     the primary outcome of peak walking time (PWT) in patients with peripheral artery disease     (PAD).   "
76829|NCT02280187|"     It is a phase IV, national, multicenter, observational, retrospective study collecting data     from patient medical files in French spinal centers.      The aim of the study is to describe the real world use of InductOs in Spine fusion in France.      Approximately 10 French centers will enroll 400 patients. The retrospective review of records     will focus on patients who have undergone a spinal fusion surgery. Patient should be     considered for enrollment if he/she has been treated with InductOs between January 1, 2011     and 31st December 2012.   "
76830|NCT02280174|"     Overproduction of intestinally derived triglyceride-rich lipoproteins (TRLs) (chylomicrons)     has recently been described in type 2 diabetes (T2DM), as is known for hepaticTRL     (very-low-density lipoprotein) production.      There is an interest in identifying therapies that would favourably influence postprandial     concentrations of lipids in T2DM.      linagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has     been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes     mainly through incretin hormone-mediated improvements in islet function.      Although clinical studies to date indicate that fasting lipid levels are minimally affected     by DPP-IV inhibitor treatment, animal studies suggested that DPP-IV inhibition reduce     intestinal triglycerides (TG) absorption and apolipoprotein (apo) production and increased     chylomicron catabolism. Interestingly, a recent study supporting this hypothesis showed that     vildagliptin therapy was able to reduce postprandial intestinal TRL particles in patients     with type 2 diabetes. Recently, it had reported that sitagliptin treatment significantly     reduced plasma apoB-48 and TG concentrations in the postprandial state.      The action of DPP-IV inhibitors may be explained by insulin secretion or action of     glucagon-like peptide (GLP-1) on metabolism of TRL.      Therefore, the present study was designed to examine the effects of linagliptin treatment     (LT) vs standard treatment (ST) on the metabolism of TRL apoB-48 in patients with type 2     diabetes over a 12 weeks-period.      The investigators will study the patients in three different moments defined as: Time 0 (2     weeks before LT or ST, Time 1 (4 weeks after LT or ST), Time 2 (12 weeks after LT or ST).     With areas under the curve (AUCs) of apoB48 in postprandial conditions.   "
81246|NCT02222493|"     The study will assess the efficacy and safety of PF-06438179 and infliximab in combination     with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate     response to methotrexate.   "
76834|NCT02280122|"     Background: Untreated periodontal disease may influence general health. However, how may a     physician who is not trained in periodontal probing detect untreated periodontitis? Activated     matrix metalloproteinase-8 (aMMP-8) in saliva correlates with periodontal probing parameters.     Thus, sensitivity and specificity of a chair-side test for activated matrix     metalloproteinase-8 to detect periodontitis was evaluated.      Methods: Thirty cases (untreated chronic periodontitis; 15 generalized moderate and 15     generalized severe) and 30 controls (probing pocket depths ≤ 3 mm, vertical probing     attachment level ≤ 2 mm at < 30% of sites) were examined periodontally. Further, the     activated matrix metalloproteinase-8 test was performed. The test kit becomes positive with ≥     25 ng/ml activated matrix metalloproteinase-8 in the sample.   "
76835|NCT02280109|"     This is an open label comparative study of tenofovir gel and film in 10 healthy sexually     active women without active female genital tract disorders. The women will receive a single     dose of each formulation - tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) and     tenofovir film (1.3%;40 mg) - in a crossover study design to determine the pharmacokinetics     of tenofovir in the blood, cervical tissue, and cervicovaginal fluid (primary objective).   "
76836|NCT02280096|"     Twenty four RRMS patients over the age of 18, with similar degree of disability, and with an     evolution of at last 6 months, who are in first-line immunomodulatory therapy and have a     stable disease (no more than one outbreak per year) will be included in the present study.     Patients will be administered a neuropsychological test battery selected for this study and     divided into two sessions of one and a half-hour each. Emotional state will be assessed with     the Beck Depression Inventory in a different session. Cognitive impairment is defined as the     alteration of two or more neuropsychological tests. Patients will be divided randomly into     two groups where one will receive placebo and the other one 4-AP for a period of four months     in increasing doses.   "
76837|NCT02280083|"     This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare     Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of     treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb     spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will     receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity     is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core     phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after     initial injection. During the extension phase, subjects will accept two follow-up visit (6     weeks). Outcome measures include changes from baseline at every post injection visit as     measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global     Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6     for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters     will also be measured including adverse events, vital signs (pulse and blood pressure) and     clinical laboratory tests (haematology, serum chemistry and urinanalysis).   "
76838|NCT02280070|"     To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in     patients with resectable rectal cancer, and to identify the more promising regimen.   "
76839|NCT02280057|"     The investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome     (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.   "
76840|NCT02280044|"     This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating     the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C.     jejuni.   "
76841|NCT02280031|"     Low-dose aspirin started in the first-trimester has been associated with a decrease of     preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple     pregnancies are considered a risk factor for all those adverse outcomes. The main objective     of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an     improvement of birthweight compared to placebo in twin pregnancies.   "
76842|NCT02280018|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (the     study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944 in     healthy male participants after a single intravenous ([IV] within a vein) dose     administration.   "
76843|NCT02280005|"     This is a prospective, interventional study designed to provide preliminary data on the human     use of the WAK. Up to 10 subjects currently receiving intermittent hemodialysis (HD)     treatment three times per week for end-stage renal disease (ESRD) via an indwelling tunneled     catheter will be studied.   "
76844|NCT02279992|"     This is a randomized pilot study to investigate the ability of a phosphodiesterase-V     inhibitor (vardenafil) to increase the concentration of systemically delivered chemotherapy,     carboplatin, in patients with recurrent malignant gliomas or metastatic brain cancer. This     study will also determine the toxicity and tolerability of a phosphodiesterase-V inhibitor     (vardenafil) in combination with intravenous carboplatin for patients with recurrent     malignant gliomas or metastatic brain cancer.   "
76845|NCT02279979|"     The primary objective of this study is to assess reasonable safety and performance of the     HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic     shock requiring stabilization.   "
76846|NCT02279966|"     To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on     cognitive performance (focusing on the aspect concerning speed of processing, executive     functioning, attention) in working patients with major depressive disorder (MDD).   "
76847|NCT02279953|"     To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable     selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on     cognitive performance (focusing on the aspect concerning speed of processing, executive     functioning and attention) in patients who are in partial or full remission from their Major     Depressive Episode (MDE).   "
76888|NCT02279420|"     This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended     to evaluate the safety and efficacy of treating previous sham subjects in the Essential     pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture     anchors along with diet and exercise). Compliant sham subjects (those who attended all     primary IDE follow-up visits AND who continue to meet eligibility criteria as described in     this protocol) will be offered this active treatment after their 12 month unblinding visit in     the Essential pivotal trial.   "
76848|NCT02279940|"     Atrial fibrillation is a common cardiac arrhythmia and a major risk for ischemic stroke.     Furthermore the risk of stroke is higher in the first month after transient ischemic attack     (TIA)/stroke. Rivaroxaban has been approved by Health Canada over period of last two years     for prevention of stroke and have been found equally effective as oral Vitamin K antagonist.     The foremost benefits of NOAC are reduced intracranial bleeding risk and does not require     coagulation monitoring.      Optimal timing of anticoagulation after TIA/stroke in patients with known non-valvular atrial     fibrillation is not known. The practice is variable and opinion based. The bias for many     stroke physicians and neurologists is to start later (after 1-2weeks) to prevent hemorrhagic     transformation thus possibly exposing the patients to an increased risk of recurrence. The     product monograph for the drug suggest to wait for variable of 3 to 14 days before starting     the NOAC (Waiting period:14 days for dabigatran and rivaroxaban, 7 days for Apixaban after     ischemic stroke and three days after TIA for rivaroxaban). The times have been chosen     arbitrary.      The investigators aim to study incidence of symptomatic hemorrhage in patients with     non-valvular atrial fibrillation who are initiated with new oral anticoagulants early after     TIA and stroke.   "
76849|NCT02279927|"     A prospective study comparing different laser settings used for stone fragmentation during     ureteroscopy   "
76850|NCT02279914|"     This study is a blinded randomized trial to compare two different doses and intervals of     buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks'     gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg     administered 1.5 hours before D&E.      Primary objective: To compare operative times after two different doses and intervals of     misoprostol using a non-inferiority design.      Secondary objectives: To compare the doses and intervals of misoprostol for differences in:     (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if     required; (3) ability to complete the abortion procedure without further cervical     preparation; (4) complications; (5) provider variables including ease of procedure and     satisfaction with cervical preparation; (6) patient variables including pre-operative side     effects, post-operative pain, and acceptability   "
76851|NCT02279901|"     The primary and well-known challenge with continuous positive airway pressure (CPAP) is the     incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely     through emphasizing patient education regarding the risks associated with obstructive sleep     apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and     providing a system of accountability through a follow-up process. With the changing landscape     of healthcare reimbursement which emphasizes achieving positive clinical outcomes,     discovering more automated and self-directed methods of educating and follow-up is needed.      The investigators plan to investigate the impact of adjunct Web education and automated     follow-up on CPAP use and other measurements of patient engagement. The specific aims of this     pilot study are as follows:        1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy          in comparison to usual standard of care.        2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of          healthcare utilization at 3 months after initiation of therapy in comparison to usual          standard of care.   "
76852|NCT02279888|"     The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of     the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial     setting.   "
76853|NCT02279875|"     The purpose of this study is to evaluate the mycobactericidal activity, safety, tolerability,     and pharmacokinetics of 6 doses of linezolid: 300 mg once per day, 300 mg twice per day, 600     mg once per day, 600 mg twice per day and 1200 mg once per day administered orally for 14     consecutive days or 1200 mg administered three times per week for two weeks in adult subjects     with newly diagnosed drug‐sensitive, smear‐positive pulmonary tuberculosis.   "
76854|NCT02279862|"     The purpose of this study is to examine the safety and effectiveness (how well the drug     works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with     metastatic castration resistant prostate cancer.   "
76855|NCT02279849|"     The overarching goal of B'More Healthy Retail Rewards (BHRR) is to develop, implement, and     evaluate a pilot multi-level communications and pricing intervention to improve access to and     consumption of healthy foods in low-income areas of Baltimore City, Maryland. BHRR has three     primary aims: (1) to conduct formative research with representatives of multiple levels of     the Baltimore food environment (i.e., local wholesalers, retail food store owners, and     consumers) in order to select key foods for promotion, and determine appropriate     communications and healthy food price reduction strategies, (2) to pilot the multi-level     program with 2 local wholesale stores, and 24 small corner stores and their customers, and     assess program implementation through detailed process evaluation, and (3) to assess impact     of multilevel health communications and pricing strategies, combined and separately, on     consumer dietary patterns and food source use, food purchasing behaviors, psychosocial     variables, food security, and individual weight and height.   "
76856|NCT02279836|"     The objective of the study is to gather post-market data regarding the performance of the     invendo SC20 colonoscope in a real-world US population.   "
76857|NCT02279823|"     In this proof-of-concept study, the safety and efficacy of a solution formulation will be     investigated in male subjects with androgenetic alopecia (AGA) after twice daily application     for up to 26 weeks.   "
76858|NCT02279810|"     The study evaluates the knowledge, attitude and practice about organ transplantation among     medical students and medical staff.   "
76859|NCT02279797|"     The study evaluates the knowledge, attitude and practice about bone marrow donation among     medical students and medical staff.   "
76860|NCT02279784|"     The aim of this study is to compare in patients with critical limb ischemia the efficacy of     angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in     terms of restenosis.   "
76889|NCT02279407|"     This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study     performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and     dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as     measured with magnetic resonance imaging (MRI))   "
76890|NCT02279394|"     This research study is aimed to determine the proportion of high risk smoldering multiple     myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide     and dexamethasone combination therapy.   "
76861|NCT02279771|"     Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is     a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer     recurrence and eventually death. In order to prevent this complication a protecting diverting     stoma is usually fashioned with consequent morbidity due to the stoma and its closure and     severe impact on patients' quality of life. This prospective, multi-center, parallel-arm,     randomized controlled equivalence trial is aimed to demonstrate whether a transanal     reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer     surgery thus avoiding the need for a covering ileostomy   "
76862|NCT02279758|"     Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence.     The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has     demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in     preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may     be an alternative treatment for this disease.      Eligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine     tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg     every 12 hours, and each cycle will consist of 30 days. After 180 days of treatment the     efficacy of metformin under the control of disease progression will be evaluated. As a     secondary outcome the investigator will check the patient adherence to the treatment, the     control of patient symptoms with functioning neuroendocrine tumor, and disease free survival.     Also will be performed an analysis of immunohistochemical expression of mTOR pathway proteins     of these patients.   "
76863|NCT02279745|"     This study is an open-label extension study to determine the long-term safety and     tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2 study,     APD811-003. Patients must have completed the APD811-003 study and must meet eligibility     criteria for APD811-007.   "
76864|NCT02279732|"     The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin     will extend the life of patients with squamous only non small cell lung cancer more than     placebo plus Paclitaxel and Carboplatin.   "
76865|NCT02279719|"     This is an open label, three-arm, phase 1 dose escalation study and phase 2 study of BBI608     in combination with sorafenib, or BBI503 in combination with sorafenib. The study population     is adult patients with advanced hepatocellular carcinoma who have not received systemic     chemotherapy.   "
76866|NCT02279706|"     Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).   "
76867|NCT02279693|"     This study evaluates the dose received by the prostate with in vivo dosimetry when delivering     image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy     (IMRT) for patients with localized prostate cancer using two repositioning techniques:     fiduciary markers or soft tissues.   "
76868|NCT02279680|"     The objective of this multidisciplinary project is to explore the deficit of associative     memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain     connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has     been evocated but has never been tested. Hence, the present project will include two     complementary assessments conducted on a group of adults aged from 18 to 30 with ASD compared     to a control group matched in chronological age and intellectual quotient. The first     assessment is devoted to the study of associative memory and its EEG correlates and the     second focused on the investigation of perceptual strategies related to associative memory     using the technique of Eye-tracking. Both behavioral and imaging data would provide new     insights on the relationship between perception and memory in ASD.   "
76869|NCT02279667|"     Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9     males and 9 females). The study consisted of three consecutive single-dose treatment periods     separated by a washout period of 7 days or more. On each treatment period, the volunteers     received a single dose of BIA 2-093 800 mg, orally.   "
76870|NCT02279654|"     This registry is a prospective, non-interventional, post authorisation safety study for     patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk     Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5     [del(5q)].      The purpose of this study is to collect additional data about the safety of an oral drug     (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the     need of blood transfusions. However, also patients affected by the MDS del(5q) who receive     other treatments different from lenalidomide can be included in this study, if they agree.   "
76871|NCT02279641|"     This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male     subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics     (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.   "
76872|NCT02279628|"     The cesarean section is considered as a painful surgery during the post operative period.     Mothers may need to move immediately after the surgery to take care of their babies. This may     increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is     required so that mothers do not experience pain in caring for their baby. Currently, several     techniques have been developed to manage postoperative pain related to c-section scar such as     intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound     infiltration. The comparison between anesthetic techniques has never been performed and it is     still not know if the combination of intrathecal morphine plus continuous pre-peritoneal     wound infiltration provide a synergistic or additional effect on pain relief.   "
76873|NCT02279615|"     The purpose of this study is to investigate the safety and efficacy of combination therapy     involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB     symptoms in male patients with BPH.   "
76874|NCT02279602|"     Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom     response are eligible to enroll in this rollover study to continue once every three weeks     fosbretabulin infusions for up to one year.   "
76915|NCT02279069|"     Stroke patients frequently necessitate walking aids such as 4-point canne. However, the     4-point canne has to be lifted by the patient which limited gait speed. The adjunction of     small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to     walk without having to lift the canne as it will roll over the ground.      The aim of our study is to compare gait parameters (gait speed and energy cost) with a     classical 4-point canne and with 4-roll canne.   "
76875|NCT02279589|"     Immune response analysis after the combination of PCV13 and PPV23 will lead to evaluate if a     prime with PCV13 help to obtain a good response to repeated dose of PPV23.The     hyporesponsiveness following the unconjugated vaccine is associated with high polysaccharide     antigen concentration. Several issues limit the development and recommendation of     anti-pneumococcal vaccine in adult's patients at risk. Reduced doses of unconjugated     polysaccharide antigens would bypass the hyporesponsiveness and maintain the expanded     coverage serotype.      A better knowledge of immune response following the combination of two vaccines in adults is     essential. In addition, adults are required to be exposed to repeated doses of polysaccharide     antigens by vaccine or by natural exposure, it is important to determine the extend and     duration of any hyporesponsiveness.      The main objective is to evaluate if non conjugate polysaccharidique fractionated doses     administered after a conjugate vaccine help to avoid hyporesponse in a schedule with repeated     injections of pneumococcal polysaccharidique vaccine   "
76876|NCT02279576|"     Penile cancer is an uncommon disease, with devastating physical and psychological effects on     patients. Penile carcinoma even in advanced stages is responsive to several chemotherapeutic     agents. However, due to the low incidence of penile cancer, no large studies have been     reported concerning chemotherapy.      Various single agents were tested for activity en penile cancer in de 70s and 80s. Response     rates ranged from 10 to 27% with cisplatin, 20 to 21% with bleomycin, and 0-62% with     methotrexate. These agents in combination were tested in different studies. Other     chemotherapy schemes have been studied, as combination of cisplatin with 5 fluorouracil with     or without taxol, and cisplatin plus irinotecan. All of them in limited phase II studies,     with described higher responses rates in some of them but without results confirmation in     phase III studies.      In conclusion, tested regimens so far have not been very successful in advanced stages of the     disease.      Antiangiogenic therapy has been demonstrated effective in the treatment of similar cancer     types as lung and head and neck, so it can be postulated that antiangiogenic therapy can be     effective in the treatment of penile carcinoma. Pazopanib is a new potent oral antiangiogenic     therapy.      Cytotoxic agents, such as paclitaxel, when administered at low doses and frequent intervals,     may exert antiangiogenic effects, thereby enhancing anticancer activity. Recently,     combination of pazopanib and paclitaxel administered in a metronomic schedule (80mg/m2 weekly     3 weeks every 4 weeks cycle) obtained a 40% response rate and an 80% of disease control in     the first-line treatment of melanoma patients. Treatment was well tolerated.      As paclitaxel and antiangiogenic drugs seem a very active treatment, combination of pazopanib     and paclitaxel seems a good combination to be tested in patients with penile carcinoma.   "
76877|NCT02279563|"     This study is to evaluate the equivalence of generic Azelastine Hydrochloride and Fluticasone     Propionate Nasal Spray with that of the marketed drug, Dymista™ Nasal Spray, in the treatment     of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic     Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with Dymista™ nasal     spray.   "
76878|NCT02279550|"     The purpose of this study is to create an institutional and population-based registry of Hip     fracture in the elderly with a prospective survey based on epidemiological data, risk     factors, diagnosis, prognosis, treatment, monitoring and survival.   "
76879|NCT02279537|"     The purpose of this study is to collect real-life data on patients with wet age related     macular degeneration (AMD) for whom treatment with Eylea was initiated   "
76880|NCT02279524|"     This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed     to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years     of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a     period of 6 months before entering the study, with overweight or obesity and who are pre     diabetic or type II diabetic.      Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg     tablets and placebo tablets in ratio 2:2:1.      The subjects will be evaluated at study sites for 11 scheduled visits during one year (52     weeks). After completion of the study treatment period, the subjects will be followed for an     additional period of 13 weeks without study medication (until visit 11 (week 65)).   "
76881|NCT02279511|"     To Check whether systemic treatment with ATP alters the profile of cerebral metabolism in     patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy) and     adjust the infusion (minimum effective dose) that promotes this metabolic change.   "
76882|NCT02279498|"     Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes     including lipase, protease, and amylase. The purpose of the present study is to provide     additional efficacy and safety data compared to approved, porcine-derived, enterically-coated     and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the     study will be comparative efficacy measured as the change in the coefficient of fat     absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).      Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of     convenient formulations and with a number of foods without enteric coating.   "
76883|NCT02279485|"     This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll     a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence     between the oral suspension and tablet formulations of perampanel will be evaluated under     fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet     formulations will be evaluated under fed conditions. In both study arms, subjects will be     randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for     perampanel as either oral suspension or a tablet, and will then receive the alternative     treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a     washout of at least 6 weeks between the two treatment periods.   "
76884|NCT02279472|"     The purpose of this study is to analysis changes in anterior segment morphology after laser     peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment     effectiveness   "
76885|NCT02279459|"     The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate     changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas     (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the     added benefit of providing functional information that would only be possible with advanced     computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission     tomography (PET) imaging techniques.   "
76886|NCT02279446|"     Development of a validated computer-based instrument (software program) for the assessment of     intermediate visual acuity.   "
76887|NCT02279433|"     DS-6051b is an orally administered inhibitor of the tyrosine kinases ROS1 and NTRKs. This     phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects     and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the     pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.   "
76891|NCT02279381|"     Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of     the issue and well recognized interventions the investigators are proposing a randomized     controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a     neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and     application of chlorhexidine compared with standard neonatal care coupled with application of     chlorhexidine and essential neonatal care alone. The investigators anticipate that this study     will provide an evidence base way forward benefiting the children of Pakistan.   "
76892|NCT02279368|"     In Northern India, skewed sex ratios, female feticide and higher child mortality rates for     girls have become serious concern. The female child mortality as a result of son preference     have increased during the last several decades. Since families cannot know the sex of the     fetus due to Indian government policies, they now 'neglect' girl child to ensure there are     few survivors. Survival chances of second and third daughters are plunging neglecting     healthcare and nutrition has become tool for death as 'good riddance'.   "
76893|NCT02279355|"     The aim of this retrospective study is to overall evaluate and validate preoperative and     intra-operative risk factors for postoperative pressure ulcers in critically ill     postoperative patients.   "
76894|NCT02279342|"     The purpose of this study is to investigate the effects of febuxostat on coronary plaque     volume in patients with chronic stable angina and hyperuricemia.   "
76895|NCT02279329|"     Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive     pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history     will be imaged with CT and MRI for the development of tools to quantify and validate     longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.   "
76896|NCT02279316|"     Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The     study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home     strength exercise program (arm 2) against control (no exercise) on the rate of falling,     quality of life, gait performance and cognitive function. All groups receive vitamin D. In     addition the study shall test the feasibility of the recruitment and the interventions in     this target population.      The study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild     dementia. Participants are recruited by the memory clinic of City Hospital Waid.      During the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12     month). Despite major efforts the target population is very difficult to recruit and     adherence to treatment is low. We therefore decided to stop recruitment and to use this trial     as a pilot trial for future clinical trials of the same topic.   "
76897|NCT02279303|"     This randomized controlled trial will test the impact of a patient-navigated,     anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI]     and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast     cancer survivors compared to a control group.   "
76898|NCT02279290|"     This randomized controlled trial uses a modularized cognitive behavioral resilience training     (MCBRT) intervention to probe risk and resilience mechanisms linked to post-trauma     psychopathology. Ninety participants with a history of interpersonal trauma during childhood     or adolescence and mild to moderate distress will be randomized to MCBRT or a health     education control condition. The primary aims of this proposal are to examine whether     individuals who receive MCBRT demonstrate increases in psychological resilience, biological     resilience, and extinction learning compared to those in the control group. This study will     also explore associations between these psychobiobehavioral risk and resilience factors.   "
76899|NCT02279277|"     In this study, the investigators are investigating the effects of physical therapy (PT) for     treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee     replacement. Through the examination of patient outcomes, such as pain, stiffness, and     physical function, the investigators will determine if PT prior to total knee replacement is     an effective treatment in a patient with high grade OA.   "
76900|NCT02279264|"     Objectives:        1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings          from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor        2. To determine what percentage of time the RightSpot Infant pH Indicator could have been          used to determine the proper placement of the NG tube prior to feedings        3. To establish normative pH values for neonates   "
76901|NCT02279251|"     The study will evaluate two group CBT interventions delivered by school health nurses, in     cooperation with community psychologist and mental health care personnel, to adolescents with     mild to moderate levels of anxiety symptoms. The two interventions have different intensity     (5 versus 10 group meetings). The two group interventions se will be compared to a waitlist     control group.   "
76902|NCT02279238|"     In view of assessing the uphill walking capacity and to provide a functional stress test with     better sensitivity the investigators need a short term functional stress test over the gold     standard six minute walk test....      To demonstrate the significance of 3 minutes ramp walk test over 6 minutes walk test as a     functional stress test.      The investigators hypothesize that the investigators three minutes ramp walk test (3MRWT)     will be superior to the existing six minutes level walk test (6MWT) in the measurement of     functional capacity of post valve replacement patients.   "
76913|NCT02279095|"     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict     movement by locking joints leading to cumulative loss of function and disability. Mouse     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists     such as palovarotene to prevent HO following injury. This 24-month study will (1) continue to     follow the 40 FOP subjects who completed Clementia Study PVO-1A-201; (2) enroll up to 20     additional new subjects who have achieved at least 90% skeletal maturity; and (3) evaluate     the ability of different palovarotene dosing regimens to prevent HO in these subjects.   "
76914|NCT02279082|"     A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines   "
76903|NCT02279225|"     Temporomandibular joint dysfunction is described as a multifactorial disease and can be     directly linked to other diseases, being of structural factors of the Stomatognathic System     or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular     Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of     Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a     Randomized, Controlled and double-blind, with the intention to treat. In this way the sample     of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages     between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will     be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT)     group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy     Group (FT + A). Will be used as a means of analysis before and after interventions the     following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of     pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the     dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires     FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health     Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments     will total in 10 sessions held twice a week, and the FT and FT + groups to receive     Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered     39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic     activity in 75% of your MHR for 50 min and the P group will receive the application of     Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis     will be compared using the t test intra-group-Student, one-tail and paired and can be used     the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.   "
76904|NCT02279212|"     Previous research on intensive care unit (ICU) survivors shows that rehabilitation is     challenging, because of patients experiences of disease related problems both under and after     treatment. Approximately 20 % of patients die within hospital, up to 80% suffer from     hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other     symptoms and disability (Angus et al 2004; De Letter et al 2001; Ely et al 2001; Nelson et al     2006; Van den Berghe et al 2001; Van den Berghe et al 2003) . A recent study shows that 28%     of intensive care survivors have chronic pain that reduce their health related quality of     life (Boyle et al 2004).      The aim of this study is to perform a survey about prevalence of pain type, and which     consequences this causes when it comes to function and quality of life up to 12 months after     the ICU stay.        1. What type of pain has ICU survivors and how do pain change over time, related to          treatment/rehabilitation and the illness' development?        2. What is the relationship between different pain characteristic, quality of life,          anxiety, depression, fatigue, sleep and PTSD in these patients?        3. What is these patients largest obstacle for good QoL after discharge from hospital?   "
76905|NCT02279199|"     The purpose of this study is to find out if gross motor skills of children and young adults     with bleeding disorders are different from those without bleeding disorders. The     investigators will use the standardized motor test the Bruininks-Oseretsky Test of Motor     Proficiency, Second Edition (BOT-2 tm). The second purpose is to establish if history of     joint disease secondary to bleeding affects gross motor skills.        1. Participants and setting: Subjects will include up to 100 male youth and young adults,          ages 4 to 21, recruited from the patient population of the Hemophilia Treatment Center          at OHSU. A mailing that describes the study may be sent to all potential subjects who          receive care through the Hemophilia Treatment Center at OHSU. Data collection will occur          at either clinic visits or in the home. Information, including history of change in          joint structure and synovium, from existing bleeding disorder repositories at OHSU will          also be used.        2. Design and Procedures: Research will be done using a prospective, cross-sectional study          design to examine any relationship between a diagnosis of bleeding disorder and gross          motor development. The gross motor ability of children and young adults with bleeding          disorders who meet the inclusion criteria will be compared to sex-specific normative          data from a standardized motor test. Information about age, type of hemophilia, presence          of an inhibitor, type of management used, body composition, range of motion, and hand          strength will also be collected through direct measurement and chart review. The          information collected will be entered into a repository. A subject may choose to opt out          of the repository while still participating in the research study. In addition,          information from a current hemophilia repository will be compared to gross motor ability          scores to determine if joint disease is related to skill level in this group of people.        3. Proposed analyses: Two-tailed t tests and logistic regression will be used to determine          if there are any significant differences.   "
76906|NCT02279186|"     In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss     during and after elective LSCS will be investigated.   "
76907|NCT02279173|"     This is a phase 3b single arm, open label, multicenter study describing the percentage of     time pediatric subjects with ITP have a platelet response while receiving romiplostim,     defined as a platelet count ≥ 50 x 10^9/L and in the absence of ITP rescue medications in the     past 4 weeks.   "
76908|NCT02279160|"     The study will be conducted as a placebo-controlled, randomized, 22 week double-blind study     which will include a dose titration period. An additional transition period will occur for     those patients who elect to enroll into the open-label extension study, APD811-007.     Approximately 60 patients with PAH will be enrolled.   "
76909|NCT02279147|"     RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to     patients who have obstructive jaundice after operation.      PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation     complications in patients with obstructive jaundice .   "
76910|NCT02279134|"     This phase III trial is studying how well the combination of chemoradiation or radiation     works in resected locally advanced cancer of the esophagus or gastroesophageal junction.   "
76911|NCT02279121|"     The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution     vs standard saline solution for primary prevention of central venous catheter-associated     bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor   "
76912|NCT02279108|"     The sentinel node has a fundamental role in the management of early breast cancer.      Currently, the double detection of blue and radioisotope is recommended. A radioactive     material requires the presence of a nuclear medicine department and the approval of health     authorities. In many centers, this technique is not available. The use of blue is easier to     implement technique. However, allergic reactions and prolonged breast tattoo led many teams     to stop the practice.      So in common practice, many center use a single method. However, with a single detection, the     risk of false negatives and the identification failure rate increased to a significant extent     and the number of sentinel lymph node detected and removed is not enough.      Under these conditions, find another method of detection seems crucial. According to the     literature, the fluorescence method (ICG) is a technique that seems safe and reliable.      The investigators therefore propose a prospective, randomized study to investigate the     interest of fluorescence associated with the isotopic method.   "
76916|NCT02279056|"     Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive     airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment     may be complicated in patients with co-morbid insomnia. This project evaluates the effects of     a self-help book for insomnia in patients being treated with CPAP for OSA.   "
76920|NCT02279004|"     Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and     melanoma, and is currently used to identify patients for treatment with targeted kinase     inhibitors like erlotinib and vemurafenib. However, tumor genotyping can be slow and     cumbersome, and is limited by availability of tumor biopsy tissue for testing. The aim of     this study is to prospectively evaluate a blood-based genotyping tool that can quantify the     presence of oncogenic mutations (EGFR, KRAS, BRAF) in patients with lung cancer and melanoma.     This assay is being studied both as a diagnostic tool for classifying patient genotype, and a     serial measurement tool for quantification of response and progression on therapy.   "
76921|NCT02278991|"     Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated     Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as     LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal     artery.   "
76922|NCT02278978|"     BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type     urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have     failed platinum-based chemotherapy.   "
76924|NCT02278952|"     This is a non-interventional cohort study to assess a novel assay to detect excessive or     insufficient immunosuppression from the drug tacrolimus in lung transplant recipients. The     assay measures mean residual expression (MRE) of genes downstream of NFAT, a transcription     factor regulated by tacrolimus. The investigators will assess whether MRE levels identify     subjects at risk for rejection (insufficient immunosuppression) or infection (excessive     immunosuppression).   "
76925|NCT02278939|"     Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US. and have     one of the highest prevalences of obesity and type 2 diabetes mellitus compared to     non-Hispanic whites, African Americans and Hispanics. However, FA have been underrepresented     in health related research, particularly in diabetes prevention. This proposed pilot study is     the first clinical trial to assess preliminary estimates of the short-term effect of the     novel social networking diabetes prevention program lifestyle intervention for this high-risk     population.   "
76926|NCT02278926|"     Aim/hypothesis: Subcutaneous insulin absorption is one of the factors which strongly     influence blood sugar control in patients with diabetes mellitus on insulin therapy. In     response, a regular absorption is influenced by lipo-hypertrophy in subcutaneous tissue on     injection sites. So far lipo-hypertrophy diagnosis has only been clinical since there are no     imaging studies that have characterized precisely morphometry of lipo-hypertrophic tissue.     Methods: In two groups of 20 type 1 diabetes patients on insulin therapy, lipo-hypertrophy is     characterized and defined by clinical tapping or by ultrasound with multi frequency linear     probe (6-18 Mhz). Patients are therefore advised to avoid insulin injections on those areas     so defined. Patients are reevaluated 3 and 12 months later   "
76927|NCT02278913|"     Few randomized studies have focused on the optimal management of non-ICU patients with type 2     diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen     with analogs and human insulins in general medicine patients admitted to a University     Hospital in Asuncion, Paraguay.   "
76928|NCT02278900|"     Aims of study While various communication aids have been evaluated separately, no studies     have taken a coordinated approach combining aids with different goals to evaluate their     combined impact. In this study the investigators will use two communication aids; a QPL and     an audio recording of the consultation. QPLs includes question concerning treatment options,     but few studies involving QPLs have explored whether QPLs result in patients taking a more     active role in the consultation. To our knowledge there have not been studies which     objectively try to explore whether patients receiving QPLs participates in shared decision     making to a greater extent, except for one ongoing Italian trial of breast cancer patients.      To explore and describe how communication aids as a QPL and an audio recording of the     consultation improve the first doctor-patient consultation at the oncology outpatient clinic     by        1. Encouraging patients/caregivers to ask more questions, particularly about sensitive          topics such as prognosis (as an effect of QPL alone)        2. Increasing shared decision-making (as an effect of QPL alone)        3. Improving overall satisfaction with the consultation and information retrieved (as an          effect of both communication aids)        4. Affecting quality of life/anxiety/depression (as an effect of both communication aids)   "
76929|NCT02278887|"     In this randomized controlled phase III study the investigators will evaluate whether TIL     infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus     interleukin-2 can result in an improved progression free survival when randomly compared to     ipilimumab in 168 stage IV melanoma patients. A health technology assessment (HTA) will be     performed to evaluate the impact of the TIL treatment on patients and organizational     processes and cost-effectivity.   "
77027|NCT02277613|"     This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility     of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).   "
76930|NCT02278874|"     The objectives of the clinical study are to demonstrate the accuracy of our proprietary     algorithm method to determine the genetic health of the developing fetuses in a multiple     gestation pregnancy from a maternal blood sample. The long term goal of this study will be     the development of a method of minimally invasive prenatal diagnosis that has a higher     sensitivity and lower false positive rate in the intended population (e.g. multiple gestation     pregnancies) than other currently available screening tests.      This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated     with a risk of miscarriage.   "
76951|NCT02278601|"     Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more     than 50% of parturients continue to experience pain leading to suffering and increased     caregiver workload. Women who have increased pain tend to have lower successful patient bolus     demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional     labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour     pain often escalates and worsens as labour progresses requiring an individualized, variable,     flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform     spread of local anaesthetics with better pain relief, compared to fixed background infusions.   "
77653|NCT02269436|"     This is an open-label, follow-on phase 1 study to assess the long-term safety and     tolerability of continuous i.c.v administration of 4 μg sNN0029/day in patients with ALS who     previously participated in study sNN0029-003   "
76931|NCT02278861|"     Actinic keratosis (AKs) are premalignant disorders that can evolve into skin cancer. To     prevent their development, a study is being conducted with oral isotretinoin and topical     tretinoin to verify what drug is the most effective and has the best security profile for     these patients. Along with these treatments, cryotherapy with liquid nitrogen and sunscreens     will be part of the treatment. The study will have the duration of 10 months. In the first     four months, the AKs will be counted and treated with cryotherapy (face and arms) and     sunscreens FPS 60 will be used. After it, the patients will return (the AKs will be counted),     a new session of cryotherapy will be performed and they will be randomized into two groups:     one group using oral isotretinoin 10mg/day ( ISO: 30 patients) and the other one using     tretinoin 0,05% cream (AR: 30 patients) applied on face and arms. Skin biopsies will be done     for all 60 patients at the beginning of the treatment with retinoids (isotretinoin and     tretinoin). After six months of treatment with retinoids, the study will be stopped, AKs will     be counted again and skin biopsies will be done. Patients in the group ISO (oral     isotretinoin) also have to make blood tests at the beginning, two months and after six months     of the treatment. Clinical (AK counting), histological (improvement of parts of the skin) and     immunohistochemical parameters will be evaluated to see what drug is more effective for     prevention of AKs.   "
76932|NCT02278848|"     Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled     cavities in the brain. The clinical symptoms are gait disturbance, mental decline and     incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be     able to induce regression of the symptoms in many cases meaning that ICAH is a classic,     curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting     cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is     complicated: improvement is often incomplete and there is no consensus on either how to     assess the symptoms or how they change after CSF depletion. In consequence, the decision     whether not to undertake surgery often depends on the neurosurgeon's clinical impression.      Over recent years, the cognitive profile of patients with ICAH has become better     characterised and reproducible, objective techniques have been developed to assess motor     function and CSF flow in the brain.      The investigators project aims to define the value of these new investigative techniques in     the positive diagnosis of ICAH, in comparison to current decision-making tools.   "
76933|NCT02278835|"     This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques     to prevent pulmonary collapse based in an score applied in the patients submitted of the     mitral valve surgery, after their ICU discharge.      Patients were allocated in groups according their pulmonary function (FVC: forced vital     capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP:     maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation;     respiratory frequency (f); the ability to expectorate and the functional independence.      The group I was allocated those patients which presented decrease of up to 50% of forced     vital capacity (FVC) of preoperative period, SpO2>92%, minimal pulmonary auscultation     alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance;     independence to sit; respiratory. In these patients were randomized for two interventions: a)     Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration     exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive     spirometer: used Coach® three sets of 10 repetitions.      Patients allocated in the group II presented FVC> 30% <49% of preoperative period, ≥ 88% SpO2     <92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f> 25 <31ipm; dependence     to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure     Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring     load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95%     with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in     the morning and another in the afternoon.      All of the patients were conducted in effort to mobilize upper and lower limbs. On the first     day, the patients walked at least 50 meters, by increasing the distance to at least 150     meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.   "
76934|NCT02278822|"     This trial is designed to provide evidence of the efficacy of liposomal glutathione     supplementation on healthy adults. The investigators anticipate that liposomal glutathione     supplementation will enhance the levels of blood glutathione and improve the immune     functions.   "
76935|NCT02278809|"     1. Development of a method for parents of primary schoolchildren to teach parents parenting          skills to obtain health gain in the family through videos and online feedback.        2. Effect- and procesevaluation of this methodology.        3. Development of an implementation guide together with VIGEZ as primary partner and in          association with partner organisations on the field.   "
76936|NCT02278796|"     In the treatment of patient with lymphoma the most common high-dose chemotherapy regimen used     prior to autologous transplantation (ASCT) is the BEAM regimen. It consists of four     chemotherapy drugs together (BCNU, etoposide, cyclophosphamide, melphalan), whose initial     letters are grouped together for BEAM regimen. One of the most common organ damage this     intensive treatment is caused by the drug BCNU; it involves a lung injury, which manifests     itself in the months after ASCT with increasing shortness of breath and cough, and can result     in pulmonary fibrosis. The drug bendamustine is used successfully in different lymphoma     types, and its efficacy in lymphoma therapy is well documented. Moreover bendamustine doesn't     cause lung injury. Initially experience with bendamustine instead of BCNU - in the so-called     BeEAM scheme - shows that this scheme is quite effective and well tolerated, without lung     injury. In BeEAM scheme therefore bendamustine replace the BCNU, while the other three drugs     are administered in the same dosage and order. The aim of the present study conducted at four     centers (Bern and Zurich in Switzerland, Vienna and Salzburg in Austria) is to compare these     two high-dose chemotherapy schemas and to show that the BeEAM scheme causes significantly     less lung injury than the BEAM regimen.   "
76937|NCT02278783|"     This will be a non-blinded, single arm study to test the efficacy of Regorafenib in patients     with recurrent ovarian, primary peritoneal, and fallopian tube cancer.   "
76938|NCT02278770|"     In this study, our novel MRI techniques for studying the small bowel will be applied to     patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be     determined using MRI measurements. These data will be correlated with measurements of     adipokines to determine if visceral fat has a specific influence on the severity of     diverticular disease.   "
76952|NCT02278588|"     In this investigator-initiated study, we will compare changes in brain cognitive biomarkers     assessed by diffusion tensor imaging over 2.5 years among 12 patients with Idiopathic     Parkinson's disease (IPD) receiving rasagiline, 20 IPD patients not receiving MAO-B     inhibitors and 25 age-matched healthy controls. Will also compare the changes in Mini-Mental     State Exam (MMSE) and Montreal Cognitive Assessment (MoCA) scores and plasma brain-derived     neurotrophic factor (BDNF) with changes in brain cognitive biomarkers in all IPD patients and     HC over 2.5 years.   "
76939|NCT02278757|"     Randomised clinical trial with a 6-month follow-up in Mexican adult men and women (20-65     years) with Metabolic Syndrome (MS). The sample size was calculated using a formula that     compares two means, an alpha of 0.05 and a power of 95%. Based on these calculations, we     established a baseline sample of 118 adults. For the diagnosis of MS, we used the     classification from the International Diabetes Federation (IDF). 150 patients were screened;     however, 32 were excluded because they did not meet the criteria. Doctors wrote down medical     history; nutritionists conducted anthropometry (weight, height, and waist circumference); and     nurses measured blood pressure and withdrew venous blood for determination of glucose,     triglycerides, and HDL-cholesterol. After being randomly assigned to one of two groups, the     control group received a diet with a lower protein content (0.8gr/kg body weight), and the     intervention group received a diet with higher protein content (1.34gr/kg body weight). Both     diets had equal amount of calories, were equivalent in the type of carbohydrate, and had a     caloric restriction of 500 calories less.      For the intervention group, meal replacements were made with soy protein, and individualized     menus, controlling the content of calories, protein, carbohydrates, and fat, had more control     over the total amount of protein consumed daily. Used as a substitute for food, the     protein-enriched drinks were prepared with 250ml of either milk with 1.5% fat or just water.     For both groups, the calorie density of the diet was adjusted for the baseline metabolic rate     of each participant with a restriction of 500kcal/day.   "
76940|NCT02278744|"     This is a phase I clinical trial investigating the use of single fraction re-irradiation     following local progression of spine and cauda equina (L2 to sacrum) lesions that have     previously received radiation therapy. Patients will be treated with single-fraction     radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.   "
76941|NCT02278731|"     To determine and compare the effects of a training program with Pilates and Facilitation     Neuromuscular Proprioceptive on balance and function in elderly women.   "
76942|NCT02278718|"     This study will be a two-arms study intending to demonstrate superiority of NexoBrid     treatment over SOC in children with thermal burns. The study objective is to evaluate the     safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep     partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard     of care (SOC).   "
76943|NCT02278705|"     The purpose of this study is to identify whether specific clinical practices—including,     body-mass-index (BMI) screening, identifying weight-related conditions (such as high blood     pressure), and scheduling follow-up visits to reassess progress—will improve the weight     status of overweight school-age children at one-year follow-up.   "
76944|NCT02278692|"     Calcific uremic arteriolopathy a.k.a. calciphylaxis is a vascular calcification disorder seen     in dialysis patients. Calcific uremic arteriolopathy has 60-80% one-year mortality and     significant morbidity associated with non-healing and extremely painful skin lesions. At     present, there is no effective treatment for calcific uremic arteriolopathy.      Vitamin K is an important vitamin for inhibiting vascular calcification. It is known to     increase the circulating levels of carboxylated Matrix Gla Protein, a potent inhibitor of     vascular calcification. However, the effects of vitamin K supplementation in patients with     calcific uremic arteriolopathy are unknown.      The purpose of this study is to conduct a pilot randomized controlled trial to examine the     effects of oral vitamin K supplementation on circulating levels of anti-calcification factor     (carboxylated Matrix Gla Protein) and clinical outcomes in patients with calcific uremic     arteriolopathy.   "
76945|NCT02278679|"     A digital rectal exam proficiency tool, titled the 'DiRECT' was developed based on the     consensus of 10 experts. The purpose of this study is to validate this tool for use in both     undergraduate and graduate medical education .   "
76946|NCT02278666|"     The aim of the present study is to assess in a real life case list the outcome of three     different surgical approaches for isolated aortic valve surgery in terms of surgery times,     morbidity and mortality.   "
76947|NCT02278653|"     The primary objective is to describe the functional outcome of patients that choose for organ     saving treatment.   "
76948|NCT02278640|"     This is a prospective, non-randomized, single arm, multicenter, study to assess the initial     clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total     laparoscopic hysterectomy. The study will not modify or influence current surgeon technique.     Investigators will perform each procedure using the device in compliance with their standard     surgical approach and product labeling.      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in     accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,     calibrated, and/or used in accordance with manufacturer design specifications, product     instructions and guidelines   "
76949|NCT02278627|"     During fthe first postoperative days, physiotherapists supported patients with knee     replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes     movements of the leg in active and non active motions, without any help and with an     arthromotor, and involves walking rehabilitation.      The investigators would like to complete the physiotherapist's support with manual lymphatic     drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might     have a positive impact on time recovery of joint range, on postoperative oedema resorbtion     and on patient's pain during rehabilitation classes.      French National Authority for Health specifies there is not a single study assessing massage     effects on knee replacement, according to current bibliography.      The investigators purpose is the establishment of a prospective, controlled, randomised trial     referred as a superiority trial. A total of 98 patients divided in 2 parallel groups will     be created.      The study will be in an open-label manner for both patient and physiotherapist involved in     walk rehabilitation but will be conducted as a blinded study for the investigating     physiotherapist.      Inclusion period will be 17 months and the following period will be 6 weeks.   "
76950|NCT02278614|"     The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005%     + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous     patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost     0.005% + Timolol 0.5% preserved eye drops).   "
77191|NCT02275468|"     a prospective, multicenter (outpatient clinics of the three participating hospitals in     Beijing), double blinded and randomized placebo-controlled study.      The study consisted of a 2-week run-in period and a 12-month treatment period.   "
76954|NCT02278562|"     By 2030 an estimated 2 million people in the US will need dialysis or transplantation for     advanced kidney failure. An even more disturbing statistic is that mortality in End Stage     Renal Disease (ESRD) is six times higher than in the general Medicare population with     adjustment for age, gender and ethnicity. Protein energy wasting is highly prevalent in these     patients and is one of the most important determinants of their poor clinical outcome.      Despite its well-recognized occurrence, the etiology and the mechanisms leading to protein     energy wasting observed in chronic hemodialysis patients cannot be attributed to any single     factor. However, irrespective of the specific etiologic mechanisms, it appears that the     common pathway for all the metabolic derangements is related to exaggerated protein     degradation relative to protein synthesis (47).      Two well-recognized and presumably interrelated metabolic abnormalities, insulin resistance     and chronic inflammation, may be the major determinants of protein catabolism in coronary     heart disease (CHD) patients. There are no studies examining the effects of anti-inflammatory     interventions and/or insulin sensitizers on protein homeostasis in CHD. Due to their     established anti-inflammatory and other pleiotropic effects, Interleukin-1 receptor     antagonist Anakinra and insulin sensitizer peroxisome proliferator-activated receptors (PPAR)     agonist Actos represent two such promising interventions. By modulating inflammatory response     and insulin signaling through two pharmacological interventions, the investigators will have     the unique opportunity to clarify mechanisms contributing of these two particular metabolic     derangements in the development of protein energy wasting observed in chronic hemodialysis     patients.      The overall goal is to elucidate the mechanisms by which chronic inflammation and insulin     resistance influence the development of protein energy wasting in hemodialysis patients.      Specific Aim: To test the hypothesis that inhibiting inflammatory response by administration     of an IL-1r antagonist (Anakinra) or increasing insulin sensitivity by administration of a     PPAR agonist (Actos) will improve net protein metabolism.      Hypothesis: The chronic inflammatory component of protein energy wasting (PEW) observed in     hemodialysis patients is, at least in part, mediated by insulin resistance.      Interim analysis may be performed (no specific plan at this time).   "
76955|NCT02278549|"     Low back pain (LBP) is a complex and common problem with major societal repercussions.     Clinical evaluations, and especially functional assessments, are necessary for proper     diagnosis and decisions on the most appropriate treatment. The assessment of lumbar     kinematics has been frequently described. For instance, measures of range of motion (ROM),     angular velocities and acceleration of the total lumbar spine (TLx) have demonstrated some     differences between healthy subjects and LBP patients. However, recent evidence has suggested     that models evaluating the TLx are insufficient. In fact, regional differences in kinematics     have been described between the upper lumbar spine and the lower lumbar spine.      The aim of this study is to evaluate the differences in spinal kinematics between healthy     subjects and LBP patients using a multi-segment model of the spine that allows regional     analysis.   "
76956|NCT02278536|"     The objectives of the clinical study are to demonstrate the accuracy of our new NATUS     diagnostic method to determine the genetic health of the developing fetuses in a multiple     gestation pregnancy from a maternal blood sample. The long term goal of this study will be     the development of a method of minimally invasive prenatal diagnosis that has a higher     sensitivity and lower false positive rate in the intended population (e.g. multiple gestation     pregnancies) than any currently available screening tests. This will result in fewer     unnecessary amniocenteses and CVS procedures, which are associated with a risk of     miscarriage.   "
76957|NCT02278523|"     Background：Respiratory muscle weakness is observed in chronic obstructive pulmonary     disease(COPD) patients and contributes to hypercapnia, dyspnoea, nocturnal oxygen     desaturation and reduced walking distance.During exercise it has been shown that diaphragm     work is increased in COPD and COPD patients use a larger proportion of the maximal     inspiratory pressure (MIP) than healthy subjects. This pattern of breathing is closely     related to the dyspnoea sensation during exercise and might potentially induce respiratory     muscle fatigue. Inspiratory muscle training(IMT) increases inspiratory muscle strength and     endurance, and decreases dyspnoea.But the mechanism of IMT still lack of research.      Purpose：The experiment is aim to compare of the similarities and differences of     transdiaphragmatic pressure by detecting the transdiaphragmatic pressure of COPD patients and     healthy volunteers in different intensity of threshold load conditions. Thus investigate how     inspiratory muscle training works or mechanism in lung rehabilitation programmes of COPD.And     emerging the theoretical basis of inspiratory muscle training from respiratory physiological     mechanism.   "
76958|NCT02278510|"     Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective     against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new,     investigational device that will be used to deliver topotecan directly into participants'     brain tumors. One purpose of this study is to determine whether the Cleveland Multiport     Catheter can be used effectively and safely to deliver topotecan directly into brain tumors.     This study will also evaluate different doses of topotecan that can be delivered to a     participant's brain tumor with use of the Cleveland Multiport Catheter, and it will also     examine how their tumor responds to treatment with topotecan.   "
76959|NCT02278497|"     The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of     coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera     and 99mcTc-mibi. 20 patients will have those measurements.   "
76960|NCT02278484|"     Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.   "
76961|NCT02278471|"     In this study the investigators will examine the effect of the polypill on medication     adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.   "
76962|NCT02278458|"     Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable     safety profile in subjects with locally advanced, unresectable or metastatic pancreatic     adenocarcinoma.The primary objective is to determine the safety profile of icotinib in     combination with gemcitabine in subjects with locally advanced, unresectable or metastatic     pancreatic adenocarcinoma.   "
76963|NCT02278445|"     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler     ultrasound system incorporating a special signal processing package- the Transthoracic     Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may     provide important insight into pulmonary blood vessels characteristics by the LDS (Lung     Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in     detecting PAH in SSc patients will be assessed in the study.   "
76991|NCT02278081|"     Gastroesophageal(GERD) reflux disease is a very common problem among pediatric population and     has be proved to contribute in numerous otolaryngological manifestations. Trails of empirical     treatment of antireflux medications is often used as a diagnostic test. However, the     investigators believe GERD can cause rhinitis and nasal obstruction. Nasonex is considered as     first line treatment for nasal obstruction. Hence, the proposed study aims to define the     relationship between GERD and rhinitis using randomize control trial where one group of     patients will receive nasonex and placebo, while the other group will receive nasonex and     antireflux medications.   "
76964|NCT02278432|"     Introduction. The prevalence of the use of drugs that act on the gastric system has increased     in the population. Omeprazole is an inhibitor of the protons pump and has a widespread use,     mainly as a prophylactic to prevent reflux esophagitis, gastric pathological hypersecretory     conditions, prevention of recurrence of gastric or duodenal ulcers, gastric mucosal     protection against damage caused by nonsteroidal anti-inflammatory drugs and during     Zollinger-Ellison syndrome. However, omeprazole is associated with several adverse events due     to abusive use or irrational prescribing, in disagreement with the indication, which may     cause the ineffectiveness of the drug and decreased patient safety. Objectives. To assess the     risk (occurrence of adverse events) and the benefit (effectiveness) of the prophylactic use     of omeprazole in hospitalized patients and to know the reasons for the prophylactic use     (indicated use or not approved). Patients and Methods. A observational and cross     pharmacoepidemiological study will be performed from June to November 2014, in the General     State tertiary referral Américo Brasiliense Hospital. Hospitalized patients will be separated     into three groups: those who make indicated and approved prophylactic use of omeprazole     (exposed group 1), those who make not indicated and not approved prophylactic use (exposed     group 2), and those who do not use the omeprazole (non-exposed group). Patients who do not     make prophylactic use of omeprazole will be excluded. Patients will have their     pharmacotherapy monitored and data will be collected daily using an investigation guide of     the first day of admission and will be included in group 1 or 2, from the first use of     omeprazole to discontinuation (washout period of seven half-lives or higher). National     Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) algorithm will     be used for causality analysis is used. Data will be tabulated according to the presence or     absence of effectiveness and the presence or absence adverse events in the three groups. The     odds ratio of adverse events and effectiveness of indicated and approve or not indicated and     not approved prophylactic use of omeprazole will be calculated. Expected results. It is     intended to know the odds ratio of adverse events in the prophylactic use of omeprazole with     or without indication or use approval, and the potential indications, dosage and unapproved     methods of prophylactic use in omeprazole label.   "
76965|NCT02278419|"     The purpose of this study is to evaluate the efficacy of simeprevir in combination with     sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of     participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in     the overall population.   "
76966|NCT02278406|"     The purpose of this study is to determine if deep brain stimulation can change brain oxygen     levels in people with Parkinson's Disease. Measurements will be taken using a non-invasive     device while subjects are both on and off their medications, and while their stimulator is in     the on and off setting.   "
76967|NCT02278393|"     Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy     product over a 4-week period in Japanese healthy adults   "
76968|NCT02278380|"     This study is initiated to investigate the glycemic index value of seven food products.   "
76969|NCT02278367|"     This study is designed to expand the database of 18F-AV-1451 safety and tau binding as     measured by PET imaging and to provide standardized conditions for 18F-AV-1451 use, data     collection and analysis to facilitate companion studies including, but not limited to,     longitudinal studies of aging, depression, and traumatic brain injury.   "
76970|NCT02278354|"     Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive     18F-AV-1451 to explore its use as a biomarker for brain injury related to repetitive head     trauma and to examine the relationship between clinical presentation and tau deposition.   "
76971|NCT02278341|"     This study is conducted to explore a new therapy for anemia in patients with end stage renal     disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin.     Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The     purpose of this study is to evaluate if roxadustat is effective and safe in the maintenance     treatment of anemia in ESRD patients on stable dialysis. Roxadustat will be compared to     epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.   "
76972|NCT02278328|"     This is a single-site, randomized, acute dose-response study to determine whether STX209     produces a dose-dependent significant change in MEG target parameters compared to baseline as     well as compared to placebo treatment.   "
76973|NCT02278315|"     The primary objective of the study is to determine the safety and tolerability of     I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed or     refractory multiple myeloma who have previously been treated with, or are intolerant of, an     immunomodulator and a proteasome inhibitor.   "
76974|NCT02278302|"     Study to investigate whether psychomotor performance which is necessary for safety driving a     car or operating machinery and safely participating in daily life is changed by Aggrenox®.     Also to investigate whether Aggrenox® impairs performance in combination with alcohol more     than alcohol alone. Derived from this: Statement on whether a warning for drivers is     necessary   "
76975|NCT02278289|"     The purpose of this study is to compare the efficacy of combining a wrist orthosis with     either ultrasound therapy or paraffin bath therapy in treating carpal tunnel syndrome     patients.   "
76976|NCT02278276|"     The purpose of this study is to determine the safety and benefits of SG1002, including     overcoming deficits in circulating hydrogen sulfide and nitrite found in heart failure     patients, with secondary endpoints focused on improving clinical endpoints.   "
76977|NCT02278263|"     Total knee joint replacement surgery can lead to significant blood loss, which can affect     recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of     blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of     debate. Growing interest in the topical application of TXA (directly into the surgical wound)     has been suggested as an alternative way of administering TXA, and may demonstrate similar     effectiveness as when it is given intravenously. Therefore, this multicentred, randomized     controlled trial, aims to investigate the safety and effectiveness of both topical and     intravenous administrations of TXA in total knee joint surgery. The investigators predict     that both routes of administration will demonstrate similar results when compared to placebo.   "
76978|NCT02278250|"     The purpose of this study is to evaluate the safety and tolerability of multiple ascending     doses of single-agent VX-803 administered twice-weekly (BIW) in subjects with advanced solid     tumors. This investigation is a three part study examining VX-803 alone and in combination     with carboplatin, gemcitabine, and cisplatin to determine the safety and maximum tolerated     dose.   "
76979|NCT02278237|"     Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million     hospitalizations in the United States annually1 and COPD is the third leading cause of 30-day     re-hospitalizations.2 Clinical trials have established the efficacy of treatments primarily     dispensed via respiratory inhaler devices that reduce morbidity and health care utilization     if they are used correctly.3-4 Unfortunately, the effectiveness of these medications in     real-world settings is limited by the fact that patients often do not use inhalers     correctly.5-6 Current guidelines recommend assessing and teaching inhaler technique at all     health care encounters, including hospitalization.77.5 My work has found that over 75% of     hospitalized patients in an urban, predominantly underserved population misuse their     respiratory inhalers, highlighting a missed opportunity to educate these patients with high     potential to benefit.8 Hospitalization, therefore, provides a potential 'teachable moment' to     correct this misuse.9 My preliminary data indicate that one strategy, in-person teach-to-goal     (TTG), is effective in teaching hospitalized patients proper inhaler technique and is more     effective than simple verbal instruction.10      While TTG is a promising method to improve care for patients who use inhalers, several     limitations prevent widespread adoption. First, TTG relies on in-person assessment and     education, as well as training and monitoring instructors to ensure fidelity, making it     time-consuming and costly. Also, because a single educational session does not ensure     long-term retention,11-12 post-discharge reinforcement may be needed, which may be     impractical with in-person TTG. One potential method to surmount TTG's limitations is use of     interactive video module education (VME), a method that has been used for health education in     other clinical contexts.13-14 Through iterative self-assessments and video-demonstrations on     a tablet computer, VME has the potential to be less costly, maintain fidelity, and be more     easily extended into the post-discharge setting than in-person TTG. However, certain     questions remain about VME. It is unclear whether VME will yield similar results when     compared to TTG, or whether urban, underserved patients will have the ability to, and be     willing to use, VME in the post-discharge setting. Therefore, before widespread     implementation of VME, it is critical to rigorously develop and test VME for inhaler     education in the hospital setting. Ultimately, it will also be important to understand     patients' ability and willingness to use post-discharge VME for educational reinforcement to     allow for this strategy to transition patients across care settings from hospital to home.     Through these funded projects, I will acquire critical data I need to develop R-01 studies     focused on improving self-management for patients with obstructive pulmonary disease across     care transitions.      We hypothesize that interactive VME will lead to non-inferior rates of ability to demonstrate     correct inhaler use compared to rates with TTG among hospitalized patients with Asthma or     COPD.      For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler     technique prior to implementing a larger RCT to test the comparative effectiveness of VME     versus TTG.   "
76992|NCT02278068|"     The purpose of this research study is to collect information about a new treatment for Type 2     Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System     which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well     controlled despite treatment with multiple medications. The medical device delivers low-level     radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves     that lead to the liver. Previous research has shown that disrupting these nerves may lead to     a lowering of blood sugar levels.   "
76980|NCT02278224|"     Group based cognitive behavioural therapy (CBT) is an effective treatment of depression,     however, one third of patients do not respond satisfactorily (McDermut, Miller, & Brown,     2001), and relapse rates around 30% have been reported from several studies (Butler, Chapman,     Forman, & Beck, 2006).      The present study compares group based CBT with rumination focused CBT for depression with     respect to outcome and relapse.      Rumination has been evidenced as a crucial vulnerability to depression (Smith & Alloy, 2009),     predicting the onset, severity and duration of future depression (Nolen-Hoeksema, 2000).     Depressed individuals show a negative bias in the perception of facial emotion, in the acute     phase as well as in remission (Bouhuys, Geerts, & Gordijn, 1999), and display difficulties in     disengaging from negative stimuli (Koster, De Raedt, Goeleven, Franck, & Crombez, 2005). In     addition the present study investigate rumination and perceptual attention bias as potential     key mechanisms underlying depression.      128 depressed patients will be recruited and randomised for group based CBT or group based     rumination focused CBT. Patients are assessed subsequently during treatment and at 6 month     follow-up regarding depression, rumination, worry, negative perceptual bias, attention     control. Results are expected at spring 2016.   "
76981|NCT02278211|"     This is a multi-centre observational study. It will make use of the positron emission     tomography (PET) tracer 18F-sodium fluoride (18F-NaF) as a marker of coronary plaque     vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with     recent myocardial infarctions. The investigators will then perform long-term follow-up of     these patients to determine the prognostic significance of coronary 18F-NaF uptake   "
76982|NCT02278198|"     The purpose of the study is to find out if the small dose of radioiodine, that is used for     the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer cells     and make the thyroid cancer treatment less effective.   "
76983|NCT02278185|"     This randomized phase II trial compares enzalutamide with standard androgen deprivation     therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has     spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol,     blood pressure, circulating sugar levels, and body weight. Previous studies have shown that     patients with prostate cancer, who have been treated with standard medical therapy that     lowers testosterone levels, have an increased risk of these changes. Hormone therapy using     enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells     instead of lowering testosterone levels. It is not yet known whether prostate cancer patients     who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who     receive standard androgen deprivation therapy.   "
76984|NCT02278172|"     The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max     in athletes.      Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle     function, lung function, body composition, immune function and the self-reported incidence of     upper respiratory tract infection.      This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to     recruit a total of 50 athletes randomised into either a placebo or treatment group for a     12-week intervention.   "
76985|NCT02278159|"     The purpose of this study is to evaluate which home dialysis modality pattern (home     hemodialysis [HHD], peritoneal dialysis [PD] or a combination of both, e.g. PD and then HHD)     allows for the longest home dialysis survival, as defined by the time dialysed in a home     environment. The investigators hypothesize that patients transferred from one home modality     to another will have a longer home dialysis survival compared to patients treated only with     PD or HHD.   "
76986|NCT02278146|"     A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System     for the treatment of urinary incontinence and overactive bladder.   "
76987|NCT02278133|"     The purpose of this study is to assess the safety and anti-tumor activity of the triple     combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or     RSPO fusions.      The design of this study is based upon the translational and pre-clinical data that suggest     that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with     the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these     signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor     activity.   "
76988|NCT02278120|"     This is a multi-center, randomized, double-blinded, placebo controlled trial in     pre-menopausal women with advanced breast cancer.   "
76989|NCT02278107|"     A preliminary study to evaluate a new nasal interface and portable ventilator system in     comparison to standard oxygen therapy in patients with severe chronic lung disease.   "
76990|NCT02278094|"     Background: OSAS is a type of sleep disorder characterized by intermittent, partial or     complete upper airway (UA) collapse, seriously impacting sleep apnea and respiratory     insufficiency. The major upper airway dilator muscle (genioglossus) is more active during     periods of stable breathing compared with periods of cyclical breathing when obstructive     apneas occurred. UA muscle strength is linearly related to the inspiratory pump muscle     strength. The ratios of UA muscle strength (tongue protrusion, TP) and inspiratory pump     muscle strength (PImax) were not different between individuals with and without OSAS.     However, a highly wakeful ratio of TP force to PImax appears to be associated with a reduced     propensity to moderate-to-severe OSAS. Up to 95% of OSAS cases are treated with continuous     positive airway pressure (CPAP), which is the most effective, commonly used, and low-risk     treatment method. However, patients using CPAP therapy could face ongoing difficulties. Aims:     To evaluate the effects of home-based exercise for patients with moderate to severe OSAS.     This study was a randomized clinical trial conducted at three different intervention     protocols as experimental groups. We will use cluster random sampling assign to each group.     CPAP treatment group will be the control group. Methods: Subject above 20 years old will be     diagnosed to moderate and severe OSAS. Subjects will be assign to walking exercise (WE),     Threshold Inspiratory Muscle Trainer (TIMT) and Tongue Muscle Trainer (TMT) treatment groups.     We will compare the Polysomnography (PSG) data, Epworth Sleepiness scale (ESS), World Health     Organization Quality of Life( WHOQOL) questionnaire is a shorter version of the original     instrument (WHOQOL-BREF), 6-minute walking test (6MWD), rate of perceived exertion scale     (RPE), flow-volume loop (FV-Loop), tongue and grasp muscle strength, anthropometric data and     daily note at baseline, 3 months (end-of-intervention) and 6 months (post intervention     follow-up) in patients with moderate to severe OSAS. They will undergo three months of the     home-based exercises. Patients will be followed up with weekly telephone calls and be     interviewed monthly. Expected results: By using the WE, TIMT and TMT therapies, the airway     collapse during sleep will be prevented when the whole body muscle strength, inspiratory pump     muscle strength and tongue muscle strength are enhanced.   "
76993|NCT02278055|"     The purpose of this study is to find out if Radium-223 is effective in reducing cancer pain     within 12 weeks of treatment. In order to see if Radium-223 is effective, the patient's level     of pain will be followed throughout the study.   "
76995|NCT02278029|"     This study will synthesize a behavioral profile of impaired driving performance for teenage     patients with mild traumatic brain injury (mTBI), or concussion, from one week     post-concussion to six weeks post-concussion. It will also elucidate the relation between     decreased reaction times exhibited by these patients and their functional response to driving     hazards. While a few studies have examined driving performance in adult patients with mTBI,     to the investigators knowledge this will be the first investigation of driving performance     for teenage patients with mTBI. Therefore, it will provide the foundation for the future     development of return-to-drive protocols for physicians and clinical practitioners. This     study will synthesize a behavioral profile of impaired driving performance for teenage     patients with mild traumatic brain injury (mTBI), or concussion, from one week     post-concussion to six weeks post-concussion. It will also elucidate the relation between     decreased reaction times exhibited by these patients and their functional response to driving     hazards. While a few studies have examined driving performance in adult patients with mTBI,     to the investigators knowledge this will be the first investigation of driving performance     for teenage patients with mTBI. Therefore, it will provide the foundation for the future     development of return-to-drive protocols for physicians and clinical practitioners.   "
76996|NCT02278016|"     Bacterial meningitis is a potentially life-threatening disease that is associated with     substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve     outcome and prevent antibiotic overuse. Here we try to explore new biological markers for the     diagnosis of the central nervous system infection disease.   "
76997|NCT02278003|"     The goal of this study is to extend findings of propofol's effects on memory, as measured in     volunteer research studies, to a clinical setting.   "
76999|NCT02277977|"     Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic     shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore     useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and     thus multiple organ failure or death. Clinically, the microcirculation can currently be     indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of     the present study is to measure the microcirculation in septic shock by means of     contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to     24 subjects during and after septic shock. It will be investigated in this study whether the     microcirculation measurement with ultrasound contrast reflects the severity of the disease.     As well as to evaluate whether the use of this diagnostic method could lead to better     treatment of the septic shock.   "
77000|NCT02277964|"     This is an observational study to develop new hypothesis regarding the dynamic and safety of     switching from natalizumab to fingolimod:        -  Comparison of disease activity (clinical and MRI) during the year after change of          therapy in comparison to the year before change        -  Dynamic of onset of disease activity after having stopped treatment with natalizumab        -  Change of immunological parameters during treatment change from natalizumab to          fingolimod in comparison to clinical and MRI measures   "
77001|NCT02277951|"     The aim of the study was to compare time and success rates of four intubation devices ( in a     cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin     model.      The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.   "
77002|NCT02277938|"     Several factors discourage the implementation of cancer screening to the population in     general, which would result in earlier diagnosis and an expected improved survival.     Concurrent in vivo and in vitro research has shown that drug acetylation activity is     increased in cancer. Amantadine may be of value in detecting the presence of cancer.     Accordingly, this study will examine how Amantadine is eliminated by the body in cancer     patients. This is an important step in validating a cancer detection method that can be     implemented economically for screening of large numbers of people.   "
81554|NCT02218489|"     The primary purpose of this study is to determine the efficacy and safety of KPI-121     ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of     inflammatory meibomian gland disease.   "
77003|NCT02277925|"     Primary Aim:      The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and     suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with     a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene,     Gore-Tex) versus delayed absorbable monofilament (2-0 polydioxanone, PDS) sutures through     1-year.      Secondary Aims:        1. To compare the 1-year composite success rate (leading edge of prolapse is at or above          the hymen and apex has descended less than 1/3 of the vaginal length, no subjective          feeling of bulge; and no retreatment for pelvic organ prolapse (POP) or vaginal mesh          exposure) of permanent versus delayed absorbable sutures for mesh graft attachment          during robotic total hysterectomy and sacrocolpopexy.        2. To compare postoperative symptoms of pelvic floor disorders, including urinary          incontinence, voiding dysfunction, pelvic organ prolapse, sexual dysfunction and quality          of life between the 2 groups at 1 year.        3. To evaluate adverse outcomes in each group, classified according to the Clavien-Dindo          system.   "
77004|NCT02277912|"     The aim of the study is to evaluate the analgesic effects of navigated repetitive     transcranial magnetic stimulation in central post stroke pain. MRI based navigation is used     to determine the exact locations for stimulation.   "
77005|NCT02277899|"     The purpose of this study is to determine communication content and strategies in primary     care that predict improvement in weight status among overweight school-age children.   "
77016|NCT02277756|"     Pain insensibility is often described in people with autism. The aim of this study is to test     the pain perception in adults with autistic spectrum disorder without intellectual     disability. An experimental model of pain is used to measure endogenous modulation systems.     Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test     excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system     (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus     G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation     assessed by an inspired behavior scale.   "
77017|NCT02277743|"     This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the     efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic     dermatitis (AD).   "
77006|NCT02277886|"     Among those patients experienced GERD symptoms, up to 89% report nocturnal symptoms,     resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication     indicated for the relief of gastroesophageal reflux symptoms. This multi-center, open-label,     randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed     time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive     GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include     percentage of patients with relief or complete resolution of nighttime heartburn (or     regurgitation), percentage of patients with relief or complete resolution of GERD-related     sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation)     over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI)     questionnaire total score, and change of the percentage of patients with relief of nighttime     heartburn (or regurgitation) at post-treatment visit as compared to final visit in test group     (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study hypothesis     is that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving     nighttime reflux symptoms and sleep disturbance in erosive GERD patients.   "
77007|NCT02277873|"     The purpose of this study is to establish the relationship between moon and births through     two analytic models.   "
77008|NCT02277860|"     Physical activity and exercise have become an accepted and valued component of cystic     fibrosis care. Regular physical activity and exercise can slow the rate of decline of     pulmonary function, improve physical fitness, and enhance quality of life. However,     motivating people to be more active is challenging. Supervised, facility-based exercise     programs are expensive and labor intensive (since groups of patients with CF cannot exercise     together in the same physical location). Home-based exercise using an interactive exergame     device may be an effective way to improve adherence to an exercise program for patients with     CF. Therefore, the primary objective of this study is to evaluate the effects of a 12-week,     home-based exergame exercise intervention on aerobic capacity (peak VO2). The secondary     endpoint is nasal potential difference, an indicator of how well sodium and chloride flow     across the mucous membranes in the nose. Other outcomes include patient-reported quality of     life and habitual physical activity level. Following baseline assessments participants will     be begin a 12 week, partially-supervised exercise program consisting of at least 90 minutes     per week of aerobic and resistance exercise training using the Nintendo Wii Fit Plus     exergaming device. Participants will receive at least monthly follow-up phone calls to     provide additional exercise counseling and motivation. After 12 weeks, they will continue     with the exergame intervention for another 12 weeks, but without external supervision.   "
77009|NCT02277847|"     Study Design: Treatment, Randomized, Open Label, Parallel Assignment This study is an open     randomized and controlled trial aiming at assessing the efficacy and safety of Idarubicin     (IDA) at different doses of 8mg/m2 and 10mg/m2 combined with cytarabine as induction therapy     for newly diagnosed Acute Myeloid Leukaemia (AML). All the recruited patients are allocated     to group A ( 8mg/m2 group) or group B ( 10mg/m2) in random. It is advised that induction     therapy should begain not late than 3 days after randomization. The regimens in detail can be     refered in the therapy protocol.   "
77010|NCT02277834|"     Currently, X-rays and blood tests often miss pancreatic cancer. In this study, we are     collecting and studying the fluid produced by the pancreas as a way to detect pancreatic     cancer at an earlier stage.   "
77011|NCT02277821|"     The action of one Stendo pulsating suit session will be evaluated on 24 patients referred to     the hypertension consultations for essential hypertension treated but not stabilized. The     effect of one Stendo pulsating suit session system will be mainly assessed on the peripheral     cutaneous microcirculation and on the central arterial pressure.   "
77012|NCT02277808|"     The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®,     disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have     comparable properties and better availability to the hospital. Several studies remark that     all nebulizers with comparable properties could be used for the nebulization.The aim of our     work will be to evaluate and compare the pulmonary deposition between the reference nebulizer     Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will     measure and compare these data's for each of the nebulizers via nebulization Amikacine and     urinary dosage.   "
77028|NCT02277600|"     This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male     and female subjects. There is no formal hypothesis, however, it is expected that the     coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase     the systemic exposure of BMS-626529.   "
77228|NCT02274987|"     This is a single arm multi-center pilot trial within the Pacific Pediatric Neuro-Oncology     Consortium (PNOC). The current study will use a new treatment approach based on each     patient's tumor genomic profiling consisting of whole exome sequencing and RNA sequencing as     well as predictive modeling.   "
77013|NCT02277795|"     Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention     strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces     men's risk of heterosexually-acquired HIV-1 infection by about 60%. Early infant male     circumcision (EIMC) confers the same benefits of MC in older ages for prevention of HIV and     other sexually transmitted infections, and is less expensive and safer. To provide the     evidence-based guidance for implementation of EIMC services, the investigators propose an     implementation study to address several salient operations-research questions. Members of the     research team have conducted a pilot study of the promising, but relatively new AccuCirc     device for EIMC in Botswana and found it to be very safe. The AccuCirc device has the     potential to simplify supply chain management in addition to eliminating the rare but serious     potential complications associated with other EIMC devices. The investigators propose to     enroll 600 infants in a safety and feasibility study of the AccuCirc device. Furthermore, it     is imperative to identify, understand and overcome barriers to the adoption and integration     of EIMC from the perspective of providers, about which virtually nothing is known. The     investigators will explore, through qualitative methods, the perspective of providers with     regard to offering and providing EIMC services. Equally important is having a thorough     understanding of decision-making among parents with regard to opting for EIMC. The research     team proposes to study this through collection of qualitative data among fathers and mothers.     Lastly, the investigators will gather observational survey data from mothers in the catchment     area and data from mothers who opted for EIMC will be compared with those from mothers who     did not opt for EIMC to identify factors associated with uptake, including if, when, where     and by whom EIMC services were offered. Among providers and parents the researchers will     specifically explore what role, if any, the EIMC device plays in decision-making. The     findings from this study will provide evidence necessary to refine implementation strategies     for EIMC into public health and clinical practice settings and to assist the Kenyan Ministry     of Health, other African governments and PEPFAR in the scale-up of EIMC service delivery for     long-term HIV prevention.   "
77020|NCT02277704|"     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose,     parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL     —a sublingual formulation of cyclobenzaprine. Following successful screening and     randomization, eligible subjects will return regularly to the study clinic for weekly or     biweekly visits for assessments of efficacy and safety.   "
77021|NCT02277691|"     The purpose of this study is to evaluate the safety of long-term administration of TAK-536,     amlodipine (AML), and hydrochlorothiazide (HCTZ) in participants with essential hypertension.   "
77022|NCT02277678|"     The primary objectives of this study are to compare the efficacy of pain relief between     epidural oxycodone and epidural morphine for postoperative analgesia after elective caesarean     section and to compare the incidence and severity of pruritus. Secondary objectives are to     compare other side effects of epidural administered oxycodone and morphine (nausea and     vomiting, sedation, respiratory depression) and to investigate the safety and efficacy of     epidural oxycodone and epidural morphine after use for postoperative analgesia in caesarean     sections.   "
77023|NCT02277665|"     Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly     smoke tobacco. Combining tobacco with cannabis has become a common method of smoking     cannabis. Similarities of use, and using together, can make quitting difficult. Stopping     tobacco simultaneously with cannabis may be beneficial. Little scientific information     currently addresses how to best target tobacco smoking during treatment for CUDs. Our     long-term goal is to develop an effective protocol for intervening in tobacco smoking without     changing cannabis outcomes.      This protocol reflects the planned Stage 1, proof-of-concept study that will compare a     combined cannabis and tobacco intervention to one that targets CUD only. Hypotheses assert     that the intervention (1) will be accepted by the majority of eligible participants (2) will     result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not     adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific     moderators of outcomes to predict outcomes and inform subsequent treatment development     efforts. If the hypotheses were confirmed, dissemination of this protocol would reduce     adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will     inform future development of prevention and intervention strategies.   "
77024|NCT02277652|"     The purpose of this study was to compare the four different intubation devices in 6 different     scenarios.   "
77025|NCT02277639|"     This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen     to allow successful engraftment with CD3+ /CD19+ depleted peripheral stem cell grafts from     mismatched donors. There are two conditioning regimens depending upon patient diagnosis and     age.   "
77026|NCT02277626|"     It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum     weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway     clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health     and perform AC at home as part of their routine therapeutic regimen.   "
77029|NCT02277587|"     This is a randomized, controlled, open, three-armed, multi-centre study designed to compare     the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid     therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile,     cardiovascular system, bone mass and quality of life in patients affected by primary or     secondary adrenal insufficiency.   "
77030|NCT02277574|"     This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center     study of AMP-110 in adult subjects with rheumatoid arthritis.   "
77031|NCT02277561|"     This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting     response in patients with brain metastases undergoing whole-brain radiation therapy or     stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to     measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than     is possible with a standard magnetic resonance imaging. The earlier ability to measure     response may allow for consideration of alternative therapies at an earlier stage.   "
77032|NCT02277548|"     To assess the efficacy of pregabalin in the management of mucositis pain in patients     receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among     those being treated for oropharyngeal cancer with definitive chemotherapy and radiation     therapy (photons) to the head and neck in the Department of Radiation Oncology at the     University of Pennsylvania.   "
77033|NCT02277535|"     This is a quality improvement research project evaluating if a targeted feedback email to     clinicians impacts their nutrition delivery in the ICU.   "
77034|NCT02277522|"     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously     administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen     receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as     RNA CART19) in Hodgkin Lymphoma (HL) patients.   "
77035|NCT02277509|"     This study is being conducted in two phases. The first phase was a pilot implementation of     the study protocol, which provided preliminary data from seeking funding for a larger scale     trial. The study focused on testing the effects of a Diabetes Prevention Program (DPP) that     has been adapted culturally and linguistically to address diabetes prevention among Chinese     immigrants. Study implementation involves a variety capacity building community partnership     initiatives. Partnering organizations within New York City (NYC) have included the Chinese     Community Partnership for Health (CCPH) of New York Presbyterian Hospital of Lower Manhattan     Hospital, the Chinese American Independent Practice Association (CAIPA), the Diabetes     Research and Training Center of Albert Einstein College of Medicine (Einstein), and the City     University of New York (CUNY) School of Public Health. More recently, our collaboration has     expanded the potential for wider dissemination in collaboration with the Pace University     Confucius Center of the Confucius Institute. By supporting Chinese language and cultural     programs, the Confucius Institute facilitates communication with the 2 billion native Chinese     speakers as migration and trade increase interactions globally.   "
77460|NCT02271958|"     The purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg     doses of mifepristone against a placebo in women with laparoscopic diagnostic of     endometriosis.      The hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and     should be used in future studies on medical treatment of endometriosis.   "
77036|NCT02277496|"     The project is designed to evaluate a participatory implementation model in HealthCorps (HC)     high schools and to assess outcomes within and across school settings . The behavioral     objectives from the 2010 Dietary Guidelines to address obesity in youth include: 1)     decreasing sugary beverage intake; 2) increasing frequency of breakfast; 3) increasing     vegetable and fruit intake to 2½ cups per day;4) decreasing frequency of fast food meals;5)     becoming physically active (goal of 1 hour per day); and 6) reducing sedentary behavior time     (<2 hour day). The study is employing system dynamics modeling (SDM) to assess wellness     programming options and to evaluate the program implementation within the context of diverse     school ecologies. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption,     Implementation, and Maintenance) is used to guide SDM development and validation.      The Specific Aims are:        1. To use PAR (Participatory Action Research) methods to refine the school wellness program          model and toolkit components that address institutional/community level program          implementation barriers and individual level barriers to achieving healthy lifestyle          recommendations.        2. To assess the effectiveness of program components using process evaluation techniques          guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)          model.        3. To evaluate implementation with system dynamics modeling to facilitate dissemination.          The simulation analysis will apply the RE-AIM framework to address: Reach (participation          rates), effectiveness (outcomes), adoption (acceptability), implementation (intervention          fidelity), and maintenance (sustainability of lifestyle changes by students and programs          by schools), in order to facilitate refining the toolkits and training program for          dissemination to other school setting and diverse educational venues.   "
77037|NCT02277483|"     Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to     standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM)     induced allergic rhino-conjunctivitis with/without asthma.   "
77038|NCT02277470|"     The purpose of this study is to gain insights in the pharmacokinetics of golimumab in     moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and     maintenance treatment the investigators will collect blood and stool samples at different     time points.   "
77039|NCT02277457|"     Hypotheses:      Short-term - Targeted therapy with erlotinib or crizotinib plus PART (Personalized Adaptive     Radiation Therapy) will be safe and will yield favorable outcomes in patients with stage III,     EGFR (Epidermal Growth Factor Receptor) + or ALK (Anaplastic Lymphoma Kinase) + NSCLC     (Non-Small Cell Lung Cancer).      Long-term - In patients with stage III NSCLC harboring driver mutations, treatment with     relevant targeted agents plus PART will improve both local-regional and systemic tumor     control resulting in improved survival relative to standard chemoradiotherapy.   "
77040|NCT02277444|"     The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug     enters and leaves the blood and tissues over time) of golimumab administered intravenously     (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an     onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested     by greater than or equal to (>=) 5 joints with active arthritis despite methotrexate (MTX)     therapy for >= 2 months.   "
77041|NCT02277431|"     Participants experiencing recurrent gastrointestinal symptoms in this double-blind,     randomized, controlled trial will receive either a commercially-available probiotic dietary     supplement or placebo. The investigators hypothesize that participants in the probiotic     dietary supplement group will experience greater improvement in their gastrointestinal     symptoms than participants in the placebo group.   "
77042|NCT02277418|"     The purpose of this study was to compare the Venner a.p. advance video laryngoscope to Miller     laryngoscope during resuscitation with and without chest compressions.   "
77043|NCT02277405|"     The aim of the study was to compare time and success rates of four intubation devices in a     cardiopulmonary scenario with and without chest compressions with a standardized pediatric     manikin model.   "
77044|NCT02277392|"     This is a phase-I, dose escalation study to assess the safety and biological activity of     cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of vaccine-primed,     ex vivo CD3/CD28-costimulated peripheral blood autologous T-cells, and recombinant human     interleukin-18 (SB-485232, IL-18) treatment in adult patients with recurrent, Stage III or IV     ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent     induction vaccination with whole tumor vaccine   "
77045|NCT02277379|"     Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent     problem. Antiplatelet therapy (APT) is an integral component of perioperative management in     patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early     postoperative bleeding extent and transfusion requirements remains difficult to predict.      In addition to, resistance to antiplatelet drugs as well as perioperative increase in     platelet reactivity following CPB has been reported but this phenomenon has to be     comprehensively investigated.      The best point-of-care platelet function test to predict bleeding complications/transfusion     requirements remains unclear. In addition to, the best test platelet function test to monitor     resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.      The aim of this study is:        1. to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet)          in regard to prediction of bleeding complications/trasfusion requirements.        2. to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet)          in regard to detection of high on-treatment platelet reactivity both pre- and          postoperatively.   "
77046|NCT02277366|"     The purpose of this study is to determine the diagnostic yield of early lung cancer in high     risk population, who smokes or has other risk factors, by different bronchoscopy,.     Furthermore, another purpose is to determine whether the different bronchoscopy are     significant different in diagnosing early lung cancer.   "
77047|NCT02277353|"     NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices     derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the     previous studies. However, its usefulness in prone positioning has not been investigated.     Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke     volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients     undergoing spine surgery.   "
77048|NCT02277340|"     This study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic     cleaning and fulguration of pilonidal sinus inner surfaca followed by application of     crystallized phenol into the sinus.   "
77049|NCT02277327|"     The investigators hypothesize that an intervention, within an established patient-centered     medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital     utilization among medically complex children.   "
77654|NCT02269423|"     The purpose of this study is to test how safe the vaccine is in humans and how well it makes     the human immune system cause an immune- or defense-response to Ebola virus. This vaccine     will be studied at different doses.   "
77050|NCT02277314|"     The overall objective is to determine the visual outcomes and cost to perform Manual Small     Incision Cataract Surgery (MSICS) in a small cohort at an academic medical center in the     United States. The primary outcome measure will be the percentage of the study group     achieving a post operative visual acuity 20/40 Snellen. This percentage will be compared to     historical cohorts reported for phacoemulsification cataract surgery (PCS), when performed in     academic centers. A secondary outcome will be to determine the actual institutional cost of     providing MSICS in the setting of an academic medical center. The hypothesis is that MSICS is     appropriate for a teaching environment (as evidenced by a comparable rate of 20/40 acuity or     better at 90 days post op, as compared to PCS), and can be provided at a cost that makes     visual rehabilitation affordable to the uninsured and underinsured.   "
77051|NCT02277301|"     This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint     (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted in     three areas of Northern Ireland: Lisburn, North Down & Ards, and Downpatrick. At least 50     women with infants under 13 months old will be recruited during August/September 2014.   "
77052|NCT02277288|"     The purpose of this randomized control trial study is to determine if intraoperative bladder     instillation of fluid decreases the time to discharge after having an outpatient mid-urethral     sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges     will be broken down between recovery room charges and discharge area, as recovery room     charges are significantly higher. The investigators suspect that a shorter time in the     recovery room will translate into fewer charges.   "
77053|NCT02277275|"     High-protein diets better preserve lean mass than conventional low-fat diets. However, they     are costly and have potential health risks. Preserving lean mass is important for sustaining     high resting energy expenditure, leading to greater initial weight loss, better weight     maintenance and improving blood sugar levels. Branched-chain amino acids (BCAA) supplements     are known to preserve lean mass but their effects during weight loss have not been examined.     Investigators want to investigate if a BCAA-supplemented diet is more effective than a     standard hypocaloric diet in terms of the aforementioned benefits, and yet has less     detrimental effects than a high-protein diet for weight loss. Using a 16-week weight loss and     8-week weight maintenance intervention, overweight and obese men and women will be randomized     to either a hypocaloric diet with BCAA or placebo supplements or a high-protein diet with     placebo supplements. Participants' compliance to the diet versus supplements will be     compared. Body composition, resting and diet-induced energy expenditure, insulin sensitivity     will be measured and blood samples taken before and after weight loss. These findings will     inform on the benefits of BCAA-supplementation during energy restriction and may offer an     alternative cost-effective strategy for weight loss and maintenance, without the adverse     health effects of a high-protein load.   "
77054|NCT02277262|"     To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted     preperitoneally as a prophylactic procedure against incisional hernia in patients operated in     urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the     study is to reduce the incidence of incisional hernia from 50% to 20%.   "
77229|NCT02274974|"     Study to compare between efficacy of post-caesarean section infiltration with lidocaine and     epinephrine versus lidocaine only to reduce post-incisional pain.   "
77230|NCT02274961|"     This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non     erosive Reflux Disease than placebo.   "
77055|NCT02277249|"     Current practice for the provision of late second trimester abortion (dilation and     evacuation, or D&E) often involves the administration of digoxin into the fetal compartment     to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally     or transvaginally into the fetal compartment. Both modes of administration have been shown in     prospective studies to be highly effective and safe. Both modes of administration are     considered standard of care. This pilot study will directly compare transabdominal and     transvaginal digoxin with respect to patient preference (i.e, patient pain score describing     discomfort with injection).   "
77056|NCT02277236|"     This pilot study will aid the development of a sonographic screening method used to obtain     proxy measures of LBM and estimates of muscle composition that relate to Intramuscular     adipose tissue (IMAT), lipid metabolism, and insulin resistance. Typically, age-related     muscle loss is not assessed in older adults until they began to show signs of trouble     managing their own lives independently. In addition to the loss of independence that is     typically seen with diminished muscle mass and function (sarcopenia), age-related changes in     lean body mass can have negative effects on insulin sensitivity. The investigators central     hypothesis is that the muscle characteristics derived from ultrasound (US) will be     significantly associated with estimates of dual energy X-ray absorptiometry (DXA) LBM, CT     scan measures of IMAT, estimates of insulin homeostasis, and serum levels of inflammatory     cytokines.   "
77057|NCT02277223|"     Background: Curcumin in an active phytochemical substance, used as part of the human diet,     that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple     experimental models of colitis including a positive effect on maintenance of remission in     adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as     complementary medication in induction and maintenance therapy in pediatric patients with mild     to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study.     Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who     are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or     corticosteroids induction treatment. Main outcome measures: Disease activity defined by the     Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary     outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin     and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version     21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate     associations between primary outcomes and categorical variables. Associations of continues     variables with primary outcome measures will be examined using ANOVA with repeated measures.     P-values <0.05 will be considered significant.   "
77663|NCT02269306|"     The purpose of this study is to determine whether Visceral fat area and other criteria     assessed during initial screening could predict the response to ovulation induction with     clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).   "
77058|NCT02277210|"     Oocyte aspiration under the guidance of transvaginal ultrasound is an integral part in IVF     treatment. Follicular flushing has been advocated. However, subsequent data from randomized     trials failed to demonstrate any benefits with routine follicular flushing in normally     responding patients. Instead, it has been shown to prolong the operating time, increase the     procedure-related pain and analgesics requirement. Most of the IVF centers no longer perform     routine follicular flushing in normally responding patients.      The potential role of follicular flushing in patients with a limited number of developing     follicles is conflicting based on the recently published randomized trials. The aim of the     present study is to determine the effect of follicular flushing on the ongoing pregnancy rate     in patients who developed four or fewer follicles of 14mm following standard ovarian     stimulation for IVF.   "
77059|NCT02277197|"     The epidermal growth factor receptor (EGFR) is both oncogene and prognostic biomarker in head     and neck squamous cell carcinoma (HNSCC). EGFR's functional importance in HNSCC resulted in     development of the first molecularly targeted strategy, the anti-EGFR monoclonal antibody     cetuximab. Given the lack of therapeutic options for patients with recurrent/metastatic HNSCC     after failure of cetuximab, there is strong scientific interest in understanding resistance     in order to identify new therapies for this population. A possible resistance mechanism to     anti-EGFR therapy in HNSCC is primary or compensatory activation of alternate growth factor     receptors including c-Met. The MET oncogene encodes c-Met, an RTK bound exclusively by the     ligand, hepatocyte growth factor (HGF). The HGF/c-Met signaling pathway converges with the     EGFR network at both the PI3K/Akt and MAPK nodes. Laboratory data suggest the ability for     reciprocal compensation between EGFR and c-Met. We hypothesize that HGF/c-Met pathway     inhibition may overcome resistance to cetuximab in patients with HNSCC, such as those with     clinical cetuximab resistance.      Ficlatuzumab (AV-299) is a humanized HGF-inhibitory immunoglobulin G1 (IgG1) monoclonal     antibody. The primary objective of this phase 1b study is to find the recommended phase II     dose (RP2D) of the combination of ficlatuzumab and cetuximab in patients with     recurrent/metastaticHNSCC. The dose-finding study design will follow a Narayana k-in-a-row     design with k set to 2 to target a 33% rate of dose-limiting toxicity (DLT). In the     dose-finding phase, a total of 8 patients will be treated if no DLTs are observed or 14     patients if at least one DLT occurs. An expansion cohort will then proceed at RP2D until 12     patients have been treated at that dose level with the combination of ficlatuzumab and     cetuximab. We will evaluate biomarkers of HGF/cMet pathway activation in baseline tissue,     plasma and immune cells for a preliminary relationship with clinical activity.   "
77060|NCT02277184|"     Head and neck squamous cell carcinoma (HNSCC) is the most common cancer arising in the upper     aerodigestive tract, and is the sixth leading incident cancer worldwide. Despite advances in     multimodality therapy, 5-year overall survival (OS) is 40-60%, and has increased only     incrementally in the past two decades. The current standard of care for primary nonsurgical     management of locally advanced HNSCC is concurrent cisplatin-radiotheray, which significantly     improved OS, progression-free survival, and locoregional control compared with radiotherapy     alone in the landmark Intergroup trial 0126.      The MET proto-oncogene encodes c-Met, a heterodimeric growth factor receptor bound     exclusively by its ligand, hepatocyte growth factor (HGF). In the laboratory, activation of     the HGF/c-Met pathway is associated with resistance to cisplatin and radiotherapy in HNSCC.     We hypothesize that the addition of an HGF/c-Met pathway inhibitor to cisplatin-radiotherapy     may improve outcomes in HNSCC. Ficlatuzumab (AV-299) is a humanized HGF-inhibitory IgG1     monoclonal antibody.      The primary objective of this study is to establish the recommended phase II dose (RP2D) of     the combination of ficlatuzumab, cisplatin and intensity-modulated radiotherapy (IMRT), in     patients with locally advanced HNSCC. The dose-finding study design will follow a Narayana     k-in-a-row design with k set to 3 to target a 33% DLT rate. In the dose-finding phase, a     total of either 10 or 14 patients will be treated. If no DLTs are observed among 10 patients,     the highest dose tier will be declared the RP2D. Otherwise the RP2D will be estimated from     DLTs across all dose levels by isotonic regression. The secondary objective is to estimate     biomarker association with preliminary clinical response. We will evaluate biomarkers of     HGF/cMet pathway activation in tumor tissue, plasma, and immune cells.   "
77086|NCT02276846|"     The aim of the study is to use optical coherence tomography (OCT) to investigate the efficacy     of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent     (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm,     reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch     ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina     classification type in the native coronary artery as reflected by procedural success and to     evaluate the preservation of vessel patency.   "
77061|NCT02277171|"     According to the World Health Organization, hundreds of millions of patients are affected by     health-care associated infections worldwide each year, resulting in prolonged hospital stays,     long-term disabilities, deaths, and financial losses for health systems. The most common     hospital-acquired infection is Urinary Tract Infection (UTI), accounting for almost 40% of     all nosocomial infections. Most hospital-acquired UTIs are associated with catheterization.     In fact, urinary catheter-related bacteriuria is the most common health care associated     infection worldwide. Catheter-associated UTI (CAUTI) develops following adhesion of     planktonic bacteria to the surface of the catheter and colonization, creating a persistent     environment called a biofilm. The nature of biofilm structure together with the physiological     attributes of biofilm organisms confers an inherent resistance to various antimicrobial     agents such as antibiotics, disinfectants or germicides, augmenting the potential of these     pathogens to cause infections in catheterized patients.      Nitric oxide (NO) is a naturally-produced gas molecule with broad-spectrum antimicrobial     activity. NO is used in the clinics to treat pulmonary hypertension in neonates and adults.     Studies have shown that low-dose NO is associated with prevention of biofilm formation,     biofilm dispersal and elimination of bacteria. It is suggested that NO prevents bacteria     attachment to catheter surfaces and inhibits biofilm formation in a mechanism involving     reduction and modification of proteins that mediate cell-substrate and cell-cell     interactions.      The investigators team, using a proprietary technology impregnate urinary catheters with NO     (i.e. NO-impregnated catheters). These catheters release low concentration of NO following     exposure to urine over a 14-day period. In vitro studies showed that NO-impregnated catheters     prevent bacterial colonization and biofilm formation of Escherichia coli on exterior and     luminal surfaces of the catheters. In addition, NO released from these catheters is able to     eradicate up to 4log colony forming unit/ml of bacteria within the surrounding media.     Moreover, NO-impregnated catheters exhibit superior performance compared to silver-coated     catheters, and similar anti-infective properties compared to antibiotic-coated catheters.      Primary objectives: To assess the safety and tolerability of NO-impregnated catheters in     patients older than 18 years old undergoing radical prostatectomy and catheterized for 7-14     days.   "
77062|NCT02277158|"     The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus     radiotherapy for patients with rectal cancer   "
77063|NCT02277145|"     Radiation therapy is one of the main means for treating malignant tumor, during which     radioactive lung injury is inevitable. Currently there is nearly no effective clinical     treatment for late post-radiotherapy pulmonary fibrosis. This study intends to carry out an     open, single-center, non-randomized phase I clinical trial. During the treatment, the local     lesions will be fully lavaged, and then clinical grade umbilical cord mesenchymal stem cells     (MSCs) will be injected directly into the lesion by fiberoptic bronchoscopy. After six-month     observation, the investigators will initially evaluate the safety and effectiveness of the     treatment by measuring two key indicators-the CT density histogram and the patients'     self-evaluation, and one secondary indicator—the changes of TGF-β1 contents, both before and     after the treatment. Meanwhile, the investigators will make a preliminary discuss about the     possible immunomodulatory effects of the umbilical cord MSCs.   "
77683|NCT02269046|"     The purpose of this study is to evaluate the effect of 12 weeks of acupuncture and     moxibustion compared with active control, on absolute and percent change from baseline in     low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.   "
77064|NCT02277132|"     Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency     is associated with a high risk of perinatal morbidity with long-lasting sequelae and     mortality. Placental insufficiency is the result of abnormal formation and function of the     placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental)     arteries. There is currently no therapy available with demonstrated effectiveness. Evidence     suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful     outcomes.      Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy     perinatal survival.      Study design: Multicenter nationwide randomized placebo-controlled clinical trial.      Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal     growth restriction of likely placental origin, and with estimated significant likelihood of     perinatal death.      Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study     parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal     morbidity at term age.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard     clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected     medication-associated risks can't be excluded on beforehand.   "
77065|NCT02277119|"     Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber     Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices   "
77066|NCT02277106|"     Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety,     tolerability, PK, and efficacy of SAGE-547 Injection in male and female patients with     essential tremor in the upper limb.      Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and     effeciveness of SAGE-547 Injection at a higher dose than in Stage 1. Subjects who completed     Stage 1 will be invited to participate in Stage 2.   "
77067|NCT02277093|"     The investigators propose to assess the efficacy, progression-free survival, and adverse     events of pacritinib in patients with refractory colorectal cancer.   "
77068|NCT02277080|"     The primary aim is to investigate the dose and time dependent effects of different opioids on     the immune and endocrine systems.      The secondary aim is to investigate whether associations between the function of the immune     and endocrine systems and opioid use influence cognitive function, pain and quality of life.   "
77069|NCT02277067|"     We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in     high risk patients after C.S.   "
77070|NCT02277054|"     In this study the safety and effectiveness of biosynthetic cornea, comprising     interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested     in patients with severe corneal pathology (corneal ulcers or corneal opacification from     corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the     only widely accepted treatment) carries a high risk of rejection.   "
77071|NCT02277041|"     We will compare efficacy and safety of Carbetocin with Misoprostol in prevention of     postpartum hemorrhage in Placenta previa women after C.S.   "
77072|NCT02277028|"     This study will compare bilateral priming followed by task specific training to health care     education followed by the same task specific training protocol. The intention is to     understand the effects of priming on upper limb training post-stroke.   "
77073|NCT02277015|"     The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines     suggest that intubators should be able to secure the airway without interrupting chest     compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope     (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for     endotracheal intubation (ETI) during pediatric resuscitation with and without chest     compressions.   "
77074|NCT02277002|"     Traffic related air pollution is a well-recognised and much studied contributor to smog and     is linked to a number of adverse health outcomes. Although traffic pollutants can travel long     distances, exposure to the highest levels of the raw emissions can occur closest to the     source; e.g. in a car in dense traffic conditions. Time spent in-vehicle may contribute up to     half of commuters' daily exposure to certain air pollutants. Most new cars now have or allow     for a cabin air filter, but it is not known how well cabin air filtration can reduce exposure     to traffic-related air pollution.      This intervention study will measure commuters' exposure to air pollutants in rush hour     traffic. It will evaluate the impact of this exposure on stress hormones in saliva, and short     term cardiopulmonary health indicators such as blood pressure, heart rate variability and     respiratory inflammation. It will also look at effects on cognition (mental processing and     judgement) in this real world environment where any deficit could be important to safety. In     addition, the study will examine whether cabin air filtration can reduce the exposure to     traffic related air pollutants and result in improvements in short term cardiopulmonary and     cognitive function. This research will contribute to our understanding of how this     environment contributes to Canadians' overall air pollution exposure as well as the potential     health impacts. It will also test a potentially valuable and economical means of reducing     exposure to traffic related air pollution in a commuting environment. The study may also     guide the future implementation of the use of cabin filters as an exposure reduction     intervention.      Overall Project Objectives:      Can cabin air filtration effectively reduce exposure to traffic related air pollution? Does     commuter exposure to air pollution affect short term stress, and cardiopulmonary and     cognitive function? Can cabin air filtration mitigate the health effects of commuters'     exposure to air pollution?   "
77075|NCT02276989|"     In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain     and on buprenorphine therapy, this study will investigate the utility and feasibility of two     novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor     adherence to study drug prescription in the parent clinical trial.   "
77076|NCT02276976|"     The purpose of this study is:1)to observe topological organization in brain structural and     functional networks in cerebral white matter lesion patients and to evaluate the association     between impairment of cognitive function and cerebral structural and functional networks in     those patients;2)to indicate the role of genetic factors in the occurrence and prognosis of     cerebral white matter lesions   "
77136|NCT02276196|"     Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based     therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4     inhibitors, may hold promise in preventing the onset and progression of diabetic kidney     disease. However, the potential renoprotective effects of these agents, that are believed to     be effectuated beyond glucose control, have not been sufficiently detailed in human     diabetes.      Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1     receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes.      Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention     with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.   "
77077|NCT02276963|"     Ublituximab (also known as LFB-R603) is a monoclonal antibody that specifically binds to the     trans-membrane antigen CD20. The binding induces immune response that causes lysis of B     cells.      The rationale for using ublituximab in neuromyelitis optica (NMO) and neuromyelitis optica     spectrum disorder (NMOSD) is based on the known roles of B cells, antibody production and     plasma cells in the pathophysiology of NMO. NMO is characterized by the presence of an     anti-AQP4 antibody, which can only be produced by differentiation of B cells to plasma cells.     Because these anti-AQP4 antibodies may be pathogenic, B cells recognizing AQP4 may be     directly involved in the disease process as well. B cells also play a role as potent antigen     presenting cells in NMO. The strongest evidence of the importance of B cells in NMO comes     from studies of B cell depletion, most commonly with anti-CD20 monoclonal antibody, rituximab     (Rituxan®).      Rituximab has been shown in five retrospective and two prospective studies to be effective in     reducing NMO relapses up to 90% and achieving remission in up to 80% of patients solely by     its action on CD20+ B cells, despite no change in plasma cell population and anti-AQP4     antibody titers. These human trials strongly suggest a critical role for B cells in the     pathophysiology of human disease. While typically used in the prevention of disease, B-cell     depletion may be beneficial in the treatment of an acute relapse as well. Emerging evidence     indicates that peripheral B cells are activated during a relapse and plasmablast production     of anti-AQP4 antibodies spikes. B cells are also found within acute lesions of the spinal     cord and optic nerve suggesting roles both in the blood and in the central nervous system     during a relapse.   "
77078|NCT02276950|"     The overall project aim is to study risk and outcomes following cardiac surgery by     cross-linking high-quality national Swedish health-data registers for population-based     investigations of individual level clinically relevant patient data.   "
77079|NCT02276937|"     DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on     recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human     fibroblast growth factor-2 (FGF-2) gene. The previous Phase I/IIa study demonstrated no     serious adverse event related to the administration, and suggested possible improvement of     local blood flow and walking performance of PAD patients.      The primary objective of the current Phase IIb study is to investigate the clinical efficacy     of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC. We also aim to examine the     dose-response relationship using the rate of improvement in walking function as an indicator.   "
77080|NCT02276924|"     Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year.     The standard treatment for these tumors is the ablation of the kidney, ureter and a part of     the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment     techniques through natural routes opens the possibility to use conservative treatments. The     investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will     allow the discrimination between normal and pathologic urothelium by microscopic analysis.     This will prevent the systematic use of biopsies which are often difficult and iatrogenic.   "
77081|NCT02276911|"     A prospective, randomized, placebo controlled, double-blinded study at a single institution.   "
77082|NCT02276898|"     The Lung Clearance Index (LCI) is a non invasive measure of lung function that is more     sensitive than FEV1. It can be used to measure lung function in children younger than 6 years     of age. Therefore, it has a future role in assessing novel therapeutics in the Cystic     Fibrosis (CF) population. As such, determining if it can be used as a short term     pharmacodynamic biomarker is paramount.   "
77083|NCT02276885|"     The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5     days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five     consecutive days   "
77084|NCT02276872|"     This is a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral     treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who are, (1)     transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin     therapy; or (3) not currently receiving prostacyclin therapy.   "
77085|NCT02276859|"     Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as     bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h     post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG)     (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking     part under in-patient clinical conditions.   "
77104|NCT02276612|"     This study will assess the safety, efficacy and tolerability of     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected     virologically suppressed adolescents 12 to < 18 years of age.   "
77087|NCT02276833|"     Autologous adipose-derived stromal vascular fraction (SVF) was used to treat 10     osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a     feasibility and safety study. The adipose-derived SVF was obtained through disaggregation of     lipoaspirate and resuspension of the SVF in 3 ml of Lactated Ringer's Solution, with a mean     of 48 million nucleated SVF cells and a mean viability of 78%, injected per knee. Cell     suspension was injected into the intra-articular space using ultrasound guidance. At 12 weeks     post-op all 10 knees showed decreased pain and increased mobility, both statistically     significant (α = .01). Nine of ten knees reported either maximum possible or very significant     decrease in pain. No infections, acute pain flares, or other adverse events were reported.     Patient ages ranged from 52 - 69 years with a mean of 59 years.   "
77137|NCT02276183|"     Bone and muscle losses occur during ageing leading to increased risk of osteoporosis (there     are more than 200 million people affected by osteoporosis worldwide), sarcopenia, loss of     functionality and mobility. From around 45-50 years onwards, there is a progressive loss of     muscle mass and strength (sarcopenia). This is partially due to an impairment of muscle     protein synthesis in response to dietary proteins. Insufficient dietary protein may     contribute to age-related loss of lean body mass (LBM) and strength which ultimately affects     body movement.      Key ingredients in selected investigational product are:Milk proteins, Calcium, Vitamin D,     Vitamin C, Glucosamine Sulfate, Zinc. They have effects to improve physical mobility and     functionality. The investigators expect improved effects of a nutritional intervention     combined with a physical activity program on mobility in healthy aging subjects with joint     discomfort.   "
77088|NCT02276820|"     Patients enrolled on this study will have received a stem cell transplant. After a     transplant, while the immune system grows back the patient is at risk for infection. Some     viruses can stay in the body for life, and if the immune system is weakened (like after a     transplant), they can cause life-threatening infections.      Adenovirus (AdV) is a virus that just causes symptoms of a common cold normally, but which     can cause serious life-threatening infections in patients who have weak immune systems. It     usually affects the lungs and can cause a very serious pneumonia, but it can also affect the     gut, the liver, the pancreas and the eyes.      Investigators want to see if they can use a kind of white blood cell called T cells to treat     adenovirus infections that occur after a transplant. Investigators have observed in other     studies that treatment with specially trained T cells has been successful when the cells are     made from the transplant donor. However as it takes 1-2 months to make the cells, that     approach is not practical when a patient already has an infection.      Investigators have now generated AdV-specific T cells from the blood of healthy donors and     created a bank of these cells. Investigators have previously successfully used frozen     virus-specific T cell lines generated from healthy donors to treat virus infections after     bone marrow transplant, and have now improved the production method and customized the bank     of lines to specifically and exclusively target AdV.      In this study, investigators want to find out if the banked AdV-specific T cells derived from     healthy donors are safe and can help to treat adenoviral infection.      The AdV-specific T cells (Viralym-A) are an investigational product not approved by the Food     and Drug Administration (FDA).      Funding source - FDA OOPD   "
77089|NCT02276807|"     The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a     brief educational individual workshop that is meant to help Veterans better understand     feelings of sadness and ways to improve their mood. This study is intended to evaluate and     establish the workshop's effectiveness for use with Veterans in primary care settings.      The study involves up to 6 in-person meetings and 6 telephone interviews across a 6-month     period of time. Approximately 144 Veterans will participate in the study. Using a procedure     like the flip of a coin, the participants will have a one in two chance of receiving the     brief educational workshop or treatment as usual condition.   "
77090|NCT02276794|"     This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk     Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.   "
77091|NCT02276781|"     The investigators hypothesize that among people with lower extremity peripheral artery     disease (PAD), biomarker levels are higher during time periods immediately preceding an acute     coronary event compared to time periods not immediately preceding an acute coronary event.     Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be     measured at baseline and every two months during follow-up.      The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD     who experience an acute coronary event during follow-up, the investigators will determine     whether biomarker levels measured immediately prior to the coronary event are higher than     levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The     investigators will determine whether participants who experience a coronary event (cases)     have higher biomarker levels at the visit immediately prior to the event than participants     who have not experienced a coronary event (controls) at the time of the case event. Specific     Aim #2, Part 2. The investigators will determine whether participants who experience a     coronary event (cases) have a greater increase in biomarkers during the time period leading     up to the event compared to participants who have not experienced a coronary event     (controls).      To achieve these aims, the investigators will enroll up to 650 participants with PAD and     follow them prospectively, measuring blood samples every two months, and ascertaining the     presence of acute coronary events every two months.   "
77092|NCT02276768|"     This study evaluates colonic analgesia by comparing two novel formulations, GIC-1001 and     GIC-1002 with placebo using a barostat distender. The healthy male and female volunteers     randomized to one of 5 possible treatments will be exposed to rectal distension following a     3-day treatment TID. The barostat methodology is a well-established and validated way to     assess visceral pain. Visceral pain will be evaluated during exposure to varying distender     pressures using a visual analog scale.   "
77093|NCT02276755|"     The goal of this clinical trial is to investigate the preventive role of vitamin D     supplementation in school age children in a high transmission setting. The investigators     hypothesis is that (1) vitamin D supplementation will reduce rate of acquisition of LTBI, (2)     vitamin D supplementation will lead to greater reductions in active TB incidence, and (3)     children with the lowest vitamin D status at baseline will gain most from the intervention.   "
77105|NCT02276599|"     This study is designed to investigate the ability of pleth variability index (PVI) to     non-invasively predict fluid responsiveness in mechanically ventilated children. Patients     undergoing atrial septal defect (ASD) repair in the cardiac catheterization suite will be     recruited for this study. These patients are ideal candidates because very few deviations     will be made from standard clinical practice. All patients will already be under general     anesthesia, mechanically ventilated, monitored with pulse oximetry, and provided with     intravenous fluid to compensate for their nil per os (NPO) fluid deficit. The only deviation     from clinical practice will include an abbreviated echocardiographic exam, application of the     Masimo pulse oximeter, and measurement of CO via a thermodilution catheter by the     interventional cardiologist.   "
79412|NCT02246439|"     Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal     Release Tablets) for Acute Gastroenteritis.      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute     Gastroenteritis, by comparing it to placebo.   "
77138|NCT02276170|"     Acute kidney injury (AKI) in critically ill neonates is common and associated with     significant morbidity and mortality. No targeted therapeutic treatment strategies have been     established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic     conceptual framework, this project will examine the medication aminophylline as a potential     treatment approach for AKI.   "
77139|NCT02276157|"     This study was aimed to evaluate of the success rate and clinical usefulness of direct     peroral cholangioscopy by using an ultra-slim upper endoscope for the diagnosis and treatment     of bile duct diseases.   "
77094|NCT02276742|"     The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different     technology-supported approaches to engaging 300 individuals with diabetes and concurrent     chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of     inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4     groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile     self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT     plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms     primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and,     secondarily in terms of physical activity, blood pressure, fasting lipids, medication     requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months.     The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on     logistic generalized linear mixed models (for binary outcomes) linear mixed models (for     continuous outcomes), and random effects multinomial models (for outcomes with more than 2     levels, such as changes in medication management). In separate analyses of the intervention     arm only, investigators will model self-monitoring adherence and examine possible     associations between self-monitoring adherence and outcomes. The mediating effect of     self-efficacy on the primary outcomes will be evaluated using structural equation models.   "
77095|NCT02276729|"     Individuals who have sustained a stroke are often left with residual deficits of the upper     limb such as impaired movement and sensation. These deficits restrict functional use of the     limb in everyday activities and can result in increased dependency upon others to engage in     some tasks. Regaining independence through functional use of the arm and hand is an aim of     occupational therapy rehabilitation. Mirror box therapy (MBT) is a relatively new innovation     being introduced into occupational therapy interventions. Some studies have reported it to be     beneficial in upper limb rehabilitation, however, these studies have not involved a sub-acute     stroke population. This pilot study aims to provide robust evidence, using RCT design, as to     whether this type of therapy may offer greater potential in functional gains in the sub-acute     recovery period of stroke than standard rehabilitation of the upper limb alone.   "
77096|NCT02276716|"     Familial dysautonomia (FD) is a devastating hereditary disease in which the development of     selective neuronal populations is impaired because of a deficiency of the protein IKAP     (Slaugenhaupt, 2002). There is no known cure. Treatments are supportive, often ineffective     and around half of all patients die before reaching age 40 (Axelrod et al., 2002).      Phosphatidylserine is an FDA approved food supplement that was shown recently to correct the     genetic abnormality and restore IKAP protein levels in cell lines derived from patients with     FD (Keren et al., 2011) and a humanized mouse model of the disease (Bochner et al., 2013).     Despite its safety and efficacy in this fragile population being unknown, many patients with     FD are currently taking phosphatidylserine      The investigators propose to conduct a safety, tolerability and early proof of concept     efficacy study of phosphatidylserine in patients with FD. The study will be divided into two     independent arms. The first phase of the study will be an open-label dose titration study to     determine the safety and optimal dose of phosphatidylserine and its effect of normal IKBKAP     mRNA levels in 40 patients with FD. The second phase will be a longitudinal observational     study in which we will follow, on a yearly basis, patients with FD of all ages who opt to     take phosphatidylserine. In this study, we will evaluate the long-term safety of     phosphatidylserine in patients with FD and hope to determine whether phosphatidylserine has     any impact on the clinical evolution of the disorder.      Our long-term goal is to find an effective therapy that will improve the quality of life for     patients with FD and alter disease prognosis. We believe that the promise of     phosphatidylserine and its availability in health food shops warrants a controlled safety,     tolerability and efficacy study to determine whether it should be taken by patients with FD.     This study is not intended to determine whether phosphatidylserine has a new indication to     treat FD.   "
77097|NCT02276703|"     Pain in hospitalized patients has received increasing attention, however due to its     subjective nature, it has defied objective, quantitative measurements. If a patient is able     to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS)     or plain numeric scales.      When a patient is unable to communicate, a method that would allow the caregiver to     continuously monitor patients' pain and alert the provider that the patient may be in pain     would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing     changes in skin conductance that can be used in patients who are unable to provide a     subjective pain score. This study will compare the relationship between the measurements     taken by the PainMonitor and pain scores given by communicative patients to evaluate the     safety and efficacy of this monitor during planned, routine procedures.   "
77098|NCT02276690|"     Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at     admission and more than 80% at intensive care unit discharge. Iron deficiency is also     frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care     Unit, critically ill patients are exposed to repeated blood samples and to other blood losses     (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to     direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care     Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since     inflammation induces an increase in plasma ferritin levels and a decrease in transferrin     saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is     usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to     correct anaemia but also to improve patients fatigue and muscular weakness. The     characterization of iron metabolism regulation by the hormone hepcidin opened new ways for     the understanding and the follow-up of these complex clinical situations (combining     inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in     hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin     levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker     of iron deficiency in critically ill patients. To date, standard immunological methods of     hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in     the clinical setting because it is too expensive. New approaches for hepcidin quantification,     based on mass spectrometry are proposed and may be routinely implemented. We make the     hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by     hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may     thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment.      The aim of this study is to evaluate the medical economic interest of a new diagnostic method     for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in     critically ill anaemic patients.   "
77099|NCT02276677|"     Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the     mechanisms for this effect in humans is not yet clear.      In this study, the investigators will therefore examine the effect of a single dose of     intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and     functional magnetic resonance imaging activation of areas of the brain involved in food     motivation.   "
77100|NCT02276664|"     The purpose of this study is to develop and test a self-help smoking cessation treatment for     patients receiving a lung cancer screening computed tomography (CT) scan.   "
77101|NCT02276651|"     Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid     leukemia in complete Remission (consolidation therapy)   "
77102|NCT02276638|"     The primary objective of this clinical study is to collect clinical data to support an FDA     510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The     secondary objective is to evaluate any adverse events found during the clinical study.   "
77103|NCT02276625|"     To determine optimum dose level for a single visit multidose intradermal injection of rabies     vaccine with the aim to induce immunological memory in all subjects.   "
77106|NCT02276586|"     Background: The actual literature is consistent in considering potential negative effects of     sub-gingival prosthetic margins on the periodontal health, but no research has focused the     attention on the type of prosthetic margin designs. Hence, the aim of the present study is to     evaluate if a horizontal finishing line (deep chamfer preparation) may have a different     influence on periodontal soft tissue in comparison with a vertical finishing line (feather     edge preparation).      Methods: A prospective randomized controlled double blind clinical trial with one single     operator and three experienced examiners was performed. One hundred and six crowns were     prepared with horizontal tooth preparation while ninety-four with vertical tooth preparation.     All the margins were positioned within the periodontal sulcus, at 0.5mm sub-gingivally and     all the all-ceramic restorations were cemented with resin cement. Periodontal Probing Depth     (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival Bleeding on Probing (BOP) were     recorded prior to tooth preparation and twelve month after crown cementation. Also, at 12     months follow-up, the gingival margin position was related to the crown margin position.   "
77107|NCT02276573|"     Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1     to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and     debilitating is characterized by erosive areas, ulcerated on an erythematous base with or     without a keratinocyte lichenien network.      The literature data moving towards an autoimmune origin, but the pathophysiological     mechanisms of OLP remain unknown.      This project represents the first part of a comprehensive project to examine the oral     pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on     Epstein-Barr Virus (EBV).   "
77108|NCT02276560|"     The purpose of this research study is to determine whether giving cisplatin and     nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the     lung at the time of surgery.   "
77109|NCT02276547|"     The purpose of this study is to evaluate the safety and initial performance of the Neovasc     Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.   "
77110|NCT02276534|"     The investigator's goal is to address the need for the development of social interventions     for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends     established behavioral strategies with theatre techniques that emphasize the involvement of     peers, play and performance. The resulting synergy extends promising pilot studies in a     randomized group experiment.   "
77111|NCT02276521|"     In Fiji, cervical cancer is the second most frequent cancer and the highest cause of cancer     mortality in women. In 2008/9, the Ministry of Health in Fiji accepted a donation of 110,000     doses of quadrivalent HPV vaccine, Gardasil® based on the high cervical cancer disease     burden. There was enough vaccine to vaccinate all girls aged 9-12 years (30,338 girls) with a     three-dose schedule, but not all girls received three doses of the vaccine. This means those     girls that received reduced doses may not be fully protected against the HPV genotypes     present in the Gardasil®. While HPV vaccines are highly immunogenic and efficacious in the     licensed three-dose schedule, there is limited information about the effectiveness of reduced     dose schedules in terms of immunogenicity and memory. There is growing evidence from other     studies that two doses of HPV vaccine may be sufficient for protection. Reduced schedules     would be of benefit in Fiji due to improved costs and logistics. This study will examine     whether one or two doses of HPV vaccine provide similar immunological evidence of long-term     protection to the standard three-dose schedule in terms of antibody titres to the genotypes     present in the Gardasil®. To compare immunological memory responses between dosage groups, a     dose of Cervarix ® will be administered to all girls so that the magnitude of the memory     responses can be measured.   "
77112|NCT02276508|"     Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat     gastrointestinal disorders and infections. The investigators will assess the safety and     tolerability of this medication in Americans in a Phase 1 trial.   "
77113|NCT02276495|"     The purpose of the study is to determine the effect of a single injection adductor canal     block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).   "
77115|NCT02276469|"     The purpose of this study is to determine wether peer support is effective for the treatment     of people with severe mental illness.   "
77116|NCT02276456|"     With no prior prospective study to demonstrate the benefit of an early post-discharge     follow-up appointment in reducing readmission rates in the post-myocardial infarction (MI     patient population, we propose to conduct the first randomized, prospective trial to better     elucidate the association between early and standard follow-up on readmission rates. The     investigators hypothesize that unlike heart failure or advanced valvular disease patients,     the benefit of early outpatient follow-up in reducing readmission of post-MI patients will be     less clear. Thus, the investigators primary aim will be to determine the effect of early     outpatient follow-up post-discharge on 90 day all-cause readmission rates (exclusive of     planned readmissions known at the time of discharge). Secondary aims are to describe 1)     causes of readmissions within 90 days, 2) any cardiovascular-related complications and any     deaths that occur from discharge through 90 days, 3) 30-day readmission rates and 4) median     time to readmission among those readmitted. Finally, the investigators will examine the     distribution of demographic, clinical and socioeconomic characteristic according to     readmission vs. no readmission. The investigators do not expect to have sufficient endpoints     for full predictive modeling, but believe this exploratory work will provide a foundation for     future studies. The investigators postulate that the design and methodology of our current     study could be used to answer similar questions in other subsets of patients.   "
77117|NCT02276443|"     The goal of this clinical research study is to learn if the use of molecular testing on     tumors can improve response to treatment in patients with TNBC by guiding patients with     chemotherapy-sensitive tumors to receive standard chemotherapy and chemotherapy-insensitive     tumors to consider a clinical trial. Researchers want to compare the outcome of a study group     which receive results of these tests with a group of patients who do not receive the results.   "
81826|NCT02214940|"     First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of     BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in     a statistical sense defined)   "
77118|NCT02276430|"     Testicular cancer (TC) is a rare disease, which mostly affects young men aged 15-35 years.     Their life expectancy has greatly improved due to the introduction of platinum-containing     chemotherapy for disseminated TC in the late 1970s. Given the good prognosis of TC nowadays,     prevention or early detection of late adverse effects of TC treatment has become increasingly     important. Current literature suggests that TC treatment, and specifically exposure to     platinum agents, is associated with increased risk of cardiovascular morbidity and mortality.     The precise role of treatment components like platinum in the pathogenesis of cardiometabolic     changes and cardiovascular disease (CVD) warrants further investigation, since it is not     known if CVD develops through direct platinum-induced damage of the vascular wall or by     mediation through development of cardiometabolic riskfactors. The aim of this study is to     identify risk factors for development for CVD after treatment for TC. A more profound insight     into pathophysiologic mechanisms and identification of risk factors for CVDs is needed to     facilitate development of preventive strategies and to optimize survivorship care.   "
77119|NCT02276417|"     The purpose of this study is to define the natural history and causes of chronic critical     illness (CCI) in surgical intensive care patients who have had sepsis. The investigator also     wants to define the long-term physical and cognitive outcomes of this disease. The     investigator will be looking at many clinical variables to try to define CCI.   "
77120|NCT02276404|"     Breast cancer surgery is associated with presurgical psychological distress and clinically     significant side effects including postsurgical pain, nausea and fatigue. A few studies have     examined how to intervene to assist women undergoing breast cancer surgery. For example     presurgical hypnosis has been proven to decrease side effects and even intraoperative     anesthesia use. Besides the more psychologically based interventions there are a few studies     suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery     patients.This study aims to investigate whether a presurgical relaxation training,     acupuncture treatment or a combination of both therapies is able to reduce presurgical     psychological distress an postsurgical side effects in breast cancer patients in comparison     to usual care.   "
77121|NCT02276391|"     To establish bioequivalence of telmisartan orally administrated in two different ways: either     with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or     with two telmisartan 40 mg tablets   "
77122|NCT02276378|"     To investigate the relative bioavailability and pharmacokinetics of the fixed-dose     combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after     food intake in comparison with those in the fasting state in healthy Japanese male volunteers   "
77123|NCT02276365|"     The objective of the study was to investigate whether there is a drug-drug interaction     between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore, the     relative bioavailabilities of BI 10773 and pioglitazone were determined when both drugs were     given in combination compared with BI 10773 and pioglitazone given alone.   "
77124|NCT02276352|"     Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type)     compared to one 15 mg meloxicam tablet (American type), and to investigate     dose-proportionality over the dosage range 7.5 mg to 15 mg   "
77125|NCT02276339|"     This study aims to investigate the activity patterns of the peroneal muscle group, in     individuals with a history of chronic ankle instability (CAI) of the ankle injuries compared     with individuals without ankle problems. The study also aims to determine the effect of a     targeted exercise programme on this muscle group in patients with CAI.      Research on this topic may provide important insight on the roles of these muscles in chronic     ankle instability and investigate whether specific strengthening programmes are effective in     this complex patient category.   "
77126|NCT02276326|"     Aim of the study is to evaluate the effects of a change in the intestinal microflora on the     neuro-cognitive profile of patients with HIV infection receiving HAART treatment.     Improvements will be evaluated with questionnaires on Quality of life and Cognitive and     Behavior function.      20 patients will be enrolled and will receive 4 sachets of VSL#3 per day.   "
77127|NCT02276313|"     BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to     collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter     in the treatment of atherosclerotic disease of the infrainguinal arteries.   "
77128|NCT02276300|"     Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast     or gastric cancer with moderate HER2/neu expression.   "
77129|NCT02276287|"     Background: the study aimed to explore HIV positive patients' perceptions toward illness and     treatment, and their associations with demographic and clinical variables, in particular with     adherence.      Methods: the study was conducted at the outpatients clinic of Infectious Disease of a     University Hospital in the north of Italy. Patients were asked to fill out the Illness     Perception Questionnaire-Revised. Patient's adherence was measured by: viral load (HIV-RNA     copies/ml) and presence at the check up.   "
77130|NCT02276274|"     This is a randomized, open-label, crossover study to determine the effect of food when a     combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as     SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after     breakfast in Japanese healthy adult male subjects.   "
77131|NCT02276261|"     This study has been designed as a prospective randomized trial to be performed at Bridgeport     Hospital. Patients planning to undergo a laparoscopic or robotically assisted total     laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by     the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their     preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If     enrolled, they will be assigned a sequential study identification number. During their     preoperative exam, a baseline POP-Q will be performed. Demographic information will be     recorded from the electronic medical record.   "
77132|NCT02276248|"     This study is to evaluate the efficacy and safety of radiotherapy combined with GDP     (gemcitabine, cisplatin, dexamethasone) chemotherapy in stage I/II extranodal natural     killer/T-cell lymphoma patients with unfavorable prognostic factors.   "
77133|NCT02276235|"     The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the     therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of     life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese     women.   "
77142|NCT02276118|"     Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee     system with a unique ball and socket post-cam mechanism was developed for use in total knee     arthroplasty. This study aims to determine (1) whether the use of E.Motion-PS-Pro improves     prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared     to an established successful prosthesis, Genesis II (Smith & Nephew, Memphis, U.S.A.), (2)     whether patients with this new prosthesis experience less pain and faster wound healing in     early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster     than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are     higher than those of patients with Genesis II.   "
77143|NCT02276105|"     The purpose of this study is to determine how appropriate and practically is the EQ-5D     questionnaire in use on patients with carpal tunnel syndrome undergoing surgery along the     change of quality of life.   "
77144|NCT02276092|"     This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the     length of stay of patients admitted to hospital with a diagnosis of pneumonia. The     antimicrobial stewardship program will be implemented in several hospitals in Ontario,     Canada. The program will identify patients with pneumonia, review their charts and make     recommendations to their attending physicians about antibiotic management.   "
77145|NCT02276079|"     The study is a proof-of-principle project to examine the safety and feasibility of     implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic     brain injury (mTBI). The study will define the extent to which the exercise program improves     recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical     status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration).   "
77146|NCT02276066|"     This study investigates the mechanism by which kidney dysfunction perpetuates inflammation,     immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will     test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic     critical illness contributes to decreased survival through the development of PICS. In     chronic critical illness, the persistence of the inflammatory state may lead to capillary     rarefication in the kidney causing accelerated chronic kidney disease. Progression of chronic     kidney disease during chronic critical illness can drive PICS. Indeed, many of the features     of chronic critical illness are consistent with the protein-energy malnutrition and muscle     wasting associated with chronic kidney disease. Thus, the kidney can play a contributory role     in chronic critical illness and PICS.   "
77147|NCT02276053|"     This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is     effective in routine clinical practice for patients with epilepsy caused by a brain tumor.   "
77148|NCT02276040|"     The purpose of this study is to quantify the total blood serum levels of bupivacaine in     OrthoPAT® collected blood 2 hours and 5 hours postoperatively.      Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or     undetectable levels of bupivacaine HCL. Reinfusion of collected blood from the OrthoPAT®     device when used in conjunction with periarticular bupivicaine injections will not pose a     bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.   "
77149|NCT02276027|"     To investigate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162   "
77231|NCT02274948|"     This study expects to evaluate the use of metformin in the management of obese children.     Insulin resistance among obese Sri Lankan children (south Asian origin) is high, which had     been shown in the investigators previous work.      This study will look at the effect of metformin on changes in insulin resistance, fatty liver     state, body fat content, BMI and other metabolic derangement.   "
77150|NCT02276014|"     Summary:      Chronic intake of foods low in vitamin A (retinol) and provitamin A forming an unbalanced     diet with little variety is common in young individuals in the United Kingdom (UK) population     and can lead to subclinical micronutrient deficiency. Provitamin A sources such as β-carotene     are cleaved centrally by the β-carotene 15,15'-monooxygenase (BCMO1) into retinal, the     precursor of retinol. However, the amount of β-carotene and retinol produced after ingestion     of β-carotene is highly variable between healthy individuals, with approximately 40% of the     subjects being classified as low responders. Several stable isotope studies have shown a     large disparity between the most efficient converters and the most inefficient converters of     β-carotene with variations of up to 8-fold. It is possible that differences in β-carotene     response may be due to single nucleotide polymorphisms (SNPs) in genes involved in aspects of     β-carotene conversion. Previous work has shown that carriers of both, the 379V and 267S+379V     BCMO1 variant alleles had a reduced ability to convert β-carotene. More importantly, 44% of     the western population have the 379V haplotype. A high percentage of the Western population     may therefore not be able to achieve adequate vitamin A intake if dietary β-carotene is a     major source of their vitamin A intake. This is of particular relevance to vegetarians, to     young individuals aged 19-24 years who have lower intakes of preformed retinol than any other     age group, and to pregnant women. The aim of this study is to establish whether the maximum     recommended dose for β-carotene of 7mg/day by the British Expert Committee on Vitamins and     Minerals (EVM) can overcome the SNP effect in the BCMO1 enzyme.      Hypothesis:      The investigators hypothesize that the current maximum recommended intake of 7 mg of     β-carotene per day cannot overcome the low convertor phenotype in BCMO1 to fulfill vitamin A     requirements in these people.   "
77151|NCT02276001|"     The primary objective of this study is to assess the effects of cyclosporine on the     pharmacokinetics of K-877 in healthy adult subjects.   "
77152|NCT02275988|"     The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics     of K-877 in healthy adult subjects.   "
77153|NCT02275975|"     The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of     K 877 in healthy adult subjects.   "
77154|NCT02275962|"     The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of     K-877 in healthy adult volunteers.   "
77155|NCT02275949|"     This study will evaluate acupuncture's effect of preventing vasospasm after SAH.      A total of 80 participants will be recruited and will be randomized to a study group or a     control group. Acupuncture, electroacupuncture and intradermal acupuncture will be done at     every session in a study group, while mock transcutaneous electrical nerve stimulation(mock     TENS) and sham intradermal acupuncture will be carried out in a control group.   "
77156|NCT02275936|"     This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the     safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR)     modulator at doses near the expected therapeutic exposure level in preparation for Phase 2     studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.   "
77157|NCT02275923|"     The purpose of this study is to investigate the use of subcutaneous impedance measured with     an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status     monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous     impedance and compare with the fluid status assessed by the volume removed from the     hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be     evaluated between dialysis sessions.   "
77158|NCT02275910|"     This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be     conducted in 2 parts:        1. Part 1 will be the dose escalation portion of this study to determine the maximum          tolerated dose in subjects with solid tumors, and        2. Part 2 will comprise cohort expansions to further characterize the safety and          tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid          tumors characterized by genetic abnormalities in FGF/FGFR pathway.   "
77159|NCT02275897|"     The purpose of this study is to investigate if prolonging the speed of injection during     spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements     thereby making it safer for the mother and foetus.   "
77160|NCT02275884|"     This study evaluates plasma concentrations of pharmacologically active constituents of     chocolate and their effects on motor and non-motor symptoms of Parkinson's disease. Following     one week of abstinence from cocoa-containing products, patients with Parkinson's disease will     be randomized to receive either dark or white chocolate. After one week of chocolate     consumption, patients will then cross over to white or dark chocolate, respectively, and take     the corresponding chocolate product for another week. Blood samples will be taken at     baseline, week 1 and week 2 to examine plasma concentrations of pharmacologically active     constituents of chocolate at all three timepoints. Moreover, patients will be clinically     examined for motor and non-motor symptoms at all visits.   "
77161|NCT02275871|"     This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to     MRI as a screening tool for breast cancer.   "
77162|NCT02275858|"     Balloon assisted enteroscopy has revolutionized the management of small bowel diseases by     enabling endoscopic access deep into the small bowel. Using a combination of antegrade     (through the mouth) and retrograde (through the anus) approaches, a large portion of the     small bowel can be examined. Access to the proximal small bowel through the pylorus using the     antegrade approach is straightforward but intubating the distal small bowel through the     ileocecal valve is challenging due to the flexibility of the enteroscope. Recently, an     enteroscopy stiffening wire has been developed. The purpose of our double blind placebo     controlled randomized cross over study is to evaluate the performance of the enteroscopy     stiffening wire in achieving terminal ileum intubation (TI) during retrograde balloon     assisted enteroscopy.   "
77163|NCT02275845|"     Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk     for GDM, an open label randomized controlled trial' The Medico-GDM trial   "
77164|NCT02275832|"     The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for     beard enhancement.   "
77165|NCT02275819|"     This is a research study being conducted to better understand the impact of exercise training     on changes on the structure and function of the heart. Exercise training in patients with     heart failure has been shown to be beneficial at decreasing symptoms of heart failure and     improving overall functional capacity or capacity to exercise. However the mechanisms     responsible for this are still unclear. This study will look specifically at how exercise     creates changes within the hearts filling ability, the hearts pumping strength as well as the     hearts ability to rebuild.   "
77232|NCT02274935|"     This study examines the effect of balance and walking exercise on cognition and mobility in     people with Multiple Sclerosis.   "
77168|NCT02275780|"     To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy     and safety of doravirine will be determined relative to a protease inhibitor (PI).     Participants will receive double-blind treatment during the 96-week Base Study. Eligible     participants in either of the Base Study groups will continue to receive the     doravirine-containing regimen open label for an additional 96 weeks in the Extension Study.     The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to     darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or     EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid     (RNA) <50 copies/mL at Week 48. If non-inferiority is established, then the superiority of     doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be     assessed.   "
77169|NCT02275767|"     The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to     examine histologic wound healing following ridge preservation using cortical bone allograft,     cancellous bone allograft, or a combination of both cortical and cancellous bone allograft.     This entire protocol involves procedures that are standard care. All materials are     FDA-approved materials being used in an FDA-approved manner. The test group subjects will     have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This     test group will be compared to two active control groups - one using 100% cortical FDBA and     the other using 100% cancellous FDBA. The null hypothesis is that there will be no     significant difference in formation of new vital bone between treatment groups (primary     outcome).      Each subject will provide a single non-molar tooth site for study treatment. After tooth     extraction, the graft material will be placed and covered by a non-resorbable membrane.     Following 18-20 weeks of healing, the dental implant will be place, at which time a core of     bone will be removed from the site as part of the preparation for the implant. The core     biopsy will then be evaluated for the primary histologic outcome of % vital bone formation     and secondary histologic outcome of % residual graft material.   "
77194|NCT02275429|"     Acute consequences of ultramarathon running are still unknown as very little research has     been done on the matter. The investigators will assess the consequences on the metabolism of     runners in the ultramarathon Madmen's Diagonal on Reunion Island. Data from the literature     suggest that runners undergo loss of zinc, copper, iron, magnesium not unlike the loss of     metabolites in systemic inflammatory response syndrome. The purpose of this study is to     assess the metabolic disorders (selenium, zinc, vitamins B9 and B12) in ultramarathon     runners, during and up to 28 days after the Madmen's Diagonal which takes place on Reunion     Island every year in October.   "
77170|NCT02275754|"     This proposed 5-year Redes En Acción research study involves a mixed-methods approach that     occurs in two phases across two distinct and diverse HL communities. The RCT involves a 2 X 4     randomized repeated measures design with experimental condition (combined patient navigation     [PN] over 3 months with access to LCNS PN services[PNLCNS] vs. a PN only condition) as the     between-groups factor, and time-point (baseline/pre-randomization [T1]; post-PNLCNS [about     3-months post-T1; T2], and about 6- [T3] and about 12-months [T4] follow-up post-T2) as the     within-groups factor; total follow-up is 15 months. The investigators will compare the     effects of the PNLCNS and PN only conditions on QOL and treatment follow-up compliance in 300     (after attrition; n=100, Chicago and n=100, San Antonio) breast, colorectal and prostate HL     cancer survivors with no evidence of metastatic disease.   "
77171|NCT02275741|"     The aim of this study is to determine whether prophylactic vaccines recommended are effective     and safe in patients with multiple sclerosis(MS) under MS-specific therapy.   "
77172|NCT02275728|"     This study evaluates the action of the pelvic floor muscle training with and without EMG     Biofeddback in the treatment of stress urinary incontinence in menopausal, peri and post     menopausal women and their quality of life before and after the interventions.   "
77174|NCT02275702|"     The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small     dose of IV dexamethasone during induction anesthesia in association to pre and postoperative     intercostal nerve block, improves quality of recovery of thoracoscopic lung resection     patients.   "
77175|NCT02275689|"     This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I)     and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.      The outcome of both methods will be compared to the physical therapy treatment (groupIII)   "
77176|NCT02275676|"     Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in     IBD is often limited by chronic inflammation, but is also commonly reduced by missing     intestinal segments due to previous operations. Patients are predominantly affected by     malnutrition, which is often resembled by weight loss, specific micronutrient deficits such     as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and     zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively     limited to active phases of the disease. Causes of malnutrition can be inadequate food     intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition itself     is associated with a delayed recovery of impaired wound healing, reduced quality of life and     longer hospital stays. Therefore, observation and modification of the nutritional status     should be an integral part of therapy in IBD patients.      The primary objective of our study is to investigate the influence of the disease on the     resting energy expenditure and nutritional status during acute inflammation and clinical     remission of the disease. Secondary objectives are to assess possible nutritional     deficiencies. On the other hand it is well known that patients with IBD are at increased risk     for coronary heart disease. Therefore, another secondary focus of our observational study is     whether the composition of the HDL proteins is changed towards pro-atherogenic HDL-proteins     and whether possible changes occur in patients in clinical remission or with active disease.   "
77177|NCT02275663|"     The purpose of this phase 2 study is to test the efficacy of azacytidine given prior to     fludarabine, cytarabine, and G-CSF for the treatment of relapsed or refractory acute myeloid     leukemia.   "
77237|NCT02274870|"     Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing     total knee replacement (TKR). However the resulting motor blockade can lead to decreased     quadriceps muscle strength and delayed functional recovery.The purpose of this study is to     compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control     and functional recovery   "
77178|NCT02275650|"     The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in     the maintenance of vitamin D levels achieved during the summer in Finland. The investigators     randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard     erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels     were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not     illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the     onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.   "
77179|NCT02275637|"     The study is a prospective multicenter registry. Consecutive patients with indications of     implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be     enrolled.      The primary objective of the study is to determine the predictors of appropriate     anti-tachycardia therapy (with shock) in a non-selected population of patients implanted with     an ICD.      Secondary objectives of the study are:        -  the incidence of anti-tachycardia therapies;        -  the predictors of inappropriate therapy and onset of arrhythmia burden;        -  the adherence to the current guidelines in the Italian clinical practice;        -  the predictors of heart failure (HF) onset and response to cardiac resynchronization          therapy (CRT).   "
77180|NCT02275611|"     This study will test in individuals who have alcohol dependence (alcohol addiction) the     hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during     medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the     outpatient setting will decrease drinking.   "
77181|NCT02275598|"     The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab     vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).   "
77182|NCT02275585|"     This study evaluates the supervivence of cirrhotic patients that develop portal vein     thrombosis in comparison to cirrhotic patients that do not develop portal vein thrombosis.   "
77195|NCT02275416|"     This study, with 20 patients participating, will examine the safety and tolerability for the     ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.   "
77196|NCT02275403|"     The purpose of this study is to determine whether the addition of acupuncture to standard     treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by     patients with breast cancer or multiple myeloma, during or following treatment with     neurotoxic chemotherapy.   "
87656|NCT02138708|"     The purpose of this study is to assess the predictive performance of the pulmonary vascular     reactivity to acetylcholine, in the presence pulmonary arterial hypertension (estimated 1     year after the closure of the shunt).   "
77183|NCT02275572|"     Objective: To evaluate the clinical and economic impact of the application of an algorithm to     improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or     more medications), not institutionalized.      Design: randomized, open, multicenter and two branches of parallel intervention clinical     trial.      Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the     support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to     doctor his findings and reach a consensus and decide which recommendations will be presented     to patient. Control intervention: usual procedure.      Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP     consultations, hospital emergency department and hospital admissions for acute illness, c)     pharmaceutical expenditure, d) restart medication e) complications underlying diseases.     Follow-up control at 1 month (security) and at 3, 6 and 12 months.   "
77184|NCT02275559|"     Asthma is one of the four most common adult chronic disorders. Supporting asthma patients in     improving their asthma control and symptoms as well as their quality of life are important     goals in clinical management. This study will test the effect of a widely-available     mindfulness training program in improving asthma control and symptoms and quality of life     among patients with asthma, and explore the relationship between asthma control and a number     of factors, including how well patients perceive their respiratory symptoms.   "
77185|NCT02275546|"     The purpose of the study is to assess the performance and safe use of the vaginal ring     applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in     healthy women   "
77186|NCT02275533|"     This randomized phase II trial studies how well nivolumab works in eliminating any remaining     cancer cells and preventing cancer from returning in patients with acute myeloid leukemia     that had a decrease in or disappearance of signs and symptoms of cancer after receiving     chemotherapy. Monoclonal antibodies, such as nivolumab, may block cancer growth in different     ways by targeting certain cells.   "
77187|NCT02275520|"     The investigators will compare the success rates and time to successful IO access during     simulated adult resuscitation.   "
77188|NCT02275507|"     The purpose of this study is to determine the normal hemoglobin curve during cesarean     delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to     detect life-threatening bleeding earlier.   "
77189|NCT02275494|"     Leg length discrepancy (LLD) is a complication of THA and may result in patient     dissatisfaction, gait disorder, greater trochanter pain, low back pain. In the literature,     LLD is reported to vary widely among studies e.g. 6 to 35 mm. However, the threshold at which     a LLD is clinically important is still a matter of debate. The aim of this study was to     determine the influence of non-corrected LLD after THA on patients' reported hip function and     quality of life. This prospective cohort study was conducted at Sundsvall Teaching Hospital     in Sweden after it was approved by the regional ethics committee at Umeå University (No.     07-052M and No. 12-287-32M). Between September 2010 and April 2013, all patients with     unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.     Informed consent was obtained from all patients. Patients with secondary OA, previous spinal,     pelvic, or lower limb injuries or fractures were excluded.      The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis     (WOMAC) Index that measures functional outcome (ref). The secondary outcome measure was the     EQ-5D and visual analogue scale (VAS) scale. Patients were assessed preoperatively and at     follow-up at 1 year postoperatively. The posterolateral approach was used in all operations.     LLD was measured on the postoperative x-rays. patients were divided into three groups:     shortening group where the operated leg was more than 5mm shorter compared with the     contralateral side, the restoration control group where the operated leg was within 5mm     shortening and 9mm lengthening compared with the contralateral side, and the lengthening     group where the operated leg became more than 9mm longer compared with the contralateral     side.   "
77190|NCT02275481|"     This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD     subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet     the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate     inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg     once daily (QD), each given for 90 days.   "
81852|NCT02214602|"     The aim of the study is to test the value of immediate post-operative intravesical     instillation of epirubicin in patients with intermediate and high risk non muscle invasive     bladder cancer (NMIBC).   "
77192|NCT02275455|"     The worldwide prevalence of autism is constantly increasing. People with autisms have     difficulties in communication and social interaction resulting from atypical perceptual and     information processing, leading to the accumulation of anxiety. Extreme overloading     experienced internally may not be visible externally. Identifying stressful situations at an     early stage may avoid socially problematic behavior from occurring, such as self-injurious     behavior. Activation of the autonomous nervous system (ANS) is involved in the response to     anxiety, which can be measured through heart rate variability and skin conductance with the     use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis     of signal perception and reaction is necessary, mainly for the non-communicative individuals     with autism.   "
77193|NCT02275442|"     The link between precarious situations and health conditions are more described in previous     study. Precarious situations are more frequent and complex especially in rural areas. There     are recognized like a risk factor of complications during pregnancy and delivery. It's     necessary to describe antenatal cares for rural women in precarious situations to prevent     those situations, to understand their difficulties in order to reduce inequalities and health     spending.      The aim of the PRUGNANCY study is to understand the difficulties of rural parturient women     and the strategies developed to overcome them. Recognized earlier precarious situations and     valorized General Practitioners and restore them to the follow-up or parturient women.   "
77242|NCT02274805|"     The purpose of the study is to gather tissue (from the neck region), specimens (blood and     urine) and medical record data from many patients and store them in one place so that     scientists have the information they need to conduct research and learn about new ways to     predict, identify and treat illness, specifically those related to obesity and diabetes.   "
77243|NCT02274792|"     The purpose of this study is to learn more about the immune response to etanercept produced     using a modified process in patients with plaque psoriasis.   "
77197|NCT02275390|"     The study aims to test the effectiveness of a nurse-led psycho-education program based on     motivational interviewing technique for Chinese patients with first-onset mental illness over     a 12-month follow-up. A randomized controlled trial will be conducted with 180 Chinese     patients with schizophrenia newly referred to one outpatient clinic in Hong Kong. They will     be randomly assigned to either the eight-session nurse-led psycho-education program or usual     psychiatric outpatient care (both n=90). The patients' general and mental health, illness     insight, self-efficacy, services utilization, and hospitalization rates were measured at     recruitment and one week, six months and 12 months post-intervention.   "
77198|NCT02275377|"     This research aims to evaluate the effects of inspiratory muscle training (IMT) on blood     pressure, in inspiratory muscle mechanoreflex, autonomic cardiovascular control in subjects     with hypertension.   "
77199|NCT02275364|"     The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo     strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the     strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis     techniques derived from physiological data collected during scanning.   "
77200|NCT02275351|"     The purpose of this study is to characterize the safety, tolerability, and efficacy of     topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with     Androgenetic Alopecia (AGA).   "
77201|NCT02275338|"     To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to     inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to     assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the     recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a     nasogastric tube.   "
77202|NCT02275325|"     Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular     nerve, which slowly grows within the internal auditory canal and then into the     cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive     alteration of vestibular function allows the gradual implementation of central adaptive     mechanisms called vestibular compensation. The total unilateral vestibular deafferentation     induced by the surgical tumour removal suddenly leads to a decompensation of this previously     compensated situation, which explains why most patients report severe vertigo immediately     after surgery and which is responsible for perturbations of the postural control     (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested     that preoperative and regular physical activity would limit the adverse effects of surgical     removal on balance control. Also, patients benefited faster and better from the postoperative     vestibular rehabilitation.      Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could     help to limit postoperative balance disorders and promote postoperative balance compensation.     This could lead to a decrease in the duration and cost of the postoperative management and     faster improvement of quality of life.   "
77203|NCT02275312|"     The objective of this study is to evaluate the effectiveness of BoNT-A on functional     improvement in patients with post-stroke upper and/or lower limb spasticity in the early     stage of spasticity development, according to routine clinical practice.   "
77204|NCT02275299|"     This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate     Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).   "
77233|NCT02274922|"     For a long time, culture was the only way to detect Campylobacter. It appears that rapid     immunochromatographic tests (ICT) have detected more positive cases compared to culture,     ELISA and molecular tests. The aim of our study is to evaluate the specificity of the ICT     which are really interesting tools to use since they allow a diagnosis in about 15 min, in     comparison to different methods of detection even serology.   "
81853|NCT02214589|"     A. Specific Aims Premature infants admitted to the neonatal intensive care unit (NICU)     require up to several hundred procedures during their hospitalization. Many of these are     tissue-damaging procedures (TDPs) known to cause pain [1]. Through funding from NINR, the     investigators found that TDPs not only caused pain but also increased markers of ATP     degradation and oxidative stress[2[. The TDP was tape removal, a commonly performed procedure     in the NICU2.      Based on this finding, the investigators sought to determine if interventions that relieve     pain also reduce biochemical markers of ATP degradation and oxidative stress. The     investigators first examined the effect of oral sucrose, a commonly used intervention, when     given before a heel lance. The investigators chose heel lance because it is the most     predominant painful procedure in the NICU, as shown in 29 different clinical trials[3]. The     investigators hypothesized that since oral sucrose is documented to significantly reduce pain     scores, then administration of this analgesic will also decrease markers of ATP degradation     and oxidative stress. However,the investigators observed the opposite effect. Although a     single dose of oral sucrose reduced behavioral markers of pain, it significantly increased     biochemical markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress     (allantoin) over time[4]. More importantly, the effect of oral sucrose on breakdown markers     of ATP were enhanced and were significantly higher in neonates that were intubated or were     receiving more than 30% FiO25. These findings lead to the question: If oral sucrose does not     effectively reduce the biochemical effects of procedural pain, what intervention or groups of     intervention will decrease both behavioral markers of procedural pain and reduce ATP     utilization and oxidative stress in premature neonates? For this RO1 renewal, the     investigators propose to test the individual and additive effects of two commonly used     interventions for procedural pain. These interventions are (a) administration of 30% oral     glucose and non-nutritive sucking (NNS) (b) facilitated tucking and NNS c) administration of     30% oral glucose, facilitated tucking and NNS. Administration of 30% oral glucose was     documented to decreased procedural pain scores[6-9] without the potential adverse effects of     fructose, a key ingredient of sucrose[10-11]. Facilitated tucking is the gentle positioning     of preterm infants with arms and legs in a flexed, midline position close to the body, while     either in a side-lying or prone position[12]. Because tachycardia often accompanies pain, a     documented benefit of facilitated tucking is stabilization of heart rate and reduction of     motor activity (flailing)[12-13]. Non-nutritive sucking refers to the provision of a     weight-appropriate pacifier[14]. The painful procedure will be a clinically required heel     lance, which refers to the puncture of a newborn's heel for blood glucose using a specially     designed lancet. Our general hypothesis is that commonly used clinical interventions known to     reduce procedural pain alter biochemical markers of ATP degradation, oxidative stress and     cell injury.      Specific Aim 1 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking     and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease procedural     pain.      • Pain will be quantified using a validated pain scoring tool, the Premature Infant Pain     Profile (PIPP). Individual and additive effect of interventions will be determined.      Specific Aim 2 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking     and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease biochemical     markers of ATP degradation, oxidative stress and oxidative cell injury.        -  Products of ATP breakdown in plasma—hypoxanthine (Hx), xanthine (Xa), and uric acid          (UA)—will be measured using high performance liquid chromatography.        -  Oxidative stress will be quantified by measuring plasma levels of allantoin using mass          spectrometry.        -  Cell injury will be quantified by measuring plasma levels of F2 isoprostane using          liquid-chromatography/mass spectrometry.   "
77205|NCT02275286|"     Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response     measure in two cohorts of patients:      Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically     recommended metastasectomy of limited to lung metastases soft tissue sarcoma.      Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Phase I: escalating     dose of 1.3 or 1.5 mg/m2. Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction)     Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction) A translational substudy is     developed to analyse different biomarkers predictive value.   "
77206|NCT02275273|"     The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics     of adnexal masses with their anatomopathological characteristics.   "
77207|NCT02275260|"     The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to     compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new     subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data     from the literature.   "
77208|NCT02275247|"     To investigate whether stellate ganglion block is helpful to brain protection during cranial     aneurysm surgery   "
77209|NCT02275234|"     The purpose of this study is to investigate whether simple psychological interventions can be     implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the     psychological wellbeing of survivors of cardiac arrest during their recovery.   "
77210|NCT02275221|"     Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV     infected patients in a number of different immunological assays, the investigators hope to     identify any changes in the number and function of these immune cells and to investigate how     these changes contribute to viral persistence and disease progression.   "
77211|NCT02275208|"     This study is a prospective, multi-center, single-arm study evaluating the SIPS procedure.     Subjects who meet the eligibility criteria will be considered for study participation and     will be followed through 12 months.   "
77212|NCT02275195|"     Through bio-sampling this study investigates the relationship between the frequency and     function of the cells of a patients immune system and how these change and impact on the     outcome of alcoholic hepatitis. the investigators will examine the role of different cells of     the immune system and how they may determine the outcome of this condition. The investigators     will also look at how established treatment strategies impact on the frequency and function     of these cell subsets.   "
77213|NCT02275182|"     Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can     lead to a reduced ability and seriously affect the quality of life of patients, increase     personal and social burden, POCD may also increase mortality.POCD can occur at any age, but     the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are     more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by     preoperative cognitive function and psychological scales postoperative assessment, the main     recommendation of the agreed test methods include, Rey auditory verbal test, the connection     test, digit span test. In this study, preoperative mini-mental state examination (MMSE)     screening, comprehensive neurological function during hospitalization for memory, attention,     executive function and exercise capacity test, and telephone follow-up after discharge Scale     Revised (TICS-M) test.      Few study showed that dexmedetomidine may improve cognitive function in young patients others     show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These     results conflict and it is necessary to carry out large-scale, multi-center, randomized,     controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or     not for elderly patients.   "
77214|NCT02275169|"     Aim of the study is to evaluate the effect of highly purified human follicle-stimulating     hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from     infertile male patients with non-obstructive azoospermia of unknown origin.   "
77215|NCT02275156|"     The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after     a single 140 mg subcutaneous (SC) dose in adults with normal renal function or severe renal     impairment or end-stage renal disease (ESRD) receiving hemodialysis.   "
77216|NCT02275143|"     Currently patients with certain cancer usually have routine follow up (Computed Tomography of     Thorax, Abdomen and Pelvis) CT TAP scans to see response to treatment or relapse. The study     proposal allows the evaluation of the coronary arteries by modifying the current CT TAP     technique without significant additional procedures, intravenous contrast or radiation - i.e.     an opportunistic Computed Tomography Coronary Angiogram (CTCA) without any penalty. The     question is does performing Computed Tomography (CT) of the thorax in such a way confer     important additional information about cardiac risk? At the same time the investigators need     to ensure that doing scan as per CTCA protocol produces equivalent image quality to evaluate     other structures in the chest. A recent small retrospective study has using a similar     technique suggests that it may in fact improve image quality due to less cardiac related     motion artefact.   "
77217|NCT02275130|"     The voice is an indispensable source of human communication. Current time puts high demands     on the quality of voice in most professions. Organic or functional changes of vocal cords     associated with their insufficiency lead to a deterioration of voice quality, voice fatigue,     hoarseness or breathing difficulties. This has adverse psychological, social and economic     consequences for the patient, the employer and its surroundings. The injection techniques can     be performed under general and local anaesthesia. The defined injectable substance is     inserted directly in the vocal cords, which increases its volume and results in an almost     immediate improvement of the voice quality. For injection can be used various materials, e.g.     autologous fat, calcium hydroxyapatite, silicone, and others. Injection techniques are less     invasive, associated with less perioperative morbidity. Operation can be also performed under     local anaesthesia in selected patients, therefore is preferred for patients with multiple     comorbidities and risk of general anaesthesia.   "
77218|NCT02275117|"     The purpose of this study is to assess ALD403 in the prevention of migraine headache in     chronic migraineurs.   "
77234|NCT02274909|"     To compare the influence of a training program with Pilates and PNF methods to elderly women     on the strength gains and motor control during voluntary contractions   "
77235|NCT02274896|"     The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that     is impregnated with a cocktail of three well known anti-microbials   "
77219|NCT02275104|"     MIGAT will develop and transfer software tools to assist ablation therapy of cardiac     arrhythmias. The scientific background and objectives of MIGAT differ between atrial and     ventricular arrhythmias, because the knowledge on structure-function relationships and the     definition of ablation targets are different.      Hypothesis: The combination of body surface mapping and imaging will enable a comprehensive     non-invasive assessment of cardiac arrhythmia mechanisms and localization, myocardial     structural substrate, and cardiac anatomy, all of which should be of value to better define     targets for ablation therapy. No software solution is currently available for multimodal data     processing, fusion, and integration in 3-dimensional mapping systems to assist ablation.     Because such a development requires a trans-disciplinary approach (cardiac electrophysiology,     imaging, computer sciences), it is likely to emerge from an academic initiative.      Objectives: MIGAT will gather resources from the Liryc Institute (L'Institut de Rythmologie     et Modélisation Cardiaque), the Inria (Institut National de Recherche en Informatique et en     Automatique) and the University Hospital of Bordeaux to develop a computer-based solution     with high expected impact on the daily management of cardiac electrical disorders. The     research program will benefit from the MUSIC (Magnetom Avanto, Siemens, Erlangen, Germany)     equipment recently funded as part of the Investissement d'Avenir program, and combining     state-of-the-art electrophysiology and magnetic resonance imaging technology. MIGAT will     involve software engineers, computer science researchers, cardiologists, radiologists and     clinical research personnel with the following objectives:        -  Development of a multimodal data processing software to assist cardiac ablation        -  Optimization and Validation of the software in terms of user experience        -  Optimization and Validation of the software in terms of clinical performance        -  Optimization of software quality compatible with subsequent device certification and          randomized-controlled evaluation   "
77220|NCT02275091|"     Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease     and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients     with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before     age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD     so that interventions to prevent heart disease and stroke can be undertaken.   "
77262|NCT02274545|"     H7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China that     affected many older adults. This study will evaluate the safety of and immune response to a     live attenuated H7N9 vaccine in adults 50 to 70 years old.   "
77263|NCT02274532|"     A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a     prosthetic terminal device will enhance the performance of people with limb loss in a wider     range of daily living tasks than allowed by today's commercially available prosthetic hands,     and will exceed established benchmarks for activities of daily living (ADL).   "
77264|NCT02274519|"     Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of     movements with meditation, improve quality of life in those afflicted with multiple myeloma     undergoing autologous stem cell transplantation?   "
77221|NCT02275078|"     The purpose of this project is to conduct a pilot study evaluating the feasibility and     potential benefits of a phone assessment/reporting system (tele-system) in addition to a     written action plan and nurse case manager support to improve patients' adherence to COPD     treatment in those at risk for exacerbations.      Primary objective: explore the potential benefits with respect to patient's adherence, i.e.,     prompt use of the antibiotic and/or prednisone in the event of an exacerbation, increased     adherence to maintenance medication; to increase patient's self-efficacy in self-managing     their disease; and to use more efficiently program resources, i.e., the case-manager.      Secondary objectives:      To assess the proportion of patients who effectively self manage exacerbations by using their     COPD Action Plan      To assess self management of COPD patients with respect to the increased adherence to regular     respiratory medication, (SmartInhaler electronic monitoring);      To assess increased self-efficacy in COPD patients identifying and managing exacerbations     (baseline vs after 12 months);      To assess symptoms recovery, health status improvement, and prevention of ER visits and     hospital admissions for COPD exacerbations.      To assess the efficiency in using program resources,      To evaluate the feasibility of this treatment approach and to provide pilot data (needed for     a larger multi-centre clinical trial;      To evaluate the feasibility and need of assessment during and after exacerbation onset,     health-related quality of life and physical activity;      To evaluate the safety of this approach; this is in terms of the delay in starting prednisone     and an unfavourable outcome (ER visits and/or hospitalization).   "
77222|NCT02275065|"     This study will investigate the short-term antiviral potency, safety, plasma pharmacokinetics     (PK), and the PK/pharmacodynamic (PD) relationship (the dose-response relationship) of     GS-9883 at multiple doses in antiretroviral (ART) treatment-naive adult subjects and subjects     who are ART-experienced but are currently off of ART therapy. Up to 32 participants will be     enrolled in the study.   "
77223|NCT02275052|"     This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete block     design cross-over study.      The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on EET     as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionally, the     effect of UMEC/VI compared to placebo on lung function and lung volumes in COPD patients will     be characterized.      Approximately 298 participants will be screened and, assuming 35% of these will not be     eligible for randomization; approximately 194 participants will be randomized.      Eligible participants will be randomized 1:1 to one of 2 treatment sequences. In sequence 1     participants will receive UMEC/VI 62.5/25 mcg in Treatment Period 1 and placebo in Treatment     Period 2. In sequence 2 participants will receive placebo in Treatment Period 1 and UMEC/VI     62.5/25 mcg in Treatment Period 2. Treatments will be delivered once-daily via a dry powder     inhaler (DPI). Each treatment period will be for 12 weeks and will be separated by a wash out     period of 12-17 days. The total duration of patient participation, including the Follow-Up     will be approximately 30 weeks. All participants will be provided with albuterol for use on     an as needed (prn) basis throughout the run-in, washout and study treatment periods while     on investigational product.   "
77224|NCT02275039|"     This phase I trial studies the side effects and recommended dose of the combination of p53MVA     vaccine (modified vaccinia virus ankara vaccine expressing tumor protein p53 [p53]) and     gemcitabine hydrochloride in treating patients with ovarian epithelial cancer that has come     back. Vaccines made from inserting a laboratory-treated gene into a person's tumor cells may     help the body build an effective immune response to kill tumor cells that express p53. Drugs     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving modified vaccinia virus ankara vaccine expressing p53     together with gemcitabine hydrochloride may work better in treating patients with ovarian     epithelial cancer.   "
77225|NCT02275026|"     The purpose of this study is to understand how elderly individuals regain their cognitive     skills following general anesthesia. The investigators will compare an age stratified group     of volunteers who will be evaluated with a series of cognitive tests and a functional MRI.     The participants will then be administered general anesthesia for two hours. The     investigators will then assess the participants using state of the art tools to determine     when participants return to their cognitive baseline.   "
77226|NCT02275013|"     To assess the effects on outcome of levosimendan with respect to timing of its administration     on the postoperative course of high-risk cardiac surgery patients in a retrospective     observational study.   "
77227|NCT02275000|"     The aim of this study is to develop and assess the feasibility of a physiotherapy     intervention for people with functional motor symptoms (also known as psychogenic     neurological symptoms and conversion disorder). Participants will be randomised to receive     the intervention or a treatment as usual control.   "
77239|NCT02274844|"     Medication adherence is especially critical in regions like rural Alabama, where residents     have among the worst health outcomes in the US. This project was designed in collaboration     with our community member partners and builds on a 5-year partnership of community-engaged     research on diabetes peer coaching interventions and our experience with peer storytelling.     The investigators will test the hypothesis that an intervention designed within the Corbin     and Strauss framework can improve adherence and health outcomes compared to usual care.   "
77240|NCT02274831|"     The purpose of this study is to see if patients who receive an email reinforcing their     discharge instructions after being discharged from the emergency department will have an     affect on follow-up care with their primary physician.   "
77241|NCT02274818|"     The investigators are conducting a cluster randomized trial in a sample of 63 internal     medicine (IM) training programs that are randomly assigned to either the current duty hour     standards or less restricted flexible duty hour standards.      The trial includes a main protocol in which all randomized IM programs participate and two     substudies. Time and Motion and Sleep and Alertness, each conducted at a subset of IM     programs and focusing on more detailed data collection at the intern level.      The main protocol will examine patient safety and costs as well as quality of education. The     Time and Motion substudy examines additional educational outcomes. The Sleep and     Alertness substudy examines intern sleep time and alertness.   "
77244|NCT02274779|"     There is an increasing number of reports describing the existence of a proportion of prostate     cancer patients who present with a reduced number of metastases (<5 lesions) at relapse. This     oligometastatic status has also been recognized in other tumor types such as melanoma, soft     tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these     malignancies in that a more radical treatment such as surgical resection has been employed.     Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as     choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease     after biochemical treatment failure in prostate cancer. An aggressive treatment combining     androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic     lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a     treatment strategy may hypothetically succeed to prolong the failure-free interval between     two consecutive ADT courses, or even cure selected patients with limited metastatic burden.     In this study the investigators plan to assess biochemical or clinical relapse-free survival     at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose     conformal Radiation Therapy and LH-RH agonists.   "
77245|NCT02274766|"     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group     study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an     investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of     levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel     pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the     early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in     the evening, potentially reducing the negative impact of amantadine on sleep. This     pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER     formulation than can be tolerated with an immediate-release formulation. The once-nightly     dosing regimen may also provide enhanced convenience and compliance.      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly     reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.   "
77246|NCT02274753|"     Colorectal cancers are the leading cancers for both sexes combined. They represent 15-20% of     all cancers. This cancer has a severe prognosis, the survival rate at 5 years is around 55%     and in France it is estimated, all colorectal cancers are responsible for an annual mortality     of 15,000 patients. The prognosis of colon cancer knows no significant improvement.      The treatment of colon cancer is surgical. It is intended for removal of colonic segment     bearing the tumor with margins of healthy colon. The therapeutic attitude following the     surgery is essentially driven by histopathology of the tumor. Adjuvant chemotherapy for all     patients with localized stage II provides no benefit because the effectiveness of     chemotherapy is limited and vulnerable to systemic toxicity. However, nearly 30% of patients     with stage II disease will have a recurrence / metastasis. These patients could benefit from     adjuvant chemotherapy.      Intense research efforts have been made to identify markers predictive of relapse. Over     thirty biological markers (eg. Mutations, deletions, chromosomal instability, ...) were     highlighted. None of them has so far sufficient prognostic value (independent of TNM) to     justify routine application in clinical practice in order to adapt the treatment of patients.      The identification of new prognostic markers is a major issue for colorectal cancer. We     showed that the intratumoral density memory T lymphocytes (CD45RO) and cytotoxic (CD8)     strongly influenced the clinical outcome of patients. We have developed and validated a     immunoscore technique intratumoral immune quantification and creates a platform to     facilitate the clinical immuno transfer.      We are currently conducting a large international retrospective study (22 centers,> 9000     patients) with promotion of cancer immunotherapy Company (SITC) to validate the method     immunoscore. At the same time, we are conducting a prospective multicenter study ImmuCol     (National PHRC) to validate the prognostic value of immunoscore in colorectal cancer stage     I-IV. The goal of inclusion has been achieved, as 420 patients were included for 18 months.     Clinical follow-up will be 3 years after surgery.      The program ImmuCol2 research takes advantage of the ImmuCol study to extend the     investigation beyond the immunoscore to define the combination of interest, prognostic and     theranostic parameters at diagnosis and during the clinical course patients with an objective     of personalized medicine.   "
77247|NCT02274740|"     Primary Objective:      To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in     particular, the effects on plasma changes in triglycerides.      Secondary Objectives:      The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48;     free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL)     oxidation.      The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent     diabetes mellitus (NIDDM) and obesity.      The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of     lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.   "
77314|NCT02273869|"     Our infertility unit has started a clinic for women with rheumatological diseases. those     women are prone to infertility problems and it might be due to their illness or cytotoxic     treatment . In our study we are going to observe the effect of their disease on ovarian     reserve. we will assess it by using intravaginal sonography and blood test such as hormonal     profile and anti-mullerian hormone (AMH).   "
77248|NCT02274727|"     The three-year cumulative risk of a recurrent stroke, dependent on aetiology, is up to 25 per     cent. At present, preventing recurrence relies on a broad approach to reduce risk factors     associated with atherosclerosis, heart disease and metabolic disorders. However, more     specific interventions, such as anticoagulation and surgery or stenting, need aetiologic     information. BIOSIGNAL aims to determine where the most promising biomarkers can help     identify stroke aetiology and also predict recurrent stroke. In addition, the insights gained     into the processes underlying different stroke subtypes may lead to more targeted diagnostic     tools.   "
77249|NCT02274714|"     This case-control study will screen for dysmenorrhea and assess severity of menstrual     symptoms in menstruating women with CD and UC compared with healthy age-matched controls. IBD     activity will be characterized using previously validated clinical disease activity indices.     General and health-related quality of life will be assessed using validated measures.   "
77250|NCT02274701|"     This study evaluates the impact of holistic needs assessment (HNA) on patient/clinician     communication in outpatient cancer care. Half of the participants will complete a HNA prior     to their clinical consultation. They will then take it into the consultation and it will     inform a discussion around any identified areas of need. Half of the participants will be in     the control group meaning there will be no additional intervention they will receive care as     normal. The consultations will be audio-recorded. The patient will complete two outcome     measures following the consultation.   "
77285|NCT02274246|"     The purpose of this study is to validate the technique for the detection of left atrial     fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained     with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of     healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.   "
77251|NCT02274688|"     The nation's trauma care system, which includes trauma center hospitals & emergency     departments, is where over 30 million Americans receive care after traumatic injuries each     year. Injury victims are diverse patients who suffer from complications of the initial injury     as well as from multiple complex medical & mental health conditions. Currently, high-quality     patient-centered care is not the standard of care throughout US trauma care systems. Injured     trauma survivors treated in trauma care systems frequently receive fragmented care that is     not coordinated across hospital, emergency department, outpatient, & community settings.     Post-injury care is frequently not individualized to integrate the patient's most pressing     post-traumatic concerns & preferences into medical decision making. The investigators, as a     group of front-line trauma center providers, patients, researchers & policy makers, have been     working together for over a decade to integrate patient-centered care into US trauma care     systems. The investigators began this work by asking groups of injured patients the key     patient-centered question: Of everything that has happened to you since your injury, what     concerns you the most? The investigators developed scientifically sound assessment tools     that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the     investigators convened an American College of Surgeons' policy summit that addressed mental     health & patient-centered care integration across US trauma care systems. As part of this     policy summit, patient members of our team presented their experiences of traumatic injury &     recovery. While giving injured patients a voice at the summit, these narratives did not     move surgical policy makers to develop mandates or guidelines for patient-centered care. In     contrast, presentations that included information from randomized comparative effectiveness     trials & standardized outcome assessments convinced surgical policy makers to develop US     trauma care system policy mandates & best practice guidelines for post-traumatic stress     disorder & alcohol use problems. Our team now realizes that in order to optimally integrate     patient-centered care into US trauma care systems, the investigators must use the best     scientific methods that capture the highest-quality data. This PCORI proposal aims to     demonstrate that a patient-centered care management treatment that addresses patient's     post-injury concerns & integrates patient concerns & preferences into medical decision     making, while also coordinating care, can improve outcomes of great importance to patients &     their caregivers, front-line providers & policy makers. This proposal directly addresses two     PCORI patient-centered research questions: After a traumatic injury, what can I do to     improve the outcomes that are most important to me? & How can front-line providers working     in trauma care systems help me make the best decisions about my post-injury health & health     care?   "
77252|NCT02274675|"     A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of     including robotic therapy into the daily rehabilitation program.   "
77253|NCT02274662|"     The primary purpose is to provide access of thymus tissue transplantation to patients who     have immunodeficiency, hematologic malignancies, or severe autoimmune disease related to poor     thymic function. With no thymus function, bone marrow stem cells do not develop into T cells,     which fight infection.      Eligible participants undergo thymus transplantation and biopsy. Immune suppression may be     given depending on the immune status and clinical condition of the participant. Immune     function testing is continued for one year post-transplantation.   "
77254|NCT02274649|"     The research will examine the effects of enhanced peer mentor interactions on facilitating a     successful transition to community living following traumatic spinal cord injury.     Participants in the research will be assigned to either (1) the control group that will     receive traditional peer mentor types of interactions or (2) to the intervention group that     will receive an enhanced peer mentor program called the One-on-One Initiative. Assignment to     one of these two groups will occur randomly on admission to Shepherd Center; the only     stratifying criteria is injury level - C6 and above vs. C7 and below.   "
77255|NCT02274636|"     This research study is a randomized, controlled study developed to test how well a dry mouth     product that contains xylitol affects some of the symptoms of gastroesophageal reflux disease     (GERD. Individuals who experience symptoms of gastro esophageal reflux disease (GERD) and who     are accepted into the study will be asked to report on the frequency and severity of several     symptoms specific to the condition that occur during sleep. The study is composed of two     phases:      Phase one involves collection of baseline information for two weeks. Phase two is the     intervention phase of the study. In this phase of the study, each subject will be randomly     assigned (like flipping a coin) to use either the product of interest or a different dry     mouth product for two weeks.   "
77256|NCT02274623|"     This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases     arising from either breast or prostate cancer, who are taking anti-resorptive therapy.   "
77257|NCT02274610|"     Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC     and Cmax   "
77258|NCT02274597|"     The aim of this study is to assess the impact of different environmental factors on the     ability for a thermistor-based epitympanic thermometer to accurately read the temperature of     a normothermic individual and thereby estimate their feasibility and reliability in the     austere pre-hospital setting.   "
77259|NCT02274584|"     Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster of     differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin     lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive     target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will     evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism     (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.   "
77298|NCT02274077|"     The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal     wall reconstruction population using an intraoperative local anesthetic infusion. A     prospective randomized double blind study of patients undergoing component separation will be     performed in order to assess the following outcomes:        1. Length of Stay (LOS)        2. Return of bowel function        3. Narcotic pain medication requirements        4. Nausea and emesis        5. Pain scores   "
77260|NCT02274571|"     The purpose of this study is to find out if a novel drug approved by the Food and Drug     Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal     dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by     decreasing body fat especially in your liver.      DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a     mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is     FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help     manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of     postmenopausal women, the use of estrogens alone can increase the risk of developing cancer     of the uterus. So estrogens have been traditionally paired with a progestin to decrease the     risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to     cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place     of a progestin to help protect the uterus against thickening of the uterus that may result     from estrogens alone.      In this study, you will get either DUAVEE™ or the placebo (a dummy pill that may look like     medicine but contains no active medication) first and then switch to the other pill.   "
77261|NCT02274558|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854     administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.   "
77265|NCT02274506|"     The goal of this clinical research study is to learn if researchers can successfully and     safely give patients who have had a stem cell transplant an infusion of white blood cells     (called T-cells) that have been collected from an unrelated person, and that have been     genetically changed. The process of changing the DNA (genetic material) of these T-cells is     called gene transfer. The gene transfer involves drawing blood from an unrelated donor,     separating out T cells using a machine, changing the cells' DNA in the laboratory, and     returning the genetically changed cells back to the body. T-cells are a type of white blood     cell that fight infection. The type of gene transfer being used in this study is designed to     help your T-cells to better fight cancer by targeting a chemical marker that is found on     certain cancer cells.      Researchers want to learn if these genetically-changed T-cells can help to control B-cell     leukemia or lymphoma after a stem cell transplant.      Researchers want to find out the highest tolerable dose of these T-cells that can be given to     patients with relapsed leukemia or lymphoma.   "
77266|NCT02274493|"     The goal of this clinical research study is to learn more about the safety and feasibility of     using the Da Vinci Robotic Surgical system in procedures that harvest the latissimus dorsi     muscle (a back muscle below your shoulder) for reconstructive procedures.   "
77267|NCT02274480|"     The goal of this study is to see if a special type of heart scan called a diffusion weighted     magnetic resonance imaging (DW-MRI) that uses extra measurements, can be used to find early     signs of heart damage from chemotherapy.   "
77268|NCT02274467|"     Lumbar epidural analgesia is commonly used for labor pain relief due to its effectiveness and     safety. Despite its very high success rate, the epidural technique remains a rather blind     technique and failures continue to occur. The correct placement of an epidural catheter,     however, remains a clinical problem, since there is no imaging technique that could be used     at the bedside to determine the exact positioning of the catheter. The technique of a     trans-catheter electric stimulation test (TCEST) has been successfully used to detect the     proper epidural catheter location for pediatric, post-operative and laboring obstetric     patients. The response to the TCEST with the uniport (single hole) epidural catheters has     been well described. There is a growing body of evidence that multiport epidural catheters     provide an advantage to uniport catheters, since additional ports likely allow for an     enhanced distribution of the local anesthetic solution. This was shown to result in a lower     incidence of inadequate analgesia, including unilateral sensory blockade and missed sensory     segments. The characteristics of the TCEST response using a multiport catheter remain to be     determined. The aim of this study is to compare the response patterns to the TCEST using a     single port versus multiport wire reinforced epidural catheters. The hypothesis of this study     is that the incidence of a bilateral response to the TCEST will be higher in the multiport     catheter as compared to the uniport catheter.   "
77278|NCT02274337|"     AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR)     mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small     cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular     mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively     suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal     transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last block     the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate Capsules has     three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress the EGFR mutant     tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient suppress the EGFR     T790M drug-resistant mutation tumor cell.   "
77279|NCT02274324|"     To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in     patients with PD treated with Duodopa®. This is in search for an optimal diet that will     accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and     thus improve motor function and quality of life.   "
77280|NCT02274311|"     To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and     testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy     and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone     receptor antagonist)   "
77269|NCT02274454|"     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide     and is caused most commonly by poor uterine muscle tone after delivery. The first line agent     used in the prevention and treatment of PPH is oxytocin, which acts by binding with the     oxytocin receptor (OTR) found on myometrial cells to cause uterine contraction. It does this     by increasing levels of calcium within the myometrial cell, which promotes contraction. Women     who require augmentation of labor with intravenous oxytocin because of inadequate labor     progression have been shown to be at increased risk of PPH. In-vitro human myometrial models     have shown that following prolonged exposure to oxytocin there is desensitization of the     myometrium resulting in a significant reduction in contractility upon delivery of further     oxytocin.      Optimal levels of calcium are very important for contraction of the uterine muscle. Too     little calcium results in a reduced contraction. Too much calcium may result in either     stronger contractions, or even possibly relaxation of the muscle and therefore a reduced     contraction. The investigators currently do not know the effects of calcium on the     desensitized uterine muscle.      The investigators hypothesize that myometrial contractility following desensitization of the     myometrium would be reduced in myometrial samples exposed to low calcium, when compared to     normal calcium or high calcium exposure. These results will help in establishing whether     myometrial contraction can be augmented by increasing calcium levels within the body, or by     optimizing normal physiological calcium levels, in the setting of a augmented prolonged     labor, which is at higher risk of poor uterine contraction and PPH.   "
77286|NCT02274233|"     The purpose of this study is to assess safety and amount of the study drug in the blood after     increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.   "
77287|NCT02274220|"     The purpose of this randomized trial is to clarify the role of enteral nutrition (EN) on the     relationship between cardiopulmonary bypass-induced inflammation and insulin resistance by     investigating the effects of two different feeding strategies in infants following cardiac     surgery. The study's primary objective is to determine if early and higher volume feeding     modifies the relationship between the severity of postoperative systemic inflammation and     insulin resistance.   "
77270|NCT02274441|"     There is no large-scale data in France or internationally, on the quality of care in     gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or     on determinants of these delays or misdiagnosis. The creation of a sentinel network for     gynecological emergencies could help quantify these links and test strategies to avoid the     worst effects by implementing simple diagnostic tools from clinical research.      The network will be designed to promote research in women's health and the emergency     reception by focusing on:      (i) Assessment of the quality and organization of care and professional practice for the     management of gynecological emergencies.      (ii) The study of severe morbidity and its determinants (iii) comparison of organizational     practices and health outcomes of women over time within the same department or between     services having substantially the same recruitment (iv) Comparison of organization systems     gynecological emergencies departement between different high resource francophone countries     (France, Switzerland, Belgium).      (v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic     derived from clinical research.   "
77271|NCT02274428|"     Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical     cord blood derived mesenchymal stem cells) in the premature infants with intraventricular     hemorrhage (IVH, grade 3-4)   "
77272|NCT02274415|"     Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle     cells disease.      The 23-valent pneumococcal polysaccharide vaccine (PSV) is supposed to be poorly immunogenic     in these patients. We want to evaluate whether a prime with a 13-valent pneumococcal     conjugate vaccine (PCV), able to induce immunologic memory, would improve the immune response     against SP polysaccharides (SPP).      Primary objective: To evaluate and compare the specific antibody response to a prime-boost     vaccine strategy combining PCV prime at W0 followed by the administration of PSV boost at W4,     to the administration of PSV alone at W4 in patients with sickle cells disease.      Secondary objectives: Evaluation and comparison of the specific antibody response to the     thirteen pneumococcal serotypes shared by the PCV and PSV vaccines, 4 weeks after the single     PSV vaccination for patients from Group 1 or 4 weeks after the boost PSV vaccination for     patients from group 2. Evaluation of the duration of the specific antibody response at W24     and 96. Evaluation of the T CD4 lymphocyte response to the CRM 197 protein. Safety of the     vaccines.      Study Design: Randomised, monocentric, controlled phase II study of the immunological     efficacy of a prime boost strategy combining the sequential administration of the PCV and     PSV, compared to the administration of the PSV alone. 180 adults patients with sickle cells     disease will be included. The primary endpoint : proportion of responders at W8 to at least     10 of thirteen serotypes. Secondary endpoints : Proportion of responders at W8 according to 4     categories of responders: 5-7; 3-4; 2-1 and 0. Evaluation of the pneumococcal     opsonophagocytic activity (OPA) at baseline and W8 for each serotype, defined as the     proportion of patients with OPA > 1:8 geometric mean of the specific antibody titers     proportion of patients who experienced an increase of specific antibody levels 1 g/ml.     Evaluation of the priming effect of the PCV vaccine in the group 1. Duration of the specific     antibody responses at week 24 and W96. CD4 T lymphocyte responses to the CRM 197 protein     (proliferative and cytokine production) at weeks 0, 8 and 12. Safety of the vaccines     frequency of Streptococcus pneumoniae infections.      Statistical Considerations: With a sample size of 180 patients, and a randomization ration of     1:1, the study will have a power of at least 90% to show a difference of 25% category between     the group receiving PCV and PSV vs the group receiving PSV alone (two-sided type I error =     5%). The primary comparison between both groups will be performed using a Chi2 test for     independent groups or a Fisher exact test where appropriate.   "
77273|NCT02274402|"     This is a monocentric study, in the Internal Medicine Service of Cochin Hospital, Paris. Our     main objective is to determine the pharmacokinetic properties of prednisone, secondary     objectives are to determine the covariates affecting the prednisone pharmacokinetics and the     relationship between glucocorticoid exposition levels and their side effects. The     investigators will use a prospective, observational, population pharmacokinetic approach. 100     patients starting a prednisone treatment >7,5mg/d for an expected period >3 months will be     recruited and followed over 6 months.   "
77274|NCT02274389|"     The purpose of this study is to describe the medical indication and utilization of expert     medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility     based on minimum inhibitory concentrations (MICs) reported for baseline and subsequent     isolates, BDQ drug utilization data to include dose, duration, past treatment history, past     medical history, concomitant medications, and health care site of treatment, drug     distribution mechanisms used in the administration of BDQ, patient outcomes (clinical and     microbiologic) and adverse events among BDQ-treated participants, including deaths.   "
77275|NCT02274376|"     This observational study will collect prospective data on the safety and tolerability of     Xeloda in patients with advanced gastric cancer from every day clinical practice.     Documentation of treatment for each patient is to continue until the end of treatment per     oncologist's assessment.   "
77276|NCT02274363|"     The purpose of this study is to assess the severity of plaque‐type psoriasis (common     genetically determined, chronic, inflammatory skin disease characterized by rounded     erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp,     genitalia, extensor surfaces, and the lumbosacral region) in brazilian participants with     chronic plaque-type psoriasis.   "
77277|NCT02274350|"     The aim of this study is:        -  To investigate which sexual side effects occur after external beam radiation therapy and          brachie therapy        -  To investigate how many patients are affected        -  To investigate if there is a time dependency for the severity of the sexual side effects        -  To investigate if there is a dose dependency for the severity of the sexual side effects        -  To find predicting and associated factors for the discovered sexual side effects to help          identifying patients at risk   "
77282|NCT02274285|"     Primary objective:        -  To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP),          Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3          antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B:          DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary          vaccination (all antigens).      Secondary objectives:        -  To describe immune responses against all vaccine antigens with no pre-specified          hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4)          in the two study groups (Group A and Group B).        -  To describe the safety after each dose of each vaccine in the two study groups (Group A          and Group B).        -  To describe immune responses against all vaccine antigens with no pre-specified          hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4          (Group C)   "
77283|NCT02274272|"     The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263     capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of     adults with type2 DM.   "
77284|NCT02274259|"     Comparing ranibizumab and aflibercept in a treat and extend algorithm evaluating the number     of needed injections over a 18 month period in patients with newly diagnosed CRVO.   "
77288|NCT02274207|"     The purpose of this study is to test therapeutic benefits of silver dressing compared with     non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may     antibacterial effect on infected diabetes mellitus foot.   "
77289|NCT02274194|"     The obstructive sleep apnea (OSA) affects between 10% to 25% of the adults. Continuous     positive airway pressure (CPAP) is the chosen treatment in moderate and severe OSA. However,     the adherence to CPAP varies, and the interface between patient and the CPAP may interfere     with adherence, comfort and efficiency. Objectives: (1) to determine which is the preferred     airway flow in oral and nasal breathers, (2) to analyze the role of body position on the     nasal mucosa and the airways after one night CPAP titration, (3) the effects of nasal and     oronasal CPAP on the nasal epithelium and airways, inflammation in nasal lavage and miRNA     changes in blood and (4) CPAP adherence after 12 months. Population: 20 patients with     moderate/severe OSA recruited at Sleep Laboratory of Heart Institute - Hospital das Clínicas     da Faculdade de Medicina da Universidade de São Paulo.   "
77290|NCT02274181|"     The purpose of this study is to investigate the route(s) of elimination and mass balance of     enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~])     500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.   "
77291|NCT02274168|"     With the increasing use of implantable cardioverter defibrillators (ICD) for primary     prevention in patients with structural heart disease, an increasing number of patients are     expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an     ICD is in place and the only documentation of the clinical arrhythmia will be the ICD     electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained     monomorphic VT represents a limitation when performing treatment with radiofrequency (RF)     ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a     reference model of VT with clinical expression consisting of the electrical signal of the     ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This     will allow for a more targeted approach to the substrate of the VT with clinical expression     because: 1) if VT is induced by programmed stimulation, one can tell whether it is with     clinical expression or not, and 2) if VT is not induced, ventricular pacing could be     performed based on the comparative analysis of morphology and activation times of ICD-EG.     These approaches will result in improved outcomes of the ablation procedure.   "
77292|NCT02274155|"     The purpose of this study is to test the safety of the anti-OX40 antibody, MEDI6469, given     prior to surgery in patients with advanced head and neck squamous cell carcinoma.   "
77293|NCT02274142|"     The aim of this protocol is to evaluate the cost-efficacy of different glass ionomer cements     in Atraumatic Restorative Treatment restorations, with different handling characteristics:     powder-liquid versus encapsulated.   "
77295|NCT02274116|"     The purpose of this study is to determine how the nervous system controlling leg muscles is     altered following spinal cord injury and how they may be affected by brief periods of low     oxygen inhalation over time.      The investigators hypothesize:        -  Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength          in persons with incomplete cervical spinal cord injury (SCI)        -  AIH exposure will increase multijoint reflex excitability of leg muscles in persons with          incomplete cervical SCI        -  AIH exposure will increase walking performance in persons with incomplete cervical SCI   "
77296|NCT02274103|"     Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with     poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM.     Examined the differential impact on the youth's adherence to the diabetes medical regimen and     the youth's blood sugar control.   "
77297|NCT02274090|"     This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe     periodontitis subject.   "
77300|NCT02274051|"     This is a study of kinetin, a nutritional supplement that corrects the mRNA splicing defect     in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary     sensory and autonomic neuropathy type III). FD is a rare fatal autosomal recessive disease in     which the growth and development of selective neuronal populations is impaired. The disease     is the result of a point mutation in the gene sequence that encodes for kinase complex     associated protein (IKAP) in chromosome 9q31. The mutation, at the start of the non-encoding     intron 20, weakens the splice site, causing the spliceosome to wrongly join together exons 19     and 21 when transcribing the mRNA strand and miss out exon 20. The mutated mRNA produces a     short unstable IKAP protein that is quickly degraded. Interestingly, the mutation does not     lead to a complete loss of function. Instead, it results in a tissue specific deficiency in     splicing efficiency with both normal (wild type) and mutant IKAP mRNA being expressed in     different ratios in different tissues. Some cells, like fibroblasts, produce mostly normal     mRNA and protein, where as others, like neurons, produce mostly mutant mRNA and almost no     functional protein product.   "
77301|NCT02274038|"     The investigators will test the hypothesis that positron emission tomography (PET) imaging     with the imaging agent 18F-thymidine (FLT) can rapidly assess treatment response in patients     with unresectable non-small cell lung cancer (NSCLC).   "
77302|NCT02274025|"     NovellusDx technology identifies tumor-specific driver mutations, but unlike sequencing-based     tests, NovellusDx has a functional assay that detects dis-regulated translocation of mutated     signaling proteins to the nucleus. This allows NovellusDx to identify functionally-impactful     driver mutations regardless of whether the mutation has previously been described or linked     to a tumor type.   "
77303|NCT02274012|"     The investigators are doing this research program to find out if the investigational drug,     afatinib which is a medication known to block the function of the ErbB2 protein might help     standard chemotherapy, in particular paclitaxel, work better.      Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2. On July     12, 2013 the United States Food and Drug Administration (US FDA) approved afatinib for the     first-line treatment of patients with metastatic non-small cell lung cancer whose tumors had     specific EGFR gene mutations (exon 19 deletions or exon 21 i.e. L858R substitution mutations)     as detected by an FDA approved test.      Paclitaxel is a standard, anti-cancer medicine that has been approved by the US Food and Drug     Administration (FDA) for the treatment of lung cancer.      The combination of Afatinib and Paclitaxel are considered investigational when used in this     research program. An investigational drug is a drug that is not approved by the FDA for its     indication.   "
77951|NCT02265536|"     The main purpose of this study is to learn more about how the investigational drug,     LY3022855, affects the immune system in participants with advanced breast or prostate cancer     that has not responded to other treatments. Treatment may last up to 6 cycles (cycle = 6     weeks).   "
77304|NCT02273999|"     This randomized clinical trial was designed to assess the clinical efficacy of Pulsed     electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain     and quality of healing after mandibular third molar extraction.      The sample included 120 patients undergoing unilateral mandibular third molar extraction. The     devices were positioned over the area corresponding to the extraction site and wearers were     asked to keep them in place for 7 days. All patients were asked to record pain (on a visual     analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics.     At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain     on palpation, postoperative bleeding, alveolitis) were recorded blindly.   "
77305|NCT02273986|"     The purpose of this study is to assess the effects of K-877 on the pharmacokinetics of     digoxin in healthy adult volunteers.   "
77306|NCT02273973|"     This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the     effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and     placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth     factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be     randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at     2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets)     or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.   "
77307|NCT02273960|"     The purpose of this study is to assess the safety and tolerability of BMS-986004 when     administered in subjects with ITP.   "
77308|NCT02273947|"     The purpose of this study is to assess the impact of a light meal, a standard meal, and a     high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted     conditions.   "
77309|NCT02273934|"     The purpose of this study is to determine whether a special kind of rehabilitation offered to     home-dwelling adults is effective with regards to functional ability, health-related quality     of life, coping, mental health and municipal costs.   "
77310|NCT02273921|"     The goal of this study is to construct a large database of EEG recordings from elderly     individuals in predefined groups. The purpose of this database is to select groups of EEG     recordings from the database in order to compare the electrophysiology, as measured by EEG,     of the groups.      In the clinical trial part all individuals are treated exactly the same and are therefore     considered a single group. The categorization is performed during the data analysis.      The groups in the data analysis will initially be based on the following:        1. Healthy controls        2. Mild Cognitive Impairment        3. Alzheimers Disease (AD)        4. Lewy-body Dementia        5. Parkinsons Disease Dementia        6. Vascular Dementia (VaD)        7. Frontotemporal Dementia (FTD)        8. Depression      Other groups will be added if needed.   "
77311|NCT02273908|"     The purpose of this study is to evaluate the effect of pregabalin comparing with the     conventional analgesic care in chronic low back pain patients with accompanying lower limb     pain (neuropathic component) treated in primary care settings under routine clinical     practice.   "
77312|NCT02273895|"     The objective of this study is to compare the electroencephalography (EEG) responses of three     distinct groups of individuals to scopolamine: 1) a group of Alzheimer Dementia (AD)     patients, 2) a group of individuals suffering from Mild Cognitive Impairment (MCI) and 3) a     group of controls. The main purpose of this comparison is to discover ways to use these     responses to distinguish between the group of AD patients and controls in order to develop a     diagnostic tool for AD. The purpose of including the MCI group is to investigate whether this     diagnostic tool can predict which member of the MCI group will develop AD later in life.   "
77345|NCT02273466|"     To assess the steady state pharmacokinetics of Desipramine with/without concomitant     administration of Crobenetine.   "
77315|NCT02273856|"     The purpose of this study is to document the pharmacological treatment strategies used in     treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle     East and North African (MENA) region. This study will also record encountered tumor subtype     and stage and the instituted pharmacological treatments, as well as assess the clinical     outcomes of treatments.   "
77316|NCT02273843|"     This is a randomized controlled trial (RCT) to evaluate the influence of different doses of     vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and     C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to     assess its influence on clinical outcomes of these infants.   "
77317|NCT02273830|"     The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD     patients without conventional for LTOT but with exercise desaturation.   "
77318|NCT02273817|"     This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the     marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to     evaluate the safety and tolerability of generic ciclesonide nasal spray compared with     Omnaris™ nasal spray.   "
77319|NCT02273804|"     The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body     Mass Index compared to placebo at 9 months.   "
77320|NCT02273791|"     Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation     prior to frozen-thawed embryo transfer (FET) in patients with polycystic ovarian syndrome     (PCOS)   "
77353|NCT02273362|"     This pilot clinical trial studies the best dose of erlotinib hydrochloride and to see how     well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver     undergoing surgery. Erlotinib hydrochloride may help to inhibit the development of fibrous     tissue and prevent liver cancer from forming in patients with cirrhosis of the liver.   "
77354|NCT02273349|"     The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung     Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused     emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction     profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating     improvement in lung function, exercise capacity, and quality of life relative to their     baseline status.   "
77355|NCT02273336|"     This research trial studies genomic analysis in tissue and blood samples from young patients     with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid     [DNA]) may help doctors tailor treatment to target the specific mutations and help plan     effective treatment.   "
77321|NCT02273778|"     Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure     while preserving patients' quality of life including their ability to speak and swallow. In     order to reduce the potentially major side effects of treatment, it is essential that the     highest doses of radiotherapy are targeted to the main bulk of the tumour. At present a     computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for     planning the radiotherapy treatment. The investigators know that other types of scan     including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are     better than CT scans at showing areas involved by the cancer. However, radiotherapy cannot be     directly planned on these types of scans. The aim of this study is to explore whether PET and     MRI scans can be combined with CT scans to more accurately identify the tumour target. In     addition, this study will explore whether PETCT and MRI scans may used to adjust radiotherapy     to how well a tumour is responding during a course of radiotherapy. If the radiotherapy     planning process can be improved in these ways, the investigators hope future patients will     benefit by more chance of cure with a reduction in the side effects of treatment. The study     aims to recruit 16 patients. All patients within the study will undergo a PETCT and an MRI     scan prior to starting treatment as part of the study. A subgroup of 8 patients will undergo     additional imaging at two timepoints during the course of their radiotherapy. The study is     noninterventional and patients' standard treatment will not be affected by their     participation in the study.   "
77322|NCT02273765|"     Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral     treatment of HIV-infected patients with tuberculosis.   "
77323|NCT02273752|"     This phase II trial studies how well real-time pharmacokinetic therapeutic drug monitoring     works in preventing stomatitis from developing in patients with hormone receptor positive     breast cancer, pancreatic neuroendocrine tumors, or kidney cancer that are receiving a type     of cancer drug called everolimus. Stomatitis is a common side effect of everolimus that     causes inflammation of the mouth, with or without oral ulcers, and frequently leads to     patients discontinuing the medication. Monitoring the blood levels of everolimus and making     adjustments in a patient's dose may be able to decrease the incidence of stomatitis, while     maintaining the effectiveness of everolimus to treat the cancer.   "
77324|NCT02273739|"     The purpose of this Phase 1/2, multi-center study is to evaluate the safety,     pharmacokinetics, pharmacodynamics and clinical activity of AG-221 in subjects with advanced     solid tumors, including glioma, and with angioimmunoblastic T-cell lymphoma (AITL), with an     IDH2 mutation. The first portion of the study is a dose escalation phase where cohorts of     patients will receive ascending oral doses of AG-221 to determine maximum tolerated dose     (MTD) and/or the recommended Phase 2 dose. The second portion of the study is a planned dose     expansion phase where three cohorts of patients will receive AG-221 to further evaluate the     safety, tolerability, and clinical activity. Anticipated time on study treatment is until     disease progression or unacceptable toxicity occurs.   "
77325|NCT02273726|"     The purpose of this study is to determine whether roxadustat is effective and safe compared     to epoetin alfa in the maintenance treatment of anemia in stable hemodialysis and peritoneal     dialysis subjects when converted from their existing stable erythropoiesis stimulating agent     treatment.      Amendment 1: The primary purpose of this amendment is to evaluate safety and efficacy of     roxadustat compared to epoetin-alfa in newly initiated (incident) dialysis subjects who have     been on ESA (≥ 4 weeks) for treatment of anemia prior to screening   "
77326|NCT02273713|"     Oesophagogastric cancer is a major cause of cancer related mortality, with an overall 5-year     survival rate of 10% worldwide and patients are often diagnosed with locally advanced or     metastasized disease at first presentation. For advanced oesophagogastric cancer     fluoropyrimidines are the backbone of palliative chemotherapy and is commonly used in 2- or     3-drug combinations .      However, in clinical practice after progression on first line therapy, a substantial number     of oesophagogastric cancer patients may not be able to start second line chemotherapy due to     rapid clinical deterioration. Therefore, new triplets with high anti-tumor activity and low     toxicity are urgently needed.      Given the activity of capecitabine and oxaliplatin containing regimens and the potential of     taxanes in oesophagogastric cancer, the investigators propose a phase I study combining     capecitabine and oxaliplatin with Nab-paclitaxel.      Solvent-based taxanes (paclitaxel, docetaxel) can cause severe toxicities not only by the     active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane) is a     solvent-free formulation of paclitaxel encapsulated in albumin. It does not require     premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated     hypersensitivity reactions. This new formulation improves safety profile, allows higher     dosing with shorter infusion duration, and produces higher tumor drug concentration. It has     proven activity in breast cancer, non small lung cancer and pancreatic cancer, as well as in     gastric cancer models.   "
77327|NCT02273700|"     The main objective of this pilot study is to investigate the protein / peptide plasma     profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients     with non-valvular atrial fibrillation to better understand the mechanisms of action of these     molecules and perform exploratory analyses concerning proteins whose concentrations change     after starting treatment.   "
77328|NCT02273687|"     The main objective of this study is to show that diaphragmatic excursion measures upon     emergency admission (CDA values) on patients with acute respiratory failure are predictive     of the need to use mechanical ventilation (invasive or non-) in the first four hours.   "
77329|NCT02273674|"     The purpose of this study is to determine the potential effects of repetitive transcranial     magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in     borderline personality disorder patients. Specially in cognitive flexibility, inhibition     control and social cognition.   "
77330|NCT02273661|"     Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a     strategy with a maintenance treatment and a conventional strategy without antifungal     maintenance therapy.   "
77356|NCT02273323|"     Research indicate that people who regularly drink tea have a reduced risk of stroke or heart     disease. In a number of studies in which people that normally do not drink showed that their     blood vessels function improved when the drunk tea. The current study tests whether a     specific black tea improves vessel function in non-tea drinking hypertensive subjects.   "
77331|NCT02273648|"     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to     long-term complications range from rather immediate elastic coil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),     designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis     rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS     substantially reduced the incidence of abrupt artery closure, but restenosis still occurred     in about 20 to 40% of cases, necessitating repeat procedures.      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by     adding an antiproliferative drug (directly immobilized on the stent surface or released from     a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS     with systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease.      Therefore this observational registry has been designed for the clinical evaluation of the     ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and     collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting     Stent System in an all-comers patient population in daily clinical practice.   "
77332|NCT02273635|"     The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg     administered twice a day orally versus a placebo as a modifying treatment of the disease in     patients with the progressive forms of Multiple Sclerosis (MS).      The principal outcome is to determine the efficacy, of andrographolide in retarding the     progression of brain atrophy in patients with progressive forms of MS.   "
77333|NCT02273622|"     Explore the detoxifying potential of hydroxytyrosol and its effects on Phase II enzyme     expression (leading to xenobiotics detoxification in the liver).   "
77334|NCT02273609|"     The primary objective of this study was to determine rates of INR control of patients with     nonvalvular AF daily attended in primary care in Spain.      PAULA is an observational retrospective/cross-sectional and multicenter study. Patients aged     ≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care     were included in the study. To be included, at least 80% of INR values during the past 12     months should be available. Before inclusion, patients provided written consent.      Clinical data (biodemographic data, comorbidities, treatments, and thromboembolic/bleeding     risk) were recorded from the clinical history of patients at the moment of inclusion. INR     values were taken from the previous 12 months of inclusion.      Poor INR control was considered when percent time in therapeutic INR range (TTR) was <65%     (calculated by Rosendaal method) or <60% by direct method (proportion of INR values).      A total of 1,524 patients have been included in the study.   "
77335|NCT02273596|"     The purpose of the study is to evaluate the efficacy and safety of WTX101 administered for 24     weeks in newly diagnosed Wilson Disease (WD) patients aged 18 and older with     Nonceruloplasmin-bound copper (NCC) levels within or above the normal reference range at the     time of enrollment. Subjects with Wilson Disease who have received either no prior Wilson     Disease treatments, or have been treated for up to and including 24 months prior to study     enrollment with chelation therapy (e.g. trientine, penicillamine), zinc therapy or     combination therapy are eligible to participate, if all other inclusion and no exclusion     criteria are met. The purpose of the 12 month Extension Phase is to evaluate the durability,     and establish long-term safety and efficacy of WTX101.   "
77336|NCT02273583|"     Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective     against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of     maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with     high grade, operable, non-metastatic osteosarcoma (OST) of the extremities. The primary end     point is event-free survival (EFS) from randomization.   "
77337|NCT02273570|"     Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD)     on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder     (CKD-MBD)   "
77338|NCT02273557|"     The objective of this study was to compare the pharmacokinetics of dipyridamole in three     different Asasantin ER batches (test) containing different amounts of retarding lacquers to     the existing commercial product at steady state with BID treatment   "
77339|NCT02273544|"     The objective of this study was to compare the pharmacokinetics of dipyridamole in three     different Asasantin ER batches (test) containing different amounts of retarding lacquers to     the existing commercial product at steady state with b.i.d. treatment   "
77340|NCT02273531|"     Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the     present commercially available Asasantin ER formulation (Aggrenox®)   "
77341|NCT02273518|"     Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared     to the present commercial formulation   "
77342|NCT02273505|"     Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release     Persantin tablets combined with Acetyl salicylic acid (ASA) tablets   "
77343|NCT02273492|"     Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state   "
77344|NCT02273479|"     Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in     multiple administration to healthy adult male volunteers.   "
77349|NCT02273414|"     The objective of the present study is to obtain information about the safety and tolerability     of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by     determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary     pharmacokinetic data concerning steady state and accumulation factor   "
77350|NCT02273401|"     To investigate safety, tolerability, and pharmacokinetics of BI 11054   "
77351|NCT02273388|"     The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI     6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection     of overall safety and antitumour efficacy data and the determination of the pharmacokinetic     profile of BI 6727.   "
77352|NCT02273375|"     The purpose of this study is to find out whether it is better to receive a new drug,     MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy)     for lung cancer.   "
78386|NCT02259881|"     To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters     of coagulation, platelet activation and inflammation in a model of tissue factor triggered     activation of the coagulation system; to examine the safety of BIBT 986 in this setting   "
77357|NCT02273310|"     This study aims to develop an effective, brief, family-based intervention targeting quality     of life and school functioning for youth with sickle cell disease. Utilizing a randomized,     delayed control group intervention methodology, the present study will systematically     document the effectiveness of a family-based, one-day intervention plus booster phone calls     to improve quality of life and increase school functioning for children with sickle cell     disease transitioning to school and their families.   "
77358|NCT02273297|"     The purpose of this study is to establish and follow longitudinally a cohort of ethnically     diverse pregnant women and their offspring, in order to explore the hypothesis that fetal     over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the     offspring.   "
77359|NCT02273284|"     The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children and     youth who suffer from stiffness of their muscles due to a neurological problem. These     injections are given into each muscles which require treatment, which often means receiving     multiple injections in one session. Intramuscular injections are typically painful. Treatment     can be provided unsedated and then should incorporate distraction and relaxation techniques,     or can be alternatively be provided with the use of sedation.      To improve the pain experience the investigators want to assess the feasibility and impact on     the pain perception when using a vibration device called the Buzzy during BoNT-A injections.     The Buzzy creates a vibration that is applied over the injection site for 30 seconds before     the injection and will be continued just above the injection site during the injection. The     Buzzy has been shown to help reduce pain in procedures such as i.v. insertions and     immunizations, but has not been tested in children and youth receiving multiple BoNT-A     injections.   "
77360|NCT02273271|"     The purpose of the study is to qualify, independently, tumor cell proliferation by     3'-Deoxy-3'-[18F]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by     Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological     quantification (% of viable tumor cells) of the primary tumor after pre-operative     chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).   "
77361|NCT02273258|"     Primary Objective:      To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.      Secondary Objective:      To assess the safety and tolerability of SAR342434.   "
77362|NCT02273245|"     Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest     pain. There are several possible underlying causes, which cannot be distinguished from one     another at the bedside.      Current practice is to image this with two CT scans of the chest, one before injection of a     contrast dye into the blood stream and then one after.      With the advancement of CT scanner technology, improvements in software interpretation and     screen resolution, the investigators hypothesise that performing the contrast scan on its own     is diagnostically equivalent to both the pre- and contrast scans   "
77363|NCT02273232|"     Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic     patients in which exposing the limbs for periods of short intermittent ischemia produces     protective effect on heart muscle. The concept was applied to many other parts of the body     and the results are positive so far.      No human trials on this concept has been conducted in patients with peripheral vascular     disease so far but applying the concept for healthy individuals shows vessels dilatation and     animal trials shows degree of new vessels formation in addition to reports of symptoms     improvement.      The trial candidates will be allocated blindly in 4 groups. All groups will have advice about     exercise which is the standard practice now. The first group will have supervised exercise.     The second group will in addition to the supervised exercise get the ischemic preconditioning     with the blood pressure cuff. The third group will get the ischemic preconditioning and the     fourth group will get the standard exercise advice. All candidates will have Magnetic     Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at     the end.      The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms,     new vessel formation and other parameters will be recorded   "
77365|NCT02273206|"     Bronx County, New York is the poorest urban county in the U.S.A., and residents are almost     entirely Latino or African American. Cancer is the leading cause of premature death in the     Bronx, with morality rates significantly higher than for New York City as a whole.     Low-income/minority populations are more likely to be diagnosed with preventable and     late-stage cancers than the general population, in part, due to lower screening rates. While     research has addressed screening barriers in low-income/minority groups, depression, a     common,potentially critical barrier, has received scant attention. Research suggests that     depressed women are less likely to engage in cancer screening, especially mammography and Pap     testing. The link between mental health and cancer screening is particularly important to     address in the Bronx, which has the highest rates of self-reported serious psychological     distress (a measure closely related to depression) in New York City. Depression affects     almost 1 in 4 minority women, and while minorities often seek help for depression in primary     care, primary care depression management often does not meet evidence-based standards.     Drawing on the expertise and close collaboration of Bronx medical and social service     providers and patient stakeholders, this study will determine whether a collaborative care     intervention that addresses both depression and cancer screening needs simultaneously among     women ages 50-64 is more effective at improving cancer screening and patient-reported     outcomes for women with depression than an existing evidence-based cancer screening     intervention alone.      To achieve this, the investigators will compare the effectiveness of these two interventions     using a randomized controlled trial (RCT). In partnership with three Bronx Federally     Qualified Health Centers (FQHCs), the investigators will recruit approximately 756 women ages     50-64 who screen positive for depression and are non-adherent with recommended cervical,     breast, and/or colorectal cancer screenings. The investigators specific aims are to: 1)     compare the impact of the two interventions on patient-reported outcomes, including cancer     screening knowledge and attitudes, self-efficacy, depression-related stigma, provider     referrals, participation in mental health care, medication adherence, quality of life,     satisfaction with care and treatment decisions, and depression; 2) compare the effectiveness     of the two interventions in increasing breast, cervical, and colorectal cancer screening; 3)     determine whether reducing depression increases the likelihood that low-income women 50-64     will receive cancer screening; 4) determine whether effectiveness of the two interventions in     increasing cancer screening varies according to patient characteristics, such as duration of     depression, presence of other chronic conditions, and obesity.      This study is designed to increase the investigators understanding of how to enhance primary     care systems' ability to improve a range of outcomes related to cancer screening and     depression among low-income minority women, and how to best support this population in making     cancer-screening decisions.   "
77430|NCT02272361|"     The primary objective of this study is to compare with PFDI-20 questionnaire the functional     outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of     symptomatic exteriorised cystocele up to 4 years after surgery.      The secondary objectives of this study are the following:        1. to compare the two techniques for anatomical results based on the clinical evaluation of          patients with POP-Q.        2. to overall quality of life assessment and expectations of patients.        3. to compare the two techniques for the long-term safety. The evaluation will focus on the          adverse effects of long-term sexual and genital symptoms, urinary and digestive          functional symptoms, and chronic pelvic pain.        4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire          (matched-analysis before versus after).   "
77366|NCT02273193|"     A prospective cohort research study is being conducted in the Mike O'Callaghan Federal     Medical Center (MOFMC), Department of Family Medicine, Obstetrics Clinic to determine if     early screening with hemoglobin A1C, a blood test for blood glucose, can be used to identify     women with hyperglycemia or Gestational Diabetes Mellitus (GDM) in the first semester of     pregnancy in place of a fasting blood glucose blood test. This study will also determine how     hemoglobin A1C compares with the oral glucose tolerance test (GTT) done as a standard of care     with the standard of care second trimester prenatal care testing. Subjects recruited and     consented during the Obstetrics Orientation Class will have two (2) additional blood tests     drawn with their standard of care prenatal tests in the first trimester (<13 weeks) of     pregnancy and at the second trimester (24-28 weeks) of pregnancy. Subjects identified as     having GDM by blood HbA1C, fasting glucose or the 2 hr OGTT will be treated for GDM with     standard of care by their primary care provider. The correlation of blood HbA1C with the     fasting glucose in the first trimester of pregnancy and with the 2 hr OGTT will be determined     for early detection and diagnosis of GDM. This study will contribute to understanding the     role of HbA1C in pregnancy and the development of GDM.   "
77367|NCT02273180|"     Primary Objective:      To demonstrate non-inferiority of SAR342434 versus Humalog in HbA1c change in patients with     type 1 diabetes mellitus (T1DM) also using insulin glargine.      Secondary Objectives:      To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status     and antibody titers at baseline and during the course of the study.      To assess the relationship of anti-insulin antibodies with efficacy and safety including     during the safety extension.      To assess the efficacy of SAR342434 and Humalog in terms of proportion of patients reaching     target HbA1c (<7%) and on fasting plasma glucose (FPG), self-measured plasma glucose (SMPG)     profiles, and insulin dose.      To assess safety of SAR342434 and Humalog.   "
77368|NCT02273167|"     This study evaluates the efficacy, safety and tolerability of NER1006 compared with MOVIPREP     in adult patients requiring bowel cleansing prior to any procedure that requires a clean     bowel, using a 2-Day Split-Dosing and 1-Day Morning Split-Dosing regimens. Approximately 810     patients will be randomised with the aim of achieving a minimum of 245 patients in each of     the 3 groups.   "
77369|NCT02273154|"     This is a Multicenter, open lable, parallel randomized controlled clinical trial.      This study aimed to evaluate the treatment onset time, efficacy and safety in patients with     major depressive disorders , accompanying anxiety receiving Buspirone and Paroxetine.   "
77370|NCT02273141|"     The study evaluates the safety efficacy and tolerability of NER1006 versus a Sodium     picosulfate and Magnesium salt solution in overall bowel cleansing using a day before only     dosing regimen in adults. It is anticipated that approximately 484 patients will be     randomised. Half of the participants will receive NER1006 while the other half will receive     Sodium picosulfate and magnesium salt.   "
77371|NCT02273128|"     Osteoporosis and Periodontitis are multifactorial diseases which share common risk     factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor     gene? in patients with Osteoporosis and Periodontitis.   "
77372|NCT02273115|"     The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for     induction of labor will increase the rate of delivery within 24 hours stratified by parity.   "
77373|NCT02273102|"     Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients.     Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases,     is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid     (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be     cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect.     Consequently, 85% of these patients will succumb to their disease despite conventional     approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This     knowledge gap limits the use of ATRA in a disease that already has few effective therapies.     The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to     ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators'     publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP),     unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA     and TCP markedly diminished the engraftment of primary human AML cells in murine models,     indicating that the combination may target leukemia-initiating cells (LIC). The     investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may     contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that     ATRA combined with TCP will be safe and effective in a clinical population, and that this     approach will suppress LICs and restore myeloid differentiation programs in patients with     non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this     protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer     effects of ATRA to all AML subtypes.   "
77376|NCT02273063|"     The purpose of this study is to see how well a treatment called Repetitive Transcranial     Magnetic Stimulation works for patients who struggle with symptoms of both posttraumatic     stress disorder and major depressive disorder.   "
77377|NCT02273050|"     A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the     Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy     Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2     Diabetes who have Inadequate Glycaemic Control   "
77431|NCT02272348|"     Therapeutic education of patients is a mandatory component of intensive insulin therapy of     type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim     at facilitating patients' autonomy in their own management of diabetes. Therefore,     self-management of patient with type 1 diabetes must be systematically assessed in order to     evaluate the effectiveness of education programs .The main objective of this prospective     controlled randomized monocentric study is to assess the impact of functional insulin therapy     on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes     Self-care scale (CIDS) test.   "
77483|NCT02271659|"     The aim of the present phase III study is two-folded: 1) to show a superiority of external     beam radiotherapy combined with a brachytherapy boost versus exclusive external beam     radiotherapy and 2) to evaluate the economic impact of each treatment.      The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is     of 5 years.   "
77378|NCT02273037|"     A novel handheld Doppler has been developed which is rugged and is powered only by a hand     crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the     fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that     with its ease of use, both for the woman and midwife, midwives using the Doppler will     identify more babies in need of prompt delivery and the risk of stillbirth and neonatal     mortality will decline. In the research study, the investigators will compare the risk of     stillbirths and neonatal mortality in two randomized groups of labouring women.      The second part of the study consists of an audit of the documentation in labour by midwives.     The partograph is an uncomplicated, low cost form on which observations during labour are     documented. It includes three sections of information: fetal condition, maternal condition     and labour progress. Although the use of a partograph during labour is strongly recommended     by the WHO, there are limited published systematic evaluations of the correct use of the     tool. The investigators aim to use this randomized trial design to assess rates of     intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and     assess the quality of partographs comparing two groups.      This trial will provide insights on the potential benefits of using handheld Doppler devices     for intrapartum monitoring, and the audit of partograph quality will provide insights to     improve care during labour. This study hypothesizes that the quality of partograph completion     and of fetal heart rate monitoring may systematically differ between the Doppler and Pinard     groups.   "
77379|NCT02273024|"     The investigators hypothesize that inactivity during the search for a donor may exacerbate     current deconditioned states; subsequently, influencing risk factors for post-transplant     complications that hinder the recovery phase.      This study is designed to investigate if exercise therapy administered prior to allogeneic     hematologic stem cell transplantation (HSCT) can influence physical and psychological     side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be     randomized into either an exercise group or usual care group and followed until one year     after HSCT.   "
77380|NCT02273011|"     Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both     well-established anesthetic methods for caesarean section. CSEA combines the advantages of     spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management.     The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA     continuous epidural administration of local anesthetics versus SSSA with oral pain medication     in the postoperative period.   "
77381|NCT02272998|"     This phase II trial studies how well ponatinib hydrochloride works in treating patients with     cancer that has spread to other parts of the body (metastatic), has failed previous treatment     (refractory), and has one of several alterations, or mutations, in its deoxyribonucleic acid     (DNA) sequence. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. It is not yet known whether a patient's genetic     alterations may affect how well ponatinib hydrochloride works.   "
77382|NCT02272985|"     The purpose of this study is to evaluate the effect of the hemodialysis procedure on cerebral     blood flow (CBF) in elderly maintenance hemodialysis (HD) patients. The investigators     hypothesize that HD induced blood pressure changes are associated with a fall in global     and/or regional CBF during HD. Second, the investigators hypothesize that near infrared     spectroscopy (NIRS) will correlate with CBF measured by[15O]H2O PET.   "
77383|NCT02272972|"     This study consists of a retrospective and a prospective part. For each part and in each of 5     clinics, one intraoperative postimplant image (lateral view) of 25 patients with     pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two     assessments in the retrospective part. a) before an educational intervention, b) after the     educational intervention. The evaluated images at these two timepoints are identical. In the     prospective part, the surgeons apply their new knowledge from the educational intervention.     They perform the positioning of the patient during the intraoperative fluoroscopy and record     the image according to the teaching material. One postimplant image of each patient will be     used for the evaluation.      At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria     (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the     educational material.   "
77403|NCT02272712|"     Chronic insomnia affects more than 25% of cancer survivors, a rate double that of the general     population. The Pan-Canadian sleep guideline for adults with cancer recommends     Cognitive-Behavioral Therapy for Insomnia (CBT-I) as the best treatment. Major problems,     however, are the lack of available CBT-I at cancer centers and the lack of information about     possible side-effects of CBT-I. To address this issue, our study will evaluate the     effectiveness and potential short-term side-effects of an online version of CBT-I. It is     expected that when compared to cancer survivors who receive an online sleep education     program, those who receive online CBT-I will experience improved sleep, mood, and quality of     life, as well as reduced anxiety and fatigue.   "
77501|NCT02271425|"     Evacetrapib (study drug) is an investigational drug being developed with the aim to help     people at high risk of heart problems in the future.      In this study we will be comparing how much of the study drug gets into the blood stream when     it is given as a single dose (in tablet form) compared to an intravenous injection (given     directly into a vein via a small needle).      The study is expected to last at least 15 days for each participant, not including screening.     Screening will occur up to 28 days before the study drug is given.   "
77432|NCT02272335|"     The main goal of the proposed study is to test whether a successful stress management     intervention can be effectively implemented in natural settings in the community and will be     acceptable to a community dwelling, low income population of African American women with     breast cancer.      Hypothesis 1: There will be no differences between women randomized to either the Cognitive     Behavioral Stress Management (CBSM) or the Cancer Wellness and Education condition (CW) on     ratings of acceptability of the program.      Hypothesis 2: Women randomized to the CBSM condition will show greater decreases over time in     cancer-specific distress and greater increases over time in quality of life as compared to     women in the CW condition over the course of the study from baseline to six month follow-up.      Hypothesis 3: Women randomized to the CBSM condition will show greater improvement in pain     levels, sleep disturbance and fatigue as compared to women in the CW condition over the     course of the study from baseline to six month follow-up.      Hypothesis 4: Women randomized to the CBSM condition will report fewer sick days, earlier     return to work, fewer unanticipated health care visits, fewer visits to the Emergency     Department and better follow-up with oncologists as compared to women in the CW condition     over the course of the study from baseline to six month follow-up.      Hypothesis 5: Women randomized to the CBSM condition will show more normalized patterns of     diurnal cortisol (e.g., greater increase in negative AM-PM slope) as compared to women in the     CW condition over the course of the study from baseline to six month follow-up.      Hypothesis 6: Women randomized to the CBSM condition will show more less normalized patterns     of heart rate variability (e.g., more variation) as compared to women in the CW condition     over the course of the study from baseline to six month follow-up.   "
78885|NCT02253303|"     The purpose of this study is to evaluate the midline extraction incision in patients with     colon cancer. A prospective randomized controlled trial is conducted to compare midline     extraction incision with off-midline extraction incision.   "
77384|NCT02272959|"     First-line psychosocial treatments for anxiety disorders in children are largely     exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting     CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full     course of treatment. What are the treatment options for these youth? Unfortunately, there is     not a single empirical study in the youth anxiety treatment literature that has     systematically examined treatment augmentation for youth who fail to respond to CBT.     Empirical efforts to address this issue are important because youth who do not respond to CBT     continue to suffer emotional distress and impairment associated with anxiety disorders. This     study will address this gap via double-blind randomized controlled trial of Attention Bias     Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to standard     CBT. Attention biases in threat processing have been assigned a prominent role in the     etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to     implicitly modify biased attentional patterns in anxious patients. Here, participants will be     CBT non-responders who will be assessed by using clinical interviews and parent- and     self-rated questionnaires before and after eight sessions of ABMT or placebo control, and     again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the     Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We     also expect the findings to inform pathways to treatments for anxious children who do not     respond to current standard first-line therapy, and to provide initial information on     mechanisms of ABMT efficacy.   "
77385|NCT02272946|"     The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures     of systemic and vascular inflammation and endothelial function (all indicators of     cardiovascular risk) in treated and suppressed HIV infected individuals This study will     assess the safety and effects of canakinumab on endothelial function (assessed by     flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by     FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk     (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163),     D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20     individuals will receive a single dose of 150mg canakinumab with follow-up for 18 weeks.   "
77386|NCT02272933|"     In this observational study, a motion monitoring system including body-worn sensors,     communication portals, data capture system, and algorithms will be tested with geriatric     patients in Garrison Geriatric Education and Care Center (Lubbock, TX). The study is part of     a long-term effort to improve the quality of life and safety of geriatric patients by using     autonomous systems that can alert care givers of mobility issues and falls.   "
77387|NCT02272920|"     Research hypothesis:      Is the treatment with renal denervation (RDN) early post ACS safe and effective and does it     leads to improved cardiac function and attenuation of pathologic left ventricular     remodelling? In a following study, the hypothesis will be tested in a larger ACS population     with major adverse cardiovascular events (MACE) after ACS as the endpoint.      Rationale for conducting this study:      ACS i.e. ST-elevation myocardial infarction (STEMI) and non- ST-elevation myocardial     infarction (non-STEMI) are the most important causes of morbidity and mortality in western     societies. Hypertension is a major risk factor for development of ACS and heart failure but     it also worsens the prognosis in patients after ACS. Our research highlights the combination     therapy of PCI and RDN in an ACS patient population with simultaneous hypertension.      Primary objective:      The primary objective of this study is to establish safety and efficacy of combined treatment     with PCI and renal denervation (RDN) in hypertensive patients with acute coronary syndromes     (STEMI and non-STEMI ) having ventricular mass after 4 months as the primary variable.      Endpoints:      The primary end point is change in left ventricular mass (LVM) at 4 months evaluated by     magnetic resonance imaging (MRI).      Secondary endpoints:, blood pressure (office and 24-h ABPM), and left ventricular volumes and     ejection fraction.   "
77388|NCT02272907|"     The investigators hypothesize that staple line reinforcement will result in a higher leak     pressure than a non-reinforced staple line closure in the resected gastric specimens from     laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after     various staple line treatments. The investigators will also analyze the most common site of     specimen leak, association of stomach thickness to leak, association of stomach thickness to     performance of the staple line techniques, and a cost analysis.   "
77389|NCT02272894|"     This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node     dissection in 3-year survival rates of advanced gastric cancers.   "
77390|NCT02272881|"     The purpose of this study is to compare the number of and degree of pressure ulcers healed,     as measured by intact skin at the original ulcer site at 6 months of follow-up in patients     randomized to immediate operative closure versus those who are maintained in a wound care     program in patients with Stage 3 and 4 sacral and peri-sacral decubitus ulcers.   "
77391|NCT02272868|"     This is a double blind placebo control trial of fecal microbial transplantation for active     Crohn's disease in patients 12 to 21 years of age.   "
77392|NCT02272855|"     The purpose of this study is to determine if HF10 in combination with ipilimumab is effective     in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.   "
77419|NCT02272504|"     The objective of this study is to evaluate the clinical effectiveness of biomarkers,     alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and     des-gamma-carboxy prothrombin (DCP), for surveillance program patients whose hepatocellular     carcinoma (HCC) development may be potentially missed by ultrasound (US). This study expects     to demonstrate that addition of biomarkers will increase the detection rate by at least 10%.   "
77420|NCT02272491|"     The aim of the present study is to test whether or not the use of translucent monolithic     zirconia crowns bonded to a titanium base abutment perform similar to     porcelain-fused-to-metal crowns on single implants in the posterior region.   "
77502|NCT02271412|"     Objectives        -  To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in          healthy subjects.        -  To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.   "
77503|NCT02271399|"     The purpose of this study is to compare the efficacy of two prophylactic agent(aspirin     300mg/day and rivaroxaban 10mg/day) for venous thromboembolism after total knee arthroplasty.   "
77393|NCT02272842|"     Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient     deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is     crucial for normal cell division and is necessary for brain growth as well as for the     maintenance of its normal function. Deficiency is also associated with impaired growth. In a     previous study, we demonstrated that vitamin B12 administration over a period of six months     enhanced growth, and scores on a neuro-developmental test in young Indian children. However,     the overall effect was small and, for the developmental scores significant only in those that     were malnourished at the start of the study.      Our findings need to be verified in trials targeting younger, malnourished children and with     longer supplementation time.      Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2     recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted     children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration.      Study design: Randomized placebo-controlled trial. Half of the children will receive a paste     containing vitamin B12, the other half the same paste but without vitamin B12.      Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In     this population we have demonstrated that vitamin B12 deficiency and poor growth is common in     early childhood.      Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months      Data: The main outcomes of this study are scores on developmental assessments tools and     growth measured every month for 12 months.   "
77394|NCT02272829|"     This project will develop a novel collaborative treatment, based on the primary care     behavioral consultation model and behavior therapy techniques including motivational     interviewing and functional assessment, in which a patient, a Behavioral Health Consultant     (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed     opioid analgesics in older HIV+ adults. The intervention will involve meetings between the     BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. Opioid     misuse will be the primary outcome variable. Quality of the patient-provider relationship,     pain, problematic use of other substances, antiretroviral adherence, and psychosocial     functioning will be secondary outcomes.   "
77396|NCT02272803|"     The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone +     Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM)     in Japan.   "
77397|NCT02272790|"     A Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial     Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Patients will receive AZD1775 plus     carboplatin or AZD1775 plus weekly paclitaxel. The primary study objective is to evaluate the     objective response rate (ORR).   "
77398|NCT02272777|"     The extension study follows the core study CAMN107ECN02, which is an open-label, two armed     study. All patients enrolled in this extension study should be able to benefit from the     treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension     study patient will continue treatment of the drug (imatinib or nilotinib) which they are     taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 will be retained. As long     as we get EC approval and agreement from investigators, the selected sites for CAMN107ECN02     will be applied in this extension study.      Patients will be enrolled after eligibility evaluation. During the study, follow-up visits at     a frequency of 6 months are required referring to the core study and recommendation in     Chinese CML guideline. No data collection plan is included in this extension study except     safety data. Investigator will be asked to report AE, SAE and pregnancy in order to ensure     compliance with pharmacovigilance requirement. AE&SAE information will be recorded in CRF and     included in clinical database. In addition, SAE and pregnancy will be reported to Novartis     safety database.      The extension study will start from first patient last dose date in CAMN107ECN02 and end at     the time of nilotinib first line treatment commercially available in China.   "
77399|NCT02272764|"     This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.   "
77400|NCT02272751|"     This study will aim to compare the effects of an Exercise programme and a Relaxation     Intervention in lymphoma patients in remission post-chemotherapy on quality of life,     cardiovascular fitness, exercise tolerance, muscle strength, psychological status, social     well-being and biological markers.      Subjects will be recruited from a specialist lymphoma clinic in South West London and     randomly allocated to an exercise or a relaxation home programme. The study aims to determine     the more effective intervention of the two in relation to the outcome measures.      The investigators anticipate that the interventions will result in less adverse events and     improved quality of life and physical fitness, and subjects will require less medication,     less counseling and cancer nurse specialist care, leading to leading to a reduction in     hospital and surgery attendances.   "
77401|NCT02272738|"     The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus     nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for     unresectable locally advanced pancreatic adenocarcinoma.   "
77402|NCT02272725|"     The specific aim of this study is to evaluate the safety of non-steroidal anti-inflammatory     drugs (NSAIDs) and their impact on renal function and/or contribution to exercise-associated     hyponatremia (EAH) during an ultramarathon foot race. There is currently much debate over     whether NSAID ingestion during endurance events contributes to acute kidney injury. Endurance     events often ignite a perfect storm of physiologic insults- heat stress, dehydration, and     myopathy- which can all negatively impact kidney function. There is a concern that NSAIDs may     further potentiate these negative effects as well as contribute to EAH through its     anti-diuretic affect. To date, no powered, prospective study has ever examined the effects of     NSAIDs on either of these two biochemical outcomes      Ultramarathon endurance events, defined as any race longer than a marathon (26.2 miles), are     increasing in popularity, with a 10% increase in annual participants, and more than 69,000     finishers worldwide in 2013. Considerable literature has documented alterations in serum     biochemical profiles of these endurance athletes, with consistent evidence of elevated serum     creatinine (Cr) levels in healthy race finishers as well as those seeking medical care. While     acute renal failure in ultramarathon runners is a rare occurrence, acute kidney injury is     common, ranging from 34% in a single-stage ultramarathon to 55-80% in multi-stage     ultramarathons. The evidence is equivocal regarding NSAID ingestion and AKI. One study showed     that runners who ingested NSAIDs prior to marathons had greater post-race creatinine levels     than matched controls as well as higher rates of hospitalization and acute renal failure.     However, this contrasts with several other studies that showed a marked lack of difference in     creatinine levels or development of acute kidney injury between NSAID users and non-users     during ultramarathons. The only randomized trial to date on this subject found no difference     in serum creatinine levels between the NSAID and placebo groups at ultramarathon race end,     however conclusions were limited by a small unpowered sample size.      Exercise associated hyponatremia (EAH), defined as a serum sodium concentration below     135mEq/L, is recognized as a relatively common issue in endurance running events. The     incidence of EAH varies depending upon the distance of the race, with reported values of     3-28% for marathons, 23 - 38% for triathlons and 4-51% in single-stage ultramarathons. EAH is     likely under-diagnosed as athletes are often asymptomatic. While EAH most often manifests as     non-specific symptoms such as nausea, vomiting, dizziness, and fatigue, it can be a     potentially fatal disease that can progress to encephalopathy, seizures, pulmonary edema, and     death. There have been no large prospective studies examining the relationship between EAH     and NSAID ingestion.   "
77429|NCT02272374|"     The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of     different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous     graft) in the elderly and very elderly with end-stage renal disease in China.   "
77433|NCT02272322|"     This observational study will evaluate treatment of symptomatic cystocele grade II-III with     Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be     collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of     recurrence.   "
77434|NCT02272309|"     Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the     lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from     0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable     SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in     patients with LUT symptoms during low bladder volume and maximum cystometric capacity to     assess reliability of measurements and influence of potential concomitant LUTS treatments.   "
77497|NCT02271477|"     Aim of this study is to determine whether Inferior Vena Cava analyzed by trans-thoracic     echocardiography is an effective method to guide titrated fluid repletion in non critical     patients, in order both to decrease post procedural significant hypotension rate and to avoid     unnecessary fluid overload in patients undergoing spinal anesthesia for elective surgical     procedures   "
77404|NCT02272699|"     Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell     carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all     cases. One of our phase Ⅱ study introduced a combination treatment of an anti epithelial     growth factor receptor (EGFR) agent, nimotuzumab, with paclitaxel and cisplatin as first-line     treatment in unresectable or metastatic ESCC. The results showed that the overall response     rate was 51.8% (29/56) and disease control rate was 92.9% (52/56). As a median follow-up of     24 months, the median progression-free survival for patients with metastatic disease and     local advanced disease were 8.2 months and more than 23 months respectively. The overall     survival for patients with metastatic disease was 13.9 months. It implied that as first-line     chemotherapy, an addition of nimotuzumab to chemotherapy was a more active treatment option     compared to other regimens published in previous studies. Investigations by Liang, J. and     Ling, Y. also suggested that nimotuzumab in combining with radiotherapy or chemotherapy also     showed anti-tumor activities and limited toxicities.      Therefore, we initiated this phase Ⅱ to Ⅲ clinical trial in which combining neoadjuvant     treatments of nimotuzumab with chemotherapy or nimotuzumab with radiotherapy are compared     with surgery alone for resectable stage Ⅱa to Ⅲ middle and lower thoracic esophageal squamous     cell carcinoma patients. We hope to explore if these neoadjuvant combination treatments could     bring survival benefit for ESCC patients.   "
77405|NCT02272686|"     The goal of this clinical research study is to learn if ibrutinib can help to control     lymphoma in patients who have had an autologous stem cell transplant (a transplant using your     own stem cells). The safety of this drug will also be studied.   "
77406|NCT02272673|"     Febrile neutropenia (FN) is a common and serious side effect of chemotherapy. Current     management of FN is expensive and may induce side effects. Honey is a natural substance     produced by honeybees. It possesses antioxidant, antimicrobial and anticancer effects. In     addition, honey is not expensive. The aim of this study was to evaluate the effects of     12-week honey consumption on children with acute lymphoblastic leukemia (ALL) particularly     with regards of FN episodes. This randomized crossover clinical trial included 40 patients of     both sexes, aged 2.5 to 10 years. They were randomized into two equal groups [intervention to     control (I/C) and control to intervention (C/I)]. The dietary intervention was 12-week honey     consumption in a dose of 2.5g//kg body weight per dose twice weekly.   "
77407|NCT02272660|"     Evaluated the effect of perioperative parecoxib administration on postoperative pain,     analgesic use, function recovery, inflammatory response and bleeding risk.   "
77408|NCT02272647|"     Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal     women. Preliminary data are sought to estimate statistical power for more detailed studies of     this hypothesis.   "
77409|NCT02272634|"     This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy,     3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice     daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary     Disease (COPD) patients.   "
77410|NCT02272621|"     This is a single-center, open-label, randomized controlled trial. Patients scheduled for     aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be     eligible. Twenty patients will be randomly assigned to either partial upper sternotomy (20     patients) or full sternotomy AVR (20 patients). Inclusion criteria is severe aortic stenosis     referred for medically indicated isolated aortic valve replacement. Exclusion criteria are     left ventricular ejection fraction less than 0.45, previous cardiac surgery, or     urgent/emergent surgery.      CE-marked and FDA-approved mechanical and bioprosthetic (stented or sutureless) aortic valves     will be implanted. Cytokine release will be repeatedly assessed preoperatively and     postoperatively (at 0, 6, 12, 18, 24 hours, and 3 days after surgery). Clinical     characteristics will be registered. Clinical postoperative ouytcomes will be registered.     Routine blood sampling will be performed pre- and postoperatively. All available data will be     collected prospectively. Informed consent will be obtained from patients meeting the     inclusion criteria before the initiation of any study-specific procedures.   "
77411|NCT02272608|"     There is some evidence suggesting that OSA is associated with low level of systemic     inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular     damage has been implicated as the underlying mechanism responsible for comorbidities.     Detection of altered inflammatory markers in OSAS patients may predict the degree of     nocturnal sleep disturbance and associated systemic inflammation and presence of     comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte     ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge,     NLR has not been studied in OSAS. We conducted the present study to evaluate the association     between OSAS and inflammatory markers CRP, ESR and NLR.   "
77412|NCT02272595|"     The goal of this laboratory research study is to learn if using molecular information     (matched therapy) or not using molecular information and having the study doctor choose the     therapy based on your past experience are more effective ways to choose the best cancer     treatment for you.   "
77413|NCT02272582|"     A prospective randomized, double-blinded, comparative within-person study to evaluate the use     of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.   "
77414|NCT02272569|"     Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy     of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.   "
77415|NCT02272556|"     Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure     intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of     hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess     cerebrospinal fluid levels of metabolites.   "
77416|NCT02272543|"     Protein-energy malnutrition (PEM) including moderate acute malnutrition (MAM:     weight-for-height z-score <-2 to -3, or mid upper arm circumference (MUAC) 115 to < 125 mm)     is a major cause of morbidity and mortality in under-5 children of developing/low-income     countries. Approximately 14.6% of all under-5 mortality worldwide is attributed to MAM.     Prevalence of MAM among under-5 children in Bangladesh is ~12% (~1.7 million). Providing a     diet containing adequate nutrients is the mainstay of treatment of children with MAM. Dietary     protein is mostly derived from vegetable sources for the middle and low income population     among whom the prevalence of MAM and other forms of PEM is high. It is now possible to     process fish into fish peptides with longer shelf-life without refrigerator, known as 'fish     Surimi' and consumed by different categories of people who need more well-balanced protein;     this could be an attractive alternative to supply fish protein in the diet of children in     low-income countries like Bangladesh.      Fish Surimi peptide is broken down from white fish meat using plant-derived enzyme and the     ingredient is just fish meat consisted of 20 different kinds of amino acids including nine     essential amino acids. In human studies it is found to help lowering blood lipids, glucose,     IgE, hypertension, and increasing serum albumin and total protein, and bone density.      The present study is designed to assess acceptability and efficacy of 'fish Surimi' in 2-5     years old children suffering from MAM. A pilot study with two phases: to assess the i)     acceptability with a small convenience sample (N=30) (phase 1); and ii) efficacy (rate of     weight gain) of this fish peptide in a small convenience sample (N=70: 35 intervention 35     control) (phase 2) is proposed.      Acceptability trial (first phase): The investigators will conduct this study in the study     ward of Dhaka Hospital of icddr,b. For each child the study will be for two days: i.e. direct     observation of food intake of two lunches and two suppers. In a randomly manner and cross     over design, an individual child will be offered 5g of fish Surimi during lunch and 5g during     supper in one day or the same meal without any fish peptide on the other day in a blinded     manner. The investigators will observe the completeness and eagerness of eating and any     possible side effect (e.g. allergy, vomiting, diarrhea etc.) over these two days.      Pilot efficacy trial (second phase): The investigators will conduct a pilot trial to assess     the efficacy (mainly on child weight gain) of fish Surimi given at home with various     foods/meals in 2-5 years old children with MAM will be conducted in Dhaka City of Bangladesh.     Children will be enrolled from the Dhaka Hospital of icddr,b after improvement of any acute     illness. The intervention group will receive (as take home supplementation) two-week's ration     of fish Surimi (@10g/day in two doses i.e. 5g + 5g each in airtight packet), which will be     served twice daily mixed with family diet. The control group will not be provided any     supplements but the parents will be given dietary advice to provide nutritious food to the     child in adequate amounts, and children of both groups will receive micronutrient sprinkle.     The child's guardian will be supplied with fish Surimi during initial discharge from icddr,b     hospital and requested to come for a fortnightly follow up at the nutrition follow-up unit     (NFU) of icddr,b. During each follow-up visit the study research assistant/health worker will     do the anthropometry, collect morbidity history since the last visit/follow up and dietary     history will also be taken to find out how the child is doing along with the fish Surimi     intake. Treatment of any illness will be provided as per standard method by on duty physician     of the Dhaka Hospital of icddr,b. The ration for next two weeks will be provided and in such     way each child will be followed for ~ 3 months over six NFU-follow-up visits. To reduce the     possible drop-out the both-way transportation cost (~ 150 to 250 taka) during each follow-up     visit will be reimbursed to the guardians. In the middle of the two scheduled follow-up days     the research assistant will call the family by cell phone to monitor the child's feeding and     morbidity status. Approximately 5ml blood will be collected from the ante-cubital vein of the     children for biochemical test on enrolment and at the end of 3 months and will be analyzed     for haemoglobin (Hb), c-reactive protein, zinc, ferritin, albumin, total protein, and IgE.     During the blood drawing days each child will be given a toy (take home).   "
77417|NCT02272530|"     The aim of this study is to investigate wether change in endothelial nitric oxid synthase of     blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on     development and progression of cardiovascular diseases.   "
77418|NCT02272517|"     This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major     depressive disorder (MDD) patients with inadequate response to current antidepressant     treatment.   "
81897|NCT02214004|"     The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and     safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive     and HER2-positive breast cancer.   "
77421|NCT02272478|"     AML 18 is the replacement trial for AML16 intensive. This 1600 patient trial is primarily     designed for patients over the age of 60 who are considered fit enough for an intensive     chemotherapy approach and will aim to test the effects of adding 1 of 2 new treatment agents     to commonly used chemotherapy combinations in order to improve patient survival and treatment     regimes.      The AML18 Trial is available to any patient who has primary or secondary AML as defined by     the WHO Classification (excluding Acute Promyelocytic Leukaemia), or high risk     Myelodysplastic Syndrome (i.e. >10% marrow blasts) over the age of 60.      AML18 is a randomised controlled Phase III trial using a factorial design for maximum     efficiency to evaluate two induction options followed by treatment with a small molecule post     course 1 and dose intensification for suitable patients.      There are four randomisation comparisons within the trial:      The first randomisation will compare standard the chemotherapy schedule Daunorubicin/AraC     (DA) combined with 1 or 2 doses of Mylotarg in course 1. Patients not suitable to receive     Mylotarg may have DA alone. Following recovery from course 1 patients who fail to achieve CR     or are MRD positive by centralised flow cytometry will be randomised to one of three options,     either DA chemotherapy, DA chemotherapy plus Cladribine or Flag Ida for up to 2 courses of     therapy.      Patients who achieve CR after course 1 will be randomised to 1 or 2 further courses of DA     chemotherapy.      At course 2 all patients will also enter a randomisation to receive AC220 versus no AC220     with or without maintenance, or Ganetespib verses no Ganetespib for a maximum of 3 cycles.     Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable     HLA matched donor is available.   "
77422|NCT02272465|"     The Prehospital Resuscitation On Helicopter Study (PROHS) is a pragmatic, multicenter,     prospective observational study of air ambulance-based prehospital resuscitation regimens     currently utilized at the participating sites. Patients will be enrolled at participating     sites that currently have blood products available on air ambulances and other sites that do     not. This study will not change the current prehospital standard of care for resuscitation.     The primary outcome will be in-hospital mortality and the primary unit of analysis will be     the patient. Other outcomes of interest will include time to hemostasis, hospital     length-of-stay, number of ventilator-free and ICU-free days, incidence of major surgical     procedures, complications (transfusion-related acute lung injury [TRALI], acute kidney injury     [AKI], multiple organ failure [MOF], acute respiratory distress syndrome [ARDS], sepsis,     intra-abdominal complications, thromboembolic complications, compartment syndromes),     lifesaving interventions, the amount and type of blood products and concentrates transfused     (including prehospital), wastage of prehospital blood products and concentrates, use of     external and internal hemostatic devices, and functional status at discharge/discharge     destination.   "
77423|NCT02272452|"     The main ambition of this project is to develop, and provide the medical community, an     innovative method to analyze extemporaneously, during a neurosurgery operation, excised     tissues. This method is based on the analysis of the metabolic profile of excised tissues by     the technique of High-Resolution Magic-Angle Spinning (HR-MAS) Nuclear Magnetic Resonance     (NMR) spectroscopy. Indeed HRMAS NMR method can provide in a sufficiently short time lapse     (currently about 30 minutes but within our project a time lapse of 15 min or even less is     ultimately intended), medical information that can complement those obtained by classic     histological examination.      Primary purpose:      The main objective of this study is to determine the sensitivity of HRMAS NMR spectroscopy in     detecting residual tumor infiltration at the brain resection cavity. The investigators aim to     determine the relevance of the metabolic analysis compared to histological analysis during a     neurosurgery operation. This involves analyzing excised tissue samples, obtained from the     operating rooms of Strasbourg University Hospitals, and Colmar Hospital Center, with no     return to neurosurgeon for surgery.      Secondary purposes:      The secondary objectives of the protocol are to investigate the metabolome of different types     of brain tumors, in order to find prognostic and diagnostic markers. It consists in detecting     metabolomic factors of bad prognosis, and potential marker of good prognosis such as the IDH     mutation.   "
77424|NCT02272439|"     The overall objective of this study is to determine whether serum BPA and/or phthalate     concentrations differ in fertile versus infertile men and women in Saskatchewan. The     investigators will test the following hypothesis:        1. Serum BPA and/or phthalate concentrations will be greater in women with unexplained          infertility or PCOS compared to a control group        2. Serum BPA and/or phthalate concentrations will be greater in men with male factor          infertility compared to a control group   "
77425|NCT02272426|"     It is estimated that 2 out of 3 patients with a stroke have some problems with their memory,     difficulties performing certain tasks, making decisions and learning new things. In addition,     many stroke patients do not get regular exercise and are often sedentary. Both physical and     cognitive exercise have the potential to improve quality of life, cognition, and overall     health, but the safety and tolerability of such interventions is not clear in stroke     patients. The investigators will examine these outcomes by allocating stroke survivor     participants to one of two groups: a combined exercise and cognitive training program and a     sham control group.   "
77426|NCT02272413|"     The objective of this phase III trial is to establish statistical equivalence in terms of     efficacy (best overall response rate [ORR], proportion of patients with complete response     [CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus     chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with     either BI 695502 or Avastin®.   "
77427|NCT02272400|"     Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1]     No type I or II evidence is currently available to demonstrate equivalence to standard whole     breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG     (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast     radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the     results of this or similar trials are available, PBI remains a research domain, and it should     be offered to patients only in the context of a clinical experimental protocol.   "
77428|NCT02272387|"     Our primary aim is to evaluate whether Vitamin D deficiency causes depressive symptoms in     antepartum and postpartum depression and whether early correction of Vitamin D deficiency     improves these symptoms.      Our secondary aims evaluate maternal and fetal outcomes including antepartum, intrapartum,     and immediate postpartum complications. We are also evaluating the effectiveness of a common     vitamin D treatment regimen used outside of pregnancy.   "
77435|NCT02272296|"     Using a specific jet injector for the administration of a rapid-acting insulin analogue has     been shown to advance the absorption of insulin from the subcutaneous area into the     bloodstream by 40-50%, when compared to conventional injection by insulin pens. The     reproducibility of the jet stream method has not been previously determined in vivo. It is     also unknown how the efficacy of injecting regular insulin by jet stream compares to that of     rapid-acting analogues injected by conventional pen.      Objectives: 1. To compare the pharmacologic reproducibility of the rapid-acting insulin     analogue aspart (Novorapid®) injected by jet-injection to that of the same insulin injected     with a conventional pen. 2. To compare pharmacokinetic and -dynamic profile of regular     insulin injected by jet injection to that of aspart insulin injected by conventional pen.      Study design: Double-blind double-dummy randomized controlled parallel/cross-over   "
77436|NCT02272283|"     Coronary artery disease is one of the most prevalent diseases in the western countries.      A waxy substance called plaque can build up inside the coronary arteries. Over time, plaque     can harden or rupture, and cause narrowing (stenosis) of the arteries and reduce the flow of     oxygen-rich blood to the heart.      The standard treatment of symptomatic coronary stenosis is percutaneous coronary intervention     (PCI) with balloon dilation followed by stent implantation.      A stent is a small metallic grid that stabilizes the coronary vessel wall after the balloon     dilation.      Currently, drug-eluting stents (DES) are the most widely used stent types. DESs consist of a     metallic backbone and an antiprolifetive drug-coating bound by a polymer (glue). These     devices have reduced the incidence of excessive formation of new tissue (in-stent restenosis)     dramatically in comparison with previously used bare-metal stents.      However, there are safety concerns with DES, since later thrombotic events have been     reported.      On one hand excessive tissue formation inside the stent can cause in-stent restenosis, and on     the other hand insufficient coverage of the stent can cause persistently exposed metalllic     material that can induce platelet aggregation and thrombus-formation.      The etiology to stent thrombosis is multifactorial. Possible predisposing factors are, among     others: 1) hypersensitivity towards the polymer-coating, which may induce delayed healing     inside and around the stent, and 2) insufficient contact between the stent and the underlying     coronary vessel wall (incomplete stent apposition), which may cause flow-disturbance and     delayed healing.      Delayed healing causes persistently exposed metallic material that can induce platelet     aggregation and thrombus-formation.      The Nobori stent is a new-generation DES, coated with a thin layer of drug and a     bioabsorbable polymer. The drug is localized on the outer side of the stent, and decreases     the release of drug to the blood circulation. The bioabsorbable polymer is degraded after 6-9     months after implantation, and decreases the risk of hypersensitivity-reactions in the vessel     wall.      The improved pharmacokinetic profile of the stent is thought to improve the healing pattern.      At routine coronary angiography, a small plastic tube is inserted in the femoral artery under     local anesthesia. Thin, flexible catheters are then advanced through the artery system     (femoral artery and aorta) to the coronary arteries. Contrast is injected in to the blood     stream by the catheters, and the arteries are depicted by a special X-ray technique during     dye-release. By angiography, the outer sides of the coronary arteries are visualized, and     balloon dilations and stent implantations are guided by this standard technique.      Newer studies have documented that stent placement and expansion is superiorly visualized if     supplementary intravascular imaging is performed during stent implantation.      Small imaging catheters are wired through the vessel after stent implantation, and film the     stent retrogradely through the vessel.      Intravascular ultrasound (IVUS) visualizes the complete vessel wall by use of sound waves,     and stent expansion is evaluated in detail.      Optical coherence tomography (OCT) is a newer light-based, high-resolution technology. The     technique can depict every thread (strut) from the stent, enabling visualization of both     contact between struts and underlying vessel wall immediately after the procedure, and strut     coverage at follow-up.      The purpose of this study is to determine whether OCT-guided PCI can improve healing and     coverage of the stent in comparison with routine angiographic guidance alone in patients     indicating PCI due to myocardial infarction.      If OCT-guidance improves coverage of the stent, this might lower the later thrombotic risk.      Patients hospitalized due to myocardial infarction are randomized either to OCT-guided or     angio-guided stent implantation in the present study. In both groups the Nobori stent is     implanted according to standard techniques. In the angio-guided group, implantations are     guided by angiography alone. OCT- and IVUS analysis are performed after an angiographic     optimal result for documentary reasons. The operator is blinded towards the image findings,     and analysis is performed offline later.      In the OCT-guided group, both OCT and IVUS analysis is interpreted immediately after the     acquisition. If stent apposition and/or expansion is deemed suboptimal, additional balloon     dilation and/or stenting is performed. In case of OCT-driven stent optimization, a     documentary OCT and IVUS is performed to document the final result.      Patients are readmitted 6 months later for a control angiogram inclusive OCT to assess stent     coverage.      Furthermore, patients are readmitted 12 months after the index procedure for a control     angiogram including OCT and IVUS to assess dynamic vessel wall responses.   "
77437|NCT02272270|"     This will be an open label, single arm study. Subjects with newly diagnosed high grade glioma     will begin minocycline one week prior to beginning postoperative chemoradiation and continue     it until progression, intolerance, or the end of adjuvant temozolomide, whichever comes     first.   "
77438|NCT02272257|"     The purpose of this study is to determine whether seeing a physical therapist first compared     with seeing a physician first is more clinically and cost effective in an occupational     setting for acute musculoskeletal conditions.   "
77439|NCT02272244|"     This study is designed to test a standard mailed intervention (SI) versus a novel decision     support and navigation intervention (DSNI). Working with patients and stakeholders, this     randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age,     patients in community based primary care practices, and are eligible for CRC screening. We     will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI     Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on     overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC     screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific     CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and     knowledge and perceptions.   "
77440|NCT02272231|"     The objectives of this study are to: (1) use cultivation-independent molecular methods to     determine the sequence of microbiological events culminating in bacterial vaginosis (BV)     among sexually active African American women who have sex with women (AAWSW) and (2)     determine if specific Gardnerella vaginalis oligotypes are associated with the development of     BV among sexually active AAWSW.   "
77441|NCT02272218|"     The primary purpose of this study is to evaluate laparoscopic gastric banding (LAGB) surgery     as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory     to medical treatment. The primary outcome will be the reduction in OA-related pain and     disability after LAGB.   "
77465|NCT02271893|"     The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a     decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced     peripheral neuropathy compared to placebo group.   "
77466|NCT02271880|"     Investigates whether a family-based intervention for adolescents with Attention Deficit     Hyperactivity Disorder (ADHD) will improve adherence to prescribed medication regimen in     adolescents with history of medication nonadherence.   "
77442|NCT02272205|"     Infection is a serious complications after undergoing total hip replacement. It occurs in     about 1% of cases. The optimal treatment of these infections is discussed. The team validated     by international publications change strategy of the infected prosthesis at a time.      Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination     in orthopedic surgery rates. It must be conventionally administered before the surgical     incision. In response to infection, it is typically recommended to start this antibiotic     after the completion of the deep bacteriological samples, so as not to negate the risk of     these samples by the prior administration of antibiotics. This attitude, however, is not     formally validated by the scientific literature. In contrast, two recent publications     challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in     septic interventions. Our multidisciplinary team opted for a few months for this new     strategy. We wish to evaluate the influence of this new approach results in the treatment of     infection in total hip or knee.   "
77443|NCT02272192|"     A multi-site randomized study of intensive treatment for toddlers with autism. This project     proposes a three-site collaborative network plus a data coordinating center to evaluate the     effects of intervention intensity and intervention style delivered for 12 months, on the     developmental quotients (primary outcome) of very young children with ASD ages 12-30 months     old and their families, and the effect of children's initial vocal skills, developmental     rates and autism severity on their response to intervention. A second study will examine     whether the effects of the Early Start Denver Model intervention are sustained over a three     year period for 6-7 year old children who previously were enrolled in a two year study that     compared ESDM treatment to usual community interventions.   "
77444|NCT02272179|"     Adolescent suicide is the 3rd leading cause of death in this age group. There are no     validated treatments to decrease the risk of adolescent suicidal behavior, and there are     especially no interventions to target the highest risk period for adolescent suicide and     suicidal behavior, namely during the time of transition from inpatient to outpatient care.     This project aims to develop a novel, brief intervention that can be delivered on an     inpatient unit prior to the transition to outpatient care, will augment known factors to     protect adolescents from suicidal behavior, and will extend the impact of treatment by     liaison with the outpatient therapist and the development of a personalized safety plan phone     application. This treatment, ASAP, focuses on augmenting Adherence to the components of ASAP     and outpatient aftercare, development of a personalized Safety Plan, and Affect Protection,     through helping the teen and family promote a positive mood, achieve healthy sleep habits,     maintain sobriety, and access social support.   "
77457|NCT02271997|"     Multicentre randomized controlled trial to evaluate the optimal treatment for patients who     developed an iron deficiency after Roux-en-Y Gastric bypass.   "
77458|NCT02271984|"     This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The     purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ     [MSC2499550A]) oral dispersible tablet (ODT) formulation (150 mg) versus the current marketed     praziquantel (PZQ) (cysticide® 500 mg) formulation in healthy male volunteers.   "
77445|NCT02272166|"     Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover,     this aspect of post-operative period is often required for discharging patients from hospital     after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score)     whose validation evaluates patient's ability to return home.      The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic     effect of propofol compared to halogenated gases. These studies had neither the power nor the     methodology to answer the question. The aim of our study is to evaluate the impact of     propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.   "
77446|NCT02272153|"     The satiety effects of the combination of protein and fiber within egg and whole grain     breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating     than low protein, low fiber.   "
77447|NCT02272140|"     The objective of this study is to evaluate the utility of localized stimulation of the     lumbosacral nerve roots during XLIF through correlation of observed changes in the response     latency, amplitude, waveform morphology, and/or response threshold with surgical events.     Additionally, correlation between neuromonitoring findings and postoperative neural status     will be evaluated.   "
77448|NCT02272127|"     Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor     (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine     kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment     with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is     still under investigated. This study aims to observe and compare the efficacy and safety of     intercalated combination of chemotherapy plus icotinib in patients undergoing resection of     EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.   "
77449|NCT02272101|"     A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic     rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms and     rhinitis related quality of life.   "
77450|NCT02272088|"     The main purpose of this study is evaluate the effect of different intensities of exercise     (moderate vs. intense) on the daily energy expenditure in overweight adolescents.   "
77451|NCT02272075|"     This trial will compare images obtained from a mobile colposcope with those obtained using a     standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded     images will be evaluated be experts in colpsocopy and compared   "
77452|NCT02272062|"     Selection of a treatment strategy for patients with symptoms due to coronary artery disease     requires consideration of patient preferences. In current clinical practice, patient     preferences for treatment may not be known prior to diagnostic coronary angiography. The     investigators will test an internet-based shared decision-making tool which will provide     education and solicit preference information prior to angiography. The investigators seek to     determine if this tool can accurately assess patient preferences, and if these preferences     will lead to a change in clinical management.   "
77453|NCT02272049|"     The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas     MRI for regional assessment of lung function in a normal population of children and adults     and in adults and also in children with respiratory compromise due to a variety of diseases.   "
77454|NCT02272036|"     The purpose of this study is to analyze if integration of new media (SMS) could improve the     quality of colonoscopy preparation.   "
77541|NCT02270892|"     Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera®     treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the     last treatment. Study images will be obtained pre-treatment, immediately post-treatment, and     at each follow-up visit.   "
77455|NCT02272023|"     A Phase II Randomized Clinical Trial (RCT) is proposed to compare a 9-session model of     intensive motivational interviewing (IMI) to standard motivational interviewing techniques     (SMI) among alcohol dependent women. Preliminary work studying 87 women randomly assigned to     IMI or a standard single session of motivational interviewing showed significantly better     drinking outcomes for women in the IMI condition at 4- and 6-month follow-up. Interestingly,     mean trajectories for women assigned to IMI showed continuing declines in drinking problems     during and after treatment. Differences between study conditions grew larger between 4-month     (p<.05) and 6-month (p<.01) follow-up and the effect size at 6 months was medium to large     (Cohen's d=0.63) The study will use mixed model quantitative and qualitative methods to     respond to the PA's call for studies assessing mechanisms of change. Unlike many previous     studies of SMI, we will employ limited exclusion criteria and will enroll participants who     present with co-existing drug and psychiatric disorders.      Procedures for the proposed study draw from our current successful RCT assessing IMI for     methamphetamine (MA) dependence. Successful aspects of the current study include achievement     of recruitment goals, strong adherence to the treatment and research protocols, and excellent     rates for follow-up interviews (>90%). The proposed study will take place at the same     outpatient treatment program as the current study, New Leaf Treatment Center in Lafayette,     California.      Participants will include 220 alcohol dependent women who will be randomly assigned to IMI or     SMI. Those in SMI will also receive an attention component (nutrition education) to achieve     time equivalence between the two study conditions. Participants in both groups will receive     standard weekly group treatment offered at the program. In addition, referrals to Alcoholics     Anonymous will be provided to all participants. The primary outcomes will be measures of     drinking, heavy drinking (4+ drinks), and severity of alcohol problems assessed at baseline     and 2, 6, and 12 months. Secondary outcomes will include Addiction Severity Index scales,     psychiatric problems, and symptoms of trauma. The study will include standard quantitative     testing of potential mediators, including, the therapeutic alliance, self-efficacy,     motivation, satisfaction, and use of outside services. However, the application also proposes     an innovative use of qualitative procedures to identify unrecognized factors influencing     outcome.   "
77456|NCT02272010|"     Bipolar disorder (BD) is a chronic, often disabling illness, and many individuals remain     symptomatic despite pharmacotherapy. Significant mood variability often persists throughout     the lifespan and predicts relapse, leading to functional impairment. Metabolism of dietary     essential polyunsaturated fatty acids has been shown to be upstream of the neuroinflammatory     processes that may lead to neurotoxicity and chronicity of illness in BD. The investigators     hypothesize that an intervention diet designed to alter intake of polyunsaturated fatty acids     that augments mood stabilizing medications will reduce inflammation; and that the reduction     of inflammation will reduce mood variability in bipolar disorder. After a two-the     investigatorsek baseline-monitoring period, the investigators will randomize individuals with     BD to an intervention or a control diet. Mood will be measured daily using a smartphone.     Phase 2 will consist of 12 the investigatorseks of a less intense intervention. Follow-up     will then be completed at 6, 9, and 12 months post-baseline to assess for recurrence of mood     episodes. By maintaining a certain diet in addition to taking mood-stabilizing medication,     researchers hope to see whether specific dietary plans have any bearing on mood variability.   "
77461|NCT02271945|"     This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680     (AMP-514) in participants with relapsed or refractory aggressive B-cell lymphomas who have     failed 1-2 prior lines of therapy.      The primary objectives are to determine the maximum tolerated dose (MTD) or highest     protocol-defined dose (HPDD); in the absence of exceeding the MTD of MEDI-551 in combination     with MEDI0680 (AMP-514); and to evaluate the safety, tolerability, and clinical activity of     MEDI-551 in combination with MEDI0680 (AMP-514).   "
77462|NCT02271932|"     A successful non-operative management strategy for early appendicitis will decrease the     number of children requiring surgery and may improve the quality of care related to the     treatment of appendicitis. To account for the child-family perspective and treatment     preferences, the investigators will perform a study in which patients and their families     choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten     U.S. hospitals. This study will determine the effectiveness of non-operative management of     early appendicitis with antibiotics alone in children and compare differences in morbidity,     disability, quality of life, satisfaction, and cost between families choosing surgery or     non-operative management.   "
77463|NCT02271919|"     Objectives:      The goal of this clinical research study is to test two therapies that may help people quit     smoking to determine if one is more effective than the other. The two therapies are Chantix     (varenicline) and a combination of a nicotine patch and nicotine lozenge. For subjects who     have not achieved smoking abstinence after 6 weeks, the objective is to determine if it is     more effective to continue with the same therapy, change the therapy or augment the current     therapy with an increased dose.      Aim 1: To estimate the main effects of varenicline 2mg (VAR) and nicotine patch + lozenge     (NPL) on smokers who remain on these medications throughout the trial.      Aim 2: To estimate the probability that abstinence at twelve weeks as a function of treatment     assignment at six weeks (augmentation) is moderated by initial treatment assignment (i.e. at     baseline).      Aim 3: To estimate the probability that abstinence at twelve weeks as a function of treatment     assignment at six weeks (switching) is moderated by initial treatment assignment (i.e. at     baseline).      Aim 4: To estimate the probability that treatment continuation, switching, or augmentation     confers benefit conditional upon failing to quit after the initial treatment with nicotine     patch + lozenge (NPL) for six weeks.      Aim 5: To estimate the probability that treatment continuation, switching, or augmentation     confers benefit conditional upon failing to quit after initial treatment with VAR for six     weeks.   "
77464|NCT02271906|"     The goal of this clinical research study is to learn if it is tolerable for patients with     NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.   "
77467|NCT02271867|"     Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in     a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve     block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic     solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at     investigating, in a quantitative way, the block characteristics of 3 different commonly used     local anesthetics on peripheral nerves through the application of thermal QST by measuring     changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be     of value for measuring gradual changes in block characteristics on the adjacent nerves at     distance of the injection site in an US-ISB.   "
77468|NCT02271854|"     This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction     of the pain associated with DOMS   "
77469|NCT02271841|"     This study evaluated the practice before and after the introduction of a particular model     pulsoxymeter giving, in addition, information on the state of fluid responsiveness of the     patient.   "
77470|NCT02271828|"     STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the     axilla, in order to positively influence the axillary morbidity rate and quality of life.      PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not     inferior to the current axillary staging regimen in clinically node negative breast cancer     patients undergoing breast conserving therapy, in terms of regional recurrence rate.      HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node     negative breast cancer patients undergoing breast conserving therapy. This will lead to a     decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease     free- and overall survival rates.   "
77471|NCT02271815|"     There is a need for toothpastes that more effectively remove oral biofilm, and inhibit     biofilm re-formation. This is particularly important for patients with long-term orthodontic     fixtures or prosthodontic appliances, and also for debilitated, diabetic and     immunocompromised patients. The objective of this study is to evaluate the effects of     toothpastes on plaque presence and removal, dental hard tissue mineralization, erosion,     abrasion and microstructure as well as gingival and periodontal health and dry/sore mouth. In     addition to clinical scoring and photographs, measurements of tooth and gum sensitivity,     saliva volume, pH and buffering, variables may be evaluated using tooth samples worn on     removable dental retainers. These samples will be examined outside of the mouth using     advanced optical techniques such as Optical Coherence Tomography (OCT), Fluorescence, various     forms of microscopy and spectroscopy.   "
77472|NCT02271802|"     In this placebo-controlled randomized parallel study the effects of a butyrate enema on     plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera,     liver and the splanchnic area are investigated   "
77473|NCT02271789|"     The purpose of this research study is to find a new way of using light to measure the blood     flow within the tooth.      The researcher develop dental Laser Speckle imaging system tool that can use for exam     condition of the tooth. This device is reliable method to provide information to dentists and     endodontists during oral examination.   "
77474|NCT02271776|"     Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern     high in acetate and that this will lead to beneficial effects on human substrate and energy     metabolism, we aim to address the following primary objective:      To investigate the effects of a 12-week supplementation of GOS on peripheral insulin     sensitivity and body weight control in obese adults with impaired glucose homeostasis.   "
77475|NCT02271763|"     The investigators will be comparing a traditional palpation (feeling) technique with an     ultrasound technique for finding a specific part of the neck.   "
77476|NCT02271750|"     The global prevalence of dementia is close to 36 million (2010). Furthermore the number is     predicted to double in the next 20 years, primarily due to the demographic ageing. A     perspective that will challenge the current healthcare systems and national economies.      Dementia is characterized by progressive deterioration in cognition, function and behavior     that is sufficiently severe to compromise social and occupational functioning.      The pathogenesis of dementia remains elusive. Thus, there is a need to increase our     understanding of the mechanisms leading to the most common forms of dementia. A better     understanding of the disease may enable an earlier diagnosis and importantly, a causal     treatment of Alzheimer as opposed to the merely symptomatic options available to day.      An experiment with rats and memory might already have taken the first step towards this. The     experiment has demonstrated that administration of IGF-II to rats significantly enhances     memory retention and prevents forgetting. Furthermore inhibitory avoidance learning leads to     an increase in the hippocampal expression of IGF-II. Finally, yet importantly, injections of     recombinant IGF-II into hippocampus after training or memory retrieval significantly enhance     memory retention and prevent forgetting.      The spinal fluid and the serum will be analysed at the Medical Research Laboratory. The     immunological concentrations of IGF-I and -II are measured by validated in-house analyses.     Furthermore, Aarhus University Hospital has a unique technique, whereby it is possible to     measure the bioactivity of IGF-I and -II in the cerebrospinal fluid. The concentrations of     NGF, BDNF and sCD-163 in spinal fluid and serum will be analysed by already established     techniques.      The purpose of this study is therefore to define the concentration and biological activity of     IGF-I, IGF-II, BDNF, NGF and sCD-163 in the cerebrospinal fluid and serum in patients with     Alzheimer's compared with controls.   "
77477|NCT02271737|"     Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in     maternal and under five year old mortality. Evidence exists that a large proportion of     newborn mortality globally and in Cambodia is attributable to infections and sepsis. The     study proposes a package intervention to address infection control in the perinatal period in     facilities and to improve the timeliness of referral of newborns with suspected infections to     appropriate health facilities for treatment through upgrading of hygiene practices in     facilities and linking of community based volunteers with health facilities and families in     the community setting.      By delivering a coordinated intervention that combines improved education for health center     midwives, village health care workers, and mothers of newborns, along with improved care     coordination with increase in number of interactions (points of contact) between mothers and     health care personnel, the investigators will see improved knowledge of newborn danger signs     among mothers and health care workers, more rapid case detection of significant newborn     illnesses, and more rapid and appropriate referral of ill newborns.      The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are     different from those reported in Western cultures, and that Staphylococcus aureus will be a     common pathogen as described in neighboring Laos. The investigators will evaluate the causes     of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.   "
80535|NCT02231775|"     The goal of this clinical research study is to compare receiving the combination of     dabrafenib and trametinib before surgery to having surgery alone in patients with melanoma.     The safety of the study drug combination will also be studied.   "
77478|NCT02271724|"     Chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy     (MMN) are characterized by progressive deterioration in muscle strength, loss of sensibility,     diminished or absent reflexes and impaired fine motor control. Often it is caused by     demyelination which is suitable for treatment but damage to the axons may also occur     especially in case of insufficient treatment.      CIDP and MMN are immune mediated neuropathies in which first choice of treatment is     intravenous immunoglobulin (IVIG), although the mechanisms underlying the effect of the IVIG     is not yet clarified.      The patients are diagnosed by electrophysiological examination and elevated level of protein     in the cerebrospinal fluid. The diagnosis may be difficult to make due to great clinical     variation and insensitive examinations methods including lack of biomarkers.      The purpose of this study is to define if patients treated with SCIG and IVIG for CIDP and     MMN have higher concentrations of sCD163 and CD19 in their cerebrospinal fluid and serum     compared with symptomatic control subjects and is related to disease severity. Furthermore it     is to define if patients newly diagnosed with CIDP or MMN have higher levels of sCD163 and     CD19, than patients treated regularly with SCIG and IVIG.   "
77479|NCT02271711|"     The goal of this clinical research study is to learn if infusions of a particular type of     patients' own white blood cells called natural killer (NK) cells can reliably and safely be     given to patients with brain tumors after the cells have been through a procedure to expand     (increase) their numbers.      Researchers also want to learn if NK cells infused through the ommaya reservoir can help to     control the disease in patients with advanced brain tumors. The ommaya reservoir is a     catheter system through which NK cells will be infused directly into areas of the brain     called the fourth ventricle or the lateral.      This is the first study of NK cells infused into the fourth ventricle of the brain in humans.   "
77480|NCT02271698|"     The purpose of the study is three fold. First to determine the ideal dose of dexamethasone     intraoperatively that will reduce acute pain and opioid consumption. Second determine if     dexamethasone at the time of surgery reduces chronic pain following total knee arthroplasty     and finally determine if a pro-inflammatory environment makes patients susceptible to chronic     pain after surgery and can dexamethasone alter this environment. Patients undergoing total     knee arthroplasty will be randomized to four groups ( 0mg, 6mg, 12mg and 24mg dexamethasone)     and assessments will be made of acute and chronic pain and quality of life measures. Blood     samples will be drawn to assess Interleukin levels and for Macrophage sorting. For the     primary efficacy endpoint of reduction of opioid consumption over 24 hours after surgery the     dexamethasone regimen group will be compared to standard of care group using t-test. For     comparisons of the secondary efficacy endpoints, t-test, Chi-square test and Fisher's Exact     test will be used. Risks of this study include the risks of venipuncture and intravenous     dexamethasone administration.   "
77481|NCT02271685|"     Participants will be assigned to complete computerized estimation tasks for which there is a     component of accuracy, such as estimating the duration of sounds. Participants will be told     that the task is used as an early diagnostic tool to detect those at risk for a medical     condition (e.g., Parkinson's disease, Alzheimer's disease). Instructions will be given to     participants telling them that accuracy on the task is associated with the disease, whereas     those who are not at risk of the disease tend to either overestimate or underestimate the     duration of the sounds. The investigators examine whether such instructions about the purpose     and diagnosticity of the tasks biases participants' responses to the tasks, leading them to     purposefully be more inaccurate in their estimates.   "
77482|NCT02271672|"     This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive     temporary reduction of waist circumference by disruption of adipocyte cells.   "
77484|NCT02271646|"     Patients undergo percutaneous radiofrequency ablation of hepatic tumors at Siriraj hospital     normally receive only intravenous sedative drugs which sometimes can not provide effective     pain control.      TPVB is suitable for unilateral operations. And it is increasing popular nowadays because of     using ultrasound guided which make it is more reliable and has less side effects especially     the severe one such as pneumothorax. To cover all nerve supply liver, we decided to use right     TPVB at T5-6, T7-8, and T9-10.      The aim of this study is to prove that TPVB can provide an effective pain control for     patients undergo liver RFA both at rest and movement (cough). We are going to measure the     pain score at recovery room and the effective pain control means patients has mild pain (pain     score less </= 3 and do not ask for analgesic drugs).   "
77485|NCT02271633|"     The main aim of the current study will be to compare the effects of ingesting different     nitrate-rich sources on plasma nitrite concentrations.   "
77486|NCT02271620|"     -  To determine prevalence of local allergic rhinitis (LAR)        -  To evaluate clinical characteristic and severity of local allergic rhinitis        -  To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus (Dp)          after nasal allergen provocation test (NAPT)   "
77487|NCT02271607|"     This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of     moxibustion therapy on overactive bladder (OAB) patients.   "
77488|NCT02271594|"     The investigators intend to assess the impact of optimized injection technique on the     evolution of clinical parameters in insulin-treated patients with diabetes (DM) who have     clinical lipohypertrophy (LH) in a controlled, prospective study with a follow-up of 6     months, conducted at Ealing Hospital, West London, UK. DM patients who have LH and inject     into it will be randomized to either switch to normal tissue sites with intensive education     as to why and how and use of a 4mm pen needle, or to continue with standard care. The     endpoints measured will include the impact on glucose control parameters, consumption of     insulin, hypoglycaemia rates, use of health services resources and health care costs   "
77537|NCT02270944|"     The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to     40 years of age the safety and immunogenicity of a liquid formulation of Group B     Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration),     and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and     pregnant women in the clinical development program to date.   "
77489|NCT02271581|"     There is a growing body of evidence that implicates inflammation as a mechanism of disease     progression and reduced survival in patients with advanced cancer. Elevated c-reactive     protein levels have been shown to be associated with reduced performance status, specific     cancer related symptoms and reduced overall survival. C-reactive protein levels are a     surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer     recurrence. VeriStrat® is a multivariate test which measures protein expression related to a     host/tumor interaction mediated by inflammation. The investigators hope to examine the     relationship between quality of life outcomes per FACT-L survey and correlate them with     changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study     is that the remarkable survival benefit in the Temel study is mediated by reduced     inflammation with improvement of symptom control.   "
77490|NCT02271568|"     The purpose of this study is to determine the change in kidney function and blood pressure     after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly     focus on glomerular filtration rate(GFR) with known relation to the renal function and 24     hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical     treatment.   "
77491|NCT02271555|"     The investigators will be evaluated the effects of a single loading dose of remifentanil     (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile,     seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with     major depression   "
77492|NCT02271542|"     Identification of Polymorphisms Involved in the Metabolism of Propofol   "
77493|NCT02271529|"     The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel     delivery system.   "
77494|NCT02271516|"     This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of     188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.   "
77495|NCT02271503|"     This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period,     single-dose crossover study. Approximately 51 qualified immediate-release (IR)     CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing     sequences.      Objectives:        -  Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa)          in subjects with advanced Parkinson's disease.        -  Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.   "
77496|NCT02271490|"     Introduction To get through the egg vestment and fertilize the oocyte, the spermatozoon uses     its acrosomal enzymes. When Intracytoplasmic sperm microinjection (ICSI) is performed, the     acrosomal enzymes are introduced with the spermatozoa inside the ooplasme.      The fate of these enzymes, that normally never enter the oocyte, is not known. But they     impair the embryo development.      Indeed, although the ICSI outcome is satisfactory in humans, a series of studies in many     species (mouse, hamster, cattle, and horse) demonstrate the deleterious effects of the     introduction of acrosomal material in the oocyte cytoplasm, on embryo and fetal development.     These studies have also shown two things:        -  The bigger the acrosome, the more deleterious are the effects of their introduction into          the egg.        -  And that the induction of the acrosome reaction (AR) prior to ICSI significantly          improves embryonic development and the number of babies born after embryo transfer as it          is the case in the mouse. The microinjection of acrosome reacted sperm increases from 40          to 70 % the percentage of pups born per embryo transferred.      Hypothesis :      It is possible to improve ICSI outcome, in terms of babies born in human, by induction of the     AR prior to microinjection.      After studying several techniques, we choose a physiologic technique for acrosome induction.      The induction of acrosome reaction prior to ICSI should improve in utero fetal development     and decrease the rate of miscarriage and pregnancy arrest.   "
78886|NCT02253290|"     This project is a retrospective and prospective investigation of neuropsychological and     psychosocial development of children with a neuromuscular disease.   "
77498|NCT02271464|"     This study consist of 4-months induction first-line chemotherapy with the G.O.N.O. FOLFOXIRI     regimen plus bevacizumab followed by maintenance with bevacizumab or bevacizumab plus     metronomic chemotherapy (with capecitabine and cyclophosphamide) in mCRC patients.      The main objective of this study is to preliminarily evaluate the potential effects of the     combination of a metronomic chemotherapy with capecitabine and cyclophosphamide to     maintenance bevacizumab on pharmacodynamic and clinical parameters among mCRC patients.   "
77499|NCT02271451|"     Significant morbidity, mortality, and related costs are caused by traumatic brain injury     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save     lives, and the huge costs currently being experienced for life-treatment of surviving     victims. An externally-worn medical device that applies mild jugular compression according to     the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC     (Q30). Initial research suggests that the Device has the potential to reduce the likelihood     of TBI. The currently developed collar (Smith 2009; Smith 2011; Smith 2011; Smith 2012) has     been approved for studies in humans and the results indicate safety for use during high     demand and maximal exertion activities, Study ID: 2013-2240, Institutional Review Board -     Federalwide Assurance #00002988). Regarding safety, the externally worn collar is     meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins     that will provide similar pressure and volume increases not to surpass that of a yawn or the     mere act of just lying down.      This study will investigate the effectiveness of this device in high school athletes playing     a collision or contact sport such as football, hockey, or lacrosse. The high risk sports     which utilize helmets during competition will allow for measurements systems to be embedded     in the headgear and will not affect play or fit of equipment. Athletes participating in this     study will be enrolled into one of two groups 1) device wearing or 2) non-device wearing. By     the nature of the sports selected, it is likely this pilot study will primarily include     males, however if any female meets inclusion criteria on the team selected they will be     included in this pilot investigation. The helmets of all participants will be outfitted with     an accelerometer which will measure the magnitude of every impact to the head sustained by     the athlete. Effectiveness of the device will be determined by brain imaging during the     pre-season, midseason, and end of season time points. A subset of athletes who report a     diagnosed concussion will also receive additional brain imaging within the week following the     diagnosed concussive event.   "
77500|NCT02271438|"     The purpose of this study is to assess the safety and tolerability of ibrutinib, to compare     the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and     to assess the effects of a single dose of ibrutinib on QT/QTc intervals and electrocardiogram     (ECG) in healthy adults.   "
77504|NCT02271386|"     Although numerous studies have demonstrated that a high percentage of primary care providers     (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing     ADHD, many fail to implement these guidelines correctly. The goal of this project is to     increase the use of evidence-based practices (EBP) for assessing and treating children with     ADHD between 5 and 12 years in the context of primary care practice. This randomized     controlled trial will evaluate the whether a 3-part intervention (education about ADHD     management and communication training, collaborative consultation, and performance feedback     regarding use of EBPs) is effective in improving EBP use among primary care providers.   "
77505|NCT02271373|"     The purpose of this study is to develop a school-based intervention aimed at prevent the     onset and development of myopia among school aged children by increasing time spent outdoors     in northeast China.   "
77506|NCT02271360|"     The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral     Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women     underwent intracytoplasmic sperm injection (ICSI).   "
77507|NCT02271347|"     The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV)     when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total     of 5 doses.   "
77508|NCT02271334|"     The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of     A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220     mcg (T2), in healthy male and female adult volunteers.   "
77509|NCT02271321|"     The purpose of this study will be to examine the effects of white noise on agitation and     saliva cortisol in elderly with dementia.   "
77510|NCT02271308|"     This study will examine the effects of low-resistance elastic band training on muscle     strength, flexibility, quality of life and ease of care among the residents in nursing homes.   "
77511|NCT02271295|"     Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved     in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in     cirrhotic patients   "
77512|NCT02271282|"     Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to     estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that     estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and     insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic     syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in     prostatic cancer   "
77513|NCT02271269|"     Glaucoma topical eye medications, when adhered to, are effective at controlling disease     progression. Yet evidence shows that many glaucoma patients have incomplete adherence to     medications, with disease progression resulting in significant costs to the patient and     health system. Through the approach of value pricing, a link can be made between     non-adherence and its resulting costs by granting subsidies to adherent patients for their     medications and physician visits. This 6-month randomized controlled trial among 100 glaucoma     patients from the Singapore National Eye Centre aims to test the extent to which value     pricing can improve medication adherence.   "
77523|NCT02271139|"     This is an open-label, multicenter, single-arm, expanded access study designed to provide     alectinib to participants with ALK-rearranged NSCLC after disease progression on or     intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive     alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or     physician decision to discontinue treatment, death, alectinib becomes commercially available     in the United States following approval of alectinib by the FDA, or the Sponsor decides to     close the trial, whichever occurs first (approximately 15 months).   "
77592|NCT02270229|"     The purpose of this study is to develop recommendations to assist in improving the current     peritoneal dialysis (PD) program in a Hospital in Chinandega, Nicaragua. This project will     consist of a needs assessment, a review of aggregate quantitative patient data from hospital     records, and a knowledge, attitudes, and practices (KAP) assessment for medical providers,     laboratory technicians, patients and primary caregivers. The final report will be used to     obtain funding for the implementation of the recommendations.   "
77514|NCT02271256|"     Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads     to the three dimensional deformity of the spine. Spine curvature increases in youths as     puberty progresses. Generally, only observation is suggested for adolescents with early     scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the     high corrective force which nearly constrains all movements. Flexible brace treatment is an     alternative option; however, its efficacy is still controversial. Functional intimate apparel     with a specialized design for teenagers with scoliosis is limited and most part of them can     only provide some improvement for bad postures, such as hunchback. A scientific approach     should be used to design and develop functional intimate apparel as a treatment option for     adolescents with early scoliosis.      This project aims to combine clinical experience with textiles and materials sciences to     research and develop functional intimate apparel for adolescents with early scoliosis. As a     result, this will reduce the future likelihood of brace wear or surgery.      In this study, the eligible subjects will be given tailor-made functional intimate apparel to     wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months     wearing period. The effectiveness of the functional intimate apparel will be evaluated by     pre- and post- treatment X-ray radiography.   "
77515|NCT02271243|"     Central line-associated bloodstream infections (CLABSIs) are the most common     healthcare-associated infection in children and are associated with morbidity and mortality.     This study will attempt to identify the source of bloodstream infections (BSIs) in children     with CLABSI because we hypothesize that many of the BSIs that are currently classified as     CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result     of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will     isolate bacteria from multiple body sites of children that have BSI in order to compare these     bacteria to the strain growing in their blood using whole-genome DNA sequencing. We will also     evaluate biomarkers of MBI of the respiratory tract and GI tract.   "
77516|NCT02271230|"     This study will examine whether an intervention with vitamin D or fish oil supplements can     reduce the risk of heart failure among adult men and women during a follow up period of up to     five years (starting from the time of randomization into the parent VITAL trial). The     investigators hypotheses are that both vitamin D and fish oil supplements will each reduce     the risk of heart failure.   "
77517|NCT02271217|"     The objective of this study is to determine the effect of two dose strengths of     dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable     walking deficits in subjects with post-ischemic stroke.   "
77518|NCT02271204|"     This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent     administration in patients with postmenopausal osteoporosis and the efficacy of IV     Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral     densitometry form baseline at year 1)   "
77519|NCT02271191|"     The aim of this study was to demonstrate the effect of nicardipine on renal function with     creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium     during deliberate hypotension for spine surgery.   "
77520|NCT02271178|"     Patients who survive an acute coronary syndrome are at high risk of recurrent events and     death in the first months of evolution. Aspirin, angiotensin-converting enzyme, beta-blockers     and statins decrease the risk of recurrent events and death, so are the recommended treatment     for most patients who had a heart attack, and adherence to these recommendations is     associated better clinical outcome. However, numerous studies show high dropout rate of     medical treatment. The cause of nonadherence, common problem in chronic diseases, is     multifactorial (economic, cultural, adverse effects), the complexity of the treatment being     prescribed a relevant factor as a cause of non-compliance. The investigators goal is to     assess whether the simplification of treatment for secondary prevention in a once-daily     capsule containing four drugs increased adherence to it, compared to the standard treatment     of each drug separately.      The investigators design a controlled, randomized, open, parallel-group clinical study.     Patients will be randomized to one of the following treatment regimens:        -  Combined-Capsule: capsule containing an adjusted patient combination scheme for          secondary prevention of once daily.        -  Usual-treatment: each component of the dish separately as is the usual practice.      The primary endpoint is the adherence of the treatment regimen to secondary prevention. For     the study was considered adherent to a patient taking at least 80% of medication that belongs     in the period.   "
77521|NCT02271165|"     The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin     SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis.     Hizentra provides effective protection against infection by maintaining a steady and normal     level of immunoglobulin in the body) in patients with primary immunodeficiency. At present,     patients with steroid resistant dermatomyositis can only be treated with IVIg (The healthy     antibodies in IVIG can block the damaging antibodies that attack muscle and skin in     dermatomyositis) treatment. An evaluation can then be made to see if SCIg is a suitable     replacement and exerts immunomodulatory effect on complement antibodies.   "
77522|NCT02271152|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide with a prevalence of     8% in the elderly. AF is responsible for frequent hospitalizations, stroke, heart failure and     mortality. AF catheter ablation is an important treatment strategy for patients suffering     from AF, but the success rate remains low after conventional pulmonary vein isolation (PVI).     The mechanism perpetuating AF is poorly understood. Focal electrical sources and triggers     (FAST) may sustain AF in some patients, which makes them a potential therapeutic target for     ablation. However, finding FAST is very challenging due to complex nature of AF electrical     signals. In this study, the investigators will attempt to localize focal electrical sources     and triggers (FAST mapping) in patients undergoing AF ablation using custom software that     evaluates periodicity and waveform morphology. Patients will be randomized to one of two AF     ablation strategies, namely FAST mapping/ablation + PVI vs. PVI alone. The investigators will     determine which strategy leads to better clinical outcome postablation.   "
77593|NCT02270216|"     Aim to study the exercise responses to both static and dynamic exercise in elderly people     with and without essential isolated systolic hypertension, seeking to identify potentially     dangerously high responses   "
77524|NCT02271126|"     The best anticoagulation strategy during Extracorporeal Membrane Oxygenation (ECMO) is     unknown. Actual recommendations suggest to use unfractionated heparin infusion and monitor     the effect with either activated Partial Thromboplastin Time (aPTT) or Activated Clotting     Time (ACT). Since hemorrhage is still the major adverse effect of ECMO with impact on     mortality and morbidity, the investigators raised a question whether an alternative     monitoring technique namely Thromboelastography (TEG) could allow a more accurate management     of anticoagulation in this setting. To test this hypothesis the investigators designed a     pilot study to test safety and feasibility of an anticoagulation monitoring algorithm based     on TEG versus aPTT.   "
77525|NCT02271113|"     In this study, the investigators will evaluate the safety, pharmacokinetics and effect on     target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of     GMI-1271, an E-selectin antagonist, in healthy volunteers.   "
77526|NCT02271100|"     This study is intended to determine whether ultrasound imaging can improve the ability to     place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of     ultrasound for the placement of epidural catheters the investigators hope to answer two     questions:      1. How does the traditional technique based on palpation compare to one using ultrasound to     place an epidural catheter? 2. Does ultrasound reduce one potential risk in epidural     placement?   "
77527|NCT02271074|"     The main objective of this study is to compare the effectiveness of combinations of three     patient-oriented strategies, compared to the standard of care, to increase the proportion of     patients who enter-into-care for HIV within 90 days of testing HIV positive.   "
77528|NCT02271061|"     The purpose of this study to investigate joint angle and joint moment in flexion-extension,     adduction-abduction and internal -external rotation of elastic therapeutic tape and elastic     therapeutic tape are effective in ACL-injuries subjects during drop vertical jump.This study     requires ACL-injuries participants age range between 18 and 45 years old. The 3D motion     analysis system (BTS, ITALY) and force plate (Kistler, USA) will be used for measure joint     angle and joint moment during drop vertical jump movement.   "
77538|NCT02270931|"     The purpose of this study is to obtain sufficient specimens and correlating clinical data     from a well-controlled prospective clinical trial collecting longitudinal specimens from     subjects diagnosed with any stage of breast cancer.   "
77539|NCT02270918|"     Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug     Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with     non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA     approved drug derived from blood that is used as an antidote to treat people with bleeding     associated with taking the well-known anticoagulant warfarin. This is a Phase I,     placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility     apixaban anticoagulation with Kcentra.   "
77529|NCT02271048|"     Purpose      - The investigators aim to evaluate the feasibility of remote interpretation for ultrasound     images using a smartphone based realtime image transmission system.      Methods      A total of 100 echocardiography examinations; 50 showed the ejection fraction above 50% and     remaining 50 cases showed the ejection fraction under 50%, and 100 abdominal ultrasound     images; 50 had signs of acute appendicitis and the other 50 had no findings of appendicitis     will be consecutively selected. The 12 raters review these original images using an LCD     monitor of the ultrasound machine and also an iPhone which is connected to the ultrasound     machine via remote image transmission system (CubeView, Alpinion medical system, Seoul,     Korea), evaluating left ventricular systolic function (for echocardiography) by measuring the     ejection fraction and grading the probability of presence of acute appendicitis on each     examination by a five Likert scale.      The sensitivity and specificity between two devices will be compared and the diagnostic     performance between two devices will be also compared. The image quality between two devices     will be measured using the double stimulation impairment scale (DSIS)   "
77530|NCT02271035|"     Vesicoureteral reflux (VUR) is the most common urologic diagnosis in neonates estimated at 1%     of newborns, and 30-45% of the children who present with urinary tract infection (1).      Optional treatments of children with VUR include conservative therapy with or without     prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery.      In an endoscopic technique, the injecting needle is inserted through the working channel of     the cystoscope. The procedure is relatively short and is performed as out-patient surgery.      In 2000, Dextranomer/Hyaluronic acid (DefluxR) was approved by the FDA, and subsequently has     become the treatment of choice in VUR grades 2-4.      In 2004, the hydrodistention-implantation technique (HIT) was introduced by Kirsch. HIT     involves the use of a pressurized stream of fluid directed into the ureter to aid     visualization, and injection into the submucosa within the ureteric tunnel to improve     coaptation of the ureter (3).      One of the disadvantages attributed to Deflux is the loss of 20% of the injected material     over time (a result of absorption of the hyaluronic acid), which may explain the lower     success rate of the endoscopic treatment of VUR compared with open surgery.      In 2005, Polyacrylate Polyalcohol (VantrisR), a non- absorbable chemical preparation was     introduced for endoscopic treatment of VUR, aiming to improve on the results of Deflux by     preventing volume loss. Preliminary results of a three year follow-up using Vantris have     shown high a level of reflux resolution(4).      The aim of the current study is to compare the rate of resolution of the VUR using Deflux     versus Vantris in bilateral VUR   "
77547|NCT02270814|"     The purpose of this research study is to look at the effect of a treatment regimen called     CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called     cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of     cisplatin if participants have previously had problems receiving cisplatin). The use of     nab-paclitaxel in this combination is different from routine care, in which a drug called 5FU     is often given instead, but the investigators group has conducted previous research where the     investigators incorporated nab-paclitaxel into routine treatment with cisplatin, 5FU, and     cetuximab. The investigators are looking at the incidence of side effects with the CACTUX     regimen as well as response of the disease and health status.   "
77548|NCT02270801|"     This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at     evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.   "
77531|NCT02271022|"     The primary objective of the UPSTREAM Registry is to address the data gap regarding the     course of NSTEMI (Non-ST-Elevation Myocardial Infarction)between ED (Emergency Department)     arrival and diagnostic angiography in detail, by characterizing and following the ED and     peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED     treatment patterns and success of both ischemic and bleeding risk stratification prior to     definition of the coronary anatomy, data generated via the UPSTREAM registry will allow     plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet     therapy in the management of NSTEMI. This registry further seeks to demonstrate that     contemporary use of upstream ticagrelor is associated with an economically-sound utilization     of hospital resources, and smooth transition of care into the outpatient, secondary     prevention setting for the first 30 days after hospitalization. Finally, it will allow     characterization of patient selection factors and processes for ticagrelor vs alternative OAP     agents, carrying out that descriptive comparison through discharge. Patients transferred in     to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent     administration and diagnostic catheterization begin with ED care at the first hospital.   "
77532|NCT02271009|"     The purpose of this study is to find the optimal dose of AllerT that should be used to treat     moderate to severe allergies due to birch tree pollen.      There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at     different doses and 1 treatment group will receive placebo.      This study will also assess the effectiveness and safety of AllerT compared to placebo in     relieving allergy symptoms.   "
77533|NCT02270996|"     Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis     patients do not require antibiotics after appendectomy. Although guidelines and     recommendations exist to decrease post-operative antibiotic mis-use after appendectomy,     surgeons continue to prescribe unwarranted antibiotics.      The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric     Surgery will decrease the use of un-warranted antibiotics.   "
77534|NCT02270983|"     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the     treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment     for chronic non-cancer pain that has been present for a minimum of 3 months.      This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.     Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or     placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel     movement frequency, as well as other bowel symptoms of OIC.   "
77535|NCT02270970|"     This will be an open label, non-randomized trial of belimumab in at least 20 subjects to test     the feasibility of belimumab as a single agent and to capitalize on simplified background     treatment regimens to determine immunologic differences between patients who do versus do not     meet clinical response criteria.   "
77536|NCT02270957|"     This is a randomized, double blind, placebo controlled trial of abatacept for the treatment     of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3     tender and 3 swollen joints and </= 20 mg prednisone have other background immune     suppressants withdrawn at entry. They can elect to receive up to a total of 320 mg depomedrol     (in two or more injections) between the screening visit and the visit 2 months after dosing     begins. Abatacept (125 mg) or placebo is administered in weekly subcutaneous doses. After 3     months of treatment patients who are not responding may elect to receive open label abatacept     with or without additional standard of care therapies. Such patients are considered non     responders. The primary endpoint is the British Isles Lupus Assessment Group Index     (BILAG)-linked Combined Lupus Assessment (BICLA) which will require a clinically significant     improvement in arthritis and other active features of lupus   "
77540|NCT02270905|"     The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial     replacement of the native medial or lateral meniscus with the investigational product.   "
77542|NCT02270879|"     Prediction errors for the first (PE1) and second eyes (PE2) were obtained in the intra-ocular     lens power calculation for 4 formulae (HofferQ, SRK II, SRK/T and Holladay 1). The optimal     correction factor for each formula was determined as the one resulting in the lowest mean     absolute error. A similar analysis was performed in the negative and positive PE1 subgroups.   "
77543|NCT02270866|"     This is a pilot study with a single active treatment arm. The study is designed to assess the     efficacy of a portable, non-invasive neuromodulation system for the treatment of post-stroke     aphasia. Both language and movement assessments will be made.   "
77544|NCT02270853|"     In this study it will be analyzed how often the sleep apnea syndrome can be observed in     patients with newly diagnosed lung cancer with the help of ApneaLink device by ResMed.   "
77545|NCT02270840|"     Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes     in patient in left ventricular dysfunction and intermittent or permanent apical/septal right     ventricular pacing (Budapest CRT upgrade study)   "
77546|NCT02270827|"     This study focuses on severe asthmatics and their asthma symptoms. 40% of asthma patients     continue to experience symptoms and up to 5% of these have difficult-to-control asthma     despite continually improving treatments. Severe asthmatics experience clinically-significant     worse health-related quality of life than those than those with less severe asthma. Poorer     health-related quality of life can be as a consequence of frequent, severe symptoms, which     prevent the patient from continuing a normal, active lifestyle. The Royal Brompton Hospital     uses the treatment regimen of intravenous (IV) Aminophylline and IV Hydrocortisone which     appears to improve symptoms and reduce exacerbations. At present there is anecdotal evidence     to support these assumptions. The objective of this study is to determine whether there is     any objective evidence of improvement, in particular looking at lung function, symptoms and     cardiovascular function.   "
77569|NCT02270528|"     This study will examine the acute effects of high intensity interval ergometry on peripheral     concentrations of lactate and hydrogen ions, as well as cognitive function. Approximately 60     healthy, college-aged males will participate in the Wisconsin Card Sorting Task (WCST), a     measure of executive function, two times over a span of two weeks. Prior to the WCST,     participants will complete either a warm-up, a warm-up and high intensity interval exercise,     or a stationary period. Changes in lactate, pH, and WCST score will be evaluated between and     within groups in relation to the presence of the high intensity exercise stimulus.   "
77549|NCT02270788|"     PRIMARY OBJECTIVE:      This is a pilot study to characterize the toxicity profile, to determine the maximum     tolerated dose of the combination of crenolanib and sorafenib, and to determine the     feasibility of administering these drugs in patients with relapsed or refractory hematologic     malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic syndrome     (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with FLT3-internal     tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations.      The study will include two phases:        -  The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and          determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of          crenolanib when given in combination with sorafenib.        -  The dose-expansion cohort will further assess the safety and explore the efficacy of          this combination.   "
77550|NCT02270775|"     The study will include a translation of the Central Sensisization Inventory into French and a     cultural validation of the French version of the questionnaire (Reliability, discrimination     and comparison with other questionnaires).   "
77551|NCT02270762|"     In the critically patient bed rest and inmovilization are some of the responsable of the     development of respiratory complications. Early physical exercise is a tool to prevent     respiratory complications as lost of respiratory muscle strength, decrease in functional     residual capacity and hypoxemia improving oxygenation. In some cases critically ill     conditions implies use of pharmacological sedation. That condition limit the active physical     exercise. However, some technicals aids as Tilt table allows execution of passive early     movilization.      The aim of this study is to assess the effect of early passive verticalization assisted by     tilt table on alveolar recruitment and pulmonary ventilation in intensive care unit (ICU)     patients, evaluated with electrical impedance tomography (EIT) ICU patients included at day     of evaluation will be evaluated consecutively with EIT in three stages; 1) in the supine     position (at 30° of inclination), 2) verticalized in tilt table (at 60º of inclination) 3) in     the supine position (at 30° of inclination)   "
77552|NCT02270749|"     The purpose of this study is to evaluate the most effective treatment for patients who     underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.   "
77553|NCT02270736|"     The objective of this study is to investigate the efficacy and safety of NT 201 compared with     placebo for the treatment of chronic troublesome sialorrhea associated with neurological     disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in     children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.   "
77554|NCT02270723|"     In a randomized clinical trial, the purpose is to investigate if perioperative coagulation     and hemorrhage is influenced by colloid or crystalloid.   "
77563|NCT02270606|"     This phase I trial studies the side effects and best dose of fluorouracil when given together     with radiation therapy followed by combination chemotherapy before and after surgery in     treating patients with rectal cancer that has spread from where it started to nearby tissue     or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells and shrink     tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving more than     one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving additional combination chemotherapy     after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil     followed by combination chemotherapy before and after surgery may be a better treatment for     rectal cancer.   "
77555|NCT02270710|"     It is well known that the deregulation of immune responses plays a major role in many     autoimmune diseases, such as Systemic Lupus Erythematosus (SLE). The main objective of this     protocol is to determine whether the expression and/or function of specific molecules are     deregulated in the immune cells of patients with SLE. By examining IRF4, IRF5, IBP/Def6,     SWAP-70, Rock1, Rock2, and specific signaling molecules involved in the responsiveness to sex     hormones, the investigators hypothesize that the deregulation in the expression and function     of these molecules will result in abnormalities in the functioning of the immune cells, which     is a key factor in autoimmunity.      Peripheral blood lymphocytes from healthy controls and patients with SLE will be collected     and compared in order to determine if specific immune cells (IL-17 and IL-21) are deregulated     in patients with SLE and if this deregulation affects their functioning. Specifically, immune     cells will be isolated from the blood and then subject to scientific testing (QPCR, Western     blotting, immunofluorescence assays, ELISA and FACS analysis) to see if the expression and     function of these cells is related to the mechanism behind SLE. This will be a case control     study, where cases of SLE will be compared to controls of healthy volunteers to assess risk     factors. As these healthy volunteers are providing samples solely for research purposes,     there is no standard of care for these volunteers, with the exception of a positive HIV     result during screening. The Department of Genetic Medicine will enroll healthy controls and     the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE)     for a comparative analysis of the two cohorts. Laboratory testing on all blood samples will     be done at the Hospital for Special Surgery.   "
77556|NCT02270697|"     The nail specimens from patients with suspect onychomycosis were analyzed. Samples were     collected as part of standard patient care from the Department of Dermatology, National Cheng     Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Comparing the     array results with the regular methods by sensitivity, specificity, NPV and PPV.   "
77557|NCT02270684|"     The purpose of this study is to compare the short-term changes in gait parameters and     functional outcomes after total knee arthroplasty between those who use the StepRite device     and those who follow a standard therapy program without the device.   "
77570|NCT02270515|"     This study will implement and evaluate a patient-centered medical home for kidney disease     (PCMH-KD) compared to the usual model of dialysis care. Patients will be observed for an     initial baseline period under the usual care model and then the usual dialysis care team will     be expanded to include a pharmacist, community health worker, nurse coordinator and a primary     care doctor. Outcomes of interest will be assessed at baseline and then every 6 months after     the PCMH-KD intervention commences.   "
77558|NCT02270671|"     Attention bias modification training (ABMT) is a computer-based attention training programme     designed to modify the way a person's attention is directed to mild threats in the     environment. What a person focuses their attention on plays an important role in how safe or     unsafe they feel in certain situations. Much research has shown that people with high levels     of anxiety tend to focus their attention on negative information in their surroundings. The     purpose of ABMT is to set in place attention patterns that do not lead to excessive anxiety.     The present study will test whether this treatment is effective in reducing social anxiety in     15-18 year olds in school settings.      The study design consists of two phases. During Phase 1 participants will complete a     screening questionnaire in relation to their wellbeing and emotions. This questionnaire will     include a measure of the affective, cognitive, and behavioural components of social anxiety     in adolescence. Depending on their suitability (i.e. scoring above a cut-off on a     standardised measure of social anxiety in Phase 1 of the study), participants may then be     invited to take part in a 4-week computer-based attention training programme. The purpose of     this phase is to see if ABMT will help young people feel less worried or nervous in social     situations by teaching them to focus on their environment differently.      Previous research containing attention training tasks similar to this training programme     suggests that attention training can reduce symptoms of social anxiety in adolescents.     Individuals who are invited to take part in the training session will be randomly assigned to     either the intervention or placebo (inactive) group. Both groups will be asked to complete a     4-week programme involving one computer training session per week (each session takes     approximately 15-20 minutes).      Questionnaires will also be given to participants to complete before and after the     intervention, along with a 12-week follow up assessment. These will include questionnaires to     measure social anxiety, depressive symptoms, and fears in relation to negative evaluation.     Each questionnaire will take approximately 40 minutes to complete. Participants will not know     whether they have received the intervention or placebo training until after the intervention.   "
77559|NCT02270658|"     MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with     uncontrolled hypertension and at least one antihypertensive medication. Those patients with     significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.   "
77560|NCT02270645|"     Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish     to or cannot tolerate other treatment modalities such as topical chemotherapeutics or     surgery.      In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm     Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm     in size. This is an unblinded study in which patients will be randomized to either a     treatment arm or a control arm. Patients in the treatment arm will receive three treatments     with the 595/1064 nm multiplex laser spaced four weeks apart. The control group will visit     the clinic with the same schedule as the treatment group for monitoring of the lesion. All     patients will return one month after last treatment session or clinical visit, for evaluation     of clinical and histological clearance.   "
77561|NCT02270632|"     A multicenter, randomized, parallel assignment, double blind, placebo-controlled,     safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients     with active rheumatoid arthritis receiving MTX.   "
77562|NCT02270619|"     Late-life depression is a major public health burden due to its high prevalence and     associated morbidity, suicide risk, functional decline, and mortality. Unfortunately, current     antidepressant therapies have limited effectiveness; hence, biologically plausible models for     new treatments are being pursued. Systemic inflammation is hypothesized to play an important     role on the onset and perpetuation of depression, especially in older women. Aging processes     involve a heightened inflammatory state, and both inflammatory disorders and depression are     more prevalent in women than men. However, increased systemic inflammation does not     necessarily lead to depression in all women. Even when robust systemic inflammation is     experimentally induced (e.g. endotoxin administration), largely variable increases in     depressive symptoms are found. Defining the factors that account for this variability may     identify individuals at risk of developing depression when exposed to heightened inflammatory     states such as aging, obesity, and chronic disease, and informs future translational studies     of depression prevention. In particular, the role of sleep disturbance in explaining this     variability requires further attention because it is an independent risk factor for     depression and heightens systemic inflammation by increasing the production of     proinflammatory cytokines. The investigators have also discovered that women, but not men,     who report sleep disturbance including short sleep duration experience significantly more     depressive symptoms in response to an inflammatory challenge than women without sleep     disturbance. Thus, it is hypothesized that sleep loss is a vulnerability factor for     inflammation-induced depressive symptoms in women. However, to date, no experimental approach     has been used to evaluate the role of sleep loss on inflammation-induced depressive symptoms.     This proposal aims to examine this hypothesis by partial sleep deprivation (PSD) followed by     endotoxin challenge in older women. It also aims to explore genomic and socio- emotional     mechanisms underlying the association between sleep loss and depressive symptoms. In a     randomized controlled factorial design, 80 healthy female volunteers aged 60 to 80 will be     randomly assigned to one of 4 arms: 1) uninterrupted sleep followed by placebo; 2)     uninterrupted sleep followed by endotoxin; 3) PSD followed by placebo; or 4) PSD followed by     endotoxin. Subjects will be administered placebo or endotoxin in the morning after PSD or     uninterrupted sleep. Depressive symptoms will be repeatedly assessed over 6 hours after     placebo or endotoxin administration.   "
77564|NCT02270593|"     Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the     oxidant / antioxidant enzyme levels.   "
80573|NCT02231268|"     -  Evaluation of a 6-months treatment with Gladem        -  Experiences with the internet for performing a postmarketing study (PMS) trial   "
77565|NCT02270580|"     A randomized controlled trial (RCT) with 2 patient navigator conditions: PN+ and usual PN in     which (condition 1) we will evaluate the efficacy of a culturally tailored PN program (PN+)     on improving quality of life (QoL), screening practices and treatment follow-up compliance     among breast HL survivors. In usual PN, participants will receive information brochures on     breast cancer survivorship and have a minimum of 1 contact with the patient navigator.   "
77566|NCT02270567|"     Neuroendocrine tumors are derived from the neuroendocrine system of the     gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include surgery,     medical and ablative therapies as well as peptide-receptor radionuclide therapy. Survival is     linked to early and accurate diagnoses or to the effective detection of disease recurrence     and/or treatment failure. One challenge is to develop accurate non-invasive blood tests that     can detect neuroendocrine tumor activity. A second challenge is to evaluate the effectiveness     of molecular biomarkers in the natural history of this disease. RegisterNET registry aims at     collecting data and blood samples from patients presenting with a NET in the USA. Data will     be entered prospectively and anonymized after informed consent. All physicians who treat     neuroendocrine tumor patients are invited to participate to the registry. Data will be     evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the     different types and grades of tumors, treatment modalities and patient outcomes (e.g. disease     recurrence and survival), thereby contributing to an understanding of the role of biomarkers     in tumor management.   "
77567|NCT02270554|"     The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple     Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal     pancreatectomy by a prospective, multi-center trial.   "
77568|NCT02270541|"     Interventional prospective randomized open blinded end-point (PROBE) single-center clinical     trial on the evaluation of the efficacy, safety, feasibility, reliability, and     cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.   "
77634|NCT02269683|"     The present randomized controlled trial evaluates the incidence of R1 resections in patients     undergoing robotic distal pancreatectomy compared to the laparoscopic technique.   "
77571|NCT02270502|"     The primary aim of the study is to evaluate consequences of frailty in critically ill     patients. We hypothesize that a higher frailty index (based on published questionnaires)     predicts a longer surgical intensive care unit and hospital length of stay, less     ventilator-free days and a higher likelihood of an adverse discharge disposition.      Our secondary aim is to identify muscle-size derived variables that can be used to predict     frailty. We hypothesize that a low skeletal muscle mass measured by ultrasound can be used to     quantify frailty, and to also predict the outcome of SICU patients, expressed as longer stay     in the surgical intensive care unit and longer stay in the hospital, less ventilator-free     days and a higher likelihood of an adverse discharge disposition.      Our third aim is to examine potential triggers of muscle wasting in critically ill patients.     Muscle wasting will be assessed by repetitive ultrasound measurements of muscle mass. We     hypothesize that a significant decrease in skeletal muscle mass predicts longer stay at the     surgical intensive care unit and longer hospital length of stay, less ventilator-free days     and adverse discharge disposition.   "
77572|NCT02270489|"     This is a randomized controlled parallel Group phase I study to investigate the safety and     immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A,     given to patients with early Multiple System Atrophy (MSA).      In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment     arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A     (with adjuvant) and 6 patients in the control group who will receive the reference substance     (Placebo). Over a study duration of 52 weeks, the study participants will receive 4     injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks     after the first injection. Male and female patients aged 30 to 75 years can participate in     the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.      AFF009 is part of the project SYMPATH funded by the European Commission     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).   "
77573|NCT02270476|"     The purpose of this study is to further characterize early CF lung disease in newborns,     infants and toddlers with cystic fibrosis (CF).   "
77574|NCT02270463|"     This is a non-randomized open label multi-center study. Patients who are in their first     complete remission (CR) following induction therapy will be treated with SL-401, which will     be administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or     more cycles. Stage 1 will consist of a period in which approximately 6-9 patients will be     treated with SL-401 at 3 dose levels. During Stage 2, approximately 24-29 patients with     minimal residual disease (MRD) in their bone marrow will be treated at a maximum tolerated     dose or maximum tested dose in which multiple dose-limiting toxicities are not observed     (identified in Stage 1).   "
77575|NCT02270450|"     This partially randomized clinical trial studies surgery or non-surgical management in     treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a     common problem for advanced cancer patients and can negatively affect quality of life. It is     not yet known whether surgery or non-surgical management is the best treatment option for     bowel obstruction and can lead to better quality of life.   "
77576|NCT02270437|"     We investigated the safety and efficacy of the bilateral periarticular cocktail injection at     a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.   "
77577|NCT02270424|"     The aim of this study is to compare the effectiveness of two treatments for severe / very     severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic     Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments     and conventional medicine, which have been evaluated and have certain effect.   "
77578|NCT02270411|"     The objective of this non-therapeutic experiment is to develop a method to isolate     inflammatory cells from skin biopsies as well as a method to evaluate the expression of genes     in those cells that are involved in inflammation. It could eventually be used to better     understand the following conditions: atopic dermatitis, acne rosacea and acne vulgaris. It     can also be used to better understand how various medications work in patients with atopic     dermatitis, acne rosacea and acne vulgaris.      Up to 15 healthy volunteers, 15 subjects with atopic dermatitis, 15 subjects with acne     rosacea and up to 15 subjects with acne vulgaris will be selected. For healthy volunteers and     subjects with atopic dermatitis, a maximum of four (4) skin biopsies (2-4 mm) per subject     will be taken.      For subjects with acne rosacea and acne vulgaris, a maximum of two (2) skin biopsies (3 mm)     per subject will be collected. Biopsies will be performed on either the trunk or the limbs,     excluding the hands and the feet. The biopsies will be used to develop a method to isolate     inflammatory cells from the skin. Various protocols will be tested to find the best method.     No medication will be given to you for this experiment.   "
77579|NCT02270398|"     Background Functional community ambulation not only requires a critical level of postural     control and walking skills, but also the ability to engage in cognitive tasks while walking     (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There     is evidence showed that dual-task balance and gait performance is significantly impaired     after stroke. Increasing evidence also suggests that dual-task balance and gait performance     is useful for predicting falls among individuals with stroke. Considering the high clinical     relevance of dual-task balance and gait performance, it is essential that stroke     rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance     and gait training to enhance dual-task performance is thus necessary to promote community     ambulation and reintegration.      Study Aim The aim of this Introduction Many individuals after stroke continue to cope with     residual physical impairments after discharge from hospital. One of the major problems     encountered by people after stroke is community reintegration. Functional community     ambulation not only requires a critical level of postural control and walking skills, but     also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and     adapt to the constantly-changing environmental contexts. There has been an increasing     awareness of the importance of dual-task gait performance in community-dwelling individuals     with stroke in the past few years.      There is evidence showed that dual-task balance and gait performance is significantly     impaired after stroke. Increasing evidence also suggests that dual-task balance and gait     performance is useful for predicting falls among individuals with stroke. Considering the     high clinical relevance of dual-task balance and gait performance, it is essential that     stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task     balance and gait training to enhance dual-task performance is thus necessary to promote     community ambulation and reintegration.      Study Aim This will be a single-blinded randomized controlled trial (RCT).The aim of this     study is to examine the efficacy of a dual-task exercise program on cognitive-motor     interference in balance and walking tasks, balance self-efficacy, participation in everyday     activities, community reintegration and incidence of falls among individuals with chronic     stroke.   "
77580|NCT02270385|"     This study aims to evaluate the effectiveness of a PU prevention programme for for-profit     private nursing homes   "
77581|NCT02270372|"     This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with     varlilumab. Two different doses of varlilumab will be studied in combination with the single     agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may     also be studied at the recommendation of the safety monitoring committee (SMC).   "
78887|NCT02253277|"     In this study it is the rationale to evaluate the safety and tolerability of the combined     administration of nilotinib and increasing dose of ruxolitinib in patients with chronic     myeloid leukemia and patients with Philadelphia positive acute lymphoblastic leukemia.   "
77582|NCT02270359|"     The purpose of this study is to determine the prevalence of plaque disruption and to assess     the composition of disrupted plaques in patients with myocardial infarction (MI) and     non-obstructive coronary artery disease (CAD) using optical coherence tomography (OCT).     Additionally, cardiac magnetic resonance imaging (CMR) will be used to detect myocardial     abnormalities, which will be correlated to OCT findings to gain insight into the mechanisms     of MI in patients with non-obstructive coronary artery disease (i.e. open arteries).   "
77583|NCT02270346|"     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects     in many body tissues, organs and systems such as immune, cardiovascular, pulmonary,     gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and     skin.Available limited numbers of studies showed that inspiratory muscle weakness in     allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies     demonstrated beneficial effects of inspiratory muscle training on several outcomes in     different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart     failure, no published paper reported the effects of IMT in allo-HSC recipients.   "
77584|NCT02270333|"     Respiratory muscle weakness results with decreased exercise capacity, worse fatigue, dyspnea     and quality of life in patients with sarcoidosis. However, no study investigated the effects     of inspiratory muscle training (IMT), therefore effects of IMT on outcomes in patients with     sarcoidosis were investigated.   "
77585|NCT02270320|"     Background: Promotion of cognitive functions of middle aged and older adults and prevention     of dementia are important issues in the aging society. In recent years, studies have shown     that Tai Chi Chuan (TCC) exercise can improve cognitive functions in healthy middle-aged and     older adults, but not studies have investigated the neural mechanisms. Therefore, the     purposes of this research project are: (1) to investigate the effects of TCC exercise     intervention on improving cognitive functions and motor functions in healthy middle-aged and     older adults; (2) to investigate the effects of TCC intervention on improving the integrity     of frontostriatal fiber tracts, and areas and intensity of brain activation while performing     a switching task in healthy middle-aged and older adults.      Methods: This project used the assessor-blind and randomized control clinical trial design. A     total of 60 healthy middle-aged and older adults will be recruited, randomly allocated to two     groups: experimental and control groups. Experimental group will receive a 60-minute exercise     program, three times per week for 12 weeks. Control group will receive a telephone     consultation once every two weeks for 12 weeks. All participants will receive clinical     neuropsychological tests, Cambridge Neuropsychological Test Automated Battery tests, motor     function tests, diffusion spectrum MR imaging, and functional MRI experiments before     intervention, and at the end of intervention to realize the changes of cognitive function,     motor function, integrity of neural tracts, and intensity and regions of functional     activation while doing switching task of executive function in order to understand the     cognitive effects and the neural mechanisms of TCC.   "
77586|NCT02270307|"     Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive     therapy with use of MSCs and CY in patients at high risk of relapse.   "
77587|NCT02270294|"     The investigators hypothesize that Acute Thai traditional massage will yield beneficial     effects on cerebrovascular reactivity in ischemic stroke patients.   "
79491|NCT02245412|"     The objectives of this trial are to evaluate the safety, tolerability,     pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in     subjects with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI)     tract.   "
77588|NCT02270281|"     Although EGDT goals appeared to have been achieved, severe derangements of organ perfusion     were detected by SDF technique.An abnormal microvascular flow index was present in 17% of     patients in ICU . Microcirculatory alterations are stronger predictors of outcome than global     hemodynamic variables.Improvement of microcirculatory dysfunction is a big challenge to     clinician. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of     adult critically ill patients which exhibits sedative and analgesic effects. Recent studies     suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic     shock, and prevents alterations of pain rat model intestinal microcirculation Induced by     surgical stress，even it can reduce the mortality of endotoxemic rats and patients with severe     sepsis. The investigators will conduct a clinical trial to investigate the effect of     dexmedetomidine on microcirculatory dysfunction in early septic shock patients with relative     stable hemodynamics.      thirty patients with septic shock will be enrolled . After sufficient fluid resuscitation and     hemodynamic stabilization for 24 hours, these patients who required sedation will receive     continuous infusion of two dose of dexmedetomidine (infusion rate 0.3 and 0.6 mcg/kg/h) for 1     hours as needed. The sublingual microcirculation and serum level of catecholamine will be     examined at preset time points. The vital signs, hemodynamic parameters will be recorded and     analyzed.   "
77589|NCT02270268|"     The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary     fiber, on clinical symptoms, gut microbiota and the immune status in patients with     diarrhea-predominant irritable bowel syndrome   "
77590|NCT02270255|"     Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However     the procedure is often very painful and, in many centres, patients are admitted overnight     with PCA pumps for pain control and discharged the next day with heavy pain medications. The     goal of this study is to evaluate the effectiveness of a superior hypogastric nerve block in     controlling the pain post-UFE.   "
77591|NCT02270242|"     The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and     aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and     forming a blood clot that could block blood flow to the heart. This study will look to     determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus     aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events     among high-risk patients who have had a percutaneous intervention with at least one     drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or     anatomic criteria.      Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting     randomization eligibility criteria at 3 months post enrollment will be randomized to either     ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up     clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.   "
77594|NCT02270203|"     The purpose of this study is to evaluate the long term safety and effectiveness of SI joint     fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or     sacroiliac joint disruptions (SD).      Study Design: This study is extended follow-up from two ongoing multicenter prospective US     clinical trials. All participants have already undergone the surgical procedure of interest     (SI joint fusion with iFuse Implant System). The two ongoing trials are:        -  SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients          with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse          placement, and        -  INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the          same patient population who underwent either non-surgical treatment or iFuse placement   "
77595|NCT02270190|"     The main research question is to see if Percutaneous Tibial Nerve Stimulation (PTNS) can     improve the symptom of tenesmus in patients with pelvic floor disorders. This includes those     who have rectal cancer in situ or who are post-rectal cancer treatment and have Anterior     Resection Syndrome.      The secondary research questions are to see if other pelvic floor symptoms and quality of     life improves for this patient group and if levels of anxiety and depression improve for     these patients.   "
77596|NCT02270177|"     Headache is a frequent cause of visits to the GPs office, and the investigators have     previously shown that this group accounts for about 20 % of patients referred to a general     neurologic outpatient clinic.      To our knowledge, no previous study has investigated whether headache consultation through     telemedicine provides equal health care outcomes compared to regular visit to the     neurologist. If that's the case, a modern interactive health care system may give simpler and     cheaper services for patients, saving travelling costs and community expenses. It may     possibly also lead to reduced waiting lists, earlier diagnosis and treatment.      This is an open-labeled randomized non-inferiority trial of headache patients referred to a     neurologic clinic in North-Norway. The aim of this study is to determine whether video     consultations are non-inferior to regular consultations in diagnosing and treating primary     headaches. The null hypothesis is that there is no difference in patient satisfaction between     the two groups. The outcome is assessed 3 and 12 months after the neurologic consultation.      Participants will be allocated to either a telemedicine consultation or a regular     consultation at the neurologic outpatient clinic in the University Hospital of North-Norway,     Tromsø. Both groups will undergo a structured and detailed interview to clarify the diagnosis     and establish appropriate treatment. To ensure the best possible representation in the     population, our goal is to include at least 70% of all the referred patients that meet the     criteria for participation. The randomizations are made through a centralized 8-16 phone line     to the research-department in Tromsø, at the University Hospital of North-Norway.      Both primary and secondary endpoints will be assessed in questionnaires sent three and 12     months after the consultation. In addition, the quality of the physicians` referrals and     calculations of cost savings by using telemedicine will be evaluated.      The patients' informed consent will always be obtained before data collection. Patients are     able to withdraw from the study at any time. Withdrawal will not affect the treatment or     follow up. Local research ethics committee (REC) has approved the study.   "
77644|NCT02269553|"     The study is an open-label, prospective, multi-center, randomized, two treatment parallel,     comparison study of the TMJ NextGeneration(TM) and custom-fit occlusal splint in the     reduction of nocturnal bruxism episodes and monthly migraine episodes in subjects diagnosed     with sleep bruxism and headaches.   "
77597|NCT02270164|"     Pycrinil® is a purified extract of the artichoke leaf. Artichoke leaf extract (ALE) has some     clinical trial data suggesting benefit in the treatment of cholesterol disorders in several     countries, but this effect has not been studied in a U.S. population. The investigators will     give ALE or a placebo to overweight men and women with low good cholesterol to see if ALE     increases their good cholesterol. The investigators will also make sure that ALE is safe.   "
77598|NCT02270151|"     Atrial fibrillation (AF) is the most common arrhythmia and a common cause of stroke. AF can     be asymptomatic and remain undiagnosed. Both the prevalence of AF and the proportion of     strokes related to undetected AF increases with ageing. If AF is timely diagnosed and treated     accordingly with anticoagulants, disabling strokes can be prevented. In order to help     physicians in diagnosing atrial fibrillation, the MyDiagnostick was developed. It is a CE     certified device that is safe, user friendly and easy to use. This device is capable of     detecting or excluding AF within one minute by providing a registration of lead I of the ECG.      The investigators aim to perform a 2-arm cluster randomized diagnostic trial among patients     aged 65 years and over who visit the general practice. In total the investigators will     include 42 general practices of which they randomly assign 21 to the MyDiagnostick arm and 21     to the control arm. All persons aged 65 years and over who visit the general practice in the     MyDiagnostick arm will be asked to hold the device every time they visit the surgery during     one year.      The number of newly detected cases of AF with the diagnostic screening strategy with     MyDiagnostick (MyDiagnostick arm) will be compared to care as usual (control arm). Also, the     number of patients treated with anticoagulants according CHA2DS2-VASc score will be compared     between both arms. Finally, the investigators will assess the number of major adverse     cardiovascular events (MACE), intracerebral hemorrhages and other major hemorrhages, and     all-cause mortality between the arms. End points will be assessed blinded to allocation.      The investigators hypothesise that the MyDiagnostick improves the diagnosis of atrial     fibrillation in primary care and with accordingly treatment will reduce adverse outcomes.   "
77599|NCT02270138|"     The aims of the study: Main objective of the current study is to decrease sedentary behavior     and increase physical activity among mothers and their offspring by using music-to-movement     video program. Primary outcomes of the study are objectively assessed sedentary behavior and     physical activity time measured both in minutes and as a proportion of measurement time.     Secondary outcomes of the study are quantity and quality of self-reported screen time among     mothers and children and motivational quality of music and music-to-movement video.     Additional secondary outcomes are mother's weight, workability, mental health and mood.     Specific aim is to study effectiveness of intervention with accelerometer use only or with a     combination of accelerometer plus music-to-movement video program for mother-child pairs.      Materials and methods: Participants (mother and child -pairs) of the Movement-to-music video     program (Moving Sound) -study will be recruited from the cohort of the original Lifestyle,     counselling and exercise in maternity care (NELLI) -project from 14 municipalities of     Pirkanmaa area. Participants will be randomized in two groups: accelerometer (ACC) vs.     accelerometer plus movement-to-music video program (ACC+DVD) groups. Objective measurement of     sedentariness and physical activity is based on accelerometer. Information on current health     behavior will be based on intervention questionnaires. In the analysis physical activity,     sedentary time and body weight of the intervention and control group will be compared.     Effects of mother's musical (and PA) background and other mediating factors will be analyzed     separately in subgroup analyses.   "
77600|NCT02270125|"     The aim of this prospective study is to evaluate presence and quantity of nano-sized     particles and interindividual differences in their distribution and elemental composition in     human nasal mucosa obtained by mucotomy in patients diagnosed with chronic hypertrophic     rhinosinusitis and to compare the obtained results with control specimen obtained from     stillborn children.   "
77601|NCT02270112|"     Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is     present.      The investigators hypothesize that the activation of the atrial myocardium resulting in the     p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF.   "
77602|NCT02270099|"     This clinical performance study is being conducted to evaluate the performance of the Aptima     Herpes Simplex Viruses 1 & 2 assay for detection of herpes simplex virus (HSV) type 1 (HSV-1)     and HSV type 2 (HSV-2) in swab samples prospectively collected from suspected HSV lesions.     Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima     swab collection kits will be evaluated.   "
77603|NCT02270086|"     The investigators have recently developed an innovative optical molecular imaging platform     (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a     hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact     means of obtaining instantaneous image-based measurements of diagnostically-relevant     biological and molecular information of a wound and surrounding skin tissues for the first     time and could have significant impact on improving conventional wound care, management, and     guidance of intervention. In preliminary preclinical testing, the investigators have     discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the     connective tissue matrix emit a characteristic green fluorescent signal, while most     pathogenic bacterial species emit a unique red fluorescence signal due to the production of     endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast agents     are needed during imaging, making this approach particularly appealing as a diagnostic     imaging method for clinical use.      In the context of this study, PRODIGI is used to assess wound complications in patients     diagnosed with soft tissue sarcoma and treated with pre-operative radiotherapy. Both pre- and     postoperative external beam radiotherapy combined with limb salvage surgery have similarly     high rates of local control in the management of extremity soft tissue sarcoma. The main     acute side effect associated with preoperative radiotherapy is wound healing complications.     Wound care overall is a major clinical challenge and presents an enormous burden to health     care worldwide. The objective of this clinical study is to determine if PRODIGI coupled with     an optical tracking platform has clinical utility in identifying, quantitatively measuring     and longitudinally tracking bacterial imbalance on the patient's intact skin surface at the     location of the surgical resection site for adult patients with lower limb soft tissue     sarcoma treated with preoperative intensity-modulated radiation therapy and limb salvage     surgery and, further, to investigate whether this bacterial imbalance is related to     radiotherapy dose and wound complications.   "
77614|NCT02269943|"     The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously     treated subjects with locally advanced or metastatic nasopharyngeal carcinoma having failed     one to two previous regimens, including platinum-based chemotherapy. Approximately 51-55     subjects will be enrolled according to a Simon two-stage design; if the predefined activity     is met (>4 responses [complete response; partial response {CR/PR}] out of the first 17     evaluable subjects based on independent radiological assessment), then the study will     continue to enroll an additional 34 subjects. If < or = 4 responses out of 17 are observed,     then the study enrollment will be stopped.   "
77604|NCT02270073|"     Background: Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500     years old and can be defined as a specific form of attention that is non-judgemental,     purposeful, and focused on the present moment. It has been well established in cognitive     behavior therapy in the last decades, while it has been investigated in manualized group     settings. Consequently, the demand to investigate mindfulness under effectiveness conditions     in trainee therapists has been highlighted.      Methods/Design: To fill in this research gap, the investigators designed the PrOMET-Study. In     this study, the investigators will analyze the effects of brief, audio-tape presented,     in-session mindfulness interventions conducted by both trainee therapists and their patients     at the beginning of individual therapy sessions in a randomized, controlled longitudinal     design under effectiveness conditions in a total of 30 trainee therapists and 150 patients in     a large outpatient training center. The investigators hypothesize the mindfulness     intervention will have positive effects on therapeutic processes and outcome in contrast to a     progressive muscle relaxation and a treatment as usual group. The investigators will conduct     multilevel modeling to address the nested data structure.      Discussion: The study results could provide important practical implications, as they could     inform ideas on how to improve clinical training of psychotherapists that could be     implemented very, as there is no need for complex infrastructures or additional time     concerning these brief, in-session mindfulness interventions that are directly implemented in     treatment sessions.   "
77605|NCT02270060|"     The purpose of this research study is to:        1. Investigate the effects of a single 20-minute music therapy intervention with a music          therapist on the pain intensity, pain relief, and mood of adult patients with sickle          cell disease as compared to:             1. Adult patients with SCD who listen to their preferred music for 20 minutes without               the presence of a music therapist (music listening group)             2. Adult patients with SCD who receive standard care alone (control group)        2. Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy          intervention for pain management   "
77606|NCT02270047|"     A 4 week double blinded parallel design with an intervention condition and a control     condition will be employed. After having completed screening procedure and a baseline test     day, participants will be randomized to either intervention or control condition. In the     following 4 weeks, the participants will have to consume the distributed food product daily     before completing another test day.   "
77607|NCT02270034|"     This multicenter, open-label, phase Ib trial aims to assess the safety and activity and     safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients     with newly diagnosed glioblastoma.   "
77608|NCT02270021|"     The goal of this study is to prevent over screening and over treatment of young women for     cervical precancers, which can result in psychological distress and has been associated with     future risk of premature deliveries. Current national guidelines recommend that routine     screening be performed at less-frequent intervals and that excisional cervical therapies are     discouraged in young women. The objectives of this study are to examine physician- and     patient-based interventions designed to decrease over screening and over treatment by     increasing adherence to US guidelines for women under 30 years.   "
77771|NCT02267889|"     This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the     treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP     will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac     camera will guide the GP ablation procedure.   "
77609|NCT02270008|"     Anal incontinence affects up to 20% of gravid women during and immediately after pregnancy.     It can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor hygiene     and increased risk for genitourinary tract infection. These women suffer from a combination     of loss of fecal and/or flatal control, with increasing frequency as pregnancy progresses.     Though anal incontinence may subside in the postpartum period, a subset of women will have     continued anal incontinence or recurrence of anal incontinence with subsequent pregnancies or     as they age. As of December 2012, only one study has explored the effects of pelvic floor     muscle training (PFMT) on reducing the development of this condition in the pregnant     population. However, that study took place in Scandinavia with little demographic correlation     to a US population and lacked postpartum followup. Although their results showed little     effect of PFMT on anal incontinence, they recommended further research to be performed prior     to making definitive conclusions.      Multiple studies have explored the effects of PFMT on urinary incontinence, and the general     consensus shows a positive benefit, with a 50% incidence reduction. This study will serve as     an initial test to explore whether such a positive relationship holds for anal incontinence     throughout pregnancy and postpartum period for a diverse population. The format will be a     prospective feasibility trial comprised of a one-time intensive in-person pelvic floor muscle     training course at the first prenatal visit with at home instructions for continued exercise.     This group will be compared to a control group which receives a hand-out regarding PFMT but     no personalized instruction. The progress of the participants and their symptoms of     incontinence will be monitored during pregnancy and at the postpartum visit using     standardized validated pelvic floor questionnaires, based on previously designed surveys. A     sample size of 100 parous women ages 20-35 year old will be randomized to an intervention and     control or standard therapy group. The investigators' hypothesis is that the intervention     group will show a 50% risk reduction, similar to the urinary incontinence studies. The     results of this study will then allow us to design a broader intervention study for which to     study the effects of PFMT and anal incontinence during pregnancy and the postpartum period.   "
77610|NCT02269995|"     This surveillance's objectives are:        1. Unknown adverse reactions        2. Incidences of adverse drug reaction        3. Factors considered to have effect to safety and effectiveness   "
77611|NCT02269982|"     This study will develop a first-in-man CTC-based molecular taxonomy of CRPC in the context of     novel AR-directed therapies, categorize different patterns of resistance in this disease     setting, and describe their evolution over time and treatment.   "
77612|NCT02269969|"     Effective antimicrobial use in the burn population is important since this population is at     an increased risk for infections during their stay in hospital as a result of their burn     injury. Tobramycin is an antibiotic that has activity against common burn wound associated     pathogens, such as Pseudomonas Aeruginosa, and its use is becoming increasingly relevant due     to the increased incidence of bacterial resistance to currently utilized antibiotics. Once     daily dosing of tobramycin has been safely and effectively used in the majority of infected     patients for many years with the proposed benefits of optimized antibacterial activity and     reduced nephrotoxicity compared to traditional dosing. But, the once daily dosing regimen has     yet to be validated in the burn population. The purpose of this study is to validate the     plausibility of once daily tobramycin dosing in the burn population with intent to determine     a safe, effective, and efficient dosing regimen for this population.   "
77613|NCT02269956|"     The purpose of this study is to combine current evidence-based guidelines with adaptive     leadership (AL) training to assist nursing staff to navigate the delicate balance of     necessary technical and adaptive work to improve problematic dementia-related mealtime     symptoms.   "
77642|NCT02269579|"     To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin     pharmacokinetics and their metabolites following administration of CPX-351.   "
77615|NCT02269930|"     The primary outcome of the study is to evaluate the cumulative area under the concentration     time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose     (AUC0-336h), for serum concentrations of BIIB017 and Rebif.      The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of     BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2     weeks in healthy volunteers.   "
77616|NCT02269917|"     The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a     once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine     (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current     regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil     fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1     ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter     [copies/mL]) HIV-1 infected participants.   "
77617|NCT02269904|"     SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation     for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is     a post-marketing study. The subjects will be divided into two groups (Group A and Group B ).     The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and     6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical     gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from     SinoFuan will be analyzed through comparing 3 years DFS of two groups.   "
77618|NCT02269891|"     The purpose of this study is to assess the effectiveness of an herbal combination product     called Nu Femme, on menopausal symptoms in peri-menopausal women.   "
77619|NCT02269878|"     To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas     gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural     mesothelioma (MPM)   "
77620|NCT02269865|"     Study to focus on the defining and managing the neuropsychological abnormalities of myotonic     dystrophy and to find out if the neuropsychological abnormalities have any correlation with     changes seen on Magnetic Resonance Imaging.   "
77621|NCT02269852|"     The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere     2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35     months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.   "
77635|NCT02269670|"     This phase II trial studies how well everolimus and hormone therapy work in treating patients     with hormone receptor positive breast cancer that has continued to spread (progressed) or     returned after a period of improvement (recurred) on everolimus and exemestane hormone     therapy. Everolimus is a chemotherapy drug that may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Estrogen and progesterone are hormones     that can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by     lowering the amount of estrogen and progesterone the body makes. Giving everolimus with a     different type of hormone therapy may be an effective treatment for breast cancer in patients     who progressed on everolimus with exemestane.   "
77622|NCT02269839|"     Tinnitus is a common problem which can have a severe impact on quality of life and for which     there is no truly successful treatment available.      Repetitive transcranial magnetic stimulation (rTMS) is a method of stimulating the brain     through the application of a magnetic field in a series of rapid pulses and may be a valuable     treatment for patients with tinnitus.      The overall aim of this research is to see if patients with tinnitus benefit from treatment     with rTMS, and in particular whether one type (continuous theta burst) is more effective than     other variations of rTMS. Prior to developing a definitive study to address this area a     feasibility study needs to be performed.      The proposed feasibility study aims to determine outcomes necessary to enable development of     a definitive study in the future.      40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control     group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS on     5 consecutive days.   "
77623|NCT02269826|"     Vulvovaginal irritation due to dryness is a frequent complaint among post- and some     premenopausal women. International guidelines recommend non-hormonal products as first line     therapy.      Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal     vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a     non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised,     two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.      The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added     up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects     were planned to be assessed. 120 women should be randomly allocated to either of the two     treatments, each given over a period of 4 weeks.   "
77624|NCT02269813|"     PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on     physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1     and 2 HR-positive HER2-negative breast cancer patients. The design also provides for     assessment of several important secondary indicators. Eligible patients will have their tumor     sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment     before the MammaPrint result is received and taken into consideration for the adjuvant     treatment plan.   "
77625|NCT02269800|"     The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution     clearing the oral colonized bacterium in hospitalized patients with COPD.   "
77626|NCT02269787|"     This research program is intended to improve the treatment engagement and outcomes of     Veterans who receive inpatient detoxification, and decrease their use of VA inpatient and     emergency department services. It is intended to increase the use of substance use disorder     care and 12-step mutual-help groups to benefit recovery, reduce rehospitalizations, and     reduce costs for VA.   "
77627|NCT02269774|"     There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk     factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial     fibrillation after ablation therapy. We have previously shown that simulated OSA triggers     premature atrial beats (PABs) by acute changes in intra-thoracic pressure. Most episodes of     atrial fibrillation are initiated by PABs. However, the origin of PABs induced by     intra-thoracic pressure swings is unknown. This study investigates the origin of premature     atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea     in patients with atrial fibrillation.   "
77643|NCT02269566|"     We will perform double-blinded placebo-controlled randomized clinical trial which evaluates     the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for     allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat,     and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic     rhinitis.   "
77668|NCT02269241|"     To demonstrate the contraceptive efficacy of LF111. To demonstrate the safety and     tolerability of LF111 and assessment of pharmacokinetics of LF111.   "
77628|NCT02269761|"     Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the     Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating     patients with shortness of breath and often provides the timely diagnosis of pneumonia,     pneumothorax, pulmonary edema, among other primary diseases of the lung. There are     limitations with chest radiograph such as large body mass (e.g, obesity) and patient     positioning. On occasion, chest radiography findings are difficult to interpret. Lung     ultrasonography may offer a means of clarifying ambiguous results.      The objective of this study to determine the usefulness of point of care lung ultrasound in     evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.   "
77629|NCT02269748|"     The aim of this randomized-controlled clinical trial is to compare the patient morbidity and     root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with     a coronally advanced flap (CAF) and tunnel technique (TT).      The primary objective of the study is to demonstrate the superiority in terms of the     post-operative course and pain of the CAF+SeCTG when compared to the TT.   "
77630|NCT02269735|"     The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous     (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma     pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to     evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI),     and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in     participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I     general safety, tolerability and other observed data are supportive of progression to Part     II. Part III will be initiated only if Parts I and II general safety, tolerability and other     observed data are supportive of progression to Part III.   "
77631|NCT02269722|"     The investigators will assess the effect of different times of radial clamp post procedure on     radial artery occlusion and bleeding.   "
77632|NCT02269709|"     The purpose of this study is to compare the liver stiffness, (affected by congestion and     fibrosis) in pediatric patients before and after a Fontan heart operation. A new form of     ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver     stiffness.   "
77633|NCT02269696|"     The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for     perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the     incidence of pain and life satisfaction will be evaluated.   "
77636|NCT02269657|"     The EOS® imaging system, a new imaging modality which offers low dose, weight bearing and     full body X-ray imaging, requires a new standing position where patients put their hands and     forearms on the wall vertically for stability. Although this method provides enough support     for the patients during the extended X-ray acquisition time, its impact on the postural     balance and sagittal profile of the spine and sacro-pelvic parameters has not been evaluated.     The goal of this study is to identify the impact of patients' arm positioning on the sagittal     profile and postural balance of the patient and subsequently propose a standardized method     for full spine X-ray acquisition in the EOS® imaging system.   "
77637|NCT02269644|"     This study will be a double-blind, randomized, multicenter trial to assess the safety and     efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of     azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12     hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of     Community Acquired Bacterial Pneumonia.   "
77638|NCT02269631|"     This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger     and other indicators of health over the course of eight weeks, compared to a more     conventional healthy diet.   "
77639|NCT02269618|"     The aim of this randomized control study is to determine the feasibility and efficacy of an     innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease     (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the     study and followed for 4 months and for additional 2 months of follow-up. The primary outcome     is to improve tolerance capacity   "
77640|NCT02269605|"     Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal     is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1     infected patients receiving antiretroviral treatment.   "
77641|NCT02269592|"     Blood cancers occur when the molecules that control normal cell growth are damaged. Many of     these changes can be detected by directly examining parts of the cancer or cells in blood.     Several alterations that occur repeatedly in certain types of blood cancers have already been     identified, and these discoveries have led to the development of new drugs that target those     alterations. More remain to be discovered.      Some of these abnormalities include alterations in genes. Genes are the part of cells that     contain the instructions which tell the investigators bodies how to grow and work, and     determine physical characteristics such as hair and eye color. Genes are composed of DNA     letters that spell out these instructions. Studies of the DNA molecules that make up the     genes are called molecular analyses. Molecular analyses are ways of reading the DNA letters     to identify errors in genes that may contribute to an increased risk of cancer or to the     behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur     in the genes that are passed from parent to child. This research study will examine both     kinds of genes. The best way to find these genes is to study large numbers of people. The     investigators expect that as many 1000 individuals will enroll in this study.      This research study is trying to help doctors and scientists understand why cancer occurs and     to develop ways to better treat and prevent it. To participate in this study the participant     must have cancer now, had it in the past, or are at risk of developing cancer. The     participant will not undergo tests or procedures that are not required as part of their     routine clinical care. The investigators will ask the participant to provide an additional     sample from tissue that is obtained for their clinical care including blood, bone marrow, or     tissue sample. The investigators will also ask for a gentle scrape of the inside of their     cheek, mouthwash or a skin sample to obtain their germline DNA   "
77645|NCT02269540|"     The investigators will be looking at MAO-A density before and after seven weeks of treatment     with an antidepressant and dietary supplement. MAO-A is an enzyme that breaks down brain     chemicals that regulate mood. MAO-A density is elevated in patients with major depressive     episodes (MDE) secondary to major depressive disorder (MDD). Many remain treatment resistant     with common antidepressant treatments and we think it may be due to poor targeting of brain     pathologies. We want to test if adding a dietary supplement may normalize MAO-A.   "
77646|NCT02269527|"     The use of live music in SICU might affect the perception of noise, which may reduce staff's     stress level and further decrease the possibility of clinical errors, reduce patient's     anxiety and perception of pain as well as increase compliance from patient and family. Live     music might also enhance the quality of stay and promote a holistic healing process for the     patient.   "
77647|NCT02269514|"     The purpose of this study is to measure plasma nicotine uptake parameters, physiological     measures, and subjective effect measures in smokers during and following a single ad libitum     use of three electronic cigarettes versus combustible cigarettes and nicotine gum.   "
77648|NCT02269501|"     The purpose of this study is to study the effect of a physical exercise program on patients     suffering from migraine and co-existing tension-type headache and neck pain. The     investigators hypothesized that migraine patients are ofte physically inactive because of     their headache and that they will benefit from a specific exercise program.   "
77649|NCT02269488|"     This open-label, single arm, multicenter study will enroll approximately 100 subjects. The     study is designed to gather the safety and tolerability data in Japanese children 2 to 6     years of age that would support approval of MEDI3250 in Japan.   "
77650|NCT02269475|"     The study is designed to gather the efficacy, safety and tolerability data in Japanese     children 7 to 18 years of age that would support approval of MEDI3250 in Japan.   "
77651|NCT02269462|"     Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented     with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis     (PEP). However, the pharmacokinetics of certain ARVs is associated with marked     inter-individual variability. This variability has been associated with single nucleotide     polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and transcriptional     regulators. Pregnancy is also associated with additional changes in pharmacokinetics. The     resulting sub-therapeutic or supra-therapeutic drug exposures may have serious consequences     for virological control, MTCT, emergence of drug resistance, and toxicity. Foetal and infant     exposure to maternal ARV during pregnancy and breastfeeding is believed to play a role in the     prevention of mother-to-child transmission of HIV (PMTCT). However, such exposures may also     result in toxicity. For example, efavirenz is contraindicated in children less than 3 years     old or 10kg but transferred to breastfed babies through breast milk. On the other hand,     double exposure to nevirapine from breast milk and PEP may also predispose breastfed infants     to nevirapine-associated toxicity.      In the proposed study, the influence of selected SNPs in certain drug disposition genes on     the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as     the level of infant exposure to both drugs through breast milk, will be studied. Mathematical     models will be developed to predict potential dose optimisation strategies during pregnancy,     and to predict infant exposure to maternal drugs through breast milk.   "
77655|NCT02269410|"     The obesity epidemic has grown rapidly in the United States, and is associated with increased     morbidity and mortality rates. Bariatric surgery (BS) has emerged as the most effective     treatment for severe obesity. Surgical weight loss (WL) is very significant (~40-50kg) during     the first 6-12 months after surgery. The adequate amount of dietary protein during the active     period of surgical weight loss is not known. Dietary protein affects body weight regulation:     satiety, thermogenesis, energy efficiency and body composition. During diet-induced     energy-restriction, sustaining protein intake (PI) at the level of requirement (0.8g /kg     ideal body weight (IBW)/ day) appears to preserve fat free mass (FFM) during active WL. PI     above requirements (1.2g protein/Kg IBW/ day) results in favorable body composition changes,     with greater decrease in fat mass and preservation of FFM, but without effecting WL. Dietary     PI 0.8g/day has been associated with greater satiety and increased energy expenditure (EE)     during calorie restriction. In this randomized prospective study, the investigators will     evaluate the effect of PI on nitrogen balance, body composition, EE and satiety in 40 women     undergoing either Gastric Bypass or Vertical Sleeve Gastrectomy, assigned to high protein     supplementation (PRO-S), high PRO-S (1.2g /kg IBW/day) or standard- based current guidelines     -PRO-S (0.8g /kg IBW/day). PRO-S will be supplied for 3 months after surgery. Outcome     measures including nitrogen balance, body composition changes and satiety will be assessed at     pre-surgery, and at 3, 6 and 12 months post-surgery. These results will help provide     evidence-based data on safe and optimal levels of protein supplementation after BS   "
77656|NCT02269397|"     The primary goal of this observational study is to establish the accuracy of CNS-specific     Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The     target population is patients who have been newly referred to the Penn Epilepsy Center or     patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an     epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to     allow the study team to collect information from their medical record, and to provide at     least one blood sample.   "
77669|NCT02269228|"     To investigate the occurrence of dipyridamole associated headaches in healthy subjects using     a titration scheme or not   "
77670|NCT02269215|"     Safety, tolerability and pharmacokinetics of BIII 890   "
77671|NCT02269202|"     To assess the pharmacokinetics of midazolam with/without concomitant administration of     crobenetine   "
77657|NCT02269384|"     The prevalence of chronic pain has been estimated at 30% in the US and these values may under     report the true prevalence of people who experience long term pain as additional research has     shown that 73% will have a reoccurrence of symptoms within 12 months of the original injury     indicating that while the pain and symptoms may resolve, additional impairments or issues may     underlie the symptoms.      Biopsychosocial factors such as depression, post traumatic stress, anxiety, pain     catastrophizing, and negative emotions have been closely linked to pain and can influence a     patient's pain perceptions. Along these lines, the memory of past experiences and trauma     potentially play a large role in these biopsychosocial responses. Research is evolving and a     strong correlation has been established between chronic pain and prior history of trauma or     abuse and also non-traumatic incidents such as motor vehicle accidents and injuries/surgical     procedures. This has led to speculation and research that explores how a variety of life     events may become stimulants for long-term alterations in the processing and manifestation of     pain and how they may have an enduring impact on physical health outcomes.      The proposed research will add to the body of knowledge underlying the association between     pain, memory, autonomic system, and neuromuscular function. The goal of this project is to     study the relationship between pain memory systems, specifically acute pain, short-term     memory of pain, and long term pain memory, and their effects upon neuromuscular and autonomic     system responses in the body.   "
77658|NCT02269371|"     Male and female DoD beneficiaries ages 18 years or older, who are referred for a standard of     care weight loss intervention for treatment of obesity will be recruited. Subjects will be     randomized into one of two groups receiving either a standard of care weight loss     intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control     Point/Hunger Point or receiving a standard of care weight loss intervention plus sham     auricular acupuncture. Subjects will receive treatment in accordance with their randomization     group for 12 weeks then have one additional follow up visit at week 24. The following     measures will be obtained: height, weight, waist circumference, and Body Mass Index will be     calculated.   "
77659|NCT02269358|"     The goal of the present study is to evaluate if addition of methotrexate can restore     remission after loss of response to infliximab after dose escalation.      another goal is to evaluate if low dose methotrexate can maintain remission achieved by     regular dose methotrexate by 6 months.   "
77660|NCT02269345|"     The investigators propose to complete a randomized controlled trial to compare battlefield     auricular acupuncture at five points in right ear and five points in left ear (cingulate     gyrus, thalamus, omega 2, point zero, and shen men) plus standard of care, versus standard of     care alone, for symptomatic treatment of stent pain in postoperative ureteral stent patients.     Male and female DoD beneficiaries ages 18 years or older, who are scheduled for elective     urologic surgery that would be expected to have the routine placement of a ureteral stent     (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone, ESWL     of stone greater than 10mm) will be recruited. Subjects will be followed up at 24 hours post     surgery, 48 hours, 1 week, 1 month, and 1 month post surgery. The investigators will ask     subjects to rate their pain level on a 0-10 analogue scale, the investigators will assess via     the Ureteric Stent Symptoms Questionnaire (USSQ) subjects' urinary urgency, urinary     frequency, and quality of life. The investigators will ask subjects how many pills they have     taken for their pain including the quantity and dose to assess a reduction in pain medication     use.   "
77661|NCT02269332|"     The investigators will recruit DoD beneficiaries 18 years or older, that have been referred     for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have     no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to     determine if there is an association between the level obtained and findings on colonoscopy,     or previous findings (if repeating).   "
77662|NCT02269319|"     The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid     in the treatment of adult patients with acute bacterial skin and skin structure infections   "
77664|NCT02269293|"     The purpose of this study is to test the safety of the investigational drug, selinexor     (KPT-330), in combination with carboplatin and paclitaxel chemotherapy, where paclitaxel will     be given at two different dosing schedules and selinexor will be given at two different     dosing schedules. Carboplatin and paclitaxel chemotherapy is a commonly used therapy for the     treatment of advanced or recurrent ovarian, fallopian tube, primary peritoneal, or     endometrial cancer. The investigators want to find out what effects, good and/or bad,     selinexor has on the patient and the cancer.   "
77665|NCT02269280|"     The goal of this clinical research study is to compare how 2 different drugs, decitabine and     azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS.     The safety of each study drug given on these schedules will also be studied.   "
77666|NCT02269267|"     This is a non-randomized, prospective, single-group longitudinal study. The purpose of this     study is to improve the decision making process used by physicians and patients when they are     considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.   "
77667|NCT02269254|"     The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported     excellent medium and long-term results in clinical studies and in implant registries all     around the world. As a follow-up of the NexGen TKR, an improved design has recently been     introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used     successfully in about 20.000 patients, but results from independent clinical studies have not     been reported yet.      The objective of this study is to accurately assess and compare migration, kinematics,     prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing,     cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed     bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer,     Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two     TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and     compare clinical data, kinematics, prosthesis placement and patient reported outcome     measures.      This study is designed as a single-blind randomized trial between the Persona PS total knee     prosthesis and the well-established NexGen total knee prosthesis.      Different sample sizes are used for the different parts of this study:        -  30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for          RSA        -  15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for          Fluo      The study population will consist of patients with symptomatic osteoarthritis of the knee     scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical     Center. Annually 40 TKA procedures are performed in our department, of which about 70% is     Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be     accomplished within a 2 year period.      Main study parameters/endpoints are:        -  Migration, measured by means of RSA.        -  Prosthesis placement and bone resection measured by means of CT and caliper measurements          of the resected bone parts.        -  In vivo kinematics by means of fluoroscopy.        -  Patient Reported Outcome Measures by means of questionaires.   "
77674|NCT02269163|"     A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability,     Efficacy, and Pharmacokinetics of ProMetic BioTherapeutics Immune Globulin Intravenous     (Human) 10% in Adults and Children with Primary Immunodeficiency Diseases (PIDD) to assess     the tolerability, safety, efficacy and pharmacokinetics of ProMetic's IGIV in subjects with     PIDD. IGIV is intended for the treatment of children and adults with Primary Immunodeficiency     Diseases (PIDD) who require IgG (Immunoglobulin G) replacement therapy   "
77675|NCT02269150|"     The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent     the future development of CDI. This is also known as fecal bacteriotherapy or stool     transplant.   "
77676|NCT02269137|"     To characterize the functional outcomes and prognostic factors for convulsive status     epilepticus (SE) and to further develop and validate a simple and practicable scoring system     for outcome prediction.   "
77677|NCT02269124|"     Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on     quality of life, school performance and behavior. Despite this knowledge, it remains unclear     how to best manage this common problem. There has been much debate regarding this issue with     many programs recommending preferential seating in the classroom and use of a     frequency-modulated (FM) system to amplify the teacher's voice in the classroom (conventional     measures), and others recommending these accommodations in addition to use of a hearing aid     for amplification (amplification). There is very limited research to support or refute the     efficacy of a hearing aid in improving measurable academic, behavioral, or quality-of-life     (QOL) outcomes in children with UHL. We propose a study evaluating the impact of hearing aid     use in school-aged children (ages 6-12 years) with mild to moderately severe UHL. In this     study, subjects will be randomized to receive either conventional measures or conventional     measures plus amplification. After a three month period, the groups will be reversed, with     each subject serving as their own control. Outcome measurements will include patient reported     disease-specific QOL reported by patients, parents, and teachers using validated survey     instruments at regular intervals throughout the study period.   "
77678|NCT02269111|"     This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in     assessing disease in patients with tumors that have spread to the brain (brain metastases).     In addition to routine care brain imaging of the brain, this study will include advanced     multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the     tumor. Performing extra scans during MRI provides more information about the metastases and     may better predict treatment response.   "
77679|NCT02269098|"     A 4 week prospective, randomized controlled study was carried out to assess the impact of a     care delivery intervention which focused on blood glucose (BG) management among adults with     type 2 diabetes presenting to the Emergency Department (ED) with BG > 200mg/dL (11.1 mmol/L).     The intervention was designed by a multi-disciplinary team of ED physicians and nurses,     endocrinologists and diabetes educators. The intervention incorporated three components: a     guideline-based algorithm for diabetes medication management; survival skills diabetes     self-management education (DSME); and support for health system navigation. The control group     received usual care per the ED's policies and procedures for management of high blood     glucose.   "
77680|NCT02269085|"     The goal of this clinical research study is to find the highest tolerable dose of carfilzomib     and ibrutinib that can be given to patients with relapsed or refractory MCL.      Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease.   "
77681|NCT02269072|"     The proposed study is a physiologic investigation of the effects of testosterone on the     natriuretic peptide system. The hypotheses of the study are that testosterone administration     will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks     in duration.   "
77682|NCT02269059|"     This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV)     infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily     administration of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV     viral load.   "
77684|NCT02269033|"     The purpose of this study is to assess the efficacy of a patient navigator program that     uses a trained community lay health worker to assist Hispanic patients in utilizing cancer     care services. This study is a two part study. The first part of the study consists of a     retrospective data collection procedure called baseline clinical chart audit of 50 Hispanic     women over 18 years of age who have had a mammography abnormality classified as BI-RADS 3, 4     or 5. These data will be drawn from the study clinic's existing records and will serve as     baseline data for subjects recruited during the course of the study. The second part of the     study, the intervention group, involves the recruitment of 50 low-income, Hispanic women who     receive abnormal breast cancer screening results (also classified as BI-RADS 3, 4 or 5) from     screening services at local community health clinics. Participants will have significantly     higher compliance rates and significantly shorter time lags and between an abnormal screening     result, and confirmatory screening tests and commencement of treatment, compared to our     baseline. The investigators expect at least a 12% increase in after-screening compliance rate     and a 25% reduction in time lags in the treatment group, in relation to the pre-intervention     baseline assessment.   "
77685|NCT02269020|"     The main hypothesis of this study is that it is possible to make a unilateral selective     dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via     the da Vinci robotic system to reduce scarring, while respecting patient safety.      Feasibility will be assessed by two combinded criteria: 1) performance of the surgical     procedure respecting the different stages of visualization and dissection of key anatomical     elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the     dissection.   "
77781|NCT02267759|"     McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation,     thereby reducing intubation time and complications, especially in patients with a difficult     airway. This study was performed to investigate whether McGrath videolaryngoscopy is superior     to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal airways, as     judged by the time to intubation and ease of intubation.   "
77686|NCT02269007|"     Influenza is an acute respiratory disease caused by influenza viruses. There are three types     of the virus including A, B and C. Both type A and type B viruses can cause acute febrile     respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough,     sore throat, nasal congestion and general malaise.      Influenza can periodically cause worldwide pandemic. For nearly a century, the influenza     virus had occurred four large variation, causing three world pandemic. Studies have shown     that since 1957, most of those new variants of influenza virus started in China, which is     recognized by the world to have high incidence of influenza. At present, trivalent influenza     vaccines are widely used in China. They only contain two kinds of type A virus antigens and     one type B virus antigen. But since 2000, two kinds of type B strains (Victoria and Yamagata)     have caused an alternating cycle in different seasons. Gradually, evolved from the original     single lineage of influenza B virus B/Yamagata, two distinct antigenic lineages-B/Victoria     and B/Yamagata have alternately dominated or caused a mix of popular lineage. These two     lineages have little or nearly no cross-protection. Therefore, trivalent influenza vaccines     may not cover the popular strains of influenza B virus, whereas quadrivalent influenza     vaccines will help to simultaneously prevent two kinds of type A viruses and two kinds of     type B virus.   "
77687|NCT02268994|"     a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized,     double-blind, placebo-controlled period (Randomized Period), followed by an 8-week     open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate)     (Extension Period).   "
77688|NCT02268981|"     This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to     a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.   "
77689|NCT02268968|"     The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on     reducing pain associated with the application of nasal CPAP in preterm infants   "
77690|NCT02268955|"     The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in     the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous     ibuprofen will provide a clinically significant drop in self-reported patient pain level as     measured by the visual analog scale.   "
77691|NCT02268942|"     This is a prospective, multi-center,single arm study that will evaluate the thoracotomy     implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD®     System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support     (INTERMACS®) protocol and database.      All participating centers will be current INTERMACS® sites in good standing and will follow     the INTERMACS® protocol and procedures.   "
77692|NCT02268929|"     This study is a German, prospective, multicenter, controlled, cluster-randomized,     interventional comparative study evaluating the efficacy and benefits of integrated PDM care     by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into     two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.   "
77693|NCT02268916|"     The purpose of the study is to investigate if the investigators can improve physical activity     and social participation level among Veterans with diabetes.   "
77707|NCT02268734|"     Vandetanib has been approved for patients with unresectable and/or metastatic medullary     thyroid cancer (MTC) by the Food and Drug Administration, by the European Medicines Agency     and, very recently, it has been licensed also by the Italian Regulatory Agency (AIFA) for the     use in Italy. Vandetanib is an orally tyrosine kinase inhibitor (TKI) of vascular endothelial     growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and RET signaling.      Circulating microRNAs levels could be influenced by the treatment procedures and we     hypothesize that a TKI therapy could influence the levels of circulating miRNAs as well.      Aim of this project is to seek non-invasive molecular markers potentially useful as     prognostic tools for metastatic MTC patients.   "
77769|NCT02267915|"     1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or          partial response with the (R-GemOxD)-induction therapy        2. Secondary endpoints:             1. Quality of response obtained after subcutaneous Rituximab maintenance.             2. Progression-Free Survival (PFS)             3. Overall Survival (OS)             4. Time to Next Therapy (TTNT)             5. Value of MRD in the disease outcome             6. Toxicity   "
77694|NCT02268903|"     Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about     75000 cases in France and a short-term mortality rate of about 10%. Death is usually related     to an acute right ventricular (RV) failure due to the increase in right ventricular     afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in     case of shock. However several studies suggest that fluid expansion may worsen acute RV     failure by increasing RV dilatation and ischemia and left ventricular compression by RV     dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of     fluid expansion. In a preliminary study published by our group, we showed that diuretic     treatment in the setting of PE with RV dilatation is safe and is associated with an increase     in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients     with oliguria. This may be related to the decrease of ventricular interdependence and     enhancement of both LV and RV function.      The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in     patients referred for acute PE with RV dilatation compared to placebo. The combination of     urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it     indicates the disappearance of pre-shock symptoms and is therefore associated with a lower     event risk. Thus, it allows early discharge of the patients from the intensive care unit.   "
77695|NCT02268890|"     The purpose of this study is to evaluate the pharmacokinetic (PK-the study of the way a drug     enters and leaves the blood and tissues over time) characteristics of bortezomib when     administered intravenously in Taiwanese participants with multiple myeloma (cancer of the     types of cells normally found in bone marrow).   "
77696|NCT02268877|"     The goal of this project is to compare the efficiency of pelvic ultrasounds performed by     emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds     performed by the department of radiology.   "
77697|NCT02268864|"     The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen     of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12     (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected     participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).   "
77698|NCT02268851|"     This research study will be evaluating the safety and efficacy of a study drug called     TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible     treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle     Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.   "
77699|NCT02268838|"     This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study.     This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This     study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and     400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single     dose of the study drug under fasted condition. Following 3 days of washout period, subject     will receive the study drug once daily for 7 days starting on the fifth day from the single     dose administration.      For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period     before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed     condition, to evaluate food effect of the study drug.   "
77700|NCT02268825|"     This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6     followed by a safety expansion open label, nonrandomized trial with MK-3475 at MTD in     combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI     malignancies (pancreatic, gastro esophageal, colorectal/appendiceal adenocarcinoma and     biliary carcinoma) to assess response rate, clinical benefit rate, progression free survival     and overall survival. The safety expansion cohort will assess the effect of the addition of     celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.   "
77701|NCT02268812|"     This is an open-label, long-term, multi-centre multi-national postmarketing observational     registry. The objective of this study is to monitor the long-term efficacy, safety,     tolerability and quality of life outcomes associated with Prialt and other analgesics     utilised in the intrathecal management of severe chronic pain.   "
77702|NCT02268799|"     The purpose of this study is to determine if there is a rise in serum high sensitivity     troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock     therapy) used for patients with atrial fibrillation. This will help us determine if direct     current cardioversion results in damage to the heart muscles in a sufficient amount to cause     a rise in high sensitivity troponin T.   "
77703|NCT02268786|"     The purpose of the current study is to evaluate the effect of preimplantation genetic     screening (PGS) by next generation sequencing (NGS) compared to standard morphological     assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All     embryos will be vitrified and a single embryo transfer (SET) will be performed with either     screened or unscreened embryos depending on randomization.   "
77704|NCT02268773|"     To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole     (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect     on inhibition of thromboxane B2 formation   "
77705|NCT02268760|"     To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW        1. In rising single doses        2. With and without a 64 g fat breakfast at one selected dose   "
77706|NCT02268747|"     This is an open label, monocentric, uncontrolled phase II trial with Dacomitinib, a pan-HER     inhibitor, in unresectable or metastatic skin SCC.      HER2 expression is common in skin SCC, being reported with high rates, even if in small     studies.      Coexpression of EGFR, HER2 and HER3 is present in skin SCCs but not in normal skin and it     could be associated with the malignant phenotype. In this frame Dacomitinib could play a role     in the increase of the response rate.   "
77766|NCT02267954|"     The investigators aim to discover if people of different demographic levels are more or less     attentive to changes in calorie information vs. changes in price information on a restaurant     menu. The investigators will record whether the calorie/price change was noticed or not, as     well as how quickly the calorie/price change was noticed, depending on condition and     individual differences.   "
77767|NCT02267941|"     To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese     patients.   "
77708|NCT02268721|"     The research and Innovation program Food'n'Go - Empower aims to develop, test and implement a     health technology solution for involvement and increased empowerment of elderly patients and     their relatives. The focus is on frequent issues for this group of patients, in the first     phase focusing on nutrition and physical activity. Later, the solution will include pain     management, management of sleep problems, management of medication, prevention of confusion     and coordination of the treatment and care course across sectorial borders. The technology is     a tablet-computer, operated by the patient by means of a number of app-like software     applications.      The program received in the summer of 2013 one of the Capital Region OPI funding for design     and development of the prototype, which is now ready and looking very promising. The next     step is a pilot feasibility study testing the usability and acceptability as well as effect     during hospitalisation and at home after discharge. The present study - Food'to'Go     investigates the intervention in the post-discharge period.      Aim The overall aim of Food'n'Go research- an innovation programme is to develop, test and     implement innovative information technology solutions to increase participation and     empowerment of older patients and their families, in relation to frequent problems during     hospitalisation and the time after.      The aim for the substudy Food'to'Go is to test the feasibility and efficacy of ICT-supported     energy- and protein-enforced home-delivered main and in-between meals on older patients,     discharged from acute hospitalisation in medical wards. Hereunder:        -  Test the technology's relevance, suitability, acceptability and ease of use in relation          to the target group        -  Test the communication loop between patient and kitchen, and relatives external access          to the related website      Welfare and health technologies are often directed at solving problems and meeting the needs     of society's most vulnerable groups, often not familiar with computers. We will, in addition     to developing the technological solution, examine user-related barriers and preferences for     health technology and try to find solutions that can increase older people's possibilities     for using technology and achieve empowerment. The program incorporates research and     innovation in an iterative process where research provides answers and solutions to the     issues arising in relation to the development of the technology (innovation) and the use of     it.   "
77709|NCT02268708|"     Evaluation of post-operative respiratory complications after thoracic surgery for pulmonary     resection in patients with COPD      Introduction: Postoperative pulmonary complications following pulmonary resection occur in     12-40% of cases. Some risk factors such as COPD are well identified. It has been shown that     COPD patients with a history of frequent exacerbations are more likely to develop     exacerbations. No study has evaluated the rate of patients called 'frequent exacerbators'     among COPD patients requiring pulmonary resection and the relations between exacerbations     history and incidence of acute respiratory postoperative complications.      The main objective is to determine the frequency of pulmonary postoperative complications     (atelectasis, acute respiratory failure, pneumonia) following lung resection in COPD     patients. The secondary objectives are to determine the frequency of extra pulmonary     postoperative complications and the prevalence of the 'frequent exacerbator' phenotype in     this population, as well as its relation with the risk of post-operative complications.      Materials and Methods: This is a prospective, observational, single-center study, of patients     with COPD hospitalized for elective thoracic surgery in the center of Thoracic Surgery,     Hôpital Cochin. The inclusion criteria are: male or female aged more than 40 years, permanent     airflow obstruction as defined by an FEV/FVC ratio < 70% after bronchodilator. Collected data     will be: COPD symptoms (dyspnea score, exacerbations) by a questionnaire given to the patient     during the anesthesia consultation, COPD severity scores, comorbidities, per operative data,     postoperative complications, hospitalization and intra-hospital mortality.      Perspectives: This work will provide information on the risk of postoperative complications     in patients with COPD and the influence of the 'frequent exacerbator' phenotype. This will     help adapting preventive care to the COPD subtype .   "
77710|NCT02268695|"     This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx)     versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in     recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while     the other half will be treated by EXTREME regimen.   "
77748|NCT02268188|"     This pilot clinical trial studies the Harvesting Health Program in improving the diet and     physical activity level of cancer survivors. Nutrition and physical activity classes and the     opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and     vegetable consumption and physical activity levels. Studying the participation rates and     changes in participants' eating and physical activity habits may help doctors learn whether     the program has an effect on participant lifestyle.   "
77711|NCT02268682|"     Kidney transplantation, especially living donor kidney transplant (LDKT), offers patients in     end-stage renal disease (ESRD) 3 to 17 additional years of life and improved quality-of-life     compared to remaining on dialysis. Unfortunately, LDKT education in dialysis centers occurs     inconsistently, especially for minorities and those who are socioeconomically disadvantaged.      To ensure more informed transplant decision-making, through a previous HRSA grant, Dr.     Waterman designed the Explore Transplant (ET) education program based on the Transtheoretical     Model of Behavioral Change. Through a previous trial, an earlier version of ET, delivered     face-to-face with patients while they were undergoing dialysis, was shown to increase     patients' DDKT and LDKT knowledge. However, additional research exploring dialysis providers'     ability to integrate ET into their care revealed that multiple patient, provider, and system     barriers limited the degree to which transplant education could be improved.      Thus, a more comprehensive case-management program to educate patients through external     organizations may be needed to supplement ongoing transplant education within dialysis     centers. For this grant, the investigators propose to test the effectiveness of another     replicable solution for disseminating ET education on a broad scale: Partnering with a large     health insurance organization to deliver video-guided transplant education supported by     telephone and mail. The Missouri Kidney Program (MoKP) is a state-wide organization whose     mission is to serve and educate kidney patients, particularly those who are economically     disadvantaged. Since MoKP subsidizes the costs of dialysis medication for low-income ESRD     patients, they operate as an insurance company would with respect to their 1200-patient     member group. With 900 dialysis patients currently being managed by the MoKP, the     investigators will conduct an eight-month, group randomized controlled trial (GRCT) where 540     patients will be randomized to receive: (1) no additional education other than from their     dialysis center; (2) a video-guided, four-part Explore Transplant (ET) program delivered via     the internet or mail; or (3) a video-guided ET program with discussion facilitated by a     telephone case manager.   "
77712|NCT02268669|"     The conceptual hypothesis of this study is that primary angioplasty is superior to a combined     strategy of immediate thrombolysis followed by routine angioplasty in patients with     ST-segment elevation acute myocardial infarction (STEMI), even with the inherent delay of the     transfer of these patients.   "
77713|NCT02268656|"     Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after     injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI)     pump. Effect site concentraion of propofol start from 5 and changes the concentration as     previous response to i-gel insertion as up and down methods   "
77714|NCT02268643|"     In the present study, the investigators will screen breast cancer of the Chinese women based     on ultrasound and aim to compare the risk evaluation model of PUMCH model which was     established by our previous work with other risk models.   "
77715|NCT02268630|"     This prospective observational follow-up study is designed to assess the long-term outcomes     after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant     (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).      The study will not be testing any formal hypothesis.   "
77716|NCT02268617|"     Individuals with Dementia with Lewy Bodies (DLB) and Huntington's disease (HD) experience     balance and walking problems that lead to falls. Treadmill walking has demonstrated     improvements in balance and walking and fall risk in individuals with Parkinson's disease     (PD), suggesting that it may be beneficial for individuals with DLB and HD. In PD subjects,     changes in gait parameters have been noted after only one treadmill training session. The     investigators propose a pilot study to investigate the safety, feasibility, and utility to     improve mobility and fall risk of a single session of treadmill walking in individuals with     DLB and HD.   "
77717|NCT02268604|"     Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL   "
77718|NCT02268591|"     Aim 1: Determine whether sleep enhances learning across a range of cognitive domains in     healthy subjects.      Aim 2: Determine whether low-frequency transcranial stimulation (TCS) delivered during slow     wave sleep (SWS), compared to sham stimulation, enhances learning outcomes as indexed by a     complete neuropsychological battery of tests in epilepsy patients and healthy control     subjects.      Aim 3: Determine whether low-frequency TCS delivered during SWS, compared to sham     stimulation, enhances sleep architecture associated with enhanced memory consolidation (ie.     increased coherence of slow wave activity and increased frequency of sleep spindles).      Aim 4. Determine whether low-frequency TCS during sleep results in a more distributed memory     representation, as suggested by increased hippocampal-perirhinal connectivity on fMRI in     human subjects.      Aim 5. Determine whether the frequency of interictal activity during sleep in epilepsy     subjects is associated with the degree of cognitive benefit conferred by SWS.      These studies will provide critical pilot data on whether non-invasive brain stimulation     protocols previously tested in healthy subjects can be extended to epilepsy patients for     potentially therapeutic cognitive benefits.   "
77719|NCT02268578|"     Memory difficulty ranks among the most common complaints for patients with temporal lobe     epilepsy. While these cognitive problems may affect quality of life more than seizure     frequency, no effective therapy exists. Transcranial Direct Current Stimulation (tDCS) is a     method of safe, noninvasive, and painless brain stimulation delivering low intensity direct     current through scalp electrodes to modulate brain activity. Several recently published     studies demonstrate the enhancement of working memory and mood with stimulation of the     frontal region of the brain. Furthermore, tDCS has never been reported to have induced a     seizure. The aim of our study is to determine whether real tDCS can improve memory function     and mood. The investigators are enrolling patients with well-controlled temporal lobe     epilepsy who have not undergone brain surgery.   "
77720|NCT02268565|"     The main purpose of this study is to learn about the effects of sleep disruption (two days in     a row where sleep is shortened and disrupted) on inflammation, mood (how you feel), and pain     processing (your own experiences/perceptions of pain). In this research project, we are     trying to figure out if we can change the effects of sleep disruption on inflammation, mood,     and pain. Therefore, we will study whether taking a low-dose aspirin pill every day over 2     weeks can change how we respond to sleep disruption. For example, does the sensitivity to     pain (e.g., how intense the feeling of pain is if we put our hand in very hot or very cold     water) change with sleep disruption, and can low-dose aspirin influence this change. We are     also interested in seeing how inflammation changes in relation to your own perceived     experience of pain.   "
77721|NCT02268552|"     An open-label, multi-part, first-in-human study of oral LMI070 in infants with Type 1 spinal     muscular atrophy. The purpose of this study is to evaluate the safety, tolerability,     pharmacokinetics (PK), pharmacodynamics (PD) and efficacy after 13 weeks; and to estimate the     Maximum Tolerated Dose (MTD) and optimal dosing regimen of orally administered LMI070 in     patients with Type 1 SMA.   "
77749|NCT02268175|"     This study is comparing the effectiveness of enzalutamide with or without abiraterone acetate     for men with high-risk, localized prostate cancer.   "
77722|NCT02268539|"     This is a pilot study designed to investigate the effectiveness of the nMARQ Pulmonary Vein     Isolation system in the treatment of Paroxysmal Atrial Fibrillation (AF) at different     ablation settings.      AF is a common condition which causes a fast and erratic heartbeat. There are estimated to be     50,000 new cases diagnosed per year in the UK. The fast heart beat can cause symptoms such as     palpitations, lightheadedness, chest pains, shortness of breath and fatigue.      Catheter ablation is a technique used for the control of AF. In this procedure a catheter (a     long thin wire) is passed into the chambers of the heart via a large blood vessel in a leg.     The tip of the catheter can destroy tiny sections of heart tissue that may be the source or     trigger of the abnormal electrical impulses. One of the challenges of AF ablation is to     maximize success rates, as such there is currently rapid advances in technology to carry out     this procedure.      Different catheters exist which deliver this energy in different ways. This study uses one     such system to perform this procedure. It is called the nMARQ system for Pulmonary Vein     Isolation produced by Biosense Webster. Currently this system is used in practice in the UK     for patients with this medical condition.      What we seek to research is when ablating what is the optimum setting to perform ablation at.     There is currently no data to guide best clinical practice in this area.   "
77723|NCT02268526|"     This study is designed to test if CSJ148 can prevent HCMV replication after stem cell     transplantation.   "
77724|NCT02268513|"     It has been argued that social relationships are important to health and well-being. This     study will investigate links between social networks and cardiovascular disease risk factors     in South Asians, the second fastest growing ethnic group in the US and one with disparate     rates of coronary heart disease. Identifying and understanding the links between social     networks and cardiovascular disease is key to the development and testing of family- and     community-level prevention interventions for minorities.   "
77725|NCT02268500|"     A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with     heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and 20     patients to high dose influenza vaccine. Post-vaccine antibody measurements will be assessed,     as well as tolerability differences between groups.   "
77726|NCT02268487|"     The objective of this project is to assess the occurrence of early improvement within the     first two weeks of antidepressant treatment and to correlate this improvement with favorable     therapeutic outcome at the end of the acute and treatment continuation phases (8 and 24     weeks, respectively).   "
77727|NCT02268474|"     A single center prospective, randomized, controlled split face study comparing a 532nm KTP     laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and     Papulopustular Rosacea.      Subjects will receive up to 3 laser treatments 4 weeks apart and will be followed at 4 to 6     weeks post-final laser treatment.   "
77768|NCT02267928|"     Prevention and early detection of medical problems can greatly reduce health care costs, yet     time and again, people avoid or ignore services that could help detect medical problems early     enough to prevent or reduce the severity of potential problems. The investigators seek to     understand whether the elicitation of symptom admission by patients can predict people's     perceived risk of the medical condition and voluntary pursuit of medical information.   "
77728|NCT02268461|"     Spasticity is a common complication of stroke affecting quality of life. Spasticity involves     exaggerated stretch reflexes that create stiffness in muscles with associated loss of motion     and functional control. Traditional treatments involve range of motion, medications, and     sometimes surgery. Each of these has its own limitations, which has invited exploration of     alternative modes of treatment. One such treatment with the potential to benefit spasticity     is repetitive Transcranial Magnetic Stimulation (rTMS).      The purpose of this study is to determine whether patients with upper limb spasticity as a     consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere     of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation     (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper     limb function.   "
77729|NCT02268448|"     The purpose of this study is to assess the safety and efficacy of oral clonidine in subjects     with symptomatic atopic dermatitis and to assess the safety and efficacy of oral naltrexone     in subjects with symptomatic atopic dermatitis.   "
77730|NCT02268435|"     The objective of this study is to determine the recommended dose of combination of dovitinib     and imatinib in phase I study.   "
77731|NCT02268422|"     To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st     generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of     drug) and that they equally both stick to the skin over 7 days of continuous wear.   "
77732|NCT02268409|"     Study A536-06 is an open-label extension study for patients previously enrolled in study     A536-04 (ClinicalTrials.gov Identifier NCT01749540), to evaluate the long-term safety and     tolerability of ACE-536 in adult patients with beta-thalassemia.   "
77733|NCT02268396|"     This is an open-label, multi-center study to evaluate the accuracy, reliability and     functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI)     dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment     Period.   "
77734|NCT02268383|"     Study A536-05 is an open-label extension study for patients previously enrolled in study     A536-03 (ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and     tolerability of ACE-536 in patients with low or intermediate-1 risk MDS.   "
77735|NCT02268370|"     The purpose of this study is to find out how to increase the potential for achieving an     operational cure from chronic myeloid leukemia. An operational cure is a state in which a     person does not require further treatment, although there may be some remaining cancer cells.     Patients would normally remain on a TK inhibitor indefinitely within a standard of care     setting for chronic myeloid leukemia. Within this clinical trial, patients will discontinue     their TK inhibitor prematurely. If any signs of progression are identified, dasatinib will be     introduced.      This research is being done because dasatinib has been shown to achieve a greater response in     a much higher proportion of patients as compared to imatinib. Dasatinib is approximately 300     times more potent than imatinib, and it is possible that a greater response can be achieved     by dasatinib than by imatinib.   "
77736|NCT02268357|"     Randomized, placebo-controlled, double-blind, parallel group clinical trial evaluating the     anxiolytic effects of propranolol on fear of wisdom tooth removal. It is hypothesized that,     compared to placebo, perioperative oral propranolol reduces dental trait anxiety at 1 month     follow-up after wisdom tooth removal.   "
77782|NCT02267746|"     The purpose of this study is to compare the safety and therapeutic equivalence of a generic     tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the     treatment of acne vulgaris.   "
77737|NCT02268344|"     Introduction: Shoulder pain and dysfunction is common after oncologic neck dissection for     head and neck cancer (HNC). These symptoms can hinder postoperative rehabilitation and oral     hygiene, activities of daily living (ADLs), and return to work after treatment. Due to the     rising incidence of Human papillomavirus (HPV)-associated oropharyngeal cancer, patients are     often diagnosed in the 3rd or 4th decade of life, leaving many potential working years lost.     Brief electrical stimulation (BES) is a novel technique that has been shown to enhance     neuronal regeneration after injury through a brain-derived neurotrophic growth factor     (BDNF)-driven molecular pathway. The aim of this study is to examine the utility of     intraoperative BES in prevention of shoulder pain and dysfunction after oncologic neck     dissection.      Methods: All adult patients with a new diagnosis of HNC undergoing surgery with neck     dissection including Level IIb and postoperative radiotherapy will be enrolled. Patients will     undergo intraoperative BES after completion of neck dissection for 60 minutes continuously at     20 Hz with an intensity of 1.5 times the motor threshold. Postoperatively, patients will be     evaluated using the Constant-Murley Shoulder Score, a scale that assesses shoulder pain,     activities of daily living (ADLs), strength, and range of motion. Secondary outcomes measured     will include scores on the Oxford Shoulder Score, the Neck Dissection Impairment Index     (NDII), and the University of Washington Quality of Life (UW-QOL) score. Primary and     secondary outcomes will be assessed at 1, 2, 3, 6, and 12 months postoperatively. Study and     placebo groups will be compared using a Mann-Whitney analysis.   "
77738|NCT02268331|"     This cluster randomized trial will be the first to specifically evaluate passive versus     active surveillance methods collection of adverse events (AEs). The evaluation of these     methods will be performed within the chiropractic healthcare profession, specifically among     those who treat children. To date there is no mandatory reporting and learning as part of     their profession. In Europe, a passive (voluntary) reporting and learning online system     (CPiRLS) has been created and will be utilized in this study for the passive reporting and     learning arm.      Manual therapy is the most common intervention provided by the chiropractic profession and is     the most commonly sought provider-administrated complementary and alternative therapy in the     United States pediatric population. This study will randomize participating doctors of     chiropractic who often treat children, to of one of two arms (active vs. passive reporting     and learning) to evaluate the quantity and quality of AE data collected.   "
77739|NCT02268318|"     INVESTIGATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT     STEROLS-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH     HIGH LDL-C.   "
77770|NCT02267902|"     The objectives of this study are to evaluate the absolute bioavailability, and absorption and     excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and     IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.   "
77740|NCT02268305|"     The investigators are studying whether MSM plus standard of care naproxen improves symptoms     of lower back pain compared to standard of care naproxen plus placebo. Subjects will be     randomized into 1 of 2 groups. Group 1 will take by mouth 6000 milligrams (mgs) of MSM plus     standard of care naproxen. Group 2 will take by mouth placebo capsules plus standard of care     naproxen. Subjects will be instructed to take their study pills for 12 weeks and record on a     study diary. They will then be followed up for one final visit 4 weeks later. RMDQ, PIQ-6,     pain level, comprehensive metabolic panel (CMP), complete blood count (CBC) will be assessed     at 4 week intervals for 12 weeks. Subjects' participation will last 16 weeks.   "
77741|NCT02268292|"     The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program.     All participators underwent an indoor bicycle exercise for twelve weeks. In addition to     demographic data and biochemical tests were determined after an overnight fasting. Extension     of muscle strength was detected in the dominant lower extremity.   "
77742|NCT02268279|"     Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and     intravenous) in children ages 0 to 17   "
77743|NCT02268266|"     Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of     vital parameters. The device is already CE marked and, for the purposes of the study, will be     used in accordance with the intended use (after-market clinical investigation).   "
77744|NCT02268253|"     This is a non-randomized open label multi-center study. Patients with high-risk     myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic     hypereosinoophic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia     [CMML]) will be treated with SL-401, which will be administered as a brief intravenous     infusion for 3 consecutive days initially every 21 days for 4 cycles; every 28 days for     cycles 5-7; then every 42 days. Stage 1 will consist of a period in which several doses of     SL-401 are evaluated. The Stage 2 portion will enroll up to 18 patients with each of the 2     myeloproliferative malignancies: MF and CMML. In entirety, the Stage 2 portion will consist     of up to 36 patients who will be treated at a maximum tolerated dose or maximum tested dose     in which multiple dose-limiting toxicities are not observed (identified in Stage 1).   "
77745|NCT02268240|"     The proposed study is a pilot randomized trial of a stepped collaborative care intervention     designed to decrease post-concussive symptoms and improve post-injury functioning among     sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms     (symptoms persisting at least two months post-injury) will be recruited from Seattle     Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and     assent will be obtained in-person. Participants will be randomized to receive either the     stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed     on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3     months, and 6 months after enrollment. The primary hypothesis is that the intervention group     athletes, when compared to usual care control group athletes, will demonstrate clinically and     statistically significant reductions in postconcussive, anxiety, and depressive symptoms over     the course of the 6-month study. Secondary analyses will assess the impact of the     intervention on functional impairment including missed school days and other academic     outcomes. Exploratory analyses will examine MRI findings that are characteristic of     postconcussive neuropathology, if available in medical record, as predictors of treatment     responses.   "
77746|NCT02268214|"     The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and     effective therapy to improve glycemic control in patients with type 1 diabetes.   "
77747|NCT02268201|"     KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of     the investigator would benefit from switch to a tacrolimus-based immunosuppression, will     switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of     patients will be observed for 52 weeks.   "
77750|NCT02268162|"     This study evaluates the value of different bronchoscopy combination for diagnosing     peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive     routine bronchoscopy, while one-third of participants will receive bronchoscopy combined with     a guiding equipment and the other one-third of participants will receive bronchoscopy     combined with two or more guiding equipments. These guiding equipments include virtual     bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and     fluoroscopy.   "
77751|NCT02268149|"     Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a     single dose of prednisone   "
77752|NCT02268136|"     The objective ot the present study is to obtain information about safety, tolerability and     preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of     increasing doses in healthy male volunteers.   "
77753|NCT02268123|"     The purpose of this study is to determine if sperm DNA fragmentation is associated with in     vitro fertilization (IVF) outcomes when euploid embryos are transferred.   "
77754|NCT02268110|"     The purpose of this study is to determine the effect of two different physiotherapeutic     interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of     diastasis recti in post-partum women.   "
77755|NCT02268097|"     The aim of this prospective, randomized study was to compare the clinical and radiological     results of free-hand technique and resection guide technique for preparing patella during     total knee arthroplasty.   "
77756|NCT02268084|"     The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in     treating Post Traumatic Stress Disorder in Veterans.   "
77757|NCT02268071|"     The STOP-Trial is a prospective multicenter nonrandomized open study on grade I hypertension,     performed by General Practitioners.      The main purpose of the study is to determine the factors associated with the rate of     patients remaining normotensive one year after stopping their antihypertensive monotherapy or     low dose dual therapy:        -  white coat hypertension        -  primary diagnosis by home blood pressure measurements (HBPM) /ambulatory blood pressure          measurements (ABPM) /clinical measure        -  initial blood pressure level        -  compliance        -  therapeutic class versus others        -  age        -  gender        -  weight variation        -  modification of lifestyle        -  concomitant treatments and associated substances      The primary endpoint will be the rate of normotensive patients at one year (i.e. HBPM values     <135/85 mmHg).   "
77758|NCT02268058|"     Concussions and headache are a significant problem for children and athletes. While headache     generally resolves within 7-10 days; a significant proportion of children, 72-93% experience     prolonged headache as a symptom of Post Concussion Syndrome (PCS). The prevailing clinical     view is that mild head injuries resolve with little chance of complications. However, the     reality is quite different. Concussion in children presents with a range of severity and     results in both short and long-term physical, cognitive, emotional and behavioural sequelae     known as PCS with varying times to resolution. To date there are no specific treatments for     headache pain related to concussion. Physical and cognitive rest is the mainstay of initial     concussion management.      The number of children presenting to ED's with a history of concussion and headache is     increasing. Presently there are no evidence based guidelines available to guide the medical     team to effectively and consistently manage their headache. Our present standard of care is     based on the CANCHILD concussion guidelines outlining the child's return to school and     activity. Yet, our present standard of treatment is compromised and somewhat     counterproductive if we are not treating the child's headache pain.      Our pilot study ' An Open Label Randomized Control Pilot Study Examining Treatment of     Headache In The Post-Concussive Youth' showed that routine administration of oral analgesia     improves the child's headache symptoms and helps with school re-entry one week post injury,     compared to a standard care group defined as non routine administration of pain medications.   "
77759|NCT02268045|"     Study of RTXM83 plus CHOP chemotherapy versus a rituximab plus CHOP therapy in patients with     Non Hodgkin's lymphoma The primary endpoint of the investigation is to determine if the     response rate obtained with RXM83 combined with CHOP is non inferior to the response rate     obtained with reference rituximab combined with CHOP The present study is a non inferiority     trial and the study hypothesis is the following: H0: pc ≥ pe + δ vs. H1: pc < pe + δ where,     pe: proportion of successes in the experimental group (RTXM83+CHOP) pc: proportion of     successes in the control group (Reference Rituximab+CHOP) Type I error: the difference pc-pe     is less than δ when in fact the difference is greater than or equal to δ ie, the     investigators choose the experimental treatment when the control treatment is actually     substantially better.      Type II error: the difference -pe is greater than or equal to δ when it is actually lest than     δ ie, the investigators choose the control treatment when the experimental treatment is     essentially just as good.   "
77760|NCT02268032|"     Evaluate the effect of continuous administration of DHEA or other androgenic agents on     ovarian reserve markers in women with diminished ovarian reserve (ROD), such as antral     follicle count and AMH concentrations.   "
77761|NCT02268019|"     A comparison between the two hemostatic methods of hypospadias repairing operation, in terms     of early and mid-term (up to 6 months) failure rate (wound dehiscence and urethral stricture     needing reoperation) between the two groups: Group A) diluted Epinephrine injection, Group B)     tourniquet application in children   "
77779|NCT02267785|"     The aim of this application is to compare and elucidate the effects of skill-based versus     aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function     (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will     result in the greatest improvement in EF and lead to modification of underlying neural     substrates.   "
77780|NCT02267772|"     Purpose: To determine if IV acetaminophen can 1) decrease pain in pregnancy women, 2)reduce     the amount of opioid use in pregnant women who encounter pain, 3) reduce maternal and fetal     adverse effects compared to opioids.      Design: This is a comparative effective trial that is a randomized, controlled trial of IV     acetaminophen vs. IV morphine in pregnant women.      Procedures: Women meeting inclusion/exclusion criteria will be randomized to IV acetaminophen     or IV morphine. The IV acetaminophen group will get up to four standard doses of IV     acetaminophen during their stay at the hospital. The second group will get up to six standard     doses of morphine. Subjects will complete a pain scale after medication administration and     will be asked about any side effects.   "
77762|NCT02268006|"     RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated     radiation therapy) allows shaping the dose around planning target volume with better sparing     of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher     dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total     treatment time with potentially better response to treatment. In advanced rectal     adenocarcinoma excellent response to preoperative radiochemotherapy with complete eradication     of the primary tumor observed in the histopathological specimen (pathological complete     response, pCR) correlates with a favorable overall prognosis, so trying to achieve better     response to preoperative treatment with higher pCR seams feasible.      PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally     advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22     daily fractions concomitant with capecitabine results in an improved pCR rate from 9%     (Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging     rate, histopathological R0 resection rate, sphincter preservation rate, perioperative     surgical complication rate, local control, disease-free survival (DFS), overall survival     (OS), late toxicity and quality of life.   "
77763|NCT02267993|"     In this single-center, randomized, open-label, crossover, prospective clinical trial, a total     of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in     each group. Each subject is required to undergo two cycles of chemotherapy. At the treatment     cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy     is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions,     blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO     treatment are recorded during the study period.   "
77764|NCT02267980|"     The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as     an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery     times during electroconvulsive therapy (ECT) in patients with major depression.   "
77765|NCT02267967|"     a multicenter, open-label phase Ib study to determine the safety, tolerability and     preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine     tumors   "
79136|NCT02250027|"     The purpose of this study is to determine the optimal dose of HL301 in patients with acute     bronchitis or acute exacerbations of chronic bronchitis.      - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation     of symptoms of cough and sputum   "
77772|NCT02267876|"     The purpose of the study is to assess the cumulative disease detection of greater than or     equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical     intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV     status and cytology status from the BDS-USHPV baseline results   "
77773|NCT02267863|"     This is a phase 1b study to determine the maximum tolerated dose (MTD), dose limiting     toxicity (DLT) and recommended phase 2 dose of APTO-253 HCl in patients with relapsed or     refractory hematologic malignancies.   "
77774|NCT02267850|"     The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light     Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a     double-blinded RCT with half the patients receiving treatment from a sham non-functional     device, serving as controls, and the other half receiving light therapy treatment from a     functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared     to that of the OrthoPulse™ patients.   "
77775|NCT02267837|"     The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light     Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.   "
77776|NCT02267824|"     The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED     (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete     orthodontic alignment.   "
77777|NCT02267811|"     The purpose of this investigation is to evaluate the clinical effectiveness of the     OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, and for     investigators to evaluate the product in a clinical setting.   "
77778|NCT02267798|"     Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The     relationship between intensity of rehabilitation and clinical outcomes, recently emphasized,     has generated a great interest for technological high-intensity interventions. However, their     effects compared to traditional interventions as well the involved biological mechanisms     remain uncertain. The present Strategic Program aims to predict the treatment efficacy in     specific rehabilitation profiles, to improve the use of targeted therapies and the     individual management of patients affected by stroke and to transfer these findings into     rehabilitative strategies.   "
77787|NCT02267681|"     This study aims to compare the effects of fentanyl and alfentanil on postprocedural cognitive     function in elective endoscopy.      150 patients will be enrolled in the study. Patients meeting eligibility criteria will be     randomly allocated to three groups.      The patients in Group A will be given propofol and alfentanil. The patients in Group F will     be given propofol and fentanyl. Group P is designated as the control group and the patients     will be given propofol for sedation.      Awareness, vital signs and pain will be evaluated. Side effects will be recorded. Patient and     endoscopist satisfaction will be evaluated.   "
77788|NCT02267668|"     The study will monitor outcomes of two interventions to develop a best practice in the     treatment of mild Traumatic Brain Injury (mTBI).   "
77789|NCT02267655|"     The objective of this exploratory study is to examine the utility of high resolution computed     tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function     of short term a) iNO administration and b) nitric oxide (NO) cylinder concentration using the     investigational medical device INOpulse® DS-C in subjects with WHO Group 3 PH associated with     COPD on LTOT (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic     Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)   "
77790|NCT02267642|"     To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered     intravenously in patients with active psoriatic arthritis.   "
77791|NCT02267629|"     This research study tests whether GLYX-13 - an experimental drug that acts on a brain     receptor called NMDA - can decrease symptoms of OCD within hours. This is not a treatment     study. Results from this study will allow doctors and researchers to better understand if you     and others with OCD may respond to a class of medications that target the NMDA brain     receptor.   "
77792|NCT02267616|"     This study will evaluate LNG-IUD and ENG implant users who are willing to use their     contraception beyond the end of the FDA-approved duration. Implant users will also be offered     to participate in an arm of the study that will randomize them to either keeping their     implant in or have it removed and replaced with a new implant. Participants will be followed     for up to three years.   "
77794|NCT02267590|"     Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in     Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.   "
77795|NCT02267577|"     The research team has developed an automatic blood pressure monitor to be used for the     monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource     settings where current monitoring is limited.      90 adult volunteers will be enrolled by researchers at Rice University. The participant will     be seated in a comfortable chair with arm at heart level. Arm circumference will be measured     and a blood pressure cuff will be placed on the arm. The cuff will be inflated and blood     pressure measurements will be taken by a commercially available device and by test monitor.     Blood pressure measurements from both devices will be recorded. The participant's blood     pressure will be measured up to 9 times with a waiting period of 45-60 seconds between each     measurement.      The results of this study will be used to optimize the blood pressure detection algorithm and     thus further develop the device.   "
77796|NCT02267564|"     This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL)     reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.   "
77797|NCT02267551|"     The objective of this study is to determine whether a group of resident physicians otherwise     naïve to robotic surgery can demonstrate equal levels of proficiency during their first     robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer     or the daVinci Skills Simulator.   "
77952|NCT02265523|"     The purpose of this investigation is to examine the effect of, and improve patient compliance     and motivation following total knee arthroplasty; to determine the efficacy of two     post-surgical exercise programs on knee pain, function, range of motion, strength, and     swelling (girth); and to establish a panel of biomarkers that will allow: a) early     identification of patients at risk (i.e. unable to complete post-operative treatment) and; b)     predict the likelihood of a successful treatment outcome post-surgically.   "
77798|NCT02267538|"     Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery.     Its occurrence is associated with worse outcomes of patients, including increased morbidity,     prolonged hospital stay, increased medical cost, and higher mortality. It is also associated     with long-term cognitive decline and decreased quality of life. However, until recently,     pharmacological interventions that can effectively prevent its occurrence are still limited.     The purpose of this study is to investigate whether perioperative dexmedetomidine use can     decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.   "
77799|NCT02267525|"     Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment     of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of     velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy.     In addition, the study will be used to evaluate the psychometric properties of the     Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.   "
77800|NCT02267512|"     To investigate the efficacy and safety of ATG-F induction regimen using a single dose of     ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.   "
77801|NCT02267499|"     The study involved Information and Communication Technologies (ICT) and more specifically     computer exercises blended with game activities. It was hypothesized that ICT facilitated,     game blended combined cognitive and physical exercise improves global cognition when compared     to a control group; and that the number of sessions within exercising participants predict     cognitive benefits. In addition, we explored the impact of potential moderators on combined     exercise-induced cognitive benefits.   "
77802|NCT02267486|"     Examine the construct validity, the group discriminant ability, and the inter-rater     reliability of a novel dementia rating scale (QuQu scale: QUick QUestion scale) candidate for     the evaluation of patients with Alzheimer Dementia (AD)   "
77803|NCT02267473|"     Patients with chronic Hepatitis B who are under oral antiviral treatment for at least 6     months at study start will be monitored once yearly for kidney function changes within their     routine outpatient visit. Therefore urine samples will be collected and some additional blood     test will be done within the routine blood sampling.   "
77882|NCT02266446|"     The purpose of the study is to develop a personalized, user-friendly computerized treatment     for anxiety disorders linked to primary care. The computerized treatment is a type of     Cognitive Bias Modification, which targets attention and interpretation biases known to     maintain anxiety disorders.   "
77804|NCT02267460|"     Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by     degree of penile curvature and then randomized in a 1:1 ratio to one of the following     treatment groups:        -  AA4500 with investigator modeling        -  AA4500 without investigator modeling      Each subject will receive 2 injections of AA4500, separated by approximately 24 hours to 72     hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles.      Approximately 14 days after the second injection of AA4500, each subject will visit the study     site and the investigator will assess the subject and instruct the subject on appropriate use     of the ErecAid® Esteem® Manual Vacuum Therapy System.   "
77805|NCT02267447|"     The purpose of this study is to develop, evaluate, and apply a predictive algorithm for     assessing CVD risk in the community setting: the Cardiovascular Disease Population Risk Tool     (CVDPoRT).   "
77806|NCT02267434|"     Study AFF011 is a randomized controlled parallel Group phase I study to investigate the     safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with     early Parkinson's disease.      In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo     group), each consisting of 12 patients. The patients will be randomized to either receive     15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without     active component (Placebo). Over a study duration of 52 weeks, the study participants receive     4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks     after the first injection. Male and female patients aged 45 to 70 years can participate in     the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved.      AFF011 is part of a project SYMPATH funded by the European Commission     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).   "
77807|NCT02267421|"     Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised     exercise training has been shown to be an effective intervention to remedy this, there is     currently no data on home based exercise interventions in this population. This study will     evaluate the effects of a home based exercise program on the aerobic capacity of enrolled     early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle     thickness, and thigh muscle oxygen consumption.   "
77808|NCT02267408|"     Patients on warfarin but with unstable international normalized ratio (INR) will be recruited     to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after     the mathematician Michael Fearon), which uses historical data to estimate patients'     sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment     takes effect, or to the investigators standard management Main outcome is improvement in time     in therapeutic range.   "
77809|NCT02267395|"     The study will investigate if there are differences in the presence of: (1) prior injury,     playing patterns, and physical fitness habits; (2) scapular control; and (3) cervical     neuromuscular control and endurance deficits between musicians with and without current     playing related musculoskeletal injuries.   "
77810|NCT02267382|"     VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in     vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida     albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161     is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect     profile that limits the use of commonly prescribed antifungal agents for the treatment of     recurrent yeast infections.   "
77953|NCT02265510|"     This is a study of INCB052793 given to patients with advanced malignancies that will be     conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and     Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine).     Phase 1 will have two parts; a dose escalation (Part 1) and an expansion (Part 2).   "
77811|NCT02267369|"     The overall objective of this research is to collect data for understanding whether messages     in online environments impact fitness attitudes and behaviors. In particular, the study aims     to experimentally examine what features of online social media - promotional messaging or     peer networks - impact offline fitness measures (such fitness workshop enrollment and     self-reported physical activity level). The study partners with an existing fitness program     at a large northeastern university, which provides a 13-week fitness program for graduate and     professional students at the university. The program begins with a university-run eligibility     assessment of specific fitness measures for all participants, who win prizes for improvements     in program participation and health behavior outcomes. The fitness program consists of     semester-long series of workshops offered through the university's recreation department. The     randomized trial constructs an online social media platform for the fitness program that     provides a way to send either promotion health messages or messages about peer activities to     the online community.   "
77812|NCT02267356|"     VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in     vivo pharmacology studies have demonstrated that VT-1161 is highly active against     dermatophytes that cause onychomycosis . VT-1161 is highly selective for fungal CYP51, and     data suggests that it may avoid the side-effect profile that limits the use of commonly     prescribed antifungal agents for the treatment of onychomycosis.   "
77813|NCT02267343|"     The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with     unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)     refractory to or intolerant of standard therapy.   "
77814|NCT02267330|"     The aim of this cohort study is to precisely measure patients' exposure to gonadal radiation     during orthopaedic trauma surgery involving the acetabulum, pelvis, hip, and femur, and to     apply these findings to a previously described and validated formula to determine the     increased risk of future adverse health effects to the reproductive organs.      The investigators null hypothesis is standard of care use of x-ray fluoroscopy during     treatment of pelvis, hip, and femur fractures will not expose patients to a significant     gonadal radiation load. Analysis of patients' intraoperative radiation doses by means of a     previously validated formula will not display a significantly increased risk of adverse     health events in the reproductive organs.   "
77815|NCT02267317|"     To determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran     for injection (E5564) will reduce inflammation and improve glucose metabolism in insulin     resistant (obese and T2DM) subjects.   "
77864|NCT02266680|"     The goal of this study is to determine the safety and effectiveness of Breathing Focused Yoga     (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be     randomized to 8 weeks of yoga or 8 weeks of wait-list. Symptom severity and quality of life     will be compared between the two groups before and after the 8 weeks.   "
77816|NCT02267304|"     The aim of the current study is to examine the role of the opioïd system on the cognitive     parameters of motivation. They are embedded in a conceptual framework of motivation that     merges decision-making and reinforcement learning theories. Every action is conceived as path     from one state to another. The different states are associated to different values (positive     for rewards and negative for punishments), and the different actions to different costs     (risk, effort and delay). The tasks are designed such that the sensitivity to the state and     action parameters can be inferred by fitting computational models.The primary objective is to     characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on cost accumulation slope,     assessed in an effort management task, in which participants are asked to squeeze a hand grip     during 30 seconds at varying level of effort in order to win monetary payoff. Secondary     objectives are to characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on other     cognitive parameters of motivation (assessed with a motivational battery that includes     rating, choice and learning tasks).   "
77817|NCT02267291|"     Cardiologists and intensive care specialists are confronted daily with mechanically     ventilated patients exhibiting cardiac failure. It is of paramount importance to understand     the effect of mechanical ventilation on cardiac function and to interpret echocardiographic     findings correctly in order to provide the patient with the best possible treatment to     support cardiac and circulatory function. Currently physicians interpret echocardiographic     findings based on studies that were performed in spontaneously breathing patients. With this     study, the investigators intend to contribute to the understanding of cardiac physiology in     patients needing ventilatory support, especially they aim to provide the physiological basis     for the interpretation of echocardiographic findings in order to improve medical support     (e.g. fluid resuscitation, vasoactive drugs, ventilation strategy) of ventilated patients     with impaired cardiovascular function.   "
77818|NCT02267278|"     The goal of this clinical research study is to learn if pracinostat, when given in     combination with ruxolitinib, can help to control MF. The safety of this drug combination     will also be studied.   "
77832|NCT02267096|"     In 2011, the National Lung Screening Trial (NLST) reported that lung cancer mortality was     reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. It is estimated     that 8 million people in the US are at high risk for lung cancer and that lung screening     could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent     smoking cessation programs will be essential in order to realize the full benefit of     screening. However, there are no clinical guidelines or evidence-based cessation protocols     with demonstrated effectiveness in this setting. The investigators are addressing this gap by     rigorously testing whether two scalable and pragmatic interventions can significantly boost     intention to quit and cessation rates.   "
77833|NCT02267083|"     This study will assess the safety and efficacy of GPX-150 administered intravenously every 3     weeks in the treatment of patients with soft tissue sarcoma.   "
77966|NCT02265341|"     This pilot phase II trial studies how well ponatinib hydrochloride works in treating patients     with biliary cancer that has spread to other places in the body and that have alterations     (fusions) in a gene known as fibroblast growth factor receptor 2 (FGFR2). Ponatinib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
79152|NCT02249819|"     The purpose of this study is to determine if non-invasive brain stimulation (transcranial     direct current stimulation) delivered prior to language therapy will improve word-finding in     individuals with aphasia who are 6 months or greater post-stroke.   "
77819|NCT02267265|"     A child's early language environment is pivotal for language development. Disparities in     early language environments contribute to the gap in school readiness between poor and more     advantaged children. Ultimately this leads to disparities in students' school achievement and     economic outcomes. While recent research has highlighted the value of early intervention for     children in disadvantaged families, most existing interventions begin too late, reach only a     small proportion of children at risk, and do not capitalize on the critical role that parent     language plays in a child's educational trajectory. To address this challenge, the     investigators propose to develop and evaluate a novel language-based, perinatal public health     intervention, Thirty Million Words Newborn Initiative (TMW-NI). It is proposed that new     mothers will receive this educational intervention while their babies are undergoing the     universal newborn hearing screen. The intervention will use video, animation, and interactive     questions to convey the importance of the early language environment and to illustrate     strategies parents can use to promote language learning. The investigators will conduct     formative research with mothers of low socioeconomic status (low-SES) and with healthcare     providers to inform the content and format of the intervention prototype. Also critical for     acceptability, the investigators will use an iterative approach to develop the intervention,     with review of the work-in-progress by the intended audience. To assess feasibility and     initial efficacy, the investigators will conduct a randomized-controlled trial with low-SES     mothers during the newborn period. The investigators hypothesize that TMW-NI will positively     impact parents' knowledge and beliefs about the role of language input for a child's language     development.   "
77820|NCT02267252|"     Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa     as a possible explanation of the lower sex ratio observed after microinsemination using     epididymal sperm from vasectomized men.   "
77821|NCT02267239|"     The study has the objective to compare two different methodology of application the     antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The     first one using the immersion in the antiseptic solution, as much of the authors did in the     past. And the second way doing a active mouthwash, as the manufacturer recommends.      The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine     Perio) and the essential oils (Listerine Mentol) with the two different application and     compared the bacterial vitality, thickness and covering grade between solutions and with a     basal sample.   "
77822|NCT02267226|"     The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand     treatment of acute bleeding in subjects with congenital fibrinogen deficiency.   "
77823|NCT02267213|"     The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a     second line treatment in subjects with advanced Hepatocellular Carcinoma.   "
77824|NCT02267200|"     The purpose of this study is to analyse the sensitivity and specificity of circulating     endothelial cells to predict irreversible pulmonary arterial hypertension associated with     congenital heart disease.   "
77825|NCT02267187|"     This study will examine the impact of the fat grafting procedure on facial appearance and     quality of life over time by precisely measuring soft tissue volume with CT scans, assessing     appearance with 2D and 3D photography and standard photography and evaluating quality of life     through various validated psychosocial measures. This study will be a very important     evaluation of the effectiveness of this therapy, and will help guide clinicians in applying     this technique. Additionally, laboratory testing of the injected fat material will be     performed so that the results may be correlated with clinical outcomes in the future.      The study endpoints include the analysis of the graft site via study procedures at different     time points, the comparison of cotton rolling to centrifugation method of autologous fat     grafting, as well as the correlation of cell behavior of the laboratory assays with clinical     outcomes.   "
77826|NCT02267174|"     The HATRICC study will use mixed methods to implement a standardized process for operating     room to intensive care unit handoffs that is accepted and sustainably used by perioperative     clinicians.   "
77827|NCT02267161|"     The purpose of this study is to assess the neurological development at three years of age of     children born after prenatal diagnosis of isolated agenesis of the corpus callosum.   "
77828|NCT02267148|"     Non-alcoholic fatty liver disease (NAFLD) is a common disorder, affecting ~30% of people in     the general population and up to 96% of obese individuals. Variations in several genes have     been found to be associated with fatty liver, but these associations only explain a small     percentage of the risk, and further studies are needed. In many cases NAFLD does not cause     serious side effects, but in some individuals it progresses to scarring or hardening of the     liver, liver failure, and cancer.      The purpose of this research study is to determine if individuals who carry certain genetic     variations in a gene related to bile and choline metabolism have an increased risk of fatty     liver progressing to fibrosis, or scarring of the liver. This study will also use a new,     non-invasive method called the FibroScan® to measure liver fat and liver stiffness. The     FibroScan® device is FDA approved for use to measure liver stiffness, but not for the liver     fat measurement. However, the FibroScan® instrument is considered a non-significant risk     device. Since its induction in Europe and worldwide in 2003, there have been no adverse     effects reported with this device.   "
77829|NCT02267135|"     This study will assess the efficacy and safety of secukinumab compared to placebo in adult     patients who have moderate to severe scalp psoriasis that is poorly controlled by current     psoriasis treatments.   "
77830|NCT02267122|"     The patients were randomized into 3 groups: those patients undergoing a ionic     silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application     (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after     finishing an elective colorectal surgery.   "
77831|NCT02267109|"     Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the     largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is     impossible for someone to get an Ebola infection from this vaccine.   "
77855|NCT02266797|"     This is a randomized, double-blind, placebo-controlled study to examine the effect of local     intravenous steroids following anterior cervical spine surgery on the development of     dysphagia in patients.   "
77834|NCT02267070|"     This is a randomized controlled 6-month trial of the efficacy of a novel intervention     combining neuroplasticity-based cognitive training with aerobic exercise, compared to the     same systematic cognitive training alone. The primary treatment targets are overall cognitive     deficit level and independent living skills. The investigators hypothesize that combining     neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical     exercise will produce large cognitive and functional improvements, even relative to cognitive     training alone. Adding aerobic exercise to a cognitive training program will have the     additional benefit of helping to ameliorate medication side effects, reduce the risk for     developing metabolic syndrome, and help to prevent the deterioration in physical health that     usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators     target the period shortly after a first episode of schizophrenia to maximize the     generalization of cognitive improvement to functional outcome, before chronic disability is     established.   "
77835|NCT02267057|"     The purpose of this study is to determine whether pain treatment can reduce symptoms of     depression in patients suffering from dementia and depression. Depression is commonly     diagnosed in patients with dementia. If the investigators find a reduction in depressive     symptoms when pain treatment is applied, this will support the hypothesis that undiagnosed     pain may present itself as depression in patients with dementia.   "
77836|NCT02267044|"     Shoulder replacement surgery is recognized as having the potential to cause a considerable     amount of postoperative pain. Adequate management of pain after surgery is necessary not only     to improve the patient's wellbeing but also to facilitate recovery. Several regional     anesthesia techniques are available to combat postoperative pain in the shoulder replacement     surgery patient, however, which method provides superior pain relief remains unknown. The     purpose of this study is to examine the effectiveness of a continuous interscalene block     versus a single shot interscalene block for postoperative pain relief in the shoulder     replacement patient.      Patients undergoing shoulder replacement surgery will experience more effective pain relief     with a continuous interscalene block versus and single shot interscalene block.   "
77837|NCT02267031|"     Abdominal surgery commonly requires perioperative relaxation and therefore controlled     mechanical ventilation. However, respiratory support can be associated with minor, yet     clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively     high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient     changes in cerebral blood flow and cognitive impair.   "
77838|NCT02267018|"     Preterm babies have immature lungs and frequent pauses in their breathing which often     necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of     the most commonly used tools, but does not always provide enough support. A new option is     non-invasive high frequency ventilation (NIHFV), which gently shakes the lungs to help with     gas exchange and may decrease a baby's work of breathing. The investigators plan to study     very low birth weight preterm babies who are generally well but require some support with     their breathing. By inserting a special feeding tube with sensors into the stomach, the     investigators can measure the electrical activity of the diaphragm (EAdi), which is an     important muscle for breathing. By analyzing EAdi in babies receiving either nCPAP or NIHFV,     the investigators will be able to measure and compare how each method of support affects a     baby's breathing. This important study will help us determine the most appropriate breathing     support for preterm babies.   "
77880|NCT02266472|"     The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose     combination (FDC) tablet containing empagliflozin and metformin extended release compared to     the free combination of empagliflozin and metformin extended release under fed conditions.   "
77839|NCT02267005|"     This project will bring together a multidisciplinary team of pediatric rheumatologists,     neurologists, metabolic geneticists and exercise physiologists to determine the effect of     creatine (CR) supplementation on muscle function and muscle metabolism in children with     Dermatomyositis (DM). The investigators propose using well-established exercise testing     techniques as well as new, powerful exercise imaging protocols in order to better delineate     the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study     will provide information regarding the effect of creatine supplementation on muscle function     in DM. Improvements in muscle function and fatigue through CR use may also contribute to an     improvement in quality of life and have significant clinical implications for the treatment     of children with DM.   "
77840|NCT02266992|"     Influenza ('flu) can cause severe infections, especially in people with weakened immune     systems such as those with HIV. For this reason, yearly vaccination is recommended with the     standard 'inactivated' influenza vaccine to try and prevent infections in these populations.     It is also recommended in all health care workers, to help prevent the spread of influenza     within healthcare settings. However, having HIV infection may mean vaccines work less well in     some people and the investigators do not completely understand why. An alternative to the     standard 'inactivated' annual influenza vaccine is the 'live attenuated influenza vaccine'     (LAIV), which means it consists of weakened versions of the influenza virus.      Unlike the standard vaccine, which is given by injection, LAIV is a spray that is given into     each nostril. It is now given to children in the UK in preference to the standard vaccine as     it results in greater protection from influenza. In some other countries, like the USA,     adults are also given LAIV, where it seems to work just as well as the standard vaccine. A     few studies in the past have shown that LAIV is safe and effective in HIVinfected children     and adults. The investigators want to give LAIV to HIVinfected and HIV negative individuals,     to try to find out new information about how HIV infection may change the way in which people     respond to vaccines. The investigators will do this by comparing both the early genetic     response to the vaccines and later responses from cells specifically targeted to fight     influenza ('Tcells'), in these groups. In the long term, the investigators hope that this     will lead to designing new ways of improving the response to vaccines in HIVinfected people.     As LAIV is given into each nostril, rather than an injection, the investigators also want to     see if LAIV results in Tcells in the lung that are specifically targeted to fight influenza   "
77903|NCT02266173|"     This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing     surveillance) will evaluate the safety of pertuzumab in approximately 3000 participants with     metastatic or locally unresectable recurrent breast cancer who have never received     chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their     metastatic disease with HER2 positivity in Korea. Participants who are administered with     pertuzumab according to medical opinions of the doctor in charge of surveillance will be     registered for this study and treated with pertuzumab under the approval conditions of the     product in Korea.   "
77904|NCT02266160|"     The investigators like to learn whether EMLA cream 5% helps tinnitus patients. so far it is     known that lidocaine I.V do helps tinnitus but until now it is not clear if topical     anaesthetics (e.g EMLA cream) helps tinnitus.      The investigators are going to compare 4 days of treatment of EMLA 5% cream Versus (VS.)     cetomacrogol cream (water- based lotion cream) in treating tinnitus patients.   "
77841|NCT02266979|"     As the resolution of the Brazilian Federal Council of Nursing (COFEN) sizing the framework of     nursing professionals is essential to ensure the safety and quality of patient care. To     achieve such goals actions are needed to evaluate the variety of tasks and performance     specific to each area in nursing profession. The National Agency for Health Surveillance     (ANVISA), through Board Resolution (RDC-154) determines that the nurse to patient ratio is 1     to 30 in hemodialysis and 1 to 50 on peritoneal dialysis, however these targets are not based     on any evidence, and same apply to other Latin-American countries. Objective: To determine     the appropriate nurse: patient ratio for peritoneal dialysis unit. Method: This research will     be developed in two phases. The first with an observational design with descriptive and     qualitative approach. There will be a focus group with experts in the field, to defined the     activities and responsibilities of the peritoneal dialysis nurse, and produce a tool with a     list of activities. A time-orientated score will be created. In the second stage a     cross-sectional quantitative approach will be used. To apply the instrument from by direct     observation of activities performed by nurses during their workday. With the instrument     activities will be timed and the overall time of each nursing activity will be determined by     multiplying the time spent by the total number of patients. It is expected tat this strategy     will increase time on treatment and/or decrease dropout rates, by developing an easy test/     formula application to determine the correct ratio according to the peritoneal dialysis     program. This tool will provide better outcomes for patients as well as allow for growth of     peritoneal dialysis programs with qualified assistance and patient safety.   "
77842|NCT02266966|"     The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of     single dose of F2695 at 75mg on modulation of the cerebral motor network.   "
77843|NCT02266953|"     The purpose of this study is to promote optimal nutrition for the child based on the public     health nurse's family-focused conversations at the child health centre. An image based     communication tool is used in an intervention in order to promote dialogue and active     participation by the parents about themes concerning food and feeding practices.   "
77844|NCT02266940|"     This is an open label, randomised, 3 treatment, 3 period crossover study. This study is     designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a     reconstituted oral suspension and the effect of a high fat meal on the relative     bioavailability of DS 1971a from the tablet formulation.   "
77845|NCT02266927|"     To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440     µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.   "
77846|NCT02266914|"     Magnetic Resonance Elastography (MRE) for cardiac transplant patients.   "
77847|NCT02266901|"     Patients presenting intra-abdominal abcesses following bariatric surgery complicated by     fistulae are classically treated by external drainage and endoprosthesis or surgical redo.     Morbidity and mortality being increased in case of necrotic collections, an endoscopic     debridement treatment might be proposed in certain cases. This present study aim to review     the evolution of the patients treated by this method from 2007 to 2011 in the investigators     institution.   "
77848|NCT02266888|"     In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will     lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells     with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has     been studied in other types of solid organ transplants.   "
77849|NCT02266875|"     A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline     (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale     scores after 4 treatments within 24 hours.   "
77850|NCT02266862|"     Purpose: The purpose of this study is to evaluate the location within the renal artery of     maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR)     using CT with end-inspiration and end-expiration CT images before and after repair. Then, the     renal artery segment with maximal angular displacement on each will be located and any     changes described.      Participants: There will be 30 subjects recruited from UNC Hospitals.      Procedures (methods): For this study, patients will receive an additional CT sequence     (end-expiration CT), which will be compared with the standard of care end-inspiration CT to     calculate angular displacement and the distance from the aorta.   "
77881|NCT02266459|"     This is a prospective, open, multicenter study that will enroll patients admitted to and     hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.      The main purpose of the study is to evaluate the ability of the Microwave Technology to     deliver adequate measurement data.   "
77851|NCT02266849|"     Clinical experience show limited effect of the drug Loperamide used to decrease output in     stoma patients. Therefore the investigators see the need for a randomized blinded clinical     trial to determine the effect of Loperamide opposite Placebo.      Loperamide will be evaluated in relation to the following parameters        -  Change in ileostomy output in g/day in relation to oral intake        -  Quantification of the change in intestinal transit time using a radiopaque marker        -  The patient´s own assessment on which period they received Loperamide or Placebo   "
77852|NCT02266836|"     The purpose of this study is to examine the efficacy of MyndMove therapy in the early     sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include     assessing the required doses of electrical current amplitudes, the usability of the device,     and examining the overall safety.   "
77853|NCT02266823|"     The purpose of this study is to pilot test an mHealth technology-supported behavioral     intervention designed to engage patients with diabetes and concurrent chronic kidney disease     (CKD) in multiple behaviors which aim to reduce CKD progression. Participants will be     randomized to the 6-month lifestyle intervention or to a wait-list control. The lifestyle     intervention will be modeled after that used in the Diabetes Prevention Program (DPP) and the     counseling intervention will be based on SCT, which will be paired with mobile     technology-based dietary and physical activity monitoring. The wait-list control will receive     6 months of standard medical care followed by a delayed, but less intensive, 6-month     intervention.   "
77854|NCT02266810|"     The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini     and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening     following frontal sinus surgery in patients with chronic sinusitis.   "
77856|NCT02266784|"     The overall goal of the study is to evaluate how motivation and readiness for change are     influenced in the context of a smoking cessation attempt. A total of 60 adult (i.e. age     18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be     enrolled into a 3-arm trial allocated as follows. Twenty of the ADHD smokers and the 20     non-ADHD smokers will be assigned to a traditional 8-week contingency management intervention     in which monetary payments will be made contingent upon biologically verified evidence of     smoking abstinence. The 20 additional ADHD smokers will be assigned to a treatment-as-usual     condition (nicotine replacement; supportive counseling). During the treatment phase, subjects     will be required to answer questions 4x/week in their daily lives via an EMA (Ecological     Momentary Assessment).      Specific Aim 1: To assess motivation to quit smoking and readiness for change prior to a quit     attempt in treatment seeking ADHD and non-ADHD smokers. Hypothesis 1a: The investigators     hypothesize that prior to a quit attempt, smokers with ADHD will exhibit significantly lower     levels of intrinsic motivation to quit, and equal or higher levels of extrinsic motivation to     quit compared to smokers without ADHD. Hypothesis 1b: The investigators hypothesize that     smokers with ADHD will exhibit relatively less readiness for change than smokers without     ADHD.      Specific Aim 2: To assess how baseline levels of motivation to quit and readiness for change     are influenced during a quit attempt as a function of both ADHD status and treatment     modality. Hypothesis 2a. The investigators hypothesize that the CM intervention will result     in relatively greater change in extrinsic motivation to quit versus intrinsic motivation to     quit, and that this effect will be more pronounced among ADHD smokers. Hypothesis 2b: The     investigators hypothesize that overall motivation to quit (intrinsic and extrinsic) and     readiness for change will be significantly influenced by the CM intervention versus treatment     as usual among ADHD smokers.      Exploratory Aim 1: To assess the relative efficacy of a CM intervention versus treatment as     usual in smokers with ADHD. The investigators hypothesize that CM will be more effective for     promoting short-term (4-8 weeks) smoking abstinence, as well as for promoting longer-term     (3-6 months) smoking cessation.      Exploratory Aim 2: To assess the associations among smoking withdrawal/craving, affect, ADHD     symptoms, and motivation to quit/readiness for change. The investigators hypothesize that     higher levels of motivation and readiness for change will be associated with lower levels of     self-reported withdrawal, craving, and negative affect.   "
77857|NCT02266771|"     The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative     pressure wound therapy with instillation, when compared to historical controls of V.A.C     Therapy without instillation in the management of wounds.   "
77858|NCT02266758|"     This project randomizes two different screening strategies for diabetes in pregnancy, among a     study population of over 17,500 pregnant women and their babies (over 35,000 total) in a     large diverse health maintenance organization (HMO), to determine how diagnosis and treatment     based on these two strategies in routine clinical care affects complications for the baby and     the mother.   "
77859|NCT02266745|"     This is a Phase I, open-label, multi-center, non-randomized, dose-escalation study to be     conducted in two parts: the Dose Escalation Phase and the Dose Confirmation Phase. The Dose     Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2     dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, PK     (pharmacokinetic) and preliminary clinical effects. The Dose Confirmation Phase will be a     cohort expansion at or below the MTD of PT-112 Injection. Subjects who tolerate the drug and     who do not experience progressive disease may continue to receive PT-112 Injection at the     discretion of the Principal Investigator for up to 6 cycles. For subjects who tolerate PT-112     Injection and who experience an objective response or stable disease through 6 cycles, the     Sponsor will continue to provide PT-112 Injection under a separate mechanism, e.g., an     extension protocol.   "
77860|NCT02266732|"     The traditional model of localizing a nerve for blockade is using a peripheral nerve     stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide     nerve blockade. However despite excellent visualization nerve block success has not     significantly improved. I aim to show that this is because the PNS stimulation of a nerve is     more than a proximity response as thought but a correct fascial plane response and hence the     high success rate of this blind approach.   "
77861|NCT02266719|"     This is an investigator sponsored Investigational Device Exemption (IDE) aimed to assess the     use of the Custom Made Device (CMD) to repair juxtarenal aneurysms, suprarenal and type IV     thoracoabdominal aneurysms in standard risk patients having appropriate anatomy. This study     is a prospective, single-center, non-randomized, single-arm study.   "
77862|NCT02266706|"     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a     single intravenous dose of ceftolozane/tazobactam in pediatric participants.      Ceftolozane/tazobactam is a novel antibacterial consisting of ceftolozane, a unique     antipseudomonal cephalosporin, with tazobactam, a well-established β-lactamase inhibitor.      This is the first study investigating the use of ceftolozane/tazobactam in pediatric     participants.   "
77863|NCT02266693|"     This 8-week, pilot randomized, controlled trial to evaluate the benefits of transdiagnostic     Internet-based CBT (iCBT) in young adults with MDD, SAD, PD or GAD. The investigators     hypothesize that patients who receive iCBT will show significant improvement in anxiety     symptoms and functioning, compared to a wait-list group. This pilot randomized controlled     study will assess the efficacy of transdiagnostic iCBT in 60 young adults.   "
81112|NCT02224248|"     The purpose of this study is to investigate if including fitness testing in preventive health     checks increase cardiorespiratory fitness and motivation to change physical activity behavior     compared with preventive health checks without fitness testing.   "
77865|NCT02266667|"     The purpose of this study is to evaluate the performance of the device NEMOST on     maintaining of the correction of the scoliosis with growth preservation and avoiding     iterative surgeries.      Objective of this study is to evaluate the performance of the growing device NEMOST     associated to physiotherapy at 12 months postoperatively in patients treated for progressive     scoliosis and to evaluate its safety.   "
77866|NCT02266654|"     The goal is to evaluate the best way for paramedics and hospitals to work together to treat     septic patients as quickly as possible.      The investigators think that the best thing to do for septic patients is to identify and     treat them as early as possible. This research will test this. The investigators think that     if paramedics identify septic patients and begin treatment with fluids in the ambulance, then     the patient will do better in the long run. The paramedic will also tell the hospital that a     septic patient will be there soon. The caregivers can prepare and be ready to provide care as     soon as the patient arrives. With this research, the investigators would like to see if these     steps help patient outcomes.   "
77906|NCT02266134|"     Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion     annually; however, Measurement Based Care (MBC) is a relatively simple evidence-based     intervention framework that has been shown to improve outcomes for depressed clients by     identifying those who are not making progress and reducing the likelihood that clients will     deteriorate in treatment. Despite the demonstrated effectiveness of MBC, the majority of     community mental health counselors do not regularly assess target problem symptoms to guide     their work. This study will test a standardized versus a tailored approach to implementing     MBC that will include the integration of symptom monitoring capacities into the electronic     health record system of one of the nation's largest not-for-profit providers of behavioral     health services.   "
77907|NCT02266121|"     Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments     to enhance their cognitive aptitudes.   "
77867|NCT02266641|"     Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms of     one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic     environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome     molecule, to promote the individual nutrient growth factor of growth and development.     Inadequate maternal one-carbon nutrient intake combined with genetic polymorphisms of     one-carbon enzymatic mutation, causing one-carbon malnutrition, change fetal methyl metabolic     nutrition environment. It not only leads to fetal growth mutation - such as folate and     choline deficiency, increasing the risk of fetal neural tube defect but also induce abnormal     modifying of fetuses's post-genomic methylation markers, may alter imprinted genes function     of progenitors, recompile threshold sensitivity or domain in regulation of metabolic     reactions of offspring, resulting in long-lasting effect, increasing the risk of chronic     diseases of offspring such as cancer. According to the National Nutrition Survey results show     that a considerable proportion of the Taiwanese people had poor one-carbon nutritional     status. 48% of women intake 66% below the recommended intake reference value of folate.     Whether inadequate parental one-carbon nutrients intake combined with genetic polymorphisms     of one-carbon enzymatic mutation will cause one-carbon malnutrition of fetus, affecting fetal     growth and modifying the risk of cancer development relationship of offspring. It is due to     the lack of local ethnic data and empirical scientific reference at home and abroad, so it     can not plan an effective maternal and children nutrient education and prevention strategies     about methyl nutrition for early cancer prevention for Taiwanese. Therefore, indigenous     people is the intended population of study in this project, screening of healthy pregnant     women with high risk factor for cancer and obese pregnant women, and detection of one-carbon     nutrient intake and biochemical assessment of the nutritional status of the study group.     Supplying nutrition education intervention or multivitamin supplement to improve the poor     nutritional status of persons. Using related DNA methylation imprint marker about offspring     growth and modifying development of cancer as assessment, this project explores the     appropriate one-carbon nutrient intake in parents and children and the assessments in     regulation of growth and reducing the cancer-related risk.   "
77868|NCT02266628|"     The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine     in elderly subjects, as well as rate the incidence of medically- attended RSV disease in     vaccine and placebo recipients.   "
77869|NCT02266615|"     Collection of coded biomaterial and clinical data with patients consent for future research.   "
77870|NCT02266602|"     Single arm study to assess the effectiveness of single dose intraoperative radiation therapy     in patient with in situ and early stage breast cancer.   "
77871|NCT02266589|"     The purpose of this study is to find out whether stress doses of hydrocortisone attenuate     coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by     which little doses of hydrocortisone influence coagulation system in sepsis.   "
77872|NCT02266576|"     The goal of the proposed research is to identify effective patient-centered strategies to     prevent diabetes in high-risk populations in real world settings. The investigators will     accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes     Prevention Program addressing psychosocial stressors to a standard version in a high-risk     population of urban American Indian and Alaskan Native peoples within a primary care setting.   "
77873|NCT02266563|"     The potential long-term effects of Traumatic Brain Injury (TBI) are poorly understood.     Repeated concussions have been associated with an elevated incidence of Alzheimer's disease     (AD) along with a reduced age of onset. As repetitive TBI has been studied, a syndrome has     now been identified: chronic traumatic encephalopathy (CTE). There are growing concerns about     the long-term neurologic consequences of head impact exposure from routine participation in     contact sports (e.g., boxing, football). Brain autopsies of athletes with confirmed CTE have     demonstrated tau-immunoreactive neurofibrillary tangles and neuropil threads (known as     tauopathy). The relationship between exposure to repetitive head impact and the subsequent     development of chronic neurodegenerative disease has not been established. Further, as the     diagnosis of CTE (defined by the presence of tauopathy) is presently made after death at     autopsy, clinical tools and biomarkers for detecting it remain to be defined.      With the advent of FDA-approved PET amyloid imaging, clinicians and researchers are now able     to estimate plaque density in the brains of living patients. However, there are critical     limitations to amyloid imaging. Current evidence suggests that markers of the presence and     severity of tauopathy may be able to address these limitations. The study will utilize both     [18F] Florbetapir and [18F]-T807 PET imaging to investigate amyloid and tau accumulation in     subjects with a history of concussions. In order to determine whether problems with cognition     and memory are seen within the populations defined for the study, the researchers will     administer a core battery of neurocognitive testing. This battery will assess cognitive     abilities commonly affected by TBI, including processing speed, reaction time, new     problem-solving, executive functions, attention and concentration, and learning and memory.     These tests, in conjunction with the imaging, will be able to determine whether regional     brain activity is associated with specific cognitive problems. The researchers will obtain     PET and neurocognitive data in 3 cohorts: subjects with a history of TBIs, subjects with mild     cognitive impairment (MCI) and no TBI history, and healthy controls.      The investigators aim to determine whether individuals with TBI are on the same trajectory of     neurodegenerative disease seen in AD or in CTE. Because of the overlap in clinical/cognitive     and some behavioral symptoms in AD and CTE, an additional biomarker tool is needed to prevent     misdiagnosis. Accurate diagnosis is crucial in order to provide patients with appropriate     treatment.   "
77874|NCT02266550|"     The aims of this phase I study are to define the metabolism, excretion and pharmacokinetics     of [14C]-BIIL 284 BS after administration of a single oral dose of 25 mg [14C]-BIIL 284 BS in     6 healthy volunteers. Tolerability was also assessed.   "
77875|NCT02266537|"     The study was aimed to evaluate the pharmacological effect of different α-antagonists on     phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for     Intraoperative floppy iris syndrome (IFIS)   "
77876|NCT02266524|"     To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in     children with voiding disorders   "
77877|NCT02266511|"     The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4     mg capsules in healthy male subjects. One is a commercial scale batch produced at the Nishine     facility, and the other is a batch, of equal size, produced at the Norman II facility   "
77878|NCT02266498|"     To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg     BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules   "
77879|NCT02266485|"     Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker),     effect on routine lipid profile parameters, safety and preliminary pharmacokinetics   "
77883|NCT02266433|"     The primary objective of this study is to compare local corticosteroid hand and elbow     injections to placebo or ketorolac to determine if there is an equal or better reduction of     symptoms for common orthopaedic upper extremity disorders including: De Quervain's     tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators     will enroll 780 subjects, divided equally into three arms for each disease process, and     compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring     patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks,     and 6 month followup periods, prospectively over time.   "
77946|NCT02265601|"     This study is designed to help the investigators understand more about how people plan for     their future medical needs, a process known as advance care planning.      The study is under the direction of Michael J. Green, M.D., and Benjamin Levi, M.D.     physicians at Penn State Hershey Medical Center.      Participation in the project takes place during a single visit to the Medical Center campus.     During this one-to-three hour visit, participants complete several questionnaires and use a     computer program that produces a printed advance directive that can be shared with their     physicians and loved ones. Participants will receive compensation toward travel expenses.   "
77884|NCT02266420|"     This is a prospective, non-randomized and multicenter study designed to compare biological     features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus     pT1c T2 ≤ 30 mm.      All consecutive patients will be recruited by each investigator after completion of surgery.     No modification of standard management according to each investigator center will be done.     All patients will then be followed each year during 5 years in order to collect the following     events: local and loco regional recurrence, metastatasis, second cancer, death or not and the     cause.      At initial visit, a 10 mL blood sample will be collected (= study intervention) and     immediately processed for serum storage; all serum samples will be stored at -80°C and may be     used for the purpose of further scientific research.      A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be     addressed at the Institut Claudius Regaud for central collection which will consist of one     haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides     for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).      Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli     Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to     detect gene copy number alterations such as gains/amplifications/deletions, and to next     generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation     detection.   "
77885|NCT02266407|"     To assess the surgical and economic effectiveness of the Aquamantys System in managing intra-     and post-operative blood loss, and reducing transfusion needs in patients undergoing both     aseptic and septic revision total knee arthroplasty.   "
77886|NCT02266394|"     Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at     recovering kidney function. For this reason we are studying a stem cell product called     mesenchymal stem cells or MSC. Mesenchymal stem cells (MSC) are grown from a person's own     fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney.      This study is also being done to determine if the MSC infusion prior to percutaneous     transluminal renal angioplasty with stenting (PTRA) further enhances changes in single kidney     blood flow and restoration of kidney function, as well as to assess the relationship between     MSC dose and measures of kidney function.   "
77887|NCT02266381|"     Purpose:      The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US)     and US combined with fluoroscopy in the guidance of minimally invasive percutaneous     nephrolithotomy (MPCNL).      Methods:      The investigators will enroll 450 patients who are candidates for MPCNL in our study. By     simple random sampling technique, patients will be assigned to three 150-patient groups     (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with     fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the     procedure is the same in all three groups.The end point of the study is the comparison of     outcome of procedure including stone free rate, transfusion rate, operation time, access     time, length of stay and complications.   "
77888|NCT02266368|"     This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent     with non-coated stents in prevention of UTI in patients with ureteral stents   "
77889|NCT02266355|"     Pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin     hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study will also     evaluate the safety of omalizumab (Xolair) when administered in this setting.   "
77890|NCT02266342|"     This is a French Registry mandated by the French National Health Authority assessing     long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the     thoracic aorta.   "
77891|NCT02266329|"     The purpose of this study is to determine if prazosin is more effective than placebo in     decreasing frequency, severity, disability, and other negative effects of headaches related     to mild traumatic brain injury in Service Members and Veterans.   "
77892|NCT02266316|"     The World Health Organisation defines chronic obstructive pulmonary disease (COPD) as 'not     one single disease but an umbrella term used to describe chronic lung diseases that cause     limitations in lung airflow' covering emphysema and chronic bronchitis; and estimates (2004)     that worldwide there are currently 64 million sufferers with 3 to 4 million in the UK.      COPD results from damaged airways in the lungs, causing them to become narrower and making it     harder for air to get in and out of the lungs. It is diagnosed by measuring the amount of air     that can be expelled in the first second of breathing out (FEV1) in litres per second.      COPD is a progressive disease and the condition can have a serious impact on the quality of     life of sufferers. Going out in very cold weather can cause an immediate drop in FEV1, and     increased breathlessness.      This is a randomised crossover controlled trial of participants with COPD. It compares the     effectiveness of an air-warming face mask which covers the mouth compared with no face     covering, in increasing participants exercise capacity and quality of life in cold weather.     The mask warms air at the mouth by drawing on air warmed beneath the participants clothing,     through a 20cm long hollow plastic tube and a one-way inspiratory valve into the mask. Air is     expired through the nose.      24 participants with moderate or severe COPD, will undertake 3 exercise tests on 3 separate     days. Two tests will be in an environmentally controlled chamber performed at 5°C with     participants wearing either the mask or no face covering. The third test will be performed at     ambient temperature outside the chamber.      The order will be determined by random allocation. Participants will undergo the Treadmill 6     Minute Walk Test; various measurements will be taken, all of which will be non-invasive.   "
77902|NCT02266186|"     The purpose of this project To study the efficacy of Internet-based guided self-help program     of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group     of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a     control group receiving individual support at their antenatal clinics.   "
77893|NCT02266303|"     The increasing prevalence of diabetes is associated with increased insulin use. In developing     countries it is frequently necessary to use insulin, with the needle and syringe method of     administration being the cheapest approach. Competence of health care professionals is     required to safely initiate insulin. The investigators will evaluate whether using a     checklist during insulin initiation with a needle and syringe, can improve the safety and     efficacy of its use.   "
78000|NCT02264899|"     A Multicenter national longitudinal cohort study including at least 800 individuals recruited     from French Research Memory Centers and followed up over 36 months and included in Memento.   "
77894|NCT02266290|"     The Objective is to examine the immediate and prolonged effects (seven days) of Kinesio® Tape     (KT) on balance in subjects with chronic ankle instability using Computerized dynamic     posturography (CDP). Design. A 7 days follow-up, single-blind randomized controlled trial.     Setting. University community. Participants. A sample of 30 subjects aged 18 to 28 with CAI     and subjective perception of ankle instability (FAI) was enrolled in this study.     Interventions. Participants will be randomly divided into two groups: an experimental group     in which was applied KT, and a control group in which was applied a placebo tape.Objective.     To examine the immediate and prolonged effects (seven days) of Kinesio® Tape (KT) on balance     in subjects with chronic ankle instability using Computerized dynamic posturography (CDP).     Design. A 7 days follow-up, single-blind randomized controlled trial. Setting. University     community. Participants. A sample of 30 subjects aged 18 to 28 with CAI and subjective     perception of ankle instability (FAI) was enrolled in this study. Interventions. Participants     were randomly divided into two groups: an experimental group in which was applied KT, and a     control group in which was applied a placebo tape. Main Outcome Measure(s). The CDP device     employed in this study was Smart Equitest® version 8.2. CDP analysis was conducted using the     Sensory organization test (SOT). The composite SOT score (COMP) and the composite SOT     strategy (STR), the partial score for SOT condition 2 (SOT 2) and its strategy (STR 2) were     considered as outcomes measures.   "
77895|NCT02266277|"     The goal of this research study is to improve rates of appropriate influenza and pneumococcal     vaccination among adults who receive care at a large multi-specialty group practice in     central Massachusetts.      The investigators plan to conduct a non-blinded randomized controlled trial during flu season     2014-2015 (Cycle 1). A total of 20,000 e-portal users and 10,000 non e-portal users who are     identified in the Reliant Medical Group (RMG) Electronic Health Record (EHR) as not being up     to date on their influenza vaccines will be randomized.      E-portal users will be randomized to receive:        -  Arm 1: E-portal message with Interactive Voice Recognition (IVR) call        -  Arm 2: E-portal message with no IVR call        -  Arm 3: No e-portal message with IVR call OR        -  Arm 4: No e-portal message with no IVR call (Control, e-portal users)      Non e-portal users will be randomized to receive either:        -  Arm 5: IVR call OR        -  Arm 6: no IVR call (Control, non e-portal users)   "
77896|NCT02266264|"     The purpose of this study is to compare hyperglycemia and other effects, include 28-day     mortality and time to reversal of shock between 100 milligrams and 200 milligrams of     hydrocortisone as initial dosage in patients with septic shock.   "
77897|NCT02266251|"     Disease of the aortic heart valve is both common and progressively disabling, with no     effective medical treatment. In November 2011, the United States Food and Drug Administration     (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve     replacement (AVR). This new technology has changed the treatment of patients with aortic     valve disease. In doing so, it has created a pressing clinical need for shared decision     making tools that will help patients understand the risks and benefits of each treatment     alternative in the setting of their individual characteristics.      The overarching goal of this study is to develop a new way to approach the treatment of     medical illness, by focusing on the expected treatment outcomes for individual patients using     information collected from large groups of patients. The corner-stone of this model is a     public website that is designed to engage patients and clinicians in a personalized     discussion of treatment alternatives. To achieve this goal for patients with aortic valve     disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and     American College of Cardiology (ACC) national procedural registries that has been linked to     Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical     versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create     and evaluate personalized decision assistance tools for all patients considering AVR. This     work will be accomplished in direct partnership with both patients and caregivers as well as     a diverse group of stakeholders who will help ensure its usefulness and dissemination.   "
77898|NCT02266238|"     The purpose of this study is to compare the effect of DSA guided percutaneous balloon     dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the     treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.   "
77899|NCT02266225|"     The goal of this study is to evaluate how to implement an evidence-based lifestyle-integrated     strength and balance exercise (LiFE) intervention in primary care to promote increased     physical activity (PA) and improvements in function and quality of life in older adults 75     years or older. This study will evaluate the public health impact of the LiFE intervention     using the RE-AIM model: reach (recruitment), effectiveness (PA levels), adoption (physician     acceptance), implementation (fidelity), and maintenance (retention, adherence). If the     intervention appears feasible, we will use the resultant information to design a larger     pragmatic trial.   "
77900|NCT02266212|"     Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among     current, past and non smokers are determined by comparing and analyzing frequency     distributions. To determine whether smokers require more post operative opiate analgesics     than others. Multivariate analysis will be performed to identify the major and the minor     factors predicting the use of postoperative pain therapy. Our previous related study showed     that the smoker male patients consumed more analgesics than those without smoking, but the     female group showed the similar findings. However, the case number, especially the female     cases, is underpowered. Investigators hope to increase the case number to have a better     statistical and clinical significance.   "
77901|NCT02266199|"     The study includes operative as well as conservative patients using a questionnaire     containing items of pain quality. After having completed the questionnaire, the patient is     interviewed by an assistant. By this way the new questionnaire should be validated.      In addition the patient´s personal experiences are included and conservative patients can be     compared to operative patients.   "
77947|NCT02265588|"     The presented study aims to reduce symptoms of depression and anxiety in adolescents with     inflammatory bowel disease and increased symptoms of anxiety and depression by using the     disease specific CBT program (PASCET-PI)in order to improve quality of life and to improve     the clinical course of disease.   "
79754|NCT02241993|"     The purpose of the study is to test the accuracy benefit of having two glucose sensors (over     one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet     known how close two sensors can be and still work correctly.   "
77908|NCT02266108|"     The proposed research aims to pilot a multi-strategy structural intervention combining     community mobilization to promote gender equity alongside an economic intervention     (microfinance and business training) in order to reduce gender-based violence and HIV risk     among female sex workers (FSW) in Tijuana, Mexico. The program will be called ESTIMA:     Economic and Social Empowerment To Increase Upwards Mobility Among Women. The evaluation     will employ a randomized controlled design, recruiting FSW (n=120, 60 in each arm) who will     be randomized to: 1) ESTIMA (gender equity/community mobilization program and economic     intervention) or 2) a wait-list control group. For this preliminary work, at 12 months     follow-up, we hypothesize that compared to control participants, intervention participants     will have: 1) significantly greater economic security (e.g. decreased debt, increased income,     decreased number of sex trades) and 2) significantly greater perceived collective power (i.e.     collective efficacy) to address gendered power imbalances within social structures and the     community. The long-term goal of this program, upon future refinement and large scale     implementation, is to reduce HIV risk behaviors, STI/HIV, GBV, and ultimately, alleviate a     multitude of health burdens among women. Furthermore, we expect that such work will highlight     the need for HIV prevention initiatives in Mexico, and elsewhere, to more broadly consider     women's 'life contexts' - addressing economic and social burdens in women's lives, to reduce     the burden of poverty, gender, and HIV, as well as the intersection of these among women.   "
77909|NCT02266095|"     The oval-8 splint has been developed for many uses in finger pathology and trauma. It has     not, however, been used to treat thumb carpometacarpal (CMC) joint arthritis. When treating     thumb CMC joint osteoarthritis, splinting is a very widely used and supported treatment     option for non-operative management. Many studies have been performed showing that thumb     spica splinting in abduction with either a hand based or forearm based splint improves pain.     This study aims to compare the effects of a novel splinting approach with oval-8 splints for     the hyperextended thumb interphalangeal (IP) joint vs. standardized treatment with Tee Pee     splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of     patients with thumb CMC joint arthritis.      This is a pilot study will address the following hypothesis: Splinting of the hyperextended     thumb IP joint with oval-8 splints will lead to increased DASH scores and decreased pain on     physical exam compared to splinting with thumb spica splints in patients with thumb CMC     arthritis.   "
77910|NCT02266082|"     Women with early-stage breast cancer (BrCA) are surviving longer, but many experience     symptoms after curative treatments. Approximately 50% of BrCA survivors experience persistent     pain post-surgery. Identifying individuals at high risk for long-term symptoms is important     for restoring function and enhancing quality of life. This pilot study will investigate     psychological (depression, anxiety, catastrophizing) and biological (inflammatory markers,     gut microbiome, pain sensitivity) correlates of persistent post-surgical pain in women     participants with early-stage BrCA. The investigators will also investigate the type of     surgery that participants had and whether it is related to persistent pain. The investigators     plan explore these factors over time.   "
77911|NCT02266069|"     It is important to provide high quality palliative care to all patients with a non-curable     and life-limiting condition. The Care Pathway for Primary Palliative Care (CPPPC) provides     tools for health care professionals to help them delivering palliative care timely and     accurately.This study investigates whether the implementation of the CPPPC really helps to     improve patients' lifes.   "
77927|NCT02265861|"     This research is to investigate the response of vascular active factors, vascular endothelial     growth factor (VEGF) and angiotensin-Ⅱ (AT-Ⅱ) to ovary stimulation during 24h in patients     with polycystic ovary syndrome (PCOS).Controled prospective clinical study involved 60 women     undergoing in vitro fertilization. Fifty-two patients with PCOS and 8 control cases were     stimulated with human chorionic gonadotropin (HCG) during the early follicular phase of the     menstrual cycle (4st to 7th days of the cycle).The blood was sampled before the injection (0     hour) and at the 3, 6, 12, 18 and 24 hours points after the stimulation. VEGF, AT-Ⅱ were     measured by radioimmunoassay.   "
77928|NCT02265848|"     Study designed to compare the conventional stimulation programming versus the high frequency     stimulation programming of the spinal cord stimulator for subjects who already have a spinal     cord stimulator.   "
77929|NCT02265835|"     Retrospective analysis of data concerning anastomotic airway complications after lung     transplantation.   "
77912|NCT02266056|"     Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of     hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an     increased mean arterial pressure and systemic vascular resistance due to sympathetic     excitation in the cardiovascular system. 10~15 mmHg intra-abdominal pressure is required in     order to achieve a pneumoperitoneum, and increased abdominal pressure following a     pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by     increasing the left ventricular end systolic wall stress and the right and left ventricular     filling pressure, while decreasing the stroke volume and cardiac index. The author compared     the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle     relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for     colorectal cancer as part of preliminary research. The results showed that deep muscle     relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal     pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by     an average of 8. Above all, even after lowering the intra-abdominal pressure with deep muscle     relaxation, the surgeon was able to maintain a view almost identical to the one afforded by     medium muscle relaxation. However, up until now, no reports have clearly indicated the change     in pneumoperitoneum pressure, the patient's hemodynamic change, post-operative recovery, and     surgical prognosis depending on the depth of muscle relaxation.Against this background, this     study aims to identify the degree to which intra-abdominal pressure in laparoscopic     colorectal surgery can be reduced by deep muscle relaxation, and the corresponding advantages     this method presents in terms of physiological changes such as hemodynamic and respiratory     system changes. In addition, the study intends to examine the difference between deep muscle     relaxation and medium muscle relaxation in terms of surgical prognosis, including their     effects on post-operative pain and on the patient's recovery of intestinal mobility.   "
77913|NCT02266043|"     In a longitudinal cohort study, we want to assess the effect of the pre-epiglottic baton     plate, the main treatment approach currently used in Germany for Pierre-Robin-Like phenotype,     on upper airway obstruction and failure to thrive using objective criteria (mixed-obstructive     apnea index assessed by polysomnography, standard deviation score for body weight) upon     admission and 3 months after hospital discharge.   "
77914|NCT02266030|"     This is a prospective interventional study to assess the effect of cilostazol compared with     aspirin in Korean T2DM patients with atherosclerosis.   "
78038|NCT02264405|"     To assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for     early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by     different study protocols used across Europe in various EBMT centres through the careful     recording and analysis of routinely collected clinical and biological data.   "
77915|NCT02266017|"     Pain in cancer patients is estimated to be as high as 90% and results in physical and     psychological disability. Behavioral interventions that increase patients' confidence in     their ability to manage their pain have been shown to be beneficial. Behavioral interventions     for cancer pain teach patients how their thoughts and feelings can influence their pain and     specific strategies (e.g., relaxation) for decreasing cancer pain. However, despite     guidelines recommending such interventions be used in the care of cancer patients with pain,     they are not routinely used. A critical barrier to the use of behavioral interventions is     that patients have difficulties attending appointments which are typically offered at the     medical center during normal business hours. Mobile health (mHealth) technologies provide new     opportunities to decrease such barriers. The investigators have developed a new mHealth     approach that may increase the use of behavioral cancer pain interventions and ultimately     lead to greater use of interventions that can decrease pain and disability.      The investigators propose to test an approach that uses mHealth technologies to deliver a     behavioral cancer pain intervention to patients in their home using a tablet computer (e.g.,     iPad) and video-conferencing (e.g., Skype). The investigators will randomly assign 160 cancer     patients with breast, lung, prostate, or colorectal cancer pain to receive either mHealth     Pain Coping Skills Training system (mPCST) or to receive a traditional in-person pain coping     skills training intervention protocol (PCST-trad) at the medical center. The investigators     will test whether the mPCST is more accessible to patients than PCST-trad. The investigators     expect that mPCST, compared to PCST-trad, will: a) be more feasible meaning that more     patients will complete it in a timely manner; b) create less burden meaning it is easier for     patients physically, emotionally, and financially to participate; c) increase engagement     meaning that patients will practice skills more and have more understanding of the material;     and d) be more overall acceptable to patients. the investigators also expect that patients     who find this intervention more feasible, less burdensome, more engaging, and more acceptable     will be more likely to experience decreased pain, physical disability, and psychological     disability, and increased confidence in their ability to manage their pain.      The investigators' goal is to use mHealth technologies to facilitate wide-spread use of     behavioral cancer pain interventions. Increased use of mHealth behavioral cancer pain     interventions will particularly benefit patients living far from medical centers (e.g.,     rural), experiencing cancer-related physical challenges, and facing other practical barriers     (e.g., transportation, work) to in-person interventions. These outcomes could lead to future     work evidencing that mHealth behavioral interventions could be applied to other areas of     quality of life in cancer patients (e.g., fatigue) and/or in other samples of patients with     persistent pain (e.g., arthritis).   "
77916|NCT02266004|"     This study will evaluate the effcts of transcranial direct current stimulation (tDCS) in     combination with locomotor training in patients with Parkinson's disease (PDD) and freezing     of gait (FOG).   "
77917|NCT02265991|"     Pre- and postoperatively patients who underwent free fibula flap were examined regarding     donor-site morbidity of the lower extremities.   "
77918|NCT02265978|"     This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting     positive mental health through emotional self-awareness in adolescents. Participants will be     recruited from second-level schools in Ireland. Schools will be randomly assigned to the     intervention or control condition. Participants in the intervention condition will use     CopeSmart for a four week period. Those in the control condition will not use any mental     health app.   "
77919|NCT02265965|"     Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second     stage arrest of descent to prevent or uterine extension at the hysterectomy site.   "
77920|NCT02265952|"     This is an open-label, single-arm study to assess the reduction of low-density lipoprotein     cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia     (HoFH).   "
77921|NCT02265939|"     Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13     per contraction region of large bowel up to fifth times during the colonoscopy.      The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with     no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be     assessed by an independent committee using recorded video images.      The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions     (ADRs) observed between administration and seven days after administration.   "
77922|NCT02265926|"     The study aims to find out if usage of N95 type respirators affects respiratory parameters in     pregnant women so as to provide guidance on N95 respirator usage in pregnant healthcare     workers.   "
77923|NCT02265913|"     To compare safety and efficacy of Perrigo's antiviral drug product compared to an FDA     approved antiviral drug product in the treatment of cold sores.   "
77924|NCT02265900|"     The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported,     however the mechanisms are unknown. The purpose of this study is to investigate the potential     mechanisms of exercise in the brain for the treatment of PD.   "
77925|NCT02265887|"     The study will recruit and follow up patients for six months patients newly diagnosed with     pulmonary hypertension from twelve centers across four countries; South Africa, Mozambique,     Cameroon, Nigeria. The main aim of the study is to describe the aetiology, natural history     and management practices of pulmonary hypertension in Africa.   "
77926|NCT02265874|"     The purpose of this study is to determine if nicotine treatment is beneficial for the     treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to     inflammation. This disease affects your body's organs.   "
77945|NCT02265614|"     This project intends to use preimplantation genetic screening (PGS) with the microarray     technique to determine the chromosome composition of fertilized eggs, so that only     chromosomally normal embryos are transferred during IVF. The purpose is to increase the     probability of pregnancy and childbirth among couples with a history of repeated unsuccessful     IVF attempts.   "
77930|NCT02265822|"     Melatonin has been proposed as alternative to midazolam as a premedication in procedures     preceding anaesthesia induction. The objective of this prospective, randomized, double-blind     study is to investigate the possible effect of melatonin premedication on the required     infusion of propofol in comparison to midazolam, evaluating the efficacy of oral melatonin on     sedation in children undergoing surgery.      Preoperative anxiety and postoperative analgesia are also assessed in both groups.   "
77948|NCT02265575|"     One of the leading health issues among patients, particularly children, presenting for care     in low- and middle-income countries is dehydration. When oral rehydration is not sufficient     or is clinically inappropriate, rehydration often occurs intravenously. An alternative to     intravenous rehydration is subcutaneous infusion and - with or without hyaluronidase enzyme     (or Hylenex) - has been shown in several robust trials in high-income countries to be as     effective and even safer than intravenous infusion. In this study in western Kenya, the     investigators propose a first-ever randomized controlled trial to evaluate whether     hyaluronidase-facilitated subcutaneous infusion can be as effective and safe as IV therapy     among moderate-to-severely dehydrated patients in low- and middle-income countries.   "
77949|NCT02265562|"     Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur     in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol     success in reducing blood loss during total abdominal hysterectomy when used once before the     surgery.   "
79755|NCT02241980|"     Evaluation of patients' methodology and ability to select an economical and ideal Medicare     Part D prescription drug plan (PDP).   "
77931|NCT02265809|"     Type 1 diabetes (T1D) is the most common severe autoimmune disease worldwide and is caused by     the body's immune destruction of its own insulin producing pancreatic beta cells leading to     insulin deficiency and development of elevated blood sugars. Currently, medical management of     T1D focuses on intensive insulin replacement therapy to limit complications (retinopathy,     nephropathy, neuropathy); nevertheless clinical outcomes remain suboptimal. There are     intensive efforts to design novel immunotherapies that can arrest the autoimmune process and     thereby preserve residual insulin production leading to fewer complications and better     clinical outcomes.      Genetics are in part the cause of T1D and the majority of genes contributing to T1D produce     proteins involved in immune regulation (called tolerance). A key player in immune tolerance     is a molecule called interleukin-2 (IL-2) which enhances the ability of cells called T     regulatory (Treg) cells to suppress the destruction the insulin producing beta cells.     Aldesleukin is a human recombinant IL-2 product produced by recombinant DNA technology using     a genetically engineered E. coli strain expressing an analogue of the human IL-2 gene. There     is substantial data to suggest that ultra-low doses (ULD) of IL-2 (aldesleukin) can arrest     the autoimmune mediated destruction of pancreatic beta cells by the induction of functional     Treg cells.      The former study Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes     (DILT1D) (NCT 01827735) was a single dose mechanistic study designed to establish the doses     of IL-2 (aldesleukin) required to induce a minimal Treg increase (0.1 fold from baseline) or     to induce a slightly larger Treg increase (0.2 fold from baseline) (maximal increase).     Following on from the DILT1D study, the goal of the DILfrequency study is to use an adaptive     design to determine the optimal dose and frequency of ULD IL-2 (aldesleukin) to maximize Treg     function by frequently injecting ultra-low doses of IL-2 (aldesleukin). The responsiveness of     each T1D participant to a particular frequency of IL-2 (aldesleukin) administration informs     the frequency of dosing given to the next patient. This strategy focuses on improving the     function of regulatory T cells that are exquisitely sensitive to IL-2 (aldesleukin).   "
77932|NCT02265796|"     This is a prospective, double-blind, placebo-controlled, randomized, single-center (North     Florida- South Georgia VA Medical Center) study. The study objective is to determine if     ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary     artery disease patients who have demonstrable myocardial ischemia, but who do not undergo     revascularization   "
77933|NCT02265783|"     The purpose of this study is to validate that the device posts a Sensor-Off message within     the time frame stated in the proposed claims.   "
77934|NCT02265770|"     The overall aim of this project is to improve the outcome of patients diagnosed with     ependymoma by improving and harmonising the staging and the standard of care of this patient     population and to improve the investigators understanding of the underlying biology thereby     informing future treatment.      The program will evaluate new strategies for diagnosis (centralized reviews of pathology and     imaging) and new therapeutic strategies in order to develop treatment recommendations.      Patients will be stratified into different treatment subgroups according to their age, the     tumour location and the outcome of the initial surgery. Each subgroup will be studied in a     specific randomised study to evaluate the proposed therapeutic strategies.      Stratum 1:      The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen     with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression     free survival in patients who are > 12 months and < 22 years at diagnosis, with completely     removed intra cranial Ependymoma.      Stratum 2:      This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years     at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving     to all patients the benefit of VEC chemotherapy whilst randomising half of patients to     receive additional HD-MTX.      Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual     inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the     residual tumour will be delivered immediately after the end of the cRT.      Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of     postoperative dose intense chemotherapy administered alone or in combination with valproate     in children <12 months of age or those not eligible to receive radiotherapy .   "
77935|NCT02265757|"     This study will compare the effectiveness of different combinations of 5 types of behavioral     interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g.     quality of life, cognition, function, mood) matter most to people at risk for dementia and     their care partners. The results of this study have the potential to direct patients,     families, and health care providers as to which combinations of behavioral interventions     provide the greatest potential impact on which dementia prevention outcomes. Greater use of     behavioral strategies that are targeted to the outcomes of most important to the patient will     likely improve patient compliance and treatment adherence. This, in turn, can lessen the need     for medication, health care, and long term care utilization.   "
77936|NCT02265744|"     Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic     lupus erythematosus in male and female adults. Patients who qualify will be randomized to     either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the     initial 24 weeks of treatment and who are responding to therapy will have the option to     continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and     safety will be assessed over the course of the study through laboratory values, various     rating scales accepted in systemic lupus erythematosus studies and patient self reporting.   "
77937|NCT02265731|"     This study is evaluating the safety and pharmacokinetic profile of venetoclax under a once     daily dosing schedule in Japanese participants with hematological malignancies.   "
77938|NCT02265718|"     The purpose of the study is to evaluate the difference in learning and performance measures     associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in     healthy elderly volunteers based on amyloid status.   "
77939|NCT02265705|"     The main purpose of this study is to evaluate the safety and effectiveness of the study drug     known as baricitinib in participants with moderately to severely active rheumatoid arthritis     who have had an inadequate response to methotrexate therapy.   "
77940|NCT02265679|"     Safety, tolerability and pharmacokinetics following single doses   "
77941|NCT02265666|"     The objective of the present study is to investigate the relative bioavailability of BIIL 284     BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in     healthy male volunteers   "
77942|NCT02265653|"     The objective of the present study is to investigate the relative bioavailability of two BIIL     284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg     following a standard breakfast in healthy male volunteers   "
77943|NCT02265640|"     The objective of the present study is to investigate the relative bioavailability of BIIL 284     BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a     standard breakfast in healthy male volunteers   "
77944|NCT02265627|"     To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic     impairment in comparison to healthy subjects   "
81161|NCT02223598|"     The purpose of this study is to determine the safety, tolerability, dose limiting toxicities,     and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies.   "
77950|NCT02265549|"     Published prognostic scores have limitations in prediction of long term survival after     stereotactic radiotherapy for brain metastases. Moreover, no validated tools are available     for prediction of local failure. The value of radiomics is evaluated in this perspective.   "
79765|NCT02241850|"     The objective of the study is to investigate the effect of high intensity training on maximal     oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.   "
77954|NCT02265497|"     Currently there are no official data concerning incidence, progression and prognosis of     patients with lymphoma in Brazil.This project aims the establishment of a network of 12     Brazilian Institutions to implement a Lymphoma Registry (RELINFO) with the Brazilian National     Cancer Institute (INCA) as the Coordinating Center.We intend to develop and implement a     computerized system for data entry and information management of patients with lymphomas.     This will enable create a virtual registry of demographic, clinical, epidemiological,     histopathological, molecular, and therapeutic data. This clinical record must be linked to     histopathological and molecular diagnosis, allowing institutions that work in the context of     the public health system have access to new technologies for early cancer diagnosis.We expect     is that this record reliably portrays the scene of lymphomas in our state and will become a     management model that can be replicated at the national level. Thus, the implementation of     RELINFO will strengthen the multidisciplinary diagnosis, promote the standardization of     clinical record of patients with lymphomas and provide subsidies to cooperative research     projects between participating institutions.   "
77955|NCT02265484|"     After successful screening of liver cirrhosis patients attending ILBS OPD for signs of     parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis     related parkinsonism will be made. Patients will be randomized into Bromocriptine and     Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS     (Institute of liver & Biliary Sciences) for 3 months. Detailed neurological examination will     be done at each visit & UPDRS (Unified Parkinson's Disease Rating Scale ) score will be     calculated.   "
77956|NCT02265471|"     The objectives of this survey are to determine the level of antimicrobial resistance     knowledge and perception of health care workers (HCW) in France, to measure the impact of     health care facilities (HCF) and to identify the drivers and barriers to change. To achieve     this goal, a cross-sectional survey on one day with a self-administered questionnaire and     semi-structured interviews with HCWs is proposed. This study will be planned in 60 different     HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.   "
77957|NCT02265458|"     Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure,     and intubation. Music therapy has been used in various clinical context, including in ICU     patients under mechanical ventilation. We aim to evaluate the effect of a musical     intervention on respiratory comfort during NIV for acute respiratory failure.   "
77958|NCT02265445|"     The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to     another beta-lactam for which the isolated pathogen is susceptible) in patients with     well-defined ESBL-PE infections (usual sites of infections and non severe infections).   "
77959|NCT02265432|"     The purpose of this study is to test an intervention which uses a personalized     mobile-technology based approach that aims to promote physical activity and reduce sedentary     behaviour in inactive working Singaporean adults.   "
81202|NCT02223065|"     The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy     subjects.   "
77960|NCT02265419|"     Heart-surgery with the use of a heart-lung-machine can trigger the development of a     full-blown SIRS (Systemic Inflammatory Response Syndrom) with multi organ failure and severe     sepsis in the course of disease.      For the treatment of full-blown SIRS extracorporeal treatment like the Cytosorb-Adsorber are     in clinical testing. The Cytosorb-Adsorber is a CE-signed medical device with approval for     the treatment of severe sepsis and hyperinflammation. The adsorber remove not-specific     cytokines and other inflammation mediators from the patients blood.      In this study (as a case-observation and compassionate use) the effect of extracorporeal     treatment with the Cytosorb-Adsorber for the reduction of postoperative hyperinflammation and     SIRS after heart-surgery with use of a heart-lung-machine will be observed.      The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber     on the course of hyperinflammation and multi organ failure in comparison with a historic     control group.   "
77961|NCT02265406|"     Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections     in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases     morbi-mortality, length of stay in intensive care and overall management costs. The     prevention of ICU nosocomial infections depends on several measures : orotracheal intubation     route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a     semi-seated position >= 30°, nasal and oropharyngeal care at regular intervals, striving to     avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for     early weaning from ventilation. Two randomized study show that administration of antibiotic     therapy after intubation reduces the risk of early VAP incidence. However, in clinical     practice, its administration solely purposes of limiting VAP occurence is not presently     recommended. Indeed, to date no placebo blind controlled study was been realized and the fear     of development of bacterial resistance remains stronger than the efficiency of this     prevention measure. This aim of the present study is to show by a placebo randomized study     that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk     of occurence an early VAP.   "
77962|NCT02265393|"     This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United     Kingdom. The first part is a randomized, placebo-controlled study comparing the safety     profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an     open-label extension where all subjects will receive an additional 2 intratympanic injections     of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1     year.   "
77963|NCT02265380|"     A prospective, single-center, open-label, randomized controlled trial to demonstrate the     safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study     hypothesis is that OptiVein IV Catheter use will be superior to the control in successful     venous access after first attempt.   "
77964|NCT02265367|"     The purpose of this study is to provide preliminary information assessing if levomilnacipran     may be effective at increasing smoking cessation rates.   "
77965|NCT02265354|"     This study will advance computer tailoring by adapting machine learning collective     intelligence algorithms that have been used outside healthcare by companies like Amazon and     Google to enhance the personal relevance of the health communication.   "
77967|NCT02265328|"     Severe Alcoholic hepatitis (SAH), defined by modified Maddrey's Discriminant Function (DF)     ≥32, is associated with significant morbidity and mortality. Of the various treatment     modalities evaluated for treatment of SAH, corticosteroids have been the most extensively     studied. Five out of 13 RCTs, and four out of 5 meta-analysis have shown a survival benefit     with corticosteroids, especially in patients with DF ≥32 and/ or encephalopathy.However, the     role of corticosteroids in SAH still remains somewhat controversial. Corticosteroid therapy     is not considered the ideal option by all authors because their beneficial effect seems to be     confined to a highly selected minority group in which the inhibitory effect of     corticosteroids on liver inflammation is not outweighed by side effects such as weakened     defence against infections, anti-anabolic effects, and possible ulcer promoting effects. Also     corticosteroids are contraindicated in patients with renal failure, gastro-intestinal (GI)     bleed, pancreatitis and active sepsis. Therefore, there have been constant efforts to     evaluate new therapies for SAH. In a recent trial, combination of glucocorticoids plus     N-acetylcysteine was found to improve one month survival in patients with SAH, compared with     glucocorticoids alone. However the 6 month survival was not different in both groups.      Human Colostrum (HC) and Bovine Colostrum (BC) are rich in protein, immunoglobulin,     lactoferrin and growth factors. Recent studies suggest that colostrum components,     Lactroferrin, immunoglobulin and growth factor benefits physically active person and in     treatment of autoimmune disorders. It is used for the treatment of a wide variety of     gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut     injury, H pylori infection, immune deficiency related diarrhea as well as infective diarrhea.      The guidelines by American College of Gastroenterology and other authors have suggested that     a combination of CS and other drugs, which have different mechanisms of action, may be more     beneficial for reducing mortality in SAH. Hence, we plan to conduct this pilot study to     investigate the efficacy of a novel combination of corticosteroids, and Bovine colostrum in     the treatment of SAH.   "
77968|NCT02265315|"     The purpose of this study is to evaluate the impact of a non-invasive brain stimulation     technique called transcranial magnetic stimulation (TMS) on voice/speech treatment in people     with Parkinson's Disease (PD), through the use of speech and voice analysis, examination of     voice box, and brain imaging methods.   "
77969|NCT02265302|"     Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the     pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by     determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary     pharmacokinetic data as well as first information on food effects after administration of the     75 mg WIF tablet in healthy male volunteers   "
77970|NCT02265289|"     To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg     Lefradafiban tid   "
77971|NCT02265276|"     Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic     syndrome. The prevalence of the same has been increasing rapidly in India, along with an     increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying     pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and     the therapeutic options are limited. Insulin sensitizing drugs are used in the management of     NAFLD.   "
77972|NCT02265263|"     The research leading consortium to these results has received funding from the European Union     Seventh Framework Programme [FP7/2007-2013] under grant agreement no 602461 (www.biocog.eu).      The investigators will establish valid biomarkers panels (neuroimaging and molecular) for     risk and clinical outcome prediction of postoperative delirium (POD)/postoperative cognitive     deficit (POCD) in N = 1200 elective surgical patients (Age ≥ 65 years) in study centers in     Berlin,Germany (data collection within 5 years after initial hospital stay) and Utrecht, The     Netherlands (data collection within 1 year after initial hospital stay), thereof     cerebrospinal fluid (only once on day of surgery in patients with planned spinal     anesthesia/combined spinal epidural analgesia in N = 200 patients, only in Berlin).     Post-mortem samples of brain tissue are analyzed in a limited number of voluntary patients,     only in Berlin.      A control group of 300 ASA II/III- patients is collected for measuring the learning     experience during the cognitive testings. The participants are matched on age, education, and     gender to the study patients. The 300 ASA II/III- control patients receive additionally     MRI-scan (3 Tesla) at baseline, after 3 months and after 1, 2 and 5 years.      A retrospective control group (extracting 800 intensive care unit patient data from the     patient data management system during the BioCog study period) to analyse economic effects     that are caused by the implementation of quality indicators in health care.      An interim-analysis is performed on the primary endpoint after 400 included patients.      The resulting (multivariate) expert system is expected: 1) to support clinical     decision-making in patient care, e.g. to balance the individual POD/POCD risk against the     expected overall clinical outcome of an (elective) surgical intervention, 2) to allow the     design of more sophisticated and hypothesis-driven clinical studies and drug trials     (translational research) in the future. The latter will be possible on the basis of     biomarker-based sub-grouping of patients and a better understanding of relevant     pathophysiological processes.      Furthermore, a state-of-the art clinical database and biobank will be created that does not     yet exist worldwide. Both the expert system and the reference database/biobank will expand     the leadership of the contributing academic institutions in this particular research area. In     addition, the newly created biobank will become an integral part of the European Biobanking     and Biomolecular Resources Research Infrastructure (BBMRI) which allows top address specific     and hypothesis-driven research questions.      Most notably, the developed (multivariate) expert system also has the potential for     commercialization. Possible customers are: 1) physicians and hospital departments being     involved in pre-surgical decision making, 2) pharmaceutical industry intending to conduct     biomarker-based drug trials in POD/POCD.   "
81898|NCT02213991|"     The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy     for the replacement of boost-external beam radiotherapy in Korean women who are candidates     for breast-conserving treatment.   "
77973|NCT02265250|"     Cardiovascular disease (CVD) remains the leading cause of death in the United States, and     improved CVD risk assessment is needed for personalized medicine. Atherosclerosis measures     including plaque volume and adverse plaque features have prognostic value. Novel techniques     have been developed for assessing carotid, coronary, and femoral atherosclerosis using     magnetic resonance imaging (MRI) methods that are rapid and reproducible, have improved     spatial resolution, and do not require contrast media, making atherosclerosis assessment in     multiple vascular beds feasible during a single MRI session. This pilot research will provide     preliminary data to develop an innovative global atherosclerosis measure including carotid,     coronary, and femoral vascular beds, for assessing cardiovascular risk and for monitoring     atherosclerosis response to therapy. 20 participants will be recruited in one year.   "
77974|NCT02265237|"     The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis     is to assess the safety and to compare the percentage of participants achieving a 12-week     sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of     quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold     [based on SVR rates for HCV genotype 4-infected participants treated with pegylated     interferon (pegIFN)/RBV].   "
77975|NCT02265224|"     This is single centre, single dose, open, randomised, cross-over, two-stage bioequivalence     study to compare two different oral formulations of NAC.      The study has been conducted in healthy volunteers of both genders, in one single dose of     both formulations.   "
77976|NCT02265211|"     This study evaluates a self-help app in the treatment of shyness and social anxiety in     adults. All participants will be assigned to the treatment group. It is expected that using     this app will result in a reduction in social anxiety.   "
77977|NCT02265198|"     Pulmonary contusion (PC) is a significant problem after blunt trauma that may often lead to     acute respiratory distress syndrome (ARDS) and in some patients, death. Although the     pathophysiology is incompletely understood, it is clear that there is a biochemical process     involving changes in the inflammatory milieu after contusion which occurs in addition to     simple direct mechanical injury to the lung. The relationship of severity of contusion on     imaging, disturbances in the inflammatory phenotype, and outcome is unknown. This is a     prospective, observational study which will evaluate the size and severity of contusion as     measured on chest computed tomography (CT). Inflammatory mediators will be measured in the     bronchoalveolar lavage (BAL) and in the serum of patients with pulmonary contusion to define     the inflammatory nature of the post-contusion lung. The degree of abnormality within the     inflammatory parameters will be correlated with lung contusion size and subsequent patient     outcomes. These data will be compared to other patient groups: 1) Trauma patients without     chest injury who are mechanically ventilated; 2) Uninjured patients undergoing elective     surgical procedures that will require intubation and mechanical ventilation; 3) Patients in     the Medical ICU who are mechanically ventilated with acute respiratory failure.      The hypothesis tested within this study is resolution of lung injury is dependent upon the     presence of Tregs in the alveolar space.   "
78173|NCT02262650|"     Study to investigate the relative bioavailability of concomitant administration of     clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone     (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to     investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes     after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone     (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)   "
77978|NCT02265185|"     Childhood obesity is a major area of concern for health care and public health. Overweight     children are more likely overweight and obese adults. Chronic health problems associated with     adult obesity are now occurring more frequently in children. Because of the associated health     problems and potential for long term struggles with obesity, intervention early in life is     essential for addressing the obesity epidemic. Some intervention work in this area has     focused on the pediatric primary care setting in order to utilize the influence and     credibility of medical providers. Unfortunately, primary care visits are often too short to     spend a significant amount of time on issues of diet, weight and nutrition.      There has been very little work exploring the potential of alternative care settings, such as     the pediatric Emergency Department (ED) in addressing childhood obesity. While provider time     is also limited in the ED, there is often a considerable amount of downtime during emergency     department visits that could be valuable time for patient and parent education. There may     also be an opportunity to reach parents and children in the ED who do not regularly utilize     primary care. In order to explore the possibility of pediatric obesity interventions in     Children's Pediatric Emergency Department, we will need to measure the prevalence of obesity     in the population that utilizes the Children's ED. The height of patients seen in the ED is     not routinely measured, which makes calculating BMI to determine obesity impossible. This     study, establishing the prevalence of obesity in Children's Emergency Department will lay the     groundwork for future work addressing obesity in the ED.   "
77979|NCT02265172|"     Many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic     surgeon, however, a relatively low percentage of these patients are considered suitable for     orthopaedic intervention.      Physiotherapists are suitable for musculoskeletal assessments and are used as such in many     countries i.e. Advanced Practice Physiotherapists or Extended Scope Physiotherapists,     however, this is not an existing model of care in Sweden. To be able to consider this model     for implementation in Sweden it is necessary to evaluate it from a healthcare as well as from     a patient perspective.      The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic     manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic     surgeon bring any changes to referral routines, patient satisfaction and health-related     variables when compared to standard practice.   "
77980|NCT02265159|"     The investigators aim to evaluate cancer control, genitourinary, rectal and overall     health-related quality of life outcomes and effectiveness of focal therapy for localised     prostate cancer using High Intensity Focused Ultrasound (HIFU).   "
77981|NCT02265146|"     This is a multi-center, investigator initiated study that will prospectively examine     treatment strategies and outcomes of patients who underwent clinically-indicated Near     Infrared Spectroscopy (NIRS). The information collected will be used to determine the     frequency of NIRS imaging performed at the participating sites and to examine the clinical     outcomes of the NIRS-detected Lipid Core Plaques (LCPs).   "
77991|NCT02265016|"     The aim of this study is measurement of expression and activity of RBC eNOS in different     clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to     investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG.   "
77992|NCT02265003|"     The aim of this study is to find out, how far red blood cells reflect age-depended changes in     endothelial function.   "
77982|NCT02265133|"     This study is a prospective, single center clinical trial to assess corneal sensitivity and     nerve fiber morphology in patients with sleep apnea compared to normal controls. Healthy     volunteers with no history of ocular or uncontrollable systemic disease will be encouraged to     participate in the study. After execution and review of the consenting procedures, a detailed     history will be taken and a slit lamp examination performed, verifying ocular health. This     consists of an examination of both eyes including assessments of ocular lids, lashes, cornea     and conjunctival evaluation. Corneal touch thresholds will be tested with a Cochet-Bonnet     aesthesiometer, a standard non-invasive measure of corneal sensitivity. Corneal nerves will     be imaged using a modified HRT in vivo confocal microscope. The in vivo confocal microscope     allows for high resolution imaging of the nerve plexus under the corneal epithelium. This     corneal nerve plexus is responsible for corneal sensitively and changes or loss have been     established as an early, sensitive indicator of corneal neuropathy. The investigators     anticipate that this study will require approximately 30 patients for each group and will     last approximately 12 months for recruitment and completion of subject visit phases. There is     only one clinical visit designed for this project, unscheduled visits may be scheduled in     case of an adverse event.      Patient recruitment will be complete at the one-year time point. At the 14 month time point,     all data points will have been collected and assessment of the outcome measure (corneal     sensitivity in sleep apnea patients versus control patients) will be complete.   "
77983|NCT02265120|"     Significant developments have led to a dramatic change in recommendations for cervical cancer     screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100%     of cervical cancer cases and the development of new technologies for detection of HPV DNA at     time of cervical cancer screening, has produced changes in preventive healthcare policy for     this condition. In an unprecedented event, the American College of Obstetrics and Gynecology,     the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic     and unified changes in screening utilizing this new framework. No studies of significance     have evaluated (since guideline change in 2013), whether primary care providers find the new     recommendations authoritative and believe in them, or whether providers understand     implementation of these new guidelines given the many decades of contradictory and differing     recommendations. For this study, the opinions of primary care providers who care for patients     in the 194 federally designated regions of Primary Care provider shortage within California     will be studied. Using the California Medical Board database of licensed providers, a     questionnaire will be mailed to a random subset. It is anticipated that the analysis will     show varying contempt, confusion and compliance with new guidelines exists. Understanding     these factors will have beneficial health policy implications in terms of overcoming barriers     to these cost-effective, less intrusive, and more accurate health policy guidelines in the     prevention and early detection of cervical cancer.   "
78174|NCT02262637|"     Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual     daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the     clientele of cardiologists, nephrologists, and diabetologists   "
77984|NCT02265107|"     Objective: To observe the effects of exercise training on vascular endothelial function in     patients undergoing coronary artery bypass graft (CABG) alone in phase III after six months     of Cardiac rehabilitation programs (CRP).      Methods: the investigators contacted all patients undergoing CABG alone in period of 1 year     to participate in a CRP with duration of six months with three weekly sessions of 1 and half     hour of the duration. All patients underwent biochemical blood tests, muscle strength testing     of one repetition maximum (1-RM test) for upper and lower limbs, 6-minute walk test (6MWT),     and evaluation of endothelial function (using flow-mediated vasodilation).   "
77985|NCT02265094|"     The aim of this study is to investigate the neural substrates of associative memory in Autism     Spectrum Disorder using both behavioural and EEG assessments.   "
77986|NCT02265081|"     The proposed study is to evaluate if there are specific factors in the pelvic floor     functional anatomy which can predict the ability of having a vaginal birth after caesarean     section.      Physical characteristics of the soft tissue in the female pelvis play an important role in     successful vaginal delivery. A tight or less distensible pelvic floor muscles may influence     mode of delivery, leading to poor labour progression and by compressing foetal head produce     CTG abnormality such as decelerations, both resulting in caesarean delivery.      One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the     passage of fetal head through the birth canal by stretching and distending. Therefore     distensibility of the female pelvic floor influences mode of delivery.      Three hundred patients, in the third trimester of pregnancy, will be recruited via the     antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible     participants are pregnant women who had either one or no vaginal births, or one caesarean     section and who can give an informed consent and maintain their autonomy regarding mode of     delivery with understanding of the forthcoming study results. Participants will be excluded     if they sustain any obstetric complications that may impede on time and mode of delivery     including an emergency prelabour caesarean section.      Ultrasonographic assessment of the differences in the pelvic characteristics of these women     will be used to predict a successful of trial of vaginal delivery after caesarean section     (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is     a simple (single ultrasound assessment) that can be used to help inform women's choice     regarding mode of delivery.      Results from this research could be a pioneering blueprint for further studies, as there is     very little known about this topic.   "
77987|NCT02265068|"     Documentation of long-term data regarding ticagrelor use and evaluation of reasons for     discontinuation of ticagrelor in patients with ACS   "
77988|NCT02265055|"     To observe whether Number of early cleavage embryos can be a predictor for multiple     pregnancies after ICSI.   "
77989|NCT02265042|"     The aim of the study is to investigate whether there is an effect of electrical stimulation     on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury.     The expected outcome is an increase in muscle volume and a better pressure distribution     during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over     a period of six months. The muscle volume and the pressure distribution are measured before     stimulation, three months after having started stimulation and after six months.   "
77990|NCT02265029|"     Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive     to touch). The pain and tenderness tend to come and go, and move about the body. There is no     cure for fibromyalgia. Complementary and alternative therapy such as acupuncture,     chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of     these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect     3 to 4% of the general population and 14 % of patients with rheumatologic disease.     Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle     adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of     quality of life.      Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of     spa therapy in rheumatologia on evolution of disability in daily life of patients with     fibromyalgia.   "
77993|NCT02264990|"     This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus     carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in     current or former smokers who are receiving their first cytotoxic therapy for metastatic or     advanced non-squamous non-small cell lung cancer.   "
77994|NCT02264977|"     The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic     Branch Endoprosthesis to treat aneurysms involving the aortic arch   "
77995|NCT02264964|"     The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be     investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal     failure requiring hemodialysis will be enrolled. 900 patients will be given right internal     jugular catheterization, and the other 500 patients unsuitable for right internal jugular     catheterization will receive femoral catheterizations. Every patient will be followed-up for     six months. During following-up period, the duration time and adverse events of non-cuffed     catheter will be recorded in details, including inadequate hemodialysis blood flow, venous     stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will     be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This     multicentre trial will provide evidence to develop guideline for duration time of using     non-cuffed catheter.   "
77996|NCT02264951|"     This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of     20 ml olive oil on a molar basis in human volunteers.   "
77997|NCT02264938|"     Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related     macular degeneration (AMD) after one year of oral supplementation with AREDS-like     formulation.   "
77998|NCT02264925|"     The objective of this study is to characterize through spectral analysis intra-thalamic local     field potentials (LFPs) recorded through implanted DBS leads during periods with and without     tremor in patients suffering from severe essential tremor.   "
77999|NCT02264912|"     The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry     was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who     underwent intracoronary stent implantation, have been included regardless of whether     percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients     were included in the registry after having signed an informed consent for participation. No     exclusion criterion has been applied for the registry participation. Efficacy of P2Y12     receptor antagonists has been measured by quantitative flow cytometric analysis of     vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer     protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow     cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months     and one year follow up has been investigated.   "
78001|NCT02264886|"     The purpose of this research study is evaluate whether it's feasible to give radiation     therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy     involves the adjustment or re-planning of treatment day by day while the participant is     receiving treatment. The adaptive technique has previously been used in a different fashion     to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment     while the participant is still on the table is a new way of using the adaptive technique.     This may allow doctors to use more radiation to treat the tumor while better protecting     normal tissues. A special radiation treatment machine incorporates both an MRI scanner and     radiation treatment devices so that the planning and treatment can be done using the same     machine.   "
78002|NCT02264873|"     Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in     Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on     the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT)     in patients with leukemia will enhance disease control by the allogeneic immune system and     lead to a longer disease free survival. The study is designed to provide safety data of     low-dosing in the post-transplant setting.   "
78003|NCT02264860|"     HIV infection causes systemic zinc deficiency and oxidative stress that impairs host immunity     in the alveolar space.The purpose of this study is to see if taking two nutritional     supplements, zinc and SAMe (S-adenosylmethionine), can improve lung health and immune     function in persons with HIV.      The investigators hypothesize that long-term dietary supplementation with zinc and the     glutathione precursor SAMe will enhance pulmonary host immune function in HIV-infected     individuals who do not respond adequately to ART alone.   "
78004|NCT02264847|"     In women being treated with medicines to help eggs to grow (called ovulation induction), The     investigators wish to know whether adding medicines (called ovulation triggers) that help to     release the egg (ovulation) would lead to more women having babies without causing harm     compared with not giving them ovulation triggers.   "
78005|NCT02264834|"     Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the     concentration of local anesthetic and therefore the motor block.   "
78006|NCT02264821|"     The aim of this study is to compare effective analgesia with continuous wound infiltration of     ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to     spinal anesthesia, after elective Caesarean delivery.   "
78007|NCT02264808|"     Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and     in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits     and/or death at 18-20 months.   "
78019|NCT02264652|"     High-Definition transcranial Direct Current Stimulation (HD tDCS)      Genuine cathodal HD-tDCS will be delivered through High-Definition electrodes that will be     arranged on the skull according to a 4x1-ring configuration with the central cathodal     electrode placed over the identified target and surrounding return electrodes forming     approximately a 5-cm radius ring.      Aim: To explore whether a novel form of tDCS can be a safe noninvasive treatment that could     potentially suppress seizures in refractory partial-onset epilepsy.   "
78020|NCT02264639|"     This study will be the initial exploration of APL-2 in patients with PNH. The assessments of     the safety, tolerability, PK, and PD following administration of single and multiples doses     of APL-2 will guide decisions to further develop the drug.   "
78008|NCT02264795|"     The instillation of local anesthetic into the peritoneum has been found to be safe and     effective in reducing postoperative pain and morphine consumption after abdominal surgery. A     review of studies reporting serum levels of local anesthetic after intraperitoneal delivery     found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis     did not include post-cesarean delivery pain and there is a lack of data to support the use of     intraperitoneal local anesthetic after cesarean section.      The purpose of this study is to assess the efficacy of intraperitoneal lidocaine on     postoperative pain scores after cesarean delivery. This study will compare a 20ml solution of     lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into the     peritoneum at the end of surgery in women undergoing cesarean delivery. The investigators     hypothesize that intraperitoneal lidocaine will result in lower pain scores, reduce opioid     consumption and opioid related side effects, and higher maternal satisfaction after cesarean     delivery.   "
78009|NCT02264782|"     PreView is a novel tool that functions within the system in a busy clinic setting, integrates     information obtained from a particular patient with provider alerts, is efficient, relieves     the burden of time constraints and is tailored to the individual patient. The goal of PreView     is to support and simplify the physician's role in promoting cancer screening.   "
78010|NCT02264769|"     PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the     most commonly used uterotonic drug to prevent and treat PPH in North America. However     oxytocin has a very short duration of action, requiring a continuous infusion to achieve     sustained uterotonic activity. Moreover large doses are associated with adverse effects like     hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and     Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at     elective cesarean delivery to promote uterine contraction. In three studies recently     performed at Mount Sinai Hospital, the investigators have found no difference in uterine     contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus     a larger trial comparing the minimum effective dose determined in the previous three trials     with the standard 100 mcg dose is necessary to confirm these findings.   "
78039|NCT02264392|"     Standard treatment for a soft tissue abscess involves incision over the area of maximum     fluctuance with drainage of purulence from the abscess cavity. The use of bedside ultrasound     to guide this drainage has the potential to improve treatment outcomes by ensuring complete     drainage of the cavity.      Our hypothesis is that the use of ultrasound for guidance of incision and drainage of soft     tissue abscesses will decrease treatment failure rate compared to standard blind incision and     drainage.      This hypothesis will be tested utilizing a blinded, randomized trial comparing standard     incision and drainage to ultrasound guided incision and drainage.   "
78040|NCT02264379|"     The purpose of this study is to evaluate the outcomes of patients treated with an high dose     radiation regimen using either stereotactic hypofractionated or normofractionated     radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a     desired result or effect) and safety in this setting.   "
78011|NCT02264756|"     The purpose of the study is to determine whether an antimicrobial stewardship program can     decrease the length of hospital stay for patients with pneumonia. The antimicrobial     stewardship program is run by a pharmacist and doctor with extensive training in managing     infectious diseases. These two health care professionals are responsible for reviewing the     records of patients admitted to hospital with pneumonia, and then making specific     recommendations to the patient's attending physician about how to manage antibiotic     treatment. These recommendations might include discontinuing the antibiotic, or changing the     way antibiotics are delivered from intravenous form to pill form, among many other potential     options. The attending physician considers whether these recommendations should be followed     or rejected. The study has a control group of patients who are not reviewed by the     antimicrobial stewardship team, and their length of hospital stay will be compared to the     reviewed group of patients. Any differences between these two groups will be assumed to be     due to the impact of the antimicrobial stewardship program. So far, no previous study has     been able to demonstrate that an antimicrobial stewardship program can reduce the length of     stay of patients admitted to hospital with pneumonia. This study has some important     differences from previous studies that may make its conclusions more accurately reflect the     true impact of antimicrobial stewardship programs. The most important difference is how the     timing of the review is modelled in the analysis of the study results. Because the timing of     the review varies between patients, with some patients being reviewed at earlier and some at     later times, this subtle difference, if not accounted for in the analysis, can mask a true     positive effect of the program on length of stay. The investigators study will account for     this variation.   "
78012|NCT02264743|"     Ultra-low-dose oral E2/D will have more beneficial effects than trans-dermal HRT on lipids     and insulin resistance in postmenopausal women, whilst adverse effects on coagulation will be     avoided.   "
78013|NCT02264730|"     Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery     in Which Liver Bleeding is Encountered.   "
78014|NCT02264717|"     1. The primary purpose of this study is to determine the diagnostic accuracy of the CADscore     System, a new danish technology that records sounds from turbulence of bloodflow in the     coronary vessels.      And secondary:        1. To determine the accuracy of cardiac magnetic resonance imaging (MRI) and single-photon          emission computed tomography (SPECT), as secondary tests after detection of obstructive          anatomic coronary artery stenosis by coronary computed tomographic angiography (CCTA).        2. To examine the patient population for bio-genetic markers related to development of          arteriosclerosis.        3. To evaluate virtual fractional flow reserve (vFFR) computed from coronary angiograms.   "
78015|NCT02264704|"     This study aims to determine the effect of exercise intensity within a 15 week programme in     moderately disabled people with multiple sclerosis (MS). Although earlier research has shown     that exercise is safe and may improve health related factors such as mobility and fatigue,     the intensity at which exercise offers the most benefit has not yet been defined.      Participants will be randomly assigned to one of three groups - high intensity, moderate     intensity or usual care. Participants in the exercising groups (high and moderate intensity)     will take part in a supervised 15 week cycling exercise programme based in the Douglas Grant     Rehabilitation Centre. Those assigned to the usual care (control) group will continue to     receive their usual medical care and will not participate in the exercise programme. The     acute immune response to exercise will also be measured.      Participants from all three groups will be monitored regularly. Clinical outcomes of the     study include immunological markers, exercise capacity, mobility, fatigue, quality of life     and cognitive ability. These will be measured by a combination of blood tests, physical     assessments and questionnaires.      It is hypothesised that high intensity exercise will cause a favourable, anti-inflammatory     response which will be associated with greater improvements in physical and psychological     outcomes than both moderate intensity exercise and usual care.   "
78016|NCT02264691|"     To identify and understand biologic aspects of severe asthma compared to subjects with mild     to moderate asthma and subjects without asthma (normal or healthy volunteers).   "
78017|NCT02264678|"     This is a modular, phase I/ phase 1 b, open-label, multicentre study of AZD6738 administered     orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents,     to patients with advanced malignancies. The study design allows an investigation of optimal     combination dose of AZD6738 with other anti-cancer treatments, with intensive safety     monitoring to ensure the safety of the patients. The initial combination to be investigated     is AZD6738 with carboplatin. The second combination to be investigated is AZD6738 with     Olaparib. The third combination to be investigated is AZD6738 with MEDI4736.   "
78018|NCT02264665|"     A descriptive, prospective (partly retrospective), multisite, observational study conducted     in France in adult patients treated for a well differentiated, unresectable or metastatic,     pancreatic neuroendocrine tumor with disease progression.   "
78021|NCT02264626|"     In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason     of failure.      This may result in a poor synchrony between the patient and the machine, leading to gross     mismatching and potentially to an increased work of breathing.      The investigators aim to investigate whether in these patients poorly responding to NIV the     use of a sedation protocol using remifentanil will lead to an improve patient-ventilator     interaction and better compliance to NIV.   "
78022|NCT02264613|"     This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid     tumors or lymphomas with WT TP53.   "
78023|NCT02264600|"     The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease     (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been     reported in recent studies. Increased oxidative stress is thought to play an important role     in cardiovascular complications of WED patients. Apelin is a novel described antioxidant     bioactive peptide. The investigators hypothesize that patients with WED have lower plasma     apelin level than healthy subjects based on presence of oxidative stress of WED.   "
78024|NCT02264587|"     The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on     diabetic gastroparesi.   "
78025|NCT02264574|"     An open-label, multi-center randomized, phase 3 study of ibrutinib combined with obinutuzumab     versus Chlorambucil in combination with obinutuzumab in subjects with treatment-naïve Chronic     Lymphocytic Leukemia or Small Lymphocytic Lymphoma.   "
78026|NCT02264561|"     The purpose of this study is to determine whether caffeine improves attention.   "
78027|NCT02264548|"     -  evaluate the safety and toxicity profile of renal radio-ablation in the setting of          metastatic renal cell carcinoma.        -  to assess renal function post radio-ablation        -  Primary and metastatic tumour response to radio-ablation   "
78028|NCT02264535|"     This pilot study is designed to explore the optimal concentration and method of Ginkgolides     Meglumine Injection skin testing and to evaluate the value of skin test in predicting any     possible allergic reactions to Ginkgolides Meglumine Injection.   "
78029|NCT02264522|"     The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide     the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to     further the investigators understanding of homeostasis in hemodialysis.      The investigators hypothesize that the signals generated from the PPG device along with     traditional monitoring and nursing judgment, will allow experienced, oriented staff to     anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic     hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that     preclude the patient from achieving an appropriate post-dialysis weight consistent with     euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to     wean patients from anti-hypertensive medications and craft patient specific dialysis orders     and UF profiles that achieve consistent, comfortable treatment to appropriate end points.      The study aims include:      Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine     hemodialysis.      Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac     event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to     reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.      Aim 4: To develop care paths approved by the medical staff and primary care nephrologist     allowing RNs to respond to signals from the PPG.   "
78030|NCT02264509|"     The purpose of this study is to determine the risk factors associated with the occurrence of     arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this     disease. The estimated prevalence is 10%, similar to that reported in the general population.   "
78031|NCT02264496|"     Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the     mainstay of curative therapy. With the screening program enabling early detection, surgery     plays an important role in treatment strategies. Surgery imparts a significant physiological     and psychological stress on cancer patients.Recent research has demonstrated that a     fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake     can improve outcomes by reducing the physiological stress response to surgery. The primary     objective of this study is to determine whether a defined exercise programme can improve     recovery and reduce complications after surgery.   "
78032|NCT02264483|"     * Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary     Disease) exacerbations which could be demonstrated by performing low-dose chest CT.     Differences in the inflammatory profile in sputum and blood in patients with and without     pneumonia can be seen.      * Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using     chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum     between patients with and without pneumonia.      *Material and Methods: Prospective observational study including 75 patients with the     diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract     infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray     and chest low-dose CT are performed. The investigators divide the patients into two groups     according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory     markers) and sputum (cell populations and inflammatory markers) is compared between the two     branches.   "
78033|NCT02264470|"     Falls after stroke are common. Previous research has shown that almost every other, 48%, of     patients with a first-ever stroke fell at least once during the first year after stroke (1).     Moreover, most of the patients fell during the first three months after stroke onset.     However, the exact time-point for the falls was not analyzed (1). In addition, many patients     are falling already during hospital stay (2-5). Reducing the number of falls during inpatient     rehabilitation on a stroke unit is a high-priority mission. Greater knowledge concerning the     factors that best predict falls is eligible.      The aim of the study is to analyze the significance of different physiological, psychological     and medical factors for predicting the risk of falling in patients with stroke per day of     care at a stroke unit.   "
78055|NCT02264184|"     Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose     pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability   "
78056|NCT02264171|"     Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose     pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability   "
78034|NCT02264457|"     During cataract surgery an artificial lens is implanted in the eye. These artificial lenses     are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your     eyes have astigmatism, which is a normal and common characteristic of the eye. If left     uncorrected the astigmatism would mean that you would need to wear spectacles for viewing     distance objects. New IOL designs called toric IOLs help to correct the astigmatism to     improve your vision after cataract surgery. This study has been designed to look at how well     a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing     distance objects. There are many designs of these toric IOLs and for this study we are     looking to compare two different designs of toric IOLs by putting one lens in your right eye     and a different type of lens in your left eye. Both lenses are commercially available and are     commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge     the visual performance of these lenses and the ability of these lenses to correct     astigmatism. In addition the study will involve imaging and examining the IOLs to determine     the prevalence of any post-operative complications.   "
78035|NCT02264444|"     Essential to laparoscopic operations is adequate visualization. Unfortunately there is no     grading system to assess the degree or quality of visualization. The primary objective of the     project is to develop a laparoscopic visualization scoring system. We also intend to     investigate the effects of neuromuscular blockade agents on visualization.   "
78036|NCT02264431|"     The main objective of the study is to identify the determinant of sleep characteristics of     obese patients attempting a tertiary clinical center for obesity management, including     bariatric surgery.      More accurately the questions addressed are:        -  What are the determinants of the sleep habits (sleep duration, chronotype) and of their          evolution        -  What are the determinants of sleep breathing disorders (sleep apnea, obesity          hypoventilation syndrome) and of their evolution   "
78037|NCT02264418|"     The purpose of this first-in-human study is to evaluate the safety and tolerability of     escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the     maximum tolerated dose and dose limiting toxicities.   "
78041|NCT02264366|"     The ACCELERATION (ACtivity, smoking Cessation, healthy Eating and aLcohol Education,     inteRvention, and motivATION) Program is a collaborative project in cancer and chronic     disease prevention that has been designed by and will be delivered amongst cardiopulmonary     rehabilitation and prevention programs and cancer centres in Ontario (ON), British Columbia     (BC), Quebec (QC) and Nova Scotia (NS). This project is being funded by the Canadian     Partnership Against Cancer, Health Canada and Heart and Stroke Foundation of Canada and in     the amount of $2.4M over a 3 year period (October 2013 - September 2016). The ACCELERATION     Program is a 12 week structured model of behavioural interventions and education around     self-management and prevention that aims to access readily available and referable people for     primary prevention intervention.This program aligns with current provincial, national and     international chronic disease prevention and management strategies. The goal of the     ACCELERATION program is to measurably and effectively change the risk factors and health     behaviours known to impact cancer and other chronic diseases. Specifically we will aim to     increase physical activity, reduce smoking, encourage healthy eating, and moderate alcohol     consumption in about 3,000 participants across Canada over 3 years.   "
78042|NCT02264353|"     The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low     arousal threshold may wake up too early during a respiratory event, before upper airway     muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the     respiratory arousal threshold could potentially improve the quality of sleep and sleep     disordered breathing. Agents that raise arousal threshold are therefore likely to benefit     some patients with OSA. The overall goal of this project is to determine the importance of     the arousal threshold in OSA, determine which patients might benefit from a raised arousal     threshold, and test this hypothesis by using pharmacological manipulation of the arousal     threshold to achieve this goal.   "
78043|NCT02264340|"     Tension headache is a common disabling disease and a worldwide public health problem. This     research tries to demonstrate the efficacy of physical therapy, based on cervical training     and postural self-correction instructions, which aims to increase the positive results     obtained from traditional relaxation techniques (Schultz Autogenic Training). University     students are selected, because headaches are very common in this sector of the population.     The design is a non-pharmacological randomized controlled trial, with blinded evaluation of     the response variables. The investigators compare two independent samples. One of them     receives an only treatment (Autogenic Training) and the other group receives a combined     program (Autogenic Training + specific cervical exercises and postural correction). Pain     parameters (frequency, intensity and duration) and drug consumption are measured before     treatment, and then, at 4 weeks and 3 months, to value the results.   "
78057|NCT02264158|"     Assessment of the influence of telmisartan, lacidipine and their combination on the QTC     interval of the ECG   "
81899|NCT02213978|"     The purpose of this study is to analyze the effect of the prophylaxis of venous     thromboembolism in the critical ill patients, and at the same time, to find out the risk of     venous thromboembolism and hemorrhage events occurred under the prophylaxis.   "
78044|NCT02264327|"     Clinical social workers, doctors, outreach workers, and all other staff providing direct care     to vulnerable populations face multiple challenges in obtaining and maintaining training and     implementing evidence based practices in diverse community settings. Motivational     Interviewing is a well-established evidence based practice that is challenging to implement     across programs and agencies because it requires that skills gained from training be     reinforced as a service provider employs the practice.      This study builds on findings from a Phase I study. With funding from a Phase I Small     Business Innovation Research grant from the National Institute of Health, the Center for     Social Innovation developed the Motivational Interviewing Simulator: An Experiential Online     Training Tool. The interactive, case-based, multiplayer web-based game allows service     providers to deepen their skills in Motivational Interviewing (MI), a widely recognized     evidence-based practice that supports people to make positive behavior changes related to     health, wellness, mental illness, and addiction.      The Phase II randomized controlled trial's primary aim is to assess the relative     effectiveness of three interventions (MI Training Only; MI Training + eBook; MI Training +     SIM) in increasing provider MI knowledge and skill retention over time.      During Phase II of this study, we will recruit 180 providers from 18 community agencies     serving individuals who live in supportive housing, many of whom have histories of mental     illness, addiction, homelessness, and medical problems. After receiving a standardized     two-day onsite MI training, participants will be randomized into one of three conditions: 1)     MI Training Only; 2) MI Training + eBook (an online comparison with comparable information to     the Simulator without the interactive elements); or 3) MI Training + Simulator. The     longitudinal, mixed methods study will assess providers' acquisition and retention of MI     knowledge and skills through surveys and coding of standardized client interviews; barriers     and facilitators of MI implementation via focus groups; organizational-level data via key     informant interviews and site visits; and client outcomes for 3,600 clients through surveys,     administrative, data and focus groups.   "
78045|NCT02264314|"     Hearing loss is the third most common chronic condition in over 65 years people, it is     estimated that 77.8% of older adults suffer from it. However, there are reports of adherence     to the use of hearing aids of only to 40%. The objective of this project is to measure the     effectiveness of a tele-educative intervention to improve adherence to the use of hearing     aids. A randomized controlled trial was performed. The active branch consists of the     implementation of an educational program called Active Communication Education, consisting of     4 sessions with a trained rehabilitator. Participants will be also monitored by telephone     headset use by personnel trained for three months. The control arm will consist of the usual     care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12     months after randomization.   "
78046|NCT02264301|"     The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin     injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.   "
78048|NCT02264275|"     The purpose of this study is to determine if aerobic exercise training can serve as     comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating     depressive symptoms and augmenting sleep while bolstering health related quality of life in     youth with Crohn's Disease and Ulcerative Colitis.   "
78072|NCT02263963|"     The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus     abdominis plane block by assessing the demand of postoperative narcotic, length of hospital     stay and incidence of postoperative complications.   "
78175|NCT02262624|"     To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs.     its monocomponents   "
78176|NCT02262611|"     Study to obtain long-term data on effects, safety and tolerability in routine medical     practice and to investigate the potential of telmisartan to prevent secondary organ damage   "
78177|NCT02262598|"     To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ     vs. its monocomponents   "
78049|NCT02264262|"     Activation of the sympathetic nervous system is associated with increased risk of ventricular     arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable     tools to measure sympathetic outflow in human subjects is therefore highly desirable.      Microneurography is the current gold standard measurement technique, whereby multiunit     postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes     inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is     considered extremely safe, and has been used successfully for decades in human translational     physiology experiments, it has not been adopted for routine clinical assessment due to the     requirement for sophisticated equipment and specific technical training and skills.     Alternatively, many have adopted heart rate variability as a simple, noninvasive technique     for assessing sympathetic nerve activity. However, heart rate variability does not directly     measure sympathetic nerve activity, and there is much debate in the literature as to the     exact source of sympathetic nerve traffic. For example, many believe it is an accurate     reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in     muscle or skin sympathetic nerve activity.      To address these limitations, the investigators have developed a simple, noninvasive     technique to measure sympathetic nerve activity using surface electrodes.      Despite its great promise, this new approach has not yet been directly validated. The purpose     of this study is therefore to validate this new technique (refered to as EKG-NA) against the     current gold standard measurement technique, microneurography.   "
78050|NCT02264249|"     The purpose of this study is to determine residual gastric volume and residual gastric pH in     patients undergoing combined EGD and colonoscopy comparing the standard single dose prep with     the split dose bowel preparation and same day bowel preparations.   "
78051|NCT02264236|"     The purpose of this study is to evaluate the clinical efficacy of an investigational agent,     P10s-PADRE, a peptide mimotope-based vaccine, in patients of all races with stage IV     Non-Small Cell Lung Cancer who have completed their primary chemotherapy without progressing,     and who still have measurable residual disease.      A randomized double-blind placebo-controlled trial is designed with the goal being to     evaluate the efficacy of the vaccine. Efficacy will be based primarily on the tumor response,     and secondarily on progression-free survival. Information on safety and tolerability will be     collected. Humoral and cellular immune responses will be analyzed.   "
78052|NCT02264223|"     Previous literature has shown that the molecular form of isoflavones (as aglycones or     glycosides) and food matrices can influence the bioavailability of these compounds in humans     and hence their efficacy. To determine the effects of processing and food matrices on the     bioavailability of active compounds derived from red clover the investigators will execute a     5 phase, cross-over design, open label, RCT using 20 healthy women aged between 18 to 40     years. Participants will receive 5 different formulations of red clover and bioavailability     will be monitored in blood plasma using LC-MS.   "
78053|NCT02264210|"     This phase II trial studies how well icotinib works in treating patients with completely     resected stage IB NSCLC harboring EGFR mutation.   "
78054|NCT02264197|"     Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food     on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety   "
78058|NCT02264145|"     The study objective is to determine the effect of the ethanolic solutions inhaled from the     Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4     of ethanol) on the breath alcohol measurements in healthy volunteers.      Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open,     randomized, four-way-cross-over design is chosen. The randomization is balanced and     stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)   "
78059|NCT02264132|"     The objectives of this study were to investigate relative BA at steady state and to     investigate dose proportionality of pharmacokinetic parameters      Relative BA at steady state:        -  Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.        -  Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.      Dose proportionality of pharmacokinetic parameters:      · Pramipexole ER dosages from 0.375 to 1.5 mg q.d.   "
78060|NCT02264119|"     Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under     physiological conditions and with 40 mg Pantoprazole   "
78061|NCT02264106|"     To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological     conditions and with 40 mg Pantoprazole   "
78062|NCT02264093|"     To investigate the effects on airway lumen of talsaclidine in combination with propranolol     and of talsaclidine and propranolol given as monosubstances   "
78063|NCT02264080|"     Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a     multiple dose to healthy adult male volunteers in double blind manner.   "
78064|NCT02264067|"     To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single     dose to healthy adult male volunteers in double blind manner.   "
78065|NCT02264054|"     Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.   "
78066|NCT02264041|"     Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the     single dose pharmacokinetics of cilobradine   "
78067|NCT02264028|"     -  To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and          intravenous administration in healthy volunteers        -  To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous          administration to healthy volunteers   "
78068|NCT02264015|"     Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT     analysis of ECGs), and pharmacokinetic parameters   "
78069|NCT02264002|"     Pharmacodynamic effects on heart rate (HR) at rest and during exercise and on flicker fusion     frequency (FFF), FFF method evaluation      Safety, tolerability and pharmacokinetics of cilobradine   "
78070|NCT02263989|"     Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the     conventional 40 mg telmisartan tablet   "
78071|NCT02263976|"     Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics     (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide     is able to protect of methacholine-induced bronchoconstriction compared to baseline     (methacholine challenge at screening).   "
78073|NCT02263950|"     This clinical trial will assess whether a medicine called artemether, currently used at a     lower dose to treat malaria, could also be useful in treating cancer. For this trial, the     medicine is given in a new way, as a spray under the tongue. This delivery has several     advantages, including better absorption into the body and it may be easier for people to     take. It will be prescribed to consenting patients with advanced solid tumours, every day for     4 months, either once or twice a day. (For this study 'advanced tumour' will mean there are     no other effective standard therapy options available to the patient).      The dose will be decided in Phase 1 of the study by initially testing 3 different doses of     the medicine in up to 21 different cancer patients, to make sure it is not too toxic or     causes any side effects.      After this, the highest safe dose identified in the first phase will be tested in up to 66     cancer patients in Phase 2 of the study, to see if the medicine is able to reduce the size of     their tumour or slow down its growth.   "
78074|NCT02263937|"     This trial aims to collect pilot data to explore whether bilateral deep brain stimulation     (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking     impairments among individuals with Dementia with Lewy Bodies (DLB).   "
78075|NCT02263924|"     Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial     to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in     patients with moderate ischemic stroke.      150 patients will be recruited. Half will receive mixed tocotrienol 200mg twice a day for 6     months while the other half will receive placebo capsules.   "
78076|NCT02263911|"     The purpose of this study is to understand the relationship of 3 different dosage forms of     baricitinib. This study will also explore the effect of food on how the body absorbs     baricitinib. This study will last about 5 weeks, not including screening. Screening is     required within 28 days prior to the date of first dosing.   "
78077|NCT02263898|"     This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and     MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to     other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may     stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving     LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time     when tumors become resistant to the drugs.   "
78078|NCT02263885|"     The proposed study will evaluate the safety, and initial efficacy of using the ExAblate     Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD     medications in subjects who are over 30 years of age and considered medication-refractory     with advanced idiopathic Parkinson's disease (PD).   "
78091|NCT02263716|"     This study is to determine whether accelerometry can be used to measure physical activity     occurring during routine clinical care in a diverse population of patients with medical or     surgical critical illness.   "
78079|NCT02263872|"     In this double blind randomised controlled pilot trial the investigators aim to determine the     efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive     disorder. The investigators hypothesize that the multiple neuroprotective effects of     minocycline will lead to an improvement in depressive symptoms in participants that were     given minocycline plus treatment as usual   "
78080|NCT02263859|"     The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve     stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for     individuals with moderate to severe OSA that have failed or do not tolerate PAP.   "
78081|NCT02263846|"     This study is to investigate sex hormones levels of Chinese patients with invasive breast     cancer.The aim is to analyze biochemical monitoring results of premenopausal and     postmenopausal patients to facilitate determination of menopausal status and propose clinical     application.   "
78082|NCT02263833|"     This national study was a post-marketing surveillance study conducted in Korea from 29 August     2008 to 28 August 2012 to meet local regulatory requirements for Mircera     (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for     safety/risk assessments and effectiveness. No specific study-related procedures are required.     Participants were to be followed up as long as possible at the physician's discretion.   "
78083|NCT02263820|"     Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common     cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and     post-operative AKI. The development of CI-AKI after cardiac catheterization is associated     with a significant increase in both short-term and long-term mortality and morbidities, as     well as an increase in length of stay and cost.      The only marker of renal function that has predictive ability is creatinine and it has     significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic     test for predicting CI-AKI risk would have widespread clinical utility.      The primary purpose of this study is to measure the association between baseline expression     of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac     catheterization.   "
78084|NCT02263807|"     Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included     into a randomized prospective study. This study addresses two forms of treatment for     recurrent patella dislocation. One group is offered reconstruction of the medial     patellofemoral ligament (MPFL), the second group is offered a standardized training program.     70 patients are evaluated in the study. 75 of those fulfilled the inclusion criteria and are     included in the study currently.   "
78085|NCT02263794|"     Patients in London and Hamilton with severe asthma who are deemed eligible by a respirologist     to undergo bronchial thermoplasty treatment will be randomized to image-guided or     conventional bronchial thermoplasty using hyperpolarized noble gas imaging.   "
78086|NCT02263781|"     Evaluation of PREPL activity in healthy controls and known or possible PREPL deficient     patients   "
78178|NCT02262585|"     Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277     capsule   "
78179|NCT02262572|"     Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations     based on sodium salt compared to the present commercial formulation (MicardisPlus®)   "
78180|NCT02262559|"     Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277     capsule   "
78181|NCT02262546|"     The objective of the study is to assess that pramipexole does not prolong the QT interval     more than placebo   "
78087|NCT02263768|"     Objectives: To assess the effectiveness of two recall intervals on dental caries incidence     (primary outcome) in preschool children with low and moderate caries risk. The level of     anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)     according to each interval will also be assessed. Methods: The sample will consist of 224     children between 3-5 years of age, of both genders, with low and moderate caries risk     according to the clinical criteria adapted from the Secretary of Health of São Paulo.     Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical     examination + orientation for oral health and diet on the recall of 12 months; and Group 2     (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18     months.   "
78088|NCT02263755|"     According to the World Health Organization about 1,400,000 deaths reported annually, are     related to chronic liver disease. Chronic liver disease is very prevalent in South Korea,     placing a large economic burden nationwide. Subsequently, an effective and systematized     approach to managing chronic hepatitis is imperative in Korea.      The natural history of chronic liver disease differs greatly according to race and ethnicity.     However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients.     Therefore, the investigators plan to establish a retrospective and prospective multicenter     cohort for chronic hepatitis B based on Korean patients that may be utilized for various     future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the     establishment and distribution of clinical guidelines for Korean patients with chronic     hepatitis B, as part of a nationwide project supported by the Centers for Disease Control     (CDC), Korea.      The investigators plan to collect 500 cases as have been advised by the CDC during the study     period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past     5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver     fibroscan and liver biopsy from these 4 institutions. The investigators plan to register     available cases retrospectively from those who are available to agree to give written     informed consent to participate in this study, and to register the remaining numbers of cases     prospectively, according to the inclusion and exclusion criteria.   "
78089|NCT02263742|"     This project aims to study health outcomes of individuals with mental illness attending a     co-located primary health care center in a mental health center. This study uses mixed     methods to collect a range of information about who chooses to use what Wellness Center     services and in what combinations, with what short and longer-term effects and with what     outcomes.      Based on participant interviews, identify barriers to and facilitators of access, service,     and improvements in person-centered outcomes and elicit suggestions for enhancing health care     outcomes and choice.      Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to     develop and pilot the effectiveness of a new peer-led community based intervention in     enhancing access and choice and improving person-centered health outcomes.   "
78090|NCT02263729|"     The goal of this study is to determine safety and tolerability of Losartan when used for     treatment of an acute grade II or III hamstring strain and determining the effect of losartan     on recovery of hamstring muscle function. Subjects will be adults age 18-35 with grade 2 or 3     hamstring injury who participate in Level 1 athletics or have a similar physical work load     (e.g. military personnel). Military personnel will only be recruited at Brookings Medical     Institute. Subjects will undergo examination, MRI, and functional assessment before, during,     and after 4 weeks of losartan (50mg QD) or placebo.   "
78092|NCT02263703|"     Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause     of several other cancers and conditions. There are now effective vaccines against the main     oncogenic HPV types, HPV16 and 18.      Most research and discussion has focused on targeting the vaccine to young women and older     adolescents. Based on this, a national free HPV vaccination program for adolescent girls     commenced in 2007, in Australia. However, at the time of commencement, there had been no     research on the use of this vaccine in immunosuppressed. Therefore, information on the     immunogenicity, safety and duration of efficacy of HPV vaccine when administered to     immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent     HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity,     followed for 5 years for duration of immunity.   "
78093|NCT02263690|"     92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups:     proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival lidocaine     (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their pain     experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately following the     injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients also graded     the overall injection experience as Excellent, Very Good, Fair, Poor or Awful. The physician     evaluated the patient's eye movement during intravitreal injection in three levels: none or     minimal (0), not compromising the injection (1), compromising the injection (2).   "
78094|NCT02263677|"     Participants will be persons with type 2 diabetes who are likely to have fatty liver disease.     The investigators think that this medication will reduce fatty liver.      The investigators will use an MRS (a non invasive method using magnets) to evaluate liver fat     before and after subjects take a diabetes medication. The investigators will also collect a     small amount of blood to measure liver, kidney and hormone functions. This will be done 4     times. Also, at the time of the subject gets their first dose of medication they will have a     DEXA (low exposure x-ray often used in clinical practice to measure bone density and body     composition).      The goal of all of these studies is to determine whether the study drug lowers liver fat.   "
78118|NCT02263365|"     Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced     by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and     familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or     other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may     potentially have a delay in the adjuvant therapy when faced with this complication.      Studies performed in this groups of patients report a readmission rate of 17-21% for     dehydration.      Loperamide has been shown to significantly decrease the daily volume of weight of stool in     these patients.      The purpose of this study is to establish whether loperamide given at 4mg three times daily     for 14 days from day of discharge empirically decreases 30 days readmission rate for     dehydration.      The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the     readmission rates, that severity of dehydration will be decreased.   "
78095|NCT02263664|"     Microcirculatory alterations occur in critically ill patients and those undergoing major     surgeries. The severity of perioperative microvascular alterations appear to be related to     the severity of organ dysfunction after surgery. Non-cardiac thoracic surgeries comprise a     subgroup of high risk surgical procedures which have the potential to significantly affect     and impair microcirculatory function but this patient population has not been well studied.     Esophagectomy surgery in particular produces a profound systemic inflammatory response which     correlates with a number of adverse outcomes. It is likely, though unproven, that     microcirculatory derangements may underly these phenomena. Though the study of     microcirculatory dysfunction in thoracic surgery is in its infancy, the body of available     evidence at this point supports the following hypotheses; that microcirculatory derangements     and dysfunction 1) occur during major surgeries including transthoracic esophagectomy 2) may     be related to SIRS, 3) may predict adverse outcomes, and 4) may be amenable to modification     via specific therapies.      We propose a prospective observational study to determine the effects of transthoracic     esophagectomy on microcirculatory function. Two hundred patients meeting inclusion criteria     undergoing planned transthoracic esophagectomy via thoracotomy incision will be prospectively     enrolled at The University of Virginia. Patients will be followed for 28 days or until     discharge from the ICU. Evaluation of the sublingual, gastric serosal and mucosal tissues     will be performed using sidestream dark field (SDF) imaging using the CytoCam® by Braedius     Medical BV (Huizen, The Netherlands). Scoring of the microcirculation will include an index     of vascular density (perfused vessel density), an assessment of capillary perfusion     (proportion of perfused vessels and microcirculatory flow index) and a heterogeneity index.      Note: the CytoCam® will only take a series of images as consistent with a microscope of     exposed tissue. Also, the FDA Office of Device Evaluations (ODE) General Surgery Devices     Branch One - Light Based/laser (GSDB1) has deemed this device to be exempt from 510(K)     approval.      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5021      Data from patient's medical charts before and after surgery (30 days post) will be used for     elucidation of specific complications. We will use the cardiovascular and respiratory     components of the SOFA score as independent measures of organ dysfunction. Acute kidney     injury will be defined by the AKIN criteria as an increase of at least 50% above baseline     serum creatinine and will be graded from stage 1 to 3.   "
78096|NCT02263651|"     The objective of this study is to compare quilting suture of the dead space without     drainage of the pectoral area to conventional closure with drainage to prevent post-operative     seroma requiring intervention (aspiration or surgical intervention) within 21 days after     mastectomy for breast cancer.   "
78097|NCT02263638|"     Treatment of refractory hemochromatosis rheumatism by Anakinra. Prospective, multicenter,     non-randomised, single-arm, open-label, phase II trial.   "
78098|NCT02263625|"     The aim of the present study is to investigate whether there are differences in indication     for ventral hernia repair and surgical approach among hernia surgeons from different     geographical regions of Denmark.   "
78099|NCT02263612|"     The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of     present study is to use large-scale data from DHD to uncover risk factors for long-term (30     days postoperative and later) readmission, reoperation, death and reoperation for recurrence     after incisional hernia repair with use of a synthetic mesh.   "
78100|NCT02263599|"     The aim of this study is to evaluate on which indication patients are offered operative     treatment for their ventral hernia, and to investigate the natural course of ventral hernia     in the population of patients not offered operation.   "
78101|NCT02263586|"     Aim of the study is examining the incidence of the occurrence of hyponatremia during a     Triathlon   "
78102|NCT02263573|"     The primary purpose of the protocol is to determine the effects of a new program of PEP'C     PEP'C with constant load and intermittent recovery (PEP'C-R) on endurance parameters of     older seniors.      The study hypothesis: the investigators propose that PEP'C-R training offers a significant     improvement in endurance parameters for older seniors.      The secondary objectives are to determine the effects of PEP'C-R on maximal     cardio-respiratory function, FMD (Flow-mediated dilation), PWV (pulse wave velocity),     systolic and diastolic heart function, body composition (measured by impedance), biological,     functional and cognitive functioning and quality of life.   "
78103|NCT02263560|"     Many neurological patients express enhanced deficits while walking in a dark room (or during     the night): the supraspinal structures involved in this navigational deficit have not been     identified yet. In this project, the investigators will study post-stroke gaits of human     patients and compare them to those of a control population during a goal-oriented task     performed in different visual conditions.      The investigators want to test the hypothesis that during simple goal-oriented locomotor     tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express     navigational deficits.   "
81900|NCT02213965|"     A peripheral intravenous catheter is the most commonly used vascular access device in     medicine. Primary objective is to compare insertion and handling of two peripheral     intravenous catheters in clinical routine.   "
78104|NCT02263547|"     Primary Objective To determine if colestipol hydrochloride tablets can accelerate the     elimination of teriflunomide. Teriflunomide will be administered for 14 days followed by     colestipol dosing of 11 days. Total duration of the study is 40 days.      Secondary Objectives To collect information on the pattern of side effects with use of     colestipol hydrochloride after teriflunomide administration and to determine the best     duration of therapy needed for adequate elimination   "
78105|NCT02263534|"     Based on previous studies the single incision minisling is an easy less invasive procedure     with fewer complications and cure rate similar to conventional midurethral slings in the     treatment of female stress urinary incontinence. The aim of this study is to test the     hypothesis that the single incision mini-sling placed in the U position is not inferior to     TVT in this patient population.   "
78106|NCT02263521|"     Development and validation of a measure of physician work motivation.   "
78107|NCT02263508|"     Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumors     have disappeared, disease progression per modified Immune-Related Response Criteria (irRC),     or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects     will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression     per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment.     In Phase 3, Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1)     or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of     pembrolizumab or end of treatment due to disappearance of injectable lesions, complete     response, disease progression per irRC-RECIST or intolerance of study treatment.   "
78119|NCT02263352|"     This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two     months) as an adjunct to scaling and root planing in chronic periodontitis patients with type     2 diabetes mellitus.   "
78182|NCT02262533|"     The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics     (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.   "
78108|NCT02263495|"     Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective     chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the     preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a     maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as shown     in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin Oncol     31(14):1732, 2013).      Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival     benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of     anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011).     Eribulin was also reported its promising efficacy in another randomized phase III study that     demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS     2012). Both study results showed potential clinical benefit in patients with triple negative     MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for early     line therapy in patients with metastatic breast cancer.      Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of     neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity     profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in     a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared     to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG.      In phase I trial, eribulin in combination with gemcitabine was feasible in patients with     advanced solid tumor treated with chemotherapy (< 3 lines) (Goel R, et al, 2009 ASCO).      Based on this rationale, the investigators are to conduct randomized phase II study comparing     EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as first-line     chemotherapy.      A total of 112 patients will be recruited. Patients will be randomized to a treatment arm by     permutated method. The randomization ratio is 1:1. This study is multi-center, randomized,     open label study.   "
78109|NCT02263482|"     Heart failure is a clinical syndrome that is the common end of several cardiac diseases with     symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve     respiratory and general functional capacity of these patients, there are strategies that can     be used such as inspiratory muscle training and peripheral muscle training (dynamic     resistance training).   "
78110|NCT02263469|"     The objective of this study was to assess the safety and efficacy of Replenine®-VF in     children enrolled in the study, under the age of six years, with severe haemophilia B.   "
78111|NCT02263456|"     The purpose of this study is:        -  to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity          Factor IX concentrate, when given as a bolus dose of 75IU/kg.        -  to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3          months apart) and recovery if patients changes batches.        -  to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with          severe haemophilia B.   "
78112|NCT02263443|"     Our study perform In Department of Gynecology, Faculty of Medicine, Chiang Mai University. In     our study we divide patients into 3 groups ,First group patients doing Soap suds enema     (S.S.E.), second group patients doing sodium chloride enema and the last group patient Non     per os (NPO) before surgery. Our hypothesis is no different about surgical view in 3 groups     and lower side effects in patients in no bowel preparation group.      Research objectives        1. Comparing the surgeon satisfaction ,surgical view and bowel handling in operation of          soap suds enema group, sodium chloride enema group and the NPO group in patients under          going exploratory laparotomy in gynecologic surgery.        2. Comparing the side effects of soap suds enema group, sodium chloride enema group and the          NPO group.      Inclusion Criteria      1. Women under going laparotomy in gynecologic surgery 2. Surgeon consider not too difficult     surgery. 3. Can understanding Thai language. 4. Can communicate with researcher. 5.     Consenting participants. Exclusion Criteria        1. Pregnancy or suspected pregnancy.        2. Laparoscopic surgery        3. Do not consent to participate in research        4. Gastrointestinal infection        5. Underlying disease such as Intestinal disease, patient who cannot under going bowel          preparation ,heart disease ,seizure.        6. Surgeon consider difficult surgery such as fixed mass or uterus with others organs from          per vaginal examination or very huge mass or history of difficult surgery or history of          severe adhesion in abdominal cavity.   "
78113|NCT02263430|"     Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment     of different forms of chorea, including Huntington's disease (HD).   "
78114|NCT02263417|"     The purpose of this study was to compare the subthalamic nucleus(STN) with the globus     pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically     refractory dystonia.   "
78115|NCT02263404|"     Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of     effective treatments. AN becomes intractable in around 20%, resulting in huge individual and     healthcare costs. The study will help patients with severe AN using DBS. Individuals with     severe intractable AN will be eligible to take part in the study.   "
78139|NCT02263092|"     This study aims to understand metaplasticity through the association of transcranial direct     current stimulation (tDCS) and physical exercise. For this purpose, the study will be     separate in 2 phases: in the first phase the aim is verify the effects of physical exercise     on cortical excitability. After this 1st phase two intensities of physical exercise will be     chosen for the second phase. In the 2nd phase, subjects will undergo to anodal, cathodal and     sham tDCS plus physical exercise.   "
78116|NCT02263391|"     This study gathers information about HIV testing utilization and influences on HIV testing     decisions among young, general population Russian women at-risk of HIV exposure. The study     compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in     vs. opt-out) and conducts one of the first randomized experimental comparisons of these     strategies. The overarching goal is to gain knowledge that can be used to increase     utilization of HIV testing among at-risk young women and offer gender-specific strategies for     improving prevention.   "
78117|NCT02263378|"     The purpose of this study is to evaluate whether a supplement in which ellagic acid plus     annona muricata are combined, may modulate the immune response to high risk HPV infection.     Sixty women will be enrolled in a randomized, controlled study, having a histological     diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the     activation of onco suppressor protein by the supplement and secondary outcome is the     clearance of HPV infection in the treated group.   "
78130|NCT02263209|"     Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard     coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless     total hip arthroplasty   "
78131|NCT02263196|"     The purpose of this study was to compare the efficacy of combination of alcohol and povidone     iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to     vascular access area in hemodialysis patients.   "
78183|NCT02262520|"     The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK)     of multiple-dose Digoxin in healthy subjects.   "
78120|NCT02263339|"     The purpose of this study is to learn more about multiple sclerosis (MS). The investigators     are studying whether aerobic exercise is better than a stretching program at improving brain     health in people with MS. We want to learn:        1. If it is safe and practical for people with MS to participate in an aerobic exercise          program with the goal of increasing cardiac fitness. Cardiac fitness is measured with          exercise stress tests at the beginning and end of the study.        2. If aerobic exercise improves brain metabolism, a reflection of brain health, more than          stretching. Brain metabolism is measured by MRIs at the beginning and end of the study.      There is a 50% chance of being in the aerobic exercise or the stretching program.      There are between 8 and 36 visits to OHSU, depending on the intervention group. The total     duration of the study is at most 21 weeks.   "
78121|NCT02263326|"     HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and     plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of     Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen     will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their     current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as     confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24   "
78122|NCT02263313|"     In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in     particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).   "
78123|NCT02263300|"     Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on     the development of fiberoptic intubation skills?      Is it necessary to teach both orientations or is the supine view transferable to the upright     position?      Which method demonstrates longer skill retention?      The hypotheses: Both orientations must be practiced and the upright skill is harder to learn     but is retained for longer.   "
78124|NCT02263287|"     Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy     series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology     registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many     symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at     the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value     of both diagnostic criteria. To date there is still a need for a tool able to discriminate     patients with pure DLB from those expressing common signs with both AD and DLB and those with     pure AD. The purpose of this study is to validate a semi quantitative scale designed to     reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The     investigators hypothesized that the score obtained may differentiate between AD, DLB and     patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated     with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with     potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a     preliminary work preceding further studies correlating the LeSCoD score with functional     imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an     improvement in demented patients' care, as well as a better patient selection for further     therapeutic studies   "
78125|NCT02263274|"     The primary study objective is to measure the electrical fields evoked by tDCS using subjects     who have implanted intracranial electrodes as part of their evaluation for epilepsy surgery.     The measurements obtained in these subjects and their brain MRI will be employed to validate     existing mathematical models.      In the future, these refined models can be used to target tDCS to predetermined brain regions     in healthy and subjects and patient populations. As described above in the safety section,     the intensities of stimulation applied in this project are not expected to produce changes in     brain function, are below intensities commonly applied in clinical trials, and fall well     below safety limits suggested by animal studies.   "
78126|NCT02263261|"     Use of a HADM and implant in post-mastectomy breast reconstruction.   "
78140|NCT02263079|"     This randomized, controlled, parallel group, open-label multicenter study will evaluate the     efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus     lamivudine or entecavir compared with an untreated control group in participants with HBeAg     positive CHB in the immune tolerant phase.   "
78127|NCT02263248|"     The Investigators are conducting a research study to learn about the safety and benefit of     using a medication called buprenorphine for patient with difficult to treat depression . This     research study is testing whether combining two medications will be effective in treating     depression when initial treatment with just one antidepressant does not relieve the     depressive symptoms ; this is what is called  difficult to treat depression  or  treatment     resistant depression . The two medication the investigators are using are  an     anti-depressant medication called venlafaxine XR ( the generic form of Effexor ) and     buprenorphine . Buprenorphine is a medication that is FDA approved for the treatment of     opioid dependence. The investigators are testing whether adding buprenorphine to venlafaxine     enhances treatment response.   "
78128|NCT02263235|"     In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which     represents, as in other developed countries, a major public health issue. In many cases, AD     diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the     diagnosis is however particularly important in the perspective of the validation and use of     new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis biomarkers     fell short in the detection, of atypical/mixed cases, of some differential diagnosis, and in     differentiating rapid or slow clinical evolutions. Hence, CSF analysis gives a unique     opportunity to detect and validate biomarkers in many neurological disorders. Nevertheless,     in medical practice, CSF biological analysis is currently limited to a small number of     analytes.Quantitative and targeted mass spectrometry, especially operated in the Multiple     reaction monitoring mode (MRM), represents an alternative to immunodetection and could be     used to detect specific biomarkers in complex matrices such as plasma by specifically     discriminating the proteotypic peptides corresponding to each proteins. Mass spectrometry has     also the ability to distinguish and quantify isotopically labelled and unlabeled selected     targets. This ability was used in a publication by the group of R. Bateman (Washington     University, St Louis, USA) who could, after administering stable isotope-labelled leucine,     evaluate Ab synthesis and clearance in humans. This approach has an enormous potential to     study the metabolism of proteins within the human CNS and consequently help in the     understanding and diagnosis of neurological disorders.The main objective of this program is     set up a targeted quantitative mass spectrometry method for existing and stable     isotope-labelled CSF biomarkers in the neurological field; exploit this approach for     diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.   "
78129|NCT02263222|"     This is an open-label dose-escalating study to evaluate the tolerability and systemic     exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary     unilateral TKA.   "
78132|NCT02263183|"     Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing     to this special process, RPO possesses a special flavour and aroma, and is rich in     phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene,     phenolic acids, flavonoids and co-enzyme Q10. These phytonutrients are the main constituents     through which palm oil exhibits its nutritional properties. Among the major health promoting     properties are anti-cancer, cardio-protection, anti-angiogenesis, cholesterol inhibition,     brain development and neuro-protective properties, antioxidative defence mechanisms,     provitamin A activity and anti-diabetes. As red palm oil has variety of phytonutrients and     health benefits, the potential of improved cardiovascular health should be considered to     understand better and thus treasure more our golden oil.   "
78133|NCT02263170|"     With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary     consortium consisting of representatives ranging from clinical medicine via microelectronics     towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The     aim of this campaign includes development of implantable prototype devices acting as     artificial continence muscles using low-voltage electrically activated polymers (EAPs)     controlled by implemented pressure sensors and the patient.      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal     sphincter complex are of cardinal importance. Most of the existing data on anatomy and     physiology results is based on old studies and almost no data on biomechanical properties are     available. However, new technologies or even merging data from different examination methods     might provide new information in this field.   "
78134|NCT02263157|"     The study is designed to evaluate the association between nosocomial bloodstream infection     and the occurrence of thrombocytopenia in surgical critical ill patients.   "
78135|NCT02263144|"     The purpose of this prospective, non-interventional study is to validate the Narrow Band     Imaging International Colorectal Endoscopic (NICE) classification for differentiating     subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color     Enhancement (FICE) technology with high-definition without optical magnification.   "
78136|NCT02263131|"     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated     Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single     intramuscular injection.   "
78137|NCT02263118|"     The purpose of this study was to determine whether exposure to m-health platforms promoting     recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding     message to participant mothers, and in improving weight evolution of infants.   "
78138|NCT02263105|"     Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard     treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive     Cancer Network (NCCN) as a chemotherapeutic agent in salvage treatment for recurrent     high-grade gliomas, was shown to reduce O6-alkylguanine DNA-alkyl transferase (AGAT) activity     and potentially capable of enhancing the antitumor effects of temozolomide (TMZ). Compared to     the standard 5-day TMZ regimen, alternating weekly regimen that deliver more prolonged     exposure of TMZ may lead to higher cumulative doses, and may deplete more O6-methylguanine     DNA methyltransferase (MGMT), thus reducing the resistance of tumor cells to TMZ.      The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and     tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent     high-grade gliomas.   "
78141|NCT02263066|"     To assess and describe real-life treatment choices for rFⅧ contained regular     prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China     (2007-2013)   "
78142|NCT02263053|"     The Temporomandibular Joint (TMJ) is one of the most complex joints in the individual. It is     composed of the mandibular condyle is positioned within the glenoid fossa of the temporal     bone, and the articular disk that separates these two bones. The normal biomechanics of the     TMJ is the concave / convex relationship between the condyles and the articular disc. The     movements of the TMJ joint are: mandibular depression and elevation (opening and closing of     the mouth), mandibular protrusion and retraction, and lateral deviations. The DTM is a     musculoskeletal disorder of the masticatory system that affects over 25% of the population.     Physical therapy can be adopted this treatment in order to relieve musculoskeletal pain,     reduce inflammation and restore normal motor functions. The physical therapy interventions     taken include electrotherapy, exercise therapy, acupuncture and manual therapy. Overall     objective is to assess the immediate effects of previous mobilization versus flow amplitude     of mandibular depression in patients with temporomandibular dysfunction. The type of study     will be a randomized study of two parallel groups balanced distribution (1: 1) and     double-blind. The research will be conducted in the Laboratory of Human Movement Analysis of     Physiotherapy, Faculty of Medicine, Federal University of Ceará. The study population will     consist of residents in the city of Fortaleza-CE individuals who voluntarily seek to     participate in the study due to symptoms of TMD. Data, anthropometry, application of Research     Diagnostic Criteria for Temporomandibular Disorders will be collected. The physiotherapist     responsible for the assessment before and after the interventions will be blind with respect     to the distribution of the treatment groups. The patient will also be blind, because you will     not know whether or caudal anterior mobilization was performed. Randomization codes are     generated by computer using Random Allocation Software (version 1.0.0) at a ratio of 1: 1 by     a researcher not involved in the data collection. These codes will be placed in sealed,     opaque envelopes being numbered consecutively, which will ensure the covert allocation of     study participants. Our data are considered confidential as joint property of the parties     involved.   "
78143|NCT02263040|"     The objective of this pilot study is to assess the immunogenicity and reactogenicity of     Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare     workers.   "
78144|NCT02263027|"     This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine     the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated     with systemic reactions in these workers.   "
78145|NCT02263014|"     The goal of this research study is to learn more about how different treatment decisions may     influence the quality of life in women with breast cancer. Researchers want to use what is     learned from this study to help future patients with breast cancer to be more informed when     making treatment decisions.   "
78211|NCT02262156|"     The aim of the study is to compare the effect of group-cognitive-behavioral therapy     (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in     patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.   "
78212|NCT02262143|"     Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus     rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center,     double-blind, phase 3 study   "
78217|NCT02262078|"     Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that     has no proven effective treatment. This study will assess the effects of nebulized inhaled     nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred     to the catheterization lab.   "
78146|NCT02263001|"     Musculoskeletal injuries resulting in pain are one of the most common reasons for disability     and missed duty among military personnel. Additionally, these injuries may create impairment     in the area of optimal function, sleep and mood that may not be completely resolved with     currently available therapies. This scenario creates the setting for testing and     incorporation of additional treatment options to potentially improve care outcomes. Recent     investigations have examined the adjunctive use of auricular therapy, which utilizes various     interventions, typically needle-based, to stimulate the ear. This intervention appears to     modulate the autonomic nervous system to produce more rapid onset of pain relief and     reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy,     active duty personnel presenting with an acute or sub-acute musculoskeletal injury triaged to     outpatient care for treatment will be studied. Subjects randomized to auricular treatment     will receive, in addition to standard care, up to 12 treatments over a maximum of 3 months     from a clinician trained in auricular therapy. This trial will specifically examine whether     the addition of a specific auricular therapy protocol to standard care will have a beneficial     impact on the pain and functionality of military personnel who sustain an acute or sub-acute     musculoskeletal injury.   "
78147|NCT02262988|"     The purpose of this study is to assess the potential benefit of enhancing total knee     arthroplasty (TKA) surgery using some of your own cells taken from fat tissue that may be     able to help recovery and repair of knee tissues.   "
78148|NCT02262975|"     This study is an observational study conducted prospectively under routine clinical setting     for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by     donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected     institutions of about 8 countries in Asia.   "
78149|NCT02262962|"     The purpose of this research is to design and test a new model for delivery of well-child     care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators     used an innovative expert panel and community advisory board process to develop this new     model for the delivery of WCC to low-income families in partnership with our partner     community pediatric practices. The new model of care utilizes a trained health educator, or     Parent Coach at every well-visit from 0-3 years of age. The Parent Coach provides a range     of services, including health education and guidance, developmental screening, and     psychosocial screening and services. The Parent Coach works with the Primary Care Physician     to ensure that the family's needs are met for that well-visit. As a part of this new model     for well-child care, the parent also uses a web-based tool to help prioritize needs for the     visit and complete any necessary pre-visit screening. Parents receive additional education     and guidance from a text message service and have access to the Parent Coach outside of the     visit.      The randomized controlled trial (RCT) of this new model of care will include 250 families who     will be enrolled at participating clinics if the child is under 1 year of age. Parents will     receive the intervention for 12 months and will complete surveys to collect data on their     experiences of care. Our hypothesis is that this new model of care will be more     patient-centered and more effective in providing recommended preventive care services than     usual care, and that it will be a sustainable and feasible model for the partner practices.   "
78150|NCT02262949|"     The purpose of this study is to assess the deliverability, clinical utility, safety and     effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.   "
78167|NCT02262728|"     The purpose of this study is to assess the efficacy of a 12-week regimen containing     simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the     liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver)     C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of     study drug treatment (SVR12).   "
78168|NCT02262715|"     The purpose of this study is to investigate the drug-drug interaction between VX-787 and     oseltamivir, when co-administered at steady-state in healthy participants. In addition the     safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the     blood and tissues over time) of VX-787 will be assessed.   "
78169|NCT02262702|"     The aim of this observational study is to compare the use of an extended release paracetamol     formulation with standard paracetamol in a cohort of Australian concessional patients with     osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.   "
78151|NCT02262936|"     Nocturia, or voiding at night, is an extremely troublesome symptom which is highly prevalent     in the elderly. Desmopressin is a treatment for nocturia but it can result in hyponatremia     (low blood sodium), particularly in those aged 65 and older. Fesoterodine is used for the     treatment of overactive bladder (OAB). Recent trials showed Fesoterodine was effective in     reducing nocturia. This study aims to answer the following: In women 65 and older with severe     nocturia, is Fesoterodine more effective than Desmopressin in reducing the number of night     time voids? Does Fesoterodine have a better side effect profile compared to Desmopressin?      The study design is a 12 week randomized double-blinded trial of Fesoterodine and     Desmopressin in the treatment of severe nocturia in women aged 65 and older. This will be     conducted at the Urogynecology Unit at Mount Sinai Hospital (MSH) and Baycrest. A 3 day     voiding diary and Nocturia, Nocturnal Enuresis and Sleep-interruption Questionnaire (NNES-Q)     will be completed at baseline and at week 12. The primary outcome will be the number of night     time voids in the Fesoterodine group compared to the Desmopressin group, 12 weeks after     starting treatment. Secondary outcomes include changes in the NNES-Q scores and the safety of     each medication.      This study is expected to show that, in women 65 and older with severe nocturia, Fesoterodine     will be more effective in reducing the number of night time voids, reducing the volume of     voided urine, increasing the duration of sleep prior to first nocturnal void and improving     quality of life relative to Desmopressin. Fesoterodine will also be better tolerated, with     fewer significant adverse events, relative to Desmopressin.   "
78213|NCT02262130|"     Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and     with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual     treatment, leading to a large impact on quality of life. New treatment options are warranted.     The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody     recently approved in chronic spontaneous urticaria, in this setting.   "
78214|NCT02262117|"     A prospective, randomized, controlled, open two-arm study to evaluate the interest of the     pre-conceptional endometrial immune profiling to increase birth rates.   "
78152|NCT02262923|"     Metoclopramide is a dopamine D2 receptor antagonist with antiemetic and gastrokinetic     properties which has been approved for use in pregnant women. Women with polycystic ovary     syndrome (PCOS) have been found to have lower dopaminergic tone and increased ovarian     vascularity and vascular endothelial growth factor (VEGF) levels compared to controls. During     ovarian stimulation, PCOS patients exhibit greater sensitivity to gonadotropins and increased     follicular development. Administration of dopamine D2 antagonists may mimic the low     dopaminergic tone noted in PCOS patients, increase VEGF levels, angiogenesis, and     subsequently improve follicular growth during ovarian stimulation. This strategy could be     used to improve IVF outcomes in poor responders.      The investigators hypothesize that, compared to gonadotropin use alone, the use of     metoclopramide in combination with gonadotropins in poor responders undergoing IVF will     result in an increased number of mature oocytes obtained at oocyte retrieval and improved IVF     outcomes.   "
78153|NCT02262910|"     The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to     identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously to     patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics     (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of     MOR209/ES414.      The primary objective of Stage 2 of the study is to evaluate the clinical activity of     MOR209/ES414 in patients that have or have not received prior chemotherapy. Secondary     objectives are to further characterize the safety profile, PK, PD, and immunogenicity of     MOR209/ES414.   "
78154|NCT02262897|"     Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis,     even though the first line chemotherapy showing about 70% response rate. Most of the patients     will relapse with in 6 months after the chemotherapy and the following therapy such as second     line chemotherapy have a very limited efficacy to these patients. Currently, there is no     standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).      As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases     report in the patients with SCLC, the aim of this clinical trial is to investigate the     efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive     disease and failed to first line/ second line chemotherapy.   "
78155|NCT02262884|"     A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE     RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL     INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL     NEPHRECTOMY   "
78156|NCT02262871|"     Many patients with cystic fibrosis (CF) require hospitalization and/or Intensive Care Unit     (ICU) admission because of acute exacerbation of chronic respiratory failure or for any acute     deterioration of clinical status. Non-invasive ventilation (NIV) is the first option for the     clinical management of CF patients with moderate-to-severe respiratory distress and NIV has     been shown to improve gas exchange, reduce respiratory muscle work and improve pulmonary     function in patients with obstructive lung disease in general and those with acute CF     exacerbation. High-flow nasal oxygen cannula (HFN) is a relatively new system providing     heated and humidified, high-flow (50L/min) oxygen through the nostrils. This device provides     a small positive pressure, probably washes-out the pharyngeal dead space, reduces inspiratory     resistance, and possibly facilitates secretion clearance. The technique is very well     tolerated. From a physiologic standpoint, this device could help CF patients by improving gas     exchange, reducing respiratory workload, and facilitating mucus clearance. Non-interrupted     delivery may be possible given better clinical tolerance in contrast with bi-level positive     pressure NIV. Whether the short-term physiological efficacy of HFN is comparable to NIV is     unknown and there is no study on the benefit of HFN in CF patients.      The aim of this study is to compare the physiological effects of HFN and NIV in CF patients     requiring ventilatory support. Our hypothesis is that HFN will not be inferior to NIV, as     evaluated by breathing pattern, gas exchange, and respiratory workload and will decrease dead     space. In addition, comfort and preference between the two techniques will be evaluated.   "
78157|NCT02262858|"     Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide     (HCTZ) fixed dose combination compared with its monocomponents   "
78158|NCT02262845|"     The purpose of this study is to document clinical utility and distribution of indications for     short term pancreatic stenting, and stent type preference by indication at tertiary referral     centers with expertise in pancreatic endotherapy.   "
78205|NCT02262234|"     Chronic pain (pain that is that is present for a long period of time) is very common among     people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat.     Many treatments reduce chronic pain only partially. As a result, many people with SCI must     find ways of accomplishing daily activities even though they have pain.      The purpose of this research study is to determine how well two different kinds of education     programs reduce the extent to which chronic pain interferes with daily life and well-being.   "
78170|NCT02262689|"     The study evaluates the effect of GSK2256294 exposure at steady state on pulmonary artery     systolic pressure (PASP) in healthy volunteers, under hypoxic conditions, after 7 days of     dosing. It is single centre, double blind, randomized, placebo-controlled study to be     conducted in approximately 30 healthy volunteers. Subjects will be screened no more than 30     days. Subject will be admitted in clinical unit on Day -1. Subject will be dosed for 7 days     in unit in morning on all days except for dosing on Days 3 -6. Dosing on Days 3 -6 will occur     at home. Subjects will return to the unit on the evening of Day 6 and remain there until Day     8. Subjects will undergo echocardiography under normoxic and hypoxic on Day 1 pre-dose and on     Day 7 post-dose. Subject will be followed up for 28- 32 days after discharge. The maximum     estimated time that a subject will be enrolled in the study is 62 days from the screening     visit to follow up.   "
78171|NCT02262676|"     Depict demographic and clinical features of patients with atrial fibrillation treated with     rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice   "
78172|NCT02262663|"     This is a study in healthy women of reproductive age to investigate the pharmacodynamics     (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral     administration of 4 different doses over 84 days, using a randomized, parallel-group,     multicenter design.   "
78215|NCT02262104|"     The purpose of this study is to investigate the effect of an exercise program on nursing home     patients with dementia.   "
78159|NCT02262832|"     Background:      - Generalized lipodystrophy can cause high blood fat levels and resistance to insulin. This     can lead to health problems including diabetes. Researchers have found that the drug     metreleptin improves health in people with this disease.      Objective:      - To test the safety and effectiveness of metreleptin.      Eligibility:        -  People ages 6 months and older with generalized lipodystrophy who:        -  have received metreleptin through NIH studies AND        -  cannot get it through approved or compassionate use mechanisms in their home country.      Design:        -  Participants will come to NIH approximately every 6 months during year one, then every 1          2 years. Financial assistance may be available for travel within the U.S.        -  At visits, participants will get a supply of metreleptin to take home for daily          injections. They will have:        -  plastic catheter placed in an arm vein.        -  blood tests, urine collection, and physical exam.        -  oral glucose tolerance test, drinking a sweet liquid.        -  ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the          skin and pictures are taken of the organs.        -  echocardiogram, which takes pictures of the heart with sound waves.        -  Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they          breathe is measured.        -  Participants will have up to 3 DEXA scan x-rays per year.        -  Participants may have:        -  annual bone x-rays.        -  liver biopsies every few years. A needle will be inserted into the liver to obtain a          small piece. Participants will sign a separate consent for this.        -  Participants must be seen regularly by their local doctors and have blood tests at least          every 3 6 months at home.   "
78160|NCT02262819|"     Background:      - Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory     system. Sometimes people who get sick with staph infection do not get better with standard     treatment. These staph infections can be serious and even deadly. Researchers want to find     out why some people are more likely to get the infection.      Objectives:      - To look at the immune response of the skin when it is exposed to bacteria.      Eligibility:        -  People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph          infections.        -  Healthy volunteers.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may          have additional tests if needed. If they had a recent biopsy, researchers may ask for a          sample from it.        -  Some participants will spend the night at the clinic. Their vital signs will be taken          and they will have blood drawn. Some participants will take aspirin or ibuprofen          starting 2 days before their stay.        -  Some participants will have blisters created on the inside of their forearm. Suction          will pull a layer of skin from their arm. Skin will be removed. Different solutions will          be applied to the blisters. Up to 3 biopsies may be taken.        -  Children will not have blood tests or biopsies.        -  Participants will be called every day for 10 days, then at 30 days after the procedure.        -  Participants will have a follow-up visit 10 days after the procedure.        -  Participants who did not get blisters or biopsies will not have any follow-up          appointments.   "
78161|NCT02262806|"     Background:      - Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can     lead to health problems including diabetes. Researchers have found that the drug metreleptin     improves health in people with this disease.      Objective:      - To test the safety and effectiveness of metreleptin.      Eligibility:        -  People age 6 months and older with partial lipodystrophy who        -  have received metreleptin through NIH studies and shown improvement AND        -  cannot get metreleptin other ways.      Design:        -  Participants will come to NIH approximately every 6 months during year one, then every 1          2 years. Financial assistance may be available for travel within the U.S.        -  At visits, participants will get a supply of metreleptin to take home for daily          injections, or it can be shipped to them inside the U.S. They will have:        -  plastic catheter placed in an arm vein.        -  blood tests, urine collection, and physical exam.        -  oral glucose tolerance test, drinking a sweet liquid.        -  ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the          skin and pictures are taken of the organs.        -  echocardiogram, which takes pictures of the heart with sound waves.        -  Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they          breathe is measured.        -  Participants will have up to 3 DEXA scan x-rays per year.        -  Participants may have:        -  annual bone x-rays.        -  liver biopsies every few years. A needle will be inserted into the liver to obtain a          small piece. Participants will sign a separate consent for this.        -  Participants must be seen regularly by their local doctors and have blood tests at least          every 3-6 months at home.   "
78162|NCT02262793|"     To investigate the relative bioavailability of telmisartan respectively of dipyridamole after     concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid     (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP     in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone     (Reference 2).      To investigate the relative bioavailability of dipyridamole respectively of telmisartan     administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2)     relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to     telmisartan in Micardis® alone (Reference 2).   "
78163|NCT02262780|"     Group 1:      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and     T80/H12.5)      Group 2:      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7     days)   "
78164|NCT02262767|"     This study will test the hypothesis that PF-06649751 with continuous co-administration of     trimethobenzamide hydrochloride (TMB) with will be safe and well tolerated. Single doses of     PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose     projected to be under the current limits for drug concentration.   "
78165|NCT02262754|"     PF-06372865 In Subjects With Chronic Low Back Pain   "
78166|NCT02262741|"     This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the     safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of     MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell     carcinoma of the head and neck.   "
78216|NCT02262091|"     The aim of this research is to assess the immune enhancing property of food fibers in the     elderly population.   "
78184|NCT02262507|"     Significant morbidity, mortality, and related costs are caused by traumatic brain injury     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save     lives, and the huge costs currently being experienced for life-treatment of surviving     victims. An externally-worn medical device that applies mild jugular compression according to     the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC     (Q30). Initial research suggests that the Device has the potential to reduce the likelihood     of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions (OAE) is     that the investigators need a physiologic, non-invasive method to evaluate the brain     responses to mild jugular compression across multiple age groups. To determine this with MR     imaging is currently cost prohibitive. The investigators pilot data from the parent IRB     indicates a consistent response measured via wideband absorbance in young adults. Therefore,     a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ     this technology across a wide range of ages.   "
78185|NCT02262494|"     The main objective of our study is to determine the diagnostic performance of an     ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by     experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients     with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed     by a vascular exploration expert.   "
78186|NCT02262481|"     The purpose of this study is to evaluate the effect of oral progesterone supplementation in     preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy     period, and its side effect.   "
78187|NCT02262468|"     assess results of metal on metal hip replacements carried out at warwick hospital   "
78188|NCT02262455|"     This is a Phase I study to test the safety, pharmacokinetics and effectiveness of STM 434     alone, or in combination with liposomal doxorubicin, in patients with ovarian cancer or other     advanced solid tumors.   "
78189|NCT02262442|"     The aim of this prospective study is to examine the benefits and risks of administration of     local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)     during flexible bronchoscopy.   "
78190|NCT02262429|"     Newly admitted patients will be screened for risk of malnutrition. Patients will receive     either the feeding protocol or current oral nutrition supplement (ONS) practice, pending     location. Patients will continue the nutrition plan taking the supplement post discharge.     Study team will follow-up with telephone calls to help support post-discharge ONS compliance.     Quality and service utilization data will be gathered for analysis.   "
78347|NCT02260388|"     The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of     the University of Kansas Medical Center, is to learn about the safety and effectiveness of     nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory     polyneuropathy (CSPN).   "
78191|NCT02262416|"     In-Vitro Fertilisation (IVF) is the term commonly applied to a form of treatment for     infertility that involves controlled ovarian hyperstimulation, egg maturation, egg     collection, fertilisation, embryo culture and finally embryo transfer. The period after egg     collection is called luteal phase. In Australia, vaginal progesterone is routinely used to     support the lining of the uterus so that it is susceptible to implantation of the embryos.      More recently, there has been some suggestion that additional supplementation of luteal phase     with GnRH agonist increases clinical pregnancy and live birth rate. These studies are however     heterogeneous and results were inconsistent.      This study is a prospective randomised controlled trial of additional GnRH agonist in luteal     phase of antagonist cycle. The primary hypothesis is that GnRH agonist increases the number     of live birth . The secondary hypothesis is that this increases the clinical pregnancy rate,     on-going pregnancy rate, without affecting the miscarriage rate, ovarian hyperstimulation     rate and multiple pregnancy rate.   "
78192|NCT02262403|"     The main objective of this study is to characterize the regulatory immune response induced by     hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution     after infection treatment and during potential naturally reinfection.   "
78193|NCT02262390|"     2.1 Primary Study Hypothesis In sub-Saharan Africa, between 2.5-17% of pregnant women are     infected with syphilis [1]. It is estimated that 53-82% of women with untreated syphilis had     adverse outcomes compared to only 10-21% of uninfected women[2]. The investigators and others     have shown that syphilis screening integrated into an HIV antenatal clinic with prevention of     mother to child transmission (PMTCT) is highly accepted with excellent uptake. Unfortunately,     the minority of male partners come in for testing and treatment (1%-27%) which has important     implications for the roll-out of rapid syphilis testing and the inability to detect     reinfection with treponemal antibody test as the test will remain positive despite treatment.     The investigators hypothesize that sending an SMS reminder or a telephone call reminder by a     health care worker will be more effective than a standard notification slip given to women to     bring male partners to antennal clinic for testing and treatment.   "
78194|NCT02262377|"     The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV)     are effective for treating patients with chronic pain and depression.   "
78195|NCT02262364|"     The primary objective of this study is to assess the safety of a single injection of APS.   "
78196|NCT02262351|"     Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment     of AF is one of the best way to prevent stroke. The problem is that because AF may cause     minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is     known that as many as half of all patients with known AF may not be receiving appropriate     anticoagulation for their condition. New technologies are making it possible to improve AF     detection. Subjects in this study will be screened for AF using three simple methods: a     30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood     pressure monitor with built-in AF screening capabilities. If more patients with AF can be     detected, more patients will be able to receive guideline-recommended anticoagulant therapy,     and more strokes, deaths, disability, and dementia will be prevented.   "
78197|NCT02262338|"     AGT-182 is a fusion protein containing idursulfase that is intended to deliver the enzyme     peripherally and to the brain, when administered intravenously. This study is a safety and     dose ranging study to obtain safety and exposure data, as well as information on the     biological activity of the investigational drug.   "
78198|NCT02262325|"     This phase II trial studies how well giving a hypofractionated boost to the primary tumor     before standard chemotherapy and radiation therapy works in treating patients with stage II     or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation     oncology have allowed better radiation targeting which may be able to send x-rays directly to     the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as     cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.     Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and     targeted radiation before standard chemotherapy and radiation therapy may kill more tumor     cells and prevent the cancer from coming back in the location in which it started.   "
78199|NCT02262312|"     Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer     from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron     overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin     is usually used to monitor the iron overload. In this study MDS patients will have a     transient elastography performed which measures the liver's stiffness. The purpose is to     investigate whether liver stiffness measurements are coherent to ferritin levels.   "
78200|NCT02262299|"     A European multi-centre, randomised, double-blind placebo-controlled trial of Pirfenidone in     bronchiolitis-obliterans-syndrome grade 1-2 in lung transplant recipients.      Randomized double blinded, placebo controlled study. Eligible patients are to be randomized     in a 1:1 ratio to receive either Pirfenidone 2403 mg/d or the matching placebo treatment for     6 months.      Primary objective To evaluate the effect of Pirfenidone on the change in FEV1 in liters over     6 months in lung transplant recipients with bronchiolitis obliterans syndrome.   "
78201|NCT02262286|"     Procure blood specimens from individuals presenting to the emergency department with     suspected brain injury.   "
78202|NCT02262273|"     This study will be carried out as a retrospective, non-interventional observational review of     medical records for patients in multiple countries with platinum-sensitive recurrent serous     ovarian cancer. The objectives are to describe in a real-world population, treatment     patterns, BRCA mutation testing and results, overall survival, health care utilization and     also to estimate rates of selected treatment- and/or disease-related side effects   "
78203|NCT02262260|"     To explore a more clinical feasible treatment regime with ranibizumab for DME to provide     satisfactory treatment effect with a lower number of visits and injections.   "
78204|NCT02262247|"     The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic     System to visualize and access specific anatomical locations along with evaluation of the     safety of the device.   "
78206|NCT02262221|"     Randomized, multicenter trial to evaluate the cost-effectiveness of 2 different follows up     programs in head and neck cancer survivors. Patients in complete remission at month 6 (+/- 1     month) after curative treatment will be randomized in two arms according to 2 different     follow up approaches: Non Intensive Follow up approach (Arm A) with no radiologic     evaltuations scheduled, but required only at the occurence of any signs or symptoms and     Intensive Follow up approach (Arm B) with scheduled radiologic evaluations.   "
78207|NCT02262208|"     The aim this study is characterize glycemic variability using linear and nonlinear     mathematical tools, under basal conditions and in response to specific protocols acute     exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes     patients. For this purpose, the sample size will consist of 37 individuals healthy and 32     without type 2 diabetes mellitus wore a CGMS during 3 days. Participants randomly performed     aerobic and eccentric sessions, both in the morning (24h after CGMS placement), and at least     7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose     variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation     (conventional methods) as well as by spectral and symbolic analysis (non-conventional     methods). Physiological mechanisms altered by exercise protocols (Human Soluble Interleukin-6     and Glutathione), will be measured in blood samples.   "
78208|NCT02262195|"     The purpose of the study is to determine if a new pulse oximeter accurately detects     carboxyhemoglobin and methemoglobin when intentionally increased in the blood.   "
78209|NCT02262182|"     Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac     surgery. Classically, the treatment of these patients is based on manual chest physiotherapy.     Our objective is to evaluate the interest of association of positive end expiratory delivery     sessions with the EzPAP® device. We perform a prospective monocentric, open label trial.     Patients with atelectasis after scheduled cardiac surgery with cardiopulmonary bypass are     included. They benefit from manual chest therapy and are randomised to receive or not     positive end expiratory pressure sessions twice a day. The primary endpoint is the effect of     this treatment on atelectasis radiological score after 2 days of treatment. The secondary     endpoints are: oxygen saturation(SpO2)/inspired oxygen(FiO2) ratio, qualitative evaluation of     ventilatory function, respiratory & cardiac rate, pain, inspiratory pressure (sniff test),     patient satisfaction, duration of intensive care unit (ICU) and hospital stay.   "
78210|NCT02262169|"     This is a 2-arm, prospective, double-blind, double-dummy, randomized-controlled study using     DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), or omeprazole at     a dose of 40 mg once daily (before morning meal), for an 8-week course of therapy, for the     treatment of patients with any non-bleeding peptic ulcers.      DLBS2411 is a bioactive fraction of an Indonesian native herbal, Cinnamomum burmanii, locally     known as kayu manis have been proven at cellular and genetic levels to have an antiulcer     effect through both suppressing the gastric acidity and enhancing gastric mucosal protection.     The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase     'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing     gastric acid secretion; while its gastro-protective defense mechanism works through the     promotion of COX-2 derived prostaglandin (PgE2) synthesis, stimulating gastric-epithelial     mucous and bicarbonate secretion; anti-oxidative activity; and endothelial-nitric oxide (NO)     formation.      Recent study of DLBS2411 in healthy volunteers demonstrated the effective role and safety of     DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is     hypothesized to benefit in peptic ulcers.   "
78218|NCT02262065|"     Assessment of cytokine polymorphisms in 100 patients with aseptic complications to     arthroplasty as compared to 100 symptom-free arthroplasty patients.      In selected patients additional in-vitro cytokine release assay with peripheral blood     mononuclear cells (PBMC) stimulated with different wear particles.   "
78243|NCT02261740|"     The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat     pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report     persistent or recurrent pelvic or genital pain for at least 6 months that interferes with     sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility     criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel.     Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that     have been carefully selected for their potential to improve women's genito-pelvic pain and     practice yoga at home one additional hour a week.      The investigators will evaluate changes in the severity and impact of women's pain using     validated questionnaires and diaries.   "
78363|NCT02260180|"     The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of     A-101 versus a vehicle control in the treatment of seborrheic keratosis.   "
78219|NCT02262052|"     The Theia-study is a prospective, multicenter, single-arm management (cohort) study.      Consecutive patients with clinically suspected acute, recurrent, ipsilateral, proximal deep     vein thrombosis (DVT), who fulfil all the inclusion criteria and meet none of the exclusion     criteria, are eligible for inclusion and will be managed according to the result of a     magnetic resonance direct thrombus imaging (MRDTI) of the affected leg. The MRDTI is to be     performed and adjudicated within 24 hours of study inclusion. The final treatment decision     will be made based on this ruling of the MRDTI. In case of a positive MRDTI signal, patients     will be treated with therapeutically dosed anticoagulants. Patients with a negative MRDTI     ruling will be subjected to a standardized compression ultrasonography (CUS) within 48 hours     after initial presentation. The latter CUS serves as a reference test in case the patient     returns with symptoms of ipsilateral recurrence in the future, and will not be used for     management decisions at baseline. The study flowchart can be found in Appendix A.      All patients will be followed for three months for the occurrence of acute recurrent venous     thrombo-embolism (VTE). In case of suspected recurrent VTE, objective testing including     either computed tomography pulmonary angiography (CTPA) for PE or CUS for DVT will be     performed. Additionally, in case of a proven ipsilateral recurrent DVT during follow-up,     MRDTI will be repeated.   "
78220|NCT02262039|"     The purpose of this study is to determine if the Airseal System will reduce post-operative     pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.   "
78221|NCT02262026|"     Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and     Pavlovian-to-instrumental transfer (PIT), part II Saracatinib   "
78222|NCT02262013|"     Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the     feasibility of this dietary intervention strategy and preliminary effectiveness of two models     of parental involvement within adolescent obesity treatment.   "
78223|NCT02262000|"     This study will help researchers learn about the best dose of radiation to be used when     treating large early stage non-small cell lung cancer (NSCLC) with a treatment called     stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC     show positive response. But, for large early stage NSCLC it may be better to give different     SABR doses than what is used in routine early stage NSCLC treatment. It is not understood     which dose is best for treating large early stage NSCLC. Therefore, this study can help     researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can     increase the chance of cure for large early stage NSCLC.   "
78224|NCT02261987|"     This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed     previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus     clearance during a typical bronchial drainage session in adults, stable CF patients.   "
78225|NCT02261974|"     Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design      The objective of this study is to determine the safety and effectiveness of the Viveve System     to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving     vaginal laxity.   "
78226|NCT02261961|"     The loss of muscle mass and strength due to aging leads to serious health problems for older     adults. Muscle health can be improved by exercise training, but some people improve their     strength substantially, whereas others improve little. The reason for this variation is     unknown. This study will investigate whether function of the immune system influences how     well people respond to exercise. Older Veterans who participate will have their muscle size,     strength, and function measured periodically for almost a year. Participants will drink a     nutritional supplement or placebo daily and complete a 36 session strength training program.     Participants will be vaccinated for tetanus and donate small amounts of blood and muscle     tissue during the study so that immune function can be compared to muscle outcomes during     training and during a long-term follow-up. The study results should increase the     investigators' understanding of the negative effects of aging on muscle and will possibly     lead to better strategies for muscle maintenance and rehabilitation for older adults.   "
78227|NCT02261948|"     The present study was conceived to evaluate the effects of levosimendan on cardiopulmonary     exercise test (CPET) and DLCO ( Diffusion capacity of Lung for carbon monoxide) in patients     with severe heart failure in stable clinical conditions (NYHA - New York Heart Association -     class III, with a peak VO2 (Oxygen consumption ) < 12 ml/min/kg) on top of optimized standard     therapy.   "
78228|NCT02261935|"     In this project the investigators will train home care nurses to use the Carer Support Needs     Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then     compare the family caregivers' quality of life, burden and other outcomes to a group of     family caregivers whose home care nurse is not using the CSNAT (control group). Findings will     allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and     address family caregiver support needs in palliative home care.   "
78229|NCT02261922|"     To evaluate the effect of ticagrelor on endothelial function as measured by flow mediated     dilation of the brachial artery. This will be compared to prasugrel.   "
78230|NCT02261909|"     NephroCheck is measuring the concentration of a certain protein combination in the urine of     patients. In elevated values there is a probability of renal failure (already proven in     intensive care patients). The investigators would like to investigate whether the     investigators can predict renal failure in patients receiving contrast enhanced CT's in the     emergency department. That would lead to an earlier nephrologist consult in those patients.   "
78231|NCT02261896|"     The purpose of this study is to determine whether the use of antibiotic prophylaxis is     appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic     ultrasonography.   "
78232|NCT02261883|"     This pilot study aims to assess the safety and treatment effect of acute dosing with IV     Remodulin in neonates with persistent pulmonary hypertension of the newborn (PPHN).   "
78259|NCT02261532|"     The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after     single and multiple dose in Chinese patients with solid tumor.   "
78364|NCT02260167|"     Treating with measures that may improve metabolic functioning of neurons in an integrated     protocol   "
78365|NCT02260154|"     Prospective, multicenter, non-comparative, observational program designed to assess the     effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg BID and changes in quality of     life in patients with post-cholecystectomy gastro-intestinal spasms   "
78233|NCT02261870|"     The investigators propose a simple and non-invasive method to monitor heart transplant     patients with MRI. Its diagnostic and prognostic values have already been assessed in two     monocentric studies. Other monocentric studies based on related methods have confirmed the     investigators findings. These studies are insufficient to allow a large diffusion of the     technique. Only a large multi-centric study will change medical practices. In addition, this     project will spread the new method at a national level and will allow an assessment of its     practical usefulness in centres not familiar with MRI T2 quantification.      Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of     this observation could lead to a modification of diagnostic criteria of cardiac graft     rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on     biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient     and earlier detection of rejection. This would constitute a major advance in patients     security and comfort as well as an economic improvement.   "
78234|NCT02261857|"     The purpose of this study is to determine whether patient-specific computer-aided design     (CAD) and three-dimensional (3D) printing can be utilized to produce personalized, effective     continuous positive airway pressure (CPAP) masks for children with severe obstructive sleep     apnea (OSA) and craniofacial anomalies who encounter significant difficulty using CPAP     because of poorly fitting masks despite exhausting available commercial mask options.   "
78235|NCT02261844|"     The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a     beneficial effect in the cellular function of normal liver cells and diseased liver cells     (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based     on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement     will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation     of cancer cells, 3)decrease inflammation in the liver.   "
78236|NCT02261831|"     The investigators will compare 16sRDNA profile in cases and controls in order to identify     bacteria associated with metabolic diseases that reside both in intestinal crypts and in     blood.   "
78237|NCT02261818|"     Can peer mentors be integrated into depression care to older adults with mental health     professional supervision? We will assess whether peer mentors who are lay persons who are in     recovery from depression can provide depression care services to older adults with     depression. Older adults who are 50 and older will be screened for depression in the clinic     and community. Those who meet criteria will be paired with a peer mentor for 8 meetings. Peer     mentors will audiorecord their meetings with the patient and the recordings will be analyzed     to assess what kinds of communication and behaviors the peer mentors engage in and what among     those communications may be associated with relieving depression. The peer mentor will be     trained and supervised by a psychiatrist and they will form a team to provide the depression     care to the older adult. The study aims to relieve depressive symptoms and engage older     adults in care. Both older adults and peer mentors wil be interviewed after the study to     assess the strengths and weaknesses of peer mentor delivery of depression care. A manual will     be developed describing the process and procedures of the study.   "
78238|NCT02261805|"     This is a Phase I/safety dose expansion study of the combination of the drug ganetespib and     doxorubicin in patients with advanced solid tumors. The purpose of the Phase I part of the     study is to determine the recommended phase II dose of ganetespib when given in combination     with doxorubicin. The recommended Phase II dose determined at the end of the dose escalation     phase will be used to conduct a safety dose expansion phase in relapsed/refractory small cell     lung cancer to determine if there is a signal of efficacy in this population.   "
78239|NCT02261792|"     Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of     cerebrospinal fluid. There are not controlled studies for this treatment.The main of this     study is to demonstrate the superiority of the Trendelenburg position compared to supine     position during 24 hours after an epidural blood patch for a spontaneous intracranial     hypotension   "
78254|NCT02261597|"     The main purpose of this study is to understand how insomnia (compared to good sleep) may     affect the response of the body to a repeated physiological challenge, such as inserting the     hand in ice-cold water for several times in a row. In particular, the investigators are     interested in the response of markers that can be associated with stress, such as blood     pressure and stress hormones.   "
78255|NCT02261584|"     The aim of this study is to compare microwave thermal coagulation and partial splenic     embolization in the management of hypersplenism in patients with cirrhosis.      This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly     and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine     Research Institute.   "
78778|NCT02254707|"     To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg,     40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW     administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS)     drinking solution for five days to patients with chronic HCV genotype 1 infection   "
78240|NCT02261779|"     Longterm disease-free survival (DFS) of older patients with acute myeloid leukemia (AML)     remains poor. The vast majority of AML patients relapses within two years after start of     therapy1,2. In Acute Promyelocytic Leukemia (APL, AML M3), all-trans-retinoic-acid (ATRA;     Tretinoin) induces differentiation and subsequently clinical remission. So far effective     differentiation therapy does not exist in other AML subtypes. Recent preclinical data suggest     that the combinatorial use of ATRA and tranylcypromine (TCP), an irreversible     Monoamine-Oxidase (MAO) and Lysin-specific demethylase (LSD) inhibitor that also inhibits     LSD1 (a histone H3 Lysine 4 demethylase), induces leukemia cell differentiation and leukemic     stem cell exhaustion in vitro and in vivo in non-APL AML subtypes.      In this Phase I/II study the investigators will explore the feasibility, safety, as well as     efficacy and of Tretinoin/TCP treatment in patients with relapsed or refractory AML or in     patients with AML who are not eligible for intensive treatment. Patients will be treated with     daily increasing doses of TCP (initially 10 mg/day, then +10 mg each day up to 80mg/d). After     7 days, ATRA will be added at a fixed dose (45 mg/sqm/day). Overall, 16 evaluable patients     are going to be treated. The primary endpoint is the fraction of patients that achieve CR,     CRp( complete response with incomplete recovery of platelets), CRi (complete response with     incomplete recovery of granulocytes) and PR. Secondary endpoints are tolerability, safety as     well as progression-free survival and overall survival. Serum levels of TCP will be regularly     analyzed. Pharmacodynamic analyses will be performed with analyses of the inhibition of LSD1     by TCP. Further analyses will address the changes in Histone H3 lysine 4 tri demethylase     (H3K4me3) levels in AML blasts and the differentiation status of AML blasts.      Taken together, this Phase I/II study will analyze feasibility, pharmacodynamics and     effectivity of ATRA and TCP as differentiation therapy in AML.   "
78241|NCT02261766|"     This study will compare the two methods 5 days holtermonitoring and 30 days thumb     electrocardiogram for detection of atrial fibrillation in stroke patients   "
78242|NCT02261753|"     The investigators are undertaking the first European Randomised Controlled Trial (RCT) for     epilepsy surgery in children with FCD type II, to prospectively evaluate the role of the KD     prior to surgery in improving seizure outcome. The investigators will evaluate the role of KD     as a disease-modifying treatment to achieve seizure control and improve neurodevelopment and     quality of life. Children age 5 - 15 years with pharmacoresistant epilepsy believed to be the     result of focal cortical dysplasia type II, considered to be surgically treatable, will be     randomised to either receive 6m treatment presurgery with a ketogenic diet, or to proceed     direct to surgery (no pretreatment). Primary outcome will be the time to achieve a period of     6 months of seizure freedom from the date of randomisation. Tissue resected at surgery will     also be evaluated with regard to the degree of any methylation of DNA.   "
78366|NCT02260141|"     To study the effectiveness of d-ribose in treating Alzheimer's and Dementia   "
78244|NCT02261727|"     The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess     the effect of low dose theophylline, singly and in combination with low dose oral prednisone,     on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary     clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment.     Approximately 2400 symptomatic patients with COPD will be recruited in China for comparison     of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The     primary end-point for this study is the difference between the three treatment groups in        -  COPD exacerbation rate        -  Time to first severe exacerbation requiring hospitalisation or death   "
78245|NCT02261714|"     The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage     colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and        -  Understand any possible side effects of the additional use of TG01/GM-CSF with          gemcitabine        -  Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune          response        -  Investigate if the treatment can delay or reduce recurrence of the disease   "
78246|NCT02261701|"     A new postoperative regimen with a new bandage technique after surgery results in a better     shoulder function and quality of life after surgery - than traditional postoperative regimen     with shoulder lock and abductor cushion.   "
78247|NCT02261688|"     The overall goal of this study is to evaluate the association between sodium and TH17 cells     in human subjects. The subjects will have levels of TH-17 and various hormones measured on     low salt diet, low salt diet with intravenous normal saline, and high salt diet.   "
78248|NCT02261675|"     The study was designed to define the interaction of intravenous infusion of dexmedetomidine,     an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum     alveolar concentration which can block adrenergic and cardiovascular responses to     incision(MACbar) of sevoflurane as the measure of anesthetic potency.   "
78249|NCT02261662|"     This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV     infection. The study will be done at Tropical medicine department , Tanta university. It will     be conducted between June2014 and November 2014.      The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous     extrahepatic manifestations of HCV infection.   "
78251|NCT02261636|"     For both induction of remission and in maintenance of remission, different doses and     treatment durations are used in practice. The aim of this study is to assess how mesalazine     is used in clinical practice, at which doses and for how long and how these differences     impact the patient disease state and work productivity.   "
78252|NCT02261623|"     The purpose of this study is to document stent functionality and practice patterns in Canada     pertaining to indications for use and stent type selection for self-expanding biliary metal     stents (SEMS) when used per standard of practice.   "
78253|NCT02261610|"     The clinical manifestations of pulmonary embolism vary greatly from the absence of specific     clinical symptoms to cardiogenic shock or cardiac arrest. Clinical form of EP represented by     lung superinfection, also called pulmonary embolism superinfected is common and     represents up to 30% of initial clinical presentations; she been few evaluations in clinical     research. The reality of the bacterial infection remains controversial and the clinical     presentation often leads to the prescription of empirical antibiotic therapy, often     unnecessary in many cases. Number of antibiotic prescriptions are probably inappropriate.      Fever has long been recognized as a sign associated with pulmonary embolism. Stein et al     reported a temperature above 37.5 ° C on 50% of patients with acute pulmonary embolism     without actually clarified whether this was related to temperature with a pulmonary embolism     or other associated cause. Murray et al estimated that greater than 38 ° C was explained by     pulmonary embolism in 57.1% of patients while in the PIOPED study, only 14% of patients had     fever with no other cause identified as pulmonary embolism. Fever due to pulmonary embolism     is often low intensity (often less than 38.3) and of short duration, with a peak on the day     of pulmonary embolism and a gradual decrease of about 1 week. The pathophysiology of fever in     pulmonary embolism has not yet was completely clarified. It is suggested that a combination     of several factors involved pyrogenic myocardial tissue necrosis and releasing     pro-inflammatory cytokines, hemorrhage, vascular irritation or inflammation, atelectasis or     local superinfection.      Since 2004, the PCT has become a marker helping the initiation of antibiotic therapy in     patients with community-acquired pneumonia. This is especially verified in patients admitted     for acute exacerbation of chronic obstructive bronchitis. In the latter case, the use of PCT     reduces inappropriate antibiotic prescribing. Thus helping the clinician by measuring     biomarkers such as PCT is based on writing an algorithm leading or not to use antibiotics.      The use of an algorithm involving the PCT could just as for infectious pneumonia or COPD, of     interest in the febrile pulmonary embolism to distinguish febrile forms related to bacterial     infections febrile forms of EP to other causes.   "
78256|NCT02261571|"     Most cancer patients experience multiple symptoms related to chemotherapy and use CAM     (complementary and alternative medicine) as an adjunct to conventional treatment. Moxibustion     is traditional Korean medical therapeutic method and uses the heat generated by burning     herbal preparations containing Artemisia vulgaris to stimulated acupoint.      Herein, the investigators propose an open-label pilot study investigating the effectiveness     of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under     chemotherapy.   "
78257|NCT02261558|"     This study will investigate the impact of music therapy on newly diagnosed patients with     cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle     will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety     depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis     Scale).   "
78258|NCT02261545|"     The aim of this study is to determine the effects of supplementation with n-3 fatty acid or     placebo for 10 weeks on the expression of Sirt-1, AdipoR1 & AdipoR2 genes in the peripheral     blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of     type2 diabetes patient   "
78260|NCT02261519|"     The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in     improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy     Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a     multi-center, prospective, randomized, placebo-controlled, in which adult subjects with     schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a     4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension     part.   "
78261|NCT02261506|"     Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although     bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most     commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin and     soft tissue sources), because of the high attendant morbidity and mortality of bacteremia,     these patients collectively represent a critically important group to study.      The consequences of the excessive antimicrobial use for individual patients, range from rash,     gastrointestinal upset and diarrhea, to anaphylaxis, neutropenia, renal failure, toxic     epidermal necrolysis, death, and a marked increase in ICU and hospital drug costs. One     particularly concerning complication, Clostridium difficile infection, has increased in     incidence and severity over the past decade. Much of this burden could be prevented through     reduction in unnecessary antibiotic use.      Another major consequence of excessive antibiotic use is antimicrobial resistance. Antibiotic     resistance is not only a concern for the patient who receives antibiotics, but also for     neighbouring patients in the ICU, as well as future patients in the ICU and the hospital at     large - through patient-to-patient transmission, and environmental contamination.      No previous randomized controlled trials have directly compared shorter versus longer     durations of antimicrobial treatment in these patients. The investigators will conduct a     multi-center randomized concealed allocation trial of shorter duration (7 days) versus longer     duration (14 days) antibiotic treatment for critically ill patients with bacteremia admitted     to ICU. Eligible, patients will be randomized to either 7 days or 14 days of adequate     antimicrobial treatment. The selection of type, dose and route of antibiotics will be at the     discretion of the treating physicians, but the duration of treatment (7 versus 14 days) will     be determined by randomization group. The randomization assignment will not be communicated     to the study research coordinator, study critical care or infectious diseases investigators     or clinicians until day 8. The primary outcome for the main trial will be 90-day mortality.      The study will be initiated at Sunnybrook Health Sciences Centre in Toronto, Ontario, and     then rolled out to a second site at Kingston General Hospital in Kingston, Ontario. These     sites will be sufficient to meet the sample size goals for the pilot RCT, but if additional     funds are obtained the investigators will also roll out to the other Canadian ICUs listed     below. The goal of adding these additional sites will be to increase the generalizability of     the findings with respect to trial feasibility   "
78262|NCT02261493|"     This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial     rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).   "
78263|NCT02261480|"     Parvovirus B19 is a small virus that is the cause of fifth disease, a common infection in     childhood. In people with sickle cell disease (SCD), parvovirus B19 infection causes the bone     marrow to stop producing red blood cells temporarily, which can be life-threatening. A novel     vaccine is currently in development for children with SCD. This study is the first step     within a larger parvovirus B19 multi-institutional project that will help develop this new     vaccine, as it will define the value and utility of using a novel assay for measurement of     parvovirus-specific antibodies. The main objective is to investigate the relationship between     the newly developed VP1u ELISA assay and the gold standard neutralization assay for     parvovirus B19 infection.      The most accurate test, called a neutralizing antibody assay, to see if a person has had or     currently has the infection is very complex and expensive and would be very difficult to use     in a large research study to test the new vaccine. A new and simpler test has developed. The     main goal of this study, iSCREEN, is to find out if this new test works.      There will be distinct labs performing the VP1u ELISA and the neutralization assays and the     respective laboratories will not have access to each other's results for individual subjects.     The VP1u ELISA will be performed at St. Jude Children's Research Hospital. Neutralization     assays will be conducted at the National Heart, Lung and Blood Institute.   "
78264|NCT02261467|"     This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and     glabellar facial rhytides (frown lines).   "
78265|NCT02261454|"     Traditional postoperative care has been challenged recently to improve and speedup recovery     (including the return of bowel function) such that patients can be discharged to home more     quickly. This approach includes earlier mobilization of the patient, and introducing solid     food sooner. Additionally, there is evidence in adults to suggest that sham feeding by     chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet     earlier.      The aim of this study is to determine if gum chewing can enhance bowel recovery in children     who undergo abdominal surgery.   "
78266|NCT02261441|"     IBERICAN is a multicenter, longitudinal and observational population-based study of patients     daily attended in Primary Care setting in Spain.      This study is aimed to determine the prevalence and incidence of cardiovascular risk factors     in adult population in Spain.      Patients will be followed-up for a minimum period of 5 years, every 6 months or a lesser     period when clinically required.      It has been estimated that a total of 15,000 individuals will be included.   "
78267|NCT02261428|"     The study compares the effectiveness of Tiemann and Suction catheters, with regard to     attempts to enter the trachea and the time required for the procedure.   "
78380|NCT02259959|"     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and     Tiotropium Bromide when given as fixed dose combination   "
80542|NCT02231684|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of     three different strengths of semaglutide and the absolute bioavailability of semaglutide.   "
78268|NCT02261415|"     This is a multicentre Vanguard randomized controlled trial (RCT) to evaluate the impact of     tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver     resection. The rationale for this study includes: (1) experimental evidence supporting the     use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver     resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons,     anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient     study design; and (5) the importance of the question: incidence of blood transfusion in     patients undergoing liver resection is high, and the consequences serious. Different regions     of Canada are well represented in the selection of study sites and five major sites have     committed to participate in the Vanguard trial: Sunnybrook Health Sciences Centre (Toronto),     University Health Network (Toronto), Foothills Medical Centre (Calgary), McGill University     Health Centre (Montreal), and Queen Elizabeth II Health Sciences Centre (Halifax). We will     enroll 200 patients in this Vanguard study. This Vanguard study will assist us in determining     the feasibility and planning of a definitive multicentre RCT across Canada. If the Vanguard     study confirms feasibility, we will expand the trial to additional sites and proceed directly     into the definitive trial (planned sample size = 1230 patients). The following is a brief     schema and study outline of the trial.   "
78389|NCT02259842|"     Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in     healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of     food effect by re-dosing at 50 mg and 150 mg   "
78269|NCT02261402|"     Medisinstart is a new service developed for use in Norwegian pharmacies. It is intended for     patients that are about to start a new medicine for a chronic or long-term condition. It is     based on research showing that problems with newly prescribed medicines appear rapidly and     that a significant portion of patients quickly becomes non-adherent. The service consists of     two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5     weeks after start of the new medicine.      The main purpose of this study is to investigate whether Medisinstart increases patients'     adherence to the prescribed medication. Patients' beliefs about their medicines and their     motivation for adherence will also be examined. The study also aims at revealing if     Medisinstart has additional benefits for the patient, the society and the pharmacies.   "
78270|NCT02261389|"     The main purpose of follow-up in asymptomatic breast cancer patients during and after     adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of     this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and     CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical     increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local     and distant recurrence compared to the usual follow-up practice.   "
78271|NCT02261376|"     This is an open label, non-randomised, single-dose, parallel-group study in 48 healthy     subjects enrolled in 4 cohorts - Caucasian men, aged 18-55 years, Caucasian men, aged 65     years or older, Japanese men, aged 18-55 years, Caucasian women, aged 18-55 years.   "
78272|NCT02261363|"     The universe of tobacco products is expanding, with new noncombustible products gaining     popularity even as the reduction in prevalence of cigarette smoking slows or stalls.     E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of these     emerging noncombustible products. With sales increasing rapidly and more efficient pulmonary     delivery devices under development, ENDS are likely to play an increasing role in the future     tobacco market. Little is known about the cognitions and behaviors leading to or sustaining     ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce perceived smoking     harms, or for smoking cessation. Evidence about ENDS use is emerging from national     surveillance and laboratory research, but the majority of information on ENDS is limited to     retrospective surveys and convenience samples of White male ENDS users. The investigators     research suggests Black smokers are less likely than White smokers to try and be current ENDS     users, perhaps due to a greater degree of perceived harm associated with ENDS, a preference     for menthol, or cultural norms. Thus, it is timely and critical to study how all smokers,     including Blacks and menthol smokers, experience and initiate ENDS use employing valid,     innovative research methods.   "
78273|NCT02261350|"     To determine the feasibility of delivering different community nutritional interventions to     chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of     malnutrition following a hospitalisation for an acute exacerbation of COPD.   "
78274|NCT02261337|"     This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia     predict mortality in patients with chronic respiratory disease.   "
78275|NCT02261324|"     This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing     primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to     assess whether this can predict future cardiovascular events and death.   "
78276|NCT02261311|"     The investigators will compare the differences in the scores between the baseline     questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II     patients that enrolled in pre-treatment trials versus those that don't.   "
78277|NCT02261298|"     The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and     efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors     who are refractory or intolerant to standard therapy or for whom no appropriate treatment is     available.   "
78278|NCT02261285|"     The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to     Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to     standard therapy or for whom no appropriate treatment is available.   "
78279|NCT02261272|"     The study will test an internet-based treatment for insomnia.   "
78280|NCT02261259|"     The overall goal of this project is to develop sensitive and objective clinical research     tools for the assessment of head-neck motor control. In order to accomplish this goal, the     investigators aim to quantify changes in head-neck motor control before and after osteopathic     manipulative treatment. The investigators hypothesize that head-neck motor control will     improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators     will compare position and force head-neck motor control between healthy controls and neck     pain patients. The investigators hypothesize that baseline tests of position and force     head-neck motor control will be better in healthy individuals than neck pain patients.   "
78281|NCT02261246|"     The overall goal of this project is to develop sensitive and objective clinical research     tools for the assessment of trunk motor control. In order to accomplish this goal, the     investigators aim to quantify changes in trunk motor control before and after spinal     manipulation treatment. The investigators hypothesize that trunk motor control will improve     in the low back pain participants after 4-weeks of spinal manipulation treatment.     Additionally, the investigators will compare position and force trunk motor control between     healthy controls and low back pain patients. The investigators hypothesize that baseline     tests of position and force trunk motor control will be better in healthy individuals than     low back pain patients.   "
78296|NCT02261051|"     Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is     the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent     Control Study). The primary aim of the study is to compare the proportion of advanced cancer     patients who have a hospitalization or emergency department visit in the last 6 months of     life before and after implementation of a new care model that provides more comprehensive     symptom management and supportive care, including earlier referral to palliative care. The     secondary comparative aim is to assess measures of quality of life and satisfaction in both     groups. This current study is to collect data on the control group only. After system     redesign, we will open an intervention arm study to collect data after implementation of the     new care model (about 18-24 months from start of control phase).   "
78282|NCT02261233|"     The overall goal of this project is to develop sensitive and objective clinical research     tools for the assessment of postural control of the trunk. In order to accomplish this goal,     we aim to quantify balance performance in an unstable seated task. Specifically, the     investigators will quantify balance performance in low back pain participants before and     after osteopathic manipulative treatment. The investigators hypothesize that there will be a     significant improvement in balance performance after a single session of osteopathic     manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and     this improvement will be greater than any learning effect.      A secondary objective of this study is to quantify differences in patient-oriented outcome     measures (e.g., self-reported pain, disability) in low back pain participants before and     after osteopathic manipulative treatment. The investigators hypothesize that there will be a     significant improvement in these self-reported outcomes following osteopathic manipulative     treatment. The association between improvement in postural control parameters and     patient-oriented measures will also be explored.   "
78283|NCT02261220|"     This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the     safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination     with tremelimumab in subjects with select advanced solid tumors.   "
78284|NCT02261207|"     This is an investigator initiated, open label, prospective, non-randomized, phase II trial     aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive     advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally     reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive     advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice a     day, continuously. Treatment will be continued till evidence of progression, or toxicities or     patient withdrawal.   "
78285|NCT02261194|"     The purpose of this trial is to determine the short-term effect of a self-care intervention     on depression in patients with age-related macular degeneration or diabetic retinopathy.   "
78286|NCT02261181|"     There is a strong need to study products with a preemptive role in radiation dermatitis     development, with a trial design taking in account patient subjective evaluation and     compliance.      XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical     gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and     pruritus, induced by radiotherapy or other causes.   "
78287|NCT02261168|"     This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism     in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a     standardized living protocol during which several measurements of skeletal muscle and whole     body energy metabolism will be performed.   "
78288|NCT02261155|"     Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory     testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic     susceptibility will be assessed before QST.      QST data before and during hypnosis will be compared. Observed sensory changes will be     evaluated in relation to the assessed hypnotic susceptibility   "
78289|NCT02261142|"     Spasticity is a common consequence of injury to the central nervous system and can be a major     problem in motor function and everyday activities. A method for treating spasticity that     applies low-amplitude electrical stimulation through a garment with built-in electrodes,     Mollii® (Elektrodress), has been developed. The garment is to be used in combination with     individualized training and the stimulation is mainly given to antagonists of spastic     muscles.      The general objective of this study is to evaluate the efficacy of and costs associated with     the Mollii® treatment of spasticity due to stroke or cerebral palsy.      Primary objectives are;        -  to study whether treatment with the Mollii® improves function and activity        -  to evaluate the cost-effectiveness of the treatment, from both a health-care perspective          and a societal perspective.      Secondary objectives are;        -  to study whether there are differences in treatment effect between the stroke and the          Cerebral Palsy groups in a subgroup-analysis        -  to assess compliance with treatment        -  to report any adverse effects.   "
78290|NCT02261129|"     Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two     tablets of the telmisartan 40 mg conventional tablet   "
78291|NCT02261116|"     Study to assess potential different properties of telmisartan, which due to its Vd, should     result in stronger beneficial effects of AT1 blockade in tissues (e.g. aldosterone     suppression and renin increase) plus stronger AT2 stimulation compared to candesartan   "
78452|NCT02259023|"     Purpose:      The objective of this study is to determine the effect different sources and forms of     discretionary foods have on stress perception in healthy adults in a free living, real world     setting.      Rationale:      The rationale for conducting this study is to test the effects of sugar-sweetened beverages     and grain-based desserts have on perceived health and stress perception, since the evidence     for this topic is limited.   "
78292|NCT02261103|"     The objectives of the studies are:        -  To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER          fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal          any food effect leading to uncontrolled release        -  To investigate the relative bioavailability of the ER-formulation of pramipexole in          comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple          dosing        -  To demonstrate dose proportionality between the dose strengths of the pramipexole ER          formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing   "
78293|NCT02261090|"     Study to compare the oral bioavailability of seven prototype slow-release formulations to     immediate-release tablets   "
78294|NCT02261077|"     Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single     rising dose and after multiple rising doses   "
78295|NCT02261064|"     Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose     combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg)     in the fed condition compared with those of the same fixed-dose combination in the fasting     condition in healthy Japanese male volunteers.   "
78297|NCT02261038|"     Femoral component rotation in total knee arthroplasty (TKA) has been considered an important     factor for outcome. However, measurement of femoral component rotation is difficult to     perform.      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),     axial CT slices and 3D reconstructed CT images.      It was the hypothesis that measurements on radiographs are comparable to measurement on CT     images.      Measurements of femoral TKA rotation will be measured three times by three different     observers and inter- and intraobserver reliability is calculated. The absolute values of each     measurement method is noted in degrees.   "
78299|NCT02261012|"     This study aims for a better understanding of the pathophysiological mechanisms of the     complex regional pain syndrome (CRPS). This will be done by testing the quantitative sensory     testing, the remote ischemic conditioning, the conditioned pain modulation (CPM) and the     analysis of the heart-rate variability in patients with CRPS and a control-group. We     hypothesize decreased conditioned pain modulation, less effects of remote ischemic     conditioning and an affection of the heart-rate variability in patients with CPRS.   "
78300|NCT02260999|"     In this study, the detection of the feigning weakness in grip strength is measured using     different grip strength testing instruments. Patients with injury of the upper limb are     compared to patients with injury of the lower limb as well as healthy controls.   "
78301|NCT02260986|"     The purpose is to demonstrate efficacy and long term safety of dupilumab in combination with     topical corticosteroids in patients with moderate to severe AD.   "
78302|NCT02260973|"     This is a randomized, masked, placebo controlled study to assess the effect on visual acuity,     if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.   "
78303|NCT02260960|"     The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye     related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity,     Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared     to administration of placebo.   "
78304|NCT02260947|"     This study will examine the activity of 2 different doses of PF-06273340 on a panel of evoked     pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects   "
78305|NCT02260934|"     In this experimental study, researchers will try to find out if treatment of lupus nephritis     with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and     CTX followed by treatment with belimumab is safe and if this drug combination can block the     immune system attacks.   "
78306|NCT02260921|"     This purpose of this study is to evaluate the effectiveness and safety of the iovera° device     for the temporary reduction of pain associated with knee osteoarthritis.   "
78307|NCT02260908|"     Victims of trauma with severe head injury who have bled into their brains are at high risk of     developing blood clots in their legs. These blood clots can break off and travel through the     bloodstream to the lungs, resulting in death. Blood thinners can be given to patients to     prevent blood clots from developing but this can leave patients at risk for additional     bleeding in the brain, causing further damage or death. The earlier blood thinners are     started, the more effective they are at preventing blood clots. In addition, some patients     with severe head injury who have bled into their brains will develop further bleeding even if     they do not receive blood thinners. Even though a growing body of research has shown that the     majority of bleeding in the brain stops within the first 24 hours after injury and that it is     safe to start blood thinners as early as 24 hours after injury, doctors are still waiting     longer than 4 days to start blood thinners in these patients over concerns of worsening     bleeding. In Canada, almost half of the patients with severe head injury do not receive blood     thinners until at least five days after injury. Delays in starting blood thinners appear to     put patients at increased risk of developing blood clots, unnecessarily. This study will     compare the benefits of starting low-molecular-weight heparin (LMWH), a type of blood     thinner, early (36 to 48 hours after injury) versus the current practice (waiting until the     6th day after being injured) in preventing blood clots in patients who have bled into their     brains after severe head injury. The investigators believe that starting LMWH earlier will be     more effective in preventing blood clots without worsening any bleeding when compared to     waiting to start blood thinners. This study is called OPTTICH (OPtimal timing of     Thromboprophylaxis in Traumatic IntraCranial Haemorrhage) and will be the largest Canadian     investigator-initiated randomized control trial on blood clot prevention in trauma patients     with severe head injury who have bled into their brains.   "
78308|NCT02260895|"     Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an     important goal. The progression from impaired glucose tolerance to diabetes is thought to be     promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main     defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is     reduced first phase (immediate) insulin release. The investigators hypothesis is that     consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes     before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent     carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.      The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour     oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose     tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of     dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak     of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the     timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).      The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40     mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour     glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to     show a statistically significant difference between the almond pre-test snack and control     standard OGTT conditions.   "
78309|NCT02260882|"     The purpose of this study is to determine if revaccination with pneumococcal vaccine     (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese     adults. The primary hypothesis being tested is that the geometric mean concentration of     antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after     revaccination will be superior to that before revaccination in Japanese adults who received a     primary vaccination at least 5 years before revaccination.   "
78310|NCT02260869|"     This is a single center randomized controlled trial. Approximately 102 patients will be     randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar     radiofrequency ablation. Patients with chronic knee pain, with moderate to severe     osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed     conservative therapy will be screened for the study.      Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic     guided single diagnostic block of the geniculate nerves (superior medial, superior lateral,     and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).      Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4,     12, 24 and 52 weeks.      Outcome measures will be: Visual analogue scale (VAS) both while at rest and during     ambulation, Oxford knee scores, WOMAC, and global perceived effect.   "
78332|NCT02260583|"     Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase     of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term     noninvasive mechanical ventilation (NIV) has been proposed.      Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not     always well tolerated and therefore it may be effective only in a subset of patients The aim     of this study is to assess the feasibility and safety of one shot extrcorporeal CO2 removal     device, in reducing the PaCO2 level   "
78311|NCT02260856|"     This is a randomized clinical trial of epiphysiodesis techniques: percutaneous transphyseal     screw epiphysiodesis versus percutaneous drill epiphysiodesis for the correction of leg     length discrepancy. Failed epiphysiodesis was selected as the primary outcome. Failed     epiphysiodesis was defined as one or more of the following: development of angular deformity     > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected. EOS, low dose biplanar     X-Ray, will be used to make all length measurements. Secondary outcomes assess mean growth at     the physis following epiphysiodesis, in the subset of patients with bead implantation,     fluoroscopy and operative times, length of stay, return to full weight bearing, as well as     functional and quality of life outcomes. The following outcome scales will be used to measure     pain (VAS), quality of life (PROMIS Pediatric Pain Interference Scale), and function (PROMIS     Pediatric Mobility Scale, Pedi-FABS, and UCLA Activity Score). Each of these scales has been     validated for use in children (Beyer, Denyes, & Villarruel, 1992; DeWitt et al., 2011;     Fabricant et al., 2013; Novais et al., 2014; Varni et al., 2010a). We will also determine the     cost associated with each technique and perform a cost-effectiveness analysis to establish     which technique is preferred from a societal perspective.   "
78312|NCT02260843|"     Elderly insomnia is a serious public health problem. Current conventional approaches for     treating insomnia are not suitable or effective in elderly population. It has been previously     demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in     older adults and has been preliminarily demonstrated to improve sleep in older people. This     project aims to evaluate the efficacy of Tai Chi training on alleviating chronic insomnia in     older adults.   "
78313|NCT02260830|"     The purpose of this study is to investigate the pharmacokinetic (PK) properties of various     modified release tablet formulations of Lu AF11167 (Part A) and to investigate the     pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a     fed and fasted state and following multiple dosing (Part B).   "
78314|NCT02260817|"     This Phase 3 study will target approximately 100 men over age 18 who have a biochemical     relapse or other evidence of relapse of prostate cancer after primary treatment.      The purpose of this study is to:      A. Provide expanded access the drug 11C-choline.      B. Determine the performance characteristics (sensitivity, specificity, positive predictive     value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and     PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in     patients with biochemical relapse of prostate cancer after primary treatment in a prospective     manner.      C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT     and PET/MRI positive patients through a prospective study.      D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a     multivariable analysis of clinical and pathologic data collected prospectively.      E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline     PET/MRI and the combination of 11C-choline PET/CT and PET/MRI      Study Protocol:        1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.        2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.        3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic          prostate cancer.        4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with          biopsy or surgical pathology when possible, or by response to treatment on subsequent          imaging.        5. Rates of confirmed metastasis between conventional CT and MRI images will be compared          with the 11C-choline PET CT and MRI images.        6. Upon conclusion of each imaging protocol, the referring physician will receive written          documentation of the results. At this time, the patient will be considered off study and          no further follow up is required.   "
78315|NCT02260804|"     To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by     overall response rate at 7 months   "
78316|NCT02260791|"     The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison     to Humira® in rheumatoid arthritis patients who have inadequate disease control on     methotrexate.   "
78317|NCT02260778|"     The purpose of this study is to determine if a Learning Collaborative is an effective tool to     improve adoption and adherence to a Treat-to-Target (TTT) treatment strategy in U.S.     rheumatology practices for the treatment of Rheumatoid Arthritis (RA). The TTT strategy has     been embraced by the American College of Rheumatology through the RA Treatment Guidelines and     by EULAR,however several lines of evidence suggest that TTT is not practiced consistently     across rheumatology settings.Participating practices will be randomized to receive the     Learning Collaborative intervention in one of two phases. Coaching consistent with Learning     Collaborative practices will be used to promote adherence to TTT. Chart abstraction will be     used to determine if the Learning Collaborative was an effective tool to increase TTT     adherence.   "
78381|NCT02259946|"     Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg,     20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for     doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744     CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the     pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their     dose proportionality, and to explore the pharmacodynamic effects of the treatments on     selected metabolic and respiratory parameters   "
78318|NCT02260765|"     The aim of the study is to evaluate the efficacy of the Deep TMS compare to TAU and the     different in resource utilization of treating depression with Deep TMS compare to the TAU.      The current study is a prospective semi-naturalistic, randomized study in which depressed     patient who failed to respond to at least one medication or could not tolerate at least two     antidepressants and are seeking for alternative treatment will be offered to join an open     label study. The study designed as double arm study of which patient will have 50% chance to     be randomized to one of the study groups.      The study includes two arms. The dTMS study group will be treated according to the cleared     FDA treatment protocol of 4 weeks of daily treatment following by additional 12 weeks of     biweekly treatment and overall of 44 treatments. The Treatment As Usual arm will be treated     by their primary care physician / psychiatrist according to the usual treatment recommend to     the patient clinical status   "
78319|NCT02260752|"     The overall goal of this project is to better enable patients with uterine fibroids (UF) to     make informed decisions about treatment options by leveraging the highest possible evidence     of healthcare quality. The foundation of this project will be a multi-site, prospective     registry of a diverse group of women who have undergone either medical or surgical treatment     for UF.      Specifically, the investigators are interested in: comparing management options for symptom     relief; comparing management options for preserving reproductive function; and comparing     effectiveness among different subpopulations, including consideration of patient needs and     preferences of treatment options.   "
78334|NCT02260557|"     The primary objective of the study is to determine the activity of selexipag on Raynaud     attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis     (SSc).   "
78390|NCT02259829|"     Study to demonstrate the bioequivalence of 40 mg telmisartan / 5 mg amlodipine fixed dose     combination vs. its monocomponents   "
78320|NCT02260739|"     Recent advances in hematology clearly illustrate that the simple clonal nature of various     hematological malignancies may not really reflect the reality of malignant cells natural     expansion. This has been nicely illustrated in recent works in AML for example where     subclones coexists in the same patient at the same time, but could also differentially expand     over time because of effects of therapeutics intervention, but also by oncogenic spontaneous     events (1).      These observations have been done recently because of next generation sequencing that allows     to discriminate in the same tumor samples, different subclones and to analyse the clonal     architecture. Sequential analyses could help us to identify the first oncogenic event and to     correlate disease progression to the emergence of subclones.      For all these reasons it is of a major interest to precisely understand the architecture of     the clone in MPNs, especially to understand which is the initiating event and how from this     initial event the clone develops.      In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely     effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN,     but may favor the development of other malignant hemopathies.   "
78321|NCT02260726|"     Hip impingement is thought to be a leading cause of hip osteoarthritis, and occurs due to     deformities in the hip joint. However some individuals have these deformities but do not     exhibit symptoms. Using the standard magnetic resonance imaging and clinical tests it is not     clear which deformities will cause degeneration, requiring surgical intervention. We propose     to evaluate the deformity and impingement between the femur and acetabulum using dynamic     ultrasound imaging. Ultrasound does not involve radiation and can acquire video of the hip     joint and is thus suitable for such diagnostic purposes. In this pilot study we will evaluate     the feasibility of ultrasound in diagnosing hip impingement.   "
78322|NCT02260713|"     Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and     feasibility of autologous bone marrow cell transplantation in case of acute complete spinal     cord injury by each of the following techniques and a corresponding number of controlled     subjects:        -  Directly into the injured site with a syringe after exposing the spinal cord.        -  By Intrathecal injection.   "
78323|NCT02260700|"     The purpose of this study is to determine pharmacokinetics (the study of the way a drug     enters and leaves the blood and tissues over time) and the relative-bioavailability (the     extent to which a drug or other substance becomes available to the body) of JNJ-54861911     solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy     older male participants.   "
78324|NCT02260687|"     The objectives of this study are to investigate the safety and effectiveness of EYLEA.   "
78325|NCT02260674|"     The purpose of this study is to evaluate the long-term safety and tolerability of     JNJ-54861911 during 6 months of treatment in participants with early (predementia)     alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious     onset of dementia, impairment of memory, judgment, attention span, and problem solving skills     are followed by severe apraxias and a global loss of cognitive abilities]).   "
78326|NCT02260661|"     First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is     administered as a single agent in a multiple ascending dose escalation phase to investigate     dose level for monotherapy. Part B follows the multiple ascending dose phase, additional     patients with tumors with documented PIK3CA gene mutation will be enrolled to a single dose     expansion phase. Part C is a second dose escalation phase in which post-menopausal patients     with estrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in     combination with fulvestrant. Part D follows the combination dose escalation phase of the     study, additional postmenopausal patients with ER+/HER2 negative breast cancer with     documented PIK3CA gene mutation will be enrolled to a AZD8835 and fulvestrant combination     dose-expansion phase at maximum tolerated dose or recommended phase II dose.   "
78327|NCT02260648|"     The main purpose of this study is to evaluate the efficacy and safety of the study drug known     as evacetrapib when administered in combination with atorvastatin for 12 weeks in Japanese     participants with primary hypercholesterolemia.   "
78328|NCT02260635|"     The main purpose of this study is to evaluate the efficacy and safety of the study drug known     as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind     treatment period will last for 12 weeks and the open-label extension period will last for an     additional 40 weeks.   "
78382|NCT02259933|"     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated     dosing   "
78329|NCT02260622|"     Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop     critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.     CLI results in resting pain, ulcers, gangrene, and limb loss. The outcome for patients with     CLI is poor. Within 3 months of onset, 12% of patients will require an amputation (removal of     part of the limb) and 9% will die of major cardiovascular events (heart attack or stroke).     Percutaneous angioplasty (PTA), a procedure used to open the blockages in blood flow, has     become the first-line treatment for CLI given its effectiveness, lower cost, and lower risk     of complications. However, 40% of patients will have re-narrowing of the arteries     (restenosis) following the PTA procedure. This is thought to happen in part due to build up     of blood cells called platelets which can also lead to the formation of blood clots. In order     to try to avoid this problem, most patients are prescribed a combination of two blood     thinning medications, acetylsalicylic acid (ASA or aspirin) and clopidogrel (the brand name     is Plavix).      The purpose of this study is to determine if a new blood thinner called rivaroxaban, given in     combination with aspirin, would be more effective in preventing re-narrowing of the arteries     than the current standard of care (aspirin and clopidogrel).      Rivaroxaban is a pill and does not require blood test monitoring. It has been approved by     Health Canada for use in prevention of blood clots in patients undergoing hip or knee surgery     and to treat patients with blood clots in their legs and lungs. Low dose aspirin has been     approved for reducing the risk of heart attacks and strokes. These medications have not been     tested together in patients for prevention of re-narrowing of their arteries      This is a pilot study conducted at one center, The Ottawa Hospital.      It is a Phase 2 open label randomized controlled trial.      Following the PTA procedure, once all inclusion/exclusion criteria are met, the participant     will be randomized into one of two groups:        1. Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily OR        2. Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily      Visits will occur at 7 days, 30 days, 90 days, 6 months and 12 months. Participants will be     followed for 12 months (± 14 days) in total. All adverse events will be collected for the     duration of the study.   "
78330|NCT02260609|"     A multicenter, open-label, single-arm study to evaluate the safety and efficacy of     GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or     bone.   "
78331|NCT02260596|"     A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant     (HSCT) recipients will be assembled to determine the incidence of respiratory viral     infections diagnosed during an inpatient admission in the first year post-transplant. A     sub-cohort of patients that develop a respiratory viral infection within one year of     transplantation will be leveraged to investigate factors associated with mortality in the     three months after respiratory viral infection.   "
78338|NCT02260505|"     This is a 2 arms study concerning patients with primary GIST who followed an Imatinib     adjuvant treatment for 3 years after surgery and who have a high risk of recurrence.      In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to     determine if the continuation of this treatment is efficient for disease control, in terms of     Disease Free Survival improvement.      In the second arm, patients will discontinue the Imatinib treatment, as standard practice.     This arm will allow to determine if the re-introduction of Imatinib at relapse is still an     efficient treatment for the control of disease.   "
78339|NCT02260492|"     This is a study to establish the equivalence of OT329 Solis and Advair Diskus when     administered by inhalation in patients with asthma.   "
78340|NCT02260479|"     The primary aim was to investigate if preheated skin disinfection with Chlorhexidine in     alcohol was non-inferior compared to room-temperature regarding skin colonization as well as     bacterial colonization in wound, skin temperature and patients experiences.   "
78341|NCT02260466|"     Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS)     markedly increases with age. Aortic stenosis increases left ventricular pressure overload.     Cardiac deposits have been observed in AS and the amount of these deposits has been     correlated to post-surgical outcome. As they are strong echocardiographic and cardiac MRI     imaging similarities between CA and AS, the investigators hypothesized that the deposit     observed in AS is transthyretin amyloid deposit. The investigators objective is to     demonstrate that amyloid deposit is associated with poor outcomes following aortic stenosis     surgical valve replacement.      Materiel and methods: 180 patients with indication for surgical aortic valve replacement will     be recruited prospectively and consecutively in 5 French centers. A replicative study will be     performed in one Austrian center. Echocardiography, cardiac MRI and bone scintigraphy will be     performed prior to surgery. During surgery, a basal LV septum biopsy will be collected for     determination and quantification of interstitial deposits using specific staining which will     be performed in a blind fashion. Clinical outcomes will be recorded during the     hospitalization period following the surgery and at 1 year. Alive and re-hospitalization     status will be determined. Patients will be classified according to the presence or not of     amyloid deposits.      Expected results and impact: This study will emphasize how pressure overload stress     accelerates and magnifies amyloid deposition usually known to be related to cardiac aging     process. It will develop reliable imaging tools and markers to detect cardiac amyloid     deposition. Correlation between anatomopathologic analyses and the three different imaging     technics will identify accurate imaging markers of CA. A risk stratification model based on     amyloid deposits level for the clinical management of these patients will be created     combining imaging and biological markers.   "
78342|NCT02260453|"     The purpose of this study is to evaluate the potential benefit of systematic preoperative     coronary angiography followed by selective coronary artery revascularization on the incidence     of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD)     and undergoing carotid endarterectomy (CEA).   "
78343|NCT02260440|"     This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity, safety,     and tolerability of Pembrolizumab in combination with azacitidine in subjects with     chemo-refractory mCRC without any further standard treatment options      Dosage and regimen for all study periods        -  Pembrolizumab will be given at 200 mg every 21 days.        -  Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21          days.      The first assessment of tumor response will be performed after cycle 3 (9 weeks), and     thereafter approximately every 9 weeks, every 3 cycles of therapy. The modified RECIST 1.1     will be used to establish disease response or progression.      All patients will be evaluated and graded for adverse events according to the NCI Common     Terminology for Adverse Events, version 4.0 (NCI-CTCAE).   "
78344|NCT02260427|"     Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these     devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating     laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new     single-use device that may optimise the airway sealing while reducing the potential for     postoperative complications such as sore throat. The overall structure of the air-Q sp is     similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial     was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients   "
78383|NCT02259920|"     Study to determine and compare the absorption of KUC 7483 CL from different regions of the GI     tract with the immediate release formulation and to compare the absorption of particulate     versus solution formulations from the ascending colon   "
78384|NCT02259907|"     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483   "
78385|NCT02259894|"     To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in     single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in     healthy subjects   "
78345|NCT02260414|"     In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients     with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or     erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in     myeloma seems no more effective than that achieved with aspirin, while the effectiveness of     the latter in the primary prevention of VTE has never been demonstrated regardless of the     type of population considered. Meanwhile, a biological study showed that prophylactic doses     of LMWH in patients with different types of cancer did not always optimal reduction of     thrombin peak during the 24 hours following the injection of LMWH. These clinical and     biological studies lead to the conclusion that patients with myeloma may be resistant to the     usual doses of preventive LMWH, which may explain the failure of prevention.      Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is     present in patient's biology and if this resistance is specific to myeloma in hematological     cancers. For this, we propose to study the evolution of thrombin generation by     Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin in     6 patients with de novo myeloma whit high thrombo embolic risk ie treated with thalidomide,     lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not accumulate in     patients with impaired renal function, and has a greater anti-biological activity thrombotic     than other LMWH.      To assess whether the observed pattern of thrombin generation is particularly multiple     myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical     patients hospitalized for acute heart and respiratory failure.   "
78346|NCT02260401|"     Spinal stenosis is one of the most common causes of low back pain among older adults and can     result in significant disability. Despite this, it still isn't known which treatments are     most effective or what outcomes are most important to these older adults. Through a Patient     Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the     existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness     research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS     trial) to address several critical research questions. The proposed study will answer the     following key questions. Do decision aids tailored to older adults with spinal stenosis     change patient decision-making regarding subsequent treatments? Do patients respond     differently at subsequent outcome assessments time-points after receiving tailored decision     aids that contain their own individual outcome data from prior treatments? The investigators     hypothesize that providing these individualized reports will allow patients to make more     informed choices regarding subsequent treatments, leading to reduced use of ineffective     treatments and improved outcomes overall.   "
78348|NCT02260375|"     The general aim of the present study is to test a cell therapy with third-party allogeneic     ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs     will be prepared accordingly to established protocols , starting from diagnostic samples of     bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the     bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities     and used for the present study in patients undergoing liver transplantation.   "
78349|NCT02260362|"     The complex congenital cardiac malformations are a significant number of different diseases,     each having specific natural histories. The interface with pulmonary arterial hypertension     (HTAP) is high since the physiology of many of these disorders comprises alterations in     pulmonary vasculature.      This observatory is a cohort of 400 patients enrolled in 3 years, older than one month,     having been informed and have agreed to participate in the study and with congenital heart     disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension     confirmed by cardiac catheterization.      The main objectives of this report are to know        -  Incidence of congenital heart disease in HTAP France.        -  Describe the natural history of HTAP in a large population of patients Congenital heart          disease in France        -  The characteristics of HTAP congenital heart disease        -  Having a cohort study   "
78350|NCT02260349|"     Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a major     public health problem. Until 28% of patients treated with surgery will present a positive     surgical margin resulting in an incomplete clearance of the tumoral process and exposing so     the patient at a local, systemic recurrence and increased morbidity. An increasing number of     international publications have shown (ICG) was interesting for the detection of the sentinel     lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from     colorectal diseases, but also in the surgery of the kidney, bladder or breast. ICG has     affinity for tumor and tissues around the tumor related to micro-vascular histology for a     localized and specific deposit (EPR effect).      The detection of ICG 's deposits is now possible with to the use of a device which allow to     visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm.     Thanks to this feature, the location of residual tumor tissue when performing a radical     prostatectomy could be made much easier.   "
78351|NCT02260336|"     The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic     Pain.   "
78352|NCT02260323|"     To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic     rheumatic disease   "
78353|NCT02260310|"     The purpose of this study is to evaluate the effect of acupuncture protocol involving in     Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.   "
78354|NCT02260297|"     70 overweight or obese adults with sleep disorders will be recruited for this study, in which     the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep     monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters     derived from this actigraphy.   "
78355|NCT02260284|"     The purpose of this study is to evaluate the efficiency and safety of Acupotome in Treating     Ankylosing Spondylitis.   "
78356|NCT02260271|"     Create a database with selected medical information on infants born with hypoxic-ischemic     encephalopathy (HIE). In addition, the following samples will be collected in a     bio-repository for future studies: blood, urine, and buccal samples.   "
78357|NCT02260258|"     The main purpose of this study is to evaluate if neuromuscular blockade improves lactate     clearance (and preliminary secondary clinical outcome measures) as compared to usual care in     post-cardiac arrest patients undergoing targeted temperature management.   "
78358|NCT02260245|"     TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) is an     evidence-based teamwork system designed to improve communication and teamwork skills among     health professionals. The program was developed by the Agency for Healthcare Research and     Quality (AHRQ) and the Department of Defense's Patient Safety Program as the national     standard for team training in health care.      The purpose of this study is to evaluate the effect of the TeamSTEPPS program on the team     knowledge, skills and attitudes and patient safety at Planned Parenthood affiliates     nationwide.      The investigators hypothesize that implementation of the TeamSTEPPS program will be     associated with improved team knowledge, skills, and attitudes; clinical outcomes; and     process outcomes.      Aims:        1. To assess the effect of the TeamSTEPPS training program on team communication and          effective team work        2. To assess the effect of the TeamSTEPPS training program on process outcomes        3. To assess the effect of the TeamSTEPPS training program on clinical outcomes   "
78359|NCT02260232|"     Objective: To investigate the effects of a one-year worksite individual exercise intervention     on lifestyle-related modifiable health risks, physical capacity and work performance.      Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104     men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical     activity levels were assessed by the long self-administrated version of the International     Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal     cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were     collected from participants at baseline survey, at 6 months and 1-year after. Components of     the program included supervised moderate to high intensity cardiorespiratory exercise,     resistance training, and flexibility.   "
78360|NCT02260219|"     Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage     Device, model M4 compared with the model S2.      Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group     (M4 and S2). They will be operated using conventional techniques and creating a     sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be     monitoring for one year and the results will be evaluated with respect to a postoperative     reduction in pressure, changes in visual acuity, the need for drugs and complications, in     addition to the demographic characteristics of each group.   "
78361|NCT02260206|"     The effects colchicine administration for acute pericardial effusion after radiofrequency     catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.   "
78362|NCT02260193|"     The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and     tolerability of orally administered AKB-6548 in subjects with end stage renal disease     undergoing chronic hemodialysis.   "
78367|NCT02260128|"     Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel     function. This study evaluates whether chewing gum can reduce the bowel paralysis after     surgery in patients undergoing either esophageal resection or whipples procedure. Half the     study population will receive chewing gum while the other half will act as control.   "
78368|NCT02260115|"     The purpose of this study is to obtain data on the safety and manageability of applying LABS™     to the uterus and other areas of surgical trauma in the pelvis and abdomen following     laparoscopic gynaecologic surgery. In addition, performance data following a clinical     indicated second look laparoscopy will be collected for the purpose of determining sample     size predictions for future trials.   "
78369|NCT02260102|"     Temocillin (6-methoxy-ticarcillin) is a beta-lactam antibiotic with exceptional resistance to     most beta-lactamases. In this context, it is now increasingly used as carbapenem-sparing     antibiotic in patients with suspected infection by Enterobactreriaceae suspected to produce     extended-spectrum beta-lactamases. Little is known about dosing and elimination of temocillin     in children. While available literature of temocillin use in paediatrics refers mainly to its     clinical efficacy in the treatment of urinary tract infections, the drug is also used for the     treatment of suspicion of cholangitis in cirrhotic paediatric patients, and as antibiotic     prophylaxis following an hepatic transplant in children (both off-label indications). There     is, therefore, a pressing need to explore the pharmacokinetics and pharmacodynamics of     temocillin in the paediatric population, in order to provide clear guidance on an appropriate     dosing regimen. The study objectives are: (1) characterisation of the pharmacokinetics (PK)     of temocillin in 3 paediatric populations, (2) proposal and development of a dosing schedule     that can ensure therapeutic concentrations (40% ƒT > MIC) and optimize treatment chances of     success, and (3) characterization of MICs of microbiological strains (when available) to     temocillin.   "
78370|NCT02260089|"     To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with     mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with     ABPM   "
78371|NCT02260076|"     To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses   "
78372|NCT02260063|"     To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup     and 20 mg tablets   "
78373|NCT02260050|"     To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the     conventional formulation of WAL 801 CL dry syrup   "
78374|NCT02260037|"     Safety, tolerability and pharmacokinetics   "
78375|NCT02260024|"     The primary objective of the study was to estimate the magnitude of the error in the     prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data     applying the methods of IVIVC. The secondary objective of the study was to investigate     whether the intake of food 30 minutes prior to drug administration affects the systemic     exposure of pramipexole SR C2 or not   "
78376|NCT02260011|"     The objective of this study was to compare the bronchodilator efficacy and safety of     ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation     Aerosol in COPD patients   "
78377|NCT02259998|"     To investigate the relative bioavailability of the proposed formulation of PERSANTIN®     compared to the present commercial formulation.   "
78378|NCT02259985|"     food interaction, pharmacokinetics, safety and tolerability   "
78379|NCT02259972|"     To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of     BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs.     fed (food effect for the tablet).   "
78387|NCT02259868|"     1. To investigate the relative bioavailability (BA) of improved tablet formulation          candidates to determine which formulation will be developed for use in late Phase II and          Phase III clinical trials        2. To investigate the relative BA of the pediatric suspension, compared to the current 1B          formulation        3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three          25mg tablets vs. one 75 mg tablet, current 1B formulation   "
78388|NCT02259855|"     The primary objectives were:        -  To determine the effects of steady state TPV co-administered with low dose RTV on steady          state PegIFN and RBV in HIV negative subjects with mild hepatic impairment (scheme A)        -  To determine the effects of steady state of pegylated interferon (PegIFN) and RBV on          steady state pharmacokinetics of TPV co-administered with low dose RTV in HIV negative          subjects with mild hepatic impairment (scheme A)        -  To determine the pharmacokinetics of single dose and steady state TPV/r 500/200 mg in          subjects with moderate hepatic insufficiency (scheme B)   "
78398|NCT02259725|"     This phase II trial studies regorafenib in treating patients with neuroendocrine tumors that     have spread from the primary site (place where it started) to other places in the body.     Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
78399|NCT02259712|"     Introduction: Hipopressive Exercises are included within a method of physiotherapy which was     created with the purpose of strengthening the deep muscles of the abdomen without damaging     ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic     floor reflexively. Although this technique has been included as treatment and a prevention     method of pelvic floor dysfunction, there are few studies supporting its benefits. The     investigators hypotthesis is that the combination of both physical therapy treatments will     provided the best results for women who suffer pelvic floor dysfunctions.      Objective: To determine whether Hipopressive Exercises are an option to include in the     physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the     results reported are comparable to those provided by the classical perineal physiotherapy.      Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the     intervention group to which subjects were assigned. Participants will be randomly assigned to     three groups:        1. An experimental group, where the participants will be treated by Hipopressive exercises          and hygienic and behavioral measures;        2. Another experimental group where classical perineal physiotherapy will join with          Hipopressive exercises and hygienic and behavioral advises;        3. And a third group where will be done classical perineal physiotherapy and hygienic and          behavioral measures.      Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made.     The selection criteria will be: adult women who present signs and symptoms that indicate a     pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must     understand and sign freely Informed Consent.      Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast,     26 subjects were required in each group to detect a difference equal to or greater than 3     microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the     rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).      Data Analysis: A descriptive analysis of all variables was performed. It establish for all     cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the     experienced change of the three goups in outcome variables between physicaltherapy     examinations.   "
78400|NCT02259699|"     The objective of this study is to develop and test a new decision aid -named Patient Centered     Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs     about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on     their own preferences and personal clinical characteristics, described in terms that are     meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient-     and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized     controlled trial (RCT).      The investigators hypothesize that PCOA will be significantly better than usual care,     resulting in patients reporting more satisfaction with their treatment decision, less     decision regret, better quality of life, and more satisfaction with their care compared with     similar patients not having access to PCOA. If these hypotheses are substantiated, patients     and providers will have an improved model for communication and decision making, leading to     better patient outcomes.   "
78401|NCT02259686|"     Apelin is an endogenous peptide with physiological actions in the cardiovascular system.     Apelin can modulate vasomotor tone and is a potent endogenous inotrope. In a series of     clinical studies, we have shown that apelin causes peripheral and coronary vasodilatation and     increased cardiac contractility. We wish to study and compare the cardiovascular effects of     subcutaneous versus intravenous apelin. We specifically wish to determine how different     methods of apelin administration affect cardiac output and peripheral vascular resistance in     healthy volunteers   "
78402|NCT02259673|"     In this research, the elderly living in nursing homes were selected in two group control and     intervention.      Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises     (including activities carried out with the use of sports equipment such as beach ball,     stretch, bird toys, etc).   "
78403|NCT02259660|"     The purpose of this research study is to determine if muscle training will improve snoring     and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of     their apnea. After this study, subjects will be randomly assigned to one of two groups. The     first group will receiving a breathing trainer that may strengthen the muscles used to breath     in and out. The second group will be receive a sham trainer which looks like the real     trainer but is not able to produce a strengthening effect. Both groups will complete eight     weeks of home based (real or sham) training. The sleep study will be repeated and we well     measure any changes in measures of severity for obstructive sleep apnea.   "
78404|NCT02259647|"     60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient     will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and     control group will receive Sorafenib plus placebo   "
78405|NCT02259634|"     This is a 3-year prospective randomized comparative study of the efficacy of patient     navigation on health education, health related quality of life, healthcare utilization, and     medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the     patient-navigator intervention or to a care-as-usual control condition. A total of 300     recently incarcerated individuals will be enrolled with 150 subjects each in the intervention     and usual care group.      The investigators hypothesize that the intervention will improve health education, health     related quality of life, adherence to clinical appointments, glycemic/blood pressure control,     and virologic suppression in HIV-infected. The results of this study will demonstrate     interventions to eliminate health disparities in a highly marginalized group going through     the transitional phase of re-entry into the community.   "
78453|NCT02259010|"     This study will assess the effect of multi-dose administration of itraconazole on the     single-dose pharmacokinetics (PK) of alisertib.   "
80543|NCT02231671|"     The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from     the body.   "
78406|NCT02259621|"     The proposed study will evaluate the safety and feasibility of preoperative administration     nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a     comprehensive exploratory characterization of the tumor immune milieu and circulating immune     cells and soluble factors in these patients. Data obtained in this study will provide     valuable information for planning further prospective clinical trials of anti-PD-1 and other     immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.   "
78437|NCT02259218|"     This research trial studies metabolomic and other molecular profiling to identify predictive     biomarkers for radiation toxicity and survival in patients with lung or brain cancers     receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with     lung or brain cancer in the laboratory may help doctors identify and learn more about     biomarkers related to cancer and predict which patients are at higher risk for developing     radiation side effects and how well patients will respond to radiation treatment.   "
78438|NCT02259205|"     This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted     from olive mill waste in platelet aggregation and other inflammatory and oxidative stress     markers. The study will include three groups: the intervention group will receive the     enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt     consumption).   "
78407|NCT02259608|"     Rationale: The live attenuated Bacillus Calmette-Guerin (BCG) vaccine protects against     extrapulmonary infection with Mycobacterium tuberculosis and leprosy. It has been shown that     vaccination with BCG also leads to nonspecific protective effects, e.g. reduced infant     mortality as a result of less severe infections, stimulation of the immune system in patients     with bladder cancer and higher cytokine production upon restimulation of macrophages with     non-related infectious pathogens in vitro. However, because the live attenuated BCG vaccine     cannot be used in immune compromised hosts, the investigators would like to determine whether     similar protective non-specific effects can be induced by γ-irradiated BCG.      Objective: To determine whether vaccination with γ-irradiated BCG results in a higher     cytokine response by monocytes upon restimulation in vitro with infectious pathogens,     compared to monocytes before the vaccination.      Study design: Explorative intervention trial. Study population: Healthy volunteers, 18 - 55     years old. Intervention: Healthy volunteers will be vaccinated with γ-irradiated BCG vaccine.      Main study parameters/endpoints: Blood will be drawn before and at two different time points     after vaccination with BCG to perform restimulation of isolated cells in vitro and compare     cytokine production.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: There is no known direct benefit for the volunteers to participate in the trial.     The risks are negligible. BCG vaccination can cause pain and scarring at the site of     injection, just as fever and headache. Local hematoma formation can occur at the site of the     blood drawing. This will be minimized by the blood collection by experienced persons.   "
78408|NCT02259595|"     This study is a single-center, randomized, placebo-controlled, double-blind, single ascending     dose escalation study to determine the safety, tolerability, and PK profile of oral     administration of HPN-07 in single doses to approximately 32 healthy male and female subjects     between 18 and 55 years of age.      Subjects will receive single oral doses of the study drug. The primary endpoint of this trial     is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC).   "
78409|NCT02259582|"     A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV     non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given     in combination with carboplatin and pemetrexed compared to placebo. The administration of     carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small     cell lung cancer.   "
78410|NCT02259569|"     The purpose of this study is to compare peak airway pressure and gastric insufflation in     Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric     patient   "
78411|NCT02259556|"     Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of     tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be     treated by CD30-specific CART cells (CART30).   "
78412|NCT02259543|"     The aim of this study is to investigate the effects of the application of a citric acid +     tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the     outcomes of treatment of Miller's class I or II recession defects by subepithelial connective     tissue graft.   "
78413|NCT02259530|"     The research project will offer psychotherapeutic treatment to Somali refugees with PTSD and     comorbid khat dependence. In this case series, evidence-based techniques will be applied and     adapted to the cultural background of Somali refugees in Kenya.   "
78414|NCT02259517|"     Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two     types of medications with differing mechanisms of action: stimulants and non-stimulants. The     stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release     guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that     both medications are effective in reducing ADHD symptoms, although the neurobiological     mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of this     study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients with     ADHD. MRI scanning will be used to identify treatment-related changes in brain structure and     function.   "
78459|NCT02258932|"     Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for     diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin infusion     (CSII) is an effective method of achieving this. Among the advantages of CSII is the     opportunity for patients to potentially discard relatively inflexible mealtimes and     carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).     There are also reported improvements in quality of life. Furthermore, in patients with good     glycaemic control, such as those often assisted by CSII, various qualitative atherogenic     lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;     potentially leading to increased cardiometabolic risks. Literature examining the eating     behaviours, quality of life and cardiometabolic risks of CSII patients over time after     commencement of the therapy is sparse, frequently dated and worthy of further research.   "
78415|NCT02259504|"     This is a prospective, single-arm, multi-center post-marketing Study. The Study will commence     as a single phase, with an optional second phase to follow at the discretion of the sponsor.     Up to 300 eligible Subjects with small (< 4.9 mm) intracranial aneurysms, who consent to     Study participation, will be treated in Phase 1 with Microvention HyperSoft® 3D and     HyperSoft® helical coils with or without balloon remodeling or stent assistance at the     discretion of the treating physician. The operator, at his/her discretion, may choose to     frame the aneurysm with HyperSoft® 3D or any other bare metal coil but must finish the     remainder of the aneurysm with HyperSoft® 3D and/or HyperSoft® helical coils. Upon approval     and availability of HydroSoft® 3D, and at the discretion of the sponsor, additional patients,     up to 300 patients total for the overall Study, with eligible aneurysms will be enrolled into     Phase 2. In Phase 2 the aneurysm must be framed with HydroSoft® 3D and finished with     HyperSoft® 3D and/or HyperSoft® helical coils. Data will be collected on immediate and     post-treatment angiographic occlusion rates (RRGS), new peri-procedural imaging-confirmed     hemorrhage or ischemic stroke, neurological morbidity and mortality rates, recurrence rates,     bleeding rates, retreatment rates, serious adverse events, >150 day angiographic occlusion     rates (RRGS) and occlusion status. This will serve to establish the acute and sustained     efficacy of EVT of small intracranial aneurysms with the specified microcoils, aided by     balloon and/or stent remodeling where appropriate.   "
78425|NCT02259374|"     TAP block performed under ultrasound guidance is used as part of multimodal analgesia to     relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used     include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission     of pain from the site of tissue injury. An important component of the pain experienced by     patients after abdominal surgery derives from the abdominal wall incision. The abdominal wall     sensory afferents course through the transversus abdominis (neurofascial) plane superficial     to the transversus abdominis muscle. Single shot TAP block has been shown to provide pain     relief of up to 24h in surgeries involving pfannenstiel incisions, hence a study period of     24h is chosen in patients undergoing hysterectomy.      This study was designed to test the hypothesis that the TAP block, as part of a multimodal     analgesic regimen, even at a lower concentration, would provide effective analgesia in the     first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.   "
78416|NCT02259491|"     Since antiquity, honey has been recognized for its healing properties. Literature about the     use of medicinal honey for wound care dates back centuries with recent data suggesting its     use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey     (Leptospermum scoparium) to have significant immune benefits and the ability to influence all     phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous     clinical studies have identified positive benefits for wound healing. However, there is a     lack of prospective, randomized controlled data on the use of honey as a medicinal agent in     local wound care and scar healing.      In order to better understand Manuka Honey's ability to aid in healing, the investigators are     conducting a randomized, controlled, single-blinded study of patients undergoing     reconstructive surgery. This project uses split thickness skin graft and free tissue transfer     donor sites as standard wound models to compare the effects of Manuka Honey versus standard     wound care therapies. Through the use of standard wound model and objective measurement     tools, the investigators hope to better elucidate any benefits of this novel wound care     'technology.'   "
78417|NCT02259478|"     Patients at high risk of IVIG-associated hemolysis (defined as receipt of a 28-day cumulative     dose of ≥ 2 g/kg, adjusted for ideal body weight, and non-O blood group) will be     prospectively monitored using a standardized protocol for signs of hemolysis, and will be     undergo additional testing for variables that have been hypothesized to increase the risk of     hemolysis. The goal of the study is to define the incidence and dynamics of IVIG-mediated     hemolysis and identify patient and product-related factors that may predict which patients     are especially at risk.   "
78418|NCT02259465|"     Some carbohydrates, complex sugars, which are found in grains, fruit and vegetables, cannot     be digested by humans. When eaten they pass through the small bowel to the large bowel, or     colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use     them as an energy source. This releases energy that humans can absorb, and may have other     effects on health as well. The process also releases gases such as hydrogen and methane into     the colon, which will eventually be released as flatulence.      There is some evidence in animals, and humans, that changing the carbohydrate content of the     diet may increase the numbers of bacteria in the colon that can use this energy source.     Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect     transit, the speed at which food and stool moves through the stomach and bowels.      This undergraduate project will use techniques in Magnetic Resonance Imaging developed in     Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed     of transit through the bowel and gas production in the colon, and whether there is any immune     reaction to the carbohydrate from the bowel wall.   "
78419|NCT02259452|"     The purpose of the study is to assess the time, dose dependence, and fraction-size dependence     of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure     following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI     hopes to develop models to better relate and predict RT-induced changes in regional lung and     heart perfusion/function/structure with changes in global cardiopulmonary function. Patients     will undergo pre- and serial post-RT lung and heart assessments to better understand     RT-induced regional heart/lung changes.   "
78420|NCT02259439|"     Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading     cause of morbidity and mortality.Patients admitted to hospital present higher mortality     rates.The investigators lack the specific tools that allow us to easily classify and     establish the individual prognosis for each patient during their hospitalization.      Rational of the study:to identify the predictive factors for hospital mortality in critically     ill patients admitted to hospital due to an episode of COPD exacerbation.   "
78548|NCT02257749|"     The purpose of this randomized control trial study is to determine if an active     rehabilitation (low intensity exercise program) in combination with a comprehensive education     intervention (standard care) is more effective than the comprehensive education intervention     alone in reducing post-concussion symptoms and improving participation in daily activities in     youth who have persistent post-concussion symptoms.   "
78421|NCT02259426|"     Primaquine (PQ) is currently the only available drug that can clear the mature transmission     stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist     after artemisinin-combination therapy. A major caveat to the use of primaquine in mass     adminsitrations for the reduction of malaria transmission is that metabolism of the drug in     individuals with glucose-6 phosphate dehydrogenase (G6PD) deficiency can lead to transient     haemolysis. The haemolytic side effect of PQ is dose-related. Haemolysis is more commonly     observed after prolonged PQ treatment but has also been observed in African populations     following a single dose of PQ. This haemolysis was self-limiting, largely restricted to G6PD     deficient individuals and did not lead to clinical symptoms. Nevertheless, any drug-induced     haemolysis is reason for concern and the World Health Organization has therefore reduced the     recommended dose of single low dose primaquine from 0.75mg/kg to 0.25mg/kg. This dosage is     deemed safe without prior G6PD or Hb screening. However, there is limited direct evidence on     the extent to which this dosage of PQ prevents malaria transmission to mosquitoes.      In the current study, the investigators will assess the efficacy of DP in combination with     low-dose PQ to prevent onward malaria transmission. The investigators will perform the     investigators study in individuals aged 5-15 years who are carry microscopically detectable     densities of P. falciparum gametocytes. This age group is chosen because asexual parasite     carriage and gametocyte carriage are common in this age group. All enrolled individuals will     receive a full three-day course of DP, and will be randomized to receive a dose of primaquine     or placebo with their third dose. Efficacy will be determined based on gametocyte carriage     during follow-up, measured by molecular methods. For all individuals, the effect of treatment     on infectivity to mosquitoes will be assessed by membrane feeding assays at two time points.   "
78422|NCT02259413|"     The purpose of this study is to determine whether participation in a 12 week exercise     rehabilitation program is effective at reducing symptom burden and improving quality of life     in individuals receiving chronic hemodialysis.   "
78423|NCT02259400|"     The purpose of this study is to determine whether two different strategies of Non Invasive     Ventilation (NIV) have different effect on length and failure of NIV support in preterm     infants with respiratory distress syndrome (RDS).   "
78424|NCT02259387|"     The overall objective of this proposal is to better define the relationship between perceived     stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of     the study: those with migraines (cases) and those without migraines or headaches (controls).     Each arm will answer several of the same questionnaires and have hair cortisol samples taken     multiple times over the course of 12 weeks.   "
78426|NCT02259361|"     This study evaluates the effects of sustained-release oral dalfampridine in the treatment of     upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized     pilot study half of participants will dalfampridine, while the other half will receive a     placebo.   "
78571|NCT02257437|"     The purpose of this trial is to evaluate the acceptability of the LNS to women and their     children aged 12-17 months in comparison to Corn Soy Blend++, and Sprinkles added to borbor     (white rice porridge, which is the traditional weaning food in Cambodia). Acceptability will     be assessed through a sensory test for caregivers, and by measuring children's consumption.   "
78427|NCT02259348|"     This pilot phase II trial studies how well a new reduced intensity conditioning regimen that     includes haploidentical donor NK cells followed by the infusion of selectively T-cell     depleted progenitor cell grafts work in treating younger patients with hematologic     malignancies that have returned after or did not respond to treatment with a prior     transplant. Giving chemotherapy and natural killer cells before a donor progenitor cell     transplant may help stop the growth of cells in the bone marrow, including normal     blood-forming cells (progenitor cells) and cancer cells. It may also stop the patient's     immune system from rejecting the donor's cells. When the healthy progenitor cells from a     related donor are infused into the patient they make red blood cells, white blood cells, and     platelets. Sometimes the transplanted cells from a donor can make an immune response against     the body's normal cells (called graft-versus-host disease). Removing specific T cells from     the donor cells before the transplant may prevent this.   "
78428|NCT02259335|"     Weaning from invasive mechanical ventilation is one of the major clinical problem especially     ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.      The aim of this pilot feasibility and safety trial is to assess the possibility of shorten     the duration of mechanical ventilation using a device able to remove CO2 and theoretically     able to allow therefore the praecox extubation   "
78429|NCT02259322|"     This study will test the effectiveness of two distinct behavioral treatments for loss of     control eating following bariatric surgery:        1. Behavioral Weight Loss Treatment        2. Cognitive Behavioral Therapy      These treatments will be compared to Standard-of-Care.   "
78430|NCT02259309|"     The present study is designed to address the null hypothesis that there is no difference in     the local and systemic immunomodulatory effects of buccally or vaginally administered     misoprostol in healthy, reproductive-age women.   "
78431|NCT02259296|"     The timing for arteriovenous fistula (AVF) creation and its effect on target organs in     patients with chronic renal failure will be investigated by multicenter prospective cohort.     Lower estimated glomerular filtration rate (eGFR) patients (eGFR<10ml/min 1.73m2 for patients     without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) and     higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease,     and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF     creation. Maturation rate and time of AVF will be followed up in 3 months; primary and     secondary patency rate of AVF, AVF construction on cardiac structure, function,     encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the     next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF     creation   "
78432|NCT02259283|"     Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently     the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo     myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is     performed, and has advantage over surgery because it is performed endoscopically, thus is     less invasive. One potential disadvantage in respect to surgery may be that it may determine     higher rates of post-operative reflux. The purpose of this study is to prospectively assess     the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3     and 12 months.      This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of     achalasia, without megaesophagus or colonic esophagus, will be included for the POEM     procedure.      This study will last about 2 years. The aim is the feasibility, security and success rate of     POEM for achalasia. Patients will be followed for at least one year.   "
78433|NCT02259270|"     Acid suppressive therapy (AST) is used in a variety of indications in prevention and     treatment of gastric acid related disorders. In recent years, an increase in the use of acid     suppressive therapy has been documented. It has generally been accepted that these agents are     effective and safe. However, very recently, reports describing hypomagnesaemia, hypocalcemia,     vitamin B12 deficiency and enteric infections, were published.      The goal of this study is to evaluate 1) how many cases of long-term ambulatory treatment     with AST are initiated during hospital stay (= ASTRA-1), and 2) assess the appropriateness of     initiation of AST and the appropriateness of continuation of AST at discharge in a subset of     the hospitalized patient population (= ASTRA-2). Finally, the pharmacoeconomic impact of     inappropriate AST during hospitalisation will be calculated from these data.      The primary endpoint is defined as the number of patients on long-term ambulatory AST after     initiation in the hospital. Secondary endpoints are the appropriateness check of AST both at     the level of initiation during hospitalization and at discharge (appropriate continuation);     also the impact on the hospital budget (lump sum budget) will be calculated, and potential     cost avoidance for long-term ambulatory inappropriate AST will be estimated from a healthcare     payer perspective for a period of 1, 3, 6 and 12 months.   "
78434|NCT02259257|"     Contrast enhanced 3D/4D (3 dimension/4 dimension) ultrasound (CEUS) provides visualization of     the dynamic vascular features of the plaques, in a unique spatial format using three     orthogonal planes and angiogram-like images. Therefore, the observer can utilize the entire     vascular system in a volumetric manner (3D). The rotation of the intra-plaque neovasculature     as viewed in various angles provides a realistic representation that is more easily     appreciated. Inter-observer variability for individual plaques has been assessed and     inter-observer variability and inter-scan variability (the analysis of multiple images from     single patients in longitudinal studies) were dependent on plaque size, with larger plaques     showing lower variability. Therefore, the proposed 3D/4D vs. 2D CEUS imaging of the carotid     plaque will provide added value for the depiction of the and quantification of intra-plaque     blood vessel density by providing a true volumetric viewing area. This data will be     correlated to the subsequent surgical specimens. The goal of the protocol is to investigate     the correlation of intra-plaque blood vessel density and hemorrhage to 3D/4D CEUS vasa     vasorum using quantitative software analyses. The histology methods used for quantification     of hemorrhage and vessel density analyses.   "
78435|NCT02259244|"     The purpose of this study is to evaluate the combined effect of physical activity and     adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative     stress in obese patients enrolled in the weight management reduction program.   "
78436|NCT02259231|"     Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for     approximately three-fourths of all skin cancer deaths. For metastatic or unresectable     melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab     and nivolumab) and other therapies, however, approved therapies are rarely curative.      It is now well accepted that tumors are able to evade detection and eradication by the immune     system, even though many tumor types, particularly melanoma, are capable of eliciting a     strong immune response (Swann, 2007). Substantial mechanistic work in recent years has     revealed the key role of myeloid-derived suppressor cells (MDSCs) in masking cancer cells     from the immune system, promoting both tumor progression and resistance to cancer     immunotherapy. The immune-suppressive effect of MDSCs is dependent on the production of     reactive oxygen species (ROS) and reactive nitrogen species (RNS). High levels of these     reactive molecules and their by-products, such as nitrotyrosine, have been correlated with     poor clinical outcomes in melanoma. Currently available melanoma therapies do not target     MDSCs.      In animals, RTA 408 significantly reduces tumor nitrotyrosine burden, inhibits the activity     of MDSCs, and augments T-cell anticancer activity at relevant doses. Thus, through inhibition     of MDSC activity and suppression of tumor ROS/RNS, RTA 408 may work in combination with     T-cell-activating therapeutics such as ipilimumab to enhance the natural immune anticancer     response. RTA 408 also has direct anticancer effects via inhibition of NF-kappa B. Chronic     activation of NF-kappa B is associated with tumor progression, metastasis, and resistance to     therapy.      This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and     pharmacokinetics of omaveloxolone (RTA 408) in combination with ipilimumab or nivolumab in     patients with unresectable or metastatic melanoma.      In this open-label, multicenter, dose-escalation, Phase 1b/2 study, patients who qualify will     receive omaveloxolone (RTA 408) at the assigned dose level in combination with ipilimumab or     nivolumab. Patients will receive omaveloxolone (RTA 408) orally once daily for 1 week prior     to initiation of ipilimumab or nivolumab. For patients treated with ipilimumab , the run-in     period will be followed by omaveloxolone (RTA 408) orally once daily in combination with     ipilimumab administered at Weeks 1, 4, 7, and 10. After Week 10, patients will receive     maintenance treatment with omaveloxolone (RTA 408) alone once daily. For patients treated     with nivolumab, the run-in period will be followed by omaveloxolone (RTA 408) orally once     daily in combination with nivolumab administered approximately every two weeks as clinically     indicated. Each patient will continue at the assigned omaveloxolone (RTA 408) dose level     until disease progression occurs, toxicity requiring discontinuation from study drug (i.e.,     RTA 408) is experienced, the patient has completed approximately 72 weeks of treatment, the     patient is discontinued from the study drug for another reason, or the patient withdraws     consent. Patients will return 4 weeks after omaveloxolone (RTA 408) treatment completion for     a follow-up visit.      The starting omaveloxolone (RTA 408) dose level for the first dose-escalation cohort in this     study has been selected based on available safety and pharmacodynamic data from a Phase 1     study of RTA 408 (NCT02029729). Subsequent cohorts will be enrolled at dose levels based on     available safety and PD data from this study, but they will not be greater than 2-fold above     the prior dose level.      Phase 1b (dose-escalation): In the phase 1b/2 portion of this study, 12 patients will be     enrolled in each dose cohort, with six patients administered omaveloxolone (RTA 408) plus     ipilimumab and the remaining six administered rTA 408 plus nivolumab. Subsequent cohorts will     assess escalating the doses of omaveloxolone (RTA 408) administered in combination with     ipilimumab or nivolumab. Dose escalation decisions will be based on ongoing review of all     available safety information for enrolled patients.      Phase 2: The Phase 2 portion of the study may include separate expansion cohorts consisting     of patients treated with either of the combination therapies. Each expansion cohort will     include an additional 24 patients enrolled at the selected Phase 2 dose level to achieve a     total of 30 patients at that omaveloxolone (RTA 408) dose in combination with ipilimumab or     nivolumab.   "
82908|NCT02200809|"     Purpose of the investigators study is to determine the short and medium term histological     cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment     of localised prostate cancer.   "
78439|NCT02259192|"     The purpose of this investigation is to determine the safety and preliminary efficacy of     implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal     hearing (NH) ear (termed single-sided deaf person, or SSD). The potential subjects will     have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound     from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The     long-term goal of this research program is to determine whether the CI, in combination with     the NH ear, may provide improved localization ability and better speech understanding in     noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A     secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity,     compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off,     after implantation.   "
78440|NCT02259179|"     This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy     adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination     trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the     two drug products will be evaluated separately in the fed and fasted state.   "
78441|NCT02259166|"     The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+)     Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP)     supplementation in children, helps maintaining reduced anemia levels among children after a     blanket provision of MNP, and has an impact on child growth, infant and young child feeding     (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria     prevention, food security and women's empowerment.   "
78442|NCT02259153|"     The objective of the study is to assess the effect of two diets with different fat     composition on cholesterol metabolism. The study was a randomized cross-over trial where     volunteers follow two study periods with different types of meat (lean and fat red meat)     separately by a ten days wash-out period. At the beginning of the study and after the study     periods the following parameters are determined: anthropometric (weight, waist, circumference     and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise     assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL     cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid,     glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol,     campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols     (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by     High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout     along the study in order to demonstrate the effect of different red meat on the hepatic     metabolism of cholesterol.   "
78479|NCT02258672|"     The purpose of the present study is to evaluate the effectiveness of a prehabilitation     program on the recovery of patients undergoing a minimally invasive surgery for degenerative     lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two     groups; intervention or control group. Participants in the intervention group will take part     in a physical training program, three times a week for six weeks before undergoing surgery.     The exercise program will be supervised and will aim at improving core muscles strength and     endurance as well as spine stability. It is hypothesized that the prehabilitation program     will significantly improve disability and pain intensity reported by patients after surgery.     Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but     its results may also impact the management of patients awaiting spine surgery for various     conditions.   "
78443|NCT02259140|"     This randomized controlled trial will compare proximal femoral resection-interposition     arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the     treatment of painful irreducible hip dislocation in patients with cerebral palsy. The primary     outcome is quality of life and care giver burden measured by The Caregiver Priorities and     Child Health Index of Life with Disabilities (CPCHILD) score at one year. Secondary outcomes     will include pain (NCCPC-R, PROMIS pain intensity and PROMIS pain interference), function     (mobility questions), complications and surgical parameters such as OR time and fluoroscopy     time. A cost-effectiveness analysis will follow completion of the randomized controlled trial     (RCT). The authors hypothesize that mean CPCHILD scores (measured at 1 year) will be     significantly higher following the Subtrochanteric Valgus Osteotomy technique compared to     Proximal Femoral Resection-Interposition Arthroplasty technique. Furthermore, the Proximal     Femoral Resection-Interposition Arthroplasty technique will have a shorter length of hospital     stay, shorter fluoroscopy and OR times and the Subtrochanteric Valgus Osteotomy will have     longer sitting tolerance, less pain, smaller burden for caregivers, better health, and higher     quality of life. Additionally the authors hypothesize that Subtrochanteric Valgus Osteotomy     will be more expensive than Proximal Femoral Resection-Interposition Arthroplasty, due to the     cost of the plate, longer operative time, longer length of stay, and blood loss, but     Subtrochanteric Valgus Osteotomy will be preferred by patients due to less pain and better     functional and quality of life outcomes.The results of this study are expected to improve     outcomes for children with cerebral palsy with painful irreducible dislocated hips.   "
78444|NCT02259127|"     A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is     non-inferior to the standard combination of medicines used in terms of efficacy and better in     terms of toxicity.   "
78445|NCT02259114|"     Open-label, phase I, non-randomized, multicentric study of single-agent OTX105/MK-8628     administered according to two distinct regimens to participants with selected advanced     tumors.      The study will be performed in two parts.      Dose Escalation Part:      This step is designed to determine the maximum tolerated dose (MTD) in each of the two     regimens, which will be evaluated in parallel. Participants will receive oral OTX105/MK-8628     according to:      Continuous Dosing Regimen: continuous, once daily for 21 consecutive days (21-day cycles).      OR Days 1-7 Dosing Regimen: once daily on Days 1 to 7, repeated every 3 weeks (21-day cycles;     1 week ON/2 weeks OFF).      Participants will be sequentially assigned to Continuous Dosing Regimen or Days 1-7 Dosing     Regimen according to the next available place and receive OTX105/MK-8628 at escalating doses     levels (DL). Cohorts of 3 participants will be treated, and an additional 3 participants will     be treated at the first indication of dose-limiting toxicity (DLT). MTD assessment will be     based on the tolerability observed during the first 21 days of treatment.      Expansion Part:      The efficacy of OTX105/MK-8628 in each of the five indications (i.e., Bromodomain-Nuclear     Protein in Testis [BRD-NUT] midline carcinoma, triple negative breast cancer [TNBC],     non-small cell lung cancer [NSCLC] harboring a rearrangement Anaplastic Lymphoma Kinase [ALK]     gene/fusion protein or Kirsten Ras [KRAS] mutation, castrate-resistant prostate cancer, and     pancreatic ductal carcinoma) will be assessed in terms of response (Response Evaluation     Criteria in Solid Tumors v1.1 [RECIST v1.1] or Prostate Cancer Clinical Trials Working Group     2 [PCWG2]) using a selected regimen.   "
78446|NCT02259101|"     The proposed study will consist of a randomized controlled trial (RCT) comparing a known     efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.   "
78447|NCT02259088|"     Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular     edema (DME)   "
82934|NCT02200458|"     This study will look at the performance capabilities of software for VeinViewer.   "
78448|NCT02259075|"     Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as     headaches for at least 15 days per month, of which 8 days have typical migraine features. In     many cases, oral drug treatment has little effect.      The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved     in several primary headaches, including migraine, by facilitating release of inflammatory     substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of     acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.      The purpose of the present study is to evaluate a new technique with injection of BTA using     an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The     goal is to relieve the migraine symptoms and develop an alternate treatment for cases where     oral drug treatments fail.      The main objective of the project is to determine the safety of this method of BTA injection     in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives     are to measure changes in headache attack parameters with this novel method.   "
78449|NCT02259062|"     Stroke is the biggest cause of disability in older adults. Early poststroke rehabilitation     focuses primarily on physical disability and activities of daily living. By contrast,     relatively little research attention has been paid to the potential for cognitive     rehabilitation and mood enhancing interventions in the early stages after stroke. Low mood     and cognitive difficulties with attention and memory are common post stroke leading to poorer     recovery, emotional wellbeing and quality of life yet accessible and effective therapies are     lacking.      Engagement in leisure activities may enhance recovery after stroke but participation in     leisure activities is reduced following stroke. Music listening is a low cost and accessible     leisure activity that has been suggested to improve mood and cognition poststroke. The     investigators speculate that music listening may enhance control of attention in a similar     way to mindfulness interventions, that have been demonstrated to be beneficial in the     treatment of mood disorders. The investigators propose that adding a brief mindfulness     intervention to music listening might enhance the effect on control of attention, with     positive effects on cognition and mood poststroke but the feasibility and acceptability of     this intervention needs to be evaluated before attempting a further trial assessing the     effectiveness of this intervention. The investigators aim to recruit 100 patients within two     weeks poststroke.      Participants will be randomly assigned to receive an 8 week music listening alone, music     listening with brief mindfulness or audiobook listening intervention alongside treatment as     usual. Neuropsychological assessment of cognition and mood will be performed at baseline, 3     months, and 6 months poststroke In addition, participants will be interviewed about their     experience of engaging in the interventions.   "
78450|NCT02259049|"     The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood     pressure fluctuations in individuals with Parkinson's disease.   "
78451|NCT02259036|"     The primary goal of this research study is to develop an interactive smartphone app that     could be used to increase the effectiveness of talk therapy such as cognitive behavioral     therapy (CBT) for child anxiety.   "
80544|NCT02231658|"     The present study will compare lixisenatide and liraglutide in a population of subjects with     T2DM not optimally controlled on OADs and / or insulin, which is the target population for     these medications.   "
78454|NCT02258997|"     The investigators propose that patients with HbSβ-thalassemia have lower levels of hepcidin     and higher levels of GDF-15 than HbSS patients during the non-crisis, steady states. In     addition, the investigators propose that when controlled for RBC transfusion, patients with     HbSβ-thalassemia will have higher levels of storage iron (based on serum ferritin).      Participants: Total number of subjects is 42 - 21 subjects with HbSS, and 21 subjects with     HbSβ-thalassemia ).      Procedures (methods): Eligible subjects with documented SCD (HbSS, HbS-β 0-thalassemia or     HbS-β+-thalassemia) followed at the University of North Carolina (UNC) Comprehensive Sickle     Cell Program will be evaluated in this single-center, prospective, cross-sectional study. The     patients will be screened for eligibility at the time of a routine sickle cell clinic visit.     Patients' data will be obtained in person at the time of evaluation and through review of     their medical records. Investigators will obtain information on SCD-related clinical     complications and obtain an estimate of the number of lifetime RBC transfusions. Blood     samples will be obtained for laboratory tests. Plasma samples for hepcidin, growth     differentiation factor 15 (GDF -15), and high-sensitivity CRP will be stored at -80 degrees     Celsius until analysis. Other routine laboratory studies including complete blood count (CBC)     with differential and reticulocyte count, serum iron profile and ferritin, and liver function     tests will be performed at the clinical laboratories of UNC Hospitals.The subjects will have     30 ml. of blood drawn for this research study. Females of child bearing potential will have a     urine pregnancy test at the time of the study.   "
78455|NCT02258984|"     The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP     system has on the management of emergency department (ED) patients with fluid sensitive     conditions.   "
78456|NCT02258971|"     Primary objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites     CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion     pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180     BR      Secondary objectives: To determine safety and tolerability following single dose oral and iv     administration of BEA 2180 BR in healthy male volunteers.   "
78467|NCT02258828|"     Twenty six veterans with PTSD and cognitive impairment received 16 weeks of memantine in an     open label fashion. Cognition was assessed using the Spatial Span, Logical Memory I, and     Letter-Number Sequencing subtests of the Wechsler Memory Scale III (Third edition) and the     Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS measures     attention, language, visuospatial skills, and immediate and delayed memories. The Clinician     Administered PTSD Scale (CAPS), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale     (HAM-A), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and Sheehan     Disability Scale (SDS) were used to assess improvement in PTSD symptoms, as secondary outcome     measures.   "
78468|NCT02258815|"     A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m²) for five     consecutive days will be administered every 4 weeks, starting 60-180 days after previous     haploidentical stem cell transplantation.      Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants     will be premedicated with an intravenous antihistamine and ranitidine within approximately 30     minutes prior and during the infusion of the study agent Pain as an anticipated side effect     is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be     evaluated after 3 and 6 courses and after 1 year   "
78457|NCT02258958|"     Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in     significant morbidity, mortality and resource utilization. The true incidence is unknown, and     may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in     thoracic surgery includes administration of unfractionated or low molecular weight heparin     starting at the perioperative period and finishing at the time of patients' discharge. In     orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become     the standard of care. There is a clear need to systematically evaluate the incidence of VTE     after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in     preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung     resections. This study will involve patients undergoing lung resection for malignancy at St.     Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital.     The study will include 150 consecutively recruited patients. Study interventions will include     Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler     Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.      In summary, this study is aimed at evaluating, for the first time in a prospective manner,     the actual incidence of DVT and PE in patients undergoing major lung resections for     malignancies. The knowledge gained in this study will be used to inform a future     investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative     thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an     evidence-based practice change in VTE prophylaxis care for this high risk population.   "
78458|NCT02258945|"     Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for     diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin infusion     (CSII) is an effective method of achieving this. Among the advantages of CSII is the     opportunity for patients to potentially discard relatively inflexible mealtimes and     carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).     There are also reported improvements in quality of life. Furthermore, in patients with good     glycaemic control, such as those often assisted by CSII, various qualitative atherogenic     lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;     potentially leading to increased cardiometabolic risks. Literature examining the eating     behaviours, quality of life and cardiometabolic risks of CSII patients over time after     commencement of the therapy is sparse, frequently dated and worthy of further research.   "
78512|NCT02258243|"     This pilot randomized phase II trial studies how well photodynamic therapy using blue light     or red light works in treating basal cell cancer (carcinoma) in patients with a genetic     condition that causes unusual facial features and disorders of the skin, bones, nervous     system, eyes, and endocrine glands, also called basal cell nevus syndrome. Photodynamic     therapy uses drugs, such as aminolevulinic acid hydrochloride, that are taken up by tumor     cells and when exposed to an intensive light source (blue light or red light) become active     and may kill the cells. It is not yet known whether photodynamic therapy is more effective     with blue light or red light in treating basal cell carcinoma.   "
78460|NCT02258919|"     Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates     up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30     per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes     worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in patients     with malignant middle cerebral artery (MCA) infarction. Based on the common     pathophysiological mechanisms of these two conditions, this procedure is also frequently     performed in patients with ICH, but is has not yet been investigated in a randomized trial.      The primary objective of this randomized controlled trial is to determine whether     decompressive surgery and best medical treatment in patients with spontaneous ICH will     improve outcome compared to best medical treatment only.      Secondary objectives are to analyze mortality, dependency and quality of life. Safety     endpoints are to determine cause of any mortality and the rate of medical and surgical     complications after DC compared with best medical treatment alone.   "
78461|NCT02258906|"     Ulinastatin reduces systemic inflammatory responses and protects organs from     ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of     ulinastatin on postoperative renal function in patients undergoing robot-assisted     laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for     robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and     control (n=35) groups. Randomly selected patients of the ulinastatin group are given     ulinastatin. In contrast, patients in the control group receive an equivalent volume of     normal saline as a placebo. The primary endpoints are postoperative renal function measured     by serum creatinine, cystatin C, and urine output.   "
78462|NCT02258893|"     The purpose of this study is to determine whether reducing indoor exposure to NO2 and     particles improves respiratory health in children with asthma.   "
78463|NCT02258880|"     The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to     determine whether SUN13837 improves the physical performance, relative to placebo, following     an acute stroke in adult subjects.   "
78464|NCT02258867|"     The objective of this study is to assess the efficacy and safety of gevokizumab in treating     Behcet's disease uveitis (BDU).   "
78465|NCT02258854|"     The purpose of this study is to provide continued dosing of gevokizumab in order to obtain     and assess long-term gevokizumab safety data.   "
78466|NCT02258841|"     The purpose of this study is to assess the effectiveness of an interactive, online safety     decision aid among diverse Canadian women who are experiencing intimate partner violence     (IPV). The investigators will also explore how the online intervention works, and whether it     has different effects for different groups of women.   "
78469|NCT02258802|"     The purpose of this study is to develop, implement and evaluate a psychoeducational     intervention focused to improve nutritional status, specifically micronutrients, of mothers     and caregivers of children between the ages of 5 and 13 years and their children through     providing healthy cooking lessons in their communities.   "
78470|NCT02258789|"     There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using     virtual technology, a new method (virtual reality, VR method) has been created which focuses     on stimulating attention networks: top down scanning training in a 3D game, combined with     intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training.      Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as     well as before and after training with the new VR method Method:- An intense visio spatial     scanning training, enhanced by directed visual, audio and tactile stimulation cues and     feedback, also including visio-motor activation was designed in a VR game. The in-house     developed software was based on the Tetris game. The VR method consists of an interactive 3D     environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15     patients with chronic (>6 months) visio spatial neglect was included due to right-sided     ischemia. A VR neglect test battery including a Posner task were repeated three times during     a 5 weeks baseline before the training started (to establish the chronic state) and again     after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training     attention after stroke causing visio spatial neglect.      The method has been designed for home rehabilitation and is well suited for a tele-medicine     approach. It was built with standard components and is easy to manufacture at a low cost. The     idea is to give access to effective training, to make it available at the stroke unit with     the possibility for the patient to loan it it at discharge for home rehabilitation. The     concept of an all in one, easy-to-use device for testing, training and outcome evaluation     should be beneficial These preliminare results has been promising and indicates that the     RehAtt™ method could become an further developed into an effective and stimulating     intervention tool that would lower rehabilitation costs and reduce tiresome travelling to     hospitals for training.   "
78471|NCT02258776|"     The purpose of this study is to determine the efficacy of pomegranate extract and pomegranate     juice on skin inflammation and aging. The information gained from this study may lead to the     development of a pomegranate product that can decrease the effects of aging, inflammation and     harmful bacteria on the skin.      In this study, two pomegranate products (extract and juice) will be compared with a placebo,     a study product that looks like pomegranate extract, but contains no active ingredients.   "
78472|NCT02258763|"     To determine, in children hospitalized with pneumonia, if an extended duration of oral     antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in     improving clinical outcomes.      Secondary Aims:        1. Describe the prevalence of respiratory viruses and bacteria at presentation.        2. Investigate the depression, anxiety and stress scores (DASS21) and quality of life          scored (QOL) by parents of the children during admission, pre-discharge and post          discharge and at follow-ups.   "
78473|NCT02258750|"     This study will examine the impact of a soluble fibre (polydextrose) incorporated into a high     fibre tomato soup on food intake (amount and choice), appetite ratings and biomarkers of     satiation and satiety over 4-weeks. Specifically, the impact on the development of satiation     within the fixed-load tomato soup containing the fibre, the development of satiety after the     fixed-load meal containing fibre and intake at subsequent ad libitum meals will be examined     as well as the insulin response and carbohydrate fermentation before and after 4-week dosing     of the preload soup.   "
78513|NCT02258230|"     Compare operative times and complications of sacral colpopexy and paravaginal repair between     two-dimensional and three-dimensional laparoscopic systems.   "
78514|NCT02258217|"     Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)   "
78549|NCT02257736|"     The purpose of this study is to compare the radiographic progression-free survival (rPFS) of     apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone     (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any     chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate     cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of     sperm]).   "
78474|NCT02258737|"     Efficacy of transitional case management following psychiatric hospital discharge: a     randomized trial      Background The movement of deinstitutionalisation in Western societies has modified the role     of psychiatric hospital, which has lost its asylum function to become a place for acute care.      Psychiatric stays are now shorter and close interactions with the outpatient care network is     therefore more critical than before. The first weeks following discharge from psychiatric     hospital represent a period of high risk for relapse, readmission or even suicide. Case     management has a proven efficacy in facilitating patients' deinstitutionalisation after very     long hospitalisations and in stabilizing high users of psychiatric care. In contrast, studies     exploring the impact of time limited case management following discharge from short stays     (transitional case management) in earlier phases of psychiatric disorders in connection with     primary care are lacking.      Working Hypotheses The investigators hypothesize that transitional case management following     hospital discharge decreases risk of readmission, improves adherence to outpatient care,     facilitates recovery and improves patients' satisfaction with treatment as compared to     routine care.      Specific Aims In this study, the investigators will compare the impact of both intervention     on number of contact and level of adherence to outpatient care. The investigators will also     compare both groups on number of readmission, risk of early aggravation of the disorders,     level of functioning and satisfaction with care.      Methods This is a randomized single-blind study comparing transitional case management after     discharge with routine post-hospitalization care for subjects living independently without     institutional psychiatric follow-up. Demographic and clinical data will be gathered during     hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of     outcomes using validated instruments will be: contact and level of adherence to outpatient     care (primary outcomes), as well as number of hospitalization days, number of readmissions,     severity of illness and satisfaction with care (secondary outcomes).      Expected Value of the Proposed Project This study should improve psychiatric patients     follow-up in collaboration with the different levels of care in the global context of     deinstitutionalization.   "
78475|NCT02258724|"     Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the     children with congenital heart disease reach adult age.This results in an increasing number     of adults or grown-ups with congenital heart disease (ACHD or GUCH patients) that require     special health care organization and training programmes. Long term complications of these     GUCH patients and optimum treatment strategies are still poorly known. The aim of this     registry is to collect quantitative and qualitative data regarding GUCH patients treated in     specialised centres in Switzerland.   "
78476|NCT02258711|"     Bipolar disorder is a frequent condition in the general population with a high     morbimortality, which consists in dysfunctional temporal fluctuations between different mood     phases ranging from depression to manic episodes with frequent subsyndromal symptoms between     them. Usually during these phases, the subjects have a lack of insight about the diagnosis     and symptoms. Besides the pharmacological treatment, additional psychological interventions     have shown to improve the long-term outcome of the disorder, yet taking into account the     limited resources currently available, its general implementation is still difficult and     costly. Among these interventions, group psychoeducational programs have proved to be     cost-effective in helping patients recognize early signs and symptoms in order to prevent     full blown episodes which very usually are associated with a high morbidity and hospital     admissions.      On the other hand, numerous projects have tested the potential benefits of new technologies     such internet in the treatment of bipolar and psychotic disorders patients using either     online signs and symptoms monitoring or web-based psychoeducational programs, yet to the     investigators knowledge, none of them have integrated both approaches in one single     intervention.      The hypothesis that, combining both interventions (signs and symptoms monitoring along with     psychoeducational contents) in a single smart-phone application will prove to be at least     equal or superior in terms of efficacy comparing to the standard treatment, seems promising,     given the fact that both approaches have independently demonstrated their efficacy in the     same population. This could extend the range of the patients in whom this kind of additional     interventions could be implemented; preventing relapses, suicide attempts, consultations and     hospitalizations at a much lower cost.   "
78497|NCT02258438|"     The investigators propose in this project to determine the effect of 3 days of frequent     interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults     (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a     control condition where subjects do not exercise but are subjected to prolonged sitting. The     investigators believe that this proposed project will provide an initial evidence base for     the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity     activity, like walking.   "
78572|NCT02257424|"     The primary purpose of this study is to determine the maximum tolerated dose (MTD) and     preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral     dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.   "
78477|NCT02258698|"     BACKGROUND: Surgical injury and inflammation provoke a stereotypical stress response. Insulin     resistance plays an intriguing role in these metabolic alterations and depends on the     intensity of injury. Metabolic derangements resulting from peripheral insulin resistance are     unambiguously related to adverse outcomes and higher perioperative complication rates.     Therefore, insulin resistance offers to act as a marker for stress and is potentially     relevant in predicting clinical outcome. Plasma-glycosylated hemoglobin A (HbA1c) is an     established indicator for blood glucose control and has a prognostic value regarding outcomes     after major surgical interventions.      Adipose tissue holds a key function in endocrine metabolism by releasing multiple substances,     so-called adipose-derived secreted factors or adipokines. Recent studies have linked several     adipokines to overall insulin sensitivity in metabolic syndrome-related conditions as well as     in critical illness. Irisin, a recently identified myokine acts on white adipose tissue and     plays a role in the prevention of insulin resistance.      AIMS OF THE STUDY: The aim of this study is to assess the level and the effects of     perioperative insulin resistance on clinical outcome in cardiac surgery patients. Based on     previous studies suggesting glucose homeostasis and insulin resistance are associated with     severity of illness and outcome in critically ill patients,it is proposed that patients with     marked insulin resistance suffer from worse clinical outcome. This study protocol evaluates     the ability of homeostasis model assessment (HOMA), quantitative insulin sensitivity check     index (QUICKI), HbA1c, the adipokines Angiopoietin-like protein 2 (ANGPTL2), C-X-C motif     chemokine 5 (CXCL5), and visfatin, and the myokine irisin to indicate perioperative insulin     resistance and explores for correlation with adverse clinical outcomes after 30 days.      MATERIAL & METHODS: 325 patients admitted to the surgical intensive care unit after elective     on-pump cardiac surgery will be consecutively enrolled. Baseline characteristics and routine     blood samples will be assessed the day before surgery. Study blood samples will be drawn     preoperatively in the induction bay of anesthesia to measure the insulin resistance indices     HOMA and QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin, and irisin. Blood glucose, irisin,     adipokines, and routine biochemical tests will be assessed upon admission to the intensive     care unit and on postoperative days 1 and 3. Adverse outcomes will be assessed 30 days after     surgery. Sample size is set to ensure at least 80% power at a significance level of 0.05.   "
78478|NCT02258685|"     This study plans to learn more about immune responses in intestinal (gut) tissue in people     with human immunodeficiency virus (HIV) infection. This study will determine whether change     in the composition of gut bacteria in HIV infected individuals is related to a high     prevalence of chronic gut inflammation and metabolic disease. The investigators will also     investigate immune-modulatory properties of specific bacteria that correlate with disease     both by characterizing which functional genes are selected for in their genomes and by     stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This     work will establish whether gain/loss of bacterial drivers/suppressors of information in the     gut contributes to metabolic disease in HIV-infected individuals.   "
78528|NCT02258022|"     Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The     ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value. This     study is seeking to determine if the breath delta value of adults with trauma is an early     indicator of the onset of infection that may lead to sepsis.   "
78529|NCT02258009|"     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab     and aflibercept on systemic VEGF protein levels in DME patients in a detailed time course.   "
78480|NCT02258659|"     This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle     formulation) and carboplatin followed by response-based local therapy in treating patients     with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin,     hydroxyurea, fluorouracil, paclitaxel, and cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them spreading. Radiation therapy uses high energy x rays to kill tumor cells.     Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and     reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and     radiation therapy based on response (response-based therapy) and giving patients who are     responding well lower doses of treatment may help reduce the occurrence of side effects.   "
78481|NCT02258646|"     This research project aims to conduct a three-arm multi-center randomized controlled trial     (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive     pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term     integrated telerehabilitation involving exercise training at home, telemonitoring, and     education/self-management will prevent hospital readmissions, thus reducing healthcare costs,     for patients with COPD, and will improve patient status and quality of life.   "
78482|NCT02258633|"     The study will use a randomized controlled design testing the effectiveness of the following     intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The     study will identify children ages 2-14 at a pediatric trauma center. Children and their     parents who agree to participate in the study will then complete a screening survey to     identify part time seatbelt use. Those who screen positive will complete a more detailed     baseline survey and then be randomized to one of two study conditions. At one month, a follow     up assessment by telephone will be completed.   "
78483|NCT02258620|"     The radial approach for a coronary angiography is currently adopted by several centers     because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in     intra-arterial have been widely studied in prevention of this spasm. No studies have compared     the different routes of administration of nitrates as a patch and a continuous intravenous     injection.   "
78484|NCT02258607|"     This study is conducted in two phases. The Dose-finding Lead-in Phase, Part A, will evaluate     the safety and determine the maximum tolerated dose (MTD) of momelotinib (MMB) when combined     with trametinib. Once the MTD of MMB is determined, the study will proceed to the     Dose-finding Lead-in Phase, Part B, to determine the MTD of trametinib. After the MTD is     established, the study may proceed to an expansion phase to determine the efficacy, safety,     and tolerability of MMB combined with trametinib at the MTD in participants with kirsten rat     sarcoma viral oncogene homolog (KRAS) mutated metastatic non-small cell lung cancer (NSCLC).     Each treatment cycle will consist of 28 days and treatment will continue in the absence of     disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of     treatment.   "
78567|NCT02257489|"     This study will evaluate the safety and tolerability of single and multiple doses of ACE-083     as a local injection into selected skeletal muscles of healthy subjects. The study will also     determine the amount of ACE-083 that reaches the systemic circulation following local     administration. Additionally, the study will assess whether local administration into     skeletal muscle results in an increase in the size and/or strength of the injected muscle.   "
78485|NCT02258594|"     The purpose of this project is to refine, implement, and evaluate a multi-component     intervention that achieves sustainable and meaningful impact on healthcare quality, safety,     and costs while ensuring dignity and respect for adult oncology and intensive care patients     and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through     Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this     by enhancing the patient-provider relationship and introducing patient-centered approaches to     multi-disciplinary communication and patient education. The PROSPECT framework is based upon     a validated structured, team-work training model and novel web-based technology. The     overarching goals of this project are to achieve the following:        1. Optimize the overall experience of patients (including their family/care partners) by          promoting dignity/respect, encouraging engagement, improving care plan concordance, and          enhancing satisfaction.        2. Minimize preventable harms in two environments: intensive care and acute care oncology          units.        3. Reduce unnecessary healthcare resource utilization and associated costs.   "
78486|NCT02258581|"     This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the     HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only     individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).   "
78487|NCT02258568|"     This study will assess the extent of postpartum smoking relapse among Romanian women, the     associated risk factors, and will develop, implement, and pilot-test a randomized trial     smoking relapse intervention incorporating innovative research concepts in a social and     cultural acceptable manner. The primary hypothesis is that the intervention will increase     mothers' smoking abstinence rates.   "
78488|NCT02258555|"     This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with     follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL),     or small lymphocytic lymphoma (SLL). The study will also characterize the pharmacokinetic     (PK) profile of GS-9901, determine the appropriate dosing regimen of GS-9901 for use in     future clinical trials, and to evaluate the efficacy of GS-9901 monotherapy in adults with     FL, MZL, CLL, or SLL.   "
78489|NCT02258542|"     The purpose of this study is to characterize the safety profile of benralizumab     administration in asthma patients who have completed one of the three predecessor studies:     D3250C00017, D3250C00018 or D3250C00020.   "
78543|NCT02257814|"     The purpose of this study was to deepen the evidence base for interventions that support the     social-emotional skills that underlie children's engagement and attention to learning tasks     by schools (learning behaviors) and their social interactions with teachers and peers (social     behaviors). The study tested three theoretically-distinct approaches to enhancing children's     social-emotional development, along with a comprehensive coaching and training model, on a     large scale within the Head Start system.   "
78490|NCT02258529|"     The primary objective of this study is to evaluate the overall response rate (ORR) and     complete response (CR) rate to treatment with idelalisib in combination with rituximab in     previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma     (SLL).      An increased rate of deaths and serious adverse events (SAEs) among participants with     front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma     (iNHL) treated with idelalisib in combination with standard therapies was observed by the     independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3     studies. Gilead reviewed the unblinded data and terminated those studies in agreement with     the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).     All front-line studies of idelalisib, including this study, were also terminated.   "
78491|NCT02258516|"     Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of a     new, theoretically based intervention to improve medication adherence in persons with HF. The     hypotheses include:      Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention     (n=40) will be more adherent to medicines during the12-month intervention than a control     group (n=40) of poorly adherent patients with symptomatic HF.      Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention     (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits during     the 12-month intervention than a control group of poorly adherent patients with symptomatic     HF.      Study Activities and population - A prospective, randomized controlled design will be used to     pilot test the efficacy of a new intervention to promote adherence to the medication regimen     in chronic heart failure in the clinical setting. The initial development and feasibility     testing of the intervention is complete (Preliminary Work, Section 4.5).      Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor adherence,     as determined by a validated screening measure, the Medication Adherence Scale (MAS)89 at     baseline assessment, will be recruited and randomized to receive the intervention or usual     care with attention control. Medication adherence, symptom frequency and intensity, hospital     readmissions (HR) and emergency department (ED) visits will be assessed in both groups at 3,     6 and 12-month clinic visits. The intervals between visits are considered sufficient to     minimize sensitization bias to psychometric measures. Longitudinal measurement is required to     evaluate the magnitude of change in adherence and symptom-related events occurring over time.     Efficacy will be measured as improved adherence (primary outcome) and decreased HR and ED     visits (secondary outcomes) in the intervention group as compared to the attention control     group at 12 months. The study will close when all patients have had a 12-month     post-enrollment clinic visit.      Data Analysis & Safety/Risk Considerations - The investigators will use generalized linear     models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic     generalizations of the traditional, multivariate GLM are appropriate when the dependent     variable is binary and the probability of an event is modeled, as is the case with adherence     in this study. When the dependent variable is a count, a commonly used generalized model uses     the natural logarithm of the count, as with re-hospitalizations and ED visits in this study.     In compliance with NIH guidelines for data safety and monitoring activities, a number of     quality control steps will be used to ensure the on-going safety of participants and the     scientific integrity of this feasibility intervention study. The proposed study poses only     very minimal risks to participants. All participants will receive usual care. Participation     in the study will not replace patients' regular health care attention. Data safety will be     monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study     co-investigators. Any adverse events will be reported immediately to the Duke IRB and the     NIH.      Data Safety. First, a project database will be constructed, using participant ID numbers and     including all demographic, pre- and post-intervention history and all assessment materials. A     separate file, cross-referencing participant identification with project ID numbers, will be     maintained with access limited to the PI or a designated member of the investigative team.   "
78492|NCT02258503|"     The pain of the elderly is even often unrecognized or trivialized and ignored in spite of its     big frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of     those living in institution and 80 % of this population at the end of life.      So in the elderly, the noxious character of the pain is more pregnant than at the young     adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to     deteriorate the isolation and the dependence: the echo on the psychic state is frequent and     the pain is a part of the cause of a confusional state. Finally, the presence of a pain     distorts considerably the quality of life and can modify the state general as the desire of     life.      The evaluation of the pain appeals to the same strategy as to the younger subject but with     some specificities, related more to the pathologies associated with the ageing than with the     real age. For that purpose, the investigators have first of all scale of self-assessment as     the numerical scale which is adapted to estimate the acute and chronic pains but this scale     presents a bias because, certain patients do not express spontaneously their pain and this     one must be attentively looked for in case of modification of behavior.      So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to     care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow within     one minute a good quality evaluation whatever is the place of care) whose objective is the     observation of the behavioral changes caused by the acute pain in elderly having     communication disorders.      Due to the demographic evolution, emergency departments are more and more frequently a place     of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of all     the passages in emergency department and 50 % of the patients hospitalized during the passage     in the reception of Emergency department are elderly. Elderly care is difficult for a certain     number of reasons (vulnerability, accumulation of pathologies and treatments). So, in this     context, the evaluation of the presence of pain and its care are difficult in particular at     the elderly with communication disorders.      In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on     700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of     analgesic while 13 % only had a real quotation of the pain.      The aim of the investigators study is to analyze if the systematic introduction of the scale     Algoplus® in the evaluation of elderly during its entrance to emergency department could     modify the prescription of analgesic.   "
78493|NCT02258490|"     Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment     for hematological abnormalities. Poor graft function, occurs when there poor donor     engraftment. A second infusion of unselected donor hematopoietic stem cells (HSC) can result     in improvement, but can potentially increase the incidence of graft versus host disease.     Cluster of differentiation 34+ (CD34+) selected stem cells depleted of T-cells is an     attractive alternative for treatment of poor graft function as it may be associated with less     Graft versus Host Disease (GVHD) and enhanced count recovery. The investigators are using the     Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of allogeneic     hematopoietic progenitor cell (HPC) transplants for patients who have had prior stem cell     transplants and require a stem cell boost from the original donor.   "
78494|NCT02258477|"     To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a     non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test     whether there is a threshold of glucose that will result in improved ease of resistance to     problem foods (tested by comparing three different levels of glucose).   "
78495|NCT02258464|"     The objective of this study is to assess efficacy and safety of radium-223 dichloride in     subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone     receptor positive breast cancer with bone metastases treated with hormonal treatment     background therapy.   "
78496|NCT02258451|"     The objective of this study is to assess efficacy and safety of radium 223 dichloride in     subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor     positive breast cancer with bone metastases treated with exemestane and everolimus.   "
78498|NCT02258425|"     In Phase I of this R34, the team from the University of California Los Angeles, San     Francisco, and Irvine researchers plan to utilize the successful community participatory     approaches to refine a gender-sensitive criminogenic needs -focused intervention program,     Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board,     composed of homeless female offenders (HFOs) and addiction staff; and finalize strategies     which will be validated by focus group sessions with the HFOs. In Phase 2, the research team     will randomize 130 HFOs participating in one of two residential drug treatment programs to     assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug     and alcohol use and recidivism. This study is based upon our team's history of promoting     theoretically-based, culturally sensitive nurse-led interventions that are enriched with     criminal justice theoretical perspectives, and have resulted in significant reductions in     drug and alcohol use among homeless persons, many of whom have had a history of     incarceration.      Specifically, the study aims are:      AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff,     further conceptualize our community-based program, Female Ex-Offender Mentoring in Care     (FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine     the program in focus group discussions with 12 HFOs.      AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at     six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program,     in terms of a) self-reported and/or objective measures of drug and alcohol use; and b)     prevalence of recidivism and number of days to first reincarceration.      Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six months     than HFOs in the HP control program.      Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and     greater number of days to first reincarceration than HP control HFOs.   "
78499|NCT02258412|"     This study will evaluate the immediate antimicrobial efficacy and persistence of two hand     hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on     hands using the hand print method. It is hypothesized that the product containing     Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in     less bacterial growth on the hand print plates. In addition, environmental monitoring for     cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas     using Rodac plates and adenosine triphosphate tests.   "
78500|NCT02258399|"     The ability to control our blood glucose (sugar) concentrations after a meal is a strong     predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the     amount of glucose from the liver entering the bloodstream. At the same time muscle increases     the amount of glucose it take up from the bloodstream. This ensures that our blood glucose     levels do not get too high. The investigators want to understand what happens to these     processes following exercise after breakfast and after an overnight fast. In addition, the     investigators also want to understand whether exercising with or without breakfast influences     our appetite, food intake and activity levels later in the day.   "
80545|NCT02231645|"     The purpose of this study is to evaluate whether subthalamic deep brain stimulation (STN DBS)     can affect moral and economic decisions in patients with Parkinson's disease (PD).   "
78501|NCT02258386|"     The aim of the present study is to implement a novel body-worn sensor, the ZephyrTM BioModule     (the registered name for the wearable sensor device used in our study), for assessing     physical activity and physiological measures in a clinical setting together with other     clinical routine assessments. Our specific aim is to explore whether and how specific     physical activity pattern and physiological measures are associated with delirium in hospital     inpatient. Our ultimate goal is early detection and intervention of delirium, and better     management through monitoring of activity pattern and physiological information. The ZephyrTM     a U.S. FDA-approved wireless, ambulatory physiological monitoring device that consists of a     data logger and transmitter unit which is attached at the location of the 5th intercostal     space using a specifically designed patch (BioPatchTM) and standard ECG electrodes. The     ZephyrTM is designed for long-term measurement of a patient's physical activity and     physiological measures. By using the physical activity parameters and physiological measures,     a specific delirium risk profile will be computed for each patient. Finally, the association     of this delirium risk profile with CAM-ICU questionnaire as a gold standard will be assessed.   "
78502|NCT02258373|"     The primary objective of the study is to determine whether the routine use of Continuous     Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and     effective as CGM used as an adjunct to BGM.   "
78503|NCT02258360|"     This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48,     ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic     hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac     arrest.      The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after     cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia      Our specific aims are:        -  To investigate the whole blood coagulation using the rotational thromboelastometry.        -  To investigate the function of platelets   "
78504|NCT02258347|"     Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid     nodules.   "
78505|NCT02258334|"     The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015     formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65     years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone®     High-Dose vaccines in adults ≥ 65 years of age.      Objectives:        -  To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone          Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2014-2015          formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65          years of age.      Observational objectives:        -  To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent          and Fluzone® Intradermal vaccines in adults 18 to < 65 years of age and the          immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone          ®High-Dose vaccines in adults ≥ 65 years of age.        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone®          Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group          with the historical requirements of the Committee for Human Medicinal Products (CHMP)          Note for Guidance (NfG) CPMP/BWP/214/96.   "
78506|NCT02258321|"     This study will compare the blood levels of PPI-668 resulting from two different formulations     - the current capsule and a new tablet, T003.   "
78507|NCT02258308|"     Asthmatic children age 3-17 from low income households in King County are randomly assigned     into a community health worker (CHW) intervention group and a control group. The intervention     is in-home education and support related to asthma self-management. The main outcome measures     are asthma symptom-free days, caretaker's asthma-related quality of life score, and health     care utilization for asthma measured at baseline and 12 months after baseline enrollment.   "
78719|NCT02255474|"     This study will evaluate the use of two different bifocal contact lens add powers to prevent     further nearsighted progression in children ages 7 to 11 years old. It is theorized that the     profile of the bifocal lenses will decrease the amount of change in nearsightedness that the     children experience.   "
78508|NCT02258295|"     This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of     hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally     been used to treat knee osteoarthritis. There are a small number of studies in the literature     that suggest that HA injections can be very effective for tendinosis. Although LE has been     studied with literally hundreds of articles published, very little treatment has proven to be     efficacious. This study will investigate the effectiveness of hyaluronate in treatment of     chronic LE. This will include a two arm study with one formulation of HA tested against     saline injections as the control.   "
78509|NCT02258282|"     The purpose of this study is to evaluate safety and efficacy of etanercept in patients with     psoriasis who had an unsatisfactory response to traditional DMARDs.   "
78510|NCT02258269|"     The purpose of this study is to observe the effect of square dance on rheumatoid arthritis.   "
78511|NCT02258256|"     The purpose of the study is to help make a lower cost automatic blood pressure monitor device     for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood     pressure monitoring is limited or not available. The study will compare this low cost device     to a commercially available system used for pre-eclamptic women in many United States     hospitals that the investigators will be bringing to Malawi as a part of this study.      The team hopes to show that this lower cost blood pressure machine works well and can help     women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to     use.      20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen     Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the     subject and the commercially available cuff on the opposite arm. A trained research assistant     and the nurse will record the blood pressure measurements and document any alarm indications     made by each device. Blood pressure measurements will continue until monitoring is no longer     clinically prescribed.      The results of this study will help researchers understand the performance and usability of     this device in Malawi and help decide if any design changes are needed.   "
78550|NCT02257723|"     This study investigates the effect of hospital-based intensive non-surgical treatment in     musculoskeletal patients admitted to an integrated hospital that offers both complementary     and alternative medicine (CAM) and conventional medicine treatment.   "
78515|NCT02258204|"     KETA trial is a nonprofit, double-blind, randomized, controlled pilot trial with aiming to     determine if co-administration of ketamine with recombinant of tissue type plasminogen     activator (tPA) for thrombolysis in acute ischemic stroke compared with tPA co-administered     with placebo, decreases cerebral infarction growth in diffusion weighted imaging between     admission and day 1. Eligibility applies to patients with symptomatic ischemic stroke seen     within 4.5 h of onset with middle cerebral artery or distal internal carotid artery     occlusion, no contraindication to intravenous tPA-mediated thrombolysis and eligible to     endovascular treatment of stroke (i.e. thrombectomy). The study has been designed to have 80%     power to detect a 80% decrease of infarct volume growth in the tPA-ketamine group at a     two-sided type I error rate of 5%. For this purpose, at least 25 patients per arm should be     enrolled.   "
78516|NCT02258191|"     Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive     ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.      Multicentric Randomized Controlled Trial      Primary Objective:      To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term     treatment efficacy and patient compliance      Secondary Objectives:      To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To     carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with     NIV   "
78517|NCT02258178|"     The goal of the registry is to develop a better understanding of the safety of Flucelvax in     women and their offspring who were exposed to the vaccine during pregnancy   "
78518|NCT02258165|"     This study will be the first prospective study enrolling consecutive patients with advanced     ovarian cancer to determine the prevalence of thoracic and extra-abdominal involvement in     this patient group and the relative value of gated PET and CT for diagnosing extra-abdominal     involvement. This study will also answer a number of other stil unanswered questions: the     impact of gating and the impact of gated PET on clinical management of patients with advanced     ovarian cancer. This study also individualises patients' treatment to allow patients who may     benefit most form optimal surgical cytoreduction and those who are better treated by     neoadjuvant   "
78519|NCT02258152|"     The purpose of this study placebo-controlled, randomized, double-blind study is to assess the     safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already     treated with a stable dose of a cholinesterase inhibitor.   "
78520|NCT02258126|"     The objective of the present study is to evaluate the effect of 6 months exercise     intervention program on hepatic fat fraction in overweight children.      Methodology: A total of 160 children, 9-11 years old, will be randomly assigned to control     (N=80) or intervention (N=80) groups. Training sessions will include 90 minutes of exercise,     comprising warm-up and skill development. The control group will attend a healthy lifestyle     education program (2 days/month) and the intervention group an exercise (3 days/week) and     healthy lifestyle education (2 days/month) combined program. Before and after the     intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk     factors will be measured. Furthermore, dietary habits and physical activity, blood pressure     and pubertal development will be evaluated before and after the intervention.   "
78720|NCT02255461|"     This phase I trial studies the side effects and best dose of palbociclib isethionate in     treating younger patients with central nervous system tumors that have grown, come back, or     not responded to treatment. Palbociclib isethionate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
78521|NCT02258113|"     The aim of this study is to measure visual acuity and contrast sensitivity using a novel     reaction-time based visual field device Ocusweep compared to widely used methods. Addition to     that. the aim is to validate a novel perimetry method (Visual Search Test, VST) which is     based on reaction times in visual decision-making task, where the subject is allowed to move     eyes and where the fixation is verified by the subject himself in contrast to standard     automatic perimetry (SAP) where prolonged stationary fixation and external fixation     monitoring apparatus is required. using a novel reaction-time based visual field device     Ocusweep compared to generally used SAP methods. Those tests will be done for healthy     volunteers and for persons with diagnosed eye or brain disease.   "
78522|NCT02258100|"     To date the effect of AIMS on medical interventions has not been studied. We seek to     retrospectively evaluate paper and electronic anesthesia records among a single surgical     population (esophageal surgery) to ascertain any differences that may exist between cohorts     with regards to chart completion, anesthetic management and medical care.   "
78523|NCT02258087|"     Investigators compare in a randomized clinical trial the results and side effects of     high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ     confined prostate cancer patients.   "
78524|NCT02258074|"     The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and     lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients     with Chronic Kidney Disease (CKD) stages 3-4.   "
78525|NCT02258061|"     The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known.     Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve     function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).   "
78526|NCT02258048|"     This is a prospective study designed to examine the role of transient elastography as a     predictor of clinical decompensation in patients with early cirrhosis. The study objective is     to determine if changes in measurements of liver stiffness with transient elastography can     identify patients that will have a more rapid progression of cirrhosis and the development of     clinical decompensation. The target population is patients with early stage, well-compensated     cirrhosis.      Participants of this study will be asked to complete the following procedures: read and sign     the informed consent, medical records review (complete medical history, physical examination,     laboratory evaluation, endoscopic findings, radiographic findings), undergo transient     elastography to measure liver stiffness every three months until the development of clinical     decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic     encephalopathy) for up to 2 years.   "
78527|NCT02258035|"     The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human     volunteers and use these purified proteins to cross-validate existing or novel assays for     this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc     for different vitamin D metabolites.   "
78530|NCT02257996|"     Objective: To evaluate the effectiveness of online systematic brief psychodynamic     psychotherapy (SBPP) via HIPAA compliant web conferencing on adults with neurotic disorders.      Design: Randomized controlled trial. Single blind.      Setting: Internet users in the community, in São Paulo, Brazil.      Participants: Thirty-two adults will be randomly allocated to a group will receive online     systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16).      Method: Systematic adaptative diagnosis system will be applied in both groups at     pre-treatment and post-treatment (or post-waiting list). Assessment will be a comparison of     the adaptative diagnosis evolution between groups.      Primary Outcomes: The subjects treated with online brief systematic psychodynamic     psychotherapy will present an increase in their adaptative efficacy measured by systematic     adaptative diagnosis scale (SADS) in comparison to the waiting list group, when contrasting     their initial and final adaptative diagnostics.   "
78531|NCT02257983|"     If effective, administration of EPI-743 should have protective effects against temporary     noise-induced hearing loss.   "
78532|NCT02257970|"     This study compares the effectiveness of a study drug versus placebo in the treatment of     lymphedema to the untreated condition, in the same individual..   "
78533|NCT02257957|"     Dry eye is a chronic condition that decreases function and affect visual function with severe     discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has     emerged as a strategy for cellular restoration, the purpose of this study is to evaluate     their effects in lacrimal production and safety of this intervention in patients with severe     dry eye.   "
78534|NCT02257944|"     The purpose of the study is to develop a program to help people to lower their chances of     being violently injured again.   "
78535|NCT02257931|"     A significant increase in resistant bacteria emerging in HSCT recipients. For example, 25% -     42% of all enterobacteriaceae produce extended spectrum beta-lactamases; 8 - 72% of     Pseudomonas aeruginosa are resistant to at least one and 25 - 62% to three or more antibiotic     classes, 13% of Gram-negative bacteria are caused by a multidrug-resistant (MDR) strain     (Trecarichi JI 09, Mikulska BBMT 09, Oliveira BMT 07, Caselli Haemat 10, Gudiol, JAC 11).     These resistant bacteria may be associated with increased mortality and have limited     treatment options (Caselli Haemat 10, Poutsiaka BMT 07, DiazGranadoz JID 05). To provide the     currently best empirical coverage and to control the growing resistance, knowledge of trends     in antibiotic susceptibility, as well as risk factors is essential. For this reason we     propose to perform non-interventional prospective multicentre study in EBMT centres.   "
78568|NCT02257476|"     The purpose of this study is to find the safest dose level of an approved drug, carfilzomib,     in solid tumors when given over a different period of time than normally used. The study will     also use markers in blood from routine blood draws to help check the levels of the drug.     Lastly, the study will check how well this drug works with regards to keeping cancer cells     from growing with the new time frame of delivery.   "
78536|NCT02257918|"     This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male     and female subjects, between the ages of 18 and 55, who are in good health and meet all     eligibility criteria. The study is designed to assess the safety and efficacy of an     antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to     adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone.     Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of     AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name is     also known as ETX0914.   "
78537|NCT02257905|"     Light-chain (AL-) amyloidosis is a very rare monoclonal plasma cell disorder with poor     prognosis. Rarity of disease has precluded performance of randomized controlled trials     comparing various possible treatment modalities. In general, treatment of AL amyloidosis has     been adapted from myeloma (MM) therapy. There is large experience with allo SCT in MM. Based     on small series of patients and case reports allogeneic transplant has emerged as potentially     effective. However, more formal proof of concept of using allogeneic hematopoietic     transplantation for treatment of AL Amyloidosis is lacking.      Therefore, given the limitations of conventionally collected registry data (dubious follow-up     information and extreme heterogeneity), we developed the: EBMT non-interventional     prospective study on allogeneic transplantation in AL Amyloidosis which means that     transplant centers that already do perform allogeneic transplants for AL Amyloidosis will be     encouraged to register their patients with AL Amyloidosis very timely with the EBMT, followed     by mandatory submission of EBMT MedB and follow-up forms. The diagnosis of AL Amyloidosis     would be based on uniform criteria. All EBMT centres performing allogeneic transplants for     Amyloidosis will be invited to participate in this study and centres will be asked to report     all AL Amyloidosis cases referred for transplantation using a simple registration form and     then to submit Amyloidosis MED B forms for each transplanted patient and follow-up forms as     necessary. In conclusion, it should be possible to largely improve the usual quality of     registry-based data and to generate scientifically sound knowledge on HSCT in an orphan     disease such as AL Amyloidosis.   "
78544|NCT02257801|"     The purpose of this study is to study effects of a four months lutein supplementation (in     form of a lutein fortified nutritional beverage) on general learning and memory performance     as well as on acute stress-induced changes in learning and memory performance in chronically     stressed males and females using 2 different lutein doses in comparison to a placebo.   "
78545|NCT02257788|"     PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female     adult subjects infected with CCR5-tropic HIV-1.   "
78546|NCT02257775|"     The objective of this study is to apply Whole-body DW imaging alongside the routine     management of patients requiring systemic therapy for metastatic breast cancer to compare the     time to progression of individual liver metastases within and between patients following     stable disease or partial response to palliative systemic therapy for breast cancer.   "
78547|NCT02257762|"     The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17 months     in preventing growth faltering and improving micronutrient status. The impact of product will     be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group consuming an     unsupplemented diet, which is usually borbor at an early age, and thereafter, family foods.   "
80546|NCT02231632|"     The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live     attenuated Poliomyelitis vaccine (human diploid cell)   "
78538|NCT02257892|"     Background:      - The immune system helps the body fight infection and disease. People with immune system     problems can get infections, blood disorders, and other health problems. Researchers want to     learn more about the immune system, like what causes it to not work properly.      Objectives:      - To evaluate people with certain types of immune system disorders.      Eligibility:      - Adults and children with an immune disorder or symptoms of one, and their relatives. Some     disorders are not included in this study.      Design:        -  Researchers will review participants medical records.        -  Participants may mail in a blood or saliva sample, or be evaluated at the clinic. At the          clinic, they may have a medical history, physical exam, blood tests, and imaging scans          (with dye given through a needle in the arm). They may have genetic testing done on a          sample of blood, saliva, hair, or nail clipping.        -  Participants may choose to have a skin biopsy. Up to 2 skin samples will be taken from          their arm, back, or other area. A biopsy punch is inserted into the skin and rotated. A          small circle of skin is removed.        -  Participants 10 and older may also choose to have leukapheresis. Blood is taken through          a needle in one arm. It passes through a machine that separates the white blood cells.          The rest of the blood is returned by needle in the other arm.        -  Researchers may recommend medicines, but no treatments are being studied.        -  Participants may be invited to return for visits over several years. At those visits,          they may repeat some or all of the above tests. Or they may mail in blood or other          samples. They may also send medical records.   "
78539|NCT02257879|"     Background:      - Drinking grapefruit juice changes how long it takes some medicines to be broken down in the     body. Researchers have found that a substance in grapefruit juice called DHB contributes to     this effect. Some dietary supplements contain DHB and claim to increase the absorption of any     and all supplements, medicine or any other drug. But these usually contain a lot more DHB     than a glass of grapefruit juice. Researchers want to study the effects of grapefruit juice     and supplements with DHB.      Objective:      - To compare how a certain dietary supplement (sold as DHB-300 ) versus grapefruit juice     affects how long it takes a person s body to break down medicines.      Eligibility:      - Healthy volunteers ages 18 - 60.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests.        -  Participants will have 3 treatment visits. Participants cannot drive themselves home          from the visits. Each visit lasts about 13.5 hours and includes:        -  Questions about medications and participant s health.        -  Vital signs taken.        -  A finger probe to measure oxygen.        -  Blood and urine sampling throughout the visit.        -  An IV line inserted into an arm vein. It will stay there throughout the visit.        -  Study treatments:        -  Midazolam hydrochloride a syrup given to make people sleepy.        -  Loperamide a tablet for treating diarrhea.        -  1 glass of water, 1 glass of grapefruit juice, or 1 pill of DHB-300. A different one          will be given at each treatment visit.        -  One week before each visit, participants cannot have certain fruits and juices. They          must fast the night before each visit.        -  For the 3 days after each visit, participants will return to the clinic 4 times. Their          vital signs will be checked and blood will be drawn.   "
78540|NCT02257866|"     Background:      - Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can     cause many medical problems. Few tests can diagnose the disease, and none can reliably     predict a relapse. Researchers want to study people s genes and follow people over time to     see how the disease affects them.      Objective:      - To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can help     identify people with vasculitis and predict what will happen to them over time.      Eligibility:        -  People age 5 and older who have or are thought to have vasculitis, or are related to          someone with it.        -  Healthy volunteers.      Design:        -  Participants will be evaluated by a doctor who has expertise caring for patients with          vasculitis.        -  Participants will give a blood sample. Some will give a urine sample.        -  Some participants may have brushings or biopsies taken from the inside lining of the          nose.        -  Images of participants blood vessels may be taken using scans. For some scans,          participants will lie on a table that moves in and out of a cylinder that takes          pictures. For some scans, a contrast agent may be injected into an arm vein. Other scans          may use a radioactive form of sugar. Healthy minors will not have scans.        -  Some participants will answer questionnaires. - Some participants will have their tests          done at NIH. Others will have their doctor take the blood, saliva, or cheek swab samples          and send them to NIH.        -  Some participants will have one visit lasting 1 2 (but sometimes up to 4) days. Some          participants may have follow-up visits every 3 6 months, indefinitely.   "
78569|NCT02257463|"     The aim is to study effectiveness of inspiratory muscle training as a part of exercise     training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to     general exercise training program in regard to respiratory muscle strength, dyspnea, exercise     performance and quality of life.   "
78541|NCT02257853|"     Background:      - People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they     recover. Being a caregiver can be stressful to the body and mind. Researchers want to find     ways to reduce this stress.      Objective:      - To see how a stress reduction intervention affects the stress levels and health of an HSCT     caregiver.      Eligibility:      - Adults age 18 and older who plan to be an active caregiver for a person having their first     allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring     for the person from just before admission for the HSCT until at least 6 weeks after.      Design:        -  Participants will be put in either the intervention group or the control group.        -  All participants will get the usual caregiver education given to all patients and          caregivers having a stem cell transplant at the NIH Clinical Center.        -  All participants will have 2 study visits. They will give blood samples. They will have          health assessments and brief physical exams. They will fill out study questionnaires and          have an exit interview.        -  The intervention group will get an MP3 player. It will have an audio file with a stress          reduction intervention on it. Participants will do this intervention daily. It takes 20          minutes. They will do gentle stretches and breathing exercises. They will get a diary to          track their practice.        -  The intervention group also will have follow-up phone calls 2 and 4 weeks after their          first clinic visit.        -  The person getting the HSCT will not be actively involved in the study.        -  The study will last about 2 months.   "
78542|NCT02257827|"     There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus     the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data     from retrospective studies show that IMRT reduces the risk of severe late complications. More     recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in     reducing acute toxicity for prostate cancer treated with conventional dose escalation.     Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a     hypofractionated schedule in prostate cancer, the investigators developed a RCT.   "
78551|NCT02257710|"     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to     long-term complications range from rather immediate elastic coil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),     designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis     rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS     substantially reduced the incidence of abrupt artery closure, but restenosis still occurred     in about 20 to 40% of cases, necessitating repeat procedures.      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by     adding an antiproliferative drug (directly immobilized on the stent surface or released from     a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS     with systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease.      Therefore this observational registry has been designed for the clinical evaluation of the     ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and     collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting     Stent System in an all-comers patient population in daily clinical practice.   "
78552|NCT02257697|"     To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is     non-inferior to that of standard therapy CTX through analyzing overall remission rate after     treatment.   "
78553|NCT02257684|"     The purpose of this study is to evaluate the effectiveness,safety, and dosage of     pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma     (LBL).   "
78554|NCT02257671|"     The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood,     sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400     healthy women will be randomized to OC or placebo for a period of three months. Before and at     the end of treatment, mood and sexuality will be assessed by validated instruments. At the     end of treatment, each woman will participate in behavioral experiments testing     self-confidence, risk taking and altruism. The current project could fill the gap of     ignorance about causal effects of OCs on mood, sexuality and behavior. The results might     improve current practice as regards information about OCs, choice of hormonal contraceptive,     regimen and duration of use. As a consequence, this could lead to reduced discontinuation     rate, fewer unintended pregnancies and abortions. The project will contribute to an overall     improvement in women's reproductive health.   "
78555|NCT02257658|"     This pilot study will investigate the feasibility of conducting a large, randomized trial     comparing a structural intervention to contingency management to reduce incident syphilis     infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have     had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive     either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.     The investigators will : 1) measure adherence to study visits in both arms; 2) measure     adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study     participants and 4) to the extent possible in a small pilot study of short duration, compare     effectiveness of doxycycline with that of a monetary incentive for remaining STI free.   "
78556|NCT02257645|"     A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active     primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus     influenza type B in infants.   "
78557|NCT02257632|"     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab     and aflibercept on systemic VEGF protein levels in treatment naïve wAMD patients in a     detailed time course.   "
78558|NCT02257619|"     The purpose of this study is to determine if INCB039110, in combination with docetaxel, is     safe and effective in the treatment of non-small cell lung cancer (NSCLC).   "
78559|NCT02257606|"     With this randomised intervention study, the investigators want to investigate the training     effect of an 8 week training regime, using a robot-assisted training system in persons with     MS. Besides conventional therapy, study participants in the experimental group will train 3     times per week during 30 minutes, using the haptic master. Research questions focus on the     effects of additional robot assisted training on range of motion, movement quality and     clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires     and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16     weeks of follow-   "
78560|NCT02257593|"     The purpose of this study was to evaluate whether birth weight is related to the demand for     dietary protein in adult survivors of severe acute malnutrition (Kwashiorkor and Marasmus),     and that leveraging of protein intake is associated with total energy intake and weight     change in the survivors consuming foods with different percentages of energy as protein     (PEP).   "
78561|NCT02257580|"     E-Aminocaproic acid (EACA) is an anti-fibrinolytic agent that is used to decrease blood loss     and transfusion requirements after several orthopedic procedures. The aim of this prospective     double-blind placebo-controlled randomized trial is to determine whether IV EACA reduces     intra-operative calculated total blood loss in patients undergoing bilateral varus rotational     osteotomy (VRO). This study will also investigate intraoperative cell saver utilization,     transfusion of allogeneic blood, hospital length-of-stay (LOS), short term complications, and     long-term outcomes.This study will provide Level I evidence and has the potential to improve     outcomes in children undergoing this procedure.   "
78562|NCT02257567|"     This study is a multicenter, open-label study of polatuzumab vedotin administered by     intravenous (IV) infusion in combination with standard doses of bendamustine (B) and     rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular     lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a     Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18     weeks for participants with DLBCL and 24 weeks for participants with FL.   "
78563|NCT02257554|"     The goals of this study are to assess concordance between the patient-surgeon pair regarding     expectations of lumbar spine surgery.   "
78604|NCT02256995|"     A prospective observational study to test the feasibility of smartphone enabled uChek     urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in     urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess     attitudes of clinicians towards uChek as a new technology for urinalysis.   "
78564|NCT02257541|"     The goal of a phase Ib clinical trial is to find the doses of drugs that are safe. Although     BGJ398 has been given to patients safely on its own, it has never been given together with     imatinib mesylate. In this study, we will test the safety of taking BGJ398 with imatinib     mesylate. The investigators will learn this by closely checking for side effects that the     patient may experience. Side effects can be seen in laboratory studies, on physical     examination, or by asking the patient.Once a dose has been determined to be safe, a larger     Phase II study will be done in patients with advanced GIST who have never received any prior     treatments.   "
78566|NCT02257502|"     After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50     years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown.     This is a rare and severe disease, which can lead to blindness.      ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)     therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated     in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not     need as many injections as in AMD.      INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment     with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage regimen     is designed to achieve maximum efficiency. The patients are followed on a monthly basis until     52 weeks. Intravitreal injections of aflibercept are initiated with a Treat & Extend (TAE)     regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV     activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in     case of CNV activity).   "
78573|NCT02257411|"     After institutional ethics board approval and written informed consent from parents, 197     children scheduled for routine genitourinary operation and in whom a LMA was indicated for     anesthesia were included in the study. The size of the LMA was determined by choosing the     size that was best matched with the auricle of the children. The results were compared with     the standard method recommended by the manufacturer's weight-related guidelines. The patients     were classified in different groups depending on the PLMA sizes determined by both methods. A     kappa coefficient evaluated the agreement between both techniques.   "
78574|NCT02257398|"     This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind crossover,     single-dose study to evaluate the effects of a therapeutic (1000 milligram [mg]) and     supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400 mg)     and placebo on the corrected QT interval (QTc) as assessed by continuous 12-lead Holter     electrocardiograms (ECGs) in approximately 55 healthy volunteers.      All subjects will receive single doses of GSK2140944 1000 mg, GSK2140944 1800 mg,     moxifloxacin 400 mg, and placebo in a randomized sequence. A double-dummy approach will be     used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo and     GSK2140944 or placebo will be administered.      Subjects will be screened within 30 days prior to entry to the clinic. Subjects will report     to the clinical unit on Day -2 of Period 1 and on Day -1 in subsequent periods. Subjects will     remain confined until check out procedures have been completed on Day 3 (5 days confinement     in Period 1 and 4 days in the following 3 periods). There will be a washout of at least 7     days between doses. The follow-up visit will occur 7-10 days after the final dose. Total     duration of the study (from screening to the follow-up visit) will be approximately 60 days.   "
78575|NCT02257385|"     This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to     evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once     daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol     plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a     treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive     Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered     via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is     non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus     tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume     in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility     criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to     randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week     12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study     participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK     group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH     & Co. KG. BREEZHALER is a registered trademark of Novartis AG.   "
78576|NCT02257372|"     This is a multicenter, randomized, double-blind, parallel-group study to evaluate the     efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered     once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist     (ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a     treatment period of 12 weeks in subjects with COPD. This study is designed to investigate the     addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the treatment     of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone Propionate/Salmeterol     Combination (FSC) 500/50 twice daily generic products such as AIRFLUSAL FORSPIRO inhaler     500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg twice daily and SYMBICORT     TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12 mcg twice daily, over 12     weeks in subjects with COPD. Albuterol/salbutamol metered-dose-inhaler (MDI) or nebules will     be issued throughout the study for use as-needed (prn).      Subjects who meet the eligibility criteria will be randomly assigned to one of the following     blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and     Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be     randomized in order to complete at least 206 evaluable subjects. The total duration of the     study will be approximately 14 weeks for each subject.      UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a     monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of     COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment     of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United     States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under     regulatory review in other countries.      SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies. Other     company or product names mentioned herein may be the property of their respective owners.   "
78605|NCT02256982|"     This research study is evaluating the use of radiation therapy in combination with     chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of     gastrointestinal cancer.   "
78688|NCT02255890|"     The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as     well as the change in functional outcomes (e.g. incontinence or erectile function) from     baseline. Secondary objectives are to establish which indications lead to treatment with IRE     Nanoknife® setting and safety assessment measured by number of complications and adverse     events.   "
78577|NCT02257359|"     Epelsiban is a potent and selective oxytocin receptor antagonist in development for enhanced     implantation rates during in-vitro fertilization (IVF). This study a non-randomized, open     label study designed to assess the safety, tolerability and pharmacokinetics of additional     repeat doses of epelsiban in healthy females, and will be the first dosing experience of     greater than 200 milligram (mg) as a single dose with this compound. Data from this study     will inform the selection of doses of epelsiban to be used in future clinical studies. This     study will be composed of 3 periods: Screening, Treatment, and Follow-up. The total duration     that a subject involved in the study will be up to 6 weeks. At least 2 cohorts of subjects     will be enrolled in this study and cohorts will be conducted sequentially. Additional cohorts     will be enrolled if determined necessary. A sufficient number of subjects will be screened     for the study to obtain approximately 6 evaluable subjects per cohort.   "
78578|NCT02257346|"     When given intravenously, the local anesthetic lidocaine has been shown to decrease the     amount of pain medication patients require when recovering from several types of surgeries.     Cesarean delivery is a very common surgery in the United States, effecting more than 1     million women each year. The investigators hypothesize that lidocaine, given during and     immediately after a patient undergoes a cesarean section, will help improve a mother's     overall recovery experience, as well as positively influence bonding with her new baby.   "
78591|NCT02257177|"     This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre,     placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety,     tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2     will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion     cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male     subjects and female subjects of non child-bearing potential with IPF.   "
78625|NCT02256722|"     Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg     ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol     and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose     of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol   "
78579|NCT02257333|"     The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic     retinopathy, and is a common cause of unilateral visual loss. The risk factors that     predispose to RVO are many and are generally the same as those found in vascular alterations     involving other parts of the body, as in the case of stroke or coronary heart disease.     Several authors have attempted to determine whether the pathogenesis of RVO can be of     arterial type, considering the disease as consequent to atherosclerosis, rather than     resulting from venous disease. Although less frequent than the other diseases RVO affects     considerably on health care costs. Direct medical costs showed that in one year a patient     with this disease has a higher than average cost for a patient with hypertension or glaucoma.     Knowing the prevalence of the disease in Italy and identify modifiable risk factors,     recognizing additional risk factors related to gender, genetic predisposition and especially     the social-economic and cultural background in the pathogenesis of RVO, are the objectives     that led to the planning of this study. In order to assess the prevalence of the disease and     the current clinical practice we aim to create an online register between Italian     specialist centers (ophthalmic emergency care and thrombosis centers) with immediate     portability and usability of the data.   "
78580|NCT02257320|"     The study is an open-label, prospective, single-center, non-randomized feasibility study of     the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the     impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events     and incidence of migraines and headache in subjects diagnosed with sleep bruxism.   "
78581|NCT02257307|"     Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a     multi-center observational study will focus on feasibility, and relative cost-effectiveness     of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of     at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical     Center.   "
78582|NCT02257294|"     The purpose of this study is to determine the safety and efficacy of reduced doses (10 mg and     20 mg) of intra-coronary alteplase compared with placebo as an adjunct to PCI in reducing MVO     and its consequences in high risk patients with STEMI.   "
78583|NCT02257281|"     The purposes of study are to investigate the effect of therapeutic ultrasound for the     inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on     different inflammatory level.   "
78584|NCT02257268|"     The main purpose of this study is to evaluate the effectiveness of VAMOS program, a physical     activity and healthy eating promotion program, in hypertensive from Recife-Pernambuco-     Brazil. Approximately 90 subjects with a diagnosis of hypertension, under anti-hypertensive     medication and classified as non-physically active, will be selected and randomly distributed     into two groups: a change behavior group (CBG) and control group (CG). The CBG will     participate of a change behavior program, entitled VAMOS - Active Life Improving Health, for     12 weeks and composed of a weekly meeting, in group, lasting about 90 minutes. In each weekly     meeting, will be presented and discussed guidelines and strategies for practical physical     activities in different fields and for adoption of a healthy diet in order that the level of     physical activity and eating quality improve. The program will be evaluated by effectiveness,     implementation and maintenance (initial and individual level) dimensions of RE-AIM framework.     The effectiveness will be assessed from anthropometric measurements, body composition, eating     habits, physical activity level, stages of self-change, self-efficacy, social support,     quality of life and assessment of cardiovascular function at rest (clinic and home blood     pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart     rate variability) before and after 12 weeks of intervention. The implementation will be     assessed by identifying the extent to which the program will be conducted as planned. The     maintenance, initial and at individual level, will be estimated from revaluations of all     outcomes, as measured before and after the intervention, three months after the end of the     program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed     models wil be applied for for within and between groups comparison, if the premises of this     test are met. The level of significance that will be adopted is P<0.05. All analyzes will be     done at SPSS statistical package, version 17.0.   "
78606|NCT02256969|"     In this research study, the investigators are looking at the effects of Meibomian Gland     Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already     tried traditional management with no success in resolving their clinical signs (as seen by     their ophthalmologist) or their symptoms.      The investigators are also evaluating the effects of using two (2) post-procedural medication     treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP     procedure has an effect on its outcome.   "
78585|NCT02257255|"     Cesarean section is the most performed abdominal surgery in women, worldwide. The World     Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery.     However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in     hospitals and private clinics.      The most used technique of cesarean section is the known as Pfannenstiel or Classical     technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive     technique.      Several studies have show that the minimally invasive technique is faster and promotes lower     costs and less intraoperative bleeding. There is no current evidence that this technique is     less painful.      This study aims to compare the postoperative pain in both techniques,by means of two pain     scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the     McGill Scale.   "
78586|NCT02257242|"     This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the     standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell     lymphoma. This is a dose-escalation study.   "
78587|NCT02257229|"     All patients who meet inclusion criteria and who agree to participate in the study will be     evaluated for classification of clubfoot reducibility (Dimeglio 1995), which characterizes     the four components of clubfoot deformity including equinus, heel varus, calcaneopedal     rotation, and forefoot adduction.      Patients will be allowed to select treatment with either the daily massage and taping     technique or the Ponseti casting technique. It is not practical or feasible to randomize     patients as transportation and scheduling, as well as family preference and willingness to     participate, are primary factors in the French physical therapy method of massage/taping.      Once treatment intervention has been determined, patients will be enrolled into the surgical     or one of two non surgical arms (French physical therapy or Ponseti casting) of the study.     Research participation entails the retrospective and prospective review of data collected     through standard medical care.      All patients who undergo clubfoot treatment, may have the following evaluations:      Standard-of-care        -  Clinical exams- will be conducted at the initial visit, 4 weeks, 8 weeks, 12 to 14          weeks, 6 months, and 9 months following treatment. Also at 1 year, 18 months, 2 years, 3          years, 4 years, 5 years, and 10 years of age and at skeletal maturity.        -  Radiographs- standing AP and laterals of both feet may be taken at 18 months, 4 years of          age, and at skeletal maturity (for a total of 12 possible radiographs over the span of          the study).      Investigational        -  Questionnaires - at age 4, age 10, and at skeletal maturity: patient/parent baseline          assessment.        -  Radiographs- standing AP and laterals of both feet (for a total of 4 radiographs) will          be taken for all adult participants.        -  Movement Science Lab- at 2, 5, 10 years of age and at skeletal maturity. This testing          may include walking with reflective markers and electrodes attached with tape to his/her          legs, walking across a pressure plate, video, digital pictures, wearing a step monitor,          strength testing, and an agility test.        -  Physical therapy - at 4 years of age: developmental motor scale; at 10 years of age and          at skeletal maturity: motor proficiency assessment.        -  Brace compliance - patients will have a temperature logger placed in the shoes of the          Dennis-Browne Bar at the initial fitting visit in the Orthotics department. At every          subsequent clinic follow-up visit the Orthotist downloads the time/temperature data onto          a laptop from the sensor reader (A piece of computer hardware which the sensor clips          into and is attached to the laptop via the USB port). The Orthotist will then reset the          temperature logger discs in order to monitor the next period of brace wear.      The following additional evaluations may be conducted on the patients who also have surgical     treatment of clubfoot:      Standard-of-care • Clinical exams and radiographs will be conducted as is required by the     surgeon. No additional radiographs are needed for investigational purposes.      Investigational      • Movement Science Lab testing may be done before surgery, 1, 2,5, and 10 years following     surgery, and at skeletal maturity.      In addition, relevant retrospective data from your child's medical chart including clinical     history, radiographs, and data collected in the Movement Science lab, may be used.   "
78588|NCT02257216|"     The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.   "
78589|NCT02257203|"     This is a pilot randomized clinical trial of a brief educational intervention offered in     primary care for Latino parents that promotes healthy beverage consumption by infants and     toddlers. The control group will receive an educational intervention that promotes parents     reading to children.   "
78590|NCT02257190|"     A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and     time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The     reason IW is superior is unknown.      This study will look into whether it is the larger peak intensity during IW or if it is the     alternating exercise pattern that is responsible for the larger improvements seen.      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled     study, where each subject will undergo three trials. Trials will be identical except the     following interventions:        1. One hour of rest (Con)        2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of          slow walking; IW3)        3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1          min of slow walking; IW1).      After the interventions subjects will undergo a standardized mixed meal tolerance test, with     consecutive measurements of blood glucose, insulin and c-peptide.   "
78610|NCT02256917|"     The rationale of this study is to further fine-tune and individualize prophylactic treatment     of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above     1% between doses. Because trough FVIII levels are likely to be important predictors of the     efficacy of prophylaxis, the focus of this study is on PK data.   "
78592|NCT02257164|"     Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery.     The post-operative pain of this surgery is managed according to recommendation. In the     majority of case, femoral nerve block is performed. The femoral nerve block can cause     paralysis of the quadriceps more or less complete that no allowing a good quadriceps     locking. This locking is indispensable to avoid post-operative flexima and to ensure     stabilization of the knee during walking.      In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most     cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain     requires powerful analgesics with their adverse events.      Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in     the same time optimal analgesia and optimal quadriceps locking. The main objective of the     investigators study is to compare two analgesia techniques : femoral nerve block vs intra     articular injection and obturator nerve block in surgery of the anterior cruciate ligament of     the knee   "
78593|NCT02257151|"     The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement     of BMS-986142 in healthy subjects.   "
78594|NCT02257138|"     This clinical research study is made up of 2 parts: Phase 1 and Phase 2.      The goal of Phase 1 of this study is to find the highest tolerable dose of the combination of     decitabine and ruxolitinib that can be given to patients with AML.      The goal of Phase 2 of this study is to learn if decitabine and ruxolitinib can help to     control a certain kind of AML called post myeloproliferative neoplasm AML (post MPN-AML).      The safety of the drug combination will be studied in both phases.   "
78595|NCT02257125|"     This study investigates the use of motivating/rewarding features in a computer based arm     rehabilitation program. Half of the subjects will take part, besides receiving standard     therapy, in a computer based program delivering a game like scenario with visual effects and     monetary rewards in case of successful level completion, while the other half will take part     in a similar program without visual effects or the possibility to earn money.   "
78596|NCT02257112|"     Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation     during an acute testing procedure.   "
78597|NCT02257099|"     The primary hypothesis is that measures of patellofemoral alignment obtained from the     investigational cone beam CT scanner will be reduced, but still correlated to those obtained     from the conventional CT scan.   "
78598|NCT02257073|"     To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid     arthritis   "
78599|NCT02257060|"     The Linear II study is a prospective, single center, non-randomized, interventional     feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear     Type Ablation Catheter and the performance of the product when used for the treatment of     symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.   "
78600|NCT02257047|"     To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with     rheumatoid arthritis   "
78601|NCT02257034|"     To evaluate the effect of Tai chi on Fibromyalgia   "
78602|NCT02257021|"     To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of     tipranavir/r on BILR 355 BS pharmacokinetics   "
78603|NCT02257008|"     Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of     BILR 355 BS dissolved in PEG 400   "
78689|NCT02255877|"     Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel     staple placement when utilized for surgical wound closure after bi lateral unicompartmental     or bi later total knee replacement.   "
78607|NCT02256956|"     Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain     medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies     cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic     variants result in 4 major classes characterizing enzymatic activity: poor metabolizers,     intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not     known to which extent metabolizer classes determine pain outcomes or side-effects. As only     one in three pain patients is considered to be a responder to amitriptyline's co-analgesic     effect, prediction of treatment efficacy with a fast and easy to perform bedside test may     contribute to the patients quality of life. The aim of this study is to determine the     influence of cytochrome variants on experimental pain, drug related side-effects and finally     identification of active metabolites.   "
78608|NCT02256943|"     Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain     medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies     cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic     variants result in 4 major classes characterizing enzymatic activity: poor metabolizers,     intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not     known to which extent metabolizer classes determine pain outcomes or side-effects. As only     one in three pain patients is considered to be a responder to amitriptyline's co-analgesic     effect, prediction of treatment efficacy with a fast and easy to perform bedside test may     contribute to the patients quality of life. The aim of this study is to determine the     influence of cytochrome variants on experimental pain, drug related side-effects and finally     identification of active metabolites.   "
78609|NCT02256930|"     This is a single center, randomized, controlled, within subject comparison, multiple dose     study to determine the sensitization potential of M518101 on normal skin under occlusive     patch condition.   "
78611|NCT02256904|"     Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial     components perpendicular to their mechanical axis. Therefore, current surgical technique does     not replicate natural knee anatomy and biomechanics. An alternative alignment method that     attempts to replicate the kinematics of the knee is  kinematic alignment . The principle     behind kinematic alignment is placement of the TKA components so that the orthogonal 3-D     orientation of the 3 axes that describe normal knee kinematics is restored to that of the     prearthritic knee. Theoretical benefits of kinematic alignment include less ligamentous     release to balance the knee intra-operatively, more rapid recovery, better range of motion     (ROM), less post-operative pain, better knee biomechanics, and improved patient satisfaction.     However, a major concern is that there are no mid- or long-term data on implant survivorship     (absence of loosening) in TKA based on anatomical implantation. The investigators propose     to compare the clinical results of TKA implanted with mechanical alignment (standard     practice) to kinematic alignment, in a double-blind, randomized trial.   "
78612|NCT02256891|"     This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of     patients treated with arthroscopic rotator cuff repair using one of two techniques. One     technique used is the standard double row repairs utilizing medial and laterally based anchor     fixation and the other technique is the standard double row repairs utilizing medial and     laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is     hypothesized that patients undergoing the surgery with the PRFM will report a higher quality     of life than the patients that do not receive this treatment.   "
78613|NCT02256878|"     The objective of the study was evaluate that there is no clinically relevant interaction     between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite     BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in     an estimated high therapeutic dose. Pharmacokinetics (PK) of amitriptyline and nortriptyline     were measured before dosing of BIRT 2584 XX, after the first dose of BIRT 2584 XX, and after     repeated doses of BIRT 2584 XX near steady state   "
78614|NCT02256865|"     The purpose of this study is to study the effects of sleep restriction on the production of     two hormones, cortisol and testosterone. The investigators aim to show that changing these     hormones leads to insulin resistance, which is an important cause of type 2 diabetes     mellitus. The investigators may also study the effect of sleep restriction on your food     intake and cravings, mood, inflammation, metabolism (including bone), and other hormones.     Inflammation is your body's response to stress and injury. Bone metabolism is a process of     how your body regenerates (renews) new bone cells and removes old bone cells. Hormones are     natural substances (materials) that are produced in the body and that influences (effects)     the way the body grows or develops.   "
78615|NCT02256852|"     The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism     of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive     or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.   "
78616|NCT02256839|"     To compare the results of the investigational test to the currently approved QuantiFERON-TB     Gold In-Tube test.   "
78617|NCT02256826|"     To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR     355 BS   "
78618|NCT02256813|"     The study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on the     Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes.      The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral     omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6), oral caffeine (for CYP1A2) and     intravenous midazolam (for hepatic CYP3A)   "
78634|NCT02256605|"     The purpose of this prospecitve randomized controlled trial is to compare effectiveness and     patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with     Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or     deficient. The primary aim of this pilot study is to evaluate the effectiveness of once     weekly verses daily D-3 dosing regimens based on the most current IBD supplementation     guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference     in adherence between dosing regimns.   "
78718|NCT02255487|"     This is a Phase IV study designed to evaluate rate of Surgical Site Infections (SSIs) when     the IrriSept device is used in an open abdominal laparotomy for abdominal trauma or acute     surgical abdomen. Half of the eligible subjects will be randomized to receive the IrriSept     device and half of the subjects will receive the respective institution's Standard of Care     (SoC).   "
78619|NCT02256800|"     Metastatic diseases were found in 20-25% of patients with initial diagnosis of colorectal     cancer and developed in up to 50% of patients. Owing to limited post-treatment response of     5-fluorouracil (5-FU) combined with leucovorin (LV) obtained in mCRC (metastatic colorectal     cancer) patients, other therapeutic agents with different mechanisms were considered, such as     irinotecan, a potent inhibitor of topoisomerase I, which is involved in the unwinding of DNA     during replication. Bevacizumab is a humanized monoclonal antibody that inhibits tumor     angiogenesis by blocking vascular endothelial growth factor (VEGF) and was the first     antiangiogenic agent approved for the treatment of cancer.      Infusional fluorouracil/leucovorin plus irinotecan-based regimen (FOLFIRI) with bevacizumab     has been widely used as first-line treatment for patients with metastatic colorectal cancer     (mCRC). Recently, the investigators have shown that prospective analysis of uridine     diphosphate glucuronosyl transferase 1A1 (UGT1A1) genotyping for irinotecan dose escalation     (FOLFIRI regimen) with combination of bevacizumab biweekly as the first-line setting in mCRC     patients (ASCO Abstract #491 - 2013 Gastrointestinal Cancers Symposium).      In this study, the investigators will enroll approximately 320 mCRC patients (It was     considered that an increase of response rate of 15% compared to conventional irinotecan dose     of 180 mg/m2, and these were chosen as parameters with which to calculate the study power.     Initial power calculation was suggested that a minimum of 140 patients in each group would be     required to achieve statistical significance with a power of 80% at the 5% significance     level. It is estimated that about 10% of 320 mCRC patients fail to complete the study). For     these enrolled patients, the investigators will randomize and divide these patients into two     groups: control group and study group. Control group includes mCRC patients who will receive     the conventional regimen of FOLFIRI plus bevacizumab. Otherwise, patients in the study group     will have genotyping of UGT1A1 before therapy, and dose escalating of irinotecan will depend     on results of genotyping.   "
78620|NCT02256787|"     The objective of the current study was to investigate the safety, tolerability, and     pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5     mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a     high-fat breakfast was to be be investigated   "
78621|NCT02256774|"     Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of     Combivir® on BILR 355 BS pharmacokinetics.   "
78622|NCT02256761|"     The study comprised two parts. The objective of the first study period was to assess the     safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without     food in male healthy volunteers and to determine the relative bioavailability of the BIRT     2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG     400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the     safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BIRT     2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12 days,     or 750 mg qd for 28 days) in healthy male subjects (part 2)   "
78623|NCT02256748|"     The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite     BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated     high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for     CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose     of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days   "
78628|NCT02256683|"     The primary objective of this study is to assess whether Dabigatran leads to a faster     complete left atrial appendage (LAA) thrombus resolution as compared to Phenprocoumon. The     secondary objectives of this trial are to assess the impact of Dabigatran versus     Phenprocoumon on complete LAA thrombus resolution rate until week 6 and change in LAA     thrombus volume under treatment as well as to assess and compare safety and tolerability of     both drugs. A total of 110 patients with atrial fibrillation and LAA thrombus will be     randomized to receive either Dabigatran (150 mg bid) or Phenprocoumon (INR 2-3) for a least     three weeks. Thrombus resolution will be determined by transoesophageal echocardiography     (TEE) 3 weeks after start of study treatment and subsequently at week 4 and 6 if necessary,     i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the     resolution of the LAA thrombus. For those patients whose thrombus still exists after 6 weeks     treatment, the study is also terminated. Further treatments will be decided at the discretion     of the treating physician.   "
78629|NCT02256670|"     Pilot study to assess feasibility and patient acceptance of a text message cell phone     application for patients with stage I-III, hormone receptor positive breast cancer who start     adjuvant endocrine therapy.   "
78630|NCT02256657|"     The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of     using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement     toolkit includes standardized admission and discharge sets, clinical pathways and an audit     and feedback program.   "
78631|NCT02256644|"     Posttraumatic Stress Disorder (PTSD), as a common and serious mental health condition,     affects about 25% of all military personnel that have served in combat. People suffering from     PTSD may experience traumatic flashbacks, trouble sleeping, and problems in their     relationships. This study is intended to help identify genes that influence and increase the     risk of PTSD, to improve ways of detecting and treating the condition in the future.      Previous research has studied genes that increase the risk of PTSD, but none of these have     included a Veteran-only population. The current study focuses on US Veterans, utilizing the     VA Million Veteran Program (MVP) database of approximately 300,000 participants as of August     2014. In this context, participants with PTSD are referred to as cases and Veterans without     PTSD are referred to as controls.      This project will be done in three stages. The first stage will look at MVP-obtained data and     electronic health record (EHR) data to implement methods for identifying combat-exposed case     patients with PTSD and combat-exposed control patients without PTSD. The second stage will     assemble and validate a study population of 20,000 participants including 10,000     combat-exposed Veterans with PTSD as cases and 10,000 combat-exposed Veterans without PTSD as     controls. The third stage will conduct genetic analyses (genotyping) comparing the cases to     controls, to identify genes associated with increased risk of developing the condition.   "
78632|NCT02256631|"     The purpose of this study is to assess the safety and pharmacokinetics (PK) of two monoclonal     antibodies, VRC01 and VRC01LS, in HIV-exposed infants who are at increased risk of     mother-to-child HIV transmission.   "
78633|NCT02256618|"     This is a pilot study to test feasibility and safety of intravenous infusion of autologous     umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs     of encephalopathy.   "
78690|NCT02255864|"     The purpose of this study is to evaluate the safety and performance of a new coronary artery     stent for treating blockages in the arteries supplying blood to the heart muscle. The     Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the     treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over     time, leaving no permanent implant after the blood vessel has healed.   "
78635|NCT02256592|"     Even in individuals treated for HIV, chronic immune activation persists and is associated     with increased cardiovascular disease, liver disease, and mortality. HIV-infected individuals     have imbalances in the community of intestinal microbes which is thought to contribute to     increased and persistent inflammation. The purpose of this study is to examine the safety and     durability of fecal microbiota transplant (FMT), the transfer of the bacterial community in     stool from a healthy donor, in HIV+ individuals on anti-retroviral therapy. The study will     also measure the effects of FMT on immune activation and inflammatory biomarkers in     anti-retroviral treated HIV+ individuals.   "
78636|NCT02256579|"     This study is to investigate clinical utility of beta2 microglobulin as an early marker for     renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.   "
78637|NCT02256566|"     The purpose of this study is to investigate the effects of a computerized cognitive training     program (an attention and memory exercise performed on a computer) on thinking and memory in     individuals with mood and anxiety disorders, and to begin to test whether this training     affects symptoms of depression or anxiety.   "
78638|NCT02256553|"     The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed     [Ambrosia artemisiifolia] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243     (Timothy grass [Phleum pratense] extract, SCH 697243, GRASTEK®) sublingual tablets     co-administered in participants 18 through 65 years of age with both ragweed- and grass     polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma.     The primary endpoint is the percentage of participants who experience at least one event of     local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.   "
78650|NCT02256397|"     The purpose of this study is to assess whether comprehensive care enhanced with new     technology to optimize asthma care in the home (using both a special sensor to track inhaler     use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st     second [FEV1]) is effective in reducing total days when medical treatment is given outside     the home (in clinic, emergency department, or hospital) among children with severe asthma     receiving comprehensive care.   "
78651|NCT02256384|"     The study will evaluate the performance of measuring respiration rate with the Respiratory     Acoustic Monitoring (RAM).   "
78652|NCT02256371|"     A randomized double-blind controlled two centers study. The primary objective of this study     will be to show a superiority of hypnosis over relaxation on pain intensity in patients with     neuropathic pain.   "
78653|NCT02256358|"     Compare the effects of intravenous midazolam and ketamine on emergence agitation after     sevoflurane anesthesia   "
78639|NCT02256540|"     This pilot study plans to learn more about the aging of blood vessels and arteries in women.     As women age and go through menopause, their risk for cardiovascular disease increases. Also     with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone     replacement therapy to restore estradiol levels does not protect women from cardiovascular     disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease     risk. However, there are differences between men and women in their response to exercise. In     older men, exercise improves the health of their arteries, but in postmenopausal women,     exercise does not provide this benefit. The purpose of this pilot study is to determine     whether low estradiol levels in postmenopausal women are responsible for the poor vascular     response to exercise. In this study the investigators will also test whether treatment with     resveratrol, a plant compound found in red wine, improves postmenopausal women's response to     exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol     will improve vascular responses to an acute bout of exercise.   "
78640|NCT02256527|"     Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital     and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving     Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in     which patients received either the Taxus Liberte or XIENCE V drug eluting stent.   "
78641|NCT02256514|"     The purpose of this study is to evaluate daily dosing of oral immunotherapy     hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical     intervention or with recurrent tumor after surgery.   "
78642|NCT02256501|"     According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in     pediatric, new modality of treatment is emerging. There are some case reports of     administration of stem cell therapy. The investigators design the first randomized clinical     trial in this setting. The investigators enroll 32 pediatric IDCM patients in two groups (16     pts. in each group including cell therapy and control). The investigators assess the safety     and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear     cells in this patients compared to control group.   "
78643|NCT02256488|"     The purpose of this study is to evaluate the immunologic equivalence of three consecutive     lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess     immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit     influenza vaccine (TIVf).      The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.     Female subjects of childbearing potential were tested for pregnancy before the administration     of the vaccine and included only if using and agreeing to continue to use contraception     during the course of the study.      The total study participation time per subject is about 3 weeks.   "
78644|NCT02256475|"     This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and     pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome     (TS). The study will be conducted in approximately 18 male and female children (6 to 11 years     of age) and approximately 18 male and female adolescents (12 to 18 years of age). Both age     groups will be divided equally into 3 dosing cohorts with 6 subjects each. Ascending doses     will be evaluated as part of a staggered-cohort design. Study drug will be administered in     each cohort for 14 consecutive days.   "
78660|NCT02256267|"     The aim of this two-period study is to compare how much of the study drug gets into the blood     stream when it is given as a single oral dose and when it is given as a single oral dose in     combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is     used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other     infections). Each participant will complete both study periods.      The study will last about 34 days. Screening is required within 28 days before study drug is     given.   "
78645|NCT02256462|"     Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in     children with Crohn's disease. Design: A prospective, randomized, open label study. Setting:     Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who are     diagnosed with CD and are planned to receive adalimumab treatment. Main outcome measures:     Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures:     Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The effect of     routine adalimumab drug monitoring-based treatment on trough levels and anti-adalimumab     antibodies during therapy.   "
78646|NCT02256449|"     A multicentre, observational, prospective device registry, with no control group, designed to     evaluate the efficacy and safety of the bioresorbable coronary device, used according to the     indications of use, in daily clinical practice in a consecutive number of patients undergoing     PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included     in the registry.   "
78647|NCT02256436|"     Participants with metastatic or locally advanced/unresectable urothelial cancer that has     recurred or progressed following platinum-based chemotherapy will be randomly assigned to     receive pembrolizumab or Investigator's choice of paclitaxel, docetaxel, or vinflunine. The     primary study hypotheses are that pembrolizumab will prolong Overall Survival (OS) and     Progression-free Survival (PFS) compared to paclitaxel, docetaxel, or vinflunine.      Effective with Amendment 15, eligible participants who were allocated to the Active     Comparator arm and experienced disease progression will be provided with the opportunity to     crossover to receive pembrolizumab 200 mg one time every three weeks (Q3W) for up to two     years of treatment in the Crossover Phase of the study.   "
78648|NCT02256423|"     This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to     determine the comparative pharmacokinetic profile of the Test Investigational Medicinal     Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the     reference products Nurofen® 200 mg tablet and ibuprofen 200 mg soft gel capsule following     single dose administration in healthy male and female subjects.      The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3     Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose).     Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1)     until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning of     Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h     post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified     times throughout the study. There is at least 48 h between dose administrations.   "
78649|NCT02256410|"     Purpose of study is to test in a randomized controlled trial (RCT) the effects of the     Nervomatrix device on various clinical outcomes of patients with low back pain, as well as     its mechanisms of action.   "
78843|NCT02253849|"     Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg     twice daily, depending on tolerability, and administered alone and in combination with     tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg     twice-daily)   "
78654|NCT02256345|"     This study will be performed to determine the safety, tolerability, and dose-response to     inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:        1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely          given to subjects with HFpEF.        2. Determine if there is a dose-response effect of nitrate supplementation on exercise          capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations          to exercise.   "
78655|NCT02256332|"     Effects of a plant based ingredient on blood glucose in Type II diabetes patients.   "
78656|NCT02256319|"     This clinical trial has been designed to study and compare changes in deep brain activity     (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation with     dexmedetomidine or propofol. The recording is made through a deep brain stimulation (DBS)     electrode implanted for PD management.      The investigators hypothesize that dexmedetomidine produces fewer changes as compared to     propofol, and that those changes are consistent and recognizable when compared to activity in     patients not exposed to any sedation. Typification of those changes would in the future allow     for patients to undergo this surgery comfortably while not compromising the quality of the     recording and of the final clinical outcome. The principal variable analyzed is the signal's     power in each of the frequency bands, absolute and relative. The analysis will include usual     clinical methods such as rapid Fourier transform (FFT) and window fast Fourier transform     (WFFT), wavelet analysis, Gabor, and coherence.   "
78657|NCT02256306|"     The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered     Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease   "
78658|NCT02256293|"     Individuals with diabetes often report that difficult thoughts and feelings about diabetes     interfere with making healthy choices with regards to diabetes management. The purpose of     this study is to evaluate a diabetes self-management group based on Acceptance and Commitment     Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in treating     psychological and behavioral difficulties. We are interested in whether individuals with     diabetes will like an ACT-based diabetes management group and whether they find the group     helpful.   "
78659|NCT02256280|"     At the end of anesthesia it's important to avoid residual neuromuscular block to ensure     adequate respiratory function preventing postoperative pulmonary complications. This trial     compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine)     after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is     faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic     anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is     to verify if there is a difference between sugammadex and neostigmine as regards adverse     events after extubation and in the postoperative period (until the 30th day after surgery).      Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value     during an accelerometric train-of-four stimulation.   "
78679|NCT02256007|"     This study designs and develops an evidence-based game approach that will enhance the     investigators understanding and usability of electronic tools to measure cognitive and     sensorimotor abilities in an inpatient rehabilitation stroke population.   "
78661|NCT02256254|"     The purpose of the study is to investigate if use of simvastatin is associated with the level     of oxidative stress in humans. The association is examined by comparing changes in oxidative     stress in a group treated with simvastatin with the change in a placebo group. The study is a     randomized-based, double-blinded placebo-controlled study. Each treatment group consists of     20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of     oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine.     A t-test will be performed to compare drug treatment with placebo. The results will be     published.   "
78662|NCT02256241|"     Stage 1:      Bone marrow will be collected from otherwise healthy patients undergoing orthopedic surgery -     arthroplasty for the treatment of degenerative joint disease or traumatised patients. The     bone marrow will be collected from disposable tissue that is removed during the normal     sequence of the surgery. These cells will be used for:      Establishment of the role of RING ubiquitin ligases in osteogenic progenitors proliferation     and differentiation in culture.      I. To determine the levels of RING ubiquitin ligases mRNA and protein in differentiating     human mesenchymal precursor cells: To test the correlation between levels of RING ubiquitin     ligases and degree of osteogenic differentiation, we will extract mesenchymal precursor cells     from the collected tissue and test the mRNA protein level of RING ubiquitin ligases upon     induction of differentiation. Specifically, we will compare the levels of RING ubiquitin     ligases before and after the initiation of differentiational stimulus in time dependent     manner by western blot and real time PCR analysis.      II. To test the impact of specific RING ubiquitin ligases on differentiation of human     mesenchymal precursor cells: to test the impact of RING ubiquitin ligases on the     differentiation of mesenchymal precursor cell from the collected tissue by testing the     expression of classical differentiational bone markers by flow cytometry (fibronectin, CD105)     and by Alkaline phosphatase (ALP) activity assay. For this aim we developed both a     constitutive and Dox-regulated conditional overexpression and shRNA lenti-viral systems that     enables efficient modulation of these RING ubiquitin ligases level.      III. Determine the role of RING ubiquitin ligases in proliferation and survival of human     mesenchymal precursor cells: Via inhibition or overexpression of ligases in mesenchymal     progenitor cells we will test the role of these ligases in proliferation and survival of     mesenchymal precursors by using MTT assay, Propidion-Iodid (PI) and tunnel assays in flow     cytometry analysis.      Stage 2:      Collection of connective tissue from patients with malignancies of musculoskeletal origin.     The tissue that will be used is part of the resected tumor specimens. The tissue will be used     for:      The establishment of the role/s of RING ligases in musculoskeletal cancers using cell culture     and in vivo activation. Test if the expression of selected positive candidates from stage 1     correlates with cancer development and progression in human-derived samples Independently of     our mechanistic experiment we aim to determine the relevance of these ligases to human     musculoskeletal cancers. As the first step we will screen primary tumor biopsies at the     protein level correlates with cancer grade and prognosis. Toward this aim we recently     generated a highly specific several anti-monoclonal antibodies in our laboratory as well use     comercial available antibodies .   "
78663|NCT02256228|"     Can perioperative administration of intra-peritoneal local anaesthetics further reduce     postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery     (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.   "
78714|NCT02255552|"     The main objective of this study is to provide confirmatory evidence of efficacy of     eteplirsen (AVI-4658) in Duchenne muscular dystrophy (DMD) patients that are amenable to     skipping exon 51. Additional objectives include evaluation of safety, biomarkers and the     long-term effects of eteplirsen up to 96 weeks, followed by a safety extension (not to exceed     48 weeks).      Sites are currently being initiated into the study. Initiation of approximately 39 planned     sites in the United States is expected to be completed by June 2016. The initiated sites can     be found in the Contacts and Locations section of this posting in addition to a listing of     the city and states of sites the investigators are working to initiate. This information will     be updated on a rolling basis as additional sites are initiated.   "
78664|NCT02256215|"     Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially     interfere with normal sleep, leading to significant impairment in patients' productivity and     quality of life.      The most common and potent of all treatment regimens are the dopaminergic agonist agents,     which carry serious adverse events in their prolonged use despite their augmentation. A few     basic studies have suggested a potential relationship between vitamin D and RLS. It has been     implicated that dopaminergic system dysfunction plays a role in the development of RLS, while     vitamin D has a protective effect on that system. This has been further substantiated by few     clinical observations that showed prompt improvement of RLS patients upon receiving     dopaminergic agents such as carbamazepine. Other studies have revealed low serum levels of     vitamin D in RLS patients, along with remarkable improvement after vitamin D replacement     therapy, as has been demonstrated in a recent pilot study.      This collectively points at vitamin D as a potential, more natural and safer treatment option     for those suffering from RLS. However, the role of vitamin D in RLS has not been effectively     investigated. The aim of this 12-week, triple-blinded, randomized, placebo-controlled trial     is to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the     efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions     that the results will contribute to better understanding of the disease and its management.      Methods and Materials: This 12-week, double-blinded, randomized, placebo-controlled trial is     take place over a duration of 2 years. It will be held in the city of Jeddah to assess a     sample of Saudi residents of the Western region.      It is comprised of a number of visits, with the first one consisting of a questionnaire that     is to be answered regarding RLS, physical examination, electromyography, the objective     multiple Suggested Immobilization test, and blood tests. The main purpose of the second visit     is to establish a diagnosis of RLS.      Clinic visits number 3 through 6 comprise the pre-randomizaiton phase. Their purpose is to     determine the patient's adherence to trial procedures and pharmacological treatment.      Then, patients are to visit the clinic every two weeks for the first two months, then at week     12. Patients will be assessed in regards to treatment response and adverse effects through     history and physical examination along with further blood tests.      Aim: to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the     efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions     that the results will contribute to better understanding of the disease and its management.   "
78665|NCT02256202|"     There are actually no standardized quality assurance procedures included in pain treatment     processes.      In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested     in pain therapy centres using the validated questionnaire Activity Index. The acceptance of     electronic data capturing is tested in patients and therapy teams (doctors and nurses).   "
78666|NCT02256189|"     To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at     moderate hypoglycemia in metformin-treated subjects with T2DM   "
78667|NCT02256163|"     The primary objectives of the study are        -  to assess the contribution of alteration of each known gene on non-syndromic TAA.        -  to map and identify unknown gene involved in the non-syndromic TAA.   "
78668|NCT02256150|"     To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of     standard therapy CTX through analyzing overall remission rate after treatment.   "
78680|NCT02255994|"     The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse     recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE     I.   "
78681|NCT02255981|"     The purpose is to assess the efficacy of acupuncture (Traditional Chinese Medicine) for     chronic macular diseases, and help to solve a problem for cases that have no treatment, no     response to the conventional treatment, or have no access to medical treatment.   "
78682|NCT02255968|"     The primary objective of the study is to determine the safety and tolerability of multiple     doses of orally administered EDP-788. Secondary objectives of the study are to describe the     pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally     administered drug.   "
78683|NCT02255955|"     Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on     postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a     lumbar disk surgery.   "
78669|NCT02256137|"     Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric     malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed     to destroy malignant cell lines, and normal tissue is not always spared. While early     treatment- related organ specific toxicities are not always apparent, many childhood cancer     survivors report symptoms that interfere with daily life, including exercise induced     shortness of breath, fatigue and reduced capacity to participate in physical activity. These     symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most     commonly described in older adults; it indicates persons who are highly vulnerable to adverse     health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors     have at least one severe chronic health condition 30 years from diagnosis, why childhood     cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons,     and why they have mortality rates more than eight times higher than age-and-gender matched     members of the general population.      Frailty is a valuable construct because it can be distinguished from disability and     co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability     that identify individuals most at risk for adverse health outcomes. These investigators have     recently presented data indicating that impaired fitness is present in survivors of childhood     acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because     frailty, characterized by a cluster of five measurements of physical fitness, is predictive     of chronic disease onset, frequent hospitalization, and eventually mortality in both the     elderly and in persons with chronic conditions. Using a frailty phenotype as an early     predictor of later chronic disease onset will allow identification of childhood and     adolescent cancer survivors at greatest risk for adverse health. An early indicator of those     at risk for adverse health will allow researchers to test, and clinicians to provide,     specific interventions designed to remediate functional loss, and prevent or delay onset of     chronic health conditions. The investigators goals include characterizing physical frailty     over a five year time span in a population of young adult survivors of childhood cancer, as     well as assessing the association between frailty and the increase in the number and severity     of chronic health conditions.   "
78670|NCT02256124|"     The purpose of this study is to determine whether lamotrigine can improve cognitive and     neurophysiological deficits in adolescents with Neurofibromatosis type 1.   "
78671|NCT02256111|"     This study will examine the effect of supervised exercise training on cardiopulmonary     function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation     therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to     date has examined the efficacy, tolerability, and safety of exercise training to prevent     and/or mitigate common adverse toxicities in men receiving combination androgen suppression     therapy for hormone-naïve prostate cancer.   "
78672|NCT02256098|"     The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent     clinical track record, good survival rates (98% 10 years survival in patients aged < 55     years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at     two years follow-up)(von et al., 2009).      The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is     designed to provide better range of motion and address the unstable feeling some patients     experience during everyday activities, such as stair descent and bending. To date (March     2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and     positive feedback was received regarding patient recovery, stability and motion.      The objective of this study is to accurately assess and compare migration, clinical and     radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented     ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing     Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary     objective of this study is to compare the magnitude and pattern of migration of the     prostheses (Femoral and Tibial component). The secondary objective of this study is to     compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective     of this study is to compare clinical and radiological outcome and PROMS of the prostheses     with migration data.      This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System     and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC     Sigma Knee System will be included in this study.      The study population will consist of patients with symptomatic osteoarthritis of the knee     scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The     Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of     which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other     indications. We anticipate that inclusion can be accomplished within a 1 year period and that     the total study duration is 3 years.      Main study parameters/endpoints are:        -  Migration of the prosthesis with respect to the host bone measured by means of roentgen          stereophotogrammetric analysis (RSA).        -  Patient Reported Outcome Measures by means of questionnaires.   "
78673|NCT02256085|"     This is a randomized controlled trial (RCT) on the efficacy of repetitive Transcranial     Magnetic Stimulation (rTMS) in the treatment of Depersonalization Disorder (DPD). TMS applies     a magnetic field to the brain for a brief period of time. TMS is a procedure that involves 30     minute-long daily sessions every weekday for a series of weeks. The investigators are testing     whether TMS can treat Depersonalization Disorder (DPD).   "
78900|NCT02253095|"     Randomized, double-blind, placebo controlled trial of a combined intervention of zinc,     albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian     children.   "
78674|NCT02256072|"     The goal of this study is to develop and test an advance planning tool to help seniors     understand projected health needs and plan ways to remain in their own homes when these     crises occur. In this phase of the study through partnerships with seniors, senior community     groups, area agencies on aging, and home care agencies the investigators are conducting a     two-armed (attention control and intervention) randomized controlled trial.      Individuals will be randomly assigned to one of two interventions: attention control or the     advance planning tool. The investigators attention control group will control for the     possibility that regular contact with the study team may improve outcomes in participants     randomized to the intervention website. Participants in the attention control arm will     navigate an electronic educational session via a National Institute on Aging at NIH Web site     about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15     minutes and a maximum of 45 minutes will be allotted for navigating the Web site. The Web     site is interactive and comparable to the intervention tool:     http://go4life.nia.nih.gov/get-started).      If randomized to intervention, subjects will be introduced to the advance planning tool, the     Plan Your Lifespan website, and given instructions on how to use it. Plan Your Lifespan is a     Web-based planning tool that provides information for seniors related to advanced health     planning for home services in specific content areas of: hospitalizations, falls,     Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan website     is also interactive in that it allows participants to enter their information and share it     with others to facilitate conversations and decision-making. Participants will navigate and     complete the Web-based advance planning tool and will be allotted a minimum of 15 minutes and     a maximum of 45 minutes to navigate the tool as part of the study.      All participants will be administered a pre- and post-test before and after viewing the     website they were randomized to. All participants will be followed up at one and three months     post via a brief phone call where follow-up questions will be asked of all participants.   "
78675|NCT02256059|"     Treatment of lateral fractures of the clavicle is challenging and has been controversially     discussed for a long time due to high non-union rates in non-operative treatment and high     complication rates in surgical treatment. A recently developed implant was proven to ensure a     biomechanically sufficient fixation of fractures leading to bony union and promising     functional outcome in a small collective of patients.   "
78676|NCT02256046|"     Aim of this thesis is to predict the incidence of esophageal ulcer bleeding after endoscopic     management of esophageal varices.      This study will be in the department of Tropical Medicine and Infectious Diseases, Tanta     University, in at least six months in the period from august 2014 to march 2015 or until the     target number of patients reached whichever is longer.   "
78677|NCT02256033|"     The purpose of this study is to test whether mild liver impairment affects blood levels of     istradefylline in humans. Decreased liver function could possibly increase istradefylline     levels.   "
78678|NCT02256020|"     Investigators anticipate to develop a customized WC-MAE for the improvement of insomnia and     depression in wheel-chair dependent elders, and to identify related mechanisms as biomarkers     for prediction and prevention of insomnia and depression in elders with physical disability     in long term care facilities.   "
78691|NCT02255851|"     The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the     CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve     stenosis indicated for TAVR.      Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information     and detailed procedural data will be captured and documented in a registry case report form.      All Sentinel filters will be sent for histopathology at an independent core-lab.   "
78715|NCT02255526|"     This project will compare BodyGuardian (BG) device measurements of breathing and activity     levels to the gold standard measurement techniques of gas exchange using a mouthpiece     connected to flow and gas analyzers measures for breathing and metabolic rate (indirect     calorimetry) for activity, We are hopeful these comparisons will help us improve upon the     measurements being made in the current version of the BG device.   "
78692|NCT02255838|"     Flexible bronchoscopes are typically reusable and therefore need high level disinfection to     prevent inadvertent spread of microbial pathogens from patient to patient. The process of     disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may     not be readily available for another patient. One solution to this problem was to use a     single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of     the bronchoscope.(Colt, Beamis, Harrell, & Mathur, 2000). Another way to eliminate potential     hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a     disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been     used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen &     Fredensborg, 2013; Pujol, López, & Valero, 2010; Tvede, Kristensen, & Nyhus-Andreasen, 2012).     Further advancement in the imaging and handling of this disposable flexible bronchoscope now     allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients     with pulmonary compromise. (FDA approval: 05-11-2013 date)      The aim of the study is to compare image clarity, suction capacity, and handling performance     of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the     investigators intend to perform a cost analysis.   "
78693|NCT02255825|"     To gain knowledge about how patients undergoing prenatal diagnosis for a fetal abnormality     understand and react to Whole Genome Sequencing (WGS) testing, so that the investigators can     develop more ethical and responsible approach to patient education, counseling, and return of     results for patients.   "
78694|NCT02255812|"     Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and     bitter. The receptors found on the tongue are also found in the entire gut. The correlation     of stimulation of these gut receptors and brain activity has not yet been examined. The     objectives are to investigate the effect of different taste substances on i) regional brain     activity and ii) satiation peptide release.   "
78695|NCT02255799|"     This is a four-site, randomized, parallel design, double-blind, placebo-controlled, 10-week     trial of donepezil 10 mg daily for verbal memory problems among adults with TBI in the     subacute or chronic recovery period. The study will recruit 160 persons with TBI and     functionally important memory problems during a four-year period of open recruitment.      The study aims are:        1. To evaluate the effects of treatment with donepezil on verbal memory as assessed by the          Hopkins Verbal Learning Test-Revised Total Trial 1-3;        2. To evaluate the effects of treatment with donepezil on memory-related activities as          measured by the Everyday Memory Questionnaire;        3. To evaluate the effects of donepezil on attention, processing speed, neuropsychiatric          symptoms, community participation, quality of life, and caregiver experiences.   "
78696|NCT02255786|"     The investigators will develop and pilot test an intervention called ACT for Parents which     aims to decrease stress and improve quality of life in parents of children < 15 years who     have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be     conducted to gather initial data on the treatment feasibility and acceptability, detect     treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine     the treatment design for a future clinical trial.   "
78697|NCT02255773|"     The goal of this research study is to learn more about fatigue and how it affects your     behavior as well as your willingness to learn new behaviors.   "
78698|NCT02255760|"     This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study     evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy     adult subjects 18 to 60 years of age.   "
78699|NCT02255747|"     This study is to evaluate the effect of anal dilation in infants and children with     constipation.   "
78700|NCT02255734|"     Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg)     after Intravenous Infusion in Healthy Volunteers.   "
78701|NCT02255721|"     The SHIP study is a randomized controlled trial of an intervention for preschool children     with sleep problems, in which we aim to give parents the knowledge, motivation, and skills     necessary to set goals, problem-solve, and improve their child's sleep. In collecting three     years of follow-up data, we will be able to determine the impact of the SHIP intervention on     childhood sleep problems, obesity, academic achievement, and emotional and behavioral     problems, as well as parental stress and daytime tiredness. This study has the dual potential     to expand treatment resources for young children with behavioral sleep problems and to     increase our scientific understanding of the long-term consequences of early childhood sleep     problems.   "
78702|NCT02255708|"     The present study aims to assess through surface electromyography, the effectiveness of     proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing     muscles of the scapula and the anterior tibial muscle.   "
78703|NCT02255695|"     The objective of this study was to evaluate the effects of a school-based exercise program on     posture, trunk range of motion and musculoskeletal pain in schoolchildren. This study was a     Randomized controlled trial. The hypothesis was that the exercise group would have the     postural deviations corrected, would have the trunk range of motion increased and would have     the prevalence of pain decreased, while the control group would have not. Three schools from     Brazil participated. The students that have been included (n=300) were randomly allocated to     experimental (EG) or control group (CG). The intervention for EG consisted in a program based     on stretching and strengthening exercises, applied twice a week, for eight weeks, with group     sessions of 50 minutes. CG did not perform any intervention. Qualitative and quantitative     postural evaluation (PAS/SAPO), musculoskeletal pain (self-report) and trunk mobility were     collected.   "
78704|NCT02255682|"     Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of     cardio-vascular diseases. The use of statins has increased markedly and it is now one of the     most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a daily     basis, 40 % of these are taking the medication without having any other risk factors for     cardio-vascular diseases than elevated blood-cholesterol i.e. they are in primary prevention.      Statins are not without side effects and studies have shown that there is an elevated risk of     developing diabetes when taking statins. This has led to an increased debate about the use of     statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent     one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5 years.     These data suggest that more conservative use of statins to prevent CVD in otherwise healthy     individuals at low risk for future CVD may be warranted.      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially     can prevent a physically active lifestyle. The biomedical background of these side effects is     not fully elucidated but it has been shown that there is a link to decreasing levels of an     important enzyme, Q10, which plays a role in muscle energy metabolism.      Hypothesis      The overarching research question is: why does statin treatment cause muscle pain? Does     statin treatment impair (or even prevent) physical exercise training? Furthermore we would     like to answer the following questions:        1. Does statin treatment impair (or even prohibit) physical exercise training?        2. Does statin treatment cause:             -  Decreased muscle strength?             -  Skeletal muscle inflammation?             -  Decreased mitochondrial respiratory function?        3. Abnormal glucose homeostasis?   "
78705|NCT02255669|"     The purpose of this study is to compare the duration of stent patency between partially     covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.   "
78706|NCT02255656|"     Primary Objective:      To evaluate long-term safety of alemtuzumab.      Secondary Objectives:      To evaluate long term efficacy of alemtuzumab. To evaluate the safety profile of patients who     received other Disease Modifying Treatment's (DMT) following alemtuzumab treatment.      To evaluate patient-reported Quality of Life (QoL) outcomes and health resource utilization     of patients who received alemtuzumab.      To evaluate as needed re-treatment with alemtuzumab and other DMTs.   "
78707|NCT02255643|"     Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic     pain not responsive to medication. An electrode is placed on the surface of the brain and     connected to a programmable battery in the chest.      The strength of stimulation can be individually adjusted by changing the voltage of     stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low     voltage will not provide pain control. The aim of this study is to analyze the optimal     stimulation parameters in patients already implanted with a motor cortex stimulation who have     received good pain relief. The actual voltage may vary widely between patients but the     investigators feel that there may be an ideal voltage if it is measured as a percentage of     motor threshold (PMT). If motor threshold is the stimulation voltage that can evoke a muscle     contraction then a PMT = 80% would be a voltage that was eighty percent of that value.     Although the actual voltage may be widely different between patients, the percentage needed     may be very similar. The investigators therefore plan to measure the effect of different     percentages of PMT in patients already being treated with motor cortex stimulation.      Systematic analysis of the findings of this study might help the individual participant and     future patients to better programming and less side effects.   "
78708|NCT02255630|"     Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of     medals. However, most previous research has shown that β2 agonists do not improve exercise     performance in either asthmatic or non-asthmatic athletes. Although the majority of these     studies do not show an ergogenic effect, the small number of studies with extended exercise     bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet     sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have     different effects on these two groups of athletes, the investigators will measure exercise     performance in both female and male elite cyclists. The investigators hypothesize that     athletes will perform better during a combination steady-state/sprint exercise task following     salbutamol administration.   "
78709|NCT02255617|"     The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in     cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance     therapy with lactulose and/or rifaximin or metronidazole.   "
78710|NCT02255604|"     The investigators want to investigate whether specific immunotherapy can be delivered     directly into a lymph node. The investigators think that a direct introduction of allergen to     the antigen presenting cells in the lymph node a give a strong immune response and that this     can change the number of injections needed in allergen immunotherapy. The investigators do     measurements of clinical effect and a variety of paraclinical test to see if the     investigators can find af biomarker of successful specific immune therapy of grass allergy.   "
78711|NCT02255591|"     The main objective of the trial is to complete a double-blinded randomized controlled trial     of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident     technique by estimating the time of performance of lumbar plexus blocks in healthy     volunteers.      Secondary objectives include a) estimates of number and depth of needle injections, distance     of injection site from the midline, minimal electric nerve stimulation to trigger muscular     response and the type of response, and volunteer discomfort during block injection, b)     measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory     block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the     hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e)     perineural and epidural distribution of local anesthetics added contrast visualized on     magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock     technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy     volunteers.      The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound     technique, and that the success rate of the Shamrock technique is equal to or higher than the     Lumbar Ultrasound Trident technique.   "
78712|NCT02255578|"     Women with Polycystic ovary syndrome (PCOS) experience multiple fertility treatments, a long     treatment duration and a low pregnancy prevalence. This syndrome is frequently accompanied by     overweight and insulin resistance which can mediate the limited response to fertility     treatment. The Endobarrier device was shown to be efficient in weight and glucose lowering.     The aim of this study is to investigate the ability of the Endobarrier device to improve the     outcome of fertility treatments in women with PCOS.   "
78713|NCT02255565|"     The purpose of this study is to determine whether Quillivant XR is effective in the treatment     of ADHD in children with Autism Spectrum Disorder (ASD).   "
78901|NCT02253082|"     Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for     thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated     pilot trial   "
78721|NCT02255448|"     Cardiac output (CO) is the volume of blood ejected from the heart and is a product of stroke     volume (SV) vs heart rate (HR). It is closely related to Blood Pressure (BP) by the formula     CO = Mean Arterial Pressure (MAP) / Systemic Vascular Resistance (SVR). Cardiac output     monitoring is well established and validated for guiding fluid administration and     resuscitation in intensive care and perioperatively in the non-pregnant population. Available     CO monitoring methods may risk maternal health or fetal wellbeing or are unvalidated in the     pregnant population. Invasive and semi-invasive methods of measuring CO such as the pulmonary     artery catheter, the 'gold standard' require invasive arterial or central access negating     their use in all but a select group of labouring women and have potentially serious risks     attached to their usage. Echocardiography is a well-established and validated technique     requiring no invasive access but the requirement for an experienced operator limits routine     usage. It uses an external ultrasound probe to scan the heart.      Several novel non-invasive cardiac output monitors have recently come to the market including     the estimated cardiac output esCCO monitor (Nihon Kohden) which uses Pulse Wave Transit Time     (PWTT) to estimate cardiac output. It requires 3-lead Electrocardiography and pulse oximetry     alone which is part of the routine monitoring for high risk patients on the labour ward.      The investigators research aims to evaluate the accuracy and precision of the esCCO in     pregnant women and subsequently assess its utility during medical interventions such as     epidural analgesia or caesarean section. The initial validation will take place in an     antenatal clinic where women are assessed using Doppler echocardiography. The investigators     will then compare the echocardiography results vs the esCCO results.   "
78722|NCT02255435|"     Friedreich's ataxia is an autosomal recessive cerebellar ataxia caused by triplet-repeat     expansions. The causative mutation is a trinucleotide (GAA) repeat expansion in the first     intron of the frataxin gene, leading to impaired transcription of frataxin. The pathological     consequences of frataxin deficiency include a severe disruption of iron-sulfur cluster     biosynthesis, mitochondrial iron overload coupled to cellular iron dysregulation, and an     increased sensitivity to oxidative stress.      A hallmark of Friedreich's ataxia is impairment of antioxidative defense mechanisms, which     play a major role in disease progression. Studies have demonstrated that nuclear factor     erythroid-derived 2-related factor 2 (Nrf2) signaling is grossly impaired in patients with     Friedreich's ataxia. Therefore, the ability of omaveloxolone (RTA 408) to activate Nrf2 and     induce antioxidant target genes is hypothesized to be therapeutic in patients with     Friedreich's ataxia.      This 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone     (RTA 408) in the treatment of patients with Friedreich's ataxia.      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,     dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in     patients with Friedreich's ataxia.      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,     parallel-group study to evaluate the safety and efficacy of omaveloxolone (RTA 408) 150 mg in     patients with Friedreich's ataxia. Patients enrolled in Part 2 will be randomized 1:1 to     receive omaveloxolone (RTA 408) 150 mg or placebo.      Extension: The extension will assess long-term safety and tolerability of omaveloxolone (RTA     408) in qualified patients with Friedreich's ataxia following completion of Part 1 or Part 2.     Patients will not be unblinded to study treatment in Part 1 or Part 2 upon entering the     extension study. Patients will receive open-label omaveloxolone (RTA 408) at 150 mg once     daily.   "
78723|NCT02255422|"     Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a     wide range of biochemical and genetic mitochondrial defects and variable modes of     inheritance. Currently there are no effective treatments for this disease. Despite the     heterogeneous myopathy phenotypes, a unifying feature of mitochondrial myopathies is that the     pathogenic mtDNA mutations and/or nuclear mutations of the electron transport chain     invariably lead to dysfunctional mitochondrial respiration. This reduction in mitochondrial     respiration leads to a reduced ability to produce cellular adenosine triphosphate (ATP),     often resulting in muscle weakness, exercise intolerance, and fatigue in patients with     mitochondrial myopathies.      RTA 408 is a potent activator of Nrf2 and inhibitor of NF κB (nuclear factor     kappa-light-chain-enhancer of activated B cells), and thus induces an antioxidant and     anti-inflammatory phenotype. Several lines of evidence suggest that Nrf2 activation can     increase mitochondrial respiration and biogenesis. Collectively, available data suggest that     the ability of RTA 408 to activate Nrf2 and induce its target genes could potentially improve     muscle function, oxidative phosphorylation, antioxidant capacity, and mitochondrial     biogenesis in patients with mitochondrial myopathies.      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,     dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in     patients with mitochondrial myopathies.      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,     parallel study to evaluate the safety, efficacy, and pharmacodynamics of up to 2 dose levels     of omaveloxolone (RTA 408) in patients with mitochondrial myopathies. Eligible patients in     Part 2 will be randomized 1:1:1 to receive omaveloxolone (RTA 408) (at one of 2 doses chosen     from Part 1), or placebo.   "
78724|NCT02255409|"     Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared     to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial     V118_05   "
78725|NCT02255396|"     Estradiol and Testosterone are two important hormones for the regulation of an effective     spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in     seminal plasma of men with non-obstructive azoospermia may be a predictive test before     surgical testicular biopsy to determine the chance of a positive sperm extraction to use for     ICSI.   "
78726|NCT02255383|"     The primary objective of this study is to obtain implant survivorship and clinical outcomes     data for commercially available Persona fixed bearing knee implants used in total knee     arthroplasty. The assessment will include implant survivorship and clinical performance.   "
78727|NCT02255370|"     Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of     inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible     for the anti-inflammatory effect of curcumin      Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with     thiopurines in the prevention of Crohn's disease post-operative recurrence.   "
78728|NCT02255357|"     This proposal describes a combined laboratory and clinical trial preliminary investigation to     advance medication development for cocaine dependence. The main objective is to test whether     intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the     stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal     desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be     evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self     reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response     to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence     induction hospitalization. For those patients with family and work obligations, an outpatient     abstinence induction procedure is available. The response to the desmopressin challenge will     be compared to a cohort of matched control subjects. After abstinence induction, cocaine     dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24     IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.   "
78729|NCT02255344|"     Through the National Registry of patients with ACS in the IMSS (RENASCA IMSS) the     investigators will know the real world in terms of risk factors frequency, clinical     presentation and its complications, and in the end they can build a risk model for early     Major Cardiovascular Events (MACE).   "
78730|NCT02255331|"     Patients with a total hip replacement may require early revision surgery due to an adverse     local tissue reaction or bone resorption that occurs due to wear debris released from the     implant. A non-invasive imaging biomarker does not exist to identify or to follow total hip     replacement patients who are most at risk for suffering this type of premature implant     failure. This study will evaluate magnetic resonance imaging (MRI) as a biomarker to predict     a failing hip replacement.   "
78731|NCT02255318|"     The therapeutic management of patients with cancer often requires the establishment of a     chamber implantable catheter. Infections are the main complication of these catheters. These     infections may be responsible for a significant impairment of quality of life for patients,     and may increase the frequency and duration of hospitalizations. The rate of mortality from     these infections is about 17%. The objective of this study is to evaluate the efficacy of a     1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections     related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral     nutrition.      This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in     patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline     (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive     pressure). The lock will be instilled after the end of the session IV treatment     (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary     endpoint will be the rate IRCIC in both groups.   "
78732|NCT02255305|"     The purpose of the study is to determine the safety and efficacy of Fecal Microbiota     Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI)     as compared to standard antibiotic therapy. Patients who have tested positive for CDI within     90 days of an admission for relapse of CDI will be approached to participate in this     open-label, randomized controlled trial. Patients will either be randomized to the     intervention group (receive FMT via retention enema) or the control group (receive     antimicrobials targeting CDI).   "
78733|NCT02255292|"     Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including     the cannabidiol (CBD) which does not posses the psychotropic effects of     D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects and     they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence from     clinical trials among cancer patients is needed. The aim of the current study is to evaluate     the impact of CBD as single treatment among cancer patients.   "
78734|NCT02255279|"     The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a     more immunogenic and effective response compared with conventional influenza vaccines in     elderly and adults.      The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6     to <72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted     trivalent influenza vaccine (TIV).   "
78735|NCT02255266|"     This study is conducted in Europe. The aim of this study is to investigate Long-Term     Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.   "
78736|NCT02255253|"     In this research, the investigators aim to compare the antihypertensive efficacy and safety     of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic     Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.     The research will be conducted in the rural area in Hebei province, where people have a high     sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local     county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB     or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day     respectively. After two-month treatment, the investigators will evaluate and compare the     antihypertensive efficacy and safety between the two therapies.      The first objective of the research is to compare the antihypertensive efficacy of     monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic     Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate     hypertension.The second objective is to compare the safety between the two therapies applied.      Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure     between treating high sodium intake patients with mild to moderate hypertension with     telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy     differences of lowering the systolic pressure between treating high sodium intake patients     with mild to moderate hypertension with telmisartan and hydrochlorothiazide.      This research is a multicenter randomized double-blinded parallel controlled trial targeting     on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200     subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of     telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the     compliance of the patients will be followed after a week. The investigators will evaluate the     efficacy of blood pressure control and the safety of the medicines after one month and two     months of the beginning of therapies. Figure 1 shows the research process.   "
78737|NCT02255240|"     The purpose of this study is to test an intervention that uses home console video games to     encourage increased physical activity among postmenopausal breast cancer survivors.   "
78738|NCT02255227|"     This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal     vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by     immunosuppressants and/or biotherapies. At present such patients are poorly protected by     anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is     much weaker than in the general population. There are two types of anti-pneumococcal     vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate,     Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising     immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13®     followed by one dose of PSV-23® after an interval of two months. In the case of young     children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the     PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.      Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD     patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine,     PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with     a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer     against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We     also want to evaluate the immunological impact of these different strategies in their     capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim,     we are studying all immunological functional aspects of the antibodies and B lymphocytes     induced by the two vaccine strategies.   "
78751|NCT02255058|"     It was decided to develop a comprehensive disability score specifically designed for patients     receiving prolonged mechanical ventilation (PMV); the collection of information included in     the score should not impose any further intervention beyond what is routinely performed. So a     new questionnaire was created (called the Multi-INdependency Dimensions (MIND) that included     3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. Each     question was adapted to have a 5 item Likert scale.      The primary objective of the study will be to evaluate the psychometric performance of the     MIND score in terms of validity, reliability and sensitivity to change over time. The     secondary objective will be to assess the inclusion of biological markers on the overall     performance of the MIND score   "
78739|NCT02255214|"     Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages     over a general anaesthetic however contraindications include coagulopathy. Guidelines suggest     a CNB should not be undertaken with an International Normalised Ratio (INR) of 1.5 or     greater. A common cause of an elevated INR is warfarin therapy and regular monitoring of its     effects is required.      The Hemochron Signature Elite is a portable micro coagulation system that can be used as a     point of care (POC) anticoagulation monitoring device. Marketing is focussed on its accuracy,     convenience and efficiency in delivering a coagulation result.      This study will assess the accuracy of this device in calculating the International     Normalised Ratio (INR) result. This will be compared to another INR result obtained on the     same sample via the current gold standard testing equipment in the Royal Infirmary Edinburgh     (RIE) laboratories.      The study will include patients presenting for surgery who have had their warfarin therapy     stopped within the previous 7 days. Patients on warfarin therapy requiring surgery are     currently identified in preoperative assessment clinics, on average 12 weeks prior to their     date of surgery.      Anecdotally there appears to be a difference between the 'expected' and actual INR when a POC     device is used. Concern exists that patients may be inappropriately denied the potential     benefits of central neural blockade (CNB) if a POC device provides a falsely high result, or     conversely the investigators may be proceeding with CNB in patients with an unacceptably high     INR if POC provides a falsely low result. There is also the possibility of improving hospital     efficiency using this device as it provides a result much faster than the laboratory.   "
78740|NCT02255201|"     The purpose of this study is to determine the effects of four different pre-workout beverages     as compared to placebo on muscular strength and endurance, perceived energy and cognitive     performance in healthy adult males.   "
78741|NCT02255188|"     The purpose of this study is to determine whether the Vascular prosthesis manufactured by     Electrospinning is safe with respect to the development of thrombosis.   "
78742|NCT02255175|"     Using neuroimaging, the investigator will study the effects of estrogen on mood and brain     function in perimenopausal women either with or without depression.   "
78743|NCT02255162|"     This research study is evaluating the safety and tolerability of the drug lenalidomide in     combination with and following mismatched related donor microtransplantation in high risk AML     patients in first remission. This study also aims to define the maximum tolerated dose (MTD)     of lenalidomide given in this setting.      Microtransplantation seeks to give the participant donor cells in hopes that those cells can     attack the underlying cancer. However, since the donor cells do not replace all of the host     cells, it can hopefully avoid many of the serious risks involved with standard transplant,     including graft-vs.-host disease (GVHD) - a complication where the donor cells attack the     participant's normal body. Recent studies have suggested that lenalidomide can help aid donor     cells to attack cancer when given after a stem cell transplant. This trial is trying to see     if lenalidomide can help encourage the attack of leukemia cells by donor cells given as part     of microtransplantation.      The FDA (the U.S. Food and Drug Administration) has approved lenalidomide but it has been     approved for other uses such as in the treatment of other cancers including multiple myeloma     and non-Hodgkin lymphoma. Although lenalidomide has been studied in patients with AML, it has     not been approved by the FDA for standard use in AML. Lenalidomide is a compound made by the     Celgene Corporation. It has properties which could demonstrate antitumor effects. The exact     antitumor mechanism of action of lenalidomide is unknown.   "
78744|NCT02255149|"     This study will involve placing donor bone into the back of lower jaw then covering with a     newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it     will be removed. Implants will be placed in the newly formed bone.      The goal of this study is to test how well using a newly designed titanium mesh and bone     particles can grow bone in the back of the lower jaw. The investigators are also checking if     the newly formed bone will stay around implants that will have been in use for 12 months.   "
78745|NCT02255136|"     The purpose of this study is to test whether individualized homeopathic medicines can produce     any significant effect beyond placebo in treatment of allergic rhinitis and/or induced     bronchial asthma   "
78746|NCT02255123|"     This study is a multicenter, non-randomized, retrospective study to collect long term (4     years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05     study (NCT00466804) to evaluate participant and graft survival.   "
78747|NCT02255110|"     This is a Phase 2, single-arm, Japanese multicenter trial to evaluate the safety,     tolerability, and efficacy of TH-302 in combination with doxorubicin in subjects with locally     advanced unresectable or metastatic soft tissue sarcoma (STS).   "
78748|NCT02255097|"     This is a study of single-agent pembrolizumab (MK-3475) in participants with recurrent and/or     metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on     platinum-based and cetuximab therapy. The primary study hypothesis is that pembrolizumab will     provide a clinically meaningful objective response rate (ORR).   "
78749|NCT02255084|"     Despite the existence of an effective screening test (pap smear), cervical cancer is, every     year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in     10 women are not screened or not often enough (nearly 7 millions women). It is therefore     necessary to develop new strategies to reach these women. The etiological factor of this     cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV).     Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with     HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal     self-sampling with HPV test is a powerful means to increase the participation rate in     cervical cancer screening.   "
78750|NCT02255071|"     In recent years, there is an increasing trend in the number of patients with Gastroesophageal     reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive     reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan     (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen.     Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6     point) acupressure in patients with GERD.   "
78839|NCT02253901|"     Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and TRUVADA     on BILR 355   "
82935|NCT02200445|"     The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of     Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.   "
78752|NCT02255045|"     The investigators propose that the sustained vaginal administration would have a better     response with respect to pain, and a better safety profile than the oral administration of a     non-steroidal anti-inflammatory drug.      Assess the relief of the symptoms associated to dysmenorrhea a specific survey was elaborated     that also included a Visual Analog Scale (VAS) to make objective and measure dysmenorrhea as     is the case with McGill's Pain Questionnaire (MPQ).   "
78753|NCT02255032|"     The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA,     in subjects with macular edema following non-infectious uveitis. A single suprachoroidal     injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema     following non-infectious uveitis.   "
78754|NCT02255019|"     The aim of this study is to find an optimal magnetic resonance imaging (MRI) method to     examine patients with inflammatory bowel disease (IBD). Patients should furthermore avoid     being exposed to unnecessary X-rays and invasive examination.      It is the investigators expectation that this study will benefit to future patients, as they     will be offered MRI as the first choice. Hereby, the patients avoid the risks and discomfort     associated with x-ray examinations. The aim is that patients with IBD achieve better and     earlier treatment and if this is achieved it both benefits patient and public health. An     earlier treatment leads to fewer hospitalizations and thereby saving the community money.      The investigators hope is that the investigators study will show that MRI is one of the best     tool to examine patients with IBD and that this in future leads MRI to be the first choice in     contrary to all examinations with x-ray exposer, unless there is any contraindication to MRI.   "
78755|NCT02255006|"     Some studies suggest that acupuncture improve flow mediated dilation (FMD) that represents     endothelial function, but no study has investigated whether acupuncture protects against     ischemia and reperfusion (IR)-induced endothelial dysfunction in humans.      This is a prospective crossover study clinical trial. In the first crossover study, 20     healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture     or control. Endothelium-dependent, FMD of the brachial artery will be measured before and     after IR (15 minutes of ischemia at the level of the proximal upper arm followed by 15     minutes of reperfusion). Acupuncture will be performed from 10 minute after ischemia till the     end time of reperfusion for 20 minutes. In the second single arm study, 16 volunteers are     administered oral 5mg glibenclamide two hours before IR injury (n=8) or selective cox-2     inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for     acupuncture effect on IR injury. FMD measurements and acupuncture intervention during IR     injury are same as above mentioned.   "
78756|NCT02254993|"     Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in     healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for     safety and microbiology parameters. A subset of subjects will be assessed for pharmacokinetic     parameters. No longer enrolling study subjects in Part A.      Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and     female subjects 18-75 years of age. All subjects will be assessed for safety,     pharmacokinetic, and microbiology parameters.   "
78757|NCT02254980|"     In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have     superior wear resistance and improved mechanical properties as compared to that of standard     highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE     although several trials are ongoing. All of these trials use uncemented acetabular cups     intended for biological fixation. In many countries the standard fixation method for the     acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a     lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation     when used in acetabular components. The aim of the study is to compare migration, linear wear     and clinical results between two types of cemented acetabular cups.   "
78758|NCT02254967|"     The main objective of the study is to evaluate whether the extended duration fidaxomicin     therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at     30 days after end of treatment (Day 40 or Day 55).   "
78759|NCT02254954|"     This is a prospective, single-center, open-label, 3+3 dose escalation Phase 1 safety study.     Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the     standard of care treatment for GBM. The study consists of a screening period, a treatment     period, and a 30-day safety follow up period. The treatment period includes 6 weeks of     concurrent therapy (macitentan+RT+TMZ), 4 weeks of monotherapy (macitentan) and 12 cycles of     maintenance therapy (macitentan+TMZ). The study will end when the last treated subject has     completed study treatment and the 30-day safety follow-up period.      The planned duration of the study is approximately 34-38 months depending on the number of     dose levels and cohorts of subjects enrolled. Subject participation in the study will be for     approximately 16 months.   "
78760|NCT02254941|"     The purpose of this study is to evaluate, in terms of overall survival, the benefit of     monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a     deferred basis after progression to treatment with chemotherapy alone.   "
78761|NCT02254928|"     A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of     corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian     stimulation of women with a poor ovarian response undergoing IVF treatments. The main     objective of this study is comparing the number of oocytes obtained after the follicle     puncture when using each of these two stimulation protocols. Only poor responders according     to the Bologna criteria will be recruited for this trial. All participants will undergo two     stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will     be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the     order of application of these protocols will be randomised (crossover clinical trial) in each     patient.   "
78762|NCT02254915|"     A multi-institutional, prospective, randomised, open-label, superiority, comparative,     active-controlled, phase 3 study. The study will compare Synergo RF-induced     hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus     Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and high-risk     NMIBC, and will evaluate recurrence and progression rate over two years of follow-up.   "
83020|NCT02199327|"     The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and     topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial     neoplasia.   "
78763|NCT02254902|"     There is a significant need for culturally adapted and effective health education programs to     address rising rates of obesity and chronic disease concerns for refugee communities.     Physical activity has been identified as an important prevention tool to prevent numerous     chronic health conditions. This research tests the feasibility and acceptability of a     culturally adapted physical activity intervention for sedentary adult Somali women. Study     participants will be randomized to a 3-month physical activity program or a wait-list control     group. The primary outcome is increases in physical activity between baseline and the end of     the program as measured by pedometer.   "
78764|NCT02254889|"     Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric     neoplasms. Although ESD-related complications such as bleeding and perforation have been     reported, data is currently lacking on the development of pain, which is one of the most     common adverse events after ESD. Therefore, in the present study, we investigated the     incidence and clinicopathologic risk factors of pain after ESD.   "
78765|NCT02254876|"     Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5% and     84% of patients, often having a strong impact on their well-being and resulting in delays     achieving rehabilitative objectives.      The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a     population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with     respect to pain, spasticity and range of motion.   "
78766|NCT02254863|"     The primary objective of the study is to determine the safety and feasibility of intrathecal     administration of DUOC-01 as an adjunctive therapy in patients with inborn errors of     metabolism who have evidence of early demyelinating disease in the central nervous system     (CNS) who are undergoing standard treatment with unrelated umbilical cord blood     transplantation (UCBT). The secondary objective of the study is to describe the efficacy of     UCBT with intrathecal administration of DUOC-01 in these patients.   "
78767|NCT02254850|"     The purpose of the study was to characterize the action of mesoglycan on vascular endothelium     through the non-invasive assessment of vascular reactivity humeral artery by comparing     effects of mesoglycan on Flow Mediated Dilatation (FMD) of the humeral artery between a group     of patients with metabolic syndrome assuming placebo and a group of patient with metabolic     syndrome assuming mesoglycan; firstly after administration of the drug/placebo     intramuscularly, and then, in a study of medium-term after oral intake of drug/placebo. The     selection of patients with metabolic syndrome is related to the fact that this syndrome is     associated with alterations in endothelial function and a high incidence of cardiovascular     events. So it is a condition that offers the opportunity to explore the hypothesis that the     mesoglycan may have a favorable effect on early vascular alterations that precede clinical     events.   "
78768|NCT02254837|"     Japanese post market clinical study of the Zilver PTX device.   "
78769|NCT02254824|"     The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in     hypertensive patients at low/moderate cardiovascular risk.   "
78770|NCT02254811|"     Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and     lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized     successfully. Endoscopic delivery requires significant health care utilization and associated     cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality,     which would significantly reduce patient discomfort, procedure related risks and health care     costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.   "
78771|NCT02254798|"     Validation of already described biomarkers on acute GVHD prediction and severity Fecal     calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha,     HGF   "
78772|NCT02254785|"     The purpose of this study is to assess and compare the clinical benefit rate in patients with     metastatic castrate-resistant prostate cancer and poor prognostic factors treated with     cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to     determine which treatment is most active in this population. Clinical benefit rate is defined     as PSA or measurable radiological response of any duration or stable disease for > or equal     to 12 weeks, in the absence of other indicators of progression.      There is option to cross-over onto the other arm if the patient progresses.   "
78773|NCT02254772|"     This phase I/II trial studies the side effects and best dose of ipilimumab in combination     with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients     with low-grade B-cell lymphoma that has returned. Monoclonal antibodies, such as ipilimumab,     may block cancer growth in different ways by targeting certain cells. Biological therapies,     such as TLR9 agonist SD-101, use substances made from living organisms that may stimulate or     suppress the immune system in different ways and stop cancer cells from growing. Radiation     therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving ipilimumab in     combination with TLR9 agonist SD-101 and radiation therapy may be a better treatment for     B-cell lymphoma.   "
78774|NCT02254759|"     This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to     investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe     CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity     and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid     (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive     allosteric modulator midazolam. The anticipated study duration is up to nine weeks.   "
78775|NCT02254746|"     The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation     Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is     the irradiation of the entire prostate gland with or without seminal vesicles accompanied or     not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of     hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and     highly efficient outpatient therapy.   "
78776|NCT02254733|"     This project is an effectiveness trial comparing two psychosocial treatments for     schizophrenia: Assertive Community Treatment (ACT) + Cognitive Behavioral Social Skills     Training (CBSST) v. ACT, alone.   "
78777|NCT02254720|"     Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of     BEA 2180 BR; additional exploration of metabolism following inhalation   "
83021|NCT02199314|"     Test the hypothesis to recruit larger motor responses to transcranial stimulation.   "
78779|NCT02254694|"     The purpose of this study is to investigate the influence of high heeled shoes on the     sagittal balance of the spine and the whole body.      The investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the     cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a     posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity.     This would be an explanation for the increased prevalence of back pain in individuals     frequently wearing high heels.      In order to assess these changes, differences in the two following outcome parameters will be     measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high     heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .   "
78780|NCT02254681|"     The overall goal of this study is to determine the safety and efficacy of combination     treatment of low-dose fractionated radiation therapy with gemcitabine-cisplatin chemotherapy     for locally advanced mass forming intra-hepatic cholangiocarcinoma.   "
78781|NCT02254668|"     Randomized prospective multi-center imaging study which investigates the impact of different     immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on     cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness     will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.   "
78782|NCT02254655|"     The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on     carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine     anti-rheumatic treatment.   "
78783|NCT02254642|"     Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular     complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful     in order to decrease these complications. The investigators would like to use an ischemic     preconditioning protocol during open surgery of aortic aneurysm in order to decrease these     complications.   "
78784|NCT02254629|"     the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the     fecal microbiota of the patients in a more robust manner .   "
78785|NCT02254616|"     Contemporary behavior interventions focused on upper limb training such as robotic-assisted     training and constraint-induced movement therapy have been proven to promote motor recovery.     However, the improvement is often of limited in practical significance. Mirror therapy (MT)     and transcranial direct current stimulation (tDCS) on brain based on similar principle of     utilizing brain plasticity have shown benefits in promoting motor function recovery and are     particularly easy to apply in different settings. tDCS activates a bulk of neural circuits in     a non-specific way, coupling tDCS with MT could steer plastic process toward a functional     direction. However, current evidence is insufficient to support the efficacy of tDCS as an     adjuvant to upper limb training, and long-term effect has yet to be explored.      Cortical stimulation clearly has its role in stroke rehabilitation. However, current evidence     is insufficient to support the efficacy of tDCS as an adjuvant to MT, and long-term effect     has yet to be explored. Therefore, this randomized clinical trial will aim to examine (1) the     beneficial effects of hybrid therapy (i.e., MT with tDCS) on health-related outcomes in     patients with chronic stroke; (2) the long-term benefits of the hybrid therapy on activity     participation at 6-month follow-up; (3) the underlying mechanisms of the hybrid therapy on     motor control and brain organization; (4) the correlations between brain excitability     patterns and movement kinematics/health-related outcomes. Accordingly, we will compare the     hybrid therapy vs MT with sham tDCS vs MT vs conventional intervention (CI) on motor     performance, daily function, and activity participation. We will also examine underlying     mechanisms by kinematic measures for motor control and fMRI analyses for brain     reorganization. The MT with sham tDCS group is included to achieve a double-blinded design     (patient and evaluator blinded) with the MT with real tDCS group. The MT only group is     included to examine if there exist a placebo effect of the presence of tDCS setting in the MT     with sham tDCS. The CI group is included to provide a baseline treatment to see if the other     three therapies induce larger improvements compared to currently standard therapy. We     hypothesize that (1) the hybrid therapy will induce greater improvements on some     health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month     follow-up; (3) better motor control and brain reorganization will be found in the hybrid     therapy than the other therapies; (4) correlations will be found between brain activity and     movement kinematics/health-related outcomes. This study will be the first to investigate     effects of the hybrid therapy, MT with tDCS, in chronic stroke. This study is unique in     examining changes at different levels including motor performance, daily function, and     activity participation, as well as brain and motor organization. To address the inconsistent     benefits in daily function outcomes in previous research in MT and tDCS in stroke     rehabilitation, we will modify the existing treatment protocols and include a 30-minute     functional training into each treatment session in all groups. The result of this project     might unveil a potentially better hybrid intervention for chronic stroke population to choose     from, compared to a stand alone therapy such as MT and CI. And the result will also provide     information on changes in motor control and brain organization which help understand the     underlying mechanism. The follow-up examination will provide information on long term effect     at the level of activity participation, which is crucial considering that chronic stroke     patients are most likely living in community. In addition, we may provide critical     information on the association between brain activity and movement patters/functional     outcomes in terms of analyzing the correlation of fMRI data with hand kinematics/     health-related outcomes.   "
78786|NCT02254603|"     The aim of this study is to examine the effects of combination of acupuncture and ayuveda     yoga exercise on weight loss for the overweight.   "
78787|NCT02254590|"     To evaluate a new endoscopic technique for lumbar spinal canal decompression.   "
78788|NCT02254577|"     To determine whether the of vaginal progesterone replacement for frozen embryo transfer     results in equivalent live birth rates to intramuscular injection progesterone replacement.   "
78789|NCT02254564|"     The main objective of this study is to identify unique DNA sequences within the genome of     human scabies that can be utilized to identify the parasite through PCR.   "
78790|NCT02254551|"     The purpose of the study is to determine whether the combination of LDE225 (sonidegib) plus     bortezomib is safe and effective in the treatment of relapsed or relapsed/refractory multiple     myeloma.   "
78791|NCT02254538|"     Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male     volunteers after oral administration of BILR 355 BS   "
78792|NCT02254525|"     The purpose of this study is to study the efficacy of intravenous administration of ibuprofen     compared to placebo in patients with postoperative pain and evaluate its tolerability and     safety profile.   "
78793|NCT02254499|"     Despite improvements in treatment, a significant part of patients have severe pain following     knee arthroplasty. Preoperative identification of high-risk patients would allow for an     intensive individualized analgesic treatment pre- and postoperatively and thus potentially in     reduced pain acute and chronically.   "
78794|NCT02254486|"     This study evaluates the efficacy, safety and tolerability of NER1006 with Trisulfate     solution in patients requiring bowel cleansing prior to any procedure which requires a clean     bowel. Half the participants will receive NER1006 and while the other half will receive     Trisulfate solution.   "
78795|NCT02254473|"     This study is looking at the efficacy of a sloped insole in patients with knee     osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in     a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain,     decreased use of over the counter analgesics, and a clinically important improvement in the     Womac pain and stiffness scale.   "
78796|NCT02254460|"     The present study supplements iron as part of multiple micro-nutrient supplementation to     demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake     of key micronutrients like iron due to unique nature of the given matrix, as compared to     intake of iron alone in milk.   "
78797|NCT02254447|"     This study will investigate the relative bioavailability of two candidate tablet formulations     of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product     ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an     open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18     healthy human subjects to ensure at least 14 subjects complete the study as planned. Each     subject enrolled will participate in all three treatment periods and will be assigned to one     of the six treatment sequences, in accordance with the randomization schedule. The treatment     periods will be separated by a washout period of at least 7 days and no more than 14 days     between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing.     ATACAND is a registered trademark of the AstraZeneca group of companies.   "
78798|NCT02254434|"     This study evaluates pharmacokinetics of eltrombopag 50 mg after the oral administration in     Mexican healthy volunteers under fasting conditions. The study will be an open label, single     dose study with 26 subjects planned to be enrolled. Healthy subjects (male and female) aged     between 18 - 50 years of age (inclusive) and a Body Mass Index within the range of 18-27.0     kg/meter (m)^2 (inclusive) were enrolled according to Quetelet. REVOLADE is a registered     trademark of the GSK group of companies.   "
78799|NCT02254421|"     This study will evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral     load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute     RSV lower respiratory tract infection (LRTI), the effect of presatovir on being free of any     supplemental oxygen, and rates of respiratory failure and all-cause mortality, and     pharmacokinetics (PK), safety, and tolerability of presatovir.   "
78800|NCT02254408|"     This study will evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral     load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute     RSV upper respiratory tract infection (URTI), the effect of presatovir on development of     lower respiratory tract complication, being free of any supplemental oxygen progression to     respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.   "
78801|NCT02254395|"     The purpose of this clinical study is to verify the long term effecacy and safety of a     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a     treatment option for patients with obesity.   "
78802|NCT02254382|"     This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants     with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV     device; therapy group). The trial will run for 6 months, after which change in     echocardiographic parameters of diastolic left ventricular function, sleep and quality of     life parameters will be evaluated.   "
78803|NCT02254369|"     The primary objective of the study is to assess the safety and tolerability of single oral     doses of GC021109 when administered to healthy adult subjects.   "
78804|NCT02254356|"     Japanese post market clinical study of the Zilver Flex device.   "
78805|NCT02254343|"     The purpose of this study is to compare the training effects of robot-assisted therapy focus     on proximal part, distal part, or total segment of upper extremity, respectively.   "
78806|NCT02254330|"     The objectives of this study is to assess the characteristics and frequency of adenovirus     conjunctivitis in a population of male and female patients from one year of age who present     signs and symptoms of acute conjunctivitis.   "
78807|NCT02254317|"     The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose     control in people with impaired glucose tolerance (IGT).   "
78808|NCT02254304|"     This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon     beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in     subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).   "
78809|NCT02254291|"     This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing     of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy     during 30 weeks of treatment in Japanese subjects with type 2 diabetes.   "
78810|NCT02254278|"     This randomized phase II trial studies the side effects and how well modestly reduced-dose     intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating     patients with oropharyngeal cancer that has spread to other places in the body (advanced).     Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy,     such as cisplatin, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. It is     not yet known whether IMRT is more effective with or without cisplatin in treating patients     with oropharyngeal cancer.   "
78811|NCT02254265|"     This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose     concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo     (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).   "
78812|NCT02254252|"     Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed     opacification of epicardial arteries in the absence of significant arterial narrowing and     blockade. Endothelial dysfunction at the level of microarteries have been proposed as the     main pathological mechanism in this regard. Available evidence suggest that standard     anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might     not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is     hypothesized that anti-angina medications which exert vasodilatory effects in large coronary     arteries as well as small dividing branches might be superior to nitroglycerin in     amelioration of angina symptoms. The present randomized clinical trial was thus designed and     conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina     medication with effects on both large and small coronary vessels) with nitroglycerin in a     group of patients with slow coronary flow presented with frequent angina episodes.   "
78813|NCT02254239|"     This phase I trial studies the side effects and the best dose of everolimus when given     together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has come     back (relapsed) or is not responding to treatment (refractory). Everolimus may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Brentuximab     vedotin may interfere with the ability of cancer cells to grow and spread by binding to a     protein on the surface of cancer cells and then releasing a cancer-killing substance to them.     Giving everolimus together with brentuximab vedotin may be a better treatment for Hodgkin     lymphoma.   "
78814|NCT02254226|"     1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg          Serevent ® MDI with sufficient precision so that in combination with a second trial it          can be demonstrated that the systemic drug exposure of a new formulation of salmeterol          xinafoate is not superior to that of Serevent ® MDI        2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of          Serevent ® Diskus ® and Serevent ® MDI        3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg          Serevent ® Diskus ®   "
78815|NCT02254213|"     The main objective is to evaluate the stability of EEG features on an individual level.   "
78840|NCT02253888|"     The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg     self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled     temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250     mg SEDDS capsules stored at controlled refrigerated conditions between 2°C and 8°C   "
78841|NCT02253875|"     Study to determine the effects of multiple-dose omeprazole on the single-dose     pharmacokinetics of tipranavir and ritonavir   "
78844|NCT02253836|"     Study to investigate the effects of steady-state TPV/r (500 mg/100 mg BID) on the single-dose     and steady-state pharmacokinetics of Atazanavir (300 mg QD) co-administered with Ritonavir     (100 mg). To investigate the effects of single-dose and steady-state Atazanavir (300 mg) on     the steady-state pharmacokinetics of Tipranavir and Ritonavir.   "
78816|NCT02254200|"     Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be     linked with an impaired ability to oxidize lipids, particularly in class III obese     individuals [Body Mass Index (BMI): > 40 kg*m-2]. Exercise training is an effective strategy     to improve insulin sensitivity and to reduce the risk of type 2 diabetes.      This study aimed to compare the effects of two different 2-wk-long training modalities     [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high     intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III     obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of     rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity     would be improved to a greater extent when adapted HIIT compared to Fatmax training.   "
78817|NCT02254187|"     The objective of this study is to investigate if the systemic drug exposure of at least 25 μg     and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered     via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety     and tolerability of salmeterol presented as inhalation powder in PE capsules and administered     via HandiHaler® 2   "
78818|NCT02254174|"     Assessment of the relative bioavailability of a fixed dose combination of tiotropium and     salmeterol compared to a free dose combination of the marketed products of tiotropium and     salmeterol (Spiriva® and Serevent® Diskus®).      Assessment of the relative bioavailability of a fixed dose combination of tiotropium and     salmeterol compared to tiotropium and salmeterol administered as individual mono substances     from the marketed products.      Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol     in a PE (Polyethylene) capsule administered via the HandiHaler® 2   "
78819|NCT02254161|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 1181181 in healthy young male and elderly male and female volunteers following oral     administration of repeated rising doses of BI 1181181, given once daily over 10 days.     Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics     (PD) of BI 1181181.   "
78820|NCT02254148|"     To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein     (P-gp) probe drugs as a means of predicting drug-drug interactions.   "
78821|NCT02254135|"     Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral     doses of BEA 2180 BR   "
78822|NCT02254122|"     Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK)     of BEA 2180 BR   "
78823|NCT02254109|"     Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese     healthy volunteers   "
78824|NCT02254096|"     The objectives are:        1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising          single doses.        2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT          1696 BS after grapefruit juice.        3. To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g          fat and high caloric breakfast.   "
78825|NCT02254083|"     Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg)     BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood     coagulation parameters   "
78826|NCT02254070|"     To assess the influence of different degrees of renal impairment on safety, tolerability,     pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose     infusion over 30 minutes in comparison to a normal renal function   "
78827|NCT02254057|"     Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0,     2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion     and to assess the effect of BIBT 986 BS on blood coagulation parameters   "
78828|NCT02254044|"     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine   "
78829|NCT02254031|"     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine   "
78830|NCT02254018|"     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine   "
78831|NCT02254005|"     Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine   "
78833|NCT02253979|"     Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT     exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation.     The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side     port. This study was designed to compare the VivaSightTM DL to the standard DLT.   "
78834|NCT02253966|"     Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for     osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It     has been suggested that preoperative degree of intraarticular inflammation is associated to     postoperative degree of pain and level of function. Furthermore it is known, that patients     with preoperative inflammation have hyperalgesia and severe movement related pain.      The aim of this study is to investigate the effect of a preoperative intraarticular injection     of Methylprednisoloneacetate in reducing acute postoperative pain after total knee     arthroplasty in patients with signs of severe pre-operative inflammation and pain.   "
78835|NCT02253953|"     Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a     single dose of BILR 355 BS dissolved in PEG 400   "
78836|NCT02253940|"     Study to determine the single dose, relative BA of new SDS-containing formulations of BILR     355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet     formulation (50 mg tablet)   "
78837|NCT02253927|"     The primary objective was to explore the relative bioavailability of increasing doses of BILR     355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with     ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.      A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355     (SDS)   "
78838|NCT02253914|"     Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose     ritonavir in healthy male volunteers.   "
78845|NCT02253823|"     The objective of this study was to characterize the effects of two dose combinations of     tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg), administered daily     and BID, on the pharmacokinetics of efavirenz (EFV), 600 mg daily   "
78846|NCT02253810|"     The goal of this randomized controlled, double-blinded trial is to assess the efficacy of     intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients     undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint.     The investigators hypothesize that tranexamic acid will be more effective than placebo     (normal saline solution) in reducing blood loss and transfusion after periacetabular     osteotomy.   "
78847|NCT02253797|"     Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion     and mass balance of parent compound and radioactivity at steady-state; to isolate, identify     and quantify major metabolites of tipranavir in plasma, urine and feces   "
78848|NCT02253784|"     The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the     duration of a block in total knee arthroplasty. The aim of this study is to determine whether     this is a systemic or local effect.   "
78849|NCT02253771|"     The purpose of this study is to determine whether shockwave therapy is more effective in the     treatment of unspecific acute low back pain than sham therapy.      60 patients with acute low back pain will be recruited to a single-blinded, randomized,     placebo-controlled trial. They are randomized to receive either shockwave therapy or sham     treatment by a identically looking device for 4 weeks, twice a week. Additionally patients     receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if     necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every     week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The     clinical outcome will be primarily measured by pain intensity using a visual analogue scale.     Secondary outcome measures are Oswestry Disability Index, Beck`s Pain Depression Scale,     Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the     difference in change of scores between groups using one-way t-test.   "
78850|NCT02253758|"     Emergence from sedation involves an increase in both the level of consciousness and arousal.     Some insight to the neural core of consciousness was gained in the recent past. Our research     objective is to characterize for the first time the spatiotemporal mobilization of the     ascending reticular activating system during emergence from sedation; stated otherwise - to     capture the neural core of arousal.      To achieve this objective we plan to utilize the advanced imaging modality of EEG-fMRI. In     short, volunteers will be placed in the MRI. Following baseline recordings they will be     sedated with a continuous drip of propofol, titrated to deep sedation. Once in that sedation     level, propofol administration will cease until emerging to an awake-calm/light sedation.      Continuous EEG recordings and fMRI scans will be taken, both task specific (auditory oddball)     and resting-fMRI. Analyses will focus (but will not be restricted to) on constituents of the     ascending reticular activating system.      The expected advances of this proposal are:        1. Emergence from sedation (and anesthesia) is one of the critical stages and least          elucidated area in the practice of anesthesia. Delayed awakening of varying degree is          not uncommon after anesthesia and may have a number of different causes, individual or          combined, which may be both drug or non-drug related, thus causing a diagnostic dilemma.          Eventually - better insight into this subject will lead to better clinical practice and          better understanding why patients emerge in such a diverse and sometimes unexpected          manner.        2. Knowledge of the internal structure underlying arousal from anesthesia will help develop          / upgrade brain monitors that could tell the anesthesiologist the patient's level of          consciousness and prediction of arousal.        3. A detailed reproducible mapping of the arousal process may serve as the core of a drug          screening platform for drugs that may expedite patient arousal.        4. Elucidation of the arousal paradigm from sedation will enhance our knowledge of          physiological sleep.      Research hypothesis      Return of consciousness is a complex phenomenon comprising of interplay between the cortex     and deeper brain structures. We hypothesize that the activation signature is conserved and     similar between subjects. Furthermore, we hypothesize that inter-subject variability will     arise mainly in the time domain, as evident from the clinical observation of variable time to     emergence in different patients.   "
78851|NCT02253745|"     The purpose of this research study is to evaluate the safety, tolerability, effectiveness,     and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD.     Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and     eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood     samples will be taken throughout the study for PK analysis.   "
78852|NCT02253732|"     The purpose of this study is to determine specific changes in muscle secretory profile     (myokines, miRNA) in association with neurodegenerative disease progression and metabolic     dysfunction. Next the investigators would like to determine the shift in the muscle secretory     activity induced by regular exercise intervention, which the investigators think could be     translated into the beneficial changes in clinical phenotypes, determined by neuroimaging,     cognitive function tests and metabolic phenotyping.   "
78853|NCT02253719|"     The prevalence of cervical neoplasia in Cambodia is not known. There are no screening     programs in place. The investigators plan on introducing a screening program based on WHO     criteria and utilizing visualization with acetic acid. Patients who are positive will be     offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and     hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of     whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).   "
78854|NCT02253706|"     In general bronchoscopy is a safe procedure with low rate of complications. Indeed,     contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is     the case of preexisting decreased blood oxygen levels which may be present in patients     requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen     drops oxygen supplementation is recommended.      The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation     obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula     during flexible bronchoscopy.      Consecutive patients referred by their treating physician for bronchoscopy will be offered to     take part in the study. Those who wish to participate and give their consent will be randomly     assigned into one of two treatment groups (supplemental oxygen given via low flow nasal     cannula or via high flow nasal cannula).      Assignment to either treatment arm will not affect in any way the intended purpose of the     bronchoscopy. All patients will be closely monitored during the procedure and 2 hours     following its completion. Monitoring will be conducted, using strictly non-invasive measures.   "
78868|NCT02253524|"     -  Vertigo complaint is one of the common cause of patients who applied to emergency          services.        -  Patients who have applied to emergency services with vertigo complaint mostly have          nausea as an additionally symptom to this complaint and anti-emetic agents can be used          in their treatments very often.        -  The investigators purpose is to investigate the advantages of Dimenhydrinate and          metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by          nausea   "
80547|NCT02231619|"     The purpose of the study is to design a self-assessment package that could be the preferred     option to a follow-up visit at the clinic by the majority of women having early medical     abortion.   "
78855|NCT02253693|"     Research Question: Does an specific and pre-defined physical exercise prescribed by a     specialist provide any benefit on haemophilic arthropathy, the quality of life or the     physical condition of patients with haemophilia A and haemophilic arthropathy? Does adherence     to physical exercise improve when monitoring patients with an accelerometer? Do compliant     patients find higher benefit on haemophilic arthropathy, quality of life or the physical     condition than non-compliant patients?      Primary Endpoint: Assess in patients with haemophilia A and haemophilic arthropathy if a     prescribed and specific physical exercise monitored by an accelerometer is producing any     change in the following domains: progress of haemophilic arthropathy; health-related quality     of life; physical condition.      Secondary Endpoints: Evaluate the adherence to physical exercise in patients with haemophilia     A and haemophilic arthropathy by means of accelerometry, and asses if compliant patients     achieve higher improvement in these 3 domains than non-complaint patients.   "
78856|NCT02253680|"     The use of compression bandages in elective orthopaedic knee surgery is well regarded,     however, there is a lack of robust, well-designed evidence to support this.      The aim is to determine the feasibility of conducting a randomised control trial comparing     the use of a compression bandage worn post-operatively for 24 hours after elective total knee     replacement, compared to standard practice (wool and crepe, non-compressive dressing).   "
78857|NCT02253667|"     The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and     90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.      Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide,     Heliox 28 and oxygen.      Conventional oxygen supplementation is often used in these patients, but it may be     inadequate, especially if they require high flows (from 30L/min to 120L/min in acute     respiratory failure).      High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen     system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which     generates the gas flow rate up to 55 L/min and a heated humidification system. This     technology may have an important role in reducing respiratory distress in do-not-intubate     patients.      Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing     rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration;     a better matching between patient's inspiratory demand and oxygen flow; generation of a     certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure     and recruitment; improvement of lung and airway mucociliary clearance due to the heated and     humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and     speech.      The investigators hypothesize that patients supported with HFONC need less opioids to     decrease dyspnoea.   "
78858|NCT02253654|"     The purpose of this study is to compare two different dosing methods of epoetin alfa and     their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients     with chronic kidney disease (CKD) receiving hemodialysis.   "
78859|NCT02253641|"     This study evaluates the efficacy of a stress-focused tailored weight loss intervention     compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0)     African American women.   "
78860|NCT02253628|"     This study investigated the acute effect of the consumption of four different kinds of coffee     (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine     content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported     gastrointestinal symptoms and on psychometric assessments in healthy individuals.   "
78861|NCT02253615|"     The latest randomized controlled trials and systematic reviews of resistance training     performed by older adults reported that the systematic use of exercise in machines improves     muscle strength and power, functional abilities, body mass and body balance. However, the     effect of resistance training with elastic tubes exercises have not been studied in all the     variables described above. The objective of this study is to analyze the effects of elastic     tubes exercises on muscle mass, muscle strength, functional performance and postural control     in elderly untrained.   "
78862|NCT02253602|"     The current standard treatment of resectable esophageal cancer consists of neoadjuvant     chemoradiation followed by resection. However, some patients develop recurrent disease     despite chemoradiation and additional (systemic) treatment might have been indicated. Other     patients show a (nearly) complete response after chemoradiation and could possibly have been     treated with a less extensive treatment regimen. In patients without a threatened     circumferential resection margin (CRM) and lymph node metastases chemoradiotherapy could     possibly be omitted.      Better stratification of patients with esophageal cancer is therefore urgently needed.     Functional magnetic resonance imaging techniques (MRI) can provide in vivo, quantitative     information on tumor biology and may prove to be a useful non-invasive tool for this purpose.     In this project, ultra-small superparamagnetic particles of iron oxide (USPIO) enhanced MRI     using ferumoxytol (Rienso®), diffusion weighted MRI (DWI) and T2* MRI will be developed, both     in terms of improvement of acquisition and data processing techniques.   "
78863|NCT02253589|"     Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to     a one-session brief intervention or waiting list. Reductions in khat use will be measured     from pre- to post-assessment which will be one month apart. After one month, the waiting list     will receive the same intervention.   "
78864|NCT02253576|"     Study Design: This randomized, double blind, controlled, multi-centre study will occur in the     Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics     (collectively ED) of 3 General Hospitals in Ontario and 1 in British Columbia.   "
78865|NCT02253563|"     Comparison of resistance training versus balance training to improve postural control in     patients with Parkinson's Disease   "
78866|NCT02253550|"     This study will look at the safety and efficacy of 8 week and 12 week treatment with     Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic     hepatitis C genotype 4.   "
78867|NCT02253537|"     To compare the results of the investigational test to the currently approved QuantiFERON-TB     Gold In-Tube test.   "
78930|NCT02252705|"     Prospective multicenter registry including incident patients and prevalent patients which     pretends to identify clinical characteristics, treatment trends in-hospital and four years     follow-up outcome through major adverse cardiovascular events (MACE) in a Mexican population     with well characterized Pulmonary Hypertension.   "
78869|NCT02253511|"     Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different     regions of the world. The 5-year risk of recurrence of HCC after resection has been reported     to be as high as 70%. It has been proposed that best way to reduce recurrence is to search     for improved adjuvant therapies. Especially for some postoperative patients who were     identified with the risk factors for recurrence, several adjuvant therapies were often used,     including TACE. Recently, a variety of Traditional Chinese Medicine combined with TACE for     toxicity reduction and enhancing the efficacy have been investigated in the treatment of HCC.     Cidan capsules are a formula containing more than ten types of plant extracts, and has been     clinically used for >10 years as a safe and nontoxic antitumor drug. However, the safy and     efficacy of preventive therapy is still not clear. In this prospective control study, we     enroll such HCC patients experienced operation and were identifed with high risk of     recurrence. After a preventive TACE, the eligible patients were divided into two groups. One     group will accept Cidan therapy and another will not. Under a basis of large sample, the     safty and efficacy of Cidan combined with TACE in HCC patients will be investigated and     analysed.   "
78870|NCT02253498|"     The purpose of this clinical study is to verify the long term effectiveness and safety of a     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a     treatment option for patients with cognitive, behavioral, and functional disability of     Tourette Syndrome.   "
78871|NCT02253485|"     Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV)     infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born     to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is     evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg     positive mothers with high serum HBV DNA loads.   "
78872|NCT02253472|"     The purpose of this clinical study is To verify the long term effectiveness and safety of a     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a     treatment option for patients with cognitive, behavioral, and functional disability of     Obsessive-Compulsive Disorder.   "
78873|NCT02253459|"     The purpose of this study is to determine whether UTD1 Injection in combination with     capecitabine is effective in the treatment of advanced metastatic breast cancer using     capecitabine as a control.   "
78874|NCT02253446|"     -  Currently, nonsteroidal antiinflammatory drugs are widely used by emergency physicians          in Turkey for the treatment of patients with Primary Dysmenorrhea.        -  The objective of the study is compare intramuscular Diclofenac sodium and piroxicam's          pain reduction dysmenorrhea in emergency department (ED) adults.        -  The investigators second aim was to compare recurrent dysmenorrhea pain within 24 hours          after discharge.   "
78875|NCT02253433|"     The purpose of this study is to improve the health of African-American adults who have poorly     controlled asthma. The study will compare a home-based exposure reduction and asthma control     intervention to enhanced in-clinic care that includes a standard clinical appointment as well     as information from a detailed exposure history, asthma education, assessment for allergies,     and a customized asthma self-management plan developed using motivational interviewing. The     interventional group receives enhanced in-clinic care, as well as a customized home-based     environmental exposure assessment and multicomponent exposure reduction and asthma control     intervention (five home visits over approximately 12 months).   "
78876|NCT02253420|"     To evaluate the effect of itraconazole or rifampin on the absorbtion, distribution,     metabolization and elimination of COPANLISIB (BAY80-6946) To evaluate the effect of     copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of     cardiovascular safety   "
78877|NCT02253407|"     This is a study planned to determine and compare immunogenicity and reactogenicity of MMR     vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or     disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.   "
78878|NCT02253394|"     The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary     Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if     spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps     every minute), right ventricle function and quality of life.   "
78879|NCT02253381|"     Hypotension is the most common complications after spinal anesthesia especially in pregnant     patients who undergoing cesarean section. Position during spinal anesthesia may be altering     the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena     cava that may decrease venous return and cardiac output. This leads to hypotension.The     hypothesis is the right lateral position during spinal anesthesia in pregnant women will be     had hemodynamic changing more than the left lateral position. This objective is to compare     hemodynamic change between left and right lateral position during spinal anesthesia in     pregnant women undergoing cesarean section.   "
78880|NCT02253368|"     Bedtimes and wake-up times vary from person to person. The aim of this research is to examine     the associations between sleep habits and metabolism in healthy people. In this study, the     investigators will collect information on sleep-wake habits and how the body uses energy.   "
78881|NCT02253355|"     Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with     Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to     evaluate the influence of acupuncture on patients, which will be afford objective evidence     for the mechanism of Acupuncture on depression.   "
78882|NCT02253342|"     This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar     macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in     healthy adult subjects.   "
78883|NCT02253329|"     In the present study, the effect of a bolus of intrinsically labeled milk directly after     one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions:     during the day and prior to sleep   "
78884|NCT02253316|"     The purpose of this research study is to evaluate a treatment regimen called IRD which will     be given to participants after their stem cell transplant in an effort to help prolong the     amount of time the participants are disease-free after transplant. IRD is a three-drug     regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone. After     4 cycles of IRD, the participants will be randomized to receive maintenance therapy either     with ixazomib or lenalidomide.   "
78889|NCT02253251|"     The investigators will recruit and enroll individuals that may have the KRAS-variant or other     microRNA binding site mutations to join registry studies. The investigators will allow     individuals to obtain their results through a physician at the completion of the studies. The     investigators current focus is breast cancer.   "
78890|NCT02253238|"     The goal of this research study is to learn if home-use of devices to identify dehydration     risk, when added to standard care, will help to lower hospitalizations and emergency room     visits (and related costs) in patients with head and neck cancer.      CYCORE is a software-based system that enables comprehensive collection, storage and analysis     of information related to cancer research and clinical care. In this study, those in the     CYCORE group use devices at home to measure their dehydration risk. This information is     monitored by their clinicians. Those in the standard care group complete health based     surveys, as do those in the CYCORE group.   "
78891|NCT02253225|"     The investigators propose to examine both resting state activity and functional activity     during rumination and during self-processing to study the relationship between neural     correlates of rumination/self-focus and self-processing in major depression and bipolar     disorder.   "
78892|NCT02253212|"     PURPOSE: The purpose of this study is to determine whether transient opening of the     blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is     safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery     of carboplatin-based chemotherapy.      STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior     to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of     the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to     carboplatin-based chemotherapy and increase progression-free and overall survival in patients     with recurrent glioblastoma.   "
78893|NCT02253199|"     Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children.     We performed a up-down sequential allocation study to determine the ED50 for rescue sedation     following sedation failures in children and to investigate age-related differences in the     rescue sedation with dexmedetomidine.   "
78894|NCT02253186|"     The objective of the study is to assess the effect of a new Armsleeve, worn during the night     during maintenance phase of upper limb lymphoedema treatment in combination with Day-time     usual lymphology hosiery.   "
78895|NCT02253173|"     This study will assess the safety and efficacy of a new formulation of vaginal estradiol for     the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.   "
78896|NCT02253160|"     The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate     the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared     to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject     safety will be evaluated beginning with mobilization, throughout the collection procedure and     for the day following the last collection.   "
78897|NCT02253134|"     The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of     an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of     suspected arrhythmic origin, within 30 days before enrollment.   "
78898|NCT02253121|"     Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid     pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of     COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced     hyperglycemia (defined as known type 2 DM or glucose > 10mmol/l at admission) will be     randomized to treatment of dapagliflozin or placebo orally, once daily.      Percentage of time within glucose target range (3,9-10 mmol/l) and incidence rate of     hypoglycemia will be compared between dapagliflozin group and placebo group.   "
78899|NCT02253108|"     The purpose of this study is to compare early vessel healing after implantation of SYNERGY     drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.   "
78902|NCT02253069|"     To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in     full-thickness surgical wounds in dermatologic surgery in order to minimise the development     of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and     postoperatively will be examined in order to understand the pathogenesis of surgical site     infections better.   "
78903|NCT02253056|"     The aim of this pilot study is to evaluate the effects of one regular fasting day per week     over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.   "
78904|NCT02253043|"     Purpose: The purpose of this clinical study is to verify the long term effectiveness and     safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd.     as a treatment option for patients with cognitive, behavioral, and functional disability of     Alzheimer's disease.   "
78905|NCT02253030|"     The primary goals of this study are to use optical coherence tomography (OCT) angiography     (blood vessel mapping) to:        1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)        2. evaluate patients undergoing treatment for wet AMD        3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.   "
78906|NCT02253017|"     The purpose of this observational study is to assess the therapeutic strategies in the     treatment of pediatric cataracts.   "
78907|NCT02253004|"     In a double blind placebo-controlled cross-over study the effect of cilostazol on aura     induction and endothelial response is tested in patient with migraine with aura.   "
78908|NCT02252991|"     This trial will measure the fatigue in breast cancer patients.      Two groups of patients will be realised:        -  Arm A: Physical activity during treatment        -  Arm B: No physical activity during treatment but after      The aim of the study is to decrease fatigue, with adequate physical activity, in primary     breast cancer patients who receive a treatment for their pathology.   "
78909|NCT02252978|"     This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in     diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for     examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections     caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to     lower abnormal prostate-specific antigen (PSA) levels caused by bacterial infection of the     prostate gland and may or may not affect the detection rate of prostate cancer.   "
78910|NCT02252965|"     This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial     in which metformin extended release (XR) will be compared with metformin immediate release     (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with     Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent     (%).   "
78911|NCT02252952|"     The purpose of this study is to investigate the effects of consumption of sugar sweetened and     diet beverages on overall fat mass and the fat mass of various tissues implicated in the     dysregulation of glucose metabolism. In addition, hypothalamic activity will also be     investigated after acute exposure to sugar sweetened and diet beverages, and again after 6     months of daily consumption.   "
78912|NCT02252939|"     The investigators are doing this research study to discover factors, such as job, hobbies, or     race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis     is one of the most common kinds of arthritis. About 116 people will take part in this     research study at Massachusetts General Hospital (MGH).   "
78913|NCT02252926|"     Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and     painful adverse effect caused by the radio therapy and/or chemo therapy patients with head     and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the     current treatment with opioids is not sufficient and can cause adverse effects.      Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce     the oral pain caused by mucositis compared with the current standard treatment.   "
78914|NCT02252913|"     The purpose of this study is to evaluate the safety and tolerability of volitinib in     combination with docetaxel in patients with locally advanced or metastatic gastric cancer and     to determine the Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of     volitinib in combination with docetaxel.   "
78915|NCT02252900|"     Primary objective: To describe the evolution of cerebral lesions in IE patients (number of     patients with abnormal cerebral MRI in acute phase of IE and during follow-up).   "
78916|NCT02252887|"     The purpose of this study is to see if a combination of drugs can help to treat breast     cancer. This is a Phase II study which will test whether this combination of drugs is     effective and will provide further information on side effects and safety. A standard     chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2 receptor.     The HER2 receptor is a growth protein on the surface of some breast cancer cells that     provides messages telling the breast cancer cell to grow. The standard chemotherapy will be     gemcitabine.. The other two drugs work against HER2. One is called trastuzumab (Herceptin)     and it is commonly given to women with advanced and early HER2 positive breast cancer. The     other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast     cancer. The drugs in this study are each individually approved for the treatment of     metastatic breast cancer. However, this study is looking at the effectiveness of gemcitabine     with trastuzumab and pertuzumab when given to women who have advanced HER2 positive breast     cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based therapy.   "
78917|NCT02252874|"     This project is aimed to find out whether action video games can enhance dynamic visual     function and improve balance function in the community-dwelling older adults. It is also     aimed to examine the relationship between dynamic visions and balance functions.   "
78931|NCT02252692|"     Phase I study in healthy adult male and female volunteers to compare the bioavailability of     enalapril administered in orodispersible Minitablets with or without water in comparison to     the standard galenic tablet formulation of enalapril. The standard pharmacokinetic parameters     will be calculated from the bioanalytical results for enalapril and enalaprilat and compared     in a descriptive statistical analysis.   "
78932|NCT02252679|"     The purpose of this study is to determine whether mass spectrometry analysis of stable     (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of     bone and calcium disorders.   "
78918|NCT02252861|"     Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium     that can induce cerebral vascular events or systemic embolisms. This justifies the     prescription of anticoagulant therapies in patients with high risk of thromboembolic event.     Percutaneous left atrial appendage closure is a new interventional strategy for patients with     high risk of cardiovascular events and a counter-indication for long term treatment with     anticoagulant agents. However, only few data are available on effectiveness and prognosis of     patients treated by this new interventional strategy.      This national database record per-procedure and follow-up data of patients treated by left     atrial appendage closure.      This database is strictly observational.      Percutaneous left atrial appendage closure is performed only for the purpose of patient care.     No specific intervention is performed specifically for the database. Neither left atrial     appendage closure procedure nor patient follow up are modified by patient inclusion in the     database.   "
78919|NCT02252848|"     Hypoxic ischemic encephalopathy (HIE) occurs in ~ 2-4/1000 term infants and is a major cause     of neonatal morbidity and mortality. To date, therapeutic hypothermia started within 6 h of     birth is the only intervention known to be effective in reducing the morbidity and mortality     of HIE. Hypothermia does not totally reverse the injury in many infants and is associated     with side effects that may compromise its effectiveness. Low dose morphine is often used to     reduce shivering in infants undergoing therapeutic hypothermia, but escalating doses of     sedatives/analgesics are often required. Escalating doses of opioids and benzodiazepines     causes respiratory depression and can either cause the need for or prolong mechanical     ventilation.Agonists to the central a2 - adrenergic receptors are more effective at reducing     postoperative shivering than opioid receptor agonists and provide analgesia and sedation     without respiratory depression. The most desirable sedative-analgesic agent used in infants     with HIE would: (a) have an excellent safety profile, (b) reduce shivering, (c) provide     adequate analgesia and sedation, (d) cause minimal respiratory depression, (e) preserve     cerebrovascular autoregulation, and (f) confer neuroprotection.   "
78920|NCT02252835|"     The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and     potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult     population with gout.   "
80548|NCT02231606|"     The aim of the project is to create, study and advocate for a model that can be adopted by     the Chinese government to provide spectacles for all children sustainable.   "
78921|NCT02252822|"     Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek     treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of     disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN often     go unnoticed by parents and clinicians.      In order to eliminate the barriers that prevent adolescents from seeking treatment, this     study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for     BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and     acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been     found to be as effective as specialized treatments, and more cost efficient.      To remain anonymous and accessible, the self-help approach in this study will be provided in     a non-guided, or pure format (only online sessions). Studies support that a pure self-help     methodology is as effective as a guided version.      Although anonymity may improve accessibility, this study design could also pose challenges in     areas such as recruitment, treatment completion and obtaining adequate informed consent.     Therefore, before embarking on a larger randomized control trail, we would like to propose a     small, non-controlled feasibility study to assess potential issues in these areas.      Primary hypotheses:      Recruitment: Based on communication with public health nurses in the high schools we plan to     recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month     period from each of the 5 schools, and 1-5 from social media outlets such as Instagram,     Twitter, Facebook for a total of 5 participants over a 4-month period.      Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we     hypothesize that approximately 15% of participants will not complete any sessions, and many     will only complete about half of the sessions.      Informed consent: Based on information from large randomized control studies in the UK, we     hypothesize that adolescents will be capable of providing online consent, and that we will be     able to adequately obtain consent without verbally communicating with participants.      Secondary hypothesis:      We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner     will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to     baseline.   "
78922|NCT02252809|"     The main objective of this study is to characterize the biological responses elicited by     endotoxin inhalation applied to healthy subjects, and to assess the effect of standard     anti-inflammatory agents (i.e. adalimumab and methylprednisolone) on these biological     responses.   "
78923|NCT02252796|"     This study will help researchers test the safety of hypofractionated dose of radiotherapy     (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung     Cancer.   "
78924|NCT02252783|"     BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in     subjects with known or suspected coronary artery disease (CAD) as compared to standard     nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or     suspected CAD subjects.   "
78925|NCT02252770|"     This is a study involving a dietary supplement. Patients with argininosuccinic aciduria will     be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 2     weeks, and then crossed-over to receive the other treatment for two weeks.      The investigators expect to see that : 1) Patients with ASA will have a decreased ability for     their arteries to dilate due to nitric oxide deficiency, 2) Treatment of ASA with the nitric     oxide supplement will improve the ability of their arteries to dilate, and 3) Through the     testing of subjects' fibroblasts (cells in connective tissue that produce collagen and other     fibers), the investigators hope to predict which patients may respond NO supplementation.   "
78926|NCT02252757|"     Heart failure is a common cardiovascular problem which is increasing in both prevalence and     incidence and associated with substantial morbidity and mortality. The management of heart     failure patients is complex and has become a priority world over. Effective methods to keep     heart failure patients out of the hospital are essential, both in the interests of the     patient's health, as well as to reduce the burden on the health care system   "
78927|NCT02252744|"     This study will evaluate the prevalence of dry eye disease in patients diagnosed with     rheumatoid arthritis. No treatment is administered in this study.   "
78928|NCT02252731|"     This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics     (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin     alone and in combination with multiple doses of FG-4592, and will evaluate the effect of     multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.   "
78929|NCT02252718|"     The aim of this study is to assess interobserver and intraobserver variability of the     Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating     in the study it will be assessed using the Amsterdam Stool Scale independently by one of the     parents and the medical doctor. At the same time a parent will take 2 photos that will be     independently evaluated by another doctor.   "
78933|NCT02252666|"     The investigators hypothesis is that electrical stimulation to the tongue that directly     stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural     impulses to the brainstem and cerebellum. The investigators call this cranial nerve     non-invasive neuromodulation (CN-NINM). The activation of these structures induces     neuroplasticity when combined with specific physical exercises, can reduce symptoms of     advanced MS, targeting primarily postural stability (sitting and standing), upper extremity     movement, and ability to perform self-transfers.   "
78934|NCT02252653|"     The purpose of this study is to characterize the frequency of TTR mutations in subjects     suspected of having cardiac amyloidosis   "
78935|NCT02252640|"     The purpose of this study is to assess two types of new malaria vaccines in different     combinations. The study will enable us to assess:        1. The ability of the vaccines to prevent malaria infection.        2. The safety of the vaccines in healthy participants.        3. The response of the human immune system to the vaccines.      We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then     exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under     carefully regulated conditions. We will follow participants closely to observe if and when     they develop malaria. If the vaccine combination provides some protection against malaria,     participants will take longer to develop malaria than usual or will not develop malaria at     all. We will also recruit 4 individuals to be control subjects - these participants won't     receive any vaccinations but will be challenged with malaria.      Vaccinated volunteers who do not develop malaria infection in the blood after being infected     with malaria by mosquito bite the first time may be invited back to be again infected with     malaria in a repeat challenge experiment. This would happen approximately 5-7 months after     the first challenge. The purpose of this second challenge will be to see how long the     protection of the investigational vaccine against malaria lasts.   "
78948|NCT02252471|"     This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with     master's level mental health professionals within a juvenile justice setting; 2) determine     acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment     satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk     of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).   "
78936|NCT02252627|"     During operations to treat abdominal problems the blood pressure can fall, resulting in falls     in blood flow to the vital organs. This fall can be treated by the administration of drugs     that cause constriction of blood vessels. Although these drugs correct falls in blood     pressure, it is unclear what effect they have on blood flow from the heart and to the vital     organs.      In this study of healthy volunteers we aim to better understand the changes in blood flow in     both small and large vessels that occur in response to administration of these drugs. To do     this we will use two different techniques of ultrasound imaging. A narrow (4-5mm) ultrasound     probe will be inserted into the oesophagus via a nostril to measure blood flow in a major     blood vessel. A second probe will rest on the abdomen and will record changes in blood flow     in small vessels of the liver. Two drugs which raise the blood pressure via different     mechanisms will be administered and the changes in flow from the heart and to vital organs     will be measured and compared.   "
78937|NCT02252614|"     Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of     paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour     after a lumbar disk surgery.   "
78938|NCT02252601|"     The purpose of this study is to find out whether the High Frequency Digit Triplet test can be     used to screen patients with cystic fibrosis for hearing loss in conditions of health and     pulmonary exacerbation. It is also designed to find out the youngest age at which a child can     perform the test, the prevalence of hearing loss in a CF population and the prevalence of     genetic mutations known to be associated with hearing loss in the same population.   "
78939|NCT02252588|"     Determine the effect of twice-daily chlorhexidine oral rinse on oral and lung microbiota     biomass in subjects with chronic obstructive pulmonary disease (COPD) with chronic     bronchitis. Our primary outcome will be to compare the microbiota biomass (number of bacteria     as measured by 16S rRNA copy number) of induced sputum and the oral cavity before and after 8     weeks of twice-daily chlorhexidine oral rinse (n=25) compared to controls (n=25) using qPCR     and next-generation sequencing of the bacterial 16S rRNA gene comparing total bacterial     biomass   "
78940|NCT02252575|"     E-Transportation is increasing all over the world. It is not known if the used engines     interfere with cardiac implantable electronic devices. The study evaluates such potential     interferences in vivo.   "
78941|NCT02252562|"     Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public     health concerns that impact all areas of healthcare. Further work is needed to better     understand these healthcare issues so that effective preventive measures can be developed.      The investigators have developed and validated an experimental model for studying the risk     factors for bacterial cross contamination in the surgical operating room. The investigators     have confirmed in our previous work that intraoperative bacterial transmission events occur     frequently both within and between surgical cases and that these transmission events are     linked to 30-day postoperative HCAIs and increased patient mortality.      In response, the investigators have implemented various strategies designed to bacterial     transmission in the operating room, including anesthesia provider hand hygiene compliance.     The investigators' recent work in the intensive care unit suggests that the hand hygiene     system the investigators have previously studied could be further optimized.      The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene     system enhanced with novel wireless technology designed to facilitate real-time group and     individual performance feedback.      The investigators hypothesize that the use of this system will increase hourly hand     decontamination events of anesthesia and circulating nurse providers and reduce 30-day     postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay     duration, and hospital re-admission rates, and mortality(secondary outcomes).   "
78942|NCT02252549|"     This study is a multicenter randomized controlled trial in which the efficacy between SPIES     assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will     undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive     treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as     short and long-term follow up.   "
78943|NCT02252536|"     The purpose of this study is to determine whether gabapentin enacarbil is effective in the     treatment of problems with alcohol.   "
78986|NCT02251977|"     The primary objective of this study is to assess the efficacy of     monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in     colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.   "
78944|NCT02252523|"     This will be an open, prospective pilot study with pharmacological analysis. This study is     designed to assess the efficacity and safety of dexmedetomidine-based sedation in two     subgroups of neurocritically ill patients requiring mechanical ventilation for more than 48     hours. Those with or at risk for intracranial hypertension requiring deep sedation and those     requiring a light to moderate sedation for early neurological evaluation.      The main objective is to assess the feasability of dexmedetomidine infusion in terms of     efficacy and safety (especially cardiovascular tolerance) in brain-injured patients admitted     to intensive care unit and requiring sedation and mechanical ventilation for a predictable     duration greater than or equal to 48 hours. Secondary objectives include the study of     hemodynamic parameters evolution, dose-response relationship, blood (+/- cerebrospinal fluid)     drug concentration, opioates and co-hypnotic consumption.   "
78945|NCT02252510|"     It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This     measurement helps to better diagnose male infertility and seems easy to apply in routine.     However, the reliability of this method needs to be evaluated before applying for clinical     practice in andrology laboratory.   "
78946|NCT02252497|"     The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid     (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over     height hours on blood loss.   "
78947|NCT02252484|"     The purpose of this study is to evaluate the effectiveness of a weight management program for     men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight     gain, and reduces risk of cancer recurrence in the participants.   "
78975|NCT02252120|"     The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic     position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in     non-paralyzed anaesthetized pediatric patients   "
78949|NCT02252458|"     The purpose of this study is to examine whether two clinically sensible dose regimen of     fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal     rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain     modalities tested will include transdermal electrical stimulation and cold pressor pain.      The investigators hypothesize that the high dose fentanyl group will have an increase of     approximately 20% in the NRS.   "
78950|NCT02252445|"     The investigators want to evaluate the efficacy of the propofol and sevoflurane for the     prevention of catheter-related bladder discomfort.   "
78951|NCT02252432|"     The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar,     an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after     lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of     both drugs may be able to provide better control of pain after lumbar surgery.   "
78952|NCT02252419|"     The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the     prevention of postoperative sore throat.   "
78953|NCT02252406|"     The purpose of this study is to determine the effects of ranolazine on different markers of     cardiometabolic disease in women with stable angina and on angina frequency.   "
78954|NCT02252393|"     This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion     during robotic assisted radical cystectomy in reducing complications in patients with bladder     cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues     and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a     new way for urine to leave the body) is performed. It is not yet known whether intracorporeal     (within the body) or extracorporeal (outside of the body) urinary diversion is a better     method in patients with bladder cancer undergoing robotic assisted radical cystectomy.   "
78955|NCT02252380|"     The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool     for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients     with treatment-refractory symptoms of movement disorders.   "
78956|NCT02252367|"     At present time several preclinical and clinical study have demonstrated the safety and     efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract     symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction.     However, the link between clinical outcomes (symptoms scores), functional activity     (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern     (molecular analyses), has not been previously investigated.      Aim of present study is to assess, for the first time in literature, changes in pressure flow     study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue     remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and     to correlate these data with changes in symptoms scores (IPSS, International Prostatic     Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.   "
78957|NCT02252354|"     The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and     removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral     tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).   "
78958|NCT02252341|"     Effects of N-Acetyl-Cysteine in patients with bipolar depression (primary outcome is Hamilton     Depression Rating Scale) with and without tobacco use disorder and on inflammatory and     oxidative stress biomarkers   "
78959|NCT02252328|"     The trial will compare the effect on disease control and immunosuppression treatment of     adding simvastatin 80mg once daily, over a follow-up and treatment period of 2 years.     Patients will be randomised in a 1:1 fashion to standard treatment with placebo or standard     treatment with the addition of simvastatin (80mg daily). They will be followed at 3 months     intervals for 2 years with a primary end point of mean reduction in corticosteroid dosage at     the 12 month follow-up visit.   "
78990|NCT02251925|"     This study is a prospective randomized controlled trial to compare the pregnancy outcomes of     frozen embryo transfer in natural and hormonal replacement cycles. The study population     consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and     frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran     Iran.   "
78960|NCT02252315|"     Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or     alteration in mental status induced by an external mechanical force to the head. Education     about symptoms and reassurance of a prompt recovery usually results in full recovery.     However, a subgroup appears to have persistent symptoms and disability. This study will     recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable     patient characteristics that can delay or prevent full recovery. A secondary aim is to     determine if providing education in writing or in-person makes a difference.   "
78961|NCT02252302|"     When exposed to air pollution, the asthma symptoms are aggravated and lung function is     impaired. Due to high breathing rates and volumes, physically active individuals are at     particular risk of lung health impairment due to the high breathing rates and volumes.     Greater doses of air pollutants reach deeper areas in the lungs where they can trigger     asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen     even more, allowing the air pollutants to reach even deeper areas of the lung. With this     study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and     lung health in physically active asthmatics.   "
78976|NCT02252107|"     This study examines whether the addition of decitabine to the standard Flu/TBI conditioning     regimen prior to allogeneic stem cell transplantation in poor and very poor risk AML     patients, reduces the risk of recurrence of the disease. Because decitabine has hardly any     side effects, it will likely have little impact on the occurrence of Graft Versus Host     Disease. The investigators are looking for a pre-treatment for transplantation which reduces     the chance of recurrence of the disease without involving severe damage to normal tissues.   "
78977|NCT02252094|"     This study evaluates the use of ultra-protective ventilation, where very low ventilation     volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting     criteria to nurse in the prone position. Half the patients will receive ultra-protective     ventilation support by extracorporeal carbon dioxide removal, while the other half will     receive conventional lung protective ventilation.   "
78978|NCT02252081|"     Chronic kidney disease (CKD) is a major global health problem associated with substantial     costs and resource utilization. Currently, CKD affects more than 500 million people     worldwide. Patients with CKD have unacceptably high mortality rates due to cardiovascular     (CV) causes, which are not entirely explained by traditional CV risk factors. The mortality     rates in advanced CKD are six times higher compared to the Medicare population, with CVD     accounting for the overwhelming majority of deaths. Insulin resistance (IR) is common in CKD     patients and may represent a central link between CKD and the increased CVD risk observed in     this population. Insulin resistance may increase CV risk by impairing and worsening     endothelial function, increasing reactive oxygen species, and exacerbating systemic     inflammation-hence, insulin resistance is considered a non-traditional CV risk factor in     CKD.      Obesity (defined by a body mass index [BMI] of at least 30 kg/m2) is a major public health     problem-the upward trend in obesity prevalence across regions and continents is a worldwide     concern. Obesity increases the risk for cardiovascular disease and death. In the general     population, obesity hastens death by 9.4 years. Obesity is an independent risk factor for     CKD. Besides its contribution to the development of diabetes and hypertension, increased fat     mass may also have a direct impact on kidney function.      In spite of the increasing prevalence of both obesity and CKD, the impact of obesity in the     CKD population is not known, especially in terms of the exaggerated metabolic disturbances     associated with their coexistence. It is highly likely that these two conditions have     profound interactions that exaggerate the severity of the metabolic derangements when they     coexist, particularly in regards to adipokine dysregulation, the risk of insulin     resistance, and downstream effects on vascular health. The current proposal will attempt to     characterize the relative and combined impact of both obesity and CKD on metabolic     disturbances, which may aid in risk stratification and identifying specific targets for     intervention.      The ultimate goal of this proposal is to understand the relative and combined impact of     obesity and CKD on the generation and maintenance of insulin resistance and their impact on     cardiovascular health.      Specific Aim 2: To study the effects of metformin, an AMPK activator, on metabolic     disturbances associated with obesity and moderate CKD.      S.A.2.a: To test if metformin will improve LAR in obese patients with moderate CKD compared     to placebo.      S.A.2.b: To test if metformin will improve markers of systemic inflammation, oxidative     stress, endothelial dysfunction in obese patients with moderate CKD compared to placebo.      S.A.2.c: To test if metformin will improve atherosclerosis markers and reduce clinical CVD     events in obese patients with moderate CKD compared to placebo.      Hypothesis: The investigators hypothesize that the administration of metformin in obese CKD     patients will significantly improve the adipokine profiles-particularly through a reduction     in LAR. Additionally, that it will improve systemic inflammation, oxidative stress and     endothelial function, which may or may not be mediated by changes in adipokines. Finally, the     investigators hypothesize that improvements in these markers of vascular health will     translate into reduced arterial stiffness and less clinical CV events   "
78962|NCT02252289|"     It is increasingly recognised that asthma is not a single disease but that there are many     different phenotypes. Much of the work that we have previously carried out has focussed on     differentiating children with difficult asthma (those whose asthma control improves with     attention to the basics of asthma management such as adherence) from those with severe     therapy resistant asthma (ongoing poor control despite high dose treatment and attention to     the basics. Our collaborators in Basel, Switzerland have demonstrated that serial     measurements of lung function (peak flow) in adults can characterise the severe asthma     phenotype and its stability in adults with asthma. We plan to carry out twice daily peak flow     measurement sin children with asthma using an electronic peak flow meter. We will analyse     peak flow patterns in children with severe therapy resistant asthma (STRA), difficult asthma     (DA) and mild to moderate asthma. We will also investigate the relationship between peak flow     variations and symptoms, recorded in a daily diary and medication use, recorded by an     electronic measuring device which attaches to the child's own inhaler (Smart-inhaler).   "
78963|NCT02252276|"     Objectives: To analyze the effects of proprioceptive and strengthening exercises versus the     same exercises and manual therapy on the recurrent ankle sprain management.      Design: A randomized clinical trial with two intervention groups and triple blind.      Settings: University Hospital.      Participants: Fifty-four patients with previous history of recurrent ankle sprains, regular     sports practice and pain during the physical activity, randomly assigned to experimental or     control group.      Intervention: Control group performed 4 weeks of proprioceptive and strengthening exercises;     experimental group performed 4 weeks of the same exercises combined with manual therapy.      Main Outcomes Measures: Pain, ankle instability, pressure pain threshold (PPT), ankle     eversion strength, and active range of motion in ankle joint. The measures were taken before,     after and one month after the interventions.   "
78964|NCT02252263|"     To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and     identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with     either Lirilumab or Urelumab in subjects with multiple myeloma.   "
78965|NCT02252250|"     To investigates the feasibility, practicability, safety and subjective as well as functional     outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.   "
78966|NCT02252237|"     The purpose of this study is to determine individual susceptibility factors (drug     interactions, genetic factors such as enzyme polymorphism…) to explain wide interindividual     variability towards corticosteroids (prednisone, prednisolone, methylprednisolone) in     children, which could establish a base for therapeutic monitoring.   "
78967|NCT02252224|"     This surveillance is a postmarketing commitment following the marketing authorization for     Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified     by the MFDS under Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical     Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety     assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.   "
78968|NCT02252211|"     The purpose of this study is to find a more effective way of treating solid tumors. This     study will test the safety, bio-distribution, and tumor uptake of a new treatment for cancer     called DS-8895a in patients with advanced solid tumors.   "
78969|NCT02252198|"     Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem     Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF     assay using a gold standard of four cultures   "
78970|NCT02252185|"     The primary objective of this study is to demonstrate that the efficacy and safety of Spine     fusion system manufactured in China is no inferior than imported product.   "
78971|NCT02252172|"     The purpose of this study is to compare the efficacy of daratumumab in combination with     lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of     progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a     blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of     disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).   "
78972|NCT02252159|"     This is a Phase IV, multicenter, non-interventional, non-randomized, prospective,     observational study in an adult population (patients >18 years old) of men and women who have     been diagnosed with clinically overt PV and are being followed in either community or     academic medical centers in the United States who will be enrolled over a 12-month period and     observed for 36 months from the date the last patient is enrolled.   "
78987|NCT02251964|"     This project will address rare immune mediated inflammatory diseases (IMIDs) involving the     lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the     effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary     study parameter is pulmonary function.      The secondary objectives are to explore the application of imaging with radiolabeled RTX as     early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of     life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical     markers.   "
79017|NCT02251574|"     The purpose of this study is to test the effectiveness of two different weight loss diets on     obstructive sleep apnea (OSA) severity.   "
78973|NCT02252146|"     Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in     approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B     Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of     the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the     ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit     ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P     mutation ligand activation of those TLRs results in markedly increased signaling with     subsequent increased cell activation, cell survival, and cell proliferation. The scientific     rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P     mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation     of cells with the mutation and decreases the survival and proliferation of the cell     populations responsible for the propagation of the disease.   "
78974|NCT02252133|"     The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact     lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2     days of wearing of each product.   "
78979|NCT02252068|"     Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk     for continued opioid use and poor treatment outcomes. However, there are currently no     efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate     aims of this trial are the development and testing of a novel integrated cognitive behavioral     treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical     trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We     hypothesize that I-CBT will be a feasible and acceptable treatment that will result in     significant reductions in anxiety and opioid use.   "
78980|NCT02252055|"     To collect evidence of the safety of administering autologous tolerogenic dendritic cells     (ATDC) preparations to living-donor renal transplant recipients in the context of an     international European Union funded consortium aimed at evaluationg cellular immunotherapy in     solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced     by ATDC therapy can evntually be used to reduce the need for conventional immunosuppression     in transplant recipients.   "
78981|NCT02252042|"     This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment     (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and     neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either     pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is     that pembrolizumab treatment prolongs overall survival when compared to standard treatment.   "
78982|NCT02252029|"     This study will establish the duration of excretion of rotavirus vaccine in stool following     vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.   "
78983|NCT02252016|"     This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC)     of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic     Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The     primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir     achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy     (SVR12) will be greater than the reference rate of 40%.   "
78984|NCT02252003|"     In clinical practice with young children, gold standard rating scales used to evaluate the     pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are     self-assessment tools. These scales present however certain limitations: the VAS is not     applicable if the child does not know how to estimate the distances, as young children, or     children with mental retardation. As for FPS-R, it can be frightening for children by the     aspect of faces looking like impersonal masks.      For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face     Legs Activity Cry Consolability (FLACC) can be used, according to the current     recommendations.      We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural     and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide     sample of children. We made the hypothesis that the teddy scale would enable to evaluate the     pain in the same way that the FPS-R, being better accepted and preferred by children.      The first phase of this study will be to develop the teddy scale with a sample of 30 healthy     children from 4 to 11 year-old, having already experienced pain. This stage allows the     validation of the images chosen for the scale, to make sure of their relevance and their     optimal recognition by the children.      The scale will then be validated with a sample of 218 hospitalized children from 2 to 11     years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years     old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to     determine which scale they preferred. Children from 2 to 4 years old will have the teddy     scale; the FLACC will be filled in by parents.      Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that     of the FPS-R scale The validation of the teddy scale will enable to objectify children's     pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to     check the efficiency of these decisions. This teddy scale could be used in current practice     as a replacement of the FPS-R.      Following this study, we planned to set up a second project in which the teddy scale will be     adapted to electronic form (touchpads), to test its adaptability with the children.   "
78985|NCT02251990|"     This is a randomized, parallel-group, placebo-controlled, multi-site, multinational,     double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172)     in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination     [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype     (GT) 1, 4 or 6 infection. The primary hypothesis is that the proportion of participants     receiving grazoprevir/elbasvir FDC in the immediate treatment arm achieving SVR12 (Sustained     Virologic Response 12 weeks after the end of all study therapy) will be superior to the     reference rate of 73%.   "
78991|NCT02251912|"     Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming     alcohol heavily for long periods and are physically and psychologically dependent on alcohol.      Participants: 50 adults with alcohol dependence      Procedures (methods): Oxytocin or placebo will be administered three times a day for the     first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before,     during and at the end of the trial, each subject will undergo evaluations including     breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol     consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at     some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use.     Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks     to evaluate for post-medication safety and efficacy   "
78992|NCT02251899|"     The aim of this study is to determine whether a nurse-managed telephone-based     disease-management intervention can reduce healthcare utilization and improve self-assessed     health status in patients with congestive heart failure.   "
78993|NCT02251886|"     Moxibustion was tested for version of a breech position in singleton pregnancies. The women     were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20     minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic     version was offered for those still in breech position. The randomization was stratified for     primigravida and multiparae separately. The randomization was made with a random number even     and odd numbers indicating moxibustion or not. The randomization result was hidden in a     sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave     informed consent to the study.   "
78994|NCT02251873|"     Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV)     administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the     effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the     short-term safety of this combination   "
78995|NCT02251860|"     ARATA is a prospective, non-interventional, multi-center, observational study in Germany to     evaluate the long-term effectiveness and tolerability of subcutaneously administered     RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis in daily clinical     practice. Participants will be followed over an observation period of up to 2 years after the     initial injection.   "
78997|NCT02251834|"     Stroke is a leading cause of death and functional impairments and stroke risk factors (SRFs)     disproportionately affect Latino populations. In the Hispanic Secondary Stroke Prevention     Initiative (HISSPI) the investigators propose a study using Community Health Workers (CHW)     and mobile technologies using cell phones to reduce the risk for a recurrent stroke among     Latino stroke patients.      The project examines the effectiveness of a combined multilevel intervention consisting of     Community Health Workers (CHW) and mobile based phone technologies in lowering of systolic     blood pressure (SBP) which is the most important risk factor for recurrent stroke.   "
78998|NCT02251821|"     This phase II trial studies how well giving a JAK inhibitor before a donor stem cell     transplant works in treating patients with myelofibrosis that developed without another     condition (primary) or evolved from other bone marrow disorders (secondary). JAK inhibitors     are a class of drugs that may stop the growth of abnormal cells by blocking an enzyme needed     for cell growth. Giving a JAK inhibitor before a donor stem cell transplant may help reduce     symptoms of myelofibrosis such as inflammation and enlargement of the spleen, improve the     patient's general physical condition, and prevent complications from occurring after the     transplant. Infusing healthy stem cells from a donor into the patient may help the patient's     bone marrow work normally and make stem cells, red blood cells, white blood cells, and     platelets. Giving a JAK inhibitor before a donor stem cell transplant may help improve     transplant outcomes in patients with myelofibrosis.   "
78999|NCT02251808|"     This study will be done because the investigators would like to evaluate product satisfaction     of two PINS products (product A, product B) that are to evaluate the effectiveness of     rechargeable and non-rechargeable Deep Brain Stimulation (at baseline visit and at follow-up     visit) and by evaluating their responses to the product satisfaction survey that will be     given to them by a study coordinator.   "
79000|NCT02251795|"     Study to determine the effect of steady-state plasma concentration of Tipranavir/ritonavir     (TPV/r) on platelet aggregation in healthy subjects and investigate the effect of TPV/r at     steady state plasma concentrations on other platelet functions and biomarkers of coagulation     and fibrinolysis.   "
79001|NCT02251782|"     Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden     and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually     screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test)     testing, both have patient-associated barriers that reduce their use. The combination of     bowel preparation and procedure time are barriers to colonoscopy, while stool handling as     part of the sampling protocol reduces FIT usage.      It has been hypothesized and supported by a variety of preference studies that the     availability of a blood-based assay for CRC screening would increase patient participation     and adherence to CRC screening by reducing barriers that prevent participation.      This study is designed to investigate the relative participation in CRC screening in average     risk, screening eligible patients with demonstrated non-adherence to guideline-recommended     screening modalities. Participation with the fecal immunochemical test (FIT) and the     blood-based Epi proColon® test will be examined. Screening eligible average-risk patients     identified as non-adherent by medical record will be eligible for the study. Potential     subjects will be recruited to participate in a study via mailing and/or at a clinic visit.     All study subjects will be enrolled at a clinic visit and will be randomized in two study     arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to     Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be     compared between those that accept and complete the blood test and those that accept and     complete the FIT test. A passive control, usual care arm will comprise subjects meeting     eligibility criteria, but not recruited for or participating in the study.      In conjunction with published data (Johnson et al, 2014), the relative utilization of the     blood test will be compared to the screening participation via FIT. Increased participation     with the Epi proColon blood test could increase screening rates in the non-adherent     population. Additionally, for those testing positive in the trial, the rate of adherence to     colonoscopy will be determined.   "
79002|NCT02251769|"     To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500     mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the     effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir.   "
79018|NCT02251561|"     The purpose of this study is to compare an investigational contact lens care product (FID     109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal     staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked     in the products for 24-48 hours prior to a 2-hour contralateral wear period.   "
79003|NCT02251756|"     Study objective To assess the performance of different application regimens of Actinica® on     protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned     healthy subjects (phototype I to III).      Study centers A total of 20 subjects will be enrolled in 1 site in France.      Methodology This will be a monocentre, randomised, controlled, investigator-blind,     intra-individual comparative clinical investigation.      There will be a total of 6 visits for each subject. Each subject will participate for a     period of maximum 35 days.      Study population Healthy subjects, male or female, at least 18-60 years old, with phototype     I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion     criteria.      The clinical investigation will be conducted in 2 parts.      Part 1 - SPF determination:      To determine the SPF of Actinica® with application of two different amounts (0.8 and 2     mg/cm2).      Part 2 - Sun exposure:      To assess the performance of the different application regimens of Actinica® on protection     from UVR-induced erythema throughout 1 day of sun exposure.   "
79004|NCT02251743|"     Additional treatments with long-term benefit for attention-deficit/hyperactivity disorder     (ADHD) are needed; one of the more promising is neurofeedback (EEG biofeedback), which has     several randomized controlled trials showing significant benefit, but which are inconclusive     because they were not double-blinded; the benefit could have been nonspecific (placebo     response). Because of neurofeedback's labor-intensive cost (1 treatment costing as much as a     month's medication), It is important to know how much specific benefit it yields. This 2-     site placebo-controlled double-blind randomized clinical trial is the first to test for a     specific benefit of neurofeedback with adequate power, the first designed and implemented     collaboratively by experts in neurofeedback, ADHD, and clinical trials, the first to     rigorously monitor quality not only of treatment, but also of placebo and blinding, and the     first to follow up for 2 years to examine enduring effect; the results, whether positive or     negative, will provide evidence for clinical practice and public policy regarding ADHD.   "
79005|NCT02251730|"     To propose a feasibility study of introducing a smoking cessation program in head and neck     cancer patients with planned radiotherapy. The study will feature the feasibility, safety,     and efficacy of a prospective smoking cessation program during head and neck irradiation.   "
79006|NCT02251717|"     This study will evaluate the safety, tolerability, and antiviral efficacy of     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults     with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney     transplant.   "
79007|NCT02251704|"     This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003     studies, enrolling from the same HDSS (health and demographic surveillance system)     populations. The primary objectives are to produce longitudinal estimates of parasite     prevalence in humans, and record malaria control measure usage in areas where EPI-MAL-002 and     EPI-MAL-003 studies will take place.   "
79008|NCT02251691|"     The main objective of this study was to compare the drug compliance in patients after renal     transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.      The rationale for this study is to access the influence of once-daily prolonged-release     tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation     recipients base on the assumption that once-daily dosing regimen may help to improve drug     compliance.   "
79009|NCT02251678|"     Elorac, Inc. is evaluating the effect of Elimune™ capsules on biomarkers C-reactive protein     (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6),     Interleuken-12 (IL-12) in subjects with plaque psoriasis with or without arthritis.      Psoriasis is a chronic inflammatory skin disease with polygenic predisposition combined with     triggering factors such as trauma, inflammation or medication.      Elimune™ is a uniquely formulated prescription dietary supplement for oral administration.     Each capsule contains a proprietary blend of natural ingredients, Vitamin D3, Folic Acid,     Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin,     Glycyrrhizin, and Hesperetin, which share anti-inflammatory activities including the ability     to inhibit tumor necrosis factor-α (TNF-α).   "
79010|NCT02251665|"     A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage,     and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the     National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying     characteristics, stroke features and severity, process for diagnosis and acute treatment, and     long-term outcomes of stroke/TIA patients over the years.   "
79011|NCT02251652|"     Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of     hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore,     use of ingenol mebutate will also be evaluated for potential treatment of subclinical     lesions.   "
79012|NCT02251639|"     The goal of this clinical study is to find out if certain instruments/devices, such as wide     field fluorescence imaging point spectroscopy and/or brush cytology, can help health care     providers find mouth cancer more quickly than a standard oral clinical exam.   "
79013|NCT02251626|"     To test the hypotheses that plasma and intracellular coenzyme Q10 levels will decline after     burn injury and that ubiquinol supplementation will increase plasma and intracellular     coenzyme Q10 levels in burn patients.      To test the hypothesis that ubiquinol supplementation ameliorates mitochondrial     dysfunction/disintegrity and metabolic derangements, and decreases circulating alarmins     (a.k.a. endogenous DAMPs) in burn patients as compared with placebo.   "
79014|NCT02251613|"     The purpose of this study is to evaluate the effectiveness and safety of Olopatadine     Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05%     in a population of healthy, adult Japanese patients (20 years of age or older) with a history     of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to     receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic     solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with     Japanese cedar pollen will be performed.   "
79015|NCT02251600|"     Study to characterize the single-state and steady-state dosing of oral deflazacort in     pediatric and adolescents subjects.   "
79016|NCT02251587|"     The purpose of this study is to learn if a weight loss program especially designed to address     food insecurity is more effective compared to a standard weight loss program.   "
79020|NCT02251535|"     Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in     the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs.     rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based     motion capture evaluation. How do different levels of intra-operatively observed femoral     rollback correlate to postoperative kinematics under weight bearing conditions? Does the     modified design of the Attune Knee System influence the extent of the femoral rollback     compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12     months follow up or is it reduced by, for example, remodelling of the posterior cruciate     ligament?   "
79021|NCT02251522|"     It has been noted that patients dramatically overestimate their functional ability early     after surgery. Despite use of assistive devices increasing and functional testing scores     decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome     questionnaires will be administered and functional testing will be conducted on all patients     to capture these changes.   "
79022|NCT02251509|"     This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart     rate control in patients with atrial fibrillation and a rapid ventricular rate.   "
79023|NCT02251496|"     At least one fifth of patients in European hospitals are malnourished. Malnutrition is     associated with negative consequences, including higher rates of complications, longer     hospital stay, impaired wound healing and increased mortality with consequent effects on     costs of healthcare. Evidence suggests that there may be benefits to some malnourished     patients from receiving oral nutrition supplements in the short-term but it is not known     whether these benefits can be sustained and indeed whether similar benefits may be achieved     using food-based interventions of lower cost. The overall objective of the study is to     compare two nutritional interventions among malnourished patients with COPD (n=200); oral     nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during     hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is     weight change. Secondary endpoints include forced expiratory volume in one second, forced     vital capacity, six-minute walk distance, hand-grip strength, health related quality of life,     length of hospital stay, energy- and protein intake, readmissions to the hospital and acute     exacerbation. No studies are available comparing the supply of ONS to malnourished patients     with COPD compared with the provision of regular food (in-between meals snacks). The results     of the study will provide important information that might improve nutrition care in the     hospital setting as well as after discharge from the hospital   "
79024|NCT02251483|"     The primary objective of this study is to determine whether giving SBI as a medical food     starting with maintenance of health in the management of chronic loose and frequent stools in     IBS-D subjects with SIBO after successful treatment with rifaximin can lead to more prolonged     duration of benefit and delay symptom recurrence. SBI is the main ingredient in EnteraGam™,     an orally administered prescription medical food for the dietary management of patients with     enteropathy or chronic loose or frequent stools, including patients with IBS-D.   "
79025|NCT02251470|"     BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in     rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo     Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger     trials are necessary to verify these positive effects after discharge from the hospital.      AIM: This study aims to prepare and optimize a phase III trial which compares the effects of     two HBE programs for stroke patients.      METHODS: A pilot study with randomized control design and repeated measures over three-months     will be conducted. Twenty elderly stroke patients will be randomly allocated to an     experimental group (EG) and a control group (CG). All participants will receive an     introduction to a HBE program by an individual mentoring over 6 weeks. During the following 6     weeks the participants perform the HBE on their own. The EG will perform a balance exercise     program using the WII, the CG will perform a balance exercise program without technical     support.      Recruiting potential, the participants' acceptance of the intervention and economic aspects     will be examined. Additionally, basic information about sensitivity of change and potential     effect sizes regarding the proposed instruments to measure mobility are expected.   "
79026|NCT02251457|"     The purpose of this study is to gather preliminary data to determine if ranolazine is a safe     and effective treatment for the symptoms of myotonia congenital, paramyotonia congenita, and     myotonic dystrophy type 1. The duration of the study is 5 weeks.   "
79027|NCT02251444|"     This study investigates effects of a multidisciplinary rehabilitation program or physical     therapy in patients with chronic low back pain on emotion regulation and coping behaviour.      Hypothesis: Significant differences of negative emotions pre and post treatment and between     groups after intervention.      Standardised questionnaires are used for investigation   "
79028|NCT02251431|"     Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with     impaired relaxation of the heart mildly reduced kidney filtration function (Type 4     cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of     treatment with exenatide extended-release injections versus placebo. on a cardiac biomarker     blood test score, cardiac fibrosis seen on magnetic resonance scanning, cardiac strain     identified by ultrasonography and strain rate imaging, and a kidney urine biomarker score.   "
79038|NCT02251301|"     The purpose of this study is to investigate whether combining interval training with skim     milk supplementation will result in improved glucose control and markers of cardiovascular     health in people with type 2 diabetes. Participants will complete supervised interval     training three times a week over a 12 week training period while consuming skim-milk,     whey/casein protein drink, or a placebo beverage that does not contain any calories or     vitamins/minerals immediately and 1 hour after each training session. After twelve weeks     participants will repeat baseline tests to examine any effects of the intervention on their     glucose control, fitness, blood vessel function, body composition, and blood markers of     inflammation.   "
79052|NCT02251119|"     The objective of the study was to determine if the co-administration of loperamide (LOP) with     tipranavir (TPV), ritonavir (RTV), or TPV plus RTV (TPV/r) caused a clinically significant     change in the respiratory response to carbon dioxide (CO2), defined as a 10% decrease in the     area under the pharmacodynamic effect/time curve or at least a 25% decrease in at least one     pharmacodynamic time point.   "
79029|NCT02251418|"     Introduction:      Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain,     discomfort and reduced quality of life. The development of foot ulcers places the patients at     a risk of amputation. In the Danish Health Care System a substantial effort is done to     prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is     ongoing. The goal is to optimize wound healing and prevent amputations.      Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates     low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A     small amount of energy will be deposited in the tissue when shockwaves are applied. This     stimulates the cells to produce substances that generate new vessels. No side effects to ESWT     have been shown.      Purpose:      The investigators want to test whether shockwave therapy can improve wound healing among     diabetic patients with foot ulcers.      Hypothesis:      The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases     blood flow, reduces pain, and has no side effects.      Method:      Patients who are interested in participation will be included in the study and divided by     randomization into two groups of equal size. The first group is treated with ESWT in     combination with regular guideline treatment. The second group is set up as control group and     will only receive regular guideline treatment. The participants are examined in different     ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to     measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for     infection at every consultation, and a swab sample will be collected at enrollment. The size     of the ulcers are measured and photographed each time. The investigators will count how many     foot ulcers that are completely healed during the test period and measure the sizes of the     remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer.     Data concerning participants' co morbidities and use of analgesic drugs are obtained from the     patient journal and by patient interview.      Significance:      ESWT should be considered a supplement to existing clinical guidelines in wound management if     shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the     heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of     amputations among diabetic patients will decline by implementing new treatment options for     the diabetic foot.   "
79030|NCT02251405|"     One source of melamine exposure in the modern life is from the use of melamine tableware.     This study examines whether the use of stainless steel containers can decrease melamine     exposure in the daily life. The investigators hypothesize that, compared to those without use     of stainless steel containers, university student volunteers with use of stainless steel     containers excrete significantly lower melamine levels in urine.   "
79031|NCT02251392|"     This study aims to evaluate therapeutics interventions in radiodermatitis in patients with     breast or head and neck cancer. The data collect is going to begin after determining the     better dose in a dose-response curve that is being conduct now in the same institution. To     evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group     (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse     Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).   "
79069|NCT02250898|"     The aims of this study are to determine the effectiveness of myofascial massage specific to     the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among     patients who have undergone a mastectomy or other breast surgery compared to a control group     receiving global relaxation massages.   "
79032|NCT02251379|"     This study evaluates the effects of adding on an environmental home intervention to standard     asthma medication management on controller medication requirements among children and     adolescents with asthma. The investigators hypothesize that the addition of an     individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based     controller medication will result in less controller medication requirement and allergic     inflammation than controller medication alone among urban asthmatic children.   "
79033|NCT02251366|"     Intravitreal delivery of anti-vascular endothelial growth factor (VEGF) drugs has     revolutionized the management of neovascular age-related macular degeneration (NVAMD).     However, the requirement for near monthly administration of therapy coupled with the growing     number of patients needing treatment has become a universal challenge in efficient delivery     of care for retina physicians. While many retina practices have both increased the size of     their staffs to accommodate the growing patient population and increased efficiency with the     aid of digital photography, patient encounter times in clinic continue to increase, often     spanning 2-4 hours. While maintaining the highest level of patient care, a streamlined     alternative in the evaluation of patients with NVAMD to determine whether intravitreal     therapy with an anti-VEGF agent is indicated at a particular office visit would be desirable.      This multi-satellite, prospective, randomized pilot study will compare standard-of-care,     physician- based retinal evaluation, defined as retinal examination by a physician and     standard imaging with optical coherence tomography (OCT) and optional fluorescein angiography     (FA), versus physician-guided diagnostic evaluation, defined as standard imaging with OCT and     optional FA without retinal examination by a physician in the management of NVAMD with     anti-VEGF therapy. Outcomes for this study are aimed primarily at demonstrating that the     physician-guided diagnostic approach to managing patients with NVAMD is not inferior to the     physician-based retinal evaluation based on measures such as a change from baseline in visual     acuity and in central subfield thickness (CSF) on OCT. Other outcomes to be assessed in this     study are length of visit times, numbers of intravitreal injections of anti-VEGF agents     administered, numbers of diagnostic tests performed to determine whether treatment should be     given at each visit, and frequency of retinal examinations performed for each participating     patient in each cohort. Perceptions of quality of vision and patient satisfaction will be     captured by interviews with patients following each clinic visit; clinical impressions of     physicians will be captured by a brief physician survey. Finally, the feasibility of     recruiting patients, as measured by how many eligible patients are seen at each Wilmer     satellite, how many patients agree to be randomized, how many patients follow-up, and the     attrition rates at the 4 and 8-month outcome visits will be assessed.   "
79034|NCT02251353|"     The number of intervention performed for metastatic breast cancer has dramatically increased     over the past 2 decades. Hepatectomy and pulmonary resection for stage IV colorectal cancer     is now considered the standard of care for resectable patients with isolated hepatic and/or     pulmonary disease and acceptable performance status. However, the indications for resection /     intervention of breast cancer origin metastases are not as clearly defined. The aim of this     study to focus on emerging data for the intervention (resection and/or radiofrequency     ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic     radiosurgery) of breast cancer metastatic disease to the lung and liver, with a focus on     indications for resection / intervention.   "
79035|NCT02251340|"     The objectives of this project are to increase families' understanding of eczema and improve     eczema management in the primary care setting. We have created an Eczema Care Plan similar     to those used in the management of asthma. It gives specific instructions about medications,     bathing and moisturizing, as well as when to seek further treatment. We will conduct a     randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period.     Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and     (3) increase parental knowledge and confidence about eczema management. We also plan to track     provider uptake and documentation of the plan and elicit feedback from parents and providers     on the utility and feasibility of the plan.   "
79036|NCT02251327|"     Consenting adults will be interviewed for demographic and medical information, and then will     be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be     tested using conventional and investigational diagnostic tests for tuberculosis.   "
79037|NCT02251314|"     Despite recent advances in cancer treatment, little impact has been made on curing as opposed     to controlling cancers over the last several decades. Part of the problem is that     investigators have an incomplete understanding of how tumours behave as they evolve and in     response to treatment. In this trial, the investigators hope to better understand the     evolution of BRAF melanoma in response to drugs a patient may have received such as     vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours     evolve resistance to these drugs and whether this can be predicted through blood tests, in     particular of the circulating tumour DNA.   "
79039|NCT02251288|"     A phase I prospective, randomized study in healthy adult subjects at a single center. Adult     subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as     subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group     1), 12 weeks (Group 2), or 24 weeks (Group 3), or to be in an observational group (Group 4)     which will not be scheduled for a booster dose but may serve as a roll-over group for     subjects who withdraw prior to the second vaccination but agree to remain in follow-up. A     fifth group will receive two intramuscular doses of adjuvanted H7N9 pIIV separated by four     weeks.   "
79040|NCT02251275|"     The purpose of the study is to evaluate and describe the long term safety of tolvaptan in     patients with autosomal dominant polycystic kidney disease (ADPKD   "
79041|NCT02251262|"     With aging of the general population and broadening indications, the number of pacemaker     recipients is steadily increasing. The incidence of infections of the implanted material, a     dreaded major complication, is also rising. The diagnosis is evident in presence of an     abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to     the lead. On the other hand, a proportion of patients present with less specific clinical     manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious     disorder of unknown origin despite detailed investigations. Without proof of lead infection,     removal of the system without confirmation of its infection is usually proposed, despite the     known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive     culture of the leads implies that the leads were involved in the infectious process. In     recent years, 18FDG-PET-CT scan has made promising contributions in different areas including     imaging to detect infection at different organ sites. Absence of hyperfixation of the lead,     identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system     infection.      The extraction of intracardiac implanted material, when it is indicated by the current     standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients,     even when they did not receive antibiotics before extraction.      The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current     strategy may avoid or reduce these false-positives.      Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to     avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive     value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at     providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its     sensitivity.      For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with     suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit;     secondarily, an intervention for the extraction of the intra-cardiac material, under general     anesthesia, will be practiced and then a bacteriological culture for extracted material will     be required.      The end of study visit is complete the last day of material extraction. The follow up will     last 2 to 7 days.   "
79070|NCT02250885|"     Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and     gastrointestinal and pancreatic neuroendocrine tumors.   "
79042|NCT02251249|"     Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial     infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric     emptying time is observed during STEMI, limiting the use of morphine and encourage the use of     prokinetic agents can be a first answer to optimize coronary angioplasty environment.      Investigators propose a study to assess the gastric emptying times at the acute phase of     myocardial infarction using a validated paracetamol absorption test. The STEMI group will be     compared to in one hand, itself with measures performed 72 hours±12h after the event onset;     and on the other hand, to a stable patient group referred for angioplasty for angina or     non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient     group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by     VerifyNow® test and correlated to gastric emptying times.   "
79043|NCT02251236|"     The project will have two tracks, one for participants who are currently taking     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir     alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for     participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track     B).      Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF)     STR** (if available) for 24 weeks.      *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and     300 mg of tenofovir disoproxil fumarate.      **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine,     and 10 mg of tenofovir alafenamide fumarate.   "
79044|NCT02251223|"     Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) /     ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs.     TPV 250 mg/RTV 200 mg on the steady-state pharmacokinetics of zidovudine, lamivudine,     stavudine, didanosine, abacavir, nevirapine and efavirenz at approved doses. The three     treatment groups will be enrolled sequentially starting with the highest tipranavir dosage     group first and ending with the lowest tipranavir dosage group.      Secondary: A) To assess the effects of zidovudine, lamivudine, stavudine, didanosine,     abacavir, nevirapine, and efavirenz on the pharmacokinetics of tipranavir/ritonavir compared     to historical controls.      B) To assess the safety of three tipranavir/ritonavir combinations when used in combination     with protocol defined antiretrovirals.   "
79045|NCT02251210|"     To investigate efficacy and safety of 3 doses of BIIL 284 BS in active rheumatoid arthritis     (RA) and determine the dose with most positive efficacy / safety ratio. Pharmacokinetic     profile will be also obtained.   "
79046|NCT02251197|"     The objective of this study is to assess the safety, tolerability and pharmacokinetic     characteristics of BIII 890 after intravenous infusion in acute ischemic stroke patients.   "
79047|NCT02251184|"     Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole     administered as the immediate release formulation plus aspirin, under conditions of reduced     stomach acidity.   "
79048|NCT02251171|"     Study to determine the effects of steady-state Tipranavir (TPV) / Ritonavir (RTV)     (500mg/200mg bid) on the single-dose pharmacokinetics of Rifabutin (RFB) and to determine the     effects of single-dose RFB on the steady-state pharmacokinetics of TPV 500mg (co-administered     with RTV 200mg)   "
79049|NCT02251158|"     Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r)     oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to     investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food     versus without food.   "
79050|NCT02251145|"     Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500     mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of     tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the     pharmacokinetics of tipranavir/ritonavir.   "
79051|NCT02251132|"     The objective of this study is to establish the tipranavir-ritonavir steady-state     dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the     effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to     establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally, the     short-term safety and tolerance of this drug combination will be evaluated.   "
79053|NCT02251106|"     A recent province-wide survey (Alberta, Canada) suggests that clinicians' beliefs about soft     lumbar bracing for low back pain (LBP) vary substantially. Approximately 50% of clinicians     (MDs, DCs, PTs) find back braces useful for acute back pain while the remaining half report     that bracing causes muscle atrophy. While previous studies suggest bracing for acute low back     conditions can reduce pain and does not cause atrophy, no prior study has assessed back     function after bracing using self-reported and objective measures within the same cohort.      PURPOSE:      To assess both self-reported and objective measures of spine function before, and after, use     of an inelastic lumbar brace over a two week period.      STUDY DESIGN:      Before-After Design      OUTCOME MEASURES:      Self-reported spine function, spinal stiffness and muscle endurance.      METHODS:      Three groups were studied: asymptomatics who did not wear a brace (-LBP/-Brace),     asymptomatics who were braced (-LBP/+Brace) and acute LBP subjects who were braced     (+LBP/+Brace). Both groups of braced subjects (-LBP/+Brace; +LBP/+Brace) were instructed to     wear the brace continually for 2 weeks with the exception of bedroom & bathroom activities.     Before and after the 2 week period, 3 measures of spine function were performed: spinal     stiffness via motorized indentation of the L3 spinous process, a modified Sorensen test     (timed lumbar extension against gravity), and the Oswestry Disability Index (ODI). Unbraced     (-LBP/-Brace) subjects were studied over the same time with the same measures. Repeated     measures analyses of variance were conducted for all three outcomes with a significance level     of 0.05.   "
79109|NCT02250378|"     This pilot clinical trial studies the side effects and how well stereotactic radiosurgery     followed by wedge resection works in treating patients with early stage non-small cell lung     cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic     radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation     therapy that delivers a single, high dose of radiation directly to the tumor and may kill     more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive     type of surgery for removal of the tumor and a small amount of normal tissue around it.     Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option     for patients who cannot receive standard treatment with lobectomy.   "
79054|NCT02251093|"     The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of     Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus     rhamnosus Lcr35® is a live bacterium administered with its culture medium.      It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking:     0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects     (lowering the vaginal pH).      A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus     rhamnosus Lcr35®:        -  to establish itself in the vaginal epithelium, along with the durability of this          establishment.        -  and to inhibit the growth of pathogenic organisms responsible for causing bacterial          vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida          albicans), by synthesising various microbicidal substances.      This research follows on from the Candiflore observational study in which 514 patients were     monitored and which demonstrated a clearly positive result in favour of the use of vaginal     Lcr Regenerans® for preventing recurrences of VVC.      The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in     the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with     recurrent episodes, in view of obtaining a marketing authorisation.   "
79055|NCT02251080|"     Attention Deficit/Hyperactivity Disorder (ADHD) is a common condition in young adults. There     are many safe oral therapies that require daily use to be effective. Because frequent     follow-up visits have been shown to increase adherence to medication, we will determine if     adherence to oral therapy for ADHD will improve with an intervention involving weekly     internet-based contact without an office visit.      The primary aim is to determine the effectiveness of an Internet-based survey in improving     adherence to therapy for ADHD. Subjects in this study will be either receive a weekly     Internet-based survey assessing the prescribed medication and their ADHD, or to receive     standard-of-care therapy in which they will take their medication. The following hypothesis     is to be tested: A weekly Internet survey will promote improved adherence to oral ADHD     medications.   "
79056|NCT02251067|"     The purpose of this study is to determine whether VPI-2690B Injection is effective in the     treatment of diabetic nephropathy.   "
79057|NCT02251054|"     This study compares the efficacy of embedding avatars into an online self-management program     that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy,     and adherence versus the same program without avatars   "
79058|NCT02251041|"     The purpose of this study is to establish the effectiveness of the combined drug approach     (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta,     C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce     ischemia-reperfusion injury during liver transplantation in eligible recipients.   "
79059|NCT02251028|"     The purpose of this study is to determine whether a specifically tailored value-based     cognitive behavioural therapy program (V-CBT) is able to prevent the development of     persistent disability, pain, and psychological distress if delivered within the first three     months after a whiplash injury.   "
79060|NCT02251015|"     To investigate the effects of the use of occlusal splint over postural balance in individuals     with signs and symptoms of temporomandibular disorder. The research group consists of 49     patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old,     both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and     magnetic resonance imaging of the temporomandibular joints. The research is a randomized,     controlled, prospective clinical study with intervention. Postural equilibrium will be     evaluated by means of a force plate. In the randomization, the splinted group was under an     occlusal-stability criterion as well as advised under therapeutic exercises while the control     group got only orientation about therapeutic exercises. After 12 weeks, the groups were     re-evaluated. The results will be analyzed by categorical data using absolute and relative     frequencies as well as continuous data using average, median, standard deviation, 25 and 75     percentiles, besides minimum and maximum values; comparison between the times by     non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of     0.05.   "
79061|NCT02251002|"     The purpose of this study is to determine whether there is a quantitative relationship     between brain processes seen by a MRI and visual deficits caused by mild to moderate     traumatic brain injuries (mTBI).   "
79062|NCT02250989|"     The objective of this study is to investigative the influence of different levels of     glycaemia or insulinemia in vascular endothelium in ischemia/reperfusion lesion after     myocardial infarction   "
79063|NCT02250976|"     To develop combination product of micronized fenofibrate plus pitavastatin, we would like to     evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized     fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen     cap.160mg(micronized fenofibrate160mg) and Livaro tab. 2mg(pitavastatin Ca 2mg) under fed     condition in healthy male volunteers.   "
79065|NCT02250950|"     The current study involves conducting an intervention based on self-determination theory     (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse     sample. It is expected that this intervention will successfully increase physical activity in     participants.   "
79066|NCT02250937|"     If you are reading and signing this form on behalf of a potential participant, please note:     Any time the words you, your, I, or me appear, it is meant to apply to the potential     participant.      The goal of this clinical research study is to compare how well two different schedules of     giving busulfan with fludarabine and cladribine before a stem cell transplant in patients     with AML or MDS may help to control the disease. The safety of this drug combination will     also be studied.   "
79067|NCT02250924|"     This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial     of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure.     Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times     daily for 30 minutes starting the day following surgery until discharge or 24 hours after     attainment of the primary endpoint.   "
79068|NCT02250911|"     The purpose of this study is to gather information on how easy it is to implement the     workshop, as well as whether individuals find this workshop helpful. In this study,     participants will be assigned at random to one of the two study groups. Based on the     information we obtain, we hope to develop an easily accessible support service for     caregivers.   "
79071|NCT02250872|"     Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute     kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are     well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide     (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the     potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI.     This is a single-center, randomized, double-blind, parallel-group, placebo-controlled,     prospective study to investigate the renoprotective effect of DPP4 inhibitor on     cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will     be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will     take study drugs for 8 days starting from one day before cisplatin treatment. Serum     creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days     after cisplatin treatment.   "
79072|NCT02250859|"     The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101     4% foam product in male and female some of which are with acne   "
79073|NCT02250846|"     The purpose of this study is to determine whether EGFR-TKI can control the development of     intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain     metastases, and the difference in progression free survival between exon 19 and exon 21     mutations.   "
79074|NCT02250833|"     A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the     pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration     telmisartan and s-amlodipine in health volunteers.   "
79075|NCT02250820|"     The study will examine the quality of two sedation techniques (dexmedetomidine and     pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic     echocardiography (TTE).   "
79076|NCT02250807|"     The purpose of this study is to show superiority of simeprevir (SMV) in combination with     sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite     of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in     combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in     study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior     relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in     this study.   "
79077|NCT02250794|"     The purpose of this study is to test whether a combination of two pills commonly used to     treat outpatient diabetes called metformin and sitagliptin (januvia) could provide successful     control of blood sugar levels in patients with type 2 diabetes during hospitalization for the     treatment of a general medical condition. Both metformin and sitagliptin are currently     approved by the Food and Drug Administration for the treatment of type 2 diabetes, but little     experience exists for their use in hospitalized patients. The current standard practice is to     use insulin injections to control blood sugar in hospitalized patients with type 2 diabetes.     This study will compare the use of metformin tablets twice per day along with sitagliptin     tablets once per day with daily insulin injections in patients with type 2 diabetes during     hospitalization, and will study how well the blood sugar levels are controlled.   "
79078|NCT02250781|"     This phase I trial studies the side effects and best dose of Oral ONC201 in treating patients     with advanced solid tumors. Oral ONC201 may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
79079|NCT02250768|"     The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage     Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with     repeated implantation failure (RIF)   "
79087|NCT02250664|"     This study will examine extended exposure to cigarettes varying in nicotine content among     opioid abusers. Prevalence of smoking among opioid-dependent adults far exceeds that of the     general US adult population. Opioid-dependent smokers are also at elevated risk for     smoking-related adverse health effects. Studies testing an innovative regulatory strategy of     reducing the nicotine content of cigarettes to a non-addictive level have shown promising     beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased     cessation) in the general population of smokers. However, these studies have uniformly     excluded vulnerable populations like opioid abusers who may respond differently considering     their greater vulnerability to smoking and nicotine dependence. Thus, little is known     scientifically about how this highly vulnerable subgroup of smokers might respond to a     nicotine reduction policy. This project is designed to address that substantial knowledge     gap.   "
79080|NCT02250755|"     This study therefore aims to assess current treatment recommended by scientific societies [     6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain     metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg     [ 14 ] . Sequences infusion different from one center to the other made : some use the     infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to     use one or the other of these sequences.      No examination is added for the purposes of protocol. Indications for MRI and the number and     timing of MRI checks under this protocol are consistent with what is done in practice . The     used type of gadolinium and the injected dose will be identical for both sequences infusion .     The assessment shall not in any case the contrast but the interpretation of the sequence     itself. Special procedures monitoring implemented embodiment correspond to the two sequences     instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and MRI     of the first control , in order to compare their effectiveness   "
79081|NCT02250742|"     The study will establish data on the function of trunk muscles in healthy and low back pain     patient's pre and post dry needling treatment. This will help in understanding the underlying     mechanism of this treatment and reveal the effect of dry needling on muscle performance.      Study hypothesis is that an improvement of back muscle function following dry needling     procedure will be found.   "
79110|NCT02250365|"     This study evaluates the effect of electrical somatosensory stimulation (ESS) on the     restoration of upper limb functioning in acute stroke patients. The effect will be measured     at the end of the intervention and six months post-stroke. We expect that ESS facilitates the     restoration of upper limb functioning and the brain reorganization following stroke.   "
80608|NCT02231021|"     This study evaluate the efficacy and safety of alogliptin and pioglitazone combination     therapy in comparison with either alogliptin or pioglitazone on glucose control in the     metformin-treated type 2 diabetic patients in Korea.   "
79082|NCT02250729|"     The main objective of this study is to compare pholcodine exposure in patients having     presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine     exposure in matched anaesthetised patients with injection of NMBA, who did not present with     an anaphylactic reaction (controls).      The secondary objectives of the study are:        -  To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the          case and control groups.        -  To study the concordance between exposure to pholcodine in cases and controls, by means          of a patient self-questionnaire on the one hand and, on the other hand, by a          computerized drug history, supplemented where relevant by the drug master file.        -  To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.        -  To study the association between exposure to pholcodine and the presence/levels of          pholcodine-specific IgE, reflecting sensitisation to pholcodine.        -  To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine          in case patients allergic to (at least) one NMBA.   "
79083|NCT02250716|"     Based on the high incidence of cervical cancer and high grade dysplasia and increased     progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the     effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month     cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for     HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen     Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have     had a colposcopic biopsy for persistent LSIL as per standard of care.   "
79084|NCT02250703|"     BACKGROUND INFORMATION AND RATIONALE      Pediatric patients scheduled for dental procedures under general anesthesia can have     significant anxiety before the procedure. They are commonly pre medicated to minimize     distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose     is more widely used for this purpose . However the commonly used maximum dose is up to 15mg.     It also has many limitations such as paradoxical reaction, increased incidence of emergence     delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been     used an effective and safe alternative premedication to oral midazolam in children. At a dose     of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation     in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as     providing analgesia and facilitating smooth emergence from anesthesia.      The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative     as premedication to oral midazolam in children weighing more than 20kg undergoing general     anesthesia for dental rehabilitation.   "
79085|NCT02250690|"     The aims of the present study was to analyze the effect of consecutive sessions of     Transcranial direct current stimulation associated to kinesiotherapy about gait performance     of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by     means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min)     and stride length (m). The secondary outcome is motor cortex excitability which is analyzed     by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor     evoked potential amplitude (MEP) and rest motor threshold (rMT).   "
79086|NCT02250677|"     Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of     cardio-vascular diseases (CVD). The use of statins has increased markedly and it is now one     of the most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a     daily basis, 40 % of these are taking the medication without having any other risk factors     for CVD than elevated blood-cholesterol i.e. they are in primary prevention.      Statins are not without side effects and studies have shown that there is an elevated risk of     developing diabetes when taking statins. This has led to an increased debate about the use of     statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent     one event of CVD, it is necessary to treat 200 people for 3-5 years. These data suggest that     more conservative use of statins to prevent CVD in otherwise healthy individuals at low risk     for future CVD may be warranted.      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially     can prevent a physically active lifestyle. The biomedical background of these side effects is     not fully elucidated but it has been shown that there is a link to decreasing levels of an     important enzyme, Q10, which plays a role in muscle energy metabolism.      Hypothesis      The overarching research question is: why does statin treatment cause muscle pain? Does     statin treatment impair (or even prohibit) physical exercise training? Furthermore we would     like to answer the following questions:      a Does statin treatment impair (or even prohibit) physical exercise training?      b Does statin treatment cause:        -  Decreased muscle strength?        -  Skeletal muscle inflammation?        -  Decreased mitochondrial respiratory function?      c Abnormal glucose homeostasis?   "
79088|NCT02250651|"     This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in     patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month     treatment period with an 8-month extended follow-up.   "
79090|NCT02250625|"     To obtain sufficient specimens and correlating clinical data from a well-controlled     prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays,     and to establish a collection of specimens that will support future assay discovery and     validation efforts.   "
79091|NCT02250612|"     The purpose of this double-masked, randomized, controlled study is to assess the safety and     ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops     compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated     intraocular pressure.   "
79092|NCT02250599|"     The present study will be a randomized, control, multicenter phase II study of metastatic     nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and     carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population     consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or     chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be     evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H&N35 are     used to measure PRO outcome for this study.   "
79690|NCT02242825|"     The primary objective is to evaluate the effect of the treatment with Micardis® or     MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® /     MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c)     in patients with essential hypertension and diabetes mellitus   "
79093|NCT02250586|"     BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem     gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have     devastating effects on the economy, health and relationship, both for the problem gambler and     their concerned significant other (CSO). No empirically supported program exists for the CSOs     of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program     aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles     from cognitive behavioral therapy and motivational interviewing. In order to benefit as many     CSOs as possible, the program will be delivered via the Internet with therapist support via     email and telephone.      METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A     cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem     gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules     over 10 weeks in a secure online environment, and receive support via text messages and over     telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline     3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to     seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship     satisfaction and quality of life.      HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction     in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's     anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and     money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's     relationship satisfaction with the problem gambler.   "
79094|NCT02250573|"     The main objectives of this study were to investigate the safety and efficacy of     Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and     achieve haemostasis in subjects with haemophilia B undergoing surgery.   "
79095|NCT02250560|"     The main objective of the study is to investigate the safety and efficacy of Replenine®-VF     administered by continuous infusion in appropriate dosage to prevent bleeding and achieve     haemostasis in patients with haemophilia B undergoing major surgery.   "
79096|NCT02250547|"     Evaluate the percentage of patients optimized at least once every month by the SonR automatic     optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus     rhythm   "
79097|NCT02250534|"     This study will examine extended exposure to cigarettes varying in nicotine content among     disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine     dependence, and using high nicotine yield cigarettes and are also at significantly increased     risk for smoking-related adverse health consequences, including cervical cancer, thrombosis     related to hormone-based contraception, infertility, and early menopause. Studies testing an     innovative regulatory strategy of reducing the nicotine content of cigarettes to a     non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced     toxicant exposure, and increased cessation) in the general population of smokers. However,     these studies have uniformly excluded vulnerable populations like disadvantaged worn who may     respond differently considering their greater vulnerability to smoking and nicotine     dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of     smokers might respond to a nicotine reduction policy. This project is designed to address     that substantial knowledge gap.   "
79098|NCT02250521|"     Our primary aim for the study is to measure intubation success rate on first attempt in     management of the difficult airway, which could possibly allow us to determine at what direct     laryngoscopic grade it becomes advantageous to use the McGRATH® MAC video laryngoscope.   "
79099|NCT02250508|"     The main objectives of the study were        -  to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of          vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and          Factor VIII assays.        -  to compare the clinical tolerance and safety of these two treatments after single IV          infusions in subjects with VWD.   "
79100|NCT02250495|"     The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara     Therapeutic System in the treatment of hypertension   "
79101|NCT02250482|"     The main objective of the study is to investigate the safety and efficacy of Optivate®,     administered in appropriate dosage to present bleeding and achieve haemostasis in patients     with Haemophilia A undergoing surgery.   "
79102|NCT02250469|"     12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in     patient experiences with two different types of Spinal Cord Stimulator devices which are     routinely used to treat chronic pain.   "
79103|NCT02250456|"     Turner syndrome is a genetic condition, rare, due to the total or partial absence of one X     chromosome, affecting 1/2500 newborn female. It combines almost constantly short stature and     ovarian failure with infertility.      Other anomalies are inconstant: morphological characteristics of varying intensity,     associated malformations, and increased risk of acquired diseases ...      The prognosis of patients reaching the Turner Syndrome is linked to cardiovascular     complications (congenital heart disease, dilatation of the ascending aorta with risk of     dissection or rupture of aneurysm), causing early mortality with reduction of life expectancy     of at least 10 years.      For these reasons, screening for heart disease and dilatation of the ascending aorta is     established and is intended to prevent the complications associated with medical treatment     and / or surgery to increase life expectancy and reduce the co-morbidities.      On the vascular level, the recommendations other than those relating to the monitoring of the     diameter of the ascending aorta include research of renal artery stenosis by doppler     ultrasound if the patient is hypertensive and looking for lymphedema.      However, other arterial lesions were described in the literature, outside of the aneurysm of     the ascending aorta. These peripheral arterial lesions can also be life and / or functional     prognosis of the patient. Ascending aorta dilation seems not to be exclusive in Turner     syndrome.      In addition, specific vascular lesions outside the affected artery are described: hepatic     cirrhosis by vascular depletion, lymphedema and varicose veins. The prevalence of venous or     lymphatic disease is unknown.      A single-center review of 9 cases of patients followed at the University Hospital of     Strasbourg showed the presence of vascular lesions discovered incidentally during assessments     performed for reasons other than cardiovascular screening: cystic lymphangioma, internal     carotid aneurysm, agenesis of the inferior vena cava, early varicose veins, embryonic     cerebral artery, etc ... None of these patients showed any dilatation of the ascending aorta     or heart disease. Peripheral vascular abnormalities in this patient group are exclusive.      In this study, we seek to demonstrate that arterial disease in Turner syndrome involve the     entire arterial territory and is not confined to the ascending aorta. Screening for arterial     lesions should be performed on the entire arterial vascular tree and regularly in the course     of time, especially as the presence of cardiovascular risk factors increases with the age of     these patients.      The venous and lymphatic vascular damage in the literature and in our series of cases in     University Hospital of Strasbourg description should also lead to the detection of these     lesions.      These vascular complications can be alone responsible for the reduction in life expectancy or     responsible for serious morbidity. Improved screening of associated vascular lesions is     necessary to enable the best prevention of cardiovascular complications.      It is also to establish the prevalence of vascular anomalies, whether arterial, venous or     lymphatic, to better understand the disease and its management. By collecting systematically     karyotype leading to diagnosis, it may be possible to make a link between the genetic defect     and heart or vascular disease.   "
79104|NCT02250443|"     This study is an open-label, long-term study for those patients who participated in the prior     proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM     was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to     confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing.   "
79105|NCT02250430|"     In this study, color (erythema) and pH will be measured on 3 consecutive days after     application of 2 doses of SB204 to the cheeks of healthy volunteers.   "
79106|NCT02250417|"     Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI     is the number of times per hour of sleep that the airway temporarily collapses at the level     of the tongue or soft palate. In a significant number of individuals with OSA, the severity     of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine     (back) position and lowers in the lateral (side) position. This is called positional OSA.      The primary objective of this study is to determine whether sleeping with a novel sleep     surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those     with positional OSA.   "
79107|NCT02250404|"     This pilot research trial studies molecular signatures of the return of cancer after a period     of improvement (relapse) in tissue samples from patients with small cell lung cancer who are     receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from     patients with small cell lung cancer in the laboratory may help doctors learn more about the     changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer     relapse.   "
79108|NCT02250391|"     Patients with portal vein thrombosis, who have chronic liver diseases especially liver     cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06     or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in     a randomized, double-blind, parallel-assignment design based on the proportion of patients     obtained complete recanalization or partial recanalization of portal vein thrombosis.      The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions     (ADRs) observed between administration and 21 days after administration in comparison with     the placebo group.   "
80609|NCT02231008|"     The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of     individuals with Smith-Magenis Syndrome.   "
79111|NCT02250352|"     This research trial establishes a breast tumor tissue repository from core biopsies.     Collecting breast tissue from core biopsies may allow doctors to learn more about the biology     of breast cancer and to analyze proteins, genes, and other components of tumor cells. It may     also allow doctors to conduct future studies to help understand how breast cancer grows and     how it responds to different types of therapy. This will help doctors develop better breast     cancer therapies and better tests to help make treatment decisions.   "
79112|NCT02250339|"     The purpose of this study is to examine the feasibility and the effects of family-based     interventions for children (aged 5-12) with neuropsychiatric and psychiatric disorders in     Finnish health care settings.   "
79113|NCT02250326|"     This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of     second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying     therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects     with advanced non-small cell lung cancer (NSCLC).   "
79114|NCT02250313|"     The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for     Prostate Cancer test in previously biopsied patients improves urologists' patient management     by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse     events in men being considered for a repeat procedure.   "
79115|NCT02250300|"     This is a phase I/II study of MLN9708 for the prophylaxis of chronic     graft-versus-host-disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell     transplantation (HSCT).      During the phase I portion patients undergoing both sibling and unrelated donor     transplantation were enrolled on the same arm to determine the dose-limiting toxicity (DLT)     and maximum-tolerated dose (MTD).      It was determined that the maximum tolerated dose is 4 mg. Phase I is closed.      During the phase II portion of the trial, patients will be enrolled into two separate and     independent cohorts: a) Matched sibling transplants and b) Unrelated donors transplants. Both     cohorts will be enrolled and analyzed separately.   "
79116|NCT02250287|"     The purpose of this study is to establish normal Magnetic Resonance quantitative values     (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level     Determination values for both renal cortex and medullary tissues and total renal blood flow)     for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function,     and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and     normal renal function.      Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness,     Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization     Transfer and renal blood flow) will have different values in young adult ADPKD patients as     compared to normal volunteers.   "
79117|NCT02250274|"     The purpose of this study is to assess the serologic and cell-mediated immune response to     licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in     children 5-17 years old. The effects of prior infection and or prior season vaccination will     be examined. Children will be followed during the influenza season to identify     laboratory-confirmed influenza (i.e. vaccine failure).   "
79127|NCT02250144|"     Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is     defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to     patellofemoral malalignment and soft tissue overload.      A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral     pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the     outcome of morpho-specific foot orthoses in a prospective randomized study.      The purpose of this prospective randomized study is to compare clinical outcomes in daily     living and in sports activities, between morpho-specific and placebo foot orthoses.      Morpho-specific foot orthoses are designed according to the patient's morphotype. They are     intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to     correct abnormal overload during patellofemoral tracking.   "
79206|NCT02249117|"     Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of     recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male     volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte,     coagulation, platelet and endothelial activation will be quantified; To examine the safety of     BIWH 3 in this setting   "
79118|NCT02250261|"     Walking and cycling to work is a natural way of increasing lifestyle activity in working     population. In Finland, active travel is acknowledged as one of the key components in the     most previous policy documents and initiatives related to physical activity promotion.     However, the evidence on the effectiveness and cost savings of environmental as well as     social and behavioral strategies in promoting active travel is thin both nationally and     internationally. This study focuses directly on this gap by 1) conducting a     cluster-randomized, controlled intervention where environmental change is supported with     social and behavioral strategies in a large workplace area in Tampere, Finland, 2) assessing     the cost-effectiveness and health-economic impact of the intervention and 3) examining the     environmental mediators and moderators of active commuting to work among working aged     population.      The study will be conducted in Hatanpää workplace area located just outside the city center     and including hundreds of workplaces. Workplaces with the minimum of 10 employees are     contacted for recruitment in August 2014. Baseline information is collected about the     workplaces (web-based questionnaire), employees (questionnaire, accelerometer, travel log)     and environment (traffic calculations and audit system, Geographic Information System=GIS)     first in September-October 2014 and second in March-April 2015.      In the first phase of the study a cycle superhighway across the workplace area is built by     the City of Tampere. Its' effects on walking and cycling are assessed after immediate and     mid-term (6 months) exposure with the same measures as at baseline in September-October 2015     and second in March-April 2016. In the second phase, the workplaces are randomized to     intervention and control group based on the most relevant factors related to their     comparability. Each intervention workplace nominates an internal team, which develops a     multilevel social ecological plan to promote active commuting to work. The research group     supports the teams with material, examples and three meetings. The plan is executed in May     2016 and the effects are assessed in September-October 2016 and March-April 2017. The     work-places randomized to the control group in the second phase of the study participate only     in data collection but are offered one supportive meeting for promoting active commuting to     work after the study.      Efficiency evaluation based on HEAT (Health economic Assessment Tool, www.euro.who.int/HEAT)     and costs-to-effectiveness ratios are calculated in the end of the study for the combination     of both phases as well as for the comparison of the phases. Environmental mediators and     moderators related to active commuting to work are examined objectively at all evaluation     points with GIS-analysis by connecting in-formation on physical environment to the routes,     which employees are using for commuting to work. The information on estimated routes is     obtained from the questionnaires (home and workplace addresses) and the information on actual     routes from GPS, which a subgroup of employees will provide by using free-of-charge     application (e.g. SportsTracker) in their smartphones.   "
79119|NCT02250248|"     The objective of this study is to evaluate the clinical success of AttraX Putty as a bone     graft substitute for autograft in XLIF procedures.   "
79691|NCT02242812|"     The primary objective was to show that telmisartan is not inferior to metoprolol succinate in     respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment     period. As secondary objectives, the improvement in left ventricular systolic and diastolic     function and blood pressure reduction were assessed   "
79120|NCT02250235|"     Helping patient with long-term conditions to make informed decisions about adherence to their     treatment is an important element in facilitating self-management. Estimates of non-adherence     to treatment in people living with long-term conditions are typically high, averaging at     around 50%.This not only impacts negatively on patient outcomes but also places a significant     financial burden on healthcare provision.      While clinical efforts have focused on promoting patient self-management, with some success,     work in Psychology on behaviour change has had little influence on clinical practice. In this     project, the team wish to evaluate the potential for a novel intervention from the behaviour     change literature, self-affirmation, to promote improved fluid control among non-adherent     patients. The intervention works by promoting a patient's sense-of-self (self-affirmation),     which has been shown to modify the patient's acceptance of health-risk information, their     self-efficacy, their intention to change, and subsequently their behaviour.      A randomised controlled pilot trial is proposed. The trial is designed to build upon routine     education about fluid control during dialysis visits, and will compare a group of patients     who have received an intervention to boost their sense-of-self (self-affirmation arm) to a     control group (control arm). Patients in the self-affirmation arm should have a more positive     evaluation of the health-risk information about fluid management, feel more able to, and     intend to change their fluid control behaviour, and subsequently have lower interdialytic     weight gain.   "
79121|NCT02250222|"     Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable     addition to diet and exercise to improve glycemic control in adults with type 2 diabetes     mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose     production characteristic of type 2 diabetes mellitus that is a major contributor to     hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating     doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with     type 2 diabetes mellitus.   "
79122|NCT02250209|"     The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus     XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.   "
79123|NCT02250196|"     Colonoscopy is a common screening method to detect polyps and CRC. With the early detection     of CRC through screening colonoscopy, patients could have better therapeutic effects and     outcomes. In population screening programs, an increase in completed colonoscopies is related     to a decrease in mortality from CRC. However, the miss rate for detecting colorectal     neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel     preparation results in the relatively low rate of detection of polyps and CRC, because poor     preparation interferes with successful colon mucosa examination during a colonoscopy.      Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4     liter polyethylene glycol. However, studies comparing the superiority between low-volume     bowel preparations are rare, and results are controversial. This study aimed to compare the     bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium     citrate and polyethylene glycol with ascorbic acid.   "
79124|NCT02250183|"     This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum     honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the     wound, patient satisfaction, and treatment costs in patients with partial thickness burns.     The study has four hypotheses:        1. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in          significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.        2. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield          significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria when          compared to SANTYL® sites.        3. It is hypothesized that patients will provide significantly higher patient care          satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey sites          when compared to ratings with regard to their SANTYL® sites.        4. It is hypothesized that treatment costs, across participants, will be significantly          lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.   "
79125|NCT02250170|"     This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will     characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid     tumor. Subsequently, an expansion part will further evaluate the biomarker, safety,     pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.   "
79126|NCT02250157|"     This study a nonrandomized, open-label, uncontrolled, single group assignment, safety and     activity study in subjects with histologically or cytologically confirmed solid tumor that is     metastatic or unresectable and for which standard curative or palliative measures do not     exist or are no longer effective.   "
79128|NCT02250131|"     Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide     production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in     cardiac surgery. The critical value for DO2 is around 262 - 272 mL/min/m2, and the     correspondent critical value of DO2/VCO2 ratio is around 5.0.      Patients with nadir DO2 and DO2/VCO2 ratio below these critical levels have an increased     incidence of acute kidney injury (AKI) after cardiac operations.      These observations offer an interpretation for the well-known deleterious effects of     excessive hemodilution during CPB, supported by many studies where an association between     nadir hematocrit (HCT) on CPB and bad outcomes (especially renal) was found (6-8). It is     reasonable to hypothesize that a low oxygen delivery may determine an ischemic damage to the     kidney, that due to its peculiar circulation is particularly susceptible to a decrease in the     oxygen supply.      However, there is no evidence that a strategy directed towards the specific goal of avoiding     critical values of DO2 during CPB may actually decrease the postoperative AKI rate.      The present study is designed to verify the hypothesis that a strategy based on a     goal-directed perfusion, aimed to avoid a nadir DO2 below the critical threshold, is     effective in limiting the postoperative AKI rate.   "
79134|NCT02250053|"     Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of     patients develop recurrent disease. Physical activity has emerged as a potential lifestyle     intervention to reduce cancer recurrence and improve survival among people with colon cancer     (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on     molecular and cellular pathways associated with physical activity and CC outcomes among     patients with stage II and III CC.   "
79129|NCT02250118|"     Metastatic pleural effusion is a common complication of late-stage cancer and reduces the     quality of life and survival of patients. The survival of patients with recurrent pleurisy by     uncontrolled local or systemic treatment is less than 6 months. It is important to develop     specific therapies to improve the quality of life and survival of patients with metastatic     pleurisy.      Bevacizumab is a monoclonal anti vascular endothelial growth factor (VEGF) which has proven     effective in many indications in oncology. Vascular endothelial growth factor (VEGF) is an     angiogenic factor which increases endothelial permeability. It plays a central role in many     tumors of epithelial origin. In this context, it is legitimate to ask whether an     antiangiogenic targeting VEGF may be effective in patients with metastatic pleurisy by     decreasing local blood supply and over-permeability.      No study has been interested in the intra-pleural pharmacokinetics of monoclonal antibodies     and there are no predictive or prognostic biomarkers for metastatic pleural effusions.      The investigators believe that intrapleural administration of bevacizumab will reduce the     pleural vasculature permeability. It will neutralize VEGF present in pleural fluid and reduce     the replenishment of effusion due to its prolonged half-life of 21 days.      The investigators therefore propose a phase I study to determine the maximum tolerated dose     and the recommended dose for phases II, studying the pharmacokinetics of intrapleural     bevacizumab administered by an implantable device after evacuating a symptomatic metastatic     pleurisy as part of a mammary carcinoma. The VEGF intrapleural levels and serum will be study     and the time until a new puncture. Dyspnea will be evaluated as well as its impact on quality     of life.   "
79130|NCT02250105|"     This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in     reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL)     hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week     washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins     during this period], 4 weeks for patients on statins only or not receiving any type of     lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3, at     least 7 days apart. If the baseline TG value is > 500 mg/dL and < 2,000 mg/dL, the qualified     subjects will be randomized at visit 4 and enter the double-blind, 12-week efficacy and     safety assessment phase. End-of-study lipid levels will be assessed on visits 6 and 7 (weeks     11 and 12 average). A final closeout and safety assessment visit will be done 14 weeks post     randomization   "
79131|NCT02250092|"     Hemiparetic cerebral palsy influences motor function in children during development and     throughout their lifetime. The deficits one sees are the result both of the congenitally     induced brain lesion and the subsequent plasticity that can impair function of the surviving     neurons in the damaged brain.      Many current treatments have limited influence on children's neurorecovery.     Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to     encourage use of the affected limb has shown promise, yet with new technology revealing the     potential to directly influence the brain, there is an urgent need to study the synergy of     combined techniques.      Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the     potential to act synergistically with CIMT to influence neurorecovery.      Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form     of neuromodulation, transcranial direct current stimulation (tDCS), we will investigate the     influence of this intervention on improved motor outcomes in children with cerebral palsy.     The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS     wherein those children who receive the combined intervention will reveal no major adverse     events, yet improved hand function and cortical excitability.   "
79132|NCT02250079|"     INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in     the basic technology for neonatal adaptation may not be available. Polyethylene bags may be     an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the     differences between babies undergoing body bag with polyethylene or conventional drying     during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá,     Colombia, 2013.      MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional     (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag     body and / or radiant heat lamp was removed. Environment temperature and humidity,     temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical     Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and     confidence intervals (CIs) were determined using contingency tables for risk analysis of the     outcome. The study was approved by the hospital ethics committee of victory.   "
79160|NCT02249715|"     -  To characterize physiological biomarkers of positive response to rDTMS using EEG and          functional MRI (fMRI) in patients with PD.        -  To develop a set-up and algorithm for neurophysiological monitoring for PD patients          using EEG and fMRI in patients treated by rDTMS.        -  To integrate rDTMS stimulation with monitoring techniques with the ultimate goal of          providing closed-loop feedback where monitoring informs the stimulation   "
81247|NCT02222480|"     A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the     Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in     Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension   "
79133|NCT02250066|"     investigators evaluated the efficacy of two types of diet with different macronutrients, on     prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting     glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were     randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or     control group (n=109) and followed for 2 years. For calculating daily energy requirement in     subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal     body weight with no attempt for losing body weight. Control group were encouraged to follow     the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and     saturated fat to less than 10 percent of total energy. The primary outcome variable was     incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association     criteria.   "
79135|NCT02250040|"     The purpose of this study was to identify and evaluate the effect of a new protocol of     physiotherapy to retrain walking ability after stroke in subjects older than fifty-five. This     protocol was composed of specific, clearly defined and reproducible techniques, based on     clinical and functional criteria.   "
79137|NCT02250014|"     This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in     treating patients with prostate cancer. Biological therapies, such as sargramostim, use     substances made from living organisms that may stimulate the immune system in different ways     and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells     by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate     cancer.   "
79138|NCT02250001|"     The primary objective of this study is: To evaluate the real-world safety, specifically the     incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in     Japanese patients chronically infected with HCV GT-1.   "
79139|NCT02249988|"     The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose     of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic     vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining     control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg     negative chronic Hepatitis B.   "
79140|NCT02249975|"     The purpose of this study is to assess the efficacy and performance of the C2 Focal     Cryoablation System in patients with BE.   "
79141|NCT02249962|"     To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical     outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for     Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.   "
79142|NCT02249949|"     This phase II trial studies how well efatutazone dihydrochloride works in treating patients     with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in     chemotherapy, such as efatutazone dihydrochloride, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading.   "
79143|NCT02249936|"     The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics     of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.   "
79144|NCT02249923|"     Patients are being asked to be in this research study because medical researchers hope that     by gathering information about a large number of children with pulmonary hypertension over     time, their understanding of the disease process will increase and lead to better treatment.     Investigators believe that pulmonary hypertension in children is different than pulmonary     hypertension in adults and this study will help us understand those differences.   "
79145|NCT02249910|"     This trial is conducted in Europe. The aim of this trial is to investigate the influence of     oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of     metformin and digoxin in healthy subjects.   "
79146|NCT02249897|"     There is evidence of the association between diabetic microangiopathy and elevated serum     concentrations of advanced glycation end-products (AGEs). AGEs levels are associated with     ingestion of specific foods (baked meats and milk powder); reducing their dietary intake     lowers AGEs concentrations, with beneficial metabolic effects; however threre is still no     evidence of whether this has an impact on microvascular complications of DM. We recently     applied for funding to compare in a RCT the effects of Cholestyramine versus placebo, on     visual electrophysiology. This drug is similar to Sevelamer in structure, both act as     chelators of bile salts, and reduce absorption of dietary AGE, lowering serum levels. However     it is essential to carry out preliminary tests to assess aspects that may imply adjustments     to the proposed protocol, such as: 1) tolerance to the drug 2) short term effect of the drug     versus placebo on serum levels of AGEs 3) effects of the drug versus placebo in levels of fat     soluble vitamins (D and K specifically) 4) intra and interindividual variability of     electrophysiological measurements of vision (ERGMF and optic nerve conduction velocity) 5)     drug versus placebo in electrophysiological measurements of vision (neuroconduction ERGMF and     optic nerve). Objective: The present project is planned as a pilot study, which will clarify     points 1 to 5. Methodology: patients (6 DM2, 25 -50 y) will be assessed through     anthropometry, clinical laboratory tests (creatinine, chemistry profile, lipid profile,     microalbuminuria glycosylated hemoglobin, vitamin B12, 25OH vitamin D and prothrombin),     dietary recalls specifically designed to analyze the regular consumption of AGEs, serum CML     and neuro-ophthalmological study (fundus, ERGMF and optic nerve conduction). Subsequently     each patient will be assigned to treatment with placebo for 3 months and then Cholestyramine     6 g / day for 12 weeks and at the end of each period will be reassessed using the same     methodology. If patients cannot tolerate the drug, they will be assigned to a reduced AGE     diet.      Expected results: Cholestyramine will have side effect similar to placebo (mainly digestive).     The active drug and not placebo will reduce serum levels of AGEs and electrophysiological     parameters of vision at 12 weeks. It is expected that a low AGEs diet in patients who do not     tolerate the drug will also reduce serum CML although to a lesser degree and will also induce     electrophysiologic changes.   "
79147|NCT02249884|"     Dose response curve to define the security and tolerable dose to be used for prevention and     treatment of radiodermatitis in patients with breast or head and neck cancer.   "
79148|NCT02249871|"     This trial is conducted in Europe. The aim of this trial is to investigate the influence of     omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral     semaglutide in healthy subjects.   "
79149|NCT02249858|"     Osteopathic medicine is a distinct school of medicine. Osteopathic physicians evaluate the     neuromusculoskeletal system and work to achieve normal body mechanics. They use palpation to     identify somatic dysfunctions. After performing osteopathic manipulative treatment (OMT),     such as high velocity low amplitude (HVLA), a dysfunction is reassessed by palpatory     assessment. While there are studies which show the effectiveness of OMT, a challenge remains     to objectively assess a somatic dysfunction.      The purpose of this study is to investigate the content validity of the palpatory examination     for the cervical spine using ultrasonography and the effects of a single cervical HVLA     technique. Content validity is the extent to which a measure adequately and comprehensively     measures what it claims to be measuring. The Investigators aim to objectively assess     diagnosis and treatment of the cervical spine.      HVLA technique employs a rapid, therapeutic force of brief duration that travels a short     distance within the anatomic range of motion of a joint, and that engages the restrictive     barrier in one or more planes of motion to elicit release of restriction. It is also known as     a thrust technique. The goal of the treatment is the restoration of physiological motion to     the dysfunctional joint.      Proper diagnosis of a joint dysfunction is important for spinal manipulation. Little     assessment has been made of the clinician's ability to reliably identify a joint with     biomechanical dysfunctions. Few studies attempt to address the challenge of evidence-based     clinical practice. These have found the benefit of consensus training.      In a study conducted by Shaw et al., ultrasound machine was used to assess the content     validity of palpatory examination and objectively assess the effect of HVLA in the lumbar     spine. The investigators aim to adapt the protocol for the cervical spine, but with the     addition of a control cohort. Subjects will be subjected to the cranial vault hold, which     assesses the primary respiratory mechanism in and the degree of participation of each bone in     the general motion of the cranium. In the experimental group, participants will be receiving     cervical HVLA to the key somatic dysfunction.      The Investigators hypothesize that an ultrasound is a reliable instrument to objectively     evaluate somatic dysfunction of the cervical spine. Furthermore, the investigators     hypothesize that after performing cervical HVLA, the left and right articular pillars of the     key somatic dysfunction vertebrae should be symmetrical compared to baseline.   "
79150|NCT02249845|"     The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale,     Gorelick scale) among small children.   "
79151|NCT02249832|"     The purpose of this study is to determine if intensive lower extremity robotic therapy can     improve gait speed and functional ambulation status in individuals 6 months or greater     post-stroke.   "
79153|NCT02249806|"     PH is a serious disease with a dismal prognosis and impaired quality of life when left     untreated. Reliable patient centered and prognostically relevant outcome measures are highly     warranted in the field of PH. With this prospective cohort study the investigators intend to     gain important information on the course of the disease and knowledge on the value of     different new and already established outcome parameters.   "
79154|NCT02249793|"     As citizens of the information age, humans leave digital traces of behavior in their     communication and movement patterns through our cell phone. The Global Positioning System     (GPS) technology tracks the way persons commute to school or work or when visiting family and     friends. Circadian rhythmicity describes the concept that many of the bodily functions follow     a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best     during daytime while humans rest and sleep during nighttime. The current study wishes to look     for a relationship between patterns in participants' cell phone use (Android only at this     point) and several of their bodily functions.   "
79155|NCT02249780|"     Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation     surgery. Create an objective basis for the decision whether or not to transplant the     parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and     thus abstention of systematic supplementation with calcium and vitamin D in case of good     perfusion.   "
79156|NCT02249767|"     This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male     and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild     severity) acne vulgaris were treated on the full face once daily for 84 days with the     Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by     a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at     each location.   "
79157|NCT02249754|"     Building on the success of community-based peer education and counselling in breastfeeding,     it is possible to address young child feeding and health practices in the surveyed district.     Opportunities that can optimise success and encourage behaviour change in the district     include mothers willingness to modify some feeding options; support of family members;     seasonal availability and accessibility of foods; established set-up of village peers and     existence of health centres and health staff in some villages. This study has developed a     feasible, context-specific nutrition education package for use in rural Tanzania. The package     is composed of 4 components, namely 1) education and counselling of mothers, 2) training of     community-based nutrition counsellors, 3) sensitisation meetings with health staff and family     members, and 4) supervision of community-based nutrition counsellors. The intervention will     use a parallel cluster-randomised controlled trial design where infants will be recruited     when aged 6 months and followed up for 9 months. The intervention expects to provide     information and, where appropriate, recommendations to strengthen the nutrition component in     the health education programme of the Tanzania child health services.      The study hypothesises that the nutrition education package will be more effective than the     routine health education in improving feeding practices, dietary adequacy and growth of     infants and young children. Specific objectives of the study include:        -  To evaluate the effectiveness of a nutrition education package on feeding practices and          dietary adequacy        -  To determine the effectiveness of a nutrition education package in improving growth and          health of infants and young children        -  To document the process of implementation of the nutrition education package to promote          optimal feeding and health practice   "
79158|NCT02249741|"     Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced     bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and     osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of     HOD in Indian population and its treatment outcome. The investigators aimed to determine     prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone     mineral density in patients with liver cirrhosis.      Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram     Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic     kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density     (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral     neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also     underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in     female) and parathyroid hormone (PTH) along with routine investigations. Transient     elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six     months was given in patients with osteoporosis and DEXA scan repeated.   "
79159|NCT02249728|"     The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down     and removed from the body when given as an oral capsule, a radiolabelled oral suspension and     a radiolabelled intravenous injection.   "
81248|NCT02222467|"     The primary objective of these case series is to evaluate the safety and tolerability of the     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with     venous leg ulcers.   "
79161|NCT02249702|"     The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60%     of women present with disease limited to the uterus, cure rates range from 20 to 60%.     Patients with metastatic disease at diagnosis or who recur after initial treatment have a     dismal prognosis and, except for a subset of selected patients with completely resectable     disease, the median survival is less than one year. Treatment options for     recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are     doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and     27-53%, respectively. Both these regimens have been increasingly used in the last years also     in the adjuvant setting. For relapsed patients other drugs have been tested as single agent     but negligible activity was observed.      Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated     for the treatment of patients with advanced soft tissue sarcoma, after failure of     anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS,     activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma.     Although the response rate did not exceed 10%, T was demonstrated to provide disease control,     with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20%     at 6 months. So far no phase II studies tested the activity of T in uterine leiomyosarcoma     specifically. This study is aimed at evaluating the activity of T (arm A) in advanced uterine     leiomyosarcomas, having GD (arm B) as an internal control In parallel translational studies     will be performed to identify factors predictive of the activity of T in this specific     histotype.   "
79162|NCT02249689|"     Comparison of different contact lens materials.   "
79385|NCT02246790|"     Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and     biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.      Hypothesis of the study - patients with long-standing persistent atrial fibrillation and     coronary artery disease after CABG in combination with biatrial RFA have a better outcomes     for the freedom of AF compared with patients undergoing left atrial RFA during CABG.   "
79163|NCT02249676|"     Neuromyelitis optica (NMO) is a demyelinating and degenerative disorder of the central     nervous system affecting vision and brain and spinal cord function which leads to     accumulating disability with a 5 year-mortality of approximately 30%. Survivors are typically     left with severe morbidity secondary to blindness, quadriparesis and respiratory failure. No     agent has been found to be highly effective in halting disease activity.Based on recent     outcomes of Multipotent mesenchymal stromal cells in autoimmune diseases including multiple     sclerosis, and based on the mechanisms of neuromyelitis optica, the investigators anticipate     that mesenchymal stem cells transplantation may provide lasting disease stability for     neuromyelitis optica patients.   "
79164|NCT02249663|"     To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and     Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the     relief of the signs and symptoms of Seasonal Allergic Rhinitis.   "
79165|NCT02249650|"     TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and     applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.      5441947) and Taiwan (Patent No. I432191 and I282280). The R&D laboratory in TSB is ISO/IEC     17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is     2026.The trade name of TSB-9-W1 is IDS in English, the registration number is 01472800 at     2011 by Intellectual Property Office (IPO), Taiwan.      A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the     safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal     cancer (mCRC).      there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.      This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.      Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous     3-day rest. Patient should take the study drug once daily before meal with approximately 250     ml or appropriate amount of water.   "
79166|NCT02249637|"     Given that both circumcision and orchidopexy are commonly done in a single setting, the     investigators adopted the technique of orchidopexy via circumcision incision, particularly     for palpable low inguinal cryptorchidism. In this paper, the investigators aim to present a     novel technique and discuss our preliminary outcome of such procedure compared to the     traditional inguinal-scrotal double incision technique. Specifically, the investigators aimed     to determine the differences in operative time, testicular size changes, peri-operative     complications, pain score and parent's satisfaction of both novel technique and conventional     orchidopexy.   "
79167|NCT02249624|"     Twins who share a placenta but have two separate sacs of amniotic fluid     (monochorionic-diamniotic) are at risk of developing twin-to-twin transfusion syndrome     (TTTS). TTTS results from anastomoses in the placenta that lead to unequal sharing of blood,     causing abnormal blood flow to the twins. The donor twin may have low fluid levels, poor     growth, and anemia. The recipient twin can have high fluid levels, high red blood cell     counts, heart failure, and hydrops. Having TTTS, especially if there is demise of one twin or     if disease is severe enough to warrant laser photocoagulation of the anastomotic sites, puts     the surviving fetuses at risk for brain injury due to hypoxia, ischemia, or reperfusion     injuries. Magnetic Resonance Imaging (MRI) is superior to ultrasound at detecting subtle     cerebral injuries. An MRI scoring scale has been developed for use in very low birth weight     infants that has been shown to correlate with neurodevelopmental outcomes, but it has not     been tested in this patient population.      Our center's guidelines recommend fetal MRI prior to intervention, at 32 weeks gestational     age, and on the infants at term corrected gestational age. Infants who were treated for TTTS     in utero are seen in Nursery Follow-up Clinic at 4 months of age, 8 months of age, and for     Bayley Scales evaluations at 15-18 months of age and at 2-3 years of age.      The purpose of this study is to correlate brain MRI score with neurodevelopmental outcomes in     survivors of TTTS that have either required fetal surgical intervention or had demise of     their cotwin. The investigators predict that more severe white and gray matter injury as     determined by the Woodward/Inder grading scale will be positively associated with worse     neurodevelopmental outcomes.   "
79192|NCT02249299|"     Adult patients with ADHD commonly report an improvement in behavioural symptoms when using     cannabis with some reporting a preference towards cannabis over their ADHD stimulant     medication. The EMA-C study aims to investigate the effects of a cannabis based medication,     Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.      This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will     take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance     of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before     and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in     improvements in behaviour and cognition above that of the placebo group.   "
79168|NCT02249611|"     The subjects will be recruited from July 1, 2014 until the participants enough. Interviewing     for research purpose explication and informed consent will be collected before the study is     executed. In the first 3 months, subjects of group A will use the mobile physical activity     promotion tool (MT), receive professional personal counseling, and individualized reminding     message (intervention) once a week. In the last 3 months, they will receive standard care     (control) which is in support of behavioral and educational recommendations in diet control,     increased physical activity, less smoking and drinking, deal with pressure, and regular     health examination (based on the booklet of metabolic syndrome prevention which is edited by     Health Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B     will begin with an initial 3 months control period of standard care only, and the     intervention program will be conducted for last 3 months.   "
79193|NCT02249286|"     In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than     the current nutrition and health education when investment on home-based food production is     used as a platform for nutrition education. This project is proposed to evaluate the efficacy     of a food-based package integrating child-centered nutrition counseling and home-based food     production using a between-group comparative intervention study. The intervention comprises     child-centered nutrition counseling for caretakers and support for 'developed' gardens and     improved backyard poultry production.   "
79386|NCT02246777|"     The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS™     Glaucoma Filtration Device (Ex-PRESS) in Japanese patients with normal tension glaucoma.   "
79169|NCT02249598|"     In the future it is likely that we will replace the current schedule of injected vaccines     with interventions that interrupt transmission of infections in more subtle ways. The agent     that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of     individuals. In most people, the bacterium is harmless and survives for months in the     nasopharynx, however in a minority of people the bacteria can cause invasive disease.      Simply reducing colonisation amongst target groups may protect them, and the rest of the     population as well. In a previous study we investigated cross protective antibodies, and     found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless     `cousin` of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could     lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form of     a nasal medication. The proposed study large experimental challenge study funded by     Meningitis UK that will aim to establish if N. lactamica does or does not inhibit     colonisation by N. meningitidis. We will also determine whether N. lactamica displaces     existing N. meningitidis carriage, and whether there are individuals who are innately     resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages     of 1830yrs from the two universities in Sheffield. It will involve placing droplets of     N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water like     solution into the nose of the other half of volunteers. We will carry out nose swabs at     intervals over a six month period to establish if the pattern of N.meningitidis carriage is     effected by N.lactamica colonisation. If the findings are positive we will perform future     mechanistic investigations. A62.   "
79170|NCT02249585|"     The purpose of this study is to find out the effect of low abdominal pressure vs. standard     abdominal pressure on the cardiac and respiratory function of the patients undergoing     laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the     effect of the degree of neuromuscular blockade on the surgical condition of the patients     undergoing laparoscopic colon surgery in Trendelenberg position.   "
79171|NCT02249572|"     The purpose of this study is to compare the outcome of patients with vestibular schwannomas     in two groups of randomised to either radiosurgery or expectation.      The optimal treatment for a small vestibular schwannoma is a matter of controversy and there     are no class 1 studies investigating this. Even the natural tumor growth rate remains     controversial and is reported to be from near 100% of cases showing growth to 40-60% in     various reports. The clinical results of various treatment strategies are documented, but     comparative studies are very few. Immediate radiosurgery or wait-and scan with subsequent     treatment upon growth are two strategies that have both been used in many different centers.     There are only two studies comparing these treatment modalities .These studies indicate     significant effect of GKRS in reducing tumor growth, with less differences in hearing and     complaint outcomes. None of the studies are blinded or randomised, allowing for bias.      The present study aims at comparing the two modalities above. To achieve this, we intend to     randomise patients with newly diagnosed VS to either of Wait-and Scan or immediate     radiosurgery.      The primary study endpoint is the relative tumor size measured as the ratio between tumor     volume at four years compared with volume at inclusion. Secondary endpoints include symptom     and sign development measured by clinical examination and by patient's responses to     standardised validated questionnaires. In addition, the health economics involved with both     strategies will be evaluated and compared, as well as the patient's working status.      Patients will be asked to participate if their VS is diagnosed within the last six months,     their age is between 18 and 70, and pending there are no exclusion criteria (see below). A     power analysis indicates that about 50 patients per group is sufficient.      In case of failure to recruit patients, we will change the design to a study based on     patient's own choice of treatment.      The study will be announced according to international guidelines. A steering committee will     monitor the study and an intermediate analysis will be performed when the study group has     been followed for two years. If the effect aim is already observed, the study should     nonetheless continue, as it is too early to evaluate the results after such a short time     course.      It will also be discussed to do a follow-up of all patients ten years after inclusion.   "
79172|NCT02249559|"     This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife     subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain     stimulation.   "
79173|NCT02249546|"     Helicobacter pylori infection has been shown to be associated with the development of gastric     cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the     occurence or recurrence of these diseases. The triple treatment including a proton pump     inhibitor, clarithromycin, and amoxicillin or metronidazole to treat H pylori infection,     proposed at the first Maastricht conference has become universal since all the consensus     conferences and guidelines around the world recommended it. However, the eradication rate of     clarithromycin-based triple therapy has been declining in recent years, probably related to     the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients     would fail from first line standard eradication therapy and need second line rescue therapy.      The H. pylori persistence in human infections and its resistance to the drugs commonly used     in antimicrobial therapy have been attributed not only to genetic variability, but also to     ability of H. pylori to form biofilm as a strategy to overcome environmental stress and to     protect itself. Several recent reports indicate that H. pylori forms biofilm either in vitro     or in vivo, N-acetylcysteine (NAC) were thought to reduce and prevent biofilm formation. Two     small-scale clinical trials showed NAC offers additive effect on eradication effects of H.     pylori therapy. A recent trial showed N-acetylcysteine pre-treatment before a culture-guided     antibiotic regimen is effective in treating refractory H. pylori infection.      Aims: Therefore, we aim to assess        1. Whether triple therapy containing N-acetyl cysteine is more effective than standard          triple therapy        2. the impact of antibiotic resistance and cytochrome P450 C19(CYP2C19) polymorphism on the          eradication rate of triple therapy containing N-acetyl cysteine.   "
79205|NCT02249130|"     To investigate the safety of a standard triple therapy regimen of delavirdine (DLV),     zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with     regimens of tipranavir (TPV) with and without ritonavir (RTV)   "
79210|NCT02249065|"     This study is designed to:        1. assess the signs and symptoms of rosacea, including erythema, without treatment and          during treatment with Mirvaso® gel        2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment        3. gain a better understanding of the real-world use ofMirvaso® on the pattern and          management of facial erythema of rosacea.   "
79211|NCT02249052|"     The purpose of this study is to determine whether collagenase is effective in reducing the     surface area of a subcutaneous benign lipoma.   "
79212|NCT02249039|"     Critically ill infants and children who are mechanically ventilated are often given large     doses of opiates and benzodiazepines to provide analgesia-sedation. These drugs significantly     cause tolerance and dependence, depresses the drive to breathe, and thus prolongs the need     for mechanical ventilation and the associated complications. We propose IV CLON could be used     as effectively as DEX.   "
79174|NCT02249533|"     Sports-related traumatic brain injuries (TBIs), including mTBIs—commonly referred to as     concussions—are a serious public health concern. Diagnostic criteria and consensus return to     play (RTP) guidelines exist, but clinicians have varying approaches to the diagnosis and     management of sports-related concussion as these guidelines are almost completely unsupported     by an evidence base. It is well known that by increasing awareness of concussion signs and     symptoms as well as the importance of addressing this injury, improving coaching on proper     sports activity techniques and good sportsmanship, providing appropriate protective     equipment, and quickly responding to injuries, the incidence, severity, and long-term     negative health effects of sports-related concussion among children and adolescents can be     reduced. The overall objective of this application, which is the first step toward attainment     of our long-term goal, is to evaluate the effectiveness of Spot Light (a concussion injury     management application [app] that coordinates diagnosis, management, and RTP procedures from     injury to safe return to sport) when utilized by youth football teams. Our central hypothesis     is that youth football teams randomized to receive SpotLight will report increased rates of     concussion, increased referrals to physicians for care, and increased athlete compliance with     RTP guidelines. The rationale that underlies the proposed research is that providing an easy     to-use app has a high probability of effectively helping people involved with youth sports     better recognize, respond to, and ensure athletes are fully recovered from sports-related     concussion. We will test our hypothesis by pursuing the following aims: 1: Evaluate whether     Spot Light will increase reported rates of sports-related concussion; Aim 2: Evaluate whether     Spot Light increases referrals to physicians following concussion; Aim 3: Evaluate whether     Spot Light improves the management of sports-related concussion. We expect to determine     whether there is increased reporting, referrals to physicians, and athlete compliance with     RTP guidelines. This contribution will be significant because it will allow physicians,     athletic trainers (ATs), coaches, and parents to collaboratively track concussions from     injury through safe RTP thereby lessening the chances of long-term negative outcomes as well     as acute catastrophic outcomes.   "
79175|NCT02249520|"     This is an extended pilot protocol to facilitate on-site calibration of the technical aspects     of the new Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic     Resonance (PET-MR) scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging     Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a     FDA-approved standard clinical device (non-experimental) and will be used in accordance with     clearance and approval from the FDA.   "
79176|NCT02249507|"     Aerobic exercise has the potential to diminish blood pressure values. The aim of this study     is to determine whether this potential is also applicable for those with resistant     hypertension and whether exercise intensity plays a role in this context. We hypothesize that     performing an aerobic exercise session reduces blood pressure values in resistant     hypertensive patients in a dose-response relation with exercise intensity.   "
79177|NCT02249494|"     The purpose of this study is to investigate whether the use of a mobile app could improve     knowledge and practice in nutrition counseling performed by primary care physicians in     Brazil.   "
79178|NCT02249481|"     Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24     and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score     which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic     team).      Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior     patient mobilisation within the first 48 hours following total knee replacement compared to     femoral nerve catheter infusions.      Secondary Objective: To identify whether adductor canal nerve infusions result in superior     analgesia within the first 48 hours following total knee replacement compared to femoral     nerve catheter infusions.   "
79179|NCT02249468|"     Difference in nutritional status between patients with mild and moderate Alzheimer's Disease     (AD) and cognitively intact healthy people in an Asian population   "
79180|NCT02249455|"     To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in     promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients   "
79181|NCT02249442|"     To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir     (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency   "
79182|NCT02249429|"     The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the     Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of PQR309     administered orally, as once daily capsules continuously and now on intermittent schedule in     patients with relapsed or refractory lymphomas.   "
79183|NCT02249416|"     The objective of this study was to characterize the effect of two dose combinations of     tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered twice     daily on the pharmacokinetics (PK) of zidovudine (ZDV) and zidovudine-glucuronide (GZDV) as     well as the effects of zidovudine on the pharmacokinetics of TPV/RTV   "
79184|NCT02249403|"     The objective of this trial was to assess the dose-response relationship of symptomatic     efficacy of talsaclidine base on ADAScog and to assess safety and tolerability   "
79185|NCT02249390|"     The purpose of the study is to collate local information to better understand the     motivations, accessibility and frequency of assisted reproductive technology (ART) use in the     community.   "
79186|NCT02249377|"     This is a Prospective study with Randomized patients into either Ultrasound-guided     Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3 months     and 6 months follow ups after aspiration at our institution. There will be 25 patients in     each group, including any patient with symptomatic baker's cyst.   "
79187|NCT02249364|"     Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what     extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.      Two particular aspects of this study are        -  the inclusion of women undergoing one day gynecological surgical procedures        -  the use of a closed-loop system which delivers propofol according to bispectral index to          provide induction of anesthesia.   "
79188|NCT02249351|"     Study to assess symptomatic efficacy, safety and tolerability of talsaclidine in patients     with mild to moderate dementia of Alzheimer type   "
79189|NCT02249338|"     Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils     and specific inflammatory markers in patients with clinically well-defined moderate chronic     obstructive pulmonary disease (COPD)   "
79190|NCT02249325|"     This pilot quasi experiment was designed to determine the feasibility of a randomized     controlled trial of the oral probiotic combination of Florajen3 (>7.5 x109 L. acidophilus,     >6.0 x109. B. lactis, and >1.5 x109 B. longum) taken orally once daily beginning at 28 weeks     gestation, against placebo, to reduce the colonization of group B Streptococcus at 36 weeks.   "
79191|NCT02249312|"     Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in     patients with asthma   "
81249|NCT02222454|"     The primary objective of these case series is to evaluate the safety and tolerability of the     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with     stage II or III pressure ulcers.   "
79194|NCT02249273|"     Background: Inappropriate use of antibiotics is one of the main causes for the increase of     antibiotic resistance strains. In Denmark general practice accounts for 90% of all prescribed     antibiotics and one of the most common reasons for prescribing antibiotics is the suspicion     of a urinary tract infection (UTI). The use of point-of-care test is meant to decrease the     uncertainty about the bacterial origin of the symptoms; however, there is a paucity of     knowledge about the validity of the different diagnostic approaches, thus impacting on the     proper use of antibiotics.      Objective: To assess the diagnostic validity of different diagnostic approaches in patients     with a suspected urinary tract infection and assess the impact on appropriate use of     antibiotics.      Methods: 70 practices at the capital region will consecutively include 15-20 patients. The     inclusion criteria of the patients comprise: a) Suspected Urinary tract infection, b) > 18     years of age, c) patient consulting during office hours. Data at patient and GP level will be     gathered.      16 diagnostic approaches will be compared and proper use of antibiotics will be assessed as a     two-step process. The first step is the decision made during the consultation and the second     step is the decision made after the consultation. Sensitivity, specificity and predictive     values will be measure for each diagnostic approach using urine culture as a gold standard.     The impact on proper use of antibiotics will be assessed in a hierarchical multivariable     logistic model.   "
79195|NCT02249260|"     Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of     this study is to examine factors who predict long-term effects of improved peak oxygen uptake     one year after participating in cardiac rehabilitation.      Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac     rehabilitation program.   "
79196|NCT02249247|"     Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL     284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety     in patients with chronic obstructive pulmonary disease (COPD)   "
79197|NCT02249234|"     There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with     scrotal pain that we found published.      We proposed a pilot study using Botox to block the nerves on a small group of men with     chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have     had temporary relief from a testicular cord block using local anaesthetic drug.      The encourage results of the pilot study has given us the background information to proceed     with a formal randomised control trial of Botox vs placebo.      We hypothesized that Botox injections to block the testicular nerve will be effective in     providing long term pain relief for men with scrotal pain.   "
79198|NCT02249221|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of     GC3106 after single intramuscular administration in Korean healthy adults.   "
79199|NCT02249208|"     The purpose of this study is to determine the detection rate and the false negative rate of     sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to     radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant     chemotherapy in patients with node-positive breast cancer converted to node negative after     treatment by ultrasound. A randomized controlled trial.   "
79200|NCT02249195|"     Study will recruit pregnant or postpartum women presenting to Groote Schuur Hospital with     cardiovascular disease in 20 consecutive patients and will insert an implantable ECG     monitoring device. The patient will then be followed up over a duration of two year and will     be monitored for arrhythmia and mortality.   "
79202|NCT02249169|"     This longitudinal study is being done to understand mechanisms underlying development of     irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms.     This information will be used to determine whether temporal changes in gut microbial taxonomy     and metabolism are associated with changes in symptom severity in IBS, and if targeted     dietary interventions, including prebiotics, can reverse or moderate these changes.   "
79203|NCT02249156|"     Several employers in the US have introduced a program where their employees receive a     financial incentive to receive lower cost care. Under this Rewards program, patients are     free to choose providers but if they visit a pre-determined low-cost laboratory or radiology     facility (called a rewards provider), they receive a financial incentive. The financial     incentive is typically in the form of a Health Savings Account (HSA) contribution. The dollar     amount varies by employer. This study will use medical claims data to examine if this program     leads to an increase in the volume of services performed by low-cost providers and decreased     health care spending.   "
79204|NCT02249143|"     The primary aim of this study is to quantify and compare changes in lung volumes (as measured     by functional residual capacity) in premature infants stable on continuous positive airway     pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room     air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an     increased functional residual capacity (at the end of the two week study period and prior to     discharge) compared to those randomized to room air.   "
79207|NCT02249104|"     The goal of this study is to evaluate a complete topical acne regimen consisting of a     prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil®     DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer     SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.   "
79208|NCT02249091|"     Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several     drugs with different ways of inhibiting the cell growth. In this trial, standard     chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will     be combined with a new drug called Selinexor.      Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus     which control the cell growth.   "
79209|NCT02249078|"     This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled,     sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability,     pharmacokinetics (PK), and pharmacodynamics (PD) of 3 subcutaneous and 1 intravenous dose of     E6011 in subjects with active Crohn's disease (CD). Thirty-two subjects will be randomized to     one of 4 dose cohorts (8 per cohort) and will receive E6011 or placebo for 10 weeks. The     first 3 cohorts will receive E6011 or placebo via subcutaneous injection and the last cohort     will receive E6011 or placebo by intravenous injection. The ratio of E6011 to placebo within     each cohort will be 3:1. The study has 2 phases: Prerandomization and Randomization.   "
79213|NCT02249026|"     Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for     NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic     treatment; those infants born to mothers with co-dependence on an opiate and a     benzodiazepine. Although there are concerns, we anticipate that buprenorphine will be safe in     this population. If it is safe, we can include these infants in the large double blind,     double-dummy buprenorphine and clonidine vs. morphine and clonidine trial. If on the other     hand, these infants have respiratory depression or other adverse events when buprenorphine is     given, it will be important to report this study and caution the use of buprenorphine in     these infants   "
79214|NCT02249013|"     This is a phase II open label, single arm clinical trial on safety and efficacy exploring an     short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) as     upfront therapy for patients with advanced Epithelial Ovarian Cancer (EOC) undergoing     Cytoreductive Surgery (CRS).   "
79215|NCT02249000|"     First-in-Human clinical investigation to evaluate the safety and clinical performance of the     BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis,     which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve     implantation   "
79216|NCT02248987|"     The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity     according to the antipsychotic treatment response in schizophrenia.   "
79217|NCT02248974|"     The goal of this project is to develop a patient-centered decision aid for decision-making     about end-stage heart failure treatment. This study seeks to create a decision aid that     presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular     Assist Device (LVAD) placement to help patients make values-based decisions about placement.     The investigators propose a mixed methods design involving a literature search of clinical     evidence, semi-structured patient interviews, and quantitative data from a multi-site trial     of patients receiving the decision aid compared to patients not receiving the aid.   "
79218|NCT02248961|"     Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung     Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),     manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablet 50/100 mg in adult patients     with Grade I-II arterial hypertension in 12 weeks of therapy   "
79219|NCT02248948|"     This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the     Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.   "
79220|NCT02248935|"     The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse     from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y     smartmesh lightweight mesh.   "
79221|NCT02248922|"     The purpose of the study is to evaluate lung clearance index (LCI) by a standardized     procedure in a well characterized study setting and to assess feasibility of LCI as a more     sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of     antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung     disease.   "
79222|NCT02248909|"     This study is an observational multicenter descriptive study. The study will be conducted in     primary outpatient medical institutions in different cities of the RF. Primary care doctors     who are primary contact for greater part of the population in RF including COPD patients will     be invited as investigators. This observational descriptive study will be conducted within     the routine practice of outpatient institutions. Since spirometry is not an integral part of     the current all-round clinical practice, only those sites where spirometry test is routinely     used in examination of patients with COPD risk factors and when monitoring condition of COPD     patients will take part in the study. Thus the decision about spirometry in every study     subject will be determined only by the existing treatment approaches.   "
80170|NCT02236533|"     The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of     a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus     coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized     controlled trial.   "
79223|NCT02248896|"     The primary objective of this study was to assess whether there is an increased risk of     sepsis with the use of telmisartan compared with other ARBs and with the other major     antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A     secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other     three major antihypertensive classes and with untreated hypertension, is associated with an     increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan     compared with other ARBs, ACEIs and other major antihypertensive classes is associated with     an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and     death   "
79224|NCT02248883|"     To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the     QT interval more than placebo co-administered with ritonavir   "
79225|NCT02248870|"     Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24     hours in patients with hip fracture would have a major impact in order to provide better     preoperative analgesia for this group.      In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone     to the local anesthetics doubled the analgesic duration. No studies has investigated the     effect of the addition of Dexamethasone to the femoral nerve block in patients with hip     fracture.      The aim of our study is to investigate if more patients with hip fracture experience lasting     preoperative analgesia until the time of operation or 20 hours after a femoral nerve block     with the addition of Dexamethasone compared to the same nerve block done without     Dexamethasone.   "
79226|NCT02248857|"     The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS),     which was designed as a strategy to standardize and simplify medication instructions to     support safe and effective prescription drug use among diabetic.   "
79227|NCT02248844|"     This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness     of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous     glabellar lines.   "
79387|NCT02246764|"     The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil     (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active     comparator Timolol Maleate Ophthalmic Solution, 0.5%.   "
79228|NCT02248831|"     Historically, ultrasound imaging of the lung parenchyma has been challenging because of the     high total ultrasound energy attenuation and scattering by the air in the lungs. However,     recent technological advancements have allowed for rapid assessment of various pulmonary     diseases via the use of lung ultrasound. Furthermore, it has been shown that clear     reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed     Doppler ultrasound system incorporating a special signal-processing package.      The LDS may contain information of significant diagnostic and physiological value regarding     the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general.     In a pilot clinical validation study of patients with acute decompensated heart failure     (ADHF) patients, LDS signals unique to ADHF patients were identified, that superpose on the     normal Lung Doppler Signals (unpublished data). These are high velocity disorganized     variable signals that are not synchronous with the cardiac cycle but rather sometimes with     respiration.   "
79229|NCT02248818|"     This is a randomized, double-blind, placebo-controlled study of single and multiple ascending     dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening     period, an in-house period during which AZD8108 or placebo will be administered orally as a     solution, and a 4- to 10-day follow-up period after discharge.   "
79230|NCT02248805|"     The primary goal of this Phase 1 study is to characterize the safety and tolerability of     MGD007 and establish the maximum tolerated dose (MTD) of MGD007 administered on either weekly     or every three week schedules of administration among patients with metastatic colorectal     carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 will     also be assessed.   "
79231|NCT02248792|"     Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe     psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis,     more so if disease is severe.   "
79232|NCT02248779|"     The purpose of this study is to better understand the risk factors and causes of diabetes in     people who received radiation to the abdomen as children. The investigators hope this     information will allow them to improve how they screen people at risk for diabetes and how     they treat patients in the future.   "
79233|NCT02248766|"     The aim of this dispensing study is to evaluate the clinical performance of existing wearers     of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.   "
79234|NCT02248753|"     A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent     reason for visits to the emergency department. Currently, in the majority of cases, immediate     (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates     spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control     medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be     effective, safe and more cost-effective than current standard of care and could lead to a     higher quality of life.   "
79235|NCT02248740|"     The aim of this study is to perform a randomized, prospective trial comparing the two current     methods of treatment for chronic venous insufficiency related to the Small Saphenous Vein     (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one     is superior to the other.   "
79236|NCT02248727|"     The aim of this dispensing study is to evaluate the clinical performance of existing wearers     of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily     wear.   "
79237|NCT02248714|"     The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed     type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS     (continuous glucose monitoring system) and to further realize the safety and effect of     Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.   "
79238|NCT02248701|"     The purpose of this study is to determine whether testosterone plus finasteride treatment     will improve musculoskeletal health, neuromuscular function, body composition, and metabolic     health in hypogonadal men who have experienced ambulatory dysfunction subsequent to     incomplete spinal cord injury. The investigators hypothesize that this treatment will improve     bone mineral density, enhance muscle size and muscle function, and improve body composition,     without causing prostate enlargement.   "
81250|NCT02222441|"     This study is designed to evaluate the potential effect of the moderate CYP3A inducer     modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.   "
79239|NCT02248688|"     The purpose of this pilot study is to achieve the collection of safety and efficacy data in     patients undergoing left gastric artery embolization for morbid obesity in the United States.     As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is     not designed to achieve new indications for this device.   "
79240|NCT02248675|"     There is a strong association between sleep disturbance and suicidal thoughts and behaviors.     Sleep disturbance is also highly comorbid with other common conditions associated with     suicide such as depression and posttraumatic stress disorder. Accordingly, this application     focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a     broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral     Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in     Veterans who also suffer from additional conditions. The proposal further suggests that     adding this sleep intervention to usual care may further enhance overall care by increasing     the utilization of recommended treatments for depression and posttraumatic stress disorder.   "
79249|NCT02248558|"     Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote     HIV testing among key populations such as men who have sex with men (MSM) and transgender     (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of     a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in     China. The crowdsourced video was developed using an open contest, formal transparent     judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video     will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported     first-time HIV testing within 3-4 weeks of watching the video.   "
79417|NCT02246374|"     This is primarily a safety protocol to evaluate the safety of unilateral subthalamotomy using     Transcranial ExAblate in a staged, escalating dose titration manner; Stage I is     subtherapeutic; Stage II is full, therapeutic unilateral lesioning.   "
79241|NCT02248662|"     Despite the large number of women affected, the optimal treatment strategy for DCIS is not     known. To enable informed decision-making by DCIS patients, we seek to provide individualized     data about outcomes following breast conserving-surgery with and without radiation therapy -     in terms of recurrence, disease-free and overall survival, and likelihood of long-term breast     conservation. To do this, we will study patient-specific risk factors for having a new breast     cancer after DCIS and the likelihood of breast-conserving surgery versus mastectomy if a     woman has a 2nd cancer diagnosis after DCIS and has not received radiation upfront, using 4     large datasets. The results of these analyses will then be combined into a model which will     generate individually tailored predictions of the long-term likelihood of breast conservation     with and without radiation therapy for DCIS. We will then design a web-based decision aid to     present the tradeoffs and compare expected treatment outcomes with and without radiation     therapy. This decision aid will enable patients and their physicians to choose the treatment     most consonant with patient preferences, and will improve both the quality of decision-making     and quality of life for patients diagnosed with DCIS.   "
79242|NCT02248649|"     This project is investigating whether a home-based exercise program will reduce cognitive     decline in patients with Parkinson's disease.   "
79243|NCT02248636|"     This study tries to determine if stopping certain medications that are used to treat dementia     will cause worsening from the patient and family perspective.      All of the participants will take pills that look identical, and that may contain active drug     or an inactive pill (a placebo). Half of the group will receive the same treatment they were     taking before the study -- this is called the sham discontinuation arm. The other half will     receive a reduced dose of their medication, and then an inactive pill (placebo) -- this is     called the real discontinuation arm.      Participants will be able to return to their previous dose of medication at any time during     the study. The percentage of people who return will be measured and compared. Other medical     events and factors such as behaviors, thinking, and caregiver distress, will be measured and     compared between the groups.   "
79244|NCT02248623|"     A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience     of surgery is the most secure way to prevent awareness with recall. Fortunately the incidence     of awareness with recall (the patient can spontaneously remember the intraoperative event) is     very rare (0.1-0.2%). However the investigators systematic review suggests that consciousness     of intraoperative events may occur in approximately 37% of patients in experimental studies     (as identified by the validated clinical procedure the isolated forearm test that does not     require postoperative recall of the event). In this international cohort study, recruiting a     minimum sample of 200 patients, the investigators will investigate the incidence of     anaesthesia awareness (as identified by the isolated forearm test) following the induction of     anaesthesia and before surgery.   "
79245|NCT02248610|"     In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators     will collect real world data on their short and long term outcomes. The investigators     hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will     be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2.     there will be less bleeding than when patients are on conventional anticoagulants; 3. there     will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary     hypertension and post-thrombotic limb syndrome.   "
79246|NCT02248597|"     This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in     treating patients with hematological diseases. Giving chemotherapy before a donor stem cell     transplant helps stop the growth of cells in the bone marrow, including normal blood-forming     cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused     into the patient they may help the patient's bone marrow make stem cells, red blood cells,     white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an     immune response against the body's normal cells (called graft-versus-host disease). Giving     cyclophosphamide after the transplant may stop this from happening.   "
79247|NCT02248584|"     The objective of this study was to evaluate the effects of supplementary antioxidant therapy     on the levels of biomarkers and inflamatory citocines in patients with a previous history of     non-melanoma skin cancer treated with surgery. This was a double-blind, randomized,     placebo-controlled trial. Patients were randomized into two groups, one receiving placebo     (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50     mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from     patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite,     thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as     well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two     different times: (1) one day before the start of supplementation or placebo administration     and (2) at 60 days after intervention. Statistical analyses were performed with the SAS     System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.   "
79279|NCT02248168|"     The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as     shown below through the Post Marketing Surveillance (PMS) study upon approval.        -  Unexpected adverse events (especially, serious adverse events (SAEs))        -  To find out the status of incidence of adverse events under actual practice        -  Factors on the safety profile        -  Factors on the efficacy profile   "
79248|NCT02248571|"     This is a clinical trial with a crossover design to determine patients' preference for     capecitabine in combination with bevacizumab or everolimus in combination with exemestane for     advanced breast cancer patients and to evaluate, if any combination is associated with a     better quality of life.      To identify patients' preference for either therapy in this trial, patients without disease     progression or other reasons for early discontinuation will be asked for their treatment     preference and their treatment satisfaction. To correlate patients' preference with other     patient reported outcomes (PROs), quality of life (QoL) will be assessed at baseline and     throughout the study, using dedicated questionnaires.      With similarly active treatment options, it is of utmost importance to identify the treatment     that has the least negative impact on the patients' quality of life.   "
79418|NCT02246361|"     The purpose of this before-after prospective multicenter study is to assess the impact of     six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and     adherence scale for common acute illnesses in emergency ward.   "
79250|NCT02248545|"     Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat,     barley, and rye) that primarily affects the small intestine in genetically predisposed     patients and resolves with exclusion of gluten from the diet. Patients with CD show     circulating autoantibodies (anti-transglutaminase, anti-tTG) and suffer from the destruction     of a specific tissue cell type (the enterocytes) by CD8+ T cells. Furthermore, other     autoimmune diseases have been reported in association to CD in 20-30% of the cases. In the     last few year, a new clinical entity emerged, which seems include patients who consider     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac     Gluten Sensitivity (6), but, in a recent paper, the investigators suggested the term     Non-Celiac Wheat Sensitivity (NCWS), since, to date, it is not known what component of     wheat really causes the symptoms. The doubt areas about the NCWS regard also its pathogenesis     as, despite some papers evidenced an intestinal immunologic activation, others excluded it.     To explore the presence of autoimmunity in NCWS, the investigators evaluated: a) the     frequency of autoimmune diseases and b) the frequency of serum anti-nuclear antibodies (ANA)     positivity in newly diagnosed NCWS, compared to CD patients.   "
79251|NCT02248532|"     The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with     chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is     (1) on repetitive administration of cell therapy that would allow for long-lasting     improvements in heart function and outcome in this patient population. In parallel, the     investigators aim to (2) develop a standardized patient-specific stem cell product that could     be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for     therapeutic application when clinically indicated. By using a unique multimodality imaging     platform, the goal of this project is also to (3) define standardized clinical criteria that     would serve as a guideline for evaluation of the effects of stem cell therapy in future     clinical trials and everyday clinical settings. Finally, to improve the clinical     implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery     technique that could be used to treat both left and right and ventricular failure and could     be implemented in a standardized fashion designed for a widespread clinical use.   "
79252|NCT02248519|"     This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for     resectable gastric cancer in a Western population. The hypothesis is that laparoscopic     gastrectomy will result in a lower post-operative burden by means of shorter post-operative     hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated     with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better     post-operative quality of life, with similar mortality and oncologic outcomes, compared to     open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take     three and five years respectively. Short-term results will be analyzed and published after     discharge of the last randomized patient.   "
79253|NCT02248506|"     To determine proportion of women achieving clinical and mycological cure or have recurrences     / reinfection after being treated for an acute episode of vulvovaginal candidiasis.   "
79254|NCT02248493|"     The purpose of this study is to define if intravenous paracetamol may improve analgesia and     outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs     (NSAIDs) postoperatively.      Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV     ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and     adolescents following surgery.   "
79255|NCT02248480|"     The main purpose of this study is to evaluate the efficacy of the study drug known as     duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.   "
79256|NCT02248467|"     The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible     for bariatric surgery, the effect of testosterone replacement therapy in improving lower     urinary tract symptoms (LUTS) assessed using the IPSS (International Prostate Symptom Score)     questionnaire, compared to hypogonadal untreated subjects and eugonadal subjects.   "
79257|NCT02248454|"     The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.      Subjects will have several admissions during which the investigators will apply an iterative     dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin     ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The     investigators hypothesize that the incremental insulin dose required to cover dietary fat in     patients with type 1 diabetes will be related to total daily insulin dose (U/kg).   "
79258|NCT02248441|"     The present study will evaluate whether treatment with daily remote ischemic conditioning for     a 28±4-day period induces beneficial effects in subjects with and without chronic ischemic     heart failure in terms of improved left ventricular contractile function and exercise     capacity.   "
79259|NCT02248428|"     Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple     Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic     regimens with new drugs. Clarithromycin may have partly efficacy in association with steroids     and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase 3 clinical     trial is proposed to explore whether clarithromycin could potentiate responsiveness of CTd     (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly Diagnosed Multiple Myeloma     patients. The trial will also evaluate the side effects caused by the combination of these     drugs.   "
79260|NCT02248415|"     The aim of this study is to compare the effect of warm blood cardioplegia administration with     and without roller pump on perioperative myocardial injury, reflected by postoperative     biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a     minimal extracorporeal circuit (MECC).   "
79261|NCT02248402|"     Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using     dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma.     Vax-DC/MM is an potent immunotherapeutic agent generated by dendritic cells loaded with the     ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this study is to     examine the safety and efficacy of Vax-DC/MM in patients with relapsed or refractory multiple     myeloma.   "
79472|NCT02245659|"     Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in     pregnant patients with sleep-disordered breathing and gestational diabetes   "
79262|NCT02248389|"     The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity     focused ultrasound to target and ablate tumors. It also does not require piercing the tumor     with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also     have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus,     there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback     could replace RF and Cryo for the treatment of small renal masses where the invasiveness of     full resection partial nephrectomy is contraindicated due to patient comorbidities.   "
79263|NCT02248376|"     The primary purpose of the study is to compare efficiency of a non-stick gel application     after scraping surgery for natural miscarriage with no non-stick gel application after     scraping surgery.      Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8     weeks after surgery.   "
79264|NCT02248363|"     Chronic pain is a common health problem that causes enormous social costs. A common method     for treating patients with chronic pain problems are multimodal rehabilitation (MMR), which     consists of a combination of physical exercise, cognitive behavioural therapy and work     training coordinated in an interdisciplinary team. Our research aims to evaluate the     effectiveness of MMR on health, quality of life, physical activity, return to work and health     economics, with the long-term goal of developing MMR. We aim also to evaluate predictive     factors for good and bad treatment outcomes in order to better adapt the MMR to the patient.     The project is based on patient-reported data from the Swedish Quality Registry for Pain     Rehabilitation, which routinely collects data from 40 (2017) Swedish specialist MMR clinics     from all parts of the country. We expect increased knowledge of treatment effects and how MMR     can be effectively adapted according to the patient's limitations and resources. Our project     group is interdisciplinary and is active in nationwide research networks that focus on     chronic pain and rehabilitation.   "
79265|NCT02248350|"     This main purpose of this study is to examine the effects of an exercise intervention to     counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate     cancer patients. Specifically, a supervised and home-based exercise program will be used to     assess its impact on clinical and behavioral variables related to ADT in prostate cancer     patients.   "
79266|NCT02248337|"     Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel     disease.   "
79267|NCT02248324|"     The purpose of this study is to determine whether common genetic polymorphisms that have been     verified to be related to age-related macular degeneration (AMD) in some populations are also     associated with AMD in Turkish population   "
79268|NCT02248311|"     Current methods based on traditional Cardiovascular risk factors are not clinically useful     for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic     events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in     Type 2 Diabetes population have worse prognosis than in general population. In fact, there is     sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects     of ischemic events and worsens their outcome.      A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes     patients. Therefore, new strategies aimed at identifying those patients with this subclinical     Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a     challenge to be met.   "
79269|NCT02248298|"     Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line     treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative     fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment     of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is     limited   "
79280|NCT02248155|"     The objectives of this Post Marketing Surveillance (PMS) are:        -  Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS)          severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical          Global Impression Improvement scale (CGI- I)        -  Evaluation of the time to reaching maintenance dose of pramipexole        -  Evaluation of work productivity impairment associated with RLS based on the Work          Productivity and Activity Impairment Questionnaire (WPAI) questionnaire   "
79281|NCT02248142|"     Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I     and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)   "
79282|NCT02248129|"     Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics     and hypertensive with renal insufficiency (observed data) in the study population, with the     objectives of the High Authority for Health recommendations (benchmark)   "
79283|NCT02248116|"     Safety and tolerability. Quality of life (EQ-5D, ACQLI) and health economic impact (health     resource utilisation, living and employment status) assessments, will not be performed at the     centers in the united kingdom (UK)   "
79284|NCT02248103|"     A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison     with collagen membrane for management of periodontal intrabony defects.   "
79285|NCT02248090|"     This is a phase 1 open label multicentre study of AZD9496 administered orally in patients     with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose     with intensive safety monitoring to ensure the safety of patients. The study will determine     the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic dose(s)     in patients with or without ESR1 mutations will be enrolled to further determine the safety,     tolerability, pharmacokinetics and biological activity of AZD9496   "
79286|NCT02248077|"     This study is designed to demonstrate the outcome of complete ulcer closure of patients with     Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary     Care (UCC).   "
79384|NCT02246803|"     The aim of this study is a comparative evaluation of progression of paroxysmal atrial     fibrillation in patients with coronary artery disease after isolated CABG and CABG combined     with pulmonary vein isolation.      Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery     disease after CABG in combination with isolation of the pulmonary veins have a better     outcomes for the progression of AF compared with patients undergoing isolated CABG.   "
79270|NCT02248285|"     BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a     rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common     microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/)     from a stool specimen collected in Cary Blair enteric transport media. The test was made     available for sale in the US and EU following FDA clearance and CE marking in May, 2014.      The FilmArray GI Panel offers improvements over conventional laboratory testing which     include: reduced turnaround time from specimen to result, reduced laboratory labor costs,     increased sensitivity and specificity relative to current clinical reference methods, and     larger breadth of organism identification than is available using standard methods. Because     of these attributes, the results from this test have the potential to enable clinicians to     more accurately diagnose and treat GI illness in a reduced time frame.      Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics     have designed a study to evaluate health outcomes of pediatric subjects presenting to     emergency departments with GI illness before and after establishing the FilmArray GI Panel as     the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (~     1 hour turnaround time), sensitive, specific, and comprehensive results provided by the     FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate     appropriate therapy and provide guidance when compared to the pre-implementation period.   "
79271|NCT02248272|"     This study investigated any potential associations between two isocaloric diets with     different meal frequency (3 meals versus 6 meals) and glycemic control in people at high     diabetes risk (lean and overweight/obese women with PCOS and individuals with     hyperinsulinemia) and diagnosed with diabetes.   "
79272|NCT02248259|"     The objective of the current study is to evaluate the effect of once daily itraconazole on     the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.   "
79273|NCT02248246|"     This is a prospective, non-randomized, single arm, multicenter, observational study to assess     the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing     during laparoscopic colectomy. The study will not modify or influence current surgeon     technique. Investigators will perform each procedure using the device in compliance with     their standard surgical approach and product labeling.      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in     accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,     calibrated, and/or used in accordance with manufacturer design specifications, product     instructions and guidelines.   "
79274|NCT02248233|"     Massive cerebral infarction is an ischemic stroke caused by complete blockage of the internal     carotid artery, middle cerebral artery, or their cortical branches. The widespread     infarction, pathological severity and high fatality rate associated with massive cerebral     infarction pose a major threat to affected patients. However, there is a lack of unified     diagnostic criteria. Many researchers use Adams' classification, in which massive cerebral     infarction is diagnosed when the following criteria are met: infarct size > 13 cm2; a major     brain-feeding artery is involved; the focal site affects more than two cerebral lobes;     infarct diameter line ≥ 3 cm in internal capsule of striatum.      Prolonged cerebral ischemia/reperfusion can induce complex secondary changes in brain tissue,     so the use of neuroprotective agents is very important. Remarkable progress has been made     over the last decade in understanding the protective effect of calcium antagonists against     cerebral ischemia. In particular, the liposoluble dihydropyridine Ca2+ antagonist nimodipine     selectively acts on cerebral vessels and neurons and can protect ischemic brain tissue,     providing a new way of treating ischemic cerebrovascular disease.      Preclinical and clinical tests have shown that nimodipine has a protective effect on ischemic     brain tissue, and indicate that patients should take the drug as soon as possible. However,     there are no reports of double-blind, randomized, controlled clinical trials addressing the     administration of nimodipine via intravenous drip within the time window for successful     treatment of acute massive cerebral infarction.   "
79275|NCT02248220|"     Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor,     depression, anhedonia and tolerability   "
79276|NCT02248207|"     Study to obtain information about the co-operation of the different physician-colleagues in     the treatment of patients with Parkinson's disease, both in private practices and clinics and     about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to     collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's     disease under routing conditions   "
79277|NCT02248194|"     Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood     ﬂow and heavy menstrual bleeding affects up to 30% of women at some time during their     reproductive years. Abnormal menstruation can be due to conditions such as pregnancy     complication uterine fibroids and adenomyosis, but in a large proportion of cases, the     etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding     (DUB). Treatment options for DUB include symptomatic medical treatment or surgery,     traditionally hysterectomy.      Hysteroscopically guided endometrial ablation methods have been shown to be effective and     safe alternatives to hysterectomy for management of DUB. These methods require particular     skills and experience and a long learning curve to be performed effectively and safely.      Through the past three decades DUB patients in Assiut university hospital were treated with     either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges     during transcervical resection of the endometrium or rollerball coagulation, we used to shift     to thermal balloon as backup method . However, expensive uterine balloon could not     infrequently be afforded because of financial constrains and limited health resources .     Therefore, another method was used as backup for hysteroscopic failures. It was first tried     via insulating the conventional double-ended uterine curette then through a specially     designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely similar     to the dilatation and curettage procedure both principally and practically. Hence, the basic     requirements for its performance are the general awareness with electrosurgical principles     and adequate experience in performing dilatation and curettage. TEA is done by specially     designed tactile diathermy probe that carried the job of electrosurgical ablation without     hysteroscopy or distension media first in an experimental session that clearly clarified the     reproducibility of the depth of thermal damage and safety of the tactile electrosurgical     ablator . Thereafter, TEA was successfully performed with satisfactory short and medium term     outcomes for ten cases with DUB during an active, relentless bleeding attack. TEA is done     under laparoscopic monitoring.      The aim of the present work is to present TEA as a simple, inexpensive, novel backup approach     for treatment of DUB.   "
79278|NCT02248181|"     Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and     dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms,     assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and     L-Dopa when given concomitantly.   "
84225|NCT02183831|"     This study was set up to identify clinical outcomes including a refractive shift or change in     IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes     without zonular instability.   "
79287|NCT02248064|"     Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive     pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home,     from time to time patients still have low oxygen levels especially when walking which can be     harmful.      The investigators have designed a new system of delivering oxygen to overcome the above     problem. The system measures the oxygen saturations of a patient and subsequently adjust the     flow of oxygen to meet a pre-set oxygen saturation target.      Hypothesis: the investigators intelligent oxygen therapy system is better at reducing low     levels of oxygen during a 6 minute walk than usual ambulatory oxygen for patients with     chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.   "
79288|NCT02248051|"     The main purpose of this trial is to demonstrate the safety, tolerability and     pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient     population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition,     associated pharmacodynamic (PD) effects of CXA-10 will be investigated.   "
79289|NCT02248038|"     The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable     colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was     not inferior to open surgery.   "
79290|NCT02248025|"     Fluid responsiveness in a context of circulatory failure can be assessed by different way.     Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the     available device are expensive and the analysis are delayed. Capillary refill time (CRT) is     hampered by its variability. The investigators have developed a method to standardize the     pressure, the length of compression and a computerized analysis to calculate the capillary     refill time. This method enables accurate measure of CRT.      The investigators will study if CRT variation induced by a passive leg raising (PLR) can     predict CRT after a 500 ml Fluid Load.      About thirty patients in circulatory failure with a continuous cardiac output monitoring for     whom, the attending physician has decided a fluid load, will be included. hemodynamic     parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters     (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by     sublingual video-microscopy) and capillary refill time measured on the thorax and on the     gingival area will be recorded. Data collection will be made before and after a passive leg     raising and after a 500 ml fluid load of crystalloids.      Patients will be aposteriori sorted in two groups: responders and non responders, defined by     the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after     PLR to predict in which group each patient is classified will be investigate and receiver     operative characteristic curve will be built. These results will be compared to the metabolic     response, the macrocirculatory response, and the microcirculatory response.   "
79291|NCT02248012|"     To study the efficacy of everolimus combined with temozolomide as first-line treatment in     advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as     disease control rate (non-progressive disease) at 6 months.   "
79292|NCT02247999|"     Background:        -  Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical          cancer are caused by the human papillomavirus (HPV). HPV is more common in women who          have the human immunodeficiency virus (HIV). India has one of the highest rates of women          who have both cervical cancer and HIV infection.        -  Cervical cancer can be discovered in early stages by screening for HPV infection.          Researchers want to compare new cervical cancer screening tests for HIV-infected women.          They also want to know more about how HPV can lead to cervical cancer in HIV-infected          women. To do so, they will hold a study to screen HIV-infected women in India.      Objectives:      - To improve cervical cancer screening methods in HIV-infected women in India.      Eligibility:        -  Women at least 18 years of age who have HIV infection.        -  Participants will be recruited from HIV-focused health care clinics in Pune and Chennai,          India.      Design:        -  Participants will have a physical exam and medical history. They will provide a urine          sample and proof of HIV infection.        -  Participants will have a gynecological exam. This will involve a pelvic exam and Pap          smear to collect cells for study. It will also involve a cervical exam to look for          precancerous cells. Cervical tissue may be collected.        -  Participants will also provide a blood sample for testing.        -  Participants will return in 2 weeks for the test results. If there are signs of          precancerous or cancer cells, participants will be referred to a doctor for treatment.   "
79303|NCT02247856|"     Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are     well-established, but couple to nebulization is still challenging. Aim: To compare     radioaerosol pulmonary deposition and radioaerosol mass balance in the different compartments     (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet nebulizer (JN)     coupled to NIV.Methods: It was a crossover study involving 9 stable moderate to severe COPD     randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and phase 2(NIV+JN,n=9).     Bronchodilators were delivered during NIV using a facemask (pressures of 12 cmH2O and 5 cmH2O     - inspiratory and expiratory, respectively). Radioactivity counts were performed using a     gamma camera and regions of interest(ROIs) were delimited. We determine aerosol mass balance     from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory     filters, and mask as a percentage.   "
79304|NCT02247843|"     This Phase I clinical trial will assess the safety and initial evidence for efficacy of an     autologous transplant of lentiviral vector modified bone marrow for adults with severe sickle     cell disease.   "
80194|NCT02236221|"     The purpose of this study is to observe the effect of lack or excess of Vitamin D in the     first, second and third trimester on child birth weight, fat content and the secretion of     metabolism related hormone, and clinical follow-up their offspring obesity.   "
79318|NCT02247661|"     A prospective cohort study to compare the direct lateral and poster-lateral approach     concerning abductor function. Patients admitted with a femoral neck fracture operated with a     hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for     inclusion. Patients with altered mental status SPMSQ >7, pathological fractures, non-walkers     were excluded.      Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1     year postoperatively by clinical examination. Sample size were estimated to 30 patient in     each group. Primary outcome variables were trendelenburg test, abductor strength measured     with dynamometry, trochanteric tenderness measured with algometry and palptation.   "
79293|NCT02247986|"     Background:      - Disruptive behavior is a common problem for children and adolescents. It can be treated     with some success with stimulant medicine. Researchers want to learn more about how this     works.      Objective:      - To learn how the brain changes when taking the medicine methylphenidate for behavior     problems.      Eligibility:        -  Children ages 10 17 with conduct disorder and/or attention deficit disorder.        -  Healthy volunteers the same age.      Design:        -  Participants will be screened under a separate protocol.        -  Participants will have two 3-hour sessions at the clinic. Girls who are menstruating          will have a pregnancy test before their scans.        -  Visit 1: All participants will:        -  Perform simple tests on a computer.        -  Fill out a questionnaire along with their parent or guardian.        -  Have an MRI scan. A magnetic field and radio waves take pictures of the brain.          Participants will lie on a table that slides into a metal cylinder. A coil will be          placed over their head. They will be in the scanner for 60 minutes, lying still or          performing a simple task. They will practice the task before the scan. A computer screen          will show them task information during the scan. The scanner makes loud knocking sounds.          Participants will get earplugs. Their parent or guardian can stay with them during the          scan.        -  Only participants with behavior disorders will:        -  Take a pill of the study medicine or placebo.        -  Be monitored for any side effects.        -  Visit 2 is a repeat of Visit 1, except participants who got a pill in Visit 1 will get          the other pill in Visit 2. For healthy volunteers, the 2 visits are exactly the same.   "
79294|NCT02247973|"     The study is a phase II trial designed to evaluate the efficacy and safety of     co-transplantation with bone marrow derived mesenchymal stem cells from related donors in     alternative donor transplantation of severe aplastic anemia.   "
79295|NCT02247960|"     The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary     catheter removal decreases the number of symptomatic urinary tract infections in patients     after radical prostatectomy. In addition, the investigators aim to determine whether     antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from     antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The     investigators also aim to identify specific populations that may be at higher risk of     developing urinary tract infections with urinary catheter use after radical prostatectomy.   "
79296|NCT02247947|"     Proteomics is used to identify prognostic markers after CPR. Additionally neurological     outcome should be estimated by specific protein alterations and affections of pathways.   "
79297|NCT02247934|"     The objectives of this qualitative study are to elicit concepts about symptoms that are     important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts     of symptoms on patients' day-to-day functioning.   "
79298|NCT02247921|"     Stroke is the second leading cause of mortality and disability among adults worldwide.     Rehabilitation is an effective treatment for stroke; however rehabilitation services are far     from adequate in China, especially in rural areas where the health and economic burden of     disability from stroke is very high.      The investigators propose to develop, implement, and evaluate an evidence-based     caregiver-delivered stroke rehabilitation program designed to improve the physical     functioning of disabled stroke patients in rural China.   "
79299|NCT02247908|"     The purpose of this randomized controlled trial is to determine whether graphic health     warnings on cigarette packs are more effective than the existing Surgeon General's warning on     cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate     graphic warnings have been informative, they have used psychological outcomes, such as     attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts).     Furthermore, they typically expose participants to warnings in controlled but artificial     experimental settings for a short period of time, using much lower frequency and shorter     duration of warning exposure than found in the real world. This study addresses these issues     by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have     their cigarette packs labeled with either a graphic warning or a Surgeon General's warning     for four weeks.      Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will     be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized     to receive a Surgeon General's label on their cigarette packs.      Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs     will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon     General's label on their cigarette packs, controlling for baseline quit intentions.   "
79300|NCT02247895|"     Patients who are admitted to the intensive care unit and require mechanical ventilation     frequently develop profound respiratory and limb muscle weakness. Studies show that the     development of weakness during the ICU stay results in poor outcomes. Currently there are no     treatments for this muscle weakness, but it has been suggested that this weakness might     improve with physical therapy. Electrical stimulation is a method to provide direct     stimulation to the muscles potentially enhancing function and improving strength. The purpose     of this study is to test the hypothesis that neuromuscular electrical stimulation of the     quadriceps muscle will improve muscle strength in patients who are critically ill on     mechanical ventilation.   "
79301|NCT02247882|"     The purpose of this study is to determine whether education or aquatic physical therapy are     effective in the treatment of osteoarthritis in Knee due to intensity of pain, function     capacity, quality of life and kinetic.   "
79302|NCT02247869|"     Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD     (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin     Lymphoma.   "
79317|NCT02247674|"     The investigators hypothesized that bilateral handgrip force training would result in     significant improvements in paretic hand, arm movements and daily functional performances. In     order to investigate whether the improvement of paretic hand could facilitate the motor     recovery of paretic arm and functional performances, the investigators also hypothesized that     motor recovery and functional performances improvements of paretic arm and hand have strongly     correlation.   "
79347|NCT02247284|"     The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™     OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new     software (glaucoma premium module) with the well established peripapillary RNFL thickness     measurements in patients with primary open angle glaucoma.   "
79305|NCT02247830|"     It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the     prevention of radiodermatitis in patients with breast cancer or head and neck cancer     undergoing radiotherapy.      Prophylactic Trial will consist of a control group and two experimental groups, namely     control group (usual care), Experimental Group 01 (usual care + topical application of the     gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based     cream).      The doses used in the different compounds are being in test since february 2014 by a     dose-response curve study, using 6 groups with three doses of urea cream and three doses of     C. recutita gel.      The study will be conducted at the Center for High Complexity Oncology at University Hospital     of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according     to established criteria to classify the effects of radiotherapy, which identifies grades 0,     1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To     evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse     Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).   "
79306|NCT02247817|"     Cardiac resynchronization therapy has become one of the cornerstones of the treatment of     heart failure. However, a large proportion of patients still fails to this type of therapy.     This may be due to a suboptimal position of the left ventricular pacing lead, which may be     caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video     assisted thoracic surgery is more flexible and evades the venous system altogether, resulting     in a much more favorable position of the pacing lead, with better treatment results as e     consequence.   "
79307|NCT02247804|"     This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in     patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month     treatment period with an 8-month extended follow-up.   "
79308|NCT02247791|"     The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as     an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a     displaced femoral neck fracture.   "
79309|NCT02247778|"     Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7     to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of     this incision secondary problems like prolonged fracture healing, paresthesia of     supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a     mini-incision technique using an average incision length of 4cm.      The aim of this study is to analyzed whether secondary problems following plate     osteosynthesis of the clavicle correlate mit the length of the surgical access.   "
79310|NCT02247765|"     To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject     population during motion over a specified saturation range.   "
79311|NCT02247752|"     The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We     spoke first from HBsAg healthy carrier , then from  asymptomatic carrier , last from     HBsAg inactive carrier . This definition continue to be not totally consensual. A very low     viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases     and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status     on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of     alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40     UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a     year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some     patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently     normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in     order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver     cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis     criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg     quantification for the prognosis of such events or, in contrary HBs seroconversion; will     evaluate the influence of B genotype on HBsAg level; will evaluate the influence of     comorbidities on unexpected arrival of such events.   "
79312|NCT02247739|"     Primary Objective:      To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of     angioedema attacks in patients with HAE      Secondary Objective:      To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the     prophylaxis of angioedema attacks in patients with HAE   "
79313|NCT02247726|"     The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein     nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess     the impact of maternal immunization on infant safety through one year of life.   "
79314|NCT02247713|"     A part retrospective, part prospective cohort study to assess the difference in 2-year     overall survival in patients with stage III NSCLC receiving chemoradiotherapy with curative     intent in low and middle income countries before and after a training intervention on the use     of PET/CT for radiotherapy treatment planning.   "
79315|NCT02247700|"     Respiratory disorders are the leading cause of respiratory failure in children. Thousands of     children are admitted to a pediatric intensive care unit each year and placed on mechanical     ventilators. Despite over 40 years since the first pediatric-specific ventilator was     designed, there has been no specific cardiopulmonary directed therapy that has proven     superior. While mechanical ventilation is generally lifesaving, it can be associated with     adverse events. There is evidence building to suggest that adopting a lung protective     ventilation strategy by the avoidance of lung over-distension and collapse reduces death.     Therefore, timely discovery of these two lung conditions is extremely important in order to     mitigate the effects associated with positive pressure mechanical ventilation. The     investigators research team has extensive research experience with a non-invasive and     radiation free medical device called electrical impendence tomography (EIT). EIT is intended     to generate regional information of changes in ventilation. Meaning it can detect this     collapse and overdistension. This additional source of information could help fine tune the     mechanical ventilator. A baseline of understanding of how often this occurs in the patients     the investigators serve is required. Therefore the investigators propose an EIT observation     study in their pediatric ICU patient population.   "
79316|NCT02247687|"     Management of participants with low-level persistent viremia   "
79320|NCT02247635|"     The metabolic syndrome is a group of cardiometabolic risk factors that reflect a sedentary     lifestyle and the excessive intake of food among the risk factors that comprise it are     located the obesity, hyperglycemia, dyslipidemia and hypertension.      It has been observed that the interventions of lifestyle changes that promote weight loss     through the practice of physical activity and intake of a hypocaloric diet, reduce the     prevalence of chronic diseases such as Metabolic syndrome.      Adherence is defined as the extent to which a person's behaviour - taking medication,     following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations     from a health care provider. The World Health Organization has estimated that in developing     countries, as in Mexico, less than 27% of people with chronic diseases will continue     treatment as directed.      Adherence to treatment of chronic disease is a multifactorial problem that includes not only     patient-related barriers, but also providers of health services and social security systems     themselves. Furthermore, as WHO has pointed out, as increasing prevalence of chronic     non-adherence to treatment will become a global problem even more serious.      The purpose of this study is develop and implement a methodology to overcome barriers     affecting adherence to treatment of women over 20 years with non-communicable diseases such     as metabolic syndrome (diabetes , hypertension and dyslipidemia) evaluating its impact     through various quantitative indicators such as weight loss or metabolic syndrome prevalence.      This study will include two phases:        1. Phase 1. Design. Qualitative methodology was used primarily to identify the barriers          faced by individuals to adhere to treatment. From this methodology, we developed a tool          to assess adherence to treatment of subjects with these conditions and then an          intervention to improve it.        2. Phase 2. Implementation of intervention (24 weeks). To recruite a group of 180          overweight and two of the following comorbidities: diabetes mellitus, dyslipidemia or          hypertension. All study subjects will be randomized to a control group and intervention.          The control group will receive a medical traditional clinical care. The intervention          group will receive a lifestyle treatment with behavioral intervention to improve          adherence for improve eating behaviors, physical activity and metabolic control.   "
79321|NCT02247622|"     PSC is a chronic cholestatic disorder. The investigators intend to study some telomere     parameters and telomere length in order to predict a premalignant state.   "
79322|NCT02247609|"     Currently, a majority of B cell lymphomas cannot be cured by standard chemo-radiotherapy.     Most B cell lymphomas express cluster of differentiation antigen 19 (CD19), which represents     a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This     study will evaluate a novel 4th generation CD19 CAR engineered with a self-withdrawal     mechanism (19273-4SCAR) for both efficacy and safety in lymphoma patients.   "
79323|NCT02247596|"     The primary aim of our study was to examine the effects of two weeks of oral resveratrol on     resting energy expenditure and insulin sensitivity in non-diabetic obese male subjects.     Secondary variables included plasma lipid subfraction, blood pressure and glycated hemoglobin     (HbA1c).   "
79324|NCT02247583|"     Prospective non-interventional non-controlled multicenter observational study to evaluate     aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an     oral anti-cancer drug.      The main objective of this study is to evaluate the patient perspective in the treatment of     advanced renal cell carcinoma with an oral anti-cancer drug.      The following aspects will be investigated:        -  Intrinsic desire for information about treatment.        -  Patient satisfaction with treatment information.        -  Patient satisfaction with treatment.        -  Medication adherence.        -  Health-related quality of life.        -  The role of different health care professionals in the treatment of RCC with oral drugs      This study should reveal information necessary for the development of pharmacotherapeutic     care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug     over a long period.   "
79325|NCT02247570|"     The specific aim of this proposed study is to compare the effectiveness of Vestibular     Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain     injuries in a randomized controlled trial in terms of PTSD symptom reduction.   "
79326|NCT02247557|"     To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the     treatment of IC/BPS   "
79327|NCT02247544|"     This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison     end point. This study aims at confirming the activity of the drug trabectedin as     second/further line treatment in retroperitoneal leiomyosarcoma and well     differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth.      Another objective is to investigate this peculiar benefit of trabectedin in typical     retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making     in the management of retroperitoneal sarcomas   "
79328|NCT02247531|"     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled     study evaluating the efficacy and safety of lampalizumab administered by intravitreal     injections in participants with geographic atrophy (GA) secondary to age-related macular     degeneration (AMD).   "
79329|NCT02247518|"     The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic     properties of tadalafil   "
79330|NCT02247505|"     The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic     properies of tamsulosin   "
79345|NCT02247310|"     Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as     well as the challenge to achieve high adherence to treatment, evaluating the benefits of any     new measure to improve adherence is important. The data storage capabilities of the     BETACONNECT device, including the automated recording of injections, will facilitate the     collection of reliable data on patient's injection behavior and adherence, which should be     unaffected by recall bias or reporting bias.      To better understand the utilities of the new BETACONNECT device and characterize its     contribution to adherence, we plan to prospectively follow-up MS patients using this device     for 24 weeks. The study will take place in a real-life setting in Neurology centers across     Europe.   "
79346|NCT02247297|"     This prospective, single centred cohort study evaluates the physiological course of the     potentially novel biomarker PSP in pregnant women as well as its predictive role in the     development of inflammatory complications during pregnancy.   "
79359|NCT02247128|"     At present, a variety of antithrombotic regimens are prescribed in the early postprocedure     period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT)     using aspirin and a thienopyridine in the initial period after TAVI is the recommended     strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior.     In patients with atrial fibrillation (AF) or another indication for oral anticoagulation     (OAC), no recommendations on best treatment regimen currently exist although triple therapy     (OAC + DAPT) is best avoided due to increased bleeding risk.      We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and     not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).   "
82059|NCT02211872|"     The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI     2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of     safety, efficacy, and pharmacokinetics of BI 2536 BS   "
79331|NCT02247492|"     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to     long-term complications range from rather immediate elastic coil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),     designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis     rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS     substantially reduced the incidence of abrupt artery closure, but restenosis still occurred     in about 20 to 40% of cases, necessitating repeat procedures.      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by     adding an antiproliferative drug (directly immobilized on the stent surface or released from     a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS     with systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease.      Therefore this observational registry has been designed for the clinical evaluation of the     ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and     collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting     Stent System in an all-comers patient population in daily clinical practice.      Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the     patient's body inflammation status correlates with the clinical outcome.   "
79332|NCT02247479|"     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled     study evaluating the efficacy and safety of lampalizumab administered by intravitreal     injections in participants with geographic atrophy (GA) secondary to age-related macular     degeneration (AMD).   "
79333|NCT02247466|"     The purpose of this study is to investigate surgical work space and surgical conditions in     patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The     patients will act as their own control with evaluation of surgical work space and surgical     conditions during both deep NMB and no NMB.   "
79334|NCT02247453|"     In the present project we propose a large prospective study in heavy smokers volunteers based     on plasma miRNA profiling to assess its efficacy as a first line screening test for lung     cancer detection.      The study will be articulated in different phases: i) analysis of 1000 plasma samples of     disease-free smokers already collected in our biological repository in the last two years ii)     de-novo enrollment of 4000 smoking volunteers, collection of their blood samples and     inclusion in a program of active surveillance on the basis of their miRNA risk profile iii)     assessment of miRNA expression profile using a custom made microfluidic card containing the     24 miRNA previously identified in the diagnostic signatures iii) bioinformatic analyses of     miRNA ratios in the cohort in order to determine which individuals are in presence or will     develop lung cancer and in particular the aggressive form of the disease iv) assessment of     the best diagnostic and treatment algorithm for subjects with suspicious miRNA profiles v)     functional validation of miRNAs as novel therapeutic targets using novel cellular genetically     engineered models of transformation and patients' tumorgrafts models.   "
79335|NCT02247440|"     This is a study of HCV treatment using the standard regimen of pegylated-interferon plus     ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment     will be implemented in conjunction with gastro-enterologists/hepatologists by internists     responsible for the participant's HIV treatment.      Chronic hepatitis C virus (HCV) infection is responsible for several severe and life     threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected     patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV     replication is suppressed on antiretroviral treatment.      The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows     fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured     are no longer contagious to other individuals, therefore widespread access to HCV treatment     may contribute to the control of the HCV epidemic.      A combination of injectable pegylated-interferon with oral ribavirin is currently the     recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They     are administered for 24 weeks in HCV mono-infected patients but need to be administered for     one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV     protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in     patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter     treatment.      PRIMARY OBJECTIVE      1. To determine the percentage of patients according to genotypes with sustained virological     response 6 months after treatment discontinuation (SVR).      HCV TREATMENT        -  Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)        -  Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of          anemia.      A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a     first part (starting in August 2014) and 45 patients in a second part, depending on funding.   "
79336|NCT02247427|"     The purpose of this study is to determine clinical outcomes related to deactivation of     Cardiac Resynchronization Therapy device in subjects with super response.   "
79337|NCT02247414|"     The purpose of this study is to determine whether Warfarin Anticoagulation are effective and     safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic     Splenectomy and Azygoportal Disconnection for Portal Hypertension   "
79338|NCT02247401|"     This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive     and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.   "
79339|NCT02247388|"     To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in     the Emergency Department.   "
79340|NCT02247375|"     Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.   "
79341|NCT02247362|"     One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q     (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for     safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled     study.   "
79342|NCT02247349|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics,     immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in     combination with nivolumab in patients with relapsed/refractory SCLC.   "
79343|NCT02247336|"     Family health history can help identify patients at higher than average risk for disease.     There is no standardized system for collecting and updating family health history, using this     information to determine a patient's disease risk level, and providing screening     recommendations to patients and providers. Patients will enter their family health history     into MeTree, a family history software program. The program will produce screening     recommendations tailored to the patient's family health history. The investigators will     examine whether this process increases physician referrals for, and patient uptake of,     guideline-recommended screening for colorectal cancer.   "
79344|NCT02247323|"     The investigators are assessing the incidence of ovarian cancer in premenopausal women who     were at moderate risk of malignancy with low CA125.   "
79348|NCT02247271|"     This project is a partnership between the University of Victoria and the eleven Diabetes     Health Centres in the Fraser Health Region of BC. The primary goal of this project is to     evaluate the feasibility, viability, and effectiveness of using peer health coaches to assist     persons with type 2 diabetes who are experiencing challenges in managing their diabetes. The     University of Victoria will recruit and train sixty coaches with various cultural and     socioeconomic backgrounds representing a community of practice. Coaches will also have type 2     diabetes and will have led or taken the Diabetes Self-Management Program in English, Punjabi     or in Aboriginal communities. Training will also include navigating the health care system,     accessing mandated health and employment- related services, importance of medication     adherence and ability to understand health care instructions. Three hundred subjects with     type 2 diabetes will be recruited by Diabetes Health Educators. Eligibility criteria for     subjects include: adults with type 2 diabetes attending a Diabetes Health Centre, A1C over 8%     within the past 6 months, and ability to speak English or Punjabi. A randomized controlled     trial design will be used. After completing baseline measures subjects will be randomly     allocated to a group which will get the coaches or to a control group. Measurements will     again take place at six and twelve months. The Diabetes Coaches will provide assistance to     subjects and their families for up to 6 months. A project community advisory committee     comprised of the researchers, Diabetes Centre administrative staff, clinicians, coaches,     subjects, key community leaders and representatives from the diabetes industry will meet     every three months to guide implementation and sustainability. Qualitative research methods     (i.e., focus groups and interviews) will be used to gather feedback, perspectives, and     opinions of all the stakeholders.   "
79349|NCT02247258|"     The objective of this study is to evaluate if in the prevention of postoperative recurrence     of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to     delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by     endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and     surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment.   "
79350|NCT02247245|"     To examine the effects of heart rate reduction on exercise capacity in control subjects and     patients with chronic heart failure.   "
79351|NCT02247232|"     This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group     comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical     cancer on radiotherapy. The study will use a central randomization with a dynamic allocation     using biased coin minimization.   "
79352|NCT02247219|"     The study aims at:      Using Intervention mapping as a planning approach for behavior change intervention programs,     based on an ecological approach to health and local community and user participation.        -  Explore the behavioral change processes utilizing qualitative methods.        -  Develop theory-based behavior change programs across different domain at healthy living          centres.        -  Evaluate the effect of behavior change intervention programs across different domains.        -  Increase health providers` competence in effective behavioral change intervention          techniques by networks and education seminars between municipalities and research          groups.        -  The programs will specifically target the underlying causes of chronic disease. The          investigators will map the distribution of lifestyle habits among individuals and          families. The investigators will also explore how lifestyle habits relate to known          determinants of social health inequality, such as adverse previous experiences,          participation in working life and low income.        -  The investigators also intend to study if socioeconomic differences are of importance          for entering or dropping out of HLC interventions, and the ability to sustain lifestyle          changes. The investigators will do so by stratified analyses, or by using socioeconomic          variables as determinants in effect analyses.   "
79353|NCT02247206|"     The purpose of this research is to examine the preliminary efficacy, feasibility, and     acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette     Syndrome through in a randomized waitlist-controlled trial.   "
79354|NCT02247193|"     Objectives: To determine if the use of botulinum toxin during primary cleft lip repair     improves the cosmetic appearance of the scar      Study Design: Double blinded randomized controlled trial      Methods: Study to be completed at an academic tertiary hospital. Patients must be 6 months of     age or younger with a unrepaired complete unilateral cleft lip and palate requiring a primary     cheiloplasty. Botulinum toxin will be injected intraoperatively at 4 standardized sites in     the cleft lip during surgical repair. Control subjects will receive a placebo injection in     place of the toxin. Surgeons will be blinded to patients that receive the experimental     injection. Outcomes will be determined using 3D-videography preoperatively and post     operatively at scheduled visits with a total of one year follow up. A scar assessment     questionnaire will be completed by parents at select post operative visits. Videography     images will also be assessed by a blinded expert panel at the completion of the study.   "
79355|NCT02247180|"     This study aims to proof the efficacy of a cognitive rehabilitation program for patients with     mild dementia in Alzheimers Disease with respect to activities of daily living.   "
79356|NCT02247167|"     Sleep disordered breathing (SDB) is a common disease in both adults and children and is     caused by the obstruction of the upper airway during sleep. Unlike adults, most cases of     paediatric SDB are due to the presence of enlarged tonsils and adenoids, thus the main     treatment option is adenotonsillectomy (AT). It is well known that obstructive sleep apnoea     (OSA) in adults increases the risk for hypertension, coronary artery disease and stroke, and     there is now mounting evidence that SDB also has a significant impact on the cardiovascular     system in children with reports of elevated blood pressure, endothelial dysfunction and     altered autonomic cardiovascular control.      Oxidative stress seems to play a pivotal role in impairing flow-mediated dilation (FMD) and     consequently enhancing cardiovascular risk in SDB patients but the underlying mechanism is     still undefined.      Previously, we demonstrated that endothelial dysfunction is directly related to NADPH oxidase     activation. Furthermore, recently we assessed the association between OSA, endothelial     dysfunction and oxidative stress in adults showing that increased NADPH oxidase-generated     oxidative stress and arterial dysfunction are partially reversed by nasal continuous positive     airway pressure treatment.      There is evidence in literature that cardiovascular morbidities associated with SDB are     potentially reversible in children; AT may have a significant role in reversing the     cardiovascular sequelae of SDB (e.g. children with OSA).      Nowadays, there aren't studies that analyzed the role of NADPH oxidase-generated oxidative     stress in SDB children.      The purpose of the current research project is to examine the role of NADPH oxidase activity,     oxidative stress, inflammation and endothelial function in SDB children, understanding the     mechanisms involved in this disease.      Furthermore we will analyse the effect of a AT on inflammation, oxidative stress, NADPH     oxidase activity and endothelial function in SDB children.   "
79357|NCT02247154|"     To determine:        1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency          (PAD or SAD).        2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.        3. The half-life of Vigam® Liquid after 4 months of treatment.        4. The subclass and total gammaglobulin concentrations after each infusion of Vigam®          Liquid.   "
79358|NCT02247141|"     The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®)     given subcutaneously by weekly infusion to patients with primary antibody deficiency.      The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly     infusion to patients with primary antibody deficiency.   "
79360|NCT02247115|"     The establishment of a number of training programs in therapeutic endoscopy, standardization     of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde     cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The     length of training and minimum number of procedures, requisite theoretical learning and     methodology to define competence in EUS and ERCP are not well defined. The investigators     research has demonstrated that individuals in training acquire skills at different rates and     the number of procedures completed alone is a suboptimal marker for competency in a given     procedure. Hence, emphasis needs to be shifted away from the number of procedures performed     to performance metrics with well-defined and validated thresholds of performance. Multicenter     prospective data are needed to help guide development of competency based medical education     that define learning curves in EUS and ERCP and set evidence-based benchmarks required to     achieve competence using a validated competency assessment tool.      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment     tool will allow for reliable and generalizable standardized learning curves, competency     benchmarks and creation of a centralized national database that compares a trainee's     performance amongst peers.   "
79361|NCT02247102|"     The study shall investigate whether isomaltulose        -  is digested and absorbed to a comparable degree like other carbohydrates (CHO) used as          ingredients for this age group (e.g. sucrose), by measuring the H2 exhalation in the          postprandial period        -  does not mediate abdominal discomfort or diarrhoea and is therefore as well tolerated as          other CHO (e.g. sucrose), by/in healthy infants aged 6 to 12 months.      It is hypothesized that isomaltulose, provided with a standard follow-on formula,        1. will not significantly increase the mean basal breath H2-excretion rate (determined as          the incremental area under the curve (iAUC) of H2-exhalation) over a 3 h postprandial          period compared to a sucrose containing standard follow-on formula.        2. will not lead to a significantly different gastrointestinal tolerance in the conse-quent          24 h after formula consumption compared to a sucrose containing standard follow-on          formula in infants aged 6 to 12 months.   "
79362|NCT02247089|"     Background:      The sympathetic and parasympathetic branches (SNS and PNS) of the autonomic nervous system     (ANS), keep our body in a state of balance, which can be disturbed in situations of     uncontrolled stress. Sleep deprivation and specifically night shift is a source of stress     with adverse consequences on sleep, wakefulness, eating patterns and cardio-vascular     function. Furthermore, imbalanced autonomic profile is also associated with increased     inflammation, a known risk factor for cardiac problems, diabetes, and cancer.      Parasympathetic stimulation can control the inflammatory reaction, leading research toward     interventions which can stimulate the cholinergic pathway. Among these interventions, massage     therapy has shown to stimulate the PNS and bring back the balance within the body's organs.      Objectives:        1. To assess the physiological effects of night shifts on the ANS profile and bio-markers          of inflammation and stress in blood        2. To assess whether one session of massage therapy can revert the adverse effects of night          shift via re-balancing these components.      Methods:      A pilot prospective randomized crossover trial with 10 healthy hospital staff is in progress:      Each participants will be their own control. All participants will be measured for their     baseline characteristics and outcomes of interest on a regular working day as well as at the     end of 2 nights of shift work. At the end of one shift they will be randomly assigned to     receive a 30-minute-long upper body massage, while at the end of the other shift they will     receive a reading intervention which would serve as a control intervention. Randomization     is done using a computer system that also verifies inclusion-exclusion criteria before     allocating the intervention.      The autonomic profile is measured by spectral analysis of Heart Rate Variability (HRV)     captured by a state-of-the-art machine which non-invasively records electrical signals from     the body. The inflammatory markers in the blood are also measured using top-notch laboratory     technology.      The results of the study will be reported by comparing the outcomes of each subject with     their own baseline as well as comparing the two interventions for the effect of massage. Data     will be pooled for all subjects in order to show the overall effect.      The final results of this study will be used to plan stress management intervention trials.   "
79363|NCT02247076|"     The purpose of this study is to find out if meal timing affects calories burned and blood     sugar levels.   "
79364|NCT02247063|"     The investigators are doing a study to learn about the effects of a type of low-energy     non-surgical electrical brain stimulation (HD-tDCS) on chronic pain in people's jaw joints.     Disorders in these joints are called temporomandibular joint disorders, or TMD.   "
79365|NCT02247050|"     This pragmatic trial examines the uptake and effects of primary care clinician commitments to     follow 3 Choosing Wisely® recommendations. The investigators hypothesize that pre-encounter     invitations to clinicians to commit to the recommendations will decrease ordering of: (1)     imaging tests for low back pain, (2) antibiotics for acute sinusitis, and (3) imaging tests     for headaches. The study is a mixed-methods, stepped wedge cluster randomized trial in which     the intervention will be sequentially introduced to 6 clinics in southeastern Michigan in a     randomly assigned order.   "
79366|NCT02247037|"     This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as     a reliable model for treatment response for individual patients with triple negative breast     cancer. The collection of patient tumor tissue will also provide insight into the mechanisms     of therapeutic resistance for those individuals. Ultimately, this study will enhance our     understanding of the genomic basis for treatment response for triple negative cancer on an     individual basis, while having the potential to suggest new therapeutic options for high-risk     triple negative breast cancer patients with residual disease post neoadjuvant.   "
79367|NCT02247024|"     Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain     intensity, sedation score, and other side effects of opioids. Measurements of the     concentration of opioids and their active metabolites in blood.   "
79368|NCT02247011|"     This proposed study was designed to investigate the prevalence of a 5-year incident     osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D     (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the     Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit     of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and     examined.   "
79382|NCT02246829|"     Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for     patients suffering from neovascular age-related-macular degeneration.1 This early dramatic     reduction in CRT is already observed through week 4. Therefore it might be not necessary to     consistently perform each of the three monthly consecutive intravitreal injections of the     so-called loading phase.   "
79383|NCT02246816|"     MP-101 will be evaluated in this study to see if it is safe and tolerable.   "
79473|NCT02245646|"     This study aims at capturing for the first time at which frequencies and sound intensities     hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of     patients perceiving these sound distortions and the length of time over which the distortions     occur are assessed.   "
79369|NCT02246998|"     This study is to assess glomerular function before and during administration of stribild     (STB; elvitegravir [EVG]/cobicistat [COBI]/emtricitabine [FTC]/tenofovir DF [TDF]) or a     regimen containing TDF without COBI as ritonavir-boosted atazanavir (ATV/r) plus truvada     (TVD; FTC/TDF) or atripla (ATR; efavirenz [EFV]/FTC/TDF) compared to a regimen containing     neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual     glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and     estimated (calculated) glomerular filtration rate (eGFR). This study will assess tubular     function before and during administration of stribild, ATV/r plus TVD, or atripla compared to     a regimen of ATV/r plus ABC/3TC. This study will also evaluate the pharmacokinetics (PK),     antiviral activity, efficacy, safety, and tolerability of the three treatment regimens     through 24 weeks of treatment.   "
79370|NCT02246985|"     Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are     responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and     orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for     the human body as precursors of vitamin A. They are also thought to be important as     anti-oxidants and may help protect against cancer and heart disease. Although many foods are     rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed     and available for metabolism in humans.      Devising practical ways and means of increasing carotenoid bioavailability could lead to     better health outcomes. Processed foods are now widely eaten by many, both for their taste     and convenience. No studies have thus far looked at the bioavailability of carotenoids that     have been added into processed foods. Thus the purpose of this study is to investigate the     bioavailability of carotenoids that have been incorporated into processed food products     (bread and mayonnaise).   "
79371|NCT02246972|"     The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual     trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users.      The following hypotheses will be tested:        1. Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with          posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates          that are similar to existing Prolonged Exposure (PE) therapy delivered in military          samples (20-40%) and by the absence of any critical incidents.        2. Participants in the VRET group will show statistically and clinically meaningful          reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician          Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and          psychophysiological measures) following treatment.        3. Participants in the VRET group will show statistically and clinically meaningful          reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological          measures) compared to wait-list results.   "
79372|NCT02246959|"     In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and     cost-effectiveness of improving cholesterol levels among participants who are at high risk of     CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial     incentives. Participants will use electronic pill bottles that continuously monitor statin     adherence. The primary outcome will be change in LDL cholesterol over 12 months.   "
79373|NCT02246946|"     The purpose of this study is to determine if the addition of intermittent positive airway     pressure breathing (specific lung expansion technique) to conventional chest physiotherapy     chest drainage is effective to accelerate the reabsorption of pleural effusion and     consequently decrease the duration of chest tube drainage and respiratory system impairment.     These effects would decrease hospital stay lengths and the incidence of pulmonary     complications.   "
79374|NCT02246933|"     This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the     negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation     responses. Half of the participants will receive a high polyunsaturated fat diet )50%     carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty     acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the     other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50%     carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated     fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total     energy will be saturated fatty acids.) for 7 days.   "
79375|NCT02246920|"     This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been     designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray,     50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone     propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of     Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be     tested for superiority against a placebo nasal spray.   "
79376|NCT02246907|"     The purpose of this study is to evaluate the impact of an exercise intervention on     patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia     patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia     patients.   "
79377|NCT02246894|"     The main objectives of this study are:        -  to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand          therapy and dose at each bleed).        -  to assess clinical outcome when treating a bleed with Optivate®.        -  to evaluate Optivate® in terms of clinical tolerance and safety in children under the          age of 6 years. .        -  to assess FVIII inhibitor development during the study.   "
79378|NCT02246881|"     The main objective of the study is to compare the pharmacokinetics of Optivate® with the     subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary     objective is to compare the first and second pharmacokinetic assessments on Optivate® (and     recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and     safety.   "
79379|NCT02246868|"     The main objectives of this study are to compare the first and second recovery assessments     and recovery when a subject changed batch and to assess whether haemostasis was achieved with     Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical     tolerance and safety of Optivate®.   "
79380|NCT02246855|"     The main object of the study is to compare the AUC0-84, of a single intravenous infusion of     Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up     to 3mL/min and up to 6mL/min).   "
79474|NCT02245633|"     The aim of this research is to study how vitamin D affects various aspects of the disease     process, such as inflammation, coagulation (ADAMTS13 and WVF) and miRNAs, in Diabetic kidney     disease hemodialysis patients.      Diabetes mellitus (DM) is one of the most common chronic diseases in nearly all countries.     Diabetic kidney disease (DKD) traditionally has been referred to as diabetic nephropathy and     is one of the microvascular complications of diabetes. Diabetic kidney disease (DKD) occurs     in 25%-40% of patients with diabetes .      Some studies have shown that the high risk of cardiovascular disease in diabetic patients     with nephropathy is associated with increased plasma levels of von Willebrand factor (VWF)     and decreased ADAMTS13 levels. VWF is a glycoprotein that plays an important role in platelet     thrombus formation, whereas ADAMTS13 is a proteolytic enzyme that is responsible for     degradation of large multimers of VWF released in the plasma by endothelial cells and     platelets. Patients with both chronic kidney disease and diabetes have been shown to have     higher plasma levels of VWF and decreased ADAMTS13 activity compared to healthy controls.      Increased plasma levels of VWF, which reflects damage to endothelial cells and a     hypercoagulability state, have been reported in atherosclerosis and diabetes. Thus, VWF and     ADAMTS13 seem to be important players in the interface between diabetic nephropathy,     hypercoagulability and atherosclerotic cardiovascular disease. Vitamin D deficiency is a risk     factor for DM and hypertension. The investigators previous studies showed that adding     calcitriol (activated vitamin D) to endothelial and vascular smooth muscle cells     significantly down-regulated the inflammatory response of gene and protein expression     involved in the nuclear factor kappa-light-chain-enhancer of activated B cells (NFĸB) signal     transduction pathway. Micro RNA (miRNA) are short noncoding RNAs, 22-25 nucleotides long. As     an endogenous production transcript, miRNAs can bind to the 3 untranslated regions (3 UTR) of     its target messenger RNA (mRNA) in an imperfect, complementary manner, leading to     post-transcriptional gene silencing. As a result, miRNAs can inhibit gene expression via mRNA     degradation, translation inhibition, or transcriptional inhibition.The critical role of     miRNAs has been established in several cellular and biologic processes, such as     proliferation, differentiation, and development, and in the regulation of genes related to     immune responses, cancer, and insulin secretion. MiRNA are involved in various biological     processes and become novel biomarkers, modulators and therapeutic targets for diseases such     as cancer, atherosclerosis, and DM.      Significance: The high prevalence of cardiovascular morbidity and mortality in patients with     DM on chronic hemodialysis remains a significant clinical problem and the finding of     potential new biomarkers should be further investigated. This study aims to establish a link     between ADAMTS13, VWF miRNA expression and vitamin D levels that can contribute to the     development of new treatments for hemodialysis patients with diabetes.      Methods: Each hemodialysis patient with diabetes in the investigators institute will be asked     to participate in the study. After explaining the research goals, patients that agree to     participate will sign an informed consent. The investigators estimate that the study will     include 70 patients. Each patient will be assessed by a physician and 4 vials of blood will     be taken while the patient is connected to the dialysis machine. The blood will be sent to     the laboratory to check: 1) chemistry; 2) 1-25 vitamin D and 25- vitamin D levels; 3)     ADAMTS13 activity and VWF; and 4) miRNA extraction. The patients will be grouped according to     vitamin D levels (deficient /sufficient), and ADAMTS13, VWF and miRNA expression will be     compared between the groups.   "
79388|NCT02246751|"     Little is known about how children with cerebral palsy (CP) use their sensory systems (touch,     sense of body position, balance organs in the inner ear, vision) to help them achieve trunk     control for independent sitting. If a child with CP does not achieve trunk control by 4 years     of age their prognosis for motor skill development including walking is poor. Clinical     researchers at The Movement Centre in Oswestry, England have developed a method called     Targeted Training in which children train trunk control in small segments from the top down     using a custom fit training device. This study aims to examine how children with moderate to     severe CP use sensory information for trunk control before, during and after a program of     Targeted Training.   "
79389|NCT02246738|"     Purposes are to determine whether various cohorts of bladder cancer patients have detectable     tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see     if tCTC's provide novel information.Study population are various cohorts of patients     diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw, up     to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will be     collected at each blood draw.   "
79390|NCT02246725|"     In this trial, patients with cancer in the upper gastrointestinal canal who are going to     receive first line palliative chemotherapy and patients with colorectal cancer who are going     to receive second line palliative chemotherapy will be included. Participating patients will     be randomized between early contact with a palliative care unit, or contact with a palliative     care unit when needed. The objectives with the trial is to investigate if an early     establishment with a palliative care unit will have a positive impact on the patients quality     of life, this also applies for the nearest relative, survival, and if a difference in numbers     of chemotherapy cycles can be detected.   "
79391|NCT02246712|"     This study aimed to investigate the influence of uncontrolled type 1 and type 2 diabetes     mellitus (DM) on the kinetic disposition, metabolism and pharmacokinetics-pharmacodynamics of     tramadol enantiomers in patients with neuropathic pain. Thus, nondiabetic patients (control     group, n = 12), patients with type 1 DM (n = 9), and patients with type 2 DM (n = 9), all     with neuropathic pain and phenotyped as extensive metabolizers of cytochrome P450 2D6     (CYP2D6) who were treated with a single oral dose of 100 mg racemic tramadol were     investigated.   "
79392|NCT02246699|"     The prevalence of overweight and obesity is getting more and more important in developed as     well as in emerging countries. It can be defined according to the degree of fat storage by     measurement of fat mass.      No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a     fungal chitosan from the mycelium of non-genetically modified Aspergillus niger.     KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan.      The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical     device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body     weight reduction after 3 months of intake in overweight and obese men and women. Furthermore,     effects on anthropometric measurements, body fat mass percentage, serum lipids and safety     parameters will be investigated.   "
79393|NCT02246686|"     The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in     patients with mild to moderate ulcerative colitis in an acute flare.   "
79394|NCT02246673|"     This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic     (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to     febuxostat administered alone in adult subjects with gout.   "
79395|NCT02246660|"     The RESTORE trial will determine whether resveratrol supplementation can improve walking     performance in older people with lower extremity peripheral arterial disease (PAD).     Resveratrol, a polyphenol and natural supplement, specifically targets several impairments     associated with walking difficulty and mobility loss in people with PAD.   "
79396|NCT02246647|"     Our overall objective with this study is firstly to provide a comprehensive assessment of     intestinal permeability, mucosal barrier function using existing biomarkers and secondly to     explore novel biomarkers for measuring intestinal permeability in patients with constipation     predominant Irritable Bowel Syndrome (IBS-C).   "
79413|NCT02246426|"     This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled     clinical trial to assess the efficacy of an experimental software program targeting social     cognitive abilities versus a computer-based software control. Both the study and the software     being investigated meet the criteria of Non-Significant Risk.   "
79397|NCT02246634|"     Patients diagnosed with colorectal cancer routinely undergo a CT scan to identify whether the     cancer has spread to other parts of the body, but diagnosis of secondary cancer in the liver     is difficult using conventional CT. MRI is known to be better than CT at diagnosing cancer in     the liver but it takes a long time to do. Recently it has been suggested that limited MRI of     the liver can identify most cancer in the liver, however this has not yet been proven to be     effective in patients with a new diagnosis of colorectal cancer. The purpose of this study is     to test whether a quick MRI scan of the liver at the time colorectal cancer is diagnosed can     identify more cancer that has spread to the liver than conventional CT.      All patients who have been diagnosed with a high risk type of colorectal cancer but no liver     metastases on CT will be eligible to take part in the study.   "
79398|NCT02246621|"     The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors     (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be     randomized to abemaciclib or placebo in a 2:1 ratio.   "
79399|NCT02246608|"     This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure     Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the     wound prior to activating the NPWT.   "
79400|NCT02246595|"     The trial enrolls patients with early severe sepsis or septic shock displaying at least one     newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal     infection. The primary goal of the trial is to assess the pharmacokinetics and     pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and     tolerability as well as evaluate parameters of efficacy.   "
79401|NCT02246582|"     The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168     hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G     Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.   "
79402|NCT02246569|"     For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for     the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the     insertion of the coils distended lung sections shrink so that healthy parts can expand.      In the present study investigators intend to examine, whether the insertion of the coils     improves diaphragm function and force of the breathing muscles. Investigators hypothesize     that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves     breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.   "
79403|NCT02246556|"     This was a randomized, masked, controlled study of the effect of a virtual reality,     binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with     amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new     subjects for enrollment.   "
79404|NCT02246543|"     This study will have the primary aim to investigate within-day changes in appetite after     consumption of high-protein (HP, 30% of calories) and normal, or low, protein (LP, 15% of     calories) whey protein meal, in solid and liquid form, on appetite and ad libitum food     intake. Secondary objective will be to assess the statistical relationship between plasma     concentrations of gut hormones and visual analogue scales (subjective hunger and fullness)     and transit time.      In order to investigate the interaction of food structure and protein content on appetite,     this requires, in practice, either a differing amount (g) or calorie (kJ) load as a function     of energy density (defined as kJ/100g). Delivering the test meal as a solid and liquid form     gives an easy solution to achieve this manipulation without compromising the nutritional     profile. Following on from this decision, it is easier to produce different preloads using     whey protein (rather than meat protein), since it is easily incorporated into test meals.   "
79405|NCT02246530|"     The goal of this project is to identify an effective and conservative approach to treating     partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical     correction needed.   "
79406|NCT02246517|"     Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine     block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also     have antagonist property of NMDA receptors. The investigators hypothesize that prolonged     treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic     neuropathy, post herpetic neuralgia etc.).   "
79407|NCT02246504|"     The purpose of this study is to evaluate thyroid nodule's volume, structure and     vascularisation changes following HIFU therapy assessed by ultrasonography   "
79408|NCT02246491|"     This research is being done to better understand the causes of the disease     Ataxia-Telangiectasia and, in the longer-term, develop new therapies for the disease using     stem cells.      Induced pluripotent stem cells (iPSC) are a type of cells that can be made in the laboratory     from cells in your body, such as blood cells or skin cells (fibroblasts). These stem cells     can then be used for research purposes. For example, stem cells can be used to investigate     how the mutation in ATM causes the actual symptoms of Ataxia-Telangiectasia. In addition, the     stem cells can be used to screen for drugs that could be helpful to treat the disease or to     develop new laboratory techniques to correct the mutation that causes Ataxia-Telangiectasia.     where the mutation that causes the disease is corrected by the investigators. The stem cells     generated in this study will not be used directly for patient therapy and therefore this     research does not have a direct benefit to you. However, it will help advance our     understanding of the disease and develop future therapies.      Patients who enroll in this study will get all of the standard therapy they would get for     their tumor whether or not they participate in this study. There is no extra or different     therapy given. The study involves a one-time procedure (either blood collection or skin     biopsy).   "
79409|NCT02246478|"     The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in     patients with Duchenne Muscular Dystrophy.   "
79410|NCT02246465|"     The purpose of this study is to determine the effectiveness of RXI-109 in reducing the     recurrence of hypertrophic scar formation following elective revision of a pre-existing     hypertrophic scar.   "
79411|NCT02246452|"     The main objective of this study was the assessment of the nutritional status of children and     adolescents aged between 0-18 with malignancies based on BMI percentiles and standard     deviation scores, at diagnosis, during treatment and during a period of two years after the     end of therapy.   "
79414|NCT02246413|"     The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical     and cost effectiveness and implementation potential of a primary care integrated     multicondition intervention program to help improve mood and weight for obese adults with     clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation     added to the main trial with funding through the NIH common fund for the Science of Behavior     Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial     participants will be consented to undergo additional assays evaluating neurobiological     mechanisms of self-regulation.   "
79415|NCT02246400|"     The eCMP Pilot aims to study the feasibility and potential effectiveness of an     electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among     adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.   "
79416|NCT02246387|"     Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in     the investigators department and the Manchester operation the preferred procedure. The     investigators long-term reoperation rates for pevic organ prolapse are very low, as     documented in the investigators previous long-term follow-up study (Oversand et al,     International Urogynecology Journal 2013), however the data were retrospective and patients     with avulsions of the levator ani muscle were not identified. The investigators hypothesize     that correct fixation and elevation of the vaginal apex, as part of a three-compartment     repair procedure, is essential in the POP surgical repair, also when treating women with     levator ani avulsions.      The purpose of this study is to:        -  prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the          3-compartment Manchester procedure) gives an adequate elevation and fixation of the          vaginal apex.        -  assess changes in subjective symptoms between the preoperative evaluation and the 1 and          5-year postoperative evaluations.        -  evaluate whether the patients identified with levator avulsions in the investigators          population have an increased risk of failure (objectively and subjectively).   "
79419|NCT02246348|"     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler     ultrasound system incorporating a special signal processing package; i.e. the transthoracic     parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may     provide important insight into pulmonary blood vessels characteristics by the LDS signals     that are related to pulmonary hypertension.      The TPD performance in detecting PAH in SSc patients will be assessed in the study.   "
79420|NCT02246335|"     Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of     displaced femoral neck fractures in the elderly-elderly   "
79421|NCT02246322|"     Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and     effective technique for obtaining samples from the GI wall lesions and from organs adjacent     to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G.     Some studies have suggested that the 25G needle could be equal or even better than the 22G     needle.      The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for     testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles     types, 25G and 22G.   "
79422|NCT02246309|"     Embryoscopes, allow for embryo culture to be performed in an automated incubation system     under time lapse photography. Manufacturers of these systems (and investigators who have used     these systems) claim that the availability of 24-hour time-lapse photographic control     improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They     also claim that use of this system saves laboratory personnel time.      This study will randomize approximately 120 patients (60 in each arm) to standard embryo     culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time     spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.   "
79423|NCT02246296|"     Inpatient treatment for complicated severe acute malnutrition (SAM) continues to have a high     mortality in Africa. This is partly because children are commonly brought for admission     because they are seriously ill, rather than being brought to hospital because of malnutrition     alone. Mortality rates are especially high where SAM is complicated by HIV or TB. The early     phase of inpatient nutritional treatment for severe acute malnutrition is based on a     low-protein milk known as F75, which is given to improve metabolic homeostasis prior to the     re-feeding to achieve catch-up growth. F75 provides a high proportion of energy from     carbohydrates, including sucrose, lactose and maltodextrin. However, malabsorption of     different types of carbohydrates, but lactose in particular, is known to occur in SAM and may     lead to osmotic diarrhoea. Diarrhoea is common in children with SAM and is associated with     increased mortality. Furthermore, switching from a catabolic state to a high energy diet that     consists of predominantly carbohydrates can lead to 're-feeding syndrome' that may lead to     severe electrolyte abnormalities and multiple organ dysfunction.      The aim of this trial is to determine whether reducing the carbohydrate content of F75, and     removing lactose, improves the stabilisation of severely malnourished children. The trial     will involve randomising children who are eligible to receive F75 milk to either the current     formulation or a revised formulation. Both formulations will be given according to current     recommendations regarding frequency of feeding and caloric value. Since the purpose of F75 is     to stabilise the child metabolically and biochemically, the primary endpoint of the trial     will be time to stabilisation (the end of the first phase of treatment for severe acute     malnutrition). Blood and stool samples at admission and after three days will be used to     determine the effects on carbohydrate and fat malabsorption and evidence of the re-feeding     syndrome. Children will be followed up until discharge from hospital. The project has been     planned in consultation with the World Health Organisation (WHO) and, if the revised     formulation of F75 results in improved outcomes, will lead to a global change in     recommendations for its formulation.   "
79453|NCT02245906|"     The purpose of the study was to investigate how Brazilian fruits peel affect     acute/postprandial glucose and insulin responses, inflammatory markers, appetite control     peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue     scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a     standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers     in healthy volunteers, compared with a similar meal without the corresponding plant     materials.   "
80195|NCT02236208|"     The purpose of this study is to observe the effect of lack or excess of folic acid in first,     second and third trimester on child birth weight, fat content and the secretion of metabolism     related hormone, and clinical follow-up their offspring obesity.   "
79424|NCT02246283|"     The elderly demographic is on the rise - and this includes elderly living with schizophrenia.     Yet very little is known about their lives, how they cope with their condition and how it     develops over time.      Research in this patient-group is sparse; overall there seem to be a tendency for elderly     patients to manifest fewer psychotic symptoms and experiencing an increase in the     psychological quality of life with older age. Opinions are divided on the degree and extent     to which this tendency reflects remission and/or recovery in older patients.      In order to identify factors associated with a positive outcome we:        -  Investigate the course and the outcomes of the illness over the lifespan, as well as the          life course and outcomes.        -  Investigate the current status of mental and physical health, quality of life as well as          functional competence of elderly (55+ yr) with schizophrenia.      Also the investigators      - Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type     1 diabetes (a chronic somatic illness).      This study will yield vital insights into how schizophrenia develops over time, isolating     factors that determine how well patients fare. The perspective is to advance knowledge of     elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the     interventions offered to this group.   "
79425|NCT02246270|"     Urinary Tract Infections (UTIs) are the second most common infection in the body. UTIs     account for five percent of all visits to primary care physicians. Many women who have had a     UTI will develop recurring urinary tract infections. Recent studies suggest that some women     who suffer from recurrent UTIs have urinary tracts that allow bacteria to adhere to it more     readily than others. Women who suffered from bladder inflammation and recurrent UTIs were     noted to have reduced UTIs and bladder inflammation with heparin bladder instillations.     Heparin is a highly-sulfated glycosaminoglycan and stored within the secretory granules of     mast cells and released only into the vasculature at sites of tissue injury. It has been     proposed that, in addition to anticoagulation, the main purpose of heparin is defense at such     sites against invading bacteria and other foreign materials. The central question the     research is intended to answer is does Heparin bladder instillations decrease UTI rates in     patients.   "
79426|NCT02246257|"     The primary aim of our present study is to evaluate the effect of a targeted, intensified,     multidimensional intervention compared to conventional treatment of modifiable risk factors     for CVD in patients with early RA. The primary endpoint, a composite of death from     cardiovascular causes, non-fatal MI, non-fatal stroke and re-vascularisation, will be     assessed after 5years' follow-up.   "
79427|NCT02246244|"     Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in     France since 2002.      Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary     regarding the tumor localisation, the population, intensity of the symptoms...      Incidence of ENT cancer is highly significant in France, it is one of the most important in     the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of     depression is the most important (22%-57%).      Researches appears necessary to assessed the efficacy of antidepressant treatments with as     primary objective not only the decrease of depressive symptoms but also an ensemble of physic     and psychological symptoms.   "
79428|NCT02246231|"     Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both     ears. As a result of the tumours themselves or the treatment of the tumours, many patients     become profoundly deaf in both ears. It is possible to restore a degree of hearing by placing     a hearing implant in the brainstem adjacent to the hearing pathways within the brain. This is     termed an auditory brainstem implant (ABI).      The aim of this study is to find the optimum head position in relation to the MRI magnet     field, which would produce least area of image distortion in patients with ABIs. This will be     of benefit in optimising the MR imaging in future patients with implants.   "
79429|NCT02246218|"     This is an open-label study consisting of a transition period to RAVICTI, followed by a     safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI,     depending on age at enrollment. It is designed to capture information important for     evaluating safety, pharmacokinetics and efficacy in young children.      Subjects who are followed by or referred to the Investigator for management of their UCD.     Subjects eligible for this study will include patients ranging from newborn to < 2 years of     age with either a diagnosed or clinically suspected UCD.   "
79430|NCT02246205|"     The aim of the study is to compare the effect of Roux-en Y reconstruction (study group,     DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for     DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE     after pancreaticoduodenectomy.   "
79431|NCT02246192|"     The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the     healing process of the wound, when compared with the usual technique of daily local healing.     The investigators propose the objective of evaluating the efficacy of intra- and     postoperative application of plasma rich in growth factors, to reduce healing time and     complications, arising from its removal, compared to the standard surgical treatment.   "
79432|NCT02246179|"     The purpose of this study is to assess the efficacy of fractional CO2 laser assisted delivery     of topically applied anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml     solution and EMLA cream) regarding to anesthesia of the skin.   "
79433|NCT02246166|"     This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group,     single-dose study will assess the efficacy and tolerability of the active tablets versus     placebo in participants suffering from cold and influenza. Eligible participants will be     randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a     four-hour (hr) treatment phase. Each participant will be administered only once during each     study period. Participants will use a questionnaire to record the symptom severity scores as     described, as well as time.   "
79492|NCT02245399|"     The purpose of the study is to assess whether a Mediterranean-type weight-loss diet, enriched     with canola oil, high in plant protein, and low in carbohydrates will produce blood sugar     control, reduce coronary heart disease (CHD) risk factors and maximize weight loss, better     than conventional higher carbohydrate diets in overweight diabetic patients.   "
79493|NCT02245386|"     To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean     section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and     to study the effect of mode of delivery on female sexual function.   "
79434|NCT02246153|"     -  Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC)          has been supported by high-quality evidence, and the high-level evidence for advanced          gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG          0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence          of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer          (AGC).        -  China has entered the aging society since 1999. Among the GC patients in China, the          average age is 65 years old, which makes increasing attempts to explore laparoscopic          techniques in the treatment of elderly patients.        -  Nowadays, a considerable proportion of elderly patients suffer from multiple diseases,          such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative          and postoperative complications can not be ignored. Unfortunately, there are rare          studies specializing into the LAG for the GC patients of > 65 years old.        -  Accordingly, the comparison of intraoperative and postoperative complications between          laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with          gastric cancer based on a randomized controlled trial is warranted.   "
79435|NCT02246140|"     There is an association between intracranial arterial stenosis and ischemic stroke in young     adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis     in asymptomatic regular resin of cannabis users in comparison with control subjects.   "
79436|NCT02246127|"     The purpose of this study is to elucidate which sequence of streptozotocin (STZ) based     chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better     results in terms of second Progression Free Survival (PFS) in well differentiated and     advanced pancreatic NETs.   "
79437|NCT02246114|"     Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant     women. Investigators hypothesize that more regular self-monitoring, text messages and     feedback as provided by home carbon monoxide monitoring device combined with medical feedback     on results will reduce smoking during pregnancy compared to only receiving text message and     no self-monitoring by home monitoring device and no feedback by home carbon monoxide     monitoring device . The periconceptual period is a life period, where given the immediacy of     the fetus and future child, a pregnant woman is willing to try and modify potentially harmful     behaviors.   "
82060|NCT02211859|"     Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile     of BI 2536. Assessment of safety and efficacy.   "
79438|NCT02246101|"     Environmental toxins exert damaging health effects in workers. Thousands of responders who     worked or volunteered on the World Trade Center (WTC) rescue and recovery effort following     the September 11, 2001 attacks suffer from health conditions or may be at increased risk for     worsening health. In a pilot study, investigators identified the first evidence of kidney     damage in subjects with very high exposure at Ground Zero. Specifically, noted was a     preliminary association between the intensity of particulate matter exposure and albuminuria,     a marker of early chronic kidney disease (CKD), systemic endothelial dysfunction, and     increased cardiovascular risk.      The long-term goal is to minimize the risk of CKD and cardiovascular disease (CVD) among     individuals exposed to inhaled toxins. The primary objective of this research is to quantify     the risk of kidney damage among first responders to the WTC attack and to determine the     relationship to particulate matter exposure as well as determine an association between renal     and cardiovascular damage in first responders and to explore potential mechanisms. The     central hypothesis is that exposure to inhaled particulate matter causes systemic     inflammation and endothelial dysfunction that result in chronic kidney and cardiovascular     damage. This hypothesis will be investigated in a subgroup of participants from a previously     conducted NIOSH-funded study Pulmonary Function Abnormalities, Diastolic Dysfunction and WTC     Exposure: Implications for Diagnosis and Treatment (WTC-CHEST, PI Mary Ann McLaughlin).      The proposed study will capitalize on unique resources in WTC-CHEST, including the     standardized collection of data on particulate matter exposure and shared risk factors for     CKD and cardiovascular disease, and cardiopulmonary function testing. The output from this     proposal is anticipated to have a broad impact on understanding the health effects of inhaled     particulate matter.   "
79439|NCT02246088|"     Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great     disability and significant healthcare costs. Substantial scientific evidence indicates a role     for central sensitization in OA pain. Reconceptualization of pain through Neuroscience     Education (NE) is an intervention that has already been used successfully in some chronic     musculoskeletal pain conditions characterized by alteration on CNS pain processing or central     sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and     chronic whiplash associate disorders).There is compelling evidence that NE have a positive     effect on pain, disability, catastrophization and physical performance for chronic     musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are     essentially lacking.      The primary aim of this study is to assess the effect of NE on pain, disability and physical     performance in subjects with chronic OA knee pain waiting for replacement surgery. This will     be the first time NE will be addressed specifically to OA pain. To investigate the benefits     of NE on pain related to knee OA, the effect of a manual therapy intervention combined with     NE (MT+NE) will be compared with this same manual intervention plus an educational program     based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary     aims will be addressed as well:        -  Examining the effects of the two interventions on the mechanism of central sensitization          in patients with knee OA;        -  Examining the effects of the two interventions on pain catastrophizing, illness          perceptions and kinesiophobia in patients with knee OA;        -  Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.   "
79440|NCT02246075|"     The purpose of this study is to evaluate the safety of 2 fixed doses of EVP-6124     hydrochloride (HCl) compared to placebo for 24 weeks in subjects with mild to moderate     Alzheimer's disease who are concurrently receiving stable treatment with memantine and     currently receiving stable treatment or previously treated with an acetylcholinesterase     inhibitor.   "
79454|NCT02245893|"     This study evaluates fracture healing, anatomic reduction and return to functioning in     patients with unstable Weber C type fractures of the ankle. Best outcomes are obtained when a     good alignment of the ankle joint is maintained and natural function of the syndesmosis     (space between the tibia and fibula bones) is restored. The syndesmosis and ankle joint is     stabilized by a series of ligaments which are often damaged in Weber C type fractures.     Current syndesmosis repair techniques traverse the tibia and fibula, but do not anatomically     reconstruct the ligaments. The investigators will compare reconstruction of the unstable     syndesmosis by open reduction and internal fixation using a syndesmosis screw coupled with     anterior ligament (AiTFL) anatomic repair technique (ART) to percutaneous repair using a     syndemosis screw only (SCREW). Radiographic, pain and functional outcome scores will be     compared between the groups using validated outcome measures.   "
84450|NCT02180646|"     This study examined the effect of a high protein or high carbohydrate breakfast on the     glucose and insulin response following the breakfast meal, as well as the subsequent response     following the lunch meal.   "
79441|NCT02246062|"     Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience.     Among the strategies for reducing children's anxiety, non-pharmacological strategies are as     important as the pharmacological ones, but their its validity is still controversial.      Objectives: The aim of this study is to verify if the information provided to relatives as     well as and smartphone application provided to children interferes in prevalence and level of     child preoperative anxiety.      Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical     procedures and their relatives are randomly allocated into four groups: control group (CG)     where the relative received conventional information about anesthesia; info group (IG),     relative received an information leaflet about anesthesia; device group (DG), relative     received only conventional verbal information and the child received smartphone application     immediately before entering the operating room; device and info group (DIG) relative received     a leaflet containing information and the child received smartphone application. Children's     anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three     occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating     room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for     prevalence and level of anxiety in the groups.   "
79442|NCT02246049|"     The purpose of this study to assess efficacy and tolerability of combination therapy     FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic     colorectal cancer.   "
79475|NCT02245620|"     This study will be a Phase 2, randomized, double-blind, placebo-controlled study, enrolling     40 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether     the administration of MTP-131 will change either hand skeletal muscle energetics or muscle     performance in age-related skeletal muscle mitochondrial dysfunction.   "
79476|NCT02245607|"     This is a randomized study to compare Compensatory Cognitive Training (CCT) versus     Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.      Study hypotheses: Compared to those who receive RT, study participants receiving CCT will     show significant improvement in neurocognition, functional capacity, self-rated functioning     and clinical measures.   "
79443|NCT02246036|"     For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very     common complication yielding high morbidity and mortality. Inadequate regional perfusion of     certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS.     Current practice uses cardiac output data and blood pressure to manage shock but there are     still lacks of information about the regional perfusion. This leads to late MODS diagnostics     preventing the implementation of adequate treatment.      Gut perfusion monitoring seems to be a good target to assess the microcirculation but,     nowadays, no practical methods or devices are available to measure the gut perfusion, and the     current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).      MC Monitor trial is a prospective, multi-center pilot study, enrolling 10 patients.      The probe will be used by intensivists on ICU patients with a risk of shock and requiring     mechanical ventilation.      The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist     (standard procedure for post-pyloric tubes placement). This procedure will be used to assess     the status of the gut mucosa prior to the placement of the APD probe.   "
79444|NCT02246023|"     After randomization, the subjects undergo flexible bronchoscopy either with fractionated     propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate,     oxygen saturation, and oxygen requirement are measured continuously during the procedure and     thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted     continuously during and after the procedure.   "
79445|NCT02246010|"     The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea     duration and decrease its severity in formula-fed infants presenting to the Emergency     Department (ED) or pediatric clinics with acute diarrhea.   "
79446|NCT02245997|"     The purpose of this study is to give 12T a smaller dose of radiation in order to decrease     these late side effects.   "
79447|NCT02245984|"     Compare the clinical competence of undergraduate nursing students' of mashhad nursing and     midwifery school in two groups applying nursing process (paper- based versus electronic).   "
79448|NCT02245971|"     Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc     resection of superficial tumors in the gastrointestinal tract. ESD, however, is a     time-consuming procedure that requires a high level of endoscopic skill to achieve a     desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of     lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent     position, irrigated water and blood may prevent visual field of ESD.      Generally, whole precutting around the lesion during the ESD is performed prior to     dissection. However, it is expected that partial precutting method for the lesion located in     the antrum of the lesser curvature may improve the visibility of ESD because it can help us     the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time     of ESD for the lesion located in the antrum of the lesser curvature according to the     precutting methods (whole precutting vs. partial precutting).   "
79449|NCT02245958|"     This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins     BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of     Cervical Dystonia and Blepharospasm in clinical practice.   "
79450|NCT02245945|"     The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel     in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24     regimen.   "
79451|NCT02245932|"     The overall objective is to investigate the efficacy of resveratrol in modulating metabolism     and CVD risk profile in patients with COPD. The primary objective is to investigate the     effect of resveratrol on CRP as clinical marker of low grade systemic inflammation. The     secondary objective is to investigate the effect of resveratrol on body composition,     inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a     comprehensive assessment of metabolicand physical performance profile known to be affected by     low grade systemic inflammation and by resveratrol.   "
79452|NCT02245919|"     Up to now, only little research has been performed in tailoring treatment of patients with     chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial     intervention in patients with a moderate to high level of disability and in whom the     contributing role of psychosocial factors to this disability is mild to moderate (WPN3-).     Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary     rehabilitation settings but might also benefit from treatments based on these     multidisciplinary rehabilitation treatment principles when provided by specifically trained     primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the     feasibility of a specifically for primary care physiotherapist developed biopsychosocial     intervention (Back on Track intervention) in WPN3- classified patients, and to evaluate     whether this Back on Track intervention results in a significant improvement in functional     disability in this subgroup of patients.   "
79455|NCT02245880|"     Intubation must be done with utmost care in cervical trauma patients. cervical spine motion     must be minimized and intubation must be fast. The aim of this study was to compare the     effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients     undergoing elective surgery were enrolled in this trial. After standard monitorisation     including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with     propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were     divided into two groups glidescope and fastrach. Rigid collar was placed then patients were     intubated with one of these devices. Mask ventilations with or without collar were recorded.     insertion times, intubation times of the devices were recorded. Peroperative hemodynamic     parameters and postoperative minor complications were also recoded.   "
79510|NCT02245165|"     The aim is to elucidate how NO works in conjunction with other neurotransmitters to regulate     the migrating motility complex (MMC). Twenty-two healthy volunteers should undergo     water-perfused antroduodenojejunal manometry during a control period of 4 h, followed by     another 4h after a bolus injection of either saline or the NO synthase inhibitor     NG-monomethyl-L-arginine (L-NMMA, 10 mg/kg intravenously) with or without atropine (1 mg) or     ondansetron (8 mg). Effects on the MMC pattern are determined. Exhaled and rectal NO is     monitored throughout the experiments. Effects of L-NMMA on the MMC pattern are analyzed     against a background of atropine or ondansetron. Blood samples are drawn for analysis of     simultaneous peptide hormone release into the bloodstream. Peptide hormone release will be     correlated to the respective motility pattern elicited by LNMMA.   "
79456|NCT02245867|"     The purpose of this study is to examine the tolerance, safety, pharmokinetics, and possible     clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive     chimeric (Ch) IgG1 mAb 11-1F4 in patients with amyloid light-chain (AL) amyloidosis.      The phase 1a part will involve at least 3 patients and a maximum of 18 patients. The first     patient will receive the starting dose of the antibody and, if tolerated, the following     patients will each receive (if tolerated) progressively higher doses of the antibody.     Patients in part 1a of the trial will receive only one infusion of the drug. Patients treated     in the phase 1a part receive lower dosage which might not be effective.      Once the maximal tolerated dosage is established during the phase 1a part, the investigators     will accrue patients to the phase 1b part of the trial. Patients will receive 4 infusions,     once each week for 4 weeks. Patients who were treated in the part 1a of the trial and showed     no toxicity can be also treated in the part 1b of the trial. The first patient will receive     the starting dose of the antibody and, if tolerated, the following patients will each receive     (if tolerated) progressively higher doses of the antibody. When the investigators reach the     maximum tolerated dose without toxicity, the investigators e will enroll another 4 patients     to receive the same dose. If there are no toxicities, another 4 patients will be treated at     the next dose level, and so forth. Patients treated in Phase 1b may receive lower dosages     which might not be effective. The goal of Phase 1b is to establish the tolerance and possible     beneficial effects of 11-1F4. If successful, treatment with this antibody would represent a     novel approach in the care of individuals with AL amyloidosis.   "
79457|NCT02245854|"     Colorectal cancer is a major cause of morbidity and mortality in Western countries.     Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC     incidence and mortality.      Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel     perforation, so that a careful balance between efficacy and safety appears to be clinically     relevant.      Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions,     which represent over 90% of all the polyps.      To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy     techniques - i.e. without electric current - by means of biopsy forceps or snare, have been     proposed.      Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of     electrocautery may result in an increased risk of bleeding. The safety of cold-snare     polypectomy has however been recently shown in controlled trials.      Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have     assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual     disease), and no studies have compared it to conventional polypectomy.      The investigators perform this study to assess both the efficacy and safety of a novel snare     (Exacto™) for polyp removal.   "
79458|NCT02245841|"     This study will assess the safety and efficacy of H.P. Acthar gel for treating the cutaneous     manifestations in patients with refractory classic dermatomyositis, juvenile dermatomyositis,     and amyopathic dermatomyositis. Our hypothesis is that H.P. Acthar gel will be both safe and     effective for such patients.   "
79459|NCT02245828|"     This is a double blind, randomized, placebo controlled, single and multiple ascending dose     study in healthy subjects. Safety evaluation will include (serious) adverse events, vital     signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be     drawn at specified timepoints.   "
79460|NCT02245815|"     The purpose of this study is to evaluate the incidence of necrotizing enterocolitis and its     effect over the secreting immunoglobulin A in the feces with the use of probiotics of the     strain Boucardii vs. Multispecies in premature newborns weighting less than 1500 g.   "
79461|NCT02245802|"     This study aimed to validate CU prediction model on mortality for patients with high risk     bleeding peptic ulcers after therapeutic endoscopy.   "
79462|NCT02245789|"     Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic     induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a     conventional MacIntosh laryngoscope.      Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a     videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that     it modifies the anesthetic drugs requirement. .   "
79463|NCT02245776|"     The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in     incurable neurological disorders.   "
79464|NCT02245763|"     The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world     outcomes related to the transcatheter mitral valve repair and replacement (TMVR) procedure.     Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology     (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure     for the treatment of mitral valve disease.   "
79465|NCT02245750|"     In the current study the investigators hypothesize that Routine Hysteroscopy prior to     IVF/ICSI cycle increases the clinical pregnancy rate.   "
79466|NCT02245737|"     The purpose of this study is to assess the efficacy and safety of lanabecestat compared with     placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study     will test the hypothesis that lanabecestat is a disease-modifying treatment for participants     with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive     impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of     the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease     Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2     lanabecestat treatment groups compared with placebo.   "
79470|NCT02245685|"     This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of     the plan underlines the need to improve practices and access to opioid substitution     treatment. Priority 3 stresses the importance of articulation and coordination between     specialized structures and community medicine to optimize the quality of care and to ensure     continuity in the followup of these patients. This study focuses on the followup of patients     under substitution therapy from the moment they enter a specialized care center for addicts     to the period they are monitored by a general practitioner outside the specialized care     center. The assessment described in this study should allow to harmonize and keep a     continuity in patient monitoring.   "
79471|NCT02245672|"     The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when     administered by inhalation in adult asthma patients   "
79477|NCT02245594|"     In this study we would like to clarify the effect of long lasting Crohn's Disease on motility     of the gastrointestinal system in patient and the effect regarding sleep disturbances. This     will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica,     Schweiz) and the well known polysomnographic equipment.      Our hypothesises are:      Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have     abnormal colonic transit (primary endpoint).        1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms          have abnormal gastric emptying and small intestinal transit (secondary endpoints).        2. Total and segmental transit times found in patients with CD will be compared with          corresponding transit times in healthy volunteers found in a previous study.        3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.        4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or          colonic CD in remission and sleep disturbances.   "
79478|NCT02245581|"     Patient characteristics, duration of surgery, and infusion volumes will be compared between     the groups. Oxygen transport and organ function will be compared Length of hospital stay,     morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed     using the student t-test and discrete variables will be analyzed using Chi-Square test.     P-value <0.05 will be considered significant, where appropriate 95% confidence intervals will     be calculated. Statistical analysis will be carried out using standardize statistical     programs SPSS 12.0 for windows.   "
79479|NCT02245568|"     The purpose of this study is to provide subjects who have completed participation in a Phase     2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term     safety of TRx0237.   "
79480|NCT02245555|"     Study to describe Tamsulosin prescription characteristics in a representative population of     patients on treatment for benign prostatic hyperplasia   "
79481|NCT02245542|"     Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS®     -treatment with special respect to nocturia   "
79482|NCT02245529|"     The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving     patients treated with Secotex® (Tamsulosin) in real life settings. The aim of a PEM is to     monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic     Hyperplasia as used in general practice   "
79483|NCT02245516|"     The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25%     ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal     fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.   "
79484|NCT02245503|"     The objectives of this post marketing surveillance study were to document the comorbidity and     comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign     Prostatic Hyperplasia).   "
79485|NCT02245490|"     Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity     in patients with LUTS suggestive of BPH and relevant storage symptoms   "
79486|NCT02245477|"     In this study we explore To explore the role of maternal serum vascular endothelial growth     factor (VEGF) in pregnancies complicated by foetal growth restriction.   "
79487|NCT02245464|"     The objective of this PMS study was to monitor and assess the safety of Micardis tablets in     patients with hypertension over a period of 6 years   "
79488|NCT02245451|"     The primary objective of this study is to characterise the effects of tipranavir 500 mg and     ritonavir 200 mg (TPV/r; given twice daily) at steady-state on the pharmacokinetics of     methadone administered as a single dose in healthy adult volunteers   "
79489|NCT02245438|"     Study to characterize the effects of two dose combinations of Tipranavir (TPV)/Ritonavir     (RTV) (TPV 750 mg/RTV 200 mg and TPV 500 mg/RTV 100 mg), administered twice-daily, on the     pharmacokinetics of Norethindrone-Ethinyl Estradiol (NET/EE) 1 mg/ 0.035 mg administered as a     single dose.   "
79490|NCT02245425|"     This study is designed to compare the short-term effects of two different thoracic spine     thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in     people with neck pain.      The null hypothesis is that there will be no differences between the two manipulation     techniques for short-term effects on neck range-of-motion, pain, and self-reported disability     in people with neck pain.   "
79494|NCT02245373|"     Major Depression (MD) is highly prevalent and has associated a high burden and economic     costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).      Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by     NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.      Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC     center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring     (n=150) and B) pharmacological treatment (n=150).      Patients will be followed-up for one year and data will be collected at baseline, 6 and 12     months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life     with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version of     the Client Service Receipt Inventory (including lost productivity).      Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping     replications will be conducted to asses uncertainty. Cost-acceptability curves will be done     using two perspectives: the National Health Service perspective and the Societal perspective.      The Propensity Score technique will minimize the absence of randomization, matching cases     from both treatment options.   "
79495|NCT02245360|"     To investigate the immunologic effects and safety of 60-day treatment of the Standardized     Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass     pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.   "
79496|NCT02245347|"     Drug resistant tuberculosis is a growing problem world wide. The current methods for     diagnosis are time consuming and may delay diagnosis and treatment for many weeks. In this     study the investigators wish to take sputum samples from patients to see if the investigators     can validate a molecular DNA based process for prompt identification of drug resistant     tuberculosis. The investigators wish to extract and amplify DNA from drug resistant     tuberculosis and identify genes within it that confer resistance.   "
79497|NCT02245334|"     To assess the effect of povidone-iodine on infectious complication rate caused by transrectal     prostate biopsy   "
79498|NCT02245321|"     The prevalence of iron deficiency in blood donors has been demonstrated to be a direct     consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is     priority to implement programs to remediate iron deficiency issues associated with blood     donations. To explore this issue, the study's aims to:        1. Determine whether regular blood donors provided with accurate information about their          iron status and written recommended courses of action will take steps to          prevent/mitigate iron deficiency on their own without being given iron supplements by          the blood center; and        2. Determine if two different amounts of iron provided by the blood center will          prevent/mitigate iron deficiency in regular blood donors.      To conduct this randomized, placebo controlled study, participant donors will be assigned to     one of two arms and followed for a 24 month period. Each subject will provide additional     blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin     (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.      Under the two study arms, subjects are to be randomized into one of the following five     blinded categories:        -  Receive a thank you letter after each blood donation.        -  Receive a letter informing them of their ferritin result at each visit, along with          recommendations for blood donation.        -  Receive pills to take daily that contain no iron (a placebo or inert pill).        -  Receive pills to take daily that contain 19 mg of iron (the typical amount in a          multivitamin with iron).        -  Receive pills to take daily that contain 38 mg iron (the typical amount in an          over-the-counter iron supplement).   "
79499|NCT02245308|"     The goal of this research study is to examine the effects of a treatment for helping homeless     veterans who smoke to stop smoking. Participants in the study will be assigned to one of two     study groups. Participants in the first group will be referred to the local Department of     Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group     participants will receive a behavioral treatment designed to reward smokers for quitting and     staying quit. These participants will also receive telephone counseling and medications for     smoking cessation.   "
79500|NCT02245295|"     There is a paucity of data concerning the impact of the sedation technique used for     endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic     accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA     in deep and moderate sedation, and to investigate other possible determinants of diagnostic     accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).      The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for     selective sampling in deep sedation are compared with the first consecutive patients in     moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with     those on surgical or radiological follow-up.   "
79501|NCT02245282|"     Prostate cancer detection and disease progression monitoring relies on systematic multi-core     biopsies. Minimal invasive imaging capacities for lesion targeting and monitoring are badly     needed. The purpose of this study is to determine if a new MRI technique can identify and     monitor prostate disease progression. If so biopsy core number can be reduced to as small as     one, and frequency for biopsy repeat can be reduced. The new technique is about a new way of     analyzing the pictures taken as part of prostate MRI exam. This part is called dynamic     contrast-enhanced MRI. It involves an injection of contrast reagent (or dye) through the arm     vein during a time period when prostate MRI pictures are continuously taken.   "
79502|NCT02245269|"     Study to determine the effects of combined tipranavir and ritonavir treatment (at     steady-state) on the single-dose pharmacokinetics of atorvastatin, the effects of single-dose     atorvastatin on the steady-state pharmacokinetics of tipranavir, and the effects of antacid     on the pharmacokinetics of tipranavir   "
79503|NCT02245256|"     To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative     delirium in liver transplant patients in the ICU.      Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of     dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia     for liver transplantation and continued until 48 hours after surgery.      Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.   "
79504|NCT02245243|"     The purpose of this study is to evaluate the pharmacokinetic profile, safety, and     tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and     subjects with mild, moderate, or severe hepatic impairment.   "
79505|NCT02245230|"     The purpose of this study is to better understand the cardiovascular effects of the     vasodilatory peptide Angiotensin (1-7) in human hypertension. In this study, the     investigators will test the hypothesis that systemic Angiotensin (1-7) infusion produces     negligible effects with intact baroreceptors, and that the cardiovascular effects of this     peptide are unmasked following elimination of baroreflex buffering.   "
79506|NCT02245217|"     Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer   "
79507|NCT02245204|"     The purpose of this study:      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics     characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the     advanced malignant tumor subjects;   "
79508|NCT02245191|"     It is a prospective clinical trial with random distribution that intends to investigate     maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean     delivery in patients with pre-eclampsia.   "
79509|NCT02245178|"     Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the     United States, but markers that predict risk of developing disease outside of cigarette     smoking have not been identified. Individuals with lung disease frequently have concurrent     cardiovascular disease, but the reason for this is not well understood. In this study, we     will identify markers that predict risk of future lung disease and evaluate the concurrent     subclinical evolution of lung and heart dysfunction. This will allow for targeting of     preventive strategies to stop the rising incidence of COPD and other lung diseases and     provide insights into why heart and lung disease frequently occur together.   "
79825|NCT02241070|"     The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas     a workplace health promotion program on psychological distress, prolonged fatigue, job strain     (job control and job demand), and perceived stress and to explore the influences of personal     characteristics (including gender, age, education, and occupation) on the outcomes of the     intervention with time.   "
79511|NCT02245152|"     Globally, child undernutrition is the underlying cause for 3.1 million deaths of children     younger than 5 years. 18.7 million children under five years of age suffer from severe acute     malnutrition (SAM) and an additional 33 million children suffer from moderate acute     malnutrition, and are at risk of developing SAM      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute     malnutrition and programs that focus on the prevention of acute and chronic undernutrition -     resulting in many missed opportunities for using prevention platforms to screen and refer SAM     children, or for using screening and referral platforms to provide prevention services.      This project will address two critical gaps related to the integration of preventive and     treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically     integrated into routine health-center visits or mainstreamed into community outreach     programs; and 2) screening programs often do not offer any preventive services for those     children found not to be suffering from MAM/SAM at the time of screening; mothers of children     identified as non-MAM/SAM case are usually sent home without receiving any health or     nutrition inputs and as a result, may fail to come back for screening because they do not see     any tangible benefit associated with their participation in the screening. This project will     specifically address these gaps by assessing the effect of an integrated approach consisting     of higher screening coverage and preventive Behavior Change Communication (BCC) +     Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment     of child undernutrition.   "
79512|NCT02245139|"     Acute gastroenteritis is a common cause of hospital admission and health office visits and     have a huge burden on the economy of developing countries. The investigators proposed this     observational prospective study during summer period in a community and tertiary care     hospital in a rural area of Lebanon to investigate the etiologies and age distribution of     admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.   "
79513|NCT02245126|"     Using routinely collected data to compare different concentrations of locally applied     anaesthetic drugs and determine which concentrations give better pain control during     voluntary medical Male circumcision.   "
79514|NCT02245113|"     This study will be comparing human body responses by the effects of diets cooked with     NoveLin, virgin olive oil and RBD coconut oil.   "
79515|NCT02245100|"     This pilot research trial studies circulating tumor deoxyribonucleic acid (DNA) in predicting     outcomes in patients with stage IV head and neck cancer or stage III-IV non-small cell lung     cancer. Studying circulating tumor DNA from patients with head and neck or lung cancer in the     laboratory may help doctors predict how well patients will respond to treatment.   "
79516|NCT02245087|"     The purpose of this study is to determine whether pharmacologic lowering of low density     lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate     or markedly reduce the composite endpoint of incident all cause mortality, myocardial     infarction, stroke or coronary revascularization.   "
79524|NCT02244983|"     It is the investigators goal to identify the prevalence of underlying diseases, make     disposition more rational, and establish risk stratification tools in elderly patients     presenting with falls. Additionally, the outcome of standard care (clinical assessment only     for disposition) will be compared with a new approach combining the standard of care with     biomarker assisted disposition of elderly patients presenting with falls. Therefore the     investigators are looking at the following points.      Emergency department work-up        1. Prevalence of underlying disease        2. Developing algorithms for initial assessment Disposition      a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b.     Comparing geriatric emergency assessment to standardized disposition planning   "
80002|NCT02238730|"     To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral     electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the     treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral     electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.   "
79517|NCT02245074|"     -  Background: Infantile asthma is composed of various phenotypes, however the definition          is still based on the clinics. Namely, the infants could be classified as transitory,          peristent or late and persistent asthma. Some risk factors for the persistent asthma          phenotype are recognized as atopy. However all peristent asthma are not related to          atopy. Regarding the pathophysiology, little is known on airways inflammation in these          infants, and the current data are mostly based on the BAL analyses, or on biopsies.          Consequently, BLA and biopsies should be justified by the need of an indicated          fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion          could be also collected after hypertonic saline induction and chest physiotherapy. This          method has been validated in the children, but has not in the younger.        -  Aim : Analyses of cell profiles regarding the severity of infantile asthma.        -  Methods : This descriptive study compared 3 groups of infants, the first with acute          exacerbation, the second with uncontrolled asthma and the third with controlled asthma.          Accounting 25% of failure, the number of 40 infants per groups has been calculated. The          sputum induction will be performed by repeated nebulizations of 3% saline hypertonic          solution. Cellularity and cell profiles were analysed as previously recommended. Safety          will be evaluated.        -  Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of          wheezing during the 2 first years of life), aged between 6-12months.Asthma control was          evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was          aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled          asthma was defined whether the infant presented any symptoms during the last 4 weeks.          Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.        -  Feasibility : A preliminary study has been presented in the Vienna ERS congress.   "
79518|NCT02245061|"     The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy     presurgical assessment frequently requires intracranial recordings like     stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is     commonly used during SEEG for functional mapping or to induce seizure.      However, the recording of seizures is sometimes insufficient to circumscribe the EZ and     development of new biomarkers is necessary.      The cortex within the EZ is thought to be hyperexcitable. The paired pulses paradigm, using     transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical     excitability level. The investigators hypothesize that paired pulses DES during SEEG could     provide useful information for EZ identification.   "
79692|NCT02242799|"     Malaria and HIV are found in the same regions of the world and developing countries are most     affected by both diseases. For malaria, new drugs have been introduced called ACTs. These     drugs are effective against malaria but little is known about how the levels of these drugs     in blood relate to how effective these drugs are. For HIV, a new drug has been developed     called dolutegravir which has potential to be widely used in developing countries. This     proposal will explore how dolutegravir affects the drug levels of these antimalarial drugs     and vice versa. In total, 46 healthy volunteers will participate in this study.   "
79519|NCT02245048|"     The purpose of this research study is to determine if carotid artery ultrasound scanning can     provide additional information for determining cardiovascular risk in patients.      Patients who agree to participate wil undergo non-invasive carotid intima-media thickness     (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of     patient standard of care stress echocardiogram (SE) and of diastolic function.      We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications,     CIMT and plaque assessment will provide useful risk stratification beyond use of traditional     risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise     capacity and 3) Exercise capacity will correlate with diastolic function.   "
79520|NCT02245035|"     The purpose of this study is to learn if dairy food consumption may help brain health in     aging by protecting nerve cells from oxidative damage.   "
79521|NCT02245022|"     Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women      Rationale: In developing countries many women present with a new HIV diagnosis in late     pregnancy, and are at high risk of transmitting infection during delivery. Moreover, women     may acquire NNRTI resistance from primary transmission, or use of nevirapine (NVP) in     previous pregnancies. In these circumstances, DTG is likely to be more effective in reducing     mother to child transmission of HIV than NNRTI-based regimens.      Study design: HIV positive pregnant women presenting with untreated HIV infection in late     (≥28 -36 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily)     or standard of care (nevirapine or efavirenz) + 2 NRTIs. PK (0-24h) profile will be sampled     in third trimester and post-partum.      Although this is primarily a PK study (and has been powered as such) randomisation is     included to allow comparison of plasma HIV VL responses against standard of care (NVP or EFV)     and is essential for evaluation of secondary endpoints of safety and efficacy of DTG in     pregnancy.      Number recruited N=30 per group   "
79522|NCT02245009|"     Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac     rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators     (ICD). External electrical cardioversion is an established method to achieve rhythm control     (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and     efficacy of external electrical cardioversion in patients with cardiac rhythm management     devices exists. Thus, available data on the safety of external electrical cardioversion in     cardiac rhythm management patients lacks statistical power to accurately reflect the true     hazard of external electrical cardioversion in patients with cardiac rhythm management     devices.      The aim is to systematically include and follow all patients with cardiac rhythm management     devices presenting for external electrical cardioversion, to analyse the effects of external     electrical cardioversion on leads and devices.   "
79523|NCT02244996|"     Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB)     treatment on retinal functions, especially the cone function, and retinal structure in     patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial      Setting: Primary Care clinical trial      Participants: 120 RP subjects will be recruited from Ophthalmology department at The     University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly     allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1     year. After the 1st year, both groups will stop the treatment and all subjects will also have     the same eye exam in 6-month period for the 2nd year.      Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4     programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave     amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct     component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual     acuity.      Results: Lycium barbarum treatment provides the immediate effect and the persistent effect on     retinal functions and structure in patients with retinitis pigmentosa to improve the cone     activity. It does not cause any harmful effect to the subjects.      Conclusion: Cone rescue is an alternative approach to save the vision for RP patients. The     result of this study will provide valuable information for the treatment of RP. The     antioxidative effect of LB is believed to delay or minimize the cone degeneration in RP and     the intake of LB will be a very economic way in the RP treatment.   "
79571|NCT02244372|"     The investigators performed randomized, double-blind, placebo-controlled human trial to     evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces     hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity     parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP,     antibody titer, and upper respiratory tract infection(URI)   "
79525|NCT02244970|"     Depressive mood and anxiety are prevalent in patients suffering from early psychosis.     Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed     Mindfulness-based intervention (MBI) as an effective option in handling depression and     anxiety. There is a great possibility that MBI is also useful in depression and anxiety     associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong     Kong or any other countries, a brief intervention is more favored. Current paper is a study     protocol for a randomized controlled trial which assess the feasibility of a 7-week     mindfulness-based intervention in patients with early psychosis targeting on their depressive     mood and anxiety.      In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and mild     depressive mood or anxiety will be invited to join this single blind randomized controlled     trial. After baseline assessments, eligible participants will be, using third party simple     randomization, randomly assigned to either the 7-week Mindfulness-based Intervention (MBI),     or the psychoeducation group as control.      The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months.     The secondary outcomes include life functioning, quality of life, other general clinical     symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the     feasibility of the intervention. Data will be analyzed according to the intention-to-treat     principle.      This randomized trial offers an insight into mindfulness-based intervention and its     effectiveness on psychosis concomitants. It provides the foundation for future evaluation and     implementation of an effective and cost-efficient treatment option.   "
79826|NCT02241057|"     This is an open-label study. A total of approximately 60 subjects will be randomly assigned     to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe     or a heat patch (30 subjects) alone. The study will consist of 2 visits.   "
79526|NCT02244957|"     The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea     (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S.     population.The investigators propose to conduct this study that aims: (1) to compare right     and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in     overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive     airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV)     hemodynamics in overlap syndrome.      This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more     RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and     hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia     alone in patients with overlap syndrome.   "
79527|NCT02244944|"     The purpose of this research is to gather information on the combination Zetia® (Ezetimibe)     and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver     function in subjects with nonalcoholic fatty liver disease (NAFLD).   "
79528|NCT02244931|"     The purpose of this study is to compare three assisting devices to propel personal     wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual     wheelchair in patients with spinal cord injury.   "
79529|NCT02244918|"     The researchers are testing if counseling alone or counseling plus over-the-counter nicotine     replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily     smokers quit smoking.   "
79530|NCT02244905|"     Healthcare-associated infections (HAI) are a significant public health burden. Even with     existence of recommendations on technical strategies to prevent these infections, there is a     need for strategies to increase staff engagement within the local organizational and cultural     context. Positive deviance is one such approach that engages people in improvement efforts.     Positive Deviance is based on the observation that in every community there are certain     individuals or groups whose uncommon behaviors and strategies enable them to find better     solutions to problems than their peers, while having access to the same resources and facing     similar or worse challenges. In the proposed study, the investigators plan to test the     effectiveness of using positive deviance based horizontal infection prevention approach to     achieve overall reduction of HAIs among hospital inpatients. The investigators hypothesized     that a broad and horizontal approach to reduce opportunities for acquisition of nosocomial     pathogens using PD will lead to greater reduction of HAI among hospital inpatients compared     to standard-of-care infection control approach. The investigators objective was to test the     investigators hypothesis and evaluate whether there is greater decline in rate of HAI in the     experimental group of wards compared to the control group of wards.   "
79531|NCT02244892|"     Disability glare is described as halos or starbursts around bright sources of light that     can cause discomfort and reduce vision. The cornea is the clear window at the front of the     eye, but certain conditions such as a previous infection can leave a scar. Corneal scars can     cause disability glare by scattering and spreading incoming light instead of allowing it to     focus on the back of the eye (retina) to get a crisp image. In this study, the corneal scar     will be analyzed using a new device that measures scar density (Pentacam), and a relationship     with disability glare will be made. This can help us further understand disability glare and     make better decisions in the future on when to treat these scars to help patients see better.   "
79532|NCT02244879|"     This research will investigate the effect of resveratrol on inflammatory mediators in type 2     diabetic patients in vivo.      The investigators will also investigate the hypothesis that resveratrol has an antioxidant     activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.   "
79533|NCT02244866|"     To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation     (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.      Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH     supplementation) for ovarian stimulation in aged IVF patients.   "
79534|NCT02244853|"     The Cardiovascular disease research using Linked Bespoke studies and Electronic Records     (CALIBER) e-health database was the data resource for this study. CALIBER links patient     records from four different data sources: Clinical Practice Research Database (CPRD), MINAP     (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES),     the Office for National Statistics (ONS).   "
79561|NCT02244502|"     The study is a prospective, single arm, non-randomized, open label pilot trial, designed to     study the safety, toxicity, feasibility and preliminary efficacy of a medical device, the     NovoTTF-100L(O) concomitant with weekly paclitaxel in recurrent ovarian carcinoma patients.     The device is an experimental, portable, battery operated device for chronic administration     of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor,     by means of surface, insulated electrode arrays.   "
79535|NCT02244840|"     Sitz bath is conventional and empirical remedy and commonly recommended for non-operative     treatment of various anal diseases. However, as there was no substitute for sitz bath until     now, the patients have to accept the inconvenience for treatment of their diseases.      Electronic bidet is used with convenience as automatic device for cleansing the perineal     area, especially after defecation. The similarity of contacting water to perineal area,     clinical use of electronic bidet has been suggested for treatment of anal diseases. However,     there had been few reports of clinical use of electronic bidet.      Investigators performed the study to evaluate the effects of electronic bidet on anal resting     pressure, compared to conventional warm sitz bath in normal healthy volunteers.   "
79536|NCT02244827|"     This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate     metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment     and healthy volunteers.   "
79730|NCT02242305|"     In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and     safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of     3 days for the treatment of occasional or recurrent episodes of self-reported gastric or     intestinal spasm-like pain or discomfort   "
79731|NCT02242292|"     Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a     single episode - defined as lasting not longer than 1 day - and multiple episodes of     abdominal pain or discomfort associated with cramping when used as needed   "
79537|NCT02244814|"     The rapidly rising risk of gestational diabetes pregnant women demands that an effective diet     strategy be developed due to the high risk of fetal overgrowth, which places the newborn at     increased risk for childhood obesity and metabolic syndrome. The aims of this randomized     clinical trial are to compare the effects of an 8-wk isocaloric higher complex     carbohydrate/lower fat diet vs. a conventional lower carbohydrate (higher fat) diet on     glycemic and lipid profiles, maternal insulin resistance, placenta nutrient transporters, the     maternal microbiome, neonatal intrahepatic fat, and neonatal total adiposity (primary     outcome). The investigators will then follow the infants for 1-yr and measure maternal breast     milk and infant microbiome composition to observe if they impact net fat mass gain     differently in infants exposed to one diet vs. the other. Identifying a diet for gestational     diabetes mellitus women that can effectively alter maternal/fetal metabolism is critical to     reducing short- and long-term metabolic risk in this growing cohort of mothers and infants     and has the potential to be applicable to overweight/obese pregnant women.   "
79538|NCT02244801|"     This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for     adult, de novo, living donor renal transplant recipients.   "
79539|NCT02244788|"     The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal     Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a     requirement by the FDA for humanitarian use of device   "
79540|NCT02244775|"     The purpose of this study is to allow patients to undergo surgery with the SR™ MCP     (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but     rather, a requirement by the FDA for humanitarian use of device.   "
79541|NCT02244762|"     Determine the influence of renal impairment on the pharmacokinetics and metabolism of     Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules   "
79542|NCT02244749|"     The researcher can proved that certain compounds play an important role in the prevention of     skin cancer. Researcher can use specific compounds, which classified as metabolic enzymes,     and lower concentrations and complete absent in skin cancer cells. Researcher can biopsies of     normal skin and precancerous or cancerous lesions, and can compare the concentrations of     these compounds to determine the difference between the two areas. The result can lead to     further understanding of skin cancers and pre-cancers. Because skin cancers and pre-cancers     are so common, any knowledge would be very useful for many people in the future and may be     used for development of future treatments or prevention strategies.   "
79543|NCT02244736|"     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,     inflammation and elasticity. The association between damage of endothelial glycocalyx,     impaired arterial elastic properties, and CFR in diabetics and first degree relatives has not     been explored. The purpose of this study is to explore the association between damage of     endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and     first-degree relatives before and after during oral glucose tolerance test (OGTT).   "
79544|NCT02244723|"     Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by     mechanically-ventilated patients in the intensive care unit (ICU). It has significant     clinical and economic consequences, as it is associated with considerable morbidity,     increased mortality, and excess health care costs. Appropriate antibiotic therapy for     patients with VAP significantly improves outcomes, making rapid identification of patients     with VAP an important clinical goal.      This application is for support of a prospective, multi-centered study to evaluate the     diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association     of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could     allow for early and reliable diagnosis of bacterial VAP.      Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung     ultrasound alone and in association with the CPIS.      Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural     consolidation, irregular B-lines) in VAP.      Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung     ultrasound, and unprotected tracheal aspirate (UTA).   "
79545|NCT02244710|"     Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel     in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells)     in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1     month).   "
79546|NCT02244697|"     Stridor is a respiratory noise caused by partial obstruction of the large airways at the     level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal     cord paralysis.      Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of     laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient     and the laryngeal view may be obscured due to patient movement or anatomical variations.      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique.     Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability     in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of     laryngeal adduction.      The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the     diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric     population.   "
79622|NCT02243709|"     The goal of this study is to determine if, under stress, alcohol drinking is reduced using     mifepristone   "
79595|NCT02244060|"     Objective measures of health are relatively expensive; meanwhile, self-reports are critiqued     to be subjective and not comparable. A middle ground approach is to apply the frontier work     of vignette methods. The aim of the survey experiment is to explore the validity of survey     instruments to identify students who need glasses, using objectively measured visual acuity     as a gold standard. It is hypothesized that direct comparison against vignette (DCV) is     significantly different from indirect comparison against vignette (ICV); meanwhile,     self-assessment of vision (SAV) is significantly different from primed self-assessment of     vision (PSAV). It is also hypothesized that DCV is a more valid survey instrument than ICV to     classify students who need glasses, using objective visual acuity as a gold standard. Lastly,     it is hypothesized that priming effect from vignettes improves the validity of     self-assessment. It is planned to enroll 3,755 subjects in the survey experiment.   "
79547|NCT02244684|"     An overwhelming body of evidence of the protective effect of folic acid supplementation on     neural tube defect affected pregnancies led to mandatory folic acid fortification in Canada     in 1998. Folate is an important co-factor in the transfer of one-carbon units essential in     DNA synthesis, repair, and methylation reactions, aberrations of which have been implicated     in the pathogenesis of several chronic diseases including cancer. Epigenetic reprogramming     occurs in utero and has the potential to be modulated by the methyl donor supply of which     folate is a contributor. Animal studies have shown maternal folate exposure can modulate     epigenetic changes in the offspring, however, there is limited evidence of this relationship     in humans. The aim of this research is to determine the effects of maternal dietary folate     and supplemental folic acid intake during the periconceptional and in utero periods on global     and gene-specific DNA methylation in human infants. This is a prospective observational study     involving 368 Canadian mother-child pairs recruited from St. Michael's Hospital in Toronto,     Ontario. Dietary and demographical information was collected from consenting pregnant women     at study baseline (12-16 weeks gestation) and in the third trimester (34-37 weeks gestation).     Maternal blood samples were obtained at baseline and prior to delivery and a sample of     umbilical cord blood was collected at parturition to measure levels of folate status. Global     and gene-specific DNA methylation in umbilical cord blood will be correlated with cord and     maternal folate status. The data will be analyzed using separate ordinary least squares (OLS)     regressions. Results from this study will contribute to a better understanding of how     maternal folate and folic acid intake can modulate epigenetic modifications in the offspring     and potentially have an effect on disease susceptibility later in life.   "
79548|NCT02244671|"     immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with     platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat   "
79549|NCT02244658|"     Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe     thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at     evaluating efficacy and safety of rhTPO in management of chemotherapy-induced     thrombocytopenia in acute myelocytic leukemia.   "
79550|NCT02244645|"     This study may clarify a potential promising mechanism and clearest evidence to support the     value of yoga as a therapeutic option for reducing chronic low back pain.   "
79552|NCT02244619|"     The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip     or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV     acetaminophen   "
79553|NCT02244606|"     The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral     SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the     treatment of invasive candidiasis.   "
79554|NCT02244593|"     Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for     detecting breast cancer however, MRI is not always reliable because it can indicate the     presence of cancer when in reality, there is none; this is called a 'false positive' result.     A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with     breast MRI. This study is being done to assess a new technique called FAST breast MRI. A FAST     breast MRI is different than a traditional breast MRI because it has much fewer sequences and     takes approximately 3 minutes for the scan. MRI sequences are combinations of magnetic pulses     that collect information about the tissues. There is no radiation associated with an MRI.      The purpose of this study is to determine the impact on patient health when a FAST breast MRI     is used as a screening technique in women with a personal history of cancer. It has been     shown that FAST breast MRI is similar to routine breast MRI in the detection of breast     cancer, but it has not been proven that FAST breast MRI will help women who have a personal     history for breast cancer. Currently, routine breast MRI is not part of the standard of care     in screening for breast cancer in women who have a prior personal history of breast cancer.     By evaluating FAST MRI the investigators are able to study the effects of this short MRI on     cancer detection in women with a personal history of breast cancer, and on the impact on     overall health. The investigators estimate that 300 participants will be enrolled in the     study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the     Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants     have had a history of breast carcinoma.   "
79555|NCT02244580|"     This is a prospective examination of tumor material of breast cancer patients randomized into     the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as adjuvant     treatments of breast cancer patients wirh a high risk of cancer recurrence).      The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor 1     (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and     Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™.      According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall     survival (OS) will be re-evaluated.   "
79556|NCT02244567|"     High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired     insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women     trying to interfere with the pathophysiology of PCOS in these women as followed up by serum     UC-OC levels.   "
79557|NCT02244554|"     The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal with     picosecond pulse durations as compared to treatment with nanosecond pulse durations using a     single novel Q-Switched (QS) Nd:YAG laser.   "
79558|NCT02244541|"     The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of     ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary     objectives being to explore the relationship between dosing regimen and pharmacodynamics     efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore     the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.   "
79559|NCT02244528|"     The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used     as treatment of pulmonary hypertension in neonate and preterm infant.   "
79560|NCT02244515|"     The purpose of this study is to determine whether dexmedetomidine is effective in the     treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.   "
79562|NCT02244489|"     This study will evaluate the safety, tolerability, and define the maximum tolerated dose     (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with     relapsed/refractory metastatic pancreatic ductal adenocarcinoma.   "
79623|NCT02243696|"     The purpose of this registry study is to confirm the long-term safety and reliability of the     Protego DF4 right ventricular lead.   "
79732|NCT02242279|"     Study to investigate the dose-dependent bronchodilator effect and the safety of single     inhalation doses of BEA 2180 inhaled via Respimat® compared to placebo in patients with     stable Chronic Obstructive Pulmonary Disease (COPD)   "
79563|NCT02244476|"     Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon     consumption, food industry strives to reduce these ingredients while maintaining the taste,     texture and aroma properties of the beverages. A successful reduction of fat and sugar from     drinks has still proven a great challenge since consumers have less preference for the mouth     feel of reformulated beverages than for the regular beverages. Mainly because instrumental     measures like rheology and traditional tribology do not entirely predict the experienced     mouth feel, there is an interest in alternative correlates for mouth feel aspects related to     fat and sugar perception. In a recent study it was demonstrated that vibrations produced     during interaction between the tongue, palate and beverages during consumption are very     sensitive to the amount of fat and texturizers in the beverage. The present study aims at     clarifying that relation for a larger panel of human subjects, by systematically evaluating     vibration spectra during consumption of dairy beverages that differ in fat content, sugar     content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with mouth     feel-related sensory properties and composition of fat deposits on the tongue will be     assessed.   "
79564|NCT02244463|"     This research study is studying a targeted therapy (ML0N128) as a possible treatment for     anaplastic thyroid cancer.      This research study is a Phase II clinical trial. Phase II clinical trials test the safety     and effectiveness of an investigational intervention to learn whether the intervention works     in treating a specific disease. Investigational means that the intervention is being     studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a     treatment for any disease.      MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting     a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic     thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells     which may make the cancer more sensitive to inhibition by MLN0128.      In this research study,the investigators are investigating usefulness of MLN0128 in     metastatic anaplastic thyroid cancer cases.   "
79565|NCT02244450|"     Severe combined Immunodeficiencies ( SCID ) are a group of inherited diseases of the immune     system by characterised profound abnormalities of T cell development . Infants with SCID     require prompt clinical response to Prevent life -threatening infection and studies show     significantly improved survival in babies Diagnosed at birth as a result of previous family     history . SCID follows criteria for population -based newborn screening since it is     asymptomatic at birth and fatal within the first year of life, the confirmation of the     disease is easy, there is a curative treatment , and it is known that early stem cell     transplantation improves survival . Quantification of TRECs (T- cell receptor excision     circles ) in DNA extracted from Guthrie samples is a sensitive screening test for Specific     and SCID .      The investigators propose in this study to perform a neonatal screening of SCID , in a     population of 200,000 babies over a period of two years .      The investigators propose to study the clinical utility and cost effectiveness ratio, and     SCID screening to demonstrate that could result in a broad benefit to Individuals detected ,     making screening relatively cost-effective in spite of the low incidence of the disease .   "
79566|NCT02244437|"     AMS (acute mountain sickness) affects those who ascend too high (>2000m) too fast.     Acetazolamide is an effective drug for the prevention of AMS where proper acclimatization     with gradual ascent may not be an option. AMS presents with headache and other non-specific     symptoms such as nausea, tiredness, and dizziness. Because of the side effects of     acetazolamide such as a tingling sensation, other drugs have been investigated to see if they     will prevent AMS. Ibuprofen has recently been shown to prevent AMS. In this present study the     investigators want to see if acetaminophen can also prevent AMS as acetaminophen unlike     ibuprofen does not have gastric side effects. Second, because acetaminophen has much less     anti-inflammatory component than ibuprofen, it may also provide some insight into the     pathophysiology of AMS if acetaminophen were found to be effective in the prevention of AMS.   "
79567|NCT02244424|"     The purpose of this social media group randomized trial (GRT) is to test the feasibility of     our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues     and implement healthy feeding practices through development of a healthy feeding style.      Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered     to the target population as it relates to their acceptance and satisfaction with the content,     format, delivery, and use of social media.      Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of     infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and     feeding practices evaluated at the completion of the intervention using self-report methods.   "
79568|NCT02244411|"     The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic     leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and     exercise can help people lose weight and improve other health problems. This two year study     will compare two methods of informing participants about ways to lose weight.   "
79569|NCT02244398|"     The purpose of this study is to evaluate the feasibility and acceptability of adding HIV     testing and counseling (HTC) services to the family planning (FP) services provided by     community health workers in Uganda.   "
79570|NCT02244385|"     25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity)     will develop pre-eclampsia and or growth restriction. In addition, the frequency of     stillbirths in this group is dramatically increased over the general population. Pregnancy     complications in this very heterogeneous group are likely to be a combination of a failure of     the maternal vasculature to adapt to pregnancy and/or a failure of placental development. The     relative contribution of these two mechanisms is poorly understood and current preventative     strategies (aspirin) in this group only prevent a small number of adverse outcomes. This     important and complex group have been inadequately investigated to date mainly because of the     diversity of their underlying disease complicating prospective research studies.      The evolution of tools which allow more detailed assessments of both uteroplacental blood     flow and maternal vascular function will enable us to perform prospective studies in these     women and to develop targeted preventative measures. Recent biomarker studies have also     identified a number of biomarkers which have not yet been assessed in these high risk groups.   "
79624|NCT02243683|"     The purpose of this study is to determine the toxicity, tolerability and safety of single     ascending doses of AX-024.HCl in healthy male subjects.   "
79572|NCT02244359|"     One of the toughest decisions faced by the frail elderly in Canada is whether to stay at home     or move to a care facility. It is certainly difficult to make this decision alone, but can be     even harder if someone else makes it for you. Shared decision making is when, instead of     making decisions for the patient, healthcare professionals share information about what the     evidence says, and they talk about what's important with the patient, and then make the     decision together. In the case of the frail elderly in home care services, there are many     health care professionals involved, e.g. the doctor, nurse and social worker. In this case     decisions should be shared by all the professionals involved with the elderly person along     with his or her caregivers. Unfortunately, in this context, shared decision making rarely     occurs.      We have designed a training program that teaches interprofessional teams how to share     decisions with their frail elderly patients, and tested it in one Quebec City and one     Edmonton home care team. This project tests the training program on a broader scale with 16     home care teams attached to community health centres across the province of Quebec, and will     compare the results with what happens when no one has completed the training (usual care).     Home care is a rapidly growing sector and this study will lay the foundations for a national     strategy to ensure that no one has to make this difficult decision alone.   "
79573|NCT02244346|"     Study to evaluate the safety profile of Secotex® in the improvement of the symptoms of Benign     Prostatic Hyperplasia in real clinical practice   "
79574|NCT02244333|"     Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment     after switch from Terazosin-treatment   "
79575|NCT02244320|"     The objective of the observational study were to investigate the switch from phytotherapy to     ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of     ≥ 8 points (International Prostate Symptom Score (IPSS))   "
79576|NCT02244307|"     The primary objective of this observational study was the assessment of prognosis factors for     having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha     blockers. The secondary objectives were the assessment of the time from alpha-adrenergic     blockade treatment initiation to surgery and the evolution of patients during the study.   "
79577|NCT02244294|"     To establish whether the administration of FLOMAX® improves the outcome of a trial without     catheter (TWOC) after an episode of acute urinary retention and to determine whether     spontaneous voiding is maintained over the course of six months of active treatment   "
79578|NCT02244281|"     1. To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily          compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a          significant component of voiding symptoms        2. To study the improvement afforded by FLOMAX® capsules versus placebo, in this patient          population, in quality of life        3. To assess the safety and tolerability of FLOMAX® capsules, 0.4 mg compared to placebo,          in women suffering from LUTS with a significant component of voiding symptoms   "
79579|NCT02244268|"     The aims of this observational study are to identify the primary BPH symptoms responsible for     the patients to consult a urologic practice, resulting in the prescription of ALNA®, to     assess the clincial efficacy on an improved occupational performance of the patients being     still employed. Additionally to obtain relevant information for the 5-year report of     experience with this product according to the requirements in § 49, para 6 of the German     Medicines Act.   "
79580|NCT02244255|"     1. To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg          daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the          signs and symptoms of benign prostatic hyperplasia (BPH)        2. To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in          comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the          symptoms of benign prostatic hyperplasia   "
79581|NCT02244242|"     Study to evaluate the symptomatic relief afforded by tamsulosin hydrochloride capsules in     patients with signs and symptoms of benign prostatic hyperplasia (BPH). Additionally to     provide primary care physicians experience with the use of tamsulosin hydrochloride capsules     0.4 mg daily for the treatment of BPH   "
79582|NCT02244229|"     Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH     patients, two medications indicated in BPH belonging to two different pharmacological     classes, as evaluated from the point of view of patient's perception of his pathological     condition and of the impact of the disease on general health and quality of life   "
79583|NCT02244216|"     Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec®     200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler   "
79584|NCT02244203|"     Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics     and pharmacodynamics of BI 60732   "
79585|NCT02244190|"     To establish the bioequivalence of the new tipranavir oral solution formulation with the     current tipranavir oral solution formulation following single-dose administration. In each     case, 500 mg tipranavir was coadministered with 200 mg ritonavir.   "
79586|NCT02244177|"     Numbers of postoperative PCA related side effects among three groups will be determined by     comparing and analyzing frequency distributions. To determine whether the patients with     hypertension require less post operative opiate analgesics than others, multivariate analysis     with repeated measures will be performed to identify the major and the minor factors     predicting the use of postoperative pain therapy. The major aim of the study is to test the     hypothesis that the morphine comsumpted by the hypertension group is less than those of the     normotension group. The minor aims for the study are the difference related to pain     intensity, or the incidence of side effects among groups.   "
79587|NCT02244164|"     Incretinomimetics and inhibitors of dipeptidyl peptidase-4 (DPP-4) are new treatments for     diabetes. Previous retrospective studies have shown that these treatments induced an increase     in pancreatic mass with potentially a risk for pancreatitis and development of precancerous     lesions.      The aim of our study is to provide a better understanding of the pathophysiological     mechanisms of increased volume and / or pancreatic exocrine secretion when exposed to certain     treatment of type 2 diabetes.   "
79588|NCT02244151|"     The aim of this study is to determine what is the best time interval between GnRH agonist     (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes     (MII) collected in IVF cycles.   "
79589|NCT02244138|"     Preventive care for adolescents is vitally important for maximizing their health and     well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive     needs of adolescents as demonstrated by poor health outcomes for this population.      In this grant application, the investigators propose to expand an existing computer decision     support system (CDSS) into the investigators adolescent primary care practices for the     purpose of implementing a comprehensive, and developmentally appropriate, screening and     physician decision support process. Prior work completed by the investigators research group     has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines.     The investigators seek to positively impact the effectiveness of preventative primary care     visits by applying this previous success to the investigators adolescent practice. The     investigators hypothesize that the implementation of developmentally appropriate universal     screening practices, using tablet technology, and enhanced physician decision support     regarding clinically relevant guidelines for all annual adolescent preventive care visits     will result in better health outcomes, including higher rates of adherence to physician     recommendations and improved patient functioning.      The specific research aims of this proposal are:      Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module     comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years     and tailored evidence-based clinical decision support for physicians.      Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of     specific mental and physical health problems and treatment outcomes in an adolescent primary     health care setting.      Adolescent primary care issues of interest for this project include sexually transmitted     infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The     investigators expect this project to improve the health outcomes of adolescents, guide future     efforts to implement universal screening and CDSS in a variety of primary care settings, and     provide additional evidence to support broad-based electronic screening and computerized     decision support for use in preventive care as a method for improving adolescent health.   "
79590|NCT02244125|"     Imnovid in combination with dexamethasone is indicated in the treatment of adult patients     with relapsed and refractory multiple myeloma who have received at least two prior treatment     regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have     demonstrated disease progression on the last therapy.      Patients with relapsed and refractory multiple myeloma who have received bortezomib,     lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal     treatment, can access to pomalidomide under marketing authorization only as from third line     of treatment.      In France this combination is not authorized for marketing for a first line treatment and     only patient randomized in the IFM/DFCI 2009 trial received it.      This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have     received bortezomib, lenalidomide and Dexamethasone combination in first line, which at     progression/relapse time therapeutic opportunities remained limited and who cannot access     pomalidomide under marketing authorization.      This study is a multicentre, phase 2, open label, study testing the triple combination of     pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who     are refractory or in first progression/relapse after a first line treatment with bortezomib     and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according     to the IFM/DFCI 2009 trial.      In the IFM/DFCI trial, patients in arm A received eight cycles of the     Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance,     patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus     melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of     Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide     maintenance.      This study will contain 3 treatment phases:        -  Study treatment phase:      All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone     combination.        -  Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial):             -  For patients previously randomized in IFM/DFCI 2009's arm A:                  -  Melphalan 200 mg/m2 followed by Autologous Transplantation                  -  Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone                    combination             -  For patients previously randomized in IFM/DFCI 2009's arm B:                  -  5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination        -  Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and          Dexamethasone until progression / relapse or discontinuation for any other reason.      For arm B patients, in case relapse occurs at least 12 months after the end of the     maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation     and therefore follow the arm A procedure. The decision to proceed to a second transplant will     be made by the physician and the patient.      In order to have the same amount of patients enrolled in this trial in the initial Arm A and     Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B,     subsequent patients will be eligible if they have not been initially treated as the first 50     patients from either arm.      The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of     the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the     studied population using International Myeloma Working Group (IMWG) response criteria.   "
79591|NCT02244112|"     The purpose of this Phase 1 of the study is to evaluate the effect of food on the     pharmacokinetics (PK) of oprozomib, the drug-drug interaction of oprozomib with midazolam,     and the safety and tolerability of oprozomib in patients with advanced malignancies   "
79592|NCT02244099|"     The purpose of this study is to characterize and improve controlled substance, carisoprodol     and tramadol use in an internal medicine residents' clinic. Specific objectives of this study     include:        -  To measure the adherence to a controlled substance treatment agreement (CSTA) before and          after implementation of a population management intervention        -  To determine the number of patients on a CSTA with a discrepancy identified on a urine          drug screen or an Ohio Automated Rx Reporting System (OARRS) report        -  To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day          before and after implementation of a review intervention        -  To characterize the healthcare utilization of patients taking controlled substances,          carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions,          telephone calls, and clinic office visits during a 6 month period   "
79593|NCT02244086|"     Abstract.      Epidural analgesia is the most safe and effective for the treatment of pain of childbirth     method. Epidural Bupivacaine provided excellent analgesia for labor and remains the most     widely used local anesthetic in obstetric anesthesia.      Objective: To evaluate the analgesic efficacy of two concentrations of bupivacaine in women     in labor.      Methods: 114 patients were included in labor with term pregnancy. Were grouped randomly into     two groups: patients who received bupivacaine 0.125 % (Group A) and 0.25% bupivacaine (group     B). Patients in group A received 10 ml of 0.125% bupivacaine bolus. The patients in group B     received 10 ml. Bupivacaine 0.25% bolus. Pain intensity according to VAS, blood pressure,     heart rate, respiratory rate, degree of motor block was assessed using the Bromage scale at     different periods of time.      Results: Demographic characteristics and parity were compared, no statistically significant     differences. By comparing the values of the VAS measure 0, 15, 30, 60 and 90 minutes into     statistically significant differences in favor of the group with 0.25% Bupivacaine with     decreased pain perception after 30 minutes, p-value found 0.02. No differences in arterial     pressure, heart rate and respiratory rate were found between the two groups.      Conclusion: The concentration of 0.25% Bupivacaine has greater analgesic efficacy compared     with 0.125% bupivacaine.   "
79594|NCT02244073|"     During the last 2 decades, the management of hyperglycemia in critically ill patients has     become one of the most discussed topics in the intensive-care field. The initial data     suggesting significant benefit from the normalization of blood glucose levels in critically     ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J     Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some     studies suggested that strict blood glucose control might benefit in non-diabetic patient and     worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target     based on glycated hemoglobin measured at ICU admission would improve outcome when compared to     a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a     randomized double blinded study in which Blood glucose control is piloted in both groups by a     web-guided protocol that directly gives instruction to nurses     (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers.     Primary end point is 90 d outcome after randomization.   "
79646|NCT02243397|"     The purpose of the study is to investigate the different types and subtypes of cells found in     breast tumors. The investigators will do this using a variety of molecular analysis tools     that may allow for improved tests. The different types of cells in breast cancer impacts the     way individuals respond to various treatments.   "
80003|NCT02238717|"     This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked     pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.   "
79596|NCT02244047|"     Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of     gluten and related prolamines in genetically susceptible individuals. Not only genetic but     also environmental factors play an important role in CD pathogenesis. CD patients have     imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces     and biopsies.      Up till now, only effective treatment for CD is life long adherence to gluten free diet. If     gluten free diet is not strict that leads over the years to complications of disease, such as     autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous     recirculation of activated immune cells between the inflamed organ and the periphery. To     avoid complications of disease in long term the investigators want to test specific probiotic     bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as     anti-inflammatory.      Hypothesis        1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory          cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy          controls.        2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level          increase.      In the investigators research will be selected 70 children, age from 2 to 18 years, divided     in different groups:        1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive          probiotic for 3 months.        2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive          placebo for 3 months.        3. Group: 20 healthy children   "
79597|NCT02244034|"     Background: Postoperative hypothermia may result in relevant complications such as adverse     cardiovascular events, wound infection, and coagulopathy with consecutive blood loss.     Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for     hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158     patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the     first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface     including wound surface are exposed. Many of these patients receive large amounts of     infusions and transfusions, and undergo hemodilution during CPB, which may additionally     contribute to development of hypothermia.      Objective of the planned study is to find out incidence and duration of postoperative     hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is     the incidence of postoperative complications and its relation to postoperative core     temperature.      Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery     with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative     hyperthermia (> 37.8 °C) and hypothermia (> 36 °C).      The following parameters will be recorded: temperature is measured at ICU after arrived and     after 6 hours which is primary outcome, biometric data include age, sex, body weight, height,     ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical     (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest     temperature during bypass, method of temperature protection, and the outcome of operation .      All data will be described in number and percent and Pearson chi-square method will be used     for analyze correlation between hypothermia and risk factor . P-value <0.05 will be defined     to significant.   "
79598|NCT02244021|"     A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in     relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.   "
79599|NCT02244008|"     The purpose of this study is to verify the effect of anteroposterior talus mobilization on     range of motion, pain, and functional capacity in participants with sub-acute and chronic     ankle injuries.   "
79600|NCT02243995|"     Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent     problems in sarcoidosis. These physical impairments are disabling and affect quality of life     in a negative way. The aetiology of these physical impairments is multifactorial. Physical     inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness.     These symptoms may be partially reversible following a structured physical training program.     However, scientific studies about physical training in sarcoidosis are lacking. Therefore,     the aim of the present study is to examine the changes in fatigue complaints, physical     functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week     physical training program.      After obtaining written informed consent, sarcoidosis patients will start a 13-week physical     training program for three times a week. This training program includes peripheral muscle     training for both the upper and lower extremities (starting at 40% of the multiple-repetition     maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the     speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax).      Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after     ending the training. During these assessments, patients perform muscle strength (m.     quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance     cycling test). They also complete several questionnaires:      Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment     instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical     Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale     (HADS)   "
79647|NCT02243384|"     The purpose of this research is to compare short-term and long-term efficacy of laparoscopic     hepatectomy and radiofrequency ablation in the Treatment of early hepatocellular carcinoma,     and provide the evidence for the choice of surgical method from the pathology and cytology.   "
79648|NCT02243371|"     The primary objective of this study is to compare the overall survival (OS) of subjects with     previously treated metastatic pancreatic cancer treated with cyclophosphamide     (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects     treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).   "
79649|NCT02243358|"     To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy     incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in     combination with chemo-radiation with gemcitabine.   "
79688|NCT02242851|"     Primary objective: to characterize hypertensive patients treated for at least 1 month with     Telmisartan (alone or in combination with other drugs) in order to define the beneficiary     population (those actually receiving the treatment).      Secondary objectives:        -  to describe the patients' blood pressure values (when self-monitored) and satisfaction          with the treatment (ease of use, efficacy, safety) on the basis of a patient          self-questionnaire, filled out 4 weeks after consultation.        -  to compare the characteristics of the beneficiary population to those of the initial          target population defined in the SPC (summary of product characteristics) for          Telmisartan   "
79689|NCT02242838|"     The primary objective of this survey is to prospectively investigate safety and efficacy in     patients with hypertension treated with telmisartan in proper use in medical practice over a     long period   "
79601|NCT02243982|"     The PET tracer Fluoro-ethyl-methyl-amino-naphthyl-ethylidene-malononitrile ([F18]-FDDNP) has     a specific affinity for lesions containing tau protein and beta-amyloid The study consists of     two phases        -  In a first transversal phase, 8 neurologically unimpaired controls, 15 patients with PD          and no dementia (PDND) and 8 with PD and dementia (PDD) will undergo lumbar puncture for          study of tau, phospho-tau and beta-amyloid levels in cerebrospinal fluid (CSF), as well          as positron emission tomography (PET) with ([F18]-FDDNP. Concentration of CSF markers          and both the degree and topography of FDDNP-PET uptake will be compared among groups,          along with correlation analysis between CSF and PET findings.        -  During the second phase (18 months follow-up), the PDND patients will undergo the same          procedures, and cognitive changes including incident dementia will be assessed. The          correlation between cognitive impairment and neurochemical and neuroimaging changes will          be established to determine the predictive value of these markers.      Since the pathological lesions observed in Alzheimer disease (AD) are common in the PD and     the concentrations of tau and beta-amyloid are altered in AD and PET with [F18]-FDDNP is able     to separate patients with AD and cognitive impairment from controls, we hypothesized that:        1. - Patients with PD will show a biomarkers profile similar to the AD (decreased levels of          beta-amyloid and increased phospho-tau and tau) in CSF, and an abnormal uptake of          [F18]-FDDNP PET compared to PDND patients and controls.        2. -The distribution of cortical [F18]-FDDNP in the PD will be different from the AD and          similar to dementia with Lewy bodies, predominantly in posterior cortical areas.        3. PDND patients will show a [F18]-FDDNP PET uptake and levels of protein markers in CSF          intermediate between controls and patients with PD.        4. -In the subsequent follow-up, PDND patients will show cognitive impairment correlate to          changes in the levels of protein markers in CSF and uptake of PET with [F18]-FDDNP        5. - The predictive value for the development of dementia in PD of specific patterns of PET          uptake and CSF proteins profile will be established.   "
79602|NCT02243969|"     Rationale: Increased intakes of n-3 long chain polyunsaturated fatty acids eicosapentanoic     acid (EPA) and docosahexaenoic acid (DHA), mainly found in fatty fish, are recommended for     the prevention of coronary heart disease. Alpha-linolenic acid (ALA, C18:3n-3) is the most     common vegetable-oil based n-3 fatty acid. Evidence exists that ALA supplementation can also     have a protective effect on the development on cardiovascular disease, but may exert its     cardio protective effects through different routes. The benefit may (partly) be due to blood     pressure lowering. However, evidence for beneficial effects of ALA on blood pressure is     conflicting. Therefore, we propose to investigate the effect of flaxseed oil, high in ALA,     using a study powered on 24-hour blood pressure, in a population with high normal blood     pressure and mild hypertension.      Objective: To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial     pressure (MAP) in men and women with high-normal blood pressure and mild hypertension     compared to high oleic sunflower oil, poor in ALA.      Study design: Using a double blind randomized, placebo-controlled parallel design, subjects     will receive at random daily 10 g of flaxseed oil or a high-oleic acid sunflower oil (HOSF)     as control for twelve weeks, with a run-in period of 14 days in advance.      Study population: 72 men and women, aged 40-70 years, with untreated high-normal blood     pressure and stage I hypertension and a body mass index between 25 and 35 kg/m2 will     participate in the run-in and intervention period. It is estimated that 144 subject have to     be screened to find 72 subjects that will enter the run-in period.      Intervention: During the run-in period, subjects will receive daily 10 g of palm super olein     oil. During the intervention period subjects receive either 10 g of HOSF or flaxseed oil. All     oils are provided in bottles of 5 g, one will be consumed at breakfast or lunch and one at     dinner.      Main study parameters/endpoints: The main study parameter is the change in 24h-ambulatory     mean arterial pressure (MAP)   "
79603|NCT02243956|"     The purpose of this study is to investigate effects of a selected food product rich in     polyphenol on cognitive performance and mood.   "
79604|NCT02243943|"     Suboptimal reversal of neuromuscular blockage after surgery is possibly related to     unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete     reversal of neuromuscular block was not possible untill sugammadex was discovered. The     investigators hyposthesise that reversal with sugammadex leads to favorable postoperative     respiratory conditions and less pain compared to reversal with neostigmine.   "
79605|NCT02243930|"     The purpose of this study is to investigate the attachment of a transparent hood (cap) on     the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce     investigation time, and increases the success rate of the sigmoidoscopy. The study focus on     the less-experienced endoscopist.   "
79606|NCT02243917|"     This is a multicenter, open-label, Phase 1 study of orally administered CB-5083 in adult     subjects with advanced metastatic solid tumors. The study will be conducted in 2 parts: an     initial Dose Escalation Phase (Phase 1a) of CB-5083 in subjects with advanced metastatic     solid tumors who have progressed or are non-responsive to available therapies and for which     no standard therapy exists, followed by a Dose Expansion Phase (Phase 1b) which will include     1 to 4 arms: one arm in subjects with RAS mutated mCRC; optionally, at sponsors discretion, 3     additional arms may be added for subjects with advanced RCC, advanced pNET, or solid tumors     with mutations in the RAS-MAPK pathway.   "
79607|NCT02243904|"     Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up     study of lead workers with exposure levels varying between and within individuals. SPHERL     addresses to what extent between-subject differences or within-subject changes in lead     exposure may have a measurable impact on blood pressure, the cardiovascular system, renal     function, the autonomic nervous system, peripheral nervous conduction velocity, and     neurocognitive function.      At the beginning of December 2015, 70 participants were included in the study.   "
79608|NCT02243891|"     The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in     hypertensive subjects is more effective when a ROX coupler is inserted concurrently.   "
79609|NCT02243878|"     This study investigates the use of radiation to treat wet age-related macular degeneration     (AMD). The radiation is delivered using a robotically controlled device that projects     overlapping beams of radiation onto the macula, the part of the eye that is affected by wet     AMD. Participants will be randomized to receive radiation (stereotactic radiotherapy) or     simulated placebo treatment (sham control). They will be followed up regularly for two years,     and then again at the end of three and four years for a safety visit. Participants will also     receive injections of ranibizumab (Lucentis) into their eye if their wet AMD is active.     Ranibizumab is the standard anti-VEGF agent that is used to treat wet AMD. The study aims to     determine if stereotactic radiosurgery can maintain vision and reduce the need for such     regular anti-VEGF injections.   "
79610|NCT02243865|"     The purpose of this pilot study is to evaluate the performance of the Chordate System, in     terms of the prophylactic effect and tolerability of treatment in patients diagnosed with     migraine.   "
79674|NCT02243033|"     Target recruitment: 1000 subjects. The purpose of this research study is to continue to     investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal     therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize     that laser focal therapy can be used to achieve oncologic control in carefully selected     patients.      MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses     light to heat a target area to try to destroy cancerous cells.      The laser system that will be used is called the Visualase® Thermal Therapy System. This     system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers.     However; this study is the first time this system has been studied for use in the treatment     of prostate cancer with a trans-rectal approach.      MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM     trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and     Drug Administration (FDA) for such uses.   "
79611|NCT02243852|"     This study will recruit healthy controls (who have normal GH production and growth hormone     levels) and patients identified as having GHD, who are deemed eligible for GH replacement     therapy according to NICE guidelines. The patients recruited will have been identified as     starting on GH by their referring clinicians and a decision made on their replacement therapy     prior to their potential enrollment in the study. The study, or its research team, will have     no influence on the decision as to whether a patient will start on GH, or on which of the     many GH formulations that the patients receives. The proposed study is an observational study     to determine how GH affects the plasma levels of Fibroblast growth factor 21 (FGF21) in     response to treatment; and whether the change in FGF21 mirrors the improvement in body     composition/fat deposition. FGF21 is a metabolic regulator that acts on multiple tissues to     coordinate carbohydrate and lipid metabolism and regulate energy balance.      We hypothesize that FGF-21 is expressed and secreted from liver and skeletal muscle in humans     in response to growth hormone administration and that levels may be reduced in patients with     GHD compared with healthy controls. Furthermore, we believe that the beneficial effects of     long-term GH replacement on body composition (reduction in visceral adipose tissue,     subcutaneous adipose tissue and liver fat), on improvement in lipid profiles and on skeletal     muscle mitochondrial function involve GH-induced release of FGF21.   "
79612|NCT02243839|"     Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity     The best treatment of PVT is controversial, although surgery and thrombolysis options have     been available. In this randomized and multicenter study, the investigators compared     thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic     valve thrombosis.   "
79613|NCT02243826|"     This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain     induced during lumbar puncture.   "
79614|NCT02243813|"     The current protocol is a pilot study of the effects and possible utility of     psilocybin-facilitated experiences for professional religious leaders.   "
79615|NCT02243800|"     Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and     also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and     synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin     D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and     decreases pro-inflammatory process. There is an inverse relationship, at least in some     epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence     and / or activity of RA. The hypothesis of our study is that natural vitamin D     supplementation in patients with RA and a vitamin D deficiency (vitamin D <30 ng / mL)     improves functional disability.   "
79616|NCT02243787|"     This study is a randomised, double-blind, placebo-controlled, sequential, ascending     single-dose, parallel group study to evaluate safety, tolerability, biological activity, and     systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A)     antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis.     Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v.     infusion, followed by 12 weeks of evaluation.   "
79617|NCT02243774|"     The aim of this study is to determine whether receiving a core letter signed by the Surgeon     General or the Director of the National Vaccine Program that provides only information about     influenza, or a core letter signed by the Surgeon General with an added basic or enhanced     implementation prompt, will increase rates of influenza vaccination among Medicare     beneficiaries when compared to a control group.   "
79618|NCT02243761|"     Families of adolescents struggling with comorbid mental illness and addiction problems     typically experience considerable emotional, financial and social burdens. Concurrent     disorders (CDs) within families contribute to added stress and interpersonal conflict, as     well as disrupt normal routines such as social and occupational activities. Despite the     difficulties associated with being a family member of youth with CD, current mental health     and addictions practices neglect to address this population. The overall purpose of this     project is to assess the feasibility and clinical effectiveness of a Dialectical Behaviour     Therapy skills (DBT) based training group for families of youth with CDs. The following main     hypothesis will be examined: Family members of youth with concurrent disorders who     participate in a 12-week skills group led by therapists and/or peer facilitators will show     reduced caregiver burden and parenting stress from pre to post treatment.   "
79619|NCT02243748|"     This clinical trial studies a palliative care intervention in improving symptom control and     quality of life in patients with stage II-IV non-small cell lung cancer and their family     caregivers. Palliative care programs can provide patients and their caregivers with     information on how to manage their symptoms, maintain health and well-being, and access     supportive care services. An interdisciplinary palliative care model may effectively link     lung cancer patients to the appropriate supportive care services in a timely fashion.   "
79620|NCT02243735|"     The aim of this multicenter trial is to determine the efficacy of preoperative intravenous     iron suppletion in comparison with the standard preoperative oral substitution in anaemic     patients with colorectal cancer in curing the anemia and the assess the effect of     preoperative iron on morbidity, postoperative recovery and quality of life.      Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with     intravenous iron will lead to a higher percentage of patients with normalization of Hb-level     (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men), which potentially     reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be     more cost effective compared to current practice with oral substitution of iron.   "
79621|NCT02243722|"     Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance,     which often happens after the treatment for laryngopharyngeal and esophageal cancer and may     induce fatal complications such as aspiration pneumonia. By the conventional examinations,     the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It     is utmost important to establish a comprehensive quantitative method which is sensitive     enough to evaluate the neuromuscular functions. The present project will evaluate the     laryngeal nerve function by quantitative laryngeal electromyography, which was developed by     the research team, and another novel examination technique, mucosal membrane sensation test.     The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively     before the significant symptoms or complications and can also help to evaluate the treatment     effect from medicine, rehabilitation or surgery.   "
79625|NCT02243670|"     This study uses an artificial intelligence platform to automatically confirm medication     ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform     can be downloaded as an 'app' onto any smartphone to automate directly observed therapy     (Automated DOT®). Real-time patient adherence data are encrypted and automatically sent to a     centralized web-based dashboard for use by healthcare professionals or research staff. Unlike     Facetime® or Skype®, the system relies on computer vision algorithms to confirm the process     of medication administration; no human review is necessary.      The purpose of this study is to evaluate the feasibility and acceptability, and measure the     accuracy, of the AiCure platform (platform) in patients being treated for opioid dependence     with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1) to assess     the feasibility and acceptability to both participants and study staff in using AiCure to     monitor medication adherence; 2) to evaluate the acceptability of using AiCure to optimize     care pathways; and 3) to measure the reliability and validity of AiCure in detecting     interruptions in treatment. To assess feasibility and acceptability of the platform, we will     measure rates of physician satisfaction and user acceptance. Optimization of care pathways     will be measured by assessing the sustainability of AiCure use over 12 weeks (retention     rates) and measuring illicit opioid use (urine drug screens) compared to historical data.     Reliability and validity of AiCure will be measured by comparing AiCure adherence against     pharmacokinetic data.      All participants will be requested to take each of their prescribed doses using the app.     Participants will be able to download the app onto their own smartphone or will be     provisioned a device at the start of the study. The data captured during the medication     ingestion process will be automatically encrypted and stored on the participant smartphone     and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed     dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be     sent to study staff via email or SMS to prompt immediate intervention. In addition, all     participants will receive treatment as usual.   "
79626|NCT02243657|"     The study investigates how safe ASP3652 is and how well it is tolerated when taken as     multiple doses. The study also assesses how quickly and to what extent it is absorbed and     eliminated from the body. In addition, the effects of age and gender are investigated.      The study consists of two parts. In Part 1 four dose levels are administered to four separate     groups initially. Two additional dosages are then investigated. Subjects receive either a     once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.      Part 2 is performed in one group of elderly healthy male or female (post-menopausal)     subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.      For both parts of the study, the subjects stay in the clinic for one period of 18 days.   "
79627|NCT02243644|"     Comparing the effect of two different duration of same drug albendazole in patients with     Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.   "
79628|NCT02243631|"     This study will investigate the hypothesis that probenecid, a medication currently used for     gout, reduces levels of ATP in the joint fluid of patients with calcium pyrophosphate     deposition disease (CPPD), another common type of crystal-related arthritis. There is good     evidence that CPPD results from an excess of ATP in joints. The investigators will measure     levels of ATP in joint fluid before and after 5 days of treatment with probenecid. This study     will serve to rationalize larger studies of probenecid in CPPD.   "
79629|NCT02243618|"     Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc     resection of superficial tumors in the gastrointestinal tract. ESD, however, is a     time-consuming procedure that requires a high level of endoscopic skill to achieve a     desirable oncologic outcome. Several procedure-related complications may occur after ESD.     Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and     patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are     administered after ESD. In addition, ulcer protective agents such as rebamipide can be added     to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for     healing of iatrogenic ulcer.   "
79630|NCT02243605|"     This phase II trial studies how well cabozantinib-s-malate works in treating patients with     osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of     improvement. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and may also prevent the growth of new blood vessels that     tumors need to grow.   "
79631|NCT02243592|"     This pilot research trial studies molecular profiling in tissue samples from patients with     cancer who got better with treatment that didn?t work for most other patients with the same     disease. Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify     biomarkers related to how well patients respond to treatment.   "
79632|NCT02243579|"     This phase II trial studies how well pembrolizumab works in treating patients with stage     IB-IVB mycosis fungoides or Sezary syndrome that has returned after a period of improvement     or has not responded to at least one type of treatment. Monoclonal antibodies, such as     pembrolizumab, may block cancer growth in different ways by targeting certain cells.   "
79633|NCT02243566|"     The purpose of the study was to examine the effect of six- to eight-week treatment with     MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure     control. In addition, the post-marketing surveillance study offered the possibility to obtain     information about the influence on different laboratory parameters during treatment with     MicardisPlus® from an unselected patient group under office conditions   "
79634|NCT02243553|"     Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir     500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp)     biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine,     warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.   "
79635|NCT02243540|"     The aim of this study was to evaluate an impact of preoperative bladder underactivity on     treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser     enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to     compare it between the two types of surgery for benign prostatic hyperplasia.   "
79636|NCT02243527|"     The effects of inspiratory muscle training (IMT) remain controversial. Many studies have     examined the effect IMT has on exercise performance, but any changes to the body that come     from IMT have yet to be looked at.      This study will look at how someone breathes can change after IMT. Understanding how IMT     changes the body can help us use IMT in different treatments.   "
79637|NCT02243514|"     Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these     conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an     important part in the autonomic nervous system regulation, especially in cardiovascular     system, the modulation of the renal nerves used as a therapeutic strategy has been researched     across the world. The purpose of this study is to evaluate and quantify the morphology     changes in different diseases, make the modulation therapy more selective and effective.   "
79638|NCT02243501|"     Up to 25% of children suffer from sleep problems categorized as insomnia: difficulty     settling, falling asleep, and staying asleep. This leads to daytime sleepiness and negatively     effects behaviour, mood, and academic performance. It also has negative effects on primary     caregiver's sleep and their daytime functioning. Despite robust evidence supporting the     efficacy of behavioural treatments for insomnia in children, very few receive these     treatments. The most common treatment for insomnia in children is medication. This pattern of     care is troubling because there are no approved medications for insomnia in children, and     there are concerns about the safety and side effects of these medications. One of the primary     reasons for the low rate of evidence-based treatment is the shortage of available treatment     resources for both parents and health care providers.      When evidence-based treatments are available, they are usually provided in a traditional     service delivery framework. These traditional approaches are often very difficult for parents     to access due to scheduling conflicts, incidental costs, and travel difficulties. Thus, there     is a critical need for access to effective interventions focused on insomnia for children,     and increased knowledge for parents and health care providers about appropriate treatments     for insomnia.      The Better Nights, Better Days (BNBD) program will provide a potential solution to one of the     most common treatment barriers: access to care. BNBD will provide a readily accessible     distance treatment via the internet, to increase access to evidence-based care for insomnia     in typically developing children aged 1 to 10. BNBD was developed based on evidence-based     programs and extant literature. The investigators will conduct a randomized controlled trial     (RCT) in which participants (primary caregivers of children ages 1 to 10 years with insomnia)     will be assigned to Intervention or Usual Care based on a 1-to-1 allocation. The effects of     this behavioural sleep intervention will be assessed at 4 and 8 months post baseline     assessment. Assessment will include both sleep and daytime functioning of the children, and     daytime functioning of their caregivers.      This study aligns with the recognized need to more rapidly transfer new scientific knowledge     to improve patient care and population health, and targets the validation of new treatment     delivery models to increase availability of effective treatment.   "
79639|NCT02243488|"     This study builds on the pilot work of the Irise research group to investigate the impact of     menstrual hygiene interventions on East African girls' school attendance, activities of daily     living and self-esteem. The trial will be carried out in 40 schools to either intervention or     control arms. Schools will receive a menstrual hygiene program, including the distribution of     reusable sanitary pads and menstrual health education. The impact of the programme on girls'     school attendance will be monitored using the validated Irise questionnaire and school     registers. The impact of the programme on activities of daily living during menstruation and     self-esteem during menstruation will also be measured using the Irise Questionnaire and     explored using focus groups.   "
79640|NCT02243475|"     Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact     on patients' quality of life and health care costs. Not all individuals with neuropathy     develop pain and it is not possible to predict who is more or less susceptible among those     with similar risk exposure. Current inability to identify high-risk individuals hinders     development and application of therapies to counteract neuropathic pain and to address     targeted prevention strategies. Recently, the investigators Consortium has identified novel     pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to     play a critical role in the generation and conduction of action potentials in nociceptors and     their terminal axons. This study was undertaken in a carefully selected group of patients     with painful neuropathy using a candidate gene approach and directly revealed targets for new     therapeutic strategies. This discover widened the spectrum of sodium channel-related pain     disorders including conditions more common in the general population than those known so far.     PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a     cohort of patients with predominantly small fibre neuropathy, aims to develop this original     idea in a larger and well characterized study population, to provide evidence for the     reliable stratification of patients at high risk and potential new treatments tailored on     patients' clinical features, in order to improve their quality of life.   "
79641|NCT02243462|"     Shivering is one of the most commonly recognized problem associated with anesthesia, It is     believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior     to the surgery can reduce the chances of hypothermia induced shivering during the post     operative period.      Forced air warmers are the most frequently used active warming devices in the peri-operative     setting. Currently, our hospital does not pre-warm patients but if our study shows that     pre-warming reduces post-operative shivering, we will be able to make an evidence based     decision to start this practice.   "
79642|NCT02243449|"     During weaning the work of breathing is transferred from the ventilator back to the patient.     Approximately 40% of the time on ventilators is spent weaning. Studies support the use of     screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to     identify weaning candidates. The investigators work demonstrates that once daily screening is     the current standard of care. The conduct of daily ward rounds and once daily screening in     ICUs is poorly aligned with the rapidly changing clinical status of critically ill patients.     With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant     opportunity exists to screen patients more often, conduct more SBTs, and reduce the time     spent on ventilators and in the ICU. Only one mechanical ventilation trial has focused on the     elderly and no trial has evaluated weaning outcomes in the elderly and very elderly which may     be influenced by the presence of comorbidities, frailty, malnutrition and treatment     limitations.      The investigators propose to conduct a pilot randomized trial in 100 elderly (>/= 65 years)     critically ill adults comparing 'once daily' screening to 'at least twice daily' screening in     8 adult ICUs. In the proposed trial, the investigators will (i) evaluate their ability to     recruit elderly (>/= 65 years) critically ill patients into a weaning trial and (ii) assess     whether protocols can be adhered to similarly between elderly (65 to 80 years) and very     elderly (>80 years) trial participants. Moreover, they will also address generalizability     issues in the conduct of mechanical ventilation research by evaluating potential biases     associated with exclusion criteria and consent between elderly and very elderly patients and     obtain preliminary estimates of differences in important clinical outcomes between elderly     and very elderly participants.   "
79643|NCT02243436|"     Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with     ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment     with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation.   "
79644|NCT02243423|"     This study aims to compare the neonatal acid-base status of women who remain supine     horizontal, with women who are tilted to the left side by 15° during elective cesarean     delivery at term under spinal anesthesia, with systolic BP maintained at baseline with a     phenylephrine (PE) infusion. The null hypothesis is that the position of the patient (supine     horizontal or tilted) during cesarean section will make no difference to neonatal wellbeing.     The primary outcome will be the neonatal umbilical arterial base deficit (BD) at birth. The     investigators will also examine the effects of maternal position during cesarean section     under spinal anesthesia on maternal cardiac output (CO) and whether these changes have a     correlation with the neonatal umbilical cord blood acid-base status. The secondary outcome     will be the total phenylephrine dose requirement at 15 minutes after spinal injection.   "
79645|NCT02243410|"     It has come to our attention that there is not a general consensus of how to apply Visual     Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.      The assumption is that patients will grade the level of pain differently dependent on how VAS     is presented.   "
84464|NCT02180451|"     The purpose of this study is to characterize the circadian rhythm disruption experienced by     patients as determined by plasma melatonin, cortisol, and other circadian analytes   "
79650|NCT02243345|"     Decompression sickness syndrome (DCS) is caused by microbubbles forming in blood vessels or     tissues during a reduction in environmental pressure (decompression). Bubbles have     mechanical, embolic and biochemical effects with manifestations ranging from none to fatal.     By reducing bubble volume and hastening inert gas elimination, recompression therapy with     hyperbaric treatment remains the main therapy for DCS. The most common hyperbaric protocol     used, is based on US Navy Treatment table 6, started as early as possible after surfacing.     The outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the     patients suffering from severe DCS, and in 73%-100% of the patients with mild-moderate DCS.      The significance of time to recompression is controversial. It has been suggested that early     hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further     tissue injury. However, in recent studies time to recompression had very little effect on     clinical recovery. Moreover, the time beyond which hyperbaric treatment isn't effective has     not been determined yet.      The aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment to     divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after     surfacing. The clinical outcome of the delayed hyperbaric treatments was compared to early     treatments given at the same hyperbaric unit.   "
79651|NCT02243332|"     The purpose of this small, pilot study is to evaluate a novel device that uses neuromuscular     electrical stimulation to assist quadriceps muscles as a user walks. This study will involve     use of this device on individuals with patellofemoral pain, a relatively common injury among     active people, to see if quadriceps stimulation could mitigate disparities in quadriceps     activation timing that may indirectly lead to knee pain.   "
79652|NCT02243319|"     The purpose of this study is to investigate the pharmacokinetic drug interactions between     HGP1201 and HGP0904   "
79653|NCT02243306|"     GSK1278863 is an orally-active, novel small molecule agent which inhibits hypoxia-inducible     factor (HIF) prolyl -4- hydroxylases (PHDs) and is in development for the treatment of     anaemia associated with chronic kidney disease (CKD). As the kidney represents a major site     of elimination for many drugs and their metabolites, and GSK1278863 will be administered to     subjects with various stages of renal disease, it is important to characterize the     pharmacokinetics in this target patient population. The purpose of this study is to     characterize the pharmacokinetics of GSK1278863 and its metabolites in subjects with end     stage renal disease (ESRD) undergoing peritoneal dialysis. This will be a repeat-dose,     open-label, parallel-group study. Approximately 30 subjects with ESRD will be enrolled in two     cohorts (15 subjects in each cohort) to ensure that 6 subjects on continuous ambulatory     peritoneal dialysis (CAPD) (cohort 1) and 6 subjects on automated peritoneal dialysis APD     (cohort 2) complete dosing and critical assessments. GSK1278863 will be administered once     daily for 14 days. Primary pharmacokinetic assessments will be made on Days 1 and 14.   "
79654|NCT02243293|"     The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or     ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV     genotypes 2, 3, 4, 5 or 6 infection.      In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment     with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without cirrhosis     compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in GT2-infected     DAA-naive subjects without cirrhosis.   "
79655|NCT02243280|"     The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the     efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and     without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1     (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated     cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially     planned in the protocol, it was not administered in any of the study arms.   "
79656|NCT02243267|"     The investigators are creating a data and specimen repository to study causes , early     detection, prevention and treatment of colon and rectal cancer. The investigators are     collecting data and specimens (blood, stool, urine and tissue) from people who have colon or     rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies.     Data and samples are held in the repository until there are enough to be used for a large     study or until there are new techniques that can be used to test them. The GI SPORE Program     at the University of Michigan maintains a repository of specimens for colorectal diseases     that the investigators hope will help fuel new research. The investigators hope that this     work may lead to new treatments or earlier detection of colorectal cancer or improved     diagnosis and treatment of other colon and rectal diseases.   "
79657|NCT02243254|"     Postoperative hyperalgesia has been reported after intraoperative administration of small or     high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the     development of opioid-induced hyperalgesia. The aim of this study is to evaluate the     preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia   "
79658|NCT02243241|"     Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg     tablets) on the QT/QTc interval.   "
79659|NCT02243228|"     The purpose of the study is to evaluate if inhaled granulocyte-macrophage colony stimulating     factor delay the increase in alveolar-arterial oxygen difference, compared to no treatment,     for adult patients with mild-to-moderate autoimmune pulmonary alveolar proteinosis in China     over a two-year period.   "
79675|NCT02243020|"     The primary study objectives are to assess the safety and feasibility of the therapy,     including the surgical intervention and stimulation, as well as to provide information on the     appropriateness of the study test measures (assessments) and to provide a basis for sample     size calculations for a larger, pivotal study.   "
79676|NCT02243007|"     This research study is a Phase II clinical trial, which evaluates a combination of drugs,     FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable     pancreatic cancer prior to surgery.   "
79677|NCT02242994|"     The purpose of this study is to evaluate a touch screen application designed to help     pediatric patients with cerebral palsy communicate. The study will test how well patients     type on two different tools: one tool is already on the market , and the second tool is a     newly developed App.   "
84806|NCT02175953|"     This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a     specifically on the needs of caregivers of people with dementia composed new short-term     psychotherapeutical intervention.   "
79660|NCT02243215|"     The study is a randomized study exploring the difference between off-site vs. on-site     training in laparoscopic skills. The study will be performed using fifty surgical trainees     from the departments of urology, surgery and gynecology. The participants will be recruited,     enrolled and randomized during the introductory course in basic laparoscopic techniques held     six times annually at Center of Clinical Education(CEKU).      Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual     Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency     on seven basic modules, the procedure module; salpingectomy on the LapSim™ and reach the     passing level of 358pts on the Training and Assessment of Basic Laparoscopic     Techniques(TABLT) technical test.      The intervention group will have a portable trainer available to allow training at their     convenience, be it at home or at work. The control group will only practice on-site at CEKU     and at their local hospital.      Participants will be asked to keep a training log with details of time spend on training and     number of training sessions. The training log will contain information on any type practice     involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet     trainer or training at CEKU. Also time spend in the operation room, assisting or performing     laparoscopic surgery will be registered.      To pass the TABLT all participants will book a test session at CEKU for their final test at     the end of their training. At the test sessions TABLT test scores will be established on site     by the Chief Investigator and afterwards using video recordings of the test. A blinded rater     will give scores based on the video recordings and this will be the decisive rating to     determine whether the participant has passed the test.      To pass the VRS training an employee at CEKU will monitor a VRS practice session in which     proficiency level is reached.      The enrollment of participants is expected to finish June 2015 a data analysis will be     performed in July 2015.   "
79661|NCT02243202|"     The purpose of this study is to compare the effects of canagliflozin and phentermine to those     of placebo to promote on a change in body weight over a 26 week period.   "
79662|NCT02243189|"     The purpose of this study is to investigate the cytokine levels in nasal lavage and gene     expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy     participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which     there is wheezing and difficulty in breathing) participants with and without nasal allergen     challenge prior to dosing.   "
79663|NCT02243176|"     SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active     Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin     Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes     Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy   "
79664|NCT02243163|"     The purpose of study is to investigate if yoga exercise improve life quality and immune     status in breast cancer patients after complete treatment (including surgery and / or     radiotherapy and / or chemotherapy)   "
79665|NCT02243150|"     This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in     humans and will allow further development of G1T28 1 in patients with cancer to reduce     chemotherapy-induced myelosuppression.   "
79666|NCT02243137|"     This is a phase I clinical trial in healthy volunteers comparing the effect of lysine     acetylsalicylate or aspirin on platelet function.   "
79667|NCT02243124|"     The purpose of the study is to test the safety of six cycles of cenersen treatment and to     begin to test the hypothesis that intermittent administration of cenersen may lead to a     reduced dependence on transfusion.   "
79668|NCT02243111|"     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler     ultrasound system incorporating a special signal processing package; i.e. the transthoracic     parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may     provide important insight into pulmonary blood vessels characteristics by the LDS signals     that are related to pulmonary hypertension.      The TPD performance in detecting PAH in SSc patients will be assessed in the study.   "
79669|NCT02243098|"     The trial is conducted in Europe. The aim of the trial is to investigate the influence of     semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single     doses of atorvastatin and digoxin in healthy subjects.   "
79670|NCT02243085|"     The aim of this study was to investigate the incidence of de novo urge urinary incontinence     after the photoselective vaporization of the prostate for benign prostatic hyperplasia using     the validated overactive bladder symptom score, and to determine the predictors of de novo     urge urinary incontinence following the photoselective vaporization of the prostate.   "
79671|NCT02243072|"     Adolescents with T1D and chronic poor metabolic control are at high risk for short and     long-term diabetes complications and are heavy users of both medical resources and health     care dollars. The purpose of the proposed study is to collaborate with a community agency to     develop and test an intervention, Fit Families, that uses the core components of a previously     successful home-based family treatment, but that can delivered by lower cost community health     workers. If successful, Fit Families could improve health outcomes in a vulnerable population     at high risk for diabetes complications, and could be translated to real-world treatment     settings.   "
79672|NCT02243059|"     Advanced epithelial ovarian cancer has high morbidity and mortality. Patients presenting with     advanced stage ovarian cancer often have cancer spread to regional lymph nodes. Imaging     strategies to depict involved lymph nodes are currently not successful. The purpose of this     study is to evaluate if magnetic resonance imaging (MRI) with gadofosveset trisodium contrast     enhancement (GDF-MRI) and diffusion weighted imaging (DW-MRI) is able to identify involved     lymph nodes in a preoperative setting. This could guide the surgeon during surgery to dissect     lymph nodes which could lead to an optimal diagnosis/staging with the lowest possible     morbidity. We want to determine the optimal imaging settings and feasibility of MRI for the     detection of pathological lymph nodes in women with advanced (FIGO stage IIB-IV) ovarian     cancer undergoing primary debulking surgery and compare this to conventional imaging with     computer tomography (CT).   "
79673|NCT02243046|"     This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one     hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.   "
79678|NCT02242981|"     This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has     been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally     occurring radioactive form of the element, carbon. This study will increase understanding     about how the drug appears in the blood, urine, and stool after it is administered to healthy     participants. Information about any side effects that may occur will also be collected. This     study will last up to 22 days for each participant, not including screening. Screening is     required within 28 days prior to enrollment   "
80287|NCT02235012|"     Characterise cognitive biases resulting from low dose ketamine infusion, used as a     pharmacological model of psychosis.      Our assumption is that low dose ketamine results in reasoning biases by impairing the way     uncertainty is monitored and taken into account for decision making.   "
79679|NCT02242968|"     Background:      - Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group     of healthy volunteers for clinical trials. Clinical trials are studies that test these     vaccines and therapies in people.      Objective:      - To screen volunteers for clinical trials for investigational or licensed vaccines or drugs     to treat or prevent virus infections.      Eligibility:      - Healthy adults age 18 65.      Design:        -  Participants will be asked questions about their health history, including sexual          activity and drug use. They will give blood samples. They may have a physical exam. They          may give a urine sample.        -  Participants may have the inside of their nose either swabbed or washed with some fluid.          The fluid will be collected. They may give a stool sample.        -  Participants may have an electrocardiogram. Soft, sticky patches will be attached to          participants chest, arms, and legs. They will lie still on a table while the patches          detect the heart s electrical signals. A machine will record these signals.        -  Participants may have lung function tests. These tests measure the volume of air moving          in and out of the lungs. Participants will forcibly blow air into a machine.        -  Participants will be told if any tests show a medical problem.        -  If a participant is eligible and decides to join an investigational clinical trial,          researchers will explain the study and the risks involved. Participants will sign a          separate consent for that clinical trial.   "
79680|NCT02242955|"     Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol     withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference     medication for preventing or treating AWS. The recommended average diazepam treatment     duration is usually around one week, and this duration is generally not considered to impact     the subsequent relapse rate in alcohol drinking.      However, several previous studies have found that patients experienced frequent anxious     symptoms during the weeks following detoxification. Such symptoms may foster early relapse in     alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late     withdrawal symptoms.      The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one     month can significantly reduce the cumulated relapse rate in alcohol drinking over the three     following months.   "
79681|NCT02242942|"     This open-label, multicenter, randomized Phase III study is designed to compare the efficacy     and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +     chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical     conditions. The anticipated time on study treatment will be approximately one year and the     follow-up period will be up to 5 years.   "
79682|NCT02242929|"     Basal cell carcinoma (BCC) is a slow-growing, locally invasive malignant epidermal skin     tumour. It is the most common malignant disease in Caucasians, representing approximately 80%     of all cases of skin cancer and is therefore an important health problem. In the Netherlands     incidence rates are 165 for men and 157 for women per 100.000 person-years, and these rates     are rising with 3-10% every year.      A simplified histological classification of BCCs includes the following three subtypes:     nodular, superficial and infiltrative variants, with the nodular variant being the most     frequent type. Although a characteristic feature of BCCs is their low risk to metastasize, if     untreated they may be locally invasive and may induce considerable functional and cosmetic     morbidity.      The gold standard treatment of all histological BCC subtypes is surgical excision (SE), but     not all patients are eligible for surgery. In patients with multiple BCCs and older patients,     surgery may lead to significant morbidity, and in some cases, it may result in disfiguring     scarring. For these reasons and to reduce workload and costs in the healthcare system, there     is a growing demand for alternative, non-invasive, treatments. An advantage of non-invasive     treatment options is that they can be performed by other healthcare professionals, such as     general practitioners and specialized nurses. For treatment of superficial BCCs (sBCC)     non-invasive treatments, such as topical imiquimod (IMQ), 5-fluorouracil (5-FU) or     photodynamic therapy (PDT) are already commonly used. Our group investigated the efficacy of     those three therapies and found that after 3 years, BCCs treated with IMQ had a significant     lower risk of recurrence, compared to the other therapies.      A recent study suggests that IMQ, besides being an immune-response modifier, also directly     inhibits sonic hedgehog (SHH) signalling, the most important pathway active in BCCs. This     targeted effect of IMQ very likely explains the superior therapeutic effect. Treatment of     nodular BCC (nBCC) with IMQ has been investigated. Without prior curettage, high efficacy     rates were found, although efficacy was still slightly inferior to SE.      The investigators hypothesize that the effectiveness of IMQ following prior curettage will     not be inferior to SE and that the benefits will be a higher patient satisfaction and lower     healthcare costs. A recently published discreet choice experiment showed that patients     preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment.   "
79683|NCT02242916|"     Given that the cost of proton therapy is considerably higher than that of conventional     radiotherapy with photons, it is necessary to establish whether these higher costs are     worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations     in which proton therapy outperforms conventional photon treatment is needed. The     investigators therefore aim to demonstrate through an in silico trial that proton therapy     decrease the amount of irradiated normal tissue and, consequently, the risk of side effects     in the surrounding normal tissue as well as the risk of secondary tumors. The same overall     treatment time and an equal number of fractions will be used for both treatment modalities     wherever possible. The most optimal technique for each individual patient, based on objective     criteria related to limiting dose to normal tissue, will be prescribed by the institution     concerned for each treatment option.   "
79684|NCT02242903|"     The main purpose of this study is to evaluate the safety and how well the body will handle a     single dose of study drug, LY3079514. This study will last about 12 weeks for each     participant.   "
79685|NCT02242890|"     This study has two goals: 1) to test an approach to helping women who use intrauterine     contraception (IUC) spread the word about this type of long-lasting, highly effective birth     control method among their friends and family and; 2) to test ways of getting in touch with     these women's friends and family so that investigators can track whether this approach is     effective at spreading birth control information through social groups.   "
79686|NCT02242877|"     The aim of this study is to compare the effect of treatment with telmisartan on patients in     whom the systolic BP is approximately 12 weeks after starting treatment under control for the     first time between patients with isolated systolic hypertension (ISH) at the beginning to     patients with systolic/diastolic hypertension (SDH)   "
79687|NCT02242864|"     The primary objective was to evaluate the effect of the treatment with Micardis® or     MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® /     MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin     Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension     and diabetes mellitus   "
79726|NCT02242357|"     Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual     daily-practice prescribing conditions in hypertensive patients   "
79693|NCT02242786|"     Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic     applications. Especially, it is expected the DW MRI could provide valuable information about     early response evaluation after treatment using rapid apparent diffusion coefficient (ADC)     value change. It has demonstrated potential usefulness in response evaluation in the liver     tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy     (RT). Furthermore, it is a functional imaging technique that does not require a contrast     agent, it can be safely used in patients with renal insufficiency or other medical     contraindications for contrast agents.      The optimal assessment of early response of RT could provide one of the most important     information to prescribe patient and cancer specific RT dose. It might be also important in     palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.      This study is performed to evaluate the usefulness of DW MRI in early response evaluation     after RT for HCC bone metastasis.   "
79694|NCT02242773|"     1. Multiparametric MRI ultrasound (MRIus)-guided or direct MRI-guided biopsies will allow          for more directed sampling of the tumors from compartments with distinct          multiparametric-MRI (MP-MRI) characteristics, termed habitats, that will increase the          rate of progression on early (first and second) surveillance biopsies and decrease the          rate of progression on late (third and further) surveillance biopsies compared to          historic transrectal ultrasound (TRUS)-guided biopsy rates.        2. Identifying higher risk tumor early on will reduce the proportions of patients with poor          response to delayed primary treatment.        3. Radiomics signatures from MP-MRI will define patterns that are associated with          progression.        4. Genomic signatures based on RNA from tumor tissue will define patterns that are          associated with habitats and radiomics signatures, as well as progression.   "
79695|NCT02242760|"     This is a randomized, multi-center, double-blinded study in subjects with moderate to severe     acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2     concentrations of a topical drug in development or a vehicle. Subjects will be treated for up     to 12 weeks.   "
79696|NCT02242747|"     Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic     keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy.      Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial     AKs.      Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients     with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three     consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated     at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.   "
79697|NCT02242734|"     Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of     Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules   "
79698|NCT02242721|"     Approximately 300 patients have to be enrolled in the study. They are followed up until the     end of ICU stay. Usually in clinical routine, patients suspected to have infection and     simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate     specimens are drawn and sent for analysis on specific time points. The analysis results are     sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to     optimize antiinfectiva treatment of the study patients.      Data are used to test calculation tools and modify them if necessary.   "
79699|NCT02242708|"     The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative     nostril breathing to improve life quality, autonomic nervous system and immune status.   "
79700|NCT02242695|"     A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg     dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients     suffering from vulvovaginal candidiasis, to assess safety of the two medications during the     treatment, and to evaluate women's satisfaction with the two treatments.   "
79701|NCT02242682|"     The purpose of this study is to determine if video education is an effective means of     caregiver education in the waiting room of a pediatric emergency department (ED). This will     be tested with the showing of a child passenger safety video.   "
80288|NCT02234999|"     To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects   "
79702|NCT02242669|"     The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target     individuals with psychiatric diagnoses such as mood disorders, and provide evidence either     supporting the expansion of such groups and the development and testing of clinical     procedures, or point toward reevaluation and development of alternative low-cost, community     based approaches to promoting recovery among individuals suffering from these disorders.   "
79703|NCT02242656|"     MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people     with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the     symptoms of Short Bowel Syndrome and reduce the number of times subjects experience bowel     movements.   "
79704|NCT02242643|"     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'     quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®     Quadrivalent in children 6 to 35 months of age.   "
79705|NCT02242630|"     It is currently unknown whether or not the improvement in pain and function related to a     steroid shot for shoulder pain due to subacromial bursitis is important. This study seeks     to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone     significantly affect improvement in shoulder pain 6 weeks after injection.   "
79733|NCT02242266|"     The primary objective of this trial was to establish non-inferiority of lung function     response to tiotropium 10 μg, formulated as inhalation powder in the polyethylene hard     capsule and delivered via the HandiHaler® 2, compared to tiotropium 18 μg, formulated as     inhalation powder in the hard gelatine capsule and delivered via the HandiHaler® (Spiriva®)     following single dose inhalation in patients with COPD. A hard polyethylene (PE) capsule with     half the strength (tiotropium 5 μg) was included to investigate a dose ordering effect.      The secondary objectives were to characterize the pharmacokinetics of tiotropium inhalation     powder hard PE capsule (delivered via HandiHaler® 2) and tiotropium inhalation powder hard     gelatine capsule (delivered via HandiHaler®) and to compare the safety of the two     pharmaceutical formulations.   "
79706|NCT02242617|"     Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians.     It is the cause of significant healthcare costs with increased morbidity and mortality. The     two most common and effective therapies used to treat OSA are: (1) Continuous or Automatic     Positive Airway Pressure (PAP), and (2) Mandibular Advancement Splints (MAS). While both     therapies reduce upper airway collapse during sleep, they differ in efficacy, acceptance,     cost and side-effects, but surprisingly are similar in improving quality of life, sleepiness     and blood pressure. PAP is more effective in reducing apneas while MAS is easier to use.     Until now, studies have used self-reported adherence data on MAS versus objective adherence     on PAP. Many studies have hypothesized that the sub-optimal efficacy with MAS therapy is     counterbalanced by the superior adherence relative to PAP, resulting in a similar     effectiveness for both treatments. Compliance smart chips are a recent innovation for MAS and     could be used to prove this hypothesis and allow a new and complete comparison of     effectiveness (efficacy + adherence) between MAS and PAP. Understanding the patient's     objective adherence and long-term symptomatic improvement would provide vital information to     doctors and dentists in choosing the right treatment for patients. Sixty OSA patients will     receive both PAP and MAS in a random sequence. This innovative study lead by two experienced     new investigators, and a research team of multidisciplinary experts, will assess objective     adherence, treatment efficacy, patient preference, sleepiness and quality of life of each     treatment used at home for 1 month per treatment. After this, patients will be able to go     back and forth between both treatments during an additional 6-month period. The results of     this study will be used by healthcare policy makers as well as clinicians who need to be part     of the treatment plan decision for the many Canadians who suffer from sleep apnea.   "
79707|NCT02242604|"     Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical     capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a     battery of validated assays after correction of hyponatremia in patients 70 years or older.   "
79708|NCT02242591|"     The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo     on muscle strength, mobility and pain on the first postoperative day after total knee     alloplastic (TKA).   "
79709|NCT02242578|"     Symptomatic treatment of the negative symptoms in schizophrenia (such as social withdrawal,     affective flattening, poor motivation, and apathy) with medications and psychotherapy are     almost non-existent, whereas treatment of the positive symptoms (hallucinations and     delusions) has been more effective with psychotropic medications. The proposed research on     human subjects using a non-invasive technology (such as repetitive transcranial magnetic     stimulation [rTMS]) will provide efficacy data for treating negative symptoms.      The hypotheses are that 1) Cerebellar stimulation will cause activation of thalamic and     frontal cortical networks associated with attentional processes as a component of the     distracted affect of schizophrenia; 2) Cerebellar stimulation will cause activation of the     reticular activating system (RAS), and this will allow the mutism, which is a negative     symptom, to be partially improved.   "
79710|NCT02242565|"     The purpose of this study is to assess the safety of ShangRing MMC procedures when providers     choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult     sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.   "
79711|NCT02242552|"     A new research paradigm that involves sequencing tumor DNA/RNA to identify driver mutations,     select among the Health Canada approved drugs (for adult cancers) known to block certain     oncogenic pathways, and recommend these drugs to the treating physician, without taking into     account the tumor histology.      In this paradigm, the treatment is targeted to the actionable mutation(s) i.e. those driving     oncogenesis. It is also personalized to the molecular signature of the patient's tumor,     irrespective of its histopathological subtype. The experience of the investigators team in     genomics, including next generation sequencing and bioinformatic analysis combined with the     clinical expertise, bring at last this approach within our technical capacities. In parallel,     the number of Health Canada-approved drugs (which have been tested in a pediatric setting)     designed to interfere with oncogenesis pathways is increasing exponentially.   "
79712|NCT02242539|"     In this study, we aim to improve child nutrition by increasing parents' awareness of their     children's physical growth. We use a cluster-randomized trial design to evaluate two     interventions that provide parents with regular information on their children's physical     development and growth: 1) distribution of full-sized growth charts for measurement of child     height within households; and 2) organization of community-based meetings, during which     children's height and weight are measured by trained project staff.   "
79713|NCT02242526|"     The investigators propose a randomized, single blinded controlled trial to compare the use of     synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of     care surgical modalities. The investigators hypothesize that use of synthetic mesh will have     lower recurrence at these time points compared to use of biologic mesh.   "
79714|NCT02242513|"     Although there are many conservative method for plantar fasciitis, patients might spend 2     years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF)     lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no     studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using     ultrasound-guided (UG) techniques.   "
79861|NCT02240602|"     Postoperative pain control is required after major abdominal surgery, including laparoscopic     colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control     mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous     oxycodone for pain control after laparoscopic colorectal surgery in Korean.   "
79715|NCT02242500|"     The purpose of this study is to compare the clinical outcomes after coronally advanced flap     technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of     single gingival recessions. For this blinded randomized controlled clinical trial, 40     patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will     selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters     evaluated will be probing depth, clinical attachment level, gingival recession height, height     and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45     days, 2, 3 and 6 months after surgery.   "
79716|NCT02242487|"     This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of     CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor     fluctuations (OFF episodes). All patients will receive active treatment, but patients will be     blinded to dose level. This will serve as an extension to the CVT-301-004 study for those     patients who participated in that study and remain eligible for this study. In addition,     patients who previously completed the CVT-301-003, CVT-301-009 and CVT-301-005 (observational     arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the     CVT-301-004E eligibility criteria.   "
79717|NCT02242474|"     Rheumatoid arthritis (RA) is a frequent inflammatory arthritis that can lead to severe joint     deformity and often requires orthopaedic surgical interventions. Anti-Tumor Necrosis Factor α     (anti-TNFα) are biological disease-modifying antirheumatic drugs (DMARDs) increasingly used     in the treatment of rheumatoid arthritis. An increased risk of opportunistic infection was     demonstrated in patients treated with those drugs. This observation led many national     committees to recommend anti-TNFα suspension in the perioperative period to avoid a raise in     the postoperative infection risk in those patients. This approach is not supported by the     data available in the current literature and it exposes patients to an increased risk of     inflammatory flare ups of their disease during and after anti-TNFα suspension, which can     compromise their postoperative rehabilitation and their quality of life.      The objective of this prospective randomized multicentric trial is to determine the effect of     anti-TNFα suspension in the perioperative period on the postoperative infection risk.     Overall, 660 rheumatoid arthritis patients requiring an elective foot or ankle surgery will     be randomized into two groups. In the first group, anti-TNFα will be stopped 3 half-lives     before the surgery while they will be continued in the second group. The postoperative     infection rate will be compared between the two groups. Postoperative complication rates,     flares and revision surgeries as well as the functional improvement will be compared.      The study hypothesis is that there is no significant difference in the risk of postoperative     infection between the two groups.      Results from this study will help determine the optimal way to use anti-TNFα in the     perioperative period and will therefore improve the quality of life of rheumatoid arthritis     patients.   "
79718|NCT02242461|"     We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with     moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation     and anti-oxidation for these patients, and these effects (2) may reflect in the improvement     of patients' physiological measurements, quality of life and exercise tolerance.   "
79719|NCT02242448|"     Background:      - Computed tomography (CT) scanning is a procedure that helps doctors with diagnoses. It uses     X-ray radiation to produce an image in three dimensions. Researchers want to study how to get     the best quality CT scans using the lowest possible radiation dose.      Objective:      - To determine how to improve CT scanning.      Eligibility:      - Adults 45 years of age and older who have not had a CT scan in the past year and do not     have kidney disease.      Design:        -  Participants will be screened with a medical history and blood and urine tests.        -  Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for          several hours during the magnetic resonance imaging (MRI) and CT scans. Through this IV,          blood will be taken, dye will be injected, and medicine will be given.        -  Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis.          Participants will lie on their back on a table. The table will slide into a donut-shaped          machine. An X-ray tube will move around the body, taking pictures.        -  Participants may be given a drug called a beta blocker by mouth or through the IV tube.        -  Participants heart rate and blood pressure will be monitored.        -  Participants may have an MRI scan. The MRI is a large hollow tube. The participant will          lie on a table that will be moved into the tube, which contains a magnetic field. When          the imaging starts, a thumping sound will be heard. Headphones or earplugs will be          provided to muffle the sound.        -  Participants will give blood samples.   "
79720|NCT02242435|"     In this Phase III clinical trial, approximately 320 eligible patients with OA of the knee     will receive Ampion™ 4 mL or Saline 4 mL (1:1) administered as three IA injections, 2 weeks     apart at Day 0, Week 2, and Week 4.   "
79721|NCT02242422|"     The aim of this study was to identify the serial changes in lower urinary tract symptoms     (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for     treatment of female stress urinary incontinence.   "
79722|NCT02242409|"     A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting   "
79723|NCT02242396|"     The primary objective was to evaluate, through the use of Home blood pressure monitoring     (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in     patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis     Plus®, Telmisartan hydrochlorothiazide.      The co-primary endpoints were the degree of BP control, and change from baseline until study     end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in     the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis     Plus®, Telmisartan hydrochlorothiazide.      Secondary endpoints were office BP control rates, office BP response rates, and reduction in     mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit,     discontinuations and tolerability   "
79724|NCT02242383|"     To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice     prescribing conditions with a special emphasis on controlling morning blood pressure   "
79725|NCT02242370|"     Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to     establish the effect on patient's quality of life scores.   "
79727|NCT02242344|"     Study to assess the blood pressure lowering effects of two doses of telmisartan over a     four-week treatment period; to determine potentially effective doses for pediatric patients     for future studies; to assess the safety and tolerability of two doses of telmisartan.      Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of     telmisartan in children and adolescents aged 6 to <18 years, and to determine if age-related     differences exist   "
79728|NCT02242331|"     This post-marketing surveillance study is designed to supplement under conditions of normal     clinical practice data on safety, tolerability and efficacy of Micardis® collected in     clinical studies with special emphasis on the control of blood pressure in the morning before     intake of the next antihypertensive drug   "
79729|NCT02242318|"     The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering     diastolic blood pressure in patients who missed a dose of their medication, as measured by     ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to     valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end     of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)   "
79734|NCT02242253|"     Main Study: To evaluate and to compare the lung function response to the free combinations of     tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18     μg QD at the end of 6-week treatment periods in patients with COPD.      Sub-Study: Was performed in subset of patients participating in the Main Study to assess the     effect of the four randomised treatments on dynamic hyperinflation.      Extension Study: To establish whether the FEV1 time profile following combination     bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical     formulation of salmeterol, i.e. the MDI or the Diskus®.   "
79735|NCT02242240|"     Study to establish the lung function effects of added formoterol (12μg QD and BID) during     2-week periods to pharmacodynamic steady state of tiotropium(18μg QD)   "
79736|NCT02242227|"     The primary objective of this trial was to establish non-inferiority of lung function     response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder     delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent®     Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose     inhalation in patients with COPD.      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation     powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate delivered     by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.   "
79737|NCT02242214|"     The design of the study is post-marketing, observational, multi-centre and open-label. The     study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery     system (VDS) is prescribed may be included. All directions for medication usage and patient     monitoring are solely at the discretion of the investigator in accordance with their usual     practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg     VDS. No other (invasive) study-related interventions or measurements are done, other than the     procedures routinely performed during induction of labour. No effort is expected from the     study subjects. 150 patients from 20 Dutch centres will be included.   "
79738|NCT02242201|"     Total hip arthroplasty is a one of the most commonly performed surgical procedures with     increasing numbers anticipated over the next several decades. Differences in the analgesia     outcomes between these three intervention groups would provide for an evidenced-based     clinical pathway that will emerge as a result of this study.      Hypothesis:      Patients undergoing total hip arthroplasty within a clinical pathway utilizing preemptive     low-dose opioid and non-opioid medications for multimodal analgesia randomized to peripheral     nerve blockade will report less pain with movement on an NRS scale POD #1 compared to     randomization to periarticular injection with ropivacaine mixture or periarticular injection     with liposomal bupivacaine (Exparel&#174;).   "
79739|NCT02242188|"     INTRODUCTION Exclusively breastfed infants are at risk of iron deficiency. American Academy     of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants     beginning at 4 months of age. Uncertainty exists regarding the effects of iron     supplementation during infancy on neurodevelopmental outcomes in the absence of anemia.      AIM To establish whether psychomotor and mental development is influenced by early iron     supplementation in healthy, non-anemic, exclusively or predominantly breastfed infants.      METHODS Healthy term newborns will be recruited shortly after birth. If predominantly     breastfed (>50% daily feedings) and non-anemic at 4 months, they will be randomized to     receive either an iron supplement (approx.1mg/kg/day) or placebo until 9 months of age.     Participants will be assessed with use of Bayley Scales of Infant and Toddler Development     (Bayley III) at 12, 24 and 36 months of age.   "
79862|NCT02240589|"     The purpose of this study is to determine if memantine can improve cognitive and     neuropsychiatric outcomes after severe traumatic brain injury.   "
79740|NCT02242175|"     Irritable bowel syndrome is characterized by abdominal discomfort and bowel habit change. It     is increasing worldwide. But the pathophysiology of the irritable bowel syndrome is not     proven. So, the treatment's target is the relief of the symptoms.      Small intestinal bacterial overgrowth considered as the cause of the irritable bowel     syndrome. Because, it is related to the postprandial abdominal discomfort and the abdominal     discomfort could be relieved after taking antibiotics. There are several diagnostic methods     for small intestinal bacterial overgrowth. hydrogen breath test is non-invasive method for     diagnosis of the small intestinal bacterial overgrowth. But, there is no standardized cut-off     value for the hydrogen breath test. So, we want to compare the hydrogen breath test between     the irritable bowel syndrome patients and normal people. And then, we want to analyze the     efficacy of hydrogen breath test for the diagnosis of irritable bowel syndrome.   "
79741|NCT02242162|"     Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional     measures of inspiratory muscles strength include the nasal pressure with an occluded nostril     and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of     patient effort. The mean of this reseach is to validate a non-invasive and non-volitional     technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist     to compar PImax measure to nerves magnetical stimulation maneuvers measure.   "
79742|NCT02242149|"     This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults     treatment with diacerein will improve glycemic control and will reduce liver fat within a 24     month period.   "
79743|NCT02242136|"     Soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former     conflict regions were and are often exposed to multiple traumatic events and situations in     which they are forced to engage in violent behavior. The treatment program Formation,     Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a     short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress     Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior.     Addressing trauma-related mental disorders as well as emotions related to aggression by means     of FORNET is expected to facilitate reintegration in civil life and reduce uncontrolled     violence.      The investigators want to provide evidence, that FORNET is an effective and efficient module     to assist soldiers after deployment in Somalia and/or male and female ex-combatants who     fought in the civil war in Burundi. In addition the investigators aim to explore how     traumatic incidences and maltreatment during childhood may influence treatment outcomes.   "
79744|NCT02242123|"     Celiac disease (CD) is a chronic immune-mediated disorder that occurs in genetically     predisposed populations. Patients affected by the disease may be asymptomatic or manifest     classic malabsorption symptoms of diarrhea, steatorrhea, abdominal pain, and weight loss     after gluten ingestion (and related derivatives found in other grains). Diagnosis and     screening begin with the use of serologic tests, i.e. IgA anti-tissue transglutaminase (tTG)     and IgA anti-endomysial antibodies (EmA). Duodenal biopsy, still considered by many as the     criterion necessary for diagnosis, demonstrates the pathologic findings of small intestinal     villous atrophy, crypt hyperplasia, and intraepithelial lymphocytosis that occur on exposure     to dietary gluten. Genetic tests, revealing permissive haplotypes, may be helpful in     identifying susceptible individuals. CD diagnosis is still anchored to the criteria     established by the European Society of Pediatric Gastroenterology Hepatology and Nutrition in     1990. These require the mandatory presence of (a) villous atrophy with crypt hyperplasia and     increased intraepithelial lymphocytes (IELs) count when the patient is eating gluten, and (b)     a full clinical remission after elimination of gluten from the diet. As a consequence,     patients with minimal or no intestinal histology lesions pose a considerable problem, as     serum anti-tTG and EmA are known to be often negative, or weakly positive, in patients with     CD with mild intestinal damage. The investigators, in 2002, measured anti-tTG antibody in the     culture medium of intestinal biopsy specimens from patients with suspected CD and evaluated     the relationship between antibody production and severity of intestinal mucosal damage, and     demonstrated that anti-tTG assay of the culture medium of biopsy specimens can improve the     accuracy of CD diagnosis in patients negative for serum antibodies. The same investigators,     in 2011, evaluated the diagnostic accuracy of EmA assay in the culture medium of intestinal     biopsies for CD diagnosis and demonstrated that EmA assay in the culture medium had a higher     sensitivity and specificity than serum EmA and anti-tTG assay. The present study is performed     to investigate the clinical usefulness of the in vitro production of EmA in CD diagnosis in a     large number of consecutive adult patients with suspected CD and weakly positive [e.g. 2-3xN]     serum anti-tTG.   "
79745|NCT02242110|"     Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological     intervention developed to target trauma-related nightmares and sleep disturbances. Though     further evidence is needed, ERRT has shown strong support in reducing the number and     intensity of nightmares, as well as improving overall sleep quality in both civilian and     veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar     disorder.   "
79746|NCT02242097|"     This study is being done to see whether or not a drug called ibrutinib can be given to     patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy.     This drug blocks an enzyme that affects how the lymphocytes grow and survive. The     investigators hope to learn how safe and effective ibrutinib is for treating patients with     MCL after responding to induction chemotherapy.   "
79747|NCT02242084|"     Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic     events in the central nervous system (CNS). In most cases the consequences are catastrophic,     with a high rate of severe functional disability and mortality rate up to 30%.      Ischemic stroke of the spinal cord can arise from:        1. Dissection of the aorta.        2. Aneurism in the aorta.        3. Atherosclerotic disease of the aorta or vertebral arteries.        4. Spinal surgeries.        5. Spinal AVM.        6. Embolism from cardiac origin.        7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in          hours until the patient becomes paralyzed in two or in all four limbs. In most cases the          damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor          weakness accompanied by disturbance of temperature and superficial sensation, urinary          retention or bowel disorder, with preserved position and vibration sense.      The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis     of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS).     Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the     spinal cord is necessary upon arrival in the emergency department.      One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and     validated in numerous studies for ischemic events in the brain, until today no validated     study in ischemic spinal stroke using thrombolysis has been completed.   "
79748|NCT02242071|"     The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic     Lateral Sclerosis patients.   "
83072|NCT02198651|"     A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging     TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of     Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA).   "
79749|NCT02242058|"     There has been little progress for effective treatment of pain in sickle cell disease (SCD)     patients. Many organizations have recognized that understanding the causes and reducing the     burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As     patients with SCD face the challenge of living with both acute and chronic pain which is     often improperly treated, our translational and interdisciplinary project aims to identify     objective measures of pain sensitivity and its biochemical and genetic correlates. We     hypothesize that SCD patients will have decreased tolerance to thermal and electrical     stimuli.   "
79750|NCT02242045|"     This study will evaluate the 28-day safety, tolerability, and pharmacokinetics (PK) of     idelalisib with or without ofatumumab in Japanese participants with relapsed or refractory     indolent non-Hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL).   "
79751|NCT02242032|"     The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic     Solution in subjects with mild to moderate dry eye disease.   "
79752|NCT02242019|"     The purpose of this study is to determine whether low level laser light therapy is effective     in the treatment of toenail onychomycosis.   "
79753|NCT02242006|"     Severe acute kidney injury (AKI) is a common complication of critical illness affecting     almost half of all patients with septic shock. Extracorporeal renal replacement therapy is a     cornerstone in the management of AKI in these patients. Options for renal replacement therapy     include continuous renal replacement (CRRT) therapy, intermittent dialysis (IHD) or a hybrid     form of the two called sustained low efficiency dialysis (SLED). Globally there is a push to     switch from traditional CRRT to SLED. Although there are resource and financial comparative     benefits to SLED there is almost no literature describing how to dose antimicrobials (or     other drugs for that matter). It appears that drug clearance on SLED may be more efficient     than CRRT but not as efficient as IHD making extrapolation from these bodies of literature     inappropriate for SLED. The investigators are proposing to conduct the population     pharmacokinetic studies for the three most commonly used antimicrobials in critically ill     patients receiving SLED therapy (piperacillin-tazobactam, meropenem and vancomycin).     Population pharmacokinetic modeling of these drugs will provide estimates and sources of     variability around pharmacokinetic parameters that will subsequently be used for Monte Carlo     simulation to determine the most appropriate dosing regimens to achieve therapeutic targets     while minimizing the risk of toxicity.   "
79756|NCT02241967|"     The proper control of acute and chronic pain is one of the most important areas in health     care. Despite the profound advances in neuroscience over the past 20 years, the investigators     still largely use opiate narcotics, much as was done in the Civil War. Total knee     arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee     pain is often a complaint that precedes TKA, the procedure itself is associated with     considerable post-operative pain lasting days to weeks. Adequate postoperative pain control     is an important factor in determining recovery time and hospital length of stay. New     analgesic strategies are needed that can be used adjunctively to existing strategies with the     potential to reduce reliance on opioid analgesia. Several novel brain stimulation     technologies including transcranial magnetic stimulation (TMS) and transcranial direct     current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety     of pain conditions. Electricity has no metabolite or other residue, and can be delivered with     minimal discomfort and without problems associated with drug-drug interactions. In two     independent preliminary pilot studies, the Investigators have shown that tDCS can reduce     post-operative PCA use by as much as 46% while simultaneously reducing subjective pain     ratings. The present study aims to determine the effects of transcranial direct current     stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and     post-surgical complications during the 48-hour post-operative period following total knee     arthroplasty.   "
79757|NCT02241954|"     The hypothesis of the study is that individuals with poor pulmonary function secondary to TIS     will benefit from expansion thoracoplasty. The investigators specific aims are to:        1. Record pulmonary function and thoracic volume of TIS patients at enrollment and with          serial observation        2. Offer expansion thoracoplasty therapy to TIS patients with             1. poor pulmonary function at enrollment             2. progressive decline in pulmonary function             3. progressive chest wall and/or spinal deformity             4. lack of appropriate increase in thoracic volume during growth        3. Document efficacy of expansion thoracoplasty for TIS patients   "
79758|NCT02241941|"     The purpose of this study is to determine single dose pharmacokinetics of daptomycin     consecutively in 10 patients on three different time points after severe burn injury.   "
79759|NCT02241928|"     The purpose of this study was to analyze the effect of autologous bone marrow mononuclear     cells in muscular dystrophy.   "
79760|NCT02241915|"     Surgical site infections (SSI) are costly complications that may cause significant morbidity     and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS)     are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of     benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we     hypothesized that a microbial sealant could reduce the rate of SSI by half for clean     contaminated colorectal procedures (Class 2).   "
79761|NCT02241902|"     The aim of this study was to identify serial changes in the incidence of postoperative pyuria     after the Photoselective Vaporization of the Prostate (PVP), to determine whether the     presence of postoperative pyuria could be correlated with surgical outcomes after surgery and     to identify predicting factors that influence on persistent pyuria after the PVP.   "
79858|NCT02240641|"     The study aimed at comparing the evolution of renal function in patients showing a     hypertension treated by various therapeutic strategies.      Due to the contract research organisation (CRO) decision in September 2000, the database was     locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to     stop the study and not proceed to the analysis. Thus, only safety data were processed in the     safety database.   "
79762|NCT02241889|"     Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar     are paving the way to revolutionize the management of this disease. The benefit of improved     control of blood sugar levels compared to standard insulin pump therapy has already been     demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably     during exercise. The investigators research group has shown that small doses of glucagon can     prevent low blood sugar when used in a blood sugar control system in patients with type 1     diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the     ability to recognize the onset of physical activity in order to appropriately adjust the     insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia.      The purpose of this study is to test how well a new modified blood sugar control system     controls blood sugar during exercise compared to: 1) the current system without modifications     and 2) standard insulin pump therapy.   "
79763|NCT02241876|"     Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as     the oral cavity, pharynx and larynx. The most effective treatment consists of high dose of     cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities     caused mainly by oxidative stress. The objective of this study will be evaluate the use of     n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and     neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial     with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital /     University of Campinas (UNICAMP). Head and neck cancer patients who will begin cisplatin     antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will     be included in this research. They will be studied in 2 groups (n-acetylcysteine and     placebo). All patients will be evaluated in relation to cisplatin induced hematologic and     gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and     cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be     statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated     measures tests (p<0.05.)   "
79764|NCT02241863|"     Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar     disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to     treatments is also a major obstacle in translating efficacy in research settings into     effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication     treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD     are multi-dimensional, and it has been suggested that a multifaceted intervention will be     more effective. The study is aimed to assess the effectiveness of a multifaceted intervention     on enhancing medications adherence in patients with bipolar disorders.   "
79766|NCT02241837|"     The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant     and Delivery System in the partitioning of the left ventricle in patients with heart failure     due to ischemic heart disease. This sub-study has the additional assessment of improvement in     Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement     after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure     and volume as functional parameters of the Left Ventricle.   "
79767|NCT02241824|"     Rationale        -  Statement of the Problem. Low back pain is a significant societal problem in the United          States, affecting approximately one-fourth of all Americans at any given time.          Non-pharmacological therapies have not been well studied although preliminary evidence          shows the utilization of bracing may be beneficial in reducing pain and medication          usage.        -  Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic          lumbar brace may decrease opioid use in chronic low back pain patients on a stable          opioid regimen. The investigators propose to conduct a randomized controlled study to          test our hypothesis.        -  Specific Objectives.      AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable     opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace,     elastic abdominal binder (standard care), and no brace (control).      AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life,     and functional capacity.      Long Term aims: To decrease patient's chronic pain level, improve overall daily function,     decrease overall opioid intake and improve quality of life.   "
79768|NCT02241811|"     Chronic foot wounds which is very difficult to treat are common especially in diabetic and     peripheral arterial or venous insufficiency patients. This research is aim to observe the     foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.   "
79769|NCT02241798|"     The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon     dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU).     The investigators hypothesize that providing oxygen prior to seizures will help eliminate the     drops in changes seen during seizures, such as the drop in oxygen saturation and increase in     carbon dioxide levels.      Research will be done on patients that are admitted to the EMU specifically to have seizures     occur and to be recorded on video electroencephalography (vEEG), and the only research     intervention will be the use of oxygen prior to some of the seizures.      The importance of this research relates to the phenomenon of sudden unexplained death in     epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found     dead by their families in the morning, without a clear cause for death. The risk of SUDEP is     as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple     mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation     during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to     decrease significantly in 25-50% of patients during or shortly after a seizure while being     monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger     a cascade of events from which the body may not be able to recover, leading to SUDEP. In     animal models, providing oxygen prior to seizures occurring has been shown to eliminate     oxygen desaturation, but more importantly eliminate mortality in animals prone to death due     to seizures.      Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it     reduces the risk of oxygen desaturation during the apneic period of the procedure. On room     air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes     following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to     oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs     from which transfer to the bloodstream can continue despite the lack of ventilation. The     apneic episode during seizures should benefit from the same principle.      The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better     characterize seizures, to identify the main seizure focus. In addition to standard EEG with     electrodes on the scalp, some patients require invasive localization of the epileptic focus     by surgically placing electrodes within the skull (often referred to as GRID patients) on or     within the brain, with the goal of being able to resect the area that is causing seizures. To     identify where seizure originate electrically, it requires that seizures occur during the     vEEG procedure. To provoke seizures, medications are typically lowered, and both partial     seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will     occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex     partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use     oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators     also have the capability for both for clinical usage.      Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs     following seizures as part of the post-ictal nursing care, though there is no outcome data to     support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of     oxygen desaturations clinically, as seen in animal models, and this is the goal of this     research project.   "
79770|NCT02241785|"     The primary objective of the study is to determine the efficacy of natalizumab (Tysabri,     BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed     Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the     proportion of participants with no evidence of disease activity (NEDA) at Year 1. The     secondary objectives in this study population are: change in total T1 hypointense and total     T2 hyperintense lesion volume; proportion of participants with NEDA at Year 2; evaluation of     the impact of natalizumab on annualized relapse rate (ARR); and change in Multiple Sclerosis     Impact Scale-29 (MSIS-29) physical impact score.   "
79771|NCT02241772|"     A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a)     levels.   "
79772|NCT02241759|"     A study in healthy males and females to see if a high single dose of TA-8995 has an effect on     the ECG QTcF interval.   "
79773|NCT02241746|"     The purpose of this study is:        -  to diagnose malnutrition in Chinese hospitalized patients with four nutritional          screening tools: mini-nutritional assessment - short form, subjective global assessment,          malnutrition universal screening tool and nutritional risk screening 2002.        -  to optimize the usage of nutritional screening tools based on data-mining methods.   "
79859|NCT02240628|"     The main objective is to evaluate if combining placing the Synera patch and using Propofol     /Lidocaine mixture will further decrease the pain associated with the IV injection of     Propofol.   "
84807|NCT02175940|"     This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in     eyes with mCNV treated with IVB.   "
79774|NCT02241733|"     People with moderate to severe COPD trap air in their lungs. This lessens their ability to     exercise. The investigators developed a computerized breathing retraining program to help     patients empty their lungs during exercise. The investigators believe that learning to     control breathing will help patients be more active. The purpose of this study is to test the     effects of using breathing retraining (intervention group) versus no breathing retraining     (control group) as part of a 12-week exercise program. The investigators are examining the     long term effects of this training on exercise capacity and the ability to empty ones lungs     during exercise. Patients will participate in a 12-week exercise program, with or without     breathing retraining. They will then participate in a 42 week adherence program to maintain     physical activity. Patient testing will be competed at baseline, 12 weeks, 6 months and 1     year. 250 patients with moderate to severe COPD will be enrolled.   "
79775|NCT02241720|"     Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced     Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach   "
79776|NCT02241707|"     In this proposal, the investigators seek to determine whether a reduced compression after     endovenous ablation procedure in treating superficial venous insufficiency affects the     outcomes. This study involves only the use of the compression stocking post endovenous     ablation procedure and everything else is standard according to current guidelines.      The investigators general strategy will be to determine the role of a minimal post-operative     compression and the status of patient satisfaction including (1) Success closure rate of the     treated vein. (2) Less pain; (3) Easier accepted by the patients.   "
79777|NCT02241694|"     This survey is conducted in South America. The purpose is to identify the key psychosocial     issues affecting patients with haemophilia.   "
79778|NCT02241681|"     Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to     decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their     metabolites have not been explored in details.      This is an exploratory study aiming at determining the plasma level of MCT and their     metabolites after oral intake of Peptamen.   "
79779|NCT02241668|"     The goal of this clinical research study is to learn if using a new imaging solution,     3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help     doctors determine if your brain lesion is from the tumor returning or the effects of previous     treatments.      The results of this imaging scan (called an FLT PET scan) will be compared to the results of     a Magnetic Resonance Imaging scan, which you have already had or are scheduled to have     outside of this study.   "
79780|NCT02241655|"     This study aims to determine whether, compared with usual anesthetic care, an     electroencephalography-guided anesthesia protocol is effective at preventing postoperative     delirium and its downstream effects, and improving postoperative patient reported     health-related quality of life.   "
79781|NCT02241642|"     The purpose of this Clinical Investigation is to validate that the clinical use of the     VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm     its performance to percutaneously close femoral arterial puncture sites in the range of 18-24     F, post endovascular procedures.      This is a non-inferiority study based on safety. Safety will be assessed by incidence and     severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3     months from implantation is no worse than those associated with cut-down and sutured close.   "
79782|NCT02241629|"     A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical     superiority study.   "
79783|NCT02241616|"     Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B     Virus (HBV) is one of most etiologies of Liver cirrhosis in China. The effective inhibition     of HBV can partially regress or reverse liver fibrosis in patients with chronic Hepatitis and     liver cirrhosis due to HBV, however some patients keep existence or development although HBV     DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required the     anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix,     especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis.     Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and     have a good action against liver fibrosis in patients with chronic hepatitis B. However,     there are no high quality clinical evidences which can demonstrate if the combination of     anti-viral and anti-fibrotic therapy can improve the reversion of refractory liver fibrosis     in liver cirrhosis due to HBV.      The primary objective of this study is to establish the safety and efficacy of the     combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in     liver cirrhosis due to HBV.   "
79784|NCT02241603|"     Obesity is a common problem in the Veteran population as at least 1 in 3 Veterans are obese.     When obese people eat food they have less response in areas of the brain that sense pleasure     (reward). Decreased pleasure response to food predicts future weight gain. It is not known if     this poor brain response is reversible or why obese people's brains respond this way. Insulin     in the brain regulates the brain's sensing of pleasure. As people gain weight the function of     insulin becomes impaired. The investigators will study if impaired function of insulin is     related to a poor brain response to food and if this brain response predicts voluntary intake     of food and response to a diet. The investigators will also study if improving the function     of insulin with weight loss improves the brain response. These studies will improve the     understanding as to why weight loss is difficult and inform us if improving insulin signaling     is a potential way to treat obesity.   "
79794|NCT02241473|"     By analyzing energetic and biomechanical basis of walking, and the subsequent changes induced     by hypoxic vs normoxic training in obese individuals, it may optimize the use of walking in     hypoxia to gain perspective for exercise prescription to set up training programs that aim to     induce negative energy balance and to deal with weight management. However to the     investigators knowledge, the analysis of changes in mechanics, energetics and efficiency of     walking after continuous hypoxic training (CHT) has not been performed yet.      The aims of the present study were:        1. Comparing the changes in body composition between continuous hypoxic training (CHT) and          similar training in normoxia; e.g. continuous normoxic training (CNT) in obese subjects.        2. Comparing the metabolic and energetics adaptations to CHT vs CNT.        3. Finally, comparing the associated body‐loss induced gait modification since walking          intensity at spontaneous walking speed (Ss) is lower in CHT than in CNT.   "
79785|NCT02241590|"     Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B     Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition     of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and     liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of     hepatic extracellular matrix is still required and hopefully improve the efficacy of     anti-virals for liver fibrotic patients with HBV, especially is necessary for in the patients     with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the     degradation of collagens in fibrotic liver and have a good action against liver fibrosis in     patients with chronic hepatitis B. However, there are no high quality clinical evidences     which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve     the reversion of liver cirrhosis due to HBV.      The primary objective of this study is to establish the safety and efficacy of the     combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients     with liver cirrhosis due to HBV.   "
79786|NCT02241577|"     This study will compare surgical and non surgical treatments of peri-implantitis.     Peri-implantitis is an inflammation around dental implants that can lead to the loss of the     implant over time if no treatment is established. The signs of peri-implantitis included     bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients     presenting with these characteristics will be included at random to one of the treatment     groups. Those allocated to the non-surgical group will received implant cleansing after local     anesthesia using adequate instruments. In the surgical group, patients will be submitted to a     surgical procedure around the implant for visualization and cleansing also after local     anesthesia. All patients will be followed over a 12-month period. The hypothesis is that     surgical treatment is better than non-surgical treatment regarding clinical, radiographic,     microbiological, and immunological.characteristics.   "
79787|NCT02241564|"     The aim of the project is to improve the overall treatment and outcome of renal, pancreas or     liver transplanted patients who have encountered a malignancy by a structured treatment     program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive     treatment, follow-up and evaluation of the program.   "
79788|NCT02241551|"     This is a prospective, randomized phase II trial. Patients diagnosed with borderline     resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms,     either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the     gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged     with CT scans and if they remain borderline resectable or have improvement of their disease     They will then proceed to SBRT followed by surgical resection.   "
82061|NCT02211846|"     The purpose of this study is to evaluate the pharmacokinetics as well as the safety and     tolerability of mirabegron OCAS tablets after single-dose administration at different dose     levels in children and adolescents with NDO or OAB.   "
79789|NCT02241538|"     Low back pain is a major cause of disability and absenteeism and the supervised exercise is a     recommended treatment by the guidelines and has been cost-effective. Currently, the Pilates     method has shown to be effective in improving pain and disability in patients with chronic     low back pain (CLBP). However, there is still no evidence about the ideal number of sessions     for the treatment and the interval between sessions to achieve better efficacy of this method     for these patients. Thus, the aim of this study is to investigate the effectiveness of the     Pilates method with different weekly frequency of sessions in the treatment of patients with     nonspecific CLBP. Investigators will assess 296 patients of both genders, with nonspecific     CLBP lasting more than three months and aged between 18 and 80 years. Participants will be     randomly divided into four groups (n = 74 patients per group): Control Group will receive an     educational booklet and no additional exercise, Pilates 1 Group will receive a program of     exercises based on Pilates method once a week for six weeks, Pilates 2 Group will receive the     same program of exercises twice a week for six weeks and Pilates 3 Group will receive the     same program of exercises three times a week for six weeks. The outcomes overall disability     (Roland Morris Disability questionnaire), specific disability (Patient-Specific Functional     scale), kinesiophobia (Tampa scale for kinesiophobia), pain intensity (Pain Numerical Rating     scale) and global perceived effect (Global Perceived Effect scale) will be assessed by a     blinded assessor before, six weeks, six and 12 months after randomization. Investigators     expect that the largest number of weekly sessions of Pilates method may influence the results     in all analyzes (short, medium and long term), since there is a relationship between     frequency of exercises and effect size of the treatment.   "
79790|NCT02241525|"     Examine the feasibility and efficacy of individually optimized uniform contrast enhancement     in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.   "
79791|NCT02241512|"     Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique     utilized to diagnose and treat pathologic conditions involving the ducts draining the liver     and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and     occurs in approximately 11% of children undergoing the procedure. By definition it leads to     prolongation of hospital stay or delays in care and rarely can result in long-term morbidity     or even death. Recent adult trials have demonstrated prevention of PEP with administration of     rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed     in children thus no gold standard or even commonly accepted method of preventing PEP in the     pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages     over rectally administered NSAIDs in the pediatric population in that it would allow for more     consistent weight based dosing and would have more predictable absorption compared to     suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV     ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is     a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls     (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical     Center Dallas over a two-year period. The primary outcome measurement will be development of     PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be     measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease     rates of post-ERCP pancreatitis in pediatric patients.   "
79792|NCT02241499|"     In this trial, patients with histologically proven adenocarcinoma of the esophagus or     esophagogastric junction noneligible for surgery or chemoradiation with curative intent will     be included. Primary objective is to determine the rate of improvement in dysphagia after     palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy     consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated     by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be     an improvement.   "
79793|NCT02241486|"     The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray     (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn     injury.   "
79795|NCT02241460|"     The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine     Spray compared with placebo in patients with premature ejaculation.   "
79796|NCT02241447|"     The purpose of this study is to narrow the gap between patients being diagnosed with severe     aortic stenosis and those being appropriately monitored and treated. For this purpose a     prospective survey of current practice (3 months) will be conducted followed by a six month     period of intervention during which a variety of quality improvements measures will be     implemented. There will then be a 3 month follow-up period during which the legacy of this     initiative will be monitored during which no intervention will be carried out.   "
79797|NCT02241434|"     The purpose of this study was to study the effect of stem cell therapy in patients with     Duchenne Muscular Dystrophy.   "
79798|NCT02241421|"     BACKGROUND: The relation between gut microbiota and obesity originates from animal studies,     showing that the change of gut microbiota can induce changes in both insulin resistance and     body composition. In addition, these studies have shown changes in gut permeability inducing     a pro-inflammatory state, changes in adipose tissue function and inflammation, effects on     energy harvesting and metabolism, skeletal muscle fatty acid partitioning and fat oxidation.     Human data is lacking, although several studies suggested that the composition of the gut     microbiota differs between lean and obese, and between diabetic and non-diabetic individuals.      OBJECTIVE: To provide insight in the physiological significance and underlying mechanisms     involved in the relation between gut microbiota, energy balance and insulin sensitivity in     overweight men with impaired glucose homeostasis.   "
79799|NCT02241408|"     The purpose of this study is to determine the impact that treatment with a cellular     concentrate derived from an individual's own fat, known as the stromal vascular fraction     (SVF), has on joint pain and functionality in people with Osteoarthritis (OA). SVF contains     components with regenerative properties, including stem cells that have shown promise for     ameliorating specific disease conditions. This study is designed to evaluate joint pain and     functionality changes in individuals with OA for up to 12 months following SVF treatment.   "
79800|NCT02241395|"     The purpose of this study was to study the effect of autologous bone marrow mononuclear cells     on common symptoms of cerebral palsy patients.   "
79813|NCT02241226|"     It is becoming increasingly recognized in the literature that ancient practices for     wellbeing, including meditation, yoga, and specific herbs, can improve health and promote     longevity. While studies have documented such effects for a variety of individual practices     for wellbeing, few studies have taken a more whole systems approach that is simultaneously     inclusive of numerous practices. This intervention study, the Self-Directed Biological     Transformation Initiative, will examine the effects of a comprehensive whole systems     approach to wellbeing on key biochemical, physiological, and psychosocial endpoints.     Participants randomized to the Perfect Health program at the Chopra Center for Wellbeing will     be compared to individuals not taking the program.   "
79801|NCT02241382|"     Implantation of internal defibrillators, capable of monitoring the heart and shocking life     threatening arrhythmias back to normal rhythm, for patients with severe heart failure     increases the probability of survival. Arrhythmias of the atria of the heart are common in     these patients. Administering a direct current electrical shock under anesthesia     (cardioversion) is the method of choice to reestablish normal sinus rhythm in this instance.     Safety and efficacy of external electrical cardioversion (CV) in patients with ICDs was     demonstrated in several studies. Safety of internal cardioversion (shocking the heart back     into normal rhythm via the implanted defibrillator) was described in several smaller trials.      Performing external instead of internal cardioversion in patients with implanted ICDs is more     feasible for most hospitals, as CV can be performed without a programming computer and an     additional specialist present, e.g. on the intensive care ward, and device interrogation can     be done after CV at the remote ICD/pacemaker clinic.      No scientific data on safety and efficacy endpoints comparing internal vs external CV is     currently available. The aim of the study is to compare external vs internal electrical     cardioversion for atrial arrhythmias and establish a safety and efficacy profile for external     and internal cardioversion in large cohort of ICD patients.   "
79803|NCT02241356|"     Visual acuity at near improves in children with Down syndrome using bifocals   "
79804|NCT02241343|"     Problems affecting the veins in the legs can cause discomfort and swelling. We want to see     how artificially and reversibly blocking the leg veins affects swelling in the lower limb.   "
79805|NCT02241330|"     The objective of this research is to test the efficacy of Zn biofortified wheat in increasing     Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.   "
79806|NCT02241317|"     Development of a training concept for health care professionals (nursing and medical staff),     according to the current guidelines on treatment of in-patients with Diabetes. Primary     endpoint is the change in hypoglycaemia rates comparing data before and after the training.     Hereby we can derive the effects of staff training on the quality of health care in this     patient population.   "
79807|NCT02241304|"     TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular     monitoring system intended for daily clinical use. The primary aim of this clinical     investigation is to examine the applicability (ease of use, equipment need, etc.),     repeatability (precision or internal consistency) and performance (signal quality, accuracy     of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph     device in patients undergoing elective surgeries requiring neuromuscular blockade.   "
79808|NCT02241291|"     The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural     data as well as to assess the clinical outcomes of all patients undergoing percutaneous     coronary intervention (PCI) at Bern University Hospital. All patients undergoing PCI with or     without stent implantation will be prospectively registered. Device use is according to the     decision of the treating physician and independent of this registry. At hospital discharge     and one year, the following outcomes will be assessed: death, cardiac death, myocardial     infarction, stent thrombosis, repeat revascularisation, stent thrombosis, stroke, bleeding,     renal failure and vascular complications.   "
79843|NCT02240836|"     The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise     program comprised of strength and endurance training among newly diagnosed breast cancer     patients undergoing adjuvant therapy, will influence factors associated metabolic profile,     tumor growth and cardiopulmonary function. Secondary aims are to determine whether the 12     month exercise program will influence disease-free survival, overall mortality and breast     cancer specific mortality. Furthermore, the effect on QoL parameters, and dietary factors     will be assessed and evaluated.   "
79860|NCT02240615|"     Prospective, open label, multi-center, non-randomized study designed to collect initial     clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent     for use during repair of the lacrimal system in patients with functional or obstructive     epiphora.   "
79809|NCT02241278|"     The analgesic properties of ketamine are associated with its non-competitive antagonism of     the N-methyl-D-aspartate receptor; these receptors exhibit an excitatory function on pain     transmission and this binding seems to inhibit or reverse the central sensitization of pain.     In the literature, the value of this anesthetic for preemptive analgesia in the control of     postoperative pain is uncertain. The objective of this study was to ascertain whether     preoperative low-dose ketamine reduces postoperative pain and morphine consumption in adults     undergoing colon surgery.      In a double-blind, randomized trial, 48 patients were studied. Patients in the ketamine group     received 0.5 mg/kg intravenous ketamine before surgical incision, while the control group     received normal saline. The postoperative analgesia was achieved with a continuous infusion     of morphine at 0.015 mg∙kgˉ¹∙hˉ¹ with the possibility of 0.02 mg/kg bolus every 10 min. Pain     was assessed using the Visual Analog Scale (VAS), morphine consumption, and hemodynamic     parameters at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively. We quantified times to     rescue analgesic (Paracetamol), adverse effects and patient satisfaction.   "
79810|NCT02241265|"     The investigators hypothesis is that there will be improvement in FEV1 in patients with     severe asthma.   "
79811|NCT02241252|"     This study will validate the recording accuracy of a specific electrical interval of the     heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead     electrocardiogram (ECG). These measurements will occur in hospitalized patients that are     starting either sotalol or dofetilide, since both of these medications can prolong the QT     interval.   "
79812|NCT02241239|"     There are many risk prediction models. And their estimates are different. This study aimed to     investigate the differences between the estimates of Fuwai and Reynolds risk model in     Chinese, and investigate the reason for the differences.   "
79824|NCT02241083|"     Vasopressors may be needed after head and neck microvascular reconstructions to maintain     sufficient mean arterial pressure. This is crucial for the flap survival. The study     hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue     oxygen level and microdialysate metabolites.   "
80073|NCT02237794|"     The purpose of this study is to determine the effect of medical treatment on longitudinal     myocardial function. Patients who have been hospitalized for reasons other than heart disease     will be examined with Transthoracic Cardiography before and after medical treatment to     determine change in myocardial function.   "
79814|NCT02241213|"     Aphasia is one of the most disabling complications in language production in patients with     left hemisphere stroke. About 19% of patients who experience aphasia may have a spontaneously     recovery after several weeks or months. Some studies have reported that repetitive low     frequency Transcranial Magnetic Stimulation (TMS-r) in patients with ischemic stroke     generates left modulation of cortical excitability by facilitating and promoting functional     reorganization and recovery of language production. In spite of this, most of the studies in     patients with post-stroke aphasia, are small cases series without controls that correspond to     a descriptive design and does not perform long-term follow up. Currently the population is     heterogeneous respect to etiology, type of stroke and aphasia severity; also several authors     have concluded that the exact location of the site, would be possible through the     neuronavigation technique, to obtain better results.      OVERALL OBJECTIVE Determine the efficacy of repetitive low-frequency TMS on oral language     recovery in post-ischemic stroke patients with non-fluent aphasia      ESPECIFIC OBJETIVES        -  Estimate the effect of repetitiveTMS treatment on right Lowe Frontal Gyrus (GFI), in the          evolution of the neuropsychological language test results in patients with non-fluent          aphasia, compared to placebo.        -  Describe the behavior of depression and anxiety levels in both treatment groups (active          and placebo), through Zung anxiety and depression test, to establish their correlation          with production testing language.        -  Evaluate the effect of repetitiveTMS technique compared to placebo, on the overall          functionality of the subject through Barthel scale.        -  Describe the impact of language behavior on the quality of life of patients treated with          placebo and active EMT, assessed by the EuroQol test.      METHODOLOGY A placebo double blind controlled and randomize trial, to evaluate the efficacy     of low frequency EMT-r in language recovery in 100 patients with first ischemic stroke event     among the first 4-8 months postinfarction and non-fluent aphasia. The patient will agree and     will sign the informed consent, in order to application aphasia diagnosis Boston test,     Edinburgh test, Barthel scale, Zung anxiety and depression test, and EuroQol scale, Neuropsi.     Subsequently the subjects will be randomizate to any of two arms of the study. A week before     the start of the stimulation sessions, the following tests will be applied to assess language     production: Boston Test and Verbal Fluency (FAS). Each patient will have a daily session     EMT-r low-frequency active or inactive coil with a biphasic stimulator pulses applied for ten     days in two weeks on the triangular area - homologous to injury Lower Front Gyrus (LFG),     (right brain hemisphere). Complete the treatment schedule of two weeks, the language     production will be evaluate again, and also scales as Barthel an Rankin-m, Zung anxiety and     depression and EuroQol. This monitoring will be achieved in five stages: after one week, one     month, 4 months, 8 months and 12 months post-stimulation, with the intention of determining     the duration and effectiveness effects in language production of the EMT-r.   "
79815|NCT02241200|"     The main purpose of the study is to determine whether the test product and the reference     product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a     single intravenous dose and as a single subcutaneous dose of each of the formulations. The     study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.   "
79816|NCT02241187|"     This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab     given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In     Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be     studied. Also, the effects of PEGPH20 on tumors will be studied.   "
79817|NCT02241174|"     This study will determine the safety and efficacy of diluted bleach bath solution as final     rinse on the reduction of Staphylococcus aureus colonization among children and adult     Filipinos with mild to moderate atopic dermatitis..   "
79818|NCT02241161|"     Aim of the study was to evaluate the soothing and re-epithelizing activity of a single     application of topical products on experimentally induced erythema by skin stripping on the     forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following     three cosmetic products and the relative combinations (cream and serum) were assessed:     rejuvenating cream, rejuvenating serum, antioxidant serum   "
79819|NCT02241148|"     The investigators will include patients attending outpatient clinic in the area of     Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral     Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting     unilateral PFPS with six months of evolution, presenting anterior or retro knee pain that     presents itself when undergoing two or more of the following activities: squatting, running,     kneeling, jumping, or climbing stairs; physically active patients, with at least thirty     minutes of physical activity at least three times per week. Exclusion criteria include     patients with previous knee surgeries, chronic pain with more than one year of evolution,     pregnancy or suspected pregnancy, application of intra-articular steroids in the three months     prior to their evaluation, patients with meniscal injuries, ligament or intra-articular knee     structures, degenerative diseases such as diabetes, rheumatoid arthritis, OA of the knee, hip     or ankle, history of dislocation or subluxation of patella, Osgood Schlatter syndrome and     patellar tendinitis or quadriceps.      The investigators will divide patients into two groups. The control group will receive     treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and     stretches at home intended for the strengthening of quadriceps, abductors and internal     rotators of the hip for the duration of six weeks. The experimental treatment group will     receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ®     Kinesio taping on the affected knee. Both groups will be evaluated by an external     consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the     WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the     beginning, third and sixth week. The patients in the experimental group will be quoted each     week to change the tape. The control group will be quoted at the beginning, at three weeks     and after six weeks. During the first appointment we will take patients anthropometric     measurements (weight, height, BMI) as well as general information. Radiographic studies     (anteroposterior and lateral knee, plus the projection Merchant) will be sought to rule out     other diseases and see the degree of contact of the patella on the patellofemoral joint. All     patients will receive an explanation about their illness, and a booklet with the required     exercises as well as their frequency.      For patients to be included in the group of Spider ® Taping, Kinesio Tape pre-cut strips that     were placed inferior to the head with no pressure applied, then two bands are placed at the     ends of the tape and crossed on the edges of the patella and ending at the thigh to finish     applying moderate tension to place them, then two strips were placed at each end of the edges     of the first and second tape without applying pressure. The tapes can last up to five days on     the extremities while maintaining their purpose, patients included in this group will be     summoned each week to remove the tapes and place new ones.   "
79820|NCT02241135|"     The purpose of this trial is to assess the safety and immunogenicity of an investigational     RNActive® rabies vaccine (CV7201) in healthy adults.   "
79844|NCT02240823|"     Prostate cancer is the most common cancer among Danish men, and the incidence is increasing.     Studies have shown a high number needed to treat for each saved prostate cancer related     death. Since the treatments incur many complications, there is a need to address these. After     prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's     identity, self-esteem and quality of life. Stem cells have generated a large amount of     promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating     nerves as well as endothelial and smooth muscle cells in the corpus cavernous.   "
79845|NCT02240810|"     To compile acute procedural performance and clinical outcomes data for the Promus PREMIER     everolimus-eluting coronary stent system in understudied/underserved patient populations     including women and minorities.   "
79821|NCT02241122|"     Prostate cancer has been the most common neoplastic disease in men in Finland over the last     ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate     cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.     Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)     guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed     instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there     is an increasing interest in developing more accurate non-invasive imaging modalities.      This prospective multi-institutional study will enroll 400 men with clinical suspicion of     prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital     rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted     imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to     non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided     biopsy based on MRI findings will be performed in addition to routine twelve core TRUS     biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from     fresh biopsy sample will be collected and correlated with the presence or absence of prostate     cancer.   "
79822|NCT02241109|"     Aortic stenosis is the most common valvular heart disease and an important public-health     problem. Surgical or interventional aortic valve replacement are based on symptoms and     measures of valvular and ventricular function using echocardiography.There is no uniform     pattern of progression. Instead, marked differences not only between individuals, but also     during the time course of the disease can be observed.      Several prospective studies have been performed to enhance the predictability of disease     behavior. Individually it is still prone to large errors and hard to predict aortic stenosis     progression. Therefore, in patients with aortic sclerosis without severe stenosis, it is     desirable to find a strong predictor of rapid disease progression. This would allow     anticipating cardiovascular deterioration by identifying individuals at particular risk.      Study Hypothesis      In patients with aortic sclerosis, increased serum calcification propensity, as measured by     the T50-Test, is related to the amount of stenosis progression in one year.   "
79823|NCT02241096|"     To determine safe concentration level of lidocaine infusion in children.   "
80610|NCT02230995|"     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose     combination (FDC) tablet containing empagliflozin and metformin extended release compared to     the free combination of empagliflozin and metformin extended release under fed conditions.   "
79827|NCT02241044|"     Background:      A second endoscopic method added to injection therapy is recommended for high-risk bleeding     peptic ulcers. Many endoscopic devices have been proved as useful hemostatic instruments,     whereas the hemostatic efficacy of argon plasma coagulation (APC) has not been widely     investigated.      Aim:      This study was designed to know whether additional APC treatment could influence the     hemostatic efficacy after endoscopic injection therapy in treating high-risk bleeding ulcers.      Methods:      From October 2010 to January 2012, eligible patients who had high-risk bleeding ulcers were     admitted to our hospital. They prospectively randomly underwent either APC therapy plus     distilled water injection or distilled water injection alone. Pantoprazole infusion was     conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer     healing. Episodes of rebleeding were retreated with endoscopic combination therapy. Patients     who did not benefit from retreatment underwent emergency surgery or transarterial     embolization (TAE).   "
79828|NCT02241031|"     The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic     progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by     chemotherapy in patients with acute leukemia (AL).   "
79829|NCT02241018|"     The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and     calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients     with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic     stem cell transplantation.   "
79830|NCT02241005|"     Healthcare-associated infections (HAI) are associated with substantial morbidity, mortality     and health-care costs in children undergoing hematopoietic stem cell transplantation (HSCT).     These infections are often caused by a patient's own microbial flora. Hence reduction of     microbes in the skin could lessen the risk of contamination of central venous catheters,     Central Line Associated Blood-Stream Infections (CLABSI), and bacteremia due to compromise of     skin integrity.      Theraworx™ (herein referred to as experimental wipes) is a self-drying, leave on cleansing     agent that combines a specialized surfactant with skin healthy ingredients, including aloe,     allantoin, vitamin E, and silver, which is the main antimicrobial ingredient. It can be used     on all parts of the body including burns, abraded skin, and on patients with skin     graft-versus-host-disease (GVHD). It is user friendly and obviates the risk of antimicrobial     resistance. Microbiologic studies have shown several log fold reduction of bacteria including     vancomycin-resistant enterococci, carbapenem resistant Escherichia coli, and activity against     Staphylococcus aureus, Enterococcus faecalis, Clostridium difficile, Candida albicans, and     viruses including influenza A and Herpes Simplex. There is no data regarding the use of     Theraworx™ (experimental) bath wipes in children or the HSCT population.      Researchers at St. Jude Children's Research Hospital want to learn if daily bathing with     experimental bath wipes will be well tolerated and associated with reduction in microbial     skin colonization in this population.   "
79831|NCT02240992|"     The purpose of this study is to compare the efficacy of mesenchymal stem cells (MSCs) with or     without granulocyte colony-stimulating factor (G-CSF) mobilized peripheral stem cells (PBSC)     in treating patients experiencing poor graft function or delayed platelet engraftment after     allogeneic hematopoietic stem cell transplantation.   "
79832|NCT02240979|"     The purpose of the study is to evaluate a new way to examine cardiac function, using software     developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is     used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where     the carotid pulse can be felt. In this study the information collected from the iPhone app is     compared to cardiac function data obtained from the current gold standard for measuring     cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from     cardiologists will also generally have echocardiography information available for comparison     with the iPhone app. For the study, subjects will have completely non-invasive studies done     in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist)     arteries), tonometry (another non-invasive method using a modified stethoscope), standard     pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study     will be done about 6 months after the first. The complete study session takes about 1.5     hours.   "
79833|NCT02240966|"     The purpose of this study is to investigate the prevalence of signs and symptoms of     hypogonadism in three groups of testicular cancer survivors.   "
79834|NCT02240953|"     Prosthetic valve thrombosis is a serious complication with high mortality and morbidity.     However, the best anticoagulant treatment strategies for patients with prosthetic heart valve     thrombosis have not been fully known. In this study the investigators wanted to identify the     most effective and safe regimen among different anticoagulant regimens.   "
79835|NCT02240940|"     The design of this study is a multi-center, prospective, single-arm clinical trial to     evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning     system. The purpose of this trial is to use the Parachute percutaneous left ventricular     partitioning system to isolate the malfunctioning portion of the left ventricle in patients     with symptoms of heart failure due to ischemic heart disease and provide the data required to     gain Chinese regulatory approval.   "
79836|NCT02240927|"     Pregnancy is associated with increased risk of thrombosis among women with mechanical     prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant     patients with prosthetic heart valves have been controversial. In this study the     investigators wanted to identify the most effective and safe regimen among different     anticoagulant regimens.   "
79837|NCT02240914|"     -  Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct          and indirect ultrasonographic signs, in the obstructive diseases of iliac venous          segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering          the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.        -  Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in          the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).   "
79866|NCT02240537|"     The study is designed to evaluate safety, immunogenicity, and preliminary anti-tumor activity     of a multi-peptide immunotherapy (BB-MPI-03) at three peptide+adjuvant dose levels. The     peptides stimulate cytotoxic T-cells targeting oncofetal antigen (OFA). Subjects with AML,     MM, sMM, or MDS who are off treatment and with stable disease or better, or who are not     eligible for or refuse allogeneic HSCT are to be enrolled. The study will be conducted at 2     to 4 study centers in the US.   "
79838|NCT02240901|"     Perioperative airway management is a top priority of anesthesiologists in daily work, and     endotracheal intubation (ETI) is considered as the gold standard for providing safe glottic     seal,effective ventilation and oxygen supplement during general anesthesia. But ETI related     complications such as concomitant hemodynamic responses, damage to the oropharyngeal     structures at insertion and postoperative sore throat. Laryngeal mask airway(LMA) for the     anesthesia management brings new choice with invasive, lighter cardiovascular reaction and     many other advantages, particularly suited to short and minimally invasive surgery. But LMA     increased the risk of gastrointestinal reflux aspiration than using ETI and it may resulted     in intolerance in high airway pressure, especially in elderly patients with increased lung     compliance or reduced airway resistance. Furthermore, LMA could not entirely prevent the     occurrence of postoperative sore throat and hoarse.      To sum up, it is necessary to carry out a multicenter clinical trial to clarify the safety of     LMA in elderly patients. The investigators protocol will focus on the incidence of     postoperative pulmonary complications (PPCs) when applications of LMA and ETI in elderly     patients.   "
79839|NCT02240888|"     The overall objective of this project is to study the influence of modern anti-inflammatory     treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited     by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In     addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in     immunosuppressed patients with IRD, impact on existing rheumatic disease, possible     association with onset of new autoimmune diseases, long-term immunity following pneumococcal     vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related     serious infections. Results from this study are expected to bridge the existing knowledge gap     and contribute to body of evidence needed for recommendations and implementation of     vaccination program in IRD patients.   "
79840|NCT02240875|"     The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different     doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to     assess the safety of the vaccines and the extent of the immune response in healthy     volunteers. The investigators will do this by giving volunteers a either one or two     vaccinations, doing blood and saliva tests and collecting information about any symptoms that     occur after vaccination. This is the first trial to use either of these vaccines in humans.     We plan to recruit a total of 92 volunteers to be vaccinated.   "
79841|NCT02240862|"     The objective of C2R is to promote the rapid initiation and completion of enrollment in the     CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe     symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid     artery stenting (CAS) performed by experienced and skilled interventionists.     Interventionists' eligibility will be determined by a multi-specialty Interventional     Management Committee (IMC). Patient eligibility will include patients with standard or     high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for     the occurrence of post-procedural complications. The primary safety and quality endpoint will     be the occurrence of any stroke or death within the 30-day period following the stenting     procedure. The safety and quality results from C2R will guide selection of interventionists     for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in     2015 and continue until publication of the primary results of the randomized trial.   "
79842|NCT02240849|"     The purpose of this study is to investigate the effects of functional cervical pillow on     inpatients with neck discomfort.   "
79848|NCT02240771|"     In India, majority of our patients have advanced hepatocellular carcinoma (HCC) at     presentation and hence are unsuitable for the available curative treatment options. In such     patients the treatment options are mainly palliative. Transarterial chemoembolization (TACE),     transarterial chemotherapy (TAC) and various forms of oral chemotherapy are the only     available options currently. Many patients have more advanced disease with the involvement of     branches of portal vein. This further limits the therapeutic options. According to Barcelona     Clinic Liver Cancer (BCLC) staging, involvement of portal vein precludes any standard form of     therapy. TAC and oral chemotherapy has been tried in this group of patients by few     researchers. Which treatment (TAC or oral chemotherapy) would be better suitable for advanced     stage (BCLC C) needs to be explored. However, there are no randomized controlled trials     (RCT's) available.      TAC is the procedure for treating patients of HCC with portal vein invasion where only the     chemotherapeutic drugs are injected into the feeding vessels of the tumor with no subsequent     embolization of the feeding vessels.      In order to select a modality which would produce better outcomes in advanced HCC patients     (BCLC C), this study was planned.   "
79849|NCT02240758|"     Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain     lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and     real-time assessment of resections margins during surgery. Probe-based CLE using the     CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the     potential of this technique in improving surgical resection outcome, a feasability study has     to be performed.   "
79850|NCT02240745|"     The investigators are going to recruit patients who have a scheduled elective coronary     angiography and going to do a dobutamin stress echography (DSE) before the coronary     examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE,     incl ventriculography. In the interventional part (coronary angiography), they will measure     each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.   "
79867|NCT02240524|"     The purpose of this study is to study the efficacy of hyperthermic intraperitoneal     chemotherapy in the treatment of patients with locally advanced gastric cancer after radical     gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.   "
79868|NCT02240511|"     Heart Failure (HF) is a complex syndrome which can include the physiological, neural hormonal     and metabolic complications known as Cardiac Cachexia (CC). In the development of CC there     is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and 6)that cause     a decrease of fat free mass and fat mass. These changes in body composition might be reversed     with a therapeutic combination of resistance exercise and branched chain amino acid     supplementation (BCAA). Thus the purpose of this study is evaluate changes in body     composition after a resistance exercise program and BCAA supplementation in patients with HF.   "
79851|NCT02240732|"     BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England,     Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a     surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's     leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can     therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative     tourniquet can therefore help to improve the surgical field of view. Although the majority of     surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are     now not pursuing these devices.      There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet     is used for TKR surgery. In addition embolic material in the venous system have been observed     following TKR surgery and have been noted to be present in the right atrium with     transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening     emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous     shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical     manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood.     Fat embolism syndrome and post-operative confusion in TKR patients may be the result of     emboli formed during a TKR. ,      AIM        -  Is there evidence of emboli entering the cerebral circulation following tourniquet          deflation in TKR surgery?        -  Is there evidence of MRI detectable brain lesions and or any clinical change in          cognition compared in patients undergoing TKR surgery with a tourniquet compared to          those that do not have a tourniquet?   "
79852|NCT02240719|"     This phase I trial studies the side effects and the best dose of everolimus when given     together with bendamustine hydrochloride in treating patients with cancer of the blood     (hematologic cancer) that has returned after a period of improvement (relapsed) or did not     get better with a particular treatment (refractory). Everolimus may prevent cancer cells from     growing by blocking a protein that is needed for cell growth. Drugs used in chemotherapy,     such as bendamustine hydrochloride, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving everolimus together with bendamustine hydrochloride may be a better     treatment for hematologic cancer.   "
79853|NCT02240706|"     Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability,     pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients     with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia.     Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared     to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic     anemia without a deletion 5q cytogenetic abnormality.   "
79854|NCT02240693|"     The study is designed to compare the effects of 4 different doses of orally administered BI     409306 to placebo in patients with Alzheimers Disease   "
79855|NCT02240680|"     To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day     compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in     elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient     glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors     is also allowed.      In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when     added to background basal insulin therapy. The treatment duration of this trial (24 weeks)     will enable assessment of the clinically relevant endpoint of a decrease in glycosylated     Haemoglobin, a well-accepted measurement of chronic glycaemic control.   "
79856|NCT02240667|"     1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12     months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for     definitive treatment discontinuation will be collected. At 6 months, patient adherence will     be assessed, using the Morisky Score.   "
79857|NCT02240654|"     This is a descriptive, observational, multi-country European cross-sectional study of new     users of dabigatran etexilate that aims to characterise on- and off-label status and other     medical characteristics at the time of the first captured prescription of dabigatran     etexilate in each database. The study will be conducted using Cegedim Strategic Database     (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink     (CPRD, UK).   "
79863|NCT02240576|"     We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the     history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a     retrospective analysis of 310 patients with a nasal fracture in the past would be useful to     investigate the incidence of IR in this cohort afterwards (5-10 y later).   "
79864|NCT02240563|"     INTRODUCTION: Chronic autoimmune thyroiditis (TCA) is the main cause of acquired     hypothyroidism, which requires continuous treatment with levothyroxine (LT4). A randomized,     placebo-controlled trial including 43 patients with hypothyroidism caused by TCA without     nodules on ultrasonography study (US) was conducted from March 2006 to March 2009     (NCT01129492). Among them, 23 were submitted to low-level laser therapy (LLLT) and 20 to     placebo. The LLLT was effective in improving the echogenicity, the volume and of the thyroid     vascularization pattern by US. There was also improvement in the thyroid function and     reduction of serum thyroid peroxidase antibodies (TPOAb). Although the results have shown     promising and LLLT has shown to be safe in many study models, the long-term LLLT actions on     the thyroid parenchyma are unknown. Thus, the objective of this study is to perform     biochemical tests and thyroid US six years after the clinical trial interventions to evaluate     levothyroxine dose, serum levels of autoantibodies and, especially, the frequency and nature     of nodules in the gland and then compare these variables between LLLT and placebo groups.     METHODS: This study will include the trial participants performed six years before. The     levothyroxine dose and serum levels of thyrotropin (TSH), T3, T4, free T4, TPOAb and     anti-thyroglobulin antibodies (TgAb) will be evaluated in these patients. The thyroid US will     assess the texture (with particular attention to identifying nodules), echogenicity, volume,     as well as vascularization of the gland. The US nodules features, such as dimensions, shape,     margins, extracapsular invasion, echogenicity, texture, hypoechoic halo, calcification,     internal content, vascularization pattern and resistivity index will be searched. Regional     lymph nodes and other characteristics will be also investigated. The USs will be carried out     by only one examiner who will be blinded for the previously performed intervention (LILT or     placebo). The same investigator will execute a fine needle aspiration (FNA) of patients with     thyroid nodules. The cytological analysis of the material collected from the nodules will be     undertaken by a pathologist who will be also blinded for the treatment assignments. RESULTS:     The following variables will be compared between the two groups: levothyroxine doses,     antithyroid antibodies, US parameters, thyroid nodules (if detected) and in this case, the     result of their respective FNA.   "
79865|NCT02240550|"     This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner)     prospective study designed to collect perioperative and postoperative data to compare the QOL     of ProFlor vs. Lichtenstein inguinal hernia repair.   "
80611|NCT02230982|"     To provide early access and to evaluate the safety and tolerability of nintedanib in patients     with idiopathic pulmonary fibrosis (IPF)   "
79869|NCT02240498|"     The objectives of this Phase 1 study are to evaluate the safety and feasibility of     methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess     drainage to treat deep tissue abscesses. Safety will be evaluated by physical examination and     imaging and laboratory studies in order to identify adverse events that may be induced by     MB-PDT. We hypothesize that MB-PDT will be a safe and feasible intervention for this patient     population.   "
79870|NCT02240485|"     The aim of the study is to compare marital treatment to individual treatment for pathological     gambling.   "
79872|NCT02240459|"     The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses     versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people     with overactive bladder and mild cognitive impairment.   "
79873|NCT02240446|"     The overarching goal of this project is to expand the traditional expertise in non-invasive     neuromodulation at the University of Minnesota towards developing novel neuromodulation     approaches using transcranial direct current stimulation (tDCS) for treating schizophrenia     patients with medication-resistant auditory hallucinations. The investigators will use tDCS     to stimulate prefrontal cortex. TDCS is a non-invasive brain stimulation technique that can     modulate brain connectivity. Non-invasive brain neuromodulation will be combined     (paired-neuromodulation) with training of a task that requires top-down control of auditory     processes. Paired-neuromodulation can potentially be used as a therapeutic intervention to     decrease auditory hallucinations in schizophrenia.   "
80004|NCT02238704|"     The World Health Organization (WHO) now recommends prenatal calcium supplementation for     prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to     compare the effect of two dosing strategies on the amount of supplement ingested by pregnant     women and adherence to related recommendations.   "
79875|NCT02240420|"     The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base     counseling intervention for young Latino women who are at high risk of diabetes. The     intervention will focus at the end of pregnancy and the 9 months post-partum period to     improve education and behavioral counseling on nutrition and other related health topics .      The following hypotheses will be formally tested:      Compared with controls at 9 months post-partum:        1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for          minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);        2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;        3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.      Women in the STAR-MAMA will have lost more weight than women in the control group.   "
79876|NCT02240407|"     A recombinant AAV vector has been generated to carry the codon-optimized acid     alpha-glucosidase (coGAA) gene expressed from a human desmin enhancer/promoter (DES). The     proposed clinical trial is a within-participant, double-blind, randomized, phase I controlled     study evaluating the toxicology, biodistribution and potential activity of re-administration     of rAAV9-DES-hGAA injected intramuscularly into the TA. Nine participants (18 to 50-years     old) who reside within the United States with Late-Onset Pompe Disease (LOPD) will be     included. The goal of the immune modulation strategy is to ablate B-cells (Rituximab and     Sirolimus) prior to the initial exposure to the study agent in one leg and the subsequent     exposure of the same vector to the contralateral leg after four months. At each study agent     dosing, the contralateral leg will receive excipient. Patients will act as their own     controls. Repeated measures, at baseline and during the following 3 months after each     injection, will assess the safety, biochemical and functional impact of the vector.   "
79877|NCT02240394|"     Increased intracranial pressure is a cause of disease progression in patients with brain     disease, a common cause of poor prognosis. Intracranial pressure monitoring is the     observation of the disease, treatment, evaluation and important way to improve the prognosis.     Non-invasive intracranial pressure monitoring can be used to stroke, intracranial hemorrhage,     brain trauma, encephalitis and other patients. Ophthalmic artery originated from the internal     carotid artery, the optic canal into the orbit, the entire process can be divided into     intracranial optic tube segment and orbital segment. investigators' preliminary experiments     show that when intracranial pressure, intracranial ophthalmic artery segment velocity     increases with increasing velocity difference orbital segment. Accordingly, the investigators     speculate, may be judged by the level of intracranial pressure intracranial and orbital     velocity difference between the ophthalmic artery segment, and accordingly calculate the     specific values of intracranial pressure. The investigators will collect brain trauma     surgery, performed invasive intracranial pressure monitoring cases, the use of transcranial     Doppler ultrasound velocity and different segments of the ophthalmic artery pulsatility     index, the invasive intracranial pressure and comparing the measured values to calculate the     the critical value of the ophthalmic artery segment intraorbital and intracranial velocity     difference when intracranial pressure, thus fitting Based on projections of mathematical     formulas intracranial pressure. This study will provide a non-invasive intracranial pressure     monitor new approach.   "
79878|NCT02240381|"     This clinical trial studies the physiology and immunology of new-onset post-transplant     diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose     tolerance testing (OGTT), euglycemic hyperinsulinemic clamps, and immune assays will be used     to define the mechanisms associated with abnormal glucose homeostasis following stem cell     transplantation. Information from this clinical trial could be used to develop standardized     screening procedures or to develop optimal treatment strategies for patients developing     post-transplant diabetes mellitus.   "
79879|NCT02240368|"     The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors     agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in     relationship with the age in the pediatric surgery setting.      Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established     in adult general anesthesia.      Their utility is yet undefined in the pediatric population as age seems to affect their     ability to track the cerebral hypnotic state in children.   "
79880|NCT02240355|"     This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study     will investigate the safety and tolerability of RO6885247 in adult and pediatric patients     with spinal muscular atrophy (SMA).   "
82062|NCT02211833|"     Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose     (MTD), and efficacy of BI 2536 administered in combination with pemetrexed   "
79881|NCT02240342|"     Women delay maternity and, as a consequence, available oocyte number and their quality     decrease (9-18% of all IVF patients). Different treatment protocols have been developed     nevertheless none of them optimal: the number of oocytes retrieved depends on the present     ones. New generation of oocytes and follicles has been defended by some authors and bone     marrow seems to be involved. What seems crucial is the niche that produces paracrine signals     able to activate dormant cells and to attract undifferentiated cells from other tissues     (homing). This phenomenon has been described by our group in other human reproductive tissues     like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women     with poor ovarian reserve by means of bone marrow protective capacity.      Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to     colonize ovarian niche.      The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve     differentiating themselves into germ cells or, more likely, stimulating the niche to activate     dormant follicles.   "
79882|NCT02240329|"     The purpose of this research study is to evaluate coughing in people who have had a brain     injury. It is hypothesized that individuals who have sustained a brain injury will     demonstrate differences in cough waveform and respiratory measures compared to individuals     who have not sustained a brain injury.   "
79883|NCT02240316|"     This observational study aims to assess the therapeutic responsiveness of MabThera SC in     patients with malignant lymphomas under everyday clinical practice conditions. Patients with     previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously     untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy     with MabThera SC according to the assessment of the physician will be prospectively enrolled     for observation. No study specific measures are required; treatment and documentation will be     performed according to usual clinical practice.   "
79884|NCT02240303|"     The aim of this project will be to document the central and peripheral mechanisms, which may     predict clinical pain characteristics and associated physical performance in older adults.     Although chronic pain is common among older adults, there is limited understanding on the     processing of pain and the mechanisms by which it affects physical function in these     individuals. The first aim of this study will be to examine predictors of clinical pain in     older adults. These will include a comprehensive somatosensory assessment battery including     mechanical and thermal detection and pain thresholds in older adults with and without chronic     pain. The investigators will also assess basal cognitive and physical function to determine     their associations with chronic pain. Finally, brain structure and function will be assessed     in these older adults with and without pain.   "
79885|NCT02240290|"     The purpose of the study is to investigate how tozadenant is absorbed, distributed, broken     down and eliminated from the body. The compound to be administered will be radiolabeled. This     enables the investigator to trace the compound in blood, urine, feces, expired air and track     what happens to it.   "
79886|NCT02240277|"     Patients with septic shock may have altered volume of distribution and metabolism of     antibiotics which are crucial medications for treating infections. The aim of the study is to     investigate the blood concentrations of Meropenem and Ciprofloxacin, two commonly used     antibiotics, in patients with septic shock. The hypothesis is that standard dosing may     produce insufficient levels of antibiotics in patients with septic shock.   "
79887|NCT02240264|"     The brain is primarily developed in the third trimester of pregnancy, but continues maturing     through the late twenties, especially the prefrontal cortex. Omega-3 long-chain     polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell     membranes, influence membrane fluidity and signal transduction, and thus learning, cognition     and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with     limitations in these complex brain functions. Previous studies suggested that such functions     could be improved by increasing LCPUFA. The adolescent brain, however, has been largely     neglected. This study investigates the effect of one-year daily omega-3 LCPUFA     supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower     general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority     of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake     of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents     preselected from a population of 700 adolescents with low omega-3 index (<5%) will receive     daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be     adjusted individually to reach a target level of 8-11%. The effects on learning (academic     achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation,     goal-orientation, absenteeism), and in a subsample cognitive processes, in particular     perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months.     This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a     safe intervention, on a large variety of complex brain functions.   "
79888|NCT02240251|"     This is a prospective chart review to follow our laser-assisted IVC filter retrieval     patients. We intend to validate existing literature and scientific findings by publishing our     own clinical experience in difficult IVC filter retrievals.   "
79889|NCT02240238|"     In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities     (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in     combination with gemcitabine.      In the expansion phase of the study (Part 2), study will evaluate the activity, safety, and     tolerability at the RPII dose identified in Part 1 in patients with squamous NSCLC, biliary     tract, and bladder cancer.   "
79890|NCT02240225|"     Assessment of health-related quality of life in COPD patients with severe chronic respiratory     failure requires appropriate and highly specific measurement tools. We attempt to validate     the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)   "
79905|NCT02240030|"     This randomized, multicenter, placebo-controlled, double-blind study will evaluate the     efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing     motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the     clinic.      Patients who successfully complete this study will be eligible to enroll into a 12 month     treatment extension (CVT-301-004E) study .   "
80709|NCT02229487|"     Hypothesis        1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than          those with normal sleep duration.        2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a          standardized meal   "
79891|NCT02240212|"     This is a Phase Ib, open-label, dose-escalation study to determine the Maximal tolerated dose     (MTD) and the recommended Phase 2 dose (RP2D) for the combination of afuresertib and     paclitaxel in subjects with recurrent HER2-negative gastric cancer, and further assess safety     and preliminary efficacy of combination at the RP2D. Afuresertib had showed synergistic     activity when combined with paclitaxel in vitro and in vivo models of gastric cancer. Dose     escalation will continue until the MTD is established. The dose schedule is once daily (QD)     dosing for afuresertib and intravenous (IV) infusion for paclitaxel Dose escalation in Part 1     will follow the 3 + 3 cohort design. A sequential approach will be conducted to explore the     optimal paclitaxel regimen (weekly or 3weekly schedule) when combined with afuresertib. The     dose escalation will be started from Cohort A (afuresertib combined with weekly paclitaxel     regimen at 80 milligram (mg)/meter (m)^2 day1, 8,15, every 4 weeks (q4w). The starting dose     in Cohort A will be 125 mg afuresertib QD. Once its MTD is identified, and then the study     will move to dosing Cohort B (afuresertib combined with 3 weekly paclitaxel regimen at 175     mg/m^2 day1, every 3 week (q3w). The starting daily dose of Cohort B will be 25 mg less than     the MTD dose from Cohort A for afuresertib. If it is tolerated, then the dose escalation     schedule will be followed in Cohort B until the MTD in this Cohort is reached. If the     starting dose is not tolerated, then dose de-escalation will be explored until the MTD in     this Cohort is reached. Once two dimensions of the MTD are achieved, then the optimal regimen     for paclitaxel and MTD for afuresertib combined with paclitaxel based on the toxicity profile     will be identified. The combination regimen at the RP2D selected following Part I will be     further investigated in its efficacy and safety in the Part II Expansion Cohort. Once a     combination dose regimen for Part 2 has been determined, at least 20 and up to 40 subjects     will be enrolled at the dose regimen selected following Part I. Overall response rate (ORR)     will be evaluated using a Green-Dahlberg design. The design consists with one interim     analysis. If less than 3 responses are observed in the initial 20 subjects, enrollment will     be terminated due to futility; otherwise, the study will continue to meet the planned sample     size of 40 subjects.   "
79892|NCT02240199|"     Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves.     During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy     and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves     eventually become abnormal and provide pain signals to the brain well beyond the healing     period after surgery. Patients with these abnormal nerves suffer from chronic pain in the     breast area that persists for several years after surgery. Chronic pain is associated with a     reduced quality of life, daily functioning, psychological distress, and contributes to     excessive health care expenditures. There is encouraging data suggesting that an infusion of     Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the     development of chronic pain after breast cancer surgery. A large randomized controlled trial     is needed to determine the efficacy of these two interventions on reducing chronic pain after     breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to     determine the feasibility of undertaking such a trial.   "
79893|NCT02240186|"     This study will assess if the functional performance and musculoskeletal outcome of     transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a     Non-Microprocessor Knees (NMPK).   "
79894|NCT02240173|"     Sorghum bicolor is a naturally growing plant which has been of health benefit to the people     of West Africa who traditionally prepare its leaf for various nutritional and health     reasons.The food and nutritional fact analysis showed that Jobelyn is rich in Carbohydrates,     Protein, Dietary Fiber, Iron, Natural Vitamins like B12 and Vitamin C. It also contains     Selenium, Omega 3,6 and 9 and other essential elements and fatty acids. Although the     determinants of mental health are complex, the emerging and compelling evidence for nutrition     as a crucial factor in the high prevalence and incidence of mental disorders suggests that     diet is as important to psychiatry as it is to cardiology, endocrinology, and     gastroenterology. Evidence is steadily growing for the relation between dietary quality (and     potential nutritional deficiencies) and mental health, and for the select use of     nutrient-based supplements to address deficiencies, or as monotherapies or augmentation     therapies. There is currently strong advocacy for the recognition of diet and nutrition as     central determinants of both physical and mental health.Its anti-inflammatory and haematocrit     boosting properties have been well documented though the precise mechanism of action is still     largely unknown. Its use has recently been extended to the field of mental health where     findings in animal study suggest it could be of help in relieve of psychosis. The need for     this study is therefore aimed at investigating the effect of this drug in patients with     schizophrenia which is the prototypical psychotic disorder.   "
79895|NCT02240160|"     To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of     Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol     (CBD)) by comparing the PK profile of Sativex in healthy subjects.      The primary clinical hypothesis is that there will be an effect of oral pH on the PK of     Sativex when administered as a single oromucosal dose (four sprays).   "
79896|NCT02240147|"     Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even     though outcomes are good, they need lifelong follow-up because of a higher risk for     cardiovascular diseases. Studies have shown that patients with CHD are not active enough and     that a substantial amount of patients is overweight. Hence preventive strategies and     education should not only focus on the heart problem, but also on a healthy lifestyle     including physical activity. Recently a new guideline introduced exercise prescription based     on the absence/presence of certain key elements. However, a number of important questions     remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport'     program for adults with CHD, based on this new guideline, will be investigated. This study is     a randomized controlled trial that investigates the effects of the program on daily physical     activity, exercise capacity, quality of life and exercise self-efficacy both in short (12     weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by     using a new exercise-testing protocol that looks simultaneously to all body parts that are     involved during exercise. Ultimately, our findings will result in the implementation of the     guideline in clinical practice.   "
79903|NCT02240056|"     Certain cardiac and neurologic diseases influence each other via a still poorly understood     brain-heart axis. Subarachnoidal bleedings are well known to cause ECG alterations     resembling those of myocardial infarction, along with a reduction of systolic myocardial     function (neurogenic stunned myocardium). Alterations of the right insula region by a     stroke or intracranial hemorrhage go along with a sympathetic activation (increased     circulating catecholamine levels, tachycardia, arterial hypertension). In contrast,     alterations of the left insula region often cause vagal reactions such as bradycardia,     arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of     heart attacks, often caused by psychological or physical stress (death of a beloved one,     divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects     postmenopausal women.      Functional MRT enables imaging of activated brain regions, either without (resting state)     or with specific stimuli. The investigators speculate that there is a specific involvement of     the insula region during TTC.   "
79897|NCT02240134|"     Acute lower respiratory tract infections (LRTIs) account for more than 27% of all     hospitalizations among US children under five years of age, with recurrent LRTIs in children     a recognized risk factor for asthma. Residential biomass combustion leads to elevated indoor     levels of fine particulate matter (PM2.5) that often exceed current health-based air quality     standards. PM2.5 exposure is associated with many adverse health outcomes, including a     greater than three-fold increased risk of LRTIs. To date, exposure reduction strategies in     wood stove homes have been either inconsistently effective or include factors that limit     widespread dissemination and continued compliance in rural and economically disadvantaged     populations. In this project, the investigators propose to test the efficacy of two     intervention strategies for reducing indoor wood smoke PM2.5 exposures and children's risk of     LRTI in three unique and underserved settings: (1) rural mountain valley communities in     western Montana; (2) Navajo Nation communities; and (3) Alaska Native Villages. The     investigators will conduct a three-arm randomized placebo-controlled post-only intervention     trial in wood stove homes with children less than five years old. Education on best-burn     practices and training on the use of simple instruments (i.e., stove thermometers and wood     moisture meters) will be introduced as one intervention arm (Tx1). This intervention will be     evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3,     sham air filters). The primary outcome will be LRTI incidence among children under five years     of age. To allow for detection of exposure and outcome differences within each of the three     regions, a sample of 324 homes, or 108 within each study area will be equally assigned to     each of the three intervention arms. The overall hypothesis is that a low-cost, educational     intervention targeting indoor wood smoke PM2.5 exposures will be sustainable, and can reduce     children's risk of LRTI in underserved Native and rural communities.   "
79898|NCT02240121|"     The primary objective is to determine the efficacy of rifaximin DR tablets vs. placebo for     the induction of clinical remission and endoscopic response following 16 weeks of treatment     in subjects presenting with active moderate Crohn's disease. A key secondary objective is to     evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.   "
79899|NCT02240108|"     The primary objective is to determine the efficacy of rifaximin DR tablets vs. placebo for     the induction of clinical remission and endoscopic response following 16 weeks of treatment     in subjects presenting with active moderate Crohn's disease. A key secondary objective is to     evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.   "
79900|NCT02240095|"     Translation of new knowledge from research into evidence-informed health care is a shared     obligation of the clinical and the scientific communities. Unfortunately, studies of quality     of care continue to show that this goal is substantially unrealized. One main barrier is lack     of quick and easy identification, appraisal and synthesis of current best evidence. This     start with medical and nursing students, which have numerous clinical-related questions     daily, but face a large volume of 3000 articles published every day, accessible in many     scattered resources.      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,     Canada) has developed and implemented McMaster Premium LiteratUre Service Federated Search     (MPFS), an online search engine that provides a unique 1-stop search and organized access to     current best evidence in daily practice. However additional barriers need to be overcome for     students to actually search and use this evidence in their learning and practice. Theses     include logistical barriers (time constraints, forgotten questions), as well as educational     barriers (eg, lack of awareness of the architecture of evidence, limited searching skills,     and lack of reference standards among peers for finding best evidence).      In a previous trial, the investigators tested 3 innovative online interventions among     clinicians registered to MPFS to overcome these barriers and increase the quantity and     quality of searching for current best evidence to answer clinical questions (NCT02038439).     The investigators seek to conduct a second randomized trial testing the same 3 interventions,     this time among medical and nursing students registered in MPFS.   "
79901|NCT02240082|"     This study is a clinical trial in which 300 Police Officers who currently work midnight     shifts in the participating police departments will be recruited to test the effectiveness of     a new web-based program to address sleep and associated problems related to shift work,     particularly night shift work. Recruitment letters will be sent to all officers currently     working midnight shift, with the goal of recruiting 300 officers willing to participate in     the study. The 300 participants will be randomly assigned to either the experimental group     (receiving the web-based program) or the waitlist control group. Participants in the     experimental group will be given access to the program site (COPing with Shift Work) and the     mobile application (Sleep Tracker). Following completion of the field test, participants in     the control condition (as well as all other interested officers) will have access to the     web-based COPing with Shift Work program.      All participants will be asked to complete a baseline questionnaire containing multiple     measures of sleep, dietary practices, physical activity and job performance. Participants     will be asked to complete the posttest approximately three months following initial access to     the intervention.      Primary and secondary outcome measures: The Primary outcome measures are sleep quality as     measured by the Pittsburgh Sleep Quality Index (PSQI) and sleepiness as measured by the     sleepiness subscale of the widely used Karolinska Sleep Questionnaire (KSQ). The     investigators have adapted the sleep measures to apply to individuals who work nights and may     sleep during the day.      Secondary outcome measures include the Nutritional Patterns Scale, a 13-item modification of     the Block Self-Administered Diet History Questionnaire assessing the nutritional value of the     respondent's diet; Attitudes Toward a Healthy Diet, a 17-item scale, based on the Health     Belief Model and developed and validated by Trenkner and associates assessing perceived     benefits and barriers to eating a healthy diet; the Godin Leisure-Time Exercise     Questionnaire, a brief 4-item query of usual leisure-time exercise habits; and work     productivity measured with the Work Limitations Questionnaire (WLQ), developed and validated     by Lerner and associates.      It is expected that the program group participants will have significantly better outcomes     than the control group at three months.   "
79902|NCT02240069|"     A critical need exists for efficient community-based interventions aimed at reduction of     environmental exposures relevant to health. Biomass smoke exposures due to residential wood     heating are common among rural Native American communities, and such exposures have been     associated with respiratory disease in susceptible populations. In many of these communities     wood stoves are the most economic and traditionally preferred method of residential heating,     but resource scarcity can result in burning of improper wood fuels and corresponding high     levels of indoor particulate matter. Community-based participatory research techniques will     be used to adapt intervention approaches to meet the cultural context of each participating     community. At the community level, investigators will facilitate local development of a     tribal agency-led wood bank program ensuring that elderly and/or persons with need have     access to dry wood for heating. At the household level, investigators will use a three arm     randomized placebo-controlled intervention trial to implement and assess education/outreach     on best burn practices (Tx1). The content and delivery strategies of the education     intervention will be adapted to each community according to stakeholder input. This     educational intervention will be evaluated against an indoor air filtration unit arm (Tx2),     as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the     other two treatment arms to evaluate the penetration and efficacy of the community-level wood     bank program. Outcomes will be evaluated with respect to changes in pulmonary function     measures and respiratory symptoms and conditions among household elders. The investigators     hypothesize that locally-designed education-based interventions at the community and     household levels will result in efficacious and sustainable strategies for reducing personal     exposures to indoor particulate matter, and lead to respiratory health improvements in     elderly Native populations. This study will advance knowledge of cost-effective environmental     interventions within two unique Native American communities, and inform sustainable     multi-level strategies in similar communities throughout the US to improve respiratory health     among at-risk populations.   "
79904|NCT02240043|"     The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone     (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon     stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some     parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with     secretion of GH.   "
79906|NCT02240017|"     This is a phase II/III, multicenter, randomized study which includes 420 patients on six     years + 3 years follow up. 92 patients will be included during the phase II ; additional 328     patients will be included.      Patients with an advanced or metastatic urothelial cancer with impaired renal function will     be randomized in one of the two following chemotherapy arm:        -  Fractionated Cisplatin + Gemcitabine.        -  Carboplatin + Gemcitabine.      The main objective of the part II study will be to evaluate the efficacy and the safety of a     chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or     Carboplatin in this population.      The main objective of the part III study will be to compare the efficacy in terms of overall     survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated     Cisplatin or Carboplatin in this population.   "
79907|NCT02240004|"     The aim of this study is to compare purification efficiency of HFR in terms of clearance of     protein-bound toxins and the effects on markers of inflammation and endothelial damage, in     comparison to HF-HD and OL-HDF.   "
79908|NCT02239991|"     A point-of-care bleeding management protocol based on global viscoelastic test     (thromboelastometry) can change the amount of blood products used during orthotopic liver     transplant.   "
79924|NCT02239770|"     The objective of this study is to test the effect of a range of doses of a novel nicotine     film on plasma nicotine levels, expired carbon monoxide and, via a questionnaire, subjective     ratings of the film and side effects. The nicotine film is not part of standard of care and     is not available in a non-investigational setting. The investigators hypothesize that plasma     nicotine levels will be in keeping with those induced by other oral nicotine replacement     therapies (NRTs) and by the smoking of a cigarette. Thus, the investigators predict that     random delivery of nicotine via the oral film will be safe and well-tolerated by the human     subjects.   "
80076|NCT02237755|"     Coadministration of various drugs used for ovarian stimulation can increase the efficiency of     IVF especially in poor responders. The investigators hypothesize that ovarian response of     those patients could improve by using combination of clomiphene citrate with gonadotropins in     infertile women with poor response to gonadotrophin administration only.   "
79909|NCT02239978|"     The primary goal of this project is to gain a better understanding of whether and how     levodopa (a common anti-Parkinson disease medication) alters postural motor learning in     people with Parkinson disease. A secondary goal is to assess whether motor cortical     excitability, measured via Transcranial magnetic stimulation, is related to postural motor     learning.      Participants with Parkinson disease will complete between 50 and 100 postural perturbations     (via support surface translations), ON and OFF their dopamine replacement therapy (i.e.     levodopa). Adaptation of responses to these perturbations will be tracked. Participants will     also undergo transcranial magnetic stimulation to capture cortical excitability of the brain     (in particular the motor cortex). Cortical excitability will be correlated to adaptation of     stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture     postural motor learning and cortical excitability in age-matched healthy adults.      Investigators hypothesize that dopamine will have a negative effect on postural motor     learning, and the cortical excitability will be correlated to postural motor learning.   "
79910|NCT02239965|"     Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications     and patient discomfort. However, monitoring is not applied consistently by Danish anaesthesia     personnel. Surveys show that part of the explanation is that the anaesthetists often     experience problems with the equipment used for monitoring, though the problems have not been     described in detail.      We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by     insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in     interpreting the measurement results.   "
79911|NCT02239952|"     The purpose of this study is to determine intratumoral concentration of kinase inhibitors     upon 2 weeks of treatment in tumor tissue (in the brain) of patients with high-grade gliomas     (HGG).   "
79912|NCT02239939|"     The purpose of this research study is to see whether wearing a weighted vest during a period     of active weight loss can decrease the loss of muscle and bone that occurs during weight     loss. We will also determine if study participants who wear the weighted vest will have     greater improvements in physical function and self-reported disability, pain, stiffness,     fatigue and quality of life. This knowledge could impact weight loss programs designed for     older adults.      Hypothesis: Participants randomized to VEST will experience similar weight loss, but less     loss of lean mass and bone density, than participants randomized to Control.   "
79913|NCT02239926|"     Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?   "
79914|NCT02239913|"     This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®),     alone and in combination, on the reinforcing, subjective and physiological effects of     cocaine.   "
79915|NCT02239900|"     The goal of this clinical research study is to find the highest tolerable dose of ipilimumab     and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these     treatments given consecutively will also be studied.   "
79916|NCT02239887|"     Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage     Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular     atrial fibrillation in patients who are at increased risk for embolic stroke and have an     ongoing indication for oral anticoagulation.   "
79917|NCT02239874|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses. This ancillary study is being conducted among participants in VITAL and will     examine whether vitamin D effects mammographic breast density, mammographic texture features,     and gene expression profiles in breast biopsy tissue.   "
80007|NCT02238665|"     Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal     importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve     specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on     demand in vivo characterization of architectural and cellular details during endoscopy. Here,     we assessed the efficacy of CLE to differentiate between UC and CD.   "
79918|NCT02239861|"     PLEASE NOTE - THIS STUDY IS CURRENTLY ONLY RECRUITING PARTICIPANTS WITH RABDOMYOSARCOMA.      This is a clinical trial for patients with a solid tumor which has come back, or may come     back, or has not gone away after treatment, including the standard treatment we know for     these diseases. This is a study using special immune system cells called tumor-associated     antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.      The proteins that the investigators are targeting in this study are called tumor-associated     antigens (TAAs). These are cell proteins that are specific to the cancer cell, so they either     do not show or show up in low quantities on normal human cells. In this study, the     investigators target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a     different study, patients have been treated and so far this treatment has shown to be safe.      The investigators now want to try this treatment in patients with solid tumors.      This protocol is designed as a Phase I dose-escalation study.   "
79919|NCT02239835|"     Objectives of the study were to evaluate the efficacy and safety of two different doses of     tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI     combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two     different doses of TPV in combination with RTV for efficacy and safety.   "
79920|NCT02239822|"     Double Blinded Randomized Trial of eTNS as adjuvant treatment for Major Unipolar Depressive     Disorder. The primary objective is to assess the safety and tolerability of eTNS (external     trigeminal nerve stimulation) of the V1 branch of the trigeminal nerve as an adjunctive     treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).   "
79921|NCT02239809|"     Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive     Disorder. The primary objective is to assess the safety and tolerability of an implantable     sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients     with the diagnosis of unipolar MDD (Major Depressive Disorder).   "
79922|NCT02239796|"     To aim of this study is to establish the feasibility of undertaking a phase III trial of     transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate     stroke-related urinary incontinence.   "
79923|NCT02239783|"     Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety     and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These     types of studies are required by regulatory authorities for all THA devices that do not have     clinical evidence available at the time of gaining approval to market in the EU. This study     has been designed in accordance with MEDDEV 2.12/2 rev 2.   "
79925|NCT02239757|"     Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly     related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion     time has not been fully studied for SETMI patients undergoing primary percutaneous coronary     intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety     of left radial approach for primary PCI in STEMI patients compared with right radial     approach.   "
79926|NCT02239744|"     This study aimed to evaluate whether a short-term indoor air purifier intervention improves     cardiopulmonary health based on a randomized double-blind crossover trial   "
79927|NCT02239731|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104     Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving     Cetuximab or Panitumumab.   "
79928|NCT02239718|"     Tooth replacement is a significant issue in the World and while dental implants and     conventional bridges have been used to replace missing teeth, dental implants are too     expensive for many and conventional dental bridges are destructive to supporting tooth     tissue.      Resin-bonded bridges (RBBs) are a conservative and cost effective replacement option that     involves minimal tooth preparation, leaving the majority of the tooth intact. They are     secured in place with an adhesive cement, which is bonded to the outer enamel layer. Clinical     audit of these prostheses at the University of Hong Kong shows two-unit RBBs to have some of     the highest success rates in the dental literature for the replacement of missing premolar     and incisor teeth. However, for the replacement of molar teeth, two-unit RBBs are not     performed, as established protocol and recognised texts contraindicate their use due to     concerns with tipping or drifting of supporting teeth. Replacement of a single missing molar     tooth can be with a three-unit, fixed-fixed (single-piece casting) or three-unit,     fixed-movable (two-part casting). However, the fixed-fixed option has a higher debond failure     rate than two-unit RBBs and therefore, at this centre, a modified, 3-unit fixed-movable     design is used. This two-part casting allows for minor, independent movements of the     supporting teeth and thereby aims to reduce stresses between them and, similarly, reduce     de-bonding forces. This has the potential for greater longevity and easier long-term     maintenance as if the major part of the bridge debonds it can be recemented.      The aim of this unique study is to compare 2-unit and 3-unit RBBs for the replacement of     single missing molar tooth in a randomized clinical trial. These two designs will be     clinically evaluated at 6 months , 1 year, 2 years and 3 years to observe the outcome     measures. The primary outcome will examine the success of the dental prostheses with respects     to the need of any clinical intervention to repair or remediate the RBB or supporting tooth.     Minor outcome measures will examine fatigue or damage to the prosthesis, changes in bone     support, pulpal or periodontal health or tooth mobility. Patient satisfaction and quality of     life evaluation of the dental prostheses will also be examined. Will 2-unit RBBs offer     patients a simpler, cheaper, and successful option over current designs? This has not been     previously reported.   "
79929|NCT02239705|"     The purpose of this study is to investigate whether cardiac output (CO) and global end     diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are     mathematically coupled during the infusion of fluid or inotropic agents in critically ill     patients.   "
79930|NCT02239692|"     This was a phase 3, randomised, assessor‑blinded, multi‑centre trial comparing the efficacy,     safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day‑before     dosing schedule for colon cleansing in preparation for colonoscopy.   "
79931|NCT02239679|"     The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and     effective in the treatment of actinic keratoses on the face, following treatment with liquid     nitrogen cryotherapy.   "
79932|NCT02239666|"     To estimate the real-world effectiveness of approved biologics in subjects with     moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.   "
79933|NCT02239653|"     Objective: to test the hypothesis that an intervention comprised of targeted physician and     print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB)     and fruit juice they give to their children 1 - 12 years of age.   "
79934|NCT02239640|"     The purpose of this registry is to assess clinical outcomes, and different factors that may     affect these clinical outcomes such as systems of care, associated with the use of Covidien     market-released neurothrombectomy devices intended to restore blood flow in patients     experiencing acute ischemic stroke due to large intracranial vessel occlusion.   "
79935|NCT02239627|"     Low back pain is a common condition, affecting majority of the adults in the United States at     some point in their lives. Fortunately, most resolve, even without treatment. However, some     suffer from continued or recurrent pain.      For those suffering from continued or recurrent low back pain, numerous treatment options     exist. One such option is an epidural injection, particularly when other non-surgical     treatment options have failed. An epidural injection is the placement of a needle into the     space around the spinal cord with the aid of a live X-Ray machine, followed by an injection     of various medications. Typically, the medication that is injected is a steroid, commonly     with the combination of local anesthetic medication. Epidural steroid injections, with or     without local anesthetic is part of the established standard of care in the United States for     those with continued or recurrent low back pain. The steroid is believed to reduce     inflammation and edema of the injured or irritated nerves. However, despite the routine use     of epidural steroids, the steroid itself is not without risks or side effects. Though rare,     the steroids have been associated with complications including osteoporosis, steroid induced     myopathy, cataracts and many others. In order to minimize the side effects associated with     epidural steroids, limiting the dose and frequency have been outlined.      Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and     Drug Administration approved the medication for epidural use for cancer pain but studies have     shown effectiveness in non-cancer pain was well and is routinely used for various conditions.     There is growing evidence on the use of epidural clonidine for treatment of pain, including     low back pain.      This research will study and compare the effectiveness, if any, of clonidine compared to     steroid in an epidural injection for low back pain.   "
79936|NCT02239614|"     The potential synergistic effect of administering 2 dengue vaccine candidates that were     previously shown to be safe and immunogenic in humans will be evaluated in this study. A     prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with     alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17)     will gather data to help better understand the human immune response to dengue vaccination     and infection.   "
79937|NCT02239601|"     The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. A theory is     that the microtubule-stabilizing agents that prevent division of cells also affect healthy     peripheral nerves. Symptoms of CIPN are in the hands/feet and include: pain, numbness, and     loss of function. An estimated 55-60% of patients will experience lasting symptoms affecting     function for years post-treatment. Research on nerve disorders identifies that a nerve     already entrapped/damaged at one site may be at greater risk when combined with chemotherapy     (double crush syndrome). Physical therapy is an established, effective treatment for     entrapped nerves and neuropathic pain. This study seeks to identify additional risk factors     and provide evidence for the role of physical therapy in the treatment of CIPN.      Hypotheses        1. Physical therapy will assist in managing symptoms (sensory, pain, edema) compared to the          control group during chemotherapy.        2. Positive tests for mechanical entrapment prior to chemotherapy will result in more          severe symptoms of CIPN.        3. The treatment group will have greater resolution of CIPN symptoms compared to control at          the six month follow-up.   "
80077|NCT02237742|"     To determine how the body reacts to a low dose of PF‑06427878 when given in a vein over 30     minutes to healthy, adult, males.   "
79938|NCT02239588|"     This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with     a 12-week intervention period.      The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6     months) milk powder on:        1. Bone health;        2. Infants growth;        3. Intestinal health;        4. Gastrointestinal tolerance to the test product;      g) Incidence of Eczema   "
79939|NCT02239575|"     This study will enroll specimens from subjects diagnosed with various cancers and who have     either:        1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor          and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within          the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks          no longer required to be maintained on file - discard blocks, or        2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to          scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After          surgery, surplus tissues (including tumor and adjacent normal tissues) not required for          diagnosis will be collected.      Subject clinical information will be collected, including basic demographic information,     medical history, current cancer history and treatment. A final pathology report will be     obtained for each subject's surgical specimen. In some instances, and based on the cancer     indications required, longitudinal data may also be collected at a frequency of every 6     months to once per year. Longitudinal data will include information on study subject survival     and disease recurrence.   "
79940|NCT02239562|"     The purpose of this study is to study the safety and tolerability of synthetic     PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune     hepatitis is a disease where the patient's immune system produces an inappropriate immune     response against their own liver. PreImplantation Factor is a substance that is secreted by     viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing     the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous     properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in     preclinical models of autoimmunity and transplantation (published). Specifically sPIF     protected the liver against immune attack. In FDA mandated toxicity studies (mice, dogs),     high-dose sPIF administration for 2 weeks followed by 2 weeks observation period demonstrated     a high safety profile. Based on those observations the FDA has granted a Fast Track     designation for this trial. This study will evaluate the safety, tolerability and the blood     level of this synthetic version of this natural compound in the circulation.   "
79941|NCT02239549|"     The purpose of this study is to evaluate and compare the incomplete resection rates for small     colon polyps less than or equal to 6 mm in size using two conventional polypectomy tools,     jumbo cold biopsy forceps and cold snare.   "
79942|NCT02239536|"     The complete removal of colorectal polyp is required to prevent tumor recurrence and     development of potential interval cancers. However, several studies have shown high     incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5     mm. The polypectomy techniques using hot snare are usually used for the removal of these     polyps. However, the optimal technique for complete resection of these polyps is unknown.     There are few data comparing hot snare polypectomy with hot snare polypectomy after saline     injection for complete resection of colorectal polyps (5mm or larger). The aim of this study     is to compare hot snare polypectomy with hot snare polypectomy after saline injection for     removal of 5-10mm sized colorectal polyps.   "
80074|NCT02237781|"     Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable     levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF     about the effect of ovarian stimulation on the levels of AMH due to the increasing size of     follicles and chances of success of the method.   "
79943|NCT02239523|"     Patients who present with fragility fractures are consistently under-evaluated and     under-treated for underlying osteoporosis. This point of care represents a lost opportunity     to prevent future fractures. The medical field treats the fracture as if the fall is the     problem, but bone quality is the real problem. Studies have consistently shown that the     recommendations of the International Osteoporosis Foundation and World Health Organization     are not being followed. Orthopedics treats the patients for their fractures and primary care     physicians focus on general health but no one is taking responsibility for bone health.     Strategies to convince primary care to assume care have not succeeded. On the other hand,     strategies where orthopedics takes some responsibility have shown success. This prospective     2-arm study will evaluate the success of effort by an academic orthopedic department in     osteoporosis evaluation and treatment. We hypothesize that with greater effort by the     orthopedic department, the better the adherence to standards of care. A cost benefit analysis     will be made in parallel.   "
79944|NCT02239510|"     In this prospective, randomized, double blind study, the aim is to determine the efficacy of     Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation     (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna     or Linaclotide. Patients will be asked to complete questionnaires during the study and will     be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures     from surveys regarding bowel habits, relief, and satisfaction.   "
79945|NCT02239497|"     Proper management of acute postoperative pain (DAPO) is essential for the recovery of     orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its     effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the     effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under     general anesthesia. METHODS: A comparative study was conducted, randomized, two groups,     surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP     and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1:     200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with     ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia.     Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4   "
79946|NCT02239484|"     We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and     Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both     together in a 3 period repeatedly.   "
79957|NCT02239328|"     This survey study is looking to determine if patient reported outcomes(using the PROMIS     survey) will vary according to the presence of recurrent or metastatic lung or esophageal     cancer.   "
80078|NCT02237729|"     This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm,     single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and     EU administered subcutaneously (SC) to healthy male and female volunteers   "
79947|NCT02239458|"     Cystic fibrosis related diabetes (CFRD) is a common co-morbidity in patients with CF. The     underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of     investigation. In addition to localized tissue damage developing similar to that of the     exocrine pancreas, other mechanisms may be involved. We have shown that a potential     contributing factor to the patho-physiology of CFRD may be an abnormal gut derived hormonal     profile, specifically of lower incretin hormone responses, prior to development of CFRD.      We propose that an altered incretin response, probably due to impaired interaction of     nutrients with the gut mucosa due to thickened secretions, may play a role in the development     of the disease. Specifically, low GIP and GLP-1, may explain the poor β-cell function     observed in these patients prior to CFRD appearance. These incretins have known trophic     effects on β-cells, and thus their lower levels may contribute to the development of     quantitative as well as qualitative defects in β-cell function and thus may lead to the     development of CFRD. Thus, increasing levels of these incretins using a DPP-IV inhibitor may     improve glucose metabolism and delay/prevent the development of CFRD.      We hypothesize that Saxagliptin will increase the oDI compared to placebo and will thus     provide relative protection from diabetes development and in addition we expect that     Saxagliptin will lead to overall increased insulin concentrations and thus shift the     metabolic milieu to a more anabolic state. This will manifest as weight gain and reduction in     inflammation.   "
79948|NCT02239445|"     The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine     is as effective as second dose of oral chloral hydrate for rescue sedation in infant age     between 1 and 6 months who were not adequately sedated following initial dose of chloral     hydrate.   "
79949|NCT02239432|"     Early adenocarcinoma of the lung has an excellent five-year survival after resection.     However, its clinical and radiologic presentation is highly variable. Traditional means for     preoperative diagnosis such as Positron Emission Tomography (PET-CT) and trans-thoracic     needle biopsy demonstrate unacceptable false positive and negative rates.      Telomere biology is activated aberrantly is most lung cancers but has not been studied in     early stages to the best of our knowledge.      The objective of this study is to evaluate telomere length and activity with suspected early     stage adenocarcinoma of the lung.   "
79950|NCT02239419|"     Foot ulceration usually precedes more serious foot complications such as infection, gangrene     or amputation. The risk of developing foot ulcers has been estimated to be higher in     individuals with kidney disease. Patients with kidney disease receiving dialysis have an     increased prevalence of critical limb ischemia. Carbon dioxide (CO2) foot bathing has been     reported to improve subcutaneous microcirculation. The proposed clinical study will evaluate     the therapeutic potential of CO2 enriched water (produced by the Carbothera device) on     treating foot ulcers in patients with critical limb ischemia and undergoing hemodialysis.     Forty individuals how have a distal extremity ulcer who are currently undergoing hemodialysis     will participate in this study.   "
79951|NCT02239406|"     The purpose of this study is to determine if avascular necrosis of the acetabulum is present     in metal-on-metal revisions and to what depth this dead avascular bone occurs.      A convenient sample of a consecutive series of 15 patients treated for metal on metal     acetabular revision surgery will be included.   "
82122|NCT02211053|"     The purpose of this study is to evaluate if the administration of an infusion of     levothyroxine can improve heart function in organ donors   "
79952|NCT02239393|"     The mechanism of action of MSC relies on their ability to modulate pathogenic immune     responses and provide neuroprotection through the release of anti-apoptotic, anti-oxidant and     trophic factors as demonstrated by in-vitro and in-vivo preclinical studies.      Patients will be randomized to receive immediate vs. delayed treatment with either a dose     equal to 1-2 millions/kg of body weight of autologous MSC, or equivalent volume of suspension     media at baseline. At week 24 treatments will be reversed.      The primary outcome of this study is to evaluate:        -  Treatment's safety within one year from MSC administration by measuring the number,          time-frame and severity of adverse events and        -  Treatment's activity in terms of reduction in total number of gadolinium-enhancing          lesions (GEL) by magnetic resonance imaging (MRI) scans.      Secondary outcomes are to gain preliminary information on the efficacy of the experimental     treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and     disability progression).   "
79953|NCT02239380|"     The purpose of this study is to determine the efficacy, safety and pharmacokinetics of     Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.   "
79954|NCT02239367|"     The goal of this proposed pilot study is to test the feasibility and acceptability of a     Depression Decision Aid (DDA) protocol integrated into the Electronic Health Record (EHR) and     used by nurses with depressed ambulatory care patients. The Depression Decision Aid protocol     is a streamlined adaptation of an in-person Shared Decision-Making (SDM) intervention, and     its goal is to increase patient involvement in clinically appropriate treatment     decision-making as a way of strengthening treatment engagement and outcomes. The protocol     guides ambulatory care nurses in helping depressed patients (Patient Health Questionnaire-9     [PHQ-9] >10) develop informed treatment preferences through a process of education and values     clarification. We will target patients in the general medical clinic, whether currently     receiving depression treatment or not, because depression is highly prevalent but often     poorly managed in this population.   "
79955|NCT02239354|"     The purpose of this trial is to test if VC-01™ combination product can be implanted     subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will     also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.   "
79956|NCT02239341|"     The current standard of care for pregnant women deemed to be high-risk often involves     recommending varying levels of activity-restriction, up to and including hospitalization.     High levels of activity-restriction can lead to physical deconditioning of the mother, which     can be difficult to recover from after birth. The proposed study will investigate whether a     mild muscular conditioning program conducted in bed and given to hospitalized     activity-restricted high-risk pregnant women will improve functional ability, cardiovascular     deconditioning and overall quality of life in the postpartum period compared to a control     group with no in hospital bed-rest exercise program. We hypothesize that women with a     in-hospital muscle conditioning program will be better able to perform functional ability     tasks and activities of daily living than a control group with no exercise program.   "
79958|NCT02239315|"     The purpose of this study is to find out if the pathological complete response (pCR) to     chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the     evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA     score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third     cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant     chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast     cancer management.   "
79959|NCT02239302|"     Obstructed defaecation syndrome is a common problem in which patients experience difficulty     to evacuate stools and feel that the bowel is incompletely empty, which causes the need to     put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a     significant effect on social, physical, emotional and sexual wellbeing all of which have     impact on quality of life. These symptoms are caused by posterior compartment disorders such     as the last part of the large bowel bulging into the vagina (rectocele), the small bowel     pressing on the rectum (enterocele), a circumferential infolding of the rectal wall     (intussusception) or paradoxical pelvic floor contraction during attempts to evacuate     (anismus).      Currently the evacuation proctogram is the gold standard for diagnosis of posterior     compartment disorders. This technique, however, exposes the patient to ionising radiation,     requires preparation of the small and large bowel with contrast and defaecation in a     non-private setting, which most women find embarrassing and unpleasant. Over the years,     research has focussed on identifying alternatives that are better tolerated to substitute     evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast     and a well-tolerated method for the dynamic and static imaging of the pelvic floor without     the use of ionising radiation. The level of agreement between transperineal ultrasound (TPUS)     and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to     proctography. The aim of this study is to assess the level of agreement between ultrasound     (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment     disorders.   "
79960|NCT02239289|"     The purpose of the present study is to evaluate the benefit of biofeedback training on the     capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles     activity during trunk full flexion and its relationship with changes in clinical outcomes. To     do so, twenty patients with nonspecific mechanical low back pain will be recruited and all     participants will take part in four sessions of supervised biofeedback training, consisting     of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that     participants will have improved neuromechanical parameters with the biofeedback training and     that this improvement will be positively associated to changes in clinical outcomes. This     study will also allow for generation of preliminary data, in order to plan for a larger     randomized control trial.   "
79961|NCT02239276|"     This is an expanded access use of Stiripentol in Dravet Syndrome or epileptic     encephalopathies associated with sodium channel mutations who have failed other drugs in an     effort to give them the best chance at seizure control and quality of life. As a treatment     protocol and not a research study, children will only be monitored on a clinical basis for     seizure improvement and side effects predominantly by parent and caregiver report.   "
83304|NCT02195622|"     To compare efficiency, in terms of tissue morcellation and removal time, of two commercially     available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing     HoLEP procedure for benign prostatic hyperplasia (BPH).   "
79962|NCT02239250|"     DelAgua Health Rwanda (Implementation) Ltd. together with Rwanda Ministry of Health (MoH) are     delivering an intervention, consisting on the free distribution of one advance water filter     and one improved cookstove to all household classified as ubudehe 1 and 2 according to     government approved registers (poorest tertile), in Western Province. The aim of this     intervention is to reduce the morbidity and mortality associated with diarrhoeal diseases and     pneumonia in Rwanda.      The London School of Hygiene and Tropical Medicine (LSHTM) will be undertaking an independent     evaluation of this large-scale intervention to assess its impact on health. The trial will     evaluate whether the provision of improved cookstoves and advance water filters can reduce     pneumonia and diarrhoea disease in children under 5 years of age.      A cluster randomized controlled trial (CRCT) with two arms of unequal size (3:1 ratio) will     be use to answer this question. The 96 sectors in Western Province, Rwanda, will be     randomised to either receive the intervention or the control. Each eligible household in     intervention sectors will receive one EcoZoom™ Spartan and one Vestergaard Frandsen Lifestraw     Family™ 2.1 water filter free of charge. Eligible households in control sectors will continue     with their traditional cooking and drinking practices. Health data on children under 5 years     of age will be collected from community health worker (CHW) and health facility records all     across Western Province to evaluate the health impact of the intervention. The study will     encompass 12 months of follow-up. After this time the control sectors will receive the     intervention.      This independent evaluation will also include a nested village-level study within the larger     sector-level study, with the aim to evaluate uptake, consistent use and acceptability of the     intervention, as well as to assess the impact on environmental exposures and health outcomes.     174 villages (74 controls and 74 intervention) will be selected for participation. Household     surveys will be used to collect data on intervention use and acceptability as well as on     self-reported health data. Water samples will be collected and monitoring of exposure to     Households Air Pollution (HAP) will be undertaken. Measurements of blood pressure, expirated     Carbon monoxide (CO) and pulse CO-oximetry will be undertake in primary cooks and or children     under 5 years of age. Additionally, as part of this nested study, two exploratory studies     will also be conducted. One will be focused on assessing the potential of biomarkers as     indicators of environmental exposures (mainly HAP and water quality) and health status, while     the other exploratory sub-study will assess the reactivity of participants to the use of     remotely reporting electronic sensors to measure target behaviours.   "
79963|NCT02239237|"     This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the     potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind     of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and     Rhizoma Heterosmilacis Japonicae.   "
79964|NCT02239224|"     The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the     treatment of adult patients with molecularly defined genetic muscular dystrophies   "
79965|NCT02239211|"     This is a phase II study to determine the safety and preliminary efficacy of a human     monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use     in the treatment of patients with primary sclerosing cholangitis (PSC).   "
79977|NCT02239055|"     Despite expert opinion unconvinced of any value for hospitalization in caring for people with     borderline personality disorder (BPD), this patient group still accounts for a significant     proportion of adult acute mental health (AMH) admissions. Staff nurses generally voice     negative perceptions of BPD, a view which is linked to an uncertainty of how to approach     these patients, and difficulties leading to personal distress and burnout.     Mentalization-based treatment (MBT) is an evidence based approach, focusing on the mental     states of both self and others, developed specifically to treat BPD and facilitated     successfully in specialised settings. MBT Skills training is a compact and cost effective two     day workshop which equips generalist mental health nurses with a skillset enabling them to     work effectively with BPD. MBT Skills training was first offered to staff nurses in Royal     Cornhill Hospital, Aberdeen in 2013. This study aims to assess staff perceptions on the value     of MBT skills training, evaluating how it impacts on clinical practice when working with BPD     in AMH.   "
79966|NCT02239198|"     There are prevalent micronutrient and fiber deficiencies in a significant proportion of US     population, particularly among the overweight or obese. Intensive lifestyle counseling     results in modest, measurable dietary improvements and weight stabilization, yet falls short     of restoring optimal nutritional status and metabolism. A carefully formulated nutritional     supplement bar (referred to as the CHORIBAR) delivered in a whole food matrix may correct     micronutrient deficiencies in overweight or obese adults and children. This may have a     beneficial impact on traditional indices of insulin dysregulation and the metabolic syndrome,     gut inflammation, redox status, immune function and DNA integrity, and may favorably     influence weight change and fat distribution.      The investigators believe that the improvements seen with CHORIBAR trials will be mediated at     the level of generalized enhancement in cellular metabolism that are not readily achieved     with lifestyle counseling alone. The investigators suspect this is due to many nutritional     barriers, some of which are disproportionately borne by inner city populations, such as cost     and access to healthy food. The investigators hypothesize that a nutritional supplement like     the CHORIBAR will facilitate restoration of optimal nutritional status and improve metabolic     and weight outcomes.   "
79967|NCT02239185|"     Aim of the study The aim of this study is to test the hypothesis that during laparoscopic     hernia repair, disconnection of the hernial sac along with suture ligation of the neck is     better than transperitoneal purse string suture around the hernial sac at the neck leaving     the sac in continuity. Also to compare the two different laparoscopic techniques as regards     operative time, recurrence rate, hydrocele formation, and other possible complications as     bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic     results.   "
79968|NCT02239172|"     The purposes of this study is to evaluate and compare the safety, reactogenicity, and     tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel   "
79969|NCT02239159|"     The investigators assume that transcutaneous electric acupoint stimulation (TEAS)     pretreatment may activate the endogenous protective mechanism, as a result protect the     patients against subsequent surgical stress pregnancy. And TEAS may induce the production of     endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators     believe this intervention will reduce the subsequent incidence, duration and severity of     organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the     investigators hypothesize that TEAS before anesthesia and during surgery would decrease the     morbidity and mortality of postoperative complications in 30 days after digestive surgery in     elderly patients .   "
79970|NCT02239146|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor     XIII, catridecacog) administered following first time myocardial revascularization requiring     cardiopulmonary bypass (CPB).   "
80071|NCT02237820|"     This is the first study assessing the impact of dexamethasone (a glucocorticosteroid with     negligible mineralocorticoid activity) as compared to prednisone on short-term outcomes of HF     patients hospitalized with exacerbation of COPD. The study may provide important data     regarding a simple but potentially robust intervention among large patient population with     high rates of hospital admissions.   "
79971|NCT02239133|"     The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and     Termination.      Subject screening will be held during visit one (1) and visit two (2) at the clinic.      Initiation and Size fitting:      All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during     visit 2, to find the suitable size for her. The subject will use the ProVATE device of the     chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home     environment, to confirm that the chosen size is appropriate for the user. Each usage will be     followed by a vaginal examination. In case the investigator will determine that the subject     should be fitted with a different size of the ProVATE device the subject will repeat this     stage with a different device size until the suitable size is confirmed by the investigator.      Usage:      The subject will use the ProVATE device for at least 28 days during a 45 days period, at her     home environment, and fill a usage diary. Each device will be used for at least 24 hours. At     least one (1) follow-up phone call will be held with the subject per a week. After 14 usage     days or following at least two (2) usages (the latest of them) the subject will be scheduled     for vaginal examination at the clinic (visit four (4)).      End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a     vaginal examination and additional activities.      The following questionnaires will be filled at baseline and end of study: Quality Of Life     (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end     of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.   "
79972|NCT02239120|"     This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown     source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1     ratio) and have visits every three months. The study doctor may prescribe blinded concomitant     ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs),     Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when     the required number of stroke events are positively adjudicated which is estimated to take 3     years (including 2.5 years of enrollment).   "
79973|NCT02239107|"     Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive     aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene     citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second     line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction.     Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy,     some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has     emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and     pregnancy rate.   "
79974|NCT02239094|"     We propose to conduct a pilot study of biological predictors of lurasidone response in     bipolar depression.   "
79975|NCT02239081|"     This is a Phase 1, single center, single-ascending dose, randomized study   "
79976|NCT02239068|"     Hypothesis: The investigators hypothesize that more than 50% of the patients receiving     enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric     fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by     using region of interest in the CT technique is accurate compared to blind aspiration of the     gastric contents with a syringe and a multi-orificed orogastric tube.   "
79978|NCT02239042|"     The aim of the present study was to evaluate the influence of LLLT on the recovery of the     palatine donor site wounds after harvest connective tissue graft.   "
79979|NCT02239029|"     Although few studies have showed beneficial effect of platelet rich plasma (PRP) for     osteoarthritis of knee (OA knee), only one study applied randomized, control method and none     of them has the objective measurements such as balance test or muscle strength which were     reported as decrease in patients with OA knees. We assess the analgesic effect and the extent     of improved muscle strength and balance after PRP in patients with OA knee.   "
79980|NCT02239016|"     This study aims to study the temporal course of sickle nephropathy and assess novel     biomarkers that can predict patients prone to nephropathy.   "
79981|NCT02239003|"     NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were     found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This     study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be     allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d);     (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may     yield better efficacy than placebo for cognitive function in patients with mild cognitive     impairment.   "
79982|NCT02238990|"     The following trial is a multicenter and prospective research trial of the colposcopy unit of     luebeck university and the national research center in Borstel, Germany.      The study is to identify and evaluate new biomarkers in human papilloma virus (HPV)     associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples     being removed during conizations and/or hysterectomies are to be fixed in HOPE`s solution and     analyzed according to their transcriptomes and methylosome. The hereby found candidates are     to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain     reaction].      The project is meant to be followed by continuous studies developing a new test describing     the malignant potential of HPV associated genital lesions.   "
80008|NCT02238652|"     Improving quality of life (QoL) in residents of nursing homes:      A cluster randomized clinical trial of efficacy - The KOSMOS study.      COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and     treatment, Medication review, Occupational therapy, and Safety) is a practical intervention     aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention     combines the most effective research results to improve staff competence and patients' mental     health, safety, QoL. We also aim to reduce psychotropic drug use and costs.   "
80009|NCT02238639|"     The primary objective is to demonstrate the clinical benefits of an active strategy for the     diagnosis and treatment of PE compared to usual care in patients with unexplained     exacerbations of COPD who require hospital admission.      The secondary objective is to assess the safety of an active strategy for the diagnosis and     treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who     require hospital admission.   "
83305|NCT02195609|"     This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women     treated for 4 months with Omega-3 vs Soy Isoflavones.   "
79983|NCT02238977|"     The proposed study will evaluate the response and remission rates for major depressive     disorder (MDD) in end-stage renal disease (ESRD) patients undergoing maintenance hemodialysis     (HD) treated with bupropion or fluoxetine for 12 weeks. In addition, the study will document     the relative tolerability and safety, and longitudinally contrast the effects of bupropion     and fluoxetine on measures of cognitive function, fatigue, inflammation, and tryptophan (TRP)     and TRP catabolites in blood. It is hypothesized that both drugs will significantly reduce     MDD symptoms from baseline, and be tolerable and safe, but bupropion will be associated with     greater reduction in pro-inflammatory cytokines, cognitive impairment, and fatigue compared     with fluoxetine.      The Specific Aims of this study are:      Aim 1: Determine the efficacy of bupropion and fluoxetine in treatment of MDD in ESRD/HD     patients.      Aim 2: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and     fatigue differ between bupropion and fluoxetine.      Aim 3: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and     fatigue correlate with change in inflammation, measures of TRP availability to brain, or     neurotoxic TRP metabolites.      Hypotheses:        1. Bupropion and fluoxetine will both show efficacy in treating MDD;        2. Bupropion will lead to greater improvement in cognitive dysfunction and fatigue than          fluoxetine; and        3. Change in cognition and fatigue over time will correlate with change in c-reactive          protein (CRP) and quinolinic acid and change in overall depression score will correlate          with measures of TRP availability.   "
79984|NCT02238964|"     ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of     stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh     (Strattice®) is superior to the standard technique in preventing herniation at 2 years.   "
79985|NCT02238951|"     The purpose of this study is to compare nurse-led care coordination for persons receiving     cancer chemotherapy treatment incorporating mobile health technology to nurse-led care     coordination without any mobile health enhancements.   "
79986|NCT02238938|"     Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can     be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm,     resections are usually done in a hospital setting. For the resection of large adenomas,     different approaches can be used. The so-called piecemeal resection is done with snares, to     cut off parts of the adenoma piece by piece until the whole adenoma is resected. This     technique is the standard therapy, but is not required for very large adenomas, which can     often show cell alterations that indicate cancer. Therefore these adenomas should be resected     in one piece. This is done by the so-called en-bloc resection. For this kind of therapy,     different endoscopic knifes are use to cut off the adenoma as a whole. Both resection     techniques are done usually by previous injection of saline or other liquids to elevate the     lesion from its bottom tissue.      Although the piecemeal resection of large adenoma is the standard therapy, it shows     recurrence rates of 10 to 25%, which afford repeated therapies and follow up controls.     En-bloc resections, though, are expected to have less recurrence rates but are much more     complex to perform. They have higher complication rates especially in the West, where it has     bee introduced only a couple of years ago.      The data situation regarding safety and efficacy of both therapies is low. This study is the     first one ever to compare piecemeal EMR and ESD in a randomized way. The study might have     influence on the logistics of future adenoma processing and patient flow.   "
79987|NCT02238925|"     The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization,     assess plasma drug levels, asses serum copper levels, and assess drug levels in urine.      Efficacy and Safety will be assessed in all patients enrolled to the study.   "
79988|NCT02238912|"     this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga     Rasayanam in Padarthamarai ( Ring worm infection )   "
79989|NCT02238899|"     The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All     german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in     the register. Object of the register is to maintain the quality of diagnostic standard by     using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).      Furthermore, the register should enable to continue the collection of epidemiologic data and     biological material (tumor material, CSF, and blood) for associated studies.   "
80000|NCT02238756|"     The purpose of this clinical trial is to investigate the safety and tolerability of IM     administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in     humans.   "
79990|NCT02238886|"     The purpose of this study is to determine whether a goal directed nutritional intervention     can reduce the convalescence period for patients undergoing radical cystectomy (RC).      The aim is to examine the effect on quality of life of a standard nutritional strategy of     resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery     versus a goal-directed nutritional intervention combining oral intake and parenteral     nutrition, in patients undergoing RC.   "
80006|NCT02238678|"     It has been demonstrated that ligaments, both cardinal and uterosacral contain a considerable     amount of autonomic nerve tissues. The resection of deep infiltrating endometriotic nodules     at the level of the uterosacral ligaments or the rectovaginal space is supposed to damage the     supplying autonomic nerve fibers of the lower urinary tract. The bladder receives motor and     sensitive innervations from both the sympathetic fibers, most of which arise from the     hypogastric plexuses and nerves, and the parasympathetic fibers, which arise from the pelvic     splanchnic nerves and the inferior hypogastric plexus; therefore, even bladder function may     be impaired in women affected by deep endometriosis.      Very few data have been published regarding the urodynamic functional evaluation of bladder     in patient with deep endometriosis.So far, it is unknown if the surgery itself causes the     postoperative bladder dysfunction or if the surgery unmasks a subclinically pre-existing     detrusor pathology.      Since the urinary postoperative complications have a strong impact on quality of life of the     deep endometriosis patients and often requires management (due to a poor spontaneous     remission), it is crucial a better understanding of the problem. That will help for a more     appropriate pre-operative counselling.      Aims of this study are to evaluate the bladder function before and after deep endometriosis     surgery, using standardized validated instruments and to correlate the localisation of the     endometriosis lesion, the type/area of surgical dissection with the postoperative bladder     function.      This is a prospective multicenter cohort study involving the Department of General     Gynaecology and Gynecological Oncology of Medical University of Vienna (Austria) and the     Department of Obstetrics and Gynaecology of Insubria University, Varese (Italy).      A total of 50 patients are planned to be included. The study protocol consider a Preoperative     Assessment (clinical examination, transvaginal pelvic ultrasound, preoperative specific     questionnaire including obstetric, medical, and surgical history and standardized questions     on pelvic floor dysfunctions, standardized instrumental assessment of the pelvic floor) a     Intraoperative Assessment (during laparoscopy, the localizations of endometriotic lesions     recorded and identified by anatomical sites, numbers, and depth of infiltration). Before and     3 months after surgery a Urodynamic assessment is planned.   "
79991|NCT02238873|"     Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells,     specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to     decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer     types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim.     Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection     in patients undergoing chemotherapy. It has a much longer half-life than the parent     filgrastim. It is removed from the body within the neutrophils. According to the American     Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the     completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is     cleared before and after neutropenia. Comparative low quality studies suggest that deferring     pegfilgrastim delivery until neutrophil counts start dropping may result in improved its     efficacy. This was further tested in a few small randomized controlled trials (high quality     studies, considered the gold standard of studies) in different settings (including first     chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given     24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for     patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized     controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours     (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed     aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim     schedule affects the risk of fever during neutropenia, neutrophil count, length of     hospitalization, mortality, and safety.   "
79992|NCT02238860|"     Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents     have been claimed equivalent in treatment, there are no head to head trials available in the     literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed     to compare safety/efficacy and virological response in patients with HBV Decompensated     Cirrhosis.   "
79993|NCT02238847|"     The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to     Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary     obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.   "
79994|NCT02238834|"     This is a randomized, placebo controlled, single and multiple ascending dose study to assess     the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.   "
79995|NCT02238821|"     The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models,     featuring association of carcinogenesis with a blood procoagulant disorder. MET is frequently     overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE) may occur in     association with poor prognosis, but the biological and genetic factors that cause VTE are     still obscure.      The Investigators propose to study whether in patients harboring a surgically resectable     colorectal cancer the MET oncogene is expressed and may be associated with a blood     thrombophilic condition that favors the onset of VTE.      These data would have two main implications: (i) for the first time, a direct genetic link     between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii)     the procoagulant alterations would have diagnostic/prognostic significance for the     identification of patients at risk for poor outcome, and implementation of appropriate     therapeutic protocols.   "
79996|NCT02238808|"     Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+     tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot.     Currently, there is no perfect way to tell these groups apart nor do the investigators know     why some respond when others do not.      Research findings suggest that the two types of ER+ breast cancers differ in their response     to estrogen with estrogen being toxic to one type and not the other. For those tumours that     find estrogen toxic, this may explain why tumours only start to grow when estrogen levels     decrease after menopause.      The purpose of this study is to see whether a two-week treatment of estrogen equal to     pre-menopausal estrogen levels will decrease the rate at which patients' ER+ tumours grow.     This will be done by comparing the growth rate in the tissue removed during standard of care     surgery after patients have been treated with 7-14 days of estrogen prior to that surgery.   "
79997|NCT02238795|"     Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is     characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF     is a manifestation of widespread clot formation in small blood vessels which emerges     secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is     dominated by symptoms of severe sepsis and multiple organ failure which are further     aggravated by the massive skin lesions.      At present, there are no evidence-based guidelines for the medical management of SAPF. With     numerous therapeutic approaches in use, there are no consistent comparisons of their     efficacy. Altered role of causal pathogens following the introduction of meningococcal and     pneumococcal prophylactic vaccines also remains to be investigated.      The goal of the registry is comprehensive collection and evaluation of information concerning     the epidemiology, morbidity, therapy and outcome of SAPF.   "
79998|NCT02238782|"     To assess the absolute bioavailability of oral selumetinib in healthy male volunteers   "
79999|NCT02238769|"     18F-FluoroethylCholine (18F-FECH) is a new tracer used in PET synthesized by Nuclear Medical     Center of Peking Union Medical College Hospital and is favored for diagnosis of primary brain     tumor. Although 18F-FECH showed a high presence of biological distribution in liver, 18F-FECH     PET may have a higher sensitivity in diagnosis of intra- and extra-hepatic lesions of HCC     respectively than those of 18F-FDG or 11C-acetate PET scan, and 18F-FECH PET could be a     promising tool in diagnosis and staging, therapy selection and prognostic evaluation for HCC     patients. However, much more cases are required to verify this theory. The purpose for this     study is to establish the model of clinical experimental prospective study, and to evaluate     the sensitivity, specificity and accuracy of 18F-FECH PET in diagnosis of HCC.   "
80005|NCT02238691|"     Continuous positive pressure during anesthetic induction is today not routinely used partly a     to the risk of gastric insufflation because of higher ventilatory pressures. However there     are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The     investigators aim to compare the risk of gastric insufflation regarding mask ventilation     technique, with or without positive end expiratory pressure. For measurements a High     Resolution Impedance Manometry Catheter is used.   "
80010|NCT02238626|"     This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed     to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60     mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS.      This study will consist of two treatment arms, MN-166 and matching placebo. Randomization     will occur in a 2:1 ratio (MN- 166: placebo).      Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months;     Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last     dose.      During treatment phase, subjects return to the clinic at Months 3 and 6 and will be     telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new     or concomitant medications.      All subjects (subjects who complete the Double-blind Phase and subjects who complete the     Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately     2 weeks after the last dose of study drug to assess adverse event status and to document     concomitant medications.      Safety will be assessed by monitoring and recording all treatment-emergent adverse events     (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. Additional     assessments will include regular monitoring of hematology, blood chemistry, and urine values,     regular measurement of vital signs, ECGs, medical history, physical and neurological     examinations.   "
80011|NCT02238613|"     The purpose of this study is to determine whether radioactive stents and common used plastic     stents are effective and safety in the treatment of unresectable biliary tract cancer.   "
80012|NCT02238587|"     To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity     status of the patients with head-and-neck cancer after complete treatment (including surgery     and / or radiotherapy and/or chemotherapy)   "
80013|NCT02238574|"     Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a     5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always preceded     by precursor lesions. Treatment of these premalignant mucosal abnormalities is generally     limited and not very inconvenient for the patient. If this precursor lesion remain untreated,     it may develop into a malignancy of the head and neck. Extensive treatment will be necessary.     This means loss of function of the mouth, eg chewing, speaking and swallowing.      The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ     hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying     the follow up and treatment in premalignant CIN lesions, the incidence of progression to     invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,     there will be a place for CIN detection as a risk indicator in the diagnostic work up of     premalignant lesions in the head and neck.      The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA     markers is a reliable indicator for progression to malignancy. By intensifying the outpatient     clinic follow up and treatment in premalignant lesions, the incidence of progression to     invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,     there will be a place for CIN and LOH detection as a risk indicator in the diagnostic work up     of premalignant lesions in the head and neck.   "
80014|NCT02238561|"     The investigators will examine the relationship between post-operative oxygen consumption     (using non-invasive measurement technology ) and complications in patients having     contemporary major abdominal surgery. The investigators hypothesis is that major surgery may     trigger a physiological stress response that results in an increase in post-operative     metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen     delivery (DO2).        1. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2)          using indirect calorimetry in a cohort of patients        2. To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the          same cohort using non-invasive measures of cardiac output, oxygen saturation and          haemoglobin (pulse wave transit time and co-oximetry techniques)   "
80015|NCT02238548|"     Rationale: Infections are an important worldwide cause of death, both in elderly and young     children. Therefore, support of immunity could help to reduce the incidence of infections. To     screen the potential of specific foods or food ingredients to support immunity, oral     vaccination can serve as a model. In this study, oral cholera vaccination will be applied in     human adult volunteers, and used as a model to study the support of the immune response by     raw milk.      Objective: To investigate whether raw milk is able to enhance the immune response as induced     by oral cholera vaccination.      Study design: The study is designed as a single-blind randomized controlled trial of 4 weeks.      Study population: Healthy subjects of 18-50 years of age.      Intervention: Raw milk, obtained from farms that comply to the high quality requirements for     production of raw milk, and that has been screened according to the safety criteria for raw     milk.   "
80016|NCT02238535|"     To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual     pulmonary hypertension.   "
80017|NCT02238522|"     The purpose of this study is to determine safety, tolerability, dose limiting toxicities     (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory     lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).   "
80018|NCT02238509|"     Recent clinical studies have shown that the combination of lapatinib and trastuzumab has     superior antitumor activity compared to either single drug in both neoadjuvant and metastatic     setting and is well tolerated. According to this evidence, the combination of lapatinib and     trastuzumab today offers a valid chemotherapy-free option, primarily for patients with     pre-treated HER2-positive MBC   "
80019|NCT02238496|"     The purpose of this study is to test the effectiveness of a drug called temsirolimus in     combination with a drug called perifosine in treating brain tumors that have continued to     grow after previous treatment. Temsirolimus is an intravenous drug approved by the FDA for     treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain     tumors. Perifosine is a pill that has not been approved by the FDA which blocks a messenger     that tells cancer cells to grow. Research suggests that combined treatment with both drugs is     better than either alone, and that it is reasonably safe.   "
80020|NCT02238483|"     The purpose of this study is to determine whether AZD7624 can reduce acute Chronic     Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy     with a history of frequent acute exacerbations   "
80022|NCT02238457|"     The sympathetic nervous system, a part of the nervous system that stimulates the heart via     release of substances, noradrenaline and adrenaline (combined called catecholamines), becomes     activated in people with heart failure. As these people become sicker, the nervous system     becomes more active, causing further damage to the heart.      Large trials have shown that Angiotensin-converting enzyme (ACE) inhibitors reduce morbidity     and mortality in patients with heart failure. Higher doses of these drugs are more effective     than lower doses. Studies show that ACE-inhibitors decrease catecholamine levels. This could     be why congestive heart failure (CHF) patients taking this class of drugs show improvement in     heart function.      There are several ways of measuring the activity of the sympathetic nervous system. The most     common measurement is to test the blood for catecholamine levels. This is not very reliable     or reproducible. Microneurography is a new technique used to measure sympathetic nerve     activity. A small electrode (comparable to an acupuncture needle) is placed in a muscle nerve     and hooked up to a stimulator and a recorder. It produces direct recordings of skeletal     muscle nerve traffic. Both the rate and amplitude of the burst can be measured. The results     in this technique are highly reproducible. By using this technique we get a more accurate     picture of how the nervous system responds to medications given to treat heart failure.      Losartan (Cozaar) is an angiotensin II type 1 (AT1) receptor blocker. It blocks the binding     of angiotensin II, a hormone that constricts blood vessels. As a result the blood vessels     remain relaxed, leading to a reduction in the workload of the heart. Minor decreases in blood     catecholamine levels have been reported with a low dose of this drug. The purpose of this     study is to see whether a high dose of losartan (200 mg) has a greater effect on the     sympathetic nervous system than a low dose of losartan (50 mg) does.      A total of 30 participants will be recruited. Participants will be assigned to one of two     groups: high-dose, in which subjects will receive treatment of 200 mg/day of losartan, and     low-dose, in which subjects will receive treatment of 50 mg/day of losartan. Via     microneurography the investigators will measure the difference in sympathetic activity in     subjects in high-dose vs low-dose losartan. The investigators expect to see further decrease     in sympathetic activity in high-dose group than in low-dose group.   "
80023|NCT02238444|"     The purpose of this study is to determine whether Warfarin Anticoagulation are effective and     safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients with Hypersplenism     after Laparoscopic Splenectomy.   "
80024|NCT02238431|"     Currently all patients that have freeze-all ICSI treatment cycles have the start of their FET     cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the patients     that have a blastocyst transfer has been maintained over time, 15% of started FET cycles are     being cancelled because of premature luteinization, and the treatment (to transfer) takes     approximately 89 days. The use of a Lucrin depot may reduce the number of cycles cancelled     and reduce the treatment time to approximately 69 days. The use of no drugs and allowing the     normal menstrual cycle to determine the time to start the FET cycle may suit some patients.     Whether these benefits can be obtained while still maintaining the current FET pregnancy rate     will be the main focus of the trial.   "
80053|NCT02238054|"     Observational Study, French, prospective, multicenter rated using intravascular prosthesis     ABSORB BVS.      ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all     procedures for coronary angioplasty with implantation of at least one BVS with a clinical     follow-up of all patients implanted with ABSORB BVS. This national observatory will collect     all the events related to product and / or to procedure   "
80054|NCT02238041|"     The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear     CGM System.   "
80055|NCT02238028|"     An intervention study to assess the short-term cardiovascular effects of reducing personal     air pollution exposure by wearing particulate filtering respirators.   "
80025|NCT02238418|"     Vitamin D is not seen anymore only as a phosphocalcic and bone hormone, but also as having an     effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and     cardiovascular protection).      Until recently, vitamin D repletion was defined as the minimal concentration that enables the     prevention of rickets in children and osteomalacia in adults, i.e, approximately 8 ng/mL (20     nmol/L). However, most of the international experts agree to set minimal threshold of 25 OH     vitamin D serum concentration, higher than the one previously admitted, with a limit of 20     ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to     define vitamin D insufficiency.      Recommendations for Vit D supplementation in healthy children were updated in France in 2012.     The invariable supplementation of infants and toddlers is efficient since deficiency-related     rickets have almost disappeared; however there is very few information in ill children     populations.      Vit D supplementation tolerance is usually considered as good and over-dosage risks are low,     however these studies were conducted more than 30 years ago, and as far as we know, there is     no study about calcium urinary excretion kinetics after intake of a 100 000 IU vial of     cholecalciferol (Uvedose®). When 25 OH vitamin D serum concentrations exceeds 200 ng/mL,     which is very rare in daily practice, toxic effects of Vit D may theoretically be observed,     particularly hypercalcemia and hypercalciuria.      Vitamin D deficit is very common in children with chronic kidney disease (CKD) with a 50 to     92% prevalence depending on the studies; it it is a risk factor for secondary     hyperparathyroidism.      Although international guidelines regarding the care of CKD children recommend 25 OH vitamin     D serum concentrations over 75 nmol/L, there are no practical recommendations in terms of     dose and frequency of native Vit D treatment.      Therefore, the objectives of the present study has are the following:        -  to validate prospectively the efficacy of our service usual care for Vit D          supplementation of children and adolescents seen in the paediatric nephrology          department.        -  and to study the effect of Vit D supplementation (100 000 IU vial of cholecalciferol) on          calciuria in these patients.   "
80026|NCT02238405|"     The primary focus of this intervention trial is to understand the effect of quitting smoking     on TB treatment outcomes. The investigators will compare a cessation strategy based on     guidelines recommended by the World Health Organization (WHO) and the International Union     against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly     observed therapy (DOT) clinics in Pakistan. The investigators study will provide     comprehensive data towards understanding the effectiveness of these strategies for TB     patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB     treatment outcomes. These findings will guide development of effective smoking cessation     strategies in a region with high prevalence of TB and increasing tobacco use.   "
80027|NCT02238392|"     This study investigates impact of adenosine versus AF inducibility and subsequent termination     on the acute and long-term outcome of paroxysmal AF ablation.   "
80028|NCT02238379|"     The objective of this study is to investigate the effects of oxytocin on social behavior and     brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is     its high temporal specificity, enabling precision in the timing of social behavior to be     addressed. In order to elicit social responses in the human brain, a variety of social and     emotional visual stimuli will be presented during EEG recording, namely infant and adult     faces and houses. Brain responses after intranasal oxytocin will then be compared with     placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We     hypothesize that intranasal oxytocin will enhance the neural response to social stimuli     (infant and adult faces) but not to non-social stimuli (houses).   "
80029|NCT02238366|"     The purpose of this study is to collect some parameters which may help to provide guidance on     how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.   "
80072|NCT02237807|"     The purpose of this study is to assess the bioequivalence of the investigational TEST product     with the marketed REFERENCE products by measurement of Plasma concentrations of     Erythromycylamine in plasma and calculation of the bioequivalence parameters from those     measurements followed by ANOVA and 90% confidence interval statistical evaluation.   "
80030|NCT02238353|"     Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine     and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The     combination formulation appeared to be superior in these patients with better symptomatic     relief. However, objective analysis of the effect of this treatment on nasal mediators and/or     nasal hyperreactivity has not yet been performed and would help in understanding the     additional benefit of the combination treatment over monotherapy with nasal corticosteroids.   "
80031|NCT02238340|"     Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the     patient, including significant cardiovascular and respiratory complications. Apart from the     human suffering that is undeniable pain. Schemes oral analgesia with opioids for the     treatment of DAPO, have shown to be as or more effective than intravenous or epidural     regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone     sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20)     undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone     metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at     rest and effort, requirement for rescue intravenous morphine and incidence of side effects to     the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and     patient satisfaction.   "
80032|NCT02238327|"     The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic     Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk     factors and that persistent viral infection including residual HIV is linked to HIV COPD.   "
80033|NCT02238314|"     The primary objective was to evaluate the antiviral activity and safety of two regimens of     tipranavir (500 mg BID or 1000 mg BID) plus ritonavir (100 mg BID) administered in     combination with 1 new nucleoside reverse transcriptase inhibitor (NRTI) + efavirenz in     multiple protease-inhibitor-experienced HIV-1 positive patients.   "
80034|NCT02238301|"     The purpose of this study is to evaluate the use of functional MRI in pregnant women as a     non-invasive diagnostic tool to detect placental insufficiency and differentiate healthy     fetuses from the intra-uterine growth restricted ones. Functional MRI in pregnant women can     detect a variation of the MRI signal (called BOLD effect) from the placenta and the fetus     when the mother is breathing pure oxygen. This study aims hence to demonstrate the difference     in the BOLD effect between normal feto-placental units and growth restricted ones.   "
80056|NCT02238015|"     To compare tear film differences between surgical eyes and nonsurgical eyes in patients who     had cataract surgery by phacoemulsification in one eye.   "
80057|NCT02238002|"     To investigate changes in anterior chamber angle configuration after phacoemulsification and     intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).   "
80058|NCT02237989|"     The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint     pain and function and its effects on urinary biological markers related to cartilage     degeneration in patients with knee osteoarthritis.   "
80059|NCT02237976|"     The proposed study is designed to utilize a self-hypnosis training program for patients     awaiting lung transplantation. This technique can increase their well being, particularly by     decreasing postoperative pain.   "
80035|NCT02238288|"     Patients using anticoagulants present an increased risk of bleeding when subjected to oral     surgery. Suspending or reducing the oral anticoagulant dose to perform invasive procedures,     may result in thromboembolic events, putting patients health in risk. Recent studies advocate     the dental surgery treatment without suspending the anticoagulant therapy, since the values     of the international normalized ratio (INR) are in acceptable therapeutic levels and local     measurements are taken for the hemostasis control. The aim of this study is to compare the     effectiveness use of intra-alveolar epsilon amino caproic acid (EACA) associated to daily     rinses with the drug, with routine post-surgical procedures, to control the post-exodontic     bleeding in anticoagulated patients. Patients will be referred by the anticoagulation clinic     of the Clementino Fraga Filho University Hospital. Once the study criteria is met patients     will be randomly allocated into two groups and subsequently subjected to clinical and     periodontal examination, radiographic examination and pre-operative periodontal therapy.     Laboratory tests (partial thromboplastic time, prothrombin time, international normalized     ratio and platelet count) will be held on the day of the extraction. Patients in group 1 (     EACA ) will receive a paste composed of 01 macerated EACA tablet (500 mg), mixed with 0.9%     saline solution in the alveolar socket, and routine post-operative care. Additionally,     patients will perform oral rinses three times a day, on the first two post-operative days,     with a solution from the macerated EACA 500mg tablet diluted in 2 spoons of filtered water.     Patients allocated in group 2 (control) will receive routine post-operative care.     Classification of immediate bleeding will be held by the professional, on the day of the     surgery, immediately after the suture and twenty minutes later and the delayed bleeding,     recorded by the patient through a daily questionnaire. The Statistical Package for the Social     Sciences (SPSS)© (IBM, Chicago, USA) 20.0 is used as the database and the Chi-square,     Kruskal-Wallis and Mann-Whitney tests will be applied to statistical analysis of the     results.The study was approved by the ethical and research committee of the Clementino Fraga     Filho University Hospital . All patients will sign a free consent and informed term.   "
80036|NCT02238275|"     Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice     prescribing-conditions   "
80037|NCT02238262|"     The aim of the observational study was to supplement the data on efficacy, safety and     tolerability of telmisartan under daily conditions in hospitals   "
80038|NCT02238249|"     Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in     daily clinical practice in Japanese paediatric patients with urticaria   "
80039|NCT02238236|"     Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in     daily clinical practice in Japanese paediatric patients with allergic rhinitis,     eczema/dermatitis, urticaria and pruritus   "
80040|NCT02238223|"     Study to investigate the safety and efficacy information of Alesion® Tablet under the proper     use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial     asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching   "
80041|NCT02238210|"     Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5     years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from     symptoms of rhinorrhea associated with allergies   "
80042|NCT02238197|"     To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml     inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under     conditions of daily practice   "
80043|NCT02238184|"     To obtain further information on the prescribing pattern and therapeutic long term value in     patients suffering from moderate or severs Chronic Obstructive Pulmonary Disease under     conditions of daily practice   "
80049|NCT02238106|"     The primary objective of this trial was to establish non-inferiority of lung function     response to two doses [25 μg (1 capsule) and 50 μg (2 capsules of 25 μg)] salmeterol,     administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene     (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg,     administered as the xinafoate salt) following single dose inhalation in patients with COPD. A     hard capsule with half the strength (12.5 μg) was included to investigate a dose ordering     effect.      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation     powder delivered by HandiHaler® 2 from the PE hard capsule(s) and salmeterol xinafoate     delivered by Serevent® Diskus®, and to compare the safety of the different pharmaceutical     forms and/or doses.   "
80050|NCT02238093|"     Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients.     Recently, its prevalence is rising. There are several different clinical presentations of     this syndrome. It has a high rate of morbidity and mortality.      The purpose of this study is to find the connection between the heart pathology and its     effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these     patients, and hopefully, aid in increasing their quality of life, and decrease their     morbidity and mortality.   "
80051|NCT02238080|"     This observational, multi-center, open-label, prospective study will evaluate the     relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and     methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease     (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene     glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene     glycol-epoetin beta.   "
80052|NCT02238067|"     This study is a prospective, non-interventional, cross-sectional multicenter survey. The aim     is to better understand the current therapy pattern for anemia in CKD treated with     erythropoiesis-stimulating agents (ESAs) and not on-dialysis participant population in     Israel. Participating physicians will be requested to interview eligible participants with     CKD not on dialysis and to complete for them a satisfaction survey for anemia treatment. The     survey will be completed twice, once at study start and once at six months' follow-up.   "
80060|NCT02237963|"     The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on     the surgical approach. The posterolateral approach is compared to the axillary approach     especially in term of development of a chronic pain.   "
80062|NCT02237937|"     The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy     within 28 days of treatment with approved antidepressants that are known substrates of the     P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.      Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved     antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the     blood-brain barrier expressed by the ABCB1 gene.   "
80063|NCT02237924|"     A total of 120 patients with pathologically confirmed locally advanced low-risk     nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60     patients in each group. One group was treated with intensity-modulated radiation therapy     (IMRT) combined with Endostar and the other group was treated with IMRT combined with     concurrent chemotherapy. The short term efficacy and the toxic and side effects of these     treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free     survival of patients were analyzed. Our data may provide an alternative option for the     treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low     toxicity.   "
80064|NCT02237911|"     Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve     many of the substantial functional limitations and physical inactivity that existed for a     long time prior to the surgery. Exercise is an intervention that could improve these     long-term limitations. To promote these improvements, exercise should be implemented at later     stage post TKR when patients can tolerate doses of exercise sufficiently high to promote     substantial changes. To date, we just don't have enough good research to tell us which type     of exercise works best for which patients and under which circumstances at later stage post     TKR. This research study will provide evidence for recommended interventions during the later     stage post TKR. The specific research questions are: (1) How do group exercise in the     community and individual exercise in rehabilitation clinic compare with usual medical care on     physical function and activity outcomes? (2) Who are the patients most likely to respond to     each exercise intervention? (3) Are the approaches safe?   "
80065|NCT02237898|"     Through a smartphone platform, financial incentives for smoking abstinence in postpartum     women can be delivered remotely, thus minimizing the need for participants to come to the     office to receive traditional contingency management.   "
80066|NCT02237885|"     Up to half of military veterans with traumatic brain injury (TBI) also suffer from     co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic     pain, one of the most common health complaints among U.S. veterans who served in Operation     Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn     (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate     that veterans perceive barriers to traditional mental health treatments. Little research     exists regarding non-pharmacological, technology-based interventions designed to reduce pain     in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG     biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain     in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of     using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI.     Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG     brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides     neurofeedback to induce relaxation). Veterans are taught how to use these together to do     neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary     data, we hypothesize that participants will show high levels of adherence to the NeuroSky +     Mobile Neurofeedback intervention for the 3-month study duration and that participants will     show statistically significant reduction in pain symptoms at 3 months compared to baseline.     Given links between pain and other outcomes in veterans, we will also explore effects on drug     abuse, violence, and suicidality. When the research is complete, the field will be changed     because we will know whether new technology reading EEG brainwaves can be used to treat     symptoms among individuals suffering from chronic pain. We will also know whether     neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to     reduce pain and related outcomes. If this program of research is successful, its impact will     be to shift approaches to managing pain in clinical practice, for both veterans and civilians   "
80067|NCT02237872|"     The primary goal of this study is to assess the accuracy of conventional fat fraction proton     MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using FDG-PET as gold     standard.      In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed     on a combined PET/MRI scanner under mild cold condition.   "
80075|NCT02237768|"     The purpose of this study is to assess the bioequivalence of the investigational TEST product     with the marketed REFERENCE products by measurement of Plasma concentrations of     Erythromycylamine and calculation of the bioequivalence parameters from those measurements     followed by ANOVA and 90% confidence interval statistical evaluation.   "
85520|NCT02166645|"     The purpose of this study is to determine whether patient positioning (prone and supine     positioning) contributes to the success of extubation in the immediate postextubation period     of preterm infants.   "
80079|NCT02237716|"     The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base     excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid     infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown     in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min     and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two     variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no     significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased     between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained     below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a     significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and     10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant     decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P <     0.001), which returned to the baseline after 20 min.   "
80080|NCT02237703|"     This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors     (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD).     The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15     trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed     healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one     PET study. The investigators will also carefully document trauma history, and collect     behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology     of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11     (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control     populations in an a priori defined PTSD circuit.   "
80081|NCT02237690|"     This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment,     two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference     (R) formulations of doxorubicin hydrochloride liposome injection in female patients with     ovarian cancer.      Each patient will be randomized to one of two treatment sequences (RT or TR) according to a     randomization scheme prepared prior to the start of the trial.There will be at least 4-week     apart between each single-dose administration. Serial blood samples for determination of free     doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK analysis will     be obtained in each cycle.      The 90% confidence intervals on the GMR(geometric mean ratio) of test to reference products     of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate     bioequivalence.   "
80082|NCT02237677|"     The objective of the proposed translational study is to test a model, based upon basic     science studies, exploring multisystem impairments in PTSD including endocannabinoid (eCB)     and glucocorticoids in the modulation of fear memories by examining the cannabinoid type 1     (CB1) receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators     propose that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral     response to the stressor is associated with an upregulation of the CB1 receptors and     insufficient glucocorticoid signaling.   "
80083|NCT02237664|"     Thoracic surgery is commonly associated with severe postoperative pain and marked impairment     of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is     assumed to result in better quality of life and less postoperative pain compared with     standard open thoracotomy, other investigators have reported comparable patient-reported     physical component summary and pain scores after VATS and thoracotomy during the first 12     months after lung resection.2 That study was non-randomized and 41% of the included patients     did not complete the follow-up period.2 VATS has recently been increasing in popularity as a     fast-track surgery with potential enhanced recovery after surgery.      Variety of approaches exist to manage pain after thoracotomy which could attenuate     post-thoracotomy pulmonary dysfunction. Epidural analgesia has been considered for many     decades to be the best method of pain relief after major thoracic surgery. In previous     meta-analyses,3-5 many investigators have reported that thoracic paravertebral blockade (PVB)     has comparable analgesic effects to thoracic epidural analgesia (TEA) in patients undergoing     thoracotomy.      Additionally, PVB has a better side-effect profile, lower rates of failed block and is     associated with a reduction in pulmonary complications.3-5 This could be extended to VATS to     enhance recovery after surgery owing to effective analgesia and fewer side effects.6-7      Patient-controlled analgesia (PCA) has been advocated as a favourable model for postoperative     analgesia, that allows a perfect match between intensity of pain and analgesic delivery,     improves the quality of analgesia and decreases the cumulative analgesic consumption.     Furthermore, the introduction of patient-controlled epidural analgesia (PCEA) with background     infusion during labour gave patients a sense of control over their analgesia, reduced the     total dose of local anesthetic administered, and had less motor block than those who receive     continuous epidural analgesia.8-9Patient-controlled epidural analgesia (PCEA) has become     increasingly popular for pain control after thoracotomy.10-12 In a previous preliminary     study, McElwain et al.13 have reported satisfactory analgesia after breast cancer surgery     with the use of PC-PVB, using either 15-min or 30-min lockout, that study did not include a     comparative arm with a continuous paravertebral infusion. Furthermore, Abou Zeid et al. have     reported comparable analgesia after thoracic surgery with the use of either     patient-controlled PVB had with the use of intrathecal morphine, that study was not     controlled and included few patients.14      The efficacy of the patient-controlled paravertebral blockade (PC-PVB) on the quality of     postoperative analgesia and pulmonary function after VATS has not yet been studied.   "
80084|NCT02237651|"     The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™     Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical     nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl     Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.   "
80085|NCT02237638|"     The primary objectives of this study are to investigate the safety and tolerability profile     of the therapeutic vaccine hVEGF26-104/RFASE and to determine the effective dose of     hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0     pg/mL.   "
80086|NCT02237625|"     Hypophosphatasia (HPP) is a rare inherited metabolic disorder characterized by defective bone     and teeth mineralization caused by mutations of the ALPL gene, which encodes for the     tissue-nonspecific alkaline phosphatase (TNSALP) isozyme, resulting in decreased serum and     bone alkaline phosphatase levels. To date, over 250 different mutations in the gene encoding     TNSALP have been associated with HPP. Clinically, the loss of TNSALP function results in     progressive skeletal impact as well as progressive impact on all other major organ systems.     It clinically manifests as rickets in infants and children and osteomalacia at all ages. The     severe form of the disease has been estimated to have a prevalence of about 1 in every     100,000 live births.   "
80087|NCT02237612|"     This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging     (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph     nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may     be a less invasive way of predicting the stage and grade of prostate cancer.   "
80088|NCT02237599|"     This study hypothesizes that an automated device using small electronic impulses can detect     nerve impairment in unconscious patients.   "
80089|NCT02237586|"     The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ)     via intravenous (IV) administration in three groups with different malaria immunity-status:        1. Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA)        2. Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS)        3. Adults without previous malaria episodes without sickle cell trait (HbAA)      Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear positivity     after challenge will be assessed. If in any of the groups with a history of lifelong malaria     exposure, 50% or less of individuals become thick blood smear positive during the 28 days     post injection of PfSPZ Challenge, the dose will be increased 4-fold to 12,800 PfSPZ in this     group.   "
80090|NCT02237573|"     In France, patients with benign viral infections (ie: gastro enteritis and/or     rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although     there is evidence that these medicines are not efficient.      We hypothesize that patients could be reassured by health advices, especially if they are     written. In addition, we believe that doctors would feel less guilty for not prescribing     drugs if they could hand written consultation reports to patients, in these situations.      We aim to assess the impact of handing to patients with viral gastroenteritis or upper     respiratory tract infections, a copy of the consultation report on their medicine     consumption.   "
80091|NCT02237560|"     The purpose of this study is to clarify the benefits to brain health and thinking processes     that result from different forms of exercise. This study will examine the effectiveness of     cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with     MCI, and compare this with the individual cognitive, behavioral, and physiological effects of     physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will     be greatest for combined aerobic and cognitive exercise compared to physical and mental     exercise alone.   "
80092|NCT02237547|"     Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear     Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected     intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.   "
80093|NCT02237534|"     The purpose of this study is to compare the effect of lanthanum carbonate and calcium     carbonate on the progression of coronary calcification and vascular endothelial dysfunction.   "
80094|NCT02237521|"     Patients with end-stage renal disease (ESRD) have a high prevalence of impaired glucose     metabolism. The pathophysiological cause is uncertain, but disturbances in the secretion,     elimination and effect of glucagon, insulin and the two incretin hormones glucagon-like     peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), probably play     important roles. Our research group has previously found that dialysis patients without type     2 diabetes mellitus (T2DM) have a reduced incretin effect and an inability to suppress     glucagon after a meal - two early pathophysiological characteristics of patients with T2DM     and normal kidney function.      The aim of the project is to provide a detailed description of the mechanisms underlying the     (patho)physiological effects of the incretin hormones in patients with ESRD. We plan to     investigate the above mentioned disturbances during fasting and hyperglycaemic conditions     using incretin infusions during glucose clamping. Furthermore, stable isotopic tracers will     be used to determine the effect of the incretin hormones on the endogenous glucose handling.      We hypothesise that the effects of the incretin hormones in ESRD will be reduced in respect     to healthy control subjects.   "
80095|NCT02237508|"     The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in     comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence of     the two products. Namely the study will compare the total systemic bioavailability (as an     indicator of safety), and it will compare the pulmonary bioavailability (as a possible     surrogate indicator of efficacy). This study will be performed in healthy subjects.   "
80096|NCT02237495|"     Cardiac surgery is associated with a high risk of cardiovascular and other complications. The     investigators hypothesized that perioperative infusion of dexmedetomidine may reduce the     incidence of complications and mortality following cardiovascular surgery.   "
80097|NCT02237482|"     This study is intended to compare the proximal migration of the tantalum design (TM) with a     cemented cup used in conjunction with bone allografting in cases with major bone loss. A     group of patients with good periacetabular bone stock are included to analyse the differences     between the tantalum and titanium design regarding risk of loosening and differences in     clinical outcome measures. Radiostereometry (RSA) is used to accurately measure migration and     rotation of the revision cups.   "
80098|NCT02237469|"     The study purpose is to evaluate whether or not clinical characteristics of women with breast     cancer can predict which position for radiation treatment, prone or supine, will be     associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation     dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed     dose to tumor bed and ipsilateral breast.   "
80099|NCT02237456|"     The purpose of this study is to compare optical coherence tomography (OCT) scans performed in     the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after     implantation of stents or bioresorbable scaffolds.   "
80100|NCT02237443|"     Anesthesia providers are taught to test that they can properly ventilate a patient's lungs     before administering a neuromuscular blocking drug (NMBD), rendering the patient apneic. This     is a traditional teaching, not based on empirical evidence. The investigators primary     hypothesis is that ventilation after the administration of NMBDs is non-inferior with that     before their administration with respect to the composite safety endpoint of inadequate (MVi)     and dead-space only (Vds) ventilation.   "
80101|NCT02237430|"     Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the     incidence of adverse access site related events in-hospital, at 30 days and at 6 months.   "
80109|NCT02237326|"     The clinical trial is part of a larger study to evaluate the safety and efficacy of screening     techniques for cervical cancer among HIV-infected women. The investigators randomized women     to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with     Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were     based on the colposcopy exam done at the study visit. The investigators then compared     outcomes between the two groups to assess the test characteristics of both VIA and VILI.   "
80102|NCT02237417|"     This is a Phase 4, randomized, open-label, parallel group study designed to assess the     clinical and biological effects of 12 months of treatment with long acting intramuscular (IM)     aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on     magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral     antipsychotic medications and compared with a healthy control group.      It is hypothesized that improved treatment compliance will lead to fewer white matter changes     in the brain. Fewer white matter changes will be demonstrated via neuroimaging as increased     FA and BPF values in the prefrontal region, and an increase in metabolites in a voxel     centered on the anterior cingulate cortex (ACC) as seen with MRS. Therefore, the aim of this     study is to examine the structural and metabolic effects of aripiprazole (Abilify®) once     monthly in patients with schizophrenia using MRI techniques and to examine these effects in     association with cognitive and clinical measures.   "
80103|NCT02237404|"     The purpose of this research is to estimate the outcomes in health and cost of the follow-up     of patients with pacemakers.      The initial hypothesize of this study is that remote monitoring of pacemaker will show a best     relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.   "
80104|NCT02237391|"     While significant advances in pain management have occurred in the last 20 years, the     majority of patients with chronic pain (CP) are unable to access evidence-based treatment at     either the primary or tertiary care level.      Moreover, research has shown that unrelieved CP and the lack of available expertise     contribute to emergency department (ED) visits and hospital admissions. At The Ottawa     Hospital (TOH), close to 18,000 ED visits per year are related to CP (12.9%). Among high     frequency visitors (HFV; >= 8 visits per year), a small number of patients with CP use an     inordinate amount of acute care resources. The investigators study will use a randomized     controlled (RCT) design to conduct a pilot evaluation of the impact of a Complex     Interdisciplinary Pain Assessment Program (CIPAP) linked with primary care physicians (PCP)     compared to a treatment as usual (TAU) control arm.      The investigators hypothesis is that implementing a CIPAP will increase health care value     through improved patient outcomes and reduced costs in HFV with chronic pain (CP-HFV). The     investigators believe that a CIPAP will provide CP-HFV patients long-term pain management     solutions, ED visits for CP will be reduced, and hospital admissions for CP will be     prevented. This pilot RCT study will inform a larger-scale RCT study to be conducted in the     future.   "
80105|NCT02237378|"     Right ventricular (RV) failure is the leading cause of death in pulmonary arterial     hypertension. (PAH) Right ventricular ejection fraction is one of the most important     predictors of prognosis in heart failure patients regardless of cause. It is estimated that     30-50% of patients with heart failure and preserved ejection fraction (HFpEF) have right     ventricular dysfunction and up to 70% of these patients will have significant pulmonary     hypertension (PH), both of which are related to much worse prognosis. Right ventricular     failure is becoming an increasingly prevalent and significant cause of morbidity in patients     with left heart disease. Despite the significance of RV function to survival, there are no     therapies available that directly or selectively improve RV function.      The overall theme of this research project is to evaluate the mechanisms that contribute to     the cause of right heart failure. This small study is designed to look at the role of heart     and lung metabolism and pulmonary hypertension as they relate to the development of right     heart failure in cardiovascular disease.(PH-LHD)   "
80106|NCT02237365|"     Tuberculous meningitis is a severe brain infection which often causes disability and death     even when treated with the best available treatment. Aspirin is a type of anti-inflammation     drug which can reduce the inflammatory response in brains of patients with tuberculous     meningitis, and therefore may decrease some of the most severe outcomes. This study compares     the use of aspirin (at 2 different doses) versus placebo as an additional therapy to the     standard treatment to see if aspirin is safe and helpful in reducing disability and death     from tuberculous meningitis. Patients will be treated with aspirin or placebo for 60 days and     followed up while on standard treatment for 8 months.   "
80107|NCT02237352|"     The prevalence of diabetes mellitus (DM) is increasing worldwide, suggesting that 45% of     diabetics are undiagnosed. DM induces a kidney disease called diabetic nephropathy (DN) which     is the largest single cause of end-stage renal disease and dialysis requirement. In South     America the prevalence of DM and chronic kidney disease has increased, and great disparity     exists among countries in regards to access to the dialysis treatment. It has been     considerate that Hispanic origin increases the risk for DM. The South Americans have     distinctive habits, culture, environment, behavior and genetic background and the factors     involved in DN have not been defined yet. The early kidney lesions such as neoangiogenesis     (pathologic generation of the new blood vessels) and extracellular matrix expansion have been     described. The vascular endothelial growth factor A (VEGF) has been linked to angiogenesis,     but the role of VEGF in DN has not been elucidated yet. VEGF signals mainly through VEGF     receptor 2 (VEGFR2). VEGFR2 interacts with alphaV beta3 integrin (AVB3) in kidney.     Additionally tenascin C is expressed in the extracellular matrix. Tenascin C and the tenascin     C/AVB3 complex have also been linked to angiogenesis, however their roles have not been     unveiled yet in the DN. Investigators hypothesize that VEGF signaling and tenascin C play an     important role in DN and that VEGFR2, AVB3 and tenascin C interact. The purposes of this     study is to characterize social, environmental and biological factors implicated in the DN in     Ecuador and define the role of VEGF signaling and tenascin C in the pathogenesis of the DN.     Investigators propose to study factors involved in DN in diabetic and non-diabetic adults     from general population, with and without DN. In a single time investigators will evaluate     demographics data, habits, personal and family history through a survey. Investigators will     measure anthropometrics parameters and blood pressure; investigators will quantify blood     glucose, glycosylated hemoglobin A1c and proteinuria. In addition investigators will examine     the role of tenascin C and VEGF signaling by analyzing paraffin embedded kidney tissue,     plasma and urine samples. Characterizing the factors involved in the DN from Hispanic people     is key to establish adequate strategies of prevention, diagnosis and treatment in this     population. Furthermore elucidating the role of proteins involved in DN may offer valuable     tools for the development of new treatments.   "
80123|NCT02237144|"     This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is     assigned at the village level where treatments are: cash transfers (north and south); cash     transfers + nutrition behavior communication change (north only); food transfers (north and     south); food transfers + nutrition behavior communication change (south only); food-cash     split (north and south); and controls (north and south). Within treatment localities, women     living in very poor households are targeted to receive benefits for two years.   "
80108|NCT02237339|"     The presence of Left ventricular hypertrophy (LVH) confers high cardiovascular risk in     hypertensive patients. LVH remains highly prevalent even when blood pressure (BP) is     controlled. There is increasing evidence that a major non-haemodynamic contributor to LVH is     oxidative stress. Allopurinol is known to markedly reduce oxidative stress.      This pragmatic randomised double blind placebo controlled trial will examine whether     allopurinol (300 mg bd) regresses LV mass as assessed by cardiac magnetic resonance (CMR) in     66 patients with treated hypertension but who have persisting LVH.      Endothelial and vascular function will also be assessed via flow mediated dilatation (FMD)     and pulse wave analysis respectively (PWA) and plasma biomarkers of oxidative stress will be     measured. The treatment (allopurinol or placebo) will last 12 months.   "
80124|NCT02237131|"     To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual     cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas     following fertility-sparing surgery.   "
80111|NCT02237300|"     Introduction: The purpose of this research is to develop a new component for     cognitive-behavioral treatment (CBT), empirically validated, for binge eating behavior in     patients with bulimia nervosa (BN) and binge eating disorder (BED), by means of cue-exposure     therapy (CET) with virtual reality. While CBT is an effective treatment for these eating     disorders, an important percentage of patients do not improve despite treatment. It is     necessary to explore how to enhance the effectivity of usual treatments with the     incorporation of new technologies and procedures. The innovation of this investigation is     based on the use of VR for cue-exposure therapy, which has been found effective with patients     resistant to conventional treatments (CBT and pharmacological intervention), and seeks to     enhance this efficacy by increasing possibilities of generalization and providing more useful     tools to clinicians, diminishing the logistic complications of the exposure to real cues     (food).      Participants: 60 patients with a diagnosis of BN or BED according the DSM-5 who had been     proposed for participation in the study by their referral mental health's professional after     conducting unsuccessfully a first level treatment (CBT structured intervention) at the     clinical sites involved will participate in the study.      Procedure: Participants with active episodes of binge eating (and purging, in the case of BN)     during the last 2 weeks of the structured intervention of CBT will be provided with detailed     information about the study. All patients who agree to participate in the study and who sign     the informed consent form will be randomly assigned to one of the two second-level treatment     conditions: virtual reality based cue-exposure therapy (VR-CET) or additional     cognitive-behavioral treatment (A-CBT). Both second-level treatment conditions consist of six     60-minute sessions that are held two times per week over a period of three weeks.      In an interview setting, all of the participants will be administered several questionnaires     (BN, DT and BD subscales of EDI-3, FCQ-T/S, and STAI-Y) and participants assigned to the     VR-CET will also be exposed to various types of virtual foods in different virtual     environments (kitchen, dining-room, bedroom, and café) where they will be asked about their     food cravings and anxiety experienced in each situation to develop a proper exposure     hierarchy according to the specific characteristics and needs of each patient.   "
80112|NCT02237287|"     Background: The wound healing promoting effect of negative wound pressure therapies (NWPT)     takes place at the wound foam interface. Implementation of bioactive substances at this site     represents a major research area for the development of future NWPT devices.      Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices     with or without the implementation of a thin interface of poly-N-acetyl glucosamine     nanofibers (sNAG) was studied in a prospective randomized clinical trial.   "
80113|NCT02237274|"     Important advances in cardiac surgery, intensive care, and diagnostic modalities over the     last decades have led to a steady growth in the number of adults with congenital heart     defects. Among adults with congenital heart disease, patients with a Fontan circulation     typically show the lowest values of peak oxygen consumption. For these patients, strict     exclusion from activities at high altitude may have an impact on quality of life. The     investigators aim to elucidate the short term effects of a stay at high altitude on     hemodynamic adaptation, exercise capacity and clinical well being in adult Fontan patients.     The investigators hypothesize that patients with a Fontan circulation in NYHA functional     class I-II are able to increase their cardiac output during exercise at high altitude in     order to meet the required metabolic demands and therefore tolerate the journey to the     Jungfraujoch well.   "
80114|NCT02237261|"     The purpose of this study is to improve efficacy of treatment for patients with newly     diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by     autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.   "
80115|NCT02237248|"     The purpose of the study is to examine the changes in function and performance biomechanics     in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis     (AIS).   "
80116|NCT02237235|"     The goals of this study are to study MMFS-202-302 in a double blind, randomized,     placebo-controlled 9-week study of its effect on ameliorating cognitive deficits in 60     patients with schizophrenia or schizoaffective disorder with stable levels of positive     symptoms. Secondary end points will include changes in positive and negative symptoms. One     dose of MMFS-202-302 will be studied and compared with placebo as adjunctive treatment to     atypical antipsychotic drug treatment.   "
80117|NCT02237222|"     The aims of this project are to evaluate the psychometric properties of the German versions     of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette     Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years     with a neuromuscular diagnosis.   "
80118|NCT02237209|"     Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around     the world. This study will evaluate the safety and immune response to an RSV vaccine in     RSV-seronegative infants and children.      This study is a companion study to CIR 291.   "
80119|NCT02237196|"     This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an     investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal lymphopoietin]     antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat     allergen.The objective of the study is to determine whether one year of immunotherapy     combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.   "
80120|NCT02237183|"     This randomized phase I trial studies the side effects and best dose of iloprost compared     with a placebo in preventing lung cancer in former smokers. Chemoprevention is the use of     drugs to keep cancer from forming or coming back. Inhaled iloprost may help prevent lung     cancer from forming in patients who used to smoke and who have been found to have abnormal     cells in their mucus.   "
80121|NCT02237170|"     The purpose of this protocol is perform comprehensive immune monitoring studies in patients     with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better     understand the mechanism of action of this treatment.   "
80122|NCT02237157|"     A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the     pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.   "
80126|NCT02237105|"     This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the     outcome of spinal surgery.      The goal of this treatment is to change the coping style, thoughts, behavior and adaptive     perception of the patient, and to replace them with an adaptive style.      The patients in this study will be randomly divided into two groups. One group will undergo     Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a     control group, and will not have any psychological intervention.   "
80127|NCT02237092|"     It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the     volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute     to the development of more high spinal block.   "
80128|NCT02237079|"     The goal of this pilot clinical study is to perform a randomized placebo-controlled study to     assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens     (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women.     The recruitment will be performed at Tulane Health Sciences Center.   "
80129|NCT02237066|"     The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous     Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence     Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular     response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with     the primary endpoint being luminal gain assessed by OCT lumen volume measurements.   "
80130|NCT02237053|"     The purpose of this study is to collect data to help researchers better understand the     effects of glucagon on the amount of calories burned.   "
80131|NCT02237040|"     This study aim to evaluate the clinical and radiographic outcomes of mandibular condylar     fractures in pediatrics treated simply with a mandibular manipulation technique accompanied     by mouth opening training.   "
80132|NCT02237027|"     In the last few years, early treatment of HIV-infected individuals, or treatment as     prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative     people at very high-risk of acquiring the infection (PrEP) have emerged as highly promising     biological preventive interventions to tackle the HIV pandemic within the framework of     combination prevention, a multi-component strategy that has been promoted for the last five     years. In West Africa, the evidence strongly suggests that female sex workers (FSWs)     contribute very disproportionally to the HIV spread. This is why the investigators propose     this TasP and PrEP demonstration project in Benin, where our group has been involved in HIV     prevention research in the sex work milieu for the last two decades.      After a run-in phase for community preparedness and the development of a specific education     program on adherence, the investigators plan to recruit 100 HIV-infected FSWs in the TasP     component of the project (these women will receive a first-line antiretroviral treatment     (ART) regimen as per the Benin guidelines) and 250 HIV-negative FSWs in the PrEP component     (these women will receive Truvada®). The recruitment period will last for one year, followed     by an additional one year of follow-up, for a total follow-up period varying between 12 and     24 months, depending on when a given woman is recruited in the study. During follow-up visits     every three months, the investigators will closely monitor treatment adherence and changes in     sexual behaviour, including the use of viral load testing among TasP participants and     Truvada® plasma level testing for PrEP participants, as well as detection of     prostate-specific antigen (PSA) and Y-chromosome DNA in vaginal fluids in all participants.      The investigators will evaluate the feasibility of TasP and PrEP through a set of indicators,     including uptake, coverage, adherence, condom migration, occurrence of side effects and     development of drug resistance, whereas mathematical modeling will be used to predict the     potential impact of both interventions in the sex work milieu and the general population,     based on the actual set of indicators observed. The study will be completed by an economic     evaluation of the interventions and a cost-effectiveness analysis.      Finally, the investigators will disseminate the results to the study population and to the     Beninese health authorities and ensure the broad implementation of these interventions in     Benin if the demonstration project shows that they are feasible and relevant.   "
80133|NCT02237014|"     Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen     saturation, but the gold standard for arterial oxygen saturation is co-oximeter which     requires an arterial blood sample. The purpose of this research study is to determine the     accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the     study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against     co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen     saturation noted in children with cyanotic heart disease. Hence therapeutic interventions     (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be     delayed and or inadequate. By doing this study the investigators will be able to establish     correct limits of peripheral pulse oximeter when using the standard and the study sensors.   "
80134|NCT02237001|"     Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used     suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the     repair, by assessing the re-operation rate, and by assessing improvements in knee pain and     knee function.   "
80135|NCT02236988|"     To study how the body absorbs apremilast, and how this absorption is affected when the drug     is given as different formulations. Blood samples will be taken to look at the amount of     study drug in the blood to determine how much apremilast is absorbed by the body. This study     is beng done to iddentify the best tablet formulation (preparation) of apremilast.   "
80136|NCT02236975|"     Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus     Resolute Integrity conducted in approximately 14 interventional cardiology centers in The     Netherlands, Belgium, Spain and Portugal.      Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients     will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at     baseline (pre- and post-procedure) and at 9 months follow-up.   "
80137|NCT02236962|"     Obesity is epidemic in Australia, and current preventative strategies have had limited     success in alleviating this health crisis. While numerous options are available for treatment     of obesity, most do not result in sustained weight reduction. Obesity results from an     imbalance between energy intake and expenditure, therefore new methods that correct this     imbalance are essential for effective long-term treatment. Rodent studies show that brown     adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore     targeting BAT to increase its activity (energy burning rate) and quantity in humans is     potentially a powerful tool for the treatment of obesity and related diseases. BAT has only     recently been irrefutably identified in adult humans therefore little is known about how it     functions in humans.   "
80169|NCT02236546|"     This clinical trial studies how well FDG-PET/CT measures early response in patients with     stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography     (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, [18F]fluorodeoxyglucose     (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before,     during, and after treatment may improve methods for predicting which patients may benefit     from therapy.   "
80138|NCT02236949|"     The purpose of this research study is to evaluate the effectiveness of short refresher     sessions. Pain Practice Change Boosters given at regular intervals to sustain improved pain     process (assessment and management) and clinical outcomes (pain intensity) achieved during a     15 month knowledge translation intervention, Evidence-based Practice for Improving Quality     (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that affect that     sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the effectiveness of     the EPIQ intervention in 32 hospital units (4 units at each hospital site). 16 hospital units     were allocated to the intervention group and 16 units continued with standard care. The     current study focuses on the 16 hospital units that implemented the EPIQ intervention only.   "
80139|NCT02236936|"     Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and     Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result     in higher treatment related toxicity and discontinuation of a potential curative treatment.     Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (PN)     support in patients with SCCHN treated with curative radiotherapy (RTX) in combination with     Cetuximab (E) or Cisplatin (P).   "
80140|NCT02236923|"     That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter     length of stay in patients undergoing repair of aortic dissection, after adjusting for     seasonal effects, demographics and cardiovascular risk factors.   "
80141|NCT02236910|"     Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as     being effective in controlling symptoms and increase quality of life; induce stable disease     and extend progression free survival; induce a (good) partial remission and induce a complete     remission in patients with a somatostatin receptor positive tumour.      The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression     free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE,     and the quality of life of the patients treated with Lu-DOTA-TATE.   "
80142|NCT02236897|"     This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and     monitoring progression of ALS, based on a well established basic science pathway, published     human autopsy data, preliminary data in ALS mutant mice, and our recently published data     using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy     human volunteers.   "
80143|NCT02236884|"     During the past three years, a revolutionized radical surgical approach for rectal cancer     (down to up TME  approach or transanal TME (TaTME)approach, which is opposite to the     conventional approach) has emerged and it is a concept that combines natural orifice     transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative     intent. The feasibility, safety and reproducibility of it were first demonstrated in swine     survival experiments and subsequently in human cadaver series, and then it was successfully     applied to human patients in few centers around the world, most of which were performed with     assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without     conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases     were more limited. In the initial stage, our group has successfully performed this no-scar     transanal TME in a series of human cadavers with satisfactory outcome. Hence the     investigators conduct this study, looking to see if this pure transanal NOTES investigational     procedure is a safe and effective approach to radically remove rectal cancer of the mid and     lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function     and life quality when gaining the best cosmetic effect.   "
80144|NCT02236871|"     The final stages in the development of peak bone mass (PBM) reside in late adolescence or     early adulthood and are critical in the achievement of bone health. Optimization of PBM and     maintenance of bone mineral density (BMD) are the best population health strategies in the     primary prevention of osteoporosis. Diet and activity are key lifestyle factors in the     primary prevention of osteoporosis as recognized in Canada's Food and Activity Guides.     Dietary Reference Intakes are evidence-based regarding nutrition and bone health with a focus     on calcium and vitamin D; yet the Food Guide and health behaviors are reliant on actual     foods. The number of recommended servings of milk and alternatives varies by age with average     intakes estimated to be below targets for all Canadians > 9 y of age. This is especially     concerning during development of PBM. Therefore, the global objective is to generate     high-level evidence that dietary intervention with milk and milk products will enhance PBM in     young men and women and maintenance of BMD in their parents.      The primary objective is to demonstrate in healthy young men and women (14-18.9 y at     baseline) with habitually low usual milk and milk product intakes that intervention with     greater milk and milk product consumption improves lumbar spine BMD in a dose-response manner     over 2 y (while accounting for body size, physical activity, demographics and age). Healthy     young men and women will be recruited and screened for usual intake of milk and milk     products. Those with low intakes < 2 servings of milk or milk products will be randomized     (stratified by sex and age) to 1 of 3 groups for the RCT (n=10090/group): maintain usual low     intakes (<1 serving), improved intakes (average of 2 servings/d) or recommended intakes (≥3     servings/d) of milk and milk products. A manualized motivational interviewing framework will     be used for the interventions. Those meeting recommendations at screening will form a     longitudinal cohort for 2 y. Key measurements include baseline and yearly assessment of BMD     at multiple sites plus interim assessment of general health, anthropometry, dietary intakes,     physical activity and biomarkers of calcium homeostasis; and in the young adults bone     metabolism.   "
80145|NCT02236858|"     Objectives (include all primary and secondary objectives)      Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality     will improve respiratory symptoms, quality of life, lung function and reduce risk of     exacerbations in former smokers with COPD.      Hypothesis: An intervention using HEPA and carbon filter air cleaners in homes of former     smokers with COPD will improve respiratory symptoms, quality of life, and lung function and     reduce risk of COPD exacerbations compared with placebo (sham air cleaners).      Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality     will be associated with intermediate outcome measures known to be linked with long term     outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress,     in former smokers with COPD.      Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers     smokers with COPD will be associated with lower levels of markers of inflammation and     oxidative stress known to be associated with adverse outcomes in patients with COPD.   "
80146|NCT02236845|"     The study will assess the safety, tolerability and feasibility of Lacrima investigational     medical device vs. sham device in adult patients with chronic Insomnia   "
80147|NCT02236832|"     Frontal patients are impaired in categorisation and analogical reasoning tasks, and different     functional imaging studies from our group have shown the involvement of the prefrontal cortex     in categorisation and analogy tasks. The aim of this project is to test our hypotheses about     the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.   "
80148|NCT02236819|"     There is considerable variation in the incidence of out-of-hospital cardiac arrest (OHCA)     across Europe. The likelihood of attempted resuscitation also varies. To better understand     the factors that contribute to variation, more data on incidence, management and outcomes     from OHCA is required. A European, multi-centre study provides the opportunity to uncover     differences throughout Europe and may help find explanations for these differences. Results     may also have potential to support the development of quality benchmarking between European     Emergency Medical Services (EMS).      This prospective European study will involve 27 different countries. It provides a common     Utstein-based dataset, data collection methodology and a common data collection period for     all participants, thereby potentially increasing comparability.      Study research questions will address the following: OHCA incidence in different European     regions; incidence of cardiopulmonary resuscitation (CPR) attempted; initial presenting     rhythm in patients where bystanders or EMS starts CPR or any other resuscitation     intervention; rate of any return of spontaneous circulation (ROSC); patient status at     handover to a hospital i.e. ROSC, ongoing CPR, dead; incidence of patients still alive 30     days after OHCA; incidence of patients discharged alive from hospital.   "
80149|NCT02236806|"     The aim of the study is to analyze the protective impact on the cardiac damage of beta     blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based     chemotherapy with or without trastuzumab.   "
80150|NCT02236793|"     The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB     applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as     compared to Standard of Care alone for the treatment of neuropathic and neurovascular     diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile     normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB     will be applied on patients of the control group).   "
80151|NCT02236780|"     The main purpose of the study is to assess the impact of environmental conditions on     live-birth rates after intraconjugal IVF.      The second purposes are        -  to assess the impact on pregnancies (prematurity, preeclampsia);        -  to assess the impact on newborn's health (stunted growth);        -  to evaluate the consistency of results observed between assisted pregnancies and          spontaneous pregnancies.   "
80152|NCT02236767|"     This is multiple baseline study including up to three participants with a primary diagnosis     of hoarding disorder. All patients will receive unblinded repetitive transcranial magnetic     stimulation study intervention.   "
80153|NCT02236754|"     Type 1 diabetes mellitus (T1DM) develops when there is impaired insulin production due to     loss of insulin producing cells (beta cells). The amount of insulin that can be produced is     imperfectly correlated with beta cell mass (BCM). The development of a reliable method to     noninvasively quantify the total amount of insulin producing beta cells would be of great     benefit by providing an important endpoint for the development of new treatments of diabetes.     The investigators have previously identified a specific marker on islet cells called     vesicular monoamine transporter 2 (VMAT2) that the investigators now propose to use in     positron emission tomography (PET) scanning to determine islet beta cell mass. The PET     radiopharmaceutical 18F-fluoropropyl(FP)-dihydrotetrabenazine(DTBZ) has been used previously     in human subjects without adverse effects. It has shown promise in differentiating type 1     diabetes and non-diabetes. The investigators now hypothesize that repeat PET scans will be     reproducible in the same subject. Subjects with normal BCM will be recruited from among     normal weight non-diabetic people with plasma insulin levels within the normal range.     Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have     low or non-measurable insulin levels. Two PET scan measurements will be taken in each subject     and the amount of VMAT2 in the pancreas will be and compared for reproducible findings.     Biochemical testing will also be performed and compared to PET scans as a potential indirect     marker of beta cell mass.   "
80154|NCT02236741|"     Study to assess the risk of incident heart failure associated with the use of pramipexole     compared with other dopamine agonists and additionally, to assess the risk of incident heart     failure associated with the use of dopamine agonists in comparison with no use of dopamine     agonist therapy   "
80155|NCT02236728|"     The primary objective of this study was to describe neurologists' population of patients     treated with pramipexole and suffering from Parkinson's disease (so called 'primary care'     population).      The secondary objectives were:        -  Evaluate the mean dose of pramipexole prescribed under actual conditions of use          depending on the severity of the disease.        -  Evaluate the reasons for choosing pramipexole as treatment.        -  Identify the patient profiles determining the choice of dose of pramipexole prescribed   "
80156|NCT02236715|"     Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose     vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of daily     practice   "
80157|NCT02236702|"     The purpose of this study is to use positron emission tomography (PET) imaging to measure the     activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed     individuals.   "
80158|NCT02236689|"     Tennis elbow is a common occurrence in the general population that causes lateral elbow pain     and diminished grip strength, which may be debilitating. Most affected individuals achieve     symptom resolution within 6 months to 1 year with measures such as physiotherapy,     anti-inflammatories and corticosteroid injections, but a small subset will go on to develop     chronic symptoms. Chronic tennis elbow can be treated surgically, with arthroscopy gaining     popularity in recent years as it presents a less invasive option, allows for direct     visualization of the elbow joint for other pathology and has a faster return-to-work time     compared to other surgical procedures. Despite its promise there have been no high quality     studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual     efficacy of this procedure into question. We propose a randomized, double-blind controlled     trial comparing arthroscopic release with arthroscopic debridement for the management of     chronic tennis elbow in an effort to definitively answer this question and provide better     recommendations for the use of this procedure.   "
80159|NCT02236676|"     The purpose of this research study is to better understand how a daytime nap after training     on a motor skill after brain injury improves performance compared with the same amount of     time after training spent awake and resting.   "
80160|NCT02236663|"     Intimate partner violence (IPV), including violence in dating relationships (dating violence,     DV) is a widespread and serious public health problem. Among U.S. female IPV survivors, 47.1%     report their first abusive relationship occurred at college age (age 18-24). Similarly, in     national surveys, adults respondents 18-24 years of age report the highest rate of stalking     victimization, most commonly by a former intimate partner. Safety planning is the most widely     used intervention to prevent and respond to IPV, yet the vast majority of abused women never     access safety planning services. Our challenge is to increase college women's access to     safety planning, with the opportunity to consider their unique safety priorities and level of     danger during and when ending an abusive relationship. In addition, while bystander     interventions that train peers to safely intervene have been shown to be effective in sexual     assault prevention on campus, and college women in abusive relationships most frequently     disclose IPV to a friend, no similar interventions have been tested with friends for IPV     response on campuses. Therefore, the objective of the study is to evaluate the:        1. effectiveness of an interactive, personalized smart phone and web based safety          application (App) intervention in Maryland and Oregon with: 1) college women (age          18-24) who experience IPV and 2) friends (age 18-24) of women experiencing IPV. The          safety decision App allows the user to enter information on: a) relationship health; b)          safety priorities; and c) severity of violence/danger in relationship. The App then uses          the information to provide the user with a personalized safety planning information and          resources; and        2. dissemination of the App in an expanded four states (Arizona, Maryland, Missouri, and          Oregon) to determine the reach, adoption, implementation and maintenance of App use          among university/college students.   "
80161|NCT02236650|"     The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones     Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve     the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years),     increase parental resilience and decrease parental stress.   "
80162|NCT02236637|"     The purpose of this registry is to document the characteristics and management of patients     with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice,     independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments,     there is a need for a current and improved understanding of how these treatments fit into the     current treatment paradigm for mCRPC, how they are combined and sequenced, and how their     relative effectiveness profiles emerge outside of a clinical trial setting. This will be     based on documentation and description of sequencing of treatment initiation, termination,     and duration; relative effectiveness of treatments; defined medical resource utilization     (MRU) and quality-of-life parameters and follow-up for survival.   "
80163|NCT02236624|"     The purpose of the present study is to test the hypothesis that aerobic training can reduce     flu-like symptoms following interferon beta 1a injections in patients with Multiple     Sclerosis.      A secondary purpose is to evaluate whether or not changes in circulating cytokines provide a     mechanism that can explain a potential positive effect.   "
80164|NCT02236611|"     This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed     to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily     [QD]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD)     administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At     the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive     umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via     BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at     Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after     Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and     Day 85 (Visit 7). The total duration of subject participation in the study will be     approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1 (forced     expiratory volume in one second) on treatment Day 85. All subjects will have spirometry     performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours     after the previous day's dose of open-label study medication at Visits 3 to 7.      BREEZHALER is a registered trademark of Novartis AG.   "
80165|NCT02236598|"     African Americans suffer a disproportionately high risk of diabetes compared to other     Americans. Reasons for race disparities in diabetes incidence are not completely understood.     Although a difference in prevalence of obesity does explain a significant portion of the     racial disparity in diabetes risk, it does not explain all of this disparity. Strategies to     control the diabetes epidemic and reduce its racial disparity often overlook preventive     measures. Currently, the most powerful known strategy for preventing diabetes is weight loss     in the overweight/obese. However, because weight loss is often difficult to achieve and     maintain, other opportunities to prevent diabetes should be identified, particularly in     African Americans. Among potential novel opportunities is correction of low or low-normal     potassium levels (hypokalemia). In secondary analyses, we have found low-normal potassium (K)     to be a novel risk factor for diabetes; and we have found that this association between low-K     and diabetes risk may be stronger in African Americans compared to whites. Therefore, a     previously unrecognized alternative or adjunct strategy for preventing diabetes, particularly     in African Americans, may involve correction of low or low-normal K levels (hypokalemia).     Large-scale, adequately-powered, randomized controlled trials are needed to establish the     effectiveness of this approach. However, prior to those trials, the pathophysiology of the     association between low K and poor glucose metabolism must be understood. This pilot clinical     trial will begin to determine the effect of K supplementation on measures of glucose     metabolism in African Americans.      In this pilot clinical trial, 30 African Americans with prediabetes and a low-normal serum K     [<4.0 milliequivalent/Liter (Eq/L)] will be randomized to K-supplements, 20mEq (2-10mEq     tablets) twice daily or a matching placebo capsules twice daily. Prior to randomization,     baseline measures will be taken including measures of glucose metabolism with a 3-hour oral     glucose tolerance test (OGTT), baseline chemistries and a baseline 24-hour urinary potassium     measurement. Patients will take the intervention daily and will undergo repeat testing of all     of these measures at the end of a 3 month period. The primary endpoint will be change in     glucose tolerance, as measured by change in glucose area-under-the-curve (AUC) of a 3-hour     oral glucose tolerance test (OGTT). Secondary endpoints will include changes in fasting,     1-hour, and 2-hour post-challenge glucose levels, as well as measurements of insulin     secretion and insulin sensitivity as measures by the oral glucose minimal model method.(1)     The baseline data from this trial will allow us to quantify abnormalities in glucose     metabolism in African Americans with prediabetes/early diabetes and low-normal serum K. The     post-intervention data will provide estimates of the impact of K-supplements compared to no     supplements on these abnormalities. Data derived from the pilot study will be used in the     design of a larger scale, adequately powered clinical trial. This trial will also help to     assess the feasibility of recruiting this target population.      With this pilot trial, we will begin to determine whether or not K-supplements, an     inexpensive, well-tolerated, and simple intervention, could help to reduce diabetes risk     among African Americans.   "
80166|NCT02236585|"     Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata     through induction of infarction and subsequent hyaline degeneration. This could be followed     with variable severity of pain that lasts for several days after the procedure secondary to     the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been     described as moderate to severe cramping increasing over the first 2 hours after UAE to reach     plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The severity of     pain after UAE seems unrelated to the uterine or fibroid size which makes the severity of     pain is unpredictable.1      Pain management after UAE most often consists of a combination of a non-steroidal     anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following     embolization of the uterine arteries may require large doses of parenteral opioids for relief     with added unwanted effects.2      Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA)     after UAE needed considerable amounts of morphine (median [range] 24 mg [0-86 mg]) during the     first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce morphine     consumption for the first 24 hours after UAE. 2      Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic     choice for uterine artery embolization as it improves patients satisfaction and reduces the     severity of post-procedural pain.      Although some investigators suggest an epidural analgesia for pain control after UAE,4 the     use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain     management after UAE.5      Thus in an observational study included few patients, the investigators demonstrated     considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of     patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the     catheterization of thoracic epidural space in such low-risk patients has many logistic     issues.      Up to the best of our knowledge, there is no available comparative randomized clinical trial     compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.   "
80167|NCT02236572|"     The purpose of this study is to see whether adding everolimus to hormone treatment before     breast surgery will increase the chances of shrinking the breast cancer in those patients     with hormone-responsive breast cancer and a lower Oncotype DX® Recurrence Score ( 25 or     less), compared to prior experience with hormone therapy alone. Everolimus is a drug     currently approved for use by the United States Food and Drug administration (FDA) for the     treatment of patients with advanced or metastatic kidney or breast cancer. Everolimus is     considered investigational for non-metastatic breast cancer patients.   "
80168|NCT02236559|"     The overall objective of this study is to determine if Vapotherm high flow nasal cannula     therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to     the current standard of care for non-invasive ventilatory support, non-invasive positive     pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that     HFT has possible advantages over NIPPV, such as decreased time to patient stability from     respiratory failure, and the ease of use as a first line intervention for respiratory failure     in the ED environment.      The hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical     non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact     on ventilation indices and a lower intolerance rate, and have a positive association with     hospital disposition and length of stay.   "
80171|NCT02236520|"     Cardiovascular disease is the first common cause of death worldwide. Hypertension is the     number one driving risk factor. Hypertension has long been associated with dietary salt     intake. We believe that the accumulation of salt in the interstitium and inside cells     represents a neglected risk factor, which initiates a pro-inflammatory state, chronically     increases blood pressure, and leads to systemic energy imbalance. We will explore the concept     that Na+ storage in the skin and in muscle is associated with increased blood pressure, a     pro-inflammatory state, and reduced insulin sensitivity. We will do so by addressing the     following specific aims:        -  Specific Aim 1: To test the hypothesis that African Americans are characterized by          increased tissue Na+ storage, which is paralleled by higher blood pressure, reduced          forearm blood flow, and enhanced pulse wave velocity        -  Specific Aim 2: To test the hypothesis that treatment with spironolactone reduces tissue          Na+ content        -  Specific Aim 3: To test the hypothesis that Na+ storage leads to immune cell activation        -  Specific Aim 4: To test the hypothesis that the accumulation of salt in skin and muscle          is associated with decreased insulin sensitivity and propensity to diabetes mellitus   "
80172|NCT02236507|"     Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry     equipment and has been recently introduced into clinical practice. It is the most precise     method to assess the anal sphincter pressure function and may be crucial for planning and     controlling surgical procedures of the anorectal area. Normal values in pediatric population     have not been established.      The aim of this study is complex evaluation of anorectal function in children without     symptoms from lower GI tract and establishment of normal values.   "
80173|NCT02236494|"     This is a randomized trial to assess the value of an emergency department-based intervention     to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will     result in a 25% reduction in the prevalence of hazardous alcohol use while the control group     will only have a 5% reduction.   "
80174|NCT02236481|"     The TRACK [Treatment of Rheumatoid Arthritis and Comorbidities with Kineret     (anakinra)]-study: a randomized, open-label multicenter study assessing the efficacy of     anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid     Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Giacomelli,(A,B) P. Cipriani     (A) and P. Ruscitti (A) on behalf of the TRACK study-group; (A) University of L'Aquila,     L'Aquila, Italy; Background: Interleukin-1 (IL-1) plays a pivotal role in R.A., joint erosion     and cartilage destruction.(1) Anakinra (a recombinant form of the naturally occurring IL-1     receptor antagonist (IL-1Ra), which blocks the activity of both IL-1α and IL-1β) has shown in     a number of RCTs (2-6) to be effective in the treatment of R.A., in monotherapy,(2,4) as well     as associated to methotrexate (MTX).(3,5,6) IL-1β plays also an important role in the     pathogenesis of T2D: Glucose has been shown to induce IL-1β hypersecretion through     inflammasome activation, while IL-1β induces impairment of β-cell secretory function and     β-cell apoptosis.(7) In prediabetic subjects, the expression of IL-1Ra is induced by IL-1β     and reflects the body's response to counterbalance increased IL-1β activity.(7) Levels of     IL-1Ra tend to rise up to 6 years before the diagnosis of T2D.(8,9) IL-1Ra has been     successfully used as a marker for the risk of developing T2D in subjects with metabolic     syndrome.(10) As a clinical proof of concept, IL-1 inhibition with anakinra in patients with     T2D has shown to improve the secretorial function of beta-cells as well as to lower the ratio     of proinsulin/insulin and glycated hemoglobin/hemoglobin significantly, favoring glycemic     control and possibly reducing the severity and prevalence of the associated complications of     this disease.(11) Summarizing, IL-1 inhibition with anakinra has a clinical impact on R.A. as     well as T2D. As from 6-10% of Italian R.A. patients have also T2D, this trial aims at     investigating the impact of IL-1 inhibition on both diseases. Very recent data also show that     T2D is a predictor of response to anakinra-treatment in R.A. patients,(12) which furthermore     justifies the use of anakinra in this subset of R.A. patients. Objectives: [Primary] To     evaluate the change in HbA1c between baseline, 3 months, 6 months, 1 year and at last follow     up of 2 years from the beginning; [Secondary] To evaluate the efficacy on controlling signs &     symptoms of R.A., assessing the remission rate at 3 months, 6 months, 1 year and at follow up     (2 years), using the evaluation scale of disease activity on 28 joints, DAS28 and SDAI     improvements from baseline conditions over time points, according to EULAR response criteria.     Methods: 200 patients in 28 Italian centers with active R.A. refractory to treatment with     methotrexate and T2D will be enrolled and randomized to receive either 100mg of anakinra once     daily by subcutaneous injection or any anti-TNF-alfa drug treatment. [84 subjects will be     required in each treatment arm to reach 90% power with an alpha error of 0.05 to detect a     mean difference between the study arms of 0.25 percentage points of HbA1c . The assumed     difference of HbA1c is rather conservative when compared to previously published changes in     T2D patients (11).] Anti-diabetic treatment is required to be unchanged for at least one     month prior to enrolment. Patients will be invited to maintain dietary habits and lifestyle     during the study period. Further details can be viewed on the trials website after     subscription.(13) References: (1) Arend & Dayer, Adv. Imm. 1993; 54: 167-227. (2) Bresnihan,     Arthritis Rheum. 1998; 41: 2196-2204. (3) Cohen, Arthritis Rheum. 2002; 46: 614-624. (4)     Nuki, Arthritis. Rheum. 2002; 46: 2838-2846. (5) Cohen, ARD 2004; 63: 1062-1068. (6) Cohen,     Rheumatology 2004; 43: 704-711. (7) Donath, Nat. Rev. Immunol. 2011; 11: 98-107. (8) Herder,     Diabetes Care 2009; 32: 421-423. (9) Carstensen, Diabetes 2010; 59: 1222-1227. (10) Luotola,     J. Intern. Med. 2011; 269: 322-332. (11) Larsen, NEJM 2007; 356: 1517-1526. (12)     Missler-Karger, EULAR 2013, Abs. FRI0219. (13) http://www.anakinra-ra-diabetes.org/     Disclosure: This trial is receiving support from Swedish Orphan Biovitrum AB according to the     Italian law decree 17 December 2004. (B) speaker fees   "
80175|NCT02236468|"     The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food     Production Program implemented by HKI on household food security and nutritional status, as     well as the impact on including additional interventions (BCC on WASH and malaria prevention,     distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24     months old, in addition to the standard E-HFP model.   "
80176|NCT02236455|"     The purpose of this study is to determine the effects of complementary therapies delivered     via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and     self-efficacy in healing reports before, following, and at 10-day follow-up.   "
80177|NCT02236442|"     The purpose of this study is to determine if the use of a therapeutic and global protocol to     relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.   "
80178|NCT02236429|"     Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a     vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is     a high rate of recurrence. Almost half of women successfully treated suffer a recurrence     within three months. Complications include risk factors for premature birth, increased     transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The     investigators proposed study is a cost effective treatment based on returning the normal     microbial balance to the vagina. The investigators propose to transfer normal vaginal flora     from healthy individuals to women with BV and thus restore normal vaginal flora and cure this     disorder.   "
80179|NCT02236416|"     The principal aim of this study is to verify whether a program of supervised, multimodal     physical exercise improves cognitive function and/or reduces the rate of cognitive decline in     older adults   "
80180|NCT02236403|"     Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and     Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin     inflammation, so a intervention that reduces the number of mites and bacteria would be     desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice     in humans and in animals and a single application have show a good response in lice     eradication.      In this study , investigators will determinate the security and effectiveness of this     compound in the eradication of mites   "
80181|NCT02236390|"     The purpose of the proposed pilot study is to extend previous findings regarding the efficacy     of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this     treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive     processing therapy (CPT) (Resick & Schnicke, 1996) is a well-established and efficacious     evidence-based psychological treatment for PTSD in both civilian and veteran populations     (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver,     Astin, & Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the     first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without     the utilization of written exposure (CPT-C) may be more effective than the original protocol.     However, despite such promising evidence, individuals who experience chronic nightmares and     sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment     (Nappi, Drummond, & Hall, 2012). Given that nightmares are considered the hallmark of PTSD     (Ross, Ball, Sullivan, & Caroff, 1989) and their treatment-resistant nature (Davis & Wright,     2007), specific psychological treatments have been developed to target sleep disturbances and     nightmares.      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological     intervention developed to target trauma-related nightmares and sleep disturbances. Though     further evidence is needed, ERRT has exhibited strong support in reducing the frequency and     intensity of nightmares, as well as improving overall sleep quality in both civilian and     veteran samples. In addition, significant decreases in PTSD and depression symptoms have been     reported following treatment (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011;     Swanson, Favorite, Horin, & Arnedt, 2009). ERRT is currently an evidence-level B suggested     treatment (Cranston, Davis, Rhudy, & Favorite, 2011).      There is a call to research suggesting the importance of treatment studies which focus on     interventions that integrate nightmare and sleep symptom treatment with evidence-based     treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to     tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to     CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's     treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances.     Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively     (Bonn-Miller, Babson, Vujanovic, & Feldner, 2010; Hofstetter, Lysaker, & Mayeda, 2005;     Nishith, Resick, & Mueser, 2001). Thus, with improved sleep an individual may have additional     personal coping resources for which s/he can use to address the broader trauma issues (Nappi     et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT     alone.   "
80182|NCT02236377|"     The purpose of this case series dismantling study is to extend previous findings regarding     the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose     effect and mechanism of change.      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological     intervention developed to target trauma-related nightmares and sleep disturbances. ERRT has     exhibited strong support in reducing the frequency and intensity of nightmares, as well as     improving overall sleep quality in both civilian and veteran samples. In addition,     significant decreases in PTSD and depression symptoms have been reported following treatment     (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, &     Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis,     Rhudy, & Favorite, 2011).      Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to     conduct a set of case series in order to examine the possible mechanisms: psycho-education,     dose response for exposure, and no exposure components of the treatment. Each part of the     treatment is theorized to contribute to the improved treatment outcome and it is hypothesized     that participants will benefit no matter what group they are in. All participants will     receive 5 treatment sessions, conducted twice per week for about 90 minutes, of a modified     version of ERRT.   "
80183|NCT02236364|"     Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown     that glucose present in the fluid in the front of the eye, called the aqueous humor,     correlates well with blood glucose. As blood glucose changes, the optical properties of the     aqueous humor change, causing a change in the appearance of the iris of the eye.. The data     collected in this study will be shared with IRISense to assist in validating the algorithm     being used to develop the database needed. The data collected so far is in a narrow band of     the normal glycemic range (healthy volunteers). We will collect standard digital photographic     images of the eyes of subjects with diabetes along with corresponding blood glucose     concentrations using the finger stick glucose monitoring method. In order to do this we will     use standard digital photography techniques that is embedded in our benchtop prototype device   "
80184|NCT02236351|"     This project will assess whether there is a significant difference in compliance with     patching in amblyopic patients whose parents are instructed to pinch the superior and     inferior edges of the patch before applying (in order to improve comfort) versus patients     whose parents are instructed to place the patch evenly around the orbit.   "
80185|NCT02236338|"     The aim of this study is to perform a randomized, prospective trial comparing the two current     methods of treatment for chronic venous insufficiency, in an effort to evaluate complications     and outcomes for each method, and ultimately, to see if one is superior to the other.   "
80186|NCT02236325|"     A significant percentage of individuals who die by suicide do not seek mental health services     in the time preceding their death. This population is underserved and it is unclear what     barriers keep them from seeking treatment. In order to begin a line of research aimed at     addressing this high-risk population, this proposal rests on the hypothesis that suicidal     individuals who do not seek treatment prior to attempting suicide experience the same     psychopathological difficulties as suicidal individuals who do seek treatment - namely,     severe emotion dysregulation. However, these non-treatment-seeker s will likely require more     creative recruitment strategies and briefer interventions than treatment-seeking individuals.     As such, this application proposes to use wide-reaching recruitment efforts throughout the     community to locate and enroll individuals who are suicidal but not seeking treatment.     Further, there is a paucity of empirical support for interventions targeting suicidal     individuals. Dialectical Behavior Therapy (DBT) is one of the few treatments that have been     demonstrated to be effective with a suicidal population and is the only treatment whose     effectiveness has been replicated. Previous research has suggested that an abbreviated     version of the skills that are taught in DBT skills training have effectively reduced emotion     dysregulation (i.e., depression and anxiety) in problem drinkers and the format of the     proposed intervention is derived from this evidence-based emotion dysregulation intervention.     As such, the proposed research is a randomized, controlled pilot trial of a very brief,     one-time, skills-based intervention targeting difficulties in emotion regulation and distress     tolerance.      This research aims to evaluate the safety of the intervention, the feasibility of the     research methods (including the appropriateness of the relaxation training control     condition), and to preliminarily estimate the immediate (one week) and long-term (one and     three month) changes resulting from the DBT Brief Skills Intervention (DBT-BSI) relative to a     relaxation training control on the primary outcomes of suicide ideation and emotion     dysregulation as well as a number of secondary outcomes. These results will inform the design     of a subsequent full-scale randomized controlled trial of the DBT-BSI.   "
80187|NCT02236312|"     The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a     single treatment of three different doses of botulinum toxin compared to placebo, in the     treatment of moderate to very severe glabellar frown lines.   "
80188|NCT02236299|"     The heart requires nutrients and oxygen carried in the blood to generate energy for healthy     pump function. Blood is supplied via heart vessels called coronary arteries. When the     arteries narrow the investigators call this coronary artery disease. Narrowing and blockage     of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in     pump function) and if prolonged even irreversible muscle damage known as a heart attack. The     investigators can treat patients with coronary artery disease with drugs that reduce the     workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed     coronary arteries and improve the blood supply. These treatments can relieve angina, improve     breathlessness and avert heart muscle damage during a heart attack. A potential new     mechanistic effect is emerging by modulating the type of fuel used by the heart to generate     energy more efficiently has been tested in the left ventricle. This study is designed to see     if mechanistic effect provides the same protection in the right ventricle. It is hoped that     this may further improve heart pump function and reduce the size of a heart attack in     patients with coronary artery disease.   "
80189|NCT02236286|"     This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's     disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art,     resting state, functional brain connectivity (Aim II), and determine the number of subjects     needed for a future, randomized clinical trial to test the efficacy of our novel, Agility     Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches     to these aims are cutting edge and will allow us to develop sensitive behavioral and brain     biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.   "
80190|NCT02236273|"     Emerging communication technologies, such as text messaging offer low-cost, scalable     opportunities to improve health literacy and promote healthy behaviors, such as vaccination.     While the investigators reported the success of text message vaccine reminders, effects were     limited by their untailored approach. The trans-theoretical model of behavior change supports     tailoring interventions to an individual's stage of decision-making. Human papillomavirus     (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital     warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious.     Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates.     Limited health literacy regarding the vaccine can affect series completion. The investigators     will compare the effects of enhancing text message vaccination reminders with interactive,     vaccine health literacy-promoting information tailored to vaccine decision making-stage on     HPV vaccine series completion. The effects of these messages represent a new paradigm in     interactive health communications.   "
80191|NCT02236260|"     The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely     demonstrated. The success of this procedure requires that the patient is awake and     cooperative. The conditions of this intervention can be difficult to tolerate by the patient     for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly     the head in the stereotactic frame), stress related to the localization of the DBS. It is     therefore important to improve the comfort as well as the cooperation of the patient, during     implantation of the DBS electrodes, in order to optimize the conditions of the intervention.     In addition to analgesia, acupuncture should allow sedation without affecting alertness and     should contribute to the regulation of any vegetative reactions during the procedure.     Therefore, we hypothesize that acupuncture could improve the quality of care of the patient     during a DBS procedure. In practice, this is electroacupuncture that will be used in this     research to maintain the stimulation of acupuncture points to an optimal level during the     time of the intervention.   "
80192|NCT02236247|"     Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate     control in patients with decompensated heart failure (DHF).   "
80193|NCT02236234|"     Besides the specific response to vaccine antigens, the investigators will analyze the     anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The     hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess     the range of the count with the highest possibility of vaccine response. Thus, knowledge of     vaccine response in HIV-infected patients, indicate which patients would have greater     potential for vaccine response in vivo.   "
80197|NCT02236182|"     Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium     bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG     monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium     bromide as delivered by the RESPIMAT® device when administered over a two-week period.   "
80198|NCT02236169|"     The objective of this study was to determine the pharmacokinetic comparability of 84 µg     ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in     COPD patients   "
80199|NCT02236156|"     A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on     alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in     women with a history of recurrent BV.   "
80200|NCT02236143|"     The primary objective of this study is to develop new ways to acquire MRI data and/or new     ways to analyze the acquired data.   "
80201|NCT02236130|"     Context:      Single shot peripheral nerve blocks have limited duration of action depending on the local     anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need     oral analgesics at home once the block wears off to control the pain.      Objectives:      Primary Objective      To determine if peripheral nerve blocks have any advantage in terms of decreasing oral     analgesic requirements in the post operative period even after the effects of the block have     worn off      Secondary Objective      To determine if inclusion of single shot regional technique improves patient/family     satisfaction with post operative pain management .      Study Design:      Prospective randomized single blinded study.      Inclusion Criteria        -  Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic          surgery with moderate to severe postoperative pain.        -  Surgery of moderate duration (<2hr)        -  Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)        -  American Society of Anesthesiologists (ASA) classification 1 or 2        -  Parents able to understand follow up instructions and are able to reach at home by phone      Exclusion Criteria        -  Known allergy to local anesthetics        -  Preexisting neuropathy with sensory or motor deficits        -  Skin infection at site of needle placement        -  Parents refusal for peripheral nerve blocks   "
80202|NCT02236117|"     The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact,     many studies have been disseminated of heart rate variability in adults, however few results     in a literature this parameters in pediatric population, mainly with children submitted the     physical training. Thus, this Project aims to verify the effects of aerobic training, with 10     weeks, in prepubertal on the performance and heart rate variability in rest.   "
80203|NCT02236104|"     A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve     airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to     confirm the beneficial effects of this treatment in a larger neuromuscular population, to     study its mechanisms of action and to assess whether the effects observed persist over time.     A better knowledge of this treatment should help to define its position in the respiratory     management of neuromuscular patients.   "
80204|NCT02236091|"     The overall aim of this project is to monitor everyday life activity of children with     neurological disorders undergoing rehabilitation using wearable sensors capable of accurate     and unobtrusive long-term measurement.      Specific objectives:        1. To adapt the sensors for the use by children with neurological disorders. The focus lies          on the exact positioning and the investigation of the needed amount of IMUs.        2. To validate the sensor data with collected video recordings and to develop specific          algorithms to automatically extract specific movements and to analyze long-term sensor          recordings.        3. To perform a cross-sectional study to assess intensity, task-specificity and duration of          upper and lower limb activity during rehabilitation. There, we aim to gain objective          information about levels and types of activity during rehabilitation in relation to age,          gender and disorder.        4. To conduct a responsiveness study to assess whether or not the sensor output is able to          highlight changes over time during rehabilitation.      Therefore, at time point T=0 (shortly after admission to our center), participants are     equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum).     Additionally, a small wearable camera is mounted to the chest. The participants then return     to their everyday life for 4 hours (no therapies, measurement period is in the evening).     Afterwards, the equipment is removed again. To investigate responsiveness, the same protocol     is being repeated 4 weeks later (time point T=1).   "
80205|NCT02236078|"     Multidrug-resistant (MDR) tuberculosis (TB) must be treated with second-line drugs (SLD) that     are less effective, more toxic, and more expensive. Treatment requires at least 20 months     with 4 or more effective drugs based on timely drug susceptibility test (DST) results.     However, there are many examples of closely related drugs with differing antimicrobial     activities.      Labs have found differences in DST results among the rifamycins, rifampin (RMP) and rifabutin     (RBT); the fluoroquinolones, ofloxacin and moxifloxacin; and the second-line injectable     agents, kanamycin, amikacin, and capreomycin. In a related finding, isolates resistant to 0.2     mcg/ml INH may be susceptible to higher concentrations. In the Preserving Effective     Tuberculosis Treatment Study (PETTS), 32% of RMP-resistant isolates were susceptible to RBT,     41% of kanamycin-resistant isolates were susceptible to capreomycin, and 45% of isolates     resistant to 0.2 mcg/ml INH were susceptible to 1.0 or 5.0 mcg/ml (1). Other studies have     demonstrated differences in DST results between moxifloxacin and ofloxacin. Whether these in     vitro results translate into clinical efficacy is completely unknown. Given the severely     limited treatment options in MDR TB, it would be exceedingly useful to know whether these in     vitro results translate into evidence for clinically meaningful treatment decisions.      The investigators will determine the clinical bactericidal activity of certain antibiotics     against M. tb that appear to be effective in vitro even though closely related drugs from the     same class are ineffective in vitro. Further, the investigators propose to determine the     molecular genetic determinants of these differences.      Specifically, we plan to determine:        1. The bactericidal activity of RBT in patients whose baseline DST results demonstrate          susceptibility to RBT and resistance to RMP.        2. The bactericidal activity of high-dose INH in patients whose baseline DST results          demonstrate susceptibility to high concentrations of INH and resistance to low          concentrations of INH.        3. The bactericidal activity of RMP when an approved molecular assay demonstrates genetic          mutations associated with RMP resistance, but the phenotypic testing demonstrates          susceptibility to RMP.        4. The bactericidal activity of moxifloxacin in patients whose baseline DST results          demonstrate susceptibility to moxifloxacin and resistance to ofloxacin.        5. The bactericidal activity of amikacin and capreomycin in patients whose baseline DST          results demonstrate susceptibility to either of these two drugs and resistance to          kanamycin.        6. The genetic mutations associated with both in vivo and in vitro drug resistance and          bactericidal activity.      To achieve these objectives the investigators propose an innovative variation on early     bactericidal activity (EBA) study methodology. Patients at risk for MDR TB will be screened     for RMP resistance and INH resistance using molecular assays. In those with RMP-resistant or     INH-resistant TB, the investigators will quickly perform phenotypic DSTs using the direct     method in the Bactec Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will     be available within 14-21 days. If the DST results show, for example, RMP resistance but     susceptibility to RBT, consenting patients will be treated with RBT by itself for 10 days.     The investigators will assess its effect with serial quantitative sputum cultures. If the     concentration of viable bacteria decreases significantly, the investigators will interpret     this to mean the drug is having an effect. If not, the drug is ineffective. After 10 days,     the patients will resume individualized multidrug treatment based on the full set of DST     results.      In case the investigators identify drugs that are effective under these conditions, the     investigators will sequence known and putative genes associated with the action of these     drugs for the mycobacterial isolates from these patients.      The results would have immediate implications for treatment of MDR TB and for diagnostic     mycobacteriology.   "
80206|NCT02236065|"     This open label trial is conducted to investigate the efficacy and safety of the combination     therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor     (G-CSF) for patients with brain injury or neurodegenerative disorders.   "
80207|NCT02236052|"     This is a multiple sites phase II trial, randomized, observer-blind, dose ranging,     placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single     intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine     administered in elderly subjects (50 years old and more).      A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75     subjects to receive one injection of either a non-adjuvanted low, medium or high dose level     of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined     with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate buffer     + 150 mM sodium chloride (NaCl) + 0.01% Tween 80)   "
86167|NCT02158169|"     The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha     biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to     concomitant iron supplementation.   "
80208|NCT02236039|"     The investigators are investigating the effects of traffic-related diesel exhaust on lung     function and the immune system in those at risk for COPD. The individual will be exposed to     either filtered air (FA) or carefully controlled levels of diesel exhaust (DE) in our     exposure chamber. Post exposure the individual will complete a steady state exercise test.     24h later, a procedure called bronchoscopy (whereby a thin, flexible tube is placed down the     throat and into the lungs) will be used so that samples can be collected from the lungs.     After 1 month the entire procedure will be repeated with the alternative exposure.   "
80209|NCT02236026|"     The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an     bolus injection on the corrected QT interval using Fridericia's formula (QTcF).   "
80210|NCT02236013|"     The purpose of this study is to describe the dose limiting toxicities (DLT) and define the     maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin remission     induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This     study will also characterize the pharmacokinetics (PK) of ASP2215 when given in combination     with cytarabine/idarubicin remission induction and high-dose cytarabine (HiDAC) consolidation     therapy in newly diagnosed acute myeloid leukemia as well as evaluate the effect of ASP2215     on the PK of cytarabine.   "
80211|NCT02236000|"     This study is being done for the following reasons:        -  The study has two parts. The purpose of the first part (Phase I) of the study is to find          out the highest dose of neratinib that can be given safely with T-DM1.        -  The purpose of the second part of the study (Phase II) is to find out whether the dose          of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse          for a period of time.        -  In order to learn more about study therapy levels in blood and discover genetic and          protein changes associated with cancer, the study includes special research tests using          samples from blood and from breast tumor. Blood samples will be collected before study          treatment, once during treatment, and after study treatment stops.        -  In the optional part of this study, three biopsies will be performed to obtain fresh          tumor samples from an area where your cancer has spread.   "
80212|NCT02235987|"     The study is designed to investigate the safety, tolerability and efficacy of DG3173 in     untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and     one dose of octreotide, the current gold standard of medical therapy for acromegaly, with     each patient receiving all doses of DG3173 as well as octreotide.   "
80213|NCT02235974|"     To perform an exploratory single center randomized study that will form the basis for a     larger scale, more definitive randomized clinical trial to determine the optimal time after     stroke for intensive motor training. The investigators will perform a prospective exploratory     study of upper extremity (UE) motor training delivered at higher than usual intensity at     three different time points after stroke:        -  early (initiated within 30 days)        -  subacute/outpatient (initiated within 2-3 months)        -  chronic (initiated within 6-9 months)      The control group will not receive the therapy intervention during the 1-year study.      Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and     one year after stroke onset.      Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or     chronic (6-9 months after stroke onset) time points, participants randomized to early     intensive motor training will show greater upper extremity motor improvement measured at one     year post stroke.   "
80214|NCT02235961|"     This trial is conducted in the United States of America (USA). The aim of the trial is to     investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the     body) for single doses of NNC9204-0530 alone and in combination with liraglutide in     overweight to obese but otherwise healthy male subjects.   "
80215|NCT02235948|"     The purpose of this study is to determine whether folic acid supplementation are effective on     arsenic lowering in a chronic, low-level arsenic exposed population.   "
80216|NCT02235935|"     Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non     proliferative DR and proliferative DR. The damage is caused by either macular edema, macular     ischemia that can be followed by vascular proliferation.      Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in     the tissues and has been proven to be beneficial in treating different wounds in diabetic     patients but its effect hasn't been tested in diabetic retinopathy yet.      This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due     to different indications such as chronic wounds or radiation damages and who also have     diabetic retinopathy. These patients will undergo opthalmic physical examination including     fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography).     Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe     Medical Center for all diabetic patients prior to their first treatment.   "
80217|NCT02235922|"     The purpose of this study is to analyze the effects of a dual task protocol on cognitive     domains and functional capacity in non-sedentary older adults.      The hypothesis of the present study is that older people undergoing to a dual task exercise     protocol have greater benefits on cognition and functional performance, compared to a     standard exercise protocol.   "
80218|NCT02235909|"     The purpose of the study is to evaluate the efficacy and safety of the study drug relative to     an active comparator losartan which the same class of drug and is approved for use in the     pediatric population aged 6 years and older. Approximately 260 subjects will participate in a     6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind,     randomized placebo-controlled withdrawal phase. This study also includes a 44-week,     open-label extension (OL Phase) in which all subjects will receive AZM and other     antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood     pressure will be assessed in the clinic throughout the study, and subjects may also     participate in a 24-hour ambulatory blood pressure monitoring (ABPM) procedure at baseline,     at the end of the DB Phase and at the end of the OL Phase.   "
80289|NCT02234986|"     The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a     safe and effective treatment in patients with FLC. Safety will be measured by looking at the     adverse events that may happen and the efficacy will look at the progression of the disease     over time.   "
80230|NCT02235753|"     Despite the well-known health benefits of physical exercise in the prevention of chronic     diseases, less attention has been focused on the use of physical exercise as an essential     part of good treatment for chronic disease. The aims of the study are to investigate the     feasibility, medical effects, cost-effectiveness, and social perspectives of the     individualized exercise-based rehabilitation [2 different high-intensity training (HIT)     protocols combined with usual care (UC)] after acute coronary artery disease (CAD) event. The     medical aim is to study mediating mechanisms of the physiological, biochemical and molecular     effects of exercise training on the clinical outcomes. The aim of the health-economic     evaluation is to assess the changes in the Health-Related Quality of Life (HRQL) and health     care related costs for estimating the cost-effectiveness of HIT-based exercise     rehabilitation. The purpose of the sociological analysis is to find out the social processes     which make possible the emergence of the desired welfare effects.   "
80219|NCT02235896|"     The ultimate goal of our partnership with local African-American churches is to implement an     effective, multi-component intervention to increase awareness of the critical importance of     healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the     American Heart Association (AHA) prevention strategy, &quot;Life's Simple 7&quot; to address     the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes,     cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy     consists of a community-based participatory research approach that involves focus groups to     assess participant knowledge and beliefs about CVD risk factors prior to program initiation.     We will also determine participant dietary and exercise practices, knowledge and perceptions     related to healthy lifestyle and chronic diseases, demographic/health status information,     health care utilization, biometrics (weight, blood pressure, blood tests for glucose and     cholesterol, etc.) and attitudes about medical research at baseline, program completion and     6-month follow-up.   "
80220|NCT02235883|"     The objective of the HEART Study is to develop a multiscale model of the coronary circulation     based on multimodal imaging data (angiography, echocardiography). The predictive     comprehensive multi-scale model, developed during this proof-of-concept study, will be used     for analyzing functional aspects of coronary artery disease. Model validation is performed     against invasive measurements   "
80221|NCT02235870|"     This pivotal trial of the Obalon Balloon System is intended to generate safety and     effectiveness data required to support a future marketing application. The trial has been     designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition     and lifestyle behavior modification program.      Weight loss will be evaluated after the 6-month course to determine if a specific predefined     superiority margin can be achieved in the device group compared to a sham-control group.   "
80222|NCT02235857|"     Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant     lipoproteins including low density lipoprotein from circulating blood flow and rapidly     reduces the plasma cholesterol level. The system was originally developed for the treatment     of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied     to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring     about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g,     proteinuria and hypoproteinemia).      Although the definitive mechanism by which the system may relieve nephrotic syndrome is     unknown, it has been recognized as one of alternative therapies for refractory nephrotic     syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the     Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of     Nephrology.      This study is conducted as a post approval study imposed by Humanitarian Device Exemption     (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the     treatment of drug-resistant pediatric primary FSGS.   "
80223|NCT02235844|"     This research study is designed to evaluate the effects of human umbilical cord mesenchymal     stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle     regenerative and anti-inflammatory properties of UC MSCs position them as a possible     treatment option for DMD. Both of these properties could lead to potential benefits for a DMD     patient.   "
80224|NCT02235831|"     The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort     Plus® (DACP) MF contact lens using new objective measurements.   "
80225|NCT02235818|"     The purpose of this study was to compare the immediate efficacy of Counterforce brace versus     kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a     repetitive physical task. The investigators hypothesized that there would be difference in     the outcomes with respect to interventions and activity. Patient came for one hour long     Single occasion testing session and were not followed up after the testing was complete.   "
80226|NCT02235805|"     Observational epidemiologic studies have observed an inverse relationship between daily     dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also     beneficially affect other cardiovascular risk markers. Whether all these effects translate     into improved vascular function is not known. Different vascular function markers at various     stages on the pathway between diet and disease exist. One of these markers, vascular     stiffness, is closely related to the process of atherosclerosis, an independent     cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To     examine the integrated effects of interventions on cardiovascular risk, vascular stiffness     may therefore serve as a marker at the later stage of cardiovascular disease development.      Therefore, it is imperative to examine in a 24-week, randomized, double-blind,     placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium     on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold     standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary     excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time     courses of an increased magnesium intake on changes in BP, other markers reflecting vascular     function, and plasma biomarkers related to low-grade inflammation and vascular activity will     be measured to unravel possible cause-effect relationships.   "
80227|NCT02235792|"     This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as     pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson     disease. Newly developed technology allows for the chronic recording of these brain signals     at the same time as clinical stimulation is occuring. We will learn both whether these HFO     correlate with disease activity and whether the HFO change in response to ongoing stimulation     (potentially giving insight into the underlying mechanism of action of DBS).   "
80228|NCT02235779|"     Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies     done via bronchoscopy in the investigation of interstitial lung disease in comparison with     videothoracoscopy-assisted surgical lung biopsy.   "
80229|NCT02235766|"     Purpose of the observational study is to assess the capability of a satellite     tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips     to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality.     Additionally the prognostic efficacy of specific echo parameters in the cardiac     resynchronization therapy response will be evaluated.   "
80231|NCT02235740|"     This open-label, 2-part Phase I/ randomized Phase II multi-center study is conducted to     evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of     afuresertib in combination with carfilzomib versus carfilzomib alone, in subjects with     relapsed/refractory MM. Part 1 will evaluate 2 dose levels (125 milligrams [mg] and 150 mg of     afuresertib) in 16 subjects (approximately 8 in each parallel arm) to determine an optimal     dose of afuresertib for administration in combination with carfilzomib in Part 2. If neither     of these dose levels are tolerated, an additional dose level of 100mg of afursertib in     combination with carfilzomib may be explored in approximately 8 additional subjects. Part 2     was to investigate the safety, and clinical activity of the combination of afuresertib with     carfilzomib (determined in Part 1) compared to carfilzomib alone, in approximately 100     subjects (50 in each parallel arm), however the study was terminated after the     discontinuation of the single subject following the transition of the afuresertib development     program from GSK to Novartis. The reason for the study termination is that the protocol     defined study treatment was no longer aligned with the evolving standard of care.   "
80232|NCT02235727|"     A Single Dose Study of GBR 900 in Healthy Volunteers.   "
80233|NCT02235714|"     The purpose of this study is to obtain markers of airway inflammation from the exhaled breath     condensate (the moisture in exhaled air) for comparison to blood based markers. These markers     will be compared in tetraplegic, asthmatic and able-bodied control groups. Additionally, lung     function testing will be performed, and the associations between breath condensate and blood     markers and pulmonary function explored between groups.   "
80234|NCT02235701|"     This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with     ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.   "
80235|NCT02235688|"     This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus     gemcitabine in Subjects with solid tumors.   "
80236|NCT02235675|"     Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating     tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from     1.5mm to 4.5mm.   "
80237|NCT02235662|"     The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR),     TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate     pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate     acceptability of the IVRs.   "
80238|NCT02235649|"     Reduced social and community functioning is a predominant and enduring feature in people     experiencing severe mental illness such as psychosis. The large majority of interventions     (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and     delusions) but poorly address functional and social consequences of the illness.      This study attempts to fill this gap by assessing the feasibility and acceptability of a     psychological intervention targeting social cognition deficit in people with psychosis. The     intervention is a group psychological treatment facilitated by a clinical psychologist     targeting competencies such as emotion recognition, social situation appraisal and guessing     people's intentions and mental states. The group therapy takes advantage of audiovisual     material to illustrate strategies and thinking styles that may help participants to overcome     difficulties in social settings.      A second objective of this study is to test a new method to measure social cognition. Recent     research showed that interview and performance based tests are poorly associated with every     day activity of people with schizophrenia. This study is planning to evaluate the feasibility     of new assessment methods for social cognition in everyday life using portable electronic     devices (Experience Sampling Method and an activity watch). These devices will be carried by     participants in their everyday life and will ask about feelings and levels of social     activities at random times and record basic physiological and activity levels.   "
80239|NCT02235636|"     To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and     conventional Laparoscopic surgical suturing among novice   "
80240|NCT02235623|"     This is a randomized trial designed to evaluate testicular outcomes after a single stage     versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in     the abdomen. Also to determine and compare the costs, surgical complications and the health     related quality of life for the two procedures. Testicular outcomes will be measured using a     scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for     those randomized to a 2 stage surgery).   "
80241|NCT02235610|"     The overall objective of this study is to evaluate the clinical effectiveness of the novel     technique of donor EVLP in increasing lung transplant activity by allowing previously     unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to     utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory     molecules (biomarkers) that would benefit a successful pre-conditioning and increase     knowledge of the lungs inflammatory response before transplantation.   "
80242|NCT02235597|"     The investigators seek to improve health systems so underserved people, patients without     insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access     health care for common problems and acute care needs (same day appointments).   "
80243|NCT02235584|"     In this study we examine whether inducing insulin resistance by dexamethasone in healthy     volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.   "
80260|NCT02235363|"     In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars     with desired results. Especially to improve the jowls and nasolabial folds, the thread lift     is a simple and inexpensive technique for patients who do not wish to undergo the typical     facelift surgery, but the weak points of it are less effective and shorter duration than the     conventional facelift.The investigators propose the new method of the thread lifting the     subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments     with two fixation points on both temporal fascia and retaining ligaments.   "
80590|NCT02231047|"     The purpose of this study is to compare the occurrence of childhood diarrheal disease and     pneumonia in subjects under the age of 5 years in low resource settings who have received     prophylactic 64N nutraceutical (64N)as a neonate as compared with neonates who have not     received prophylactic 64N.   "
80244|NCT02235571|"     The investigators developed iChoose Kidney -- a shared decision-making support tool     accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers     with a simple, standardized, easily accessible, statistically robust tool for use in the     clinic to guide patient education and healthcare decision-making about treatment options of     dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with     estimates of their individualized 1 and 3-year risks of mortality on dialysis vs.     transplantation, based on previous national data. The tool has the potential to improve     communication and decision-making between patients and their healthcare providers and improve     access to kidney transplantation among patients with ESRD.      This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers     with diverse patient populations. One group of patients will receive standard education alone     during their scheduled transplant evaluation. The second group will receive the standard     education as well have the provider use the iChoose Kidney aid with them. The project     timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and     outcome evaluation.      This study will assess how well the iChoose decision aid works in improving patient     knowledge, preferences for treatment, and patient access to transplant. The study will also     assess whether providers find the tool useful for providing ways to share information with     patients about ways to treat their kidney disease.   "
80245|NCT02235558|"     The purpose of this study is to determine whether super-selective intra-arterial     administration of verapamil immediately following successful intra-arterial thrombolysis is     safe as a potential neuroprotective agent. Standard procedures are cerebral angiography and     intra-arterial thrombolysis (intra-arterial administration of tPA and/or mechanical     thrombectomy). Experimental procedure is superselective injection of verapamil     intra-arterially.   "
80246|NCT02235545|"     The purpose of this post approval study is to characterize the chronic performance of the SJM     Optisure family of HV leads in patients.   "
80247|NCT02235532|"     This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and     gingivitis.      The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and     10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided     into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out     period was allowed and then subjects used fluoride toothpaste for the next 30 days . This     order was reversed in group 2.   "
80248|NCT02235519|"     The goal of this study is to build a mathematical model to explain the effect of two doses of     azilsartan (40 and 80 mg) upon metabolic (insulin resistance, glucose) and inflammatory     parameters (cytokines) in function of metabolic strata like obesity, type 2 diabetes     mellitus, hypertension and their combinations.   "
80249|NCT02235506|"     The investigators compared continuous epidural infusion with combined continuous femoral and     single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and     secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation     indices.   "
80250|NCT02235493|"     The purpose of this study is to characterize the natural history of HPP in patients with     Juvenile-onset HPP who served as historical controls in ENB-006-09.   "
80251|NCT02235480|"     The aim of this study is to determine the efficacy and safety of topical application of the     gel compared to placebo in nail psoriasis.   "
80252|NCT02235467|"     This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis     (ABA) parent training using video modeling to teach parents of children with Autism     techniques to apply to their children in order to improve eye contact and joint attention     behaviors.      Our hypothesis is that children with Autism whose parents will be trained by videomodeling     will have better eye contact and joint attention behaviors compared to children with Autism     whose parents will not be trained.   "
80253|NCT02235454|"     The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for     spectral domain optical coherence tomography (SDOCT) and if this software is superior to the     conventional one that is currently used for SDOCT.   "
80254|NCT02235441|"     There is growing evidence of the integral role of exercise following cancer treatment.     Randomized trials show that exercise improves post treatment symptoms and quality of life in     breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause     mortality for patients with breast, prostate, brain or colorectal cancer. Nearly a 40-50%     relative risk reduction in cancer specific death and 20-50% relative risk reduction in all     cause mortality have been reported with exercise. At present it is unknown if preclinical     pleiotropic effects on tumors through aerobic exercise are clinically relevant. Before     launching into further studies of exercise training on changes in tumor hypoxia and response     to CRT in rectal cancer patients, it is first important to understand: 1. Whether measures of     exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are     associated with markers of tumor hypoxia at diagnosis (prior to initiation of CRT) and 2.     Whether changes in measures of exercise exposure over the course of CRT are related to     changes in tumor hypoxia and response to CRT.   "
80255|NCT02235428|"     To determine whether addition of ipratropium bromide to salbutamol nebulisations produces     significantly greater bronchodilation in young children presenting to an emergency department     with an acute attack of asthma   "
80256|NCT02235415|"     Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential     hypertension. To obtain information on the dosage used in practice and the tolerance at the     start of treatment (12 weeks)   "
80257|NCT02235402|"     The aim of this study is to compare the effects of lacidipine on markers of platelet     activation and other rheological factors in hypertensive patients with those of     bendrofluazide   "
80258|NCT02235389|"     The general aim of this study was to assess the feasibility of treating acute myocardial     infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase     (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition     by paramedics   "
80259|NCT02235376|"     Identification of criteria associated with extubation failure of brain injured patients.     Elaboration of a prognostic score of extubation failure of brain injured patients.   "
80261|NCT02235350|"     Epidemiological studies report that 85% of stroke survivors show hemiparesis and a percentage     ranging from 55% to 75% report upper limb functional impairment. Early rehabilitation in     stroke patients with motor disorders can be effective to restore the affected function and to     improve the performance of daily activities. Up to now, different methods and techniques have     been used to recover motor functions in stroke patients. However, none of these has been     conclusively proven to be more effective than the others. The clinical benefits induced by     motor rehabilitation are closely related to neuroplasticity. The main aim of the present     study is to assess the efficacy of action observation treatment, based on Mirror Neuron     System (MNS), in the rehabilitation of upper limb motor functions in acute stroke patients.     The study will also aim at assessing neuroplasticity within areas belonging to the MNS     through functional magnetic resonance (fMRI).   "
80262|NCT02235337|"     The purpose of this study is to investigate the effectiveness of riboflavin to decrease the     duration of time for a student-athlete to return to participation in sports after a sports     related concussion.   "
80263|NCT02235324|"     This phase II trial studies how long it takes colorectal cancer resistant to standard     treatment to grow while receiving treatment with ziv-aflibercept, and how well adding     fluorouracil and leucovorin calcium to ziv-aflibercept works in treating patients with stage     IV colorectal cancer after they progress on ziv-aflibercept alone. Ziv-aflibercept may stop     the growth of colorectal cancer by blocking the formation of tumor blood vessels.     Fluorouracil and leucovorin calcium are drugs used in chemotherapy. Fluorouracil works to     stop the growth of tumors cells by preventing the cells from growing and dividing. Leucovorin     calcium helps fluorouracil work better. Adding fluorouracil and leucovorin calcium to     ziv-aflibercept may be an effective treatment for patients who progress on ziv-aflibercept     alone.   "
80264|NCT02235311|"     Despite recommendations from clinical practice guidelines to discharge patients from the     hospital on once daily proton pump inhibitors after acute management of UGIB, clinical     practice is to use twice daily proton pump inhibitor therapy. The objective of this study     will be to assess whether or not once daily pantoprazole is non-inferior to twice daily     pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump     inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe     for any potential difference in safety for once daily versus twice daily proton pump     inhibitors.   "
80265|NCT02235298|"     Dapagliflozin is a new and emerging anti-diabetes medication. Dapagliflozin is a selective     sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with type     2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is a     consistent associated finding. Because dapagliflozin increases urinary glucose excretion,     weight loss could result from reduced body fat secondary to caloric loss or from fluid loss     secondary to osmotic diuresis or from a combination of both factors. Nevertheless, whether     Dapaglifozin may cause a reduction in visceral fat is unknown.      Hence, in this study the investigators would like to test the hypothesis that Dapaglifozin     causes a rapid and significant reduction of the epicardial fat, the visceral fat of the     heart, in type 2 diabetic patients.      This hypothesis would be tested in a prospective interventional study in 100 overweight or     obese type 2 diabetes subjects.   "
80266|NCT02235285|"     In 162 Asian patients, primary breast augmentations were performed by a single surgeon during     5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation     using single antibiotic breast irrigation by a single surgeon's practice and examines the     comparison of Asian and Western outcomes in primary breast augmentation.   "
80267|NCT02235272|"     The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)     compared to vehicle in the treatment of subjects with inflammation and pain following     cataract surgery.   "
80268|NCT02235259|"     The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic     Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4     week Three Times a Day (TID) treatment period   "
80269|NCT02235246|"     Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer or     premalignant lesions in the stomach. ESD enables en bloc resection of gastrointestinal     neoplasms, increases the rates of histologically complete resections, and also reduces local     recurrence rates. Despite these advantages, ESD is thought to induce various complications.     Wellknown ESD-related complications include perforation, postoperative bleeding, or     stricture. In addition, minor adverse events after ESD are also commonly noticed. Pain is one     of these frequently noticed minor ESD related complications, is the main reason for     prolongation of the hospital stay, and is related to patients' compliance; however, there is     a tendency to neglect or underestimate post-ESD pain. The causes of pain associated with ESD     are thought to be associated with transmural burn or transmural air leak. Some studies have     tried to control localized pain during and after ESD using local lidocaine, single dose     postoperative intravenous dexamethasone or a transdermal fentanyl patch. Magnesium has been     reported to alter the perception and duration of pain and produce important analgesic     effects. It is included the suppression of neuropathic pain, potentiation of morphine     analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet     fully understood, the analgesic properties of magnesium are believed to stem from regulation     of calcium influx into the cell and antagonism of N-methyl-D-aspartate receptors in the     central nervous system. Also, magnesium may prolong neuromuscular blockade after     administration of neuromuscular blocking drugs, increase sedation and contribute to serious     cardiac morbidity. And magnesium as a hypotensive anaesthesia technique supply objectively     better operative field, reduction in the duration of surgery and reduced blood loss. There     have been no previous trials on the use of magnesium specifically for pain control following     ESD. Thus, the purpose of this study was to assess the efficacy of intravenous magnesium for     pain relief after ESD.   "
80270|NCT02235233|"     This study is designed to investigate the effect of NASH (non-alcoholic steatohepatitis) on     the disposition of 99mTechnetium(Tc)-mebrofenin and to relate changes in 99mTc-mebrofenin     disposition to differences in the bile acid profile and Fibroscan Fibrosis Score of healthy     subjects compared to patients with NASH.   "
80271|NCT02235220|"     In this study it is to be evaluated wether a restoration with composite resin fillings to     reestablish a canine guidance will reduce masticatory muscle activity in patients with     bruxism.   "
80272|NCT02235207|"     The purpose of the study is to investigate the effectiveness of Fustra® exercise program in     relieving recurrent pain in the neck or/and back, and thus improve quality of life in female     and male office workers. The hypothesis is that neuromuscular exercise will improve control     of posture and movement, neck shoulder and trunk flexibility, trunk muscular endurance and     leg strength, and thus decrease intensity of pain by 30% compared to non-exercise group. In     addition, financial feasibility of the exercise program and effects of training on quality of     life and perceived work ability are studied.   "
80273|NCT02235194|"     It has previously been shown in healthy overweight subjects, that table water including a     defined amount of amino acids and chromium can decrease the postprandial glucose and insulin     response. In this study, the effect of this table water on glucose excursions after a test     meal containing a defined amount of available carbohydrates, protein and fat will be studied     in patients with early type 2 diabetes or prediabetes according to guidelines that are     treated with dietary measures or metformin only. The study will be conducted in a cross -over     design, double blinded and placebo controlled including 20 participants. The primary endpoint     of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180     minutes after ingestion of the meal.   "
80274|NCT02235181|"     This study aims to determine whether the Arabin cervical pessary prevents preterm birth in     women with a twin pregnancy and a short cervix.   "
80275|NCT02235168|"     To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.   "
80276|NCT02235155|"     The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol     medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.   "
80277|NCT02235142|"     Open study to make a comparison between hypogonadism and euogonadism patients regarding the     severity of prostate cancer. The purpose of this study is to determine the importance of the     relationship between the hormonal status and the type of the tumor at the time of surgical     intervention as well as follow up of the patients.   "
80278|NCT02235129|"     To compare the relationship between breath-hold time and the distance in a Six Minute Walking     Test in chronic obstructive pulmonary disease population.   "
80279|NCT02235116|"     This is a cross-sectional survey distributed to a convenience sample of patients in a waiting     room of an academic dermatology clinic. The survey assesses patient experiences with full     body skin exams and attitudes towards full body skin exams. The survey is designed to help     investigators better understand how many patients are not getting full body skin exams, why     this may be occurring, and what types of interventions may be enacted to increase the number     of patients getting full body skin exams.   "
80280|NCT02235103|"     Recent research has revealed that subtle abnormalities can be found in sperm samples that     seem to be normal with conventional analysis techniques. The DNA in the sperm heads is     sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained     infertility do not achieve pregnancy.      We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples     with previously unexplained infertility. In a first treatment cycle with intra-uterine     insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the     results of the patients who are pregnant will be compared with those of the not pregnant     ones. We expect to find differences between both groups.      100 patients will be included in the study.   "
80281|NCT02235090|"     Clinical trials organization in several neuromuscular disorders (NMD) has some specific     issues. Nonambulant status and difficulties with transportation are among them. Moreover a     lot of patients with NMD have so poor condition that even short transportation is able to     worse it. Such situation forces researchers to limit a region of recruitment for clinical     trials and to exclude from trials more severe subgroup of patients, which cause additional     issues especially for rare diseases.      The purpose of this study is to prove hypothesis about possibility to reliably monitor     patient condition remotely, without trial site visiting. Visit-free study design is     potentially able to widen eligible patient population and to decrease patient dropout rate as     well as burden of numerous assessments. Meanwhile assessment frequency could be increased     enabling monitoring of short fluctuations in patients' condition.      Spinal muscular atrophy (SMA) is a rare neuromuscular condition to which all mentioned above     issues are completely applicable. Direct current stimulation (DCS) of neural structures is     well studied and safe intervention, however, its effects on SMA patients' strength and     durability has not been reported for today. The investigators suppose that investigation of     DCS action in SMA patient population is an adequate model for visit-free design feasibility,     reliability and sensitivity evaluation.   "
80282|NCT02235077|"     The primary objective of this study is to test the hypothesis that high-dose spironolactone     will lead to greater proportional reduction in NT-proBNP levels from randomization to 96     hours over standard of care.   "
80283|NCT02235064|"     The purpose of this project is to assess the effectiveness of preventative antidepressants     immediately following delivery on postpartum depression rates in women at high risk due to     prior history of depression or postpartum depression.   "
80284|NCT02235051|"     This randomized pilot trial studies how well an exercise intervention works in preventing     breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise     may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to     respond to inflammation more proficiently, helping to prevent primary and recurrent breast     cancer.   "
80285|NCT02235038|"     This study will evaluate a potential physiologic mechanism underlying the effects of dietary     composition on control of body weight   "
80286|NCT02235025|"     The current definition of chronic obstructive pulmonary disease (COPD) is based on the     presence of persistent airflow obstruction assessed by spirometry. About half of the subjects     with mild COPD (i.e. reduced forced expiratory volume in one second (FEV1) on forced vital     capacity (FVC) ratio along with normal FEV1] are asymptomatic. Subjects with symptomatic mild     COPD have reduced exercise tolerance and abnormal dynamic ventilatory mechanics compared to     healthy subjects. The physiological and perceptual responses to exercise of subjects with     asymptomatic mild COPD are currently unknown.      The purpose of this study is to assess exercise tolerance, ventilatory constraints on tidal     volume expansion and dyspnoea in asymptomatic mild COPD subjects undergoing incremental cycle     cardiopulmonary exercise testing (CPET) to the limit of tolerance compared with symptomatic     mild COPD and healthy controls.   "
80319|NCT02234583|"     This is an open-label study of DS-5565 in subjects who either completed participation in a     preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309, DS5565-A-E310,     or DS5565-A-E311 or are de novo subjects. Eligible subjects will be assigned to receive     open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for     the first three weeks of the treatment period. After three weeks, subjects may be titrated to     15 mg twice daily (BID) based on protocol-specified criteria.   "
80290|NCT02234973|"     Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health     outcomes compared to the general population because of a wide array of factors: social     determinants of health, lifestyle, genetic susceptibility, and historic-political and     psycho-social factors. Barriers to care that are unique to First Nations communities     exacerbate the problem with fragmented healthcare, poor chronic disease management,     healthcare staff turnover, and limited, or non-existent, surveillance.      Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research     program aims to develop and evaluate community-driven, culturally relevant, primary     healthcare models that enhance chronic disease prevention and management in First Nations     communities in Canada. Participants will consist of Indigenous community and clinic team     members that will take part in multiple interrelated projects including community profiling,     readiness consultations, diabetes registry and surveillance, and quality improvement     workshops and action periods.      Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical     process and outcomes measures, 2) details about community-driven innovations, and 3)     knowledge about the experience and cost of attempting to improve primary delivery in     individual Indigenous communities.      Intervention/Instrument: Survey, literature review, 15 month intervention (readiness     consultations, implementation and maintenance of a registry and surveillance system,     community and clinic focused quality improvement workshops), interviews.      Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline);     Secondary-clinical process and outcome measures, change in stage of readiness, description of     participation and innovation facilitators and barriers.      Policy Implications: The outcomes of this research program have the potential to     significantly affect future policy decisions pertaining to chronic disease care in First     Nations communities. Policy recommendations will be made to help support Indigenous     communities in adopting successful innovations to help address issues related to diabetes and     other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the     subsequent policy decisions may enhance chronic disease prevention and management for     Indigenous peoples across the country.   "
80291|NCT02234960|"     The aim of this non-interventional, prospective, observational study is to assess the     effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic     treatment in participants with moderate to severe active RA who are inadequate responders to     disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs,     in a routine clinical practice setting in Poland. The length of the entire study will be 24     months.   "
80292|NCT02234947|"     Type 1 diabetes (T1D) is characterized by a progressive destruction of insulin producing beta     cells, resulting in a lifelong dependence on exogenous insulin. While beta cells make up less     than 1% of the pancreas, studies have demonstrated that T1D is associated with a marked     reduction of pancreatic mass at diagnosis and as the disease progresses. As such, if     pancreatic volume assessment, by ultrasonography (US) or MRI (Magnetic Resonance Imaging),     could be utilized as a marker of beta cell function in high risk patients, non-invasive     pancreatic imaging could become an important part of staging diabetes risk. As such, the     primary goal of this study is to measure pancreatic volume and compare differences in volume     between new onset T1D patients, antibody positive subjects at risk for diabetes, antibody     negative individuals, and healthy controls.   "
80293|NCT02234934|"     Chronic Granulomatous Disease (CGD) is an inherited immunodeficiency disorder which results     from defects that prevent white blood cells from effectively killing bacteria, fungi and     other microorganisms. Chronic granulomatous inflammation may compromise vital organs and     account for additional morbidity. CGD is thought to affect approximately 1 in 200,000     persons, although the real incidence might be higher due to under-diagnosis of milder     phenotypes.      The first gene therapy approaches in X-CGD have shown that effective gene therapy requires     bone-marrow (BM) conditioning with chemotherapy to make space for the gene-modified cells to     engraft. These studies demonstrated that transplantation of gene modified stem cells led to     production of white blood cells that could clear existing infections. However, some trails     using mouse-derived retroviral vectors were complicated by the development of myelodysplasia     and leukemia-like growth of blood cells. This trial will evaluate a new lentiviral vector     that may be able to correct the defect, but have much lower risk for the complication.      This study is a prospective non-controlled, non-randomized Phase I/II clinical trial to     assess the safety, feasibility and efficacy of cellular gene therapy in patients with chronic     granulomatous disease using transplantation of autologous bone marrow CD34+ cells transduced     ex vivo by the G1XCGD lentiviral vector containing the human CGD gene. Primary objectives     include evaluation of safety and evaluation of efficacy by biochemical and functional     reconstitution in progeny of engrafted cells and stability at 12 months. Secondary objectives     include evaluation of clinical efficacy, longitudinal evaluation of clinical effect in terms     of augmented immunity against bacterial and fungal infection, transduction of CD34+     hematopoietic cells from X-CGD patients by ex vivo lentivirus-mediated gene transfer, and     evaluation of engraftment kinetics and stability. Approximately 3-5 patients will be treated     per site with a goal of 10 total patients to be treated with G1XCGD lentiviral vector.   "
80294|NCT02234921|"     This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.   "
80295|NCT02234908|"     This pilot project is an evaluation of the feasibility, acceptability, and cost of offering     an economic reward, in the form of a shopping voucher, to the household contacts of index     patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the     study clinic for TB screening and optional HIV testing, providing a reward to the index     patients for participating, and entering index patients whose contacts do present into a     lottery to win a prize.The effectiveness of the intervention in screening a high proportion     of contacts will be compared to existing published data from studies of active case-finding     through home visits and of the status quo passive case finding. If successful, this pilot     project will create a demand for screening among high risk patients, who will be rewarded for     identifying themselves to the healthcare system, and could prove to be an affordable     alternative to resource-intensive home visits. It will also shift responsibility for contact     tracing from overburdened clinic staff to those who have the most to gain from early case     detection—the patients and their families.   "
80296|NCT02234895|"     Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of     life and increased economic burden. Current research has focused on expensive, invasive     treatments, whereas inexpensive conservative treatments have received less attention. One     such treatment is the use of orthotics to reduce pain and increase function in people with     knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and     contradictory, and could benefit from more research taking into account foot posture. This     study aims to compare the use of two orthotics designs in people with knee OA.   "
80297|NCT02234882|"     The purpose of this study is to assess the effect of the coadministration of multiple doses     of BMS-663068 on the systemic exposure of rosuvastatin.   "
80307|NCT02234739|"     voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis,     however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis     secondary to COPD is not clear. This study aims to investigate the effectiveness and     tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in     Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of     aspergillus, improvement of chest imaging as well as record of possible adverse reactions     following 2-week intravenous instillation of voriconazole.   "
80460|NCT02232750|"     The investigators hypothesize that CPD parameters will provide improved prediction of sepsis     compared to currently employed laboratory parameters. These studies hold the potential to     shape practitioner guidelines and improve the timeliness and accuracy with which patients     with sepsis are treated today.   "
80298|NCT02234869|"     The primary objective of the study is to evaluate, in participants with RMS, safety and     tolerability (as defined by the frequency of adverse events [AEs] of flu-like symptoms [FLS;     chills, pyrexia, myalgia, and asthenia], injection site reactions [ISRs], and injection site     reaction pain [ISR-P]) over 6 months of treatment (the active comparator period) with BIIB017     125 μg subcutaneously (SC) every 2 weeks versus standard-of-care SC interferon-beta (IFN-β)     therapy. Secondary objectives of this study are to assess the following measures during the     first (6-month) period of the study in participants treated with BIIB017 versus     standard-of-care SC IFN-β therapy: patient-reported treatment satisfaction using the     following patient-reported outcome measures (PROMs): Treatment Satisfaction Questionnaire for     Medication (TSQM-9), Adapted MS Treatment Concerns Questionnaire (MSTCQ), Adapted MSTCQ Side     Effects Score, Pain using a visual analog scale (VAS) diary and the McGill Pain Questionnaire     Short Form (SF-MPQ), the treatments' impact on RMS using the following PROMs: Multiple     Sclerosis Impact Scale (MSIS-29), Modified Fatigue Impact Scale-5 Item (MFIS-5), EuroQol     Group 5-Dimension 3-Level Version (EQ-5D-3L), Health-Related Productivity Questionnaire     (HRPQ), Beck Depression Inventory, second edition (BDI-II), participant adherence to study     treatment, clinical status as measured by the Expanded Disability Status Scale (EDSS) and     relapse activity, safety and tolerability of study treatment after a change in     standard-of-care SC IFN-β therapy and the immunogenicity profiles of participants changing     from standard-of-care SC IFN-β to BIIB017.   "
80299|NCT02234856|"     This study aims to test the validity of a new educational tool in the form of a computer     based video surgical simulator, that may be used to enhance the current teaching method of     how to perform a hysterectomy.   "
80300|NCT02234843|"     The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to     standard of care in children with acute venous thromboembolism.   "
80301|NCT02234830|"     Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence     of adverse access site related events at 30 days.   "
80302|NCT02234804|"     Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated,     academic superiority trial comparing optical coherence tomography (OCT) guided vs.     angiography guided wire recrossing in jailed side branches (SB) (1. randomization     1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut     apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and     30 days clinical follow-up.      Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed     struts in the segment facing the SB ostium.      Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less     malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime     stent.   "
80303|NCT02234791|"     X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected     patients have very low levels of peripheral B cells and a profound deficiency of all     immunoglobulin isotypes. Mutations in the gene encoding for Bruton's tyrosine kinase (Btk)     are responsible for most of the gammaglobulinemia.      We tend to investigate the gene mutation and clinical features of Chinese X-linked     agammaglobulinemia (XLA) patients, and also examined the relationship between specific Btk     gene mutations and severity of clinical presentation.   "
80304|NCT02234778|"     The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis®     Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device     removes certain cells from the adipose (fat) tissue which will be used to treat patients with     blockages in the arteries of their lower legs that may require a future amputation, which is     caused by severe peripheral artery disease (PAD). The purpose of this study is to determine     if treatment with cells that have been removed from the Icellator System™ device will reduce     the number of major amputations and deaths in a six month time period.   "
80305|NCT02234765|"     Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive     sleepiness secondary to repeated obstruction of the upper airway during sleep and     cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders.     Epidemiological studies in our country have shown that OSA is a highly prevalent disease in     the general population, affecting 2-4% of the adult population. The most important clinical     manifestations of OSAS is a deterioration in the quality of life and an increase in     cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and     considering the medical complications of OSA, as well as the sociolaboral impact and its     negative impact on quality of life and survival; is stated that this disease is a public     health problem that requires the physician to identify patients eligible to treatment.     Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health     resources, comparing when the diagnosis and treatment has been established. Finally, we have     a highly effective treatment using positive pressure in the upper airway (CPAP) that has been     shown to be effective and cost-effective. The current situation in which all patients     diagnosed with OSA and receiving different treatments are monitored and controlled by the     Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our     working hypothesis is: By the coordination of actions at various levels including     interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records     and the use of new technologies can be achieved in AP satisfactory management of the     diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both     areas have a level of clinical response, satisfaction, compliance and avoidance of     complications, similar to that obtained with monitoring by SU. In addition, management by AP     will be more cost-effective than in the SU.   "
80306|NCT02234752|"     Aim: To examine the efficacy of the combination of galantamine and memantine for the     treatment of cognitive deficits in outpatients with schizophrenia.      Hypothesis: A combination of galantamine and memantine will improve cognitive impairments in     patients with schizophrenia.      This is an open-label study to evaluate whether a six week course of galantamine ER and     memantine XR is effective in improving the cognitive performance of patients with     schizophrenia or schizoaffective disorder. The primary outcome measure will be the change in     level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). The results     of the MATRICS collaborative project recommended the need for standardized cognitive tests     that better distinguish the different facets of cognitive dysfunction in schizophrenia. The     MCCB will assess the following seven domains: attention/vigilance, reasoning and problem     solving, processing speed, social cognition, verbal learning and memory, visual learning and     memory, and working memory. The MCCB will be administered at baseline and at the end of the     study. We will report total score and each domain score in the MCCB at baseline and six     weeks.   "
80425|NCT02233205|"     Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the     therapeutic effects. The main purpose is to identify the safety of combining ultrasonic     microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from     alimentary system and pancreatic carcinoma.   "
80308|NCT02234726|"     The purpose of this study is to evaluate the impact of a community-based early childhood     development (ECD) program on children's physical and cognitive development. Under the     program, targeted communities will be assigned a trained Child Development Agent (CDA) who     will have four main tasks and responsibilities: 1) biweekly screening and management     (including referral) of acute malnutrition in children; 2) encouragement of caregivers to     utilize routine care services for children; 3) screening for symptoms of acute diseases     including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4)     organization and mentoring of biweekly caregiver meetings to discuss parenting and promote     early childhood cognitive stimulation. The investigators will enroll at baseline around 600     children ages 6 - 12 months and their caregivers, and randomize them at the community-level     to receive the ECD program or to remain in the control group. The study period will be one     year. At end line, the investigators will collect important indicators of child physical and     cognitive development to assess program impact. If the program shows both feasibility and     impact, there is the potential to integrate program interventions into existing national     community-based health initiatives.      Amendment: the study period has been extended for a second year. After a five month gap when     no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups     were restarted in intervention clusters. In the second year of the intervention, CDAs no     longer visit households.   "
80309|NCT02234713|"     Disease modifying therapies (DMT) are widely used for children and adolescents with MS.     Nonetheless, many pediatric patients continue to relapse and therefore require changes in     therapy. We designed this research study to learn more about medication use in children and     adolescents with MS. We are also interested in learning what a behavioral feedback     intervention can tell us about adherence to medicine. Finally, we hope this research project     will inform the way we provide clinical care for children and adolescents with MS.   "
80310|NCT02234700|"     Comparison between patients with nasolacrimal duct obstruction and healthy patients and the     influence of their bacterial flora on the corneal epithelium.   "
80311|NCT02234687|"     In this study, we propose to employ a randomized, double-blind, placebo-controlled,     outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40     mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating     fear-potentiated startle response and behavior in adults with post-traumatic stress disorder     (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg     vs placebo in a 1:1:1 ratio).   "
80312|NCT02234674|"     This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a     leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).      This study is a pilot controlled randomized study with two arms.   "
80313|NCT02234661|"     The CAP Family Advancement Study (CAP FAST) is a randomized control trial of CareerAdvance®,     a dual-generation program providing education, career coaching, and soft-skills training for     parents while their children attend CAP Tulsa's Head Start programs.   "
80314|NCT02234648|"     Given the global health issues associated with poor cardiovascular function, interventions     that help reduce the severity, with emphasis on prevention would not only have economic     implications, but would also improve health, wellbeing and quality of life. Research provides     evidence that consumption of a diet high in plant foods and rich is polyphenols is associated     with a reduction in the incidence of cardiovascular disease (Hung et al 2004). Tart     Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al 1999;     Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve blood     vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012), reducing     vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et al 2006)     and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of the lining     of blood vessels (endothelial dysfunction) has been linked to increased risk of     cardiovascular disease. However, the bioavailability of all the compounds in Tart Montmorency     Cherry Juice and their efficacy with respect to vascular function has not been fully     determined. This study will examine the influence of tart Montmorency cherry juice on     cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood     flow in the microcirculation by laser Doppler imaging. This study will also examine digital     volume pulse and pulse wave analysis. These data will provide information on the ability of     TMCJ to affect blood flow and vascular function.   "
80315|NCT02234635|"     In this study, the investigators examined the subjective visual quality including LogMAR     uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity     (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate     visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual     acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including     Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS     value (OV),and the tear-film quality dynamics including the tear break-up time and the     tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality     analysis system (OQAS).   "
80316|NCT02234622|"     Given the limited effectiveness of current treatments and the burden PTSD places on Veterans     and clinicians, this research aims to compare the effects of a standardized, traditional,     holistic yoga intervention (postures, breathing, deep muscle contraction and relaxation     practices) with a wellness program (wellness topics and physical activity) on PTSD symptoms.   "
80317|NCT02234609|"     Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment in     many developing countries. Because, ART is intended to be operated in molars, and about 10%     of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was the     aim of this study to clinically evaluate a modified ART restoration technique for anterior     teeth as the traditional treatment approach did not show satisfying clinical results.   "
80318|NCT02234596|"     This is a phase II study of Nintedanib in patients with metastatic or recurrent     esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an     orally available triple kinase inhibitor targeting the receptors of the vascular endothelial     growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor     (FGF) receptor pathways.   "
86847|NCT02149290|"     This study will evaluate the accuracy of data on body position, daily activity, heart rate,     6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator     (WCD).   "
80320|NCT02234570|"     The objectives of the Phase I study are to evaluate the safety and tolerance of increasing     single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the     pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The     description of agent used is single oral dose of an aqueous suspension of oxfendazole, a     benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two     week safety data for the preceding group have been reviewed. If a clinically significant AE     is observed, and if this event is drug-related the safety monitoring committee will be     convened to determine whether the study should continue.   "
80321|NCT02234557|"     Attention Deficit Hyperactivity Disorder (ADHD) has tremendous individual and societal     impact, and the effectiveness of current standard treatments is limited. We examine a novel     treatment that could remediate the core features of ADHD and thereby contribute to sustained     improvements in behavioral control. This approach is motivated by mounting evidence that     children with ADHD show difficulties with motor control, and that these motor deficits are     strongly associated with the core behavioral features of ADHD. We employ Tai Chi, targeting     improvements in well-established behavioral and physiologic measures of motor control, and     with this, improvements in ADHD symptoms. The proposed study offers immense potential for the     development of novel therapeutic approaches for ADHD with little risk of adverse reaction.      The over-arching goal of this proposal is to examine a movement-based mindfulness training as     a therapeutic intervention for children with ADHD. This approach is motivated by two     complimentary lines of evidence: 1) Children with ADHD show impairments in motor control that     parallel (and correlate with) core deficits in behavioral control that define the disorder.     2) Gains in cognitive and behavioral control have been observed in adults learning Tai Chi,     dance, or meditation. These lines of evidence provide substantial motivation for our proposed     investigation of movement-based mindfulness training in children with ADHD. Specifically, we     propose to evaluate an established Tai Chi-based intervention. We chose this approach for a     number of reasons: 1) Tai Chi is among the most well-established movement-based interventions     with documented therapeutic effects, including cognitive effects. 2) While many     movement-based approaches show evidence of yielding cognitive improvements Tai Chi provides     excellent opportunities for engagement of 8-12 year old children in the form of the     collaborative game push hands. 3) Tai Chi instruction consists of gentle movements that can     be practiced even by those with physical limitations, and is readily available in the United     States so the protocols developed in this study will be straightforward to deploy at a     national level.      Hypothesis: After participating in a Tai Chi program, children with ADHD will show     improvements in behavioral and physiologic measures of motor control. We further expect     movement-based training will result in decreases in ADHD symptom severity.   "
80322|NCT02234544|"     Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a     single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.      Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe     compared to cholecalciferol plus placebo.   "
80323|NCT02234531|"     The aim of the project is to assess whether the continuous visualization of on-line teacher     in virtual reality (VR) is effective for the improvement of upper limb motor function, in     stroke patients.   "
80324|NCT02234518|"     Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the     major contributors to GI discomfort is constipation, which has a prevalence of ~15% and     symptoms of which have a significant negative impact on the sufferer's quality of life. One     of the hallmarks of chronic constipation is slow progression of contents through the gut     (i.e. slow gut / colonic transit time), which may be associated with hard stools that are     difficult to expel.      Dietary fiber supplements are widely used as a first-line treatment for constipation although     little Level 1 evidence exists to support its use in adults. The effectiveness of different     fiber supplements is difficult to compare given wide differences in water-retention     capabilities and effects on the colonic microbial ecology. Given the promising, yet largely     unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation,     the objective of this clinical trial is to evaluate tolerance and effectiveness of four week     supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and     gastrointestinal symptoms in adults with functional constipation.   "
80325|NCT02234505|"     In human gait there is a certain amount of variation between steps; some considered     physiological and owed to variations in environment or posture, and some severe enough to be     indicative of gait instabilities that may lead to stumbling and falling. In users of lower     limb prosthetics, such gait instabilities are of especially great interest.      The study investigates the correlation between socket alignment quality and gait step-by-step     variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined     range of step-by-step variability exists, and that therefore step-by-step variability is     suitable as an outcome variable for the assessment of socket alignment.      A sample of ten persons with trans-tibial amputation will be recruited for this pilot study.     Subjects will be asked to walk on different natural surfaces while the socket alignment is     successively perturbed. Step-by-step variations in horizontal ground reaction forces and     torsional moments will be measured and statistically compared.   "
80326|NCT02234492|"     The purpose of this study is to determine whether the use of rosuvastatin in Human     Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels,     improves blood circulation in the small arteries that provide nutrients to the heart muscle     and improves neurocognitive function.   "
80327|NCT02234479|"     The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation     dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It     is hoped that the outcome of this pilot study will provide evidence supporting the use of     Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary     data to expand this study to larger, federally funded research (R01) looking at the     beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in     several disease settings.   "
80328|NCT02234466|"     Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the     improvement of quality of recovery from surgery. The study population is limited to breast     surgery patients. The investigators will also look at the effect of our intervention on post     operative nausea and vomiting.      Patients will be recruited before the date of their surgery and will complete the Quality of     Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will     also complete a Clinically significant nausea and vomiting score upon discharge from the post     anesthesia recovery room, repeated at 24 hours post op.   "
87228|NCT02144337|"     This study aims to test the feasibility of a physical activity intervention called the Steps     To Active Kids (STAK) programme in children aged 9 - 11 years with Type 1 Diabetes Mellitus     (T1DM).   "
80469|NCT02232633|"     This is an open label, multi-center, phase II study of BBI503 administered to adult patients     with advanced hepatobiliary cancer who have exhausted all currently approved standard     anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous     28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no     longer clinically benefiting from therapy.      Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study     treatment.   "
80329|NCT02234453|"     The investigators hypothesise that cancer patients on systemic anticancer therapy can measure     a home blood count, temperature, record qualitative data and transfer the results     electronically to the hospital clinical team.      A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic     anti-cancer therapy (SACT) and can be life-threatening when complicated by sepsis. Neutrophil     count is usually obtained by venepuncture by a health-care professional. The Minicare H-2000     is a new device which facilitates home self-testing of blood count, temperature and symptoms.     The four components are i) blood count recorder using a capillary sample obtained via     finger-prick ii) Bluetooth linked thermometer iii) tele-hub collecting patient-reported     outcomes and iv) secure communication through the 3G network.      The investigators propose a single-centre, non-randomised feasibility study to test the     process of patients on chemotherapy using the Minicare H-2000 to deliver self-tested blood     count readings, temperature and qualitative data electronically to the hospital clinical     team. The aim is to test training of patients to use a finger-prick method of obtaining blood     count, patient ability to perform the test, retention of training, the ability of the     Minicare H-2000 to facilitate the data transfer and to test the secondary care interface.     This study will provide preliminary data on the potential of Minicare H-2000 to prevent     wasted hospital journeys when the blood count has not recovered sufficiently for subsequent     SACT cycles. The investigators intend to obtain informed consent to recruit between 30 to 80     patients to this study which will be performed in addition to current local standard of care.      This study enables identification of suboptimal areas of the process prior to investigating     the application of the minicare H-2000 within oncology to improve the clinical patient     pathway. The investigators ongoing intentions are to trial the use of the Minicare H-2000 to     reduce frequency and severity of neutropenic complications, prevent wasted hospital journeys     and hospital resources, reduce non-elective hospital admissions and personalise delivery of     SACT.   "
80330|NCT02234440|"     In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis),     coming to ILBS (Institute of Liver & Biliary Sciences) OPD (Out patient Department) or     getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria     and consent of the patient. These patients will be randomised to either metformin arm or     conventional treatment arm. After enrollment these subjects will be monitored every three     monthly for total of 12 months or till the primary endpoint is achieved. At the end of the     study, outcome will be measured appropriately.   "
80331|NCT02234427|"     This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene     expression in persons at high-risk of developing heart attacks due to family history of     early-onset coronary artery disease   "
80332|NCT02234414|"     In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown     and the published data from the Swiss hospitals statistics represent only the tip of the     iceberg. In addition, the percentages of women correctly identified with vertebral fractures     due to osteoporosis and the treatment rate of these women with a drug proven to reduce the     risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of     vertebral fractures differs between urban and rural areas or between mountain areas and plain     country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in     physical activity and/ or dietary habits.      Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either     sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a     combination of both would improve sensitivity and specificity is unknown.      The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and     lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a     retrospective study of hospitalized elderly patients has shown that as many as 50% of the     radiographic reports failed to note the presence of moderate to severe vertebral fractures.     In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or     vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment     was offered to only 36% of the diagnosed patients.      The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA     measurements allows for the detection of vertebral deformities, which is critical for     management of osteoporosis, as the existence of such deformities substantially increases the     risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of     a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to     expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between     90-94%.   "
80333|NCT02234401|"     Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years     (UK CF Registry 2011). The commonest cause of death is respiratory failure.      Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the     size and depth of each breath. It is introduced in CF to manage established respiratory     failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation,     is used just at night, or for part of the day in addition or for 24 hours as clinical status     indicates. It is introduced within a normal ward environment and then continued longterm at     home.Once respiratory failure is established longterm noninvasive ventilation is introduced     throughout 24 hours and multidisciplinary assessment concludes that the timing is appropriate     for the individual.      This study aims to evaluate a potential development of current practice: the use of non     invasive ventilation during hospital admission only to enhance recovery from an acute     exacerbation which has caused respiratory failure in those individuals where long term non     invasive ventilation is not yet indicated. A mixed methods design will allow description of     the experience of noninvasive ventilation during a semistructured interview to add to     understanding of the results from an experiment designed to measure the differences between     noninvasive ventilation and standard care.      Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an     acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.   "
80334|NCT02234388|"     This registry has been established to gain a better understanding of the clinical and     emotional presentations of patients with undifferentiated connective tissue disease.   "
80335|NCT02234375|"     The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who     have a contraindication to iodine based contrast. These patients normally get investigated     with studies such as ultrasound and nuclear medicine studies but the fastest and preferred     investigation is CT with contrast to look for filling defects in the pulmonary arteries. The     investigators will assess whether gadolinium, which is currently used with MRI can be used     with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of     CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium     contrast on CT.   "
80336|NCT02234362|"     The broad goal of this study was to examine the efficacy and tolerability of vortioxetine     (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women     around the menopausal transition. We hypothesized that an eight-week treatment with     vortioxetine would promote a significant improvement of depression symptoms and other     menopause-related physical symptoms.   "
80359|NCT02234063|"     In this genomic medicine implementation pilot project, the investigators aim to conduct a     randomized trial in a network of community health centers and primary care facilities to     study processes, effects and challenges of incorporating information for apolipoprotein L1     (APOL1)-attributable genetic risk for end stage kidney disease in patients of African     ancestry with hypertension .   "
80536|NCT02231762|"     The purpose of the study is to evaluate the efficacy and tolerability of the combination of     Lanreotide Autogel 120 mg and Temozolomide in patients with progressive     gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All     progressive tumours classified according to Response Evaluation Criteria In Solid Tumours     (RECIST, 1.1).   "
80337|NCT02234349|"     Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic patients     with chronic kidney disease and improves patients' outcome. However, in spite of an optimized     systemic insulin substitution, altered glucose metabolism and beta cell function are reported     in these patients. The mechanisms behind these abnormalities are still unclear.     Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could     change physical and chemical properties of intestinal secretions, gut flora, as well as     intestinal permeability. The effect of this procedure on gut derived metabolic factors, the     enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been     studied. This pilot prospective, study is aimed to evaluate the modification of bile acids     concentrations and composition in PKT subjects, and the impact in glucose and incretin     metabolism (measured by oral glucose tolerance test) one year after transplantation. The     results will be compared to those of kidney transplant patients and control subjects.   "
80338|NCT02234336|"     Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and     prognostic importance given its known association with sudden cardiac death. However, data     regarding comparison of imaging modalities for this key measurement is lacking. This study     seeks to compare assessment of maximum wall thickness between clinically indicated     echocardiography (with and without contrast) and clinically indicated cardiac magnetic     resonance imaging.   "
80339|NCT02234323|"     The primary objective of the study is to evaluate the safety of rFVIIIFc (BIIB031) in     previously untreated participants with severe hemophilia A. The secondary objectives are to     evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in     previously untreated patients (PUPs), to evaluate rFVIIIFc consumption for the prevention and     treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc     for immune tolerance induction (ITI) in participants with inhibitors.   "
80340|NCT02234310|"     The primary objective of the study is to evaluate the safety of rFIXFc (recombinant     coagulation factor IX Fc fusion protein, BIIB029) in previously untreated participants with     severe hemophilia B. Secondary objectives are to evaluate the efficacy of rFIXFc in the     prevention and treatment of bleeding episodes in previously untreated participants (PUPs),     and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in     previously untreated participants.   "
80341|NCT02234297|"     Many types of cancer are primarily treated with surgery and patient survival is directly     related to the extent to which the tumor is able to be removed. It is often difficult for     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have     spread from the original tumor site, resulting in incomplete removal of the tumor and reduced     patient survival. In some sites, such as the brain, it is critical to avoid damage to normal     tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize     that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of     the tumor and small groups of cancer cells that have spread to other sites in real-time as     operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas     undergoing surgery.   "
80342|NCT02234284|"     This proposed study will examine whether health coaches can improve the management of COPD in     a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed     as a randomized controlled trial for patients with moderate to severe COPD. Patients will be     randomized into a health coaching group and a usual care group. Those in the health coaching     group will receive 9 months of active health coaching. Outcome variables will be measured at     baseline and after 9 months   "
80343|NCT02234271|"     The primary objective of the investigators study was to design a comprehensive and medically     accurate contraception counseling mobile health application and evaluate the effects of this     contraception counseling application on the contraceptive methods that patients selected and     their knowledge of that method.   "
80344|NCT02234258|"     Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses     that incur substantial suffering for patients and major challenges to the investigators     health care and legal systems. The prodrome is the period prior to onset of psychosis when     functional decline and clinical symptoms gradually emerge. The presence of a clinical     high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the     later development of psychosis, and for those who do not necessarily go on to develop a     psychotic illness, research has suggested that the majority continue to have fluctuating     subthreshold symptoms and poor social and role functioning. There are no specific treatments     to help with these functional difficulties. However, recent findings suggest that in people     with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to     significantly greater increase in the frequency of social functioning activities compared to     treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is     a feasible treatment for CHR. This proposal is a competitive application for a three-site,     longitudinal study aimed at testing the effectiveness and feasibility as well as mediators     and mechanisms of action of a manualized CBSST intervention that will target functional     difficulties associated with clinical risk states for psychosis. The goals are 1) to examine     whether CBSST compared to a placebo intervention (psychoeducation) matched for group     involvement and therapist time improves functioning in youth at CHR and 2) to determine     whether reduction in defeatist beliefs and improvement in social competence mediate change in     psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm     trial participants will be randomized to one of two treatments: CBSST, an 18-week group     comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or     a psychoeducation support group that does not teach active cognitive behavioral therapy or     social skills training. Over a five-year period, the multi-site collaboration will follow     large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral     changes, to examine changes in social and role functioning, as well as symptom changes from     baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate     the feasibility of a treatment for which it is easy to train therapists and which can readily     be disseminated to regular clinical community practice. In addition, it will provide insights     into likely approaches to halting or mitigating the pathological process and advance the     investigators understanding of risk prediction; both critical steps in prevention.   "
80345|NCT02234245|"     The purpose of this research is to estimate the outcomes in health and cost of the follow-up     of patients with pacemakers.      The initial hypothesize of this study is that remote monitoring of pacemaker will show a best     relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.   "
80346|NCT02234232|"     The primary aim of this pilot study is to evaluate the feasibility and safety of four     different types of intradialytic exercise (exercise performed during dialysis) programs:     resistance, aerobic, combined resistance and aerobic, and flexibility (attention control).     The secondary aim of the study is to estimate the effect of aerobic and resistance exercise,     each compared with the attention control on: health-related quality of life, tests of     physical performance, strength, and physical activity outside of the dialysis unit. The     results of this study will be used to inform the planning of a full-scale efficacy study.   "
80347|NCT02234219|"     Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.   "
80348|NCT02234206|"     This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in     40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25     ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum     verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium     fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed,     Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum,     Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna     prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit,     Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera     sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in     India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and     morphology. Secondary Outcome measure is to see the impact on the harmone level.   "
80349|NCT02234193|"     The investigators are doing this research study to learn about how the skin heals after many     microscopic skin biopsies are collected.      Skin-grafting is a life-saving procedure for people with large area skin wounds caused by     burns or trauma. Conventional autologous (self) skin grafting techniques require the creation     of large donor site wounds, causing numerous complications including pain, infection,     blistering, discoloration, and scarring. Based on previous research, many of these adverse     effects can be improved, or even eliminated, by harvesting skin tissue in very small     biopsies. These micro-biopsies are less than the size of a sewing pin. Then, they are put     back together into a skin graft.      This concept is based on clinical observations from fractional photothermolysis laser     therapy, an FDA approved laser that has been previously developed by the investigators     research group for the treatment of scars and ageing skin. With this laser technique,     thousands to millions of small burns are produced by laser on a patient's skin, and the skin     responds by healing the damaged areas to create new healthy skin within days and without     scarring.      Although the results of laser treatment are well-known, it is not known what happens when we     harvest the skin using needles instead of using the laser to cut the skin. The investigators     also would like to understand how the body heals the skin. Understanding how this works helps     in understanding wound healing, and may lead to future treatments for healing large wounds,     disfiguring burn scars, and preventing scar formation.      A tummy tuck (abdominoplasty surgery) is done to remove excessive skin of the belly. This is     an elective surgery, in other words, it is optional and usually done for cosmetics reasons     (to improve the appearance).      The skin of the belly that is removed during an abdominoplasty surgery (tummy tuck) is     discarded. The skin of the area removed is called pre-abdominoplasty skin. The     investigators would like to study the effects of the micro-biopsies on pre-abdominoplasty     skin to exam how the skin heals over time and to study the skin that will be removed during     the abdominoplasty surgery.      This is a pilot study. Pilot studies are done on a small group of subjects to learn if a     larger study would be useful.      The investigators are asking subjects to take part in this study who are healthy with an     abdominoplasty surgery (tummy tuck) scheduled at Massachusetts General Hospital (MGH) by a     plastic surgeon .      The investigators will enroll about 28 subjects in this research study, all at MGH.      The Department of Defense is paying for this study to be done.   "
80350|NCT02234180|"     This randomized phase II trial studies how well regorafenib works in treating patients with     cancer of the esophagus or gastroesophageal junction that has spread from where it started to     nearby tissue or lymph nodes and have completed chemoradiation therapy and surgery.     Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
80351|NCT02234167|"     The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was     called The Social Medicine Remand Prison Project is to target injecting drug users (IDU)     with primary and secondary health interventions with regards to injecting and sexual risk     behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted     infections (STI).      The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk     behaviour and disease outcome among IDUs over time.   "
80352|NCT02234154|"     This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for     lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.   "
80353|NCT02234141|"     This study will compare the efficacy, safety, and tolerability of three doses of selonsertib     (GS-4997) to placebo in adults with pulmonary arterial hypertension (PAH). The study will     consist of a 24-week placebo-controlled treatment period and a long-term selonsertib     treatment period. Participants completing the 24-week placebo-controlled period will be     eligible to receive active treatment with selonsertib in the long-term treatment period.   "
80355|NCT02234115|"     The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of     subjects with advanced prostate carcinoma, when administered as two injections six months     apart.   "
80356|NCT02234102|"     The study aims to compare the results of pulmonary vein isolation (PVI) with a single     technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with     patients who have persistent AF of less than 3 months. Many studies have shown that     electrical reconnection of the pulmonary veins following the index procedure can occur in up     to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation     utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and     effective and has also shown promising rates of durable isolation compared to point by point     radio frequency techniques. However, the impact of employing this technique for patients with     persistent AF has not yet been reported. The study hypothesis is that there will be no     statistically significant difference between the results of PVI in the two groups of     patients.   "
80357|NCT02234089|"     The purpose of this study is to detect factors influencing decision making for treatment     pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving     medicinal androgen deprivation therapy (Degarelix or LHRH agonists).   "
80358|NCT02234076|"     Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with     posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent     Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which     psychotherapy is widely practiced. Depression is one of the most common co morbid disorders     when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event     often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and     depression have been related to a reduced specificity in autobiographical memory.      Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET)     in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will     also attempt to develop protocols to implement this new technology into clinical practice and     collect data to develop a treatment progress prediction model.      Study design: A randomized controlled intervention study.      Study population: 144 individuals with memories of CSA or war related trauma and symptoms of     PTSD and/or depression.      Intervention: VRET or TAU.   "
80537|NCT02231749|"     The purpose of this study is to compare the objective response rate, progression free     survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib     monotherapy in patients with previously untreated Renal Cell Cancer.   "
80361|NCT02234037|"     STUDY BACKGROUND AND PURPOSE:      Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more     common with increasing age. AML is harder to treat in older patients, with typically poor     responses to standard chemotherapy.      Patients with AML are typically given intensive induction chemotherapy, but many older     patients cannot tolerate the side effects of this therapy. Decitabine has been shown to be     active and better tolerated in frail patients with AML; however, most patients still relapse.      Recent studies suggest that improving the performance status and fitness of older AML     patients prior to induction chemotherapy may help to lessen side effects.      This study will test the combination of decitabine treatment with physical exercise in     elderly patients with AML who are not candidates for standard induction chemotherapy.      STUDY DESCRIPTION:      This is a pilot study to test the combination of decitabine treatment with an 8-week physical     exercise program in AML patients ≥ 60 years of age who are not candidates for standard     induction chemotherapy. Patients who are eligible to take part must give their written     agreement before they can be enrolled.      This study will enroll 20 patients who are not candidates for standard induction     chemotherapy. Patients will begin an 8-week program of physical exercise, including 2-3     sessions per week supervised by a physical therapist. During this 8-week period, patients     will be given 2 cycles of decitabine therapy (daily infusion for 5 consecutive days of a     28-day cycle).      Patients will be followed to assess the safety and tolerability of the program. Patients will     also give blood samples that will be used to assess their response to treatment. Patients     will be evaluated for their physical fitness before and after the 8-week exercise program and     will complete questionnaires to assess their quality of life before and after the program.   "
80362|NCT02234024|"     The purpose of this pilot project is to see if a supplemental form of dietary gangliosides     can serve as a potential treatment for the rare metabolic condition called ganglioside GM3     synthase deficiency.   "
80363|NCT02234011|"     This study is being done to learn whether administration of intranasal (inhaled through the     nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been     approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to     reduce pain during surgery and other procedures) but ketamine has not been approved by the     FDA as a treatment for OCD.      The investigators believe that ketamine may be effective in reducing symptoms of OCD due to     its ability to decrease the activity of a specific brain chemical called glutamate. Previous     studies have shown that people with OCD can have abnormal levels of glutamate in their     brains. This is the first time that intranasal ketamine is being studied in people with OCD.     However, studies have been done in the past using intravenous (IV; through a needle into a     vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in     people with other psychiatric conditions.      This research study will compare ketamine to placebo. The placebo looks exactly like     ketamine, but contains no ketamine. At some time during the study, the investigators will     give you ketamine. At another time, the investigators will give you placebo. Placebos are     used in research studies to see if the results are due to the study drug or due to other     reasons.   "
80364|NCT02233998|"     The reduction of existing plaque and gum inflammation will be evaluated using two marketed     mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth     rinse.      165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to     be in this study will have an equal chance of being assigned to one of the three treatment     groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2)     Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain     a diary at home to record each treatment use and will be asked to come to the clinic without     brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations     for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at     Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.   "
80365|NCT02233985|"     - Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to     severe bronchiolitis.   "
80366|NCT02233972|"     This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the     purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection     to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic     parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.   "
80367|NCT02233959|"     Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone     to pediatric and adult patients. The rationale for this study is that palatability is the     most important determinant of pediatric patient compliance, and therefore, it is critical     that the Orbis formulation be perceived as significantly more palatable compared to today's     commercially available products in order to warrant further development of the TP.   "
80368|NCT02233946|"     The purpose of this study is to assess the psychometric properties of a brief screening     questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians'     offices, and to pilot test a personalized, computer-facilitated brief intervention delivered     on a tablet computer and by the provider based on screening results.   "
80369|NCT02233933|"     Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and     Hemospray in the therapy of bleeding from Radiation Proctitis   "
80370|NCT02233920|"     Study to obtain further information on the tolerability and efficacy of Ventilat®     metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of     daily practice   "
80371|NCT02233907|"     Study to obtain further information on the tolerability and efficacy of Ventilat® metered     dose inhaler in long-term treatment of Chronic Obstructive Pulmonary Disease under conditions     of daily practice   "
80372|NCT02233894|"     Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in     the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice   "
80373|NCT02233881|"     Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in     the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice   "
80409|NCT02233413|"     The purpose of this research study is to find out if a specialized helmet that provides low     levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on     the recovery of people who have recently (within 72h) suffered a moderate traumatic brain     injury (TBI).   "
80421|NCT02233257|"     X-linked adrenoleukodystrophy (ALD) is a genetic disorder affecting the brain and adrenal     glands. Approximately one third of boys who are at risk will develop cerebral disease. Using     a specific diet and the compound Lorenzo's oil, it can be shown that very long chain fatty     acids may be lowered in the blood, but it is not known to what degree that may prevent the     onset of childhood disease.      This proposal makes available Lorenzo's oil to individuals with ALD, a life threatening     disorder for which there are presently no other therapies.   "
80538|NCT02231736|"     The purpose of the study is to determine whether glycemic control (HbA1c) is linked to     chromosomal damage in type 2 Diabetes patients   "
80374|NCT02233868|"     Background:      - Brain inflammation due to high alcohol intake may affect thinking, memory, and     concentration. Researchers want to measure this using positron emission tomography (PET).      Objective:      - To study how excessive alcohol consumption affects brain function.      Eligibility:        -  Adults 30-75 years old who are moderate or severe alcohol drinkers.        -  Healthy volunteers.      Design:        -  Participants will be screened with medical history, physical exam, interview, and blood          and urine tests. Their breath will be tested for alcohol and recent smoking.        -  Phase 1:        -  Participants will stay in the hospital 3 days. They will have blood and heart tests and          daily urine tests.        -  A small plastic tube will be inserted by needle in each arm. One will go in a vein, the          other in an artery.        -  Participants will have 2 PET scans with 2 different radioactive compounds. Participants          will lie on a bed that slides in and out of the scanner with a cap on their head.        -  Participants will have magnetic resonance imaging (MRI) scans. Participants will lie in          the scanner either resting with their eyes open or while performing an attention task.        -  Participants will have tests of memory, attention, concentration, and thinking. They may          answer questions, take tests, and perform simple actions.        -  Phase 2 of the study will only be done if Phase 1 results show brain inflammation.        -  Phase 2 will repeat Phase 1.        -  For healthy volunteers, Phase 2 will begin 3 weeks after Phase 1.        -  Other volunteers must not have alcohol for at least 3 weeks and stay in a hospital up to          4-6 weeks between Phase 1 and Phase 2. After Phase 2, they will have 5 follow-up calls          over 3 months.   "
80375|NCT02233855|"     Background:      - Neurocysticercosis (NCC) is caused by tapeworms that infect people. NCC can lead to serious     brain problems such as seizures, sevre headaches and difficulties with movements or sensation     in the limbs. Researchers want to learn more about the different ways in which people in the     United States present with this disease and how they respond to standard and newer     treatments.      Objective:      - To learn about the different forms of NCC that occurs throughout North America and how     patients with these forms respond to treatment.      Eligibility:      - Adults age 18 or older with NCC.      Design:        -  Participants will be screened with:        -  Medical history and physical exam.        -  A computed tomography (CT) brain scan The participant will lie still on a table that          slides into a large donut-shaped scanner.        -  Blood drawn through an arm vein for analysis        -  A magnetic resonance imaging (MRI) scan of the brain and spine. They will lay flat in a          long metal cylinder as the machine makes images of the body. During the scan,          participants will receive a contrast agent through an IV that allows high resolution          imaging of the brain and spine        -  Participants will visit the clinic at 0, 1, 2, 3, 6, 12, and 24 months (7 times), and          depending on the need for monitoring, more times. Participants will receive a schedule          that will explain the procedures done at each visit.        -  At these visits, participants may:        -  Repeat the screening procedures.        -  Be asked about their NCC symptoms and their physical and mental health.        -  Have a urine test.        -  Take a test of their ability to concentrate, their memory and spatial recognition.        -  Have a lumbar puncture, if indicated by the state and severity of infection. A needle          will be inserted through the skin and into the space between the bones in the back.          Cerebrospinal fluid will be removed.   "
80376|NCT02233842|"     Background:      - People who have cancer have more medical problems if they smoke. Some studies show that     smoking even makes cancer treatment less effective. Researchers want to teach people about     how tobacco use affects people after a cancer diagnosis. They want to come up with questions     for people who have cancer and who have survived cancer. The questions will be about using     cigarettes and other tobacco products and about second-hand smoke.      The questions will be used to understand how using tobacco affects people with cancer before,     during, and after treatment. This will help doctors plan how to treat people with cancer and     create programs to help people quit smoking in the future.      Objective:      - To evaluate and refine questions that assess tobacco use.      Eligibility:      - Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any     site and any stage.      Design:        -  This study will take about 1 hour.        -  Participants will meet one-on-one with an interviewer. They will fill out a          questionnaire and talk about the questions. Participants will explain how easy or hard          it was to answer the questions and how they decided on their answers.        -  All participants will be asked the same or very similar questions. Specific questions          will be based on the participants own experiences with tobacco products.        -  There will be no follow-up activities.   "
80377|NCT02233829|"     Background:      - Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make     these effects sensitive to the time of day they are taken. Cocaine can affect these genes in     the brain. Researchers want to measure brain dopamine at different times of day.      Objectives:      - To look for changes to a person s biological clock in the function of the dopamine reward     system. To test if cocaine disrupts this.      Eligibility:        -  Adults age 21-55 with a cocaine use disorder.        -  Healthy volunteers age 21-55.      Design:        -  Participants will be screened with medical history, physical exam, interview, and blood          and urine tests. Their breath will be tested for alcohol and recent smoking.        -  Participants will have 3 overnight clinic visits.        -  Visit 1: They will have blood and urine collected and a heart test.        -  A plastic tube (catheter) will be placed into a vein in each arm by needle.        -  Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that          slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug          (blocks dopamine removal) will be injected via catheter. Vital signs will be measured          and blood will be drawn throughout.        -  Visit 2: repeats Visit 1, except at night.        -  Visit 3, participants will have urine collected.        -  They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will          lie on a table that slides in and out of it, with a coil over their head.        -  Participants may answer questions, take computer or paper tests, and perform simple          actions.        -  For 1 week, participants will wear a wrist device that measures daily activity.   "
80378|NCT02233816|"     A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled     study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular     injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to     healthy adults 18-49 years of age.      A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to     receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP     influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM     sodium chloride (NaCl) + 0.01% Tween 80).   "
80422|NCT02233244|"     This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A     activity in healthy subjects.      The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood     levels will not change after treatment with CTX-4430.   "
80379|NCT02233803|"     This Phase IV study is an a multi-centre, randomised open label, two way cross-over design to     evaluate the efficacy, safety, and tolerability of NEUMOTEROL 400 in subjects with asthma.     The study will be used to demonstrate the non-inferiority of Budesonide/Formoterol Fumarate     combination (BFF) 400/12 micrograms (mcg) single capsule inhaler (NEUMOTEROL 400) compared     with BFF 320/9 mcg SYMBICORT Forte TURBUHALER® inhaler.      The population for this study will be adult subjects (>=18 and <=80 years) with a diagnosis     of asthma who have a pre-bronchodilator forced expiratory volume in one second (FEV1) of 40%     to 85% of the predicted normal value, and are receiving a stable dose of inhaled     corticosteroid inhaled corticosteroid (ICS) with or without long-acting beta-adrenergic     agonist (LABA) prior to screening.      The study will consist of six phases: Prescreening, Screening/Run-in (4 weeks), Treatment     Period 1 (4 weeks), Washout (minimum 4 weeks), Treatment Period 2 (4 weeks) and Follow-up (1     week). The total duration of the study for each subject will be at least 17 weeks. There will     be up to 6 study visits and a follow-up telephone call.      Pre-screening Visit will allow subjects who had recent asthma medication changes to be     stabilized prior to Screening. During the run-in and wash-out periods, all the subjects will     receive budesonide dry powder inhaler (DPI) 400 mcg twice daily (BID) (NEUMOTEX™ 400) and     salbutamol 100mcg pressurized metered dose inhaler (pMDI) on demand, as rescue medication.     The dose of NEUMOTEROL 400 (400/12 mcg) and SYMBICORT Forte (320/9 mcg) will be one     inhalation BID, and each treatment will be given to all subjects for 4 weeks (with a 4-week     Washout Period between treatments).      The study will include 300 subjects for screening so that at least 210 will be randomised and     a minimum of 168 subjects complete the study/are evaluable. Half the subjects will be on     Regimen A in Treatment Period 1and will then be crossed over to Regimen B in Treatment Period     2, and vice versa. Regimen A: BFF (400/12 mcg) by single capsule inhaler. Regimen B: BFF     (320/9 mcg) TURBUHALER inhaler. The treatment periods will be separated by a washout Period     of 4 weeks.      NEUMOTEROL and NEUMOTEX are trademarks of the GSK group of companies SYMBICORT and TURBUHALER     are trademarks of AstraZeneca   "
80380|NCT02233790|"     The patients with acute myocardial infarction (AMI) present high mortality and morbidity     rate,even treated with stenting in the blocked heart vessels.      The appearance of no-reflow is common after re-opening of the blocked vessel. The no-reflow     were commonly attributed to tiny blockage in coronary micro-vasculature by thrombus and spasm     of the micro-vessel during stenting.      An agent with more effective anti-clotting and micro-vessel dilation would be helpful to     solve the issue of no-reflow. Ticagrelor was demonstrated to be a potent platelet inhibitor     and a potent micro-vessel dilator which can influence metabolism of adenosine, a endogenous     potent small vessel dilator.      This study is to test the effectiveness of ticagrelor on improving reperfusion and minimizing     the myocardial infarct size after PPCI in patients with AMI.   "
80381|NCT02233777|"     The present study was conducted to find out whether the bioavailability of 150 mg pregabalin     capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule     150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).   "
80382|NCT02233764|"     In this study, iron- and zinc-biofortified pearl millet will be fed to young children in     Mumbai, Maharashtra, India over a period of nine months to measure growth, cognitive changes,     and immune function in comparison to children receiving non-biofortified pearl millet.   "
80383|NCT02233751|"     Evaluation of pharmacokinetic and safety profile of testosterone after a single dose using     auto-injector   "
80384|NCT02233738|"     Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are     heavily represented in VA housing. VA recently adopted a 'Housing First' approach emphasizing     rapid housing placement to initiate recovery without requiring sobriety and will necessitate     SUD interventions that are efficient and easily layered onto existing services. The proposed     study will investigate the effectiveness, implementation process, and cost estimate of Group     Motivational Interviewing (GMI) for Veterans with SUDs in VA housing (Housing Urban     Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]). Outcomes will be     assessed at multiple time points using a multi-modal approach. The ultimate goal of this     research is to establish the basis of a GMI dissemination and implementation course of action     for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in     attaining housing stability.   "
80385|NCT02233725|"     Prostate cancer is the most common cancer in men. It is most often detected by an abnormal     digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test. When     it is suspected that someone may have prostate cancer, a biopsy is ordered. This biopsy is     performed by the Radiologist with ultrasound guidance through the rectum. In some patients, a     Magnetic Resonance Imaging (MRI) scan of the prostate may be ordered to further evaluate the     prostate. In some situations, the MRI and Ultrasound images will be fused (digitally merged)     together during the ultrasound procedure to help localize the questionable lesions. Recent     research has used an additional component known as a contrast agent - an intravenously     injected inert substance - which is identifiable by ultrasound. This inert substance is more     obvious in areas of increased blood flow, which is a common finding in cancerous lesions. In     this research project, we would like to determine whether the use of contrast-enhanced     ultrasound is beneficial in improving accuracy of the biopsies taken and the relative     correlation to the MRI/ Ultrasound-fused images.   "
80386|NCT02233712|"     An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study     in patients with Stage I-III gastric cancer. The first group of patients received a starting     dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500     µg was based on antibody response and dose tolerability.   "
80387|NCT02233699|"     The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in     reducing the daytime cough frequency in patients with chronic idiopathic cough.      The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective     24-hour cough frequency, hourly change in cough frequency, cough severity (via visual     analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester     Cough Questionnaire (LCQ) will be evaluated.   "
80388|NCT02233686|"     The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in     reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease     (COPD).      The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective     24-hour cough frequency, hourly change in cough frequency, cough severity (via visual     analogue scale [VAS]), urge to cough (via VAS), global rating of change scale, Clinical COPD     Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory     Questionnaire (SGRQ-C) will be evaluated.   "
80420|NCT02233270|"     When compared to existing analyses: manometry, Smart Pill and lactulose breath testing,     external Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) may identify unique audible     patterns characteristic of features of gastroinestinal (GI) motility, gastric and small bowel     contractions and emptying and small intestinal bacterial overgrowth (SIBO). This research     study is designed to test the capabilities of AbStats/AEGIS to identify and associate     symptoms and traditional diagnostics with sound readings and correlate this data with     treatment outcomes and successes in standard of care.   "
80389|NCT02233673|"     Excessive weight gain during pregnancy, particularly in overweight and obese women,     predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal     health. With an inverse relationship between socioeconomic status and obesity, significant     health disparities exist between obese and normal weight women. The Institute of Medicine     (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid     body mass index (BMI), to minimize pregnancy complications. However, these recommendations     are based on cross sectional observational studies and neither the ideal method to achieve     weight gain goals nor whether perinatal outcome is optimized with active management of weight     gain is known. The investigators propose to investigate a behavioral incentive-based     intervention to improve compliance with IOM weight gain recommendations during pregnancy in     low-income overweight and obese women. The investigators will evaluate if 1) gestational     weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain     management during pregnancy improves perinatal outcomes. Two study groups will be compared in     a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those     receiving behavioral weight management counseling plus financial incentives for achieving     weight gain goals. The main outcome measure will be the percentage of women gaining within     the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include     fetal growth and body composition changes, birth weight and the rate of cesarean delivery.     The investigators hypothesize that 1) the behavioral intervention with incentives will result     in greater compliance to IOM guidelines for gestational weight gain than standard care and 2)     targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal     macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be     examined. This intervention, if efficacious and cost-effective, has the potential to improve     compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce     health disparities.   "
80390|NCT02233660|"     This randomized clinical trial will investigate changes in hand function, active cervical     range of motion and pinch grip force after the application of physical therapy in women with     carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function,     cervical range of motion and pinch grip force induced after the application of a physical     therapy program including manual therapies targeted to those areas related to the median     nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The     hypothesis is that manual therapy is more effective for increasing cervical range of motion     and pinch grip force, but similarly effective for improving function, than surgical treatment     in women with CTS.   "
80391|NCT02233647|"     This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a     pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will     be conducted in which the subjective and physiological effects of cocaine are evaluated     during maintenance on placebo and phendimetrazine.   "
80392|NCT02233634|"     Patients with an impaired blood supply of the heart routinely receive oxygen in order to     improve or preserve the oxygen supply of the heart muscle in acute cardiac care. In recent     studies a new innovative MRI-technique that can detect changes in oxygen supply of the heart     was able to show that the administration of oxygen or fast breathing can decrease the blood     supply of the arteries supplying the heart muscle with oxygen. Thus, the administration of     oxygen may paradoxically impair the oxygen supply of the heart muscle. In this study the     investigators want to investigate, whether the administration of exogenous oxygen via a mask     alone and in combination with fast breathing leads to a decrease in oxygen supply in regions     with already impaired blood supply by a narrowing of a coronary artery of the heart.   "
80393|NCT02233621|"     Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of     the main problem of endometriosis is the significant delay of diagnosis.This delay has     significant consequences for patients. Currently the definitive diagnosis of endometriosis     and the evaluation of its lesional extension require performing laparoscopy and a     histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose     development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES     (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission     tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this     functional imaging as a diagnostic tool for endometriosis.      The aim of this multicenter, prospective, open study is to assess sensitivity of PET with     [18F] -FES for diagnosing endometriosis compared to the gold standard (histological     confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for     suspected endometriosis and for whom laparoscopy is already scheduled.   "
80394|NCT02233608|"     Radical prostatectomy is a common and effective treatment for prostate cancer but is     associated with urinary incontinence that can persist for several months after surgery and     significantly reduce quality of life. Studies have shown that routine performance of pelvic     floor exercises after radical prostatectomy can aid in the recovery of urinary control;     however, conventional pelvic floor exercises do not produce consistent results. Research     indicates that incorporating other deep abdominal muscles can further activate the pelvic     floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates'     and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises     with activation of supportive muscles. Our proposed study will be the first to test the     effect of an advanced pelvic floor exercise training program that includes Pfilates and     Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim     of this study is to assess the feasibility of conducting a full-scale RCT of an advanced     pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates,     and Hypopressives techniques on urinary incontinence. Feasibility will be determined by     measuring recruitment success, retention, outcome capture, and intervention adherence,     tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate     cancer in the advance pelvic floor training program will report greater improvement in     urinary incontinence and health-related quality of life.   "
80395|NCT02233595|"     The investigators will be using the combination of FDG-PET and multiparametric MRI in pre-     and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response     on surgical resection.   "
80396|NCT02233582|"     Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute     mountain sickness such as headache and malaise. However, the blunting of inflammation by     ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of     inflammation for adjustments in breathing.      The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to     altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue     oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that     subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours at     altitude than will placebo subjects.   "
80397|NCT02233569|"     This is a monocenter randomized controlled trial comparing two systems of mesh and fixation     device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has     been designed as a superiority study to proof the concept of previously published     mathematical model of front abdominal wall.   "
80398|NCT02233556|"     Patients with schizophrenia are deeply affected by the positive symptoms, negative symptoms     and cognitive impairment. A generalized cognitive deficit could be frequently observed and     traced back to early stage of the disease. Currently medication intervention significantly     improves positive symptoms through dopamine receptor modification, leaving alone the negative     symptoms and cognitive impairment. Besides dopamine dysregulation, more and more attention     had been paid to the association of N-methyl-D-aspartate (NMDA) type glutamate receptor and     schizophrenia, focusing on the neurobiological and cognitive biomarkers change. Memantine, an     uncompetitive antagonist of NMDA type glutamate receptor approved as cognitive enhancer for     Alzheimer's disease, is a potential candidate for preventing cognitive decline of     schizophrenia. Previous randomized clinical trials failed to demonstrate its efficacy on     chronic schizophrenic patients and it might be related to the chronic and irreversible     disease process. There is also study supporting that memantine induces change in mismatch     negativity (MMN) in frontal cortex of healthy subjects. This study will compare the MMN     change of healthy subjects and the population of early schizophrenia, who has persistent     neurobiological, cognitive biomarkers or negative symptoms despite subsided positive     symptoms. Both male and female aged 20-45 years old outpatients with a length of illness for     less than 5 years since first diagnosed as schizophrenia, currently receiving treatment by     atypical antipsychotics in a relatively stable condition will be recruited. Healthy subjects     will be recruited comparing their age and sex. We plan to recruit 10 subjects for both     patient and healthy subjects with a total of 20 participants. All participants will receive     general clinical, cognitive and event-related potential (ERP) evaluation as baseline before     taking medication. Twenty mg of memantine will be given 4 hours before ERP retest. The     analyses will be performed based on the change of ERP using paired-t sample test. Baseline     clinical and cognitive symptoms will be analyzed as possible confounders.   "
80399|NCT02233543|"     The purpose of this study was to determine whether a fixed dose combination of indacaterol     and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic     Obstructive Pulmonary Disease.   "
80400|NCT02233530|"     This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger     Identification and Intervention for Dementia in Elderly Africans (IDEA) study.      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to     facilitate diagnosis of, and therapy for, people with dementia led by local communities in     sub-Saharan Africa. The investigators seek to improve quality of life for people with     dementia and their caregivers.      Within this trial of CST, the investigators hypothesise that CST can significantly improve     the quality of people with dementia and their carers living in Africa   "
80401|NCT02233517|"     Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S.     Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among     their top priorities. PTSD-related anger and aggression are associated with profound     functional impairments, yet to date there are no empirically-supported treatments for     Veterans with PTSD and aggression. Effective group treatment programs could improve     functioning and facilitate community reintegration for these Veterans. Given that anger     impedes progress in treatment of PTSD symptoms, group anger treatment could also improve     Veterans' capacity to benefit from individually-administered empirically-supported therapy     for PTSD such as prolonged exposure or cognitive processing therapy.   "
80402|NCT02233504|"     The purpose of this trial is to examine the hematologic response rate of Exjade® in patients     with AML and high risk MDS and chronic iron overload from blood transfusions. Deferasirox has     been developed as an iron-chelating agent, and unlike deferoxamine, a previously developed     iron chelator, deferasirox has the advantage of oral administration.   "
80403|NCT02233491|"     Post-transplantation diabetes mellitus (PTDM) is a common medical complication after kidney     transplantation, related to both transplant-specific and generic risk factors, and is     associated with major complications after transplantation. The current PTDM Consensus Report     recommends lifestyle modification (e.g. weight loss, dietary modification, structured     exercise program) as the first line therapy of choice. No recommendation is given with     regards to how such guidance should be delivered. In addition no clinical evidence exists to     suggest lifestyle modification provides any sustained glycaemic benefits for kidney allograft     recipients.      While in the general population the benefits of lifestyle modification have been well     documented with regards to attenuation of both pre-diabetic and diabetic states in the     context of randomised controlled trials, no similar level of evidence exists post kidney     transplantation.      This prospective randomised controlled trial is designed to compare active versus passive     lifestyle intervention post kidney transplantation, to determine changes in cardio-metabolic     risk profile over the course of the intervention.   "
80404|NCT02233478|"     This study is comparing the quantity of active metabolites from consuming pomegranate juice     in three different preparations. People who participate in this study will come in to the     Center for a screening visit, which includes a blood test and medical history. If you qualify     based on the screening visit, you will then come in to the Center while fasting in the     morning on three different days. You will eat a standardized breakfast and drink one of three     juices, and then remain for metabolic testing at the Center for a period of time after     eating. You will also be provided a standardized lunch and water during this period. Each of     those visits will last about 7 hours. During this time, and for the rest of the 24 hours     following drinking the juice, you will collect all of your urine. Following all three of     these 7-hour visits, you will return to the Center again the next day for a fasting blood     draw, drop off your urine sample, and pick up a new container to collect another 24 hour     urine sample. The following day, you will return to the Center to drop off your second urine     sample collection.   "
80405|NCT02233465|"     Parastomal herniation is difficult to treat. Several different treatment has been tested but     still none has revealed to be superior. The use of a mesh has been shown to be a promising     way of treating. In this study the investigators will evaluate safety and hernia recurrence     rate with a mesh tailored to treat parastomal hernias Parastomal hernia mesh BARD in     patients with parastomal hernia requiring surgery.   "
80406|NCT02233452|"     Methadone and ketamine are effective for neuropathic pain management. However, the benefits     of the association of both drugs are uncertain. Here, the investigators conducted a     randomized, double-blind, in parallel, active controlled clinical trial to test the     hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than     methadone or ketamine alone in reducing neuropathic pain.   "
80407|NCT02233439|"     The purpose of this study is to assess the effectiveness of a commercially available product     containing a combination of Silybum marianum and Galega officinalis to support continuation     or augmentation of breast milk production.   "
80408|NCT02233426|"     The purpose of this study is to assess the effectivity of using hypertonic nasal solutions     alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients,     retrospectively.   "
80423|NCT02233231|"     This is a study describing changes in inflammation of the airways in asthmatics before and     after smoking cessation and steroid treatment.   "
80410|NCT02233400|"     Bariatric surgery is the only proven and effective long term treatment for morbid obesity. In     an attempt to reduce patients' post-operative hospital stay, lower associated health care     costs, and improve satisfaction scores, St Luke's University Health Network (SLUHN) recently     adopted a fast track bariatric surgery (FTBS) protocol. Findings to date show that FTBS is     safe and effective when performed in a Center of Excellence (COE) such as ours. However,     post-operative pain control remains a challenging issue, with only intravenous (IV) or PO (by     mouth) narcotics appropriate for bariatric surgery patients.      IV acetaminophen, which has been used successfully in Europe, was recently approved by the     Federal Drug Administration (FDA) for use in the US. However, no data exist regarding the use     of IV acetaminophen in bariatric surgery patients, nor are there any data assessing its cost     effectiveness. Therefore, our study will investigate the economic impact of administering IV     acetaminophen to bariatric surgery patients, as well as its effect on clinical outcomes such     as patients' post-operative length of stay, self-reported pain, readmissions, emergency room     (ER) visits and complications.      The study design will be a randomized, double-blind, parallel-group, controlled trial in a     single bariatric Center of Excellence (COE) that is part of the St. Luke's University Health     Network (SLUHN). Patients will consist of up to 200 morbidly obese adult bariatric surgery     candidates > 18 years of age undergoing either laparoscopic Roux-en-Y Gastric Bypass (LRYGB)     or laparoscopic Sleeve Gastrectomy (LSG). Group 1 (treatment) will receive IV acetaminophen     plus IV narcotics for the first 6 hours post-surgery followed by IV/ PO narcotics for the     remaining 18 hours. Group 2 (control) will receive IV normal saline plus IV narcotics for the     first 6 hours post-surgery followed by IV/PO narcotics for the remaining 18 hours. Data     analysis will include quantile regression, mixed randomized-repeated analysis of covariance     (ANCOVA) and selected univariate comparisons, with p < .05 denoting statistical significance     for all outcomes.   "
80411|NCT02233387|"     The aim of this study is:        1. to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in          cervix cancer,        2. to correlate the [18F]HX4 PET images with blood and tissue markers,        3. to investigate the quality and optimal timing of [18F]HX4 PET images,        4. to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and        5. analyze correlation with responses   "
80412|NCT02233374|"     The purpose of this study is to investigate if PET/CT and MRI scans performed early in     treatment and six weeks after treatment can predict the response of rectal cancer following     chemotherapy and radiotherapy. This will help doctors to better tailor treatments for rectal     cancer in the future.   "
80413|NCT02233361|"     The proportion of elderly people is expected to increase greatly within the next couple of     decades, resulting in a proportional increase in the need for hearing rehabilitation.     However, studies suggest that as many as 40% of hearing aids are never or seldom used. Thus,     a major challenge for audiological rehabilitation is facilitating the use of fitted hearing     aids.      This study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up     appointment on hearing aid use, 2) to implement a specialized counselling program based on     MI, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use     with datalogging technology.   "
80414|NCT02233348|"     Autism spectrum disorders (ASD) is a common childhood-onset, multi-factorial, highly     heritable, clinically and genetically heterogeneous, neurodevelopmental disorder. Due to its     high prevalence and severe lifelong impairment without effective prevention and treatment,     there is a dearth of investigating its pathogenesis, longitudinal outcome, and biomarkers     (endophenotypes). The ultimate goals of this 5-year project are to prospectively investigate     the outcome and changes of psychosocial and neurocognitive functions of a cohort of probands     with ASD at adolescence and young adulthood as the primary aim; and to test whether     structural and functional brain connectivity can be effective endophenotypes of ASD using the     unaffected sibling and follow-up designs as the secondary aims.   "
80415|NCT02233335|"     Cushing syndrome refers the manifestations induced by chronic glucocorticoid excess and may     arise from various causes. Iatrogenic Cushing syndrome accounts for most patients, when they     are given exogenous glucocorticoid treatment. In contrast, spontaneous Cushing syndrome     results from endogenous glucocorticoid over-secretion. Although Cushing disease is rare, it     is the most common cause of spontaneous Cushing syndrome. The patient with Cushing disease     has a pituitary corticotroph adenoma, which overproduces adrenocorticotropic hormone (ACTH).     ACTH then stimulates adrenal gland to over-secret glucocorticoid. Patients with untreated     Cushing disease were shown to have poor prognosis, estimated a 5-year survival rate of 50%.     The first line treatment is tumor resection. Other managements include radiotherapy,     medication and bilateral adrenalectomy. The initial remission rate is high (66-90%). However,     some patients encounter with disease recurrence during follow-up.      The aim of this study is to clarify the factors associated with the recurrence after     treatment. In this study, we will review the patients with Cushing disease thoroughly and     analyze associated predisposing factors. These risk factors can remind the clinical physician     to early detect the recurrent disease in these patients, and further prevent morbidity and     mortality in their later lives.   "
80416|NCT02233322|"     The purpose of the study is to gain a better understanding of the effect of iron on     fibroblast growth factor 23 (FGF23) in the inherited disorder, autosomal dominant     hypophosphatemic rickets (ADHR). ADHR is an inherited disorder in which the body makes too     much FGF 23 and causes low blood phosphorus levels and bone problems such as rickets (bowed     legs in children) or bone pain and weakness in adults. This study is to test whether or not     giving iron helps correct the high FGF23 and there by correcting the phosphate problem.   "
80417|NCT02233309|"     This study is a prospective study of epidural pressure changes when local anesthetic is     injected from the caudal route. All patients will receive the same weight based volume dose     of local anesthetic after induction of general anesthesia, and a CVP transducer will be     attached to the standard caudal needle for measurement of pressure: under the skin, after     entering the epidural space, and every 15 seconds for 3 minutes after completion of injection     with the needle in situ. The placement of the caudal epidural will follow current standard of     care and administration, the only variation will be the addition of a pressure transducer to     the stopcock where the local anesthetic syringe is attached that will allow for pressure     monitoring.   "
80418|NCT02233296|"     This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of     lasmiditan in healthy subjects.   "
80419|NCT02233283|"     Undernutrition has a known and well recognized negative impact on reproductive hormones, and     ultimately fertility. In contrast, much less is known regarding the potential effects of     overnutrition on the same hormones. Epidemiological data suggest that overnutrition might     have a deleterious impact as well on the fertile potential of affected women, but very little     is known about the mechanisms implicated. Such knowledge may be of importance, given the     increasing prevalence of overweight and obesity worldwide.   "
80424|NCT02233218|"     To investigate the pharmacokinetic Drug-drug interaction   "
80426|NCT02233192|"     The purpose of this study is to observe patient response to current clinical practice     utilizing TRUVADA (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure     Prophylaxis (PrEP) amongst HIV serodiscordant couples desiring to conceive across four U.S.     cities that are currently offering this method as standard of care. This study is an     observational cohort study, which will test the feasibility and acceptability of PrEP for     conception, while examining the challenges and generalizability of this current medical     practice. The CDC recently released formal clinical practice guidelines for the use of PrEP     in the United States. For high-risk serodiscordant heterosexual couples using PrEP during     conception, the guidelines state, PrEP use periconception and during pregnancy by the     uninfected partner may offer an additional tool to reduce the risk of sexual HIV acquisition.     Both the FDA labeling information and the perinatal antiretroviral treatment guidelines     permit this use (CDC 2014).   "
80427|NCT02233179|"     The aim of the study was to explore the association between activities of daily living (     measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an     exploratory study, there was no study hypothesis.   "
80428|NCT02233166|"     In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first     choice of treatment. Studies in recent years have shown that the procedure does not always     have the expected effect. Children with OSA are at greater risk for complications from the     procedure.      There is disagreement regarding the need for sleep studies in children prior to surgery in     order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography     (PSG).      The main purpose of this study is to describe the prevalence of OSA among children referred     for adenotonsillectomy.      The investigators will also examine these children prior to and six months after surgery to     assess their sleep pattern and quality of life.      The project outcome aims to improve the precision and quality of diagnosis and the short and     long term effects of treatment of children with OSA.   "
80429|NCT02233153|"     The aim of this study is to examine the impact implementing an elder-friendly surgical unit     has on post-operative complications, mortality and quality of life for patients ≥ 65 years     old who have undergone emergency surgical care.   "
80430|NCT02233140|"     Diabetic foot complications are a common and costly problem. Excessive plantar pressures due     to foot deformities and/or limited ankle dorsiflexion, especially in the presence of     peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers.     Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot     ulcers.      Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology)     was effective in treating subjects with chronic heel pain and Achilles tendonitis with no     serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to     perform more effective stretching exercises and may prevent recurrence of diabetic foot     ulcers.      The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus     manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk     subjects with a history of diabetic foot ulcer.   "
80431|NCT02233127|"     In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only     2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of     the causes of child mortality is necessary to guide research efforts aimed at tackling this     important global health problem. Prospective birth cohort studies present an opportunity to     examine the relationships between early-life exposures and multiple health and non-health     related outcomes including death, illness, and socioeconomic factors. In this study, we will     provide insight into the underlying causes of child mortality by collecting high-quality data     on early-life exposures and health and non-health related outcomes in the first year of life.   "
80432|NCT02233114|"     Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and     quality of life in patients with obstructive lung diseases. With follow up after 6 months.   "
80433|NCT02233101|"     Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the     different routes of drug administration are equivalent in terms of post-operative reduction     in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery.      Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.   "
80434|NCT02233088|"     Approximately 24% of the US adult population meet criteria for metabolic syndrome (MetS),     diagnosed by a combination of abdominal obesity, elevated blood pressure, high triglyceride     and low HDL-cholesterol level, and pre-diabetes. MetS quintuples the risk of diabetes, and     doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle     modification is the initial step of treatment, but few studies have demonstrated early and     sustained efficacy in remission of MetS. Our preliminary studies of a lifestyle change     program for patients with MetS included a 1-year of development of an intervention by an     interdisciplinary team of experts in medicine and the behavioral sciences. The investigators     then tested the efficacy of the intervention in a treatment-only, proof-of-concept study. The     investigators achieved our goal of 50% MetS remission after 2 years, in a sample of 26     patients. This study is the second step of a research program testing an innovative     bio-behavioral intervention aimed at remitting MetS through lifestyle intervention, by     focusing on eating patterns, daily activity, and stress management. The overarching objective     of this research program is to determine the efficacy of the ELM lifestyle intervention to     achieve remission of MetS. This purpose of the current study is to prepare for a large,     randomized, clinical trial by conducting a smaller clinical trial that examines the     acceptability of the ELM intervention (ELM Group) as compared to two other intervention arms     (ELM Classes, ELM Individual).   "
80456|NCT02232802|"     This will be an open-label, randomised, single-dose, 2-way crossover study to determine the     comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80 mg/0.8mL)     with that from the reference IMP, Clexane® s.c. (80 mg/0.8mL), following single dose     administration in healthy male and female subjects.   "
80457|NCT02232789|"     The purposes of this study are 1) to evaluate the abuse liability and human pharmacology of     mephedrone after oral administration and 2) to compare the pharmacological effects of     mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine     (MDMA, ecstasy).   "
80458|NCT02232776|"     The investigators hypothesize that using Losartan would help decrease proteinuria in     controlling proteinuria in children with immunoglobulin A nephropathy.   "
80435|NCT02233075|"     REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to     clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV     infected ducks) and in human patients and to act synergistically with immunotherapeutic     agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host     immunological control of HBV infection.      HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action     of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated     interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection.      This study will examine the safety and efficacy of REP 2139-Ca therapy when used in     combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection.      The primary hypothesis to be tested is that this combined dosing regimen is safe and well     tolerated in patients with HBV / HDV co-infection which will be assessed by examining the     number of patients with adverse events (including reported symptoms and laboratory     abnormalities).      The secondary hypothesis to be tested is that this combined dosing regimen will have an     antiviral effect against HBV / HDV co-infection in these patients which will be assessed by     examining the following outcomes:        1. The number of patients with reductions in serum HBsAg.        2. The number of patients with reductions in serum HDAg and HDV RNA        3. The number of patients that experience a sustained antiviral response after treatment is          stopped (reductions in serum HBV DNA and HDV RNA).      The secondary hypothesis to be tested is that this combination approach can have an effective   "
80436|NCT02233062|"     The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm     quality of patients with crohn's disease.   "
80437|NCT02233049|"     Diffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and     adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the most     common malignant brain tumours, there are only 30 to 40 new cases per year in France. Their     clinical presentation is stereotyped with a short clinical history and a unique MRI     appearance that was usually considered as sufficient to establish the diagnosis. The     prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in     general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave     2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of     paediatric oncology; despite numerous collaborative studies performed, patients' survival has     not significantly increased in thirty years (Hargrave 2009). There is no validated prognostic     factor. There is currently no validated treatment except radiotherapy.      Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger,     2011), without knowing whether the target was present in the tumour. A critical review of the     paradigms of these trials tells us that there are long term survivors in these studies that     is to say patients who may have benefited from the tested therapy, but they are few. So far,     the new therapies that have been tried were evaluated one after the other in search of a     treatment that would be effective for all patients, measuring the treatment effect on median     survival. They were all rejected as ineffective. However the investigators can challenge the     endpoint to evaluate efficacy in these trials as the existence of long term survivors (> 18     months, for example) and their number should not been ignored, especially if targeted     therapies are considered. The investigators propose a paradigm shift in the choice of     treatment; the issue raised would be to give to each patient the treatment associated with     the highest likelihood of efficacy based on the specific biological tumour profile.      The development of targeted therapies for malignant gliomas infiltrating the brainstem has     been hampered by the absence of biological data. It is therefore crucial to better understand     the biology of these tumours. Despite the safety of the biopsy in brainstem tumours, most     teams of paediatric neurosurgery limit the use of stereotactic biopsy only for clinically or     radiologically unusual forms. Until recently, there has been no systematic genetic study at     diagnosis to date and the few available data were confounded by the inclusion of autopsies or     clinically and radiologically unusual cases (Louis, 1993; Gilbertson 2003; Okada, 2008;     Zarghooni 2010; Broniscer, 2010; Wu, 2012 and Schwartzentruber, 2012).      French teams gathered in the French Society of Paediatric Oncology and the European     consortium Innovative Therapies in Children with Cancer (ITCC) decided a few years ago to     perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of     certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted     therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team of     the Necker Hospital in Paris, confirming the low rate of complications of stereotactic biopsy     procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing     immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct     sequencing of candidate genes studies.      In this study, the majority of patients will receive a treatment assumed to specifically     target a biological abnormality identified on the biopsy. More importantly, patients will not     receive a drug for which the identified target is absent.      In this first step of the protocol, the patients will thus be allocated to one of the three     treatment groups as follows:        -  If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive          erlotinib or dasatinib allocated by randomization (R1 randomisation).        -  If the tumor shows loss of PTEN expression without EGFR overexpression, patients may          receive everolimus or dasatinib allocated by randomisation (R2 randomisation).        -  If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may          receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation).        -  If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare          situation in our experience), patients will receive dasatinib (no randomisation).        -  If the biopsy assessment is not contributive, the treatment will be allocated by          randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).   "
80438|NCT02233036|"     Background:      People who get chronic illnesses as children are living longer. When they turn 18, they     switch from pediatric care to adult care. This can be a difficult change. Chronic     Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated     infections. People with CGD are usually diagnosed when they are very young children.     Researchers want to find out more about how young people with CGD handle the change to adult     care. What they learn may make this easier for people with CGD in the future.      Objective:      - To identify what helped or hurt young adults with CGD as they went from pediatric to adult     care.      Eligibility:      - Adults with CGD who were 18 24 years old between January 2011 and February 2014.      Design:        -  Participants will already be enrolled in NIH studies.        -  Eligible people will get materials in the mail. They will get a letter with study          information, an interview questionnaire, and an information sheet.        -  Researchers will call participants 1 week after the packets are sent. They will talk          about the study and find out if the person wants to join.        -  An interview will be completed immediately or scheduled for the future. The interview          will take about 45 minutes. The researcher will ask the participant about their disease.          They will also ask about travel to NIH, being an outpatient or inpatient there, and          legal documents.        -  Researchers may contact the subjects again by phone if they need more information at any          point during the study.   "
80439|NCT02233023|"     Study to assess and compare the safety of long term oral treatment for Parkinson's Disease     with pramipexole versus bromocriptine or other dopamine agonists, by measuring     cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal     degeneration, in a matched pair design   "
80440|NCT02233010|"     Although post-op renal function decrease is determined by serum creatinine, serum creatinine     has disadvantages that it increases a long time after renal function decrease and it has     various increasing time based on the level of renal function. Neutrophil     Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage     occurring from post-op cardiac surgery, being critical patients and contrast medium use is     already proven.      But NGAL's usefulness for renal function after non-cardiac surgery is not proven and     especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal     disease patients is not proven.Therefore, the investigators will study about renal function     decrease after non-cardiac surgery with NGAL and serum creatinine.   "
80441|NCT02232997|"     No well-defined protocols exist to guide fluid administration for prevention of contrast     induced nephropathy in high risk patients. The investigators will compare long term hydration     at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at     high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the     short term hydration may not be inferior to the long one.   "
80442|NCT02232984|"     The purpose of the study is to evaluate different ways to program around extracardiac     stimulation.   "
80443|NCT02232971|"     Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin     and are advised to aim for near-normalization of blood glucose levels through intensive     insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined     use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of     treating patients with soluble glucagon has arisen and thus studies of low dose glucagon     treatment of mild hypoglycemia are needed to determine whether there is clinical rationale     for dual-hormone treatment of T1D.      Aim: The purpose of this clinical study is to investigate the glycemic response to     subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with     insulin pump. Different glucagon doses are applied to determine the most appropriate dose for     future dual-hormone treatment of T1D.      Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D     patients treated with insulin pump are studied on four days. All patients are in good     metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On each     study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a     single subcutaneous dose of glucagon. The study procedures are identical on all days except     from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4:     300 ug). All patients are blinded for the glucagon dose and carry out the four days in random     order.      Endpoints: The present study focuses primarily on the dose related plasma glucose response of     glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the     glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and     triglycerides.      The study will be conducted from august 2014.   "
80444|NCT02232958|"     The purpose of this study is to extend our previous work, in which we demonstrated an     increase in the internal and cross network connectivity of resting state neural networks in     patients with cerebral small vessel disease by treatment with hyperbaric oxygen, to at least     20 more individuals.   "
80445|NCT02232945|"     This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen     granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.   "
80459|NCT02232763|"     The investigators hypothesize that using Losartan would help decrease proteinuria in     pediatric chronic kidney disease with tubular proteinuria.   "
80446|NCT02232932|"     A prospective, open-label, randomised, multicentre, comparative study in two parallel groups     comparing an interventional group with liver transplantation preceded by neoadjuvant     radio-chemotherapy and a control group receiving conventional liver and bile duct resection.      The primary endpoint will be overall survival at 5 years in the intent-to-treat population.     The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and     tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the     intent-to-treat population.      The number of subjects necessary is 54 patients (27 x 2): this population will enable the     demonstration of a significant difference is 5-year survival rates between the transplanted     group and the resected group with a power of 80% and a first-species risk of 5%, under the     hypothesis that these survival rates are 70% in the transplanted group and 30% in the     resected group.   "
80447|NCT02232919|"     The burden of morbid obesity to the circulatory, endocrine, and locomotor systems, as well as     the psychological effects and related health-care costs, are well established in the medical     literature. Lifestyle and dietary patterns remain critical factors modulating long-term     weight control of morbidly obese individuals (bodymass index ≥ 40). Various dietary,     pharmacological, and behavioral interventions have largely failed as therapies, often     necessitating surgery as the last treatment option. Long term results of bariatric surgery     suggest that sustained and substantial weight loss can decrease morbidity related to obesity     secondary complications such as diabetes type 2 and cancers, enhancing the role of surgery     for morbidly obese subjects. However the adverse effects of bariatric surgery are     considerable and impact on quality of life. Its long-term failure rates and complications     call for novel and effective long-term therapies, such as neurosurgical interventions.      The investigators now propose to enhance our targeting capabilities in a feasibility study of     low frequency electrical stimulation using VMH-DBS (ventromedial hypothalamic) in six     morbidly obese patients. After successful targeting, DBS stimulation parameters will be     systematically evaluated and individually optimized at three-month intervals over a one-year     stimulation period. Detailed recording of side effects, weight changes, food intake patterns,     metabolic changes, and behavioral evaluations will be obtained throughout the study.   "
80448|NCT02232906|"     Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce     dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron     status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron     schedule for 6 months prior to enrolment.   "
80449|NCT02232893|"     TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian     ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous     decoction and granulation technology. The aim of this study is to assess the effect of TU-100     on abdominal discomfort during the 4 week postoperative period after straight, hand-assisted,     or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for subsequent outcome     studies also will be explored.   "
80450|NCT02232880|"     The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug     Administration to treat rheumatoid arthritis, may help blood pressure medications to work     better. This will be studied in people with high blood pressure that is not well controlled     on three or more blood pressure medications, the condition also known as resistant     hypertension. We expect to show that adding abatacept therapy to standardized treatment of     resistant hypertension will result in a greater decrease in blood pressure at 24 weeks     compared to treatment with placebo and conventional blood pressure treatment.   "
80451|NCT02232867|"     It has been found that arm and leg cycling is similar to walking in terms of the muscle     activation patterns and joint ranges of motion. In addition, arm and leg cycling and walking     activate similar neural pathways. Another advantage of arm and leg cycling is that it     involves coordination of all four limbs in a rhythmic movement. This may be particularly     beneficial given previous findings that arm movement contributes to the activation of leg     muscles during walking in humans. This is achieved with interconnected neural pathways that     link the arms to the legs. These neural interlimb connections remain intact in stroke     victims, such that maximizing the contribution of the arms to the legs may increase     coordination for walking. Thus, the objectives of this research are to determine if arm and     leg cycling can be used to increase the strength of interlimb connections and if this helps     to improve walking ability in a post-stroke population. It is hypothesized that arm and leg     cycling will transfer to improvements in walking in a post stroke population.   "
80452|NCT02232854|"     According to the literature the management of depressive disorders at primary care level is     not always consistent with guidelines. The main objective of this study is to test whether a     Comprehensive Technology-Assisted Training and Supervision Program will improve depression     management in Primary Health Care clinics in Santiago, Chile.   "
80453|NCT02232841|"     The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance     Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are     mechanically ventilated. In electrical impedance tomography low amplitude, low frequency     current is applied on electrodes, and the resulting voltage is measured and used to computed     the electrical properties of the interior of the chest as they change in time. The computed     properties are used to form an image, which can then be used for monitoring and diagnosis.   "
80454|NCT02232828|"     Background: For treating deep caries lesions, selective or stepwise, i. e. one- and two-step     incomplete excavation seems advantageous compared with complete caries removal. However,     current evidence regarding the success, as defined by not requiring any re-treatments, or     survival of teeth after different excavations is insufficient for definitive recommendation,     especially when treating deciduous teeth. Moreover, restoration integrity has not been     comparatively analyzed longitudinally, and neither patients', dentists' or parents'     preferences nor the clinical long-term costs emanating from both initial and re-treatments     have been reported yet.      Our primary hypothesis is that success rates differ significantly between selectively and     stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to     significantly differ between selectively and stepwise excavated teeth.   "
80455|NCT02232815|"     This study will examine outcomes for patients treated by planned culotte stenting and compare     outcomes with 2 different stent platforms, the next generation Synergy II and the Xience     Xpedition DES platforms.   "
80461|NCT02232737|"     This study will examine extended exposure to cigarettes varying in nicotine content among     people with affective disorders. People with affective disorders are at an increased risk for     smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at     significantly increased risk for smoking-related adverse health consequences. Studies testing     an innovative regulatory strategy of reducing the nicotine content of cigarettes to a     non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced     toxicant exposure, and increased cessation) in the general population of smokers. However,     these studies have uniformly excluded vulnerable populations like people with current     affective disorders, who may respond differently considering their greater vulnerability to     smoking and nicotine dependence. Thus, little is known scientifically about how this highly     vulnerable subgroup of smokers may respond to a nicotine reduction policy. This project is     designed to fill that substantial knowledge gap.   "
80462|NCT02232724|"     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.     Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods     for staging of bone metastases are known to be inaccurate. Staging of lymph nodes requires     surgery associated with risk of bleeding etc. Prior studies from our department suggest that     PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of     this study is to compare the usefulness of Dual time point FDG PET/CT with current methods     for the staging of bone and lymph node metastases in patients with newly diagnosed prostate     cancer.      Better initial staging will result in better treatment of the individual patient. If we are     able to develop a more accurate and non-invasive method of staging patients with undetected     metastases on current staging will be spared of the side-effects associated with current     treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.   "
80463|NCT02232711|"     The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray     Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's     instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments     (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with     signs and/or symptoms of a respiratory infection. The study data will be used to support an     application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized     that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with     be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or     high complexity CLIA certification.   "
80464|NCT02232698|"     The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose     Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing     using a randomised controlled study design in adults with Type 1 diabetes using insulin.   "
80465|NCT02232685|"     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.     Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods     for staging are known to be inaccurate. Prior studies from our department suggest that PET/CT     is useful in staging of bone metastases in patients with prostate cancer. The aim of this     study is to test the usefulness of Choline PET/CT for the staging of bone metastases compared     to current standard methods in patients with newly diagnosed prostate cancer.      Better initial staging will result in better treatment of the individual patient. If we are     able to develop a more accurate method of staging patients with undetected metastases on     current staging will be spared of the side-effects associated with current treatment -     impotence, incontinence, radiation damage etc.   "
80466|NCT02232672|"     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.     Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods     for staging of bone metastases are known to be inaccurate. Staging of lymph nodes requires     surgery associated with risk of bleeding etc. Prior studies from our department suggest that     PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of     this study is to compare the usefulness of MeAIB PET/CT with current methods for the staging     of bone and lymph node metastases in patients with newly diagnosed prostate cancer.      Better initial staging will result in better treatment of the individual patient. If we are     able to develop a more accurate and non-invasive method of staging patients with undetected     metastases on current staging will be spared of the side-effects associated with current     treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.   "
80467|NCT02232659|"     The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and     Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent     (about to happen) death from irreversible biventricular heart failure.      The purpose of this research study is to evaluate whether the TAH-t can support patients with     life-threatening irreversible biventricular heart failure who are not eligible for     transplantation. The TAH-t, when used for patients who are not eligible for transplant, is     considered to be an investigational (not approved by FDA) use. This use is called destination     therapy (DT).      Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for     cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to     six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that     are experienced by the enrolled subjects and comparing them to previous experience of TAH-t     patients who were waiting for a heart transplant. Since approximately 74% of patients with     this condition would not be expected to live beyond six months, the benefit of the TAH-t for     DT will be confirmed based on survival to six months without experiencing permanent disabling     stroke-related deficits. After the six month follow-up visit, patients will continue to be     followed under the study for up to five (5) years postTAH-t implant [every six months for up     to two years while supported with the TAH-t implant and then annually for another three     years].      Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further     characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be     the same for patients enrolled in both arms of the study.   "
80468|NCT02232646|"     This is an open label, multi-center, Phase II study of BBI503 administered to adult patients     with selected advanced urologic malignancies. The primary objective of this study is to     evaluate the disease control rate of patients with renal cell cancer and urothelial carcinoma     treated with BBI503.   "
80470|NCT02232620|"     This is an open label, multi-center, phase II study of BBI503 administered to adult patients     with advanced gastrointestinal stromal tumor who have exhausted all currently approved     standard anti-cancer treatment options. BBI503 will be administered orally, daily, in     continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until     patients are no longer clinically benefiting from therapy due to disease progression, adverse     events, or another discontinuation criterion.      Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study     treatment.   "
80471|NCT02232607|"     The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg     decreased the symptoms of angina, compared to placebo in patients with chronic stable angina   "
80472|NCT02232594|"     The aim of this postmarketing surveillance is to obtain further information about the     tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic     obstructive respiratory tract disease under conditions of daily practice   "
80473|NCT02232581|"     The primary objective was to determine the mean change in HIV viral load from baseline to     Week 4 compared with placebo after 4 weeks of treatment in highly experienced HIV-infected     patients.      Secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety     of different doses of alovudine and (2) the effect of baseline nucleoside genotypic     susceptibility on virologic response after 4 weeks of alovudine administration   "
80474|NCT02232568|"     Trial of Feedback on Blood Use (TOFU)      The TOFU study will represent the first attempt to rigorously assess the impact of     audit-feedback on changing transfusion practice. The primary hypothesis is that providing     individual feedback on transfusion practice to orthopedic surgeons will reduce elective RBC     transfusions in the postoperative period.      TOFU is a two-arm, cluster-randomized controlled trial. Initially, baseline blood use data     will be collected at all study sites. Next, the PI at each site will give a short educational     presentation to the orthopedic surgeons. The presentation will consist of a standardized     10-minute presentation reviewing the data from the FOCUS trial and the recommended red blood     cell (RBC) transfusion trigger of 8 g/dL (or symptomatic anemia) based on that data. Clusters     of orthopedic surgeons will then be randomized to either the Control arm (no feedback) or the     Intervention arm (monthly feedback). All of the surgeons at a given site will either receive     or not receive feedback. The feedback will take the form of emailed monthly reports detailing     blood use by each surgeon post-hip surgery. Surgeons will be anonymized in the reports as A,     B, C . . . but each surgeon will know which data are his own. The primary end point is the     decrease from baseline in the proportion of patients transfused with a pretransfusion     hemoglobin of > 8 g/dL.      TOFU will be conducted at 8 sites in Europe and North and South America. Care has been taken     to minimize the labor and costs required to conduct this study. The only data collected will     be: patient age/gender; procedure; surgeon (anonymized); surgery & discharge dates; RBC units     transfused; Hgb levels. The data will be entered at each site into a web-based Case Report     Form, and will be stored centrally by the Data Coordinating Center (DCC). The DCC will     generate monthly feedback reports and email them to each Intervention arm site PI. The site     PI will then email the reports to each local orthopedic surgeon.   "
80475|NCT02232555|"     The purpose of this study was to investigate the efficacy of duloxetine versus placebo on     pain in outpatients with major depressive disorder (MDD): change in Brief Pain Inventory     Short Form (BPI-SF) 24-hour average pain score from baseline over the 8 weeks of treatment   "
80476|NCT02232542|"     Study to assess the safety and tolerability of 100 mg of duloxetine BID compared to 40 mg of     duloxetine BID or placebo for 7 days   "
80477|NCT02232529|"     The aim of the study is to assess how MIN-101 is taken up by the body when given in different     amounts and in different formulations. The drug will be given as a single dose in Part 1 of     the study and during Part 2 of the study as multiple dose, once daily for 7 days. The     ultimate aim is to find an optimal formulation which can be developed as a once daily dose     for the treatment of schizophrenia.   "
80478|NCT02232516|"     The purpose of this study is to evaluate how safe and effective the combination of the study     drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma     (PTCL) who have not been previously treated for this cancer. Currently, there is no standard     treatment for patients with PTCL; the most common treatment used is a combination of drugs     called CHOP, but this can be a difficult treatment to tolerate because of side effects, and     is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of     drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that     can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide     (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug     affects how tumor cells grow and survive, including affecting blood vessel growth in tumors.     It is given as an oral tablet (by mouth).   "
80479|NCT02232503|"     The aim of the study is to find out prevalence and individual stages of Diabetic Retinopathy     in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements     in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of     diabetic retinopathy (DR) and diabetic macular edema (DME) in relation to type and duration     of diabetes mellitus and risk factors. Project will also identify genetic factors linked with     the diseases.   "
80480|NCT02232490|"     Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic     benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular     carcinoma.   "
80481|NCT02232477|"     This is a five-year extension study of the pilot study, Intrathecal Enzyme Replacement for     Cognitive Decline in MPS I. Participants must have completed the pilot study to participate     in this study.   "
80499|NCT02232243|"     Baseline levels of PAR-4 secreted by normal cells are generally inadequate to cause massive     apoptosis in cancer cells and drugs that bolster the secretion of PAR-4 would constitute an     important therapeutic advance.The apoptosis sensitizing features of hydroxychloroquine     enhance the anti-tumor effects of a broad range of cancer therapeutics. The investigators     hypothesize that hydroxychloroquine will induce at least 2-fold increase in systemic (plasma)     PAR-4 levels compared to pre-treatment plasma levels in patients with resectable solid     tumors.   "
80500|NCT02232230|"     Radiation in combination with Provenge based immunotherapy may improve outcomes seen on     imaging as well as immunologic monitoring. This study will assess the effect of radiation     therapy to augment anti-tumor responses from immune therapy with Provenge.   "
80539|NCT02231723|"     This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered     in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU     and leucovorin.   "
80540|NCT02231710|"     The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells     infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety     of AP1903 on day 7 to prevent GVHD.   "
80482|NCT02232464|"     Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset     neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive     deficits may last to adulthood. Our previous studies, like western results, have shown that     children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways     and impaired brain activity in frontoparietal network. However, there is lack of data with     regards to whether adults with ADHD also demonstrate structural and functional     disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls     without ADHD in Asian population and no study has been done to correlate a wide range of     executive functions with the connectivity of these two networks.      Specific Aims:        1. to compare the executive functions, and structural and functional connectivity in          frontostriatal and frontoparietal circuitries between adults with ADHD and healthy          controls without ADHD;        2. to correlate the data from structural and functional connectivity, executive functions,          and ADHD core symptoms stratifying by the ADHD and controls; and        3. to explore other circuitries that may involve in ADHD by using whole brain tractography          analyses.   "
80483|NCT02232451|"     The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip     for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk     patients.   "
80484|NCT02232438|"     At present, there are no established treatments for depression or anxiety in adolescents with     cancer, creating an important clinical and research gap. Fortunately, there is now     substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed     and anxious adolescents in the general population.   "
80485|NCT02232425|"     The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong     premature ejaculation.   "
80486|NCT02232412|"     Critically ill patients are frequently transfused with red blood cell (RBC) units with the     predominant intention to increase arterial oxygen content and thus oxygen delivery to the     tissues.      To date, RBC transfusions have been proven effective in patients with profound anaemia or     circulatory shock. However, the impact of the storage process and the so-called storage     lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding     tissue oxygenation are much debated at present. Alterations of RBC physiology have been     comprehensively described ex vivo. Reduced deformability, increased adhesiveness and     aggregability of stored RBC impair their rheological properties; anaerobic cellular     metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP)     increases oxygen affinity and impairs oxygen release to the tissues.      This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen     saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near     infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might     require RBC transfusion. The monitoring is continued for the time of transfusion and the     hours afterwards.   "
80487|NCT02232399|"     The aim of the study is to assess the ability of Levosimendan to reduce the postoperative     acute kidney injury in pediatric patients undergoing surgery for congenital heart disease     (CHDs). Young children, between the age of 1 to 12 months, with congenital heart disease in     need of elective heart surgery will be included in this study.      The trial will contain two study groups, 35 patients in each. One group will receive     Levosimendan and the second group will receive Milrinone as a heart muscle-strengthening     agent during and after the operation. Milrinone is currently used as the drug of choice in     many pediatric cardiac surgery centers. It remains to see if Levosimendan can exert a kidney     protecting function in addition to its heart muscle-strengthening properties.      The primary objective of this study is to investigate the preventive effect of Levosimendan     on postoperative acute kidney injury in pediatric patients undergoing surgery for their CHDs.     Creatinine levels postoperatively will be the primary endpoint. Creatinine, the common marker     of kidney injury, will be measured daily.      The treatment with Levosimendan or Milrinone will be started during the operation (after     initiation of cardiopulmonary bypass) and will last 24 hours. Blood samples will be obtained     at six occasions perioperatively. Patients will be followed 4 days after termination of     treatment (totally 5 days).      The duration of study will be 30 days (24 hours treatment + 4 days follow up +     30-days-mortality registration).      Creatinine is the primary outcome in this study. Inflammatory biomarkers and other relevant     biomarkers will comprise the secondary outcome variables.   "
80489|NCT02232373|"     The purpose of the study is explore the issues that relate to testing a particular dietary     treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with     which to compare it. In this trial the investigators will look at its effect on symptoms of     people with persistent disturbance in their bowel pattern 3 months after an intestinal     infection with Campylobacter.      The investigators will also look at the changes in gut bacteria that occur with the diet.   "
80490|NCT02232360|"     The purpose of this study is to determine effects of combination therapy with rosuvastatin     and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary     lesions with intermediate stenosis in patient with coronary artery disease, compared with     rosuvastatin alone therapy.   "
80491|NCT02232347|"     The objective of the study is to compare the effects of 48 hours ketamine infusion versus     sufentanil infusion on brain glutamate concentrations measured with microdialysis after     traumatic brain injury.      We hypothesize that ketamine infusion will decrease high glutamate values faster than     sufentanil.   "
80520|NCT02231970|"     Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations     achieved by surgical sleeve gastrectomy.      The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the     treatment of patients with obesity   "
80533|NCT02231801|"     This observational study aims to monitor the vital sign changes in both mother and baby that     occur during kangaroo care in preterm infants and to investigate any potential correlations     between maternal measurement values and those of the infant. The purpose of this     observational study is to look for a method to track the earliest responses that could,     theoretically, be considered as 'social responses' in hopes of providing developmental     interventions earlier to at-risk infants.   "
80591|NCT02229994|"     The purpose of this study is the psychometric validation of a self-administered dyspnea     questionnaire, usable in clinical practice in order to assess dyspnea and its impact on     patients with chronic respiratory diseases.   "
80492|NCT02232334|"     Global osteopathic manual treatments will decrease the severity score of the Gastroparesis     Cardinal Symptom Index tool of patients with idiopathic gastroparesis.      In this longitudinal controlled pre-test post-test group design, subjects with idiopathic     gastroparesis (IG) will be utilized to see if global osteopathic manual treatments can     decrease their symptoms. Patients with IG suffer from varying degrees of nausea, vomiting and     abdominal pain secondary to delayed gastric emptying. There is no known cause for people     suffering from IG.      According to the power analysis, the population will be utilized as the experiment group and     the control group. The measuring tool to be used is the Gastroparesis Cardinal Symptom Index     (GCSI) which is the most widely used symptom score questionnaire for gastroparesis. The     subjects in the population will each fill out the GCSI initially and again after an two (2)     week period to measure their symptoms during a control period. The same subjects will then be     treated with global osteopathic manual treatments one (1) treatment every two (2) weeks for     four (4) weeks (day 1, 14, and 28). The GCSI will be filled out on the day of the first (1st)     treatment (which is the last day of the control period) and then two (2) weeks after the last     treatment (day 42). In order to reject the null hypothesis, with a p value of < 0.05 and a     power of 0.8, a minimum of ten (10) subjects in the treatment group is required with a     treatment effect of 1 or more. A 'Treatment effect of 1' is defined by Cohen's d, where d =     mean difference/standard deviation.      It is expected that the results will show improvement of symptoms through the data collected     from the GCSI questionnaires in the treatment group. The results of this study could be     significant and contribute to the osteopathic community validating the effectiveness of     traditional osteopathic manual therapy as well as giving non-invasive options to people     suffering from the disease since those who struggle with it have minimal treatment     options--medicines with significant side effects, full or total stomach removal or gastric     electrical stimulator implants.   "
80493|NCT02232321|"     Objectives To investigate the effect of achieving minimal disease activity (MDA) using a     protocolized treatment strategy on the progression of subclinical atherosclerosis and     arterial stiffness in psoriatic arthritis (PsA) patients.      Hypothesis Effective suppression of inflammation in patients who can achieve MDA will have     less progression of subclinical atherosclerosis and arterial stiffness then patients who     cannot achieve MDA by means of a standardized treatment algorithm aiming at MDA.      Design and subjects One hundred consecutive PsA patients will participate in this 2-year     prospective, hospital-based, cohort study.      Interventions All participants will receive 2-year tight-control treatment. Treatment will be     adjusted according to a standardized protocol based on the European League Against Rheumatism     (EULAR) recommendation and the Hong Kong guideline on the use of biologics every 4-monthly     aiming at MDA.      Study instruments Carotid intima-media thickness (IMT) will be measured using high-resolution     ultrasound. Arterial stiffness is measured using pulse wave velocity (PWV) by a dedicated     tonometry system and augmentation index (AIx) by the SphygmoCor device.      Main outcome measures and analysis The main outcome measure is the change in IMT over a     period of 2 years comparing between patients who achieve MDA at 12 months (MDA group) to     those who cannot achieve MDA (non-MDA group). Secondary outcomes include differences in the     changes in AIx and PWV over 2 years between the 2 groups. Comparisons of the changes in IMT,     AIx and PWV over 2 years between the MDA and non-MDA groups will be performed.   "
80494|NCT02232308|"     To assess if oral nizatidine or lisinopril alone and in combination will increase heme     oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy     subjects.   "
80495|NCT02232295|"     The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor     functions and quality of life in patients with stroke that was conducted in two centers in     india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary     outcome measure was quality of life at 6 weeks.      Research Hypothesis: There would be significant effect of GMI on Upper limb motor functions     and quality of life in patients with stroke.   "
80497|NCT02232269|"     Hypertension affects an estimated 1.5 billion people world-wide and is a chief contributor to     death, stroke, congestive heart failure, kidney disease, coronary artery disease and     dementia. A number of important causal environmental factors have been identified and include     excessive salt or alcohol consumption, physical inactivity, inadequate fruit, vegetable and     potassium intake and obesity. Although there have been significant improvements in     management, a high percentage of patients still do not achieve target blood pressures.      Coffee is a popular beverage globally and elevates blood pressure variably among individuals.     Customers in the United States comprise more than half of the population over the age of 18     years, consume an average of 1 cup (typical size: 270 ml) of coffee three times per day and     spend an estimated $ 40 billion on the purchase of it each year. A major active constituent     in coffee is caffeine, which is the most widely used pharmacological substance in the world.      Drug therapy plays a major role in the management of hypertension. Concomitant intake of     coffee is likely substantial. However, the interaction between coffee or caffeine and blood     pressure lowering drugs has been assessed in only a few clinical studies conducted more than     two decades ago. Moreover, it appears to have the potential to confound the routine drug     management of hypertension.      This clinical investigation reports the actions of a customary amount of coffee on the     circulatory effects and blood concentrations of felodipine, a drug belonging to a class of     drugs commonly used to treat hypertension. Application of results from this study to clinical     practice has the possibility to improve the management of hypertension.   "
80498|NCT02232256|"     California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild     sedative and/or sleep aid. However there are no human clinical trial data to support its use.     Sleep disturbances are a well-recognized component of chronic pain, and lead to additional     social withdrawal, greater pain and worsening depression. Most hypnotics available either     place the patient at further risk (e.g. benzodiazepines combined with opioids increase the     risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime     somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in     Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid     adverse effects while improving sleep. An open-label clinical trial was performed to obtain     preliminary safety and efficacy information of California poppy. This trial was approved by a     central ethics review board. The study results showed that California poppy, can be used as a     co-analgesic to provide additional analgesia and/or sleep improvement to the patient.     Patients who are referred to the clinic will be asked to complete a few short questionnaires     at every visit and on monthly basis respectively. This data, in addition to the usual     follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain     Disability Index, Short-form Health Survey-12v2) and general demographic and medical     information will be used to assess California Poppy's effectiveness on patients   "
80541|NCT02231697|"     This retrospective medical chart review (RECENSUS) of approximately 100 XLMTM patients (with     a goal to obtain 50 deceased and 20 living records) will provide further knowledge about the     clinical manifestations and recorded medical management of XLMTM and potentially inform the     design of future therapeutic intervention studies.   "
80501|NCT02232217|"     The purpose of this study is to conduct a randomized controlled trial (RCT) to evaluate the     efficacy of brief cognitive behavioral treatment for child sleep (CBTcs) to improve sleep in     an important high-risk population, overweight/obese (OV/OB) youth with behavioral sleep     disorders. OV/OB youth with behavioral sleep disorders and their parent(s) will be randomly     assigned to 8 sessions of either CBTcs or an Educational Control (EC). CBTcs will address     behavioral sleep issues in children; EC will address sleep and dietary education and general     coping strategies. Child sleep (total wake time, total sleep time, bed/wake times), height,     weight, physical activity, dietary intake, quality of life (QOL), fatigue, and daytime     sleepiness will be assessed at baseline, post-treatment, and 3-month follow-up. It is     hypothesized the children in the CBTcs will experience greater improvement in sleep than     children in the EC.   "
80502|NCT02232204|"     This is a single-center, randomized controlled trial study design. Enrolled participants have     a cardiovascular condition for which they are undergoing implantable cardioverter     defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a     behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment     intervention period lasted 4 weeks with a telephone booster session administered at 3 month     follow-up. The objective of the study is to examine the impact of a brief therapy combining     established behavioral approaches to treating insomnia with novel components to target     negative cognitions and anxieties associated with cardiac disease and ICD implantation.     Primary patient outcomes include sleep, psychological functioning, daytime functioning,     cardiac functioning, cognitive performance, and ICD adjustment.   "
80503|NCT02232191|"     Persons without a spleen are susceptible to potentially lethal infections from certain     bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect     against these infections, though they do not so with certainty. Trauma patients who sustain     an injury to their spleen currently have three treatment options available for the treating     surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of     this study is to investigate the antibody response to pneumococcal vaccine in patients     undergoing these modes of therapy.   "
80504|NCT02232178|"     Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy     hernioplasty and assess the relative bioavailability of Xaracoll compared to a local     bupivacaine infiltration.   "
80505|NCT02232165|"     Current guidelines for the clinical management of acute spinal cord injury (SCI) recommend     maintenance of mean arterial blood pressure (MAP) at 85 to 90 mmHg for the first seven days     after SCI as a clinical option. Unfortunately, the medical evidence to support this     recommendation exists only at the clinical case series level (Class III data). Furthermore,     maintenance of sustained systemic hypertension, as per clinical guidelines, may be associated     with risks to the patient via adverse medical events. Given this equivocal evidence, the     investigators group has questioned the merit of sustained induced hypertension following     acute SCI and has previously conducted a randomized, prospective controlled feasibility study     to further examine this issue. This prior pilot study randomized patients with acute SCI to a     spinal cord perfusion pressure (SCPP = MAP - intrathecal pressure (ITP)) target of ≥ 75 mmHg     or to a control group (hypotension avoidance, MAP ≥ 65 mmHg). The primary endpoint measure     was defined as the change in American Spinal Injury Association (ASIA) motor score from     baseline. No difference in the primary outcome was noted at one-year post-SCI in this study.      In light of this pilot data, the investigators hypothesize that maintenance of normotension     (MAP ≥ 65mmHg) is not inferior to induced hypertension (MAP ≥ 85mmHg) for 7 days following     acute SCI. As such, the investigators propose to conduct a Phase III non-inferiority     prospective, randomized clinical trial in acute SCI patients. Subjects will be randomized     into one of two MAP management groups for 7 days; Group 1 will be managed with a target MAP ≥     65 mmHg, while Group 2 will be managed with a target MAP ≥ 85 mmHg. The primary endpoint will     be change in ASIA motor score from baseline at 12 months post injury. A difference of ≤10     ASIA motor points change from baseline between groups will be considered as non-inferiority.     Secondary endpoints will include ASIA sensory score, proportion of patients achieving a one     grade improvement in ASIA impairment scale, quality of life assessment (as measured by     Short-Form-36 [SF-36]) and functional outcome (as measured by the Spinal Cord Independence     Measure (SCIM) and Functional Independence Measure (FIM). These will be measured at baseline,     72 hours and 3, 6 and 12 months from injury. Adverse events will be meticulously recorded.     The information gleaned from this trial will provide valuable information for the acute     treatment of traumatic SCI and will serve the objective of optimizing current clinical     practice and thus maximizing medical and neurological outcome for individuals following acute     traumatic SCI.   "
80506|NCT02232152|"     This pilot phase I trial studies the side effects and best dose of CPI-613 when given     together with fluorouracil in treating patients with colorectal cancer that has spread to     other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by     turning off their mitochondria. Mitochondria are used by tumor cells to produce energy and     are the building blocks needed to make more tumor cells. By shutting off these mitochondria,     CPI-613 deprives the tumor cells of energy and other supplies that they need to survive and     grow in the body. Drugs used in chemotherapy, such as fluorouracil, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Giving CPI-613 with fluorouracil may kill more tumor     cells.   "
80507|NCT02232139|"     The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test     (4CRT) as a measure for recovery of the psychomotor function in patients after general     anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in     general anesthesia, will be randomized to the group with pharmacological anxiolytic     premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients     will be monitored using 4CRT before and after standardized general anesthesia. The reaction     time, measured with 4CRT is the primary outcome parameter of the investigation.   "
80521|NCT02231957|"     There are a growing number of adolescents with chronic medical conditions in the United     States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination     and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination     is also recommended for certain high-risk patients. Limited studies suggest that vaccination     coverage of this population remains sub-optimal. Text message vaccine reminder/recall has     been shown to be effective in increasing uptake of select pediatric and adolescents vaccines,     but has yet to be examined among patients with chronic medical conditions who may also face     unique barriers to vaccination. This intervention aims to implement and evaluate the use of     text message vaccine reminders among urban low-income minority adolescents with chronic     medical conditions. This investigator-initiated study is supported in part by a grant from     the Pfizer Medical Education Group.   "
80522|NCT02231944|"     To compare the first and second recovery assessments on Replenine®-VF and to evaluate     recovery of different batches if patients changed batches during the study.      To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety   "
80523|NCT02231931|"     To investigate the mutual interaction potential of digoxin, furosemide, metformin, and     rosuvastatin when given alone or together as a cocktail, and to investigate the effect of     high doses of metformin or furosemide on pharmacokinetics of the other cocktail compounds   "
80508|NCT02232126|"     In response to Program Announcement (PA)-09-164, NIH Exploratory/Developmental Research     Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work     Intervention Focused on Transitions among at-risk older adults following hospital discharge     to home. This study is drawn from several observations. First, transitions between care     settings create elevated risk for poor outcomes and for readmission among older adults     leaving the hospital for home largely due to fragmented care and poor communication. Next,     while few studies exist that test methods to improve transitions, those available are largely     medically focused, using a nurse or advanced practice nurse in their approach. Although     evidence exists to support the effectiveness of these models, few have been replicated and     none have been integrated into standard health care practice. This may be attributed to     several factors including the availability of the needed staff, the lack of existing     structures to support these roles, and the costs of implementing these interventions.     Finally, a social work driven intervention may provide a replicable mechanism for bridging     medical care, addressing psychosocial needs as well as medical needs, and improving linkages     with community services while reducing care duplication. This study aimed to test a     structured social work transition intervention model to reduce rates of hospital readmission     and medical service use while improving patient satisfaction with the care transition     process. A randomized pilot study was used to test a social work transitions model designed     to improve care provided to frail older adults being discharged from the hospital to return     to the community. Eligible patients consenting to participate (n=181) were randomly assigned     to either the social work transitions model intervention or usual care. This project was     conducted at Huntington Hospital, a 525-bed, nonprofit, community hospital located in     Pasadena, California. In an average year, Huntington Hospital has approximately 10,000 older     adults discharged from their facility, 44% of who are 80 years old or older. Those randomized     to the intervention arm received up to six sessions from the social worker, at least one     provided in the home. The social work intervention was designed to overcome common problems     following hospital discharge including medication review, discussion and planning around     discharge instruction, assistance in scheduling follow up appointments, assessments of     psychosocial and other support service needs and provision of linkages to address those     needs. Outcomes were measured three and six months following arrival at home, with an interim     measure of satisfaction at 10 days following arrival at home, with measures including patient     level of depression, pain, physical functioning, self-efficacy with disease management, and     medical service use.   "
80509|NCT02232113|"     The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose     interval and the survey for influence factors:      We aim to evaluate a better clinical response which can be achieved by different dosing     interval of a fixed dose of CERA. We expect this study can determine the dosing schedule with     better clinical response to CERA and identify the associated factors predicting the     cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.   "
80510|NCT02232100|"     Chronic musculoskeletal pain is a complex medical condition associated with significant     distress, disability, and reduction in quality of life. Research has shown that patients with     chronic musculoskeletal pain demonstrate attentional biases towards pain-related information.      The purpose of this study is to determine whether internet-delivered attentional bias     modification, which aims to implicitly train attention away from pain-related information,     has beneficial effects upon pain and pain-related distress in patients with chronic     musculoskeletal pain.      Participants will be randomised to either an attentional training condition, or to a     no-training placebo condition. The primary outcome measures are pain intensity and pain     interference, and secondary outcome measures include anxiety, depression, pain-related fear     and sleep problems.      It is hypothesized that participants receiving internet-delivered attentional bias     modification will show significantly greater reductions in pain and pain-related distress     compared to participants receiving placebo training.   "
80511|NCT02232087|"     The purpose of this study is to test the body's response to several doses of two different     inhalation products in healthy volunteers.   "
80512|NCT02232074|"     The investigators plan to compare standard patient navigation with an enhanced navigation     partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal     needs of newly diagnosed cancer patients in addition to other barriers to care leads to     better clinical outcomes.   "
80513|NCT02232061|"     This study will evaluate if patients who had a serious cardiovascular event upon initiation     of fingolimod are at risk to delevop long term other cardiovascular events   "
80514|NCT02232048|"     Patients hospitalized in internal medicine departments are given corticosteroid treatment     according clinical indications. Patients receive treatment at different dosage levels and in     different preparations according to clinical indications. This study will investigate how     corticosteroids effect the heart and specifically, longitudinal strain.   "
80515|NCT02232035|"     Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to     increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and     asphyxia and requires early detection and appropriate clinical response. The risks for     complications of prolonged labour are much greater in poor resource settings. Active     management of labour versus physiological, expectant management, has shown to decrease the     occurrence of prolonged labour. Administering sedatives during labour could also lead to     faster and more effective dilatation of the cervix. Interventions to shorten labour, such as     sedatives, can be used as a preventative or a treatment strategy in order to decrease the     incidence of prolonged labour. As the evidence to support this is still largely anecdotal     around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane     Database of Systematic Reviews 2012, CD009223.pub2.)      Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.   "
80516|NCT02232022|"     The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation     (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial     fibrillation.   "
80517|NCT02232009|"     This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for     imaging viable neonate and infant populations. This MR system has a smaller size and design     features that may make it more feasible to locate the system in close proximity to care areas     for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical     neonatal intensive care units (NICUs) and other infant and neonatal care departments.   "
80518|NCT02231996|"     CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the     subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are     diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine,     including clinical feature, laboratory data and genetic information. we aim to find out     clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus     further improving the level of diagnosis and treatment for CGD.   "
80519|NCT02231983|"     Severe combined immunodeficiency (SCID), a rare primary immunodeficiency dieases (PID), is     poorly characterized in mainland China. We meant to explore the patients with SCID refered to     our hospital and summarize their clinical manifestations and genetic features.   "
80524|NCT02231918|"     Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a     single dose orally (p.o.) in pediatric patients with the diagnosis of RLS   "
80526|NCT02231892|"     Background:      - Brain stimulation called repetitive transcranial magnetic stimulation (rTMS) may help     people quit drugs. Researchers want to study how it works in healthy people first.      Objective:      - To learn how to use rTMS to stimulate a brain area and to see how it affects brain function     and thinking.      Eligibility:      - Healthy, right-handed adults ages 18-55.      Design:        -  Participants will be screened under another protocol.        -  They will have 4-11 study visits.        -  To start each visit, participants will have:        -  Physical exam.        -  Urine sample.        -  Breath tests for alcohol and cigarette smoke.        -  Questions about drug use and medications.        -  Visit 1: participants will have:        -  Single TMS pulses on the head to determine the right strength. They will wear earplugs          and a cap. A wire coil will be placed on the head and an electrical current will go          through it. Participants may perform simple muscle movements. They will repeat the          procedures wearing another coil, in a helmet.        -  A few TMS pulses to show how rTMS feels.        -  A practice thinking task, maybe in a scanner that looks and sounds like a magnetic          resonance imaging (MRI) scanner but does not take pictures. The MRI scanner is a metal          cylinder surrounded by a strong magnetic field. The participant will lie on a table that          slides in and out of the cylinder.        -  They may have a real MRI scan.        -  Visits 2-11, participants will:        -  Complete two questionnaires.        -  Get varied rTMS stimulation. Their heart rate and blood pressure may be monitored.        -  Have their vital signs checked.        -  They may perform thinking tasks at a computer, in a mock scanner, or in an MRI scanner.          They may just lie still in the MRI scanner.   "
80527|NCT02231879|"     Background:      - WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is a rare     disease. It can cause cancers, infections, and warts. Researchers want to see if a drug     called plerixafor can treat WHIMS.      Objective:      - To compare plerixafor versus granulocyte colony stimulating factor (G-CSF) for preventing     infections in people with WHIMS.      Eligibility:      - People ages 10 75 with WHIMS who have a CXCR4 gene mutation.      Design:        -  Participants will be screened with a medical history, physical exam, and blood and urine          tests. They may have heart and spleen tests and body scans. They may have samples of          skin or warts taken. Researchers may take photographs of warts.        -  Participants will start twice daily self-injections of G-CSF. Their doctors will decide          the dosage.        -  Initial Period (4 12 weeks)        -  Participants will:        -  continue the injections and their usual antibiotics and/or immunoglobulin        -  have blood drawn        -  keep a daily health diary        -  Participants will visit the clinic for 2 days without injections.        -  Adjustment Period 1 (8 weeks):        -  Participants will:        -  continue twice daily injections from home        -  continue the daily health diary        -  have blood tests every 2 weeks.        -  Treatment Year 1:        -  Participants will        -  receive either plerixafor or G-CSF injections twice daily        -  continue the health diary        -  have blood tests every 2 months        -  visit the clinic about every 4 months        -  At the end of year 1, participants will visit the clinic for an evaluation. They will          switch to the other study drug. They will have an 8-week adjustment and 1-year treatment          period.        -  At the end of year 2, participants will visit the clinic to complete their injections          and go back to their previous G-CSF regimen. Participants will continue their daily          health diary and have blood tests for 5 6 months.   "
80528|NCT02231866|"     Background:      - Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the     largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is     impossible for someone to get an Ebola infection from this vaccine.      Objectives:      - To see if an Ebola vaccine is safe and to study immune responses to it.      Eligibility:      - Healthy adults ages 18-65.      Design:        -  Participants will be screened through a separate protocol.        -  Participants will receive the vaccine injection by needle and syringe into an upper arm          muscle. - Participants will stay at the clinic for 3 hours after the injection.        -  About 2 days later, participants must speak with clinic staff about how they are doing.        -  Every day for 7 days after the injection, participants will record their temperature and          symptoms and look at the injection site. They will get a thermometer and a ruler to          measure any redness or swelling. They will report any side effects.        -  In the first 2 months in the study, participants will have at least 6 clinic visits and          1 phone call. They will have at least 3 other visits over the next 9 months.        -  At each visit, participants will be checked for health changes or problems since their          last visit. They will be asked how they feel and if they have taken any medicine. Blood          will be drawn at most visits. Urine samples may be collected.   "
80529|NCT02231853|"     Allogeneic hematopoetic stem cell transplantation (SCT) is frequently complicated by life     threatening viral reactivation. Conventional antiviral therapy is suboptimal for     cytomegalovirus (CMV), adenovirus (AdV) and Epstein-Barr virus (EBV) and nonexistent for BK     virus (BKV). An alternative approach to prevent viral reactivation is to infuse     virus-specific cytotoxic T cells (CTL) prepared from the donor early after SCT. Such     multivirus-specific CTL cells (MVST) have been successfully used in a number of centers to     prevent or treat CMV, Ad and EBV. Activity of BKV-reactive cells has not been studied. Multi     virus-specific T cells (MVST) are donor lymphocytes that are highly enriched for viral     antigens and expanded in vitro before infusion into the transplant recipient. Viral     reactivation is a particular problem inT cell depleted SCT. Median time to CMV reactivation     is estimated as 28 days post T-depleted transplant, but infusion of MVST within the immediate     post-SCT period has not been previously studied. This protocol will be the first of a planned     series of cellular therapies to be layered on our existing T lymphocyte depleted transplant     platform protocol 13-H-0144.      The aim of this study is to determine the safety and efficacy of very early infusion of MVST     directed against the four most common viruses causing complications after T-depleted SCT.     GMP-grade allogeneic MVST from the stem cell donor will be generated using monocyte-derived     donor dendritic cells (DCs) pulsed with overlapping peptide libraries of immunodominant     antigens from CMV, EBV, Ad, and BKV and expanded in IL-7 and IL-15 followed by IL-2 for 10-14     days. A fraction of the routine donor leukapheresis for lymphocytes obtained prior to stem     cell mobilization will be used to generate the MVST cells. MVST passing release criteria will     be cryopreserved ready for infusion post SCT.      Eligible subjects on NHLBI protocol 13-H-0144 will receive a single early infusion of MVST     within 30 days (target day +14, range 0-30 days) post SCT. Phase I safety monitoring will     continue for 6 weeks. Viral reactivation (CMV, EBV, Ad, BK) will be monitored by PCR by     serial blood sampling. The only antiviral prophylaxis given will be acyclovir to prevent     herpes simplex and varicella zoster reactivation. Subjects with rising PCR exceeding     threshold for treatment, or those with clinically overt viral disease will receive     conventional antiviral treatment. Patients developing acute GVHD will receive standard     treatment with systemic steroids. These patients are eligible for reinfusion of MVST when     steroids are tapered.      The clinical trial is designed as a single institution, open label, non-randomized Phase I/II     trial of MVST in transplant recipients, designed as 3-cohort dose escalation Phase I followed     by a 20 subject extension Phase II at the maximum tolerated dose of cells. Safety will be     monitored continuously for a period of 6 weeks post T cell transfer. The primary safety     endpoint will be the occurrence of dose limiting toxicity, defined as the occurrence of Grade     IV GVHD or any other SAE that is deemed to be at least probably or definitely related to the     investigational product. The primary efficacy endpoint for the phase II will be the     proportion of CMV reactivation requiring treatment at day 100 post transplant. Secondary     endpoints are technical feasibility of MSVT manufacture, patterns of virus reactivation by     PCR, and clinical disease from EBV, Ad, BK, day 100 non-relapse mortality.   "
80530|NCT02231840|"     Background:      - About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow     people that have alcohol problems and want treatment, as well as those who do not want     treatment and healthy volunteers. They also want to gather information on people with and     without alcohol problems, including information on genes and biological processes in the     body.. This will help them better understand, prevent, and treat alcohol problems.      Objective:      -To look at a broad range of traits in people who are healthy people and people with alcohol     problems. To study them for potential eligibility for other research protocols conducted at     the NIH Clinical Center.      Eligibility:        -  Adults age 18 and older.        -  Not being pregnant or imprisoned.      Design:        -  Participants will have a physical exam. They will answer questions about their health          and alcohol and drug use. They will have an electrocardiogram to check their heart. They          will have blood, urine, and breath alcohol tests.        -  Participants without alcohol problems, or who have them but do not want treatment, can          sign the second consent for screening and research.        -  Participants that have alcohol problems and want treatment will be treated at the NIH          Clinical Center. They will be offered to sign the second consent at a later time.        -  Participants may join an inpatient treatment and detox program. It could last up to 6          weeks. Or they may join an outpatient program. Some may do both.        -  After discharge, participants may be called and asked questions about their drinking and          health.        -  If participants sign the second consent, they:        -  will complete paper- and computer-based questionnaires.        -  will give blood samples.        -  may have a brain scan using magnetic resonance imaging. They will lie on a table that          slides in and out of a cylinder that takes pictures. The machine makes loud noises. They          will get earplugs.   "
80531|NCT02231827|"     Gait and balance disorders are important public health problem necessitating studies to try     to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance     during quiet standing (posturography). Nevertheless, falls occurred predominantly during     gait, and rarely during quiet standing. We have developed a tool to measure balance during     gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the     vertical velocity of the CM recorded with a force plate.      In previous studies, we have shown that the braking of the CM was a physiological and a     active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM     measured on a force plate provide an important intra-individual variability.      The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The     primary goal of this study is to compare intra-individual variability of the braking of the     CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in     healthy subjects.   "
80532|NCT02231814|"     This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease     Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while     the other half will receive the CDED and a liquid diet formula, for 24 weeks.   "
80534|NCT02231788|"     The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP     Control Compared with Telmisartan Monotherapy   "
80549|NCT02231593|"     The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated     comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported     Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will     determine the potential use of a finalised operational version for patient classification in     clinical practice and studies.      In addition, this study intends to carry out a qualitative evaluation of the acceptability of     SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and     usefulness of the tool in practice.   "
80550|NCT02231580|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of BN82451B versus placebo after oral administration twice daily (bid) for     28 days in patients with Huntington's Disease (HD).   "
80551|NCT02231567|"     The purpose of the study is to evaluate the effectiveness of an approach based on     neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution     involves the use of higher cognitive functions (attention, memory, language), not required in     a traditional approach proprioceptive, in order to obtain a more complete and long-lasting     recovery.   "
80552|NCT02231554|"     The purpose of this study study is to determine whether the Feldenkrais method is effective     on pain control, functional recovery and quality of life in patients with chronic low back     pain by comparing it with a Back School program.   "
80553|NCT02231541|"     The purpose of the study is to determine the effectiveness of treatment with very low     frequency electromagnetic fields on the reduction of pain in patients with fibromylgia,     disease presenting with widespread musculoskeletal pain usually associated with other     symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.   "
80554|NCT02231528|"     The GPS system would simplify the technical implementation of central venous catheter under     ultrasound guidance. We can assume that the introduction of deep venous pathways (as a     reference, the internal jugular) will be faster, and this, whatever the level of expertise.     By checking this hypothesis, this technique could be applied to much less frequent situations     establishment of difficult central venous catheters (hemodynamic status precarious,     hypovolemia, or cardiac arrest).      The main objective of this study is to evaluate the time savings provided by the ultrasound     assisted GPS guidance for installing central venous catheters in the internal jugular.     Central venous catheters are inserted in the operating room under conditions scheduled in     advance that is to say outside emergency. The installation time for the central venous     catheter is compared with that obtained by using the ultrasound machine without the GPS guide     (conventional technique).   "
80555|NCT02231515|"     A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of     selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle     glaucoma.   "
80574|NCT02231255|"     Documentation of the effect of an direct or overlapping switch from another dopamine agonist     to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the     reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the     switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic     Parkinson's disease under routine conditions   "
80575|NCT02231242|"     The purpose of this study is to determine whether the infusion of intrathecal autologous bone     marrow total nucleated cells would improve the neurologic evolution of pediatric patients     with quadriparetic cerebral palsy.   "
80556|NCT02231502|"     The purpose of this study is to establish to what extent innovations in food production     techniques may facilitate retention of bioactive compounds in healthy individuals.      The study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma     concentration and urinary excretion levels of a range of bioactive compounds will be assessed     over a 24 hour period following intake of either a vegetable based convenience food, or a     minimally processed meal containing the same vegetable materials.      To do this, 20 healthy volunteers will attend two assessment days (and a follow-up assessment     at +24hr) and will provide blood and urine samples, which will be collected at biologically     relevant times over the 24 hour period. In this cross-over study, each meal will be eaten on     separate days, with a wash-out period of at least 1 week between assessments.   "
80557|NCT02231489|"     The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral     dose of capsule (reference) versus tablet (test) in healthy participants.   "
80558|NCT02231463|"     In 50 Patients who are undergoing a planned surgical procedure which require a central venous     catheter the diameter of the subclavian vein is measured by ultrasound under 6 different     conditions.   "
80559|NCT02231450|"     The purpose of this study is to assess the impact of mild to moderate hepatic impairment on     the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054   "
80560|NCT02231437|"     The aim of this post-marketing surveillance is to obtain further information about the     tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive     respiratory tract disease under conditions of daily practice   "
80561|NCT02231424|"     The aim of this postmarketing surveillance is to obtain further information about the     tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic     obstructive respiratory tract disease under conditions of daily practice   "
80562|NCT02231411|"     The purpose of this study is to examine whether providing ventilation during delayed     umbilical cord clamping provides greater placental transfusion and improved hemodynamic     transition at birth.   "
80563|NCT02231398|"     This study is looking at the relationship between experiences during pregnancy and     cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the     approximately 10,000 women who were enrolled and followed over the course of their first     pregnancy in another study.   "
80589|NCT02231060|"     The primary objective of HOPE is to improve the accuracy of outcome prediction in     anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some     of the existing methods used for this purpose (e.g. somato-sensory evoked potentials). HOPE     is the first multicenter prospective cohort study on coma prognosis to control for the effect     of a possible self-fulfilling prophecy at the ICU and to cover the acute and     neurorehabilitation phases with a long-term follow-up longer than the usual three or six     months.   "
80564|NCT02231385|"     The purpose of this study is to compare the additional diagnostic yield obtained by using the     acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.      Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be     recruited to the study and randomized to one of two groups. Each enrolled subject will     undergo two back-to-back procedures limited to the examination of the right colon.      Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon     has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from     cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B     (control group) will undergo a second examination of the right colon without acid acetic and     within the same frame-time.      Results from the two groups will be analyzed and compared, with primary outcome measures     being detection rates for serrated lesions. Secondary outcome measures will include adenoma     detection rate in the right colon or other locations, characteristics of polyps detected,     including size and histological results.      Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected     adverse events. Clinical results will be analyzed using various statistical measures of     significance.   "
80565|NCT02231372|"     Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for     inhalation in patients with chronic obstructive airways disease in daily practice   "
80566|NCT02231359|"     Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for     inhalation in patients with chronic obstructive airways disease in daily practice   "
80567|NCT02231346|"     New perceptions about handling and patient satisfaction of the everyday use of Berodual®     Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease     (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual®     Respimat®   "
80568|NCT02231333|"     Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily     outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and     so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the     future. It is a spectrum of hepatic pathology, ranging from simple steatosis,     steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of     disease where steatosis is accompanied by hepatocyte injury as well as infiltration of     inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis.     NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out     of which 49 RCTs have been done till date to define the appropriate treatment of nonalcoholic     steatohepatitis. However, still a controversy and no recommended treatment available till     date. Recently published PIVENS trial has shown that Vitamin E has proven benefit in NASH.     Other trials have also shown that pentoxiphylline has shown benefit in the form of     histological improvement and biochemical improvement in the form of liver enzymes. Role of     SAMe has been studied in alcoholic liver disease and showed to improve in both biochemical     and histological features. However the usefulness of SAMe in NAFLD is not known till now.     Hence this study has been designed.   "
80569|NCT02231320|"     New perceptions about handling and patient satisfaction of the everyday use of Berodual®     Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further     knowledge should be attained about the tolerability of Berodual® Respimat®   "
80570|NCT02231307|"     The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in     reducing birch allergy induced symptoms and birch allergy medication usage.   "
80571|NCT02231294|"     Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability     in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions   "
80572|NCT02231281|"     The purpose of this study is to assess the ability of the early initiation of cART or cART in     combination with autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion to achieve a     post-treatment control among treatment-naïve acute HIV-infected adults.   "
80576|NCT02231229|"     French guidelines currently recommend to initiate a 4-drug containing regimen associating     isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol     (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind     routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of     primary resistance to INH. Hence, early detection of resistance to INH and RIF using     molecular testing in Mycobacterium tuberculosis could allow early adaptation of     antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and     PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth     susceptibility testings.      the duration of treatment is 6 months or 12 months.   "
80577|NCT02231216|"     Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is     responsible for an increase in quality of life related to nasal obstruction when compared to     no intervention in rhinoseptoplasty inferior turbinate?        -  Population: patients eligible for functional rhinoseptoplasty and / or aesthetic        -  Intervention: surgery, turbinectomy of inferior turbinates        -  Comparison: the absence of intervention in inferior turbinates        -  Primary endpoint: Quality of life related to nasal obstruction   "
80578|NCT02231203|"     Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism     that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled     inflammatory response, however may lead to catabolism, tissue damage and organ failure.     Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of     the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells,     they trigger intracellular signalling pathways that result in a less pro-inflammatory     response. They modify gene and protein expression, modulate membrane protein activity and act     as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by     mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve     erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and     wound healing.      The investigators hypothesize that the perioperative administration of intravenous omega-3     fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby     reducing the postoperative inflammatory response and improving erythrocyte function in     patients undergoing colorectal surgery.   "
80607|NCT02229786|"     Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol,     and placebo in patients with painful gastric or intestinal spasms.   "
80579|NCT02231190|"     As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from     unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study     is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after     unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or     placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863     on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1     subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral     doses of GSK1278863/placebo in total. The first dose will be administered immediately after     completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be     housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge.     After enrolment of approximately 30 subjects, enrolment will be paused and planned interim     analysis will be performed to decide whether to terminate enrolment/study, continue dosing or     to reduce the dose to 5 milligrams (mg).   "
80580|NCT02231177|"     The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at     steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL     plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at     steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg     tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.      The secondary objectives were to compare the safety and tolerability (adverse events, 12-lead     electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and tiotropium     bromide when administered as fixed dose combination or as single-agent therapy.   "
80581|NCT02231164|"     The present trial will investigate the efficacy and safety of nintedanib in combination with     docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV     or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based     chemotherapy.   "
80582|NCT02231151|"     The investigators will look at how accurate pediatric healthcare workers are at judging     quality of Cardiopulmonary Resuscitation, by observation of the chest compressions, and if     they are more accurate at a certain position near the patient. The investigators will do this     by having participants fill out a survey about the quality of the Cardiopulmonary     Resuscitation in several recorded resuscitation scenarios.   "
80583|NCT02231138|"     Huangkui Capsule is a single medicament of traditional Chinese medicine consists of     Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this     study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic     kidney disease in large scale samples with long time take.   "
80584|NCT02231125|"     -IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is     a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has     been widely used to treat kidney disease. The purpose of this study is to evaluate the safety     and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with     long time take.   "
80585|NCT02231112|"     It is well known fact that postoperative whole breast radiation therapy (RT) in left breast     cancer patient can cause cardiac problem according to the exposed dose. In the several     studies in other countries, it was repeatedly showed that RT on prone position can reduce     cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position     in RT is not studied in the Korean women have relatively small breast. The investigators     planned this study to evaluate the real efficacy of prone position in Korean breast cancer     treated with RT.   "
80586|NCT02231099|"     Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of     pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for     improvement of the surgical techniques currently used. Placement of a mesh aims at reducing     the recurrence rate.      In this study the investigators compare the effectiveness of the Tension free Vaginal mesh +     Monocryl with standard vaginal prolapse surgery without mesh.   "
80587|NCT02231086|"     This study aims to determine the oncological effectiveness of adjuvant HIPEC, using     intraperitoneal oxaliplatin with concomitant i.v. 5-FU/LV, following a curative resection of     a T4 or intra-abdominally perforated Colon cancer in preventing the development of peritoneal     carcinomatosis in addition to the standard adjuvant systemic treatment.      Hypothesis:      The hypothesis is that adjuvant HIPEC preceding routine adjuvant systemic therapy using i.p.     oxaliplatin with concomitant i.v. 5-FU/LV following a curative resection of a T4 or     intra-abdominally perforated colon cancer reduces the development of peritoneal     carcinomatosis in comparison to standard adjuvant systemic treatment alone.   "
80588|NCT02231073|"     There is emerging research detailing the relationship between balance/gait/falls and     cognition. Imaging studies also suggest a link between structural and functional changes in     the frontal lobe (a region commonly associated with cognitive function) and mobility. People     with Parkinson's disease have important changes in cognitive function that may impact     rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal     lobe connections with the basal ganglia and brainstem posture/locomotor centers are     responsible for postural deficits in people with Parkinson's disease and play a role in     rehabilitation efficacy. The purpose of this study is to 1) determine if people with     Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively     challenging mobility exercise program and 2) determine if cognition and brain circuitry     deficits predict responsiveness to exercise rehabilitation.      Design: This study is a randomized cross-over controlled intervention to take place at a     University Balance Disorders Laboratory. The study participants will be people with     Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6     weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a     cognitively challenging program based on the Agility Boot Camp for people with PD. The     education program is a 6-week program to teach people how to better live with a chronic     disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are     measures of mobility, cognition and neural imaging.      Discussion: The results from this study will further our understanding of the relationship     between cognition and mobility with a focus on brain circuitry as it relates to     rehabilitation potential.   "
88293|NCT02130362|"     This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in     pediatric patients with moderately to severely active CD who are treated as recommended in     the local product label.   "
80592|NCT02229981|"     This is a sequential Phase I and IIa study to identify the maximum tolerated dose and to     evaluate safety, tolerability, toxicity, pharmacokinetics and pharmacodynamics of the oral     sphingosine kinase inhibitor ABC294640 specifically in patients with diffuse large B-cell     lymphoma (DLBCL), including virus-associated (e.g., KSHV- or EBV-associated) DLBCL or Kaposi     Sarcoma (KS) after failure of or intolerance to initial standard therapy.   "
80593|NCT02229968|"     The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective     in reducing blood loss in children undergoing craniofacial reconstruction surgery.      The investigators hypothesize that Amicar will decrease intraoperative blood loss and     decrease the need for perioperative blood product administration in children undergoing     craniofacial surgery.   "
80594|NCT02229955|"     The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic     solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12     weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety     in Moderate to Severe Dry Eye Disease.      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),     Non-anesthetic Schirmer test   "
80595|NCT02229942|"     The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic     Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from     B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and     maintenance treatment.   "
80596|NCT02229929|"     The primary purpose of this study is to:        -  Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week          in patients who are undergoing hemodialysis. (Part A)        -  This study is also investigating whether repeated doses of IV CR845 over two weeks is          safe and effective in reducing the intensity of itching in hemodialysis patients with          uremic pruritus (Part B).   "
80597|NCT02229916|"     The majority of testicular cancer patients can be cured with cisplatin-based chemotherapy.     Mortality has been reduced even more within the last 15 years due to the stringent     application of standard chemotherapy followed by resection of residual disease. This is a     positive development considering that testicular cancer usually affects young men. Active     surveillance has become an acceptable and widely used strategy in stage I testicular cancer.     Thus, it is important to follow these patients in a standardized way and to adhere to a     rationale surveillance strategy. There is no international consensus regarding follow-up of     testicular cancer patients. Stratification according to risks and patterns of relapse would     allow to tailor follow-up schedules, aiming at early identification of relapse without     causing unnecessary harm by using excessive radiation in these young long-term survivors.     Follow-up procedures should not only aim at detecting relapse, but also long-term side     effects from therapy, including hypogonadism, metabolic syndrome, cardiovascular disease and     secondary malignancies. The Swiss Austrian German Testicular Cancer Cohort Study (SAG TCCS)     will comprise consecutive newly diagnosed testicular cancer patients and is the first study     to prospectively evaluate the initial indictor of relapse in testicular cancer patients, the     frequency and pattern of relapse and document long-term toxicities of the treatment     (cardiovascular, gonadal, hearing impairment, renal function and second malignancies) and     psychosocial aspects. This cohort study will determine the relevance of each test performed     routinely during follow-up. The collected data will have direct implications for the care of     patients with testicular cancer and inform future adaptations of follow-up recommendations.     The dataset will give information on baseline factors of testicular cancer patients patients,     current treatment strategies in Switzerland, Austria and Germany, outcome and late sequelae.   "
80598|NCT02229903|"     The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS)     treatment in subjects with OCD. The device technology is based on the application of deep     brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway     DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS     treatment to sham treatment.   "
80599|NCT02229890|"     Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen     Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute     ischemic stroke   "
80600|NCT02229877|"     The purpose of this study is to: determine the effect of stomach pH on the multiple dose     pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of     gefapixant on various sensory assessments; and, assess the safety and tolerability of     gefapixant.   "
80601|NCT02229864|"     The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling     approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB     III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus     delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only     receive Absorb BVS with a maximum of two de novo native coronary artery lesions after     implantation of the Absorb BVS.      Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III     RCT primary endpoint.   "
80602|NCT02229851|"     This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly     dosing of NNC0195-0092 compared to placebo and once-daily dosing of somatropin (human growth     hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.   "
80603|NCT02229838|"     Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464     p.o once daily in a rising dose group-comparison (placebo controlled, double blind,     randomized per dose level).      Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual     comparison), preliminary assessment of food effects (interindividual comparison)      Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and     Subsequent Randomised, Open Parallel Group Phase).      MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative     Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial     Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent     Randomised, Open Parallel Group Phase).   "
80604|NCT02229825|"     Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized     for severe depression after 4 weeks of treatment. To evaluate the rescue option in     non-responding patients. Safety of Duloxetine will also be assessed.   "
80605|NCT02229812|"     Study to evaluate the safety and efficacy of intravenous alteplase within 3 hours of symptom     onset in acute ischemic stroke patients   "
80606|NCT02229799|"     The objectives of this study are to review the safety and efficacy of Actilyse Vial     (hereafter referred to as Actilyse) in post-marketing use for treatment of acute ischemic     stroke, through investigating followings;        1. Unknown adverse events (especially serious adverse events)        2. Frequency (Incidence) and trend of adverse events under the actual practice        3. Factors on the safety profile of Actilyse        4. Factors on the efficacy profile of Actilyse   "
80612|NCT02230969|"     The primary objectives of the study are to determine the incidence of serious adverse events     (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical     practice and to assess the overall long-term clinical effectiveness of Plegridy in     participants with relapsing forms of MS in routine clinical practice. The secondary     objectives of this study in this study population are to describe Plegridy prescription and     utilization adherence patterns in routine clinical practice; to assess the specific long-term     clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine     clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical     practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS),     injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to     treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness     of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS);     to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare     resource consumption, and treatment adherence over time.   "
80613|NCT02230956|"     This study will evaluate the efficacy and safety of a single intra-articular injection of 2     doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee     osteoarthritis symptoms.   "
80614|NCT02230943|"     The RISE Registry is an enhanced version of the ACR's Rheumatology Clinical Registry (RCR)     and allows for a simplified entry process, while establishing a best-in-class resource to     manage your patient population and improve patient care.      RISE provides participants with an infrastructure for robust quality improvement activities     leading to improved patient outcomes, patient population management and quality reporting     related to rheumatic diseases and drug safety. RISE gives physicians and researchers the     information they need to optimize patient outcomes, meet reporting requirements, and make     discoveries that advance rheumatology.   "
83166|NCT02197416|"     This open-label, single arm prospective cohort study will assess the safety of dabigatran     etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children     from 0 to less than 18 years of age will be eligible to participate.   "
80615|NCT02230930|"     Skin reactions as a result of continuous subcutaneous apomorphine infusion occur frequently     and interfere with the absorption of apomorphine. The histopathology of apomorphine-induced     skin reactions is poorly understood. Therefore treatment options are limited and suggestive.      Objective: to investigate the efficacy of four treatments including massage, dilution of     apomorphine, treatment with topical hydrocortisone and pre-treatment with subcutaneous     administered hydrocortisone, in Parkinson's disease patients with apomorphine-induced skin     reactions.   "
80616|NCT02230917|"     Lytic bone disease continues to be one of the most devastating complications of multiple     myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions     persist and can continue to significantly impact a patient's morbidity, even when an     individual's myeloma is otherwise under good control. To date, no agent has been shown to     have a prolonged bone anabolic response in myeloma.      Preliminary studies treating healthy postmenopausal women with a single dose of sotatercept     demonstrated a rapid and sustained increase in serum biochemical markers of bone formation     and a decrease in markers of bone resorption. Similarly, the murine analog to sotatercept,     RAP-011, increases bone mineral density and strength in murine studies of both normal animals     and models of bone loss. We hypothesize that sotatercept will provide an anabolic response     for bone in myeloma patients with bone disease.   "
80617|NCT02230904|"     The primary objective of the study is to compare the adhesiveness of 2 different patch     formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that     both patch formulations show similar adhesiveness properties.   "
80618|NCT02230891|"     Despite advances in cardiovascular care, the occurrence of heart failure (HF) is steadily     increasing. The increase in HF rates poses enormous challenges, as once an individual becomes     symptomatic or requires hospitalization with HF, the prognosis remains poor. Therefore,     prevention of HF is essential. HF prevention is a critical issue as HF risk factors that     include common medical conditions such as hypertension and diabetes are also increasing.     However, not everyone with these risk factors develops HF. Using novel blood tests, the     investigators propose to identify and treat subjects at higher HF risk to see if the     investigators can stabilize or improve ultrasound measures known to be associated with HF     risk. This study will enroll only Veterans.   "
80619|NCT02230878|"     The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the     study of the way a drug enters and leaves the blood and tissues over time),     dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how     drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female     participants.   "
80620|NCT02230865|"     Pain is an expected part of surgical recovery but effective pain management remains     challenging. The high variability in postoperative pain experience and analgesic treatment     response between patients is part of the challenge. Few studies have yet combined     preoperative assessment of responses to experimental pain with measurements of cognitive and     emotional processes in the prediction of postoperative pain.      We hypothesize, that preoperative evoked brain potentials (using standard     electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain     modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related     catastrophic thinking are useful clinical predictors of postoperative pain and analgesic     consumption.   "
80621|NCT02230852|"     The PreSSUB trial I will focus on prehospital telemedicine for patients with suspicion of     acute stroke. The study is designed as a prospective monocentric observational trial on the     safety, feasibility and reliability of in-ambulance telemedicine for patients with suspicion     of acute stroke during transportation by the Paramedic Intervention Team of the Universitair     Ziekenhuis Brussel.   "
80622|NCT02230839|"     The purpose of this study is to provide information regarding potential factors underlying     metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.   "
80623|NCT02230826|"     This long-term outcomes study is designed to collect safety and efficacy data on designated,     commercially available, Tornier hip arthroplasty products.   "
88891|NCT02122536|"     The aim of this prospective, randomized, double-blind, intraindividual split face study will     be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles     using a 1:1 dose ratio.   "
80624|NCT02230813|"     The term cellulitis is a medical term describing a bacterial infection of the skin and     tissues beneath the skin. Although it is usually easily treated with antibiotics given either     orally or through a vein (intravenously), knowing which route of antibiotic treatment to     prescribe to a person attending an Emergency Department with cellulitis is not clear.      A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research     as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which     patients require oral and which patients require intravenous antibiotics for cellulitis from     their first visit to an emergency department. The aim of this is to provide safer care by     reducing the risk of a patient returning to the hospital with a worsening infection. It will     also promote more cost-effective care by reducing hospital re-attendance rates and wasted     antibiotics.      Patients attending the department with cellulitis who are suitable for oral antibiotic     treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of     study participants in order to reduce bias. A set of physical signs and symptoms will be     recorded from each patient in order to determine which ones are associated with them     failing prescribed oral treatment. A study investigator will then phone the patient after     14 days to see whether they are better or whether they required intravenous antibiotics to     get better.   "
80648|NCT02230501|"     Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT     01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin     demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE     insulin/day. The aim of the present study was to investigate in a randomized-controlled trial     if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or     insulin.   "
80649|NCT02230488|"     The purpose of this study is to assess whether intensive case management interventions by a     diabetes team, led by an endocrinologist and certified diabetes educator, can prevent <31 day     readmission in previously identified high risk patients with diabetes.The procedures of the     study will focus on managing the patient's diabetes and diabetes education while in the     hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital,     and assist in the patient's diabetes management plan for a safe discharge.   "
80625|NCT02230800|"     Side effects are common after treatment with radiotherapy for tumours in the pelvis and can     affect the way the bowel and urinary system work as well as causing sexual difficulties, skin     damage and bone problems. Problems in the bowel, bladder, sexual organs and skin mostly     result from thickening of the tissues in response to radiotherapy, a process called     fibrosis. Fibrosis often worsens over time.      There has been progress in treating bowel symptoms which usually are the worst problem after     radiotherapy. However, even after receiving the best possible treatments, while many patients     are better, they are often not cured of all their difficult problems.      For some years, it has been hypothesised that if fibrosis could be treated then symptoms     would improve. Recent research in laboratory animals has suggested that an effective     treatment for radiation-induced fibrosis is combination therapy with a drug called     Pentoxifylline together with a nutritional supplement containing gamma-tocotrienol (Tocovid     SupraBio), a substance derived from palm oil. Both of these agents are simple to take and     side effects are rare.      This study will recruit volunteers who continue to have difficult side effects after previous     radiotherapy to the pelvis despite receiving the best treatments available from a unique     clinic at The Royal Marsden which has pioneered treatment for bowel problems after     radiotherapy. Two out of every three volunteers who take part, will be randomly assigned to     treatment with Pentoxifylline and Tocovid SupraBio, while one out of three will receive dummy     pills. Neither the patients nor the staff assessing them will know which treatment they have     been given. Volunteers take the active treatments or dummy tablets for a year and will be     assessed regularly while on treatment and for a year afterwards. This study will show whether     active treatment is more effective than dummy pills in improving the symptoms caused by     radiation-induced fibrosis.   "
80626|NCT02230787|"     Enamel matrix proteins have been shown to play a crucial role during tooth development and     its supporting tissues. This is used in periodontal surgery where regeneration of lost     tissues around the teeth is intended. Emdogain, a product of Straumann Institute contains     these matrix proteins and has been successfully used in regenerative periodontal surgery for     more than 16 years.      The treatment of gum recession is a common requirement, more and more patients are seeking     treatment at the investigators' clinic due to aesthetic concern, root sensitivity and     difficulties in performing adequate oral hygiene. The standard treatment comprises the     transplantation of a piece of connective tissue from the palate to the denuded root surface.     In many cases Emdogain is additionally applied to enhance healing. So far the effect of     Emdogain on the early wound healing process after surgical root coverage has not been     investigated.      The purpose of the investigators' study is to compare early wound healing parameters between     treatment with and without Emdogain. For this study 40 patients undergoing root coverage     surgery at the investigators' department will be included. Early wound healing features     between the two groups will be described and compared. Furthermore, inflammatory markers     typical for early healing will be evaluated together with patients`subjective postoperative     comfort. Finally, outcomes 6 months after the treatment will be assessed. The investigators'     hypothesis is that Emdogain treatment enhances wound healing and decreases post-operative     complication rates.   "
80627|NCT02230774|"     The main purpose of this study is to assess and compare the hydration status of medical and     nursing staff and to investigate the relationship between the hydration status, cognitive     function and serum cortisol (marker of stress).      We hypothesise that a significant proportion of doctors and nurses will be dehydrated at the     end of their working day. Some, as in other occupations, may be dehydrated at the start of     their working day. This is likely to be associated with impairment in cognitive performance     at the end of the working day compared to the beginning and expected to be more pronounced     after a night shift. There may be less noticeable difference amongst nursing staff given the     protected break time. Dehydration and associated impairment in cognition is of important     clinical value as it can impact patient care. participants will be involved in the study for     two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as 15     medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15 day     and 15 night shifts from each group). Those that do not work both day and night shifts will     participate for only one shift and a new participant will be recruited until target number of     shifts is achieved.   "
80628|NCT02230761|"     This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids     for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe     steatoblepharon (excess eyelid fat).   "
80659|NCT02230358|"     The aim of this study is to investigate the differences between the cardiac output and the     cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a     randomized, controlled, single center study at the Medical University Innsbruck, Department     of Anesthesia and Intensive Care Medicine.   "
80629|NCT02230748|"     -  Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice        -  Indication: For which reasons is the indication for implantation of LAA-Occluder put for          patients with atrial fibrillation?        -  Safety: How save is the implantation of LAA-Occluders?        -  Effectiveness: How effective is implantation of LAA-Occluders in daily clinical          practice?        -  Concomitant treatment: Which concomitant treatment is prescribed for patients with          LAA-Occluder?   "
80630|NCT02230735|"     Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral     ligaments experience less pain postoperatively, need less narcotic pain medication and return     to activities of daily living sooner.   "
80631|NCT02230722|"     The investigators propose to develop a novel intervention that targets the system     (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran     (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain     management alternatives.   "
80632|NCT02230709|"     The aim of this study is to determinate the effects of percutaneous electrical nerve     stimulation in the short-term for pain in patients with myofascial chronic neck pain.   "
80633|NCT02230696|"     To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA     approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.   "
80634|NCT02230683|"     This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of     IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.   "
80635|NCT02230670|"     This is a multicenter study to see if treatment with IDN-6556 can help improve the liver     function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores     between 11-18.   "
80636|NCT02230657|"     The purpose of this study is to identify differences in satisfaction, pain and length of stay     between patients undergoing hip replacement who are discharged from the hospital on the day     of surgery compared to patients who stay one night in the hospital.   "
80690|NCT02229734|"     This study will explore the combination of a stereotactic body radiation therapy (SBRT)     approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for     older men with high risk prostate cancer, or men unwilling to undertake conventionally     fractionated therapy and three years of adjuvant hormone therapy.      The purpose of this study is to examine the safety of a shorter course of radiation treatment     combined wtih androgen deprivation therapy.   "
80637|NCT02230644|"     Over 4.6 million operations are undertaken each year in England alone. Of these, many     patients experience psychological distress, which has negative implications for patient     recovery. Indeed, psychological stress, in particular both trait and state anxiety, anger and     distress, has been linked with slower wound healing (Broadbent et al., 2003) and more     complicated post-operative recovery (Johnston and Wallace, 1990).      However, pre-operative psychological interventions can have significant positive effects on     components of of post-operative recovery (Navros et al., 2011; Weinman and Johnston, 1988).     In particular, music has been studied in a series of randomised control trials as a way of     reducing pre-surgical stress. Studies have shown the effects of music in reducing levels of     stress hormones such as cortisol (Leardi et al., 2007) and reducing both heart rate and blood     pressure, and have also found music to be more effective than benzodiazepine at reducing     pre-surgical anxiety (Bringman et al., 2009).      Chelsea and Westminster Hospital NHS Foundation Trust is a major surgical hospital,     performing over 15,000 adult operations annually. Consequently, strategies to reduce patient     anxiety and improve experience are amongst the hospital's priorities. A renovation of the     Surgical Admissions Lounge is currently underway with plans to incorporate visual arts and     music in waiting booths to relax and distract patients. When asked how relaxing they found     the space, patients at Chelsea and Westminster Hospital involved in a public consultation     rated the current unenhanced waiting area as 5.8/10, but 93% of patients said that relaxing     music would help them feel less anxious. This project will test whether music and art in the     SAL actively reduce adult patient stress compared to normal unenhanced waiting spaces, with a     view to extending the arts interventions to other surgical waiting areas such as the day     treatment centre if there are significant positive findings.   "
80638|NCT02230631|"     This survey is conducted in South America. The aim of this survey is to investigate     hypoglycaemia among Insulin-treated patients with diabetes.   "
80639|NCT02230618|"     This study is conducted in Asia. The aim of this study is to evaluate long term safety and     efficacy in patients with diabetes mellitus in routine clinical practice in India.   "
80640|NCT02230605|"     Many individuals experience an acute change in thinking and reasoning skills after surgery.     This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after     surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study     is to determine if performing mental exercise, before surgery, will help reduce post-surgery     memory and thinking problems. A total of 268 patients will be recruited for this study.      At least 10 days before surgery, subjects complete a series of questionnaires to assess     baseline cognition level (or thinking ability) and status of overall well-being. At the     completion of the screening visit, qualifying subjects are randomized into two groups:      Participants randomized into the Cognitive Exercise group are expected to complete     tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for     the duration of the preoperative period. Participants in this group are expected to achieve 1     hour of mental training each day for at least 10 consecutive days prior to surgery.      Participants randomized into the Normal Activity group are encouraged to carry out their     baseline daily activities, and do not have any study-related cognitive exercise expectations     before surgery. These subjects still complete the same questionnaires and assessments as the     Cognitive Exercise group throughout the study, however, are asked not to alter their normal     daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are     not permitted to subscribe to Lumosity while in the research study.      On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is     taken before surgery. During surgery, research personnel monitor vital signs and medications     given. After surgery, another CAM evaluation is taken in the post-operative recovery room.      Throughout the subject's hospital stay, pain levels and medication usage are recorded. The     CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity     of PD. The evaluations are given twice daily, at approximately 6:00 AM and 6:00 PM, for 7     days or until hospital discharge (whichever comes first). The Postoperative Quality of     Recovery Scale (PQRS) is used each post-operative day at 6:00 PM until discharge, and     completed over the phone on POD 7 if patient discharged. The PQRS is also administered over     the phone on POD 30 and POD 90.   "
80657|NCT02230384|"     The investigators will evaluate effects of a novel drug that improves nicotinergic receptor     function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have     a high interest in quitting. The investigators predict that the novel drug will increase days     of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking     cessation in smokers with schizophrenia.      The investigators will also assess if this new drug decreases nicotine withdrawal, craving,     and cognitive impairment during early abstinence, as well as evaluate adverse effects.   "
80658|NCT02230371|"     The aim of this study is to to investigate if local treatment with intramuscular injections     of granisetron are effective in alleviating pain in patients with chronic myofascial pain in     the orofacial muscles      The study hypothesis is that local administration of granisetron reduces pain and     allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and     that this effect of granisetron on pain is larger than the effect from placebo   "
80641|NCT02230592|"     Objective:      Metabotropic glutamate receptors (mGluRs) are G-protein coupled receptors that respond to     glutamate by activating proteins inside nerve cells that affect cell metabolism, thereby     fine-tuning the signals sent between cells to maintain balance in neuronal activity. mGluR     subtype 1 (mGluR1s) are located in several brain regions, including the cerebellum,     hippocampus, olfactory bulb, and basal ganglia. mGluR1 activation stimulates phospholipase C,     resulting in phosphoinositide hydrolysis and increased intracellular calcium levels.     Successful development of a positron emission tomography (PET) ligand to image mGlurR1 would     impact clinical management of brain disorders characterized by disruptions in glutamatergic     transmission, including anxiety and stress disorders, drug addiction, epilepsy, Huntington s     disease, and Parkinson s disease. However, detailed study of mGluR1s has heretofore been     hindered by the lack of high affinity and selective ligands for this receptor subtype.      The present protocol will evaluate the ability of a new PET ligand, [18F]FIMX, to image and     quantify mGluR1 in the brain of healthy human volunteers. This protocol covers four phases:        1. Phase 0: screening whole-body scan;        2. Phase 1: kinetic brain imaging to quantify mGluR1 in brain relative to concurrent          measurement of the parent radioligand in arterial plasma;        3. Phase 2: if the tracer is successful in Phase 1, we will estimate radiation-absorbed          doses of [18F]FIMX by performing whole body imaging;        4. Phase 3: test-retest analysis of brain binding relative to concurrent measurement of the          parent radioligand in arterial plasma.      Study Population:      Healthy adult female and male volunteers (n=22, ages 18 to 55) will undergo brain or     whole-body imaging..      Design:      This study will begin with a screening whole-body scan to confirm that the radioactivity has     fairly broad distribution in several organs. For absolute quantification of mGluR1, 22     healthy controls will have brain PET imaging using [18F]FIMX and an arterial line. Up to 12     of them will have a test-retest scan. Eight additional subjects will have a whole body PET     scan for dosimetry, which does not require an arterial line.      <TAB>      Outcome Measures      To assess absolute quantitation of mGluR1 with [18F]FIMX, we will primarily use two outcome     measures: the identifiability and time stability of distribution volume calculated with     compartmental modeling. In test-retest study, we will calculate the retest variability. To     assess whole-body biodistribution and dosimetry of [18F]FIMX we will use the organ     time-activity curves.   "
80642|NCT02230579|"     This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability     and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when     administered to healthy male volunteers and female volunteers of non-childbearing potential.      In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be     investigated.   "
80643|NCT02230566|"     The Phase 3 study will use a novel randomized, intra-subject placebo-controlled, single     crossover design, referred to as Blind Start, to evaluate the safety and efficacy of UX003.   "
80644|NCT02230553|"     This is an open-label phase I/II multi-center study consisting of two parts. Part A of this     study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with     trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell     lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the     lapatinib-trametinib combination versus standard of care therapy in patients with metastatic     KRASm/PIK3CAwt NSCLC.   "
80645|NCT02230540|"     The aim of this investigation is to study how the position of different catheters affect     drainage of the bladder.   "
80646|NCT02230527|"     This is a single center, prospective, randomized, unblinded, open-label, active controlled     pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel     plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a     percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.   "
80647|NCT02230514|"     The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures     (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac     crest.      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by ex-vivo expanded autologous     mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and     Tissue Bank of Catalonia).      The working hypothesis proposes that the tissue engineering is a valid and useful technique     to achieve bone regeneration up to consolidation of non-union fractures.   "
80650|NCT02230475|"     This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic     rhinitis symptoms in participants under controlled conditions, to collect well-characterized     biological samples (urine and blood) before and after they develop these symptoms. The EEU     provides the ability to control the timing, duration and levels of allergen exposure, and     also other outside environmental factors, yielding ideal biologic samples for analysis with     novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic     rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance     analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on     blood samples and compared to spin prick testing and symptoms of allergic rhinitis.   "
80651|NCT02230462|"     The purpose of this study is to assess the effects of visualization of skin cancer resection     defects on the face on the post-operative satisfaction of patients after their     reconstruction. To achieve this aim, patients invited to participate in this study will be     randomized to either seeing or not seeing their skin cancer excision defect prior to     reconstruction. After reconstruction, patient satisfaction will be assessed in both groups to     determine if visualization of the defect prior to reconstruction has any effect on patient     satisfaction and if any detected effect has durability over time.   "
80652|NCT02230449|"     The aim of the study is to analyze the expression of genes and microRNAs potentially involved     in oocyte competence in follicles of different sizes (<17mm and ≥17mm) at the time of oocyte     pick-up.   "
80653|NCT02230436|"     The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce     the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy     compared with later removal of drain.   "
80654|NCT02230423|"     This study investigates wether patients with increased trigeminal perception threshold and     low expression of TRP channels have more often nasal blockage despite functionally successful     nasal surgery (TRP channel = transient receptor potential channel).   "
80655|NCT02230410|"     To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro     ablation .   "
80656|NCT02230397|"     Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the     revitalizing activity of a face cream applied twice a day, morning and evening, for an     uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face     ritidosis and women aged 55-65 years not habitual user of antiage-creams.      The study foresaw the comparison within subjects of the study product versus placebo (half     face method).      It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the     volunteers and tolerance both by investigator and volunteers.   "
80698|NCT02229630|"     The purpose of this study is to compare the apparent diffusion coefficient in the frontal     lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared     with foetuses with intra-uterine growth restriction and a good neonatal outcome.   "
80660|NCT02230345|"     The important role played by the GI tract microflora on the metabolic health of an individual     are increasingly recognized. In this respect, the initial studies of Metchinkoff that     suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora     have evolved into the concept of probiotics. Probiotics are living microorganisms that     bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).      Here the investigators will study, in normal young male volunteers, the potential to modulate     post-prandial metabolic and inflammatory responses by the administration of a yoghourt     containing the probiotic Lactobacillus rhamnosus (LGG).   "
80661|NCT02230332|"     Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against     stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA)     and inhaled corticosteroids (ICS) has become the most commonly used asthma controller     medication class in the United States, but unfortunately, even when LABAs are added to ICS     and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use     of beta-agonists, both short and long-acting, reduces the ability of these agents to protect     against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli.     We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial     we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor     internalization, can reduce the loss of bronchoprotection that occurs with regular use of     LABAs, even when used in combination with ICS.   "
80662|NCT02230319|"     The purpose of this study is to determine if cryotherapy can effectively decrease the rate of     neuropathy in patients undergoing weekly paclitaxel treatments.   "
80663|NCT02230306|"     The purpose of this study is to evaluate the effectiveness of the combination of vemurafenib     with cobimetinib in patients with active melanoma brain metastases.   "
80664|NCT02230293|"     The purpose of this study is to determine if multidisciplinary care improves the health     condition of hypertensives.   "
80691|NCT02229721|"     The purpose of this study is to determine whether intranasal oxytocin is effective in     comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal     women.   "
81920|NCT02213705|"     The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic     mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment     will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide.   "
80665|NCT02230280|"     Most stroke survivors live with other chronic health conditions that can negatively affect     their recovery and overall health and well-being. Although stroke care has improved, there     are still many challenges to the delivery of community-based stroke care. These challenges     include: poor coordination of care across health care providers and settings; limited     communication among health care providers; limited use of evidence-based treatment     guidelines; difficulties navigating community services and supports; and limited client and     family caregiver involvement in making healthcare decisions. The investigators developed a     new mobile health (mHealth) application, My Stroke Team (MYST), to address these challenges     to improve the overall quality of stroke care at home. This study will expand this work to:     1) explore the feasibility and acceptability of this mobile tool, 2) determine its impact and     usability for home care providers, stroke survivors, and their family caregivers, and 3)     determine its impact on the costs of use of health services.   "
80666|NCT02230267|"     Several animal and human epidemiologic studies have provided evidence that exercise may be     neuroprotective in Parkinson's disease (PD). Exercise may forestall diagnosis and, in the     case of those who have already been diagnosed with PD, it may slow the observed     neurodegeneration. Unfortunately, because this line of research is in early stages, there is     little evidence to indicate what biological mechanisms underlie the neuroprotection that is     conferred with exercise. Toward this end, it is possible that an interaction between     endogenous antioxidant enzymes, inflammatory processes, and reactive oxygen species may be     associated with exercise improvements in PD.      One of the most common reasons for premature death in PD is falls. Several meta-analyses have     concluded that exercise training programs focused on balance and/or strength training are     effective at improving aspects of balance. Taken together, the current body of evidence     suggests that exercise may be neuroprotective and balance/strength training may decrease the     likelihood of a fall. The combination of these efficacious treatment modalities (exercise and     balance/strength training) in a comprehensive treatment approach to improve PD symptoms and     balance has been previously reported at relatively mild or moderate exercise intensities.     Because recent research has suggested that patients with PD may benefit more from more     physically intense programs, we are proposing a more aggressive approach with regard to     exercise intensity and frequency in the present trial. The primary purpose of this study is     to determine the feasibility and safety of a high intensity exercise approach to PD. A     secondary purpose is to determine the trajectory of change in outcomes over the duration of     the trial from a high intensity fall prevention program. It is hoped that a signal of     efficacy will allow this trial to progress to a comparative effectiveness trial. An important     innovative design element is collecting biological assays to better understand the mechanism     underlying the anticipated clinical improvements.      Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp     (HIBC) in patients with PD by analyzing adherence and whether they achieve minimum Centers     for Disease Control exercise standards (150 min/wk moderate level aerobic exercise;     strengthening at least two times per week) for the duration of the trial. Aim 2 is to     determine if participation in an 8-week HIBC under the direction of a physical therapist is     safe for individuals with PD. Secondary Aim 3 is to determine if participation in an 8-week     HIBC will produce a signal of efficacy for several physical outcomes: falls per physical     activity ratio, balance efficacy, motor activity, fatigue, muscle strength, bone health,     cognition/mood, and quality of life. Secondary Aim 4 is to determine if participation in an     8-week HIBC will produce a signal of efficacy for biological outcomes, anti-inflammatory     cytokines and anti-oxidant enzymes. An additional exploratory aim will be an analysis of BDNF     val66val, val66met, met66met polymorphisms to determine if there is a differential response     to exercise.      This trial is innovative because it utilizes a high intensity comprehensive exercise     treatment approach (aerobic exercise, strengthening, and balance training). To our knowledge,     there have been no trials of individuals with PD who have participated in a trial of this     intensity in a group boot camp setting. Another innovative design element is the use of     three novel assessments: biological assays of pro- and anti-inflammatory cytokines,     endogenous anti-oxidant enzymes and a novel assessment of falls (falls per physical activity     ratio).      Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual     care control group (standard, low intensity group therapy class) under the direction of     physical therapists. Each group will have 15 participants with a 1:5 patient-to-therapist     ratio. The HIBC will be 1.5 hours daily, Monday through Friday. Participants will be required     to attend 3 out of the 5 days. The protocol of the HIBC will include the following exercise     components: A. 30 minutes of moderate-high intensity aerobic exercise; B. 15 minutes of     strengthening the major muscle groups; C. 15 minutes of balance training; and, D. 15 minutes     of interspersed rest and stretching. Participants will rotate through these four exercise     components. Participants will have one baseline test and assessments at the 2-week, 4 week,     8-week, and 6-month points. Outcomes of the primary aims (Aim 1 and Aim 2) will be frequency     counts of participation, adverse events, and compliance with exercise. The outcomes for the     secondary aims will include measures of balance and falls, physical capacity, fatigue,     exercise/physical activity behavior, and biological assays.   "
80667|NCT02230254|"     PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM     Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of     Atherosclerotic Lesion(s)   "
80668|NCT02230241|"     This is a multi-center survey of patients who are currently receiving lipid-lowering     medications and have a moderate or higher cardiovascular (CV) risk. The survey will be     conducted in the Russian Federation. Data collection for each study subject will be done     within one physician visit. If an enrolled subject comes to the visit not fasting (for at     least 8 hours), an appointment for the blood tests will be made for another day.   "
80669|NCT02230228|"     This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of     ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.   "
80670|NCT02230215|"     This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging     to determine whether patient-specific instrumentation for total knee arthroplasty     (replacement) has an effect on implant loosening compared to conventional instrumentation.     Secondary objectives will include assessment of post-operative implant alignment, patient     satisfaction, operative time and surgical instrument use, cost, and environmental impact.   "
80671|NCT02230202|"     The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment     with calcineurin inhibitors (CNIs) are each associated with the release of endothelial     microparticles into the plasma.   "
80672|NCT02230189|"     This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs)     that are differentially expressed in the airway epithelium of patients with asthma at     baseline and in response to allergen challenge. We hypothesize that allergen exposure     enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a     consequence of locally increased T-cell derived cytokine production. The study will involve     three visits over the course of approximately 14 days. At Visit 1, participants will be     characterized in detail with lung function testing, methacholine challenge testing, and     allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with     segmental allergen administration of either cat or dust mite standardized allergen extract.     At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect     airway samples including bronchoalveolar lavage (BAL), epithelial brushings and endobronchial     biopsies. Sample analysis will include measurement of miRNA and mRNA expression in epithelial     brushings (RNAseq and qPCR); analysis of cell surface markers on BAL cells and blood cells;     and collection of endobronchial biopsies for immunostaining of immune cells localization,     immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth     muscle cell subculture. A total of 38 subjects (26 asthmatics with stable or well-controlled     asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.   "
80673|NCT02230176|"     This study is the first randomized, open-label, national, multicenter, phase II study     assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic,     inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine     tumors (WDpNET). Subjects must have experienced documented progression of disease within 1     year prior to the start of the study. The control group of patients receiving Sutent will be     used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients     receiving Sutent.   "
80674|NCT02230163|"     Chikungunya virus (CHIKV) has been detected in humans in the Caribbean area for the first     time in November 2013 (St-Martin Island). By February 2014, the virus had spread to several     other Caribbean islands as well as French Guyana, South America. During the outbreak of     Chikungunya that affected the Reunion island in 2005/2006, it was observed that the neonatal     forms of infections acquired by mother to child transmission during childbirth, were not the     exception and were critical. Mother-to-child transmission occurs when the mother is viremic     at the time of delivery. The mean duration of viremia after the onset of first clinical     symptoms is six days. The rate of mother-to-child transmission is 50%. All neonates     contaminated during labor and delivery present with a symptomatic disease and the rate of     severe forms is about 50%, primarily due to damage of the central nervous system, often     leaving permanent damage (seizures, cerebral palsy).Due to the severity of Chikungunya in     neonates and the burden of cerebral palsy, it is imperative to identify a safe and effective     preventive and/or curative intervention. Human polyvalent immunoglobulins purified from     plasma samples obtained from Chikungunya-convalescent donors exhibit a potent neutralizing     activity in vitro. They were evaluated for their preventive and curative effects in a     neonatal mouse model of CHIKV infection. After administration of a lethal dose of CHIKV, all     neonatal mice that had received immunoglobulins survived while all control animals that had     received non hyperimmune immunoglobulins died. In humans, specific human immunoglobulins     proved to be effective and safe in neonates born to hepatitis B viremic mothers.      Hypothesis : The investigators hypothesize that the administration of anti-CHIKV hyperimmune     human intravenous immunoglobulins to neonates exposed to a high risk of severe form of     Chikungunya infection is safe enough to justify its evaluation in an open non randomized     trial aimed to confirm the safety and preliminary assess the efficacy of this intervention.   "
80675|NCT02230150|"     The purpose of this study is to verify the impact of the educational intervention in the     adhesion to therapeutic strategies for patients with heart failure.   "
80676|NCT02230137|"     The purpose of this study is to assess HbA1c reduction after supportive care by SMS among     adolescents with poorly controlled type 1 diabetes.   "
80677|NCT02230124|"     The purpose of this project is to assess the utility of a new magnetic resonance technique     called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure     hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for     hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but     atrophied brain, a distinction not possible with conventional MR imaging studies that are     presently available.   "
80678|NCT02230111|"     The purpose of this study is to measure the effects of a reduced-calorie low energy density     diet with and without increased cognitive dietary restraint (CDR) on stress (biological     markers and perceived stress), eating behaviours, appetite sensations, anthropometric     variables and women's attitude toward their children's eating behaviours in premenopausal     overweight/obese women in both the short term (immediately after the end of the 4-week     intervention) and longer term (3 months after the end of the intervention). The investigators     hypothesize that cortisol concentrations are higher, appetite sensations are increased (i.e.     increased global appetite score) and food cravings are more prevalent in women of the     energy-restriction-plus-CDR group than in women of the energy-restriction-without-CDR group     after the 4-week intervention. They also hypothesize that perceived stress is higher and food     cravings are more prevalent in women of the energy-restriction-plus-CDR group than in women     of the energy-restriction-without-CDR group at 3-month post intervention. They hypothesize     that no significant difference in body weight changes is observed between the two groups and     that maternal restriction of their child's eating is higher in the     energy-restriction-plus-CDR group than in the energy-restriction-without-CDR group both after     the 4-week intervention and at the 3-month follow-up.   "
80679|NCT02230098|"     Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart     disease accounts for the bulk of it. The purpose of this study is to clarify whether a     mechanical method of remote ischemic conditioning in the form of short-term obstruction of     the blood supply to the arm, can improve the heart's blood supply in patients with ischemic     heart disease. This will be attempted through experiments on patients with ischemic heart     disease and experimental animal studies with simulated cardiovascular disease.      This study will help to clarify whether remote ischemic preconditioning can be used to treat     patients with ischemic heart disease.   "
80680|NCT02230085|"     While continuous positive airway pressure (CPAP) is the gold standard treatment of     obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The     adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire.     The data collected from this trail allows for closer monitoring of at-risk patients. For the     study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA.     Participants will be provided with a GSM (Global System for Mobile communication) modem to     allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30     and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the     GSM unit is returned, and participants continue with CPAP therapy as instructed by their     healthcare provider.   "
80681|NCT02230072|"     The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique     for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.      The investigators hypothesis is that this minimally invasive technique is feasible, and that     this approach will have the same efficacy as open fetal surgery for MMC, but with     significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery.     The fetus will have a repaired MMC defect, and the mother will not have a uterine incision     (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all     subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term     Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open     operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if     the baby is shown to have a skin covered repair.   "
80682|NCT02230059|"     The purpose of this study is to assess the treatment patterns in participants with metastatic     castration-resistant prostate cancer (mCRPC). Additionally, participant's demographic and     clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate     specific antigen (PSA) levels and pain related to disease and overall survival will be     observed.   "
80683|NCT02230046|"     The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic     parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current     commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or     drinking) conditions in healthy male participants.   "
80684|NCT02230033|"     The purpose of this study is to assess the effect of multiple doses of itraconazole or     gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood     and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021) in     healthy male participants.   "
80685|NCT02230020|"     Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand     during sleep. The central hypothesis of this proposal is that lowering ventilatory demand     using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on     exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT     over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.   "
80686|NCT02230007|"     The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of     elderly patients, the therapeutic resources to control the passing pain require in their     manipulation a certain caution and are not divested of side effects badly tolerated at this     age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative     of choice in the care of these pains, in particular in case of pre-existent cognitive     achievement, of polypathologies or of polymédication.      The gas MEOPA administered to the mask could thus be an effective additive in the     physiotherapy treatment of the elderly person.      The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint     articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation     within a population of elderly patients presenting a pain during the physiotherapy treatment.   "
80687|NCT02229773|"     Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene     cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary     pharmacokinetics   "
80688|NCT02229760|"     To determine the effect of steady-state tipranavir 500 mg/ritonavir 200 mg (TPV/r) on     intracellular concentrations of zidovudine triphosphate (ZDV-TP) and carbovir triphosphate     (CBV-TP) and plasma viral load   "
80689|NCT02229747|"     The objective of this study was to assess the clinical efficacy and safety of meloxicam     suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or     nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with     a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis   "
80692|NCT02229708|"     The purpose of this study is to find out whether a technology-base healthy lifestyle program     is an acceptable and effective way for African-American mothers to improve their eating and     activity during pregnancy, compared to usual obstetric care. The goal of the program is to     enhance the health of African-American mothers and their babies.   "
80693|NCT02229695|"     This is a prospective comparison trial. Patients that will be included in the trial are those     that will have operations in which their abdominal closure is temporary, i.e. patients     sustaining trauma or septic abdomen.      Patients will be grouped according to the method of temporarily abdominal closure (TAC)     procedure:        1. Vacuum-assisted closure (VAC)        2. Bogota bag (BB), a sterile intravenous bag silo closure. The two methods are currently          accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center          the decision to choose either of the methods is at the surgeon's discretion.      Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure     technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done     as part of the monitoring processes of critically ill patients in the General Intensive Care     Unit (GICU).      Patients will be evaluated for the development of acute intra abdominal hypertension with or     without abdominal compartment syndrome.   "
80694|NCT02229682|"     This study is to make sure whether reduced-dose radiation treatment is sufficient to control     the disease in patients with early-staged extranodal nasal-type NK/T-cell lymphoma, who have     got complete remission tumor after chemotherapy in a new and more effective     asparaginase-based GELOX regimen   "
80695|NCT02229669|"     This study compared the clinical outcomes of coronally advanced flap using two different     surgical strategies in the treatment of multiple gingival recessions.   "
80696|NCT02229656|"     Accelerated, normofractionated radiotherapy is the treatment of choice in stage II-III     laryngeal and oropharyngeal squamous cell carcinoma (SCC). However, twenty to thirty percent     of patients with stage II-III laryngeal and HPV negative oropharyngeal SCC develop disease     progression, mainly due to lack of locoregional control. Radiosensitizers such as cisplatin     and cetuximab are added to radiotherapy in more advanced stage of head and neck (H&N) cancer.     These radiosensitizers improve loco-regional control and overall survival. Unfortunately, as     these radiosensitizers, notably cisplatin, also dose intensify the radiation dose in normal     tissues, they also significantly increase toxicity. Adding a more tumor-specific     radiosensitizing agent could improve loco-regional control and overall survival without     significantly increasing toxicity.      Radiotherapy kills tumor cells by inducing DNA damage. The efficacy of radiotherapy is     limited by the ability of tumor cells to repair this DNA damage. Poly(ADP-ribose)polymerase     (PARP) is an essential enzyme in base excision repair and single strand break DNA repair, DNA     lesions arising from radiation treatment. PARP inhibition and consequently the inhibition of     PARP-facilitated DNA repair enhances the anti-tumor activity of radiotherapy, as shown in     preclinical studies including head and neck xenograft studies. This radiosensitization is     thought to be proliferation dependent and is more pronounced in homologous recombination (HR)     deficient cells, providing an opportunity for tumor specific targeting. Genetic analyses     suggest that HR deficiency is commonly found in H&N SCC: ATM loss has been reported in 60% of     human H&N SCC biopsies and FANC-F defects were reported in 15-21% of human H&N SCC biopsies     and cell lines.      The efficacy of radiotherapy is also limited by tumor hypoxia, as tumor hypoxia results in     radioresistance. Some PARP inhibiting compounds increase tumor perfusion in xenograft models,     thereby reducing hypoxia and specifically sensitizing tumor cells to radiotherapy. Hypoxia is     commonly found in H&N SCC and a high pre-treatment hypoxic fraction in H&N SCC tumors is     associated with worse outcome. The high prevalence of both hypoxia and HR deficiencies in H&N     SCC support the concept of tumor-specific radiosensitization by PARP inhibition in head and     neck cancer patients.      Olaparib is a potent PARP inhibitor developed as an anti-cancer drug for HR defected tumors     and as a dose intensifier for chemo- and radiotherapy. In humans, olaparib has a low toxicity     profile as a single agent, with increasing bone marrow toxicity when combined with     chemotherapy. The combination of olaparib and radiotherapy for H&N SCC is expected to improve     locoregional control and thereby overall survival. However, this combination treatment has     never been tested in humans before. The purpose of this study is to determine the safety and     tolerability of radiotherapy for stage II-III laryngeal and stage II-III HPV-negative     oropharyngeal SCC with concurrent olaparib.   "
80697|NCT02229643|"     Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an     important role in mediating neuroanatomical plasticity and functional recovery following     traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin     and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h     posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma     Score and prognosis of such patients with traumatic brain injury.   "
80699|NCT02229617|"     For people who identify as transgender, there is a strong sense that they were born into the     wrong body and that their outward looking body does not match how they truly feel about     themselves. They feel male, not female and have always felt that way. There is a great deal     of discomfort or dysphoria about looking and feeling female, and there is a strong desire to     achieve a more masculine appearance. While surgery, clothing and hair for example, can help a     person appear more like a male, many transgender males will want to take testosterone to make     them feel and look more masculine.      This usually involves injecting testosterone into a muscle every 1-2 weeks for many years.     Intramuscular injections can often be uncomfortable or painful, and requires the patient to     be taught how to inject themselves. Or somebody else has to do it. There is a growing trend     in some transgender men to give their injection just below the skin or subcutaneously (like     insulin in a diabetic), because it is less uncomfortable but we don't really know if     testosterone gets into the blood in the same way. At least one clinic in the US already     suggests that patients can use the subcutaneous method but there is almost no research to     show it's the same as intramuscular.      Our project will be looking at a small group of transgender males who are already on     intramuscular testosterone and then switch them over to the same dose of subcutaneous     testosterone, and then compare their levels of testosterone. If those levels are similar,     then patients may chose the less uncomfortable subcutaneous injection.   "
80700|NCT02229604|"     Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes     dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents     and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular     menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH)     and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect     of EA versus other therapies for DOR.   "
80701|NCT02229591|"     Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing     expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation     and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles     dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise     tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is     that EFL should affect post operative outcomes like incidence of pulmonary complication and     length of stay in hospital   "
80702|NCT02229578|"     Burn pain is known to be one the most severe forms of acute pain often requiring large     amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for     controlling pain in various settings including dressing changes of burns. The aim of this     study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and     narcotic requirements when applied to donor graft sites while at the same time not     interfering with the standard of care TheraBond dressing. During this study the investiagtors     will be monitoring for evidence of delayed wound healing, and surgical site infection.   "
80703|NCT02229565|"     The purpose of this study is to further elucidate the molecular mechanisms underlying     prostate cancer disparities. In previous work the investigators have identified a set of     differentially deregulated genes in African American versus Caucasian American prostate     cancer. Based on these findings, they hypothesize that they will be able to validate these     targets, originally identified in the previous work conducted at The George Washington     University Medical Center, in an independent Duke University Medical Center cohort of     prostate cancer specimens. In addition, the investigators hypothesize that they will be able     to discover novel targets in the Duke University Medical Center cohort of prostate cancer     specimens because of regional differences.   "
80704|NCT02229552|"     The study is designed to assess habituation of behavioral responding for food as risk factors     for increases in Standardized Body Mass Index (zBMI) over three years in non-overweight     children.   "
80705|NCT02229539|"     The purpose of this study is to test whether a mouthwash made with a drug called doxepin can     reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth     rinse preparations exist for patients with treatment-related oral mucositis pain such as the     DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin     compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by     the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term     pain management, as well as management of rash.   "
80706|NCT02229526|"     The initial trial examined if fish oil supplementation during pregnancy could reduce the risk     of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in     pregnancies that were at increased risk of these complications. The study was designed as a     multi-centre clinical trial based in 19 hospitals in seven countries in Europe.   "
80707|NCT02229513|"     The objective of the study is to demonstrate whether cooling the uterine smooth muscle during     cesarean section (following delivery of the fetus) will promote better uterine contraction     and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer     hysterectomies following cesarean section. The investigators suspect that it may.   "
80708|NCT02229500|"     Obesity, with its associated co-morbidities, is a major public health challenge. It is     estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is     associated with increased risk of developing diabetes, cardiovascular disease, and certain     cancers. The increasing epidemic of obesity has necessitated the study of the complex     mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are     tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of     cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several     gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been     shown to play an important role in regulating short-term food intake. Peripheral     administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man.     PYY, GLP-1 along with a host of other hormones are produced by the gut in response to     nutrient availability in different regions of the gut and provide an exquisite mechanism of     nutrient sensing in response to dietary intake. These hormones therefore represent potential     targets in the development of novel anti-obesity treatments. A novel and attractive strategy     to induce appetite regulation is the enrichment of foods with components that stimulate the     release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial     fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY     and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free     fatty acid receptors (FFAR) on colonic L cells. Of the SCFAs produced by colonic fermentation     of dietary fibre, propionate has the highest affinity for FFAR 2. Furthermore, propionate is     an end product of bacterial metabolism, and thus, unlike acetate, does not undergo conversion     to other SCFAs. Increasing colonic propionate is therefore an attractive target for appetite     modulation.      We have developed a novel delivery system for delivering propionate to the right site in the     colon and we now wish to optimise the delivery of propionate to the colon in man using stable     isotope labelling methods.   "
80710|NCT02229474|"     This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger     Identification and Intervention for Dementia in Elderly Africans (IDEA) study.      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to     facilitate diagnosis of, and therapy for, people with dementia led by local communities in     sub-Saharan Africa. We aim seek to improve quality of life for people with dementia and their     caregivers.      Within this trial of CST, we hypothesise that CST can significantly improve the quality of     people with dementia and their carers living in Africa   "
80711|NCT02229461|"     To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory     effect of a low dose Immediate Release Aspirin (IR ASA) regimen.   "
80712|NCT02229448|"     Immunoglobulin G4-related disease (IgG4-RD) is an increasingly recognized syndrome of unknown     etiology comprised of a collection of disorders that share specific pathologic, serologic,     and clinical features.      Histopathological analysis of biopsy specimens remains the cornerstone in the diagnosis of     IgG4- related disease. Elevated concentrations of IgG4 in tissue and serum are helpful in     diagnosing IgG4-related disease, but neither one is a specific diagnostic marker. Correlation     with specific histopathological findings is essential, regardless of the serum IgG4     concentration, the number of IgG4-positive plasma cells in tissue, or the ratio of IgG4 to     IgG in tissue. Misdiagnoses of IgG4-related disease are increasingly common because of     excessive emphasis on moderate elevations of serum IgG4 concentration and overreliance on the     finding of IgG4-positive plasma cells in tissue.   "
80798|NCT02228330|"     The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg     jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of     obturator nerve block in the prevention of inadvertent muscle spasm, and to identify     predictors for both the jerking reflex and successful nerve block.   "
84316|NCT02182388|"     The objective of this trial was to investigate the safety, tolerability, pharmacokinetics,     and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral     dosage form (tablets) without and with food.   "
80713|NCT02229435|"     Statement:      Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate     (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula     and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo     nephrological and urological care (diagnosis and treatment) to prevent chronic kidney     failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes     Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European     Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD.     Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD     should be treated and the medical care should be optimized.      Hypothesis:      Not all patients with CKD receive urological and nephrological care. Interdisciplinary work     of outpatient working urologists and nephrologists in the metropolitan area Magdeburg /     Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment     connection of CKD patients for an orientating statement is needed.   "
80714|NCT02229422|"     We hypothesize that GA101 - Obinutuzumab in combination with HDMP is well tolerated and will     induce similar if not higher response rates than the ones observed in Rituximab plus HDMP     studies (Castro et al., 2009, Castro et al., 2008).   "
80715|NCT02229409|"     This study evaluates the product Walkadoo to determine whether it effectively increases     walking behavior in healthy adults.   "
80716|NCT02229396|"     Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,     Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous     administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)     compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes     who have inadequate glycemic control on metformin.   "
80717|NCT02229383|"     Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel     group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added     to titrated basal insulin glargine with or without metformin to placebo added to titrated     basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus     (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added     to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added     to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the     28-week treatment period.   "
80718|NCT02229370|"     To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The     aim of this study is to collect data on ECAA and its treatment to assess the natural history     of ECAA and the success and safety of different treatment strategies.   "
80719|NCT02229357|"     This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose     between subjects previously vaccinated with LAIV H5N2 and naïve subjects   "
80720|NCT02229344|"     The purpose of this study is to describe clinical course of newly diagnosed moderate to     severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral     hospitals in Korea for 5-year follow-up under usual care.   "
80721|NCT02229331|"     Haemophilia is a rare X chromosome-linked coagulation disorder resulting from a congenital     deficiency or absence of circulating factor VIII (Haemophilia A) or factor IX (Haemophilia     B).As a consequence, patients with haemophilia are unable to generate adequate thrombin     resulting in abnormal bleeding. Approximately 80-90% of bleeding episodes occur in the     musculoskeletal system, especially in the large synovial joints and muscles. Repeated     haemarthrosis induce joint cartilage damage and irreversible degenerative joint disease.      Regular intravenous administration of coagulation factor concentrates starting after the     first joint bleed and/or before the age of 2 ('primary' prophylaxis) is now the     evidence-based, first-choice treatment in children with severe haemophilia. This primary     prophylaxis has radically decreased the incidence of arthropathy in patients with     haemophilia. Despite the positive effect of primary prophylaxis on arthropathy at several     joints, the ankle joint seems to be an exception to the rule, as patients with haemophilia     treated with primary prophylaxis still experience ankle arthropathy. As such, the ankle now     is the main affected joint in patients with haemophilia under the age of 20. This makes the     scientific community facing a new challenge. Determining aetiologic/contributing factors     associated to the ankle arthropathy pathophysiological cascade in children with haemophilia     (CwH) is therefore a primary objective in the haemophilic research community nowadays.      Loading of the ankle is crucial as the ankle plantar flexors provide the main propulsive     power during gait, the tibiotalar joint caries a complex distribution of joint stresses as a     consequence of talar morphology and kinematics and, from a biomechanical and biochemical     viewpoint, differs significantly from other major lower limb joints. Previous biomechanical     studies focused on kinematic and strength measures, however, they omitted to incorporate     fundamental measures of joint loading (joint kinetics) and joint structural integrity (JSI,     assessment of soft tissue and osteochondral integrity through MRI). This makes it impossible     to draw firm conclusions on biomechanical contributing factors. Furthermore, few, low-quality     studies focused on conservative treatment strategies (e.g. strength training, mobilisation,     proprioceptive training) in patients with ankle arthropathy. In a minority of the cases,     important adverse effects (joint bleeding during strength and proprioception training) have     been reported. Because of the low quality of the intervention studies and the lack of     biomechanical studies focusing on joint loading and joint integrity, it is impossible to     pinpoint the aetiology of these side effects. One assumption might be that side effects     originate from inappropriate conservative approaches as a consequence of lacking knowledge on     joint loading and joint integrity.      An innovative approach within the domain of ankle arthropathy in CwH is therefore to study     foot and lower limb kinetics during gait. The quantification of foot joints kinetics     encompasses considerable challenges and, until recently, only simplified single-segment foot     models have been used. Those models typically underestimate the mechanical contribution of     the different foot joints and, of equal importance, overestimate the kinetic contribution of     the tibiotalar joint.      To overcome the above mentioned shortcomings, a valid 3D Multisegment Foot Kinetic Model     (3DMFKM) should be developed and introduced within the population of CwH. This is important     as it allows to quantify increased loading at the tibiotalar joint (or other joints) that may     help to explain this ankle arthropathy in these patients. This will have been missed by     previous research due to the consideration of the foot as one entire segment.      Providing a classification system based on these kinetic data would, in a second stage, be a     pertinent and valuable approach as this provides a rationale for designing randomized     controlled trials.      In this perspective, it is also recommended to assess the relationship with other     biomechanical and anatomical determinants, especially if one aims at developing optimal     management and rehabilitation strategies.   "
80722|NCT02229318|"     Subjects will be asked to substitute their usual vitamin and mineral supplement/s with     FruitiVits for seven consecutive days.   "
80723|NCT02229305|"     This study focused on youths who were referred to community-based mental healths clinics for     problems related to disruptive behaviors, depression, anxiety, traumatic stress, and any     combination of these problems. Therapists were randomly assigned to deliver usual treatment     procedures (usual care, or UC) in their clinics or an evidence-based, modularized treatment     (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct     Problems, or MATCH-ADTC). Assessments were conducted at pre-treatment and post-treatment, and     every 3 to 6 months for two years. Results will address critical questions about deployment     of evidence-based youth practices to clinical settings.   "
80734|NCT02229162|"     This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to     120 seconds) during elective cesarean deliveries of term infants. The investigators     hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this     procedure for mothers and babies.   "
80724|NCT02229292|"     Purpose of the study:        -  To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients          subjected to bi-maxillary orthognathic surgery        -  To evaluate the potential effect of TXA on fibrin structure        -  To evaluate the potential effect of TXA of binding of plasminogen to fibrin        -  To evaluate the potential effect of TXA on postoperative edema formation.      Hypothesis:      H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of     tranexamic acid      H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of     tranexamic acid   "
80725|NCT02229279|"     The objective of this study is to assess the medical and economic relevance of teleconsulting     for Rehabilitation After Hip and Knee Surgical Procedures.   "
80726|NCT02229266|"     The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural     killer cells compared to standard chemotherapy (after first complete remission) in patients     with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for     allogeneic transplantation   "
80727|NCT02229253|"     Patients with prostate cancer and a history of cardiovascular disease treated with degarelix     for their prostate cancer, will be followed for a period of one year. In this real-life,     non-interventional trial, any cardiovascular events occurring during degarelix therapy will     be documented.   "
80728|NCT02229240|"     This Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter,     treat-to-target study of 26 weeks treatment duration will evaluate the efficacy and safety of     once-weekly albiglutide versus placebo as add-on to intensified basal-bolus insulin therapy     (with or without metformin) in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately     450 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide     + intensified basal-bolus insulin therapy (with or without metformin) or placebo +     intensified basal-bolus insulin therapy (with or without metformin. The total duration of a     subject's participation will be approximately 32 weeks.   "
80809|NCT02228187|"     The primary objective is to examine the efficacy of 8-weeks of a locally developed     brain-computer interface based system intervention for improving attention and memory in     healthy elderly and those with age related cognitive decline. We hypothesize that elderly who     have completed the training program will have significant improvement in their attention and     memory compared to the controls, based on the Repeatable Battery for the Assessment of     Neuropsychological Status.   "
80729|NCT02229227|"     This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat     to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of     once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes     mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus     insulin regimen (with or without metformin). Approximately 794 subjects will be randomly     assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with     insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification     of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4     study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and     Post treatment Follow up (4 weeks). The total duration of a subject's participation will be     approximately 36 weeks.   "
80730|NCT02229214|"     The main purpose of this study is measure the effect of VI-0521 on kidney function.     Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of     study treatment, and after an additional 4 weeks of off-treatment recovery.   "
80731|NCT02229201|"     Anaesthesia and surgical stress during craniotomy can lead to brain damage and activation of     inflammatory response. Consequently inflammatory cytokines (IL6, IL8, IL10) are released.     Cell mediated immune balance can increase postoperative complications (infections, wound     healing, multiple organ dysfunction). Many studies have shown that volatile anaesthetics     reduce systemic and local inflammatory response during major surgery, but animal studies have     shown that volatile anaesthetics can induce neuroinflammation (IL6, NF-κB) that leads to     decline of cognitive function in rodent and possible human.      Our aim was to investigate how anaesthetic technique for craniotomy influences the release of     inflammatory cytokines. Our hypothesis was that when optimal neuroprotective strategies are     followed during surgery intravenous anaesthesia attenuates inflammatory response comparing to     inhalational anaesthesia.      The investigators included 40 patients anaesthetised with remifentanil based anaesthesia with     sevoflurane (S group) or propofol (P group).      Plasma levels of IL6, IL8, IL10 were measured during preoperative, perioperative and     postoperative periods of both groups of patients. The investigators also noted emergence     parameters, postoperative (pain, shivering, vomiting) and neurological complications after     surgery.   "
80732|NCT02229188|"     This is a pilot study divided into two phases. IN phase 1 (completed) participants will be     randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a     cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now     recruiting), participants will be randomized to Evo, PST, and a different cognitive training     program called Words. Words is similar to Evo in that it is an adaptive training program and     includes case management. IN both studies participants will be assessed for clinical and     functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.   "
80733|NCT02229175|"     Currently, diabetic macular edema is treated is through injection of a medications such as     off-label bevacizumab, which decreases the swelling in the retina. These injections are     sometimes required monthly until the condition is controlled. Recently, there have been some     new FDA approved treatments using laser that decrease the swelling. These approximately ten     minute treatments do not require injections and don't cause permanent damage to the eye, and     they may decrease the number of injections one needs to get to treat diabetic macular edema     (DME).      The purpose of this randomized clinical trial is to determine whether subvisible laser in     combination with intravitreal bevacizumab is non-inferior compared to current standard of     care (intravitreal bevacizumab alone) in achieving favorable outcomes for visual acuity, mean     macular thickness, and patient quality of life, and has fewer needed intravitreal bevacizumab     injections throughout the course of the 12 month study period.   "
80908|NCT02226900|"     This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid     myocardial revascularization strategy (coronary artery by-pass graft and percutaneous     intervention) in comparison with conventional surgical coronary bypass grafting.   "
80735|NCT02229149|"     This randomized phase 2 study will seek to determine the effectiveness of chemotherapy     (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or     capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus     pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been previously     treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.   "
80736|NCT02229136|"     This is a randomized Phase 2 study to evaluate two different steroid-based mouth rinses     (Miracle Mouth Wash plus hydrocortisone versus prednisolone oral rinse) for the prevention or     treatment of everolimus-associated stomatitis (mouth sores) in postmenopausal patients     undergoing treatment with an aromatase inhibitor plus everolimus. An exploratory analysis     will also evaluate patient response to next anti-cancer therapy of physician's choice     following discontinuation of therapy with an aromatase inhibitor plus everolimus.   "
80737|NCT02229123|"     LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment     strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this     study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam     as first line treatment in term new born babies with seizures. This new anticonvulsivant drug     is a promising treatment for seizures in newborns.   "
80810|NCT02228174|"     The objective of this study is to establish the safety and effectiveness of the Sonata®     System in the treatment of symptomatic uterine fibroids.   "
80811|NCT02228161|"     This study will investigate if yoga exercises decrease work-related stress and improve stress     adaptation in professional health helpers.   "
80812|NCT02228148|"     The purpose of this study is to evaluate if the new and simplified fitting method with     Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the     Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome     as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM     Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles     adjustments, operations which are familiar to anyone who has used an audio player.   "
80813|NCT02228135|"     This is a retrospective chart review looking at the effect of dexamethasone dosing on     post-tonsillectomy hemorrhage.   "
80814|NCT02228122|"     The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic     wound bacterial biofilms   "
80738|NCT02229110|"     Patients with type 2 diabetes mellitus can receive care in the general practice or at the     outpatient clinic. In the region of Amersfoort in The Netherlands, primary care practices and     the hospital are connected through Diamuraal to organize the diabetes care in that region.     They work in the same electronic medical record, and patients can request access to their own     record (called a patient web portal). They set up Diamuraal guidelines, based on the     guidelines of the Dutch College of General Practitioners and Internists, on where the patient     care needs to be allocated (primary or secondary care), depending on the amount of specific     care a patient needs. Despite guidelines, not all patients are treated in the correct place.      Our hypotheses is that when we improve triage we can cause a major shift from treatment in     secondary care to primary care and from primary care to self-care by using the patient web     portal. Furthermore, patients who needs extra attention due to problems with their diabetes     or complications can receive this extra attention due to increased e-consultation between     primary care and secondary care and if necessary actually can, during a short time, be     treated by an internist. We hope to achieve this by introducing a signal in the electronic     medical record. This signal allocates patients according to the guidelines and warns a     physician if their patients is not treated according to that guideline. The health care     provider can then discuss this situation with his patient. We believe that this leads to     shift in allocation of care, in which optimal care is provided and patients are made more     aware of their situation which hopefully leads to better self-management and satisfaction.   "
80739|NCT02229097|"     A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a     better coordination of meal boluses and post prandial basal rate could reduce the importance     of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.      The aim of the investigators study is to assess if these results are confirmed in a clinical     trial.      The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses     on postprandial glycaemic control of T1D patients treated with continuous subcutaneous     insulin infusion.   "
80740|NCT02229084|"     The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide     mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients     with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer.      This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to     evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with     neoadjuvant chemotherapy and (2) to determine if the pCR rate among ER-positive breast-cancer     patients treated with the combination is significantly higher than the 8% rate observed among     ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials.     P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with     neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive     breast cancer.   "
80741|NCT02229071|"     This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and     receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients     wiht advanced hepatocellular carcinoma (HCC) .   "
80742|NCT02229058|"     The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin     Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric     cancer.   "
80743|NCT02229045|"     The purpose of this study is to evaluate the effectiveness and safety of albumin bound     paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients     with advanced gastric cancer.   "
80766|NCT02228746|"     Clinical intervention on overweight or moderately obeses adults. The objective of this trial     is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a     low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in     cardiometabolic risk factors through the intervention have been evaluated as secondary     endpoints   "
80744|NCT02229032|"     There is tremendous curiosity about medical marijuana and the treatment of epilepsy. In a     specific genetic epilepsy known as Dravet Syndrome, a mutation occurs affecting the SCN1A     gene. A specific strain of marijuana known as Charlotte's Web, available in Colorado, may     have activity in this catastrophic epilepsy syndrome. Anecdotal reports suggest both success     and lack of response with this therapy. Genetic analysis of the differences between Dravet     responders and non-responders may prove useful for identifying patients likely to be helped     by this therapy, as well as shed light on the putative mechanisms by which marijuana may     exert any antiepileptic effect.   "
80745|NCT02229019|"     The Southampton Mealtime Assistance Study aims to determine whether it is feasible and     acceptable to introduce trained volunteers as mealtime assistants in five different     departments of one large hospital.   "
80746|NCT02229006|"     The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron     Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of     abdominal aortic aneurysm expansion.   "
80747|NCT02228993|"     Awake craniotomy (AC) is an anesthetic and surgical technique commonly used to resect tumors     involving or adjacent to the eloquent or motor cortices, those portions of the brain that are     responsible for language and motor skills, respectively. By mapping those areas of the brain     that are necessary for such functions, the neurosurgeon is able to avoid resection of     cortical tissue that might compromise the patient's abilities to speak or move, hence     preserving neurologic function. AC is often accomplished by direct cortical stimulation or     inhibition, while maintaining the patient's ability to interact with the operative team. The     anesthetic technique often involves a regional (scalp) block combined with intraoperative     intravenous mild sedation. In some reported instances of AC, no cortical mapping is     performed, and the technique is performed solely because it is thought that AC leads to a     better recovery profile (less pain, better neurologic outcome, and shorter hospital stay)     than craniotomy performed under general anesthesia.      The Quality of Recovery Score (QoR-40) is a validated, multi-parameter instrument that has     been used in various postoperative populations to assess the overall satisfaction and     well-being of patients having undergone anesthesia and surgery. Leslie et al. have reported     that the QoR-40 is a valid tool in assessing neurosurgical patients, but a direct comparison     between AC patients and general anesthesia craniotomy (GAC) patients using this tool has     never been performed.      AC may also be associated with better 30 and 90 day multi-parameter outcomes than GAC. The     well-validated Acute Short Form (SF-12) health survey, an abbreviated version of the SF-36,     consists of 12 items. It measures two domains, including mental and physical component     summaries (mental component summary and physical composite score, respectively).      Hypothesis:      Awake craniotomy for tumor resection is associated with a better multi-parameter quality of     recovery in the immediate postoperative period, and better 30 and 90 day quality of life     outcomes, than craniotomy performed under general anesthesia.   "
80748|NCT02228980|"     The main purpose of this trial is to describe the product profile in terms of immunogenicity     and safety following administration of trivalent influenza vaccine (split-virion,     inactivated) produced at Shenzhen (SP Shz TIV).      Primary objective:        -  To describe in each group the immune response induced by a single dose (subjects aged ≥          3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.      Secondary objective:        -  To describe in each group the safety profile of the vaccine after a single dose          (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35          months).   "
80749|NCT02228967|"     An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be     adapted for use in a large military hospital setting, and then pilot tested in a military     emergency department (ED) to assess its potential for effectiveness and for further testing     in a large-scale trial. SBIRT is an opportunistic approach whereby all adult patients in     the ED are screened by Health Educators for their alcohol use, and then, taking advantage of     a teachable moment, are delivered a brief, motivational intervention matched to their level     of risk.      The feasibility/formative research activities in the first phase (Phase I) of the study are     not summative research, and therefore, do not lend themselves to testable hypotheses.     Hypotheses with regard to the pilot randomized trial in Phase II are as follows:        1. Participants in the SBIRT intervention will show relatively greater reductions over a          six month period (or less increase) than the brochure/usual care control group in the          prevalence of past-month heavy drinking, frequency of heavy drinking, past week number          of drinks, and the AUDIT-based drinkers' index.        2. Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy          will show greater change in the SBIRT intervention group relative to the brochure/usual          care control group.           In addition, exploratory analyses will examine the following:        3. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of          service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline          readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.   "
80750|NCT02228954|"     Rationale. In part of the patients with good and intermediate risk metastatic renal cell     carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is     not necessary. By now, the investigators are not able to identify those patients with     indolent disease and the minor group of patients with rapidly progressive disease. In     patients with indolent disease, a watchful waiting period is preferred, since their quality     of life will not be unnecessary hampered by adverse events and therapy resistance is not     induced. This study aims to identify those patients for whom a watchful waiting period is     possible by molecular imaging. Furthermore several types of systemic therapy are possible     once the progression is proven. These systemic treatments are comparable in terms of     efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary     objective, the usefulness of a decision aid guiding the choice of the patients is studied.      Objectives.      To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful     waiting, the added value beyond clinical work-up of:        1. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid          progression (≤ 2 months after the baseline scan) under watchful waiting.        2. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged          indolent (≥12 months after the baseline scan) disease under watchful waiting.      To assess the value of a therapy choice decision aid for patients with progressive disease.      Study design. This is a multicenter non-blinded prospective observational study in 80 good     and intermediate prognosis mRCC patients.      Study population. Patients with good or intermediate prognosis mRCC according to the Heng     criteria, ≥18 years, without contra-indications for a watchful waiting period, able to     provide informed consent.      Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the     watchful waiting period, disease evaluation by CT according to the RECIST criteria will be     made frequently, until established progressive disease. At that moment, a second FDG-PET-CT     and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second     89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to     choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α     with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy     (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a     separate phase II study.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness.      At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the     watchful waiting period CT's will be made. During therapy, follow-up will include standard     laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects of     the medication and adverse events as a consequence of the tumor biopsies may occur. The     radiation exposure of both PET investigations is acceptable and requires no shielding after     injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or     stabilization. All three treatment choices has proven clinical benefit in this patient     population. The risks of participation into the RIT trial are described in the phase II trial     protocol, which already has been judged by the Medical Ethics Review Committee.   "
80751|NCT02228941|"     Hyper IgE syndrome (HIES) is a rare and complex primary immunodeficiency that affects     multiple systems. It is characterized by elevated Immunoglobulin E(IgE), recurrent skin and     pulmonary infections and eczematoid dermatitis.Somatic manifestations include scoliosis,     joint hyperextensibility, impaired shedding of deciduous teeth and facial dysmorphism.      The reason of extremely high level of serum IgE in the patients with HIES is unknown. Signal     transducers and activators of transcription 3(STAT3) gene mutations can cause the STAT3/Janus     kinase(STAT3/JAK) signal transduction pathway disorder, then can affect the B cell     development.      It is reported that levels of extracellular signal cytokine and the prolonged half-life of     IgE are not the causes of dramatically increased IgE levels in STAT3-HIES patients. According     to our preliminary work, we found that the slight increase of IgE-secreting plasma cells     could not explain the tremendously increased IgE level and that the key class switch     recombination enzyme (AID) was up-regulated in STAT3-HIES patients. Intriguingly, we found     that deregulation of immunoglobulin class switch recombination (CSR) in IgE secreting plasma     cells in STAT3-HIES patients might play a key role in dramatically increased IgE levels.      Nuclear factor IL-3 regulated (NFIL3) is a newly discovered transcriptional factor. During     STAT3-HIES IgE-secreting plasma cells differentiating, NFIL3 was significantly upregulated.     The CSR of IgE was down-regulated in STAT3-deficiency mice as well as NFIL3-deficiency mice,     however Interleukin-4（IL-4）, a STAT3-independent cytokine, promotes NFIL3 expression by     Signal transducers and activators of transcription 6(STAT6) dependent manner. Thus, we     hypothesize that NFIL3 may play a key role in dramatically increased IgE levels in STAT3-HIES     patients.      In-depth insight of the pathogenic role of NFIL3 within human STAT3-HIES has great     significance in clarifying the pathogenesis of HIES and exploiting effective targeting     interventions to improve clinical outcomes. Also, it can provide valuable clues for the     clinical treatment of IgE-related diseases, such as parasite infection and malignant     diseases.   "
80752|NCT02228928|"     The efficacy and safety of the low concentration [0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)]     capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch     in patients suffering from peripheral neuropathy   "
80753|NCT02228915|"     The purpose of this research study is to discover and quantitate the differences in     post-translational modifications found in the Cu, Zn superoxide dismutase (SOD1) of patients     with amyotrophic lateral sclerosis (ALS) as compared to healthy individuals. SOD1 is a known     genetic cause of ALS. With certain mutations, SOD1 gains a toxic function which leads to     motor neuron death.   "
80754|NCT02228902|"     Introduction: There are indications that the absorption of oral iron supplementation is     reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as     standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric     bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to     a insufficient treatment of oral iron suppletion.      Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients.     Two groups will be created.      Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives     a daily dose Losferron (1390mg).      Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron     including ferritin, transferrin and transferrin saturation will be measured. After intake of     losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after     intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron     absorption. All patients undergo a Roux- en -Y gastric bypass.      Postoperatively; one month postoperatively the same absorption test will be repeated in the     same patients.   "
80755|NCT02228889|"     The purpose of the study is to compare the clinical outcomes of two commonly used,     FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice     and XenMatrix). The two meshes are derived from pig skin from which cells have been removed     and which have been sterilized. The two meshes are made by two different companies using     different processes.   "
80756|NCT02228876|"     This 3-year proposal is a family-based cohort study to establish a representative sample of     probands with ASD and their parents with well-characterized environmental, clinical     phenotypes, endophenotypes, and genetic data to conduct CNV experiments and the     genotype-phenotype correlations. Based on our previous findings, probands with CNVs larger     than 500kb has been identified and their families will be newly recruit in the present     project to reveal the origin of the CNVs and reveal the clinical feature of the families. The     significant findings in specific genes will conduct pathway analysis to reveal the etiology     in ASD, providing further understanding in the disease.   "
80757|NCT02228863|"     Concomitant use of botulinum toxin and robot would make better results regarding upper     extremity function compared to robot, botulinum toxin, or no intervention.   "
80758|NCT02228850|"     The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a     diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).   "
80827|NCT02227953|"     The primary objective of this preliminary study is to investigate whether the transcranial     direct current stimulation (tDCS) improves the cognitive function in patients with     Alzheimer's disease   "
80897|NCT02227043|"     The investigators will study the influence of fat cell size/number and adipose function on     weight development over very long time periods (years). By comparing fat biopsies obtained at     baseline and after >7 years, the investigators will determine the association between adipose     morphology/function and changes in weight or development of cardiometabolic complications     (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).   "
80759|NCT02228837|"     The hypothesis of this study is that the daily consumption of 2 medium-sized pears for twelve     weeks will improve blood pressure, lipid profiles, glycemic control and insulin resistance,     inflammatory and oxidative status in men and women with metabolic syndrome. 50 men and women     between the ages of 45 and 65 who have three of the five features of metabolic syndrome as     defined by the Adult Treatment Panel III will be included in the study. After a two-week     run-in phase, eligible men and women will be randomly assigned to one of two treatment     groups: 1) 2 medium-sized pears; or 2) 50 g placebo powder daily for twelve weeks. After an     initial telephone screening, all participants will be requested to report to the study site     for their first visit. On the first visit (screening), participants will be provided with     verbal and written explanation of the project. They will then be asked to sign an informed     consent form, followed by measuring waist circumference, resting brachial blood pressure,     fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to     confirm metabolic syndrome. Baseline assessments will be performed for medical history,     medication use, dietary intake, and physical activity. Qualified participants will be     scheduled for their second visit two weeks later (actual baseline data collection) and     randomly assigned to their treatment group. On the second (baseline) visit between the hours     of 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.     Anthropometrics and body composition will be measured. Questionnaires regarding diet,     physical activity, and gastrointestinal health will be performed. Participants will be     provided with their assigned treatment and will receive standard instructions on how to fill     out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),     and 12-week (final visit) intervals. All assessments and information will be collected after     an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the     last bout of moderate to heavy physical activity. After the initial 12 weeks, participants     will undergo a 4-week washout period in which they will not consume either the intervention     or the placebo. After the 4-week washout period, participants will crossover into the other     group to receive either the intervention or placebo.   "
80760|NCT02228824|"     The purpose of this research study is to investigate the impact of different nicotine levels     in cigarettes among non-daily smokers. This research may help inform the Food and Drug     Administration (FDA) on how best to regulate tobacco products in the future, with the goal of     improving public health.   "
80761|NCT02228811|"     The main purpose of this study is to investigate the safety of the investigational drug     DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer     that has spread to other parts of the body.   "
80762|NCT02228798|"     The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to     establish a safe, standardized protocol for the perioperative management of patients with     atrial fibrillation (AF) who are receiving a novel oral anticoagulant (DOAC) drug, either     dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.   "
80763|NCT02228785|"     This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg,     500µg) of G17DT for the treatment of patients with colorectal cancer.   "
80764|NCT02228772|"     This research study is evaluating a combination of drugs considered standard treatment for     children and young adults with acute lymphoblastic leukemia (ALL), in combination with a new     drug called MLN 9708. Additionally, the study is also evaluating if bone marrow or stem cell     transplantation, which will be given to some participants, helps to prevent ALL from     returning.   "
80765|NCT02228759|"     Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks     with continuous adductor canal block along with multimodal analgesia started pre-operatively     and continued into the postoperative period. The study will evaluate the feasibility of home     discharge within the first 24 hours following total knee arthroplasty. We will also evaluate     the pain scores in the first 5 days following the surgery, causes of delayed discharge and     any adverse events.   "
84139|NCT02184689|"     The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole     (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping     sickness in children at least 6 years old and over 20 kg bodyweight.   "
80767|NCT02228733|"     This single ascending dose (SAD) study in healthy subjects will evaluate the safety,     tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and     urine albumin levels) relationships will be explored to support the selection of dosing     regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the     efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of     nephropathy as well as control hypertension.   "
80768|NCT02228720|"     This is a feasibility study is to assess the performance, safety and initial signals of     efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis     patients undergoing sinus surgery of peripheral sinus ostia.   "
80769|NCT02228707|"     The primary objectives of the study are to evaluate the safety and tolerability of multiple     doses of BIIB061 administered to healthy adults. The secondary objective is to determine the     multiple-dose PK profile of BIIB061 in this study population.   "
80770|NCT02228694|"     An automated dispensing cabinet (ADC) is a computerized drug storage device or cabinet     designed for hospitals. ADCs allow medications to be stored and dispensed near the point of     care while controlling and tracking drug distribution.This study seeks to obtain quantitative     measurements of the impact of the regulated ADC System installed in select high volume units     throughout the hospital.   "
80771|NCT02228681|"     The main purpose of this study is to evaluate the effectiveness of the combination of the     drugs Everolimus and Letrozole compared to Tamoxifen and Medroxyprogesterone acetate in     treating endometrial cancer and to determine the types and severity of side effects caused by     treatment with these drug combinations.   "
80784|NCT02228512|"     Background:      - The chemotherapy combination DA-EPOCH-RP includes the drugs etoposide (E), prednisone (P),     vincristine (O), cyclophosphamide (C), doxorubicin (H), rituximab (R), and pomalidomide (P).     Researchers want to see if including pomalidomide will help people with two rare lymphomas.      Objectives:      - To study the safety and efficacy of the chemotherapy drugs DA-EPOCH-RP.      Eligibility:      - Adults at least 18 years old. They must have primary effusion lymphoma or large cell     lymphoma arising from Kaposi sarcoma Herpesvirus-associated multicentric Castleman disease.      Design:        -  Participants will be with screened with blood tests, scans, spinal tap, and bone marrow          sample. They may have skin or lymph node samples taken and fluid removed from around          some organs.        -  Participants will have breathing and eye tests. A camera may take pictures inside their          body.        -  Participants will take pomalidomide alone by mouth for up to 21 days. Then they will get          rituximab by intravenous (IV) catheter, which is a small tube that goes into a vein..        -  Participants will have an IV inserted in an arm or chest vein to get the IV chemotherapy          drugs, at the same time the will take pomalidomide by mouth for 5 days.        -  They will get DA-EPOCH-RP in 21-day cycles. Most people will have 6 cycles.        -  They will get 4 study drugs by IV for 5 days and 2 others by mouth for 5 days.        -  They will get daily filgrastim injections in the skin until white blood counts are          acceptable        -  For 2 days of some cycles, methotrexate will be injected into the spinal fluid.        -  After completing EPOCH-RP, some participants who have Kaposi sarcoma will be prescribed          pomalidomide for 3-weeks, followed by a one week break, for up to 12 months.        -  Participants will repeat the blood tests often. They will also have repeated medical          history, physical exam, urine and stool tests, and pictures of any rashes associated          with these lymphomas.        -  Participants will have several follow-up visits over 4 years.   "
80898|NCT02227030|"     Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL   "
80772|NCT02228668|"     The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up     of patients previously included in the AVANT trial from December 2004 to June 2007.      Clinical data of the AVANT trial will be updated. Neither additional examination nor     administration of any treatment will be performed on the patients.      330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium,     Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece,     Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway,     Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden,     Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).      The AVANT study aiming at demonstrating superiority of bevacizumab in combination with     FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when     adding bevacizumab to chemotherapy in resected stage III colon cancer.      Adverse events were consistent with the known safety profile of bevacizumab. However, more     relapses and deaths due to disease progression have been observed in both bevacizumab arms.      A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term     results and safety.      Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected     at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median     follow-up (expected to be reached around Q2 2016).      All analyses will be performed on an exploratory purpose only. An analysis at 8 years median     follow-up and a final analysis at 10 years median follow-up will be performed in the main     population (all randomized patients in the AVANT trial including patients lost to follow up     or died).   "
80773|NCT02228655|"     FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.   "
80774|NCT02228642|"     Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at     risk for losing the ability to develop symptoms that warn them that they are having a low     blood sugar. There is almost no available information investigating how the inability to feel     symptoms of a low blood sugar contributes to the risk of this happening when people with     diabetes are hospitalized. The purpose of this study is to develop a symptom score model that     will help to identify patients at risk for low blood sugars in the hospital and to examine     what happens to patients who do experience a low blood sugar in the hospital.   "
80775|NCT02228629|"     Foot complications are a common and costly problem for subjects with diabetes. Although     Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not     wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such     as flip flops or slippers, that provide little to no protection against injuries. While     proper house shoe is important in the prevention of diabetic foot complications, this area     has not received much attention. The purpose of this pilot study is to assess if CrocsRx     Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles,     and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to     conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design     will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with     the order of shoes randomized.   "
80790|NCT02228434|"     The project aims at developing the tailored intervention strategy of childhood obesity based     on monitoring physical activities with accelerometer and dietary behaviors using diary. It     probably raise the passion of obese children to control weight, form healthy life style, be     effective in sustaining weight loss and early prevent adulthood diseases.   "
80776|NCT02228616|"     The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once     daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic     Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the     percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel     movements (SCBMs) (responders) during the 12-week treatment phase as compared to the     baseline.   "
80777|NCT02228603|"     Exercise training is a core component in cardiac rehabilitation. Exercise adherence is,     however, low after rehabilitation and the transition from supervised to unsupervised exercise     is problematic for many patients with coronary artery disease. Therefore, it is important to     provide extended services to improve exercise adherence and healthy lifestyle changes.      The aim of this study is to assess the effect of a time-limited intervention following     out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.   "
80778|NCT02228590|"     The primary objective of this study is to evaluate the efficacy, tolerability and safety of     single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)   "
80779|NCT02228577|"     This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted     using the Model 241 Applier. The objective of this study is to characterize and evaluate the     safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.   "
80780|NCT02228564|"     Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™     Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.   "
80781|NCT02228551|"     This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a     measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically     ill abdominal and trauma surgery population. Secondary objectives are the identification of     risk factors associated with ARC in this specific study population.   "
80782|NCT02228538|"     The purpose of this study is to obtain patient oriented and clinically oriented physical     function outcomes both pre-operatively and post-operatively in patients receiving a total     knee arthroplasty.   "
80783|NCT02228525|"     The purpose of this study is to see if selinexor will improve the blood counts and bone     marrow function in people with your type of MDS.   "
80796|NCT02228356|"     The investigators recently published 2 phase II trials on the use of helical tomotherapy for     oligometastatic colorectal cancer [1,2]. Despite a dose increase from 40 to 50 Gy, delivered     in 2 weeks time, the one-year local control was 54% only [1,2]. The high local failure rate     is probably the result of geographical misses due to tumor motion and a biologically     effective dose (BED) of < 100 Gy. The current study will investigate whether the one-year     local control rate can be improved to 70%, using respiration correlated CT to individualize     the margin needed to account for tumor motion, to avoid geographical miss, together with a     Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose,     allowing higher doses in the tumor core. As the concept of an internal target volume (ITV)     may result in large margins for patients displaying metastases in high mobile organs, such as     liver and lung, which may lead to exposure of a relatively high dose to a large volume of     normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those     patients.   "
80785|NCT02228499|"     Background: Asthma is the most common chronic disease of childhood with a prevalence that is     1.6 times greater in African American (AA) children than in Non-Hispanic White children.1     Nationally, 700,000 children are seen for asthma in Emergency Departments (ED) every year, 1%     of which are seen at Children's National Health System (CN) in Washington, DC. School     performance and school attendance has not been well studied in urban children with asthma,     especially at the middle school level.      Objective: Our purpose is to test the hypothesis that middle school children with asthma have     worse school performance than middle school children without asthma in Washington DC and     Prince George's county schools.      Methods: The investigators will conduct a cross-sectional observational study of     middle-school (grades 6-8 in the 2013-2014 school year) aged children with and without asthma     recruited from the Emergency Departments and the IMPACT DC asthma clinic at CN. The     investigators will collect demographic information, asthma severity information (for cases),     and request that parents mail report cards and standardized test scores directly to the     investigators. The investigators will use multivariable linear and logistic regression to     determine if the presence of asthma is associated with school performance.   "
80786|NCT02228486|"     Relapse is a major risk in substance abuse disorders, which is closely related to craving for     a substance, describing a strong urge for consumption. Cue-exposure therapy is an     intervention aiming at the reduction of perceived craving by repeated confrontation. It is     based on the assumption that craving drops after repeated exposure without the reinforcing     experience elicited by consumption. In the present study, patients with alcohol dependency     take part in nine cue-exposure training sessions. Each session consists of mood induction     reflecting a high risk situation with subsequent in vivo confrontation with one's preferred     alcoholic beverage followed by the training of coping strategies. During the cue-exposure,     patients focus on perceiving automatic responses to alcohol-related cues. We hypothesize that     especially patients exhibiting initially high reactions to such cues should profit from this     intervention the most. The reactions are measured on a subjective (craving) and physiological     level (hemodynamics of the prefrontal cortex, heart rate variability, electrodermal     activity). Furthermore, we want to strengthen the expected training effects during the     cue-exposure by an activating transcranial direct current stimulation of the dorsolateral     prefrontal cortex, which has been shown to be hypoactive in substance abuse disorders. We     investigate how the cue-exposure training affects the processing of alcoholic cues     (cue-reactivity) and its relation to clinical symptoms of alcohol dependency.   "
80787|NCT02228473|"     We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of     catheter-related bladder discomfort.   "
80788|NCT02228460|"     Primary Objective:      To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy     of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male patients diagnosed     with Fabry disease.   "
80789|NCT02228447|"     The purpose of this study is to evaluate the impact of a multicomponent school-based     intervention based on Bandura's Social Cognitive Theory targeting healthy eating and physical     activity for high school adolescent girls from low-income communities in the city of São     Paulo, Brazil.   "
80791|NCT02228421|"     This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of     crizotinib and its companion diagnostic test used in a real-life setting in advanced     ALK-positive non-small cell lung cancer (NSCLC) patients.      NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the     ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor     tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC,     the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of     activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK     rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with     adenocarcinoma histology, in never smokers and in those who are known to be wild type for     EGFR and KRAS.      Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+     NSCLC patients. This is an example of personalized medicine, where patients are selected for     treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for     their disease. The pharmacoeconomic impact of using genetic information in early treatment     decisions in NSCLC has not been determined.      The study will enable real-life Heath Economics and Outcome Research (HEOR).      Approximately 90 patients will be recruited. Patients will be asked to complete     quality-of-life questionnaires at regular intervals in a real-life setting of treatment with     crizotinib.   "
80792|NCT02228408|"     This study is a pilot study designed to compare the safety and cardiovascular effects of 26     weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in     patients receiving chronic hemodialysis.      The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a     combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it     will improve heart function as well blood flow/blood vessel supply.   "
80793|NCT02228395|"     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a     number of single ascending doses in healthy volunteers   "
80794|NCT02228382|"     The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to     the European Medicines Agency in providing additional safety and efficacy data in     approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with     high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase     patients in the fourth or later line treatment setting (i.e., after treatment with at least 3     other Tyrosine Kinase Inhibitors).   "
80795|NCT02228369|"     This is the first time in patient study to assess the safety, tolerability and preliminary     efficacy of AZD3759 in patients with advanced Non Small Cell Lung Cancer (NSCLC) In this     study, patients with Leptomeningeal Metastasis and Brain Metastasis may also be enrolled to     assess the anti-tumour efficacy, safety, pharmacokinetics and potential biological activity     of AZD9291   "
80799|NCT02228317|"     A large part of acutely ill patient's access to the health care system starts by calling the     emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch     center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the     hospital. These patients are not referred by a physician (eg. a GP) and represent an     unselected subpopulation of the acutely ill patients. At present, all non-critically ill     patients not evaluated by a pre-hospital physician are normally be transported to hospital as     category 2 (without activated emergency lightning and sirens).A part of this patient     population, however, is not critically ill and a proportion of these may not need hospital     admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave     patients without a physician's involvement. If the EMT had 24/7 online access to medical     control i.e. in form of a physician present in the EMDC , the number of patients transported     to hospital for assessment may be reduced as well as response times for patients actually     needing ambulance transportation. This could potentially reduce the workload on the whole     healthcare system involved in the management of these patients - thereby potentially reducing     costs.      The objective of this study is to evaluate if a systematic telemedical assessment by an     EMDC-physician of all patients who receive an ambulance but are not critically ill and would     have a category 2 transport to hospital can reduce the number of the patients that are     transported to hospital and save costs and time.   "
80800|NCT02228304|"     Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients     treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation     at year 2. Those who, in the opinion of the investigator, are still candidates for continued     anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and     followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate,     randomized, masked phase during which eligible patients will be randomized to the NT-503-3     group or the control group.      Clinical Hypotheses:        -  NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the          prevention of vision loss due to recurrent CNV secondary to AMD        -  NT-503-3 ECT has an acceptable safety profile   "
80801|NCT02228291|"     This randomized, double-blind, placebo-controlled, parallel study aims to determine the     6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and     intestinal health as assessed by investigation of endothelial function, blood pressure and     heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh     subjects.      Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum     levels of specific metabolites of the study product.   "
80802|NCT02228278|"     The purpose of this study is to determine if health-related text messages sent from     healthcare providers to overweight and obese adolescents enrolled at a pediatric lipid clinic     will result in increased adherence to their nutrition and physical activity goals and improve     their weight loss. The study will also assess if the volume of texts per week impacts     outcomes. This will be a small scale pilot study, with plans for a future larger scale study     to assess for statistically significant effects.   "
80803|NCT02228265|"     This research trial studies molecular features and pathways in predicting drug resistance in     patients with castration-resistant prostate cancer that has spread to other parts of the body     and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory     from patients receiving enzalutamide may help doctors learn more about molecular features and     pathways that may cause prostate cancer to be resistant to the drug.   "
80804|NCT02228252|"     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.     Identification of a simple diet-related method will possibly result in reduction of CVD in     healthy as well as high-risk subjects.      The aim of this project is to investigate the effect of protein quality and the time factor     of protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and     apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose,     insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and     metabolomics. Also satiety feeling will be measured.      Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich     isocaloric meal reduces triglyceride- and ApoB48 responses more compared to casein protein     and gluten protein consumed 15 minutes prior to the meal and whey protein consumed 30 minutes     prior to the meal in subjects with MeS.      The investigators research will hopefully contribute to a better understanding of how PPL can     be modified in a simple manner. It will promote innovation to the food industry for     development and production of healthy food products, which can be applied in the fight     against CVD in the background population in general and high-risk people in particular. Thus,     the results of this project can impart knowledge of great importance both to the national and     international food industry as well as the healthcare systems.   "
80805|NCT02228239|"     The purpose of this study is to evaluate the effect of esketamine compared to placebo on     driving performance as assessed by the mean difference of standard deviation of lateral     position (SDLP) from an on-road driving test in healthy participants.   "
80806|NCT02228226|"     Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1     for dislocation of shoulder to evaluate anchor bone hole condition and ossification.   "
80807|NCT02228213|"     The purpose of this study is to determine whether MIS416 administered once weekly over 12     months is safe, tolerable, and improves a range of signs and symptoms associated with     secondary progressive multiple sclerosis.   "
80808|NCT02228200|"     A nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting     was formulated. The aim of the study was to assess the effect of this nurse-led care program     on cancer patients who received neo-adjuvant/adjuvant chemotherapy in a chemotherapy day     center in terms of quality of life, symptom experiences, self-efficacy, health care     utilization, and satisfaction with care. Specifically, the objectives are:        -  To compare the differences of health care utilization between the two arms.        -  To compare the differences of cancer patients' satisfaction with care between the two          arms.        -  To explore the experiences of cancer patients in the intervention arm.        -  To understand the experiences of the intervention nurses of the program and their          opinions on further development.   "
80899|NCT02227017|"     Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg     coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg     coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted     and fed conditions in healthy male and female volunteers.   "
80815|NCT02228109|"     The purpose of this study is to use a corneal topographer, a device that is readily available     in most optometric practices, in order to determine the position of the multifocal (MF)     contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this     study is to evaluate if there is a relationship between the positioning of the optics of the     study lenses and the objective and subjective visual performance as well as participant     satisfaction. The MF CL lenses will be fitted to two groups of participants (previously     unsuccessful vs. currently successful MF CL wearers).      HYPOTHESES        -  The measurement of the power distribution acquired from the Medmont E300 corneal          topographer is effective in determining MF CL lens centration and is a predictor of MF          CL success.        -  There is a difference in MF CL centration, determined by corneal topography, between          successful and unsuccessful MF CL wearers.        -  MF CL centration, determined by corneal topography, is correlated with visual          performance, determined by ocular aberrometry, measures of visual acuity and subjective          satisfaction.   "
80816|NCT02228096|"     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and     safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell     acute lymphoblastic leukemia, who were chemo-refractory, relapsed after allogeneic SCT, or     were otherwise ineligible for allogeneic stem cell transplant.   "
80817|NCT02228083|"     To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.   "
80818|NCT02228070|"     Measuring ocular motility and alignment is important for diagnosing different causes of     strabismus, following patients recovering from cranial nerve palsies, preparing patients for     strabismus surgery and follow-up post surgery. The current clinical gold standards for     measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are     accurate, but require patient cooperation, and are not objective because the patient has to     indicate the position of the light he sees on the screen. Our objective is to develop an     accurate and easy to use goggles system to measure ocular alignment and motility using 3D     video oculography.   "
80819|NCT02228057|"     Injury to the blood vessels of the extremities, and more specifically the arteries, can     result from fractures and severe crush injuries. It occurs in about 3% of the general     population. People affected by blood vessel injuries can have important problems, including     cold intolerance, general pain, and weakened function of the associated limb. Even after     surgical intervention to repair the affected artery, people may still experience numbness,     problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are     particularly relevant in the case of forearm arterial repairs because this repair directly     affects one of our most vital structures: the hand. Despite available interventions and     advances in microsurgical technique, arterial repairs can still result in significant sensory     and functional impairment of the hand. Once an artery within the arm is injured, a surgeon's     primary goal is to restore blood flow to the hand and prevent functional impairment. Even     with a prompt effort to restore hand perfusion, long-term (greater than 6 months) sensory and     motor function is hard to predict.      Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this     occlusion has a direct impact on a patient's perceived pain and cold intolerance at the level     of the hand.      In this study, we are investigating the occurrence of blood vessel occlusion in the arm after     at least 6 months of surgery and the impact of this event. To assess this we will use     physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires.     Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold     Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess     pain, sensory, and motor impairments in both the affected and unaffected hand. Functional     assessments will include 2-point discrimination, grip strength, pinch strength, capillary     refill and range of motion.   "
80820|NCT02228044|"     This study examines whether an integrated alcohol/substance abuse, suicide, and HIV     prevention protocol is associated with lower onset and frequency of alcohol and other drug     use, suicidal behavior, and high risk sexual behavior among adolescents receiving community     based mental health care.   "
80821|NCT02228031|"     The purpose of this project is to investigate the possible effect of intranasally     administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron     system (MNS) is thought to be involved in action perception and understanding, and may also     underlie more complex cognitive processes such as imitation. We will use     electroencephalographic (EEG) investigations to examine brain activity while participants     complete two different tasks, consisting of the observation and imitation of emotional facial     expressions (video presented) and the observation and execution of simple grasping actions     (live presented), respectively. In addition, before the beginning of the EEG recording     session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo     group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is     a polypeptide hormone that plays a critical role in social behavior. We will identify mu and     beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal     directed action perception and imitation/execution.   "
80822|NCT02228018|"     CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in     a group of healthy volunteers and asthma patients.   "
80823|NCT02228005|"     The purpose of this study is to examine the effects of sertraline treatment of depression in     older adults on gait stability, balance recovery reactions, and markers of bone metabolism.     This is a pilot study that will determine feasibility and generate hypotheses for a larger     definitive study.   "
80824|NCT02227992|"     The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant     Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft     tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and     thoracic (non-cardiac) surgery in paediatric patients.   "
80825|NCT02227979|"     The proposed study is designed to investigate whether the PURPLE Crying program attains     efficacy by optimizing the neural response in the anterior insula, and augmenting activity in     regions of the brain known to be important for emotion regulation.      The aim is to determine the effects of the PURPLE Cry Intervention by investigating the     following:        -  independent variables that may affect a father's neural response to infant cries        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'          reported aversiveness and empathy in response to cry stimuli        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'          neural response to unknown infant cries compared to a tone control        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'          neural responses to own infant cries compared to unknown infant cries      The investigators hypothesize:        -  prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be          modulated by the following variables: subjective self-reported emotional reaction to cry          stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant          temperament, life stressors, parental expectations, personality (neuroticism), and          father's own childhood experience        -  fathers who receive the PURPLE material compared to those that receive the control          intervention will report a larger decrease in aversiveness and a larger increase in          empathy in response to cry stimuli        -  fathers who receive the PURPLE material compared to those that receive the control          intervention will show a larger decrease in activity in the anterior insula and amygdala          in response to cry stimuli        -  fathers who receive the PURPLE material compared to those that receive the control          intervention will show a larger increase in activity in regions of the brain important          for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and          orbitofrontal PFC        -  fathers' neural activity in the amygdala in response to their own infant's cry stimuli          will be positively correlated with both their own and infant testosterone levels   "
80826|NCT02227966|"     The primary objective of this preliminary study is to investigate whether the transcranial     direct current stimulation (tDCS) improves the cognitive function in patients with Mild     Cognitive Impairment (MCI)   "
80828|NCT02227940|"     This phase I trial studies the side effects and best dose of ceritinib and combination     chemotherapy in treating patients with solid tumors that have spread to other places in the     body and usually cannot be cured or controlled with treatment (advanced) or pancreatic cancer     that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or     has spread to other places in the body (metastatic). Ceritinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation,     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving     ceritinib and more than one drug (combination chemotherapy) may be a better treatment for     solid tumors or pancreatic cancer.   "
80829|NCT02227927|"     Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux     disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.      This is a long-term treatment program for prescription of this drug to all patients who, in     the investigators' judgement, could benefit from its use.   "
80830|NCT02227914|"     The purpose of Phase 1b of the study is to determine the maximum tolerated dose,     pharmacokinetics (PK) and pharmacodynamics (PDn) and assess the safety, tolerability and     activity of oprozomib in combination with sorafenib in subjects with advanced hepatocellular     carcinoma (HCC).      The purpose of Phase 2 of the study is to evaluate the efficacy of oprozomib in combination     with sorafenib versus sorafenib alone and to compare the key outcome measures for subjects     with advanced HCC.   "
80831|NCT02227901|"     This phase I trial studies the side effects and best dose of tipifarnib when given together     with radiation therapy and temozolomide in treating patients with newly diagnosed     glioblastoma multiforme. Tipifarnib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor     cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving tipifarnib together with radiation therapy and     temozolomide may be a better way to treat glioblastoma multiforme.   "
80832|NCT02227888|"     This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the     pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to     identify an initial starting dose for Phase 2 trials.   "
80833|NCT02227875|"     To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily     (both administered in combination with other anti-diabetic drugs) based on the change in     HbA1c from baseline to 24 weeks   "
80834|NCT02227862|"     To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily     (based on change in HbA1c from baseline to 24 weeks) when administered in combination with     mealtime insulin lispro.   "
80835|NCT02227849|"     The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284)     in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.   "
80836|NCT02227836|"     Can allergy patch test (APT) predict of dietary therapy in patients with Eosinophilic     Esophagitis?   "
80837|NCT02227823|"     The purpose of this study is to evaluate safety and efficacy of anti-cholinesterase therapy     on the motor function in SMA type 3 patients with impaired neuromuscular junction (NMJ).   "
80838|NCT02227810|"     Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong     mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days     of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients     with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of     this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics     and hospitalization outcomes in patients with PMV.   "
80839|NCT02227797|"     The primary purpose of this study is to identify the optimal dose of voriconazole, an     anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level     is one level that provides a good blood level (concentration) of voriconazole without too     much toxicity.   "
80840|NCT02227784|"     The purpose of the ACCENTUATE study is to evaluate whether the study drug known as     evacetrapib is effective in treating participants with high cholesterol and atherosclerotic     cardiovascular disease (ASCVD) and/or diabetes.   "
80841|NCT02227771|"     The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy     stent should minimize the risk of late aneurysm formation and potential clinical     complications but not at the cost of enhanced efficacy.   "
80842|NCT02227758|"     The purpose of this study is to evaluate the long-term safety and performance of     neurostimulation for the treatment of intractable chronic migraine as well as to detect     infrequent complications or problems only apparent in real-world practice   "
80851|NCT02227641|"     In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses     such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening     complication requiring antiviral treatment. The underlying problem is a severe suppression of     the donors immune system after transplantation into the patient. Herpesviruses such as CMV     and EBV persist after primary infection life long in the host and therefore require constant     immunological control. This control is largely provided by the T-cell compartment of the     immune system. After allogeneic stem cell transplantation the T-cell compartment requires a     long time for its reconstitution since only a small fraction of the donor T-cells are     transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell     control.      This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific     T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a     phase I study to demonstrate that these in vitro generated T-cells can be applied safely in     this patient population. The study also aims at demonstrating the efficacy of CMV/EBV     specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis     is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host     disease and that they successfully prevent reactivation of CMV and EBV after adoptive     transfer in patients after allogeneic stem cell transplantation.   "
80843|NCT02227745|"     Photocoagulation is the standard treatment in the focal EMCS, disrupts vascular leakage and     allows the pigment epithelium remove the intraretinal fluid is effective in reducing the     incidence of visual loss but can reduce contrast sensitivity and retinal sensitivity, the     characteristics of the function can be reduced such as setting (location and stability) are     relevant to the quality of the patient's vision parameters, reading comprehension, especially     the ability, duration of diabetic macular edema, could have a significant impact on survival     and / or the functional reserve of the macular cells subjected to mechanical and toxic     stress-induced edema. It seems that in the treatment of patients with EMCS, photoreceptor     damage occurs as a recent phenomenon, and can precede neurodegeneration retinal photoreceptor     loss, whereby visual function can be decreased. An adjunctive treatment as Dorzolamide     facilitating effect helping resorption of intraretinal fluid through EPR and reduce adverse     events that is the loss of contrast sensitivity and retinal sensitivity, response time of     photocoagulation treatment could be reduced to the patient, because the rate of resorption of     intraretinal fluid is facilitated and thus the duration of the response, also could reduce     damage to vision caused by the inadequacies of the photoreceptors during the evolution of     macular edema avoiding moderate visual loss, there by increasing the quality of life in terms     of improving the quality of vision in diabetic patients. In addition to obtaining a specific     adjuvant treatment with photocoagulation is helpful for focal edema in diabetic and a new     level using dorzolamide in retina Dorzolamide as adjunctive therapy after focal     photocoagulation is more effective than placebo in improving visual function in patients with     diabetic macular edema   "
80844|NCT02227732|"     The purpose of this study is to determine whether a new catheter is safe and effective in     treating malignant pleural effusions.   "
80845|NCT02227719|"     A single center, randomized, controlled, parallel-arm study is planned to investigate     clinical outcomes of horizontal ridge augmentation with simultaneous single implant     placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the     inclusion criteria will be enrolled. They will be randomly placed into one of two treatment     groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a     control. The decision of which material to use will be made after an implant is placed.     Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after     which the implants will be surgically uncovered and restored. Outcome analyses will be     performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from     the implant surgery. Clinical and radiographic parameters will be compared between the two     experimental groups. The primary outcome is linear increase of horizontal ridge width from     direct measurements.   "
80846|NCT02227706|"     To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to     achieve haemostasis during surgery in paediatric patients.   "
80847|NCT02227693|"     This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using     avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver     disease. This study will assess the effect of avatrombopag on platelet counts in Japanese     subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count     measured at Screening and Baseline. Within the lower baseline platelet count cohort (less     than 40 x 10^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg     avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher     baseline platelet count cohort (from 40 to less than 50 x 10^9/L), subjects will be     randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for     5 days.   "
80848|NCT02227680|"     This project studies the feasibility of (1) implementing massage therapy and music therapy     onto a busy medical inpatient unit at Boston Medical Center, and (2) evaluating massage     therapy and music therapy's impact on patient satisfaction, patient outcomes, and cost. The     investigators will conduct a randomized controlled trial comparing massage therapy, music     therapy, and usual care to collect preliminary data on critical outcomes for patients     (satisfaction, symptom control) and for the hospital (pain medication use and length of stay,     both critical drivers of cost). The investigators anticipate using these preliminary data to     apply for a future larger and longer adequately powered randomized controlled trial to     definitively answer the following research questions: does implementation of an inpatient     massage therapy and/or music therapy service (a) improve patient satisfaction; (b) reduce     symptoms such as pain; and (c) lower health care costs through less pain medication and     reduced length of stay?   "
80849|NCT02227667|"     The purpose of this study is to find out what effects, good and/or bad, MEDI4736 has on the     patient and cancer.      MEDI4736 is a type of medication called an antibody. Antibodies are normal proteins in the     body that help fight infections and possibly cancer. MEDI4736 is a special type of an     antibody produced in a laboratory. MEDI4736 works by blocking a specific protein called the     Programmed Death Ligand-1 (PDL-1), located on tumor cells.   "
80850|NCT02227654|"     The present investigation will prospectively evaluate whether serial transvaginal     ultrasonography with Morphology Index (MI) can further reduce false positive results by more     accurately distinguishing benign from malignant ovarian tumors. If there is no change in the     detection of true positive cases, the result will be an increase in the positive predictive     value of ovarian cancer screening.   "
80852|NCT02227628|"     A human clinical consumption trial will be performed in volunteers with increased risk     factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes     and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4,     8, and 12 weeks and a 24 hr urine collection on each blood draw day.   "
80853|NCT02227615|"     The objective of this research is to characterize the urinary metabolites produced after the     consumption of mango pulp in an effort to begin to characterize the bioavailability of the     major group of polyphenolics in mango, ester-linked gallic acids, and to provide new insight     into their in vivo physiological behavior.   "
80874|NCT02227342|"     Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for     IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent     immune response to FMT thereby maintaining sustained clinical improvement and remission.     Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility     study to determine if serial FMTs can sustain a clinical response and maintain stability of     transplanted microbiota.   "
80854|NCT02227602|"     Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been     demonstrated in animals and humans. However, the efficacy of mangoes has not previously been     compared with respect to mild inflammatory bowel disease. In order to justify future     pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to     determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step.     Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant     treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with     common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the     drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as     helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the     addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would     have a significant impact on public health.   "
80855|NCT02227589|"     The investigators will recruit adolescents with alcohol or cannabis abuse and clinically     significant depression. All participants will receive 12 sessions of an evidence-based     treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12,     over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to     receive treatment augmentation with either an integrated cognitive behavior therapy for     depression, delivered by their study therapist, or depression treatment-as-usual in the     community. The study hypothesis is that integrated depression treatment will surpass     community treatment-as-usual in efficacy.   "
80856|NCT02227576|"     Chemotherapy used in the treatment of primitive tumors of the central nervous system has a     particularly important platelet toxicity compared to chemotherapy used for treatment of other     tumors. Chemotherapy postponed for toxicity is often due to thrombocytopenia (TP). The TP     and/or the other anomalies of coagulation, which can be spontaneous (Rogers, 2004) or induced     (Gerber, 2006) can have dramatic consequences:        -  specifically neurological (intratumoral bleeding with particularly important          neovascularization) with a functional aggravation and sometimes involvement of vital          prognosis,        -  digestive (Garcia-Rodiguez, 2001) in patients receiving long term treatment with          corticoids (potential gastric toxicity).      The encouraging results from the EORTC/NCIC trial by Stupp (median survival among patients     with newly diagnosed glioblastoma is 14.6 months with an estimated 5-year survival of 9, 8%),     has changed the standard of care of these patients (Stupp et al., 2009). Patients with newly     diagnosed, histologically confirmed glioblastoma receive radiotherapy (2 Gy given 5 days per     week for 6 weeks, for a total of 60 Gy) plus continuous daily Temozolomide (75 mg per square     meter of body-surface area per day, 7 days per week from the first to the last day of     radiotherapy), followed by six cycles of adjuvant Temozolomide (TMZ) (150 to 200 mg per     square meter for 5 days during each 28-day cycle). The Stupp regimen is currently the     treatment of reference for glioblastoma and is used as a basis in various clinical studies     with new agents.      This study aims to evaluate Romiplostim for the treatment of TP secondary to initial TMZ     chemotherapy of glioblastomas.   "
80857|NCT02227563|"     The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on     auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the     left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral     prefrontal cortex.   "
81273|NCT02222142|"     Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to     intermittent regional ischemic episode. The investigators retrospectively evaluated the     cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients     undergoing OPCAB.   "
80858|NCT02227550|"     Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor     apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing     catheter ablation of non-valvular AF in the prevention of peri-procedural complications.      The AXAFA trial will compare peri-ablational treatment with apixaban to peri-ablational     treatment wit VKA in a randomized trial of patients undergoing catheter ablation of atrial     fibrillation (AF).   "
80859|NCT02227537|"     A multicenter, prospective, non-randomized, single-arm observational study evaluating the     Providence nighttime bracing system in patients diagnosed with adolescence idiopathic     scoliosis.   "
80860|NCT02227524|"     In this study, the investigators will examine a sample of persons with multiple sclerosis     (MS) to determine whether their walking function and ability is different depending on which     walking assistive device is used.   "
80861|NCT02227511|"     Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between     regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic     rate, liver steatosis and physical activity are investigated ahead of start of the study and     at the end of the trial period och two months. Participants will be allowed to buy fruits or     nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed     for the costs of the snacks.   "
80862|NCT02227498|"     The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with     severe age-related macular degeneration (AMD). The Argus II System has already been studied     in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of     the retina are irrevocably damaged and the Argus II System has been found to restore some     basic visual function. On these grounds, the device has received authorization for use on the     European market (the CE certification) in 2011.      In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with     the Argus II System. The study will evaluate the safety of the device and surgery, as well as     functioning of the system and the extent of any restored vision. Each subject will be     followed for 3 years, with their eye health and visual function tested at multiple time     points.   "
80863|NCT02227485|"     This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian     traditional mouth rinse (Punica granatum Pleniflora or Golnaar mouthrinse) on treatment of     diabetic gingivitis and compare it with chlorhexidine (0.2%).   "
80872|NCT02227368|"     To compare the effect of ticagrelor versus aspirin on the change in peak walking time,     evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in     patients with peripheral artery disease who have undergone endovascular revascularization for     moderate to severe claudication or ischemic rest pain.   "
80873|NCT02227355|"     This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy     for younger and older patients with Parkinson's Disease under real life conditions. Effects     on ability to perform activities of daily living, sleep, medication dose and other factors     will be assessed.   "
80864|NCT02227472|"     Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of     the impact the disease can have on the central nervous system. Specific impairments in     working memory are particularly prevalent in school-aged children with SCD. Working memory is     more strongly associated with school readiness and academic success than intellectual ability     in the general population. The adverse effects of low socioeconomic status (SES) and poverty     on cognition and neurodevelopment emerge early, before children have entered formal     education. In addition, they affect language and executive function skills (e.g., working     memory) more than other skills. SES is a proxy variable for other risk factors. Higher SES is     associated with less parental stress, more supportive parenting practices, and better     cognitive stimulation based on the availability of books, computers, and outings.      PRIMARY OBJECTIVE:        -  To examine working memory and school readiness in young children with sickle cell          disease in comparison to demographically matched control children without sickle cell          disease.      SECONDARY OBJECTIVE:        -  To examine the relationships of family/environmental factors (caregiver stress, parental          responsiveness, and cognitive stimulation in the home) and disease severity to working          memory and school readiness skills in preschool-aged children with SCD.   "
80865|NCT02227459|"     The purpose of this study is to evaluate the safety and tolerability of multiple doses of     ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis.   "
80866|NCT02227446|"     The Vancomycin Study is a multi-center, prospective randomized controlled trial that will     compare the proportion of deep surgical site infections within 6 months in patients treated     with local Vancomycin powder compared to those treated without local Vancomycin powder at the     time of fracture fixation.   "
80867|NCT02227433|"     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and     safety of BV as a single agent in elderly patients at first relapse or with primary     refractory HL.      BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of     anti-cancer activity will be assessed using the revised response criteria for malignant     lymphoma (Cheson et al. 2007).      Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at     baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be     done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT)     assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up     assessments (including survival and disease status information) will be performed every 12     weeks until either patient death or study closure, whichever occurs first. Patients who     discontinue study treatment with stable disease or better will have CT scans done every 12     weeks until disease progression.      Study Objectives      Primary:      • To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg     administered intravenously every 3 weeks) as measured by the overall objective response rate     in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).      Secondary:        -  To assess duration of tumor control, including duration of response and progression-free          survival        -  To assess survival        -  To assess the safety and tolerability of BV      Additional:      • To assess disease-related symptoms Study Population Eligible patients are those with first     relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed     CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5     cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate     hematologic, kidney, and liver function. Eligible patients must not previously have been     treated with BV, patients must not have congestive heart failure, known cerebral/meningeal     disease, or any active viral, bacterial, or fungal infection requiring treatment with     antimicrobial therapy within 2 weeks prior to first study dose.   "
80906|NCT02226926|"     Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with     healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin     Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein     (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma     levels   "
80868|NCT02227420|"     In obese individuals cortisol production and secretion is increased but the underlying     mechanism is not known. Obesity leads to a pathological activation of the innate immune     system partly driven by tissue production of IL-1β. Furthermore, IL-1β is also known to     stimulate the release of adrenocorticotropin hormone (ACTH). Therefore, the investigators     hypothesise that in obese individuals tissue inflammation stimulates ACTH via IL-1β, thereby     explaining the observed hypercortisolism.   "
80869|NCT02227407|"     Ambulation would bring many physiological and psychological benefits and getting up and     walking has been a dream for paraplegia patients.The reciprocating gait orthoses (RGOs) for     paraplegics particularly draws research attentions because it mimics human gait pattern.But,     the high energy consumption and low walking speeds caused the frequent abandonment or the low     utilization of the reciprocating gait orthoses.To improve the design reducing the energy     expenditure, it requires biomechanical analysis of the pathological gait such that the gait     deviations and energy consuming mechanisms can be identified and remedial means can be     implemented.      The investigators hypotheses will include that there would exist an energy saving mechanism     of human reciprocating locomotion based on the principle of conservation of mechanical     energy.Secondly, kinematic and kinetic gait determinants could be derived from the energy     saving mechanism. Finally, the control of knee joint coordinating with the hip joint     movements would facilitate the gait progression and further reduce the energy consumption.      The objective of this clinical trial is to evaluate the gait of paraplegic patients with     reciprocating gait orthoses and to support the investigators research in biomechanical     analysis, design and control of reciprocating gait orthoses for paraplegia patients. An     experiment to study the pathological gait of paraplegia patients with an existing     reciprocating gait orthosis will be carried out.   "
80870|NCT02227394|"     This study will be conducted as a randomized, double blind, double dummy two-period crossover     study in stable asthma patients treated in accordance with the Global Initiative for Asthma     (GINA) guidelines, will be included.      The primary objective of this study is to evaluate the effect of the products under     investigation on Functional respiratory imaging parameters and evaluate the particle     deposition with Computational fluid dynamics (CFD).The secondary objectives of this study are     to assess the effect of Z7200 and Symbicort® on lung function (spirometry and body     plethysmography), on exercise capacity (6MWT)and on dyspnea (Borg CR10 Scale and VAS     dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated     through monitoring of adverse events throughout the study.   "
80871|NCT02227381|"     Learning disability affects 3% of the population. Severe types of learning disability are     more likely to have an underlying genetic cause but diagnosis is difficult because many     different genetic abnormalities may be involved. Obtaining a diagnosis is important so that     patients can be managed appropriately and their families can be given accurate information.      We aim to use new types of genetic testing which will make it possible to screen for several     different genetic abnormalities which cause learning disability at the same time, so     improving the accuracy and speed of diagnosis in the group of patients with severe learning     disability. We will focus particularly on patients where seizures and behavioural problems     are also present.This will enable more patients to be diagnosed accurately, reduce the number     of hospital appointments needed and ultimately be more cost- effective.   "
80875|NCT02227329|"     This study is being implemented to identify the role of prophylactic use of ethanol lock in     adult patients on home parenteral nutrition (HPN). Central catheter related blood stream     infection is a major complication in patients on HPN. The investigators hypothesize that the     prophylactic use of ELT will decrease the number of catheter related blood stream infections     compared to the control group. The investigators further hypothesize that with the     introduction of prophylactic ELT, the number of infections will decrease. This will improve     the quality of life (assessed using Questionnaire) in HPN patients.   "
80876|NCT02227316|"     The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy     menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.     Post UFE procedural pain and nausea are expected events. These symptoms are treated with     current standard of care medications, including opiates.      Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers     include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV     ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled     analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure     nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea     medications such as ondansetron and prochlorperazine.      This study is being conducted to compare two new medications for pain, IV ibuprofen and IV     acetaminophen, administered for 24 hours following UFE. The primary safety objective of     non-inferiority will be met and the primary efficacy objective of superiority, decreased pain     and nausea, will be accessed when compared to current standard of care regimens.      This is a 4 arm, double blind, randomized, controlled study. All patients will receive     standard of care baseline pain medications, including IV midazolam, fentanyl and     hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure.     The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV     placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These     medications will be given during the procedure and extended over a 24 hour stay.      Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will     include IV push (IVP) ketorolac, which would be given at the end of the procedure and be     continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control     every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at     intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.   "
80877|NCT02227303|"     The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient     Cloud (a mobile application for capturing data directly from subjects, enabling entry of     diary and quality of life data into internet-enabled devices) in combination with an activity     tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.   "
80878|NCT02227290|"     The study is being done to see how well the study cream works when applied once a day to     affected area of child (where they have ringworm). The results will be compared to those seen     with a placebo cream which has no active ingredient. Safety of the cream will also be     measured.   "
80879|NCT02227277|"     The purpose of this study is to determine if treatment with pegylated interferon alpha 2b     (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and     tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART).      A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant     in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV     eradication.      By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate     measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment     should be considered as a component of future viral eradication strategies.   "
89621|NCT02113033|"     The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for     the treatment of congestive heart failure with reduced ejection fraction, and to report     secondary measures of efficacy.   "
80880|NCT02227264|"     Patients with primary hyperparathyroidism (pHPT) often present with fatigue, psychological     and cognitive symptoms. Improvement in these symptoms after parathyroid adenomectomy (PTX)     has been reported. But physicians lack a method to attribute the symptoms to pHPT and to     predict the reversibility after PTX.      This study aims to evaluate short-term calcimimetic treatment as a tool for predicting the     outcome of PTX on muscle strength, quality of life, psychological symptoms, and cognitive     function in patients with pHPT.      Material and Methods: 118 patients scheduled for PTX at Karolinska University Hospital,     Sweden, will have a four week treatment with calcimimetics (Mimpara®) before undergoing     surgery. Biochemicals, muscle strength, quality of life, psychological symptoms and cognitive     function will be analysed at baseline, after four week follow-up and postoperatively.      Hypothesis: The outcome of short-term calcimimetic treatment can predict the outcome of PTX     on muscle strength, quality of life, psychological symptoms, and cognitive function in     patients with pHPT   "
80881|NCT02227251|"     A multicenter, open-label Phase 2b study of selinexor (KPT-330) in patients with     relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit.   "
80882|NCT02227238|"     For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend     to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse     transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors     (NRTIs) for first-line antiretroviral therapy (ART); however, there is a need for further     data on the best treatment options for people with HIV-1 who have virological failure with     this first-line regimen. The number of patients failing on their first-line regimen is     increasing thereby requiring a switch to second-line treatment to reduce accumulation of     drug-resistance mutations, disease progression, HIV transmission, and death. WHO guidelines     recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a     ritonavir-boosted protease inhibitor (PI); atazanavir (ATV) plus ritonavir (RTV) or lopinavir     (LPV)/RTV are the preferred boosted PI options. This study is conducted to demonstrate     non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen     compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV +     two NRTIs, in HIV-1 infected patients failing first line therapy. This study comprises of a     Screening Phase (approximately 28 to 42 days), a Randomized Phase (Day 1 to Week 48 plus a     4-week treatment extension), and a Continuation Phase. Approximately 612 subjects will be     randomized 1:1 to receive DTG 50 milligram (mg) once daily or LPV/RTV (800/200 mg once daily     or 400/100 mg twice daily, in accordance with investigator decision and local label), each     added to an investigator selected background regimen of two NRTIs at least one of which needs     to be fully active based on viral resistance testing at Screening. Subjects randomized to     receive DTG who successfully complete 52 weeks of treatment will continue to have access to     DTG until it is either locally approved and commercial supplies are available to patients or     the patient no longer derives clinical benefit, or the patient meets a protocol-defined     reason for discontinuation.   "
80883|NCT02227225|"     Postoperative delirium has been found to be associated with increased risk of future     neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has     been found to be associated with an increased risk of postoperative complication including     delirium in the elderly.The purpose of this study is determine the factors affecting the     incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the     Singapore population.   "
80884|NCT02227212|"     Primary Objective:      To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2     diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.      Secondary Objectives:      To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and     insulin-naïve T2DM patients.      The safety and usability of the U300 pen injector. The glycemic control with the U300 pen     injector. The safety of HOE901-U300.   "
80885|NCT02227199|"     This phase I/II trial studies the side effects and best dose of brentuximab vedotin that can     be combined with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin     lymphoma that has come back (relapsed) or is not responding to treatment (refractory).     Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in     different ways by targeting certain cells. Drugs used in chemotherapy, such as ifosfamide,     carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving brentuximab vedotin together with an ifosfamide, carboplatin, and etoposide     chemotherapy regimen may kill more cancer cells.   "
80886|NCT02227186|"     Children in schools in which influenza vaccination clinics are held during school hours will     have higher rates of influenza vaccination than children in control schools (no     school-located clinics offered)   "
80887|NCT02227173|"     This is an open-label, single-sequence, drug-drug interaction study in healthy male and     female subjects. There is no formal research hypothesis to be statistically tested. It is     expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may     increase the exposure of montelukast, flurbiprofen, and digoxin.   "
80888|NCT02227160|"     The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial     with low-income African American suicide attempters. Guided by the Theory of Triadic     Influence (TTI), this pilot randomized controlled trial aims:        1. to determine if psychosocial group intervention (PGI) is more effective than enhanced          treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary          outcome) and improving its correlates (depressive symptoms, hopelessness, quality of          life) (secondary outcomes) in low-income African Americans with a recent attempt.        2. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I),          social/situational (SS), and cultural/environmental (CE) risk and protective factors          that mediate the condition-suicidal behavior and correlates link and thus serve as          mechanisms of change.        3. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link          and thus serve as predictors of intervention outcome.      Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence     greater improvements in suicidal behavior and its correlates than those in ETAU.      Hypothesis for Aim 2: Changes in these risk and protective factors will account for condition     effects on outcomes: (1) psychological distress, aggression, impulsivity, substance abuse,     low self-esteem, and suicide acceptability (I-risk); (2) perceived burdensomeness and     thwarted belongingness, relationship discord, intimate partner violence perpetration and     victimization (SS-risk); (3) access to a weapon and barriers to service utilization     (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective coping, and     spiritual well-being (I-protective); (5) overall family health and social support from family     and friends (SS-protective); and (6) religious involvement and effectiveness of obtaining     resources (CE-protective).      Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of     Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward the     self and others (I); (2) children and more limited trauma histories (SS); and (3) more daily     hassles and less exposure to community disorder (CE) will evidence greater reductions in     suicidal behavior and its correlates and greater enhancements in quality of life at     post-intervention and follow-up.   "
80907|NCT02226913|"     Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control.     The purpose of this prospective, randomized, double-blind study was to evaluate the effect of     adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on     the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic     irreversible pulpitis.   "
80889|NCT02227147|"     The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of     rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle     (formulation containing anti-oxidant) given 6 times a day. The evaluation of efficacy is     intended as:        -  complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer)          neurotrophic keratitis (NK) as measured by the central reading center using corneal          fluorescein staining,        -  assessing the duration of complete healing,        -  improvement in visual acuity and improvement in corneal sensitivity.   "
80890|NCT02227134|"     This is a prospective study to see whether ultrasonography can predict difficult airway     and/or predict obstructive sleep apnea syndrome (OSAS) in children.   "
80891|NCT02227121|"     The proposed study is designed to characterize defibrillation efficacy in humans for the     potential development of a new extravascular implantable cardioverter defibrillator (ICD)     system.   "
80892|NCT02227108|"     The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in     pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)     or B-cell lymphoblastic lymphoma.   "
80893|NCT02227095|"     This research focuses on overweight, sedentary children whose health, cognition, and academic     performance are therefore at risk, and who may be particularly responsive to exercise     interventions.      This study will determine whether regular exercise per se (i.e. compared to attention     control, or placebo, condition) benefits children's cognition and achievement, and will     provide insight into neural mechanisms. A substudy will examine exercise-induced changes in     brain structure.      Provision of comprehensive evidence for the benefits of exercise on children's health may     reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by     persuading policymakers, schools and communities that time spent in physical activity     enhances, rather than detracts from, learning.   "
80894|NCT02227082|"     The majority of breast cancer patients receive radiotherapy as part of their treatment.     Radiotherapy improves both locoregional control and overall survival. In most patients with     breast cancer the locoregional recurrence rate (LRR) is low, however still high LRRs are     found in certain patient groups, especially in locally advanced, inflammatory and triple     negative breast cancer. Olaparib is a potent PARP inhibitor developed as an anti-cancer drug     for homologous recombination (HR) defected tumors and as a dose intensifier for chemo- and     radiotherapy. The combination of olaparib and radiotherapy is expected to improve     locoregional control and thereby overall survival in both breast cancer patients with a high     probability of locoregional recurrence and patients with HR deficient tumors. However, this     combination treatment has never been tested in humans before. The purpose of this study is to     determine the safety and tolerability of radiotherapy to the breast and regional lymph nodes     with concurrent olaparib.   "
80895|NCT02227069|"     This is a single center, randomized, controlled, within-subject comparison, multiple dose     study to determine the irritation potential of M518101 on normal skin under occlusive patch     condition.      The study drug will be applied for 21 days under occlusive patch condition. The irritation     potential of M518101 will be compared with positive, negative control and M518101 vehicle.     The study duration is 21days and there will be at least 23 visits to study center including     screening visit.   "
80896|NCT02227056|"     The purpose of this study is to investigate the influence of Methylphenidate in pediatric     acquired brain injury population, regarding ecologic (every day) function. It is hypothesized     that the function with treatment will improve when compared to function without treatment in     the same patient. Improvement is expected by shortening time of execution in each specific     task and by reduction of the amount of assistance needed.   "
80900|NCT02227004|"     Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to     safety concerns. Recent work in our laboratory as well as our pilot study of approximately     500 patients has shown the safety of most contemporary implanted rhythm management devices in     the MRI environment given appropriate precautions. Because the investigators have completed     testing in animals weighing as little as 80 lbs. without incident, the investigators feel     they can safely image children at this weight or greater (Circulation 2004; 110:475-482).      The goal of this study is to expand on our pilot study and to develop a protocol, consistent     with the Department of Health and Human Services (DHHS) requirements, that will increase our     safety experience with clinically indicated MR imaging in patients with implanted cardiac     pacemakers and ICD's.      This is a cohort study. One thousand seven hundred patients with a clinical need for MRI will     be recruited. Risks and Benefits associated with Magnetic Resonance (MR) imaging in the     setting of implantable devices will be discussed and informed consent obtained. The type of     device and leads will be ascertained. Patients will be monitored by a physician or a     Registered Nurse (RN) with ACLS certification and familiarity with ICD/Pacemaker programming     during the study. When imaging children who meet age and weight criteria, a physician will be     present during the entire study. Fellow and attending radiology and electrophysiology support     will be available in house in all cases.      Standard device testing including battery voltages, thresholds, sensing and lead impedances     will be measured.   "
80901|NCT02226991|"     Study to investigate the effects of steady-state Efavirenz (600 mg QD) on the steady-state     pharmacokinetics of Tipranavir (500 mg BID) coadministered with Ritonavir (200 mg BID)   "
80902|NCT02226978|"     Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a     prodrug of aciclovir (ACV)   "
80903|NCT02226965|"     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a     multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize     anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r)     diffuse large B-cell lymphoma.   "
80904|NCT02226952|"     Study to assess the antiviral efficacy, pharmacokinetics and tolerability of BILN 2061 ZW in     a polyethyleneglycol 400 (PEG 400: ethanol) drinking solution given for two days bid in     patients with chronic Hepatitis C Virus (HCV) infection.   "
80905|NCT02226939|"     Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN     2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for     two days bid to patients with cirrhosis and chronic Hepatitis C Virus (HCV) infection   "
89622|NCT02113020|"     The objective of this clinical trial is to examine the clinical pharmacology properties of     TAK-233 in healthy female subjects   "
80909|NCT02226887|"     Design Prospective , randomized, parallel phase IV.      Objectives Main objective        -  Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of          incisional hernia of the abdominal wall at the site of a loop ileostomy when it is          closed  to rebuild the intestinal transit. The effectiveness evaluation is done by          tracking with scheduled patient visits for 12 months, assessing the physical examination          the presence or absence of an incisional hernia and an abdominal tomography at the end          of the 12 months .      Secondary objectives Comparison of complications(morbidity and mortality) to assess safety     and tolerability of the placement of the mesh described .   "
80910|NCT02226874|"     Background:      - The National Cancer Institute was funded to study how much radiation U.S. veterans who     served in the 1950s were exposed to. Researchers want to estimate how much radiation these     veterans received. They will use two methods and compare them. One is to interview the     veterans and study their military records. The other is to take blood samples and look for     certain types of changes in the blood cells. Being exposed to some kinds of radiation is     known to cause changes in blood cells. The amount of changes to these cells tells scientists     about how much radiation was received.      Objectives:      - To better understand how to measure how much radiation a person has received.      Eligibility:        -  Veterans who were exposed to radiation at a specific site in the Pacific in 1954 or          other sites in the 1950s.        -  Veterans close in age to the first group, who have low levels of exposure to radiation.        -  Men about 25 years old with no exposure to radiation.      Design:        -  Participants will have 1 visit, in their home.        -  All participants will have blood drawn. This will take 10 minutes.        -  The exposed veterans will be interviewed. They will answer questions about the nuclear          events they experienced. This will take up to 40 minutes.        -  For the exposed veterans, researchers will look at their military records, if they can.          They will estimate how much radiation the veteran received.   "
80921|NCT02226731|"     The purpose of this study is to evaluate the impact of early intrauterine tamponade with a     Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal     delivery and refractory to first-line uterotonic treatment, ie performed at the same time as     second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case     of failure of second line uterotonic treatment, on the final severity of PPH. ).   "
80935|NCT02226549|"     This study is to evaluate the antiviral efficacy, safety, and tolerability of combination     therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV)     ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1     hepatitis C virus (HCV) infection and cirrhosis.   "
80911|NCT02226861|"     Background:      - Stem cell transplantation from a partially matched donor can lead to graft-versus-host     disease (GVHD). Researchers want to learn how to improve these transplantations.      Objective:      - To see if very low doses of Interleukin-2 after a partially matched transplantation prevent     GVHD.      Eligibility:        -  Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an          available family member with partial tissue match.        -  Donors: age 18 80.      Design:        -  Recipients will be screened with medical history, physical exam, and many tests          including blood and tissue tying.        -  Donors will be screened with medical history, physical exam, blood tests and tissue          typing.        -  Recipients will stay in the hospital 3 6 weeks.        -  All participants will have apheresis. Blood is drawn from one arm, run through a machine          that collects white blood cells, then returned into the other arm.        -  Recipients will have:        -  Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout          transplant and recovery. They may also have a catheter inserted for collecting immune          cells.        -  Bone marrow sample taken by needle. They will have 3 more after transplant.        -  Donors will have:        -  Filgrastim injected once daily for 5 6 days.        -  Stem and immune cells collected by another apheresis.        -  Recipients will get:        -  Eight 30-minute doses of radiation, sitting at a machine.        -  Donor immune cells by IV, 6 days before the transplant day.        -  Chemotherapy drugs by IV.      <TAB><TAB>- Donor stem cells by IV on transplant day.        -  After transplant, recipients will give self-injections of very low doses of          Interleukin-2 once daily for about 12 weeks.        -  Before and after transplant, recipients will get medicine to suppress the immune system          and antibiotics to prevent infections        -  Recipients must stay near NIH for 3 6 months after transplant.        -  All recipients and donors will have 3 years of follow-up.   "
80912|NCT02226848|"     Background:      - Traumatic brain injury (TBI) injures blood vessels in the brain. Endothelial progenitor     cells (EPCs) help the body form new blood vessels. The drug erythropoietin (EPO) helps the     body make more blood cells and might help make blood vessels. Researchers want to see if EPO     helps people with TBI.      Objective:      - To see whether erythropoietin increases the number of endothelial progenitor cells     circulating in the blood and changes reactivity of brain vessels.      Eligibility:      - Adults age 18 70 who had a TBI 3 7 days ago and still have symptoms.      Design:        -  Participants will be screened with medical history and blood tests. Vital signs will be          taken.        -  Visit 1:        -  Medical history, physical exam, and blood sample.        -  Neuropsychological tests of memory, attention, and thinking. These include written and          spoken questions, tests on paper or computer, and simple actions.        -  Magnetic resonance imaging (MRI) scan with carbon dioxide. Participants will lie on a          table that slides in and out of a metal cylinder. For part of the scan, participants          will wear a breathing mask like a snorkel and wear a nose clip.        -  Study drug or placebo injection under the skin of the arm, leg, or buttock.        -  Visits 2, 3, and 4 will be 1 week apart.        -  Blood sample.        -  Review of TBI symptoms and any drug side effects.        -  Study drug or placebo injection under the skin.        -  Visit 5 will be 1 week after visit 4. Visit 6 will be 6 months after participants start          the study.        -  Blood sample.        -  Review of TBI symptoms and any drug side effects.        -  Neuropsychological tests.        -  MRI with carbon dioxide.   "
80927|NCT02226653|"     The purpose of this study is to determine if two different dosing strategies for evacetrapib     will have essentially the same effect on the body. The study will also explore the effect of     a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks,     not including screening. Screening is required within 28 days prior to the date of first     dosing.   "
80928|NCT02226640|"     This is a study to identify different subtypes of type 2 diabetes. The investigators will     look for information at the molecular level, which may lead to personalized diagnosis and     therapies.   "
80972|NCT02226068|"     Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring     systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but     potential side effects are concerning. Several reports point at extracorporeal photopheresis     (ECP) as an efficient alternative treatment modality with few and mild side effects. However,     no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In     this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.   "
80913|NCT02226835|"     Background:      - Alzheimer s disease affects the brain and causes memory and thinking problems in older     people. Macular degeneration (MD) is an eye condition. It is the leading reason that people     over age 55 in the United States lose their central vision. Central vision is important for     seeing fine details and for tasks like reading and driving. A feature of Alzheimer s disease     is plaques in the brain. A feature of age-related MD is deposits in the retina in the eye.     Researchers want to learn more about these diseases and find out if they are related.      Objective:      - To see whether there is a relationship between Alzheimer s disease and age-related macular     degeneration.      Eligibility:      - People with or without Alzheimer s disease enrolled in another study. Participants must     have someone to help them take part in this study.      Design:        -  Participants will be screened through the other study. They will have 1 visit. The tests          will take about 3 hours.        -  Participants will answer questions about their medical and eye history.        -  Participants will have an eye exam to test how well they see. Their eye pressure will be          measured and their eye movements will be checked.        -  Participants will get eye drops to dilate their pupils. Researchers will take pictures          of the retina and the inside of the eye. Researchers may measure the thickness of the          retina.        -  Participants will continue to receive care from their regular eye doctor during and          after the study.   "
80914|NCT02226822|"     This study is intended to prospectively research the treatment reality and long-term disease     control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes     treatment in sites across Japan.   "
80915|NCT02226809|"     Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is     a source of complications, mainly respiratory. The incidence is variable due to multiple     factors. In Spain the incidence is unknown.      The investigators hypothesize that a number of patients in the postanesthesia care unit     (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular     block agents (NMBA).      The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary     objectives are to observe the possible relationship with other pre- and intraoperative     factors.   "
80916|NCT02226796|"     We hypothesize patients who have difficulty with word recall (naming pictures) due to a     stroke will experience greater benefit in word recall after receiving a combination of     transcranial direct current stimulation (tDCS) and traditional behavioral treatment. This     study will investigate the effects of the timing of tDCS in relationship to the behavioral     treatment to determine the most optimal protocol. Transcranial direct current stimulation     involves placing two electrodes on your scalp and sending a very small electrical current to     excite the brain cells of the target site.   "
80917|NCT02226783|"     Study to evaluate the effect of intake of food in comparison to fasting condition on     pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet     formulation   "
80918|NCT02226770|"     The aim of the present study is to measure heart-focused anxiety, general anxiety,     depression, PTSD and quality of life as well as type D personality in patients with heart     failure before and after the implantation of a cardioverter defibrillator (ICD) and/or assist     device (AD).   "
80919|NCT02226757|"     This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on     standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2     expression, patients can participate in the trial after obtaining informed consent.      Patients will be treated with weekly paclitaxel-trastuzumab.   "
80920|NCT02226744|"     Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow     breathing techniques to induce physiological and mental relaxation. Medical research suggests     that slow breathing techniques induce physiological relaxation. This 6 week study will     compare the effects of different types of breathing. The hypothesis is that different     breathing techniques produce different physiological and mental changes.   "
80922|NCT02226718|"     For measuring quality of life in patients with chronic inflammation of the middle ear, only     two questionnaires currently exist. However, these questionnaires are designed only to     measure either disease-specific health or hearing-related quality of life. The aim of this     project is the validation of a pre-existing comprehensive questionnaire, which is routinely     administered in the investigators clinic but has never been validated. Following a     retrospective item reduction based on existing data, this questionnaire will be prospectively     validated. Applying the resulting questionnaire in future studies on chronic middle ear     inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of     life will be assessed. Therefore, the investigators questionnaire will add substantial     information to these outcome studies by providing a subjective outcome parameter.   "
80923|NCT02226705|"     Radical endoscopic transnasal surgery associated with medical treatment with liposomal     amphotericine B may increase the local control of Rhino-Sinusal Mucormycosis and the survival     rate. The objective of this study is to evaluate the local control rate and survival rate at     3 months after radical endoscopic transnasal surgery extended towards the skull base in     association with antifungal therapy and early surgical reevaluation of the extent of the     disease.   "
80924|NCT02226692|"     The aim of the present study is to quantify the relative contribution of variables obtained     during a physical fitness evaluation and a short screening questionnaire in determining the     short-term and long term risk of persistent disabling low back pain in patients with chronic     low back pain. It has been hypothesized that patients with higher physical fitness will     present a lower risk of persistent disabling low back pain and so, a lower score on the     questionnaire.   "
80925|NCT02226679|"     The objective of this extension study is to evaluate the safety and potential beneficial     effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a     dilated cardiomyopathy. The results of this study will provide confirmatory evidence of the     long-term safety and effectiveness of the Algisyl-LVR in patients with established heart     failure.   "
80926|NCT02226666|"     The purpose of this study is to prospectively compare the physiologic response of patients     who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine     (MultiHance).   "
82163|NCT02210507|"     The goal of the research study is to determine the absorption, metabolism, and bioconversion     of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava     compared to a mixture of red palm oil and gari made from typical white cassava.   "
80929|NCT02226627|"     This study aims to make a proper scientific assessment on the dietary intake and physical     activity levels of a representative sample of the urban population of 8 Latin American     countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The     study was based on complex, multistage sample design, stratified by conglomerates, being all     regions of each country represented, and random selection of main cities within each region     according to probability proportional to size method. Sample will be stratified by gender,     age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and     divided in three strata (high, medium and low) based on national indexes used in each     country. All the study sites are university-based and will adhere to a common study protocol     for training, implementation of fieldwork, data collection and management, and quality     control procedures to be performed simultaneously. All participants will be required to     provide a written informed consent. A pilot study at small scale will be performed in each     country in order to test procedures and tools involved in ELANS. Anthropometric variables,     including body weight, height, waist, hip and neck circumferences will be measured according     to a standardized protocol. Nutritional intake evaluation will be performed using two 24-hour     dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire.     Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota     University) after a harmonization process between local foods and NDSR database. Physical     activity and energy expenditure will be assessed by IPAQ-long version questionnaire and 7-day     accelerometry.   "
80930|NCT02226614|"     This study is testing a head-cooling device on volunteers to assess temperature reduction.   "
80931|NCT02226601|"     Morphine and similar substances (called opioids) are often prescribed for moderate to severe     pain, such as after a surgery, thus allowing for minimal pain and a better recovery.     Unfortunately various, non-dangerous side effects from opioids occur often that limit the way     patients feel and can take of themselves, despite otherwise good pain control and minimal     limitations from the surgery itself.   "
80932|NCT02226588|"     The objective of this study is to compare two community-level strategies: either selective,     early administration of 800 mcg sublingual misoprostol to women for secondary prevention of     postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of     delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority     trial is its potential to inform service delivery programs on clinical outcomes, program     feasibility, cost, and acceptability of two different community models of PPH care using     misoprostol.1. The study hypothesizes that a service delivery model that administers     misoprostol for secondary prevention is non-inferior to a model that administers misoprostol     for universal prophylaxis.   "
80933|NCT02226575|"     The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress     management program targeting wellbeing in patients with atrial fibrillation and their     relatives.   "
80934|NCT02226562|"     The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate     mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice     for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard     fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner     blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity     Score of the two selected test teeth) study in participants with at least two sensitive teeth     that meet all the criteria at the Screening and Baseline visit. Participants will be assessed     at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.   "
80936|NCT02226536|"     Introduction: the global sugar consumption has increased in the past 50 years and their     abusive intake is responsible for the insulin resistance and causes the metabolic syndrome -     obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate     the effect of scheduled diet without glucose as treatment of labyrinthine disorders     associated with glucose-insulin index. Study Design: A prospective randomized controlled     trial. Patients and Methods: A study conducted at the University of São Paulo with 51     patients divided into two groups: Diet Group (DG) that comprises subjects treated with     fractionated diet with glucose restriction and control group (CG) where individuals were not     counseled regarding diet. Patients underwent computerized dynamic posturography - sensory     organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days     of the study.   "
80937|NCT02226523|"     To improve the sensitivity and specificity of immunoassay, the developing trends are to lower     the detection threshold and to minimize the cross reaction. A new assay technology called     immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with small     volume of sample. Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and     operational priority in busy emergency departments (ED), early and correct diagnosis is     important. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and     electrocardiography (ECG) in combination with the medical history and physical examination     are at present the diagnostic cornerstones. Novel biomarkers that rise earlier, have good     diagnosis accuracy and have additional prognostic information are highly needed. The     combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque     ruptures or heart failure with different mechanism) may increase clinical sensitivity and     improve early risk stratification. The present study, a rapid IMR assay with multiple     biomarkers is proposed and we will examine the performance of this new investigational IMR     assays, comparison with current commercial assays.   "
80946|NCT02226406|"     In the critically patient bed rest and immobilization are some of the responsable of the     development of respiratory complications. Early physical exercise is a tool to prevent     respiratory complications as lost of respiratory muscle strength, decrease in functional     residual capacity and hypoxemia improving oxygenation.      New technology as electrical impedance tomography (EIT) are available to visualize changes of     regional lung aeration.      The aim of this study is to assess the effect of early physical exercise improving alveolar     recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with     EIT.      The ICU patients included at day of evaluation will be evaluated continuously with EIT in     different positions. 1) in the supine position (at 30° of inclination), 2) Sitting in chair     3) Active physical exercise 4) And rest in chair after exercise   "
82164|NCT02210494|"     Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for     early adenocarcinoma of the esophagus.   "
80938|NCT02226510|"     Thickening of the heart muscle (left ventricle) known medically as Left Ventricular     Hypertrophy (LVH) is very common in patients with heart disease. This increases risk of     cerebrovascular/cardiovascular event.      LVH is asymptomatic and managed by the use of medication to control blood pressure, however     LVH may be seen in normotensive patients where factors such as obesity and insulin resistance     are present.      Insulin resistance is a condition where although the body produces insulin it is unable to     utilize it effectively. Metformin, a drug used to treat diabetes, can reduce insulin     resistance and cause weight loss, it may therefore improve LVH. This study will investigate     the ability of metformin to reduce LVH in patients with heart disease, this may be a novel     way forward in the risk reduction of cerebrovascular/cardiovascular events. Participants will     be identified throughout NHS Tayside, those eligible will be randomly allocated to either     metformin or a dummy medication (placebo) and will receive one year of treatment. At the     beginning of the study, the thickness of the heart muscle will be measured by ultrasound scan     and cardiac Magnetic Resonance Imaging (cMRI). We will also perform non-invasive tests to     measure blood vessel function. These tests will be repeated after one year. At the end of the     study, we will investigate the difference between placebo treatment and metformin treatment.      This study is funded by the British Heart Foundation.   "
80939|NCT02226497|"     This randomized pilot clinical trial studies a home telemonitoring device in managing the     care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are     discharged from the hospital following chemotherapy. After treatment and hospital discharge,     patients typically need extensive care to deal with the side effects of chemotherapy, keep up     with medications, and obtain medical assistance. A home telemonitoring device would allow     patients to monitor vital signs, symptoms, and use of medications, communicate with     healthcare providers, and access educational material. A telemonitoring device may allow     patients to be managed more effectively than standard outpatient care after being discharged     from the hospital.   "
80940|NCT02226484|"     Purpose:        1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the          esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and        2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by          improvement in the barrier function and acid resistance of the lining of the esophagus          of patients with a diagnosis of gastroesophageal reflux disease (GERD)      If interested, participants will be consented and provided a questionnaire to complete as     part of the study. Participants will undergo endoscopy for routine care and will have up to 8     esophageal biopsies (small tissue samples) taken for the research study. After endoscopy,     participants will be contacted to begin a 6 week treatment period with study drug (Quercetin,     taken twice daily).      At the end of the 6 week period, participants will be scheduled to have blood drawn and to     have a follow-up endoscopy with biopsies performed for the research study.   "
80941|NCT02226471|"     Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines     may play important roles in the pathogenesis of obesity, which are a link between obesity and     obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4     (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This     study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and     essential hypertension.   "
80942|NCT02226458|"     The investigators hypothesize that EPI-743 may provide clinical benefit to children with     Autism Spectrum Disorder.   "
80943|NCT02226445|"     The investigators knowledge of factors associated with treatment drop-out and missed     appointments among adults with Attention-Deficit/Hyperactivity Disorder (ADHD) within a     naturalistic, clinical setting is very limited. Drop-out rates among adult ADHD patients in     randomised controlled trials (RCT´s) have been reported to be 26.6% - 50%, and similar rates     are reported in two naturalistic studies of medication adherence.      Based on proposed hypotheses that past behaviour patterns are more predictive of current     behaviours of treatment drop-out and missed appointments than are sociodemographic and     clinical characteristics, the aim of the present study is to examine the associations of 1)     sociodemographic variables, 2) clinical variables, 3) risk-taking behaviour 4) educational     and occupational instability and 5) behaviours during primary/lower secondary school with     treatment drop-out and number of missed appointments.      The target group of the study consists of all patients who initiates assessment at the adult     ADHD Clinic at Regional Psychiatric Services West, Herning, Central Denmark Region in the     period from September 1, 2010 to September 1, 2011. The patients are referred to this Clinic     from general practitioners and specialised psychiatric authorities. The investigators study     is designed as an observational, cohort study in which the patients are offered medical and     non-manualised psychosocial treatment as it is usually offered in this tertiary ADHD Clinic     from which the data are collected.      Data regarding sociodemography, clinical symptoms and impairments, risk-taking behaviour,     educational and occupational instability and behaviours during primary/lower secondary school     are collected using a semistructured protocol.      In the investigators study the investigators define treatment drop-out as premature     termination of ongoing treatment, without any prior clinical or agreed resolution. No     standardized definition of treatment drop-out is used through out the literature of adherence     to treatment among patients in the psychiatric care system.   "
80945|NCT02226419|"     The investigators wish to investigate fat and sugar metabolism during exercise with and     without L-carnitine supplementation in patients with carnitine transporter deficiency (CTD).      Patients with CTD have low plasma- and muscle concentrations of carnitine, which is believed     to lead to an impaired fat oxidation. Presently there is no cure available for these     patients, but daily intake of L-carnitine has been shown to limit the amount of symptoms.     Little is known about the metabolism during exercise and the pathophysiological mechanisms     causing the symptoms.      Studying the fat and sugar metabolism in CTD patients will contribute to the understanding of     the role of the carnitine transporter in the development of symptoms in these patients.     Furthermore, knowledge about the fat and sugar metabolism in these patients can increase the     understanding of the role of the carnitine transporter in the metabolism healthy persons.      The investigators have included 8 patients with genetically verified CTD in the study and a     group of 10 age- and sex-matched controls. Subjects will perform a 1h cycling test,     exercising at a moderate intensity. By measuring the expiration of carbon dioxide (CO2) and     consumption of oxygen (O2), the investigators can determine the total fatty acid and     carbohydrate oxidation during cycling. At the same time the investigators will measure the     patients' whole body palmitate (fat) and glucose (sugar) oxidation rates using stable isotope     technique.      The patient group will repeat the cycling test after 4 days without taking their usual     L-carnitine treatment. During the treatment break, patients will be admitted to be     continuously monitored for heart rhythm disturbances, which is a known but rarely occurring     complication to untreated CTD.      Since the patients have a defect in their fat metabolism, the investigators expect to find     that they have a reduced ability to burn fat, which is the major source of energy during low     intensity exercise. It is therefore likely, that the CTD patients will benefit from     adjustments in their daily diet, whenever they have to perform physically. By learning about     the metabolism of different dietary substances, fat and sugar, these studies can help to     improve the treatment in terms of dietary recommendations for CTD patients. This will have a     direct impact on the daily life of the patients.   "
80970|NCT02226094|"     The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT     in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of     the study is to investigate the durability, repeatability, and does response of the same.   "
80971|NCT02226081|"     We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can     improve the characterization (classification) of breast lesions.   "
80947|NCT02226393|"     Traumatic events have potentially debilitating long-lasting effects on the child's normal     development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy     has been found to be effective in reducing posttraumatic stress disorder symptoms in adults     and in adolescents. It has not yet been tested in toddlers.      The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for     toddlers with PTSD and their parents. A randomized control trial could examine the efficacy     of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous     conditions would help broaden our knowledge about developmentally sensitive treatment tools     for this age group.      Our research hypotheses are:        1. PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.        2. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers'          parents.        3. These results will be preserved in a follow-up of 3-6 months post treatment. Following          psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50          participants in each group).   "
80948|NCT02226380|"     Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant     chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a     series in local advanced gastric cancer patients.      Patients and methods: The study is a prospective non-randomized study. Patients with     histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled     in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2     lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative     chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with     postoperative pathologic staging on patients who underwent radical surgery. Tumor     down-staging and the grade of pathologic response are included in a statistical correlation     between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The     primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival,     R0 resection rate, toxicity and prediction of response.   "
80949|NCT02226367|"     The purpose of the study is to evaluate if the drug prazosin:        -  will decrease alcohol use in active duty members of the military who served in Iraq          and/or Afghanistan and        -  determine if presence or absence of posttraumatic stress disorder affects treatment.   "
80950|NCT02226354|"     Seeds from the Buglossoides arvensis plant (trademarked as Ahiflower™) produce oil that is a     rich natural source (20%) of stearidonic acid (SDA), a metabolic intermediate between omega-3     fatty acids found in other plants (such as flax) and those found in fish oils.      The objectives of this study to collect safety data and to investigate the accumulation of     long chain n-3 polyunsaturated fatty acids in human lipids following oral supplementation     with Ahiflower oil in healthy adults.   "
80951|NCT02226341|"     Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the     healthy cells and tissues, causing inflammation that can damage organs in the body. About 50%     of SLE patients experience inflammation in the kidneys. The purpose of this study is to     determine the effectiveness and safety of two dosing arms of ACTHar gel in treating     proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar     are safe and effective in treating proliferative LN (Class III and IV).   "
80952|NCT02226328|"     Flexible bronchoscopy almost always requires sedation to be successful. In order to increase     the availability of propofol for sedation, non-anaesthesiologist administered propofol     sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the     general anaesthesia provided by anaesthesiologists.      Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist     administered sedation with propofol as opposed to non-anaesthesiologist administered sedation     with midazolam and fentanyl.      Propofol sedation is as safe as midazolam and fentanyl sedation.   "
80953|NCT02226315|"     This study will evaluate the clinical performance of massively parallel sequencing (MPS)     using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA     extracted from a maternal blood sample obtained from women pregnant with a multiple gestation     who were at increased risk for fetal aneuploidy.   "
80954|NCT02226302|"     The objective is to develop an organotypic model to assess the effects of obesity on the     expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental     fat samples will be removed from participants during surgery and these fat samples will be     used in laboratory analyses.   "
80955|NCT02226289|"     Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor     (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and     second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with     cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.   "
80956|NCT02226276|"     This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic     acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to     treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor     receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper     Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive     substance. Diagnostic procedures using PET may allow scanners to take pictures of where the     drug travels in the body and may help doctors identify which patients may benefit from     treatment with ado-trastuzumab emtansine.   "
80957|NCT02226263|"     The purpose of this study is to know the effects of probiotics on the incidence of     Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.   "
80958|NCT02226250|"     Primary objective is to determine absorption profile of a sugar-based beverage on     inflammatory mechanism by timing of beverage consumption relative to meal intake.      Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative     and metabolic mechanism by timing of beverage consumption relative to meal intake.      The results will be served as an internal reference or negative control group to compare with     polyphenol containing studies from other studies.      Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with     standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size     of 12 will be recruited into this part of the study.      This study is a single-arm design utilizing a multiple sampling, and repeated measures     paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute     effect on inflammatory markers.   "
80959|NCT02226237|"     The prostate cancer is the most common parenchymal neoplasia in men over 45 years old.     Radical prostatectomy is curative treatment is most used today. Urinary incontinence and     erectile dysfunction are the main complications of radical prostatectomy. Physical therapy     has been used as a form of conservative treatment of these complications. However, the role     of physiotherapy in the treatment of these complications is not well defined in the     literature. We will do a randomized controlled study with patients undergoing radical     prostatectomy. After removal of the Foley catheter, patients will be randomized into 3     groups: control group, group of pelvic floor exercises and anal electrostimulation group.     These patients will be evaluated preoperatively in an attempt to meet prognostic factors for     urinary incontinence and erectile dysfunction. They will be followed by 2 years after     surgery, to assess whether the therapy will alter the course of urinary continence and     erectile function in these patients.   "
80960|NCT02226224|"     In our era of personalized treatment, both the prognosis and the choice of therapy for upper     GI malignancies depend on the staging before any treatment. Most experts recommend EUS     (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in     clinical practice varies in different centers according to the published data. Neither the     discrepancy between EUS and histological findings nor the variation between centers well     explained. So the investigators designed this prospective study. In the present study, the     investigators performed EUS on the resected specimen after surgery before fixation in     formalin, evaluated the invasion of the GI wall, and marked the deepest location with     sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy     between EUS and histologic findings.   "
80961|NCT02226211|"     Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice.     they can be used as primary airway devices or as conduits for endoracheal intubation and they     become an integral part in the recent guidelines for managing difficult airway.      Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal     intubation.      The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage     over the competitors but not will studied as a conduit for endoracheal intubation.      This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the     air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.   "
80962|NCT02226198|"     The purpose of the study is to establish the efficacy, safety and tolerability of     rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.   "
80963|NCT02226185|"     Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,     anticancer activity of berberine hydrochloride have been explored. The aim of this study is     to investigate the effect of berberine hydrochloride on the recurrence of colorectal     adenomas.   "
80964|NCT02226172|"     A lead-in cohort of ~20 patients with primary or secondary myelofibrosis previously treated     with 1 or more Janus kinase inhibitors enrolled to single-agent glasdegib to evaluate safety     and tolerability. Following the lead-in, a phase 2, double blind, 2-arm study, randomized 2:1     to oral single-agent glasdegib versus placebo in 201 patients resistant or intolerant to     ruxolitinib.   "
80965|NCT02226159|"     Cervical radicular pain is a common cause of disability and pain in the upper extremity and     neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and     includes relative rest, use of anti-inflammatory and analgesic medication, as well as     physical therapy and home exercise. For patients who have persistent and significant     symptoms, interventional pain management and surgical management are considered. Cervical     epidural injections are the mainstay of the interventional, non-surgical modalities. They can     be considered to provide short and long-term relief when disc herniation, foraminal stenosis     or central canal stenosis pathology is identified. We are not aware of any published     prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of     cervical transforaminal epidural steroid injections. However, the North American Spine     Society (NASS) Review and Recommendation Statement states that based on the literature and     expert opinion, a minimum of one or two cervical epidural steroid injections would be very     appropriate in the treatment of a specific episode of cervical radicular pain.      The purpose of this study is to determine the effectiveness of cervical transforaminal     epidural steroid injections in decreasing the need for an operation in patients with cervical     radicular pain, otherwise considered to be operative candidates.   "
80966|NCT02226146|"     This is an open-label, proof-of-concept, single group study in adult patients with newly     diagnosed, moderate to extensive BP.      The study will consist of three periods: a screening period of up to 2 weeks, an open-label     treatment period lasting 4 weeks consisting of IV infusion of bertilimumab on Days 0 and 14     and 28, and a safety and efficacy follow-up period of approximately 13 weeks.      Patients will receive concomitant oral steroids during the treatment and follow-up period.   "
80967|NCT02226133|"     Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique     is safe and effective.   "
80968|NCT02226120|"     The purpose of this study is to collect safety and tolerability data on LCZ696 in eligible     PARADIGM-HF patients receiving open-label investigational drug.   "
80969|NCT02226107|"     Disparities among racial and ethnic minorities remain prevalent despite advances in medical     science that make thes early detection and prevention of colorectal cancer a possibility for     all human kind. It is estimated that 90% of colorectal cancer deaths could be prevented     through screening. Unfortunately, among Latinos, colorectal cancer is the second leading     cause of cancer death. This rate is influenced by the fact that Latinos have the lowest rates     of colorectal cancer screening compared to other US racial groups. Moreover, Latinos are more     likely than whites to be diagnosed with advanced-stage colorectal cancer, when treatment     options are more limited. Lay health worker interventions for breast and cervical cancer     education and screening have demonstrated success in increasing both knowledge and screening     rates among racial and ethnic minorities. Additionally, our research has also shown success     in training African Americans as peer navigators to increase colorectal cancer screening. Few     lay health interventions, however, have been designed specifically for colorectal cancer     screening among Latinos. Thus, the purpose of this study is to expand peer navigation for     colorectal cancer screening to Latinos and increase their participation in screening by     training Latinos, who have had a colonoscopy, to help navigate other Latinos through the     colonoscopy screening procedure.      This study will focus on expanding the work of our research group by training Latino peers,     who are 50 years or older, have had a colonoscopy, and can model successful colonoscopy     screening completion to navigate Latino patients for screening. First, a training manual will     be developed which will be culturally specific to Latinos. Feedback and input from community     members will guide the development of the manual and training program. Second, the training     program will be carried out with six bilingual Latino peers, who will be taught to master the     core skills of patient navigation for screening colonoscopy. Finally, we will gather     preliminary information about the trained peers' ability to successfully navigate patients     for colonoscopy screening. If successful, this training program has the potential to increase     colonoscopy screening rates of Latinos and will be critical to the development of future     large-scale in interventions aimed at reducing advanced stage diagnosis of colorectal cancer     and ultimately colorectal cancer deaths among Latinos.   "
80973|NCT02226055|"     1. We hypothesise that CKDu patients will have increased arterial stiffness and thus          increased all-cause and cardiovascular mortality. The first objective of this study is          to recruit a cohort of ~ 50 CKDu patients who attend the CKDu clinic in Anuradhapura,          and measure their arterial stiffness using the TensioMed® Arteriograph™ (details below).          We will recruit an age, sex and blood pressure matched control group of healthy Sri          Lankans (consenting visitors with patients both to clinic and as inpatients), and if          possible, a second control group, similarly age, sex and blood pressure matched, who          have CKD of known causes and attend general renal clinic in Anuradhapura.        2. We hypothesise that detailed renal analysis will give insight into the aetiology of CKDu          in the North Central Province of Sri Lanka. The second objective of the study is to          recruit up to 250 CKDu patients and to characterize their disease profile using analysis          serum and urine renal biomarkers, exosomes, proteomics and DNA adducts.   "
80974|NCT02226042|"     This research will investigate the neuropsychological mechanisms underlying the eight-week     Mindfulness-based Cognitive Therapy (MBCT) programme.      Participants in remission from depression will be seen pre- and post-MBCT to assess the     underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess     the relationship of these neuropsychological changes with relapse risk.      The research will focus primarily on changes in self-compassion, rumination, attention and     structural brain changes, with secondary focus on other mechanisms of emotional processing     and memory.   "
80975|NCT02226029|"     Quantitative MR methods will be validated for the non-invasive imaging of GI processing of     lipid emulsions in 18 (12+6) healthy subjects. Validation is performed by a randomized single     blind two-armed crossover trial with two isovolumetric and isocaloric lipid emulsions of     different microstructural properties. Hypotheses of this sudy are that        1. the fat fraction of lipid emulsions in the GI tract can be monitored by quantitative MR          methods and that 13C-sodium octanoate and        2. 13C-sodium acetate in lipid emulsions will exhibit different excretion profiles due to          their opposing binding affinity to water and fat.   "
80976|NCT02226016|"     The purpose of this study is to assess a new technique of measurement for the levator muscle.      this measurement may be applied during a clinical evaluation of eyelid malposition.      our purpose is to quantify the levator muscle strength and to corelate it to standard levator     muscle strength assessment techniques routinley used in the oculoplastic clinic.   "
80977|NCT02226003|"     This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in     combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus     (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the     study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C     (HbA1C) than placebo.   "
80978|NCT02225990|"     The purpose of this research study is to implement into clinical practice, the comprehensive     QualPro protocol for stroke survivors, which includes gait coordination, balance, mobility,     and fitness training. Feasibility will be tested in the clinical environment by providing the     intervention, measuring patient outcomes, and identifying the obstacles to insurance payment     for the QualPro intervention. By productively addressing issues of implementation, the     hypotheses of this study include proven feasibility in the clinical environment and     clinically significant gains for stroke patients in the areas of strength, balance, gait     coordination, endurance, physical function, and increased life role participation.   "
80979|NCT02225977|"     In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune     homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype     in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this     study we will determine the change in ratio of M2 (type II, alternatively activated) versus     M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that     have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess     changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by     monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine     phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1),     which is critical for the activation of M1 myeloid cells. We will assess correlates with     changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya     on myeloid lineage cells.   "
80980|NCT02225964|"     This study is to find out the imaging marker and the changing laws of the marker during the     course of the disease. The final purpose is to provide scientific evidence for new     prevention, diagnosis and treatment of Alzheimer's disease.   "
80981|NCT02225951|"     This study is initiated to investigate the effect of a nutritional product on the 3-hr     postprandial glucose response compared to a control standard breakfast at baseline and after     4 weeks of intervention.   "
80982|NCT02225938|"     Increasingly patients with critical illness requiring life support in an intensive care unit     are surviving their hospital admission. Currently the investigators do not know what effect     the ICU admission, and the life support, has on their long-term quality of life and whether     they can return to their pre-illness level of function following ICU.      The investigators aim to test telephone follow-up of ICU survivors in assessing function and     quality of life six months after ICU admission. Additionally, the investigators will identify     if there are factors that lead to poor recovery. The investigators hope this can influence     and change current ICU practice to improve recovery and long-term outcomes for patients.      The investigators aim to select a total of 300 patients from ICU, 75 patients from each of     the four ICUs. If they survive to hospital discharge, patients and their relatives will     receive a telephone questionnaire at 6 months after the ICU admission that aims to assess     their long-term outcomes, including physical, cognitive and emotional function, quality of     life, and whether they have been able to return to work following ICU.   "
80983|NCT02225925|"     The purpose of this study is to assess the performance of a system of intraoperative dynamic     dosimetry during prostate seed implantation (brachytherapy) including its new elements, to     evaluate and refine technical methods of using the system, as well as confirm its performance     and accuracy.   "
80984|NCT02225912|"     The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a     day will prevent upper respiratory infections in otherwise healthy adults working in child     day care centers.   "
80985|NCT02225899|"     With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are     enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related     diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal     health in cystic fibrosis (CF). This project is designed to investigate nutrition-related     factors, such as vitamin D status, on oxidative stress and fat oxidation which may influence     long-term survival in CF and CFRD. Based on preliminary clinical and metabolomics research     findings, the working hypotheses of this project are: 1) oxidative stress in CF contributes     to impaired fat oxidation, and 2) vitamin D supplementation normalizes oxidative stress and,     subsequently, fat oxidation. This study will combine state of the art methods with     traditional clinical methods to assess fat oxidation, oxidative stress, and nutritional     status in adults with cystic fibrosis. Research methods include blood draws for plasma     markers of oxidative stress and metabolomics (the measurement of thousands of small chemicals     in the blood), magnetic resonance imaging (MRI, to assess energy capacity and thigh fat),     dual energy X-ray absorptiometry (DEXA, to assess total and regional body fat and muscle),     and indirect calorimetry (to assess resting energy expenditure and whole body fat oxidation).     Clinically-relevant data, such as lung function, CF genotype, and diabetes status will be     obtained from the electronic medical record and the CF Registry. This study consists of two     sub-studies. The first is a cross-sectional study in 66 clinically-stable adults with CF and     44 healthy control participants. Testing in clinically-stable adults will occur in the Emory     University Hospital (EUH) Clinical Research Network (CRN) outpatient unit (blood draws,     indirect calorimetry, DEXA) and in the Emory University Biomedical Imaging Technology Center     (BITC) for MRI imaging. The second study will be an ancillary longitudinal study to the     ongoing, double-blind, placebo-controlled, randomized high-dose vitamin D trial (DISC Study,     IRB00052829, PI: Tangpricha) in patients with CF who are hospitalized for pulmonary     exacerbation. Blood draws and indirect calorimetry will be performed in patients within 72     hrs of hospital admission (before vitamin D dosing), and during 3 and 6 month outpatient     follow-up visits. The data generated from this study will be used to inform future nutrition     intervention studies in adults with CF and CFRD.   "
80986|NCT02225886|"     The administration of ascorbic acid seemed to increase the iron available for erythropoiesis,     thus improving the anemia response to the treatment.      The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid     administration in hemodialysed patients with iron overload.   "
80987|NCT02225873|"     This study will verify whether the cranio-cervical flexion coordination (motor control) and     muscle strength training protocol is more effective in improving muscle than the     proprioception and muscle strength protocol in patients with chronic neck pain.      Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol     will improve muscle function more than the proprioception and muscle strength protocol in     patients with chronic cervical pain.      Objective: To find out if applying the strength therapeutic exercise protocol and the     craniocervical flexion coordination (motor control) training is more effective than the     strength and articular repositioning protocol when carrying out the craniocervical flexion     test in patients with chronic cervical pain.   "
80988|NCT02225860|"     The purpose of this study is to learn if dietary habits can affect vasopressin secretion in     patients with autosomal dominant polycystic kidney disease. Vasopressin increases the growth     of kidney cysts and accelerates disease progression. Understanding how to control secretion     of this hormone based on dietary habits may help to develop treatments to control this     disease. The study will include about 60 patients from Tufts Medical Center. The study will     last for 2 weeks. Blood and urine tests will be done 3 times during the study period.     Subjects will be randomly assigned (by chance like flipping a coin), to one of two study     groups. Group 1 will be given instructions to adjust their diet. This will include adjusting     the amount of water, protein, and salt intake. Group 2 will have no adjustment of diet or     water. The project has tremendous public health relevance, given the large numbers of people     affected by autosomal dominant polycystic kidney disease and the substantial impact of the     disease on morbidity, mortality, hospitalizations,dialysis or transplant, and societal costs     of caring for those patients.   "
80989|NCT02225847|"     The objective of the research is to test the hypothesis that participating in group-based     gardening activities alters brain network activation and function, and that such change     occurring in the brain forms the neurobiological basis for much of the nonphysical activity     portion of the therapeutic benefits of gardening and horticultural therapy. Assessment of the     effects of the gardening activities on the experimental population will take two approaches,     the first being the use of functional Magnetic Resonance Imaging (fMRI) to assess the regions     of the brain that may become activated as a consequence of experiencing the cumulative     gardening activities and associated stimuli. The allied approach will employ widely used and     well-established self-reported assessment instruments that will capture information about the     health and well-being that will then provide a psychometrically-based before and after     physical and health summary of the participants in the control group and those engaged in the     gardening activities.   "
80990|NCT02225834|"     Recent clinical trials and meta-analyses of b-hydroxy-bmethylglutaryl coenzyme A (HMG-CoA)     reductase inhibitors (statins) have demonstrated a significant reduction in ischemic stroke     in patients with a history of coronary artery disease, both with and without elevations of     serum cholesterol. Recent data suggest that statins have other beneficial properties in     addition to the retardation of atherosclerosis. Asahi et al demonstred that Statins increased     eNOS and tPA mRNA levels but did not change mRNA levels of PAI-1 and that In eNOS knockout     mice, atorvastatin reduced the volume of ischemic tissue and improved neurologic outcomes     after arterial occlusion by blood clot emboli. In addition to their lipid-lowering effects,     it has been speculated that statins may also have beneficial effects on cerebral circulation     and brain parenchyma during ischaemic stroke and reperfusion. Aslanyan et al reported that     statin use was associated with reduced mortality at 1 month during the follow-up.      In patients with recent stroke or TIA and without known coronary heart disease, 80 mg of     atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events,     despite a small increase in the incidence of hemorrhagic stroke period .      Recently the investigators group reported that lacunar strokes compared to nonlacunar ones     exhibited significantly lower plasma levels of TNF-α and IL1-β, P-selectin and ICAM-1 24-72 h     and 7-10 days after stroke onset (4). At extracranial arterial territories, inflammation     plays a crucial role mediating all the stages of the atherosclerosis process . Similarly,     thrombosis and defective fibrinolysis may also contribute to the progression of     atherosclerotic lesions . Interestingly, both mechanisms might have a relevant role in the     pathogenesis of intracranial large artery atherosclerosis and ischemic stroke Moreover our     group showed that Patients with cardioembolic and atherothrombotic stroke subtypes showed     significantly higher median plasma levels of TNF-α, IL-6, IL-1β whereas the lacunar subtype     showed significantly lower median plasma levels of TNF-α, IL-6 and IL-1β and that     immunoinflammatory marker plasma levels are significantly related to ischemic lesion volume.      A meta-analysis showed that statins may possess antithrombotic property because these drugs     were reported to reduce periprocedural infarction in patients undergoing percutaneous     coronary intervention .      This clinical benefit was detected after median, 0.5 days of treatment with statins     (indicating that statins could potentially exert an antithrombotic effect even earlier than     supposed from pharmacological studies.      Violi et al recently showed the first evidence that atorvastatin acutely and simultaneously     decreases oxidative stress and platelet activation by directly inhibiting platelet Nox2 and     ultimately platelet isoprostanes and thromboxane A2 so providinf a rationale for the use of     statins to prevent or modulate coronary thrombosis.      Whereas recent data suggest that inflammatory reactions are involved in the pathogenesis and     progression of cerebral ischaemia , no study has evaluated effects of atorvastatin 80 mg/day     after a recent stroke on stroke outcome and on immunoinflammatory markers so to evaluate     acute antithrombotic and anti-inflammatory effects of atorvastatin also in acute     cerebrovascular event setting.      On this basis the primary objective of the study was to evaluate the separate effects of     atorvastatin in vivo on immunoinflammatory markers and on stroke prognosis in patients with     recent acute ischemic stroke classified as atherothrombotic.   "
80991|NCT02225821|"     In the Netherlands about 18,000 surgical procedures with implant removal are annually     performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg     region. For clean surgical procedures, the rate of postoperative wound infections (POWIs)     should be less than 5%. However, rates of 10-12% following implant removal, specifically     after foot, ankle and lower leg fractures are reported. Currently, surgeons decide     individually if antibiotics prophylaxis is given, since no guideline exists. This leads to     undesirable practice variation.      Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in     patients scheduled for implant removal following a foot, ankle or lower leg fracture, to     assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome     is a POWI within 30 days after implant removal. Secondary outcomes are quality of life,     functional outcome at 30 days and 6 months after implant removal and costs.      With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in     clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided     alpha=5%, including 15% lost to follow up).      If the assumption of the investigators, that prophylactic antibiotics prior to implant     removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a     strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of     care. This will reduce the incidence of POWIs and consequently will lead to less physical and     social disabilities and health care use. In addition, it will decrease the rate of use of     empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or     diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in     the Netherlands of €3.5 million per year.   "
80997|NCT02225743|"     Total joint patients have poor outcomes with infection since they are having permanent     hardware implanted. Infection prevention in this group is therefore critical and a major     source of discussion in both the orthopedic and anesthesia literature.      Hypothermia has been shown to increase the risk of infection and blood loss. However, studies     have not examined when in the operation or how fast patients temperatures drop. This study     will observe how patients' temperatures change during total joint arthroplasty. By     identifying when body temperature changes occur, prevention strategies may be developed and     implemented.   "
81274|NCT02222129|"     A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local     injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic     urologic surgeries in an effort to determine which method reduced postoperative opioid use     the most.   "
80992|NCT02225808|"     This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for anxiety     in children with high-functioning autism spectrum disorder (ASD). In addition to the core     symptoms, approximately forty percent of children with ASD exhibit clinically significant     levels of anxiety. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in     children with high-functioning ASD, but the neural mechanisms of this treatment have not been     studied. CBT teaches emotion regulation skills such as cognitive reappraisal, followed by     behavioral exposure to anxiety-provoking situations. The investigators propose to investigate     the neural mechanisms of CBT for anxiety by evaluating fMRI indices of socioemotional     functioning before and after treatment in children, ages 8 to 14, with high-functioning ASD.     Dysfunction of the amygdala and its connectivity with prefrontal cortex has been implicated     in co-occurring ASD and anxiety. In the investigators research, compared to typically     developing controls, children with ASD have shown lower activation in several regions of     prefrontal cortex and a lack of down-regulation in the amygdala during a task of emotion     regulation. Based on these observations, the investigators propose that a positive response     to CBT for anxiety in children with ASD will be associated with increased activation of     several regions in the prefrontal cortex as well as increased functional connectivity between     prefrontal regions the amygdala during the task of emotion regulation. The primary aim of     this pilot study is to examine the effects of CBT on the neural basis of anxiety in ASD by     collecting fMRI data during emotion regulation, face perception, and rest before and after     treatment. The investigators hypothesize that CBT will increase prefrontal activity, decrease     amygdala reactivity, and enhance amygdala-prefrontal functional connectivity during emotion     regulation. The investigators also hypothesize that CBT will decrease amygdala reactivity     during perception of emotional faces. Additional analyses will be conducted to explore change     in resting-state functional connectivity before and after CBT for anxiety in children with     ASD.   "
80993|NCT02225795|"     This is a study for people with Crohn's Disease (CD) that are not responsive to standard     treatment. CD is a chronic disease with an auto-immune component that goes away and relapses     over the years and causes lifelong impairment of health and quality of life. Regardless of     the therapy used some patients remain seriously ill with active disease after multiple     therapeutic options have been exhausted. There is currently no drug that will cure CD. Drug     treatment is focused on controlling symptoms. Another treatment is to perform surgery but     again this does not lead to cure and is often linked to infection, short gut syndrome     problems and psycho-social and cosmetic issues. Therefore, a treatment that does not involve     surgery or long-term drug treatment may be beneficial especially to young adults.      Hematopoietic stem cell transplantation (HSCT) has been of value in other auto-immune     diseases and it is possible that it could be of value in CD. This is a pilot study to     determine if HSCT is safe and effective for children and young adults with severe CD. For     this study the stem cells will come from the patient. This is called an autologous     transplant. The patient will undergo collection and storage of his/her peripheral blood stem     cells (PBSC). The patient will be given drugs to move (or mobilize) the stem cells from     his/her bone marrow into his/her blood where they will be collected on a machine called     apheresis (similar to dialysis.) The cells will be stored and given back to the patient about     1 month after collection.   "
80994|NCT02225782|"     Hemodialysis is a procedure that kidney physicians perform when the kidneys fail and can no     longer clean the blood and remove extra fluid and toxins from the body. Hemodialysis     therefore requires access to reach the blood through either a surgically created permanent     fistula or graft or through the insertion of a temporary catheter in one of the large body     veins. While the use of fistulas or grafts is preferred because they are permanent, there may     be conditions that prevent patients from having them and a hemodialysis catheter may be used     instead. The problem with the use of catheters however is that they can become blocked due to     the formation of blood clots. Kidney physicians try to resolve occlusion of hemodialysis     catheters by injecting a medication called Alteplase which breaks the clot at the catheter     site. There is no consensus in the medical community as to how much of the medication should     be injected at the occluded catheter site. While some kidney physicians and studies recommend     the use of 1.0 mg of the medication at each occlusion site, others recommend that 2.0 mg of     the medication should be used. Thus, the purpose of this randomized clinical trial is to     compare the effectiveness of 1.0mg versus 2.0mg dose of alteplase in resolving blood clots in     hemodialysis catheters.      The investigators will recruit patients for the study from a regional hemodialysis unit that     is located in southwestern Ontario. Patients who agree to participate in this research and     experiences occlusion of their hemodialysis catheters will be divided into two groups; making     sure that this division is completely by chance. The first group will receive 1.0mg     alteplase, while the second will receive 2.0mg Alteplase. The investigators will collect     information on both groups and will run statistical analysis of these information to compare     the results of clot resolution between the groups.   "
81014|NCT02225522|"     The purpose of this study is to compare the effectiveness of rapid next generation sequencing     (NGS, such as whole genome sequencing1) with current practice to provide diagnostic or     prognostic information or treatment guidance in acutely ill neonates and infants,     particularly with respect to clinical care, cost and outcomes.   "
81039|NCT02225197|"     The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic     radiosurgery has on tumors near the critical structures of the eye (optic apparatus).      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the     CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and     effectively while sparing the adjacent optic apparatus and normal brain tissues from     receiving damaging doses of radiation.   "
80995|NCT02225769|"     Health professionals in developing countries have limited ability to identify children at     risk of dying and those in need of antibiotics. The main reasons are limited clinical skills     and time, unavailability of diagnostic tests (laboratory or x-ray) and non-adherence to     practice guidelines. Child mortality is therefore higher than it should be. Etiological     diagnostic tests (detecting microorganisms) may not always help since the distinction between     infection and disease and between mild or severe disease is not straightforward.     Overprescription of antibiotics is therefore widespread and leads to the development of drug     resistance. To address these challenges, decision charts for the management of febrile     illness will be developed and include i) few clinical parameters simple to assess, and ii)     POCTs results based on specific host markers that can discriminate between mild and severe     disease, pneumonia and upper respiratory tract infections, and unspecific fevers of bacterial     and of viral origin. This algorithm combining clinical and bedside laboratory tests will be     built on an electronic support (android tablet). The first objective of the study is to     assess the safety of new electronic decision trees that integrate simple clinical assessment     and POCTs results (oxygen saturation and a combination of specific biomarkers of     inflammation) as a triage tool to decide on admitting febrile children; the second objective     is to assess the usefulness and safety of new electronic decision trees that integrate simple     clinical assessment and POCT results (a combination of specific biomarkers of inflammation)     as decision-making tool to prescribe antibiotics to non-severe febrile children. The     development of such a tool will decrease mortality due to delayed admission, At the same     time, it will decrease irrational use of antibiotics, and hence drug pressure and emergence     of drug resistance, which represents one of the most important public health threat our world     is facing today. This project has the potential of huge applicability since it is     specifically designed for end-users with limited medical skills and low resources, as it is     the case in most areas of developing countries.   "
80996|NCT02225756|"     Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood     to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high     for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small     aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A     drug that would stop growth of small aneurysms would obviate aortic surgery, the current     treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the     possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine     A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake     liquid), every day during a short period of time. Efficacy of the drug will be evaluated by     measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety     analysis will evaluate the impact of the drug on renal function, blood pressure, and other     parameters. In case of adverse event during the drug administration phase, dose of the drug     or of the placebo will be decreased or administration stopped.   "
80998|NCT02225730|"     Stroke is caused by a sudden blockage of a blood vessel that delivers blood to the brain.     Unblocking the blood vessel with a blood clot removal device restores blood flow and if done     quickly may prevent the disability that can be caused by a stroke.      However, not all stroke patients benefit from having their blood vessel unblocked.      The aim of this study is to determine if special brain imaging, called MRI, can be used to     identify which stroke patients are most likely to benefit from attempts to unblock their     blood vessel with a special blood clot removal device. In particular, we will assess in this     trial whether a noncontrast MR imaging sequence, arterial spin labeling (ASL), can     demonstrate the presence of collateral blood flow (compared with a gold standard of the     angiogram) and whether it is useful to predict who will benefit from treatment.   "
80999|NCT02225717|"     The investigators project aims to identify, in pregnant women, discriminating molecules to     allow an early detection of women who will spontaneously deliver prematurely, suitable in     routine clinical practice.      Human parturition is tightly correlated with hormonal changes at the maternal-fetal interface     during pregnancy, that may control cell interactions and fetal membranes (the water bag)     remodelling. Precocious remodelling may lead to a premature onset of labor, associated or not     with premature rupture of membrane whether the cause is infectious or not.      In this regard, remodelled fetal membranes overlying the cervix may discharge signals that     could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of     delivery. Such information on delivery timing may be of great importance for an adequate     prediction that would change drastically the management of threatening preterm delivery.   "
81000|NCT02225704|"     This study aims to determine the safety and tolerability of Radium-223 when administered in     combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.   "
81001|NCT02225691|"     This study aims is to evaluate the effect of introducing paired testing on actual testing     frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled     diabetes patients in China.   "
81002|NCT02225678|"     Can a clinical test be developed that could help manage asthma symptoms?   "
81003|NCT02225665|"     The purpose of this study is to evaluate the safety and tolerability of repeat doses of     T-cell immunotherapy (SB-728mR-T) following cyclophosphamide conditioning.      CCR5 is a major co-receptor for HIV entry into T-cells. Disruption of CCR5 by zinc finger     nuclease (SB-728mR), blocks HIV entry into the T-cells, therefore, protects the T-cells from     HIV infection. Safety (primary outcome) and anti-viral effect (secondary outcome) of zinc     finger nuclease-mediated CCR5 disrupted autologous T-cells (SB-728mR-T) will be evaluated in     the study.   "
81036|NCT02225236|"     This project will develop and evaluate the initial effectiveness of an intervention training     executive functioning, metacognition, and self-regulation in preschoolers attending certain     high poverty Cincinnati preschools. Studies show that these skills are critical for school     performance, and that children with better executive functioning have better long term     outcomes. It is also important to intervene early when children are most likely to profit     because their brains are rapidly developing. There are some promising programs targeting     these skills in preschoolers, but few are available to teachers for implementation in the     classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based     program for the preschool classroom environment, and 2) to test the feasibility and initial     impact of the adapted program on executive functioning and school readiness in schools with a     high proportion of children from low income families.   "
81004|NCT02225652|"     TITLE: A Phase II Study of Dose Density Regimen with Fluorouracil, Epirubicin and     Cyclophosphamide at Days 1, 4 Every 14 Days with Filgrastim Support followed by Weekly     Paclitaxel in Women with Primary Breast Cancer.      PROTOCOL CODE: IRST 174.05      PHASE: II      STUDY DESIGN: Pharmacological, open-label, prospective, not randomized, monocentric trial      DESCRIPTION OF STUDY TREATMENT:      FEC + filgrastim x 3 cycles q 14-21 days      Day 1 and day 4 = FEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60 mg/m2     IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes).      From day 7 until hematological recovery = Filgrastim 300 microg s.c.      After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly for     8 cycles, at day 1).      NUMBER OF SUBJECTS: in the first stage, 11 patients have been planned, with an additional 27     patients to the second stage if at least 7 patients complete the planned treatment.      OBJECTIVES      Primary objective: this trial is designed to assess feasibility of the proposed regimen with     regard to toxicity and deliverability. Tolerability is defined as absence of any grade 3 or     higher nonhematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might     be a consequence of the administration of filgrastim). Deliverability is measured as the     percentage of patients who complete the planned treatment.      Secondary objectives:        -  Relapse-free survival: measured from enrollment to the first date between date of          documented relapse (or death) or date of last tumor assessment (if no documented          relapse), or the date of last tumor assessment before the start of any further antitumor          therapy not planned in the protocol.        -  Overall survival: measured from enrollment to the date of death of any cause or last          follow-up.      CORRELATIVE/SPECIAL STUDIES: to evaluate retrospectively potential biomarkers of activity and     toxicity of this regimen, blood and plasma samples until 15 mL each one will be collected at     study entry, before first docetaxel administration and 3-4 weeks after last docetaxel     administration. Moreover, a paraffin block or specimens of the primary tumor will be     collected for biological studies.      STATISTICAL CONSIDERATIONS: This trial is designed to assess feasibility of the proposed     regimen with regard to toxicity and deliverability.      Tolerability is defined as absence of any grade 3 or higher non-hematologic toxicity     (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the     administration of filgrastim).      A Simon two-stage design has been used with a 60% tolerability rate considered not promising     and an 80% tolerability rate as promising, and probability of type I and type II errors has     been set to be 0.10.      In the first stage, 11 patients have been planned, with an additional 27 patients to the     second stage if at least 7 patients complete the planned treatment. The regimen would be     considered tolerable and worthy of further study if at the end of the trial 27 out 38     patients complete the planned treatment.   "
81005|NCT02225639|"     The primary objective of this study is to assess the time of onset and time course of     efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a     simulated adult workplace environment (AWE) setting, as measured by the PERMP (an     individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours     post-dose.   "
81006|NCT02225626|"     Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male     subjects as well as to investigate pharmacokinetics, safety and tolerability   "
81007|NCT02225613|"     Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns     young sportsmen. Consequences are limitation in physical and sporting activities and at work.      Main objective: to compare water and traditional rehabilitation after cruciate ligament     injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities     development.   "
81008|NCT02225600|"     The study will examine behavioral patterns and underlying neural correlates which distinguish     patients with borderline personality disorder (BPD) from healthy subjects as they participate     in a two-person trust game and will determine whether administration of intranasal oxytocin     (OT) will normalize trust game performance and concomitant neural processing in the BPD     group.   "
81009|NCT02225587|"     The purpose of this study is to evaluate the safety and immunogenicity of sequential     administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and     older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to     pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as     measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and     Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and     placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as     measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by     Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.   "
81010|NCT02225574|"     The goal of this clinical research study is to find the highest tolerated dose of the     combination of nilotinib and MEK-162 that can be given to patients with CML or acute     leukemia. Researchers also want to learn if the drug combination can help to control the     disease. The safety of the drug combination will also be studied.   "
81011|NCT02225561|"     Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in     France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic     resuscitation survival after cardiac arrest remains low (1-8%) and has not changed     significantly over the past five decades.It has recently been shown that the combination of     different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with     automated compression / decompression and an impedance threshold device, can increase the     rate of return of spontaneous circulation and short and long term survival after cardiac     arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium     nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a     mechanical component: cardiopulmonary resuscitation with automated mechanical external chest     compression and an impedance threshold deviceb) a pharmacological component: sodium     nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and     improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of     spontaneous circulation rate during cardiac arrest.   "
81012|NCT02225548|"     The purpose of this study is to see if selegiline and tadalafil (generic for Cialis®) results     in an improvement in Erectile dysfunction (ED) in male patients with Parkinson's disease (PD)     and moderate ED. Male PD patients who have an incomplete response to tadalafil alone will be     given both medications to see if the addition of selegiline improves ED symptoms more than     tadalafil alone. It is common practice for a medical doctor to prescribe these two drugs to a     patient like you. However, there have been no studies conducted to examine the effects of     these medications when taken together.      Selegiline is normally prescribed for PD patients that are taking carbidopa/levodopa who are     not receiving complete benefit from carbidopa/levodopa.      Tadalafil is normally prescribed to men who have erectile dysfunction and/or benign prostatic     hyperplasia (BPH).   "
81013|NCT02225535|"     The purpose of this project is to compare usual care for chronic low back disorders in a     rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy     (PT) into a rural health care team:        1. in-person PT assessment, where the PT travels from an urban center        2. interprofessional Telehealth assessment where the local NP is joined by a PT via          Telehealth.      The project will evaluate health, systems and process outcomes, comparative effectiveness and     costs of the three methods of assessment. The hypothesis is that an interprofessional     Telehealth assessment with be as effective as an in-person PT assessment, but more effective     than usual care.   "
81015|NCT02225509|"     1. Principal objective:           The primary objective of this study is to validate the diagnostic performance of a Dx15          molecular test based on molecular transcriptomic signatures previously identified in          distincts cohorts of samples to determine the malignant or benign profile of a thyroid          nodule with indeterminate cytological analysis. The target population includes          categories III [Follicular lesion of undetermined significance or Atypia of undetermined          significance (FLUS/AUS)] and IV [Follicular neoplasm / Suspicious for follicular          neoplasm (FN/SFN)] of the Bethesda classification.           The expected target performance of the Dx15 molecular test in this target population is          95% for specificity with a lower limit of the 95% confidence interval of 87%, and 75%          for sensitivity.        2. Secondary objectives:             -  To assess the performance of the Dx15 test in samples collected during the study by               fine-needle aspiration (FNA) in each and in all of the indeterminate Bethesda               classification categories (categories III, IV and V: suspected malignancy)             -  To assess the performance of the TI-RADS ultrasonography score for diagnosing               thyroid cancer in patients presenting with a thyroid nodule and having available               cytological analysis results.             -  To check the potential of performance of the molecular signature as well as of its               combination with other tests by applying it in a blind manner to samples collected               from patients presenting with thyroid nodules and whose aspiration biopsy result is               benign (Bethesda category II), malignant (Bethesda category VI) or non-diagnostic               (Bethesda category I)             -  To assess the performance of mutation tests (isolated mutations, chromosomal               rearrangements) for diagnosing thyroid cancer in patients presenting with a thyroid               nodule and with available cytological results.             -  To estimate the performance of the combination of the Dx15 test result and other               diagnostic tools such as mutation tests and/or the TI-RADS score to diagnose               thyroid cancer in patients presenting with a thyroid nodule and having an               indeterminate cytology result (especially AUS/FLUS and FN/SFN). The combination of               Dx15 diagnostic test results with other study parameters will also be considered in               order to establish the option of an algorithmic approach for the diagnosis of               thyroid cancer.             -  To compare the results of cytological and histological analyses obtained in the               centres and by centralised reading and assessment of the impact of its results on               the other study analyses and parameters.             -  Additional analyses deemed relevant on the basis of various parameters and data               collected during the study.        3. Objective of exploratory research:             -  The use of all or part of the FNA samples for the purpose of research as part of               thyroid cancers, especially with the objective of optimising or identifying               additional molecular signatures.   "
81016|NCT02225496|"     Standard-of-care treatment options for oropharyngeal cancer often result in long-term side     effects that interfere with normal quality of life. A minimally-invasive transoral robotic     surgery (TORS) approach has been developed to operate on the disease site while affecting the     surrounding tissue as little as possible. Researchers think that this approach may help to     control the disease and avoid such long-term side effects.      The goal of this clinical research study is to learn if minimally-invasive transoral robotic     surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through     the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.      Researchers also want to learn if this surgery affects participants' ability to speak and     swallow.   "
81017|NCT02225483|"     The is study will examine whether variation in clinical bleeding frequency and severity among     boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in     laboratory measurements of platelet activity.   "
81018|NCT02225470|"     This study is designed as an open-label randomized parallel two-arm multicenter efficacy,     pharmacokinetics and safety study of intravenously administered eribulin versus intravenously     administered vinorelbine in Chinese population. Eligible female subjects will have measurable     disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for     assessment of disease.   "
84140|NCT02184676|"     The purpose of this study is to determine whether early immunological markers (activation of     autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in     children born from type 1 diabetic parents.   "
81019|NCT02225457|"     Obesity results from complex interactions between genetic and environmental factors, and are     strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is     defined as an excessive fat accumulation that presents a risk to health, a risk that is     highly dependent upon the type of adipose tissue accumulation, whether visceral or     sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory     cells accumulation. Because of the well known sexual difference in fat accretion, this     obesity-associated risk may also be very different for men and for women. In addition, recent     data indicate that various factors such as the intestinal microbiota, but also the dietary     intake of protective nutrients might be important determinants of the metabolic complications     of obesity.      Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue     accumulation during a period of controlled caloric over-nutrition, both in men and in women;     2) evaluate the potential protective effects of a supplementation with polyphenols on insulin     resistance and other metabolic adaptations.   "
81020|NCT02225444|"     OsteoAMP is an allograft (transplantation of part of one person to another person) derived     growth factor rich bone graft for use in spinal fusion. The study is designed to obtain a     higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to garner     FDA regulatory approval. This is a prospective, non-randomized, non-controlled, multi-center     study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in patients with     degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild     degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to undergo     instrumented, posterolateral spinal fusion surgery as part of their medical treatment and     comply with the study eligibility criteria will be given the opportunity to consent and be     entered into the study.   "
81021|NCT02225431|"     The aim of this study was to evaluate, in patients with lower fluid status defined by     bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are     associated with different volume expansion and differing risks for CI-AKI in patients     undergoing coronary angiographic procedures.   "
81022|NCT02225418|"     The TQL block may prove a valuable method for treating postoperative pain following scopic     removal of the gall bladder.      The trial will compare active TQL block versus placebo TQL block after said operation.      The hypothesis is that active TQL block significantly will reduce postoperative pain     following scopic removal of the gall bladder compared with placebo TQL block.   "
81023|NCT02225405|"     The goal of this clinical research study is to learn if it is safe to give nintedanib in     combination with cisplatin and docetaxel before surgery to patients with NSCLC. Researchers     also want to learn if the drug combination can help to control NSCLC before surgery.   "
81024|NCT02225392|"     Approximately 5% of asthma patients suffer from severe asthma that is characterized by     frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of     health care resources. Therefore, there is a strong need for improved therapeutic strategies     for these patients. Insight in the pathogenesis and molecular pathways active in severe     asthma is crucial to reach this goal.      Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma     that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy.      Hypothesis:      BT-induced clinical improvement in severe asthma is a consequence of reduction in airway     smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural     innervation and/or vascular integrity resulting in altered airway remodelling. BT target     identification and severe asthma phenotyping are critical for improved patient selection for     BT and fundamental to discover novel, specific signalling pathways active in severe asthma.   "
81025|NCT02225379|"     Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines     an array of non-invasive sensors which monitors the patient's physiological parameters (heart     & respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch     device.      The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in     hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to     reference methods      The proposed study will be consisting of two main segments:      The primary aim of segment 1 of the study is data collection and calibration of the Hypo     Sense sensor prototype compared to standard invasive reference glucometer.      The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance     in detecting hypoglycemic events.      During the first segment of the study we intend to collect in parallel measurements of blood     glucose using reference method (capillary glucometer) and continuous data generated by the     non- invasive study device during approximately 4 hours, in which a hypoglycemic event will     be induced.      The reference and study device data will be analyzed using multivariate regression model to     formulate a calibration algorithm model. This model will translate the set of the     physiological recorded parameters into detection of hypoglycemic events.      During the second segment of the study we intend to evaluate the validity of the Hypo Sense     sensor ability to detect hypoglycemic events compared to standard invasive reference method     (capillary glucometer).   "
81026|NCT02225366|"     The goal of this clinical research study is to find the appropriate dose of LL37 that can be     given to patients with melanoma. Researchers also want to learn if LL37 can stimulate the     immune system to help control the disease.   "
81027|NCT02225353|"     Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized     progesterone for the prevention of preterm delivery, established through spontaneous birth     before gestation weeks 32 (31 6/7) and 34 (33 6/7), when the pessary is inserted during weeks     16th and 24th and removed at 36 6/7 weeks in pregnant women at high risk of premature birth.   "
81054|NCT02225002|"     CD40, a member of the Tumor Necrosis Factor receptor superfamily, is expressed on many tumor     types, including melanoma, prostate, colon, breast, renal, pancreatic, and nonsmall cell lung     cancers. In preclinical models, activation of CD40 results in increased antigen presentation     and induction of apoptosis. CD40 is also expressed on antigen presenting cells (APCs) (B     cells, dendritic cells, monocytes) and is a key regulator of both cellular and humoral immune     responses. Activation of CD40 by CP-870,893, an agonistic anti-CD40 monoclonal antibody,     enhances host immune responses and abrogates the growth of tumors independently of the     expression of CD40 on tumor cells. Therefore, it is hypothesized that therapeutic     intervention with CP-870,893 may be beneficial to a large number of cancer patients either     through an immunomodulatory effect or through a direct effect on CD40-positive tumor cells.   "
81028|NCT02225340|"     Familial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by     mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles     from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma     LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH     carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying     defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9)     regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation.      The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein     (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of HeFH     subjects.      The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C     concentration variability and are associated with Lp(a) levels.   "
81029|NCT02225327|"     Similar to children, adults frequently visit outpatient clinics to get two or more kinds of     vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and     tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine,     etc. This study is intended to evaluate the immunogenicity and safety of concomitant     administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59     adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.   "
81030|NCT02225314|"     Computer-Based Cognitive Training for Individuals with Parkinson's Disease is a 3-arm     randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control     (AC) training program to evaluate the feasibility of empirically supported computer-based     cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD) with     Mild Cognitive Impairment (MCI). This pilot study aims to address the need for increased     interventions to target non-motor symptoms associated with PD.   "
81031|NCT02225301|"     Phase 1 was a randomized control trial that used a test-retest model to evaluate the impact     of iLook Out for Child Abuse, an online, interactive learning module about reporting     suspected child abuse. Delivered via a learning management system to early childhood     professionals who work with infants and young children, this study assessed iLookOut's effect     on 1) knowledge about reporting suspected child abuse; 2) attitudes toward reporting     suspected child abuse; and 3) preparedness to protect children at risk.      Findings from Phase 1 were that iLookOut will improved knowledge, changed attitudes, and     increase self-reported preparedness of early childhood providers to report suspected child     abuse.      Phase 2 of this trial is an open-enrollment study that records pre-/post- data on the same     measurements as Phase 1, and is available for use (free of charge) for all childcare     providers in Pennsylvania at https://www.ilookoutforchildabuse.com.   "
81032|NCT02225288|"     This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total     of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to     administer one E2022 tape to designated sites.   "
81033|NCT02225275|"     The goal of this clinical research study is to learn if the combination of lenalidomide and     obinutuzumab can help to control CLL or SLL. The safety of this drug combination will also be     studied.   "
81034|NCT02225262|"     The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients     with early stage prostate cancer.      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the     CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and     effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile     bulb, and bowel) from receiving damaging doses of radiation.   "
81035|NCT02225249|"     Lung transplantation is a well established method for surgical therapy for patients with end     stage pulmonary disease.      The investigators seek to determine to which extent the pulmonary vascular barrier gets     harmed during lung transplantation and whether pulmonary edema after reperfusion can be     monitored with measurement of extravascular lung water index (ELWI).      Additionally the investigaors are going to evaluate the correlation between ELWI and shedding     of the endothelial glycocalyx.      The study is designed as a prospective observational cohort study.   "
81037|NCT02225223|"     The purpose of this study is to evaluate treating painful metastatic lesions in vertebral     bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral     augmentation (VA) prior to or following radiation therapy.   "
81040|NCT02225184|"     Background:      - Differences in peoples genes can make them respond to drugs in different ways. Methadone     and buprenorphine are two drugs used to treat drug addiction. A study showed that African     Americans with a certain genetic marker did better using one kind of drug treatment over the     other. Researchers want to see if they can repeat these findings. They also want to study     other things that affect how well people do in treatment.      Objective:      - To see if certain genetic markers and other facts about a person s life can predict how     well they do in treatment for addiction to opioids and cocaine.      Eligibility:      - African American adults age 18 and over. They must be former or current participants in an     Archway Treatment Clinic study. They must have been on a stable dose of either study drug for     at least 12 weeks. They also must have given urine samples regularly for at least 10 weeks.      Design:        -  Participants will come to the clinic for 1 visit lasting about 2 hours.        -  Participants will give 1 teaspoon of blood for genetic testing. They will be asked if          their sample can be used in future studies.        -  If researchers cannot get enough blood, they will do a cheek swab. This will collect          skin cells for genetic testing.        -  Participants will fill out 3 questionnaires.        -  Results of genetic testing and answers to questionnaires will be kept private.   "
81055|NCT02224989|"     This pilot project evaluates the efficacy of a mind-body awareness training intervention,     Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for     relative therapeutic benefit will be indicated by the difference in outcomes from pre- to     post-intervention for PTSD as the primary outcome.   "
81056|NCT02224976|"     The investigators propose a prospective, longitudinal, department funded study protocol to     evaluate whether changes in energy availability, during a period of highly intensified     exercise training, will increase bone turnover markers and decrease ovarian function and     exercise performance, in a dose-dependent fashion in competitive female athletes.   "
81041|NCT02225171|"     Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) by which     embryos, created through in vitro fertilization (IVF), can be screened for genetic conditions     or traits before they are implanted into a woman s uterus. Within the past few years, a     controversial non-medical use of PGD has gained recognition as having possible significant     ethical implications. Non-medical sex selection (NMSS) describes the use of PGD technology to     choose the sex of a child for social, as opposed to medical, reasons. In the US and a select     few other countries, it is legal to use NMSS for family balancing, or the intentional     selection of an underrepresented sex to balance a family where the majority of the children     are of one sex. Proponents of family balancing believe that NMSS is an expression of     reproductive autonomy and is ethically acceptable on those grounds. Opponents are more likely     to cite beneficence (toward the existing children and the potential future child) and justice     (resource allocation and access, for example) as the basis for concerns around NMSS and     family balancing specifically. In the US and other countries, healthcare providers (HCPs) are     often the gatekeepers to this technology. There is little research exploring the experiences     of HCPs with PGD and NMSS. The Moral Experience framework (Hunt and Carnevale, 2011) is     useful for understanding the potential concerns of HCPs as well as their feelings and     behaviors evoked by lived and hypothetical experiences around NMSS. Also of interest is how     HCPs feel that decisions about NMSS are made and their preferences as to how they should be     made. Finally, there is concern that NMSS may be the first in a line of non-medical uses for     PGD and that a slippery slope toward what some describe as designer babies will follow. We     are interested in eliciting the traits that HCPs believe are hypothetically appropriate or     inappropriate for PGD and how they make the distinction. Interviews with HCPs (OBGYNs and     reproductive endocrinologists) on these topics will be transcribed and subjected to thematic     analysis in order to identify common themes. An understanding of the experiences and     attitudes of this stakeholder population can help clarify current issues at individual,     societal, and global levels and future directions for research and policy.   "
81042|NCT02225158|"     Background:      Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide. It     is caused by a bacteria that enters through the lungs and can spread elsewhere in the body.     People with latent TB have the bacteria that lie dormant but can become active and cause     disease. These people are offered treatment to prevent development of active TB. Worldwide, a     lot of people with LTBI also have a parasitic worm called a helminth that can stay in the gut     or the blood. These parasites can affect the immune system and cause diseases like TB to     become worse. Researchers want to see how helminth infection makes it harder for people to     fight TB infection.      Objectives:      - To study how the immune system of people with latent tuberculosis infection (LTBI) acts to     prevent development of active TB. Also, to study how helminth infection might affect this     immune response.      Eligibility:        -  Adults age 18 70 with LTBI as defined by an approved blood test called QuantiFERON TB          Gold.        -  No evidence of infections like Hepatitis or HIV        -  Pregnant subjects and subjects taking medications that suppress the immune system are          not eligible.        -  Have not received prior treatment for LTBI. Participants might be still eligible if          prior treatment for active TB has been received      Design:      Screening phase:      - Participants will be screened with medical history, physical exam, and blood tests for     other infections/conditions which might affect the immune system. They will have testing for     active TB i.e. blood testing as well as testing of their spit, scans and X-rays.      Baseline phase:        -  Only eligible participants will be entered into the study.        -  Participants will have interviews, medical history, and physical exam.        -  Blood will be drawn from an arm vein for testing.        -  Participants will collect stool samples at home for 3 days in a row to test for helminth          infection..        -  Participants may have apheresis. Blood cells are removed by needle. They pass through a          separator machine which returns everything but the cells back to the participant.        -  Participants may have procedures at the start and end of the study that let researchers          look into the lungs and collect cells.      Study phase, about 2 years:        -  All participants will be offered treatment for LTBI which lasts 6-9 months.        -  Participants being treated for LTBI will have about 11 study visits. They will visit          monthly for 9 months while on treatment, then 6 and 12 months after treatment.        -  Participants not eligible/refusing treatment for LTBI will be made aware of active TB,          then have 3 other visits, about 6, 12, and 24 months after the baseline visit.        -  Participants who have helminth infection will receive appropriate treatment.        -  All participants will have blood drawn at each visit.   "
81043|NCT02225145|"     Background:      - Some treatments for cancer or other diseases can lead to infertility in women. These     treatments include chemotherapy, some stem cell transplants, and pelvic radiotherapy. They     are called gonadotoxic therapies. Women can now have their eggs frozen before they have these     treatments. This may allow them to get pregnant later. Researchers want to learn more about     this technology and processes.      Objectives:      - To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about     the effects of these therapies.      Eligibility:      - Women at least 18 years old who are past puberty and before menopause. They must be     scheduled to have gonadotoxic therapies.      Design:        -  Participants will be screened with medical history and blood and hormone tests. They          will also have a physical exam and transvaginal ultrasound.        -  Ovary stimulation: participants will have medications injected under the skin. These          increase the chance of fertility. This phase will take about 8 20 days. Participants          will have blood drawn and transvaginal ultrasound daily or every other day. Some          participants will also have blood thinner injected daily.        -  Egg retrieval: participants will check in to the hospital. Eggs will be removed with a          needle during a short surgery. Participants will be awake but sedated.        -  Participants may stay overnight in the hospital.        -  They will return every 1 3 days for 1 3 weeks for blood tests.        -  Mature eggs will be frozen after egg retrieval and immature eggs (which cannot be          fertilized for clinical use) will be used for research. Participants can use their eggs          in the future at outside, private fertility clinics to try to become pregnant. If the          eggs are stored for more than 5 years, participants must pay for storage.   "
81044|NCT02225132|"     Background:      - Sickle cell disease (SCD) is a blood disease. The drug hydroxyurea (HU) is approved to     prevent pain crises in people with SCD. Researchers want to see how higher doses of HU affect     the blood. This will help them learn about the right dosage of HU to give to people with SCD.      Objective:      - To improve hydroxyurea dosing in people with SCD.      Eligibility:      - People age 15 or older with homozygous SCD (HbSS).      Design:        -  Participants will be screened with medical history, physical exam, medication review,          and blood and urine tests.        -  Participants will be in the study for about 15 months.        -  First 3 months: monthly study visits with blood and urine tests.        -  After 3 months: participants will take HU as a capsule by mouth. If you are already          taking HU, your dose will be increased.        -  Within a month of starting or increasing HU: participants will keep a daily pain diary          for 2 weeks. They will have an echocardiogram (ultrasound) of the heart, a 6-minute walk          test. They will complete a quality-of-life questionnaire.        -  Participants will visit every month until they reach their highest tolerated dose of HU.          They may need to come as often as every week sometimes to closely monitor their blood          counts. Then they will alternate a phone call one month and a visit the next. At the          visits, participants will bring their pill bottle, answer questions about side effects,          and have blood tests.        -  Every 2 months, participants will have a medical history, physical exam, and blood          tests.        -  Every 4 months, participants will have blood and urine tests. They will also complete          another 2-week pain diary and quality-of-life questionnaire.        -  About 12 months after starting or increasing HU, participants will have blood tests, an          echocardiogram, and a 6-minute walk test.   "
81094|NCT02224482|"     The purpose of this study is to test how well an online program designed to help prostate     cancer survivors cope with changes caused by their cancer or treatment works compared to     standard print educational materials from the National Cancer Institute (NCI).   "
84317|NCT02182375|"     Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI     201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to     investigate safety and tolerability.   "
81053|NCT02225015|"     This study aims to develop a follow-up telephone-based genetic counselling (FTGC)     intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in     the past. Typically, when women undergo genetic testing, they receive standard genetic     counselling prior to testing in order to fully understand the procedure and associated     implications. If a woman's genetic test results are positive for a mutation, cancer     prevention options are then discussed with a counsellor. However, in Canada, there is     currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing     guidance and support about latest risk reduction strategies. Standard care relies on women     making contact for any follow-up questions or concerns they may have. As a result, these     women might not have the most current information regarding genetic risk assessment and     prevention options. Therefore, individuals are being asked to participate in this study to     aid research about the efficacy of FTGC in women with a BRCA mutation.   "
81057|NCT02224963|"     The purpose of this randomized trial is to examine the effectiveness of a psycho-social     Preventive Problem Solving Intervention on emotional well-being, change in future outlook,     and vision functioning in 250 Age-related Macular Degeneration patients 60 and older.   "
81045|NCT02225119|"     Background:      - Maculopathies are eye conditions that affect the center of the retina. Retina health     depends on the RPE, a layer behind the retina. A new test may measure the health of the     central retina and RPE.      Objective:      - To use the focal electro-oculogram test to understand how the central retina and RPE are     affected in maculopathies.      Eligibility:        -  People at least 10 years old with a maculopathy.        -  Healthy volunteers.      Design:        -  Participants will be screened with medical and eye history and an eye exam. Pictures          will be taken of the eyes.        -  Their eyes may be dilated.        -  They may have a field test. They will look into a lens and press a button when they see          a light. First, they may sit in the dark for 40 minutes.        -  Participants will have 1 7 visits over 18 months.        -  Their vision will be tested and eye pressure measured.        -  Their pupils will be dilated with eye drops and researchers may take pictures of the          retina and the inside of the eye, and measure the thickness of the retina.        -  Participants will have an electro-oculogram. They will look at a 2 LED lights and follow          them back and forth for 10 seconds once per minute. Participants will be in darkness for          15 minutes and in light for 20 minutes. One skin electrode will be placed on the nose          and one next to the eye.        -  Participants with maculopathy will also have:        -  Field test.        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses. A          small metal electrode will be taped to the forehead. Participants will watch flashing          lights and try not to blink. First, they may sit in the dark for 40 minutes.   "
81046|NCT02225106|"     OBJECTIVES:      Deficits in memory, attention, cognitive, and executive functions are the most common     disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is     implicated in these neural functions and dopaminergic pathways are recognized to be     frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate     (Ritalin ). Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine     transporters (DAT) and blocking re-uptake. PET with methylphenidate challenge to measure     tonic DA release provides valuable insight into the molecular basis of attention-deficit     hyperactivity disorder (ADHD) and addiction, as well as practical information regarding     likely effectiveness of therapy (1). The objectives of this study are to use PET imaging with     [11C]-raclopride, a D2/D3 receptor ligand, before and after administering methylphenidate, to     measure endogenous DA release in patients who are experiencing problems with cognition,     attention and executive function in the chronic stage after TBI. In addition, we will use TMS     to test short intracortical inhibition, a gamma-aminobutyric acid receptor A (GABAA) -     mediated phenomenon, which is under partial DA control, as a measure of dopaminergic activity     on and off      methylphenidate.      STUDY POPULATION:      Males and females (n=30), between the ages of 18 and 55 years in the chronic stage after TBI     who experience deficits in neuropsychological function from TBIs incurred 6 months after the     injury, will be recruited from military treatment facilities or civilian clinics when     presenting for clinical management of TBI or postconcussive symptoms.      DESIGN:        1. Study participants will be evaluated using brain MRI, psychometric measures adapted from          the TBI Common Data Elements, attention tests and information about details of the          injury and experience of post-concussive symptoms will be recorded. Transcranial          magnetic stimulation (TMS) with placebo and with methylphenidate (60 mg by mouth)          challenge will be performed to predict a stimulant response.        2. Subjects will be studied with [11C]-raclopride PET in two imaging sessions. One session          will be after administration of placebo and the other after methylphenidate, 60 mg by          mouth. Both placebo and methylphenidate will be given 60 minutes prior to injection of          [11C]-raclopride to allow for peak uptake of methylphenidate in the brain. The binding          potential of [11C]-raclopride relative to a non-displaceable reference region          (cerebellum), BPND, will be used as a measure of D2/D3 receptor availability. The          difference in BPND between methylphenidate and placebo ( BPND) is used to measure of          tonic DA release.        3. Subjects will then be treated with oral methylphenidate, using a forced titration up to          a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests          are repeated.      OUTCOME MEASURES:      The primary outcome is change in information processing speed      during neuropsychologic testing   "
81047|NCT02225093|"     This study evaluates how once daily enzalutamide affects the metabolism of caffeine and     dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and     their metabolites in plasma.   "
81048|NCT02225080|"     The purpose of this study is to gather information about post-market performance of DuraGen     Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market     clinical data to evaluate the presence of unintended residual risks associated with the use     of DuraGen Secure that were not anticipated or identified in the animal studies, bench     studies or clinical evaluation report.   "
81049|NCT02225067|"     The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH     Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers   "
81050|NCT02225054|"     The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given     either intravenously or as part of the interscalene nerve block solution, prolongs pain     relief following shoulder surgery compared to local anesthetic solution alone.   "
81051|NCT02225041|"     The purpose of this study is to determine the relationships between sedative exposure during     pediatric critical illness and long-term neurocognitive outcomes. We will test for drug- and     dose-dependent relationships between sedative exposure and neurocognitive outcomes along the     early developmental spectrum and will control for baseline and environmental factors, as well     as the severity and course of illness.      Hypotheses:        1. Greater exposure to benzodiazepines and/or ketamine will be associated with lower IQ          even when controlling for severity of illness, hospital course, and baseline factors. In          addition, benzodiazepines and/or ketamine will negatively affect other aspects of          neurocognitive function.        2. Younger children exposed to benzodiazepines and/or ketamine will have worse          neurocognitive outcomes than older children with similar sedative exposure and severity          of illness.   "
81052|NCT02225028|"     People with spinal cord injuries (SCI) are among the least physically active groups in our     society. Approximately 1 in 4 healthy young persons with spinal cord injury (SCI) does not     have sufficient fitness to perform many essential activities of daily living. About 50% of     people with SCI engage in no leisure time physical activity. That is, they do not wheel or     walk for pleasure, don't play a sport, don't exercise at home or go to a gym. As a result of     this, cardiovascular, endocrine and metabolic conditions adversely affect the health of a     large segment of the SCI population. Fortunately, clinic and/or laboratory-based aerobic     conditioning and circuit training studies provide compelling evidence that people with SCI     can improve their cardiorespiratory fitness and by doing so can partially reverse     cardiovascular disease (CVD) risk factors, enhance Quality of Life (QOL) and improve elements     of subjective well-being. While intensive, clinic-based, supervised exercise programs can     improve the fitness and health of persons with SCI, the value of these findings for the SCI     population is limited because the vast majority of people do not have access to these     specialized programs and facilities. The gap that the present study addresses is: How can we     extend the benefits of increased exercise and physical activity to more people with SCI?      The goal of this study is to evaluate the feasibility of an individually tailored, home- or     community-based, telephone delivered intervention that uses evidence-based behavioral and     motivational counseling to increase daily physical activity and exercise.   "
81058|NCT02224950|"     The study will primarily focus on evaluating the benefits of using a     lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate     eczema. More specifically, the study will focus on the upper limb area in these patients and     will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can     improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell /     chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using     the following four variables: an eczema severity index, amount of itching, bacteria levels in     the affected areas of skin, and amount of water loss in the affected areas.   "
81059|NCT02224937|"     The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics     of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of     blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application.     Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time     points.   "
81060|NCT02224924|"     The purpose of this study is to compare two methods that are currently used at the end of a     CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the     chance of air leaking out of the hole. The two techniques consist of either injecting a very     small amount of your the blood called a blood patch into the biopsy hole or injecting a     gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed     into the body.   "
81061|NCT02224911|"     This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial     thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as     well as to gather data for the design of future studies.   "
81062|NCT02224898|"     The research objective of this pilot study is to test the feasibility of a mobile electronic     mindfulness therapy service for patients with definite or suspected chronic pancreatitis.      A secondary aim will be to determine the effect of the intervention on a symptom     severity/global assessment of improvement for patients with chronic pancreatitis. The     investigators hypothesize that a one-month period of daily mindfulness therapy delivered via     a phone messaging service will reduce symptoms.   "
81063|NCT02224885|"     This study is a prospective study in order to demonstrate the technical feasibility and     safety of doing endomicroscopic imaging during interventional radiology procedure in two main     indications: lung and liver.      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The     proposed study is a feasibility study.   "
81064|NCT02224872|"     Our primary objective is to determine if it is feasible for SAA patients to be transplanted     using non-myeloablative conditioning and post transplantation cyclophosphamide with partially     HLA-mismatched donors.   "
81065|NCT02224859|"     While using the device as a cushion, the passive distribution of pressure over bony skull     prominences of infants will protect against formation of pressure ulcers.   "
81066|NCT02224846|"     The purpose of this study is to evaluate the safety and effectiveness of the study drug,     taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED).     The study will last about up to 25 months for each participant.   "
81067|NCT02224833|"     PHARM-PC study is based on identify potentially inappropriate prescriptions (PIP) and     delivery therapeutic appropriateness recommendations from the pharmacist to the physician and     about drugs prescribed for elderly and polypharmacy patients in primary care. Assessment of     the impact of pharmacist intervention on the appropriateness of prescribing and both health     outcomes and economic outcomes will be done.   "
81068|NCT02224820|"     IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor     specific antibodies to reduce the antibody load and thus enable kidney transplantation. IdeS     antibody reducing efficacy and its safety will be studied.   "
81069|NCT02224807|"     This pilot/feasibility trial seeks to explore whether an acute bout of negative energy     balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese     postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast     cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2     study arms: 1) an Attention Control Group that receives instruction on dietary approaches to     correct nutritional deficiencies and progressive resistance training (PRT) that targets the     arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and     guidance to correct nutritional deficiencies plus an intensive intervention to promote a     1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study     will explore and contrast changes in body mass index (BMI) observed from enrollment to the     time of surgery in the experimental vs. attention control arms, and also monitor changes in     energy intake and physical activity. These changes will be studied in relation to the     following endpoints: a) changes in select circulating biomarkers and gene expression related     to cancer progression, hormonal status, inflammation and other energy-related factors; b)     rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor,     Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and     phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated     Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor     tissue and blood will be examined from pre-to-post-intervention, this study will provide     exciting new data that can elucidate pathways by which energy balance affects breast cancer     progression. Although longer term weight loss is recommended for overweight and obese breast     cancer survivors, it is not known whether placing the body in a state of negative energy     balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and     the host environment occur with short-term, pre-surgical weight loss, this study provides     proof of concept that weight loss may offer an acceptable and complementary treatment option     that could be combined with standard therapies.   "
81070|NCT02224794|"     The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits     associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive     conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR     protocol include: appropriate patient selection, bilateral percutaneous access, no general     anesthesia, no ICU admission post procedure, and next day discharge.   "
81072|NCT02224768|"     To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in     terms of awareness about these tools, their utilization, knowledge and comprehension of     Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional     (HCP)s and patients   "
81073|NCT02224755|"     The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by     demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of     advanced, refractory, left ventricular heart failure.   "
81101|NCT02224391|"     The goal of this research study is to learn if a smartphone-delivered intervention combined     with nicotine replacement therapy can help you to quit smoking.   "
81074|NCT02224742|"     Diabetic foot ulcers are the source of considerable suffering and cost and there are     currently no wound care products available that have been demonstrated to improve healing, or     that are cost effective. There have however been a small number of studies which have     examined the use of platelets or fluid derived from platelets, either from the patient's own     blood or from blood bank products. These have suggested some promise, but have suffered from     technical difficulties in making a suitable wound care product or the volume of blood     required to derive the product. It is thought that the reason why they may work is that     growth factors released by the platelets may stimulate the wound to heal.      This study will be a formal, randomised controlled trial to assess a new device for creating     a wound care product which is a plug or patch comprising fibrin, white cells and platelets     derived from 18 mls of the patients own blood. The application of this fibrin/white     cell/platelet patch to the patients wound on a weekly basis will be compared with usual best     care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25     centres in the United Kingdom, Denmark and Sweden.   "
81075|NCT02224729|"     This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib,     and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used     in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways     to stop the growth of cancer cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride     with bortezomib and dexamethasone may kill more cancer cells.   "
81076|NCT02224716|"     The purpose of this study is to evaluate the impact of a structured package (bundle) in     reducing the use of antimicrobials and hospital stay of patients with community-acquired     pneumonia (CAP), and no increase in mortality of these patients in different hospitals.   "
81077|NCT02224703|"     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children     and young adults with Dravet syndrome.   "
81078|NCT02224690|"     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in subjects     with Lennox-Gastaut syndrome.   "
81079|NCT02224677|"     This study is a multi-center, longitudinal cohort study of 125 infants with craniofacial     microsomia (CFM) and 100 infants without craniofacial anomalies. Participants will undergo a     series of evaluations between 0-3 years of age to comprehensively evaluate the developmental     status of infants and toddlers with CFM. This research design will also explore specific     pathways by which CFM may lead to certain outcomes. Specifically, the study explores (1) the     longitudinal relations between facial asymmetry and emotion-related facial movements and     socialization; and (2) associations among ear malformations, hearing and speech deficits and     cognitive outcomes. Results of this research will ultimately lead to future investigations     that assess new interventions and corresponding changes in current standards of care for     children with CFM.   "
81095|NCT02224469|"     In this study a new means of communication for people with locked-in syndrome will be tested.     The investigators will record brain signals directly from the surface of the brain by means     of a completely implantable system. These brain signals are fed wirelessly into an assistive     technology device and will control this device for communication and environmental control at     the users home.   "
81080|NCT02224664|"     This study will be an open label, dose escalation study to investigate the safety,     tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses     given over 21 days (Day 3 to Day 23) to sequential cohorts of subjects with Parkinson's     disease. Each cohort will have 2 study periods. For each cohort, subjects will enter Period 1     and if they meet criteria, approximately 12 subjects will be enrolled into Period 2 and dosed     with PF 06649751. Based on results observed in a previous study, Cohorts 1 and 2 will not be     conducted. Cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg QD. Doses may be     modified based on emerging safety, tolerability and PK data, but the maximum daily dose that     will be given in any cohort will have PK predictions at steady state that are anticipated to     be below toxicokinetic limits. An option for down titration to the previous dose level is     available should the investigator consider that an AE is intolerable. Following down     titration, a single up titration to the next dose level may be attempted if the subject     remains symptom free for at least 48 hrs. Safety, tolerability and PK data of Cohort 3 will     be reviewed prior to initiating the dosing in Cohorts 4 and 5. Available safety, tolerability     and PK data up to Day 24 of at least 5 subjects from Cohorts 4 will be reviewed prior to     initiating the dosing in Cohort 6.   "
81081|NCT02224651|"     This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals     are to assess the safety, tolerability and blood levels of ascending doses of multiple     formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on     exposure, in healthy subjects.   "
81082|NCT02224638|"     Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer     wounds   "
81083|NCT02224625|"     Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product     applied to see if they become sensitized to repeated applications.   "
81084|NCT02224612|"     Compare the fit of two pediatric face masks in children.   "
81085|NCT02224599|"     Patients diagnosed with progressive and/or refractory solid malignancies (SM), who have     failed conventional therapy, and have no available, potentially curative therapeutic options,     will be candidates for this Phase I/II study. Following confirmation of disease progression     and/or refractoriness, eligible patients who agree to participate and sign a consent form     will have their tumor cells/tissues and/or blood analyzed for the expression of a specific     panel of Tumor Associated Peptide Antigens (TAPAs), including Sp17, ropporin, AKAP-4, PTTG1,     Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1.   "
81102|NCT02224378|"     Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and     cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central     venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac     surgery in patients with sinus rhythm, and was speculated to be of value in patients with     rhythm other than sinus. The aim of this study is to assess the predictability of     PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume     index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular     heart surgery.   "
81086|NCT02224586|"     It is just an observation study. The investigates want to explore the signal changes of     resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice     infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin     labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of     ASL is cerebral blood flow (CBF).      The investigates assume that the children with jaundice after light therapy, ALFF and CBF     will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were     proved to be abnormal in MRI T1, T2 structure signal in kernicterus.      Doctors observe the status of infants aside.Using monitoring probe can see clearly.   "
81087|NCT02224573|"     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children     and young adults with Dravet or Lennox-Gastaut syndromes.   "
81088|NCT02224560|"     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in subjects     with Lennox-Gastaut syndrome.   "
81089|NCT02224547|"     The purpose of this study is to perform prospective data analysis on tumor response in terms     of local tumor control after 2 years, potential acute and late toxicity and survival in     patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are     medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens     used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a     risk-adapted approach.   "
81090|NCT02224534|"     The purpose of the study is to evaluate the novel role of ticagrelor to improve long-term LV     remodeling following ST-segment elevation myocardial infarction.   "
81091|NCT02224521|"     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that reduces     inflammation in cells.      This study will evaluate three capsule and two tablet formulations to select the optimal     formulation for further development. Safety will be assessed through clinical laboratory     testing, 12-lead electrocardiogram (ECG), vital signs and Adverse Event/ Serious Adverse     Event (AE/ SAE) recording.   "
81092|NCT02224508|"     Background: Sixty million American adults suffer from moderate to severe chronic pain. Of     these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for     chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This     necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a     large nonprofit health plan, developed and implemented opioid risk reduction strategies for     doctors and patients in some, but not all, of its clinics. The risk reduction initiative     achieved large opioid dose reductions, near universal documentation of care plans, and marked     increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the     opioid risk reduction initiative, incorporating patient perspectives, is needed to guide     health care improvement efforts to reduce opioid risks regionally and nationally.      Research goal: The investigators will evaluate a major health plan initiative to reduce risks     of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced     prescribing of high opioid doses. In 2010 the same clinics increased care planning and     monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects     of this initiative on health and safety outcomes of COT patients. We will test whether the     initiative influenced pain outcomes; patient-reported opioid benefits and problems; and     opioid-related adverse events.      Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction     initiative among COT patients using opioids long-term. The investigators will compare COT     patients from clinics that implemented the initiative with COT patients from care settings     that did not implement the initiative. The investigators will use survey data to assess     patient-reported outcomes including pain severity, depressive symptoms, and patient     perceptions of opioid benefits and problems, including validated measures of prescription     opioid use disorder. They will interview and compare 800 COT patients using opioids long-term     from clinics that implemented the risk reduction initiative and 800 COT patients from care     settings that did not.      Impact: This research will provide an urgently needed, rigorous evaluation of a major risk     reduction initiative among COT patients. Evaluation results will guide efforts of health     plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic     pain care.   "
81093|NCT02224495|"     Exercise training, as part of cardiac rehabilitation, is effective in improving functional     capacity and quality of life in patients with coronary artery disease. Other cardiovascular     and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal     muscle function, oxidative stress, vascular function, pulmonary circulation,     ischaemia-reperfusion lesion and ventricular remodelling.      However, the benefit of exercise training on systolic and diastolic function is controversial     especially after acute myocardial infarction where no longitudinal study has evaluated     diastolic function using modern echocardiographic parameters.      The hypothesis is that a structured program of exercise training can improve systolic and     diastolic function in patients after myocardial infarction.   "
81096|NCT02224456|"     Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver     disease that predisposes patients to the development of hepatocellular carcinoma (HCC).     Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease     progression. Majority of Chinese patients are infected with genotype B and C HBV, which is     different from Caucasian counterparts. This prospective multi-center cohort open-label study     is designed to investigate the long-term effect of TDF on prevention of HCC and disease     progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB     subjects with advanced liver diseases. The study will enrol 240 subjects.   "
81097|NCT02224443|"     The purpose of this study is to identify the effects of different doses of dexmedetomidine on     postoperative cognitive dysfunction in elderly hypertensive patients   "
81098|NCT02224430|"     This study is dedicated to achieving a better understanding of how to identify patterns that     indicate someone might be at high risk for relapse in schizophrenia or schizoaffective     disorder. The investigators are utilizing smartphone technology along with on body sensors to     achieve this goal. The study will observe participants behavior in their natural environment     for a period of 16 weeks or until a signal of relapse is obtained. Participants will also     complete scales in a clinical research environment biweekly.   "
81099|NCT02224417|"     Type II diabetes is associated with a host of adverse and costly complications, including     heart attacks, strokes, blindness, kidney failure, and severe neuropathy that may result in     amputations. For those with diabetes, glycemic control is essential to minimize complications     but many fail at being sufficiently adherent to their treatment. The investigators propose to     test two incentive-based intervention strategies aimed at improving diabetes outcomes amongst     patients with uncontrolled glycemic levels. The incentives are tied either to processes aimed     at improving blood sugar levels (glucose testing, physical activity and medication adherence)     or directly to the intermediary outcome (blood glucose in the acceptable range). While     process incentives are likely to provide more motivation for treatment adherence, as these     goals may be comparably easier to meet, these incentives only reward intermediary outcomes     and it might be more effective to reward successfully achieving a health outcome directly.   "
81100|NCT02224404|"     The primary objective of this post market clinical follow-up (PMCF) investigation is to     evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure     ulcers (PU).   "
81103|NCT02224365|"     The hypothesis of this study is that the daily consumption of 75 g dried apple powder for     twelve weeks will improve arterial stiffness and blood pressure by improving     endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering     biochemical markers associated with cardiovascular risk and glycemic control compared to a     macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with     prediabetes or type 2 diabetes who are overweight or obese will be included in the study.     After a two-week run-in phase, eligible men and women will be randomly assigned to one of two     treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve     weeks. After an initial telephone screening, all participants will be requested to report to     the study site for their first visit. On the first visit (screening), participants will be     provided with verbal and written explanation of the project. They will then be asked to sign     an informed consent form, followed by measuring fasting glucose levels and a medical history     questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be     performed for medical history, medication use, dietary intake, and physical activity.     Qualified participants will be scheduled for their second visit two weeks later (actual     baseline data collection) and randomly assigned to their treatment group. On the second     (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function     will be measured followed by blood draw and urine collection. Anthropometrics will be     measured. Participants will be provided with their assigned treatment and will receive     standard instructions on how to fill out daily diaries for their treatment, and for food and     physical activity records. Blood pressure, vascular function, blood draw, urine collection,     and anthropometric, body composition, diet, and physical activity assessments will be     repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular     measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled     room in the supine position after an overnight fast and 12 hours after the abstinence of     caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.   "
81104|NCT02224352|"     Background: Over one million patients in the US are estimated to undergo mechanical     ventilation every year, and approximately 300,000 of them fail attempts at weaning. The     morbidity and mortality of these patients is greater than in patients who are successfully     weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation     have the potential to benefit society both in terms of human suffering and cost.      Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by     recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs     relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment     can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during     weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation     are in a catabolic state raises the possibility that strategies designed to produce an early     recruitment, and improve the strength, of the expiratory muscles could improve weaning     outcomes in difficult to wean patients.      The current investigation, which will be conducted in healthy subjects and in ambulatory     patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1     and 2), and in patients who are difficult to wean from mechanical ventilation at RML     Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel     triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular     electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study     the physiological (respiratory) responses to such stimulation in assisting respiration in     healthy subjects, in ambulatory patients with COPD and in patients requiring pronged     mechanical ventilation.   "
81111|NCT02224261|"     Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in     improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized     single-blinded controlled trial. Follow-up: five physical therapy assessments:     pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention.     Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing     unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in     Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two     groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy     composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific     thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in     conjunction with progressive active and action-assisted arm exercises; Control group:     progressive active and action-assisted arm exercises. 9 physical therapy sessions.   "
81105|NCT02224339|"     Hypothesis: Identification of vulnerable atherosclerotic plaques (with or without     neovascularization) using carotid CEUS is an independent predictor of MACE (over clinical     risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle     tracking strain indices).      Primary Aims:        1. Evaluate the diagnostic role of carotid CEUS and two-dimensional speckle tracking strain          imaging for detection of carotid plaque:             -  To determine the feasibility and safety of Carotid CEUS and Two-dimensional speckle               tracking strain imaging SE .             -  To determine if carotid CEUS and two-dimensional speckle tracking strain imaging               findings are associated with coronary angiographic results in those patients               undergoing clinically indicated cardiac catheterization.             -  To determine the diagnostic accuracy of CEUS in identifying a vulnerable               atherosclerotic plaque and neovascularization compared to carotid MRI, in a subset               of patients.        2. Evaluate the prognostic role of carotid CEUS and two-dimensional speckle tracking strain          imaging for prediction of MACE:             -  To determine if plaque identification (with or without neovascularization) on               Carotid CEUS SE can improve the overall prediction of MACE over stress echo results               alone             -  To determine if Carotid ultrasound two-dimensional speckle tracking strain indices               can improve the overall prediction of MACE over stress echo results alone.             -  To determine if the detection of plaque neovascularization by Carotid CEUS is an               independent predictor of MACE (over clinical risk factors, stress echo wall motion               results, and carotid ultrasound two-dimensional speckle tracking strain indices).   "
81106|NCT02224326|"     In its long preclinical course, AD shows a spreading pattern of specific pathology in a     uniform sequence of predictable steps including brainstem nuclei in early stages. Many of     these nuclei which are early involved in AD take equally part in the afferences of the Xth     cranial nerve, the Vagus nerve. A method for the functional assessment of Vagus-related     nuclei in the lower brainstem is the technique of somatosensory evoked potentials of the     Vagus nerve (VSEP). This method targets the accessibility of early functional changes by     evoked potentials on one hand and the early affection of specific brainstem nuclei comprising     Vagus afferences in the course of AD on the other hand. The method of VSEP takes advantage of     the transcutaneous stimulation of the auricular branch of the Vagus nerve (ABVN) which is     presumed to be the only sensory part of this nerve innervating parts of the outer meatus     acoustics at the tragus. This cutaneous branch was shown to gain access to Vagus afferences     via brainstem regions which are affected in the course of AD. VSEP latencies in AD were shown     to be significantly longer as compared to healthy controls. Yet, if VSEP really are suited     for the early detection of AD is still not known.      Functional near-infrared spectroscopy (fNIRS) measures changes in cerebral oxygenation by     means of near-infrared light using wavelengths of 650-850 nm. The principle of fNIRS is based     on the principle that regional neuronal activation of the brain leads to an increase in     metabolism and oxygenation of brain tissue in that region which is accompanied by an elevated     regional cerebral blood flow. In AD, there is a growing body of literature reporting deviant     fNIRS activation patterns for a variety of tasks. For example, it was shown that the fNIRS     activation pattern in frontal and parietal cortex areas in subjects with AD performing the     line orientation paradigm is clearly different from healthy controls. Yet, if fNIRS is suited     as a means of early detection of AD is not known.      Therefore we aimed at testing the predictive value of VSEP and fNIRS in the early detection     of AD. The hypothesis to be tested within this study states that subjects developing AD or     MCI within an observation period of 6 years depict longer VSEP latencies, a different fNIRS     oxygenation pattern and a lower performance in neuropsychologic rating below the level of     dementia at baseline than those who remain cognitively stable.   "
81107|NCT02224313|"     The purpose of this study is to compare the vaginal health between premenopausal and     postmenopausal women before and after using oral estradiol for 14 days then estradiol and     progesterone for 14 days.   "
81108|NCT02224300|"     Aims are:        -  develop an Internet-based education programme about venous leg ulcer nursing care (ELC)        -  evaluate the clinical, cognitive and economical outcomes of education programme      Research questions are:      1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg     ulcer nursing care, theoretical knowledge level and practical knowledge)?      Hypotheses for research question 1 are:        1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical          knowledge) than those who will not use the ELC.        2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing          care than those who will not use the ELC.      2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?      Hypotheses for research question 2 are:        1. Ulcer healing progresses better among patients who are taken care by nurses using the          ELC.        2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.        3. Nurses using the ELC will use mire adequate treatment supplies than those who will not          use the ELC.      3. What are the economical outcomes (treatment time and supply usage) of ELC?      Hypothesis for research question 3 is:      1. The economical expenditures will be lower among nurses using the ELC.      The ultimate aim is to promote evidence-based nursing care among patients with venous leg     ulcer.   "
81109|NCT02224287|"     This is a prospective randomized trial to study the effect of assigning the control of the     fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist.     Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose     parameters (cumulative absorbed dose and dose area product). From exposure data, entrance     skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in     this study will be total fluoroscopy time for the procedure. A secondary outcome will be the     ESD. The investigators will further analyze the contribution of clinical predictors (e.g.     stone size/location) and procedural predictors on fluoroscopy times and ESD.      It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating     surgeon is controlling the activation of the x-ray beam.   "
81110|NCT02224274|"     There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid     (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after     cardiac arrest as in normothermic patients. The reasons for this are probably slower     gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take     action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we     expect its effect to be good even in patients with therapeutic hypothermia after cardiac     arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous     coronary intervention will be randomised into two groups. One will be treated with ASA and     clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and     2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be     measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups     will be analysed.      Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with     clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia     and percutaneous coronary intervention (PCI).   "
84363|NCT02181777|"     The purpose of this study is to assess the feasibility of a social skills training group for     people with psychosis.   "
81113|NCT02224235|"     Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate     COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography     (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting     stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one     week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual     anti-platelet therapy (DAPT) for at least 6 months followed by aspirin.      After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3).     Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent     procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month     follow up.   "
81114|NCT02224222|"     The purpose of this study is to assess the impact of frailty as a multidimensional risk     factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining     patient frailty a multimodal questionnaire has been developed including measurement of     psychological, socioeconomical, neurological and behavioral aspects. This study also features     an investigation of the possible relationship between sudden regional weather changes,     individual meteorological susceptibility of the patients and the outcomes of adult cardiac     and vascular surgery.   "
81115|NCT02224209|"     The purpose of this study is to evaluate the efficacy and safety of staged carotid     angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with     carotid artery stenosis at high hyperperfusion risk in peri-procedural period.   "
81116|NCT02224196|"     Comparison of peak airway pressure and gastric insufflation in manual ventilation and     pressure-controlled ventilation with facemask during anesthesia induction in children.   "
81131|NCT02224001|"     For achieving the desired refinements in Asian patients, sufficient septal cartilage must be     needed for the ieal tip projection and lengthening of the nose by the septal extension graft,     columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many     cases having insufficient septal cartilages in Asian augmentation rhinoplasty.      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut     complex in a flag-like shape : using only the septal cartilage as an elongated columellar     septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the     elongated columellar septal strut graft without the septal extension graft to achieve the     desired the result.   "
81139|NCT02223897|"     Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after     orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment     for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal     stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions     after liver transplantation.   "
81275|NCT02222116|"     The objective is to demonstrate that the Flow Area within a blocked coronary vessel as     assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent     (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. The study     hypothesis is that end of procedure flow area is greater with the MGuard Prime compared with     stenting with a non-mesh DES or BMS.   "
81117|NCT02224183|"     Chronic low back pain (cLBP) is the most common pain condition in the military, causing     substantial physical and psychological suffering, reduction in force readiness, and high     economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting     it may be effective in reducing pain intensity, improving back-related function, and lowering     pain medication use. Multiple differences exist between civilian and military populations     with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This     study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military     personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha     yoga classes, supplemented with home practice, compared to an education group. Additionally,     the enormous mental health burden often shouldered by returning military personnel presents     another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's     capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the     cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the     provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to     evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT     will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans     populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home     practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP     and psychological comorbidities. These results will help determine whether yoga is an     effective modality for addressing cLBP in a Veteran population.   "
81118|NCT02224170|"     The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on     postoperative quality of recovery after laparoscopic cholecystectomy   "
81119|NCT02224157|"     The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is     effective in treating asthma when used 'as needed' in patients with milder asthma. The     efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler     twice daily plus terbutaline Turbuhaler 'as needed'   "
81120|NCT02224144|"     The purpose of this study is to test whether active vitamin D (calcitriol) protects bones     from weakening and protects blood vessels from calcium deposits over the first year of kidney     transplantation.   "
81121|NCT02224131|"     Patients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring     offers the opportunity to improve outcomes of intracranial aneurysm patients undergoing stent     deployment by individualizing therapy.This trial is designed to demonstrate the superiority     of a strategy of platelet function monitoring with dose adjustment in suboptimal responders     as compared to a more conventional strategy without monitoring and without dose adjustment to     reduce the primary end point evaluated 6 months after stent deployment in patients with     intracranial aneurysms.   "
81122|NCT02224118|"     The purpose of this study is to investigate the safety (adverse events, weight, blood     pressure, pulse rate, body temperature, abdominal ultrasonography, standard 12-lead     electrocardiography, and laboratory tests) of CNTO 3649 when administered once by     subcutaneous injection in healthy adult Japanese men or once a week for 4 weeks in Japanese     participants with type 2 diabetes mellitus (disorder in which there is decreased insulin in     the body or the body's insulin is not effective, resulting in high blood sugar, increased     thirst and urine, and many other side effects).   "
81123|NCT02224105|"     The general aim of the current study was to investigate the safety and tolerability, and     pharmacodynamics (endotoxin-induced inflammatory response of a single intravenous bolus     administration of 2 ng/kg body weight Escherichia coli lipopolysaccharide (LPS)) of BI 653048     BS H3PO4 capsules in healthy male subjects following oral administration of multiple rising     doses of 25 mg to 200 mg over three days compared to the active comparator prednisolone and     placebo.      Pharmacodynamics were assessed by investigating the influence of LPS administration on     inflammatory parameters. More specifically, it was evaluated whether and to what extent the     symptoms induced by LPS challenge can be attenuated by ascending BI 653048 BS H3PO4 doses     using prednisolone as positive control and placebo as negative control. A secondary objective     was the exploration of pharmacokinetics of BI 653048 BS, the investigation of other     pharmacodynamic parameters (biomarker) and of the tolerability of LPS.   "
81124|NCT02224092|"     The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin     multimineral with phytonutrient product vs. placebo on heart health risk factors following     twice-daily consumption for eight weeks; (2) To test the safety and tolerability of the     multivitamin multimineral with phytonutrient product vs. placebo following twice-daily     consumption for eight weeks.   "
81125|NCT02224079|"     Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.)     doses of BIIB 722 CL   "
81126|NCT02224066|"     A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected     for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated     previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and     Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet     reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus     DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following     TAVI.   "
81127|NCT02224053|"     This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of     AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will     receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in     Period 2. The dose of AZD9291 in Period 1 and the dose of AZD9291 in Period 2 will be     separated by a washout of at least 21 days (the washout will not be more than 5 weeks). The     study will be performed at up to 2 sites in the USA and will assess the effect of omeprazole     (proton pump inhibitor) on AZD9291 exposure   "
81128|NCT02224040|"     The current study goal is to examine the effect of Cephalosporins, Azithromycin and the     combination of both on typhoid fever therapy in endemic population.      The investigator's hypothesize that the combination of azithromycin and ceftriaxone may prove     superior to each drug, ceftriaxone or azithromycin, alone.   "
81129|NCT02224027|"     The use of laryngeal mask airway or i-gel to manage airway may improve success rates,     especially in difficult situations more than tracheal intubation.   "
81130|NCT02224014|"     Study to investigate the safety and the efficacy in patients with insomnia, receiving     Lendormin D tablet under condition of normal clinical practice.   "
81132|NCT02223988|"     Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks     of morbidity and mortality for patients who require mechanical ventilation.      VAP is associated with the contamination and colonization of bacteria in the lower airway.     These bacteria may be present in the lower airway by the aspiration of oropharyngeal     secretions. Therefore limiting the amount of secretions that pass the glottis and enter the     airway is paramount.      Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to     manage breathing. These tubes may have a distal cuff which sits within the trachea. When the     cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube     thereby limiting the amount of secretions entering the lower airway. These secretions may     leak around the cuff and cause tracheobronchial colonization. It has been shown that removal     of secretions that pool above the cuff via dorsal lumen suction leads to a decreased     incidence of VAP.      The purpose of this study is to measure the effect of suction above the cuff tracheostomy     tubes related to VAP incidence   "
81133|NCT02223975|"     Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval skin     disorders are common and the diagnosis of these conditions can be difficult. Reliable     discrimination between benign vulval skin conditions, precancerous conditions or vulval     cancer often requires tissue biopsies. In addition the monitoring of patients with vulval     disease at risk cancerous change is currently limited to visual assessment often supplemented     by multiple invasive tissue biopsies. There are currently no established non invasive tests     available for the diagnosis of vulval skin diseases.      The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform infrared     spectroscopy are non invasive diagnostic tools that use the interaction of light within     tissues to identify the chemical composition of different tissues. The use of these tools may     reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease.      The aim of this project is to explore the use of vibrational spectroscopic techniques in the     diagnosis of vulval skin disease. This will be achieved by performing vibrational     spectroscopy on samples of tissue previously taken from women with vulval skin disease     treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy     will be compared with the routine tests and the accuracy of spectroscopy determined.   "
81134|NCT02223962|"     Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant     a hospitalization. During the hospitalization, patients are extremely physically inactive     with only a limited recovery one month after discharge. Physical inactivity is associated     with negative health benefits. Therefore intervening in the period after and exacerbation     seems useful to improve the levels of physical activity. Physical activity counseling and     real-time feedback have already been applied in stable patients with COPD, with beneficial     effects.The present study will investigate whether this specific intervention will help to     improve the activity level in patients after an acute exacerbation. Further we investigated     the effects of the intervention on improvements in functional exercise capacity.   "
81135|NCT02223949|"     The purpose of this study is to investigate whether mechanical cervical ripening (using the     Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in     overweight and obese women undergoing labor induction.   "
81136|NCT02223936|"     Prospective, multicenter study following for 2 years, 250 children who presented during the     first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of     Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose     pregnancy was normal. Evaluating morbidity, mortality, growth and the neurodevelopment of     each group by a Brunet Lezine scale. Evaluating anxiety and depression in parents of those     children using a scale.   "
81204|NCT02223039|"     This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center     study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The     objectives of this study is to investigate efficacy, safety, tolerability, and     pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients     with moderate to severe chronic plaque psoriasis.   "
81137|NCT02223923|"     This study will investigate the use of a new drug targeting the DNA repair pathway AZD6738,     an ATR inhibitor). Many tumours have lost important DNA repair functions and rely more     heavily on a few remaining repair pathways to survive. Preclinical studies indicate that, in     these tumours, preventing the function of the remaining pathways will lead to tumour cell     death, while sparing normal cells. This study aims to investigate the safety and tolerability     of the new drug in patients with advanced cancer, as well as in combination with palliative     radiotherapy, where the drug may increase the effectiveness of radiotherapy by preventing     repair of the radiationinduced DNA damage. As the drug has only been given to a small number     of patients, the study will focus on safety and finding the correct dose to proceed to     further studies, although preliminary signs of drug activity will also be examined.      The initial part of the study will administer increasing doses of the drug to groups of     patients with advanced cancer who have no standard anticancer treatment options available.     Testing will establish whether the drug levels in the body and tumour are adequate for the     drug to have an effect, and any toxicity will be assessed. After the recommended dose is     established, the recommended dose schedule will be stablished by trialing different     schedules. Participants will be tested to see if their tumours lack the main DNA repair     pathway (those who are predicted to have a better response to this drug). Finally, the drug     will be given to patients with advanced cancer who require a course of radiotherapy for     symptom control - the drug will be tested at different doses and with different doses of     radiotherapy.      Side effects will be monitored and tests will establish whether the drug is enhancing the     radiotherapy effect in the tumours or normal tissues.   "
81138|NCT02223910|"     Background: The technology of brain-computer interfaces (BCI) enables the monitoring of brain     activity and the generation of a real-time output about specific changes in activity     patterns. The recorded subject receives a feedback about the neural activity associated     his/her efforts and can thus learn to voluntarily modulate brain activity. There is     accumulating evidence that training of motor cortex activations with brain-computer interface     systems can enhance recovery in stroke patients. Here we propose a new approach which trains     resting-state correlates of motor performance instead of activations related to movements.     Previous studies have shown that the more resting-state alpha oscillations in the motor     cortex are coherent with the rest of the brain, the better stroke patients perform in motor     tasks. Furthermore, observational studies have suggested that training of alpha-band     coherence in the motor cortex with neurofeedback has beneficial effects on motor performance.      Objective : This randomized controlled study aims to test the usefulness of training     functional connectivity between the motor cortex and the rest of the brain with a     brain-computer interface in patients with chronic stroke. We hypothesized that this network     variant of neurofeedback training will lead to region and frequency specific increases in     functional connectivity and to an improved function of the affected upper extremity.      Methods : 10 patients with chronic stroke and significant unilateral deficit of upper     extremity motor function will perform two periods of neurofeedback training in a randomized     cross-over design. In one period, they will train alpha-band coherence between intact areas     around the affected motor cortex and the rest of the brain. In a control period, they will     train alpha-band coherence between a control region not directly related to motor function     (the medial prefrontal cortex of the healthy hemisphere) and the rest of the brain. In each     period, two training sessions per week will be performed for 4 weeks. The periods are     separated by at least 4 weeks. Oscillations in the brain will be reconstructed from 128 EEG     channels using an adaptive spatial filter and the coherence between the target area and the     rest of the brain will be calculated in real time. Coherence magnitude will be displayed in     the form of a cursor on a computer screen.      Significance: This study may provide causal evidence for a role of functional connectivity in     motor learning and may lead to new strategies for rehabilitation.   "
81140|NCT02223884|"     This is the phase II, single-arm, single-center study assessing the efficacy of weekly     docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or     metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end     point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and     secondary end point includes disease control rate, progression free survival, overall     survival and safety.   "
81141|NCT02223871|"     This was a single-center study using induced blood stage malaria infection to characterize     the activity of ACT-451840 against early Plasmodium falciparum blood stage infection   "
81142|NCT02223858|"     Arthritis is a painful, disabling condition that disproportionately affects African     Americans. Existing arthritis treatments yield only small to moderate improvements in pain     and are not effective at reducing racial disparities in arthritis pain. According to the     biopsychosocial model of pain, there is a need for novel interventions that target     psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence     from the field of psychology suggests that an intervention designed to develop a positive     mindset has the potential to improve pain and functioning and reduce racial disparities in     patients with arthritis. Interventions to foster a positive mindset have been developed for     clinical patient populations but have not yet been fully tested in patients with arthritis or     in Veterans, nor have their effects on racial differences in clinical outcomes been examined.     This study will address these gaps by testing the impact of an evidence-based positive     activities intervention on pain and functioning in African American and White Veterans with     knee arthritis.   "
81143|NCT02223845|"     To investigate whether listening to music at the time of embryo transfer reduces anxiety     levels in women undergoing assisted conception treatment.   "
81144|NCT02223832|"     This is a study to evaluate the relative pharmacokinetic properties and the tolerability and     safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after     single-dose administration.   "
81145|NCT02223819|"     The study is designed to determine the 32 month rate of distant relapse in patients with     uveal melanoma who are at high risk of recurrence following definitive therapy with surgery     or radiation who receive adjuvant crizotinib; and secondarily, the overall survival and     disease specific survival in this patient population.   "
81146|NCT02223806|"     To determine whether there is a difference in effectiveness of routine uterine tonus     assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered     by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal     and neonatal outcomes.   "
81147|NCT02223793|"     The overall goal of the present project is to contribute to new knowledge about the effect of     a low threshold population screening system for cardiovascular risk factors in Norway.     Further, this project aim to study if identifying high cardiovascular risk itself may lead to     beneficial changes in health behaviors such as physical activity, diet, tobacco and alcohol     behavior together with reduced risk score of cardiovascular disease, across socioeconomic     status. This fall, a nationwide, free screening of cardiovascular risk factors will be     conducted in 150 pharmacies in Norway. All participants that consent to participate will     measure full lipid-profile, blood pressure, HbA1c, body weight and height by health care     providers in pharmacies. Based on their measurement levels, participants will be stratified     into either a low or a high risk group. In the high risk group, participants will further be     randomized to either the intervention group or one of the two control groups. Participants in     the intervention group will be informed about all their measurement levels with comparison to     the recommended levels. Contrary, participants randomized to the two control groups will have     delayed information of their measured levels. Participants in the intervention group and the     first control groups will receive general oral and written information about how to lower     their measurement levels in 8 weeks. In the second control group, participants will not     receive any information at the first visit. In this way the investigators may be able to     isolate the effect of identifying high risk and high levels of the risk factors itself. All     groups will be given a diet- and physical activity questionnaire at visit 1, and will be     invited back after 8 weeks to once more perform the measurement screening and receive the     same questionnaire. At visit 2, all participants will, after the measurement screening, be     informed about their measured risk factors and receive information on how to lower their     levels. 1 year after inclusion, all participants in the three groups will be invited back for     a one-year follow up visit in pharmacy.   "
81148|NCT02223780|"     Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment     options, progressive lung disease. Patients with COPD often have only limited access to     palliative care. The goal of this research project is to improve the quality of life of     patients with COPD.      Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain     and depression) are insufficiently alleviated. In addition, often in connection with an     infection, patients frequently suffer from respiratory decompensation; this may lead to     invasive interventions as well as the admission to the emergency room or an intensive care     unit. It may ultimately lead to the death of the patient.      Aim This study aims to show that early palliative care can reduce the number of necessary     invasive interventions and improve the quality of life of patients with COPD. For this     purpose, a group of patients receiving early, standardized palliative care will be compared     to a group of patients receiving customary treatment only, without systematic intervention by     palliative care experts.      Significance The results of this study should make it possible to efficiently use the medical     resources which are required for the appropriate care of patients with COPD. The goal is the     best possible quality of life and better coordination of the measures taken, especially with     regard to the area of acute care and the wishes of the patient.   "
81149|NCT02223767|"     This study investigates the beneficial effects of prefrontal brain stimulation (with a     facilitating TMS protocol) before exposure therapy in acrophobic patients. The two exposure     sessions were realized in virtual reality. Before and after therapy, the phobic symptoms were     measured on a subjective, behavioral and physiological level. The placebo-controlled single     blinded study includes 50 phobic patients, which were randomized into verum or sham TMS.   "
81150|NCT02223754|"     The purpose of this study is to test the performance of an investigational multifocal test     soft contact lens.   "
81151|NCT02223741|"     This study is designed to assess effectiveness, safety and cost-utility of conventional     rehabilitation and traditional Korean medicine conjugated rehabilitation on children with     cerebral palsy.   "
81152|NCT02223728|"     Interventions to help individuals with traumatic brain injury manage their healthy lifestyle     behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a     telehealth lifestyle program on reductions in weight and improvements in health     behaviors/lifestyle choices.   "
81153|NCT02223715|"     The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational     study to characterize patients with CDI as well as to understand treatment and management of     the disease.   "
81154|NCT02223702|"     The objective of this randomized clinical study was to evaluate the effect of systemic     administration of moxifloxacin compared to amoxicillin plus metronidazole combined with     non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in     6-month follow-up.      A total of 40 systemically healthy patients with GAgP will evaluate in this randomized     clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding     on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month.     Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole     and 500 mg amoxicillin per os three times daily for 7 days consecutively.   "
81155|NCT02223689|"     Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.   "
81156|NCT02223676|"     The purpose of this study is to investigate the effect of implementing clinical pharmacists     in the Emergency Department Team at Randers Regional Hospital. The clinical pharmacists     conduct medication history, make medical interaction screenings, -reconciliations and     -reviews on unscheduled patients admitted to the Emergency Department during daytime.   "
81157|NCT02223650|"     The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D)     overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in     children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to     proceed to a full-scale, longer-term randomized trial.   "
81158|NCT02223637|"     The Novartis Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is     stablished to meet a post marketing commitment agreed upon with CBER to prospectively collect     data on pregnancy exposures to Novartis Meningococcal quadrivalent CRM-197 conjugate vaccine.      It is an observational study of women inadvertently immunized with the Novartis Meningococcal     quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time     during pregnancy as part of routine care.      The objective of the pregnancy registry is to evaluate pregnancy outcomes among women     immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior     to conception or at any time during pregnancy. The primary outcomes of interest include major     congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will     be collected, including spontaneous abortions and stillbirths.   "
81159|NCT02223624|"     Many studies have shown that exercise training is beneficial for patients with chronic heart     failure (CHF). Heart Foundation guidelines strongly recommend regular physical activity and     referral to a specifically designed rehabilitation program for all patients with CHF who are     medically stable. Such programs usually comprise aerobic exercises such as walking, and light     weightlifting with care to avoid heavy straining due to stress that this may place on the     heart.      Eccentric contractions are those in which the muscle lengthens as it contracts. Exercise     involving eccentric contractions is known to increase muscle strength and this type of     exercise also requires less oxygen. This is because it requires less power to resist lowering     a weight than it does to lift a weight. Initial evidence suggests that this form of exercise     has favourable outcomes in the frail elderly and those with chronic disease.      This study aims to determine if eccentric exercise can be applied to patients with heart     failure to increase their physical function while using less energy so that exercise is more     tolerable for patients who complain of significant breathlessness and fatigue. This study     also aims to determine if eccentric exercise is a safe alternative exercise option for     patients at risk of negative events.      The investigators propose to run a randomised controlled trial. Eccentric exercise will be     delivered to a group of heart failure patients referred to the existing heart failure     rehabilitation program at the Northern Hospital. The program will consist of eight weeks of     twice weekly exercise of one hour's duration comprising eccentric exercise combined with     walking and light weight training. This will be compared to a group of patients participating     in the current exercise program consisting of light weightlifting and aerobic exercises for     the same length and duration of exercise and also to a third group of patients who will be     wait listed for 8 weeks. Following the completion of the eight week waiting period, these     patients will be offered the option of joining the standard exercise program.      The investigators expect that the eccentric exercise group will have improved walking     capacity and quality of life compared with the traditional program and the wait-list control     group. It is also possible that there is no difference between the eccentric and traditional     program in terms of functional outcomes but that the participants report that eccentric     exercise is easier.   "
81160|NCT02223611|"     The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in     stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate     the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer     patients after the complete resection.   "
81162|NCT02223585|"     Gut microbiota are involved in the regulation of mammalian metabolic pathways through     host-microbiota metabolic, signaling, and immune-inflammatory interactions that     physiologically connect the gut, liver, brain, and other organs. Correlation of these     metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe     relationships.      Microbiome sequencing have generated novel insights into the role of gut microbial     composition in health and disease, but are limited in addressing the microbial contribution     to host metabolism and the gut microbial dysbiosis in disease.      This is an exploratory trial, aiming to examine how gut microbial conditions determine     response to dietary challenge by measuring urine, plasma and stool metabolites resulting from     metabolism of protein, polyamines and bile acids in combination with stool bacterial     composition. The focus of this trial is to evaluate impact of protein based food challenges,     based on cross-over design of two diet challenges of animal and vegan protein sources.   "
81163|NCT02223572|"     Due to its prevalence worldwide, osteoporosis is considered a serious public health concern.     The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US     only.      Hip fracture is associated with serious disability and excess mortality. Studies have shown     that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased     risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already     sustained a fracture in the past 4 years (In average). These data indicate the major     opportunity afforded by secondary fracture prevention strategies.      By responding to the first fracture, we can reduce the incidence of second and subsequent     fractures. However, even after longer medical follow-up according to regular standard of     care, medical treatment and rehabilitation, the medical system has been unable to translate     the eminent risk into an effective preventive treatment.   "
81183|NCT02223312|"     The purpose of this study is to evaluate the safety and effectiveness of Tumor Associated     Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of progressive     and/or refractory hematologic malignancies (HM). We hypothesize that treatment of patients     with relapsed and/or refractory HM, without available potentially curative treatment options,     and whose neoplastic cells express at least one (1) TAPA of a defined panel of TAPAs, using     low-dose cyclophosphamide (CYP) followed by an autologous, monocyte-derived, TAPA-pulsed DC     vaccine and low-dose granulocyte macrophage colony stimulating factor (GM-CSF), will result     in TAPA-specific T-cell responses without significant toxicities. We also hypothesize CD4+     T-cell and CD8+ T-cell responses generated against specific TAPAs may translate into clinical     antitumor activity.   "
81164|NCT02223559|"     The assessment of pulmonary artery pressure (PAP) and parameters describing right ventricular     function stand in the focus of the diagnosis and clinical management of pulmonary     hypertension (PH). Right heart catheterization (RHC) is the gold standard method to measure     PAP and to provide hemodynamic information on right ventricular function. However, due to its     invasive nature, RHC is not optimal for screening and for close monitoring of the disease.     Therefore, the development of non-invasive methods providing reliable PAP measurements and     right ventricular functional parameters would be of major benefit.      Today, the most often used comprehensive non-invasive method for these purposes is     echocardiography. However, the method has limitations; in many cases PAP is significantly     under- or overestimated - especially in subjects with co-existing pulmonary diseases.     Regarding right ventricular function, although novel echocardiography parameters appear to be     promising, they have not yet been evaluated in all forms of PH.      Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is     considered to be as gold standard for the non-invasive assessment of right ventricular     function. In addition, our group showed that with a special approach (vortex method), MRI     enables the determination of PAP with physiologic accuracy, but the method has not yet been     validated systematically in different forms of PH.      All patients undergoing right heart catheterization in our clinic are candidates for the     study. Excluded will be patients not eligible for MRI or declining to take part in the study.     MRI and Echocardiography will be performed within two weeks of the RHC.      Hypothesis:        1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad          collective of patients with PH of diverse ethology.        2. MRI derived right ventricular functional parameters correlate better to invasive          measurements and to established prognostic parameters than echocardiography derived          right ventricular functional parameters.        3. Novel right ventricular tissue Doppler parameters add substantially to classical          echocardiography parameters to describe right ventricular function.   "
81165|NCT02223546|"     Choroidal volume measured fluctuates significantly over a 24 hour time frame.   "
81166|NCT02223533|"     Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan     can help control postoperative pain. Placing a wound catheter intraoperatively following     colon surgery could optimize the control of acute pain with less consumption of opioids and     few adverse effects.      Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo     laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital.      Patients were recruited and randomly allocated to wound catheter placement plus standard     postoperative analgesia or standard postoperative analgesia alone. A physician from the acute     pain management unit monitored all patients for at multiple points over the first 48 hours     after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and     amount of intravenous morphine used via patient controlled infusion.   "
81167|NCT02223520|"     This trial will test the hypothesis that treating parents of neonates requiring NICU care     with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S.     aureus from parents to their neonates.   "
81168|NCT02223507|"     The objective of the present study was to obtain information about the safety, tolerability     and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two     increasing doses in healthy elderly volunteers, following the infusion schema of a loading     dose (1 hour) and a maintenance dose (5 hours)   "
81169|NCT02223494|"     Study to assess the safety of terbogrel during open-label, long-term treatment in medically     stable or improving patients with primary pulmonary hypertension who have completed the     12-week, double-blind randomized trial of terbogrel (protocol 528.19)   "
81170|NCT02223481|"     This study sought to determine whether terbogrel was an effective treatment for primary     pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.   "
81171|NCT02223468|"     The microbiota represents the collections of microbial communities that colonize a host. In     health, the microbiota protects against pathogens and maturation of the immune system. In     return, the immune system determines the composition of the microbiota. Altered microbial     composition (dysbiosis) has been correlated with a number of diseases in humans. The real     role of the microbiota in transplant recipients is still unknown even though we suspect that     it may be affected directly or indirectly by immunosuppressive drugs and antimicrobial     prophylaxis taken by transplant patients, as well as by inflammatory process secondary to     ischemia/reperfusion injury.      A number of studies have investigated the impact of liver transplantation on the intestinal     microbiota. In a recent analysis of stool flora (Microb Ecol 2013; 65: 781-791) in 12 liver     transplant recipients, changes in the microbiota were correlated to post-transplant     infections. The authors suggested that the shift to pathogenic strains of bacteria due to the     use of prophylactic antibiotics may be contributing to post-transplant complications. In a     larger study, Wu et al (Hepatobiliary Pancreat Dis Int 2012; 11: 40-50) demonstrated marked     changes in the gut microbiota post-transplantation with an increase in Enterobacteriaceae and     Enterococcus, and reduction in Eubacteria, Bifidobacterium and Lactobacillus species. These     changes, however, resolved over time such that by 6 months, at times when bacterial     prophylaxis ends and immunosuppression is reduced.      A better characterization of the impact of post-transplant therapy on the human microbiota     has the potential to improve our understanding of the infection process and translate into     development of new therapeutic strategies.      The main goal of this study is to characterize intestinal microbiota and confirm the same     bacterial DNA in peripheral blood and portal lymph nodes in patients affected with end-stage     chronic liver disease, and to analyze its evolution from the moment of inclusion in waiting     list throughout the first year after liver transplantation. For each patient, a healthy     CONTROL with a similar age (± 10 years) will be selected from the same family setting, in     whom just one sample will be obtained during the enrollment phase.      The second goal is to analyze the potential associations between microbiota flora and     transplant outcomes during the same period.   "
81205|NCT02223026|"     Study to investigate the effect of food on the relative bioavailability of a 2.5 mg     linagliptin+1000 mg metformin fixed dose combination (FDC) tablet   "
81172|NCT02223455|"     Hand hygiene is the single most effective practice in preventing the spread of     hospital-acquired infections. Despite the strength of the evidence, hospital staff continue     to sanitize their hands less than half of the time required by guidelines. Effective     interventions are needed to improve hand hygiene compliance rates among hospital staff, but     most are of poor quality and do not examine the specific effects of individual interventions.     This study will build a bundle of three hand hygiene interventions using a research design     that allows for the effectiveness of each intervention to be measured individually and     combined.   "
81173|NCT02223442|"     Chronic pain is defined as pain that persists after healing of the wound that caused it, and     can occur even in the absence of any obvious pathological trigger. In our country, there is a     growing interest in the proper management of the disease pain.      Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease     and from 75% to 90% of patients with advanced cancer suffers from chronic pain .      However, pain management is mostly inadequate. This study aims to assess the Italian clinical     practice in reference to the pharmacological management of chronic pain by health     professionals involved in the treatment of pain in some centers belonging to the Italian     network of pain therapy.   "
81184|NCT02223299|"     The purpose of this study is to determine if adding over the counter nutritional supplements     will have a benefit to participants currently taking prescribed antidepressants who have not     experienced complete remission of their depression symptoms.   "
81463|NCT02219672|"     This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection     phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese     patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii     on HIV-1 reservoir.   "
81174|NCT02223429|"     The overall goal of this project is to identify the genetic, hormonal, and neurobiological     influences on paternal nurturing behavior and to determine if fathers' neural responses to     infants can be modulated by neuropeptides known to play a role in parenting in experimental     animal models.      The aim is to determine if pharmacological manipulation of central oxytocin (OT) and     vasopressin (AVP) levels influences the neural response to viewing pictures of one's own     infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old     children will be scanned on two separate occasions; once under the influence of OT/AVP and     once under the influence of placebo. Fathers will be randomized to either OT or AVP, and     order of administration of drug and placebo will counterbalanced across subjects. Fathers     will be scanned while viewing pictures of their own and an unknown child and while listening     to unknown infant cry stimuli.      The investigators hypothesize:        -  OT will augment the ventral tegmental area (VTA), ventral striatum and medial          orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will          augment the primary auditory cortex (AI) response of fathers to infant cries.        -  AVP will augment the lateral septum response to viewing own child pictures.   "
81175|NCT02223416|"     Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in     healthy female volunteers.   "
81176|NCT02223403|"     Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and     submaximal exercise performance in healthy adults. Investigation for similar effects in     patients with heart failure has not previously been conducted.      This was a randomized, double-blind, placebo controlled trial. Following ingestion of the     active agent or placebo, subjects with systolic heart failure underwent submaximal steady     state exercise with gas exchange analysis followed thirty minutes later by a six minute walk     test. Second testing sessions were performed ten days.      There were no significant differences in the treatment and placebo arms in average oxygen     consumption or six minute walk distance.      In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich     beetroot juice concentrate, there is no significant difference with regard to oxygen     consumption during submaximal steady state exercise or six minute walk testing distance.      Further study is warranted to determine the true efficacy of nitrate consumption in this     population with adjustments in acute or chronic dosing, exercise duration, or intensity.   "
81177|NCT02223390|"     In this study, the investigators propose to develop Improving AIDS Care after Trauma     (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment     for traumatic stress. The intervention will target women in South Africa who have histories     of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce     avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.   "
81178|NCT02223377|"     Currently nearly 70% or more surgeries are being done as ambulatory (day care) procedures as     they offer significant benefit to the patients as well as to the hospitals. Inadequate pain     relief (30%-40%) and nausea-vomiting form the leading factors affecting the quality of care     and hence its efficiency. Opioids form the primary modality to treat moderate to severe pain,     but can also cause significant nausea-vomiting and other side effects. Although hydromorphone     is five times more potent than morphine, in equianalgesic doses they both could provide     similar pain relief. They both exert no ceiling effect for their analgesia, and hence     incomplete or inadequate analgesia is related to the appearance of side effects. In this     study the investigators shall assess the proportion of patients who satisfy the outcome of     'satisfactory analgesia with minimal nausea-vomiting' in ambulatory surgeries, assessed at 2     hours after surgery. Patients would be randomized to receive either morphine or hydromorphone     in the surgical recovery area. All personnel involved with the study would be blinded. The     investigators will also look to assess the time to discharge and other side effects. This     will help to choose the better drug, thereby improving pain relief and side effects, and also     the efficiency of health care delivery.   "
81180|NCT02223351|"     ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to     contracting other infections because of their compromised immune system. As HIV patients will     be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one     of the drugs that is commonly prescribed to HIV patients (ritonovir).   "
81206|NCT02223013|"     Comparative pharmacokinetics and tolerability of two experimental extended release     formulations and a standard formulation of BIBV 308 SE following multiple doses.   "
81207|NCT02223000|"     Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral     solution of BIBV 308 SE following multiple doses, tolerability   "
81181|NCT02223338|"     1. Background: Over 1 million intravitreal injections are performed annually in the United          States. The most devastating complication related to these injections is          endophthalmitis, with an incidence of 0.02 - 0.1% per injection. Techniques aimed at          prevention of this complication have been studied, though emergence rates of antibiotic          resistant bacteria in a single clinic population comparing antiseptic technique with          iodine vs. use of post-injection second generation fluoroquinolones has not been          reported in the literature.        2. Objectives: The purpose of the study is to help determine the best way to prevent          infection and limit antibiotic resistance in patients receiving eye injections.        3. Procedures Involved (Research Interventions): After the patient is chosen based on          inclusion criteria and agrees to participate in the study, exclusion criteria will be          reviewed, cognizance will be determined, informed consent and HIPAA compliance forms          will be signed. At this point and prior to the instillation of ophthalmic medications, a          Rayon swab will be passed along the inferior fornix of the study eye while the patient          looks up and the examiner lowers the lower eyelid. The swab will then be used to          inoculate chocolate agar and a blood agar culture plates and a glass slide. These will          be brought to the FMO microbiology department for culture and Gram stain. All          Staphylococcus aureus and coagulase negative Staphylococcus species identified will be          subjected to sensitivity testing using the Gram Positive antibiotic panel available at          Loma Linda, with the addition of ciprofloxacin.   "
81182|NCT02223325|"     -  To compare the prognosis of acute pancreatitis between geriatric and other adult          patients        -  To evaluate the efficacy of various prognostic scores in geriatric patients with acute          pancreatitis   "
81185|NCT02223286|"     The purpose of this study is to understand the use of Corus® CAD in the clinical decision     making process of patients who underwent the evaluation of chest pain or anginal equivalent     symptoms. Specifically, to better understand whether the use of the assay in clinical     decision making resulted in changes in noninvasive diagnostic test ordering or diagnostic     yield of additional tests ordered and/or invasive angiography.   "
81186|NCT02223273|"     Phase 1: An observational study ( registry) will be conducted with the objective of     documenting the practice of stroke treatment in brazilian and latin american hospitals.      Phase 2: A cluster randomized trial aiming to evaluate the effect of a multifaceted strategy     to increase evidence based treatments usage for stroke patients. The hospitals will be     randomized into two groups: the multifaceted strategy group and the usual care group.   "
81187|NCT02223260|"     The aim of the study is to investigate the safety and tolerability of dabigatran etexilate     solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to     older children and adults and to confirm dabigatran etexilate dosing algorithm for children     aged less than 1 year.   "
81188|NCT02223247|"     This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced     stage solid malignant tumors. This research is being done to find out how safe and useful     TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy     exists that would be curative or might provide significant benefit. TVB-2640 belongs to a     class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they     interfere with the body's (and the tumor's) ability to use a substance called fatty acid     synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.   "
81189|NCT02223234|"     The overall objective of the proposed study is to test, among Canadian families, the     comparative effectiveness of 2 different versions (doses) of a family-based obesity     prevention intervention that is tailored to families' behavioural risk profile.      To achieve this objective, we will conduct a randomized controlled trial of families with     children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1)     Monthly emails with general health information (Attention Control), 2) Tailored weekly emails     and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home     visits (Email +4). The intervention will last 6 months, with follow-up at 12-months     post-intervention (18 months from baseline). We will examine the impact of the intervention     on the children's body composition, weight-related behaviours, and biomarkers of diabetes and     cardiovascular disease risk.      We hypothesize that, compared to children in the Attention Control, children in the Email +2     and Email +4 conditions will achieve:        1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass          index (BMI),over a 6-month intervention period.        2. higher frequency of family meals, child's sleep duration, physical activity, and fruit          and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary          behaviour over a 6-month intervention period. (secondary outcomes)        3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting          insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein,          trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a          6-month intervention period.      We further hypothesize that there will be no significant difference in these outcomes between     children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.   "
81203|NCT02223052|"     This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of     2 phases:      Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics     (Food Effect) with an Extension      This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with     hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that     have originated or metastasized to the liver for which no standard treatment exists or have     progressed or recurred following prior therapy. Subjects must not be eligible for therapy of     higher curative potential where an alternative treatment has been shown to prolong survival     in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate     in this study.   "
81208|NCT02222987|"     Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100     mg terbogrel bid.   "
81190|NCT02223221|"     Recurrent pregnancy loss (RPL) is a multifactorial disorder which affects about 1% of all     couples and challenges both patients and clinicians technically and emotionally. IVF clinics     see higher prevalence of RPL, since many RPL patients are seeking for assist reproduction     treatment with or without other infertile factors. Guidelines for evaluation and treatment of     RPL patients include screening for uterine abnormalities, parental chromosomes, autoimmune     antibodies and cure gynecological infections, but there are still half of RPL patients remain     unexplained.      The documented high incidence of chromosomal errors in first-trimester miscarriages and an     increased rate of aneuploidy in patients with RPL has led to the theory that screening     embryos before implantation for aneuploidy may decrease the risk of a subsequent loss and     serve as a possible treatment. The technology, indications of use, and even terminology for     genetic testing of embryos have greatly changed since the first PGD(pre-implantation genetic     diagnosis) baby was born in 1990. The current best evidence shows blastocyst biopsy followed     by new rapid comprehensive chromosome screening(termed pre-implantation chromosomal screening     or comprehensive chromosome screening, PCS or CCS, or the investigators generally termed PGS)     based on array-comprehensive genome hybridization(aCGH), single nucleotide polymorphism     array(SNP-array) or next generation sequencing(NGS), to be the most powerful technology.     However, for whom this PGS technique is most suitable to achieve improved clinical outcome     have not yet been identified by well defined, ITT based research with carefully selected     control and adequate sample size.      The investigators research is to determine whether in vitro fertilization (IVF)/     intracytoplasmic sperm injection (ICSI) combined with SNP-array based pre-implantation     comprehensive chromosome screening (CCS) will improve the clinical outcome of infertile     female patients with recurrent spontaneous abortion history.   "
81191|NCT02223208|"     This is a multicenter study that includes two phases:        1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to          CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose          escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin          will be used for the subsequent phase II study.        2. A phase II study to evaluate the efficacy (response rate, progression free survival and          overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy          including SCT.   "
81192|NCT02223195|"     Purpose and aims This as a pilot study to see which biomarkers can be found in saliva in     children with Juvenile idiopathic Arthritis (JIA).      The hypothesis is that children with JIA will show a different pattern of biomarkers in     saliva than healthy children The null hypothesis is that there are no differences.   "
81193|NCT02223182|"     The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12     months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's     milk allergic children and to assess the long-term safety and treatment efffect of up to 48     months of treatment with Viaskin Milk   "
81234|NCT02222649|"     A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers of     oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the VDR     gene would become non-responsive to supplementation.   "
81235|NCT02222636|"     The purpose of this study is to explore the optimal protocol for dexmedetomidine used in     children during perioperative period.   "
81194|NCT02223169|"     Heart disease and stroke are the most common cause of death in Ireland today.One of the main     risk factors for heart disease and stroke is high blood pressure or hypertension. Research     has found that certain specific proteins or peptides found in foods such as dairy, meat, fish     and eggs may promote heart health reducing blood pressure in adults with hypertension. The     aim of this study is to investigate the potential beneficial effects egg peptides may have on     heart health, in particular, effects on blood pressure.   "
81195|NCT02223156|"     The main purpose of this study is to investigate effect of Medi Yoga on quality of life,     biomedical factors and health care consumption, and to study gender differences between     individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional     purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects     their condition.      Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood     pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and CRP     are positively affected, and that individuals seek less medical care.   "
81196|NCT02223143|"     Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a leading     cause of morbidity and mortality. Dyslipidemia has long been recognized to be the most     important risk factor in the development of atherosclerosis in human beings. In Taiwan, the     rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980; and     17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970 and     13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor among a     good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol (LDL-C) with     statins has in the last decade become part of the standard treatment regimen in patients with     dyslipidemia. However, most embarrassing, is the insufficient data for clinical use in     Taiwan. It is necessary to have rationalized and balanced guideline for the management of     dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic research data.     Because all these trials were conducted in Caucasians and no large-scaled end-point research     about the lipid lowering therapy (LLT) was published in Asians before, this registry study     attempts to define the status of lipid lowering therapy in Taiwan and the effect of LLT on     CVD morbidity and mortality in a large population of patients receiving primary or secondary     prevention therapy. The medications will only depend on the decision made by the primary care     physicians. The patient or physician can decide to be withdrawn from this registry at any     time because of any reason. The lipid profile change, myopathy, or liver enzyme change after     the LLT will also be recorded.   "
81197|NCT02223130|"     The purpose of this research study is to test a group program aimed at improving the quality     of life of HIV+ Black men who have sex with men. The group will address ways to cope with     discrimination and will help men examine mistrust that they may have about healthcare,     including doctors and other healthcare providers and HIV medications. The aim is to provide a     supportive community for HIV+ Black men.   "
81198|NCT02223117|"     This first-in-human exploratory IND, single-center study will assess the safety, toxicity,     hematology, and immunogenicity of sub-therapeutic microdoses of autologous Thrombosomes® in     healthy human subjects.   "
81199|NCT02223104|"     The purpose of this study is to demonstrate that the performance of Flexima Active is     non-inferior to the performance of Sensura.   "
81200|NCT02223091|"     The aim of the study is to investigate the effect of a consultation training program for     physicians on the quality of their consultations of breast cancer patients regarding     complementary medicine. We assume that the training program might enhance the communication     of relevant information, empathy of the physicians or satisfaction with the consultation.   "
81201|NCT02223078|"     Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin     gene and to be sensitive to the trophic effects of the gastrin in animal models. The     hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that     will bind gastrin-17, thus preventing the trophic activity of cancer cells.   "
81211|NCT02222948|"     Primary Objectives:        -  To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in          new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS)          patients.        -  To evaluate multiple doses of vatelizumab for a dose-response.      Secondary Objectives:        -  To evaluate the safety and tolerability of vatelizumab compared to placebo.        -  To evaluate the pharmacokinetics (PK) of vatelizumab.   "
81212|NCT02222935|"     Balance problems are addressed in low back pain patients. Dearth of literature available to     prove core strengthening or any form of back exercises improving functional outcomes or     balance in chronic back pain patients. No studies focus on balance training in improving     balance of low back pain patients. The authors are conducting a randomised trial comparing     balance exercises and routine back exercise program in improving pain, functional outcomes     and balance of the patients   "
81213|NCT02222922|"     To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients     with advanced solid tumors in order to determine the maximum tolerated dose and select the     recommended Phase 2 dose.   "
81214|NCT02222909|"     Project CONNECT (Community-based Organizations Neighborhood Network: Enhancing Capacity     Together) is a randomized controlled trial that involves 22 community-based organizations     (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the     intervention group using a constrained cluster randomization process. The remaining 11 are a     part of the control intervention group. The intervention is a co-developed set of IT tools     hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care     facilities and CBO clients.   "
81215|NCT02222896|"     Demonstrate the reduction of bacteria on the skin   "
81216|NCT02222883|"     The aim of this prospective registration and translational research study is to evaluate the     praevalence of BRCA regarding germline and somatic mutations.   "
81259|NCT02222324|"     This thorough QT (TQT) study will take place in healthy subjects administered single doses of     study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment     crossover study. Subjects will be randomized in an equal ratio to one of 12 possible     treatment sequences. Each treatment sequence will comprise all 4 treatments.   "
81464|NCT02219659|"     A three-arm, randomized, pilot feasibility, study to assess the effect three validated     sedation strategies on outcomes of patient on mechanical ventilation.   "
81217|NCT02222870|"     The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone     Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the     Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to     < 9 years of age.      Objective:        -  To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine,          administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in          children 6 months to < 9 years of age.      Observational objectives:        -  To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP          recommendations, in children 6 months to < 9 years of age.        -  To submit available sera from each subject to Center for Biologics Evaluation and          Research (CBER) for further analysis by the WHO, the Centers for Disease Control and          Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation          recommendations for subsequent influenza vaccines.   "
81218|NCT02222857|"     Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to     devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and     disease course according to the diagnostic criteria proposed by the American Uveitis Society:     (1) one or more foci of retinal necrosis with discrete borders in the peripheral retina; (2)     rapid progression in the absence of antiviral therapy; (3) circumferential spread; (4)     occlusive vasculopathy with arteriolar involvement; and (5) a prominent inflammatory reaction     in the vitreous and anterior chambers.      Herpesvirus infection, especially varicella-zoster virus (VZV) and herpes simplex virus     (HSV), was presumed to be the pathogenic agent in the pathogenesis of ARN. Medical treatment     with systemic antiviral agent had been the base of the therapy of ARN for decades and such     treatment usually result in regression of retinitis.      However, the visual outcome of ARN remains poor. The major causes of poor visual prognosis in     ARN are retinal detachment and optic nerve or macular involvement by ischemic vasculopathy.     Less frequent causes include macular hole formation, macular pucker, or hypotony.     Rhegmatogenous retinal detachment may occur in 75 % of the untreated eyes. It may occur weeks     to months after the onset of inflammation due to delayed formation of retinal breaks, which     result from the combination of necrotic retina and vitreoretinal traction.      Therefore, application of argon laser retinopexy prophylactically posterior to necrotic     retina or prophylactic vitrectomy to reduce inflammatory factors and the vitreoretinal     traction had been used to protect the healthy area from detachment. However, the results were     varied and there is no consensus on the efficacy and indications of those prophylactic     procedures. We had applied the prophylactic procedure in our treatment for ARN. We aim to     access the efficacy of the treatment strategy of ARN and the correlated factors to the     outcomes.   "
81219|NCT02222844|"     The IMPRESS trial aims to see whether the improved results can be achieved for patients with     pelvic sigmoid cancers by having an MRI scan prior to surgery so that doctors can make the     most appropriate treatment choice.      Everyone who agrees to take part will be randomly allocated by one of the research team to     either have standard treatment for sigmoid cancer, which involves CT-imaging of chest and     abdomen / pelvis before surgery, or to undergo standard treatment, plus an additional MRI     scan, before surgery. The additional MRI scan will be the only difference in approach between     the two arms of the trial. After all imaging is obtained, patients from both arms will be     discussed by the Multidisciplinary Team as usual. An amendment to this study in 2015 allowed     for patients with sigmoid cancer who receive an MRI by local indication to be entered into     the trial as observational patients, and a new primary endpoint added that compares the rates     of high risk features identified between CT and MRI scans for all patients.   "
81220|NCT02222831|"     The aims of this study are to evaluate:        1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on          fertilisation rates and embryo quality in standard IVF.        2. the association between PIF status in embryo culture medium and embryo quality assessed          by standard subjective parameters and morphokinetic development.   "
81221|NCT02222818|"     The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac     Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF     Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF     when CAFR (Conducted AF Response) is applied.   "
81229|NCT02222714|"     The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary     efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human     activated protein C (APC), in in the treatment of acute ischemic stroke following treatment     with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.   "
81230|NCT02222701|"     The purpose of this study is to evaluate the clinical performance of resin composite     restorations refurbished and compare with 2 groups of resins, 1 without treatment and another     replaced resins acted as controls. The null hypothesis of this study is that the group of     refurbished resins have a similar behavior to the control groups.   "
81222|NCT02222805|"     The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or     late (≥180 seconds) clamping of the umbilical cord at birth. The children will be followed     with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development     is evaluated by questionnaire (Ages & Stages Questionnaire ) at 12 months of age, and by     testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with a     high proportion of anemia at one year of age (about 75%), we can reduce the number of     children in the study and still achieve significant results.      Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment in     children. Anemia is estimated by WHO to occur among 25% of all children before school age,     and the corresponding figure in Europe is 3-9 %.      By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume     remaining in the placenta is transfused over to the child's body. Research shows that the     neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months'     supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could     reduce iron deficiency in children at four months of age by 90%. Globally, most countries     practice early cord clamping and the child is deprived of the placental blood transfusion.     The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia at     8 and 12 months will be reduced an this in turn will be beneficial for the childrens     development.      The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It     hosts approximately 23,000 births annually.   "
81260|NCT02222311|"     The investigators wish to study the effect of Vitamin D on the development of autism in     children. The investigators will also investigate the environmental and genetic influences on     the level of Vitamin D in children with autism.   "
81664|NCT02217046|"     Cardiovascular implantable electronic device (CIED) infections have been increasing out of     proportion to the number of devices implanted the investigators investigated recent trends     and possible causes of the increasing numbers of Cardiovascular implantable electronic device     infections.   "
81223|NCT02222792|"     A national, prospective, open-label, non-interventional, multicentre, controlled study     designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder     prosthetic removal regardless of whether or not infection is suspected. Serological test     results will have no impact on the therapeutic approach.      Study objective: To evaluate the diagnostic performance of an antibody detection kit for the     serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci,     Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the     reference method: the bacterial culture of deep intraoperative samples.   "
81224|NCT02222779|"     In this trial, concentrations of transition metals of interest are quantified in surplus     cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals     will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating     physicians as well as the patients will not be informed about the results of drug     concentrations.   "
81225|NCT02222766|"     The obesity epidemic has spared no age group, including our youngest children. My and others'     formative research shows that ethnically-diverse, low-income parents of young children are     enthusiastic about learning general parenting skills, such as discipline strategies, but less     interested in nutrition and physical activity. To capitalize on this enthusiasm, I will     create and test an intervention that embeds strategies to improve child weight-related     behaviors within a general skills parenting program.      The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based     intervention to prevent obesity among children age 2 through 5 years. To achieve this goal,     my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically     diverse, primarily low-income families. Our specific aims are to:        1. Determine the extent to which the intervention, compared with a control condition,          results in a smaller age-associated increase in body mass index (BMI) among children          after a 3- month intervention and a 9-month follow-up period (primary outcome).        2. Determine the extent to which the intervention, compared with a control condition,          results in:             1. Improved parent general parenting behaviors, i.e., increased use of positive               discipline strategies.             2. Improved parent feeding practices, i.e., increased responsiveness to child satiety               cues.             3. Improved child weight-related behaviors, i.e., increased sleep duration and               physical activity, and reduced sugar-sweetened beverage intake and television/video               viewing.   "
81226|NCT02222753|"     Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports     concluded aberrant immunological function was associated with colorectal cancer outcome,     however, the influence of immunocyte subgroup and immunologic factors on cancer outcome in     colorectal cancer survivors is largely unknown.The investigators will explore the impact of     immunocyte subgroup and immunologic factors on colorectal cancer disease-specific,     disease-free and overall survival. The investigators will recruit approximately 5,000     patients as a prospective study cohort. During follow up, the investigators will explore the     association of these factors with outcome of patients. The investigators believe that this     project will improve the understanding of the impact of immunocyte subgroup and immunologic     factors on colorectal cancer outcome.   "
81227|NCT02222740|"     Assess the safety, tolerability and pharmacokinetics of multiple doses of 10, 20, 30, and 40     mg of Hydrocodone Bitartrate Extended Release (HC-ER)capsules taken with food at steady     state, in subjects with chronic, moderate to severe osteoarthritis (OA) pain.   "
81228|NCT02222727|"     Introduction      Aneurysmal subarachnoid hemorrhage (aSAH) is bleeding around the under surface of the brain     caused by rupture of an aneurysm arising from a blood vessel. Stroke may occur in     approximately one third of patients as a result of narrowing of the blood vessels around the     brain, following aSAH.      One theory as to why this may happen is because bleeding around the base of the brain damages     particular cells (neurons) that control blood flow around the rest of the brain. These     neurons may control blood flow by releasing a neurotransmitter called Acetyl Choline (ACh).     Our hypothesis is that damage to these neurons may prevent the production of ACh, which then     causes reduced blood flow and stroke if left untreated.      By stimulating these neurons, we aim to investigate whether it is possible to improve the     blood flow around brain and ultimately prevent strokes in patients following subarachnoid     haemorrhage. Donepezil, a drug widely used in dementia, inhibits the brain's natural break     down of ACh. We predict that by increasing the amount of Ach in these neurons, donepezil may     improve blood flow to the brain, reducing the chance of developing stroke.      Trial Protocol      All patients admitted to St George's hospital with a confirmed aneurysmal subarachnoid     haemorrhage between the ages of 18 and 85 years old will be invited to participate in the     trial. The protocol has been designed to take place around the patients' aneurysm treatment,     which is performed under general anesthesia (GA). Recruited participants will be anesthetized     for their aneurysm treatment and then enter the study.      All trial participants will have a Xenon CT scan under GA to assess brain blood flow prior to     having treatment of their aneurysm. Patients randomized to donepezil treatment will receive a     loading dose of 20mg via a feeding tube immediately after their Xenon scan. Patients in the     control group will not receive the drug.      All patients in the trial will undergo repeat Xenon perfusion scanning under GA between 3 and     4 hours after their first scan, which coincides with the completion of their aneurysm     treatment. Those in the donepezil group will then receive a daily dose of 5 mg for a period     of 21 days.      All aspects of care other than those related to the trial will be the same as for any other     subarachnoid haemorrhage patients. Patients (or their legal representative for those unable     to consent) will be able to decline participation in the trial or withdraw at any point.   "
81245|NCT02222506|"     The primary objective of these case series is to evaluate the safety and tolerability of the     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with     diabetic foot ulcers.   "
81231|NCT02222688|"     The purpose of the study is to investigate the safety of the investigational agent,     cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein,     called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth     and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get     rid of the cancer cells. Although there is evidence in laboratory animals that cirmtuzumab     can decrease the number of CLL cells, the investigators do not know if this will work in     humans. This drug will be given to humans for the first time in this study. Therefore, the     goal of this study is to see if cirmtuzumab is safe and tolerated in study participants.   "
81232|NCT02222675|"     Aim of the study is to test whether surgical removal of a tumor under sonographic control as     compared to conventional method reduces the rate of resections and local relapse   "
81233|NCT02222662|"     Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute     at Western Oregon University (WOU) will be conducting research on the effect of a     parent-delivered massage program on measures of autism and general development in children     ages 6 to 11 with autism. Families will participate in an initial training, and receive 24     sessions of ongoing support and training from a trained therapist over the first nine months.   "
81665|NCT02217033|"     The purpose of this study is to evaluate the effects of consuming R on quality of life in     the areas of insomnia, fatigue, and depression in female breast cancer patients receiving     multi-cycle adjuvant chemotherapy.   "
81236|NCT02222623|"     The purpose of this study is to compare the safety and effectiveness of the two different     basal insulins commonly used for basal blood sugar control in the treatment of type 2     diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral     protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown     that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of     blood sugar in a type 2 diabetic patient. This research is being done because the costs of     medications for diabetic patients are very expensive. Our goal with this research is to show     that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin     [glargine (Lantus®)] in patients with type 2 diabetes mellitus who are in the hospital.   "
81237|NCT02222610|"     The purpose of this study is to assess the tolerability and efficacy of ranibizumab treatment     administered in subjects with radiation retinopathy   "
81238|NCT02222597|"     The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma     detection of head trauma patients   "
81239|NCT02222584|"     Physical activity (PA) is beneficial in the prevention and management of chronic disease.     However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and     whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the     level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the     effect of PA on quality of life of patients with IBD.   "
81240|NCT02222571|"     This formative research shows that parents of preschool-aged children are enthusiastic about     learning general parenting skills, such as discipline strategies, but that they are less     interested in information on child nutrition and physical activity needs. To capitalize on     this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that     embeds strategies to improve children's nutrition and activity behaviours within an existing     general skills parenting program. Results from the investigators feasibility trial with 16     Boston-area parents show that PTT is feasible for implementation and is extremely     well-received by parents. Results are also encouraging with respect to changing parent     feeding behaviours and children's nutrition and activity behaviours. What is not known is     whether this program is feasible and contextually appropriate for Canadian families. Thus,     the next step in this research program, and the overall goal of this study, is to assess     Parents and Tots Together (PTT), a family-based intervention to prevent obesity among     children 3 to 5 years of age, within the Canadian context.      To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60     families recruited through Ontario Early Years Centres (OEYC). The investigators will     randomize 30 families to the 3-month PTT intervention and 30 to a control condition.      The investigators primary objective is to implement and test the feasibility and     acceptability of PTT among families with preschool children so appropriate revisions can be     made to adapt it to a Canadian context. The investigators secondary objective is to compare     the following outcomes among intervention versus control participants:        1. Parent weight-related behaviours (i.e., parent physical activity, intake of          sugar-sweetened beverages, and television/video viewing, as well as responsiveness to          child satiety cues).        2. General parenting behaviours (i.e., use of positive discipline strategies).        3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of          sugar-sweetened beverages, television/video viewing).        4. Nutritional risk score based on a screening tool for preschoolers.        5. Child change in body mass index (BMI), standardized to age and gender.   "
81241|NCT02222558|"     Low testosterone is a condition that occurs when the body is unable to produce sufficient     quantities of testosterone. The medical name for low testosterone is hypogonadism.     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of     energy and mood swings. The goal of testosterone replacement therapy is to return     testosterone levels to the normal range and relieve symptoms.   "
81242|NCT02222545|"     The purpose of this study is to assess the safety, tolerability, and clinical activity of     OMS721 in subjects with thrombotic microangiopathies (TMA), which include atypical hemolytic     uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell     transplant -associated TMA (HSCT-associated TMA). The study will also evaluate clinical     activity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response     (ADA).   "
81243|NCT02222532|"     Infants and children undergoing cardiac surgery require mechanical support for circulation     called cardiopulmonary bypass. The artificial pump ensures that blood flow to the body is     maintained during surgical procedure on the heart. However, the pump circulation disrupts     regulation of thyroid hormone. This hormone is a critical regulator of heart and circulatory     function. Deficiencies in thyroid hormone adversely affect recovery of the heart after     cardiac surgery. A recent study by the principal investigator showed that supplementing     patients younger than 5 months old shortened the time spent on the ventilator (breathing     machine) after surgery. Populations undergoing heart surgery in developing countries such as     Indonesia are different than those in the U.S. and other industrial nations. For many heart     defects children undergo surgery at an older age. They are then sicker for longer periods,     and are often malnourished. These older malnourished children have lower thyroid hormone     levels even prior to surgery, and show dramatic further drops after surgery. Shortening time     on the ventilator should improve their recovery, and also improve overall availability of     resources in developing countries. The formulation of thyroid hormone provided in the U.S and     given intravenous is relatively expensive. However, a much more inexpensive formulation is     available in Indonesia, which can be given through a tube extending from the nose to the     stomach. We propose testing this formulation made in Korea, known as Tetronine, in two     vulnerable populations in Indonesia: children younger than 5 months of age, and those older     than 5 months who are malnourished. All these patients will be undergoing cardiopulmonary     bypass for congenital heart defects. This project will be an important collaboration between     U.S and Indonesian investigators. If successful, it will have a general positive impact on     care of the entire population of young children undergoing cardiac surgery in developing     countries by reducing time on the ventilator and improving access to care.   "
81244|NCT02222519|"     provide evidence for prevention or reduction muscle pain.   "
81251|NCT02222428|"     The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD     1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following     inhalation of the fixed dose combination (FDC) of 6.2 μg BI 1744 CL plus 727.3 μg BI 54903 XX     (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation     of the mono compounds of 10 μg BI 1744 CL (as aqueous solution for inhalation, AIS) and 727.3     μg BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler     (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary     objectives were to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the     BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare     exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the     BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare     the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI     54903 XX (6.2 μg/727.3 μg) FDC and as the mono compounds, respectively.   "
81252|NCT02222415|"     Resistance type exercise training has been shown to be a potent stimulus to increase skeletal     muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to     affect the muscle adaptive response following exercise. Whether timed protein intake could     augment the increase in muscle fiber size and/or satellite cell content following long-term     exercise intervention remains to be established.      We hypothesize that protein supplementation before sleep, on both training and non-training     days, during a 12 week resistance training program further increases type II muscle fibre     cross sectional area when compared to the placebo group.   "
81253|NCT02222402|"     The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise     training intervention designed to improve quality of life (QOL) and alleviate functional     limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis.     Exercise rehabilitation will be compared against established treatment options available     within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the     experience and acceptability of the intervention for both participants and members of the     renal care team. In addition, we want to examine whether this type of additional exercise     treatment is cost effective within the health service setting.      PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380     adult patients who have been on HD for at least 3 months, from 10 HD sites located in     Scotland, England and Wales. The type of exercise programming will consist of cycling     exercise performed during each dialysis session plus a muscle conditioning programme     performed twice per week. All exercise sessions will be supervised by a physiotherapy     assistant. The exercise prescription will be individualised for all patients on the basis of     their fitness and clinical status.      The main objective is to examine the impact of exercise rehabilitation on quality of life and     well being of patients. We hypothesise that the exercise training delivered during     haemodialysis treatment will significantly improve the functional limitations/abilities of     the patients leading to the detection of clinically beneficial improvement in quality of life     outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end point.   "
81254|NCT02222389|"     Contingency management (CM) is a type of treatment used in the substance abuse field.     Patients' behaviors are rewarded for adherence to a treatment plan. As an approach to     treatment, contingency management emerged from the behavior therapy traditions in mental     health. By most evaluations, contingency management procedures produce one of the largest     effect sizes out of all mental health and educational interventions.      The purpose of this study is to perform a randomized, controlled trial to evaluate the     ability of a culturally-tailored contingency management (CM) intervention to increase alcohol     and drug abstinence among American Indian (AI) tribal members from two rural reservations in     the Northwest.   "
81255|NCT02222376|"     Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of     various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and     vascular endothelial growth factor, among others) that possesses anti-inflammatory and     anti-fibrinolytic properties.      The aim of this study is to compare the effect of topic treatment with pirfenidone compared     to conventional treatment in chronic diabetic foot ulcers.      The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers     (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional     treatment. This is a randomized, controlled and crossover study. Patients will be randomly     assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this     period they will change groups. Each week ulcers will be for size, depth, length and evidence     of infection. The ulcers will have proper debridement in the conventional treatment group and     debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be     instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in     addition to cleansing they will be instructed to apply the gel twice a day.   "
81256|NCT02222363|"     The purpose of this study is to evaluate the safety and tolerability of the investigational     drug VLX600 in patients with refractory advanced solid tumors.   "
81257|NCT02222350|"     The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with     placebo in Japanese patients with Type 2 Diabetes Mellitus.   "
81267|NCT02222220|"     Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable     adverse effect of clozapine therapy that can lead to noncompliance. Until now there is no     effective enough treatment for this side effect.      Previous studies demonstrated that different medications from the substitute benzamide     derivatives group: amisulpride, sulpiride (higher selective binding to the D2/D3 dopamine     receptor) and moclobemide (reversible inhibitor of monoamine oxidase A, which inhibits the     deamination of serotonin, norepinephrine and dopamine) may be effective as a treatment of     clozapine-induced hypersalivation (CIH). Moreover, there is another substitute benzamide     derivative: metoclopramide (dopamine D2 antagonist, usually used as antiemetic medication in     general medicine). The investigators hypothesis assumes that anti-salivation effect     characterizes the whole group of benzamide.      The aim of this study was to examine the efficacy of metoclopramide as an optional     possibility for management of CIH.   "
81998|NCT02212665|"     The aim of the study 'Live - without diabetes' is to investigate the effects of increased     physical activity on a daily basis with or without (high intense interval training) HIIT     (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes   "
81258|NCT02222337|"     Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors.     Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and     family of Latina cancer patients are also impacted by a loved one's diagnosis of breast     cancer. Through strong community-academic partnerships, the investigators seek to improve the     QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this     project, the investigators plan to further develop and refine the intervention and then test     it through a randomized controlled trial. First, the investigators will conduct in-depth     qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention     fits for survivors and caregivers in different parts of the country. Then, the investigators     will revise the intervention. Finally, the investigators will test the intervention in a     randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be     a part of our study. Half will be asked to complete the intervention and half will be offered     the usual services, such as support groups. The information learned from this study could     help improve the quality of life in Latina breast cancer survivors and their caregivers.     Physicians, survivors, and community groups can also benefit from this study because they     will have more information about the needs of Latina breast cancer survivors. The     investigators hope to use the information to help other types of survivors and caregivers in     the future.   "
81272|NCT02222155|"     The aim of this trial is to test the safety and efficacy of two dose regimens of the     complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody     (ANCA)-associated vasculitis (AAV).      Funding Source - FDA OOPD   "
81261|NCT02222298|"     Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive     treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have     designed a comparative study between the conventional and the minimally invasive treatment.     Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision     with a Bascom out-midline closure (Control group).   "
81262|NCT02222285|"     The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related     symptoms in children.   "
81263|NCT02222272|"     Stem cell transplantation will continue to be a treatment option for patients with chronic     myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many     patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the     time of allogeneic stem cell transplantation.      While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact     on the outcome of allogeneic stem cell transplantation little is known on the impact of prior     use of second generation TK inhibitors.      Therefore this non interventional prospective study addresses this question and patients     undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will     be followed by the data office office on engraftment, treatment related mortality, relapse     rate and survival, prospectively. Details on TKI therapy will be collected by the     participating centers, retrospectively.      This is a non interventional prospective study. There is no upper limit to the number of     patients entered, but it is estimated that up to 450 patients will be included in 150 centres     for this non interventional prospective study. The registry will include patients for three     years plus one more year for follow up and data analysis which should then be followed-up     until the projected end of the non interventional prospective study.   "
81264|NCT02222259|"     The purpose of this study is to determine the feasibility of implementing a randomized     controlled study of the intervention (Geriatric Assessment followed by an integrated care     plan carried out by the multidisciplinary geriatric oncology team) designed to     maintain/improve quality of life and functional status in older adults with advanced     gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.      Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer     treatment decision of the cancer specialist.   "
81265|NCT02222246|"     The goal of this pilot study is to improve emergency department (ED) pain management for     adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic     disorder in the United States, and occurs primarily among African Americans. Management of     painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most     common reason for SCD patients to visit the ED. Currently, there is no standard approach to     managing VOC pain in the ED that is widely accepted and used, and pain management for     vaso-occlusive crisis in persons with SCD is very different between providers and not based     on research. Many times, patients who come to the ED with sickle cell pain feel that they do     not receive adequate pain control. If EDs could provide efficient, effective, safe,     patient-centered analgesic management, it may be possible to improve pain management for     adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by     sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of     the National Institutes of Health. These guidelines recommend patient-specific pain treatment     protocols or a standardized pain management protocol for SCD when a patient does not already     have a pain treatment protocol designed for them. The purpose of this pilot study is to     compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell     disease, and to determine if a large randomized controlled trial is feasible and required.   "
81266|NCT02222233|"     To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline)     administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as     solution to the jejunum, ascending or descending colon, or as particulate to the ascending     colon   "
81283|NCT02222012|"     The investigators propose a multi-source pattern which integrates neuroimaging data     associated with multiple, symptom-related neural processes relevant in depression to improve     classification accuracy. The investigators conclude that combining brain activation related     to the core-symptoms of depression using the multi-source monitoring data substantially     increases classification accuracy while providing a sparse relational neuromarkers-model for     future prediction.   "
81268|NCT02222207|"     Part A (Phase IIa):      Primary objectives:      The study part A is designed to investigate whether the use of regorafenib eye drops can help     patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4     weeks and 12 weeks after inclusion into this study.      Secondary objectives:      The study will also evaluate the safety and tolerability of the regorafenib eye drops.      Part B (Phase IIb):      Primary objectives:      The study part B is designed to investigate:        -  how often the regorafenib eye drops need to be given per day        -  whether the use of regorafenib eye drops can help patients with neovascular (wet)          Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after          inclusion into this study.      Secondary objectives:      The study will also evaluate how the different dosings of regorafenib eye drops affect     patients vision, the safety and the tolerability.   "
81269|NCT02222194|"     In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging     by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for     echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal     nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a     prospective multicentric observational study to measure the sensitivity of mediastinal     staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable (suspected)     NSCLC patients.   "
81270|NCT02222181|"     In Brazil, patients with Alzheimer's disease (AD) receiving free drugs of government. Even     having access to, little is known about the effectiveness, safety and adherence of drug     therapy in this group of patients. The research aims to promote adherence and develop     strategies to address Drug-Related Problems (DRP's) in AD patients elderly of reference     centre for the Elderly of Araraquara. The clinical parameters will be assessed at the     beginning and after the educational intervention period from April 2014 to April 2015.   "
81271|NCT02222168|"     To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the     pharmacokinetics of BI 409306 when given at bed time.   "
81276|NCT02222103|"     The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm     Diagnostic Systems, Inc. which has many sensors inside in a Band-Aid like strip in order to     see if it can help diagnose capabilities in individuals suspected of having obstructive sleep     apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered,     flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of     physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen     saturation, temperature, respiratory rate, depth of respiration and motion/position. One     advantage of this device over current home diagnostic systems is the capability for recording     over several nights.      The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold     standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will     explore potential findings supportive of sleep apnea while monitoring at home during routine     sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated     sleep study will help us to make these determinations. Subjects will wear the device, which     is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects     will go about their normal daily activities and return the device via mail once completed.   "
81277|NCT02222090|"     The aim of the present registry is to characterize and follow patients prospectively and     retrospectively with renal impairment who have been prescribed apixaban for the prevention of     stroke in atrial fibrillation, with a comparison to the characteristics and outcomes     associated with warfarin therapy in this population.   "
81278|NCT02222077|"     This study aims to investigate in adolescents and young adults:        -  the 24h diurnal variation of ambulatory central blood pressure        -  the association of central compared to peripheral blood pressure with indices of          asymptomatic target-organ damage   "
81279|NCT02222064|"     Research questions/hypotheses        1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients          reduce pain-related distress, improve quality of life, and increase confidence in pain          self-management?        2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness          methods?   "
81280|NCT02222051|"     In this study the efficacy of Tai Chi will be tested in comparison to conventional neck     exercises and usual care in a randomized controlled trial. Tai Chi and neck exercises will be     lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks of     training, once weekly for 60-90 min in a group setting. Pain, Disability, quality of life,     wellbeing, stress perception, psychological distress will be used to determine effects.   "
81281|NCT02222038|"     The purpose of this study is to investigate the genetic architecture of Linear Localized     Scleroderma (LLS) (linear morphea) by whole exome sequencing.   "
81282|NCT02222025|"     Playing football can induce considerable beneficial health effects, but is also a     high-intensity and high-impact sport with many situations of direct contact between players     which bear the risk of injury. Thus, it is necessary to implement preventive measures to     reduce the risk of injury and support the health benefits.      Injury characteristics of players older than 13 years are similar to adult players and, thus,     similar preventive measures are beneficial. Younger players seem to show partly different     injury characteristics. Consequently, preventive programmes proven effective in late     adolescent or adult players need to be adapted for younger age groups. To date, no study     investigated the prevention of football injuries in children under the age of 13 years.      We aim to assess the effectiveness of an exercise-based prevention program to reduce     football-related injuries in children younger than 13 years.      The primary outcome in this study is the overall injury rate. Secondary outcomes are the rate     of severe injuries and acute injuries.      The study is designed as a two-armed cluster-randomized controlled trial. We will recruit 9     to 12 years old children (boys and girls, born 2002 to 2005) participating in regular     training and match play in an officially registered football club in Switzerland (further     study centres are located in the Netherlands, Germany and the Czech Republic). The chosen age     group is usually subdivided into two age categories (9/10 years, 11/12 years).      Recruitment will take place via the national and regional football associations.      Inclusion criteria are: the clubs must be officially registered in the regional football     association, children must be between 9 and 12 years old at the start of the study and     regular training must take place at least twice per week. Teams will be excluded, if the     coaches already perform a structured warm-up focusing on neuromuscular control or an existing     injury prevention programme.      Injury surveillance will include a baseline questionnaire, players´ exposure and injury     registration. Anthropometric baseline data and information regarding previous     football-related injuries will be obtained prior to the start of the study from the parents.     Injury and exposure surveillance will be assisted by an automated internet-based injury     recording system which has been developed and applied during our own epidemiological project.      For all participating teams, one contact person will be appointed. Those persons will be     provided with exact instructions on injury definitions as well as examples how to complete     the injury and exposure forms within the online injury recording system.      If an injury occurred, one trained person will contact the coach as well as the player and     the parents by telephone and/or e-mail to assess all relevant aspects of the injury based on     a standardized injury registration form. In case of injuries which require medical treatment     parents will be supported to receive the exact diagnosis from the attending physician (either     as specific written diagnosis or by use of a specific injury coding system). Two blinded     investigators will additionally assess all information with regard to each injury to allow     for objective and independent injury surveillance.      20 study assistants and 4 scientific assistants will support coaches with data collection and     injury recording. Each study assistant will be responsible for eight clubs. Study assistant     will regularly keep in touch with the clubs and will visit two training sessions of each team     during the study period.      The intervention period will last one complete season. The injury prevention program will be     included at the beginning of the usual football training by replacing the traditional     warm-up. The programme will be conducted at least two times a week by the intervention teams.     The prevention programme contains seven exercises and lasts about 10 to 15 min after     familiarisation. Three exercises focus on unilateral, dynamic stability of the lower     extremities (hopping, jumping and landing). Further, three exercises emphasize whole body and     trunk stability. The last exercise contains rolling movements to improve fall technique.      The coaches of the control group will receive the instruction to regularly perform a common     warm-up consisting of running and ball-based exercises (sham treatment, no neuromuscular and     stability exercises).      The yearly incidence injured players in children is 8.6%. A risk reduction of one third has     been recently acknowledged as a relevant effect size for injury rate. This corresponds to a     reduction of the yearly incidence to 5.8% injured players. In order to achieve a statistical     power of 80% and taking an allocation ratio of 1:1 and a cluster-inflation factor of 1.7 into     account, in total 4´000 players are needed for statistical analysis. Assuming a realistic     drop-out rate of about 33%, 6´000 children will be initially recruited.   "
81319|NCT02221544|"     This study is a double blind comparative study examining the effectiveness of the rTMS     treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We     hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait     quality and decrease the frequency of FOG in patients with Parkinson's disease.   "
81284|NCT02221999|"     The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based     regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast     cancer.      In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined     with endocrine therapy may improve the pathological remission rate.      Premenopausal patients with triple negative breast caner and hormonal receptor positve breast     cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine     therapy or not.   "
81285|NCT02221986|"     The results of the present RCT study will add to the growing body of literature investigating     the potential role of exercise as a supportive therapeutic intervention for patient with     glioma.   "
81286|NCT02221973|"     The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids     reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial:     demonstrate potential to reduce total blood cholesterol more than 10% and/or total     triglycerides more than 15%, as required by State food and drug administration (SFDA)     regulation.   "
81287|NCT02221960|"     To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with     recurrent or metastatic solid tumors.   "
81288|NCT02221947|"     This study is being done to evaluate the safety, tolerability and potential effectiveness of     a new investigational drug, bryostatin 1, in patients with Alzheimer's disease (AD).   "
81289|NCT02221934|"     The purpose of the clinical trial is to learn whether electrical nerve block is a safe and     effective treatment for patients with post-amputation pain.   "
81290|NCT02221921|"     The objective of this study is to evaluate the safety and effectiveness of the MicroPort's     Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic     stenosis who are considered unsuitable for Surgical Valve Replacement.   "
81291|NCT02221908|"     The goal of this study is to assess decision making skills of emergency physicians when     dealing with hypotensive patients. The hypothesis is that decisions made based on physical     exam and vital signs regarding fluid resuscitation by emergency physicians are not     statistically equivalent to those that would be made based on the use of a non-invasive CVP     measurement   "
81292|NCT02221895|"     The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week)     postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The     study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher rate     of breastfeeding 6 months postpartum.   "
81293|NCT02221882|"     The main purpose of this study is to evaluate the safety of a study drug known as LY3164530     in participants with cancer that is advanced and/or has spread to another part(s) of the     body.   "
81294|NCT02221869|"     The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics     subjects with narcolepsy that includes cataplexy.   "
81606|NCT02217800|"     This study is designed to assess the effect of the different continuous s.c. infusion     treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in     comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the     safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.   "
81295|NCT02221856|"     Technological advances have made computer aided orthodontic treatment planning possible. 3D     dental scanners and software make it possible to design and approve the outcome before     treatment begins. Manufacturers have provided different customized appliance systems that     would help practitioners achieve those computer-designed outcomes. The purpose of this study     is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at     achieving the predicted alignment and comparing that to the accuracy of conventional     orthodontic bracket placement at achieving a predetermined goal. The results of this study     will help orthodontists and patients know if there is an advantage to using custom     appliances. The study will be a prospective clinical study and will include a total of 60     arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will     be assigned to each of the two study groups (Motion View or control). Both groups will have a     3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated     design that the orthodontist believes is the optimized outcome. At the end of each patient's     participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and     alignment using ABO's objective grading system's criteria for alignment, marginal ridges and     buccolingual inclination. Each arch will then be superimposed on the predicted outcome to     determine how accurate each system was at achieving the planned movements in all 3     dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion     View) at achieving the predicted outcomes will differ in comparison to the accuracy of     conventional orthodontic bracket placement at achieving a predetermined goal.   "
81296|NCT02221843|"     Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of     this study is to track sun behavior of patients at high risk for skin cancer, to investigate     the feasibility of this prototype in daily life and to investigate the technical accuracy of     the Sunbit.   "
81297|NCT02221830|"     Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in     patients with pre-eclampsia (PE)   "
81298|NCT02221817|"     Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with     trochanteric bursitis experience chronic intermittent or continuous hip pain at and around     the greater trochanter.      The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa,     though this has not been confirmed. Accordingly, the use of corticosteroid injections has     been shown to provide considerable relief. However, routine blind injections, those     performed without the aid of imaging, such as fluoroscopy, have shown limited success in the     appropriate needle placement. Fortunately, blind injections have yielded positive results in     majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical     outcome for trochanter bursa injections.      Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such     as ultrasound have not been studied and may be more useful. Fluoroscopy allows for     bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue     structures such as the bursa and has gained significant support for use in musculoskeletal     injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an     ultrasound guided injection and whether ultrasound should be routinely used during trochanter     bursa injections.   "
81368|NCT02220907|"     The purpose of this study is to evaluate the safety and efficacy of co-administration of     Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese     patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and     have inadequate glycemic control.   "
81299|NCT02221804|"     Chronic Obstructive Pulmonary Disease (COPD) is the most common pulmonary disease,     responsible for considerable morbidity and mortality and is the third leading cause of death     worldwide. As well as its consequences in the lungs, COPD is well recognized to be associated     with a range of important systemic consequences and co-morbidities. Interestingly, skeletal     muscle dysfunction is noted in both early and advanced disease, suggesting its origins may     not be wholly pulmonary.      Treatment strategies targeting lung function are, unfortunately, of limited value. Given the     burden of disease, it is becoming increasingly important that investigative and therapeutic     work now focuses on other systemic characteristics and sequelae which define the disease     phenotype.      This is a randomized controlled trial of the effect of 14 days of voluntary reduced activity     on muscle mass, muscle strength, body composition, and atrophy signalling in patients with     COPD and age-matched controls.      The primary hypothesis upon which this study is based is that a short reduction in ambulation     will induce a transient reduction in quadriceps muscle mass, quadriceps strength and physical     performance in patients with COPD compared to matched COPD patients whose mobility has not     been restricted.      The secondary hypothesis is that the magnitude of the above changes will be greater in     physically inactive COPD patients compared to physically inactive age-matched controls.      The overall aim of this research is to use an in vivo human model of 14 days of voluntary     reduced physical activity to test the above hypotheses. If the model proves feasible, this     will allow for earlier proof of concept studies of novel therapeutic agents.   "
81300|NCT02221791|"     Intervention studies support a protective effect of flavonoid-rich foods such as chocolate     and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin     improves markers of vascular function and insulin resistance although the results were less     pronounced than the majority of chocolate intervention studies.      The food matrix of chocolate or other compounds present in chocolate could play a role in the     bioavailability of flavonoids, resulting in these heightened improvements in vascular     function.      In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid     chocolate on markers of vascular function.   "
81301|NCT02221778|"     This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed     Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation     Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our     population of patients.   "
81336|NCT02221323|"     The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin     lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both     state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin     efficacy after injection into these different areas is still unclear. The results from this     study may expand the knowledge on the severity of this issue and may provide evidence for     future treatment recommendations regarding injection sites for insulin administration.   "
81302|NCT02221765|"     Obesity is a growing pandemic which affects 1 in 4 adults in the UK, and shortens life by     increasing cardiovascular disease, diabetes and cancer. Current treatments for obesity have     either poor efficacy or significant side effects. Pancreatic polypeptide (PP) is a promising     new drug target as it produces powerful appetite suppression which, following a 90-minute     infusion continues to act for 24 h in man. We have developed a new long lasting high potency     analogue of PP, PP1420. This is delivered as a once-a-day subcutaneous injection via a     painless fine-gauge needle.      In a first-time-in-man Phase 1a trial, that PP 1420 proved safe, well tolerated, and had     extended pharmacokinetics compared to PP itself.      We now plan to study the safety and PK of PP1420 up to 64mg. We will also assess:        1. Its efficacy in reducing food intake after a single dose in a Phase 1B study in healthy          volunteers.        2. Its efficacy in reducing food intake and weight after multiple dosing in a Phase 1C          study in healthy volunteers.   "
81303|NCT02221752|"     According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant     women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at     the same time showed that the prevalence of IDA among pregnant and lactating mothers was     46.39% and 47.21% respectively. There was a significant difference between urban and rural     areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF     recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we     don't know much about their influence on maternal and infant health and their clinical     effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy     and during early pregnancy. But for various reasons, not all expecting mothers take this     advice. Besides, we don't have a national level technical standard of how to take nutrition     supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or     folic acid only can prevent perinatal complications, as well as their influences on infant     and toddler health.      The purpose of this study is to test whether taking iron/folic acid and folic acid only from     early pregnancy until delivery will lower the chances of pregnancy complications, and to see     how supplements affect gestation results. As well, it will evaluate a) whether taking iron     supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron     supplement can increase mother and fetus iron storage; and c) how mother's iron level affects     newborn's iron level. We hope to understand nutrition conditions during pregnancy and     investigate the relations between pregnancy diet and complications during pregnancy, weight     gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking     iron and folic acid during pregnancy on the health of infants and toddlers.   "
81304|NCT02221739|"     The purpose of this study is to investigate how effective and how safe the combination of     radiation therapy and an investigational medication targeting the immune system known as     Ipilimumab in the treatment of metastatic non-small cell lung cancer (NSCLC).      The investigators would like to see if this combination of radiation and Ipilimumab can     stimulate the body's immune system to stop the growth of tumors that are outside the field of     radiation. The investigators would like see if using this combination of radiation therapy     with Ipilimumab could help the body reject the patient's own tumor or at least help their     immune system to maintain the disease stable and/or slow its growth.      Radiation therapy (RT) is currently a standard procedure for treatment of NSCLC. Ipilimumab     is considered an investigational medication because it is not approved by the Food and Drug     Administration (FDA) for the treatment of NSCLC. Ipilimumab has been approved by the FDA for     the treatment of metastatic melanoma.   "
81305|NCT02221726|"     The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive     quality of placebo (an inactive substance that is compared with a drug to test whether the     drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the     skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch     sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).   "
81332|NCT02221375|"     The objective of the study was to investigate safety, tolerability and pharmacokinetics of     butylated hydroxytoluene (BHT) (sub-study 1) administered via Respimat® Soft MistTM Inhaler B     (SMI B); to assess safety, tolerability and pharmacokinetics of multiple rising doses of BI     54903 XX administered via Respimat® SMI B (main study), and to compare systemic exposure of     single dose BI 54903 XX administered via Respimat® SMI B (sub-study 2) with single dose     Alvesco® (ciclesonide) administered via HFA-134a propellant metered dose inhaler (MDI).   "
81391|NCT02220608|"     The purpose of this research study is to determine the highest dose of a drug called     bortezomib that can be given with a drug called G-CSF before stem cell collection to help in     the mobilization of stem cells.   "
81306|NCT02221713|"     Colonic diverticula are outpouchings of the large bowel, and they occur in up to 60% of     people over 60 years of age. About 10-25% of patients with diverticula will have symptoms.     These can range from acute diverticulitis, which can be a lethal infection to symptomatic     diverticular disease, which involves inflammation of the bowel and altered bowel habits,     decreasing patients' quality of life. We do not know which patients will develop acute     diverticulitis or which patients will develop diverticula in their colon.      We believe that diverticulitis may be associated with, or even caused by, alterations in the     bacteria that live in the colon, known as the gut microbiome. Until recently it was too     expensive and too complex to examine the microbiome in detail. We propose to examine for the     first time in detail the microbiome of patients with acute diverticulitis and asymptomatic     diverticulosis.      Stool samples will be analysed for gut microbiome composition by 16S ribosomal RNA gene     pyrosequencing. There is a part of the bacterial cell, the ribosome, which is the same in all     bacteria (16S). Through PCR, polymerase chain reaction, and sequencing, we can separate out     the different types of bacteria in a sample. We can then look at the different kinds of     bacteria in each patient population, as well as how diverse the populations are within the     groups, and compared to other groups.      We hope to be able to discriminate between the microbiome of patients with acute     diverticulitis and asymptomatic diverticulosis. This study many change how diverticulitis and     diverticulosis are conceptualized and treated. Alterations in the microbiome in these disease     states may be able to be treated, preventing further disease.   "
81307|NCT02221700|"     The goal of this research study is to compare the level of effectiveness of two massage     treatment schedules for chronic CIPN in people treated with Oxaliplatin or taxanes     (docetaxel, paclitaxel) for their cancer (breast and gastrointestinal) . Researchers also     want to study how participants may respond to massage treatments, and how the treatments may     affect quality of life and physical performance.   "
81308|NCT02221687|"     The primary objective of this study is to demonstrate that a synbiotic formula, fed for the     duration of the first year of life (infant and follow-on formula) reduces the incidence rate     of episodes of infectious diarrhea in infants during the first year of life compared to a     standard infant formula.   "
81337|NCT02221310|"     Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with     chemotherapy followed by allogeneic stem cell transplantation will be given to patients with     high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).   "
81309|NCT02221674|"     This is a multicenter, open-label (all people involved know the identity of the     intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are     absorbed in the body, how are they distributed within the body and how are they removed from     the body over time) in children aged from birth to less than 2 years after a scheduled     surgical procedure that routinely produces moderate to severe acute post-surgical pain.      The trial will also evaluate the safety and tolerability of tapentadol oral solution in the     population studied and the effect of tapentadol oral solution on pain.   "
81310|NCT02221661|"     The purpose of this study is to assess the performance of AclarusDx™, an investigational     blood test detecting gene expression information, and intended to help physicians in making     an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive     impairments.   "
81311|NCT02221648|"     The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA     (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.      The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A     into erector spinae muscles (extensors of the spine) can relieve low back pain through     anti-spasm and analgesic effect of botulinum toxin.   "
81312|NCT02221635|"     The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic     stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary     Outcome Measures:Time between subject randomization to treatment and the first occurrence of     a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as     measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores;     Illness severity change as measured by Clinical Global Impression of Severity for depression     (CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale;     Change in subject medication satisfaction using the Medication Satisfaction Questionnaire     (MSQ).   "
81313|NCT02221622|"     The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a     naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease     participants. The primary goal is to determine the maximally tolerated dose.   "
81314|NCT02221609|"     The objective of this study is to investigate the efficacy of a treatment based on Movement     System Impairment based classification (MSI) model in patients with chronic non-specific low     back pain.   "
81315|NCT02221596|"     The purpose of this study is to identify the magnitude of muscle lipid redistribution and     muscle oxygen use in individuals 60 years old or older following combined treatment of     vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic     training alone, or no treatment.   "
81316|NCT02221583|"     The purpose of this study is to evaluate how quickly and to what extent different     immunosuppressants are absorbed into the blood (this is called pharmacokinetics) in renal     transplant candidates who have undergone a laparoscopic sleeve gastrectomy. The immune system     is the body's defense against diseases. It also attacks foreign tissues such as a     transplanted kidney. Immunosuppressant medications such as Astagraf sustained release (XL),     Prograf, and mycophenolate mofetil may be given to suppress the immune system following     kidney transplantation and prevent rejection of a transplanted kidney. This study is being     performed to determine if patients who undergo laparoscopic sleeve gastrectomy need different     doses of immunosuppressant medications.   "
81317|NCT02221570|"     Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism     of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are     associated with significantly diminished quality of life.      The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps     in patients with liver cirrhosis.   "
81318|NCT02221557|"     A case series to compare the handling and effectiveness of two different treatment approaches     using a new alloplastic bone graft material in ridge preservation compared to allograft     existing historical data.   "
81392|NCT02220595|"     This study compares cognitive function after carotid endarterectomy and stenting.   "
81320|NCT02221531|"     Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml     after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood     transfusion within 24 hours after delivery (World Health Organization, Recommendations for     the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009).     Since PPH is more common after caesarean deliveries than after vaginal births and the rate of     CS is rising over time and will probably continue to rise, the incidence of PPH is expected     to increase accordingly.      A meta-analysis has shown that routine administration of an oxytocic agent after caesarean     delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane     Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery     are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over     oxytocin of having a longer half-life and therefore reducing the use of additional     uterotonics. Based on the findings of reduced cardiovascular side-effects with a     short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J     Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin     minimises the cardiovascular side effects without compromising the uterine tone. Therefore,     we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid     compared to a bolus application in women undergoing primary or secondary caesarean delivery.     This prospective, double-blind, randomised controlled non-inferiority trial will take place     at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be     inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a     short-infusion than after a bolus administration (primary safety endpoint).   "
81321|NCT02221518|"     The purpose of this study is to examine the brain functioning of OCD patients and healthy     controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.   "
81322|NCT02221505|"     LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ     antibody conjugated to a maytansine payload via a non-cleavable linker.      LOP628 provides an opportunity to target cKit overexpressing tumors.   "
81323|NCT02221492|"     Primary Objective:      To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte     colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a     target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in     4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.      Secondary Objectives:        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL          participants.        -  To compare the 2 treatment arms with respect to the number of participants who achieved          a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.        -  To compare the 2 treatment arms with respect to the number of days of apheresis required          to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.   "
81324|NCT02221479|"     Primary Objective:      To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating     factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of     greater than or equal to 6 x 10^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer     days of apheresis than MM patients mobilized with G-CSF alone.      Secondary Objectives:        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM          patients.        -  To compare the 2 treatment arms with respect to the number of participants who achieved          a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.        -  To compare the 2 treatment arms with respect to the number of days of apheresis required          to reach the target of greater than or equal to 6 x 10^6 CD34+ cells/kg.   "
81325|NCT02221466|"     The purpose of this clinical study is to test whether or not patients treated with HBOT for     diabetic foot ulcers will demonstrate measurable changes of the blood vessel function during     the course of HBOT treatments. , i.e. an expected increase in the reactive hyperemic index     (RHI) measured by the peripheral arterial tonometry (PAT).   "
81326|NCT02221453|"     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.     The retina is like the film of a camera and is located in the back of the eye. This condition     can develop in diabetics where swelling results from leaking of fluid from the blood vessels     of the eye, into the center of the retina, the macula. If left untreated, this can affect     central vision. The current standard treatment for diabetic macular edema includes     medications injected directly into the eye (intravitreal injections) and laser eye treatment.     The drugs that are injected directly into the eye are known as anti-Vascular Endothelial     Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes bevacizumab     (Avastin®) and ranibizumab (Lucentis®).      However, some patients do not respond well to these anti-VEGF treatments will be given the     option of switching to an another class of medications, called steroids. Triamcinolone     acetonide is one of these steroids and is also injected directly into the eye. These steroids     will help reduce inflammation and possibly as a consequence, reduce swelling in the eye.      The purpose of this study is to determine what cellular factors affect a patient's treatment     response (amount of swelling reduction) following triamcinolone acetonide intravitreal     injections for diabetic macular edema.   "
81327|NCT02221440|"     Supplementary oxygen is routinely administered to patients, even those with adequate oxygen     saturations, in the belief that it increases oxygen delivery. However, oxygen delivery     depends not just on arterial oxygen content but also on perfusion.      Maternal oxygen administration has been used in an attempt to lessen fetal distress by     increasing the available oxygen from the mother. However, the effect of supplemental maternal     oxygen therapy on fetal acid base status has been debated for more than seven decades.      Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second     stage of labor can relieve fetal distress.   "
81328|NCT02221427|"     The purpose of this study is to evaluate if the rate of emergency caesarean section can be     reduced if adhering to a dynamic labour progression curve compared to a static progression     curve for first time mothers without jeopardising maternal and neonatal outcomes   "
81329|NCT02221414|"     Study to demonstrate bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose     combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 500     mg administered together   "
81330|NCT02221401|"     Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose     combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin     1000 mg administered together.   "
81331|NCT02221388|"     To compare the oral bioavailability and rate of absorption of two different formulations of     BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without     EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA     formulations were further investigated concerning food effect and one of the two BI 671800     HEA formulations identified by interim pharmacokinetic analysis was further investigated     concerning dose proportionality with 50 mg.   "
81333|NCT02221362|"     Study 701-901, a multicenter, multinational, longitudinal, non-interventional observational     study in subjects, at least 18 years old, diagnosed with late-onset Pompe disease     prospectively collects data to understand clinical progression in terms of respiratory     function, symptomology, genotype, biochemistry, endurance and selected subject-reported     measures for 24 weeks followed by a 240 week additional observation period for up to 100     subjects.   "
81334|NCT02221349|"     This study will compare the safety and effectiveness of normal oral hygiene with two     different marketed dentifrices, on longer term dentinal hypersensitivity response following     use of potassium oxalate desensitizers.   "
81335|NCT02221336|"     Bipolar disorder is associated with a high risk of relapse and hospitalisation and many     patients do not recover to their previous psychosocial function. Major reasons for poor     outcomes are delayed intervention for prodromal depressive and manic symptoms as well as     decreased adherence with treatment.      Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a     smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled     trial, to test the effect of daily reporting of subjective self-monitoring of depressive and     manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.      In the MONARCA II trial the investigators will develop and deploy a new version of the     smartphone based monitoring system. The investigators will in a randomized controlled single     blind trial investigate whether daily electronic monitoring of subjective and objective     measures of illness activity using a smartphone based self-monitoring system including     feedback on subjective as well as automatically generated objective data (e.g.social     activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive     and manic symptoms and improves functioning more than a control group receiving a smartphone.     All patients will be followed for 9 months with outcome assessments at baseline, after 4     weeks, after 3 months, after 6 months and after 9 months.   "
81338|NCT02221297|"     Purpose of the study is to determine the effect of the investigational products as consumed     with a meal on serum lipids, primarily on LDL cholesterol.   "
81607|NCT02217787|"     This study has been designed to investigate the effect of high fat food on the     pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.   "
81339|NCT02221284|"     The purpose of this survey is to evaluate the safety and efficacy of long-term use of     alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate     response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin     secretagogues)* in addition to dietary/exercise therapy in daily medical practice.      * Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors,     thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use     surveys for Nesina Tablets.   "
81340|NCT02221271|"     Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic     criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not     conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin)     400mg/kg/day for five consecutive days.      Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse     events by the start of the study treatment.   "
81341|NCT02221258|"     The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to     severe rheumatoid arthritis after infusion.   "
81342|NCT02221245|"     Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out     normal cells, causing morbidity and ultimately mortality. the cancer stem cell theory     suggests that most tumors undergo a process of differentiation through which a relatively     rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of     cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result     of this cellular diversity, one or more cells within the tumor are likely to be resistant to     therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key     feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the     original intervention. The cellular programs driving the uncontrolled proliferation of many     solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in     esc. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs     will be effective in the treatment of cancer. The investigator's research program focuses on     the elucidation of signaling mechanisms, control of cellular processes and discovery of small     molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental     to CSCs. Our preliminary results identified a novel Notch associated protein NACK that     functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human     solid tumors and is required for cell survival and tumor growth in notch -dependent tumor     cells.      The investigator's aim is to further interrogate the link between Notch and Nack.      Specific Aims:        -  Identify and isolate the cancer stem cell populations from primary chemo naive          esophageal tumor samples.        -  Interrogate the status of the Notch,( the link between Notch and Nack), Wnt and Hedghog          pathways in the chemo naive esophageal tumor as well as in specific cell populations,          such as the CSC.        -  Determine the degree of cross-talk between these pathways and which of these pathways is          essential for the self renewal properties and tumorigenic properties of the esc          population.        -  Identify critical targets for therapeutic intervention in CSC populations.   "
81343|NCT02221232|"     The purpose of this pilot study is to evaluate antimicrobial properties of a single test     product, a vehicle product and a reference product applied in two different areas when used     as a patient preoperative skin preparation.   "
81362|NCT02220985|"     This phase II trial studies how well selective T cell depletion works in preventing     graft-versus-host disease (GVHD) in patients with acute lymphocytic leukemia, acute myeloid     leukemia, or chronic myelogenous leukemia undergoing donor peripheral blood stem cell     transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood     stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor     are infused into the patient they may help the patient's bone marrow make stem cells, red     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor     can make an immune response against the body's normal cells. Removing a subset of the T cells     from the donor cells before transplant may stop this from happening.   "
81440|NCT02219971|"     The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single     intravenous injection Kukoamine B Mesilate in health volunteer   "
81344|NCT02221219|"     Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions     that commonly occur in preterm infants and are well-recognized major contributors to     long-term brain injury and related disabilities later in life. Despite its prevalence, long     term consequences, and enormous medical and social costs, mechanisms of IVH and optimal     strategies to prevent or treat its occurrence are poorly defined, especially for extremely     premature infants. Only one medical therapy, prophylactic indomethacin during the first 3     days of life, has been shown to prevent or decrease the severity of IVH in preterm infants,     but its use is limited by toxic side effects and debatable effects on long-term outcomes.     Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may     also decrease the incidence of IVH in premature infants, but thus far these trials have     indomethacin treatment mixed within their cord clamping protocols. The investigators are     conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no     intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of     DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity,     neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in     extreme prematurity births and clear links of IVH to long-term disabilities there is a need     to improve care for these patients. This multi- disciplinary project addresses an important     medical problem for an understudied patient population, where the current practice has clear     limitations.   "
81345|NCT02221206|"     The intended study is designed as a prospective randomized controlled trial (RCT), comparing     and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum     anchorage by retracting the maxillary incisors.   "
81346|NCT02221193|"     Objectives: To determine whether site-specific mouth rinsing with oral disinfectants can     improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by     targeting specifically oral malodor implicate anaerobic bacteria.      Methods: Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive     correlational crossover cross-section clinical trial conduct during the month of Ramadan in     the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia     involving the application of Listerine® Cool Mint® mouth rinse by either the traditional     panoral rinsing method or a site-specific disinfection method targeting the subgingival and     supragingival plaque and the posterior third of the tongue dorsum while avoiding the     remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial     counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor and the     tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.   "
81347|NCT02221180|"     The purpose of this study is to evaluate the bioequivalence of metformin component of the     canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet     compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and     fasted participants.   "
81348|NCT02221167|"     This study is a randomized controlled trial seeking to determine whether supplementing     infants at risk for excessive neonatal weight loss with a small volume of human donor milk     prophylactically in the first 1-3 days of life, before maternal mature milk production     (before mom's milk comes in) will decrease the incidence of formula use at 1 week and 1, 2,     and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk     population.      We hypothesize that supplementation of term infants who have lost greater than or equal to 5%     birth weight by 36 hours of age with a small volume of donor breast milk following feeds,     until mature milk production, will result in decreased supplemental formula use at 1 week and     increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This     study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive     breastfeeding with offering early small-volume donor milk supplementation in a population of     infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence     of formula supplementation at 1 week of life and 2) improving breastfeeding duration.   "
81349|NCT02221154|"     The original mechanism of action of myo-inositol and preliminary results available in the     literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the     risk of OHSS in PCOS patients.      The aim of the study is to demonstrate that administration of myo-inositol decreases the     incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS     supported in IVF patients.   "
81350|NCT02221141|"     The purpose of this study is to determine the prevalence in Belgium of Fabry disease in     patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to     determine in Fabry patients which was the most frequently initial symptom.      Actually the early diagnosis is important because a treatment exists that can prevent future     complications.   "
81351|NCT02221128|"     A prospective, single centre, single arm study designed to collect clinical data on PerClot     when used in subjects undergoing endoscopic sinus surgery.   "
81352|NCT02221115|"     Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential     video/picture recording using the Google Glass device during their visit with the orthopaedic     surgeon or resident.      The investigators want to record the patient's level of acceptance and response to this new     technology. There are two arms: Patients seen by a doctor wearing the Google Glass device and     those that will not be exposed. Both groups will be asked to complete a survey after their     clinic visit.      The device users (doctor) will complete a survey which will evaluate how effective this new     tool is in the Orthopaedic clinical setting.   "
81353|NCT02221102|"     Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent     stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and     slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral     anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying     significantly less risk of intracranial hemorrhage.      This trial is a randomized, double-blind, multicenter, controlled clinical trial in China.     The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to     aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular     event.   "
81363|NCT02220972|"     This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to     evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled     partial onset seizures (on an antiepileptic drug [AED] monotherapy) who are experiencing     sleep onset insomnia.   "
81354|NCT02221089|"     Oxidative stress has been implicated to play a pathogenic role in many disease processes,     especially in age-related disorders such as age-related macular degeneration. It has been     hypothesized that antioxidative agents such as vitamins and minerals, which are capable of     scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for     patients with age-related disorders. Based on this hypothesis several different combinations     of vitamins have been introduced, all targeting at reducing oxidative stress. However, the     in-vivo effect of the antioxidative properties of a certain drug or vitamin combination is     hard to investigate. In the current study, we propose to investigate the effect of Retaron®,     a combination of carotoinoids, omega-3-fatty acids, a herbal extract of Aronia, vitamins and     trace elements, in a systemic in-vivo inflammation model.      In the present study, the infusion of LPS, which is a cell wall component of gram-negative     bacteria and a major mediator in the pathogenesis of septic shock, will be used as a     standardized experimental model of systemic inflammation in humans. Given that inflammation     is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS     model is well suitable for determination of the antioxidative effects of Retaron®. As a main     outcome parameter the vascular reactivity of retinal vessels to systemic hyperoxia (induced     by breathing 100% oxygen) will be tested in presence or absence of the antioxidant     combination.   "
81355|NCT02221076|"     The protocol aims at demonstrating the technical feasibility and safety of doing     endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and     needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and     surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all     pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.   "
81356|NCT02221063|"     The purpose of this study is to determine whether consumption of thiamin fortified fish sauce     over 6 months increases the thiamin status of women to a level consistent with a low risk of     infantile beriberi. The investigators hypothesize that consumption of thiamin-fortified fish     sauce will increase red blood cell thiamin concentrations, an indicator of thiamin status, in     women consuming thiamin-fortified fish sauce, while concentrations will not change in women     consuming a placebo fish sauce that does not contain thiamin.   "
81357|NCT02221050|"     A study conducted in the laboratory revealed the existence of a window during which     patients with renal failure appreciate the protein-rich foods. This period, located     immediately after the dialysis, is likely related to the purification of plasma products     resulting from protein catabolism. It therefore appears necessary to understand the     mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone),     leptin (anorectic hormone) and plasma amino acids.   "
84141|NCT02184663|"     Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for     patients with unresectable pancreatic cancer.      Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such     population   "
81358|NCT02221037|"     Lung injury in patients undergoing oesophagectomy may occur during surgery (peri-operatively)     as a result of One Lung Ventilation (OLV) and/or during the immediate post-operative period     when patients receive intensive care. This is reinforced by the observation that     physiological markers of lung injury are most elevated immediately after completion of     surgery, and the development of clinical Acute Respiratory Distress Syndrome (ARDS)occurs     immediately post-operatively (within 72 hours of surgery), with the majority of cases     reported 24-48 hours after completion of surgery. This study is designed to investigate the     impact of pre-operative administration of GSK2862277 on biological and physiological markers     of lung injury in patients undergoing surgical resection of oesophageal cancer in order to     achieve optimal exposure at the site of injury following OLV and lung deflation. This study     is a randomized placebo controlled, double-blind, multi-centre, single dose parallel group,     design. There will be two treatment groups comprising one active and one placebo arm with     approximately 40 patients per group. Patients enrolled in the study will be scheduled to     undergo planned/elective trans-thoracic surgery for oesophagectomy. The primary endpoint for     this study is the change in pulmonary vascular permeability index (PVPI) from pre-surgical     levels to the end of surgery. GSK2862277 will be administered as an orally inhaled aerosol     (single nebulized dose) over approximately 3 to 5 minutes (min) 1-3 hours prior to surgery.     Subject will be monitored daily until discharge and followed up till day 28.   "
81359|NCT02221024|"     Children admitted in a ward often require a peripheral intravenous catheter to provide access     for administration of medications, nutrients, fluids, blood products. Vascular access in     children is a frequent and stressful procedure that should be performed as infrequently as     possible in order to reduce the child's pain experience and the child's and family's level of     distress. The maintenance of patency of indwelling catheters is therefore relevant to     minimize need for replacement and children discomfort.      Recent studies investigated the most effective and safe method of maintaining peripheral     intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the     use of heparin versus saline flushes, showing similar efficacy of the two approaches.      To the best of the investigators knowledge no study addressed the issue of the optimal     flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of     normal saline flushes, at 12 and 24 hours intervals.   "
81360|NCT02221011|"     The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has     been used to treat the spasticity with expressively response and the effect could persist for     1-3 months in different studies. However most sutdies lack the sham or control group. The     purpose of this study was to assess the effect of shock wave for spasticity in wrist and     hand.   "
81361|NCT02220998|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks     compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants     with chronic genotype 2 hepatitis C virus (HCV) infection.   "
81364|NCT02220959|"     the purpose of this study is to determine if 60 meter test done prior to surgery is a     predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.   "
81365|NCT02220946|"     vaginal electrical stimulation improves female sexual dysfunction   "
81366|NCT02220933|"     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the     disability of patients suffering from progressive multiple sclerosis and especially those     with gait impairment.   "
81367|NCT02220920|"     The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284)     in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.   "
81369|NCT02220894|"     In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small     cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to     35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel     or carboplatin + pemetrexed for 4 to 6 21-day cycles). Participants on the platinum-based     chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance     therapy after the 4 to 6 cycles of chemotherapy. The primary study hypothesis is that     pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy.   "
81370|NCT02220881|"     The primary objective of this study is to investigate the effectiveness of mold making     silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to     determine the compliance of mold making silicone toe separator, the change in pain level and,     including, the satisfaction of the participants after using mold making silicone toe     separator.   "
81371|NCT02220868|"     The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the     treatment of hepatitis c in patients taking stribild.   "
81372|NCT02220855|"     Thymic tumors are rare tumors, but represent the most common tumors of the anterior     mediastinum. Thymoma has an indolent course in advanced disease and has the propensity to     spread to the pleura. In first line therapy, combination chemotherapy produces responses in     approximately 80% of patients. A number of single agents have activity in recurrent disease,     but none are curable. Patients with recurrent thymoma have limited treatment options, and     thus novel target modalities are needed.      At the Indiana University Simon Cancer Center (IUSCC), more patients with advance thymoma are     seen than any other institution in the country. Our main hypothesis is the PI3K pathway is an     important driver for growth and metastasis of thymoma and that inhibition of the PI3K pathway     is expected to produce clinically meaningful response in patients with recurrent thymoma.   "
81373|NCT02220842|"     This open-label, multicenter, global study is designed to assess the safety, tolerability,     preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and     obinutuzumab in participants with refractory or relapsed follicular lymphoma (FL) or     atezolizumab and obinutuzumab or tazemetostat administered in participants with refractory or     relapsed diffuse large B-cell lymphoma (DLBCL). The anticipated duration of this study is     approximately 4.5 years.   "
81384|NCT02220699|"     All Danish general practices have a data capture system that collects selected data from the     electronic patient record. These data are used for various quality assurance purposes. The     aim of the study is to evaluate the quality assurance system/program that identifies patients     having an increased risk of osteoporosis.   "
81374|NCT02220829|"     Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop     symptomatic urinary problems .These symptoms can significantly diminish a patient's quality     of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease     resistance to urinary flow.      This multi-institutional phase III trial is designed to compare standard of care versus     preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group,     whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across     Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy     or if/when symptoms appear.   "
81375|NCT02220816|"     Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6     months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of     competitive versus non-competitive attentional training. Competitive training will include     fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations     and fifteen 1-hour sessions of competitive attentional games designed for this purpose using     a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED     array to facilitate multi-touch experience embedded in a conventional table). Progress will     be evaluated by pre and post measurement of attentional neuropsychological tests, subjective     reports of global attention, usability and motivational scales. Our hypothesis is that     competitive training is more effective in improving attention than conventional training in     the chronic phase after acquired brain injury.   "
81376|NCT02220803|"     This is a short term open, randomized cross over trial to explore and compare the efficacy of     pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA) related     hypertension. Patients will be randomized to receive Acetazolamide(Diamox®)(ACZ), Continuous     Positive Airway Pressure (CPAP)or CPAP plus ACZ for 2 weeks. Following a 2 week wash-out     period all study participants will receive the alternative treatment regimen. The total     length of the study will be 10 weeks. The effects of carbonic anhydrase inhibition on blood     pressure,hemodynamics and sleep apnea will be investigated.      Study hypothesis:      Carbonic anhydrase inhibition alone or in combination with nCPAP will prominently reduce     blood pressure in patients with OSA. Further it is hypothesized that CA inhibition will     induce a direct pharmacological effects on vascular stiffness as evidenced in overnight     non-invasive assessments of vascular stiffness and that this effect will be particularly     strong in patients also responding with a reduction of blood pressure.   "
81377|NCT02220790|"     The purpose of the study is to 1) define the operating characteristics of fungal biomarker     assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine     the change in fungal biomarker assay results in children who develop invasive candidiasis,     and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive     candidiasis and those with invasive candidiasis for future testing of fungal biomarker assays     and development of new fungal biomarker assays. The study will assemble a prospective cohort     of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for     biomarker testing will be obtained at the time a patient has a clinical indication for blood     culture attainment. Additional blood sampling will be performed on the sub-set of patients     that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and NPV of     biomarker assays will be determined for each biomarker assay. No PHI will be stored in the     database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.   "
81378|NCT02220777|"     This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses     of ASP8477 or a placebo under fasted conditions in postmenopausal subjects. Part II is     similar to part I except that the study is conducted in young, vasectomized males.      Part III assesses the effect of food (fed or fasted conditions) on ASP8477 in postmenopausal     subjects.      Part IV assesses the drug-drug interaction between ASP8477 and omeprazole in postmenopausal     subjects.   "
81471|NCT02219568|"     The purpose of this study is to compare the efficacy between video capsule endoscopy and CT     enterography in diagnosis of obscure gastrointestinal bleeding.   "
81379|NCT02220764|"     The objective of this prospective clinical study is to investigate the differences in the     complication rates between tooth- and implant- supported zirconia based fixed dental     prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference     in the complication rates between implant- supported and tooth- supported zirconia FDPs.   "
81380|NCT02220751|"     The purpose of the study was to monitor the activity of periodontal disease and suggest     potential biomarkers related to active periodontal disease in patients with chronic     periodontitis (PD) associated or not with type 2 diabetes mellitus (DM), based on the     evaluation of the profile of gene expression of periodontal sites and the evaluation of     inflammatory salivary proteins. Two hundred and five periodontal patients were enrolled, but     only 41 exhibited ≥ 1 mm attachment loss in at least three periodontal site (active sites) 2     months after non-surgical periodontal therapy. The final sample was: 21 patients with chronic     periodontitis (PD group) and 20 with chronic periodontitis and diabetes (PD+DM group).     Fifteen periodontal- and systemically healthy patients were included as control group. Saliva     collection, glycated hemoglobin measurement, periodontal examination and radiographs were     conducted before and 2 months after non-surgical periodontal therapy. Radiographic     subtraction was performed from pairs of the radiographs. Measurements of the areas with     density loss were recorded. Gingival biopsies of active and non-active sites with similar     clinical parameters were harvested for Real Time Polymerase Chain Reaction Array gene     expression analysis. Saliva samples were analyzed by Multiplex Cytokine Profiling Immunoassay     for analysis of protein expression. The clinical attachment loss mean was higher in the PD+DM     group (p<0.05). There was a high correlation between clinical attachment loss and darkened     radiographic areas in active sites of the PD group and PD+DM group. When compared PD group to     PD+DM, patients with diabetes had an up-regulated profile. Active sites of the PD group     showed nine genes (specific chemokines, interleukins and receptors) differentially expressed     with an up-regulated profile. Active sites of the PD+DM group showed six genes (specific     chemokines, interleukins and receptors) differentially expressed with an up-regulated     profile. After periodontal therapy, there was a reduction of some salivary proteins in both     periodontal groups, but not significant. In conclusion, it was possible to identify genes     differentially expressed in active sites from both groups, which may be considered useful in     indicating potential biomarkers for the diagnosis of periodontitis; salivary proteins show a     trend in distinguishing the standard of health and disease and may be used in the future as     potential biomarkers of periodontitis with or without diabetes.   "
81381|NCT02220738|"     This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple     doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.   "
81382|NCT02220725|"     The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the     anticoagulation effect of Rivaroxaban.   "
81383|NCT02220712|"     To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot     formulation in patients with schizophrenia after repeated administration by injection into     the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals   "
81413|NCT02220322|"     Age-related change of femur is not well-known. The investigators investigated the     longitudinal changes of femur.   "
81385|NCT02220686|"     The purpose of the study is to see if vascular physicians (your provider) using a combination     of proven smoking cessation tools in an organized way can help vascular patients quit smoking     better than usual.      The doctors where you are being treated have been chosen to either provide:      the combination therapy of giving you advice, considering prescribing medications to help you     quit smoking, and referring you to a phone quitline, or to continue their usual smoking     cessation practices (which may include all, some, or none of the treatments above).   "
81386|NCT02220673|"     Primary objective: To investigate the safety and local tolerability of increasing cumulative     doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT     administered via oral inhalation with the Respimat® inhaler B (RMT-B) vs. 2 inhalation     solutions without BHT (placebo to BHT given by RMT B and placebo given by hydroxylfluoralkane     metered dose inhaler (HFA MDI)). In a first step, the trial was performed in healthy subjects     and - if no safety concerns arose - in a second step in patients with mild asthma who were     sensitive to metacholine in a respective challenge test. Secondary objective: To explore the     pharmacokinetics (PK) of BHT.   "
81387|NCT02220660|"     The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD     1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following     inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic     solution for inhalation, EIS) with the systemic exposure following inhalation of the free     dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX     (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS     and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to     compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903     XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after     a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed     dose combination and the free dose combination, respectively; to compare the safety and     tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed     dose combination and as the free dose combination, respectively.   "
81388|NCT02220647|"     Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose     combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850     mg administered together   "
81389|NCT02220634|"     The purpose of this study is to see if Regadenoson may offer improved ease of use, single     dose administration, and better tolerance for testing for pulmonary hypertension than iNO.     You will be screened to make sure Regadenoson is safe for you with a clinical evaluation,     blood tests, and an ECG.   "
81390|NCT02220621|"     Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of     myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as     symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual     abortion, which seriously affect the patients quality of life.      Preventing IUA has been tried using different methods such as barrier or stent in order to     separate the opposing endometrium during the tissue healing processes. Although some     successes have been reported there are still some challenges need to be dealt with.      One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a     natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound     repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA     in clinical studies.      A novel self-crosslinked HA gel is developed by BioRegen Biomedical（Changzhou）Co., Ltd with     proprietary technologies. This product is a highly viscoelastic crosslinked gel that     overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation     in vivo. For this product, the results of animal experiments and various safety features have     been designed and tested conforming to the national regulations and standards. In order to     launch this product to the market, this prospective, randomized and controlled clinical trial     is designed and will be performed to verify its safety/efficacy.   "
81393|NCT02220582|"     The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective,     multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at     contextual risk factors and novel predictors of hard events over a period of four years.      The unique features of this initiative are:        -  MRI as the sole imaging technique (including the use of a mobile MRI machine)        -  Contextual factor analysis (including community environmental profile assessments)        -  Record linkage follow-up of individuals to health services (administrative) databases          for major morbidity and mortality events and health services utilization   "
81394|NCT02220569|"     PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving     chemotherapy early on in order to avoid irreversible damage. In addition to that, we will     test if the PhysioFlow is non-inferior to the conventional MUGA scan.   "
81395|NCT02220556|"     Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral     type. Up to 50 patient can be included into each cohort.   "
81396|NCT02220543|"     The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new     primary care intervention Back on Track as compared to usual primary care in patients with     non-specific chronic low back pain in which disability levels are moderate and the role of     psychosocial factors to this disability is at maximum low (classified as WPN2).   "
81397|NCT02220530|"     This study aims to assess the impact of the use of sedation on the overall quality of the     colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific     and technical quality, perceived quality and safety.   "
81398|NCT02220517|"     The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with     additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more     prostate cancers than targeted MR-guided in-bore prostate.   "
81399|NCT02220504|"     This open-label, non-randomized, prospective study will evaluate the risk of symptoms     recurrence during the three years after antipsychotic discontinuation in a sample of     functionally recovered first-episode patients with schizophrenia spectrum disorder.   "
81608|NCT02217774|"     The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS),     consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by     evaluating the difference between planned and actual implant positions on pre- and     post-operative CBCTs.   "
81400|NCT02220491|"     Patients with brain metastases with expected life expectancy of 3-6 months are typically     treated with radiotherapy to the whole brain giving a dose of 20 Gy over a 5 day period. This     study will compare this with volumetric modulated arc therapy (VMAT) which is capable of     delivering 15 Gy in one single session to identified disease within the brain but sparing the     normal surrounding brain tissue. Primarily the study will assess whether it is possible to     recruit sufficient patient numbers to a trial of this type. It will also compare     effectiveness, side effects and quality of life between the two treatment methods.   "
81401|NCT02220478|"     The primary purpose of this pilot study is to evaluate the accuracy of cup placement between     two instrumentation technologies: Cutting Guide and Conventional Instrumentation.   "
81402|NCT02220465|"     The study's primary aim is to test the hypothesis that an intervention that integrates low to     moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA)     will result is greater reductions in quit-day reactivity to smoking cues (a behavioral     predictor of smoking relapse) as compared to standard care smoking cessation counseling     (control group) in a sample of low-income sedentary male and female smokers. The study will     also test the hypothesis that the participants randomized to the LMPA intervention will have     greater quit rates at one-week and one-month post quit day follow ups.   "
81403|NCT02220452|"     -  The perioperative period can be a significant source of psychological burden, anxiety          and fear for patients        -  Both pharmacological and non-pharmacological methods have been proposed in order to          alleviate perioperative stress        -  Music is one of the non-pharmacological methods which have been used in this context,          with favorable effects both preoperatively and postoperatively        -  The attenuation of perioperative stress through music listening is probably due to the          activation of emotional and cognitive processes that evoke feeling of pleasure and can          distract patients' attention from fear and unpleasant thoughts related to the surgical          procedure        -  Little information is available regarding the effect of intraoperative music listening          on anesthetized, unconscious patients        -  There is a notion that general anesthesia does not completely abolish auditory          perception and that some processing of intraoperative events can occur in unconscious          patients, even in the absence of postoperative recall        -  The investigators hypothesis is that intraoperative music listening can decrease          anesthetic requirements and reduce sevoflurane consumption in female patients subjected          to abdominal hysterectomy for benign disease.   "
81404|NCT02220439|"     This is a proposal for a nested case‐control study within an ongoing rotavirus vaccine     immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the     fecal microbiota composition and diversity of infants who do (control) and do not (case)     demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for     vaccination dose, age and breast‐feeding practices.   "
81405|NCT02220426|"     The primary goal of this study is to evaluate the feasibility of detecting Brown Adipose     Tissue (BAT) in healthy subjects by using hyperpolarized xenon gas MRI.      In this pilot study, MRI of BAT of healthy adult volunteers will be performed at 3 Tesla to     assess image quality using a prototype surface coil and pulse sequence following inhalation     of hyperpolarized 129Xe (xenon) gas at thermoneutrality and under mild cold condition.      The investigators are testing the abilities of xenon MRI to see brown adipose tissue and     detect its thermogenic activity.   "
81406|NCT02220413|"     The purpose of this study is to investigate what proportion of obese women will have a     self-reported delay in lactogenesis II (breastmilk coming in) compared to women with a     normal weight. We hypothesize that obese women will have an absolute 20% increase in delayed     lactogenesis II.      We will compare two group of women for delayed lactogenesis II, one group with obese women     (BMI>30) and one group of women with a normal weight (BMI<30).      The secondary objective is to assess what other factors influence the self-reported delayed     lactogenesis II.   "
81407|NCT02220400|"     Previous study demonstrated that neuroinflammation induced by surgery is the main cause of     the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved     to be an anti-inflammation agent. In present study investigators hypothesized that low dose     ketamine would prevent the cognition decline after orthopedic surgery in aged patients.   "
81408|NCT02220387|"     The objective of this study is to investigate molecular, cytological and genetic features of     occupational chronic obstructive pulmonary disease (COPD) in conditions of different     occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and     standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar     lavage and associations of single nucleotide polymorphisms (SNPs) rs1800470 transforming     growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene,     rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3     (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic     aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and     phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein     (hsCRP) and tumor necrosis factor-α (TNF α) serum concentration, in different occupational     COPD groups will be studied. The hypothesis is that the mechanisms underlying disease     development and progression are different due to environmental risk factor that reflex in     differs in disease attributes - molecular biomarkers, cytology results and genetic     susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore     COPD can be subdivided into ecological phenotypes according to environmental risk factor.   "
81410|NCT02220361|"     Hemabate is often used for gynecological patients. Hemabate is associated with many side     effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is     reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period.     We design this clinical trial to find if dexmedetomidine can prevent the side effects of     hemabate in Cesarean Section patients.   "
81411|NCT02220348|"     The purpose of this study is to determine the amount of linaclotide and its active metabolite     (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (145 μg     or 290 μg) in lactating women receiving the drug therapeutically.   "
81412|NCT02220335|"     A number of 100 patients with pulmonary arterial hypertension associated with the left Heart     failure scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to     either PADN or control group.   "
81414|NCT02220309|"     This research study is aimed at understanding behaviors and brain circuits that relate to     anxiety and depression. Our goal is to learn which circuits of the brain are involved in     anxiety and how these circuits might affect daily functioning.      This study has recently added an additional treatment component: participants undergo a 12     week course of either Pramipexole medication or rTMS therapy (explained below). The ultimate     goal of the study is to offer participants experiencing anxiety and depression a treatment     that is alternative to ones that have failed them in the past, and to apply the knowledge we     gain from investigating the brain circuits involved in anxiety and depression to help     personalize treatments.      We invite anyone who has recently experienced any symptoms of anxiety and/or depression to     participate (no diagnosis is required to participate).   "
81415|NCT02220296|"     This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a     range of single doses of subcutaneous insulin 338.   "
81416|NCT02220283|"     Compare the renal complication of endovascular and open repair of acute aortic dissection by     including patient treated at NTUH in 2010~2013.   "
81417|NCT02220270|"     The purpose of this study is to determine the safety, performance and efficacy of the     Hyperion™ Occluder Systems during treatment of ASD and PDA patients.   "
81418|NCT02220257|"     Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets     of Langerhans in the pancreas. Symptoms of diabetes present when the mass of     insulin-producing cells reaches a point where insulin concentration does not suffice to     maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of     diabetes and initiation of insulin therapy. This phenomenon is called a remission.      The aim of this study is to asses the influence of occurrence and duration of remission on     development of chronic complications of diabetes and patients outcome.   "
81419|NCT02220244|"     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the     visual improvement of patients suffering from chronic visual loss resulting from multiple     sclerosis related optic neuritis.   "
81420|NCT02220231|"     Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for     excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with     one-lung ventilation during VATET may cause hemodynamic instability due to the compression of     intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax     on the pulmonary blood flow and cardiac function during the VATET by using the     transesophageal echocardiography.   "
81421|NCT02220218|"     The purpose of this study to evaluate the bioequivalence (is the amount same in both the     pills) of metformin component of the canagliflozin and metformin immediate release (IR) fixed     dose combination (FDC) tablet compared with the metformin IR tablet co-administered with     canagliflozin tablet in healthy fed and fasted participants.   "
81620|NCT02217618|"     The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to     determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of     the drug after the dose. This study will last approximately 28 days, not including screening.     Screening can occur within 30 days prior to the start of the study.   "
81422|NCT02220205|"     Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In     order to make them accessible to women, health care providers must be trained to insert them.     Physicians, physician assistant, and nurse practitioners often learn how to do so by first     learning about IUDs, then practicing on a model that the IUD manufacturer provides.      Educators have recently been using more sophisticated models to teach clinical skills such as     surgical procedures. We are investigating whether these models may be more useful in teaching     IUD insertion.   "
81423|NCT02220192|"     This is a pilot study to test the short-term effectiveness of an alternative treatment     approach for precancerous cells of the cervix. The study will also explore whether this new     treatment is feasible to perform and if it is acceptable to patients.   "
81424|NCT02220179|"     In this project we invite 9.000 children and young persons in Denmark and their foster     parents and staff at the residential institutions to participate in a cluster randomized     controlled intervention study where we aim to test the effectiveness of a web based knowledge     and inspiration program about resilience for children, adolescents and adults (called     myresilience.org). The complete CONSORT trial protocol is available at     http://myresilience.org/ at the subsite 'about us'.   "
81425|NCT02220166|"     Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat)     have provided conflicting results with some in vitro and ex vivo studies consistent with non     toxicity and other suggestive of toxicity. We recently reported results of a single     administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while     assessing symptoms and changes of intestinal permeability. Although results of intestinal     permeability were inconclusive Tm, but not other type of gluten, was clinically well     tolerated.      The aim of the present study was to assess safety of 60 days of administration of Tm (100     grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on     clinical, serological and histological parameters in Celiac Disease patients on remission     after 1 year of GFD.   "
81426|NCT02220153|"     This study is designed to evaluate the safety and tolerability of single ascending doses of     UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.   "
81427|NCT02220140|"     In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a     randomized controlled intervention study where we aim to test the effectiveness of a web     based knowledge and inspiration program about resilience for children, adolescents and adults     (called myresilience.org). The complete CONSORT trial protocol is available at     http://myresilience.org/ at the subsite 'about us'.   "
81442|NCT02219945|"     Electronic noses detecting patterns of volatile molecules have recently been introduced for     different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins     et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%.     Here the investigators test a production type point-of-care hand-held device with less     detectors. The investigators explore factors such as food intake, smoking, and co-morbidity,     as well as the impact of TB treatment, and address the question whether the device could help     monitor disease and response to treatment.   "
81428|NCT02220127|"     Gamma Knife Radiosurgery (GKR) is a well-established treatment modality for brain metastasis     (Chiou 2013; Salvetti, Nagaraja et al. 2013). Large multicentre series have been published on     patients with single and multiple cerebral metastases, treated with GKR over a period of 30     years (Karlsson, Hanssens et al. 2009). Multiple institutions have reported a consistently     high local tumour control rate of 80%-90% following GKR (Chang, Lee et al. 2000; Da Silva,     Nagayama et al. 2009; Salvetti, Nagaraja et al. 2013).      There is controversy over the use of GKR and/or Whole Brain Radiotherapy (WBRT) in patients     with multiple metastases. WBRT provides a lower rate of distant recurrences, whereas GKR     achieves good local control of treated lesions without the deleterious side effects of     radiotherapy (Lippitz, Lindquist et al. 2014). This discussion is mainly focused on the risk     of distant recurrences, which is lower if WBRT is given. There is evidence showing that     Radiosurgery (RS) based on high contrast/resolution stereotactic MRI decreases the incidence     and lengthens the time to distant recurrences (Hanssens, Karlsson et al. 2011). As a result,     the current tendency is to treat all the lesions visible in high contrast/resolution images     the day of Gamma Knife; which is followed by regular MRI follow ups and subsequent GKR for     distant recurrences in order to avoid/delay WBRT.      It has been estimated that more than a half of distant recurrences will grow from tumour     cells that were already in the brain (as micrometastases) when radiosurgery is delivered, but     not much has been studied on the optimal prescription and radiation delivery method for these     lesions. There is controversy over which collimator should be used when treating     micro-metastases (BmM). These lesions can either be treated with the 4mm collimator at an     isodose between the 40% and 90%, or the 8mm collimator at an isodose above 90%. The 8 mm     collimator is thought to offer better Local Control Rate (LCR) with the advantage of faster     delivered treatments, while the 4 mm collimator is considered to be safer, given its steep     dose fall-off. It is the aim of this study to find out which of the 4 mm or 8 mm collimators     can achieve the higher LCR with less complications. A large number of lesions will be     randomised to either the 4 or the 8 mm collimator and the patients followed up to evaluate     clinical efficacy.   "
81429|NCT02220114|"     The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the     dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin     (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6     years) and 500 mg granules for oral solution sachets (for infants and children below 6     years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is     needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often     required.      This study is a descriptive, non-randomized, open label multi-centric acceptability study in     infants and children affected with infantile spasms. The primary objective is to describe the     adherence to the new formulation. Secondary objectives include:        -  evaluation of the palatability and user-friendliness of the new treatment,        -  evaluation of the pharmacokinetic parameters of the new formulation,        -  PK parameters,        -  evaluation of the tolerance,        -  measurement of taurine plasma levels. This study will recruit up to 40 patients with          infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23          clinical sites in France.   "
81430|NCT02220101|"     Comparison of four methods for measuring temperature perioperatively in patients scheduled     for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme;     Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner.     The study is a single-center, observational study carried out by the Central Surgical and     Intensive Section at Vestfold Hospital Trust.   "
81431|NCT02220088|"     Transarterial chemoembolization (TACE) is considered the gold standard for treating     intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not     specify the criteria for repeating TACE.The study,conducted in Europe ，recently published in     the journal of Hepatology shows the ART score of >=2.5 prior the second TACE identifies     patients with a dismal prognosis who may not profit from further TACE sessions. However,in     clinical practice，we also found some patients who showed TACE-resistant at the beginning of     treatment may access to get objective response of retreatment with TACE.So the investigators     conduct this prospective,randomized controlled study to find out whether the patient who     showed TACE-resistant can obtain survival benefit from retreatment with TACE.   "
81621|NCT02217605|"     The purpose of this study is to determine the effects of an oral fructose challenge on liver     adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a     potential measure measure of liver health.   "
81432|NCT02220075|"     LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of     LMA insertion. When the investigators evaluate the LMA position, the investigators can use     fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway     pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will     bring high risk of aspiration. Recent studies reported the LMA position after general     anesthesia induction not after operation. Therefore, the investigators will observe the LMA     position three times; after general anesthesia induction, after caudal block, and after     operation as well as the difference regarding to spontaneous and controlled ventilation.   "
81433|NCT02220062|"     Pancreatic cancer related pain can be difficult to control, even with high doses of     narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic     ultrasound guided celiac plexus neurolysis) is well established as an effective technique for     controlling pain and reducing narcotic requirements in patients with pancreatic cancer.     Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it     allows for direct injection into individual celiac ganglia to perform celiac ganglia     neurolysis. This more precise delivery of therapeutic drug will offers the potential for     enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial     aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac     ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus     neurolysis) in providing relief from pancreas cancer-related pain.   "
81443|NCT02219932|"     The primary objective is to determine whether prolonged-release fampridine (10 mg twice     daily) has a clinically meaningful effect on participant-reported walking ability over a     24-week study period.      The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken     twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical     impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period;     to evaluate criteria for early assessment of response to fampridine that can predict     clinically meaningful benefits in walking ability and balance; to assess the safety and     tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment     period.   "
81609|NCT02217761|"     The purpose of this study is to investigate the factors influencing pharmacokinetic and     pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.   "
81610|NCT02217748|"     The objective of our study was to determine the extent to which the order of specific items     in a multiple name generator survey affects how social networks are measured.   "
81434|NCT02220049|"     VELCADE has demonstrated marked activity in haematological cancers leading to registration     (MM, MCL).      Currently only biweekly or weekly regimens have been explored. Key signalling pathways which     are aberrant in haematological cancers are also present in solid tumors.      VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as a     single agent & in combination with chemotherapy in solid cancers has shown modest and real     anti-tumor activity but insufficient for Phase III development.      VELCADE PK exposure may be inadequate in solid tumors compared to liquid cancers. VELCADE     daily low dose administration may allow a greater PK exposure to be achieved, which is     tolerated      Hypotheses:      VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses     VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S proteasome     inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD results in     improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially cross the     threshold required for clinically significant anti-tumor activity in solid cancers).      Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome     inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have     increased anti-tumor activity compared to monotherapy alone.   "
81435|NCT02220036|"     This is a double-blind randomized clinical trial which will start at June 2014 and end on     June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the     sample size calculated 80 persons (40 persons for control group and 40 persons for patient     group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood     Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular     Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium     supplement (250 milligram) and the other group will receive placebo which is similar to the     magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete     4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal     and inflammatory profiles will be measured at the beginning and end of the study as well as     anthropometric measurements.   "
81436|NCT02220023|"     The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and     pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with     pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on     invasive catheterization as well as healthy subjects. Measurements will also be made after     high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The     investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to     measure dynamic changes in RV-pulmonary vascular function in patients with     vasodilator-responsive PAH.   "
81437|NCT02220010|"     Dividing pancreas when performing left-sided resections opens the risk for leakage from the     divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding     abdominal tissues with abscess formation producing systemic inflammation and potential lethal     bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage     reduces healing time. A pancreatic stent could theoretically improve the drainage of     pancreatic juice into the duodenum and by this shorten the healing time still further.      Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not     shown a positive effect on fistula formation.      In an open randomized multicenter clinical trial we want to test the hypothesis that a     reduced fistula healing time, in left sided pancreatic resections, could be reduced by     introducing a pancreatic stent when on post operative day 3 or later a B och C fistula     (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by     randomizing between pancreatic stent with drains versus only drains.   "
81438|NCT02219997|"     The purpose of this study is to compare the reaction time (as measured by braking reaction     time in seconds during simulated driving) under glare and no-glare conditions in subjects     implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs.     This study will enroll subjects previously implanted with IOLs in both eyes for at least 3     months.   "
81439|NCT02219984|"     This is a phase 4 cohort prospective, open, national, multicentre study that collects data on     history of patients treated chronically with anticoagulant drugs, including the novel direct     oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and     is not intended to have any influence on the treatment of the single patients included.      Patients are included when they start the anticoagulant treatment, whatever the drug used, or     when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral     anticoagulants, provided that the therapy is expected to last at least 3 months.      The general aims of the study are to provide a better evaluation of efficacy and safety of     different treatment options, and to improve our understanding of the risks/benefits of the     various anticoagulant drugs and the different therapy options.      The Registry is open to the participation of clinical centres or individual professionals     (now called Participants) that are involved with management of anticoagulated patients.   "
81441|NCT02219958|"     Hypertension (HT) is one of the major cause of morbidity and among the top 10 causes of     deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has     initiated service improvement through introducing the risk assessment and management     programme (RAMP) to improve the quality of care (QOC) for HT patients in general outpatient     clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to     inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the     University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the     QOC of the programme.      The Action Learning and Audit Spiral methodologies to measure whether the target standard of     care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital     will be invited to complete a structured evaluation questionnaire. The data of all patients     who have enrolled into the RAMP for more than one year will be included in the evaluation on     the process and outcomes of care.      One thousand two hundred and forty-eight age and disease matched control patients who have     not been enrolled into the RAMP programme will be selected for the comparison in the outcomes     of care. A hundred and thirty participants will be followed up by telephone to evaluate the     effect of the programme in quality of life (QOL), patient enablement, and global rating of     change in health condition at baseline and 6 months after enrolment. Data on the process of     care will be retrieved from the HA medical records.      Main Outcome Measures: The primary outcomes are the proportion of participants who have     received the criterion process of care, and achieved the target blood pressure levels.      Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC     criteria will be calculated. The changes in the clinical and patient reported outcomes of     RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample     t-test. The clinical outcomes between RAMP subjects and control group will be compared by     independent sample t-test or Chi-square test.      Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible     areas for quality enhancement will be identified.      Conclusion: The results of this study will provide empirical evidence on whether the HA's     RAMP programme can achieve improvement in QOC for HT patients. The information will be used     to guide service planning and policy decision making.   "
81444|NCT02219919|"     This randomized clinical trial will investigate changes in pain intensity and nociceptive     gain processing after the application of either physical therapy or surgery in women with     carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain     intensity, widespread pressure pain sensitivity and segmental thermal changes after the     application of a physical therapy program based on desensitization maneuvers of the central     nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up     periods. We hypothesize that the physical therapy intervention targeted to desensitization of     the central nervous system is more effective than surgical intervention for modulating     altered nociceptive gain processing in women with CTS.   "
81445|NCT02219906|"     Metabolic syndrome is a group of risk factors that increase a patient's likelihood for heart     attack, stroke and diabetes. Our research is aimed at understanding whether a drug,     resveratrol, commonly found in grapes and red wine, would have any benefit in reducing risk     factors in patients that have metabolic syndrome. Despite the use of aspirin and cholesterol     reducing medications, patients with metabolic syndrome still often have sticky platelets and     dysfunctional lipid profile. This is likely due to inflammation and high oxidative state. In     animal studies, this drug has reduced platelet stickiness and reduced oxidative stress.     However, the effects of this drug have not been researched in patients with metabolic     syndrome.      We are interested in studying whether the benefits of resveratrol described in animal models     can be translated to patients with metabolic syndrome who display high markers of oxidative     stress. We plan to give a short intervention of drug to patients and then determine if the     drug successfully:        1. Decreases the stickiness of platelets. This is important because sticky platelets are          more likely to form clot and contribute to plaque formation.        2. Reduce the circulating dysfunctional HDL. HDL and its protein and lipid constituents          help to inhibit oxidation, inflammation, activation of the blood vessel wall,          coagulation, and platelet aggregation. Dysfunctional HDL, as occurs in metabolic          syndrome patients, cannot properly protect against atherosclerosis.   "
81446|NCT02219893|"     The purpose of this study is through a phase I/II clinical trial to assess the safety and     toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative     day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)     for peritoneal metastases from colorectal cancer (CRC).   "
81447|NCT02219880|"     The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised,     placebo-controlled study.   "
81448|NCT02219867|"     Ketamine has been safely used for induction and maintenance of anesthesia for decades and     more recently has been used for chronic pain. Ketamine is a noncompetitive, high-affinity     antagonist of the N-methyl-D-aspartate type glutamate receptor, with additional effects on     dopamine and μ-opioid receptors. During the last 9 years several uncontrolled reports have     been published, showing a rapid and impressive effect of ketamine in TRD patients (Berman,     Cappiello et al. 2000; Zarate, Singh et al. 2006; Mathew, Murrough et al. 2010; Aan Het Rot,     Zarate et al. 2012; Mathew, Shah et al. 2012; Murrough, Iosifescu et al. 2013). Recently     three placebo-controlled trials showed that a single dose of sub-anesthetic, (0.5 mg/kg) slow     intravenous (IV) ketamine improves depressive symptoms dramatically. Across studies, a     clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25     patients. Nonetheless, all but two patients relapsed <2 weeks post-ketamine (Zarate, Singh et     al. 2006; aan Het Rot, Zarate et al. 2012). Rot et al. showed that repeated IV ketamine     infusions prolongs the duration of improvement.      The investigators believe that the data presented above allows us to provide ketamine     treatment here in the Sheba Medical Center for TRD patients.   "
84364|NCT02181764|"     The objective of this study is to assess the safety and tolerability of KRN23 after a single     subcutaneous (SC) administration in subjects with X-linked hypophosphatemic     rickets/osteomalacia (XLH) in Japan or Korea.   "
81449|NCT02219854|"     Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric     cancer is popular in East Asian countries. However, the long-term follow-up outcome based on     randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic     distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe     procedure by experienced surgeons in high-volume specialized hospitals. However, the     application of it is still limited because of lack of solid evidence on the oncologic     efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is     estimated up to 80 percent of all gastric cancer cases in China. Before the clinical     application of laparoscopic procedure for the treatment with curative intent to advanced     gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy     must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and     open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer     based on a well designed RCT is needed.   "
81450|NCT02219841|"     This prospective randomized pilot study aims to evaluate the impact of aggressive life style     modification in terms of calorie-controlled diet and supervised exercise on outcome of     catheter ablation in overweight and obese patients with atrial fibrillation.      Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen     improves the chances of freedom from recurrence following catheter ablation.   "
81451|NCT02219828|"     Recent findings suggest that recurrent pericarditis (RP) may be a previously unrecognized     autoinflammatory disease. The pivotal pathogenic role of interleukin (IL)-1 in RP has been     shown by the achievement of complete responses after treatment with the recombinant     IL-1-receptor antagonist, anakinra. Anakinra is the recombinant form of IL-1Ra. The proposed     study is designed to demonstarate the efficacy of anakinra in RP.   "
81462|NCT02219685|"     The primary objectives of this study are to evaluate the effect of sustained virologic     response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS)     and on neurocognition as measured by neurocognitive tests. This study will also evaluate the     antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose     combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.      During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF     FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit,     participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12     weeks.   "
81452|NCT02219815|"     The PREHAB study is a clinical trial where frail patients waiting for heart surgery are     randomly chosen to either receive the current standard of care or to participate in an 8-week     exercise/education program at a community-based cardiac rehabilitation facility. Patients can     wait for elective heart surgery for as long as 3-4 months. During this time, individuals are     often fearful of making things worse, causing them to stop being active and further     deteriorate their physical condition. This wait period presents a potential opportunity for     health care providers to engage the patient to take control of their self-managed care prior     to surgery with the intent of improving post-surgical outcomes. Patients randomized to the     PREHAB intervention group will participate in supervised exercise twice per week in a program     designed to improve physical functioning and exercise capacity. The investigators hypothesize     that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will     reduce frailty, improve exercise capacity, improve physical activity behaviour, improve     in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and     improve overall quality of life.   "
81453|NCT02219802|"     Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and     drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in     primary percutaneous coronary intervention (PPCI). However, this did not result in a     reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of     the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility     of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term     clinical results, with sustained safety and efficacy at 12 months follow-up. To date little     is known about the long-term effects of this treatment modality in STEMI. Besides,     angiographic follow-up is of great clinical importance by giving insight on the treated     infarct lesion and to assess the functional angioplasty result.      Objective: This randomized controlled, non-inferiority trial is mainly designed to     prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only     strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction     (STEMI).   "
81454|NCT02219789|"     This phase I trial studies the side effects and best dose of alisertib when given together     with fulvestrant in treating patients with hormone positive breast cancer that has spread to     other parts of the body or has spread from where it started to nearby tissue or lymph nodes     and cannot be removed by surgery. Alisertib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Estrogen and progesterone are type of hormones     made by the body and they can cause the growth of breast cancer cells. Hormone therapy using     fulvestrant may fight breast cancer by lowering the amount of estrogen or progesterone the     body makes. Giving alisertib together with fulvestrant may be a better treatment for breast     cancer.   "
81455|NCT02219776|"     Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery     propionibacterium acne remains a leading cause of post-operative infections. The purpose of     this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to     chlorhexidine-impregnated skin preparation in attempting to lower the colonization     propionibacterium acne prior to surgery. This study will take cultures from patients who are     randomly assigned into groups that receive and do not receive benzoyl peroxide as additional     skin prep prior to elective shoulder surgery and compare quantified culture results.   "
81456|NCT02219763|"     Evaluate the impact of a 12-week behavioral weight management program on body weight and     quality of life. We hypothesize that participants will lose body weight and see improved     quality of life after program completion.   "
81457|NCT02219750|"     Comparison of efficacy and safety of different insulin regimens between basal bolus and     premixed insulin in poorly controlled type 2 diabetes   "
81458|NCT02219737|"     This phase I trial studies the side effects and best dose of ibrutinib when given together     with rituximab, ifosfamide, carboplatin, and etoposide (combination chemotherapy) in treating     patients with diffuse large B-cell lymphoma (DLBCL) that has returned after a period of     improvement (relapsed) or has not responded to treatment (refractory). Ibrutinib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as, rituximab, ifosfamide, carboplatin, and etoposide, work in different     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving ibrutinib together with combination     chemotherapy may be a better treatment for patients with relapsed or refractory DLBCL.   "
81459|NCT02219724|"     This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to     evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered     intravenously in participants with locally advanced or metastatic solid tumors that have     progressed after all available standard therapy or for which standard therapy has proven to     be ineffective or intolerable, or is considered inappropriate. This study will consist of a     screening period, an initial treatment period, a re-treatment period (for participants who     discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment     follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an     expansion stage. The planned duration of the study is approximately 3 years.   "
81460|NCT02219711|"     MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit     a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR,     DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with     advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism,     pharmacodynamic and clinical activity profiles.      During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the     Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient     populations.      Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor     type, including but not limited to, non small cell lung cancer and head and neck cancer     positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR     gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3     gene loci, or having loss of function mutations in the CBL gene. In addition patients with     clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate     cancer with bone metastasis will be enrolled.   "
81461|NCT02219698|"     The purpose of this study is to determine the safety and efficacy of symptomatic treatment     (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.   "
81465|NCT02219646|"     Given the protective effect of nitric oxide (NO) on the endothelium and the results obtained     so far in short-term, continuous treatment with phosphodiesterase-5 (PDE5) inhibitors on     parameters of endothelial function, we hypothesise that chronic treatment with vardenafil can     prevent or delay the deterioration of systemic endothelial function in patients with type 2     diabetes mellitus. The favourable effect of PDE5 inhibitors on sexual function in these     patients has been convincingly demonstrated in the past. Here we hypothesise that vardenafil     treatment can have beneficial effects on the vascular physiology in other body districts,     possibly preventing the development of microangiopathy and atherosclerotic cardiovascular     disease in these patients.      The main goal of this study is therefore to monitor the endothelial dysfunction during     continuous treatment with vardenafil for 6 months; object of the study will be endothelin 1     and other known parameters of endothelial damage in newly diagnosed patients with type 2     diabetes mellitus.   "
81466|NCT02219633|"     The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652     cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.   "
81467|NCT02219620|"     To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and     cognitive functioning in residents living in a community-based adult long-term care facility.      Hypothesis 1: Residents who participate in the MiM group will improve in emotional     functioning, as compared to residents in the control group.      Hypothesis 2: Residents who participate in the MiM group will improve in cognitive     functioning, as compared to residents in the control group.   "
81468|NCT02219607|"     The use of epidural anesthesia and postoperative analgesia influences fluid balance following     colorectal surgery.      Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate     intravascular fluid load and predict outcome after colorectal surgery.   "
81469|NCT02219594|"     In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug     eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though     it was about 3-5% in general. It is particularly important that in-stent restenosis after     implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate     for narrow area calculation, more clear for narrow organization structure and more specific     for detecting tissue types.It is currently the best way for restenosis histologic     diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive     instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as     the gold standard of stent restenosis.      The improvement of spatial resolution of Gemstone CT can effectively improve the imaging     quality and the measurement's accuracy of coronary artery stents.The diagnostic value of     in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a     certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.      This study will examine the degree of in-stent restenosis by the gemstone CT and the     320-detector row spiral CT and compare the two ways on the basis of the result of OCT.   "
81470|NCT02219581|"     The purpose of this study is to evaluate if the use of two small doses of intravenous (IV)     steroids around the time of knee replacement surgery decrease a patient's pain or use of pain     medication. The investigators will also determine if the subjects receiving the steroid will     have better pain control and better postoperative outcomes after their surgery.   "
81472|NCT02219555|"     We hypothesize that the ultrasound detectable variations in nerve, tendon and SSCT mobility     in patients with CTS may be useful clinically, not to diagnose CTS, but instead as functional     biomarkers that correlate with, and thereby serve as predictors for, treatment response. To     test this hypothesis, we propose a longitudinal clinical study in which patients presenting     for treatment of CTS will be monitored by ultrasound and by clinical assessment before and     after non-surgical and surgical treatment. We will correlate the clinical outcomes with the     initial ultrasound motion patterns that we have found to be most variable in CTS patients. We     will also test the hypothesis that successful treatment results in a change towards normal in     the affected ultrasound variables.   "
81473|NCT02219542|"     The investigators designed a study to determine whether with combined general-transversus     abdominis plane block anesthesia or standard general anaesthetic would provide same level of     cytokines in patients undergoing Laparoscopic Colonic Surgery.   "
81474|NCT02219529|"     A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's     approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy     of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging     results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse     and focal diseases in stomach, we performed this single-blinded multi-center prospective     study compared MCE with gastroscopy in patients with gastric symptoms and indication for     upper GI Endoscopy.   "
81475|NCT02219516|"     This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD)     study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.   "
81476|NCT02219503|"     The purpose of this study was to evaluate the safety and efficacy of ombitasvir/     paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus     (HCV) infection and cirrhosis.   "
81477|NCT02219490|"     The purpose of this study is to evaluate Long-term outcomes following treatment with     ABT-450/r/ABT-267 and ABT-333 with or without RBV in adults with genotype 1 Chronic Hepatitis     C Virus (HCV) infection.   "
81478|NCT02219477|"     The primary objectives of this study are to assess the safety and the SVR12 rate of     ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with     decompensated cirrhosis.   "
81479|NCT02219464|"     The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal     oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under     moderate sedation.   "
81480|NCT02219451|"     The purpose of this study is to verify the effects of exercise training on sympathetic     modulation and arterial baroreflex control in patients with chronic heart failure.   "
81649|NCT02217241|"     The purpose of this study is to assess the effectiveness of an educational intervention on     handoffs implemented during the third year of medical school. It also assesses whether these     skills are maintained over time into their fourth year of training and whether there is     transfer from the simulated setting into the clinical environment.   "
81481|NCT02219438|"     Patients usually experience moderate-to-severe pain following the knee replacement that is     often treated with a femoral nerve block (injection of numbing medicine placed around the     main nerve of the knee joint). To make the nerve block last longer, a tiny tube is often     placed next to the nerve and numbing medicine is infused for multiple days. However, while     the numbing medicine takes away pain, it also decreases sensations, muscle strength, and     proprioception (knowing where the leg is in space without looking at it) which greatly     increases the risk of falling. Since falling can be catastrophic following major surgery, a     femoral nerve blocks are being phased out by surgeons and anesthesiologists. The     most-promising replacement is called an adductor canal nerve block. For this new type of     block, a perineural catheter is inserted into a small canal in the middle of the upper leg.     This canal contains the sensory nerve fibers leading to the knee, and only a single nerve     that serves a relatively small muscle. Multiple studies have demonstrated a dramatic increase     in muscle strength using the new adductor canal block compared with the traditional femoral     block. However, practitioners perceptions of the new block is that it provides insufficient     pain control following knee arthroplasty, even though all of the sensory nerves affected with     the femoral block are also—theoretically—affected with the adductor canal block. One reason     for this difference may be the small canal of the latter which is a relatively tight area in     which the numbing medicine might not spread particularly well (due to pressure from     surrounding tissues). One way to possibly counter this issue is by providing repeated boluses     of the numbing medicine that will improve the medicine's spread relative to a     more-traditional slow, continuous (basal) infusion. This study seeks to compare these two     techniques of medication administration through perineural adductor canal catheters:      Our primary aim is to test the hypothesis that, for continuous adductor canal blocks,     providing local anesthetic as repeated, hourly bolus doses results in an increased sensory     block compared with providing local anesthetic as a continuous basal infusion at an     equivalent hourly dose.      As a secondary aim, we hypothesize that, for continuous adductor canal blocks, providing     local anesthetic as repeated, hourly bolus doses results in either equivalent or less motor     block compared with providing local anesthetic as a continuous basal infusion at an     equivalent hourly dose.   "
81482|NCT02219425|"     The aim of this study is to evaluate the gene expression of the endometrium after an     endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.   "
81483|NCT02219412|"     This study was a feasibility trial that was designed to provide preliminary observations and     generate hypotheses for future studies. The aim of the study is to estimate the difference of     arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and     aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary     artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet     aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of     aspirin/ticagrelor dual-therapy.   "
81484|NCT02219399|"     Supplementation with DHA during pregnancy will increase gestational length and improve     cognitive development.   "
81485|NCT02219386|"     Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the     dimminution of pain of patients   "
81493|NCT02219282|"     As a result of rises in living standards quality of life is progressively increasing.     Combined with developments in anesthesia, surgical techniques and medication allowing more     difficult and complicated interventions to be carried out, elderly patients are encountered     more often in daily anesthetic practice.Reduced tone in the upper airway of geriatric     patients increases the possibility of airway obstruction. In old patients with no teeth,     sunken cheeks may make ventilation with a mask ineffective; perhaps even impossible.      In addition to our observations that Laryngeal mask (LM) is more difficult to place in older     patients, in the literature there are very few studies on the use of LM in older patients.     Sixty percent of patients over the age of 65 have no teeth. Ventilation with a mask is more     difficult for patients without teeth compared to those with teeth. Laryngeal mask is an     alternative airway device for patients without teeth when the face mask does not sit     correctly.      The aim of this study is primarily to measure the success of placement on first try, ease and     duration of insertion and oropharyngeal leak pressure of laryngeal mask Unique (LMU) in     patients 65 years of age and above dentulous and edentulous elderly patients. The secondary     aim is to compare the effects on the hemodynamic response occurring during placement.   "
87561|NCT02139943|"     The purpose of this study is to assess the effects of administration of canagliflozin 100 mg     and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type     1 Diabetes Mellitus (T1DM).   "
81486|NCT02219373|"     Given the widespread use of anticonvulsants in the pediatric chronic pain population and the     absence of scientific data supporting their use, the investigators propose a randomized,     double blind, two group parallel design in which a broad group of children and adolescents     with chronic neuropathic pain would be randomized to receive either Gabapentin or     Oxcarbazepine.      The Primary Aim of the Study is to assess the frequencies of successful treatment of     pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine.      The Primary Hypotheses are as follows:      Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in pain     scores when compared to each patient's baseline.      Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during the     second phase of the trial will report greater pain reduction relative to baseline than     patients who are randomized onto placebo at this randomization point.      Secondary Aims of the Study are to compare groups treated initially with Gabapentin or     Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked     maneuvers), functional disability scores, tolerability, and measures of mood and cognitive     functioning.      Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on:        1. Pain scores at rest and with evoked maneuvers        2. Functional disability scores        3. Tolerability (frequencies of side-effects)        4. Depression and anxiety scales        5. Neuropsychological measures of cognitive processing speed, working memory, and          attention.   "
81487|NCT02219360|"     Chronic obstructive pulmonary disease has become a serious global health care and public     health problems due to its high prevalence, high morbidity and heavy economic burden. Acute     exacerbation of chronic obstructive pulmonary disease is one of the most important causes of     death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD     exacerbations. In clinical practice for the treatment of acute exacerbation of COPD，     antibiotic application is still controversial. Evidence from current guideline is based on     strict criteria from randomized controlled trials, thus the given condition is simplified.     Patients meet the criteria account for the minority in the real world. Therefore, it is still     not clear whether most patients benefit from the recommended treatment. In our design,     hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment,     arterial hypoxemia, recovery time and length of hospitalization being observed. The main     purpose is to evaluate the benefit effect of current recommended treatment of acute     exacerbation of COPD in the real world.   "
81650|NCT02217228|"     Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia     microparticles with or without laser in the treatment of moderate to moderately-severe     inflammatory acne vulgaris   "
81488|NCT02219347|"     Rheumatoid arthritis is a common condition affecting approximately 1% of the United Kingdom     population; it is an autoimmune disease where the body's natural defences (the immune system)     attack the body itself resulting, most notably, in joint damage and arthritis. To help     prevent this, patients with rheumatoid arthritis need to take disease-modifying     anti-rheumatic drugs (DMARDs). As rheumatoid arthritis is a life-long condition, these drug     treatments are prescribed as long-term medications taken for many years.      With successful drug treatment, many patients are able to achieve an excellent control of     their disease and their arthritis can go in to remission. At present, there are no markers     which can reliably predict which of these patients can reduce their drug treatment, and hence     benefit from a lower risk of side effects and inconvenience, without an increase in their     arthritis activity.      We invite patients with stable rheumatoid arthritis to participate in this study conducted by     Newcastle upon Tyne Hospitals NHS Foundation Trust in collaboration with Newcastle University     and funded by the Wellcome Trust. Patients whose arthritis is confirmed as being in remission     will be able to stop their DMARD medication and be monitored for a period of 6 months.     Patients whose arthritis activity increases during this time will be able to restart their     DMARD medication, whereas those patients whose arthritis remains in remission will be able to     stay off DMARD medication.      The main aim of this study is to identify clinical, ultrasound and blood markers that can     predict which patients will remain in remission after stopping DMARD medication. If     identified, these markers could be a useful guide to doctors and patients in the future when     deciding whether to stop DMARD therapy.   "
81489|NCT02219334|"     The purpose of our study is to determine the safety, efficacy, length of stay and parental     satisfaction of the NoseFrida in comparison to a suction device used in the hospital setting     in patients with bronchiolitis admitted under observation status.   "
81490|NCT02219321|"     Prescription drug abuse represents a major healthcare problem, with treatment costs reaching     billions of dollars annually in the United States alone. Today opioids are commonly     prescribed for chronic non-cancer pain and are only partially effective for short-term pain     relief. Whereas opioids are initially part of the solution for pain, it eventually often     turns to be a problem in patient with chronic pain. Long-term treatment with opioids can be     complicated by development of tolerance, dependency, addiction, abnormal pain sensitivity,     hormonal changes, and immune modulation. Unfortunately, the chronic use of anti-inflammatory     drugs is associated with a marked increase in adverse effects.      The purpose of this study is to determine whether systemic administration of lidocaine     provides effective pain relief in opioid dependent chronic pain patients. Investigators     intend to demonstrate that lidocaine infusion can improve pain relief and physical function     in opioid dependent patients, thus improving compliance and patient satisfaction, which may     potentially help wean patients off narcotics. The long-term goal of this proposal is to     decrease opioid dependence in chronic pain patients by using lidocaine infusion.   "
81491|NCT02219308|"     Intrauterine device (IUD) placement can be painful for patients during and after the     procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly     effective long acting reversible contraception. Currently there are no proven effective     methods for reduction of pain during and after placement of modern IUDs. Paracervical block     pain may decrease this placement pain.   "
81492|NCT02219295|"     We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism.     There ist growing evidence, that components of the taste signalling system, including the     taste receptor proteins , have important functions in the regulation of metabolic parameters     in non-gustatory tissues.   "
81510|NCT02219061|"     Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.        -  Geometric mean titers(GMTs) of measles and meningitis C.        -  Follow-up on 0 month, 3rd month,5th month and 7th month after birth.   "
81511|NCT02219048|"     The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe     asthma when added to standard of care and during staged withdrawal of background therapy.   "
81494|NCT02219269|"     The investigators will conduct a prospective observational cohort study to investigate     factors that influence contraceptive method utilization among women with medical conditions.     The investigators will also investigate how women with medical conditions access to     contraception and family planning fellowship trained specialist. After the baseline     questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate     continuation and satisfaction with the contraceptive method. This study is unique because it     will allow us to explore doing collaborative family planning research at the multiple UC     medical campuses.   "
81495|NCT02219256|"     The purpose of this study is to characterize the pharmacokinetic and safety and tolerability     profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC)     administration at escalating dose levels in healthy participants.   "
81496|NCT02219243|"     A substantial number of children with social anxiety fail to gain benefit from contemporary     cognitive-behavior therapy (CBT) approaches. More novel treatment approaches for treatment of     social anxiety are needed. The current study attempts to modify an interpretation style that     is characteristic of children who also display high anxiety in social situations.     Participants between the ages of 8-12 years old, with social anxiety, will be randomly     assigned to one of three treatment conditions: two conditions are designed to manipulate the     interpretation bias or a wait-list control condition. All study procedures will be conducted     online. This study will help develop an effective cognitive intervention program for social     anxiety in children.   "
81497|NCT02219230|"     The goals of this study are to assess measured, observed, and self-reported outcomes achieved     through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological)     prosthetic knee control systems in individuals with unilateral, transfemoral amputation.   "
81515|NCT02218996|"     The purpose of this study is to examine the content of the treatment being delivered for     anxiety disorders for children and adolescents in the regular outpatient clinics in western     Norway. The study will also collect data before and after treatment to evaluate the result of     the treatment. Furthermore, as part of the study we aim to collect normative data on two     questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere     with daily functioning. We also aim to develop a quality indicator for anxiety treatment that     can be used to monitor treatment in the regular outpatient service, based on the results of     the current study.   "
81498|NCT02219217|"     The purpose of the study is to look at the levels of three HIV medications: dolutegravir,     elvitegravir and cobicistat in blood after the drug intake has been stopped in order to     understand how long these drugs persist in the blood. The study will specifically look at     blood levels of these three drugs after taking them every day for 10 days dolutegravir on a     first stage and a combination of elitegravir and cobicistat in a second stage.      If the participant decides to take part, the duration of the study will be up to 38 days plus     a screening visit which will take place up to 28 days prior to the start of the study, and a     follow up visit which takes place 7 to 14 days after the last dose of study medication.      This study is not randomised which means that all participants will receive all study     medications in the same order. The participant and the study doctor will know which study     medications the participant is taking at all times during the study.   "
81499|NCT02219204|"     Dry eye is a major, common medical condition with significant health and economic burden in     Singapore and worldwide. It is a holistic problem affected by living habits, nutrition and     underlying systemic disease, inducing a significant decrease in quality-of-life. The hallmark     of this disease is raised tear osmolarity and inflammation. There is no definitive cure for     this condition, as treatment in the form of lubricants is only symptomatic and treatment with     cyclosporine eyedrops is expensive and may not be well tolerated.      Following the rise in international interest in complementary medicine, randomized-controlled     studies in dry eye using Traditional Chinese Medicine (TCM) have been published, with mixed     results. However, the major limitation of these studies is the lack of objective assessment     for inflammation.      We propose to collaborate with an academically-trained Singapore TCM physician who has     conducted dry eye trials, and synergistically exploit the existing state-of-the-art dry eye     monitoring technologies available at Singapore Eye Research Institute (SERI). This proposal     is cost-effective, building on previous government grants and expertise to provide definitive     scientific evidence on the efficacy and safety of TCM in dry eye. SERI has an international     reputation for interventional studies, and the PI has a good academic relationship with the     above TCM physician. We propose to screen, recruit and treat 150 patients with a herbal     preparation and acupuncture, and evaluate over 4 weeks in a randomized-controlled study.     Tests to be performed will include tear imaging and osmolarity, as well as protein and     cytokine assays.      Singapore is uniquely positioned at the crossroads of the East and the West to take the lead     in this field. Given that there is an increasing patient interest in holistic care in     Singapore and the rise of scientifically trained TCM practitioners, a study like this one is     very timely, and will have tremendous impact to healthcare delivery in Singapore.   "
81500|NCT02219191|"     To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in     patients with chronic rheumatic diseases   "
81501|NCT02219178|"     This study aims to evaluate the overall response rate after 4 cycles and the best response to     induction therapy with combination of lenalidomide, subcutaneous bortezomib, and     dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.   "
81502|NCT02219165|"     Staphylococcus aureus and Streptococcus pyogenes produce many virulence factors. Some of them     are responsible for severe infections in humans. Superantigen toxins synthesized by S. aureus     or by S. pyogenes, are responsible for toxic shock syndromes (TSS) which lethality can attain     25% in children with validated criteria of septic shock.      Previous studies, performed in vitro and in vivo in animals, have shown that Intravenous     immunoglobulins [IVIG] contain antibodies [Ab] against these toxins and, when used at high     concentration, IVIG are able to neutralize their toxicity. However, in all these studies,     IVIG administration has been preventive and there is no reliable data demonstrating their     therapeutic efficacy in vitro or in vivo in humans or in animals, once the disease is     present.      The efficacy of IVIG is established in other pathologies for which the role of the     superantigens [superAg] is suspected, like Kawasaki disease in children. The mechanism of     action, although not perfectly known, involves at the same time a direct effect on superAg     (Ag-Ab complex) and indirect effects like the neutralisation of superAg within the network of     anti-idiotype Ab or the neutralisation of the T-cells receptors. Staphylococcal and     streptococcal toxic shocks imply bacterial exotoxins that are superAg. It seems thus     consistent to imagine a same type of treatment with IVIG. However, there is currently no     evidence of the efficacy of IVIG in this indication. One of the explanations relies on the     lack of statistical power of previous adult studies, which principal objective was to show a     reduction of the mortality. Taking into account the low prevalence of TSS, it has been hard     to recruit enough patients to have the required statistical power. Moreover, some works have     been extracted from larger studies on septic shock and the definitions of the TSS were nor     always very reliable. Lastly, if the investigators consider the definition of the TSS as     mentioned by the  Centre for Disease Control  [CDC], for which any hypotension, even a     simple orthostatic hypotension, serves the diagnosis of TSS as long as the other symptoms are     present, it is obvious that many patients are likely to be recruited in a study although it     is highly probable that their health will get better with a  standard  treatment. The     definition of a  real  TSS can be refined, keeping the CDC criteria, but changing the     hypotension criterion in a more accurate criterion as described in the  surviving sepsis     campaign , internationally accepted and based on norms adapted to the age for paediatric     forms.      IVIG therapy is very expensive and TSS is not recognized as indication of IVIG according to     their marketing authorization. The feasibility of a randomized controlled study with this     treatment needs to be assessed as it would be hazardous to conduct a large prospective RCT     without having first assessed this feasibility in terms of recruitment rates, consent rates     or compliance rates. Inclusion, randomisation and collect of inform consent in the context of     severe shock are challenging and require evaluation of feasibility. The sample size     calculation of the large study on mortality required estimations of the event in the specific     population of children with criteria of septic shock. Surrogates markers of outcome need to     be better defined. For example it would be useful to determine the evolution of organ     dysfunctions with and without IVIG treatment in this population.      Various organ failure scores, used upon admission and later on, have been validated in adults     and in children. The absence of improvement of the Paediatric logistic organ dysfunction     (Pelod) score over time is a good indicator of mortality in Paediatric intensive care unit     (PICU). It could be used as surrogate marker to evaluate the efficacy of IVIG.   "
81503|NCT02219152|"     Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.      Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial     amount of bleeding that requires a special treatment or follow up.      The goal of this study is to examine whether submission of tranexamic acid during the biopsy     could diminish the amount of bleeding.   "
81504|NCT02219139|"     Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions     on modified surface abutments compared to machined surface abutments.   "
81505|NCT02219126|"     This study aims to investigate differences in digestion rates and stomach problems caused by     pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible     capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol     levels and plasma cytokine levels.   "
81506|NCT02219113|"     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front     abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm     study with no control. All patients receive cell therapy.   "
81507|NCT02219100|"     This study examined the acceptability and feasibility of using a simplified regimen of     medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone     and misoprostol, and buccal administration of misoprostol, would be both acceptable to women     and efficacious.   "
81508|NCT02219087|"     The purpose of this study is to determine whether liposomal bupivacaine is effective in the     management of pain following total knee arthroplasty, as compared to standard of care     analgesia.   "
81509|NCT02219074|"     Prospective, multicenter study with multiple arms to examine the safety and effectiveness of     the Sebacia Acne Treatment System for the treatment of acne vulgaris.   "
88803|NCT02123693|"     The aim of the present study is to determine whether there is a relationship between     osteopathic treatment and the change of physiological axes of the lumbar spine, through the     use of Dynamic Magnetic Resonance Imaging.   "
81512|NCT02219035|"     In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand     factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13     levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global     haemostasis will be assessed using thrombin generation and the relation between increase     thrombin generation and VWF explored. Thrombin generation will be performed pre and post     filtration for the presence of procoagulant microparticles. These parameters will be     investigated acutely, at presentation and in convalescence; in addition, the effect on these     parameters of treatment such as thrombolysis may be informative. Correlation between measured     parameters and adverse clinical outcome would be used to identify markers of severity and     progression of ischaemic stroke and identification of potential novel approaches to therapy     that might improve outcome.   "
81513|NCT02219022|"     A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients     will be randomized into two groups. Experimental group will do a 12 weeks training of     progressive resistance exercise for global muscles and remain with the clinical treatment and     the control only remain with the clinical treatment. Patients will be evaluated at baseline,     after 6, 12 and 24 weeks.   "
81514|NCT02219009|"     The purpose of this study is to determine the usability of the Medical Information Device #1     (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.   "
81556|NCT02218463|"     First-line treatment for labial adhesions in prepubertal girls has been topical estrogen.     This study aims to evaluate an alternative and less costly option of treatment with     potentially less side effects.      Primary Hypothesis:      There will be a difference in complete resolution of labial adhesions with topical estrogen     with lateral traction as compared to an emollient with lateral traction.   "
81516|NCT02218983|"     Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in     critical care. First introduced for volume assessment in nephrology and cardiology, it is now     being researched in emergency and critical care. Data is still evolving in its use in initial     trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in trauma, but     utility of its measurement on U/S in the emergency department still has some controversy. In     trauma specifically, small studies suggests benefit to the use of U/S to predict volume     status, and most of these data are from one author. It is not known if this can be applied     more broadly. The prognostic value of findings on limited transthoracic echocardiogram (LTTE,     SonoSite Ultrasound) has been studied in several small studies, and only one small randomized     controlled trial has proven benefit to its use. Due to inter-rater reliability and the fact     that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one     group, it is not known if it can be applied to all trauma populations.      Research question:      Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit     (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as     well as or better than other methods of organ perfusion?      Hypotheses:        1. Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital          and ICU stays, transfusions, and mortality).        2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on ventilator,          number of and transfusions better than other methods of organ perfusion (tachycardia,          hypotension, lactate, lactate clearance, creatinine, base deficit).   "
81517|NCT02218970|"     Physical health does not have a high priority in today's treatment of patients with substance     use disorder (SUD). SUD patients have a poor physical health not only due to injuries related     to the substance abuse, but also because of the addiction-related lifestyle. There are few     studies today that provide information about SUD patient's physical health, and especially     there is little information about their muscular strength. One of the project's aims is to     measure muscular strength in SUD patients who are being treated for their addiction, and see     if they have decreased neuromuscular function. If so, we will investigate the effect of     maximal strength training on neuromuscular function in these patients.   "
81518|NCT02218957|"     Morbid obesity is an increasing medical problem in the western countries. It's related to     comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.     The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese     patients. A part of these patients will have disappointing results, and have weight regain on     the long term. Some studies show more weight reduction by increasing the biliopancreatic limb     in patients with morbid obesity.      The objective of this study is to investigate the effect of a restrictive/extended pouch on     weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the     restrictive/extended pouch results in more weight reduction.      The study design is a prospective, randomized control trial. The patients will be randomized     in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.   "
81519|NCT02218944|"     The current study tests a response inhibition retraining program, implemented on a mobile     device, as a mechanism to increase relapse prevention during a smoking cessation attempt.     Study participants (n = 150) are randomly assigned to a control, benign, or intervention     condition. They complete 2 weeks of response inhibition retraining, and then engage in a     cessation attempt. It is hypothesized that individuals who receive the intervention will have     a decreased likelihood of relapse following the cessation attempt. In addition, it is     hypothesized that this is due to decreases in implicit smoking motivation as a function of     the response inhibition training.   "
81528|NCT02218827|"     Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms.     epidemiologic studies estimate that as many as 15% of the population over 60 years suffer     from dry eye. the disease can be treated both topically through several drugs or through     mechanical closure of the lacrimal drainage system. in the past decade a few studies     demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the     inflammatory process that occurs in it. this treatment rises goblet cell counts but in the     meantime elevates the intra ocular pressure and elevates the risk for infections. steroids     that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry     eye disease. we with to subjectively and objectively evaluate an FDA approved topical     steroidal drug in the treatment of dry eye.   "
81520|NCT02218931|"     Obesity is a growing problem in East London and every other woman who enters pregnancy is     obese or overweight. In addition to obesity, other metabolic risk factors such as raised     lipids, high blood pressure and diabetes increase pregnancy related complications such as     preeclampsia and long term problems such as heart diseases, stroke and death. Preeclampsia,     presenting as hypertension and proteinuria is a leading cause of maternal and fetal mortality     and morbidity. Interventions that reduce cardiovascular events by modifying risk factors also     have the potential to reduce the risk of preeclampsia. The investigators work funded by the     National Institute of Health Research (NIHR) in the UK showed that dietary interventions in     obese pregnant women may reduce the risk of preeclampsia. The investigators propose to show     that pregnant women with metabolic risk factors derive the most benefit from a simple,     targeted intervention based on Mediterranean dietary pattern to reduce the risk of maternal     and fetal complications . Women with the risk factors (1230 women) will be randomly allocated     to dietary intervention or usual antenatal dietary advice and the risk of maternal and fetal     complications will be evaluated. The remaining eligible women who are consented for lipid     tests, but do not have metabolic risk factors, will be followed up for outcome data only.     Diet based interventions, especially those based on a Mediterranean dietary pattern has a     potential to reduce the risk of preeclampsia. In the investigators study, pregnant mothers     with risk factors will be randomly allocated to either a dietary invention or usual antenatal     care and they will assess their composite maternal (pre-eclampsia or gestational diabetes)     and fetal (stillbirth, small for gestational age or admission to neonatal intensive care     unit) outcomes. The investigators will tailor the intervention to suit the individual needs     of the mother and provide nuts and olive oil to improve compliance. The study will be     undertaken across the three maternity units at Barts Health NHS Trust, which delivers 17,000     women/year and two other maternity units in England. The study is supported by the office of     the Mayor of Tower Hamlets which will facilitate the involvement of grassroots workers to     promote recruitment and uptake of the intervention.   "
81521|NCT02218918|"     Pulmonary Rehabilitation became a vital part of management in COPD patients in form of     activity modification, dietary and pharmacological optimisation. But access to traditional     supervised aerobic (treadmill) walking is debatable fact due to economical and staffing     expertise in developing countries like India. The investigators designed a randomised     controlled trial to evaluate the effectiveness of ground based walking over traditional     treadmill walking in improving quality of life in COPD patients.   "
81522|NCT02218905|"     This study is to find relation between number of repetitions the volunteer able to sit and     stand in an armless chair and their age, height, weight and gender. The investigators     hypothesis there is a moderate relation between anthropometric characteristics and number of     situps. This may partially define the ability of functional capacity and quadriceps ability.   "
81523|NCT02218892|"     Purpose and aims The general aim of this project is to improve the diagnostic methods for     disease activity and identify predictive factors (clinical and radiographic factors, pro- and     anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ)     involvement in juvenile idiopathic arthritis (JIA).      The hypothesis is that self-reported pain and impaired jaw function together with clinical     findings correlates well with radiological signs of jaw involvement.      Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not     correlate with radiological signs of jaw involvement.      Study 1 The aim of this study is to investigate which findings from the patient history and     from clinical examination that is of significance for diagnostics of TMJ involvement in     patients with JIA both in a short- and long-term perspective. The patients will be     followed-up during two years. They will undergo a clinical examination according to Research     Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once     a year and a telephone follow-up sixth months after the clinical examination. Further, the     clinical findings from the orofacial regions will be compared to their general disease     activity.      Study 2 The aim of the second study is to correlate radiological findings and clinical     findings in order to investigate any early radiological signs of disease activity and     progression but also to compare the radiographic examination using conventional panoramic     technique with computer tomography (CT).   "
81524|NCT02218879|"     The primary objective is to directly estimate brain glutathione concentrations in vivo using     H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS)     patients considering switching therapy or being treatment-naive (first line).   "
81525|NCT02218866|"     The goal of this research is understand if obesity is a major factor for neuropathy     development in patients with and without Type 2 diabetes. This study will examine the     relationship between weight, metabolism, and nerve function and regeneration.   "
81526|NCT02218853|"     The objective of this multi-site research collaboration is to test the manifestation and     distribution of biological markers for psychosis and affect dimensions across the     schizophrenia/bipolar (SZ-BD) diagnostic boundary, and to examine heritability and genetic     associations for these biological markers.   "
81527|NCT02218840|"     Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This     study will be evaluating the behaviors of cigar smokers and the short term effects of cigar     smoking.      A cigar is defined as a cylinder of tobacco wrapped in a tobacco leaf for smoking. There are     small cigars with filters that resemble cigarettes and large cigars that do not have filters.     Because cigars come in so many shapes and sizes, the nicotine content varies as well. The way     that a cigar smoker consumes the cigar can also have an effect on how much nicotine is     absorbed. This study seeks to understand nicotine consumption and addiction in cigar smokers.      Study participation will last 1 to 4 weeks and will include 2 study-related visits. Your     visits may include a physical exam, medical history review, questionnaires, blood     collections, providing a urine sample, an exhaled breath test, having your vital signs     collected and smoking a cigar. You will be videotaped while you smoke your cigar so that we     can review the technique you use while smoking.      STUDY HYPOTHESES:        -  Significant reductions in craving and withdrawal will be reported after ad libitum          smoking of a cigar compared to self-report prior to cigar smoking.        -  Cigar smokers will show a range of nicotine dependence, with a subset of users exceeding          minimal criteria for nicotine dependence.        -  Levels of nicotine, cotinine, Carbon Monoxide (CO), and          4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) will increase significantly from          pre- to post-cigar smoking.        -  Small cigar/cigarillo users will demonstrate greater levels of dependence and greater          relief from craving and withdrawal compared to large cigar users.   "
81529|NCT02218814|"     The purpose of this study is to determine if patients undergoing a Total Knee Arthroplasty     who receive a single shot Adductor Canal nerve block and local infiltration will have     improved functional outcomes compared to individuals who receive a femoral nerve block and     local infiltration during the first 24 hours post surgery.   "
81753|NCT02215889|"     The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure     liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor     segments 2-3, the remaining liver segments of the recipient are removed. The patient will at     this time have only donor liver tissue in place.   "
81530|NCT02218801|"     This prospective database has two main objectives;        -  to evaluate the complication rates, 30-day and 90-day mortality from different surgical          strategies for unresectable, borderline resectable or initially unresectable liver          metastasis from colorectal cancer.        -  to establish baseline quality parameters for different surgical strategies for          unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM)          patients.   "
81531|NCT02218788|"     The purpose of this study is to assess the safety and performance of Hydroxytite in all     subjects who have received sub dermal or deep dermal injections.   "
81532|NCT02218775|"     The available treatments for patients with mood and anxiety spectrum disorders have     significant limitations. This study will contribute significantly to public health by taking     steps to address these limitations by aiding in the interpretation of a study that: 1) tests     a promising new treatment for mood and anxiety spectrum disorders; 2) evaluates a potential     target in the brain which could serve as the basis for development of additional new     candidate compounds for the treatment of patients with mood and anxiety spectrum disorders;     3) establishes more expeditious methods for evaluating potential new therapies for patients     with mood and anxiety spectrum disorders; and 4) specifically establishes methods for the     development of new therapies targeting anhedonia, an important RDoC (Research Domain     Criteria) endpoint.   "
81557|NCT02218437|"     Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow and     takes part in the bone marrow microenvironment. The response rate of early treatment on     Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG     treatment) is associated with long-term effect. The injection of Umbilical Cord Derived     Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.   "
81651|NCT02217215|"     The purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy     can improve the ability to detect the presence of premalignant lesions on the cervix.   "
81533|NCT02218762|"     The Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg)     twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and     licensed therapy for the treatment of asthma. GlaxoSmithKline (GSK) is developing the     ROTAHALER/ ROTACAPS® (Rdpi) inhaler as an alternative treatment option for asthmatic     patients. This study is a Phase I, randomised, double-blind, double-dummy, two- treatment,     four-way cross-over (replicate design), two sequence, repeat dose, two centre study in mild     to moderate asthmatics to compare the pharmacokinetics and pharmacodynamics of fluticasone     proprionate/salmeterol (100/50 mcg) delivered via the Rdpi versus the Ddpi. A total of 58     subjects will be enrolled to ensure 52 subjects complete all dosing occasions. Each subject     will be allocated to one of two treatment sequences and will participate in four treatment     periods, receiving each of the treatments twice.      DISKUS, ACCUHALER, ROTAHALER and ROTACAPS are registered trademarks of GSK groups of     companies.   "
81534|NCT02218749|"     The purpose of this study is to determine whether initial triaging to physiotherapists of     patients with musculoskeletal disorders who seek health care from primary care clinics     affects the patients health and/or health care utilization differently than initial     consultation with a general practitioner.   "
81535|NCT02218736|"     The available treatment for patients with mood and anxiety disorders have significant     limitations (Rush, 2007; Denys and de Geus, 2005). There is a need to develop new treatments     for people with these disorders. Many research studies carried out in animals and a few     preliminary studies carried out in humans suggest that medications which block kappa opioid     receptors (KOR) have potential for being effective new treatments for patients with mood and     anxiety spectrum disorders. These medications have shown particular promise for improving one     important type of difficulty experienced by many patients who suffer from mood and anxiety     spectrum disorders referred to as anhedonia, which is an impairment in reward-related     function. In this study we will test the hypothesis that KOR antagonism is a promising means     of improving anhedonia in patients with mood and anxiety spectrum disorders. We will do so by     evaluating whether we can establish Proof of Concept (POC) that a relatively selective KOR     antagonist, CERC-501 (formerly known as LY2456302), engages neural circuits involved in     mediating reward-related function in patients with mood and anxiety spectrum disorders with     anhedonia. We are attempting to establish POC in this study in order to determine whether     there is a sufficient basis for pursuing future work evaluating whether KOR antagonism has     therapeutic effects on clinical and behavioral measures of reward-related functioning.   "
81536|NCT02218723|"     This is an open-label, five- period, cross-over, randomized, single dose, single centre study     in healthy subjects. This is the second clinical study for the UD-DPI. This study will     ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the     plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of FF     delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the     ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three     dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This     study is designed to compare the pharmacokinetic profile of various doses and blends of FF     administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be     screened 28 days prior to study initiation. During each treatment period, subjects will be at     study site from evening prior to dosing until completion of the 48 hour post-dose PK sample     collection on Day 3. Minimum 7 days washout will be between treatments after completion of     all five treatments and the follow-up visit will be conducted 7-14 days post last dose.     Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of     companies.   "
81537|NCT02218710|"     The aim of the study is to assess bone geometry, bone compartment specific volumetric     densities and micro-architecture as well as to evaluate non-invasive estimates of bone     strength in patients with adult onset growth hormone deficiency.   "
81538|NCT02218697|"     The purpose of this study is to investigate the immunogenicity and safety when GSK     Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with     Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age     and older at risk for complications from influenza and pneumococcal infections.   "
81539|NCT02218684|"     The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg     telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.   "
81540|NCT02218671|"     Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE     941 OD tablets are administered in Japanese healthy male volunteers.   "
81541|NCT02218658|"     The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken     without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was     evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)   "
81542|NCT02218645|"     The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and     brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in     healthy adult male subjects.   "
81543|NCT02218632|"     Galactosaemia is an inherited condition caused by a lack of an enzyme (catalyst) which     normally breaks down galactose (the sugar found in milk products). This affects 1:19,000     births annually in Ireland (the highest incidence worldwide) and is screened for by the     National Newborn Screening Programme. When an affected infant is diagnosed, galactose is     immediately restricted from the diet. This prevents often fatal liver disease and other     immediate complications. However, despite early treatment the majority of affected patients     go on to develop long-term complications such as intellectual impairment, neurological     complications, speech difficulties and infertility in females. The underlying mechanisms for     these complications are unclear. The investigators have shown in detailed biochemical and     gene analysis studies that major abnormalities affecting the function of complex molecules in     the body, particularly glycoproteins, (consisting of sugar chains attached to proteins)     persist in treated individuals which may lead to disturbances of the body's intrinsic     cellular machinery and relate to the complications seen.      In this research the investigators expand on from their earlier studies to see if they can     identify biomarkers and parts of the galactose/glycosylation pathways which could be modified     or changed with new treatments to improve outcomes for this condition (i.e., IgG N glycans).      In more detail, the investigators test the use of the most abundant glycoprotein in human     plasma (IgG) as an improved clinical test for monitoring the galactose control needed in     patients and also to see if some patients (including children aged 5-12 yrs) might have a     better predicted outcome with moderate increases of galactose in the diet. The investigators     believe that these studies greatly improve the understanding of Galactosaemia with a view to     improving current treatment options and future outcomes.   "
81544|NCT02218619|"     Clinically, the ability to slow or prevent beta cell demise can prevent or improve the course     of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent major     pathological basis for the disease, has led to efforts to prevent or suppress this immune     assault. Here we propose to buttress the beta cell's capacity to withstand this assault by     improving the function of the endoplasmic reticulum stress resolving mechanisms within these     cells. The ability to do so could have a major impact on preventive and therapeutic     strategies for type 1 diabetes (and possibly other types of diabetes). The type of     endoplasmic reticulum stress relieving agent (TUDCA) proposed here could ultimately be     applied on an anticipatory basis to individuals at high risk for type 1 diabetes.   "
81545|NCT02218606|"     The purpose of this study is to see what effects (good and bad) treatment with abiraterone     acetate (an oral hormonal agent) and prednisone (a steroid) with and without cabazitaxel (a     chemotherapy) have on the cancer and to find out more about whether specific laboratory tests     on tumor are useful in predicting how the patient will respond to treatment.   "
81546|NCT02218593|"     This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for     children who are using the WREX, or have used it in the past. The survey consists of a set of     questions a) performed online and b) performed over the phone.   "
81547|NCT02218580|"     While there has been progress in juvenile idiopathic arthritis (JIA) management, there is no     cure. Despite receiving standard of care, many children live with pain. Thus, it is not     surprising that families turn to complementary and alternative medicines (CAM) therapies,     including massage therapy (MT). Little is known about the efficacy of MT in JIA.      In this project, a massage therapist will teach parents how to provide a massage to their     child with JIA at bedtime, at home. The feasibility of establishing a home MT program for     children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined.      This proposal is relevant to JIA families, who ask questions on MT to professionals of the     JIA clinic.      Beyond providing education to JIA families, this project demonstrates the team approach to     JIA management. Team members will include a pediatric rheumatology nurse and a massage     therapist.   "
81548|NCT02218567|"     The study hypothesis is that caregivers experience allows them to develop a lot of knowledge     and know-how about behavioural problems in Huntington Disease and its consequences. The     purpose of this study is to collect, describe and analyse caregivers experience in order to     find and enhance their knowledge related to the adaptation to behavioural problems of     Huntington Disease patients.   "
81549|NCT02218554|"     To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the     BRONJ Assay) in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for     developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV)     administration of Bisphosphonates (BP).   "
81550|NCT02218541|"     The study will involve placing a dental implant through a guided surgery protocol developed     using 3D CT technology. Because the implant position is planned digitally using the CT data     from the patient, this allows investigation of an abutment that supports the implant crown     and soft tissues to be fabricated prior to implant placement. In doing so, this makes the     protocol for patient care simpler and faster. In fabricating the the abutment prior to     surgery, the investigators will design the abutments at different heights below the gumline     to see an optimal margin height for fabrication of the abutment prior to surgery. The study     hypothesis is that more often the abutment margin placed just slightly below (.5mm) the     gumline will be visible about half of the time while the abutment margin placed further under     the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that     at delivery and follow-up, the abutment margin will not show intraorally.   "
81551|NCT02218528|"     The study is designed to determine the extent to which a plant-based ingredient is able to     modulate blood glucose response when administered with a meal.   "
81552|NCT02218515|"     The present study aimed to evaluate the effects of enamel matrix derivatives either alone or     combined with autogenous bone graft applied to intrabony defects in chronic periodontitis     patients on clinical/radiographic parameters and gingival crevicular fluid transforming     growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test     whether the use of autogenous bone graft and enamel matrix derivative combination in the     treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical     parameters in comparison to the use of open flap debridement alone.   "
81553|NCT02218502|"     This study is performed to compare the diagnostic performance and cost-effectiveness of     different diagnostic methods for differentiating benign from malignant adnexal (ovary or     Fallopian tube) masses: the Risk of Malignancy Index (RMI) will be compared with a two-step     triage test called simple ultrasound-based rules supplemented -if necessary- with either     subjective assessment by an expert sonographer or Diffusion Weighted - Magnetic Resonance     Imaging (DW-MRI). The investigators will test the hypothesis that this two-step triage test     will have better diagnostic accuracy than the RMI and therefore will improve the management     of women with adnexal masses.   "
81754|NCT02215876|"     This is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in     patients with operable, HER2-negative, breast cancer.   "
81555|NCT02218476|"     The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be     randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn     at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified     leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes     operated on various prothrombotic/proinflammatory parameters and their associated     intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity;     mitochondrial antioxidant system characterization; Expression levels and activity of     transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2),     Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs     microarrays, RT-PCR validation and correlation/association studies. 6) Induction of     over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.   "
82011|NCT02212496|"     Although there has been increasing interest in the association between cancer and     cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still     not fully understood. The aim of this study is to investigate the stroke mechanisms in     patients with cancer-associated stroke.   "
81558|NCT02218424|"     This study is a double-blind randomized controlled trial using intravenous magnesium versus     placebo to determine if systemic magnesium can decrease postoperative pain in pediatric     patients undergoing tonsillectomy.      Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg     bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of     normal saline bolus followed by infusion (placebo).      The primary objective is to determine if systemic magnesium will decrease postoperative pain     in patients undergoing tonsillectomy. The secondary objectives will determine if systemic     magnesium administration is associated with a decrease in opioid-related side effects,     decrease the incidence of emergence delirium, and improve postoperative functional recovery.      The study hypothesis is that the use of intravenous magnesium will decrease postoperative     pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and     improve functional recovery in patients undergoing tonsillectomy.   "
81559|NCT02218411|"     The purpose of this study was to evaluate the effects of a video-supported group-based Otago     exercise programme intervention on balance, mobility, physical performance and aerobic     endurance in community-dwelling older adults 65+ years old.   "
81560|NCT02218398|"     Investigators developed a test to assess the bronchodilator effects in mechanically     ventilated chronic obstructive pulmonary disease patients by comparing the change of airway     resistance. No matter whether patients respond to bronchodilator or not, they are randomized     assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then     investigators could objectively decide whether individual patients need or benefit from     bronchodilator administration.   "
81561|NCT02218385|"     The purpose of this study is to measure the performance characteristics for the collection,     fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE     Breast Aspirator across 3 independent labs and the National Reference Laboratory for Breast     Health (NRLBH). The study hypothesis is that each lab will have a specimen acceptability rate     of at least 90%. If it is assumed that the true level of acceptability testing is     approximately 96%, then the lower bound of a one-sided 95% confidence interval is expected to     be at least 90%.   "
81562|NCT02218372|"     The purpose of this study is to investigate the clinical response to fidaxomicin oral     suspension or tablets and vancomycin oral liquid or capsules in pediatric subjects with     Clostridium difficile-associated diarrhea (CDAD). It will also investigate the     recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well     as acceptance of the fidaxomicin oral suspension formulation.   "
81563|NCT02218359|"     To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin     Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with     Gram-negative and / or Gram-positive bacterial colonization.   "
81564|NCT02218346|"     AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small     molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer     treatment.      Administration of oral drugs with food may change the absorption of drugs, and it is     therefore useful to characterize the effect of food early in drug development.   "
81565|NCT02218333|"     The aim of the present study is to investigate effects of milk on body composition and muscle     strength, inflammation, appetite, DNA damage/repair and PBMC whole genome transcriptomics in     elderly subjects.   "
81566|NCT02218320|"     This is a Phase IV, open label, observational study to compare the gastrointestinal tissue     concentrations, inflammatory response, and viral replication of two integrase-inhibitors,     raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in     blood plasma. The study will be comprised of 20 HIV-infected volunteers who will be enrolled     equally into two groups. Group A will consist of 10 subjects receiving an antiretroviral     regimen of tenofovir, emtricitabine, and raltegravir, and Group B will consist of 10 subjects     receiving an antiretroviral regimen of tenofovir, emtricitabine, and dolutegravir.     Participants will provide small pieces of tissue, or biopsies, which will be taken from three     distinct locations of the large intestine during a colonoscopy procedure. These biopsies will     be used to measure the amount of raltegravir or dolutegravir, HIV virus, and inflammatory     markers present in the gastrointestinal tract.   "
81567|NCT02218307|"     Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation     with mupirocin is more effective than saline irrigations alone in reducing symptoms of     chronic rhinosinusitis in the early postoperative period.   "
81568|NCT02218294|"     The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by     mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made     by the body, the chemical composition of these metabolites and their profile over time in     blood and urine will be determined.   "
81569|NCT02218281|"     The recent Surgeon General's Report calls for effective and readily available treatment     approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for     connecting adolescent smokers with smoking cessation assistance. This study will adapt the     Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking     cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps     teens stop smoking compared to another teen smoking cessation app that does not include     mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen     would be relatively easy to disseminate widely and have tremendous public health significance   "
81570|NCT02218268|"     Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of     65 children with Type I diabetes mellitus. This prospective, crossover study will help     determine if there is an acute increase in arterial stiffness in children with Type I     diabetes mellitus who do not give extra insulin to cover a meal. This will give more support     to show why it is so critical to bolus every time they eat and to bolus on time to decrease     cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving     insulin before a meal compared to not giving insulin before a meal will be associated with     lower arterial stiffness in children with type I diabetes.   "
81571|NCT02218255|"     The purpose of this clinical investigation is to gather pilot data to evaluate the impact of     using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on     clinical pregnancy rates.   "
81572|NCT02218242|"     All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will     receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph     node dissection. After completion of the standard of care, intraoperative ultrasound will be     used to evaluate lymph node stations for the presence of any missed lymph nodes with     particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data     will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of     ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is     hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted     thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes     in non-small cell lung cancer patients undergoing definitive surgical resection.   "
81573|NCT02218229|"     The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.     The purpose of this study was to assess the effect of extracorporeal shock wave therapy on     carpal tunnel syndrome.   "
81574|NCT02218216|"     This hypothesis-generating feasibility study to determine potential associations between a     broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and     clinical findings involved in mild traumatic brain injury (mTBI). These associations will be     examined over the acute and sub-acute period (baseline to 3 months) following injury to     provide information useful for optimization of MR pulse sequences for mTBI applications.      The intent of this study is to broadly generate a range of potential mTBI biomarkers     detectable using investigational MR pulse sequence technologies. Feasibility data attained in     this study may be used for engineering program decision-making and in support of future     scientific assessment, engineering development, published research databases or registries     mTBI data and images, and other purposes determined by the Sponsor. The results of this study     are not intended for use in regulatory submissions.      Subjects will be examined on commercially available MR scanner using investigational or     standard of care MR coils and a series of investigational Application Packs containing a     predetermined set of MR pulse sequences optimized by Sponsor   "
81575|NCT02218203|"     This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was     part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple     dose-combinations of chronic oral (PO)dextromethorphan and intravenous (IV) lidocaine in     central neuropathic pain following spinal cord injury.   "
81576|NCT02218190|"     The purpose of the study is to determine with Alvimopan reduces the incidence of post     operative ileus in patients who undergo posterior spinal fusion.   "
81577|NCT02218177|"     The purpose of this study is to evaluate the level of cytokines (which are small proteins     important in cell signalling) in eye fluid (aqueous humour) in patients with wet age related     macular degeneration patients who have been treated with an injection in the eye     (intravitreal injection) with a drug called ranibizumab. The level of cytokines will be     compared between patients who have a good response to ranibizumab treatment and patients who     are non-responsive to ranibizumab and need other forms of therapy. This knowledge will help     for the future treatment and to potentially develop new medication for wet age-related     macular degeneration.   "
81578|NCT02218164|"     The purpose of this study is to find out if the combination of two established anti-cancer     therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically,     investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and     Interferon alpha-2b (injection) can help people with advanced cases of squamous cell     carcinoma of the skin. For participants that are not approved for oral capecitabine, treating     physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon alpha-2b     have been used separately to treat squamous cell carcinoma of the skin and are FDA approved     in other cancer types.   "
81579|NCT02218151|"     Hematopoietic stem cell transplantation (HCT) has the potential to cure a variety of     malignant and non-malignant diseases. However, it is associated with significant morbidity,     and treatment-related mortality. This is due in large part to the prolonged pancytopenia and     immunosuppression associated with the preparatory regimen of chemotherapy and/or radiation     and the wait until engraftment of the transplanted hematopoietic stem cells. During this     vulnerable period, infectious complications are common. Historically HCT patients were kept     in protected environments to safeguard their health during the pancytopenic phase; despite     these measures, infectious complications and graft versus host disease (GVHD) remained common     and lead to significant morbidity and mortality after HCT. Currently patients are still     closely watched in the inpatient or day hospital environment, though recent practices allow     patients more freedom. This study randomizes eligible patients to receive post-transplant     care at home vs. in the hospital or clinic, per standard of care. The primary objective is to     compare the incidence of grade II-IV acute GVHD at 6 months in patients receiving     patient-centered medical home (PCMH) vs standard care.   "
81580|NCT02218138|"     Type 2 diabetes is a chronic disease that puts people at risk for major health problems like     heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there     has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor     insulin sensitivity, meaning that insulin - an important chemical the body makes to keep     blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving     insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed     have worse insulin sensitivity than individuals who do not feel stressed. In adults,     decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested     in teenagers. The purpose of this study is to find out if taking part in a brief group     program to decrease stress will improve insulin sensitivity and lower diabetes risk in     teenage girls.   "
81581|NCT02218125|"     The purpose of this study is to assess the safety and tolerability of Modified Vaccinia     Ankara (MVA) Mosaic vaccine in healthy adult participants.   "
81602|NCT02217852|"     Several surveys had revealed that Tibetan adults had high prevalence of hypertension.     However, there was no research studying the antihypertensive effect of the known drugs in     Tibetan. The main arms of our study were to determine if the efficacy of lowing blood     pressure and protecting target organ damage differs between nitrendipine and     Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of     lowing blood pressure and protecting target organ damage differs between captopril plus     Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.   "
81582|NCT02218112|"     The sympathetic nervous (SNS) and the renin angiotensin aldosterone system (RAS) have a     direct impact on renal hemodynamic, hormonal secretion and vasoactive peptide. Many     mechanisms including the SNS, RAS and renal sodium handling could explain the pathogenesis of     hypertension in obese patients. Lifestyle changes and bariatric surgery induce weight loss,     which is associated with blood pressure lowering in obese patients. A diminution in the renal     sympathetic stimulation and RAS activation could explain this effect.      The AIM of this study is to show that weight loss induced by bypass surgery in obese patients     affects renal salt excretion under  low body negative pressure (LBNP) conditions .      Secondary objectives are to investigate the impact of weight loss on renal hemodynamic     (glomerular filtration rate (GFR), renal plasma flow) and neurohormonal responses under  low     body negative pressure conditions . We will also analyse renal blood oxygenation with Blood     Oxygenation dependant IRM (BOLD-IRM) technique before and after weight loss.      The population of this study will consist in two groups including 36 patients. The first one     will include 24 obese patients that are going to undergo a bariatric surgery. The second one     will include 12 obese patients without any weight loss associated surgery.      Both group will undergo 3 investigation days. Each patient will have to undergo a screening     visit that will provide dietary advice to ensure a standardized salt intake (120-180     mmol/day) for the duration of the study. The first investigation will define baseline, the     second and third day of investigation will take place after 3 month and 12 month after     bariatric surgery for surgical patients or after baseline for patients without surgery. One     to two weeks before phase 1 and 3 patients will perform a BOLD-MRI. The surgery group will     undergo bariatric surgery between the first investigation phase (baseline) and the second. An     ambulatory blood pressure and 24-hour urine collection will precede each investigation day.     An investigation day consists in renal hemodynamics, neurohormonal and natriuretic response     measurements before, during and after 60 min of LBNP at -30mbar . The duration of the study     per subject is going to take 12 months.   "
81583|NCT02218099|"     This study consists of two parts. Part 1 evaluates the effect of renal impairment on the PK     and PD of a single dose of ASP8232. In addition, the safety and tolerability will be     assessed.      Part 2 evaluates the PK, PD, and safety and tolerability of multiple doses of ASP8232     compared with placebo in Type 2 Diabetes Mellitus (T2DM) subjects with Chronic Kidney Disease     (CKD).   "
81584|NCT02218086|"     Slacklines have been established in the last few years as a training equipment in sports such     as climbing, skiing and others to increase postural control. Furthermore, slacklines are used     in physiotherapy in terms of stabilizing training such as wobbling boards.      However, if slackline training is effective in rehabilitation has not been investigated yet.     Therefore, to goal of this study will be to investigate the effectivity of slackline training     in physiotherapy compared to a wobbling board with a single tilting axis.      Outcomes will be electromyographic-data and the kinetics of the whole body.   "
81585|NCT02218073|"     The purpose of this study is to evaluate the absolute bioavailability (the extent to which a     drug or other substance becomes available to the body) of JNJ-42756493 following a single 10     milligram (mg) dose as an oral solution administered in combination with a single intravenous     administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the     relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a     tablet (test) formulation in a crossover (method used to switch subjects from one study group     to another in a clinical trial) design in healthy participants.   "
81586|NCT02218060|"     Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a     patient is suspected of having coronary artery disease. The test, however, requires     relatively high levels of radiation, which have been linked to DNA damage and cancer, and the     use of contrast material, which can affect kidney function. The SOMATOM Force, a new     third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds     the potential to obtain quality images while also reducing radiation dose and contrast     material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting     coronary artery disease and also see if radiation dose and contrast material are reduced     compared to the previous 2nd generation scanners. It is suspected that the Force will provide     clinical quality images while decreasing radiation dose and contrast material required.   "
81587|NCT02218047|"     Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic     increase of red blood cells and frequently also of white blood cells. The thickening of the     blood in relation with a modified function of the cells has several consequences like     increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the     brain as well as fingers and toes and an increased risk of arterial and venous thrombosis     (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction,     deep vein thrombosis in the legs. In case of a strong increase of platelets there is an     additional risk of bleedings. As the disease progresses the size of spleen and liver     increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a     progression at a later time point to a leukemia (increased formation of white blood cells)     can occur.      The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon     alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm     is receiving best available therapy as selected by the investigator. Response to the     treatment is measured by several blood parameters as well as size of the spleen.      Interferon-alpha has been shown to be effective in controlling the blood parameters by     immunologically influencing the blood building cells. This can lead to a suppression of the     disease-causing stem cells and help healthy stem cells to proliferate. Through this mechanism     it is possible that Interferon-alpha can avoid long-term damaging effects of the disease.   "
81588|NCT02218034|"     This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne     vulgaris.   "
81589|NCT02218021|"     The purpose of this study is to evaluate the abuse potential and safety of samidorphan in     healthy, non-dependent, adult, recreational opioid users.   "
81590|NCT02218008|"     This study will evaluate the efficacy and safety of ALKS 5461.   "
81603|NCT02217839|"     This multi-ascending dose study is designed to investigate the safety, tolerability,     pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48     healthy volunteers.   "
81604|NCT02217826|"     In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with     the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and     placebo control. The main purpose of the study was to investigate the effects of each     treatment on the control of plasma glucose as well as the secretion of insulin and glucagon     following a standard meal.   "
81605|NCT02217813|"     Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis     blood concentrations will be measured periodically for one week. After about 20 days,     subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis     concentrations from the two different formulations will be compared to determine if they are     approximately the same.   "
81591|NCT02217995|"     Obsessive Compulsive Disorder (OCD) is a chronic and debilitating disorder known to have     reported lifetime prevalence in the range of 2%. OCD is most commonly treated with Cognitive     Behavioural Therapy (CBT) and/or pharmacotherapy. However, some studies suggest challenges     with CBT in retaining gains long term, and while 60-80% of OCD patients respond to SRI     treatment, partial symptom reduction is substantial. Investigations into the effectiveness of     alternative, cost-effective treatment modalities are thus needed. Mindfulness, defined as     paying attention in a particular way (on purpose, in the present moment and nonjudgmentally),     promotes awareness and attention to internal experience and has been shown to reduce symptoms     of anxiety and depression. A number of controlled studies have found Mindfulness-Based     Cognitive Therapy (MBCT) to be effective for depression, social anxiety disorder, and     generalized anxiety disorder, but few have tested its effect on obsessive compulsive disorder     (OCD). Moreover, those studies examining MBCT in OCD focused on clinical case studies and     non-clinical samples. This study proposes to examine the effect of MBCT in clinical practice,     in a randomized sample of patients with OCD whom are on a clinic wait list. As patients are     allocated to the wait list, they will be randomly assigned to receive either 10 weeks of     group MBCT or wait list as per usual. It is hypothesized that subjects randomly assigned to     the MBCT treatment group, compared to those in the wait list control group, will see greater     reductions in self-reported measures of OCD symptom severity and improvement in other     measures of mindfulness, mood and level of functioning. The results of this pilot study, if     successful, will provide evidence towards another route by which patients can improve their     OCD while waiting for clinic services or consultation. Results will also lend more evidence     as to whether MBCT is effective as a stand-alone treatment for clinical OCD, which will     inform further investigations into the potential addition of mindfulness techniques to     standard care.   "
81592|NCT02217982|"     Single site, open label, randomized design in patients with relapsing forms of Multiple     Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS     scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF),     including the titration period.      After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any     category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be     reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater     than or equal to 3.5 in at least one of the key categories will be randomized to a standard     therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period     will be terminated from the study at this visit. Patients with an average reported MAGIS of     greater than 6.5 at Baseline will be placed in the treatment arm.      Patients who are randomized to the treatment arm will be instructed to take 125 mg     simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each     DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will     also be instructed to take 2 mg loperamide three times daily.      Patients randomized to the standard therapy arm will be instructed to follow the normal     dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms     (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the     treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the     past 24 hours using the MAGIS scale once daily.      Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily. Patients     will return to the clinic at Week 3 and Week 6/End of Treatment for diary and compliance     review. After Week 6, patients will be instructed to return to a standard therapy. MAGIS will     be recorded for one more week and collected at Week 7/End of Study.   "
81593|NCT02217969|"     Patients undergoing anesthesia for non-cardiac surgery will be randomized to either having     their anesthesia team alerted or kept blinded to extended periods of less than normal blood     pressure with the goal of studying if providing these alerts leads to improved outcome after     surgery (lower risk of death or complication in the days and weeks following surgery).   "
81594|NCT02217956|"     HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few     studies have been published on the use of HCIP in peritoneal carcinosis from ovarian     background but most of them were non-randomized phase II studies on a small population using     different type of drugs and dosage. before this heterogeneity it seems necessary to     standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian     background   "
81595|NCT02217943|"     The primary goal of this study is to assess impact of metabolic surgery on glycemic control     in diabetic patients.   "
81596|NCT02217930|"     The study designed to determine the effect induced by WCK 2349 on the QT interval.      The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2)     to assess the safety of high doses of single-dose administration of WCK 2349 on the QT     interval.   "
81597|NCT02217917|"     This is a 2 part study designed to provide an initial assessment on the safety, tolerability,     and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part     2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of the study will be     conducted using a cross-over design while Part 2 of the study will be conducted using a     parallel design.   "
81598|NCT02217904|"     This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral     therapy (ART) activity of MK-8591 monotherapy in ART-naive, human immunodeficiency virus-1     (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of     MK-8591, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from     baseline between MK-8591 and placebo is at least 0.5 log (base10) copies/mL.   "
81599|NCT02217891|"     The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this     research gap by examining MSK patients' attitudes, preferences, and information needs     regarding incidental findings arising from tumor genomic profiling.   "
81600|NCT02217878|"     The purpose of the IMPRESSION study is to determine whether intravenous administration of     morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction     (STEMI) patients and in non-ST-segment elevation myocardial infarction (NSTEMI) patients     alters the plasma concentrations of ticagrelor and its active metabolite and whether it is     associated with any negative impact on the antiplatelet effect of ticagrelor.   "
81601|NCT02217865|"     The long-term goal of this research is to develop new tools to guide patients, caregivers,     and clinicians in making individualized decisions regarding colorectal cancer (CRC)     surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract,     investigator will analyze surveillance data to determine the effectiveness of CRC     surveillance and recurrence risk taking into account different patient and tumor     characteristics; identify key issues about CRC surveillance important to patients,     caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a     patient-centered, risk stratified surveillance strategy by creating an interactive decision     aid for use by patients and clinicians.      This protocol addresses a formative step in the creation of the interactive decision aid     where patients' information needs and preferences are assessed regarding decisions about     surveillance.      The specific aims of this protocol are:      Phase 1 - To interview patients and their caregivers to determine their concerns, preferences     and key priorities regarding surveillance after curative resection of colorectal cancer, and      Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys     with patients and caregivers.   "
81643|NCT02217319|"     It has been shown that the use of volatile anaesthetics, that are usually used to perform a     general anesthesia, have cardioprotective properties. This has been shown in animal studies     and in patients that underwent cardiac surgery. The aim of our study is to examine if     Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.   "
81611|NCT02217735|"     This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to     neutral writing in individuals with Parkinson's Disease and their support persons.     Participants will be randomly assigned to complete three, 20 minute sessions of expressive or     neutral writing. Participants will complete evaluation of outcomes at baseline, immediate     post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of     these therapies on thinking abilities, physical health, and patient and support person     ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is     hypothesized to result in greater improvements and/or stability of function on     neuropsychological tests of attention, working memory, learning, and memory skills compared     to the neutral writing condition.      Results from this study will determine whether brief writing exercises are easily used by and     beneficial for individuals with Parkinson's Disease and their support persons. If positive     benefit is observed, information from this study will be used to further optimize these     therapies for larger trials designed to evaluate the value of the therapies for individuals     with Parkinson's Disease and their support persons.   "
81612|NCT02217722|"     The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of     Remission. The investigators have postulated that we developed could be beneficial for     patients with Ulcerative Colitis. To date, no study has explored this possibility.   "
81613|NCT02217709|"     This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that     has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of     antidepressant that works by decreasing the amount of a protein called monoamine oxidase     (MAO). MAO drugs may have an anticancer effect in prostate cancer.   "
81614|NCT02217696|"     The long-term goal of this study is to improve prediction of poor reading outcome at     preschool age by using a combination of behavioural and neuroimaging measures and to evaluate     a specific computerized training program to support children with problems during reading     acquisition.   "
81615|NCT02217683|"     The objective of this study is to assess if prolonged storage time of a packed red blood cell     unit may cause pulmonary vasoconstriction after transfusion, in a susceptible population such     as cardiac surgery patients. The investigators will also evaluate the potential reversal     effect of Inhaled Nitric Oxide on pulmonary vasoconstriction induced by stored blood     transfusions.   "
81616|NCT02217670|"     The main purpose of this study is to assess comparative bioavailability of a test formulation     of Metformin HCl 1000 mg granules manufactured by Indeus Life Sciences Pvt. Ltd., Mumbai     India (An Affiliate Of Disphar International B.V., The Netherlands) relative to Glucophage     1000 mg film-coated tablets of Merck GmbH, Austria in 54 healthy adult subjects under fed     conditions. The second aim is to asses the safety of subjects and to determine other     pharmacokinetic data.   "
81617|NCT02217657|"     This prospective, randomized study will investigate, if information of the catheter force     during ablation of a left anterior line does reduce total RF application time by prevention     of ineffective lesions.   "
81618|NCT02217644|"     -  Investigation of safety and tolerability of BI 653048 H3PO4 following the administration          of single rising doses of an aqueous solution in healthy male subjects        -  Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the          investigation of dose proportionality        -  Investigation of relative bioavailability of capsules versus aqueous solution   "
81619|NCT02217631|"     The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and     pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.   "
81622|NCT02217592|"     This is an observational study to identify the aetiology and factors associated with outcome     of community-acquired sepsis and severe sepsis in Northeast Thailand.      Potential study participants will be adult patients who are presented at the hospital with     community-acquired sepsis. Clinical specimens (including blood, urine, sputum and throat     swabs) will be collected from each participant on admission for culture, PCR and serological     tests, and other laboratory tests, including inflammatory markers and genotyping.     Participants' treatment will be closely monitored during the duration of their hospital stay.     Blood will be again collected at 72 hours after admission. Participants will be contacted at     28 days after admission to determine clinical outcome by phone interview with standardized     script.      There will be a total of 5,020 patients enrolled in this study over 3 years.   "
81623|NCT02217579|"     The metabolic syndrome is rising worldwide as a consequence of the continued obesity     epidemic. The current obesogenic environment makes the regulation of energy intake difficult     and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb     hunger and reduce energy intake are critically needed. We hypothesize that inclusion of     protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity     adults.   "
81624|NCT02217566|"     The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen     (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer     cells from one part of the body to another) castration (any action, surgical, chemical, or     otherwise, by which a male loses the functions of the testes) resistant prostate cancer     (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC),     chemo-naive (treatment of cancer is not done using drugs), who received a prior     diethylstilbestrol therapy (DES).   "
81625|NCT02217553|"     Platelets play pivotal role in atherosclerosis and acute cardiovascular events. Platelet     hyperreactivity and increase platelet-monocyte aggregate (PMA) formation are found in HIV     infected patients, which may contribute to the excess cardiovascular risk. Low level of     vitamin D has been associated with the presence of cardiovascular diseases. The aim of our     study is to determine the effect of vitamin D supplementation on platelet activation,     platelet reactivity and platelet-leukocyte complex formation in asymptomatic HIV-infected     patients treated with ART   "
81652|NCT02217202|"     The aim of the study is to determine whether the AQUACEL™ Ag SURGICAL cover dressing is     successful in reducing the incidence of wound infection in high risk patients following total     knee replacement. We will also look at the status of the wound, occurrence of blistering,     biochemistry results, dressing wear time and the number of dressing changes to quantify the     dressing performance.   "
81626|NCT02217540|"     Objective: To pilot the methods proposed for conducting a full randomised clinical trial to     evaluate the effect of Mulligan concept mobilization with movement on shoulder functionality     in older adults with shoulder dysfunction.      Design: Pilot randomised, single-blinded clinical trial. Setting: Three nursing homes,     Toledo, Spain. Participants: 44 older adults with shoulder dysfunction. Interventions:     Participants will be randomly allocated into control group (n=22) treated with a     physiotherapy standard protocol proposed by the Spanish Rheumatology Society; and     experimental group (n=22) treated with the same physical therapy standard protocol and     Mulligan concept mobilisation with movement. Both interventions will take place three times a     week for 2 consecutive weeks.      Main outcomes: Primary outcome is shoulder functionality measured with Shoulder Disability     Questionnaire (S-SDQ) Spanish version, and secondary outcomes are active glenohumeral range     of motion and pain intensity. Data will be collected at baseline, after each group     intervention, and 1 and 3 months after finishing interventions.   "
81628|NCT02217514|"     Evaluation of the long-term (48 h) and short-term (1 h) effects of BI 44370 BS on the     pharmacokinetics of midazolam as marker of a possible inhibition of CYP 3A4; safety and     tolerability.   "
81629|NCT02217501|"     The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of     aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will     lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction     (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at     end of study treatment.   "
81630|NCT02217488|"     This clinical trial investigated the safety, tolerability and pharmacokinetic profile of     DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1     study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via     single dose subcutaneous injection.   "
81631|NCT02217475|"     The purpose of this study is to determine whether Cenicriviroc is effective and safe in the     treatment of nonalcoholic steatohepatitis (NASH) in adult subjects with liver fibrosis.   "
81632|NCT02217462|"     The primary purpose of this observational cohort study is to examine the role of food     reward in maternal diet and weight change during pregnancy and postpartum. The study will     further examine the importance of food reward in the context of behavioral control and other     related aspects of eating behavior, as well as weight-related biomedical, psychosocial and     behavioral factors including genetics, physical activity, stress, sleep and depression. Four     hundred and fifty women of varying baseline weight status will be enrolled early in pregnancy     (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments will occur at     baseline (<12 weeks postpartum), during pregnancy at 13-18 weeks gestation, 16-22 weeks, and     28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months. Measures will     include assessments of food reward and related constructs, dietary intake, other health     behaviors, and anthropometrics. Clinical data and biological specimens will be obtained.     Infant anthropometrics and feeding practices will also be assessed. Primary exposures include     aspects of food reward and behavioral control, which will be assessed in multiple ways to     maximize information and utility. Primary outcomes include gestational weight gain,     postpartum weight retention and dietary quality.   "
81633|NCT02217449|"     To assess the accuracy of predicting histology with virtual chromoendoscopy for distal     colorectal polyps according to the ASGE PIVI statement.   "
81716|NCT02216370|"     Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence     about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could be     present but not revealed by rutinne ECG.   "
81634|NCT02217436|"     Children aged 2-12 presenting to the Rady Children's Hospital San Diego (RCHSD) emergency     department with facial lacerations requiring suture repair will be eligible to participate in     the study. Participating children will be randomized to standard care versus standard care     plus iPad use during the procedure. Children's anxiety levels assessed using a validated     scale will be measured from video recordings made of the procedure. Parent and provider     satisfaction surveys will be completed following the procedure. The primary study aim is to     determine how iPad use affects children's anxiety levels during facial laceration repair. The     secondary study aim is to determine how iPad use affects parent and provider satisfaction     regarding a child's facial laceration repair. Hypothesis is that iPad use decreases     children's anxiety levels during facial laceration repair and increases parent and provider     satisfaction regarding a child's facial laceration repair.   "
81635|NCT02217423|"     The purpose of this study is to determine whether the hospitalized patients with increased     waist circumference exhibit cardiorespiratory alterations after chest physical therapy.   "
81636|NCT02217410|"     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK)     and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar     rate of acute rejection prophylaxis and renal function in a de novo renal transplant     population receiving an allograft from standard criteria donors.   "
81637|NCT02217397|"     Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during     sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was     the standard therapy, especially those with daytime sleepiness and cardiovascular     comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high     pressure was often reported. Instead, oral appliance (OA) was the alternative for those who     could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in     compared with CPAP, but OA is more tolerable and acceptable in OSA patients.      Only one observation study addressed the effects of the combinations of OA and CPAP in OSA     patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA     patients and could decrease CPAP pressure. However, the study enrolled the patients with CPAP     intolerance according to the subjective chief complaint, not the objective CPAP pressure     data. In the present study, we studied the effects of combinations of CPAP and OA for     patients with severe OSA who could not tolerate CPAP with high-pressure setting.   "
81653|NCT02217189|"     Although several studies have considered the relationship between infertility and semen super     oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as     oral zinc supplementation on superoxide radical scavengers activity which are important in     fertility of the individual has been reported.   "
81638|NCT02217384|"     Background. Anorexia nervosa (AN) still carries the highest fatality rate of any psychiatric     disease, and less than half of the patients recover, completely refractory to any treatment.     The etiology remains unknown and evidence for treatment is lacking. The intestinal microbiota     and its microbiome provide humans with additional gene products which may be regarded as an     organ, which contributes to multiple host metabolic pathways. Recent advances in microbial     DNA sequencing technologies have resulted in metagenomic DNA analysis of whole ecosystems     such as the human gut. Altered intestinal microbiota has been related to obesity and insulin     resistance. Hypothetically, the intestinal microbiota could play a role in the generation     and/or maintenance of the emaciation in AN.      Aim. The aim of the present study is to investigate whether gut microbiota is altered in     patients with AN.      Subjects and methods. A cross sectional study of the gut microbiome profiles in 75 clinical,     psychometric and biochemical well characterized treatment seeking females with AN. The     microbiome profiles are compared with 75 age- matched healthy Danish control subjects.      Perspectives. Clarifying whether the intestinal flora is implicated in the susceptibility to     or maintenance of AN may provide the basis for development of new highly required treatments.   "
81639|NCT02217371|"     In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of     Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without     Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep     disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or     Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep     disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus,     we wish to determine potential changes in the regulation of sleep / wake cycle through a     protocol of extended wake.      The principal objective is to compare the objective sleepiness in sleepy patients with ADHD     and healthy subjects during a protocol of extended wake.      It's an observational study of interventional type realized in patient with ADHD syndrome     deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the     implication of the homeostatic and circadian systems in the preservation of awakening.   "
81640|NCT02217358|"     The aim of the project is to compare NBI endoscopy and standard endoscopic method using white     light and evaluate accuracy both methods in early detection and diagnosis hypopharyngeal and     laryngeal precancerous and cancerous lesions. A higher contrast between the mucosal     epithelium and blood vessels is achieved in NBI endoscopy using filtered light comparing to     white light observations. This allows detection of small mucosal changes, few millimetres in     diameter, which are not observable using white light. The second aim in patients with     squamous cell carcinoma of the upper aerodigestive tract is to compare extension of mucosal     lesions by evaluation of NBI endoscopy and white light endoscopy, which is crucial for     perform targeted biopsy and for determination of resection margins in cancer surgery. The     investigators expect that dysplastic changes of mucosa or early laryngeal cancerous lesions     are detected in white light endoscopy rarely. In case our hypothesis is confirmed, frequency     of precancerous and early cancerous lesions of hypopharynx and larynx is more common in     patients with non-specific symptoms of laryngeal and pharyngeal diseases.   "
81641|NCT02217345|"     Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of     alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates     of about 30% of individuals in the United States. A subset of these will develop progressive     disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis     and liver failure. NAFLD is expected to be the most common indication for liver     transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will     decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy     (1H-MRS).   "
81642|NCT02217332|"     Phase 2, open-label, multi-center study to evaluate the clinical effects of oral     administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal     polyps and eosinophilia.   "
81644|NCT02217306|"     Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be     modified by different pathologies or by age. The purpose of this study is to identify the     changes that could be in relationship with the course of diabetic retinopathy comparing with     diabetic patient without retinopathy and in patients with diabetic macular edema so if it is     a difference, research for therapeutic strategies to improve it in this patients.   "
81645|NCT02217293|"     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although     many conservative forms of management including the use of wrist splint, steroid injections     and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or     short-lived.      Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade,     was found to be able to alleviate pain for certain kinds of chronic pain conditions without     damaging nerve. However, the application of PRF in CTS is scarce.      The purpose of this study was to assess the analgesic effect and prognosis of     ultrasound-guided PRF in the median nerve in patients with CTS.   "
81646|NCT02217280|"     This study will analyze injectate dispersal patterns after standard-of-care cervical epidural     steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to     characterize the pattern. Although these procedures are performed with high frequency under     the assumption that injectate remains localized to injection site, no peer-reviewed studies     have validated this assumption. Comprehensive characterization of injectate dispersal     patterns will provide important data regarding safety, as well as diagnostic and therapeutic     potential of cervical epidural steroid injections.   "
81647|NCT02217267|"     The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when     compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6     months) at 3 months after first time of infusion   "
81648|NCT02217254|"     It is an unproven assumption that at least 2 cryoablations is necessary in each pulmonary     vein for successful ablation of atrial fibrillation. The investigators hypothesize that a     single cryoablation in each pulmonary vein that achieves isolation may leads to equivalent     efficacy with decreased risk. The One Freeze Study evaluates this hypothesis.      This study compares one 3-minute cryoablation per pulmonary vein versus two 3-minute     cryoablations per pulmonary vein during atrial fibrillation ablation procedures.   "
81654|NCT02217176|"     Internal jugular venous catheterization is a challenging procedure in pediatric patients due     to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA)     may jeopardize the success and increase the complication rate.However, the use of ultrasound     as an assistance tool might be helpful to identify the relationship between the IJV and the     CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the     airway management during general anesthesia for central venous catheterization. In this     observational study, the investigators aimed to investigate the impact of the laryngeal mask     insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV     and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical     procedure.   "
81655|NCT02217163|"     Patients with high risk multiple myeloma have shorter remission periods and reduced overall     survival. Prognostic significance of minimal residual disease negative remission is being     highlighted in many of the newer studies.      The current phase 2 study investigates the combination of carfilzomib together with     cyclophosphamide and dexamethasone in patients with high risk multiple myeloma in younger     transplantation eligible patients.   "
81656|NCT02217150|"     Prospective clinical series to gather post tumor ablation clinical outcomes from subjects     with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment     with the STAR™ Tumor Ablation System.   "
81657|NCT02217137|"     Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are chronic systemic     autoimmune diseases that have been reported to affect the ocular surface of patients [1,2].     However, the nature of the disturbances of the ocular surface immunity and their relationship     to systemic disease severity are poorly understood.      This study aims to profile the ocular surface inflammation of RA and SLE patients by a.,     analysing levels of tear cytokine, and b., investigating conjunctival cells, and c. clinical     imaging for conjunctival redness and tear stability.      20 consecutive RA patients and 20 consecutive SLE patients will be recruited from the     Singapore General Hospital Rheumatology clinic. 20 age matched controls for SLE and another     20 age matched controls for RA will be recruited.      All participants will undergo        1. Tear collection with Schirmer strips        2. EyePRIMTM (Opia Technologies) Impression Cytology Device for conjunctival sampling        3. Clinical ocular surface assessment with Oculus Keratograph 5M        4. Collection of blood via venipuncture (optional)        5. Retrieval of Clinical Information of participants      The association of cytokines in the tears with various cellular and immune markers, as well     as clinical signs of inflammation and tear stability will be investigated. This will be     useful for further longitudinal studies of treatment in autoimmmune disease patients.   "
81658|NCT02217124|"     The primary objective of the proposed research is to determine the influence of 8 weeks of     twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat     120kcal muffin on components of obesity (waist circumference [waist measurement], serum     glucose [blood sugar], triglycerides [fats in the blood] and HDL-cholesterol, and blood     pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight     and obese individuals. A total of 48 children aged 10-16 years will be randomly assigned to     groups and provided with twice daily 120 kcal servings of either dried apples or muffins for     8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood     samples will be collected and analyzed. During each visit to the lab, subjects will be     weighed in minimal clothing, tested for body composition using dual energy X-ray     absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod     Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will be     performed prior to initiation of the study; one recall will be performed throughout the     feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients,     vitamins and minerals will be assessed to determine diet quality. All food records will be     analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the     study include determining the effects of consistent snacking and particular snack foods on     metabolism and weight management. There are no major risks to subjects in this study. There     are minimal risks when performing venipuncture (blood draws) including bruising, perforation     of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of     needles, and infection. This study will hopefully allow more understanding and insight into     the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized     that the twice a day apple snack group will have decreased waist circumference, body     adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at     the end of 8 weeks.   "
81659|NCT02217111|"     The purpose of this prospective study is to obtain preliminary data on changes in pre-post     voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a     series of cognitive operations. The primary outcome is voice-related quality of life     (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived     from sustained vowel and running speech samples.   "
81660|NCT02217098|"     The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate     when used for the treatment of occlusal and proximal caries in primary molars with ART under     field conditions.      This research will be done under field conditions in Barueri, a city in the state of São     Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the     restorations and teeth will be evaluated by two independent evaluators. Only children whose     parent or representative who have signed an informed consent are included in this     research.The ART treatments will be done by two dental students. The operators will receive     the same ART-training. The children will be randomly assigned to one of the operators. The     restorative material to be used in each child will be assigned by another random list. It     will be performed descriptive analyses to describe the sample. Bivariate analyses will be     performed to test the hypothesis. The data will be analyzed with a chi-square test to compare     the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator     effect, the influence of the cavity size on the survival rate, the position of the tooth, the     dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative     conditions. The effect of these variables on the survival rate will be evaluated using a     regression analysis.   "
81661|NCT02217085|"     The purpose of this study is to determine the best way to ensure that polyps are completely     removed by evaluating the borders of the removed polyp. If a polyp is found that meets the     size requirements for the study, the investigators will take extra biopsies of the margin to     determine if there is any abnormal tissue or cancer at these borders.   "
81662|NCT02217072|"     A Randomized controlled study of two different educational support interventions developed     for children in foster care (age 6-13).   "
81663|NCT02217059|"     The purpose of this study is to evaluate the Congruence of Emergency Department (ED)     Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.   "
81666|NCT02217020|"     The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation.     However, preoperative radiation cause kinds of adverse events, some were irreversible. And     the survival benefit was not obvious. Whether chemotherapy alone is effective enough in     treating rectal cancer is not yet known. Here, the investigators chose all the three active     cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen     (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant     regimen in treating patients with locally advanced rectal cancer.   "
81667|NCT02217007|"     This is an open-label study of SNC-102 (acamprosate calcium sustained release tablet) in     adult subjects with Tourette Syndrome. Subjects will be treated with oral doses of SNC-102     800 mg on a BID basis - before breakfast and at bedtime - for 4 weeks and the same subjects     will be treated with SNC-102 1600mg in the morning and 800mg in the evening for an additional     4 weeks. Subjects will be assessed for changes in tic severity, safety, and pharmacokinetics.     The study hypothesis is that treatment with SNC-102 will improve the tic severity in adult     subjects with Tourette Syndrome.   "
81668|NCT02216994|"     1. The investigators previously reported a simple diagnostic scoring system to          differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders (HAD)          in the patients with suspected intestinal dysganglionosis. In the retrospective study,          the investigators concluded that the patients with a predicting score of more than 5 are          more likely to be diagnosed with HD, whereas a score less than 5 is mostly indicative of          HAD.        2. Since it is essential to confirm the accuracy and efficacy of the scoring system in a          prospective manner before it is used as a standard procedure, this prospective study is          designed and performed.   "
81717|NCT02216357|"     The primary objective of the study is to determine the safety of oral ifetroban compared to     placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of     Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin     challenge.   "
81718|NCT02216344|"     The primary objective of the study is to validate the proposed claims for the OxiCable     device, for pulse rate and saturation accuracy in a diverse subject population over a     specified saturation range.   "
81669|NCT02216981|"     The purpose of this study is to examine how feasible and acceptable it is to deliver a     talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for     people who have had treatment for OCD in the past but it didn't work out for them.      The two different treatment formats are CBT delivered on a weekly basis (which is     approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session,     followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format     (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by 1-3     monthly follow up sessions as needed).   "
81670|NCT02216968|"     The purpose of this study is to test the feasibility of an innovative approach to increase     the amount of vegetable's (V) intake consumed by preschool children who are predominately     African-American (AA) and Hispanic-American (HA).   "
81671|NCT02216955|"     China has the largest gastric cancer patients population all over the world. Recent reports     concluded nutrition status and lifestyle factors were associated with gastric cancer risk,     however, the influence of nutrition and lifestyle factors on cancer outcome in gastric cancer     survivors is largely unknown.The investigators will explore the impact of nutrition status,     life style, dietary pattern, obesity, physical activity, depression, diabetes, aspirin use     and vitamin supplement on gastric cancer outcome. The investigators will recruit     approximately 50,000 patients as a prospective study cohort. During follow up, the     investigators will explore the association of these factors with disease-specific survival,     disease-free survival and overall survival of patients. The investigators believe that this     project will facilitate the establishment of domestic nutrition and lifestyle data of gastric     cancer of China, and the improvement of the quality of clinical management of patients with     gastric cancer.   "
81672|NCT02216942|"     The maintenance of primary teeth until their exfoliation has been one of the main purposes of     Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the     permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous     teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to     conduct a randomized clinical trial with longitudinal follow-up of two years, double blind,     to compare the degree of success of endodontic treatment in primary among the most used     folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.   "
81673|NCT02216929|"     The demographic data, mortality rates and clinical diagnoses of the patients who were     evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent     consultation call from the emergency department in 2010-2011.      Primary outcome: an examination of demographic data, predicted mortality rates and the     clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio     Inclusion criteria: patients throughout the hole hospital whom was intubated by the     anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who     refused treatment   "
81683|NCT02216799|"     Hyperglycemia increases the risk of complications in surgical patients. Focus on poor     glycemic control as a contributor to adverse outcomes in settings outside the intensive care     unit (ICU) is often dismissed. Total parenteral Nutrition (TPN) has been used in providing     surgical patients with nutrition to prevent deterioration of nutritional status. However,     many diabetic patients receiving TPN develop exaggerated hyperglycemia that requires frequent     insulin administration via sliding scale. Providing diabetic patient's receiving TPN basal     insulin is a known strategy to aid in blood sugar control and prevention of high blood sugar     spikes. Many strategies for basal insulin provision have been utilized clinically during the     administration of TPN; this includes the incorporation of insulin with TPN solution or     administration of long acting insulin such as glargine. However, no study has compared any of     these strategies aiming for selecting the optimum modality for controlling blood glucose in     diabetic surgical patient's receiving TPN. We will conduct a study to compare the efficacy of     once daily insulin glargine versus continuous regular insulin incorporated TPN in controlling     blood glucose in non-critically ill diabetic surgical patients receiving TPN.   "
81674|NCT02216916|"     Head and neck cancer is the sixth most common cancer and more than 650,000 new cases are     diagnosed each year worldwide. About 60% of the HNSCC patients present with unresectable     locally advanced disease at diagnosis and treated with multimodality approach. Despite such     approach, majority (70%) of patients develop local or/and regional recurrences. Additional     10% of patients present with distant metastasis at diagnosis. Most patients with recurrent or     metastatic disease are treated with single agent chemotherapy, combination chemotherapy or     targeted therapies.      Despite its public health magnitude, HNSCC in Asian countries has received a limited     attention for the drug development and cancer-related research. In fact, HNSCC ranked 7th     among men and 10th among women by incidence in China, the largest producer and consumer of     tobacco and alcohol. Recently, Chen et al. documented a 1:1:2 subset distribution for cancers     of oral cavity, pharynx, and larynx in China, similar to the distribution reported in Korea     but quite different from the general distribution of 5:2:3 in whites. Ethnic disparities in     HNSCC also include its prognosis and this is partly explained by HPV-active disease ratio and     genetic factors. Therefore, there is a strong need for an additional research in patients     with HNSCC in Asia.      Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to     poor prognosis in patients with HNSCC. The association between EGFR-activated signaling     pathways and tumor cell survival are well documented in many studies. EGFR targeting     strategies showed clinical anti-tumor efficacy in patients with HNSCC, especially with     monoclonal antibody, cetuximab. In the Extreme study, it was shown that the addition of     cetuximab to platinum-5-FU significantly prolonged the median overall survival from 7.4     months to 10.1 months compared to platinum-5FU alone in the first-line setting.      HM781-36B is a irreversible pan-HER inhibitor. In preclinical studies, HM781-36B has much     lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations and     produces tumor growth inhibition in gefitinib-resistant xenografts. A phase I trial of     HM781-36B in patients with advanced solid tumors showed clinically significant anti-tumor     activity and a phase II trials of HM781-36B in patients with non-small cell lung cancer and     advanced gastric cancer are currently ongoing.      We suggest a phase II trial of HM781-36B in patients with recurrent or metastatic HNSCC who     are resistant or ineligible/intolerant to platinum-based chemotherapy. The aim of current     trial is to evaluate the antitumor efficacy and safety profile of HM781-36B and to identify     biomarker to predict the tumor response to HM781-36B.   "
81675|NCT02216903|"     This is the evaluation which is associated with apnea symptom, one of the recurrence factors,     after AF ablation to patients who diagnosed AF.      This is the evaluation which is associated with excessive respiration exercise during AF     ablation to patients who diagnosed AF.      This is the evaluation which is associated with excessive respiration exercise to make a gap     during AF ablation to patients who diagnosed AF.   "
81676|NCT02216890|"     This study will examine the safety profile of SGN-CD70A. The study will test increasing doses     of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to     small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given     to patients without causing unacceptable side effects. The pharmacokinetics and antitumor     activity of SGN-CD70A will also be evaluated.   "
81677|NCT02216877|"     Randomized placebo-controlled interventional trial to investigate the effect of oral     magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease.     We hypothesize that oral magnesium supplementation will increase intracellular magnesium in     subjects with chronic kidney disease as well as increase serum magnesium.   "
81678|NCT02216864|"     The purpose of this study is to find out whether the use of multiple subcisions over several     visits will improve the appearance of rolling acne scars compared to no treatment.      This study was a pilot study designed to determine feasibility of this procedure.   "
81679|NCT02216851|"     The purpose of this study is to determine the safety and efficacy of using Restylane Perlane     to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group   "
81680|NCT02216838|"     The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat     facial flushing.      This study is a pilot study designed to determine feasibility of these procedures.   "
89800|NCT02110693|"     The purpose of the study is to develop and validate a questionnaire to screen and assess     adult primary care patients for tobacco, alcohol, prescription drug, and drug use and     problems related to their use.   "
81681|NCT02216825|"     Background: In recent years, probiotics have shown promise in treating a variety of diseases.     Previously, the investigators have reported on the clinical efficacy of bile salt hydrolase     active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in     hypercholesterolemic adults.      Objective: The purpose of the study is to investigate the effect of a delayed release or     standard vegetarian capsule containing L. reuteri NCIMB 30242, taken in escalated dose over a     4 week period, on the plasma bile acid profile.      Design: The study design is a pilot, randomized, double-blind, dose-escalation study. The     study will last a total of 6 weeks, including a 4-week intervention period and a 2-week     washout period.   "
81682|NCT02216812|"     The reported prevalence of disproportionate pain and disability among patients recovering     from a fracture of the distal radius varies widely. Literature reports numbers between 1% and     37%, perhaps in part because it is poorly defined, known by so many different names,     subjective, and unverifiable.      The investigators are interested in the effect of vitamin C after distal radius fractures on     objective measurement of finger motion, patient reported outcome measures, and pain     intensity, instead of the previously used, subjective and imprecise criteria for complex     regional pain syndrome.      Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius     fracture will be asked to participate in this clinical trial. Patient will be randomly     assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as     regarded by the treating physician at follow-up or for 6 weeks.      The investigators hypothesize no difference in finger stiffness at 6 weeks measured by     distance to palmar crease of the index through little finger between patients taking vitamin     C or placebo after a distal radius fracture. Additionally, the investigators assess finger     stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper     extremity function and pain score both measured at six months.   "
81684|NCT02216786|"     This is an open-label, multicentre, 4-arm randomised phase II trial of fulvestrant + AZD2014     versus fulvestrant + everolimus versus fulvestrant alone in patients with ER-positive,     HER2-negative advanced or metastatic breast cancer, whose disease relapsed during treatment     with (or within 12 months after discontinuation of) an AI in the adjuvant setting or     progressed during treatment with an AI in the metastatic setting. Patients will be randomised     (2:3:3:2) to one of the four treatment arms:        -  Fulvestrant        -  Fulvestrant + AZD2014 (continuous daily schedule)        -  Fulvestrant + AZD2014 (intermittent schedule - 2 days on, 5 days off)        -  Fulvestrant + everolimus      Randomization will be stratified by the following criteria:        -  Measurable disease (vs. non-measurable).        -  Sensitivity to prior endocrine therapy (sensitive versus resistant)   "
81685|NCT02216773|"     The aim of this study is to compare two different techniques (portal vein embolization and     radiofrequency assisted liver partition with portal vein ligation) for increasing liver     volume prior to major liver resection.   "
81686|NCT02216760|"     The heart beat is controlled by electrical signals. Following a heart attack, part of the     heart muscle dies and is later replaced by scar tissue. Within this area of scar, there often     remain channels of surviving tissue still able to transmit electrical signals. However, it     is well established that these conduction channels (CC) can form a short circuit around the     scar, leading to electrical disturbances (arrhythmias) that are potentially life threatening.     The commonest of these is ventricular tachycardia (VT), and is estimated to cause 300,000     deaths per year.      One recognised treatment option of VT involves burning (ablation) these conduction channels     (CC) within the scar. However, at present, the procedure is long and is far off 100%     effective. Consequently, current best practice does not rely on treating the VT, but rather     preventing it from causing sudden death - this is achieved with an Implantable Cardioverter     Defibrillator (ICD), a device which can recognise when a patient is in VT and deliver an     internal shock to restore the normal electrical conduction. Patients with defibrillators     subsequently are subject to recurrent painful and debilitating shocks which, although     lifesaving, significantly reduce their quality of life. The limitation with ablation at     present is due to the difficulty in visualising these CC's.      Investigators at Imperial College have created a novel electrogram visualisation program,     Ripple Mapping (RM), which they have already found to be superior to currently used     programmes in cases of arrhythmias in the upper chambers of the heart (the atria). During a     retrospective study in patients with scar related VT following a heart attack, when ablation     was delivered in areas associated with identified Ripple Mapping Conduction Channels, these     patients remained free of VT recurrence for >2 year follow up interval.      The study hypothesis is that Ripple Mapping can identify all conduction channels within scar     tissue critical to the VT circuit, ablation of which will lead to long-term freedom from VT     and ICD therapies. The investigators now aim to perform a prospective randomised study     comparing Ripple Mapping guided VT ablation against conventional VT ablation.   "
81687|NCT02216747|"     Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood.     conventional treatment is steroid treatment and nearly 90% response to this treatment well.      Response to this treatment is the most important prognostic factor and this patients has a     benign disease course.      60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated     steroids courses can lead to serious adverse events in children such as low bone     density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side     effect corelation between steroid dose and treatment duration.      guidelines for steroid dose for NS relapse are not based on retrospective clinical research     but only on Nephrologists and experts opinion.      Rational- What would be the optimal low dose steroids and the shortest time of treatment in     Nephrotic syndrome relapse?   "
81821|NCT02215005|"     The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and     80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril.     Therefore the relative bioavailability of telmisartan and ramipril given in combination was     determined in comparison with either telmisartan or ramipril given alone.   "
81688|NCT02216734|"     The investigators hypothesize that a strategy of establishing facility-based mother support     groups (MSGs) for HIV-positive mothers will result in increased retention rates of     HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery     compared to clinics that lack MSGs. The study will be conducted in health facilities in rural     Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster     controlled study design will be used in 30 rural clinics randomly assigned to either arm to     compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm     2 consists of standard of care together with facility-based MSGs.   "
81689|NCT02216721|"     Primary aldosteronism (PA) is a disorder of the adrenal gland causing an autonomous     overproduction of mineralocorticoids, leading to arterial hypertension. Although rare, it is     the most frequent cause of secondary hypertension. Early detection is important to avoid end     organ damage, specifically cardiovascular and metabolic morbidity. Recent studies showed a     positive correlation between patients with PA with lower bone density especially at the     spine, with significant improvement post treatment, either medically or surgically. There was     also a positive correlation between high aldosterone renin ratio with higher levels of intact     parathyroid hormone (iPTH) which is responsible for cortical bone loss especially at the     distal forearm.      We hypothesize that our patients with PA have a higher level of iPTH, with lower bone density     especially at the distal forearm, with improvement post treatment.   "
81690|NCT02216708|"     The recommendation for correction of dehydration of severely malnourished children with     diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example,     in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart     failure. There is not enough evidence to convince some of the physicians dealing with     severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid     rehydration per se is associated with increased incidence of over hydration and heart     failure. And whether this approach is applicable in the management of severely malnourished     children with severe cholera, which usually require rapid correction of water and electrolyte     deficits for prevention of deaths due to hypovolaemic shock and other complications, has not     been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration     (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing     appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help     in improving the renal function, acidosis and thus improve appetite and reduce ORS failure     subsequently. Since our study was uncontrolled, so we have planned a randomised controlled     study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12     hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid     over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for     length <-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery     of <24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked     to participate in this study. After the parents'/Legal guardian's consent, the children will     be transferred to the study ward and will be treated according to the protocol. All children     will receive similar treatment except the mode of rehydration, different for the two groups.     The children will be closely monitored throughout the study period. The primary outcomes     incidence of over hydration and ORS failure and secondary outcomes improvement of renal     function and improvement of appetite measured by the food intake will be compared between the     groups.   "
81691|NCT02216695|"     The true population incidence of acute kidney injury (AKI), previously called acute renal     failure, in England is not known. A better understanding of the epidemiology of AKI at a     national level is essential to inform initiatives to prevent AKI as well as reduce the     associated morbidity and mortality. The purpose of this study is to combine the national     database of all hospital discharges with national census data to investigate trends in the     incidence of both, AKI not requiring dialysis and AKI requiring dialysis, as well as its     associated mortality and its determinants in England between 1998 and 2013   "
81692|NCT02216682|"     To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and     consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement     with spinal anesthesia.      Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid     consumption, a lower percentage of patients rescuing, or a longer time to first rescue with     IV acetaminophen. The investigators will compare the efficacies of oral and intravenous     acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.   "
81709|NCT02216461|"     To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated     dosing   "
81693|NCT02216669|"     This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an     oral dual drug with two mechanisms of action:        1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the          sulfamide components        2. radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety      The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design     first as single agent then combined with radiotherapy:        1. A single agent dose-escalation phase in patients with solid tumours.        2. A dose-escalation phase in patients with HNSCC in combination with radiotherapy      The main objective is to determine the recommended phase II dose of DTP348 in combination     with radiotherapy   "
81694|NCT02216656|"     This randomized, placebo-controlled, double-blind (included open arm of KRN1493     (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety     in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for     three weeks for secondary hyperparathyroidism patients receiving hemodialysis.   "
81695|NCT02216643|"     Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a     sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with     stentriever and/or Thromboaspiration versus medical management alone. Randomization will be     done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion     site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to     medical management alone in achieving more favorable outcomes in the distribution of the     modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel     ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase     or have received IV alteplase therapy without recanalization. Sample size is projected to be     690 patients for a difference in treatment effect of 10%.   "
81696|NCT02216630|"     This will be an open-label, non-randomized multi-center study designed to assess the safety     and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of     cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect     the adipose tissue specimen for subsequent processing to isolate the stem cells.   "
81766|NCT02215720|"     Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal     cancer or head and neck cancer in several phase II/III studies.      Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II     studies in advance kidney cancer of bad prognosis.      Study hypothesis is that combination of those two compounds and the inhibition of two     pathways at the same time will have more efficiency on tumoral growth than the inhibition of     those pathways in isolation.   "
81697|NCT02216617|"     The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib     administrated in combination with docetaxel (Taxotere®) and cisplatin in induction     chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,     allowing the comparison with standard induction chemotherapy TPF.      It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20,     30 and 40 Mg per day) will be studied in combination with the fixed standard doses of     docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of     afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment     each one (9 weeks on the whole). The next dose level will be studied only if the previous     dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st     cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients     will be treated with this dose. A maximum of 22 patients should be included in this study.     The total duration of the study is estimated at 18 months. In case of major safety problems,     the study may be stopped earlier. In short, the preclinical data, pharmacological and     clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and     that the association of afatinib with cisplatin and docetaxel could be effective in patients     with head and neck squamous cell carcinoma potentially resulting in an extension of time to     progression.   "
81698|NCT02216604|"     Today about 80% childhood cancer patients become long-time survivors. In spite of the high     cure rates the diagnosis cancer is associated with a variety of disease and treatment-related     psychological and physical impairments mostly present into adulthood. So the attention has to     focus on the improvement of these problems such as motor limitation, dysfunction of the     cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished     quality of life (Qol). Although exercisel intervention studies in this field are generally     scarce, the results of these studies are promising. Up to now studies during the acute phase     of treatment are missing almost completely. The aim of this feasibility study is to evaluate     the potential benefits of a modular exercise intervention program for childhood cancer     patients startunf in parallel with treatment and longlasting for one year. Across two years     cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21     years, free of any contraindications for physical activity will be recruited. All     participants are asked to complete a physical assessment battery (strength, endurance and     balance capacity, posture control, functional mobility, range of motion) and additionally two     questionnaires concerning Qol and motivation, at baseline and every three months following     one year   "
81699|NCT02216591|"     The proposed study will test the efficacy of a cognitive training program to improve working     memory in a sample of HIV-infected persons. Investigators will assign 40 HIV-infected adults     with poor medication adherence to one of two conditions (20/group): the experimental     cognitive training intervention or a control training condition. Participants will complete     12 training sessions across 10 weeks and will complete assessments at baseline and     post-training. The specific aims are to:        1. Investigate the effects of the cognitive training intervention on working memory and          delay discounting in HIV-infected persons.           Hypothesis 1: Participants assigned to active cognitive training, compared to those in          the attention-matched control group, will have greater improvements in working memory          and reductions in delay discounting.        2. Characterize adherence to antiretroviral medications in this population and examine          medication adherence after cognitive training.      Hypothesis 2: Participants assigned to active cognitive training, compared to those in the     attention-matched control group, will have greater improvements in medication adherence.   "
90327|NCT02103751|"     The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially     Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in     smokers and non smokers.   "
81700|NCT02216578|"     The study is a multi-center, multi-national, open label, single arm Phase II study of     single-agent cabozantinib. The objective of the study is to assess the safety and activity of     cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and     sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase     inhibitors.      Patient will receive cabozantinib until they experience no further benefit from the     treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment     beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon     investigator's discretion, provided no other criteria for treatment withdrawal are met.   "
81701|NCT02216565|"     This trial aims at comparing two strategies currently used to address acute ischemic stroke     of the middle cerebral artery : medical treatment without endovascular treatment on the one     hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of     the strategies will be assessed in terms of early neurological clinical recovery.      The study will focus on three particular situations : (1) tandem internal carotid and middle     cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis     because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended     because of a delay superior to 4.5 hours.      The hypothesis to be tested is that medical approach plus endovascular treatment is superior     to medical treatment alone   "
81702|NCT02216552|"     The current project is designed as a 30-day pilot trial to demonstrate the safety and     tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and     improve insulin sensitivity to prevent type 2 diabetes.   "
81703|NCT02216539|"     Patients benefitting from a lung transplantation are subject to long-lasting and often severe     post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.      The study hypothesis is that pre-operative training in self-hypnosis given to patients     awaiting lung transplantation, will result in a reduction of post-operative pain one month     after surgery.   "
81719|NCT02216331|"     This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will     examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects     will receive a single 400-mg dose of TMC207 administered alone on Study Day 1. Period 2 will     examine the effects of repeated doses of either rifapentine or rifampicin on TMC207     pharmacokinetics and will begin on Study Day 20. During Period 2, subjects will receive 22     daily doses of either 600 mg rifapentine or rifampicin from Study Day 20 through Study Day     41. A single 400-mg dose of TMC207 will be administered on Study Day 29. Subjects will be     confined to the clinic from Study Day-1 to Study Day 2 in the morning of Period 1, and Study     Day 19 to Study Day 30 in the morning of Period 2. The study hypothesis is to determine     whether Rifapentine affects the pharmacokinetics of TMC207 as measured by effects on Cmax and     AUC(0-t) to a lesser degree than rifampicin.   "
81704|NCT02216526|"     Residents of institutional long-term care facilities are at high risk for developing skin and     tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis,     candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant     melanoma) but there are few epidemiological figures about the actual frequencies of these     conditions in nursing homes. Therefore, in the first part of this study we aim at measuring     key dermatological conditions and associated health and functional status, and the skin care     practice of aged nursing home residents (prevalence study).      Basic skin care interventions are believed to reduce skin dryness and to enhance skin health.     Thus, the second aim of this study is to investigate the effectiveness of two structured skin     care regimens compared to the routine standard skin care on skin health in nursing home     residents (intervention study).      The study will be conducted in a random sample of seven out of approximately 300     institutional long term care facilities of the federal state of Berlin.   "
81705|NCT02216513|"     The investigators will test the central hypothesis that DFO treatment after SAH may improve     cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective     neuroprotectant against delayed ischemic injury after SAH.   "
81706|NCT02216500|"     Approximately a fourth of children with seizures do not respond adequately to available     therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but     there is no agreement concerning how it works and what is the best way to administer it. This     natural history study will collect data pertaining to both questions.   "
81707|NCT02216487|"     As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing     chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for     delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of     hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in     optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific     example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced     efficacy in both nonclinical and early clinical studies.      The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm     trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild     type metastatic colorectal cancer. The study objectives are to confirm the safety and     efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic     colorectal cancer patients.      It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent     treatment and follow up; thus the trial will run for approximately 2-3 years.   "
81708|NCT02216474|"     Brain stimulation in movement disorders      This trial will explore the effects of very gentle electrical stimulation of the brain in     patients with movement disorders. Other studies have already been carried out and have shown     that brain stimulation may help to improve mental abilities and the symptoms of conditions     such as depression and stroke. The investigators will show whether this method can help with     symptoms such as memory and concentration problems in patients with movement disorder who     have mild to moderate problems with these mental abilities. The investigators will also look     at the effects of brain stimulation on movement symptoms and mood. These people will be     compared to healthy people to help us understand whether brain stimulation works differently     in healthy people and people with brain disorders.      This trial is being carried out at one centre in Birmingham. It is scheduled to begin in     September 2014 and will last for up to five years. As the study commences it is being funded     by Birmingham and Solihull Mental Health Foundation Trust and University of Birmingham. The     investigators plan to recruit up to a maximum of 200 individuals in this study.   "
81710|NCT02216448|"     The purpose of this study is to compare between two groups of residents with basic     arthroscopic skills in diagnostic knee arthroscopy. The first group will train on a knee     arthroscopic simulator in a lab, and the second group will perform diagnostic knee     arthroscopy in the operating room. Both groups will be assessed by senior arthroscopy surgeon     in the operating room based on selected competencies following the Global Rating System.   "
81711|NCT02216435|"     Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,     slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain     Stimulation (DBS) is the FDA-approved method for patients who no longer get effective     treatment from the best available medication. The location in the brain where the electrode     is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study aims     to investigate another location in the brain, the Substantia nigra pars reticulata or SNr.     The SNr is also known to be involved in motor control of muscles and may be involved in the     process by which the initiation of movement occurs.   "
81712|NCT02216422|"     This was a multicenter study evaluating the efficacy and safety of     ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12     weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV     treatment-experienced, cirrhotic HCV genotype 1b-infected adults.   "
81713|NCT02216409|"     The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in     participants with solid tumors.   "
81714|NCT02216396|"     One third of the population, aged over 65, live and will die with dementia. Half of people     with dementia experience symptoms of agitation every month. Symptoms of agitation include     restlessness, pacing, shouting and verbal or physical aggression. Many people with agitation     are admitted to care homes as families find they cannot care for them at home. Within the     care home, staff also often find managing people with agitation difficult and they react in a     wide range of ways. Agitated behaviour takes up staff time and emotional and physical energy     but they do not always know how to respond. This study is one of the streams in an integrated     programme to help tackle agitation in a variety of settings from domestic environments to end     of life.      Our primary hypothesis is that for people with dementia living in care homes, paid carer use     of dysfunctional coping strategies predicts lower quality of life in residents with dementia     and that this is more so at higher levels of agitation.      We will recruit 60-80 care homes (residential or nursing homes). We will identify all     residents with dementia, and the care home manager will approach them and their family     carers. After obtaining informed consent, or advice from personal or nominated consultees for     those lacking capacity, we will ask people with dementia who can answer questions about their     quality of life using the DEMQOL. We will also ask staff and their family carers for those     who have them, to rate the quality of life of the person with dementia using the DEMQOLproxy.     We will ask care home staff other questions about residents with dementia, including about     agitation, using the Cohen-Mansfield Agitation Inventory (CMAI), and the care they receive.     Staff will also answer questions about the ways they cope with caring stresses, using the     COPE. We will measure quality of life and agitation 5 times over 16 months. We will use our     results to test our theory that agitation is an important factor determining residents     quality of life, and that the ways staff cope with stress affect the impact agitation has on     quality of life.   "
81715|NCT02216383|"     BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due to     excessive bleeding after the birth of the baby and placenta, or post-partum haemorrhage     (PPH). In the UK, PPH affects approximately 10% of new mothers. PPH can be extremely     frightening for women and can cause them to need additional treatments including blood     transfusion and removal of the womb as well as prolonging their hospital stay.      The most common cause of PPH is an inadequately contracted womb after childbirth. Giving the     mother an injection of uterotonic medicine following the birth of their baby can prevent     this. It reduces the risk of PPH by 66% and this should routinely be offered to all labouring     women.      In the UK, the two medicines most commonly used for this purpose are Syntocinon and     Syntometrine. Both mimic natural hormones. Syntometrine is longer acting, but a published     review of trials comparing these two medicines concluded that Syntometrine is no better at     preventing severe blood loss. Syntometrine is associated with more side effects including     nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of     stroke. All guidelines therefore recommend Syntocinon for preventing PPH.      Our group conducted a telephone survey of all maternity units in the UK, and found that 71.4%     of units still routinely use Syntometrine. Investigators estimate that 40,000-70,000 women     per year are experiencing distressing nausea and vomiting in the emotionally important first     few hours following childbirth. These women are also receiving a medicine with the potential     to cause dangerous high blood pressure.      Carbetocin is a newer medicine, already widely used after caesarean section, but not yet     after vaginal birth. Other studies have shown that Carbetocin is slightly better at     preventing bleeding after birth when compared to Syntometrine, that it has fewer side effects     than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No     studies have directly compared all three medicines or compared their overall cost;     information vital to the NHS.      METHOD Investigators propose a trial of 6285 women over 13 months, in four maternity units in     the South-West to compare the effectiveness, side effects and cost of Syntocinon,     Syntometrine and Carbetocin, for women having a vaginal birth.      Women will be randomly allocated to receive one of these drugs. Women and staff will not know     which drug they receive, so as not to influence the results collected. Staff will collect     data such as the number of extra drugs and treatments needed and the volume of blood lost.     Women will be asked to complete a side effects questionnaire. Investigators will perform an     analysis of cost effectiveness once all results are available.      AIMS Investigators aim to establish whether Carbetocin is an effective and affordable     alternative to Syntocinon and Syntometrine, and whether it has fewer side effects for new     mothers. Publication of our results, regardless of what they find, could potentially improve     the birth experience of women across the UK, and support the health service in spending its     money most effectively.   "
81722|NCT02216292|"     Human milk is the best source of enteral nutrition for the preterm infant. However during the     infants first hours and days of life breastmilk from the own mother is usually not available.     Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical     University Vienna was to start with formula feedings within the first 6 hours of life of a     premature infant and switch over to breastmilk as soon it was available. In June 2012 the     investigators changed this feeding regimen and started to use single donor milk of mothers of     preterm infants for the first hours and days of the preterm infants life. In a prospective     observational study the investigators evaluated the impact of single donor milk from preterm     infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in     preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data     will be compared with a historical control group starting with preterm formula as source of     enteral nutrition. The investigators hypothesize that starting enteral nutrition with single     donor milk of mothers from preterm infants with shorten time to full enteral feedings.   "
81723|NCT02216279|"     Pulmonary hypertension or elevation of the pressure in the pulmonary vessels, results from     various clinical conditions. It may be idiopathic (of unknown cause) or associated with     numerous diseases including cardiovascular and lung disorders. Affected individuals suffer     from progressive shortness of breath and, in its most sever forms; pulmonary hypertension     carries a worse prognosis than many types of cancer. There is no test currently that can     easily and non-invasively detect abnormalities of the pulmonary circulation. Presently there     is no cure for pulmonary hypertension and substantial research efforts are dedicated to the     development of new drugs that will stop progression or better yet, reverse the disease     process. The investigators do not know if any of the drugs currently commercialized for     pulmonary hypertension directly improve the status of the pulmonary vessels since no test     currently provides this information. Direct earlier detection of lung vessel abnormalities     associated with pulmonary hypertension using a sensitive and non-invasive test would allow     not only earlier testing of these and of new drugs, but would provide a much better surrogate     of disease severity allowing more efficient pre-clinical drug testing. The aim of this phase     II study is to evaluate the safety of PulmoBind in participants with pulmonary hypertension     and its potential to detect abnormal pulmonary circulation associated within pulmonary     hypertension.   "
81724|NCT02216266|"     Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in     Intensive care after a surgery   "
81725|NCT02216253|"     This study will include women who will undergo pelvic reconstructive surgery and/or     anti-incontinence sling procedures. Patients will be randomized to the combination of     L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day     during the seven days before and after surgery (total of 14 days). In this randomized,     double-blind study, the investigators will assess treatment of clinically suspected or     culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk     factors for treatment for postoperative urinary tract infections (secondary outcomes) between     the two study groups.   "
81744|NCT02216006|"     Atelectasis is common during and after general anesthesia. Atelectasis develops early if     preoxygenation with 100% oxygen is used and continuously used during induction until     endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation     maneuver immediately after confirming a successful intubation, reduces the area of     atelectasis as investigated by computed tomography compared to a standard procedure.   "
81745|NCT02215993|"     Introduction:      Platelet aggregation plays an important role in ischemic complications in patients undergoing     to percutaneous coronary intervention (PCI). The addition of clopidogrel, as a second     antiplatelet agent, to acetylsalicylic acid (ASA) was effective in reducing major     cardiovascular events in patients with acute coronary syndrome (ACS).      However, approximately 30% of ACS patients are resistant to clopidogrel, representing a     population of medically vulnerable and high risk for major cardiovascular events, including     myocardial infarction (MI), stent thrombosis and death.      In the randomized trial TRITON, prasugrel compared to clopidogrel was more effective in     significantly reducing the rates of MI (7.4% vs. 9.4%) and stent thrombosis (2.4% vs .1,1%)     in patients with ACS, however, patients treated with prasugrel showed higher rates of     bleeding (2.4 vs. 1.8%) and no difference in mortality. Upon analysis of subgroups is not     recommended its use in patients with a history of stroke in those older than 75 years and     weighing less than 60 kg.      The latest class of inhibitors of the P2Y12 receptor is the cyclopentyl-triazolopyrimidines     represented by ticagrelor. Unlike the thienopyridines, ticagrelor interacts with the platelet     receptors in a reversible way and has a beginning and peak of action faster.      The efficacy and safety of ticagrelor were evaluated in the study PLATO, where 18.624     patients with ACS were randomized to receive clopidogrel (75mg/day, with a loading dose of     300 to 600mg) or ticagrelor (90mg 2x/day with a loading dose of 180mg) The primary combined     endpoint (mortality from vascular causes, MI or stroke) at 12 months was significantly lower     in the ticagrelor (9.8% vs. 11.7%). There was no significant difference in the rates of major     bleeding in both groups. Moreover, the isolated analysis of the rates of MI, vascular     mortality and mortality from all causes showed statistically significant reduction in the     ticagrelor users. In this study, the main adverse effects were dyspnea and bradycardia.      The assessment of platelet reactivity may allow the individualization of antiplatelet     therapy. However, simply increasing the dose of clopidogrel in patients who persisted with     high platelet reactivity was not able to reduce the combined endpoint of cardiovascular     death, nonfatal myocardial infarction and stent thrombosis in six months.      In a population of patients with stable coronary artery disease, the substitution of     clopidogrel for ticagrelor showed a rapid and persistent decrease in platelet aggregation     measured by different laboratory methods. However, in patients with ACS subjected to PCI, the     assessment of platelet aggregation after the replacement of clopidogrel for prasugrel or     ticagrelor still requires evidence.      Objectives:      To evaluate the platelet response to ticagrelor and prasugrel in ACS patients with ST-segment     elevation submitted to thrombolysis.      To evaluate security in follow up of 30 days.      Methods:      The study will be a prospective, randomized, single-center (São Paulo Hospital - Federal     University of São Paulo), single-blind. The investigators will select 50 patients admitted     with ACS with ST-segment elevation submitted to thrombolysis and who underwent cardiac     catheterization between 3 to 24 hours in the case of reperfusion or immediately for rescue     angioplasty. Blood sample for analysis of platelet aggregation through the system VerifyNow     ®, shall be obtained immediately after the procedure on patients on clopidogrel for at least     seven days in maintenance dose of 75mg or after 8 to 6 hours after the dose of 300mg and     600mg respectively. Patients will be randomized in a 1:1 ratio to receive ticagrelor the dose     of 180mg and maintained dose of 90 mg twice a day for thirty days or prasugrel dose of 60mg     and maintained for thirty days at a daily dose of 10mg. A new blood sample and analysis of     platelet aggregation will be repeated after 2, 6 and 24 hours. The demographic and clinical     data of this population will be collected in specific form and stored in databases for later     analysis   "
82051|NCT02211976|"     Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl     and simeticone compared with the efficacy and tolerability of the single products in patients     suffering from constipation and bloatedness   "
81726|NCT02216240|"     Supraventricular tachycardia (SVT) is a term describing any rhythm coming from the top half     of the heart. Although atrial fibrillation is the commonest cardiac arrhythmia, regular SVT's     are also common. The two commonest regular SVT's are atrioventricular (nodal) reentry     tachycardias (AV(N)RT) and atrial flutter (AFL). Atrioventricular (nodal) reentry     tachycardias (AV(N)RT) are common but benign forms of fast heart rhythm. Although AV(N)RT can     cause unpleasant symptoms and are frightening it is not dangerous. If patients present with     AV(N)RT the accepted and normal treatment for most is to have the fast heart rhythm stopped     by either taking a deep breath and straining or by the use of drugs. Patients can then be     discharged home and have further investigation and treatment as an outpatient. SVT can be     frightening for the patient but is easy to diagnose and treat. There is high success rate     post treatment for this benign condition. This is traditionally done in the local accident     and emergency, although patients can sometimes be unnecessarily admitted to hospital     overnight. We propose to investigate the safety and efficacy of training paramedics to treat     safe forms of AV(N)RT at the scene and then giving the patient an information pack which     includes a request for a GP referral to a heart rhythm specialist. Patients will be randomly     allocated after consenting to take part in the study to either get paramedic or accident and     emergency department treatment. We will compare these two approaches by telephone follow up     of the patients. The costs of the different approaches will be compared by assessing the rate     of appropriate investigation and the information given to patients and how they rated their     experiences.   "
81727|NCT02216227|"     The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the     checklist to prevent MRSA SSIs among veterans undergoing TJA or cardiac surgery, and 2) to     assess barriers and facilitators to checklist implementation.      Hypotheses:        1. The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty          and cardiac surgery patients.        2. Implementation of the checklist will be associated with an overall reduction in SSIs          caused by all pathogens.        3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs.        4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI          checklist.   "
81729|NCT02216201|"     The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical     device for the the determination of sweat gland function in the pediatric population.      Primary Objective: To measure sweat gland function in a pediatric population      Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland     function in the pediatric population   "
81730|NCT02216188|"     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A     vaccinations in patients with Parkinson's disease. Patients, who have already participated in     AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One     study site in Vienna (Austria) will be involved.      In addition, up to 8 patients will be offered participation within an untreated control     group.   "
81822|NCT02214992|"     Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose     combination versus its monocomponents given concurrently   "
81731|NCT02216175|"     Allergy to cow's milk is the most common food allergy affecting children. There is currently     no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to     induce desensitisation using small daily doses of cow's milk, predominantly by the oral route     (oral immunotherapy, OIT). Although this therapy works for some people, its effects are not     generally long lasting and it is associated with significant side effects during protocol,     including potentially life-threatening allergic reactions.      Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the     tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer     adverse events. However, the degree of desensitisation induced appears to be lower than that     with oral immunotherapy.      The investigators wish to determine whether a sublingual pretreatment phase can improve the     safety of conventional OIT in cow's milk allergy.   "
81732|NCT02216162|"     PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric     intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.      Patients in the intervention group will be proposed:        -  A regular geriatric follow up including an attentive screening of joint symptoms and          functionality,        -  An adapted treatment of join pain,        -  Weekly sessions of adapted physical activity (Taï Chi),        -  And a systematic correction of vitamin D deficits.   "
81733|NCT02216149|"     Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are     occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is     infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less     frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head     comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical     coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow     response to a cold pressor test, in a patient population who are being treated for     adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens,     either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.   "
81734|NCT02216136|"     This is an observational study of 3 arms: breast conservation therapy (Group A), mastectomy     and reconstruction (Group B), and mastectomy only (Group C).   "
81746|NCT02215980|"     This protocol is a phase III multicenter, randomized, controlled study designed to assess the     safety and the efficacy of standard schedule versus a new algoritm of dose reductions in     elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus     steroids.   "
81759|NCT02215811|"     This is a multi-center, open-label, non-randomized controlled trial. Patients with     viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane     oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic     bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as     preoperative clinical characteristics and postoperative clinical outcomes will be registered.     Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and     postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be     performed postoperatively. All available data will be collected prospectively. Follow-up is     12 months. Informed consent will be obtained from relatives to patients meeting the inclusion     criteria before the initiation of any study-specific procedures.   "
81735|NCT02216123|"     This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total of     300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female     subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD)     deficiency (>=40% - <70% of the site median G6PD value). Subjects must have a blood smear     that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive     tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects     will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1     or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will     receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is     180 days, including screening and randomization to treatment (Day 1), three in-hospital days     (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11     and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180).      The primary safety data collected in this study will help to understand the hemolysis risk to     both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study will     support the results for sister study TAF112582, the pivotal phase III efficacy and safety     study of the TQ program.   "
81736|NCT02216110|"     Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic     submucosal dissection (ESD) has been accepted as standard treatment in selected patients with     negligible risk of lymph node metastasis. However, there are limited data regarding the     long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall     survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.   "
81737|NCT02216097|"     The purpose of the study is to evaluate proof of mechanism of PF-04457845, using a     well-established neuroimaging paradigm including behavioral tasks selected to activate     neuro-circuitry relevant to Post Traumatic Stress Disorder. It is hypothesized that     PF-04457845 will modulate the Blood-oxygen-level dependent Functional Magnetic Resonance     Imaging signal from the relevant neuro-circuits in patients with Post Traumatic Stress     Disorder.   "
81738|NCT02216084|"     The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter,     dose-escalation study is to evaluate the safety, including immunogenicity, and     pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with     severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity <6%)     who are assigned to one of three dose cohorts.   "
81739|NCT02216071|"     The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL     CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic     Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when     administered twice daily for 7 days.   "
81740|NCT02216058|"     A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA     CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.   "
81741|NCT02216045|"     Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this     study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon     Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .   "
81767|NCT02215707|"     This is an open-label evaluation of the safety, tolerability immunogenicity and efficacy of     the PfSPZ Vaccine administered by Direct Venous Inoculation (DVI) in healthy, malaria-naïve     subjects. There will be 3 groups and a total of 69 subjects (45 immunized subjects and 24     infectivity controls).   "
81768|NCT02215694|"     The purpose of this study is to evaluate the effect of dual probiotic strains containing     Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and     apolipoprotein A-V.   "
81823|NCT02214979|"     Study to demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2.5 mg ramipril fixed-dose     combination (FDC) versus its monocomponents given concomitantly   "
81824|NCT02214966|"     The objective was to investigate the relative bioavailability of the fixed dose combination     (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the     bioavailability of the FDC tablet while fasting.   "
81742|NCT02216032|"     Thirty Million Words Home Visiting: A Longitudinal RCT is a longitudinal, randomized control     trial, which is required to confirm whether the parent behavior changes seen during the     feasibility trial are sustainable, and, critically, whether those changes translate into     positive impacts on child language outcomes, child social-emotional development, and     subsequent school readiness. The investigators will deliver the Thirty Million Words (TMW)     Curriculum to 100 Treatment families, and the investigators will be following the children     through kindergarten in order to measure the effects and sustainability of the curriculum.     The investigators will deliver a Nutrition Curriculum to 100 Control families in order to     control for the possible attentional effects experienced by those in the Treatment group.     Moreover, as an ethical consideration, the investigators wish to also provide families in the     Control condition with valuable education that may enhance their children's development.      The investigators hypothesize that the primary effects of the TMW Intervention will     significantly 1) improve low-SES parents' understanding of the importance of parent language     in a child's development, 2) increase parents' linguistic interaction, responsiveness, and     overall engagement with their children, and 3) increase children's language output.     Furthermore, the investigators hypothesize that increased parental interaction will result in     4) an improvement in children's social-emotional development. Finally, the investigators     hypothesize that these social-emotional and linguistic gains through early development, along     with sustained increased parental engagement, will be expressed in 5) increased child school     readiness upon kindergarten entry.   "
81743|NCT02216019|"     In septic patients, Septiflux1 study identified immature granulocytes which may have a     diagnostic and prognostic interest. However, with these preliminary results it is not     possible to make a difference between what is linked to the infection and what is a     consequence of the inflammation which goes along with the septic process. Using flow     cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary     bypass in heart surgery could make possible to test the diagnostic interest of the immature     granulocytes but also to attribute a prognostic value for the occurrence of post-operative     infections.   "
82052|NCT02211963|"     Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI     44847 following administration of multiple rising oral doses over 8 days in patients with     type 2 diabetes.   "
81747|NCT02215967|"     Background:      - T cells are white blood cells that fight several cancers. One cancer therapy involves     removing a person s T cells, changing them in a lab, and then returning them to the person.     Researchers want to see if this helps people with multiple myeloma.      Objective:      - To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with multiple     myeloma.      Eligibility:      - Adults ages 18 70 with multiple myeloma that has not responded to standard therapies.      Design:        -  Participants may be screened with:        -  Medical history        -  Physical exam        -  Blood and urine tests        -  Heart tests        -  Bone marrow sample        -  Multiple scans and X-rays        -  Participants will have apheresis. Blood is removed through a needle in an arm. T cells          are removed. The rest of the blood is returned through a needle in the other arm.        -  The cells will be changed in a laboratory.        -  Participants will get 2 chemotherapy drugs over 3 days.        -  Two days later, participants will check into the hospital. They will get an intravenous          (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1          infusion.        -  After this, participants will stay in the hospital for at least 9 days and stay nearby          for 2 weeks. Then they will have blood tests and see a doctor.        -  Participants will visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion, then          every 6 months. A bone marrow sample will be taken at the 2-month visit.        -  Participants blood will be collected for several years. Participants will have an annual          physical at NIH for 5 years after the infusion. Then for 10 years they will answer          health questionnaires.   "
81748|NCT02215954|"     To demonstrate non inferiority of a) FE 999169 Split Dosing Schedule (one dose on the day     before and the second dose on the day of colonoscopy) and b) FE 999169 Day Before Dosing     Schedule (two doses on the day before colonoscopy) to  Niflec On the Day Dosing Schedule     in subjects requiring colonoscopy.   "
81749|NCT02215941|"     The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in     plasma following single and multiple-dose topical application of 8% TV-45070 ointment.   "
81750|NCT02215928|"     This research trial studies using genomic profiling to recommend anticancer treatment to     patients with cancer that has spread beyond the original site of the tumor (metastatic     cancer). Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect     genetic changes or abnormalities. This information can then be used to recommend treatments     that may be more likely to result in a beneficial response. It is not yet known whether     genomic profiling will detect abnormalities that can be used to make treatment     recommendations and whether treatment based on genomic profiling is more effective than     standard treatment.   "
81751|NCT02215915|"     A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI)     with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly     randomized 1:1 to either IVUS guidance or angiographic guidance groups.   "
81752|NCT02215902|"     Primary Objectives:      To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood     purification.      Secondary Objectives:      To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the first     and last Hemopurifier treatments using elution methods developed by Aethlon Medical Inc.      To measure changes in viral load in patients before and after treatment with the Aethlon     Hemopurifier®.   "
81825|NCT02214953|"     To compare the oral bioavailability and rate of absorption of four prototype extended-release     (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy     male volunteers.   "
81755|NCT02215863|"     Recent reviews have highlighted the unpredictability and complexity of immune interference     when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has     become evident that the likelihood of immune interference (in response to conjugated- or     co-administered antigens) increases in proportional to the number of glyco-conjugates     (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins:     tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex     outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus     influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity,     but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell     dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but     apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13     co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat     reduced compared to the results with PCV13 alone.      Similar to children, adults frequently visit outpatient clinics to get two or more kinds of     vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and     tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine,     etc. PCV13 has limited co-administration information for adjuvanted influenza vaccine.      This study is designed to evaluate the immunogenicity and safety of PCV13 and MF59-adjuvanted     influenza vaccine (Fluad) after concomitant administration in adults aged 60 years or older.   "
81756|NCT02215850|"     SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in     development for the treatment of solid tumours over-expressing CA IX. CAIX, a transmembrane     metalloenzyme, is overexpressed on extracellular surfaces of hypoxic tumour cells but its     expression is highly restricted in normal tissue. CAIX is a functional regulator of processes     critical for tumour growth and metastasis, including pH regulation, survival, migration and     invasion.      This prospective single arm study will evaluate the safety of SLC-0111 given once daily in 28     day cycles in subjects with advanced solid tumours. The intent of this research study is to     find our more information such as: the highest dose of SLC-0111 that can be given safely, the     side effect it may cause, to examine how the body affects the study drug concentration in the     blood (pharmacokinetics or PK), and to gain some information on its effectiveness in treating     cancer.   "
81757|NCT02215837|"     The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined     with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK)     for gastric cancer.   "
81758|NCT02215824|"     The primary aim of this trial was to investigate the safety of a 6 hour intraarterial     infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive     disease (PAOD) and chronic Critical Limb Ischaemia (Fontaine class III or IV).   "
81760|NCT02215798|"     Primary objective: To estimate the frequency of adverse events, serious and non-serious in     Filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg once     daily within the study duration of approximately 6-8 weeks in a naturalistic clinical     setting. Secondary objective: To evaluate the change from baseline to endpoint in the Brief     Pain Inventory (BPI) and Neuropathic Pain Questionnaire (NPQ) assessed by the investigators     in duloxetine use in the treatment of diabetic peripheral neuropathic pain among Filipino     patients within the study duration of approximately 6-8 weeks in a naturalistic clinical     setting.   "
81761|NCT02215785|"     Constipation is a symptom suffered by a large number of people, due to multifactorial causes.     Some studies have proven that modifying lifestyle reduces the risk of constipation, with     high-fibre diets being less prone to constipation. Kiwifruit consumption, improves functional     constipation and some studies consistently report an increase in the frequency and ease of     defecation, stool volume and softness.      Although literature suggests kiwifruit consumption improves constipation symptoms, no studies     have been carried out in adults and in Mediterranean patient populations, characteristic for     its differential nutritional habits. The aim of the present study was to test the effect of     kiwifruit consumption on functional constipation in a Spanish adult population.   "
81762|NCT02215772|"     Study to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS,     and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a     single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to     evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI     44370 BS to healthy male volunteers   "
81763|NCT02215759|"     Evaluation of safety, tolerability and pharmacokinetics of multiple rising oral doses of BI     44370 TA in healthy male and female volunteers   "
81764|NCT02215746|"     The objective of this trial was to evaluate the relative oral bioavailability and     pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets     (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and     tolerability of the substances.   "
81765|NCT02215733|"     The primary objective of this study was to assess whether angiotensin blockers (ARBs) and     telmisartan in particular, are associated with an increased overall risk of the four most     common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective     was to explore these effects separately for each of the four cancers and in combination with     angiotensin-converting-enzyme-inhibitors (ACEIs).   "
81798|NCT02215304|"     Study to evaluate the safety and tolerance of three probiotic bacteria intake by healthy     infants. Participants are divided at random and unknown to the researchers, in four groups,     three of which receive one of three probiotic bacteria while the fourth group receives     placebo product.   "
81769|NCT02215681|"     Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media     with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are     in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control.     50 Children in the acupuncture group will receive standard treatment combined with     acupuncture for 3 months. 50 Children in the control group will receive standard treatment     only, for the same time period. After 3 months, both groups will be reassessed for OME.     Children with no improvement from both groups will be assigned for tympanostomy.      Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be     collected, analyzed and evaluated for group differences.   "
81770|NCT02215668|"     Mammography is a systematic way in the main programs of screening for breast cancer in women     over 40 or 50 years old, according to screening programs, but most research has shown a     frequency of discomfort and pain during the examination mammography. This study is a     randomized controlled trial, whose intervention will be a sequence of exercises body warming     and muscle stretching, performed systematic manner and supervised by a physical educator. It     is expected to find in this study a possible impact of physical exercise in reducing pain     after mammography examination.   "
81771|NCT02215655|"     Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor     for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as     74% in ESRD patients and has been shown to be most related to psychosocial factors including     attitudes. There is limited data on the influence of attitudes and perceived autonomy support     on phosphate binder adherence and these two psychosocial constructs can be positively     influenced through the use of motivational interviewing skills to increase autonomous     motivation. Furthermore, racial disparities are known to exist in ESRD however and there are     still gaps, which exist in understanding the determinants of disparities in adherence in     vulnerable patients with ESRD.      In this study, the investigators seek to determine the impact of motivational interviewing on     phosphate binder adherence in diverse ESRD patients. The investigators will ask all the     subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy     support and phosphate binder adherence. The investigators will administer motivational     counseling to subjects in the intervention arm of the study, at baseline and 1 month after     recruitment. The investigators will ask all the subjects to fill out the same surveys 2     months after recruitment and the investigators will compare subjects who underwent     motivational interviewing to those who did not.   "
81772|NCT02215642|"     Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports     concluded nutrition status and lifestyle factors were associated with colorectal cancer risk,     however, the influence of nutrition and lifestyle factors on cancer outcome in colorectal     cancer survivors is largely unknown.The investigators will explore the impact of nutrition     status, life style, dietary pattern, obesity, physical activity, depression, diabetes,     aspirin use and vitamin supplement on colorectal cancer outcome. The investigators will     recruit approximately 50,000 patients as a prospective study cohort. During follow up, the     investigators will explore the association of these factors with disease-specific survival,     disease-free survival and overall survival of patients. The investigators believe that this     project will facilitate the establishment of domestic nutrition and lifestyle data of     colorectal cancer of China, and the improvement of the quality of clinical management of     patients with colorectal cancer.   "
84350|NCT02181946|"     The purpose of this study was to determine the effects of nevirapine on the steady state     pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine     when given in combination with fluconazole.   "
81773|NCT02215629|"     The main purpose of this study is to test the safety and efficacy of VS-4718 in two types of     leukemia patients and to find the right dose of VS-4718 for future clinical trials.      Other purposes of this study include:        -  Testing for study drug VS-4718 levels in blood over time and what happens to the study          drug in patients.        -  To find out if there are certain biomarkers in leukemia patients that predict if and how          4718 study drug may or may not work.   "
81774|NCT02215616|"     The primary objective of this study is to assess the efficacy of laquinimod 0.5, 1.0, and 1.5     mg qd in patients with HD after 12 months of treatment using the UHDRS-TMS.   "
81775|NCT02215603|"     Great controversy exists with respect to the optimal or the minimum volume, intensity, and     frequency of physical activity capable of attenuating the hazards of prolonged sitting on the     metabolic profile. Thus, our study aims to comprehensively investigate the effects of     disrupting prolonged sitting with different physical activity protocols on metabolic risk     factors in sedentary males.      Ten sedentary males will take part in this randomized cross-over trial consisting of four     27-h conditions. All conditions will be identical except for the physical activity: prolonged     sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged     sitting+interval standing intervention (STAND), participants will stand for 15 min every 30     minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity     exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a     treadmill (energy-matched to STAND), after which they will sit for the remaining time; and     prolonged sitting+moderate-intensity exercise bout +interval standing intervention     (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a     treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes     (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and     cytokines will be determined.      The investigators expect that disrupting prolonged sitting with intermittent standing and a     moderate-exercise bout will positively affect the metabolic profile of the participants.     Furthermore, we will investigate if combined, these strategies will have an additive effect.   "
81776|NCT02215590|"     The purpose of this study is to:        1. Test the walking functionality of people following Acquired brain injury (ABI)        2. Suggesting a new treatment for their walking impairments        3. Follow-up of motor learning ability and balance after intervention within this          population      The investigators intend to target dynamic stability and gait after ABI, in a group of     individuals with ABI who have persistent balance and mobility deficits despite being able to     walk independently and having high scores on standard clinical balance measures.      Interventions: Training with Re-Step system shoes.      In this study there is no control group.   "
81799|NCT02215291|"     Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or     endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural     data for participating physicians, including, but not limited to, imaging data, clinical     utility data, demographics, pathology, treatment, and surveillance.   "
81777|NCT02215577|"     Study Title Comparison of two different models of liver growth stimulation in advanced     colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection      Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial      Study duration The planned duration of study participation for an individual subject from     inclusion to follow-up are 3 years      Primary investigator:      Per Sandstrom (Linköping)      Number of subjects 100 patients randomized in a 1:1 randomization      Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring     liver resection, but are not resectable in one step because of a future liver     remnant/standardized total liver volume of < 30 % extrahepatic metastatic disease is not an     exclusion criteria if they can be addressed surgically in the future      Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients,     primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with     an acceptable level of complications and perioperative mortality.      To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal     embolization or portal ligation leading to a shorter treatment period.      In addition the investigators aim to study if ALPPS may reach these goals without detectable     or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a     higher proportion of patients reaching R0.      Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate     resected compared to the previously established methods with portal ligation or embolization.      This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien     grade 4 complication or higher (H0).      The ALPPS approach will increase the growth rate compared to portal embolization/ligation     measured one week after the primary intervention.   "
81778|NCT02215564|"     The objective in this observational cohort study of young adults sampled at three intervals     during the academic year is to ascertain if there is carriage of B. pertussis in asymptomatic     individuals. We hypothesize that in asymptomatic college students there is no carriage of B.     pertussis detectable by polymerase chain reaction (PCR) assay.   "
81779|NCT02215551|"     Decompressive laminectomy (DL) is the most common type of back surgery performed in older     adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal     causes pain and trouble walking. An estimated one in three people who undergo DL do not get     well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside     of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do     poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of     treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61 The     aim of this study is to identify conditions other than LSS that place Veterans at risk of     poor DL outcomes so that future comparative effectiveness studies can be designed that     examine the impact of a more comprehensive approach to treatment. Investigators believe that     a patient-centered rather than a disease-centered approach will lead to superior outcomes,     less suffering, and more appropriate use of health care resources.   "
81780|NCT02215538|"     This study will look at the effectiveness of osmotic release oral system (OROS)     methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in     adults. Concerta has received FDA approval for childhood ADHD and there is documentation that     it is effective in adult ADHD. However this trial will explore its effectiveness in treating     symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III) criteria. Subjects     will experience one screening visit and one baseline visit. Those who meet admission criteria     will enter the double-blind phase. This will involve two 4-week treatment periods one of     which will involve the use of Concerta and the other a placebo pill. Subjects who complete     the double-blind phase will be allowed to enter a 180-day, open-label Concerta phase designed     to assess long-term effects.   "
81781|NCT02215525|"     A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of     extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement     (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic     subjects with chronic hepatitis C.   "
81782|NCT02215512|"     In this dose-escalation study, the safety and tolerability of escalating dose levels of     RRx-001 administered intravenously twice a week in subjects with brain metastases receiving     whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is     identified, further (up to approximately 30) participants will be recruited. The study will     use MRI to monitor changes in tumor blood flow associated with RRx-001.   "
81783|NCT02215499|"     This study is being conducted to evaluate the safety, tolerability, blood distribution and     effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.   "
81784|NCT02215486|"     The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ     systems such as the respiratory, circulatory, and urinary systems. It consists of two major     components, the parasympathetic nervous system (PNS) and the sympathetic nervous system     (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the     state of chemical and metabolic balance within an organism; it is disturbed in situations of     uncontrolled stress.      Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full     body massage, with limited assessment of ANS function, and lacked control groups.      The effects of head massage therapy (HMT) on regulating the activity of the ANS have not been     studied before. In this pilot study, we propose that by randomizing 10 participants to     sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of     measuring the ANS activity (spectral analysis of Heart Rate Variability [HRV] as well as     Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT     in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a     better and balanced profile of autonomic nervous system after receiving massage.   "
81785|NCT02215473|"     Bacteremia represents the presence of live germs in the blood stream. Patients with gum     disease show damaged tissues and seem to be more susceptible to bacteremia. In fact, daily     activities such as mastication can induce bacteremia in these patients. Dental procedures     related to bleeding also induce bacteremia. However, there are many questions that should be     clarified. Among them, clinical strategies that are able to reduce the levels of germs in     blood should be determined. This desirable effect could be particularly important for some     patients, for example, for those at higher risk for endocarditis. Therefore, this study     tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental     instrumentation could reduce the levels of bacteria in the blood. In addition, the occurrence     and magnitude of bacteremia in patients with gum disease were investigated by two different     laboratorial techniques. After receiving verbal and written explanations and after signed the     informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having     dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse     use and dental instrumentation and b) dental instrumentation with no mouth rinse. In a     preliminary visit volunteers underwent a complete periodontal examination which included     clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue     and dental plaque samples collected with paper points), saliva (to determine volume and     biological indicators) and gingival crevicular fluid sampling (to monitor gingival     inflammation profile). In the next visit, dental instrumentation was performed under local     anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant.     Blood samples were collected before any dental procedure, 2 and 6 minutes after dental     instrumentation. Oral hygiene instructions and periodontal treatment were performed in     additional visits according to individual needs. Finally, the relation between bacteremia and     several indicators of periodontal status was investigated.   "
81786|NCT02215460|"     Periodontitis is a form of gum disease that affects many people in the world. Its traditional     protocol of treatment includes oral hygiene instruction and dental scaling to remove debris,     dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option     also usually cheaper. In this last one, all above described procedures are performed within     24 hours. However, up to now comparative effectiveness between these both types of treatment     is not well understood. For, example it is not clear if patients treated in the shorter-time     experienced more pain. Therefore, the present study used several parameters to clarify     whether beneficial differences between these therapeutic protocols exist or not. In addition,     aspects that could help clinicians' and patient's decisions such as experience of pain and     anxiety related to dental treatment were also investigated. After receiving verbal and     written explanations and signed the informed consent form 150 individuals (n=15/group) having     the most common type of periodontitis in adults were randomly allocated to be treated in 4     weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were     performed alone or in conjunction with antimicrobial agents: a mouth rinse containing     chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at     baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral     debris and malodor; quantification of bacteria in plaque samples collected with paper points     from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect     information about oral condition, daily activities, pain and anxiety related to dental     treatment.   "
81787|NCT02215447|"     Gastrointestinal Neuroendocrine Tumours (NETs) are gaining increasing recognition as a highly     prevalent disease, responsive to a number of therapies, some of which are proven in modern     randomised controlled trials, but many of which still require high quality clinical trial     evidence to confirm their effectiveness and guide their use in practice. This study is the     first prospective trial to evaluate modern combination chemotherapy. The study will determine     whether Carboplatin and Paclitaxel NAB is a suitable combination for comparison in a     subsequent randomised controlled phase III international trial.      Given the paucity of randomized studies in NETs, there are no clear evidence based     guidelines. Patients are treated according to guidelines established for small cell lung     cancer, incorporating platinum (cisplatin or carboplatin) based doublet treatment with     etoposide. Although these tumors are initially highly chemosensitive, the natural history of     this disease is such that relapses occur early, which ultimately leads to a very poor     prognosis. Almost all clinical trials investigating cytotoxic chemotherapy in NETs are small     single arm studies and guidelines are derived from expert opinion and from extrapolating     results from small cell lung cancer studies. Prospective clinical trials in this group of     patients needs to be conducted to establish an evidence based standard of care and to improve     the prognosis of this highly aggressive group of tumors.      Participants will receive albumin bound paclitaxel (ABRAXANE®) 100 mg/m2 administered as an     intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21 day cycle. Carboplatin     will be given at an Area Under the Curve (AUC) = 5 mg/min/mL on Day 1 only of each 21 day     cycle administered over 30 mins, beginning immediately after the completion of albumin bound     paclitaxel administration. Participants can continue treatment at the investigator's     discretion until disease progression, development of an unacceptable toxicity, or withdrawal     of consent.   "
81788|NCT02215434|"     Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake     inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms     such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.      Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder     (HSDD) in women has been demonstrated in studies including naturally and surgically     menopausal women, either alone or in combination with estrogen, with or without progestin     therapy.   "
84383|NCT02181517|"     This is a safety and efficacy study of abicipar pegol in patients with neovascular     age-related macular degeneration to establish comparability between Japanese and     non-Japanese.   "
81789|NCT02215421|"     A 20 episode video game called Mommio simulates parent-child feeding interactions for parents     of 3-5 year old children within a storyline addressing a problem commonly reported by parents     (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the     vegetable), thereby training parents in effective food parenting practices. This research     evaluates whether the 20 episodes targeting barriers identified by parents across five levels     of difficulty influences vegetable parenting practices and children's dietary intake. We had     to discontinue the study since changes in commercial availability of game development     software required reprogramming and available funding did not allow for completion of game     programming. Thus, no game evaluation was possible.   "
81790|NCT02215408|"     The study will test whether a pharmacist-run cardiovascular risk service (CVRS) at the     University of Iowa can increase use of national standards of care in clinics   "
81791|NCT02215395|"     To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of     a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository     or cream).   "
81792|NCT02215382|"     The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine     combination on hemodynamic parameters and intraocular pressure during tracheal extubation.      This prospective, randomised study was designed to compare two reversal methods with respect     to changes in IOP, heart rate and blood pressure during tracheal extubation period.   "
81793|NCT02215369|"     The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins.     AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this     study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment     (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure     EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of     IPVs.   "
81794|NCT02215356|"     This randomised, multi-center, controlled trial is designed to assess the efficacy and safety     of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in     non-small cell lung cancer   "
81795|NCT02215343|"     The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet     and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged     population, and if the diet-induced modulation of the gut microbiota mediates changes in     metabolic risk markers.      Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in     the gut microbiota composition and to affect markers for insulin sensitivity, lipid     metabolism and inflammation. The investigators hypothesize that the effect of both     interventions on the metabolic risk markers will be partly mediated by the diet-induced     changes in the gut microbiota composition.   "
81796|NCT02215330|"     Central serous chorioretinopathy (CSC) is supposedly the fourth most common non-surgical     retinopathy after age-related macular degeneration, diabetic retinopathy and branch retinal     vein occlusion. The disease was first described by Albrecht von Graefe in 1866 as a     'recurrent central retinitis' and is nowadays commonly known as 'central serous     chorioretinopathy', a term mainly coined by Donald Gass in the late 1960s.      Although the disease has been known for decades, the underlying mechanism is not yet fully     understood. Numerous studies have shown an involvement of the retinal pigment epithelium     (RPE) and the choroid which lead to accumulation of subretinal fluid with subsequent     detachment of the neurosensory retina.      Among several assumed risk factors, high serum glucocorticoid levels seem to be related to     the occurrence of CSC.      CSC typically affects young, male patients unilaterally and causes decreased and distorted     vision, often associated with metamorphopsia, micropsia, dyschromatopsia and reduced contrast     sensitivity. CSC can occur in an acute or chronic form. However, there is no agreement in the     literature concerning the duration of the two forms. Some authors define CSC as chronic if     there is persistent subretinal fluid for at least 6 months 11, others speak of chronic CSC     when symptoms last longer than 3 months. In contrast there are studies where CSC is defined     acute within the first 4 months. Spontaneously absorption is possible in up to 50% and     normally leads to the recurrence of a normal visual acuity. Chronic CSC can result in a wide     spread RPE damage and in a constantly reduction of visual acuity.      Structural changes in the retina and RPE have been found about 2 months after onset of the     disease. Those changes can cause accumulation of photoreceptor outer segments, lead to     consecutive atrophy of the photoreceptor cells and are associated with a loss of visual     acuity.      Different concepts of treatment exist, but none of these may be deemed to be the golden     standard. In the past few years several studies where CSC was treated with photodynamic     therapy (PDT) or half-fluence PDT showed good visual outcomes and morphologic reconstitution.     However, PDT is a destructive method which causes structural damage and can trigger other     severe complications like choroidal ischemia and iatrogenic CNV. Furthermore, CSC is a     self-limiting disease in many cases and physicians often hesitate to perform a relatively     destructive therapeutical approach to treat a potentially self-limiting disease.      A newer, non-destructive therpeutical concept is the oral use of eplerenone a     mineralocorticoid receptor antagonist. It is currently used in the treatment of hypertension     and congestive heart failure. In the recent literature it was shown that eplerenone improved     CSC and no serious adverse effects were observed in any case. However, no randomised     controlled studies were performed comparing eplerenone with placebo to evaluate the clinical     effect.   "
81797|NCT02215317|"     Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is     crucial in risk assessments and therapeutic recommendations for affected individuals. The     Sleep and Stent Study is a multi-center observational study investigating the relationships     between OSA and cardiovascular outcomes in patients treated with percutaneous coronary     intervention (PCI).   "
81800|NCT02215278|"     Recent iron absorption studies with biofortified beans indicated that the currently developed     beans do not provide an extra amount of iron compared to normal iron beans. This effect was     ascribed to the inhibitory nature of phytic acid (PA), which is present in high     concentrations. A possible solution to alleviate problems associated with the high PA     concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit     a good agronomic performance, were tested in a human absorption study in Switzerland and     provided a higher amount of bioavailable iron compared to their parent beans with normal PA     concentrations. However, the informative value of the study for the real life situation is     limited due to the simple study design with a relatively large amount of isotopic label added     extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron sufficient     women in a non-bean consuming population. Additional investigations are necessary to verify     that iron bioavailability from lpa beans is high and that their performance is better     compared to common biofortified beans in a real life situation. A multiple meal randomized     crossover study in Rwandese women with low iron status will be done to measure iron     absorption from three different beans (lpa bean line, biofortified high iron bean, normal     iron bean as a control). During the study, the subjects will receive multiple meals to reduce     the amount of extrinsic label, therefore more closely simulating hypothetical dietary iron     intake from lpa beans. This will also allow to avoid an overestimation of the effect of     inhibitors and to minimize the influence of intra subject day to day variation. The study     will be divided into two parts. In part one, two of the three bean varieties will be fed as     part of composite meals over several days (morning and lunch) and in part two, the remaining     bean will be administered as part of composite meals over several days (morning and lunch).     Iron absorption from the three varieties will be measured and compared with erythrocyte     incorporation of stable isotopic labels 14 days after test meal administration.   "
81801|NCT02215265|"     The main objectives of the PATHOS study are:      To assess whether swallowing function can be improved following transoral resection of     HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to     personalise treatment, based on disease biology (HPV status and pathology findings), to     optimise patient outcomes.      To demonstrate feasibility of recruitment- if the phase II recruits successfully, PATHOS will     continue to a Phase III study aiming to show non-inferiority of survival in the reduced     intensity treatment arms.   "
81802|NCT02215252|"     The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a     monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral     neuropathy (DPN)   "
81803|NCT02215239|"     The purpose of this study is to investigate the effectiveness of intervention applying WHO     Healthy Workplace Framework and Model to enhance the level of physical activity on employees.     This research is an experimental intervention study recruiting two working types in four     workplaces. Two working types are: (1) Working type A: Workers tend to be seated during work     hours. Two telecommunications enterprises will respectively stand for the experiment group     and the control group. (2) Working type B: Workers tend to be standing during work hours.     Likewise, two different enterprises will respectively stand for the experiment group and the     control group. Purposive sampling method will be used to select the experiment group. The     intervention plan is to implement a cyclic or iterative process recommended by WHO.   "
81804|NCT02215226|"     Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and     their infants who develop disease versus those who do not. Use this comparison to establish     antibody levels associated with reductions in risk of GBS disease in infants aged less than     90 days.   "
81884|NCT02214173|"     The purpose of this study is to investigate the effects of the nutritional supplement rice     bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with HIV.     The hypothesis is that there will be a significant improvement in metabolic syndrome and     immune variables in HIV-positive participants in the intervention group compared to the     control group.   "
81805|NCT02215213|"     The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the     study participants will receive Vitamin D in supplement form. Pregnant women will be     individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till     the time of delivery.A blood sample will also be collected from the participant at the time     of recruitment /before the starting of the supplementation for the assessment of Calcium,     Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D     level to assess vitamin D status will be done after completion of the supplementation phase     at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan     University laboratory   "
81806|NCT02215200|"     This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at     least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte     colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at     least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1     Diabetes (T1D).      The primary objective of the study will be to determine the safety and ability of low dose     ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D     patients demonstrating residual beta cell function.   "
81807|NCT02215187|"     The primary purpose of this research is to evaluate the impact of a telehealth-based,     cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult     informal military family/friend caregivers of OIF/OEF service members with a     deployment-related TBI.   "
81808|NCT02215174|"     Statins are the first-line and most commonly prescribed drugs for the prevention of     cardiovascular diseases and stroke in the world. Our preliminary studies suggest that     Caucasians might have a higher risk of developing potentially life-threatening drug-drug     interactions than Asians when taking statins. Drug-drug interactions occur in the body when     two or more drugs interact in a way that alters their effectiveness and/or toxicity. These     interactions are becoming an increasingly severe problem with statin usage since patients at     higher risk for cardiovascular diseases also take statins combined with many other drugs,     such as antihypertensive and diabetic drugs. Our study is aimed at understanding the     molecular factors and providing a sound basis for the interethnic dosage and response     differences for statins.      Drug-transporting proteins in intestine and liver tissues are responsible for taking up     statins into the blood. It is hypothesized that there are interethnic function differences of     these proteins and that they account for differences in statin blood levels between     Caucasians and Asians and the frequency and/or severity of their respective drug-drug     interactions. A clinical study will be conducted with Caucasian and Asian subjects undergoing     gastric bypass surgery so excess intestine and liver tissue can be acquired as part of the     standard procedure. Protein levels will be quantified in the tissues and correlate them with     different statin blood levels.   "
81818|NCT02215044|"     Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was     given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15     every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and     characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor     marker response in response to the combination of BI 2536 with gemcitabine in patients with     locally advanced or metastatic pancreatic adenocarcinoma.   "
81819|NCT02215031|"     Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for     intravenous (i.v.) infusion   "
81809|NCT02215161|"     Abiraterone acetate is now considered the standard of care for patients with metastatic     castrate-resistant prostate cancer (mCRPC) in the pre-chemotherapy setting. Patients with     primary or acquired abiraterone resistance typically have rapidly progressive, refractory     disease for which limited treatment options are available. The development of new therapies     in mCRPC requires a focus on patients with primary or acquired resistance to abiraterone.     Patients with abiraterone-refractory mCRPC have a poor prognosis overall with median survival     after progression of disease at approximately 19 months. While chemotherapy is a standard     approach in this setting, it is refused by many patients and clinicians due to toxicity     concerns.      Selinexor is a first in class Selective Inhibitor of Nuclear Export (SINE) that specifically     blocks the karyopherin protein Exportin 1 (XPO1/Exportin 1). XPO1 is a key regulatory protein     responsible for the nuclear export leading to functional inactivation of tumor suppressor     proteins (TSPs) and is up-regulated 2-4 fold in all cancers studied to date. Selinexor, given     orally, has demonstrated potent anti-cancer activity in animal models of prostate cancer     including inhibition of PC3 driven bone metastasis.The goal of this trial is to evaluate the     potential for a progression free survival benefit associated with Selinexor administration in     patients with abiraterone-refractory mCRPC.      Single agent phase II open label study of Selinexor in patients with mCRPC with prior therapy     with standard hormone ablation agents and abiraterone. A maximum of 54 evaluable patients     will be accrued for this study, provided the early stopping criteria are not met.      The starting dose for all patients will be an oral dose of 65 mg/m2, given twice per week at     least 48 hours apart. Tablets for Selinexor oral administration will be supplied in two (2)     strengths: 10 and 25 mg of active ingredient per tablet. Dexamethasone will be coadministered     at a dose of 2 mg twice daily on the day of dosing and the day after.      Patients will be followed for 30 days after completion of treatment or removal from study, or     until death, whichever occurs first. Patients removed from study for unacceptable treatment     related adverse event(s) will be followed until resolution or stabilization of all treatment     related adverse events to Grade 2 or lower.   "
81810|NCT02215148|"     To assess the pharmacokinetic profile of tolvaptan in critically ill acute brain injury     patients and to secondarily evaluate the clinical response and safety of tolvaptan in acute     brain injured patients   "
81811|NCT02215135|"     Corifollitropin alfa, single dose administered sustains multiple follicular development for 7     days. However, It may induce ovarian hyperstimulation syndrome (OHSS), especially in high     responder women such as patients of polycystic ovary syndrome (PCOS). In GnRH antagonist     protocol with agonist triggering of final oocyte maturation, following embryo     cryopreservation can almost eliminate the risk of OHSS. To decrease the injection burden and     prevent OHSS in PCOS patients undergoing IVF treatment, ovarian hyperstimulation with     Corifollitropin alfa in GnRH antagonist protocol and GnRH agonist triggering of final oocyte     maturation, following elective embryo cryopreservation was designed in this study. The     purpose of this trial was conducted to confirmed whether this novel protocol could prevent     OHSS, decreased the injection burden of PCOS patients and single dose corifollitropin alfa     could support multiple follicular growth for 7 days.   "
81812|NCT02215122|"     This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate     (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations     (250 µg FP and 50 µg SAL) from the Advair® Diskus®, Seretide™ Accuhaler™ and CRC749 inhalers.   "
81813|NCT02215109|"     The authors investigated the consecutive change of retinal vessel's diameter in affected eye     and fellow eye of Branch Retinal Vein Occlusion.   "
81814|NCT02215096|"     This Phase I, open-label, dose-finding, multicenter study is designed to determine the     recommended Phase II dose (RP2D) for the combination of an orally administered     Phosphatidylinositol-4,5-bisphosphate 3-kinase beta (PI3K-beta) inhibitor (GSK2636771) with     enzalutamide. Subjects with phosphatase and tensin homolog (PTEN)-deficient metastatic     castration-resistant prostate cancer (mCRPC) who are receiving a stable dose of enzalutamide     with a recently demonstrated progression (either by RECIST [Response Evaluation Criteria In     Solid Tumors] version 1.1, prostate-specific antigen [PSA] progression, and/or progression in     bone) per the Prostate Cancer Working Group 2 (PCWG2) criteria will be enrolled. Eligible     subjects will be enrolled in the Dose-Escalation Phase to determine the maximum tolerated     dose (MTD) of the combination therapy using a modified 3+3 dose escalation procedure. The     safety, pharmacokinetics (PK) and clinical efficacy will also be assessed to guide the     selection of the RP2D. The starting dose will be GSK2636771 300 mg once daily in combination     with the recommended dose (160 milligram [mg] once daily) of oral enzalutamide. Once the RP2D     has been established, additional subjects will be enrolled in the Dose Expansion Phase to     further evaluate the safety, PK and preliminary clinical activity. Safety assessments will be     performed throughout the study including physical examinations, vital signs, clinical     laboratory tests, 12 lead electrocardiograms and monitoring of adverse events. Blood samples     will be collected for pharmacokinetic analysis. Subjects will continue treatment until an     unacceptable toxicity, disease progression, withdrawal of consent or death occurs. A     post-treatment follow-up visit will be performed within 30 days of the last dose of study     treatment. Xtandi is a registered trademark of Astellas Pharma Inc   "
81815|NCT02215083|"     The purpose of the study is to determine whether daily, high-dose administration of     l-glutamine can reduce numbness and tingling caused by a taxane chemotherapy in patients with     breast cancer.   "
81816|NCT02215070|"     The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in     reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic     stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing     acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.   "
81817|NCT02215057|"     General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as     most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were     performed deep into the orbit, but it is now accepted that peribulbar injections using     shorter needles are safer. In the last few years, continuing concern over the rare but     serious complications of sharp needle blocks has led to increasing interest in the use of     sub-Tenon`s blocks utilizing a blunt cannula 1-5.      Even with the use of blunt canulae sub-Tenon`s block, serious problems can still occur,     especially in myopic patients with large axial length. In phakic IOL surgery,topical     anesthesia has been used successfully for years. Topical anesthesia has several advantages     over regional infiltrative techniques, the foremost of which is the abolition of any risk of     inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient     satisfaction, but still there are some patients that experience intraoperative discomfort.      In this study we compared topical anesthesia alone with topical anesthesia plus intracameral     lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision     implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common     adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory     blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL     placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be     because of the direct action of lidocaine on the iris, which in turn causes muscle     relaxation.   "
81820|NCT02215018|"     To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI     44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation     and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further     doses.   "
81827|NCT02214927|"     -  Characterisation of the relative bioavailability of the IR-tablet vs. oral drinking          solution (no primary endpoint in a statistical sense)        -  Safety and tolerability of the IR-tablet formulation and solution        -  PK profile of the single ascending doses of the IR-tablet formulation (including          analysis of dose proportionality)   "
81828|NCT02214914|"     First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of     BI 11634 on coagulation parameters   "
81829|NCT02214901|"     Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS   "
81830|NCT02214888|"     Study to determine the efficacy (including American College of Rheumatology (ACR) 20 response     rate), safety, and pharmacokinetics of BIRB 796 BS as monotherapy in patients with moderate     to severe rheumatoid arthritis who have failed at least one disease modifying antirheumatic     drug (DMARD)   "
81831|NCT02214875|"     This study aims to address the research question: Will continuous quality improvement, using     a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of     HIV-infected pregnant women and mothers at six and 12 months postpartum?      Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to     systematically improve services and health outcomes. The Break Through Series (BTS) is a     specific CQI approach is a short-term (6- to 15-month) learning system that brings together     teams from several hospitals or clinics (collaboratives) to seek improvement in a focused     topic area through a common process of data sharing and review Primary Objective To assess     whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at     health facilities implementing CQI-BTS approaches than at health facilities not implementing     CQI-BTS approaches.      Secondary Objectives      To assess whether implementation of CQI-BTS initiatives at health facilities increases:        1. Uptake of PMTCT services by HIV-infected pregnant women;        2. Retention-in-care of HIV-infected women at twelve (12) months postpartum;        3. Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age;        4. Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected          women in health facilities.   "
81842|NCT02214732|"     Anxiety, stress and depression are common during pregnancy and in the postpartum period. The     lack of empirically supported, non-pharmaceutical interventions for psychological distress in     pregnancy is a significant gap in the literature, especially given many pregnant women's     preference for non-pharmaceutical treatments. This study will evaluate the efficacy of     Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological     distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women     endorsing high levels of distress.   "
82053|NCT02211950|"     The objectives were to investigate the relative bioavailability of BI 44847 in different     racial groups (white, Asian, and African subjects) and to investigate the effect of different     types of diet and acarbose coadministration on the bioavailability of BI 44847 in white     subjects.   "
81832|NCT02214862|"     The PET tracer [F18]-FDDNP has a specific affinity for lesions containing tau protein.      The study consists of two phases:        -  In the first (cross-sectional) phase it will be assessed the uptake of [18F]-FDDNP in 10          cases with progressive supranuclear palsy (PSP, a tauopathy) en 10 with multi-system          atrophy (MSA, a non-tauopathy), along with 20 individuals with Unclassifiable          Parkinsonism, as previously defined in a European cohort study.        -  In the second (longitudinal) phase it will be prospectively followed the 20          unclassifiable patients (at 6, 12 and 18 months) by means of validated scales and          accepted diagnostic criteria in order to try to correlate their eventual clinical          diagnosis with baseline PET findings. On this basis, we endeavour to estimate the          ability of this technique to detect in vivo underlying tau pathology in subjects          initially unclassifiable on clinical grounds.      We hypothesized that:        1. Patients with clinically definite PSP will present an increased uptake in basal ganglia,          brainstem and cerebellum.        2. Patients with clinically defined MSA will not present specific uptake.        3. Part of unclassifiable patients with parkinsonism will present a pattern of uptake          similar to patients with clinically defined PSP and this part along the clinical          follow-up will be meet clinical criteria for diagnose of PSP   "
81833|NCT02214849|"     The purpose of this study is to find out if a two-way texting platform to be used as an     adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among     women enrolled in the WIC program in Connecticut. The hypothesis of the study is that     providing additional information and support through text messaging starting in pregnancy and     continuing after the birth of the child will increase exclusive breastfeeding rates during     the first six months of life.   "
81834|NCT02214836|"     The purpose of this study is to determine whether new software processing of ultrasound     images can improve detection and size determination of kidney stones.   "
81835|NCT02214823|"     Project Summary: Patients who have a length of stay four or more days in ICU and requiring     mechanical ventilation assistance to breathe for more than 48 hours will be invited to     participate. Participants will be randomised to either receive Functional Electrical     Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously     been shown to improve physical function, patients who receive cycling as a treatment will     have one leg that cycles and the other leg that cycles with assistance of electrical     stimulation as we want to establish the effectiveness of the addition of electrical     stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be     measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive function     will also be measured at hospital discharge, 6- and 12-month follow-up. A small group of     patients in this study will be invited to provide samples of blood, urine and muscle at ICU     admission and discharge to try and determine what happens to muscle in patients who are     critically ill.      Significance of the Project: This is an important study because the development of     ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function.     Early treatment to maintain strong muscles during an intensive care stay may help speed up     recovery and enhance participation in other rehabilitation treatments and improve functional     activities and cognition. These are important objectives for both patients and their     families. In addition understanding why the muscles become so weak so quickly in patients in     ICU will help to develop treatments that may help to maintain muscle strength.      Study Hypotheses:      Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at     hospital discharge.      Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at     6 month follow up.      Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic     signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care     rehabilitation.   "
81836|NCT02214810|"     Postsurgical pain may effectively be treated with a multimodal approach that incorporates the     use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be     effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to     reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease     hospital length of stay. However, local anesthetics, via wound infiltration, are often     short-acting and do not meet the duration of postsurgical pain due to their solubility and     protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine     that allows for 72 hours of postsurgical analgesia with a single injection. This formulation     has been shown to have little to no adverse effects; although some studies have reported     adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and     dizziness. The occurrences of these adverse events were still less than the placebo cohort.   "
81837|NCT02214797|"     The aim of this study is to assess visual performance of prototype soft contact lens designs     compared to commercially available contact lenses over one-week of lens wear.   "
90842|NCT02097056|"     This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating     safety and efficacy of donepezil hydrochloride in patients with moderate to severe     Alzheimer's disease.   "
81838|NCT02214784|"     Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens     when physical activities such as running, jumping and lifting etc are carried out or when     increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.      There are various treatment options available - surgical operations, pelvic floor     exercises/muscle training and electrical stimulation. This study aims to prove that using the     Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and     tone them and in doing so improving stress urinary incontinence. We are comparing the     Neurotech Vital device with an altered Neurotech Vital device that does not give the same     stimulation treatment. There is a 50% chance of you receiving the altered device, if you do,     you will be offered the non-altered Neurotech vital device after your first 12 week treatment     programme. Both devices are identical in looks, but give different stimulations through the     skin contact electrodes.   "
81839|NCT02214771|"     The study aims to describe the characteristics and the methods of management and follow-up of     patients treated with fidaxomicin for Clostridium difficile infection (CDI).   "
81840|NCT02214758|"     The aim of the study is to evaluate the impact of six month long nutritional and oral health     intervention on nutritional status, oral health, functional performance and hospital     admission/costs on older persons using home care services. Additionally, participants are     interviewed at home regarding their drugs use and this information will be compared with     medication information in electronic patient records.   "
81841|NCT02214745|"     To evaluate the demographic characteristics of patients suffering from mental retardation or     cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and     will be distributed amongst this population in order to identify these characteristics.   "
81864|NCT02214446|"     The purpose in this study was to investigate the current status, changes, correlation, and     predictive factors of the truth telling, hope, care burden, and quality of life during     treatment in primary caregivers of newly diagnosed children with cancer.   "
81843|NCT02214719|"     A closed loop system for diabetes care utilizing an insulin pump, continuous glucose sensing     and appropriate mathematical modelling to guide insulin dosing is a goal for those with Type     1 diabetes. Yet the cost of the associated hardware will be prohibitive for many people with     diabetes or their health care payers. Carbohydrate counting, insulin dose correction systems,     basal bolus regimens with or without an insulin pump all facilitate glucose control but     frequent adjustment to a diabetes regimen is a necessary cornerstone to successful diabetes     management; if all that is used is the regimen suggested by the health care provider at a     visit and this regimen is left unchanged until the next visit or contact then success will be     limited. A readily available user friendly program suitable for a smart phone or tablet would     have widespread applicability and benefit. The investigators hypothesize that such an app     linked into a web site that facilitated review of glucose records will be acceptable to     people with diabetes and improve glucose control. Our long term goal is to create an app that     can advise on diabetes management.   "
81844|NCT02214706|"     The purpose of this study is to improve the therapeutic outcome of laser therapy for port     wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser     and topical sirolimus.   "
81845|NCT02214693|"     This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and     tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.   "
81846|NCT02214680|"     In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan)     eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic     effect on the pupil, however the combined effect of alpha agonist and beta blocker has not     been studied.   "
81847|NCT02214667|"     Treatment adaptation and implementation study for adult jail inmates with co-occurring     substance use disorders.   "
81848|NCT02214654|"     The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger     anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.   "
81849|NCT02214641|"     This three-year award will pilot-test an innovative intervention, Resilient, Empowered,     Active Living with Diabetes (REAL), targeting underserved minority young adults with     poorly-controlled diabetes. The individually tailored, community-based intervention merges     findings of an in-depth needs assessment, principles of an evidence-based occupational     therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management     strategies. A proof-of-concept study demonstrated that REAL is feasible to implement,     acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to     produce positive changes in diabetes self-care and glycemic control. The study will randomize     80 young adults with diabetes to receive either the six-month REAL intervention or an     attention control condition. Blinded data collectors will assess glycemic control, diabetes     self-care behaviors and quality of life outcomes, as well as potential intervention     mediators, before and after the six-month intervention. It is anticipated that findings from     this pilot study will be used to inform a large-scale randomized controlled trial of the REAL     intervention.      The study's specific aims and hypotheses are as follows:      Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and     diabetes self-care.      Hypothesis: At 6 months (immediately following the intervention), intervention group     participants will demonstrate improvements in A1C and diabetes self-care as compared to     control group participants.      Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and     potential mediating mechanisms (to inform power estimates for a large-scale RCT).      Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in     secondary outcomes: diabetes-related stress and quality of life, depression, and life     satisfaction as compared to control group participants.      Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in     potential mediators of the intervention: habit strength, problem solving, activity     participation, self-efficacy and diabetes knowledge as compared to baseline.      Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine     intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures     (e.g. recruitment, retention, testing protocol).   "
81850|NCT02214628|"     The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered     in combination with anti-VEGF therapy   "
81851|NCT02214615|"     This research study is designed to investigate brain response using fMRI scan, and behavioral     responses, to treatment with the drug carbamazepine (CBZ) in patients with the painful sodium     channelopathy inherited Erythromelalgia (IEM). This study is designed to identify the central     nervous system (CNS) regions that are activated during ongoing or evoked pain attacks, and     the altered CNS response to CBZ treatment. This will advance our understanding of how IEM     affects the brain. We also hope to validate a pharmacogenic approach to the study of IEM by     use of an FDA approved drug. We hope, but cannot be sure, that subjects will directly benefit     from this study.   "
81854|NCT02214576|"     Tracheal intubation in the ICU is associated with significant complications and morbidity.     Desaturation is among the most frequent and hazardous complication, occurring in almost one     out of four intubations, that may in some instances lead to cardiac arrest; despite     appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does     not allow for apneic oxygenation and may not be performed in patients with neurological     impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with     acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is     currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our     first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to     determine its use as a means to ensure preoxygenation in those ARDS patients that require     intubation.   "
81855|NCT02214563|"     The purpose of this study is to determine whether cholecalciferol supplementation decrease     the blood concentrations of hepcidin-25 in hemodialysis patients.   "
81856|NCT02214550|"     The purpose of this study is to determine if some women with dysmenorrhea (painful periods)     are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives     (OC) can be used to reverse this chronic pain risk.      Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ     sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected     to reduce COS and decrease the risk of developing CPP.   "
81857|NCT02214537|"     The embryokinetics may be a new prognostic factor for choosing the human embryos with the     highest implantation potential. In order to identify the factors that may affect the rate of     embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen     tension, oocyte quality or type of medication used for ovarian stimulation. However there are     no published data with respect to the influence of sperm DNA fragmentation in the embryo     kinetic.   "
81858|NCT02214524|"     This is a randomized, open label, parallel two arm, clinical study, which compare the Bair     Hugger forced-air warming blanket and the conventional warming care practice in China on     patients undergoing major surgery to determine the impact of maintaining normothermia on     intraoperative blood loss, requirement for transfusion of packed red blood cells and the     changes of coagulation function.   "
90342|NCT02103556|"     The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the     treatment of constipation of patients undergoing hemodialysis.   "
81859|NCT02214511|"     Major depression disorder (MDD) is a frequent and disabling mental disorder with great risk     of recurrence and chronicity. Interpersonal factors are among the strongest predictors of the     course and duration of an episode of depression. More specifically, social rejection is one     of the most environmental risk factors of MDD. Targeted rejection predicts hastened onset of     major depression. On the other hand, healthy subject show prosocial behavior after social     rejection to reconnect to new source of social interaction. In addition to the potential     impact of social exclusion on MDD onset, depressed patients may be more prone to be rejected     as they encounter interpersonal difficulties and may less be able to reconnect to the social     group after rejection.      Recent neuroimaging data show that brain processing of social exclusion activate brain     regions that are central to the pathophysiology of MDD. Some of these regions are also known     to be activated during physical pain and may contribute to the aversive dimension of the     experienced rejection. Pro-inflammatory cytokines are involved in MDD physiopathology and can     induce social withdrawal behavior. Inflammation can modulate social interactions in mammals.     Moreover, after a social stress such as social rejection, blood cytokines increase. At a     cognitive level, self-esteem can modulate the sensitivity to social rejection.      The major objective of the trial is to study sensitivity to social signals in MDD patient     compared to healthy subject.      The investigators hypothesize in MDD patient : (1) decrease of rapid facial reactions (RFR)     to dynamic emotional faces expressing joy, (2) increase of RFR to dynamic emotional faces     expressing sadness, (3) decrease of prosocial reaction after experimental social rejection.      Secondary objective is to identify psychological and biological mediators We hypothetize in     MDD patient: (1)mediating effect of systemic inflammatory cytokines, an (2) mediating effect     of state self esteem 30 MDD patients and 60 healthy subject will be included. They will     encounter psychiatric and psychometric evaluation. Their facial EMG will be recorded to     assess RFR to dynamic emotional faces created by photo morphing from KDEF emotional faces     database, coupled to occulometric recording. Subjects will perform cyberball game as an     experimental inclusion or exclusion task and the trustgame task as an implicit evaluation of     their prosocial behavior. Questionnaires will assess explicit measurement of social rejection     pain and desire of affiliation. Inflammatory markers will be measured in a blood sample     before the cyberball task for every subjects and 6 hours later for 20 healthy volunteers.     Dosage of IL-6, IL-10, TNFa, IP-10, MCP-1, MIP-1b, Rantes, sIL-6Ra, IL1ra, VEGF, Leptin,     PECAM1, sTie2, sVEGFR1, sVEGFR2 will be performed by luminex technique and usCRP, srIL2 ans     sCD14 by ELISA technique.   "
81860|NCT02214498|"     Rationale:      The nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular     disease (CVD) risk than either daytime office, awake or 24hour mean blood pressure. In     general, when nocturnal blood pressure does not decline CVD risk is higher, usually referred     to as dippers versus non-dippers. Evening administration of treatment might lower     nocturnal blood pressure more effectively than morning administration, which is most commonly     advised.      The main hypothesis of this study is that evening administration of antihypertensive     medication might resume the dipping pattern in non-dippers and as a consequence might reduce     CVD risk more than morning administration.      Primary objective (in short):      -to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can     resume a dipping blood pressure pattern in non-dippers      Study design: A double-blind placebo-controlled cross-over study Each person will use for one     period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the evening,     and one period of six weeks the other way around   "
81861|NCT02214485|"     Objective: To determine the differential effectiveness of integrated care (IC) and lower     extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.      Method: The investigators randomize participants at Bei-Hu site from the Intervention study     of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial     into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks     and 6 months after initiation of the interventions.      Interventions:        1. IC: Participants visit the study site with health education, social activities, warm up,          stretch, and low intensity resistance exercise for about 1 hour per week. If any medical          problems or functional decline suspected during the visit, the case manager refers          participants to their primary care physicians for further managements.        2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining          using isotonic strength training machines each week. The intensity is set at 60-80% of 1          repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks          for individualized adjustments   "
81935|NCT02213510|"     ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called Zip     Surgical Skin Closure to replace sutures, staples and glue for closure of the skin layer for     surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin     Closure to standard sutures in patients undergoing cardiovascular implantable electronic     device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting     scar, and overall cosmetic appearance of scar. The study will be following participants for 3     months following CIED procedure.   "
81862|NCT02214472|"     Rumination syndrome is characterized by effortless recurrent regurgitation of recently     ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a     previous study the investigators showed that rumination is produced by an unperceived,     somatic response to food ingestion.      After having identified the key mechanisms of rumination, the investigators developed an     original EMG guided biofeedback technique with specific targets for correction, based on     EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study the     investigators showed the potential effectivity of this treatment. The current aim is to     validate this previous uncontrolled observation by a formal placebo-controlled, randomized     trial.   "
81863|NCT02214459|"     The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk     interventions. The DASH program of diet and exercise based lifestyle change is the most     well-established, evidence-based behavioral intervention to control HTN. Its recommendations     are central to HTN control national guidelines and consumer health products aimed at     behavioral management of HTN. However, translating these recommendations into     population-wide, inexpensive, sustainable programs have to date proven largely unrealized.     The objective of the proposed study is to determine the efficacy of a HTN intervention     behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about     the DASH diet, physical activity and HTN related behaviors from health coaches trained in     evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a     smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH     diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity     and 2) a web-based coaching portal through which health coaches view and respond to patients'     behavioral data and assist them in setting goals for changing behaviors consistent with their     HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine     improvement from baseline to 3-month follow-up in physiological (blood pressure, weight);     behavioral (diet & physical activity); and psychological (e.g., quality of life) measures     over a 3-month intervention. Completing this research will result in preliminary feasibility     and efficacy data for a larger randomized efficacy trial.   "
84384|NCT02181504|"     This is a safety and efficacy study of abicipar pegol in patients with neovascular     age-related macular degeneration to establish comparability between Japanese and     non-Japanese.   "
81865|NCT02214433|"     Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called     Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in     NCT02214355). The registrations have been revised so all parts of this single trial (Parts     A-C) are now included in this single registration (NCT02214433).      The primary purpose of each part is provided below:        -  10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450          (tablet formulation) under varying gastric conditions        -  40 volunteers participate in PART B to assess the safety, tolerability and PK of          multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or          twice daily.        -  An additional 10 volunteers participate in PART C which is designed to assess the          absolute bioavailability of various formulations of Debio 1450 under varying gastric          conditions      The dose administered during Part A is based on the safety, tolerability and PK data from     study Debio 1450-102 [NCT02162199], a single ascending dose (SAD) study, in which single oral     doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based     on the available safety and PK data from preceding cohorts.   "
81866|NCT02214420|"     Prior trials have shown that many G1 CHC patients are ineligible or intolerant to PEG-based     regimens due to prior severe side effects, worsening of cytopenias, exacerbation of     underlying psychiatric disorders, or autoimmune disorders. These patients will not be     candidates for treatment with the approvals of SMV and SOF in early 2014 due to the     combination with PEG-regimens. Results of the COSMOS study suggest that these patients are     likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy,     and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed     in order to confirm this hypothesis.   "
81867|NCT02214407|"     This is a phase III, two-arm, randomized, stratified, multicenter, open-label study with     individual therapeutic benefit aim:      Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced     proliferative Chronic Myelomonocytic Leukemia (CMML)      The primary objective of the study is to compare between the two arms Event-free Survival     (EFS).      Secondary objectives are to compare between both arms:      Overall Survival (OS) Cumulative incidence of AML Overall and Complete Response Rates at 3     and 6 cycles according to IWG 2006 criteria modified for CMML Response duration Toxicity     (hematological and non hematological) Prognostic factors   "
81868|NCT02214394|"     This study involves the use of an experimental device which will measure how much propofol is     present in your exhaled breath during surgery compared to how much is in your blood. The     study results will look at whether the device is as accurate as conventional methods for     measuring propofol levels during surgery.   "
81869|NCT02214381|"     Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or     Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly     non frail primary breast cancer patients with increased risk of relapse.   "
81870|NCT02214368|"     The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV)     bundle strategy compared with a conventional treatment in postoperative patients with ARF.   "
81871|NCT02214342|"     The aim of the present study is to evaluate an innovative virtual reality-based balance     training intervention for improving clinically relevant motor performances (balance and gait)     in people with mild cognitive impairment.      The investigators hypothesize that the virtual reality-based balance training intervention     will improve balance and gait performances in people with mild cognitive impairment compared     to a control group receiving usual care only.   "
81936|NCT02213497|"     Patients with esophageal cancer to be treated with concurrent preoperative proton therapy     along with carboplatin and paclitaxel.   "
82260|NCT02209246|"     The investigators of this study would like to see whether providing feedback to patients     regarding their illness behavior/coping strategies, using online questionnaires, improves     patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128     patients.   "
81872|NCT02214329|"     Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients,     thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy     of a virtual reality game based exercise training for improving postural body sway and gait     in diabetes patients with peripheral neuropathy. The exercise training has been specifically     designed for DPN patients with lost lower extremity joint perception and uses     state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time     joint feedback through an interactive interface on a LCD monitor. The investigators     hypothesize that tailored exercise with real-time visual joint feedback during exercise will     reduce improve balance and gait.   "
81873|NCT02214316|"     Children with concussion may improve with intravenous fluids.   "
81874|NCT02214303|"     The prevalence of allergic diseases, especially airway allergic diseases, has increased     dramatically over the last twenty years all over the world including Lithuania. Allergic     diseases are associated with significantly reduced quality of life and can sometimes cause     death. Allergic diseases have turned into an important economic and social burden and     nowadays take a more and more important place in the health system. Despite all intensive     investigations, the pathogenesis of allergic airway diseases still remains unclear. As     allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important to     investigate not individual cells, but examine various inflammatory cells instead, including     their biological products and possible cellular interactions along the course of allergic     diseases. This research focuses on the cells that are claimed to be important in the     pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell subset     (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell,     eosinophil. This study aims at determining the importance the way the Th9 lymphocytes     perform, the eosinophil's activity, as well as molecular factors affecting these cells has in     the process of prognostication of allergic airway diseases, namely allergic rhinitis and     allergic asthma. An allergen challenge test will be performed in order to define the meaning     of pathogenetic changes. The results of this research may reveal useful information in the     course of allergic diseases and may be valuable when creating strategic principles of     prophylaxis. The findings could be used for prevention and early diagnostics of allergic     diseases and it could also open doors to discovering new and effective treatment.   "
81875|NCT02214290|"     Caffeine is an exceedingly popular and consumed pharmacological agent. Although caffeine is     primarily consumed from coffee and tea beverages, it is also available in other forms such as     sodas, energy drinks, tablets and capsules. Nevertheless, caffeine acutely increases brachial     and aortic systolic blood pressure (BP) and arterial stiffness. Arterial stiffness is an     independent predictor of cardiovascular disease (CVD) and assessed through pulse wave     velocity (PWV). Interestingly, previous studies have proposed that caffeine may increase     aortic BP through increases in aortic PWV and augmentation index (AIx), a measurement of wave     reflection. Yet, these effects were seen in middle-aged adults with treated hypertension and     a wide age range. Therefore, it is imperative to consider that caffeine may cause different     effects in young normotensive individuals than in older adults independently of BP levels.     Importantly, oral supplementation of the amino-acid, L-citrulline has been shown to enhance     the bioavailability of L-arginine levels and nitric oxide (NO) production and, therefore,     improve arterial function. L-citrulline supplementation for 7 days given at 6 g/day has shown     to increase NO levels while improving PWV. Previous studies by our group also demonstrated     that L-citrulline supplementation reduces the BP response to cold exposure; a condition with     an increased vasoconstriction. Therefore, the acute effects of caffeine on central and     peripheral PWV and BP in healthy young men are yet to be fully evaluated. We hypothesized     that acute caffeine intake would increase peripheral and aortic BP and PWV and that     L-citrulline supplementation would attenuate the effects induced by acute caffeine ingestion.   "
81876|NCT02214277|"     The Sentinel System will be a safe and effective method for capturing and removing embolic     material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce     the ischemic burden in the cerebral anterior circulation.   "
81877|NCT02214264|"     The purpose of this study is to evaluate and compare the effectiveness of several brief     trainings based on contemplative practices and positive psychology to buffer against the     negative effects that acute stress has on behavior and cognitive abilities. The investigators     hypothesize that training will buffer against negative effects of acute stress.   "
81878|NCT02214251|"     We aim to investigate the higher level mechanism of gait disorders in PD patients by     ambulatory recording of electroencephalographic (EEG) and leg electromyographic (EMG) signals     during unconstrained walking. Independent component analysis will be conducted for signal     analysis. The connectivity among different brain regions will also be investigated. The PD     patients received deep brain stimulation will be recruited for the study. The local field     potentials recorded from sub-thalamic nuclei and/or PPN will be recorded concomitantly with     EEG and leg EMG signals during unconstrained walking in PD patients to assess the roles of     these deep structures in ambulation and their functional connectivity with other brain     regions during walking.   "
81879|NCT02214238|"     This study will test the hypothesis that the modified positive airway pressure (PAP) device     for OSA will be no worse than a market released product in terms of its treatment efficacy,     comfort and patient compliance. Patients will have their treatment pressure titrated using     polysomnography (PSG) in the sleep laboratory, and then in a random order will spend     additional time undergoing PSG using both devices, and using both devices at home for 3     weeks. Data will be collected from the PSG studies, device downloads, independent     pressure-flow loggers, and custom questionnaires.   "
81880|NCT02214225|"     This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,     inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015     trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the     alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.   "
81948|NCT02213328|"     Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral     (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure     prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study     is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a     comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of     age.   "
81881|NCT02214212|"     This study proposes to investigate how well Bright White Light Therapy will work in the acute     inpatient rehabilitation units for people whom have experienced a traumatic brain injury for     the purpose of treating sleep disruption. Participants will be assessed based on sleep     efficiency, thinking abilities, therapy participation, and perception of fatigue/sleepiness.     In previous studies dim red light has not had the same effects on function as bright white     light, and will be chosen for use as a placebo. Each subject will be randomized to receive 30     minutes of either Bright White Light Therapy or Red Light Treatment each morning for 10 days.      To measure the effect of this treatment, the investigators will measure the each participants     sleep daily by using an actigraph watch. This watch will record movement continuously. The     investigators will also measure the subjects' report of how well they slept, whether fatigue     is present, and how attentive they are before and after treatment.      Research Hypothesis:      In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning     Bright White Light with a comparison group exposed to Red Light in an acute inpatient     rehabilitation setting.   "
81882|NCT02214199|"     The objective of this protocol is to compare degree of improvement can be achieved in     patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic     spine versus home exercises.   "
81883|NCT02214186|"     Introduction: Pre-eclampsia is a multifactorial syndrome which occurs in hypertension and     proteinuria in pregnant women over 20 weeks gestation. It is the leading cause of maternal     complications such as pulmonary edema, which occurs in about 3% of severe preeclamptic having     as one of the causes volume overload. Anesthetic procedures are frequent in this population,     with replacement with crystalloid of the duct during cesarean section under spinal anesthesia     for combat hypotension and hypovolemia manifested by oliguria. However, as water therapy have     antagonistic effects on cardiopulmonary and renal systems is no doubt as to the benefits     compared to conventional or restrictive pattern of fluid therapy on renal function.     Objective: To compare the renal function of patients with severe preeclampsia who received     restrictive fluid therapy during caesarean section, as well as evaluating the use of cystatin     C and Neutrophil gelatinase-associated lipocalin (NGAL) as a predictor of renal damage in     this population. Hypothesis: Intraoperative fluid restriction did not influence renal     function of patients with severe preeclampsia undergoing cesarean section under spinal     anesthesia.   "
81885|NCT02214160|"     This open-label long-term safety and efficacy study will provide an opportunity for LC-FAOD     patients to be treated with UX007 for up to 5 years or until market approval, whichever     occurs first, under a single standardized protocol. The subjects may have participated in     other studies or treatment programs with UX007/triheptanoin but would be consolidated into     one program for long-term maintenance and consistent safety monitoring. The study is designed     to obtain long-term safety information and evaluate maintenance of efficacy in a diverse     LC-FAOD population.   "
81886|NCT02214147|"     The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment     on the single-dose pharmacokinetics of alisertib in adult participants with cancer.   "
81887|NCT02214134|"     SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the     molecular characteristics of their disease. The thoracic tumors include lung cancer,     malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular     characteristics are identified, there might be the possibility to offer these patients access     to targeted clinical trials.   "
81888|NCT02214121|"     The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and     pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of     twice-daily treatment in paediatric patients with sickle cell disease   "
81889|NCT02214108|"     The purpose of this study is to determine the effect of interactive video game in management     of overweight in children. The investigators will evaluate the effect of product versus     standard physical activity.   "
81890|NCT02214095|"     This study is the first evidence based work evaluated the systemic use of glucosamine as an     adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of     glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of     patients with moderate to advanced chronic periodontitis   "
81891|NCT02214082|"     Study intends to determine if there is any difference in the occurrence of major adverse     cardiology events in patients discharged on the same day as their elective cardiac     angioplasty or discharged one day after their angioplasty.      Hypothesize that same day discharge is as safe as a day later discharge.   "
81892|NCT02214069|"     The purpose of this study is to examine whether patients can use the AliveCor case to record     their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm   "
81893|NCT02214056|"     The main objective of this study is to assess the feasibility of standardized screening for     comorbidities among patients with one or more of three chronic diseases (diabetes, COPD,     atherosclerosis) by a mobile unit at times and localities under-served by health actors.   "
81894|NCT02214043|"     There are no special clinical characteristics of acute pulmonary embolism in Chinese     population.   "
81895|NCT02214030|"     This study was performed to evaluate the safety and efficacy of a locally designed Assiut     Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices     have been developed thorough the past decades without being strongly implemented in the     catheterization laboratory. Their limited adoption reflects concerns of high cost and     conflicting data regarding their safety   "
81896|NCT02214017|"     Progress in technology has made telemedicine-based solutions with video consultations     available in the management and treatment of chronic diseases like diabetes, heart failure     and lung insufficiency at home. However, no direct comparisons on health outcomes of     telemedicine using video consultations versus usual outpatient treatment are available.      We wanted to implement a model of telemedicine and to evaluate health indicators in type 2     diabetes patients treated by video consultations or the standard outpatient treatment   "
81901|NCT02213952|"     INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all     the assistance levels, and they have big repercussion referring to individual, social and     labour levels, supposing a big consumption of human and material resources.The cure with     autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a     decrease in the cicatrization time comparing to conventional methods in hospital levels,     which becomes interesting contrasting its efficacy in primary care.      AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers,     comparing to the conventional treatment ( cure with humid environment), in primary care     patients with chronic venous insufficiency in C-6 degree (CEAP classification).      DESIGN: A study will be executed, which will consist in a randomized clinical test,     multicentered, in parallel groups and opened. 150 patients suffering of venous vascular     ulcers will be studied, who will be between the age of 40-100 years old, and who will be     attached to 10 health centers. Variables for the identification, following, result and     patient profile have been defined. Emphasize the variables of ulcer area decreasing, CIVIQ     index, % one cure per week.   "
81902|NCT02213939|"     Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma     and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can     cause a systemic inflammatory response syndrome (SIRS) which is associated with increased     morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a     potential benefit for cardiac surgery patients.      The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with     the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the     investigators conduct this prospective, observational pilot study to determine the clinical     impact of the use of a cytokine adsorbing circuit during CBP.   "
81903|NCT02213926|"     The purpose of this study is to characterize the safety and efficacy profile of ACP-196     (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).   "
81938|NCT02213471|"     Effective communication between physician and patient is fundamental to effective care. The     recent introduction of electronic patient on-line portals has the potential to change the     communication landscape. The investigators surveyed patients to assess their preferred     modality for biopsy notification at 3 institutions with differing patient access to on-line     portals, to ascertain what patient preferences are currently and if it has changed from     historical preferences. Our hypothesis is that as patients become more familiar with ln-line     portals, their preferences will likely reflect familiarity with this modality.   "
90542|NCT02100956|"     The purpose of the study is to determine the effect of oxytocin given into the spinal fluid     on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic     neuropathic pain.   "
81904|NCT02213913|"     This phase I/II trial studies the side effects and best dose of lenalidomide when given     together with combination chemotherapy and to see how well they work in treating patients     with v-myc myelocytomatosis viral oncogene homolog (avian) (MYC)-associated B-cell lymphomas.     Lenalidomide may stop the growth of B-cell lymphomas by blocking the growth of new blood     vessels necessary for cancer growth and by blocking some of the enzymes needed for cell     growth. Biological therapies, such as lenalidomide, use substances made from living organisms     that may stimulate or suppress the immune system in different ways and stop cancer cells from     growing. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate,     doxorubicin hydrochloride, cyclophosphamide, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in     different ways by targeting certain cells. Giving lenalidomide together with combination     chemotherapy may be an effective treatment in patients with B-cell lymphoma.   "
81905|NCT02213900|"     The purpose of this study is to investigate the effectiveness of a preventative low-dose of     Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or     thoracotomy.      Delirium is state of severe confusion and some symptoms include:        -  Cannot think clearly        -  Have trouble paying attention        -  Have a hard time understanding what is going on around them        -  May see or hear things that are not there. These things seem very real to them.   "
81906|NCT02213887|"     The purpose of this 9-day study is to determine if:        1. Pantoprazole modifies the steady-state plasma concentrations of orally administered          psychotropic medications including valproic acid, lithium, and second-generation          antipsychotics (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine,          paliperidone, quetiapine, risperidone, ziprasidone)        2. Serum gastrin levels change within a week of starting or stopping pantoprazole   "
81907|NCT02213874|"     The purpose of this research is to understand the relationship between trust in the health     care system and choice of contraception during the postpartum period among pregnant women     receiving prenatal care.      Research subjects will complete a questionnaire at enrollment and between delivery and within     5 days of hospital discharge.      A chart review will also be completed to gather use of a birth control method at the six week     postpartum visit as well as pertinent medical diagnoses and recorded data such as height,     weight, body mass index, and contraceptive plan as documented in the postpartum medical     chart.   "
81908|NCT02213861|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE     administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma     (CTCL).   "
81909|NCT02213848|"     The purpose of this study is to evaluate the effect of calcium chloride against residual     neuromuscular blockade at the end of general anesthesia   "
81910|NCT02213835|"     The aim of this study is to determine the tolerability and potential efficacy of dietary     therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with Crohn's disease     (CD) and Ulcerative Colitis (UC). This is a single center, open labelled study designed to     determine tolerability, preliminary safety and potential efficacy in pediatric patients with     CD and UC. The study patients will be recruited from Seattle Children's GI clinic. the     investigators will enroll 10 patients with mild to moderate CD (defined as PCDAI score of     10-29) or Ulcerative colitis (PUCAI 10-60) ages 8 to 21 years. Each patient will be in the     study for approximately 12 weeks.   "
81921|NCT02213692|"     Blood loss during liver resection significantly associates with short term operative outcome.     The median blood loss during partial liver resection is 700-1200ml in high-volume centers.     Conventional method (crush-clamp) has been a standard technique for liver transection.     Technique advances related to liver transection have contributed to reduction in blood loss.     Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use.     A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased     operative time, blood loss and transfusion requirement, and an increased incidence of     postoperative bile leakage. However, no randomized study has compared the difference between     liver resection using traditional technology and harmonic Scalpel. The objective of this     prospective randomized study is to compare the safety and efficacy of liver resection using     the harmonic scalpel device with the crush-clamp technique in respect to blood loss, liver     transection time, hepatic hilum clamping time, hospital stay and postoperative complications.   "
81911|NCT02213822|"     The purpose of this study is to discover genetic changes associated with different cancers.     With the information from this study the investigators hope to provide better ways to     prevent, detect and treat many cancers.      Many diseases can result from changes in a person's genetic material that causes cells to not     work properly. Currently, researchers and doctors know some of the genetic changes that can     cause disease, but they do not know all of the genetic changes that can cause disease.      This project is designed to identify genetic changes that can cause cancer in humans.     Specimens will be collected from a scheduled diagnostic or routine (i.e. blood draw for     counts) procedure and may include samples from the tissue itself (surgery), bone marrow,     blood, saliva, urine, spinal fluid, sputum, joint fluid, seminal fluid, ascites (a fluid that     fills up in the abdomen), and/or pleural fluid (fluid in the lung cavity), to either confirm     the diagnosis of cancer or to help to decide how best to treat cancer or other illness.     Additionally archived tissue may be analyzed. Samples may be stored for future use in later     experiments. The Department of Pathology at Rhode Island Hospital will store the samples.      Information from the medical record, such as responses to treatments or family history of     cancer, will be collected.   "
81939|NCT02213458|"     This is a 3 year clinical trial evaluating the benefits of a program that supports model care     for patients with dementia and their family caregivers. Subjects will be recruited from     several sites in San Francisco. Subjects determined to be eligible will be consented and     randomized into one of two groups. Two thirds of patients will be enrolled into Navigated     Care that provides them with assistance in meeting important benchmarks in their care, for     example completion of legal and financial planning and strategies for minimizing caregiver     burden. One third of patients will be enrolled to a control group, entitled Survey of Care.     Outcomes include quality of life, health care utilization, caregiver burden, and satisfaction     with care.   "
81912|NCT02213809|"     Background:      COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most     patients with COPD are discovered and treated in primary health care. Co-morbidity with heart     disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to     diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most     important factor for decelerating the progress of COPD. In addition, medication and     rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown     poor quality of primary health care provided to patients with COPD.      As general practitioners often deal with multiple medical problems and patients' motivation     when diagnosing and treating COPD we hypothesize that case method education (see description     under intervention) in COPD has better effect than traditional education (see description     under intervention).This study aims to examine the effect of case method education on (1)     learning in COPD among general practitioners and on (2) health in their patients with COPD.      Method:      Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be     randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs)     in COPD for their general practitioners. The educations will be held during two times (two     hours each) within a time range of three months, covering examination and treatment of     patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random     sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will     fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as     well as questions about medication, exacerbations and other chronic diseases. The     questionnaire will be sent to the patients 1-2 months before the education and 18 months     after the education. Differences in assessments in the questionnaire before and after the     education will be compared between the patients listed at the PHCCs that have received case     method education vs. traditional education. In addition, general practitioners     (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12     months after the education, covering the learning outcomes in order to study differences in     learning between the two intervention groups.   "
81913|NCT02213796|"     This is a prospective, noncomparative study to assess the pharmacodynamics of meropenem     during early phase of severe sepsis and septic shock in critically ill patients in an     intensive care unit.      Clinical and laboratory data such as age,sex, body weight, electrolyte, vital signs, APACHE     II score, SOFA score, BUN, Cr and blood culture will be collected.      Twelve patients will be enrolled in this study. Meropenem pharmacokinetic will be carried out     during the first and second dose after 1g meropenem administration. Blood samples     (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.25,     0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 8, 8.5, 9, 9.5, 10, 12, 14 and 16 h.      Meropenem assays will be performed by modified method of Ozkan et al. (Biomed. Chromatogr.,     2001).      The pharmacokinetics of meropenem will be modelled from concentration-time profile using     compartmental model. Monte Carlo simulation to assess PK/PD index as 40% and 100% T>MIC will     be conducted and the results will be reported as % PTA (Probability Target Attainment) and     %CFR (Cumulative Faction Response)   "
81914|NCT02213783|"     This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g     every 6 h of imipenem in twelve patients with febrile neutropenia following administration by     a 4 h infusion or bolus injection.      Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte     Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA     (Probability Target Attainment) and %CFR (Cumulative Faction Response.   "
81915|NCT02213770|"     High-intensity training (HIT) has repeatedly been documented to have superior positive     effects compared to moderate exercise in patients with coronary heart disease and heart     failure. Since heart transplant recipients (HTx), have a denervated heart with different     respond to exercise, HIT has previously not been introduced among these patients.     Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found     that this form of exercise also was highly effective and safe in long term HTx with     clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and     even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we     ask the following questions in this follow-up study:        1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study          period continue during long term follow up (5 years)?        2. Is the intervention group more physical active after HIT compared to the control group?   "
81916|NCT02213757|"     The purpose of this study is to determine if vaginal estrogen use is associated with     resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The     hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will     have higher rates of resolution of hematuria after treatment course with vaginal conjugated     equine estrogen cream compared to placebo cream   "
81917|NCT02213744|"     This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The     trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the     chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic     HER2-positive breast cancer patients. Patients may not have been previously treated with an     anthracycline in any setting. Patients must have received prior treatment with trastuzumab in     any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the     metastatic or locally advanced setting, have either progressed or are intolerant to     pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12     months of pertuzumab treatment in the neoadjuvant or adjuvant setting.   "
81918|NCT02213731|"     The purpose of this clinical study is to assess the single procedure outcomes of using     cryoballoon ablation without additional empirical lesions and/or complex fractionated     electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year     from first diagnosis of persistent AF).   "
81919|NCT02213718|"     This study is to assess the effect of desflurane on myocardial function in patents who     underwent coronary artery bypass grafting.   "
81934|NCT02213523|"     This is a proof of concept study that evaluates the response to oxidative stress in healthy     men after taking plant concentrates.   "
81922|NCT02213679|"     Chronic fatigue syndrome (CFS) is a debilitating condition of unknown etiology. Recent     studies have shown that CFS is associated with impaired cellular energetics and low levels of     phosphocreatine. Since guanidinoacetic acid (GAA) acts as a highly bioavailable precursor of     creatine it may provide an ideal dietary supplement to facilitate treatment and perhaps     prevention of CFS. The overall hypothesis to be evaluated is that medium-term supplementation     with GAA will improve clinical outcomes in well-defined adult CFS patients via augmented     provision of creatine. Specific aims: (1) To determine the effects of GAA on CFS     symptomatology using a fatigue severity inventory, soreness of locomotive apparatus scales,     and a health-related quality of life survey; (2) To determine the effect of GAA on creatine     metabolism using laboratory studies and magnetic resonance spectroscopy; (3) To characterize     the physiological effects of GAA on work capacity via actigraphy and exercise performance     tests; and (4); To determine the prevalence of subjectively reported side-effects and     biochemical adverse events associated with GAA intervention.   "
81923|NCT02213666|"     The presence of intracardiac thrombi and their propensity for systemic embolism is a major     concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing     cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the clinical     gold standard imaging modality for visualization of the right atrial appendage (RAA) and left     atrial appendage (LAA) for detection of thrombi as well as risk factors associated with     thrombus formation, including spontaneous echo contrast and low LAA velocity. However, TEE is     a moderately invasive procedure that incurs additional risk, cost, and patient discomfort. In     addition, thrombus detection via TEE may be ambiguous, and another tool capable of confirming     uncertain TEE findings is desirable. This is particularly crucial in cases when adequate LAA     imaging cannot be acquired or if TEE is clinically contraindicated, requiring alternative     imaging modalities that can visualize these structures.      Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is     routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture     and periprocedural catheter visualization. A majority of imaging acquired during AF ablation     is performed with the ICE catheter in the right atrium (RA). However, these standard views     are often unable to provide sufficient visualization of the LAA structure due to the     relatively long distance between the ICE catheter and LAA.      Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization of     the LAA over other locations by reducing the anatomic distance between the imaging catheter     and structure of interest. Recent retrospective studies have confirmed improved assessment of     the LAA with ICE imaging from the PA and equivocal sensitivity and specificity when compared     with TEE for evaluation of LAA thrombus. However, these studies did not systematically     evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA.      Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE     findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is     required. We hypothesize that this prospective and blinded study will confirm ICE as     non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of     thrombi.   "
81924|NCT02213653|"     Anemia in patients with cancer is a common problem associated with an impaired quality of     life.      Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin     levels in 40-70% of patients and decreased transfusion requirements.      Absolute or functional iron deficiency is also common with about 30% of cancer patients with     all histologies combined iron deficiency and anemia.      Several studies have shown the benefits of the combination of intravenous iron to     erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the     investigators knowledge, has not been specifically performed on a population of patients with     functional iron deficiency.      In addition, in clinical practice, this association is not carried out in particular because     there is no dosage or consensus sequence for the administration of iron associated with ESAs.   "
81925|NCT02213640|"     Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral     neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to     pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses     induce a shift to the right visual field for improving symptoms in short term.      Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency     resulting from stroke with encouraging results. The hypothesis of the study is to evaluate     the usefulness of brain stimulation as an adjunctive intervention to optimize and increase     the rehabilitation of unilateral neglect to long-term.      Thus, the main objective is to evaluate the effectiveness of standard treatment with     prismatic adaptation with anodal tDCS or sham tDCS.   "
81926|NCT02213627|"     The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin     administration) is effective in a controlled ovarian stimulation protocol in oocyte donors     compared to daily gonadotropin administration (recombinant FSH or HP-hMG)   "
81927|NCT02213614|"     The word lithium frequently conjures images of catatonic psychiatric patients and side     effects so severe that premature death is commonplace. But naturally occurring lithium is a     far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an     essential mineral for maintaining physical and mental health. When exposure is low, suicide     rates, mental illness and violent crime increase   "
81928|NCT02213601|"     The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative     to a wait-list control (WLC) condition, for improving psychological functioning and     health-related quality of life in depressed postpartum women. It was hypothesized that the     yoga intervention would be significantly more efficacious than the wait-list control     condition in reducing symptoms of depression and anxiety, and improving health-related     quality of life, at the end of the 8-week yoga intervention.   "
81929|NCT02213588|"     This study evaluates the response to oxidative stress in healthy men and women after taking a     blend of plant concentrate.   "
81930|NCT02213575|"     This study is a mechanistic study that will enroll 9 subjects who are participating in     NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that     minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic     hypertensive individuals) to test whether the antihypertensive effect of minocycline is     associated with a decrease in activated microglia in central nervous system autonomic regions     as evidenced by changes in PET and MRI imaging.   "
81931|NCT02213562|"     The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum     flower oil in suppressing serum uric acid.   "
81932|NCT02213549|"     This study is designed to evaluate the effect of ume paste and ginger powder on glucose     metabolism in prediabetic subjects.   "
81933|NCT02213536|"     To investigate the use of a scalp sparing technique of radiotherapy treatment designed to     treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy     result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and     re-growth similar and slow.      It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will     reduce hair loss and increase the speed and evenness of re-growth.   "
81937|NCT02213484|"     The primary objective of this study is to determine whether specific patterns of circulating     micro-ribonucleic acids (miRNAs) are associated with aortic aneurysm and dissection in     patients with hereditary aortopathy syndromes. The most common of these syndromes is Marfan     Syndrome (MFS), but several other recognized aortopathy syndromes are well characterized. The     investigators propose the use of a simple blood test, from which miRNA profiles can be     measured in individuals with aortopathy syndromes to be compared with miRNAs observed in a     control population that has no known predisposition for aortic disease. The investigators     hypothesize that microRNA profiles in individuals with Marfan syndrome, and related     disorders, will be distinct from those seen in a control group. The investigators predict     that up- or down-regulation of certain miRNAs will correlate with the presence and severity     of aortic aneurysm, responses to medical therapy, and ultimately could be used to determine     when an individual may be at risk of dissection.   "
81940|NCT02213432|"     The purpose of this study is to determine the timing of influenza vaccination to induce     higher antibody response in adult patients with non-hematologic malignancies receiving     scheduled cytotoxic chemotherapy.   "
81941|NCT02213419|"     Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in     abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant.     The diagnosing specific type of cystic lesion is limited in spite of recent advances of     diagnostic modalities. Surgical resection is generally recommended for malignant and     potentially malignant lesions. However, surgical resection has significant morbidity and     sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of     the pancreas reported that complete resolution was achieved in only one-third of patients.     Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.      The purpose of this study is the double ethanol lavage is a safe and effective method for     treatment in those with the indeterminate pancreas cysts.   "
81942|NCT02213406|"     This project will examine neuronal and sensory fat perception. Our hypothesis is that     subjects being either hypersensitive or hyposensitive for fat will show different brain     activities. Therefore the investigators will conduct functional magnetic resonance imaging     (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.   "
81943|NCT02213393|"     The objective is to study the effectiveness of supplementing a standard hospital and 12-week     home menu with protein-enriched Cater with Care products in reaching a protein intake of     1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in     elderly patients.   "
81944|NCT02213380|"     The purpose of this study is evaluate postoperative delirium after general anesthesia and     regional anesthesia in elderly patients undergoing hip fracture surgery. Our research     hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of     postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient     and reduce healthcare costs associated with postoperative delirium. (3) Postoperative     delirium may result in poor long-term functional outcomes.   "
81945|NCT02213367|"     Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and     chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the     population suffers from the disease. Although all age groups can be affected, the peak     incidence is seen between 20 and 40 years of age. The duration of the disease is generally     several years but is likely to be longer in more severe cases, cases with concurrent     angioedema, in combination with physical urticaria or with a positive autologous serum skin     test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep     deprivation and psychiatric comorbidity being frequent. It also has a large impact on society     in terms of direct and indirect health care costs as well as reduced performance at work and     in private life.   "
81946|NCT02213354|"     This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males     and females, 65 years of age and older, who are in good health and meet all eligibility     criteria. This clinical trial is designed to assess the safety, reactogenicity, and     immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by     Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or     15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and     Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and     immunogenicity data will be collected at standard time points with safety follow-up to     continue through one year post dose 2. Study Duration is approximately 30 months and Subject     Participation is approximately 18 months. The primary objectives are to (1) assess the safety     and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an     MF59-adjuv   "
81947|NCT02213341|"     The purpose of this study is to assess the responses in the immune system of infants after     they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators     will do this by studying the immune cells and allergy responses in the blood prior to and     after receipt of the third DTaP vaccine.   "
81949|NCT02213315|"     A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of     single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.   "
81950|NCT02213302|"     Preoperative anxiety is a subjective and painful experience and may have adverse     psychological consequences and complicate anesthetic management. The aim of the study is to     show the effect of premedication by midazolam on preoperative anxiety assessed by a visual     analog scale and by measuring salivary cortisol levels. This study was a monocentric,     prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to     79 years, to undergo elective surgery under general anesthesia with tracheal intubation must     be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome     is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the     reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of     respiratory and hemodynamic adverse effects of midazolam.   "
81951|NCT02213289|"     The purpose of this study is to determine if doctors can use the results of special tests of     subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a     specific drug that is targeted to work against that abnormality (called molecular profiling)     and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it     is given with standard chemotherapy.   "
81952|NCT02213276|"     Diabetes is associated with an increased risk of bone fractures, but current predictors of     bone fracture seem to underestimate this risk. It is commonly known that increased levels of     certain biochemical bone markers predict low-energy fractures, but the pattern of these     markers in diabetics still show heterogeneity and inconsistency. Part of the pathology of     diabetes is a high blood glucose level, and this can potentially influence bone turnover and     thereby bone markers. Chronic inflammation in patients with inflammatory bowel disease is     shown to increase bone resorption, and the same may be the case in diabetics. The purpose of     this project is to investigate whether glucose has a direct effect on bone markers or an     indirect effect through intestinal hormones or inflammatory processes.   "
81953|NCT02213263|"     This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in     patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to     be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall     Response Rate, is similar to that of rituximab-EU.   "
81954|NCT02213250|"     The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK     study and to support the registration in China.   "
81955|NCT02213237|"     It has always been a real challenge to treat sepsis in critically ill patients. The mortality     is as high as 20％ in patients with severe sepsis and 46％ with septic shock develops. Early     diagnosis and early treatment are the principles. Along with appropriate resuscitation,     judicious and thoughtful intravenous antibiotic therapy is the critical determinant of     survival in sepsis and septic shock given that ineffective initial therapy worsens the     outcome. Blood culture and subsequent susceptibility testing are the gold standard for     microbiological diagnosis to direct the optimal use of antibiotic. However, this conventional     approach usually takes 5-7 days to wait for the final report. Positive results were reported     in only 30% of patients with sepsis and 50 to 60% septic shock. Moreover, the very low     bacteria level in blood and prior use of antibiotics may prevent pathogen growth.     Surface-enhanced Raman scattering (SERS) is a novel spectroscopy technique based on Raman     scattering and localized surface plasma resonance (LSPR), which results in strongly enhanced     Raman signals derived from molecules attached to nanometre-sized gold (Au) and silver (Ag)     structures. SERS provides the structural information of biomedical molecules with     ultra-sensitive characterization down to single molecular level in fast and non-destructive     manner. The clinical application of SERS in sepsis will first help to recognize pathogens as     well as their specific drug sensitivity, and then optimally guide the initial antibiotics     usage. Plasma from twenty blood culture proven Gram positive, negative and Candida cases will     separately subject to metabolomics profiling and bioinformatics analysis to establish each     pathogen metabolites profile. The sensitivity and specificity of SERS and metabolomics in     identifying pathogen and antibiotics-resistant strains will be evaluated. The investigators     expected both techniques to play a crucial role in modern sepsis treatment and bring great     impact on mortality reduction.   "
81956|NCT02213224|"     The aim of this current study was to assess the therapeutic effects of perindopril and     telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic     effects of these two kind of drugs.      This study is a randomized parallel control clinical trial which would be carried out in     Nanfang Hospital, Southern Medical University.      About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan     and amlodipine three groups.   "
81957|NCT02213211|"     Malaria is an important contributor to ill-health experienced by school-children and may have     profound consequences for their learning and educational achievement, and there is a small,     but growing, body of evidence that suggests malaria control can help improve educational     outcomes. In Malawi, school-aged children are estimated to experience 0.59 clinical attacks     of malaria each year, equivalent to 2.1 million attacks among Malawian school-aged children.     To avert this health burden and potential education consequences, Save the Children in     partnership with the Malawian Ministry of Health is providing treatment of symptomatic     malaria cases in schools in southern Malawi, as part of the provision of first aid kits     (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this     intervention, a cluster randomised trial is being conducted among 58 schools in Traditional     Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive     LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination     therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group.     The primary outcome is school attendance, with secondary outcomes of grade repetition, school     drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and anaemia. The     study aims to conduct several quantitative and qualitative assessments to help evaluate the     external validity of the findings.   "
81977|NCT02212951|"     The study is to compare meal time glucose control associated with BIOD-531, a rapidly     absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.   "
81978|NCT02212938|"     To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a     standardised high fat breakfast   "
81979|NCT02212925|"     To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332     CL following administration of multiple rising oral doses over 10 days in patients with type     2 diabetes.   "
81980|NCT02212912|"     The purpose of this study is to evaluate whether a multifaceted quality improvement     intervention can improve the adherent rate of individual and composite of evidence-based     performance measures for patients with acute ischemic stroke within the first 7 days of     symptom onset and reduce the incidence of a new clinical vascular event, disability, and     all-cause mortality at discharge and long term clinical outcome.   "
81958|NCT02213198|"     The cost of serious mental illness (SMI) in the U.S. is $317 billion annually. This     translates to more than $1000 for every man, women, and child in the U.S. Hospitalization and     Emergency Room (ER) visits have the highest costs. Outpatient services are overburdened.     There is a push to get people out of hospitals quickly, while they are still quite ill. These     factors cause patients to be lost in the transition from inpatient to outpatient care. Many     individuals are repeatedly rehospitalized or continue to clog emergency rooms in an attempt     to receive care. The importance of transitional care between inpatient/ER facilities and     outpatient services to prevent this revolving door phenomenon has been continually stressed.     There is little research on the best way to accomplish smooth transition to outpatient care.     We developed a 90-day transitional care clinic (TCC) to address this need. We propose a     randomized treatment outcome study comparing two transitional service packages within our     TCC: a Standard Care package versus an Engagement-Focused package that features a novel     intake procedure and a Shared Decision-Making intervention: Access Group is an intake     procedure designed to address many of the problems of traditional approaches to post-acute     treatment engagement, including failure of patients to reach intake appointments. Shared     Decision-Making (SDM) is a structured approach to provider-patient communication that has     been shown to increase patient involvement in care and improve outcomes. Despite SMI     patients' desire to be more involved in their treatment decisions and promising early     evidence of SDM's effectiveness in SMI, SDM has not been systematically evaluated in     transitional psychiatric care. In the proposed study, patients referred to TCC will be     randomized to either Engagement-focused Care or Standard Care. The relative benefit of these     two approaches will be evaluated in 300 individuals who will be randomized to these two     treatments in a 2:1 ratio. We hypothesize that attendance at appointments, reported     satisfaction, shared decision making and quality of life will be higher for engagement     focused care. The new treatment package is designed to get individuals into treatment quickly     and to teach them how to be good consumers of mental health treatments going forward.   "
81959|NCT02213185|"     The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile     water injections.   "
81960|NCT02213172|"     The purpose of this study is to determine if two different probiotic strains, Lactobacillus     paracasei HA-196 and Bifidobacterium longum R0175, are effective in helping subjects manage     the symptoms of IBS   "
81961|NCT02213159|"     The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will     reduce postoperative morphine consumption and improve postoperative quality of recovery as     compared to morphine in patients undergoing laparoscopic bariatric surgery.   "
82054|NCT02211937|"     Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs.     400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic     (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg     BI 44847 as tablet.   "
82055|NCT02211924|"     Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847     in Japanese healthy volunteers   "
81962|NCT02213146|"     The addition of BioChaperone to already marketed prandial human insulin preparations may     accelerate the onset and shorten the duration of action due to facilitation of the insulin     absorption after subcutaneous injection.      The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in     subjects with type 1 diabetes under a dose of 0.2 U/kg.      This trial is a single center, randomised, double-blinded, three treatment, three-period     cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each     subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a     single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3     separate dosing visits.   "
81963|NCT02213133|"     Open-label, multi-center, single-arm, Phase 2 study of oral selinexor in patients with SCC of     the head and neck (HN-SCC; Cohort 1), lung (L-SCC; Cohort 2), or esophagus (E-SCC; Cohort 3)     who have relapsed or have metastasis following chemotherapy.   "
81964|NCT02213120|"     The VERTIGO study is likely to help determine characteristics of different types of vertigo     in patients presenting in the Ear Nose & Throat (ENT) clinics with complaints of dizziness.     Moreover, it will also help to develop an understanding about the current management     practices of this condition at local level.   "
81965|NCT02213107|"     Determine the effect of enzalutamide and dutasteride on the time to prostatic-specific     antigen level increase in patients age 65 or older.   "
81966|NCT02213094|"     This is an open labeled dose escalation safety study of vitamin B3-amide dietary     supplementation in pregnant women with hypertensive complications of pregnancy. The     investigators will enroll 5 pregnant women at 24-36 weeks' gestation with the diagnosis of     hypertensive complications of pregnancy. If the woman is anticipated to remain undelivered     for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day in a single daily     dose, continuing for two weeks or until delivery, which ever occurs first. Maternal blood     will be collected at baseline and 2 times per week to measure maternal LFTs and study markers     (nicotinamide metabolites, sFlt-1-Soluble fms-like tyrosine kinase-1 and PlGF). The objective     of this dose escalation safety study is to determine the safety of vitamin B3 amide dietary     supplementation during expectant management of hypertensive complications of pregnancy.   "
81967|NCT02213081|"     The aim of this research is to assess the benefit of a medication (ulipristal) for     alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.   "
81968|NCT02213068|"     This study is being done to investigate the impact of changing immunosuppressive medications     from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months     after kidney transplantation. The immune system is the body's defense against infection and     other disease. After transplantation, the body sees the new organ as foreign and tries to     destroy or reject it. Immunosuppressive medications help to prevent the immune system from     attacking the transplanted organ. The primary purpose of this research study is to evaluate     the effects of three (3) different immunosuppressive treatments on rejection in     post-transplant kidney recipients. This study will test whether switching from tacrolimus to     belatacept will improve long-term kidney function.      Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate     mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug     Administration (FDA) to be used after transplant. All of these medications have been     routinely used in kidney recipients here at Northwestern University.      Belatacept (the study drug) has been approved by the FDA for use at the time of transplant.     However, the use of belatacept in this study is considered investigational as it has not been     FDA approved for use beginning at 3 months after transplant.      This study will involve 51 adult kidney transplant recipients at Northwestern.   "
81969|NCT02213055|"     -  To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric          population.        -  To evaluate the safety of LiceMD in a pediatric population.   "
81981|NCT02212899|"     To establish an observational registry for systematic collection of clinical data from     Renaissance-guided spine surgeries.   "
81982|NCT02212886|"     -  This is a phase IIa study in which GA Depot 80 or 40mg is administered as an IM          injection to subjects with RRMS at 4 week intervals for 52 weeks of treatment.        -  The purpose of the study is to assess safety, tolerability, and efficacy of a monthly          long-acting IM injection of 80 or 40mg GA Depot in subjects with RRMS. The study will          include subjects switching from daily or thrice weekly administration of 20 mg or 40mg          respectively of glatiramer acetate (GA, i.e., Copaxone) injection   "
81970|NCT02213042|"     This is a multicenter, open-label, Phase II study in subjects with Human epidermal growth     factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines     of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing     regimen. This study is a post-approval commitment with regulatory authorities. It is designed     with the primary endpoint to evaluate the changes in biomarkers associated with HER family,     immunomodulation, apoptosis, and Adenosine triphosphate binding cassette (ABC) transporters     between the pre-treatment and disease progression biopsy. It is hypothesized that these     changes in biomarkers may modulate resistance mechanisms and thereby alters the response to     subsequent chemotherapy based regimens. Therefore, in addition to the description of the     clinical outcome of Overall response rate, Clinical benefit rate, Progression-free survival     and Overall survival for each arm, Progression-free survival on next-line therapies will be     collected and summarized for each arm. All subjects will receive study treatment until     disease progression, unacceptable toxicity, or subject withdrawal, and after which, will be     followed for subsequent anticancer therapy and disease progression events, and survival. The     primary endpoint of the study will be to evaluate changes in expression of biomarkers     associated with the HER family or receptors and ligands, immunomodulation, apoptosis, and ABC     transports between a pre-treatment biopsy and the disease progression biopsy. This study will     evaluate potential mechanisms to explore the antitumor activity of dual blockade and will     provide a descriptive clinical outcome for subjects treated with Trastuzumab in combination     with Lapatinib or chemotherapy. No formal comparisons between treatment arms will be     undertaken.   "
82056|NCT02211911|"     To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in     breast milk of healthy lactating women after an oral administration of 10 mg once daily over     a period of 8 days.   "
81971|NCT02213029|"     This multi-cohort phase I study is designed to assess the pharmacokinetics (PK) and     pharmacodynamics (PD) of oxytocin and to evaluate epelsiban (GSK557296) potential to reduce     subendometrial contractractility induced by oxytocin in healthy female subjects. Additionally     tissues concentrations of epelsiban will be determined from endometrial tissue biopsies. Data     from this study will inform the identification of the doses of epelsiban to be used in future     in-vitro fertilization (IVF) clinical studies. Expected number of subjects to be randomized     are: Cohort 1- 10 subjects, Cohort 2a- 10 subjects for each epelsiban arm 25 milligrams (mg),     200mg, 5 for placebo, Cohort 2b- 10 subjects per arm with dose to be determined, cohort 3- 6     subjects. Cohorts 1 and 2 will be double blind (sponsor unblinded) placebo controlled     cohorts. Cohort 3 will be an open label cohort, cohort 4 will be a double blind (sponsor     unblinded) placebo controlled cohort.   "
81972|NCT02213016|"     The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in     patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex     (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied     vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active     or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three     months.   "
81973|NCT02213003|"     Current islet transplantation into the portal vein of the liver has shown the unique ability     of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected     group of subjects with Type 1 diabetes. The main limitations of islet transplantation are the     need for systemic immunosuppression to maintain function and the loss of islet function over     time. Additionally, many studies have demonstrated that the current site of transplantation     in the liver is not an ideal site due to several factors. These factors include (1)     significant liver inflammation following islet infusion; (2) potential for life-threatening     procedure-related complications such as bleeding and thrombosis; (3) high levels of     immunosuppressive drugs and GI toxins in the liver contributing to islet toxicity; (4) the     inability to retrieve islets after infusion; and (5) development of graft dysfunction in a     number of recipients of intrahepatic allogeneic and autologous islets. The implantation of     islets into the omentum will allow adequate engraftment of islets onto the omentum and will     lead to comparable or superior functional and clinical outcomes than in the traditional     intrahepatic site.   "
81974|NCT02212990|"     This study aims to conduct a double-blind, placebo-controlled study to assess the effect of     prophylactic antipyretics on the immune responses and rates of fever after inactivated     influenza vaccine (IIV) in children 6 through 47 months of age.      In this study, 160 healthy children, 6 through 47 months of age, including some children at     risk of febrile seizure, will be randomized to one of three different treatment arms.     Children will receive either blinded therapy with prophylactic acetaminophen or placebo     immediately following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV     or open-label ibuprofen every 6 to 8 hours in the 24 hours after receipt of a dose of IIV.     Children will be followed for the occurrence of fever, fussiness, changes in appetite and     sleep patterns, and use of medical services on the day of and for two days following     vaccination. Antibody to influenza antigens contained in the respective 2014-2015 and     2015-2016 vaccines as measured by hemagglutination inhibition (HAI) antibody will be assessed     at baseline and four weeks following vaccination. The proportions of children experiencing     fever, having solicited side effects, using medical services, demonstrating a serologic     response corresponding to seroprotection and seroconversion to each of the IIV antigens will     be determined for groups of children in each of the three treatment arms. Likewise geometric     mean HAI titers (GMTs) and corresponding 95% confidence intervals for each IIV antigen will     be calculated for the three treatment arms. The investigators hope to learn whether or not     prophylactic antipyretics affect the immune response and fever rates following IIV.   "
81975|NCT02212977|"     Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with     stitches in Port a Cath patients, who, as a population, are at increased risk for     complications. All adult patients who present for initial Port a Cath placement during the     recruitment period will be eligible to participate in the study. Subjects will be randomized     to either skin incision closure with standard stitches or closure with skin glue. Time to     complete skin closure and costs of closure will be compared. Patients will be evaluated     approximately one month and three months from the procedure to assess for complications of     wound breakdown or infection, as well as for the appearance of the Port a Cath incision.   "
81976|NCT02212964|"     Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility     maps and well as susceptibility-weighted imaging post processing the investigators     hypothesize that the investigators would be able to distinguish between pseudoprogression and     true progression with the use of an easily implementable sequence on clinical MRI scanners.   "
81983|NCT02212873|"     In order to address and curb the high prevalence of childhood obesity in Malaysia, a     school-based intervention program, MyBFF@school is developed for implementation in all     schools in the country. The program is specific for overweight and obese students and it is     hypothesized that by participating in this program, students will be able to control their     body mass index.   "
81984|NCT02212860|"     Radiation therapy after surgery to remove breast cancer improves control of the breast     cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation     to the entire breast.      This clinical trial will evaluate the effectiveness of conformal radiation therapy delivered     only to the area in the breast where the lumpectomy will be performed.      This study will determine if radiation therapy delivered in this manner will prevent the     cancer from coming back and eliminate the need for five to six weeks of radiation.      The study will also gather information about the safety and effects (good and bad) this     radiation has, and on patient satisfaction with the appearance of the breast.   "
82010|NCT02212509|"     The aims of the cohort study is to describe the rates of 30-day surgical complication,     functional decline, frailty and one-year mortality for patients experienced cardiac surgery     and to delineate the trajectory of functional capacity 1 year after surgery for the patients.     It also will test whether the trajectory of functional varied significantly according to     delirium status and its type over the follow-up period and examine the patients' postsurgical     actual caloric/protein/fluid intake in relation to the functional capacity within 3 months     after surgery as well as evaluate whether activity levels, dietary diversity, and depressive     symptoms at 3,6, and 12 months affect patient outcome.   "
81985|NCT02212847|"     Spatial orientation is achieved through central integration of various sensory inputs and     prior knowledge in a statistically optimal way based on the reliability of the different     signals. When upright, the subjective visual vertical (SVV) is accurate and precise in     healthy human subjects. However, when roll-tilted, both systematic physiologic, roll-angle     dependent errors (termed A- und E-effect) and a decrease in precision of SVV estimates have     been described. In case of a sudden unilateral vestibular deficit (UVD) a significant     imbalance between the two vestibular organs occurs at the level of the vestibular nuclei,     disrupting the percept of vertical. The most frequent cause for such a unilateral vestibular     deficit is an inflammation of the vestibular nerve by viral infection, termed vestibular     neuritis (VN). While in the acute stage these patients are usually immobilized due to the     severity of symptoms, recovery is overall good and most patients return to their daily     activities within a few weeks. Central compensation is considered the most important     contributor to recovery in these patients, while recovery of the damaged vestibular nerve     occurs only in a minority of cases. While acute VN presents with sudden UVD, bilateral     vestibular deficits (BVD) typically evolve more slowly and re-sult in distinct complaints.      The percept of vertical can be quantified by assessing the subjective visual vertical or SVV,     which is usually done by letting subjects adjust a luminous line along perceived direction of     gravity. Modifications of this paradigm which are independent from retinal input are e.g.     adjustments of a rod along perceived vertical in complete darkness (termed subjective haptic     vertical or SHV) and self-alignments along perceived vertical (subjective postural vertical     or SPV) and perceived horizontal (subjective postural horizontal or SPH) in complete     darkness. Previous research has proposed no unified percept of vertical as errors assessed in     different domains (visual, haptic, postural) were diverging in patients with acute UVD. While     errors were profound for the SVV, the SPV remained accurate.      Here the investigators aim to quantify verticality perception in patients with either acute     or chronic UVD and patients with BVD both in upright and roll-tilted positions. Specifically,     the investigators will use different paradigms to address the ques-tion whether there is a     unified percept of vertical and how a bias in this percept changes over time.   "
81986|NCT02212834|"     The purpose of this study is to determine the effectiveness of surveillance breast MRI     compared to mammography alone in women with a personal history of breast cancer   "
81987|NCT02212821|"     The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on     hunger, and the brain mechanism lying behind it.   "
81988|NCT02212808|"     The Infectious Diseases Society of America (IDSA) guidelines recommend two core strategies     for Antibiotic Stewardship (AS): 1) antimicrobial restriction and preauthorization and 2)     prospective audit with intervention and feedback. Community hospitals have limited or no     resources and staff dedicated to AS. Thus, understanding which of the core strategies is most     feasible and effective in this practice setting would assist in appropriate allocation of     limited resources. The purpose of this study is to evaluate the feasibility of implementing     antimicrobial restriction and preauthorization vs. post antibiotic prescription review in     resource-limited community hospitals.   "
81989|NCT02212795|"     Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of     Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy     volunteer   "
81990|NCT02212782|"     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of     Linagliptin after oral administration in healthy male volunteer.   "
81991|NCT02212769|"     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Losartan     after oral administration in healthy male volunteer   "
81992|NCT02212756|"     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of     Metformin after oral administration in healthy male volunteer   "
81993|NCT02212730|"     This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab     (MK-3475) on tumors of participants with renal cell cancer (RCC). The primary hypotheses are     that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that     pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic     infiltration in at least 30% of participants with RCC.   "
81994|NCT02212717|"     Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for     surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in     these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in     treatment of this condition has been demonstrated but how the two procedures compare to one     another is uncertain.      The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk     patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize     that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.   "
81995|NCT02212704|"     The purpose of this study is to evaluate the relative contribution of head- and trunk-based     sensory systems to internal estimates of direction of gravity in healthy human subjects. To     implement this assessment experimentally, the investigators will use a motor-driven     3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°)     or aligned with the trunk. The investigators will then obtain measurements of the subjective     visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis     will be driven by a state-of-the art Bayesian integration model. The investigators     hypothesize that different sensory input signals are combined in a statistically optimal     fashion.   "
81996|NCT02212691|"     The purpose of this research is to use non-invasive imaging technologies to study how the     human brain processes pain. The investigators will use contact heat to induce pain and record     data scalp EEG and functional magnetic resonance imaging (fMRI). What the investigators learn     from this study will help us gain insights in pain management with broad socioeconomic     impacts   "
81997|NCT02212678|"     The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as     therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.   "
81999|NCT02212652|"     VISTA is looking to see if vitamin D supplements before bariatric surgery might improve     vitamin D stores, which may help to prevent some complications like infections.      Who can join this research study?        -  Approved to undergo bariatric surgery—Roux-en-Y Gastric Bypass or Vertical Sleeve          Gastrectomy—at the Johns Hopkins Bayview Medical Center        -  18 to 64 years of age        -  BMI of 35 to 49.9 kg/m2        -  VitD insufficient or deficient prior to having surgery      What will happen if a participant chooses to participate in this research study?        -  The participant will be randomly assigned (by chance) to receive either:        -  Standard care plus vitamin D supplements or        -  Standard care plus a placebo (contains no vitamin D)        -  Either would be provided at no cost to the participant        -  The investigators will ask the participant to complete a survey on the day of surgery          regarding supplement use        -  The investigators will follow the participants medical record through the 12 month          follow up clinic visit.   "
90543|NCT02100943|"     This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the     third trimester of pregnancy and again postpartum.   "
82000|NCT02212639|"     Classic and endemic Kaposi's sarcoma (KS) are lymph angio proliferations associated with     human herpes virus 8 (HHV8) which treatment is poorly codified. Chemotherapies give at best     30-60% of transient responses. While interferon responses are frequent, this drug is often     poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS     represents an ideal model for evaluating new drugs since patients do not receive concomitant     immunosuppressive regimens nor antiviral therapies.      Hypoxia-inducible factor 1(HIF-1 alpha) is a major regulator of solid tumor growth and     therefore a suitable target currently explored in many cancers. Moreover HIF-1 alpha enhances     HHV-8 gene expression in KS and induces lytic replication cycle. Digoxin has anti cancer     effect in vivo through HIF-alpha down regulation in several preclinical tumor models     including KS. The identification of HIF-1 alpha as a key factor in HHV8 replication prompt us     to explore inhibition of HIF-1 alpha by digoxin as a potential therapeutic approach for KS     treatment it has and consequently may down regulate HHV-8 replication in KS. This latter     approach is heightened by recent data suggesting that Digoxin has some efficacy in vitro     against others human herpes virus i.e. Herpes simplex and Cytomegalovirus (8) (9)      In this study the investigators shall evaluate the benefit and safety profile of digoxin in     classic and endemic KS (serum drug concentration of 0.6 to 1.2 ng/ml for patients <75 years     and between 0.5-0.8 ng/ml in patients older than 75 years The participants will take study     drug digoxin, for a total of 6 cycles (4 weeks/cycle).   "
82001|NCT02212626|"     The objective of this study is to evaluate the safety and efficacy of recanalization of acute     and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)   "
82002|NCT02212613|"     The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive     treatment in subjects with Major Depressive Disorder with irritability   "
82003|NCT02212600|"     The proposed project will be a multi-centre, prospective observational study to determine the     prognosis and determinants of functional outcomes of patients with proximal humerus     fractures. Approximately 10 centres will participate in this observational cohort, each     enrolling at least 50 patients over the course of 2 years.   "
82004|NCT02212587|"     The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce     the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of     cystic fibrosis patient.   "
82005|NCT02212574|"     Participants enrolling on this study will receive standard of care chemotherapy for Wnt     positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is     given during radiation therapy.   "
82006|NCT02212561|"     The purpose of this study is to test the safety of selinexor (KPT-330) and to find the     highest dose of selinexor (KPT-330) that can be given safely when it is combined with two     chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase     I and Phase II.      The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can     give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine.      The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) is to     give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that     was found in Phase I to be safe for children with leukemia or MDS. The investigators will     examine the effect of this combination treatment.      PRIMARY OBJECTIVE:        -  Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric          patients with relapsed or refractory hematologic malignancies included acute myeloid          leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia          (MPAL) and myelodysplastic syndrome (MDS).      SECONDARY OBJECTIVES:        -  To characterize the pharmacokinetics of selinexor, when administered in tablet form,          after the first dose and at steady-state, as well as in combination with fludarabine and          cytarabine        -  To estimate the overall response rate of selinexor given with fludarabine and cytarabine          in patients with relapsed or refractory hematologic malignancies   "
82007|NCT02212548|"     This is a Phase I prospective study of 30 patients to determine whether PEG hydrogel     (SpaceOAR) reduces the dose of radiation delivered to the rectum during Image Guided     Intensity Modulated Radiotherapy (IG-IMRT) for prostate cancer, by increasing the space     between the prostate and the rectum.   "
82008|NCT02212535|"     The purpose of this study is to assess the tolerance and efficacy of mobilizing hematopoietic     stem cells after a single injection of plerixafor (0.24mg/kg) in 3 adult patients (or 5, if     results of the first 3 patients are not reproducible) affected by sickle cell disease.   "
82025|NCT02212314|"     The investigators will conduct a pilot study investigating the effectiveness of a     computerized response inhibition training program at reducing the response inhibition     difficulties often seen in children with Williams syndrome ages 10-17. The investigators     hypothesize that after completing the training program, children with Williams syndrome will     show improvement on computerized measures of response inhibition and on parent measures of     impulsivity.   "
82026|NCT02212301|"     This study is comparing two silicone hydrogel contact lenses in a controlled environment for     identification of characteristics associated to vision.   "
82027|NCT02212288|"     To date, oxidative stress in PKU has been evaluated only with fragmented approaches.The aim     of the present study is to investigate oxidative stress in PKU with more comprehensive     methods.The relationship between oxidative stress and metabolic disturbances     (hyperPhenylalaninemia) will also be studied.   "
82009|NCT02212522|"     The aim of this study is to complete the identification of genetic factors (G) and to     undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by     constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G     analysis (whole genome genotyping done once a patient using methods conually updated at     Centre National de Genotype) and innovative E analysis to develop the following long term     objectives :        -  Identify G and E factors influencing the process of remaining beta cells' destruction          during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years          diabetes duration);        -  Identify G factors (pharmacogenomics) of the individual response to insulin using the          effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients          with negative C-peptide and well managed diabetes);        -  Undertake a prospective research of G and E risk factors of death in bed syndrome in          diabetic adolescents;        -  Undertake a prospective research of G and E risk factors of incipient glomerular          microangiopathy (regule measurement of microalbuminuria).   "
82012|NCT02212483|"     Asthma is one of the most prevalent chronic respiratory diseases, with potential     lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases     per year in France, and constitutes a public health problem in our country as in many     countries in the world. The economic burden of asthma is also very high, in terms of health     care, and indirect costs including lost work and lost school days.      A few international and French studies have shown a positive clinical impact of Medical     Indoor Environment Counselors (MIECs) visiting homes of asthma patients, mainly pediatrics.     It has been proposed that MIECs could contribute to reduce patient exposure to many allergens     and irritants, among them, house dust mite allergens, formaldehyde or molds. Most of the     studies that show a significant decrease of hospitalization or visit in an emergency ward for     asthma are monocentric and study the eviction of 1 such identified risk factor. By contrast,     meta-analysis underline that additional studies are needed to evaluate the effectiveness of     these interventions in adults, in a multicentric and controlled manner, with both clinical,     environmental and economical endpoints.   "
82013|NCT02212470|"     The purpose of this study is to evaluate whether the results of drug eluting balloon are     equivalent to the Nitinol stent implantation in the Superficial Femoral Artery.   "
82014|NCT02212457|"     The main purposes for conducting the study are firstly to assess immunological     non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to     healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine     (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give     the flexibility for the national vaccination program by showing the safety and immunogenicity     of MenABCWY administrated according to four different vaccination schedules and additionally     to evaluate a potential benefit of the 3-dose vaccination series.   "
82015|NCT02212444|"     Plantar fasciitis (severe pain in the heel) is a common problem that has a significant impact     on quality of life. There is some evidence to support the use of orthoses and stretches in     the conservative management of plantar fasciitis but current orthotic management may not be     optimal. More prolonged stretching with night splints may achieve better results but such     splints are clinically not well tolerated. Therefore, there is a potential need to apply     prolonged stretching during the day and during dynamic tasks such as walking. This has led to     the development of other rigid and semi-rigid splints that have shown promising results in     small scale clinical trials. There are disadvantages however with the more rigid bracing and     orthoses seen in these types of splints. For example, they are often difficult to accommodate     with a person's available shoes; this can be particularly difficult for women and thus limits     their compliance with the intervention. Further, more rigid bracing can be uncomfortable     during fast walking and running and so limits participation in such activities.      Recently a novel orthotic, a customised dynamic elastomeric fabric orthoses (DEFO), has been     developed. Being made from lycra® based materials the sock-like splint is lightweight and     discrete, allowing it to be accommodated easily into most shoe types and potentially better     tolerated when worn at night compared to currently available splints. Its design further     allows it to be used comfortably during dynamic tasks such as walking and running as     supported by initial anecdotal evidence in athletes. To date there has been no evaluation     into the effectiveness of the DEFO in the general population with plantar fasciitis.      This study will look at the feasibility of conducting a randomised controlled trial into the     use of a DEFO compared to an off-the-shelf orthoses as an adjunct to usual care.   "
82016|NCT02212431|"     The morbidity and mortality associated with Cystic Fibrosis (CF) are the result of chronic     suppurative lung disease. The aggressive use of antibiotics is one of the mainstays of     treatment in CF, however, the problems of multiple drug resistance and adverse reactions are     major clinical issues.      Cysteamine is a licensed drug used in the treatment of cystinosis. In vitro work suggests     that cysteamine has properties of potential benefit in CF. Cysteamine is a potent mucolytic,     it disrupts biofilms, it is antimicrobial, and synergises with other antibiotic agents. CF is     characterised by malabsorption and it is not known whether cysteamine is absorbed in CF,     furthermore it is not known if cysteamine enters the bronchial secretions. It is not possible     to assume that the pharmacokinetics of cysteamine in patients with CF are the same as those     reported for cystinosis.      Objectives: to characterise the pharmacokinetic profile of cysteamine in people with CF, to     ascertain whether cysteamine enters the bronchial secretions and the tolerability of     cysteamine by patients with CF.      Method: a single centre, single group open label investigation of the tolerability and     pharmacokinetics of oral cysteamine (Cystagon) when administered to patients with Cystic     Fibrosis at the dose licensed for use in cystinosis.      Setting: adult CF clinic, Aberdeen Royal Infirmary.      Target population: 12 patients aged ≥18years with CF associated lung disease who are     clinically stable.      Intervention: Oral cysteamine (Cystagon) will be increased from 450mg od to 450mg qds over     three weeks, they will remain on 450mg qds for two weeks.      Assessment: face to face health outcome assessments will be carried out for all participants     at recruitment/baseline, 1, 2, 3, and 5 and 6 weeks. Serial blood cysteamine levels will be     measured in the first 24 hours after the first dose. Sputum cysteamine will be quantified     after two weeks of full dose cysteamine 450mg qds. Disease specific health status (CFQ-R)     will be assessed at baseline and after two weeks of full dose. At each assessment, lung     function (FEV1, FVC), adverse reactions and serious adverse events will be ascertained. Blood     samples will be taken for measurement of haematological and biochemical parameters. Sputum     samples at each assessment will be analysed for microbial load and spinnbarkeit.   "
82723|NCT02203227|"     The purpose of this study is to investigate the efficacy and safety of dietary supplements     (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic     smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.   "
82017|NCT02212418|"     Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic     floor dysfunctions in the postpartum. In the last years it has been extended out of such     medical context but there is a lack of scientific evidence, and the endurability of the     effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a     12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary     incontinence, in women out of the postpartum phase. In addition the investigators looked for     the endurability of its effect.      Methods: The investigators performed a cross-over blinded intervention study of 4 month     duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no     AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2     months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2     months versus AHT.      The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms,     as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired     as adequate.   "
82018|NCT02212405|"     Findings from this study may demonstrate how the insula contributes to reward pathways     involved in addiction. There are three main hypotheses for this trial. The first is that     inhibiting the insula using transcranial magnetic stimulation (TMS) will not cause noticeable     changes of dopamine release in the striatum. The second is that stimulating the insula with     TMS will increase dopamine release in the striatum, and will be visualized on PET imaging as     decreased radiotracer binding. The third hypothesis is that the participants will not     experience major side effects from TMS on the insula.   "
82019|NCT02212392|"     The use of prophylactic antibiotics is beneficial in reducing the extrapancreatic infections     and shorter hospital stay in patients of acute pancreatitis as compared to controls.   "
90544|NCT02100930|"     The purpose of this study is to be able to supply an experimental combination of drugs called     3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may     benefit from treatment.   "
82020|NCT02212379|"     This multicenter, international, non randomized (single arm), open, phase II trial aims to     evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological     success in virologically suppressed HIV-1 infected patients, of at least 45 years of age,     switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks.     Measurement of primary endpoint will be at 48 weeks. Virological success is defined as the     absence of 2 consecutive plasma viral load >50 copies/mL within 2 to 4 weeks of a dual     raltegravir/etravirin regimen. Raltegravir/etravirine will be considered acceptable if the     percentage of patients in virological success at week 48 is significantly above 90 %.     Assuming a 95 % virological success rate, by including 160 individuals and considering the     strategy to be acceptable if no more than 8 individuals have virological failure;     investigators will have a 95 % probability to discard a combination for which efficacy is     smaller than 90 % and investigators will select with a power of 80 % the strategy for which     the efficacy is above or equal to 95 %. The principal secondary endpoint is the proportion of     patients in therapeutic success up to week 48 and 96.   "
82021|NCT02212366|"     Late Life Depression (LLD) is a serious health problem which not only causes depressed mood     but also results in impairments in memory and attention. These impairments are likely to be     resistant to treatment, which increases the chances of developing dementia even after     successful treatment of mood.This study is a randomized controlled trial of transcranial     Direct Current Stimulation (tDCS) in people with LLD to enhance their cognition after     successful treatment of mood with established medications. tDCS is non invasive, relatively     inexpensive and portable, and has been found to be safe.This study also serves as a pilot     study to assess the effects of tDCS on cognition and neurophysiologic markers of cognition     among patients with LLD. Primary study hypothesis is that participants Participants     randomized to tDCS will perform better on a working memory task 2 weeks and 3 months     following the tDCS course.   "
82022|NCT02212353|"     This small observational study is a contractual component of a 5-year (2013-18) NIHR funded     programme called PERFECTED (Peri-operative Enhanced Recovery hip FracturE Care of paTiEnts     with Dementia) whose overall aim is to develop and pilot an evidence-based intervention to     improve the hospital care of patients with dementia suffering a fractured hip. The findings     from this particular observational study will support other PERFECTED work-packages in     establishing current care practices in acute hospital settings for older people in general     with hip fractures.      Observation is a well-established qualitative technique widely used to understand cultures,     processes and interactions in defined locations including hospitals. In this study,     researchers will observe day-to-day practices on specific ortho-geriatric wards and Emergency     Departments in three English hospitals (Norfolk and Norwich University Hospital, Bradford     Royal Infirmary and Queen's Medical Centre in Nottingham). Observations will occur     intermittently over a 4-week period, covering the full 24h cycle. The prime objective of the     study is to describe delivery of care to older patients with a hip fracture including an     assessment of cost consequences. Crucially, the observations will focus exclusively upon the     hospital personnel that routinely provide care in the designated locations being observed.     Other individuals who frequent the locations (patients, visitors and other more peripheral     health care professionals) are NOT the focus of the research and will be regarded as     incidental others rather than participants. This approach is common in observational     research.      Observations will be conducted by experienced qualitative researchers and assisted by     specifically trained lay researchers to provide a valuable service-user dimension to the     study. Field-notes and contextual information will be collected and thematically analysed,     again in partnership with trained 'lay' researchers. Resulting data will address the     pre-defined aims of the observational study and feed into the findings reported across the     whole of work package 1 of PERFECTED.   "
82023|NCT02212340|"     Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely     used, and there are many clinical trials comparing these on various aspects of anesthesia.     However, there have not been studies comparing the quality of recovery from the different     methods of general anesthesia in vitrectomy. In this study, the investigators compare the     functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40     questionnaire in vitrectomy.   "
82024|NCT02212327|"     The investigators' overarching goal is to improve long-term outcomes for end stage renal     disease (ESRD) patients. In this study we focus specifically on patients receiving peritoneal     dialysis (PD). Volume regulation in PD patients is related to hypertension, heart failure,     nutritional status, and survival. Salt (NaCl) is the body's ion transport target to normally     regulate volume via the kidneys; however, in hemodialysis (HD) patients the dialyser or in PD     patients the peritoneal membrane, must serve that purpose. Determining volume status in PD     patients is not easy and monitoring sodium (Na+) is more difficult still. The investigators     have developed a novel, noninvasive approach to this problem involving 23Na+ magnetic     resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in mostly the skin. Our     technique measures Na+ in skin and skeletal muscle. In this study, we propose to apply this     novel technique to PD patients.      Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls using     Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency bioimpedance     measurements and cross-sectional clinical data.      Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are     increased in PD patients with volume expansion and in those patients with high soluble     vascular endothelial growth factor receptor-3 (sFlt-4) levels.      Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal     function in PD patients.      Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was     found to have no utility in predicting preservation of residual renal function in PD     patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will     fulfill that function and will be inversely, rather than directly, related.   "
82028|NCT02212275|"     The investigators overarching aim is to obtain preliminary data to support a larger grant to     validate a novel objective, physiologically-based outcome measure for clinical trials in     autism spectrum disorders (ASDs) called the cortical metric. Absence of such an outcome     measure has greatly hindered the development of treatments for core symptoms of ASD.   "
82029|NCT02212262|"     Progress in the treatment of myeloma and myeloma bone disease has substantially increased     overall survival, but relapse is inevitable and better treatment is needed. The bone     microenvironment is tremendously complex, so that targeting single interactions between tumor     and bone is unlikely to be effective. Treatments need to block centrally important,     multifunctional pathways. The investigators data point to a central role of the osteocyte to     induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase     due to FGF23 may make systemic inhibitors of heparanase less effective in bone than     elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of     FGF23 excess, such as chronic kidney disease (Shimada & Fukamoto, 2012), and could be used in     MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23 has     adverse effects, but neutralization of FGF23 excess may be practical, or in the future,     suppression of excess FGF23 biosynthesis by osteocytes.      The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho levels     in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this     exploratory study.   "
82030|NCT02212249|"     Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune     disease with a endothelial dysfunction. This study is to evaluated the level of soluble     VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.   "
82031|NCT02212236|"     This Phase II trial aims to evaluate a new psychological intervention to alleviate distress     during haematopoietic stem cell transplantation (HSCT) together with examining feasibility.      HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses. Over     3,000 individuals undergo the procedure every year in the UK with substantial benefits.     However, it is very costly, intensive, and has a range of debilitating side effects.     Consequently, patients often experience considerable distress, which can impede recovery.      A 90-minute, group-based intervention has been developed to address this need based on     psychological theory of adjustment to illness-related difficulties. It is delivered by the     transplant team and involves provision of information to foster more helpful perceptions     about HSCT and facilitating more helpful coping with its difficulties. To evaluate the     effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT     at two sites (Sheffield & Nottingham) will be randomly allocated into two groups. Patients in     the intervention group will receive the new intervention prior to transplantation together     with treatment as usual (TAU) while patients in the control group will receive TAU alone.     Participants and the researcher collecting the data will be blind to the allocation.      Demographic and relevant clinical information will be recorded at the end of participation to     ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and     procedure-related perceptions will be measured at four time points: (i) prior to the     intervention/transplantation, (ii) day of transplant, (iii) two weeks following the     transplant, and (iv) four weeks following the transplant. It is hypothesised that patients in     the intervention group will experience higher resilience and lower distress compared to     controls and that this difference will be mediated by procedure-related perceptions and     coping. A subgroup of participants of those randomised to the group intervention will be     invited to participate in a feedback interview at the end.   "
82032|NCT02212223|"     Insufficient intake of vitamin D is a public health problem, affecting about 40% of the     Finnish population in the winter. Vitamin D has a wide range of health effects: in addition     to its effect on bone, it is known to affect inflammatory response among other things. The     sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements.     In Finland and in Northern Europe vitamin D is formed in the skin only from March to October.     This alone is not sufficient to cover the need for year-round, because vitamin D storage is     used in a few months. During the winter months the only sources of vitamin D are diet and     vitamin preparations. Current vitamin D recommendations are usually based on studies in white     population. However, there can be a difference in the need of vitamin D and in vitamin D     metabolism between different population groups. More research evidence is needed from the     northern countries. The aim of this study is to evaluate the vitamin D need in Somali     immigrant population and in original Finnish population. The hypothesis is that the Somalis     need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original     Finnish population.   "
82033|NCT02212210|"     The purpose of this study is to look to see if adding steroids to an epidural reduces the     chances of having a fever in labor, and protects the baby from exposure to inflammation.   "
82034|NCT02212197|"     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and     safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive     leuprolide acetate administered subcutaneously once monthly during 3 months.   "
82035|NCT02212184|"     The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on     diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods:     Randomized controlled trial (double blinded) with COPD patients, allocated in two group:     intervention (IG) who will receive the Diaphragm Release manual technique on 6     non-consecutive sessions and control group (CG), who will receive a sham protocol (light     touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post     treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be     the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise     abdominal and chest wall kinematics.   "
82036|NCT02212171|"     Background: With new challenges for healthcare, there is a clear consensus among experts on     the need to introduce changes in the organization of care in health centres to address the     problems of over-attendance, bureaucratization and other emerging issues that require growing     amounts of attention. However, there has been insufficient research into possible models and     the impact of their adoption.      The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new     organizational model based on triage and healthcare mini-teams (two general     practitioners/pediatricians, two nurses and one member of the administrative staff) compared     to the current model, aiming to achieve a correct classification of the healthcare needs of     the primary care population and direct them to the most suitable professional.      In addition, the implementation research objective is to identify the facilitators for and     barriers to the implementation of the intervention in the context of primary care.      Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14     healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the     Basque Healthcare Service (Osakidetza) Interior Health Region.      The results will be assessed using the data on morbidity-adjusted attendance of users to     their family doctor, number of referral, addition of new activities to the portfolio of     services, and patient perception and professional satisfaction. All the variables will be     measured at baseline and at the end of the intervention, 24 months later.      Using covariance analysis models, the investigators will estimate the effect attributable to     the intervention by analyzing differences in changes between the two groups, and calculating     the 95% confidence interval, adjusting the comparisons for baseline values. The investigators     will also adjust for potential confounding and effect-modifying variables.      Nominal groups will be held at the end of the intervention with the participation of all the     agents involved in intervention centres to identify the facilitators for and barriers to the     implementation of the intervention.      Discussion: There is a need to develop new forms of organization in primary care services to     respond to new healthcare demands. To pursue this aim, changes have to be introduced in the     organization of healthcare within health centres, redefining the roles of primary care     professionals and refocusing their activity towards population health needs, seeking greater     efficiency in health services.   "
82037|NCT02212158|"     The purpose of this project is to assess the feasibility and efficacy of a new group therapy     program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c).     This intervention is aimed at addressing issues frequently found to be associated with poor     control: knowledge deficits, parental supervision, parent-teen communication and psychosocial     barriers. In order to test this new group therapy program, adolescents' HA1c and psychosocial     functioning will be monitored pre- and post-intervention. It is hypothesized that individuals     who participate in the group therapy program will show an improvement in their HA1c levels     and quality of life, self-efficacy, supportive behaviors from family members, readiness to     make improvements in their diabetes care and decrease symptoms of depression.   "
82038|NCT02212145|"     To evaluate long-term effects of one individual- and population-oriented cardiovascular     prevention programs in primary care.   "
82039|NCT02212132|"     This pilot study is, in this new and original approach in cancer pathology, measure and     explain the correspondence between perceived cognitive impairment (cognitive complaint) by     cancer patients and their cognitive scores goals with tasks metamemory while controlling the     anxiety and depression and fatigue factors of patients.   "
82057|NCT02211898|"     To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of     heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with     swelling of calf and ankle due to disorder of leg venous reflux.   "
82058|NCT02211885|"     Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its     metabolites including excretion and mass balance of parent compound and radioactivity; to     isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine     and feces   "
82040|NCT02212119|"     Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on     muscle tone, and caregiver burden in individuals who are cognitively impaired and who are     fully dependent.      The primary objective is to confirm proof of principle that paratonic rigidity and the     consequences associated with it can be reduced with injection of Botulinum toxin injections     resulting in reduced care-giver burden.      The secondary objectives are to determine optimal time points for evaluation of efficacy in     this patient population and whether the time period is sufficient for washout of Botulinum     toxin effect; determine most salient and sensitive outcome measures; identify obstacles in     data gathering; and lastly, to determine feasibility of battery of assessments in this pilot     study.   "
82041|NCT02212106|"     This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent     Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in     children aged 5 years to less than 9 years. Comparison will be made to a licensed     Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the     2014/2015 influenza season in the US.   "
82042|NCT02212093|"     Severe pneumonia has a high in-hospital mortality. There are few studies which investigate     the long-term mortality in patients that are discharged alive from the hospital. In this     study we want to investigate the 5 years mortality after treatment of severe pneumonia in an     ICU. We will also investigate the cause of death after discharge from the hospital.   "
82043|NCT02212080|"     This study is a first in human study that will investigate the safety, tolerability and     pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled,     randomized, single center design. In addition the bioavailability of two different liquid     formulations will be compared.   "
82044|NCT02212067|"     This trial is conducted in Europe. The aim of the trial is to investigate the effects of     semaglutide on ß-cell function in subjects with type 2 diabetes.   "
82045|NCT02212054|"     The present study was designed to compare the efficacy of conservative treatment to operative     treatment for improvement of constipation symptoms in children with Hirschsprung allied     disease   "
82046|NCT02212041|"     People with mental illness are more likely to smoke and are more severely addicted to     nicotine than the general population. As a result, the number of deaths related to tobacco is     higher.      Smoking is highly addictive because it delivers nicotine very quickly. Research studies show     that people who use nicotine replacement therapies (such us patches, gums, etc) are more     likely to quit smoking than those who try to quit without using these nicotine products.     Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette     (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic     traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals     contained in tobacco cigarettes.      Given the increasing popularity of e-cigs, there is an urgent need to improve our     understanding of both the potential benefits and risks of e-cigs use in people with serious     mental illness. In this pilot we propose inviting 50 people with schizophrenia (or     schizophrenia-related disorder) who are not intending to quit smoking in the near future to     take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week     period in which they will not receive free e-cigs and we monitor which products participants     choose, and a final 24-week follow-up visit. During the 24-week study period we will assess     the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants,     nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as     well as the e-cigs perceived benefits and risks.   "
82047|NCT02212028|"     Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing     recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial     infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage of     60 mg loading dose (LD) followed by 10 mg/day. However, a delay in the onset of its     antiplatelet effects in this particular setting has been consistently shown. administration     of clopidogrel and ticagrelor crushed tablets has been tested and a faster and greater     bioavailability compared to the whole tablets has been observed. However, if the     administration of a crushed prasugrel LD may overcome the above limitation is still unknown     and represents the aim of our study. The proposed investigation will have a prospective,     randomized, design in which STEMI patients undergoing primary PCI will be randomized to     receive two different formulation of prasugrel LD (60 mg whole tablets and 60 mg crushed     tablets). Pharmacodynamic testing will be performed at several time points to test our study     hypothesis that crushed LD regiment will achieve more prompt and enhanced platelet inhibitory     effects.   "
82048|NCT02212015|"     Open-label phase II trial investigating the efficacy and safety of the investigational     combination of pazopanib and paclitaxel.   "
82072|NCT02211703|"     Study Objective:        -  to project the incidence of perioperative hypothermia in patients with elective surgery          under general anesthesia in China        -  to determine the risk factors associated with perioperative hypothermia.        -  to explore the patient outcome of hypothermia such as cardiovascular events, wound          infection,hospital stay and so on.      Study Design: The present study is a cross-sectional study with 30-day follow-up period.   "
82049|NCT02212002|"     The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is     influenced by several factors, such as mode of delivery, gestational age, maternal intestinal     and vaginal microbiota, type of feeding, hospitalization after birth and use of antibiotics     and probiotics.      Gut microbiota of term infants, vaginally delivered and exclusively breastfed, shows a low     count of C. difficile and E. coli and a high number of Bifidobacteria and Lactobacilli, which     positively influence the host's immunity processes; hence, is considered to be ideally     healthy.      Group B Streptococcus (GBS) represents one of the most important causes of neonatal     infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process     from maternal vagina, cervix or rectum, where it resides in 10-20% of pregnant women. In the     last decade, the incidence of early-onset GBS sepsis is significantly reduced, due to the     introduction of GBS universal screening during late pregnancy and consequent intrapartum     antibiotic prophylaxis (IAP) in GBS-positive women.      The use of antibiotics in early life is shown to alter the commensal gut microbiota, thereby     impairing the balance between health and disease later in life. The effect of IAP on     bacterial colonization of the infant's gut, however, has not been largely investigated. The     investigators have previously evaluated the effect of IAP in a relatively small sample of     exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at     7 days of life there were several differences in microbiota composition between infants     IAP-exposed and not exposed.      This observational prospective study thus aims to evaluate these differences in further     detail, expanding the initial sample to formula-fed term infants and following up infants     until one month of age. By including formula-fed infants, the investigators additionally aim     to evaluate the influence of feeding type on the neonatal microbiota composition.   "
82050|NCT02211989|"     To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL   "
82063|NCT02211820|"     Background:      - Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury.     The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain     scan to help diagnose CTE in living patients.      Objective:      - To determine if a new type of brain scan can detect changes that occur in chronic traumatic     encephalopathy.      Eligibility:      - Adults age 18 60 with previous head injury or participation in certain sports.      Design:        -  Participants will be screened with:        -  Physical exam        -  Blood and urine tests        -  Tests of thinking, mood, and memory        -  30-minute magnetic resonance imaging (MRI) brain scan. A magnetic field and radio waves          take pictures of the brain. Participants will lie on a table that slides into a metal          cylinder. They will get earplugs for the loud knocking sounds.        -  Visit 1: Participants will have a 70-minute PET scan of the brain with a small amount of          a radioactive chemical. That will be injected through an intravenous tube (catheter) in          each arm. A catheter will also be put into an artery at the wrist or elbow.        -  Participants will lie on a bed that slides in and out of a donut-shaped scanner. A          plastic mask may be molded to their face and head. Vital signs and heart activity will          be checked before and during the scan.        -  Blood and urine will be taken before and after the scan.        -  Participants will be checked on by phone the next day.        -  Visit 2: Participants will repeat Visit 1 with a different chemical and no artery          catheter.        -  Visit 3: Participants may have a spinal tap. Some fluid will be removed by needle          between the bones in the back.   "
82064|NCT02211807|"     The purpose of this study was to compare the frequency of suicidality and suicide attempt     among HIV patients starting treatment with Efavirenz and with patients starting treatment     with other HIV medications.   "
82065|NCT02211794|"     Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.   "
82100|NCT02211339|"     The purpose of this study is to investigate whether a peer led social skills training     intervention is more effective than a social activity group (i.e. usual care) in improving     social skills following brain injury.   "
82101|NCT02211326|"     The purpose of this study is to determine whether the international pharmacogenetic algorithm     is better than the standard initiation dosing and whether the two algorithms are suitable for     Chinese elderly patients.   "
82066|NCT02211781|"     Background:      - The National Cancer Institute has been studying health risks to people in New Mexico at the     time of the first nuclear bomb test. This was called the Trinity nuclear test. It took place     in 1945. Researchers want to also learn about Native Americans and Hispanics at that time.     They want to learn about their way of life and their diets. This will give a more complete     picture of the health risks to people in New Mexico in 1945.      Objectives:        -  To learn about the activities and eating habits of Hispanic and tribal communities          during the 1940s.        -  To see if a group of Hispanic and Native Americans who were living in New Mexico in 1945          can be gathered.      Eligibility:      - Native American or Hispanic adults who were alive in 1945. They must know firsthand about     the lifestyle and diet in New Mexico at that time.      Design:        -  Participants will have 1 visit. They will be interviewed at a place like a library or          office. They will answer questions about their lifestyle and diet around 1945. This will          take up 60 90 minutes.        -  Participants may agree to have their interviews taped. Their names will not be kept with          their answers from the interviews.   "
82067|NCT02211768|"     Background:<TAB>      - Many people with neurofibromatosis type 1 (NF1) get tumors of the nervous system. Finding     malignant tumors early is important for removing them. Researchers want to find ways of doing     this with scans and genetic testing.      Objectives:      - To learn more about neurofibromatosis type 1.      Eligibility:      - People age 10 and older with NF1 who have a benign tumor or have had a malignant one.      Design:        -  Participants will be screened in another study with medical history, physical exam, and          urine and blood tests. They will have a magnetic resonance imaging (MRI) scan.        -  MRI: Participants will lie on a table that slides into a metal cylinder. They will be in          the scanner for 60 90 minutes, lying still for 15 minutes at a time. Participants will          get earplugs for the loud sounds. They will get a contrast agent (dye) through a thin          plastic tube (catheter) inserted in an arm vein.        -  As part of their regular care, participants will have:        -  FDG-PET/CT scan. They will get radioactive glucose (sugar) through a catheter in an arm          vein.        -  [18F]-FLT-PET/CT scan. This is like the FDG scan but with a different radioactive          chemical.        -  Biopsy. A piece of tumor tissue is removed with a needle. A piece of tissue from a          previous biopsy may also be studied.        -  Participants may have genetic testing. Blood will be taken. It will be tested along with          biopsy samples. Researchers will explain the risks and procedures. They may notify          participants if testing shows health problems.        -  After this study, participants will continue their regular cancer care.   "
82068|NCT02211755|"     Background:      - Researchers want to develop better ways to treat cancer. In this study, they will give     people with cancer two drugs. These drugs have been used on their own to treat some blood     cell cancers.      Objectives:      - To test the safety and efficacy of the drug combination of bortezomib and clofarabine.      Eligibility:      - Adults age 18 and over with advanced cancer that has progressed after receiving standard     treatment or that has no effective therapy.      Design:        -  Participants will be screened with medical history, physical exam, and scans to measure          their tumors. They will also have heart, blood, and urine tests. All of these may be          done by their regular doctors.        -  Participants will get the study drugs in 21-day cyles. They will stay at the clinic for          week 1 of every cycle, then have 2 weeks off.      <TAB>- Bortezomib will be injected under the skin on days 1 and 4.      <TAB>- Clofarabine will be injected in a vein for days 1 5.        -  During cycle 1 only, participants will go to the clinic or their doctor to have a          physical exam and blood tests at the start of the second and third week.        -  Participants will have a clinical evaluation throughout the study, before the start of          each cycle, before receiving treatment.        -  Participants may stay in the study as long as they are tolerating the drugs and their          tumor is not getting worse.        -  Participants will have follow-up for 30 days after the last dose of study drugs.   "
90545|NCT02100917|"     This study is a randomized Trastuzumab-controlled double-blind parallel-group study.   "
82069|NCT02211742|"     Dapagliflozin is a highly selective, reversible and potent inhibitor of the     sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use     as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an     increased glucosuria, and it was shown that mean blood glucose concentrations and     postprandial glucose excursion in special were significantly reduced in type 2 diabetic     patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients     will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin     on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic     patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo     for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over     design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting     glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose     excursions).   "
82070|NCT02211729|"     The primary objective of this study is to determine whether addition of azithromycin (AZ) to     Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine     (AQ) will provide an additional reduction in deaths and severe illness in young African     children. The secondary objectives include an assessment of the safety and cost-effectiveness     of the addition of AZ to SMC with SP+AQ.      This a double blind, randomised, placebo controlled trial. The unit of randomisation will be     the household. Children aged 3 - 59 months will be randomised to receive four cycles of     either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission     season.      Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59     months of age at the start of each period of drug administration will be eligible for     inclusion in the trial provided that parental consent is obtained. Children with a severe,     chronic illness or known allergy to one of the study drugs will be excluded.      Primary endpoint: Incidence of the combination of death or hospital admission for at least 24     hours, not due to trauma or elective surgery during the intervention period      Secondary endpoints:        1. incidence of the primary endpoint during the whole study period        2. attendance at a study health centre with a nonmalaria febrile illness        3. attendance at a study health centre with malaria,        4. the prevalence of moderate anaemia at the end of each malaria transmission season,        5. nutritional status at the end of each malaria transmission season,        6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant          pneumococci before and at the end of each malaria transmissions season,        7. prevalence of resistance markers to SP at the end of the study,      Sample size: 19,200 children (9600 in each country) will be enrolled.   "
82071|NCT02211716|"     The objective of this clinical investigation is to evaluate, in a controlled setting, the     long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System     (Bentley InnoMed) in clincial settings post CE-certification when used according to the     indications of the IFU.   "
84855|NCT02175316|"     This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset     muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC     count, CRP count, CPK count, and pain tolerance.   "
82073|NCT02211690|"     This study aims to describe the proportion of participants with non-occupational     post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to     follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants     who should and do cease study drug because:        1. The participant is found to be HIV-infected (study drugs will be ceased until the          genotype of the infecting strain is determined)        2. The source is found to be HIV-uninfected      The primary study objectives are:        1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using          dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)        2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP)          using dolutegravir with co-formulated emtricitabine-tenofovir      The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100)     eligible participants will receive dolutegravir (one tablet) with co-formulated     emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following     exposures:        1. receptive anal intercourse with a source known to be HIV-infected; or        2. receptive anal intercourse with a source of unknown HIV status; or        3. insertive anal intercourse with a source known to be HIV-infected      There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e.     to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed     at the investigator's discretion.   "
82074|NCT02211677|"     RATIONALE        1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between          actual clinical outcome and TNM stages because it is an anatomy-based system in which          functional factors are not concerned.        2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve          prognosis prediction of TNM staging system in our previous retrospective study.      PURPOSE To validate that the prognostic index based on complete blood count and TNM system     had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system     alone.   "
82075|NCT02211664|"     The objective of this clinical investigation is to evaluate the short- and long-term (up to     24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing     balloon and by Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal     arterial stenotic or occlusive lesions.   "
82076|NCT02211651|"     The purpose of this study is to discover the characteristics of pregnant women which     increases risk for their babies to develop diabetes, later on in life.   "
82077|NCT02211638|"     The puropose of this study is to gain an understanding of the actual use of candesartan     cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters     such as blood pressure.   "
82078|NCT02211625|"     The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics     (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple     ascending doses (Part B) in healthy subjects.   "
82079|NCT02211612|"     To investigate metabolic and molecular response to fatty acid-specific overfeeding in     overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin     sensitivity   "
82080|NCT02211599|"     The purpose of the study is to determine how adding a carbohydrate beverage to a meal with     different protein levels affects the rate at which one's body burns fats, sugars, and     proteins.   "
82081|NCT02211586|"     The purpose of this study is to see what effect this investigational drug has on the body,     and whether it causes a change to how your body uses fats and sugars as fuel sources.   "
82123|NCT02211040|"     The investigators have developed an eHealth intervention based on self-regulation for the     promotion of self-regulation of physical activity and fruit and vegetable intake among adults     who visit general practice. Effectiveness of the intervention will be evaluated in a     three-arm clustered quasi-experimental design in general practice.   "
82082|NCT02211573|"     Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains     the leading cause of mortality in the industrialized world. In order to reduce the     deleterious effects of the atherosclerotic process, proposals for non-pharmacological     treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise     -based therapy. Traditionally aerobic exercises like biking, walking and jogging are     conducted, however, alternative ways such as aquatic exercise training have been proposed,     however, the cardiorespiratory adaptations in this population are not well documented in the     literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic     training (AAT) on body composition, autonomic modulation of heart rate (HR) and     cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal     clinical trial with a sample allocated for convenience, in which twenty-one patients were     male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8),     who was only assessed, and training group (TG, n=13). All patients underwent assessment of     body composition, heart rate variability (HRV) at rest in the supine posture, and     cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The     training protocol consisted of three sessions per week on alternate days for 16 weeks,     totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was     prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET.     Given that these parameters represent risk markers for cardiovascular events in the     population studied, the results suggest that the AAT proposed in this study may be an     important therapeutic strategy to be incorporated into cardiac rehabilitation programs.   "
82083|NCT02211560|"     The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on     cognitive abilities in MCI   "
82084|NCT02211547|"     The primary goal of the study is to determine if there is a difference in pain levels     following the use of low level laser therapy versus placebo and control after placement of     elastomeric orthodontic separators in pediatric patients. To test this, the investigators     will assess the patient's pain levels immediately following separator placement and 24 hours     post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS).     Patients will be randomly assigned to one of three groups: treatment, placebo, and control.     The aim of this study is to establish whether or not low level laser therapy can be used to     reduce pain in pediatric patients following separator placement.   "
82085|NCT02211534|"     The purpose of this study is to investigate whether pulsed electromagnetic energy field     (PEMF) therapy is effective in the treatment of persistent pain following total knee     arthroplasty (TKA)   "
82086|NCT02211521|"     The purpose of this study is to compare the efficacy of platelet-rich plasma versus     hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint.      The hypothesis is that PRP intra-articular injection is comparable or even better than     hyaluronic acid injection.   "
82087|NCT02211508|"     The purpose of this study is to test the safety and efficacy of a noninvasive cortical     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical     Electrostimulation (RINCE) in the treatment of pain associated with fibromyalgia. Patients     who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up     to 24 RINCE treatments delivered by a medical device called NeuroPoint. Approximately 200     fibromyalgia patients will be randomized into one of two study groups. One of these groups     will receive sham treatment, meaning they will receive no treatment at all, while the other     group will receive active RINCE treatment. The study's primary outcome measure will be the     difference between active and sham treatment groups in the mean change from baseline in     patients' weekly worst pain scores. The study's hypothesis is that there will be a difference     between treatment groups in primary outcome measure.   "
82088|NCT02211495|"     The investigators hypothesise that use of a medical device, that increases blood flow to the     foot, will speed up ulcer healing in symptomatic diabetes   "
82089|NCT02211482|"     The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of     dual therapy with 3TC and DTG as initial therapy among naïve HIV patients   "
82090|NCT02211469|"     The primary objective in this study is to assess if single doses of BMS-986104 that are safe,     tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte     count) can be achieved without bradycardia or other adverse events in healthy male subjects.   "
82091|NCT02211456|"     We are investigating ways to help patients with heart failure, which is caused by damaged     hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of     energy and swelling.      Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function     of the main heart chamber in certain suitable people with heart failure. CRT requires a     pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on     the outside of the left heart chamber. These two wires act together to re-time the     coordination of the heartbeat, which is known to improve heart function.      The investigators are assessing whether they might be able to improve heart function even     more by placing two wires on the inside of the left heart chamber, rather than one around the     outside.      The investigators wish to assess whether:        1. Using two wires within the left side of the heart gives a greater increase in heart          function than one.        2. It is possible to choose the best spot inside of the heart by measuring the pattern of          the heart beat.        3. Is it possible to use a different type of heart monitor placed outside the body instead          of a monitor wire inside the heart to assess improvement in heart function? They are          investigating this in people with hearts that beat less effectively than normal.   "
82092|NCT02211443|"     The purpose of this study is to determine whether SCT200 is safe and tolerant in the     treatment of metastatic colorectal cancer   "
82135|NCT02210884|"     Synthesis of vitamin D in the skin through the action of sunlight is a major source of     vitamin D in parts of the world where foods are not fortified with the vitamin. Skin     pigmentation (color), dress habits and season are some of the factors that limit sun exposure     and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important     to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin     D status of lactating women and infants and breast milk vitamin D concentration have never     been assessed. The purpose of this study is to assess changes in maternal and infant markers     of vitamin D status before and after vitamin D supplementation of the lactating mothers.   "
82093|NCT02211430|"     To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant     women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To     this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation     intervention for low-income, minority women conducted in the prenatal and postpartum phases.     Considering the strong link between tobacco use and cancer risk, the development of effective     smoking cessation treatments has important health implications for cancer prevention and     control initiatives. The aims to be addressed are:      Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation     intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e.,     continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short-     and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show     reduced rates of tobacco use, versus those in the BP, over time.      Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of     behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced     fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is     hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on     change of smoking behaviors.   "
82094|NCT02211417|"     This study will compare the safety and efficacy of DS107G (2 g) to placebo in patients with     moderate to severe atopic dermatitis.      DS107G capsules (2 g) will be orally administered for 8 weeks, and will be compared against     placebo.      This study will enroll approximately 100 adult patients.   "
82095|NCT02211404|"     Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide     Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit   "
82096|NCT02211391|"     Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be     measured with the microdialysis technique by measuring glycerol concentration and blood flow     in abdominal adipose tissue. Morning fat oxidation will be measured with indirect     calorimetry.      The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis     rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize     that casein and placebo will not be significantly different from each other in terms of     overnight lipolysis.   "
82097|NCT02211378|"     This randomized controlled trial aims to determine if the stress response and performance of     trainees who are observers in simulation training is similar to trainees who are actively     participating in simulation training in the 'hotseat' during 3 consecutive simulation     sessions.      We hypothesize that trainees experience less stress when they are observers in the first 2     simulation sessions. However, when they are placed in the 'hotseat' during the third session,     their stress response, as well as their performance, will be similar to trainees who spend     all 3 simulation sessions in the 'hotseat'.   "
82098|NCT02211365|"     The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the     management of essential hypertension by integrating the activity of general practitioners     (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously     allocated in the regional area, and the Hypertension Clinic of the Federico II University in     Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store     clinical data detected at each visit between the peripheral units and the co-ordinating     centre and to support scientific analysis of the dataset.   "
82099|NCT02211352|"     The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease     central blood pressure in subjects with hypertension.   "
82102|NCT02211313|"     A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as     treatment of urinary stone disease. Stents are designed to help provide drainage of the     kidney in the setting of an obstructing stone, or postoperative swelling of the ureter.     Though their presence is only temporary, stents are associated with a significant amount of     patient discomfort and bother, which can negatively impact overall satisfaction. Over the     past decades, there have been refinements in stent technology and usage philosophy. Smaller     and softer stents are now available for use in patients, though studies evaluating the     relative benefits have been conflicting. The investigators aim to evaluate the effect of     stent size and composition upon outcomes after the treatment of stone disease, including     patient comfort and satisfaction.   "
82103|NCT02211300|"     The objective of this study is to demonstrate that the OptiScanner® is safe and can provide     accurate blood glucose levels in critically ill subjects.      Accuracy Hypothesis:      The assessment of blood glucose level that results from the OptiScanner is comparable to the     YSI 2300 STAT Plus™ Glucose and Lactate Analyzer (YSI Analyzer; YSI Life Sciences, Yellow     Springs, OH).      Safety Hypothesis:      The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated     automated blood glucose levels for critically ill subjects.   "
82104|NCT02211287|"     The purpose of this study is to evaluate the application of a best-practice Advance Care     Planning (ACP) model for individuals living with dementia in a sample of nursing homes in     Northern Ireland   "
82105|NCT02211274|"     Older adults prefer to live as in the community as long as possible. Creating a standardized     treatment planning process that includes assessments of everyday competence and goal-setting     techniques to help Veterans move from VA nursing homes back to the community can improve     functional health, well-being, and quality of life for older Veterans. Research has shown     that 29% of nursing home residents might be able to live safely in the community instead.     Currently, VA provides nursing home care to more than 13,000 Veterans across the country,     which costs about $3.3 billion a year. It is expensive for VA to provide nursing home care to     these inappropriate residents and they are using limited resources that could be given to     another Veteran with more urgent needs. The Everyday Competence Assessment and Planning for     Community Transitions (ECAP-CT) toolkit will help these Veterans to move back into the     community with the services and supports they need based on their individual level of     everyday competence.   "
82106|NCT02211261|"     A first in human study to determine the safety, tolerability and pharmacokinetics of single     and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus   "
82107|NCT02211248|"     Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional     treatment of hypertensive patients will provide better parameters for comparing the two     approaches.   "
82108|NCT02211235|"     Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes     recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2     diabetes. Increasing evidence supports treating early glucose abnormalities in cystic     fibrosis patients to target CF specific outcomes, including lung function and nutrition     (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in     the `prediabetic' state are unclear. A more accurate characterization of blood sugar     variability in youth with and without CF will help the investigators better interpret     continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and     more accurately identify those individuals at greatest risk for disease progression.   "
82109|NCT02211222|"     This Expanded Access Program (EAP) consists of a Prerandomization Phase and a Randomization     Phase. Only subjects with radioiodine-refractory DTC who fulfill the eligibility criteria     will be treated. These subjects will be treated until progression of disease or unacceptable     toxicity.   "
82110|NCT02211209|"     The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52     weeks in patients with Familial Chylomicronemia Syndrome   "
82111|NCT02211196|"     This pilot clinical trial studies evidence-based tobacco cessation strategies in patients     with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit     smoking.   "
82112|NCT02211183|"     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™     device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff     Tear .   "
82113|NCT02211170|"     Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses     induced by endotoxin in healthy humans   "
82114|NCT02211157|"     Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating     multiple doses with and without a 64 g fat breakfast at the 50 mg dose level   "
82115|NCT02211144|"     Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as     multiple daily doses at various dose levels   "
82116|NCT02211131|"     This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of     talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery     alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.   "
82129|NCT02210962|"     There is accumulating experimental evidence to suggest the role of essential fatty acids     (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to     be dysfunctional on early stages of schizophrenia, according to neurodevelopmental     hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich     diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular     importance at the beginning of the illness. As a relatively safe option, EFA supplementation     would be a preferable add on therapy in treating individuals with a first episode of     schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up     studies of EFA supplementation in FES patients were carried out. The demonstration of the     efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would     be a strong basis for further studies and prescribing EFAs for a large population of patients     who are in the early stages of that debilitating illness.   "
82130|NCT02210949|"     Pre-treatment of patients with erythropoietin subcutaneously and iron supplement     intravenously, in order to create a clinical pathway to minimize transfusion of red blood     cells in a selected group of cardiac patients with an increased risk for blood transfusions     in our cardiac surgery program.   "
82117|NCT02211118|"     A variety of medications have been used to treat the anxiety, discomfort, and fear associated     with continuous and sudden episodic breathlessness in patients with advanced respiratory     disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed     for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,     especially respiratory depression, so they frequently prescribe benzodiazepines. Recent     studies have shown that benzodiazepine use is associated with increased adverse respiratory     outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).      Dexmedetomidine may be an alternative to current drug therapies for breathlessness.     Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without     respiratory depression or cognitive dysfunction. The drug can be administered intranasally to     induce light to moderate sedation of several hours duration.      The objective of the proposed research, a pilot study, is to assess the dose dependent safety     and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD.     This will be accomplished in a staffed acute care setting with routine vital signs monitoring     and pulse oximetry. Patients will be assessed objectively and subjectively for their level of     sedation by validated sedation scales.      This pilot study is an initial investigation of a drug with favorable pharmacologic     properties in this patient population with distressing and difficult to treat symptoms. The     pilot study may provide evidence that a larger trial is needed to confirm the study results,     or evidence that additional study in symptomatic patients and treatment comparison trials     should be pursued.   "
82118|NCT02211105|"     The purpose of this prospective observational research study registry is to examine whether     two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless     Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side     effects and post-procedure costs associated with episodes of care and any ensuing     complications.   "
82119|NCT02211092|"     The purpose of this study is to develop an individually tailored home-based physical activity     intervention for family caregivers of people with advanced cancer and assess the feasibility     of a future randomized controlled trial (RCT) to test the effects of this intervention.   "
82120|NCT02211079|"     The purpose of this study is to assess the effects of single and multiple once daily doses of     50 milligram (mg) of JNJ-54861911 on pharmacokinetics (PK) (study of the way a drug enters     and leaves the blood and tissues over time) of caffeine, midazolam, and tolbutamide in     healthy male participants.   "
82121|NCT02211066|"     The study is a single-centre, randomized, active controlled, open label clinical trial. The     primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately     after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)   "
82124|NCT02211027|"     Hypothesis The incidence of toxicity in patients receiving the tumor DNA-transfected     fibroblast vaccine will be acceptably low and the immunologic response rate sufficiently high     to warrant further study of this therapy      The study of the vaccine will proceed in two stages after the method of Simon (102). In the     first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic     responses occur, the study will be terminated. If 3 or more responses are observed, the study     will proceed to the second stage, accruing an additional 22 patients. If the second stage is     complete and a total of 9 or more immunologic responses are observed among the 37 patients     treated, the treatment response rate for the vaccine will be considered high enough to     warrant further study. Conversely, if the evaluation of the vaccine concludes at the first     stage, or if 8 or fewer total immunologic responses occur after completing the second stage,     the vaccine will not be considered for further study.   "
82125|NCT02211014|"     To characterize the safety profile of acalabrutinib with and without dexamethasone in     subjects with relapsed or refractory Multiple Myeloma (MM)   "
82126|NCT02211001|"     The purpose of this study is to evaluate and compare the effects of three Exercise Movement     Techniques Global Postural Reeducation(RPG), Pilates method and Segmented Dynamic Exercises     (SDE) regarding muscular strength and endurance of the trunk, spine mobility and flexibility     of the posterior muscle chain.   "
82127|NCT02210988|"     The investigators design a randomized, single blinded, control study to evaluate the     therapeutic effect of acupuncture in acute ischemic stroke patients:   "
82128|NCT02210975|"     Sleeve gastrectomy (SG) has gained popularity as both a staged and a definitive procedure for     morbid obesity due to its technical simplicity, low-morbidity and excellent results both for     weight loss and control of metabolic syndrome. There are however reports of SG worsening     pre-existing GERD or causing new-onset GERD. Because of this, patients with pre-existing GERD     have been denied the benefits of SG. In addition, patients that develop post-op GERD cannot     undergo traditional anti-reflux surgery since the gastric fundus that is required for     fundoplication is removed during the SG. Hence, patients with post-SG GERD not adequately     controlled with medication can only opt for the more invasive gastric bypass procedure as     their only surgical treatment option.      In a recently reported case study, an obese patient with severe GERD successfully treated     with EndoStim underwent SG and maintained adequate GERD control with continued use of LES     stimulation therapy. However electrical stimulation was not yet tested systematically in     patients with prior gastric operation such as sleeve gastrectomy.      This study will test the hypothesis that electrical stimulation is effective in control of     GERD associated with SG.   "
82144|NCT02210767|"     This study will evaluate the effects of walnut-derived ALA and bioactives on multiple CVD     risk factors, including central blood pressure, arterial stiffness indices, inflammatory     markers, urinary isoprostanes, vascular adhesion markers, and changes in lipids and     lipoproteins. Gut microbiome changes due to walnut consumption will also be assessed using     the 16S rRNA gene.   "
85078|NCT02172417|"     Study to investigate the effect of an inhibition of the renal cationic drug transporter on     single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical     Chronic Obstructive Pulmonary Disease (COPD) population   "
82131|NCT02210936|"     Brandeis University and University of South Carolina (USC) have joined together to develop     the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic     detailing (medical education) intervention for physicians and evaluate its effectiveness in a     pilot study. The goal of the intervention is to increase the use of safe prescribing and     prescription monitoring practices among primary care physicians. The research team will     design and pilot an educational intervention for physicians who treat military personnel,     veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to     prevent the onset or progression of prescription drug problems among Iraq and Afghanistan     veterans, military members, and their families who are at high risk for developing problems     if their treatment involves long-term use of an opioid.   "
82132|NCT02210923|"     Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall in     blood pressure in patients with resistant hypertension. Since the activation electrodes are     implanted at the level of the carotid sinus, it is conceivable that the nearby located     carotid body chemoreceptors are stimulated as well. Physiological stimulation of carotid     chemoreceptors not only raises respiration, but it also increases sympathetic activity which     may in part counteract the effects of BAT. The aim of the present study is to investigate     whether there is evidence for concomitant carotid chemoreflex activation during BAT. We     hypothesized that there is no clinically relevant co-activation of the carotid body     chemoreceptors during BAT in patients with resistant hypertension.   "
82133|NCT02210910|"     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™     in the study population in comparison to surgical RCT repair.   "
82134|NCT02210897|"     Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction.     Whereas the diagnosis is based on an increase and/or decrease in the concentrations of     cardiac troponins with at least one value above the 99th percentile value of the reference     population together with the evidence of ischemia, serial sampling is needed. Knowledge of     the variation in cardiac troponin levels over time in individuals in a normal rest state (not     during an acute myocardial infarction), also called the biological variation, is important     regarding the interpretation of the serial cardiac troponin levels. A recent study by our     group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is     important regarding the interpretation of the serial cardiac troponin levels.      Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The     mechanism of the elevated concentration of cTn in these subjects is still unclear. It is     hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it     is not clear whether renal function affects the biological variation and circadian rhythm of     cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with     impaired renal function creates the opportunity to assess the effect of renal clearance on     the circadian rhythm of cardiac troponins.   "
82165|NCT02210481|"     Comparison between intravitreous glucose rate and macular thinning measured by Ocular     Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular     membrane. Hypothesis : Association between post-operative macular thickness and intravitreous     glucose rate   "
82136|NCT02210871|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after     a single injection of semaglutide in subjects with mild, moderate or severe hepatic     impairment compared to subjects with normal hepatic function.   "
82137|NCT02210858|"     This phase I/II trial studies the side effects and how well tipifarnib works in treating     patients with chronic myeloid leukemia, chronic myelomonocytic leukemia, or undifferentiated     myeloproliferative disorders. Tipifarnib may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth.   "
82138|NCT02210845|"     The objective of this study is to investigate whether a behavioral modification intervention     in the form of either a 6-month supervised training program or a 6-month financial incentive     weight loss program, results in improvement of diabetes outcome such as overall sugar control     and lipid control.   "
82139|NCT02210832|"     Investigators will examine whether adding financial incentives to current best practices for     smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a     telephone quit line) increases cessation rates and improves infant health. While more     expensive upfront compared to best practices alone, the investigators hypothesize that this     treatment approach will be economically justified by the later cost savings associated with     more women quitting, having healthier babies, and needing less healthcare. It should also     help to reduce the greater risk for health problems often seen among those who less well off     economically.   "
82140|NCT02210819|"     Following the findings of the clinical trials in drug development, this global     non-interventional cohort field study will investigate rivaroxaban under clinical practice     conditions in comparison with current standard of care for patients with acute venous     thoromboembolism (VTE).      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of     acute VTE in routine clinical practice.   "
82141|NCT02210806|"     This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry     powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI     Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.   "
82142|NCT02210793|"     The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser     vision correction using no-touch all-laser photorefractive keratectomy in comparison to     conventional lasik   "
82143|NCT02210780|"     This is a 32-week, randomized, double-blind, placebo-controlled, parallel-group study     assessing immunization responses to vaccination in adults with moderate to severe atopic     dermatitis who are treated with subcutaneous dupilumab.   "
82214|NCT02209844|"     To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847   "
82145|NCT02210754|"     This trial was the initial characterization of the blu™ products being studied, with the     purpose of gaining an understanding of the exposure to nicotine and craving reduction     attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were     utilized: a single controlled administration and a short-term ad lib use. As smoking     behaviors vary from smoker to smoker, a controlled administration allows for some     standardization of nicotine dose for each of the study products to better understand their     uptake characteristics as well as urge reduction achieved under controlled conditions.     Further evaluation under ad lib product use conditions provides insight into product     self-administration behaviors that will allow subjects to achieve acceptable levels of urge     reduction. Comparisons were made to evaluate differences between blu™ formulations as well as     to the market-leading conventional cigarette, Marlboro Gold King Size (Marlboro cigarette').   "
82146|NCT02210741|"     Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence     of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic     predisposition. Despite its clinical and scientific significance, Graves' disease is still     mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune     repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a     snapshot and a historical record of a person's immune function. Thanks to the power of     next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell     receptors suddenly becomes plausible, and opens a door for many creative approaches to study     immune related diseases. The ultimate goal of this project is to use both the NGS deep     sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine     mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore,     using the immune repertoire approach, investigators want to study the critical epitopes of     thyroid auto-antigens, and to delineate the pathophysiological steps in various disease     stages and in various sub-groups. Investigators expect to solve the immune repertoire of     Graves' disease of different sub-group presentations and at various disease activity stages.   "
82148|NCT02210715|"     People infected with HIV are living longer thanks to the use of antiretroviral therapy     (cART). In aging HIV persons, other factors are associated with early death. One of the major     factors is liver disease, which can be due to liver infections or reasons such as fatty     liver. Fatty liver in the general population is a serious problem, affecting 30% of Canadian     population. A specific type of fatty liver characterized by much inflammation, named     nonalcoholic steatohepatitis (NASH) can lead to cirrhosis and death. Persons living with HIV     can be at increased risk of NASH because of toxic effect of certain types of cART on the     liver, obesity and other metabolic factors (for example diabetes). Some scientific data     suggest that newer cART are associated with less fatty liver and liver damage. However, NASH     has not been studied in detail in persons living with HIV. One reason for the lack of     research is one of the only ways to detect liver disease is to undergo liver biopsy which can     be painful and has complications. Recently, a new non-invasive technology (Fibroscan) has     been developed which can tell doctors how much a liver is damaged and how much fat it     contains without pain or complications. Moreover, a simple test measuring a specific protein     in the blood, the cytokeratin 18 (CK-18), can help the diagnosis of NASH. We will study the     effect of switching cART to newer types of HIV medication in patients with a non-invasive     diagnosis of NASH done by Fibroscan and cytokeratin 18. We expect that switching older cART     to less hepatotoxic drugs will lead to improvement of liver damage, fatty liver and NASH     diagnosed by Fibroscan and cytokeratin 18. To evaluate this approach we plan to recruit 58     consenting HIV mono infected patients with non-invasive diagnosis of NASH and/or fatty liver     with liver damage. Participants will undergo Fibroscan, a blood test for cytokeratin 18, a     complete physical examination and laboratory tests every 3 months for 12 months, then at 18     and 24 months. The effect of the switching of HIV medications will be recorded. We anticipate     that the current study will provide evidence for reduction of inflammation and liver damage     with newer cART for treatment of HIV infection.   "
82161|NCT02210546|"     A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of     sensitivity, specificity, and predictive value, in the screening of women at intermediate     risk of breast cancer.      Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio     to:        1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or        2. Yearly MRI.   "
82149|NCT02210702|"     This is a prospective, randomized, controlled cohort study. This study will look at the     effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20     mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when     compared to a control group using no hormonal contraception. Depressive symptoms and sexual     function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona     Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W).     Participants will begin taking the medication at Week 3 postpartum, and these outcomes will     be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators     hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and     BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and     increase in sexual function in both of the oral contraceptive groups.   "
82150|NCT02210689|"     A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing     Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™,     Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the     treatment of bacterial vaginosis in non-pregnant women.   "
82151|NCT02210676|"     Aim:      The purpose of the study is to learn more about how a person recovers after treatment for     mallet finger injury. The investigators want to identify the best outcome after mallet finger     injury and how to improve treatment strategies.      Primary null hypothesis:      There are no statistically significant factors associated with extensor lag between 4 weeks     and 4 months after immobilization is discontinued for a mallet finger among demographic,     injury, and treatment factors.      Secondary null hypothesis:      There are no statistically significant factors associated with PROMIS upper extremity     function between 4 weeks and 4 months after completion of immobilization for a mallet finger     among demographic, psychological, injury, and treatment factors.   "
82152|NCT02210663|"     This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and     preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid     tumors.   "
82215|NCT02209831|"     Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.      Safety and tolerability were also assessed.   "
90843|NCT02097043|"     This study is a phase I clinical trial for evaluating the pharmacokinetics and     safety/tolerability of DA-7218 in healthy male volunteers.   "
82153|NCT02210650|"     Patients with a ureteral (the tube that leads from the kidney to the bladder) stone often     also have small stones in the kidney (frequently visible on CT). If these small kidney stones     are determined to be asymptomatic (not causing any problems or pain), then most urologists     will simply remove the symptomatic ureteral stone and leave the additional stones in the     kidney above. However, the investigators know that the ureteral stone started in the kidney.     This means that the small stones remaining in the patient's kidney may cause problems later.     The purpose of our research is to test if removing small stones from the kidney prevents     future stone episodes   "
82154|NCT02210637|"     To evaluate the association of non attendance at scheduled appointments with visits in the     emergency department, hospitalizations and mortality during one year follow up.   "
82155|NCT02210624|"     The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived     stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an     emerging alternative treatment modality in incurable and intractable neurological disorders.     This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain     injury.   "
82156|NCT02210611|"     The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved     with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination     than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH     antagonists.   "
82157|NCT02210598|"     This study represents the first randomized trial comparing traditional inpatient induction     with a transcervical foley catheter versus outpatient induction with immediate removal of a     transcervical foley catheter. The immediate removal technique allows the induction process to     begin in the hospital setting, but allows the patient to go home without a foreign body in     situ. The investigators hypothesize the outpatient group will spend less time hospitalized     prior to discharge. Additionally, the investigators will explore the vaginal delivery rates     and maternal/neonatal safety profiles between groups.   "
82158|NCT02210585|"     The study was designed to test the following hypotheses:      Main Objective:      To compare the level of spontaneous physical activity at 3 months after re-entrainment by     multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to     conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation)     (control arm).      Secondary Objectives:      To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical     activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.      Design:      We will conduct a multicenter controlled study vs. reference care with randomization into two     parallel groups and double-blind (placebo electrostimulation). Patients will have the ES     material available at home and will be supervised by monthly visits over 3 months and by     telephone follow-up for two years. The study size calculation is based on physical activity,     the percentage of lean body mass and arterial stiffness measured in the OBEX study.      This project will determine whether the training strategy is effective for increasing     physical activity and/or in inducing significant metabolic and cardiovascular effects in     these patients after 2 years. In addition, it provides a solid base of investigation for the     study of the interactions between muscle contraction and cardio-metabolic health with greater     precision.   "
82159|NCT02210572|"     It has been shown that patients complaining of gas-related symptoms significantly improve on     a diet low in fermentable residues. However, other studies suggest that some non-absorbable,     fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce     beneficial effects to the host, including improvement of abdominal symptoms. The aim of the     study is to compare the effects of a diet low in fermentable residues versus a diet     suplemented with prebiotics on intestinal microbiota composition, microbiota activity     (intestinal gas production) and digestive symptoms.   "
82160|NCT02210559|"     This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019     administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced,     unresectable pancreatic cancer.   "
82166|NCT02210468|"     The mechanism of Osteoarthritis (OA) is complex, however the investigators know that     cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes,     leading to proteases that break down cartilage. There is a protein in the human blood called     alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage.     Cytonics developed a device that use the patient's own blood to remove all cells and     concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.   "
82167|NCT02210455|"     Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children,     and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum     disorders (FASD) was established to encompass the full spectrum of teratogenic effects     induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in     North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births,     making this a public health problem of epidemic proportion. Even though considerable efforts     have been aimed at identifying children with FASD, the need for access to services and     supports for Canadian families affected by FASD remains unfulfilled. Additionally, there is     little empirical data available to influence policy change in how these services and supports     are delivered.      A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol     Spectrum Disorder (FASD): A Framework for Action document was the need to determine the types     of supports children with FASD and their families require and to develop appropriate     mechanisms to provide these services at the community, provincial/territorial and federal     levels. This identified need forms the basis of the current proposal.      Although a variety of psychosocial interventions have been developed to treat     neurobehavioural disorders, relatively little research has been conducted that is     specifically aimed at improving the behavioral challenges identified in children with FASD.     Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be     developed using input from major stakeholders to meet the current limitations in access for     families seeking services and supports; and (ii) this intervention and its evaluation will     provide evidence for feasibility and efficacy to support changes in policy by key     decision-makers and provide the basis for developing promising practices in the area of     interventions for families affected by FASD. This grant will link academic teams with     parents/guardians and decision makers to develop and evaluate a training program for the     parents/guardians of children with FASD.      Participants will be recruited from across Canada. The specific objectives of the proposed     research program, which will be addressed in three inter-related studies, are to:        1. Develop an Internet-based intervention program for parents/guardians of children with          FASD between the ages of 4-12 years, that is based on information collected from          interviews completed by major stakeholders (e.g., parents/guardians, clinicians,          decision-makers, community-based organizations);        2. Evaluate the feasibility (usability) of the intervention; and        3. Obtain data on outcomes from the randomized controlled trial This research will adopt an          integrated knowledge translation and exchange approach where knowledge production,          dissemination, uptake and usage will occur seamlessly throughout the project and          researchers and knowledge users are engaged in the project right from its inception.      The intervention will be based on the Strongest Families program that is designed to help     families learn to deal with common childhood problems in the comfort and privacy of their     home, and provide treatment and care via telephone contact with trained coaches, written     manuals, videotapes, and audiotapes. This program has been successful in children     neurodevelopmental disorders; and will be adapted for use in the FASD population, as children     with FASD, share many of the same behavioral characteristics.   "
82168|NCT02210442|"     A multicenter study to evaluate the effectiveness of a teaching strategy based on the     incorporation of educational games with simulated settings versus usual practice based on     diffusion for the implementation of clinical practice guidelines in Family Medicine Residency     Program. The impact of the new strategy will be measured in improving knowledge and skill     acquisition in clinical decision making of Family Medicine Residency Program after 6 months.     Effectiveness will also be measured a month and 12 months after intervention.   "
82169|NCT02210429|"     We hypothesize that patients who receive a supraclavicular block via Angiocath, placed     intra-operatively and dosed post-operatively following neurologic examination, will have     lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care     unit, and lower rates of intervention for post-operative nausea and vomiting. We also     hypothesize that patients receiving this nerve block had the same rates of nerve damage as     the patients who did not receive a block and that there will be no demonstrable safety     concerns with this block.   "
82170|NCT02210416|"     Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of     short-term advantages compared to open hernioplasties with mesh. In the prevailing economic     climate, the total costs of treatment is a subject of intense research. This study is     designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a     special emphasis in costs of treatment, complications and convalescence.   "
82171|NCT02210403|"     The purpose of this study is to determine whether tDCS in combination with motor training can     improve hand and arm function in stroke patients.   "
82172|NCT02210390|"     Aim:      To assess the Feasibility RCT of the efficacy of a culturally adapted psychological     intervention for Bipolar disorder in Pakistan      Design:      Randomized Control Trial      Setting:      Psychiatric Departments of different Hospitals in Karachi.      Participants:      A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and     treatment as usual arm.      Intervention:      Culturally Adapted psychological intervention for bipolar disorder      Outcome measure:        -  Acceptance of intervention in terms of attending session and dropouts        -  Knowledge and attitudes towards bipolar disorder   "
82173|NCT02210377|"     Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may     contribute to cardiovascular events and high mortality. The etiology of IDH is     multifactorial; therefore, it remains a challenging problem in the management of HD patients.     Because moxibustion (MO) at specific points can influences hemodynamics, we hypothesize that     Tianjiu (auto-MO) at the traditionally used meridian points will reduce the severity of     hypotension in patients who undergo HD.   "
82174|NCT02210364|"     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin     (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast     Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the     recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety     profile, to explore the feasibility of PM01183 dose optimization, to characterize the     pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity     of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.   "
82175|NCT02210351|"     The asses and evaluate whether trans apical access for TAVR is associated with apical     dysfunction.   "
82176|NCT02210338|"     The study aims to determine the better device to facilitate intubation in patients with a     limited neck movement and small mouth opening. This may help anesthesiology as well as     emergency medicine practitioners and departments to decide when choosing between these two     conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior     when compared to the Bonfils Intubation Fibrescope in success of intubation, time to     intubation and complication rate in patients with a fixed cervical collar.   "
82177|NCT02210325|"     This study will compare a single dose of oral solithromycin to the standard of care     (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with     urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin     resulted in 100% microbiological eradication in male and female patients with uncomplicated     urogenital gonorrhea.   "
82178|NCT02210312|"     Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions     such as attention, perception, concentration, learning, abstract thinking and problem solving     are impaired postoperatively. These changes can be resolved after weeks and months. In some     cases, changes are permanent.   "
82179|NCT02210299|"     People are, especially in industrialized countries, exposed to a growing number of ubiquitous     chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and     dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought     to contribute the most to total exposure for many chemicals, the relative contribution of     each pathway is nevertheless poorly described, and can be different among populations. This     is in particularly the case For young children, who can be more exposed via the environment,     because of frequent contact with object and dust and hand to mouth behaviors. Children are in     addition considered more sensitive to chemical risk due to their maturating systems.      In this context, the objective of this project is to characterize the young children's     exposure to a particular class of semi volatile organic compounds. It will encompass the     relative contribution of different pathways to the external dose, and to try to match the     internal and external doses with a physiologically based pharmacokinetic (PBPK) model for     molecules for which it is possible.      The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated     Substances (PFAS), used in numerous consumer products.   "
82180|NCT02210286|"     The purpose of this study is to examine the effects of supplementing Magnesium L-Threonate in     people with mild to moderate dementia . The investigators goal is to understand whether     Magnesium L-Threonate will be associated with improvement in memory and brain function.   "
82216|NCT02209818|"     The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain     management in people commencing orthodontic treatment. The study design is a randomized     controlled trial.      Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly,     and the other side will be treated by a placebo procedure. Pain assessment will be measured     using Visual Analog Scales (VAS).      The hypothesis of this study is that laser irradiation decreases the amount of pain following     the insertion of orthodontic separators.   "
82217|NCT02209805|"     Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as     multiple daily doses at various dose levels.   "
82182|NCT02210260|"     Limiting surgical stress and managing postoperative pain are well understood to influence     recovery and outcome from major surgery for colorectal cancer and both are fundamental     aspects of enhanced recovery protocols.      Traditional approaches for dealing with these problems such as epidural or patient controlled     intravenous opioid analgesia are associated with problems that may be detrimental to     postoperative recovery and surgical outcome. As a result there is evidence in the literature     of increasing interest in alternative techniques such as intrathecal anaesthesia or     continuous wound infusion of local anaesthetic, however nobody has examined the effect of     combining the techniques or their impact on the surgical stress response.      We intend to compare patients undergoing major resections for colorectal cancer receiving     intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those     receiving a continuous wound infusion alone. We will examine the surgical stress response and     postoperative pain control in addition to objective measures of postoperative recovery.      We suggest that our approach will attenuate the surgical stress response and provide optimal     pain control that will ultimately translate in improved recovery and outcome following     surgery for colorectal cancer.   "
82183|NCT02210247|"     The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL     via local subcutaneous infiltration in healthy volunteers.   "
82184|NCT02210234|"     The purpose of this research was to understand the effects of bioactive compounds found in     wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole     wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function     assays were performed at both sampling times. It was predicted that eating wheat bran would     benefit immune function.   "
82185|NCT02210221|"     The research aims of the CENTER-TBI study are to:        1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a          European context, and        2. identify the most effective clinical interventions for managing TBI.      Specific aims        1. To collect high quality clinical and epidemiological data with repositories for          neuro-imaging, DNA, and serum from patients with TBI.        2. To refine and improve outcome assessment and develop health utility indices for TBI.        3. To develop multidimensional approaches to characterisation and prediction of TBI.        4. To define patient profiles which predict efficacy of specific interventions (Precision          Medicine).        5. To develop performance indicators for quality assurance and quality improvement in TBI          care.        6. To validate the common data elements (CDEs) for broader use in international settings,          and to develop a user-friendly web based data entry instrument and case report form          builder.        7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury          Research (FITBIR).        8. To intensify networking activities and international collaborations in TBI.        9. To disseminate study results and management recommendations for TBI to health care          professionals, policy makers and consumers, aiming to improve health care for TBI at          individual and population levels.       10. To develop a knowledge commons for TBI, integrating CENTER-TBI outputs into systematic          reviews.   "
82186|NCT02210208|"     An open, non controlled, multi-centre, clinical investigation to verify performance and     safety of a soft silicone wound contact layer containing silver in the treatment of skin     grafts in surgical burn patients and the usefulness of a marketed donor site dressing.   "
82187|NCT02210195|"     The primary aim of the supplemental study is to provide POC testing of aprepitant as a     treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in     the parent grant will likewise be applied to the supplemental project to test for effects of     aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The     primary hypothesis is that subjects treated with aprepitant will have significantly less     alcohol and marijuana use than subjects treated with placebo.   "
82188|NCT02210182|"     The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety     and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects     Undergoing Thermal Ablation   "
82189|NCT02210169|"     Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will     be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over     1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering     vancomycin as a continuous infusion will result in improved attainment of target     concentrations in blood at steady state (when the drug is in equilibrium) compared to     intermittent infusion.   "
82190|NCT02210156|"     The purpose of this study is to determine whether the consumption of a nutritional supplement     with micronutrients and herbal extracts has an effect on the incidence of acute respiratory     infections in susceptible adults.      Our hypothesis is that subjects who consume the nutritional supplement will have a lower     incidence and duration of acute respiratory infections in comparison with the placebo group.   "
82191|NCT02210143|"     The aim of this study was to evaluate the reliability of the avascular root surface area as a     prognostic identification criterion for gingival recessions and to compare the predictive     value of the Miller classification and avascular root surface area (AERSA) calculation on the     final root coverage outcomes.   "
82218|NCT02209792|"     The primary objective of this extension study was to obtain long-term safety data for BIRB     796 BS in patients with moderate to severe Crohn's disease after 26 weeks of treatment.     Secondary objectives were the evaluation of efficacy of BIRB 796 BS to induce clinical     remission and response over 26 weeks of treatment.   "
82219|NCT02209779|"     The objective was to determine the effects of BIRB 796 BS on CRP and clinical parameters in     Rheumatoid Arthritis as measures of efficacy, and on population pharmacokinetics and safety     parameters   "
82221|NCT02209753|"     The clinical objective of this study was to determine the effect of BIRB 796 BS on     pharmacodynamic markers of psoriasis as a measure of efficacy, to determine the population     pharmacokinetics of BIRB 796 BS and to determine the safety of BIRB 796 BS over 4 weeks of     treatment in patients with moderate to severe plaque-type psoriasis.   "
91100|NCT02093663|"     To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in     children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who     are in remission.   "
82192|NCT02210130|"     Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability     in the general population, secondary to the accumulation of asymptomatic elementary lesions.     CSVD is directly correlated with age and cardiovascular risk factors and therefore would be     challenging in term of public health care in the future. While HIV patients share the same     cardiovascular risk factors and they are often diagnosed with cognitive impairment and     frailty, CSVD has not been yet described in this population.      The global aim is to study and describe the CSVD in the HIV+ population by: (1) correlating     the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with     the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular     disease.      HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough     vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the     macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination     and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel     organs. The same number of HIV+/CSVD- matched patients will have the same work-up.      We are expecting to show the relationship between CSVD and cardiovascular risk factors in     order to propose specific prevention. We will correlate the CSVD with the neurologic and     cognitive function as it is already proved in the general population. We will correlate the     CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap     screening tools for the CSVD in the HIV+ population.   "
82193|NCT02210117|"     Objectives:      Primary Objective:      Safety and tolerability of therapy with nivolumab vs. nivolumab + bevacizumab vs. nivolumab +     ipilimumab in Metastatic Renal Cell Carcinoma (mRCC) in the context of presurgical or     prebiopsy therapy.      Secondary Objective:      To study immunological changes in tumor tissues and peripheral blood in response to nivolumab     vs. nivolumab + bevacizumab vs. nivolumab + ipilimumab in RCC therapy.      To assess the efficacy of presurgical nivolumab vs. nivolumab + bevacizumab vs. nivolumab +     ipilimumab therapy in RCC by evaluating objective response rate and progression free     survival.   "
82194|NCT02210104|"     The goal of this clinical research study is to learn about the safety of giving CD4+T cells     with ipilimumab and cyclophosphamide.      CD4+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,     and they are designed to find cancer cells and may kill them.   "
82195|NCT02210091|"     The study purpose is:        -  To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly          prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last.        -  To compare pharmacokinetic (PK) parameters to ADVATE.        -  To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes.        -  To evaluate safety and immunogenicity.   "
82196|NCT02210078|"     The goal of this clinical research study is to learn about the safety of giving cytotoxic T     lymphocytes (CTLs) to patients who have had a stem cell transplant. Researchers also want to     learn if these cells can help to control CMV.   "
82197|NCT02210065|"     The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)     can help control CMV when it reactivates (becomes active again) in patients who receive an     allogeneic stem cell transplant. Researchers also want to learn about the safety of giving     CTLs to patients who have had a stem cell transplant.   "
82198|NCT02210052|"     The goal of the study was to determine if patients undergoing radiofrequency neurotomy (RFN)     of lumbar facet joints that are adjacent to previously placed pedicle screws from a fusion,     would lead to an increase in the temperature of the pedicle screws.   "
82199|NCT02210039|"     The study is being done to test the feasibility and tolerability of a SECM imaging probe in     patients with Barrett's Esophagus (BE).      A total of 12 subjects will undergo SECM probe imaging while they are under conscious     sedation. Spiral SECM imaging will be performed continuously over a pre-determined length.     Patients will later be asked for their feedback.   "
82200|NCT02210026|"     The investigators propose to test the hypothesis that Seattle bubble nasal continuous     positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth     weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway     pressure.   "
82201|NCT02210013|"     The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian     women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The     investigators will collect data about ovarian reserve markers and also the results after     ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian     response after IVF stimulation between both groups.   "
82202|NCT02210000|"     This study is a randomized, double-blind, placebo controlled trial designed to confirm the     symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1     and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine     if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat administration improves     gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily     Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who     have documented abnormally slow gastric emptying and have symptoms consistent with     gastroparesis.      Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study     will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a     2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety     follow-up visit.   "
82203|NCT02209987|"     This study will estimate the absolute bioavailability of subcutaneously injected GS-5745,     characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after     subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation     of anti-GS-5745 antibodies after SC and IV administration.   "
82206|NCT02209948|"     The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles     improve progression-free survival in patients with glioblastoma included in this study,     randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and     residual disease or not, to receive an additional 6 cycles of temozolomide.   "
82207|NCT02209935|"     Background. Early rehabilitation programs (ERP) that include physical, occupational, and     speech therapies lessens debilitation and promotes return to previous physical and cognitive     functioning and have been successfully applied in adult intensive care units (ICUs). Despite     the fact that critically ill children with acute brain injury (ABI) are at increased risk of     life-long disability and stunted development, benefits of ERP for this group have not been     studied and are not standard of care in pediatric ICUs.      Objectives. The aims of this study are 1) To better understand current practices and barriers     to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with     ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that     ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be     superior compared to the usual care group.      Methods. The first task of this research program is to survey healthcare professionals     (physicians, nurses, allied health) and families of children in the ICU about their     hospital's resources, current practices, and barriers to ERP. This survey will be distributed     to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators     (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from     critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled     trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of     ICU admission and those in the usual care group will begin therapies when these services are     ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to     the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are     eligible. Therapy interventions are individualized for the child's clinical status. The     effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS)     pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical     and cognitive function as well as behavior. Other tests will be performed that assesses child     and family quality of life and length of hospital admission. Our outcome tests were chosen     because 1) They are the most important outcomes to families of children as surveyed in our     ICU and 2) They are outcomes that can be influenced by ERP.      Summary. This is the first and largest study designed to evaluate whether ERP improves     outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in     ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will     have superior adaptive and quality of life outcomes, outcomes important to families, without     increasing adverse events compared to patients in the usual care group.   "
82208|NCT02209922|"     Purpose:      The incidence of stroke in low-to-middle income countries is increasing .Balance impairment     and falling negatively impact function of stroke patients. Mobility is based on successful     postural control and about 30% of individuals with stroke are unable to ambulate without     assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor     recovery in neurological disease.This can be addressed through a tDCS intervention.      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined     with Biodex balance training on postural control in chronic stroke patients using laboratory     and clinical assessments. The following essential treatment components; a) active tDCS     stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance     training program.      To identify combinations effects of tDCS stimulation plus balance training . Hypothesis:     Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will     significantly improve stroke clients' balance and functional mobility.      Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions      Experimental: Arm 1      tDCS brain stimulation and simultaneous balance training      Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance     training(20 minutes) for 5 consecutive days.      No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance     training   "
82209|NCT02209909|"     Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus     formation. The purpose of this study is to assess the effects of preoperative continuation of     aspirin on platelet activation after off pump coronary artery bypass surgery.   "
82210|NCT02209896|"     The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external     components.      The system is intended for home care use. The chronic pain treatment is achieved by an     electrical stimulation of peripheral nerve fibers. The stimulation is set so that it     generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and     improving the quality of life for the patient.   "
82211|NCT02209883|"     COPD (Chronic obstructive disease ) is a condition of respiratory system failure seen     occasionally in elderly patients of society. Sevofluorane is a safe, volatile anesthetic used     considerably widely all over the world. Because respiratory functions and gas exchange became     impaired in COPD patients, the respiratory system excretion/washout of inhalational     anesthetic agents can be affected. In our study we aimed to investigate if there is a     relation between sevofluorane's washout time and the degree of COPD.   "
82212|NCT02209870|"     The quality of cardiopulmonary resuscitation (CPR) has been identified as an important     determinants for patient survival, yet many studies revealed poor CPR guidelines compliance     in real-life practice for both health care providers and lay persons. Common shortcomings     identified include an insufficient number of chest compression, too rapid lung inflations,     and too much hands-off time. The poor quality of CPR is associated with lower survival rate.     Besides, some other problems could be found during resuscitation, such as prolonged     intubation time, delayed first shock delivery or unsteady drug delivery interval. These     problems can't be blamed on the only person but the teamwork. Certain measurements could     improve the performance of the resuscitation team, such as audio prompt or checklist.      Methods proposed and improvised to improve the quality of CPR have included CPR assisted     devices, automatic driven devices or audio prompt system. However, some of these methods are     hardly incorporate with the original resuscitation process since it could be an extra     workload. Therefore, the investigators try to provide an digitized checklist combined with     visual and audio alarming system, which could not only minimize the workload of chart     recording but also remind the team to perform essential procedures in time.      Information gained from a video-recording evaluation system had been employed to improve the     resuscitation skills. The improvement of resuscitation quality also could be found through     video-recording after certain intervention. It can also avoid the interference of the     resuscitation and find out other harmful factors to CPR quality.   "
82247|NCT02209415|"     Follow-up after successful operative treatment of cancer in the esophagus, stomach or     pancreas in order to detect recurrent disease is a controversial topic.      This is because the methods and the consequence of following these patients is unknown.      Therefore the investigators will randomize these patients in to two groups:        1. One group of patients will be offered visits with a specialist surgeon in a outpatient          setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is          the current standard at our department.        2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same          intervals as the first group.   "
82213|NCT02209857|"     Rationale:      Prediction of prognosis in patients with breast cancer is important to determine the     indication for adjuvant chemo-, endocrine- and immunotherapy. Apart from the     clinicopathological parameters incorporated into the Adjuvant!Online predictive model, the     validated 70-gene signature MammaPrint® is predictive of outcome too. MammaPrint® is advised     in the current Dutch CBO guideline (2012) for hormone receptor positive, invasive ductal     breast cancer in individual cases when there is 'doubt' about the indication for adjuvant     chemotherapy based on traditional prognostic factors. In the present study MammaPrint® is     used in this CBO 2012 guideline defined group of patients as an additional test for     decision-making for adjuvant chemotherapy.      Objective:      To assess the impact of MammaPrint® on clinical decision making regarding the administration     of adjuvant chemotherapy in the CBO 2012 guideline defined group of hormone receptor positive     invasive ductal carcinoma patients when there is doubt about the indication for adjuvant     chemotherapy based on traditional prognostic factors. The influence of various factors and     the impact of MammaPrint® in predefined subgroups will be analyzed too. Data from a national     registry regarding adjuvant systemic treatment in patients with similar clinicopathological     characteristics in whom MammaPrint® was not used will be obtained to provide a control group.      Hypothesis:      In the group of patients where national guidelines advocate using systemic therapy but     doctors are ambivalent in treating patients with adjuvant chemotherapy, it is hypothesized     that using MammaPrint® as an additional test will change the indication for adjuvant therapy     in a substantial proportion of patients resulting in at least 10% less patients who receive     adjuvant chemotherapy. Thus, in the study group at least 10% less patients will receive     chemotherapy when compared to a contemporary group of patients with similar     clinicopathological characteristics but without using MammaPrint®      Study population:      Hormone receptor positive, invasive ductal breast cancer patients when there is doubt about     the indication for adjuvant chemotherapy based on traditional prognostic factors.      Study design:      This is a prospective multicentre impact study.   "
82222|NCT02209740|"     Renal outcome could be different after switching tenofovir to different antiretroviral     strategies, in case of renal toxicity. Therefore, it is necessary to evaluate the importance     of renal evolution in these patients, in terms of grade and time to renal improvement,     according to the different options after interrupting tenofovir. The aim of this study was to     explore the renal outcome after tenofovir according to new antiretroviral regimen.   "
82223|NCT02209727|"     Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose     administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.   "
82224|NCT02209714|"     The objective of the study is to obtain information about the safety and tolerability of BIIF     1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose     (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic     data.   "
82225|NCT02209701|"     Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin     and major metabolites in head and neck cancer and other cancer patients with solid tumors who     receive radiation therapy.   "
82226|NCT02209688|"     The objective of this study was to obtain safety and tolerability data and first     pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.   "
82227|NCT02209675|"     Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for     differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post     living donor liver transplantation (LDLT) .As each condition require different treatment   "
82228|NCT02209662|"     Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with     physician-selected standard of care treatment such as debridement, hydrogel or saline     irrigation, primary dressing, and offloading will be randomized into one of two groups, the     Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce     growth factors that can help in wound healing.   "
82229|NCT02209649|"     Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose     combination tablets with the separate Telmisartan and Lacidipine tablets.   "
82230|NCT02209636|"     The proposed research is a randomized-controlled trial to determine the effectiveness of     reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the     function of arteries in adults with moderate to severe chronic kidney disease (CKD). [COMIRB     13-0328] Additionally, it will determine phosphorus balance among adults with CKD and whether     there is a difference in phosphorus balance after three months of treatment with lanthanum     carbonate. [COMIRB 15-0384]   "
82231|NCT02209623|"     The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced     Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0     days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be     verified by medical record review when possible. There will be an emphasis on enrolling women     who have received Tdap before the current pregnancy, to the greatest extent possible.     Non-pregnant women who are receiving their initial Tdap will also be recruited.      Injection-site (local) and systemic reaction data will be assessed on the vaccination day and     during the 7 days following vaccination using either identical web-based or paper diaries,     depending on the preference of the study participant.      Pregnant women will be followed until delivery with comprehensive obstetric and neonatal     outcomes obtained from review of the electronic medical record.   "
82232|NCT02209610|"     A hallmark of patients with heart failure (HF) is premature fatigue which impairs their     quality of life and depicts a major source of morbidity. Premature fatigue may be attributed     to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or     b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e.     central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force     and power generating capacity and to a compromised ability to perform whole body activities     (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers     from the working muscle play a critical role in the development of both components of     fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during     exercise and thereby exaggerate the development of central fatigue. In contrast, muscle     afferents optimize muscle O2 delivery through the precise regulation of circulation and     ventilation during exercise and thereby attenuate the development of peripheral fatigue.   "
82233|NCT02209597|"     Determine bioequivalence between branded and generic bupropion extended release (XL) products     (and between generic products) at steady state in patients with major depressive disorder.   "
82234|NCT02209584|"     This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions     when added to standard clinical-pathological parameters in men with newly diagnosed prostate     cancer.   "
82235|NCT02209571|"     Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients     with age and gender-matched healthy adults in order to identify a disease-specific exhaled     breath pattern as well as to gain insight into pathophysiological and microbial contributions     to exhaled breath composition.   "
82261|NCT02209233|"     The purpose of this study is to determine the effect that receiving massage therapy     post-operatively has on reducing perceived anxiety and pain in urology patients. Secondarily,     the result of massage on patient satisfaction, length of hospital stay, and narcotic use will     also be studied.   "
82390|NCT02207556|"     In this study the investigators want to find out more about the addition of the antibiotic,     doxycycline, to standard anti-amyloid therapy in people with amyloidosis. The investigators     want to find out whether doxycycline improves the response to standard anti-amyloid therapy     and whether it causes any problems (side effects).   "
82236|NCT02209558|"     Sternal precautions are standard patient education protocol disseminated to post-operative     open heart surgery patients . While this best practice safety measure is widely distributed     to patients, the origin of said precautions is unknown. Statewide hospitals vary on their     parameters for sternal precautions using a myriad of restrictions, i.e. weighted activities,     biomechanical movements to be avoided. In addition, the medium in which sternal precautions     are taught varies, thus complicating patient adherence to these vital post-operative     measures.      The primary objective of this study is to use a randomized pre-post test design to compare     two different training procedures. One training group examines current standard of care     (providing verbal instruction using teach back and written sternal precautions). The second     training group provides subjects with visual depiction of sternal precautions, in addition to     standard of care. The study will analyze 30 and 60 day readmission rates for aforementioned     patients. Finally, the study will assess changes in behavior intentions from before training     to after training in both groups via behavioral analysis survey consisting of 8 questions.      Hypothesis 1: The investigators hypothesize that subjects provided with visual sternal     precautions, in addition to standard of care, will have a lower 30 and 60 day readmission     rate when compared to subjects in the standard of care group      Hypothesis 2: The investigators hypothesize that changes in behavior intentions toward     sternal precautions will be greater from before training to after training in the visual SPs     in addition to standard of care group than the standard of care only group.   "
82237|NCT02209545|"     The aim of this research work is to assess the impact of a single preoperative dose of buccal     misoprostol in reducing blood loss during abdominal fibroid surgery.   "
82238|NCT02209532|"     This is a randomized, prospective, open label, multicenter study to assess the safety and     utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph     nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.   "
82239|NCT02209519|"     Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with     metronidazole or placebo to compare the rates of recurrent BV in the women   "
82240|NCT02209506|"     The purpose of this study is to evaluate the safety and tolerability of single and multiple     oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.   "
82241|NCT02209493|"     In light of the high CVD morbidity and mortality, promoting simple interventions to improve     serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases.     Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species)     are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol     control. However, the literature documenting their purported hypocholesterolemic potential is     scarce. Given the unique composition and potential benefits of nopales, their use may be an     ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.     Therefore, the aim of this study is to evaluate the efficacy of a 2-week intervention with     nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison     to a control food with lower antioxidant and fiber content (cucumber) among adults with     moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited     data exists on the effects of nopales supplementation on other factors associated with     cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity,     inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL     oxidizability and total antioxidant capacity) will also be conducted.   "
82242|NCT02209480|"     This study aimed to test the efficacy of five Alexander Technique lessons compared to the     same period of heat pad application and guided imagery in patients with chronic non-specific     neck pain.   "
82243|NCT02209467|"     The study hypothesis is that for people with moderate to severe multiple sclerosis postural     balance and walking improve and the risk of accidental falls are reduced after participating     in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain     a further 7 weeks post training.      Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural     balance are often affected early in the course of the disease. The risk of falls is large.     Many persons with MS have decreased trunk stability compared to healthy persons . In an     earlier study including people with mild to moderate MS we found that a period of core     stability exercises reduced the risk of falls. In this study the training concept will be     applied for persons with more severe walking limitations.   "
82244|NCT02209454|"     The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an     Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In     addition, this study intends to evaluate the safety and tolerability of Test and Reference     formulations.   "
82245|NCT02209441|"     -  To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of          sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as          first-line treatment for advanced gastric cancer        -  The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide          elevation of the sorafenib dosage to the next level   "
82246|NCT02209428|"     Low grade gliomas (LGGs) are the most common primary central nervous system malignancies.     Brain surgeries with the most possible extent of resection are endeavored to achieve longer     survivals in LGG patients. For patients with tumor located in eloquent areas so that gross     total resection is not applicable, National Comprehensive Cancer Network (NCCN) 2013     guidelines assigned both radiotherapy or chemotherapy as adjuvant treatments of low grade     glioma following surgeries. Retrospective studies have suggested that temozolomide (an oral     chemotherapeutics) chemotherapy have good effects on the control of tumor progression or     recurrence in LGG patients after surgeries, especially in those with isocitrate dehydrogenase     (IDH) gene mutations.      Therefore, our prospective cohort study is to provide a higher level(IIb) of evidence for the     correlation between IDH mutation and the responsiveness to up-front adjuvant metronomic     temozolomide chemotherapy in young patients with LGG located in eloquent brain areas. And     hopefully justify future RCTs with comparison between effects of adjuvant radiotherapy and     chemotherapy in these patients.   "
82248|NCT02209402|"     Chronic kidney disease (CKD) is a prevalent disorder and a major health concern.     Cardiovascular disease is the most prevailing and life-threatening complication observed in     patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk     level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are     more likely to occur than the evolution to final stages of kidney disease with the need for     dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not     affect cardiovascular prognosis in CKD, which suggests that the missing link between these     two entities has not been elucidated yet.      In the present project, the investigators focus on endothelial dysfunction in patients with     CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the     absence of structural changes, endothelial dysfunction is still reversible, which offers     therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage.      The purpose of this study is to determine whether an exercise training program is effective     in ameliorating endothelial dysfunction in patients with chronic kidney disease.   "
82249|NCT02209389|"     The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in     asymptomatic women for whom screening or diagnostic mammography findings are normal or benign     (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3     or 4). The device is intended to increase breast cancer detection in the described patient     population. Based upon the result of OctavaPink, the patient will be further evaluated by     their physician.   "
82250|NCT02209376|"     An Open-Label Phase 1 Pilot Study to determine the safety and feasibility of CART-EGFRvIII     (autologous T cells transduced with a lentiviral vector to express a chimeric antigen     receptor specific for EGFRvIII) in the treatment of patients with EGFRvIII+ glioblastoma who     have had their first recurrence as determined by standard imaging or have have residual     disease after initial resection.   "
82251|NCT02209363|"     Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's     disease (PD), often progresses to dementia, and profoundly affects quality of life.     Obstructive sleep apnea (OSA) is a common disorder in the general population that is     treatable with positive airway pressure (PAP) therapy. It is known to impair cognitive     function, but whether treatment improves cognitive function is less clear. When already     affected by a degenerative process like PD, the brain might be more vulnerable to the effects     of OSA, and more responsive to OSA treatment. To date, OSA has not been recognized as a     significant factor in PD. In preliminary work in PD patients, the investigators have found an     association between OSA and poor cognition, and cognitive improvement with PAP therapy. The     investigators now wish to more rigorously evaluate the effect of OSA treatment on cognitive     function in PD in a randomized controlled trial. The investigators primary objective is to     assess, in PD patients with OSA and cognitive deficit, the effect of OSA treatment on global     cognitive function. The investigators will also assess other non-motor symptoms of PD,     quality of life, and specific domains of neurocognitive function. PD patients will be     recruited from the McGill Movement Disorders Clinic and other Quebec Parkinson Network     Centres. Participants will need to have evidence of cognitive deficit and presence of OSA on     screening diagnostic polysomnography (sleep study). Ninety subjects will be randomly assigned     to PAP or nasal dilator strips. Detailed neuropsychological testing and other measurements     (including quality of life) will be done at baseline, 3 months and 6 months. At the end of     the study period, subjects will have polysomnography on their respective treatment to assess     efficacy with respect to OSA treatment. This study may demonstrate that a non-pharmacologic     intervention has the potential to have a marked beneficial impact on cognitive function and     quality of life in a significant proportion of PD patients.   "
82252|NCT02209350|"     The aim of the study is to compare effectiveness and long-term results of aorta-femoral     reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC     C,D).   "
82253|NCT02209337|"     A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and     performance of the SRS (Lyra Medical) vaginal mesh in POP patients   "
82254|NCT02209324|"     A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151     in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes     and Kaposi varicelliform).   "
82255|NCT02209311|"     Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in vitro.Tissue     engineered construction will be created using synthetic tricalcium phosphate and autologous     MMSCs. Patients will undergo sinus lift procedure with implantation of created     tissue-engineered construction. This is a single arm study with no control. All patients     receive cell therapy.   "
82256|NCT02209298|"     This observational study is intended to collect real-world (post-approval use) data regarding     the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter     Aortic Valve Implantation (TAVI).   "
82257|NCT02209285|"     Patients with vascular and multiple chronic conditions (MCC) move between multiple care     settings, and so they are at high risk of receiving fragmented care leading to increased risk     for avoidable illness, death, and health care costs. Recent Canadian studies and reports     identify significant gaps in the delivery of effective care to patients with multiple chronic     conditions in community-based settings.      The overall goal of the program is to promote successful management of chronic conditions,     enhance quality of life, reduce the on-demand use of expensive health services and support     primary caregivers (i.e. family or friends) who provide physical, emotional or financial care     to an older adult with vascular conditions and MCC. This research program will leverage the     tremendous potential to reduce the burden of vascular and vascular-related diseases by     enhancing community-based prevention and chronic disease management.      This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of     an interprofessional intervention on health-related quality of life (HRQOL), depression,     anxiety, physical functioning, and the costs of use of health services for stroke survivors     with MCC receiving home care and their family caregivers. The results will inform: (1) the     development of national standards for community-based care for patients with multiple chronic     conditions and (2) the development of a new and innovative community-based model for the     management of multiple chronic conditions that can be scaled up and spread across Canada.   "
82258|NCT02209272|"     Local anesthesia is commonly used to reduce pain during joint injections, particularly for     deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most     medical practices. It is well known that lidocaine infiltration itself is painful. Many     strategies have been studied to minimize pain associated with lidocaine administration,     including buffering, warming, and slowing infiltration rate. Bacteriostatic saline (BS) is an     alternative local anesthetic that has been shown to be less painful when injected into     subcutaneous tissues compared with lidocaine. However, BS use has not been widely implemented     for local anesthesia, and it has not been studied in the context of joint injections. The     purpose of this study is to compare infiltration pain and anesthetic efficacy between     lidocaine and BS for ultrasound (US) guided intraarticular hip injections.   "
82262|NCT02209220|"     Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction     of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation     and sleep micro-arousals. In surgical patients, OSA is a well-known risk factor for     perioperative complications. At Institut Universitaire de cardiologie et de Pneumologie de     Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year.     Consequently, the identification and management of OSA in this high-risk surgical population     is an essential part of practice. Actual guidelines recommend that treatment for OSA be     initiated before the surgical procedure. Presently, the first line treatment for OSA is     continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously     to maintain the patency of the upper airways. However the compliance to this therapy is poor.     An available alternative is automatic positive airway pressure (APAP) which delivers a     variable amount of pressure to prevent reduction in airflow that accompanies upper airway     obstruction. The APAP delivers the lowest pressure needed to prevent upper airways collapse.     APAP significantly reduces the mean level of pressure delivered in comparison to conventional     treatment. Theoretically, it seems logical that applying the lowest pressure necessary would     allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials     comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling     obstructive events. APAP would be a valuable alternative if it was not for its excess cost.     However, APAP improves compliance to treatment in two types of population: poor compliant     subjects and those needing high pressure levels. The investigators know that compliance to     positive pressure is poor in patients without excessive daytime sleepiness, which represents     the majority of patient waiting bariatric surgery. Moreover, in patients needing levels of     pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects     and improves quality of life. The review of 180 files of OSA patients treated by CPAP who had     bariatric surgery in our center in 2012 demonstrated that the majority of patients needed     high level pressure. These values suggest that APAP could improve treatment compliance in     apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and     they generally require high positive pressure level.   "
82263|NCT02209207|"     This study will investigate the effects of interval walking training versus continuous     walking training in patients with chronic obstructive pulmonary disease. Patients will be     recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized     to one of the two intervention groups. All walking training sessions will be performed on the     same treadmill. Walking intensity in the continuous walking group will be 60 percent of the     average speed of the 6-minute walking test. Patients in the interval training group will     perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds     alternating with 60 seconds of rest. The total exercise duration will be progressively     increased from 10 to 32 minutes.   "
82264|NCT02209194|"     The purpose of the study is to evaluate the clinical and technical success as well as safety     and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or     bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with     primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac     implantation side.   "
82265|NCT02209181|"     To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232     at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen     1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain     relief effectiveness up to 6 hours after administration of the study drug.   "
82266|NCT02209168|"     The aim of this study is to confirm the difference in ovarian reserve markers and serum     vitamine D levels between infertile indian, arabian and caucasian population.   "
82267|NCT02209155|"     This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate     the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.   "
82268|NCT02209142|"     Depression is a leading cause of disability worldwide, affecting nearly 16% of the general     population. Its physiopathology remains unclear. Based on gene-environment studies and     epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE)     results from the convergence of multiple factors including biological factors such as     multi-genic vulnerability, hormonal and immunological variations as well as environmental     factors. As a consequence, mRNA could define a biological signature of the MDE.   "
82269|NCT02209129|"     Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation)     will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo)     of both breasts in two views in order to investigate the additional value of tomosynthesis in     the diagnosis of breast cancer.   "
82270|NCT02209116|"     Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health     disorders of childhood. Children with ADHD often have poor attention, are restless and     hyperactive and show impulsive behaviour.      It is important to detect ADHD so young people can have access to appropriate clinical     interventions.      One of the most common ways ADHD is assessed is through the clinician's opinion; however,     this can vary between clinicians and is thought to be one reason why ADHD may be     mis-diagnosed. Using a more objective computer tasks may help improve our understanding of     ADHD. One computer task is the QbTest.      The test presents different symbols to the child, and the child has to respond by pressing a     button only when a target symbol appears. The test measures the child's attention,     impulsivity and movement whilst doing this task.      Although the test is thought to be a valid measure, more research needs to be conducted on     this measure to see whether it helps clinicians decision making.      To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication     decisions, children and young people will be asked to complete the task as part of their     initial assessment for ADHD. Half the participants and their clinician will have access to     the QbTest result; the other half will not have access to the QbTest result until the end of     the study.      Participant's parents, teachers and the clinician will also be asked to complete some     questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD     and is given medication they will be asked to complete the task again on medication. The same     set of questionnaires will be completed by the parents/teachers/clinicians.      The entire sample will be followed up at 6 months and asked to complete the questionnaires.   "
82271|NCT02209103|"     This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can     improve objective sleep duration and/or quality, and/or improve perceived sleep quality and     feelings of rest.      Participants will complete a total of 9 test nights, which consist of sleeping with the sleep     monitoring system after ingestion of the test product or a placebo, and filling out     sleep-related questionnaires.      The study has a crossover design, meaning that all participants receive all three     interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a     randomized order.   "
82407|NCT02207335|"     Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme     in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with     capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with     small sample.   "
82272|NCT02209090|"     Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions     in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant     women with epidural anaesthesia.      Design: An open, randomised, controlled and parallel clinical trial will be conducted at the     Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona,     Spain.      Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be     selected. Each woman will be assigned to a control or experimental group via an opaque     envelope at a 1:1 ratio.      The control group will deliver in free intrapartum positions, and the experimental group in a     modified Sims position. Correction of foetal position is the key study variable, and delivery     type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.   "
82273|NCT02209077|"     This single-center, prospective, interventional clinical study is conducted to evaluate the     repeatability and reproducibility of structural parameters of the optic nerve head, the     peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT     (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study     are compared to those from a previous, larger healthy volunteer study that was conducted in     the United States and Europe (S-2012-1), and data from glaucoma patients are compared to     those from the healthy volunteers.   "
82274|NCT02209064|"     Prospective non-randomized, single arm trial to further evaluate the safety and performance     of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial     space during epicardial diagnostic or therapeutic (ablation) procedures.   "
82275|NCT02209051|"     The primary goal of the study is to demonstrate the increased rate of complete wound closure     by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers   "
82276|NCT02209038|"     There is a large gap between the care seriously ill patients want and the care they receive.     Advance directives (ADs) offer an opportunity for patients to express specific end-of-life     preferences to avoid unwanted care. As promising as ADs may be for improving the quality of     care near the end of life, rates of AD completion remain low and previous efforts to     encourage their completion have had limited success. Principles of behavioral economics, such     as the effects of defaults and other framing effects, may offer a novel approach to bridge     the gap in end-of-life care. The goal of this study is to test whether the framing effect of     expanding choice sets can increase the completion of and specification of choices within     advance directives.   "
82277|NCT02209025|"     Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein     (LDL) cholesterol concentrations, a substantial residual cardiovascular risk remains. An     additive strategy to further lower this residual risk may be via raising high-density     lipoprotein (HDL) concentrations, and in particular those of its major protein constituent     apolipoprotein A-I (apoA-I). Based on several studies, theobromine may be a promising     candidate in this respect. Recently, theobromine was shown to increase serum HDL cholesterol     (HDL-C) concentrations by 0.16 mmol/L or 10% and apoA-I levels with 8%. The question is     whether this increase in HDL-C and apoA-I concentrations observed translates into an improved     functionality of the blood vessels. Effects of theobromine on vascular function have never     been evaluated in a placebo controlled human intervention study.      Objective: The primary objective is to evaluate the long-term effects of theobromine on     vascular function in healthy subjects with a slightly lowered HDL-C in the fasting and the     postprandial state. The second primary objective is to evaluate the long-term effects of     theobromine on intestinal apoA-I mRNA and protein expression levels in healthy subjects with     a slightly lowered HDL-C in the fasting and the postprandial state.      Secondary objectives are to study the long-term effects of theobromine on (1) fasting serum     HDL-C concentrations, (2) cholesterol efflux capacity and (3) postprandial lipid and glucose     metabolism.      Study design: A randomized, double-blind, placebo controlled cross-over design. The total     study duration will be 12 weeks, consisting of a 4 week experimental period, a 4 week     wash-out, and a 4 week control period. At the end of the experimental and control periods, a     postprandial test will take place.      Study population: Forty-eight healthy men aged 45-70 years and women aged 50-70 years, with     slightly lowered HDL-C concentrations (men <1.3 mmol/L and women <1.5 mmol/L).      Intervention: During the experimental period, subjects will consume daily at breakfast an     drink containing 500 mg theobromine. During the placebo period, the subjects will consume     daily at breakfast the same drink without theobromine. During the wash-out period, they will     not consume any of the drinks.      Main study parameters/endpoints: Measurements will be performed at the end of both 4-week     intervention periods. The effects of theobromine will be calculated as the absolute     differences between values obtained at the end of each period. The primary endpoint is the     change in vascular function defined as % change in flow-mediated dilation (FMD) after intake     of a daily stressor, a milkshake providing all the three different macronutrients. The second     primary endpoint is the change in apoA-I mRNA and protein expression on the end of each     period 5 hours after intake of the milkshake.   "
82278|NCT02209012|"     The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in     subjects with multiple actinic keratosis of the upper extremities who received treatment as     part of the DUSA CP0108 study.   "
82279|NCT02208999|"     Assessing the long-term efficacy, complications, revision rates and final explantation of the     device   "
82280|NCT02208986|"     The aim of this randomized single center study is to explore the most optimal dose of GnRHa     used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte     donors who have GnRHa trigger as a standard trigger concept.      Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa     will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality     embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of     the dose of GnRHa used for trigger.   "
82281|NCT02208973|"     To assess the safety and tolerability of five doses of PBF-680 (5 mg, 10 mg, 20 mg, 40 mg and     60mg) after repeated (8 days) single daily oral dose administration in young male and female     healthy subjects.   "
82282|NCT02208960|"     Each year, more than 3 million neonatal deaths occur worldwide and greater than 200 million     children under the age of 5, almost all in low- and middle-income countries, are not     fulfilling their developmental potential. The development of the growing brain can be     affected through multiple mechanisms including the same insults that are major causes of     mortality, namely hypothermia and infection. The first month of life is a crucial period in     neurodevelopment (ND). In this study, the investigators propose the home-based use of an     integrated evidence-based toolkit to improve health status, reduce the incidence of neonatal     insults that may affect brain development, decrease neonatal mortality rate (NMR), and     provide early identification of danger signs. The investigators hypothesize that use of the     neonatal toolkit will result in an improvement of at least one standard deviation in     neurodevelopment as measured at 12 months of age by the Protocol for Child Monitoring Infant     and Toddler (PCM-IT) version.   "
82373|NCT02207777|"     For this purpose, we will compare the effects of 16-18% weight loss induced by Roux-en Y     Gastric bypass (RYGB) surgery, biliopancreatic diversion with duodenal switch (BPD), or     sleeve gastrectomy (SG) surgeries with the same weight loss induced by laparoscopic     adjustable gastric banding (LAGB) or a low-calorie diet (LCD) on liver and skeletal muscle     insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects     with T2D.   "
91101|NCT02093650|"     Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate     to severe menopausal symptoms   "
82283|NCT02208947|"     The specific aims of the project are: 1) to test the effectiveness of consumer-directed     financial incentives paired with provider-directed financial incentives, compared to     provider-directed financial incentives alone, for increasing advance care planning (ACP)     among Medicaid beneficiaries; and 2) to assess perceptions regarding the appropriateness of     consumer-directed financial incentives for ACP among study participants. The investigators     hypothesize that consumer-directed financial incentives will result in a 15-percentage point     absolute increase in the proportion of subjects completing ACP. The investigators do not     advance hypotheses about the qualitative component.   "
82284|NCT02208934|"     Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg,     10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers   "
82285|NCT02208921|"     This non-interventional, multi-centric, cross-sectional study is aimed to determine the     prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000     patients will be enrolled from 30 investigative sites all over the country. Each     investigative site will be expected to enrol 100 subjects. All the procedures will be     completed in a single day.   "
82286|NCT02208908|"     The purpose of this study is to measure the impact of training on the practical assessment     and management of the oral status of patients hospitalized in palliative situation.   "
82287|NCT02208895|"     Pleural fluid glucose levels measured with bed-side point of care methods such as finger     stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.   "
82288|NCT02208882|"     The purpose of this study is to assess the safety, tolerability and effect on Midazolam     pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.   "
82289|NCT02208869|"     True prevalence of FH in the Russian Federation is unknown which leads to low percentage of     diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific     diagnostic algorithms and optimal treatment strategies. The main aim of the present study is     to evaluate the extent to which FH is underdiagnosed and undertreated in the Russian     Federation for reduction of cardiovascular risk related to atherosclerosis in the country.      As a first step, total cholesterol (TC) and low-density lipoprotein (LDL-C) levels will be     determined in a random sample from Moscow population (n=18000). It is expected that TC ≥ 7.5     mmol/L will be detected in 10% of cohort. During 2014, approximately 500 patients will pass     through non-invasive clinical examination at the Russian Cardiology Research and Production     Center, including patient demographics, past medical history, family history of     hypercholesterolemia, physical findings, current lipid-lowering therapies, blood tests,     genetic analysis, echocardiography, carotid duplex ultrasound and exercise SPECT imaging in     selected cases. On the basis of the Moscow Program four major Federal Medical Centers will be     involved, and FH Registry will be created as a national, multi-center initiative to screen FH     patients, control their diagnosis and management, and track clinical-reported outcomes over     time.      Establishment of National Guidelines for the diagnosis and treatment of FH on the basis of     these data and implementation those into clinical practice in different regions of Russia     will allow improving patient care. As an expected outcome, this program will raise awareness     and increase appropriate assessment and treatment of FH patients in Russia, leading to a     timely detection of the disease and therapy initiation.   "
82290|NCT02208856|"     To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single     doses, with and without a 64 g fat breakfast at one selected dose.   "
82291|NCT02208843|"     The objectives of this single-arm, open-label trial are to assess the efficacy and safety of     afatinib as second line treatment for patients with locally advanced or metastatic non-small     cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line     platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to     the results seen in previous trials.   "
82292|NCT02208830|"     The hypothesis of this study is that the group of patients who will carry out the     rehabilitation program associated with respiratory therapy will have higher benefits in     physical function, peripheral muscle strength and quality of life compared to the group that     will only perform chest physiotherapy. Additionally, there will be a negative correlation     between inflammatory mediators and measures of physical ability as well as the magnitude of     improvement is lower after treatment in patients with higher baseline levels of inflammation.   "
82293|NCT02208817|"     2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies     in recognising and managing sick children. Key recommendations from both reviews included the     development and adoption of 'track and trigger' or a paediatric early warning score (PEWS) to     better identify the sick or deteriorating child. PEWS tools offer the potential to identify     and respond sooner to clinical deterioration. Capillary refill time (CRT) is a measure of     skin blood flow and is a vital part of many early warning and resuscitation scores. It is a     sensitive marker of infection and dehydration in children. However, due to how it is     performed and interpreted CRT is prone to marked variability between observers.      We have Medical Research Council (MRC) funding to develop an automated capillary refill     device and user interface to provide a paediatric continuous early warning (PaedCEW)     monitoring system. The PaedCEW system would complement and support current clinical practice     and aim to address the difficulties of recognising ill children.      We aim to recruit 20 ill children on the Paediatric Intensive Care Unit (PICU) with 2 matched     controls without significant illness from the Nottingham Children's Hospital. The 20 ill     children will have their CRT (and PaedCEW score) monitored before, during and after admission     to PICU. This will allow correlation with invasive (BP, central venous oxygen saturations,     lactate) and noninvasive (CRT, heart rate, cardiac output) measures of cardiovascular status     during periods of stability and compromise. Matched controls will be monitored for around 24     hours. This pilot study will allow development of our system.      This is a proof of concept study. This study aims to demonstrate a novel device for measuring     CRT. Its correlation with noninvasive measures of cardiovascular status will enable a     pragmatic comparison with current clinical practice. In addition, correlation with invasive     measures of cardiovascular status will enable us to calculate sensitivity, specificity,     negative predictive value (NPV) and positive predictive value (PPV).   "
82294|NCT02208804|"     The objective of the SIM trial is to investigate whether using the Surefire Infusion System     during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity     concentration ratio, compared with using a standard end-hole microcatheter.   "
82295|NCT02208791|"     The purpose of this study is to determine the effects of sirolimus in the phenotype of     peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory     phenotype and in the development of anti-HLA antibodies among kidney transplant recipients     with high immunological risk for graft rejection.   "
82408|NCT02207322|"     The main purpose of this study is to assess whether early integration of palliative and     supportive care services in care of patients hospitalized for hematopoietic stem cell     transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.   "
82296|NCT02208778|"     Osteoarthritis (OA) is a degenerative joint disease and is the most common form of arthritis.     Pain reduction and functional recovery are the key elements of the clinical management of OA.     Current treatment guidelines recommend a combination of pharmacological and     non-pharmacological treatments. However, these are not always effective, with nearly 20% of     patients not responding to any standard therapy, including joint replacement.      The mechanisms of pain relief are not well understood and are complicated by the remarkably     large placebo effect, and inter-individual variation. There is no objective criteria for     predicting whether a patient will respond to a given treatment      Duloxetine, an antidepressant drug, has proven effectiveness in various chronic pain     syndromes including knee OA. The effect is however limited and only clinically relevant in     around half of the trial patients. Importantly, it is currently unclear how and in whom     duloxetine alleviates chronic pain.      Advanced MRI techniques use strong magnetic fields and radio frequency signals to generate     metabolic, anatomical and functional brain images (fMRI).      Remifentanil is a potent analgesic agent whose analgesic effect has been well characterised     in healthy volunteers, including fMRI studies showing modulation of activation of regions in     the brain related to pain processing. Nevertheless, the neural correlates of remifentanil     effects have not yet been investigated in chronic pain patients.      The aim of this research is to use a combination of multimodal MRI, genetic and psychometric     assessments to identify the mechanisms of pain relief in knee OA patients, following     treatments with duloxetine and remifentanil, in a placebo controlled condition. With this we     also aim to identify genetic, anatomical and brain activity predictors of treatment outcomes.      The main hypotheses are:        -  Analgesic response to duloxetine treatment can be predicted using a range of baseline          brain imaging markers and QST.        -  Analgesic response to duloxetine is mediated by modulation of neural networks          underpinning emotional control.        -  Duloxetine-induced changes in brain activation differ between responders and          non-responders.      This study is expected to last for two years. It is funded by Arthritis Research United     Kingdom and forms part of a wider scientific investigation, using translational     methodologies, to enhance the understanding of arthritis pain and to improve its treatment.   "
82297|NCT02208765|"     Endothelial dysfunction has been demonstrated to be an early marker of coronary artery     disease (CAD). On the other hand, myocardial perfusion single photon emission computed     tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or     known CAD.      Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate     marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive     and independent prognostic value over the presence of myocardial ischemia remain unknown.      Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial     perfusion heterogeneity assessed by a new automatized image processing method applied to     routine MP-SPECT.      The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive     of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for     routine evaluation of known or suspected CAD.   "
82298|NCT02208752|"     This is a randomised controlled study involving a group of 20 patients- 10 patients in a     control group, 10 patients in treatment group. The treatment group consists of exercises with     theraband for the shoulder and exercises of motor control of the scapula. The purpose of the     study is to measure the effects of a pre-operative physiotherapy program for patients awaitng     for rotator cuff surgery, The duration of the pilot project is 4 weeks.   "
82299|NCT02208739|"     Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic inflammatory     disease of the periodontium which results in irreversible destruction of supporting     structures of the teeth such as periodontal ligaments, connective tissues, cementum and     alveolar bone. More than 700 species of bacteria are estimated to be found in the     sub-gingival dental biofilm in which periodontopathogens are found to be responsible in     initiating periodontal disease. Chronic periodontitis, although termed as 'chronic', starts     as an acute inflammation. Low levels of bacteremia and endotoxins provides a stimulus for the     systemic inflammatory response. In periodontitis, the interaction of lipopolysaccharide (LPS)     from gram-negative bacteria with host cells initiates the secretion of cytokines and the     expression of cell adhesion molecules in gingival tissue which leads to loss of alveolar bone     and connective tissues supporting the teeth.      In the management of chronic periodontitis, non surgical periodontal therapy (NSPT) which     includes oral hygiene instruction (OHI), scaling and root planing, is administered to improve     clinical parameters as well as controlling the bacterial count responsible in initiating the     disease and the resultant inflammatory response. Success of the treatment can be analyzed     when the clinical parameters, counts of the microbes is reduced and inflammatory response is     controlled. Studies which have evaluated the microbiological and immunological response     following NSPT clearly demonstrates an improvement in clinical parameters, reduction in     inflammatory mediators present as well as a decrease in microbial count.      OHI which includes tooth brushing and inter-dental cleaning is found beneficial in removing     microbial plaque, thus, preventing periodontal diseases such as gingivitis and periodontitis.     Studies have evaluated the role of OHI on clinical and immunological parameters and     microbiological profiles of periodontal maintenance subjects, while none of them evaluated     its role alone in the management of chronic periodontitis subjects. Therefore, the purpose of     the following investigation was to compare the changes in the clinical parameters,     inflammatory mediators as well as level and frequency of detection of periodontopathogens     that take place after 3-months of NSPT versus OHI and to evaluate if clinical parameters have     an effect on these inflammatory mediators and microbiological changes.   "
82300|NCT02208726|"     Increased levels of stress and anxiety are experienced by many students. Stress can have a     negative influence on academic outcome and performance, as well as on the student's mental     health. Conventional treatment options for anxiety include counseling, as well as anxiolytics     and antidepressants, which may have various adverse effects. Picricum acidum and Phosphoricum     acidum are homeopathic remedies that may be helpful in alleviating anxiety in students;     however there has been no research done to date to show their efficacy for this condition.      The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum     Homaccord on perceived levels of anxiety in university students, by means of the     State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.   "
82301|NCT02208713|"     Facioscapulohumeral Dystrophy is a Autosomal dominant inherited dystrophy with the prevalence     of 1:20,000 and it is the third most common dystrophy after the dystrophinopathies and     myotonic dystrophy. The symptoms including: Pain, facial weakness, scapular fixator, humeral,     truncal, pelvic girdle and lower-extremity weakness, High frequency hearing loss, Retinal     telangiectasia . The existing treatments are not effective so, cell therapy is a new hope to     improve patients' quality of life. Therefore, We design this clinical trial to evaluate the     safety and feasibility of stem cell transplantation.   "
82302|NCT02208700|"     Patients with mechanical ventilation have shown improved weaning rates when enteral tube     feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.      LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical     ventilation, decreased mortality rates and decreased organ failure when fed an enteral     product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral     nutrition product.   "
82303|NCT02208687|"     Fatigue is present in at least 60% of the patients with a muscle disease and can be the most     disabling symptom. In combination with other impairments, this often results in low levels of     physical activity and decreased social participation, leading to large societal costs.     Energetic is a self-management group program aimed at improving participation and physical     endurance in these patients. Our hypothesis is that Energetic results in improved     participation and improved physical endurance, less experienced fatigue and better quality of     life compared to usual care, without increasing health care costs.   "
82409|NCT02207309|"     This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients     with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment     including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional     hyperthermia.   "
82304|NCT02208674|"     Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased     risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized     clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and     hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is     screened and treated according to recommended guidelines. Using a cluster-randomized,     controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize     6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a     pharmacist-directed CKD Action Plan (group 2). Determining the impact of the CKD Action     Plan on screening and treatment guideline adherence is the primary goal of this pilot study.   "
82305|NCT02208661|"     Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal     recessive genetic lysosomal storage disorder. Research thus far regarding Morquio, has     primarily focused on the physical aspects of the various diseases. Less attention has been     paid to the psychological toll of these diseases, whether they are direct symptoms or     reactions to living with a chronic progressive disease.      Prior to 2013, there was neither a cure nor treatment (other than palliative) for Morquio     disease. In the latter half of 2013, ERT became available to the broader population of     patients with Morquio A disease through BioMarin's Expanded Access Program.      In a previous study, entitled Psychological Concomitants of Morquio syndrome the present     investigator enrolled 20 adult subjects with Morquio into a pilot study to estimate a     baseline incidence of psychological symptoms and overall quality of life. Subjects were all     over the age of 18. Data from this study were published in 2015.      The present study extends this research into psychological health with Morquio via a     comparison of psychological issues and quality of life before and after treatment (i.e. ERT).     As ERT does not cross the blood-brain barrier, it would be unlikely to improve organic     psychological symptoms, but may improve any reactive psychological symptoms caused by living     over time with this chronic progressive genetic disease.      The present study thus seeks to follow adult patients with Morquio A disease as they begin     ERT and track their psychological health every 6 months for a duration of 2 years. Adult     patients with Morquio disease are invited to participate. Subjects will complete three     different self-report questionnaires, the Achenbach System of Empirically Based Assessment     (ASEBA) Adult Self-Report (ASR), the Short Form 36-item Health Questionnaire (SF-36), and the     Brief Pain Inventory (BPI). Group aggregate data will be reported; individual questionnaire     content and results will be held confidential, except as in accordance with Georgia law     relating to reporting of child or elder abuse, suicidal and/or homicidal intent.   "
82306|NCT02208648|"     The study will investigate whether the presence of coronary artery calcium as demonstrated on     pre-operative, thoracic staging Computed Tomography (CT) is an independent risk factor for 90     day mortality in patients undergoing major abdominal surgery.      The study research question: Do higher levels of coronary calcification correlate to an     increased risk of post-operative mortality in patients undergoing major abdominal surgery?   "
82307|NCT02208635|"     The objective of this study is to compare the quantity of Zn absorbed from an accurately     weighed quantity (~100 g) of minimally milled control maize (~15 µg Zn/g maize), from     biofortified maize (~30 µg Zn/g) and from the same control maize that has been fortified     (total level of ~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual     food staple is maize.   "
82308|NCT02208622|"     Bioavailability of iron and zinc from habitual plant-based diets consumed by young children     in Mexico is low due to the high phytate content. Whey protein has been found to increase     zinc absorption, thus, providing a whey based supplement with micronutrients may be an     effective strategy to increase iron and zinc bioavailability from plant-based foods and     alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron     in children receiving diets with and without whey protein supplements (WPS).   "
82309|NCT02208609|"     Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets     and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common.     Supplementation of Zn to children during diarrhea episodes has been shown to diminish     duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this     diet might play a role in these processes. Supplementation of this micronutrient in the diet     might be beneficial. The investigators will compare absorption of Zn from white maize     tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool     children in Guatemala.   "
82310|NCT02208596|"     To explore the feasibility of different doses of etomidate admixed with propofol in induced     abortion: a randomized, double blind controlled trial.   "
82311|NCT02208583|"     To explore the molecular phenotypic changes and personalized treatment in     castration-resistant prostate cancer.   "
82312|NCT02208570|"     The purpose of this study is to find out the predictability of the pulse pressure variation     during spontaneous ventilation on the incidence of hypotension during induction of     anesthesia.   "
82313|NCT02208557|"     Background: Development of an incisional hernia is one of the most frequent complications of     midline laparotomies requiring reoperation. This paper presents the rationale, design, and     study protocol for a randomized controlled trial, the aim of which was to evaluate the     efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for     reinforcement of a midline fascial closure.      Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh)     is a multicenter randomized controlled trial in which adult patients undergoing elective or     urgent open abdominal operations through a midline laparotomy incision are assigned to one of     two groups based on the laparotomy closure procedure: an intervention group in which a     continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE®     BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA), or     a control group with continuous PDS suture only. Both groups are followed over 6 months.      Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical     examination at clinical visits and radiologically (CT scan) performed at the end of     follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma,     burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate     that suture plus prosthetic mesh insertion for routine midline laparotomy closure is     effective in preventing incisional hernias after open abdominal surgery, to avoid the effects     on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life,     and to save costs potentially associated with incisional hernia surgical repair.   "
82314|NCT02208544|"     The purpose of this study is to determine whether the use of molecular imaging using     FDG-PET/CT could prevent unnecessary diagnostic thyroid surgery in case of indeterminate     cytology during fine-needle aspiration biopsy.   "
82917|NCT02200692|"     Allergic transfusion reactions are a common complication of transfusion by blood components     containing plasma. This study aims to investigate passive transfer of Immunoglobin E     antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent     Detergent plasma.   "
82316|NCT02208518|"     Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and     staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis of     solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided fine     needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been     introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses,     being an index of tissue elasticity, which may be related to histopathology features (hard     tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However,     recently publications show different results using elastography. Moreover, a lack of data in     Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the     diameter of the region of interest under analysis in previously studies that by physics could     affect the tissue elasticity.      Based on the hypothesis that elastography could be affected by compression rate of the probe     and the diameter of the region of interest analyzed the present study aimed to evaluate the     quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results     determined by the compression rate of the probe (measured by the curve of compression in the     second generation of elastography) and the diameter of the region of interest in normal     pancreatic tissue.   "
82317|NCT02208505|"     After thyroid surgery, the incidence and severity of coughing is important because it may     cause serious complications, such as bleeding in the surgical field, laryngospasm, and     cardiovascular disturbance. Several studies have shown that the single-dose of     dexmedetomidine is effective for reducing cough and agitation during emergence from general     anesthesia.      To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose     remifentanil infusion during emergence from general anaesthesia could reduce coughing as good     as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and     reduction of side effect of remifentanil using non-inferiority trial.   "
82318|NCT02208492|"     Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as     levetiracetam are reported to have less adverse effect in children but not many studies have     systematically reviewed the subject. This study aims to prospectively evaluate the effect of     levetiracetam on neurocognition, behavioral issues and quality of life, as well as its     seizure control efficacy and other adverse events in pediatric epilepsy patients, in     comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed     for both partial and generalized seizures, despite its well known side effects.      This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from     age 4 to 16 woh will be randomized into two groups, which will be prescribed with     levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and     life evaluations of the patients will be performed at baseline period and after the 52 weeks     of study period.   "
82319|NCT02208479|"     Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical     ventilation and cause respiratory distress.      The investigators' main objective is to determine the incidence of diaphragm dysfunction (     using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic     thickening fraction) in a selected population of cardiac surgery patients during weaning from     mechanical ventilation.      The second endpoints are to determine the associated risk factors to post-operative diaphragm     weakness and the consequence on the patient outcome.   "
82320|NCT02208466|"     In this study investigator's aim to assess the effect of a type of non-invasive brain     stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in     conjunction with fluoxetine on motor recovery after stroke.   "
82321|NCT02208453|"     The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device     implantation in a surgical procedure under local anesthesia using arthroscopic and/or     fluoroscopic visualization of the affected shoulder.   "
82322|NCT02208440|"     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™     device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff     Tear .      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick     DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily     living (ADL) and improvement of range of motion (ROM).   "
82323|NCT02208427|"     Background:      Tuberculosis (TB) remains the most important infectious disease in the world. Keys to     successful control of TB is rapid diagnosis, prompt treatment, as well as effective     preventive therapy for contacts with latent TB infection (LTBI). Current methods for the     diagnosis of LTBI are tuberculin skin test (TST) and interferon-gamma release assay (IGRA).     For preventive therapy, the recommended regimens include daily isoniazid for 9 months and     daily rifampicin for 4 months. By incorporating long-acting rifapentine, a new regimen     combining weekly rifapentine and high-dose isoniazid for a total of 12 doses has been proven     of equal potency and toxicity. However, the treatment completion rate is much higher in     weekly treatment for 3 months than daily treatment for 9 months. It is reasonable that using     rifapentine-based preventive therapy can markedly increase the completion rate. However,     study is lacking, especially in Asia, the high endemic area of TB.      With the effort of all health care workers and public health personnel, the incidence of TB     in Taiwan has gradually declined in recent 10 years. In order to maintain the trend of     decreasing in incidence, preventive therapy for LTBI become more and more important. However,     which is the best preventive regimen for LTBI is still unknown. Therefore, we conduct the     prospective randomized multicenter studies to compare the treatment completion rate of two     regimens in Taiwan. The first regimen is daily isoniazid for 9 months. The second is weekly     rifapentine plus high-dose isoniazid for 3 months.   "
82324|NCT02208414|"     Purpose of this study is to determine whether NAET procedures are effective in the treatment     of crab or shrimp allergy.      Hypothesis: experimental group will show a significant improvement over the control group in     allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp     extract.   "
82374|NCT02207764|"     This research is being done to test whether a complementary intervention, Reiki therapy, can     provide added benefits to the standard patient care. Reiki is method for stress reduction     that uses hand positions over and/or on the body to help people relax.      We are studying the effect of a 15-minute Reiki application compared to an intervention of     nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and     improving patient outcomes. In the future we would like to offer complementary interventions     as an adjunct to our standard care for patients.   "
82325|NCT02208401|"     Different modalities are employed to remove small colonic polyps which potentially harbour a     cancer risk. But, they can all vary in their completeness of removal, safety and the     histological quality and the gold standard technique has yet to be defined. A novel suction     pseudopolyp technique has been described by Patullo et al and in their prospective study, 126     polyps measuring less than 10mm flat or sessile were removed by this method with 100%     complete endoscopic resection and without any immediate or delayed complications. The aim of     the investigators study is to compare this technique with the standard cold snare technique.     Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size     will be eligible and they will be randomised to the polypectomy technique. Patient     demographics and polyp characteristics will be recorded. The primary outcome measured will be     the macroscopic resection rate. The secondary outcome measures are abdominal pain,     tenderness, bleeding and fever.   "
82326|NCT02208388|"     The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography     perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization   "
82327|NCT02208375|"     The goal of this clinical research study is to learn about and compare the highest tolerable     doses and combinations of the drugs Lynparza™ (olaparib), AZD2014, and AZD5363 that can be     given to patients with recurrent endometrial, triple negative breast, ovarian, primary     peritoneal, or fallopian tube cancer. The safety of these drugs and drug combinations will     also be studied.   "
82328|NCT02208362|"     This phase I trial studies the side effects and best dose of genetically modified T-cell     immunotherapy in treating patients with malignant glioma that has come back (recurrent) or     has not responded to therapy (refractory). A T cell is a type of immune cell that can     recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and     a modified gene is placed into them in the laboratory and this may help them recognize and     kill glioma cells. Genetically modified T-cells may also help the body build an immune     response against the tumor cells.      Funding Source - FDA OOPD   "
82329|NCT02208349|"     The goal of this study is to compare the first pass success rate of intubation between video     assisted intubation and traditional direct visualization intubation in the field by Emergency     Medical Service (EMS) professionals   "
82330|NCT02208336|"     This research trial studies electronic medical record review in monitoring the effects of     adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors     receiving temozolomide and radiation therapy. Myelosuppression is a condition in which bone     marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and     platelets and is a side effect of some cancer treatments. Morbidity is a term that refers to     having a symptom of disease or medical problems caused by a treatment. Monitoring patients'     electronic medical records to compare side effects, such as myelosuppression and morbidity,     with treatment adherence may be a way to enhance patient care by organizing data for medical     staff.   "
82331|NCT02208323|"     This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to     fit older children, will create a safe form of respiratory support that may help to decrease     respiratory distress and thus mortality from pneumonia.   "
82332|NCT02208310|"     Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is     a major source of vitamin D. There is some research to suggest that patient's with higher     vitamin D levels are less likely to undergo surgeries and have better control of their     disease. We intend to study the effects of high dose vitamin D supplementation in patients     with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses     will have less hospitalizations, surgeries, steroid use.   "
82333|NCT02208297|"     The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate     (LE) ophthalmic gel, 0.38% (BID)   "
82334|NCT02208284|"     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single     oral doses of PF-06427878 in healthy adult subjects.   "
82335|NCT02208271|"     The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for     adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement.      A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal     revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant,     control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial     fluid will be obtained from all hips and used for biomarker testing. Additionally,     intraoperative assessment of tissue necrosis will be assessed.   "
82336|NCT02208258|"     The purpose of this study is to evaluate the safety, efficacy, and functionality of the     Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal     incontinence.   "
82337|NCT02208245|"     The brachial plexus block is an anesthetic technique often used for surgical procedures of     the upper limb. To get the brachial plexus block, several routes can be used, including the     axillary and infraclavicular approach.      Few studies have compared these techniques, considering the time to perform the block, the     onset time and success rate, with conflicting results. Furthermore, there is little     information in the literature comparing the length of postoperative analgesia provided by     these techniques.      Therefore, the investigators designed this study in order to elucidate the differences     between these two techniques to assist the anesthesiologist to choose the best of them in     clinical practice.   "
82338|NCT02208232|"     The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125     AS IOL.      At the end of surgery the orientation of the IOL is documented with a short video clip via     the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6     months after surgery. Rotational stability of the IOL is assessed using retroillumination     images with a method to avoid bias from cyclorotation or head tilt.   "
82410|NCT02207296|"     The purpose of this study is to determine whether an operative hemodynamic optimization using     the plethysmographic variability index during orthopedic surgery could decrease the length of     hospital stay and the postoperative morbidity.   "
82724|NCT02203214|"     The purpose of this study is to evaluate the safety and effectiveness of the Ligamys     technique for the treatment of acute ruptures of the anterior cruciate ligament in a     multicenter routine clinical setting. To conduct a long-term follow-up of the case series as     a post-market product surveillance endeavor.   "
82339|NCT02208219|"     Motor deficits are common after stroke, being one of the major causes of disability in this     population. Because of the impact that motor impairments have in the life of patients and the     associated financial costs, it is a health care priority to develop effective and efficient     treatments to restore motor deficits. Music-supported therapy (MST) has been recently     developed to enhance the use of the affected extremity after stroke.      In the present project, a new multidisciplinary approach (neurology, neuropsychology, music     and cognitive neurosciences) will be undertaken in order to investigate the effectiveness of     MST as a neurorehabilitation technique to restore the motor function in stroke patients. In     addition, the complex pattern of reorganization of the sensorimotor system will be studied in     order to provide information about the physiological mechanisms underlying the     neurorehabilitation process.      A randomized controlled trial is proposed to compare for first time the effectiveness of MST     (at the hospital and at home) compared to conventional treatment in subacute stroke patients     suffering from motor deficits. Our hypothesis is that patients will experience a large     improvement in the functional use of the affected arm due to the implementation of the MST     program when compared to conventional treatment. We also expect to observe improvements in     cognitive functions, mood and quality of life. Besides, we hypothesize that these     amelioration in motor and cognitive domains will be accompanied by neuroplastic changes in     the sensorimotor cortex and corticospinal tract.   "
82340|NCT02208206|"     The purpose of this study is to analyze associations between symptoms and specific markers in     the blood in patients suffering from neuropathic pain linked to diseases of different origin.     Such markers could be utilized in the future for precise diagnosis of neuropathic pain and     might lead to targeted pain treatment.   "
82341|NCT02208193|"     Gardens and art represent public spaces and support venues of interactions and emotions,     seeking not only a variety of conversational themes but also various cognitive skills such as     mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden, jointly     associated and made available to patients suffering from Alzheimer's disease, need to be     evaluated.      MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on cognitive     and emotional processes by means of interview analyses in Alzheimer patients and control     subjects based on the  art, memory and life  garden.      SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer     patients:        -  create assessment methods of:        -  the therapeutic efficacy of the design of the  art, memory and life  garden,        -  the perception of an artistic dimension in the living environment of those with          Alzheimer's disease,        -  establish:        -  workshop applications using art and the garden for therapeutic purposes,        -  general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative data          of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007,          2010, 2011) for the analysis of interactive behaviors and the assessment of parameters          including esthetic appraisals, well-being, mnemonic and emotional processes (frequency          and nature of these processes) as well as spatio-temporal orientation.      SECONDARY ENDPOINTS        -  Scores obtained in standard neuropsychological tests, in particular to assess          spatio-temporal orientation (Folstein MMSE),        -  Scores obtained with the  MemoArtZ  tool (MAZ) to evaluate the memorization of          artistic elements of the garden,        -  Scores from the  General Esthetic Preference  (GEP) tool to evaluate the consistency          of general esthetic appreciations,        -  Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,        -  Score obtained with the specific assessment of emotional events scale (AES) for all          subjects.      RESEARCH METHODOLOGY      Open, monocentric, controlled (group of healthy control subjects) study.      Population: 2 groups:      Group A Alzheimer group: patients with mild to severe stages of Alzheimer's disease:     subgroup A1 Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul     Spillmann, CPS) (CHU de Nancy, France); subgroup A2 Alzheimer group monitored at the     Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)     (CHU de Nancy, France) Group B healthy control group: healthy volunteers      Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care     management, notably: i) by determining the design, conception and layout of the gardens     destined to these patients, ii) by developing the introduction of an artistic dimension to     the design of such healing gardens and in their living environment, iii) by establishing     workshop application perspectives using the contemplation of works of art and the garden for     therapeutic purposes.   "
82342|NCT02208180|"     The investigators are conducting a two group intervention to study to the effect of     individualized heart disease genomic risk results on motivation towards diet and physical     activity behaviors to reduce heart disease risk. The intervention includes provided     participants with genomic and lifestyle risk estimates. Investigators will follow     participants for 3 months to determine if motivation towards and engagement in diet and     physical activity behaviors change.   "
82343|NCT02208167|"     This is a phase 1, single-site study is to evaluate the safety and immunologic and virologic     efficacy of ex vivo expanded HIV-1 multi-antigen specific T-cell (HXTC) therapy in     HIV-infected individuals with viral suppression on antiretroviral therapy (ART).   "
82344|NCT02208154|"     Previous research has shown that applying certain treatments can reduce both the number of     infections and the presence of resistant bacteria in the intensive care (ICU) and its     patients. These treatments have been used as standard care throughout the world for many     years, but they have not been compared to each other yet. The investigators aim to evaluate     the effect of 3 different treatments on the occurrence of resistant bacteria and bacterial     infections in the ICU and to establish which treatment is the best.      All adult patients undergoing mechanical ventilation are eligible for this study and will     receive treatment according to the study scheme. Twice weekly, sputum and rectal samples will     be obtained to measure the effects.      All ICU-patients will receive standard treatment, consisting of daily body washing with an     antiseptic (chlorhexidine 2%), oral care and a hand-hygiene program for health care workers     as endorsed by the WHO. According to 4 different study periods, each participant will receive     one of the following extra treatments depending on his or her admission date:        -  Standard treatment only (this is the control group)        -  Chlorhexidine 1% oral gel, this is an antiseptic.        -  Antibiotic mouth paste containing 3 different antibiotics (selective oropharyngeal          decontamination, SOD).        -  Antibiotic mouth paste and suspension for the stomach and intestines containing 3          different antibiotics (selective digestive decontamination, SDD).      All treatments will be given 4 times daily with the purpose of killing harmful bacteria in     the mouth (CHX, SOD,SDD) and digestive tract (SDD).      During the study the investigators will examine the effect of these treatments on:        -  the occurrence of blood stream infections with certain bacteria        -  cross-transmission of certain bacteria between patients        -  presence of these bacteria in the respiratory tract of the patients        -  patient survival      Benefits: Previous research has shown that these interventions can reduce infections in     intensive care patients.      Risks: The interventions performed (both cultures and treatment) are considered safe and are     already given as standard care in many ICUs throughout the world. There is a slight risk that     bacteria become resistant to antibiotics: this will be monitored closely during the trial.   "
82345|NCT02208141|"     In this study the investigators hypothesize that pathological alterations in adipose tissue     biology already occur during the development and progression of obesity in children and     adolescents. The investigators aim to identify and characterize mechanisms and molecular     targets that affect the development of adipose tissue and ensuing obesity in childhood and     adolescence.   "
82391|NCT02207543|"     The proposed work is part of a multidisciplinary approach to continuity of care in the     particular context of the palliative phase of cancer. In conducting this study, we would like     to characterize, at the regional level, satisfaction with the care of patients and their     families in their care home situations palliative cancer. This evaluation will be based on     questionnaires adapted versions in French language satisfaction questionnaires recently     validated for patients in palliative situation and supported home care.      It will also identify the challenges faced by both patients, caregivers attending physicians.      The evaluation of these elements is a prerequisite to propose ways of improving at a hospital     palliative care for output relay and anticipate the coordination of care for optimal care of     the patient at home, to meet the expectations of different stakeholders, or even prevent     certain readmissions avoidable.   "
82392|NCT02207530|"     Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR   "
82346|NCT02208128|"     Aim of the scientific analysis is to find biological factors (biomarkers) allowing a     prediction of disease progression and a better choice of therapy. After diagnosis the kidney     and the tumor will be removed by standard surgery followed by drug therapy. Within surgery     remaining tumor tissue will be used for the scientific analysis. In case of disease     progression during the drug treatment the drug therapy will be changed. Before therapy change     a small tissue sample will be collected for molecular diagnostics. This will be done by     puncture through the skin under local anesthesia. Blood samples taken before surgery and at     the time of first and second disease progression will also be used for molecular-biological     analysis. As there is no clear recommendation for drug therapy after disease progression this     study should serve to determine an individual therapy on the basis of the molecular profile     and the molecular changes. As the tumor disease changes and developes resistance to drugs,     analysis at the time of disease progression shall identify biological factors which will     predict a likelihood response to a specific drugs.      This shall allow to give the patient an individual therapy.   "
82347|NCT02208115|"     The investigators hypothesise that manipulating the glycaemic index of the meal after     exercise will influence the acute appetite responses of Type 1 diabetes individuals   "
82348|NCT02208102|"     The purpose of this study is to assess if pre-ablation levels of inflammatory biomarkers     serve as independent predictors of procedure outcome To evaluate the inflammatory activation     following catheter ablation by measuring serum-biomarker levels 24-hours after the procedure     and examine the predictive role in procedure success To study the association of certain     biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)   "
82349|NCT02208089|"     Young patients with keratoconus face two problems: disease progression and corneal shape     irregularity leading to poor vision even in spectacles.      Corneal collagen cross-linking (CXL) is a new treatment designed to halt disease progression     in keratoconus. The aim is to stiffen the cornea thereby preventing further shape     deterioration.      Topography or wavefront guided transepithelial photorefractive keratectomy (transPRK) uses     the excimer laser (the laser used to correct sight in 'laser eye surgery') to reduce corneal     shape irregularity in early stage keratoconus, reducing dependence on contact lenses.      In transPRK, the corneal skin layer is removed in a well controlled, no touch procedure,     preparing the cornea for CXL. Performing both treatments simultaneously (combining both     procedures in one operation) may offer several advantages over performing CXL first then     waiting for corneal shape to stabilise before performing transPRK. In particular, visual     rehabilitation may be faster. This study aims to evaluate visual recovery after simultaneous     CXL and transPRK in progressive early stage keratoconus. Visual recovery in these patients     will be compared with results for a similar group of patients with early stage keratoconus     who have already been treated with CXL alone.   "
82350|NCT02208076|"     This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via     easypod™.   "
82351|NCT02208063|"     This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus     standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin     (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S.     aureus) bacteremia and SA right-sided infective endocarditis (RIE).   "
82352|NCT02208050|"     The purpose of this study is to examine the effect of treatment with fampridine in patients     with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb     dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in     the range 4.0-7.0 on upper limb function assessed by the nine-hole peg test (9-HPT) and the     Jebson Taylor Hand Function Test (JTT).      Fampridine has been shown to be effective in improving motor function, specifically walking     ability in prior studies in this patient population and is currently licensed for this use in     Europe and the United States. Upper limb dysfunction is common in SPMS and PPMS and often     underestimated. Fampridine effects action potential conduction in demyelinated nerve fibres     and we would hypothesise that the improvement previously reported in walking ability would be     similar to that on upper limb dysfunction. Our study aims to address this question using both     independent and patient reported outcomes in the context of a randomised placebo controlled     crossover trial.   "
82353|NCT02208037|"     Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after     allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if     any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free     survival at one year after transplant compared to the current standard prophylaxis regimen.   "
82354|NCT02208024|"     The purpose of this study is to test the safety of focused radiation (Stereotactic Body     Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.   "
82355|NCT02208011|"     Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as     compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart     review after delivery.      Inclusion Criteria:        -  English speaking        -  pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes      Exclusion Criteria:        -  Known placental previa        -  Active vaginal bleeding   "
82383|NCT02207647|"     Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a     potentially infectious nature are among those of greatest concern. Routine clinical and     laboratory evaluation of such patients involves screening for known infectious disease     agents, selection of which is nonstandardized. Progress in diagnostic technologies,     especially molecular techniques based on genetic characteristics of potential pathogens, has     greatly expanded the investigators capacity to evaluate specimens from patients for a much     wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of     Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative     agents for the approximately 50% of all such presentations which go un-diagnosed. The     investigators propose a study involving a collaboration between the EMERGEncy ID NET, a     network of 10 geographically diverse university-affiliated urban emergency departments     (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and     Prevention (CDC), to use these new technologies to address this issue.   "
82356|NCT02207998|"     Osteoarthritis (OA) is a chronic arthropathy characterised by disruption and possible loss of     joint cartilage along with other joint changes. OA symptoms include progressively developing     joint pain provoked or elicited by activity, joint stiffness that lasts for less than 30     minutes on waking and after activity, and occasional joint swelling. It is a common specific     mechanical cause of chronic low back pain. Conventional treatment for OA includes     physiotherapy treatment and drugs such as paracetamol, non-steroidal anti-Inflammatory drugs     (NSAIDs), intra-articular injection of corticosteroids and surgery, however these may have     possible side effects. Arnica montana, Bryonia alba, Rhus toxicodendron, Causticum, Kalmia     latifolia and Calcarea fluoride are homoeopathic remedies indicated and used in the treatment     of OA, however, there is no evidence of studies conducted on a complex made up of these     remedies.      The aim of the study is to investigate the efficacy of the homoeopathic complex (Arnica     montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH     and Calcarea fluoride 6CH) and physiotherapy in the treatment of chronic low back pain due to     osteoarthritis, using the Oswestry Low Back Pain Disability Questionnaire, range of motion     (ROM) measurement using the attraction tape and the visual analogue pain scale (VAS) .   "
82357|NCT02207985|"     Aim:      To study the antitumour effect of reduced intensity conditioning (RIC) with allogeneic stem     cell transplantation (HSCT) in patients with pancreatic adenocarcinoma after radical     resection of the tumour and adjuvant treatment with standard chemotherapy.      Importance:      If investigators can accomplish an anti-tumour effect using RIC with HSCT as adjuvant     treatment in patients with pancreatic adenocarcinoma, it might increase the survival or even     cure patients in this group with very poor prognosis.      Primary scientific question:      Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using     adjuvant treatment with HSCT?      Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using     adjuvant treatment with HSCT?   "
82358|NCT02207972|"     The investigators believe that ultrasound guided CSE technique will accurately place the     epidural needle in the midline position compared to epidural needle placement via palpation     of anatomical landmarks. This will result in positive CSF in the spinal needle, correct     placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.   "
82359|NCT02207959|"     The overall objective of this pilot study is to determine whether multispectral imaging     increases the diagnostic accuracy of the current standard of high-definition white-light     endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part of     an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic platform     that can be used to survey a large surface area and, potentially, serve as a red flag for     microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical and     endoscopic specimens, the investigators have identified the optical settings and illumination     wavelengths that are complementary to white-light imaging and enhance superficial mucosal and     vascular changes associated with neoplasia. Based on this initial testing, vital-dye enhanced     fluorescence imaging (VFI) and imaging with High Resolution Microendoscope (HRME) have been     identified as modalities that may be complementary to white-light imaging. The goal of this     pilot study is to preliminarily determine the accuracy of these modalities during the     endoscopic surveillance and detection of gastric neoplasia.   "
82360|NCT02207946|"     The objective of this study is to assess the efficacy and safety of a single,     kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in     moderate to marked essential tremor of the upper limb.   "
82361|NCT02207933|"     To investigate the effect of anteroposterior weight shifting training with visual biofeedback     on step length asymmetry. Reduced speed and asymmetry of stepping is a specific     characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step     length of the unaffected limb compared to the affected limb. Causes of this phenomenon are     difficulty in weight bearing at the affected limb, weak propulsive force of the affected     limb, and decreased strength of hip extensors. To correct these factors. we have developed an     anteroposterior weight shifting training system with visual feedback and studied its effects.   "
82362|NCT02207920|"     This study will evaluate the safety, tolerability, and immune response to different     combinations of two experimental HIV vaccines—the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E     vaccine—in healthy adults who are not infected with HIV.   "
82363|NCT02207907|"     The primary objectives of this study will be to compare the Gingival Bleeding and Gingival     Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice     compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be     conducted at Silverstone Research Group. Participants will be recruited from their database     and by use of an external recruitment agency.   "
82364|NCT02207894|"     This research program is initiated to evaluate and document data on the success of ITI in 300     haemophilia A patients with newly developed or already existing FVIII-inhibitors (also     patients who might potentially have failed in earlier ITIs), which will be treated with ITI -     preferably high-dose based on individualized product selection, in order to improve     management of this potentially devastating complication of haemophilia treatment.      In order to investigate the role of in vitro tests on individual ITI success rate in patients     undergoing ITI, the inhibitor plasma samples can be assayed against different FVIII     concentrates using the following in vitro tests: Batch selection, Thrombin generation assay     (TGA), Thrombin Generation Test (TGT) to monitor FVIII efficacy, Epitope mapping,IgG     Subclasses specific for FVIII, Immunogenotyping.   "
82384|NCT02207634|"     This study evaluates change over time in neurocognitive testing in subjects receiving statin     therapy in combination with evolocumab (AMG 145), compared with subjects receiving statin     therapy in combination with placebo.   "
82385|NCT02207621|"     Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic     Solution compared to Timolol Maleate Ophthalmic Solution   "
82386|NCT02207608|"     The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in     reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial     cell carcinoma.   "
82387|NCT02207595|"     The primary objective of this study is to investigate the safety and tolerability of UCB5857.   "
82388|NCT02207582|"     Transcranial random noise stimulation is used to stimulate the prefrontal cortices in     patients with depression. It's a placebo-controlled two-arm study.   "
82365|NCT02207881|"     Recurrent herpes labialis are usually a minor malady of limited duration, although they are     often painful and are uniformly discomforting for patients. Oral antivirals represent an     advance in the treatment of recurrent herpes labialis, but the clinical implications are     modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the     duration of lesion episodes and pain by approximately one day. In recurrent HSV infections     including herpes labialis, many instances of viral re-activation occur without symptoms, and     can only be identified by detection of virus on the lips of infected individuals. In these     cases, the virus is cleared from the local site without the development of a classical     ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly     stops viral replication in the skin and also causes the development of the herpes lesion     prodrome and a considerable part of the symptoms associated with a classical ulcerative     herpes lesion. One could therefore predict that treatment with an antiviral drug alone would     help the immune system in shortening the virus replication, but may not substantially reduce     the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of     using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related     symptoms associated with the infection has been well established. We have found that a     topical formulation of VDO is useful for alleviating pain and inflammation associated with     infection caused by herpes virus.   "
82366|NCT02207868|"     The aim of the study is to document the left and right ventricular function in patients with     sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results     of this study should help to generate hypothesis for further future studies.      The primary hypothesis is that the increased use of modern image guided methods could provide     essential aspects for the follow up.   "
82367|NCT02207855|"     This a study to retrospectively review our experience with the use of chloroprocaine for     postoperative epidural infusions in neonates and infants. Pain scores and the need for     intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of     the technique.   "
82368|NCT02207842|"     One of the most common side effects of a surgical procedure is infection. In order to lower     the number of infections that occur after surgery, it is important for physicians to know how     medications used during surgery affect the way the body fights infection. Often, when     anesthesiologists are helping people go to sleep before surgery they give people medications     known as volatile anesthetics. Volatile anesthetics are medications that can change from a     liquid or solid to a gas very easily. Some studies suggest that these types of medications     may change the way white blood cells work in the body. Changing the way white blood cells     work could possibly increase the person's risk of infection after their surgery or weaken     their body's ability to fight infections. The goal of this research study is to learn about     how volatile anesthesia medications change the way white blood cells work in people having     anesthesia for cardiac procedures. To do this, investigators will examine the function of     while blood cells in the laboratory based setting.   "
82369|NCT02207829|"     This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate     the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)]     when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD)     administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in     Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the     run-in period, subjects who meet the randomization criteria will be randomized to receive     UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via     HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo     administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an     outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in     period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28     (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in     Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day     168 (Visit 10). The total duration of subject participation in the study will be     approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic     visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects     will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be     obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits     3 to 7.      HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.   "
82370|NCT02207816|"     The purpose of this study is to conduct long-term surveillance for efficacy, safety and     immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria     vaccine in infants and children in Africa following a primary vaccination series     (NCT00866619). No new subjects will be enrolled in this extension study.   "
82371|NCT02207803|"     Traumatic brain injury (TBI) patients in Latin America experience high levels of disability     and extremely poor functional outcomes, and their informal caregivers play a key role in     their rehabilitation and care. To improve TBI rehabilitation through stronger informal     caregiving, the proposed study will develop and evaluate an evidence--based and culturally     sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin     America during the patient's transition from hospital to home. This study will generate     findings that can provide empirically supported guidance to clinicians regarding the     provision of culturally tailored rehabilitation services for TBI caregivers in Latin America     and in the U.S.   "
82372|NCT02207790|"     This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for     E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK     characteristics, the proposed study includes a cohort of white subjects treated for     comparison with the cohort of Japanese subjects treated at the same dose. This comparison     serves as a key PK bridge in assessing ethnic factors that may contribute to differences in     plasma concentrations. Pharmacokinetic assessments in the proposed study will include     confirmation of dose proportionality in Japanese subjects. This study will also evaluate     safety and tolerability in Japanese subjects.   "
82389|NCT02207569|"     The study objectives are to assess the safety and efficacy of the CoreValve Evolut R     transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic     aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.   "
82375|NCT02207751|"     The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and     the best way to collect data regarding their function in England, Wales and Northern Ireland.      Phase 1: We will carry out a detailed examination of existing returned pilot data with     emphasis on data fields with poor data completeness and perform root cause analysis, and     assess deficiencies in data field definition to identify improvements to be implemented. We     will construct and disseminate electronic survey material to all study centres with targeted     visits by the Principle Investigator undertaken. These visits will facilitate insight into     local organization of data collection including interaction with designated individuals     responsible for data returns. PD training days will be organized with emphasis on clinical     practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics     will be linked to existing acquired PD patient information to ensure the accuracy of     collected data. An online data acquisition system will be developed to allow direct data     entry from centres.      Phase 2: On-going and sustained data acquisition performed on a prospective basis.      Phase 3: Primary data analysis including clinical practice variation in England, Wales and     Northern Ireland to identify site specific PD catheter functionality variation. Additionally,     patient and site specific characteristics that predict clinical outcomes in PD will be     identified and characterised.      Phase 4: Clinical guidelines will be developed.   "
82376|NCT02207738|"     Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar     radiofrequency treatment for acne scar.   "
82377|NCT02207725|"     The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the     anticoagulation effect of Apixaban.   "
82378|NCT02207712|"     In this study, the investigators aim to use light masks (Noctura 400) to test the hypothesis     that preventing the dark adaptation and associated hypoxia of the rods in the eye could in     turn prevent or halt the progression of centre-involving Diabetic Macular Oedema (DMO). DMO     is a devastating disease that is the most common cause of registerable blindness in the     working age-group in the United Kingdom (UK)      This is a multi-centred randomised controlled trial involving 240 patients. Post     randomization, participants in the intervention arm will wear the Noctura 400 Light Mask at     night for 48 weeks in conjunction with their routine, prescribed treatment of intravitreal     (eye) ranibizumab. Those in the standard arm will receive their routine, prescribed     ranibizumab treatment only.      The primary objective is to determine whether utilizing the Noctura 400 Light Mask at night     reduces the number of intravitreal injections of ranibizumab required by patients undergoing     such a course for the treatment of DMO.   "
82379|NCT02207699|"     The primary objective of this study is to determine the effects of benzonatate (200 mg and     800 mg) on the QT interval following single dose oral administration at each time point     post-dose.   "
82380|NCT02207686|"     The investigators aim to analyze tumors from vHL patients who have different courses of     disease and different types of VHL gene alterations to characterize which types of genetic     alterations the tumors contain and how these alterations affect the tumor cells' behavior on     a molecular level. The investigators will then compare these observations to vHL disease     outcome in patients and families.      It is already known that most vHL tumors develop when both copies of the VHL gene in a cell     are inactivated. The first copy is inactivated in all the person's cells from birth (first     hit), leaving just one functional copy. A tumor can develop from cells where the second copy     is also inactivated (second hit). So far, only the molecular consequences of the first hit     have been investigated. It is our hypothesis that both the first and second hits in     combination have consequences for tumor development and clinical outcome. The investigators     will include tumors from patients with different disease courses and different types of     first hits and analyse the tumors' DNA in order to find correlations between the first and     second hits and patients' and families' medical histories. The investigators hereby hope to     give new insights into how vHL tumors grow and which genetic factors influence tumor     development. These results will contribute to the current knowledge of vHL and help us get     one step closer to be able to predict an individual's tumor risks and need for surveillance.   "
82381|NCT02207673|"     Epilepsy occurs in 0.5-0.7% of the population, of which 25% are children. 30% Of patients     with focal epilepsy do not respond well to medication and half of them are eligible for     epilepsy surgery. In recent years, the importance of early epilepsy surgery has been     stressed, as successful surgery may lead seizure and medication freedom and improved social     and cognitive development, especially in children. The current success rate of epilepsy     surgery is around 65%; During surgery intracranial electrocorticography (acute ECoG, aECoG)     is recorded in some medical centers. The presence of epileptiform brian activity, spikes,     identified by clinical neurophysiologists, is used to guide the neurosurgeon in the extent of     the brain tissue that needs to be resected. Spikes are considered markers of the presence of     epilepsy. High Frequency Oscillations (HFOs, >80-500Hz) in the ECoG have recently been     identified as a new biomarker for epileptogenic tissue. Retrospective research shows that     their local presence strongly relates to the seizure onset, and removal of tissue with HFOs     could predict a better surgical outcome. The area showing HFOs usually overlaps with, but is     smaller than the area with spikes, and HFOs do not tend to propagate to distant sites as     spikes do. The identification of HFOs is more objective than of spikes and automatic     detection software exists.      A pilot study is performed to test the hypothesis : The intra-operative use of HFOs to     delineate the epileptogenic cortex does not yield significantly worse outcome in seizure     freedom than the current method based on spikes.      Study design is a single blinded multi-center randomized controlled trial. In two Dutch     centers, the VU medical center ( Amsterdam) and University Medical Center Utrecht.      The study population (sample size 78) consists of patients of all ages with refractory     epilepsy undergoing epilepsy surgery with aECoG to guide the extent of the resection.      Eligible patients are randomised, after informed consent, into group 1 (HFOs) in whom a     resection guided by HFOs in the aECoG (new), or into group 2 (spikes) in whom a resection is     guided by epileptiform spikes in the aECoG (current standard). Ictiform spike patterns will     always be resected.      Main study endpoint is outcome after epilepsy surgery after 1 year of follow-up dichotomized     in total seizure freedom (Engel Ia&b) vs. seizure recurrence (Engel Ic-IV).   "
82382|NCT02207660|"     Objectives: To evaluate the effectiveness and toxicity of the combination of infusional     cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly     every 21 days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.      Methods: The medical records of all patients with stage IVB, recurrent or metastatic cervical     cancer who were treated with P-HDFL regimen between January 2005 and December 2009 at     National Taiwan University Hospital were reviewed.      Expected results: Investigators will identify the effectiveness and toxicity of the     combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus     leucovorin (P-HDFL) repeatedly every 21days for the treatment of stage IVB, recurrent or     metastatic carcinoma of cervix.   "
82406|NCT02207348|"     This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence     between single-dose liraglutide administered subcutaneously with two different pen-injectors.   "
82393|NCT02207517|"     CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9     to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to     see if office-based therapy for convergence insufficiency (CI) improves reading ability and     attention. CI is an eye-teaming problem where the eyes would like to drift outward when     reading or doing close work. When eyes drift out, double vision can happen. To prevent double     vision one must use extra effort to keep the eyes from going out. This extra effort can cause     symptoms that can interfere with reading and working comfortably at near. These symptoms     often include eyestrain, blurred vision, headaches, double vision, and loss of place when     reading or performing tasks at near. In a prior study we found that therapy improves these     symptoms. In this study we are looking at whether the therapy improves reading and attention   "
82394|NCT02207504|"     This research study is comparing the combination of drugs Crizotinib and Enzalutamide as a     possible treatment for metastatic castration-resistant prostate cancer (mCRPC).   "
82395|NCT02207491|"     To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324     Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic     Solution, 0.5%   "
82396|NCT02207478|"     The purpose of this study is to evaluate the efficacy and safety of electromagnetic     navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary     lesions (PPLs) .   "
82397|NCT02207465|"     The investigators hypothesize that intensification of local therapy will lead to improvements     in local control and survival in patients with unresectable and borderline resectable     pancreatic cancer. The investigators propose to do this by combining nab-paclitaxel     concurrently with dose-escalated radiation therapy. In the first part of this phase I study     (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation dose is held     constant at a standardly accepted level. The use of this novel chemoradiotherapy regimen will     take advantage of nab-paclitaxels specific anti-tumor and anti-stromal properties, which may     enhance the efficacy of radiation therapy, and thereby improve local control. After the MTD     of nab-paclitaxel had been determined, in the second part of this study (sub-trial 2), the     investigators will administer nab-paclitaxel at the determined MTD concurrently with     escalated doses of radiation. The investigators will utilize a combination of protons and     IMRT to safely deliver high doses of radiation while maximally sparing surrounding normal     tissue. Patients will also preferentially have 2-3 fiducial markers placed in or around the     tumor for daily localization and will be treated at breath hold in order to prevent tumor     movement with normal respiration. Such a technique will help minimize target volumes and     thereby avoid critical normal structures. The investigators will use gemcitabine and     nab-paclitaxel before and after chemoradiotherapy given its promising results in metastatic     pancreatic cancer patients. Correlative tissue and serum biomarkers are an important, but     optional, part of this study.   "
82398|NCT02207452|"     This protocol describes the investigation of the use of hyperpolarised helium magnetic     resonance imaging (MRI) in reflecting the regional differences in lung function of moderate     to severe Chronic Obstructive Pulmonary Disease (COPD) patients.      Since finalisation of the original protocol, new medications for COPD have received Market     Authorisation Approvals. Protocol Amendment 02 has been prepared to include these medications     in the protocol eligibility criteria and restrictions for the study.   "
82399|NCT02207439|"     This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease     inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible     patients will receive a lead-in period of Nelfinavir (1250 mg po bid) for 7-14 days prior     to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based     chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).   "
82400|NCT02207426|"     This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device     with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of     tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.   "
82401|NCT02207413|"     The purpose of this trial is to demonstrate the acceptable safety profile and the     immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational     process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the     current licensed process (FLU D-QIV Licensed Process [LP]).   "
82402|NCT02207400|"     This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily     use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate     toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc.     Participants will be recruited from their database and by use of an external recruitment     agency   "
82403|NCT02207387|"     This study will investigate the effects of a contingency-based musical walking intervention     program called Ambulosono on neural mechanisms in the brain. The investigators will     investigate the long-term impact of Ambulosono on brain plasticity with functional MRI     technique. Participants will undergo 3 months of Ambulosono training and their pre-training     and post-training fMRI brain scans will be compared to understand the neural networks and     brain mechanisms following this intervention. The investigators hypothesized that Ambulosono     may induce functional compensatory reorganization of neural networks in the brain. This     project will allow us to address the important potential confound of placebo influence and to     aid in optimizing this intervention program. Additionally, the investigators are hoping to     investigate the synergistic effects of rasagiline and exercise; the investigators' hypothesis     is that there will be a positive synergistic effect, and that exercise will augment the     effectiveness of rasagiline in treating Parkinson's symptoms.   "
82404|NCT02207374|"     This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy     of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic     drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on     diet/exercise therapy or OAD monotherapy.      All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD     monotherapy in addition to diet and exercise therapy) during the trial.   "
82405|NCT02207361|"     Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National     Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is     also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.   "
82411|NCT02207283|"     This study is intended to build on recent findings from our laboratory showing that a single     dose of tadalafil (also known as Cialis) restored normal blood flow regulation in men with     Becker muscular dystrophy. The investigators now wish to extend these findings by showing     that the same dose of tadalafil will also prevent muscle injury and fatigue. Patients will     take a single dose of tadalafil prior to exercising. Then doctors will measure whether the     patients muscles receive more blood flow and are better protected during exercise.   "
82412|NCT02207270|"     The purpose of this study is to determine whether the total costs of care associated with     uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through     30-day follow up are lower among patients who are randomly assigned to same day discharge     (SDD) or overnight hospital stay (ON).   "
82413|NCT02207257|"     This study will evaluate the establishment of anticoagulation (re-anticoagulation) of     subjects with edoxaban following reversal by PER977 and will identify a dose regimen of     PER977 that reverses the effects of edoxaban for up to 21 hours.   "
82414|NCT02207244|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab     (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis     (scaly skin rash).   "
82415|NCT02207231|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab     (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.   "
82416|NCT02207218|"     This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy     of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the     setting of routine clinical practice.   "
82417|NCT02207205|"     1. Determine if there is any difference between the whole blood clotting time results          obtained from blood drawn from indwelling catheters and direct venipuncture        2. Determine the intra-subject variability in both procedures   "
82418|NCT02207192|"     Postural changes are known to affect normal lung volumes. A reduction in sitting to supine     functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine     position. However, postural changes in lung volumes in the obese require further exploration.     We aimed to longitudinally address the effects of weight loss on postural changes in lung     volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in     FRC would be absent in morbid obesity and recovered upon weight loss.   "
82419|NCT02207179|"     This study will evaluate LumaScan, an innovative polarization microscope for real time,     intraoperative imaging and evaluation of the surface of excised tissue excised during Breast     Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators     hypothesis is that LumaScan will be comparable for cancer detection to conventional     histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative     images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision     surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and     loss of confidence in the tissue conservation surgery procedure.   "
82420|NCT02207166|"     Medical devices are designed and manufactured by subjective design process that was only     based on engineers' direct concepts to essential principles sets for the device. A home user     may not easily use or operate the piece of medical device through the interfacing components     as the designer's expected such as the meaning when pushing a button or switching a knob,     even the required procedure needed when a certain display shown to fulfill some knowledge     dependent judgment. In addition, the incompatible interfacing designed communication between     a user and the device may cause possible errors that may trigger further negative     consequences during the use of the device to a innocent home user.      The aim of this research is to closely understand the consequent results of human factor     engineering or usability engineering practices of various types or models of marketed     home-use blood pressure monitors (BPM) in real use.   "
82421|NCT02207153|"     Patients undergoing chronic dialysis are at a substantially increased risk of cardiac death.     The reasons for this excess cardiovascular mortality are only partly understood. Classical     complicated artherosclerotic disease does not appear to be the primary cause of cardiac death     in chronic dialysis patients. In fact, the predictive potential of classic cardiovascular     risk factors such as hypertension, obesity and hyperlipidemia appears to be reduced in     dialysis. In contrast, in a series of pilot studies we found cardiac biomarkers to adequately     reflect dialysis induced myocardial stunning, progressive cardiovascular disease, and the     risk of death.      To extend and corroborate these results, we are planning a large, prospective, observational     study enrolling unselected hemo- and peritoneal dialysis patients. The proposed study, its     power calculation and hypotheses are based on our pilot studies   "
82422|NCT02207140|"     The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks.     Following randomization, healthy elderly are randomized into two groups receiving probiotics     or placebo. Fecal samples are collected before and after the study. The samples are     investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as     well changes in the fecal metabolome. The effects of the produced metabolites on     mitochondrial activity will moreover be investigated using selected intestinal cell lines.   "
82434|NCT02206984|"     RATIONALE: Currently, adjuvant endocrine therapy often follows a one-size-fits- all     approach, with most premenopausal women receiving tamoxifen, and most postmenopausal     receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive     lobular carcinoma are treated no differently than patients with invasive ductal carcinoma     based on the void of information specific to patients with this tumor type. Identification of     a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC     patients would have dramatic implications for the future management of this breast cancer     subtype.      PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in     reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in     expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as     a surrogate for outcome of ILC patients on endocrine therapy.      Primary Objective:      To determine the change from baseline to post-treatment Ki67 values in ER-positive,     HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or     further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine     treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given     orally daily), or tamoxifen (20mg given orally daily).   "
82423|NCT02207127|"     There is a fundamental gap in the investigators ability to design effective surgical     treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate     non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful     outcome ranging from 5% to 65% for individual or combination procedures. To predict - and     thereby to improve - outcomes, the investigators must determine what predicts surgical     success. This project will compare findings from two evaluations: drug-induced sleep     endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated     important benefits, but it has important limitations. Upper airway MRI is the most complete     evaluation performed during wakefulness, making it conducive to broad application and less     expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The     investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe     OSA. In addition to history, physical examination, and polysomnogram (sleep study), all     subjects will undergo DISE and MRI to characterize the pattern of obstruction. The     investigators will examine the association between DISE and MRI, focusing on specific DISE     findings that have been associated with surgical outcomes. The investigators     multidisciplinary team has substantial expertise and experience in OSA investigation, DISE,     and upper airway MRI.   "
82424|NCT02207114|"     The proposed work will provide critical insights into the potential impact of a     biomarker-based algorithm on reducing unnecessary antibiotic use in different adult and     pediatric/neonatal ICU's. This proposal will also assess the costs (or savings) of a     biomarker-based intervention. Overall, the results of this work will be critical in informing     future strategies to eliminate unnecessary antibiotic use and curb the continued rise in     antimicrobial resistance.   "
82425|NCT02207101|"     Young athletes are usually regarded as a special subgroup of healthy individuals with a     unique lifestyle who are apparently invulnerable and often capable of extraordinary physical     achievement. Most athletic disciplines to some extent combine endurance and strength modes of     physical conditioning. Acute responses to endurance exercise training include substantial     increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood     pressure in-spite of this, high intensity chronic training such as marathons, very long     distance bicycle racing etc., can lead to transient acute volume overload of the atria and     right ventricle, with transient reductions in right ventricular ejection fraction and     elevations of cardiac biomarkers. Although these biomarkers generally normalize back within     seven to ten days, these transient changes may sooner or later mark the beginning of     processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .      Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been     no new advancements in finding an alternate option which can protect the cardio vascular     system in the athletes.      Hence in order to address the need of the hour and also to avoid the cardio vascular risk in     athletes along with improvising the endurance capacity, Enovate Biolife is in the process of     development of an innovative product E-OJ-01.      E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes     by enhancing ejection fraction which in turn improves cardiac output. This finally is     hypothysed to increase the maximal oxygen uptake capacity in athletes.   "
82426|NCT02207088|"     This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week     regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in     HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30,     including those on hemodialysis or peritoneal dialysis.   "
82427|NCT02207075|"     This is pilot study designed to quantifying the innate immune inflammatory burden in a cohort     of secondary progressive multiple sclerosis subjects. Innate immunity is recognized as a     major cause of tissue injury in central nervous system (CNS) disease. Our hypothesis is that     the innate immune response is heightened in SPMS as compared to healthy controls (HC's) and     this activity increases over time and correlates with ongoing neuronal loss and disability.     The investigators will test this hypothesis by using highly specific molecular imaging     techniques, specifically PET, in conjunction with high field MRI. The investigators will     utilize the PET radioligand [11C]PK11195 which will be used as a marker of activated     macrophages/microglia. The investigators will correlate [11C]PK11195 uptake with conventional     measures of inflammation and neuronal integrity on high-resolution MRI.      SPMS subjects will have two baseline [11C]PK-11195 PET scans (separated by 24 to 72 hours,     test-retest) and subsequent scans at 6, 12 and 24 months. SPMS Subjects will have brain MRI's     at baseline, 6, 12 and 24 months.      Healthy Controls will have 2 baseline PET scans and one MRI.   "
82428|NCT02207062|"     This pilot clinical trial studies ibrutinib in treating patients with transformed indolent (a     type of cancer that grows slowly) B-cell non-Hodgkin lymphoma that have returned after a     period of improvement or do not respond to treatment. Ibrutinib may stop the growth of cancer     cells by blocking some of the enzymes (proteins) needed for cell growth.   "
82429|NCT02207049|"     The purpose of this pilot study will be to examine the influence of providing snacks on     consumption of overall energy intake in children aged 2-5 years in the Early Learning Center     (ELC) at the University of Tennessee.   "
82430|NCT02207036|"     This randomized clinical trial will test the efficacy of a Facebook intervention based on the     Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical     Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).   "
82431|NCT02207023|"     The purpose of this study is to examine the efficacy of a lifestyle modification telehealth     program on health-related behaviours in community-dwelling individuals living with stroke.   "
82432|NCT02207010|"     This study would test how much of the new drug, AZD1775, is present in tumor, blood, and skin     after one dose of the drug.      The purpose of the study is not to treat the tumor, but to see if the drug actually gets into     the tumor cells. This study does not replace routine cancer treatment.   "
82433|NCT02206997|"     The aim of the study is to evaluate a patient prewarming concept following the     recommendations of the S3-guideline Prevention of perioperative hypothermia with respect to     incidence and complications of perioperative hypothermia. The study hypothesis is that     postoperative core temperature in adult patients after prewarming is significantly higher     than in patients who were treated following actual standard protocol (passive insulation).   "
82435|NCT02206971|"     The purpose of this study is to examine the impact of providing light smokers with feedback     about their health, including exposure to tobacco-related chemicals.   "
82436|NCT02206958|"     Study Aim:      To determine the feasibility and treatment effect of a multi-component intervention combining     non-drug treatments for urinary incontinence, physical activity, and environmental     modifications to prevent toileting disability in frail older women living in senior housing     facilities.      Hypothesis 1:      Treatment group participants will have a 15% improvement in toileting skills as measured by     the performance on timed toileting instrument compared to no improvement in women assigned to     the no treatment group      Hypothesis 2:      Treatment group participants will have improvements in urinary incontinence severity and     frequency, quality of life related to urinary incontinence, physical function, and barriers     to toileting compared to no improvement in the no treatment group participants   "
82437|NCT02206945|"     The aim of this study is to train patients with obsessive-compulsive disorder to control a     region of their brain that has been associated with their symptoms. Patients in the     experimental group will be given direct feedback regarding activity in this brain area while     they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to     learn to control activity in the region during these feedback sessions. A separate group of     patients will be given a control form of feedback that we do not believe can have clinical     benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms     more than the control feedback.   "
82438|NCT02206932|"     This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and     simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.   "
82439|NCT02206919|"     A major function of blood vessels is to control blood flow by dilating or constricting     depending on the demand. Vascular dysfunction is a state in which blood vessels fail to carry     out its normal roles such as regulating blood flow. Diabetes is a risk factor for vascular     dysfunction. Dysfunction may involve the smaller and/or larger blood vessels. Failure in the     ability of large (conduit) blood vessels to control blood flow may be an early feature of     atherosclerosis, a leading cause of stroke and heart attack. Measures of blood vessel     dilation give an indication of the health of the vessel. Ultrasound and MRI can assess     vascular function by measuring changes in blood vessel dilation. Diabetes may also affect     tiny vessels in the kidney. These vessels become porous allowing albumin (a protein in the     blood) to leak into the urine. The investigators can easily measure the presence of albumin     in the urine.      This study aims to explore if MRI can demonstrate an association between vascular health in     tiny and larger (conduit) blood vessels, by testing for an association between blood flow     regulatory capacity of large vessels and presence of albumin in the urine.   "
82440|NCT02206906|"     Medication adherence is one of the most salient predictors of patient outcomes in the era     following development of effective treatment for HIV infection. Evolving strategies to     improve adherence, specifically incentive interventions and real-time medication monitoring,     have shown some success in limited studies. Further investigation into incentive     interventions for HIV-infected adolescents with poor medication adherence is necessary.   "
82441|NCT02206893|"     Introduction Chronic disease is prevalent and costly in the U.S. (Tu & Cohen, 2009). Poor     eating habit is one factor that account for risk of chronic disease (Arsand, Varmedal, &     Hartvigsen, 2007). Smartphone technology has been promising to improve preventive health     outcomes. However, its great potential has not been widely applied to people's eating     behaviors and its impact is unknown.      Professional and peer supports can improve health status (Elkjaer et al., 2010; Lorig et al.,     1999; Perri, Sears, & Clark, 1993). However, the former is usually delivered didactically or     passively with limited use of smartphones. There is also little evidence of the effect of     peer support delivered by smartphones in the domain of healthy eating. This research aims to     study what smartphone technology can do to upgrade professional and peer supports, and to     evaluate the impact of these mobile-app enabled supports on people's behavior of healthy     eating and user engagement.      Hypotheses      According to Social Cognitive Theory, we hypothesize the following:        1. Mobile-enabled self-monitoring approach improves users' healthy eating behaviors through          improved self-efficacy        2. Professional support improves users' healthy eating behaviors through improved          self-efficacy        3. Peer support improves users' healthy eating behaviors through improved self-efficacy        4. The amount of support is positively correlated with the change in behaviors and their          determinants      Experiment Design The hypotheses will be examined bya 4-month randomized field experiment.     375 subjects will be recruited and assigned to one of the five arms to receive the     corresponding tool for diet management at no cost.      Arm 1: a mobile App with both professional and peer support Arm 2: a mobile App with peer     support only Arm 3: a mobile App with professional support only Arm 4: a mobile App without     any support Arm 5: a non-mobile web App In addition to the App usage data, five surveys are     conducted at baseline and the end of each month. Respondents will be compensated by $8 and a     chance to win $200 for each completed survey.      Interventions        1. All subjects receive the following interventions: an education package includes the          importance of healthy eating, concept of MyPlate, personalized daily food plans;          reminders throughout the study; goal setting capabilities;        2. Self-monitoring provided by an Android App: a heuristic approach inspired by MyPlate to          record their food consumption which allows users to record their meals by images and          doesn't require estimations in cups and ounces; daily reports and trend reports        3. Self-monitoring provided by the web App: a traditional approach to record their food          consumption which requires estimations in cups and ounces, and no images are allowed; no          daily reports and trend reports are provided        4. Professional support provided by a registered dietitian via the Android App: the          supports include the following:             1. Reply to users' messages regarding healthy eating             2. Provide meal-specific comments on subjects' meal consumptions: one meal per week             3. Provide feedback on the subjects' consumption patterns: once per week        5. Peer support provided by other subjects via the Android App: the App provides platforms          for subjects who have the same interest to communicate to each other. The actions the          subjects can do in the platforms include:             1. Post images or texts related to healthy eating             2. Share meals with their ratings             3. Like/dislike others' posts             4. Comment on others' posts e Create groups which allow subjects who have the same               interest to join      Measurements        1. Dependent Variables             1. Eating behavior: a score of healthiness of a meal will be assigned by a dietitian.               The scores obtained by the same subject along the experiment compose the subject's               eating behavior             2. Engaging behavior: this is measured by the number of meals recorded by the subject               in a week. The numbers for the same subject along the experiment compose the               subject's engaging behavior        2. Independent Variables             1. Level of peer support: this will be measured by a score representing the number of               posts, likes, and comments received and given by a subject in a week             2. Level of professional support: this will be measured by a score representing the               number of messages or comments exchanged with the dietitian in a week        3. Mediator Variables: self-efficacy, outcome expectation, and impediments will be measured          by survey instruments      Data        1. User Survey: characteristics and perceptions        2. Mobile App: time, location, and contents of goal setting, meal entries, communications          with professionals and peers        3. Web App: contents of goal setting and meal entries      Analysis Confirmatory factor analysis and statistical modeling such as structural equation     modeling and mixed models will be conducted to test our hypotheses.   "
82442|NCT02206880|"     Delirium is a prevalent complication following cardiac surgery that is under-recognized using     current methods of delirium detection and that may be better identified through a systematic     and standardized perioperative screening protocol.      The purpose of this study is to determine the incidence of postoperative delirium in the     current era of cardiac surgery using a validated delirium-screening tool.   "
82443|NCT02206867|"     To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those     of Humira®.   "
82444|NCT02206854|"     For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study     R-flurbiprofen, will be available as gelatine capsules.      This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine     capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood     samples at different time points. To assess the safety of the administered capsules adverse     events will be documented.      Analysis of lipid signaling molecules in plasma will be done to assess the role of this     molecules as variable for therapeutic effects.   "
82445|NCT02206841|"     This study is designed for establishment of non-alcoholic fatty liver disease patients cohort     to development of markers to predict histologic progression of liver fibrosis.   "
82446|NCT02206828|"     The aim of this Observational Registry Study is to assess the short- and long-term     clinicaloutcomes following the use of Symbotex™ Composite Mesh in primary and incisional     abdominal wall hernia surgeries by open or laparoscopic approach, according to the     Instruction for use (IFU).   "
82447|NCT02206815|"     The aim of this study was to assess safety of antithrombotic drug ticagrelor plus oral     anticoagulation adopted in persistent or permanent AF(Atrial fibrillation)     patients（CHA2DS2VASc≥2） after PCI-S with specially regard to the occurrence of major bleeding     complications. We hypothesized that baseline characteristics (ie age, anemia, previous major     bleeding) and type of antithrombotic regimen could influence any bleeding events and the time     of bleeding occurrence. We will test this hypothesis by comparing those AF patients who     subsequently received double antithrombotic therapy (Ticagrelor + Warfarin) vs. triple     antithrombotic therapy (Clopidogrel + Aspirin + Warfarin) after undergoing PCI-S.   "
82448|NCT02206802|"     The primary purpose of this study is to evaluate the clinical validity of the minoxidil     response in-vitro diagnostic kit.   "
82456|NCT02206698|"     The submitted proposal is designed to reduce morbidity and mortality to injured children.     Significant variability in the initial trauma assessment exists among institutions. The     proposed project is a prospective, observational, multi-institutional study of children     following blunt abdominal trauma. The specific goals of the project are to: 1) Document     history, physical exam findings, imaging, and laboratory values, which are available to     physicians during the initial trauma resuscitation prior to a decision on whether to order an     abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and 2)     Derive and validate a multi-variable clinical prediction rule based on data variables readily     available during the pediatric trauma resuscitation to identify patients at low risk for     intra-abdominal injury, in which unnecessary CT might safely be avoided. Information from     this study could be used to develop a more standardized approach to the evaluation for     intra-abdominal injury following blunt trauma in children. This information could lead to     significant improvement in the early recognition of injury and to improved resource     utilization.   "
82449|NCT02206789|"     Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the     efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk     characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in     preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials &     Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom     satisfactorily meet The inclusion criteria are different for each study Eligible candidates     will be enrolled after signing an Informed Consent form Patients will be randomized into one     of 2 groups        -  Only on topical steroids group A        -  On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized          non-blinded study at a single centre. Methodology In both arms           1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2          weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1          year is completed Systemic steroids may be administered in the initial 2 weeks at the          discretion of the investigators. (For all patients with fungal keratitis topical          steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until          then voveran ophtha may be used           3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day          for 2years           4. All patients will be followed for a minimum period of 2 years           5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3          months until 2 years are completed           6. All episodes of graft rejection will be treated as per accepted norms and the patient          will no longer follow the standardized protocol for steroid administration   "
82450|NCT02206776|"     Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and     impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are     FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and     even then they usually only partially reduce OCD symptoms. The present study, will test if     intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a     comparison medication called midazolam. Therefore, you may or may not receive ketamine as     part of this study. Results from this study will allow doctors and researchers to better     understand if you and others with OCD may respond to this class of medications.   "
82451|NCT02206763|"     This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of     momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of     momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor     (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung     cancer (NSCLC). Participants will be sequentially enrolled to receive progressively     increasing doses of MMB in combination with erlotinib. Escalation of MMB doses will proceed     to the MTD, defined as the highest tested dose associated with dose-limiting toxicities (DLT)     during the first 28 days of combined erlotinib and MMB treatment. There will be four dose     levels and each treatment cycle will consist of 28 days.   "
82452|NCT02206750|"     Purpose:      The purpose of this protocol is to understand how social factors such as psychosocial stress     may modify how people respond to air pollution. Ultimately this will help us understand     health disparities from poor air quality.      Participants:      Up to 40 healthy adults,18-33 years old with different perception of stress will participate     and complete this study.      Procedures (methods):      Subjects will be exposed to clean air and to ozone ( 300ppb) for 2 hours in a controlled     environment chamber. Cardiac, vascular, pulmonary and cognitive function will be evaluated     pre, immediately post and 18 hr post exposure.      The primary endpoint will be Heart Rate Variability . Secondary endpoints will include     pulmonary function, analysis of blood clotting/coagulation factors, biomarkers of stress,     cognitive function, radial artery pulse wave measurements and analysis of soluble factors     present in plasma.   "
82453|NCT02206737|"     Cigarette smoking is associated with poor wound healing and worse results after hand surgery.     Nicotine and cigarette smoke has been shown to affect blood flow in blood vessels in the     hand.      Patients are increasingly using electronic cigarettes (e-cigarettes) as a method of quitting     smoking. E-cigarettes consist of a replaceable nicotine cartridge, a heating element and a     battery source. They are able to deliver vaporised nicotine in the absence of other     ingredients found in normal cigarettes such as tar and carbon monoxide.      Although e-cigarettes lack a lot of the harmful ingredients of regular cigarettes, nicotine     still has toxic effects on the body. Nicotine causes the release of chemicals within the body     that act to reduce blood flow in small blood vessels of the hand.      E-cigarettes remain a controversial topic among healthcare professionals due to the lack of     research surrounding them. A recently published literature review identified only three     significant studies into the effects of smoking e-cigarettes. All of these studies showed the     harmful effects of e-cigarettes on the lungs but to date, there is no published research     investigating the effects of e-cigarettes on the blood flow within the small blood vessels of     the hand.      Currently, we advise patients to quit smoking after they sustain a hand injury to improve     healing and recent research suggests that patients should be advised to quit smoking 4 weeks     before routine hand surgery. However, there is no guidance on whether we should also advice     patients to refrain from using e-cigarettes for this time period.      Our aims are to answer the following questions:        1. Do electronic cigarettes have any effect on the blood flow in the hand?        2. Do we need to give cessation advice to patients with hand injuries who smoke electronic          cigarettes?   "
82454|NCT02206724|"     The investigators aim to test the safety and feasibility of prostate gland stereotactic body     radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.   "
82455|NCT02206711|"     The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and     extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in     healthy male subjects. There is no formal research hypothesis to be statistically tested for     this study.   "
82496|NCT02206178|"     Acetaminophen is one of the most widely used analgesic in the world, recommended for the     symptomatic treatment of fever and pain.      The purpose of this study is to assess the effectiveness of acetaminophen in association with     N-acetylcysteine.      The objective of this study is to evaluate if the association in healthy volunteers of     acetaminophen and N-acétylcystéine        1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control        2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH          enzyme.   "
82457|NCT02206685|"     Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can     affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which     is a measurement used for evaluation of curves in scoliosis on an anterior-posterior     radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40     degrees in the lumbar region) or when the curvature causes significant pain, or respiratory     and cardiovascular restriction. Patient undergoing this surgical correction experience severe     pain in the postoperative period and the management includes the use of opioid-based     patient-controlled analgesia (PCA).   "
82458|NCT02206672|"     This prospective single-center study evaluates a current care procedure. It includes 14     patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger     criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their     face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale 0-48),     a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth opening     less than 55 millimeters. They should not have anticoagulant, anti-platelets aggregation     medication or a daily steroid dose upper 20mg per day. Their BMI should exceed 17.      Micro fat grafting is a minimally invasive and usual procedure performed under local     anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm diameter     cannula from areas around the knees, the abdomen or the hips under a gentle aspiration.     Lipoaspirated fat is then filtrated by the PureGraft system that offers a sterile, closed,     single-use system, leading to a fast, consistent and controlled preparation. Then, 10 to 25     milliliters of this purified fat product is transferred through a 21 gauge or 0.8 mm diameter     cannula in two or four points of the face, with the entry points located around the mouth.   "
82459|NCT02206659|"     To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure     monitoring in Chinese patients with mild to moderate essential hypertension   "
82460|NCT02206646|"     To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial     infarction over a period of 6 years as required by Korean authorities, with the following     observations:        1. Unexpected adverse drug reactions        2. Frequency and nature of adverse events (AEs)        3. Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of          Metalyse® was also assessed.   "
82461|NCT02206633|"     The study will aim to determine normal daily variation of the individual hydration level in     longitudinal study on elderly in assisted living facility and assess a range of variation of     individual hydration baselines for elderly in a normal physiologically hydrated state.   "
82462|NCT02206620|"     This study will compare the effects of placebo and donepezil, a drug that helps conserve     concentrations of the neurotransmitter, acetylcholine on measures of balance and gait in     subjects with Parkinson's disease (PD). This study is a double-blind, placebo controlled,     cross-over randomized clinical trial. Short-latency afferent inhibition (SAI), a     physiological index of cholinergic function will be measured to determine if the deficits in     balance and gait correlate with abnormalities of the SAI and if SAI is altered by donepezil     as a measure of drug efficacy. Cognitive tests like the attention network test will be     administered to determine if changes in gait and balance are mediated by changes in     attention.      The results of this study will be the most direct test of the hypothesized role of     cholinergic neurons and the neurotransmitter, acetylcholine in terms of gait and balance. The     study is exploratory because it is not known whether donepezil will affect gait, balance or     attention, nor which measures of gait, balance or attention will be sensitive to drug     manipulation. The study's immediate goal is to determine the potential utility of cholinergic     manipulation as a strategy for preventing or treating balance and gait dysfunction in PD. The     findings of this trial are intended to lead to more sharply focused questions about the role     of cholinergic neurons in balance and gait and eventually to Phase II B trials to determine     clinical utility of cholinergic manipulation to prevent falls and improve mobility.   "
82463|NCT02206607|"     Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three     modified release formulations of PF-04937319 compared with the immediate release     material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.   "
82464|NCT02206594|"     A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment     of Fuchs' corneal dystrophy.   "
82465|NCT02206581|"     The study will aim to evaluate the correlation between changes in ultrasound velocity and     measures of hydration status including urine specific gravity, plasma and urine osmolality in     male and female young adults after undergoing an acute dehydration and rehydration. The study     will also test the hypothesis that body dehydration is a generalized physiological process     equally affected all body muscles by comparing the data obtained on calf and biceps muscles.   "
82466|NCT02206568|"     To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).   "
82467|NCT02206555|"     Significant increases in HIV diagnoses among gay and other homosexually active men, in     Australia and internationally, have been observed since the late 1990s. The levels of high     HIV risk sexual practices among gay men have also increased, particularly unprotected anal     intercourse (UAI). Nationally, over three quarters of the new HIV infections diagnosed     annually are among men who have sex with men (MSM). The proportion of heterosexual men and     women among those diagnosed with HIV annually has also increased in recent years. Despite     successes in some situations, HIV transmission has not been adequately reduced by the     prevention methods available to those at risk, such as education, condoms, and treatment of     sexually transmitted infections (STIs).      The effectiveness of daily oral antiretroviral medications (ARVs) as preexposure prophylaxis     of HIV (PrEP) has now been established by clinical trials in both heterosexual adults and     homosexual men. Whether PrEP confers high rates of protection in real life situations and is     a feasible strategy to implement still requires further investigation. Through its HIV     prevention strategy 2015: New era, NSW Health committed to consider how to most     appropriately and efficiently implement PrEP in line with evidence. This commitment     translated in the support to this PrEP demonstration project.      This demonstration project is designed to evaluate the off-label provision of daily     combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known as TRUVADA) as     PrEP to a sample of sero-negative individuals at high risk for HIV infection in clinical     settings in New South Wales. The project will inform policy development regarding primary HIV     prevention with PrEP.      This is an open-label, single-arm treatment evaluation study. All consenting and eligible HIV     negative participants will receive TRUVADA prescribed for daily administration orally. At     each followup visit, the following procedures will be conducted: clinical evaluations/     procedures, laboratory evaluations/ procedures, testing for HIV, STIs, hepatic and renal     function, assessment for adherence to the prescribed medication, side effects, eligibility     for next TRUVADA prescription, and willingness to continue on PrEP.      As a study requirement, participants will be offered a self-administered assessment of     behaviour, lifestyle and attitudes which will be conducted ideally within two and no more     than seven days of the clinic visit in the participant's private space.      Analyses will include: the feasibility of PrEP delivery, adherence to the study medication,     safety and tolerability, the effects of PrEP use on behavior, and statistical analyses of the     risk of HIV seroconversion.   "
82468|NCT02206542|"     Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly     seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively     prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and     disability. These patients need early and regular rehabilitation to regain their function and     prevent unnecessary complications such as contracture and disuse atrophy. Proper     rehabilitation is important but the challenge is also great. However, rehabilitation training     is a very labor-intensive task in which one to one treatment is essential and that will     restrict the number of patients served. Moreover, patients receiving home programs are     difficult to supervise, resulting in reduced training effect and delayed functional recovery.     In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of     rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of     upper-limb exoskeleton rehabilitation robot and its related technology and human-robot     interaction. This robot is used to serve the rehabilitation need of those patients suffering     from upper extremities dysfunctions and also can provide careful designed therapeutic program     of upper limbs including shoulder and elbow joint exercises. Its control software also     provides a therapeutic management system with intelligence and ergonomic consideration. This     work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for     both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The     clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and     finally approved by Department of Health (DOH) in April 2011. This team had completed the     clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon     this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen     Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.   "
82469|NCT02206529|"     The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that     will be integrated into a standard treatment program for childhood overweight. The     investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its     effectiveness compared with historical controls who received standard treatment. The     historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use     of Strategies; NCT00746629).   "
82470|NCT02206516|"     This study aims at combining imaging techniques and clinical evaluations to assess clinical     change as well as brain changes that occur as a result of brain stimulation in adult     attention deficit disorder.   "
82471|NCT02206503|"     This study evaluates the efficacy of the addiction of Cyclophosphamide to Revlimid-low dose     dexamethasone (Rd) in relapsed/refractory Multiple Myeloma patients, who experienced a     biochemical progression, without CRAB, during Rd treatment.   "
82472|NCT02206490|"     Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments     with FDA approved generic drugs are being administered to see if they help with the symptoms     of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and     thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are     dextromethorphan and naltrexone.   "
82473|NCT02206477|"     Capsular contraction is the one of the most common complications of both esthetic and     reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the     contraction is unclear, but is believed to be similar to the formation of hypertrophic     scarring.      Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory,     anti-proliferative, and antibacterial agent.      The aim of this study is to test the effect of DMSO on the incidence and severity if capsular     contracture after breast alloplastic reconstruction in irradiated patients.      We conduct a prospective randomized-control single-surgeon study in the tertiary academic     Rabin Medical Center.      110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction     will be included. They will be divided into two groups: the DMSO treatment group, which will     be treated according to our protocol, and the control group, that will be treated with the     same protocol but with 0.9% saline instead.      Several measures will be taken, including: capsular contracture grading by two plastic     surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography     evaluation, and pathology examination of the capsule (biopsy will be taken during the second     stage operation).      Rates and grades of capsular contracture evident clinically, radiologically and     pathologically, will be evaluated and compared.   "
82474|NCT02206464|"     Background:<TAB>      - Flu virus that causes disease in birds can sometimes spread to people. It can cause severe     illness, even death. Vaccines are used to try to create resistance to such infections.     Researchers want to test a new vaccination strategy, combining two different vaccine types,     the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one     of two combinations offer better protection against a certain type of bird flu in humans when     compared to vaccination using two doses of MIV alone.      Objectives:        -  To see if 2 vaccines for bird flu, are safe and tolerable for humans.        -  To study immune responses to these vaccines.      Eligibility:      - Healthy adults 18 60 years old.      Design:        -  Participants will be screened through a separate protocol.        -  Participants will be randomly assigned to 1 of 3 groups. Each group will get a different          combination of vaccines.        -  Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be          drawn at some visits. Urine samples may be collected.        -  Participants will receive vaccinations at 2 of the visits, 16 weeks apart.        -  The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA          vaccine will be injected in the upper arm using a device that delivers the vaccine          through the skin by pressure instead of a needle.        -  Participants will be observed for at least 30 minutes after each vaccination.        -  Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for          evaluation, and complete a diary at home for 1 week. They will record their temperature          and symptoms and look at the injection site daily.        -  Participants will have follow-up blood tests.   "
82497|NCT02206165|"     The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine     combined or alone and select better dose of CKD-330 in essential hypertension patients.   "
82498|NCT02206152|"     This is a single center, double blind randomized cross over design trial that will compare     the impact of N-acetyl cysteine (200 mg) vs. saline infusion during experimental hypoglycemia     on day one on the responses to experimental hypoglycemia on day two. 18 participants will be     studied twice, 8 weeks apart. On each occasion they will undergo a 2 hour hypoglycemic clamp     (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the     morning of day 2 and day 3. During the morning clamps, samples will be collected for later     measurement of serum epinephrine levels, plasma and red blood cell NAC, cysteine, and     glutathione concentrations and GSH/GSSG ratios (redox status), and participants will be asked     to complete a hypoglycemia symptom questionnaire   "
82475|NCT02206451|"     Background:      - Malaria is a disease that affects many people in Mali and in Africa. It is caused by germs     that are spread by mosquito bites. Researchers are creating vaccines that they hope will     prevent malaria infection and/or the spread of it.      Objective:      - To test if the PfSPZ vaccine can stop malaria spread by mosquitoes.      Eligibility:      - People currently enrolled in the ongoing PfSPZ malaria vaccine trial. Participants must be     willing to have uninfected mosquitoes bite them.      Design:        -  Participants will be able to take part in this study at every visit after receiving all          scheduled vaccinations.        -  Participants will be asked whether they are willing to participate in the procedures.          Female participants will have a pregnancy test.        -  Researchers will put about 60 mosquitoes in 2 or 3 cups (20 or 30 in each cup). They          will hold each cup to the participant s leg or arm so the mosquitoes can bite. These          mosquitoes do not carry germs and will take about 3 drops of blood total.        -  Participants will get a cream for any swelling or itching.        -  Participants will be checked the next day for any discomfort.        -  Participants may take part in this feeding test multiple times, if they are willing.        -  If participants have malaria parasites in their blood, they may be asked to take part in          another study. For this, they will sleep alone in their hut the night after the feeding          test. A study team will set up nets to collect mosquitoes that may have bitten the          participant overnight.   "
82476|NCT02206438|"     Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these     devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q     (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that     may optimise the airway sealing while reducing the potential for postoperative complications     such as sore throat. The overall structure of the air-Q SP is identical to the original     air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to     compare the clinical performance of the classic LMA and the air-Q SP.   "
82477|NCT02206425|"     The goal of this clinical research study is to evaluate the safety and effectiveness (good     and bad effects) of ixazomib given as part of a combination therapy to treat subjects with     relapsed (subjects whose disease came back) or refractory (subjects whose disease did not     respond to past treatment) multiple myeloma. More specifically, the study is focused on     subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®)     and showed worsening of their myeloma while receiving either one of these drugs in     combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which     means that ixazomib is currently being tested and is not yet approved by the United States     Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma.     Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib;     however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies     investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for     the treatment of multiple myeloma both on its own and in combination with other multiple     myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.   "
82478|NCT02206412|"     High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and     has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is     released by inflammatory cells actively, or increased during cell death passively and     mediates inflammatory response. It has been reported to have association with the prognosis     after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and     heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and     post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.   "
82479|NCT02206399|"     The investigators clinical trials will be for a medical device that is non-invasive in     nature. The investigators will be studying whether their non-invasive medical device gets     data that is as good as, or better than, an FDA previously approved, blood analysis device.     There is no study hypothesis for this study.   "
82480|NCT02206386|"     To identify effective implementation strategies that can efficiently promote the use of     evidence-based practices (EBP) across a large number of geographically dispersed, independent     Home Health Agencies (HHAs). This study will use an agency-randomized design to test the     effectiveness of a web-based implementation strategy (MHTraining-Net) on the use of an     evidence-based practice for geriatric depression by home healthcare agencies. The EBP is     known as the Depression CARE for PATients at Home (CAREPATH) Intervention. The effectiveness     of MHTraining-Net will be measured by an agency's adherence to the Depression CAREPATH     protocol with its depressed patients and changes in their patients' depressive symptoms over     the episode of care.   "
82481|NCT02206373|"     Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there     are many factors that may affect the measurement of serum creatinine, it is a well-accepted     marker for renal function assessment. The creatinine clearance (ClCr) estimated by     Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated     glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in     CKD staging. ClCr and eGFR not only have different units, but the results of estimation from     the two varied among races and individuals. Since 2010, US Food and Drug Administration     required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal     insufficient patients during pharmacokinetic studies. Because most drugs are excreted through     kidney, an understanding on the relationship between ClCr and eGFR is important to dose     safely and effectively. Furthermore, identifying the factors that may influence the     difference between ClCr and eGFR can provide in-depth consideration during clinical renal     function assessment.      Purpose： The purpose of this study is to analyze the correlation between different ClCr and     eGFR equations in order to provide better renal dose. We also want to find the factors that     may cause the differences between them.      Methods： This study will conduct literature review to understand study population during the     development of different ClCr and eGFR equations, as well as their scope of application.     National Taiwan University Hospital electronic patient database will be used to analyze the     correlation between ClCr and eGFR and to identify factors that may influence the difference     between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine     collection with calculated renal function will be used to verify the applicability of these     equations (including a ClCr equation developed by our institute) in Taiwanese.     Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal     function while dosing a patient.   "
82482|NCT02206360|"     Early detection testing is recommended for individuals at elevated risk for the development     of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to     or greater than five times the general population risk, or five times the average risk (1.5%)     of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion     criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of     hereditary cancer genes, as well as by family history. Enrolled subjects will undergo     Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to     12 months, for up to 5 years.   "
82483|NCT02206347|"     Postural-suprapostural task is defined as postural control takes place while at least one     other concurrent task is being performed, and appropriate locus of attentional allocation is     considered a critical factor for successful postural-suprapostural execution. Recent studies     have indicated that the behavior performance of postural-suprapostural task would be affected     by the prioritization of attentional allocation (postural-first vs. suprapostural-first);     however, the inference of the appropriateness of attention prioritization is primarily     limited to behavior observations and lacks direct neural evidences. How the effect of     attentional priority between postural and suprapostural tasks on postural-suprapostural     performance and its underlying cortical mechanism is rarely understood. By adopting     postural-first and suprapostural-first strategies for postural-suprapostural task, the     purpose of this 2-year research project is to 1) investigate the differences in performance     quality and intrinsic neural mechanisms effect of a postural-suprapostural task for healthy     adults with the analysis of event-related potential (ERP) and non-linear dynamics of behavior     measures; 2) investigate brain plastic changes and the appropriateness of strategy use. In     the first year, the attention prioritization effect on reciprocity of a     postural-suprapostural task will be characterized by integrating the results of behavior     performance and ERP causal connectivity with a special focus on validation of prevailing     theoretical models. In the second year, the difference of task fluent for learning a     postural-suprapostural task with postural-first/suprapostural-first strategy will be studied     through the spatial and time variations in alpha rhythm after principle component analysis.     The present project is expected to have significant contributions not only to gain a better     insight to neural correlates of concurrent postural and motor suprapostural tasks, but to     optimize treatment strategy for patients with balance or multi-tasking disturbances.   "
82484|NCT02206334|"     This phase I trial studies the side effects and the best dose of stereotactic body radiation     therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate     cancer that has spread to other parts of the body. Stereotactic body radiation therapy     delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer     in the body while minimizing radiation exposure of surrounding normal tissue.   "
82485|NCT02206321|"     1. Prospective follow-up and comparative analysis of early, midterm, and long-term surgical          results and complications between navigation assisted TKA and conventional TKA.        2. Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from          blood, tissues, and drainage between navigation assisted TKA and conventional TKA.        3. Prospective follow-up of surgical results of navigation-assisted TKA.   "
82486|NCT02206308|"     The purpose of this study is to determine whether SCT400 is safe and effective in the     treatment of B-cell Non Hodgkin's lymphoma   "
82487|NCT02206295|"     The primary aim of this study is to demonstrate bioequivalence in the rate and extent of     absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of     1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8     film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a     multiple-dose up-titration scheme.   "
82488|NCT02206282|"     A prospective clinical research is to assess the prevalence of implant rupture and presence     of extracapsular gel in an un-referred population of women who have been implanted with the     Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.   "
82489|NCT02206269|"     The objective of this Registry is to collect real-world outcome data for bronchial     thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic     despite taking standard of care maintenance medications.   "
82490|NCT02206256|"     Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method     to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery     are routinely pre-treated with a low calorie diet in order to reduce liver volume and to     facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty     acids has similar effects on liver volume, but a prospective comparison of both treatments     has not been performed yet. Morbidly obese patients respond differently to surgical stress,     due to a number of factors. First, obesity is associated with a low-grade inflammatory state     induced by an increased amount of macrophages in adipose tissue. This state is associated     with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune     response to infections. Second, obesity is associated with an altered cortisol metabolism     possibly related to adrenal insufficiency. This could play an important role in the altered     response to surgical stress and postoperative complications in obese subjects. Third, obesity     is associated with altered erythrocyte function, including decreased erythrocyte     deformability and increased aggregation, factors contributing to an impaired     microcirculation.      This study has a number of different aims. First, we will compare pre-treatment with the     standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for     gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of     omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the     stress response of obese subjects before and erythrocyte function. Third, we will investigate     the effect of gastric bypass surgery by comparing values before surgery with values on the     first postoperative day and 6 months after surgery regarding to immunological parameters,     stress response and erythrocyte function.   "
82491|NCT02206243|"     The purpose of this observational study is to evaluate the prostatic arterial embolization     (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the     treatment of symptomatic benign prostatic hyperplasia (BPH).   "
82492|NCT02206230|"     This study is being done to compare standard radiation therapy with hypofractionated     radiation therapy for patients with newly diagnosed glioblastoma   "
82493|NCT02206217|"     The purpose of this study is to determine if the Multiple-Segment (MS) lens can slow myopia     progression in Hong Kong schoolchildren.   "
82494|NCT02206204|"     This is a single-center, double-blind, randomized, placebo- and positive-controlled,     double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over     comparison between moxifloxacin and placebo in healthy male and female subjects. The primary     objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an     effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally     administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects.     Moxifloxacin is included as a positive control.   "
82495|NCT02206191|"     In response to the high prevalence rates of childhood obesity in central Ohio, the Center for     Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a     partnership between primary care physicians and Nationwide Children's Hospital's Center for     Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in Ohio.     The overall goal of PCON is to bring an effective and user friendly obesity management     program to the community physician's office to prevent and treat the growing number of obese     children in the setting of the private office. The predominant nutrition messaging approach     to tackling childhood obesity has revolved around the food choices and portion sizes. While     this is relevant, an area with significant potential for impact for maintaining optimal     growth and a healthy weight for young children is addressing feeding behaviors and     self-regulation of intake;. - the how of eating. The investigators objective it to     investigate whether this self-regulation approach can be employed for an older age group of     6-11 years old.   "
82509|NCT02206009|"     Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?   "
82754|NCT02202824|"     The objective of our study was to determine the extent to which contextual information about     the circumstances of intimate partner violence affects participants' responses to questions     about their personal attitudes toward intimate partner violence.   "
82499|NCT02206139|"     The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article     entitled Staff Burnout in which he discussed job dissatisfaction precipitated by     work-related stress. A broadly applicable description defines burnout as a state of mental     and physical exhaustion related to work or care giving activities. A long-standing conceptual     and operational definition characterized burnout as a triad of emotional exhaustion     (emotional over extension and exhaustion), depersonalization (negative, callous, and detached     responses to others), and reduced personal accomplishment (feelings of competence and     achievement in one's work) In the World Health Organization International Classification of     Diseases, 10th revision, burnout is defined as a state of vital exhaustion. Although no     specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental     Disorders, burnout is a clear syndrome with significant consequences.      Burnout in health care professionals has gained significant attention over the last several     years. Given the intense emotional demands of the work environment, clinicians are     particularly susceptible to developing burnout above and beyond usual workplace stress.     Residency training, in particular, can cause a significant degree of burnout, leading to     interference with individuals' ability to establish rapport, sort through diagnostic     dilemmas, and work though complex treatment decision making. Overall, burnout is associated     with a variety of negative consequences including depression, risk of medical errors, and     negative effects on patient safety. The goal of this review is to provide medical educators     and leaders with an overview of the existing factors that contribute to burnout, the impact     of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.   "
82500|NCT02206126|"     The purpose of this study is to evaluate the effects of moderate energy restriction on the     body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress,     inflammatory biomarkers, metabolic profile and endothelial function in obese patients with     OSA.   "
82501|NCT02206113|"     A 16 week pilot study for Allina call center employees to look at the psychological outcomes     and biological markers after an intervention of using a standing work station. There were two     groups: group 1 received, and was instructed to use, the standing work station for all 16     weeks, group 2 was a wait-list control group and received, and was instructed to use, the     standing work station for the second 8 weeks. Psychological outcomes were measured at weeks     0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.   "
82502|NCT02206100|"     PER977 administration following a single subcutaneous (sc) dose of enoxaparin 1.5 mg/kg will     have an acceptable safety and tolerability profile with no impact on pro-coagulant     biomarkers.   "
82503|NCT02206087|"     Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with     dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of     PER977 followed by a one-week washout and then will receive unfractionated heparin followed     by a single dose of PER977. The study will provide some insight into the doses that may be     required to reverse anticoagulation induced by heparin. PER977 administration following     heparin sodium injection will have an acceptable safety and tolerability profile with no     impact on pro-coagulant biomarkers.   "
82504|NCT02206074|"     The investigators are conducting a research study to see if increasing the amount of nitrate     (a substance found in large quantities in certain vegetables) in the diet can increase the     ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D     find exercise more uncomfortable than individuals who do not have T2D. This may be explained     by the experimental studies showing that T2D can result in reductions in the supply of oxygen     to the muscles. Studies have also shown that for a given level of activity, individuals with     T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary     nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of     dietary nitrate on the responses to exercise may have a significant impact on the ability of     individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2)     experimental studies suggest that increased nitrate consumption has been shown to reduce the     amount of oxygen required for a given level of exercise.      The investigators will recruit 60 individuals with T2D. These people will take part in a     randomised crossover design study where they will be asked to drink normal beetroot juice     (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different     walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking).     This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen     required for a given level of exercise in individuals with T2D. To test brain function     individuals will be asked to perform a standard computerised decision making task following     consumption of the nitrate rich and nitrate depleted juices.   "
82505|NCT02206061|"     The goal of this study is to evaluate the widespread implementation of a developmentally     appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care     for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed     therapy (DOT) to allow the teen to experience the potential benefits from adhering to     guideline-based asthma treatment, and 2) a developmentally appropriate Motivational     Interviewing (MI) Counseling Intervention to help the teen transition to independent     long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT     program will 1) experience less asthma-related morbidity than an asthma education (AE)     attention-control comparison group, and 2) have improved adherence, less urgent healthcare     use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The     investigators also hypothesize that participants receiving DOT-only will have improved     asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but     will not have sustained, clinically significant improvement in outcomes once the DOT phase is     complete. This represents a unique opportunity to build upon existing community relationships     with an innovative and developmentally focused program to improve asthma outcomes for urban     teens.   "
82506|NCT02206048|"     The goal of this clinical research study is to learn if it is possible to get high-resolution     microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right     before a biopsy of the cervix. Researchers also want to learn if HRME images can show the     difference between cancerous tissue and normal cervical tissue.   "
82507|NCT02206035|"     This is a phase II open label trial designed to evaluate the efficacy of Tac/MTX/Toc in     preventing graft versus host disease (GVHD). Outcomes of patients on this clinical trial will     be compared to those of contemporary controls from the CIBMTR.   "
82508|NCT02206022|"     At present, there is no reference protocol for Central Venous Catheter (CVC) insertion     assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and     anesthesia to realize this gesture, from single local anesthesia to general anesthesia.     Remifentanil has been shown to decrease pain scores for insertion and removal of long-term     central venous access. Remifentanil is also often employed for pediatric or labor analgesia     for short acts as procedural sedation.   "
82510|NCT02205996|"     Strict glycaemic control has been associated with increased hypoglycaemia and mortality rate,     the cause of which was unclear, in subjects with type 2 diabetes. In this study, we     hypothesised that acute hypoglycaemia will result in platelet activation in people with type     2 diabetes to a higher degree than controls.   "
82511|NCT02205983|"     In this study, the investigators will examine the effects of buprenorphine, as compared to     placebo, upon physiological, subjective, and hormonal responses to a stressful speech task     and a non-stressful control task in healthy adults. There is strong evidence in support of     the role of endogenous opioids and opiates in mediating social behavior in humans and other     animals, and particularly, in social distress. The investigators have recently shown that     buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the     investigators propose to further explore the role of the opioid system in mediating stress     responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition     to buprenorphine. The investigators hypothesize that like buprenorphine, hydromorphone will     reduce both physiological and subjective measures of stress.   "
82512|NCT02205970|"     The present study aims to verify the analgesic potential of a new methodological proposal for     application for transcutaneous electrical nerve stimulation (TENS interactive) using patients     with primary dysmenorrhoea and compare it with placebo in a randomized double blind study     with convenience sample.   "
82513|NCT02205957|"     Opinion survey to assess the level of satisfaction and the expectations of the residents in     anesthesiology and intensive care in Tunisia ( North Africa)   "
82514|NCT02205944|"     The purpose of this research study is to determine whether two different types of forearm     exercise, performed before fistula creation surgery, can improve surgery success and fistula     maturation.   "
82515|NCT02205931|"     Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the     most common chronic neurological disorder in children. Epilepsy onset is most common in the     first two years of life and is associated with poor prognosis for seizure control and     neurodevelopmental outcome.      The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in     carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in     children with epilepsy older than two. Associated benefits include: a reduced requirement for     routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital     admissions. Although reports suggest that KD therapy improves seizures in younger children     there is no high quality trial data that demonstrates effectiveness and safety in this age     group. The KD is resource intensive, requiring dietetic and physician time; data is required     to justify expansion of services to cater for the apparent need.      The investigators therefore propose a prospective multicentre randomised trial to investigate     the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have     failed to respond to two or more AEDs. Children will be randomly assigned to either receive     the KD or further AEDs. The allocated treatment will be started after a 2week baseline     period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record     seizures and related events, a questionnaire will be used to assess diet tolerance; also     growth and blood biochemistry will be monitored.      The information obtained from this study is necessary to optimise choices in epilepsy     treatment, aiming to improve outcomes and thus determine whether and when the KD should     should be used.   "
82516|NCT02205918|"     The purpose of this study is to examine how the brain and environment interact to influence     children's ability to suppress tics using a medical technology called Transcranial Magnetic     Stimulation (TMS).   "
82517|NCT02205905|"     This is an open-label, single-dose, non-randomized study in healthy male subjects to     characterize the mass balance, metabolic disposition, and identification of the metabolites     and general metabolic pathways following administration of a single dose of IV solution     containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.   "
82518|NCT02205892|"     Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of     inflammatory and non-inflammatory acne lesions in split face fashion   "
82519|NCT02205879|"     The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking     and reducing drinking severity   "
82520|NCT02205866|"     This study evaluates the incidence of Non Receptive endometrium in obese infertile women     compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test,     containing 238 genes, identifying the receptivity status of an endometrial sample and     diagnosing the patient's Window of Implantation, regardless of the histological appearance of     the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural     cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.   "
82521|NCT02205853|"     The aim of this study is to develop and identify the most effective strategy to implement     PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared     with a single-faceted patient-directed strategy.   "
82522|NCT02205840|"     The purpose of this study is to assess the safety and effectiveness of SI-614 solution     compared with placebo solution in treating patients with dry eye.   "
82523|NCT02205827|"     The purpose of the study is to characterize the distribution and sources of variability in     whole blood clotting time (WBCT) measurements in human blood collected from healthy     volunteers by 5 different technicians.   "
82546|NCT02205528|"     This trial is conducted in the United States of America (USA). The aim of the trial is to     investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC) injections     of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with T2D.   "
82570|NCT02205216|"     Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and     responds often incompletely to conventional therapy. The pathogenesis remains largely unknown     and therapeutic alternatives are needed. Rehabilitative interventions that consist of     learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent     the most efficacious intervention, but difficulties in learning and execution of these     cognitive strategies are the main cause of failure. Transcranial direct current stimulation     (tDCS) enhances motor task learning and execution in patients with PD and might enhance the     efficacy of rehabilitative interventions.      This study intends to address the following question whether tDCS can enhance the efficacy of     rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?   "
82524|NCT02205814|"     This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm,     dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy,     safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of     fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.      Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a     clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a     total of 4 treatment arms. Each arm includes a single intra-articular injection of one of     three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation     ratio will be 1:1:1:1.      The primary efficacy variable will be the change of the Western Ontario and McMaster     Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline     up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and     clinical laboratory tests; local tolerability at the injection site will also be assessed. In     addition, the population pharmacokinetics and the exposure-response relationship will be     evaluated.      The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7     planned visits at site, including screening, randomisation, 4 follow-up visits and the End of     study visit.   "
82525|NCT02205801|"     We aim to study the effect of local anesthetic when used in conjunction with general     anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain     control between bilateral superficial cervical plexus block and local wound infiltration when     used in conjunction with a general anesthetic.   "
82526|NCT02205788|"     The purpose of this study is to determine if you can use an assay on tumor samples to see     different patterns in response to the same chemotherapy treatment.   "
82527|NCT02205775|"     Myocardial necrosis is relatively frequent after percutaneous coronary intervention and is     associated with higher mortality during the follow-up.      Since anti-inflammatory properties of statins have been demonstrated and the benefit of     statins in acute coronary syndromes have been proven, this study aims at testing the     hypothesis that the pre-procedural intensive statin treatment reduce the extent of     peri-procedural necrosis.   "
82528|NCT02205762|"     The LCH-IV is an international, multicenter, prospective clinical study for pediatric     Langerhans Cell Histiocytosis LCH (age < 18 years).   "
82529|NCT02205749|"     Research with stored biospecimens can provide substantial societal benefits, including     greater understanding of cancer etiology and discovery of new cancer therapies, but one     critical social and ethical issue is the use of samples for research unplanned at the time of     biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out, broad     consent, study-specific consent) have been proposed for secondary research use of     biospecimens, but empirical data on individuals' preferences for different consent models are     limited, particularly from those with limited health literacy and from racial and ethnic     minority groups. It is critically important to understand the consent preferences of diverse     individuals, as participation of all population subgroups in biobanks is essential to reach     translational cancer research goals. Based on a social ecological conceptual framework, the     investigators will examine preferences for consent models for secondary research uses of     biospecimens among a racially and socioeconomically diverse sample of women 35 years of age     and older. The investigators aim to compare experimentally the effect of consent model on     intentions to donate biospecimens for future research use among a diverse sample of women.     The investigators hypothesize that women will have stronger intentions to donate based on the     broad model of consent and the study-specific model of consent compared with the notice model     of consent. These findings from groups underrepresented in research will be critical since     the participation of these groups in biobanks is essential to generating findings that will     achieve translational research goals of eliminating cancer disparities.   "
82530|NCT02205736|"     Subjects will be recruited from the participants in the Union and Mecklenburg County Living     Room Visits. Participants in the Living Room Visit will have been recruited using community     event flyers. During the Living Room Visits, the Health Educator will provide a general     overview of the study. Individuals who are interested in participating in the study will then     be generally screened for eligibility by the Protocol Coordinator who will then proceed to     provide informed consent to potential subjects.   "
82531|NCT02205723|"     The objective of this protocol is to pilot an innovative approach to medication adherence to     determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence,     a critical gap in improving the health of children with asthma. SNAPP incorporates     monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS     medication adherence and that the investigators believe will influence the child's future     independence and chronic disease-management skills.   "
82532|NCT02205710|"     Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate     cognitive function in older adults and individuals with dementia. In recent years, such     training has become particularly appealing in the clinical context, with many paradigms aimed     specifically at adults experiencing various stages of cognitive decline due to Mild Cognitive     Impairment, Alzheimer's disease, and vascular dementias. However, basic questions remain. For     example, uncertainty persists regarding factors that influence observed improvements as well     as the conditions that would maximize transfer and sustainability of training effects. The     objective of this study is to evaluate factors that may maximize the benefits of computerized     cognitive training in older adults.   "
82556|NCT02205398|"     This is an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the     orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination     was to be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on     cetuximab or panitumumab treatment. The dose escalation part was to be guided by a Bayesian     Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC     patients who progressed on cetuximab or panitumumab treatment were to be enrolled in two     expansion groups to further assess the anti-tumor activity and the safety and tolerability of     the combination of INC280 and cetuximab. Patients were tol receive INC280 on a continuous bid     dosing regimen and cetuximab every week. A treatment cycle was defined as 28 days with no     scheduled break between cycles.      The trial was terminated because of difficulties in identifying patients who met the     eligibility criteria.   "
82533|NCT02205697|"     Diet quality has been associated with a variety of chronic diseases including obesity. One     measure that has been studied as an indicator for diet quality is fruit and vegetable intake.     Although the US government has suggested that American's increase their intake of fruit and     vegetables, epidemiological data suggest that most Americans have not been successful doing     do, with the strongest disparity seen in people of low socioeconomic status (SES). This     disparity in fruit and vegetable intake is thought to be the result of both individual and     environmental factors that influence this health behavior. To help decrease the disparate     rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy     to implement interventions to improve fruit and vegetable intake and diet quality are needed.      Theoretical models of health behavior change have been successfully used in research     targeting individual factors associated with health behaviors. One theory, the Theory of     Planned Behavior (TPB), and a proposed extension of this model (implementation intentions)     have been shown to be effective to increase fruit and vegetable intake in (mostly) white     adults of average socioeconomic status. It is not know whether an implementation intention     intervention to increase fruit and vegetable intake would be effective in women who are of     low socioeconomic status. The primary aim of this research is to study (using quantitative     and qualitative analysis) an implementation intention intervention to produce a positive     change in fruit and vegetable intake. We theorize that the setting of an implementation     intention in this group will be effective, cost-effective, and easy to implement intervention     to promote an increase in fruit and vegetable intake.   "
82534|NCT02205684|"     Physical health problems are common in schizophrenia with a two- to three-fold increased     morbidity and mortality rate, resulting in a 20 years reduction in life expectancy. A genetic     vulnerability for developing cardiovascular disease has been documented in these patients,     and many lifestyle factors also negatively influence physical health. Patients with     schizophrenia are likely to smoke, are physically inactive and overweight, suffer from     malnutrition due to unhealthy diet, and have reduced cardiorespiratory fitness. Moreover,     these patients have increased risk of developing diabetes mellitus type II and metabolic     syndrome. These aspects demonstrate the need for multi-disciplinary treatments of patients     with schizophrenia and underline the need for addressing their physical health.      Poor physical fitness seems to be associated with exacerbated negative symptoms and increased     cognitive dysfunction in patients with schizophrenia. However, evidence on physical activity     and its consequences in schizophrenia is scarce. In this randomized controlled trial we     investigate the effects of high intensity training in outpatients with schizophrenia on     psychotic symptoms and well-being, cognition and cortical structure, tobacco smoking and     substance use, in addition to metabolic indices.   "
82535|NCT02205671|"     The program consists of a 6-week small-group workshop for caregivers of people with memory     problems.      The goal of the study is to evaluate in a one year longitudinal study, program effectiveness     in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving     sleep, healthful behaviors and self-efficacy   "
82536|NCT02205658|"     The purpose of this study is to establish normative data for the Adult/Adolescent Sensory     History (ASH) and to determine if the ASH is able to discriminate between individuals aged     13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing     Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically     functioning.      It is anticipated that individuals with ASD will have the most problems with sensory     processing, those with SPD will also have problems in comparison to typical individuals. It     is also hypothesized that the measure will be able to discriminate between the three groups.   "
82537|NCT02205645|"     Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold   "
82538|NCT02205632|"     Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the     macular area.      Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be     evaluated by its optical density.      Reduced macular pigment level is a significant risk factor for age-macular degeneration. The     nutritional intake can minimise the risk of age-macular degeneration.   "
82539|NCT02205619|"     The purpose of this study was to evaluate the residual cementum with the histological     measurements and root surface topography with SEM evaluation using four periodontal treatment     methods.   "
82540|NCT02205606|"     The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with     primary hypercholesterolemia.   "
82541|NCT02205593|"     'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with     psoriasis or atopic dermatitis. A range of support activities will be offered in order to     learn effective self-management strategies and attitude to one's chronic skin disease and     consequently improving quality of life.   "
82542|NCT02205580|"     Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and     sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in     children. There are few reports about its use for postoperative analgesia by continuous     intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or     vomiting.      The investigators design this protocol to test efficacy of analgesia of three different rates     of continuous intravenous sufentanil infusion for postoperative pain management following     coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare     incidence rate of complications for three groups.   "
82543|NCT02205567|"     Bergamot-derived products have shown significant effects on plasma lipids. We aim in the     present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.   "
82544|NCT02205554|"     The purpose of this study is to compare the safety, pharmacokinetic properties (the     absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets),     Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.   "
82545|NCT02205541|"     The investigators aim to perform the first controlled randomized prospective study using ECZ     in pediatric STEC-HUS. This is of great interest as there is still no efficient specific     therapy in that potentially devastating disease.      Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial,     reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the     need for prospective studies.   "
82547|NCT02205515|"     Approximately 50% of patients with neuroendocrine cancers present with metastasis, a vast     majority to the liver. In such patients, one treatment option for liver-directed therapy is     surgical resection. However, a significant proportion of patients are not eligible for     resection because of patient factors (age, comorbidities) or tumor-related factors.      There have been scant data on the utility of EBRT (external-beam radiotherapy) and SABR     (stereotactic ablative radiotherapy) for metastatic neuroendocrine tumors of the liver. This     study will measure the effects of concurrent everolimus with external-beam radiotherapy to     the liver for metastatic neuroendocrine New methods of tumor assessment are needed in NETs.     Three new techniques are being developed at the Sunnybrook Research Institute to assess     tumour response to treatment: (1) contrast enhanced ultrasound; (2) perfusion CT; and (3)     perfusion MRI. These methods are devised to measure tumour perfusion and blood flow as     response indicators and can measure cell death non-invasively.        1. Concurrent everolimus given with external-beam radiotherapy to the liver for metastatic          neuroendocrine tumors of the liver will enhance the efficacy of radiotherapy and add          little, if any, toxicity        2. New radiological measures of CEUS and DCE-CT are effective measure to delineate tumor          response in NETs.   "
82548|NCT02205502|"     Ketamine seems an obvious choice in the setting of an emergency department in laceration     repair.      Lidocaine is the local anesthetics widespread used.      Ketamine leads to dissociative amnesia.      Theoretically , lidocaine is not useful in laceration repair using ketamine.      However, lidocaine is used with ketamine in many emergency department.      The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in     children undergoing primary closure   "
82549|NCT02205489|"     Primary Objective:      To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS     patients who will be medicated according to specified algorithm designed to manage infusion     associated reactions.   "
82550|NCT02205476|"     Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety     and long-term efficacy of PF-06473871 one year after surgical revision and treatment with     PF-06473871.   "
82551|NCT02205463|"     This dose-escalation study is to determine the safety, maximum tolerated dose (MTD) and     efficacy of KD019 in combination with trastuzumab and mFOLFOX-6.   "
82552|NCT02205450|"     The PWS is a genetic disease with intellectual disabilities associated with multiple     manifestations in other body systems. It is characterized by hypothalamic-pituitary     abnormalities with severe hypotonia during the early years of life, conditioning feeding     difficulties. Hyperphagia appears later, causing severe obesity in pre - school ages. Other     endocrine abnormalities associated produce short stature, GH deficiency and hypogonadotropic     hypogonadism. These patients also have varying cognitive dysfunction associated as well as     learning problems, compounded by the development of psychological-psychiatric and behavioral     problems language. The aetiology of GH decreased secretion of the SPW is controversial, it is     known that IGF -1 levels are reduced in children and adults with PWS. The rational use of GH     is derived from knowledge of comorbidities observed in PWS, which seem to be related to GH     deficiency: hypotonia, altered body composition, decreased growth, even obesity.      • The GH is accepted since 2000 for the treatment of PWS. Following fatal episodes in our     country, it was decided to start treatment at 2 years of age in an arbitrary manner, but not     in the U.S. or France. Subsequent studies have found that GH per se is not a risk factor for     mortality. The currently published data supporting the benefits of GH treatment when started     between 4 and 6 months of life, even some experts advocate starting at 3 months, but due to     the lack of consensus on the age of onset treatment, despite the benefits of your home at an     early age before the onset of obesity often starts around 2 years of life.      HYPOTHESIS The use of GH is safe and effective in patients with PWS children under 2 years     old.   "
82553|NCT02205437|"     Schizophrenia is a severe and chronic mental disorder. The lifetime risk of schizophrenia is     around 1%. Its course is chronic and frequently disabling. The keystone of schizophrenia     treatment is antipsychotic medications. The use of antipsychotics represents a huge public     health and economic burden to society. Most of antipsychotics drugs are metoo drugs,     directly or indirectly replicating dopamine D2 receptor blockade. Pharmaceutical companies     have aimed to produce drugs with a general indication for all patients with schizophrenia     with a one-size-fits-all strategy with no targeting or stratification. Second generation     antipsychotics partly improve positive symptoms and are quite often associated to weight     gain, metabolic changes and increased risk of cardiovascular diseases. Antipsychotics only     achieve a certain degree of clinical improvement in a percentage of patients (45%) and 30% of     the patients are treatment resistant. In light of the current deadlock, there is an urgent     need to expand the horizon of pharmacological research by elucidating new mechanisms related     to antipsychotic actions. An alternative strategy is the comparison of gene expression     profiles in drug-naive accurately ill patients before and after antipsychotic treatment has     been initiated. Our research group has a great experience in the field and has been working     on this hypothesis in the latest years. We propose a continuation project to thoroughly     explore the clinical implications (clinical response to antipsychotic drugs or emergence of     metabolic side effects) of the variants in gene expression we have recently described in     schizophrenia patients. This project takes advantage of an exceptional (regarding to the     detailed knowledge of clinical outcome and side effect profile) longitudinal cohort of     drug-naive patients with schizophrenia who had been followed up for three years at the     University Hospital Marqués de Valdecilla.   "
82554|NCT02205424|"     Stroke and dementia are two of the most common and disabling conditions worldwide,     responsible for an enormous and growing burden of disease. There is increasing awareness that     the two conditions are linked, with cognitive impairment and dementia common after stroke,     vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on     the contribution of vascular risk factors to Alzheimer's disease. Yet we still know very     little about whether brain volume loss - a hallmark of dementia - occurs after stroke, and     whether such atrophy is related to cognitive decline. The aim of this research is to     establish whether stroke patients have reductions in brain volume in the first three years     post-stroke compared to control subjects, and whether regional and global brain volume change     is associated with post-stroke dementia in order to elucidate potential causal mechanisms     (including genetic markers, amyloid deposition and vascular risk factors). We hypothesise     that stroke patients will exhibit greater brain volume loss than comparable cohorts of     stroke-free controls, and further, that stroke patients who develop dementia will exhibit     greater global and regional brain volume loss than those who do not dement. An understanding     of whether stroke is neurodegenerative, and in which patients, may be used to help guide the     early delivery of disease-modifying therapies.   "
82555|NCT02205411|"     The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart     HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death     from refractory end-stage heart failure.   "
82557|NCT02205385|"     Subjects are being asked to participate in this study because they have an arm or leg     amputation and have developed pain related to a neuroma (an ongoing localized pain related to     a cut nerve ending).      We are studying two different types of surgery to treat the neuroma pain. Today there are     many surgical options reported which often means that there is no one best treatment. The     surgery that shows the best success so far, involves cutting out the scarred nerve ending     (neuroma) and burying the freshly cut nerve ending in a nearby muscle. Recently, a new     surgery has been developed called targeted reinnervation (TR). This surgery connects these     cut nerve endings to nerves going into nearby nonfunctional muscles. This surgery was     developed to allow amputees to have better prosthesis control. By chance, neuroma pain     improved significantly with TR. We, therefore, are conducting this clinical trial to evaluate     which of these two surgeries best treats neuroma pain. We will ask all participants to fill     out a questionnaire both before and after surgery. This will help us understand how a neuroma     affects the quality of life of amputees and will allow us to understand which surgery leads     to the best improvement in neuroma pain.      In order to confirm the presence and location of the neuroma before surgery, a magnetic     resonance image (MRI) will be performed. Taking these pictures requires subjects to lie still     for a short period of time but does not involve any invasive procedures. After surgery, the     MRI will be done again, this time to see if the nerve shows signs of scarring.   "
82558|NCT02205372|"     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995     in Subjects with Diabetic Nephropathy.   "
82559|NCT02205359|"     The purpose of this clinical study is to test the hypothesis that market released Cardiac     Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a     superior outcome compared to standard CRT devices in CRT indicated patients with normal     atrio-ventricular (AV) conduction and left bundle branch block (LBBB).   "
82560|NCT02205346|"     Investigate urinary leukotriene E4 levels and determine if there is a correlation with     severity of obstructive sleep apnea. The investigators then would like to determine a     threshold level which could then be used for confirmation of diagnosis of obstructive sleep     apnea (OSA).   "
82561|NCT02205333|"     The main purpose of this study is to determine the best dose of MEDI6469 that is safe and     tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736     (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large     B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469     in a set of participants with advanced solid tumors while rituximab will be tested with     MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants     with advanced solid tumors.   "
82562|NCT02205320|"     This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers     with three forms of pegylated granulocyte colony stimulating factors.   "
82563|NCT02205307|"     This is a randomized, controlled, parallel, multicenter study to determine the difference in     post-operative anastomotic leak rate in low anterior resection procedures where colon and     rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical     practice compared to surgical procedures performed according to standard surgical practice     alone.   "
82564|NCT02205294|"     Osteopathic treatment will provide:        1. A significant reduction of pain and swelling of the affected DVT leg        2. An increase in the quality of life (QOL) for individuals with DVT of the leg        3. Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg   "
82565|NCT02205281|"     The purpose of this pilot study is to test the feasibility of an innovative, couples based     approach to weight management during pregnancy. The primary hypothesis is that a     couples-based behavioral weight management program will reduce the rate of gestational weight     gain compared to standard care.   "
82566|NCT02205268|"     Background Attention Deficit Hyperactivity Disorder (ADHD) is one of the most frequently     diagnosed behavioural disorders in childhood that requires treatment(3-5% of children). It is     an important health problem because it impairs social, educational and occupational     performance, and increases the risk of other psychiatric disorders including anxiety,     depression and substance misuse. There is no cure for ADHD and standard stimulant medication     treatment is at best symptomatic. Moreover, stimulants have side effects and parents are     often concerned over the long-term effects. A number of non-drug treatments have been     developed but these do not target the brain directly. Neurofeedback Training (NTx) is a new,     non-drug treatment that targets the brain directly and that can potentially enhance the     control of attention in ADHD. NTx could be a valuable alternative and/or adjunct to standard     care.      Aims Although NTx has gained popularity in Europe and the US, more rigorous studies are     required to support its implementation in the NHS. We therefore propose a pilot study to     establish tolerabilty and safety, and to develop treatment protocols and collect data to     design a follow-on controlled NTx trial in ADHD.      Methods We plan an open label, single arm, treatment trial of near infrared spectroscopy     neurofeedback training of frontal lobe activation in school-aged children with ADHD. 48     participants will be recruited over 1 year and will be offered 20 NTx sessions over 10 weeks.     Participants will be recruited from Mental Health Services. Primary outcomes will be safety     and tolerability and secondary outcomes will include standard clinical behavioural rating     scales and the Test Of the Variables of Attention.   "
82567|NCT02205255|"     A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.   "
82568|NCT02205242|"     A first sub-analysis of the BACE trial will address physical activity levels in a subgroup of     the intervention study with portable validated activity monitors.   "
82569|NCT02205229|"     Single center, prospective, observational study to assess serum concentration of ingredients     used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.   "
82571|NCT02205203|"     This research study aims to test the feasibility and effectiveness of using the Mayo Clinic     Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of     anxiety disorders in youth, particularly those youth who may have limited access to mental     health treatment in the traditional clinical setting.   "
82572|NCT02205190|"     A phase I clinical trial to compare the pharmacokinetics and safety of     fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and     rosuvastatin in healthy male volunteers   "
82573|NCT02205177|"     This research study aims to test the feasibility and effectiveness of using the Mayo Clinic     Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of     anxiety disorders in youth, particularly those youth who may have limited access to mental     health treatment in the traditional clinical setting.   "
82574|NCT02205164|"     The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of     palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in     preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.   "
82575|NCT02205151|"     An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics     of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine     as Individual Tablets in Healthy Male Volunteers   "
82576|NCT02205138|"     Among existing surgical techniques, spinal fusion is considered as the gold standard to treat     a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis,     with regard to pain reduction and functional improvement. However, pseudarthrosis and failure     to relieve low back pain are unfortunately still frequent, irrespective of the type of     procedures and grafts used by the surgeon.      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a     proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.   "
82577|NCT02205125|"     Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional     method for removal however the snared area after removal can occasionally appear uneven     raising the possibility that complete removal has not occurred. The significance of this     irregularity has not be studied. This study aims to separately sample the irregular area and     determine the constituents while recording how frequently this occurs during routine     colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue     and do not represent polyp tissue left behind.   "
82578|NCT02205112|"     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of     intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with     community-acquired pneumonia (CAP).   "
82579|NCT02205099|"     This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible     dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable     schizophrenia.   "
82580|NCT02205086|"     This study compares the ability of clinicians to make diagnoses with or without the     assistance of diagnostic decision support software. The area of clinical focus is primarily     rheumatology.   "
82581|NCT02205073|"     This is a single site, randomized, double-blind, three period cross-over, placebo-controlled,     proof of mechanism study in healthy male subjects. The study will investigate whether the     directionality of brain activity and connectivity in response to intranasal vasopressin     treatment is similar to earlier studies and explores the effect of short-term treatment with     RG7314 on functional MRI as a pharmacodynamic marker. While in the scanner, the participants     will be asked to perform a face matching task and a Theory of Mind task, among other     assessments. Participants' exposure to study drug will be assessed and all participants will     receive follow-up examination 1 and 4 weeks after last dose.   "
82582|NCT02205060|"     The therapeutic efficacy of virtual reality has been validated for the treatment of various     mental disorders ,smoking behavior is the first preventable cause of death in developed     countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has     been observed, which emphasize the urgent need to implement new strategies. Virtual reality     cue exposure for the relapse of tobacco consumption   "
82583|NCT02205047|"     The purpose of this study is to find out whether either trastuzumab or the combination of     trastuzumab and pertuzumab with standard chemotherapy shows more activity against     gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery     and it can be safely administered.   "
82584|NCT02205034|"     The Prader-Willi syndrome (PWS) includes severe neonatal hypotonia with impaired suckling     leading to failure to thrive in the most severe cases, subsequently followed by an early     onset of morbid obesity with hyperphagia and deficit of satiety, combined with other     endocrine dysfunction probably due to hypothalamic dysfunction. The pathophysiological     mechanism of the occurrence of the 2 main nutritional phases of PWS is unknown. Swaab     reported a deficit in the oxytocin (OT)-producing neurons of the paraventricular nucleus in     the brain of these patients. In addition of its well-known anorexigenic effect, OT is     involved in establishing and maintaining social codes. Moreover in a PWS mouse model     generated from a MAGEL2 KO gene a single OT injection at 5 hr of life prevent the early death     observed in 50 % of the new born mice by recovering normal suckling. Interestingly this     effect is no longer observed if OT injection takes place later. Our hypothesis is that early     administration of OT in babies with PWS may improve suckling and possibly infant-mother     interactions. In our recent study (manuscript in preparation), we have shown that a single     intranasal administration of OT is well tolerated. This escalating dose study is designed to     evaluate the tolerance of repeated intranasal administration of OT in 3 steps (4IU every     other day, 4 IU daily, 4IU twice daily) in babies younger than 5 months with PWS.   "
82585|NCT02205021|"     Accumulation of fat in the neck using tape measures has been linked to increased     cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat     using computed tomography will show that specific fat compartments in the neck contribute     differently to cardiovascular risk.   "
82586|NCT02205008|"     Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate     intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although     we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal     chemotherapy have been published.      In this study, we review the clinicopathological characteristics of patients and effects of     early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric     cancer-specific survival and patterns of recurrence of gastric cancer patients with     macroscopic serosal invasion.      The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall     and disease free survival of advanced gastric cancer patients with serosal invasion after     potentially curative surgery.   "
83044|NCT02199015|"     The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS)     causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing     spasticity and the spastic syndrome in selected cases of patients with cerebral palsy   "
82587|NCT02204995|"     Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in     postmenopausal women. Many surgical treatments have been described and recent literature has     show that the relatively simple trapeziectomy gives equal results and less complications,     when compared to other techniques such as ligament reconstructions and interpositions. These     studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage     4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases     the chance for collapse of the first metacarpal bone and associated problems.      The investigators' hypothesis is that an LRTI can be of additional value in patients with     stage 4 osteoarthritis.   "
82588|NCT02204982|"     A study to evaluate the safety and efficacy of IPI 145 administered in combination with     rituximab vs placebo in combination with rituximab in patients with previously treated     CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.   "
82589|NCT02204969|"     The thermal therapy combined with magnetic fields and ozone has a direct effect on patients     with dementia and Alzheimer's with a regression of more than 60% of them   "
82590|NCT02204956|"     Smoking rates among individuals with psychiatric disorders are disproportionately higher than     the general population. The majority of psychiatric hospitals ban smoking on hospital     grounds, thus providing an opportunity for inpatients to experience abstinence. Yet smokers     in inpatient psychiatric settings are infrequently provided with referrals for cessation     treatment on discharge (< 1 %) and most resume smoking upon discharge. Therefore, the     integration of effective cessation interventions within the current mental health treatment     system is a public health priority.      The overall objective of this project is to adapt an Extended Care (ExC) model to smokers     with severe mental illness (SMI) engaged in a psychiatric hospitalization and to conduct a     randomized, pragmatic effectiveness trial designed to assess the benefit of this adapted ExC     in real-world practice. We will test the hypothesis that, among smokers with SMI in inpatient     psychiatric treatment (n = 422), ExC will result in significantly greater rates of     cotinine-validated, 7-day point prevalence abstinence at 6- and 12-months compared to a group     that receives Brief Education (BE) about smoking cessation. Furthermore, we hypothesize that     a higher proportion of ExC vs. BE patients will use evidence-based smoking cessation     treatment (counseling and pharmacotherapy) in the month after discharge. We will also explore     the effect of ExC on health and health care utilization in the 12 months post-discharge     (psychiatric symptoms, psychiatric and medical hospital readmissions and emergency room     visits) and the effectiveness of ExC on smoking abstinence in patient diagnostic subgroups.      The expected outcome of this project is a demonstration of the effectiveness of an Extended     Care intervention for smoking cessation in individuals with severe mental illness (SMI)     following psychiatric hospitalization. Future studies could extend these findings to     individuals with SMI receiving outpatient psychiatric treatment or psychotherapy. Overall,     this research would have a significant positive public health impact that will move us closer     to the long-term goal of dissemination and integration of the Extended Care model to increase     smoking cessation and decrease smoking related morbidity and mortality in people with severe     mental illness.   "
82591|NCT02204943|"     This study will examine biomarkers involved in osteomimicry in bone metastases and     circulating tumor cells (CTCs) of men with mCRPC before and during therapy with the     bone-targeting radiopharmaceutical radium-223. This study will also examine the     bio-distribution of radium-223 in bone and bone metastases of men with mCRPC.      The investigators hypothesize that bone metastases and CTCs in men with mCRPC will commonly     express markers of EMT/plasticity and osteomimicry, not just in the normal surrounding     osteoblastic stroma but in the epithelial tumor cells themselves and that radium-223 will     target both of these compartments including the more mesenchymal/osteoblastic tumor cells and     the surrounding osteoblasts in the active bone microenvironment, with a relative sparing of     normal bone and bone marrow.   "
82592|NCT02204930|"     The purpose of this First in Man study is to evaluate the safety and tolerability, as well as     to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in     patients undergoing open liver resection surgery.   "
82593|NCT02204917|"     In this clinical trial the investigators aim to evaluate the diagnostic feasibility and     safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and     urethral imaging in children.   "
82594|NCT02204904|"     Study ALD 103 is a multi-site, global, data collection study that is designed to evaluate     safety and efficacy of allogenic hematopoietic stem cell transplantation (allo-HSCT) in     patients with CALD aged 17 or younger.   "
82595|NCT02204891|"     The aim of the present study is to demonstrate the effect of a mixture of four species of     probiotics (Saccharomyces boulardii, Bifidobacterium lactis BB-12, Lactobacillus acidophilus     LA-5 and Lactobacillus plantarum) in patients with symptomatic irritable bowel syndrome (IBS)     who have culture verified syndrome of intestinal bacterial overgrowth (SIBO) and those who do     not have. This will provide direct evidence for the role of probiotics in treating part of     the pathogenesis of IBS.   "
82596|NCT02204878|"     To searching the role of parecoxib sodium for postoperative pain management in open     hepatectomy   "
82597|NCT02204865|"     Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing     for periods whilst asleep, is common in heart failure and associated with a poor prognosis.     This study aims to validate a novel function available on certain pacemakers which is     designed to detect this condition.The investigators hypothesize that ApneaScan can accurately     detect moderate to severe sleep disordered breathing in patients with heart failure as     compared against an Embletta sleep study. The investigators will also follow up our patients     for 2 years to determine whether the severity of sleep disordered breathing as assessed by     ApneaScan correlates with prognosis.   "
82598|NCT02204852|"     Objective Evaluating the safety and efficacy of iloprost and eptifibatide co-administration     compared to placebo as an addition to standard care in septic shock patients.      Trial rationale Iloprost and eptifibatide combination therapy in septic shock patients is     expected to deactivate the endothelium and restore vascular integrity, reduce formation of     microvascular thrombosis and dissolve existing clots in the microcirculation and maintain     platelet counts, thereby improving platelet-mediated immune function and reducing the risk of     bleeding. Together this is expected to translate into reduced organ failure and improved     outcome in patients with septic shock.      Trial population The trial population is patients >18 years admitted to the ICU with septic     shock within the last 24h. Eighteen evaluable septic shock patients will be included.      Trial design This is a single center, randomized (2:1, active:placebo), placebo controlled,     double-blind investigator-initiated phase IIa trial in patients with septic shock,     investigating the safety and efficacy of co-administration of Iloprost and Eptifibatide as a     48h continuous i.v infusion in totally 18 patients.      All patients will receive standard ICU care including LMWH thrombosis prophylaxis.      As all patients present at the trial site in an acute, critical condition, scientific     guardians will co-sign the informed consent form before inclusion. Next-of-kin and the     patients' general practitioner will co-sign as soon as possible and the patient will provide     informed consent whenever possible. The active treatment is expected to improve the clinical     condition of the individual patient and to provide information that may translate into     improved therapy of future sepsis patients.      During the study, blood samples will be taken at different time points. Patients will be     observed and assessed continuously with regards to complications including bleeding. Patients     will be actively assessed as long as the patient is in the ICU. During the extended follow up     period at day 30 and 90, contact will be made with the patients to follow up on safety events     and vital status.      The trial is conducted in accordance with the protocol and the current regulatory     requirements and legislation in Denmark.      Investigational product The active treatment in the trial comprises co-administration of 1     ng/kg/min Ilomedin® and 0.5 µg/kg/min Integrilin® as 48h continuous i.v infusions. The drugs     will be purchased and administered according to the product specifications.      Placebo The placebo in the trial is 0.9% saline as 48h continuous i.v infusion, which will be     used as placebo for both study drugs. The i.v volume of placebo saline to be administered is     equal to the administered volume of diluted (in 0.9% saline) active drug.      Data protection In compliance with the Danish data protection law, the trial will be approved     by the Danish Data Protection Agency.      Sponsor of study and financial support This research project is investigator-initiated by the     trial sponsor and co-investigator Sisse R. Ostrowski and co-investigator Pär I. Johansson in     collaboration with the principal investigator Morten Bestle.      It has not received funding from any commercial sponsors.      Time line Patient recruitment period runs from September 2014 to August 2015. Follow-up data     on 30-day and 90-day outcome and adverse events will be collected. Initial data analyses will     be done after completion of 30-day follow-up for all patients. Secondary data analyses will     be done after completion of 90-day follow-up for all patients.   "
82599|NCT02204839|"     The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus,     Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate     feeding and rapid-acting insulin dose recommendations will protect patients with type 1     diabetes from early- and late-onset hypoglycaemia following evening time exercise.   "
82632|NCT02204410|"     This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids     for deficient emotional self-regulation (DESR) as a supplement to Attention     Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention     Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently     be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR     traits.   "
82633|NCT02204397|"     A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of     INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in     patients with established T1DM.   "
82634|NCT02204384|"     To compare the acute effect of soluble fiber intake from foods or supplement after a common     meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The     hypothesis is a meal with a high content of soluble fiber from food determines glycemic and     insulinemic response similar to a meal with a high content of soluble fiber from supplement     sources.   "
82600|NCT02204826|"     Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting     herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate     its therapeutic characteristics. KRG has been shown to be effective in many diseases, such as     cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency syndrome,     and sexual dysfunction. Several studies have indicated effects of ginseng on improving     spermatogenesis in animals. The major mechanisms behind these effects were speculated to be     anti-oxidant and anti-aging effects, as well as modulation of the     hypothalamus-pituitary-testis axis [7 - 10]. However, there have been no controlled human     clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male     infertility.      Only a small proportion of causes of male infertility are currently curable, including male     hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia     that can be corrected by surgery. In addition, evidence-based medicine has revealed that most     empirical treatments are ineffective. Similarly, the efficacies of carnitine, anti-estrogens,     kallikrein, vitamins C and E, and glutathione have not been confirmed.      Therefore, the investigators investigated the effects of KRG on semen parameters in male     infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic     effects of KRG in male patients.   "
82601|NCT02204813|"     There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y     gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part     to an intestinal hormone, called GLP-1, that is released into the circulation immediately     after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial     effects of RYGB surgery on glucose homeostasis in humans.   "
82602|NCT02204800|"     Active surveillance in kidney cancer involves closely observing the tumor with periodic     imaging studies rather than immediately proceeding to an invasive treatment. This does not     mean that the tumor is ignored or that future treatment is not necessary, rather it means the     tumor does not require treatment at this time. On active surveillance, a tumor is closely     monitored without treatment, however if the tumor changes and reaches a predefined threshold     that your physician no longer considers safe, your physician will strongly encourage     treatment.   "
82603|NCT02204787|"     The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique,     tDCS (transcranial direct current stimulation) used as a complementary treatment on negative     symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will     be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include     neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social     functioning.   "
82604|NCT02204774|"     The objective of this prospective cohort study in patients with a known thoracic aortic     aneurysm is to test the hypothesis that yearly aneurysm progression rate is higher in     patients with obstructive sleep apnoea (OSA) compared to patients without OSA, and that the     need for aortic operation or proven or presumed death from aortic rupture or dissection     happens more often in patients with thoracic aortic aneurysm and OSA compared to patients     without OSA.   "
82605|NCT02204761|"     This pilot clinical trial studies proton beam radiation therapy in treating patients with     thoracic cancer that has come back and have received prior radiation therapy. Proton beam     radiation therapy uses high energy protons to kill tumor cells and may cause less damage to     normal tissue.   "
82606|NCT02204748|"     A better understanding of knee joint kinematics is important to explain the premature     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a     prosthesis that most closely approximates the normal knee. Specifically, posterior     stabilizing (PS) knees have been found to be associated with lower amounts of posterior     femoral rollback, higher occurrence of reverse axial rotation and increased amount of     condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee     system has incorporated subtle changes in its design to address restoration of kinematics     that more closely resemble those of a normal knee. To understand if this design is able to     effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.     This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively     using the University of Tennessee's mobile fluoroscopy unit while performing three daily     activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there     is no hypothesis.   "
82607|NCT02204735|"     While eating the majority of energy earlier in the day appears to have a positive effect on     weight and cardiometabolic outcomes, it is not clear how eating earlier in the day influences     other behaviors that have a circadian rhythm (sleep), other energy balance behaviors     important for weight loss (physical activity), and self-reported feelings of appetite control     (hunger and fullness). Thus the purpose of this study is to examine the influence of timing     of eating on sleep patterns, physical activity, and self-reported feelings of appetite     control. It is hypothesized that those who eat the majority of their calories earlier in the     day will have greater weight loss than those who eat the majority later in the day.   "
82608|NCT02204722|"     This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all     patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic     phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level     after three month dosing and be maintained their dose of 400mg/day. On the other hand, the     group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day.     The superiority of the group B will be proved by evaluating the MMR rate of these two groups     after 12 months of administeration of Imatinib.   "
82609|NCT02204709|"     The purpose of this study is to determine how eating fish raised to have different levels of     omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated     cardiovascular risk.   "
82610|NCT02204696|"     The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive     sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with     normal soft palate and uvula length.   "
82611|NCT02204683|"     The main goal is to study way that aflibercept injection behaves in the eye and in the body     of patients with wet macular degeneration, in patients who have had previous vitreous removal     surgery.   "
85079|NCT02172404|"     Trial to compare the administration technique for HandiHaler® vs. MDI, to compare the     learning retention of the administration technique for the HandiHaler® vs. MDI and to compare     the ease of use for HandiHaler® vs. MDI   "
82612|NCT02204670|"     Background :      Regular exercise is a cornerstone in the prevention and the management of comorbidities.     Unfortunately, the metabolic benefit of exercise training is not universal and varies among     individuals. A main factor likely to explain the exercise training variability is the lack of     empirical evidence on the determinants of exercise training. A series of muscle-derived     cytokines have recently been discovered that (1) are released during exercise and (2) exert     positive effects on peripheral tissues. Irisin is one of these novel myokines and might     contributes to the metabolic adaptations to exercise training.      Methods:      The investigators will perform a pilot cohort study in which obese adolescents will perform     resistance exercise training for 6 weeks. The main exposure variable will be the acute     release of irisin during resistance exercise. The main outcome measures will be the change in     hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral     glucose tolerance test.      Study Hypothesis:      The primary overall hypothesis is that the change in plasma Irisin with a single bout of     exercise will be associated with the metabolic adaptations to 6 weeks of resistance training,     specifically, the reductions in hepatic triglyceride content and post-prandial glucose     excursions, in obese adolescents.   "
82613|NCT02204657|"     The purpose of this study is to determine if professional Continuous glucose monitoring     improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes     Mellitus   "
82614|NCT02204644|"     A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line     treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.      Randomized,Open Label,Control   "
82615|NCT02204631|"     The goal of this study is to assess the experience of our patients with head and neck cancer     in regard to the information they receive, their symptoms, and their understanding of their     diagnosis, to determine ways to improve upon these aspects of patient care in the future.   "
82616|NCT02204618|"     The investigators assume that cochlear implants in this indication are not only effective but     also cost-effective. The investigators' experimental protocol relies on real life therapeutic     strategy, where a cochlear implant may be proposed once CROS and bone conductions systems     have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction     devices. If these trials are ineffective, the remaining subjects will be randomized between     two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A     comparative cost-utility analysis between the two arms, of medical consequences measured in     terms of quality of life will identify a preference for a strategy. Specific binaural hearing     measurements with respect to each treatment option (abstention, CROS, bone conduction device,     cochlear implant) will also be collected.   "
82617|NCT02204605|"     The investigators would like to determine if there is a difference in patient satisfaction     among patients who have puzzling pain conditions and receive one evaluation from their     treating physician, and those that receive an evaluation from their treating physician and     from a group of consulting physicians by video. The investigators expect to enroll 128     patients at Massachusetts General Hospital.   "
82618|NCT02204592|"     The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article     entitled Staff Burnout in which he discussed job dissatisfaction precipitated by     work-related stress. A broadly applicable description defines burnout as a state of mental     and physical exhaustion related to work or care giving activities. A long-standing conceptual     and operational definition characterized burnout as a triad of emotional exhaustion     (emotional over extension and exhaustion), depersonalization (negative, callous, and detached     responses to others), and reduced personal accomplishment (feelings of competence and     achievement in one's work) In the World Health Organization International Classification of     Diseases, 10th revision, burnout is defined as a state of vital exhaustion. Although no     specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental     Disorders, burnout is a clear syndrome with significant consequences.      Burnout in health care professionals has gained significant attention over the last several     years. Given the intense emotional demands of the work environment, clinicians are     particularly susceptible to developing burnout above and beyond usual workplace stress.     Residency training, in particular, can cause a significant degree of burnout, leading to     interference with individuals' ability to establish rapport, sort through diagnostic     dilemmas, and work though complex treatment decision making. Overall, burnout is associated     with a variety of negative consequences including depression, risk of medical errors, and     negative effects on patient safety. The goal of this review is to provide medical educators     and leaders with an overview of the existing factors that contribute to burnout, the impact     of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.   "
82619|NCT02204579|"     This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor     antagonist) on activating mutations of the Calcium-sensing receptor in patients with     Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an     inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and     hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV     infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary     depending on measured levels of ionized calcium.   "
82620|NCT02204566|"     12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio     frequency (RF) ablation will be asked to swallow the capsule.      As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation     caused any form of damage to the esophagus considering it being so close to the heart.      After the capsule has been removed from the mouth, they will be asked about the tolerability     of the capsule.   "
82635|NCT02204371|"     This study will investigate whether pazopanib can reduce epistaxis and improve anaemia in     subjects with hereditary haemorrhagic telangiectasia (HHT) at a dose that is well tolerated.     The study will have 2 parts. Part A will be an open label, dose-escalation study in which up     to 4 cohorts of approximately 6 subjects each will receive increasing doses of pazopanib for     a maximum of 12 weeks. The dose in the first cohort will be 50mg per day and the maximum dose     in a cohort will be 400 mg per day. Dose escalation will not occur as planned if the     predefined safety stopping criteria are met or at least 4 subjects in a cohort have     demonstrated efficacy (as measured by epistaxis, haemoglobin, transfusion or iron infusion     requirements). If efficacy is demonstrated in Part A with an acceptable safety profile, Part     B will be initiated to further define the optimal dose(s) including dose duration/schedule     and to provide further support for the proof of mechanism. Approximately 15 subjects will     participate and will be randomised to active or placebo in a ratio of 3:2. This part of the     study will be double-blind.   "
82636|NCT02204358|"     Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial     dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide     clinical evidence for the treatment of uterine infertility   "
82621|NCT02204553|"     This will be a multi-center, open label, expanded treatment protocol of panobinostat,     bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.     Panobinostat will be administered at a starting dose of 20mg orally three times a week (every     other day) for two weeks on and one week off, with dose adjustments permitted based on     observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously,     twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients     who have achieved stable disease or better by modified EBMT 1998 criteria may continue     combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up     to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable     disease or better may continue on therapy at the discretion of their investigator until     September 2015 or until drug is commercially available, whichever comes first. Patients who     have not achieved at least stable disease by 8 cycles must discontinue from study treatment.     Dexamethasone will be administered on the day of and the day immediately following bortezomib     treatment. Patients will not receive any study treatment during the third week of each cycle.     Cycles will be defined as 21 days of treatment. Investigators may not add any other     anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study     treatment. Patients will remain on study until disease progression, unacceptable toxicity, or     end of the study   "
82622|NCT02204540|"     This study tests the feasibility of having study participants use webcams to participate in     research studies. The study scientists hypothesize (1) that webcams will be an adequate     method of detecting a participant's ability to perform a tasks for a clinical trial (e.g.,     swallowing a pill, eating food) and (2) that a majority of study participants would be     willing to use a webcam to participate in a research study.   "
82623|NCT02204527|"     In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown     to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D     supplementation in patients with type 2 diabetes and hypertension   "
82624|NCT02204514|"     The purpose of this study is to assess the pain-relieving effects of surgery for painful     external snapping hip.   "
82625|NCT02204501|"     The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of     528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of     midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK     profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as     the safety of vapendavir will also be assessed.   "
82626|NCT02204488|"     Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in     postmenopausal women. Many surgical treatments have been described and recent literature has     show that the relatively simple trapeziectomy gives equal results and less complications,     when compared to other techniques such as ligament reconstructions and interpositions. A     relatively new treatment modality, which has been further developed in recent years is the     total joint arthroplasty. Randomized prospective trials and long-term results are lacking,     but prospective cohorts show a faster recovery and good results after one year, without an     increase in complication rate.      We hypothesize that a total joint arthroplasty gives a better objective and subjective result     after one year than a trapeziectomy.   "
82627|NCT02204475|"     This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir     (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and     Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C     virus (HCV)-infected participants. The primary hypothesis is that the proportion of     treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir     + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA])     12 weeks after the end of study therapy (SVR12) will be greater than the proportion of     BOC/PR-treated participants achieving SVR12.   "
82628|NCT02204462|"     Our preclinical studies suggest the capacity of the positron emission tomography imaging     agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast     tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy     than that obtained by existing breast imaging tools.   "
82629|NCT02204449|"     The current study is a randomized controlled trial, being conducted at two hospitals in     Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an     intervention group, in which they will receive mentorship from a volunteer cardiac     rehabilitation peer mentor, and a control group, in which they will receive usual care.     Patients in both groups will be tracked to determine if they are referred to cardiac     rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to     cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac     rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac     rehabilitation.   "
82630|NCT02204436|"     Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a     cosmetic treatment for spotted hand skin; in particular it was investigated the synergic     activity of an emulsion, with clarifying-antioxidant activity combined with an activator gel,     with hydration and keratolytic activity.      Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were     included in the study.      It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by     the volunteers and tolerance both by investigator and volunteers.   "
82631|NCT02204423|"     Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold     standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI),     where most benefits of the radial approach, such as reduced major bleeding and mortality, can     be expected. However there is very limited research available looking at the consequences of     trans-radial access for upper extremity function.      The main objective of this study is to provide insight in the morbidity with regards to the     upper extremity surrounding the radial access route in percutaneous coronary interventions.     Secondary objectives are to provide insight in the consequences for functional status,     factors influencing and financial costs of this morbidity, to identify subject who might     benefit from early referral and treatment of this morbidity and to generate hypotheses for     further clinical research into this matter.      The investigators hypothesis is that approximately 20% of the population will experience     upper extremity dysfunction after TR-PCI.   "
82639|NCT02204319|"     The objectives of this pilot study are to demonstrate effectiveness of application of the     Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk     low level laser red diode light therapy device, in providing relief of pain symptoms in     patients with provoked and non- provoked vulvar vestibulitis; to reduce the frequency of use     of oral medications to manage pain symptoms; and to reduce the debilitating affect vulvar     vestibulitis has on the patient's daily activities, relationships and emotional well-being.   "
82640|NCT02204306|"     In gastric cancer patients treated with 5-FU and cisplatin, higher tumor TS levels were     associated with a less favorable response (29% vs. 68%; p=0.024). Similarly, in a study in     which patients were treated with high dose 5-FU, patients with high TS expression had a     response rate of only 12.5%. Conversely a response rate of 92.9% was observed in patients     with low tumor TS expression. A longer but not statistically significant survival advantage     was observed in patients with the TSER*2 allele compared with the TSER*3/*3 patients.     Additionally, a review by Patel et al. identified approximately 20 gastric cancer studies     that have found a positive association between TSER genotype and clinical response (in either     direction). Therefore, the primary goal of this proposal is to prospectively genotype     patients, select patients with good risk TSER genotypes (TSER*2*/*2 or *2/*3) and treat     them with a standard 5-FU containing regimen (FOLFOX) in order to improve clinical outcomes,     while randomize patients with the poor risk TSER genotype (*3/*3) to either the standard     5-FU containing regimen or another non-5-FU-based regimen (docetaxel/cisplatin).   "
82641|NCT02204293|"     Interleukin-1 antagonists such as canakinumab have been used for the treatment of AOSD and     have had a marked influence on the activity of the disease, including joint mobility. Results     from controlled clinical studies are not, however, currently available.   "
82642|NCT02204280|"     Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In     most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in     the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in     type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria     will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less     value as a marker in DM because it has a variety of causes, including hypertension. Thus,     additional markers are needed to identify patient groups with a high risk of developing overt     diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to     identify its significance in the diagnosis of diabetic nephropathy.   "
82643|NCT02204267|"     Investigator-initiated prospective randomized multicentre study to uncover the true burden of     paroxysmal atrial fibrillation in a representative population of acute stroke patients     without known atrial fibrillation.   "
82644|NCT02204254|"     Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like     flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments     include topical (metronidazole) and systemic (doxycycline) antibiotics with only a suspensive     effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a device     emitting an electromagnetic current inducing an increase in temperature when applied on the     skin, potentiated by infrared light. The monopolar RF has already been used in rosacea on a     small number of cases with positive and prolonged results. RF with Elos system has been     evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex folliculorum     (DF) is a long transparent mite which asymptomatically parasitizes pilosebaceous follicle of     normal human skin sometimes responsible of inflammatory facial dermatoses. The prevalence and     density of DF are increased in rosacea, and DF is suspected to play a role in the     pathogenesis of rosacea. DF is sensitive to heat, and the investigators hypothesize that     radiofrequency treatment may affect the survival of the mite and should be effective to treat     papulopustular rosacea.   "
82645|NCT02204241|"     This protocol is a phase I/II multicenter study designed to assess the safety and the     efficacy of the proposed combinations as up-front treatment in elderly Multiple Myeloma (MM)     patients.   "
82646|NCT02204228|"     The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder     construct. When used under the conditions and purposes intended the TRS will relieve pain and     restore some functional joint motion to the affected shoulder. The purpose of this study is     to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.   "
82647|NCT02204215|"     Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery.     The purpose of this study is to determine whether electric acupuncture therapy is effective     in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with     sepsis or multiorgan system failure.   "
82648|NCT02204202|"     The purpose of this research study is to gain understanding of the basic responses of the     lungs to inflammation and specifically if there may be a better way to detect graft     inflammation using non-invasive methods as well as to determine the effectiveness of     immunosuppressive treatment regimens in preventing acute rejection in lung transplant     recipients.   "
82649|NCT02204189|"     The purpose of this study is to determine whether TongFuSan is effective in the treatment of     acute pancreatitis with gastrointestinal dysfunction.   "
82662|NCT02204020|"     Despite improvements in outcomes after Hematopoietic Cell Transplantation (HCT) for Acute     Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), the risk of relapse remains high     and is the most common cause of mortality after HCT. Moreover, treatment options for relapse     after HCT are limited. Strategies to reduce relapse with maintenance therapy in patients who     are at high risk are needed to improve survival. 5-aza is a hypomethylating agent that has     shown immune modulating properties that may enhance the graft-versus-leukemia (GVL) effect,     including upregulation of tumor-associated antigen and costimulatory molecule expression.     Moreover, 5-aza has properties that suggest protection against graft-versus-host disease     (GVHD) as well. Preliminary data shows that it is well tolerated and effective in clinical     use for the treatment of AML or MDS relapse after HCT, as well as for maintenance therapy.     This study will evaluate the use of 5-aza for maintenance after HCT in patients with AML or     MDS with risk factors that are associated with a high risk for relapse.   "
83167|NCT02197403|"     1. Adequate sedation with classical sedative agents, propofol        2. Sedation with propofol may induce paradoxical excitement response in heavy alcohol          drinkers        3. Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol          drinkers   "
82650|NCT02204176|"     The rate of adult obesity in the United States has increased more than two times since 1970,     and the rate of child-teen obesity has increased by four times. One of the antecedents of     obesity is an inactive lifestyle. Exercise has been known to be associated with increases in     both physical and mental health by increasing longevity, preventing risk of obesity, coronary     heart disease, and hypertension, and increasing self-esteem and overall quality of life. The     broad aim of the current study is to investigate the effectiveness of psychoeducational     training to increase exercise activity initiation and maintenance in young adults.      The goal of this study is to compare three training approaches for college students to     increase exercise behavior. One approach provides general information on the different types     of exercises and benefits of engaging in exercise behavior after an initial questionnaire     assessment session. A second approach includes the general exercise information and     questionnaire assessment as well as training on how to create specific goal intentions (i.e.,     implementation intentions) to aid in exercise initiation. A third approach uses all the     components of the second approach but also tests the utility of a personality-informed module     by incorporating concepts from the theory of learned industriousness. It is expected that the     third approach will be the most effective in helping participants initiate and maintain their     exercise activities during the course of the study duration.   "
82651|NCT02204163|"     Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in     infants/toddlers with Prader-Willi syndrome   "
82652|NCT02204150|"     The main purpose of this research is to test the feasibility and tolerability of the tethered     capsule Optical Frequency Domain Imaging (OFDI) screening probe in healthy subjects, patients     with Barrett's Esophagus and Eosinophilic Esophagitis.   "
82653|NCT02204137|"     The purpose of this research study is to look at the use of a series of questionnaires     evaluating risk for falls in order to collect information that might be used to develop a     larger study aiming to recognize who is more at risk for falls and how to best intervene to     prevent falls in older adults with cancer.   "
82654|NCT02204124|"     The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation,     and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess     whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative     morbidity (the presence of illness or disease). The findings will then be compared to     patients whose Whipple procedure will be performed using conventional dissection and     hemostasis techniques.   "
82655|NCT02204111|"     The primary objective of the study is to compare quality of life (QoL) between patients     suffering from soft tissue sarcoma, receiving a multidimensional intervention with those     receiving standard treatment.   "
82656|NCT02204098|"     The purpose of this research study is to find out about the safety of injecting the gene     (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was     purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein     that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way     to generate an immune response to breast cancer cells. There is evidence that an immune     response may be a way to fight cancer. In addition to evaluating the safety of the     mammaglobin-A injection, this study is also looking at the immune response that the     participant's body has after each injection.   "
82657|NCT02204085|"     This research study is studying a targeted therapy known as GO-203-2C as a possible treatment     for with acute myeloid leukemia (AML) both alone and in combination with decitabine.     GO-203-2c targets cancer cells, while leaving healthy cells unaffected.This is a Phase I/II     clinical trial. A Phase I clinical trial tests the safety of an investigational intervention     and also tries to define the appropriate dose of the investigational intervention to use for     further studies.   "
82658|NCT02204072|"     The overall aim of the trial is to investigate the safety and anti-tumour activity of an     experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide,     compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients     that have previously been treated and failed on docetaxel and abiraterone treatments.     Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm     the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide     that can be taken together.      Once the MTD, or recommended phase II dose, have been determined an expansion cohort will     also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a     rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel     or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose,     of BI 836845 and enzalutamide determined in the phase Ib escalation phase.      The randomised trial (phase II) will be an open label, parallel group study design in a 1:1     ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the     MTD/recommended doses, or enzalutamide alone (Arm B).      In all parts of the trial safety, anti-tumour activity will be assessed, in addition to     circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and     determination of Overall Survival (OS).   "
82659|NCT02204059|"     The primary objectives of this study is to assess the safety and tolerability of     intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to     investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in     patients with non-small cell lung cancer (NSCLC)   "
82660|NCT02204046|"     The primary objectives of this study were to assess the safety and tolerability of     intravenously (i.v.) administered 186Rhenium (186Re)-labelled bivatuzumab and to investigate     the biodistribution and pharmacokinetics of 186Re-labelled bivatuzumab in patients with     adenocarcinoma of the breast   "
82661|NCT02204033|"     The general aim of the present study was to assess the safety and tolerability of     intravenously administered Technetium 99m (99mTc) and Rhenium-186 radionuclide (186 Re)     -labelled hMAb BIWA 4, to confirm preferential accumulation in the tumour of 99mTc - labelled     hMAb BIWA 4, to determine the maximum tolerated radiation dose of 186 Re-labelled hMAb BIWA 4     and to propose a safety dose for phase II development.   "
82774|NCT02202564|"     HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and     extrahepatic portal branches participated in the study. Patients were randomized allocated in     liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received     orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered     to patients twice.   "
82663|NCT02204007|"     This is an observer-blinded prospective randomized clinical trial to define the efficacy of a     new technology developed at the Cleveland Clinic to improve the positioning of the acetabular     shell in total hip arthroplasty.The proposed study will enroll patients that have consented     to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This     treatment is standard of care. Patients will receive standard of care pre- and post-operative     care and placement of standard of care implants all of which are commercially available and     FDA approved for general use for the clinical indications used in these patients. The only     difference in treatment between the groups will be the use of a surrogate bone model to help     assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic     testing performed specifically related to this study consists of obtaining one pre-operative     and one post-operative CT scan. The post-operative scan is to be performed within two weeks     of surgery.      The investigators predict that those patients with 3D imaging and bone model will have better     acetabular shell placement than those with standard preoperative planning.   "
82664|NCT02203994|"     Spasticity is the most problematic self-reported secondary medical problem in patients with     spinal cord injury. It has the potential to negatively influence quality of life through     restricting activities of daily living. Problematic spasticity can cause pain and fatigue,     disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a     negative effect on patients morbidity. For this reason there is enormous interest in     therapeutic interventions addressing to decrease spasticity in persons with spinal cord     injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on     spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no     studies are published, assessing the effect of extracorporeal shock wave therapy on focal     spasticity in patients with spinal cord injury.      The purpose of this study is to investigate the effect of a one-time ESWT on lower limb     spasticity in patients with an incomplete spinal cord injury.   "
82665|NCT02203981|"     To determine optimal cut-off value for the TopQ cut-off on the Maestro and 3D OCT-2000.   "
82666|NCT02203968|"     Trauma is the leading cause of death in people 44 years of age or younger. After major     trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting     defects is responsible for most of deaths in the first hours of hospital admission. Of note,     these bleeding-related deaths are potentially preventable. Accordingly, the initial     in-hospital management of severely injured patients focuses on stopping bleeding, replacing     blood loss and correcting clotting defects.      Recently, animal and human research demonstrated that one of the major clotting defects     following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor),     which is detected on hospital admission in severely injured patients. These low fibrinogen     levels are associated with increased blood transfusion and death. However, in North America,     the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which     is a frozen blood product with long preparation time, and similarly to other blood products,     carries the risk of viral transmission and transfusion complications. Alternately, many     Europeans countries where cryoprecipitate has been withdrawn from the market due to safety     concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen inactivation,     which is a process to eliminate the risk of transmitting viruses, bacteria and parasites, is     likely a safer and faster alternative to cryoprecipitate. In Canada, fibrinogen concentrate     is licensed for congenital low fibrinogen only.      Although preliminary data suggest that fibrinogen supplementation in trauma is associated     with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of     early fibrinogen replacement remains unknown. We proposed to conduct a feasibility randomized     trial to evaluate the use of early fibrinogen concentrate against placebo in injured patients     at our trauma centre.      A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering,     and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in     trauma. This feasibility trial will provide preliminary safety and clinical outcome data to     inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths     in the trauma population.   "
82667|NCT02203955|"     The main objective is to compare prebiotic therapy with placebo for the prevention of     pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal     anastomosis. This study will also characterize the effects of prebiotics on the fecal     microbiota and fecal microbial metabolites and correlate these effects with the primary     outcome of development of pouchitis.   "
82668|NCT02203942|"     Vaginitis is the most common condition encountered in the gynecologist's office and is most     commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas     vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be     challenging, and the evaluation of vaginitis by physicians is often substandard.      The investigators will determine whether NAAT testing will improve the diagnosis of vaginal     infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas     vaginalis (TV).   "
82669|NCT02203929|"     Knowledge of the natural history and progression of macular holes is mainly limited to the     studies from the pre-optical coherence tomography era. By observing macular holes     preoperatively we are able to determine the extent of the preoperative macular hole     progression.      At our institution macular holes are treated in an elective setting. The majority of macular     holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation     followed by vitrectomy.      We wish to observe the effect of time and cataract surgery on the progression of macular     holes prior to vitrectomy.   "
82670|NCT02203916|"     The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil     versus placebo in Korean adults with essential hypertension.   "
82671|NCT02203903|"     This Phase I dose-escalation trial is designed to evaluate the safety of administering     rapidly-generated multi-antigen-specific T lymphocytes, to HSCT recipients (group A) or     future HSCT recipients (group B) for the treatment or relapsed or refractory hematopoietic     malignancies.   "
82672|NCT02203890|"     This study will provide the researchers with an opportunity for the investigation of the     biomarkers and different human biology component variable interactions in children;     information that can generate new correlations between markers not known at the moment.      Regarding their analysis, variation could have multiple connotations. A categorical that     refers to a specific state, established with a diagnostic standard. And a numerical,     referring to a range or the absolute value limits in a continuous spectrum; this research     will allow us to express variability in the distance amplitude of the obtained values level,     as well as classifications or categories previously established in the possible cases.      OBJECTIVES PRINCIPAL OBJECTIVE      To estimate the inter and intra-individual variety in a selected series or biological     variables determinant of growth, body composition, infection, oxidation, inflammation and     hydration, in preschool children sharing the same institutional-based diet.      SPECIFIC OBJECTIVES        -  To determine the inter and intra-individual variation of growth in preschool children,          with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system          daycare centers and to compare between semi-urban and rural.        -  To describe the inter-individual variation of the red blood cells circulating mass in          preschool children, with a similar diet, who attend day care centers and to compare          between semi-urban and rural.        -  To determine the inter-individual variation of systemic and intraintestinal oxidation in          preschool children, with a similar diet, who attend daycare centers and to compare          between semi-urban and rural.        -  To describe the inter-individual variation of systemic and intraintestinal inflammation          in preschool children, with a similar diet, who attend daycare centers and to compare          between semi-urban and rural.        -  To determine the inter and/or intra-individual variation of urinary tract infection and          gastrointestinal parasite infestation in preschool children, with a similar diet, who          attend daycare centers and to compare between semi-urban and rural.        -  To describe the inter and intra-individual variation of the hydration status in          preschool children, with a similar diet, who attend daycare centers and to compare          between semi-urban and rural.        -  To explore intra-individual associations in variables of the same research component or          different component variables.   "
82673|NCT02203877|"     To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis     incidence.   "
82674|NCT02203864|"     Evaluation of safety and tolerability of four intradermal injections given at two week     intervals. In addition the efficacy of transferrinfection was determined by quantifying     Interleukin 2 (IL-2), which was locally produced by the implanted, transfected allogenic     melanoma cells at the injection sites. Further determination of tumor specific and clinical     host responses induced or augmented by the treatment were determined.   "
82675|NCT02203851|"     The primary objective of the study is to investigate long-term safety and efficacy of BI     655066/ABBV-066/risankizumab, in patients with moderate to severe chronic plaque psoriasis,     during open-label treatment.   "
82676|NCT02203838|"     This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with     schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000     subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting     clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the     Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness     (CGI-S) scale.   "
82677|NCT02203825|"     This Phase I clinical trial is evaluating chimeric-antigen receptor (CAR) T-cells (CM-CS1 T     cells) which recognize NKG2D-ligands on the surface of cancer cells. This study evaluates the     safety and feasibility of administering a single intravenous dose of CM-CS1 CAR T-cells to     patients with AML, MDS-RAEB and Multiple Myeloma.   "
82678|NCT02203812|"     The oral cavity is mostly influenced by general health. The oral microbiota which is as     complex as the gastro-intestinal or vaginal microbiota are considered to be difficult     therapeutic targets. The effects of probiotics in different fields of health care have     resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been     clinically proved effective in different fields of oral healthcare such as halitosis, oral     candidiasis and tooth decay. They have also been inducted in the field of periodontal     healthcare because of the current views on the etiology of plaque- related periodontal     inflammation.   "
82679|NCT02203799|"     Many children who are allergic to peanuts do not outgrow their allergy and have very severe     allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing,     decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A     severe allergic reaction can lead to death if not treated appropriately.      The purpose of this study is to find out if there is a way to treat children with peanut     allergy to help lower the risk of severe allergic reactions and also cause them to lose their     allergy to peanuts. The approach that will used for this study is a process called     desensitization.      Oral immunotherapy involves eating gradually increasing amounts of a food over several     months. This is a research study because at this time peanut oral immunotherapy (OIT) is     investigational. Peanut OIT (study drug) is investigational because it is not currently     approved for clinical use by the Food and Drug Administration. There are no alternative safe     and effective treatments for peanut induced allergic reactions other than peanut avoidance     and treatment with medications.   "
82680|NCT02203786|"     To determine if:        1. pathological gambling is similar to psychostimulant addiction as reflected by parallel          roles for D1 and D2 receptors in gambling and stimulant reinforcement.        2. these parallel roles are linked with gambling pathology or if they are evident in both          gamblers and controls.   "
82681|NCT02203773|"     This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of     orally administered ABT-199 combined with decitabine or azacitidine and the preliminary     efficacy of these combinations. In addition, there is a DDI sub-study only at a single site,     to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.   "
82682|NCT02203760|"     Study design:      This study is a prospective, randomized, open-label, multicenter phase II trial in order to     determine progression-free survival of patients with refractory or relapsed metastatic     uterine leiomyosarcomas or other metastatic uterine tumours.      Indication:      Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas      Randomization:      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the     following therapy        -  Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d          1 and d 8 q3w or        -  Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be          treated according to Arm A.      Planned number of patients:      87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas      Treatment schedules:      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the     following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once     daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or      • Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with     uterine carcinosarcomas will be treated according to Arm A.      Planned treatment duration per subject:      Patients continue on study treatment until disease progression, death, unacceptable toxicity     or withdrawal of consent for any reason.   "
82683|NCT02203747|"     The purpose of this study is to evaluate visual distortions reported by pseudophakic     patients.   "
82684|NCT02203734|"     This project will investigate the effects of massage therapy on depressed pregnant women. The     investigators expect that massage therapy will improve blood flow from the mother to the     fetus and reduce prematurity and depression.   "
82685|NCT02203721|"     The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS     Symfony Extended Range of Vision IOL.   "
82711|NCT02203383|"     Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is     associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed     with very shallow or absent breathing and is largely due to an exaggerated response to rising     carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac     Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated     contraction of the heart, has been shown to reduce the severity of CSA in some patient     groups. We aim to determine whether this improvement is due to normalization of the body's     response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by     normalizing the brain's response to carbon dioxide.   "
82775|NCT02202551|"     This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral     capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients     with Levodopa Induced Dyskinesia (LID).   "
82686|NCT02203708|"     Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability     of interpersonal relationships, self-image and emotions as well as marked impulsivity. When     patients have children, they are at high risk of severe emotional and relational disturbances     (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support     the effectiveness of parental guidance group to reduce emotional and behavioral difficulties     of children. To our knowledge there are no programs directed to mothers with BPD who received     a controlled evaluation.      From experience with parental guidance, data from the observation of children of patients     with BPD and psychosocial programs directed to patients BPD, we have built for preventive     intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group     sessions providing information (education, childcare, care specific to BPD) and promotes     mother-child interactions (observation, games).      Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to     mothers with a BPD in addition to a minimal intervention (diagnostic announcement and     provision of health care resources) on behavior withdrawal of children at 6 months compared     to a group of mothers receiving only minimal intervention.      Primary outcome: Difference at 6 months between the experimental and control groups on scores     on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).   "
82687|NCT02203695|"     The primary hypothesis of this study is that outcomes for patients with biochemically     recurrent prostate cancer following radical prostatectomy will be improved by the addition of     enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for     further study in the definitive phase III setting. This study builds on the prior success of     high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy     (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6     months) in an effort to minimize adverse effects.   "
82688|NCT02203682|"     The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50     mg/d), administered for 12 weeks, on patients with mild Graves' Orbitopathy (GO).   "
82689|NCT02203669|"     The purpose of this study is to demonstrate the benefits of a structured     occupational/physical therapy program on upper extremity morbidity for patients who have     received bilateral breast reconstruction in comparison to a home therapy program and no     post-operative therapy.      Hypothesis: Patients who engage in therapist-supervised occupational therapy following     bilateral breast reconstruction have less upper extremity morbidity than those patients who     complete a home therapy program or no therapy program.   "
82690|NCT02203656|"     The purpose of this study is to test the feasibility of interventions to accelerate recovery     of muscle mass and function in older adults following acute hospitalization.   "
82691|NCT02203643|"     This study will evaluate the safety and the efficacy of carfilzomib combined with     cyclophosphamide and dexamethasone (CCyd) or lenalidomide and dexamethasone (CRd) followed by     autologous transplantation ASCT or 12 cycles of carfilzomib combined with dexamethasone and     lenalidomide for patients eligible for ASCT with newly diagnosed multiple myeloma. As a     secondary endpoint this study will evaluate the best maintenance treatment between     lenalidomide and lenalidomide combined with carfilzomib.      Four hundred seventy-seven patients, males and females aged > 18 years, enrolled in several     sites, will take part in this study.      The duration of the study is approximately 5 years.   "
82692|NCT02203630|"     Septic shock is a condition that is marked by severe infection causing hypotension requiring     vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign,     an international organization formed for the purpose of guiding the management of sepsis and     septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic     shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as     an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate     cardiac complications. This recommendation is based solely on experience with no scientific     evidence to support this recommendation.      The investigators will conduct an open-label randomized controlled trial (RCT) directly     comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used     in clinical practice for the management of septic shock. The investigators will perform this     study with a population of patients that have septic shock to complete the following aims:      Aim 1: Determine the incidence of tachyarrhythmias.      Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a     lower heart rate.      Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a     higher incidence of new tachyarrhythmias.      Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less     time in tachyarrhythmia.      Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer     complications, including cardiac complications.      The investigators hypothesize that in this setting, phenylephrine will improve the management     of septic shock when used as a first choice vasopressor by:        1. Decreasing the mean heart rate        2. Decreasing the incidence of new tachyarrhythmias        3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new          onset and recurrent tachyarrhythmias        4. Decreasing the number of cardiac complications   "
82693|NCT02203617|"     The Baby Books Project tests whether embedding educational information into baby books can     improve the health and wellbeing of first-time mothers and their young children.   "
82694|NCT02203604|"     This phase II trial studies how well high-dose aldesleukin and ipilimumab works in treating     patients with stage III-IV melanoma that cannot be removed by surgery. Biological therapies,     such as aldesleukin, may stimulate or suppress the immune system in different ways and stop     tumor cells from growing. Monoclonal antibodies, such as ipilimumab, interfere with the     ability of tumor cells to grow and spread. Giving high-dose aldesleukin together with     ipilimumab may work better in treating patients with melanoma.   "
82695|NCT02203591|"     The objective of the study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA     Prep on skin flora of the abdomen and inguinal regions of human subjects.   "
82696|NCT02203578|"     This pilot clinical trial studies romidepsin in treating patients with graft-versus-host     disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an     effective treatment for graft-versus-host disease caused by a bone marrow or stem cell     transplant.   "
82697|NCT02203565|"     This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in     patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin     condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's     solution may help reduce dermatitis caused by radiation therapy.   "
82698|NCT02203552|"     This randomized clinical trial studies how well minocycline hydrochloride works in reducing     chemotherapy induced depression and anxiety in patients with stage I-III breast cancer.     Minocycline hydrochloride may prevent changes in memory and thinking and improve the quality     of life of breast cancer patients receiving chemotherapy.   "
82699|NCT02203539|"     The purpose of this study is to determine if an exposure to light in the evening has a     positive influence on physical performance regarding endurance, strength and reaction time.   "
83235|NCT02196519|"     A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the     anastomotic junction created during a stoma reversal procedure.   "
82700|NCT02203526|"     BACKGROUND:        -  Primary CNS lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma.        -  The outcome for patients with this diagnosis is significantly worse than for that of          systemic DLBCL. Most treatment approaches in the past have included high dose          methotrexate and radiation treatment.        -  Most PCNSLs appear to be of activated B-cell (ABC) origin.        -  Ibrutinib is an inhibitor of Bruton s tyrosine kinase (BTK) and effective for systemic          DLBCL of ABC origin.        -  We propose doing a study in which ibrutinib is combined with a novel chemotherapy          platform called dose adjusted temozolomide, etoposide, doxil, dexamethasone, ibrutinib,          rituximab (DA-TEDDI-R).      OBJECTIVE:      - Identify the maximum tolerated dose (MTD) of ibrutinib or the dose that achieves adequate     CSF concentrations, whichever comes first, when ibrutinib is given with DA-TEDDI-R.      ELIGIBILITY:        -  Newly diagnosed or relapsed/refractory PCNSL.        -  Age greater than or equal to 18 years.        -  No pregnant or breast-feeding women.        -  Adequate organ function (defined in protocol).      STUDY DESIGN:        -  This is a phase 1 study of 40 patients.        -  The study will have two components.             1. Phase 1: MTD of ibrutinib will be identified or the dose at which ibrutinib               achieves a concentration of less than or equal to 100 nM in the CSF, when given in               combination with DA-TEDDI-R immuno-chemotherapy, whichever comes first.             2. Expansion cohort: Safety and tolerability of the regimen in relapsed/refractory or               previously untreated PCNSL (DLBCL type) will be assessed at the final ibrutinib               dose with DA-TEDDI-R in 10 patients. Secondary objectives will be PFS and OS.   "
82701|NCT02203513|"     Background:        -  All cells go through cycles which allow them to divide. In normal cells, Chk1 and Chk2          (Chk1/2) stop cell division at various points to allow any damage to DNA to be repaired.        -  When Chk1/2 are not present, cells stop dividing and eventually die. LY2606368 blocks          the Chk1/2 proteins.        -  Researchers hope that by blocking Chk1/2, it will cause tumor cells to die, thereby          shrinking tumors.      Objective:      - To see if LY2606368 helps shrink tumors in patients with certain breast, ovarian or     prostate cancers.      Eligibility:      - Patients at least 18 years old with breast or ovarian cancer. They must have a mutation in     BRCA1/2 genes for group 1, high grade serious ovarian cancer without BRCA1/2 mutation for     group 2, or triple negative breast cancer without BRCA1/2 mutation for group 3, or prostate     cancer with or without BRCA1/2 mutation for group 4.      Design:        -  Participants will be screened with a medical history and physical exam. They will have          blood tests, an electrocardiogram (ECG) heart test, scans, and X-rays. They will have a          piece of their tumor removed at entry (CT-assisted biopsy).        -  Study Day 1: Participants will have a physical exam and blood drawn. They may have a CT          scan of the chest, abdomen, and pelvis.        -  Day 1 and Day 15 of each 28-day cycle: Participants will receive the study drug through          an IV.        -  Vital signs will be checked before and after. An ECG will be done within 1 hour after.        -  Day 15 and Day 28: Participants will have a physical exam, blood drawn, and a 12 lead          ECG.        -  Cycle 1: Participants will have weekly phone calls and blood draws. Participants may          have another CT-assisted biopsy at the end of cycle 1.        -  Cycle 2 and beyond, blood will be drawn every other week for routine blood tests.        -  Participants will have an after-study visit with a physical exam and blood tests.          Participants may have another biopsy when they progressed on treatment. They will have          scans of the chest, pelvis, and abdomen and a 12 lead ECG.   "
82702|NCT02203500|"     The objectives of this study are to compare the steady state pharmacokinetics of lacidipine     with and without the co-administration of telmisartan and to compare the steady state     pharmacokinetics of telmisartan with and without the co-administration of lacidipine   "
82703|NCT02203487|"     The objective of the present study was to obtain information about the safety and     tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics     data (steady state and accumulation factor)   "
82704|NCT02203474|"     The primary objective of this study is to demonstrate the superiority of tiotropium     hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated,     once-daily dosing.   "
82705|NCT02203461|"     Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after     14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by     hyperinsulinemic euglycemic clamp.   "
82706|NCT02203448|"     A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the     FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to     Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior     instrumentation. The objective of this study is to assess outcomes following implantation of     the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.      The primary objective of this study is to determine the rate of re-operations at the index     level(s).      The secondary objectives of this study are to confirm the safety and performance of the     device and to collect patient reported outcome data.   "
82707|NCT02203435|"     This study aimed to retrospectively examine patients evaluated by the Code Blue team on a     Code Blue call in our hospital between 2009 and 2013.      Primary outcome: an examination of the survival rates and demographic data of the patients     evaluated as an emergency by a Code Blue call in the period 2009-2013.Secondary outcome: to     determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the     relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients     throughout the whole hospital for whom a Code Blue form was completed and who were evaluated     by the Code Blue team on a Code Blue call.      Exclusion criteria: patients who refused treatment   "
82708|NCT02203422|"     The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known     hospitals in China. In order to report the efficacy and safety of recombinant human     thrombopoietin combining with cyclosporin A for the treatment of adults with refractory     immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.   "
82709|NCT02203409|"     The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a     single center. The validity, feasibility and limitations were assessed objectively through     our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective     and feasible.   "
82710|NCT02203396|"     Severe acquired aplastic anaemia (SAA) is a bone marrow failure disease characterized by     pancytopenia and a hypocellular bone marrow. The corn pathophysiological mechanism is the     destruction of hematopoietic stem/progenitor cells mediated by auto-reactive effector T     cells. Immunosuppressive therapy with horse antithymocyte globulin (ATG) plus cyclosporine     (CSA) is currently the standard of treatment in patients with aplastic anaemia who are not     eligible for bone marrow transplantation and with response rates from 40% to 70%. Previous     studies showed that horse ATG (hATG) is apparently more effective than rabbit ATG (rATG) as     the latter has higher treatment related mortality (TRM). Unfortunately hATG is unavailable in     China, so we conduct a optimized standard treatment (9 days protocol) of rATG plus CSA and     Levamisole (LMS) Sequential maintaining (termed Optimized Standard Protocol, OSP) for severe     aplastic anemia. This prospective study is designed to evaluate the efficacy and safety of     Optimized Standard Protocol as first line therapy in newly diagnosed severe aplastic anemia     patients.   "
82712|NCT02203370|"     Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM     Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy,     Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with     crossclamped internal carotid artery (ACI). All procedures will be performed in regional     anesthesia, therefore the patients will be awake and direct neurological examination during     the procedure will be possible, giving information how the drop in cerebral saturation     (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical     symptoms.      We expect to see a difference in the total drop and in the delay of the drop of cerebral     oxygen saturation, making it possible to detect varieties in specificity and sensitivity of     both devices compared to neurologic examination in the awake patient.   "
82713|NCT02203357|"     The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody     persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine     with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young     adults, and the comparative immunogenicity among the three groups will be measured at 1 mon     post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore,     the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.   "
82714|NCT02203344|"     Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes     in adult intensive care unit (ICU) patients. The revised guidelines for management of pain,     agitation and delirium by the Society of Critical Care Medicine in 2013 also recommended that     adult ICU patients should be maintained at a light level of sedation. The key point in light     sedation strategy is the assessment of depth of sedation. At present, sedation is monitored     mainly by the subjective clinical score systems, such as the Ramsay Scale, the Riker's     Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). However, the     subjective and intermittent nature of these scales instruments has limited their application     in light sedation algorithm. Consequently, objective and continuous measurement of the level     of sedation would be more desirable in clinical practice. In recent years, objective measures     of brain function have been of great interests in the evaluation of sedation level, and     bispectral index (BIS) has been the most investigated instrument.      Several studies compared BIS with subjective sedation scales in adult ICU patients, and     yielded conflicting results. The different approaches to select BIS value may be the most     important reason for these inconsistent agreements between BIS and subjective sedation     scales. A formal scheme of subjective assessment of the depth of sedation and level of     consciousness should incorporate exerting verbal and physical stimuli and observation of the     patient's subsequent responses. Our primary aim is to clarify the diagnostic accuracy of BIS     in detecting early deep sedation against the reference standard of subjective scale     instrument. We hypothesize that BIS monitoring will provide accurate, subjective and     continuous evaluation of deepen sedation.   "
82715|NCT02203331|"     Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new     treatment option for patients with endometriosis-associated pelvic pain   "
82716|NCT02203318|"     The aim of this study is to verify whether the hypertrophy of contralateral testis may     predict the absence of the non-palpable testis in the boys younger than 24months of age.     According to the previous studies of other countries, the large size of the contralateral     testis of the nonpalpable testis has positive correlation woth the weak viability of the     affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups     are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but     not normally descended testis group(group2) and control group(group3). The size of testis     will be measured with Ultrasound and the length, width and the height will be measured before     surgery at outpatient department. For the group 1 & 2, the viability of the affected testis     will be evaluated and compared after surgery. In addition the comparison with normal control     group is also going th be conducted.   "
82717|NCT02203305|"     The primary goal of this project is to determine whether subjects with Single-Sided Deafness     (SSD) experience an improvement in speech perception, localization, and quality of life with     a cochlear implant as compared to an unaided listening condition.   "
82718|NCT02203292|"     TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two     red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients   "
82719|NCT02203279|"     Purpose: The purpose of this study is to evaluate three hard relining materials after 3 and 6     months of use with mandibular complete dentures. The effect of hard relining materials on     supporting tissues and patients' satisfaction will also be assessed.      Materials and Methods: 36 complete edentulous patients who already have maxillary dentures     and complaining of instable mandibular dentures will be invited to participate in this study.     Mandibular dentures will be relined randomly by one of three relining materials: two     chairside relining materials (Tokuyama Rebase II Fast, Tokuyama Dental Co, Japan), and     (Flexacryl Hard, Lang Co, USA) and one heat cured acrylic resin (Vertex, Dental technology     Co, Holland).      The color stability of relining material, peeling, and the effect on supporting tissue will     be assessed by two separate prosthodontists after 3 and 6 months of follow up. In addition,     patients will be asked to grade there overall satisfaction on a Visual Analogue Scale (VAS)     ranging from 0 to 100.   "
82720|NCT02203266|"     The purpose of this trial is to discover whether providing feedback to patients from a device     that records when and how well a patient uses a Seretide Diskus inhaler will lead to:        -  Improved compliance with prescribed inhaler use        -  Improved technique of inhaler use        -  A reduction in respiratory health related outcomes caused by poor inhaler compliance and          usage.        -  An improvement in patient quality of life scores   "
82721|NCT02203253|"     This study was aimed to evaluate efficacy and tolerability of thalidomide in improving     prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients     after highly emetogenic chemotherapy.   "
82722|NCT02203240|"     The purpose of this study is to determine the impact of consuming cocoa on blood glucose     levels, glucose metabolism, and other markers of pre-diabetes in overweight and/or obese     individuals. Our hypothesis is that consumption of cocoa improves insulin sensitivity and     glucose metabolism in subjects at risk for developing type-2 diabetes.   "
85080|NCT02172391|"     Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in     COPD patients as measured by inspiratory capacity (IC).   "
82725|NCT02203201|"     The most frequent diseases caused by wheat ingestion are T cell-mediated disorders, i.e.     celiac disease and immunoglobulin E (IgE)-mediated allergic reactions. However, besides     celiac disease and wheat allergy, there are cases of gluten reactions in which neither     autoimmune nor IgE-mediated allergic mechanisms are involved. These are generally defined as     GS or Not-celiac wheat sensitivity (NCWS). Typically, NCWS diagnosis is made by exclusion,     and an elimination diet and an open challenge (i.e., the monitored reintroduction of     gluten-containing foods) are most often used to evaluate whether health improves or worsen     with the elimination or reintroduction of gluten in the diet, respectively. In some     circumstances, it is very difficult to distinguish between NCWS and celiac disease. The     presence of positive celiac disease specific serum antibodies (anti-tissue transglutaminase     (anti-tTG), and anti-endomysium (EmAs) antibodies) is of paramount importance to pose the     diagnosis. However, it is well known that the frequency of a positive serology is dependent     by the severity of the intestinal damage. Consequently, patients with less severe histology     damage (Marsh 1) can have negative serum antibodies. Previous studies had demonstrated that     EmAs are produced by the intestinal lymphocytes and previous data from our group showed that     EmAs assay in the culture medium of the intestinal biopsies has higher diagnostic accuracy     than serum EmAs in diagnosis. Therefore, the aims of our study are to evaluate the     clinical-serologic-histology course of NCWS patients, showing positive EmAs assay in the     culture medium of the duodenal biopsies at the time of the first evaluation, and the     adherence to a gluten-free diet in NCWS patients after a previous full evaluation and a NCWS     diagnosis based on double-blinded placebo-controlled (DBPC) challenge.   "
82726|NCT02203188|"     Sjogren's Syndrome is an autoimmune condition in which the body attacks its own glands in the     body. Some of these glands are responsible for providing lubrication for the eye. As a     result, individuals with Sjogren's Syndrome often experience dry eye. Recently, a study had     shown that dry eye symptoms were improved by removing debris and old skin cells along the     eyelid margin. This technique is called eyelid debridement-scaling. The purpose of this study     is to determine how well this technique works in improving dry eye signs and symptoms in     individuals with Sjogren's Syndrome.   "
82727|NCT02203175|"     Pain on injection of propofol is a comman problem. The investigators planned to evaluate the     effect of propofol-fentanyl mixture on propofol injection pain and compare it with fentanyl     pretreatment and control groups.      Following ethics committee approval, 150 ASA I,II patients (18-65 yr) undergoing general     anesthesia were enrolled to this study. Exclusion criteria were communication difficulty,     psychiatric, neurologic disorders and history of allergy. Patients were randomly assigned to     one of tree equal groups. Before the anesthesia induction, Group C (Control, n=50) and group     M (mixture, n=50) received 5 ml isotonic saline, group F (fentanyl, n=50)received 2micgr/kg     fentanyl. 10 seconds after the study drugs had been given, a standart question about the     comfort of the injection was asked to the patient. The investigators used the verbal rating     scale (VRS) for evaluation of propofol injection pain. Statistical analyses were performed     with Student's t and Fisher's exact tests; p value <0,05 was considered significant.      Demographic data was similar among the groups (table I) In group M, the number of the     patients having propofol injection pain was significantly lower compared to groups F and C     (p<0,001 for both) None of the patients in groups F and M experienced severe pain whereas 24     patients (48%) had severe pain in group C (p<0.001 for both).      This study shown that fentanyl-propofol mixture is more effective compared to both fentanyl     pretreatment and placebo in preventing propofol injection pain.   "
82728|NCT02203162|"     Although electronic cigarettes (e-cigs) are now widely used, very little information exists     regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim     of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30     seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.   "
82729|NCT02203149|"     This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese     participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding     study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose     determined in Part I in combination with elbasvir. The primary study hypothesis is that the     percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who     achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be     greater than the reference rate of 75%. A separate study arm for cirrhotic participants will     also be included in Part II; these participants will receive grazoprevir at the determined     dose in combination with elbasvir.   "
82730|NCT02203136|"     The goal of this research study is to improve detection of cancer outside of the bladder     through genetic testing and improved imaging.   "
82731|NCT02203123|"     -  There is no definite tool for measurement of dehydration in children        -  Subjective clinical dehydration scale is considered as valuable scoring system, but it          cannot be reliable among clinicians sometimes.        -  Some authors found Inferior vena cava/Aorta ratio can be a objective marker for          dehydration        -  However, there is no evidence of correlation between clinical dehydration scale and          inferior vena cava/aorta ratio        -  We will observe correlation between clinical dehydration scale and inferior vena          cava/aorta ratio and change of the ratio according to hydration with intravenous normal          saline infusion.   "
82732|NCT02203110|"     The purpose of the study is to determine if the clinical course of pneumonia is more severe     when both, bacterial and viral pathogens are find as possible causative agent and how does it     affect treatment.   "
82733|NCT02203097|"     Purpose:      The purpose of this study is to examine the effect of different carbon-dioxide concentrations     on cerebral CO2 sensitivity and the resistance and stiffness of systemic arteries during     anesthesia with target-controlled infusion anesthesia using intravenous propofol. Propofol is     a widely and commonly used intravenous anaesthetic, that is mainly used for the induction of     general anesthesia and the maintenance of total intravenous anaesthesia (TIVA).      Changes in the velocity of cerebral blood flow and arterial stiffness due to the different     exhaled carbon-dioxide concentrations will allow us to conclude how propofol affects these     parameters during the course of the narcosis.      Instruments:      An ultrasound device called transcranial doppler (TCD) is used to measure the velocity of     blood flow within a main artery located inside the skull.      A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in the     radial artery, from which the stiffness of the systemic vessels can be concluded.      Measurements:      - Examinations with the ultrasound and tonometry devices are carried out once before the     operation, three times during the intervention, with different exhaled CO2 values and once     after the operation is completed.      Hypothesis:      - Propofol alters cerebral carbon-dioxide sensitivity and the stiffness of systemic arteries     during TCI anaesthesia.   "
82776|NCT02202538|"     This study will evaluate the Indego® device for safety and effectiveness at allowing persons     with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of     conditions.   "
82734|NCT02203084|"     Anyone who practices clinical medicine will understand that socially disadvantaged children     will have worse health outcomes, no matter what the underlying condition might be. There is     limited prospective data on the effects of social deprivation on children in BC and there is     none concerning the effects of social deprivation on children with chronic diseases. In order     to generate relevant data for those who manage children with chronic diseases in BC, the     investigators wish to perform an observational study of the relationship between     questionnaire-derived social variables and measured outcomes in children with cystic     fibrosis, type 1 diabetes, and chronic kidney disease.      Our working hypothesis is that there is an association between social determinants of health     (income, education, race) and health outcomes in children with cystic fibrosis, type 1     diabetes and chronic renal failure, that is independent of access to health care (assessed by     distance to nearest specialty clinic and number of clinic visits in the last year).   "
82735|NCT02203071|"     Subjects will be selected among the investigators' patient population who are already     scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of     BioCartilage.      During the surgical operation for MSP, a portion of the patient's blood is taken out and used     to form a patch to cover a cartilage defect of the knee. Currently it is considered standard     of care to either form the patch using only a portion of the patient's blood, or form the     patch using a portion of the patient's blood combined with an FDA-approved augmentation such     as BioCartilage.      This study will collect outcomes data and MRI for patients that are undergoing MSP with and     without BioCartilage augmentation, then compare the data between those who received     BioCartilage and those who did not.      The primary endpoint is to determine whether subjects receiving a marrow stimulating     procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of     life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without     the use of BioCartilage.   "
82736|NCT02203058|"     Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and     consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD)     patients. It has not been completely elucidated whether pursed-lips breathing (PLB) is able     to minimize DH and its effects on exercise tolerance in these patients. The aim of this study     was to evaluate the acute effect of PLB on DH and functional capacity in patients with COPD.      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient     pulmonary rehabilitation program in Florianópolis, Brazil.      Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)%     predicted, BMI=27.6 (5.13)kg/m2).      Interventions: Patients will randomly perform two six-minute walk tests with and without PLB     (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and     TGlittreNon-PLB).      Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC)     will be assessed by the slow vital capacity (SVC) maneuver.   "
82737|NCT02203045|"     The overall goal of this study is to determine the effects of intraoperative tourniquet use     during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet     (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During     the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity     while the contralateral lower extremity undergoes TKA without the use of a tourniquet     (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in     TKA to improve visualization of the surgical field and limit blood loss. However, studies     suggest that tourniquet use may be associated with higher rates of medical complications and     poor functional outcomes, including increased swelling, decreased muscle strength and altered     neuromuscular activity. We will measure strength, voluntary muscle activation, and other     functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs     after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities     in the NOTQT group will demonstrate improved strength and performance when compared to lower     extremities in the TQT group.   "
82738|NCT02203032|"     The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in     the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash)     who had inadequate response to ustekinumab.   "
82739|NCT02203019|"     Patients with infections in their blood often become very sick. These patients are usually     put in an intensive care unit for careful observation and treatment. These patients may     develop a low blood pressure, lung failure, and kidney failure. When these problems develop,     care becomes quite complicated. Patients with lung failure often need help with a breathing     machine to make certain that the breathing is adequate. The machine helps keep the oxygen     level high enough for healthy tissues. When patients are placed on the machine for breathing     they require a tube to be placed into lungs. This can be quite uncomfortable. These patients     need sedation to help them tolerate the uncomfortable breathing tube and other parts of their     routine necessary care. This study will compare two drugs (dexmedetomidine and propofol)     which are frequently used for sedation in intensive care patients. Clinical studies suggest     that these drugs are both effective and safe. The main question is whether or not one of the     drugs is better in a patient with a blood infection. This study will try to determine that.     Our main goal is to see whether or not patients on one particular drug come off the breathing     machine faster than patients on the other drug. These drugs are not experimental drugs and     are approved by the Food and Drug Administration. There is no placebo drug being used in this     study. All patients in this study will receive the best possible care based on their medical     condition.   "
82740|NCT02203006|"     The purpose of this study is to improve our knowledge concerning HIV infection, treated or     not, in the current conditions of care to optimize it.   "
82741|NCT02202993|"     This is a dose-escalation study that will assess the safety and determine the maximum     tolerated dose (MTD) of mibefradil dihydrochloride, a partially selective T-type calcium     channel blocker, combined with hypofractionated radiation therapy (RT) in subjects with     recurrent glioblastoma multiforme (GBM).   "
82742|NCT02202980|"     This study will evaluate the antiviral efficacy, safety, and tolerability of combination     therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.   "
82822|NCT02201940|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with     chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.   "
82743|NCT02202967|"     Anti-inflammatory tablets (non-steroidal anti-inflammatory drugs) continue to be used     commonly worldwide to relieve pain caused by arthritis. Likewise, aspirin is used by many     patients in order to prevent blood clots. Despite their desired benefits, these medicines can     cause internal bleeding from the digestive system. The source of this bleeding can be obvious     (overt), or obscure and thought to come from the small intestine. Obscure bleeding can show     as anemia due to lack of iron in the blood. Small intestine ulcers are now easily diagnosed     using an endoscope the size of a big pill (video capsule endoscopy). Small bowel ulcers are     not related to stomach acid and therefore do not heal using remedies usually taken to stop     acid formation. A different drug, misoprostol, consists of a chemical (prostaglandin) that is     usually lacking in patients using aspirin or anti-inflammatory drugs. Misoprostol is licenced     to heal stomach and duodenal ulcers in patients using these drugs. Our hypothesis is that     misoprostol might be effective in healing small bowel ulcers as suggested by pilot studies;     however, such works only included small numbers of patients, did not include control groups     and both patients and investigators knew the nature of the tablets used. To test this     hypothesis, we propose to compare misoprostol to a dummy tablet. The numbers of subjects to     be studied have been calculated using established statistical methods   "
82744|NCT02202954|"     In the situation of motor limitations that people often experience after stroke, current     health systems cannot provide for the daily amount and duration of high intensity muscle     stretch and motor training that would be required over protracted periods to involve muscle     and brain plasticity. For patients with sufficient cognitive abilities, Guided     Self-rehabilitation Contracts allow implementing stretch and training at high intensity and     may result in meaningful functional improvement in chronic stages, as long as discipline     persists over at least a year span.      This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as     against conventional therapy in the community, for a one year duration in persons with     chronic hemiparesis after stroke.   "
82745|NCT02202941|"     This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten     duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.   "
82746|NCT02202928|"     The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed     dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).   "
82747|NCT02202915|"     This study examines a training program for clinicians who work in mental health clinics that     serve children with OCD. We will provide clinician training in conducting exposure-based     treatments for children with OCD. The purpose of the project is to test the use of a new tool     to enhance training in exposure-based treatments for clinicians. Therapists will receive     training and oversight from the researchers regarding the treatment procedures and use of the     new tool. All children enrolled in the study will receive treatment by clinicians who are     participating in this study. Therapists and youth will be recruited separately for the study     and will be assigned to work together.   "
82748|NCT02202902|"     This study aims at evaluating the myocardial triglyceride content and cardiac structure and     function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in     patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched     healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients     compared to healthy subjects present with excess lipid storage in cardiac myocytes,     reversible upon correction of hypercortisolism.   "
82749|NCT02202889|"     School based educational intervention to educate on bone health among Hispanic, Asian or     non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium     intake and bone density in . The hypothesis was that the educational program would increase     knowledge, improve dairy food and calcium consumption and enhance bone health in this     population. A secondary hypothesis was that lactose maldigestion would be an impediment to     improved dairy food consumption.   "
82750|NCT02202876|"     Cystic fibrosis-related diabetes (CFRD) occurs in almost 20% of teens and 50% of adults. The     investigators' long term goal is to determine the cause of CFRD in order to translate this     knowledge into therapies aimed at preventing CFRD. Since CFRD and type 2 diabetes share     several clinical features and since oxidative stress is a key factor in the development of     type 2 diabetes, the investigators explored the role of oxidative stress in CFRD. The     investigators discovered a unique CF biochemical signature that they believe could be     implicated in the development of CFRD. The investigators found that glucose ingestion in CF     teens and young adults causes an acute and profound systemic redox imbalance to the oxidizing     state. The degree of redox imbalance was quite severe and would be expected to damage the     insulin producing cells as these cells are particularly vulnerable to oxidative stress. Thus,     these findings could prove to be a critical factor in the pathogenesis of CFRD. This proposal     will test the hypothesis that glucose-induced redox imbalance is an intrinsic, metabolic     defect in CF. In addition, because CF people are required to consume a high calorie diet to     maintain their weight, the investigators also hypothesize that certain high caloric foods     will recapitulate the redox imbalance induced by ingesting glucose and thus hasten the     development of CFRD. Specifically, the investigators aim to:        -  Determine whether young children with CF have glucose-induced redox imbalance        -  Determine whether eating a meal with a high glycemic index induces acute redox imbalance   "
82751|NCT02202863|"     Lifestyle modifications, including healthy food intake, exercise, and suppression of tobacco     smoking, constitute the most powerful tool to fight chronic diseases. Antioxidants and fiber,     two components of Mediterranean diets, are key functional elements for healthy eating and     nutrition. We prepared flour from wine grape pomace (WGPF), a rich source of antioxidant and     fiber, to be used as an ingredient for functional foods and as a dietary supplement to     increase the intake of dietary fiber and bioactive compounds. WGPF was obtained from red     grapes (Cabernet Sauvignon variety, Chile). The byproduct of pressing crushed grapes after     alcoholic fermentation was dried, grounded and stored. The purpose of this study is to     determine the effects of red wine grape pomace flour intake on glycaemia, plasma lipid     profile, plasma antioxidants (vitamin C and E), oxidative stress and inflammatory markers.   "
82752|NCT02202850|"     Determine which remission criterion at Month 6 predicts remission at Month 12 the best.   "
82753|NCT02202837|"     Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life     Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept   "
82755|NCT02202811|"     The purpose of this study is to understand how behaviors and the effects of the body's     internal clock (called the circadian pacemaker) affect the control of the heart and blood     pressure.      People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian     amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian     phase in some of the same key indices of CV risk. The investigators hypothesize that such     changes, taken together, may explain the different timing of heart attack and sudden cardiac     death in OSA.   "
82756|NCT02202798|"     Over the past 5 years, there has been a change in clinical practice with the use of cuffed     instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies     have recently introduced syringe-like devices to the market which allow the measurement of     the intracuff pressure. This study proposes to prospectively compare the intracuff pressure     from these devices with the gold standard technique (manometer).   "
82757|NCT02202785|"     The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in     patients with advanced or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the     pancreas.   "
82758|NCT02202772|"     The investigators intend to evaluate the safety and toxicity proﬁle of intravesically     administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment     refractory Transitional Cell Carcinoma.The investigators propose to conduct a combined phase     I trial to assess the safety, toxicity, and efﬁcacy of a novel multidrug intravesical regimen     consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG resistant     non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will have a     combined dose and cycle-escalation scheme with enrollment of up to 24 patients.   "
82759|NCT02202759|"     The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in     patients with recurrent or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the     stomach or gastroesophageal junction.   "
82760|NCT02202746|"     The purpose of this study is to determine whether lucitanib is safe and effective in the     treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment     of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.   "
82761|NCT02202733|"     The primary goal of the study is to use an iterative process to develop and refine a     skill-based cooking intervention to decrease the consumption of energy from foods prepared     away from home for evening meals, decrease energy intake, and promote a healthy weight in     parents and children aged 3-10 years.   "
82762|NCT02202720|"     Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of     Minimum alveolar concentration of sevoflurane during sedation of patients in ICU   "
82763|NCT02202707|"     The purpose of this study is to preliminarily determine whether the frequency and/or severity     of vasomotor symptoms (VMS) at baseline, and then after symptom reduction with gabapentin,     relates to various cardiovascular control measures.   "
82764|NCT02202694|"     Aim:      To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in     Pakistan.      Design:      Randomized Control Trial      Setting:      Psychiatry Departments of General Hospitals in Karachi.      Participants:      A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a     psychological intervention or treatment as usual arm.      Intervention:      Culturally Adapted Cognitive Behavioral Therapy (CBT)      Outcome measure:      Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)   "
82765|NCT02202681|"     The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule     to image the duodenum.      A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake     and unsedated and ask for their feedback. Images will be taken using the OFDI system while     the capsule travels from the esophagus into the stomach and into the duodenum.   "
82766|NCT02202668|"     The primary translational research objective of the study is to demonstrate feasibility of     using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This     study represents an initial evaluation of the device in a small cohort of human patients with     diabetic foot ulcers. We will be evaluating safety, device design and certain human     engineering factors associated with point of care use of the TRS. We anticipate the data we     collect in this study will form the basis of later medical device studies.   "
82767|NCT02202655|"     The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy     course of patients with non-small cell lung cancer   "
82768|NCT02202642|"     Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion     of limbal stem cells for the treatment of patients suffering from unilateral limbal stem cell     insufficiency based on the concept of limbal stem cells need special cell-cell contact and     cell-extracellular matrix interaction to support their survival.   "
82769|NCT02202629|"     Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the     effect of different combinations of plant based extracts on cognitive function and cerebral     blood flow.   "
82770|NCT02202616|"     This is a single cohort, prospective post approval study conducted on patients with COPD in     Canada. The study will enroll patients that have not responded to their current treatment of     tiotropium alone, or who are on the fixed dose combinations fluticasone     propionate/salmeterol. Only patients for whom the physician has decided to change treatment     due to lack of efficacy will be eligible to be enrolled in the study.      Also will evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium     50 mcg) in the management of patients.   "
82771|NCT02202603|"     A Double blinded (oral), Open Label, Study to Assess the Safety, Pharmacokinetics and     Pharmacodynamics of Oral PTH (1-34) in healthy Subjects to establish the safety,     tolerability, bioavailability, pharmacokinetic, and pharmacodynamic profile and the of     Entera's oral PTH(1 - 34) in adult healthy human volunteers.   "
82772|NCT02202590|"     The goal of this study is to test the feasibility and the tolerability of a tethered     spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.   "
82773|NCT02202577|"     Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior     to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean     related surgical site infection.   "
82777|NCT02202525|"     The main purpose of this prospective, multicentre, french observational study is to analyse     the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive     patients three months after initiation of a new hypertensive therapy. The PP is defined as     the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).   "
82778|NCT02202512|"     Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed     by iohexol clearance in healthy male normovolemic subjects after oral administration of     single and repeated doses of BI 1060469, and BI 1021958.      The secondary objective of this trial is to investigate the glomerular filtration rate (GFR)     as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral     administration of single and repeated doses of BI 1060469, and BI 1021958.   "
82779|NCT02202499|"     The purpose of this Pilot feasibility study is to find out the effect of different behavioral     treatments along with different duration of a drug called varenicline, on smoking behavior     and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that     has been shown to help people quit smoking.   "
82780|NCT02202486|"     Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our     hypothesis that we will test in this study is that the blood-brain barrier breaks down during     migraine attacks but not out side attacks using MRI.      Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported     in migraine patients outside migraine attacks. What happens during migraine attacks has never     been investigated. The hypothesis we will test is that pain related networks are affected     during spontaneous attacks using functional MRI.      Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with     migraine with aura, but not in those without aura. We hypothesize that CBF is altered     regionally during attacks, which we will investigate in this study using arterial spin     labeling (ASL).      Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been     suggested but never investigated during migraine attacks. Our hypothesis is that pain related     structures show altered VBM during spontaneous migraine attacks.   "
82781|NCT02202473|"     The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine     Combination Therapy and whether it could lower the incidence of Lamivudine long-term     resistance compared to Lamivudine Monotherapy.   "
82782|NCT02202460|"     Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and     MRI.   "
82783|NCT02202447|"     The purpose of this study is to determine the safety of EC1169 and the best dose to use in     humans in future studies. This study will also determine how EC1169 is distributed, broken     down, passed and absorbed through your body and how quickly it is eliminated (leaves the     body). All patients will receive EC1169.      As a secondary objective in Part A: To explore the relationships between baseline PSMA     expression (tumor and patient level) as measured by 99mTc-EC0652 scans and the antitumor     activity of EC1169.      As an exploratory objective in Part B: To assess EC0652 as a predictive biomarker for the     efficacy of EC1169 by comparing PSMA-positive and PSMA-negative lesions for response.   "
82784|NCT02202434|"     The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve     System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in     symptomatic subjects with calcific, severe native aortic stenosis who are considered at     extreme or high risk for surgical valve replacement.   "
82785|NCT02202421|"     This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy     of T-ABA with combined parent training and individual child sessions versus T-ABA with     individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a     form of behavior therapy used to promote skill development and reduce disruptive behavior in     individuals with autism. Four key outcome assessment points will be used: baseline (week 0),     midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving     T-ABA parent training only will be offered eight individual therapy sessions at the end of     the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up     assessment.   "
82786|NCT02202408|"     In this Phase I study, the primary objective is to investigate the safety and tolerability of     SKI2670 after oral administration in healthy female subjects. And secondary objective is to     investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in     healthy female subjects.   "
82787|NCT02202395|"     The purpose of this study is to investigate the efficacy and safety of Hydroxytriptolide(LTS)     in active rheumatoid arthritis patients with an inadequate response to methotrexate.   "
82788|NCT02202382|"     Objective: Several in vitro studies report positive effects of ginseng on spermatogenesis.     However, no controlled human clinical study of the effect of Korean red ginseng (KRG) on     spermatogenesis has been performed. This study was performed to investigate the effects of     KRG on semen parameters in male infertility patients in a randomized, double-blind,     placebo-controlled study. Methods: A total of 80 male infertility patients with varicocele     were recruited from April 2011 to February 2012. The subjects were then divided into the     following four groups: non-V + P group, placebo; V + P group, placebo and varicocelectomy;     non-V + KRG group, 1.5-g KRG daily; V + KGR group, 1.5-g KRG daily and varicocelectomy. Semen     analysis was performed and hormonal levels were measured in each treatment arm after 12     weeks.   "
82789|NCT02202369|"     The purpose of this study is to determine if post-operative pain and rate of recovery are     improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to     usual analgsic care.   "
82790|NCT02202356|"     This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect     of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial     virus (RSV)   "
82791|NCT02202343|"     School based Health and Nutrition Education (SHNE) is a key component of school health and     nutrition programs that can address several health and nutrition issues in Ethiopia.   "
82792|NCT02202330|"     Two thirds of all strokes happen in developing countries like Pakistan. There is a serious     lack of health literacy regarding survival after stroke. We hypothesize that our set of 5     minute videos that teach important skills to stroke survivors and their caregivers , that can     be replayed in cell phones for extended learning, will increase their adherence to     Medications after stroke and improve the control of blood pressure, elevated cholesterol and     glucose in the participants getting cell phone based educational videos.   "
82793|NCT02202317|"     This is a prospective non-blinded case series involving the acquisition of a pair production     PET/CT as soon as possible after an already performed Y-90 Sirspheres treatment of hepatic     malignancy. It will be performed in addition to the standard Brehmsstralung SPECT scan. The     sequence of the two scans in each case (PET/CT vs SPECT) will be determined by availability     of the scanners at the time. However, it is intended that both be acquired on the day of the     Y-90 treatment.      The length of subject participation will be one year.      The measures used will be mostly qualitative in nature, and will include:        -  Degree of correlation with expected vs. achieved tumor coverage by the treatment        -  Degree of correlation between treatment distribution depicted by Brehmsstrahlung scans          vs. the Internal Pair Production PET/CT scans, to include an assessment/comparison of          the precision of anatomic localization achieved by the two modalities.        -  Determination of Tumor/Background ratios, and correlating with planned dose        -  Detection of non-target embolization, where applicable, and qualitative comparison          between the two modalities as to the conspicuity of the abnormality      Qualitative methods will be used by the analysis of the obtained PET/CT images and comparing     them to the Brehmsstralung SPECT images as previously described.      Tumor to background ratios will be generated and used as a metric for correlation with     planned/administered dose and also with CT and/or FDG PET scans pre or post treatment, if     available. For CT, the RECIST criteria will be used to calculate volumes of necrosis, would     be used for the correlation. For FDG PET scans, SUV would be used for correlation.   "
82794|NCT02202304|"     Cervitec, a chlorhexidine based varnished has been proven to reduce caries risk in younger     populations. This study wants to investigate if the use of this product would reduce the risk     of losing abutment teeth on patients that are wearing partial dentures as the literature has     proven that these teeth are more prone to caries and periodontal disease.      The primary objectives of this research project are to:        1. Assess if the topical application of CHX/thymol varnish every three months on partial          denture abutment teeth results in a clinicallu significant decrease in any loss of          attachment compared to no application, and        2. Assess if the topical application of CHX/thymol vanirhs every three months on partial          denture abutment teeth results in a clinically significant decrease in carious lesion          development or progression compared to no application.      The secondary objectives of this research project are to:      1. Assess of the topical application of CHX/thymol varnish every three months on partial     denture abutment teeth compared to no application results in a clinically significant     difference in:        1. Bleeding on probing (BoP).        2. Plaque formation.        3. Periodontal pocket depths.        4. Microbial composition and GCF cytokine profile of the sub gingival environment.        5. The patients self perception of oral health.   "
82795|NCT02202291|"     Vasospasm is a transient contraction causing a decrease in caliber of a vessel and thus a     decrease in vascularization in a vascular territory leading to suffering of tissue in the     sector concerned. Vasospasm-related diseases have different clinical presentations such as     migraine, spastic angina, hypertension related to vasospasm or primary Raynaud's phenomenon     (RP). These diseases have few therapeutic methods due to poorly understood pathophysiology.     For migraine and angina, the vascular exploration is problematic unlike for primary Raynaud's     phenomenon (RP).      Primary Raynaud's phenomenon (RP) is a common peripheral vascular disease to cold with an     estimated prevalence between 5-9 % of the general population. It is the expression of an     extreme vasospasm microcirculation of the extremities linked to hypersensitivity to cold and     that is clinically expressed by the occurrence of syncope stages where the fingers are     anesthetized and white, followed by a stage with hyperemic restaining .      The objective of our study is to identify new metabolic pathways involved in vasospasm in     order to consider new specific treatments, currently lacking.      The identification of these pathways will be made by the detection of genetic abnormalities     causing vasospasm in Raynaud's phenomenon. This disease is a perfectly appropriate model to     study vasospasm by its high frequency in the population, its hereditary nature and simple     diagnosis. The powerful current genetic strategies will be applied to this model (exome     sequencing combined to family connection analysis).   "
82796|NCT02202278|"     The aim of the study is to determine serum oxidative stress status by ischemia modified     albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative     stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control     group. We also aim to reveal the association between serum levels of these factors and oocyte     quality.   "
82797|NCT02202265|"     Background: Cardiovascular diseases are the major health problem worldwide and the     understanding of genetic contributions on the development of cardiovascular diseases is     increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of     LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is correlated     with increased consumption of total fat. The transcription factor STAT3 is released during     the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3 gene is     associated with abdominal obesity and higher intake of saturated fat. Studies have been shown     the benefits of the Mediterranean diet in secondary prevention of cardiovascular disease and     these dietary patterns have been often studied with nutrigenetic approach; these studies,     however, are often limited to European populations, making it difficult to generalize to     different populations.      Hypothesis: Different dietary approaches may similarly influence in modifying metabolic,     inflammatory and anthropometric profile, especially among patients with coronary arterial     disease (CAD). The genetic interaction with environmental factors such as the nutrient     intake, and the prescription of a different diet according to individual genotype, could     influence the development and/or the treatment of cardiovascular diseases.      Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and     anthropometric profile in patients with CAD and possible interactions with polymorphisms in     CD36 and STAT3 genes.   "
82833|NCT02201797|"     Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced)     and DWI MRI can provide valuable information regarding tumor biology and response to     treatment through various parameters. Validating stability of these parameters will further     establish robustness and reliability of these promising biomarkers.   "
82834|NCT02201784|"     The purpose of this study is to compare the effects of two intrathecally administered     drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia   "
82798|NCT02202252|"     It is not known whether decreasing the number of drains used decreases patients' discomfort     and duration of hospital stay without increasing seroma formation after mastectomies.      Hypothesis. Use of one drain increases patient comfort without increasing seroma formation     after modified radical mastectomy (MRM) as compared to double drains.      Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and     Research Hospital will be randomised into single versus double drains groups. A negative     pressure drain will be inserted below the lower flap directing to the axilla in the single     drain group or two similar drains will be inserted into the axilla and below the lower flap     in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma     is defined as fluid accumulation below the flaps and will be examined daily after the     operation. One day after removal of the drains seroma under the flaps and in the axilla will     be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of     the patients duration of the hospital stay, duration of the drains in place, total drain     output in the first three days after the operation and the need and frequency of aspirations     due to seroma formation will be recorded. Patient comfort was measured with a comfort scale     between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep     disturbances caused by the drains, The duration of the longer staying drain in the double     drain group will be recorded for the duration of the drain in place parameter.   "
82799|NCT02202239|"     To explore the effect of induction and maintenance of anesthesia with etomidate on     hemodynamics and oxidative stress in diabetic patients.   "
82800|NCT02202226|"     The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after     repeated oral dosing to patients with schizophrenia.   "
82801|NCT02202213|"     The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in     patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone     or as added treatment to risperidone).   "
82802|NCT02202200|"     An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD)     evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering     metastatic melanoma with BR.      The main objective is to establish the Maximum Tolerated Dose (MTD) of PD-0332991 when added     to standard vemurafenib therapy (960 mg BID). The estimated MTD is defined as the dose of     PD-0332991 combined with vemurafenib that will be associated with a prespecified proportion     of patients experiencing a Dose-Limiting Toxicity (DLT), ie, 1/3.   "
82803|NCT02202187|"     GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of     antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive     including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens     associated with respiratory tract, skin and soft tissue infections including isolates     resistant to existing classes of antimicrobials. This is a First Time in Human (FTIH) study     to assess the safety, tolerability, and pharmacokinetics of single oral doses of GSK2140944     in healthy volunteers. This study will be a single-blind, randomized, placebo-controlled,     dose-rising study in healthy subjects. The proposed single doses will range from 100 mg to     3000 mg.   "
82804|NCT02202174|"     This purpose of this study is to determine the effectiveness, risk factors, and complications     associated with use of supraglottic airway devices for primary airway maintenance during     routine anesthesia in children.   "
82805|NCT02202161|"     This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for     14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female     subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this     study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin     850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg,     20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID.     Subjects will return for a follow-up visit 7-10 days after discharge.   "
82806|NCT02202148|"     This study is complementary to the main study Brain Derived Neurotrophic Factor Serum Levels     Evolution During the Six Months After Alcohol Withdrawal  NCT01491347.      Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption.     It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to     depend on alcohol consumption in alcohol dependent patient, more precisely on the time after     the last alcohol consumption. This is very few documented after alcohol withdrawal, and has     never been explored during several months after withdrawal as a function of alcohol     consumption and abstinence.      Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis     and also liver function.      We propose here to analyse the serum BDNF levels variations after withdrawal according to     liver stiffness levels and alcohol consumption status.      We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included     in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28     and months 2, 4, and 6.   "
82807|NCT02202135|"     The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin     plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue     infections.   "
82808|NCT02202122|"     Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the     prognosis of postoperative mortality after femoral neck fracture.   "
82809|NCT02202109|"     The study will test the significance of community health worker (CHW) participation by     comparing self-sampling provided by a community health worker and self-sampling provided by     mail. The study will enroll 700 participants in communities that lack access to medical care     in South Florida.   "
82810|NCT02202096|"     The primary hypothesis is that a comprehensive transitional care program based on the premise     of a patient-centered medical home versus routine care reduces emergency room visits and     hospital readmissions without increasing costs among cancer patients undergoing surgery at a     large safety-net hospital.   "
82811|NCT02202083|"     Currently, the study about intervention on the induced abortion at trimester is so little.     So, the investigators want to compare the safety and effectiveness of different induced     labor.   "
83236|NCT02196506|"     The purpose of this study is to assess the tolerability, safety, and efficacy of     brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD     with and without anxious distress   "
82812|NCT02202070|"     Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated     with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter     muscle hyperactivity and spasm      This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain     disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint     disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units     Botox in temporalis and masseter muscles in 32 patients with 6 months follow up.      The objective of the proposed study will be to establish the safety and efficacy of botox in     treating TMD associated with bruxism. By the time patients reach the specialists office, most     have failed maximal conservative therapies, including non-chew diet, night guard, oral     analgesics, muscle relaxants, physical therapy, and a portion have even undergone more     invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty     surgeries with limited improvement or recurrence. Primary outcome of the study will be 50%     reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase     in maximal inter-incisal opening (MIO). The investigators look forward to working with you on     the proposed study   "
82813|NCT02202057|"     The purpose of this study is to determine whether people with Parkinson's disease (PD)     experience reduced perception of respiratory resistive loads versus healthy adults in the     same age group. Further, the study will determine whether people with PD and trouble     swallowing experience even more reduction of their perception of a respiratory resistive     load.   "
82814|NCT02202044|"     The primary objective of the study is to assess the bladder cancer recurrence free rate,     according to a phase II pilot study, of intravesical instillation of sequential BCG and     EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure     is disease recurrence rate. Follow up will continue up to 5 years.      For sample size determination, disease recurrence rate will be compared with literature data     of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).   "
82815|NCT02202031|"     We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation     therapies in 160 ambulatory women who report an average of at least 3 urgency-associated     voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to:     1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least     15 minutes/day at home using a portable guided-breathing device; or 2) use an     identical-appearing device that plays relaxing music while monitoring their spontaneous     breathing pattern. We do not know if either of the two types of relaxation therapies is     effective in treating OAB. All women will also receive a usual care pamphlet providing basic     information about other traditional self-management strategies for OAB.   "
82816|NCT02202018|"     Patients with severe kidney failure require dialysis or transplantation to survive. For those     in whom a transplant is not an option, there are two main dialysis options: hemodialysis     (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal     and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion     of home-based therapies varying between 10 and 40% across centres. Studies show that the low     use of home dialysis is due to a variety of factors, though patient and provider awareness     and knowledge of home dialysis are major factors. In this cluster randomized trial, the     investigators will determine whether a standardized modality education program directed at     patients, in combination with a provider-directed intervention, can increase the use of home     dialysis in incident dialysis patients in Canada.   "
82817|NCT02202005|"     The objective of this steady state pivotal study is to compare the rate and extent of     absorption and to evaluate Bioequivalence of test drug compared to the approved reference     product in HIV infected individuals   "
82818|NCT02201992|"     This randomized phase III trial studies how well crizotinib works and compares it to placebo     in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by     surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations,     or changes, in ALK can make it very active and important for tumor cell growth and     progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from     working. Crizotinib may be an effective treatment for patients with non-small cell lung     cancer and an ALK fusion mutation.   "
82819|NCT02201979|"     Breast lift surgery performed in combination with breast implants is a common cosmetic     operation. However, there have been concerns regarding the safety of this treatment     combination. Some investigators are concerned that an implant may increase the risk of     complications, including loss of circulation to the nipple and areola. This study was     undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent     imaging and to determine whether a breast implant compromises blood supply to the nipple and     areola.   "
82820|NCT02201966|"     Low back pain is a common condition in children who perform gymnastics. Commonly, the injury     is not the result of a specific injury, but is a stress injury to the lumbar spine. Regional     interdependence is a theory that suggests when adjacent joints and muscles are not working     properly increased stress is placed on a particular joint. This theory would suggest that if     a patient did not have enough hip extension to perform a back bend increased motion would     occur in the lumbar spine allowing the gymnast to complete the technique. Currently, no     research links impairments in other joints to low back pain in gymnasts.      This is a cross sectional study assessing the relationship between gymnast with back pain and     flexibility and strength of the shoulder and hip joints. Investigators will travel to a local     gymnastics training centers and assess the gymnasts' strength and flexibility of the the hips     and shoulders. The gymnast will also fill our a questionnaire assessing if they have had back     pain in the past month and how much has it limited their ability to participate in     gymnastics. Investigators will be blinded to the results of this survey.      The goal of this research study is to see if there are any link between strength and     flexibility of the hips, and shoulders and gymnasts with low back pain. The investigators     hypothesize that gymnasts who demonstrates impairments in strength and flexibility of the     hips, or shoulders will be more likely to have complaints of low back pain.   "
82821|NCT02201953|"     The primary objectives of this study are to compare the efficacy of treatment with     sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of     sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability     of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV)     infection.   "
82823|NCT02201927|"     Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients     suffering right posterior parietal lesions fail to update their own position after a body     rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal     cortex and reduces symptoms of spatial neglect, another disability frequently encountered     after right posterior parietal lesion. The aims of this study are to confirm posterior     parietal involvement in automatic updating of body-centered spatial relationships and to     evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups     of adults are compared before and during galvanic vestibular stimulation on a pointing task:     a healthy control group, a brain-injured control group with stroke lesions sparing right     posterior parietal cortex and a group of stroke patients with right posterior parietal     lesions.   "
82824|NCT02201914|"     Poor ovarian response to stimulation in IVF cycles is a challenging and frustrating     condition, due to its poor prognosis in terms of chances of pregnancy and live births.     Various ovarian stimulation regimens have been tried to overcome these obstacles. A simple     approach is increase the dose of the gonadotropin administration, but the results in terms of     pregnancy rate are very low Another commonly used stimulation regimen is the microdose GnRH     agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that     follows the agonist administration in the early follicular phase and subsequently prevents a     premature LH surge, with fewer cycle cancellations. However, their application in poor     responders, even if in small doses and for a limited period, has been questioned as they may     cause oversuppression of ovarian function, leading to a prolonged cycle and increased     treatment costs without improving the outcomes.      Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing     a premature LH surge and allow for a more natural recruitment of follicles in the follicular     phase in a non-suppressed ovary, offering a potential alternative in the treatment of these     patients. However, randomized studies evaluating the efficacy of this regimen in poor     responders did not show any improvements in pregnancy rates. Current approach have included     the addition of oral agents such us clomiphene citrate (CC) to gonadotropins. Some authors     have investigated the role of CC in addition to low dose of gonadotropins in mild stimulation     regimen, demonstrating that, despite a small number of retrieved oocytes, good quality     embryos were produced with a subsequent improvement in the fertilization rate, clinical     pregnancy rate and live birth rate. The only study that evaluate the efficacy of CC in     addition to high doses of gonadotropins in poor responders showed improving in number of     retrieved oocytes, transferred embryos and biochemical pregnancy; however, clinical pregnancy     rate and live birth rate remained low and showed no measurable increase.      The aim of this study was to compare the efficacy of the CC as an adjunctive to a high dose     of gonadotropins in cycles with antagonist protocols with the microdose GnRH agonist and     flexible antagonist protocols in women who responded poorly to ovarian stimulation, to     determine whether this protocol may improve IVF outcomes, offering a valid alternative in     poor responder patients treatment.   "
82825|NCT02201901|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin     (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus     (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.   "
82826|NCT02201888|"     Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence     suggests has consequences for functional adaptation and which cause difficulties in social     re-integration after hospitalization. The investigators propose a large scale, multicentric     study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed     at answering outstanding questions concerning the effectiveness of cognitive estimulation     therapy for schizophrenic cognitive impairment. Specifically, the study will examine a)     issues related to the size of the effect compared to treatment as usual and compared to a     control intervention; b) generalizability of improvement to cognitive function and social     cognition in daily life; and c) the durability of therapeutic gains after the end of     treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three     treatment conditions: a computer- assisted cognitive estimulation program (n=64),     non-structured time on computer (n=64) and treatment as usual (n=64). A battery of     neurocognitive tests of memory and executive function, including 'ecologically valid'     measures, will be administered by blind evaluators at baseline, after 6 months of cognitive     estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will     be also be assessed at baseline, after the treatment and at follow-up.   "
82827|NCT02201875|"     We made a fortuitous observation of periodic breathing in a healthy subject coming to our     outpatient mountain medicine consultation at Avicenne hospital in Bobigny (France). During     this consultation, subjects perform a hypoxia exercise test, which allows a good prediction     of their risk factors for severe high altitude illnesses. Surprisingly, breath-by-breath     recording of the ventilation signal showed a periodic breathing pattern, which increased when     the subject started to exercise in hypoxic conditions and was maintained during normoxic     exercise.      Therefore, our objective was to confirm this observation in a retrospective study led in 82     subjects who passed this test. We tested the hypothesis that subjects with a brisk     ventilatory response to hypoxia might show a more pronounced periodic pattern of ventilation,     due to a higher gain of the chemoreceptor feedback loop. Then, our objective is to     investigate the mechanisms involved in the periodic pattern in healthy subjects, as a     function of exercise intensity, altitude intensity, role of peripheral and central     chemoreceptors to O2 and CO2. Finally, we want to investigate the possible role of this     ventilatory instability in patients with obstructive or central apneas.   "
82828|NCT02201862|"     This study is being conducted to provide clinically annotated samples to support continued     improvements in the Ariosa Test content, methodology, specimen processing and quality     control.   "
82829|NCT02201849|"     This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a     monomethyl fumerate (MMF) molecule.   "
82830|NCT02201836|"     The onset of asthma is particularly frightening for children. When the symptoms of asthma     decrease, children and parents forget about the maintenance and control of breath and lung     volume. Because adherence is so poor, asthma is known as the emergency room illness. The     playing of a wind instrument is a unique way to provide a creative means for children and     teens to understand both the impact of diaphramatic breathing and their ability to control it     as well. This study builds upon the evidence, though sparse, that suggest that the blowing of     a wind instrument with clinical music therapy intervention strengthens the muscles of     breathing and fortifies the incentive toward attending to the daily symptoms and general     management of asthma.   "
82831|NCT02201823|"     Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new     drug, ABTL0812, that will be administered orally daily to patients with advanced solid     tumors.   "
82832|NCT02201810|"     This study is a randomized clinical trial designed to measure the effectiveness of three QL     interventions for smokers who failed to quit an initial smoking cessation intervention, but     remain motivated to quit smoking.   "
85081|NCT02172378|"     Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function     and static lung volumes, correlate this effect with dyspnoea in COPD patients.   "
82835|NCT02201771|"     The study population will include all patients undergoing elective CABG. Consent and     randomization will occur before surgery. Total 500 patients undergoing elective CABG will be     randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this     open-label study. All the enrolled patients will stop oral antiplatelet drugs according to     local protocol before the surgery. Within the first 24 hours after surgery, study medication     should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs     by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving     ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs     by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients     will undergo a multislice computed tomography angiography to assess vein graft patency.      This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as     compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of     vein graft patency.   "
82836|NCT02201758|"     This study proposes to examine the effect of diet as a modifiable risk factor among patients     with ulcerative colitis (UC). Flax seeds contain many bioactive constituents which have     anti-oxidative, anti-inflammatory, and anti-carcinogenic effects. These bioactive compounds     represent novel classes of pharmacologically active compounds which may represent new options     to treat chronic disease of the gastrointestinal tract. Participants with mild to moderately     severe UC will supplement their current medications with flaxseed lignan-enriched complex     (FLC). This is a 12 week double blind placebo controlled study with assessment throughout.     Stool and blood samples (biomarkers) as well as bowel assessment via sigmoidoscopy will be     evaluated before and after the intervention. The treatment arm consists of 300 mg FLC taken     orally twice daily.   "
82837|NCT02201732|"     The purpose of this study of is to compare subsequent fertility rates between hysteroscopy     and aspirative curettage in the surgical treatment of incomplete spontaneous abortion   "
82838|NCT02201719|"     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of     the uterus. It affects about 15-20% of the female population.      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation     (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been     correlated with adenomyosis.      Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as     local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune     and mechanical factors are also hypothesized.      Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic     measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin     releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation     have been tried, but studies are few in number, retrospective, and have small sample sizes.      Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of     adenomyosis remains still unclear, there are not many satisfying treatment options and     diagnostics include mostly magnetic resonance imaging (MRI) and histology.      The investigators designed a series of 3 studies with a broad approach in understanding     adenomyosis. This is part 1.      NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic     of adenomyosis   "
82839|NCT02201706|"     Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a     complex retinal detachment with poor prognosis.      In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation     retinectomy to reattach the retina. Here the investigators aimed to explore the safety and     efficacy of this new surgical approach   "
82840|NCT02201693|"     The purpose of this study is to compare the rate of first relapse at 12 months between     maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily     calories) and maintenance therapy with supplementary enteral nutritional support (25% daily     calories).   "
82841|NCT02201680|"     1. Appreciation of preoperative anxiety in children is important for the anesthesiologist.        2. Several factors defined to effect the anxiety levels preoperatively in children such as          , age, previous medical encounters , education level and parental anxiety. 3. This          information was tested for Turkish children during the preoperative anesthetic          evaluation.   "
82842|NCT02201667|"     The goal of acute coronary syndrome (ACS) therapy is to successfully restore both epicardial     blood flow and myocardial perfusion. Percutaneous coronary intervention (PCI) has been     documented as being the most effective method for restoration of epicardial blood flow.     However, epicardial blood flow does not necessarily equate to myocardial perfusion.     Clopidogrel binds irreversibly to platelet P 2 Y 12 receptors to inhibit platelet     aggregation, with main limitations of slow onset, prevention of recovery of platelet     functions, and interindividual variability. Clinical pharmacology and early dose-finding     studies suggested a faster onset and greater and more consistent inhibition of platelet     aggregation (IPA) with ticagrelor compared with clopidogrel. Two currently main methods of     angiographic assessment of myocardial perfusion includes thrombolysis in myocardial     infarction(TIMI) myocardial perfusion grading (TMPG) and myocardial blush grading (MBG).     These established myocardial perfusion parameters have been widely used in various important     trials and are reported to be highly useful in predicting clinical outcomes. However, visual     assessment of these methods is categorical, subjective, and operator dependent of contrast in     the myocardium using cine-angiographic frame-counting, was developed by the investigators'     center to quantify myocardial tissue- level perfusion and was proved to be a predictive value     on clinical prognosis.      Thus, the investigators aim to initiate an open-label study evaluating the acute efficacy of     treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed by     Myocardial Perfusion Frame Count(TMPFC) and magnetic resonance imaging (MRI) in patients with     high-risk non-ST elevation acute coronary syndrome (NSTE-ACS) undergoing early percutaneous     coronary intervention (PCI) .      The investigators hypothesize that compared with clopidogrel, ticagrelor can significantly     improve myocardial perfusion assessed by Myocardial Perfusion Frame Count(TMPFC) in high-risk     non-ST elevation acute coronary syndrome (NSTE-ACS) patients undergoing early percutaneous     coronary intervention (PCI), without additional increased major bleeding.   "
82843|NCT02201654|"     This research study compares two ways to biopsy lymph nodes in the chest using endobronchial     ultrasound-guided transbronchial needle aspiration (EBUS-TNBA). During a EBUS-TBNA     procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted     through the mouth into the large airways of the chest, allowing us to see (via ultrasound)     and biopsy the lymph nodes in the chest.      The purpose of this research study is to determine if the EBUS-TBNA procedure can be made     simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an     inner stylet that runs through the middle of the needle. Because many other biopsy needles     (such as the needles used in breast biopsy and different types of lung biopsy needles) do not     use an inner stylet, the investigators do not think the use of a stylet is necessary. If this     step can be safely eliminated without decreasing the effectiveness of the procedure, this     could shorten the procedure (saving time). This study is deigned to formally test the     hypothesis that a stylet is not necessary in EBUS-TBNA.   "
82844|NCT02201641|"     This study aims to investigate the tooth nerve response to a recently introduced therapeutic     filling material (calcium silicate cement) called Biodentine and to assess the quality of the     overlying filling compared to another material (glass ionomer cement) called Fuji IX used     more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays     compared to conventional periapical x-rays in detecting lesions around these teeth.   "
82845|NCT02201628|"     Children lose heat under general anaesthesia, thus temperature is routinely monitored during     anaesthesia for all but the shortest cases, and active warming can be used to prevent     hypothermia and its resulting complications. Temperature can be measured at several sites     dependent on the type of surgery and patient factors. Previously a temperature probe has been     sited in the lower third of the oesophagus (swallowing tube) but it is difficult to     accurately place this without an X-Ray. Consequently it is more common to use a temperature     probe placed in the nasopharynx (where the nose and throat meet), when the child is     anaesthetised.      However the investigators do not know if the temperature in the nasopharynx correlates well     with the real core temperature or not.This prospective, unblinded, agreement study will seek     to find an agreement of 2 methods to measure temperature in children undergoing general     anaesthesia with a breathing tube that has a leak.   "
82846|NCT02201615|"     Objective To examine the effects of perineal massage applied during the action of birth on     the frequency of episiotomy procedures, perineal tearing and the duration of the second stage     of birth.      Methods The present study was a randomized controlled experimental. Women (284 women) were     informed on the study and provided their written consent. 10-minute perineal massage with     glycerine was applied to the women in the test group for 4 times during the first stage and 1     time in the second stage of birth. The women in the control group received the routine care     procedure at the clinic.      Results According to the study findings, 31% of the women in the test group and 69.7% of the     women in the control group were made subject to episiotomy (p<0.05). In the test and control     group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p>0.05). The average     duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the     control group (p<0.05).      Conclusion The study results indicate that perineal massage applied during the action of     birth decreased the rate of episiotomy procedure and shortened the duration of the second     stage of birth.   "
82847|NCT02201602|"     Gliclazide has greater glucose lowering efficacy than glibenclamide among type 2 diabetes     mellitus patients with minor haplotype (K23/A1369) at the KCNJ11/ABCC gene locations.   "
82848|NCT02201589|"     The purpose of this study is to investigate the outcome of patients with pathologies of the     ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from     the heart) including type A aortic dissection, retrograde type A aortic dissection,     intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular     (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician     Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a     condition where blood passes through the inner lining or between the layers of the blood     vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type     A aortic dissection is a condition where the dissection or tear in the ascending aorta starts     from the descending aorta; an intramural hematoma is a collection of clotted blood within the     aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is     a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and     rupture causing injury or death. The plan for these patients is to repair the ascending     thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery     System. The Valiant Captivia has been evaluated worldwide and used extensively in patients     with type B (descending) thoracic aortic dissection. Since the dissections in the ascending     aortas mirror that of the descending aorta, it is expected that this stent graft will deliver     similar performance and endurance in patients with type A aortic dissection. The     investigators expect to reroute the blood to the true lumen (the inner space within the blood     vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent     graft is a stent frame made from Nitinol wire and covered with an expandable material made of     a polyester material. This new study will determine how well the device works to treat     dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending     thoracic aorta.   "
82849|NCT02201576|"     The purpose of the study is to assess the efficacy of bortezomib, in association with     steroids, plasma exchange, and polyclonal intravenous immunoglobulins, in the treatment of     chronic antibody mediated rejection due to donor specific anti-HLA antibodies, in kidney     transplant recipients   "
82850|NCT02201563|"     Stereotactic radiosurgery (SRS) is a well-established treatment for patients with metastatic     brain tumors. Although SRS has a very high tumor growth control these interventions are     associated with adverse radiation effects (ARE) in approximately 15 % of patients. The     traditional approach, and still a mainstay, is the administration of a course of high dose     anti-inflammatory corticosteroids. Currently there are no other effective oral     neuroprotective agents in clinical practice which can improve outcomes of patients with ARE     after radiosurgery for brain metastases.      Minocycline, an antibiotic with a favorable adverse effect profile and pharmacokinetics, has     been shown to have neuroprotective properties in experimental models of a variety of     neurological diseases, as well as in human clinical trials. The investigators propose a     single arm clinical trial, to evaluate the safety and feasibility of minocycline in improving     ARE. This study will recruit 15 patients who will be treated with minocycline (100mg BID) for     3 months. This clinical trial has the potential to prove that minocycline therapy is safe in     this patient population. In addition, positive results will provide preliminary evidence for     its use in an array of radiosurgical indications.   "
82851|NCT02201550|"     The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on     the immune system i.e on the regulation of immune cells important in diseases such as obesity     and diabetes.      The hypotheses are:        -  Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in          the blood        -  Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood        -  Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine          profile in the blood   "
82852|NCT02201537|"     The hypothesis of our study is that a correlation exists between the couple ultrasound     elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of     fibrosis estimated in a semi-quantitative way in 4 stages (0; 25 %; 25-50 %; > 50 %), as     elastography alone did not allow to differentiate moderated fibrosis at 3 months in our     feasibility study.   "
82853|NCT02201524|"     Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in     patients with moderate to severe psoriasis. The study will include three PF-04965842 groups     (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period     will be 4 weeks in duration and will be followed up by a 4 week follow up period.   "
85113|NCT02171962|"     The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for     treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient     population.   "
82854|NCT02201511|"     The study is designed to understand the blood concetration of PF-06412562 and its metabolite,     PF-06663872, following a single oral dose of a modified release formulation. The study will     include two doses of the PF-06412562 modified release formulation to understand the     proportionality. Effect of food on absorption of PF-06412562 from the modified release     formulation will also be investigated in this study.   "
82855|NCT02201498|"     This is a RCT that will compare the clinical and radiographic success of pulpotomies on     primary molars between the traditional technique (Formocresol/ZOE) and the new technique with     Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.   "
82857|NCT02201472|"     MRI & MRE in infants   "
82858|NCT02201459|"     This is a phase III trial comparing, for newly diagnosed chronic phase CML patients,     nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa 2     a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for     a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the     primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is     the rate patients obtaining MR4.5 will be measured at this time point.   "
82859|NCT02201446|"     Efforts to identify circulating factors that predict severity of acute lung injury/acute     respiratory distress syndrome（ALI/ARDS） patients is unrevealing. The primary purpose of this     study is to verify our hypothesis that soluble CD74 might be a potential novel ALI/ARDS     biomarker.   "
82860|NCT02201433|"     Breastfeeding is recommended for preterm infants. Development of breastfeeding is an     important issue, requiring the involvement of medical and paramedical staff in neonatal     units. There are few data concerning the fathers of preterm infants. However, the role of the     father is identified in the literature as a key factor in the initiation and continuation of     breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not     identified but may be related to the father being in close and constant contact with the     medical and paramedical staff. In fact, fathers are often first in contact with caregivers.     They can be invested in the implementation of nursing care, skin to skin, as well as being     asked to support the development of their child in the service and at home.      The aims of this study are to:        -  Analyze the beliefs, social representations and the experience of the fathers of          premature infants hospitalized in intensive care unit concerning breastfeeding.        -  Analyze the factors facilitating and inhibiting the initiation and continuation of          breastfeeding.        -  Consider strategies of care and support that can be used for the families of premature          infants and of children born at term.        -  Explore the expectations of medical staff with regards to the management of children and          families, their practices, identify the role attributed to the father.        -  Initiate and facilitate reflexivity of medical and paramedical staff about their          respective practices   "
82861|NCT02201420|"     The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc     99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This     is a single center, open-label, within-subject study.   "
82863|NCT02201394|"     ACS patients treated with antiplatelet drugs who require CABG surgery have to wait 5-7 days     for the effects of the drugs to wean off. This treatment-devoid period leaves the patient     vulnerable, therefore any means to shorten this period could be useful. The present study     aims to investigate the possibility of reversing the antiplatelet effects of ticagrelor with     the help of fresh donor platelets. Fresh platelets will be added to blood samples of treated     patients in varying concentrations at specific timepoints to determine the time and amount of     fresh platelets needed to normalize platelet reactivity in the treated samples.   "
82864|NCT02201381|"     The purpose of this study is to determine the effectiveness of a regimen of selected     metabolic treatments for patients with cancer in a real world setting and to conduct     exploratory analysis on the relationship between the degree of response and changes in     biochemical markers (such as glucose and lipid levels).   "
82865|NCT02201368|"     The purpose of this study is to determine if administration Triheptanoin is an effective     treatment for defects of the long-chain fatty acid beta-oxidation in young adults or adults.     Period of treatment and follow-up will be 16 months.   "
82904|NCT02200861|"     In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts     were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep     sedation. All patients dates will evaluate from their patient file retrospectively from 2011     to 2014.   "
82907|NCT02200822|"     The primary objective of this study is to demonstrate that in patients with     recuperated/normalized left ventricular function, defined as an ejection fraction (EF) ≥ 50%,     after implantation of cardiac resynchronization therapy, device treatment is sufficient and     neurohumoral blocker therapy can safely be withdrawn   "
82866|NCT02201355|"     Primary Objectives:      To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx,     hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks     using reduced volume IMRT      Secondary Objectives:      To describe the adverse events associated with hypofractionated, reduced volume cisplatin     chemoradiation.      To estimate response rates and progression-free survival rates of hypofractionated, reduced     volume cisplatin chemoradiation.      To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation.      If patients can safely be treated in three weeks rather than six weeks, such a schedule would     provide a much more convenient alternative for patients and result in a significant reduction     in the health care resources currently expended on cure of these patients.   "
82867|NCT02201342|"     To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan     physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic     measures of exercise capacity, ventricular performance, and vascular function.   "
82868|NCT02201329|"     To identify the maximum tolerated dose or recommended dose for further development of     volasertib in combination with azacitidine in Japanese patients with myelodysplastic     syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability,     pharmacokinetics and the preliminary efficacy of this combination.   "
84547|NCT02179372|"     The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin     levels in IBD patients in clinical remission. During the study fecal calprotectin levels will     be measured every 3 months and clinical flares will be registered.   "
82869|NCT02201316|"     This study aims to determine the relative bioavailability of two candidate formulations of     mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate 5mg)     from Dainippon Pharmaceutical Company in healthy adult subjects. This will be an open-label,     randomised, single dose, three-way crossover, six sequence study. Subjects will receive a     single oral dose separated by at least 7 days and no greater than 14 days washout period.     This study is required to select a candidate mosapride citrate (GR107719B) formulation for     further development and provide data to allow the design of a future pivotal bioequivalence     study. The candidate formulations will be compared with the innovator GASMOTIN. GASMOTIN is a     trademark of Dainippon Sumitomo Pharmaceutical Company.   "
82870|NCT02201303|"     This study is to determine danirixin (GSK1325756) concentrations required to inhibit     neutrophil activation in blood obtained from Respiratory Syncytial Virus (RSV)-infected     children <2 years and healthy adults. The study will evaluate differences in neutrophil     activation between RSV-infected children <2 years and healthy adults with escalating     concentrations of Chemokine (C-X-C motif) Ligand 1 (CXCL1) and danirixin to determine if     RSV-infected children and adult neutrophils are similarly activated by CXCL1 and inhibited by     danirixin. This study will guide dose prediction to inhibit specific percentages of     neutrophils in future pediatric RSV-infection studies. This single-center, in vitro study     will consist of 2 parts. Approximately 24 subjects will be enrolled, including 12 healthy     adults and 12 RSV-infected children <2 years.   "
82871|NCT02201290|"     This is an open-label Phase III extension study to evaluate the long-term safety of     eltrombopag in pediatric patients with chronic ITP who previously participated in study     TRA115450. This study will allow dosing of eltrombopag at an individualized dose for each     subject based upon platelet count. The starting dose will be based on the subject's dose at     the end of the TRA115450 study. The maximum dose will be 75 mg daily.   "
82872|NCT02201277|"     This research study is a prospective randomized trial evaluating the relative safety of two     inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous     deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All     eligible patients will have been ordered to have a IVC filter placed by their primary medical     team and filters will be placed in these patients whether or not they wish to participate in     this trial as part of standard of care. The investigators will follow up with patients 30     days after IVC filter placement and ask them to come back for filter removal if medically     appropriate. If removal is not medically appropriate in 30 days, the investigators will     attempt to schedule removal every 30 days after initial placement.      Primary outcome measures will be IVC filter complications such as filter penetration through     the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots     formed within the filter. All of these are reported complications of all IVC filters.      The research also aims to improve the standard of care for IVC filter patient follow up as     the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon     as it is safe to do so.      Hypothesis:      The investigators hypothesize that there is no significant difference in efficacy and     complication rate between the Option and the Denali filter.   "
82873|NCT02201264|"     The proposed study is a registry of patients treated with primary angioplasty for acute     myocardial infarction.      The aim of this registry is to define the outcomes of patients treated for acute, ST-segment     myocardial infarction (STEMI) at community hospitals without on-site cardiac surgery programs     that have completed the C-PORT Primary Angioplasty Development program. The primary medical     outcome for the registry is the combined incidence of death, recurrent non-fatal myocardial     infarction and stroke.   "
82874|NCT02201251|"     The purpose of this study is to evaluate the safety of topiramate monotherapy compared with     levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or     recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone     mineralization, and kidney stone formation in children aged 2 to 15 years.   "
82875|NCT02201238|"     This research study is being conducted to characterize the pharmacokinetic properties of a     new topical medication (MFC51123) that contains two active ingredients (diclofenac and     menthol) in two formulation packages. One formulation package is in the form of a gel in     aluminum tube and the other one in the form of a gel in roll-on applicator bottle.     Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel     and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol     gel has being developed to treat mild to moderate pain and inflammation, such as acute sport     injuries, sprains and strains. The rationale for conducting the study is to prove that     repeated topical treatment of the new diclofenac + menthol formulation in either of the two     packages does not result in unsafe systemic exposure.   "
82876|NCT02201225|"     This methodology study will evaluate the sensitivity in using sitting knee digital caliper to     measure changes in sitting knee length from over a 12-week study period amidst children in     the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are     receiving nutritional supplementation with micronutrients or without micronutrients.   "
82877|NCT02201212|"     In this research study, the investigators are evaluating the clinical benefit of everolimus     in cancer patients with inactivating TSC1 or TSC2 mutations or activating MTOR mutations.      This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug called everolimus to learn whether the drug works in treating a     specific cancer. Investigational means that the drug is being studied. It also means that     the FDA (the U.S. Food and Drug Administration) has not yet approved everolimus for your type     of cancer.      Everolimus is a drug that may stop cancer cells from growing by blocking an important factor     (mTOR) involved in the growth of cells. This drug has been used in treatment for other     cancers and is approved by the Food and Drug Administration for treatment of several types of     cancer, including renal cell carcinoma. Treatment with this drug has been associated with     responses in some patients whose cancers had mutations in TSC1 or TSC2. The investigators     think that patients whose tumors have mutations in TSC1 or TSC2 may have a good chance of     responding to treatment with drugs like everolimus.   "
82890|NCT02201043|"     1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the          treatment of active ankylosing spondylitis.        2. To explore dose-effect relationships of taking thalidomide tablets once daily in the          treatment of active ankylosing spondylitis, as well as selecting the appropriate dose          for the further larger scale clinical trials.   "
82878|NCT02201199|"     Primary Objective:      To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given     as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp     setting in subjects with type 1 diabetes.      Secondary Objectives:      To compare the metabolic activity characteristics of single doses of insulin glargine given     as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in     subjects with type 1 diabetes.      To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in     subjects with type 1 diabetes.   "
82879|NCT02201186|"     Patients with a bowel condition called ulcerative colitis have bowel surgery in which a     portion of their bowel is removed and the reconnected at the small bowel to the anus.     Sometimes, after the surgery, this connection part, the pouch, would be inflamed in a     condition called Acute Pouchitis. Physicians usually treat them by prescribing antibiotics;     however, some patients do not respond and need additional surgery. In this study, we will     test an alternative treatment for this complication by performing manuka honey enemas twice a     day for 30 days. This is a pilot study and ten patients will undergo enema treatment.   "
82880|NCT02201173|"     People with spinal cord injury (SCI) suffer from secondary health conditions that can result     in undue physical challenges and impact participation in activities in everyday life.     Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking     function in both the animal and humans by reactivating spinal circuits through intensive     therapy of muscles below the level of the injury. However, it is not known if LT also has     beneficial health effects and it is the focus of this study proposed to be undertaken at     Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal     networks to help recover balance and walking after SCI and may correspond with improvements     in health measures such as bladder function, breathing capacity, cholesterol and other     cardiac risk factors markers, and the ability to stand upright without drops in blood     pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body     weight supported in a harness, while walking overground and with the practice of key     exercises in the home and community. The emphasis is on loading the body through the legs     without braces and other devices except where necessary to function at home. The overall     objective of this study to capture and analyze health outcome data collected on 80 patients     enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is     funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people     with SCI. The purpose of this application is to leverage the NRN funding, that provides     support for LT and standardized outcome measures, to generate further knowledge on health     outcomes after LT for individuals with SCI. The proposed project will be accomplished through     the utilization of staff at each of the 6 NRN sites, lead by the study principal investigator     and the lead clinical research coordinator at SBU. They will ensure the data are captured     before and after LT in a standardized manner, at the correct time and entered into a     de-identified database. The study hypotheses are that after LT, compared to before, patients     with SCI will improve lipid profiles and insulin factors as measured by fasting blood tests;     respiratory function as measured by specialized but easy to use breathing equipment; and     blood pressure and heart rate during a maneuver to test for responses to abrupt changes in     posture. The relevance of this proposal is that it will help to determine if there is an     association between an intensive activity- based intervention (LT) and improvements in health     and will be used to form the basis for a larger randomized clinical trial and clinical     practice guidelines.   "
82881|NCT02201160|"     Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total     liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the     mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and     finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular     carcinoma. It is a common condition associated with a combination of disorders, namely     obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS)     was mainly studied in the adult population and very little in the paediatric population,     while 15 and 25% of obese children are affectés. The severity of histological disease appears     to be associated with the degree of obesity in children and particularly in the MetS. in     addition, epidemiological data indicate that the incidence of this disease is increasing in     children and positioning as the first NASH liver disease in North America. the revelation of     the factors associated with the occurrence of NASH is a first necessary step to understanding     this disorder worrying for the future of children and adolescents. In addition, clarification     of the mechanisms responsible for its development is essential if the investigators want to     consider targeted and effective treatments to slow the rat race of NASH, which stands out as     the supreme chronic liver accompanying the obesity and MetS. Finally, in view of growth and     puberty of children, it would be extremely beneficial to find nutritional avenues that would     avoid the side effects of chemical agents.   "
82882|NCT02201147|"     The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy     using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.   "
82883|NCT02201134|"     Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic     hypothermia of cardiac arrests resuscitated patients.   "
82884|NCT02201121|"     Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation     and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.   "
85114|NCT02171949|"     The purpose of this study is to evaluate the safety and efficacy of multiple infusions of     mononuclear bone marrow cells in patients with chronic liver diseases.   "
82886|NCT02201095|"     During anaesthesia for caesarean section it is common to lose heat and become hypothermic,     (<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid     and insulated from cold surfaces. There are also 2 types of machine available to actively     warm women;        1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air          pockets that have warm air blown into them continuously by a fan.        2. Conduction Warming Mattress - a thin mattress which covers the operating table and the          woman lies on top. The padded mattress has strips of material that heat up when          electricity passes through it, similar to a normal electric blanket.      We plan to carry out a randomised controlled trial to compare these 2 methods with the     current practice of no active warming.      The hypothesis for this study is that active warming women during elective caesarean section     prevents women's temperature from dropping and keeps them more comfortable than if active     warming were not used.   "
82887|NCT02201082|"     The purpose of this study is to determine the optimal time for the nebulization depending on     the respiratory physiotherapy session in cystic fibrosis patients.   "
82888|NCT02201069|"     The My Health Coach Study seeks to determine if health coaching by a medical assistant can     help patients have better sleep, a better diet, be more physically active or lose weight,     according to the recommendation of their health care provider.   "
82889|NCT02201056|"     The purpose of this study is to characterize the safety and tolerability profile of TAK-935     in healthy participants when administered as a single dose of oral solution at escalating     dose levels.   "
82892|NCT02201017|"     A total of 621 consecutive male and female subjects, without established CAD, referred to     exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina     with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes     mellitus who are referred EST for risk assessment prior to initiation of an exercise program.      To validate the diagnostic performance of the HeartTrends device for the detection and ruling     out of myocardial ischemia in a population of subjects who are currently referred for     cardiovascular evaluation using EST.      Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis     by the HeartTrends device for the detection of myocardial ischemia, as determined by stress     echocardiography.   "
82893|NCT02201004|"     Primary Objectives:      To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an     add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over     a period of 16 weeks in patients with type 2 diabetes mellitus.      To assess the safety of tofogliflozin in combination with insulin treatment throughout 52     weeks.      Secondary Objectives:      To assess the effects of tofogliflozin in comparison to placebo on:        -  Body weight        -  Fasting plasma glucose (FPG)        -  Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of          tofogliflozin.   "
82894|NCT02200991|"     Primary Objective:      To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a     standardized breakfast from baseline to Day 29.      Secondary Objectives:      To demonstrate:        -  Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion,          C-peptide and glucagon levels after a standardized breakfast        -  Delaying gastric emptying (13C-acetic acid breath test)        -  Safety and tolerability   "
82895|NCT02200978|"     Outcome of acute promyelocytic leukemia (APL) has greatly improved since the introduction of     all-trans-retinoic acid (ATRA). Treatment with ATRA and anthracycline-based chemotherapy     (ATRA + chemotherapy) decreases relapses of the disease as well as early hemorrhagic deaths.     Nowadays patients with APL have an event-free survival (EFS) of up to 80%. However, there     remains a subset of the patients in whom the disease relapses. Recently, a randomized     prospective study showed that the addition of ATO to ATRA + chemotherapy treatment protocol     had a significantly higher EFS in patients with APL than those treated with ATRA +     chemotherapy protocol. The patients treated with ATO + ATRA + chemotherapy had a five     years EFS of 89.2%. Moreover, a recent study showed that Indigo naturalis formula (RIF), a     traditional Chinese medicine with tetraarsenic tetrasulfide (As4S4), indirubin, and     tanshinone IIA as major active ingredients, yielded synergy in the treatment of a murine APL     model in vivo and in the induction of APL cell differentiation in vitro . It is about 20     years since RIF was used to treat ALP in China. Clinical studies showed that this agent was     effective against APL. Compared to ATO, RIF is relatively inexpensive and can be taken     orally, resulting in reducing the number of hospital days and the treatment cost. However,     there is no report comparing treatment outcomes of ATO + ATRA + chemotherapy and RIF +     ATRA + chemotherapy protocols in children with APL so far. For this purpose, therefore,     investigators are going to conduct a multicenter and randomized prospective study in children     with APL.   "
82905|NCT02200848|"     This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this     study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at     different dose levels, in combination with the drug rituximab. We want to find out what     effects, good and/or bad, they have on patients with CLL/SLL.      The hypothesis of the study is that it will be safe to give the three drugs in combination     and the information learned from this trial will be used to study the 3 drug combination is a     larger future trial.   "
82906|NCT02200835|"     Few data exist on gender-related differences in clinical features, management, and outcomes     of acute aortic dissection (AAD) in China. Accordingly, we enrolled 2015 patients with AAD     from 15 hospitals in China to access differences in clinical features, management and     outcomes between men and women. in this study, our results provided new insights into     gender-related differences in clinical features, management and outcomes in the Chinese     patients with AAD. Important implications may be helpful to improve diagnostic and     therapeutic outcomes.   "
82896|NCT02200965|"     Health professionals usually lead in the management of long term conditions such as Diabetes.     In a conventional professionally driven compliance model of care, patients may be placed in a     secondary role. National audits show components of systematic diabetes care consistently fail     despite several years of heavy expenditure in the service focused Diabetes Quality and     Outcome Framework. To what extent is this due to the nature of that process which may not     engage patients nor be focused on informed patient centred concerns? The aim of this research     is to determine the effectiveness of a healthcare delivery approach in which patients,     empowered with structured guidance and specific information about their diabetes, take     decisions to get involved in their diabetes care as determined in hard measures of engagement     and outcomes. The methodology will be by a whole population cluster randomised controlled     study of an intervention the delivery of an individualised diabetes specific structured     report, and we will look at its impact on measured key diabetes access and process outcomes.     The contention is that the patients, guided in their understanding of empowerment and     enablement, equipped with highly person specific risk stratified outcome based information,     and informed regarding which actions they may accordingly take, will be enabled to make a     significant and impactful contribution in improvement in their own care . This large scale     project can deliver on that research question in a tested , efficient and cost effective     manner.   "
82897|NCT02200952|"     The purpose of this study is to prove that luteal phase supplementation with recombinant LH     can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk     of OHSS   "
82898|NCT02200939|"     The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after     implantation of the Rotation Medical Bioinductive Implant used as either a standalone device     or adjunct to surgical repair in the treatment of supraspinatus tendon tears.   "
82918|NCT02200679|"     The aims of the national population-based study on Autism Spectrum Disorder (ASD) include:     (1) to understand the overall prevalence of ASD in children aged 6-12 years in 8 cities     (n=120,000), (2) to explore environmental and genetic risk factors associated with ASD   "
84548|NCT02179359|"     This is a study to collect the outcomes of stem cell transplantation for patients with     hematologic diseases other than cancer.   "
82899|NCT02200926|"     The previous studies used the slow loaded breathing device for breathing training (Jones et     al., 2010). It has been shown that slow loaded breathing training can reduce resting blood     pressure and heart rate in essential hypertensive patients. However, this has not been     studied in elderly with essential isolated systolic hypertensive patients. Not only highest     prevalence of hypertension in Thailand was found in elderly but also physiological changes in     the elderly are cause of interest in this special population. It has many advantages to use a     slow loaded breathing training in elderly people. Firstly, it is low technology and easily     implemented at home. Secondly, it can be practiced almost anytime and anywhere. Thirdly, the     orthopedic complications of slow loaded breathing training are minimal. Finally, slow loaded     breathing training may be enhancing cardiopulmonary function and other fitness traits, but it     out of scope of this study. Moreover, slow loaded breathing exercise by itself should not     result in any metabolic adaptation of skeletal muscles, such as the forearm, which had not     been trained. If slow loaded breathing training modified some central component of the     pressor reflex pathway in a way that single muscle training might work, as suggested above,     then loaded breathing training would have a modulating effect on the pressor responses of     muscles that had not been trained.      We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax     on blood pressure at rest and exercise in elderly with essential isolated systolic     hypertension and also investigate the autonomic function and others that may be involved with     the changed blood pressure in elderly with essential isolated systolic hypertension. We     hypothesized that slow loaded and unloaded breathing training could reduce resting and     exercising blood pressure in elderly with essential isolated systolic hypertension.   "
82900|NCT02200913|"     Recent studies indicate that patients with chronic low back pain (LBP) present problems in     balance. Alterations in proprioception are the possible causes of alteration of postural     balance in LBP.      Previous studies reported an improvement of CSE on joint mobility, pain, functional     disability, and trunk muscle activation pattern in patients with clinical lumbar instability     (CLI); however, it was an immediate effect. However, previous studies did not report indirect     effect may occur in CLI as postural balance and other kinds of exercise as strengthening in     CLI. The general trunk strengthening exercise is common used in physical therapy clinic on     LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge,     the usefulness of CSE has not yet been investigated in CLI patients with outcome measure of     balance.      The present study will conduct to fill the gaps of previous studies which will provide     immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity     and ratio activation of trunk muscles and included blinding process of the assessor.   "
82901|NCT02200900|"     The most commonly used noninvasive respiratory support in preterm babies is Continuous     Positive Airway Pressure (CPAP), which provides extra breathing support to babies who are     breathing by themselves). Increasingly High flow Nasal Cannula (HFNC, newer form of extra     breathing support) therapy has found its way in clinical practice despite lack of good     physiological data. There are also concerns about its potential to generate higher pressures     in airways which can cause over distension of lungs.      We would like to find out the effects of HFNC on        -  1. Airway pressures in various flow rates and in comparison to CPAP.        -  2. Breathing markers including respiratory rate (speed of breathing), oxygen and carbon          dioxide levels, tidal volumes (how much air breathed in with each breath) and airway          wash out (wash out of waste gas from the airway).      We plan to study 15 babies each in three different weight categories supported with either     CPAP or HFNC. The airway pressures, oxygen and carbon dioxide concentration in airway are     measured by a small plastic catheter (similar to feeding tube but much shorter in length),     carbon dioxide levels by skin sensors, how fast and how much babies breathe by a special vest     applied like a layer of clothing. These will be recorded both on HFNC and CPAP. There are no     blood tests or invasive procedures involved. The baby will be monitored throughout the study     period of approximately two hours by experienced registrar who is trained to use the study     device.      This study will improve our understanding of physiological effects of HFNC and lead to better     care of preterm babies.   "
82902|NCT02200887|"     Parkinson's disease is characterized in the advanced phases by an altered response to     dompaminergic therapy for the occurrence of abnormal movements called dyskinesias, that     worsens the quality of life of the patient and exposes him to comorbidities. Several data     show a reduction in the amount of slow wave sleep that corrrelates inversely with disease     duration. Since this stage of sleep is linked to mechanisms of deletion of superfluou     information we hypothesize that the onset of dyskinesias is related to such alteration of     sleep.      -With this study we want to investigate, by means of high-density electroencephalography     (hd-EEG), the sleep and in particular the slow wave in order to clarify the relations with     the development of dyskinesias.   "
82903|NCT02200874|"     The purpose of this study is to investigate the effectiveness and efficiency of a structural     clinical nutrition support by an interdisciplinary Nutrition Support Team. To do this we     examine nutritional management and its economic impact as well as the nutritional status of     patients of University Hospital Tübingen before and after the implementation of a Nutritional     Support Team.   "
82909|NCT02200796|"     Objectives: To determine the effect of protein content of familiar breakfast meals on     subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in     normal weight (NW) and overweight (OW)/obese (OB) children.      Specific Objectives:      1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying     in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food     intake at a test meal 4 h later in NW and. OW/OB children.      1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in     protein (optimal protein from Objective 1a) or low in protein on TEF and substrate     utilization over 5 h in NW and OW/OB children.   "
82910|NCT02200783|"     Excessive radiation received by the operator has been described as a possible drawback of the     radial catheterization technique when compared with the femoral access.      The study hypothesis is that the use of radial access device dedicated radioprotective     TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral     technique and superior to standard radial technique as radioprotection strategy to the     operator in patients with acute coronary syndromes acute and submitted to cardiac     catheterization.   "
82911|NCT02200770|"     To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD     attack in subjects with NMO/NMOSD.   "
82912|NCT02200757|"     The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to     topotecan in subjects with metastatic small cell lung cancer.   "
82913|NCT02200744|"     The purpose of this study is to determine the incidence of recall in patients managed in     emergency department with a procedural sedation protocol using propofol in a population of     250 .   "
82914|NCT02200731|"     To investigate whether a home-based psychosocial family intervention that takes place shortly     after ending the primary medical treatment can help families adjust to their cancer-related     psychological issues.   "
82919|NCT02200666|"     The purpose of the investigation is to confirm the following under the post-marketing actual     use of Forxiga Tablets (hereinafter referred to as Forxiga)        -  Development of ADRs specified as Key Investigation Items and the risk factors        -  Contributing factors possibly having an impact on the safety and efficacy        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug          use   "
82920|NCT02200653|"     The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and     COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during     the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives     include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during     the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline     in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline     in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4)     responder rates based on both ABPM and trough cuff blood pressure   "
82921|NCT02200640|"     The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan 40-80 mg)     and COZAAR® (losartan 50-100 mg) in lowering ambulatory diastolic blood pressure (DBP) during     the last 6 hours of the 24-hour dosing interval as measured by ABPM after 8-weeks treatment.     Secondary objectives include evaluations of: 1) change from baseline in mean systolic blood     pressure (SBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2)     changes from baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3)     changes from baseline in mean seated trough SBP and DBP as measured by manual cuff     sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff blood pressure   "
82922|NCT02200627|"     The purpose of the investigation is to confirm the following under the post-marketing actual     use of Forxiga Tablets (hereinafter referred to as Forxiga) in elderly patients.        -  Development of ADRs specified as Key Investigation Items and the risk factors        -  Contributing factors possibly having an impact on the safety and efficacy        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug          use   "
82924|NCT02200601|"     The study sponsor has developed a patented medical device called Seipher Wellness. This is a     non-invasive medical device that assesses heart health based on established cardiac     parameters; timing events of the cardiac cycle. These are specific parameters captured and     analyzed by the device. A ratio of two specific timing parameters provides an assessment of     the subject's overall heart health. The aim of this study is to validate the device algorithm     across a range of subjects.   "
82936|NCT02200432|"     The purpose of this study is to maximize patient perspective and effectively support     lifestyle choices, investigators will develop the Patient Experience Recommender System for     Persuasive Communication Tailoring. PERSPeCT is a computer system that will assess adult     smokers' perspective, to understand the patient's preferences for smoking cessation health     messages, and provide personalized, persuasive health communication that is useful to the     individual patient in making positive health behavior changes such as smoking cessation.   "
83118|NCT02198040|"     The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one     with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation     (PNF), and the other with education sessions and home exercises, for the improvement of the     ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of     the elbow.   "
82925|NCT02200588|"     Schizophrenia is a chronic brain disease that is still understood as a condition that limits     the development of a normal life for the patient who suffers it and their families. The idea     that only one third of patients have a good outcome is still in force, despite the lack of     clinical and epidemiological longitudinal studies that have addressed this issue rigorously.     Most studies that have established the poor prognosis of the disease have followed a     cross-sectional design and are based on samples of patients undergoing treatment in     healthcare devices and therefore represents an important bias. Based on clinical, cognitive,     functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can     establish that the particular idea of poor prognosis should be reconsidered. The development     of longitudinal studies of first-episode patients in representative samples of a population     and long-term it is of high value to shed light on the clinical course of the disease. The     belief that there are factors determining the disease progression beyond the initial three     years brings us to publish this study.      Given this background, our project's main objective is to know the evolution at 10 years of     patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is     that a higher percentage of expected patients have a favorable outcome of the disease.     Factors such as enhancing treatment completion, abstinence from drug use, return to work, the     reduction of expressed emotion in families during the early years of the disease (at least 3     years of intensive intervention PAFIP) will have a positive impact on the evolution of     patients on long-term (10 years). Our hypothesis defends the existence of certain factors as     independent risk factors for poor clinical and functional outcome of patients who should be     known for establishing intervention strategies that attempt to mitigate their impact on the     quality of life of patients and their families.   "
82926|NCT02200575|"     Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal     conditions of use after market launch and to supplement the present data on the safety of     telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to     control blood pressure for 24 hours, especially during the last few hours of the dosage     interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and     to confirm the efficacy and possible risks associated with treatment.   "
82927|NCT02200562|"     Phase I/II study of ipilimumab concurrent ipilimumab and dabrafenib as first line treatment     in Stage III or IV melanoma.      Assessing safety of Ipilimumab and dabrafenib in combination. Also, assessing disease control     rates.   "
82928|NCT02200549|"     Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world,     represents an important public health challenge. It is also a major cause of chronic     morbidity, mortality and disability throughout the world, leading to a heavy social and     economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently,     pulmonary rehabilitation is recognized as a core component of the management of individuals     with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea,     increase exercise capacity, and improve quality of life.      Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of     the best available means of improving muscle function in COPD.The most commonly form is cycle     training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an     additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient     with COPD.      There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle     training and cycle training. This study will evaluate the effects of combined inspiratory     muscle training and cycle training in patients with COPD.   "
82929|NCT02200536|"     Governmental initiatives (such as Sure Start in the UK) have integrated an oral health     promotion intervention within their maternal and child health program and delivered dental     education and enabling resources (a gift bag including a baby toothbrush, fluoride toothpaste     and a trainer cup) to infant's mothers. Whilst this approach has minimal financial     implications of human resources, no evidence exists regarding its effectiveness in     establishing desirable infant's oral health behaviours. In Syria, there is a great need for     developing an infant's oral health promotion program to promote oral hygiene practice,     provide access to fluoride and terminate bottle-feeding practice. Thus, the current study     aimed to test the effectiveness of an integrated infant's oral health promotion intervention     within the Syrian national immunization program, which delivered printed dental education     materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in     establishing one-year old infant's oral hygiene and bottle-feeing termination practices.   "
82930|NCT02200523|"     The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining     multiple steps that burden conventional EEG procedures into one. The investigators believe     that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20     minutes) with additional time savings on cleanup. Reducing the hookup time required for the     EEG recording will make EEG more feasible in time critical situations and will improve     patient care and service. The clinical testing in Phase II will investigate patient     acceptance, clinician acceptance, time savings, and signal quality for 3 different     environments: the large hospital institution, a small rural hospital setting and in an     emergency department.   "
82931|NCT02200510|"     The purpose of the study is to develop patient-provider clinical support tools to improve     clinical practice, patient self-management, and disease outcomes in sickle cell disease     during transition to adult care. The investigators hypothesize that these clinical support     tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible,     user friendly, and beneficial. The investigators hypothesize that participants will     demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain     these gains during the follow-up period (up to 1 year post-intervention).   "
82932|NCT02200484|"     Specific Aims:        1. The primary aims of this study are to conduct formative interviews with teen mothers to          inform a targeted adaptation of empirically based weight management and parent training          programs for teen mothers for their preschoolers.        2. To conduct a small pilot and post-pilot focus group of the feasibility and acceptability          of recruitment and retention methods & the intervention.      Study Hypotheses:      Given the small sample size and fact that this is a pilot study, focus will be on estimating     effect sizes rather than statistical hypothesis testing. However, the investigators     exploratory hypotheses are as follows:        1. (a) The adapted intervention will be more feasible compared to the wellness control          condition, with a participant retention rate of ≥80% and an average adherence          (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥          75%; (b) The adapted intervention will be more acceptable compared to the wellness          control condition, based on the Consumer Satisfaction Scale and Therapy Assessment          Inventory with ≥90% of the participants responding to the item, In general how          satisfied were you with the intervention? by choosing unsatisfied to very          satisfied.        2. (a) The adapted intervention will result in greater improvements in child behavior and          parent-child connectedness compared to the control condition; (b) the adapted          intervention versus wellness control condition will result in greater increases in child          and teen mother individual as well as joint physical activity and physically active play          and greater reductions in individual and joint teen mother and child sedentary behavior          (television viewing) from baseline to post-intervention; (c) the greater teen mother and          child fruit and vegetable consumption; and reduced child juice and sugar-sweetened          beverage consumption from baseline to post-intervention; (d) the adapted intervention          versus wellness control condition will result in smaller increases in child BMI          percentile and teen mother BMI from baseline to post-intervention; (e) participants who          attend higher numbers of intervention sessions will show greater improvements in target          outcomes (child behavior, parent-child connectedness, and teen mother and child physical          activity, sedentary behavior and BMI); with participants receiving the adapted          intervention versus wellness control showing the greatest dose-based improvements.   "
82933|NCT02200471|"     This study aims to understand the impact of VeinViewer technology during routine cosmetic and     dermatologic procedures.   "
82937|NCT02200419|"     This multi-centre study will provide sound, generalizable data on the effectiveness of a     POC-based algorithm to determine to what extent this guideline can reduce blood product     transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at     10 participating hospitals. The proposed trial addresses several important research and     clinical issues and has the potential to markedly improve the transfusion management and     surgical care in general of cardiac surgery patients.      The intervention will be a novel POC-based algorithm that has been shown in a pilot study by     us to be associated with a substantial reduction in blood product transfusions. The algorithm     will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss.     The primary outcome will be avoidance of red blood cell transfusion during hospitalization.     The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will     include avoidance of red blood cell use and other blood products (plasma, platelets, and     cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related     to transfusion (acute kidney injury, infections, and death). Data will also be collected for     future health-economics analyses.      Largely due to the limitations of existing evidence, however, such algorithms are rarely used     in clinical practice. The proposed trial will provide sound, generalizable data on the     effectiveness of a POC-based algorithm to guide their future use. An integrated blood     management algorithm that employs POC coagulation tests will reduce blood product     transfusions in cardiac surgery, thereby improving clinical outcomes.      Does an integrated blood transfusion algorithm that employs POC coagulation tests applied     across a network of hospitals reduce blood transfusions and associated adverse outcomes in     cardiac surgery?   "
82938|NCT02200406|"     Background: Although substitution therapy has been shown to be highly effective to retain     opioid-dependent patients in treatment and reduce drug use, this population is afflicted by     numerous conditions including depression. Unfortunately, studies published thus far have     reported inconsistent or no difference in response between placebo therapy and     antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the     feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and     explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV     50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the     Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down     the foundation on which a larger multisite clinical trial could be conducted to examine DESV     as new treatment for opioid-dependent population with comorbid depression.   "
82939|NCT02200393|"     Compromised respiratory function as a result of tetraplegia leads to many tetraplegics     requiring mechanical ventilation during the acute phase of injury. Mechanical ventilation is     associated with additional costs to the local health care provider and reduced quality of     life of the patient. Electrical stimulation of the abdominal muscles has previously been used     to improve the respiratory function of tetraplegic patients in the chronic stage of injury.     In this study the investigators aim to evaluate whether electrical stimulation of the     abdominal muscles can assist the process of weaning from mechanical ventilation in acute     ventilator dependent spinal cord injured patients.   "
82940|NCT02200380|"     This is an open-label, multicenter, prospective pilot study of CDX-301 with or without     plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from     another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol     specified hematologic malignancies (recipients) will be enrolled.   "
84549|NCT02179346|"     Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with     full thickness cartilage defects in the hip.   "
82941|NCT02200367|"     In the treatment of depression, primary care team play an important role, but they are most     effective when inserted into a collaborative model of disease management.      Hypotheses:Depressed patients treated in rural primary care clinics participating in a     e-mental heath collaborative programme to manage depression achieve at least 20% better     recovery rates in comparison with the control group three months after the baseline     assessment.      Goal: to compare the effectiveness of a e-mental health collaborative programme with usual     care in rural primary-care clinics.      Methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals     in Chile. The active group will participate in a collaborative programme between primary care     teams and specialized teams, with support from an electronic platform and a call center.The     control group will receive usual care, according to the Ministry of Health's Guidelines to     Depression.To evaluate inclusion criteria -depressive patients aged between 18 and 70 years-     and exclusion criteria -current in treatment for depression- an interview will be used that     will include the Mini-International Neuropsychiatric Interview (MINI) to evaluate depression     .The principal outcome will be depressive symptoms measured with the Beck Depression     Inventory (BDI-I), and secondary outcome quality of life measured with the Health Survey     (SF-36) at three and six months after baseline assessment.To detect a difference of 20%, in a     one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons     (76 to intervention and 76 to control group).A design effect of 1.35 based on an Intraclass     Coefficient Correlation (ICC) of 0,03839 and 13 clinics were considered. After applying the     design effect the sample needed increased to 206 depressed persons. Considering a retention     rate of approximately 85% 237 depressed cases will be needed.      A program of this kind may be useful to assist primary care teams in remote areas of the     country, in order to improve treatment outcomes for depression that is currently addressed at     the primary care level.   "
82942|NCT02200354|"     For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and     cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the     PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not     progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted     from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab     continuous maintenance might be better treatment option, considering the results from     AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients.     Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with     bevacizumab,we conducted this study.   "
82943|NCT02200341|"     The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive     Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in     individuals suffering from major depressive disorder (MDD).   "
82944|NCT02200328|"     The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing     the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk     for this infection.   "
82945|NCT02200315|"     The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial     prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.   "
82946|NCT02200302|"     Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the     vertebrae and discs gradually develop a curvature that is first detected in patients between     11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from     radiographs by the Cobb angle .      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each     vertebra and disc between the superior and inferior end vertebrae . Although a small curve is     well tolerated and does not require treatment, a large curve can progress to the point that     it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac     and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the     initiation of the curve and its subsequent progression. The factors responsible for the     initiation of the curve are unknown, but the subsequent progression of the curve is clearly     associated with the adolescent growth spurt . The primary risk factors for progression     include age at onset and the magnitude of the curve; young patients with large curves are at     the highest risk .      Although numerous treatment methods have been recommended for patients with AIS, the only     accepted treatment includes bracing for skeletally immature patients with curves between 25     and 40 degrees and operative correction with spinal fusion for patients with curves greater     than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing     has caused compliance problems with wearing the brace and many patients only wear the brace     at home . While operative intervention completely corrects the scoliosis or rib hump, it     eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion     potentially leading to disc degeneration and back pain.      Despite satisfactory short-term results of operative instrumentation and fusion, a less     invasive technique preserving more motion with a smaller scar represents a major improvement.     Realizing this goal is contingent on treating curves early, before they progress to an     irreversible deformity, and when there is still enough residual growth and remodeling     potential.      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system     is designed to correct the deformity step by step along a period of time, giving the skeletal     and soft tissues time to accommodate any incremental correction.      The MID-C System inherent benefits are:        -  Only two screws are used        -  Incision size is much smaller        -  Simpler operation with shorter operative time        -  Less complications (attributed to the three points above).        -  Minimal spinal mobility loss.      All the device components are made of materials well accepted in the orthopedic field and are     fully biocompatible (see Investigator Brochure).      The unique concept of the system and the materials used may provide favorable results as     follows: Smaller scare, quicker healing period and better spine mobility over the years.      This study is designed to demonstrate that the MID-C System is safe and effective.   "
82960|NCT02200120|"     The purpose of this study is to examine the placement, timing, associated complications,     efficacy of temporary and tunneled catheters for renal replacement therapy in patient with     acute kidney injury.   "
82961|NCT02200107|"     The purpose of this study is to determine the ability to assimilate and implement an     integrated treatment program osteoarthritis of the knee, including the diagnosis and     follow-up by a family physician in primary care clinics, combined with patient self-care     training and physiotherapy program   "
82962|NCT02200094|"     This study is designed to supplement, under conditions of usual clinical practice, the data     on the efficacy and safety of Micardis® collected during the clinical studies.   "
82963|NCT02200081|"     Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC) as     maintenance treatment in patients with extensive disease small cell lung cancer (SCLC) who     achieved at least a partial response (PR) following platinum-based first-line therapy.   "
82947|NCT02200289|"     Household air pollution from cook stoves using solid fuels dominates total population air     pollution exposures. Females and young children are disproportionately affected as they     either perform or are present for the majority of cooking activities. Worldwide, household     air pollution is responsible for 1.6 million premature deaths annually, largely secondary to     respiratory tract infections, and 2.7% of worldwide disability-adjusted life years. Children     that survive childhood are not free from disease; the WHO estimates that 35% of COPD cases     worldwide are secondary to household air pollution. Reducing female and infant morbidity and     mortality related to household air pollution secondary to biomass smoke exposure is a     top-priority public health goal.      We hypothesize that in utero biomass smoke exposure results in a fetal oxidant imbalance,     which negatively impacts lung development. We will leverage the success of the Ghana     Randomized Air Pollution and Health Study, a randomized cook stove intervention trial of     1,415 mother-infant pairs, to examine the impact of maternal household air pollution exposure     on cord blood oxidant imbalance and infant pulmonary function. We aim to enroll at least 150     infants, analyze cord blood samples for markers of oxidant imbalance and perform infant     pulmonary function testing. Cord blood will also be prepared for future immune, hormonal and     epigenetic testing. This study will allow us to consider interventions, such as maternal     antioxidant dietary supplementation during pregnancy, to compliment existing cook stove     interventions and reduce household air pollution-related morbidity and mortality.   "
82948|NCT02200276|"     The immune system is the part of the body that protects against infection. The immune system     often doesn't work as effectively as people get older. This research is being done to find     out how the immune systems in older people who are over age 75 respond to influenza vaccine     (flu shot). We also want to find out if chronic cytomegalovirus (CMV) infection, a common     virus infection in older persons affects the immune response in people older than 75 years of     age who receive a flu shot. The Flu Shot is a vaccine approved for the prevention of     influenza (Flu) infections and is recommended every year for all persons 50 years and     older. People who are older than 75 years of age are considered healthy or frail may join. A     total of 525 persons will be participating in this study.      In order to determine if you are qualified for the study, we would ask you to answer a few     questions over the phone that will take approximately 5 minutes. If you qualify and agree to     proceed, you will be asked to come to Johns Hopkins Bayview Medical Center or, if you are     unable to come to Bayview, one of our staff can visit you at your home. During that visit we     obtain consent, review your medical history, and measure your vital signs, walking speed and     grip strength. We will also administer a few brief questionnaires and collect urine and blood     samples. We will then give you the Flu shot for free. Three to four weeks after you receive     the Flu shot, you will have another visit at Johns Hopkins Bayview or your home where we will     repeat some of the questionnaires, vital signs, and collect a second blood sample. Throughout     the study, we will call you once a week to ask about your general health and any Flu-like     symptoms. These calls will be made throughout the Flu season which typically lasts through     the end of May. If you begin to have any influenza like symptoms at any time during the     study, we ask that you call our office to report these symptoms so that we may perform a     nasal swab to confirm influenza, and a third blood draw to look at the immune response and     protection of influenza vaccine.   "
84561|NCT02179190|"     Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an     adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms     in the middle cerebral and basilar arteries.   "
82949|NCT02200263|"     The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects     of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or     oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo     (no treatment) gel pill over the period of 12 months, with study visits approximately every 3     months for the first year and a final visit 18 months after enrollment.   "
82950|NCT02200250|"     Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for     Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).   "
82951|NCT02200237|"     This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in     health children and infants aged from 2 months to <12yrs.   "
82952|NCT02200224|"     The purpose of this study is to:        1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae          (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the          Emergency Department (ED) for a Sexually Transmitted Infection (STI).        2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic          under and over treatment for TV in women evaluated in the ED for an STI        3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria          Gonorrhoeae (NG) and TV testing in the Emergency Department setting.      To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually     Transmitted Infection diagnosis.   "
82953|NCT02200211|"     The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play     7 days per week with 2 hours/day patching 7 days per week in children 5 to <17   "
82954|NCT02200198|"     Malnutrition affects 50% of hospitalized patients around the world and causes changes in     respiratory muscles predisposing the development of pulmonary complications probable, because     of the ineffectiveness of cough. How the training of respiratory muscles can improve the     effectiveness of cough, malnourished patients could benefit from this train however, the     training of the muscles in malnourished patients has not been tested for safety or     efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory     muscle training to improve the potency of cough in malnourished patients.   "
82955|NCT02200185|"     The investigators test a different technique using morphine to improve pain relief in patient     visiting the emergency department with acute trauma pain, for this we are comparing three     different methods of morphine administration:        -  intravenous titrated morphine        -  low dose nebulized morphine and        -  high dose nebulized morphine   "
82956|NCT02200172|"     The purpose of this feasibility study is to inform a larger randomized, placebo-controlled,     double blind, parallel-group, single-centre trial of an oral, daily administered single dose     of melatonin to prevent delirium in patients with advanced cancer.   "
82957|NCT02200159|"     Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU   "
82958|NCT02200146|"     The aim of the study is determining the non-inferiority in the overall success rate and the     safety for a combination therapy with hydroxychloroquine plus low dose glucocorticoids     compared to that for high dose glucocorticoids at 3 and 9 months in patients with pulmonary     sarcoidosis.   "
82959|NCT02200133|"     This randomized study will compare a personalized Survivorship Care Plan (SCP) template with     usual care (no SCP). The investigators hypothesize that the personalized SCP that     incorporates patient specific treatment exposures and provides a framework for long term     followup based on those exposures and subsequent risks for late complications will enhance     patient survivorship confidence in knowledge, increase adherence to recommended healthcare,     improve health behaviors and reduce HCT-related emotional distress.   "
82964|NCT02200068|"     Recommendations of Rheumatoid Arthritis management agree on the necessity of patient     self-involvement in the care. In parallel, the observation of the adoption rate of websites     directed toward patients may indicate that this involvement is shared by a large number ot     the population.      However, most of these sites are only informative and few of them offer patients to be     engaged to generate their own data that can impact on the patient-physician relationship by     easing the dialog and then leading to better mutual understanding.      As new web or mobile services allowing patients to self-report their outcomes are flourishing     only a very few of them have already addressed the their impact of the patient-physician     relationship.      The main objective of this study is to quantify the effect of a website (Sanoia) on the     quality of patient-doctor interactions, as perceived by the patient using the french     translations of the Peppi Questionnaire during the 12 months observation period.      In France, the patient protection committee (CPP) has ranked this study in Soins Courants     (Usual Care).   "
82965|NCT02200055|"     Being able to accurately monitor patient bodily fluid levels during and after surgery is very     important, as there are a number of complications that can arise if a patient's fluid levels     become unbalanced, such as swelling within or pressure on various bodily organ systems. There     are several different ways that physicians can monitor a patient's fluid balance during and     after surgery, such as measuring the amount of urine output or the use of central venous     catheters which measure the pressure in the veins entering the heart. Most of these     techniques are invasive since they require tubes to be inserted into the body. A potential     alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).      Bioimpedance assessments work by using small electrical currents that can accurately predict     both the water surrounding the outside of cells in the body, as well as the total amount of     water in the entire body. Electrical bioimpedance assessments have been used to estimate     patient swelling following surgery (edema), to measure the volume of blood the heart is     pumping out, as well as to calculate body fat percentages.      The goal of this study is to relate this technology to fluid shifts within the body that     occur as a result of surgery, in particular, major intra-abdominal surgeries. By using     bioimpedance during and after surgery, the investigators will compare the data collected with     that calculated by using traditional measures of body fluid status, such as urine output and     intraoperative blood loss. During the study, the bioimpedance monitors will not replace the     standard bodily fluid monitors and will not interfere with their readings. Additionally, the     electrical current produced by the bioimpedance monitors is too small for patients to feel     and will not interfere with medical devices such as pacemakers.   "
82966|NCT02200042|"     This randomized phase III trial studies how well gemcitabine hydrochloride and cisplatin with     or without radiation therapy work in treating patients with localized liver cancer that     cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation     therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving     gemcitabine hydrochloride and cisplatin is more effective with or without radiation therapy     in treating patients with localized liver cancer that cannot be removed by surgery.   "
82967|NCT02200029|"     A research study of an approved drug called Heptral®, ademetionine, to treat adults with     intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum)     in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with     liver disease has shown that ademetionine is effective.   "
82968|NCT02200016|"     Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A     randomized controlled double blinded MRI study comparing long versus short axis catheter     placement. Which procedure for insertion of nerve catheters for postoperative pain after     major foot and ankle surgery is the best   "
82969|NCT02200003|"     Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective,     and easy to administer, targets a key mechanism in pathological anxiety - the threat bias, or     exaggerated attention feared or threatening stimuli. It remains unclear how and for whom ABMT     is effective, limiting clinical translation. The proposed research involves an RCT using a     highly sensitive measure of neurocognitive functioning, scalp-recorded event-related     potentials (ERPs), to delineate key mechanisms of an emerging treatment for anxiety.     Researchers will recruit 90 anxious participants to engage in the study and pursue the     following three specific aims: Aim 1 will examine relations between neural and behavioral     responses to threat prior to ABMT. Aim 2 will examine the effects of ABMT on ERPs to threat,     threat bias, and anxiety. Aim 3 will examine relations between ERP responses to threat and     reductions in threat bias and anxiety. Researchers will test whether post-training neural     changes, specified in Aim 2, are associated with reductions in behavioral threat bias and     anxiety severity. Researchers will also explore whether ERP measures of greater attention     capture and/or reduced control of attention to threat at baseline predict treatment response,     helping identify which patients will benefit most from ABMT. Through the innovative     combination of a highly sensitive neurocognitive measure and an RCT design, this study aims     to delineate core neurocognitive responses to threat as mechanisms in the remediation of     anxiety. Confirmation of study hypotheses would, ultimately, accelerate the pace of     development of more biologically-informed, accessible, and targeted interventions for     anxiety.   "
82970|NCT02199990|"     Based on China's guangxi guilin for a hernia operation in 1 to 3 years old preschool children     propofol and etomidate on behavioral and cognitive function after intravenous anesthesia in     according to beta protein in serum and plasma glutamate (Glutamic acid, Glu) and     gamma-aminobutyric acid (Gamma aminobutyric acid, GABA) level of observation, the rapid     development period children's cognitive function after anesthesia short-term and long-term     change process and its possible mechanism is studied, for the current international debate on     anesthetics effects on developing kids brain nerve research hot spot in the city of     clinical basis and research argument, for pediatric anesthesia clinical safety, provide     theoretical basis for the rational use of drugs.   "
82981|NCT02199847|"     The general aim of this study is to assess the effects of Pharmaton® Caplets on mental     performance and physical fatigue in nurses and nursing auxiliaries working night shifts   "
82971|NCT02199977|"     There are compelling medical and public health reasons to reduce unnecessary consumption of     antimalarials and strong evidence to support the use of RDTs in malaria case management. The     primary study hypothesis to be tested is that clients who know they will receive a subsidy     conditional on a positive test are more likely to opt for testing before deciding which drug     to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid     diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination     therapy (ACT) or not. The primary outcome of interest is to compare the proportion of     participants who choose to receive a free malaria diagnostic test when they can receive a     subsidy for a discounted drug conditional on a positive test (Group A compared to Group B)     compared to those without the offer of a conditional subsidy. The investigators will use an     experimental design that randomly assigns clients to one of four groups. Field workers will     canvas households in the study area looking for individuals who have fever or history of     fever or illness in the last 24 hours (current illness) who have not yet taken drugs or     sought treatment outside the home. Clients who meet the inclusion criteria and give verbal     consent to participate will be randomly assigned to one of the four groups. They will be     given the location and contact information for their local community health worker who can     provide a malaria rapid diagnostic test if they choose to be tested. They will also complete     a survey tool. One week later, the field worker will return to interview the participant and     determine whether they were tested, what action they took for their illness, what medicine     they purchased and how much they paid. The investigators will summarize clients' choice by     the four randomized study groups.   "
82972|NCT02199964|"     This study will test that hypothesis that topical administration of the FDA approved     immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface     disease that results from a short term low humidity environmental stress   "
83023|NCT02199288|"     This prospective, open-label, multicenter, observational study will investigate the     effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in     patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV     (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8     months.   "
83024|NCT02199275|"     During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a     performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general     anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.   "
83038|NCT02199093|"     The purpose of this study is to analyze the effects of a mixed intervention of occupational     therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and     moderate patients post stroke in comparison to a control group with a traditional health     educative protocol.   "
82973|NCT02199951|"     WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of     uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the     African market and will be used by the public health care system. The collection of safety     data and risk evaluation through observational data are critical in order to assess     risk/benefit profile of each ACT through its life cycle and providing information on the best     use. Additionally there is need to assess the impact of the introduction of a new ACT in the     evolution of its efficacy and malaria morbidity and mortality. Dihydroartemisinin/Piperaquine     (DHA/PQP) is a new ACT approved by European Medical Agency and a number of African countries.     This is a phase IV observational evaluation of the clinical safety of the fixed-dose DHA/PQP     (Eurartesim®) in public health facilities within selected Health and Demographic Surveillance     Centres in Burkina Faso (Nouna), Mozambique (Manhica), Ghana (Dodowa, Kintampo, Navrongo),     Tanzania (Rufiji) and other African countries to be added. Eurartesim® will be used as     first-line treatment of uncomplicated malaria an objective to evaluate the safety of     Eurartesim® when used under usual conditions in 10,000 patients. Patients > 6 months and 5 kg     except pregnant women will be enrolled and Eurartesim® administered as a single daily dose     regimen over 3 days. Patients will be contacted at Day 5 (± 2 days) after treatment, to     assess recovery and any adverse events.   "
82974|NCT02199938|"     The aim of the study is to improve the understanding of molecular mechanisms in the     development and progression of musculoskeletal tumors. These tumors do have in general     unfavorable prognosis and conventional treatments (e.g. surgery, radiotherapy or     chemotherapy) could not enhance the prognosis of these patients during the last ten to     fifteen years. Therefore the investigators chose a new way, as they try to identify markers     on a genetic level, who ideally act as a basis to develop new treatment options.   "
82975|NCT02199925|"     If autism is the consequence of a chronic inflammatory process preventing the infant brain     from forming the proper neural connections, then treatment that reduces inflammation might     have a positive impact on autism. IGIV treatment has been known to suppress inflammation and     has been used in the treatment of inflammatory conditions and autoimmune diseases.   "
82976|NCT02199912|"     Cachexia associated with cancer is a grave and most of the time irreversible common     situation. It seems independent from the size of the tumor or from its metastatic character.     The consequences for the management of the patient are major and exceed widely the frame of     the nutrition.      Undernutrition of patients with cancer is described by a decrease of the energy contributions     and a loss of muscular and fat mass, leading to a progressive functional deficiency which can     go to the cachectic state.      Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia     but it remain too indistinct to allow an early and efficient screening and set up effective     measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast     iron of the energy reserves.      It is necessary to have clinical and biological markers with diagnostic aim and forecasts     during the situations precedents the appearance of cachexia.      The present study will allow calibrating a longitudinal study, which could confirm the value     of measures made for the diagnosis of pre-cachexia.   "
82977|NCT02199899|"     The objective of the present study is to obtain information about the safety and tolerability     of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a     citric acid challenge test and to obtain preliminary pharmacokinetic data   "
82978|NCT02199886|"     Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics     associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in     tumour to that of normal tissue in patients with non-small cell lung cancer and to measure     human anti-human antibody (HAHA) concentrations.   "
82979|NCT02199873|"     The objective of the present study is to obtain information about the safety and tolerability     of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a     methacholine challenge test and to obtain preliminary pharmacokinetic data   "
82980|NCT02199860|"     The purpose of the present study was to obtain information about the safety, tolerability and     pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of     spray-dried powder in healthy male and female volunteers. According to the original protocol,     the primary objective was to investigate the safety and tolerability of single doses of a new     spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of     Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD     II with and without concomitant administration of lactose   "
82982|NCT02199834|"     In this project, the investigators hypothesize that in an integrated, multifaceted,     team-based program incorporating comprehensive assessment with risk stratification, diabetic     patients with high risk of negative emotions and hospitalization will benefit from additional     peer support which will improve their psychological health, cardio-metabolic control,     self-management, quality of life and reduce hospitalization. The investigators further     hypothesize that peer support will interact with regular personalized feedback reporting to     improve clinical outcomes.   "
82983|NCT02199821|"     Background and Aims: Nutritional support is considered an integral part of the supportive     care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with     omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare     plasma cytokines levels in children after bone marrow transplantation using a lipid formula     enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.      Methods: A randomized double blinded controlled study including 14 children with BMT and     requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or     soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to     analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha     (TNF-α).   "
83036|NCT02199119|"     The purpose of this study was to describe the effect of 30 min TV viewing with or without     simultaneous moderate exercise using a treadmill on subsequent subjective appetite,     satiation, and food intake in normal weight 9 to 14 year old children. It is hypothesized     that TV viewing during exercise immediately before mealtime affects food intake regulation     through its effect on the control of appetite and satiation.   "
83037|NCT02199106|"     Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to     modulate auditory cortex activity and plasticity contributing to the perception and distress     of chronic tinnitus.   "
82984|NCT02199808|"     Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related     changes in executive functions in children and older adults.      Participants: Eighty-four typically-developing 7-to 12-year-old children.      Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three     sessions will consist of the screening. These sessions will be telephone calls to collect     24-hour diet information that will be used to determine whether they are eligible for the     fourth session. Approximately 120 participants will be screened to find 84 participants who     are eligible for the fourth session, in which participants will complete a series of tests on     the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that     provides computerized versions of standardized cognitive tests. They will also complete a     maze task in which they figure out a path through the maze by walking on the correct squares.     Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.   "
82985|NCT02199795|"     This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos)     and chronic (>6 mos) stroke survivors (n=18 total) with dorsiflexion weakness. The subjects     will be stratified based on interval post-stroke and baseline level of motor impairment and     then randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES)     versus control. The primary objective of this study is to compare the effect of 6-weeks of     lower extremity CCNMES, applied in an anti-phase application, on motor impairment and     functional mobility to a control group; the effect of interval post-stroke, subacute (early)     versus chronic (late) post-stroke, will be assessed. The secondary objective is to determine     the effect of 6-weeks of lower extremity anti-phase CCNMES on functional magnetic resonance     imaging (MRI) cortical activation patterns using an ankle dorsiflexion paradigm. The specific     use of functional MRI as an outcome measure is to explore a central mechanism for     between-group differences.      AIM 1: Determine the effect of lower extremity CCNMES, applied in an anti-phase application,     on motor impairment and functional mobility in hemiparesis compared to a control group;     assess the effect of application in the subacute (< 6 mos, early) versus chronic (> 6 mos,     late) post-stroke period.      Hypothesis: Subjects randomized to the lower extremity CCNMES group will achieve greater     improvement in motor impairment and functional mobility as compared to the control group;     subjects in the subacute post-stroke period will achieve greater improvement than subjects in     the chronic post-stroke period.      AIM 2: Demonstrate change in functional MRI activation patterns using an ankle dorsiflexion     paradigm following the lower extremity anti-phase CCNMES intervention.      Hypothesis: Subjects randomized to the anti-phase CCNMES group will demonstrate change in     functional MRI cortical activation patterns which differs from the control group; subjects in     subacute post-stroke period will demonstrate change in functional MRI activation patterns     that are distinct from change noted in chronic subjects.      AIM 3: Define a central mechanism for post-stroke motor and functional recovery associated     with lower extremity anti-phase CCNMES.      Hypothesis: Change in functional MRI cortical activation patterns following anti-phase CCNMES     intervention will correlate with change in motor impairment and functional mobility.   "
82986|NCT02199782|"     19% of Wales' population speaks Welsh. Under the Welsh Language Act 1993, every public body     providing services to the public in Wales has to prepare a scheme setting out how it will     provide those services in Welsh.      Diagnosing dementia requires a comprehensive assessment, an essential component of which is a     cognitive assessment tool, which takes the form of a questionnaire. In clinical practice,     this is currently only available through the medium of English.      The investigators objective is to measure the difference between Cognitive Assessment scores     (using the Montreal cognitive assessment (MoCA)), when done in English and Welsh, in those     who are cognitively impaired and whose first language is Welsh. The investigators predict     that there will be a significant difference in scores in favour of the Welsh-medium tests,     thus proving that the current mode of administering the test is prejudiced against patients     whose first language is Welsh.      If the investigators predictions are correct, then the investigators would seek to introduce     a validated Welsh-language cognitive assessment tool to the domain of the Welsh NHS.   "
82987|NCT02199769|"     This study will focus on the cohort of 20,000 established patients cared for by 31 attending     physicians in the outpatient, adult primary care practices at UT Southwestern (two general     internal medicine one family medicine and one geriatric practice). The investigators will     develop and implement an automated Diabetes Detection Tool (DDT) that does data mining on     electronic medical record (EMR) lab data to systematically identify all primary care patients     with elevated random plasma glucose results (RPGs) who are at high risk of diabetes and thus     in need of further testing. In a cluster-randomized trial, primary care providers will be     randomized to either the intervention/DDT arm or usual care. Providers in the intervention     arm will receive visit-based, EMR-enabled case identification and real-time decision support.     Outcomes will be tracked at a patient level. All subjects will be followed for 12 months to     assess rates of follow-up diabetes testing, time to testing, rates of subsequent diabetes     diagnosis, and time to diagnosis. The investigators hypothesize that the visit-based provider     decision support will be superior to usual care.   "
82988|NCT02199756|"     The purpose of the study is to find out whether indomethacin encapsulated within a nanovector     can stop contractions in pregnant human uterine tissue. Preterm delivery is a major     contributor to newborn deaths. The treatment of preterm labor includes medications that stop     contractions within the uterus, or womb. Indomethacin is effective in stopping uterine     contractions, but crosses the placenta to the unborn baby causing problems for the baby.     Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered     directly to the uterus using a nanovector, it may be an ideal medication to treat preterm     labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine     contractions.   "
82989|NCT02199743|"     24 individuals with schizophrenia or schizoaffective disorders, who are currently considered     stable, will be recruited, screened for entry criteria into a blinded study with a 4-week     randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related     outcomes with lurasidone as compared to haloperidol and perphenazine.   "
85128|NCT02171767|"     Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4     different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50     mg) administered as single doses to healthy male volunteers   "
82990|NCT02199717|"     This pilot project was developed to investigate subjective and objective data related to the     patterns of physical activity participation among hemophilia patients (FVIII or FIX) between     the ages of 5 and 18 years. Physical activity participation among different levels of disease     severity will be compared using accelerometers to calculate the amount of time spent in     moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally,     data will be collected from two validated questionnaires (PedHAL and 3 day physical activity     recall). Current literature that relates level of physical activity to disease severity in     the pediatric hemophilia population is limited. The information gained about the type and     quantity of physical activity participation in children with varying levels of hemophilia     will assist in the development of education and interventions to promote good physical     activity and potentially examine the role of tailored prophylaxis.   "
82991|NCT02199704|"     The aim of the case series study is to explore if a self directed version of the Positive     Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with     psychosis who are parents.   "
84643|NCT02178111|"     The study hypothesis is that not performing never episiotomies is safe and results are     equivalent to performing episiotomies ina selective manor.   "
82992|NCT02199691|"     The purpose of this trial is to evaluate the immunogenicity and safety of MenACYW conjugate     vaccine compared to those of a licensed product, MENVEO vaccine and also evaluate MenACYW     conjugate vaccine when given alone compared to when given with Tdap vaccine and HPV vaccine.      Primary objective:        -  To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine          when MenACYW conjugate vaccine is given alone compared to those when MENVEO vaccine is          given alone.      Secondary objective:        -  To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine,          when MenACYW conjugate vaccine is given concomitantly with Tdap and HPV vaccines,          compared to those when it is given alone        -  To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap          vaccine is given concomitantly with MenACYW conjugate vaccine and HPV vaccine, compared          to those when Tdap vaccine is given with HPV vaccine only      Observational objective:        -  To describe the safety profile of MenACYW conjugate vaccine, compared to that of the          licensed vaccine MENVEO®, and when MenACYW conjugate vaccine is given with Tdap and HPV          vaccines.   "
82993|NCT02199678|"     This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging,     placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of     ketamine sublingual wafer in adult subjects who experience post operative pain after     undergoing third molar extraction.   "
82994|NCT02199665|"     This phase I trial studies the side effects and best dose of selinexor and carfilzomib when     given together with dexamethasone in treating patients with multiple myeloma that has     returned or does not respond to treatment. Drugs used in chemotherapy, such as selinexor and     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving selinexor, carfilzomib, and dexamethasone may be a better treatment for multiple     myeloma.   "
82995|NCT02199652|"     Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are     already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine     Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators     hypothesize that patients receiving prazosin will have a greater reduction in suicidal     ideation.   "
82996|NCT02199639|"     Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It     aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain,     El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the     degree of injury, age, presence of inhibitors and the development of physical activity;     identify the relationship between the functional deficit by clinical assessment performed     with the use of validated measurement scales, the assessment of the degree of injury to     specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their     impact on gait in patients with hemophilia; and evaluate the factors that influence the     perception of illness and quality of life of patients with hemophilia.   "
82997|NCT02199626|"     This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are     candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and     the second generation of colon capsule in comparison second generation of colon capsule     endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast     ultrasonography (SICUS) and endoscopy (upper and lower).      This study aims        1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the          evaluation of pediatric Crohn's disease.        2. To evaluate the safety of CCE-2 in pediatric CD.   "
82998|NCT02199613|"     The study aims to assess the safety and efficacy of darunavir 800mg plus the co-formulated     elvitegravir/cobicistat/tenofovir disoproxil fumarate (DF)/emtricitabine (Stribild) tablet as     a simplification strategy for the treatment of HIV infection in HIV-infected subjects who     have had previous antiretroviral treatment experience with multiple-drug regimens.      We hypothesize that elvitegravir/cobicistat/tenofovir DF/emtricitabine with darunavir will     offer a safe and efficacious treatment simplification strategy for HIV positive patients     currently receiving multiple-drug regimens to control their HIV infection.   "
82999|NCT02199600|"     This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.   "
83018|NCT02199353|"     To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL)     Occupational Therapy programme on the independence of ADL by persons with dementia who are     institutionalized. This programme is based on the recovery of the cognitive functions.   "
83045|NCT02199002|"     Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of     adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors     (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this     therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not     fully understood, there is currently no adequate therapy available.      It is becoming increasingly clear that reflux, especially in the postprandial period, occurs     from a reservoir of acid floating on top of the meal: the so-called acid pocket. In this     study, we aim to investigate further the acid pocket by determining its exact position and     chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI     therapy and GERD patients with barrett's esophagus.   "
83022|NCT02199301|"     Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been     well-known that long-term IS inevitably causes various complication e.g. infection, toxicity,     diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and malignancies and     so on. Tolerance induction showing graft function without maintenance IS has been considered     as a final solution in the transplantation recipients. Tolerance induction can be achieved in     KT recipients with donor hematopoietic stem cell transplantation (HSCT).      In this study, adult patients (18 and more years of age) with a human leukocyte antigen     (HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for HSCT     1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the time     of nephrectomy for transplantation in donor. Donor BM is infused immediate     post-transplantation at intensive care unit (ICU). Immunologic measurements including     microchimerism study and protocol biopsy will be followed at several time points. IS will be     tapered slowly and withdrawn over a period of several months.   "
83000|NCT02199587|"     The investigators would like to examine the contribution of medical clowns in routine medical     procedures in the endocrine clinic. This will be the first time that will objective evaluate     the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and     also evaluate the effect of mental stress on growth hormone secretion in children.      The aim of the current study is testing the pain and anxiety of the patient and the     accompanying parent and medical staff in the presence or absence of medical clown at the     time:        1. LRH analog (decapeptyl) intramuscular injections for precocious puberty.        2. Growth hormone tests.      Secondary end point will be:        1. Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone          tests in the presence of a clown.        2. Does the presence of a medical clown and the mental stress affect the secretion of          growth hormone?        3. Are there differences in growth hormone secretion and stress hormones between the          various tests for growth hormone secretion (glucagon, clonidine or arginine) in the          presence of a clown?        4. Are there differences in response to stress and the secretion of growth hormone in          children with obesity?   "
83001|NCT02199574|"     The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single     dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for     prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of     the adenoids.   "
83002|NCT02199561|"     Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for     CD patients. Studies are now required to determine if repeated FMT can overcome the apparent     immune response to FMT thereby maintaining sustained clinical improvement and remission.     Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility     study to determine if serial FMTs can sustain a clinical response and maintain stability of     transplanted microbiota.   "
83003|NCT02199548|"     Adolescents with cancer weigh multiple influences in medical decision-making, including their     own best interest, the perceived wishes of family members, and the interpreted preferences of     the health care team. Parents of children with cancer often describe themselves as trying to     be a good parent in making decisions in the child's best interest. Adolescents with cancer     often describe themselves as trying to be a good patient and good child in making decisions     in accord with how they believe a good patient and good child would decide.      Among the challenges of caring for adolescents is the reality that the formative relational     influences in adolescents' decision-making are both complex and unique due to adolescent     patients' social networks and relational roles. Delineating adolescents' definitions of being     a good patient, a good child, a good sibling, and a good friend may enable the care team to     better understand the formative decisional influences relevant to adolescents with cancer.     Expanding knowledge about the decision making constructs relevant to adolescents with cancer     and recognizing the role of these social constructs in medical interactions has the potential     for development of a comprehensive care model that methodically evaluates the self-assessed     decision making influences and needs of adolescents at various stages in oncology care.      This qualitative construct-defining study represents an initial step in the development of     enhanced interventions for improved psychosocial support in this vulnerable population.   "
83004|NCT02199535|"     The aim of the study was to investigate the analysis of the risks faced by the personnel     working in the field of Anesthesiology and Reanimation in Turkey   "
83005|NCT02199522|"     As we know propofol is popular use in the anesthesia induction with kilogram and it always     cause hypotension. So we compare haemodynamic changes and drug consumption between propofol     titrated administration and traditional administration for anesthesia induction.   "
83006|NCT02199509|"     Background:      - People with dystonia cannot control their muscle contractions. This disorder can affect     different body areas. When it affects the face, tongue, and jaw, it is called oromandibular     dystonia (OMD) or cranial dystonia (CD). Researchers want to find out if a drug that treats     seizures may help people with this kind of dystonia.      Objective:      - To see if levetiracetam can improve symptoms of jaw or face dystonia.      Eligibility:      - Adults ages 18 to 80 years with OMD or CD.      Design:        -  Participants will be screened with a medical history and physical exam. Researchers will          test how severe their dystonia is.        -  Participants will have blood drawn through a needle in the arm.        -  Participants will be assigned to take either levetiracetam or placebo.        -  Phase 1:        -  Participants will start with one 500-mg tablet twice daily. The dose will be increased          by 500 mg every 3 days. The maximum dose will be 4000 mg a day over 3 weeks.          Participants who cannot tolerate that will take the highest dose they can.        -  Participants will return for study visits at weeks 3 and 6. They will be asked about          their health, side effects, and symptoms of depression. They will have a neurological          examination and test of their dystonia.        -  After the week 6 visit, participants will taper and stop the study drug over about 1          week.        -  Phase 2 begins one week later. Participants will repeat phase 1, but with the other          drug.        -  After phase 2, participants will return to their usual clinics. They will be told how to          stop taking the drug. They will have a follow-up phone call 2 weeks later.   "
83019|NCT02199340|"     The progression of lung disease in cystic fibrosis (CF) results inevitably in a reduction in     exercise capacity. The assessment of fitness and exercise capacity in CF is an important     measure of the impact of the disease process, particularly if it is repeated over time. With     recent advances in clinical management, CF lung disease in children can be relatively mild     and exercise tolerance good. The currently available field tests e.g. 3 minute step test, are     often completed too easily. These tests provide limited information relating to maximal     exercise performance. By contrast, the maximal CardioPulmonary Exercise Test (CPET), a     progressive, incremental, gold standard exercise test with breath by breath analysis of     expired gas, has proved to be a valuable means of assessing exercise response in patients     with CF. Its only limitation is the requirement for specialist laboratory facilities,     equipment and staff.      A new field test for evaluating exercise capacity in children is needed. This should be     portable, easy to administer and simple to perform by young children, while providing a     higher intensity of exercise which correlates with day to day activity patterns of children,     and clinically relevant information in the short term and longitudinally. This test needs to     be a good surrogate measure of exercise capacity when formal CPET is unable to be undertaken.     By providing accurate and useful information the results can be used to prescribe and train     individuals with CF safely and effectively and can also be used in the short and long term     for guidance of the medical management of these complex patients.      The aim of this study is to develop and validate the use of a new incremental step test to     assess exercise tolerance/capacity in children with CF, compare this with the gold standard     CPET and to provide normative healthy control comparison data The main objectives of the     study are        1. To develop an incremental step test to assess exercise tolerance / capacity in children          with CF.        2. To compare the incremental step test with the gold standard CPET        3. To assess the level of exercise response produced by the incremental step test        4. To assess the correlation between independent variables of lung function measurements,          age, weight and height with VO2peak and other exercise test outcomes        5. To assess the repeatability and evaluate the normal variability of the new incremental          step test        6. To provide healthy control normative data for comparison   "
83007|NCT02199496|"     Background:      - Some people with Common Variable Immunodeficiency Disease (CVID) have gastrointestinal     inflammation. This can cause diarrhea, weight loss, and not being able to absorb nutrition     from food. Researchers want to see if the drug ustekinumab can help these problems. This drug     blocks some proteins that cause inflammation.      Objective:      - To test the safety and efficacy of the drug ustekinumab for people with CVID with     gastrointestinal inflammation.      Eligibility:      - Adults ages 18-75 with CVID. They must have chronic diarrhea, have unintentionally lost     weight in the last year, and/or need to use nutritional supplements to maintain their weight.      Design:      Participants will undergo the following screening studies to make sure that this study is a     good fit for your medical situation, and to make sure it is safe for you to receive the study     medications tests, including tests for HIV and hepatitis . This will be done as an inpatient     at the NIH Clinical Center and takes about 5-6 days:        -  Participants will be screened with:        -  Medical history        -  Physical exam        -  Blood tests, including tests for HIV and hepatitis.        -  Stool tests, including a timed 48 hour collection for fat malabsorption and a 24 hour          collection for protein malabsorption        -  Urine tests, including a pregnancy test for any women with the ability to have a child        -  Chest CT scan to look for infection        -  D-xylose testing, which involves drinking a sugary solution and then having a blood          sample drawn to test carbohydrate (sugar) malabsorption        -  Hydrogen breath testing for test for small intestinal bacterial overgrowth (SIBO) this          test also involves drinking a sugary solution and then collecting breath samples        -  Upper endoscopy (EGD) and/or colonoscopy to look at the lining of the GI tract and take          biopsies for testing. This will be done under sedation by a qualified          gastroenterologist.      Participants who complete screening and meet all criteria will then return to the NIH     Clinical Center for the following visits:        -  First Treatment Visit (1 clinic day): Medical history, physical exam, measurement of          vital signs and weight, review of medications, and an assessment of number and          consistency of stools each day. A pregnancy test for women of childbearing potential. A          nurse will give you three shots of 90 mg ustekinumab (270 mg total dose) by very small          needles injected under the skin, and then observe you for 1 hour.        -  Week 8 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of          vital signs and weight, review of medications, and an assessment of number and          consistency of stools each day. Blood, urine and stool samples will be collected. A          pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose          of ustekinumab by a very small needle injected under the skin, and then observe you for          1 hour.        -  Week 16 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of          vital signs and weight, review of medications, and an assessment of number and          consistency of stools each day. Blood, urine and stool samples will be collected. A          pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose          of ustekinumab by a very small needle injected under the skin, and then observe you for          1 hour.        -  Week 24 Treatment and Mid-point Evaluation Visit (4-6 inpatient days): Medical history,          physical exam, measurement of vital signs and weight, review of medications, and an          assessment of number and consistency of stools each day. Blood, urine and stool samples          will be collected, including repeating the d-xylose carbohydrate malabsorption testing,          the 24 hour stool collection for protein malabsorption and the 48 hour stool collection          for fat malabsorption. A pregnancy test for women of childbearing potential. A nurse          will give you one 90 mg dose of ustekinumab by a very small needle injected under the          skin, and then observe you for 1 hour.        -  Week 32 Treatment Visit: Medical history, physical exam, measurement of vital signs and          weight, review of medications, and an assessment of number and consistency of stools          each day. Blood, urine and stool samples will be collected. A pregnancy test for women          of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very          small needle injected under the skin, and then observe you for 1 hour.        -  Week 40 Treatment Visit: Medical history, physical exam, measurement of vital signs and          weight, review of medications, and an assessment of number and consistency of stools          each day. Blood, urine and stool samples will be collected. A pregnancy test for women          of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very          small needle injected under the skin, and then observe you for 1 hour.        -  Week 48 ...   "
83008|NCT02199483|"     Background:      - Many people can lose weight by changing their diet or exercise. However, most people     eventually regain the weight over time. This weight regain may be related to changes in     metabolism as well as changes in the brain caused by weight loss. Researchers want to learn     more about these changes.      Objective:      - To see how weight loss and regain affects the body s metabolism and the brain of obese but     healthy adults.      Eligibility:      - Obese but healthy adults age 18-55 who plan to participate in a weight loss program at one     of several participating clinics or resorts.      Design:        -  Participants will first be screened at home through questionnaires and telephone          interviews.        -  Participants will then be screened at the NIH with blood tests, medical history,          physical exam, electrocardiograms, and questionnaires. They will have a mock magnetic          resonance imaging (MRI) scan.        -  At visit 1, participants will stay at the NIH and will:        -  have MRI and PET brain scans.        -  have body composition scans and measurements.        -  give blood samples.        -  eat a special diet.        -  wear a physical activity monitor.        -  provide a urine sample and body weight daily.        -  drink a special type of water to measure calorie burn.        -  wear a clear plastic hood over their head while lying down, to collect exhaled air.        -  spend 24 hours in a room that measures oxygen and carbon dioxide.        -  complete questionnaires and computer tasks.        -  After visit 1, participants will give daily urine samples and weight and physical          activity measurements from home. Then they will follow a lifestyle intervention for          weight loss and give daily weight and activity measurements.        -  Visits 2, 3, and 4 occur 1-26 months after the start of the weight loss program.          Participants will repeat procedures from visit 1. Visits 1-4 last 4 days each.        -  Researchers will track participants weight and physical activity for up to 26 months          after visit 2.   "
83009|NCT02199470|"     Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve     glycemic control and decrease complications and rates of mortality. However, it can be     succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of     β-cell function by determining fasting levels of C-peptide and those after meal stimulus.   "
83010|NCT02199457|"     A medical device study to assess the clinical accuracy and equivalence to reference devices     of the SVSS to satisfy the requirements of the recognised applicable international standards.     The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen     saturation (Sp02), blood pressure, body temperature and respiration rate. These results will     be compared for accuracy with the results obtained using standard vital sign measurement     equipment on the same subject.   "
83011|NCT02199444|"     The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by     resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease     (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly     demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in     vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our     study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.   "
83012|NCT02199431|"     The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a     single oral dose of Lu AF11167 with and without administration of multiple oral doses of     itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status     as CYP2C19 extensive metabolisers   "
83013|NCT02199418|"     The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based     regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast     cancer.   "
83014|NCT02199405|"     The incidence of cervical spondylosis on young people is increasing every year. Suffering     from this disease will affect the normal life and learning of young people. Episode younger     and incidence higher of this disease could increase health care spending of the government in     the economy. Cervical spondylosis of cervical type is the main type of cervical spondylosis     of young people. Patients of cervical spondylosis of cervical type always manifest the head,     neck and shoulder pain accompanied by corresponding pressure point, the X-ray display of     Upper cervical curvature change and instability of intervertebral joint performance ,and the     dynamic lateral X-ray shows vertebral instability or trapezoidal change. The conservative     treatment is the primary and preferred treatment of the disease.      This study is designed as a random, control, single blind study. It will recruit 140 cases of     cervical spondylosis of cervical type. Both the treatment group and the control group will be     randomly assigned 70 cases. Patients in the treatment group will be treated by Massage of     chiropractic and adjusting cervical curvature and practice Sishi Daoyin for 4 weeks，and the     control group by conventional massage and cervical traction. The total study includes 2 views     that are baseline and post-4week intervention. At all of the 2 views, all participants will     be examined range of motion of cervical vertebra, cervical curvature, and Surface     Electromyography of neck muscles, and will be estimated scores of The Neck Disability     Index(NDI), the Northwick Park Neck Pain Questionnaire (NPQ),Short-form McGill Pain     Questionnaire(SF-MPQ) and Evaluation of the therapeutic effect. This study aims to     investigate the efficacy of Massage of chiropractic and adjusting cervical curvature and     Sishi Daoyin practice, and discover the correlation between these scales and these objective     indicators to discover the indicators of early warning signs of cervical spondylosis of     cervical type of young people.   "
83015|NCT02199392|"     The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy     subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and     P-glycoprotein induction on lenvatinib pharmacokinetics following single dose oral     administration of 24 mg lenvatinib to healthy volunteers.   "
83016|NCT02199379|"     The purpose of this multicenter, open-label, non-randomized, single, oral dose,     sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg)     administered to healthy subjects and to subjects with renal impairment.   "
83017|NCT02199366|"     This is a pilot study to determine if there are changes in heart function following     completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance     imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side     effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and     compare quality of life questionnaires.   "
83025|NCT02199262|"     Agitation in the intensive care unit can have multiple consequences. The investigators     hypothesize that agitation and its consequences can be reduced by the introduction of a     reminder aiming at guiding the management of agitation. The investigators also hypothesize     that they can prevent agitation and its consequences by acting on patients environment with     reafferentation and relaxation methods.      The investigators' objectives are to test within a quality improvement project by a     prospective randomized study:        -  If by reducing the number of agitation episodes we reduce the number of harmful          consequences.        -  If the introduction of reafferentation and relaxation methods (music therapy or          reflexology) can prevent the occurrence of agitation.        -  If the introduction of a reminder on management of agitation can reduce the number of          agitation episodes.      This study is conducted in an18 general surgical ICU beds receiving 1600 patients / year for     a total of 6900 hospital /days /year, in a tertiary teaching hospital.      The study is organized in 3 phases:        1. First phase: Baseline phase (Prospective analysis of the present situation)        2. Second phase: Learning phase (Implementation of a reminder about the management of          agitation and delirium )        3. Third phase: Randomized Intervention (reminder alone vs addition of music or          reflexology)      The interventions are :        1. Implementation of a reminder of guidelines of agitation diagnosis and management.        2. Music intervention( see description below) + reminder        3. Reflexology (see description below)+ reminder      Agitation is monitored with two scales SAS and CAM-ICU(description below) . Harmful     consequences and complications are systematically registered as well as medication and the     use of contention methods.      Adherence to the implemented monitoring and interventions is also regularly checked.      Data are daily collected (see details below) Statistical analysis and power calculation (see     below)   "
83026|NCT02199249|"     Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is     assumed to disrupt the syndesmotic ligaments.      The goal of operative treatment is to reduce the ankle mortise to restore normal joint     kinematics. Syndesmosis repair can be performed using either open or closed reduction,     combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated     high rates of non anatomic reductions greater than 40%; therefore, open reduction will be     performed in this study. Screw fixation is stable but concerns exist regarding potential     excess rigidity.      Recently, flexible fixation techniques combined with anatomic reduction have demonstrated     improvements in functional outcomes and reduction quality. Both open reduction and flexible     TightRope fixation have considerable support in the literature in cohort studies but have not     been compared to open screw fixation in a randomized controlled trial.      In this multi centre randomized study, radiographic, economic and functional outcomes are     compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open     reduction screw fixation (OS)] of the syndesmosis.   "
83027|NCT02199236|"     The purpose of this study is to see what amount of radiation is safe to give to rectal or     anal cancer patients who are being treated with a procedure called brachytherapy.   "
83028|NCT02199223|"     Evaluate the safety of regorafenib and panitumumab   "
83029|NCT02199210|"     The purpose of the project is to investigate the function of self-regulatory processes in     anesthesiologists and how application of these processes influence performance in a crisis     situation.The investigators intend to explore specifically the first phase of     self-regulation, i.e. the forethought phase which describes processes related to strategic     planning, goal setting, goal orientation, and outcome expectation. The investigators     hypothesize that prompting forethought before engaging in a simulated massive transfusion     crisis situation will result in better task performance in anesthesiologists.   "
83030|NCT02199197|"     Study of Radium Ra 223 dichloride with enzalutamide compared to enzalutamide alone in men     with metastatic castration refractory prostate cancer   "
83031|NCT02199184|"     The goal of this clinical research study is to learn if adding ofatumumab/rituximab to the     standard combination of DA-EPOCH (dose-adjusted etoposide, prednisone, vincristine, and     cyclophosphamide) can help control the disease in patients with newly diagnosed or     relapsed/refractory Burkitt leukemia or relapsed/refractory ALL. The safety of this drug     combination will also be studied.   "
83032|NCT02199171|"     This phase I trial studies the side effects and best dose of heated carboplatin given into     the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian     tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it     directly into the area around the tumor during surgery may kill more tumor cells.   "
83033|NCT02199158|"     Purpose:      To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to     report its complications at 1-week and 1-month follow up in patients that did not achieve a     satisfactory clinical angle opening despite patent laser peripheral iridotomy.      Design:      Prospective, Interventional case series      Subjects:      Patients with an occludable angle in more than two quadrants in dark room indentation     gonioscopy and patent iridotomies of at least 2 weeks, with assessment of persistent angle     closure aetiology by ultrabiomicroscopy and A-scan ultrasound are included.      Patients will undergo complete examination and AS-OCT before ALPI, one week and one month     after it. We analyzed the images in a masked manner and took the angle measurements (AOD500,     AOD 750, TISA500, TISA750, ARA500, ARA 750, Lens vault) at 0° and 180° as the main outcome     measure to determine effectiveness.   "
83034|NCT02199145|"     Membranous Nephropathy (MN) is an auto-immune kidney disease and a common cause of nephrotic     syndrome. About 30% of MN patients progress to end-stage kidney disease (ESKD) while 30%     undergo spontaneous remission. The phospholipase A2 receptor (PLA2R1) is the major     auto-antigen in idiopathic MN. Anti-PLA2R1 autoantibodies are found during the active phase     of MN. Predictors of disease progression include high titers of anti-PLA2R1 autoantibodies     and serum creatinine levels at presentation, as well as decline in renal function during the     first six months of follow-up. Investigators identified new prognostic factors in a cohort of     41 idiopathic MN patients with nephrotic syndrome and anti-PLA2R1 autoantibodies at the time     of presentation. During a follow-up of at least 36 months, 21 patients had a persistent     nephrotic syndrome (group A) and 20 showed partial or total remission (group R). We first     measured the cross-reactivity of their sera at the time of presentation to human, rabbit and     mouse recombinant PLA2R1 by western blot. All patients exhibited reactivity against human and     rabbit PLA2R1, but only some of them did against mouse PLA2R1. These results suggest the     presence of distinct epitopes that are differentially conserved among PLA2R1     orthologs.Investigators then set-up three parallel ELISAs using human, rabbit and mouse     recombinant PLA2R1. All 41 MN patients showed activity in human and rabbit ELISAs at     presentation but only 32 of them (78%) in mouse ELISA.They finally analyzed the association     between anti-PLA2R1 titers at presentation in the different ELISAs and the subsequent     clinical outcome. The mean anti-PLA2R1 activity was significantly different between group A     and R in mouse ELISA but not in human and rabbit ELISA. Patients with anti-mouse PLA2R1     activity over 605 RU (relative unit)/ml showed a significantly lower survival without     doubling of serum creatinine or ESKD , but patients in the highest tertile of anti-PLA2R1     activity in rabbit and human ELISA did not show a significant increased risk of renal failure     progression. The results suggest that the specific detection of particular anti-PLA2R1     autoantibodies using the novel anti-mouse PLA2R1 ELISA can identify MN patients at risk for     ESKD. The aim is to confirm these result on a prospective cohort.   "
83035|NCT02199132|"     Retrospective study of patients diagnosed with a nasopharyngeal carcinoma included in our     data base care between June 1990 and September 2013.      Our hypothesis is:      Our series of patients with a history of nasopharyngeal carcinoma presents epidemiological,     response rates to the different treatments and survival similar to those described in the     literature   "
83040|NCT02199067|"     Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for     permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the     volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total     intravenous anaesthesia with propofol is done only by experience of the anaesthetist or     according to pharmacokinetic models. In this study we want to investigate if the exhaled     fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled     propofol will be measured with an electrochemical sensor developed by Drägerwerk AG & Co.     KGaA. Exhaled propofol levels will be compared with the corresponding arterial serum     concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol     levels with the Bispectral Index (BIS).   "
83041|NCT02199054|"     This research study is being done to help researchers develop new dietary options for     menopausal women to maintain a healthy weight by developing more nutritious snacks that have     health benefits. From this study, the researchers hope to gain understanding on how     menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its     own and when combined with soy. The research team hypothesize that the two different types of     pretzels may be processed by your body differently and that components in the pretzel snacks     may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans     contain many natural chemicals that may benefit human health. However, this relationship is     not well understood. This study will look at the impact of the pretzel snacks on your blood     fat and glucose levels as well as a group of chemicals found in soy called isoflavones.     Isoflavones are natural chemicals found commonly in soybeans or foods made from them.      Participants will be screened to determine if they qualify in meeting the study requirements.     Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein.     Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts     and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The     study will require five visits to the Ohio State University Clinical Research Center (CRC)     which part of the Ohio State University's Center for Clinical and Translational Sciences.     Once the investigators have determined that you qualify for this study and you decide to     participate, you will be consuming three different pretzels each for one month, starting with     a control pretzel. After the control pretzel treatment period, you will be randomly assigned     (like the flip of a coin) to start with one of the two pretzel groups (wheat or soy pretzel     with safflower oil) for your first treatment period and then switch to the other safflower     oil pretzel at your second treatment period.   "
83042|NCT02199041|"     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched     related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin     receptors (KIR) ligand mismatched haploidentical donor identified, will receive a combined T     cell depleted (TCD) haploidentical peripheral blood stem cell (PBSC) and unrelated umbilical     cord blood transplantation (UCBT) using a total lymphoid irradiation (TLI) based preparative     regimen.      Primary objective:        -  To estimate the incidence of donor derived neutrophil engraftment by day +42          post-transplant for participants with high-risk hematologic malignancies undergoing a          total lymphoid irradiation (TLI)-based hematopoietic cell transplantation (HCT) using a          T cell depleted (TCI) haploidentical donor peripheral blood stem cell (PBSC) donor          combined with an unrelated umbilical cord blood (UCB) donor.      Secondary objectives:        -  Estimate the incidence of malignant relapse, event-free survival (EFS), and overall          survival (OS) at one-year post-transplantation.        -  Estimate the incidence and severity of acute and chronic graft versus host disease          (GVHD) in the first 100 days after transplantation.        -  Estimate the incidence of secondary graft failure transplant related mortality (TRM) and          transplant related morbidity in the first 100 days after HCT.   "
83043|NCT02199028|"     This research study examines the effect of hyaluronidase on the length of time of insulin     infusion set wear. The aim of the study is to improve the length of time that an infusion set     can be worn by infusing hyaluronidase directly into the insulin infusion site. The     investigators will also assess the accuracy of the Dexcom G4 Platinum (G4P) sensors with     extended sensor wear beyond the 7 day FDA approved time frame.   "
83046|NCT02198989|"     40 patients with Type 2 Diabetes Mellitus who also have sleep disorders and mild depression     in the community will be recruited and stochastically divided into the intervention group and     the control group. Both groups will take the same group education courses including DSME     (Diabetes Self-management Education), psychological support, improvement in sleep. Patients     in the intervention group will receive peer support and yoga music therapy before bed. The     observation period will last for 6 months so as to evaluate the benefits of peer support and     yoga music therapy in sleep quality improvement and glycemic control of type 2 diabetic     patients with sleep disorders and mild depression.   "
83047|NCT02198976|"     The purpose of this study is to collect prospective observational data regarding endoscopic     management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia     and/or intramucosal carcinoma. To observe the natural history of patients with low grade     dysplastic and non dysplastic Barrett's oesophagus   "
83048|NCT02198963|"     The purpose of this study is to determine the skin irritation potential of RUT058-60 after     repetitive patch application to abraded and non-abraded skin of human subjects.   "
83049|NCT02198950|"     The purpose of this study is to determine wether the combined measurement of the soluble form     of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in     critically ill patients.   "
83050|NCT02198937|"     Investigation on the effect of smoking on thrombus formation in humans. The expression of     pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50     year old healthy smokers and non-smokers. The investigators are interested in possible     differences between the two groups.   "
83075|NCT02198612|"     Over the past years, arterial closure systems have tended to replace manual compression to     ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce     hemostasis and patient immobilization times, thus enabling early resumption of walking. These     devices have contributed extensively to the development of outpatient stays for cardiology,     vascular and neuro-radiology procedures.      According to certain studies however, it would appear that arterial closure devices do not     present any greater benefits than manual compression in terms of hemostasis and     complications. Moreover, the use of increasingly small diameter instruments would tend to     render manual compression sufficient. Finally, the use of these devices generates additional     costs.      The purpose of our study is to evaluate the feasibility and safety of manual compression     before early resumption of walking in patients managed by conventional hospitalization for a     diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F     guide catheter.   "
84644|NCT02178098|"     This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo     in patients with hypercholesterolemia and hypertension.   "
83051|NCT02198924|"     In mainland China, knee Osteoarthritis (OA) is the leading cause of disability in older     persons. Total knee arthroplasty (TKA) is now generally regarded by orthopaedic surgeons and     patients as an effective treatment for end-stage knee OA in order to relieve pain, correct     joint deformity and improve the life quality of patients.However, TKA has been called as one     of the most painful Orthopedics surgery due to the weight bearing characteristics of knee     joint and the high demand of functional exercise within the 6-8 weeks post operation. The     targeted application of selective cyclooxygenase (COX) -2 inhibitor, such as Parecoxib or     Celecoxib, can significantly reduce the level of inflammatory reaction one and two days     postoperation . In addition, the perioperative administration of Celecoxib can directly or     indirectly relieve postoperative pain, improve articular function and eventually augment life     quality of the patients . Recently, effective treatment of post-operative pain with     intravenous followed by oral COX-2 specific inhibitor has been demonstrated in many     post-operative pain models . Significant morphine sparing effect and reduction of opioid     distressed symptoms were also observed. In China, many surgeons have accept it as a routine     strategy for controlling pain post TKA to sequentially give parecoxib 40 mg intravenously     twice daily for the first 3 days post surgery and then Celecoxib 200mg orally twice daily.     Although satisfactory results of this combination treatment on short-term pain reduction and     functional improvement has been observed in clinical practice, high quality evidence is still     lacking to prove its effect on the medium or long-term functionality recovery. This study is     being conducted to investigate the combination regimen with intravenous parecoxib followed by     oral celecoxib for post-surgical analgesic treatment in osteoarthritis patients undergoing     total knee arthroplastic (TKA) surgery. Subjects will receive double-blinded study medication     consisting of parecoxib injection in analgesic doses or matching placebo followed by oral     celecoxib in acute pain doses or matching placebo in a double-blinded fashion. The hypothesis     is subjects treated with parecoxib/celecoxib will consume less morphine over the first 24     hours of postoperation period, achieve improved pain control over study period, a quicker     return to functionality, and has less opioid adverse events than those treated with opioids     alone over 6-week recovery phase.   "
83052|NCT02198911|"     The purpose of this study is to examine if chewing gum before an eating bout will increase     the rate of habituation and subsequently reduce energy intake within the eating bout.   "
83053|NCT02198898|"     This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea     and the investigators hypothesized applying of adhesive preventing agent would reduce     incidence of adhesive obstruction after gastrectomy.   "
83054|NCT02198885|"     The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch     Technologies) provides a means of transmitting ultrasound images, video, and audio to a     remote location in real-time. It has been envisioned that this system be used to diagnose     trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal     blockage during prehospital care; under the guidance of in-hospital physicians, paramedics     would perform an Focused Assessment with Sonography for Trauma (FAST) examination while     trauma patients are transported to hospital via ambulance. The investigators hypothesize that     in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma     patients' transportation to hospital will reduce time to diagnosis; thus, preparations by     emergency physicians, surgeons, and operating room teams to receive critically injured     patients may begin earlier, reducing time to intervention during a critical period in patient     care. Data will also be collected regarding quality of images obtained in-ambulance and the     interaction between paramedics and physicians using the remote-presence system.   "
83055|NCT02198872|"     In the pathophysiological process of coronary artery disease (CAD), are present, autonomic     dysfunction and reduced functional capacity. Studies showed that physical training (PT) is     critical in the treatment of CAD by promoting beneficial effects. Although water based     exercises program have been documented in patients with various cardiovascular diseases, the     most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To     evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic     modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables     in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by     coronary angiography showing obstruction greater than 50% and underwent angioplasty will be     evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body     composition analysis and recording of HR and NN intervals during rest. 2) The components of     step 1) will be repeated after three month, adding the record of HR and NN before, during and     after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers     will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of     step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote     beneficial physiological adaptations in CAD patients with obstruction greater than 50%.   "
83056|NCT02198859|"     Laboratory testing has suggested that lithium may decrease the incidence of certain types of     cancer, including prostate cancer. Additional research has suggested that lithium decreases     prostate cancer tumor size over time. This study will investigate the effect of lithium on     men with prostate cancer.   "
83071|NCT02198664|"     This is a multi-center, open-label, follow-on study to gather additional information on the     safety and tolerability of oral desensitization with CPNA in the subjects who participated in     ARC001.   "
83057|NCT02198846|"     Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type     2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents.     Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does     not only have efficacy in glucose control but also restore beta cell failure.      The investigators plan to compare the efficacy/safety and beta cell function between insulin     pump treatment and the intensification of conventional treatment in patients with     uncontrolled type 2 diabetes.   "
83058|NCT02198833|"     The purpose of this study is to determine if the study Foley catheter with its patterned     external surface can delay the time to the onset of urinary tract infection in spinal cord     injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.   "
83059|NCT02198820|"     Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital     between October 1th 2014 and September 30th 2015.      Comparison of severity scores of these patients and the scale of Nottingham on immediate (day     1 and day 2) and late (1 month) outcome.   "
83060|NCT02198807|"     The objective of this study is to explore the role of fosmidomycin and piperaquine as     non-artemisinin-based combination therapy for acute uncomplicated Plasmodium falciparum when     administered over three days.      Together, fosmidomycin and piperaquine fulfil the WHO criteria for combination therapy by     meeting the three key parameters of having different modes of action and different     biochemical targets while exhibiting independent blood schizonticidal activity. Like the     artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active     against existing drug-resistant parasites. Piperaquine has a long half life protecting     fosmidomycin as a much shorter lived molecule against selection of resistant parasites and     will provide post-treatment prophylaxis.   "
83062|NCT02198781|"     This is a pilot study into the effects on heart function when pacing the right ventricle     (RV). This study aims to enrol a population who are clinically indicated to receive a     pacemaker.      When normal conduction within the heart fails, the treatment may be to implant a permanent     pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical     impulse to stimulate a beat.      Increasingly the available evidence suggests that long term RV pacing is associated with     complications - left ventricule (LV) dysfunction, heart failure, atrial fibrillation (AF) and     death in some patients. What we do not see are a large proportion of all patients who receive     pacemakers suffering pacing related adverse effects.      If there could be a way of identifying those patients in the group who go on to develop     pacing induced cardiomyopathy at the time of initial pacing implant, this would be a very     valuable clinical measure. These patients could be identified from the outset and paced with     a biventricular device to avoid the pacing induced cardiomyopathy. Whilst much energy has     been directed towards the LV as a focus of the clinical markers of disease, little has been     published looking at RV haemodynamics.      We plan to study a cohort of patients who are clinically indicated to receive a pacemaker and     study their RV in detail at the time of implantation. We will use conductance catheters and     echocardiography to determine measures of pumping function. We will then follow them up for a     period of six month using echocardiography and blood markers of heart dysfunction. In those     patients who have a reduction in heart function we will then look for common patterns within     their initial measurements.   "
83063|NCT02198768|"     The purpose of this study is to compare outcomes of patients with an ankle fracture to those     with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for     patients sustaining ankle fracture dislocations are poorer than those without dislocation.   "
83064|NCT02198755|"     The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the     diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of     HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.   "
83065|NCT02198742|"     The study is a randomized crossover study where anesthesia practitioners will intubate three     different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome     anatomy) using three different intubation devices (the Miller blade, the Truview VL, the     Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an     immobile neck). The order of presentation will be randomized. As this is a cross over study,     all subjects will complete all scenarios. There is no placebo group, and each subject wil be     his or her own control.   "
83066|NCT02198729|"     The investigators have recently become proficient in a new, and we believe more effective     technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves     removing the polyp in one piece. It is preferable to remove the polyp in one piece as it     minimises the chance of leaving residual polyp tissue behind. There have also been recent     studies overseas that have shown this new technique to be quite effective. In this study,     half of the patients will receive the newly developed technique of polyp removal (ESD), while     the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This     study will allow us to show which technique results in lower recurrence rates and is more     effective.   "
83067|NCT02198716|"     The treatment of complex coronary disease causing limiting symptoms of angina with     drug-eluting stent technology will prove superior to bare metal stent technology, with     respect to a combined endpoint of mortality, MI, requirement for target vessel     revascularisation and severe haemorrhage, in patients aged 80 or above.   "
83068|NCT02198703|"     This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic     blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.   "
83069|NCT02198690|"     The aim of this study is to test whether an educational pamphlet on mammography designed for     women aged 75 and older improves older women's decision-making around mammography screening.     The investigators aim to show that the educational pamphlet improves older women's knowledge     of the pros and cons or screening and leads to fewer women in poor health with short life     expectancy being screened.   "
83070|NCT02198677|"     The aim of the investigators study is to investigate whether posteriorly directed (AP)     pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation     or lowering in patients with neck pain. The answer will advance the investigators     understanding of why manual therapy works.   "
83073|NCT02198638|"     Hospital acquired influenza is associated with significant morbidity and mortality in     hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent     influenza transmission in healthcare setting.      Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in     patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in     the elderly population will not necessarily result in a total control of the incidence.     Consequently, the prevention of influenza outbreaks in this vulnerable population must also     include the reduction of the exposure to the influenza viruses, in particular thanks to the     vaccination of HCW.      A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University     hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital     acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results     suggest a protective effect but investigations, carried out on a more important sample are     needed to validate the benefit of HCW vaccination.      The aim of this prospective multicentric cohort study is to estimate incidence of influenza     among hospitalized patients according to % of influenza vaccination of HCW in short stay     units.   "
83074|NCT02198625|"     The purpose of this study is to determine the influence of moderate FiO2 and the lung     protective ventilation on postoperative pulmonary complications following hepatic resection     surgery.   "
83085|NCT02198482|"     Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) in     Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid     Leukemia (AML)   "
83391|NCT02194452|"     This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission     tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients.     Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and     diagnose brain tumors.   "
83076|NCT02198599|"     Objectives: This parallel RCT investigated the effect of a new nursing intervention (Mobility     Enhancing Nursing Intervention - MFP) designed to improve the rehabilitation programs'     outcomes and patients' quality of life.      Intervention: The IG combined standard care with the 30-day mobility-enhancing-nursing     intervention (MFP). MFP placed patients on a mattress on the floor and used constant     tactile-kinaesthetic stimulation in everyday tasks to increase spatial orientation, to teach     patients to get up safely and to move independently.      Primary and secondary outcome measures: Outcomes were defined as functionality (Extended     Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I).   "
83077|NCT02198586|"     The purpose of this study is to investigate the influence of the APOE genotype on brain     morphology, function and metabolism, related to other factors such as cognitive reserve,     cognition and episodic memory, in subjects at greater risk of developing AD.   "
83078|NCT02198573|"     -  Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin          resistance containment measures have been launched since 2009-2010.        -  It is important to monitor the spread and magnitude of artemisinin resistant malaria in          Myanmar.        -  So, day-3 surveillance study have been conducted.        -  Recently artemisinin resistant molecular marker, K13 have been identified and it was          used as a tool in this study.   "
83079|NCT02198560|"     The primary objectives of the study are to assess the agreement between the two different     scan mode of the RS-3000 Lite.   "
83080|NCT02198547|"     The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time     and can enhance offset time.   "
83081|NCT02198534|"     A) For the investigation of Visual acuity, inter-test agreement and the test-retest     reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart     and Freiburg Visual Acuity Test (FrACt). The examinees passed each visual acuity test twice     but the sequence of the visual acuity tests were randomize and so different for each     examinee. The examinees were 24 adult Aalen university students (except students of     ophthalmic optics in terms 2 - 7) with a minimal distant visual acuity without or with     correction of 0.2. Another inclusion criteria was a maximum myopia of sph -2,00 dpt, a     maximum hyperopia of sph +5,50 dpt and a maximum astigmatism of cyl 2,50 dpt. The Landolt C     was projected in eight-orientations. For the FrACT Test we used two different devices for     response input: a modified keypad with Landoltring symbols (FrACTk) and a haptic Landolt     device with an adjustable Landoltring (FrACTh). The primary objective was the comparison     between FrACTk and FrACTh. The secondary Objective contains the comparison between all visual     acuity tests.      B) Background: Landolt Cs and letters are commonly used optotypes. In the explorative study     we compare four different ways of applying them: The Freiburg visual acuity test (FrACT)     using a keypad and a haptic Landolt device, a Landolt C chart in accordance to ISO 8596 and     DIN 58220 with eight-orientated Landolt C and ETDRS charts. The aims of the survey were to     determine examinee´s/examiner´s subjective ratings using Visual analogue scales (VAS), the     inter-test agreement between the tests and test-retest reliability of the tests, concerning     the test duration.      Subjects and Methods: Twenty-four adult examinees with a visual acuity of ≥ 0,2 were included     in the explorative study. The visual acuity of one eye was measured monocularly, randomized     with regard to the leading/non-leading eye. The subjects passed every visual acuity test     twice in a randomized sequence of the visual acuity tests, which is maintained by a     pre-specified randomization list, making use of forced choice.   "
83082|NCT02198521|"     Title Staged Bilateral Carpal Tunnel Release: Which Side Hurts More? Primary null hypothesis     Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in     overall pain intensity of pain between sides.      Secondary null hypotheses        -  There is no correlation in overall pain intensity after open CTR surgery and distal          sensory latency, distal motor latency, electromyography (EMG), demographics, occupation,          avocation, relevant comorbidities, dominance, left vs. right, Pain Self-Efficacy,          Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity or          PROMIS depression when both surgeries are performed within 6 months.        -  There is no difference in satisfaction with treatment at the time of suture removal          after the first and second open CTR surgery when both are performed within 6 months..      IRB: 2009-p-001-019 ClinicalTrials.gov: Not mandatory, (b/o observational) Authors:     Drijkoningen, Braun, Ring Journal: To be discussed Design: Prospective cohort study     Background Many hand surgeons note that patients undergoing staged bilateral open carpal     tunnel release often experience more pain with the second side. The investigator felt this     was an easily testable hypothesis worthy of study.      Subjects      Eligibility:      Inclusion:        -  Age 18 or older        -  Idiopathic carpal tunnel syndrome        -  No prior surgery for carpal tunnel syndrome      Exclude:        -  Pregnant women        -  Not fluent in English      Response Variables:        -  11-point ordinal measure of overall pain intensity during and after surgery measured at          the time of suture removal.        -  11-point ordinal measure of satisfaction with treatment        -  PROMIS upper extremity      Explanatory Variables:        -  Distal Sensory Latency (DSL)        -  Distal Motor Latency (DML)        -  EMG changes        -  Demographics: age, sex, race, occupation, avocation        -  Time limit between two surgeries < 6 months        -  Relevant comorbidities: Trapeziometacarpal (TMC) arthrosis, ulnar neuropathy, trigger          finger        -  Involved hand (Dominance, Side)        -  First side vs. second side surgery        -  PROMIS Pain Interference Computer Adaptive Testing (CAT)        -  Pain Self Efficacy Questionnaire (PSEQ-2)        -  PROMIS Depression      Methods The investigator and study staff will invite all adult patients (age 18 and older)     presenting to the Orthopaedic Hand and Upper Extremity Service Department at Massachusetts     General Hospital (MGH) with bilateral carpal tunnel syndrome planning staged bilateral carpal     tunnel release.      Analysis Power analysis An a priori power analysis for matched pairs was performed. To detect     the difference between two dependent means an effect size of 0.5 at alpha of 0.05 and 80%     power, a total sample size of 34 patients is needed.As the investigator expects to have     patients who will be lost to follow-up the investigators will count 10% extra, a total of 38     patients will be needed.      Univariate analysis: Variables will be presented with frequencies and percentages for     categorical variables and as mean with standard deviation or median with interquartile range     for respectively normal or non-normal distributed continuous variables. Normality of     continuous distributed variables will be tested a paired T-Test.      Bivariate and multivariable analysis will be performed and subsequently all variables with a     probability < 0.10 in bivariate analysis will be inserted in a backward, stepwise,     multivariable linear regression analysis to assess their ability to explain variation in     outcome. The 11 point Likert Pain scale score is considered significant when there is a     difference of more than 1.4 points (2.8 SD*0.5 effect size)on a scale from 1-10.[9]   "
83093|NCT02198378|"     In the management of acute coronary syndromes with ST-segment elevation (STEMI), early     analgesia reduces the effects of hyperadrenalism which increases the size of myocardial     infarction. In order to reduce pain intensity, the recommendations advocate emergency use of     morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at     least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely     used in emergency medicine and has minor secondary effects that are very rapidly reversible     when inhalation is discontinued. Used in association with paracetamol, it could be an at     least equally effective alternative to the use of morphine.   "
83094|NCT02198365|"     The investigators hypothesis is HPV integration could result in expression of oncogene     transcripts, and not only constitutive expression but also the level of expression will be     decisive for transformation and the maintenance of the malignant phenotype. Moreover, the     expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the     severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).   "
83095|NCT02198352|"     The objective of the present study is to obtain information about the safety, tolerability     and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing     doses in healthy male and female volunteers   "
83083|NCT02198508|"     Background: Three iron chelators now available on the market differ in toxicity and organ     specificity; evidence on standardized chelation protocol remains inconclusive, but patients     with transfusion-dependent beta-thalassemia treated with DFO infusion show significant     differences in the limitations of daily activities, physical activity, and quality of life     when treated with oral chelator. With licensing of DFP in America, it is reasonable to     combine DFP with DFX. Patients find two oral chelators more acceptable than one oral and one     injectable. This pilot study rates use of DFP for improving iron excretion profile of     deferasirox.      Methods: The investigators enrolled 13 beta-thalassemia patients in China Medical University     Children's Hospital in May 2009-October 2011. Five refused to take part in pharmacokinetics;     they only participated in iron excretion study. Seven with irregular bowel function were     unable to collect feces in the screening period as baseline data. Subjects were randomly     assigned and rotated to undergo all treatments (with informed consent): (A) single oral dose     of DFX 30 mg/kg once daily, (B) single oral dose of DFP 40 mg/kg twice a day, (C) oral doses     of DFX and DFP administered sequentially (DFX 30 mg/kg/d, deferiprone 40 mg/kg/d and     deferiprone 40 mg/kg/d at 7-hour intervals). Three-day drug dosage was followed by four-day     washout. Collections of urine and stool proceeded 24 hours per day, each analyzed separately.     Through a venous catheter, serial blood samples (1 mL/each sampling) were collected in glass     tubes containing heparin as anticoagulant at Time 0 (pre-dosing) and at 0.5, 1, 1.5, 2, 2.5,     3, 3.5, 4, 4.5, 6, 7, 8, 10, 12 and 24 hours after dose; plasma concentrations of DFP and DFX     were measured.   "
83084|NCT02198495|"     Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron     supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with     or without additional use of erythropoiesis-stimulating agents (ESA).      The investigators aim to compare two different intravenous iron preparations, ferric     carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary     objective is to assess whether both agents are equally effective to maintain a target     haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin,     transferrin saturation, and how much ESA therapy is administered.      Patients will be randomly assigned to either treatment group and followed in parallel over an     active study period of 40 weeks.   "
83086|NCT02198469|"     Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few     cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy     prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative     fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may     improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and     without Er:YAG AFL in treating AC   "
83087|NCT02198456|"     The aim of the study is to intensify the follow up of patients with pulmonary arterial     hypertension via modern imaging guided methods in due consideration of the possibilities of     three-dimensional echocardiography in order to optimize their specific therapy.      The hypothesis is that the increased use of modern imaging guided tools is essential for the     follow up.   "
83088|NCT02198443|"     The main objective of this study is to compare the tolerability and adherence to a new drug     regimen of post-exposure prophylaxis (PEP) for HIV,   "
83089|NCT02198430|"     Multidisciplinary assessment of the physical, functional and psychosocial alterations in     patients with hemophilia around the country. The aims of this study are:        -  Descriptive study of joint involvement in hemophilia patients with and without a history          of hemarthrosis.        -  Descriptive study of the alterations of periarticular muscle strength as a result of          acute processes or the development of chronic articular sequelae.        -  Descriptive study of biomechanical changes in lower limb joints and their impact on gait          in patients with hemophilia.        -  Descriptive study of the joint space, regarding hemarthrosis and synovitis,          intraarticular by ultrasonography.        -  Descriptive study of the relationship between skeletal muscle pathology in patients with          hemophilia and their perceptions of it and their quality of life.   "
83090|NCT02198417|"     PCOS occurs when a woman does not release an egg regularly each month, causing her periods to     be irregular. Women with PCOS can also have increased hair growth on the face and body, acne,     head balding, infertility, pre-diabetes, and diabetes. PCOS is commonly treated with oral     contraceptive pills (also known as the birth control pills). Sometimes, a medication called     metformin is also used to treat PCOS, especially if a woman has evidence of insulin     resistance or if fertility is desired. Unfortunately, metformin works in only some women with     PCOS. The mechanism through which metformin works in PCOS is not clear and it difficult to     predict who will benefit from metformin treatment and who will not.      The investigators are doing this research study to look at how the medication metformin     affects the cells in the body of patients with PCOS. Specifically, the investigators will     look at how metformin affects the mitochondria. Mitochondria are the part of cells that     produce fuel (energy) for other cells and play a role in metabolism. The investigators would     like to see whether there is a relationship between mitochondrial activity and symptoms of     polycystic ovary syndrome (PCOS) before and after treatment with metformin. They would also     like to study whether genes affect the response to metformin in women with PCOS.   "
83091|NCT02198404|"     In the palliative care unit, certain patients suffer from pain associated with medical     procedures/care which is poorly controlled by antalgics. These situations may necessitate     temporary sedation to improve comfort and facilitate treatment. No proven consensus exists,     either in the literature or in clinical studies conducted, on the choice of sedative agent     however Midazolam is the general recommendation.      The investigators believe that Propofol could be used in this instance   "
83092|NCT02198391|"     This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two     dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.   "
83096|NCT02198339|"     Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS in patients with a single     acute migraine attack with or without aura   "
83097|NCT02198326|"     The objective of the present study is to obtain information about the safety, tolerability     and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing     doses in healthy male and female volunteers   "
83099|NCT02198300|"     Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary     interventions (PCI) and are associated with higher rates of periprocedural complications as     well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting     (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary     bifurcations treatment is still a subject of debate, especially when the side branch is     large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives     are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials     with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting)     study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now     performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.   "
83100|NCT02198287|"     Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.   "
83101|NCT02198274|"     Study to evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled     sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12     administrations) in patients with metastatic colorectal cancer.   "
83102|NCT02198261|"     Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical     minoxidil exhibits a good safety profile, the efficacy in the overall population remains     relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth,     minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the     significant time commitment and low response rate, a diagnostic test to identify     non-responders prior to initiating therapy would be advantageous.      Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the     sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have     demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked     hair follicles correlates with minoxidil response in the treatment of AGA and thus can server     as a predictive biomarker.      Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify     non-responders prior to initiating therapy with 5% topical minoxidil foam.      The primary purpose of this study is to evaluate the clinical validity of the minoxidil     response in-vitro diagnostic kit.   "
83123|NCT02197975|"     Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese     Descent Following a Single Dose and After Chronic Dosing for 7 Days.   "
83103|NCT02198248|"     Previous reports suggested conventional immunosuppressants such as cyclophosphamide could not     reduce glucocorticoid dose in remission induction in ANCA-associated vasculitis because of     lower remission rate and higher relapse rate. However those reports didn't include rituximab.      B cell depletion therapy by rituximab is a new strategy for remission induction in     ANCA-associated vasculitis. The RAVE and RITUXVAS trial (NEJM 2010, both) showed high-dose     glucocorticoid plus rituximab had roughly the same efficacy and safety as high-dose     glucocorticoid plus IV-cyclophosphamide. In addition, recent retrospective observational     studies reported low-dose glucocorticoid plus rituximab led to re-induction in severe     relapsing ANCA-associated vasculitis.      Thus, the investigators aim to investigate whether rituximab can reduce glucocorticoid dose     in induction remission in ANCA-associated vasculitis (to show non-inferiority for efficacy     between low-dose and high-dose glucocorticoid plus rituximab). Participants will be     randomised to the low-dose glucocorticoid plus rituximab or the high-dose glucocorticoid     plus rituximab groups. Primary endpoint is proportion of remission at 6 months, then data     regarding relapse and long-term safety will be collected until 24 months.      The study has been designed by the principal and coordinating investigators. It will include     140 participants from 18 hospitals in Japan. It is funded by Chiba University Hospital and     Chiba East Hospital.   "
83104|NCT02198235|"     This study looks at addition of medications to the local anesthetic for the nerve blockade.   "
83105|NCT02198209|"     Type 2 diabetes is a chronic disease that has reached epidemic proportions. In order to     improve our strategies for preventing and treating type 2 diabetes the investigators need to     better understand the mechanism of this disease, and the way in which current therapies, such     as the drug liraglutide, work to control blood sugar. It is known that liraglutide acts via     increasing the secretion of the hormone insulin from the pancreas, hormone that in turn     controls blood sugar. However, it is not known whether liraglutide also has actions on the     liver. Animal studies have suggested that liraglutide might act by controlling the liver     enzyme glucokinase (GCK), an enzyme that increases blood sugar uptake by the liver. This     could be a crucial mechanism in which liraglutide controls blood sugar independently of     insulin, thus making it beneficial not only in type 2 but also in type 1 diabetes. The effect     of liraglutide on GCK activity has not been yet measured in humans. The investigators propose     to investigate the acute and chronic effect of liraglutide on GCK by using a simple, widely     used procedure (an IntraVenous Glucose Tolerance Test-IVGTT) and a novel approach     (mathematical modeling of data obtained from this procedure), to assess GCK activity in     people with type 2 diabetes. The investigators will first compare data obtained form 2 IVGTTs     (with and without liraglutide) performed 1 week apart (acute effect). The investigators will     then give liraglutide to patients for 6 weeks and do another IVGTT to measure GCK activity     (chronic effects). Data obtained from this study will be used to further understand the     mechanism of liraglutide action and how to better employ our current therapeutic options and     develop new strategies for preventing and treating diabetes.   "
83106|NCT02198196|"     The purpose of this study is to explore the efficacy of a phone-based weight loss program     that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The     program is targeted at employees of certain companies who meet a cut-off score on a measure     of stress-related eating. The control group will receive a standard phone-based program with     no additional stress management information (Weight Talk-Standard).        -  Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience          decreases in their stress-related & emotion-related eating compared to the Weight          Talk-Standard (WT-S; n=25) group.        -  Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.        -  Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased          eating self-efficacy, increased acceptance of weight-related thoughts & feelings and          increased mindfulness compared to those in the WT-S control arm.        -  Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss          program as those in WT-S.   "
85129|NCT02171754|"     The objective was to investigate the effect of ritonavir, an inhibitor of P-glycoprotein     (P-gp) and cytochrome P450 3A4 (CYP3A4), on the pharmacokinetics of BIBW 2992   "
83107|NCT02198183|"     The purpose of this study is to measure cerebral oxygenation and cardiac output of total     shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure     ventilation (PPV).      We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare     during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is     well maintained under GA in the sitting position when epinephrine is used, but that decreased     cardiac output increases the risk of cerebral desaturation.   "
83108|NCT02198170|"     The purpose of this study is to assess the influence of simultaneous CYP3A4 and     p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg     lenvatinib.   "
83109|NCT02198157|"     -  Labor is divided into three stages: the first stage is from labor onset until full          dilation, second stage is from full dilation until delivery of the baby, and the third          stage from the delivery of the baby until the delivery of the placenta        -  The mean duration of second stage in nulliparas as defined by the American college of          obstetricians and gynecologists (ACOG) is 54 minutes        -  Epidural anesthesia is a known cause for prolongation of the second stage of labor.          Prolonged second stage in nullipara women with epidural is defined as more than 3 hours,          and more than 2 hours in those without epidural.        -  Although perinatal outcome is not compromised with a prolonged second stage , there is          evidence that maternal morbidities such as perineal trauma, chorioamnionitis          ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage        -  Another effect of epidural anesthesia during labor is urinary retention and a need for          catheterization.        -  Full bladder may behave as a tumor previa and interfere to fetal head descent in the          birth canal, increasing by that the duration of the second stage.        -  This study aims to investigate the effect of intermittent versus continuous          catheterization on the duration of the second stage of labor   "
83124|NCT02197962|"     The objective of this study is to compare the results of 2000 impulses of radius shockwaves     per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of     patients with severe primary knee osteoarthritis, who did not satisfactory respond to     previous conventional treatments.   "
83110|NCT02198144|"     African American men have the highest risk of any group for early death & disability from     high blood pressure (BP). Clinical investigations in Dallas, TX demonstrated that African     American men with high BP are able to improve their BPs when participants agree to have their     BP measured at their barbershop by their barber & also take BP reducing medication as     instructed by a healthcare team that includes their doctor. The goal of this study is to     bring a barbershop-based model of BP measurement, treatment & follow-up from Dallas, TX to     the Southern California area. This study is the 2nd of two Barbershop studies at     Cedars-Sinai Medical Center. The 1st study was called the Barber-Based Intervention for     Hypertension in Black Men: Baseline Data Collection. In this 2nd study at Wally's     barbershop, the Investigators will enlist pharmacists to integrate the community health     promotion program in barbershops into the healthcare system. Barbers are uniquely positioned     to facilitate hypertension case detection & referral, pharmacists are uniquely positioned to     facilitate case management. Pharmacists have extensive knowledge of BP medication & they have     earned the respect of patients and physicians alike. In this intervention study, barbers will     be trained to measure the BP & refer those who have already been identified as having high BP     to a community pharmacist for confirmation of uncontrolled high BP & development of a BP     management plan. The pharmacist will work with the customers' physicians to optimize the BP     medication prescribed & with individual customers to provide a user-friendly medical home.     Pharmacists will improve the customer's access to state-of-the-art medical care, The data     from this study will be used to apply for a new NIH Grant. In addition, the summarized data     will be shared with key stakeholders in the local community (including barbers, patrons,     local healthcare providers, local pharmacists & other community leaders) to design a larger     community-partnered intervention.      Specific Aims:      Aim 1. To evaluate the impact of the new intervention model on HTN control in African     American males.      Aim 2. To evaluate the cost-effectiveness of the new intervention. The investigators     hypothesize that the projected cost-savings to the healthcare system in reduced heart attack     & stroke care will outweigh intervention & medication costs.   "
83111|NCT02198131|"     This pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia.     Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk,     such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens     after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation     dysphonia.   "
83112|NCT02198118|"     Background: Breast cancer is the most common type of cancer among women. Its treatment,     including radiotherapy (RT), can cause potential complications to be treated by the     physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper     limb applied during the period of radiotherapy in women submitted to surgical and     radiotherapy for breast cancer. Study design: This is a prospective randomized controlled     clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March     2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the     end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm     circumference. They were divided into two groups: CG) control group, submitted only to the     assessments and SG) study group, submitted to domiciliary physiotherapy.   "
83113|NCT02198105|"     Observational registry including patients with peripheral artery disease due to     femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent     drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).   "
83114|NCT02198092|"     This is an observational, case-control study evaluating the quantitative level of Septin9 in     plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients     (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple     Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family     members as controls and references.   "
83115|NCT02198079|"     To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric     patients with cystic fibrosis in the State fo Florida. HYPOTHESIS: There is high prevalence     of NTM in CF pediatric population in the State of Florida, and likely higher than in the rest     of the country.   "
83116|NCT02198066|"     The purpose of this study was to determine which of three types of dressings, a dry sterile     dressing, a metallic silver dressing or an ionic silver dressing provided better patient     outcomes for the post-sternotomy cardiac surgery patient population. In this prospective,     randomized controlled trial, the hypothesis was that subjects who received either of the     silver impregnated dressings would have better outcomes (better wound healing, less     discomfort, and less incidence of infection). Investigators also evaluated dressing factors     such as adherence, time for application and ease of use.   "
83117|NCT02198053|"     Different antiplatelet drugs played various role in coronary artery disease. The mechanisms     were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel,     Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and     dyspnea risk, both loading double dose and following second dose time had potential risk and     inconvenient in routine clinical work, especially in elective PCI of comparable stable     patients in Chinese. The benefit and risk should be balanced in such patients. The     investigators supposed loading single dose and followed by second routine time dose was     superior to clopidogrel and safer than ticagrelor previously prescribed.   "
83119|NCT02198027|"     Patients may feel significant pain at the surgery site after they wake up from the surgery.     Usually pain is managed in the ward by giving strong pain medication that may slow down your     mobilization and recovery process. Some recent work in other countries has shown that if     investigator give patients an injection at the end of the operation, patients have less need     for pain medication when they wake up. If investigator find that is also true in our     population, then we can use this method as routine step after this operation to improve pain     management and early mobilization of our patients   "
83120|NCT02198014|"     This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual     therapy using joint traction, passive muscle stretching, and isometric exercise, active     resisted and proprioception exercises; and other treatment with educational sessions and home     exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia     and arthropathy of the knee.   "
83121|NCT02198001|"     This prospective study will include patients taking or having taken bisphosphonates and     needing dental extractions.      The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth     extraction sites.      In the test group (PRF) and in the control group (no PRF), we use the same atraumatic     extraction protocol associated with the same antibiotic procedure.   "
83122|NCT02197988|"     The purpose of this study is to compare two standard methods of pain control management used     at Spectrum Health for patients undergoing major surgery. The two methods being compared are     the thoracic epidural and the TAP block. The thoracic epidural method involves medication     being given through a patient's back and the TAP block involves medication being given     through a patient's abdomen (belly). The investigators will compare side effects experienced     by the patients that take part in this study, including a change in blood pressure, as well     as the patients' opinions about their pain management experience after surgery.   "
83125|NCT02197949|"     At present, patients diagnosed of a breast cancer with infiltration of the axillary     lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN)     technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the     surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The     reason for not performing SN is that patients diagnosed of an infiltrated axilla though     ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed     after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant     systemic treatment and the axillary clinical exploration is negative after the treatment,     different studies showed that the SN false negative rate is unacceptably high.      Despite these facts, a high proportion of patients with a positive axilla at diagnosis and     submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated     in the pathological study, frequently four or less neoplastic nodes. New methods of detecting     these patients with limited infiltrated nodes should be developed and new approaches to     axillary surgery (i.e., partial resection) should be offered.      To date, the only information expected to get after an axillary imaging is performed is if     the axilla is infiltrated or not. No information about the tumoral load is demanded. In the     other hand, level I and II ALND is performed according to established anatomic limits,     without selecting the nodes to be excised neither identifying the ones infiltrated for a     directed excision.      The aim of the study is to evaluate the ability of a specified and reproducible imaging     protocol for distinguishing patients with a high axillary tumoral load from the ones with a     low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be     the ones commonly affected, identifying these nodes injecting diluted methylene blue in the     retroareolar parenchyma and studying their tumoral load could help selecting patients with     high from those with low axillary tumoral load.      Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue     protocol), could eventually help to distinguish which patients should be submitted to a     classical level I and II ALND and which ones can be spared from excising the lymph nodes not     stained by the methylene blue.   "
83126|NCT02197936|"     Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and     the role of correct peristalsis is most important for correct sperm transport towards the     fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time,     an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and     may also account for heavy menstrual bleedings and menstrual pain.      In this study, the uterine peristalsis of women with adenomyosis will be investigated. This     condition is associated to heavy menstrual bleeding, menstrual pain and infertility.   "
83127|NCT02197923|"     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of     the uterus. It affects about 15-20% of the female population.      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation     (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been     correlated with adenomyosis.      Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as     local hyperestrogenism and elevated levels of prolactin (PRL) have been identified, but     autoimmune and mechanical factors are also hypothesized.      Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic     measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin     releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation     have been tried, but studies are few in number, retrospective, and have small sample sizes.      Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of     adenomyosis remains still unclear, there are not many satisfying treatment options and     diagnostics include mostly magnetic resonance imaging (MRI) and histology.      The investigators designed a series of 3 studies with a broad approach in understanding     adenomyosis. This is part 2.      In this study the investigators take both tissue samples and blood samples that will be     investigated in order to understand the basic processes leading to adenomyosis.   "
83138|NCT02197780|"     RATIONALE:      A substantial proportion of children and teenagers with suspected inflammatory bowel disease     (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical     decision rule that included a calprotectin stool test to discern which patients require     further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of     missing IBD cases. Although the number of negative endoscopies was reduced after introduction     of this strategy, still 22% of the referred children and teenagers underwent an unnecessary     invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by     activated neutrophils and this stool marker may be more IBD-specific than calprotectin.      OBJECTIVE:      To determine whether the specificity of S100A12 is superior to the specificity of     calprotectin without sacrificing sensitivity      HYPOTHESIS:      Inclusion of the calgranulin C stool test will improve the specificity of the     screening-strategy.   "
83128|NCT02197910|"     In this study we will assess the effects of bioactive peptide rich wheat products on blood     pressure and estimated cardiovascular disease risk. This will be a pilot, explorative,     cross-over, randomized double-blind 2 groups x 2-arms controlled, clinical trial. The     intervention will be based on commercially-packaged pasta, which will appear and taste the     same; (i) low dose bioactive peptides vs. (ii) high dose bioactive peptides. Inclusion     Criteria will be: Male and female non-diabetic adult volunteers at increased estimated CV     risk (ESC/EAS SCORE) with SBP 130-139 mmHg and/or DBP 85-90 mmHg); Age included between 40     and 70 years old; Primary prevention for CVD but otherwise in good general health and have     had no major illness in the previous 6-months; Volunteer providing their signed and dated     informed consent form. Exclusion Criteria will be: Severe medical illness/chronic     disease/gastrointestinal pathology (e.g. coeliac disease); Secondary prevention for CVD;     Treatment with drugs potentially affecting BP (including antihypertensive drugs) or other     related CV risk factors; Consumption of nutraceuticals, botanical extracts or other vitamin     supplements; Volunteer diagnosed as being hypertensive A total of 60 participants will be     recruited and following adherence to a standardized diet for a 4-week period, will be     randomly assigned to complete one of 2 treatment sequences by consuming a prescribed quantity     of pasta products for a 4-week period followed by a 4-week washout before random assignment     to the 2nd treatment.      The Primary Outcome will be the modification of office blood pressure (assessed by systolic     and diastolic BP, pulse and mean pressure (mean of 3 standing & sitting measures) and 24-hour     blood pressure.      Additional outcomes include: Anthropometric parameters (Weight, WC, HC, WC/HC, ICO, BMI),     Glucose and Lipid profile (TC, LDL-C, HDL-C, TG, non-HDL cholesterol, risk ratios), Estimated     CVD risk changes (EAS/ESC SCORE Charts), Measures of vascular health (FMD, PWA, PWV, Aix),     Liver and renal functionality biomarkers, 24-h urine collection at baseline of treatment     phase 1 and endpoint of the final phase will be analysed to account for potential confounding     of urinary sodium excretion (intake) As required by the GCPs and GLPs, all the SOPs have     already been established and all the personnel to be involved in the study is continuously     trained in trials with similar outcomes   "
83129|NCT02197897|"     Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors   "
83130|NCT02197884|"     The purpose of this study is to assess the effects of strong cytochrome P450 (CYP) 3A4     inhibitors (Itraconazole and Clarithromycin), on pharmacokinetics (PK) (study of the way a     drug enters and leaves the blood and tissues over time) of single dose of JNJ-54861911 in     healthy male participants.   "
83131|NCT02197871|"     Insufficient energy intake and systematic inflammation lead to malnutrition in patients with     chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the     patients'nutritional status by increasing energy intake and providing anti-inflammatory     elements，which can relieve the patients' symptoms and delay the disease progression.   "
90558|NCT02100748|"     The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with     placebo in patients with acute postoperative pain after bunionectomy.   "
83132|NCT02197858|"     During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood     pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called extended     hemodynamic monitoring depending on the operation and patient. Frequently an invasive     arterial cannula is used to provide continuous information on the blood pressure. This     invasive method is very accurate and clinically established, but can be linked to adverse     effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection     etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a     non-invasive manner. It thus offers beat-to-beat information even about the extended     hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke     volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform     EV1000 (Edwards Lifescience).      Assuming that the two methods are equal we plan to measure extended hemodynamic parameters     before, during induction and during ongoing anesthesia both invasive and non-invasive. Data     will be recorded every 30sec.      Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters     is to our knowledge rare and further assessment in this field is needed to offer patients a     potentially equally reliable but less invasive monitoring. Furthermore the study should model     the effect of remifentanil, propofol or its combination on haemodynamics .   "
83133|NCT02197845|"     Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of     Virginia to demonstrate:        1. the feasibility of using patient navigators to improve the percentage of children and          adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care        2. the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation and          adherence among adult patients with SCD eligible for HU      (Patient navigators may also be known as public health workers.)   "
83134|NCT02197832|"     This is a randomised controlled trial on the effect of endometrial injury in the cycle     preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that     endometrial injury will increase the ongoing pregnancy rate in FET cycles.   "
83135|NCT02197819|"     Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2%     in the general population. In young patients, recurrence after a primary dislocation is also     common (~60%) and multiple recurrent episodes can cause significant disability over time.     Following initial reduction of the joint, the traditional treatment for primary shoulder     dislocations has been immobilization in a sling, with the arm in a position of adduction and     internal rotation. The length of the immobilization period is controversial, however most     authors would recommend between three to six weeks in a sling followed by several months of     rehabilitation to include range of motion and strengthening exercises. The clinical course of     patients after this approach has been extensively investigated. Of particular interest is the     relatively high rate of recurrent instability in young patients, reported to be between 17     and 96%.      A prospective randomized trial is needed to determine whether in young patients (16-30 yrs of     age) following reduction of a first-time traumatic anterior shoulder dislocation, does     EMERGENT (<4 hours post reduction) immobilization of the affected shoulder in external     rotation reduce the rate of recurrent instability experienced within 12 months versus     emergent immobilization in a traditional internal rotation sling? Eligible patients will be     randomly allocated to the sling or ER brace. The results of this study will provide the best     evidence for choosing emergent immobilization for shoulder dislocations.   "
83136|NCT02197806|"     A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and     concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus     for near vision).   "
83137|NCT02197793|"     The purpose of this study is to evaluate the impact of a community mobilization intervention     on the uptake of HIV testing, linkage to and retention in HIV care using a community, cluster     randomized trial.   "
83139|NCT02197767|"     Will use of Rituximab reduce proteinuria over a 12 month period and will there be     preservation of kidney function with the use of this study drug?   "
83140|NCT02197754|"     There are two primary objectives to be addressed in this study: to assess the differential     response in bioavailability and metabolic pathways between lean and obese individuals exposed     to acute, short term (14 day), and long-term (10-week) consumption of polyphenol-rich fruits     (berries and apple), and beverages (tea); and to determine the differential systemic and gut     anti-inflammatory response between obese and lean individuals exposed to polyphenol-rich     fruits (berries and apple), and beverages (tea).   "
83141|NCT02197741|"     An additional, intermittent bolus application in patients with intrathecal opiate     administration for chronic pain syndrome may have a positive effect on the effectiveness of     the treatment. Thus, the effect of an additional, intermittent bolus application in patients     with intrathecal opiate administration was therefore investigated.      Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each     patient was submitted to two treatment periods in randomly chosen order (cross-over design):     1. standard treatment (continuous opiate administration) and 2. continuous opiate     administration with intermittent opiate bolus application. Both treatment periods lasted 14     days. Patients were asked to record pain intensity, side effects and satisfaction with the     treatment.      The following hypotheses were tested:        -  The application of additional opiate boli results in significantly lower pain intensity.        -  The application of additional opiate boli does not result in a higher rate of adverse          Events.   "
83142|NCT02197728|"     We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy     reduces operative time (from skin incision to detachment of the uterus) and lateral termal     damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine     manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all     aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy,     thereby hastening electrosurgical transection, reducing activation time and reduce lateral     thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished,     due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which     also affects speed of transection, electrosurgical device activation time and lateral thermal     damage.   "
84142|NCT02184650|"     The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks,     the association between:        -  the quantity of mother's milk and duration and breastfeeding        -  the intake of polyunsaturated fatty acids and iron during hospitalizations   "
83143|NCT02197715|"     This study will develop and initially evaluate Sex and Female Empowerment (SAFE), an     intervention designed to increase acceptance of and adherence to contraceptive practices     among opioid-agonist-maintained women of childbearing age. The intervention will be delivered     in one of two formats: a face-to-face brief intervention approach or a novel     computer-adaptive platform. To the extent that either version of SAFE is found to be     efficacious compared with usual care, it has the potential to reduce the number of unintended     pregnancies and consequently decrease the need for and the costs of child protective     services.   "
83144|NCT02197702|"     In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks     triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5     months during their usual clinic visit. This study will test whether children receiving a     high dose of vitamin D have less frequent and less severe asthma exacerbations compared with     those receiving placebo.The study will also document the safety profile of this strategy.   "
83145|NCT02197689|"     Taiwan has attracted much attention for its National Health Insurance (NHI) and healthcare     system around the world with many countries in Europe and the United States using it as a     benchmark. However, increasing medication costs over the past two years account for more than     25% of total expenditure, surpassing every OECD member and mounting increasing pressure on     the NHI. Nevertheless, patient medication adherence is relatively low. Thus, the     investigators assessed the effectiveness of a personalized medication management system for     improving the medication adherence for patients, in order to save long term medication costs.   "
83146|NCT02197676|"     Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow     blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6     courses, or relapse after initial response.   "
83147|NCT02197663|"     The lifestyle of Taiwanese people has been changed over the past decade with the improvement     of economic growth, environmental sanitation and the quality of medical care. Now the     investigators pay more attention to the increasing risk of people's diseases of civilization     than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular     accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the     patient of cerebrovascular accident cause a lot of money and is a burden of our country.      Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with     cerebrovascular accident. The investigators use some scales to assess efficacy of     acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual     Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.      Besides, the investigators notice that there are few journals about acupuncture effect of     treating depression following cerebral vascular accident. The investigators may underestimate     the amount of people having post-stroke depression. So the investigators use Hamilton     Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident     patient.      By assessing bio-psycho-social level of CVA patient, the investigators hope this study will     offer them more Holistic Health Care.   "
83148|NCT02197650|"     Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for     patient unable to receive any other form of Asparaginase.   "
83149|NCT02197637|"     The purpose of this study is to determine whether oral vinorelbine is effective in the     treatment of children with progressive or recurrent unresectable low grade glioma.   "
83150|NCT02197624|"     The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron     status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian     women. The investigators hypothesize that the genetic variant could enhance iron status and     iron absorption in Asian women.   "
83151|NCT02197611|"     Research project for the development, construction and validation of a questionnaire of     adherence to treatment in adult patients with hemophilia. It aims to build a scale according     to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2)     knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences     and difficulties, and 5) benefits of treatment.   "
83152|NCT02197598|"     The purpose of this study is to explore the treatment effects of Selincro in alcohol     dependent patients with liver impairment.   "
83156|NCT02197546|"     Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients     experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and     distress in children receiving an injection of a local anaesthetic (LA). Children scheduled     for dental treatment using local anesthesia as a standard treatment, received bilateral     acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the     patients stimulated the needles by massage. Two different treatment regimes were compared: a     standardized LA injection given 5 minutes after acupuncture, and an LA injection without     acupuncture. The order of treatment was randomised, with the two treatments performed on     different days. Pain intensity during LA injection, assessed by the patient with the Verbal     Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and     dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction     with the received therapy were also recorded.   "
83157|NCT02197533|"     Background: Overactive bladder (OAB) is a common condition among postmenopausal women,     requiring a multifaceted treatment approach that requires patient retention of information     given to them in clinic. Recall of recommendations is a key component of compliance.     Supplemental educational tools such as handouts and audiovisual information have been     investigated for their ability to improve patients' recall of information and increase     satisfaction with the clinical encounter.      Objective: To determine if a written list of seven management strategies for overactive     bladder leads to improved immediate and delayed recall of these recommendations in     postmenopausal women presenting with OAB compared to a traditional verbal discussion.      Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed     (2-week) recall of seven OAB management strategies will be compared between two groups. The     intervention group will receive a handwritten list during their verbal discussion of OAB     treatment while the control group will receive standard care (verbal discussion only).     Immediate and delayed recall will be assessed by a member of the study team who has been     blinded to participants' group assignments.      Results: The results of this study may guide clinicians in the most effective mode of     providing treatment recommendations to post-menopausal patients with OAB.   "
83158|NCT02197520|"     This study will look into insulin sensitivity (how the body responds to insulin) and effects     of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has     two treatment periods, each of which will last about four weeks. One drug (insulin peglispro     or insulin glargine) will be administered in each period. Participants will receive both     drugs during the study. Participants may remain on stable dose metformin, as prescribed by     their personal physician.   "
83159|NCT02197507|"     Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults.     Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also     validated questionnaires for self-assessment of the disease by the patient. Grip strength     measured using a digitized sensor used by the patient could be an additional tool to the     remote monitoring of patients with RA.      Main Objective : To evaluate the correlation between the measurement of grip strength in the     dominant hand measured by a digital sensor and activity of RA assessed by DAS 28      Secondary objective : Evaluate the correlation between grip strength of the dominant hand and     :        -  scores of fatigue and pain (VAS and FACIT)        -  the self-assessment scores known in RA : functional index Health Assessment          Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.      It is a cross-sectional study involving 150 patients followed in our department for RA. Grip     strength of the dominant hand will be measured by a digitalized sensor during a single visit     integrating into the routine monitoring of patients.   "
83160|NCT02197494|"     The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,     single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg     under fed conditions.   "
83161|NCT02197481|"     The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps     hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic     resection.   "
83162|NCT02197468|"     Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants     in the neonatal intensive care unit (NICU). It has been postulated that abnormal colonization     of the preterm gut, or an unfavorable balance between gut bacteria may contribute to the     development of NEC.      Recent clinical randomized studies and meta-analysis have shown that proactive colonization     of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all     Norwegian NICUs started routinely administration of probiotics to all extremely premature     neonates susceptible to NEC (gestational age <28 weeks/birth weight <1000g).      The current project is investigating the gut microbiome in patients receiving probiotics and     compare the the gut microbiome with moderate premature infants not receiving probiotics. In     addition, we are including a control of healthy full-term infants.      Samples containing feces from participants will be analyzed by state of the art whole-genome     sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.      Study hypotheses:        -  Probiotics given to extremely preterm infants will change the biodiversity of the gut          microflora.        -  Antibiotics given to these patients may influence the gut microflora also in infants          receiving probiotics. In particular use of vancomycin may change the gut flora.        -  After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics          will gradually resemble the gut flora of infants not receiving probiotics.        -  A cross-contamination of probiotic bacteria between patients treated with probiotics and          patients not treated with antibiotics may occur.   "
83163|NCT02197455|"     The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus     kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia     areata and its variants.   "
83164|NCT02197442|"     The study was an open label, balanced, randomized, two-treatment, four-period, two sequence,     single oral dose, crossover, fully replicate bioequivalence study of two formulations of     Valsartan 320 mg under fasting conditions.   "
83165|NCT02197429|"     A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture     protocol for the treatment of vulvodynia.      Hypotheses:        1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.        2. Acupuncture increases sexual function in women with vulvodynia.   "
83168|NCT02197390|"     Our Choice is one of three CORD (Childhood Obesity Research Demonstration) studies funded by     the Centers for Disease Control and Prevention in 2011 to test multi-sector, multi-level     approaches to prevent and control childhood obesity. Our Choice is translating evidence-based     approaches for modifying behaviors, policies, systems, and environments to promote fruit and     vegetable consumption, physical activity, water consumption, and quality sleep. The ultimate     goal is to assist Children's Health Insurance Program-eligible children between 2-12 years     old attain a healthy weight. In addition to site-specific intervention and evaluation     activities, Our Choice is working with the University of Houston Evaluation Center to conduct     a cross-site evaluation on a set of shared measures.   "
83169|NCT02197377|"     With an aging population a prevalence of edentulous patients increased above 60 % among     individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often     difficult because of the inadequate fitting of the standard mask to the face. In addition,     because of a reduction in muscle tone under general anesthesia, the air space in the     oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis     tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to     the standard face mask if the facial contours of the patient are not suited to the standard     face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than     in patients with intact dentition. The laryngeal mask airway (LMA) provides a better     alternative to the standard face mask if the facial contours of the patient are not suited to     the standard face mask.      We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™     with the newly released LMA Supreme™ in edentulous elderly patients for the success in first     attempt insertion, ease and time of insertion, and oropharyngeal leak pressure.   "
83170|NCT02197364|"     The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the     clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among     patients with ILD, and comparing them to the clinical diagnostic criteria and other     respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of     ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment     and after treatment.   "
83171|NCT02197351|"     It is thought that the development of cancer of the stomach follows a series of stages in     which the lining becomes increasingly abnormal. Early detection of precursors of gastric     cancer likely enable less invasive treatment.      The assessment of gastric mucosa using the endoscope is used to detect cancers and these     precursor lesions. Narrow band imaging uses filtered light already built into modern     endoscopoes to identify the early changes in the gastric lining.      The investigators' hypothesis is that narrow band imaging improves detection of precursor     lesions and is a method amenable to international standardization.      The investigators will conduct a prospective trial in which standard random biopsy, white     light guided biopsy, and narrow band imaging guided biopsy will be performed for each     patient. The yield of the different methods for gastric cancer precursors will thus be     compared.   "
83172|NCT02197338|"     1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove          bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer.        2. Given the small size of the bile duct orifice and its close proximity to the pancreatic          duct, selective biliary cannulation is the most difficult part of the endoscopic          retrograde cholangiography (ERCP).        3. New small diameter sphincteromes and short wire systems (which allow physicians to          control guidewires) offer potential, though untested advantages.        4. At most hosptial both the long and short wire systems as well as small versus standard          are routinely used for clinical care.        5. Our hypothesis is that small diameter, physician controlled wires favor biliary          cannulation        6. Our objective will be to assess whether small diameter sphincterotomes and short wire          physician controlled guidewire cannulation favors successful bile duct cannulation and          minimize complications.   "
83173|NCT02197325|"     The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary     Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and     stenting, can improve final infarct size and myocardial function.      ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to     standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI     patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or     the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given     after successful primary percutaneous coronary intervention of a left anterior descending     coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and     continued during stenting. The functional efficacy measures, related to the PICSO duration     and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed     offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI,     cardiac function, infarct size and level of microvascular obstruction will be assessed by     cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure   "
83174|NCT02197312|"     Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide     partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a     veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate     after 5 years   "
83175|NCT02197299|"     A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by     the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance).     Insulin resistance can be caused by the accumulation of fat within muscle of overweight     individuals. The aim of the present research is to test whether a novel nutritional     intervention containing L-carnitine can increase the amount of carnitine within muscle of     individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning fat'     within our muscles and it is hoped that increasing the amount of carnitine within muscle can     increase fat burning, lower muscle fat, reverse insulin resistance and ultimately lower blood     glucose levels and wellbeing. We also aim to investigate the cellular mechanisms underlying     any observed effects in a hope to identify further targets to lower muscle fat.   "
83176|NCT02197286|"     A ten week, blinded trial of vitamin D vs. placebo in 80 patients with schizophrenia or     schizoaffective disorder who have low blood levels of vitamin D and elevated blood levels of     the amino acid proline. The aims of the study are to evaluate an anticipated clinical     response to vitamin D supplementation including negative symptoms and cognitive deficits,     evaluate safety of vitamin D supplementation for schizophrenia patients and evaluate the     relationship of changes in plasma proline levels and efficacy outcomes.   "
83177|NCT02197273|"     The purpose of this study is to determine whether liposomal bupivacaine is effective in the     management of pain following total joint arthroplasty, as compared to standard of care     analgesia.   "
83178|NCT02197260|"     It is common practice to carry out the therapy of periodontal diseases in two phases. In a     first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are     removed using a cleaning method called scaling and root planing (SRP). After three to six     months the case is evaluated and, if necessary, further treatment is provided, usually taking     a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics     on clinical outcomes have been shown repeatedly but specific indications for antibiotics in     subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to     be issues of a long lasting controversy.This study assessed the differential outcomes of     periodontal therapy supplemented with amoxicillin-metronidazole during either the     non-surgical or the surgical treatment phase.   "
83179|NCT02197247|"     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase     inhibitor (TKI) agent.      Part A will assess the effect of rifampicin on the pharmacokinetic (PK) parameters of AZD9291     and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin and     AZD9291 in a fasted state.      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will     provide for additional safety data collection. All patients who complete Part A will be able     to enter part B, and continue to receive AZD9291 80 mg once daily until: disease progression;     they are no longer deriving clinical benefit; or any other reason.   "
83230|NCT02196584|"     Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid     speculum during intravitreal injections      Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with     those of the conventional lid speculum and caliper approach   "
83180|NCT02197234|"     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase     inhibitor (TKI) agent.      Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of     simvastatin and simvastatin acid, following multiple oral dosing of AZD9291 in a fasted     state.      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will     provide for additional safety data collection. All patients from Part A who completed     treatment may continue to receive AZD9291 80 mg once daily until: disease progression; they     are no longer deriving clinical benefit; or any other reason.   "
83181|NCT02197221|"     Phase III multicenter randomized, open-label study comparing the efficacy of a combined high     dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell     transplant in frontline multiple myeloma patients, non-progressive after induction therapy.   "
83182|NCT02197208|"     This is a randomized controlled trial on the comparison of the ongoing pregnancy rate in     frozen-thawed embryo transfer cycles with spontaneous ovulation and hCG-induced natural     cycles.   "
83183|NCT02197195|"     The purpose of the study is to understand the role chocolate milk compared to a fruit drink,     with and without exercise, on glycaemic regulation and subjective appetite in children. The     investigators hypothesize that chocolate milk in combination with exercise will have the     greatest effect attenuating glycaemic response. Blood glucose will be measured by finger     prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65     minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.   "
83184|NCT02197182|"     LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL     Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered     intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..   "
83185|NCT02197169|"     Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant     primary brain tumor in adults and can be resistant to conventional therapies. The purpose of     this Phase Ib study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor     responds to one injection of DNX-2401, a genetically modified, conditionally replicative and     oncolytic human-derived adenovirus. DNX-2401 is delivered directly into the tumor where it     may establish an active infection by replicating in and killing tumor cells.   "
83186|NCT02197156|"     The purpose of the study is to establish a dose-response relationship among several capsule     strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to     placebo following bunionectomy surgery   "
83187|NCT02197143|"     -  Currently, Proton Pump Inhibitors and H2Receptor Blockers are widely used by emergency          physicians in Turkey for the treatment of patients with dyspepsia.        -  The objective of the study was to assess whether intravenous esomeprazol has superior          dyspeptic pain reduction compared with ranitidine or hydrotalcid in emergency department          (ED) adults        -  The investigators second aim was to compare recurrent dyspeptic pain within 24 hours          after discharge and cost of treatments in the treatment of dyspepsia.   "
83188|NCT02197130|"     This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5     mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects     with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized     in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS)     assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of     treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea     (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global     Impression-Improvement score after 13 and 26 weeks of treatment.   "
83476|NCT02193347|"     Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive     testing from the primary tumor (initial diagnosis) will be offered this treatment study in     order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy     (temozolomide).   "
83189|NCT02197117|"     New treatments are required to improve health outcomes in patients with ischemic heart     disease. This is especially so in developing countries such as Mauritius in which optimal     therapy for acute myocardial infarction may not be widely available. For example for patients     presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the     treatment of choice would be to remove the blockage by primary percutaneous coronary     intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to     keep the artery opened. However, PCI is not widely available in Mauritius and heart attack     patients are given clot-busting therapy to remove the blockage, but this is not as effective     as PCI.      Therefore, in this research study we investigate a new cheap treatment that may help protect     the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in     which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated     for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart     attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff     a protective signal can be relayed to the heart to reduce the amount of damage occurring     during the heart attack and thereby prevent the onset of heart failure.      Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to     the heart muscle during a heart attack..   "
83190|NCT02197104|"     The objective of this study is to determine if citocoline is effective for balance     abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor     ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months in an     open label pilot study, with study visits at baseline, 3, 6, and 12 months.   "
83191|NCT02197091|"     This pilot research trial studies communication effectiveness in cancer treatment. Studying     how well patients and their doctors communicate about the treatment being given for cancer     may help improve the decisions that patients and physicians make together.   "
83192|NCT02197078|"     This protocol is for a series of comparative effectiveness and safety analyses within     periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and     other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety     of health outcomes. The primary analysis will be conducted among patients without prior     within-class medication use.   "
83193|NCT02197065|"     Up to 35% of hip fracture patients have been shown to experience heart injury after surgery,     and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee     arthroplasty patients are also at risk of cardiovascular complications. Patients who have     these complications have higher levels of inflammation postoperatively. Statins (such as     atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects     are important in preventing heart attacks. Statins have been shown to reduce the risk of     heart attacks in non-surgical patients, and to protect from heart attacks in patients having     heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known.      In this pilot study the investigators will treat 30 orthopedic surgery patients (hip     fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no     study drug). Patients will start the study drug prior to surgery and take it for 45 days     after surgery. Neither the doctors nor the patients will know whether they are taking     atorvastatin or placebo. The investigators will look for evidence of inflammation and heart     injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree     of postoperative inflammation found in these patients. In this study, the investigators will     use a very sensitive test of heart injury that can detect problems even when patients have no     symptoms. The investigators hypothesize that this test will demonstrate silent heart injury     in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study.      The results of this trial will help us to develop a larger study in 1000 hip fracture and     joint replacement patients to determine whether atorvastatin protects orthopedic surgery     patients from heart injury and other complications of surgery.   "
83194|NCT02197052|"     The goal is to better understand the social needs of a population seeking care in a large,     urban children's hospital emergency department with a large Medicaid population. Consenting     English and Spanish-speaking adult caregivers will be randomized to social screening via a     face -to-face interview with a trained bilingual researcher or via a self-completed     tablet-based survey. We hypothesize that there will be no difference in disclosure rates     between the two screening formats for items other than highly sensitive items. For highly     sensitive items we hypothesize disclosure rates will be higher for the self-completed     tablet-based survey.   "
83195|NCT02197039|"     The purpose of this prospective study is to identify risk factors which could predict poor     fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful     endoscopic hemostasis and high-dose PPI infusion. These risk factors will be the selection     criteria for patients who are indicated to receive second-look endoscopy.   "
83196|NCT02197026|"     Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc®     versus usual treatments as well as evaluation of safety and effectiveness of these     treatments.   "
83197|NCT02197013|"     Incidence and time of occurrence of blood leakage with the closed intravascular catheter     Introcan Safety 3 in comparison to Introcan Safety   "
83198|NCT02197000|"     The purpose of this study is to determine whether adding DIM supplement will decrease breast     density among female BRCA mutation carriers in two years.   "
83199|NCT02196987|"     Currently, there are no specific guidelines or best practice suggestions for best male     catheterization as fat as insertion technique. There is however, information as to reducing     infection, and as to recommended lubricant.      From our experience, the investigators have noticed that when requesting the patient to     attempt urination while inserting a urethral catheter, the level of pain and discomfort is     reduced. In this study, the investigators will evaluate the pain level during male urethral     catheterization in each technique.      Our hypothesis is that the level of pain will be much less if the in the study group where     the act of urination will be requested from the patient.   "
83200|NCT02196974|"     In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies     obtained with flexible cryoprobes compared to standard techniques? For patients with     peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue     to be obtained and therefore, will increase the diagnostic yield over conventional techniques   "
83254|NCT02196272|"     A number of strategies have been evaluated to improve clinical outcomes in diabetics     patients, however no studies explored the efficacy of a nurse-led reminder program through     email (NRP-e) to improve medication adherence, even if it is fundamental in the management of     diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led     reminder program through email (NRP-e) to improve medication adherence in diabetic patients.   "
83477|NCT02193334|"     This study is randomized, double-blind, placebo-controlled Phase I/II study designed to     evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation     for intrathecal injection, as a treatment for acute spinal cord injury. The study is     conducted at two clinical sites in Japan.   "
83201|NCT02196961|"     Primary Objective:      To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected Merkel cell     carcinoma (MCC) patients; i.e. the primary endpoint is disease-free survival (DFS) in arm A     at 12 months, defined as the number of patients alive and free of disease at 12 months after     randomization compared to DFS in arm B.      Secondary Objectives:      To assess safety and additional efficacy parameters of the ipilimumab or nivolumab treatment     in MCC, as well as to characterize potential biomarkers; secondary endpoints are: (i) adverse     events according to CTCAE (Common Terminology Criteria for Adverse Events), Version 4.0     criteria, that are definitely, probably, or possibly related to the administration of     ipilimumab, (ii) Overall survival rate at 12 months, defined as the number of patients     surviving at 12 months after randomization divided by the total number of patients     randomized, (iii) DFS rate at 12 months, defined as the number of patients alive and free of     disease at 12 months after randomization divided by the total number of patients randomized.   "
83202|NCT02196948|"     Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that     eccentric exercise protocols can be effective for this condition. The inclusion of other     therapeutic modalities could help to the management of these patients. A new therapeutic     approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed.     The objective of this randomized clinical trial is to determine the effectiveness of the     inclusion of EPTE into a eccentric exercise protocol for the management of patients with     unilateral supraspinatus tendinopathy   "
83203|NCT02196935|"     Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly     being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology     patients at the Los Angeles County Hospital presents a unique and diverse patient population.      Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct     stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI     cancer diagnosis and management, and the management of pancreaticobiliary problems in the     underserved.      All patients managed by EUS or ERCP at the LA County & USC University Hospitals will be     enrolled in the databaseThe timing, clinical presentation, and objective details of patient     presentation are recorded prospectively. Additionally the results of the subsequent ERCP and     EUS procedures. Subsequent, clinical course and pathology will also be recorded.   "
83204|NCT02196922|"     In the US, racial and ethnic disparities persist, even when income, health insurance and care     access are addressed. For example, there is a greater prevalence of chronic heart failure     (CHF), higher rates of hospital use and higher death rates in blacks as compared to whites.     This is due to many factors including: reduced healthcare access, higher prevalence of     hypertension,coronary artery disease, systolic dysfunction, myocardial infarction and     obesity. Given the magnitude of this chronic health issue, the growth of the elderly     population, and increases in ethnic diversity, providers need to develop new ways of caring     for those with chronic conditions living in health disparity communities.      The investigators propose to implement a randomized study with health disparity     community-dwelling patients. A bilingual clinician will follow patients for 3 months after     hospitalization for CHF to test this approach for the proposed health disparity population.     The investigators will obtain patient/caregiver input at multiple points during the research     to make necessary adjustments to the intervention to ensure that disparity patients     accept/use the system, and are satisfied. To ensure that proposed outcomes have relevance for     patients, a Community Advisory Board (CAB) of stakeholders will advise the study team     throughout the study process. The investigators believe that studying patient use of TSM over     a 3 month period will: 1) identify cost-effective care approaches for patients living with     chronic disease; 2) involve the patient in identifying and testing approaches that work for     them; 3) enhance provider-patient communication; 4) teach the patient how to self-monitor and     explore his/her role in self-care; 5) improve patient education about treatment options and     6) explore how usable the patients feel the program is. If our goals are achieved, these     strategies will result in patient-led improvements in health, satisfaction and quality of     life. Knowledge gained will further understanding of the use of telehealth programs as     effective self-management tools.   "
83205|NCT02196909|"     The objective of the study is to identify the best clinical and biological outcome measures     for further therapeutics approaches.   "
83206|NCT02196896|"     The purpose of this study is to determine the acceptance and efficacy of the online self-help     program deprexis® for depressed patients in reducing the clinical symptoms of their     depression. The patients of the experimental group use deprexis® for 90 days, the patients of     the placebo group receive weekly online information about depression for 90 days as well.     Both groups receive their treatment in addition to their regular inpatient psychosomatic     treatment and as an aftercare intervention.The investigators hypothesize that the online     self-help group achieves a greater reduction of depression compared to the control group.   "
83207|NCT02196883|"     Patients are being asked to participate in a research study because the patients are being     treated for low back pain and the patients have decided to have an epidural steroid     injection.      Low back pain has a tremendous impact on the individual and society. It not only affects the     individuals quality of life, it also contributes to lost productivity and increased health     care costs.      Epidural steroid injections (ESIs) are a common treatment option for many forms of low back     pain. They have been used for low back problems since 1952 and are still being used as a     non-surgical form of treatment for low back pain. The goal of the injections is reduction of     pain, increased quality of life and improved function.      This study is being conducted to determine the outcomes of injections given at the level of     MRI Pathology versus at the level of clinical symptoms to see if one is more effective     than the other and to learn more about the characteristics of the two different injections.   "
83208|NCT02196870|"     Patients with chest wall elastance increasing could worsen lung function. Increasing of chest     wall elastance plays a great role in lung mechanics, and could influence mechanical     ventilation settings. Therefore, It could help the physicians to find appropriate indicators     and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics     changse in the patients with high chest wall elastance.   "
83209|NCT02196857|"     The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help     to control the disease in patients with AML and high risk MDS with FLT3-ITD mutation. The     safety of this drug combination will also be studied.   "
83210|NCT02196844|"     The goal of this behavioral research study is to learn the opinion of patients and their     caregivers about a couple-based Hatha Yoga program (Group 1) during treatment for cancer.     Researchers also want to learn the effect of this program on lung function, distress,     biological function, and quality of life. For comparison purposes, there will also be a group     of participants (Group 2) that does not take part in this program.      You and your caregiver/family member will have about a 50/50 chance of being assigned to each     group. The groups are randomly assigned, but it is also based on other factors such as your     age and the status of the disease.   "
83211|NCT02196831|"     Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV)     infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of     patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of     NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and     fibrosis.      NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group     has previously shown that HIV-infected individuals with increased visceral adiposity     generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing     hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is     FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous     study, treatment with tesamorelin in HIV-infected individuals selected for abdominal     adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin     on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The     investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the     inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.   "
83212|NCT02196818|"     This is a multi-centre, prospective post marketing surveillance study to assess mid-term     performance of the Mpact cup in subjects requiring primary total hip arthroplasty.   "
83213|NCT02196805|"     This study compares the pharmacokinetics characteristics of a single oral intake of an     imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang     Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.   "
83214|NCT02196792|"     The objective of the study is to investigate head penetration, cup migration, and clinical     outcome in total hip replacements using a factorial design. Treatment groups are E-Poly     versus ArComXL liners, and 36 mm versus 32 mm head size.   "
83272|NCT02196038|"     REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a     multicenter, randomized, attention-controlled, single-blind trial designed to examine the     hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain     rehabilitation intervention administered to older patients with acute decompensated heart     failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will     improve physical function and key clinical outcomes, including the rate of rehospitalization.   "
83215|NCT02196779|"     Abdominoplasty is a common cosmetic operation. Some investigators believe that the risk of     complications is reduced by limiting the operative dissection. However, this can compromise     the quality of the result. This study was undertaken to investigate the blood supply of the     abdominoplasty skin flap during surgery using laser fluorescent imaging. An imaging agent is     injected and the fluorescence is recorded using a near-infrared laser. The blood supply is     tested after a limited dissection and then after a traditional dissection to determine     whether an extended dissection reduces the skin circulation. The study hypothesis is that     there is no difference in blood supply and the traditional abdominoplasty does not compromise     skin circulation.   "
83216|NCT02196766|"     To determine if patients are unreactive to the lens care solution / Biofinity combination.   "
83217|NCT02196753|"     The aim of this single-center randomized controlled trial is to assess clinical usefulness of     positron emission tomography combined with computed tomography (PET CT) in the diagnostic     process of suspected cardiovascular implantable electronic device (CIED) infection (lead     dependent infective endocarditis, generator pocket infection, fever of unknown origin).   "
83218|NCT02196740|"     The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root     canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in     the treatment of periapical periodontitis of deciduous teeth is superior to other drugs     currently in use as creosote.   "
83219|NCT02196727|"     The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation     receiving multimodal analgesia in day-case surgery setting.      Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom     Cleft Lift operation.   "
83220|NCT02196714|"     A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,     Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the     Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.   "
83221|NCT02196701|"     The purpose of this study is to determine the safety and efficacy of the use of the     combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in     suboptimal responders to ADA monotherapy.   "
83222|NCT02196688|"     Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and     one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor     activity in patients with advanced CRC in phIb study.      This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of     patients with metastatic CRC who have progressed after metastatic CRC second line or above     standard chemotherapy.   "
83223|NCT02196675|"     Collection of real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung     cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm     and/or 60 mm (study devices) in a Korean population.   "
83224|NCT02196662|"     The primary objective of this study is to compare the rate and extent of absorption of     mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus     Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral     dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x     400 mg delayed-release capsule under fasting conditions.   "
83225|NCT02196649|"     Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal     Resection (EMR) site following complete removal of the lesion, or will not receive clips and     proceed with standard of care.   "
83226|NCT02196636|"     This two-part study will assess the safety and tolerability of single ascending oral doses of     RO6806127 in a group of healthy male participants and investigate the effect of high fat and     high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a     separate group of healthy male participants. The relationship between drug exposure and     tolerability will be explored.   "
83265|NCT02196129|"     The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3     pharmaco-acupuncture in patients with low back pain admitted for inpatient care   "
83266|NCT02196116|"     This research aim to explore relationships between the presence of amyloid burden and     cognitive performance, and its modulation by educational level. For this purpose we will     combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired     on 3 groups of subjects, from two population-based cohorts 3C and AMIMage The first group     includes cognitively intact participants who will serve as controls, the second group,     subjects with mild cognitive impairments without memory complaint and the third, subjects     with both mild cognitive impairments and memory complaint.   "
83228|NCT02196610|"     People with kidney failure have a higher chance of getting disease in the blood vessels and     this result in a decreased elasticity of the arteries of their body which make them very     stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the risk     of stroke and heart disease. A novel way to know the stiffness of blood vessels is by a     method called applanation tonometry, which measures the pulse wave velocity of major     blood vessels such as the aorta, carotid and femoral arteries. The purpose of our study is to     determine if we can measure arterial stiffness reliably and accurately using this method in     healthy people and in people with kidney failure receiving hemodialysis treatments at our     centre. Also, we would like to know how stiff these arteries in healthy people are. If we     demonstrate that the method is reliable and accurate in these 2 groups of participants at our     centre, a future larger study is planned to determine if we can use measures of arterial     stiffness to evaluate the risk of stroke and heart disease in people with kidney failure     receiving hemodialysis. The research study will take place at the Ottawa Hospital-Riverside     Campus.   "
83229|NCT02196597|"     Background: High prevalence of fecal incontinence after rectal resection in patients with     rectal carcinoma.      Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict     fecal incontinence.      Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal     endosonography before and 1 month after closure. Prediction of postoperative incontinence by     the surgeon (digital sphincter examination). Visual analog scales for continence, subjective     success of operation, and global well being; Wexner and Vaizey incontinence score; Parks     incontinence classification; Rockwood fecal incontinence quality of life score; each before,     1 and 6 month after closure.   "
83231|NCT02196571|"     Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various     degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize     glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is     recommended to continue or initiate exercising with moderate intensity. However, available     data on the effects of physical activity on GDM are based on a small number of trials. The     aim of the trial is to examine and add new scientific evidence on possible health-related     effects of application of structured programme consisting of aerobic and resistance exercises     on the course and outcomes of GDM. Primary goal of research is to determine how proposed     exercise programme effects glycaemic control, rate of complications during pregnancy, labour,     delivery, immediate after delivery and health status of newborn. Main hypothesis is that     parameters of glycaemic control, course of GDM, complications during delivery and birth     outcomes directly and significantly correlate with participation in structured programme of     exercise. Research will be conducted as experimentally designed randomized controlled trial.     Participants will be pregnant women diagnosed with GDM, age between 20 and 40, without     comorbidities. Women in the experimental group will be included in exercise programme two     times per week with duration of 50 minutes. Training sessions will start right after the     diagnosis and will be performed until the end of the pregnancy. The training protocol will     follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008; NICE, 2008; ADA 2011).     Women in the control group will receive standard medical care.   "
83232|NCT02196558|"     This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study     is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate     mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011     in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg     group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400     mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011.     Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks     after the initial administration.   "
83233|NCT02196545|"     The purpose of this study is to determine if a home based physical activity training program     for patients with Alzheimer's dementia has effects on clinical and neurobiological     parameters.   "
83234|NCT02196532|"     Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can     provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer     (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in     several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's     disease. Different studies have reported RNFL changes also in migraine, is a common     hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic     nervous system. The pathophysiology of migraine has not been fully clarified, but there is     increasing evidence that episodes of migraine with aura are initiated by a focal reduction in     cerebral blood flow, which occurs most commonly in the posterior region of one hemisphere.     Although vasoconstriction of cerebral and retinal blood vessels is a transient phenomenon,     the chronic nature of the migraine might cause permanent structural abnormalities of the     brain and also of the retina, which may correlate with RNFL thinning. Previous studies on     this subject, however, reported contradicting results. Some investigations reported     reductions of the RNFL thickness while others did not. In the present study, in order to     determine whether RNFL thickness is reduced in migraine patients, the investigators performed     a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series     of migraine patients and in the healthy control groups.   "
83237|NCT02196493|"     We have noticed a group of patients presenting with a longstanding wet cough which has often     been treated as asthma. The cough is productive of sputum which frequently contains bacteria,     but does not resolve with standard antibiotic treatment.      A very similar cough is seen in subjects who smoke, have exposure to airbourne dusts or     chemicals or have a condition known as bronchiectasis, but these problems have already been     excluded.      We have found that prolonged treatment with an antibiotic called azithromycin is very     effective but using azithromycin in this way is not licensed and there is currently no trial     evidence to support its use.      This research will evaluate the clinical benefit of low dose azithromycin to determine if     this is an effective and safe treatment for these patients. It will also involve a detailed     investigation of these patients to determine whether they have enough in common to believe we     are describing a new condition.   "
83238|NCT02196480|"     Objectives: To assess immunogenicity and safety of the 23-valent polysaccharide pneumococcal     vaccine (PPV23) in JIA patients with and without anti-TNF therapy. The influences of     demographic data, disease activity and treatment on immune response and the potential     deleterious effect of vaccine on disease itself were also evaluated.      Methods: 17 JIA patients immediately pre-etanercept (Group 1) and 10 JIA patients on stable     dose of methotrexate (Group 2) will receive one dose of PPV23. All patients will be evaluated     pre-vaccination, 2 months and 12 months post-vaccination for seven pneumoccocal serotypes.     Serology will be performed by enzyme immunoassay and the immunogenicity endpoints will     include seroprotection (SP), seroconversion (SP) and geometric mean concentration of     antibodies (GMC). Clinical and laboratorial parameters of JIA will be evaluated before and     after vaccination.   "
83239|NCT02196467|"     This Phase I/II of the clinical trial is to investigate whether the transplantation of normal     myoblasts throughout one muscle (the extensor carpi radialis) of the patients is safe and     will improve the strength of that muscle. During this Phase I/II, the patients will be     transplanted with myoblasts grown from the muscle biopsy of a donor and kept frozen in liquid     nitrogen. Thirty million myoblasts will be injected per cm cube in a progressively higher     surface of the radialis (i.e., 3, 6 and 9 cm2). The contralateral muscle will be injected     with saline to serve as a control. The strength of both muscles will be measured at 3 months     post transplantation to verify whether the myoblast transplantation improved the strength of     the muscle. If there is no significant strength improvement, the protocol will be terminated     immediately for that patient. If there is a significant strength improvement, the patient     will be maintained under immunosuppression until 6 months post transplant and his strength     will be re-evaluated.   "
83240|NCT02196454|"     The purpose of this research study is to determine if video-based education will increase HPV     vaccination rates among 11 - 17 year olds.   "
83241|NCT02196441|"     General anaesthesia now a days is not the first choice in phakic intra ocular lens surgery     (Phakic IOL) , the short duration of the surgery, general anaesthesia complications, decrease     the length of hospital stay and decreasing the costs direct the interest to the regional     anaesthesia By the time the traditional retro and peribulbar injections recede to a newer     techniques that is safer and cheaper, sub tenon's block using a blunt needle took over due to     the more safety profile Even though, still serious problems can occur specially in patients     with long axial length.      Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took     over with promising and successful results, decreasing length of hospital stay and increasing     patient satisfaction and fewer margins of complications.      In this study the investigators compared topical anaesthesia alone with DTFNBA in patients     undergoing posterior chamber phakic IOL surgery (Visian ICL).   "
83242|NCT02196428|"     The aim of this study is to explore the requirements and conditions of medical     teleconsultation and remote diagnostics (telemonitoring) of older people in the residential     environment with an emphasis on the need for adaptation, feasibility and acceptance of     telemedicine services to a web based documentation and communication platform (Ambient     Assisted Living Wizard).   "
83243|NCT02196415|"     -  The measurement of hindfoot alignment is a technical challenge.        -  Today, hindfoot alignment is typically measured on hindfoot alignment view radiographs          or long axial view radiographs. Measurements on both types of radiographs are hampered          by technical shortcomings such as minimal rotational misplacement of the foot at the          time of image acquisition. In previous publications our study groups demonstrated          substantial measurement errors due to these shortcomings as well as bad interreader          agreement.        -  Hindfoot alignment measurement is feasible on MR images but hampered by the          non-weight-bearing position of the patient and therefore not suited for pre-treatment          evaluation.        -  In an ex vivo study using plastic phantoms of a foot our research group could          demonstrate superior interreader agreement and complete correction for foot misplacement          at the time of image acquisition using a 3D secondary measurement technique based on          biplanar low dose radiographs.        -  Image acquisition using biplanar low dose radiographs is associated with a substantial          reduction (about 1/7) of radiation dose applied to the patient compared to standard          radiographs.        -  Therefore the question arises if these excellent ex vivo results can be confirmed in a          prospective clinical study.      Objectives:        1. Evaluation of technical feasibility of 3D hindfoot alignment measurements based on          biplanar radiographs.        2. Reproduction of superior interreader agreement of measurements based on biplanar          radiographs compared to measurements on conventional radiographs.   "
83267|NCT02196103|"     Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity     of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has     led us to undertake the present clinical trial.   "
83293|NCT02195765|"     This is a split-mouth, double-blind randomized controlled trial. Computerized linear     radiographic measurements were used to detect infrabony defects treated with open flap     debridement (OFD) or OFD associated with enamel matrix derivative (EMD), after 24 months. Ten     patients presenting 2 or more defects were selected (43 defects). An individualized film     holder was used to take standardized radiographs at baseline and after 24 months. Images were     digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the     alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle.   "
83244|NCT02196402|"     Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow     band imaging (NBI), might allow the determination of polyp management and surveillance     interval, particularly in patients with diminutive polyps (< 5mm), in which the advanced     histological features are uncommon and the prevalence of invasive cancer is negligible (1).     On this basis, the American Society of Gastrointestinal Endoscopy (ASGE) has set an     initiative evaluating the applicability of real-time endoscopic polyp assessment in clinical     practice (1), which states that:        1. for diminutive polyps to be resected and discarded without pathologic assessment,          endoscopic technology (when used with high confidence) used to determine histology of          polyps < 5mm in size, when combined with the histopathologic assessment of polyps >5 mm          in size, should provide a > 90% agreement in assignment of post-polypectomy surveillance          intervals when compared to decisions based on pathology assessment of all identified          polyps.        2. In order for a technology to be used to guide the decision to leave suspected          rectosigmoid hyperplastic polyps <5 mm in size in place (without resection), the          technology should provide > 90% negative predictive value (when used with high          confidence) for adenomatous histology      This strategy could potentially exert a significant impact on colonoscopy practice, by     decreasing at some extent pathology-associated costs, although those related to histological     analysis of >5mm polyps is maintained.      In a recent study performed in our Centre (2), we restricted the application of the resect     and discard strategy to patients with small or diminutive polyps only, achieving an     accordance between endoscopy-directed and histology-directed surveillance strategy of about     85% in both populations. This approach, where decisions on patient management are driven only     by the in vivo endoscopic assessment, provides on one hand a slightly lower accordance than     the threshold of 90% set by the PIVI, but on the other one it allows the complete spare of     pathology related costs, although for a smaller proportion of patients. Moreover we observed     a negative predictive value of 86% for the presence of adenoma within the diminutive polyps     cohort, although a separate analysis for left sided ones was not performed.      AIms of this single center, prospective, observational study:        1. To prospectively evaluate the accordance between the endoscopy-directed and          histology-directed surveillance strategies by applying the resect and discard strategy          for diminutive polyps according to the PIVI statements        2. To assess the economic impact of the resect and discard strategy when applied either          according to the PIVI statements or to restrictedly to subjects with diminutive polyps          only        3. To provide a temporary validation of diagnostic performances of the resect and discard          strategy for our group and the potential presence of a learning effect for the          methodology        4. Accordance between endoscopists' and nurses' categorization of adenomas according to          standardized criteria (see below)   "
83245|NCT02196389|"     Several nasal dilators are currently commercially available, and can be applied endonasally     (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison     between these dilators has not been made so far, and would help the clinicians to advise the     use of any of these dilators. From clinical experience, endonasal dilators are well supported     and improve breathing better than the external dilators   "
83246|NCT02196376|"     In this pilot study, the investigators will test the hypothesis that patients with postural     tachycardia syndrome will have an elevated percentage of functional antibodies to adrenergic     receptors compared with control subjects without POTS. The investigators further hypothesize     that the percentage of POTS patients with antibodies will be higher in those patients with a     viral infection at the onset of their illness than in those patients with other or undefined     illness onsets.   "
83285|NCT02195869|"     The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in     subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.   "
83286|NCT02195856|"     Rationale:      Mediterranean style diets and diets rich in green leafy vegetables protect against the risk     of developing type 2 diabetes and a wide range of cardiovascular disease. These diets are     rich in nitrate. Numerous studies have shown that nitrate from the diet can have a wide range     of beneficial effects. These include relaxing blood vessels and improving their function. It     has been shown that following a meal with added nitrate, blood flow to the stomach increases     more than would be expected if the same meal is given without nitrate. This is because when     we eat nitrate the body concentrates it and recycles it through the digestive system. As it     cycles through it is converted into nitrite and nitric oxide which cause blood vessels to     relax. The nitrite and nitric oxide also seem to protect against infection from food sources     such as E.coli.      What we do not know is whether this nitrite and nitric oxide has any effect on the small     intestine and the liver. Some nitrite reaches the small intestine and may have the same     effect on blood flow there as it does in the stomach. This could be very important because     the small intestine releases hormones called incretins which we now know play a very     important role in controlling blood sugar every time we eat. These incretin hormones regulate     insulin release and the body's sensitivity to insulin. When we eat blood containing the     substances we have absorbed from the gut, such as sugars and fats, goes to the liver for     processing. The blood then leaves the liver and enters the circulation. This means the blood     supply to the liver will have much higher concentrations of nitrite than the blood     circulating in the rest of the body. High concentrations of nitrite appear to cause blood     vessels to open up. This means more blood vessels in the liver should be opened after a     nitrate rich meal. It seems likely that this will help the liver to control blood sugar more     effectively.      Purpose To find out if supplementation by inorganic nitrate as found in beetroot or green     leafy vegetables increases liver (hepatic) microvascular perfusion and increases incretin     secretion.      Plan of investigations:      We will recruit 16 individuals for each of the three groups (Young adults, older adults and     individuals with type 2 diabetes). Participants will be recruited from a database of     volunteers who have consented to being contacted for research studies which are held by the     NIHR Exeter Clinical Research Facility. This is a double blind, placebo controlled crossover     design study (nitrate rich beetroot juice vs a placebo, nitrate depleted beetroot juice).     Three visits will be required for participants to complete this study.      Visit 1. Screening and consent. The experimenter will explain to the participant what the     study is designed to test. If the participant is completely clear on the study and understand     what they are agreeing to, they will sign a consent form. In addition a standard medical     history and clinical examination will be undertaken by a research nurse and or Anthony     Shepherd. A venous blood sample will be taken using standard aseptic procedures. Following     consent participants will be assigned a study number. Study numbers will be previously     assigned (by a research statistician) to a randomisation order to begin either the beetroot     juice or placebo arm of the study first.      Visit 2. Visit 2 will require the participant to fast over night from 10pm. Only water will     be admissible from this time. The following morning participants will arrive at the     laboratory in a fully hydrated and rested state at ~ 7.30am. This visit will take ~ 5 hours     and will require 4 MRI scans. Participants will have the first MRI scan after a short     acclimatisation period. Participants will then be provided with a concentrated 140 mL nitrate     drink or placebo with a standardised breakfast (2 slices of toast with butter). Three     subsequent MRI scans will be required (one per hour for three hours). Venous blood samples     taken from cannulas will be sampled, in order to assess glucose, insulin, incretins and     nitrate/nitrite prior to each scan. Visit 3. Visit 3 will take place after a minimum washout     period of 7 days from Visit 2. Visit 3 will be identical in nature to visit 2; however, it     will be with the opposite supplement (either nitrate rich or placebo beetroot juice).      Impact:      Dietary nitrate appears to offer a simple, low cost means of modifying cardiovascular risk.     This study will deepen our understanding of the role of the nitrate/nitrite/nitric oxide     pathway in normal physiology. By understanding what effect inorganic nitrate from the diet     has on hepatic perfusion and other pathways involved in glucose homeostasis this may lead to     a range of simple, low cost therapeutic strategies to prevent and treat type 2 diabetes.   "
83832|NCT02188693|"     The primary purpose of our study is to evaluate whether gemcitabine as a single agent is     superior to observation in improving progression-free survival (PFS) in patients with     metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG     as their first-line treatment   "
83247|NCT02196363|"     Babies that are either very small or very big have increased perinatal morbidity and     mortality. Predicting which babies will fall into these groups is traditionally done with     risk assessment and third trimester manual palpation, however neither of these techniques are     sensitive and a considerable number of affected pregnancies are missed. This results in     stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third     trimester can improve detection rates but this is expensive and cannot currently be provided     to all NHS patients.      A more sensitive test that can be performed earlier in pregnancy would allow identification     of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound     techniques that measure volume and volumetric flow have become available that may allow this     to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant     women. The findings from these scans will then be correlated with actual birth weights at the     end of pregnancy to determine the ability of these parameters to act as screening tools for     babies at the extremes of size.   "
83248|NCT02196350|"     The study aims to assess the impact of the P4 approach on established markers of glucose     metabolism in type 2 diabetics.      Secondary objectives are examination of the changes in physical characteristics, quality of     life and the indices for beta cell function, hepatic insulin resistance and muscle insulin     resistance .   "
83249|NCT02196337|"     The purpose of this study is to determine whether universal salt iodization (USI) meets the     iodine requirements of pregnant women, lactating women and infants.   "
83250|NCT02196324|"     The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor     antagonist is safe and effective for treatment of prurigo nodularis versus placebo.   "
83251|NCT02196311|"     Patients treated with circular external fixation will have better outcomes (as measured by     range of motion (ROM), alignment, outcome surveys) than those treated with open reduction and     internal fixation (ORIF).   "
83252|NCT02196298|"     The Lokomat is a robotic treadmill gait trainer that is used to help people who have     neurologic conditions walk better. Early research with children with cerebral palsy (CP)     shows that it may help to improve walking skills. The purpose of this two-group randomized     study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on     walking abilities and related function. The primary (alternate) hypothesis is that children     will improve more with Lokomat training in terms of gross motor skills and walking endurance.      The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP     and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20).     In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done     first is decided by an independent randomization process that occurs after the first baseline     assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for     a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35     minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions,     and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities.     There is a 6 week break between the Lokomat and PT interventions.      Each child has four study assessments during their ~6 months in the study. The first     assessment is done before starting the Lokomat or physiotherapy phase. The second happens     after the first intervention has finished. The child then has a 6-week break period. The     third assessment is done at the end of this break, and the fourth occurs after the second     intervention. The PT assessor who does these assessments will not be the same as the PT who     gives the intervention. The assessor is blinded to the child's intervention phase and     previous assessment results. The primary outcome measures are the Gross Motor Function     Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities,     participation, health related quality of life and individualized goals.      The randomized aspect of the study lets us look at outcome differences between children for     Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase     evaluates within-child outcomes across the two phases. A qualitative component is     concurrently underway to examine child/parent experiences and their views of Lokomat     outcomes.   "
83253|NCT02196285|"     Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences     demonstrate the benefit for providing the universal access to vaccines containing measles and     rubella antigens, mainly due to, respectively, mortality in children and malformations in     fetuses. This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability     and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed     and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil,     for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated     and monitored for local and systemic adverse events and titration of antibodies. The study     will last 20 months in total.   "
83255|NCT02196259|"     Functional connectivity is defined as a correlation in neural activity between distinct     regions of the brain. Several recent studies have demonstrated areas of low-frequency     functional connectivity inherent to brain tissue at rest. These oscillations can be measured     using functional magnetic resonance imaging (fMRI) and appear to be synchronized between     related areas of the brain.      To date, no investigators have examined the effects of low-dose anesthesia on functional     connectivity. This study will image the human brain under conditions of rest, and low-dose     anesthetic induced sedation. Quality of the acquired signals will be evaluated and functional     networks in the brain will be examined. Of interest is whether administration of a low-dose     anesthetic disrupts functional connectivity in the brain, and whether a disruption of     functional connectivity is responsible for the reported analgesic and antidepressant effects     of a anesthetic.      Participation in the study includes four visits: an in-person interview, an initial fMRI     scan, the anesthesia infusion, and a second fMRI scan. There is an optional follow-up fMRI     scan one week post infusion.   "
83256|NCT02196246|"     To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination     of benign from malignant suspicious skin lesions or moles. Specifically the objective is to     demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to     identify lesions which are benign   "
83257|NCT02196233|"     Trigger finger is a condition commonly treated with surgical intervention, yet no specific     incision type has been associated with improved or worsened scar quality or outcome.     Therefore, the investigators objective is to determine if the incision type may affect the     results of operative treatment of trigger finger. Therefore, the goals of this study are as     follows:      Primary Objective: To directly compare incision type (transverse vs. longitudinal) for     trigger finger release with scar quality and patient satisfaction via a validated scar     evaluation scale.      Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for     trigger finger release to patient outcome via a validated upper extremity outcome score.   "
83302|NCT02195648|"     The main objective of this study is to determine the effects caused in neck movement, neck     pain, headache in patients with tension type headache and cervicogenic headache after     application of sub-occipital muscle inhibition technique associated with interferential     electrotherapy.   "
83258|NCT02196220|"     Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo     syndromes. These patients have a genetic enzyme deficiency that results in the inability to     degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell     enlargement and subsequent dysfunction. The accumulation occurs in all tissues including     cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits,     and various other orthopaedic manifestations [Van Heest, White]. These children often suffer     from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal     tunnel syndrome is almost always present, but may not become apparent until symptoms are     severe and loss of function has occurred. The current gold standard for diagnosis consists of     electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general     anesthetic [Khanna].      Primary Objective: The investigators plan to correlate EMG findings and median nerve     cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is     that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove     to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the     need for EMG studies and anesthesia.      Secondary Objective: The investigators want to determine the cross-sectional area of the     median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The     investigators plan to evaluate a cohort of healthy children to determine a normal     cross-sectional area of the median nerve.   "
83259|NCT02196207|"     This study will evaluate if inhibitors are reduced when Eloctate is begun in children with     severe Hemophilia A before the first bleed (preemptive) and continued weekly to prevent     bleeds (prophylaxis).   "
83260|NCT02196194|"     This prescription-event monitoring study was based upon 'event' monitoring and so capable of     identifying signals of events that might be associated with the use of tiotropium, which none     of the participating general practitioners (GPs) suspected to be an adverse drug reaction.     The methodology of this study readily permits follow up of specific events and the obtaining     of additional data as appropriate.   "
83262|NCT02196168|"     This randomized phase II trial studies how well cisplatin with or without WEE1 inhibitor     MK-1775 works in treating patients with head and neck cancer that has come back or has spread     to other parts of the body. Drugs used in chemotherapy, such as cisplatin, may prevent tumor     cells from multiplying by damaging their deoxyribonucleic acid (DNA), which in turn stops the     tumor from growing. WEE1 inhibitor MK-1775 may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. It is not yet known whether cisplatin is more     effective with or without WEE1 inhibitor MK-1775 in treating patients with head and neck     cancer.   "
83263|NCT02196155|"     Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for     health care and the temporary disability not only for work, plantar fasciitis results in a     substantial (and at least partially unnecessary) burden for the Swiss health care system and     national economics.      Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no     treatment has proven to be superior to others, and there is national and international lack     of consensus of how to treat plantar fasciitis best.      The investigators believe that the BTX-A injection in the gastrocnemius and the soleus     muscles is currently the most promising non-operative approach, because it is considered to     treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as     opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).      However, to date there is no evidence in the literature that compares the new, promising     technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and     to the gold standard steroid injection at the plantar fascia insertion site. With the     intended study, this gap is going to be closed.   "
83264|NCT02196142|"     To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol     addicted subjects.      Randomized, double-blind, placebo-controlled, cross-over, single administration of study     medication.      Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity     in alcohol dependent subjects.   "
83268|NCT02196090|"     Obsessive Compulsive Disorder (OCD) is a condition associated with recurrent intrusive     distressing thoughts, images and urges compelling the person to perform neutralizing acts or     thoughts to the extent of significantly interfering with their daily activities. The symptoms     of OCD are associated with both subjective and objective signs of distress. Treatment for     Obsessive Compulsive Disorder is often associated with significant subjective distress with     high dropout rates and often only limited improvement. Attempts to reduce distress in anxiety     often focus on re-establishing the sympathovagal balance by enhancing the vagal or     parasympathetic tone and it has been suggested that this can reduce the mobilization     behaviours of fight or flight response and improve emotion regulation. This study will     investigate the effect of a procedure potentially reducing distress and improving outcome of     treatment in inpatients admitted for treatment for OCD to the Anxiety Disorders Residential     Unit. The procedure will be based on increasing vagal tone by application of cold face mask     on 3 consecutive days in addition to the standard Exposure and Response Prevention therapy     (ERP).   "
83269|NCT02196077|"     This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five     treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The     overall objective is to demonstrate that the combination of budesonide (BD; PT008) and     formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides     benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.   "
83270|NCT02196064|"     To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin     elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the     combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a     single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus     (HCV)-coinfected subjects.   "
83271|NCT02196051|"     The purpose of this study is to examine the pathophysiology of insulin resistance and the     relation to the metabolic syndrome in humans.   "
83303|NCT02195635|"     To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the     pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to     administration of single-dose telotristat etiprate in healthy male and female subjects   "
83273|NCT02196025|"     Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that     has been approved as a treatment of depression in patients that have not responded to a trial     of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts     inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and     therefore is therapeutic. The investigators want to compare the change in insomnia scores     between baseline and end of treatment in an open label trial with bifrontal low frequency TMS     stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week     days).   "
83274|NCT02196012|"     The purpose of this study is to determine the feasibility and acceptability and efficacy of a     two month technology-based weight loss program for overweight and obese college students.   "
83275|NCT02195999|"     This study seeks to develop and validate non-invasive assessments of cardiac and respiratory     muscles with magnetic resonance imaging (MRI) to better predict the natural disease     progression of Duchenne muscular dystrophy (DMD) in affected individuals over time, as well     as determine whether peripheral skeletal muscle dysfunction can predict cardiopulmonary     dysfunction. The central hypothesis is that non-invasive MRI measures of the heart, muscle,     and peripheral skeletal muscles can sensitively predict future cardiopulmonary decline.   "
83276|NCT02195986|"     The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol     vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol     describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7     day treatment.   "
83277|NCT02195973|"     The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial     effects when combined with paclitaxel in women with platinum resistant ovarian cancer.     Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone     chemotherapy inclusive of a platinum compound (e.g. carboplatin or cisplatin).   "
83278|NCT02195960|"     Attention has been focused recently on the development of modalities that can protect healthy     organs from the harmful effects of radiation applied during different cancer treatment     schedules. As radiation-induced DNA damage involves oxidative stress, the protective role of     antioxidants has been tested in different dietary studies. Previous experience by the     collaborative team of the principal investigator and radiotherapists at the Catholic     University of Campobasso has shown in a retrospective study that moderate wine consumption     can reduce the side-effects of radiation therapy in patients with breast cancer. This effect     was presumably due to the polyphenol non alcoholic fraction of wine, a finding in agreement     with a cross-over intervention study in adult male volunteers, on protection by     de-alcoholized red wine from ex vivo radiation-induced DNA damage.      The purpose of this clinical trial will be to test the impact of supplementation with     anthocyanin-enriched food on the acute and medium-term side effects of radiotherapy in breast     cancer patients, in a prospective study design. Therefore a double blind, randomised,     placebo-controlled clinical trial will be organised by assigning patients with breast cancer     scheduled for radiotherapy to a diet supplemented with an anthocyanin soluble extract.   "
83279|NCT02195947|"     The effect of use of the growth hormone with antagonist protocol on the outcome of the     IVF/ICSI cycles in poor responders.   "
83292|NCT02195778|"     Health Literacy is the ability to understand health information and to use that information     to make good decisions about health and medical care. Health informatin can overwhelm even     people with advanced literacy skills. About one third of the adult population in the United     States has limited health literacy.   "
83311|NCT02195531|"     The study hypothesis: in groups receiving tailored education and feedback in a style that     matches their psychological profile, will show a higher CPAP adherence rates than groups     receiving mismatched tailored education / feedback, and groups that receive no tailored     education and feedback (standard of care).   "
83280|NCT02195934|"     This study aims to compare the effect of an anthocyanin-rich blood orange juice with a     standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD).      Participants aged between 25 and 84 years of age will be recruited into a single arm, two way     cross-over study based on their waist measurement, with 42 individuals required to complete     the study. Participants will each receive two interventions in a randomised order: 500mL     blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28     days.      Prior to each intervention there will be a 2 week run in period where participants will be     asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention     period, there will be a 3 week wash out period after which the participants will be asked to     then drink the other juice for 28 days. The 500 mL of blood orange juice contains     approximately 50mg of anthocyanins, whereas the standard juice contains none.      Blood samples will be collected for the preparation of plasma and peripheral blood     mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations,     transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion     of anthocyanin metabolites will be quantified. Other measurements will include pulse wave     analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood     glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements     using the TANITA machine which include weight, fat mass, muscle mass, fat percentage,     fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat     rating, and degree of obesity. All measurements and samples will be taken at baseline and     post intervention for each phase of the study.   "
83281|NCT02195921|"     The purpose of this study is to clarify whether the matching acupoints is more effective than     a single point by electroacupuncture in the management of chemotherapy-induced nausea and     vomiting .   "
83282|NCT02195908|"     The purpose of this study is to clarify whether the matching acupoints are more effective     than a single point by electro-acupuncture in the management of chemotherapy-induced nausea     and vomiting .   "
83283|NCT02195895|"     The purpose of this study is to determine if a year of alendronate treatment will maintain or     increase bone mass density (BMD) compared to baseline BMD values in people with chronic SCI.      This study will also investigate 1) if alendronate therapy will increase bone strength in     people with chronic SCI, 2) the safety of alendronate, and 3) the effects of alendronate on     serum markers of bone metabolism.   "
83284|NCT02195882|"     The purpose of this study is to determine whether a specific strengthening program for the     stabilizing scapular muscle can reduce shoulder pain of amateur kayaker.   "
83287|NCT02195843|"     Heart failure is the most rapidly growing cardiovascular condition in developed countries.     Despite advances in medical therapy, patients with heart failure are at high risk for death     and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an     effective treatment for heart failure.      Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV     lead cannot be implanted in patients undergoing a trans-venous system implantation. In this     case, the patients may undergo multiple procedures before a lead is successfully implanted.     These implant failures are not due to patient selection but rather to patients heart anatomy     leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic     stimulation) and poor electrical measurements.      The phrenic nerve is not part of the heart but runs near to this area on the way to a large     muscle, called diaphragm, which separates the lung space from the space containing stomach,     liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to     this nerve, it can cause a small part of it to contract giving you an uncomfortable     hiccupping sensation.      In many patients, phrenic nerve stimulation is not identified until after the implant     procedure when movement and postural changes bring the LV lead into closer contact with the     phrenic nerve.      The investigation is performed to demonstrate the equality of performance of two different     modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical)     optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.   "
83288|NCT02195830|"     There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid     volume status in patients with sepsis.      To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we     first need to define the inferior vena cava collapsibility index in this population of     patients.      The research question is: In adult patients with sepsis, severe sepsis and septic shock what     is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid     resuscitation.   "
83289|NCT02195817|"     To determine the reduction in alcohol consumption in patients with alcohol dependence treated     with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in     primary care   "
83290|NCT02195804|"     The objective of this study is to establish the relative bioavailability (BA) of two     different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over     the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation     following oral single dose administration in fasting healthy male volunteers   "
83291|NCT02195791|"     Pioglitzone, an oral anti-diabetic drug which can reduce insulin resistance and decrease     inflammation. It has been proven to be an effective neuroprotective agent in animal model of     ischemic stroke. In this study, the investigators will conduct a phase II clinical trial     (double-blind, randomized placebo controlled study) to survey the neuroprotection effect of     pioglitazone in stroke patients with hyperglycemia. A total of 152 acute ischemic stroke     patients with hyperglycemic will receive insulin or sulfonyurea for blood sugar control, and     will be randomly randomized into intervention (Pioglitazone 30mg once a day p.o,) and control     group (placebo). The investigators expect to prove the neuroprotective efficacy of     Pioglitazone in acute stroke with hyperglycemia and identify the biomarkers associated with     good neurological outcome in patients with Pioglitazone treatment from the investigators     clinical trial.   "
83478|NCT02193321|"     The purpose of this study is to to evaluate the rate of new onset postoperative atrial     fibrillation in subjects receiving the amniotic membrane patch placed on the epicardial     surface as compared to subjects who did not undergo epicardium intervention.   "
83294|NCT02195752|"     A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients     prescribed compounded pharmaceutical creams for the treatment of pain. The project is     designed to accumulate tracking information from both patients and physicians over the course     of therapy as a supplement to the ordinary care that the patients will normally receive. We     seek to discover aspects of successful and unsuccessful treatment using topical pain creams.     This information will be analyzed and reports prepared of observations and emergent findings.     These reports will be sent during the study every 1 or 2 months to patients, physicians and     pharmacists who are participating in the Study. A final compilation of findings and     observations will be circulated to participating patients, physicians and pharmacists.   "
83295|NCT02195739|"     The aim of this study is to compare the cardiovascular disease event rate in smokers     undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group) with     the event rate in smokers attempting smoking cessation assisted by pharmacological     interventions - by nicotine replacement therapy (as any, or a combination, of: nasal spray,     transdermal patches, inhaler or gum and tablets) or other pharmacological smoking cessation     aids (e.g. bupropion [Zyban®] and varenicline [Champix®]) - in a representative UK primary     care population.   "
83296|NCT02195726|"     The purpose of the present study is to determine if remote ischemic preconditioning reduces     incidence of acute kidney injury in patients with reduced kidney function undergoing     Percutaneous Coronary Intervention.   "
83297|NCT02195713|"     Urine output and urine drain line pressure were monitored while urine was drained into     either:        1. Accuryn Urine Output Monitor (Potrero Medical) OR        2. Criticore Monitor (Bard Medical)   "
83298|NCT02195700|"     The purpose of this study is to determine whether an investigational drug, SD-809     (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive     dyskinesia.   "
83299|NCT02195687|"     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared     with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).   "
83300|NCT02195674|"     The purpose of the EMBARK Follow-up Project (EFP) is to determine if there is a significant     correlation between post-study massage-seeking and changes in pain reported by participants     during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study     (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief     during the parent study and post-study massage-seeking behavior.   "
83301|NCT02195661|"     This study aims to determine the safety and effectiveness of oral melatonin as natural     inducer of sleep to acquire useful EEGs in South African children following its introduction     as the main agent used in the Neurophysiology department at Red Cross Children's Hospital.     This is an observational retrospective study.   "
83306|NCT02195596|"     A program that combines high intensity aerobic exercise (<85% of Heart Rate Reserve) with     resistance, progressive and moderate intensity intervals, carried out in primary care, is     effective in terms of a smaller increase in respect to the baseline measurement in the total     score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive section),in     the control group that receives an intervention similar to low intensity (30-40% of Heart     rate reserve).      We Expect a difference of at least 3 points between the means of the increments between the     intervention and control group.   "
83307|NCT02195583|"     This study will evaluate the effect of experimental sodium fluoride-silica dentifrice     formulations, with and without zinc, on remineralization of enamel in situ. Following the     remineralization phase, the acid resistance of the new mineral formed will be assessed.     Fluoride uptake during the remineralization phase will also be measured.   "
83308|NCT02195570|"     The long-term goal of this research is to reduce tobacco-related disparities in maternal and     infant health outcomes by improving smoking cessation and relapse prevention interventions     for minority pregnant and postpartum women, who have been significantly underrepresented in     smoking cessation research. This study will examine the feasibility and efficacy of a     prize-based contingency management approach for increasing smoking cessation and preventing     relapse among socioeconomically disadvantaged minority pregnant smokers. First, the     intervention will be pretested with 10 pregnant low-income minority smokers and then refined     based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60     highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a     large teaching hospital, who report daily smoking and who meet other eligibility criteria     will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational     Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now     curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational     Intervention plus Contingency Management (provision of incentives contingent on     biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide     and salivary cotinine levels will occur in both groups beginning on the first quit day and     continuing through 3-months postpartum. Only participants in the QSN-CM group will be     reinforced for biochemically-verified abstinence with chances to win prizes ranging in value     from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be     assessed through follow-up research exams (delivery and 6-months postpartum) and hospital     chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition     will have higher rates of abstinence during pregnancy and postpartum compared to women     receiving standard of care alone. Results should advance scientific knowledge regarding     effective methods for promoting and maintaining smoking abstinence among pregnant     disadvantaged women and provide preliminary feasibility and efficacy data needed to support a     larger randomized controlled trial.   "
83309|NCT02195557|"     Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among     the patients with knee osteoarthritis (OA) since at least three years.   "
83310|NCT02195544|"     Study of prescription methods in everyday medical practice, tolerance profile and effect of     Synvisc® until six months of follow-up.   "
83312|NCT02195518|"     This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF     in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues     (NAs). The study will enrol 200 CHB subjects following failure of multiple NAs. Subjects will     be assessed for eligibility at a screening visit, with eligible subjects returning for a     baseline assessment after approximately 4 weeks (Screening phase). In the treatment phase all     enrolled subjects will receive open label TDF at a dose of 300 milligrams (mg) orally once     daily. All the eligible study subjects will undergo safety and efficacy assessments every 12     weeks for a total of 14 visits. Tenofovir disoproxil fumarate, the oral pro-drug of tenofovir     (TFV), is a nucleotide analogue that inhibits viral polymerases by direct binding and after     incorporation into deoxyribonucleic acid (DNA), by termination of the DNA) chain. TDF is a     highly potent treatment in treatment-naïve and lamivudine (LAM) resistant CHB patients. The     purpose of our study is to evaluate the efficacy of TDF treatment in Chinese CHB patients     following failure of multiple NAs. In addition, the study will also explore the relationship     of baseline factors and early HBV DNA suppression to long-term virological response. The     efficacy of TDF in multi-drug resistant patients will be analysed separately. The data     generated by this study could then be used to optimize the clinical application of TDF and     provide new evidence for management of the HBV infections following failure of multiple NAs.     The result of this study will help Chinese physicians better manage the CHB patients     following failure of multiple NAs.   "
83313|NCT02195505|"     The USAGE study aims at assessing on a long-term period (two years in average) the outcome in     clinical or economical term of patients with knee osteoarthritis (OA) treated or not with     Synvisc®, in the 1139.4 clinical trial.   "
83314|NCT02195492|"     Retrospective collection of data, aimed at a better knowledge of the context of use of     Synvisc® among the patients practising a regular activity (professional/leisure), and at     evaluating the different practices and their results.   "
83315|NCT02195479|"     The purpose of this study is to determine if the addition of daratumumab to velcade     (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared     with VMP alone in participants with previously untreated multiple myeloma who are ineligible     for high dose chemotherapy and autologous stem cell transplant (ASCT).   "
83316|NCT02195466|"     Study to determine the effects of single-dose and steady-state TPV/RTV 500/200 mg on the     steady-state pharmacokinetics of fluconazole   "
83317|NCT02195453|"     The purpose of this study is to observe quality of life and treatment side effects in     patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and     Yangzhengxiaoji capsule.   "
83318|NCT02195440|"     The purpose of this study is to investigate the safety and tolerability of PRI-724 in     patients with HCV-induced cirrhosis.   "
83319|NCT02194842|"     The objective of this randomized phase III open label trial is to assess if upfront     combination of enzalutamide and Ra223 improves radiological progression-free survival     compared to enzalutamide single agent in asymptomatic or mildly symptomatic castration     resistant prostate cancer patients metastatic to bone.   "
83354|NCT02195076|"     The investigators have developed an early detection solution for lung and breast cancer. A     system which can distinguish between different medical odors based on biosensors. Our product     is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The technology     enables a high level of sensitivity and provides users with a quick lab response and a simple     yes or no answer.      The aim of this study is to contribute and detect the patient at the earliest possible stage,     in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples are a     promising approach towards future possible lung and breast cancer screening method.   "
83320|NCT02194829|"     This partially randomized phase I/II trial studies the side effects and best dose of WEE1     inhibitor MK-1775 when given together with paclitaxel albumin-stabilized nanoparticle     formulation and gemcitabine hydrochloride and how well they work in treating patients with     previously untreated pancreatic cancer that has spread to another place in the body or cannot     be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized     nanoparticle formulation and gemcitabine hydrochloride, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. WEE1 inhibitor MK-1775 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. It is not yet known whether paclitaxel     albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride are more effective     with or without WEE1 inhibitor MK-1775 in treating patients with pancreatic cancer.   "
83321|NCT02194816|"     We are trying to identify factors associated with improved quality of life and fewer PD     symptoms. We are attempting to identify practices, beliefs, and therapies used by individuals     who report excellent quality of life, few PD symptoms, and reduced rates of progression.     After agreeing to participate, we will ask participants to fill our questionnaires about     their experience with PD, their health in general, along with their food intake every six     months for five years.   "
83322|NCT02194803|"     A multicentre, open-label, non-interventional study to observe treatment patterns in patients     with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic     macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to     chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal     injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months     observational period under real life conditions.   "
83323|NCT02194790|"     Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have     demonstrated that integrated pre-dialysis care may slow the decline in renal function     (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early     intervention especially in high risk groups like Diabetic may also improve outcome of these     patients in primary health care setting resulting in delay of CKD progression.   "
83324|NCT02194777|"     The objective of the present study is to obtain information about the safety, tolerability     and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing     doses in healthy male and female volunteers   "
83325|NCT02194764|"     The purpose of this study is to develop a cost-effective breath-based medication adherence     monitoring system that can monitor whether recovering opiate addicts actually take a specific     treatment medication called naltrexone.   "
83326|NCT02194751|"     This Phase II trial studies the overall tumor response of vaccine therapy in patientswith     previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The     vaccine contains an extract of the patient's own cancer cells and the immunostimulant     protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine     will enable the patient's immune system to recognize and destroy the cancer cells. The trial     will also assess the safety of the vaccine, the time from vaccine treatment until the patient     requires another type of anti-lymphoma treatment, progression-free survival, and the     anti-tumor immune response.   "
83328|NCT02194725|"     Background:      - Children with Duchenne/Becker Muscular Dystrophy (DBMD) slowly lose muscle function. They     usually die at a young age. Some mothers adapt to the demands of caring for a child with this     disease better than others. Studies show that a person s hope may positively affect how they     cope and adapt. Researchers want to find out more about this. They want to develop ways to     improve caregivers overall wellness.      Objective:      - To study the relationships between uncertainty, hope, and coping ability in mothers of     children with DBMD.      Eligibility:      - Women in the United States 18 years and older. They must be biological mothers of a living     child with DBMD and be able to answer a survey in English.      Design:        -  This study is part of a larger study that examines the well-being of mothers with sons          who have DBMD.        -  Participants will take a questionnaire. The questionnaire can be done on paper or on a          computer. It will take 30 45 minutes to complete.        -  The questionnaire will include basic demographic questions about the participant and the          child. There will also be questions about how the participant copes with the stress and          uncertainty of DBMD.        -  For most of the questions, participants will rate their feelings on a scale. There will          also be four open-ended questions.   "
83329|NCT02194712|"     Schistosomiasis is increasingly encountered among travellers returning from the tropics and     is known for its focal endemicity, associated with the presence of the snail intermediate     host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic     due to the low intensity of infection, many infections likely go undiagnosed and will develop     into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with     praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of     schistosomiasis relies on egg detection, which has a poor sensitivity in low burden     infections, or serology, which is inadequate to monitor cure. The department of parasitology     of the Leiden University Medical Center has developed a novel diagnostic test based on the     up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test     can be performed on serum and urine to detect low intensity schistosomiasis infections and     confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA     in travellers with high-risk water contact.   "
83330|NCT02195414|"     The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will     enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical     feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold     in the treatment of patients with de novo coronary lesion.   "
83355|NCT02195063|"     This is a survey study that will be given to patients who have been prescribed a topical     compound for pain management, wound care or scar care or to patients who have been requested     to do a urinary drug test (UDT) by their provider.      The initial survey for pain management, wound care, scar care or UDT will be given to the     patient by their providers during their office visit.   "
83923|NCT02187510|"     The purpose of this study is to determine whether the umbilical cord milking in preterm     infants born by cesarian section less than 34 weeks is more effective than delayed cord     clamping to obtain higher levels of hemoglobin.   "
83331|NCT02195401|"     A child and their parent were asked to participate in a research project that sought to study     whether sleeping in a very clean environment for 14 days improved the elimination of     chemicals and metals from the child's body. The child had an approximately two hour     evaluation to confirm his or her diagnosis of Autism or Pervasive Developmental Disorder. Not     Otherwise Specified. When one of these diagnoses was confirmed the child was scheduled to     spend 14 nights sleeping in a very clean environment in a specially created room at The     Children's Institute.      Several hours prior to the first night the child slept in the clean room the child's mother,     father, or guardian filled out behavioral rating scales about the child with the assistance     of the study's research coordinator. The child also had approximately two tablespoons of     blood drawn from an arm and a few inch sample of hair was taken from the back of the child's     head. The child and a parent or guardian arrived at The Children's Institute about one half     hour prior to the child's normal time of settling for bed for 14 consecutive nights. The     child and a parent or guardian slept in the clean room, wearing the provided very clean     clothes and sleeping on special mattresses and sheets each night for 14 consecutive nights.     The child and parent were observed by a nurse through a window during the time in the clean     room. The child and parent participated in regular daytime activities during these 14 days of     the study. On the morning after the last night the child and a parent or guardian slept in     the clean room a parent or guardian filled out behavioral rating scales with the help of the     research coordinator. Approximately two tablespoons of blood were drawn from an arm and a few     inch sample of hair was obtained from the back of the child's head, at The Children's     Institute or at home.   "
83332|NCT02195388|"     Myocardial infarction is related with endothelial function, arterial stiffness and autonomic     nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is     also related with endothelial function, arterial stiffness and autonomic nervous system     dysfunction.      Primary aim of study is to investigate how complex cardiac rehabilitation influence     endothelial function, arterial stiffness and autonomic nervous system activity according to     presence or absence arterial hypertension.      Secondary aim is to obtain correlation between methods for the assessment of particular     disorders and intercorrelation between different disorders for example endothelial function     and autonomic nervous system activity.   "
83333|NCT02195375|"     The purpose of this study is to investigate whether flutiform® is effective and safe in the     treatment of chronic obstructive pulmonary disease (COPD).   "
83334|NCT02195349|"     This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled,     single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized Antibody     Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific     to the Lymphocyte Activation Gene-3 (LAG-3) protein. This is the first administration of     GSK2831781 in humans and will evaluate in two parts the safety, tolerability,     pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV doses of     GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette     Guérin (BCG) (Part A delayed type hypersensitivity [DTH] cohorts) and patients with plaque     psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the mechanism in     biopsies and clinical response endpoints in these populations, as well as investigate     systemic biomarkers will provide useful information prior to conducting studies in other     immune-inflammatory disease which will involve more invasive tissue biopsies. Measuring the     pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from     Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin biopsies from     patients with psoriasis, will be helpful in understanding of the dose response relationship,     which will be important for designing future studies in immuno-inflammatory diseases,     including psoriasis. Approximately 67 subjects will be enrolled to complete dosing and     critical assessments. The subject numbers will be split to approximately 40 healthy subjects     (Part A) and 27 patients with psoriasis (Part B).   "
83346|NCT02195193|"     The overall goal of this study is to develop, pilot test, implement, and evaluate a     nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes     (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost     in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS     patients from 20 rural county hospitals selected from a well-established research network     across China.   "
83479|NCT02193308|"     To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose     combination (FDC) vs. its monocomponents   "
83335|NCT02195336|"     To date, there are no methods to reliably select which patients with non-squamous non-small     cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown     that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in     some tumour types, including advanced NSCLC.      Recent data are suggestive of a predictive value of imaging techniques for early detection of     antiangiogenic treatment efficacy in different cancers. To our knowledge there are no     presented data available on correlation between changes in diffusion-weighted MR and response     to bevacizumab treatment in lung cancer. The current study is designed as a pilot study to     prospectively investigate changes in MR variables during treatment with bevacizumab and to     detect signals of prognostic and/or predictive value of MR changes during treatment.   "
83336|NCT02195323|"     This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)     therapy in chronic kidney disease (CKD).   "
83337|NCT02195310|"     The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS)     versus standard wound care for the incision in subjects undergoing a sternal midline incision     (sternotomy). The subjects targetted for the study are at high risk for surgical     complications (like infections) around the environment of the incision.      The study is conducted in The Netherlands, Germany and Austria.   "
83338|NCT02195297|"     Aim of this study was to evaluate by clinical, morphometric and non invasive instrumental     evaluations the activity of an anticellulitis cosmetic product vs a reference product of     the market (comparison within subjects), applied once a day, for an uninterrupted period of 4     weeks, on 22 female healthy volunteers with low/moderate oedematous - fibrosclerotic     lipodystrophy on the thighs.      It was also aim of the study to evaluate cosmetic acceptability by the volunteers and     products efficacy and tolerance both by investigator and volunteers.   "
83365|NCT02194933|"     The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic     resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by     impulsive behavior.   "
83366|NCT02194920|"     The purpose of this study is to evaluate safety and effectiveness of normal parathyroid     tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of     parathyroid gland during thyroid surgery.   "
83464|NCT02193503|"     The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1,     administered sub-cutaneously (injections and capsules implantations), in patients with     advanced metastatic solid tumor in progression who are not or not any longer amenable to any     standard therapy of their tumour disease.   "
83339|NCT02195284|"     This study is designed to assess the proportion of asthma subjects making critical and     non-critical errors made in using ELLIPTA® inhaler compared with other commercially available     inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and DISKUS/ACCUHALER®.     This study will also assess the ease of use and preference between the ELLIPTA inhaler and     the other commercially available inhaler devices. This is a randomized, open-label, placebo,     crossover, multicentre study with a single visit. The study will comprise three sub-studies.     Subjects will receive inactive treatment (placebo) via the ELLIPTA inhaler and one of the     other inhaler devices depending on the sub-study they are allocated to. Only subjects who are     naïve to the ELLIPTA inhaler and to one of the other inhalers that will be used in this study     will be included. The study will be conducted in the Netherlands and the UK, and comprises     one visit only. A sufficient number of subjects (at least 190) with asthma will be screened     and 180 will be randomized to one of the three sub-studies. Eligible subjects will be     allocated to one of the sub-studies in the following order depending on their experience of     using the other inhaler (i.e., depending on which other inhaler they are naïve to).      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.     TURBUHALER is a registered trademark of AstraZeneca.   "
83340|NCT02195271|"     Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is is     associated with a wide range of diseases and their social consequences is a public health     problem.      With the progress of neuroscience and studies on the plasticity of the central nervous     system, it has been provided a better understanding of the neurobiological mechanisms of     pain.      The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both     in physiological and pathological situations, with modulating effects on the process of     nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and     GABAergic, exerting anti-inflammatory action, analgesic activity among others.      The advent of neuromodulation techniques such as transcranial direct current stimulation     (tDCS), which promote changes in neuronal activity and signaling to be effective in     conditions of chronic pain by attenuating changes in cortical excitability.      There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus,     considering the potential for each isolated intervention and the lack of knowledge of their     combined effect, the authors propose the present study to investigate the effect of this     combination on the heat-pain detection threshold and the neuroplasticity in the healthy     subjects.   "
83341|NCT02195258|"     this study is designed to identify the genetic factors which can be implicated in the     salbutamol responsiveness for asthmatic children in pediatric emergency department   "
83342|NCT02195245|"     CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose     problems as the chemical granulate reacts not only with the CO2 but also the anesthetic     drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the     problem of organ-toxin production in anesthetic circuits.   "
83343|NCT02195232|"     This research study is evaluating a drug called isoquercetin to prevent venous thrombosis     (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal     cancer.   "
83344|NCT02195219|"     The aim of this study is to compare two therapeutical procedures for the grade III     acromioclavicular dislocations, either open reduction and internal fixation with a     coracoclavicular device (MINAR-STORZ ) or non operative treatment.      For these purpose we have designed an interventional, prospective, parallel assignment,     opened and randomized study.   "
83345|NCT02195206|"     In this pilot study, MRI of the lungs of healthy adult volunteers will be performed at 1.5     Tesla to assess image quality using a prototype chest coil and pulse sequence following     inhalation of hyperpolarized 129Xe (xenon) gas. This study will take place at the Hospital     for Sick Children, Toronto, Canada. Twenty subjects aged 18 to 75 will participate in this     study. Xenon MRI is a non-invasive imaging technique that does not involve X-rays or ionizing     radiation. Rather, this imaging method utilizes the same hardware and software principles     that are used for conventional proton MRI of patients in a hospital. The investigators are     testing the abilities of xenon MRI to see if it will produce lung images of equal or better     quality to that of proton MRI.      The investigators hypothesize that they will get good quality images of the lungs for     analysis using our method.   "
83374|NCT02194673|"     Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and     insulinemic responses compare to a trans free palm margarine (TFPM).   "
83347|NCT02195180|"     A new approach that aims to destroy pancreatic tumor cells through modification of the tumor     environment.      Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an     essential nutriment for pancreatic cancer cells which have no or low level of ASNS.      by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.      in selected patients having no or low ASNS, may provide a new therapeutic approach.   "
83348|NCT02195167|"     Pediatric PK study of SEP-225289 (Dasotraline)   "
83349|NCT02195154|"     Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the     study. Each evaluable subject involved in this study must fulfill all the inclusion and     exclusion criteria and each subject will have 3 visits in the study, as one screening visit,     one imaging visit, and one safety evaluation visit.   "
83350|NCT02195141|"     Pathological complete response, (pCR) correlates with a favorable overall prognosis in     locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a     pCR might be beneficial. The aim of the study is to investigate safety and efficacy of     preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological     complete remission rate.   "
83351|NCT02195115|"     The goal of this study is to challenge the existing clinical practice of employing     laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a     regimen of active non-surgical therapy.   "
83352|NCT02195102|"     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve     Replacement (TAVR) in the Asian Pacific population   "
83353|NCT02195089|"     The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for     the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).   "
83465|NCT02193490|"     The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase     eye drops in patients with Sjogren's and Non-Sjogren Dry Eye Disease.   "
83356|NCT02195050|"     1. At target LDL-C levels, apoB100 concentrations will be higher than recommended levels in          the following populations:             1. Tertiary centre lipid clinic patients with raised TG treated with statins.             2. Patients with type 2 diabetes treated with statins.             3. Patients with Chronic Kidney disease (CKD) stages 4 and 5 treated with statins.        2. Despite achieving LDL-C and non-HDL-C targets, a significant number of statin-treated          patients have residual cardiovascular risk related to raised hsCRP. The relationship          between hsCRP and Lp-PLA2 (markers of inflammation) and LDL particle number measured by          apoB100 is stronger than that of measured and calculated LDL and non-HDL. In statin          treated patients there will be higher levels of hs-CRP and Lp-PLA2 in patients achieving          LDL targets but not apo B targets.        3. We hypothesise that non-diabetic patients with severe hypertriglyceridaemia (fasting          serum triglyceride >5.5 mmol/l) have evidence of greater nerve damage compared with          matched controls.        4. LAL deficiency is underdiagnosed in patients with severe hypertriglyceridaemia, low          HDL-C, hyperlipidaemias, non alcoholic fatty liver disease and idiopathic high liver          enzymes.   "
83357|NCT02195037|"     Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay     of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the     newborn to receive his/her own blood from the placenta (placental transfusion) which helps     their transition in the first hours of life. The purpose of the study is to learn about the     amount of blood flow to and from the baby's heart during normal newborn transition   "
83358|NCT02195024|"     Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI)     in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker     system, to assess MR-image quality and to prove the safety of MRI in this specific population     in the short term as well as during long term follow-up.   "
83359|NCT02195011|"     The purpose of this study is to determine the safety of regorafenib, an antiangiogenic drug,     when combined with radioembolization using SIR-Spheres® microspheres in the treatment of     colorectal cancer (CRC) that has spread to the liver.   "
83360|NCT02194998|"     HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and     routes of transmission. For this reason, many people infected with HIV are also infected with     HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and     HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose     of this study is to evaluate the safety, tolerability, and effectiveness of IFN-free HCV     treatment in HIV/HCV coinfected adults who are taking antiretroviral (ARV) therapy.   "
83361|NCT02194985|"     This is an open-label extension study intended to provide continued treatment with migalastat     HCl for subjects with Fabry disease who completed treatment of a previous migalastat HCl     monotherapy study.      The study will assess the long-term safety and effectiveness of migalastat HCl in subjects     with Fabry disease who completed migalastat HCl treatment in a previous study.   "
83362|NCT02194972|"     The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary     fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with     slow-transit constipation.   "
83397|NCT02194374|"     Gene transfer is a process in which the DNA (genetic material) of certain cells is changed.     In this study, gene transfer will be performed on a type of white blood cell (called T cells)     to recognize leukemia cells in the same person the T cells were collected from.      The goal of this clinical research study is to learn if it is safe to give these     genetically-changed T cells back to patients with CLL/SLL. Researchers also want to learn if     these cells can help to attack CLL/SLL cells.   "
83363|NCT02194959|"     Cancer health disparities related to race and ethnicity are among the most serious problems     facing the US health care system. A recent institute of medicine report stated that such     disparities are seen at every level of health care, from prevention to treatment and     follow-up. This problem is acutely evident in the figures for colorectal cancer (CRC) among     African Americans. According to the American cancer society, African Americans have the     highest CRC incidence and mortality of any ethnic/racial group. Indeed, CRC incidence and     mortality are 15% and 43% higher among African Americans than whites, respectively. These     disparities could be effectively reduced through greater African American participation in     CRC screening and early detection. More importantly, due to the preponderance of CRC in     African Americans beyond the reach of the flexible sigmoidoscopy (1), increased adherence to     colonoscopy among African Americans will save lives. Although there is clear evidence that     providing patients with someone to help them manage/navigate the health care system (i.e.,     patient navigation (PN)) is effective in helping them to complete cancer screening, very few     hospitals provide PN for colonoscopy. The vast majority of hospitals in NYC are unable to     provide PN for patients for whom colonoscopy is recommended, in large part because of the     costs associated with professional-led PN. This project seeks to address this serious public     health problem by investigating the success of training African Americans who have undergone     colonoscopy to serve as volunteer peer patient navigators to encourage others from their     community to complete CRC screening via colonoscopy.   "
83364|NCT02194946|"     Stage 5 chronic kidney disease (CKD), also end stage renal disease(ESRD), usually presents     overt clinical symptoms and is a critical stage when patients are encountered with dialysis.     The optimal time to initiating dialysis in patients with stage 5 CKD is addressed as the most     important dialysis-related question. As indicated by the recently published European Renal     Best Practice (ERBP) guideline, early initiation seemed to produce no benefit but greater     expenditure and sometimes more harm.Renal replacement therapies (RRT) including dialysis are     the most common procedures for patients with end-stage renal disease (ESRD), but conservative     management should be an option in patients who still experience the stable period without     clinical indications of dialysis.Chinese Medicine (CM) is recognized as an alternative     therapy on alleviating uremic symptoms, deferring dialysis initiation, and improving quality     of life. Although the effects of CM on kidney disease have been demonstrated in animal     experiments, evidence from large clinical trial is insufficient. So we raise the hypothesis     that CM therapies including Chinese herbal formula, Chinese patent medicine via oral pattern     and/or Colonic administration, will defer the initiation of dialysis in adults with stage 5     CKD.   "
83367|NCT02194907|"     This study will determine whether brain activity can be modified and improves performance on     a task by showing participants live 'video feed' of their brains on advanced imaging     technology. The study is particularly interested in brain regions that have been shown to be     relevant for emotions, specifically the anterior insula and the medial prefrontal cortex.     Advanced technology will map the brain using magnetic pulses with a real-time functional     Magnetic Resonance Imaging (rt-fMRI) machine.   "
83368|NCT02194894|"     In this first pilot study, we will examine the effects of acetaminophen dosing in adult     patients with NAFLD in comparison to the effects in a healthy control group. Both groups will     receive 3 grams (g) of acetaminophen, the maximum recommended daily dose, daily for 14 days.     We hypothesize that NAFLD patients are more prone to APAP toxicity than normal     controls.Treatment will be stopped after two weeks or in the following conditions:      Treatment with APAP will be stopped in healthy volunteers if ALT and/or AST reached three     times the ULN. In patients with NAFLD, treatment will be stopped if: ALT or AST reach ≥ three     times the upper limit of entry value or ≥ 5 times the ULN; or if there is ALT or AST >3 times     ULN and TBili >2xULN or INR >1.5; or if there is ALT or AST >3 times ULN with the appearance     of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or     eosinophilia (>5%). We follow a conservative approach derived from the FDA guidelines for     stopping medications expected to cause drug induced liver injury (DILI). Indeed, the FDA     allows continuation of the medication until ALT or AST are >8x ULN in the absence of elevated     Tbili or INR. Patients who have hepatotoxicity will have close monitoring of their liver     enzymes until they normalize. Taking acetaminophen up to 3g daily has been shown to be safe     and acceptable. We have followed very strict criteria for monitoring and stopping rules     however in the usually cases of toxicity the patient will be admitted for monitoring.   "
83369|NCT02194881|"     The purpose of this study is to determine whether the treatment with Ivacaftor remains     effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR     mutation) in the real life setting, after the drug has been approved by the Health     authorities.   "
83370|NCT02194868|"     The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution     in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to     set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk     according to the quantity and functionality   "
83371|NCT02194855|"     The investigators investigated whether laparoscopic versus open surgical approaches affected     the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or     cisatracurium.   "
83372|NCT02194699|"     A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3     Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with     Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist   "
83373|NCT02194686|"     1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely          associated with coronary risk factors and atherosclerotic diseases.        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of          cilostazol on human early EPCs and endothelial function as well as the potential          mechanisms of action in patients with high risk for cardiovascular disease.   "
83375|NCT02194660|"     Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its     Beihu Branch (BB).      Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13     'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan     University Hospital (NTUH) health care system. The main hospital (MH) program enrolled     patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3)     clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB)     program enrolled only the later two types of patients from outpatients. During the whole     study period, two programs planed to enroll 600 fracture patients. Each patient would be     assessed at baseline, and every 4 month for at least one year.   "
83376|NCT02194647|"     BACKGROUND:      One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent     years, efforts have been made to change the delivery of these medications from oral form to     injection form every, 3, 6 or 12 months to increase adherence. However, both patients and     providers are sometimes confused about the multiple choices. Also, patients may receive extra     medications if providers did not keep tract of their previous AOM uses or patients may     changes providers. There were urgent needs to provide AOM monitoring and management services     to improve cares.      OBJECTIVES:      To establish a anti-osteoporosis medication management service at National Taiwan University     Hospital and its BeiHu Branch.      METHODS:      Participating physicians will select those eligible for services and refer to study     coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture     risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,     sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic     visit, telephone reminder and follow up for patients, and communicate with providers on     regular bases. the investigators plan to enroll 500 patients with 18-month follow up for     each.   "
83377|NCT02194634|"     This study is designed to assess safety and efficacy of intravitreal injection of Conbercept     on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .   "
83378|NCT02194621|"     The primary objective was to evaluate the antibacterial effects of two toothpastes containing     0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a     control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days     of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3%     triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in     silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial     efficacy that is equivalent to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234%     sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option     2) after 13 days of product use.   "
83379|NCT02194608|"     The primary goal is to evaluate whether a home telehealth system that enables the participant     to monitor their body weight, blood glucose values and blood pressure values, associated with     remote educational support and feedback to the general practitioner, can improve metabolic     control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM),     as compared to usual practice.   "
83380|NCT02194595|"     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive     deterioration in the function of the pancreatic beta-cells, which are the cells that produce     and secrete insulin (the hormone primarily responsible for the handling of glucose in the     body). The investigators propose a randomized controlled trial to determine whether combining     basal insulin with a new medication called exenatide is a therapeutic strategy that can     preserve beta-cell function early in the course of type 2 diabetes.   "
83381|NCT02194582|"     The investigators are trying to learn more about the cause of kidney diseases such as Focal     Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The     investigators are interested in discovering which genes play a role in causing a     predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in     families. Participation in our study involves a saliva sample and a urine sample that you can     give from home. There is no cost to participate. All information is kept private and     confidential. The investigators also like to include healthy volunteers (parents, spouses) if     interested/available but of course this is completely optional.   "
83382|NCT02194569|"     Rationale:      A higher citrate dose during continuous venovenous hemofiltration provides better     anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic     limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a     negative magnesium balance is unwanted.      Objective:      Aim of this study is to determine the magnesium balance of citrate-based continuous     veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium     balance depends on citrate dose.      Study design and methods:      A prospective randomized study conducted in critically ill patients with acute kidney injury     (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter)     or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a     postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL     (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in     the patient are tested for the following variables:      (0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca     (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and     creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the     time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24     hrs or at protocol exit.      Sample sites: arterial line, postfilter port (after postdilution and calcium compensation),     effluent sample. All flow rates to be noted.      Study population:      Twenty patients admitted to intensive care, requiring continuous renal replacement therapy     (CRRT) for AKI.      Intervention:      Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat     (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both     regimens are within standard protocolled CVVH treatment in the intensive care department.   "
83383|NCT02194556|"     This randomised, controlled, open-label, prospective trial is designed to assess the efficacy     and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus     Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer     patients with EGFR mutation.   "
83384|NCT02194543|"     To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract     surgery   "
83398|NCT02194361|"     Study to determine the Efficacy of Standardised Bilberry Extract in improving the night     vision and to evaluate its tolerability and safety.   "
83399|NCT02194348|"     The objective of the present study was to obtain information about safety, tolerability and     pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses     in healthy male and female volunteers   "
85531|NCT02166502|"     The purpose of this study is to determine whether the current dose of nevirapine recommended     in the Ontario Ministry of Health vertical transmission prevention protocol achieves     therapeutic drug levels in newborn infants at high risk of HIV infection.   "
83385|NCT02194530|"     This pilot study is collaboration between the Weill Cornell Medical College, Department of     Genetic Medicine and Yale University and will examine the pathways involved in allergic     response, primarily in food allergy; specifically peanut allergy.We will also study     non-allergic donors as well as patients with atopic disorders, primarily as control     subjects.We believe that this study will lead to discovery of significant pathways involved     in the allergic pathway that can be explored in more detail during follow-up studies in order     to address mechanistic questions that cannot be answered in a pilot trial. We believe that     such a pilot study represents the ideal approach to identify effective therapeutic     interventions and to simultaneously better understand the underlying mechanistic properties     involved in the allergy cascade. We think that this study forms the basis for a novel avenue     of research into the pathogenesis of allergic pathways, a disease that is still associated     with significant morbidity and mortality.   "
83386|NCT02194517|"     ELKa system is an advanced toolset which helps performing calculation of carbohydrate (CHO)     and fat/protein (FP) exchanges. It consists of ELKa software including database of various     meals and nutrients and ELKaPlus digital kitchen scale transmitting weight of products in a     real-time to a computer via universal serial bus (USB) port. After choosing the name of     particular product from the list, the program gives precise information about the amount of     CHO and FP exchanges in serving.      The aim of the study is to investigate the benefit of using ELKa toolset in comparison with     standard method of CHO and FP counting on metabolic control in type 1 diabetic children.   "
83387|NCT02194504|"     In the Belly Fat study, the effects of two different caloric-restricted diets on metabolic     health will be examined in male and female subjects with increased abdominal adiposity (BMI     >27 kg/m2). Metabolic health is defined as health of the primary metabolic organs the liver,     gut and the adipose tissue, examined in a static state as well as after the application of a     challenge test.      The diets are equally caloric-restricted, but differ in nutrient composition. It is     hypothesized that one of the two diets causes a larger improvement in organ health and     reduction in liver fat.   "
83388|NCT02194491|"     The purpose of this study is to evaluate a novel PET tracer ([11C]AS2471907), and to use     [11C]AS2471907 to assess the level and time-course of enzyme occupancy in the human brain     prior to and following single oral dose administration of ASP3662.   "
83389|NCT02194478|"     This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week     mind-body/meditation intervention on self-reported quality of life in individuals employed by     Allina Health. Outcomes will include validated questionnaires for depressive symptomology,     perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes     of salivary cortisol for a sub-sample of employees.   "
83390|NCT02194465|"     The main purpose of this study is to evaluate the safety and effectiveness of the study drug     known as LY2623091 in participants with high blood pressure.   "
83466|NCT02193477|"     The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint     Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in     patients undergoing radical surgery for gastric cancer   "
83392|NCT02194439|"     This study is designed to collect longitudinal biological samples from patients after     hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers     to validate biomarkers of both acute and chronic GVHD as well as for use in future     unspecified research. The centers include Dana-Farber Cancer Institute and Boston's     Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson     Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and     Indiana University Simon Cancer Center.   "
83393|NCT02194426|"     This research study is looking at a new DARPin based medication, called MP0250. There is     evidence from preclinical studies that MP0250 may be effective in the treatment of cancer.     This is the first study of MP0250 in humans and its main purpose is to test its safety and     tolerability in patients with cancer. This study will also examine how the drug is changed by     and removed from the body and look for indicators that the drug may be effective against     cancer. This study will test several different dose levels of the study drug to determine the     safety and tolerability profile of the drug.   "
83394|NCT02194413|"     This randomized pilot clinical trial studies healing touch or usual care in improving quality     of life in patients undergoing stem cell transplant. Healing touch may improve the quality of     life of patients undergoing stem cell transplant.   "
83395|NCT02194400|"     A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous     infusions of RSLV-132 in subjects with inactive to mild SLE.   "
83396|NCT02194387|"     Objectives:      Pilot 1 Primary aim: To explore the feasibility of using the Multi-phase Optimization     Strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD     Anderson employees. To address this aim, investigators will record and assess study and     intervention implementation, participant adherence to intervention component requirements,     and satisfaction with intervention approach and specific intervention components. Feasibility     of individual components and the overall intervention will be determined as described in the     protocol.      Pilot 2 Primary aim: To explore the feasibility of using the MOST approach to optimize energy     balance interventions in a sample of BRCA (BReast CAncer) positive and Lynch Syndrome     positive individuals and their family members. To address this aim, investigators will record     and assess study and intervention implementation, participant adherence to intervention     component requirements, and satisfaction with intervention approach and specific intervention     components. Feasibility of individual components and the overall intervention will be     determined as described in the protocol.      Pilot 3 Primary aim: To explore the feasibility of using the MOST approach to optimize energy     balance interventions in a sample of CLL (Chronic Lymphocytic Leukemia) patients. To address     this aim, investigators will record and assess study and intervention implementation,     participant adherence to intervention component requirements, and satisfaction with     intervention approach and specific intervention components. Feasibility of individual     components and the overall intervention will be determined as described in the protocol.   "
83480|NCT02193295|"     The purpose of this study is to examine whether weight reduction decreases intramyocellular     (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue     in people who are insulin resistant and have a family history of type 2 diabetes.   "
83400|NCT02194335|"     The objective of the present study was to obtain information about safety, tolerability and     pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy     male and female volunteers. With respect to pharmacokinetics, it was of particular importance     to investigate whether therapeutic plasma levels (for treatment of migraine) could have been     achieved by oral administration of a BIBN 4096 BS formulation.   "
83401|NCT02194322|"     The objective of the present study is to obtain information about the safety, tolerability     and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing     doses in healthy male and female volunteers   "
83402|NCT02194309|"     To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine     following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5     mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg     amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days   "
83403|NCT02194296|"     Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge     compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation   "
83404|NCT02194283|"     The main objectives of the present study are to determine pharmacokinetics of ambroxol in     healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for     four days   "
83405|NCT02194270|"     Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15     mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol     hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state   "
83406|NCT02194257|"     Study to determine the basic pharmacokinetics of ambroxol and [14C]-radioactivity including     mass balance, excretion pathways and complete metabolism in healthy male volunteers following     administration of a lozenge of 20 mg ambroxol together with an oral solution of 0.4 mg     [14C]-ambroxol labelled in two different positions   "
83407|NCT02194244|"     This study will compare the pharmacokinetic performance of film-coated tablet and granule     formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized,     four-period, four-treatment crossover design is used. In each period, each volunteer will     receive a single oral dose of the tablet or granule formulation either with or without food.   "
83408|NCT02194231|"     The purpose of this study is to determine whether trabectedin is effective in the treatment     of malignant pleural mesothelioma (MPM).   "
83409|NCT02194218|"     Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as     4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence     of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single     dose   "
83410|NCT02194205|"     To compare the long-term (one-year) bronchodilator efficacy and safety of COMBIVENT     hydrofluoroalkane (HFA) Inhalation Aerosol to COMBIVENT chlorofluorocarbon (CFC) Inhalation     Aerosol and Placebo formulations of each in patients with COPD. In addition, steady state     pharmacokinetics over one dosing interval following four weeks of therapy will be     characterized.   "
83411|NCT02194192|"     Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a     very common problem leading to several complications to both patients and their babies. It     can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important     complication is the decreasing blood flow to babies; which may lead to fetal acidosis.      Many interventions has been studied in order to prevent hypotension after spinal anesthesia     in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine,     phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic     drug) can be effectively used to prevent hypotension after spinal anesthesia in normal     patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish     reflex.      This aim of this study is to compare the efficacy of ephedrine and ondansetron in the     prevention of maternal hypotension after spinal anesthesia in cesarean section.   "
83412|NCT02194179|"     The objective was to establish the pharmacokinetic (PK) profile at steady state of two     different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily (QD)     under fasted and fed conditions in comparison with the commercially available NVP immediate     release (IR) tablet at 200 mg BID (400 mg/day).   "
83413|NCT02194166|"     This multicenter study in participants with HER2-positive eBC will investigate participants'     pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use     injection device (SID) or via vial for manual administration using a hand-held syringe (SC     vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles     of intravenous [IV] and 14 cycles of SC trastuzumab).   "
83414|NCT02194153|"     Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of     treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse®     in a real life setting outside clinical trials.   "
83415|NCT02194140|"     Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's     localization by oral administration of iodinated contrast material.   "
83416|NCT02194127|"     Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision     and to test its tolerability and safety.   "
83417|NCT02194114|"     The primary purpose of this study is to assess dietary protein requirements in clinically     stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary     protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a     safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.   "
83418|NCT02194101|"     This is an observational pilot study of supernormal oxygen delivery goal for patients with     proximal femoral fracture.   "
83430|NCT02193945|"     The purpose of this study is to retrospectively review and further characterize anatomic and     symptomatic changes over six months immediately following treatment of symptomatic     vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset     and resolution of anatomy and symptoms.   "
83419|NCT02194088|"     This research study is being done to assess if a combination of medications can enhance the     relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The     investigators also want to find out if certain genes may be linked to individual differences     in experienced efficacy of pain killers. The combination of medications under investigation     is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug     Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain     types of poisoning, heartbeat problems, and other diseases but atropine is not approved to     treat pain. However, atropine has been used for many years in different European countries to     treat painful conditions such as stomach cramps.This research study will compare diclofenac     and atropine to placebo.   "
83420|NCT02194075|"     Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on     pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients     with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the     hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of     fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic     strategy to improve outcome in OCD.   "
83421|NCT02194062|"     The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal     saline rinses in both the upright and head forward positions in patients who have had     functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis     (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-     Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4     months, and 6 months post-op.   "
83422|NCT02194049|"     This phase I trial studies the side effects and the best dose of PI3K inhibitor BKM120 when     given together with cisplatin and etoposide in treating patients with advanced solid tumors     or small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing , or by stopping them from spreading. PI3K inhibitor BKM120 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving PI3K     inhibitor BKM120 with cisplatin and etoposide may kill more tumor cells.   "
83423|NCT02194036|"     Outpatients that suffer from different anxiety disorders may have physical ailments that     negatively affect daily life functioning and quality of life. LOF is a physical therapy     approach focusing on the link between bodily and mental balance and through defined, but     simple movements, patients are expected to learn how to cope and reduce health complaints.      This study aims to investigate the short- and longterm effect of LOF compared to other     standardized psychiatric treatments given in the clinic on levels of anxiety and depression,     health related function and quality of life.   "
83424|NCT02194023|"     In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC)     mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield     similar or better clinical results regarding the inhibition of de novo plaque growth compared     to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without     alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula     and 3) that these mouthrinses have no negative microbiological effects, and they control     total bacterial loads.   "
83426|NCT02193997|"     This study examines the effects of dietary fiber in the treatment of functional childhood     constipation.   "
83427|NCT02193984|"     Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family     Physicians Foundation. The study was designed to help patients better manage their diabetes,     and was a partnership between the Institute for Behavioral and Community Health and Clínicas     de Salud del Pueblo, Inc (CDSDP), a private, non-profit corporation providing comprehensive     primary care services to residents throughout Imperial and Riverside Counties, California.     The investigators identified 336 patients with uncontrolled diabetes from three CDSDP     clinics. Patients were randomly assigned to intervention or control conditions. The 12-month     intervention consisted of individual diabetes management support delivered by a trained     volunteer peer supporter. The primary aim was determine if peer support can help patients     better manage their diabetes and improve the quality of their lives. Intervention     effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and     12 months. This study was part of the global Peers for Progress network which has been     testing peer support programs in 13 countries.   "
83428|NCT02193971|"     -  Study objectives             1. To compare the safety and long-term efficacy of coronary stenting with biostable               polymer everolimus-eluting coronary stent system (Promus PremierTM) with               biodegradable polymer biolimus-eluting coronary stent system (Biomatrix®, Biomatrix               Flex® and Nobori®) in patients with acute coronary syndrome             2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared               with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome               undergoing percutaneous coronary intervention        -  Study design :      Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the     following in CHD patients        1. Non-inferiority of biostable polymer everolimus-eluting stent (Promus PremierTM)          compared with biodegradable polymer biolimus-eluting coronary stent system          (Biomatrix®,Biomatrix Flex® and Nobori®) in terms of patient-oriented composite outcome        2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of          major adverse cardiovascular events   "
83429|NCT02193958|"     A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory     Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts     will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML     treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.   "
83431|NCT02193932|"     A prospective exploratory study in patients with drug resistant epilepsy with a target     comparison of long term outcome. NeuroScan software modules and a MagLink will be used to     acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining     integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the     MRI machine, without compromising the raw EEG data.   "
83432|NCT02193919|"     Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments     may help even more. Determining if a high protein diet vs a low protein diet results in     improving psoriais may help lead to future dietary effects on psoriasis therapy   "
83433|NCT02193906|"     The purpose of the study is to determine the effect of an web-based intensive cognitive     rehabilitation program in neuropsychological performance of a population of patients with     multiple sclerosis or clinical isolated syndrome.   "
83434|NCT02193893|"     The purpose of this study is to test the safety and effectiveness of an autologous bone     marrow-derived stem/progenitor cells infusion in the subjects with diagnosed amyotrophic     lateral sclerosis.   "
83435|NCT02193880|"     The purpose of this study is to determine the safety and efficacy of post-transplant     cyclophosphamide and a post-transplant infusion of donor cells, that have been specially     processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic     stem cell transplant to help reduce the risk of relapse without increasing the risk of     graft-versus-host disease.   "
83436|NCT02193867|"     This is an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly     progressive LAL Deficiency. Eligible subjects will receive once-weekly infusions of     sebelipase alfa for up to 3 years.   "
83437|NCT02193854|"     Objective This study is aimed to estimate the distance, time and the cost of travel saved by     patients who are seeking tele-dermatology (TD) service though smart mobile phones in the     resource poor settings at the rural clinics of Mongolia.      Methods A cluster-randomised trial was conducted for six months at the 20 rural health     clinics selected from three districts in Mongolia. With a computer-generated sequence, health     clinics were randomly allocated either to the intervention group, in which all general     practitioners (GPs) received TD consultation through Sana system, or the control group, in     which GPs referred patients to the dermatologist at district hospital whenever needed. The     primary outcome was to estimate the distance traveled, times spend and the cost of travel     required in receiving dermal care for patients in rural Mongolia. Analysis was done to     estimate the difference between the aforementioned parameters among intervention and control     groups.   "
83438|NCT02193841|"     Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long     bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one     is better than another. The purpose of this research trial is to compare the effectiveness of     two common treatments that are used by surgeons today.   "
83439|NCT02193828|"     The objectives of this study are to assess the safety and effectiveness of AA4500 in treating     palmar Dupuytren's disease nodules.   "
83440|NCT02193815|"     This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the     effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects     with psoriasis vulgaris.   "
83441|NCT02193802|"     The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been     demonstrated in a number of studies.      Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of     small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not     complete since it does not allow exploration of the small bowel beyond the terminal ileum     (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.   "
83467|NCT02193464|"     The purpose of this study is to investigate the incidence and natural course of inflammatory     bowel disease in the southeastern area of Korea.   "
83468|NCT02193451|"     Some men develop difficulty passing urine (voiding) as they age. This may be because an     enlarged prostate gland (which sits round the base of the bladder) narrows the bladder outlet     (urethra) or because the bladder becomes less able to contract. Prostate surgery is more     likely to help symptoms in the first group, while the second group may have no improvement     after surgery, while being exposed to risk of complications of surgery.      Invasive urodynamics involves putting a tube (catheter) into the bladder via the penis, and     another into the rectum, to measure bladder and abdominal pressures while the bladder is     filled with a sterile fluid. Invasive urodynamics can measure bladder pressures during     filling and voiding, and bladder outlet obstruction pressures. The procedure is considered     safe, but some men find it uncomfortable or undignified, and a few develop urine infection     afterwards. We think that it could be useful to select the men who should and should not have     surgery. However, no studies have been conducted so far to tell us if this is true: UPSTREAM     is designed to find out if the invasive tests are worthwhile.      UPSTREAM is a randomised controlled trial in men who have bothersome difficulty passing urine     and who are considering having surgery for the symptoms. The group studied will be men who     continue to be bothered by difficulty passing urine, despite initial treatment such as drugs,     where symptoms are thought to be due to bladder outlet obstruction. The men will be assigned     at random to either invasive urodynamic tests as well as the standard tests (Invasive     urodynamics) or to the routine standard tests (Usual care control arm) alone. Routine     standard tests include asking men to complete a questionnaire (the International Prostate     Symptom Score (IPSS)) and a bladder diary, carrying out flow rate testing, and checking the     urine for infection. Some surgeons also use discretionary tests such as the PSA     cancer-screening blood test.      The following men will be invited to participate (inclusion criterion);      • Men considering undergoing surgery as a treatment option for bothersome urinary symptoms      Men will not be invited to participate (exclusion criteria) if they:        -  are unable to pass urine without a catheter (urinary retention)        -  have a relevant neurological disease, such as a stroke        -  are undergoing treatment for prostate or bladder cancer        -  have previously had prostate surgery        -  are not medically fit for surgery, or are unable to complete outcome assessments        -  do not consent to be assigned at random to one of the pathways We will compare the two          methods of investigation by finding out whether the men had similar relief of their          symptoms, by measuring the change in the prostate symptom score (IPSS) in the two groups          at 18 months after randomisation.      We will also look at the following secondary outcomes:        -  Whether the invasive tests changed the decision for surgery in some of the men (how many          men had surgery in each of the two groups?)        -  The cost-effectiveness of the two management pathways        -  Adverse effects of (a) the tests and (b) the treatments at 6, 12 & 18 months (e.g.          urinary infection, urinary retention)        -  Urinary symptoms at 6, 12 & 18 months, using the International Consultation on          Incontinence Questionnaires (ICIQ) and the Male Lower Urinary Tract Symptoms          questionnaire (ICIQ-MLUTS)        -  Quality of life, using the ICIQ-QoL questionnaire        -  Sexual function, using the ICIQ-MLUTS sex questionnaire        -  Satisfaction with urodynamic testing, using the ICIQ-UDS-S questionnaire        -  The maximum urinary flow rate (Qmax) at 18 months        -  Health outcomes, using the EQ-5D-5L questionnaire   "
83442|NCT02193789|"     In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis     site stricture is very severe complication. It can improve by temporary through the scope     covered metallic stent. It is very effective procedure about the stricture. But stent     migration is very severe complication. Herein the investigators suggest newly method to     prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent     stent migration. But it is difficult to remove stent after resolved stricture. So the     investigators add the suture between hemoclip and stent. And the investigators cut the suture     when stent removal.   "
83443|NCT02193776|"     The purpose of this study is to determine the mycobactericidal activity of combinations of     bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks     of treatment.   "
83444|NCT02193763|"     This is a prospective, randomized study evaluating the efficacy of bedside ultrasound     assisted lumbar puncture in pediatric patients   "
83445|NCT02193750|"     The investigators hypothesize that a novel method for oligosaccharide supplementation, in the     form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS),     will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD)     in remission.   "
83446|NCT02193737|"     National guidelines about post-operative fasting after general anesthesia are missing.      Current clinical practices are highly variable and no study has ever evaluated on a large     scale the real risk of an early drinks recovery in postoperative period.      The aim of this study is to state the impact of early drinks recovery after general     anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.   "
83447|NCT02193724|"     The goal of this study is to determine if human RB1-deficient induced pluripotent stem cells     (iPSCs) can produce retina, and, furthermore, can give rise to retinoblastoma in culture.     This unique opportunity to study the initiation of retinoblastoma in the developing retina     will shed light on the cell of origin for retinoblastoma and allow the investigators to study     the earliest molecular and cellular events in retinoblastoma tumorigenesis.      OBJECTIVES:        -  To establish the feasibility of producing induced pluripotent stem cells (iPSCs) from          retinoblastoma patients with germline RB1 mutations (RB1-deficient iPSCs).        -  To validate human RB1-deficient iPSCs by confirming karyotype, pluripotency and RB1          mutation.        -  To differentiate the RB1-deficient iPSCs into retina as a model of the initiation of          retinoblastoma in the developing retina.   "
84244|NCT02183584|"     Investigation of the bioavailability of linagliptin after concomitant multiple oral     administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison     to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)   "
83448|NCT02193711|"     The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy     of a topical cream compared to a placebo cream. The study population will be those with mild     to moderate osteoarthritis of the knee.      The trial will also provide information about potential side effects and verify the safety of     this composition. Blood levels will be done to assess inflammation and to determine whether     any systemic absorption has occurred.      Hypothesis/Purpose        -  Pain scores after active treatment will be significantly reduced in comparison to          placebo.        -  There will be an improvement in stiffness and physical function as measured by the WOMAC          using the active cream as compared to placebo.        -  There will be a decrease in the level of inflammation assessed at baseline, end of week          3 and end of week 6.        -  The blood concentration of the active ingredient in the topical cream will not exceed          the maximum daily dose that will be consumed by participants.   "
83449|NCT02193698|"     This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent     or refractory POEMS (Crow-Fukase) syndrome.   "
83450|NCT02193685|"     To identify demographic, clinical, genetic, immunologic and/or microbial (i.e., fecal stream     characterization) risk factors that influence the likelihood of development of the HAEC     phenotype in children who carry the diagnosis of HD. The newly formed HAEC Collaborative     Research Group (HCRG) will utilize the 4 participating centers in the current consortia and     recruit additional centers to enroll children diagnosed with Hirschsprung disease.      1a: To recruit 200 patients with Hirschsprung disease without HAEC.      1b: To recruit 200 patients with Hirschsprung disease and HAEC using standardized diagnostic     criteria by collaborating with participating members of the HAEC Collaborative Research     Group[1].      1c: To collect clinical and demographic information from well-characterized HD patients both     with and without HAEC.      1d: To collect samples blood for DNA for genome wide association study (GWAS) by high     throughput SNP technology and mutational analysis of known HSCR genes.      1e: To collect serum samples at the time of recruitment in a subset cohort (n=50 HD only,     n=50 HD + HAEC) for serological immune markers known for inflammatory bowel disease (IBD)     including ANCA, ASCA, OMPC, I2, and CBir1 and any newly identified markers.      1f: To collect and store fresh fecal specimens for future evaluation by molecular     methodologies to determine relative proportions of enteric microflora in a subset cohort     (n=50 HD only, n=50 HD + HAEC) of children (<18 years).      1g: To establish a Centralized Data Coordinating Center for data collection, data quality and     detailed data analyses (CSMC) and tissue bank (CSMC) to facilitate specimen analysis for this     study.      The HAEC risk factor identification will be completed by multivariate logistic regression     analysis. Genetic association will be studied for each SNP in the GWAS together with all     other potential risk factors. Further analysis will be carried out to evaluate multiple     SNPs/genes simultaneously.   "
83451|NCT02193672|"     The goal of this clinical research study is to find out if using the tracer (liquid used in     imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography     (PET/CT) scans will help researchers learn more quickly if the disease is responding to     treatment.   "
83452|NCT02193659|"     The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who     had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance.     The main objective is to assess the effect of breakfast cereals intake with omega-3 on women     lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the     small dyslipidemia.   "
83453|NCT02193646|"     The investigators are retrospectively comparing detection rates of adenomatous polyps,     advanced adenomas, and size assessment of the polyps among Rush University Medical Center     endoscopists. The investigators plan to review whether the size assessment of adenomatous     polyps affected the surveillance protocols and if the location of polyps detected affected     the detection rates.   "
83491|NCT02193152|"     The purpose of this study is to evaluate how participants with advanced non-small cell lung     cancer (NSCLC) that have certain abnormalities in the pazopanib target genes respond to     pazopanib treatment.   "
83492|NCT02193139|"     This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing     medication and identify the dose or doses that may effectively reduce axillary sweating in     hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.   "
83454|NCT02193633|"     This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel     anticancer agent, in combination with paclitaxel.      AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on,     4 days off with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment     break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will     be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so.     Once we have determined the maximum tolerated dose (MTD) using the 3 days on, 4 days off     schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days with their paclitaxel     infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses of     AZD2014 to determine the MTD for the 2 days on, 5 days off schedule.      On completion of the dose escalation phase of the study patients with ovarian cancer and     squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A     minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to     the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients will     be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of the     combination of AZD2014 and paclitaxel.   "
83455|NCT02193620|"     The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral     Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.   "
83456|NCT02193607|"     1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure,          when added to a planned improved reconstruction pelvic surgery, improves the rate of          urinary stress continence in subjects with occult stress incontinence.        2. Observe the immediate and short-term complications, overall urinary tract function, and          other aspects of pelvic health between subjects with and without a TVT-O procedure.   "
83457|NCT02193594|"     Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of     gastroesophageal junction and upper gastric cancers in the decade.According to some     researches,CRT had shown its good curative effects in local control and prolonged overall     survival.However,the optimization scheme for CRT and its influence to surgery remains     controversial.Meanwhile,there were many design flaws in the past few research,such as the     lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry     out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety     of CRT.   "
83458|NCT02193581|"     The use of MDS to access the presence of melanoma in the skin.   "
83473|NCT02193386|"     The study aims to evaluate evidence-based practice behavior in usual care physical therapy in     Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy     program based on evidence-based guidelines to the effects of a period of usual care. It is     hypothesized that supporting therapists by providing a predefined evidence-based intervention     program, will result in an improved treatment outcome compared to the usual care physical     therapy.   "
83474|NCT02193373|"     The purpose this study is to determine which manual medicine technique or combination of     techniques has the greatest effect on the natural changes in heart rate.   "
83459|NCT02193568|"     This randomized clinical trial studies light sedation compared with intubated general     anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep     sleep) in reducing complications and length of hospital stay in patients with brain cancer     undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so     doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to     remain awake during their surgery, while intubated general anesthesia puts patients to sleep.     Surgery complication rates may be reduced if intubated general anesthesia is avoided.     Additionally, patients not receiving intubated general anesthesia tend to recover more     quickly after surgery. It is not yet known whether light sedation is better at reducing     complications and length of hospital stay compared to intubated general anesthesia.   "
83460|NCT02193555|"     The aim of this study is to assess the visual performance of prototype soft contact lens     designs compared to a commercially available contact lens   "
83461|NCT02193542|"     Anesthesiologists commonly administer pain relief during labor or providing anesthesia for     cesarean delivery. Two main methods are used to achieve these goal: Regional anesthesia     where the mother is given medication through a needle or catheter in her back and the mother     is kept awake, or General anesthesia, where the mother is given intravenous medication and     is kept asleep.      Regional anesthesia uses a needle to enter a narrow space in the mother's back where     medications can be given. In some patients, it takes longer to find this target space in the     back. In emergency situation, however, there is often little time to find this space, and the     backup method would be the general anesthesia technique.      If general anesthesia is required, a breathing tube needs to be inserted to help support the     mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing     this in advanced helps anesthesiologists create a safe plan for the patients. A lot of     research has been done to determine factors that would predict which patients would need more     time and preparation for general anesthesia and regional anesthesia.      The purpose of this study is to study how common it is for the pregnant patients who have a     difficult regional and general anesthesia.   "
83462|NCT02193529|"     Weight reducing surgery is the only effective therapy for morbid obese patients.      Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There     is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was     to investigate the relationship between dietary intake and weight loss after LSG.   "
83463|NCT02193516|"     Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can     indicate possible nephropathy. The evolution of CMD across gestation had not been well     established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20     weeks. In our study we would like to determine the exact timing of it's sonographic     visualisation. This is a prospective study recruiting women between 14-24 week gestation     during routine ultrasound screening. A midsagittal image of each kidney will be taken by a     single sonographer and examined for the presence of the CMD by two other sonographers blinded     to gestational age.   "
83924|NCT02187497|"     The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives     was evaluated. The results of the present study are to be used in the Japanese population     pharmacokinetics analysis   "
83469|NCT02193438|"     Human studies have shown that capsaicin, a compound extracted from chilly peppers, can     stimulate certain physiologic functions (for example, energy expenditure, thermogenesis,     lipid oxidation, heart rate, etc.).      The purpose of this study is to measure the impact of ingesting various spicy molecules on a     set of physiologic parameters compared to a placebo. The molecules were selected for their     different sensory properties.      The results of this study will allow us to implement an effective method for measuring the     impact of ingesting spices on certain body functions (for example, metabolism and autonomic     nervous system activity). This study will also allow us to identify the beneficial properties     of eating certain spices.   "
83470|NCT02193425|"     Background:      - Magnetic resonance imaging (MRI) is used to investigate brain function. Researchers want to     use MRI to better understand the function patterns and connections between brain regions in     healthy people. This might help people with brain diseases in the future.      Objectives:        -  To evaluate MRI methods performed twice on the same day.        -  To evaluate brain function using positron emission tomography (PET).      Eligibility:      - Healthy volunteers at least 18 years old.      Design:        -  Visit 1:        -  Participants will be screened with medical history, physical exam, and interview about          drug and alcohol use and psychiatric history.        -  They will give blood and urine samples. Their breath will be tested for alcohol and          smoking.        -  Visit 2:        -  Participants will have urine collected. They will have MRI scans, some while resting,          some while doing tasks on a computer.        -  The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on          a table that slides in and out of the cylinder, with a coil over their head.          Participants will get earplugs for loud noises.        -  Visit 3:        -  Participants will have urine collected.        -  A needle will guide a thin plastic tube (catheter) into each arm. The needle will be          removed, leaving the catheter in the vein.        -  Participants will then have a PET scan. They will get the chemical 18FDG in the          catheter. They will lie on a bed that slides in and out of the PET scanner, with a cap          on their head.        -  Participants may have tests of memory, attention, concentration, and thinking. They may          complete interviews, questionnaires, tests on paper or computer, and simple actions.        -  Participants will wear a device for 1 week between visits to measure activity and sleep.   "
83471|NCT02193412|"     The purpose of this study is to determine whether the value of analgesia nociception index     (ANI) is influenced by variations of systemic venous return (cardiac preload) under general     anaesthesia.   "
83472|NCT02193399|"     Research project with patients undergoing allogeneic hematopoietic transplantation in the     hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main     objective is to assess the differences in skeletal muscle and functional variables in the     experimental group underwent a physiotherapy treatment that takes place during the pre-and     post-transplant period, compared to a control group.   "
83475|NCT02193360|"     The purpose of this study is to determine the initial safety, tolerability and     pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC   "
83482|NCT02193269|"     To determine minocycline's effects on cognitive performance and measures of mood in abstinent     cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits     microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric     oxide (NO) production. Previous animal and human studies suggest that minocycline may have     utility as a treatment for cocaine addiction.   "
83483|NCT02193256|"     The purpose of this study is to examine the effect of varenicline and prazosin on smoking,     drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an     FDA approved smoking cessation medication. Some smokers report sleep problems when taking     varenicline. This study will test whether using prazosin, which is an FDA-approved blood     pressure medication, in combination with varenicline reduces sleep problems that can be     associated with using varenicline for smoking cessation. In addition, the study will examine     the combined effects of these medications on smoking and drinking.      Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia     symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt.      Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia     symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.   "
83484|NCT02193243|"     The six-minute walk test is an established submaximal exercise test. Its role in examination     of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective of     this study was a comparison of the 6MWT with other established parameters of functional     capacity, in grown-up patients with GUCH.   "
83485|NCT02193230|"     Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.      The treatment consists in making daily local treatment with topical steroid on inflammatory     lesions and emollient on the whole body. However, approximately 70% of patients do not adhere     to therapy.      Studies have shown that this treatment failure is caused by the complexity of the treatment,     the time required for its implementation, the cost of treatment, the dosage of the products,     fear of side effects or misunderstanding about the chronicity of these diseases inflammatory     conditions of the skin.      This study aims to evaluate the consideration of patient preference in the choice of     excipient used for the topical treatment of eczema.   "
83486|NCT02193217|"     The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability     of MT-1303 in healthy subjects.   "
83487|NCT02193204|"     The purpose of this study is to examine potential stress and immune systems adaptations     underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and social     drinkers (SDs) with and without high levels of depressive symptomatology (+dep / - dep).     Using the investigators experimentally validated guided imagery procedure, the investigators     propose to examine the response of brain stress and immune systems to personalized guided     stressful imagery using subjective, physiological and neurobiological assessments in 60     healthy controls and 60 alcoholic dependent individuals with and without depressive     symptomatology.   "
83488|NCT02193191|"     The purpose of this research study is to test the safety and efficacy of a drug called     Plerixafor. Plerixafor is approved by the US FDA for use in increasing blood stem cell counts     before collection in cancer patients. It is not yet approved for patients with sickle cell     disease. The investigators want to find out if Plerixafor can be used to increase cell counts     in patients with sickle cell disease.   "
83489|NCT02193178|"     The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better     than the participants' habitual contact lenses. Further, that a minimum of 80% of those     enrolled will complete 2 weeks of lens wear with no contraindication to continue.   "
83490|NCT02193165|"     The objective of this clinical research study is to assess the efficacy of three oral hygiene     multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a     mouthwash in controlling established dental plaque and gingivitis.   "
83493|NCT02193126|"     The Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois     Department of Children and Family Services (DCFS) is implementing a trauma-focused     intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase     permanency rates for a target population of children identified as being most at risk of     long-term foster care.   "
83494|NCT02193113|"     This is a Phase 1 study to investigate the safety, tolerability of the novel plasma     kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first     step to investigate the hypothesis that plasma kallikrein plays an important role in the     disease process behind diabetic macular edema in many patients   "
83495|NCT02193100|"     To characterize the metabolism of glucose by the leukemic cells in patients with leukemia     before and after initial chemotherapy.      To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells     in leukemic patients.   "
83496|NCT02193087|"     The purpose of this study is to evaluate the equivalence of the lyophilized formulation of     Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of     TDV.   "
83497|NCT02193074|"     The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS     396443) administered intrathecally (IT) to participants with infantile-onset with     infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to     examine the safety and tolerability of nusinersen administered intrathecally to participants     with infantile-onset SMA.   "
83517|NCT02192814|"     EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of     intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will     be administered for 5 days as replacement for oral LCM tablets in Japanese adults with     partial-onset seizures.   "
84245|NCT02183571|"     Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in     the strengths of 1000 mg (part I) and 500 mg (part II)   "
83498|NCT02193061|"     Assess the immunological behavior of children from 2 months of age that receive one out of     seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 -     Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq)     versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine),     Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group     5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one     dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of     pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of     pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.      Secondary objectives        -  To describe number and features of acute diarrheal disease (ADD) due to rotavirus          displayed in the seven prevention schedules.        -  To describe the adverse events temporarily associated with the seven prevention          schedules.      Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus     antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages     and the GMTs induced in subjects that received the routine vaccination schedules with two     doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).   "
83499|NCT02193048|"     The purpose of this study is to prospectively evaluate a scoring system to predict a mild     course of disease in patients newly diagnosed with Crohn's disease.   "
83500|NCT02193035|"     Microparticles are small cell fragments that can induce fat plaques, calcification and     formation of thrombus. They can be released through multiple stimulations, but also the high     flow of blood through partially obstructed aortic valves.      In patients with severely obstructed aortic valves the investigators hypothesize that     microparticles levels will be elevated and that they will go down after percutaneous     treatment of the valves.   "
83501|NCT02193022|"     Hypothesis:      Primary hypothesis:        1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on          body weight and height) for 12 weeks is safe with a cure rate of ≥95%.           Secondary hypothesis:        2. Development of PKDL in children and adolescent is genetically predisposed and is          associated with IL-10 & IFN-gamma gene polymorphism causing high and low serum level of          IL-10 and IFN-gamma respectively.        3. Nutritional & environmental factors such as low serum vitamin E, A, D, Zn & arsenic          exposure are associated with PKDL.   "
83502|NCT02193009|"     The primary aim of this pragmatic randomized-controlled trial was to determine the     effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption     (SIPsmartER) when compared to a matched contact physical activity promotion control group     (MoveMore).   "
83503|NCT02192996|"     This pilot trial is designed to investigate the benefits of the use of probiotics in GUT     microbiota development and/or immunological biomarkers and how this can be related with the     clinical status of very low birth weight preterms during their first weeks of life at the     neonatal intensive care unit(NICU).   "
83504|NCT02192983|"     This study is designed to assess what is the better neoadjuvant chemotherapy regimen for     patients with initially unresectable locally advanced gastric cancer.   "
83505|NCT02192970|"     The investigators hypothesize that bevacizumab instilled into the vitreous after primary     retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and     subsequent retinal re-detachment.   "
83511|NCT02192892|"     Addition of α-amylase is considered as one of most effective solution to improve energy     density of cereal based porridges (WHO, 2008). By adding α-amylase, the viscosity of     porridges will be decreased while keeping dry matter content constant. Potential positive     impact is to significantly improve efficiency of WFP nutritional programmes targeting     vulnerable groups suffering from acute malnutrition.      The acceptance of porridges made with α-amylase is tested compared to porridges made without     α-amylase among 12-36 months old children and their caregivers. Acceptance is measured based     on energy intake. The porridges tested consist of fortified blended Supercereal (12- <24     months) and Supercereal-Plus (24-36 months) based on Corn Soy Blend (CSB) extruded or drum     dried, Wheat Soy Blend (WSB), Rice Soy Blend (RSB), all with and without α-amylase, or a     commercial porridge, or eeZee bar.   "
83925|NCT02187484|"     The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were     evaluated in hypertensive patients with nephropathy   "
83506|NCT02192957|"     Atrial fibrillation is an abnormal heart rhythm in which the top chambers of the heart (the     atrial chambers) beat very fast. Electrical cardioversion is a technique to convert heart     rhythm from AF to normal rhythm. The technique sends out a brief electric shock to the heart     through electrodes (paddles or skin patches) applied to the outside of the chest wall. The     shock resets the heart rhythm back to its normal pattern.      This technique is practiced at many hospitals, including the Heart Institute, and is not     experimental. However no detailed national or international guidelines exist to assist     physicians in performing cardioversion. Physicians use a variety of methods. Electrical     cardioversion does not always restore normal rhythm. Adjusting the electrical energy dose,     changing the electrode position and applying pressure to the electrodes may improve the     success rate.      This study will look at the safety and efficacy of a protocol (step by step method) for     electrical cardioversion. The protocol prescribes the electrical energy dose, the electrode     position and the application of pressure to the electrodes the physician will use. The     individual elements of the protocol (energy dose, electrode position and pressure     application) are often used by physician in clinical practice but not necessarily in the step     by step order.      The purpose of this study is to get all doctors to follow a standard protocol 'the Ottawa AF     cardioversion protocol'. We think that using this protocol will improve overall cardioversion     success rates. The results of this study may change usual practice in Canada and in other     countries.      All supplies, equipment and medications used in the protocol cardioversion are approved by     Health Canada.      We estimate that 389 participants from the University of Ottawa Heart Institute will be     enrolled in the study over the next 2 years. The results will be compared with a group of     previous patients.   "
83507|NCT02192944|"     Chloroquine and piperaquine are the two most widely used antimalarial drugs ever. Hundreds of     millions of people have received these drugs. Both are structurally similar and have     cardiovascular effect. While there are no concerns over the use of chloroquine, regulatory     authorities have suggested restrictions on the use of piperaquine.      We have recently completed a series of cross-over clinical and pharmacokinetic evaluations of     chloroquine, piperaquine, pyronaridine and primaquine in healthy subjects. These studied were     approved by the ethical committee of FTM. All drugs were well tolerated with no clinically     significant ECG changes. Four subjects were in two studies. This offers a unique opportunity     to compare the electrocardiographic effects of chloroquine and piperaquine in the same     subjects and therefore characterize the concentration-effect relationships, and thus relative     safety.      We propose to extend the previous subject study to recruit 16 subjects including those who     have received either piperaquine or chloroquine in our previous studies so that 20 subjects     received both drugs for a crossover comparison. The blood sampling schedule and     electrocardiograms would be exactly the same as previously but would finish at 24 hours.   "
83515|NCT02192840|"     Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary     interventions (PCI) and are associated with higher rates of periprocedural complications as     well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal     approach to coronary bifurcations treatment is still a subject of debate, especially when the     side branch is large, not easily accessible and narrowed by a long lesion. One of the     proposed alternatives are dedicated bifurcation stents (DBS). However, there is large     scarcity of randomized trials with DBS.      The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two     intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any     regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting     of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®     (Balton, PL).   "
83508|NCT02192931|"     Methamphetamine (MA) addiction is a public health concern that causes substantial harm to     individual users, and imposes an economic burden in the U.S. totaling up to $48.3 billion     annually. This study proposes to address a critical aspect of this problem: the lack of any     proven, FDA-approved pharmacological treatments for MA users. The proposal combines an     intervention designed to improve energy metabolism in the brain, and a neuroimaging technique     capable of measuring the neurochemicals that represent cerebral bioenergetic function. The     study will replicate and extend a key neuroimaging finding from the investigators recent MA     studies: that MA users have decreased phosphocreatine (PCr) levels in the brain, compared to     healthy volunteers. Phosphocreatine is the substrate reservoir for the creatine kinase     reaction, which reversibly converts PCr into adenosine triphosphate (ATP), the brain's major     energy supply, and creatine. Neuronal energy demands are met through a shift in reaction     equilibrium, which is designed to maintain the concentration of ATP constant. Research     results from the investigators recent study also showed that female MA users have lower brain     PCr levels compared to male users. These findings join the converging lines of evidence that     MA use is associated with mitochondrial dysfunction, i.e. deficient energy metabolism, in the     brain. Frequently, MA users also experience depression, as well as cognitive deficits.     Interestingly, both of these entities are also linked to mitochondrial dysfunction in the     brain.      The long-term goal of this research program is to define the alterations in brain chemistry     that underlie MA use disorders, and to utilize translational magnetic resonance spectroscopy     (MRS) neuroimaging to identify rational brain-based treatment targets. Once a     hypothesis-driven intervention is identified, MRS can then be further employed in treatment     studies, to verify that target engagement is achieved. The specific aims of this proposal     are an example of this stepwise scientific process: the nutritional supplement creatine will     be tested in a randomized, placebo-controlled study of women with MA use disorders, to     investigate creatine's effect on cerebral PCr levels, depressive symptoms, and MA usage.   "
83509|NCT02192918|"     The goal of this research is to develop and test the feasibility of an intervention that     stimulates uptake of healthy alternatives to tanning by providing free access to them for a     limited time. Free access gives participants a low-risk opportunity to try something new that     is consistent with their motivations. Free access also allows them to experience the     reinforcing properties of the alternatives which could prime continued use after the free     trial period. The objective of the present study is to determine the feasibility and     short-term efficacy of providing free alternatives to indoor tanners in an effort to nudge     them to switch from indoor tanning to healthy alternatives.   "
83510|NCT02192905|"     The purpose of this research is to develop and test the feasibility of Habit, a weight loss     mobile application that is designed to coach patients through their weight loss challenges.     In a pilot randomized trial in 50 obese participants, we will test the feasibility of the     Smart Coach mobile application when paired with a shortened online-delivered (8-week)     behavioral weight loss intervention relative to a shortened behavioral weight intervention.     Feasibility outcomes include frequency and duration of usage of the mobile app and each     feature, recruitment, and retention. Post-intervention focus groups will discuss the     feasibility and acceptability of the intervention. The investigators will also do exploratory     analyses comparing conditions on problem solving skills and weight loss at 8 weeks, which     will inform a subsequent randomized controlled efficacy trial.   "
83544|NCT02192463|"     Study to determine the relative bioavailability of different oral Viramune Extended Release     (ER) formulations compared to Viramune® Immediate Release (IR) tablet   "
83545|NCT02192450|"     The purpose of this study is to determine whether insulin degludec compared to insulin     glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the     greatest potential benefit from optimised insulin treatment, which are patients with type 1     diabetes and high risk of nocturnal severe hypoglycaemia.   "
83926|NCT02187471|"     DS 5565 will be better than placebo (sugar pill without active drug) in managing fibromyalgia     pain and will be well tolerated.   "
83512|NCT02192879|"     This study aims to compare the efficacy and safety of three alternative methods of analgesia     in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA),     2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3)     patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB     may improve recovery and decrease postoperative pain scores in addition to other benefits     such earlier return of bowel function and shortened length of hospital stay, although some     practitioners have voiced concerns about the safety and efficacy of these techniques in     patients after liver resection who may develop postoperative coagulation abnormalities. The     investigators plan to enroll a total of 150 patients (adults >/= 18 years of age who meet     study criteria) scheduled for complex liver resection surgery in this study, who will then be     randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores     will be collected in PACU and throughout the patient's hospital stay as well as routine blood     tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to     measure renal function. The study team will also collect additional data prospectively on all     patients enrolled in the study; these parameters will include age, sex, type of operation     performed, length of operation, volume of intraoperative blood loss, volume of intraoperative     fluid administration including blood products, daily postoperative intravenous fluid     administration, length of time to first feeding, day of epidural catheter removal, length of     hospital stay and incidence of major postoperative complications (surgical, respiratory,     cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will     undergo rigorous statistical analysis using the appropriate statistical techniques to     determine the outcomes. The investigators propose that epidural and/or paravertebral     analgesia may improve recovery times and decrease hospital length of stay, which would be     beneficial for the patient as well as decrease hospital costs. In addition, if better     postoperative pain management scores can be achieved with epidural or paravertebral     analgesia, and no significant prolonged postoperative coagulopathy is associated with     patients undergoing major hepatic resection surgical procedures, these regional analgesia     strategies can be considered a safe option for pain management in this patient population.   "
83513|NCT02192866|"     Food allergies are now a major problem. These experiments involve getting blood from people     with food allergies and from people without food allergies. The blood collected will be used     to answer questions and find information about peanut and other food allergies.      Samples will come from:        -  People signed up by the investigators at the University of Colorado Denver        -  University of North Carolina and Massachusetts General Hospital where people have been          treated for peanut allergies        -  University of North Carolina, Massachusetts General Hospital, National Jewish Health and          The Children's Hospital in Denver where people have taken part or will take part in          clinically indicated oral food challenges.      Blood and health histories from the University of North Carolina, Massachusetts General     Hospital, National Jewish Health, and The Children's Hospital will not have personal     information linked.      The specific aims of this experiment are:        1. Come up with a lab test that will predict how bad an allergic reaction will be to          peanuts.        2. Find out what part of a peanut causes allergic reactions.        3. Come up with preventions that can block peanut allergies.        4. Find the strongest proteins in walnuts.   "
83514|NCT02192853|"     The investigators want to estimate both the endothelial and the plasma activity of dipeptidyl     peptidase 4 during different doses of sitagliptin in healthy subjects and patients with type     2 diabetes. Furthermore, the investigators want to investigate whether the current clinical     dose of 100 mg of sitagliptin is sufficient to inhibit both the plasma and the endothelial     activity of the enzyme dipeptidyl peptidase 4.   "
83518|NCT02192801|"     Patients with classical bladder exstrophy undergo many surgical interventions with secondary     urinary tract infections complicating their course. lately primary definitive surgical     correction of this congenital anomaly has been implemented with satisfactory results.     Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical     surgical complications can potentially damage their kidneys in the long-term. therefore we     decided to evaluate renal function in the long-term in these patients.   "
83519|NCT02192788|"     This study aims to probe the effect of SBRT as a treatment oligometastases of prostate     cancer, regardless of basal treatment received, and I know the response, biochemical control,     the progression-free survival as well as their impact on quality of life.      Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated     by SBRT.      Secondary Objectives: Analyzing biochemical progression rates, progression-free survival,     chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of     patients before and after treatment   "
83520|NCT02192775|"     The purpose of this study is to determine the clinical efficacy of MV-NIS (measles     virus-sodium iodide symporter) therapy for people with relapsed/refractory myeloma when given     with cyclophosphamide   "
83521|NCT02192762|"     This is a pilot study of a withdrawal regulation training program compared to relaxation     training for individuals that are interested in smoking cessation.   "
83522|NCT02192749|"     Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered     intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is     safe and will induce a therapeutic effect in autism patients.   "
83523|NCT02192736|"     Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived     mesenchymal stem cells (UC-MSC) administered intra-nasally to 20 patients is a safe and     useful procedure for inducing improvements in pulmonary function and quality of life in     patients with asthma.   "
83524|NCT02192723|"     The purpose of this study is to compare the efficacy and side effects of 6 commonly used     antipsychotic drugs in the treatment of schizophrenia in a Chinese population.   "
83525|NCT02192710|"     Rationale:      The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug     premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so     coordination between departments and operating room, exposed to the risks of side effects and     failure and this variability action. Alternative means were evaluated, such as the presence     of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.      Electronic tabs are small devices; light, easy to use with age-specific and interactive     programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety     and distract children compare to preoperative medication.      Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10     years old programmed for a short term and low level of pain outpatient surgery. My pass score     will be measured when arriving at the hospital, at the time of the separation with the     parents, at the time of the anaesthetic mask induction and after the surgery.      118 patients will be randomized as follows :        -  Arm 1 : Hypnovel® (midazolam)        -  Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon          area.   "
83526|NCT02192697|"     Purpose of the study is to determine the following in patients with non-small cell lung     cancer (NSCLC) harboring EGFR activating mutations.        -  the safety and tolerability of ASP8273.        -  the pharmacokinetics (PK) of ASP8273.        -  the antitumor activity of ASP8273.   "
83527|NCT02192684|"     Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and     public health burdens in the United States. That these diseases appear to co-exist and     together increase one's risk of cardiovascular disease renders investigation into their     shared pathophysiology even more urgent. Investigators will assess prevalence of insulin     resistance, a precursor to diabetes, among overweight patients with OSA. Among those at     highest risk of diabetes, investigators will randomize participants to pioglitazone or     placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or     insulin secretion. In a separate intervention, investigators will evaluate the     cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in     patients with OSA. Investigators will also study subjects from the community without known     sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea     using clinical screening questionnaires.   "
83528|NCT02192671|"     The purpose of the investigators' study is to prospectively compare the safety and efficacy     of hepatic resection to radiofrequency ablation for hepatocellular carcinoma in patients with     portal hypertension.   "
83529|NCT02192658|"     According to the recent World Report on Disability, around 15% of the world population lives     with a disability and 80% of people with disabilities (PWD) live in developing countries.     More and more evidence show that PWD are more likely to be poor, vulnerable to physical and     sexual violence, and to have less access to education. Therefore, PWD are likely to have an     increased risk for HIV infection, potentially being a key population in regard to this     epidemic.      The vulnerability of PWD was recognized in 2007 by the United Nations Convention on the     Rights of Persons with Disabilities. However, data on the extent how PWD are affected by HIV     is still very limited. As a result, PWD are usually overlooked by National AIDS Control     Programmes and few projects specifically targeting them have been developed.      Recognizing the need for appropriate and reliable data to help protect the rights of PWD and     achieve a better inclusion of disability in National AIDS Control Programmes, the Institute     of Research for Development (IRD), the Institut de Formation et Recherche Demographique     (IFORD) and Handicap International (HI) propose this study that aims to provide quantitative     and qualitative data on the vulnerability of PWD to HIV infection in Cameroon and Burkina     Faso, in order to define if this vulnerable population is also a Key Population in relation     to the HIV epidemic. This study adopts a multidisciplinary approach (quantitative and     qualitative methods). Quantitative data are collected only in Cameroon.      Only the quantitative study is described here.   "
83530|NCT02192645|"     The purpose of this study is to determine whether Sanfujiu is effective and safe in the     treatment of persistent allergic rhinitis.   "
84271|NCT02183233|"     The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC)     in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo     controlled trial during a 28-day treatment duration.   "
83531|NCT02192632|"     The purpose of this study is to evaluate the efficacy and tolerability of this combination     gel compared with BPO monotherapy in Korean patients, and test clinical practicability of     dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable     irritations.   "
83532|NCT02192619|"     The registry aims to document epidemiologic data, treatment and long-term outcome as well as     quality of life of patients with APL. Additionally, a biobanking project for further     translational studies is integrated.      Prospective population-based non-interventional and non-randomized multicenter registry.   "
83533|NCT02192606|"     The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal     cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice     laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial     comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by     residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be     randomized to either 2D versus 3D.   "
83534|NCT02192593|"     This is a randomized controlled trial, examining the effects of a computerized,     internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a     schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices).     Participants are randomized to one of two conditions: either to receive the 10-session     computer-based program on a weekly basis, or to their usual care at their mental health     clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It is     hypothesized that the participants who participate in the CBT program will have significant     improvements in the severity of their auditory hallucinations, as well as their associated     distress, compared to the participants receiving usual care.   "
83535|NCT02192580|"     Urinary tract infections (UTI) are a common and important clinical problem in childhood.Upper     urinary tract infections (ie, acute pyelonephritis) may lead to renal scarring, hypertension,     and end-stage renal disease.Pathogenesis of acute pyelonephritis (APN) is associated with     urinary tract anatomy and function, bacterial virulence factors, the host innate immune     system and production of free radicals. Oxygen-free radicals and oxidative stress play a role     in renal scar formation after an APN. Oxygen-free radical scavengers and antioxidants can     reduce tissue damage and renal scaring during acute pyelonephritis.we want to publish a study     that indicates that antioxidant therapy with omega-3 given to children with pyelonephritis     may indeed lower the risk for renal scarring.      Several studies show that omega-3 alleviated oxidative stress and inflammation.This study is     a simple randomized clinical trial (RCT) evaluating the effect of omega-3 in addition to     antibiotic on preventing renal scaring after acute pyelonephritis in children. This     randomized clinical trial on 60 patients in 2 groups (intervention & control) is     conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings,     and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute     pyelonephritis were enrolled into a clinical trial. Patients with neurogenic bladder,     systemic hypertension, obstructive uropathy and high grade vesicouretera are     excluded.Patients in Intervention group are administered omega-3 based on body weight in     divided doses in addition to antibiotic regimens and patients in control group received     antibiotic regimens without omega-3. Primary outcome is the development of renal scar by     doing DMSA renal scan on the 7th day of admission and four to six months after the     intervention and compared between groups.Also,measurement of urinary biomarker of acute     kidney injury (NGAL) three days after antibiotic or omega-3 administration for assessing of     subsequent scarring in both groups will be done . Secondary outcome is the incidence and     severity of renal scarring after pyelonephritis and response to treatment between two groups.   "
83536|NCT02192567|"     This is an open-label, sequential dose escalation and expansion study to evaluate the safety,     and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.   "
83537|NCT02192554|"     To follow-up on the safety of subjects who were previously treated in a double-blind trial of     brexpiprazole.   "
83594|NCT02191787|"     Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and     the optimal time for blood sampling   "
83538|NCT02192541|"     Background:      - Some people have cancers that don t respond to standard treatments. In these cases, doctors     may try to use drugs to slow the growth of the cancer.      Objectives:      - To test the safety and efficacy of the drug combination of ganetespib and ziv-aflibercept.      Eligibility:      - Adults age 18 and over with advanced cancer of the colon, lung, urinary tract, and     sarcomas.      Design:        -  Participants will be screened with medical history, blood tests, and scans to measure          their tumors.        -  Participants will have one or two eye exams, with dilating eye drops.        -  Participants will get the study drugs at the clinic as an infusion in a vein. Ganetespib          will be given once a week on the same day for 3 weeks in a row, followed by a 1-week          rest period. Ziv-aflibercept will be given once every other week. The drugs will be          given in 28-day cycles.        -  Participants may have a small piece of their tumor collected once or twice. This is done          using a small needle during computed tomography (CT), magnetic resonance imaging (MRI),          or ultrasound scan.        -  Participants will have their blood pressure checked at each visit. They will check it at          home every day of the study.        -  Participants may have one or more whole-body PET scans with 89Zr-panitumumab. A small          amount of a radioactive chemical will be injected through a tube in an arm. Participants          will lie on a bed that slides in and out of the donut-shaped PET scanner. They will have          small amounts of blood drawn.        -  Participants may stay in the study as long as they are tolerating the drugs and their          tumor is not getting worse.   "
83539|NCT02192528|"     We will use a retrospective data analysis to evaluate the association of the two vitamin D     metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac     surgical patients. The occurrence of several postoperative adverse events such as myocardial     infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from     cardiac surgery to discharge. In addition, we will assess the association of the two vitamin     D metaboolites with the duration of mechanical ventilatory support and intensive care unit     stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according     to vitamin D metabolite levels.   "
83551|NCT02192359|"     This phase I trial studies the side effects and best dose of carboxylesterase-expressing     allogeneic neural stem cells when given together with irinotecan hydrochloride in treating     patients with high-grade gliomas that have come back. Placing genetically modified neural     stem cells into brain tumor cells may make the tumor more sensitive to irinotecan     hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural     stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.   "
83552|NCT02192346|"     The goal of this study is to find the highest dose of α-TEA that can be given to patients     safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in     patients' blood.      Additional goals of this study are to monitor the effect on tumors, to check for specific     immune cells circulating in the blood, and to see if there are certain features of tumors     that make it possible to predict the response to α-TEA.   "
83540|NCT02192515|"     The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy     Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center,     placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single     center, randomized, open-label study that consists of two sequential two-way crossover     studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg     group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In     cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2     subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to     XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study     drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In     cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects)     to receive study drug in the sequence shown below.      Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose =>     XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d.,     multiple dose (fed)      Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) =>     XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple     doses (fasted)   "
83541|NCT02192502|"     The purpose of this study is to evaluate the safety of a standard volume replacement called     HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an     alternative to pure fluid replacement solutions that are associated with problems after     surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4     (Voluven) will be evaluated by examining its effects on kidney function, and coagulation     parameters and platelet (part of the blood that help it clot) function.      Participants will be randomized (like flipping a coin) to receive one of two possible volume     replacements during surgery, if fluid volume decreases enough to need replacement with one of     the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or     human albumin 5% (a protein-containing solution).      To examine kidney function, urine will be-sampled when the participant is put under general     anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours     after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established     line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24     hours after surgery and every morning during the participants postoperative ICU stay.      Additionally, health and recovery information will be recorded from the participant's medical     record. We will phone participants around 90 days and one year after surgery to ask a few     questions about one's health and recovery. We will also record blood sample analysis results     from follow up appointments within the first year after surgery. If this analysis is not     conducted at the Cleveland Clinic, with permission, we will obtain the results from a     treating physician.   "
83542|NCT02192489|"     This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy     of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.   "
83543|NCT02192476|"     california tri-pull taping (CTPT) method might be effective in reducing shoulder subluxation,     pain, and improving active flexion range (AFLXN) range of motion, and functional recovery     after stroke.   "
83546|NCT02192437|"     Studies in laboratory models indicate that dietary methionine restriction (MR) enhances     longevity and produces short- and long-term metabolic changes that are consistent with a     healthy lifespan. The present study was designed to establish levels of dietary methionine or     methionine and cysteine that induce physiological changes in healthy adults like those     observed in rodent studies .   "
83547|NCT02192424|"     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive     deterioration in the function of the pancreatic beta-cells, which are the cells that produce     and secrete insulin (the hormone primarily responsible for the handling of glucose in the     body). The investigators propose a randomized controlled trial to determine whether     intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve     pancreatic beta-cell function and maintain glycemic control early in the course of type 2     diabetes.   "
83548|NCT02192411|"     Endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe     and effective treatment for varicose veins. Essential to the successful ablation of refluxing     veins by endovenous laser treatment is the use of tumescent anesthesia. One of the components     of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While lidocaine can     be used safely as long as serum concentrations remain low, its use carries the risk of     lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is desirable to     use the minimum effective concentration of lidocaine needed to manage pain during a     procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in tumescent     anesthesia will function as well as the standard dose for pain management in endovenous laser     treatments. If we find that this is the case, we will be able to reduce the risk of lidocaine     toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort     throughout the procedure. This will be achieved through a direct comparison of intra- and     post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine     concentration or the standard lidocaine concentration.   "
83549|NCT02192398|"     Combination of guanfacine with opioid medication as a standard treatment for chronic pain.   "
83550|NCT02192372|"     Prevention of contrast induced nephropathy after interventional cardiologic procedures     deserves close interest because of its association with prolonged hospitalization, increased     cost and increased in hospital and long term mortality rates. An observational prospective     cohort study was designed to determine whether metabolic syndrome predicts the development of     contrast induced nephropathy after elective percutaneous coronary intervention.   "
85532|NCT02166489|"     This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)     therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).   "
83553|NCT02192333|"     This randomized clinical trial studies survivorship care in reducing symptoms in young adult     cancer survivors. Survivorship care programs that identify the needs of young adult cancer     survivors and ways to support them through the years after treatment may help reduce     symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult     cancer survivors.   "
83554|NCT02192320|"     To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative     treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders   "
83555|NCT02192307|"     This study will compare the safety and effectiveness of two water-based potassium oxalate     desensitizers on existing dentinal hypersensitivity.   "
83556|NCT02192294|"     This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period     crossover study in healthy subjects.   "
83557|NCT02192281|"     The purpose of this study is to determine whether Playworks has an impact on student and     school outcomes such as physical activity, behavior, and academic performance.   "
83558|NCT02192268|"     The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources     may have positive effects in this population of children with acute respiratory illness.      Thinking about this physical and physiological issue and due to the absence of a study that     has evaluated the effectiveness of these instruments in patients with pneumonia, the     objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in     children hospitalized for community-acquired pneumonia.   "
83559|NCT02192255|"     This multisite pragmatic clinical trial was designed to assess the effectiveness of a single     scripted telephone call to diabetes patients who (a) were currently above recommended     clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a     new medication for that specific clinical domain. The goals of the intervention were to     improve primary adherence and persistence to the newly prescribed medication and to improve     control of glucose, blood pressure, and lipids.   "
83560|NCT02192242|"     The pathophysiology of acute ischemic pain is not well established. The aim of the present     study was to investigate acute ischemic pain in humans with a view to establish a scientific     model to perform future studies. The investigators examined whether peripheral nerve damage     and acute inflammation occur during short episodes of acute ischemia.   "
83561|NCT02192229|"     Abstract:      The main objective of the proposed study is to examine the Safety and Efficacy Evaluation of     the Dose Regimen of Vitamin D 50,000 IU (Biodal) tablet supplementation in the treatment of     population with vitamin D deficiency.      A randomized, double-blind placebo, Parallel design comparing vitamin D with Placebo will be     conducted on 60 Healthy males and females with vitamin D deficiency, age from 18 to 49 years     who attend the rehabilitation clinics at Jordan University Hospital .Participants who met the     inclusion criteria will be asked to sign an informed witnessed consent form. Results obtained     are expected to assess the safety and efficacy of the dose regimen used in this study as per     Biodal SmPC. This study will also contribute to the global body of knowledge in this field.     The major findings generated from this study could open certain avenues for further research     through the association of the status of vitamin D in serum .   "
83595|NCT02191774|"     Medical abortion performed in the womens home has shown to be safe and acceptable up to 9     weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally     effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of     gestation.   "
85978|NCT02160626|"     The main objective of this study is to evaluate the dose-response relationship of two     concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions     (target lesions) compared with a matching A-101 Solution Vehicle.   "
83562|NCT02192216|"     Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma     patients. The Danish nation-wide training and rehabilitation offer 'Body & Cancer' offers     intensive resistance and endurance training to all Danish cancer patients receiving     chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but     the potential of the training to preserve or improve muscle mass is uninvestigated.      Furthermore, the underlying biological mechanisms of treatment and/or exercise induced     changes in muscle mass in cancer patients remains uninvestigated.      Thus, the primary purpose of the present study is to investigate changes in body composition     during chemotherapy and after resistance and aerobic training combined with protein     supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to     investigate the underlying biological mechanisms of muscle mass regulation in biopsies     obtained before and after a control period as well as after 10 weeks of exercise, both during     chemotherapy.      We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer     patients during chemotherapy as compared to a control period during chemotherapy alone.   "
83563|NCT02192203|"     This research study is being carried out to determine the possibility that a new medication     causes allergic reactions. This new medication contains two active ingredients (diclofenac     and menthol) together in a gel and is being developed to treat mild to moderate pain and     inflammation, such as acute sport injuries, and sprains and strains. Approximately 240     participants will have the medication (gel) applied to the skin on a small area of the upper     back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation     in this research study is voluntary, requiring participants to visit the study clinic on 17     occasions for about 45 minutes each visit. During the visits, doctors or trained staff     members will examine the amount of redness, swelling, and other signs of irritation (if any)     of the skin where the medication (gel) was applied.   "
83564|NCT02192190|"     The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain.     The study drugs will be given as an injection under the skin and as an oral capsule. The     study will last about 28 weeks for each participant.   "
83565|NCT02192177|"     Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially     late second and third trimester. We aimed to investigate the role of apoptosis in     etiopathogenesis of obstetric cholestasis.   "
83566|NCT02192164|"     Pilot observational study to describe the relationship between the smoking status of a     psoriatic individual and the success of etanercept therapy in psoriasis treatment   "
83567|NCT02192151|"     To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability     of PHN131 in healthy volunteers   "
83590|NCT02191852|"     Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid     reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs)     and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment     of individual antioxidant compounds contained in the product and to investigate whether or     not some of them accumulate in target tissues such as skin, BMCs and plasma   "
85533|NCT02166476|"     Carbavance, (meropenem/vaborbactam) is being compared to piperacillin/tazobactam in the     treatment of adults with cUTIs or AP   "
83568|NCT02192138|"     Research project objectives.      The project includes eight research hypotheses and eight corresponding study objectives. The     most relevant objectives are:        -  Analysis of lung function and gas exchange parameters in relation to the removed pleural          fluid volume and intrapleural pressure changes.        -  Evaluation of changes in lung and chest wall compliance and related changes in work of          breathing during therapeutic thoracentesis and pleural fluid withdrawal.        -  Study of the relationship between intrapleural pressure changes and cardiac function          assessed by echocardiography and alterations in serum natriuretic peptide A and B          concentration.        -  Comparative analysis of the reliability of the volume-pressure curve slope prediction          based on different variables measured before thoracentesis and real measurements of          ventilation and intrapleural pressure during thoracentesis.           2. Research methodology The study will be performed in 60 patients with pleural effusion          planned for therapeutic thoracentesis.      Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity     (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic peptide     concentration.      Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory     rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous     measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to enable     fluid drainage and intrapleural pressure measurement after completion of thoracentesis.      Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be repeated     in specific time points and compared in two subgroups (active physiotherapy to improve lung     re-expansion and passive lung re-expansion).      Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the     catheter will be removed.      Analysis.Signal analysis and visual multidimensional analysis performed with the use of own     computer programs will be the first step of the analysis. The identified relationships     between the analyzed parameters should allow to form physiological, medical, and statistical     hypotheses, as well to verify the analysis of previously obtained data .      Expected impact of the research project The study results will allow to define lung function,     blood gases and cardiovascular function in relation to changes in intrapleural pressure. Some     of these correlations had not been previously investigated. Our results may influence     management standards in patients who require therapeutic thoracentesis.   "
83569|NCT02192125|"     The study examines the possible application of the rehabilitation platform REWIRE.   "
83570|NCT02192112|"     Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during     XLIF has been demonstrated, it is hypothesized that more information may be gathered if a     greater section of the motor neural pathway was monitored (i.e., stimulation above the     surgical site and recording the subsequent muscle response in the lower limbs). Currently,     there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots     locally, but well-above the surgical site in this fashion.      This protocol is intended to evaluate the feasibility and reproducibility of using surface     stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and     record responses from the relevant innervated muscle groups of the lower limbs.   "
83571|NCT02192099|"     Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in     GLYX13-C-202.   "
83572|NCT02192086|"     The goal of the proposed study is to evaluate the efficacy of a goal-directed fluid     administration algorithm on early graft function in patients undergoing kidney     transplantation. Fluid administration has increasingly been scrutinized within anesthesia     related literature as an area for improvement, and the imbalance present between estimated     blood loss and total fluid administered for kidney transplants must be amongst the highest     case categories. Considering the patients are anuric for the majority of the procedure,     unguided administration of multiple liters of crystalloid appears antiquated.   "
83596|NCT02191761|"     This is an open-label, multi-center, dose escalation study in adult subjects with advanced     colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety,     tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally.     Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.   "
83573|NCT02192073|"     Biceps pathology typically includes pain in the anterior shoulder that is reproduced with     provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear     and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then     reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from     spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This     study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in     the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in     the shoulder).      Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open     subpectoral biceps tenodesis results in better function.   "
83574|NCT02192060|"     The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic     of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival     biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).   "
83575|NCT02192047|"     The investigators hypothesized that there will be a significant difference between the     effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on     cardiovascular disease, inflammation, insulin resistance and obesity.   "
83576|NCT02192034|"     Colorectal cancer is the second leading cause of death from cancer in the United States. Two     major barriers to successful colorectal cancer screening are appointment keeping and proper     bowel preparation. The purpose of this study is to test the efficacy of a patient navigation     program to increase colorectal cancer screening at Rush University Medical Center. The     investigators hypothesize that colorectal cancer screening will be improved for subjects who     utilize a patient navigator.   "
83577|NCT02192021|"     The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will     kill tumor cells locally and alter the tumor microenvironment to induce durable systemic     tumor-specific immunity.      The purpose of this study is to test a new method of experimental treatment for CTCL, using     small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens     of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy     agent. The overall goal of this study is to test the safety and effectiveness of these     patches. We also want to determine which micro-dose of the drug is the best to achieve the     best response. To make sure that we observe the effects of the very low dose of the drug and     not the MNA patch itself, we will also use a placebo (a patch without drug in some patients)     in addition to the doxorubicin coated patches. We will thoroughly evaluate the skin where the     patches are applied. Once the best dose is determined for use in the patch, we will also     begin to look at how well the patches work in clearing the skin.   "
83604|NCT02191657|"     The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of     different dosages of deferiprone in subjects with or without HIV infection.   "
83605|NCT02191644|"     This study examined whether dietary-induced reductions in lipoprotein-associated     phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma     affected metabolic profiles in PBMCs and plasma.   "
83606|NCT02191631|"     The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17     years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either     ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment     condition.   "
84272|NCT02183220|"     The objective of the study was to evaluate the efficacy, safety and tolerability of a single     peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid     in 2 episodes of moderate tension headache.   "
83578|NCT02192008|"     Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a     bacteria called Salmonella enterica. After ingesting contaminated food or drink, the     Salmonellae travel first to the gut, then the bloodstream, from where they can infect other     parts of the body. Antibiotics are used to kill the bacteria, but with increasing rates of     antibiotic resistance, this treatment is becoming less effective.      Two Salmonella variants, Typhi and Paratyphi, cause over 30 million cases of enteric fever     and more than 200,000 deaths per year, mostly in developing countries. While improved hygiene     and sanitation should eventually eliminate enteric fever, reduction of the disease burden in     the medium term is achievable through effective vaccination.      Vaccines likely to be available for mass vaccination are effective only against those     Salmonella strains that bear the Vi polysaccharide capsule protein. Strains that do not have     these capsule proteins, or have no capsule, will not be affected by vaccination and could     'fill' the space vacated by the capsulated strains. Indeed, enteric fever caused by S.     Paratyphi A which does not carry the Vi protein, has risen during the past decade and     accounts for more than half of all cases in some areas. Thus it is important that effective     vaccines are available to protect against infection by both capsulated and noncapsulated     Salmonella enterica. To develop such vaccines, we need a complete understanding of the human     immune response to both types, including the contribution of immunity in the gut and the     bloodstream, immune response to bacterial surface proteins, and the role of antibodies. How     much cross-protection there is between the types of typhoidal Salmonellae after natural     infection or vaccination is not known, but this is critical to vaccine development.      This project aims to fill in the knowledge gaps highlighted, by fully characterising the     infection process and immune response in enteric fever.   "
83579|NCT02191995|"     Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.   "
83580|NCT02191982|"     This study will look at the impact of a self-directed walking program on post-chemotherapy     survivors experiencing fatigue. It is hypothesized that the walking program will help lessen     fatigue.   "
83581|NCT02191969|"     This study will see if patient who undergo a physical activity intervention called Walk With     Ease report experiencing less fatigue and a higher quality of life during chemotherapy for     colorectal cancer than those who do not participate in this intervention.   "
83582|NCT02191956|"     This study aims to the test the efficacy and cost effectiveness of new service delivery     methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent     Training (BPT), for early onset disruptive behavior disorders.   "
83656|NCT02190981|"     The primary purpose of this study is to determine the accuracy of ultrasound in diagnosing     small bowel obstruction in emergency department patients, as compared to the criterion     standards of computed tomography, operative reports, or discharge diagnosis.      The secondary purposes of the study include evaluation of the effect of ultrasound for small     bowel obstruction on the patient length of stay in the emergency department and the     diagnostic utility of specific ultrasound findings in the diagnosis of small bowel     obstruction. The study will also examine the inter-rater agreement between point-of-care     sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.   "
85979|NCT02160613|"     The study hypothesis:      Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?   "
83583|NCT02191943|"     The aim of the planned in-vivo trial is to investigate the effectiveness of the caries     infiltration technique for the repression of caries progression.      Within the framework of this investigation it is intended that the hypothesis to be     substantiated is that carious cavities, which have been treated with the caries infiltration     technique, exhibit significantly reduced radiological progression than those cavities that     have been treated using standard preventive treatments.      In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at     each institution are to be treated with both, the infiltration technique and using     conventional fluoridation treatment in different sides of the mouth (split-mouth design).      The anticipated result of this trial shall deliver information on the long-term effectiveness     of caries infiltration to prevent the progression of existing approximal carious lesions, and     thereby enable an improvement in caries prevention within the scope of dental treatment.   "
83584|NCT02191930|"     The purpose of this trial is to determine        1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or          PR in the centrally reviewed restaging after six cycles of chemotherapy        2. Progression-free survival (PFS) 3 years after registration   "
83585|NCT02191917|"     Study 701-201 is a study in patients with late-onset Pompe disease (LOPD). The study will     test respiratory muscle strength initially and again after 24 weeks in subjects treated or     not treated with BMN 701 .   "
83586|NCT02191904|"     To ensure minimal cervical motion during the intubation of trauma patients is important for     the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.      Intubation is required to secure the airway in patient during an anesthesia management or a     mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for     intubations. The most widely used laryngoscope type is one with a Macintosh blade. However,     various types of laryngoscopes have been developed to be used for in case of difficult     intubations, the intubation of the patients with head and neck trauma, or the intubation     attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly     developed laryngoscopes, integrated with an optical view system.      The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently     introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type     laryngoscopes, having an angle of 46° at the end of blade and including a camera system that     magnifies the image.      The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed     type of laryngoscope, including optical imaging system. There is a channel on the device for     the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before     the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which     provides glottis display without any deviation in the normal position of the oral, pharyngeal     or the tracheal axes.      In the literature, there are many studies comparing the effects of these newly developed     laryngoscopes on cervical motions in different scenarios with cadavers and normal patients.     However, in these studies, individual vertebral motion was reported during the placement of     the tube, while the angulation of the head and neck and the difficulty of the intubations     were not clear.      In this study our first hypothesis was cervical motion during endotracheal intubation in     Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one     was the endotracheal intubation time is similar to the Macintosh that is used more often.   "
83587|NCT02191891|"     Part A: To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)     of Xentuzumab (BI 836845) in combination with afatinib in patients with non-small cell lung     cancer with progression following prior treatment (EGFR TKI or platinum-based chemotherapy).      Part B: To evaluate the early anti-tumour activity of Xentuzumab (BI 836845) in combination     with afatinib in patients with EGFR mutant non-small cell lung cancer with progression     following prior irreversible EGFR TKIs.      Part A and B: To evaluate the safety and pharmacokinetics of BI 836845 in combination with     afatinib in patients with non-small cell lung cancer   "
83588|NCT02191878|"     This study is an open-label, multi-center, phase 1, dose escalation study with a phase 2     expansion cohort to determine the safety, pharmacokinetics and preliminary anti-tumor     activity of intravenous TKM-080301 in subjects with advanced hepatocellular carcinoma (HCC).      This study is being done to:        -  Test the safety and tolerability of TKM-080301 in subjects with advanced hepatocellular          carcinoma        -  Find the highest dose of TKM-080301 that can be given without causing side effects,          called the maximum tolerated dose (MTD).        -  Provide a preliminary assessment of anti-tumor activity of TKM-080301   "
83589|NCT02191865|"     The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score     5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics,     safety and tolerability of nintedanib, in comparison with a control group with normal hepatic     function following oral administration of nintedanib as single dose.   "
83621|NCT02191436|"     Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter     study. Multicenter cross sectional study of patients with hemophilia and their families   "
84297|NCT02182635|"     The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily     the long-term efficacy of Ba253BINEB is also investigated.   "
83591|NCT02191839|"     Protocol Summary STUDY DESIGN A pilot, prospective, double blind, randomized, placebo     controlled study.      STUDY POPULATION Patients assigned to elective CABG with cardiopulmonary bypass (CPB) at the     Department of Cardiothoracic Surgery, Soroka University Medical Center.      OBJECTIVE To evaluate anti-inflammatory effects, effects on organ function preservation, and     postoperative blood loss reduction following AAT-1 administration in patients undergoing CABG     with CPB.      PRIMARY ENDPOINT Postoperative organ function preservation and blood loss following     preoperative single-dose AAT-1 administration.      SAMPLE SIZE CONSIDERATIONS A cohort of 20 patients will be recruited. Patients will be     randomized to receive either AAT-1 or placebo prior to surgery. Whereas this is a proof of     concept pilot study, statistical significance is not the primary objective.      INCLUSION CRITERIA 1. The study population will comprise patients between 40 and 70 years of     age, irrespective of gender, at low or intermediate operative risk (calculated Logistic     Euroscore stratification of 5% or less), assigned to elective CABG with CPB. Recruitment     depending on patients informed consent.      EXCLUSION CRITERIA Co-existing conditions including:        1. Coagulation abnormalities        2. Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of          less than 60% of predicted.        3. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%,        4. Abnormal liver function tests        5. Uncontrolled diabetes mellitus,        6. Severe peripheral vascular disease        7. Prior cerebrovascular neurological event.        8. Abnormal left or right ventricular function.        9. Treatment with warfarin or thienopyridine class of anti platelet agents.   "
83592|NCT02191826|"     Clinical proof of concept study to evaluate SOM0226 efficacy in TTR Amyloidosis.   "
83593|NCT02191813|"     Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by     Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression)     activated by UV radiation   "
83597|NCT02191748|"     Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented     areas of skin. In the United States, vitiligo affects 1% of patients, causing not only     changes in the color of skin, but also significant cosmetic concerns and quality of life     issues. Current treatment modalities, which include topical corticosteroids, intralesional     corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in     inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment.     There is a need for new, effective modalities to treat patients with otherwise refractory     vitiligo.      Needling is an office based procedure that theoretically transposes healthy, pigmented skin     cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of     needling as a novel treatment for vitiligo had promising results but were limited by small     sample size and subjective results.      The proposed randomized control trial (RCT) will further investigate the use of needling to     treat vitiligo. It differs from the previous studies in that it seeks to identify the cause     of clinical benefit by comparing needling alone to needling with corticosteroid, examines a     larger number of patients, and quantifies improvement using confocal microscopy. Confocal     microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has     been used in the past to diagnose cutaneous pigmentary conditions. This study would be the     first RCT of needling in vitiligo to use an objective measure to quantify results, thus has     the potential to establish needling as a novel, effective treatment for vitiligo and to     evaluate the utility of CFM for monitoring response to treatment.   "
83598|NCT02191735|"     This clinical investigation is designed to demonstrate the performance characteristics of the     RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the     point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.   "
83599|NCT02191722|"     We believe, that the results of this study will show that children learn from the comic book     about their disease, and are now more aware and less frightened about it, and increase their     compliance.   "
83600|NCT02191709|"     Study to investigate the relative bioavailability of orally administered dextromethorphan     syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female     subjects who are extensive metabolisers for CYP 2D6   "
83601|NCT02191696|"     The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the     IMED-4   "
83602|NCT02191683|"     Study Hypotheses:        1. Anaemia, which is frequent before conception as well as during early pregnancy, affects          metabolism and foetal growth trajectories, influencing the risk of NCDs in the          offspring.        2. Anaemia from conception till end of 2nd trimester is most detrimental for foetal and          newborns' health, compared to 3rd trimester anaemia.        3. Anaemia from conception till end of 2nd trimester affects foetal and newborns health          through poor placental development reflected in increased villous branching and changed          umbilical and uterine blood flow.        4. Anaemia in early pregnancy disrupts the vascular endothelial growth factor A          (VEGF-A)/placental growth factor (PlGF) balance and the insulin-like growth factor (IGF)          axis resulting in poor placental development, and poor health of newborns. This may be          reflected in specific methylation patterns.        5. Anaemia's impact on the risk for NCDs in the offspring may be mediated via epigenetic          mechanisms, including changes in DNA methylation patterns.   "
83603|NCT02191670|"     Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation.     Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue     plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction     in usual routine treatment after market launch   "
83607|NCT02191618|"     The study is a prospective, multicenter single-arm cohort. Patients with wide neck     bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment.     In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary     effectiveness outcome of the study is the likelihood of complete intracranial aneurysm     occlusion on the 1 year angiogram as adjudicated by a core laboratory.   "
83608|NCT02191605|"     Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal     exposure to marijuana can have lasting negative effects. However, current answers to this     problem are failing to reach most women who use marijuana while pregnant. This project will     develop and begin testing two technology-based, highly practical interventions that could     reduce the number of children who are prenatally exposed to marijuana.   "
83609|NCT02191592|"     The purpose of this research study is to test a new way of measuring the severity of tinnitus     using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will compare the     relationship with this tool with another widely used questionnaire. Previous studies we have     done suggest there are different patterns of tinnitus bother; we plan to explore how often     these patterns occur, and how many patterns of tinnitus bother there are. And lastly we want     to test how reliable this type of testing is for measuring the amount of bother people     experience from their tinnitus.      Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.      Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of     bother individuals have from tinnitus.   "
83610|NCT02191579|"     This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative)     treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic     migraine.   "
83611|NCT02191566|"     After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given     chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and     oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was     administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).   "
83657|NCT02190968|"     Many patients report residual depressive symptoms despite seemingly successful treatment.     With the investigators' previous funding, we developed - Mindful Mood Balance - an online     treatment that targets RDS by teaching specific emotion regulation and depression     self-management skills that are entirely compatible with antidepressant treatment. The     investigators now propose a controlled study to determine whether MMB is more effective than     usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery     format would provide high fidelity and low-cost empirically supported management of residual     symptoms, leading to more robust remission, improved functioning and sustained recovery from     MDD over time.   "
83612|NCT02191553|"     Mindfulness can be considered as a family of complex attentional and emotional regulation     strategies that promote the cultivation of well-being and emotional balance. The practice of     mindfulness produces the development of a consciousness that unfolds moment to moment, open     and unprejudiced in the present moment, here and now. Despite its extensive benefits, the     practice of mindfulness requires a significant commitment in time and effort, which limits     the potential for its dissemination. The studies to narrow the differential effects of the     various exercises based on mindfulness, will further enhance their effectiveness and they can     guide the practice sequence according to user needs. In this paper we will research     mindfulness electroencephalographic correlates of as four different exercise programs     included in mindfulness-based cognitive therapy (MBCT) and stress reduction program based on     mindfulness (MBSR) as well as its effect on several psychological variables.   "
83613|NCT02191540|"     Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of     Abnoba viscum F 20mg in patients with malignant pleural effusion   "
83614|NCT02191527|"     The general goal of the proposed study is to evaluate the cost-effectiveness of POC     technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting     performed within MCH services to improve maternal and infant health.      A prospective, quasi-experimental study will be done in Cabo Delgado province, where health     facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and     infant health will be measured.   "
83615|NCT02191514|"     Annually 12.000 people i Denmark suffer from a stroke. Treatment for ischemic stroke is     available, but only 12% of stroke patients receive it.      The treatment is only available within a time frame of 4,5 hours from symptom onset, thus the     Emergency Medical Services (EMS) is essential to fast and effective stroke treatment.      The aim of this study is:        1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the          EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast          and correct EMS-response.        2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke,          create a baseline for future comparison and generate explorative hypotheses for          forthcoming interventions.      The overall aim of this study is, to ensure the best possible prehospital care for all stroke     patients. The study will determine, if the EMD is at a high and international level in     regards to stroke recognition, and if there is a potential to decrease on-scene time. This     will serve as future comparison and have an effect on the structure and future education in     the prehospital services, and potentially improve the outcome after acute ischemic stroke.   "
83616|NCT02191501|"     The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of     the gastric pylorus to delay gastric emptying and treat obesity.   "
83617|NCT02191488|"     Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not     have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon     can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the     patients tumor by looking at the MRI images that were taken of the patients brain before     surgery. However, the surgeon does not have any good way to tell if the entire tumor has been     removed or not. Removing the entire tumor is very important because leaving tumor behind may     allow it to grow back which could decrease the chances of survival.   "
83618|NCT02191475|"     Selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic     therapy (Hai Zheng Energy Star ®) combined with piperacillin / tazobactam (tazocin ®) scheme,     compared with the classical scheme, evaluate its efficacy, safety index.   "
83619|NCT02191462|"     The purpose of this study in to analyse the way in which the body processes Niagen     (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are     given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the     dose.   "
83620|NCT02191449|"     Warfarin therapy is usually monitored using the international normalized ratio (INR), and     prolonged INR means coagulation impairment that can leads elevating transfusion requirement     after operation. This study was designed to assess the relationships with warfarin and TEG     values related to transfusion amount, to set up blood transfusion strategy in patients on     atrial fibrillation undergoing cardiac surgery.   "
83622|NCT02191423|"     Rationale and Hypotheses of the Current Research: the investigators speculate that mothers     suffering from PPD exhibit high levels of depression and low levels of OXT, hence     experiencing the interaction with their child as less rewarding, which in turn promote     further depressive symptoms and interfere with child development. While dyadic psychotherapy     has been studied in this context, it is unknown which depressed women will respond to this     type of therapy, and whether such a response is mediated by the pro-bonding effect of     oxytocin.      The aim of this study is three-fold:        1. To study the effect of the administration of a single dose (24IU) of oxytocin on          cerebral circuit processing and connectivity of empathy and attachment.        2. To examine whether the clinical response of mothers suffering from postpartum depression          to short term dyadic psychotherapy (based on improved mother-child interactions) can be          predicted by a unique brain response pattern to oxytocin.        3. To assess the relationship between levels of oxytocin in mother and baby and the          effectiveness of psychological dyadic treatment on mothers suffering from postpartum          depression.   "
83658|NCT02190955|"     The purpose of this study is to learn about patient, caregiver and healthcare worker     perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients     enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to     participate in this study.   "
83659|NCT02190942|"     The purpose of this study is to provide validation of patient-reported data in the VCRC     Patient Contact Registry by comparing patient-reported data with data provided by the     physician who is the primary provider caring for the patient's vasculitis. Patients enrolled     in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with     polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with     polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN),     and Takayasu's arteritis (TAK) were invited via email to participate in this study.   "
85980|NCT02160600|"     To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass     evaluation in terms of appropriateness of treatment received after diagnosis. To determine     SBDECT diagnostic accuracy.   "
83623|NCT02191410|"     The stroke volume variation (SVV), measured using the Vigileo-FloTrac system (Edwards     Lifescience, Irvine, CA), has been shown to able to predict fluid responsiveness during     one-lung ventilation (OLV) in patients undergoing pulmonary lobectomy (sensitivity: 82.4%,     specificity: 92.3%).1 Many parameters such as tidal volume (TV),1-2 positive end-expiratory     pressure (PEEP),3 respiratory rate (RR), 4 chest and lung compliance,5 heart rate and rhythm,     and ventricular function and afterload,6-7 all have been documented to have effects on the     SVV.      SVV is calculated as the variation of beat-to-beat SV from the mean value during the most     recent 20 seconds of data: SVV = (SVmax − SVmin)/SVmean, where SVmax, SVmin, and SVmean are,     respectively, the maximum, minimum, and mean SV determined by the system.      SVV may not be sufﬁciently sensitive to predict fluid responsiveness in patients with right     ventricular (RV) dysfunction due to concomitant increases in RV afterload, that lead to a     decrease in preload variation and subsequent inaccuracy in SVV measurements.8      OLV may increase airway pressure, resulting in increases in the RV afterload, end-diastolic     volume, and stroke work index, thus impeding RV function.9-11The increases in the right     ventricular afterload may exaggerate the cyclic variation in stroke volume.12      In the authors' previous study,9 they found that the high-frequency positive-pressure     ventilation (HFPPV) was superior to continuous positive-airway pressure (CPAP) for OLV,     resulting in significantly higher RV ejection fraction, lower RV afterload and higher     arterial oxygenation, whereas the former limiting the adequate operative field visualization     during video-assisted thoracoscopic surgery (VATS).13      The effects of the nondependent lung ventilation with HFPPV and CPAP on the SVV and fluid     responsiveness during OLV has not yet been studied.   "
83624|NCT02191397|"     This multi-centre study will follow a randomised, double-blind, parallel-group,     active-controlled design and will evaluate the efficacy, safety and tolerability of bupropion     extended-release (XL) (300 mg/day) compared with escitalopram (10-20 mg/day) in outpatients     and inpatients with major depressive disorder (MDD). The total duration of the study will be     11 weeks consisting of three phases. The screening phase (phase I) will be lasting for 0-14     days, subjects will be randomised to bupropion XL or escitalopram in a 1:1 ratio for acute     phase treatment phase (phase II) for 8 weeks. There are 3 dose levels during this acute     treatment phase. The 3-dose level plan is designed to ensure each drug is titrated according     to the prescribing information and to reach an optimal clinical dose. Finally patients will     enter the taper phase (phase III) for up to 1 week to assess and reduce the possible     withdrawal symptoms.      In China almost all existing antidepressants are available on the market, but bupropion XL     has not yet been approved. This Phase III clinical trial will be used for the purpose of     registering bupropion XL in China.   "
83625|NCT02191384|"     The purpose of this study is to determine whether Orcinoside Capsule in different doses are     effective in the treatment of Depression.      And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in     the Chinese Patients with Depression.   "
83626|NCT02191371|"     One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral     microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational     anesthetics can be used during one-lung ventilation. However, there is still a controversy     which anesthetic would be more appropriate during one-lung ventilation in the perspective of     oxygenation and microcirculation. The investigators hypothesized that intravenous and     inhalational anesthetics may affect oxygenation and microcirculation differently during     one-lung ventilation.   "
83627|NCT02191358|"     This multicenter observational study aims to investigate the benefits of providing     pharmacogenetic testing with the YouScript Personalized Prescribing System which includes a     clinical decision support tool and individualized pharmacist recommendations to elderly     polypharmacy patients who are most at risk of adverse drug events. The YouScript system is     unique in identifying drug-gene, and drug-drug-gene interactions that are missed by existing     systems, and represent over 35% of significant interaction warnings. Data analysis will     assess the impact of recommendations for medication changes on clinical decision making,     patient outcomes, and healthcare resource utilization to determine which medications,     specialties, or patient segments derive the greatest benefit from this intervention. Data     gathered from patients enrolled in this study will be compared to patients matched on key     characteristics from Inovalon's MORE2 healthcare database.   "
83628|NCT02191345|"     Primary Aim A. To determine if listening to prerecorded guided imagery 3 times per week for 4     weeks will reduce state anxiety, perceived stress, burnout, compassion fatigue, and vicarious     trauma in Fronltine Service staff.      Primary Aim B. To determine if staff will continue to listen to guided imagery after the     first 4 weeks of the study is over.   "
83629|NCT02191332|"     Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV     RNA determination) and immunological activity (CD4 cells) despite switching from protease     inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).   "
83630|NCT02191319|"     Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)     and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to     Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and     liver enzymes.   "
83631|NCT02191306|"     Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on     Long-Term Antiretroviral Therapy      Intro:      It is well known that HIV treated with antiretroviral drugs increases the risk for coronary     artery disease. Studies have documented this with various methods including analyzing the     effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and     hypertension. Still other studies have looked at carotid and brachial artery intimal     thickness. Our study, then, aims to evaluate the relationship between HIV medications and     coronary atherosclerosis using a novel method. Coronary artery CT angiography is a relatively     new diagnostic procedure to evaluate heart disease in cardiac patients. We will apply this     test to HIV patients on longstanding antiretroviral therapy to directly examine their     coronary arteries to assess heart disease.      Hypothesis:      We hypothesize that HIV patients on antiretroviral therapy will have increased coronary     artery disease compared to the general population.      Methods:      This project will be conducted in collaboration between Florida Heart Center and Associates     in infectious Disease - two communities based infectious disease and cardiology practices. We     will identify all the HIV positive patients seen within a 1 month timeframe at the infectious     disease office. These patients will then be filtered by our exclusion/inclusion criteria.     After obtaining informed consent, we will draw blood from each patient to gather lab values     such as A1C, cholesterol, inflammatory markers, and other markers associated with coronary     artery disease. Each enrolled patient will then schedule and receive a 64 slide coronary CTA     at Florida Heart Center. The results of the CTA scans will be categorized in mild, moderate,     and severe coronary artery disease. The data, then, will consist of the parameters measured     on blood work, and the results of the coronary CTA.      Inclusion Criteria:      1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years.      Exclusion Criteria:      1. Patients with prior documented coronary artery disease, heart attack, stent placement, or     heart surgery.      Statistical Analysis:      We will conduct a multivariate analysis on the cardiac risk factors taken from patient     history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the     CTA. We will also conduct basic analysis to support our hypothesis that long term     antiretroviral therapy increases coronary artery disease.      Funding:      The bloodwork and CTA tests ordered in this study will be payed for by insurance companies     where available. In cases where insurance companies will not pay, Florida Heart Center will     pay for the CTA tests and Associates in infectious Disease will fund the bloodwork.      Humans Subjects Protection:      This will be a projective chart review study that will require access to protected health     information. Thus, we will seek full IRB approval from the FSU IRB committee with informed     consent. An informed consent document will be given to each patient explaining all the risks     and benefits of the study in addition to the methods. Recruitment will be done by an office     staff or medical assistant not on the research team. After patient recruitment, their medical     records will be flagged for study and they will undergo the required testing. At completion     of testing, their results will be recorded in the final data sheet, and their medical record     will no longer be flagged for study. No identifying data will be recorded in the final data     sheet, and the data will be stored in an encrypted excel sheet on a secure password protected     personal laptop running antivirus and firewall. Third parties (such as family members) will     not have access to any research data regardless of authorizations received from the study     subjects. All the test results and labwork performed for the study will go into the patient's     individual medical record at their respective offices. Thus, if an authorized third party     wishes to view any test results, they can do so via the normal methods at the doctor's     office.   "
83632|NCT02191293|"     Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)     and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to     Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and     liver enzymes.   "
83633|NCT02191280|"     Study to determine the efficacy and tolerability of two dose levels of Antistax relative to     placebo in patients suffering from CVI grade I or incipient grade II   "
83655|NCT02190994|"     The purpose of this four-arm randomized controlled study is to determine whether eliminating     glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar     lesion could result in similar or better outcomes comparing to traditional replacement     therapy, regarding postoperative recovery of pituitary function and other postoperative     complications (infection, pain, quality of life, recurrence). Surgical patients of our center     with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT)     will be performed for assessment of the pituitary function at enrollment. Patients with     normal pituitary function will be randomized into non-GC replacement group (group A) and     low-dose GC replacement group (group B), while patients with impaired pituitary function will     be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group     (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of     the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The     secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH,     thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance,     infection, recurrence and health-related quality of life.   "
83634|NCT02191267|"     Chronic traumatic encephalopathy (CTE) is a progressive degenerative brain disease with     symptoms that include memory loss, problems with impulse control, and depression that can     lead to suicide. As the disease progresses, it can lead to dementia. Currently CTE can only     be diagnosed postmortem where an over-accumulation of a protein called tau is observed. There     is now a new experimental measure that makes it possible, for the first time, to measure tau     protein in the living human brain using a novel positron emission tomography (PET) ligand,     [F-18] AV-1451 (aka, [18F]-T807).      The main objective of this study is to use a novel PET approach to measure tau accumulation     in the brain. The presence of CTE at autopsy in deceased National Football League (NFL)     players has been well documented. Accordingly, we will conduct this study in a group of     retired NFL players who have clinical symptoms of CTE and are suspected of having CTE based     on high levels of tau in their spinal fluid and abnormalities seen on research brain scans.     We will compare them with a control group of former elite level athletes who have not     experienced any brain trauma, deny any clinical symptoms, and who have completely normal     spinal fluid tau and amyloid levels, and brain scans. We will also include a group of     subjects with AD. All participants will be recruited from ongoing studies, headed by the     Partnering PI of this proposal, Dr. Robert Stern, at the Boston University Center for the     Study of Traumatic Encephalopathy and the Alzheimer's Disease Center. We will use both a beta     amyloid PET scan ([18F]-florbetapir) and a tau PET scan ([18F]-T807) on consecutive days.     With the beta amyloid scan we expect little or no evidence of amyloid in the NFL players with     presumed CTE, and no evidence of amyloid in the control group of athletes with no history of     repetitive brain trauma. In contrast we expect to see beta amyloid accumulation in the AD     patient brains. With the new tau ligand, we expect that the NFL players with presumed CTE     will show elevated levels of tau protein in the brain, which will not be observed in athletes     without a history of brain trauma, but which will be seen in the AD patients' brains.      Another goal is to use the latest MRI technologies to develop specific tau imaging biomarkers     that correlate with the PET and spinal fluid tau measures but without the radiation of PET or     invasiveness of spinal taps. The development of these surrogate imaging markers of tau, is     critically important to diagnosing CTE. This in turn will lead to studies relevant to     treatment and prevention of this devastating disease. Finally, as an exploratory method of     examining possible genetic risk for CTE, we will also use cutting edge genetic analysis of     blood samples from subjects in this proposal and compare tau load, measured by PET tau ligand     uptake and cerebrospinal fluid (CSF) p-tau level, with a measure of genetic susceptibility to     tau load, referred to as the genetic risk score for tau.   "
83635|NCT02191254|"     Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients     with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location,     Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)   "
83636|NCT02191241|"     To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol     glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf     Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this     dose in healthy subjects.   "
83637|NCT02191228|"     The main objective of this study was to assess the effect of normal and impaired renal     function on the safety, pharmacokinetics, and pharmacodynamics of linagliptin following oral     administration of 5 mg daily for 7 days (Groups 1 to 3), 5 mg daily for 10 days (Groups 6 and     7), or as a single dose (Groups 4 and 5)   "
83638|NCT02191215|"     The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of     nevirapine in the management of the HIV/AIDS in an open environment.   "
83639|NCT02191202|"     Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of     life of HIV-positive patients   "
83640|NCT02191189|"     Study to determine the absorption of Nevirapine from different regions of the Gastro     Intestinal tract.   "
83641|NCT02191176|"     The primary objective of the current study is to investigate the safety with special emphasis     on ECG effects, and tolerability of dextromethorphan hydrobromide monohydrate (2mg/mL syrup)     in healthy male and female subjects following oral administration of 30 mg q.i.d. and 90 mg     q.i.d. for 2 days followed by a single morning dose (extensive metabolisers of CYP 2D6) and     for 10 days followed by a single morning dose (poor metabolisers of CYP 2D6).      Additionally pharmacokinetic properties of dextromethorphan and its main metabolites     dextrorphan, 3-hydroxymorphinan, and 3-methoxymorphinan will be investigated   "
83642|NCT02191163|"     Study to determine the efficacy and safety of Antistax® film coated tablets in improving     microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)   "
83643|NCT02191150|"     The study will obtain data to show insight into clinical outcomes of patients switching from     Darbepoetin Alfa to a epoetin alfa biosimilar.   "
83644|NCT02191137|"     The MOTION study is a prospective, Phase IV study, enrolling 61 patients with Pulmonary     Arterial Hypertension (PAH). The study designed to further explore patient-reported outcomes     in PAH subjects who are not on active treatment and living in the United States. In addition,     the study will be exploring the use of new telemetric technology (Accelerator band) to     evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in     patients with PAH   "
83645|NCT02191124|"     In recent years, measurement-based care (MBC) has been gaining more attention in the     treatment of depression because it allows psychiatrists to individualize treatment decisions     for each patient based on the change of psychopathology and tolerance toward antidepressants.     Several studies, such as the Sequenced Treatment Alternatives to Relieve Depression (STAR*D)     trial using MBC, found that MBC-informed sequential algorithms can be successfully integrated     into clinical practice and improve patients' outcomes However, despite a strong theoretical     rationale for MBC and data supporting the ability to implement MBC in clinical practice     settings, there is currently no randomized controlled trial in MDD patients comparing MBC     with usual/standard care. The investigators compare MBC with clinician's treatment decisions,     standardizing care to two commonly prescribed antidepressants.      Therefore, the aim of this study is to determine the effects of MBC in patients with MDD     compared to standard treatment (ST). The research hypothesis is that compared to ST, the     estimated time to response and to remission would be significantly shorter in the MBC group     without increased dropout rates and side effect burden.   "
83668|NCT02190825|"     This study aims to investigate the safety, efficacy, peri and postoperative complications,     and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of     pelvic organ prolapse (POP).      Prolapse staging for all subjects in this study will be performed according to the POP-Q     staging system.      Ultrasound examinations for all subjects in this study are subjected to the surgeon need and     will be performed if required by qualified personnel   "
83669|NCT02190812|"     Use the system to evaluate of wrist muscle strength.   "
83670|NCT02190799|"     Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in     September 2012, more than 800 cases have been reported to the World Health Organization (WHO)     with substantial mortality.   "
83671|NCT02190786|"     The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of     multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.   "
83646|NCT02191111|"     Background: Despite evidence of benefit for pharmacist involvement in chronic disease     management, the provision of these services in community pharmacy has been suboptimal. The     Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests     that for knowledge translation to be effective, there must be evidence of benefit, a context     conducive to implementation, and facilitation to support uptake. We hypothesize that while     the evidence and context components of this framework are satisfied, that uptake into     practice has been insufficient because of a lack of facilitation. This protocol describes the     rationale and methods of a feasibility study to test a facilitated pharmacy practice     intervention based on the PARiHS framework, to assist community pharmacists in increasing the     number of formal and documented medication management services completed for patients with     diabetes, dyslipidemia, and hypertension.      Methods: A cluster-randomized before-after design will compare ten pharmacies from within a     single organization, with the unit of randomization being the pharmacy. Pharmacies will be     randomized to facilitated intervention based on the PARiHS framework or usual practice. The     Alberta Context Tool will be used to establish the context of practice in each pharmacy.     Pharmacies randomized to the intervention will receive task-focused facilitation from an     external facilitator, with the goal of developing alternative team processes to allow the     greater provision of medication management services for patients with diabetes, hypertension,     and dyslipidemia. The primary outcome will be a process evaluation of the needs of community     pharmacies to provide more clinical services, the acceptability and uptake of modifications     made, and the willingness of pharmacies to participate. Secondary outcomes will include the     change in the number of formal and documented medication management services in the     aforementioned chronic conditions provided 6 months before, versus after, the intervention     between the two groups, and identification of feasible quantitative outcomes for evaluating     the effect of the intervention on patient care outcomes.      Results: To date, the study has identified and enrolled the ten pharmacies required and     initiated the intervention process.      Conclusion: This study will be the first to examine the role of facilitation in pharmacy     practice, with the goal of scalable and sustainable practice change.   "
83647|NCT02191098|"     To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of     ALT-803 in HIV   "
83648|NCT02191085|"     Access to medical care for patients with breathing disorders during sleep is a major problem     for Canadians. Recently, there has been increasing interest in how health care providers who     are not physicians can help to improve access to medical care for these patients, but it is     unclear whether patients with severe sleep-disordered breathing who receive care from these     non-physician providers have the same response to treatment as patients who receive care from     physicians. Since these severe have a high risk of developing cardiac and respiratory     complications and of being hospitalized, an initiative to improve access such as the use of     non-physician providers could be of great benefit to individual patients and the health care     system.      The objectives of this project are:        1. to determine whether patients with severe breathing disorders during sleep have the same          response to treatment when cared for by non-physician health care providers (respiratory          therapists) as they do when cared for by physicians;        2. to determine the effects of non-physician health care provider treatment to patient          access;        3. to determine health care utilization and related costs associated with non-physician          health care provider treatment.   "
83649|NCT02191072|"     Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and     phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab     as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous     urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset     of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab     will be effective in the treatment of severe acute urticaria as add on therapy with a fast     onset of action. Objective:To investigate the efficacy and safety of omalizumab in the     treatment of severe acute urticaria Study design: This prospective, interventional,     single-arm open label study will recruit patients with severe acute urticaria from emergency     departments, hospitalized and outpatient departments. The included patients will receive a     single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be     evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline,     1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity     of treatment-emergent adverse events will also be evaluated   "
83650|NCT02191059|"     1. There is as yet no optimal treatment regimen for patients with epidermal growth factor          receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .        2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang          BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the          similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed          icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably,          anti-tumor activities were observed in patients with advanced NSCLC.        3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in          combination with Docetaxel as second-line treatment for NSCLC patients with wild type          EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall          survival(OS) and health related quality of life(HRQoL) will be monitored.   "
83651|NCT02191046|"     The purpose of this study is to the effect of squeezable bottle nasal irrigation device with     syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation   "
83652|NCT02191033|"     This study is a randomized-controlled clinical trial which evaluates the efficacy of     physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in     promoting cigarette smoking in smokers enrolled in college.      The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement     therapy, and text messaging will have higher quit rates that smokers receiving physician     brief advice and nicotine replacement therapy alone.   "
83653|NCT02191020|"     This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial.     Patients with psoriasis vulgaris were randomly divided into the experiment group （treated     with TGP combined with acitretin capsules) and control group （treated with placebo combined     with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were     evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of     treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe     and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.   "
83654|NCT02191007|"     Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol     Ointment in sequential therapy   "
83672|NCT02190773|"     In the present clinical study including chronic, aggressive periodontitis and healthy     individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG),     Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after     surgical periodontal treatment and search out the relationship of clinical parameters with     these cytokine levels.   "
83673|NCT02190760|"     The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the     duration of a block. The aim of this study is to determine whether this a systemic or local     effect.   "
83660|NCT02190929|"     A cross-sectional study design and online questionnaire was used to assess the informational     needs of patients with several different types of systemic vasculitis. Patients were     recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient     Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry     were compared to responses from a similar survey recently administered to patients within a     United Kingdom (UK) based vasculitis support group (Vasculitis UK).   "
83661|NCT02190916|"     The purpose of this study is to learn about how patients with vasculitis think about their     illness and to assess to what extent patient perceptions of illness are associated with     physical, mental, and social functioning   "
83662|NCT02190903|"     This pilot project will address the gaps in knowledge regarding the effect of anesthetic     technique on the risk of delirium through an adequately-powered trial employing standardized     regimens for treatment and outcome assessment to test the hypothesis that use of spinal     versus general anesthesia decreases the risk of delirium after hip fracture surgery.   "
83663|NCT02190890|"     The purpose of this study is to determine the effectiveness of different dry needling dosages     in the treatment of myofascial trigger points in the upper trapezius muscle in patients with     myofascial neck pain.   "
83664|NCT02190877|"     This study is designed to validate ease-of-use for the CoVa Monitoring System, along with     simple statistical parameters such as reproducibility and inter-subject agreement between     test and reference devices.   "
83665|NCT02190864|"     Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences     into clinical treatment planning.   "
83666|NCT02190851|"     Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was     reported at the congress of the Société Interdisciplinaire Francophone d'UroDynamique et de     Pelvi-Perinéologie (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients     with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder.     Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated     with subjective improvement of LUTD assessed with the Patient Global Impression of     Improvement (PGI-I) in 5 of the 6 patients.      In view of the encouraging results of this pilot study, we hypothesize that TENS treatment     may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and     multisystem atrophy (MSA).   "
83667|NCT02190838|"     Treatment of disseminated melanoma is still a difficult issue. Obvious achievements of recent     years proves efficacy of immunologic approachees in this field. The ability of melatonin and     metformin to decrease metabolic immunosuppression was shown in many experimental studies.     Some literature data confirm the possibility of increasing efficacy of melatonin with     dacarbazine (DTIC) and metformin with DTIC combinations. We hypothesized that this     combinations could be more effective than DTIC monotherapy in terms of response rate and time     to progression.   "
85554|NCT02166177|"     'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell     therapy, as adjunct immunosuppressive treatment in the context of liver transplantation   "
83674|NCT02190747|"     Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result     in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life     and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza     infections. Recurrent flare-ups progressively restrict movement by locking joints leading to     cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability     of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO)     following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma     agonist, will prevent HO during and following a flare-up in subjects with FOP.   "
83675|NCT02190734|"     Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this     study is to see if there are immediate changes in pushing behaviors in individuals who have     had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking     overground.      The investigators do not think there will be a change with sitting in the wheelchair, but the     investigators think there may be an improvement in pushing behaviors after walking training.   "
83676|NCT02190721|"     The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and     efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children     and adolescents with solid tumors without bone marrow involvement.   "
83677|NCT02190708|"     Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours)     and is primarily metabolised by CYP3A.      Omeprazole is a selective proton pump inhibitor substrate used to reduce gastric acid     secretion. Omeprazole is primarily metabolised by CYP2C19.      Midazolam and omeprazole are both used as probe drugs in clinical pharmacology studies to     evaluate clinical CYP3A and CYP2C19 drug interactions, respectively. Furthermore the EMA and     the FDA guidance on drug interactions recommend the use of these drugs for such evaluations.      The aim of this study is to assess the effect of PQ912 on the PK of midazolam and omeprazole.     In vitro studies have demonstrated that PQ912 inhibits several CYP enzymes, including CYP3A4     and CYP2C19 and at the expected exposure levels in patients, has the potential to inhibit     these enzymes in-vivo. This study is therefore planned to investigate the potential changes     in the PK of midazolam and omeprazole due to the effect of PQ912 at steady-state. In clinical     practice it is likely that co-administration of PQ912 with other drugs that are metabolised     via the CYP3A and/or CYP2C19 enzymes will occur. This study will provide important     information for the requirement of dose adjustments or contraindications in these     circumstances.   "
83678|NCT02190695|"     The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML),     Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are     used to treat AML and MDS but are not usually combined together. The investigators are     looking at both the safety and Efficacy of each combination.   "
83679|NCT02190682|"     Postoperative Persistent Pain (PPP) is reported with a high incidence in adults 11.5-47%.     This high incidence effects quality of life of patients causes social-economical problems and     arises medico-legal issues. This study will be undertaken for producing a database by the     evaluation of surgeries in 4 hospitals located in Istanbul. This database will be used in     establishing a software by using data mining technology in the prediction of PPP   "
83681|NCT02190656|"     Bowel cancer is the third most common cancer in the UK in both males and females. The rectum     is the most commonly affected part of the bowel. Improvements in surgery have meant that many     patients with rectal cancer can now undergo surgery that removes the rectum and avoids a     permanent stoma. The operation that most patients have is an anterior resection of the     rectum.      Unfortunately this surgery frequently leads to a change in bowel function, with patients     suffering from incontinence, urgency and unpredictability a problem known as anterior     resection syndrome. These problems are believed to be fairly common following surgery but     follow up appointments have traditionally concentrated on ensuring that the cancer has not     returned and have not reviewed functional outcomes in enough detail. Because of this we are     unsure exactly how common the problems described are.      The proposed study will allow us to determine how many patients have ongoing symptoms     following their surgery for rectal cancer. It will also allow us to use a newly developed     scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK     population, to ensure that it can accurately be used in the future to measure the problem and     aid development of new therapies. An appreciation of the impact of symptoms on postoperative     quality of life will encourage routine assessment of functional outcomes in clinical     practice, allowing identification of patients who may benefit from treatment.   "
83682|NCT02190643|"     The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive     smokers focused on improving adherence to using the nicotine skin patch.   "
83683|NCT02190630|"     The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring     following wear of a twin block functional appliance (removable brace which postures the lower     jaw forward to improve a discrepancy between the upper and lower jaw) for differing time     periods.   "
83684|NCT02190617|"     The primary hypothesis the investigators will test is that that improving asthma guideline     implementation and providing patients with a unified asthma management plan using a     multi-component and multilevel intervention will improve patient-centered asthma outcomes     compared to health plan case management, passive guideline dissemination and provider     education.   "
83685|NCT02190604|"     This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary     pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis     patients following single and multiple doses. This first-in-human and proof of concept study     will consist of 4 parts, with Parts 1 and 2 in healthy volunteers and Parts 3 and 4 in cystic     fibrosis patients.   "
83714|NCT02190227|"     The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption     Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast     cancer treated with neoadjuvant chemotherapy.      This is important because the earlier non-responders are identified, the greater is the     impact of reducing side effects of ineffective treatments.      The study hypothesis is that the RDA score will accurately predict for tumor response after     one cycle of chemotherapy.   "
83686|NCT02190591|"     The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after     epidural anesthesia in patients who have never given birth. The study will measure the impact     on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or     forceps use), and third or fourth degree laceration rates. This study will determine the     impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and     one with traditional wedge and pillow positioning. If benefits related to use of the PLB can     be demonstrated, it is our intention that each labor room will be stocked with a PBL for use     as standard of care.      This study will test the following hypotheses:        1. The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal          delivery rate in low risk nulliparous patients who receive epidural anesthesia compared          to similar cohort using traditional wedge and pillow positioning.        2. Using the PLB will impact the amount of time from epidural placement to complete          dilation and the time of second stage of labor, when compared with the control cohort.        3. Use of the PLB will impact the third and fourth degree laceration rates when compared          with the control cohort.   "
83687|NCT02190578|"     To determine the efficacy of an improved rapid diagnostic test using venous whole blood and     fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will     be determined by comparing the results with patient infected status for HIV-1 (human     immunodeficiency virus type 1).      The study will consist of a single one-hour visit, at which time blood samples will be     collected and tested with the investigational device (Reveal G4) and FDA approved comparator     assays for detection of HIV-1 antibodies.   "
83688|NCT02190565|"     The purpose of this study is to determine whether a food supplement consisting of vitamins,     minerals and fish oil taken during and after pregnancy can decrease the need for additional     iron supplementation due to anemia during pregnancy, and optimize levels of nutritional     markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal     blood and breast milk, compared to placebo.   "
83689|NCT02190552|"     A.R.I.S.E. is a post approval observational study using standard care. The purpose of this     study is to collect information about the ability of the EmboTrap device to remove blood     clots from the brain, and the associated performance characteristics and clinical outcomes.     No formal hypothesis testing is needed as no comparisons are planned within the study.     Instead, estimates of each population parameter of interest for all primary and secondary     endpoints will be provided using appropriate confidence intervals.   "
83690|NCT02190539|"     The objective of this study is to conduct a feasibility study at Meir Oncology Institute     examining whether patients with advanced breast cancer would follow a homeopathic protocol     for three to six months.      The primary aim of the study is to establish if patients with advanced breast cancer in Meir     Oncology Institute would follow a regimen of treatment as used by Dr Banerji in India, for     six months.      The secondary aim is to observe the quality of life and wellbeing of patients undergoing this     protocol   "
83728|NCT02190045|"     Falls are a major public health problem. They are the leading cause of injuries and     injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major     reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly.     Despite the many proven benefits of exercise, many older adults in the US remain sedentary.     This study targets at improving balance and gait with use of Wii-Fit as an exercise program.   "
83691|NCT02190526|"     The aim of this study is to evaluate the effects of Mesalamine and Amitriptyline drugs on the     Quality of Life and Symptom Severity Scale in patients with Diarrhea- Predominant Irritable     Bowel Syndrome (IBS-D).      All patients will fill three validated questionnaires (IBS Symptom Severity Scale (IBS-SSS) ,     Hospital Anxiety and Depression Scale (HADS ) and IBS Quality of Life (IBS-QOL) ) at the     beginning of trial and at weeks 2,4,6 and 8 of treatment.      Serum Immune Bio markers will be measured at 0,4, and 8 weeks of treatment. This study is a     clinical trial upon 90 patients with Diarrhea- Predominant IBS (IBS-D) who are referred for     the first time to our private gastrointestinal clinic from 2014 until 2016.      All patients who meet the inclusion criteria enrolled for a 2-week period screening phase. In     order to exclude patients with Lactose intolerance, all patients take a lactose-free diet for     14 days before inclusion and patients whose symptoms improve by this regimen will be     excluded.      This trial is a double-blind study and all patients will be assigned randomly to three     groups:        1. Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to          Amitriptyline (10 mg/HS) for 8 weeks        2. Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol          (800 mg/ TDS) for 8 weeks        3. Control group (placebo group): Patients receive placebo like Asacol (800 mg/TDS) and          placebo similar to Amitriptyline (10 mg/HS) for 8 weeks      Ethical considerations:        1. All patients will fulfill an informed consent        2. Drugs are available without any charge        3. Observation of Helsinki ethical statement   "
83692|NCT02190513|"     Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the     gastrointestinal tract with specific clinico-pathological characteristics. In recent years,     in the literature, several children who underwent upper gastrointestinal endoscopy for     suspected CD, which was confirmed histologically, were also found to have coexistent EE.     There are reports of coexistent CD and EE. We would like to see the prevalence of EE in     children with CD and the prevalence of CD in children with EE in our population, and to do so     would like to review medical records. Our objectives are to determine if children with celiac     disease have a high prevalence of eosinophilic esophagitis.and to determine if children with     eosinophilic esophagitis have increased risk of developing celiac disease.   "
83693|NCT02190500|"     The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and     treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent     transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further     management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS)     to a CSC ED for evaluation and treatment (Standard Management-SM).   "
83708|NCT02190305|"     The purpose of this study is to determine the efficacy of two rapid diagnostic tests in     plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of     Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status     for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV     (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing     the results with patient infected status for HBV.      Subject participation in the study will consist of a single one-hour visit, at which time     blood samples will be drawn for testing with the investigational devices and with approved     comparator assays. The test results, which are the outcome of the study, will be obtained     only once, at the time of this visit.   "
83694|NCT02190487|"     Acute kidney injury (AKI) is one of the most frequently encountered and prognostically     significant complications after cardiovascular surgery. However, there is no definitive     treatment to intervene after development of AKI, therefore, preventive strategy has been the     major issue. By this time, incidence of AKI after cardiovascular surgery has been reported     3-50% based on the studies with various definition of AKI and different patient cohorts.     Development of unified definition for AKI in the early 2000s opened a new era in AKI study.      According to the previous studies, aortic surgery, especially thoracic aortic surgery was     known to be highly prevalent of AKI, which was considered to be caused by use of total     circulatory arrest (TCA), relatively high number of emergency cases, combined malperfusion     syndrome before surgery and relatively complicated surgical procedure. However, there has not     been many studies of AKI in thoracic aortic surgery because of its low incidence and urgent     clinical presentation of aortic pathology, which hinder large randomized controlled study.     Moreover, there are conflicting reports of incidence and risk factors of AKI after thoracic     aortic surgery, no conclusive result has been made. Therefore, this study was designed to     investigate the incidence and risk factors after thoracic aortic surgery only due to     dissection.   "
83695|NCT02190474|"     The primary objective of this study to determine the feasibility and acceptability of a     mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain     and other similar chronic symptoms.   "
83696|NCT02190461|"     Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory     Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted     patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life     related to health (HRQOL).   "
83697|NCT02190448|"     The overall aims of this project are to 1) determine the quality of life effects and safety     of a combination herbal galactagogue tea in lactating women, and 2) measure changes in     maternal blood concentration of oxytocin, prolactin, and milk production. The defined outcome     measures will include quality of life measures and safety parameters in the breastfeeding     woman and basic infant health. If the tea proves safe and effective, then it can provide a     proven all-natural and organic supplement for increasing lactation in women. This in turn     will increase quality of life for both the infant and the mother.   "
83729|NCT02190032|"     The investigators are trying to compare the individually modified-angled tube and the     conventional-angled tube in ease of double lumen endotracheal tube insertion and the     incidence of related postoperative complications.   "
83759|NCT02189642|"     The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care     Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as     intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators     hypothesize quality of PACU outcomes will correlate with preoperative demographic and     behavioral characteristics as well as intraoperative and anesthetic procedures/techniques.     This study will help the investigators improve post anesthetic care quality and create a     higher level of satisfaction for patients, family, and health care providers.   "
83698|NCT02190435|"     There are approximately 250,000 hip fractures in the US every year, and intertrochanteric     (IT) fractures (fractures that occur just below the femoral head) account for nearly half of     these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has     become a well-accepted and increasingly more common procedure among orthopaedic     traumatologists, and is standard of care at our institution.      While advancements in intramedullary nail fixation have made it a relatively efficient     procedure, the placement of the lag screw into the femoral head still remains a challenging     step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most     commonly reported complications with IM nail fixation. Previous work has shown that the lag     screw position is an important factor in reducing screw cut-out. This step of the procedure     can be time demanding and often requires several intraoperative radiographs for accurate     placement. Recently developed computer-assisted navigation systems provide surgeons with the     ability to track screw placement in real-time. This could allow for improved screw placement     and potentially reduce radiation exposure to the patient and surgeon. To date, the potential     advantages of computer-assisted navigation have not been examined.      The primary objective of this study is to examine whether the use of Stryker's ADAPT     computer-assisted navigation for Gamma nail fixation can result in improved lag screw     placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail     fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a     difference in the lag screw placement (i.e. tip to apex distance measurement) between     procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.     Additionally, we hypothesize that there is a difference in radiation exposure (i.e.     fluoroscopy time) between procedures using the ADAPT system versus the conventional technique     for Gamma nail fixation.   "
83699|NCT02190422|"     Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile     couples. However, the long-term effect of ART exposure on cardiovascular development and     potential association with ART procedure and parental factors is confused. The aim is to shed     more light on the pattern and extent of cardiovascular developmental alteration among ART     children and its association with potential confounders.   "
83700|NCT02190409|"     The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF     application on implant osseointegration in the early phase of healing.   "
83701|NCT02190396|"     Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The     role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at     placental pathologies is unknown. Placental calcification is usually thought to be a     physiological aging process. Nevertheless, it can be a pathological change resulting from the     effects of environmental factors on the placenta. The aim of the investigators study was to     evaluate the relationship between placental calcification and maternal and cord blood     25-hydroxyvitamin-D3 [25(OH)D] and calcium concentrations in low-risk obstetric population at     term and their consequences.   "
83702|NCT02190383|"     The main purpose of this study is to evaluate the efficacy of a habit reversal based     treatment programme in children and adolescents aged 8 to 18 years with tic disorders.   "
83703|NCT02190370|"     The main purpose of this study is to evaluate the efficacy of a resources activation based     treatment programme in children and adolescents aged 8 to 18 years with tic disorders.   "
83704|NCT02190357|"     Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and     increased intestinal permeability all leading to an increase in bacterial translocation and     increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral     administration and exhibits broad spectrum antimicrobial activity against both aerobic and     anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.     It has been suggested that oral prophylactic antibiotics or bowel decontamination might     improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore     the effect of rifaximin on the complications of advanced cirrhosis.   "
83705|NCT02190344|"     The objective of this study is to determine the functionality of an eight-channel paddle coil     system which is to be used in future MRI studies.   "
83706|NCT02190331|"     -  To evaluate the effects of a 32-weeks resistance and stretching training program applied          in Physical Education classes on forward head and protracted shoulder Portuguese          adolescents (15-17 years old).        -  To evaluate on adolescents submitted to strength and stretching exercises the effects of          a 16-week detraining period after the end of the intervention protocol.   "
83707|NCT02190318|"     Aldosterone blockade is useful in preserving residual renal function in patients on PD.The     long term efficacy of dual blockade of the RAAS is better than monotherapy.   "
83710|NCT02190279|"     Background:      - Prostate cancer is the second leading cause of cancer deaths in American men. A chemical     called a radiotracer helps doctors get images of this type of cancer. Researchers want to     test a radiotracer called 18F-DCFBC.      Objective:      - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.      Eligibility:      - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have     relapsed, or has spread outside the prostate.      Design:        -  Participants will be screened with physical exam and medical history. They will give a          blood sample.        -  Participants will be divided into three groups.      Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or     biopsy at NIH.      Group 2: people who had their prostate removed or had radiation therapy and now have a rising     prostate-specific antigen (PSA) without other signs of disease.      Group 3: people whose cancer has spread to other areas of the body.        -  Participants will have 18F-DCFBC injected into a vein then imaged in a PET/CT camera.          During the scans, they will lie on their back on the scanner table.        -  Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the          rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a          contrast agent injected through an intravenous line.        -  Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21          days of the 18F-DCFBC scan to look for prostate cancer in the bone.        -  Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.        -  A few days after each scan, participants will be contacted for follow-up.   "
83730|NCT02190019|"     Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of     motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance     of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic     Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of     refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients     with apathy, rTMS to the frontal lobe might be helpful in treating the same. Study hypotheses     include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and     executive function better than sham treatment in those with MCI   "
83760|NCT02189629|"     Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of     treatment on the face and trunk for acne vulgaris.   "
83711|NCT02190266|"     Background:      - Coccidioidomycosis is caused by a fungus that grows in the southwest United States and     parts of Mexico and South America. This disease is caused by breathing dust containing the     fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can infect     other body parts. This is called disseminated coccidioidomycosis (DCM). If the fungus stays     in the lungs for more than 6 months, it is called refractory coccidioidomycosis (RCM). People     with DCM or RCM may have difficulty fighting off infection because of immune system problems.     Researchers want to study the immune systems of people with DCM or RCM, to learn more about     the disease and the best ways to treat it. They also want to learn more about the types of     people that get DCM or RCM and about the fungus that causes it.      Objectives:      - To learn more about DCM and RCM, the fungus that causes these diseases, and the people who     get them.      Eligibility:      - People over age 2 with DCM or RCM.      Design:        -  Participants will be screened with a review of their medical records.        -  At the initial visit, participants will have:        -  Medical history and physical exam        -  Blood and urine tests. Some blood may be used for genetic testing. The samples will not          include participants names. Participants will be notified only if the tests show          something urgent about their DCM/RCM. Researchers think this sort of problem will be          rare.        -  Questionnaire about their DCM/RCM        -  Sputum (mucus) collection. They will spit into a cup.        -  Participants will have 1 follow-up visit per year for up to 5 years. They will have          blood tests. They may have other procedures to treat their DCM/RCM.   "
83712|NCT02190253|"     Background:      - The hepatitis E virus causes an acute hepatitis that usually goes away by itself.     Researchers in France studied people who received a liver or kidney transplant. They found     that hepatitis E may not go away by itself in these people. It becomes chronic. This can     cause serious liver disease. More than half the people who had organ transplant who had     hepatitis E seemed to get a chronic infection.      Researchers want to find out if hepatitis E happens this often in patients who have liver,     kidney, or small bowel transplants in the United States. If it does, they want to know why.     They want to know if chronic hepatitis E will become an important medical problem. This     research might help improve care for people who have a transplant. It also might help     researchers prevent the spread of hepatitis E.      Objective:      - To see how many patients who have received or are waiting for certain transplants have     antibodies to hepatitis E virus.      Eligibility:      - Adults over age 18 who have had a liver, kidney, liver and kidney, or small bowel     transplant, or are on a waiting list for one.      Design:        -  Participants will be enrolled from 3 transplant centers.        -  Participants will complete a questionnaire. They will be asked about possible risk          factors for hepatitis E exposure.        -  Participants will have a blood sample drawn through a needle placed in a vein.   "
83713|NCT02190240|"     The proposed study has 3 aims: 1) quantitatively describe a model for delivering     complementary and alternative medicine (CAM) therapies to understand the selection of     patients and CAM therapies used for pain management, 2) examine the effects of selected CAM     therapies on immediate change in pain, and 3) examine the effects of selected CAM therapies     on duration of pain change.      Positive results from this study will assist hospitals in the integration of usual care and     CAM therapy for pain reduction. Findings may also drive future research on the cost     effectiveness of these therapies for pain management, as well as the impact on patient     outcomes such as length of stay and use of narcotics.   "
92409|NCT02076529|"     This study is designted to know optimal dose of Ramosteron to control for chemotherapy     induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and     clinilcal parameters using Rhodes Index.   "
83715|NCT02190214|"     This will be a population based study looking at the prevalence of thyroid disorders in     Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its     association with different ethnicity and iodine status. The study will also look at genetic     susceptibility for autoimmune thyroid disorders in the Malaysian population      General hypotheses:      The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for     hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population     There are different susceptibility gene for autoimmune thyroid disorder in different     ethnicity in our population   "
83716|NCT02190201|"     The investigators previous study showed that McGrath Series 5 videolaryngoscope is an     alternative tool for double-lumen tube intubation. But it is not determined about the     advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube     intubation, compared with traditional Macintosh laryngoscope.   "
83717|NCT02190188|"     Research on the implications of orthotic devices and the recovery after knee arthroscopy are     widely known. But only a handful of specific issues have been studied to date. However, the     effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To     our best knowledge, there are no studies that deal with the treatment of partial medial or     lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this     study is to find out if using wedge inserts or knee orthoses improve the outcomes after     partial meniscectomy.      We therefore verify the following hypothesis: In patients with partial meniscectomy can be by     the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a     significantly better clinical outcome than without specific treatment.   "
83718|NCT02190175|"     This is a multicentre non interventional observational study with the objective to follow up     patients with atrial fibrillation who based on current indications are treated with per os     flecainide , for cardiac pulse maintenance.   "
83742|NCT02189863|"     The overall objective of this study is to compare the effect on simulated driving performance     of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.   "
83743|NCT02189850|"     The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a     bowel preparation prior to colonoscopy in pediatric patients.   "
83744|NCT02189837|"     This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of     evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.   "
83745|NCT02189824|"     A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells     (microtransplantation) following consolidation chemotherapy in patients with AML that are not     suitable for allogenic stem cell transplantation.   "
83719|NCT02190162|"     The purpose of this study is to assess the effects of Tantum Verde® for improving recovery     following tonsillectomy Study design: A prospective double-blined randomized trial. Sample     size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth     wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be     treated with a placebo.      The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the     Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for     tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign     the inform consent in one of two places: in the departments before the surgery or in the     clinic in the visit before the surgery. The patients will be evaluated for their ability to     gargle and spit water before the surgery, after which they will be assigned to either the     treatment group who will get a solution of Tantum Verde or the control group who will receive     saline with mint flavor, both in identicle bottles. Randomization will be done using a random     number generator program.      The patients will be asked to gargle and spit the solution they received three times a day     for 30 seconds, for the following week after surgery.   "
83720|NCT02190149|"     This 6-month prospective outcomes study addresses the association between timing of infusion,     patient activity levels, and bleeding episodes through patient-reported measurements.   "
83721|NCT02190136|"     Stretching and flexibility exercise such as yoga and functional resistance exercise are two     forms of exercise that are growing in popularity. However, they have not been scientifically     tested to demonstrate their ability to improve body composition, fitness, heart and metabolic     health, and mood state in overweight/obese women. The investigators hypothesize that during     an 11 week intervention, both forms of exercise will improve body composition, heart and     metabolic health and mood state.   "
83722|NCT02190123|"     REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients     treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital     after an acute coronary syndrome (ACS) event, to be conducted in Belgium and Luxembourg.      Primary objective is to evaluate the actual treatment persistence with oral antiplatelets     (OAP) after an ACS in the clinical practice in Belgium and Luxembourg.      The main secondary objectives are to describe the most frequent reasons for OAP treatment     switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment     changes and to characterize the patient profile in terms of demographics, diagnosis,     management strategies, comorbidities and concomitant medications to identify any association     between patient profile and treatment duration.   "
83723|NCT02190110|"     Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope,     shock/hypotension, or cardiac arrest. Discriminating patients in different categories of     pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The     most frequently used clinical prediction rule is the Wells score (PE likely > 4 points and     PE unlikely ≤ 4 points). PE can be safely ruled out in patients with a PE unlikely     associated with a negative d-dimer test result. Conversely, patients with PE likely or     positive d-dimer level should undergo further diagnostic testing, like multidetector computed     tomography pulmonary angiography (MCTPA).      Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as     an extension of physical examination and have a high specificity. The aim of this study is to     evaluate if the combination of clinical data reported in the Wells score and US data obtained     from vein and lung US (US Wells score) has a better diagnostic accuracy compared to     traditional Wells score.      In adult patients suspected of PE traditional Wells score will be calculated and vein and     lung US (multiorgan US) will be performed in all patients and and US Wells score calculated.     The US Wells score differs from the traditional Wells score in the following items: signs     and symptoms of DVT, replaced by vein US showing DVT, and alternative diagnosis less     likely than PE replaced by alternative diagnosis less likely than PE after multiorgan US.     This latter item is considered positive if at least one subpleural infarct is detected at     lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis     like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms of     presentation. If no findings are detected at lung US, the points for the item remain the same     assigned by traditional Wells score. Final diagnosis of PE will be preferentially established     by MCTPA and in patients discharged without a second level imaging test because of negative     Wells or d-dimer, and patients with not conclusive second level diagnostic test, will enter     the 3 months follow-up protocol.      The diagnostic performance of traditional and US Wells scores will be assessed by calculating     sensitivity, specificity, positive, and negative predictive value, and likelihood ratios.     Failure rate and efficacy of d-dimer in patients stratified as PE likely and PE unlikely     will also be calculated.   "
83736|NCT02189941|"     The purpose of this study was to evaluate the pharmacokinetic and safety profile of the     sustained-release formulation of deferiprone under both fasting and fed conditions, and     evaluate the relative bioavailability of this sustained-release formulation when compared to     immediate-release formulation of deferiprone under fasting conditions.   "
83781|NCT02189356|"     The aim of this study was to evaluate the effect of exercise programs on pregnant women with     pregnancy-related Low Back and Pelvic Pain (LBPP). Hypotheses of the study were: 1) Exercise     programs relieve the intensity of LBPP in pregnant women and 2) Exercise programs promote     functional capacity for pregnant women with LBPP.   "
83724|NCT02190097|"     Polycystic ovary syndrome (PCOS) is a syndrome which includes elevated androgen levels,     irregular menstrual cycles and insulin resistance. Standard treatments, which include weight     loss and medications to improve insulin secretion are only partly successful, and may require     that young women take medications for decades.      The study investigators have been evaluating the effects of specific diets on insulin     resistance in healthy volunteers and subjects with type 2 diabetes, and have found that     subjects with insulin resistance seem to respond particularly well to these diet regimens.      Volunteers with PCOS are being asked to participate to see if following these diets can help     regularize your menstrual cycles. The results of this study may help improve fertility     treatments for women with PCOS.   "
83725|NCT02190084|"     Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of     motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain     and loss of dopamine, a type of neurochemical, in this part of brain results in apathy.     Presence of apathy is linked to deficits in planning sequential tasks such as keeping a     routine. Patients with apathy have poor physical function and their caregivers experience     extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved     the use of brain stimulation by a magnet known as repetitive transcranial magnetic     stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to     frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in     AD. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will     improve apathy and executive function better than sham treatment in those with AD.   "
83726|NCT02190071|"     The purpose of this study is to determine whether there is a difference of diagnostic     accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients     who were previously suspected of pancreatic cancer in radiologic test.   "
83731|NCT02190006|"     Our study is observational, we are observing data from routine measurements during IVF/ICSI.     Our study does not assess IVF/ICSI as an intervention, we are evaluating the role of FSI and     preovulatory count which are calculated by observing routine measurements during the IVF/ICSI     procedure.      300 women with polycystic ovarian syndrome (PCOS) who are decided to be treated with ICSI.     will be subjected to full history taking and clinical examination. On the second day of     menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral     follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined     as the number of follicles measuring 3-10mm.      All patients will have standard pituitary down-regulation followed by follicle stimulating     hormone (FSH) stimulation until the day of Human chorionic gonadotrophin (HCG)     administration.      On the day of HCG administration, ovarian ultrasound scan will be performed using a     transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is     defined as number of follicles measuring≥16mm. Follicular output rate (FORT) will be     calculated as: (FSI =PFC*10000/AFC*Total dose of FSH).      FORT correlation to pregnancy will be compared to that of the preovulatory count number   "
83732|NCT02189993|"     The purpose of this study is to determine what the long term survival is after in hospital     use of total parenteral nutrition due to intestinal failure.      Earlier studies only followed patients for a maximum of 6 months or included only very     specific patients. We were interested in all patients in our hospital and followed them for     up to 2 years.   "
83733|NCT02189980|"     The purpose of this follow up study is to determine the duration of action regarding     aromatherapy to treat nausea occurring postoperatively.   "
83734|NCT02189967|"     In this randomized multicentric phase II study it will be investigated whether an accelerated     postoperative radiotherapy (7 fractions per week, 2 Gy single dose) may improve locoregional     tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional     fractionation (5 fractions per week, 2 Gy single dose).   "
83735|NCT02189954|"     Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal     morbidity linked to laryngeal mask use is related to correct choice of mask size, placement     technique, placement of the laryngeal mask in the correct position on the larynx, cuff volume     and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below 45 mmHg     (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to laryngeal     mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after Laryngeal     Mask Unique placement to limit pressure within the cuff can reduce this morbidity by nearly     70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a certain age     group and cover stages including very young and middle-aged groups. In the literature only     one similar study on the geriatric age group was found.      The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group     with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal Mask     cuff inflated without reference to pressure in the geriatric age group with indications for     Laryngeal Mask Unique placement.   "
83737|NCT02189928|"     Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first     cause of acquired disability, and the 2nd cause of dementia and death. The only approved     treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose     objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few     patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is     mainly correlated to the final infarct size. The objective of neuroprotective treatments is     to reduce the final size of the cerebral infarction.      The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral     ischemia by reducing the final size of cerebral infarction animal models. The per-CID     corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member     with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized     control trial involving 250 patients within 6 first hours of myocardial infarction and     candidate for primary angioplasty.   "
83738|NCT02189915|"     Study Purposes and Objectives:      The objectives should be stated in such a way that the reader can determine the     appropriateness of the study design. If appropriate, state the specific hypotheses being     tested and/or study aims. Use lay language.      Methamphetamine use is of great concern in the state of Utah because it's the primary drug of     threat in the state, and is the primary drug of choice among females between the ages of 18     and 24. The primary hypothesis of the study is that eight weeks of oral creatine     supplementation will result in improvements in depression rating scores in female MA users.     Secondary hypotheses include the following: 1) creatine supplementation will result in a     decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase     after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal     lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral     supplementation.   "
83739|NCT02189902|"     The goal is to determine the vit D supplementation dose that safely results in optimal serum     vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do     this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol     (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living     in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D     concentrations and efficacy to replete vit D status as determined by achieving a minimum     serum 25D concentration of 32 ng/mL (80 nmol/L).   "
83740|NCT02189889|"     Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major     health problem for patients having heart surgery. Hemoglobin is the part of our blood that     carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery,     called preoperative anemia, is a risk factor for an increased chance of morbidity (illness)     and/or mortality (death) after heart surgery. It is also an important indicator of blood     transfusion necessity. Recent clinical research investigations done to study preoperative     anemia suggest a blood transfusion can damage the immune system (the system that protects us     from disease) which can lead to infection, organ dysfunction (especially of the heart,     kidney, brain), prolonged hospital stays, as well as increased supplies, resources and cost     in surgical patients. Comprehensive anemia management can reduce or eliminate the need for     blood transfusions and provide better outcomes after surgery. Therefore, controlling anemia     before surgery is extremely important, and could be a lifesaving measure.      This pilot, feasibility study is being done for several reasons. First of all, it will test     the the safety and effectiveness of using a short-course of two medications, erythropoietin     (EPO) and Feraheme (iron given intravenously [IV]), to increase hemoglobin levels in order to     improve preoperative anemia, reduce transfusions and lower postoperative complications in     anemic patients undergoing heart surgery. Secondly, findings will be used to design a large     randomized controlled trial (RCT). The RCT will establish a protocol to actively manage     anemia before surgery, thus reducing transfusions during surgery and improving recovery     afterwards. It will also help identify valuable information regarding what needs to be done     for timely completion of the planned RCT.      EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia     in patients with certain conditions in order to reduce blood transfusions. And although     approved for use during surgery, it has not been FDA approved for use in cardiac (heart) or     vascular (blood vessels, including veins and arteries) surgery. Common side effects include     nausea, vomiting, itching, headache, injection site pain, chills, deep vein thrombosis (blood     clot), cough, and changes in blood pressure (BP). Feraheme is an iron replacement product     approved for the treatment of low iron anemia in adult patients. It may cause serious     allergic reactions, including anaphylaxis (severe, whole body allergic reaction), as well as     low BP and excessive iron storage.      Patients meeting all eligibility requirements that consent to participate will be randomized     into the study. Randomization is being placed by chance (like a flip of a coin) into one of     two study groups, the treatment group or the control group. There is an equal chance of being     placed into either group, which will be done by a computer.        1. The Treatment Group will receive a 300 unit (U) per kilogram (kg) injection of EPO and a          510 milligram (mg) IV infusion of Feraheme 7-28 days before the day of surgery. And          again 1-7 days before the day of surgery, a second dose of both of these medications          will be given. The third dose, of EPO only, will be administered 2 days after surgery.          Before initiating a dose or giving a subsequent dose, laboratory parameters will be          measured to assess the hemoglobin level and response to the medication. If blood values          increase too rapidly or are too high, the meds will not be started or, if already dosed,          they will not be given again.        2. The Control Group will receive no preoperative intervention for anemia unless lab          results show iron deficiency anemia. The control group will be screened for the presence          of iron deficiency anemia by evaluating blood laboratory values drawn during the          baseline or preoperative visit. If lab results indicate iron deficiency anemia,          over-the-counter oral iron will be recommended, to take until the day of surgery. In          doing so, patients may benefit by potentially reducing the need for blood transfusions.      Data will be collected from all participants from the preoperative visits throughout the     admission, including lab results, medications, vital signs, information about the procedure,     transfusions, and any problems or adverse events.   "
83741|NCT02189876|"     The FemAALES Project is a community collaborative two-arm intervention designed to prevent     HIV (human immunodeficiency) and STD (sexually transmitted disease) infection and     transmission among African American women and men by reducing sexual risk factors and     enhancing sexual negotiation skills. The team of investigators is a collaboration of     researchers and community service providers who are committed to developing prevention     interventions that employ holistic and culturally relevant approaches. This includes     recognizing the impact of forces such as racism, sexism, and gender expectations on     individual behavior and relationship dynamics in African American communities. Specifically,     the investigators hypothesis is that compared to the control condition the FemAALES     intervention arm will reduce risky sexual behavior and STI (sexually transmitted infection)     incidence and will increase condom self-efficacy and risk behavior communication with sexual     partners.   "
83746|NCT02189811|"     Poliomyelitis eradication has entered its last phase with only three remaining endemic     countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since     1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio     resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and     reported from several areas with low population immunity to polio, including in Pakistan.     This study will provide data to National Immunization Authorities in order to make strategic     decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV     switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.   "
83747|NCT02189798|"     The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing     sensitivity can be preserved in newly implanted adults with partial deafness (considerable     low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural     hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™     Mid-Scala electrode to support the development of electro-acoustic stimulation technology     (EAS).   "
83748|NCT02189785|"     This project hypothesizes that the brain's opioid system determines rejection sensitivity, a     personality trait that is a vulnerability factor and feature of several psychiatric     disorders. This project will use positron emission tomography to measure the brain's opioid     response to social rejection and acceptance in a nonclinical population with varying levels     of rejection sensitivity. The results will provide the first major step towards understanding     a neurotransmitter mechanism for rejection sensitivity, allowing for further investigation     into predicting and treating its associated disorders.   "
83749|NCT02189772|"     The purpose of this study is to evaluate the safety and tolerability of a single     administration of Metadoxine Extended Release (MDX) formulation for the treatment of     adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will     also try to evaluate the efficacy of MDX and its level in the blood.   "
83750|NCT02189759|"     The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination     with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia     (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in term infants (greater than or     equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.   "
83751|NCT02189746|"     The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination     with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia     (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7 weeks     of gestational age) when compared with routine WHO thermoregulation alone.   "
83752|NCT02189733|"     The primary objective of the study is to evaluate the pharmacokinetic characteristics and     demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for     subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference     liquid formulation of caplacizumab.      The secondary objective of the study is to compare the safety and tolerability, and the     pharmacodynamic parameters of the new formulation with those of the reference formulation.   "
83753|NCT02189720|"     The primary objective of the study is:      • To provide patients with LEMS/CMS/downbeat nystagmus access to amifampridine phosphate     therapy until the product becomes commercially available.      The secondary objective of the study is:      • To assess the long-term safety of amifampridine phosphate in patients with     LEMS/CMS/downbeat nystagmus   "
83754|NCT02189707|"     To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal     symptoms in adults with constipation.   "
83755|NCT02189694|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would     regulate glucose levels through the infusion of two hormone: insulin and glucagon.      The main objective of this project is to compare the efficacy of single-hormone closed-loop     strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose     levels in children with type 1 diabetes in a diabetes camp.      The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent     in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop     strategy, which in turn is more effective than the conventional pump therapy to reduce time     spent in hypoglycemia   "
83756|NCT02189681|"     Spinal anesthesia is widely performed using a surface landmark based 'blind' technique.     Multiple passes and attempts while administering spinal anesthesia are associated with a     greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma.      Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the     success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia     has to date been limited to case series and case reports.Its use may be limited by the     requirement for wide bore needles and the technical difficulties associated with simultaneous     ultrasound scanning and needle advancement. The use of pre-procedural ultrasound has been     shown to increase the first pass success rate for spinal anesthesia only in patients with     difficult surface anatomic landmarks. No technique has been shown to improve the success rate     of dural puncture when applied routinely to all patients. Routine use of pre-procedure     ultrasound guided paramedian approach results in 50% reduction in number of passes required     for spinal anaesthetic, from a study at Cork University Hospital (awaiting publication).     L5-S1 is the widest interlaminar space and provides minimal contribution to overall movement     of lumbar spine.This interspinous space might still be accessible even if the patient has     minimal spine flexion. We also noted that spinal needle insertion via the L5-S1 interspace     was associated with the fewest passes in the pre-procedure guided ultrasound group (although     non-significant).      We hypothesise that the routine use of pre-procedural ultrasound-guided paramedian spinal     technique at L5S1 interspinous space will result in fewer needle passes to enter the     subarachnoid space when compared to the conventional landmark based midline approach.   "
83757|NCT02189668|"     To determine if non-operative management with antibiotics alone is a feasible treatment     alternative for pediatric patients with uncomplicated acute appendicitis with an     appendicolith identified on imaging.   "
83758|NCT02189655|"     This prospective randomized double-blinded study was conducted to compare the antishivering     effects of two different types of intrathecal administration.   "
83761|NCT02189616|"     Asthma is the disease being studied. The main objective of this study is to assess the     clinical efficacy of mobile phone short message service (SMS) reminder and consultation on     the self-management and outcomes of poorly controlled asthma which is first diagnosed in a     time period of 3 months. The secondary objective is to explore the cost-benefit and     cost-effectiveness of the proposed intervention.      Aims: The main aim of this study is to assist asthma patients to practice asthma     self-management at home by sending reminders and responding to patients' consultations with     mobile phone short message service (SMS), which will eventually help them to control their     asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to     improve patient health outcome via enhancing patient-physician interaction through mobile     phone short message service (SMS) that is low-cost and could be followed easily by the     patients and their physicians.      The hypothesis is that asthma patients who receive weekly text message reminders to educate     them and reinforce adherence will have better asthma outcome, such as asthma control, while     the intervention integrating patient consultation and reminders by SMS improve asthma outcome     even more. The investigators further hypothesize that these subjects under intervention will     have an improvement in secondary measures including quality of life and patient satisfaction.     The investigators also anticipate that such an approach in asthma management will be     cost-effective.   "
83762|NCT02189603|"     The purpose of this study is to determine the safety and immunogenicity of the recombinant     hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E     vaccine in this population.   "
83765|NCT02189564|"     The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is     investigated in a single blinded parallel group design. Reward consists of performance     dependent monetary reward, or of knowledge of performance in selected (above average) trials.      The investigators hypothesize improved motor skill learning and higher involvement of the     dopaminsrgic system under rewarding vs. non-rewarding conditions.   "
83766|NCT02189551|"     The objective of the study is to compare a new medical devices with an established medical     device for lower limb rehabilitation regarding training outcome and patient comfort / patient     satisfaction (primary objective) and treatment effect (exploratory objective).      Primary study endpoints will be a significantly higher rated patient comfort and or patient     satisfaction using the new versions, compared with the established Lokomat. Furthermore,     muscle activity and kinematic movement patterns will be expected to show more involved muscle     groups and a walking pattern involving more degrees of freedom during use of the new version     compared with the established Lokomat.      Exploratory endpoints will be a significantly stronger involvement of muscles needed for     balance, more physiological walking patterns and more change on the lateral positioning of     the feet due to training with the new version, compared with the established Lokomat.   "
83767|NCT02189538|"     Studies have shown that burn patients may benefit from low fat diets, but there is still no     strong data regarding the impact of fatty acid composition used for feeding. The trial test     the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome.     Prospective randomised controlled trial in adult patients admitted for burns > 15% body     surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral     nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular     enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study     endpoints: mechanical ventilation time, inflammation (CRP), infectious and other     complications, mortality until discharge.      The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2)     the study completed with information from the preliminary phase, both phases being randomised     and controlled.   "
83768|NCT02189525|"     The purpose of this study is to evaluate blood-based biomarkers before and after     sports-induced concussion using neuroimaging and head impact sensor technology.   "
83769|NCT02189512|"     The aim of this study is to study the impact of brain death and surgical small bowel     manipulation on the release of different types of monocytes.   "
83770|NCT02189499|"     The purpose of this study is to evaluate the safety and feasibility of a new coronary artery     stent for treating blockages in the arteries supplying blood to the heart muscle. The     Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the     treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over     time, leaving no permanent implant after the blood vessel has healed. This study will will be     the first evaluation of this stent in humans.   "
83771|NCT02189486|"     Research repository designed to establish prostate cancer upgrading reference set and     development of a risk prediction tool. Repository will include clinical information and     biologics on a cohort of 600 men, to predict presence of high grade cancer at time of     prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time     of biopsy.   "
83772|NCT02189473|"     The primary aim of this randomized multi-center trial is to investigate the efficacy of the     radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in     patients with metastatic epidural spinal cord compression.   "
83773|NCT02189460|"     The purpose of this study is to understand the effect of age on language abilities. The     investigators aim at investigating the cerebral modifications that take place in normal     aging, at the functional an anatomical level.   "
83774|NCT02189447|"     Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking     in patients with keratoconus   "
83775|NCT02189434|"     Serum procalcitonin levels will be considerably higher, for a longer period of time, in     patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated     post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier     diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU     methods.   "
83776|NCT02189421|"     The aim of this study is to evaluate the usefulness of a newly developed multibending     ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without     assisting accessory in comparison with conventional ultra-slim endoscope. The investigators     expect that multibending endoscope will show more higher successful performance than     conventional endoscope.   "
86007|NCT02160249|"     The purpose of this study is to determine whether community-based rehabilitation plus     facility-based care is superior to facility-based care alone in reducing disability related     to schizophrenia in rural Ethiopia.   "
83777|NCT02189408|"     The purpose of this study is to investigate reduction of pain, gain of function and     improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during     knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized-     controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months     and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.   "
83778|NCT02189395|"     The goal of the current study is to determine difference in glycemic control between     traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs     basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly     encountered in the investigators county hospital setting which include newly diagnosed type 2     patients and patients on relatively high dose of insulin (dose >0.4 units/kg body weight.     Primary outcome of the study is to determine differences in glycemic control between     treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure     number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.   "
83779|NCT02189382|"     This study will compare the safety and effectiveness of a potassium oxalate desensitizer or     negative control on dentinal hypersensitivity.   "
83780|NCT02189369|"     This clinical validation study is being carried out to validate the efficacy of a test     measuring the clinical application of prostaglandins present in the endometrial fluid in     patients, 24 hours before the embryonic transfer. This test is capable of predicting     endometrial receptivity without the need of performing a biopsy.   "
83782|NCT02189343|"     To determine the maximum tolerated dose (MTD), if present, and dose schedule of ACY-1215     (ricolinostat) in combination with pomalidomide and low-dose dexamethasone in patients with     relapsed-and-refractory multiple myeloma.   "
83783|NCT02189330|"     All subjects in this study will be given tafamidis. After swallowing a single pill of     tafamidis, measurements including blood samples will be compared to see if tafamidis made in     different ways is about the same. After approximately 28 days subjects will be given another     pill of tafamidis and the study measurements will be repeated.   "
83784|NCT02189317|"     This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine     Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps     tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes.     Patients will be randomized into treatment and control arms. The treatment arm will include     40 patients receiving liposomal bupivacaine intra-operatively in addition to the current     standard pain control regimen. The control group will include 40 patients receiving the     standard post-operative pain control regimen. Patients will be assessed to identify     differences in post-operative pain, satisfaction, as well as concomitant pain medication use.     Post-operative range of motion will also be assessed.   "
83785|NCT02189304|"     This is a single-center, Phase I, healthy adult subject study with a randomized, double     blind, three period, three-treatment, cross-over design.   "
83786|NCT02189291|"     Objectives      The objective of this study is to help identify the best practice regarding the use of     indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a     randomized controlled trial comparing the immediate removal of indwelling urethral catheter,     after minimally invasive sacrocolpopexy, to the present standard catheter removal on post     operative day one. Evidence based catheter management will be helpful to both providers and     patients in post-operative decision making.      Specific Aims      Aim 1: To demonstrate that immediate removal of catheter after minimally invasive     sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.      Aim 2: To demonstrate that immediate removal of catheter after minimally invasive     sacrocolpopexy confers no increased risk of re-catheterization.      Aim 3: To demonstrate that immediate removal of catheter after minimally invasive     sacrocolpopexy decreases the occurrence of urinary tract infection.      Design      A randomized controlled trial comparing the standard overnight indwelling urethral     catheterization with removal of catheter immediately post surgery after minimally invasive     sacrocolpopexy, at Oregon Health & Science University.      Outcome measures      Primary outcome measures are hospital stay in hours after completion of surgery and need for     re-catheterization. Hospital stay will be counted from the time the patient leaves the     operating room to the time she leaves the hospital. To avoid confounding, investigators are     only including the first / morning case of the day. For re-catheterization, investigators     will evaluate if patient was able to void after completion of surgery. Investigators will     compare the post voiding residuals, the need for re-catheterizations and the numbers of     patients going home with an indwelling catheter between the two groups. Investigators will     also compare the number of urinary tract infections, as documented by urine culture and     subsequent treatment, between the two groups.      Study Subjects      Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be     invited to participate in the study during their preoperative visit. If they agree to     participation, this will be noted in their chart. Randomization to group will occur     immediately following surgery.   "
83788|NCT02189265|"     The purpose of this study is to investigate whether there has been a change in perinatal     outcomes following the phased smoking ban introduction (January 2004 for workplaces; July     2008 for bars and restaurants) workplaces in the Netherlands.   "
83789|NCT02189252|"     This is a randomized, open-label crossover study. The primary objective of this study is to     compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid     (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a     single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.   "
83790|NCT02189239|"     The objective of the STRESS trial is to investigate in a mode of action setting the effect of     Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute     stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller     Entspannung will be obtained.      A third arm including no treatment is tested as well. Approximately 72 healthy volunteers     will be included into this randomized, double blind study. Study duration will be 7 days,     study medication intake will be over 4 days: participants will take the medication one tablet     three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two     tablets will be taken (morning and midday).   "
83791|NCT02189226|"     The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser     endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of     early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).   "
83792|NCT02189213|"     1 out of 8 children, adolescents, and young adults suffer from an anxiety disorder. Studies     over the past decade show that selective serotonin-reuptake inhibitors (SSRIs), a class of     medication that treats anxiety in adults, also works well in young adults, children, and     adolescents with anxiety disorders, but only for about 50%. 50% will have undergone treatment     for several months before it will be established that the medication is not working to treat     the anxiety. The purpose of this study is to find a test that will predict treatment outcome     from the beginning based on behavioral and biological measures.   "
83803|NCT02189070|"     The purpose of this study is to determine the preference of patients regarding the approach     for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that     patients prefer questionnaires for annual follow-up assessment when compared to telephone or     email.   "
83793|NCT02189200|"     Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic     and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse     events with statins, added to recent questions about their benefits on hard outcomes, opens a     gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in     patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary     fibers with supposed action in reducing the absorption of exogenous cholesterol and the     endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with     alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of     atherosclerotic disease.   "
83794|NCT02189187|"     The goal of this project is to characterize changes in emotion regulation pathways associated     with healthy behaviors in people who have recently lost weight and are seeking to maintain     weight loss over a 1-year period.   "
83795|NCT02189174|"     To estimate the maximum tolerated dose (MTD) or recommended dose for phase II (RP2D) of     CLR457 and to investigate the anti-tumor activity of CLR457   "
83796|NCT02189161|"     Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency     ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).     Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA     will be applied using the Barrx™ Ablation System.   "
83797|NCT02189148|"     Preeclampsia is a complication of pregnancy related to adverse maternal and neonatal     outcomes, including fetal growth restriction and perinatal death. Several measures are used     or under investigation (low-dose aspirin, low-molecular weight heparin, calcium, folic acid,     among others) for the prevention of preeclampsia. Unfortunately, most high-risk women who     could benefit from those preventive measures are not identified until late in pregnancy.     Recent evidences suggest that the investigators could identify women at risk of developing     preeclampsia using a combination of serum and ultrasound biomarkers in the first-trimester of     pregnancy. This screening test needs external validation. A first-trimester screening     strategy will strengthen clinical research on preeclampsia and will contribute to the     development of strategy combining the prediction and prevention of the disease and its     related complications.   "
83798|NCT02189135|"     Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of     illness, disability, and death in Malaysia with an increasing prevalence. Despite the best     effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2     diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk     of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM     Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at     sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will     generally consume large quantities of fried and sugary foods when they break their fast or     during the night. Given the importance and public health significance of poor diabetes     management and its associated risk especially during Ramadan, the investigators aim to test     the intervention of using remote monitoring within community provider practice for patients     with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer     which can directly feedback the patients glycaemic levels to the physicians will reduce and     even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain     euglycaemic throughout the whole Ramadan month.   "
83799|NCT02189122|"     The investigators will compare the effects of rapid release aspirin and NHP-544C on the     prostacyclin response to intravenous bradykinin.   "
83800|NCT02189109|"     This clinical trial is testing the safety, tolerability and effectiveness of NVX-108     administered via intravenous infusion in combination with standard radiation and     chemotherapy.      NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is     hoped to increase the effectiveness of radiation therapy.   "
83801|NCT02189096|"     Sepsis claims over 37,000 lives in the United Kingdom each year- more than lung cancer, and     more than breast cancer, bowel cancer and HIV/AIDS combined. Less than two-thirds of patients     who develop sepsis will survive. Sepsis can affect a person of any age, social background,     and can strike irrespective of underlying medical conditions.      An important element in improving the care of patient with sepsis is early identification and     early intervention, both of which have been shown to improve outcomes. Physiological     deterioration often precedes clinical deterioration as patients develop critical illness.     Recognition of this has led to the development of Early Warning Score (EWS) systems which     allow earlier identification of physiological deterioration. By assigning numerical values to     various physiological parameters, a composite score can be assigned to a patient, allowing     early identification of patients who are at risk of critical illness.      EWS were initially developed to assist in the management of patients in the general ward     setting. A recent study has shown that an increased EWS on arrival at the Emergency     Department (ED) is associated with higher odds of adverse outcome amongst patients with     sepsis. Consequently, the use of EWS could facilitate patient pathways to ensure triage to a     high acuity area of the ED and senior clinician involvement at an early stage. The use of a     standard single National EWS (NEWS) across the National Health Service in the United Kingdom     has been recommended to improve patient care.      NEWS also lends itself to extension to pre-hospital care and ambulance services. Most     ambulance services routinely collect the physiological data required to calculate a NEWS     score and indeed some ambulance services have incorporated this into electronic patient     record forms (ePRF). An agreed NEWS score of greater than a specific level could be used as a     trigger for ambulance service pre-alert of a receiving ED.      Point of care measurement of lactate has also been shown to be feasible in the ED. Serum     lactate is recognised as an independent predictor of mortality in sepsis and there may be     potential for combining NEWS systems and point of care to further improve diagnostic accuracy     for patients at risk of adverse outcomes.      In this study, we aim to apply the use of early warning scores and point of care testing to a     cohort of all ambulance patients to assess the feasibility and utility of this approach.   "
83802|NCT02189083|"     On the basis of empirical evidence and clinical practice, the investigators have developed a     formula called Tumor-shrinking Decoction (TSD) used in the treatment of uterine fibroids     (UFs). The investigators preliminary clinical observation has demonstrated the benefits of     TSD in improving UFs.      TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis,     Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina     draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with     vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.      It is hypothesized that TSD can effectively reduce the fibroid size and improve the symptoms     associated with UFs and the greater anti-tumor potency of TSD is associated with higher     therapeutic doses.      To test this hypothesis, one 16-week, double-blind, randomized, two-dose trial will be     conducted in patients with symptomatic UFs to determine whether the high dose (217 g/day) of     TSD could produce significantly greater effects in reducing the fibroid size and improving     its related symptoms and biochemical profiles compared to the lower dose (69 g/day).   "
83804|NCT02189057|"     The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of     depression utilizing platform algorithm products that can allow rapid identification of     pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may     have the potential to optimize treatment selection by improving response, minimizing     unfavorable adverse events / side effects and increasing treatment adherence.   "
83822|NCT02188823|"     The study is a pilot, designed to provide data regarding the feasibility and acceptability of     conducting such a study on a larger scale. The present study is a clinical trial assessing a     programs to help people manage prediabetes and lose weight with a low-carbohydrate diet (LC)     along with information about positive affect, mindful eating strategies, exercise, and sleep.   "
83976|NCT02186925|"     Identifying clinical factors such as medication, background diseases and blood tests that     effect the course of disease in cancer patients can help physicians to better decide on the     patient's treatment plan. The study seeks to identify and analyze relevant clinical factors     that effect the course of the disease and the results of treatment in patients with cancers     of the prostate, bladder and kidney.   "
83805|NCT02189044|"     Introduction: Among the systems of the organism, it is believed that the respiratory system     is the one which gets older faster due to the greater exposure to environmental pollutants     over the years.The Pilates method has emerged as a form of fitness particularly providing     general welfare to the individual. Objective: To evaluate the effects of Pilates' exercises     on respiratory muscle strength in elderly women. Methods: The investigators have studied 07     women aged 60 and over, with preserved autonomy and cognitive skills. The Pulmonary Function     Test (Spirometry) was performed using the Vitalograph® spirometer, model 8600. Respiratory     muscle strength was obtained by technical measurements of maximal inspiratory pressure (MIP)     and maximal expiratory pressure (MEP), through an analog Gerar manometer. The experiment     lasted eleven (11) weeks. For comparative analysis of the data obtained in the evaluations,     the investigators applied the paired t test and a significance level of 5%.   "
83806|NCT02189031|"     Upper limb amputation is a devastating injury that leaves many thousands of typically young     and active individuals in the US to rely on artificial arms and hands to help restore their     lost function. The investigators research is focused on helping these individuals to feel     where their prosthetic limbs are moving without having to look at them by developing devices     and approaches to provide sensory feedback of limb movement through the nerves that once     served the missing limb.   "
83807|NCT02189018|"     Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs     and decreased blood flow to the legs. This may cause difficulty or pain with walking or other     activities that use leg muscles. Exercise may help improve blood flow in the legs and improve     the ability to walk. This research project is being implemented in adults with PAD to examine     the effects of exercise or weight loss programs on lower extremity blood flow, health, and     physical function.   "
83808|NCT02189005|"     The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with     higher than normal blood sugar levels.   "
83809|NCT02188992|"     Between 6 and 16% of patients presenting to hospital emergency departments have infections,     with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue     is that, at time of presentation, it can be difficult to determine who has inflammation as a     result of infection and who does not.      Some of the patients with infections will deteriorate to organ failure ('severe sepsis')     including failure of the heart and blood vessels to maintain normal blood pressure ('septic     shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated with     a significant mortality, which can be reduced by early intervention. However identifying     those patients who are at high risk of deteriorating to septic shock can be difficult on     initial presentation to hospital, and thus these patients risk being 'triaged' to an     inappropriate level of care and/or missing the crucial early interventions which can modify     mortality. Equally failure to identify which patients have underlying infections can lead to     potential inappropriate targeting of antibiotics. Existing clinical and laboratory tests are     often unable to accurately identify those patients with infection, and those who are likely     to deteriorate to severe sepsis and septic shock.      Investigators in this group have recently identified several signatures of immune system     activation which predict those patients who are likely to deteriorate, and which patients     with suspected infection subsequently have this confirmed. Such tests would have major     benefits for the management of patients with early suspected infection and sepsis if they can     be translated into a test usable in everyday clinical practice. This study aims to determine     the prevalence of these markers in a cohort of patients admitted with suspected sepsis, and     their predictive ability for developing established septic shock. From this investigators aim     to derive an optimal test, to be tested in a validation cohort (ExPRES-Sepsis II) which will     be suitable for everyday clinical practice, and thus take the next step towards developing a     market-ready test.      Study hypothesis is:      Measurement of markers of immune activation will allow i) Risk stratification for     deterioration into severe sepsis ii) Risk stratification for death amongst patients     presenting with sepsis iii) Identification of patients with confirmed sepsis   "
83810|NCT02188979|"     BACKGROUND Unpredicted difficult tracheal intubation (DTI) with Macintosh laryngoscopy occurs     frequently in obese patients. We investigated the incidence of DTI using the GlideScope®     videolaryngoscope (GVL) with an algorithm based on a pre-operative assessment with the El     Ganzouri Risk Index (EGRI).      METHODS We prospectively enrolled morbidly obese patients (BMI>40 kg/m2) undergoing abdominal     surgery. Patients were scheduled for flexible fibre optic bronchoscopic intubation (FFBI) or     GVL intubation if the EGRI score was ≥7 or <7, respectively. The primary outcome was the     occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation     Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also     used. Secondary outcomes included intubation success during the first attempt, the time to     Cormack (TTC), the time to intubation (TTI), failure to intubate, oxygen desaturation and     difficult ventilation.   "
83811|NCT02188966|"     In the Emergency Department Regional Hospital Horsens a monitor will display Geographical     Information System data (GIS data) for all ambulances with the hospital as final destination.     The location, estimated time of arrival (ETA) and urgency code for the ambulances will be     showed. Furthermore the patient's name, personal identification number and the primary     message received by the emergency medical dispatch center resulting in ambulance dispatch     will be displayed. This may enable the coordinating nurse to optimize timing of the ad hoc     trauma team and medical emergency team activation. The teams are activated if the patient's     condition is assessed to be of the highest urgency and/or severity - triage 1 or red. The     coordinating nurse makes this assessment on the basis of information from the ambulance     personnel and makes the decision to activate the team and when to do it. In this study the     investigators want to examine if the availability of GIS data in the emergency department     results in reduced waiting time for the members of the trauma team and medical emergency     team. The study will be conducted as a before and after study.   "
83812|NCT02188953|"     The purpose of this study is to pilot test the effectiveness, acceptability, and palatability     of ACCS100 in a high-risk Kenyan population.   "
83813|NCT02188940|"     Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and     a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In     addition, the impact of a weight-loss program on clinical control and psychological outcomes     has been poorly demonstrated and the effect of exercise training remain unknown. The     investigators aim to investigate the effect of exercise training in a weight-loss program on     asthma clinical control (primary outcome), health factors related to quality of life and     psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe     persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be     evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is     more effective to lose weight and improve asthma control, quality of life and psychosocial     symptoms in obese asthmatics.   "
83871|NCT02188186|"     Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option     in the treatment of drug-naïve Korean type 2 diabetic patients.   "
83872|NCT02188173|"     This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema     (DME).   "
83814|NCT02188927|"     Participation in a primary screening colonoscopy programs remains low. Advanced notification     letter has been shown to increase participation in colorectal cancer screening with fecal     occult blood testing and to be cost effective compared to standard invitation. It is unknown     whether advanced notification letter increases participation rate in primary colonoscopy     screening program.      We hypothesize that an Advance Notification Letter will have significant influence on     participation in screening colonoscopy, comparing to standard invitation procedure and will     thus result in higher efficiency of the program.      This randomized controlled study aims to compare the participation rate in screening     colonoscopy in response to advanced notification plus standard invitation letter and standard     invitation letter alone.      Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population     Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy     with advanced notification letter (send two weeks before standard invitation) plus standard     invitation (send six weeks before planned screening colonoscopy) or to standard invitation     only (send six weeks before planned screening colonoscopy). The sample size was calculated to     detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.   "
83815|NCT02188914|"     Inhalants substance misuse is an important public health problem whose prevalence is     approximately 1% in the general population and 7% among high school students in Mexico.     Furthermore Inhalants substance misuse has increased in the recent years (Villatoro et al.,     2011). According to the Diagnostic and Statistical Manual of Mental Disorders fifth edition     (DSM-5) inhalant use disorder is a problematic pattern of use of a hydrocarbon-based inhalant     substance leading to clinically significant impairment or distress. There are studies to     suggest that long-term exposure to inhalants is associated with structural brain     abnormalities, as well as neuropsychological impairments. However many of these studies have     been limited to the gross anatomical report, therefore is necessary the use of complimentary     techniques which provide a better understanding of brain. To the date there is no evidence of     the use of positron emission tomography, and there are few studies have employed other     magnetic resonance imaging methodologies such as diffusion tensor imaging that can be used to     know the metabolic activity and white matter tract integrity respectively in inhalant use     disorder participants. The purpose of this study is evaluates the effects of the inhalant use     disorder in the brain. The investigators will be using positron emission tomography (PET),     Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI). As well as, this study     will examine the impact of inhalants consumption on executive function performance and the     transcriptomic changes associated with inhalants consumption. The investigators hope that the     data gathered from this study will lead to the development of more effective treatments   "
83816|NCT02188901|"     B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma     (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent     for ultrasonography, has reported to have superior sensitivity in detecting focal liver     lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So     our aim is to compare the detection rate of early stage HCC and false referral rate of HCC     between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective     data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%)     than that of B-mode US (3%).   "
83817|NCT02188888|"     Clinical study suggests that beta-blockers by decreasing heart rate together with an increase     in stroke volume do not negatively affect cardiac output allowing an economization of cardiac     work and oxygen consumption in patients with septic shock. Whether this hemodynamic profile     leads to an amelioration of myocardial performance is still unclear. The objective of the     present study is therefore to elucidate whether a reduction in heart rate with esmolol is     associated to an improvement of cardiac efficiency in patients with septic shock who remained     tachycardic after hemodynamic optimization.   "
83818|NCT02188875|"     Previous studies suggest self-regulatory techniques including self-monitoring, and SMS     text-messaging as an intervention modality, can modify health behaviors including physical     activity (PA). The primary purpose of this study was to examine change in objectively     measured PA in a randomized controlled pilot trial that tested a wearable sensor/device     (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in     overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One     and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided     to facilitate self-monitoring with a wearable tracker for instant feedback and website of     daily PA summaries. Outcome measures were number of steps and minutes of PA by     intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week     follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that     text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA     compared to only the Fitbit One at 6-week follow-up.   "
83819|NCT02188862|"     The purpose of this study is to investigate whether there are genetic differences between     patients with rheumatic heart disease and members of the general population.   "
86008|NCT02160236|"     In this study the investigators aimed to compare of postoperative analgesic effects of     intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.   "
83820|NCT02188849|"     To determine, in a double blind trial, the effects of creatine supplementation during 12     weeks on muscle mass and function of community living older women subjected to resistance     training. Material and methods: Fifty healthy older women will be selected for the study. All     participants will be subjected to a progressive resistance training program using elastic     bands and weights, consisting in three sessions per week lasting 1 hour. Participant will be     randomly allocated in a double blind fashion, to receive creatine 5 g per day or an identical     placebo. The training and supplementation period will last 12 weeks. At baseline and at the     end of the study, body composition will be measured by dual energy x-ray absorptiometry,     rectus femoris cross sectional height and surface will be measured by ultrasound, quadriceps     strength will be measured in a quadriceps table and 12 minutes' walk will be assessed. The     main outcome measure will be quadriceps cross sectional height. Expected results: We expect     that creatine supplementation will increase rectus femoris height over and above the effect     of resistance training.   "
83821|NCT02188836|"     This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal     femur fractures using a device developed by the investigators.      The hypothesis is that patients with femoral diaphysis treated with the electromagnetic     stimulation have less non-union after six months than patients treated with a placebo device.   "
83823|NCT02188810|"     This is a phase 1, research study is looking at the safety and acceptability of a new vaccine     adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral)     to test the safety and effectiveness of new vaccines and medications on healthy volunteers.      The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In     the first six months/180 days of the study participants will have visits to the study site     during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3,     participants will be contacted by telephone or email to collect information on any adverse     events.   "
83824|NCT02188797|"     The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered     risk reduction program for homeless young adults. It is hypothesized that youth who     participate in the program will show greater reductions in substance use intentions, behavior     and consequences, as well as sexual activity intentions and risk behavior, over a 3-month     period compared to a usual care control sample of youth who do not participate in the     program.   "
83825|NCT02188784|"     The purpose of this study is to determine if oral iron (Fe) polysaccharide is superior to     oral placebo in improving functional capacity as measured by change in peak VO2 (oxygen     uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with     HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks.      Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral     placebo, therapy with oral Fe polysaccharide will be associated with improvement in     functional capacity at 16 weeks as assessed by CPET.   "
83826|NCT02188771|"     This is a Phase I, prospective, active-controlled, randomized, open-label, clinical trial     designed to assess the safety and tolerability of single intra-articular injection of     RegenoGel-SP for the treatment of OA.      RegenoGel-SP is composed of fibrinogen in plasma linked to a high molecular weight HA. The     viscoelastic properties resulting from the combination of these two natural macromolecules is     further enhanced by joint surface associated factors to generate a viscoelastic gel with     superior stability and mechanical integrity.   "
83827|NCT02188758|"     The goal of this study is to identify chemical compounds in the blood and sputum (i.e.,     biomarkers) that are associated with objective measurements of health status in patients with     cystic fibrosis (CF). This study builds upon observations that blood levels of hepcidin-25, a     protein that regulates how the body uses and stores iron, vary during CF pulmonary     exacerbation (CFPE).   "
83828|NCT02188745|"     Before anti-estrogens such as tamoxifen were developed to treat estrogen receptor     (ER)-positive breast cancer, high-dose estrogen therapies were used. This seems     counterintuitive since anti-estrogens block ER function, while estrogens increase ER     function, but these therapies are effective to similar extents for the treatment of     metastatic ER+ breast cancer. Estrogen therapies are most effective against cancers that     develop resistance to anti-estrogens, likely because such cancers have adapted to grow     without ER function, and restoring ER function (with estrogen) is damaging to the cancer     cells. In some patients with ER+ breast cancer that becomes resistant to anti-estrogens,     treatment with the estrogen 17b-estradiol induces tumor response. Furthermore, when     17b-estradiol-sensitive tumors eventually become resistant to 17b-estradiol, switching back     to anti-estrogen therapy is often effective. These observations suggest that cancers can     alternate between anti-estrogen-sensitive and 17b-estradiol-sensitive states. The     investigators hypothesize that treatment with alternating 17b-estradiol / anti-estrogen     therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth     than continuous treatment with either type of therapy in patients with metastatic     anti-estrogen-resistant ER+ breast cancer.   "
83829|NCT02188732|"     This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and     medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone     (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also     receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3     hypotheses:      Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater     health self-management and greater mental health self-management.      Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater     reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms.      Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute     service use and less acute service use costs.   "
83830|NCT02188719|"     The purpose of this study is look at the safety of:        -  Taking a specific combination of immunosuppressant drugs after liver transplantation        -  Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells          (darTregs) while taking this specific combination of drugs   "
83831|NCT02188706|"     The goal of this clinical research study is to compare the response rates of patients     receiving decitabine alone, decitabine with carboplatin, and decitabine with arsenic trioxide     in patients with AML or MDS.   "
83833|NCT02188680|"     The patients having a syndrome SII would be more intolerant in the fructose than the healthy     subjects and would benefit from a fructose diet but also from the fructans which contain some     fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after     absorption of fructose. However, the eviction of the fructose is sometimes recommended to the     patients without having realized beforehand the test of intolerance.   "
83834|NCT02188667|"     The purpose of this study is to assess the impact of clinician education, electronic health     record integrated patient reported outcomes, and electronic health record integrated decision     support on pain-related care quality, outcomes, and service utilization.   "
83835|NCT02188654|"     Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in     PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic     inflammation and proinflammatory cytokines. Clinical observations and experimental results     argue for an anti-inflammatory and immunosuppressant property of MET.   "
92433|NCT02076217|"     This project will quantify rates of contraceptive failure when unprotected intercourse occurs     5-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's     and Implants).   "
83836|NCT02188641|"     Psoriatic arthritis (PsA) is a particular pattern of inflammatory arthritis often seen in     association with psoriasis. PsA patients have a higher prevalence of comorbidities including     obesity, metabolic syndrome, depression and premature cardiovascular disease. There is     evidence that obesity is associated with PsA. A 12 month study was conducted to determine     whether exercise and dietary weight loss are more efficacious, either separately or in     combination, than standard care alone in improving symptoms and signs in obese adults with     PsA.      Fifty-five obese PsA patients with a body mass index (BMI) ≥30, were recruited. Patients were     randomized into usual lifestyle (controls), diet only, exercise only, and diet plus exercise     groups for 12 months. Disease activity was assessed. Blood samples collected after 12 hours     overnight fasting were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory     cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and interleukin-17     (IL-17). The primary outcome measures included improvement in ACR20. Secondary endpoints     included reduction in PASI score, DAS28-CRP response and physician and patient global     assessment (PGA). Safety and tolerability were also assessed. Data was collected at baseline     and every 6 months.   "
83837|NCT02188628|"     Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore,     and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors     will require specialized rehabilitation. In recent years, robot-aided therapy has been     proposed as a means of complementing traditional therapy to alleviate the burden on     therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots     have been proposed in the literature but only half a dozen have been commercialized and     typically none are seen in local clinics, due to exceedingly high costs. A novel, compact,     inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for     experiments in motor control neuroscience. The H-man can generate computer-controlled force     fields to assist or resist a subject's motion and is potentially an optimal trade-off between     clinical efficacy and robotic complexity. A first prototype of the H-Man is available at     NTU.The primary aim of this proposed project is to assess to what extent the investigators     H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design     involving stroke survivors. The investigators believe that H-Man can be used for     neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and     motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU     engineers, a portable version of the H-Man will be developed which will be tested in a 12     subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT)     study. At the same time, the feasibility of H-Man integration for a pared down home use model     will be assessed in 4 subjects.      The investigators primary hypothesis is that sub-acute/chronic patients will exhibit     clinically significant decreases of impairment when training with the H-Man combined with     standard arm therapy on robot-measured scales and standardized clinical scales, at the level     of elbow/shoulder after 18 sessions of training on the H-Man.   "
83838|NCT02188615|"     The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown     Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in     terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell     esophageal carcinoma.   "
83839|NCT02188602|"     The investigators would like to investigate the effect of chloride dosing on the development     of acute kidney injury in critically ill patients. The investigators hypothesis is that     administering intravenous fluids with higher chloride content are more likely to lead to     acute kidney injury.   "
83840|NCT02188589|"     To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to     severe nasal valve collapse.   "
83841|NCT02188576|"     This research study is being performed to evaluate two different doses of Tranexamic acid     (TXA) in children who have craniosynostosis and have been referred to Boston Children's     Hospital for corrective surgery. This surgery is associated with significant blood loss and     frequently requires the transfusion of blood. TXA is a medication that reduces the amount of     bleeding during surgery by improving clotting of the blood at the surgical site. TXA is an     FDA-approved drug that is routinely used in infants and children undergoing major surgery     including heart surgery, craniofacial surgery and scoliosis surgery. It has been shown to     decrease both the amount of bleeding and the amount of blood transfusion needed. We would     like to compare the different doses of TXA to see if a lower dose has the same effect on     blood loss as a higher dose. We are also interested to learn why TXA seems to work better in     some patients than in others. In order to study the effect of this drug we would like to give     this drug to your child and measure the blood loss and the volume of blood given to your     child during his/her surgery.      The research is being done at two sites; Boston Children's Hospital and Gaslini Children's     Hospital in Genoa, Italy. The main study doctor from Boston Children's Hospital is Dr. Susan     Goobie. The Department of Anesthesiology at Boston Children's Hospital is sponsoring this     study.      We are planning to study a total of 68 infants and children from age 3 months to 6 years old     scheduled for open craniosynostosis surgery at Boston Children's Hospital or Gaslini     Children's Hospital.   "
83842|NCT02188563|"     Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and     neck) and negatively impacts survival and other outcomes, but many patients have difficulty     quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far     have had limited success. This is a pilot randomized controlled trial designed to determine     if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates     for cancer patients who smoke.   "
83843|NCT02188550|"     The purpose of the study is to determine if the combination of Everolimus and Letrozole is     effective in the treatment of women with either recurrent or persistent epithelial ovarian,     fallopian tube, primary peritoneal or endometrial cancer.      Experiments have shown that everolimus (Afinitor®) can prevent cells such as cancer from     growing in number. Therefore, everolimus (Afinitor®) is being tested in specific diseases to     stop cells from growing too fast (as in cancer).      Everolimus (Afinitor®) has been FDA approved for adults with advanced kidney cancer (Renal     Cell Carcinoma). Everolimus (Afinitor®) received approval for patients with subependymal     giant cell astrocytoma (SEGA), a brain tumor seen with genetic conditions called tuberous     sclerosis complex (TSC) who require therapy, but are not candidates for surgery. Everolimus     (Afinitor®) was approved for pancreatic neuroendocrine tumor (PNET) in patients with     unresectable, locally advanced, or metastatic disease. Everolimus (Afinitor®) received     approval for the treatment of postmenopausal women with advanced hormone receptor-positive,     HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure     of treatment with letrozole or anastrozole. Everolimus (Afinitor®) also received approval for     the treatment of patients with TSC who have renal angiomyolipoma not requiring immediate     surgery.      Everolimus (Afinitor®) has been used to treat patients in clinical studies since 2002 and     approximately 25,645 patients (as of 30-Sep-2012) have been treated with everolimus     (Afinitor®).   "
83844|NCT02188537|"     Trial objectives:      To decide whether the addition of nelfinavir to the approved antimyeloma therapy with     bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant     myeloma patients to merit further clinical investigation in a prospective controlled trial.      Additional research questions:      To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the     assessment of the biology of proteasome inhibitor resistance and the identification of     predictive markers for response to nelfinavir-based antimyeloma therapy.   "
83845|NCT02188524|"     For the duration of 10 weeks, participants will be asked to maintain their current levels of     physical activity and to take part in three testing sessions over the course of 10 weeks.     Objective and subjective measurements will be obtained at (week 0), at midpoint (week 5) and     after the intervention terminates (week 10). The objective measurements will be taken by     inserting pressure sensors directly into the shoe and recording the centre of pressure.     Markers will be attached to the surface of the body on the shoulders, feet and belly button     and video recording will be used to assess the movement of the centre of mass. The first task     requires individuals to stand in one spot with their eyes open, and then eyes closed.     Secondly, standing in one place, upon an auditory cue, arms will be lifted to the sky as fast     as possible. Lastly, participants will walk around a set of chairs while music plays and when     the music stops, this is a cue to stop walking. The Timed-Up-and-Go test requires     participants to rise from a seated position, walk 3 meters, turn and return to their original     seated position. The Berg Balance Scale requires the completion of a 14 task sequence which     evaluates balance ability during seated, and various standing positions as well as     transitioning movements. The other measurements taken are collected via a questionnaire about     balance confidence level. Upon arrival, participants are required to report whether they have     experienced a fall since the last class attended and if yes, a follow-up questionnaire is     also required to gain information about the nature of the fall.   "
83846|NCT02188511|"     E-cigarettes are an increasingly popular alternate nicotine delivery system, but nothing is     known about the effects of electronic cigarettes on the lungs. We hypothesize that     e-cigarettes disorder airway epithelial and alveolar macrophages biology. Our goal is not to     carry out a large epidemiologic study of electronic cigarette users to study lung function     and other possible abnormal clinical phenotypes, but rather to focus on whether electronic     cigarette smoke disorders the biology of the lung cells first exposed to the electronic     cigarette smoke, a parameter that is the precursor of abnormalities in lung function and     which is far more sensitive than lung function.   "
83847|NCT02188498|"     The objective of this study is to determine if a non-invasive technique, using an innovative     analysis of electrocardiogram (ECG) data, would allow for detection of respiratory events     during sleep and discrimination between central and obstructive apnea. Obstructive Sleep     Apnea (OSA) is the most common respiratory disturbance seen during sleep, with an estimated     prevalence of 10 % in the population and is strongly associated with the development of     cardiovascular disease. In patients with underlying cardiac disease, particularly in heart     failure (HF), central respiratory events such as Cheyne-Stokes Respiration (CSR) are often     seen during sleep. The presence of CSR is also associated with increased cardiovascular     morbidity and mortality. Currently, the identification and classification of sleep related     respiratory disturbances is performed during over-night sleep studies (polysomnography),     which are labor-intensive, time-consuming, expensive and difficult for patients. Thus, the     development of alternative techniques to assist in the identification of those events in the     outpatient setting is of marked importance for widespread screening of sleep apnea.   "
83848|NCT02188485|"     With the long-term goal of improving interventions for late-life suicide, the purpose of this     study is to examine whether a mechanism by which behavioral interventions reduce risk for     late-life suicide is by increasing social connectedness. The investigators propose to examine     whether a manualized intervention that targets connectedness--ENGAGE--increases connectedness     in older adults who report clinically significant depression and     disconnectedness—operationalized as feeling lonely and/or like a burden on others. The     investigators propose a randomized controlled trial comparing the ENGAGE intervention with     care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social     disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression.     At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social     connectedness, depression, and suicide risk. The investigators hypothesize that those     subjects assigned to ENGAGE will report greater increases in connectedness—measured as     greater belongingness and lower burdensomeness—compared to CAU; that ENGAGE will produce     greater reductions in depression and suicide ideation than CAU; and that changes in     depression will be accounted for changes in social connectedness.   "
84077|NCT02185495|"     Imaging procedures including chest X-ray and low-dose computed tomography may be effective in     lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined     with computer aided detection （CAD) is more effective than LDCT in screening of early lung     cancer.   "
83849|NCT02188472|"     The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and     trimethoprim's possible induction of oxidative stress in human cells. The induction is     examined by comparing changes in oxidative stress in the treatment group with the change in a     placebo group. The study is a randomized-based placebo-controlled study. Each treatment group     consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or     placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and     8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug     treatment with placebo. The results will be published.   "
83850|NCT02188459|"     Smoking during pregnancy adversely affects the health of the mother and her developing baby.     Maternal smoking approximately doubles the risk of miscarriage, placental complications,     preterm delivery, low birth weight and fetal and newborn death. The most common adverse     effect of smoking during pregnancy is low birth weight, which sharply increases the risk of     the newborn becoming ill or dying. In the US, maternal smoking is responsible for 30% of low     birth weight babies, 10% of premature deliveries, and 5% of infant deaths. Fortunately,     smoking cessation by pregnancy week 16, or as late as the third trimester, results in a     near-normal weight infant at birth. Even reductions in smoking increase birth weight.      Despite the known risks, the majority of women who are smoking at the time of their first     prenatal visit continue to smoke. Bupropion is approved by the US Food and Drug     Administration (FDA) for smoking cessation in people who are not pregnant, but there are no     carefully controlled studies on the use of Bupropion to help pregnant women quit smoking.     Bupropion is also FDA approved to treat depression, and some pregnant women have taken it for     that purpose, even though it has not been formally tested. The investigators propose to     conduct a randomized, parallel-group, double-blinded, placebo-controlled, 10 week trial of     Bupropion in 360 pregnant women who smoke daily and wish to quit smoking.      The study has three primary hypotheses. First, the investigators hypothesize that Bupropion     treated subjects will decrease the frequency of smoking more than placebo-treated subjects.     Second the investigators hypothesize that Bupropion treated subjects will have greater     positive pregnancy and child health outcomes than placebo-treated subjects. Third the     investigators hypothesize that Bupropion treated subjects will have decreased frequency of     depressive symptoms and cigarette craving than placebo-treated subjects. These finding will     provide information on the safety and efficacy of bupropion treat for smoking cessation in     pregnant women.   "
83851|NCT02188446|"     Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial     cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol     consumption above two drinks per day is associated with an increased risk of postoperative     morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is     recommended to reduce this risk, but for cancer patients the preoperative period is often     very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of     a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the     Gold Standard Programme (GSP) on the frequency and severity of postoperative complications     after bladder cancer surgery.   "
83852|NCT02188433|"     Although smoking prevalence is decreasing in Hong Kong, there are still 645,000 daily smokers     10.7% ( Thematic Household Survey 2012) and half will be killed by smoking (Lam ,2012) which     accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, & Peto, 2001). Smoking also     accounts for a large amount of medical cost, long-term care and productivity loss of US$688     million (0.6% Hong Kong GDP) (McGhee et al., 2006) (Census & Statistics Department (Hong Kong     Special Administrative Region government), 2001). Smoking is a highly addictive behavior and     it is difficult for smokers with strong nicotine dependence to quit without assistance. On     the other hand, reaching and helping the many smokers who have no intention to quit is a     challenge, because they are unlikely to seek professional help from smoking cessation     services. The Quit and Win programme provides an opportunity to reach and encourage a large     group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits     that smokers participating in the contest will have higher motivation to quit with incentives     and better social support (Cahill & Petera, 2011). Studies have found that such quitting     contests or incentive programs appeared to reach a large number of smokers and demonstrated a     significantly higher quit rate for the quit and win group than for the control group (Cahill     & Rafael, 2008).      The Quit to Win Contest in 2014 and the study's interventions using cut down to quit approach     are theoretically based on the Health Action Process Approach ( HAPA) for the intervention     group (Schwarzer, 2008). The HAPA suggests that one's intention of behavior change can be     fostered by knowing that the new behavior has positive outcomes as opposed to the negative     outcomes that accompany the current behavior; and planning (action planning and coping     planning) which serves as an operative mediator between intentions and behavior. Using     gradual cut down approach on smoking cessation will probably increase smoker's self-efficacy     on smoking cessation as the process could be achieved at the smoker's own perceived pace     without placing too much pressure on themselves but with greater control of self in the     cessation process. This was supported by the evidence that smoking reduction approach led to     a greater self-efficacy to resist smoking and increased subsequent quitting (Broms, Korhonen,     & Kaprio, 2008). Most importantly, reducing cigarette consumption will lower the nicotine     dependence which is associated with later abstinence (Hughes et al., 2004). On the other     hand, quitting immediately will have a less sense of control and may be subjected to relapse     thus lower the self-efficacy on quitting.      Therefore, the present study will examine (1) effectiveness of the cut down to quit (CDTQ)     and quit immediately (QI) approaches; (2) explore the use of Community-Based Participatory     Research (CBPR) model to build capacity and to engage community partners in taking on this     important public health issue for sustainability in the community. In addition, process     evaluation will be conducted to assess the effectiveness of the recruitment activity and how     it is linked with the overall program outcomes.   "
83853|NCT02188420|"     After a stroke, there is an exaggerated inhibitory influence from the non-stroke hemisphere     to the stroke hemisphere. Brain stimulation using repetitive transcranial magnetic     stimulation (rTMS) to the non-stroke hemisphere can decrease this inhibition. Paired     Associative Stimulation (PAS) may be a more effective way to produce this same inhibition, as     shown in healthy subjects. However, it is not known whether this will translate to people     with stroke. PAS consists of a peripheral nerve stimulus paired a short time later with a     cortical stimulus to change the excitability within the brain. Thus the investigators will     apply PAS to people with stroke, but the investigators need to first determine the most     effective interpulse interval (IPI) between the peripheral and cortical stimuli. Our research     question is which of three different IPIs is most effective in changing the excitability of     the brain.      The purpose of this study is to determine the optimal IPI between a peripheral nerve pulse     and a cortical stimulus that will be most effective in changing excitability of the brain in     people with chronic stroke. The investigators hypothesize that the cortical excitability of     the nonstroke hemisphere will be most inhibited with the latency-5ms condition.   "
83854|NCT02188407|"     The aim of the study was to prospectively investigate the influence of one-lung ventilation     (OLV) on the inflammatory response and to identify possible antiinflammatory effects of the     volatile anaesthetic sevoflurane.      Forty patients undergoing thoracic surgery with OLV were enrolled in this prospective,     randomised study. The patients were randomly allocated into two groups to receive either     propofol (Group P) or sevoflurane (Group S) for induction and maintenance of anaesthesia.      Inflammatory mediators (Interleukin 6 (IL6), Interleukin8 (IL8), Interleukin 10 (IL10), (C-     reactive protein)CRP) were measured intra- and postoperatively.      Six hours after surgery oxygenation index (PaO2/FiO2) was calculated and chest X ray was     taken and assessed.      The clinical outcome determinated by postoperative adverse events was assessed as the     secondary endpoint.   "
83855|NCT02188394|"     Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of     headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The     aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic     blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs)     in different areas. We hypothesize that those patients receiving real GON anesthetic blockade     will receive greater improvements in pain nociception. We will conduct a double-blind,     randomized, parallel and placebo-controlled clinical trial where one group will be treated     with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with     placebo.   "
83856|NCT02188381|"     Hypertension is the single most prevalent risk factor for heart diseases, heart failure,     kidney failure and stroke. About 1 in 3 adults in the United States have hypertension.     Approximately 28-30% of hypertensive patients suffer from resistant hypertension (RH).     Inflammation has been implicated in the pathogenesis of the hypertension. Additional data     suggests the involvement of gut microbiota in host normal cardiovascular functions and     pathophysiology. Accumulating evidence demonstrates that antibiotic treatment benefits     patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular     events. Even though these studies did not address effects of antibiotic treatment on the gut     microbiota, it is possible that gut microbiota could affect neurologic inflammation. Finally,     intestinal microbiota has recently been proposed to modulate blood pressure (BP) through     production of short-chain fatty acids. In order to investigate this, the investigators     hypothesize that gut microbiota is involved in the neuroinflammation-mediated initiation and     establishment of RH, and targeting gut microbiota by minocycline would produce beneficial     outcomes in RH.   "
83972|NCT02186977|"     A proof of concept (POC) study will be conducted in 44 volunteers that have been fully     vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and     immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a     newly developed intradermal injection device VAX-ID, compared to intramuscular and     intradermal (Mantoux technique) injection.   "
83857|NCT02188368|"     The purpose of this clinical research study is to evaluate the safety and effectiveness (good     and bad effects) of pomalidomide given as part of a combination therapy that include more     than just steroids to treat subjects with relapsed (subjects whose disease came back) or     refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM).      Pomalidomide (alone or in combination with dexamethasone) has been approved by the United     States Food and Drug Administration (FDA) for the treatment of MM patients who have received     at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated     disease progression on or within 60 days of completion of their last therapy. However, the     use of pomalidomide in combination with other drugs used to treat MM, such as     chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not     approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like     lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere     with the development of small blood vessels that help support tumor growth. Therefore, in     theory, it may reduce or prevent the growth of cancer cells. The testing done with     pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM     both on its own and in combination with dexamethasone. Using another drug class, namely     proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with     another in an established anti-myeloma treatment regimen can frequently overcome resistance     regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the     toxicity profile of the new combinations closely resembled that of the proteasome inhibitor     administered as a single agent. Based on this experience, we hypothesize that the replacement     of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory     MM patient population.   "
83858|NCT02188355|"     The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in     unselected patients representing everyday clinical practice. Also the study will assess the     impact of non-compliance with dual antiplatelet therapy, one month after stent implementation     (frequently observed in every day clinical practice), on stent thrombosis.   "
83859|NCT02188342|"     The primary aim of this study is to determine whether an improvement in aerobic fitness, as     judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group     of older, colorectal cancer patients.   "
83873|NCT02188160|"     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented     clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2     drops instilled in each eye four times daily (QID).   "
83860|NCT02188329|"     The primary purpose of the National Survey of Early Care and Education (NSECE) was to provide     a comprehensive snapshot of both the availability and utilization of early care and education     in the United States. The main objectives of the study included:        -  Providing the first national portrait of the availability of early care and education          for the full spectrum of care providers, including householders and providers from all          50 states and the District of Columbia.        -  Identifying early care and education and school-age care (ECE/SA) needs and preferences          among households in the United States with children under age 13 as they pertain to          supporting both the employment of parents and the development of children.        -  Capturing data on all forms of non-parental care for all children in a household.        -  Providing the perspectives of both families and providers on the services offered in a          system where children are often in multiple arrangements and providers receive funding          from multiple sources.        -  Linking the data set collected with policy-relevant data.        -  Increasing the understanding of the care received by low-income children and how that          varies across communities.      The NSECE is a set of four integrated, nationally representative surveys conducted in 2012.     These were surveys of 1) households with children under 13, 2) home-based providers 3)     center-based providers, and 4) the center-based provider workforce. Together they     characterize the supply of and demand for early care and education in America and permit     better understanding of how well families' needs and preferences coordinate with providers'     offerings and constraints.   "
83861|NCT02188316|"     -  Cold forceps polypectomy and hot biopsy forceps electrocauterization (HBF) are still          widely used methods for endoscopic resection of diminutive colorectal polyps          (DCPs)(polyps smaller than 5 mm). Jumbo forceps may be more effective in the removal of          DCPs because of their larger size.        -  This was a prospective study of consecutive patients undergoing colonoscopy and found to          have at least one diminutive polyp. One experienced endoscopist removed DCPs using          either jumbo or hot biopsy forceps.        -  Aim was to evaluate the histological quality and adequacy of the DCPs resected using          jumbo forceps in comparison with HBF.   "
83862|NCT02188303|"     LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of     the study will assess the safety and tolerability of single doses of LY2944876 in Japanese     participants. Participation is expected to last up to about 7 weeks, not including screening.      Part B of the study will investigate the safety and tolerability of multiple doses of     LY2944876 in non Japanese participants. Participation is expected to last up to about 8     weeks, not including screening.      All doses will be administered as injections into the fatty layer just beneath the skin.      Screening is required within 28 days prior to the start of the study. All participants will     attend a post study safety assessment approximately 6 weeks after their final dose.   "
83863|NCT02188290|"     Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control     data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).   "
83864|NCT02188277|"     1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children          with spastic equine and equinovarus foot deformation in pediatric cerebral palsy        2. To assess the safety of Xeomin® use as compared to Botox® in this patient population   "
83865|NCT02188264|"     This phase I/Ib trial studies the side effects and best dose of selumetinib when given     together with cyclosporine in treating patients with solid tumors or colorectal cancer that     have spread to other places in the body and cannot be cured or controlled with treatment.     Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Biological therapies, such as cyclosporine, use substances made from living     organisms that may stimulate or suppress the immune system in different ways and stop tumor     cells from growing. Giving selumetinib and cyclosporine may be a better treatment for solid     tumors or colorectal cancer.   "
83866|NCT02188251|"     The purpose of this study is to determine the effects of Activamp, a product containing     gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy     overweight adults.   "
92714|NCT02072551|"     The main objective of this study is to evaluate Beta cells in patients with a neonotal     diabetes linked to a genetic abnormality Metabolic caracteristics will described using a     transversal cohort study.   "
83867|NCT02188238|"     The aim of this study is to help us understand how saliva forms a thin film inside the     surfaces of the mouth which is known as the salivary pellicle, and how this film helps to     protect our teeth from decay. We know that the thickness and physical properties (viscosity     and mechanical strength) of the salivary pellicle influences:-        -  How we chew and sense the structure of food in our mouth.        -  How we digest the food and extract nutrients from it.        -  Protection against tooth decay and infection.      However, studies have only recently established the different proteins within the pellicle.     The effects of oral care products (e.g. toothpaste, mouthwash etc.) and ingredients they     contain on pellicle formation and removal remain poorly understood. Therefore we need to     understand how the formation of the salivary pellicle is controlled by ingredients it comes     into contact with such as those from food and oral hygiene products (e.g. toothpaste and     mouthwash).      In this study, we are asking volunteers to provide samples of saliva. We will take the saliva     samples back to our labs and measure how they form films under different conditions and     determine the influence of ingredients from oral hygiene on the film forming properties. We     will also measure the protein content of the saliva sample to see how this affects pellicle     formation. Eventually, this information together with knowledge from other studies, should     lead to the development of more effective oral hygiene products.   "
83868|NCT02188225|"     The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on     improvement quality of life among menopausal women.   "
83869|NCT02188212|"     Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult     patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70     years, provided they fulfill the inclusion criteria and need two single tooth restorations on     contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM     Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium     disilicate on the 1st or 2nd molar randomly allocated to the same tooth position     contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after     receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as     possible adverse events, will be carefully monitored during the entire investigation period.   "
83870|NCT02188199|"     This study will assess the efficacy of products, implants, and procedures for knee and hip     replacement.   "
83875|NCT02188134|"     Per-capita consumption of medication is higher in older adults than any other sector of the     population. In fact, it has been estimated that although older adults comprise 13% of the     population they take 34% of all prescriptions and 30% of the over-the-counter (OTCs) consumed     in the US (National Council on Patient Information and Education, 2010). Given current trends     in aging, the savings, freedom and flexibility that self-medicating provides, as well as the     trends to switch prescription products to an OTC status, it is likely that older adults will     increasingly turn to OTCs as part of their medical regimens for years to come (Hanlon, J et     al, 2001).      In addition to the advantages that self-medicating offers, there are risks. These risks are     more pronounced in older consumers, who are likely experiencing physiological changes (e.g.     pharmacokinetics, pharmacodynamics, perceptual, cognitive and motor); this combines with a     propensity for poly-pharmacy that escalates the likelihood of adverse drug reactions. It has     also been suggested that low health literacy rates in older consumers detrimentally impact     health and health outcomes in this population (Kutner et al., 2005 and Federman et al.,     2009).      Despite the risks associated with improper OTC use, the critical importance of OTC labeling     information (there is no learned intermediary), and the fact that older consumers are     significantly more likely to experience an adverse drug reaction than younger adults,     surprisingly little information exists about the decision making process older adults employ     when selecting and using an OTC product.      We propose to recruit people 65 and older for an eye tracking study of mock OTC brands. The     study has the following objectives:        1. To begin to garner insights regarding the proportion of subjects who closely examine          (e.g. turn to the Drug Facts Label) the labeling of an OTC when deciding whether (or          not) a drug is appropriate for them (based on their health history and current          medications).        2. To quantify and compare the attentive behaviors to specific information (Specifically:          name, active ingredient, symptom relief).        3. To quantify and compare the attentive behaviors to different formats of information          (prominently featured information vs less prominently featured information).        4. To begin to benchmark whether or not older consumers make appropriate choices based on          their current conditions and medication history.   "
83876|NCT02188121|"     Patients with severe mental illness (SMI) die younger than persons in the general population.     Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and     is exacerbated by treatment with second-generation antipsychotics (2GAs). Although the     cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients     receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient     adherence are central problems to reducing cardiovascular risks for patients with SMI. To     address these problems, we propose to conduct a multi-site, open-label, randomized controlled     trial comparing an initial treatment strategy of free, fixed-doses of two generic,     cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental     health clinics versus usual treatment. The study will include adult patients (18+ years old)     with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or     psychosis NOS who have received 2GAs treatment within the past six months from within four     mental health clinics in the Boston area. We have three aims: 1) to compare the proportions     of subjects in each arm who are receiving cardiovascular drug treatment and are adherent to     therapy during 12-months of follow-up; 2) to compare changes in composite (e.g., Framingham     scores) and individual (e.g., lipid levels) cardiovascular risk factor levels using an     intent-to-treat (ITT) approach; and 3) to compare risk factor levels, accounting for     variation in adherence over time, using causal inference techniques to estimate the     per-protocol effect of the intervention. Our three aims examine whether this low cost,     streamlined treatment strategy increases the numbers of subjects receiving cardiovascular     prevention therapy and improves cardiovascular risk levels. We will follow subjects for 12     months, and collect interview and biometric data at baseline and over the following 12     months. Subjects will have the option to continue for another 12 months, during which we will     continue to collect interview and biometric data, but will not prescribe cardiovascular     medications. This population-based initial treatment strategy could be an effective and     efficient approach for overcoming traditional barriers to cardiovascular disease prevention     within the SMI population. Findings from this study will inform efforts to improve care and     outcomes, and to enhance survival for patients with severe mental illness.   "
83877|NCT02188108|"     The overall purpose of this study is to evaluate criterion-related validity of a     newly-developed disease-specific instrument to assess the health-related quality of life     (HRQOL) of patients who have had kidney stones. Specific aims of this study are:        1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin          Stone-QOL by answering the question, Is the Wisconsin Stone-QOL useful for assessing          the HRQOL of patients who form kidney stones from a broad region of North America?        2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients          related to stone interventions and other disease-specific outcomes by answering the          question, Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes          within individuals?   "
83878|NCT02188095|"     Clinical and radiological 3 year results of Excia T® Hip Stem   "
83879|NCT02188082|"     Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of     sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of     IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to     severe chronic systolic heart failure.   "
90568|NCT02100618|"     The purpose of this study is to establish the long-term persistence of the immune response     and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary     study (NCT00541970).   "
83880|NCT02188069|"     SCAD (Spontaneous coronary artery dissection - tear in the arterial wall that is not related     to trauma) is an under-diagnosed and poorly understood condition that mostly affects young     women without common cardiovascular risk factors, and can result in heart attack and death.     This observational study is designed to capture the disease's natural history and     predisposing arteriopathies (medical conditions resulting in changes in the arteries),     treatment strategies, long-term cardiovascular outcomes. It will also improve the diagnosis     of SCAD on coronary angiography by participating clinicians, and provide guidance on     investigating predisposing conditions.   "
83881|NCT02188056|"     Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year     after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated     at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of     these patients, risk factors have been identified (congenital or acquired thrombophilia,     cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the     etiology remains unknown, justifying the need for well-conducted studies to determine other     potential risk factors. In addition, the expansion of treatment options with the arrival on     the market of new direct oral anticoagulants, allows comparative studies on the effectiveness     and frequency of adverse events for each treatment.   "
83882|NCT02188043|"     The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients     at a general hospital to start specialized alcohol treatment in order to assess i) efficacy,     ii) cost-effectiveness and iii) overall societal cost impacts.      The effect of the Relay Model will be investigated in a single-blind pragmatic randomised     controlled trial in which the control group consists of patients referred to treatment by     usual procedures.   "
83883|NCT02188030|"     This study is double-blinded RCT, whose aim is to assess if an individual exercise program is     more effective to reduce complaints in neck, shoulders and arms that an group exercise     program, in industrial workers.      The participants will be randomly allocated to receive 12 treatment sessions of individual     exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes     and will be held twice a week for 12 weeks. Participants will also be encouraged to continue     the use of medicines and other health care.   "
83884|NCT02188017|"     An randomized trial of two maintenance doses of Acthar Gel for patients with chronic     pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.   "
83886|NCT02187991|"     The goal of this clinical research study is to learn if the study drug, alisertib, in     combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with     hormone receptor (HR)-positive, HER2-negative or HR-negative, HER2-negative (triple negative)     locally recurrent or metastatic breast cancer. The safety of alisertib in combination with     paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the     size of the tumor, and laboratory findings obtained while on-study will help the research     team decide if alisertib plus paclitaxel is safe and effective in patients with this type of     breast cancer.      Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the     activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and     survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer,     including breast cancer, and preclinical studies suggest that blocking the activity of this     protein can lead to the death of cancer cells.      Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer,     including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in     cancer therapy, combinations of drugs are often more effective as a treatment than either of     the same drugs used alone.   "
83887|NCT02187978|"     The purpose of this study is to compare the effect of early total oral feeding versus     conventional oral feeding in stable VLBW infants. In current clinical practice, the     introduction of oral feeds for VLBW infants is often preceded by a period of fasting or     minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be     associated with potential disadvantages and increased infectious and metabolic complications     related to prolonged fasting and use of parenteral nutrition. The studies conducted till date     have shown better outcomes and improved postnatal growth with early initiation and fast     advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total oral     feeds on day 1 of life. No such study has been conducted on early total oral feeding but     observational work in our unit has shown it to be safe without any increased incidence of     feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW     infants all over the world, the investigators decided to assess the effect of early total     enteral feeding in stable VLBW infants.   "
83888|NCT02187965|"     Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different     testing days for 2.5 hours each day. On one day the subjects participated in blood pressure     and body weight measurements as well as a muscle biopsy from the thigh. On the second day the     subjects underwent an MRI and MRS scan of the thigh and calf.   "
83889|NCT02187952|"     The primary objective of the proposed study is to determine whether behavioral feeding     intervention impacts mother-child attachment in infants and toddlers with feeding problems.     The investigators propose the following hypotheses:        -  Behavioral feeding intervention will not significantly impact parent-child attachment.        -  Behavioral feeding intervention will not significantly impact parent-child unstructured          play interactions.        -  Severity of feeding problems will decrease after behavioral feeding intervention is          implemented.        -  Behavioral feeding intervention will have either no significant effect or a significant          positive effect on general child behavior.   "
83928|NCT02186405|"     Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and     normal T4 are less known and the indications for treatment of subclinical hypothyroidism are     subject to controversies.      The investigators propose to assess whether the hormone replacement for subclinical     hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and     renal functions and which mechanisms are involved.      Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic     evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried     out before and 6 months after substitution.   "
83929|NCT02186392|"     The purpose of this study is to investigate the impact of exposure to ergonomic circadian     light on physiological and mental parameters in stroke patients admitted for rehabilitation.   "
83890|NCT02187939|"     Get in the GROOVE! will address health disparities impacting underserved youth. Given the     alarming rate of overweight and obesity among high school minority youth, the project will     focus on middle school with the primary aim of reaching middle school girls before unhealthy     habits become firmly ingrained.      The primary aim of the research project is to investigate the impact of two types of summer     science enrichment programs (that focus on health and wellness) on middle school girls'     self-efficacy, health knowledge, health behaviors, and interest in science. One program will     present the curriculum by conventional means (GROOVE condition) while the second program will     include the addition of a closed 3-D virtual world environment to reinforce concepts (GROOVE+     condition).      The following hypotheses will be tested in the randomized controlled trial:        1. Upon completion of the summer program, the enhanced summer program GROOVE+ relative to          the conventional summer program will result in a) increased self-efficacy for adopting          healthy behavior change; b) increased health knowledge; c) enhanced science          self-concept; and e) more positive behavior change (e.g., improved nutrition, increased          physical activity).        2. At follow-up, the enhanced summer program relative to the conventional summer program          will result in further and/or sustained improvements in positive behavior health          behaviors and attitudes.   "
83891|NCT02187926|"     The purpose of this study was to examine the characteristics of patients selected for     treatment with roflumilast and the effectiveness and safety of roflumilast in patients with     severe or very severe COPD treated in Hospital and outpatient specialist ward settings in     Greece.   "
83892|NCT02187913|"     -  About two-thirds of adults in the United States are overweight or obese which can cause          adverse health consequences for those individuals. Post-prandial hyperglycemia is one of          these possible consequences and is associated with a higher risk for Type 2 Diabetes.          Controlling hyperglycemia is important in the prevention of the onset of diabetes and          obesity. Resistant starch is a dietary carbohydrate which is not completely digested in          the gut and produces energy for the body to use. The investigators are interested in          assessing the effects of resistant starch on postprandial blood glucose and insulin          concentrations.        -  Aim: To assess the effects of a resistant starch on post-prandial blood glucose and          insulin concentrations.        -  Hypothesis: A baked snack bar with a resistant starch will blunt and sustain the          post-prandial rise in blood glucose and insulin concentrations compared to a baked snack          bar with maltodextrin (an easily digested carbohydrate).   "
83893|NCT02187900|"     The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii     HOOK. f. is effective and safe in the treatment of IgA nephropathy.   "
83905|NCT02187744|"     The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014     (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus     Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin     (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant     setting. The hypothesis to be tested in this study is the percentage of patients with steady     state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to     EU-approved trastuzumab, using a margin of -12.5%.   "
83894|NCT02187887|"     The primary objective of the research study is to test the feasibility of a brief     Internet-based intervention to reduce heavy alcohol use among young adult veterans of wars in     Iraq and Afghanistan. Veterans are recruited through the social media website Facebook in two     phases. In the first phase, investigators collect data from 800 veteran participants to     document and analyze drinking norms in this population. In the second phase, investigators     use the norms collected in Phase 1 and information from the analyses to develop and pilot     test an online intervention with young adult veteran participants. Six hundred participants     are recruited through Facebook and randomly assigned to intervention (N = 300) or control (N     = 300) conditions. It is hypothesized that those in the intervention condition will drink     less at a one-month follow-up period than those in the control condition. Investigators also     collect feedback from participants on the usability of the online intervention.   "
83895|NCT02187874|"     Early cord clamping after delivery has been common practice for many decades as part of the     active management of the third stage of labour. However in recent years, several studies have     shown that delayed cord clamping may offer important benefits to the newborn. The data     gathered indicate that delayed cord clamping may be particularly useful in premature babies,     between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the     incidence of intraventricular haemorrhage.      However it is argued that the described potential benefits of delayed cord clamping could be     negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by     potential interference with the postpartum haemorrhage management, initial care and     reanimation of the premature newborn, and the possibility of cord blood donation. These     factors, together with as the lack of homogeneity among existing studies regarding the     delayed cord clamping technique create the need, in our opinion, for further research, to     establish the proper place of this measure.      Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces     the need for blood transfusions and intraventricular haemorrhage, compared with usual early     cord clamping.      Secondary outcomes:        -  To define the impact of delayed cord clamping on neonatal assessment parameters after          delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.        -  Neonatal mortality and morbidity        -  Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage        -  To study the correlation between Iron metabolism and reticulocitary haemoglobin levels          in cord and infant blood.   "
83930|NCT02186379|"     The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace)     to help children at risk for obesity (children who eat rapidly and have an overweight     parent/legal guardian) develop a more normal eating rate.   "
84001|NCT02186600|"     The purpose of this study is to identify the best way to prevent bone loss in the first years     after menopause. The HOPE study will compare bone loss at 12 months in women: 1) who take     calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication     risedronate; or 3) who take calcium and vitamin D plus participate in bone-loading     exercises. Our central hypothesis is that improvements in bone health will be greater in     women randomized to bone-loading exercises with calcium and vitamin D compared to women who     take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.   "
83896|NCT02187861|"     This open-label, international, multicenter study will investigate the safety and efficacy of     GDC-0199 in combination with bendamustine plus rituximab (GDC-0199 + BR) compared with BR     alone in participants with relapsed and refractory fNHL, comparing two     chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an     exploratory analysis of the safety and efficacy of GDC-0199 in combination with rituximab     (GDC-0199 + Rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free     Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be     decided at the discretion of the investigator, unless one of the cohorts is not open to     enrollment; in which case, participants may be enrolled only to the open cohort. The first 6     participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will     comprise the Safety Run-In group for Treatment Arm B, dosing GDC-0199 at 600 milligrams (mg)     in combination with BR. Once a dose has been chosen from the Safety Run-In Period,     randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C)     will begin. The anticipated time on study treatment is approximately 24-52 weeks, depending     on treatment arm.   "
83897|NCT02187848|"     Primary Objectives:      To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once     every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid     tumors (Escalation Phase).      To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)     (Expansion Phase) of SAR408701 administered once every 2 weeks without a loading dose at     Cycle 1.      Secondary Objectives:      To characterize the overall safety profile of SAR408701. To characterize the pharmacokinetic     (PK) profile of SAR408701 and of its potential circulating derivatives.      To identify the recommended phase 2 dose (RP2D) of SAR408701. To assess the potential     immunogenicity of SAR408701.   "
83898|NCT02187835|"     Aim was to detect EEG complexity in a specific group of patients to contribute to the     discussion whether schizophrenia is associated with increased or decreased complexity. We     included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized     that chronic residual schizophrenia is characterized by decreased complexity in EEG.   "
83899|NCT02187822|"     The main purpose of this study is to see whether addition of TPI 287 to FSRT is safe and     tolerable. Researchers also want to find out if adding TPI 287 to FSRT can help with better     controlling the growth of brain lesions in people with brain metastases from their cancer.   "
83900|NCT02187809|"     To investigate the long-term safety and tolerability of clobazam when administered for 1 year     as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.   "
83901|NCT02187796|"     1. To determine, in the Quillen College of Medicine HIV+ outpatient clinic, the prevalence          of             -  NC (normal cognition )             -  ANI (asymptomatic neurocognitive impairment )             -  MCD (mild cognitive disorder )             -  HAD (HIV-associated dementia )        2. To determine whether the following variables affect the three categories of HAND             -  Time since first diagnosis of HIV infection             -  Anti-viral medications used             -  Age             -  Gender   "
83902|NCT02187783|"     The purpose of this signal seeking study is to determine whether treatment with LEE011     demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic     malignancies to warrant further study.   "
83903|NCT02187770|"     The purpose of this study is to determine if IMED-4 recordings have sufficient precision to     detect a clinically significant change in lung fluid status in acute heart failure syndrome     with pulmonary congestion.   "
83904|NCT02187757|"     Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood     lipid levels   "
83977|NCT02186912|"     Indication : edentulous patients To evaluate and compare the marginal bone level change     around tilted and straight NobelActive implants placed in healed sites with     All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge     (fixed) in the mandible and maxilla.   "
83906|NCT02187731|"     The FULIMA study is a two-center study at Odense University Hospital and Vejle Hospital,     Denmark. The primary objective is to identify the optimal imaging technique for studies in     multiple myeloma with focus on PET/CT and MRI.      By combining early (1 hour) and late (3 hours) 18F-2-fluoro-2-deoxy-D-     fluorodeoxyglucose(18F-FDG)-PET/CT scans the investigators expect to see increased uptake of     radioactive tracer and thus an improved ability to identify malignant tissue. A second tracer     18F-natrium-fluoride is used to explore early signs of bone remodeling. By using new software     (ROVER) for interpreting PET data the investigators expect to obtain a quantitative     measurement of total disease burden with less risk of misinterpretation of data.      Diffusion weighted MRI (DWI) is a new MRI technique which, like PET/CT, makes it possible     quantitatively to calculate the overall disease activity and to give an early evaluation of     response to chemotherapy. The study examines DWI for development and standardization.      To validate imaging findings and to explore the pathogenetic heterogeneity of multiple     myeloma, the investigators perform CT guided biopsies from PET/ DWI positive sites.     Pathoanatomical and immunohistochemical findings and gene expression data from positive sites     are compared to random bone marrow. The question is whether disease heterogeneity may explain     the lack of FDG uptake in bone marrow in some patients? To the extent that the FULIMA study     produces useful data, the defined and standardized imaging techniques will form the basis of     a larger prospective study at national level in Denmark.   "
83907|NCT02187718|"     Rationale: In breast cancer (BC) patients, lymph node status is a key prognostic indicator.     At present, axillary ultrasound (US) with subsequent fine needle aspiration cytology (FNAC)     of suspicious lymph nodes (US+FNAC) is widely used as a pre-operative staging method. When     US+FNAC is negative, a sentinel node procedure (SNP) is performed during breast surgery.     Nowadays, an axillary lymph node dissection (ALND) is generally performed if one of the     abovementioned diagnostic entities reveals lymph node metastases. However, the extensive role     of ALND in BC patients with lymph node metastases may change or diminish in upcoming years     due to emerging evidence that completion ALND (cALND) does not affect disease-free survival     and overall survival in early BC patients with (sentinel) node-positive disease. Whether ALND     is needed in these patients, should be based on (axillary) tumour load. Because of the fact     that tumour load can only be reliably evaluated by SNP and not by US+FNAC, the role of SNP     might become even more important in upcoming years.      Ideally, the status of this sentinel lymph node is known prior to breast surgery, so a     patient tailored treatment plan can be made and discussed with the patient before breast     surgery. In this context, it would be very logical to perform a SNP under local anaesthesia     (LA), prior to breast surgery. This might not only lead to significantly less two-step     surgical procedures under general anaesthesia (GA), but might also lead to a reduction of     depressive symptoms and anxiety and improved quality of life (QoL) of BC patients, because BC     patients are in particular risk for psychological distress in the first three months after     diagnosis of BC. Knowing lymph node status and the complete treatment plan as soon as     possible (by performing a SNP under LA), might reduce this psychological distress. To     investigate which BC patients would benefit most from SNP under LA, the investigators     recently analysed 1132 BC patients retrospectively. Both prevalence of axillary lymph node     metastases and prevalence of false negative results of US+FNAC were directly associated with     age <60 years and with primary breast tumour size >20 mm. Hence, these BC patients might     benefit most from SNP under LA. In the present study, the value of SNP under LA in these BC     patients (i.e. <60 years with a breast carcinoma >20 mm) will be analysed.      Objectives: Reduction of the mean number of operations under general anaesthesia per patient.     Improvement of QoL. Reduction of depressive symptoms and experienced anxiety.      Study design: Prospective single centre randomised controlled clinical trial. Study     population: Women aged 18 to 60 years who are diagnosed with BC AND with a tumour size of >20     mm ultrasonographically AND with a negative or inconclusive pre-operative US+FNAC.      Intervention: Sentinel Node Procedure under Local Anaesthesia (SNP under LA) Control:     Traditional Sentinel Node Procedure under General Anaesthesia (SNP under GA) Main study     parameters: Primary outcome parameters are the number of operations under GA per patient and     the number of operations under LA per patient. Secondary outcome parameters are QoL,     experienced depressive symptoms and anxiety.      Timeline and statistics: The inclusion period will be conducted from the 1st of July 2014 to     the 1st of August 2015, and 80 patients will be enrolled in this study (alpha 0.05; power     0.8). Inclusion of 80 patients will be sufficient to reduce the number of two-stage surgical     procedures under general anaesthesia with 30%. Data will be analysed using descriptive     statistics, Chi-squared test, Fisher's exact test, Mann-Whitney U test, Kruskall-Wallis test,     students t-test, ANOVA, paired t-test, Wilcoxon signed-rank test, Friedman test, Pearson's     and Spearman's rank correlation coefficients and finally logistic and linear regression     analysis.   "
83908|NCT02187705|"     The aim of this observational study was to supplement the data on efficacy, safety, and     tolerability of telmisartan under daily conditions in hospitals   "
83909|NCT02187692|"     The aim of the study is to compare the effectiveness of the meta-cognitive training (MCT) for     schizophrenia against treatment as usual (TAU) among patients who attends community support     groups. 4 weeks of MCT will be administered for patients two times per week. MCT consists of     well structured cognitive behavioral therapy interventions. MCT will be administered     according authors recommendations. All participants will be assessed at baseline (T0) and up     to one week after the MCT intervention (T1, 4-5 week of the study).   "
83971|NCT02186990|"     The purpose of this study is to evaluate the effect of propofol, etomidate and     propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal     intubation and assess the adverse effect related to this drugs.   "
83910|NCT02187679|"     Our intervention will be the injection of Abobotulinum toxin A into the affected site/vocal     cords for patients with the diagnosis of Primary Tourette's syndrome. This is an efficacy     trial to understand the right dosage of Abobotulinum toxin A which can be affective. The     study will involve an injection of 2.5 units of Dysport on each side of the affected vocal     cords for patients with a diagnosis of Primary Tourette's syndrome. The patients will also     complete a self assessment survey on how vocal tics affect their daily lives. Afterward, a     further evaluation of the tics will be conducted by the investigator using the Yale Global     Tic Severity Scale. (YGTSS) evaluation. How this will be done is by a licensed ENT (Ear, Nose     and Throat) physician. The windpipe will be number by a 2% lidocaine followed by a provoked     cough by the patient. This will allow the lidocaine to be sprayed throughout the airway     preventing coughing and swallowing during the procedure. An Electromyography (EMG) guidance a     needle containing Dysport will be injected into the thyroarytenoid muscles will potentially     reduce the vocal dyskinetic features in patients with TS. This needle will be connected to a     syringe and once determined active, it will be placed appropriately when the EMG emits a     characteristic sound. If this does not occur with the patient then the injection will be     administered under direct vision via direct laryngoscopy using an orotracheal injector     system.      This procedure is conducted in an outpatient clinic because no hospitalization is required.     The patient is not allowed to consume food or drink for about 45-60 minutes after the     injection. The throat will be numb and may cause coughing and some blood tinged sputum: The     expectancy of this outcome is reason to not consider is a serious event. Asprin and ibuprofen     is not allowed a week prior to and until the injection at least 3-4 days after to prevent     excessive bleeding. The patient is also instructed to ensure that they chew their food     thoroughly and drink sufficient water for the initial days after the study intervention. Mild     dysphasia may be noted initially which should resolve within a few hours. On Visit 1, the     patient will complete all required study documents and forms. Then the ENT physician will     proceed with the injection Dysport on the same day. If unforeseen circumstances render the     subject unable to be injected on the same day, the intervention must take place within three     days and this will be considered V1, follow up events should be scheduled accordingly.   "
83911|NCT02187666|"     The primary objective of the Spine Registry is to enhance the understanding of spinal disease     and treatment of spinal disease with the goal of guiding treatment options.   "
83912|NCT02187653|"     The primary objective of this study is to evaluate the rate of new or worsening neurologic     deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using     neurological testing (motor and sensory) in the optimal management of the surgical patient.   "
83913|NCT02187640|"     This study is to evaluate the effects of self-administered acupressure therapy for     psychiatric in-patients with constipation      Two main research questions include:        1. What are the effects of the standardized self-administered acupressure program on          reducing those adult psychiatric patients' symptoms of constipation?        2. What are the psychiatric patients' (participants') perceived benefits and limitations of          self-administered acupressure on management of their constipation?      In this study, the participants who met the study criteria and completed the baseline     measurement would be randomly assigned into either the self-administered acupressure program,     or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of     this study are:        1. There is no significant difference between the acupressure and sham group immediately          and/or two weeks after the completion of intervention on patients' symptom severity of          constipation; and        2. There is no significant difference between the acupressure and sham group on patients'          perceived quality of life at immediately and two weeks after treatment completion.   "
83914|NCT02187627|"     This study is designed to obtain basic information on three PET imaging tracers developed to     detect tau pathology in the brain. In this study, healthy control participants and     participants with AD will be studied. Information collected will include brain and plasma     kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest     variability of the signal in the brain. The study will consist of Part 1, Part 2A, and Part     2B. During Part 1, imaging data will be assessed on an ongoing basis and based on data, one     tracer will be prioritized over the other two tracers. The tracer selected will be further     investigated in Part 2A and Part 2B.   "
83951|NCT02187250|"     The purpose of this study was to determine whether monotherapy treatment with     phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with     glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the     treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who     have not been treated before. The investigators anticipated greater changes in body weight in     patients on roflumilast treatment than in liraglutide or metformin.   "
83952|NCT02187237|"     The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area     that emit laser light to reduce the circumference waistline.   "
83915|NCT02187614|"     Abdominal pain is one of the most common presentations to an emergency department (ED). Among     patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic     (urolithiasis or Kidney stones). As the patients with renal colic writhe around in agonizing     pain, the first priority in an ED from a patient's perspective is fast and safe analgesia and     to be pain free as early as possible. There are variations in physician preference to choose     initial analgesic drug for managing such pain. Commonly used drugs are:        -  Opioids such as Morphine or Fentanyl        -  Non steroidal drugs such as Diclofenac, Ketorolac or Brufen        -  and Paracetamol intravenous injection.      A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking.     This study is design to obtain data on efficacy of these three drugs within 30 minutes in a     non inferiority trail.   "
83916|NCT02187601|"     The aim of the study is to confirm that the new generation state of the art breath analyzer     gives equivalent results to the previous model of the Exalenz breath analyzer.   "
83917|NCT02187588|"     Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia     Californica per os and placebo in patients undergoing dental surgery over an observation     period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between     Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg   "
83918|NCT02187575|"     Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules     (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.   "
83919|NCT02187562|"     The objective of this study was to investigate the influence of meloxicam on low dose aspirin     induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before     aspirin.   "
83920|NCT02187549|"     The purpose of this study is to determine whether intra-articular hyaluronic acid provides     symptomatic relief of osteoarthritis of the knee.   "
83921|NCT02187536|"     To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant     administration of telmisartan   "
83922|NCT02187523|"     A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose     combination in comparison to the single unit formulations   "
83931|NCT02186366|"     Generalized Anxiety Disorder (GAD) is characterized by the presence of persistent worry or     fear of no explicit object and fixed content, or things that might occur in real life，which     not corresponds with the realities. Patients with GAD may occur a series of somatic symptoms     including muscle tension, backaches, headaches, fatigue, insomnia, restlessness, as well as     psychological feelings of anxiety, worry and feeling overwhelmed. And it always brings some     type of functional disability or decrease in quality of life. GAD is treated by Selective     Serotonin Reuptake Inhibitors (SSRIs) or Serotonin, Norepinephrine Reuptake Inhibitors(SNRI)     and 5-ht1a receptor agonists as regular medication which have the definite effects. But, some     adverse reaction of SSRIs or SNRI leads to the compliance of taking medicine of patients with     GAD. There is an impressive data suggesting that Abdominal Massage Therapy is effective in     decreasing some symptoms of somatic symptoms and psychological feelings.      This study is designed as a parallel group, positive control, non-inferiority study. It will     recruit 140 cases of generalized anxiety disorder of deficiency of both heart and spleen     type. Both the treatment group and the control group will be randomly assigned 70 cases.     Patients in the treatment group will be treated by Abdominal Massage for 6 weeks，and the     control group by buspirone . The total study includes 4 views that are respectively before     the treatment，after 3 weeks treatment, after the whole treatment , and 3 months after the     whole treatment. At all of the 4 views, all participants will be estimated the scores of     Hamilton Depression Scale(HAMD) ,self-rating anxiety scale(SAS), and Quality of life     assessment scale. At the second, third and the forth views, all participants will be     estimated Clinical Global Impression ( CGI). At the first and the third views, all     participants will be collected the data of content of hydroxytryptamine（5-HT）, Norepinephrine     and total cortisol in blood plasma, and of blood stream speed, vascular resistance index and     pulsatility index of middle cerebral artery （MCA）, anterior cerebral artery（ACA）, posterior     cerebral artery （PCA） and basilar artery（BA）. This study aims to investigate the efficacy of     Abdominal Massage Therapy vs. buspirone, and discover the correlation between these scales     and these objective indicators.   "
83932|NCT02186353|"     The primary objective of this pilot study will be to examine the effects of consuming whole     grains, differing in the degree of processing, on insulin sensitivity and other     cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets     and to generate preliminary data.   "
83933|NCT02186340|"     The improvement in inspiratory muscle function might result in beneficial changes in     breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory     muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing     pattern during an incremental cycle exercise.   "
83934|NCT02186327|"     This study examines a pilot project to introduce integrative health coaching to two community     clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke     Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site     (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a 3-month     period at no cost by coaching trainees completing their certification hours. Pre and post     measurements of BMI, patient activation, and perceived interpersonal support will be     collected and analyzed for interaction effects. Qualitative process evaluation will be     conducted as a thematic analysis via guided interviews with stakeholders and participants,     using the RE-AIM framework. Feasibility measures will include recruitment of both coaches     and clients, subject/client retention, and number and duration of coaching sessions     completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a     post-intervention focus group that addresses the impact of coaching on perception of     health-related resources and needs in the community.      Primary Hypotheses:      Integrative health coaching will be a feasible intervention in both community and clinical     settings, in terms of required resources, patient or client adherence, and satisfaction by     community stakeholders, including providers and participants.      Additional hypotheses:      Individuals who receive integrative health coaching sessions as an adjunct to their standard     medical care will see improvements in patient activation and perception of interpersonal     supports, when compared to controls.      Individuals who receive integrative health coaching (or in the case of the pediatric cohort,     children of individuals who receive coaching) will see minor improvements in BMI over the     study period when compared to controls.   "
83935|NCT02186314|"     In this study we will select twenty patients with chronic atrial fibrillation and ventricular     dysfunction with permanent cardiac pacemaker indication. We will dosage serum level     natriuretic peptides for comparison between conventional and bifocal cardiac pacing.   "
83936|NCT02187445|"     Acute and chronic pulmonary complications with concomitant inflammatory response are a     leading cause of morbidity and mortality in children with sickle cell disease (SCD). Acute     chest syndrome (ACS), defined broadly as an increase in respiratory effort, fever and new     radiodensity on chest x-ray, is a major cause of death in children and adults with SCD. There     is a high rate of ACS in children between 1 and 4 years of age that is associated with an     asthma diagnosis, and children with ACS events before 4 years of age have a 50% rate of being     hospitalized for either ACS or pain within 1 year of admission. For children with SCD that     develop ACS, the investigators propose that the use of budesonide inhalation suspension (BIS)     will attenuate pulmonary inflammation after an ACS episode and will decrease future     vaso-occlusive pain and ACS episodes. Through a single-arm prospective feasibility trial and     in preparation for a limited-institution randomized trial, the investigators plan to test the     following primary hypothesis for a phase III definitive trial: In children with SCD admitted     to the hospital for an ACS episode between 1 and 4 years of age, low dose BIS for 6 months     will result in a 50% reduction in the recurrent incidence rate of ACS or pain requiring     hospitalization. Through this trial, the investigators will determine the acceptability of     and adherence to BIS in the study population. The investigators will track respiratory     symptoms in cases versus controls over 6 months. Finally, the investigators will explore the     impact of BIS on biological correlates (sVCAM-1).   "
83937|NCT02187432|"     EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant     polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational     cohort study has the potential to identify progression factors and biomarkers, and to assess     disease stage specific mortality, morbidity and health care costs.   "
83938|NCT02187419|"     The purpose of this study is to determine feasibility and adherence to a hypnosis program to     improve sleep. It is theorized (based on prior experience and pilot data) that one or more     hypnosis program(s) will be feasible and will exhibit acceptable adherence. The programs will     assess to determine optimal dose (3 vs 5 sessions) and method (audio-recorded vs therapist     delivered).   "
83939|NCT02187406|"     Identify, quantify and compare the fatigue caused in two ankle athletic tapes after the     completion of a tennis warm-up.   "
83940|NCT02187393|"     The investigators are trying to understand the role of specific genes in the function of     airway surface cells. The investigators know that there are some common genetic markers that     are associated with various lung diseases. However, most people with these genetic markers     never develop any evidence of lung disease, so it is not understand how or if these markers     play a role in disease. Investigators are asking healthy people to provide three (3) tubes of     blood as well as a sample of cells from their nose. Investigators will use the blood sample     to provide genetic information (specifically, presence or absence of alleles known to be     associated with pulmonary fibrosis). Nose cells from individuals with the genetic markers     that investigators are studying will be grown in the the lab to allow investigators to learn     more about how the cells respond to various forms of environmental stress, such as exposure     to cigarette smoke. The goal of this study is to understand how specific genes affect airway     cell function.   "
83941|NCT02187380|"     The objective of the SIMCA study was to analyse the impact of structured medication     counselling by community pharmacists on medication adherence, economic, clinical and     humanistic outcomes of depressed primary care patients who started a new treatment with     antidepressants.      A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At     the time of the start of the study, the Surplus Network included 97 pharmacies, in all five     Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were     informed about the SIMCA-study and instructed how to approach eligible patients.      Randomisation was obtained at the pharmacy level by a computerized random-number generator,     following a permuted block design (1:1). The Surplus Network contains a number of local     pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy     chains.      Pharmacists in the intervention group were trained in communication skills related to     depression treatment counselling in groups of no more than 10 participants over a single day.     In total, 10 training days were scheduled between November and December, 2010.      Patients were eligible for inclusion in the study if they started using at least one     antidepressant drug, if they were at least 18 years old, if they were able to understand and     complete Dutch questionnaires and if they could be reached by telephone for follow-up.     Starting was defined as not having been prescribed antidepressants over the last six     months, which was checked in the pharmacy records. If the patient gave verbal consent to the     pharmacist, to be contacted by the research team, the patient was provided with written and     oral information about the SIMCA project and a consent form. At the same time an automatic     e-mail was generated from the pharmacy software to inform the research team about the     patient's willingness to be contacted about the study. The patient was contacted by the     research team, as soon as possible to give more information about the study, to ask for     informed consent and to schedule a first telephone survey interview. If the patient wished to     participate, he/she completed the consent form, and sent it back with the included     postage-paid envelope addressed to the research team. Upon receipt of the consent form, the     recruited patient's prescribing doctor was contacted and asked to complete and return a brief     questionnaire to provide the diagnosis and its severity related to prescribing     antidepressants.      Telephone survey interviews based on validated scales were used to collect data at the start     of treatment (as close as possible to the time of recruitment), after one month, three months     and six months of treatment.   "
83978|NCT02186899|"     Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few     years peripheral nerve blocks have increased their popularity for this kind of operation. The     investigators want to see how the type of anesthesia and postoperative analgesia effects the     time required for patient mobilisation.   "
83979|NCT02186886|"     Aim of this study is to determine wether the macromolecular spectral characteristic of     ulcerative colitis patients - measured by Physiological Intermolecular Modification     Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment   "
83942|NCT02187367|"     The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an     adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to     removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is     prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation     of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result     from previous studies demonstrated positive correlation between extended survival and immune     response against the vaccination in the late-stage NSCLC patients' age below 60 with improved     quality of life. The purpose of this international Phase 3 trial is to determine whether the     recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of     stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type     EGF-Receptor compared to standard treatment and supportive care.   "
83943|NCT02187354|"     Primary Objective:      To estimate the incidence of treatment-emergent and treatment-related adverse events during     treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in     second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to     other treatments      Secondary Objective(s):      To describe key efficacy outcomes, including incidence of complete response (CR) within 2     cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of     blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and     100-day mortality after alloHSCT.      Hypotheses:      A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and     treatment-related adverse events will be estimated.      Study Endpoints:        -  Incidence of treatment-emergent and treatment-related adverse events        -  Incidence of CR within 2 cycles of blinatumomab        -  MRD remission within 2 cycles of blinatumomab        -  RFS        -  OS        -  Incidence of alloHSCT        -  100-day mortality after alloHSCT      Study Design:      Multi-center, open-label, single-arm expanded access protocol   "
83944|NCT02187341|"     It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it     has been shown that intense exercise stimulates an increase in plasma and salivary cortisol     levels. The purpose of this study is to examine the combined effects of 5-HTP + intense     exercise on plasma and salivary cortisol levels.   "
83945|NCT02187328|"     The purpose of this study is to determine whether grapefruit juice alters the metabolism of     cortisol following intense exercise.   "
83946|NCT02187315|"     Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent     combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with     induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with     intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of     locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two     groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative     effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.   "
83947|NCT02187302|"     This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which     has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101     in combination with bevacizumab compared to treatment with a standard of care therapy. The     study will compare which treatment resulted in longer time before progression of the RCC.     Patients will be treated and followed for progression of their disease on average for up to 6     months.   "
83948|NCT02187289|"     Lymphedema (significant arm swelling on the surgical side) is one of the most common     complications following treatment for breast cancer. The impact of lymphedema is profound,     resulting in negative self image, increased anxiety and poorer quality of life. In time,     lymphedema can result in recurrent infections in the arm, functional impairment and pain.     Approximately 21% of women who undergo breast cancer treatment develop lymphedema.     Unfortunately this is a life-time condition which tends to worsen over time. Currently,     treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the     wearing of compression sleeves during the day for maintenance. This study hopes to show that     the addition of night-time compression creates a measurable reduction in arm volume and that     adding night-time compression to the standard care (daytime compression only) will produce     improvements in quality of life for breast cancer survivors.   "
83949|NCT02187276|"     Background and objectives: The aims of this naturalistic study were: to analyze factors which     could be predictive of good response to cholinesterase inhibitors (ChEI), such as: age, sex,     schooling, mild (CDR 1) or moderate Alzheimer's disease (AD),(CDR 2), Apoliprotein epsilon 4     (APOE Ɛ4), among others, in their cognitive and clinical response. We also classified     patients according to their response to Mini mental State of Examination (MMSE). Finally we     saw the polymorphisms of APO E and cytochrome P450 2D6 (CYP2D6) and tried to correlate the     response with different allelic forms of Apo E and among others with wild type homozygotes     (wt/wt) and their polymorphisms (CYP2D6*3,*4, *5, *6 and 10) of CYP 2D6.      Patients and Methods: 129 patients were diagnosed as AD or AD+cerebrovascular disease (CVD)     mild or moderate. After 12 month-treatment, 97 patients completed the study. They were     assessed (four) times. In the first visit, without taking ChEI, after 3, 6 and 12     month-treatment, they were taking donepezil or rivastigmine or galantamine. We also extracted     5 mL of blood sample to genotype the DNA. In each visit, we applied cognitive, functional,     mood and behavior scales. Good responders were defined as those who scored > 2 in MMSE.      Results and Conclusion: In longitudinal analysis, patients with mild AD and good responders     at 3 months were considered good responders at 12 months. We obtained a higher rate of good     responders comparing with other researches (27.8%). There was no correlation between dose,     APOE and CYP 2D6 polymorphisms, although we already obtained clinical results with the dose     dosage of 5mg.   "
83950|NCT02187263|"     This is a joint project by Heidelberg University and Greifswald University.      Our objective is to establish an unique national multi-center registry and biobank of well     phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical,     molecular and omics-based phenotyping to serve as:        1. central hub for clinical outcome studies.        2. joint resource for diagnostic and therapeutic trials.        3. common biomaterial bank.        4. resource for detailed molecular analyses on patients' biomaterials and patient specific          model systems.   "
83953|NCT02187224|"     This is a randomized control trial with 36 participants diagnosed with post-traumatic stress     disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive     either progesterone (200 mg. bid) or placebo in identical looking capsules for three days.      One goal of this research study is to test if progesterone is more effective than placebo in     reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm     among men and women with AD and PTSD. We hypothesize that progesterone in comparison to     placebo will significantly reduce craving for alcohol in response to trauma cues alone and in     combination with alcohol cues in individuals with AD and PTSD.      A second goal is to examine if there are gender differences in progesterone effects on stress     and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress     and craving will be stronger in women than in men. Participants will be recruited primarily     through advertisement, but also through the clinical facilities at the VA and from other     collaborators.   "
83954|NCT02187211|"     This is a double-blind, placebo-controlled, outpatient study with a between-groups design.     Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or     400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3     outpatient visits for medication administration, dispensing of take-home doses and monitoring     of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will     have 2 laboratory sessions where alcohol or placebo will be administered intravenously using     a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc)     method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple     outcome measures including subjective, motor, cognitive measurement and plasma cytokine     levels.   "
83955|NCT02187198|"     This is a randomized, open-label clinical trial with 200 Veteran opioid dependent men and     women. Veterans will be randomized to one of two treatment groups: low dose range of     buprenorphine (<8mg) vs. high dose range of buprenorphine (<16mg). During induction into     buprenorphine, all participants will be started at a dose of 2mg, and this dose will be     increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low     dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will     be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of     the 12-week study, participants will either be referred to a buprenorphine clinic if they     wish to continue this medication, or if they wish to be drug free, will undergo     detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at     1, 3, and 6 months after study completion, will evaluate the durability of treatment effects     on drug use and psychosocial outcomes. Veterans will be recruited primarily through     advertisement, but also through the clinical facilities at the VA and from other     collaborators.   "
83956|NCT02187185|"     This research study has 2 aims. One aim is to see if saliva testing can show if a person has     healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or     severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on     periodontitis.   "
83957|NCT02187172|"     The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab     (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers     in patients with moderate to severe psoriasis.      This study will look for systemic vascular inflammation in study participants with a test     called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The     study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in     blood samples, including markers of high cholesterol, cholesterol efflux function (the     ability of cholesterol to move in the body), metabolic factors, and inflammation.      The study will also examine the effects of ustekinumab compared to placebo on psoriasis     activity, severity and safety.   "
83958|NCT02187159|"     The main objective of this trial is to compare change in weekly average daily pain score     (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo.     Weekly ADPS is based on daily pain scores reported by the subject that best describes his or     her worst pain over the previous 24 hours.   "
83959|NCT02187146|"     The purpose of this study is to investigate whether an association exists between serum     vitamin D levels and IVF treatment outcome   "
84017|NCT02186275|"     The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the     outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity,     in children with newly diagnosed Crohn's disease (CD).   "
83960|NCT02187133|"     This study will be conducted as a Phase Ib, open-label, non-randomized, single-institution     study to evaluate the safety and tolerability of carfilzomib in combination with bendamustine     and rituximab in patients with relapsed or refractory NHL and to determine the recommended     phase II dose and preliminary efficacy of this combination. The study will have two phases: a     dose-escalation phase to determine the maximal tolerated dose of carfilzomib in this     combination where participants will be monitored for toxicity, tolerability and response and     a dose-expansion phase that will determine the preliminary efficacy in patients with Mantle     cell lymphoma or any other disease subtype in which there is a preliminary efficacy signal     observed.      Determination of the maximum tolerated dose (MTD) will follow standard 3+3 design with     escalation of the carfilzomib dose only. Dose levels of carfilzomib will be 20 mg/m2, 36     mg/m2, 56 mg/m2, and 70 mg/m2 IV administered weekly on days 2, 9 and 16. The last 3 cohorts     will have a starting carfilzomib dose of 20 mg/m2 on days 1, 2. Bendamustine will be     administered at the well-tolerated dose of 90 mg/m2 IV on days 1 and 2. Rituximab will be     given at a dose of 375 mg/m2 on day 9 of Cycle 1 and day 1 of subsequent cycles. Rituximab     will be intentionally delayed to day 9 of cycle 1 to help facilitate performance of the     correlative studies.   "
83974|NCT02186951|"     Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with     shockable rhythm. In mechanically ventilated patients who were resuscitated after     out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for     infectious complications and especially for ventilator-associated pneumonia (VAP).      Despite high incidence of VAP and other infectious complications, it is not currently     recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could     be decreased if an antibiotic therapy was systematically given to patient treated with mild     therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less     infectious complications but also decreased morbidity and mortality related to these     complications when antibiotic therapy was given early to patients treated with therapeutic     hypothermia after cardiac arrest.   "
83961|NCT02187120|"     The purpose of this research is to determine whether giving severely injured adults a drug     called tranexamic acid (TXA) as soon as possible after injury will improve their chances of     survival and their level of recovery at six months.      After severe injury, a person may have uncontrolled bleeding that places them at high risk of     bleeding to death. Coagulation (the formation of blood clots) is an important process in the     body that helps to control blood loss. Up to a quarter of people that are severely injured     have a condition called acute traumatic coagulopathy. This condition affects coagulation and     results in the break down of blood clots (fibrinolysis) that can lead to increased blood loss     and an increased risk of dying.      TXA is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic     coagulopathy by preventing blood clots from breaking down and helping to control bleeding. In     Australia, TXA is approved for use by the Therapeutic Goods Administration (TGA) to reduce     blood loss or the need for blood transfusion in patients undergoing surgery (i.e. cardiac     surgery, knee or hip arthroplasty). Recent evidence from a large clinical trial (CRASH-2)     showed early treatment with TXA reduced the risk of death in severely injured patients,     however the majority of patients involved in the study were injured in countries where     prehospital care is limited and rapid access to lifesaving treatments is limited compared to     that available in countries like Australia and New Zealand. It is unclear whether TXA will     reduce the risk of death to the same degree when it is given alongside other lifesaving     treatments that are available to patients soon after injury in these countries.      The hypothesis is that TXA given early to injured patients who are at risk of acute traumatic     coagulopathy and who are treated in countries with systems providing advanced trauma care     reduces mortality and improves recovery at 6-months after injury.   "
83962|NCT02187107|"     The purpose of this study was primarily to assess the long-term safety and tolerability of     TMC114/rtv in addition to an individually optimized background antiretroviral therapy in     HIV-1 infected participants. In addition, antiviral activity and immunological effect were     also evaluated.   "
83963|NCT02187094|"     Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic     disorder that slows or stops the passage of food from the stomach to the small intestine. The     purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric     emptying time in diabetic subjects with gastroparesis.   "
83964|NCT02187081|"     Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in     diameter. However, the long-term prognosis is not satisfactory due to the high incidence of     recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with     locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug     associated with improved overall survival (OS) in patients with advanced HCC. Retrospective     and randomized studies have suggested that the combined use of Sorafenib may be useful in     patients with unresectable HCC. Based on these information and the multiple actions of     Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early to     Mid term HCC. In this investigation, we evaluated the safety and efficacy of a combination     Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1     HCC in a multicenter prospective cohort study.   "
83965|NCT02187068|"     The aim of this study is to characterize, using two different modeling approaches, one based     on purely statistic concept and one using a more mechanistic analysis, the influence of body     weight and composition on the pharmacokinetic of dexmedetomidine.   "
83966|NCT02187055|"     To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as     compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy     compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes     measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab.     To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or     adalimumab.   "
83967|NCT02187042|"     220 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib     (Sutent) will be randomized into two arms :        -  Control arm: Followed with standard care        -  Experimental arm: Followed with standard care plus a call center      Principal assumption : reduce the percentage of adverse events of grade 3, 4 by 20% between     the control arm (60%) and the experimental arm.   "
83968|NCT02187029|"     The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid     in subjects suffering from gout following 14 days of dosing, as well as assessing safety and     tolerability.   "
83969|NCT02187016|"     The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal     cleaning modalities with and without chemistry on oral health over 28 days.   "
83970|NCT02187003|"     This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in     treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing     a pain crisis necessitating hospitalization.   "
83973|NCT02186964|"     Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen     in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is     found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.      There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in     between those methods is the closing of the defect that occurs after the excision of the     sinus tract. The defect can be closed by primary sutures or it can be left for secondary     healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap     procedures are commonly used. However, it has been reported that there is no difference     between flap procedures and tension free primary closure. This result triggered the     controversy that; if the healing side is tension free, midline suturing may have no     importance. The aim of this study is to compare the results of 3 different surgical     procedures used in treatment of pilonidal disease.   "
83975|NCT02186938|"     This study aims to investigate whether the intraoperative use of the FloTrac device to guide     fluid and vasopressor management during head and neck free flap surgery improves     postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary     postoperative outcomes include days in ICU, days on ventilator, presence of postoperative     pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap     complication rate, inpatient postoperative cardiorespiratory complications/events, and     overall 30 day flap failure rate.   "
83980|NCT02186873|"     The purpose of this study is to evaluate the efficacy of intravenously (administration of a     fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants     with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that     involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral     joints).   "
83981|NCT02186860|"     Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for     fighting cancer. Many people do not respond to the standard treatments of ALL. One possible     treatment is chimeric antigen receptor (CAR) modified T cell infusions. Third generation     CAR-T which contains Cluster of Differentiation 28 (CD28) and Cluster of Differentiation 137     (CD137) has stronger effect of anti-tumor capacity compare with second generation CAR-T. The     investigators believe that the cells with CD28 and CD137 will have a better chance of killing     the lymphoma cells. In the lab, the investigators constructed a third generation CAR     containing both CD28 and CD137. The investigators start Phase I study aimed to chemotherapy     resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is     to assess the safety and effectiveness of third generation CAR-T cells in patients.   "
83982|NCT02186847|"     This randomized phase II trial studies how well chemotherapy and radiation therapy given with     or without metformin hydrochloride works in treating patients with stage III non-small cell     lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy     x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and     keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is     more effective when given with or without metformin hydrochloride in treating stage III     non-small cell lung cancer.   "
83983|NCT02186834|"     The main purpose of this study is to see whether the combination of Selinexor (KPT-330),     liposomal doxorubicin and dexamethasone can help people with relapsed and refractory Multiple     Myeloma. Researchers also want to find out the combination of Selinexor (KPT-330), liposomal     doxorubicin and dexamethasone is safe and tolerable.   "
83984|NCT02186821|"     The purpose of this signal seeking study is to determine whether treatment with ceritinib     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic     malignancies to warrant further study.   "
83985|NCT02186808|"     The objective of the study is to evaluate the clinical performance of Procera® Bridge     Zirconia veneered with NobelRondo Zirconia.   "
83986|NCT02186795|"     The goal of this retrospective chart review is to evaluate if the implementation of lumbar     plexus block placement for postoperative pain and administration of multimodal oral analgesia     have improved conditions in the postoperative period for patients undergoing total hip     arthroplasty when compared to the placement of epidurals for postoperative pain management.   "
83987|NCT02186782|"     The purpose of this study is to evaluate the effect of concomitant administration of     estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile     women.   "
83988|NCT02186769|"     A review of the amount of drug in your blood over time.   "
83989|NCT02186756|"     The purpose of this study is to determine whether EMG-Biofeedback is effective in the     treatment of Fibromyalgia.   "
83990|NCT02186743|"     The primary objective of the clinical trial portion of this study is to assess whether an     individualized dietary plan based on a commercial food sensitivity assay provides specific     benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).   "
83995|NCT02186678|"     18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and     Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as     dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine     Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography)     imaging using peptide receptors has gained an increasing role in the management of NETs. The     use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of     Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of     SSTRs-expressing tumors, including PGLs.      In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than     other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the     most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and     68Ga-DOTATATE PET-CT have never been compared in this clinical setting.   "
83996|NCT02186665|"     The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to     8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice     daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.   "
83997|NCT02186652|"     Multicenter, comparative single-dose pharmacokinetic (PK) study   "
83991|NCT02186730|"     This study forms the second phase of previous work to examine the effectiveness of     computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low     mood/depression.      Depression affects around 2% of adolescents. Antidepressants are not recommended for this age     range as a first line treatment because of concerns about their usefulness and side effects.     Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which is     effective and one of the main treatments recommended for depression. It has been suggested     that computerised versions of CBT (cCBT) may be effective for treating depression in young     people who may prefer this to seeing a therapist face-to-face, but little research exists to     date to support this. This study examines the feasibility of running a large scale randomised     controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with self-help     websites for adolescents with low mood and depression (LMD).      Eligible and consenting participants will complete several questionnaires to assess their     mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to     selected websites providing self help for LMD. Participants will complete further mood     questionnaires 4 and 12 months after treatment completion/withdrawal. We have already     recruited 97 individuals to this trial but aim to recruit a further 48 participants to     collect further information.      We are also keen to find out whether sending participants text messages before sessions and     around follow up periods will increase attendance/completion. Therefore all trial     participants will receive text messages from the research team during their participation.   "
84003|NCT02186574|"     The purpose of the study is to determine how effective preemptive tenofovir therapy is in     preventing the re-activation of Hepatitis B infection, in patients who are receiving     rituximab-based chemotherapy for Non-Hodgkin's Lymphoma. The rate of re-activation will be     compared between patients who receive preemptive tenofovir and patients who receive tenofovir     as needed.   "
84004|NCT02186561|"     The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device     in the treatment of unruptured, wide-neck intracranial aneurysms.   "
84117|NCT02184975|"     The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined     according to the colposcopic evaluation of the patient. In case colposcopy findings are     satisfactory (visible squamocolumnar junction), both ablative and excisional methods are     adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the     cold knife conization surgical technique to reduce blood loss. Some authors recommend that     these branches should be ligated, but it remains unclear whether these sutures are actually     effective in reducing bleeding.This study compared blood loss during cold knife conization of     the cervix with and without lateral hemostatic sutures.   "
83992|NCT02186717|"     The specific aim of this prospective, randomized controlled trial is to compare the effect of     chewing gum on the return of bowel function in a group of patients undergoing spinal surgery     with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in     time to passage of first flatus will be considered an important clinical difference.      The research questions are:        1. Does providing chewing gum post-operatively hasten the return of bowel function?        2. Does providing chewing gum post-operatively reduced overall length of stay?        3. Does providing chewing gum post-operatively have any associated complications?        4. Does providing chewing gum post-operatively result in higher objective outcomes scores?      The secondary aims are:        1. To compare hospital length of stay between the groups with a mean of ½ day considered          clinically important.        2. To compare time until tolerating regular diet as defined as two consecutive meals with          no complications with 24 hours considered statistically significant.        3. To compare incidence and nature of complications between the two groups.        4. To compare the time until completion of rehab milestones with 1 day being considered          clinically important.        5. To compare the requirement for nutrition evaluations        6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10          points or more measured between the two groups upon discharge from hospital and at          six-weeks after surgery.   "
83993|NCT02186704|"     The primary aim of the Sensing Atrial High Rate Episodes with DX System in Implantable     Cardioverter Defibrillators Trial (SENSE Trial) is to assess the efficacy of a implantable     cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting     atrial high rate episodes.      The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles     will have a diagnostic yield comparable to that of a standard dual chamber ICD system and     superior to that of a standard single chamber ICD system.   "
83994|NCT02186691|"     Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at     35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or     pulmonary regurgitation (PR). It is well established that these lesions can lead to     irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve     replacement technique was developed to avoid long term right ventricular dysfunction.     Pulmonary valve replacement indications are based upon the presence of symptoms at exercise     and/or morphological or functional parameters such as severe pulmonary regurgitation with     right ventricle dilatation/dysfunction. The best timing of such intervention is still     underdebate with the main aim of having the right balance between avoiding long term sequelae     of PR or PS and being the latter possible to push ahead the need for new intervention. Recent     publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration     of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging     is feasible and could help the physician to best determine the right timing for PVR in this     population of patients. Cardiac function assessment at rest and during exercise is possible     using MR and our centre has developed a program for cardiac exercise during MRI. This could     help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.   "
83998|NCT02186639|"     To answer the question whether a disease specific profile of breath in patients with COPD can     be detected by an untargeted metabolomic study using exhaled breath analysis by mass     spectrometry.   "
83999|NCT02186626|"     West Nile virus (WNV) is considered an emerging virus in the United States, and infection can     lead to severe illness in older adults. This study will evaluate the safety of and immune     response to a live West Nile virus vaccine (WN/DEN4Δ30) for the prevention of West Nile     encephalitis in adults 50 to 65 years old.   "
84002|NCT02186587|"     To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the     outcomes of patients who receiving an off-the-shelf total knee implant.      Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data,     and implanted with CT-navigated custom instruments will show faster functional recovery,     including gait and patient functional outcome scores, when compared to standard,     off-the-shelf total knee components inserted with non-navigated instruments (the present     standard of care in total knee surgery).   "
84610|NCT02178540|"     The purpose of this actual use human factors (HF) study is to validate the approved US TOBI     Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates     the information necessary to achieve safe and effective use of the Podhaler device.   "
84005|NCT02186548|"     Permanent canines in the maxilla usually erupt into the mouth at 11-12 years of age. In     approximately 2% of the Swedish population they fail to erupt, and are then referred to as     impacted. One severe complication of impacted maxillary canines is damage (root resorption)     to the roots of adjacent teeth. The root resorption may be so severe that neighboring teeth     are lost. If the impaction is detected early (at 9-10 years of age), the recommended     treatment is to extract the deciduous canine, to help the permanent canine to resolve its     unfavorable position. If there is no improvement of the position of the canine 1 year after     the extraction, surgical and orthodontic treatment is indicated. Surgical exposure is     followed by orthodontic treatment with fixed appliance for 2 to 3 years to bring the canine     into correct position.      Two different main principles of surgical exposure in palatally impacted maxillary permanent     canines are the so called closed versus open surgical techniques.      Closed technique involves surgically uncovering of the canine with a mucoperiosteal flap     dissected off the bone. The bone covering the canine is being removed and an attachment with     a chain is bonded to the tooth. The flap is repositioned and sutured back with the chain     above the mucosa. Shortly after the surgery, orthodontic force is applied via the chain. The     canine is orthodontically moved beneath the palatal mucosa by forced eruption.      Open technique involves surgically uncovering of the canine, removing a window of tissue     around it and placing pack to cover the exposed area. Then the treatment approaches vary     depending on whether the attachment with a chain is bonded to the exposed tooth at surgery or     if spontaneous eruption of the palatally impacted canine is expected postsurgically. In both     alternatives orthodontic force is applied via the chain and the canine is orthodontically     moved above the mucosa. These two techniques of surgical exposure of palatally impacted     canines seem to be the two routinely used in Sweden.      The purposes of this study are to examine, describe and compare the treatment outcomes in     regard to success and duration of treatment, complications, side effects, cost-benefit     aspects and patients´ perceptions in closed versus open surgical exposure techniques, in     cases with palatally impacted canines.      The objective is to test the null hypothesis that there are no differences in the above     outcomes between open or closed surgical exposure of palatally impacted canines.   "
84006|NCT02186535|"     The purpose of this study is to assess the impact of approximately 8 weeks of Vitamin D     (VitD) and calcium supplementation, using daily versus weekly supplementation regimens, on     female reproductive tract immunity.   "
84007|NCT02186522|"     Patients admitted to intensive care units (ICU) are at high risk of developing secondary     infections, and this is in part due to dysfunction or failure of their 'germ killing'     functions (the immune system). Our group has recently identified three signatures of immune     system failure which can be readily detected on a blood sample, and importantly, appear to     predict the chances of developing secondary infection. Such a test would have major benefits     for the management of patients in intensive care if it can be translated into a test usable     in everyday clinical practice. This study aims to validate our original findings in a cohort     of patients from multiple ICUs, using a test which will be suitable for everyday clinical     practice, and thus take the next step towards developing a market-ready test.      Study hypothesis:      Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict     the risk of nosocomial infection.   "
84008|NCT02186509|"     This phase I trial studies the side effects and best dose of alisertib when combined with     fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have     returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the     growth of tumor cells by blocking an enzyme needed for the cells to divide. Radiation therapy     uses high energy x rays to kill tumor cells. Stereotactic radiosurgery uses special     positioning equipment to send a single high dose of radiation directly to the tumor and cause     less damage to normal tissue. Delivering stereotactic radiosurgery over multiple doses     (fractionation) may cause more damage to tumor tissue than normal tissue while maintaining     the advantage of its accuracy.   "
84009|NCT02186496|"     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330     (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the     two separate drugs in healthy male volunteers.   "
84010|NCT02186483|"     The purpose of this study is to investigate the pharmacokinetic drug interaction between     Metformin and Rosuvastatin in healthy male volunteers.   "
84011|NCT02186470|"     This clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI)     before surgery in treating older patients with estrogen receptor positive or negative and     progesterone receptor positive stage 0-I breast cancer. APBI is a specialized type of     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery     may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.   "
84012|NCT02186457|"     The purpose of this study is to determine if the routine use of antibiotic irrigation during     pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.   "
84013|NCT02186444|"     The purpose of this study is to evaluate the impact of providing newly diagnosed prostate     cancer patients and their caregivers with an interactive mobile tablet technology-based     application delivered by a community navigator versus providing National Cancer Institute     (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes     (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared     decision making practices (decision making involvement).   "
84014|NCT02186431|"     To quantify and compare baseline tear proteins and ocular response in contact lens wearers     with a history of corneal infiltrative events, to those without a history of complications.     This will be accomplished via measurement of select anti-inflammatory tear proteins before,     during and after contact lens wear.   "
84015|NCT02186301|"     The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with     erlotinib in patients whose tumors have specific EGFR mutations and who have not previously     received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a     'Randomized' Study. This means that upon entering the study, patients will be randomly     assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients     will continue to take either rociletinib or erlotinib until it is no longer beneficial.   "
84016|NCT02186288|"     Effect of High-flow nasal cannula oxygen on end-expiratory lung volumes determined by     electrical impedance tomography   "
84118|NCT02184962|"     The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their     relationship in gingival crevicular fluid of post-menopausal women with     osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that     the use of bisphosphonates in periodontal disease.      Study hypothesis:      The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease     affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis     processes    "
84018|NCT02186262|"     Grading of gliomas is of significant clinical importance since the prognosis as well as the     treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI     modalities, however, a reliable distinction is often impossible. Moreover, the gold standard     for glioma grading by histopathology may also have limitations due to unrepresentative tumor     samples. Therefore, more advanced MRI techniques are urgently needed that would have higher     sensitivity and specificity in the definition of tumor type, grade and extent.      Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria     12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify     nonresponding patients earlier, preferentially midtreatment in order to consider alternative     treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have     provided promising results in assessing early treatment response. Furthermore, a serum     biomarker with diagnostic value could improve tumor follow-up and clinical management of     gliomas.      The aim of our study is to develop novel imaging protocols suitable for the magnetic     resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame     imaging, novel DWI acquisition and post-processing methods We also study the correlation     between advanced MRI parameters and histopathology of the tumor specimen. In addition, early     treatment response is assessed with advanced MRI parameters at 3 week and 10 week after     initiation of radiotherapy. Finally, our objective is to study the association between serum     biomarkers and corresponding MRI with potential tumor progression.   "
84019|NCT02186249|"     The purpose of this study is to provide treatment with nivolumab in combination with     ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have     unresectable or metastatic melanoma.   "
84020|NCT02186236|"     The purpose of this study is to see whether gene mutations can be found in the urine or blood     of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA     in a gene is damaged in a way that changes the genetic message carried by that gene. Gene     mutations can sometimes cause lung cancers. These gene mutations are only found in lung and     colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and     colorectal cancer tumors are now tested for different gene mutations as their presence     affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically     tested for these gene mutations.   "
84021|NCT02186223|"     The primary objective of this multicenter, prospective, single arm clinical trial is to     evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE,     and with recognized contraindications to standard pharmacological therapy (anticoagulation).   "
84022|NCT02186210|"     Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial     injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery     without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is     important for clinical outcome. The investigators hypothesized that prewarming during     induction of general anesthesia would reduce drop of body temperature and change of     peripheral microcirculation.   "
84023|NCT02186197|"     Shock and respiratory failure are common reasons for admission to the intensive care unit     (ICU) at our institution. The various causes of acute shock and respiratory failure are     traditionally assessed with the use of history, physical examination, chest x-ray, EKG and     laboratory studies. Unfortunately, much of this clinical information is either insensitive or     non-specific. 1 Critical care ultrasound (CCUS) is a rapid and non-invasive tool, which has     been shown to be useful in the intensive care unit to assist in the diagnosis and management     of patients in shock or respiratory failure.2      The investigators hypothesize that the trained fellow's interpretation of critical care     ultrasound images will be accurate when compared to experts and that ultrasounds will change     diagnosis and management of the patient in shock and respiratory failure.   "
84024|NCT02186184|"     Orthokeratology is becoming popular for the treatment of myopia children. Many studies have     shown that orthokeratology is effective in temporarily reducing refractive error, and is also     helpful for controlling myopia progression. However, the mechanism for its slowing myopia     progression and rebound effect after the treatment have not been clearly studied. In     addition, the effect of orthokeratology among Chinese children has not been evaluated with     randomized controlled trial.This study is to assess the effect of orthokeratology versus     spectacles on myopia progression in school-aged Chinese children during two years.   "
84025|NCT02186171|"     This is a phase 3 multicenter study to compare the efficacy and safety of Romosozumab (AMG     785) with placebo in men with osteoporosis.   "
84026|NCT02186158|"     Pneumonia is the second common infection and its risk increases for elderly. In this     population, it is the first cause of mortality by infections, and source of many     complications. Geriatric studies had shown the high prevalence of ascorbic acid 's     deficiency, especially in older hospitalized people. It is well known that vitamin C is one     of the key of the immune system, it has a scavenger's role in case of aggression like sepsis.     A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and     treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for     patients treated by vitamin C, and for one of those studies it was noted a significant     reduction of mortality. The main objective of our study is first to determine the impact on     respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in     older people hospitalized, and then evaluate its impact on functional status.   "
84027|NCT02186145|"     The purpose of this study is to evaluate the efficacy and safety of association of     metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal     infections.   "
84038|NCT02186002|"     The primary objective of the study was to evaluate the safety and tolerability of ACT-451840     in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK)     of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the     urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.   "
84076|NCT02185508|"     The purpose of this study is to determine the relation among: (1) changes in voltage and     amplitude of trans-operatory records obtained through the use of Intra-operative     Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1     or 2 levels surgical decompression at lumbar spine.      IONM is the use of real time neurophysiological techniques during spinal surgeries. The     modalities included in this study are:        -  Somatosensory evoked potentials (SSEPs).        -  Trans-cranial electric motor evoked potentials (tceMEPs).        -  Spontaneous electromyography (EMG).      Clinical outcome of the patients will be assessed through a careful evaluation of clinical     data, as well as the application of three outcome scales:        -  Oswestry Disability Index 2.1a        -  Visual Analogue Scale for Pain        -  Patient's Overall Impression of Change   "
84028|NCT02186132|"     Balanced general anesthesia with neuromuscular blocking agents has been widely used for     surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular     blocking agents with several adverse effects such as bradycardia and profuse secretion.     Atropine has been used to prevent those side effects of neostigmine. The routine dosages of     the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.      Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with     2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was     increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the     mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of     atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm.     However this study did not report the incidence of bradycardia and blood pressure. The mean     heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)      Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of     neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest     heart rate at 40 minutes after administration. This study also did not report the blood     pressure.      The baseline heart rate (HR) before administration of the reversal was associated with the     following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after     receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of     pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients     receiving alcuronium. However, before administration of atropine and neostigmine, the mean     heart rate of patients was significantly lower in the pancuronium group.      Either tachycardia or bradycardia with hypotension causes adverse affect to patient     especially in specific group like patient with coronary artery disease or undergoing     craniotomy.      The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood     pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant     compare to 1.2 mg atropine.   "
84029|NCT02186119|"     This is a safety and efficacy study of abicipar pegol in patients with diabetic macular     edema.   "
84030|NCT02186106|"     Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our     objective was to determine how to calculate the quantity of cholecalciferol needed for     supplementation by single algorithm, usable on a patient-to-patient basis.      We've conducted two studies. Study 1 was done retroactively and included 88 patients treated     for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and     aimed to test the validity of an algorithm based on data from study 1, which included patient     BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.   "
84031|NCT02186093|"     There are several physiologic parameters in evaluating cardiovascular disease. This study     will reveal which parameter is the most proper value in predicting disease severity and risk     factors of patients.   "
84032|NCT02186080|"     This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes.     The investigators will measure systemic endotoxin level and lipid level after ingestion of     high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic     endotoxemia and lipemia induced by high fat diet.   "
84033|NCT02186067|"     Hypertension has become a public health concern worldwide due to its significant contribution     to the global health burden and its role as a prominent risk factor for the development of a     number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of     mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is     attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for     57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.      Studies suggest that hypertension is among the top five most common presenting complaints to     private general practice clinics. Therefore, primary care physicians/Family physicians are     the first line service providers and; thus it is important to manage hypertensive patients     early, through lifestyle and treatment interventions that may prevent the complications such     as development of CVDs etc.   "
84034|NCT02186054|"     The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to     see how they compare to previously used imaging sequences as they may improve the quality of     abdominal MRI.   "
84035|NCT02186041|"     The purpose of this study is to document the safety, the effectiveness, the continued     performance at mid and long term, the morbidity and the percent of surgical revisions of the     Interstim® therapy for up to 5 years in a representative sample of French centers under     real-life conditions of use.   "
84036|NCT02186028|"     The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin     D on serum Vitamin D levels in term healthy newborns. It has been found in various studies     that vitamin D is highly deficient in Indian mother infant diads. There is a need to     supplement vitamin D from neonatal period to prevent various metabolic disturbances due to     vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum     dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal     requirements in Indian infants.   "
84037|NCT02186015|"     Background: Several clinical trials are underway to investigate if variable forms of vitamin     D (D2 vs. D3) prescribed at different doses (10,000-50,000 IUs/week) can improve the     side-effects associated with treatment for estrogen receptor positive (ER+) breast cancer,     specifically aromatase inhibitors (AIs.) Presumably for generalizability and potential safety     purposes, these trials predominantly exclude women with metastatic breast cancer (MBC); a     rapidly expanding sector of the cancer survivor population who experience significant     treatment-related side-effects. Evaluation of the safety of vitamin D3 supplementation is     crucial since supplementation can lead to high calcium and importantly, in lab studies have     shown that vitamin D3 affects a gene that increases estrogen production. To assure that     vitamin D3 does not affect the clinical effects of anti-estrogen therapies, the effect of     vitamin D3 supplements on estrogen production requires an evaluation that further explores     and defines its potential role in symptom management for this population.      Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in     women with MBC, providing much needed data on the preliminary safety and efficacy of this     treatment in this patient population. This study will determine: 1) if weekly supplementation     of high dose vitamin D3 increases serum vitamin D levels without adverse effects related to     such therapy (primary aim); 2) the effects of vitamin D3 supplementation on symptom     management (secondary aim); and 3) if vitamin D3 supplementation is associated with improved     inflammation (exploratory aim.)      Methods: This is an 8 week proof of concept study to monitor important laboratory     parameters and to assess potential effects on short-term outcomes. Adult, female patients     (>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D < 30     mg/dl will be recruited from within and around LUMC. Following current clinical practice     guidelines, eligible participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks.     Laboratory values, muscle function and inflammation will be examined pre- and     post-supplementation, while symptoms (e.g., pain, sleep, fatigue, mood, and overall quality     of life) will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if     increases in vitamin D are associated with clinically significant changes in serum estradiol,     improvements in symptoms and QOL, and decreased inflammation, controlling for sunlight     exposure, diet, physical activity and body composition.   "
84039|NCT02185989|"     Early mobilization (from the first day if possible), first passive and then passive and     active, is recommended for critically ill patients in whom it reduces the duration of     mechanical ventilation, the length of hospital stay, improves functional status, muscle     strength and quality of life after hospital discharge. The early addition of leg bicycling on     a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve     muscle strength and further increase the beneficial effects of early mobilization. Electrical     muscle stimulation of the quadriceps, is practiced in some intensive care units, and it     should, in theory, also through an improvement of muscle strength, increase the beneficial     effects of early mobilization.      We hypothesized that early quadriceps electrical stimulation and early work on a     cyclo-ergometer associated with a standard protocol of early passive/active mobilization in     the ICU may improve muscle function and reduce the duration of mechanical ventilation, length     of stay, the number of readmissions and improve the quality of life in the mid term in     critically ill patients, as compared to a conventional protocol of early passive/active     mobilization.   "
84040|NCT02185976|"     Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a     special group who need special attention. Some studies have shown that cartoons are a very     good tool for distraction in the preoperative period for children.      Our hypothesis is that children watching Cartoons in the preoperative period will have less     anxiety and will be fit with preparation.   "
84041|NCT02185963|"     The patients who have achieved LDL-C levels below the currently recommended targets may still     experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD),     raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased     HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether     functional HDL is more important than total circulating levels of HDL-C in reducing CHD.      Actually, the increased concentration of HDL alone might be ineffective indicating that     qualitative changes in HDL levels in response to drug interventions are required to result in     clinical benefit.      The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on     functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.   "
84042|NCT02185950|"     Burning produces changes in the biomechanical properties of the skin causing limitation of     movement. The increase in skin suppleness is very important in the rehabilitation process,     since its increase makes therapeutic interventions aimed at increasing the range of motion,     thus improving functional pattern. Will be evaluated 60 volunteers of both sexes aged 20-80     years seen at the Burns Unit of the Clinical Hospital of the Faculty of Medicine of Ribeirão     Preto. There will be a traditional physical therapy evaluation as well as evaluation of the     specific characteristics of the burn and scar. The temperature of the region will be assessed     by thermography, and biophysical parameters and biomechanical skin evaluated by Cutometer and     their accessory probes (mexameter, reviscometer, sebometer) before, immediately after and 10,     20 and 30 minutes of application of therapeutic resources. Volunteers will undergo continuous     application of ultrasound with 3 MHz and intensity of 1 W/cm2 in the region due to scar deep     second degree burn or third degree, and the application time of 2 minutes for each effective     radiation area of the head (ERA) in a predetermined region of 9X5 cm a total of 4 minutes of     application, therapy paraffin 20 minutes and 4 minutes endermology negative pressure between     100 and 200mmHg, in a continuous mode with glass head (1.5cm in diameter .) Applications will     be set by random draw (design crusader cross-over) with an interval of 7 days between     applications (wash-out). The data will be submitted to analysis of normality by the     Shapiro-Wilk test, and the behavior of the effect between groups and pre-and     post-intervention will be evaluated by two-way ANOVA followed by post-hoc (Bonferroni) or     Friedman, p <0.05   "
84043|NCT02185937|"     The most common sites for GIST to occur are the stomach (60-70%) and proximal small     intestines (20-25%). Therefore patients with GIST often have altered GI-tract due to tumor     resection or palliative surgery which might affect imatinib exposure. Indeed, Yoo et al.     showed that steady state imatinib trough levels in patients with advanced GISTs after major     gastrectomy are lower compared to patients with a previous wedge resection or without gastric     surgery. Patients that underwent major gastrectomy had an average imatinib plasma trough     levels below 1000 µg/L. This while imatinib trough levels above 1000 µg/L are correlated to     more beneficial treatment out-comes (longer Progression Free Survival).      Since imatinib easily and rapidly dissolves at pH 5.5 or less, a lack of gastric acid     secretion might be causing the decreased exposure in the patients that underwent major     gastrectomy.      Therefore the investigators would like to study if the exposure to imatinib in patients after     major gastrectomy can be improved by creating a more acidic environment for absorption     through combining imatinib intake with Coca-Cola.   "
84044|NCT02185924|"     Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine     consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores,     transfusion requirements , Range of motion and rehabilitation parameters between two groups   "
84045|NCT02185911|"     To describe anaemia correction via haemoglobin measurements taken throughout observation     period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM   "
84046|NCT02185898|"     This study will assess environmental emissions of selected compounds in a test chamber after     cigarette smoking or e-cigarette vaping.   "
84078|NCT02185482|"     There is a high prevalence of depression in patients with diabetes mellitus. Depression has     been shown to be associated with poor self-management (adherence to diet, exercise, checking     blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality     physician's care for depression improves both depression and diabetes outcomes in patients     with depression and diabetes.   "
84079|NCT02185469|"     There are multiple ways to treat retinal detachment, the aim of this study is to compare the     amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to     vitrectomy.   "
84131|NCT02184793|"     Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of     bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in     those patients. However, such a bed inclination frame is still difficult to maintain in     day-to-day care.      The aim of the study is to evaluate the impact of an electronic monitoring device on the     proportion of time spent per day in semi-recumbent position, as defined by a head of bed     inclination between 40° and 50°, in mechanically-ventilated patients.   "
84047|NCT02185885|"     STUDY HYPOTHESIS      In cardiac surgery the volume of perioperative cerebral infarctions can be reduced by     increasing mean arterial pressure (MAP) during the cardiopulmonary bypass procedure.      BRIEF STUDY SUMMARY      Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain.     Previous studies using brain scans have reported small stroke-like lesions in up to 51% of     patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of     severe brain damage.      The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in     blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow to     areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB     usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since     sufficient total blood flow is guaranteed during CPB.      The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or reduce     the extent of brain injury after cardiac surgery. A beneficial effect could result from     reduced embolic injury through increased blood flow in collateral vessels and/or by increased     blood flow in calcified arteries.      180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP (70-80     mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow is     intended equal and fixed in the two groups. Patients are examined before and 3-6 days after     surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood borne     markers of brain injury.      If higher MAP during CPB is beneficial, a change of practice can easily be implemented in the     clinical routine.   "
84048|NCT02185872|"     The purpose of this study was to examine the differences in glucose control, fitness, and     body composition between a standard aerobic and resistance exercise training program and a     shorter-duration, high-intensity CrossFit training program in overweight and obese physically     inactive adults.      Hypotheses:        1. Both groups would improve glucose control, with the CrossFit group improving          significantly more than the aerobic and resistance training group.        2. Both groups would improve fitness, with the CrossFit group improving significantly more          than the aerobic and resistance training group.        3. Both groups would demonstrate decreases in body fat percentage and fat mass and          increases in lean body mass, with the CrossFit group improving significantly more than          the aerobic and resistance training group.   "
84049|NCT02185859|"     Postsurgical pain is a relevant side effect following surgery which increases the risk of     various complications and delays postoperative patient recovery. Among the many types of     surgeries, mastectomy causes not only acute but also chronic pain in many patients.     Therefore, it is important to control pain and increase patients' recovery satisfaction     following many kinds of operations by using as small an opioid analgesic dose as possible and     adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among     nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be     helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical     stimuli. An intraoperative intravenous injection of lidocaine has been reported to improve     postoperative pain control by reducing postoperative pain and opioid consumption. Another     report showed that an intraoperative intravenous injection of lidocaine improved the quality     of postoperative functional recovery after general anesthesia in a laparoscopic     cholecystectomy patient. In addition, a review article on the effect of intraoperative     intravenous injection of magnesium found it to be an effective analgesic that may be added to     conventional opioid-based therapy because it generally reduces opioid consumption, decreases     pain assessment for 24 hours after surgery, and lacks severe side effects in relation to     magnesium administration. However, there has been insufficient research comparing the     intraoperative intravenous injection of lidocaine or magnesium in terms of which is more     helpful for general functional recovery and decreased postoperative pain. Recently, the scope     of research on anesthesia has come to embrace postanesthetic recovery; to help patients     return to daily life, the research trend is now shifting from the improvement or resolution     of a specific symptom to the measurement of general recovery. A widely used method to measure     postoperative recovery is the Quality of Recovery 40 (QoR-40) survey.      Therefore, in this study, the researchers investigated the intraoperative intravenous     injection of lidocaine and the intravenous injection of magnesium to compare these drugs'     helpfulness in the functional recovery of mastectomy patients after general anesthesia.   "
84050|NCT02185846|"     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE     products by measurement of Plasma concentrations of Erythromycylamine and calculation of the     bioequivalence parameters from those measurements followed by ANOVA and 90% confidence     interval statistical evaluation.   "
84051|NCT02185833|"     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE     products by measurement of Plasma concentrations of Erythromycylamine and calculation of the     bioequivalence parameters from those measurements followed by ANOVA and 90% confidence     interval statistical evaluation.   "
84052|NCT02185820|"     This protocol is a phase I/II multicenter study designed to assess the safety and the     efficacy of the proposed combinations in relapsed and/or refractory Multiple Myeloma (MM)     patients.   "
84053|NCT02185807|"     The investigators will investigate whether video-assisted informed consent is superior to     routine discussion for cataract patients about risks, benefits and alternatives to receiving     phacoemulsification cataract extract and intraocular lens implantation, and will determine     whether video-assisted informed consent can reduce the work load of physicians.   "
84054|NCT02185794|"     This study will evaluate the safety, tolerability, and antiviral activity of GS-9857 alone or     with sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with genotypes 1, 2, 3,     or 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks     after the last dose to monitor for persistence of viral mutations.   "
84056|NCT02185768|"     The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and     epirubicin (12%). But until recently, there were no obvious reasons to use one product over     another. In fact, systemic chemotherapy is considered ineffective in HCC [hepatocellular     carcinoma], which does not allow any argument in favour of the product. Moreover, 2     randomised trials comparing the molecules (doxorubicin vs. epirubicin) proved to be negative     in terms of survival.      Cytotoxicity of different anticancer agents on HCC cell lines have been compared in order to     select the best candidate for CHE. Eleven chemotherapy molecules have been tested, including     those more frequently used in CHE. Among them, idarubicin (an anthracycline) proved to be the     most effective in vitro by far. The superiority of idarubicin (as opposed to doxorubicin) was     noted especially on the SNU-449 line, which is known for its resistance to several     chemotherapy agents. The best cytotoxicity of idarubicin can be explained by 2 mechanisms: 1)     idarubicin has a better intracellular penetration than the other anthracyclines. This is     probably due to its more considerable lipophily, facilitating thus its passage through the     membrane made up of a double lipid layer, 2) idarubicin is resistant to the multidrug     resistance system (MDR). The MDR mechanism, which is often noted in HCC, consists of membrane     pumps transporting the molecule outside the cell. These two particularities could explain a     more significant accumulation of idarubicin in the HCC cells, and thus better efficacy. It is     interesting to note that orally administered idarubicin (5 mg/day for 21 days) has proved to     be less toxic and is effective in HCC. Currently, idarubicin is used to treat leukaemia. Its     toxicity profile (especially, haematological and cardiac) is known.      On these grounds, A pilot study has been conducted in order to assess the tolerance and     efficacy of lipiodol-based CHE using a 10 mg dose of idarubicin in 21 patients with     unresectable HCC. These preliminary data reveal that CHE with idarubicin is effective and     less toxic.      Idarubicin can be loaded in microbeads. A phase I study (IDASPHERE) has been conducted on DC     Beads® microbeads (300-500µm) loaded with idarubicin (dose increased from 5 to 25 mg). The     DLT [dose-limiting toxicity] and MTD [maximum tolerated dose] have been determined in 21     patients using a CRM. The MTD of idarubicin was assessed at 10 mg. In our study, the     idarubicin-loaded beads did not give rise to any specific toxicity-related problem. The 10 mg     dose is compatible with the known toxicity profile of idarubicin: cumulative cardiotoxicity     of doxorubicin is noted from 550 mg/m², whereas that of idarubicin is noted from 93 mg/m².     There is thus a 5.9:1 ratio between their cumulative toxicities. The most frequently used     dose (and also the weakest one) for the doxorubicin-based CHE is 50 mg. The equivalent of the     idarubicin dose would thus be: 50 mg (doxorubicin) / 5.9 (doxorubicin/idarubicin ratio) =     approx. 10 mg of idarubicin.      It has been already demonstrated that hepatic extraction of idarubicin is better than those     of doxorubicin and daunorubicin in an animal sarcoma model. In this study, AUC 0-48h and AUC     0-72h were 1.35 times higher with idarubicin, proving that its intra-hepatic penetration was     35% higher.      The randomised phase II PRECISION V study compared conventional CHE (cCHE) with CHE by     doxorubicin beads (DC Bead®) in patients with HCC. It is currently the largest randomised     trial on CHE published. The PRECISION V data can be thus used to compare the other studies in     terms of efficacy and tolerance.      To continue our preliminary study and the phase I IDASPHERE study, investigators wish to     assess thus the efficacy and confirm the tolerance of idarubicin-loaded beads for the CHE of     HCC according to a protocol similar to PRECISION V, as part of a single-arm phase II study.   "
84057|NCT02185755|"     Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize     health problems and complications. One way for patients to notify doctors and receive     feedback about their blood sugar management is through an online system. As Internet-based     glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators     hypothesize that IBGMS is effective as an intervention even when limiting feedback to     non-medicine related changes.   "
84096|NCT02185248|"     The objective of this study was to determine the effectiveness of a novel Wellness Action     Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing     follow-through with plans and 3) aiding parents in identifying their child's weight category.   "
84298|NCT02182622|"     The purpose of this study is to first determine the highest dose of LDE225 combined wtih     Docetaxel and Prednisone that can be given that does not cause unacceptable side effects when     given to patients with castrate resistant prostate cancer who failed previous docetaxel     therapy.   "
84138|NCT02184702|"     Intubation is needed in general anesthesia and appropriate cuff pressure is important to     avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some     amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure     cuff pressure during shoulder arthroscope.   "
84058|NCT02185742|"     Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and     Suppression) is a project to improve the connection to community care for HIV infected     persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.      Hypothesis: Participants who receive the intervention will be more likely to link to medical     care after jail release than similar participants who do not receive the intervention.      Rationale and objective: This project aims to make sure HIV positive persons leaving jail     maintain medical care. Case managers will use strength based case management and phone     texting technology to improve release's connections to care in the community.      This study will have extensive tracking of outcomes. The key outcome will be whether HIV     infected participants receiving an intervention experience suppression of their viral load     after release from jail . The investigators wish to demonstrate the ability to recruit     participants into the SUCCESS intervention and repeatedly check community medical records to     see how well their infection is being controlled after they linked to care. Investigators     also want to conduct a survey at baseline, 3 months and 12 months.      Investigators will compare the viral load of participants receiving the intervention to     participants passing through the jail who do not receive the outcome.   "
84059|NCT02185729|"     Many patients in the hospital who are malnourished or not eating received intravenous feeding     or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk     of infections and hospital complications. We do not know why TPN increases hospital     complications, but it may be caused by the high sugar or fat content in TPN solutions. The     investigators believe that the high sugar and high fat content can limit the ability to fight     infections and produce stiffness of blood vessels. This study will compare the effect of high     sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel     function. The investigators will also compare the effect of different fats (olive oil and     soybean) in the TPN solution on the risk of infection and blood vessel function on a total of     12 healthy subjects.   "
84060|NCT02185716|"     Postoperative pain is a significant cause of increased morbidity in the perioperative period,     leading to patient discomfort and greater hospital length of stay. Laparoscopic     cholecystectomy associated with significant postoperative pain, a substantial component of     which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has     been used for providing pain relief following abdominal surgeries. We designed this study     with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic     cholecystectomy provides superior analgesic effects than port-side infiltration.      In this randomized and double-blind study, 75 patients who are in American Society of     Anesthesiology (ASA) I-II risk group, between the ages of 20-60, and who will undergo     elective laporoscopic cholecystectomy operation under general anesthesia will be accepted.     The patients will be divided into three groups and they will be given postoperative pain     treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12,     16 and 24,VAS I (superficial pain), VAS II (deep pain), postoperative total analgesic     proportion, nausea, and vomiting will be recorded under evaluation Postoperative sedation     score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1,     2, 4, 8, 12, 16 and 24.   "
84061|NCT02185703|"     The main purpose of the study is to evaluate the impact of treatment with the Chordate System     S020 (medical device) on acute migraine headache pain.   "
84062|NCT02185690|"     MEK162 has shown significant inhibition of tumor growth as a single agent in NSCLC xenograft     models in mice and human cancer cells in vitro, which have KRAS and/or other mutations. These     data suggest that MEK162 may provide a potential benefit in cancer indications harboring     these mutations. MEK162 is currently being investigated in phase I clinical testing and has     been well tolerated up to an MTD of 45mg BID in cancer patients.      There has been little change in survival benefit for patients with non-small cell lung cancer     in recent years. Emerging new treatment options relying on molecular and genetic markers are     being studied extensively. Thus, there has been a shift to manage non-small cell lung cancer     with molecular targeted therapies in combination with standard chemotherapy. This study will     be targeting patients with KRAS mutations.   "
84063|NCT02185677|"     The main objective of the study is to compare the score to the Behavioral Dysexecutive     Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and     cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 3     years) and sex .   "
84064|NCT02185664|"     Cannulation of the internal jugular vein (IJV) for central venous access is a standard     practice in cardiac surgery. In this study, the authors tested the hypothesis that using an     ultrasound (US) scanner would increase the success of IJV cannulation and decrease the     incidence of complications in adult cardiac surgical patients.      The study will include adult cardiac surgical patients, randomized into two groups (control     vs. US). In the control group, IJV cannulation will be performed by the conventional landmark     technique using Seldinger method. In the US group, the course of the IJV will be marked     before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate,     number of attempts, cannulation time and complication rate will be compared for the two     groups.   "
84065|NCT02185651|"     Hypothesis: the effectiveness of treatment of Pompe disease with rhGAA enzyme replacement     therapy (ERT) is limited at least in part because patients develop antibodies against the     provided rhGAA enzyme. Treatment with Zavesca® prior to infusion may dampen or eliminate the     anti-rhGAA immune response in patients receiving ERT, thereby allowing for greater ERT     efficacy.      Treatment with Zavesca® before a enzyme replacement therapy (ERT) may decrease the severity     of, or eliminate infusion associated reactions (IAR) in people with Pompe Disease receiving     ERT.   "
84066|NCT02185638|"     Background:      Supplementation with the combination of Yerba maté, guarana and damiana (YGD) has been found     to slow gastric emptying by 15 to 58%, and to induce a substantial weight loss over 45 days     without changes in diet. Enhanced gastric emptying rate has been shown to reduce the     satiating effect of food and may thereby promote obesity. Yerba maté and guarana are known to     contain large amounts of caffeine, resins, saponins and tannins, whereas damiana contains     ethereal oils, tannins and resins. Caffeine belongs to a class of compounds called     methylxanthines and epidemiological studies suggest that caffeine might possess weight     reducing properties. The sympathomimetic properties of caffeine act to some extent through α-     and β-adrenoreceptors, but most of the sympathoadrenergic stimulation caused by caffeine     (even in very small doses) acts through the dual ability to antagonise adenosine and to     inhibit the activity of cellular cyclic nucleotide phosphodiesterase. Stimulation of the     sympathetic nervous system can cause suppression of hunger, enhance satiety and increase of     energy expenditure covered in part by increased fat oxidation.      Aim:      To evaluate the effect of YGD combination or Akavar 20-50 (A20-50) compared with placebo on:        1. Acute change in 4-h subjective appetite sensations        2. Acute change in ad libitum energy intake (EI) 30 minutes post intake        3. Acute change in serum glucose, insulin, ghrelin and other appetite-regulating hormones          (glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK))      Subjects:      19 , healthy, premenopausal, overweight to obese (BMI between 27 and 32 kg/m2) women(age: 18     to 45 years).      Method:      The study is designed as a 3-way crossover, randomized, placebo controlled, double-blind     study.      The bioactive components will be administered as capsules containing YGD or A20-50. The     placebo capsules will contain rice flower. The subjects will undergo following treatments:        1. YGD capsules        2. A20-50 capsules        3. Placebo capsules      On each test day the subjects will be instructed to rest in a supine position for 15 minutes     before dual measures of blood pressure and HR. A blood sample will be taken (baseline). The     subject's appetite sensations will also be assessed by visual analogue scales (VAS) prior to     intake of the test compound. Immediately hereafter the subjects will be served the first dose     of the test compound. Blood samples will be taken at 15 and 30 minutes (time 0) post test     compound. After 30 minutes post test compound the subjects will be given a standard breakfast     (2.5 MJ = 598 kcal). Additional blood samples will be taken 15 minutes 30, 45, 60, 90, 120,     150, 180 and 240 minutes post-meal, together with a VAS appetite score assessment (0, 30, 45,     60, 90, 120, 150, 180 and 240 minutes).      Immediately after the last blood collection subjects will be asked to take a second dose of     the test compound. After 30 minutes the subjects will repeat one VAS score assessment and be     served an ad libitum lunch.      Blood samples will be analyzed for insulin, glucose, and appetite regulating hormones such as     glucagon-like peptide-1 (GLP-1), ghrelin, cholecystokinin (CCK).   "
84067|NCT02185625|"     The purpose of this study is to determine whether use of the Safe Delivery smartphone     application by midwives can reduce excess blood loss from bleeding, and infant death during     childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery     application can increase midwives' knowledge and skills in managing childbirth.      Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe     Delivery application (intervention), or to no intervention (control). In the intervention     hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be     enrolled at delivery and followed until 7 days postpartum. Data collection will begin July     2014 and is expected to be finished by October 2014.   "
84068|NCT02185612|"     The current literature in social epidemiology and public health suggests that low financial     savings has an unsurprising negative relationship with subjective well-being, and increases     the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis,     and experiencing medical disability. Earn.org is a community-based non-profit based in San     Francisco with a mission to help low-income workers build lifelong savings habits and     financial capability. The organization is one of the largest providers of goal-based savings     accounts or matched savings accounts in the US. The investigators propose to conduct a     randomized controlled trial to determine the health effects of Earn's savings program.     Through this trial, the investigators will test three principal hypotheses: (1) Participants     in the Earn account, as compared to a control group, are hypothesized to demonstrate improved     scores on mental health scales assessing depression and anxiety.      (2) Participants in the Earn account, as compared to a control group, are hypothesized to     experience lower odds of harmful behaviors associated with stress, specifically tobacco and     alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller     effect size, and more delayed, than the effect on mental health outcomes, judging from     similar effects observed in the micro-credit literature.      (3) The mediating variables between Earn account participation and beneficial health outcomes     will include increased optimism and internal locus of control.   "
84069|NCT02185599|"     The study will observe and quantify shifts in colposcopy practice and outcome improvements in     U.S. community-based cervical screening colposcopy examinations after the introduction of the     DySIS colposcope with Advanced Cervical Scan.      The study will collect colposcopy data across multiple sites in two arms; a prospective arm,     with DySIS being used for the examination and a retrospective arm, with data retrieved from     patient charts.   "
84070|NCT02185586|"     We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account     to this new method, the three incisions are all located on the lower abdominal, theoretically     it could get more beautiful outlook and less stress response than traditional laparoscopic     cholecystectomy(two of the three incisions located on upper abdomen) or single port     laparoscopic cholecystectomy(one large incision located on umbilicus).      We plan to conduct a randomized controlled trial to compare those there methods of     laparoscopic cholecystectomy, in order to find out if there will be some advantages of this     new method,such as in lowering the stress response,reducing impact on respiration, relieving     post-operation pain and improving appearance.   "
84071|NCT02185573|"     Three clinical groups will be evaluated. Each group of patients will undergo one method of     Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique -     Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is     going to be made between the three groups in relation to the modified United Sates Public     Health Service (USPHS) criteria of good restorations.   "
84072|NCT02185560|"     This is a non-interventional, multi center post-authorization safety study that includes all     patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with     Sorafenib within a certain period. The investigator should have made the choice of treatment     (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this     study.      The enrollment period is of 9 months. The observation period for each patient starts when the     therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no     longer possible (e.g. lost to follow-up); this will be considered the standard observation     period. Those patients, to whom a total of 24 month follow up is possible, information on     effectiveness including treatment duration and survival status of the patient and of     keratoacanthoma and/or squamous cell cancer development will be collected.   "
84073|NCT02185547|"     This study targets women with moderate depression during pregnancy. We aim to investigate the     direct effect of the newborn child and the long term consequences on the cognitive     developement on children who´s mother has been treated with CBT alone or in combination with     antidepressants.   "
84074|NCT02185534|"     This study will be an open-label, randomised, three-way crossover study in healthy male and     female subjects, performed at a single centre. The objective of the study is to assess the     bioequivalence between one test formulation (Clopidogrel 75 mg tablet (commercial blister     from KRKA) and two reference formulations (Clopidogrel 75 mg tablet [Plavix, sourced in US     and Japan]).   "
84075|NCT02185521|"     Philips has developed a new algorithm, called Hemodynamic Instability Rules Based Advisor     (HIRBA 2.0) system, for the prediction of hemodynamic instability in critically ill patients,     who were not previously known to be at risk. This algorithm provides with the numerical index     - Hemodynamic Instability Index (HII) and its trend which are calculated from existing real     time data derived from patient's current hospital stay such as heart rate and blood pressure,     labs, and Admission - Discharge- Transfer (ADT) data to help healthcare providers obtain     information about patient's status and make clinical decisions.      The aim of the study is to determine if the patient clinical information, displayed in the     form of HII, can prompt possible patient hemodynamic status change and trigger earlier     clinical care team response. Study will also identify if the use of the Philips new algorithm     called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) can improve outcomes for     patients admitted to the intensive care units (ICUs).      During this study, upon patient admission to the ICU clinical data collection will begin.     Data that will be pulled during the study includes: vital signs, medications, reason for     admission to the ICU, results from blood work, treatments that patient may receive.      Research subjects will not be asked to do anything as far as specific activities expected to     be accomplished during study participation. Subjects will be involved in the study only     during their stay in ICU. HII information will be visible to clinicians, taking care of this     patient only during his/ her stay in the study unit. Patients will be randomized into HII arm     (treatment group) and into no-HII - standard treatment arm (control group).      Study team will collect patient information and have the ability to view the HII for subjects     randomized into HII group arm. For subjects randomized into the control arm study team will     collect patient's clinical information but the clinical care team will not have the ability     to view the HII.      Once patient leaves the ICU the study team will collect information on the remainder of     patient's hospital course including date of hospital discharge. All collected data will be     then fully de-identified and released to Philips for analysis.      This clinical investigation is designed to answer several key questions including:        1. Are the performance metrics the same when the algorithm operates in the live host as it          does on retrospective data?        2. Are there opportunities for improvements in the host implementation; including graphical          rendering of the HII information and creation of an alert?        3. Are the predicted workflows which result from the use of the HII clinically acceptable?        4. Is there a difference in the clinical measures for patients who have HII displayed when          compared to those who do not?        5. What is the optimal care process which should be followed based on the presence of the          indicator?   "
84132|NCT02184780|"     This study aims to determine the impact of perinatal exposure to anaesthesia and analgesia on     neurocognitive outcomes in early childhood by analyzing neurocognitive data already obtained     from the local prospective observational cohort study: Growing up in Singapore Towards     Healthy Outcomes (GUSTO).      We hypothesize that:        1. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive          outcomes at 6, 18, 24 and 36 months.        2. Maternal anxiety and depression during the antenatal and post-partum period is          associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.   "
84080|NCT02185456|"     Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of     women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three     months and 70-80% within a year. Given the paucity of information and data regarding     pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown.     Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are     not available.      In 2013, the investigators published two manuscripts documenting a new qPCR based approach to     BV diagnosis and potentially prognosis. The method (LbRC) measures the content of     lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this     study are to validate that this metric is a reliable diagnostic of BV, by determining     sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women     and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is     to determine whether empirically determined low LbRC scores (1-2) in BV patients after     treatment are indicators of recurrence, and whether preemptive action, based on this score,     with more intensive treatment, delays or eliminates recurrence in these patients.   "
84081|NCT02185443|"     This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in     patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal     Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of     extra-hepatic disease or have disease that is planned to be treated with curative intent.      Therefore, SBRT is being considered as a potentially curative procedure.   "
84082|NCT02185430|"     COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During     the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and     hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary     hyperinflation would divert pulmonary blood flow and impair arterial oxygenation.     Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral     vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The     investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min     followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as     bronchodilator in COPD patients when administered during surgery with the one lung     ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a     vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a     vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to     anesthetic agents in COPD patients during the OLV.   "
84083|NCT02185417|"     The purpose of this study is to determine whether chlorthalidone is more effective than     hydrochlorothiazide at preventing cardiovascular outcomes in Veterans over age 65 with     hypertension. Both medications are thiazide-type diuretics that have been used for more than     50 years and are considered first-line treatment for hypertension. Patients currently     prescribed hydrochlorothiazide will be randomized to either continue taking     hydrochlorothiazide or to receive chlorthalidone, and followed for major cardiovascular     events, such as myocardial infarction (MI) and stroke. The study will use a new, efficient     and less expensive study design termed 'point of care', in which study operations will be     conducted centrally and patient data will be collected passively through the electronic     medical record.   "
84084|NCT02185404|"     The objective of this research is to test a passive shoe capable of to test the capability of     a mobile shoe to enhance gait improvements in individuals with asymmetric walking patterns.     Individuals with central nervous system damage, such as stroke, often have irregular walking     patterns and have difficulty walking correctly. Recent research has shown that using a     split-belt treadmill can create after-effects that temporarily correct the inefficient     walking patterns. However, the corrected walking pattern does not efficiently transfer from     the treadmill to walking over ground. The Gait Enhancing Mobile Shoe (GEMS) may allow a     patient to practice walking in many different locations, such as their own home, which we     hypothesize will result in a more permanent transfer of learned gait patterns. To enable     long-term use, our proposed shoe design is passive and uses the wearer's natural forces     exerted while walking to generate the necessary motions.   "
84085|NCT02185391|"     Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine     the risk factors secondary prevention is of great importance. After their residence in     rehabilitation centers patients often get rid of newly required skills. In addition to that     parameters like BMI, blood pressure and cholesterol level return to their initial value.      Using an Audience Response System (ARS) during oral presentations in rehabilitation centers     should improve the learning effect of patients. Furthermore patients will receive motivating     telephone calls in the follow-up. These methods should lead to a sustainable improvement of     learning effects, health care behavior and quality of life.   "
84086|NCT02185378|"     One-lung ventilation, even in patients with healthy weight, causes an impairment in     gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung     ventilation in obese patients would be improved by applying inverse-ratio ventilation,     reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the     restrictive ventilatory effects of obesity, these patients often show a decreased functional     residual capacity and decreased expiratory reserve volume, leading to an overall decreased     tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt     shunting. There are few studies on the one lung ventilation in obese patients about this     prolonged inspiratory time ventilatory method. We plan to investigate the effect of this     ventilation method in obese patients during one lung ventilation.   "
84087|NCT02185365|"     When arthritis starts it can be noticed first in certain molecules in your joint.     Proteoglycan is a molecule that is important to cartilage structure, and is lost as arthritis     develops. Magnetic resonance imaging (MRI) is one of the best ways to image cartilage, and an     investigational MRI technique that has shown great promise in detecting proteoglycan amounts     is called T1-rho.      In this study, patients with hip dysplasia will undergo this investigational MRI in addition     to a well validated MRI method (called dGEMRIC) to see if T1-rho is as good as dGEMRIC at     detecting cartilage damage. The dGEMRIC MRI requires an injection of a contrast agent, while     the T1-rho MRI does not. If the T1-rho is shown to be as useful as the dGEMRIC method it can     then be used to look at cartilage damage in the hip without having to have an injection.   "
84133|NCT02184767|"     This study is to assess the pharmacokinetics of loxapine and will be using plasma     concentration data obtained over 48 hours after administration of the study drug   "
84088|NCT02185352|"     The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction     BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran     radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in metastatic     breast cancer (MBC) patients who have not previously received WBRT.      In past 2 years, the research team has demonstrated that BEEP regimen is a highly effective     treatment for brain metastases of breast cancer progressing from WBRT by a multi-center phase     II study (ClinicalTrials.gov Identifier: NCT01281696). The basic concept of preconditioning,     as referred to starting bevacizumab 1 day before chemotherapy, is that the effect of     bevacizumab induced tumor vascular normalization takes time to mature.      The investigators hypothesized that as induction BEEP decreased the size of brain tumors, the     effectiveness of WBRT would be maximized. The investigators expect this integrated approach     will do greater benefit to MBC patients with BM, irrespective of subtype.   "
84089|NCT02185339|"     The primary objective of the current study is to compare intraoperative respiratory mechanics     in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and     under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative     hemodynamics and postoperative pulmonary function between the two groups.   "
84090|NCT02185326|"     The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI     cycles in poor responders   "
84091|NCT02185313|"     The long-term goal of this research is to advance the investigators knowledge of how the     cerebellum a) controls gaze holding and compensates for impaired gaze stability and b)     modulates vestibular information that is forward-ed from the labyrinth and brought to     perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy     human subjects, patients with chronic (degenerative) cerebellar disorders are inable to     stabilize gaze in eccentric positions, resulting in eye drift towards primary     (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary     position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can     be observed in these patients. Unlike patients with de-generative cerebellar disorders,     patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with     acute deficits of gaze holding and verticality perception.      While a linear relationship between the amount of eye velocity drift and eccentricity of eye     position has been proposed in healthy human subjects, others suggested non-linear behaviour.     The strategy of this research is to characterize gaze holding and verticality perception in     healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic     degenerative cerebellar disorders and to relate eye movement findings with structural imaging     of the cerebellum. The investigators will therefore analyze key cerebellar structures with     regards to loss of volume and relate these imaging findings with the participants' ability to     hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the     flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality     perception in humans.   "
84092|NCT02185300|"     Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada,     Australia and EU. A dispersible tablet has been developed for pediatric use as an alternative     to the granule formulation, already in development, and the approved film-coated tablet. This     is a single-center, randomized, open-label, 5-way crossover study in healthy adult subjects.     The study will evaluate the relative bioavailability of five dosing regimens: 20 mg DTG     pediatric granules (Treatment A) and of DTG 20 mg dispersible tablets (DTG 20 mg DT) after     dispersed in: low mineral content(LMC) water (Treatment B); dispersed in CONTREX™ mineral     water (Treatment C); dispersed in low mineral content water and consumed after standing for     30 minutes (Treatment D) and dispersed in CONTREX mineral water and consumed after standing     for 30 minutes (Treatment E). Safety evaluations and serial PK samples will be collected     during each treatment period. A follow-up visit will occur 7-14 days after the last dose of     study drug. CONTREX is a trademark of Nestlé Waters Corporation.   "
84093|NCT02185287|"     Aim of the study protocol is to evaluate in a prospective investigation of health statistics     if the dysfunctions of the lower urinary tract in women aged between 18 and 40 years may be     the result of past urinary pediatric dysfunction. The aim is to be able to identify the risk     conditions which, if treated properly in early childhood, to help avoid debilitating     problems that manifest themselves as adults and possibly to implement a strategy of     prevention.      The choice of this age group is due to the fact that it allows for easier retrieval of data,     as it is presumed that the concerned can more easily remember their history of pediatric and     / or have parents still young enough to ask for such information. The problems of urinary     disorders in childhood era have been the subject of increased attention by pediatricians from     the end of the 70s, therefore, history taking may be more complete.      A study by Fitzgerald evaluated female subjects with mean age of 56 ± 9 years, and therefore     our study aim is to investigate an age group that does not appear in the literature to     supplement these findings, already reported.      Ultimate goal is the need to raise awareness of Pediatric Urologists to interact with adult     Urologists in order to implement a shared strategy for the management of patients with     problems of impaired bladder function in order to improve the future lower urinary tract     function.      Materials and Methods: A self administered questionnaire will be used in accordance with the     guidelines of the International Children's Continence Society. The questionnaire consists of     two parts: the first explores the history of urological clinic patient until the age of 14,in     order to evaluate any symptoms reported in a specific category of typical dysfunction of     childhood; the second part refers to the present together with urological disorders of sexual     function which, as emerges from the data of the literature may be of relevance urological     diseases detectors. The data obtained will then be subjected to statistical calculations by     which will evaluate the significance of the symptoms present in childhood in relation to     their penetrance in various forms of adult diseases dysfunctional bladder and / or sexual     abuse, with the prediction of the evolution of the same.      The questionnaire is anonymous in order to protect privacy. The questions that comprise it     have been partly extracted from the questionnaire validated by the International Children's     Society Continent and partly made by the authors of this study on the basis of the scientific     evidence.      Patients will be recruited from the outpatient clinic of the Urogynecology Urology Clinic,     University of Perugia, while the healthy controls will be recruited by submitting a     questionnaire to the women chosen to sample a healthy population of Graduate Schools found in     the framework of Urology, Pediatrics and Pediatric Surgery, University of Perugia.      The Investigators defined that the statistically significant number of healthy and     pathological subjects can not be less than 200 units per reference category.      The time duration of the collection of anamnestic data depend on the ability of the authors     of this research in finding the subjects to be analyzed.      There are no conflicts of interest to declare, no drugs or medical equipment will be tested .   "
84094|NCT02185274|"     Gender identity disorders (also known as transsexualism) is defined as a condition in which a     person with apparently normal somatic sexual differentiation is convinced that he or she is     actually a member of the other sex. Most patients therefore undergo so called cross-sex     hormone treatment. Treatment protocols follow international consensus statements but vary     considerably between different centres and countries since no prospective and controlled     trials are available on this subject and recommendations are mainly based on retrospective     data analysis and experience of the individual centres. Applying high doses of testosterone     to biological females and vice versa high doses of estradiol to biological males definitely     impacts myriads of body functions, from which it has to be assumed that only a minority has     already been elucidated so far. Especially in male-to-female-transsexuals there seems to be     an increased risk for the development of mood disorders and cardiometabolic comorbidities. In     this multi-center observational study we want to investigate, if there is any difference with     regard to these outcomes, according to the varying standards of cross-sex hormone treatment     between the different centers. Different outcome measures described below will be assessed     each time during routine visits at the different centers.   "
84095|NCT02185261|"     This study aimed to evaluate the efficacy of interferon α among patients undergone     unmanipulated blood and marrow transplantation following day 60 post-transplantation who were     minimal residual disease positive after transplantation.      Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute     leukemia and many other hematological malignancies. However, post-transplant relapse can     occur in some patients, and the prognosis of these patients is usually very poor.The     persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is     an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen     patients with a high risk of relapse to provide timely intervention and prevent     post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect.     It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell     functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients     with MRD-positive after transplantation.      The study hypothesis:      Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation     in patients with standard risk acute leukemia can reduce relapse rate.   "
84097|NCT02185235|"     Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse     (POP), and fecal incontinence—which often occur together.      Pelvic floor disorders impair multiple aspects of the life quality, including the sexual     function of women.      Surgery became the first choice of treatment, however, and not until 1980s was the renewed     interest in conservative therapies.      This may be because of higher awareness among women and cost of and morbidity after surgery.      The conservative treatment included pelvic floor muscle training, electrical stimulation,     vaginal cones, and biofeedback.      The outcome was up to 35~70 % improved rate as the literature before. Current guidelines     recommended conservative management as a first-line therapy. However, there was no consistent     consensus on this issue due to variations in stimulation parameters、adjuvant concurrent     modality or duration of treatment course, and insufficient result about large and long term     follow up of randomized- controlled studies.      Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the     efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary     incontinence, chronic pelvic pain etc.).      At the aspect of Quality of life, our studies tried to focus on the different domains of     pelvic disorder and sexual quality by means of validated questionnaire more objectively.   "
84098|NCT02185222|"     As recommended allowance of oral vitamine D are unable to ensure the recommended serum     concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3     higher than the recommended allowance may slow the cognitive decline of patients with a     memory complaint.   "
84099|NCT02185209|"     The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in     the treatment of periimplantitis is needed.   "
84100|NCT02185196|"     Background:        -  Burden: Pneumonia is the leading cause of morbidity and mortality in under-five          children, particularly in developing countries.        -  Knowledge gap: Although many studies have reported an association between vitamin D          deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e.          the impact of vitamin D supplementation in the management of childhood pneumonia.        -  Relevance: Vitamin D plays an important role in modulating the innate immune response          against infections. We, therefore, propose to conduct this study to assess the impact of          vitamin D supplementation, in addition to standard antibiotic and supportive therapy, on          the outcome of severe childhood pneumonia.      Hypothesis: The investigators hypothesise that in the management of hospitalized severe     pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard     antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may     thereby shorten duration of severe pneumonia and also reduce the risk of new episode of     pneumonia.      Objectives: The objective of the investigators study is to assess the clinical benefit of     oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive     therapy, to hospitalised, under-five children with severe pneumonia.      Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children     of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically     diagnosed severe pneumonia will comprise the study population. Eligible children will be     allotted a sequential study number, which will have been previously assigned to vitamin D or     placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the     children will be blinded as to whether vitamin D3 or placebo has been added to their child's     diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6     months or older will receive Milk Suji as a complementary food. Vitamin D3 supplementation     will be given on five consecutive days, from the day of enrolment in addition to standard     antibiotic and other supportive therapy.      Outcome measures/variables:      Primary outcome measure will be time to resolution of severe pneumonia.      Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in     drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new     episode of pneumonia after discharge.   "
84101|NCT02185183|"     Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will     be tested in patients with inflammatory bowel disease.   "
84102|NCT02185170|"     The aim of this study is divided in 4 different steps:        -  the first step has two different purpose: assess the impact of the storage medium of          fresh prostatic chips on fluorescence signal and adjust the entire chain          (immunolabelling,counter-stain and imaging),        -  the second step is the adaptation of immunolabelling protocol on histopathology slides,          using fresh prostatic tissue,        -  the third step is to validate the use of:             1. the medical device created by the FEMTO-ST institute use for the detection of               fluorescence signal on fresh tissue,             2. the Light-CT scanner use for tissue structural observation.        -  the four step is to check the preservation of morphological structure of tissue under          the effect of laser excitation from the medical device.   "
84103|NCT02185157|"     The training of a secondary task while walking, whether it is reasoning activities, memory or     motor tasks, may enhance automation, walking performance, and postural control and, thus,     minimize the risk of falls influenced by the walking patterns variability. However, the     literature is scarce regarding the influence of dual-task training on changes in gait     parameters.      The purpose of this prospective, blinded randomized controlled trial is to compare the short-     and long-term effects of dual-task and aerobic training on gait stride variability and     superior cerebral functions of independent community-dwelling elderly women.      The participants will be randomly allocated into either experimental or control groups.The     experimental group will undertake 50 minutes/day of dual-task training, three times/week over     12 weeks, totaling 36 sessions, whereas the control group will receive the same doses of     aerobic training. At baseline, after 18 and 36 sessions, and 12 weeks after the cessation of     the interventions, researchers blinded to group allocations will collect the outcome     measures.The interventions will be delivered by trained physical therapists.      Primary outcome will include gait stride variability, which will be assessed by a movement     analysis system: the GaitRite® system, during cognitive and motor dual-tasks, at both normal     and fast speeds. Secondary outcome measures will include a battery of global and specific     cognitive function tests.      The findings of this trial may help better understand whether cognitive-motor interventions     with older adults, when compared to traditional aerobic training, would result in greater     improvements in gait under dual-task conditions and lead to improvements in cognitive tasks.     Furthermore, the findings could potentially bring important insights regarding the impacts of     improvements in walking abilities and cognition.   "
84104|NCT02185144|"     The PATH for Triples (PFT) Study is an effectiveness trial comparing a nurse health navigator     (NHN) model for HIV+ persons with severe mental illness and substance abuse (i.e., triply     diagnosed) with Treatment as Usual (TAU). The team completed a Phase II trial of the nurse     health navigator model for HIV+ persons with severe mental illness that showed the     intervention was effective. The investigators are now testing the intervention in a real     world setting with patients recruited from psychiatric and substance abuse inpatient units in     Philadelphia using a longitudinal design. The intervention is set up as a cascade where     non-adherent patients receive additional visits from the study nurses. It is hypothesized     that patients assigned to the NHN will have better medication compliance, reduced viral loads     and improved CD4 counts compared to patients assigned to TAU. It is also hypothesized that     the PFT intervention group will be more cost effective compared to TAU. This group of triply     diagnosed patients are at very high risk of negative health outcomes and secondary     transmission of HIV and, therefore, the study is of high public health significance.   "
84134|NCT02184754|"     Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope     navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in     which scope navigation is particularly important. The MEI will be compared with x-ray which     is still the current gold standard for scope navigation in small bowel enteroscopy.   "
84105|NCT02185131|"     Mirtazapine is a non-SSRI (selective serotonin reuptake inhibitor) medication with a unique     structure and mechanism of action. Recent study results suggest that mirtazapine may be more     effective and faster acting than other antidepressants. Levels of alcohol use have been shown     to be associated with levels of depressive symptoms among comorbid populations. Our own     recent open label pilot study suggested robust within-group efficacy for mirtazapine for     decreasing both the drinking and the depressive symptoms of persons with co-occurring alcohol     dependence/major depressive disorder (AD/MDD). However, no placebo control group was employed     in that study, so between-group efficacy versus placebo could not be assessed. The current     grant submission proposes to conduct a first double-blind, placebo-controlled study to     evaluate the efficacy of mirtazapine versus placebo for decreasing the alcohol use and     depressive symptoms of persons with comorbid AD/MDD. If the results of this proposed     double-blind pilot trial are promising, then the effect sizes found in this proposed study     will be used to help design an adequately-powered R01 treatment trial to definitively test     the efficacy of mirtazapine in this comorbid population.   "
84106|NCT02185118|"     Sepsis is a major cause of death in intensive care units. Despite the investigators improved     understanding, which has reduced the risk of dying with sepsis, the number of people who die     each year continues to increase due to an overall increase in the number of cases.In our     previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar     concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line     against in-vitro sepsis induced by lipopolysaccharide (LPS).      In this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC     isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis     induced by LPS or plasma from septic patients.   "
84107|NCT02185105|"     The study hypothesis is there is no difference in the clinical performance between the test     and control lenses, in particular in lens stability, toric mislocation, comfort ratings and     anterior segment ocular health findings.   "
84108|NCT02185092|"     The purpose of the study is to examine the hypothesis test that probiotics will reduce the     frequency of exacerbation in patients with COPD.   "
84109|NCT02185079|"     Procedural skills are an important determinant of clinical outcomes for certain patient     groups. Training for procedural skills in the medical profession is still largely based on an     apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by     practicing on patients under direct supervision by seniors (consultants or senior     registrars/residents). Learning a complex and high risk procedural skill on patients is not     ideal.      As medical training moves from apprentice based to competency based training along and as for     the number of clinical learning opportunities for trainees is less, it is necessary to     develop a comprehensive training programme which enables effective and efficient learning     without compromising on patient safety. Metrics-based performance based progression has shown     to improve clinical performance not only in novices but also in experts.      We envisage a standard methodology which could address the deficiencies in procedural     training currently. This would entail development and validation of a set of metrics for a     particular procedure, evaluation of a proficiency based progression training programme based     on those metrics to and demonstration of improved clinical performance and clinical outcome     associated with that programme. Although elements of this end -end approach have been     demonstrated previously for various procedures, we propose to apply this methodology in its     entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To     date we have developed and are validating a set of metrics for this procedure. Proficiency     based training leading to better procedural skills leading to better patient outcomes has not     been studied so far. Epidural analgesia during labor lends itself as an excellent model for     evaluating the whole process. It has a specific procedural skill which is closely linked to     patient outcome which is measurable and occurs in finite time interval.      The hypothesis of the study is that in novice anaesthetic trainees, training with metrics     based performance based progression in addition to improving the clinical performance will     also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved     by conventional training.   "
84110|NCT02185066|"     This study is designed to evaluate safety and pharmacokinetic properties of the two     treatments, the administration of CJ-30056 and the co-administration of atorvastatin and     metformin XR, in healthy volunteers.   "
84111|NCT02185053|"     This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple     Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with     Alzheimer's Disease Type Dementia.   "
84112|NCT02185040|"     The purpose of this study is to determine whether CC-220 is effective for the treatment of     skin, joint and serological manifestations of systemic lupus erythematosus.   "
84113|NCT02185027|"     The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran     (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel     questions among clinicians confronted with the emergency management of patients treated with     these new drugs. It is likely that these new oral anticoagulants (NOACs) will eventually win     a significant market share in the indications secondary prevention of venous thromboembolism     and prevention of cardioembolic events in patients with nonvalvular atrial fibrillation, due     to their net clinical benefit and their practicality of use compared with vitamin K     antagonists (VKAs).      However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about     half compared with VKAs, the risk remains significant; furthermore, in clinical trials, these     drugs had little or no effect on reducing the incidence of major extracranial bleeding. In     everyday practice, where the indication could be expanded to unselected populations and due     to a potential for misuse, it is likely that the incidence of bleeding complications will be     higher than that reported in clinical trials. Indeed, the numerous alerts emanating from     regulatory agencies in various countries (US, Australia, etc.) bear witness to this, and     should serve as a reminder that these anticoagulants have a real potential for bleeding     complications and, in the absence of an antidote, there is no validated management strategy.      Furthermore, as these drugs can be prescribed for months or years, patients may eventually be     exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive     procedures, trauma, etc. Analysis of data from the RE-LY trial (dabigatran versus warfarin in     patients with atrial fibrillation) showed that during the two years of follow-up,     approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker     insertion to major surgery. Thus, a large proportion of patients treated with NOACs are     concerned by this issue.      In anticipation of a gradually increasing influx of patients in a critical situation (active     bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to     define the conduct to adopt based on the experience gained from the earliest cases. This is     the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French Working     Group on Perioperative Hemostasis).      For the moment, then, the management recommendations derive from expert opinions based on     pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by     various nonspecific procoagulants (non-activated or activated prothrombin complex     concentrates, recombinant factor VIIa). These procoagulants are currently used in an     empirical manner to control bleeding, with as many successes as failures reported in the     literature, and their benefit-risk ratio in these patients is therefore uncertain.   "
84114|NCT02185014|"     This study will evaluate the long term efficacy, safety, and tolerability of repeated     administration of adalimumab in subjects with Crohn's disease.   "
84115|NCT02185001|"     Background: The forces involved in a patella dislocation event can cause significant     collateral damage involving the articular cartilage of the patella femoral joint. As a     result, prevention of recurrent patella dislocation and the associated disability and     morbidity has generated significant interest in the orthopedic community. Historically,     nonoperative treatment for first time patella dislocation has been problematic due to high     redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization,     followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both     soft tissue and boney realignment operations, have also had mixed results, including low     success rates, associated complications, and variable rates of return to functional activity     (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial     Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment.      Methods/Design: This study is designed as a two arm randomized prospective trial.     Approximately fifty subjects will be randomly assigned to either a surgical or non-operative     arm by means of a computer randomized allocation program. All subjects will have X-Ray Images     and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to     determine if any excluding conditions exist. Subjects randomized to the surgical group will     have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that     has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive     2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical     therapy for approximately 12 weeks. Physical therapy will progress through five phases with     the goal of gait normalization, full range of motion and return to sport. Both arms will be     given outcome questionnaires and physical activity assessments before treatment, and at one,     three, six, twelve, and twenty four month intervals.      Discussion: This prospective randomized trial will investigate the results of direct repair     of the medial patellofemoral ligament and conservative treatment by applying subjective     outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration     or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and     six months post trauma. Any reported recurrent dislocation or subluxation event will be     documented during recovery. All subjects will receive merchant x-ray views at 3 months with     manual lateral translation of the patella.   "
84116|NCT02184988|"     The purpose of this study is to demonstrate the safety of multiple doses of DWP-450     (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe     glabellar lines in adult subjects.   "
84135|NCT02184741|"     To estimate the safety and efficacy of intravenous immunoglobulin therapy using GB-0998 in     women with four or more miscarriages by carrying out randomized, placebo-controlled,     double-blinded study．   "
84136|NCT02184728|"     An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for     PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread     use of capnometry on-site at emergency and trauma fields. So, portable device can be used     usefully.   "
84119|NCT02184949|"     The relationship between annual procedural volume and patient outcome remains a debated issue     in the field of interventional medicine. An under-explored issue in a UK context is whether     or not such a relationship exists for percutaneous coronary interventions (PCI). In recent     years, this procedure has replaced thrombolysis as the standard intervention method used in     UK hospitals for widening patients' obstructed coronary arteries. However, the actual number     of such procedures currently undertaken annually remains variable across hospitals where     these interventions are performed. The UK's National Institute for Health and Care Excellence     has consequently called for research into whether such differences in volume play any role in     patient outcome for this particular procedure. The current study is intended to address that     research need, and will do so by looking at whether the annual number of PCI procedures     undertaken by individual hospitals is predictive of patient mortality post-procedure.   "
84120|NCT02184936|"     Treatment of acute ischemic stroke is aimed at salvaging viable but ischemic brain by opening     the occluded artery and restoring anterograde perfusion as quickly as possible. Time saved     while making critical decisions correctly is vital in acute ischemic stroke management.     Conventional angiography is invasive, resource intensive and not feasible as a fast     diagnostic tool. Perfusion CT and MRI are both susceptible to patient motion, need trained     personnel to process and take at least 10-30 min to acquire and interpret. The investigators     have developed a new imaging selection tool, multi-phase CT Angiography (CTA), which     generates multiple time resolved images of backfilling arteries beyond a blocked artery     filled by collaterals.      The investigators seek to determine: i) if patients with acute ischemic stroke will have a     differential clinical response to early recanalization based on collateral status assessed on     multi-phase CTA, ii) if the extent to which collateral assessment on multi-phase CTA     resembles perfusion CT in predicting which patients will have good clinical outcome with     early recanalization, iii) Identify determinants of variability in native collateral status     in patients with acute ischemic stroke.      The investigators hypothesize that patients with good and intermediate collaterals on     multi-phase CTA achieve good clinical outcome with early recanalization (within 4 hours of     baseline imaging); patients with poor collaterals do not do well even with early     recanalization.      Prove-IT is a prospective multi-center hospital-based cohort study of 500 consecutive     patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with     evidence of intracranial occlusion on routine CTA over 3 years. Calgary and seven other     comprehensive stroke centers will recruit patients into this study. Primary outcome is     defined as a National Institute of Health Stroke Scale (NIHSS) score of 0 to 2 at 24 hours or     an 8-point drop in NIHSS score from baseline to 24 hours. Secondary outcomes are a) 90-day     modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS; b) percent neurologic     improvement comparing NIHSS at baseline to 24 hours; c) 90-day NIHSS score 0-2; d) infarct     volume on 24 hour imaging and e) parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II     criteria) at 24 hrs.      Prove-IT looks to establish the ideal imaging selection tool for intra-arterial (IA) and     thrombolysis decisions in the setting of acute ischemic stroke which is widely available, and     can quickly and reliably detect salvageable brain.   "
84121|NCT02184923|"     The long-term goal of this research is to advance our knowledge of how information from the     labyrinth is brought to perception and how adaptation to vestibular imbalance influences     spatial orientation. In healthy human subjects verticality perception is accurate while     upright.The strategy of this research is to quantify changes in verticality perception after     unilateral lesions along the central graviceptive pathways and to assess the frequency and     pattern of abnormal verticality perception in patients with acute stroke (ischemic or     hemorrhagic). Our underlying hypothesis is that screening for erroneous verticality     perception by use of a mobile device assessing the subjective visual vertical (SVV) during     the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those     patients with defects. Early detection of deficits in verticality perception may help to     initiate balance physiotherapy early.   "
84122|NCT02184910|"     It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which     leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to     assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for     atrophic gastritis and whether gastric atrophy based on the PG test would be improved after     H. pylori eradication.   "
84123|NCT02184897|"     Twenty four patients with multiple myeloma will be randomized to either AM group     (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ).     Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4     in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with     pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic     progenitor cell count. In addition, the yield of stem cell collection between two arms will     be analyzed.   "
84124|NCT02184884|"     The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength,     maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in     platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A     study reported that the TEG® can be used as routine monitoring of the variability in ADP     receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay,     we could find out the perioperative clopidogrel responsiveness of the patients with ACS     undergoing OPCAB.      The purpose of this study is to determine whether the rate of the major adverse cardiac     events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in     the patients with high degree of clopidogrel resistance, who are scheduled to undergo the     OPCAB due to ACS.   "
84125|NCT02184871|"     The aim of the present study is to perform a comprehensive molecular characterization of     intrahepatic cholangiocarcinoma (ICC) in patients exposed to well-known or putative risk     factors (such as asbestos) for this malignancy, in order to identify possible molecular     signatures associated to such different risk factors.   "
84126|NCT02184858|"     This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and     safety of lisinopril in children 1-18y whose parents grant permission to participate. This     dose titration study is being conducted to support the statement that personalized titration     of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient     response.   "
84127|NCT02184845|"     Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single     crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area.   "
84128|NCT02184832|"     This study will examine the influence of dietary intake of tryptophan on response to     metformin. The investigators hypothesize that dietary tryptophan alteration will influence     metformin response.   "
84129|NCT02184819|"     The investigators want to test the hypothesis that an infusion of levosimendan started prior     to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients     with poor LV function (EF 40% or less).   "
84130|NCT02184806|"     Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way     to restore fertility is autotransplantation of ovarian tissue.      The principal purpose of this study will be to evaluate the efficiency and safety of this     procedure.   "
84143|NCT02184637|"     This will be a single-centre, 5-cohort, randomized open-label, parallel-group study in     healthy volunteer subjects. This study aims to provide sufficient pharmacokinetic (PK)     evidence to support the safe usage of Tafenoquine (TQ) in studies and markets where the     Artemisinin-based Combination Therapies (ACTs) are the standard of care for patients with     Plasmodium vivax malaria (i.e., co administration with TQ). The objective of this study is to     assess the pharmacokinetics, safety and tolerability of TQ when co-administered with the     chosen ACTs (AL and DHA + PQP), administered concomitantly in healthy subjects. Specifically,     the study will evaluate whether there are drug-drug interactions between TQ and each of the     ACTs and if these interactions are considered to be clinically significant. The co-primary     objectives of this study are to characterize both the effects of a 300 milligram (mg) single     dose of TQ on the pharmacokinetics; changes in (area under the concentration-time curve from     0 to time t) AUC (0-t), AUC (0-infinity), and maximum observed concentration (Cmax) of each     of the two Artemisinin-based Combination Therapies (ACT) according to their prescribed dose     when co-administered as well as the effects of the ACTs on the PK of TQ.      A total of 120 subjects (24 subjects in each of 5 cohorts) are planned to be enrolled in     order to ensure a target sample size of at least 22 subjects completing the study per cohort.     All subjects will arrive in the unit at least 24 hours prior to dosing and be discharged     after 72-hour post first dose assessments have been completed. Subjects will return for     outpatient visits on Days 7, 14, 21, 28, and 56 after first dose.   "
84144|NCT02184624|"     This is a randomised, open-label, placebo, crossover, multicentre study with a single visit.     The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo)     via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they     are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other     inhaler devices that will be used in this study will be included. Furthermore, subjects who     are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler     devices that requires a capsule. The study will be conducted in the UK and the Netherlands,     and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will     be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be     allocated to one of the sub-studies depending on their experience of using the other inhaler     (i.e., depending on which other inhaler they are naïve to).      This study is designed to assess the proportion of COPD subjects making critical and overall     (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other     commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI     and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference     between the ELLIPTA inhaler and the other commercially available inhaler devices.      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.     TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of     Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis     AG.   "
84155|NCT02184481|"     Depression is associated with impairments in executive functions, including working memory     (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM     impairments depressed individuals have difficulties inhibiting and shifting from irrelevant     (negative) information and updating goal relevant information. This study explored whether     training WM decreases these impairments and reduces clinical symptoms of depression, anxiety     and rumination. Sixty-one students with an elevated score on the BDI-II, representing a     dysphoric mood state, executed a working memory training (n = 34) or placebo training (n =     27). Before and after training their depression, anxiety, rumination and working memory were     assessed. Furthermore, they executed a working memory task while their pupil dilation was     measured to assess their fatigue. Moreover, the investigators compared the dysphoric students     with a healthy student population on all measures.   "
84156|NCT02184468|"     The purpose of this study is to determine if dual dispatch of ambulance, fire fighters and/or     police in out-of-hospital cardiac arrest (OHCA), can reduce the time to cardiopulmonary     resuscitation (CPR) and defibrillation, thus increasing survival.   "
84146|NCT02184598|"     Purpose: This project assess the effectiveness of a cognitive training as an add-on     intervention to drug treatment in children and adolescents diagnosed with     Attention-Deficit/Hyperactivity Disorder (ADHD) compared to a placebo training. The cognitive     training consists of 6 computerized games that are based on principles of neuroplastic     change.      ADHD: current treatment - International clinical guidelines indicate that pharmacological     interventions in particular stimulants are the first-line treatment for ADHD. However, about     30% of children affected by the disorder do not respond to medication alone, exhibit partial     response or can not tolerate the adverse effects. In addition there is a group of parents who     do not accept the use of medication for the treatment of ADHD in their children. In recent     years cognitive training has received considerable attention as a treatment to ADHD. The     evidence base for cognitive training programs are still forming with few randomized     placebo-controlled studies. However, this approach seems to be effective either as a     treatment for ADHD - and others cognitive disorders in childhood - or as a tool to enhance     cognitive ability and school performance in children and adults. No previous study has     evaluated this cognitive intervention in a clinical trial with placebo-controlled     intervention and as an adjunctive treatment to medication. Additionally, the investigators     will assess brain changes associated with this intervention using neuroimaging (fMRI).   "
84176|NCT02184208|"     Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic     monitoring are under-utilized when translating research into decision support. Current     medical informatic capabilities can be leveraged to calculate trends in measured parameters     to initiate a paradigm shift in critical care from reaction-based treatment to proactive and     plausibly preventative care. Therefore, the purpose of this study is to develop baseline     understanding of our practice and how data collection utilizing a newly implemented system     called T3. We would like to retrospectively review mechanically ventilated patients in which     we have collected continuous data to test a newly developed analytic platform. Additionally     we would like to compare these results to our standards of practice established by clinical     practice guidelines.   "
84177|NCT02184195|"     A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance     Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose     Disease Has Not Progressed on First Line Platinum Based Chemotherapy   "
84147|NCT02184585|"     This study will be an open-label, randomized, single dose, three way crossover study in     healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of     two formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin     hydrochloride (HCl) (0.5 milligram [mg]/0.2 mg) relative to co-administration of dutasteride     0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets in both the fed and fasted     states. Approximately 84 healthy adult male subjects will be enrolled into the study and     split into two cohorts (fed and fasted), allowing for approximately 36 subjects to complete     each cohort. Subjects from both cohorts will receive single oral doses in 3 treatment periods     and be randomized to one of six different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)     wherein A= FDC1: Dutasteride and tamsulosin HCl (0.5 mg/0.2 mg), B= FDC2: Dutasteride and     tamsulosin HCl (0.5 mg/0.2 mg), C= Co-administration of commercial formulations of     dutasteride(0.5mg) and tamsulosin HCl (0.2mg). Each treatment period will be separated by a     minimum 28 day washout period. Blood samples for pharmacokinetic analysis will be taken at     regular intervals after dosing. Safety will be assessed by measurement of blood pressure,     heart rate and review of adverse events.   "
84148|NCT02184572|"     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     trivalent MMR (Priorix®), comparing it to Merck's MMR vaccine (M-M-R®II), which is approved     for use in the US in healthy children 12 to 15 months of age.   "
84149|NCT02184559|"     The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia     and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention,     respiratory depression ...). In the case of caesarean sections, the quality of analgesia     allows one hand to improve the mother-child relationship and the quality of breastfeeding,     the other to reduce the risk of postpartum depression and chronic pain . Two methods of     administration of local anesthetics have been proven effective for analgesia of the abdominal     wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of     the scar continues operating. The TAP block was performed under ultrasound guidance by the     anesthesiologist after the intervention in a single injection of local anesthetic in the     abdominal wall and has a period of limited and variable. The infiltration continues catheter     is placed by the surgeon before closing the wound and allows the infusion of local     anesthetics for 48 hours.      The purpose of this study was to compare morphine consumption between both techniques, and     the quality of analgesia and side effects of morphine   "
84151|NCT02184533|"     The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium selenite     when administered in combination with radiation therapy to subjects with metastatic cancer     based on safety and tolerability.   "
84152|NCT02184520|"     This postmarket surveillance study is being conducted to evaluate the TRANSITION     Stabilization System as an adjunct to fusion in the treatment of acute or chronic     instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve     up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization     System. The data from this postmarket surveillance study will be provided to FDA in     accordance with the 522 order.   "
84153|NCT02184507|"     The present study aimed to evaluate the effect of a combination of insulin resistance     reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood     glucose and oxidative stress regulation.   "
84154|NCT02184494|"     Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's     Disease (PD) and Multiple Sclerosis (MS). There are multiple proposed mechanisms of     disorder-related fatigue, however, it is unknown whether PD or MS patients experience     compromised blood lactate responses to an acute bout of exercise, subjecting them to     exercise-related fatigue. These populations may experience higher energy expenditure at rest     due to increased rigidity, however, limited data exists investigating resting energy     expenditure in these populations.      Researchers hypothesize that PD and MS patients will display higher resting energy     expenditure than healthy age-matched controls, and that level of energy expenditure will     correlate with amount of rigidity or spasticity. Also, we hypothesize that baseline levels of     lactate will not be different between PD/MS and control groups, but post-exercise blood     lactate levels will be significantly higher in the PD/MS groups.   "
84157|NCT02184455|"     The purpose of this clinical trial is to perform a limited pilot study to determine the     safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU).     This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will     result in positive healing outcomes with no significant adverse effects.   "
84158|NCT02184442|"     The purpose of this post approval study is to determine the safety, effectiveness and     learning curve of the SAPIEN™ THV with the Retroflex delivery system for Inoperable Patients     and with the SAPIEN™ THV with Retroflex and Ascendra delivery systems for high risk operable     patients with Severe Symptomatic Native Aortic Stenosis via all access sites.   "
84159|NCT02184429|"     This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in     healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of     food on PF-06669571 plasma concentrations will be be evaluated after a single dose of     PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days   "
84160|NCT02184416|"     This is an international, multi-centre, prospective (partly retrospective), observational     study to evaluate treatment patterns and clinical outcomes in patients with advanced or     metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line     post sunitinib. The study is designed to enroll approximately 750 patients over the course of     an enrollment period of approximately 36 months.   "
84185|NCT02184091|"     Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency     on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to     establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired     patients   "
84186|NCT02184078|"     Study to determine the effects of nevirapine on the steady state pharmacokinetics of     rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in     combination with rifabutin   "
84187|NCT02184065|"     Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican     population with rheumatic diseases   "
84161|NCT02184403|"     Laryngeal cancer is common in the Taiwanese populations. Before early 80's, open laryngectomy     was the suggested treatment modality for laryngeal cancer. Patients of laryngectomy lost     speech and should communicate by using prosthesis. So after 90's, medical organ preservation     by chemoradiation therapy took the place of operation.      Unfortunately, from the recent review, five-year survival rate was decreasing and is even     lower than that reported 10 years ago. In 1983-1985 it was 68.1% but decreased to 64.7% in     1992-1999. It is the only cancer type of decreasing survival in 24 index cancers.      Laser resection of laryngeal tumor was first reported by Jako and Strong and widely used in     the Europe. Dr Steiner and his colleagues developed a non-en block resection technique made     microscopic resection more easily and would not be limited by tumor location or size so much.     The investigators used transoral microscopic laser (TLM) in early glottic cancer and reported     five-year overall survival as 97%. TLM five-year disease control rate was reported as 85%.     There are some reports about TLM in advanced stage laryngeal cancer and overall 5-year     survival rate can be achieved as high as 55%. Present project is planning to develop a     comprehensive organ preservation protocol based on microinvasive TLM as primary treatment     modality for early glottic cancer without neck or distant metastasis. The objects of the     project are as followed.        1. Long term outcomes by performing the treatment protocol. The outcome measurements          include local control rate, overall and disease specific survival, larynx preservation          rate.        2. The difference between surgical samples and pretreatment imaging examination.        3. The role of adjuvant therapy.        4. Management and follow-up in neck metastasis.        5. Searching for risk factors and predictor factors.        6. Adequate salvage treatments in local or regional recurrence.        7. Realizing failure patterns and appropriate follow-up protocol according to it.   "
84162|NCT02184390|"     This study will evaluate the efficacy and user satisfaction with a web-based interactive     tutorial for caregivers of young children with autism designed to a) teach parents how to     promote their child's development in the core deficit areas, b) help parents understand and     improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress     through more effective interactions. It emphasizes everyday situations as opportunities for     learning, including common home routines and contains videotaped illustrations of parents     using the techniques taught in the home environment.   "
84163|NCT02184377|"     Mandarin Chinese phonemically distinguishes four tones, with Tone 1 having high-level pitch,     Tone 2 high-rising pitch, Tone 3 low-dipping pitch, and Tone 4 high-falling pitch The same     segmental context carries different meanings depending on the tone. The function deficit of     cricothyroid (CT) muscle, innervated by external branch superior laryngeal nerve (eSLN),     would impair the speech tone adjustment. The defect in tone adjustment may interfere with the     communication function in Mandarin Chinese speaker more than other language users. This may     explain while peripheral unilateral vocal fold paralysis (UVFP) patients with eSLN injury had     worse outcomes than those with sole recurrent laryngeal nerve paralysis. The neuromuscular     control of laryngeal muscle can be evaluated by laryngeal electromyography (LEMG). The     investigators have utilized a quantified LEMG (denoted Q-LEMG) in their previous research to     measure the neuromuscular control of thyroarytenoid- lateral cricoarytenoid (TA-LCA) adductor     complex. However, the task to measure the CT muscle function by Q-LEMG has not been developed     yet. It is of thus of utmost interest to develop a standardized task to measure the     neuromuscular function of CT muscle in Mandarin speakers. In Mandarin speaking patients with     UVFP, the lexical tone influence from CT muscle can be discovered by the technique. The     investigators also want to measure the lexical tone correction by conventional laryngoplasty     and its influence in CT muscle activity. The data of lexical tone and its correlation with CT     contractile activity is important in attempting pitch adjust artificial electrolarynx.   "
84164|NCT02184364|"     To investigate, relative to placebo and conjugated oestrogens, the efficacy, safety and     tolerability of a 12 weeks peroral treatment twice daily with a cimicifuga racemosa extract     corresponding to 20 mg, 75 mg or 150 mg plant material on menopause-related neurovegetative     and mental complaints   "
84165|NCT02184351|"     The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole     troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where     this condition has been diagnosed by clinical examination and confirmed by fungal culture.   "
84166|NCT02184338|"     Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising     oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in     healthy male subjects   "
84167|NCT02184325|"     Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets,     in children of 6 to 14 years, comparing a given formula with an improved one with reduced     mineral content (qualitatively equivalent to the first one) and a comparator product.   "
84168|NCT02184312|"     Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily)     and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to     estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE®     tablet as well as to 400 mg Nevirapine extended release tablet   "
84169|NCT02184299|"     Study to determine the incidence of rash between the group receiving nevirapine without     prednisone and the group receiving nevirapine with prednisone   "
84170|NCT02184286|"     The objectives of this study are to determine the effects of nevirapine on the steady-state     pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the     steady-state pharmacokinetics of nevirapine. This study will also evaluate the     pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical     controls treated with nevirapine but without saquinavir-sgc.   "
84171|NCT02184273|"     Study to assess the analgesic efficacy in the prevention of postoperative pain in children     undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of     Metamizol in this group of patients.   "
84173|NCT02184247|"     Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release     theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg     theophylline anhydrous (sustained-release product) by comparing the rate and extent of     absorption of theophylline based on both single and multiple-dose profiles.   "
84174|NCT02184234|"     Main objective: Safety and tolerability of Antistax® film coated tablets      Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of     chronic venous insufficiency   "
84188|NCT02184052|"     Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment     of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful     inflammatory conditions.   "
84189|NCT02183077|"     Study to gain information on the percutaneous absorption of meloxicam after administration of     a topical gel over 7 days.   "
84178|NCT02184182|"     One of the limiting factors in the execution of a liver resection, in particular an extended     liver resection, it's represented by the future remnant liver (FRL) after hepatic surgery. In     cases of normal organ function an FRL of 25% is considered sufficient. In case of impaired     hepatic function or a history of chemotherapy, it is considered safe if at least of 40%.      Many strategies have been developed and proposed to increase the resectability in patients     undergoing major liver resections.      One of these is a new two-stage technique proposed recently by a group of German surgeons.     This approach consists in the ligation of the right portal vein associated with resection of     the liver along the falciform ligament (step 1). Step 2, after a period of 9 days (median -     5-25 days), after a volumetric CT to ensure an adeguate hypertrophy of the left lateral lobe     due to the combination of right portal occlusion and segment 4 devascularization, the patient     undergo a right trisectionectomy. The hypertrophy of the left lateral lobe is shown to be of     74%, higher than any other techniques of ligation or portal embolizatiol proposed in the     literature.      On the basis of the clinical experiences reported the investigators designed a new protocol     of two-stage hepatic resection for the treatment of primary or secondary tumors of the right     lobe. Step1: laparoscopic radio frequency / microwave ablation of the future transection     plane between segment 4 and left lateral lobe and surgical ligation or embolization of the     right portal vein. The ablation has the purpose to devascularize the segment 4 and has the     same significance of the resection of the liver along the falciform ligament described by the     Regensburg group.      Step2: After a period of time of 9 ± 2 days, following a volumetric CT showing an adequate     liver volume gain (ratio FRL / patient body weight> 0.5), the patient undergo the     second-stage surgery: laparoscopic/ laparotomic right trisectionectomy.   "
84179|NCT02184169|"     The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn     infants recovering from congenital heart surgery. Currently, we utilize important but     unsophisticated measures, such as vital signs and lactate measurements, to monitor these     patients. Although they are useful in categorizing patients as well or unwell, these signs     currently lack the power quantify a patient's risk for cardiac arrest. More to the point,     they are mostly indirect measures of what we really are assessing, which is tissue oxygen     delivery.      Our group has signiﬁcant expertise with devices which quantify the amount of oxygen that a     baby consumes every minute. Historically, these values are more commonly used in combination     with other measures to assess nutritional and metabolism status. In critically ill patients,     however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen     their circulation delivers. This may represent a critical relationship, which has been     previously described, but not exploited for the purpose of identifying patients with     critically low oxygen delivery.      The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely     and precisely measured continuously in newborns undergoing one of two common congenital heart     surgeries, (2) to determine whether postoperative circulatory failure is associated with a     precedent change in oxygen consumption, and (3) to determine whether the addition of the     oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to     standardly measured parameters will add power in predicting which patients will experience     postoperative circulatory failure.      If successful, this study may improve our capacity to non-invasively and continuously monitor     patients following the highest risk congenital heart surgeries, and in the future,to create     an algorithm which quantiﬁes a patients risk for having a cardiac arrest. This may permit     providers to intervene on these patients earlier, improving the morbidity and mortality     associated with congenital heart disease.   "
84180|NCT02184156|"     In this Phase I/Phase II clinical trial, 7 eligible patients with OA of the knee will receive     Ampion™ 4 mL administered as three IA injections, 2 weeks apart. In the absence of serious     drug-related AEs of unanticipated drug-related AEs, enrollment will be initiated in Phase II     of the study.      In Phase II, a total of 30 eligible patients with OA knee pain will be randomized 1:1 to     receive either the active drug (Ampion™ 4 mL) or placebo as three IA injections, 2 weeks     apart.   "
84181|NCT02184143|"     The overall objective of this study is to conduct a two-group randomized control trial (RCT)     to compare which of two treatments provided by telephone - a cognitive-behavioral based     physical therapy (CBPT) program focusing on self-management strategies or an education     program about postoperative recovery - are more effective for improving patient-centered     outcomes in older adults recovering from lumbar spine surgery for degenerative conditions.     Our central hypothesis is that the CBPT intervention focusing on self-management will     decrease pain and disability and improve general health, physical activity and physical     function in community-dwelling adults undergoing spine surgery, through reductions in fear of     movement and increases in pain self-efficacy.   "
84226|NCT02183818|"     We aim to use an integrated network systems approach to analyze certain existing small airway     epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene expression,     microRNA and metabolomic levels, to develop an initial model of network connectivities and     key network pressure points relevant to SAE biology in health and disease.   "
84182|NCT02184130|"     The long-term goal of this research is to advance our knowledge of how information from the     labyrinth is brought to perception and how adaptation to vestibular imbalance influences     motion sensation. Patients with vestibular disorders frequently have disabling disturbances     of perception. Related to these symptoms is that large areas of the cerebral hemispheres and     the cerebellum receive information from the vestibular, visual and somatosensory systems that     is integrated within a vestibular cortical network into an accurate perception of spatial     orientation. Interrupting the pathways that process information about the direction of     gravity and angular velocity leads to impairment of the internal estimate of gravity and the     perception of body motion. The strategy of this research is to use repetitive transcranial     magnetic stimulation (rTMS) to produce transient focal lesions that allow study of acute loss     of function within the central vestibular pathways at the very beginning of adaptation. Our     underlying hypothesis is that the immediate effects of a lesion in the cerebellum will be to     affect ocular motor control of vestibular reflexes and perception alike but with a cortical     lesion there will be dissociation between ocular motor control and perception. This research     helps to understand the mechanisms involved in the perception of vestibular information and     the cerebellar influence on processing vestibular input and offers a unique opportunity to     make major inroads into the understanding and eventually treatment of the often     incapacitating symptoms of patients with vestibular disease   "
84183|NCT02184117|"     The purpose of this study is to determine the diagnostic performances of iodine contrast     medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be     measured using standard adenosine. We hypothesize that contrast FFR will offer superior     diagnostic agreement compared to resting conditions.   "
84184|NCT02184104|"     The purpose of this study is to determine how fast caffeine gets into your body with a     product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then     put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is     deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the     membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the     absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy     drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your     blood. You will also be asked to fill out some scales to measure the effects you feel after     the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster     than after an energy drink.   "
84259|NCT02183389|"     To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic     parameters of warfarin   "
84190|NCT02183064|"     Study to compare the percentage of treatment successes or failures in patients randomized to     meloxicam 7.5 mg vs. usual care prescription NSAIDs. Additionally, health care utilization,     efficacy and safety of patients in a managed healthcare setting with osteoarthritis (OA) of     the hip, knee, hand or spine will be assessed.   "
84191|NCT02183051|"     To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and     1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg     administered in a single dose, over an observation period of 6 hours in the treatment of pain     after surgery of the third molar.   "
84192|NCT02183038|"     Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15     mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non     bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.   "
84193|NCT02183025|"     To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with     Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation     period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea   "
84194|NCT02183012|"     -  Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet          (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under          fasted conditions.        -  Study to determine the relative bioavailability of ibuprofen following single          administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg          ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.        -  Study to determine the relative bioavailability of ibuprofen following single          administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg          ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet          (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.        -  Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three          formulations.   "
84195|NCT02182999|"     The aim of this study is to investigate the effect of continuous wound infiltration with     ropivacaine in comparison to standard pain management after elective distal metatarsal     osteotomy for postoperative pain control.   "
84196|NCT02182986|"     Solid organ transplantation is an important therapeutic option for children with a variety of     end stage diseases. However, the same immunosuppressive medications that are required to     prevent the child's immune system from attacking and rejecting the transplanted organ can     predispose these individuals to developing a very serious cancer that is linked to     Epstein-Barr virus (EBV).   "
84227|NCT02183805|"     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop     growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.   "
84197|NCT02182973|"     This study is designed to develop pilot data on the acceptability and benefit of donor human     milk for infants undergoing pharmacologic treatment for NAS. Specifically, gastrointestinal     (GI) sub-scores, as well as total scores, will be compared between infants historically fed     formula and those enrolled in a 2-week donor human milk study period.      Purpose of study: to test the following null hypothesis:      Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to     opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan     scoring tool when compared to (historic) infants fed formula.      A rejection of the null hypothesis will be used to design a randomized trial of donor human     milk in infants with NAS.   "
84198|NCT02182960|"     Pharmacokinetics (relative bioavailability), safety and tolerability   "
84199|NCT02182947|"     Most of the studies evaluating the roles of MRE and WCE conducted in pediatric patients have     been retrospective with the main goal of making a diagnosis in patients with suspected IBD.     The current study is the first prospective study in children with known IBD assessing the     roles of MRE and WCE in identifying disease exacerbation. This study will help to identify if     capsule endoscopy is superior or complementary to MRE in the evaluation of suspected disease     exacerbation in IBD patients.   "
84200|NCT02182934|"     To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy,     recreational sports people and to assess the safety of the product.   "
84201|NCT02182921|"     The purpose of this study is to evaluate the visual outcome of the cataract surgery,     including best uncorrected and corrected visual acuity, spherical equivalent, wavefront     aberration and other measurements.   "
84202|NCT02182908|"     The primary aim of the study is to determine if the evolutivity of global and segmentary     captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is     predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally     and segmentary in angioscan.   "
84203|NCT02182895|"     The purpose of this research study is to test the safety and efficacy of a drug called     saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized     patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c     ≤7.0% on ≤ 2 non-insulin agents at home.   "
84204|NCT02182882|"     Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in     healthy, recreational sportspeople and to assess the safety of the product   "
84205|NCT02182869|"     Study to evaluate the safety of combivent delivered in two different formulations     (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI),     using a cumulative dose response model in patients with COPD.   "
84206|NCT02182856|"     Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with     COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen     saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary     disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.   "
84207|NCT02182843|"     The purpose of this study is to assess the clinical and radiographic outcomes in patients who     undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft     spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to     published data for autograft in NDI (Neck Disability Index) improvement and radiographic     success of fusion.   "
84208|NCT02182830|"     This trial is designed to investigate the efficacy and safety of empagliflozin compared with     placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since     hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular     complications, assessment of both glucose and BP lowering effects of empagliflozin in     hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically     highly relevant, new information for the use of empagliflozin.      Essential hypertension is four times more common in African Americans than in Caucasians.      One of the risk factors for hypertension is sodium sensitivity and approximately one third of     the essential hypertensive population is responsive to sodium intake. There is a higher     association of hypertension with sodium sensitivity in African American patients with type 2     Diabetes Mellitus.      The treatment duration of this trial (24 weeks) will enable assessment of the clinically     relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic     control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP     (DBP) at 12 and 24 weeks.   "
84209|NCT02184039|"     Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with     rheumatic diseases.   "
84210|NCT02184026|"     The study implements a trauma-related nightmare treatment for children aged 8 to 13 years.     Relevant outcome progress and outcome measures on symptoms, nightmare distress and duration,     academic indicators, and sleep quality will be examined.   "
84211|NCT02184013|"     This is a pilot study to assess the usefulness of ECG mapping, and enhanced MRI and PET scan     imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial     fibrillation and in guiding an innovative AF catheter ablation strategy.      It is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis     with enhanced imaging and performing an individualized innovative AF catheter ablation will     result in higher procedural success rates.   "
84212|NCT02184000|"     AIM: To evaluate the role of Strain Elastography in the assessment of liver fibrosis in     chronic hepatopathy   "
84239|NCT02183649|"     The primary objective of this trial was to investigate the potential effects of pentoxyverine     on the ECGs of healthy subjects. A secondary objective was the exploration of safety and     tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for the     explanation of ECG effects.   "
84240|NCT02183636|"     Determination of the relative bioavailability of 2 different formulations of a 5 mg     linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5     and formulation C8, compared with the mono-components linagliptin and pioglitazone     administered together   "
84241|NCT02183623|"     Investigation of the multiple dose pharmacokinetics, safety and tolerability of simvastatin     and simvastatin acid with and without concomitant administration of BI 1356 BS   "
84213|NCT02183987|"     Chronic kidney disease (CKD) and its end stage of kidney failure requiring dialysis are     important contributors to morbidity, mortality and health care costs. Over the last two     decades, there has been a strong secular trend in the earlier initiation of dialysis for     treatment of kidney failure from progressive CKD. These trends have occurred in spite of     evidence showing harms with early dialysis initiation and increased health care costs.     Recently, investigators from the Canadian Society of Nephrology, including study     co-investigators, have proposed clinical practice guidelines to recommend an     intent-to-defer approach for dialysis initiation. Whether these guidelines require an     active knowledge translation strategy or they will simply translate through passive     dissemination is unknown.      In the investigators' proposed national cluster parallel group randomized clinical trial, we     will randomize CKD clinics across Canada to an active knowledge translation strategy to defer     dialysis initiation or passive dissemination of guidelines (current practice). The unit of     observation will be the patient (i.e., outcomes will be measured at the level of an     individual patient), and the unit of randomization will be at the level of the     multidisciplinary CKD clinic. The investigators will then evaluate the kidney function     (estimated glomerular filtration rate - eGFR) at dialysis initiation for all dialysis starts     originating from these clinics to examine whether our KT strategy is safe and effective at     delaying dialysis initiation. Our active KT strategy, if effective, will have a significant     impact on patient morbidity and health care costs.      The investigators' hypothesis and specific aims are as follows:      Hypothesis: The investigators hypothesize that the clinics randomized to the active KT     strategy will start a greater proportion of patients on dialysis later (eGFR below 10.5     ml/min/1.73m2) compared to the control.      Aim 1 - Efficacy: To compare the impact of an active KT intervention with passive guideline     release on the proportion of patients followed by a Nephrologist ( > 3 months) who start     dialysis with an eGFR >10.5ml/min/1.73 m2 across the randomized CKD clinics (clusters) in     Canada.      Aim 2 - Safety: To compare the impact of an active KT intervention with passive guideline     release on safe dialysis initiation (acute unplanned dialysis starts) across the randomized     CKD clinics in Canada.   "
84214|NCT02183974|"     The aim of the study was detection of pepsin in effusion in children with OME using Peptest     as new quick and cheap method of detection and comparison results with results of other     studies in which pepsin was detected by more demanding methods. Such a type of study hasn't     been done so far.   "
84215|NCT02183961|"     Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion     (OME) using three different diagnostic methods and selection of the group of patients with     severe EER who could potentially benefit from antireflux therapy.   "
84216|NCT02183948|"     The purpose is to test whether oxytocin has an effect on masked facial expressions   "
84217|NCT02183935|"     Obesity and its complications have a significant effect on morbidity and mortality in these     subjects. Especially at risk are subjects with extremely increased BMI (above 99th percentile     for age and gender in adolescents). In these subjects classical treatment with diet and     cognitive therapy has a limited effect. Bariatric procedures, at the moment, are the only     feasible therapeutic possibility.      Bariatric procedures are based on several principles; restrictive, malabsorptive and     combined. They can be surgical or endoscopic. The later are used in subjects that do not     qualify for surgical procedures that decline them or are used before a planed definite     bariatric procedure.      Duodena-jejunal liner (DJL) is an endoscopic tool, that is efficiently and safely used to     decrease body weight and ameliorated obesity complications, especially those associated with     diabetic state.      Aims of the study are:        -  To determine (short and long-term) efficacy of DJL in decreasing body weight in          adolescents.        -  To determine (short and long-term) efficacy of DJL in ameliorating complications of          morbid obesity - abnormal glucose metabolism, dislipidemia, altered adipokine secretion          pattern, altered secretion pattern of gastrointestinal hormones in adolescents.        -  To visualize functional alternations in the selected central nervous system regions          associated with appetite regulation upon insertion of DJL.   "
84218|NCT02183922|"     Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with     microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body     composition, insulin resistance and lipid profile in women with metabolic syndrome and     genotype Pro12Pro in the PPAR gamma 2 gene.   "
84219|NCT02183909|"     The overall goal of the CRUSH project is to enhance and extend a response to the local     HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions     across the continuum of HIV prevention and care, targeting individuals and communities most     vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California     San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key     community-based organizations, are engaging in a participatory partnership to enhance and     implement HIV services which target the East Bay's highest risk population- young men who     have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a     combination of program approaches to address the sexual health care needs of young gay men of     color and their sexual partners by enhancing the current program activities of the Downtown     Youth Clinic (DYC).      We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC     services structure in two ways. We intend to expand HIV testing, and linkage to and retention     in care for youth who test HIV positive, providing them with intensive risk-reduction     counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further     HIV transmission. And we intend for the first time to offer a comprehensive combination     package of preventive services to HIV-negative youth, including routine accesses to HIV/STI     screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).      The CRUSH Project will also have a substudy that will enroll HIV-negative participants who     are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of     a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual     acquisition of HIV-1 in Y/MSM of color.   "
84220|NCT02183896|"     The purpose of this research project is to assess the effectiveness of intra-articular     injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our     hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral     healing following microfracture performed during femoroacetabular impingement (FAI) hip     arthroscopy.   "
84221|NCT02183883|"     To assess if targeting activating EGFR and HER2 mutations in Non-Small Cell Lung Cancer     (NSCLC) is more effective when these mutations are truncal dominant mutations (≥50%), as     opposed to non-dominant (≥5 to <50%) or low frequency mutations (<5%).      This trial will only be available to patients registered to the TRACERx study (NCT01888601).   "
84222|NCT02183870|"     EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients     with adenocarcinoma of the lung harbouring ROS1 translocations. Patients will be treated with     250mg crizotinib bid until progression or intolerable toxicity.   "
84223|NCT02183857|"     The use of ultrasound guidance by senior residents learning the technique of femoral artery     catheterization is superior to the landmark technique.   "
84224|NCT02183844|"     It is important that individuals with serious mental illness make informed choices among     alternative healthcare treatments based on their preferences. However, at present,     individuals' preferences are often not being elicited, nor used to guide which treatments are     made available. In this pilot project, the investigators implement and evaluate a     computerized method for assessing treatment preferences of individuals with schizophrenia.     The investigators use weight management treatments for this initial test of the system. If     this assessment method is found to predict treatment use and satisfaction, it can be used to     guide implementation of treatments that improve outcomes while meeting individuals'     preferences.   "
84228|NCT02183792|"     Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with     worse prognosis. In addition to its prognostic value, hyponatremia may have importance during     the acute management of HF. We've recently shown that acute or chronic hyponatremia,     especially <130 mEq/L, was associated with higher loop diuretic dose requirements and more     frequent need for escalation of the diuretic regimen to achieve the same level of diuresis as     normonatremic HF patients. Aquaresis with tolvaptan represents a potentially advantageous     approach to the management of volume overload in HF, especially in patients presenting with     concomitant hyponatremia. The purpose of the current study is to prospectively evaluate the     comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to     conventional diuresis with a furosemide-based regimen on short-term clinical and treatment     outcomes in hyponatremic acute HF patients.      This will be a prospective, open-label, parallel-group, randomized study comparing a     tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based     regimen of furosemide. Up to 55 (target sample size of 50) adult subjects admitted with acute     HF and signs of volume overload, and serum sodium less than 135 mEq/L will be randomized to     tolvaptan or furosemide treatment arms. The initial 24 hours of study treatment will compare     tolvaptan monotherapy to furosemide monotherapy. After the initial 24 hours, treatment     regimens may be altered to achieve desired clinical goals. Patients will be followed for up     to 96 hours and at discharge for study purposes.   "
84229|NCT02183779|"     The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids     (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud     phenomena and healthy volunteers, by studying hyperaemic postocclusive response after     microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.   "
84230|NCT02183766|"     Some prebiotics are useful for improving symptoms related to constipation, but clinical     trials including infants and older children are scarce. A double-blind, placebo-controlled,     crossover clinical trial was conducted to evaluate the effect of galactooligosaccharides     (GOS) on functional constipation in children and adolescents. Twenty children aged 4 to 16     years of age, who spontaneously sought medical care at a primary healthcare unit, received     1.7g GOS or placebo (Maltodextrin) treatment for 30 days, followed by a 15-day washout period     and a 30-day use of an alternative product. A clinical score was calculated at baseline, at     the 15th (D15) and 30th (D30) day of each period, to assess bowel movement frequency,     straining/ pain during defecation and stool consistency. Oral anal transit time with     activated charcoal was determined at baseline and D30 of each period.   "
84231|NCT02183753|"     This study is focused on the pathophysiology underlying the association between exposure to     particulate pollutants and risk for/response to viral infection. The investigators     hypothesize that exposure to wood smoke particles (WSP) enhances influenza virus-induced     granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production.     Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project,     the purpose of the study is also to test novel assays of granulocyte activation (Doershuk     lab) and lipid mediator activation (Albritton lab) which have not previously been used in     this type of research.      Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo     controlled study comparing NLF granulocyte responses to LAIV administered after either WSP or     clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean air),     followed by a standardized dose of LAIV and serial post-infection sampling of nasal lavage     fluids, nasal biopsy and blood   "
84232|NCT02183740|"     Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot     be explained by co-morbidity or anatomical and psychological changes of aging alone. In the     nursing home population previous studies suggest a prevalence between 10 and 69%, but is most     often reported to be between 40 and 55%. FI leads to a high direct and indirect economic     burden to the health-care system, and is an important cause og institutionalization of the     elderly patients. In addition, FI is associated with shame, social isolation and reduced     quality of life.      The importance of identifying treatable causes of FI in the frail elderly, rather than just     managing passively, is strongly emphasized. It is indicated that the level of awareness among     health personnel regarding appropriate assessment and treatment options is limited, and that     FI is considered a normal part of aging.      This study is based on the assumption that FI among nursing home patients can be prevented,     cured or ameliorated by offering nursing home staff knowledge of best practise. The primary     objective of the study is to test the hypothesis that a multifaceted educational program for     staff on assessment and treatment of FI, is associated with a reduction in patients'     frequency of FI.      The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated     cross-sectional approach.The results will be analysed according to multilevel and     longitudinal modelling, and the study will use mixed effect models with the cluster treated     as a random effect.   "
84233|NCT02183727|"     The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament     versus Hamstring Autograft for treatment of acute rupture of the ACL.   "
84234|NCT02183714|"     To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to     placebo in patients with mild to moderate insomnia.   "
84235|NCT02183701|"     The general aim and clinical objective of this trial is to determine the effect of     telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on     reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed     by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff     measurements at the end of the treatment.   "
84236|NCT02183688|"     To confirm the combination rationale for the combination of ASA + paracetamol + caffeine     compared with the combination of ASA + paracetamol and the individual substances ASA,     paracetamol, caffeine, and placebo administered orally to headache patients for two headache     episodes   "
84237|NCT02183675|"     To assess drug drug interaction through pharmacokinetics investigation at steady state of     Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations     in healthy Japanese male subjects   "
84238|NCT02183662|"     To investigate safety and pharmacokinetics of BI 224436 ZW   "
84242|NCT02183610|"     To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and     radioactivity including excretion mass balance, excretion pathways and metabolism following     the intravenous and oral administration of [14C] BI 1356 BS   "
84246|NCT02183558|"     Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy,     insulin sensitivity decreases. The investigators examine glucose metabolism during oral     glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective     cohort of pregnant women with PCOS and controls.   "
84247|NCT02183545|"     The objective of this single rising dose study (SRD) is to investigate safety, tolerability,     and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.   "
84248|NCT02183532|"     Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of     5 mg in Chinese healthy subjects   "
84249|NCT02183519|"     The purpose of this research study is to test cough function in individuals with Parkinson's     disease and healthy older adults. Cough is a complex, defensive function which involves     movement of the chest and lungs. The investigators want to compare the movement of the chest     wall and the lungs during voluntary and reflex cough.      The long-term goal of this research is to develop treatments for people with cough     dysfunction. Cough dysfunction increases the risk for respiratory infections such as     pneumonia. The results from this study will provide information to help researchers     understand the difference between reflex and voluntary cough more fully.   "
84250|NCT02183506|"     Investigate the bioavailability of BI 1356 BS and of metformin after concomitant multiple     oral administration of 10 mg BI 1356 BS tablets and 3 x 850 mg metformin in comparison to BI     1356 BS and metformin given alone   "
84251|NCT02183493|"     To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg     BI 1356 tablet administered as a single dose   "
84252|NCT02183480|"     Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg     tablets of linagliptin   "
84253|NCT02183467|"     Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval   "
84254|NCT02183454|"     To collect post marketing surveillance data on patients receiving at least one Combo     Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data     will be collected in order to assess the long term safety and performance of the Combo Stent     in routine clinical practice.   "
84255|NCT02183441|"     Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir     on the pharmacokinetics of BI 1356   "
84256|NCT02183428|"     The objective of this study was to investigate the effect of multiple doses BI 1356 given     once daily in the estimated highest therapeutic dose of 5 mg until steady state on the     pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of     1.75 mg glyburide. In addition, the effect of glyburide as a single oral dose of 1.75 mg     being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was     investigated. Pharmacokinetic profiles of glyburide were determined when given alone or in     combination with BI 1356. Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD     1750 were determined at steady state of BI 1356 when given alone or in combination with     glyburide.   "
84257|NCT02183415|"     Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI     1356 BS during 4 week treatment duration   "
84258|NCT02183402|"     The purpose of this study is to investigate the pharmacokinetics, safety and tolerability of     digoxin with and without co-administration of BI 1356. Additionally the steady state     pharmacokinetics of BI 1356 when co-administered with digoxin will be determined.   "
84260|NCT02183376|"     To investigate the influence of mild, moderate, and severe liver impairment on the     pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with     normal hepatic function after single or multiple oral administration of 5 mg linagliptin     tablets   "
84261|NCT02183363|"     Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations     (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF     IIb   "
84262|NCT02183350|"     The primary objective of the current study was to investigate the safety and tolerability of     BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and     10 mg over 12 days in male patients with type 2 diabetes.   "
84263|NCT02183337|"     Study to investigate the bioavailability of BI 1356 with and without co-administration of     pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI     1356   "
84264|NCT02183324|"     Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356     BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese     patients with type 2 diabetes mellitus.   "
84265|NCT02183311|"     Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356     BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg,     and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)   "
84266|NCT02183298|"     Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI     1356 as formulation for intravenous administration   "
84267|NCT02183285|"     To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and     film-coated tablets   "
84268|NCT02183272|"     The objective of the current program of research will be to test whether intranasal ketamine     treatment is more effective than placebo in reducing suicidal ideation in suicidal patients     presenting for acute treatment in emergency department settings. Secondary objectives will     test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine     and the correlation of speech patterns and facial movement patterns with subjective     reductions in suicidal ideation after ketamine treatment.   "
84269|NCT02183259|"     To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma     concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to     healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150     CL.   "
84270|NCT02183246|"     Determination of efficacy and safety of porfiromycin versus placebo as an adjuvant to     radiotherapy in postoperative head and neck a cancer patients as well as assessment of     population pharmacokinetic parameters.   "
84273|NCT02183207|"     Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and     easy to perform. However, it is limited by its need to be performed in an endoscopy unit.     E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any     hospital setting and introduced via nasal approach. Our aim is to prove that PEG by     introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at     hospitals and medical facilities without endoscopic units.   "
84274|NCT02183194|"     The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter     (CE mark) for use as intended in the treatment of subjects with clinically significant     hemodialysis vascular access stenosis or occlusion.   "
84275|NCT02183181|"     Primary Objective:      To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg     (Reference, R) following oral administration.      Secondary Objective:      To investigate the safety and tolerability of meloxicam following a single dose of meloxicam     capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese     subjects.   "
84276|NCT02183168|"     Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam     tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with     ankylosing spondylitis   "
84277|NCT02183155|"     The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg     and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an     active control to assess trial sensitivity on bleeding time in healthy subjects. The     secondary aim of this study was to assess effects of treatment on other platelet function and     coagulation parameters.   "
84278|NCT02183142|"     The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic     tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany   "
84279|NCT02183129|"     To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac     100mg SR once daily over a treatment period of 8 weeks   "
84280|NCT02183116|"     To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56     days   "
84281|NCT02183103|"     Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam     rapid releases tablet   "
84282|NCT02183090|"     Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg     meloxicam injection in comparison to the 15 mg oral tablet   "
84283|NCT02182817|"     This prospective cohort study aims to determine if apparently healthy children with no     significant co-morbidities who undergo general anaesthesia for minor surgery before 1 year of     age will develop measurable deficits in neurocognitive development compared to apparently     healthy children with no significant co-morbidities who do not undergo general anaesthesia or     surgery.   "
84284|NCT02182804|"     This descriptive cross sectional study aims to directly compare the diagnostic capability of     the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging     (M-NBI) in the Lugol's voiding lesions.   "
84285|NCT02182791|"     Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl     estradiol (EE)/norethindrone (NET).   "
84286|NCT02182778|"     To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for     unresectable biliary tract cancer.   "
84347|NCT02181985|"     The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase     with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and     half dose tenecteplase combined with abciximab and heparin sodium (group C).   "
84287|NCT02182765|"     Study to determine the effects of 28 days of nevirapine treatment on the steady-state     pharmacokinetics of amprenavir and of abacavir and to further evaluate the pharmacokinetics     of nevirapine in combination with amprenavir and abacavir compared to historical controls     treated with nevirapine but without amprenavir or abacavir. In addition safety/tolerance of     nevirapine, amprenavir and abacavir was to be assessed based on adverse events and clinical     laboratory data.   "
84288|NCT02182752|"     The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine     local anesthetic solution in interscalene brachial plexus block for shoulder surgery.   "
84289|NCT02182739|"     Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug     tolerability.   "
84290|NCT02182726|"     The aim of the study is to investigate        -  the indication for MOBEC in a dose of 15 mg per day        -  the treatments patients were receiving before switching to 15 mg MOBEC        -  how treatment with 15 mg is assessed compared with previous treatment        -  how effective and safe treatment with 15 mg MOBEC is considered   "
84291|NCT02182713|"     The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized     120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide     confers significant additional protection against metacholine induced bronchoconstriction in     asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.   "
84292|NCT02182700|"     Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol     sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in     adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.   "
84293|NCT02182687|"     This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial     chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic     liver transplantation. We propose that SBRT will be associated with longer time intervals     between initial treatment and the need for retreatment, compared to TACE, as a bridge to     orthotopic liver transplantation.   "
84294|NCT02182674|"     Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA)     inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two     puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC) inhalation     aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate / per puff). The dose response     profile, safety and pharmacokinetics of Combivent HFA formulation are to be characterized.   "
84295|NCT02182661|"     The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily     the long-term efficacy of Ba253BINEB is also investigated.   "
84296|NCT02182648|"     This research through using bispectral index to guide the induced dose and speed of etomidate     lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical     anesthesia physician.   "
84299|NCT02182609|"     The objectives of this study are:        -  To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128          administered as an intravenous bolus over 10-20 seconds.        -  To determine the biodistribution, pharmacokinetics and radiation dosimetry of          99mTc-rhAnnexin V-128 in normal healthy adult volunteers.   "
84300|NCT02182596|"     For several years, the effective standard induction chemotherapy for AML has been limited to     the association of anthracycline and aracytine. GO is the first effective targeted antibody     used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated     doses of GO used as a single agent for treatment of adult AML patients in first relapse. In     the present study the possibility of combining fractionated doses of GO to escalated doses of     a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.   "
84301|NCT02182583|"     The objective of this study is to investigate the efficacy and safety of Ba253BINEB during     the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan®     aerosol) as the comparator drug.   "
84302|NCT02182570|"     The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment     of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.   "
84303|NCT02182557|"     Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated     with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and     to confirm the appropriateness of dosage of WAL801 Dry Syrup.   "
84304|NCT02182544|"     Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate     on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup     compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry     Syrup.   "
84305|NCT02182531|"     Study to compare the bioavailable fraction of epinastine and pseudoephedrine when     administered as a fixed dose combination in tablet form (new pharmaceutical formulation),     with that obtained with each of these drugs when administered separately to healthy     volunteers.   "
84306|NCT02182518|"     The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg +     Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10     mg alone administered twice daily.   "
84307|NCT02182505|"     Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol     hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium     bromide, 1 puff t.i.d.) administered via Respimat® device gives a bronchodilator response     which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol     hydrobromide + 21 µg ipratropium bromide, 2 puffs t.i.d.) administered via the MDI     (chlorofluorocarbon-metered dose inhaler) with Aerochamber® and that the safety profile is at     least as good when paediatric asthma patients are treated for four weeks.   "
84308|NCT02182492|"     Endoscopic sinus surgery (ESS) is widely considered to be the gold standard in the surgical     management of chronic rhinosinusitis (CRS) that has failed maximal medical therapy.     Nevertheless, the postoperation medical therapy was considered as a crucial procedure for the     success of ESS. Both glucocorticoids and macrolide antibiotics have been recommended for the     treatment of CRS, but their effect as postoperation medical therapies of ESS need more     clinical data to clarify.      The purpose of this prospective, randomized,study is to determine the effect of     glucocorticoids and macrolide antibiotics for the postoperation medical therapy of ESS in     different subtypes of CRS.   "
84309|NCT02182479|"     Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol     hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium     bromide, 1 puff q.i.d.) administered via Respimat® gives a bronchodilator response which is     not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg     ipratropium bromide, 2 puffs q.i.d.) administered via MDI and that the safety profile is at     least as good in asthma patients treated for 12 weeks.   "
84310|NCT02182466|"     Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This     is to investigate safety, quality assurance and quality control of colon capsule endoscopy.   "
84311|NCT02182453|"     Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI     10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10,     25, and 100 mg).   "
84312|NCT02182440|"     The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is     effective and save, and to determine the most effective dose, in the treatment of patients     with acute kidney injury caused by sepsis.   "
84313|NCT02182427|"     Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide     and results in poor outcomes. However there is no universal method for diagnosing     malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition.     The goal of this project is to determine whether these characteristics are the best     indicators to identify malnutrition or if there are other factors that may better identify     malnutrition. Because there is no gold standard definition for malnutrition, the     investigators will compare the characteristics against outcomes such as length of stay,     hospital readmission and death. Outcomes are also influenced by disease state, therefore,     information on what brought the patient to the hospital and what happened to them in the     hospital will be collected that allows the investigators to separate the effect of     malnutrition from disease. The hypothesis for this study is that the malnutrition clinical     characteristics and diagnosis criteria, as presented by the experts, are valid and reliable     principles for the diagnosis of adult under-nutrition.   "
84314|NCT02182414|"     Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial     formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet     formulation (trial formulation I) in healthy male volunteers with the aim to identify the     best formulation for further drug development (formulation finding part / trial part 1) and     to investigate the effect of food on the relative bioavailability of the most promising one     of these trial formulation II prototypes (food-effect part / trial part 2).   "
84315|NCT02182401|"     Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and     BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI     207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe     substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).   "
84318|NCT02182362|"     The main objective was to investigate the safety, tolerability and the pharmacokinetics (PK)     of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS)     following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20     mg, 48 mg, 120 mg, and 240 mg. Additionally, the safety, tolerability, and the PK of the     highest tolerated dose of BI 201335 NA (determined during the multiple-rising-dose phase)     were assessed in healthy male subjects with GS over a 28-day continuous drug administration     period.   "
84319|NCT02182349|"     Study to determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including     excretion mass balance, excretion pathways and metabolism following the oral administration     of [14C]-BI 201335 at steady state.   "
84320|NCT02182336|"     The objective of this trial was to quantify the effect of oral single-dose (480 mg) and     steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and     P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for     the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin were     assessed.   "
84321|NCT02182323|"     The objective of this study was to investigate the safety, tolerability, and pharmacokinetics     of BI 201335 NA following administration of single rising doses from 4 mg to 1200 mg. In     addition, the food effect on the bioavailability of BI 201335 NA (480 mg) was investigated.   "
84322|NCT02182310|"     To demonstrate that BI 201335 does not prolong the QT interval more than placebo.      To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects     (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the     cross-over part of the trial.   "
84323|NCT02182297|"     The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of     BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA     in healthy Japanese male volunteers.   "
84324|NCT02182284|"     The objective of this study was to establish the relative bioavailability of a new soft     gelatin capsule (SGC) formulation of BI 201335 NA compared to the current solution     formulation (powder in bottle, PIB) for two doses (40 mg, 240 mg) in a parallel, two-way     cross-over study design.   "
84325|NCT02182271|"     The objective of the current study is to investigate safety, tolerability, and     pharmacokinetics of BI 201335 ZW following administration of single rising doses from 5 mg to     1500 mg. In addition Two stage intra-subject bioavailability comparison of 600 mg BI 201335     ZW as a liquid formulation given with and without food.   "
84326|NCT02182258|"     The primary objective of this trial was to assess the safety and tolerability of BIBF 1120     administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute     bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A     secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single     iv dosing, including dose proportionality.   "
84327|NCT02182245|"     The primary objectives of this trial were to determine the safety, tolerability, and MTD of     BIBF 1120 when added to standard therapy with carboplatin and paclitaxel   "
84328|NCT02182232|"     The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination     with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment   "
84329|NCT02182219|"     The primary objective of this study was to determine the safety and Maximum tolerated dose     (MTD) of BIBF 1120 combination therapy with docetaxel and prednisone in patients with hormone     refractory prostate cancer. Secondary objectives were to characterise the pharmacokinetic     profiles of BIBF 1120 and docetaxel and possible Pharmacokinetic (PK) interactions between     BIBF 1120 and docetaxel and to obtain preliminary information on anti-tumour activity.   "
84330|NCT02182206|"     Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120,     pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI))   "
84331|NCT02182193|"     To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120     soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120     drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo     correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male     volunteers (if feasible)   "
84332|NCT02182180|"     The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF,     the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and     other body fluids and tissues from people who have been seriously injured or ill. The samples     will be used to develop and assess tests and/or tools that doctors can use to decide the best     treatment plan for seriously injured or ill military personnel and for civilians. Additonal     protocols to use the samples will be submitted as separate protocols.   "
84333|NCT02182167|"     We will conduct a randomized placebo controlled trial to determine whether administration of     intravenous (IV) NAC to participants with TB DIH, in dosages similar to that used in     paracetamol poisoning, can improve recovery from hepatotoxicity.   "
84334|NCT02182154|"     To assess the metabolic profile,      to obtain the mass balance after oral administration,      to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and     faeces,      to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if     feasible,      to determine the protein binding of [14C]-radioactivity,      to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a     single oral administration of [14C]-BIBF 1120 in healthy volunteers   "
84335|NCT02182141|"     Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120,     pharmacodynamics   "
84336|NCT02182128|"     Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as     safe and tolerable treatment in Japanese patients with advanced solid tumours, overall     safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.   "
84365|NCT02181751|"     Our goal in this study is to decrease the severity of Post-Traumatic Stress Disorder symptoms     in sexually abused children between the ages of 8-12. We also aim to improve children's     quality of life, decrease levels of anxiety and depression as well as improve their levels of     attachment.   "
84366|NCT02181738|"     The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously     treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma     subjects.   "
84337|NCT02182115|"     Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity     and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year     over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such     infections double the length of hospitalization and risk of dying, and increase U.S. health     care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by     either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers     of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA     SSI. A potential prevention approach is routine pre-operative screening of patients, followed     by decolonization of identified SA carriers.   "
84338|NCT02182102|"     The primary objective was to determine the safety, tolerability and maximum tolerate dose     (MTD) of BIBF 1120 in combination with pemetrexed. Secondary objectives were to characterize     the pharmacokinetic profiles of BIBF 1120 and pemetrexed and to obtain preliminary     anti-tumour efficacy information.   "
84339|NCT02182089|"     The overall goal is to evaluate the predictive accuracy of a measure of autoregulatory     adequacy derived from CVInsight and compare it with other measures in recognizing hypotensive     events during hemodialysis..   "
84340|NCT02182076|"     Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120     soft gelatine capsule with food effect (BA) in healthy subjects respectively.   "
84341|NCT02182063|"     The aim of this study was to evaluate the efficacy of two different doses of BIBF 1120 (250     mg twice daily versus 150 mg twice daily) in an exploratory manner. Safety, quality of life     and pharmacokinetic parameters on a sub-sample of 20 patients were also analysed for the two     different doses.   "
84342|NCT02182050|"     The overall purpose of this phase II trial was to evaluate the efficacy of 250 mg BIBF 1120     twice daily (BID) versus 150 mg BIBF 1120 BID in patients with advanced non-small-cell lung     cancer (NSCLC) who had failed at least one prior chemotherapy regimen. In addition, safety     data for the two different dosages were collected and analysed.   "
84343|NCT02182037|"     A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011     BS, on coagulation parameters.   "
84344|NCT02182024|"     To assess the effect of different degrees of renal impairment on the pharmacokinetics and     pharmacodynamics of dabigatran etexilate administered orally.   "
84345|NCT02182011|"     Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and     streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2     hours after the start of treatment versus baseline values.      Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change     from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence     of adverse events (AE's), in -hospital complications, major or minor bleedings and serious     adverse events.   "
84346|NCT02181998|"     The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety     and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A)     and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective     in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.   "
84351|NCT02181933|"     The primary objective of the study was to evaluate the efficacy of nevirapine versus ZDV+3TC     (Zidovudine + Lamivudine), when administered in labor and again at postdelivery, in reducing     peripartum mother to child transmission of HIV (Human Immunodeficiency Virus).      The secondary objective was to assess the overall HIV transmission rate between the 2 groups     (intrauterine, intrapartum and postpartum up to 6 weeks) as well as to explore the     relationship between infection and timing of maternal dose relative to birth, infant feeding     method, maternal peripheral blood viral load, and other potential risk factors for     transmission.      Following the introduction of the second and third Amendments to the Protocol, 2 substudies     were added. The objectives of these substudies were to evaluate the frequency of     resistance-conferring mutations to nevirapine (Amendment 2) and to ZDV+3TC (Amendment 3); to     determine whether there was a reversion of any resistant virus to the wild type; and to     determine if the resistant virus was transmitted from the mother to the child.   "
84352|NCT02181920|"     Study to evaluate the efficacy of metamizole in reducing morphine requirements in patients     with moderate to severe chronic cancer pain in comparison to administration of placebo or     diclofenac.   "
84353|NCT02181907|"     Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX     capsules 10 mg by single administration in healthy volunteers.   "
84367|NCT02181725|"     The purpose of this study is to evaluate whether a multimodal rehabilitation program     effectively reduces functional disability in adolescents with chronic musculoskeletal pain,     compared to care as usual.   "
84368|NCT02181712|"     To assess the safety and feasibility of mesenchymal stem cells therapy in patients with     transplant related bronchiolitis obliteran syndrome (BOS)   "
84369|NCT02181699|"     This is a first in human, non-randomized, open-label, dose escalation study to investigate     the safety, pharmacokinetics, immunogenicity and pharmacodynamics of repeat doses of KHK2823.   "
84370|NCT02181686|"     The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV     lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device     system.   "
84354|NCT02181894|"     Placing artificial airways in infants is often performed under emergent life-saving     conditions, which necessitates a procedure that is both accurate and efficient. Intubations     of the newborn are often necessary before an accurate weight can be reported and estimations     are often inaccurate. The current national standard uses body weight to predict the     appropriate tube depth yet this approach tends to place the tube too deep for the smallest     and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The     consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation,     pneumothoraces and death has been suggested to cost $20 to $54 million annually.      The morbidity and the financial impact suggest an optimal and accurate approach to place ETT     in neonates has not been identified. Other methods to estimate the proper depth of the     orotracheal tube have shown promise yet no comparison studies have been performed.     Identifying the most accurate method to safely place neonatal orotracheal tubes will improve     placement precision and reduce adverse events and their associated costs.      Hypothesis      Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to     tragus length will become the most accurate method for predicting the safe depth of orally     placed neonatal endotracheal tubes.   "
84355|NCT02181881|"     The investigators will pilot test the intervention by randomizing 30 couples to one of three     conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a     standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment     as usual (TAU) assessment-only control condition. After randomization, intervention sessions     will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be     assessed pre/post intervention to evaluate intervention acceptability and feasibility.   "
84356|NCT02181868|"     The mandible bears a wide range of mechanical load from the contraction of masticatory     muscles, and has a significant function in normal chewing movements. Mandibular fractures are     the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial fracture     cases with an average of 62%. The etiology of mandibular fractures mainly includes assaults,     road traffic accidents (RTAs), falls, and sports injuries. Although a wide variance exists in     the reported percentage of anterior mandible fractures, aggregate analysis approximates these     fractures at 17% of all mandibular fractures. The rigid internal fixation (RIF) technique has     become a common treatment for mandibular fractures, in which titanium plates are used in the     operation. Some patients have to remove the titanium plates in a second operation following     bone healing because of sequelae, such as stress shielding. Biodegradable plates and screws     have been developed to eliminate the problems associated with titanium fixtures. In this     study, we aim to compare the clinical performance between biodegradable and titanium fixation     systems after 12 months of follow-up in fixation of mandibular symphysis and parasymphysis     solitary fractures. We also investigate the stress distributions of biodegradable and     titanium fixation systems at mandibular symphysis solitary fracture on the conditions of     intercuspal position, labial teeth occlusion, and premolar and molar occlusion using finite     element analysis.   "
84357|NCT02181855|"     Patients with atypical symptoms of objectified gastroesophageal reflux disease will be     treated by full-thickness gastroplication and the effect of this intervention will be     measured by questionnaires and clinical diagnostics (for example pH/MII).   "
84358|NCT02181842|"     The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the     safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients     with inadequate glycemic control and a prior history of cerebral infarction.   "
84385|NCT02181491|"     There has been recent interest in the role of the 5-HT1B receptor as a possible modulating     factor in cocaine dependence, certainly in preclinical models. The Yale Positron Emission     Tomography (PET) Center has developed a novel 5-HT1B receptor antagonist radioligand,     [11C]-P943, which has been validated in human studies. We hypothesize that the 5-HT1B     receptor plays a key role in cocaine dependence. The long term goal of this project would be     to study pharmacological manipulation of the 5-HT1B receptor as a potential molecular target     for cocaine dependence.   "
88228|NCT02131220|"     The purpose of this study is to determine whether intracoronary selective thrombolysis are     more effective than tirofiban on the coronary flow during primary percutaneous coronary     intervention for the acute myocardial infarction.   "
84359|NCT02181829|"     The purpose of this study is to find out what effects, good and/or bad, radiation has on the     lungs has on the patient and on synovial sarcoma which has spread to the lungs. The standard     treatment for synovial sarcoma which has spread to the lungs is chemotherapy with or without     surgery to remove the tumors in the lungs. However, tumors often come back in the lungs after     chemotherapy and/or surgery. Since synovial sarcoma is known to be sensitive to radiation,     this study is looking at whether radiation therapy which is targeted to the entire lung can     further reduce the chances of the cancer returning. This type of radiation is commonly used     in other types of sarcoma to treat the cancer once it has spread to the lungs and it may be     very useful in synovial sarcoma as well.      In this study, a special type of radiation will be used, called Intensity Modulated Radiation     Therapy (IMRT). With IMRT the radiation beams are more customized to focus more radiation on     the tumor cells while delivering less radiation to areas like the heart. The goal of this     study is also to measure pulmonary toxicity and see if IMRT is feasible and has less     toxicity.   "
84360|NCT02181816|"     The purpose of this survey is to evaluate the safety and efficacy of long-term use of     azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in     hypertensive patients in daily medical practice.   "
84361|NCT02181803|"     This 3-part dose titration study will assess MK-8189 safety, tolerability, pharmacokinetics     (PK), and central nervous system activity. Part 1 will assess MK-8189 administered as     monotherapy in participants with schizophrenia. Part 2 will assess MK-8189 administered as     add-on to atypical antipsychotic treatment in participants with schizophrenia. Part 3 will     assess monotherapy with MK-8189 in healthy participants, including those of Japanese descent.     The primary hypothesis is that there is at least one dose of MK-8189 that is generally safe     and well-tolerated which will have the desired PK parameters in participants with     schizophrenia.   "
84362|NCT02181790|"     Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe     psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be     sufficient for treatment of some patients, psoriasis of the palms and soles is particularly     challenging to treat, and may not respond to acitretin alone.      In this study, the focus is on patients who have psoriasis of the palms and soles, and are     currently taking acitretin. The aim is to initially recruit 10 patients and offer them     treatment with a laser, the excimer laser, to one palm and one sole. Patients will receive     laser treatment twice weekly for a total of 8 weeks, while also taking their acitretin     tablet. If the side treated with the excimer laser shows greater improvement compared to the     other side, the second part of the study will be conducted.      In this second part, another 15 patients will be included. These patients will receive twice     weekly treatments with the excimer laser to one both palms and/or soles, for a total of 8     weeks. The aim is to prove that the addition of excimer laser to treatment with acitretin     will lead to greater improvement of psoriasis on palms and soles.   "
84371|NCT02181673|"     The purpose of this study is to evaluate the efficacy of intravenously (administration of a     fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants     with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with     psoriasis).   "
84372|NCT02181660|"     The objectives of this study are to determine the safety and tolerability of ASP2215 as well     as the maximum tolerated dose (MTD) based on the onset of dose limiting toxicity (DLT) and/or     determine the recommended dose (RD) of ASP2215 for the next phase in subjects with relapsed     or treatment-refractory acute myeloid leukemia (AML).   "
84373|NCT02181647|"     The primary goal of the study is to conduct a rigorous evaluation of the sexual abuse     prevention program entitled, Safe Touches: Personal Safety Training for Children (Safe     Touches). The main study hypothesis is that children who receive the Safe Touches     intervention will show greater improvement on their knowledge of inappropriate touches     compared to children who do not receive the intervention.   "
84374|NCT02181634|"     Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for     curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and     gemcitabine chemotherapy.      The purpose of this study is to evaluate the effectiveness and safety of the combination of     nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the     length of time during and after treatment, that the CCA does not get worse.   "
84375|NCT02181621|"     This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is     better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism     bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.      ◊ Trademark of Smith & Nephew   "
84376|NCT02181608|"     Background:      - Researchers want to see if people with alcohol dependence have more trouble learning to     feel calm, or learn to fear things more easily, than non-alcoholics and to study how early     life stress (ELS) affects these things.      Objective:      - To see if people with alcohol dependence and/or ELS have a harder time learning to feel     calm than people without these conditions.      Eligibility:        -  Adults age 21 65 with diagnosed alcohol dependence, with/without ELS.        -  Healthy volunteers age 21 65 with/without ELS.      Design:        -  All participants will be screened with medical history and physical exam. They will have          blood and urine tests, and a psychological assessment.        -  Participants with alcohol dependence will:        -  be at the NIH Clinical Center for 4 weeks. Then they will have weekly telephone calls          and 3 in-person visits over 3 months.        -  follow the NIH alcohol treatment program during the study. They cannot take psychiatric          medications.        -  rate their alcohol craving, depression, and anxiety throughout the study.        -  have fear conditioning and extinction sessions that use noise and mild electric shock.          Some take place during a functional MRI (fMRI) scan. Participants will lie in a machine          that takes images, while they perform tasks.        -  listen to recordings that describe stressful events. They will rate their feelings and          have blood drawn through an intravenous (IV) line.        -  have their hormone response to stress tested. They will take a pill and get a hormone          via an IV, then have blood drawn.        -  Healthy volunteers will:        -  have 2 inpatient stays, each lasting a few days. They will answer questions about how          they feel.        -  have fear conditioning and extinction sessions, including fMRI.        -  have blood drawn several times.   "
84386|NCT02181478|"     This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal     cell co-transplant in treating patients with hematologic malignancies. Giving low doses of     chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood     and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer     cells. It may also stop the patient's immune system from rejecting the donor's stem cells.     The donated stem cells may replace the patient's immune cells and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also make an immune response against the body's normal cells. Giving cyclosporine and     mycophenolate mofetil at the time of transplant may stop this from happening.   "
84377|NCT02181595|"     Background:      - Women with Primary Ovarian Insufficiency (POI) have ovaries that stopped working normally     before they turned 40. This usually causes infertility, which challenges many women with the     condition to ask themselves, Why me? This kind of question is about our human existence, or     what some call an existential view of life. Researchers have learned that spirituality and     finding existential purpose help women with POI. So does meeting other women with the same     problem. Researchers want to find new ways to help women with POI cope with it.      Objective:      - To develop and test a practice for women with POI called Deep Reading.      Eligibility:      - Women enrolled in another POI protocol, who can read and speak English.      Design:        -  Participants will first have an individual visit or phone call. They will describe          spiritual or existential practices they have done. They will also answer questions about          spiritual and existential health and daily functioning.        -  They will join a group for 6 weekly sessions. Each session will be 60 90 minutes.        -  In each group session, a coordinator will teach participants about Deep Reading. They          will read a piece of up to 1000 words. They will think about the piece and then talk          about it with the group.        -  Between sessions, participants will practice Deep Reading at least once for 15 20          minutes on their own. They will check in once with another group member. They will keep          a log of these activities.        -  After session 3, participants will answer questions online about wellbeing and          satisfaction.        -  At session 6, participants will answer questions online about wellbeing. They will          answer questions about their overall experience.        -  One and 3 months after the sessions end, participants will again complete online          wellbeing questionnaires and report on their continued practice of Deep Reading.   "
84378|NCT02181582|"     Background:      - A brain protein called translocator protein (TSPO) shows changes in some brain diseases. A     radioactive drug called 11C-(R)-PK 11195 is used to take pictures of TSPO using a camera     called positron emission tomography (PET). Researchers want to find out how well 11C-(R)-PK     11195 takes the pictures.      Objective:      - To evaluate the radioactive chemical 11C-(R)-PK 11195.      Eligibility:      - Healthy volunteers ages 18-55.      Design:        -  Participants will be screened with a medical exam.        -  Participants will have scans at up to 4 visits.             -  PET scan using 11C-(R)-PK 11195:                  -  A small tube (catheter) will be put into an artery at the wrist or elbow, by a                    needle. The needle will be removed, leaving only the catheter in the artery.                    Blood samples will be taken through this catheter.                  -  Another catheter will be placed into a vein in the arm or hand.                  -  11C-(R)-PK 11195 will be injected through the second catheter.                  -  The PET scanner is shaped like a doughnut. Participants will lie on a bed that                    slides in and out of it. They may get a plastic mask for their face and head.             -  Participants will receive a dose of emapunil by mouth. Participants will then have               another PET scan.             -  Participants may have a magnetic resonance imaging (MRI) scan. The MRI scanner is a               metal cylinder surrounded by a magnetic field. The participant will lie on a table               that can slide in and out of the cylinder. Participants will get earplugs for the               loud knocking noises.        -  After each scan, participants will get a follow-up phone call. Two to seven days after          taking emapunil, participants will return for a follow-up visit.   "
84390|NCT02181426|"     Ketorolac is administered as current practice to the majority of patients undergoing knee     arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.   "
84391|NCT02181413|"     The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy     on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed     multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial     response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy     (HDT) and autologous stem cell transplant (ASCT).   "
84500|NCT02179983|"     Pulmonary rehabilitation is well established as a treatment in COPD. After exacerbations of     COPD, rehabilitation is associated with reduced frequency of exacerbations and improved     exercise capacity. No data are available in bronchiectasis.      This study will randomly assign patients with bronchiectasis exacerbations to pulmonary     rehabilitation or standard care. The hypothesis is that exercise capacity will be improved by     pulmonary rehabilitation at 8 weeks.   "
84379|NCT02181569|"     Despite research establishing the relationship between sleep disturbances and alcohol use,     there is no clear understanding or model for what occurs once individuals who seek inpatient     alcoholism treatment are discharged from rehabilitation facilities and attempt to integrate     back into their homes and communities. The purpose of this investigation will be to     characterize sleep patterns, perceptions, and beliefs throughout the process of alcohol     rehabilitation. The misuse of alcohol is a global public health concern that compromises both     individual and societal wellbeing, resulting in an estimated 2.5 million deaths annually. The     National Institute on Alcohol Abuse and Alcoholism (NIAAA) distinguishes alcoholism by     craving, loss of control, physical dependence, and tolerance (NIAAA, Alcohol Use Disorders).     The relationship between alcohol use and sleep disturbances is complex and bidirectional, but     sleep disturbances are common among alcoholics during phases of drinking, withdrawal, and     abstinence. Outcome expectancies, behavioral capability, and self-efficacy beliefs are     central constructs in the Social Cognitive Theory and will be measured directly in this study     using both quantitative and qualitative methods. A mixed methods approach will be used to     study the following aims: a) to assess individuals' perceptions of and experiences with sleep     during alcohol rehabilitation, b) to describe sleep patterns, perceptions, and beliefs among     alcohol-dependent individuals throughout the transition from a clinical research facility     providing rehabilitation treatment back to the community, c) to assess whether sleep-related     beliefs and/or behavior of individuals are predictive of sleep quality or relapse to     drinking, and d) to assess whether sleep quality predicts relapse. Adult research     participants admitted to the inpatient behavioral health unit and enrolled on to the NIAAA     intramural study NCT 0010693: Assessment and Treatment of People with Alcohol Drinking     Problems will be recruited for participation in this study (n=215). Sleep quality and     duration will be quantitatively assessed approximately one week prior to discharge from the     inpatient facility and again 4-6 weeks post-discharge. A sub-set of participants will be     asked to wear actiwatches (accelerometers) to provide objective data on sleep throughout the     transition from inpatient to outpatient. In addition to quantitative measures, qualitative     semi-structured interviews will be conducted with a subset of 25 participants (to reach 25     completed cases) within a week of the scheduled discharge date and again four to six weeks     post-discharge to assess perceptions of sleep during recovery. The proposed study will fill a     gap in the literature by characterizing sleep throughout the rehabilitation process and     ongoing maintenance of abstinence.   "
84380|NCT02181556|"     One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI.     The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein,     similar to immunoglobulins, aflibercept, and to assess their tolerance.      Aflibercept is a protein that has already been studied in the treatment of metastatic     colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to     5FU (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the     United States. Its addition to this chemotherapy combination has in fact brought about a     benefit in terms of progression-free survival and overall survival.      The purpose of the study is to evaluate the efficacy and tolerance of this combination rather     in the initial approach to the treatment of metastatic colorectal cancers and hence to     evaluate it as 1st line treatment   "
84381|NCT02181543|"     The purpose of this study is to determine efficacy of intraoperative clonidine to prevent     postoperative agitation in pediatric anesthesia with sevoflurane.   "
84382|NCT02181530|"     This study will use retrospective data to evaluate the safety and efficacy of OZURDEX®     (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal     vein occlusion (RVO) in clinical practice. No intervention will be administered as part of     this study.   "
84387|NCT02181465|"     Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin     gene and to be sensitive to the trophic effects of the gastrin in animal models. The     hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that     will bind gastrin-17, thus preventing the trophic activity of cancer cells.   "
84388|NCT02181452|"     Chronic liver disease/fibrosis can be the result of various causes, and the result is that     the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer®     ultrasound system, is a method that can be used to measure the stiffness of organs in the     body, for example the liver.      This study will evaluate how this technology performs as a non-invasive test to stage liver     fibrosis in patients with chronic liver disease.   "
84389|NCT02181439|"     It is a single-center, prospective clinical study of a medical device, controlled,     randomized, non-stratified, double-blind (neither the patient nor the parents know which area     is irradiated / practitioner who performs the measures and evaluates the class I achievement     or non also ignores the irradiated area) .      Children included in this clinical trial will be their own control, an area receiving LASER     irradiation the other receiving a simulation LASER irradiation (placebo side, inactive laser)     .      In the maxilla, it will be segmented using a technique by the introduction of sectional side     (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support     for Intermaxillary Strength II (or Intermaxillary Elastics II).      The patient should put his own Intermaxillary Elastics II, force adapted to the amount of     class II dental, and this 24h/24. The patient should position him/herself these     intermaxillary elastics in the first mandibular molar to the maxillary canine ; their action,     in case of maximum mandibular anchorage, is to reduce maxillary canine in order to obtain     reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar anchor     is to place the roots of mandibular molars in the vestibular cortex in order to anchor them     there. This allows the lower canines, premolars and maxillary molars under the action of FIM     without causing mutual advancement of the mandibular arch.      This procedure does not differ from the usual treatment. The application of laser diode     appears, by biomodulatrice action, to show promising results on accelerating the kinetics of     tooth movement during orthodontic treatment. The main hypothesis of the research is an     increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest delay     in obtaining the class I for irradiated areas vs. non irradiated ones.      The main objective of this study is to evaluate the effect of the application of low energy     laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II     (Class II elastics)   "
84392|NCT02181400|"     This pilot study aims to establish that treatment with near infrared light (NIR) reduces     diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive     beneficial effect at retinal cellular level.      Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of     blindness in individuals between the ages of 20 and 65 years in developed countries.Swelling     of the central retina or macular oedema. Patients will be treated in an office clinic,three     times a week for a treatment duration of 2 minutes per session, a total of 12 times over the     duration of 4 weeks and will be assessed at 8 weeks to establish any change induced in     retinal oedema.Safety folllow up will be assessed at 3 and 6 months post treatment.   "
84393|NCT02181387|"     The hypothesis is if administration of acetaminophen during labor will reduce the amount of     neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo     capsules will be administered at the time of neuraxial analgesia placement and then     administered every 6 hours until delivery. Overall consumption of neuraxial pain medication     will be determined.   "
84394|NCT02181374|"     The purpose of this study is to evaluate the diagnostic value of serum NT - proBNP in stroke     associated with nonvalvular atrial fibrilltion.   "
84395|NCT02181361|"     The Secondary Prevention of patients with an initial cardioembolic stroke associated with     nonvalvular atrial fibrillation.   "
84396|NCT02181348|"     Anemia is one of the major health problems of the developing countries of the world [1].     According to the WHO reference criteria, an adult is labeled as anemic, if the blood     hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the     non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a     common laboratory finding in apparently healthy people in general population all over the     world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to     establish the probable cause of their anemia and thus may end up with morbidity and health     problems, especially the young women in developing countries [4].      Only few studies on the use of vitamin E in the correction of anemia have been published and     hardly any on correction of mild anemia in healthy adults. The objective of this intervention     study was to investigate the association of vitamin E supplementation with post-supplemental     blood hemoglobin levels in mildly anemic healthy Pakistani adults.   "
84397|NCT02181335|"     To establish that at least one of the two doses of Budesonide, as an ethanolic solution     inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period     in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is     not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200     mcg, 2 puffs bid) and that the safety profile is at least as good   "
84398|NCT02181322|"     Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.     administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality     over a dosage range of 7.5 mg to 22.5 mg   "
84399|NCT02181309|"     Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to     assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.     administration of 22.5 mg meloxicam oral suspension.   "
84400|NCT02181296|"     The objective of our study is to compare the degree of phrenic nerve blockade after     interscalene block using 0.1% ropivacaine or 0.2% ropivacaine. Our hypothesis is that using a     lower concentration of local anesthetic will result in lesser degree of phrenic nerve block.     40 patients will be enrolled. Half will receive the block with 0.1% ropivacaine and half with     0.2% ropivacaine. Phrenic nerve and diaphragm function will be assessed by bedside spirometry     and ultrasound visualization.   "
84401|NCT02181283|"     National Guard members, especially those who have been combat-deployed, are at high risk for     developing alcohol- and prescription-related drug problems. The use of novel Web-based     interventions combined with either Web-based boosters or Peer support sessions, may have a     major public health impact for the National Guard by reducing hazardous use of alcohol of     prescription drugs. The aims of the study are to develop, refine and test tailored     motivational Brief Interventions (BIs) with varied continuing booster reinforcements (Web vs.     Peer) and to conduct a randomized controlled trial comparing the efficacy of these BIs (W+W;     W+P) to usual care on subsequent alcohol/drug consumption and consequences, including injury,     mental and physical-health functioning, and HIV risk behaviors at 4-, 8-, and 12-months     post-enrollment.   "
84402|NCT02181270|"     Individuals with obesity and particular type 2 diabetes have abnormally high levels of fat in     liver cells and are at increased risk for cardiovascular and liver-related mortality. Prior     research has shown that caloric restriction, exercise, and behavior modification can help     lower hepatic fat levels in these individuals. Additional research has also shown that     exercise independent of weight loss can reduce hepatic fat content in obese humans. The     current exercise guidelines do not specify what type or what intensity of exercise is     required to induce such reductions in hepatic fat. Thus, the purpose for doing this study is     to determine if there are differential effects on liver fat with 4 wk of high intensity     intermittent exercise compared with continuous moderate exercise in obese individuals.   "
84410|NCT02181166|"     Myofascial pain considerably affects women undergoing treatment for breast cancer, is     characterized by the presence of myofascial taut bands and trigger points. This study aims to     evaluate the effects of ischemic compression, high-voltage electrical stimulation and     rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer.     This is a randomized blind controlled study. For this, we invited 60 volunteers undergoing     treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia),     G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation     cinesioterapia +). The stance, the plantar pressure distribution and the balance will be     assessed by means of photogrammetry and baropodometry respectively. Myofascial trigger points     will be assessed with the use of infrared thermography, algometry and numerical rating scale     of pain (END). Moreover, the quality of life of the volunteers will be assessed by the     Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The volunteers will undergo 10     sessions of treatment, and reassessed at the end of treatment and after thirty days.     Normality test is used to verify data distribution and consistent statistical test for proper     intra and comparisons between groups, being thus considered two factors in the comparisons,     time and group. A significance level of 5% is assumed.   "
84403|NCT02181257|"     The purpose of this study is to determine if Extracorporeal Photopheresis (ECP) is effective     in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after     lung transplantation. Lung transplantation has become the treatment of choice for selected     patients with end-stage lung disease. However, long-term survival after transplantation     remains disappointing. Chronic rejection (bronchiolitis obliterans syndrome [BOS]) has     emerged as the leading obstacle to better long-term outcomes, and represents the leading     cause of death beyond the first year after transplantation. BOS is diagnosed by the decline     in the FEV1 measurement from a pulmonary function test. The management of BOS has been     disappointing. In general, BOS is treated by intensifying the immunosuppressive regimen.     Despite treatment, most patients continue to show progressive decline in lung function     resulting in worsening functional status, quality of life, and ultimately graft failure and     death.      Extracorporeal Photopheresis (ECP) has been used as a salvage treatment for progressive BOS     with favorable clinical results in many cases showing patient improvement. On May 2, 2012,     the Center for Medicare Services issued a decision memo statin the ECP is covered for     Medicare beneficiaries for the treatment of BOS following lung allograft transplantation only     wehn the procedure is provided under a clinical research study. It is highly unlikely that     providers that currently order ECP for their BOS patients who have already failed optimized     immunosuppressive drug therapy would be willing to randomize half of their patients to     continue on their failed drug therapy.What is not well understood at this time, however, is     whether certain coexisting disease states or patient-related demographic, functional,     treatment-related or diagnostic variables might prove to have predictive value in identifying     subsets of BOS patients that are likely, or unlikely, to experience reduced rate of decline     or stabilization in FEV1 following ECP treatment. This is a Registry study to enroll 160     patients from multiple U.S. centers to (1) confirm that ECP significantly reduces the rate of     FEV1 decline in BOS patients refractory to standard immunosuppressive drug therapy, and (2)     capture and assess specified patient demographic, treatment-related, diagnostic, functional     and co-morbidity- related variables that may predict outcomes after ECP therapy.   "
84404|NCT02181244|"     There is concern in the literature regarding egg consumption in diabetic people. The     investigators hypothesis is that compared to an oatmeal-based breakfast, an egg-based     breakfast will not increase the risk for heart disease in diabetic people but it may reduce     inflammation, in this population characterized by chronic low grade inflammation.      This is a cross-over study in which subjects will be randomly allocated to consume 1 egg per     day for breakfast or a bowl of oatmeal with lactose-free milk for 5 weeks. After a 3 wk     washout period, subjects will be allocated to the alternate treatment for additional 5 weeks.      Blood will be collected at baseline and at the end of each dietary period to measure plasma     lipids, glucose, insulin, glycosylated hemoglobin and inflammatory markers.   "
84405|NCT02181231|"     The investigators are conducting a research study to learn about the safety and benefit of     using a medication called buprenorphine for patients with difficult to treat depression. This     research study is testing whether combining two medications will be effective in treating     depression when initial treatment with just one antidepressant does not relieve the     depressive symptoms; this is what is called difficult to treat depression or treatment     resistant depression. The two medications the investigators are using are: an     anti-depressant medication called venlafaxine extended release (venlafaxine XR), which is the     generic form of Effexor, and buprenorphine. Buprenorphine is a medication that is FDA     approved for the treatment of opioid dependence. The investigators are testing whether adding     buprenorphine to venlafaxine XR enhances treatment response.   "
84406|NCT02181218|"     The purpose of this research study is to find the maximum tolerated dose of a drug called     romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment     for certain types of lymphoma, and involves the administration of three drugs: gemcitabine,     oxaliplatin, and dexamethasone. In addition to finding the maximum tolerated dose of     romidepsin, the investigators want to look at the side effects of these drugs when given     together, as well as how the lymphoma responds to this treatment.   "
84407|NCT02181205|"     The investigators are attempting to determine a less invasive method of treatment for     postdural puncture headaches that can occur after regional anesthesia. The investigators will     be evaluating the relief of headache with those subjects receiving treatment with a     sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of     epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with     post study treatment versus placebo, and potential side effects of those patients receiving     study therapy as well as epidural blood patch.   "
84427|NCT02180945|"     The objective of this study is to evaluate the safety (at 1 month) and the performance (at     3-6 months) post last embolization with Onyx or Onyx associated with other embolization     products (cyanoacrylate glue, coils, balloon, other…)   "
84470|NCT02180373|"     The overall goal of this multicenter collaborative research study is to identify genetic,     proteomic, and/or lipidic (lipidomic) biomarkers associated with the outcomes of lower     extremity revascularization in patients with advanced peripheral artery disease (PAD).   "
84408|NCT02181192|"     PSA-recurrence prostate carcinoma is associated with two general problems.        1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local,          locoregional oder systemic relapse is available.        2. There is no standard therapy proved by randomised clinical trials. Recommended          radiotherapy starting with PSA-value < 0.5 ng/ml according to german S3 guidelines is          based on retrospective data.      These difficulties may lead to a therapy potentially not adapted to patients situation of     disease.This study aims to randomised examine if an instant radiotherapy of prostate     PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional     imaging (PSA value >= 1 ng/ml) including PET/CT and bone scintigraphy for reliable     information about tumor location and expansion is beneficial regarding therapy efficiency,     quality of life and social economic aspects.   "
84409|NCT02181179|"     The primary aim of this research study is to examine the effects of an 8-week yoga program on     aspects related to nicotine dependence, stress, and coping during a smoking quit attempt.      Guided by initial studies reporting on the effects of yoga on putative mediators of smoking     relapse (i.e., cortisol, distress intolerance, withdrawal symptoms), the proposed experiment     examines the effects of an 8-week yoga practice on nicotine withdrawal intensity by way of     aiding withdrawal characteristics predictive of smoking relapse. The long-term objectives of     the proposed line of research are to: (1) inform theoretical models of nicotine withdrawal,     (2) guide the development of effective alternative interventions for smokers susceptible to     relapse during the critical withdrawal period (i.e., smokers low in distress tolerance), and     (3) to help guide behavioral strategies for treating substance addictions broadly.   "
84431|NCT02180893|"     Pain after robotic cardiac surgery is a known problem and is often difficult to manage.     Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A     paravertebral block has been shown to provide good pain relief with minimal side effects,     however, paravertebral blocks for robotic surgery have not been well studied. Currently the     investigators routinely perform PVB on this patient population (of 50 MV robotic cases done     between January and October 2012, 36 received paravertebral blocks with no adverse events     noted). The investigators believe this should be studied further and that paravertebral     blocks will reduce the amount of additional pain medication patients require in the first 24     hours after surgery, decrease intubation time and improve PACU and hospital discharge times.   "
84411|NCT02181153|"     Although the precise etiology of inflammatory bowel disease (IBD) is still unknown, over the     last decade active research allowed to gain more precise insights in the pathophysiology of     IBD indicating that the chronic inflammation of the intestinal mucosa is directed against the     microbiota of the gut in particularly susceptible individuals. Genetic studies and more     recently genome-wide association studies (GWAS) have allowed to identify over 70     susceptibility genes which confer an increased risk of developing IBD. In the last years the     attention of researchers has shifted to the identification of the early immunological changes     that occur already at a preclinical stage of the disease, trying also at identifying the     disease before it shows itself. Recently, the ability of a combination of serological markers     in predicting the development of IBD has been demonstrated in adults. However, there are no     studies evaluating a cohort of children at high risk for the disease, in whom the first     immunological changes underlying the development of IBD could be studied, including a     combination of genetic, serological, fecal and clinical markers.      The purpose of this study is to evaluate in a population genetically well-characterized, as     siblings and twins of patients affected with IBD, early genetic, serologic, fecal and     clinical markers of disease, which may be present even years before developing the disease.     The identification of these markers in predisposed individuals could help to implement     strategies for prevention or early treatment to modify the natural history of IBD.   "
84412|NCT02181140|"     The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic     ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS     aspiration needle in GI-tumors.   "
84413|NCT02181127|"     This study will test the hypothesis that a wearable automated bionic pancreas system that     automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for     people with type 1 diabetes > 21 years old.   "
84414|NCT02181114|"     Because of the deceased donor organ shortage, more kidney patients are considering whether to     receive kidneys from family and friends, a process called living donor kidney transplantation     (LDKT). Although Blacks are 3.4 times more likely to develop end stage renal disease, they     are less likely to receive LDKTs. To address this disparity, this randomized controlled trial     will assess whether Black and White transplant patients' knowledge and receipt of LDKTs can     be increased when they receive access to the Your Path to Transplant computerized Expert     System (YPT). This trial will also examine how other known patient, family, and healthcare     system barriers to LDKT impact YPT's effectiveness.      Nine hundred (900) Black,White and Hispanic ESRD patients presenting for transplant medical     evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program     (UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to     one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant     evaluation, patients in the YPT condition will receive individually-tailored feedback     reports, coaching, and socioeconomic resource guidance associated with reducing barriers to     access to LDKT. Control patients will receive usual care transplant education provided by     UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and     self-efficacy will be assessed at four time points: prior to presenting at the transplant     center (baseline), during transplant evaluation (approximately 2 months post-baseline), and     4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will     be assessed 18-months post-baseline.      At the conclusion of the study, we will have developed an innovative and cost-effective YPT     Computerized Expert System that could be utilized to tailor LDKT discussion and education in     different medical settings based on the needs of individual patients of different races.   "
84415|NCT02181101|"     This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III     study comparing the disease free survival after randomisation in patients treated with 3     cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of     Docetaxel(Doc)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC),     followed by 3 cycles of Gemcitabine-Docetaxel(DocGemzar)-chemotherapy, and to compare the     disease free survival after randomisation in patients treated with 2 years of Zoledronate     versus 5 years of Zoledronate in patients with early primary breast cancer. Patients will be     required to have histopathological proof of axillary lymph node metastases (pN1-3) or high     risk node negative, defined as: 'pT≥2 or histopathological grade 3, or age ≤ 35 or negative     hormone receptor', but are not allowed to have evidence of distant disease. Patients will     have to be entered into the study no later than 6 weeks after complete resection of the     primary tumor. No other antineoplastic treatment other than surgical treatment, the defined     cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and     during the course of the study.      After surgery, leading to R0 resection of the invasive and intraductal components of the     primary tumor, patients will be randomized to one of the following treatments:      First randomization      AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v.     and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day     22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (Doc), and     Gemcitabine 1000 mg/m² i.v. (30 min infusion) (Gemzar), administered on day 1, followed by     Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22      AB: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v.     and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day     22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (Doc),     administered on day 1, repeated on day 22      Second randomization B      BA: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently     followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three     years      BB: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years      During the zoledronic acid treatment period, patients will receive 500 mg Calcium p.o. qid     and 400 i.E. Vitamin D p.o. qid.      Patients with positive hormone receptor status (≥ 10 % positively stained cells for estrogen     and/or progesterone) of the primary tumor will receive Tamoxifen treatment 20 mg p.o. per day     for 2 years, after the end of chemotherapy. Subsequent to chemotherapy, postmenopausal     patients with positive hormone receptor status will be treated with Anastrozole (Arimidex®) 1     mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment for     additional 3 years. In addition to tamoxifen, all patients with positive hormone receptor     status of the primary tumor and under the age of 40 or restart of menstrual bleeding within 6     months after the completion of cytostatic treatment or with premenopausal hormone levels as     defined below will receive Goserelin (Zoladex®) 3.6 mg subcutaneously every 4 weeks over a     period of 2 years following chemotherapy. Premenopausal endocrine status will be assumed, if     the following serum levels are met: Luteinizing hormone (LH) < 20 mIE/ml, follicle     stimulating hormone (FSH) < 20 mIE/ml and estradiol (E2) > 20 pg/ml. Endocrine therapy will     start after the end of chemotherapy.      All patients with breast conserving therapy or more than 3 axillary lymph node metastases or     in the following cases after mastectomy:        -  T3/T4-carcinoma        -  T2-carcinoma > 3 cm        -  multicentric tumor growth        -  lymphangiosis carcinomatosa or vessel involvement        -  involvement of the pectoralis fascia or a safety margin < 5 mm.      will receive adjuvant radiotherapy.   "
84416|NCT02181088|"     The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at     different doses and alone or in combination. The study will enable us to assess the safety of     the vaccines and the extent of the immune response in healthy volunteers. We will do this by     giving volunteers one or two vaccinations, doing blood tests and collecting information about     any symptoms that occur after vaccination. This is the first trial to use these vaccines in     humans.   "
84417|NCT02181075|"     This proof of concept study proposes targeted delivery of a broad-spectrum cytotoxic agent     (doxorubicin), via a specially formulated LTSL (ThermoDox®) activated by mild hyperthermia,     by using focused ultrasound (FUS), to achieve enhanced intra-tumoural doxorubicin     concentrations for the same systemic dose.   "
84441|NCT02180763|"     The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment     interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL     according to the delivery device.   "
84418|NCT02181062|"     Stroke is a cruel disease that disproportionately kills and disables African-Americans,     Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at     particularly high risk. There is a higher incidence of hemorrhagic stroke in African     Americans, Latinos, and Chinese Americans relative to non-Latino whites. Asian-Americans have     up to 1.4 higher relative risk of stroke death compared to U.S. non-Latino whites. A critical     need therefore exists for a sustainable and scalable mechanism to disseminate     culturally-tailored stroke knowledge/prevention education in community-based settings where     large numbers of these high-risk ethnic minority older adult groups are regularly served,     such as in federally funded Multipurpose Senior Centers (MPCs) that exist across the nation     (16 of which are in Los Angeles alone).      The overall objective of the proposed study is to develop and test the implementation of a     training program for case managers at senior centers to implement a stoke     knowledge/prevention education program among four high-risk ethnic minority older adult     groups--Korean-American, Chinese-American, African-American, Latinos. We propose to develop a     culturally-tailored case manager training curriculum, implement the training at 4     community-based sites, and evaluate the training model using a randomized wait-list     controlled trial (n=244) testing the hypothesis that training case managers will decrease     older adult participants' stroke risk in a sustainable fashion through increasing their     preventative behavior (i.e. increasing their physical activity--mean steps/day--at 1 and 3     months).      Findings will inform similar community-academic partnership efforts around stroke and other     disease-specific prevention research/interventions; they will also determine next steps in     terms of whether this case manager-centric model can be scaled up and deployed in other     community-based settings.   "
84419|NCT02181049|"     Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to     over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from     significant excess in mortality risk associated with treatment-related complications at least     for 25 years after the initial cancer diagnosis. In particular, the prevalence of     cardiovascular disease seems to be elevated compared to the general population. The CVSS     study is a multi-disciplinary cooperation project between the Institute for Medical     Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry     (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and     Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz. The     central element is a thorough clinical cardiovascular examination of all patients, which     permits detecting subclinical disease. Therapy data will be extracted retrospectively from     various sources. The study intends to describe the current situation of a cohort of     approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health.     The role of risk factors (treatment related and classic cardiovascular risk factors), as well     as related predisposing genetic factors is investigated. The results will contribute to     recommendations to improve follow-up care.   "
84420|NCT02181036|"     To identify the effects of family work shop for children with speech developmental delays.   "
92872|NCT02070471|"     Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126     immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI     (ST-segment Elevation Myocardial Infarction)   "
84421|NCT02181023|"     -  Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and          flow limitation. These physiopathological modifications are secondary to loss of elastic          recoil and bronchial obstruction due to emphysema.        -  The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and          anticholinergics. The molecules of the latter classes can be characterized by short          lasting action (few hours), long acting action (12 hours) or ultra long acting duration          of action (24 hours).        -  For years the only anticholinergic (or antimuscarinic) drug other than those used by          aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been          launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice          daily).        -  The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume.          The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase          III        -  For COPD patients, the most important characteristic for an inhalatory drug is a prompt          action in order to give a quick relief from respiratory symptoms, in particular          dyspnoea.        -  The objective of this study is to study the acute action of glycopyrronium and          aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung          volume distribution and dyspnoea at rest in severe COPD patients.        -  To our knowledge no study has explored these aspects before.   "
84422|NCT02181010|"     The BHCK study will develop, implement, and evaluate a community-based obesity prevention     program, which operates at multiple levels of an urban food system (policy, wholesaler,     corner stores, carryout, household, individual; in Baltimore, MD), and will improve the     healthy food supply chain to increase affordability, availability, purchasing and consumption     of healthy foods within low-income, minority neighborhoods.   "
84423|NCT02180997|"     The purpose of this study is to investigate the pharmacokinetic drug interaction between     Solifenacin and Tamsulosin in healthy male volunteers.   "
84424|NCT02180984|"     The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating     disorder (BED) is a new category in DSM-5 highly associated with higher body mass index     (BMI). The neural mechanisms that underlie BE are of great interest in order to improve     treatment interventions. Brain mechanisms underlying drug and food craving are suggested to     be similar. These mechanisms demonstrated hyperactivity in the orbitofrontal and anterior     cingulate cortex and lack of regulatory influence from lateral prefrontal circuits. Several     novel studies began to assess the potential benefits of brain stimulation in reducing craving     and associated addictive behaviors with promising results. Previous findings testing a     one-off session of repetitive transcranial magnetic stimulation (rTMS) in healthy women     identified as strong cravers and individuals with bulimia nervosa or bulimic-type eating     disorders reported reduction of food craving and BE, providing evidence to support a broader     and deeper investigation of the benefits associated with rTMS. Importantly, the use of brain     imaging studies contributes to the understanding of psychiatric disorders and underlying     mechanisms being target by the rTMS intervention.      Objectives: The primary aim is to investigate the effects of rTMS over BE frequency.     Secondary aims include the evaluation of the effects of rTMS on food craving, body weight,     brain activity, cognition, general psychopathology, hormonal regulation and neurobiological     markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of     rTMS (n=30) or placebo (n=30) scattered 3 days/week.      Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency.     Consequently, body weight will be reduced. It is also expected that food craving be     decreased, cognitive performance be enhanced, and neurobiological markers be improved.   "
84425|NCT02180971|"     The purpose of this study is to compare the extent of coronary vessel stenosis between     coronary spasm-induced angina attacks (named vasospastic angina, VSA) patients and health     volunteers by multi-detector computed tomography angiography (MDCTA), and to evaluate the     diagnostic efficacy of MDCTA in patients with VSA.   "
84426|NCT02180958|"     The main objective of this study is to assess the safety at 1 month after any embolization     session and the efficacy at:        -  12 months post last embolization in case of treatment with embolization only        -  12 months after additional treatment with neurosurgery        -  36 months after additional treatment with radiosurgery   "
84428|NCT02180932|"     The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used     in combination with chemotherapy. Patients treated with radiotherapy have multiple oral     diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70%     of patients with head and neck cancers treated with radiotherapy have a lower level of dental     clinical attachment and 92% have loose teeth or missing. The management of these oral     complications is a priority in OLR oncology. The aim is to improve the oral health of     patients to achieve a comfortable life acceptable and necessary for healing.      This project proposes to deepen the investigation with two main objectives:        1. To study in vivo the effect of radiation treatment on the evolution of the viral flora          of the periodontium in a cohort of patients and matched controls.        2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in          producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated          with EBV that existence were recently discovered.   "
84429|NCT02180919|"     The aims of the study are to:        1. Implement a telemonitoring programme in heart failure and obstructive pulmonary disease          (COPD) /chronic respiratory patients by assessing the real world impact of on          readmissions, consults, home visits, quality of life and economic endpoints.        2. Explore the effects of telemonitoring across heart and respiratory groups with respect          to i) factors that influence how patients integrate telemonitoring into their daily          routines and self care behaviour and ii) how healthcare professionals use telemonitoring          to aid decision- making.        3. Understand the impact of telemonitoring on a variety of care pathways.   "
84430|NCT02180906|"     The purpose of this study is to investigate the immune response in patients with necrotizing     soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive     biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and     the following 3 days   "
84432|NCT02180880|"     1. Neuropathic pain in spinal cord injured patients        1. Inclusion criteria             -  pain intensity, visual analogue scale > 3             -  a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above             -  aged ≥20        2. Method             -  Stop pain medications             -  Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)             -  Check pain intensity (VAS score) with Baron's classification   "
92892|NCT02070211|"     The purpose of the present trial is to investigate the effects of omega-3 PUFAs in     individuals aged 12-26 years with 22q11DS at ultra-high risk for developing a first episode     of psychosis.   "
84433|NCT02180867|"     This randomized phase II/III trial studies how well pazopanib hydrochloride, combination     chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in     combination with pazopanib hydrochloride or combination chemotherapy in treating patients     with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by     surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as ifosfamide and doxorubicin hydrochloride, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     radiation therapy works better when given with or without combination chemotherapy and/or     pazopanib hydrochloride in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.   "
84434|NCT02180854|"     Acute deterioration among hospitalised patient can result in serious adverse events like     cardiac arrest, unexpected death or unanticipated intensive care unit (ICU) admission. Most     events are preceeded by deteriorating vital signs, and potentially avoidable.      To detect and treat hospitalised at-risk patients early an early warning score (EWS) was     introduced at the investigator site. EWS measures of a number of physiological parameters     that are aggregated to a common score, that directs monitoring frequency, clinical     interventions and competency of the provider.      Patients with low scores (0 - 1) are monitored every 12th hour and seldom experience serious     adverse events. The optimal monitoring frequency for this group is unknown, and presently     based on a compromise between patient safety and work load issues.      The aim of the present study is to explore if an 8 hourly monitoring interval (intervention)     is correlated with a better outcome than 12 hour intervals (control), based on the number of     patients that deteriorate to a higher EWS 24 hours after hospital admission in each group.   "
84435|NCT02180841|"     The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate     with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle     size and HDL function), central blood pressure, and indices of arterial stiffness.   "
84436|NCT02180828|"     The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs     Fluconazole for the treatment of severe vulvovaginal candidiasis   "
84437|NCT02180815|"     The purpose of this post-market observational study is to assess the effectiveness and     patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with     Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is     a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep     Apnea System consists of an implanter kit and tongue implants. The implants are permanently     implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent     tongue base closure during sleep.   "
84438|NCT02180802|"     Motivational interviewing (MI) has been shown to be an effective strategy in targeting     obesity in adolescents and parental involvement has been associated with increased     effectiveness. The aim of the study is to evaluate and compare the role of parental     involvement in MI interventions for obese adolescents   "
84439|NCT02180789|"     This is an open-label, single-arm, prospective interventional study to assess the     tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied     with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated     with benign prostatic hyperplasia (BPH).   "
84440|NCT02180776|"     The objective of this study is to evaluate clinical effectiveness and the effect on quality     of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic     patients with moderate to severe back pain disability and to demonstrate the safety of the     intervention through detailed reporting and analysis of adverse events.   "
84442|NCT02180750|"     Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children     living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the     intervention improves outcomes compared to standard care. We aim to test the hypothesis that     attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural     difficulties, and self-efficacy compared to standard care.   "
84443|NCT02180737|"     Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing     interventional radiological procedures and measuring its different outcome variables.   "
84444|NCT02180724|"     This study is evaluating the safety and efficacy of acalabrutinib for the treatment of     subjects with Waldenström Macroglobulinemia (WM)   "
84445|NCT02180711|"     To characterize the safety profile of acalabrutinib alone or in combination with rituximab in     subjects with relapsed,refractory,or treatment naive Follicular Lymphoma (FL)   "
84446|NCT02180698|"     This pilot phase I clinical trial studies the side effects and best dose of toll-like     receptor 4 (TLR4) agonist glucopyranosyl lipid A (GLA)-stable-emulsion (SE) when given     together with radiation therapy in treating patients with soft tissue sarcoma that has spread     to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). TLR4     agonist GLA-SE may stimulate the immune system to kill sarcoma cells. Radiation therapy uses     high energy x rays to kill tumor cells. Giving TLR4 agonist GLA-SE with radiation therapy may     be a better treatment to treat sarcoma that cannot be removed by surgery.   "
84447|NCT02180685|"     The purpose of this present study is to determine which surgery technic provides the best     clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors     and screw fixation in medial femoral condyle.   "
84448|NCT02180672|"     This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids     for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy,     duration of action and side-effects will be determined.   "
84449|NCT02180659|"     The primary objective of the study is to demonstrate maintenance of treatment efficacy when     transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg     or less of sublingual (SL) buprenorphine (BPN), to 4 Probuphine implants compared to SL BPN.      The secondary objective of the study is to confirm safety of 4 Probuphine implants in adult     outpatients with opioid dependence who are clinically stabilized on 8 mg or less of SL BPN.   "
84451|NCT02180633|"     A macular hole is a rupture in the macula. In terms of pathogenesis, as much as 80% are     idiopathic (Idiopathic Macular Hole, IMH). The normal incidence of this condition is about     0.17%; however, there is a 10-29% chance of development of a macular hole in the fellow eye     of patients suffering from unilateral macular hole.      Our hypothesis is that embedded in the topography of the retina is information that can allow     for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As     such, our work aims to develop a system that allows the automatic identification of these     eyes.   "
84452|NCT02180620|"     With many medications we prescribe them relative to time of day or a meal. This study     established if pre dinner vs post dinner exercise was more effective at altering post dinner     glucose and triglyceride levels vs no exercise at all.   "
84453|NCT02180607|"     The overall goal of the proposed project is to investigate the neuronal pathways regulating     the effects of social acceptance and rejection in healthy controls and patients with Major     Depressive Disorder (MDD). Social acceptance and rejection are defined as the explicit     declaration that an individual is liked or not liked. Social acceptance can boost one's     self-esteem and mood, whereas rejection can lower them. The neurological relationship between     social acceptance/rejection and depressive symptoms is not known. Using functional magnetic     resonance imaging (fMRI), it is hypothesized that social feedback will activate a specific     interconnected neuronal pathway involved in social separation and reward. Executive     functioning and response to monetary reward will also be assessed during fMRI using two     additional tasks (monetary incentive delay, parametric go no-go) to determine how these     cognitive brain functions regulate responses to social feedback.   "
84454|NCT02180581|"     The aim of the intervention is to examine the effect of a combination of the two bacterial     strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic     manifestations in small children, and how a combination of BB-12 and LGG affects the immune     system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter     seasons.   "
84455|NCT02180568|"     The study object is to demonstrate the usefulness and safety of lipiodol localization     technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic     surgery (VATS) resection compared to hook wire localization technique. A total of 250     participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims     of this study are achieved, the use of lipiodol localization technique will be widespread     their application for localization of non-palpable pulmonary lesions that are indicated for     VATS resection.   "
84456|NCT02180555|"     Stress hyperglycaemia is commonly observed during hospitalization in the intensive care unit     (ICU) and has been shown to adversely influence outcome. It has been hypothesized that, when     it occurs in previously non-diabetic patients, it reflects a latent disturbance of the     glucose metabolism. Assessing the incidence of this phenomenon and identifying its risk     factors could support prevention, detection and early treatment of impending diabetes     mellitus type 2. We will perform a glucose tolerance test approximately 6-9 months post-ICU     admission to screen for disorders of glucose metabolism. Furthermore, we examined     characteristics that could have predicted the post-discharge disturbances: patient     characteristics, parameters of disease severity and of glucose metabolism, as well as the     FINDRISC (Finnish Diabetes Risc Score). We plan to enroll 400 patients.   "
84457|NCT02180542|"     The purpose of this study is to improve secondary prevention of ischemic stroke patients by        1. Estimating prevalence and the prognostic significance of frequent premature atrial          complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial          fibrillation.        2. Characterize ischemic stroke patients by             1. Echocardiographic characteristics             2. Biochemical markers             3. Plaque composition in the carotid arteries                  -  in order to improve risk stratification.   "
84458|NCT02180529|"     Background: The increase in life expectancy and the rise in the ratio of older to younger     people in the population has resulted in an increase in the number of those suffering from a     decrease in cognitive ability, such as Mild Cognitive Impairment (MCI). Methylphenidate can     improve cognitive ability, mainly in memory and executive function.      Working hypothesis and aims:      This study examines the effect of Ritalin treatment in older people suffering from MCI. Our     hypothesis is that treatment with Ritalin will improve cognitive function in those suffering     from MCI, especially in the domains of attention and executive function.      Methods A randomized, double-blind, case-control study. 120 patients older than 65 years of     age diagnosed as suffering from MCI in the past year in geriatric assessment facilities in     Beersheva. Patients will be randomized in equal groups to either the study group (Ritalin     treatment) and control group (placebo). Each participant will attend the geriatric unit for     four consecutive days: on the day prior to beginning the intervention participants will     undergo cognitive assessment at 9:00 am. On the intervention days (days 2-4) participants     will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at     10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention.     Participants in the control group will receive placebo. Two hours after taking the drug or     placebo participants in both groups will be assessed cognitively by means of Mindstreams and     MoCA (Montreal Cognitive Assessment).      Expected results: Ritalin treatment will improve the cognitive function of the subjects,     mainly in the domains of concentration and executive function   "
84459|NCT02180516|"     Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal     adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.   "
84460|NCT02180503|"     Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB     reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a     food effect for the 10 mg tablet dose group   "
84461|NCT02180490|"     Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules     (reference drug) of meloxicam (UHAC 62 XX) in fasted state.   "
84462|NCT02180477|"     Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different     tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent     pivotal bioequivalence (BE) study between capsule and tablet formulations.   "
84463|NCT02180464|"     Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a     LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation     (PoC).   "
84465|NCT02180438|"     There is a critical need for safe and effective antiretroviral treatment (ART) regimens for     HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2     million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is     limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors     (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance     to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in     HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be     used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their     susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and     darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is     frequent. Although an increasing body of evidence supports the potential utility of integrase     inhibitors (INI) against HIV-2, there have been no clinical trials to assess their     effectiveness and they are not routinely available in resource-limited settings. These     limitations present major challenges to HIV-2 treatment, particularly in the areas in which     it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat     (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet     regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will     be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1:     A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine,     tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM     2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals     with virologic failure (HIV-2 plasma RNA >250 copies/ml) participating in the 48 week trial     of STRIBILD   "
84466|NCT02180425|"     The purpose of this study is to evaluate the differences in the skin lipid profile of     patients with and without acne. Secondly, the goal is to learn more about what the effects of     retinoinds (topical and systemic) are on the the skin lipid profile. We hypothesize that the     skin lipid profile of subjects with acne will be lower in inflammatory lipids in comparison     to subjects without acne.   "
84467|NCT02180412|"     This study aims to provide high quality evidence for the effectiveness and safety of hemin     (PanhematinTM , Recordati) for treatment of acute attacks of porphyria. These types of     studies have not been done before with either PanhematinTM or the hemin preparation available     in Europe (NormosangTM, Orphan Europe).      There are two treatment groups in this study. One group will be treated with PanhematinTM     plus glucose, and the other group will be treated with glucose plus an inactive salt solution     (called a placebo). To avoid prejudice, the treatment given to each participant will be     blinded (meaning the participants and most of the hospital staff will not know which     treatment the participant will receive) and randomized (meaning participants will have an     equal chance of receiving either treatment, like the flip of a coin). A placebo-controlled,     randomized study is the standard method used to prove treatments are effective and safe.     PanhematinTM and glucose will be given in the same manner as is usual for treating an attack     of porphyria. For participants who are chosen to receive the placebo, their treatment will be     switched to real PanhematinTM at any time if their symptoms do not improve. This is called     rescue treatment, and assures that they study is safe and patients who need hemin will     receive it. Treatment with hemin will be for 4 days, or longer if needed. Since the study     treatment is started as soon as possible after symptoms appear, there will be very little     delay in providing hemin to those who need it. Funding Source - Office of Orphan Products     Development (FDA OOPD)   "
84468|NCT02180399|"     Determination of capillary lactate by using point-of-care technique is accessible, fast and     allows to quantify the circulatory and metabolic dysfunction caused by sepsis. Compared to     conventional assay techniques in arterial blood, capillary assay technique may have an     increased susceptibility to metabolic alterations induced by sepsis in its initial stages.     This increased sensitivity is not necessarily relevant in the management of the most serious     patients for whom the diagnosis is obvious, but it could be very useful in patients for whom     a diagnosis of severe sepsis or shock have not yet been adopted, particularly to help better     identify patients who would require intensive management and avoid the installation of these     serious disorders.   "
84469|NCT02180386|"     The aim of the study was to assess whether the behavior, anxiety, and dental pain of     pediatric patients during dental treatment improves when a video game is played as method of     distraction.   "
84471|NCT02180360|"     Background: Nowadays, a commonly used sport that helps enhancing physical fitness components,     including flexibility, is Capoeira. This modality is defined as an athletic sport composed by     an individual attack and defensive system, which was originally created in colonial Brazil.     Capoeira is characterized by its main movement, the ginga, and by other several dodging,     unbalancing, traumatizing and acrobatic movements. The literature empirically discusses that     Capoeira contributes in general physical fitness by modulating several variables of human     movement. Among these variables it is possible to highlight the influence of Capoeira in the     amplitude of movement of the practitioner's joints. However, no study with a control group     has investigated the alterations in flexibility of beginners using an experimental protocol     based exclusively in basic techniques of Capoeira, without applying any usual stretching     exercises that are commonly used, independently of the specificity of the sport. Objective:     To analyze the effects of eight weeks of basic training in Capoeira on the flexibility of     beginners in the sport. Methods: Twenty-one individuals, divided in two groups [Capoeira,     n=13; 26.1±7.2 years; 22.7±2.7 kg.m2(-1) and Control, n=8; 27.1±0.5 years; 24.3±3.3     kg.m2(-1)] participated in the study. The Capoeira group performed eight weeks of basic     training (two sessions per week lasting 60 minutes each). The experimental protocol used was     exclusively based in basic techniques of a programmed Capoeira training system. Before and     after the intervention measurements were performed aiming to analyze: trunk flexion     flexibility, through a sit-and-reach test using a Wells' Bench (WBtf); and passive tension     (PThf) and maximum amplitude of hip flexion (MAhf) through goniometry. The hypothesis of this     study is that the group Capoeira (beginners) will increase the linear and angular flexibility     after eight weeks of basic training in the sport.   "
84472|NCT02180347|"     The objective of this study is to determine if multifocal contact lenses affect accommodation     and/or binocular vision when worn by pediatric patients. This will be accomplished through     subjective and objective accommodative and binocular experiments in children wearing single     vision and multifocal soft contact lenses.   "
84473|NCT02180334|"     The aim of this study is to investigate the effects of combined administration of mosapride     as modulator of gastrointestinal motility and DPP-4 inhibitor on secretion of gut hormone     such as glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP), and oral     glucose tolerance. Additionally, change in lipid profile and insulin secretion will be also     assessed.   "
84611|NCT02178527|"     This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of     a multifaceted podiatry intervention designed to reduce falls in care homes. The     investigators hypothesise that the intervention will reduce the high falls rates present in     care homes for older people, compared to usual care.      The results will inform the sample size calculation for a full-scale definitive RCT   "
84474|NCT02180321|"     Massive bleeding is expected when performing distraction osteotomy for craniosynostosis     patients. Since such operation is performed at very young age, many efforts are performed in     order to reduce the total amount of bleeding and the transfusion during and after the     surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion     during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic     acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the     changes in coagulopathy will be defined using thromboelastography.   "
84475|NCT02180308|"     The overarching goal of this study is to develop PET/MR techniques to accurately detect nodal     metastases for surgical planning and assessment of treatment response.   "
84476|NCT02180295|"     The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety,     tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is     that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days     after the fourth dose.   "
84477|NCT02180282|"     Up to 20 healthy subjects age 15-45 years old ,Skin Phototype I-V,Study will be conducted in     1 site.      Primary objectives is to evaluate the efficacy of IPL acne filter treatment for improvement     of acne vulgaris as assessed by lesion count.   "
84478|NCT02180269|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK,     study of the way a drug enters and leaves the blood and tissues over time) of     single-ascending oral doses of JNJ-54861911 in healthy Japanese male participants.   "
84479|NCT02180256|"     To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler,     performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates     in women who will be submitted to a fresh embryo transfer.   "
84480|NCT02180243|"     The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE)     and iRest Yoga Nidra (meditation)/auricular (ear) acupuncture for Veterans with Gulf War     Veterans' Illnesses (GWVI).   "
84481|NCT02180230|"     The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark     System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate,     soft tissue health and maintenance.   "
84482|NCT02180217|"     The study aims to confirm long-term efficacy and safety of LCI699 for the treatment of     patients with Cushing's disease. It is a pivotal trial intended to support the registration     of LCI699 for the treatment of patients with Cushing's disease in the EU, Japan, and other     countries.   "
84483|NCT02180204|"     This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of     intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present     with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.   "
84484|NCT02180191|"     An altered gut microbiota composition has recently been linked to obesity and diabetes. The     principal aim of this study was to investigate and compare the gut microbiota composition of     obese, diabetic and control individuals. Then, associations between analyzed gut microbial     concentrations and clinical-biochemical blood parameters were assessed.   "
84485|NCT02180178|"     Goal of the registry is to collect data on patients undergoing coronary angiography in Mainz.     Following amendment of the procol, this study will also include patients who received an     Aborb bioresorbable scaffold for the therapy of de novo stenoses.   "
84487|NCT02180152|"     The purpose of this study is to verify if postprandial walks are effective in obese pregnant     women, as regards to gestational weight gain and typical diseases of that period, as     gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as     macrosomia, shoulder dystocia and fetal death.   "
84494|NCT02180061|"     This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of     pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive     pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is     that treatment with single agent pembrolizumab will result in a clinically meaningful overall     response rate.   "
84488|NCT02180139|"     Dystonia is a devastating disorder defined by involuntary, sustained muscle contractions or     abnormal postures that can affect any part of the body. Cervical dystonia (CD) is the most     pervasive form of dystonia affecting 60-90,000 individuals in the United States alone and is     characterized by involuntary twisting of the neck. The symptoms of CD are disabling,     disfiguring, painful, and have a strongly negative impact on quality of life, including     social withdrawal and depression. At present, there is no treatment that has been shown to     have long term benefit in CD. Standard of care (SOC) is botulinum toxin, which temporarily     paralyzes affected muscles, resulting in reduced muscle spasms. This treatment has many     undesirable side effects, variable effectiveness, is expensive, and must be repeated every 3     months throughout the lifespan. Physical therapy based treatments aimed at retraining posture     or stretching dystonic muscles are largely ineffective and not typically delivered as a part     of standard of care. There is an urgent need for novel and effective therapies. Emerging     technologies, specifically non-invasive brain stimulation (NBS), have demonstrated compelling     evidence to make a meaningful impact in the lives of people with CD. In this study,     individuals with cervical dystonia will be randomly assigned to receive tDCS for 15 minutes     daily for 4 days in 1 of 4 stimulation location groups.      Hypothesis 1: One location of stimulation will result in clear benefit with at least 1     standard deviation (SD) improvement in the CDQ-24, the primary outcome measure, at 1-week     follow-up.      Hypothesis 2: The cortical silent period will be the most sensitive measure investigated and     will demonstrate significant increase in inhibition as determined by an elongation of silent     period in the affected upper trapezius muscle.      Hypothesis 3: The stimulation location determined to be most effective in Objective 1 will     produce the greatest physiologic change in inhibition increase.      Hypothesis 4: The hypothesis for this aim is if certain characteristics can predict response     to treatment, a strong association will be seen between baseline measure(s) and the primary     outcome measure. A thorough assessment of characteristics including: age, sex, duration of     symptoms, genotyping for two specific polymorphisms, botulinum toxin history, baseline     measures of outcome variables, measures of brain excitability, and genetic testing will     predict response.   "
84489|NCT02180126|"     A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a     high probability for vasculitis has high sensitivity and specificity for vasculitis. A     positive ANCA test result in those patients who do not have a high probability for vasculitis     requires extensive follow-up because those patients eventually present with malignancy or     other inflammatory diseases. The investigators wish to investigate the correlation between     the differing levels of positive ANCA tests and their relationship to vasculitis, malignancy     and inflammatory diseases.   "
84648|NCT02178046|"     There is a need for toothpastes that more effectively remove oral plaque and prevent     re-formation. The objective of this study is to map the development and resolution of     clinical gingivitis using conventional clinical examination and imaging data to determine how     useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth   "
86617|NCT02152306|"     The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in     hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with     hypertension who have no response to Fimasartan 60mg monotherapy.   "
84490|NCT02180113|"     FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in     Europe since December 2003 and is currently used in many countries. FibroScan® is an     ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to     liver stiffness measurement (LSM).      Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver     fibrosis.      Some other studies have already shown the good correlation between LSM, assessed by     FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).      PHT is a clinical condition characterized by a high blood pressure in the portal vein and its     tributaries and it is defined as a gradient between portal and systemic blood pressure > 6     mmHg.      The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential     bleeding, represent one of the most severe and life-threatening complication of cirrhosis.      Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices     or congestive gastropathy, for estimating the grade of OV and for the recognition of the     presence of red color signs and wale marks or other indicators of high risk for bleeding.      However these two methods are quite invasive and associated with some risks; at the same     time, not all cirrhotic patients present OV at endoscopic screening.      The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition     parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence     of OV in liver cirrhosis patients.   "
84491|NCT02180100|"     The objectives of this study were to demonstrate comparable safety and efficacy of     Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with     severe vulvovaginal candidiasis.   "
84492|NCT02180087|"     Currently, the management of pain after cardiac surgery is based on the concept of multimodal     analgesia: Combined use of non-opioid analgesics associated with morphine intravenous     analgesia by a system controlled by the patient (patient-controlled analgesia-PCA).      The combination of paracetamol and morphine PCA is very effective on pain at rest, but is     limited on pain mobilization and causes the problem of side effects associated with opioid     (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention     ...) which are contributing factors to increase the length of stay in Intensive Care Unit, an     additional cost of care and an increase postoperative morbidity and mortality.      Methods that have proved their effectiveness on pain and mobilization used in postoperative     cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia     techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in     morphine consumption, improved postoperative pain, decreased sedation and decreased     postoperative morbidity and mortality.      Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently,     NSAIDs, in the absence of against-indications, should always be prescribed and used at the     lowest effective dose and for the shortest possible time.      Some studies have suggested that lower doses of NSAIDs didn't appear to affect their     effectiveness. At present, the investigators have no studies that address the hypothesis from     which minimum dose of ketoprofen analgesic effect is obtained.      The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the     postoperative mobilization of cardiac surgery. The investigators want to find, in their     study, this optimal ketoprofen dose which would be the minimum dose for clinical efficacy     demonstrated dose.      This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will     probably not have enough power to prove it. NSAID use at these low doses, in postoperative     cardiac surgery, could be extended to patient populations most at risk or for a duration     longer than 48 hours.   "
84493|NCT02180074|"     Cardiovascular disease which includes coronary artery disease and peripheral artery disease     remains the leading cause of death among women in the United States. The impact of     cardiovascular in women was not recognized by clinicians for a long time. It is now evident     that, women suffer the consequences of cardiovascular at rates at least as high as those     observed in men but there are still major gaps in our understanding this disease in women.     Hydrogen sulfide (H2S), a gaseous mediator plays an important role in the cardiovascular     system. Research has demonstrated it's critical role in animal ischemia reperfusion models.     Hydrogen sulfide exists in distinct biological pools in blood. Recently, the Kevil lab has     pioneered the development of new analytical techniques for accurate measurement of all     biological pools of H2S. By measuring these distinct pools of H2S in women with and without     cardiovascular disease the investigators hope to further understanding of role of H2S in     pathophysiology of cardiovascular disease. This research will help to assess the ability of     H2S and its distinct biological pools to potentially be a diagnostic marker or a therapeutic     target for cardiovascular disease.   "
84495|NCT02180048|"     The purpose of this study is to observe effects of caffeine on overactive bladder symptoms     and wellbeing. This study looks at whether caffeine has bad effects on urinary symptoms or if     lower doses of caffeine decrease the effects.      The study will propose the following hypothesis:        1. The voiding and mental health symptoms will be greatest in the high dose treatment and          lowest in the placebo treatment.        2. The low dose treatment will produce more voiding and mental health symptoms than the          placebo treatment.        3. Voiding and mental health symptoms will be mediated by hydration status of the patient          which will be assessed using a Tanita Scale.   "
84496|NCT02180035|"     To evaluate if nutritional treatment with nutritional supplementation of dietary fiber     reduces cholesterol levels and triglycerides (dyslipidemia) in patients with HIV/AIDS     receiving antiretroviral therapy (HAART).   "
84497|NCT02180022|"     Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial     function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study     was designed to investigate whether consumption of onion peel extract (OPE) improves     endothelial function in healthy overweight and obese subjects.   "
84498|NCT02180009|"     In this study, the investigators will dynamically detect the expression of an immune     regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.   "
84499|NCT02179996|"     Preterm neonates are fragile to infections. Their immune system is immature, yet in France,     primary vaccines are injected at two months of age, as in term infants.      Recommendations for vaccinations in infants have changed in France in 2013, suppressing the     second injection at three months after birth. Preterm and full-term born infants are now     vaccinated at two and four months of age, but no data regarding efficacy in very preterm     infants have been registered.      The investigators hypothesize that two vaccine injections (at two and four months) would be     less efficient than three injections (two, three and four months) in very preterm-born     infants.   "
84679|NCT02177630|"     The purpose of this study is the assess the diagnostic performance of magnetic resonance     imaging in patients with suspected myocarditis by applying different imaging sequences at     different MR scanners   "
84501|NCT02179970|"     Pancreatic, ovarian and colorectal cancers are difficult to treat using chemotherapy and     immune therapies.Currently most patients are offered treatment with a standard chemotherapy     drug depending on their cancer type. Recently, laboratory studies have shown that a drug     called plerixafor may help the body to overcome resistance to immune therapy.      The purpose of this study is to find out if the study drug has the same effect on patients     with advanced pancreatic, ovarian or colorectal cancer, as we have seen in our laboratory     experiments, and find out the right dose of the study drug to give. This is a 'dose     escalation study'. Patients will be recruited slowly and the study team will closely monitor     the effect the drug has, until they find the best dose to give. As part of this study, blood     and tumour samples will be collected and analysed in our laboratories and the patients cancer     will be monitored using two imaging techniques, CT and FDG-PET scans.   "
84502|NCT02179957|"     The identification of abnormal narrowing of a blood vessel from non-invasive coronary     angiography remains an exciting goal. While Computed Tomography (CT) has established a clear     role in patients it retains some limitations. Primarily, alterations in blood flow leading to     a restriction in blood supply to tissues cannot be accurately predicted from the anatomical     assessment of an abnormal narrowing in a blood vessel - a limitation of both invasive, and     computed tomographic, angiography. This is important, as there is now a raft of evidence     demonstrating that revascularisation should only be considered in the presence of a     restriction in blood supply to tissues.      The gold standard method of identifying a restriction in blood supply to tissues is     measurement of the fractional flow reserve (FFR), a dimensionless value generated as a ratio     between the circulatory pressure before and after a narrowing of a blood vessel.      At present, patients with indeterminately significant abnormal narrowing in a blood vessel     identified using CT must go on to have a further test for a restriction in blood supply to     tissues, prior to any decision about revascularisation being made.      As part of our governance commitment to maintaining our reporting standards, we undertake     ongoing audit of our cardiac CT practice. The investigators recently identified a group of     patients who have undergone FFR measurement as part of routine clinical care, and compared     these to our clinical reports, to ensure that appropriate recommendations were being made. It     appeared that the ability to predict important abnormal narrowing in a blood vessel was     reasonable (~70%) and hence we propose the formulation of a research question to explore this     further.      The primary objective of this study is to determine the accuracy of a visual assessment of     the likely significance on blood flow of a narrowing of a blood vessel identified on cardiac     CT, in comparison to invasive, fractional flow reserve.      The secondary objective is to evaluate features of an abnormal narrowing in a blood vessel     that is likely to have a significant impact on blood flow.      The investigators' working hypothesis is that cardiac CT FFR is a useful predictor of     abnormal narrowing in a blood vessel.   "
84503|NCT02179944|"     This project will be a prospective physiologic study. We will closely follow 60 medication     abortion patients with serial repeat serum hCG and urine semi-quantitative hCG testing. We     plan to recruit patients from two gestational age strata: ≤ 49 days and > 49 days.      Study Objectives:        1. To create a nomogram describing the change in serum hCG values in the first five days          immediately following medication abortion with mifepristone and misoprostol.          Specifically, we will describe the percent serum hCG decline from Day 1 (day of          mifepristone) to Day 3 (day after misoprostol), from Day 1 to Day 5, and from Day 1 to          Day 7-10.        2. To explore whether there is a significant difference in the rate of hCG decline based on          initial gestational age determined by ultrasound and initial serum hCG.        3. To describe the correlation between semi-quantitative urine hCG test results and serum          hCG values to determine how soon after initiating medication abortion the urine test can          detect completed abortion.      We hypothesize that among successful medication abortions, there will be a predictable trend     with at least a 50% drop by Day 3 and 80% drop by Day 5.   "
84504|NCT02179931|"     To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet     formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation     of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.   "
84505|NCT02179918|"     This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum     tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a     4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in     patients with solid tumors.   "
84506|NCT02179905|"     This study is to analyze the relationship between brain structure, the heart rate variability     and the serum fatty acid component of the irritable bowel syndrome patients.   "
84550|NCT02179333|"     The objectives of this study are:        -  To validate the inter-rater and intra-rater reliability of a new scale for the          assessment of ataxia and neurologic dysfunction (STAND)        -  To assess common constructs and correlation between STAND subscale items.   "
84507|NCT02179892|"     The purpose of this study is to compare the efficacy and duration of bupivacaine     extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in     transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory     University Hospital and Emory University Hospital Midtown.      The investigators hypothesize that Exparel will provide greater postoperative pain relief     than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and     female subjects meeting inclusion and exclusion criteria who will be randomized to receive     either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the     TAP block to achieve at least 22 subjects in each group   "
84508|NCT02179879|"     Procedural skills play an important role in anaesthetic expertise. More focused training and     assessment of procedural skills will be needed in the future as training moves from an     apprenticeship based training system to competency based assessment.      Currently various techniques exists to assess procedural skills of anaesthetist. For epidural     catheter placement, task specific check list, global rating scales and cumulative sum     techniques have been developed and validated. These techniques aim either for better     qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in     objectivity in turn hampers inter-rater reliability which is an essential component of a     valid assessment model. Checklists type assessments force the developer to comprehensively     characterize the procedure of interest and then validate the completed procedure     characterization. This approach has been quantitatively shown to have higher assessment     reliability levels compared to Likert-scale assessment.      The objective of the project is to develop and validate a comprehensive procedure     characterization for labor epidural catheter placement. Another objective is to compare this     new assessment tool with existing checklist and global rating scale for labor epidural to     establish concurrent validity.5 A well-developed objective, validated procedure     characterization serves as a master tool which has multiple applications. It helps to build a     training programme for the procedure, allows providing metrics based feedback to trainees     using simulator, helps to assess the performance of trainees and in future might be used as     benchmark to allow competency based progression in the training.   "
84509|NCT02179866|"     This study is designed to investigate the absorption, distribution, metabolism and     elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male     participants.   "
85130|NCT02171741|"     Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW     2992 when administered in combination with docetaxel as determined by drug-related adverse     events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.   "
84510|NCT02179853|"     Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the     developed world. Despite available treatment, 25% of children in San Diego County     appropriately treated for KD develop coronary artery abnormalities that may lead to     complications later in life, including heart attack. Although the investigators can identify     children with KD that have these coronary artery abnormalities, there is no approved     additional treatment to decrease coronary artery inflammation and arrest or prevent damage to     the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1)     that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent     the development of coronary artery damage. Therefore, the investigators propose to study the     safety and activity of anakinra in infants and children < 2 years old with coronary artery     abnormalities from KD.   "
84511|NCT02179840|"     One of the fundamental goals of anesthesia care is to optimize tissue perfusion and     oxygenation, especially in critically ill patients. The standard monitors such as blood     pressure, heart rate and pulse oximetry do not directly reflect tissue information and can be     misleading sometimes. Coherent hemodynamics spectroscopy (CHS) based on cerebral oximetry is     proposed as a continuous and non-invasive tool assessing cerebral microvascular hemodynamics.     The investigators propose this study to explore the validity of CHS via comparison with     transcranial Doppler measurement in anesthetized surgical patients. The hypotheses are: 1)     CHS can effectively measure cerebral microvascular hemodynamic changes associated with     mechanical ventilation adjustment during anesthesia. 2) CHS can assess functional status of     cerebral autoregulation that is altered by hypercapnia and inhalational anesthetic agent.   "
84512|NCT02179827|"     The aim of this study is to assess the responsiveness of the standard minimally invasive     hemodynamic monitors used in the operating room to known changes in the intravascular volume     status that occur during blood removal and volume replacement with three different standard     fluids used during ANH.   "
84513|NCT02179814|"     Bulimia nervosa is a severe psychiatric disorder characterized by recurrent binge eating     episodes followed by inappropriate compensatory behavior to prevent weight gain such as     self-induced vomiting. With this project, the investigators want to investigate the role of     the neurotransmitter dopamine in bulimia nervosa. Dopamine is reported to have an important     influence on the neural reward system and is involved in the processing of gains and losses.     The reward system is functionally connected to the individual perception of rewards in the     environment. A previous study revealed that under catecholamine depletion including dopamine     depletion women suffering from bulimia nervosa in their past reported mild bulimic symptoms     and their reward processing became dysfunctional: their ability to use rewarding stimuli for     task solving was diminished.      The aim of this study is to investigate the role of reduced dopamine availability in the     development or maintaining of bulimia nervosa and in the dysfunctional processing of     rewarding stimuli and negative visual information. Therefore, the investigators hypothesize     that catecholamine depletion achieved by oral administration of alpha-methyl-paratyrosine     (AMPT) will induce mild bulimic symptoms in females suffering from bulimia nervosa in their     past. In addition, they will reveal dysfunctions in reward and emotional processing under     catecholamine depletion. Using functional magnetic resonance imaging, the investigators     propose that a reduced activation of the nucleus accumbens, a neural structure of the reward     system, will be the neural correlate of this dysfunctional reward processing. Furthermore,     the amygdala, a neural structure that is involved in emotional processing, will show a higher     activation under catecholamine depletion. Genetic factors additionally have an influence on     the dopaminergic system. Therefore, the investigators hypothesize that genetic factors, for     example the COMT val-158-met polymorphism may have an effect on the behavioral and neural     response to catecholamine depletion. In sum, this investigation may help to understand which     changes in reward and emotional processing may lead to a reoccurrence of bulimic symptoms.      In future, the findings of this study may help to develop individual pharmacological and     psychotherapeutical interventions to enhance the outcome of treatment.   "
84514|NCT02179801|"     The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is     to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms     in these patients should be identified at an early stage and thereby AAA-associated mortality     be decreased.   "
84551|NCT02179320|"     AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the     pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS)     patients.   "
84515|NCT02179788|"     Most new mothers in the United States will start off breastfeeding. For some mothers, despite     following best practices, they are not able to meet their breastfeeding goals due to     unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic     (elevated blood sugar, but not yet diabetic). My progression of research suggests that the     same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is     a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale     randomized trial designed to test for a trend in the hypothesis that metformin is safe and     potentially effective in treating low milk supply in insulin resistant and pre-diabetic     mothers.   "
84516|NCT02179775|"     The purpose of this study is to determine whether Quince Oxymel is effective in the     prevention of Migraine attacks in patients with simultaneous upper gastrointestinal     dysfunction.   "
84517|NCT02179762|"     This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing     active surveillance in patients with prostate cancer that has not spread to nearby lymph     nodes or to other parts of the body. Active surveillance involves watching the patient's     condition but not giving any treatment unless test results show that the patient's condition     is getting worse. Exercise may improve fitness, quality of life, brain health, and blood     biomarkers in patients with prostate cancer on active surveillance. It is not yet known     whether vigorous or moderate exercise works better in enhancing active surveillance in     patients with localized prostate cancer.   "
84518|NCT02179749|"     This is an 8-week, randomized, double-blind, placebo-controlled, 3 arm, parallel groups,     dose-ranging study of 1-week of treatment with mifepristone (0, 600, 1200 mg/d) given in     conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.   "
84519|NCT02179736|"     This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in     correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate     the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment.   "
84520|NCT02179723|"     This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar     incisions are greater or equivalent to those provided by the standard therapy of     transcutaneous sutures.      In particular, it tests the long-term cosmetic result after 3 months, the safety and     tolerance, as well as the practicality of treatment with Leuksan Adhesive.      An open, randomised, controlled, prospective, single location, clinical study of women of     ages between 18 and 60 years within the time span of March 2013 and April 2013.   "
84808|NCT02175927|"     No trial has examined the the efficacy of high dose amoxicillin based quadruple therapy as     second-line treatment for Helicobacter pylori infection. The study aims to compare the     effectiveness and safety of 14-day high dose amoxicillin-based quadruple regiment with     classical quadruple regiment for rescue eradication of Helicobacter pylori.   "
84809|NCT02175914|"     Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world     with a lifetime risk of 6%. Etiology is complex, while genetic background significantly     affects the risk. Around one third of all genetic disorders as well as most cases of Familial     Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a     result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous     polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that     prematurely halt the protein translation process, producing a shortened, nonfunctional     protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop     codon signal, the resulting protein may be able to ameliorate or stop the disease.      Recently, members of the aminoglycoside family of antibiotics have been found to induce     ribosomal read-through of nonsense mutations, leading to expression of a full length,     functional protein. Investigators have recently shown that members of the aminoglycoside and     macrolide antibiotic families can induce read-through of the nonsense mutations in the APC     gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.      The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin     to induce read-through of the nonsense mutations in the APC gene and to induce expression of     a full length, functional APC protein in patients suffering from FAP and to tests its effect     on adenoma number and size and on desmoid tumors in these patients. The future goal is to     maximize the effect of stop-codon suppressors on APC while minimizing side effects.      In this study investigators will select FAP patients which carry APC nonsense mutations,     treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as     well as abdominal desmoid tumors, that will be documented before during and after treatment.     In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as     blood samples from these patients for changes in expression levels of the APC protein and     related oncogenic markers.      Suppression of nonsense mutations within the APC gene should be of benefit for patients     suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or     diffuse CRC. Furthermore, given the rapid progress being made in the identification of     different nonsense mutations in human genes that lead to mostly un-curable disease, the     identification of clinically approved compounds that suppress nonsense mutations and that can     be administered long-term without significant side effects would open new venues in the     treatment of genetic human diseases that arise from pre-mature stop codons in important     coding sequences.      Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation     in FAP patients. The read-through effect of erythromycin will be clinically tested by     counting and measuring the number and size of both colonic and duodenal adenomas before and     over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and     desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry     for restoration of APC expression and changes in oncogenic markers. These experiments should     be conducted within 6 month.      Long term objective:        1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia          and CRC in patients expressing a truncated APC protein due to nonsense mutations.        2. Examine the ability of a panel of additional macrolide antibiotics to induce APC          nonsense mutation suppression using in-vitro methods. Investigators will focus on          macrolide antibiotics that are currently in clinical use and are administrated for long          terms. These objectives should take around 6 month and will be conducted in parallel.   "
84521|NCT02179710|"     Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains     discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic     saline. Programs to enhance adherence, including comprehensive behavioral interventions with     adolescents, have met with mixed success. Advances in therapy, treatment delivery systems,     and data capture technology offer the potential for enhancing adherence by providing     immediate and more frequent feedback to the patient regarding his or her fidelity to the     prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a     systematic approach to linking treatment and feedback components to enhance adherence.   "
84522|NCT02179697|"     The purpose of this study is to compare surgery plus bracing versus bracing alone. Both     groups are considered standard of care treatments. The goal of this study is to determine     which group is a better treatment.   "
84523|NCT02179684|"     The purpose of this study is to investigate if an early surgical intervention on patienst     with Bell´s Palsy has a better impact on their facial muscular function and their quality of     life as compared to conventional therapy.   "
84524|NCT02179671|"     Primary objective: To assess the efficacy of various sequences of either a small molecule or     an IMT (IMT-A) followed by a IMT-B (MEDI4736) .   "
84525|NCT02179658|"     The primary objective of this study is to investigate the safety and efficacy of OPT-80     versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).   "
84526|NCT02179645|"     A Single Dose Study of GRC 27864 in Healthy Volunteers.   "
84527|NCT02179632|"     Pharmaceutical and medical device manufacturers work closely with doctors and hospitals, and     the companies often pay large sums for consulting and advising services. Recipients of these     payments and companies have stated that these financial relationships contribute to     innovation in health care. However, multiple studies have also found that such payments have     the potential to bias prescribing and treatment behaviors, and thus may lead to increases in     health care costs.      One way to address potential conflicts of interest in medicine is public disclosure. As part     of the Affordable Care Act, the Physician Payment Sunshine Act (PPSA) will establish a     national disclosure website that posts all payments from pharmaceutical, medical device, and     biologics manufacturers to doctors and hospitals starting in 2014. Payments exceeding $10     must be reported, and they will be listed by category, such as speaking engagements, meals,     travel, and consulting services.      The Centers for Medicare and Medicaid Services (CMS) explicitly state in their Final     Regulations for the PPSA that the disclosure website will permit patients to make better     informed decisions when choosing health care professionals and making treatment decisions,     but the ways in which patients will evaluate and interpret disclosure remain unclear. One     prominent topic in the discussion of disclosure is patient trust in health care providers and     how transparency will affect the patient-doctor relationship—and, consequently, how the new     law may affect physicians and hospitals.   "
84544|NCT02179411|"     Autonomic nervous system contributes to the regulation of renal blood flow, affected by     upright posture. Kidney transplantation implies sympathetic denervation. The aim of this     study is to compare the renal vascular response in volunteers and renal graft recipients to     an orthostatic stress induced by a head-up tilt test. Renal peripheral resistances are     assessed by echo Doppler. The sympathetic nervous system activity is evaluated by plasma     concentrations of catecholamine before and after the head-up tilt test.   "
84528|NCT02179619|"     The study is to verify that Dermalax (Deep) is not inferior to the reference device,     Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects     who voluntarily signed the informed consent and are judged to be eligible for this study will     be intradermally injected both of study device and comparator device. Subjects will be     randomized to receive injection of study device and comparator device on their each     nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale     (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject     diary which will be given to subjects during the first 2 weeks after the injection. Any     uncomfortable things and adverse events will be investigated from subject diary and follow up     visits.   "
84529|NCT02179606|"     This study is to verify that Dermalax Implant Plus is not inferior to the reference device,     Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds   "
84530|NCT02179593|"     A few studies state that 3-segment SARPE has the following advantages: a) higher level of     expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster     bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment     SARPE concerning treatment and/or quality of life in daily practice.   "
84531|NCT02179580|"     Ministry of Health and Welfare Department of Chinese Medicine and pharmacy specially     subsidizes domestic teaching hospitals to install clinical study centers for Chinese     pharmacies, in order to establish the clinical study environment for Chinese pharmacies     meeting the international regulations, to assist promoting and performing clinical studies in     Chinese pharmacies, and then to improve the nation's health and benefits. This will render     Chinese pharmacies competitive in the international market by employing scientific tests and     verifications. The new project applications are respectively as follows: A randomized double     blind placebo control study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) in patients with irritable     bowel syndrome The main clinical manifestations of irritable bowel syndrome (IBS) are     chronic, recurrent abdominal pain or abdominal dyscomfortable associated with the changes of     defecation habit, such as constipation and/or diarrhea. Clinical treatment of IBS includes     behavioral, and drug treatment, such as anti-diarrheal agent, 5-HT3 receptor antagonist and     5-HT4 receptor agonist, but these treatments relieve partial symptoms only.     Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) origins from Yizongjinjion, and that uses XSLJZT to treat     the patients who has qi deficiency, phlegm-retained fluid, nausea and vomiting,     gastrointestinal dysharmony and producing many symptoms. These symptoms of mentioned-above     are similar to IBS. Therefore, the purpose of the present study was to investigate the     therapeutic effect of XSLJZT on IBS, the investigators designed a randomized double blind     placebo control study to assess the effect of XSLJZT on IBS.   "
84532|NCT02179567|"     The investigators propose to study the efficacy and safety of the combination of Docetaxel     plus Bevacizumab in a Phase II trial of elderly subjects with non-small cell lung cancer   "
84680|NCT02177617|"     This study aims to compare Botox injections without Physical Therapy sessions to Botox     injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is     expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms     and quality of life more than Botox alone. It is also expected that Botox combined with     Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new     connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox     injection.   "
84533|NCT02179554|"     The loss of the sense of smell, anosmia, can have profound effects on the lives of those who     suffer from it. In our clinical practice, we have encountered several patients complaining of     anosmia after recently undergoing surgery requiring cardiopulmonary bypass. We want to     investigate this peculiar observation and determine if such a link exists. Thus far, there     have been no similar studies published, and as such, no previous evidence on this matter.     This study will help formalise and clarify these observations, empowering clinicians to     better inform patients in the future; if cardiopulmonary bypass procedures do carry a risk of     anosmia. This study may also give rise to further research into the matter.   "
84534|NCT02179541|"     Otitis media with effusion (OME) cases refer to a clinically silent condition. Otoscopic     findings are subjective and not always reliable. As an objective test tympanometric     evaluation is imperfect for diagnosis of OME. The objective of our study was to investigate,     in OME cases, the correlation of tympanic membrane color changes with the presence and     viscosity of effusion in the middle ear. The study aimed to provide objective diagnostic and     therapeutic criteria for patients scheduled for surgery by 2 means: measuring the viscosity     of the fluid and evaluating color changes objectively with red-green-blue (RGB) measurements.   "
84535|NCT02179528|"     Patients with extensive-stage small cell lung cancer receive six cycles of     chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete     Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance     treatment. The objective of this study is to evaluate the progression free survival,overall     survival,objective response rate,disease control rate and safety of etoposide as maintenance     therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the     hypothesis of this study is maintenance therapy using etoposide may improve progression free     survival,overall survival for selected patients. The investigators will use the peripheral     blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a     subgroup of patients with better response to etoposide maintenance therapy.   "
84545|NCT02179398|"     Detecting serious bacterial infections (SBI) in children presenting to the Pediatric     Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic     challenge. The recently described Lab-score, based on the combined determination of     Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an     accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess     the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in     children with FWS, and to prospectively determine the diagnostic characteristics of the     Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count,     band count and CRP).   "
84546|NCT02179385|"     CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle     and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.      Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence     improves self treatment among uncontrolled diabetic patients.   "
84536|NCT02179515|"     Background:      - This cancer vaccine was developed to help teach the body's immune system to attack and     destroy cancer cells. It teaches immune cells to target the Brachyury protein. This protein     is present in some tumor cells, and it can help tumor cells spread to other parts of the     body. Researchers want to see whether the new Brachyury protein vaccine can help treat people     with advanced carcinomas.      Objective:      - To test the safety and effectiveness of giving the MVA-brachyury-TRICOM vaccine to people     with cancer.      Eligibility:      - Adults ages 18 and over whose type of cancer has not responded to standard therapies who do     not have a history of autoimmune diseases and are capable of taking care of themselves.      Design:        -  Participants will be screened with a medical history and physical exam. They will have          blood and urine tests. They may have a computed tomography (CT) scan, a positron          emission tomography (PET) scan, and a brain magnetic resonance imaging (MRI) scan. They          may have a bone scan. They will have an electrocardiogram (ECG) to test heart rhythm.        -  Participants will have visits about every 4 weeks. They will have a physical exam and          blood and urine tests. They will be injected with the vaccine under the skin into the          upper thigh or around the armpits.        -  CT scans or MRI scans will be done at visit 1, after 3 months on study, and again 3          months later if still on the study. Another ECG will be done at their last vaccine          visit.        -  When participants stop the vaccine, they will return for visits until they recover from          any side effects. They will have tests including physical exam, blood tests, scans, and          x-rays.        -  Participants will be asked to enroll in another study for long-term follow-up.   "
84537|NCT02179502|"     The purpose of this First-in-Human study is to evaluate the safety and tolerability after     single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo.     Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to     healthy male subjects daily for 14 days compared to placebo, will be evaluated.      Furthermore, during the course of the study after single and multiple oral dose     administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as     well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics)     will be characterized compared to placebo.      The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of     a liquid dosage formulation of GLPG1690.      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690     will be explored.   "
84538|NCT02179489|"     Multicentric randomised trial. The goal of this clinical research study is to learn if     hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of     peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal     cancer. The safety of this treatment will also be studied.   "
84539|NCT02179476|"     A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in     subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful     neural ablation in which the facet joint is confirmed as the source of pain.   "
84540|NCT02179463|"     RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric     cancer, yet the best pattern of response evaluation remain unknown.      PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.   "
84541|NCT02179450|"     Based on recent findings that botulinum toxin injections in the cranial muscles might reduce     emotional processing (Havas 2011), an increasing number of popular newspaper tabloids are     suggesting a negative effect on cognition. The underlying research articles address the     facial feedback hypothesis. The hypothesis indicates that expressive behaviour, including     facial mimic expressions influences the subject's brain via feedback. (Alam 2008) Other     systemic neurological diseases, e.g of inflammatory origin, may lead to temporary bilateral     facial nerve palsy (BF). During recovery process, the palsy usually remits completely.      The effect of bilateral facial muscle palsy on cognition and emotional possessing has never     been evaluated.      The results of this pilot study might provide new information about the effect bilateral     facial palsy on emotional processing and cognition and the facial feedback hypothesis.      The aim of this controlled pilot study is to assess cognitive function and emotional     processing in patients with bilateral facial palsy. In addition, differences in cognitive     function and emotional processing in patients with different manifestations of dystonia     should be evaluated.      According to the facial feedback theory, paralysed mimic muscles might alter emotional     processing. Therefore, investigators compare patients with bilateral facial muscle palsy and     healthy controls. Investigators expect no influence of facial muscle palsy on cognitive     functions in any of the tested groups; the investigators expect a mild impairment of     emotional processing only in the patients group with bilateral facial muscle palsy (BEB and     BF). In addition, the investigators expect no difference in emotional processing in patients     with different manifestations of dystonia (BEB and CD) at remission. There might be a slight     difference of emotional processing in patients with different manifestations of dystonia (BEB     and CD) at time of prominent facial palsy.   "
85131|NCT02171728|"     Investigation of maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamic     parameters, and efficacy of BIBW 2992   "
84542|NCT02179437|"     Postoperative pain can be severe after liver resection surgery. However, postoperative pain     management may be difficult for this group of patients. Opioidergic neurotransmission may be     altered in cirrhotic patients and selectively increasing receptor affinity for opioids. Large     dose of strong opioid may be required to achieve adequate pain control. However, this may not     be possible due to the side effect of opioid and liver dysfunction after liver resection.      Propofol is a commonly used anaesthetic with rapid recovery and less side effects and TIVA     (total intravenous analgesia) with propofol is a common technique now. The reduction on     certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.      Recent case report proved the analgesic effect of propofol infusion. However other animal and     clinical studies showed controversial result.      The aim of this retrospective study is to investigate the postoperative analgesic effects and     side effects of intraoperative TIVA with propofol in patient undergoing liver resection     surgery at Queen Mary Hospital, Hong Kong between 2010 to 2012.   "
84543|NCT02179424|"     Previous research shows a significant proportion of smokers work in full-time employment.     Given that the majority of smokers do not aware of the smoking cessation services available     in Hong Kong, implementing smoking cessation policy in the workplaces may assist a     considerable number of smokers to stop or reduce smoking.      This study aims to:        1. examine the employers' knowledge, attitudes and practices in promoting smoking cessation          in workplace.        2. test the effectiveness of a brief and an intensive smoking cessation interventions to          help workers stop smoking      In Phase I of this study, a large scale cross-sectional survey will be conducted to 3000     corporate companies in Hong Kong. The questionnaire will examine the employers' knowledge,     attitudes and practices in promoting smoking cessation in the workplaces.      In Phase II, a longitudinal study will be conducted to evaluate the effectiveness of a     smoking cessation intervention offered by the Department of Psychology, the University of     Hong Kong. Smokers from the participating companies will be interviewed before the     intervention at baseline, immediately after the intervention, and at 1-, 4-, 12-, 26- and     52-week post-intervention follow-ups.      The follow-up assessments will consist of a biochemical validation for the self-reported     quitters who report quitting in the past 7 days via exhaled carbon monoxide and saliva     cotinine concentration tests. Participants' smoking behaviour, knowledge on smoking and     satisfaction of the smoking cessation services will also be evaluated.      It is hypothesized that the smoking cessation intervention helps workers stop smoking.     Employers' knowledge and attitudes are positively associated with the practices in promoting     smoking cessation in workplace.      Process evaluation: Qualitative interviews, including in-depth interviews and/or focus group     will be conducted after 6-month follow-up.   "
84552|NCT02179307|"     The literature is not clear as to which training volume to employ during initial phases of     resistance training programs to ensure optimal muscular adaptations. The purpose of this     study is therefore to compare effects of strength training with low versus moderate volume on     muscular function and hypertrophy in previously untrained, healthy individuals. Furthermore,     the investigators will relate individual variation in responses to proxy markers of     individual training state, such as baseline muscular function and muscle fiber type.      The study will include 25 women and 25 men and will consist of a 12-week resistance training     protocol. Each study participant will act as their own control, performing both the low-     (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or     non-dominant leg, in a stratified and randomized fashion.      Primary outcome measures are thigh muscle cross section area and unilateral knee extension     strength. Additionally, muscle fiber type composition will be evaluated as well as additional     parameters of muscular function.      The primary hypothesis is that low-volume protocols will be beneficial for individuals with     glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more     aerobic phenotypes.   "
84576|NCT02178982|"     The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases.     In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of     death in patients. There is no unified treatment process for ARDS currently and the treatment     measures are not yet standardized, so the standardization of ARDS treatment processes is     needed to reduce mortality in patients. Following the evidence-based medicine principles and     six-step treatment standards of ARDS, this study uses the method of multi-center randomized     controlled clinical trials to evaluate the standardized treatment process of ARDS, which     provides the basis for the standardized treatment of ARDS.   "
84553|NCT02179294|"     Childbirth can be an extremely painful and the provision of pain relief during labour is a     vital component of a positive maternal experience. The majority of women who deliver in     modern obstetric units choose a pharmacological method of pain relief, including Entonox, the     injection of opioids or epidural placement. The commonest opioid used in labour is pethidine     administered by intramuscular (im) injection. The effectiveness of pain relief provided by     pethidine has long been challenged. Its shortcomings are more serious when set against known     side effects including maternal sedation, nausea and potential transfer across the placenta     to the foetus. More than a third of women who receive pethidine subsequently require an     epidural due to inadequate pain relief. Epidurals provide highly effective pain relief, but     increase the risk of a forceps or suction delivery resulting in prolonged hospital stay.     Therefore, there is a clear need for a safe, effective, easy to administer analgesic     alternative.   "
84554|NCT02179281|"     The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed     system significantly reduces hypoglycemic excursions and thus provide proactive protection to     the user.   "
84555|NCT02179268|"     The aim of this five arm randomized trial was thus to compare selective serotonin reuptake     inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a     nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the     primary endpoint being bone mineral density, and secondary endpoints being bone turnover     markers.   "
84556|NCT02179255|"     Synthetic human growth hormone (HGH) has been available for more than a decade for specific     indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under     off-label use) for improving ovarian function have shown that a combination of traditional     gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing     pregnancy rates, but not increasing egg production after IVF in women with documented     diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at     least 6 weeks prior to IVF start, the investigators will be able to increase production of     oocytes and further improve pregnancy chances. This hypothesis is based on prior observations     of effects of growth hormone on small antral follicles and the fact that prior studies     utilized HGH principally only during ovulation induction itself.      The investigators plan to recruit 30 women (15 in each group) to an open label randomized     controlled trial of HGH for augmentation of ovarian response among women with documented DOR     and poor prior response to ovulation induction.      Eligible participants will be women < 45 years with documented history of prior retrieval of     2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with     dehydroepiandrosterone (DHEA).      Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before     start of their treatment cycle. Cost of treatment with HGH will be a cost to the     participating patient. HGH will cost the patient approximately $800 per week of treatment.     Patients who are randomized to the non-HGH treated group, and do not conceive, will in the     following cycle be offered HGH supplementation outside of this clinical trial. This     subsequent cycle will not be part of the study dataset and patients will also be responsible     for the cost of HGH.      Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to     detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit     15 patients in each group to allow for possible dropouts.   "
84557|NCT02179242|"     The aim of the investigators' project is to determine if patients admitted with a primary     diagnosis of heart failure to Sanford Health facilities in regional southeastern South Dakota     demonstrate benefits in improvement in functional capacity, quality of life, and a reduction     in hospital readmission rates from a cardiac rehab program immediately following a discharge     for an acute decompensated heart failure diagnosis related inpatient hospitalization     encounter. The investigators hypothesize that those that receive cardiac rehab will have     improved quality of life and reduced readmission rates at 30 and 90 days.   "
84558|NCT02179229|"     The purpose of this study is to establish whether a short treatment with the synbiotic     combination Probinul neutro® may decrease the plasma concentration of the uremic toxin     p-cresol in patients bearing a kidney allograft. The effect of this treatment on plasma     levels of immunosuppressant drugs will be evaluated as well.   "
84559|NCT02179216|"     Primary objective: To compare the decrease in systolic blood pressure between hydration and     venous contention when switching to a standing position. Hypothesis in that hydration is     better than venous contention.      Secondary objective: To evaluate the effect of hydration on lowering systolic blood pressure     during the passage standing in elderly patients with orthostatic hypotension.      Inclusion criteria: Patient aged over 75 years old with orthostatic hypotension proved to 1     and / or 3 min   "
84560|NCT02179203|"     Study Purpose and Rationale The purpose of this study is to evaluate the lung Doppler signals     changes during cardiac resynchronization procedure. As the LDS represent the various     mechanical events of cardiac origin it is assumed that they may reflect the relative timing     between contraction of the ventricles and atria and thus serve for effective synchronization     of these activities.      Aim of the study:      The aim of the study is to assess whether the changes in Lung Doppler Signal (LDS) waves'     characteristics will mimic the changes in echocardiographic parameters designed to assess     diastolic inflow and systolic flow in patients undergoing Echo-based CRT optimization.   "
84562|NCT02179177|"     In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a     significant decrease in morbidity and as a result, decrease healthcare utilization and costs.     This study attempts to critically avoid admissions by reducing daily pain scores and pain     crisis as an outpatient by use of a novel oral anticoagulant.   "
84563|NCT02179151|"     The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese     adolescent and adult subjects with Prader-Willi Syndrome.   "
84564|NCT02179138|"     To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir     (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural     KwaZulu-Natal, South Africa.   "
84577|NCT02178969|"     The purpose of this study is to better understand disease extent and to identify appropriate     methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and     qualitative manner.   "
84578|NCT02178956|"     The purpose of this study is to find out whether it is better to receive a new drug, BBI608,     in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as     second line treatment for gastric and gastroesophageal junction cancer after prior first line     platinum and fluoropyrimidine based chemotherapy.   "
84579|NCT02178943|"     Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in     association with the measurement of AlloMap, a non-invasive gene expression test to aid in     heart transplant management.   "
84565|NCT02179125|"     Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a bronchoscopic     lung volume reduction treatment designed to compress the areas of lung parenchyma most     damaged by emphysema. The LVRC treatment was found to be feasible, safe and effective in     previous studies. However, patient-based outcomes besides quality of life questionnaires are     hardly measured after intervention treatments for COPD. Furthermore, the exact underlying     physiological mechanism of the LVR-coil treatment is unknown. Another aspect of the treatment     which we to date do not fully understand is which group of patients benefit of the treatment     and which group of patients do not, this knowing that the responder rate is already about     60%.      Objective: The objectives of the study are to gain more knowledge on 1) the effect of the     LVRC treatment on patient-based outcomes like physical activity, 2) the underlying     physiological mechanism of the treatment, 3) the predictors of response to the treatment at     baseline, and 4) on a targetted treatment number of coils to be placed per lung using lung     compliance.      Study design: This study is a non-randomised open label multi-center intervention study.      Study population: The study population exists of adult patients with severe emphysema with no     other treatment options left besides surgical procedures.      Intervention: Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.      Main study parameters/endpoints: The main study endpoint is the change in physical activity     between baseline and 3 months follow-up after the second treatment. The secondary endpoints     are the changes between baseline and 3 months follow-up after the second treatment in:     patient reported outcomes of the treatment, dynamic lung hyperinflation, static lung volumes,     lung compliance, diaphragm function, lung perfusion, systemic inflammation and small airways     function.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The LVR Coil has been designed to be as safe as possible. It was shown that the     risks associated with the LVRC system are largely attributable to the bronchoscopic procedure     itself rather than to the device per se. Therefore, it appears that the LVRC device itself     does not appreciably increase the risk of serious adverse events beyond the risk of     undergoing a bronchoscopy procedure or simply having emphysema. Currently, this treatment is     not commercially available in the Netherlands and study participants will have to visit the     hospital multiple times. Previous studies have shown that the treatment has beneficial effect     for the patient, however not all patients respond. Part of this new study is to try to     identify which group of patients respond to the treatment and which patients do not.     Therefore, it is possible that a patient will not receive any benefits from the treatment.   "
84566|NCT02179112|"     A multicentre, international evaluation of emergency abdominal surgery to establish surgical     outcomes and identify common, modifiable best practice processes.   "
84567|NCT02179099|"     This is a single arm pilot study evaluating the feasibility and preliminary safety of a     single intravesical instillation of TC-3 gel mixed with botulinum toxin (BTX) for symptomatic     improvement in overactive bladder patients.   "
84568|NCT02179086|"     This randomized phase II trial studies how well dose-escalated photon intensity-modulated     radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose     radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma.     Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells     and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.     Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is     not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more     effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.   "
84569|NCT02179073|"     Bladder management has a major impact on the quality of life in patients with neurogenic     bladder dysfunction. This a prospective investigation of the effects of the method for     bladder evacuation on the health-related quality of life in patients with neurogenic bladder     dysfunction. The changes in health-related quality of life over time (longitudinal     investigation) and the differences between the different methods for bladder evacuation will     be investigated. Patients will be given a standardized and validated questionnaire annually     for 10 years.   "
84570|NCT02179060|"     Therapeutic hypothermia improves the neurologically-intact survival rates in those patients     resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible     might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted     magnetic resonance imaging have recently shown to be able to identify early ischemia-related     changes within the brain three days after cardiac arrest, among sudden cardiac arrest     patients cooled in hospital. The physical changes seen within the brain may be able to     distinguish survivors at very early phase.      This study aims to assess early ischemia-related changes of the brain seen in MRI     approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the     groups of patients treated with early intra-arrest cooling with the RhinoChill device and in     hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital     hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital     hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint is     the presence and pattern of white matter and gray matter degeneration and volumetric changes     of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and secondary     endpoints are total survival at 90 days, and time to reach a target temperature (≤36/33     Celsius).   "
84571|NCT02179047|"     Through the literature review , we pick out a series of forward-looking biological indicators     as follows :        1. NGAL        2. Cystatin C:        3. Galectin-3:        4. Copeptin:        5. MR-Pro ANP:        6. sST2:   "
84689|NCT02177500|"     An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg     plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic     blood pressure in patients who fail to respond adequately to telmisartan monotherapy.   "
84572|NCT02179034|"     This study is to examine if inhaled doses of menthol that produce low and high cooling     effects change the appeal of e-cigarettes containing low and high doses of nicotine in     adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when     compared with menthol or nicotine alone, will result in greater increase in liking of an     e-cigarette and greater reduction in nicotine withdrawal.   "
84573|NCT02179021|"     The purpose of this study is to investigate, if the haemostasis is impaired in cardiac arrest     patients during therapeutic hypothermia compared with normothermia.   "
84574|NCT02179008|"     The purpose of this study is to investigate the safety and efficacy of five concentrations of     DE-117 ophthalmic solution.   "
84575|NCT02178995|"     Methylphenidate (MPH) has long been used to improve attention and cognitive difficulties     associated with ADHD, including in children with ADHD and epilepsy (Torres et al., 2008).     Methylphenidate (MPH) is also helpful in treating attention and other cognitive difficulties     in a variety of other neurological and medical conditions (Kajs-Wyllie, 2002; Prommer, 2012).     We seek to evaluate the potential efficacy and safety of this medication in treating     attention deficits, as well as other cognitive difficulties, experienced by adult patients     with epilepsy.      To our knowledge, there are currently very few studies which explicitly examine the impact of     MPH on measureable attention deficits and other cognitive deficits in adult patients with     epilepsy. We hope to quantify what impact, if any, methylphenidate has on attention, in     addition to other specific measureable cognitive functions, in patients with cognitive     complaints and epilepsy, and contribute to a growing body of evidence which supports the     safety of methylphenidate's use for attention deficits in patients with epilepsy. As other     effective treatments for attention and other cognitive difficulties in patients with epilepsy     are not currently available, MPH could represent an important option in the treatment of such     patients.   "
84580|NCT02178930|"     The purpose of this study is to improve the health status of people living with HIV in     Australia. The overall goal is to rigorously evaluate the impact of interactive health plans     and self-management support on chronic condition outcomes in people with HIV.      The specific aims are to:      Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive     health plans and self-management support on coronary heart disease risk and other chronic     condition outcomes in people living with HIV.      Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive     health plans and self-management support.      Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.   "
84581|NCT02178917|"     Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body.     SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP).     This pain typically develops several months after the injury. In 30-40% of SCI patients,     severe CNP affects their everyday living including sleep and mood. Many patients give up     work, not because of the injury, but because of pain. Medical treatment of CNP is moderately     effective and costly, both to the patient and to the health care system.      In previous research, characteristic 'signatures' of brain waves that are probably related to     CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback was     developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to     record patients' brain waves and these were shown to patients on a computer screen in a     simple graphical form (e.g. bars). Patients were trained to change their brain activity at     will and, as a consequence, their pain was reduced. Patients who had suffered from CNP for     years received up to 40 neurofeedback treatment sessions, reducing their pain for several     days after each session.      The primary aim of this study is to apply neurofeedback therapy to a larger number of     recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback     treatment will be more effective in people who have suffered from CNP for a shorter period of     time.      The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in     recently injured patients with no chronic pain, knowing that a certain number of patients     will develop CNP within weeks or months. These patients will be followed up for a year and     the EEGs of patients who develop CNP will be compared with those who do not.   "
84582|NCT02178904|"     The purpose of this study is determine the diagnostic performance of dual energy computed     tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary     stenosis, as compared to a direct measurement of fraction flow reserve during cardiac     catheterization as a reference standard.      The overall objective of the present study is to determine the diagnostic performance of dual     energy computed tomography perfusion for non-invasive assessment of the hemodynamic     significance of coronary stenosis, as compared to direct measurement of fraction flow reserve     during cardiac catheterization as a reference standard.   "
84583|NCT02178891|"     An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone     anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.   "
84584|NCT02178878|"     The purpose of this study is to try to understand why the experience of labor differs among     women. The investigators want to understand why some women have longer or shorter labors and     why the amount of pain women experience is different. The investigators hope to be able to     consider women more individually in terms of their pain and progress of labor.   "
84585|NCT02178865|"     The purpose of this study is to assess the accuracy of predicting the normal or carrier     status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a     balanced translocation.   "
84586|NCT02178852|"     Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed,     neuroimaging studies show changes in neural activity in specific brain regions such as the     amygdala, insula, precentral gyrus, hippocampus and thalamus. The neuroanatomical connections     established with the trigeminal nerve have been associated with the mechanism called     bottom-up neuromodulation. According to this hypothesis, the spread of electrical     stimulation follows a path from the peripheral nerves towards the brain stem was then     advertise for cortical and subcortical regions. Connections to structures involved in the     reward system as the amygdala and hippocampus could theoretically modulate dysfunctional     brain activity in these regions, which may induce favorable clinical effects.   "
84587|NCT02178839|"     The Objective of This Study is Evaluating the Effect of oral β- glucan Supplement on     Anthropometric Measurements, Appetite, Insulin Resistance, Liver echogenicity and Enzymes in     Non Alcoholic Fatty Liver Patients Treating with Hypocaloric Diet and Vitamin E.   "
84588|NCT02178826|"     Nocturnal enuresis (NE) is the involuntary loss of urine that occurs only at night in     children aged 5 years or more.      NE is a common problem, affecting about 10% of school children. The prevalence declines with     each year of maturity but for some it persists in to adolescents and early adulthood. It can     lead to bad self-confidence and low self-esteem, which can have psychosocial consequences.      NE is a multifactorial condition. Three central factors have been identified:      A) Many bedwetting children produce large amounts of urine at night due to a deficiency of     the antidiuretic hormone vasopressin.      B) Other children have a lack of inhibition of bladder emptying during sleep. C) Almost all     children are deep sleepers with high arousal thresholds. They simply don't wake up when the     bladder is full or when it contracts.      There are two well established and evidence based treatments today: the bed-wetting alarm and     the pharmacologic treatment desmopressin. The alarm emits a sound when the child wets the     bed, which conditions the child to wake up or inhibit bladder emptying. This method is     curative for about half of the patients who try this, but relapse occurs. Desmopressin is a     synthetic analog of arginine vasopressin and works by decreasing the urine volume at night.     About half of the patients become dry with this medication but only as long as they take the     medicine. To day, at least 25% of all children with NE do not respond to any of the above     treatment.      Rapid maxillary expansion (RME) is a common orthodontic technique to treat patients with a     narrow upper jaw. The brace is fitted by an orthodontist, and has a jack-screw, which is     activated twice every day for 10-14 days. The procedure is neither painful nor harmful and is     not very visible at all.      There are a few reports about children who have become dry after RME treatment. None of them     have been randomised or placebo controlled but indicates that quite a few children do become     dry after this treatment. A recently carried out study in Sweden show that half of the     children became dry after RME treatment. These children were all classed as therapy resistant     and had already tried the alarm and medication without success.      The reports are intriguing, but invite the question why a brace would help cure NE? It is     likely that sleep and respiration is involved. This study will investigate these children's     sleep during the treatment. The trial is a randomised, placebo controlled trial.   "
84607|NCT02178579|"     The purpose of this study is to better define and understand potential cardiac toxicity and     begin to understand optimal management strategies.   "
85661|NCT02164773|"     Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The     aim of the study is to delineate the effect of caudal magnesium sulfate in children     undergoing lower abdominal surgery to prevent postoperative emergence agitation.   "
84589|NCT02178813|"     The purpose of this study is to evaluate the safety and tolerability of high-dose minocycline     in the patient population undergoing carotid revascularization procedures, namely carotid     endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of safety will     facilitate proceeding to a phase II trial.      During this trial, patients undergoing carotid revascularization procedures will receive high     doses of minocycline with the following schedule (based on previous trials):        -  Day prior to procedure: 800mg orally (p.o), 700mg p.o.        -  Day of procedure: 600mg intravenously( i.v.), 500mg p.o.        -  Day after procedure: 400mg p.o., 400mg p.o.      The levels of the drug in the plasma, standard blood tests (complete blood count, creatinine,     liver function tests) as well as markers of neuronal injury (Neuron specific enolase,     protein- S100b) and inflammation (C-reactive protein) will also be monitored. The patients     will be monitored closely for the development of side effects from minocycline.      MRI imaging will be used to follow the development of small strokes as a result of the     revascularization procedures and their resolution. The patients of this study, all receiving     peri-operative minocycline, will be compared with historical controls with regards to     development of small strokes and persistent of these strokes on subsequent MRI imaging.   "
84590|NCT02178800|"     This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the     body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in     healthy, HIV-uninfected adults. Researchers will evaluate the use of this medicine for both     the prevention and treatment of HIV infection.   "
84591|NCT02178787|"     Cerebral autoregulation (CA) is a complex mechanism that serves the essential and vital     purpose of controlling cerebral blood flow and metabolism. A stable and optimal brain blood     flow is imperative for normal brain function. Diabetes Mellitus (DM ) is associated with     microvascular disease that alters CA and also with autonomic failure that may lead to     orthostatic hypotension (OH). These conditions may lead to decreased brain blood flow in     upright position. This observational study will compare two technologies that evaluate brain     blood flow during standing up and other maneuvers in people with and without type 2 diabetes.     These technologies are transcranial Doppler and UTLight technology (CerOx). This study will     determine the safety and feasibility of CerOx technology for continuous monitoring of     cerebral blood flow.   "
84592|NCT02178774|"     Hypotension after spinal anesthesia for cesarean section is one of the most common     perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the     associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower     extremities and an increase in venous capacitance. Hypotension is a distress for both     anesthesiologists and obstetricians as it endangers parturient's hemodynamics and compromises     the uteroplacental blood flow. In clinical practice, there are several ways to treat     hypotension after spinal anesthesia such as preloading with intravenous fluids and     administrating ephedrine. Normotensive maternal blood pressure does neither guarantee the     well-being of the fetus nor ensure the tissue perfusion of the parturient. Based on the     anatomy and physiology basis, we hypothesize that uterine perfusion under spinal anesthesia     would correlate with the perfusion of the lower extremities. To measure the perfusion of the     lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared     spectroscopy.   "
84593|NCT02178761|"     Erectile dysfunction is highly prevalent as men grow older. Among the various causes of     erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very     important role. The investigators have recently developed the first imaging analytical     algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT) angiography     to delineate the whole arterial system supplying the penis. To establish a comprehensive,     cutting-edge diagnostic and interventional therapeutic program for erectile dysfunction, the     investigators therefore design this series of studies by including experts from Urology,     Radiology, and Cardiology. This research project (PERFECT program) includes the following 4     sub-studies: 1) differential frequency of obstructive pelvic arterial lesions in coronary     artery disease patients with and without erectile dysfunction/lower urinary tract symptoms     (LUTS), 2) differential frequency of obstructive pelvic arterial lesions in patients with     vascular risk factors and with or without erectile dysfunction/LUTS, 3) safety, feasibility,     and efficacy of comprehensive pelvic angioplasty (with various interventional     strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive     arterial disease: proof-of-concept study; and 4) efficacy and safety of comprehensive pelvic     angioplasty (with various interventional strategies/instruments) for patients with erectile     dysfunction/LUTS and pelvic obstructive arterial disease: a randomized controlled trial.   "
84594|NCT02178748|"     Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects     humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality     and morbidity; development of an effective vaccine is a global health priority.      Over a billion people worldwide are infected with one or more helminths. Helminths are     parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that     helminth infection may affect a person's response to a vaccine. In this trial the     investigators hope to investigate whether Schistosoma mansoni infection affects adolescents'     responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group     for an effective TB vaccine.   "
84595|NCT02178735|"     To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh     surgeries.   "
84596|NCT02178722|"     The purpose of this study is to assess the safety, tolerability, and efficacy when combining     MK-3475 and INCB024360 in subjects with certain cancers. This study will be conducted in 2     phases, Phase 1 and Phase 2.   "
84597|NCT02178709|"     The primary objective of this study is to evaluate the rate of pathologic complete response     to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue     collection component.   "
84608|NCT02178566|"     The investigators' hypothesis is that pretreating patients with COPD with inhaled     treprostinil prior to pulmonary rehabilitation sessions will result in improved exercise     tolerance during sessions. This in turn will lead to an increased response to pulmonary     rehabilitation, resulting in improved exercise tolerance and quality of life.   "
84609|NCT02178553|"     Unilateral intercostal nerve blocks provide pain control as effectively as a continuous     thoracic epidural, and will a lower incidence of side effects.   "
84598|NCT02178696|"     Major depression is a highly prevalent, frequently debilitating illness that too often fails     to respond to currently available treatments such as antidepressant medication. Furthermore,     randomized controlled trials of antidepressants consistently demonstrate large placebo     effects. The investigators hypothesize that individual differences in the function of key     brain circuits underlie the observed variability in clinical responses to both placebo and     antidepressant medication. This study will test this hypothesis by recruiting     treatment-seeking volunteers with major depression, with or without comorbid nicotine     dependence. Volunteers will participate in positron emission tomography (PET) and functional     magnetic resonance imaging (fMRI) scans in the context of a treatment trial in which they     will receive both placebo and antidepressant medication. A major goal of the study is to     improve prediction of individual clinical responses in future treatment trials in which brain     imaging may be unavailable, and to study the mechanisms of antidepressant response in Major     Depression.   "
84599|NCT02178683|"     This protocol will evaluate Tacrolimus and MMF after conditioning with fludarabine and     low-dose TBI in patients who are not candidates for conventional allografting. A novel     approach to immunosuppression will be tested incorporating an early but extended taper of     Tacrolimus starting on day +80 or in the case of relapse. The goal is to induce early     immunity and GVT effects without compromising GVHD control. The anti-metabolite MMF will be     re-introduced on day +100 to try and induce tolerance and block chronic GVHD during the taper     of the Tacrolimus. DLI may be given in the presence of disease progression but not for mixed     chimerism as in previous protocols.   "
84600|NCT02178670|"     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors     into immunosuppressed mice, preventing an assessment on the immunologic interactions and     effects of CSCs. In this study, the investigators examined the vaccination effects produced     by CSC-enriched populations from histologically distinct murine tumors after their     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic     and more effective as an antigen source than unselected tumor cells in inducing protective     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor     immunity.   "
84601|NCT02178657|"     This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear     cells in acute ischemic stroke patients is safe and improves neurological outcomes.   "
84602|NCT02178644|"     This pilot study focuses on KD018 and will investigate the effect of this agent on reducing     the Gastrointestinal (GI) toxicity associated with combined modality therapy of     locally-advanced rectal cancer.   "
84603|NCT02178631|"     Online self-help is an innovative way of providing self-help. The investigators want to study     the effect of an interactive online self-help-program (Deprexis) in the treatment of severe     depressive symptoms. Participants will be randomised to either twelve weeks of online-self     help or a waiting-list control. Symptoms of depression and other aspects will be assessed     over a six months period. The investigators hypothesise that online self-help is superior to     the control condition in alleviating depressive symptoms and preventing full blown     depression.   "
84604|NCT02178618|"     Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been     used as a principle palliative method of distal biliary obstruction in patients with     pancreaticobiliary cancers. With potentially curative surgical resection being impossible,     the maintenance of successful biliary drainage through patent stent has been regarded as the     key to improve the quality of life and survival of patient, because it could prevent biliary     infection or liver failure, and give patients opportunities for anti-cancer chemotherapy     and/or radiotherapy.      Although SEMSs have been reported to be superior to large bore plastic stents in terms of     stent patency, they still have some controversial issues to resolve in relation to stent     dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to     overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant     higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not     show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs,     despite some clinical results of randomized trials favor to covered SEMSs.      From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting     results have been produced. It was initially assumed that covered SEMSs could cause the     higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct     and cystic duct by covering materials. However, no significant difference was found with     regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs     in several randomized trials and meta-analysis.      The aim of the current study is to compare the cumulative stent patency of partially covered     and uncovered SEMS as a primary objective, and investigate overall patient survival, stent     dysfunction-free patient survival, and incidence of adverse events including stent     dysfunction as secondary objectives.   "
90141|NCT02106182|"     The objective of this study is to determine safety and efficacy of silodosin, which is a     treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients     with benign prostatic hyperplasia accompanied by nocturia.   "
84605|NCT02178605|"     This prospective study will investigate the use of recombinant human bone morphogenetic     protein (rhBMP-2) in the current surgical standard of care for cervical spine pathology.     Specifically, the outcomes of three forms of cervical fusion will be investigated:        1. Anterior cervical fusion with rhBMP-2, allograft corticocancellous bone as an interbody          device, and anterior cervical plate fixation.        2. Posterior cervical fusion with rhBMP-2, local bone graft, with or without posterior          screw fixation.        3. A combination of the previous two approaches: a combined anterior-posterior cervical          fusion with rhBMP-2.   "
84606|NCT02178592|"     HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is     the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin     [RIF]) are an important component of TB therapy because of their unique activity. The problem     is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors     (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to     reduced concentrations of these agents with risk of treatment failure or resistance. The     non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the     same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients     concomitantly treated with RIF-containing TB therapy, demonstrating that their     co-administration can be used safely and effectively. However, the side effect profile of EFV     overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities     very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important     alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction     study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice     daily given together with RIF was well-tolerated and resulted in DTG concentrations similar     to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive     patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment     option for TB-infected patients who require concurrent treatment for HIV infection. This is a     Phase III b, randomized, open-label study describing the efficacy and safety of DTG and     EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess     the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A     total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG     (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study     will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week     extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be     supplied with DTG until it is locally approved and commercially available, the subject no     longer derives clinical benefit, or the subject meets a protocol-defined reason for     discontinuation, which ever comes first.   "
84612|NCT02178514|"     Our main research question is: Do infants fed with BabyNes Nutrition System grow in agreement     with the WHO reference?      Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic profile     closer to breastfed infants?      In order to answer both questions an observational trial will be carried out for 12 months in     order to measure weight and to calculate the weight for age z-scores according to the WHO     reference.      A breastfeeding group will be used as reference for the metabolic parameters measured in     blood of infants from Chinese background.      The effect of the Babynes formulas will be compared to the metabolic values obtained from     this breast-feeding reference group.   "
84613|NCT02178501|"     The major source of mortality and morbidity of diabetic patients is cardiovascular disease     (CVD). Moreover, in CVD patients the presence of diabetes is associated with the increased     risk of major adverse cardiac events as compared to patients without diabetes. The     pathophysiology of macrovascular complications in T2D is not fully understood and involves:     1/ induction of oxidative stress, 2/ the formation of advanced glycation end products, 3/     activation of blood coagulation and platelet aggregation, 4/ increased inflammation, 5/     altered secretion of adipokines in obese subjects and 6/ endothelial dysfunction. All those     mechanisms in T2D patients could potentially be a subject of new therapeutic interventions.      A therapy that continues to show promise in T2D patients with CVD is supplementation with     omega-3 polyunsaturated fatty acids (PUFA). Clinical studies have indicated that omega-3 PUFA     decrease the risk of major cardiovascular events, although the mechanism of action is not     completely understood. Moreover, there were no trials exploring the mechanisms and outcomes     of omega-3 treatment in T2D patients with CVD. Despite that fact, Polish Diabetes Association     guidelines recommend the use of omega-3 PUFA in patients with diabetes in the prevention of     macrovascular complications. Moreover, it is unclear whether the benefits of modifying the     pathophysiological processes during supplementation with omega-3 PUFA occur only in patients     with their deficiency or in all patients with type 2 diabetes.      Potential benefits of omega-3 PUFA in such patients are: 1/ decreased oxidative stress, 2/     decreased platelet aggregation and reduction of hypercoagulable state, 3/ anti-inflammatory     effects, 4/ improvement in endothelial function. All those effects were explored previously     with inconsistent findings. There is very limited information from clinical studies on the     mechanisms and benefits of omega-3 PUFA in T2D patients with CVD.      The objective of the current study is to evaluate the effects of omega-3 PUFA administered on     top of optimal therapy of atherosclerotic vascular disease and T2D on endothelial function,     platelet aggregation and thrombotic, inflammatory and oxidative stress biomarkers.   "
84614|NCT02178488|"     The purpose of this study is to treat persistent MRSA carriers with vitamin D supplementation     during a 12 month to see if the number of MRSA positive patients can be reduced.   "
84615|NCT02178475|"     Prospective observational study of febrile neutropenia (FN) and pegfilgrastim primary     prophylaxis in breast cancer and non-Hodgkin's lymphoma patients receiving high (>20%)     FN-risk chemotherapy   "
84616|NCT02178462|"     A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for     gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles     (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed     by multivariate statistical analyses. However, further studies to assess whether this     biomarker demonstrates the same performance characteristics in non-Japanese populations for     cancer is yet to be determined.   "
84617|NCT02178449|"     The main aim of the study is to investigate the proven effect of dexamethsone on the duration     of the interscalene block. The investigators try to define optimal dose and volume for     ropivacaine, when used together with dexamethsone. The current literature uses often very     high volumes of ropivacain when used together with dexamethasone. The investigators try to     research the effect of using dexamethsone together with low volume, high concentration     ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone     has an positive effect on the pain free after used together with ropivacaine at the scalene     block.   "
84618|NCT02178436|"     This partially randomized phase Ib/II trial studies the side effects and best dose of     selinexor when given together with gemcitabine hydrochloride and paclitaxel     albumin-stabilized nanoparticle formulation and to see how well they work in treating     patients with pancreatic cancer that has spread to other parts of the body. Drugs used in     chemotherapy, such as selinexor, gemcitabine hydrochloride and paclitaxel albumin-stabilized     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.   "
84619|NCT02178423|"     After the placement of a central venous catheter in children, a routine chest X-ray will be     performed in order to examine the correct position of the catheter. In this feasibility study     the investigators intend to evaluate whether the ultrasound is as sufficient as the chest     X-ray to verify the correct position of the central venous catheter in children with the     purpose to prevent radiation on children in the future.   "
84690|NCT02177487|"     Study to assess the safety of six month of open-label, treatment with the fixed dose     combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients     with mild-to-moderate hypertension who completed the eight week randomized, double blind     502.261 study.   "
84620|NCT02178410|"     The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,874     U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000     IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer,     heart disease, and stroke in individuals who do not have a prior history of these     illnesses.The purpose of this ancillary study is to ascertain and adjudicate atrial     fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or     vitamin D supplementation influence atrial fibrillation risk in the general population. We     also plan to examine how these agents might impact intermediate phenotypes for heart rhythm     disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death     and whether baseline blood levels and/or race modify treatment effects.   "
84621|NCT02178397|"     The current first line treatment of patients with EGFR activating mutation lung cancer is     EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of     response rate and progression-free survival. However, an acquired resistance occurs almost     constantly. The second-line treatment includes platinum-based chemotherapy in the absence of     contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.      However, a rebound phenomenon of the disease was described in patients who discontinued EGFR     TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any     withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI     acquired resistance.      It seems therefore useful to conduct a study to better define the therapeutic strategy to     adopt in patients developing an acquired resistance after having received EGFR TKIs as first     line treatment.   "
84681|NCT02177604|"     Previous research has shown that indulging in 50% more calories than required for as little     as 3 days can significantly impact markers of metabolic health in lean and overweight     individuals. Here, the investigators will determine if 3 brief sessions of high-intensity     interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in     sedentary, overweight males.   "
86618|NCT02152293|"     The purpose of this study is to assess, in real life, the efficacy and the eligibility for     discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short outpatient     surgery.   "
84622|NCT02178384|"     The two structures that support a mandibular distal extension removable partial denture     differ markedly in their visco-elastic response to loading. The difference between the     resilience of the residual ridge tissues and the teeth permitted by the periodontal ligament     presents a disparity of support that is in contrast to the uniform support accorded a     tooth-supported removable partial denture. Hence the denture tends to rotate about its most     distal abutments, inducing heavy torsional stresses on alveolar ridges.      Many methods have been used to control this movement, some of them:        1. Implant support on distal extension removable.        2. Stress breakers provide a mean of interposing a flexible connection between the          tooth-borne retainer portion of removable partial denture and its distally extended          tissue-borne segment.        3. Altered-cast technique.        4. Design development by using mesial indirect retainers rather than distal ones.      The purpose of this study is: (1) to compare bone absorption around abutment teeth nearby the     free saddle; (2) denture displacement and pressure on the soft tissue under the denture base     of distal extension RPD (Removable Partial Denture) (3) cellular changes in the soft tissue     under the denture base of distal extension RPD.   "
84623|NCT02178371|"     The purpose of this study is to assess the functionality of the affected upper limb in     infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.   "
84624|NCT02178358|"     The main purpose of this study is to evaluate the safety and effectiveness of the study drug     known as LY2157299 in participants with hepatocellular carcinoma.   "
84625|NCT02178345|"     Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of     the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses     faster imaging. It also includes a contrast material that is given by vein. This makes     specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the     motion of water in the tumor.      Perfusion and diffusion MRI give extra information which is not available with the regular     MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the     current standard of care. The purpose of this study is to see if new MRI methods can give us     more information about the tumor.   "
84626|NCT02178332|"     The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole     school programme is effective in improving children's socio-emotional skills and mental     health and socio-emotional skills.      All Finnish elementary schools and their classes in 1-3 grades were invited to participate in     the study. The schools were randomly allocated to receive either Yhteispeli programme or two     lectures   "
84627|NCT02178319|"     Many patients with portal hypertension require surgical treatment each year,and Hassab's     operation, or esophagogastric devascularization and splenectomy, is an elective procedure. In     recent years,laparoscopic esophagogastric devascularization and splenectomy has been used to     treat portal hypertension. However, the potential benefits remain to be demonstrated in the     context of a randomized trial. In this study, 120 patients will randomize equally receiving     laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion criteria     included: platelet count < 50×109/ml, esophageal and gastric varices revealed, agreeing the     informed consent. PerioperativeOutcomes are: technical success, blood loose and infusion     during the operation, recurrent varicose veins on gastroscopy examination, patterns of reflux     on duplex ultrasound examination, complications, platelet and liver function variation,     length of hospital stay. Follow-up will last 5 years, and gastroscopy and ultrasonic will     perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study was proved by the     ethical committee of second hospital of Xi'an jiaotong university.   "
84628|NCT02178306|"     To evaluate the safety and efficacy, in particular with regard to renal function of     telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to     endstage renal impairment after 12 weeks of treatment   "
84629|NCT02178293|"     A study to in order to verify any differences between the 2 treatment groups in terms of     duration of analgesic effects after the first drug intake and time to remission of symptoms     and signs of pharyngitis   "
84630|NCT02178280|"     Hilar cholangiocarcinoma is a highly malignant tumor. Surgical resection or simple liver     transplantation leads to poor prognosis accompanied by high recurrence rate and low survival     rate. The newly proposed neoadjuvant therapy with liver transplantation strategy shows     promising clinical application, which once reported 5-year survival rate 82%. However,     transplantation centers conducting this kind of research are limited due to its complexity     and long-term. The investigators would like to conduct a clinical trial for only unresectable     hilar cholangiocarcinoma patients who should take neoadjuvant brachytherapy and     chemoradiotherapy followed by orthotopic liver transplantation.   "
84631|NCT02178267|"     In this study, the investigators investigated the effect of probiotic use on colonization of     resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the     use of probiotics in preterm neonates in neonatal intensive care units expect to prevent     colonization by resistant microorganisms.   "
84632|NCT02178254|"     The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single     doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug,     Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to     dosing on Day 1 of Period 1 prior to study screening.   "
84633|NCT02178241|"     This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in     treating patients with bladder cancer that has spread to other places in the body or cannot     be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and     eribulin mesylate, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.   "
84634|NCT02178228|"     The purpose of this study is to identify the cause of leaks that sometimes occur after a     section of the bowel is removed and reconnected. Certain staplers from the operating room     will be collected and sent to a third party (ECRI Institute) to be examined for defects. The     patient's charts will be analyzed for medical issues that may contribute to leaks after     surgery.   "
84695|NCT02177422|"     The primary objective of this trial was to assess the efficacy and safety of telmisartan 80     mg during open-label, long-term treatment. An additional objective was to assess the efficacy     and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide)     and/or any other therapies commonly used in the treatment of hypertension.   "
84635|NCT02178215|"     Atopic dermatitis is a chronic intermittent inflammatory skin disease. Currently, there are     many cosmeceutical skin products in which their major action affects skin hydration and skin     barrier function. In addition, there are some herbal medication remedies used for the     treatment of skin diseases based on the knowledge of Thai traditional medicine. Patients with     pruritic rash symptoms who attended the Center of Applied Thai Traditional Medicine, Siriraj     Hospital, were prescribed the Holly Mangrove Shower Gel to use and on the follow-up     appointment showed significant improvement. Nevertheless, the knowledge of using this herbal     medication for treating pruritic skin rash so far has been categorized as folk wisdom and not     been confirmed by any clinical-trial study on its efficacy and mechanism of action.      Research teams chose Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl to act as     adjunctive for treating atopic dermatitis. Thus, for the purpose of studying the efficacy of     Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl in improving the skin barrier     function in atopic dermatitis.   "
84636|NCT02178202|"     The purpose of this study was to investigate the effects of HT compared with McK exercise on     pain and disability in patients with LBP.   "
84637|NCT02178189|"     Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early     caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy     to implement and could improve early outcomes for these high-risk infants. We will conduct a     preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for     methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and     estimates of whether high-calorie formula results in more normal patterns of weight loss and     gain, less severe NAS symptoms and shorter hospital stays.   "
84638|NCT02178176|"     The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is     controlled is decreasing over time. This project can have a significant public health impact     because we are refining and pilot testing a primary-care based intervention aimed at     improving patient engagement and function which are critical components of diabetes care and     are associated with improved glycemic control, lower disease-related health-care     expenditures, and reduced mortality.   "
84639|NCT02178163|"     This research trial studies comprehensive genomic analysis in tissue samples from patients     with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic     analysis may identify specific gene mutations (changes in deoxyribonucleic acid [DNA]) and     help doctors to tailor treatment to target the specific mutations.   "
84640|NCT02178150|"     This is a double-blind randomized clinical trial which will start at June 2014 and end on     June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample     size calculated 70 persons (35 persons for control group and 35 persons for patient group).     Patient group will receive magnesium supplement (250 milligram) and the other group will     receive placebo which is similar to the magnesium tablets in color, odor and appearance both     for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome     measurements including sex hormone levels, metabolic and inflammatory profiles will be     measured at the beginning and end of the study as well as anthropetric measurements.   "
84641|NCT02178137|"     There has been intensive search for a substance that can have disease-modifying activity for     osteoarthritis. A number of medications have been reported to be of benefit on slowing     progression of knee OA. This trial will be the first head to head comparison of these     medications.      Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically     using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall     physical and mental health. The knee X rays will be assessed on Kellgren and Lawrence grading     and will also be measured for joint space narrowing at follow up. The response to arthritis     medications on slowing down cartilage loss will be measured biochemically with COMP levels.   "
84642|NCT02178124|"     Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch     in healthy male subjects   "
84645|NCT02178085|"     Background : Glaucoma is a common disease, potentially blinding, characterized by progressive     damage to the optic nerve. If the intraocular pressure is the most known risk factor,     however, there are cases of glaucoma scalable despite well-controlled intraocular pressure,     ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension     glaucoma).      Purpose :Involvement of vascular factors in the development of glaucoma and scalability has     been proved, associated with a possible loss of vascular autoregulation. The objective of     this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma     untreated comparison with control subjects.   "
84646|NCT02178072|"     The purpose of this study is to assess the activity of 5-azacitidine in patients with Human     Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma     (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and     after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck     cancers or head and neck cancer cells cultured in laboratories suggest that treatment with     5-azacitidine increases changes in cancer cells that lead to their death. This study is     designed to determine if similar changes occur in cancer cells of patients with head and neck     cancer.      The study also aims to determine the amount of a specific type of protein, p53 before and     after treatment. Research has shown that the p53 protein is associated with anti-tumor     activity.      Finally, this study is measuring the amount of a specific type of protein called interferon     in your tumor tissue. Interferons are proteins made and released by the body in response to     pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons     allow for communication between cells to trigger the protective defenses of the immune system     that remove pathogens (disease causing agents) or tumors.   "
84647|NCT02178059|"     Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via     current version of Turbuhaler with inhalation via a new version   "
86626|NCT02152189|"     The purpose of this study is to assess the frequency of Fabry disease in children with     chronic abdominal pain or chronic pain in the extremities   "
84649|NCT02178033|"     An adequate level of bowel preparation is crucial for the efficacy and safety of colonoscopy.     Strong evidences suggest that bowel-preparation quality shows an inverse correlation with     length of the interval between the end of cleansing agent intake and the start of colonoscopy     (shorter intervals are associated with better preparation levels). Accordingly, the use of a     split-dose administration regimen has been demonstrated to significantly improve the quality     of preparation, besides patient acceptability, as compared with standard administration the     day before colonoscopy. All randomized controlled trials comparing split versus standard     preparations were primarily aimed at assessing the quality of colon cleansing, by means of     either validated or not-validated colon cleansing scales. The impact of a split dose regimen     on objective colonoscopy performance measures such as adenoma detection rate (ADR) has never     been specifically and prospectively evaluated.      The present study is aimed at evaluating whether the split-dose preparation regimen is     associated with an increase of adenoma detection.      For this purpose, asymptomatic subjects aged 50-69, undergoing screening colonoscopy for     positive immunologic fecal occult blood test are randomized in a 1:1 ratio to receive     low-volume (2L) PEG plus ascorbic acid solution either in a split-dose (study arm) or in a     full-dose regimen (control arm).      Treatments are allocated using a computer-generated, randomized code list. The treatment     allocation is concealed and is accomplished at the screening visit through non-research     personnel who is not involved in the study. To ensure masking, the endoscopists who perform     the colonoscopies are not involved in the randomization process and in the pre-procedure data     collection.      In this study the the primary outcome measure was the proportion of patients with at least     one adenoma (Adenoma Detection Rate) in each harm. Data on bowel cleansing, patient     compliance, tolerability and acceptability were also collected.      A sample size of at least 514 patients (257 in each arm) was calculated, by hypothesizing a     relative increase of 25% in the adenoma detection rate in the split dose preparation group,     assuming a 40% prevalence of one or more adenoma in FIT-positive patients undergoing     screening colonoscopy (significance level 0.05, 90% power).   "
84650|NCT02178020|"     Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing     total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced     to decrease this problem, but there is little data on the results and complications of this     polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following     questions: (1) Are there any differences in the clinical and radiographic results when a     highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of     reoperation in these two groups and are there any specific complications related to highly     cross-linked polyethylene liners.   "
84651|NCT02177994|"     A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in     elective cesarean section 30-60 min before skin incision versus after cord clamping.   "
84652|NCT02177981|"     Coronary artery disease (CAD) is the leading cause of death worldwide. Patients with severe     CAD are often treated with coronary artery bypass grafting (CABG). Novel treatment strategies     need to be pursued to respond to the continuous increase in the risk profile of contemporary     CABG patients. Surgical myocardial revascularization is commonly performed with the use of     cardiopulmonary bypass (CPB). Neurological impairment following CABG may take on the form of     a new-onset motor deficit or postoperative cognitive dysfunction. The former is rare, but     potentially devastating. Conversely, declines in attention, memory and fine motor skills can     frequently be documented.      Ischemic preconditioning is a phenomenon of an endogenous protective response to organ     ischemia, which is triggered by brief cycles of nonlethal ischemia and reperfusion in tissues     known to be more resistant to ischemic insults. In clinical practice remote ischemic     preconditioning (RIPC) is achieved by inflicting short periods of ischemia with intermittent     restitution of flow to the upper extremity. This intervention has been shown to be effective     in the reduction of myocardial injury in cardiac surgical patients. The hypothesis tested in     this research proposal is that RIPC will decrease the extent of postoperative neurological     injury following CABG.      In this research project, 70 patients scheduled for an elective CABG will be recruited at a     single center. They will be randomly allocated to either undergo RIPC (intervention arm) or a     sham procedure (control arm). Inflating a blood pressure cuff to 200 mmHg for 5 min will     induce RIPC, thereby inducing a brief period of ischemia. This will be followed by a 5-minute     arm reperfusion. In total, three cycles of arm ischemia and reperfusion will be induced in     this fashion.      All patients will undergo pre- and post-procedural magnetic resonance imaging (MRI) of the     brain, as well as neurocognitive testing. The array of MRI tools that will be used for the     quantification of brain injury will include fluid attenuated inversion recovery, diffusion     weighted and susceptibility weighted imaging, coupled with resting state functional MRI.      The investigators aim to determine whether RIPC can reduce the adverse impact of CPB on     neurological outcome as evaluated by MRI detectable brain ischemia and neurocognition.   "
84653|NCT02177968|"     The purpose of this study is to identify the prevalence and the characterization of health of     elderly fallers and non-fallers in the southeastern community of Brazil in the state of São     Paulo.   "
84654|NCT02177955|"     Objective: The aim of the present study was to compare hemodynamic changes using 7.5 mg of     midazolam and 10.0 mg of diazepam during the surgical removal of symmetrically positioned     third molars.      Study design: A prospective, randomized, double-blind, clinical trial was carried out     involving 120 patients divided in three groups: Group 1 (diazepam and placebo), Group 2     (midazolam and placebo) and Group 3 (diazepam and midazolam). Each subject underwent two     surgeries on separate occasions under local anesthesia.   "
84655|NCT02177942|"     The effect of supplementation using both protein and multiple micronutrients in preschool age     children on cognitive performance and growth is unknown. The study will compare the effect of     combination of protein and multiple micronutrients on indicators of cognitive performance and     growth in preschool age children. Cognitive performance and anthropometric assessments will     be measured at baseline and at 6 months.   "
84656|NCT02177929|"     The hypothesis is to the fulfillment of canoeing, handbike and conventional physiotherapy     activities the groups could show improvement in muscle strength of the arms, decreased     resistance of the lower limbs (spasticity), improved trunk balance and movements of the upper     limbs, improves cardiovascular function, bone health, and consequently improve the quality of     life.   "
84657|NCT02177916|"     The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the     quality and quantity of the education that is provided to patients listed for lung     transplantation. We propose to change the method and timing of our transplant patient     education. The objective of this prospective data collection will be to collect and analyze     pre and post test scores of patients when patient education is provided via compact disc as     compared to individualized teaching.   "
84658|NCT02177903|"     The application of active warming to patients whether awake or under general anesthesia has     been proven safe in numerous studies and it is common practice to use warmers. The warmers     are commonly used with both the supplied blankets and also with hospital blankets.      Subjects receiving standard care will not benefit from this study. Subjects in the     investigational group may benefit in several ways:        -  Increased comfort in the pre-operative period by being warmer        -  Decreased incidence of mild hypothermia        -  Possible decreased incidence of transfusion with less bleeding        -  Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)        -  Possible shorter stay in the PACU and overall Length of Stay (LOS)        -  Possible decreased risk for surgical site infection   "
84696|NCT02177409|"     The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering     ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing     interval in patients with mild-to-moderate hypertension as measured by ambulatory blood     pressure monitoring (ABPM)   "
84659|NCT02177890|"     Nausea is a common and distressing experience that often precedes vomiting. Amongst symptoms     emanating from the gastrointestinal (GI) tract nausea can be considered somewhat unique, as     on one hand it represents a normal, highly conserved, physiological response to an ingested     toxin yet on the other it may indicate pathology. Nausea may also arise as a consequence of     pharmaco- and chemotherapeutic interventions. Nausea negatively impacts on quality of life,     adherence to treatment and is a cause for discontinuation of the development of novel     compounds. Experimentally, nausea can be induced in humans using a visually induced motion     stimulus. Previously we have developed a 10-minute motion video of the landscape rotating as     seen from the perspective of a subject standing on Westminster Bridge, London. The tilted and     rotating view visual display makes the subject perceive that they are spinning round and     round on a spot tilted away from centre of gravity due to circular vection. This motion video     induced nausea in approximately 50% of healthy participants and caused a reduction in cardiac     vagal tone, a validated measure of the parasympathetic nervous system branch on the autonomic     nervous system. We therefore are evaluating the role of external transcutaneous vagal nerve     stimulation in visually induced motion sickness.   "
84660|NCT02177877|"     This study will assess whether a movement detecting wristwatch can accurately detect seizures     and seizure characteristics and record them into an online epilepsy diary. The patients may     manually record a description into the online epilepsy diary of the symptoms they experienced     before, during or after the seizure.   "
84661|NCT02177864|"     The investigators hypothesize that fiber supplementation will provide measurable differences     in indices of children's health (fewer complaints of abdominal pain and constipation, lower     body mass index) compared to placebo.   "
84662|NCT02177851|"     Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem     worldwide, especially in women of reproductive age and young children. Iron supplementation     is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron     bioavailability from different supplementation regimens and how to optimize bioavailability     in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg     body weight for 3 months is reported to be the most effective method to rapidly increase iron     stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe     supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing     that the splitting would increase iron bioavailability compared with one single high dose.     However, there is no scientific evidence for this assumption; to the contrary, results from a     recent study suggest that iron bioavailability from a second supplementation dose of iron     after a first supplementation dose of iron is impaired due to increased hepcidin levels. To     address this bioavailability issue, the present study will determine iron absorption from 120     mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg     iron per day administered for 3 consecutive days. The investigators hypothesize that the iron     bioavailability from the single daily dose will be lower than that from the 2 doses. By     measuring also hepcidin, this study will provide important insights on the iron     bioavailability from a single dose of iron and on the same amount iron split into two doses     (b.i.d. administration).   "
84663|NCT02177838|"     This pilot clinical trial studies cetuximab and radiation therapy in treating patients with     stage III-IV head and neck cancer. Monoclonal antibodies, such as cetuximab, may block tumor     growth in different ways by targeting certain cells. Radiation therapy uses high energy x     rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Giving cetuximab or cisplatin together with     radiation therapy may kill more tumor cells.   "
84664|NCT02177825|"     This phase II trial will test the hypothesis that inhibition of c-kit signalling pathways in     pediatric patients with Neurofibromatosis Type I(NF-1) and progressing plexiform neurofibroma     will result in objective reduction and/or inhibition of plexiform neurofibromas progression.      This will be a Phase II study of imatinib mesylate given orally. Patients with stable or     responding disease may receive the drug for a period not exceeding one year.   "
84665|NCT02177812|"     This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) and     regimen for the orally administered lysine specific demethylase 1 (LSD1) inhibitor     GSK2879552. The recommended dose and regimen will be selected based on the safety,     pharmacokinetic (PK), and pharmacodynamic (PD) profiles observed after the treatment of     subjects with relapsed/refractory AML. The study consists of two parts. Part 1 will identify     the maximum tolerated dose (MTD) and/or RP2D using a dose-escalation procedure. Dose     escalations will be guided by the Neuenschwander-continual reassessment method (N-CRM). PK/PD     expansion cohorts will also be included in Part 1 to characterize the range of biologically     effective doses by assessing PD markers and obtain additional PK data. Part 2 will explore     further the safety, tolerability, and clinical activity of GSK2879552 at the RP2D in subjects     with AML.   "
84666|NCT02177799|"     Acute gastroenteritis is a common cause of hospitalization in children with significant     socioeconomic burden on the health community, we will follow in this observational and     analytical study the admitted cases of acute gastroenteritis to the pediatric floor at the     Sheikh Ragheb Harb Hospital over a period of summer time to determine the causes, etiologies     and epidemiology of Age in a community hospital.   "
84667|NCT02177786|"     This study will evaluate the efficacy, safety, and tolerability of selonsertib (formerly     GS-4997) in participants with diabetic kidney disease (DKD). Participants will be randomized     with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or     matching placebo.   "
84668|NCT02177773|"     The primary objective of this study is to determine if Gallium-68 labeled DOTA-TOC will     result in the delineation of more lesions in patients with somatostatin receptor positive     malignancies than with conventional imaging.   "
84712|NCT02177201|"     Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or     adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of     super-hydration with 0.9% saline in children undergoing specifically elective     otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended     period of fasting that interrupts the perfusion in gut. Based on this knowledge, we     hypothesized that administration of supplemental fluid would reduce the incidence of     postoperative vomiting.   "
84713|NCT02177188|"     In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life Support     (ATLS) shock classification. The most often used clinical signs are heart rate (HR), arterial     blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and     temperature. However, some of these signs, such as hypotension and tachycardia, lack     specificity and sensitivity and do not occur early enough. Even with an early preload     reduction, blood pressure can remain constant due to compensatory mechanisms, such as     vasoconstriction and positive chronotropism. Tachycardia occurs earlier, but has poor     specificity and sensitivity. A retrospective analysis of 25,287 trauma patients showed that     among 489 patients presenting with systolic BP < 90 mmHg, only 65% had tachycardia (HR > 90     bpm), while 39% of patients with systolic BP > 120 mmHg were tachycardic, probably resulting     from other stimuli influencing heart rate, such as pain, fear, circulating hormones and     endogenous enkephalins. Therefore, it could be very useful to have an index that identifies     initial volume variation, when physiological regulatory mechanisms are still effectively     maintaining normal BP.      Pulse transit time (PTT) is the sum of pre-ejection period (PEP; the time interval between     the onset of ventricular depolarization and ventricular ejection) and vascular transit time     (VTT; the time it takes for the pulse wave to travel from the aortic valve to peripheral     arteries). PEP and VTT variations depend on preload variation, and PTT increases with PEP,     showing a linear correlation (R2 = 0.96). Chan et al. subjected 11 healthy volunteers to the     head-up tilt test, and demonstrated that PEP increased and VTT decreased for increasing tilt     angles from 0° to 80°, corresponding to light-moderate bleeding. They also observed early     sympathetic activation, expressed by decreases of both RR interval (RR) and VTT, dampening     the PTT increase, since PTT is influenced by both continuous PEP increase and progressive VTT     decrease occurring during hypovolaemia.      Here the investigators describe a new index, called indexed Heart to Arm Time (iHAT). iHAT is     the mPTT/RR ratio, where mPTT is a modified PTT, measured from the onset of ventricular     depolarization (the 'R' wave of the ECG trace) to the systolic peak of the     photoplethysmographic pulse oxymetry (PPG) waveform. mPTT is indexed to RR interval on ECG to     counteract sympathetic activation that would dampen PEP increase and enhance VTT reduction,     by means of positive inotropism and peripheral vasoconstriction, respectively. iHAT therefore     increases during haemorrhage because of preload reduction and the consequent PEP increase and     RR interval decrease. iHAT is expressed as the time percentage of the interbeat interval (RR)     it takes to the PPG waveform to travel to peripheral arteries. In this study iHAT has been     calculated as the average of beat-to-beat mPTT/RR ratios over 30 heart beats (corresponding     to at least 2 breathing cycles) in order to minimize the effect of spontaneous breathing on     preload, and thus on PEP and PTT.      In the present study, the investigators aimed to evaluate iHAT in a simulating model of     hypovolaemia by using a Lower Body Negative Pressure (LBNP) chamber. LBNP chamber simulates     haemorrhage by applying negative pressure to the lower limbs, thus giving an accurate model     of hypovolemia. The LBNP chamber has been used for many years for research purposes, and in     2001 Convertino suggested it is a useful device to test severe haemorrhage-related     hemodynamic responses. In fact, the induced volemic sequestration is an efficient technique     to study physiological behaviours in humans.      The primary endpoint was to evaluate the use of the iHAT as a predictor of hypovolaemia. The     secondary endpoint was to compare the specificity and sensitivity of the iHAT index compared     to commonly used indexes (BP, HR). Furthermore, the investigators aimed to assess feasibility     of Transthoracic echocardiography (TTE) evaluation of Cardiac Output (CO) in a haemorrhagic     model and to evaluate CO changes with respect to measured hemodynamic variables.      TTE evaluation of CO is non invasive and comparable to thermodilution, and of possible use in     an emergency setting.   "
84669|NCT02177760|"     Study Design: SCID infants receiving an unconditioned haploidentical transplant will be     started on Sirolimus (0.05 mg/kg/day) day -5 for Acute Graft-Versus-Host Disease (aGVHD)     prophylaxis. Sirolimus levels will be monitored with goal sirolimus trough level of 5-8     ng/mL. Patients will be monitored for signs of aGVHD as defined by UCSF SOP CL 221.06 through     day +100. Sirolimus will be tapered once T-regulatory cell to CD4 effector cell ratio is > or     = 9%.      Setting: Inpatient BMT Unit Benioff Children's Hospital at UCSF Medical Center      Study Subjects: 15 infants with diagnosis of maternally engrafted T cells SCID by CA Newborn     screen receiving unconditioned haploidentical HSCT      Main Outcome Measures: Incidence of aGVHD (dermatitis, hepatitis, enteritis) as defined by     SOP CL 221.06 by Day +100.      Hypothesis 1. Patients placed on sirolimus prophylaxis will have lower incidence of aGVHD     compared to historical controls.      Hypothesis 2. Lower doses of sirolimus milligram per kilogram will be required to maintain     goal troughs of 5-8 ng/mL.   "
84670|NCT02177747|"     A subset of 120 diabetic patients underwent dilated examination and smartphone     ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered     the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of     the retina.   "
84671|NCT02177734|"     The purpose of this study is to evaluate the safety and immunogenicity of different     formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.   "
84672|NCT02177721|"     This field study is designed such that it may be implemented for any individual who has been     administered raxibacumab for treatment of anthrax or for post exposure prophylaxis including     sporadic cases, small anthrax incidents and/or a mass event. This study is designed to     describe the clinical effectiveness (including course of illness and survival), safety     profile, and raxibacumab pharmacokinetics (PK) from patients who are treated with raxibacumab     as part of their clinical care following exposure to B. anthracis. Study data and samples for     PK and other investigational research will be collected prospectively to the extent possible     at pre-specified time points. However, because of the logistical complexities that would     likely accompany a mass anthrax event, most data in this study is anticipated to be collected     retrospectively. During such a mass anthrax event scavenged blood samples will be utilized     where possible to maximize sample analyses for PK and other investigational parameters.     Therefore, both retrospective and prospective data collection are allowed in this protocol in     order to maximize the amount of information obtained in subjects who have been administered     raxibacumab. This field study will be the first opportunity to collect data on B.     anthracis-exposed patients treated with raxibacumab, to better understand the clinical     benefit and safety of the drug and to further inform patient care and treatment choices for     management of anthrax   "
84673|NCT02177708|"     There is increasing evidence that the pathophysiology of hepatic encephalopathy (HE) is     tightly associated with low-grade cerebral edema. Uptake of ammonia in astrocytes leads to     osmotic swelling caused by glutamine formation. Previous studies were performed in covert HE     patients or used indirect methods.      Methods: The investigators wish to describes quantitative measurement of localized water     content using MRI water mapping in a cohort of patients with cirrhosis during an episode of     overt HE type C and again after recovery. Furthermore patients with cirrhosis and no history     of HE and healthy subjects will be investigated as controls.   "
84674|NCT02177695|"     The primary focus of this study is to see if looking at tumor biomarkers using a program     called coexpression extrapolation or COXEN may predict a patient's response to chemotherapy     before surgery.   "
84675|NCT02177682|"     Afuresertib, an AKT inhibitor, has shown in vitro and in vivo activity in multiple myeloma     models. AKT inhibitor has also demonstrated encouraging clinical activity in multiple     myeloma. This study is designed to determine the tolerability, safety, pharmacokinetics and     efficacy of afuresertib as monotherapy in Japanese relapsed multiple myeloma patients. This     is an open label, dose-escalating, phase I study. Afuresertib will be given daily until the     subjects meet any study treatment withdrawal criteria including disease progression. A total     of up to 24 subjects will be enrolled in the study.   "
84676|NCT02177669|"     The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial     vision and predicts functional vision better than visual acuity, but long testing times     prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. (2010)     developed the qCSF method to obtain precise CSF measurements in only 30-50 trials using a     computerized software program that presents letters on a large monitor that are identified by     a patient similar to typical visual acuity testing with an eye chart. The quick CSF method is     a Bayesian adaptive method that estimates the full shape of the CSF, and the test duration is     only about 3-6 minutes. Some preliminary testing has been performed at other sites with this     test in patients with vision loss due to amblyopia and glaucoma, but data from individuals     without eye disease who have normal visual acuity has not been systematically collected with     the latest version of this test procedure across a wide range of ages. In addition, we aim to     gain a better understanding of the typical test-retest variability that is obtained     between-sessions that are about a week apart from individuals with good ocular health and     visual acuity.   "
84677|NCT02177656|"     This study will test the effectiveness of motivational interviewing and skill building     compared to usual care to improve self-care in heart failure (HF) patients. The target     population is HF patients recruited from the Hospital of the University of Pennsylvania after     an in-patient admission. Patients in the intervention arms will receive one home-visit from a     nurse who does a self-care intervention followed up by 3 follow-up phone calls.   "
84678|NCT02177643|"     Considering that, Diacerein is on the market for almost 20 years, being used continuously in     elderly patients with osteoarthritis without present significant side effects, and     considering the anti-hyperglycemic effect and the improvement in the insulin resistance     observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim     of our study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic     properties and moderately analgesic activity, anti-inflammatory and antipyretic, which     demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as     interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic     control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.   "
84682|NCT02177591|"     The prevalence of cardiovascular disease is rising; new methods must be created to assess the     cardiovascular status of patients. If cardiovascular disease can be predicted, it may     facilitate prevention. An association between periodontal disease and cardiovascular has been     established, but a definitive mechanism is not understood. A good first step in finding that     mechanism is to look at the correlation between periodontal disease and cardiovascular     disease, both of which have an inflammatory component. This study observes the level of     cardiovascular disease in patients and correlates it with the presence and degree of     periodontal pathogens.   "
84683|NCT02177578|"     In this study patients will be treated with 6 weeks of radiation therapy plus temozolomide     chemotherapy according to the standard of care. However, the radiation treatment plan will be     modified to deliver an higher than routine radiation dose to the subventricular zone which is     an area of the brain that contains stem cells that some scientists believe may contribute to     glioblastoma recurrence. The purpose of the study is to see if the tumor is controlled for a     longer period of time in patients treated with this modified radiation technique than it is     in patients treated with standard radiation therapy plus temozolomide chemotherapy.   "
84684|NCT02177565|"     Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.   "
84685|NCT02177552|"     The main purpose of this study is to determine the effects of treatment with carboplatin,     docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.   "
84686|NCT02177539|"     The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate     + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply     cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)   "
84687|NCT02177526|"     Management of prostatic carcinoma varies according to stage of disease. Trans-rectal     ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling     and random non-targeted technique. Methods to improve pre-operative tumor localization and     grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area     of research but requires further validation.      High grade tumors can undergo comedo-type necrosis with malignant calcifications which only     occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using     computed tomography (CT) and/or MRI.      Detection of malignant calcification within tumor foci will improve the accuracy of     localization and grading in prostatic carcinoma.   "
84688|NCT02177513|"     Background:      - Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions,     attention, and behavior after they take marijuana in different ways. They want to learn     better ways to detect drugs in a person s body They also want to know how long marijuana can     be found in blood, urine, saliva, and breath.      Objectives:      - To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component)     and how their bodies handle it after it is given in different ways.      Eligibility:      - Adults age 18 50 who use marijuana.      Design:        -  Participants are screened under another NIDA protocol.        -  This study involves up to 6 visits to NIDA.        -  At the first visit, participants will practice the tasks and tests they will do at their          dosing sessions. They will learn how to give breath and saliva samples.        -  Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a          research clinic the night before these sessions. Some participants can stay at the          clinic and some must go home between sessions.        -  At each session, participants will eat a brownie with placebo or marijuana. Then they          will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after          it is vaporized.        -  Throughout the sessions:        -  Participants will give urine, saliva, and breath samples. Their blood will be taken with          a tube in a vein and finger pricks. Their vital signs will be checked.        -  Participants will answer questionnaires and take thinking tests. They will also take          tests that assess eye movement, balance, and time estimation.        -  Participants may have a 5th dosing session. They will eat a marijuana brownie and have          the above tests and samples.   "
84691|NCT02177474|"     In a randomized controlled trial the investigators intended to evaluate the effect of a     telephone based peer support intervention on depressed or anxious women with coronary heart     disease (CHD). The investigators intended to include 198 depressed or anxious women aged over     18 years with CHD. Participants were randomized to intervention (IG) or waiting list (WL). IG     was offered immediate telephone-based contact to peer counselors while WL received the offer     with a 6-month delay. All participants got at least one telephone call by a clinical     psychologist (study information, feedback about the individual level of distress, proposal to     get help). Main outcome variables were depressive symptoms (PHQ-9) and perceived social     support (F-SozU K-14). In an additional quasi-experimental trial, the investigators included     11 peer counselors and 11 matched controls not taking part in the intervention. Main outcome     variables were mood states (POMS) and perceived social support (F-SozU K-14).   "
84692|NCT02177461|"     Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared     with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.   "
84693|NCT02177448|"     The efficacy and safety of Telmisartan capsule in patients with essential hypertension were     evaluated in comparison with Enalapril Maleate in the double blind trial.   "
84694|NCT02177435|"     Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus     hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80)     alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated     trough diastolic blood pressure (DBP) after eight weeks of treatment.   "
84714|NCT02177175|"     The purpose of this study is to find out the effects, good and/or bad, of a beta blocker     (carvedilol) on heart function during treatment with anti-HER2 medication(s) including     trastuzumab (Herceptin).   "
84697|NCT02177396|"     The primary aim of the trial was to compare the effect of telmisartan and valsartan in     lowering ambulatory diastolic and/or systolic blood pressure in the last six hours of the     dosing interval. Secondary variables included changes from baseline in diastolic and systolic     blood pressures during other times during the 24-hour ABPM profile, changes from baseline in     seated trough diastolic and systolic blood pressures as measured by manual cuff, and     responder rates. Assessment of safety was also considered. Adverse events and use of     concomitant therapies were monitored at each study visit. Blood pressure and heart rate were     collected at each visit. Physical examination, electrocardiograms (ECG) and laboratory tests     were completed during the trial as well.   "
84698|NCT02177383|"     There are conflicting evidences of the effects of dietary supplementation with     polyunsaturated fatty acids (PUFAs) on athletic performance. The investigators working     hypothesis is based on the polyunsaturated fatty acids, given its pro-oxidative character and     also by its action on transcription factors can modulate the antioxidant response and     oxidative damage induced by physical activity.The overall objective of the study is to     establish situations improving athletic performance and study the oxidative balance by     manipulation of feeding patterns and consumption of nutritional supplements and investigate     the involved mechanisms.   "
84699|NCT02177370|"     The aim of the study was to compare the effect of fenoterol metered dose inhaler with     disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population as     well as on the clinical findings in patients with bronchial asthma over a two-week period of     treatment.   "
84700|NCT02177357|"     The objectives of this study were to evaluate the efficacy, safety, and tolerability of     pramipexole, as single-agent therapy or in combination with levodopa, in patients with     Parkinson disease living in Hong Kong and Taiwan.   "
84701|NCT02177344|"     The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of     ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical     comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol     (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary     disease (COPD). The efficacy and safety profiles of the two doses administered via the     RESPIMAT device will also be compared to their respective placebo groups   "
84702|NCT02177331|"     In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to     provide long-term data on its impact on liver function, glucose homoeostasis and lipid     metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be     studied.   "
84703|NCT02177318|"     To collect post-marketing safety and effectiveness information on the use of Tiotropium     Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily     clinical settings   "
84704|NCT02177305|"     Safety and tolerability after ocular administration   "
84705|NCT02177292|"     The purpose of this study is to find out the effects (good and bad) of using newer     technologies that allow very precise delivery of radiation. These newer technologies are     Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).   "
84706|NCT02177279|"     There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran     are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It     is still not clear exactly why this happens, but it is likely that the compounds which enter     our bodies when we eat such products are responsible. In this study we plan to find out what     these compounds are and where they are found. The investigators will do this by asking     volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood,     urine and stool samples over the next twenty-four hours. Once the investigators know how much     and which compounds are present, we can then find out possible reasons why they are     protective, for example by looking to see whether they are anti-inflammatory. We also plan to     look at whether if having a diet which contains either a lot of wheat-bran products or very     low amounts of these foods effects how they are absorbed by the body.      HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are     metabolized to compounds responsible for high cellular bioactivity imparting important health     benefits.   "
84740|NCT02176837|"     The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the     reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral     aneurysm.   "
90768|NCT02098018|"     There are many ways to reduce stress. This study will compare 2 different programs for     reducing stress. In addition to looking at how well the programs reduce stress, we will also     ask questions about how these programs may be working.   "
84707|NCT02177266|"     The study will determine the benefit of Colchicine versus placebo for cardiac surgery     patients on the post-operative development of atrial fibrillation and post-pericardiotomy     syndrome.      Primary Objective. Colchicine will reduce the composite endpoint of incidence of     post-operative atrial fibrillation and post-pericardiotomy syndrome at 3 months following     cardiac surgery.      Secondary Objectives.        1. Colchicine will reduce the incidence of constrictive physiology on echocardiography at 3          months following cardiac surgery.        2. Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3          months following cardiac surgery with the use of colchicine.   "
84708|NCT02177253|"     The primary objective of this study was to compare the long-term (12-week) bronchodilator     efficacy and safety of ipratropium bromide / salbutamol combination administered by the     Respimat® 40 mcg / 200 mcg (one inhalation q.i.d.) to COMBIVENT Inhalation Aerosol (two     inhalations q.i.d.), ipratropium bromide Respimat® (one inhalation q.i.d.) and Placebo     formulations of each in patients with Chronic Obstructive Pulmonary Disease (COPD). An     additional objective was to show the superiority of Combivent Respimat as compared to     ipratropium bromide (40 mcg) Respimat. Steady state pharmacokinetics over one dosing interval     following four weeks of therapy were also characterized.   "
84709|NCT02177240|"     The purpose of this study is to determine if the Flex-it® Articulating Stylet or the     GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult     GlideScope® intubations.   "
84710|NCT02177227|"     The purpose of our study is to determine, using a prospective, randomized-controlled trial,     the economic viability and clinical outcomes associated with patient-specific instrumentation     (PSI) for total knee arthroplasty in an obese patient population.   "
84711|NCT02177214|"     Purpose of the study is the visualization of the mesh and the determination of the mesh     surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh     visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to     visualize the mesh position in vivo in a safe manner. This provides long-term benefit to     early recognize possible recurrence caused by shifting or shrinking of the mesh and to     provide early treatment.   "
84715|NCT02177162|"     Physiotherapists' knee OA care is suboptimal. Exercise therapy including a combination of     aerobic, muscle strengthening and functional exercises is not always performed and a lot of     treatments are used for which there is no evidence. By a continuing education session and a     pop-up in the electronic patient file, this study wants to improve knee OA care by focusing     on combined exercise therapy.      The study will be performed in collaboration with Pro-Q-Kine, an independent organization     implementing quality improvement in Belgian physiotherapists' care. Besides Pro-Q-Kine the     study will be performed in collaboration with two or three software producers of     physiotherapists' electronic patient files that reached a national homologation for their     respective software packages and covering a large part of the Flemish physiotherapists.      Pro-Q-Kine will organize sessions of continuing education with a focus on optimal knee OA     care. These sessions will be performed in LOK-groups (local peer-groups of physiotherapists     who meet each other for continuing education). At these sessions the physiotherapists will be     asked to take part to the study. A pop-up will be installed in the electronic patient file of     the participating physiotherapists, lightening up when physiotherapists register a patient     with knee OA. The pop-up includes a short message about optimal knee OA care. The     physiotherapists will also receive a script for a query in their electronic patient files in     order to extract those patients that initiated a treatment for knee OA between 1 year and 3     months before the therapists received education. These patients will receive a letter of     their respective physiotherapists in which they are addressed to take part to the study. An     informed consent, patient questionnaire and retour-envelope will be included. There will also     be the opportunity to complete the questionnaire electronically with an electronic informed     consent. The patient questionnaire will include some background details (such as age and     gender) and details about the physiotherapeutic treatments they received for knee OA. The     patient questionnaire will be coded with a number, referring to the physiotherapist and to     the individual patient (the first patient of the first physiotherapist will be coded as 1.01,     the 10th patient of the 14th physiotherapist will be coded as 14.10). Patients' names will     not be revealed to the investigators and physiotherapists will not have any access to the     completed patients' questionnaires. The general practitioners in the environment of the     physiotherapist will (probably) receive a letter from the researchers. This letter will     contain information about the importance of referral to a physiotherapist in knee OA care and     about knee OA care in general. This letter will also refer to the study that is going on in     physiotherapists' care, without details.      Six months after the installation of the pop-up, the physiotherapists will be asked again to     perform the query to extract patients out of the electronic patient file that have been     treated for knee OA and whose treatment sessions had been started in the period of three     months from the installation of the pop-up.   "
84716|NCT02177149|"     The central hypothesis is that the use of a DBS (Deep Brain Stimulation) clinical decision     support system for individual patient management will enable considerable time savings     compared to standard care. This hypothesis was formulated from pilot studies that showed     dramatic decreases in DBS programming time compared to standard care for clinicians who used     an iPad-based decision support system (99% time savings from over 4 hours to 2 minutes. Study     group Parkinson's patients with DBS Systems   "
84717|NCT02177136|"     This is a phase 2, double-blind, placebo controlled trial in patients with primary sclerosing     cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular,     serum alkaline phosphatase; and, safety.   "
84718|NCT02177123|"     The purpose of this study is to collect additional safety and effectiveness data on the     InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who     are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥     18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.   "
84719|NCT02177110|"     This is an exploratory prospective translational multicentre study. Melanoma is the 5th most     common cancer diagnosed in Ireland and its incidence among women and men is above the     European average.      Following treatment the elimination of cancer cells ultimately occurs by the activation of     apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical     systems of modelling, quantitative biochemistry and cell biology, and specifically predicts     the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.      The investigators propose to validate the SYS-ACT approach and application in a translational     systems medicine study.   "
84720|NCT02177097|"     Revision surgery after total hip or knee arthroplasty is an ongoing issue due to an     increasing number of primary surgeries. Patients seek physicians due to pain. The cause is     divided between loosening, infection or chronic pain. Some are operated on the suspicion of a     chronic infection. However, postoperative microbiological testing does not always correlate     with the suspicion and the operation may have been superfluous.      The objective is to employ a highly advanced diagnostic algorithm based on state of the art     diagnostic techniques in order to improve the basis of preoperative diagnosis. Through this     approach treatment can be given according to the causal problem.   "
84721|NCT02177084|"     The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS)     associated with conservative therapy (arm A) for the treatment of low anterior resection     syndrome (LARS) compared with only conservative therapy (arm B).      The secondary aims are the evaluation of the following parameters:        -  Effect of PTNS on manometric parameters        -  Effect of PTNS on quality of life        -  Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation        -  Safety of PTNS   "
90769|NCT02098005|"     Chronic spinal pain (CSP) includes chronic low back pain, failed back surgery, chronic     whiplash associated disorders, chronic non-traumatic neck pain, etc. The current     investigators and others have provided evidence for impaired motor control of spinal muscles     in patients with CSP. In addition, there is increasing evidence that central mechanisms, i.e.     hyperexcitability of the central nervous system and brain abnormalities (e.g. decreased brain     matter density) play a role in CSP. Hence, treatments for CSP should not only address the     spinal muscles and joints, but also the brain. Therefore, a modern neuroscience approach,     comprising of pain neuroscience education followed by cognition-targeted motor control     training, can be applied.      The scientific objective entails examining the effectiveness of the modern neuroscience     approach vs. usual care evidence-based physiotherapy for reducing pain and improving     functioning in Flemish patients with CSP. A secondary objective entails examining the     effectiveness of the modern neuroscience approach vs. usual care evidence-based physiotherapy     for altering brain's structure and function (magnetic Resonance Imaging) in Flemish patients     with CSP. Therefore, a multi-center triple-blind randomized controlled trial will be     conducted.      To comply with this scientific objective, 120 CSP patients will be recruited and subjected to     the baseline assessment. The baseline assessment includes the assessment of pain (including     symptoms of central sensitization and conditioned pain modulation), the assessment of     restrictions in functioning, brain imaging, the evaluation of motor control and muscle     properties, spinal mobility, and psychosocial correlates. Baseline analysis will provide     descriptive statistics and will lead to calculate correlation between the different outcome     measures and predictors of pain and dysfunctioning. In a next step, included patients will be     randomized to the experimental or control group. Those in the experimental group will receive     neuroscience education combined with cognition-targeted motor control training. Those in the     control group will be subjected to a control intervention, including back/neck school and     general exercises. After the neuroscience education has been given, the experimental subjects     will fill in the neurophysiology of pain test. Several follow-up assessments will take place.     Part of the assessment (functionality (PDI questionnaire) and psychosocial correlates (Pain     Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ), Tampa Scale     for Kinesiophobia (TSK), Illness Perception Questionnaire revised (IPQ-R)) will be     re-evaluated after the first 3 sessions. The complete 'baseline' assessment will be repeated     in the month following the treatment complement, rounding up the short-term follow-up     assessment. Six months after the baseline assessment, pain, functioning and psychological     correlates are assessed in an intermediate online assessment. One year after baseline     assessment the complete assessment is repeated for the last time, unless the intermediate     assessment indicates that treatment effects are no longer present. Both short and long term     treatment effects can be studied and predictors for therapy success can be unraveled. Also     correlations between changes in different outcome measures can provide relevant and     innovative information.      The proof of principal suggests a strong effect reported by large effect sizes for pain and     disability compared to usual care.   "
84722|NCT02177071|"     Phase IV      Design : Prospective, open-label, randomized three-arms study      Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at     least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1     year      Primary objective To demonstrate that Infliximab scheduled maintenance with or without     antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free     remission over 2 years, while the latter is non inferior with regards to the mean time spent     in remission over the same duration      Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2     years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.      Number of subjects 300 randomized patients (100 per arm)      Study duration: 2 + 2 years Enrollment: 2 years + 1 year Follow-up: 2 years   "
84723|NCT02177058|"     This project directly addresses the national imperative for innovative strategies to improve     care for Medicare beneficiaries and reduce health care costs. The overall objective of the     proposed project is to improve the care of older individuals who reside in nursing homes     (NHs), and at the same time reduce unnecessary Medicare expenditures. This goal will be     accomplished by testing a quality improvement program designed to reduce the number of     avoidable hospitalizations of NH residents in a randomized controlled trial.      The primary hypotheses to be tested are:      Hypothesis1: Interventions to Reduce Acute Care Transfers (INTERACT) implementation NHs will     have a greater reduction in hospitalization rate than the control and monitoring only NHs     during the 12-month implementation compared to a 12-month baseline period.      Hypothesis 2: Reductions in Medicare expenditures for hospitalizations in the INTERACT     implementation NHs will be greater than the estimated costs of implementing the intervention.      Hypothesis 3: The effects of INTERACT on hospitalization rates will be greater among patients     on the Medicare skilled benefit for post-acute care, than for long-stay patients.      Hypothesis 4: The effects of INTERACT on hospitalization rates will be greatest among those     NHs with higher vs. lower intensity (fidelity) of implementing the program.      Hypothesis 5: There will be a greater reduction in measures of hospitalizations for     conditions defined as potentially preventable than for other transfers and     hospitalizations.      Hypothesis 6: Implementation of INTERACT will not be associated with worsening of relevant     quality measures in the participating NHs.   "
84724|NCT02177045|"     Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce     the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging     method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles     contrast media allows the diagnosis of vascularization of the lesion, according to timing.     Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most     likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis.     Females over 18 years age, with a focal lesion in breast will be suitable to perform this     examination.   "
84725|NCT02177032|"     Demonstrate non-inferiority of the immune response between new versus the currently     recommended intradermal regimens of rabies vaccine when administered with or without rabies     immunoglobulins in healthy subjects ≥ 1 years of age.   "
84726|NCT02177019|"     The research project is a component of a mentored research career enhancement award. The     purpose of the award is to help the PI and his collaborators prepare for future research     grant opportunities through the Patient Centered Outcomes Research Institute (PCORI). The     research project is a feasibility study with the following specific aims; 1) to assess     outcomes associated with a personalized health plan for frequent headaches; 2) to identify     measurable outcomes that are meaningful to patients with frequent headaches; and 3) to create     a patient stakeholder group to inform patient-centered outcomes research for frequent     headaches. Specific Aim #1 will be achieved by recruiting and enrolling 40 established     patients at the Duke Family Medicine Center who have frequent headaches. The intervention     consists of 3 study visits with the PI, 2 clinical consultations with subjects' established     primary care provider at the Duke Pickens Family Medicine Center, and participation in 2     focus groups. Personalized health plans might consist of a combination of medical management,     lifestyle changes, nutrition counseling, or other therapeutic modalities as appropriate. Data     analysis will be descriptive; no formal hypotheses will be tested.   "
84727|NCT02177006|"     Childhood exposure to high levels of sunlight is a strong determinant of melanoma risk.     Pediatric clinicians can provide important sun protection counseling. In 2003, the United     States Preventive Services Task Force determined that clinician counseling has an effect on     use of sunscreen for children but not for other sun protection measures such as protective     clothing, or reducing sun exposure. Regular sunscreen use prevents melanoma development in     adults as well as nevi in children, but reliance on sunscreen as the only form of sun     protection is problematic.      This novel research seeks to develop a sun protection program that is feasible for pediatric     clinicians to deliver with patient-centered messages and systems to support program     implementation in the clinical offices. The sun protection messages will enable behavioral     change by the stakeholders (caregivers and children) that will reduce painful sunburns in the     children and eventually reduce the incidence of melanoma. Testing the feasibility of     delivering the intervention in a pediatric practice will enhance the sustainability of the     intervention, and lead the way to dissemination of good practice.      This proposal seeks to develop and test an intervention that seeks to improve sun protection     of young children. The intervention includes two phases:      Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection     provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory     guidance sheet provided by the practice to caregivers of children 2-6 years of age.      Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported     surveys      We hypothesize that redemption of the vouchers will be associated with the perception of the     child having sun sensitive skin.   "
84741|NCT02176824|"     Chronotherapy is a term that describes therapeutic alterations of sleep wake cycles.     Different variations of sleep deprivation, set sleep wake schedules, and types of light     therapy have demonstrated efficacy in rapidly treating depression, and suicidal thinking.     This study seeks to explore the effect of two different chronotherapuetic protocols on     acutely depressed and suicidal inpatients admitted to the Medical University of South     Carolina   "
90807|NCT02097511|"     This is a randomized, open-label, single & multiple-dose, three-sequence, three-period     crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of     metoprolol tartrate in healthy male volunteers   "
84728|NCT02176993|"     The investigators goal is to improve the outcome of patients with acute stroke by inducing     mild cerebral hypothermia through surface cooling at the cervical and shoulder regions using     EMCOOLS Brain.Pads®.      For this project, the investigators can build further on their research group's experience     with hypothermia in animal models and invasive cooling in stroke patients.      The COOL program will prospectively evaluate safety, feasibility, patient acceptance and     efficacy of mild cerebral hypothermia using EMCOOLS Brain.Pads® in a large cohort of patients     presenting with acute stroke at the Emergency Department of the Universitair Ziekenhuis     Brussel. The application of EMCOOLS Brain.Pads® will be compared to routine clinical practice     in a randomized controlled trial. If proven to be safe, feasible, well-tolerated and     efficacious in the inhospital setting, future use in prehospital acute stroke care will be     incorporated with telemedicine support, as part of the Prehospital Stroke Study at the     Universitair ziekenhuis Brussel (PreSSUB).   "
84729|NCT02176980|"     Subjects are being asked to take part in a research study to test two levels of alcohol     services for patients with hepatitis C virus (HCV) who drink alcohol. The two levels differ     in intensity of alcohol services and in whether or not they include a focus on liver health.     The study will look at which level of alcohol services best decreases alcohol use among     patients with HCV.   "
84730|NCT02176967|"     This phase III trial studies how well response and biology-based risk factor-guided therapy     works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may     not need treatment until it progresses. In this case, observation may be sufficient.     Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and     what the best treatment is. Response and biology-based risk factor-guided therapy may be     effective in treating patients with non-high risk neuroblastoma and may help to avoid some of     the risks and side effects related to standard treatment.   "
84731|NCT02176954|"     The aim of this study is to investigate the influence of the adhesive wafer design on the     products ability to fit to the body..   "
84746|NCT02176746|"     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors     into immunosuppressed mice, preventing an assessment on the immunologic interactions and     effects of CSCs. In this study, the investigators examined the vaccination effects produced     by CSC-enriched populations from histologically distinct murine tumors after their     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic     and more effective as an antigen source than unselected tumor cells in inducing protective     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed     antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor     immunity.   "
84732|NCT02176941|"     The prevailing view in telomere epidemiology is that leukocyte telomere length (LTL) is     associated with atherosclerosis and accelerated aging since it serves as a biomarker of the     cumulative burden of inflammation and oxidative stress during adult life. Our recent results     however, indicate that telomere length (TL) is mainly determined at birth and childhood.     Since short telomeres ante cede atherosclerosis, the investigators hypothesize that TL is not     just a simple marker, but a real determinant of arterial aging. That is because TL reflects     cellular repair capacity and a short LTL denotes diminished repair reserves. This hypothesis     cannot be tested by measurements of LTL alone, since this parameter reflects TL at birth and     its age-dependent attrition thereafter. The investigators propose, therefore, a model that     makes it possible to examine different elements of TL dynamics in different tissues:     leukocytes, skeletal muscle, endothelial progenitor cells (EPCs), skin or subcutaneous fat in     patients with or without atherosclerosis.      Our model is based on the following premises, which are derived from observations that TL is     synchronized (equivalent) across somatic tissues/cells of the newborn:        -  TL in skeletal muscle mainly reflects TL at birth        -  The difference in TL between muscle and leukocytes in adults (approximately 1.5 Kbp)          mainly reflects LTL attrition during the growth period, i.e., childhood/adolescence        -  TL in EPCs determines the cell proliferative ability and therefore capacity for vessels          repair during aging.      The general aim of the present project is to examine the links of arterial aging with TL, as     expressed in different tissues, and LTL dynamics, as expressed in the difference between TLs     of muscle and leukocytes.   "
84733|NCT02176928|"     The purpose of this study is to examine impact of Sleep Disordered Breathing (SDB) treatment     in persons with chronic Spinal Cord Injury (SCI). The central hypothesis is that the     treatment of SDB with Positive Airway Pressure (PAP) will improve cognition, sleep quality,     health related quality of life (HRQOL), pain and Cardiovascular Disease (CVD) surrogate     measures in persons with chronic SCI.   "
84734|NCT02176915|"     The Fresh Start postpartum weight loss program will test the effectiveness of a group-based     weight loss intervention that includes videos featuring peers who have successfully achieved     postpartum weight loss. The group-based condition will be compared to a control condition     involving print materials related to weight loss.   "
84735|NCT02176902|"     This randomized phase II trial will evaluate if a low-fat diet with fish oil has the     potential to delay disease progression in patients with prostate cancer undergoing active     surveillance.   "
84736|NCT02176889|"     The purpose of this study is to determine whether Lactospore is safe in healthy adults.   "
84737|NCT02176876|"     This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple     infusions of GS-5745 in adults with rheumatoid arthritis (RA). Participants will be     randomized in a 4:1 ratio to receive 1 intravenous (IV) infusion of GS-5745 or placebo every     2 weeks, for a total of 3 IV infusions.   "
84738|NCT02176863|"     This is a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel     group clinical trial with adaptive dose selection in subjects with post polio syndrome (PPS).      The main purpose of this study is to select a dose of Flebogamma 5% DIF and confirm the     efficacy of the selected Flebogamma 5% DIF dose by assessing physical performance, as     measured by 2 Minutes Walk Distance (2MWD) test.   "
84739|NCT02176850|"     This post-marketing surveillance study was designed to supplement under conditions of normal     clinical practice the data on the safety, tolerability and efficacy of Micardis® collected     during the clinical studies.   "
84742|NCT02176811|"     The study searched for answers to two questions:      1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease     and healthy controls.      2. Is there any relationship between plasma betatropin levels and different stage of     non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin     levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.   "
84743|NCT02176785|"     Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation     technology that has demonstrated the ability to temporarily increase or decrease activity in     specific regions of the brain. The researchers are investigating the effect of this     technology on sleep propensity by applying two different types of stimulation as well as sham     (Placebo) stimulation during three different afternoon naps. The researchers are subsequently     hoping to recruit healthy volunteers without medical, or sleep problems who have a regular     sleep schedule to participate in the study   "
84744|NCT02176772|"     Background: The disease burden of tuberculosis (TB), second only to HIV/AIDS among infectious     diseases, is a major public health problem in developing countries. Accumulating evidence     suggests that iron status is a primary determinant of TB progression. Anaemia is prevalent in     patients with TB, particularly in sub-Saharan Africa, and associated with increased     mortality. Anaemia in TB may be due to inflammation, dietary iron deficiency, or both, and     distinguishing among these aetiologies is difficult. Iron supplementation is commonly used to     treat anaemia in TB patients, but may be unnecessary if inflammation is the cause. Body iron     sequestered by TB inflammation can be mobilized during treatment and used to correct the     anaemia. Moreover, supplemental iron may be retained within macrophages, potentially     increasing susceptibility to TB and leading to a poorer clinical outcome. Thus, better     understanding of iron metabolism during TB and the aetiology of TB-related anaemia would     clarify the potential role of iron in pathogenesis and optimal management of the disease.      The investigators hypothesize that: a) TB will increase circulating hepcidin and thereby     impair dietary iron absorption and systemic utilization of iron, resulting in iron     sequestration and anaemia; b) TB treatment and resolution of inflammation over 6 months will     decrease circulating hepcidin, correcting these impairments and improving iron status and     hemoglobin; c) the majority of iron utilized to replenish hemoglobin during recovery from TB     will come from mobilization of sequestered iron stores rather than from iron absorption.      Objectives: Use iron stable isotopes to characterize iron balance over six months of TB     treatment, and specifically to: a) quantify oral and intravenous iron incorporation (oral     absorption and systemic iron utilization) at three time points during TB treatment (acute     disease, after the intensive treatment phase and at completion of the continuation treatment     phase); and b) determine the effect of treatment on iron mobilization from stores to     replenish hemoglobin.      Methods/Subjects: Using a triple stable-isotope technique, iron absorption from labelled test     meals (57Fe) and systemic iron utilization after labelled intravenous doses (54Fe, 58Fe) will     be determined in 18 Tanzanian subjects with newly diagnosed pulmonary TB. The subjects will     be studied at three time points (i) the day after TB diagnosis while infected, (ii) after 8     weeks of intensive phase treatment, and (iii) after another 16 weeks of continuation phase     treatment. Iron status, hemoglobin, hepcidin and inflammation indexes will be measured at     each time point. Isotope enrichment during the two treatment phases will be measured to     estimate the relative rates of iron absorption and mobilization from stores during the     intensive and continuation phases to determine the relative contributions of iron absorption     and iron mobilization from stores during TB treatment and recovery.      Outcome: These studies will provide important new insights into the aetiology of anaemia and     iron metabolism in TB patients. The results will provide essential data for evidence-based     recommendations on the timing, administration route and efficacy of iron therapy in patients     with TB, making possible, a safer and more effective treatment of anaemia in TB while     decreasing morbidity and mortality from the disease.   "
84745|NCT02176759|"     Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify     rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the     food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance     the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP     need to be investigated. The primary objectives of the present study are: 1) to test whether     the presence of citrate in iron fortified rice with FePP results in higher iron     bioavailability, and 2) to test whether the presence of citrate in the rice grain during the     extrusion and cooking process results in higher iron bioavailability compared with     iron-fortified rice where citrate has been added shortly before consumption. As a secondary     objective the investigators will compare the absorption from different FePP combinations with     a reference meal fortified with ferrous sulphate. The investigator hypothesize that the     addition of citrate enhances iron absorption and that the positive effect is greater when the     citrate is added during the extrusion.      The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to     evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2)     regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate     added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at     the time of consumption. Iron absorption will be measured as erythrocyte incorporation of     stable iron isotopes at least 14 days after the administration of the isotopically labelled     test meals. The iron absorption from the different meals within the same participant will be     compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.      The present study will provide important data where iron bioavailability from rice is     accurately and directly measured using stable isotopic labels as absorption tracers. This     direct data can be used to base decisions on the level of fortification, can potentially     reduce costs and optimize iron delivery to the targeted population in iron fortification     programs.   "
84747|NCT02176733|"     The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission     of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive     blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral     bilateralisation taking place in the vast majority of cases in weeks or months. The     neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting     the anti-apoptotic mechanisms) are particularly promising.      The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase     of the disease process and would limit the loss of visual acuity and improve the visual     prognosis of these patients.   "
84748|NCT02176720|"     It was previously shown that [18F]Fluorodopa (FDOPA) PET imaging results in intended     management changes in 41% of brain tumor patients. However, its impact on patient outcome     defined as survival, costs, and/or quality of life has not been demonstrated. Regulatory     agencies require randomized trials to determine the impact of PET on patient management and     outcome. In this study we hypothesize that the addition of FDOPA PET will improve patient     outcome by more accurately identifying presence or absence of tumor recurrence than     conventional imaging.   "
84749|NCT02176707|"     As there are no validated tools for assessing patient reported outcomes or health related     quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised     different methods. This means that comparison of the outcomes of studies is difficult or     inaccurate. By collecting different quality of life tools and patient reported outcome at the     same time, it will be possible to map or model the results of one tool or groups of tools     onto another. 250 patients with IPF will be asked to complete the EuroQoL 5D, Kings Brief     Interstitial Lung Disease questionnaire, St George's Respiratory Questionnaire, MRC dyspnoea     scale, University of California, San Diego shortness of breath questionnaire and the Hospital     Anxiety and Depression Scale, along with spirometry every 3 months, and undergo a 6 minute     walk test every 6 months, over a 12 month period. Prognostic models will be constructed from     all the clinical (questionnaire and function) measures a linear regression model.   "
84750|NCT02176694|"     A randomized controlled trial of a texting intervention to increase adherence to preventative     asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.   "
84751|NCT02176681|"     Diabetes is a major concern for dialysis units, as it is now the most common cause of     end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one     patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2     diabetes) and especially in East part of France.      Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly     from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients     has an important impact in reducing risk of progression nephropathy. Data are scarce on how     diabetes should best be treated in dialysis patients. The evidence for improving glycaemic     control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed,     many factors make improving glycaemic control in patients on dialysis very challenging,     including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties,     dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.      Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are     contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment.     Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues     have become available, but until recently, renal failure has precluded their use. Newer     gliptins, however, are now licensed for use in 'severe renal failure', although they have yet     to be trialed in dialysis patients.      The investigators study, using continuous glucose monitoring as a new tool for monitoring of     therapy should provide information on vildagliptin in add on therapy to insulin in this     population.   "
84752|NCT02176668|"     The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of     YH4808 New Formulation in healthy volunteers.   "
84753|NCT02176655|"     This study proposes to compare the efficacy of sumatriptan and aspirin to placebo as an acute     abortive treatment for delayed alcohol induced headache in adult subjects.   "
84754|NCT02176642|"     This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve     stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in     women undergoing treatment of urgency urinary incontinence (UUI).      The investigators hypothesize that combination therapy with PTNS and anticholinergic     medication will result in a significant incremental improvement in UUI symptoms over that     achieved with PTNS alone. In addition, the investigators hypothesize that the addition of     anticholinergics to PTNS will result in a greater improvement in patients' perception of     treatment response, symptom distress, and quality of life than PTNS alone.      Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day     using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus     placebo in women undergoing treatment for UUI.      Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus     anticholinergic medication versus PTNS plus placebo.      Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of     life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the     Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire     Short Form (OABq-SF).      An interim analysis will be conducted by an independent entity after 50 participants have     completed the study protocol. A Data Safety Monitoring Board is not utilized because the     study utilizes FDA approved treatments for urgency urinary incontinence.   "
84770|NCT02176421|"     A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for     the correction of skin depressions in the infra-orbital area (under the eyes)   "
84810|NCT02175901|"     No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple     therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and     safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple     regiment for Helicobacter pylori eradication.   "
84856|NCT02175303|"     To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and     inflammation, with special focus on allogeneic hematopoietic cell transplantation patients.     The hypothesis to be tested is that the cells are safe to infuse and that they have an     anti-inflammatory and healing effect.   "
84755|NCT02176629|"     Cognitive and memory problems characterize Alzheimer's disease (AD). Along with these     disorders, psychological and behavioral symptoms (also known as neuropsychiatric symptoms) ,     as well as pathophysiological processes are frequently found and involved significantly in     maintaining autonomy, prognosis and treatment of the disease. Apathy or disorder motivation     is the most common disorder behavior and early stages of cognitive impairment. Apathy is     particularly associated with cognitive difficulties such as attention deficit disorder -     concentration.      In terms of prevention as term care , there is now a broad consensus that interventions on     cognition and behavior must not be limited to pharmacological treatment but should also     promote non-drug approaches.      Interest in video games (serious games and serious games) as intervention support     rehabilitation is growing. Similarly, the virtual reality (VR) and the new information     technologies and communications offer significant opportunities in terms of rehabilitation     and therapeutic assistance.      This protocol is part of a European project to propose techniques for improving the treatment     of people at risk of social exclusion ( VERVE project ) aims .      A first experiment conducted in 2013 showed the acceptability of Virtual Reality (VR) in     healthy elderly subjects. In a second step , it is important to validate the feasibility of     using the RV or in frail subjects with mild cognitive impairment or Alzheimer's disease in     mild to moderate in a clinical environment.      This is a biomedical , randomized given to a group of patients with mild cognitive impairment     or Alzheimer's disease & diseases associated with mild to moderate.   "
84756|NCT02176616|"     1. Purpose of the study      1) To compare clinical outcome, procedure time, complication rate of patients who were     changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between     ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary     vein isolation with conventional linear ablation.      2. Scientific evidence of the study        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed          significant reduction of mortality.        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus          non-drug therapy such as catheter ablation is developed.        3. catheter ablation has been performed for 10years world-wide, and showed superior          treatment outcome compared with drug therapy.        4. However, there are no consensus for proper ablation strategy in patients who were          changed to paroxysmal atrial fibrillation from persistent atrial fibrillation .        5. additional ablation make extent of myocardial injury and paradoxically increase          recurrence rate, thus still controversial.        6. Therefore, we will compare conventional pulmonary vein isolation with additional          conventional linear ablation.      3. Methods        1. Treatment of All patients with atrial fibrillation is performed according to the          standard treatment guideline of atrial fibrillation.        2. there is no additional blood sampling, imaging study, or any other invasive procedure          according to the inclusion of the study.      4. study contents      1) to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial     fibrillation from persistent atrial fibrillation        -  compare conventional pulmonary vein isolation with additional liner ablation, both          strategies are conventional ablation strategies being performed world-wide.   "
84757|NCT02176603|"     The purpose of this study is to determine whether adolescent and adult patients with     phenylketonuria who are on long-term phenylalanine-restricted diet suffer from endothelial     dysfunction.   "
84758|NCT02176590|"     This project will test the proximal and distal effects of an integrated dual-generation     intervention, Power PATH, in Head Start preschoolers and their parents in Alabama.   "
84759|NCT02176577|"     The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the     Treatment of Atopic Dermatitis in Adolescent Subjects.   "
84760|NCT02176564|"     A pharmaco-epidemiological, observational study that aimed at assessing in a prospective     manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD)     patients treated with inhaled bronchodilators   "
84761|NCT02176551|"     The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric     subjects with Mild to Moderate Atopic Dermatitis.   "
84762|NCT02176538|"     The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric     subjects with Mild to Moderate Atopic Dermatitis.   "
84763|NCT02176525|"     The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics     of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both     treatment-naïve patients and patients previously treated with peginterferon and ribavirin     were included. In addition, the effect of study medication was examined in a group of     patients with liver cirrhosis.   "
84764|NCT02176512|"     Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose     combination in comparison to the single unit formulations   "
90884|NCT02096497|"     Retrospective analysis to the course and branching pattern as well as surgically relevant     inner diameters and lengths of the superficial temporal artery (STA) by digital subtraction     angiographies (DSA).   "
84765|NCT02176499|"     Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate     hypertensive patients on a controlled sodium diet as well as to explore the effects of     telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine     potassium, creatinin, chloride, bicarbonate and uric acid excretion. Additionally it was     assessed whether the natriuretic effect disappears after treatment when telmisartan is     stopped. The effects of telmisartan on seated clinic blood pressure and the relationship     between urine sodium loss and decrease in ambulatory blood pressure after the first dose were     assessed descriptively. Assessment of safety was also considered.   "
84766|NCT02176486|"     The purpose of this study is to characterize the safety and tolerability of ixazomib when     administered as multiple oral doses at escalating dose levels in participants with lupus     nephritis.   "
84767|NCT02176473|"     In an open-label feasibility study, fifteen will be recruited to participate in the study     from among those who have already chosen of their own accord to undergo ECT (standard of     care) at Yale Psychiatric Hospital for treatment of a depressive episode. These patients will     receive computer-assisted cognitive behavior therapy (CCBT).   "
84768|NCT02176460|"     Uric acid may be involved in the activation of the innate immune response in osteoarthritis     (OA) pathology and progression. This suggests that traditional gout therapy may be beneficial     for OA. Our goal therefore is to assess colchicine, an existing commercially available agent     for gout, for a new therapeutic indication-knee OA. The investigators propose a randomized     clinical trial (RCT) of 16 weeks' therapy with standard daily dose oral colchicine or placebo     for knee OA. The investigators hypothesize that colchicine will block inflammasome mediated     inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid, serum     and urine inflammatory and biochemical joint degradation biomarkers. This trial will     potentially provide data to support a new treatment option for knee OA.   "
84769|NCT02176434|"     This pilot study of combined kidney and hematopoietic stem cell transplantation attempts to     establish a protocol to induce immunological tolerance as a new strategy to prevent renal     graft rejection. If successful, this strategy would restore renal function, while avoiding     the risks associated with long-term standard anti-rejection therapy, and would represent the     first option to cure end-stage renal disease.   "
84771|NCT02176408|"     Major depressive disorder (MDD) is the leading cause of disability in the developed world and     is associated with lost productivity, increased health care utilization, and mortality.     Several empirically supported treatments, such as antidepressant medication and cognitive     behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many     as 34% of individuals do not respond to these treatments. Exercise and stretching     interventions represent alternative strategies associated with strong effect sizes in past     studies. Additionally, exercise has been shown to enhance cognitive functioning, especially     attention and memory. This study aims to investigate the effect of a combined aerobic     exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment     involves completing both pleasant and mastery-based activities with the goal of enhancing     mood. The current study will recruit 32 MDD patients for an active treatment phase of nine     60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise     (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding     aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an     active control condition.   "
84772|NCT02176395|"     The purpose of this study is to explore the pharmacological mechanism of Danhong injection in     the treatment of acute ischemic stroke.   "
84773|NCT02176382|"     The aim of the study is to assess the effect of an antiresorptive medication in combination     with standard dose or alternate dose teriparatide.   "
84774|NCT02176369|"     Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death     worldwide with 1.4 millions of deaths every years. Current standard therapies include     platinum-containing drugs but at one year from diagnosis the survival rate is still low     (30-40%) .      The purpose of this study is to evaluate the role of a platinum-free drug, named Vinorelbine,     administered by the so called metronomic schedule in order to prolong the progression free     survival of patients.   "
84775|NCT02176356|"     A study to evaluate patient satisfaction, aesthetic and psychological impact of combined     treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS     XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).   "
84776|NCT02176343|"     The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ     ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months     and no more than 14 months after IOL implantation.   "
84777|NCT02176330|"     The purpose of this study is to assess the impact of using a virtual clinic which combines a     web-based interactive questionnaire (ePAQ-PF) used in advance of clinic appointments in     combination with a telephone consultation has on patient experience and cost compared to     standard care.   "
84778|NCT02176317|"     This study is a prospective phase 1 single-center trial designed to determine the safety of a     single intravenous infusion of autologous umbilical cord blood in children with Autism     Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine     which measure(s) can be used as primary and secondary endpoints for a future randomized phase     2 clinical trial. All subjects will receive infusion of cord blood cells at baseline with     follow up assessments at 6 and 12 months.   "
84796|NCT02176083|"     Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments     that impair ovarian function and result in significant reproductive health late effects.     These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal     dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this     pilot study is to test the feasibility of a 4-week text message based intervention on hot     flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the     intervention (text messages on hot flash and vaginal dryness management) and control arms.     All participants will be prompted to provide daily hot flash frequency and severity via text     messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting     via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash     severity and vagina dryness between the intervention and control arms.   "
84779|NCT02176304|"     Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the     aging population, a 40% patient increase is expected to present at clinics with complaints of     primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical     criteria for knee arthritis and usage of resources to avoid major surgery. It has long been     accepted as a treatment option for patients who have failed to respond to NSAIDs and other     non-surgical therapies to receive intra-articular injections of steroid and anesthesia     mixtures to hold off disease progression.      Various studies have compared different sites of injection and the accuracy rate of the     injection being within the joint. Recent studies report a 66% accuracy on palpation-guided     injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the     superolateral portal of the knee, and new studies show an improvement of up to 98% with use     of ultrasound guiding software. However, in a health care system with limited resources,     providing patients with US-guided injections represented an increased cost of $178.35 per     patient as per 2010 Medicare reports.      Therefore, assuming these accuracy rates, we will compare the anterolateral and superolateral     portals for knee injection and their clinical effect to monitor if in fact there is a     difference in patient reported outcomes. As a secondary analysis, if no difference is found,     a strong case for palpation-guided injections versus ultrasound-guided injections can be     made.      In this study we will prospectively enroll 60 patients to be divided into two 30 patient     groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated     with an intraarticular knee injection through an anterolateral portal or a suprapatellar     portal as per group in which they are placed. Scores will be given for pain of the injection     and of the baseline illness and compared on a subsequent visit to assess self-reported     functional outcomes.   "
84780|NCT02176291|"     The purposes of this project are to examine the feasibility, safety, tolerability and     clinical effect of low-dose buprenorphine as a novel treatment for late-life     treatment-resistant depression and to develop preliminary data about mechanism of action.   "
84781|NCT02176278|"     In this quality improvement program (DKD-TMT), patients will be recruited from multiple sites     across Asia, with each site recruiting at least 300 type 2 diabetic patients with Diabetic     Kidney Disease (DKD). After explanation by trained doctors and nurses, and with written     informed consent, patients will be randomized to the UC (n=100, usual care) group, the EC     (n=100, empowered care) group, or the TEC (n=100, team-based, empowered care) group. Patients     in all 3 groups will undergo a comprehensive assessment (CA) guided by the templates in the     Joint Asia Diabetes Evaluation (JADE) portal at baseline and at month 12. They will also     self-administer a set of questionnaires for assessing quality of life and psychological     distress during the CA at both time points.      During the 12 months between the 2 CAs:        -  Patients in the UC group will receive UC in accordance to the practice of the health          institution.        -  Patients in the EC group will receive a JADE summary report with personalized risk          prediction, treatment targets and decision support with explanation from the doctor and          nurse. In addition to receiving UC in accordance to the practice of the health          institution, the nurse will telephone the patient 3-monthly to remind them to adhere to          treatment, provide support and empower them to discuss with their doctors about their          treatment needs and any concerns.        -  Patients in the TEC group will be followed by a doctor-nurse team at least 3 monthly to          achieve multiple targets, but tailored to patients' risk profile. The patients will          receive telephone reminders and also be given a JADE follow up report 3-monthly.      The primary composite endpoint is attainment of treatment goals and/or control of risk     factors. The secondary composite endpoint is all-diabetes related clinical endpoints. The     tertiary changes are behavioral changes, psychological well-being and quality of life.   "
84803|NCT02175992|"     Pancreatic cancer has a high mortality rate. Patients with an intended curative resection     show a median survival of 17-23 months. Therefore, quality of life is very important in this     patient group. In this study, the effect of pancreatic surgery on quality of life is     measured.   "
84804|NCT02175979|"     The main objective is to investigate the effects of perioperative nutrition on postoperative     ileus and anastomotic leakage in patients undergoing colorectal surgery.      Perioperative enteral nutrition is compared to the standard of care (fasting     perioperatively).   "
84805|NCT02175966|"     The purpose of the study is to determine whether the combination of Daclatasvir (DCV),     Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C     virus.   "
84782|NCT02176265|"     Objective of this First in Man study is to assess feasibility and safety of Qvanteq's     bioactive coronary stent for treatment of stable coronary artery disease patients with de     novo coronary artery stenosis in native vessels.      The proprietary surface of Qvanteq's bioactive coronary stent improves the in-growth behavior     of the stent in the treated vessel. In-vivo animal studies revealed fast in-growth (similar     to BMS), which however is not resulting in excessive tissue overgrowth as observed in BMS but     rather has an efficacy profile similar to drug-eluting stent (DES), meaning suppression of     tissue overgrowth. This should reduce the risk of restenosis and thrombus formation despite     the presence of a short term dual anti platelet therapy (DAPT). Furthermore, prolonged DAPT     time as applied with current DES increases the bleeding risk of patients.      The study is a prospective, multicenter, open-label, single arm study; conducted in up to 6     cardiology centers in CH and NL. In total, approx. 35 patients will be enrolled. All patients     will be treated with the Qvanteq's bioactive coronary stent. Clinical follow-up will occur at     1, 6 & 12 months post-stent implantation. All patients will undergo angiography assessment     (QCA) and Optical Coherence Tomography investigation (OCT) at baseline and at 6 months     follow-up. Baseline OCT should be performed after the successfully completed angiographic     procedure (documentary OCT). 1 and 12 months clinical follow-ups are conducted via telephone.      Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months; assessed by off-line     QCA. Primary OCT endpoint is mean neointimal thickness at 6 months; assessed by off-line OCT     analysis.   "
84783|NCT02176252|"     The study is designed to evaluate the safety, tolerability, pharmacodynamics and     pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days     in order to allow for including Japanese subjects in future global studies. A cohort of     Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by     digital ECGs (dECG) recordings, also in Caucasian subjects.   "
84784|NCT02176239|"     The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment     naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients     using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and     disability assessments using CareExchange in the home setting.   "
84785|NCT02176226|"     This study will evaluate a Smartphone intervention for depression and anxiety that uses     machine learning to tailor treatment for patients. The intervention, referred to as     IntelliCare, delivers patient-specific treatment material and motivational messaging via a     mobile phone, to help individuals with depression and/or anxiety. Information and data     received from the patient will inform the tailored treatment approach through machine     learning. The purpose of this study is to obtain preliminary information on the feasibility     and effectiveness of IntelliCare in improving symptoms of depression and anxiety.   "
84797|NCT02176070|"     The purpose of this study is to learn about reproductive health, including fertility and     pregnancies, in people with vasculitis.   "
84993|NCT02173522|"     The purpose of this study is to determine whether pre-operative prostate artery embolization     (PAE) reduces intra-operative blood loss and improves surgical outcomes among prostate cancer     patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP).   "
84786|NCT02176213|"     This study is being done to learn more about the drug, pomalidomide and to gather data on its     safety and side effects when used in combination with commercially available cyclophosphamide     and dexamethasone. This combination is considered experimental and has not been approved by     the FDA.      Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent     version of thalidomide and lenalidomide drugs that have been approved by the United States     Food and Drug Administration [FDA] for the treatment of MM. In February 2013, pomalidomide     was also approved by the FDA for patients with MM who have had more than 2 types of therapy.      Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also     taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially     available and are often used in combination with other drugs to treat Multiple Myeloma.     Preliminary data from both the laboratory and patient studies suggest that this combination     of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen     being used in this study, which consists of daily cyclophosphamide, also permits support of     low blood counts with either injections or transfusions as needed.   "
84787|NCT02176200|"     Study to compare the lung and oropharyngeal deposition of Berodual® (fenoterol hydrobromide     50μg + ipratropium bromide 20μg /1x puff) delivered via the Respimat® inhaler and the same     dose of Berodual® delivered via an hydrofluoroalkane (HFA) - metered dose inhaler (2 x puffs     ) in COPD patients at different inspiratory flow rates.   "
84788|NCT02176187|"     Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage     of the dose received from the Respimat® inhaler and metered dose inhaler   "
84789|NCT02176174|"     Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary by     ethnic group. However, less is known about differences between ethnic groups and a wider     range of cardiovascular diseases. This study will examine differences between ethnic groups     (White, Black, South Asian and Mixed/Other) and first lifetime presentation of twelve     different cardiovascular diseases. This information may help to predict the onset of     cardiovascular diseases and inform disease prevention strategies.      The hypothesis is that different ethnic groups have differing associations with the range of     cardiovascular diseases studied.   "
84790|NCT02176161|"     This is a Phase II clinical study to determine if Metformin can increase Prostate Specific     Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary     treatment with radiation, or surgical patients that are at high risk for recurrence based on     surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will     receive Metformin and will be monitored for PSA response and disease progression.   "
84791|NCT02176148|"     Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many     presentations. Its effect on physical appearance greatly affects patients' quality of life.     In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical     therapies are the mainstay of cutaneous lupus treatment; however patients often find these     treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease     patients are often placed on concurrent systemic therapies. The primary hypothesis of our     study is that poor adherence contributes to poor treatment outcomes in patients with     cutaneous lupus.   "
84792|NCT02176135|"     The main purpose of the study is to evaluate the safety of oral auranofin, a gold compound,     in patients with HIV infection whose viral load has been suppressed by antiretroviral therapy     for no less than 3 years and have a CD4+ cell count over 500 cells/uL   "
84793|NCT02176122|"     No randomized controlled trials (RCTs) have yet been performed comparing different treatment     options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen     an exponentially increasing rate of carbapenem resistance worldwide, including Australia and     New Zealand. The investigators urgently need data from well-designed RCTs to guide clinicians     in the treatment of antibiotic resistant Gram-negative infections. The investigators face a     situation where a commonly used antibiotic for these infections (meropenem) may be driving     carbapenem resistance. For this reason, the investigators are seeking to compare a     carbapenem-sparing regimen with a carbapenem for the treatment of these infections. Formal     evaluation of safety and efficacy of generic antibiotics in the treatment of infection is of     immense clinical and public health importance, and no formal trial has yet been conducted to     address these issues. The international collaboration between teams of clinician researchers,     some of whom are leaders in their field, makes it highly likely that the outcomes of this     trial will have a significant impact on clinical practice.      The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen)     is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of     bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or     Klebsiella species.   "
84794|NCT02176109|"     In this study, the investigators study the prognostic role of oxidative stress metabolism and     iron in Acute myeloid leukemia.   "
84795|NCT02176096|"     The objective of this demonstration project is to compare a novel long-acting starch,     Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy     tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade     has been reported to increase the duration of euglycaemia. Its slow release and longer     periods of normal blood sugar achieved would preclude the need for the overnight dextrose     infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this     purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus     potentially improving compliance to therapy. The investigators intend to evaluate Glycosade     in our patients and determine its efficacy on glucose control, on the length of normoglycemia     achieved and to determine if there are reduced side effects in our patients with GSD-I. This     will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the     protocol.   "
84815|NCT02175836|"     Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic     Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern     Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden     Cardiac Death Prediction.   "
85015|NCT02173236|"     The impact of platform switching with flapless surgery on early-loaded single-tooth implants     on esthetic outcomes.   "
84798|NCT02176057|"     The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can     be eliminated in communities in Nepal following mass antibiotic distributions with     azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis     infection. The overall objective is to determine if the current World Health Organization     (WHO) treatment strategy results in elimination of trachoma and infection.        1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham          districts of Nepal which receive mass antibiotic treatments will achieve elimination of          trachoma as a public health problem (clinical disease <5% in children 1-9 years old)          more frequently than communities which have not received antibiotic treatments.        2. The investigators hypothesize that infection with C. trachomatis will be undetectable in          all members within a community following mass treatment as determined by the most highly          sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and          Achham districts of Nepal which receive mass antibiotic treatments will achieve          elimination of trachoma as a public health problem (clinical disease <5% in children 1-9          years old) more frequently than communities which have not received antibiotic          treatments.      2. The investigators hypothesize that infection with C. trachomatis will be undetectable in     all members within a community following mass treatment as determined by the most highly     sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based     AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and     DNA-based AMPLICOR PCR).   "
84799|NCT02176044|"     Spatial working memory (ability to remember where objects are in space) is impaired in     patients with schizophrenia. It is thought that this impairment occurs due to problems with     the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA)     glutamate receptor, particularly in the hippocampal brain region. NMDA receptor activation     leads to increases in the release of the second messenger Nitric Oxide. Impaired NMDA     receptor function would therefore be predicted to lead to reductions in Nitric Oxide     production. Recent work suggests that a drug, sodium nitroprusside, which releases nitric     oxide, enhances some aspects of cognition in schizophrenia (specifically related to negative     symptoms). In this study, the investigators will test the hypothesis that sodium     nitroprusside improves spatial working memory in patients with schizophrenia. 15 patients     will receive sodium nitroprusside, and 15 will receive a nonactive compound (placebo). Their     performance on a spatial working memory task will be tested before and after administration     of sodium nitroprusside or placebo.   "
84800|NCT02176031|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug Natalizumab in treating Acute Graft versus Host Disease in the     Gastrointestinal Tract.   "
84801|NCT02176018|"     The purpose of this study is to evaluate the efficacy and effectiveness of daily     dextromethorphan/quinidine (Nuedexta) in reducing the frequency and progression of episodic     migraine.   "
84802|NCT02176005|"     The purpose of this study is to determine whether DAV132 is safe and effective for capturing     fecal residues of moxifloxacin in healthy volunteers.   "
84811|NCT02175888|"     Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem     worldwide, especially in women of reproductive age and young children. Iron supplementation     is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron     bioavailability from different supplementation regimens and how to optimize bioavailability     in a cost-effective and patient-friendly way. The present study will test whether the     fractional and total iron absorption from iron supplements (60 mg) administered daily for 14     days differs from that of iron supplements (60 mg) administered every second day for 28 days.     The prevailing serum hepcidin concentration (SHep) is the major determinant of iron     absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole     supplementation period. We hypothesize that the fractional and total iron absorption from the     daily administration of 60 mg is lower than that from the administration on every second day     due to increased SHep levels when supplements are administered daily.      The study will provide important insights about the optimization of iron bioavailability from     different supplementation regimens including the performance of SHep, a key regulator of     human iron metabolism.   "
84812|NCT02175875|"     The study will investigate the effect of the oral antiplatelet agent ticagrelor (Brilique)     when it is administrated through a nasogastric tube in comatose patients. The platelet     function can be determined by various platelet function tests (PFT), Multiplate and VerifyNow     . As control, the reference intervals from the literature are used. Futhermore, plasma     concentrations of the active metabolite will be determined at aeveral timepoints after first     intake of a bolus dose.   "
84813|NCT02175862|"     In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS)     was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.      In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus     Hesselfeldt, conducted an observational study to investigate the possible effects on time to     definitive care, secondary transfers and 30-day mortality in a before and after design.      Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min     to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day     mortality significantly reduced from 29 % to 14 % in the year after implementation.      The present study is an observational cohort study with long-term follow-up of the same     trauma population as mentioned above. Patients were followed until may 1st, 2014.      Primary outcome is early retirement and secondary outcomes are quality of life and mortality.      The investigators hypothesize that a greater proportion of trauma patients in the after     period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients     treated in the before period.   "
84814|NCT02175849|"     Tuberculosis burden in Vietnam increasing with contribution from low detection rates and     increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant     Tuberculosis) among both notified TB cases and their contacts in the community. Traditional     contact tracing often focuses on household contacts while strains of TB circulate in homes,     schools, workplaces, and beyond. Social network Analysis (SNA) is a comprehensive approach     which includes a set of persons and the connections among them used for analysis of structure     of disease transmission.      In this study, SNA will be used to collect network data from 60 newly detected Rifampicin     resistant TB patients including an expected 50 MDR-TB patients living in Hanoi, and to     identify and test potential MDR-TB cases.   "
84816|NCT02175823|"     To improve quality of life of elderly cancer survivors        1. Using physical activity and environmental sensing technology        2. Monitoring physiological indicators of cancer recurrence             -  Analyzing the patient's circadian rhythm, frailty and his/her vital sign.             -  Vital sign includes blood pressure, weight and hrv.        3. Collecting the patient information in real time             -  Giving alarm information to the patient, if any special cases our system found.             -  Giving circadian rhythm report to the patient.             -  Giving healthy report to the patient, collected from his/her vital sign.   "
84817|NCT02175810|"     Obesity is a growing problem worldwide and its prevention has become one of the leading     priorities for the World Health Organisation. Obesity results from chronic imbalance between     energy intake and energy expenditure. Although early prevention of obesity is preferable,     surgical treatment is often required for severely obese people.      Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight     loss following bariatric surgery results in significant improvements in coexisting     comorbidities, such as diabetes and hypertension but there is controversy whether bariatric     surgery also improves aerobic capacity.      The purpose of this study is to investigate the effects of bariatric surgery on     cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric     surgery will improve aerobic capacity and result in beneficial lifestyle changes from     sedentary to more active.   "
84818|NCT02175797|"     The purpose of this study is to report the stability of atrial and ventricular leads by     absence of effect of the MRI exam on the pacing and sensing threshold and to report the     safety based on the serious adverse events.   "
84819|NCT02175784|"     The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin     based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes     mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term     (52 weeks) safety and the persistence of the efficacy will also be evaluated.   "
84820|NCT02175771|"     The primary objective of the study is to evaluate the long-term safety of fluticasone     propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol     inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder     inhaler (MDPI) device over 26 weeks in patients with persistent asthma.   "
84851|NCT02175368|"     Investigation on the clinical performance of a new dental adhesive when used in direct     filling therapy after phosphoric acid etching.      Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good     filling quality.   "
93245|NCT02065557|"     The purpose of the study is to demonstrate the efficacy and safety, and to assess the     pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with     moderate to severe ulcerative colitis (UC).   "
84821|NCT02175758|"     This study will have two parts as follows:      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and     confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric     participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days     of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF     dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the     Treatment Phase with no interruption of study drug administration. The Treatment Phase will     evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in     pediatric participants with genotype 2 or 3 HCV infection, respectively.   "
84822|NCT02175745|"     To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly     diagnosed or recurrent gliomas.   "
84823|NCT02175732|"     Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that     arise through living with and managing diabetes. High DD is characterized by feeling     frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a     negative impact on disease management and glycemic control; poor glycemic control can also     have a negative effect on DD.      Few interventions have been assessed that directly target DD or mood in adults with Type 1     diabetes. In this study the investigators will compare two active, evidence-based behavioral     interventions to reduce high DD and improve glycemic control and disease management:        1. A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in          diabetes education and behavioral management.        2. A DD-reduction protocol ('OnTrack') that helps identify and address the personal          stresses and strains of having diabetes.      Participants in both arms will attend a single, day-long workshop, four hour-long web group     meetings and four personal phone calls with the group facilitator during the intervention     period. Assessments will be carried out at baseline and at three and nine months.      Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at     follow-up.      Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the     difference between the two study arms and primary outcome.      Hypothesis 3: The differences between the two study arms and changes in the primary outcomes     will be qualified by patient characteristics such as age, length of diagnosis, higher     baseline distress or HbA1c.   "
84824|NCT02175719|"     Investigation of the clinical condition in patients with cervical dystonia by Toronto Western     Spasmodic Torticollis Scale (TWSTRS)   "
84835|NCT02175576|"     Randomized Controlled Study to determine if preservation of ligaments provides increased     functional ability post-operatively in comparison to traditional TKA which sacrifices soft     tissue.   "
84836|NCT02175563|"     According to the European Resuscitation Council (ERC) Guidelines for patient to a depth of     approximately 5-6 cm on a firm and flat surface when possible. However, Cardiopulmonary     resuscitation (CPR) performers may need to continue the chest Resuscitation 2010, CPR     performers should compress the sternum of a compression in an oblique direction, such as in     elevators. For a pregnant patient in cardiac arrest, the 2010 ERC Guidelines recommend that     the performer place the patient in a left-lateral tilt of 15 - 30° using a firm wedge to     support the pelvis and thorax because the pregnant uterus can compress the inferior vena     cava. We hypothesized Smartphone based chest compression feedback app would improves quality     of CPR in an angulated surface.   "
90946|NCT02095691|"     This is a prospective, multi-center, non-randomized, feasibility study to assess the safety     and effectiveness of renal artery sympathetic denervation using the investigational devices     in subjects with resistant hypertension.   "
84825|NCT02175706|"     Rationale:      The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has     led to a significant reduction in morbidity but there are further demands on DES performance.     Such demands are an optimized performance in very challenging coronary lesions; third     generation DES were developed in an effort to further improve DES performance in such     challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus     Element stents) are currently available; there are no data that indicate an advantage of one     of these DES over the other.      Objective:      To investigate whether the clinical outcome is similar after implantation of the Promus     Element versus the Resolute Integrity stent (non-inferiority hypothesis).      Study design:      Multicenter, prospective, randomized single-blinded study.      Study population:      Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary     stenoses with an indication for DES use, according to current guidelines and/or the operators     clinical judgement. All clinical syndromes will be included.      Intervention:      In patients who are eligible for DES implantation, the type of DES implanted will be     randomized (Resolute Integrity stent versus Promus Element stent). At the start of the study,     both DES will also be used in routine clinical practice.      Main study endpoints:      The primary endpoint is the incidence of target vessel failure at one year follow-up. Target     vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI,     or clinically driven target vessel revascularization. Further secondary clinical and     angiographic endpoints will be investigated, defined in accordance with suggestions of the     Academic Research Consortium (ARC). Of note, the angiographic assessment is based on     clinically indicated projections only and results in no additional x-ray exposure. There is     no routine angiographic follow-up. If angiographic data are available in patients who undergo     symptom-driven re-catheterization, we will analyze these data to get insight into the     mechanisms of potential DES restenosis.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Patients will receive the routine clinical treatment. As a consequence, the     risks of this trial do not exceed the risks of any routine PCI procedure.   "
84826|NCT02175693|"     Investigation of the clinical condition and safety in patients with cervical dystonia   "
84827|NCT02175680|"     This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of     PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on     combination antiretroviral therapy.      Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140     monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one     week overlap of existing retroviral regimen and PRO 140 at the beginning of the study     treatment, and one week overlap at the end of the treatment in subjects who do not experience     virologic failure.   "
84828|NCT02175667|"     Determine the influence of a treatment with Global Postural Reeducation techniques and the     personality traits in the stabilometric parameters   "
84829|NCT02175654|"     The purpose of this study is to assess the efficacy of single-agent regorafenib in the     second-line treatment in metastatic colorectal cancer with any RAS or BRAF mutation     previously treated with FOLFOXIRI plus bevacizumab in terms of progression-free survival at 6     months.   "
84830|NCT02175641|"     This goal of this randomized controlled effectiveness trial is to compare the effectiveness     of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in     supportive housing agencies in New York City and Philadelphia serving diverse clients with     serious mental illness who are overweight or obese. The intervention follows the Group     Lifestyle Balance curriculum derived from the Diabetes Prevention Program and that has been     shown to help people achieve clinically significant weight loss (equal to or greater than 5%     weight loss of initial weight). The intervention will be delivered by trained     peer-specialists employed at the supportive housing agencies and supervised by the study     team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by     improving people's diet and increasing their physical activity and consists of weekly core     group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance     monthly sessions (6 mo.).      We plan to enroll 300 clients with serious mental illness who are overweight/obese (BMI equal     to or greater than 25) from our two supportive housing agencies. Clients will be randomized     to either the Peer-led healthy lifestyle intervention or usual care conditions. The primary     outcome for this study is achieving clinically significant weight loss (equal to or greater     than 5% weight loss from baseline weight) at 12 and 18 months post randomization. The     secondary outcomes for this study include overall reductions in weight, waist circumference,     blood pressure, and improvements in physical activity, self-efficacy, recovery and     health-related quality of life. Repeated assessments will be at baseline, 6, 12 and 18 month     post randomization.      Primary Hypothesis: Peer GLB participants will have a higher proportion of persons achieving     clinically significant weight loss (equal to or greater than 5% weight loss) at 12 and 18     months than UC participants.      Secondary Hypothesis: At 6, 12, and 18 months post-randomization, there will be significant     reductions in average weight, waist circumference, blood pressure, and significant     improvements in physical activity, self-efficacy, recovery, and health-related quality of     life in Peer GLB compared to UC.   "
84871|NCT02175108|"     This study aims to fill a gap in the literature, identify relevant clinical measures, and     provide insight into the independent modifiable risk factors of obesity in the CP population     with the long-term goal of improving screening, management and prevention of obesity in this     at-risk and underserved population.   "
84831|NCT02175628|"     Purpose: This study will evaluate a new ultrasound imaging technology called acoustic     angiography. Acoustic angiography uses an ultrasound contrast agent, already FDA approved for     use in cardiology, to enhance imaging of blood vessels. Since acoustic angiography uses     ultrasound, and not x-rays, the patient is not exposed to ionizing radiation, unlike     traditional angiography and mammography. Specific goals will be to evaluate the quality of     the images provided by acoustic angiography in the human breast, and furthermore to evaluate     whether or not acoustic angiography provides additional diagnostic information over     traditional ultrasound which could provide an improvement in assessing breast lesions.     Specifically, this additional diagnostic information will hopefully enable us to reduce false     positive tests and discriminate lethal cancers from non-lethal disease.      Participants: The investigators are recruiting 60 patients from the UNC Breast Clinic who are     undergoing core needle biopsy or surgical biopsy (BIRADS 4 and 5 breast lesions).      Procedures (methods): Acoustic Angiography imaging will be performed in conjunction with     standard diagnostic imaging, including b-mode ultrasound . Then, a reader study will be     conducted to compare these modalities. Finally, the images will be analyzed with image     processing techniques to determine quantitative metrics exhibited by the blood vessel     morphology in the images. These metrics will be utilized to develop a malignancy score     equation to predict malignancy of a lesion.   "
84832|NCT02175615|"     The specific objectives of this study are:      Primary:      1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and     severe aGVHD (grade III and IV)      Secondary:        1. To determine the relationship between individual concentration-time points achieved          prior to engraftment and severe aGVHD (grade III and IV)        2. To validate the previously developed LSS to determine cyclosporine AUC after IV          administration at steady state and        3. To describe the relationship between cyclosporine AUC and individual concentration-time          points achieved prior to engraftment and other HSCT outcomes (clinically significant          aGVHD (grade II to IV), hypertension, engraftment failure, relapse   "
84833|NCT02175602|"     The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325     on the pharmacokinetics of selective serotonin reuptake inhibitors.   "
84834|NCT02175589|"     The purpose of this study is to evaluate the effect of discontinuation of colchicine     treatment in a specific group of asymptomatic FMF patients with a single mutation in MEFV     gene, both from a clinical and laboratory aspects.   "
84837|NCT02175550|"     A new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The     implant is a two piece design to allow both one- and two- stage surgical procedures. The     entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to     promote and maintain primary stability, which later on leads to secondary stability.      NR CC implants are used as the foundation for anchoring tooth replacements in either jaw.     Restorations range from replacing one single tooth to an entire arch of bridgework. The     implants are also intended as retentive elements for overdenture applications.      The present study is designed to evaluate, after the insertion of the NR CC, the marginal     bone levels and bone remodelling at the implant sites over various time points up to 5 years.     Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are     as well evaluated together with implant success and survival rate.      Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this     clinical investigation will demonstrate clinical safety and reliability of the NR CC using     different treatment options.   "
84838|NCT02175537|"     The purpose of the study is to pilot-phase test the effectiveness of the microclinic social     induction model and its effects on behavioral and metabolic outcomes in different levels of     social and familial relationships in Qatar. The investigators novel microclinic model is     based on the principle that both healthy and unhealthy behaviors spread through preexisting     social networks. A microclinic is a small group of approximately 2-8 friends or family     members who are taught to modify their own behaviors as well as the behaviors of those around     them, with a particular focus on the four M's: Meals, Movement, Monitoring, and Medication.     More than social support groups or peer-to-peer interventions, the microclinic model is     unique in its focus on the long-term propagation of healthy behaviors throughout a     participant's entire social network. Qatar is uniquely positioned (with its central     geographic location in the Gulf region and its leadership in science and education) to     spearhead a regional intervention focused on managing and preventing diabetes in the Gulf     region.   "
84852|NCT02175355|"     Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more     effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in     patients with isolated systolic hypertension (ISH), and to assess the dose response     relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80     mg.      Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of     Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations,     heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity     of adverse events.   "
84853|NCT02175342|"     This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal     dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks in     patients with COPD.   "
84854|NCT02175329|"     60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered     with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal     is to compare clinical survival , biological or technical behaviour of the restorations.   "
84839|NCT02175524|"     The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS),     the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal     patients. The current study was designed as a case-control study. Patients proved to be oral     and esophageal cancer and had the habit of areca nut chewing are defined as case group.     Patients proved to be oral and esophageal cancer and did not have the habit of areca nut     chewing are defined as control group. The participants' age, blood pressures, and smoking     habits will be recorded. Body weight, height, waist, and hip circumferences will be measured.     Fasting venous blood samples will be obtained to determine hematological parameters [i.e.,     serum creatinine, total cholesterol, triacylglycerol, low density lipoprotein-cholesterol,     high density lipoprotein-cholesterol, malondialdehyde, superoxide dismutase, glutathione     peroxidase, catalase, and inflammatory markers (C-reactive protein, tumor necrosis     factor-alpha, and interleukin-6)]. Logistic regression analyses are going to perform to     examine the relationship between areca nut chewing and MS in this population. If we can make     sure the relationship between areca nut chewing and MS, the clinicians and nutritionists can     teach people to quit areca nut chewing in order to avoid the possibility of developing     metabolic syndrome and cardiovascular disease.   "
84840|NCT02175511|"     Importance: Less than fifty percent of patients with hypertensive disease manage to maintain     their blood pressure (BP) within normal levels. Practical (Pragmatic) and sustainable models     are needed in order to improve BP management in patients with hypertension.      Objective: To evaluate whether cloud BP system integrated with computerized physician order     entry (CPOE) is useful for improving BP management as compared with traditional care.   "
84841|NCT02175498|"     The purpose of this study is to assess the effectiveness of Homoeopathic treatment in female     infertility.   "
84842|NCT02175485|"     Primary Objective:      To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score     (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen     exposure.      Secondary Objective:      To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom     Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about     efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar     pollen exposure.   "
84843|NCT02175472|"     Light treatment was originally employed in Parkinson's disease (PD) to determine if it might     be effective in treating co-existing symptoms of depression and insomnia. However, a     preliminary double-blind study as well as other studies reported significant improvement in     both motor and co-existing Parkinsonian symptoms. As of yet, no long term double blind study     has validated these findings. This study will use a double-blind design to evaluate the     safety and efficacy of a non-invasive light therapy device to be used with ongoing     pharmacotherapy for PD, over a six month treatment period.   "
84865|NCT02175186|"     The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal     Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary     Intervention.   "
85057|NCT02172690|"     RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric     cancer, yet the efficiency have not been fully investigated in Chinese people.      PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as     locally advanced gastric cancer.   "
84844|NCT02175459|"     Regeneration of mature cells that produce functional insulin represents a major focus of     current diabetes research aimed at restoring beta cell mass in patients with most forms of     diabetes. The capacity to adapt in response to diverse physiological conditions during life     and the consequent ability to cope for increased metabolic demands is a distinctive feature     of the endocrine pancreas in the regulation of glucose homeostasis. Both beta and alpha cells     are dynamically regulated to continually maintain a balance between proliferation,     neogenesis, and apoptosis. In this proposal, the investigators will focus on exploring key     mechanism(s) that potentially regulate islet cell plasticity in altered glucose metabolic     states.      Investigators will explore in a unique cohort of individuals who undergo duodenal     pancretectomy. Prior to their surgery will be performed in vivo studies (Hyperglycemic clamp,     Euglycemic Hyperinsulinemic clamp and Mixed Meal Tests) to accurately assess glucose     homeostasis parameters to classify each individual into metabolic phenotypes. Then exploit     the opportunity to collect pancreas samples from these patients who will be evaluated again     after surgery, the investigators will determine the ability of the remnant pancreas to     compensate for the acute reduction in islet mass and perform correlations between ex vivo and     in vivo parameters.      Specifically, the patients will be subjected to incretin secretion (mixed meal), metabolic     status (OGTT), insulin secretion characteristics (first and second phase responses), β-cell     insulin content evaluation (arginine bolus). Subsequently, pancreas samples will be evaluated     for morphometry, and proteomics and gene expression analyses of islet cell samples obtain by     laser capture will allow a detailed investigation of mechanisms that contribute to islet     plasticity. The overall goal of this project is to investigate key mechanisms driving the     ability of islet mass to adapt to diverse metabolic states. We aim to explore modifications     in gene expression and proteomics and correlate them with specific metabolic phenotypes, in     order to determine key regulators of islet morphology.   "
84845|NCT02175446|"     In the second-line treatment setting for MBC, many agents, including antitubulin drugs     (Taxanes, Vinorelbine) and antimetabolites (Capecitabine, Gemcitabine), have demonstrated     activity, but no agent is clearly superior. Although some combinations of cytotoxic agents     provide a small progression-free survival advantage, none has demonstrated an OS advantage,     and toxicity is generally greater than for single agents. At present, there is no standard     for this treatment setting. New treatments that could delay disease progression without     systemic toxicity would represent a significant advancement.   "
84846|NCT02175433|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or     relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be     assessed.   "
84847|NCT02175420|"     The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.      Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have     non-specific effects on the innate immune system and is in epidemiological studies associated     with reduced mortality due to infectious diseases.      Several studies have shown that BCG can boost the effect of other vaccines. The present study     aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV)     and to assess the non-specific effects of BCG on the innate immune system at early timepoints     by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.      The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better     vaccination result in terms of antibody production will be accomplished against typhoid fever     due to the effects of BCG on the innate immune system.   "
84848|NCT02175407|"     The purpose of this study to explore the effect of multiple oral doses of itraconazole on the     pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will     also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in     combination with itraconazole.   "
84849|NCT02175394|"     The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the     steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the     components of Microgynon®   "
84850|NCT02175381|"     The investigators propose to study the safety and efficacy of the combination of Carboplatin     plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.   "
84857|NCT02175290|"     Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA-3) is the most common     dominant ataxia. The genetic cause of this late-onset degenerative disorder is the expansion     of a (CAG)n tract located in the exonic region of the ATXN3 gene. In 1994 the first case of     MJD among the Yemenite Jewish subpopulation living in Israel was published. The puropse of     this study is to describe the clinical phenotype and genotype of the Yemenite Jewish     subpopulation with MJD living in Israel   "
84858|NCT02175277|"     This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160     study for the treatment of anaemic subjects with MDS. Subjects that complete the     active-treatment period of the darbepoetin alfa MDS 20090160 study and meet the eligibility     criteria may be enrolled into this study to continue treatment of darbepoetin alfa for up to     73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first.   "
84859|NCT02175264|"     In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the     occurrence of novo mutations (dominant or recessive). Our objective is to test this     hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations     through whole exome sequencing in a homogenous group of patients.   "
84860|NCT02175251|"     Auditory Hallucinations (AH) are experienced by 50 to 70% of subjects with schizophrenia.     Almost a quarter of patients are medication resistant to such symptoms. The application of     rTMS at low frequency in the left temporoparietal cortex reduces AH. A pilot study reported     successful treatment of AH with high frequency rTMS. rTMS (20Hz) should be a shorter and an     easier treatment for out-patients with schizophrenia compared to low stimulation treatment.   "
84861|NCT02175238|"     The primary objective of this trial is to investigate the relative bioavailability and     pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with     and without food in healthy male subjects.   "
84862|NCT02175225|"     The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate,     improves the outcome of patients with brain hemorrhage.      The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of     sufficient promise to improve outcome before pursuing a larger clinical trial to examine its     effectiveness as a treatment for intracerebral hemorrhage.   "
84863|NCT02175212|"     The present study is a phase III randomized and multicentric trial evaluating the potential     additional impact effect of two years adjuvant androgen deprivation when combined with     neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk     prostate cancer patients. Stratification will be performed by prognostic factors and by     participating institution.   "
84864|NCT02175199|"     The purpose of this study is to evaluate the comfort of color contact lenses in a population     of clear contact lens wearers who have an interest in wearing color contact lenses.   "
84866|NCT02175173|"     This surveillance's objectives are        1. Unknown adverse reactions        2. Incidences of adverse drug reaction        3. Efficacy during long-term administration        4. Factors considered to have effect to safety and effectiveness        5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and          central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)   "
84867|NCT02175160|"     Several studies exist on patient performance in drive simulators especially around and after     surgery. Recommendations concerning the ability to drive preoperatively are based on these     studies, which generated their data using drive simulators. However, in all the datasets     driving performance remains highly individual. Since a drive simulator is not readily     available in normal general practitioner surgeries it would be helpful to have convenient     clinical tests to evaluate a patients individual ability to perform an emergency stop. This     study aims at evaluating different possibilities how such performance might be predicted.     Patients with knee osteoarthritis and patients who have received total knee arthroplasty are     tested clinically and their results are compared with the gold standard experiment - a drive     simulator.   "
84868|NCT02175147|"     Rationale: Palliative care integration in treatment pathways, palliative care networks and     institutional collaborations in health services delivery seems a promising approach reducing     fragmentation and discontinuity. Integrated Palliative Care (IPC) approaches in Europe are     largely unknown and under-investigated. The investigators aim is to explore experiences of     patients with advanced cancer, Chronic Obstructive Pulmonary Disease (COPD) and Chronic Heart     Failure (CHF), family and professional caregivers within with IPC. This includes perceived     quality of life, quality of care, burden/rewards of care giving, symptoms and collaboration     between caregivers in the patient's care network.      Objectives: To investigate how patients with advanced cancer, COPD and CHF, their family and     professional caregivers within a selection of IPC initiatives in Belgium, Germany, Hungary,     The Netherlands and United Kingdom experience care delivery in the last phase of disease.        -  To investigate what opinions patients and family caregivers have on the (continuity and)          quality of care delivered        -  To investigate how patients rate their symptoms and quality of life        -  To investigate how family caregivers rate their burden / rewards of care giving        -  To investigate how the care network of the patient is organised with respect to the          type, properties and quality of relationships between patients and family / professional          caregivers      Study design: Longitudinal multiple embedded case study.      Study population: Adult patients with advanced cancer, COPD, and CHF under the care of IPC     initiatives in five participating countries, their family and professional caregivers. The     investigators aim to enroll up to 288 patients, 288 family caregivers and 192 professional     caregivers in total.      Study parameters: Experiences with IPC initiatives, quality of care, quality of life,     perceived symptoms, perceived collaboration between professional caregivers, burden and     rewards of care giving.      Methods: Semi-structured interviews, patient diary, Social Network Analysis and the following     questionnaires: Palliative care Outcome Scale; Canhelp Lite, Caregiver Reaction Assessment.     Patients and family caregivers will be followed over 3 months at 4 consecutive contact     points. The diary (containing two questions) will be kept weekly by patients. There will be     group or individual interviews with professional caregivers.      Analysis: The overall analysis will involve a synthesis of the qualitative and quantitative     data. For more information see Detailed Description.   "
84869|NCT02175134|"     The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent on     invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for     diagnosing TBP shows has given promising results. The investigators thus created a 2-step     algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for     differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a     rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the randomized     controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic     biopsy for the diagnosis of TBP in patients with suspected TBP.   "
84870|NCT02175121|"     This study is going to assess the safety and tolerability of PF-06291874 in adults with Type     2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control     in these subjects.   "
84872|NCT02175095|"     Regorafenib is approved in the treatment for metastatic colorectal cancer patients who have     been progressed after standard therapies, however, there has not been a predictive biomarker.     The investigators designed this study to investigate whether [18F]FLT-PET might paly a role     as a predictive imaging biomarker of treatment responses to regorafenib.   "
84873|NCT02175082|"     The purpose of this study is to assess the effectiveness of a forced exercise aerobic     exercise program, utilizing a cycling activity, on specific gait parameters and balance in     individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control,     evaluator blinded. Subjects: Twenty four patients with idiopathic PD Hoehn and Yahr (H&Y)     stage II or III. Intervention: Participants randomly assigned to one of two exercise groups,     forced exercise or self selected exercise, on cycling machine three times a week for 8 weeks.     Both groups to exercise at same aerobic intensity level to keep heart rate at 60-80% heart     rate max. Outcomes: Gait parameters of step length, width, and variability as measured by the     GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise tolerance via Patient     Reported Outcomes Measurement Information System (PROMIS) scale.   "
84874|NCT02175069|"     Interscalene plexus block is a widely used technique to provide anesthesia and analgesia for     surgery at the upper extremity (shoulder and upper arm); it is standard-of-care in many     institutions worldwide. Local anesthetic is being injected around the nerves supplying the     arm (Plexus brachialis) at a specific location in the arm (between the scalenus muscles, thus     called interscalene plexus block). The optimal volume of injection with regard to efficacy,     safety and avoidance of untoward effects has been subject to intense debate for a long time.     In spite of evidence that small volumes (between 5 and 7 mls) are effective for adequate     postoperative analgesia, larger volumes up to 40 mls are still frequently used in many     practices. However, with the use of such large doses, adverse events are known to occur with     increased frequency, including paralysis of the diaphragm or spread of local anesthetic to     the spinal cord.      This study is intended to help evaluate the effects of small or larger injection of local     anesthetic around the brachial plexus, and to correlate the distribution with clinical     efficacy, block duration, and possible side effects. It is a randomized, controlled,     observer-blinded trial; patients undergoing shoulder or upper arm surgery will be randomly     allocated to receive either 5mls or 20mls of local anesthetic for their interscalene plexus     block. Magnetic resonance imaging will be performed immediately afterwards, followed by a     series of neurological exams during the hospital stay. Test of lung function (spirometry) and     ultrasound of the diaphragm will be used to evaluate effects of the block on respiratory     mechanics.   "
84875|NCT02175056|"     The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind),     Active Controlled(Open-label), Dose-escalation.   "
84939|NCT02174224|"     The purpose of this study is to determine if a hospital-based violence intervention programs     can make sustainable behavior changes in at-risk youth using two key components, brief     intervention at the hospital bedside and case management.   "
84940|NCT02174211|"     To study the effect of pars plana vitrectomy and posterior vitreous detachment on the     intravitreal pharmacokinetics of ranibizumab   "
84876|NCT02175043|"     1. Purpose of the study      1) To compare clinical outcome, procedure time, complication rate of persistent atrial     fibrillation patients between conventional additional linear ablation and additional complex     fractionated atrial electrogram targeted catheter ablation.      2. Scientific evidence of the study        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed          significant reduction of mortality.        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus          non-drug therapy such as catheter ablation is developed.        3. catheter ablation has been performed for 10years world-wide, and showed superior          treatment outcome compared with drug therapy.        4. However, there are no consensus for proper ablation strategy in longstanding persistent          atrial fibrillation.        5. additional ablation make extent of myocardial injury and paradoxically increase          recurrence rate, thus still controversial.        6. Therefore, we will compare conventional linear ablation with additional complex          fractionated atrial electrogram targeted catheter ablation.      3. Methods        1. Treatment of All patients with atrial fibrillation is performed according to the          standard treatment guideline of atrial fibrillation.        2. there is no additional blood sampling, imaging study, or any other invasive procedure          according to the inclusion of the study.      4. study contents        1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation             -  compare conventional linear ablation with additional complex fractionated atrial               electrogram targeted catheter ablation. both strategies are conventional ablation               strategies being performed world-wide.        2. compare complex fractionated atrial electrogram before and after linear ablation.   "
84877|NCT02175030|"     This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the     most effective method of emergency contraception vs. the levonorgestrel IUD, the most     preferred IUD which has never been tested as an emergency contraceptive. This research has     the potential to increase use of highly effective contraception in a high-risk population and     lower the persistently elevated rate of U.S. unintended pregnancy.   "
84878|NCT02175017|"     The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects     with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy     and resistant to a platinum-based chemotherapeutic regimen.   "
84879|NCT02175004|"     This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in     patients with Familial Amyloid Polyneuropathy.   "
84880|NCT02174991|"     A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and     0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled IOP who are     facing surgical intervention. Patients will be treated for 6 months in this initial trial.      B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the     necessity of surgical intervention.   "
84881|NCT02174978|"     The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed     primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is     a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by     GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the     immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The     immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to     safety.   "
84882|NCT02174965|"     The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.)     femoral component has a predictable and stable migration pattern (mean migration of the     femoral component in three-dimensions,in mm) over a three year period, compared to a     conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study     are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and     stable migration pattern over a three year period and to measure the linear wear of femoral     head into the ECIMA Highly Cross-linked polyethylene.   "
84916|NCT02174523|"     To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40     mg lurasidone in healthy Chinese subjects.      To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone     in healthy Chinese subjects.   "
84917|NCT02174510|"     To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral     administration of different doses in healthy Chinese subjects.      To evaluate the safety and tolerability of lurasidone after single oral administration of     different doses in healthy Chinese subjects.   "
84883|NCT02174952|"     Therapist-led parenting interventions have been shown to reduce symptoms of attention deficit     hyperactivity disorder (ADHD) and are recommended as a first line treatment for school age     children with ADHD. However, parenting interventions can be costly and impractical for     parents due to factors such as time constraints and travelling costs. A self-help parent     training manual has been developed and initial results have shown moderate reductions in ADHD     symptoms, indicating that whilst self-help may offer a cost effective alternative to     therapist led parent training interventions, it may not be sufficient to treat ADHD alone.     This study therefore aims to compare the efficacy and additional benefits of the self-help     intervention plus treatment as usual including pharmacotherapy with a control treatment as     usual group . Families with a child aged 6-10 with a clinical diagnosis of ADHD will be     recruited to the study via referrals from community paediatricians and child and adolescent     mental health services. After gaining informed consent subjects will be randomised to     self-help plus Treatment as usual (TAU) + or TAU (control). Those allocated to TAU+SH will be     issued with the self-help manual and an introductory DVD to highlight key aspects of the     intervention. Self-help intervention will last for 12 weeks. Data will be collected via     standardised questionnaires completed by the parent, teacher and child and a recorded speech     samples from the parent. Data will be collected at three time points; pre-intervention,     post-intervention (12 weeks) and as a long term follow up (28 weeks). After completing the     trial, qualitative data will be collected about participants' experience of self-help     intervention.   "
84884|NCT02174939|"     1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely          associated with coronary risk factors and atherosclerotic diseases such as coronary          artery disease (CAD) and cardiovascular high risk.        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of          cilostazol on human early EPCs and endothelial function as well as the potential          mechanisms of action in patients with CAD and cardiovascular high risk.   "
84885|NCT02174926|"     The purpose of this study is to find out whether elective sigmoid resection will improve     quality of life compared to conservative treatment with lifestyle guidance and fiber     supplement in patients with a recurrent or complicated diverticulitis.   "
84886|NCT02174913|"     BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS     can reduce total propofol dose when being used with TCI.The objective is to compare awakening     time after spine surgery between using clinical signs and bispectral index (BIS) guided     target controlled infusion(TCI) of propofol in patients having neurophysiologic monitoring.   "
84887|NCT02174900|"     The purpose of this study is to evaluate the tolerability and safety of increasing doses of     primaquine in combination with artemether-lumefantrine in G6PD deficient males with an     asymptomatic P. falciparum malaria infection.   "
84888|NCT02174887|"     The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold     standard since the end of the 90s' is gemcitabine; unfortunately all trials testing     combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to     demonstrate any superiority over gemcitabine monotherapy.      In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel in     patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an impressive     response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week for 3 weeks,     every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy, nausea,     haematological side effects). This efficacy can be related to an improvement of gemcitabine     delivery to the tumor bed, as shown on preclinical studies: the response rate in xenografts     was better with the combination; this improvement was associated with an increase of     intratumoral gemcitabine concentration in mice receiving the combination when compared to     mice receiving gemcitabine alone. This might be associated to modifications of peritumoral     stroma with reduction of stromal content and increase in dilated vessels.      The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine     induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor     and of liver metastases after 2 cycles of treatment by comparison to baseline.   "
84889|NCT02174874|"     In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED)     with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron     Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral     Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less     vomiting within 15 minutes of administration than those receiving Ondansetron OS.   "
84890|NCT02174861|"     To assess the long-term safety and efficacy of AMG 334 .   "
84891|NCT02174848|"     Patients with PKAN will be treated with the iron chelator deferiprone for 18 months. Only     patients who have completed the earlier study TIRCON2012V1 (a double-blind placebo-controlled     trial in which participants were randomized to receive either deferiprone or placebo for 18     months) are eligible to enroll.   "
84892|NCT02174835|"     To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786     (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy     volunteers.   "
84893|NCT02174822|"     To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786     (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and     between AVP-786 and duloxetine.   "
84918|NCT02174497|"     This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day     bowel preparation in a pediatric population. Limited data is available in this regard, and     this study supports the use of a one-day bowel preparation, as this is both safe and     effective.   "
84919|NCT02174484|"     The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature     (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm,     sensing and capture, and thus to detect anomalies that may deserve a clinical action.      PREMS is a non-interventional, prospective, and multicenter study. The primary objective is     to assess the added clinical value of periodic IEGMs, based on the rate of patients with a     rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring     (HM) and non detectable so obvious on the other parameter set offered for the remote     follow-up.   "
97767|NCT02006485|"     The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in     combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with     advanced hematologic malignancies   "
84894|NCT02174809|"     Excess weight gain in pregnancy is linked to a number of adverse outcomes for mothers and     their offspring, and in 2011, 59 % of women in Nova Scotia gained weight in excess of     recommendations. A number of factors influence how much weight a woman gains, including lack     of knowledge, age, the number of previous pregnancies she's had, smoking, ethnicity, income,     and education. Although a clinician's advice also plays a role, simply giving advice does not     necessarily translate into patient behaviour change. On the other hand, advice that is given     through a patient-centred approach is significantly associated with increased patient     acceptance of and adherence to recommendations, and increased intentions and attempts at     behaviour change. In addition, this approach has been shown to decrease costs to the health     care system. Patient-centredness can measured from the perspective of the clinician, an     observer, or the patient. Research suggests that the patient's perspective of     patient-centredness is the perspective most significantly associated with improved health     outcomes.      Clinicians avoid discussing weight-related matters for a number of reasons, including a lack     of time and general discomfort in raising the subject. There are some tools that can address     some of these barriers, and example being the 5As of Obesity Management. This tool is based     on principles of behaviour change science and patient-centredness. Pilot data on the use of     this tool showed a two-fold increase in the initiation of weight-related discussions between     clinicians and their patients. Our team was instrumental in the development, dissemination     and initial evaluation of this tool, and Dr. Piccinini-Vallis has recently led a national     multidisciplinary endeavor to adapt it to pregnancy, which has resulted in the 5As of     Healthy Pregnancy Weight Gain tool. It is now time to evaluate whether the use of this tool     is acceptable to clinicians and whether its use translates into any patient outcomes.   "
84895|NCT02174796|"     this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or     orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction     (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the     cardiac output difference before and after intervention, measured by transthoracic     impedancemetry, during an exercise stress test   "
84896|NCT02174783|"     Many metabolic complications can develop after liver transplant including: diabetes, high     blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the     safety and effect of 2 well known and established diet regimens on the people who had a prior     liver transplant and investigate whether it helps with the control of these comorbidities.   "
84897|NCT02174770|"     Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads     to beneficial changes in muscle at low resistance and minimal stress on the nearby joint.     This novel resistance training has the potential to greatly improve extremity muscle strength     gains for rehabilitation patients who are unable for medical reasons to perform high     resistance exercise. Our study will explore this with specific rehabilitation populations:     post-operative knee scopes, post-operative anterior cruciate ligament (ACL) reconstruction     patients who have acute post-operative changes in thigh muscle function and chronic thigh     weakness. The primary outcome is to achieve accelerated functional thigh recovery with     outcome measures including thigh strength, validated questionnaires, and validated functional     testing. Occlusion training can enhance rehab patients outcomes, reduce the cost of care, and     improve the skills and efficiency of care providers.   "
84898|NCT02174757|"     Periodontitis is a multifactorial disease that can lead to the destruction of supporting     tissues of the teeth resulting in pocket formation, recession or both. Since the primary     etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm,     efforts for disease prevention and treatment are mainly focused on pathogen reduction and     strengthening of epithelial barrier, thus contributing to decreased susceptibility to     infection. Due to emergence of antibiotic resistance and frequent recolonization of treated     sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced     to periodontal disease. The need was fulfilled by the introduction of Probiotics and     Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning for     life are microorganisms proven to exert health promoting influences in humans and animals.     Food and Agriculture Organization and WHO have stated that there is potential for probiotic     foods to provide health benefits and that specific strains are safe for human use.   "
84899|NCT02174744|"     The pain of the elderly is often trivialized and ignored in spite of its high frequency: the     chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in     institution and 80 % of this population at the end of life.      The evaluation of pain appeals to the same strategy as to the younger subject but with some     specificities, related more to the pathologies associated with the ageing than to the real     age. For that purpose, the investigators have self-assessment scales as the Numeric Pain     Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a     bias because, some patients do not express spontaneously their pain.      So behavioural scales were elaborated to solve the difficulties of detection and to care the     pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be     completed) whose objective is the observation of behavioural changes caused by the acute pain     in elderly having communication disorders. The Doloplus® scale (30 items which allow in few     minutes a good evaluation of pain) whose objective is the observation of behavioural changes     caused by the chronic pain in elderly having communication impairments.      In practice, because of its popularity, the Algoplus® scale is widely used out of the     specificity in which it has been validated. Practitioners, worried about this misuse,     suggested to Doloplus® group, to test the concordance between the two behavioural scales in     order to develop recommendations more targeted. The risk is that the use of the Algoplus®     scale may underestimate pain that would have been detected by Doloplus® scale, and lead to     under-treatment or non-treatment of pain in elderly having communication disorders.      This study aims to establish the concordance between these two scales to generate advices and     recommendations to assess efficiently the pain in this vulnerable population.      The main objective of this study is to assess whether the use of Algoplus® scale is in good     concordance with Doloplus® scale.      The secondary objective of this study is to assess the concordance with different levels of     Algoplus® pain scale: (0-1), (2-3), (4-5).   "
84900|NCT02174731|"     The purpose of this study is to evaluate the safety and efficacy of roxadustat compare to     epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.   "
84901|NCT02174718|"     A clinical need exists for non-oral vitamin D administration. This study is designed to test     a new proprietary transdermal system. It is looking to see if this new system will safely and     successfully deliver vitamin D3 to humans.   "
84902|NCT02174705|"     This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to     sugar water for reducing vaccine injection pain in infants.   "
84920|NCT02174471|"     Aortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and     the Western world. Surgery for severe AS prior to symptom onset is controversial.     Conventionally changes in valve area and gradient are used to time intervention but     myocardial changes may be more predictive of surgical need.      This study aims to elucidate the role of diffuse myocardial fibrosis as a prognostic marker,     implementing a novel, non-invasive MRI technique to measure it.      Design: The investigators will measure diffuse myocardial fibrosis in 150 patients with     severe narrowing of the aortic valve before and one year after valve replacement. Expected     outcomes: Diffuse myocardial fibrosis measured by MRI scanning will predict outcome after     surgery in aortic stenosis. Anticipated Health Benefits: Identify patients with higher post     operative morbidity and mortality, who may benefit from earlier valve replacement.   "
84903|NCT02174692|"     The aim of this study is to understand how healthy muscle repairs in response to eccentric     exercise by evaluating functional, metabolic and molecular measures. Furthermore, this study     will aim to understand the repair mechanisms in elderly healthy muscle following eccentric     exercise by evaluating the same measures and highlighting age-related differences in repair     mechanisms which may account for the age-related loss in muscle mass. It is hypothesised that     elderly muscle will have a lesser/ blunted repair process compared to young muscle.      To meet the aims of this study and to answer the hypothesis, this study protocol is as     follows:      Baseline functional, metabolic and molecular values are obtained via functional testing and a     muscle biopsy. Participants then perform eccentric exercise designed to induce functional     decline and muscle soreness and the contralateral leg performs concentric exercise which     isn't designed to induce soreness or functional decline. Using a time-course, various     metabolic and molecular measures are taken prior to and up to 7 days post exercise to     understand the mechanisms underlying muscle repair. In addition the use of a novel amino acid     tracer (D2O) will allow for synthesis measures over the duration of the study rather than the     typical tracer techniques which only capture ~12 hours of synthesis.   "
84904|NCT02174679|"     To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine     tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.   "
84905|NCT02174666|"     The aim of the project is to execute a double-blind, parallel, randomized 12-month     intervention trial on postmenopausal women with osteopenia (low bone mineral density), in     order to determine the effects of daily intake of fermented red clover (RC) extract on     estrogen dependent bone mineral resorption when compared to placebo. Both groups will recieve     equivalent daily calcium, vitamin D and magnesium supplements. The project will also assess     whether bioactive compounds in RC can reduce the risk of developing cardiovascular disease.   "
84906|NCT02174653|"     The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term     (4 months) medication. The protective effects of EPs®7630 and its effects during a cold     episode will also be studied.   "
84907|NCT02174640|"     The primary objective is to test if acute supplementation with Coffee would improve     antioxidant status, following consumption of a pro-oxidative high carbohydrate, high fat meal     in over weight/ obese humans.      Secondary objective is to determine the ability of coffee to modify postprandial inflammation     in overweight/ obese humans.   "
84908|NCT02174627|"     The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment     of anemia in patients with chronic kidney disease not on dialysis.   "
85066|NCT02172573|"     The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole)     tablets administered in combination with L-dopa in patients with Parkinson's disease using     placebo and bromocriptine tablets as comparators in a double-blind design (phase III     comparative study).   "
84909|NCT02174614|"     The investigators are conducting a randomized clinical trial of rapid abstinence initiation     and cognitive control training as a precursor to our new web-based version of the CBT4CBT     (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its     effectiveness relative to standard outpatient counseling at the Midwestern Connecticut     Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and     inhibitory control and the computer-based training program (CBT4CBT) focuses on teaching     basic coping skills, presenting examples of effective use of coping skills in a number of     realistic situations in video form, and providing opportunities for patients to practice and     review new skills while receiving cocaine abuse treatment.   "
84910|NCT02174601|"     After written consent for participating in clinical research studies, all clinical studies     conducted to in the one day. The investigators will ask and record about bowel cleansing     state in all patients who performed colonoscopy. There is no additional cost and the expected     complications.      Based on answer, the investigators will develop a prediction model for inadequate bowel     preparation and prove validation. This model can take the additional measures to subjects     predicting improper cleansing. It can contribute to improve the accuracy of the test and     reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost     savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a     improvement of the quality of management   "
84911|NCT02174588|"     Since introduction in 1989, propofol has gained wide acceptance for sedation during     endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not     established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation     (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this     study, the investigators want to compare the patient satisfaction with EGD following balanced     propofol sedation (BPS) versus propofol sedation alone.   "
84912|NCT02174575|"     -  It has been shown that patients who undergo liver resection surgery are at high risk for          postoperative acute kidney injury (AKI).        -  Sevoflurane may increase the risk for postoperative AKI because of production of          compound-A.        -  Therefore, we have planned to investigate the effects of different anesthetic agents on          postoperative renal function.        -  Patients undergoing liver resection surgery are randomized into 2 groups.        -  One of the groups receives sevoflurane and the other group receives desflurane.        -  Blood and urine specimen are sampled both pre- and postoperatively, and several          biomarkers are compared between the groups.   "
84913|NCT02174562|"     This research aims to help older African Americans with diabetes and mild memory problems     improve how they take their medications and control their diabetes. This may preserve their     independence and health, prevent cognitive and functional decline, and reduce health care     costs. As the population ages and becomes more racially diverse, finding ways to achieve     these outcomes has great public health importance.   "
84914|NCT02174549|"     This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating     agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer     patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4     nodules are eligible. Tirapazamine will be given by intravenous infusion in the first two     cohorts and then switched to intra-arterial injection before embolization in subsequent     cohorts. Treatment effect is evaluated by MRI based on modified RECIST criteria. Repeat     treatment is necessary only if disease progression. Each patient is allowed to have up to 6     treatments in a 18-month period.   "
84915|NCT02174536|"     A prospective double blind randomized study comparing placenta derived decidual stromal cells     with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It     is hypothesized that the decidual stromal cell therapy will be superior to placebo.   "
84921|NCT02174458|"     Body contouring (BC) surgery after major weight loss (MWL) requires extensive and multiple     procedures. Yet, there are inconsistent data regarding the outcome after BC procedures. The     aim of this study is to investigate the outcome from patients who elect to have BC procedures     after MWL treated at a single metropolitan tertiary referral center.   "
84922|NCT02174445|"     This is an open-label, multicenter, randomised phase 3b clinical trial of Imatinib 400 to 800     mg daily versus Nilotinib 300 mg two times daily in chronic phase CML patients with confirmed     MMR without MR4.5   "
84923|NCT02174432|"     The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER     tablets during a treatment period of up to 50 weeks.   "
84924|NCT02174419|"     The primary objectives of the study are to evaluate the effects of two doses of nalbuphine     HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in     patients with prurigo nodularis and to evaluate the safety and tolerability in the study     population.   "
84925|NCT02174406|"     The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis     (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and     DBT.   "
84926|NCT02174393|"     Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults.     Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions,     and depending on the skin type, significant erythema (redness) or post-inflammatory     hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the     aforementioned types of lesions. Pharmacologic management is essential, but safe procedural     therapies are also necessary specifically with darker skinned individuals.      Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using     a micro-needling device, which is safe and effective in causing micro-wounds into the     dermis thereby initiating wound healing followed by collagen production. This is an ideal     treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin     types . Currently there are very few studies evaluating the safety and efficacy of     microneedling and chemical peels in skin types III-VI.      The aim of this study is to evaluate the effects of the combination of microneedling and     chemical peel for the treatment of acne scars in skin types III-VI.   "
84927|NCT02174380|"     The purpose of this study is to determine the effectiveness and cost-effectiveness of a new     population-based active case-finding program among adult household contacts of new infectious     TB cases to detect active TB cases in the largest district, Lima, Peru.   "
84928|NCT02174367|"     • Main objectives and outcome measures.        1. Establish prevalence of and factors contributing to fatty liver disease and liver          fibrosis in patients with psoriasis.           Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy          or non-invasive tests of fibrosis including transient elastography, ultrasound, serum          markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).        2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely          transient elastography, standard liver function tests and P3NP.        3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic          syndrome on response to treatment in patients with psoriasis.      Data on co-morbid disease collected through questionnaires and review of medical records.     Response to treatment assessed using psoriasis area and severity index (PASI) physician     global assessment (PGA) and dermatology life quality index (DLQI).        -  Study population: 380 patients with moderate to severe psoriasis will be prospectively          recruited to the study.        -  Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine          Smith        -  Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St          Thomas Hospitals Trust   "
84929|NCT02174354|"     Methotrexate (MTX) is widely prescribed to treat inflammatory conditions including psoriasis,     where it is the recommended first-line systemic therapy in moderate-to-severe disease.     Approximately 40% of patients with psoriasis have a sub-optimal response to MTX and a     significant number experience side effects that may include deranged liver enzymes. There is     currently no validated test to predict how patients with psoriasis will respond to MTX, in     terms of disease outcome and/or toxicity, or to guide dose escalation in this group.   "
84930|NCT02174341|"     This test is to be collected during the dengue outbreak samples, including samples back in     the past and forward to close the case, investigating the prevalence of serum Chikungunya     virus infection, and against those suspected dengue fever, Chikungunya disease-related tests     conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to     detect Chikungunya virus and then develop.   "
84931|NCT02174328|"     The main objective of this trial is to study the occurrence of preeclampsia in recipients of     donated oocytes receiving aspirin at an early stage during pregnancy and to compare the     results with those obtained in patients receiving placebo.   "
84932|NCT02174315|"     This study examines the impact of a culturally tailored version of contingency management     treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives.     Participants will be recruited from addiction treatment agencies and throughout the     community. Those who complete a 4 week induction period will be randomized to receive 12     weeks of contingency management or a non-contingent control condition. Individuals will then     be followed for an additional 3-months to assess the long term efficacy of the treatment.   "
84933|NCT02174302|"     Comparison of Images of the same area in the bladder in four different SPIES modalities on a     tablet computer. Participants are asked to delineate the area on the image suspect for     malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s)     is/are captured. Time to start the drawing and total time per image are captured. Hereafter,     an judgement of Image quality is asked on a scale of 0 to 10, 0 being worst possible and 10     being best possible.   "
84957|NCT02173990|"     The PULsAR trial is an international, investigator-initiated, single arm open-label phase II     study. The aim of this study is to measure the clinical activity of the combination     FOLFIRI-aflibercept in an homogeneous group of patients with metastatic colorectal cancer,     and treated with a FOLFIRI-aflibercept regimen as first line treatment.   "
85039|NCT02172924|"     The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell     therapy for graft versus host disease after allogeneic hematopoietic stem cell     transplantation. The hypothesis to be tested is that the cells are safe to infuse and that     they have a positive clinical effect.   "
84934|NCT02174289|"     Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart     failure with well documented benefits in symptom improvement and reduction of morbidity and     mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the     recommended indications. Lack of clinical response may be the result of imperfect left     ventricular lead placement in the veins around the heart with conventional techniques.     Optimum lead placement may constrained by coronary venous anatomy and may overlie scarred     heart muscle or may not be at the site of latest electrical depolarisation. In a further 10%     of patients, conventional left ventricular lead placement is not possible for other technical     reasons.      Left ventricular endocardial lead placement may overcome the limitations and allow placement     to be guided by echocardiography, electrical mapping and the pattern of heart muscle     scarring.      We aim to investigate if targeted left ventricular endocardial lead placement improves     exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency     and biochemical markers of heart strain. Each parameter will be assessed independently and as     part of a composite cardiac performance score.      Patients with heart failure will be enrolled who require an endocardial left ventricular lead     on clinical grounds as either conventional left ventricular lead implantation has technically     failed or they have clinically non-responded to CRT.   "
84935|NCT02174276|"     This study is to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with     chronic hepatitis B infection (CHB) and who are currently not on treatment. Participants will     be randomized to receive tenofovir disoproxil fumarate (TDF) alone or GS-4774 plus TDF for 20     weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and     will be followed for an additional 28 weeks. Following completion of the 48 week study     period, all participants will be eligible for a 3 year registry study.   "
84936|NCT02174263|"     This phase II trial studies how well tocilizumab works in treating chronic graft-versus-host     disease (GVHD) in patients that have not responded to treatment after at least two prior     therapies. Tocilizumab blocks a protein that stimulates the body's immune system. By blocking     this protein, the investigators may reduce the symptoms of chronic GVHD.   "
84937|NCT02174250|"     The purpose of this study is to test whether Rifampin affects blood levels of istradefylline     in humans. Rifampin could possibly decrease istradefylline levels.   "
84938|NCT02174237|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and     pharmacodynamics of single and multiple ascending oral dose LNP1892 in healthy males and     female subjects   "
84941|NCT02174198|"     This study compares two ways of placing a dental implant on the day of tooth extraction. One     method will place a additional bone graft (derived from bovine bone) and the other group will     not have the graft placed. Both groups will be restored at the same time with an immediate     crown.      The investigators will be researching and comparing the changes in gum level that occur after     each surgical method, as well as changes in jaw width where the implant is placed.      The investigators will enroll 16 patients per group. The patients will be followed for 3, 6,     and 12 months post-immediate implant placement to observe healing.   "
84942|NCT02174185|"     The aim of this study is to compare the health-related quality of life (HRQoL) between     patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The     investigators plan to use validated HRQoL questionnaires to learn about how the different     urinary diversion operations affect the HRQoL of people living with bladder cancer. The     findings from this study may help doctors and patients choosing the proper operation type.   "
84943|NCT02174172|"     This global, multicenter, open-label study will evaluate the safety and tolerability of     atezolizumab in combination with other immune-modulating therapies in the treatment of     selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A)     will focus primarily on participants with advanced or metastatic non-small cell lung cancer     (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon     alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus     bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma     (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll     participants with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma     (HNSCC). Atezolizumab will be administered as intravenous (IV) infusion every 3 weeks (q3w).   "
84944|NCT02174159|"     The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral     activity of a single dose of MK-8507 in antiretroviral therapy (ART)-naive, HIV-1 infected     participants. The hypothesis tested in the study is that at a safe and well-tolerated dose,     MK-8507 has superior antiretroviral activity to a historical placebo control, as measured by     change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.   "
84945|NCT02174146|"     1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?        2. Does their level change after periodontal therapy?   "
84946|NCT02174133|"     End stage heart failure is characterized by a critical inability of the heart to meet the     organism's blood demand even under resting conditions. Heart transplantation (HTx) is the     established therapeutic approach in the treatment of end stage heart failure and still the     gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital     therapeutic option to temporarily or permanently assist the failing circulation. The     hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The     aim of the study is to investigate the effect of LVAD implantation compared to heart     transplant (HTx) on micro- and macrovascular function in patients with end stage heart     failure.   "
84947|NCT02174120|"     To explore the application of target controlled infusion of etomidate combined with propofol     in the maintenance of anesthesia during brain surgeries.   "
84985|NCT02173626|"     An eight week mindfulness training for physicians in a community hospital setting, largely     administered through web-casts, will decrease stress and burnout, increase job satisfaction,     and develop lasting mindfulness skills in the participants.   "
84948|NCT02174107|"     The purpose of this study is to evaluate cost-utility analysis in order to provide     recommendations to French decision-makers between vertebroplasty and radiation therapy in     Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The     object of this study would be to expand the use of vertebroplasty.      Moreover, this study assess to the strategy impact on the pain control reduction and     functional preservation. In fact, analgesic effect is achieved differently depending on the     procedure used.Eligible patients will be recruited and registered consecutively. Patients     will be randomly,      This is a health-economic multicenter, prospective, randomized with stratification according     to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :        -  Arm A: Percutaneous vertebroplasty        -  Arm B: External radiotherapy      This is an open-label study. The expected total study period is 2.5 years (enrolment: 2     years, patient follow-up: 6 months). A total number of 304 patients with spine metastases     will be recruited (152 patients/arm).   "
84949|NCT02174094|"     The purpose of this study is to investigate the effect on the frequency of tonic-clonic and     clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of     treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.   "
84950|NCT02174081|"     ARDS is a severe disease, it's important to predict the incidence of ARDS.   "
84951|NCT02174068|"     Pain remains the leading cause of consultation. Despite a wide therapeutic arsenal, a     significant percentage of patients disclaim little or no pain relief with common analgesics,     specific or not their type of pain. This is especially true in cases of chronic pain, and     current treatments are associated with many side effects. A need for therapeutic innovation     is needed. Paracetamol is currently the most widely used analgesic worldwide but despite its     excellent safety, its analgesic effect is limited from moderate to severe pain. Many     analgesic drug combinations include paracetamol, recently the co-administration of     paracetamol and nefopam showed a supra-additive antinociceptive effect (Van Elstraete AC et     al. 2013). The development of a formulation associating paracetamol and nefopam first     requires searching a possible pharmacokinetic interaction between the two active substances     and assessing safety of this combination in healthy volunteers. No published studies     providing such information.   "
84952|NCT02174055|"     The purpose of this study is to develop an accurate and useful way of measuring older     patients' moods and reactions to the combined issue of cancer treatment and aging.   "
84953|NCT02174042|"     The aim of this retrospective study is to review and describe safety and efficacy of Tang     Ning Tong Luo capsule.   "
85031|NCT02173028|"     Patients will be treated according to the clinical practice of the participating centers and     to the international guidelines for the treatment of heart failure.The present analysis     provides a collection of data about the changes to drug therapy after the Cardiac     Resynchronization Therapy (CRT) procedure , and any signs and symptoms of intolerance to     prescribed medications.   "
84954|NCT02174029|"     When a person is put on a breathing machine the investigators think that the breathing     muscles can get weaker. The investigators are not sure how quickly this happens but in some     people this leads to problems when they try to breathe on their own without the breathing     machine. The diaphragm is at the bottom of a person's chest separating their lungs from what     is in their belly and it is a very strong muscle. In fact, it is main muscle that one uses     for breathing.      An ultrasound machine is a painless way to see what is happening beneath the skin. It is safe     and easy to do. Using an ultrasound the investigators are planning to measure how thick the     diaphragm is and how much it changes while a person is on a breathing machine in the ICU.      Getting a better understanding of this condition could lead to improved treatments that might     help support patients who require a ventilator for breathing.      The investigators hypothesis is that patients for whom the breathing machine is doing all of     the work of breathing, will have their diaphragm thickness gradually decrease and changing to     a breathing modem mode where they have to put in more effort the diaphragm thickness will     start increasing again.   "
84955|NCT02174016|"     This is a prospective pilot study evaluating the safety and feasibility of implementing the     ketogenic diet in children admitted to the pediatric intensive care unit with acute brain     injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies     suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is     impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in     clinical practice for the treatment of medication resistant epilepsy and is intended to     switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their     standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive low     carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be     detectable through serum tests and MRI spectroscopy studies of the brain within several days     of diet initiation, and that there will be a low incidence of side effects and adverse     events,      Measures of interest will include the incidence of kidney stones, excessive acidosis and     excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy     trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a     type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies     within the brain will be measured through MRI spectroscopy sequence which will be acquired at     the same time as a follow-up MRI brain study ordered for clinical purposes.   "
84956|NCT02174003|"     This protocol will allow for the implementation of a research registry pertaining to Whole     Body Hyperthermia (WBH) use in various subject populations. The primary objective of the     proposed study is to determine if WBH can have beneficial effects in various subject     populations currently experiencing numerous other comorbidities, and the duration of the     effect(s).      This protocol is intended to become a secondary resort for individual's interested in     receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming     from comorbidities other than depression (i.e. Fibromyalgia, Perimenopausal symptoms,     arthritis, etc). Due to the fact that no external research funding has been acquired for this     broad application this protocol is intended to charge a fee for cost covering purposes only.      The registry trial will not be limited to only include individuals with major depressive     disorder, however, this protocol will allow for an expanded use in all populations (while     still excluding subjects based on safety parameters). We will monitor subject's physiological     and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an     open fashion (no placebo/control condition). This registry study will include safety     assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.   "
84986|NCT02173613|"     The main objective is to evaluate the interest of the repeated measurement of procalcitonin     in patients with pulmonary infection to reduce the duration of antibiotic therapy in     comparison with a conventional clinical strategy.   "
84958|NCT02173977|"     The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation     (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation     characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible     multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist     protocol.      The investigators hypothesized that combining the stimulatory effect of GnRH agonists and     immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH     strategy for IVF patients, resulting in improved ART outcome.   "
84959|NCT02173964|"     1. Background             1. PET/CT (positron emission tomography/computed tomography) using FDG               (fluorodeoxyglucose) is widely used for evaluation of cancer patients.             2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.             3. There is no widely-accepted method to reduce the bowel FDG uptake.        2. Purpose             1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce               bowel uptake of FDG.             2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.             3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel               contraction during PET/CT acquisition.        3. Method             1. Intervention versus control: administration of single tablet of pinverin (50mg)               perorally versus simple water (~100mL).             2. Timing of administration: At the time of FDG injection. PET/CT images will be               acquired 1hr post FDG injection.        4. Primary outcome             1. SUV (standardized uptake value) difference between pinverin administered patient               group versus control group.             2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in               mCi/mL) x (body weight in g) / (injected radioactivity in mCi)   "
84960|NCT02173951|"     A prospective randomized study on Safety, Tolerability and Efficacy of oral Low dose DFP (50     mg/kg/day) in minimally transfused B-TM after 5 transfusions when SF reaches 500 ng/m and     with either appearance of LPI > 0.2 or TSAT reaches 50% compared with non treatment arm.      So the aim of this study:        1. To determine the time as well as amount of transfused iron ( calculated in mg iron/kg )          which lead to Serum ferritin reaches 500 ng /ml and LPI appearance >0.2 as well as TSAT          reaches 50 % .        2. Tolerability and safety of early low dose DFP 50mg/kg and effectiveness to postpone or          prevent SF from reaching 1000 ng/ml or LPI >0.6 or TSAT >70% in comparison to patients          not starting chelation therapy        3. Determine adverse events whether drug or non drug related   "
84961|NCT02173938|"     Our overall research goal is to determine how these novel psychosocial factors impact     cessation. This pilot study will answer how dual use of other tobacco products, direct to     consumer marketing, and the new phenomenon of butting-out and relighting influences     cessation, and how understanding impulsivity and task persistence could lead to new and     improved behavioral interventions for tobacco dependence. Answers to these pilot questions     will lead to the publication of several manuscripts and provide important feasibility data to     design large, well-powered clinical trials, population-level epidemiological studies, and     contribute to furthering the field of tobacco treatment.   "
84962|NCT02173925|"     The pathophysiology of functional dyspepsia is still unclear but several peptides have been     indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of     appetite and gut motility and serotonin is a typical neurotransmitter related with sensory     and motor functions of gut. On the other hand, transient receptor potential vanilloid     receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal     disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or     glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine     whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric     mucosa of FD patients are different from those in healthy controls, and whether some changes     of their expression correlate with certain dyspeptic symptoms. The investigators also     investigated the effect of H. pylori infection by comparing their expressions before and one     year after H. pylori eradication.   "
84963|NCT02173912|"     This study is designed to evaluate the bioequivalence of the two treatments, the     administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine     besylate, in healthy volunteers.   "
84964|NCT02173899|"     The purpose of this study is to observe the occurrence of adverse events, seroconversion rate     and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.   "
84965|NCT02173886|"     This study is being conducted to evaluate how the body absorbs and processes the sustained     release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are     1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls     will also be enrolled based on a matching criteria to post gastric bypass subjects.     Participants will be asked to complete two 12-hour study days approximately 11 days apart.   "
84966|NCT02173873|"     Aflibercept is FDA approved and the same molecule is available as hyperosmolar for oncology     (cost 800 USD for 4ml) and isoosmolar for Ophthalmology (cost 1,770 USD for 0.05ml     injection). The 4ml bottle can be fractionated to be used in 40 patients hence the 0.05 ml     injection would cost 20 USD for patients. Animal studies showed the injection is safe,     knowing that the rabbit vitreous volume is 3-4 times smaller than the human eye. Our pilot     study is to ascertain if the approved molecule for oncology when injected in the eye is safe     as it is diluted into 5ml vitreous (100 times dilution). If this is so then we can save the     patient 100 times for the most efficient antiVEGF that is used for maculopathy in various     diseases (AMD, DME, CRVO, etc..)   "
84967|NCT02173860|"     The purpose of this study is to determine whether, in patients undergoing elective valvular     heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR     (Fractional flow reserve) would be superior to standard angiography-guided-revascularization     approach on major efficacy and safety outcomes   "
84968|NCT02173847|"     Laser- assisted procedures in penetrating keratoplasty (PK) are proposed to improve the     surgical outcomes: minimally invasive procedures, improved biomechanical stability of the     transplanted flap, reduction of rejection risks, reduction of inflammation, reduction of     infections risk, faster healing process.      In order to achieve these goals, two different lasers were used during PK surgery:        -  a femtosecond laser to cut an anvil shaped profile        -  a diode laser to weld the surgical wound   "
84969|NCT02173834|"     In this study the investigators aim to investigate whether the sympathetic stimulation of     BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed     tomography computed tomography scan, differs between lean and obese individuals, as an     explanation for the diminished metabolic brown adipose tissue activity in obese subjects.      The investigators hypothesis is that sympathetic nervous system activity in the obese is     diminished as compared to their leaner counterparts as an explanation for the diminished     metabolic brown adipose tissue activity in the obese.   "
84970|NCT02173821|"     This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily     dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of     anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No     investigational medicinal product will be administered in connection with this follow-up     study. Eligible patients will attend one visit in this follow-up study.   "
84971|NCT02173808|"     To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a     single 20 mg dose of levonorgestrel butanoate (LB).   "
84972|NCT02173795|"     The primary objective of this study was to investigate patients acceptability / preference of     Berodual® Respimat® inhaler as compared to the conventional Berodual® Metered Aerosol (MA)     inhaler. Ease of handling and assembling the Respimat® inhaler at home under real life     conditions was also evaluated.   "
84973|NCT02173782|"     To demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol     hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium     bromide, 1 puff q.i.d) administered via the Respimat® gives a bronchodilator response which     is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21     µg ipratropium bromide, 2 puffs q.i.d) administered via the MDI and that the safety profile     is at least as good when COPD patients are treated for 12 weeks.   "
84991|NCT02173548|"     -  Heart Failure with Preserved Ejection Fraction (HFpEF) is a common form of heart failure        -  Standard treatment for heart failure, show less than ideal results in HFpEF        -  Evidence of systemic inflammation is common in all forms of heart failure, including          HFpEF        -  The main hypothesis of this study is that systemic inflammation contributes to heart          failure symptoms and exercise limitations in patients with HFpEF        -  The main objective is to treat patients with HFpEF and evidence of systemic inflammation          with an anti-inflammatory drug targeting Interleukin-1 (or placebo) to determine effects          on cardiovascular function   "
84974|NCT02173769|"     The decrease in physical activity due to increasing dyspnoea that over time leads to a     steadily worsening condition and increasing restriction of physical functioning is a key     problem for COPD patients and affects even the early stages.      Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a     marked improvement in physical exercise capacity.      However, there have so far been no data from the daily practice setting about everyday     functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or     Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2     long-acting bronchodilators.      The objective of this NIS is to measure changes in physical functioning as a surrogate for     physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat®     plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine     daily treatment (so-called real life setting).   "
84975|NCT02173756|"     Chemotherapy kills tumor cells but can also damage healthy cells and cause significant     digestive disorders such as ulcers of the mouth, called mucositis. Mucositis are transient     but their intensity may require special measures. Mucositis are painful and morphine gel or     intravenous morphine is used to relieve pain.      However, the pain of oral mucositis induced by chemotherapy is not completely relieved by     morphine administered intravenously.      As part of the study, the investigators want to evaluate an oral gel containing a small     amount of morphine so that it acts directly on the mucositis. The investigators believe that     the direct action of morphine on mucositis may be more effective on pain.   "
84976|NCT02173743|"     Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific     tendinitis which does not respond to conservative treatment. NACD is effective in     approximately 70% of the patients.When NACD is not effective, surgery is often the only     treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for     diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and     the doctors treating those patients will benefit from a more effective minimal invasive     treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering     its positive effect on tissue repair, be a possible solution here.Previous research     investigating the effects of PRP on other tendinopathies did, however, show controversial     results. The aim of this double-blind randomized controlled trial is to investigate the     effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder     function, tendon recovery,resorption of calcific deposits, the percentage of patients with     persistent complaints and quality of life.   "
84977|NCT02173730|"     To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of     BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences.     To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953     ZW.   "
84978|NCT02173717|"     Study to investigate whether and to what extent the suggested P-glycoprotein (P-gp) inducer     rifampicin affects plasma exposure of dabigatran.   "
84979|NCT02173704|"     Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of Novartis     Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly     administered with routine vaccines in healthy infants in Taiwan.   "
84980|NCT02173691|"     The objective of this study is to compare the long-term (six month) bronchodilator efficacy     and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo     inpatients with COPD.   "
84981|NCT02173678|"     Study to assess the safety and tolerability of COMBIVENT® hydrofluoroalkane (HFA) as compared     to COMBIVENT® chlorofluorocarbons (CFC) and placebo HFA after single and repetitive dosing in     healthy male and female subjects   "
84982|NCT02173665|"     The objective of the current study was to investigate safety, tolerability, pharmacokinetics     and pharmacodynamics of BI 1356 BS.   "
84983|NCT02173652|"     The objective was to investigate the influence of 2 different dosage regimens (5 mg once     daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of     orally administered BI 1356.   "
84984|NCT02173639|"     The objective was to assess the relative bioavailability of a pilot scale linagliptin 2.5 mg     / metformin 1000 mg fixed dose combination (FDC) tablet in comparison with single tablets of     linagliptin 2.5 mg and metformin 1000 mg administered together.   "
84987|NCT02173600|"     The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion     activity. It is being implemented by the Andalusian Health Service to reinforce basic     intervention advice on healthy diet and exercise. The IDC intervention is aimed at the     prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and     stroke).      The main objective of the present study is to assess adherence to the IDC intervention and,     consequently, its effectiveness on the prevention of the above mentioned diseases.   "
84988|NCT02173587|"     Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of 100mg/kg     possessed strong anti-inflammatory activity by diminishing the hind paw swelling and     arthritis index in rat model. In the present study, HMLE was processed to capsules under     strict food safety supervision and patients with active rheumatoid arthritis (RA）were     selected to examine whether supplementation with HMLE could improve clinical and laboratory     parameters of disease activity. The validated disease activity score that include 28 joint     counts and ESR (DAS28) and validated clinical disease activity index (CDAI) were primary     outcome measure. Laboratory parameters including IL-1β, IL-6, IL-10, TNF-α,PGE2 and COX-2     were also measured to explore the mechanisms.   "
84989|NCT02173574|"     The purpose of Part 1 is to inform dose selection for use of alisporivir and EDP239 in     combination and obtain initial safety data for co-administration of alisporivir and EDP239 to     support future treatment studies in patients. The purpose of Part 2 is to inform the     drug-drug interaction potential of EDP239 more broadly and possibly facilitate the     interpretation of lower than expected alisporivir concentrations in Part 1, if observed.   "
84990|NCT02173561|"     The purpose of this study is to conduct a randomized controlled trial to compare group and     individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.   "
84992|NCT02173535|"     The study is designed to test five new soft contact lens color pattern variants to determine     whether the test lens makes the wearers eyes look bigger, more defined or enhances their     overall appearance.   "
84994|NCT02173509|"     This is a cluster randomised controlled trial covering all general practitioners working in     the National Health System (SNS) and all pharmacists working in community pharmacies in the     area covered by the Health Region Administration of Center (ARS-C) . A specific educative     intervention, designed from gaps detected in knowledge and attitudes with respect to     antibiotics and resistance, will be carried out on the intervention group. The control group     will not receive any specific intervention.      Hypotheses:        1. The attitudes and knowledge towards antibiotics generate habits of prescription by          physicians        2. The attitudes and knowledge towards to antibiotics generate propensity to dispense          antibiotics without prescription by pharmacists        3. The identification of the attitudes, knowledge and factors that generate habits of          inadequate prescription will allow the design of specific educative interventions to          improve the use of antibiotics        4. The identification of the attitudes, knowledge and factors that generate propensity to          dispense antibiotics without prescription will allow the design of specific educative          interventions to antibiotic use        5. The interventions designed from gaps detected in knowledge and attitudes with respect to          antibiotics and resistance will improve the prescription and dispensation of antibiotics          by physicians and pharmacists, respectively.        6. The intervention will collaborate in the control of the bacterial resistance.   "
84995|NCT02173496|"     Neovascular or wet age-related macular degeneration (ARMD) is a retinal disease and is the     leading cause of sight loss in the over 50s; it constitutes a major public health problem     which will have an increasingly large impact as the population ages, because sight loss has     been associated with loss of independence, depression, social isolation, and falls.      Recent advances in medicine, and in particular the approval on behalf of the National     Institute for Health and Clinical Excellence (NICE) for use of ranibizumab (Lucentis) in wet     ARMD, have allowed this condition to be treated; however success is more likely when     treatments occur at a very early stage.      Unfortunately the early stages of wet ARMD do not cause symptoms and most cases are diagnosed     when irreversible retinal damage has already occurred.      In all stages of ARMD, even when no symptoms are present and non-invasive techniques     currently used in routine clinical practice are not sufficiently sensitive to identify     abnormalities, retinal function and possibly anatomy are abnormal.      This study will evaluate techniques that may be useful in flagging subjects with the     preclinical stages of the disease. This may allow early preventative measures to be taken,     in order to stop altogether the onset of blindness.      The study will focus mainly on colour contrast sensitivity, a simple but highly sensitive     technique to assess retinal function, to establish if people with wet ARMD can be identified     before symptoms develop. Other assessment modalities, evaluating either structure or function     of the retina, will also be employed in selected individuals to establish if they may be used     in the routine clinic; however it is already known that these modalities are not suitable for     all individuals, as they are more demanding time-wise and concentration-wise, and therefore     not universally suitable.   "
84996|NCT02173483|"     The purpose of this study is to determine whether there is a difference in muscle strength     after anterior cruciate ligament comparing 2 surgery technics. Using either autograft     hamstrings tendon or a autograft quadriceps tendon.   "
84997|NCT02173470|"     To assess if information about aortic calcification obtained from routine preoperative ultra     low-dose chest CT lowers the postoperative stroke rate in patients undergoing heart surgery     by optimizing surgical strategy compared to the normal work-up with a conventional chest     X-ray.   "
84998|NCT02173457|"     The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with     Sitagliptin.   "
84999|NCT02173444|"     Serum bio-markers have different prediction values for ovarian response during ovarian     stimulation in-vitro fertilization   "
85073|NCT02172482|"     As part of the post-marketing surveillance, information is to be gathered regarding the     tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of     daily practice   "
85000|NCT02173431|"     Prolonged external pressure to the tissue leads to compression, ischemia and development of     pressure ulcer.      Underweight seems to be associated with high pressure ulcer risk but the distinct relation     between overweight and pressure ulcer development is uncertain.      Bedsores are caused by pressure against the skin that limits blood flow to the skin and     nearby tissue.      Others factors related to limited mobility can make the skin vulnerable to damage and     contribute to the development of pressure sores. Three primary contributing factors are     sustained pressure, friction and shear.      Bedsores are easier to prevent than to treat.   "
85001|NCT02173418|"     The purpose of this study was to test whether peroperative infiltration of the phrenic nerve     during lung surgery would protect patients against postoperative shoulder pain.   "
85002|NCT02173405|"     This research study because is looking at woman with symptoms of chronic pelvic pain caused     by short, tight, and tender pelvic floor muscles (Myofascial Pelvic Pain syndrome). The     purpose of this study is to determine whether or not injections with onabotulinumtoxinA     (Botox) improve symptoms of pain and tenderness. The drug being studied, Botox is FDA     approved for other uses. However, Botox is not FDA approved for the use in myofascial pelvic     pain (MPP). Therefore, Botox is considered experimental or research in this study.   "
85003|NCT02173392|"     A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of     Brodalumab vs. two doses of Brodalumab   "
85004|NCT02173379|"     ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind,     multi-center study, registering approximately 2610 subjects from approximately 140 sites in     the United States and outside the United States. ABSORB IV is a continuation of ABSORB III     (NCT01751906) trial which are maintained under one protocol because both trial designs are     related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV     primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.      The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the     safety and effectiveness as well as the potential short and long-term benefits of Abbott     Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System     (once commercially available), as compared to the commercially approved, control stent     XIENCE.   "
85016|NCT02173223|"     A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and     0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery     and uncontrolled IOP who are facing further surgical intervention. Patients will be treated     for 6 months in this initial trial.      B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the     necessity of further surgical intervention.   "
85032|NCT02173015|"     The purpose of this study is to evaluate the effect that a new fall prevention training     program has on the fall incidence of long-term care facility residents at high-risk of     falling.   "
85005|NCT02173366|"     African American women have among the highest rates of overweight and obesity and few meet     dietary or physical activity guidelines. The investigators seek to develop a new intervention     strategy that will help alleviate health disparities, thereby improving quality of life,     health care costs, and disease burden. The African American Collaborative Obesity Research     Network (AACORN) recommends an eco-social, community-engaged approach to behavior change that     is in line with cultural values of interconnectedness and care for others. The purpose of     this study is to operationalize the AACORN paradigm to promote improvements in weight status     and health through a civic engagement approach. To achieve this, participants will meet in     church-based Change Clubs and be led through a 6 month curriculum, which includes both     lessons in cardiovascular risk reduction and a civic engagement project. Civic engagement may     lead to change in individual health behaviors by increasing self-regulation and     self-efficacy. The investigators will measure club members' adherence to the Change Club     intervention, defined as average number of sessions attended, retention in the clubs,     satisfaction with the Change Club experience and achievement of at least 50% of     self-identified benchmarks for community change within 6 months. In addition the     investigators will compare anthropometric factors, diet and physical activity behaviors,     blood pressure, cardiorespiratory fitness, and psychosocial factors before and after     participation in the Change Club intervention.   "
85006|NCT02173353|"     The purpose of this study is to evaluate the effectiveness of using ultrasound to image and     track pancreas/duodenum motion during radiation therapy treatment delivery. Also develop a     workflow and process to allow the final ultrasound system to be used routinely by radiation     therapists.   "
85007|NCT02173340|"     Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent     bolus of sedative frequently results in inappropriate sedation which comes with various side     effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use     target-controlled infusion(TCI) to provide proper sedation without serious side effects.      In this study, the investigators try to find the appropriate propofol target concentration     with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol     target concentration and side effects.   "
85008|NCT02173327|"     Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery     remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one     approach to minimize the frequency and severeness of PPC.      In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used     routineously after major abdominal surgery.      Recently new devices has been designed, which give the opportunity tip deliver continuously     CPAP with out interruptions because of presumed better comfort. Therefore better patient     compliance.      No studies to date have investigated the possible benefit of using continuously helm CPAP     versus the traditional intermittent mask CPAP after major abdominal surgery.      The investigators' study will investigate if there are any benefits with continuously Helm     CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.   "
85009|NCT02173314|"     The evaluation of the Nevada Initiative to Reduce Long-Term Foster Care (LTFC) includes three     populations. It will examine how the interventions SAFE- FC and FSE impact or relate to     permanency outcomes for children most at risk for long term foster care and currently in     care.   "
85010|NCT02173301|"     The purpose of the study are:        1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of          moderate-to-severe chronic plaque-type psoriasis.        2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis.        3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of          peripheral blood samples.   "
85038|NCT02172937|"     The purpose of this study is to evaluate safety and efficacy using decidual stromal cell     therapy for graft versus host disease after allogeneic hematopoietic stem cell     transplantation. The hypothesis to be tested is that the cells are safe to infuse and that     they have a positive clinical effect.   "
85074|NCT02172469|"     To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg     once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD   "
85011|NCT02173288|"     The development of ascites in the natural history of cirrhosis heralds a worsening of the     prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the     ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to     neurohumoral systems are essential in pathophysiology of ascites formation. The theory that     best explain the ascites formation and sodium retention in cirrhotics is portal hypertension     leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation     which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic     nervous system activation and activation of the anti-natriuretic factors (RAAS and arginine     vasopressin), resulting in sodium and water retention. The therapeutic options available for     patients with refractory ascites are serial therapeutic paracentesis, liver transplantation     and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor antagonists     antagonize the antidiuretic effects of vasopressin at the V2 receptor located in the renal     collecting duct, they increase free water clearance, and thus may be helpful in mobilizing     excess water in conditions associated with water retention including cirrhosis. The use of V2     receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious.     Midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been     used in hepatorenal syndrome (HRS) and for control of ascites in patients with refractory or     recurrent ascites. It is possible that vasoconstrictors and aquaretics (V2 receptor     antagonists) by acting at different sites in combination may reverse some of the pathogenic     events that results in refractory or recurrent ascites.There are no reports on the use of     combination of midodrine and tolvaptan in the patients with cirrhosis with ascites.     Therefore, we plan to study the role of midodrine, tolvaptan and their combination on     systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and     refractory or recurrent ascites.   "
85012|NCT02173275|"     The study seeks to determine the accuracy of using anatomic and physiologic information     measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT     and to compare this measure to stress testing for the detection of myocardial ischemia     against the gold standard of cardiac catheterization with fractional flow reserve. The     hypothesis of this proposal is that integrating anatomic plaque features with physiologic     fractional flow reserve-CT will optimize identification of coronary lesions that are     ischemia-causing by computed tomography .   "
85013|NCT02173262|"     The Integrated Consent Model is being increasingly used internationally to improve patient     care. In this feasibility study we will explore whether the model is feasible in practice;     and whether it can be used to increase the number of physicians and patients who take part in     clinical trials, and address the critical issue around the optimal febrile neutropenia     prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.   "
85014|NCT02173249|"     The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170     0.24% in Healthy, Adult Subjects when used twice daily for one week.   "
85017|NCT02173210|"     This project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone     caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been     associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation.     However, it is not well known why it works for some women but not for others. There are     limited available interventions for the prevention of recurrent PTB. This study will enroll     150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC     and 20% will decline use. We will obtain blood samples and samples of cervical cells and     cervical vaginal fluid. The objective of the study is to identify genetic, microbial and     molecular markers that help to identify which women at risk for recurrent preterm birth will     respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized     screening test based on these markers.   "
85018|NCT02173197|"     To date, there are no studies that demonstrate that the intervention of Occupational Therapy     (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical     and functional outcome for the patient.      For this reason, we intend to undertake a study that will allow us to deepen the knowledge     about the impact of the OT on in-hospital patients considered complex according to the     assessment by the Rehabilitation Complexity Scale (RCS ).      Our hypothesis is that the intervention of OT can improve their care by qualified and focused     on the needs of the person interventions.   "
85019|NCT02173184|"     To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot     treatment period in patients with bacterial vaginosis, based on the Nugent Score and the     Amsel criteria   "
85020|NCT02173171|"     A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who     Previously Received Talimogene Laherparepvec   "
85021|NCT02173158|"     Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous     Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.   "
85022|NCT02173145|"     Idiopathic pulmonary fibrosis (IPF) is a devastating disease with no cure available. Patients     suffer from respiratory symptoms including dyspnea and cough. To improve life quality the     investigators will test the effects of immunomodulation of macrolides specifically on cough     in IPF patients. The investigators hypothesize that immunomodulatory treatment reduces cough     frequency and might improve lung function.   "
85023|NCT02173132|"     This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress,     Work Ability and Work Performance in subjects with Hepatic Encephalopathy.   "
85024|NCT02173119|"     Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for     the treatment of HCC. Palliative means that it does not cure the disease prolongs your life     and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with     an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a     material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected     into an artery (blood vessel) directly supplying blood to a HCC tumor.      Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to     quantify the amount of lipiodol delivered to the HCC tumors.      In this study, the investigators want to see if patient survival is related to the amount of     lipiodol delivered to HCC tumors.   "
85025|NCT02173106|"     This prospective, randomized, controlled, multicenter clinical trial will evaluate     Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of     Idiopathic Membranous Nephropathy.   "
85026|NCT02173093|"     The investigators have found in the previous research that the investigators can coat (arm) T     cells with a special molecule called GD2 bispecific antibody that will help T cells recognize     neuroblastoma and osteosarcoma cells and kill them. This bispecific antibody recognizes GD2,     a protein found on almost all neuroblastoma and osteosarcoma cells. The investigators put the     GD2 bispecific antibody on T cells and give large numbers of these T cells back to patients.     The investigators think that these T cells may have a better chance of killing neuroblastoma     tumor cells when they are armed with GD2 bispecific antibody. This trial studies the side     effects and best dose of activated T cells armed with GD2 bispecific antibody and how well     they work in treating patients with neuroblastoma, osteosarcoma, and other GD2-positive solid     tumors.   "
85027|NCT02173080|"     This Pilot study will enable development & assessment of a Polycystic Liver Disease-specific     patient reported outcomes questionnaire (PLD-Q). Polycystic liver disease (PLD) is     characterized by the formation of numerous cysts in the liver, and can lead to severe     symptomatic hepatomegaly. It is common in patients with autosomal dominant polycystic liver     disease (ADPLD) and autosomal dominant polycystic kidney disease (ADPKD).   "
85028|NCT02173067|"     The purpose of this study is to investigate the variation in blood glucose levels,     hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes     mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and     without epinephrine.   "
85029|NCT02173054|"     Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such     as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another     way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory     property could reduce irritant effects, emergent from using topical treatment and also reduce     severity of acne.      Research teams chose an adapalene gel to act as topical treatment for curing acne. It has     anti-inflammatory and comedolytic effects and has fewer side effects than other groups of     topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching     sensation may occur if they are continually used for a long period. Thus, for the purpose of     studying the efficacy of moisturizer containing licochalcone A, L-carnitine and     1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has     anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has     anti-bacterial effect).   "
85030|NCT02173041|"     Substance Use Disorder has been showing a rising trend all over the world including India.     The project tested whether a Integrated community wide effort of Prevention and Awareness     Groups (PAG) to manage substance use would have a greater effect on treatment attendance and     drug abstinence than a de-addiction program alone.   "
85094|NCT02172209|"     Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a     single dose BI 10773 tablet in healthy subjects   "
85033|NCT02173002|"     Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young     people. The disease is characterized by a heterogenic phenotype and the disease course by     flares and remissions. As in most chronic diseases the economic burden of IBD is important     due to direct health care costs and disability. Health care reorganization for IBD patients     in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal     inflammation results in irreversible bowel damage and complications and none of the presently     available drugs is effective for all patients and many drugs have possible severe side     effects. To prevent complications of the disease and side effects IBD should be monitored     carefully. In the Netherlands however there is a shortage of gastroenterologists where the     incidence of IBD is rising. Secondly evidence exists that direct involvement of health care     workers, patient empowerment and integrated care can improve the outcome of chronic diseases.     Thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not     systematically followed in routine care. Finally the government demands registration of     efficacy endpoints for expensive drugs in the near future. Therefore the investigators     developed a web-based Telemedicine tool for IBD patients in collaboration with the Dutch IBD     patient's organization (CCUVN). myIBcoach contains E-learning modules, monitors disease     activity, disability, quality of life, adherence, infections, smoking status, side effects,     stress and malnutrition on fixed time points with validated questionnaires, allows the     patient to communicate with health care workers and gives feedback to the back office and the     patient. A feasibility study in 30 IBD patients in 3 centres showed a high satisfaction and     compliance of IBD-patients and health care workers with this telemedicine tool.      The aim of this study is to compare standard care for IBD patients in 3 hospitals with a care     via the telemedicine tool myIBDcoach.   "
85034|NCT02172989|"     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer     localization.      In this study, our hypothesis are as following:        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure          better outcome.        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.   "
85035|NCT02172976|"     In this multicenter study, patients with resectable pancreatic carcinoma will be treated with     (a) surgery followed by 6 cycles gemcitabine or (b) 6 cycles FOLFIRINOX followed by surgery     followed by 6 cycles FOLFIRINOX.      The overall survival between both therapies will be compared as well as other parameters.   "
85036|NCT02172963|"     The purpose of this study is to evaluate the safety and efficacy using placenta derived     decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell     transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse     and that they have a positive clinical effect.   "
85037|NCT02172950|"     This multicenter, open-label, phase 3 extension study will investigate the safety and     efficacy of rVIII‑SingleChain for prophylaxis and on‑demand treatment of bleeding episodes in     at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and     previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to     rVIII-SingleChain in this study, as well as in at least 50 previously untreated patients     (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to     rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the     use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to     rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance     induction (ITI) therapy.   "
85041|NCT02172898|"     To conduct a prospective, multicenter, observational study of patients with     well-characterized alcoholic hepatitis (AH) and frequency matched individuals (by age,     gender, and race) with comparable history of alcohol consumption but no clinical evidence of     liver disease (controls). At the end of the study, a robust clinical information, central     bio-repository will be developed from both cases and controls.   "
85042|NCT02172885|"     The purpose of this study is to determine the safety and effectiveness of five infusions of     characterized HLA-identical MSC in non immunosuppressed children with Osteogenesis Imperfecta     (OI).   "
85043|NCT02172872|"     Older patients with acute myeloid leukemia (AML) have a small (< 10%) chance of long-term     survival. Despite the treatment of elderly AML patients with intensive chemotherapy, the     survival has not been improved during the last decades.      The purpose of this study is to determine whether frontline therapy with a 10-day decitabine     schedule provides a better survival than standard intensive combination chemotherapy in     elderly AML patients (>= 60 years).   "
85044|NCT02172859|"     The purpose of this study is to determine whether a chronic dose of a tryptophan-rich protein     drink (lumiVida™) can improve cognitive function, emotional processing and sleep in     middle-aged women. In addition, also genetic predictors of susceptibility to an increase of     Trp levels will be investigated.      lumiVida™ is considered a dietary supplement, and therefore it is not an approved drug by the     Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug     Administration does not strictly regulate herbs and dietary supplements. The investigators do     not claim that this supplement is meant to treat any ailment   "
85045|NCT02172846|"     This phase I trial studies the side effects and best dose of hypofractionated proton beam     radiation therapy when given together with paclitaxel and carboplatin in treating patients     with stage II-III non-small cell lung cancer. Proton beam radiation therapy is a type of     radiation therapy that uses streams of protons (tiny particles with a positive charge) to     kill tumor cells. Giving proton beam radiation therapy at higher doses over fewer days     (hypofractionation) may improve local control of the tumor. Giving hypofractionated proton     beam radiation therapy with chemotherapy may be a better treatment for non-small cell lung     cancer   "
85056|NCT02172703|"     Introduction: Increased intracranial pressure (ICP) is considered to be the most important     intracranial mechanism causing secondary injury in patients admitted after acute traumatic     brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage     (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two     ICP measurement methods available - intraventricular and intraparenchymal - require both a     neurosurgical procedure in order to implant the catheter and probes within the brain. The     invasiveness of current methods for ICP measurement limits the diagnoses reliability of many     neurological conditions in which intracranial hypertension is a treatable adverse event. A     reliable, accurate and precise non-invasive method to measure ICP would be of considerable     clinical value, enabling ICP measurement without the need of a surgical intervention.      Aim:      The aim of this study is to validate a novel non-invasive ICP measurement device by comparing     its measurement with the gold standard invasive ICP-measurement by intracranial probe. The     device used in this study has been been developed in the Telematic Science Laboratory at the     Kaunas University of Technology, Lithuania.      Methods:      The non-invasive ICP measurement method will be assessed prospectively using repeatable     simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on     patients presenting with TBI and SAH. The device method is based on two-depth transcranial     doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and     extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is     compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe     externally applied by the device. Two-depth TCD device is used as an accurate indicator of     the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in     the intracranial and extracranial segments of OA are identical. The device has the same     ultrasound transmission parameters as existing TCD devices and meets all patient safety     criteria.   "
85046|NCT02172833|"     Over the past few decades, a good number of studies with regard to coagulopathy and increased     bleeding tendency which is defined as macro- or microscopic hemorrhage, declination of     hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially caused by the use of     antibiotics through a variety of suggested mechanisms, including myelosuppression,     immune-mediated destruction of thrombocytes and coagulation factors, and suppression of     vitamin K epoxide reductase or vitamin K-dependent γ-glutamate carboxylase which may lead to     inhibition of biosynthesis of coagulation factor II, VII, IX, and X, have been reported or     published. Nevertheless, many of them are case-series studies or case reports with low level     of evidence, and there have been no large-scale retrospective cohort studies regarding     antibiotic-associated coagulopathy being published. Moreover, in addition to exposure to     antibiotics, there are several risk factors, including severity of illness, hepatic or renal     function, nutrition status, comorbidities such as cancer and hematologic disease, surgery or     other invasive procedure, concomitant use of anticoagulants, NSAIDs, and salicylates, and     age, which may exert influence on the function of the coagulation system as well. Therefore,     the study aims to clarify the association between the use of antibiotics and the increase of     bleeding tendency or the development of bleeding event and to identify possible risk factors     of the increase of bleeding tendency or the development of bleeding event in patients     receiving antibiotic treatment through the application of nested case-control design and the     usage of both the National Health Insurance Research Database (NHIRD) and medical records in     National Taiwan University Hospital during the time period from January, 1995 to December,     2013.   "
85047|NCT02172820|"     Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for     patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous     revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to     participate. Medicaid coverage and similar state-supported insurance are robust predictors of     CR non-participation. There is growing recognition of the need to increase CR among patients     with this form of insurance and other economically disadvantaged patients, but there are no     evidence-based interventions available for doing so. In the present study we are examining     the efficacy of using financial incentives for increasing CR participation among Medicaid     patients. Financial incentives have been highly effective in altering other health behaviors     among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study     are randomizing 130 CR-eligible Medicaid enrollees to a treatment condition where they     receive financial incentives contingent on initiation of and continued attendance at CR     sessions or to a usual-care condition where they will not receive these incentives.     Treatment conditions will be compared on attendance at CR and end-of-intervention     improvements in fitness, decision making and health-related quality of life. Cost     effectiveness of the treatment conditions will also be examined by comparing the costs of the     incentive intervention and usual care conditions with their effects on increasing CR     initiation and adherence. Should this intervention be efficacious and cost-effective, it has     the potential to substantially increase CR participation and significantly improve health     outcomes among low-income cardiac patients.   "
85048|NCT02172807|"     Study to investigate the efficacy and safety of Ba679BR powder inhalation during the     continuous once/day administration to the patients with COPD using oxitropium bromide     (Tersigan® aerosol) as the comparator drug.   "
85049|NCT02172794|"     The primary objective of this study is to evaluate the effect of tiotropium on gross muscular     efficiency   "
85050|NCT02172781|"     Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo     After 19 Days of Tiotropium Treatment   "
85075|NCT02172456|"     Primary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled     tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as     well as in patients with mild, moderate and severe COPD      Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung function), safety and     tolerability   "
85076|NCT02172443|"     The objective of this study is to compare the bronchodilator efficacy and safety of     tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.)     in patients with chronic obstructive pulmonary disease (COPD)   "
85051|NCT02172768|"     The primary objective of this trial is as follows:      To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for     developing an invasive fungal disease (patients who are being treated for acute or chronic     graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell     Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid     Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin     given daily.      The secondary objective of this trial is as follows:      To determine whether adequate exposure of micafungin is attained. To determine the safety of     micafungin in this patient population   "
85052|NCT02172755|"     The purpose of this study is to determine the effects of age on the pharmacokinetic profile     of BIA 2-093 and its active metabolites.   "
85053|NCT02172742|"     The purpose of this study is to investigate the effects of multiple-dose administration of     BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.   "
85054|NCT02172729|"     To investigate whether increased dose of local anesthetic (lidocaine) increases duration of     peripheral nerve block (adductor canal block) and to develop a model for assessing duration     of peripheral nerve blockades. The investigators hypothesize that increasing the dose of     lidocaine (by increased concentration) will increase the duration of an adductor canal block.      The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 )     made earlier with different concentrations of lidocaine and a placebo group. For further     information see trial registration at European Union Drug Regulatory Authorities Clinical     Trial System.   "
85055|NCT02172716|"     The primary objective of this study is to assess the short-term immune response of type-2     diabetics with generalized chronic periodontitis (GCP) to nonsurgical periodontal treatment.      The investigators hypothesize that type-2 diabetes exacerbates the disruption of DC     (dendritic cells)-mediated immune homeostasis associated with periodontitis.   "
85145|NCT02171546|"     Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on     the bioavailability of dabigatran etexilate,      Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe     substrate for P-gp   "
85058|NCT02172677|"     Schemas describe mental structures storing recurrent and organized pattern of information.     Schemas may have a strong influence on the process of storing and retrieving new information     into memory. Previous approaches in the cognitive neuroscience of memory have entirely     focused on the individual dimension of preexisting schemas. In the real world though, much of     our experiences and knowledge are collective or shared. Such social-cultural frameworks     stored in collective memory may also reshape and reconfigure the construction of individual     memories. Attempting to ascertain the influence of collective schema on the neural substrates     of individual memories using cutting-edge brain imaging methods represents the challenge that     MULTIBRAIN seeks to tackle. To achieve this goal, we will record brain activity in a group of     24 participants while there are remembering pictures from a tour at the World War II Memorial     of Caen. This study will seek to identify brain areas of the prefrontal cortex encoding the     organization of knowledge in collective memory using multivariate analyses of brain patterns     of activation, and then to understand how such regions might modulate the recruitment of the     hippocampus during episodic memory retrieval using analyses of effective connectivity. The     organization of knowledge in collective memory is measured in parallel through 1) the     analysis of French social memory of World War II using a corpus of 100 000 television and     radio shows from the National Institute of Audiovisual, and 2) an internet task measuring the     organization of individual knowledge in a large group of individuals that will allow to     separate shared from non-shared memories of the World War II. Once collected, these data will     help us to understand how collective schemas may reconfigure the organization of individual     memories.   "
85059|NCT02172664|"     The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA     approved and marketed universal dental adhesive formulation in adult noncarious cervical     lesions using self-etch and selective etch approaches.      The hypothesis is that using a selective enamel etch with this universal adhesive will     enhance the restoration margin performance.   "
85060|NCT02172651|"     This study seeks to learn more about the vitamin D receptor and its relationship to colon     cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the     receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause     cancer cell death. Vitamin D has been used in other research studies and information from     those other research studies suggests that Vitamin D may help in the treatment of colon     cancer.      Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study     drug will be given 14-28 days prior to your surgery. The number of days will depend on when     the surgery is scheduled.   "
85077|NCT02172430|"     The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium)     powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator.     Secondarily, the long-term efficacy of Ba 679 BR is also investigated   "
85061|NCT02172638|"     The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new approach     to the management of patients undergoing major surgery that re-examine traditional practices,     replacing them if necessary with the best evidence based practices, creating a multimodal     perioperative care pathway designed to achieve early recovery. In Colorectal Cancer Surgery ,     as well as in a number of other procedures it has been shown to reduce Hospitalization by     more than 30% without increasing the rate complications or readmissions.      However information on the results of Fast-track protocols when applied to Gynecological     patients is sparse, being especially notorious the lack of data regarding the efficacy of     Fast-track in the management of Advanced Gynecological cancer.      Hypothesis: the application of a Fast-Track protocol in the management of patients with     advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery     of these patients allowing for an early discharge and significant cost reduction, when     compared with de usual management, without increasing the number readmission or surgery     related complications.   "
85062|NCT02172625|"     Nutrition supplementation with antioxidants have been discussed as a way to further enhance     overall well-being of athletes, promote faster recovery, and improve overall performance. The     use of Protandim, a nutritional supplement containing 5 botanicals (Bacopa extract 150 mg;     milk thistle 225mg; ashwagandha 150 mg; green tea 75 mg; turmeric 75 mg) has shown promise in     an earlier study by reducing oxidative stress and increasing the amount of the anti-oxidant     enzymes in the blood.      The purpose of this study was to examine the effect of ~90 day Protandim supplementation on     5-km running performance and on acute and long term oxidative damage as assessed by blood     markers. Secondarily, another purpose of this study examined the effect of Protandim     supplementation on other blood parameters (such as antioxidant enzyme concentrations) and     measures of quality of life. The experiment was double-blind, placebo controlled. The study     addressed two main questions and two secondary questions:      Main Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) improve     5-km running times? Hypothesis: Protandim would improve 5-km running time by 0.5 min (SD     1-min). This is equivalent to an effect size of 0.5. The placebo group will have no change in     performance.      Main Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days) reduce     oxidative damage at rest as assessed by lipid peroxides (TBARS) in runners? Hypothesis: Based     on the data by Nelson et al. (2006), oxidative damaged would be reduced by 40% (effect size =     4.8).      Secondary Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) in     runners reduce the increase in oxidative damage post-race compared to pre-race as assessed by     lipid peroxides (TBARS)? Hypothesis: Based on the data by Kyparos et al. (2009), we expected     a 45% increase in TBARS post-exercise compared to pre-exercise (effect size of 3.6). However,     we expected that those that are on Protandim for 90 days will only have 31% increase in TBARS     post-race (effect size = 2.5) [based on changes in pre-post lipid peroxides from Arent et al.     (2010)].      Secondary Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days)     improve quality of life according to WHOQOL-BREF (Skevington, Lotfy, O'Connell, & Group,     2004)? Hypothesis: There would be a statistical improvement in the quality of life     post-Protandim supplementation which a small effect size improvement of 0.33.   "
85063|NCT02172612|"     This will be an eight-week, prospective, placebo-controlled, randomized trial to evaluate a     patient-centered team (pharmacist-physician) intervention to improve medication     appropriateness and reduce the use of inappropriate anticholinergic medications in elderly     patients enrolled in the Sanders-Brown Alzheimer's Disease Center (ADC) cohort.   "
85064|NCT02172599|"     The purpose of this study is to examine the contribution of sit-stand workstations to total     daily physical activity in a multi-component office-based 12 month intervention.   "
85065|NCT02172586|"     Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100     mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood     pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12     weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).      Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of     treatment and at the end of the study, evaluated by sphygmomanometric blood pressure     measurement and ABPM      Safety:      Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters   "
85210|NCT02170701|"     -  To determine the therapeutic window of BIBR 1048 in order to select doses for further          studies in the development plan.        -  Twice daily regimen will be tested for most dose levels and once daily administration          will also be evaluated when appropriate.   "
85067|NCT02172560|"     The objectives were to collect information on vital status and pulmonary medication use at     the predicted exit date for patients who participated in two one-year trials and withdrew     prematurely. The primary objective was to ascertain the vital status (dead or alive) of these     patients in the time interval between the patients' withdrawal from the trial and their     predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). The     secondary objective was to collect information on classes of pulmonary medication and some     other specified pulmonary interventions used by these prematurely discontinued patients at     the time of their predicted exit date (i.e 48 weeks from the first intake of randomised     treatment + 30 days) or at date of death (if this occurred during the time interval of     interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).   "
85068|NCT02172547|"     Post marketing Surveillance to gain insights into the effects of therapy with Spiriva®     (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking     during treatment and to obtain safety data regarding adverse events.   "
85069|NCT02172534|"     Study to obtain information about the safety and tolerability of tiotropium bromide     administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult     (≥12 y.o.) cystic fibrosis (CF) patients after single and multiple doses as well as to obtain     pharmacokinetic data for tiotropium in CF patients after single and multiple doses   "
85070|NCT02172521|"     -  Primary objective of this observational study was to gain insights into the effects of          therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of          life and physical functioning in patients with chronic obstructive pulmonary disease          (COPD) and demonstrated hyperinflation.        -  Secondary objective was to obtain safety data regarding adverse events.   "
85071|NCT02172508|"     The primary objective of the study is to investigate the effect of the combined therapy 18 μg     tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on     6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to     severe COPD. The secondary objective of the study includes assessments of the effects of the     combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo plus rehabilitation     on dyspnoea, constant work rate exercise endurance, daily activity and lung volumes. The     third objective of the study is to investigate the correlation between the results of the     6-minute walking test (6MWT), the constant work rate exercise test (CWR) and daily activity.   "
85072|NCT02172495|"     Post-marketing surveillance to gather information regarding the tolerance and efficacy of     Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.   "
85082|NCT02172365|"     The investigators will evaluate the outcomes of allogeneic stem cell transplantation which is     the only curative treatment modality in the patients with chronic myeloid leukemia after     failing tyrosine kinase inhibitor therapy. However, any update was not reported on the     transplant outcomes in the patients failed TKI therapy, thus necessitating update of this     data. Also, the European Group for Blood and Marrow Transplantation (EBMT) risk score is     still of value, but insufficient numbers of patients have been transplanted in recent years     and after TKI therapy to allow a robust reanalysis. Our study hypothesis is that allogeneic     SCT treatment modality can rescue CML patients who failed TKI therapy due to resistance or to     intolerance with improved survival and long-term outcomes. Also, another hypothesis will be     examined if the EBMT risk score proposed pre-imatinib era can reproduce similar prognostic     risk stratification of long-term outcomes in the patients treated with TKI.   "
85083|NCT02172352|"     To investigate the dose response following single inhalation of Ba 679 BR inhalation powder     in COPD patients using pulmonary functions as indicators, and to compare data obtained with     overseas study findings   "
85084|NCT02172339|"     Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in     patients with renal impairment in comparison to healthy subjects.   "
85085|NCT02172326|"     Study to evaluate the pharmacokinetics of tiotropium following 14 days of administration     (18µg once per day) in elderly COPD patients.   "
85086|NCT02172313|"     This trial is conducted in Europe. The aim of the trial is to investigate the effect of food     on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in     a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three     different dosing conditions in healthy subjects.   "
85087|NCT02172300|"     Study to investigate whether tiotropium therapy can increase duration of steady-state     exercise by decreasing dynamic and static lung hyperinflation in COPD patients.   "
85088|NCT02172287|"     To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium     inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A     secondary objective of this study was to compare the impact of tiotropium and salmeterol on     humanistic and economic health outcomes, such as quality of life, patient preference and     Health Resource Utilisation in this patient population.   "
85089|NCT02172274|"     Study to determine the pharmacokinetics of BI 10773 and total radioactivity including     excretion mass balance, excretion pathways and metabolism following the oral administration     of [14C] BI 10773   "
85090|NCT02172261|"     The objective was to investigate whether there was a drug-drug interaction between BI 10773     and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773     and glimepiride were determined when both drugs were given in combination compared to     multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given     alone.   "
85091|NCT02172248|"     The objective was to investigate a possible drug-drug interaction between BI 10773 and     metformin when co-administered as multiple oral doses. Therefore, the relative     bioavailabilities of BI 10773 and metformin were determined when both drugs were given in     combination compared with BI 10773 or metformin given alone.   "
85092|NCT02172235|"     The objective was to investigate the effect of different doses of BI 10773 on the     bioavailability of pioglitazone after multiple oral doses of both drugs   "
85093|NCT02172222|"     Study to investigate the relative bioavailability of BI 10773 and of linagliptin after     concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in     comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.   "
85095|NCT02172196|"     The objective was to investigate whether there was a drug-drug interaction between BI 10773     and sitagliptin when co-administered as multiple oral doses. Therefore, the relative     bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in     combination compared with BI 10773 or sitagliptin given alone.   "
85096|NCT02172183|"     This is the first randomized controlled study that tests the efficacy of a     cognitive-behavioral group therapy (CBT) on adolescents with ADHD who were in pharmacological     treatment but still presented persistent symptoms.   "
85097|NCT02172170|"     Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single     rising oral doses of BI 10773 to healthy male subjects.   "
85098|NCT02172157|"     Primary objective:      To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS -     glucuronide and [14C]-radioactivity including excretion mass balance, excretion pathways and     metabolism following intravenous and oral administration of [14C]BI 1744 CL      Secondary objective:      To determine safety and tolerability following intravenous and oral administration of [14C]BI     1744 CL in healthy male subjects   "
85099|NCT02172144|"     Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG     (electrocardiogram) in comparison to placebo   "
85100|NCT02172131|"     To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI     1744 CL   "
85101|NCT02172118|"     Study to assess the influence of severe renal impairment on the pharmacokinetics (PK),     safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by     inhalation with the Respimat® Inhaler)   "
85102|NCT02172105|"     Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy     Japanese male volunteers.   "
85103|NCT02172092|"     The purpose with the study is to follow the fluid shifts that occur during fluid     resuscitation of patients with diabetic ketoacidosis.      In the study measurements of changes in blood and urine concentrations of Sodium and Chloride     as well as blood hemoglobin are used to mathematically calculate changes in distribution     volumes of these different endogenous markers.   "
85132|NCT02171715|"     The primary objective of the study was to investigate the relative bioavailability and     pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet     (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in     comparison with the drinking solution and in comparison with the trial formulation II tablet,     which was administered in phase II clinical trials and also partly in phase I trials.   "
85104|NCT02172079|"     Controversy exists regarding the effectiveness of manual therapy techniques for the     management of impingement syndrome. However, no adequately powered clinical trials have     examined the effects of mobilization-with-movement. The purpose of the current study was to     perform a randomized controlled trial comparing the effects of real MWM to a group receiving     a sham intervention on shoulder pain at different moments and active shoulder range of motion     in an adequately powered sample of patients with shoulder impingement syndrome.   "
85105|NCT02172066|"     In the aftermath of natural disasters, e.g., flood disasters, there is a great need for     humanitarian assistance in the domain of psychological support. This is particularly true in     post-conflict settings because people have suffered severely from multiple traumatic events     and situations during their lives. The Narrative Exposure Therapy (NET) is a short-term,     culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder     (PTSD) symptoms.      The investigators want to provide evidence, that NET is an effective and efficient module to     assist people in the aftermath of natural disasters using the example of the recent flood     disaster in Burundi. In addition the investigators aim to explore, how traumatic incidences     and maltreatment during childhood may influence treatment outcomes.   "
85106|NCT02172053|"     Studies show that exercise resistance in workplace can reduce the symptoms of induced labor,     however, the effectiveness of such programs depends on the characteristics of the training     fatigue. Thus, it is expected that this study the intervention group with training heavy     using progressive resistance exercise protocol will be better in reducing fatigue when     compare with light training group.   "
85107|NCT02172040|"     The purpose of this study is to evaluate the effect of celecoxib on the efficacy and safety     of amlodipine besylate in subjects with hypertension requiring antihypertensive therapy.      This study is being conducted to support a future marketing application for KIT-302, an oral     fixed combination drug product (FCDP) consisting of the antihypertensive drug amlodipine     besylate and the non-steroidal anti-inflammatory drug (NSAID) celecoxib.      KIT-302 is being developed as a convenience reformulation FCDP to facilitate and improve     patient compliance with the once a day administration of its individual components,     amlodipine and celecoxib, when used together for the treatment of hypertension in patients     who also require the use of an NSAID for relief of the signs and symptoms of osteoarthritis.      Although the final KIT-302 formulation will be a single capsule, for this study, two separate     capsules will be utilized: one containing a commercial celecoxib capsule (Celebrex®) or     matched placebo capsule and one containing a commercial amlodipine besylate tablet (Norvasc®)     or matched placebo tablet.      The study hypothesis is that treatment with the amlodipine besylate containing capsule plus     the celecoxib containing capsule will reduce blood pressure (BP) in subjects with     hypertension with an efficacy that is not substantially inferior to the effect of amlodipine     besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the     celecoxib capsule).   "
85119|NCT02171884|"     For this project, 4 groups of 38 infants have been created so as to evaluate the impact of     Assisted-Reproduction Technology (ART) and more particularly the two procedures classically     used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of     culture in appropriate in vitro conditions to allow development of the embryo) in contrast     with shorter culture of only two days.      Participation consists in accepting samples to be taken at the birth of the infant:        1. from the umbilical cord.        2. from the placenta.   "
85146|NCT02171533|"     To investigate whether and to what extent the P-glycoprotein inhibitor (P-gp) verapamil     affects the pharmacokinetic parameters of dabigatran with verapamil given at different     dosages, in different formulations (immediate release (IR) and extended release (ER)), and in     different intervals in relation to the dabigatran dose.   "
85108|NCT02172027|"     Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is     inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of     lung cancer patients is a cytological test and serves as an initial diagnosis. These cells     can then be used to prepare a cell block for staining and further tests.      In some research despite clinical suspicions, the cytological diagnosis is negative, due to     the specimen containing too few cells or damage to the cells whilst the specimen is     processed. A new method of identifying rare cells in a fluid is by immunomagnetic separation.     Using this method, an antigen binds to proteins in the cell wall that are unique to tumor     cells. When the fluid is passed through a magnetic field, separation occurs of the cells with     the magnetic tags from the remainder of the cells. The separated cells can then be stained or     cultured.      The currently approved method of immunomagnetic detection has been approved for clinical use     in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli     Biotech company has developed an advanced technology that allows identification of a larger     number of cells without causing morphological damage to the cells.      The purpose of the current study is to examine the technique of immunomagnetic separation in     pleural effusion of lung cancer patients in comparison to the cytological tests. In the     future it is hoped that a larger number of patient samples will be included and further     characterization of the cells will be possible to be compared to the clinical and cytological     characteristics.   "
85109|NCT02172014|"     Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically     ill children with mechanical ventilation      Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with     midazolam in children with mechanical ventilation.      Design: Double-blind randomized controlled study      Patients: Patients age 2 months through 18 years who are admitted in Seoul National     University Hospital pediatric intensive care unit, and applied with mechanical ventilation.      Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline)     is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the     patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing     pharmacist knows that.      Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent.     The start time of study is when the continuous infusion of midazolam and blind reagent are     begun. Assigned research nurse check Comfort behavior scale of the patient every hour     regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours     after begining. If there is any adverse effect or unexpected event, however, the study can be     early terminated.   "
85110|NCT02172001|"     The primary objective of the study is to evaluate and compare the effect of iron isomaltoside     1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral     iron preparations are ineffective or cannot be used.   "
85111|NCT02171988|"     The purpose of the study is to investigate effect of medical treatment and prognosis of     Postural Orthostatic Tachycardia Syndrome (POTS)   "
85112|NCT02171975|"     Multiple passes and attempts while administering spinal anesthesia are associated with a     greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The     investigators hypothesised that the routine use of pre-procedural ultrasound-guided     paramedian spinals reduces the number of passes required to achieve enter the subarachnoid     space when compared to the conventional landmark-guided midline approach.   "
85115|NCT02171936|"     In the care of the chronic pain in pain's department, pain consultation or Evaluation and     Treatment of the Pain Center (CETD), the patients are often in a situation of physical and     psychic suffering which requires a multidisciplinary follow-up. So, 19 percent of the chronic     painful patients lost their employment, are disintegrated because of their pain, this being     able to provocate a loss of their financial autonomy. A large number of painful patients thus     find themselves in situations of social vulnerability even of precariousness often denied and     difficult to detect by the caring team. Precarity is define as  the lack of one or several     securities, in particular the employment, allowing the people and the families to assume     their professional, family or social obligations, and to enjoy their fundamental rights. To     allow a earlier identification of the populations in deprivation situation, the questionnaire     EPICES (Evaluation of the Precariousness and the Disparities of health for the Centers of     Examination of Health (CES)) was administered to more than 7000 people. The individual score,     indicator of the precariousness and the disparities of health, is calculated after answer to     11 questions and was calculated on about 200 000 French people. Among numerous indicators, it     appears that the consumption of psychotropics or a negative perception of the health are     socioeconomic indicators, mode of life and health which are prevailing according to the     quintiles of the score EPICES.      This national study, on the French CETD aims is: 1 - to study prevalence of the social     vulnerability even of the precariousness thanks to adapted questionnaires of which the     questionnaire EPICES, 2 - to identify predictive social-economic factors which generate and     amplify this circumstance, 3 - to identify the patients for whom a situation of     precariousness and social vulnerability is proved true, justifying the earlier orientation     towards the social worker of the Center so allowing a global care of the patient during the     second visit   "
85116|NCT02171923|"     To examine whether the medial prefrontal cortex displays an increased activity during     self-referential processing among remitted depressed patients compared to healthy controls   "
85117|NCT02171910|"     Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP)     to alleviate discomfort and pain during the procedure. This is usually achieved with use of     opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally     benzodiazepines have been used but nowadays propofol is becoming the drug of choice for     sedation during ERCP.      The problem with propofol sedation is the fact that it may case cardiorespiratory depression     and there is no antidote for this like there is for benzodiazepines. Cardiovascular     depression can usually be easily counteracted with drugs that are used to raise blood     pressure or heart rate during general anesthesia but respiratory depression remains a     problem.      The aim of this study is to try to counteract the respiratory depression caused by propofol     sedation using an old respiratory stimulant doxapram as opposed to placebo using a double     blind randomized protocol.      The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the     respiratory depression caused by propofol sedation.   "
85118|NCT02171897|"     This is a single-centre, comparative, prospective randomised trial. It will include 70     patients over a period of 2 years randomized into two groups of 35 patients: one group of     patients treated with osteosynthesis (plate, nail or screw) and the second group treated with     total hip replacement.      The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1     year.      The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality     of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the     rate of complications and deaths will also be measured. Operating time, blood loss and scar     size will also be evaluated.   "
85120|NCT02171871|"     The study will examine changes in the respiratory system mechanics and in respiratory     physiology after exposure of subjects to passive smoking. It is about healthy non-smoking     volunteers and it will be carried out through the techniques of forced oscillation with     Impulse Oscillometry (IOS) technique methodology and nitrogen washout.      The present study will contribute to the understanding of passive smoking consequences on the     respiratory system of healthy non-smokers. Thanks to the nitrogen washout technique, changes     to closing volume and closing capacity will be examined during measurement in different     positions (sitting, decubitus) together with exposure to passive smoking. With IOS     methodology, changes in respiratory system resistance in four positions (standing, sitting,     right and left lateral decubitus) will be evaluated before and after exposure to a passive     smoking environment. Results of the present study are expected to provide interesting     information on the changes in measured parameters not only in different positions but also     after exposure to smoking.   "
85121|NCT02171858|"     Stroke is one of main causes of death and impairment worldwide. Objective of this study is to     analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended     at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke     extension and clinical features.   "
85122|NCT02171845|"     This is a single-centre study over 36 months for the inclusion of 30 patients. The selection     and inclusion of patients will take place according to the criterion of Medical Termination     of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23     WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue     will also be systematically harvested in parallel (liver and psoas muscle) for control     purposes. The gonads will be subjected to molecular biology analyses destined to quantify the     expression of transposons and their inhibitors.   "
85123|NCT02171832|"     The main objective of this study was to investigate the influence of mild and moderate liver     impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744     CL in comparison to a control group with normal hepatic function after single orally inhaled     administration of BI 1744 CL with the Respimat® Inhaler.   "
85124|NCT02171819|"     This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole     cell vaccine manufactured by the IVAC in Vietnam when given in two injections in two doses     (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam.   "
85125|NCT02171806|"     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL   "
85126|NCT02171793|"     Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral     doses of BI 1744 CL.   "
85127|NCT02171780|"     To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL   "
85133|NCT02171702|"     The primary objective of the study was to identify the maximum tolerated dose and to evaluate     safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992.   "
85134|NCT02171689|"     The aim of the study was to investigate the metabolism and pharmacokinetics of BIBW 2992 MA2     after a single oral dose of [14C]-radiolabelled BIBW 2992 MA2 in healthy male volunteers.     Metabolites in human plasma and excretions were measured, the structures of the metabolites     analysed and compared with metabolites in animals. In addition, the mass-balance of     excretion, the protein binding of [14C]-radioactivity, the plasma concentrations of BIBW 2992     MA2, and the [14C]-radioactivity in blood cells, plasma, urine and faeces were measured. The     safety and tolerability of BIBW 2992 were also investigated.   "
85135|NCT02171676|"     Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and     efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®)   "
85136|NCT02171663|"     The primary objective was the assessment of safety of BIBW 2992 as assessed by the maximum     tolerated dose (MTD). Secondary objectives were collection of overall safety data, antitumor     efficacy data, as well as the determination of pharmacokinetics and the pharmacodynamic     modulation of biomarkers by BIBW 2992.   "
85137|NCT02171650|"     The primary objective was to collect safety data for BIBW 2992.   "
85138|NCT02171637|"     Evaluation of maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBW 2992,     pharmacodynamic modulation of biomarkers, correlation of Epidermal Growth Factor Receptor     (EGFR) and Human EGF-like Receptor number 2 (HER2) immunohistochemical status with objective     tumour responses   "
85139|NCT02171624|"     Open-label, two-way crossover design with a quinidine sulfate run-in period followed by a     randomised sequence of dabigatran etexilate plus quinidine sulfate or dabigatran etexilate     alone to evaluate the safety of co-administration of dabigatran etexilate and quinidine. and     the pharmacokinetic interaction between quinidine and dabigatran etexilate.   "
85140|NCT02171611|"     To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on     food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution,     both with 150 mg of dabigatran etexilate as capsule in healthy volunteers   "
85141|NCT02171598|"     The primary objective of the study (Main Part 2) was to investigate whether and to which     extent a combination of multiple oral doses (steady state conditions) of 75 mg of clopidogrel     q.d. (after a loading dose of 300 mg) and multiple doses of 150 mg of dabigatran etexilate     b.i.d. at steady state affects pharmacokinetic and pharmacodynamic parameters of dabigatran     etexilate and clopidogrel.      The objective of the preceding Pilot Part 1 of the study was to explore the effect of a     single dose of 300 mg clopidogrel administered after multiple doses of 75 mg and 150 mg     dabigatran had reached steady state, regarding safety as well as pharmacokinetic and     pharmacodynamic parameters.      The Main Part 3 of the study moreover was to compare intra-individually the effects of a     single dose of 600 mg clopidogrel with the same dose, 600 mg clopidogrel, given additionally     to multiple doses of 150 mg dabigatran in steady state condition with respect to safety and     pharmacokinetic and pharmacodynamic parameters.   "
85142|NCT02171585|"     To investigate whether and to what extent the reported potent P-gp inhibitor clarithromycin     affects pharmacokinetic parameters (area under the curve (AUC) and maximal concentration     (Cmax)) of dabigatran.   "
85143|NCT02171572|"     The objective of the current study is to investigate safety, tolerability and,     pharmacokinetics of dabigatran etexilate following oral administration of single and multiple     oral doses (110mg, 150 mg b.i.d., 7 days) in healthy Chinese subjects.   "
85147|NCT02171520|"     The objective was to demonstrate the bioequivalence of capsules made from 2 different drug     product batches. The reference batch was representative of the current commercial drug     product and of the pivotal Phase III batches. The test batch was the drug product batch     intended for future commercial use.   "
85148|NCT02171507|"     To investigate the relative bioavailability of dabigatran with and without concomitant     administration of diclofenac and the relative bioavailability of diclofenac with and without     concomitant administration of dabigatran etexilate   "
85149|NCT02171494|"     To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of     Coumadin / formulation tablet   "
85150|NCT02171481|"     To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and     polymorph II   "
85151|NCT02171468|"     To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran     etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days)     in healthy male subjects between Japanese and Caucasians   "
85152|NCT02171455|"     To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters     prior to administration of a high dose of dabigatran etexilate in a QT study   "
85153|NCT02171442|"     The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048 MS     and BIBR 953 ZW in man.   "
85154|NCT02171429|"     This phase III, double blind, placebo and active comparator controlled, multicenter study     will investigate the efficacy and safety of etrolizumab in induction of remission in     participants with moderately to severely active UC who are naïve to TNF inhibitors and     refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.   "
85212|NCT02170675|"     To investigate whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole     affects plasma exposure of dabigatran.   "
86848|NCT02149277|"     The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF     on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection)     protocols as well as in frozen embryo transfer. In addition, following the injection, the     level of G-CSF in the bloodstream will be verified.   "
85155|NCT02171416|"     Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized     by the development of wheal and flare type skin reactions due to the release of histamine and     other proinflammatory mast cell mediators following exposure of the skin to cold. Typically,     symptoms occur within minutes after cold contact, including exposure to cold air, liquids or     objects and are limited to cold exposed skin areas.      The investigators postulate that there is an overlap between acquired cold urticaria and     cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to     antihistamines will benefit from IL-1 targeting treatment strategies.      This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept     in patients with cold contact urticaria who could not be successfully treated with first-line     medication such as antihistamines.      This is a double-blind placebo-controlled parallel group phase II study of the efficacy and     safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the     Urticaria specialty clinics of ACC. The total duration of the study course for each patient     is 14 weeks and is divided in:        1. Screening period (2 weeks, days -14-0)        2. Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42)        3. Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized          (1:1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and          will receive the respective dose subcutaneously. Following the placebo-controlled          double-blind phase patients will enter the open-label phase and receive rilonacept          open-label treatment (160mg or 320mg depending on treatment response during part A).   "
85156|NCT02171403|"     Most people are born with the ability to digest lactose, a dissacharide consisting of     β-D-glucose and β-D-galactose, because of the presence of lactase at the brush border of the     small intestine. In about 75% of the world population the activity of this enzyme decreases     after weaning (primary hypolactasia or lactase-nonpersistence), resulting in incomplete     digestion of lactose and lactose malabsorption in adulthood (1). Secondary forms of lactose     malabsorption may be due to inflammation or functional loss of the intestinal mucosa such as     celiac disease, infectious enteritis or Crohn's disease. Very rarely, lactase deficiency is     congenital due to an autosomal recessive genetic disorder, preventing lactase expression from     birth (2). Whereas some people with lactose malabsorption are asymptomatic, most     lactose-nonpersisters experience symptoms like abdominal pain, bloating, excess flatulence or     diarrhea. Lactose intolerance refers to the syndrome of having one or more symptoms after     consumption of lactose-containing food (3). At present, the origin of the symptoms of     lactose-intolerance is not well understood.      Several studies have indicated a poor correlation between lactose maldigestion and symptoms     of lactose intolerance (4). In a study by Vonk et al. (2003), lactose intolerant subjects     with severe symptoms (diarrhea) and intolerant subjects with only mild symptoms (without     diarrhea) did not differ in degree of lactose digestion in the small intestine indicating a     similar lactase activity and leading them to the hypothesis of a colon resistence factor     (5). It was suggested that the colonic processing of maldigested lactose may play a role in     the symptoms experienced by lactose intolerant patients. When lactose is malabsorbed and     enters the colon, it is rapidly fermented by the resident microbiota into a variety of     metabolites including lactate, formate, succinate and short chain fatty acids (SCFA, acetate,     propionate, butyrate) as well as gases (H2, CO2 and CH4). When incubating fecal samples from     lactose-tolerant and intolerant subjects with lactose, the samples from the     lactose-intolerant subjects showed faster production rates of D- and L-lactate, acetate,     propionate and butyrate, as compared to tolerant subjects (6). Although the colon is thought     to possess a high capacity to absorb SCFA, it was hypothesized that a temporary accumulation     of these metabolites due to rapid fermentation of maldigested lactose could be responsible     for abdominal pain, excess flatulence and bloating (7;8). Possible mechanisms proposed to     explain how SCFA might induce symptoms included an increase in the osmotic load that draws     fluid to the colonic lumen, changes in colonic motility and an increased colonic sensitivity     (9-11). However, the calculated amount of fluid drawn in the colon is unlikely to cause     symptoms considering the high water absorbing capacity of the colon and the effect of SCFA on     colonic motility and colonic sensitivity have only been observed in rats and not in humans.      More recently, Campbell et al. introduced the bacterial metabolic toxin hypothesis, stating     that also other bacterial metabolites, such as alcohols, aldehydes, acids and ketones,     resulting from carbohydrate fermentation play a role in the pathogenesis of     lactose-intolerance. These metabolites might inhibit bacterial growth and affect eukaryotic     cells (12). In our own previous studies in which we related colonic fermentation patterns to     parameters of cytotoxicity, we identified compounds like propionic acid, medium chain fatty     acids, 1-octanol and heptanal as more prevalent in the most cytotoxic samples (13),     supporting the hypothesis of Campbell et al. Therefore, it seems necessary to include not     only SCFA, but also other metabolites, in the investigation of the pathogenesis of lactose     intolerance.      Differences in fermentation patterns might be associated with differences in the composition     and/or activity of the intestinal microbiota. Evidence on the potential role of the colonic     microbiota in lactose intolerance is very limited. Total bacterial numbers were not     significantly different between 16 intolerant and 11 tolerant lactose maldigesters although a     negative correlation between total bacteria and symptom score was found (14). Similarly, the     composition of fecal microbiota was not different between 5 intolerant and 7 tolerant     subjects (6).   "
85157|NCT02171390|"     The study searched for answers to two questions        1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with          congenital hypogonadotropic hypogonadism?        2. What is the effect of testosterone replacement therapy on endothelial dysfunction,          inflammation and insulin resistance?   "
85159|NCT02171364|"     Radiofrequency catheter ablation is highly effective in the treatment of patients with     persistent atrial fibrillation. In order to decrease the recurrence rate after catheter     ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by     simulating 3D atrial computer model. The investigators will test with five different set of     ablation methods and find successful methods for a specific patient. Then, this result will     be compared to empirical catheter ablation result by randomly controlled trial.   "
85160|NCT02171351|"     Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to     increase insulin sensitivity and improve metabolic control. However, adherence to PA is often     poor, due to a lack of motivation or due to disabling complications or comorbidities.     Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve     muscle strength and volume in several situations: after stroke, after limb trauma or during     chest rehabilitation in deconditioned patients. The investigators have already shown in a     first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in the     study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin     sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a     population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up     to 50% in the most deconditioned subjects. Discrepancy between this result and the very low     energy expenditure measured during sessions suggests that the metabolic effect was not solely     mediated by muscle contractions. The investigators hypothesize the involvement of     neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an     important regulator of glucose metabolism with pancreatic action, a key role in energy     metabolism and a complex relationship with insulin resistance. Muscle activity, whether     static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy     subjects but its effect in type 2 diabetic subjects is not known. The investigators     hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity     by NMES could be involved in the improvement of insulin sensitivity. To address this     question, the investigators propose to assess sympathetic nerve activity with the gold     standard method of microneurography before and after a single bi-quadricipital NMES session.     The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular     threshold) and the impact of voluntary isometric muscle contractions (VC) will also be     evaluated. These procedures will also be applied in healthy control subjects.   "
85161|NCT02171338|"     The purpose of this study is to investigate weather or not the use of a     procalcitonin(PCT)-based treatment in the daily clinical work could lower the consumption of     antibiotics in patients with lower respiratory tract infections.   "
85162|NCT02171325|"     The purpose of this study is to identify the appropriate dose of irinotecan by dose     escalation(dose climbing) test. The study would provide rationale for regimen decision in a     future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be     selected as therapeutic drugs.   "
85163|NCT02171312|"     The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain     injury) system is a novel portable, open access platform that enables immediate and rapid     assessment of multimodal neurologic function. This study seeks to evaluate the iDETECT     function testing battery with currently used balance and inner ear assessment methods during     initial concussion clinic referral. Two groups of participants will be enrolled; a concussion     related dizziness cohort and control subjects. The investigators will enroll the concussion     cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent     dizziness and imbalance symptoms following possible concussion. Healthy control participants     will be recruited from the local community. iDETECT's ability to identify post concussion     balance/vestibular disturbances will be compared to an expert concussion assessment. Both     cohorts will participate in the iDETECT assessment and the clinical assessment.   "
86849|NCT02149264|"     This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and     safety of FE 999303 (Testosterone gel) in adult hypogonadal males.   "
85164|NCT02171299|"     Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart     from the obvious immediate action it has been supported that a possible down regulation of     pain receptors may lead to longer effects. Our aim was to compare the use of local     anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.      Materials and methods: We will conduct a RCT involving 400 consecutive general surgery     patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with     ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as     well as the type and quantity of the analgesia used during the study period.      Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic     have lower pain during the 1st postoperative week and require less pain killers .   "
85165|NCT02171286|"     The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a     prospectively defined set of genes.      The purpose of this pilot study is to assess the feasibility and effect on     clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced     lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being     considered for clinical trials.   "
85166|NCT02171273|"     The overall objectives of the proposed study are to examine the consequences of chronic     circadian disruption and chronic sleep restriction on metabolic function in healthy older     adults.   "
85167|NCT02171260|"     This is a Phase 1 study of eribulin mesylate in pediatric patients with recurrent or     refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be     administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims     to determine the MTD and/or the RP2D of this regimen in Part A1 (patients greater than or     equal to 12 months and less than 18 years). Part A2 will enroll infants (greater than 6     months and less than 12 months) one dose level behind the dose level at which patients in     Part A1 are enrolling, in order to maximize safety for infant subjects. Additionally, this     study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when     administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate     will also be described.   "
85168|NCT02171247|"     Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in     the body as an alternative to directly injecting contrast into the vessels and taking     pictures. Different types of intravenous (into the vein, IV) contrast are available to fill     the vessels and make them easier to see. The purpose of the study is to determine the best     type of contrast for this scan.   "
85169|NCT02171234|"     The purpose of this study is to investigate the safety and tolerability of multiple dose     regimens of BIA 2-093 in healthy young male volunteers   "
85170|NCT02171221|"     This is a first-in-human, open label, single arm, sequential dose escalation and expansion     study of oral DFP-11207 in patients with advanced solid tumors.   "
85171|NCT02171208|"     The primary objective of this study is to establish the bioequivalence of the test product     (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012     supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.      The secondary objectives of this study are to determine the safety and tolerability of the     test product compared to the reference product, to estimate PK parameters of the test product     and the reference product, and to estimate the intra-subject coefficient of variation (CV%)     of the referenced product for both area under the plasma concentration curve (AUC) and peak     plasma concentration (Cmax).   "
85172|NCT02171195|"     The purpose of this study is to determine the safety and tolerability of single rising oral     doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg)     in groups of 8 healthy male adult volunteers.   "
85173|NCT02171182|"     The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin     patch in real-life clinical practice in the treatment of post-operative neuropathic pain.   "
85174|NCT02171169|"     The purpose of this retrospective data review is to evaluate the health economic drivers and     complications of two surgical procedures: transsacral lumbar interbody fusion and     transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental     screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and     comply with US regulations and requirements.   "
85175|NCT02171156|"     To provide early access and to evaluate the safety and tolerability of nintedanib in patients     with idiopathic pulmonary fibrosis (IPF).   "
85176|NCT02171143|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of     single, ascending, intravenous (IV) doses of ASP2409 in patients with Rheumatoid Arthritis     (RA) on methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2409.   "
85177|NCT02171130|"     Up to two hundred (200) adult patients with T1D aged 18 to 75 years will be selected for     inclusion in the study. The target is to obtain treatment response and user-experience data     following use of AMG504-1 in treating episodes of hypoglycemia. The population will be     enriched to include participants who suffer from impaired hypoglycemia awareness.   "
85195|NCT02170896|"     To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each     administered as four experimental capsule formulations relative to drinking solution with and     without coadministration of 40 mg pantoprazole.   "
85178|NCT02171117|"     Patients enrolled from each center according to confirmed criteria specified in cooperative     scheme are randomly assigned to standard induction and consolidation chemotherapy with     microtransplantation （MST-group）or without (CT-group).Compare the remission rate and 2-year     disease-free survival (DFS) and overall survival(OS) rate of the two groups.   "
85179|NCT02171104|"     This single-institution, phase II study is designed to test the ability to achieve donor     hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM)     using busulfan- and fludarabine-based conditioning regimens with busulfan therapeutic drug     monitoring (TDM) for patients with various inherited metabolic disorders (IMD) and severe     osteopetrosis (OP).   "
85180|NCT02171091|"     The purpose of this research study is to determine how cell changes during endotracheal     intubation and artificial lung ventilation affect lung inflammation.      Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal     (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic     (lung) samples will be collected at the same time intervals when possible and if they are     done as standard of care.      Blood samples will be obtained simultaneous with the collection of the trachael (windpipe)     specimens.   "
85181|NCT02171078|"     Nearly three million living women have survived breast cancer. Physicians rely on clinical     practice guidelines to make decisions on follow-up care. Among other things, the goal is to     monitor for recurrence or side effects of treatment among survivors. It is unclear whether     these guidelines represent the best approach for any given patient as they do not account for     differences in disease or patient preferences and may not consider recent advances in imaging     and treatment options. We seek to develop a new approach to surveillance following breast     cancer treatment which will be more patient-centered and effective than the existing     one-size-fits-all approach and will consider individual risk factors.   "
85182|NCT02171065|"     The present study has two components, an overall prospective observational study using     multimodality imaging (PROSPECT II) that will examine the natural history of patients with     unstable atherosclerotic coronary artery disease with the specific goal to establish the     utility of low risk intracoronary imaging modalities, Intravascular Ultrasound (IVUS) and     Near InfraRed Spectroscopy(NIRS), to identify plaques prone to future rupture and clinical     events. Due to the difficulty of interpreting the IVUS images, this study will be, however,     using Plaque Burden (PB) ≥65% as the primary threshold defining vulnerable plaques. However,     sensitivity analyses will be run for patients and lesions with PB≥70%. The randomized     PROSPECT ABSORB sub-study will examine whether treatment of vulnerable plaques with the     ABSORB Bioresobable Vascular Scaffold (BVS) plus Guideline Directed Medical Therapy (GDMT)     safely increases the Minimal Lumean Diameter (MLA) at 25 month compared with GDMTalone.   "
85183|NCT02171052|"     To investigate the bioavailability of dabigatran with and without concomitant administration     of digoxin and the bioavailability of digoxin with and without concomitant administration of     dabigatran etexilate   "
85184|NCT02171039|"     To investigate the bioavailability of dabigatran with and without concomitant administration     of atorvastatin and the bioavailability of atorvastatin with and without concomitant     administration of dabigatran etexilate   "
85185|NCT02171026|"     Investigation of the bioavailability, safety and tolerability of dabigatran with and without     concomitant administration of amiodarone and the bioavailability of amiodarone and     desethylamiodarone after administration of a single dose of amiodarone with and without     dabigatran   "
85186|NCT02171013|"     To establish the bioequivalence of two drug product batches of dabigatran etexilate, one     batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate     polymorph II in addition to polymorph I   "
85187|NCT02171000|"     To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral     administration of multiple doses (150 mg b.i.d., 7 days)   "
85188|NCT02170987|"     To investigate if dabigatran has a clinically relevant impact on the cardiac     electrophysiology that is manifest as prolongation in QT-interval.   "
85189|NCT02170974|"     Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg     BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph     I in HPMC capsules   "
85190|NCT02170961|"     this study aim to investigate the:        -  association of RAAS polymorphisms and AHF        -  association of MMP 3 and 12 polymorphisms and AHF   "
85191|NCT02170948|"     Forefoot surgeries involve a relatively short operation usually completed in 1 - 1½ hours,     with patients generally being allowed to go home on the same day. Despite this, post-surgery     pain is often severe and a delay in the discharge of patients due to difficulty with pain     control after the surgery is common.      Performing nerve blocks in association with sedation is the preferred way to provide pain     relief and offers important benefits for foot surgeries. With nerve blocks, the requirement     for oral painkillers and their associated side effects is reduced. Increasing the duration of     local anesthetic action is helpful as it increases the time of pain relief, allowing for a     smoother transition to oral pain medications, earlier discharge, and faster recovery.      Recently, Precedex has been considered for its usefulness in prolonging the pain relief     produced by nerve blocks. The identified benefits of this particular use include reducing     post-surgical pain medications requirements, reducing the incidence of nausea and vomiting,     reducing the incidence of sedation from such medication, and diminishing the incidence of     respiratory depression (inadequate breathing). Two small studies have also shown that adding     dexmedetomidine to nerve block solution results in prolonging pain relief.      The purpose of the study is to examine several doses of dexmedetomidine combined with local     anesthetic drugs and determine the best combination for prolonging pain relief, while     minimizing potential side effects.   "
85192|NCT02170935|"     To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3     hours post surgery in hip replacement patients.   "
85193|NCT02170922|"     Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food   "
85194|NCT02170909|"     Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048     MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg     and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and     Caucasian origin.   "
85196|NCT02170883|"     Between 8% and 12% of Canadians suffer from asthma. Although there are effective and     inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic     diseases.The purpose of this study is to determine whether enhancing the role of community     pharmacists in asthma management using interactive short messaging service (SMS) with asthma     patients is a cost-effective model that will improve adherence to inhaled corticosteroid     medications compared to usual care.   "
85197|NCT02170870|"     To understand why patients with indigestion with or without diabetes have gastrointestinal     symptoms and in particular to understand where the symptoms are related to increased     sensitivity to nutrients.   "
85327|NCT02169180|"     The purpose of this study is to evaluate overall response rate (ORR) (complete response [CR]     rate plus partial response [PR] rate) of ibrutinib (IMBRUVICA™; PCI-32765; JNJ-54179060), as     assessed by an Independent Review Committee (IRC), in participants with relapsed or     refractory mantle cell lymphoma (MCL-a cancer of the lymph nodes or tissues).   "
85198|NCT02170857|"     The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment     of periodontal pockets in people with gum disease.      This research consists of clinical and radiographic studies. Participants should have     symmetric periodontal pockets in the upper or lower jaw.      Participants will be treated surgically using hyaluronic acid on one side of the jaw.      Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken     for each participant before surgical treatment and 12 months after surgical treatment.   "
85199|NCT02170844|"     To investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS     following oral administration of single rising doses from 50 mg to 350 mg in healthy male     subjects of Japanese and Caucasian origin. This was the first administration of this     substance to subjects of Japanese origin.   "
85200|NCT02170831|"     To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.   "
85201|NCT02170818|"     Importance Team members speaking-up by raising concerns about inappropriate or unsafe actions     of others within the team can have direct, immediate, and preventive effect on adverse     outcomes. However, little is known about the hurdles and enablers of this behavior in     healthcare, especially within the operating room setting.      Objective      1. Determine if an educational workshop would improve speaking-up behaviors of practicing     anesthesiologists when presented with realistically-simulated clinical situations. 2.Describe     speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3. Identify the     self-reported hurdles and enablers for speaking-up in those situations encountered.      Design Randomized controlled experiment of an educational workshop intervention on     communication behaviors in a simulated case. Qualitative analysis of debriefing conversations     following the simulated case.      Setting Established academic simulation center      Participants Seventy-one practicing anesthesiologists from four academic medical centers and     one community hospital      Intervention Fifty minute educational workshop on speaking-up that included rationale,     conversational techniques, a rubric for speaking-up, and role-play.   "
85202|NCT02170805|"     The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule     formulation using melt extrusion technology was assessed in two separate, single dose, 3-way     crossover, open design, randomised studies. The 3-way crossover treatments included     administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or     B and administration of the capsules with coadministration of pantoprazole.   "
85203|NCT02170792|"     To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without     coadministration of 150 mg ranitidine.   "
85204|NCT02170779|"     This is a study to determine the impact of education and specific lower extremity stretches     for MS-related spasticity. The study will evaluate the acceptance and efficacy of education     and stretching using a randomized controlled pilot trial.   "
85205|NCT02170766|"     To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and     without coadministration of 40 mg pantoprazole.   "
85206|NCT02170753|"     Purpose: The primary purpose of this study is to determine whether or not the addition of     thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach     consisting of motor control exercises and lumbar spine manual therapy is better than standard     PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain intensity,     disability level, and perceived change in patients with chronic low back pain (CLBP) and     movement coordination impairments.      Hypothesis: In a CLBP subgroup with movement coordination impairments, participants receiving     thoracic, pelvic, and hip manual therapy with standard PT will be superior to participants     receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain intensity,     physical disability level, and perceived change at two, four, and 12 weeks after initiating     treatment.   "
85207|NCT02170740|"     To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters     in healthy volunteer subjects.   "
85208|NCT02170727|"     To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed     dose combination in Genotype 1 Chronic Hepatitis C subjects.   "
85209|NCT02170714|"     Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening     event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a     second line therapy. This study was performed in consecutively observed pediatric patients     with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)-     European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN)     guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical     predictors of poor outcome.      Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative     Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment     through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein,     hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All     patients were treated according to the above mentioned guidelines for ASC and received     intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as     second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy     rate and the efficacy of IFX in avoiding colectomy were evaluated.   "
85211|NCT02170688|"     There are several different methods that can be used to determine the dose of iodinated     contrast material for a CT scan. These include a standard fixed dose, a dose based on total     body weight, a dose based on body mass index, a dose based on lean body weight, and a dose     based on estimated lean body weight. The fixed dose method uses a predetermined amount of     contrast material for all patients having a CT scan of the abdomen regardless of size. This     is the standard procedure currently used at Duke. The other methods use the patient's weight,     either the total body weight or lean body weight, to determine the amount of contrast     necessary for the CT exam. For this study, the investigators will use the fixed dose, total     body weight, the lean body weight, and estimated lean body weight methods. The purpose of     this study is to evaluate these five methods of determining the IV contrast volume and which     may be best for abdominal CT scanning.   "
85213|NCT02170662|"     The purpose of this study is to determine the effect of bimatoprost solution on scalp hair     growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment     of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is     not approved for the treatment of scalp hair loss and its use in this study is considered     investigational which means it is still being tested in research studies.      Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.   "
85214|NCT02170649|"     The purpose of this study is to investigate the effect of food on the pharmacokinetics of a     single 800 mg oral dose of BIA 2-093 in healthy volunteers.   "
85215|NCT02170636|"     Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048     bid over three days each administered as four experimental formulations relative to drinking     solution with and without coadministration of 40 mg Pantoprazole   "
85216|NCT02170623|"     Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after     administration of 50 mg of BIBR 1048 bid over three days each administered as two     experimental formulations relative to drinking solution with and without coadministration of     40 mg Pantoprazole.   "
85217|NCT02170610|"     To assess the extent of absorption of 150 mg of BIBR 1048 administered as capsule formulation     with and without coadministration of 40 mg Pantoprazole and to assess the effect of food on     rate and extent of absorption.   "
85218|NCT02170597|"     Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a     150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after     administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative     bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without     food.   "
85219|NCT02170584|"     Two substudies to assess (1) the tolerability of BIBR 953 ZW intravenous infusion at 0.1, 1     and 5 mg BIBR 953 ZW and (2) the absolute bioavailability of 100mg BIBR 1048 administered as     'acid free' tablet formulation (TF1) and (3) the bioavailability of the 100 mg tablet of BIBR     1048 relative to the tartaric acid solution of 100 mg dose strength and (4) the absolute     bioavailability of the 100 mg tartaric acid solution of BIBR 1048 MS.   "
85220|NCT02170571|"     Assessment of the effect of moderate liver impairment (Child-Pugh classification B) on the     pharmacokinetics and pharmacodynamics of dabigatran after oral administration of dabigatran     etexilate. Determination of safety and tolerability of dabigatran upon administration to     hepatically impaired patients and healthy subjects (matched pairs)   "
85221|NCT02170558|"     To determine if the subject metal reduction software helps to better visualize bone     interphase and fusion reliability. Assess whether the appropriate procedural modification     facilitates clearer images when implanted with a trabecular metal spinal implant   "
85222|NCT02170545|"     Displaced, multi-part intracapsular, proximal humerus fractures represent a major challenge     for patients and orthopedic surgeons. Proximal humerus fractures represent the third most     common fracture after hip and distal radius fractures, and more than 20% of these fractures     meet operative indications. Unfortunately, one of the major complications of these fractures     is the development of avascular necrosis (AVN), or death of the bone as a result of the loss     of blood supply to it. Currently, the ability to predict AVN is limited. The purpose of this     study is to determine if computed tomography imaging can identify a quantifiable predictor of     AVN following this type of humeral fracture.   "
85223|NCT02170532|"     Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two     new medications that have been approved by the United States Food and Drug Administration     (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma     bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There     are also newer devices to deliver these medications into the lungs: breath actuated     nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered     dose inhalers (MDIs or puffers). The purpose of this study is to deliver these new     medications using several different devices and measuring lung function, heart rate, and     sensations of breathlessness.   "
85224|NCT02170519|"     Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle     (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary     vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this     condition. The evidence supporting INO safety and efficacy under these circumstances is     sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary     hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far     from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as     iloprost may be a favorable alternative therapy.   "
85242|NCT02170285|"     The purpose of this study is to test tDCS (transcranial direct current stimulation), a type     of non-invasive brain stimulation, to determine whether it can improve motor function in     children with perinatal stroke and hemiparesis. Children 6-18 years with imaging-confirmed     perinatal stroke and functional motor impairment will be recruited. Children will be     randomized (1:1) to receive sham or tDCS (20 minutes daily) during daily intensive,     goal-directed motor learning therapy (90 minutes). Motor outcomes will be repeated at     baseline, 1 week, and 2 months.      Aim 1: Establish the ability of tDCS to safely enhance motor learning in children with     perinatal stroke.      Hypothesis 1: tDCS is safe and well tolerated in children.      Hypothesis 2: Contralesional, cathodal tDCS increases motor functional gains measured by AHA     at 2 months in children with perinatal stroke.   "
85225|NCT02170506|"     Swallowing is a complex phenomenon that allows oral feeding while protecting the airway. It     involves many brain areas, including primary motor and sensory areas. Its dysfunction, called     oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. In this     case, it is conventionally translated by a swallow response time delay of the swallowing     reflex.      Pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function     that representation center is bi-hemispheric but asymmetric (Hamdy, 1997). Half of patients     with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain     normal swallowing in a few weeks ( Barer, 1989). Mechanisms that determine the recovery     appear to be related to a reorganization of the motor cortex intact. Patients who retain     disorders are those who have not cortical reorganization.      With this in mind a team used different methods known to modulate brain plasticity, which     electrotherapy with an application endo- pharyngeal sensory threshold. This stimulation     increases the excitability of the cortico- bulbar reflex, which improves swallowing function     in the clinical application.      The hypothesis of this work is that the transcutaneous electrical stimulation applied     submental, noninvasive technique, would also have an impact on cortical plasticity may     explain the improved coordination of swallowing observed in earlier studies (Verin , 2011) (     Gallas , 2010).   "
85412|NCT02168075|"     Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical     field, especially in large size or with brain edema, it is necessary to decrease brain volume     to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been     known to decrease ICP effectively. But there are some debates in regard to appropriate dose     of mannitol.   "
85226|NCT02170493|"     The purpose of this study is to use a novel load monitoring technology to correlate limb     loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first to     collect continuous limb loading data and will provide the first objective insight into how     limb loading directs fracture healing. To meet this purpose, two specific aims have been     developed.      Specific Aim 1: Preclinical validation of a load-monitoring insole      The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load     monitoring: development of load sensor technology that is affordable, accurate and capable of     monitoring for over four weeks. To develop this sensor technology into a load-monitoring     insole, the Hitchcock lab will incorporate consumer type electronics into the design,     including a microprocessor, battery, and data storage media.      Following construction of a functional load-monitoring insole, a pilot human study with     orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify     modes of device failure, improve device interfacing and develop data handling protocols and     software for the clinical arm of the proposed study.      Specific Aim 2: Conduct a prospective, direct observational cohort study.      Thirty (30) open tibial fracture patients will be recruited at two centers: University of     Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a walking     boot instrumented with the load-monitoring insole that will continuously record limb loading     and serve as a step counter. X-rays collected at standard-of-care follow-up visits will be     used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A questionnaire     regarding subjective perception of patient compliance will be collected at the first and last     follow-up visits. Data collected from the insole sensor will be correlated to objective     measures of fracture healing and subjective measures of patient compliance to determine the     effect of patient limb loading on injury outcome. The Hitchcock laboratory will develop     software to process and summarize data from the load monitoring insole and continually     improve human interfacing factors of the load monitoring insole based off of feedback from     the clinical team and study participants.   "
85227|NCT02170480|"     It has been the investigators observation that large diameter traction pins cause more     postoperative knee pain than smaller traction pins. To the investigators knowledge, no study     to date has identified knee pain as a consequence of traction pin placement. Furthermore, no     study has identified whether pin size has an effect on the incidence of postoperative knee     pain. The goal of the present study is to establish whether use of temporary skeletal     traction is associated with subsequent knee pain and to determine whether traction pin size     influences the incidence and/or magnitude of knee pain.      Objective #1:      Determine whether pin size influences the incidence and/or severity of postoperative knee     pain in patients who undergo temporary skeletal traction.      Hypothesis:      Larger traction pins are associated with an increase in both the incidence and severity of     postoperative knee pain.      Objective#2:      Determine whether pin size affects musculoskeletal function in the postoperative period.      Hypothesis:      There is no difference between small and large traction pins in postoperative musculoskeletal     function.   "
85228|NCT02170467|"     In healthy humans, the intestinal mucosa acts as an absorption organ and a defensive barrier     preventing the passage of toxic substances from the intestinal lumen to the blood stream.     Malnutrition and absence of exogenous luminal nutrients in the gastrointestinal tract     profoundly affect small bowel morphology and physiology. Many reports have described     alterations of ion and nutrient transport, mucosal atrophy and modifications in the     intestinal permeability to macromolecules in cases of prolonged intestinal rest, as in severe     starvation. These changes may dampen both the absorptive and the barrier functions of     intestinal mucosa.      The assessment of intestinal permeability, by measuring the urinary excretion of substances     that are not metabolised by human tissues and passively cross the intestinal epithelium, is a     reliable and non invasive method to investigate the anatomo-functional integrity of the     intestinal mucosa. Previous studies have shown an increase of permeability in malnourished     humans . The increase of may also increase the risk for inappropriate passage of food     antigens and other noxious substances across the mucosal barrier. To this regard, the     enhanced susceptibility of malnourished subjects to systemic infections and postoperative     sepsis has long been recognised.      Anorexia nervosa is a psychiatric disorder characterised by abnormal eating behaviours aiming     to decrease body weight. Typically, women with anorexia nervosa restrict food ingestion up to     severe starvation. These behaviours usually lead to malnutrition and a more or less prolonged     absence of luminal nutrients in the gastrointestinal tract. Therefore, alterations in the     integrity and functioning of intestinal mucosa are likely to occur in this condition. There     is no information on intestinal permeability in patients with eating disorders. We     hypothesised that, as it occurs in simple starvation and malnutrition, intestinal     permeability should be increased in fasted undernourished people with anorexia nervosa and     decrease after re feeding. Therefore, in the present study, we explored intestinal     permeability of 23 subjects with anorexia nervosa by means of the lactulose-mannitol test and     urinary sucralose excretion and compare them to 46 controls.      Moreover, auto-antibodies (α-MSH ) have been found in patients with anorexia nervosa. The     origin of these auto-antibodies is still unknown , but some studies suggested a digestive     origin. Moreover, modifications of intestinal flora have been described in patients with     anorexia nervosa. Actually, a study of the intestinal barrier of patients with anorexia     nervosa is necessary. In this study, a comparaison of intestinal permeability and     autoantibodies (α-MSH) rate is proposed before and after re-feeding in patients with anorexia     nervosa.   "
85229|NCT02170454|"     The aim of this study is to test the hypothesis that rTMS on the dominant swallowing     hemisphere is able to modify swallowing coordination.   "
85230|NCT02170441|"     The goal of this study is to evaluate time to diagnosis for three assays (line probe,     pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect     resistance to first and second-line anti-tuberculosis (TB) drugs in Mycobacterium     tuberculosis (Mtb) strains in 7 days or less, allowing for rapid diagnosis of extensively     drug-resistant TB (XDR-TB).   "
85231|NCT02170428|"     The overall objective with the study was to contribute to the scientific basis for dietary     and life strategies, policies and dietary guidelines to infants and young children in Denmark     and with special focus on prevention of obesity and diet related chronic diseases such as     type 2 diabetes, ischemic heart disease and osteoporosis.   "
85243|NCT02170272|"     This pilot clinical trial studies a home-based lymphedema care program in improving     lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program     may help head and neck cancer survivors manage their lymphedema and improve their well-being     and quality of life.   "
85232|NCT02170415|"     Numerous surveys have shown that following breast surgery, longterm pain affects around half     of patients. Given that 1 in 9 women will get breast cancer and that surgery is the     cornerstone of treatment, persistent pain represents a major challenge. In addition to the     suffering chronic pain causes to individual patients, the investigators know that it places a     substantial burden on families and carers, and that patients with pain represent an excessive     demand on healthcare resources.      This research will evaluate the impact of introducing a proactive, integrated care plan for     patients having breast surgery. It will assess the effect of the care plan on reducing the     number of patients with pain at 3 and 12 months after their procedure.      The personalised plan involves numerous evidence based steps linked by a single unifying     description aimed at controlling pain, before, during and after the procedure, in hospital     and at home.      Patients at risk of developing pain will be identified prior to the procedure and randomly     allocated to follow either the personalised care plan or to receive 'usual' care. In the     personalised care plan group, participants will get information about chronic pain, be     screened for pain and offered immediate treatment. During their procedure both the surgeon     and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the     likelihood of experiencing pain.      After their procedure, patients will be again screened for pain and further treatment     instigated. Physiotherapists and other allied health professionals such as psychologists will     also be involved as appropriate. A package of care for pain will then be passed on to the     patients' GP, in the form of a written pain management plan, for ongoing care which will be     linked to the hospital. Patients from both groups will be followed up for a year at regular     intervals.   "
85233|NCT02170402|"     The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the     treatment and prevention of bleeding episodes (BEs)   "
85234|NCT02170389|"     This pilot clinical trial studies vaccine therapy before surgery in treating patients with     kidney cancer that has not spread to nearby lymph nodes or to other parts of the body.     Vaccines made from a person's tumor cells and white blood cells may help the body build an     effective immune response to kill tumor cells when they are infused back into the body.   "
85235|NCT02170376|"     The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50     and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK),     in comparison to placebo and 200 mg entacapone (ENT).   "
85236|NCT02170363|"     The purpose of this clinical investigation is to evaluate the performance and safety of the     HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the     HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries.     The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP     and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with     country-specific requirements, under one clinical study protocol.      This study will evaluate the performance of the HM3 LVAS, side effects and undesirable     conditions within acceptable risks and weigh them against the intended performance of HM3     LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical     Device Directive 90/385/EEC (AIMDD).   "
85237|NCT02170350|"     This pilot clinical trial studies how well brief mindful mediation practice works in     improving quality of life in patients with cancer undergoing radiation therapy. Brief mindful     mediation practice may improve the well-being and quality of life of patients with cancer who     are undergoing radiation therapy by increasing levels of mindfulness and reducing stress,     anxiety/depression, and fatigue.   "
85238|NCT02170337|"     A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects     with chronic rhinosinusitis with nasal polyps   "
85239|NCT02170324|"     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),     play an essential role in regulating whole-body energy homeostasis. Excess expansion of WAT     due to positive energy balance and defects in thermogenic gene expression in BAT are     associated with obesity and various metabolic diseases. Until 2009 the question of whether     adult humans had BAT and whether it could conceivably contribute to whole body energy usage     in a meaningful way was a matter of vigorous debate. The publication of three apppers in the     New England Journal of Medicine that demonstrated adult humans do have BAT, that it can be     activated, and that this activation appears to be defective in obesity reframed the debate,     and revived interest in BAT physiology. Recent studies also reveal the presence of a subset     of cells in WAT that could be induced by environmental or hormonal factors to become     ''brown-like'' cells, and this ''beigeing'' process has been suggested to have strong     antiobesity and antidiabetic benefits.      The extrapancreatic actions of glucagon-like peptide-1 (GLP-1) on endothelial cells and the     liver have been reported. Additionally, effects of GLP-1 on adipose tissue have been     described. Studies performed in isolated adipocytes have demonstrated that GLP-1 has the     ability to induce both lipogenic and lipolytic mechanisms in white adipose tissue (WAT) .     More recent study showed that GLP-1 agonism stimulates brown adipose tissue thermogenesis and     browning through hypothalamic AMP-activated protein kinase (AMPK) in animal. However, there     is no data clearly show that GLP-1 agonism stimulates browning of subcutaneous white adipose     tissue (SWAT) in human obesity.   "
85240|NCT02170311|"     The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated     in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500     mg, 800 mg or 1,000 mg iron).   "
85241|NCT02170298|"     The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural     and behavioral subcomponents of self-control, that is cognitive control and reward     functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder.      The investigators hypothesize that LDX is associated with 1a) decreased task-independent     locus coeruleus (LC) activity; 1b) increased task-related activity in LC and the cognitive     control network; 2) increased LC connectivity with the cognitive control network and 3)     improved task performance and self-control. The investigators will test their hypotheses on     fMRI data with linear contrasts of voxel-wise maps of parameter estimates (in both univariate     and connectivity analyses).      The investigators will also assess change in brain activity with the LDX in the LC and     ventral tegmental areas (VTA) as we hypothesize that they are altered in ADHD and related to     cognitive control and self-control dysfunction in ADHD.      The investigators will use a repeated-measures, between-subject design to compare the effects     of oral once daily LDX in a double-blind placebo-controlled randomized trial (RCT) on neural     (fMRI) and behavioral correlates of cognitive control via a working memory and a reward -     delay discounting task in adolescents and young adults.      A new condition has been added which will use a within-subject comparison, cross-over design     between a single dose of LDX versus a single dose of placebo.   "
85352|NCT02168855|"     The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement     Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent,     smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment     (EMA).   "
85244|NCT02170259|"     Introduction. Tension-type headache is a highly prevalent disorder with a significant     socio-economic impact, affecting psychological aspects. This study aims to assess aspects     pertaining to anxiety, depression, headache frequency and pain intensity.      Subjects and methods. A clinical trial was conducted on 84 participants suffering from     tension-type headache, divided into 4 groups, the mean age being 39.76 years (SD 11.38). The     first group received suboccipital soft tissue treatment (ST); the second group was treated     with articulatory technique (AT); the third group was applied a combination of both     techniques (ST and AT) and a forth group which served as control group. Treatment sessions     were administered during four weeks, with a post-treatment assessment, and follow-up after     one month. The investigators conducted Repeated measures Analysis of Covariance (RM-MANCOVA)     to evaluate the effect of treatment on between and within-subject conditions and their     interaction on reported depression, anxiety, and headache pain frequency and intensity.   "
85245|NCT02170246|"     This research project will study whether the drug telmisartan administered in conjunction     with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The     investigators are studying the effect of this treatment in people who have contracted HIV     infection within the past three weeks, and thus have a form of HIV called acute HIV     infection. The investigators will measure biological markers of immune activation in the     blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs     in affected patients.   "
85246|NCT02170233|"     The study aim is to examine point-of-care ultrasound findings, reliability, and ease of     performance in association with fluid responsiveness for patients with severe sepsis and     septic shock. The investigators propose a prospective observational research study of     patients presenting to one of three Yale New Haven Hospital emergency departments, York     Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for     sepsis, severe sepsis or septic shock during their emergency department visit.   "
85247|NCT02170220|"     The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its     metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of     vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy     participants.   "
85248|NCT02170207|"     The purpose of this survey is to evaluate the safety (that is, frequency of adverse events)     and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of     hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron     Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute     gastric mucosal lesion in daily medical practice.   "
85249|NCT02170194|"     There is no question that combat and domestic attacks can be stressful, and can have effects     that last for months or even years, including reliving some of the events through nightmares     or flashbacks, wanting to avoid anything that is a reminder of combat or domestic attack such     as movies or the nightly news, or being jumpy and concerned about security. When someone has     a lot of these symptoms they might be told they have PTSD, but even when that person doesn't     have the full condition, just having some symptoms can affect their ability to function at     the highest level at home, work, or in social settings, and puts you at greater risk for     developing full PTSD. While someone who went through a significant stressful event might not     need a long course of therapy if they don't have full PTSD, the investigator of this study     thinks that working with them from a distance through their smart phone over time may     decrease their symptoms, help them feel better, and prevent full PTSD. Thus the purpose of     this study is to assess how a brief, relatively simple resiliency enhancement strategy,     provided mostly through smart phones, affects someone with stress-related symptoms.   "
85250|NCT02170181|"     This prospective protocol will enroll patients with pathologically confirmed solid     malignancies who receive stereotactic body radiation therapy (SBRT) for oligometastases, for     consolidation after systemic therapy, prior to systemic therapy for the purposes of     debulking, or in the re-irradiation setting. Increasing use of SBRT off of clinical trials in     patients with malignancies of all histologies is being utilized in these settings. However,     individualized outcomes and characteristics of treatments are not prospectively followed and     not well documented. By instituting a registry of patients receiving SBRT in these settings     it will be possible to determine trends in patterns of care and outcomes for refinement and     justification of this treatment.   "
85251|NCT02170168|"     The overall aim of this project is to deliver better health care services through improved     coordination of cancer care within specialist care (at the local hospital Orkdal Hospital)     and community care (13 municipalities in the Orkdal region, Norway), and between these two     levels in the health care system. The Orkdal model is developed and will be implemented and     evaluated within cancer care. Cancer patients living in one of the 12 municipalities     participating in the formal collaboration Samhandlingsenheten i Orkdalsregionen (SIO), or     the municipality of Oppdal, having metastatic and/or loco-regional disease will be included     in the study. Carers and health care providers will be included as well. Results from this     project will be transferable to other parts of Norway and/or to other countries as well as to     patients with other diagnoses causing complex conditions, such as chronic heart-, lung- and     neurological disease.   "
85252|NCT02170155|"     Understanding the onset and progression of spinal cord disorders is an important aim in     clinical neurology. An early diagnosis with consequent therapy might prevent the progression     of disability. Therefore, we aim to determine structural and dynamic changes in the     microstructure of the spinal cord and CSF, and to explore the relationships between the MRI     parameters, clinical disability, and electrophysiology.   "
85264|NCT02169999|"     The purpose of this study is to determine the impact of web-based personalized decision     support on:        1. Patient awareness of treatment goal options and ability to articulate their goals of          diabetes care.        2. Provider awareness of patients' clinical status (e.g. life expectancy) and treatment          preferences.        3. Individualization of care plans in accordance with geriatric diabetes guidelines.   "
85286|NCT02169713|"     The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the     concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the     safety and tolerability of the combined administration of solifenacin, mirabegron and     tamsulosin HCl.   "
85353|NCT02168842|"     The purpose of the study is to determine whether treatment with isradipine is effective in     slowing the progression of Parkinson disease disability.   "
85253|NCT02170142|"     The major goal of this project is to characterize the structural and functional development     of cortical plate and white matter of the human neonatal brain from the equivalent 30     gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535.     Furthermore, it is related to the blue print project of transcriptome atlas (niH RC2MH089921)     with at least 36 million funding also sponsored by niH.      Revealing detailed anatomy at different equivalent gestational ages of human neonatal brain     not only aids in understanding this highly ordered process, but also provides clues to detect     abnormalities caused by genetic or environmental factors. Cerebral vascular measurements     offer important information on cerebral metabolism. However, either anatomical or functional     studies of human brain development during this period are surprisingly scarce. Diffusion     tensor imaging (DTi), a recently developed technology of magnetic resonance imaging (MRi), is     capable of noninvasively delineating macroscopic anatomical components with high contrast and     revealing structures at the microscopic level. Cerebral vascular quantification including     cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRo2) can also be obtained     through noninvasive MRi, specifically arterial spin labeling (aSL) and T2-relaxation under     spin tagging (TRuST) MRi. in this proposed study, the structure and function of neonatal     brain will be explored using noninvasive MRi technologies. 102 infants will be recruited and     no sedation will be applied during MRi. The resultant database will provide reference     standards for diagnostic radiology of premature newborns and reveal the vascular activities     of these newborn brains. Specifically, three aims will be achieved:        1. To delineate the anatomical development of complex structure in the cerebral wall and          white matter tracts of neonatal brains at different equivalent gestational ages.        2. To quantify the cerebral blood flow and metabolic rate of oxygen of neonatal brain.        3. To correlate the structural and functional measurements with the gene transcriptome          results.   "
85312|NCT02169375|"     Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for     controlling electronic devices using only brain signals. Often, the computer software that     analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals     when the training target location is known. The investigators want the BCIs to be more     universal, and not depend on knowing the target location. Therefore, the investigators will     test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.   "
85254|NCT02170129|"     Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase     bone height in the atrophic posterior maxilla for dental implant placement. In bone     reconstructive surgery, in general, autogenous bone is considered as the gold standard,     primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are     available that can overcome the limitations of autologous bone due to their osteoconductive     properties and biocompatibility. Several studies seem to validate these concepts, but further     comparative trials are needed.      Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine     bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach.      Material and Methods: This study was designed as a randomised, controlled, clinical trial.     Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been     bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses     were randomised according to a parallel group design. Sinuses were grafted according to a     lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss)     and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone     (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel     Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same     surgical procedure a sample of bone was harvested for histomorphometric analysis . All     implants were delayed loaded with screw retained temporary crowns 3 months after implants     insertion and with screw retained definitive crowns 4 months later. Outcome measures were     implant survival, biological and prosthetic complications, radiographic marginal bone-level     changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical     significance was tested at the 0.05 probability level, and all values were presented as mean     and standard deviation.   "
85255|NCT02170116|"     The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953     ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048     MS, in healthy male subjects. This was the first administration of this substance to humans.   "
85256|NCT02170103|"     The investigators propose to test the effectiveness of a technique that uses a modified     commercially available ultrasound system used for cardiac imaging, and a commercially     available ultrasound contrast agent (microbubbles) to break up the blood clots that cause     heart attacks. The ultrasound and microbubbles will be applied as soon as possible to     patients presenting to the emergency department, after an EKG confirms that a heart attack is     ongoing. Patients who provide emergent consent will be randomized to either conventional     therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The     ultrasound will be applied both before and after emergent heart catheterization, in order to     break up the blood clots that are not only in the artery supplying the heart muscle, but also     in the small branches (capillaries) that are fed by this artery. Following the randomized     treatment, patients will be followed for the development of any complications (recurrent     heart attack, heart failure, or need for defibrillator placement) as well as by echo and     cardiac MRI to determine how much heart muscle was salvaged by the treatment. A total of 250     patients will be enrolled and followed at two different sites. Randomization will be     stratified at each study site. The initial site enrolling patients will be University of Sao     Paulo Medical School. Wilson Mathias, MD, will serve as the principal investigator for this     site. The other is VU University Medical Center in Amsterdam, where Otto Kamp, MD, will serve     as the principal investigator.   "
85257|NCT02170090|"     This is a multicentre, prospective, randomized, controlled phase III trial designed to assess     the clinical performance of gemcitabine with cisplatin and observation vs. observation alone     in patients after curative intent resection of cholangiocarcinoma and muscle invasive gall     bladder carcinoma.   "
85258|NCT02170077|"     The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of     epileptic patients with refractory simple or complex partial seizures with or without     secondary generalization.   "
85259|NCT02170064|"     The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate     in children and adolescents with epilepsy.   "
85260|NCT02170051|"     This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive     Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention     better improves symptoms and functioning in people with schizophrenia.   "
85261|NCT02170038|"     The clinical phase I study aims at investigating the conversion of the contraceptive compound     norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore     concentrations of ethinylestradiol will be measured from blood samples after administration     of a single intramuscular dose of norethisterone. In a comparison arm concentrations of     ethinylestradiol will be measured from blood samples after administration of a pill     containing ethinylestradiol itself.   "
85262|NCT02170025|"     Assessment of the safety, tolerability and early signs of efficacy of three times a day     orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on     treatment with Orkambi   "
85263|NCT02170012|"     The purpose of this study in healthy elderly people is to evaluate safety, toleration and     time course of plasma concentration of multiple oral doses of PF-06743649- The     pharmacodynamic activity of PF-06743649 will also be assessed.   "
85265|NCT02169986|"     Forgetting is usually listed as the most important cause of low adherence among patients.     Most studies to date have looked at the adherence of adults or adolescent population. No     studies have been done looking specifically at adherence to topical treatment by     parents/caregivers of young children. Our project will try to replicate the same results     among the parents/caregivers responsible for children ten years and under. The population in     this study will be the parents/caregivers of children 10 and under with atopic dermatitis and     the intervention will be the effect of electronic reminders in adherence rates for the use of     a moisturizer which is recognized as part of the standard of care in the treatment of atopic     dermatitis.   "
85266|NCT02169973|"     The purpose of the study is to measure the uptake, distribution, and clearance of 11C-MK-3168     by Positron Emission Tomography (PET) scan and to model the tissue specific kinetics of     11C-MK-3168 with the appropriate input function in human brain in Part A; to measure blocking     of retention of 11C-MK-3168 at the estimated time to maximum plasma concentration after     dosing (tmax) following each single oral doses of JNJ-42165279 and model the exposure/enzyme     interaction of JNJ-42165279 in Part B; to measure the saturation of enzyme inhibition in the     brain at steady state plasma concentrations of JNJ-42165279 (on Day 8) after 7 once-daily     doses of JNJ-42165279 by conducting PET studies with 11C-MK-3168 at trough plasma     concentrations on Day 2 in Part C.   "
85267|NCT02169960|"     The majority of addiction and mental health problems seen in adults present first in youth.     There is strong evidence that prevention and early identification during childhood can     mitigate some of these risks. Students who screen at risk for the development of mental     illness will be offered online intervention programs with personal guidance from a trained     coach. In addition, lessons revolving around resiliency will be provided to all students.      The objectives of this study are:        -  Decreased rates of depression and suicide (as well as rates of suicide attempts)        -  Decreased use of alcohol, tobacco, and other drugs, with additional downstream benefits          such as reduced rates of fetal alcohol spectrum disorder (FASD) and cancer        -  Decreased school drop-out rates Decreased rates of interactions with the justice system        -  Decreased costs across a range of ministries (health, education, justice, human          services), both for youth as well as their families who have been involved in this          program   "
85268|NCT02169947|"     The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study     in rural, African American adults of faith. The study will see whether a weight loss +     maintenance intervention will cause participants to maintain their weight better than a     weight loss only intervention.   "
85269|NCT02169934|"     The purpose of this study is to determine the routes of excretion for TRV130 and it's     metabolites, and to determine and characterize, structurally, the metabolites present in     plasma, urine, and feces in healthy male subjects.   "
85270|NCT02169921|"     The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for     the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the     popliteal arteries with the Japanese population.   "
85271|NCT02169908|"     The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy     has been previously described in mice and in neuronal cell cultures (Massicot 2013); clinical     manifestations and pathophysiological mechanisms potentially involved have also been     described in humans (Andreas 2007) (Attal 2009).      The investigators team plans to conduct a translational clinicobiological research to explain     the nature of the biochemical and molecular mechanisms of the development of     oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose to     realize a pilot study in patients newly treated with oxaliplatin. This will be conducted in     the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion of     20 patients.      The main objective of this pilot study is to evaluate the occurrence of acute and chronic     neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization     of this pain is based on validated tests (Cruccu 2010).      Moreover, the biochemical changes related to oxidative stress and those related to cellular     lipid composition are characterized in these patients.   "
85272|NCT02169895|"     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)     on the levodopa pharmacokinetics when administered in combination with a single-dose of     immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)   "
85273|NCT02169882|"     Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high     mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key     drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose     may be more effective.      There are several highly relevant, outstanding questions related to the appropriate dose of     rifampicin for TBM, before a multicenter phase 3 trial can be performed. These are:        1. Previous phase 2a randomized clinical trial (done in the same setting as this proposed          study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for          TBM is safe and associated with a survival benefit in adults. Given that i.v. rifampicin          is not readily available, this needs to be confirmed using an equivalent higher oral          dose of rifampicin.        2. Recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v. rifampicin          with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may be needed;          but this has not been examined        3. Based on those previous data, there is a need to explore a longer duration of high-dose          rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in the          investigators previous trial suggest that the optimal duration may be > 14 days.        4. There is a need to explore relevant treatment endpoints besides mortality including          neurological, neuroradiological and inflammatory response.   "
85284|NCT02169739|"     Previous studies in animals and humans has shown that brief periods of reduced blood flow to     one organ or tissue in the body can help protect other tissues from subsequent injury caused     by reduced blood flow such as a stroke. This phenomenon is known as remote ischemic     preconditioning and may help protect brain cells after a stroke. The investigators are     studying a specific stroke type called subcortical stroke that is very common and has a high     rate of recurrent stroke and cognition problems despite intensive prevention measures.   "
85285|NCT02169726|"     Back injuries are the most common reason people seeking for effective treatment. One of the     most common treatments in sports medicine for muscular injuries is therapeutic ultrasound,     which is designed to heat the injured tissue and increase the flow of blood to promote     healing.   "
85274|NCT02169869|"     The study will be a randomized clinical trial. Women with less than 10 prenatal visits and/or     2 or more no show visits who desire an Intrauterine Device (IUD) will be considered for     enrollment. If consented and meet inclusion criteria, they will be randomized after delivery     to receive an IUD immediately postplacental or at their routine postpartum visit.      Women who plan to deliver a live birth singleton via vaginal or cesarean delivery at Oregon     Health and Science University (OHSU) hospital will be considered for inclusion in the study.     Women who desire an IUD for postpartum contraception will be approached for study     participation. The postpartum contraception plan is routinely documented during their     prenatal course. It is also addressed by the obstetrical team upon admission to Labor &     Delivery at OHSU. The obstetrical team will identify subjects who present in labor who meet     the criteria of poor prenatal clinic attendance and express interest in intrauterine     contraception. Immediately after vaginal or cesarean delivery, consented subjects will be     randomized to immediate postplacental IUD placement or IUD placement at their routine     postpartum visit. Women randomized to the immediate postplacental IUD group will receive     their IUD within 60 minutes of placental delivery. Prior to discharge from the hospital women     who received a postplacental IUD will be assisted in scheduling a routine postpartum visit     with their primary provider. Subjects who are randomized for IUD insertion at their     postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with     their usual obstetrical care provider. All subjects in the delayed group will be provided     with contact information for the Women's Health Research Unit (WHRU) at OHSU. If a subject     cannot obtain an IUD at her usual place of care, the device will be placed at no cost through     the WHRU.      At 3 months after delivery, all subjects will be contacted by phone, text, or email to     complete a questionnaire to determine whether they have had a known expulsion, pregnancy, or     elective IUD removal. The questionnaire will include questions regarding ease of placement     and overall satisfaction with the timing of placement. Subjects will be compensated for their     participation in the study after the 3 month contact.   "
85275|NCT02169856|"     In our study the investigators want to evaluate the effects of EFTs (emotional freedom     techniques) for reducing incidence of PONV (Postoperative nausea and vomiting). The effects     of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced then it     will be much valuable adjunct to postoperative management of the patients.      Our hypothesis was Emotional freedom techniques are very useful to reduce the incidence of     postoperative nausea and vomiting after laparoscopic cholecystectomy.   "
85276|NCT02169843|"     Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can     inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction     in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of     emergence agitation of children and adults,especially in elderly patients(>64 years) after     using sevoflurane anesthesia.   "
85277|NCT02169830|"     The investigators' study plans to randomize treatment naive patients with vestibular migraine     to an 8 week trial of an escalating dose of either nortriptyline or topiramate followed by an     8 week crossover to the other drug if patient is willing, if patient wants to stay on first     medication we will just continue to follow. During the first 8 weeks if there is an     intolerance to the first drug they can be switched to the other drug at any point and then     followed on that medication for the remainder of the study. Response to therapy will be     quantified by the Migraine Specific Quality of Life (MSQ) and Dizziness Handicap Inventory     (DHI) administered at multiple time points during the study. Three groups of patients that     will be eligible for the study will include 1)Patients with Neuhauser dVM; 2)Patients with     pVM; and 3) Patients with dizziness that falls outside the Neuhauser criteria (non-Neuhauser     vestibular migraine or nNVM).      The investigators' hypothesis is that even patients with dizziness outside of the Neuhauser     dVM and pVM spectrum will respond to treatment for vestibular migraine, and thus likely have     migraine as a cause of their dizziness. Previous research by our group has suggested that     such patients do in fact respond to migraine therapy1. A second goal of the study is to     evaluate the comparative efficacy of nortriptyline and topiramate in the treatment of these     three subgroups of patients with vestibular migraine.   "
85278|NCT02169817|"     Primary Objective:      To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain     (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in     the duration of acute community-acquired diarrhea in Latin American children.      Secondary Objectives:      To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to     demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting     episodes.      To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of     Enterogermina in norovirus acute gastroenteritis (AGE).   "
85279|NCT02169804|"     • To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly     healthy adult male subjects.   "
85280|NCT02169791|"     In an attempt to reduce relapse risk and improve outcomes following haploidentical     transplantation for patients with high risk hematologic malignancies, the investigators will     implement several strategies to augment the well documented effect of NK cell alloreactivity     seen in HLA-mismatched transplantation. These strategies include (1) choosing potential     haploidentical donors for optimal NK-alloreactivity, (2) utilizing proteasome inhibition     post-transplant with MLN9708 to both sensitize tumor cells to NK cytotoxicity and protect     against graft-versus-host disease (GVHD), and (3) eliminating mycophenolate mofetil from the     post-transplant immunosuppression regimen to improve NK cell reconstitution following     haploidentical peripheral blood stem cell transplantation.   "
85281|NCT02169778|"     Obesity has become a global epidemic with huge public health implications. Although clinical     significant weight loss can be achieved by a combination of diet and behavioral modification,     strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are     activated, which compromise weight loss maintenance and increase the risk of relapse. The aim     of this project is to compare the effects of intermittent versus continuous energy     restriction on the compensatory responses previously described using two low calory diets,     with a similar macronutrient distribution. More specifically, this study will analyze, in the     short-term, if an intermittent energy restricted diet is associated with less appetite and     low reduction in energy expenditure when compared with a continuous energy restricted diet.     This project can bring large practical benefits concerning the design of weight loss programs     to minimize weight relapse.   "
85282|NCT02169765|"     Hepatocellular carcinoma (HCC) is the third leading death cancer in the world. It is     important to explore a safe and effective therapy for early-stage HCC. Previous studies     reported that radiofrequency ablation (RFA) has higher efficacy and is associated with fewer     complications and shorter hospital stays than hepatic resection (HR) for early-stage HCC.     However, meta-analysis and systematic review found that RFA is associated with higher     recurrence rate and lower long-term overall survival.   "
85283|NCT02169752|"     This research study is looking at the use of the drug ambrisentan and if it can improve right     ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial     hypertension. It is also looking at using right ventricle function changes as a marker of     disease severity.   "
85296|NCT02169583|"     This will be the first time GSK1325756 Solution for Infusion formulation that has been     administered to humans. Prior studies have been performed with oral GSK1325756. The primary     objectives of this study are to obtain information on the safety, tolerability, and     pharmacokinetics (PK) of single and twice daily intravenous (IV) administration of GSK1325756     in healthy subjects. In Part A, single, escalating doses will be given in the same cohort of     subjects after a seven day washout. In addition, the study will evaluate the absolute     bioavailability of a single dose of the current oral tablet formulation as compared to the IV     formulation in Part A. In Part B, twice daily (BID) intravenous dose administration will be     given for 5 days (9 total doses) in two separate cohorts of subjects. Data from this study     will provide understanding of the safety, tolerability, and PK of intravenously administered     GSK1325756 twice daily to guide dose selection in future clinical studies in patients with     viral respiratory tract infections   "
85287|NCT02169700|"     Myofascial trigger points (MTrPs) are identified through physical examination as     hypersensitive spots within taut bands of skeletal muscle, painful on compression, triggering     characteristic referred pain and generating motor dysfunction as well as autonomic phenomena.     Different dry needling procedures have been described in the treatment of MTrPs. Needling     therapies which consist in partially inserting and withdrawing the needle from the trigger     point site in order to elicit local twitch responses are associated with higher effectiveness     in releasing MTrPs. Deep dry needling has obtained a grade A recommendation compared to sham,     for immediate reduction of pain in patients with upper-quadrant myofascial pain syndrome.     Nevertheless, trigger point dry needling are frequently associated to a post-needling     soreness. The application of ischemic compression (IC) after trigger point injection in the     upper trapezius muscle has shown higher reduction of pain and disability in myofascial pain     patients, compared with trigger point injection alone. To the authors' knowledge, no previous     studies have evaluated the effectiveness of IC or any manual therapy methods for the     treatment of post-needling soreness. The aims of this study were: (a) to evaluate the     effectiveness of IC on reducing post-needling soreness after dry needling of one latent MTrP     in the upper trapezius muscle, and (b) to investigate the effect dry needling combined with     IC, compared to dry needling alone and dry needling combined with placebo IC will have on     cervical range of motion (c) to determine whether psychological factors are predictive of     postneedling pain and (d) to analyze if the relationships between psychological variables and     postneedling pain varied as a function of postneedling soreness treatment   "
85288|NCT02169687|"     The purpose of this study is to assess the efficacy and safety of High Intensity Focalized     Ultrasound (HIFU) in the treatment for toxic Thyroids nodules   "
85289|NCT02169674|"     This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with     Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B     disease. Adolescents will be invited to have a blood test and those without a minimal level     of protection (antibody titer) will be offered a test vaccination to see if they still have     capacity to recall an immune response. About one month later they will get another blood test     to see if a booster response occurred. A few participants will have lost protection (no     booster response) and will be offered a second HB vaccination to restore protection. Results     of this study could influence the way in which children in British Columbia (BC) are     immunized against HB disease.   "
85290|NCT02169661|"     Consumption of ready meals and other convenience foods are rapidly increasing. However,     their nutritional value is problematical. For example, many are high in fats which are     potentially oxidisable resulting in the formation of toxic end products. Consequently the aim     of this study is to assess whether consumption of ready meals rich in certain fats leads to     a post-prandial increase in lipid oxidation products in plasma and whether this can be     ameliorated by reformulating the meals with natural extracts rich in phytochemicals with     potential antioxidant activity in the stomach   "
85291|NCT02169648|"     The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by     determining the pathogenesis of macular edema, which cause a direct effect on visual     function. In particular, we focus on the correlation between the treatment effectiveness of     ranibizumab and the role of the cytokines involved in the cause of macular edema.   "
85292|NCT02169635|"     High myopia is characterized by prolonged axial length and posterior staphyloma, which result     in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to     anatomical improvements, but an higher axial length and the presence of a sever posterior     staphyloma remains to be the two most important risk factors for poor visual outcomes. For     these reasons, a different surgical approach, including macular buckling, might be considered     in those patients with extremely high degree of myopia, in order to counteract the traction     exerted by the posterior staphyloma. Macular buckling with or without pars plana vitrectomy     had been proved to be an effective way to resolve myopic staphyloma related foveoschisis,     macular hole, and associated retinal detachment. In this study, we sought to investigate the     safety and efficacy of a macular buckling technique using a three-armed silicone capsule to     support the posterior staphyloma in high myopia.   "
85293|NCT02169622|"     Atrial Fibrillation is an abnormal heart rhythm that can occur after coronary heart bypass     graft operations. How often this happens and what other problems occur for a person after     these operations needs to be better understood. This study uses a device called the Reveal     XT, a small device that records heart rhythms to track a patient's heart rhythms after the     bypass surgery. The device is implanted at the time the bypass graft is made. The information     that is gathered for this study will help physicians to provide better treatment and     follow-up of the patients under their care.   "
85294|NCT02169609|"     The purpose of this study is to evaluate safety of the triple COG schema with the monoclonal     antibody Dinutuximab + cytokines (GM-CSF and IL2) and isotretinoin (13-cis-retinoic acid, or     RA) in patients with high-risk neuroblastoma.   "
85306|NCT02169453|"     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)     on the levodopa pharmacokinetics when administered in combination with a single-dose of     controlled-release levodopa/carbidopa 100/25 mg (Sinemet® CR 100/25)   "
85307|NCT02169440|"     The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the     assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.   "
85295|NCT02169596|"     Background      Acute coronary syndrome (ACS) is a term representing all diseases related to reduction in     blood flow to the heart characterised by clot formation over a segment of blood vessel     narrowing. A major constituent of clot are blood cells called platelets and many of the     medications used in ACS target platelet function. Ticagrelor is known to reduce platelet     activity in clot formation by blocking a specific step in the process (P2Y12 receptors). A     recent study has found that the presence of ticagrelor may also reduce clot formation by     significantly enhancing another process involving the molecule nitric oxide (NO). This is of     particular interest if translates into clinical practice, as many patients with heart disease     have abnormal function of their blood vessel lining. This is known to cause a reduction in     available nitric oxide. Does this therefore mean these patients will have a reduced response     to ticagrelor therapy and subsequently be at increased risk of clot formation?      Aims        1. Will ticagrelor increase the anti clot effect of vessel lining produced nitric oxide?        2. Do patients with diabetes or smokers, who have poor function of their vessel lining,          have a reduced response to ticagrelor?      Methods      This is a pilot study in which we propose to look at 64 patients with known disease of their     heart blood vessels, with an equal mix of smokers, diabetics, smoking diabetics and non     smoking non diabetics. We will also recruit ten healthy normal subjects to ensure that our     tests produce the same results as the basic science study mentioned above.      To answer the questions posed we will perform blood tests, primarily looking at platelet     function, and non-invasive blood vessel lining assessment. This will be done before and after     ticagrelor treatment on each participant, enabling statistical comparison.   "
85313|NCT02169362|"     The study will examine the safety of using a concentration of proteins from a patient's own     blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn     wound.   "
85314|NCT02169349|"     The purpose of this study is to develop an ultra sensitive assay of mutation detection on     circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of     Non-Small Cell Lung Cancer (NSCLC).   "
85297|NCT02169570|"     Pakistan ranks fifth amongst high tuberculosis-(TB) burden countries, where TB persists as a     major cause of misery and death. The Diabetes Mellitus-(DM) is also on rise in Pakistan and     people suffering from DM are more prone to catch TB as compared to healthy individuals. This     concurrence of two outbreaks may further increase the frequency of TB in Pakistan. The TB DM     co-occurrence results in various clinical issues as TB in DM patient increases blood glucose,     making DM more difficult to treat, while DM raises the risk of treatment failure, relapse and     death among TB patients. In addition, both DM and TB usually coexist with micronutrients     deficiencies like vitamin D, which has a vital role in immunity, insulin functioning and     respiratory health. It has been suggested that the combined supplementation with vitamin D     and calcium might be beneficial in improving the glucose metabolism but the current knowledge     is very limited. In a resource restrained country with double burden of infectious and     non-infectious diseases, an integrated approach with modification of treatment options may     benefit in management of these outbreaks.      Therefore, this study aims whether vitamin D and calcium supplementation could influence the     recovery in patients with TB of lung and DM.   "
85298|NCT02169557|"     The purpose of this study is to demonstrate the treatment success of fexinidazole, at one     year follow-up visit, in HAT stage 1 and early stage 2 patients.   "
85299|NCT02169544|"     The purpose of this study is to evaluate the risk of infections and malignancies among     Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.   "
85300|NCT02169531|"     Diabetes mellitus type 2 is a long-term metabolic disorder that is primarily characterized by     insulin resistance, relative insulin deficiency and hyperglycemia. Our hypotheses is that     liver would be the primary organ responsible for the metabolic disorder because of some     unknown defects, where sugar would not be efficiently converted to glycogen and fat, leading     to hyperglycemia. The constant hyperglycemia would keep pressure on beta-cells in the     pancreas to eventually exhaust their ability to produce and secret sufficient amount of     insulin, exacerbating the disease. The Immunotherapy would enhance the liver functions and     correct the abnormal sugar metabolism. In addition, the ex vivo activated cells produce and     secret growth factors which would help endothelial cells of blood vessels to reproduce and     grow, resulting in reduced arteriosclerosis.   "
85301|NCT02169518|"     The incidence of coronary heart disease (CHD) is significant in the super-obese and     diabetics.      Inflammation is believed to play an important part in the development of CHD, and the large     collection of abdominal fat in the obese person is a vast source of inflammation. Diabetics     have abnormal glucose and cholesterol metabolism which ultimately compromise their bodies'     circulatory system and nerve function.      Cholesterol plays a vital role in CHD. Low-density lipoprotein (LDL) particles carry     cholesterol and deposit it in blood vessel walls which become damaged as a result. When LDL     particles undergo changes chemically (called oxidation) or as a result of high circulating     blood glucose (called glycation), they become more harmful to the body. High-density     lipoprotein (HDL) particles have a protective function in CHD. Not only do they transport     cholesterol away from the blood vessels to the liver to be broken down, they have properties     against oxidation and inflammation. These properties are related to the activity of an enzyme     on HDL called paraoxonase 1(PON1).      Super-obese patients are increasingly treated by weight-reducing surgery (bariatric surgery).     In this study we examine whether weight loss following bariatric surgery results in reduced     inflammatory state, improved HDL function (higher PON1 activity), better control of blood     glucose and less nerve damage.      We will study PON1 activity, inflammation and glucose control in patients with type 1     diabetes (with and without kidney damage) and type 2 diabetes. We will also study the effects     of rapidly rising blood glucose levels on PON1 and glycated LDL in patients undergoing oral     glucose tolerance test.   "
85302|NCT02169505|"     The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab     vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or     haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab     vedotin can help to prevent the disease from coming back.   "
85303|NCT02169492|"     The main objective of this study is to assess the safety and effectiveness of the ReVive SE     (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when     used according to its Instruction for use (IFU).   "
85304|NCT02169479|"     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)     on the levodopa pharmacokinetics when administered in combination with a single-dose of     immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)   "
85305|NCT02169466|"     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)     on the levodopa pharmacokinetics when administered in combination with a single-dose of     controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).   "
85309|NCT02169414|"     The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in     steady-state conditions on the levodopa pharmacokinetics of a single dose of     immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release     levodopa/benserazide 100/25 mg.   "
85310|NCT02169401|"     08-SMI-2012 is a post market, observational, questionnaire based study to assess the     effectiveness of the commercially available Axium neurostimulator in the management of     intractable, chronic pain.   "
85311|NCT02169388|"     Probiotics modulate the gut microflora and immune status in CRC,which can reduce the side     effects of chemotherapy such as diarrhea,infection,neutropenia etc.   "
85315|NCT02169336|"     The primary objective of this study is to evaluate the analgesic efficacy of two dose levels     of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48     hours (SPID48) in subjects with acute moderate to severe pain following unilateral     bunionectomy.   "
85316|NCT02169323|"     There is growing evidence that non-eosinophilic asthmatics are less sensitive to inhaled     corticosteroids (ICS) than eosinophilic asthmatics.      As non-eosinophilic asthmatic patients are treated by ICS according to international     guidelines for asthma, the investigators would like to investigate whether stepping-down of     ICS in these patients may be safe. Indeed, the investigators can reasonably expect that a     progressive cessation of ICS is possible in some of these patients without any clinical     worsening.   "
85317|NCT02169310|"     Background:      - People with a traumatic brain injury (TBI) can have trouble making the best possible     decisions. Researchers want to learn more about the parts of the brain that control decision     making. They also want to know how these are different between people. This may help predict     how people make decisions after TBI.      Objective:      - To learn more about which parts of the brain are involved in making decisions and how     decisions may be hurt after TBI.      Eligibility:      - Adults age 18 to 60.      Design:        -  Participants will be screened with medical history and physical exam. They will also          take memory, attention, concentration, and thinking tests.        -  Participants will do up to 2 experiments.        -  For Experiment 1, participants may have 3 scans:        -  PET: a chemical is injected through a thin tube into an arm vein. Participants lie on a          bed that slides in and out of the scanner.        -  MRI: a strong magnetic field and radio waves take pictures of the brain. Participants          lie on a table that slides in and out of a metal cylinder. It makes loud knocking          noises. Participants will get earplugs. They might be asked to do a task. A coil will be          placed over the head.        -  MEG: a cone with magnetic field detectors is lowered onto participants head.        -  After the scans, participants will perform a decision-making task.        -  For Experiment 2, participants will perform a decision-making task before and after          receiving transcranial direct current stimulation (tDCS).        -  tDCS: wet electrode sponges are placed over participants scalp and forehead. A current          passes between the electrodes. It stimulating the brain.        -  Participants will return 24-48 hours later to repeat the decision-making task.   "
85318|NCT02169297|"     The purpose of this pilot study was to evaluate effectiveness of a novel regional anesthesia     technique developed at the investigators institution, as part of a quality improvement     initiative, to assist with multilevel thoracic pain control in post-Nuss procedure patients.     The investigators hypothesized that the local anesthetic infusion via bilateral     multiperforated soaker catheters placed at extrathoracic sub-paraspinal muscle location under     ultrasound guidance would significantly improve pain control, as reflected by the decrease in     pain intensity score, reduction in opiate requirement and improvement infunctional     rehabilitation measure scores in patients who underwent the Nuss procedure for pectus     excavatum repair. However, the goal of this pilot study was not to detect a statistically     significant difference in the primary outcomes between control and treatment groups (as the     number of study subjects was chosen out of necessity of what could be completed within a     specified time period), but to estimate the parameters which allows appropriate power and     sample size calculations for a future multi-institutional study.   "
85319|NCT02169284|"     This randomized phase II trial studies how well erlotinib hydrochloride works in treating     patients with bladder cancer undergoing surgery. Erlotinib hydrochloride may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
85321|NCT02169258|"     1. The prevalence of significant and complex obstructive coronary artery disease (CAD) is          high in patients who have low extremity artery disease (LEAD).        2. Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA)          remains poor and CAD is an independent predictor of total mortality after PTA.        3. This prospective randomized controlled trial will evaluate the prognostic effects of          routine versus selective coronary angiography before PTA for LEAD and elucidate the          potential mechanism.   "
85322|NCT02169245|"     The objectives of the research are to assess the effects of increased protein and fiber     intake at breakfast on neural activation in brain regions associated with appetitive drive     and reward-driven eating, measures of subjective appetite, and ingestive behavior in     overweight adults. Additional outcomes of interest include the effects of the breakfast     intervention on blood sugar and cholesterol profiles.   "
85323|NCT02169232|"     Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic     bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an     airway while a patient is awake, has many limitations. The video laryngoscope is a device     that is similar to a conventional laryngoscope but uses a video system to visualize the     larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or     bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be     useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic     bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal     intubations in of obese patients. Patients undergoing laparoscopic gastric bypas     andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or     video assisted laryngoscopy. The investigators primary outcome will be the time required for     successful intubation.   "
85324|NCT02169219|"     The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,     combined with rituximab, is effective in treating ANCA-associated vasculitis.   "
85325|NCT02169206|"     This study on frozen shoulder addressed the null hypothesis that there is no difference in     the motion of scapula against the thoracic wall between affected and non-affected shoulder.   "
85326|NCT02169193|"     Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently     occurs in intubated critically ill patients, and plays a major role in the pathogenesis of     ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would     be useful in diagnosing microaspiration of gastric contents in intubated critically ill     patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of     microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good     diagnosis marker of microaspiration compared to the gold standard.   "
85328|NCT02169167|"     Prevalence of diabetic foot ulcers are reported to be 15% in patients who suffer from     diabetes and ulcerations are present in 84% of all diabetes-related amputations. Peripheral     neuropathy leading to unperceived trauma seems to be the major cause of diabetic foot ulcers     with 45-60% of ulcers to be considered merely neuropathic and 45% of mixed, neuropathic and     ischemic etiology. Ulceration of lower limb is one of the most common complications related     with diabetes and one of the major causes for hospitalization of diabetic patients. The most     significant contributors to diabetic lower limb ulceration are neuropathy, deformity,     uncontrolled elevated plantar pressure, poor glycemic status, peripheral vascular disease,     male gender and duration of diabetes. Treatment of lower limb ulcers imposes an enormous     burden on health care resources worldwide, and at least 33% of all expenses are spent to     treat diabetic ulcers manifested as a complication of diabetes.      Although at least 170 topical wound care products are available, evidence of the superiority     of one over another is tenuous, well-designed randomized, controlled trials are rare, and the     number of case-control or observational studies is limited. In recent years, salve prepared     from Norway spruce (Picea abies) resin has successfully been used in medical context to treat     both acute and chronic wounds and ulcers of various origins. The objective of this     prospective, randomized and controlled clinical trial is to investigate healing rate and     healing time of neuropathic diabetic foot ulcer in patients, who are suffering from infected     fore- or mid-foot ulceration (PEDIS-classification ≥ Grade II; 19) originated from Type I or     II diabetes, and in patients whose diabetic ulcerations are candidates for topical treatment     with resin (Study treatment) or octenidine (Control treatment). In addition, factors     contributing with delayed healing of ulceration, antimicrobial properties, safety and     cost-effectiveness of the resin salve treatment and control treatment will be analyzed.   "
85329|NCT02169154|"     This research study is being conducted to investigate the skin irritancy potential of a new     medication which contains two active ingredients (diclofenac and menthol) together in a gel     formulation and is being developed to treat mild to moderate pain and inflammation, such as     acute sport injuries, sprains and strains.   "
85330|NCT02169141|"     This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and     Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).   "
85331|NCT02169128|"     Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life     threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles.     Approximately 40% of all patients with infections caused by S. Pyogenes develop a     streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of     adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on     soft tissues and high risk of death, the microbes are called flesh-eating bacteria. The     present study is a spin-off of the larger EU funded INFECT study, looking at the experiences     of patient and family to understand the impact on every day life. The present prospective     mixed methods study has the potential to provide important knowledge regarding the occurrence     of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how     the care and treatment can be optimized and organized in a person/patient and family centered     way. The study also aims at validate the SF 36 questionnaire for this group of patients.   "
85332|NCT02169115|"     Urticaria is a very frequent skin condition characterized by transient wheal and flare type     skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients     are thought to suffer from persisting urticaria symptoms, which either occur spontaneously,     i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli     such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia     (also known as dermographic urticaria and symptomatic dermographism) is characterized by     whealing and itching following a minor stroking pressure, rubbing or scratching of the skin.     The majority of patients with urticaria factitia benefits from treatment with nonsedating     antihistamines. Some patients, however, do not achieve adequate symptom control even with     updosing of antihistamines and may suffer from substantial quality of life impairment . Since     even very minor stroking of the skin can lead to the development of wheals and severe     itching, these patients are for example limited in their choice of clothing and are impaired     in their social interaction and partnership.      In all patients with a history of wheals after stroking of the skin, a provocation test     should be performed. This can be done by stroking of the skin lightly with a smooth blunt     object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built     instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the     smooth blunt object should be held perpendicular to the skin and should be used to apply a     light stroking pressure to the skin of the upper back or volar forearm. The reaction is     considered positive in patients who show a weal response and report pruritus at the site of     provocation.      Patients with a positive test reaction should be evaluated for individual pressure     thresholds. For this purpose a provocation device (FricTest) has been developed that allows     for reproducible and standardized threshold testing. Threshold testing enables physicians to     assess disease severity and treatment response more precisely.   "
85333|NCT02169102|"     Anxiety, pain and discomfort are common stressful situations that occur during the dentistry     practice, especially in the urgency endodontic practice. Studies have concluded that low     intensity laser therapy is effective in treating pain. However, most studies have reported     the low intensity laser therapy in chronic pain, few studies have shown its application on     acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain     of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be     surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than     usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always     completely effective. Thus, this present study aims to evaluate whether previous therapy with     low intensity laser could, by its analgesic effect, promote greater comfort especially to     this type of patient. 60 patients with acute pulpits pain will be selected to this study     (randomized and double-blinded) and they will be divided in 4 groups:      Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts     (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) -     Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02;     Group 4 (n=15) - Placebo group - Sham Laser Irradiation.      The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial     pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham     laser irradiation). After that, patients with acute pulp irreversible inflammation will be     submitted to conventional endodontic urgency treatment. Data concerning the need of     complimentary local anesthesia will be also taken into account. Data of different groups and     times will be statistically compared.   "
85348|NCT02168907|"     This phase I trial studies the side effects and best dose of CPI-613     (6,8-bis[benzylthio]octanoic acid) when given together with bendamustine hydrochloride and     rituximab in treating patients with B-cell non-Hodgkin lymphoma that has come back or has not     responded to treatment. Drugs used in chemotherapy, such as 6,8-bis(benzylthio)octanoic acid     and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill     them. Giving 6,8-bis(benzylthio)octanoic acid with bendamustine hydrochloride and rituximab     may kill more cancer cells.   "
85349|NCT02168894|"     The goal of this clinical research study is to learn if one acupuncture treatment approach is     more effective than another in helping to relieve neuropathy in cancer patients.   "
85334|NCT02169089|"     Atherosclerotic disease, or hardening of the arteries, is characterized by the thickening of     the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries.     High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role     in developing clinical symptoms of atherosclerosis disease. The complications of advanced     atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack,     stroke and/or death and blockage of arteries.      This study is being done to assess the effectiveness of Spironolactone therapy to slow down     the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a     large vessel coming out of your heart) compared to placebo (look alike sugar pill). This will     be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of     your aortic wall.      Spironolactone is an FDA approved drug used to treat heart failure and in the management of     hypertension (high blood pressure), but in this study it is used for another unapproved     reason. In this study, we would like to evaluate the effects of Spironolactone in people with     diabetes and atherosclerotic disease.   "
85433|NCT02167789|"     This clinical investigation is a prospective, non-randomized, multi-center, pivotal     trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic     feature Physiological Diagnostic (PhD).   "
86850|NCT02149251|"     Records of women who had Pre-genetic diagnosis (PGD) over the last 3 years will be reviewed     and its outcome will be compared to other records of women who had IVF/ICSI without PGD.   "
85335|NCT02169076|"     Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being     implanted in patients with severe heart failure which have failed medical therapy. In     patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a     major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy     (CRT) aims to restore the synchronized contraction of the heart and has proven to be     beneficial for improving ejection fraction of both right and left ventricle as well as     quality of life in selected heart failure patients. The role of CRT in patients with LVADs is     unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function     in LVAD patients and improve their quality-of-life.      The specific questions that this study aims to answer are:        1. What are the effects of CRT on the function of the non-supported right ventricle in          patients with an implanted LVAD?        2. Can the effects of CRT on cardiac function positively impact quality-of-life and          exercise capacity in LVAD recipients?      In this study patients with a previously implanted CRT device, who later receives an LVAD,     will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients     will be followed for an 8-week period, and then switched over to the opposite CRT status. The     total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic     visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final     visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart     function will be assessed with comprehensive echocardiographic studies during the CRT on     and CRT off periods. Quality-of-life and exercise capacity will be assessed with a     standardized questionnaire and a 6-Minute Walk Test.   "
85336|NCT02169063|"     This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron     emission tomography (PET) as a biomarker of treatment response in patients with prostate     cancer that does not respond to treatment with hormones and has spread to other parts of the     body. Carbon-11 acetate and fluorine F 18 sodium fluoride are radioactive drugs that may be     useful in evaluating prostate cancer activity in response to treatment. Comparing results of     diagnostic procedures such as carbon-11 acetate and fluorine F 18 sodium fluoride PET done     before and after therapy may help doctors predict a patient's response to treatment and help     plan the best treatment.   "
85337|NCT02169050|"     Obesity is associated with low-grade inflammation, insulin resistance and low vitamin D     status. Vitamin D has traditionally been known to involve in calcium homeostasis and prevent     rickets; however, recently it has been recognized to inversely associate with many     non-skeletal diseases and conditions including obesity and type 2 diabetes (T2DM). In vitro     studies have demonstrated that vitamin D possesses anti-inflammatory properties. It remains     unknown if the effect of vitamin D on insulin sensitivity is mediated by suppressing     inflammation in human adipose tissues. The main objective of this study was to assess the     association between vitamin D and insulin sensitivity and inflammation in morbidly obese     pre-menopausal women. Obese women (n=76) were recruited from the University of Illinois at     Chicago (UIC) Nutrition and Wellness Center and the UIC medical center bariatric surgery     clinics. Insulin sensitivity/resistance was assessed by (1) Oral glucose insulin sensitivity     (OGIS) index, derived from dynamic oral glucose tolerance test (OGTT), and (2) Homeostasis     model of insulin resistance (HOMA-IR), calculated from fasting steady-state glucose and     insulin. Also, to better understand the potential mechanism and the role circulating vitamin     D (25OHD) plays in adipose tissue inflammation, we assessed messenger ribonucleic acid (mRNA)     expression of vitamin D receptor (VDR) and various inflammatory genes in visceral (VAT) and     subcutaneous adipose tissues (SAT) of obese women that underwent a restrictive bariatric     procedure. We hypothesized that subjects with higher serum vitamin D levels would be less     inflamed and more insulin sensitive and have increased expression of VDR and pro-inflammatory     markers compared to those with lower serum vitamin D levels.   "
85338|NCT02169037|"     This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal     Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial     fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will     be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal     Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV     isolation).   "
85346|NCT02168933|"     Psoriasis is a common skin disease, which affects 2-3% of the population. Up to two third of     patients with psoriasis develop nail changes. These visible changes can be painful and     disabling and are associated with social stigma. Most topical treatments are only partially     effective. Systemic treatments can have serious side effects. Excimer laser is a form of     targeted ultraviolet light therapy that has been successfully used to treat isolated     psoriatic plaques on difficult to treat areas such as scalp or palms. The purpose of this     study is to investigate efficacy of excimer laser for treatment of fingernail psoriasis.     Sixteen patients with stable fairly symmetric fingernail psoriasis will be enrolled. After     obtaining informed consent, an investigator will evaluate the severity of nail psoriasis in     each hand using an objective score, called Modified Nail Psoriasis Severity Index (mNAPSI).     In a random fashion, one hand will be treated with excimer laser and the other hand will     receive sham treatment. During the treatments, patients will wear protective eyewear that     does not permit them to see which hand receives active treatment and which hand receives sham     treatment. Patients will be treated twice a week for 8 weeks. At weeks 8, 12, and16 the     investigator who is blinded to the treatment assignments will re-evaluate the fingernails     using mNAPSI score. Mean change from baseline mNAPSI score at weeks 8, 12, and 16 in hands     treated with excimer compared to hands treated with sham will be measured. We will also     measure patient's assessment of severity of nail disease and the pain or any adverse events     associated with laser treatments. Given the slow growth rate of fingernails, the final     evaluations will be performed at week 16. In summary, this is the first controlled study to     evaluate efficacy of excimer laser in fingernail psoriasis. If found to be effective, excimer     laser could be used as a safe, locally administered treatment for recalcitrant nail     psoriasis.   "
85339|NCT02169024|"     This study addresses the intractable challenges of adverse birth outcomes, including preterm     delivery and low birthweight, by proposing the development, implementation and evaluation of     a model of group prenatal care that could be scaled nationally. Group prenatal care models     have been demonstrated through rigorous research to provide significantly improved birth     outcomes with implications for maternal-child health and substantial cost savings. However,     group prenatal care is currently available to only a small fraction of the more than four     million women who give birth annually in the US. Through the development, implementation and     evaluation of a new model of group prenatal care, we will create an outcomes-focused model of     group prenatal care that will be scalable nationally with an eye toward improving US birth     outcomes.      The long-term objective of the proposed study is to reduce the risk for adverse perinatal     outcomes during and after pregnancy among women and families receiving prenatal care in     health centers in 3 geographic locations serving vulnerable populations: Hidalgo County     Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate     a new and improved model of group prenatal care, Expect with Me, based on our previous     research on group models of prenatal care, which has already yielded favorable behavioral and     biological results in two randomized controlled trials.      We hypothesize that, relative to women who receive standard individual prenatal care, the     women who receive Expect with Me group prenatal care will be significantly more likely to:        1. have better perinatal outcomes, including better health behaviors during pregnancy          (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm          labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum          indicators (e.g., increased breastfeeding);        2. report greater change in risk-related behaviors and psychosocial characteristics that          could be considered potential mechanisms for the program's effectiveness;        3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year          postpartum;        4. have lower healthcare costs through improved outcomes (e.g., appropriate care          utilization, fewer complications, reduced NICU admissions/length of stays)      Comparisons based on propensity-score matched sample of women receiving standard individual     prenatal care at the same clinical sites.   "
85340|NCT02169011|"     The purpose of this study is to examine the different outcomes of breast reconstruction in     women who are treated for breast cancer with mastectomy and subsequently have delayed breast     reconstruction by one of two different surgical techniques both of which are based on the use     of a tissue flap from the patient's back. These techniques are either a latissimus dorsi flap     (LD-flap) or a thoracodorsal artery perforator flap (TAP-flap)      The main objective of the study is to establish whether one of these techniques may result in     a superior outcome and thus should be recommended as first choice treatment rather than the     other.   "
85341|NCT02168998|"     The purpose of this study is to determine whether the presence of a medical clown in a     pediatric emergency department procedure room would reduce children's anxiety. The     investigators hypothesize that this positive influence will be expressed as lower levels of     the stress hormone (Cortisol) in the blood.   "
85383|NCT02168452|"     This study aimed to evaluate the feasibility of dual sentinel node staining method using     mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive     neoadjuvant chemotherapy.      Over the past few years, several studies have found using methylene blue, isosulfan blue,     indocyanine green or radioisotope alone by detection method had several disadvantages.      In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has     potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive     neoadjuvant chemotherapy.   "
85342|NCT02168985|"     The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to     increase household resilience by strengthening families. TFH draws on improved communication     and conflict resolution skill building and the individual's faith-values as a catalyst for     transformation in attitudes regarding gender roles in care giving and the use of violence in     the home. The study hypothesis is that couples who complete the Faithful House Programme will     demonstrate increased communication skills with their spouses and children, which reduces the     negative impact of family stress triggers and ultimately leads to a reduction of intimate     partner violence witnessed by children as well as physical and emotional violence against     children by parents.      The mixed methods study will include a Randomized Control Trial (RCT) of HIV/AIDS infected or     conflicted couples and a child in each household, focus group discussions (FGD) of men, women     and children and key informant interviews of local experts in family violence and social     protection service network providers.   "
85343|NCT02168972|"     The purpose of this study is to provide clinical data pertaining to the safety and     performance of the Globe® Mapping and Ablation System for treating patients with atrial     fibrillation.   "
85344|NCT02168959|"     The primary purpose of the proposed study is to compare postoperative pain scores and total     opioid consumption between two groups randomized to either receive or not receive a femoral     nerve block for pain control following surgical repair of a tibial plateau fracture. Pain     will be assessed post-operatively using standard numeric pain scores rated on a 0 - 10 scale,     as well as using the University new pain assessment tool - the Clinically Aligned Pain     Assessment (CAPA). This new 5 question pain assessment tool has not yet been validated, but     does address several key questions, including patient comfort, pain control, change in pain     status, daily functioning, and sleep quality. Along with post-operative pain scores, we will     compare total opioid consumption between the two groups.      The null hypothesis is that there is no difference in pain scores or total opioid consumption     between patients receiving a femoral nerve block and those without a nerve block following     surgical repair of a tibial plateau fracture.      A secondary outcome will examine long-term pain control, range of motion, and functional     status of these patients at their regular orthopedic clinic follow-up appointments. The same     pain scores will be assessed, along with quadriceps strength and knee range of motion.     Patients will complete the PROMIS Physical Function CAT and short Musculoskeletal Function     Assessment, patient reported outcomes tools to evalute physical function.      A teriary outcome will be to retrospectively examine postoperative pain scores and total     opioid consumption for all tibial plateau fracture patients seen at the University of Utah     for surgical repair in the past 10 years.   "
85345|NCT02168946|"     Carbavance™, (meropenem/vaborbactam) is being compared to the Best Available Therapy in the     treatment of adults with selected serious infections due to Carbapenem Resistant     Enterobacteriaceae   "
85347|NCT02168920|"     To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory [CMAI]     total score from baseline as the primary efficacy variable), dose-response, and safety of     aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation     associated with Alzheimer's type dementia   "
85350|NCT02168881|"     This study is to compare between oral misoprostol in solution and vaginal dinoprostone in     induction of labour in primiparous women with singleton pregnancy as regards efficiency and     safety to both mother and fetus.   "
85351|NCT02168868|"     The purpose of this study is to analyze the immunological profile in blood of children with     ASD.   "
85354|NCT02168829|"     This trial is comparing medical approaches for stroke prevention in people who have atrial     fibrillation (AF) and have undergone a successful procedure called ablation to eliminate or     substantially reduce the arrhythmia. AF is normally associated with an increased risk of     stroke which in many patients can be prevented with appropriate blood thinner therapy. This     trial will compare a strategy of oral anticoagulant therapy after successful ablation to     therapy with an aspirin per day.   "
85355|NCT02168816|"     The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and     treatment of diabetic foot infections state that for the treatment of diabetic foot     osteomyelitis No data support the superiority of any specific antibiotic agent or treatment     strategy, route, or duration of therapy. Traditionally, osteomyelitis has been treated with     a long course of intravenous antibiotics, generally six weeks. Oral antibiotics with high     bioavailability and adequate bone penetration have been shown in published studies to be     effective for the treatment of osteomyelitis.      The investigators propose to conduct a prospective, single-center, randomized, open trial at     Loyola University Medical Center (LUMC) comparing the efficacy of oral antibiotic therapy to     intravenous (IV) antibiotic therapy for the treatment of diabetic foot osteomyelitis. The     investigators hypothesize that oral antibiotic therapy is equivalent to IV antibiotic     therapy.      Bone/tissue cultures are obtained for all patients for clinical purposes and are sent to     pathology for histologic examination and to the clinical microbiology laboratory for culture     and susceptibility.      Patients will receive six weeks of IV or oral antibiotic therapy depending upon their     randomization group. Primary outcomes at six months clinical follow-up will include: (i) no     evidence of bone infection and (ii) resolution of ulcer.   "
85356|NCT02168803|"     The main purpose of this study is to measure how much of the drug gets into the blood stream     and how long it takes the body to get rid of it when given once a day for 12, 24, and 52     weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream.     Information about any side effects that may occur will also be collected.      This study will also evaluate how the study drug reacts in the body when given once a day for     12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is     complete. The relationship between study drug and the results from the how the study drug     reacts in the body may be explored, if needed.   "
85357|NCT02168790|"     The investigators aimed at developing a technique to apply amniotic membrane to a diseased     ocular surface without surgical intervention (sutureless amniotic membrane transplantation).     This system needs to be concordant with laws and guidelines for the use of medical and     pharmaceutical products.   "
85358|NCT02168777|"     Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refamentinib     through a dose escalation study, all tumor types that meet certain inclusion/exclusion     criteria can be entered.      After the recommended dose is determined, the Phase II portion of the study will evaluate     tolerability and efficacy of the combination treatment in patients with breast cancer, lung     cancer, or colorectal cancer, respectively.   "
85359|NCT02168764|"     The primary objective of the study is to demonstrate the safety and efficacy of SPG     stimulation with the ATI Neurostimulation System when used to treat acute cluster attacks in     chronic cluster headache patients.   "
85360|NCT02168751|"     Lung ventilation required for lung resection surgery induces a proinflammatory response     including cytokine production and recruitment of leukocytes and macrophages in the lung     associated with postoperative complications, mainly acute lung injury (ALI). The     lung-protective ventilation has been shown reduce this inflammatory response and play a     protective role against ALI, even though it is unclear the role of intravenous and     inhalational anesthetic agents in immunomodulation of the inflammatory response during lung     ventilation and its possible protective role against ALI. This study aims to determine the     effect of anesthetic agents on markers of lung inflammation, the mechanisms of oxidative     stress and ischemia-reperfusion, and assess the relationship between these mediators and     postoperative morbidity defined as percentage of postoperative lung complications (ALI /     ARDS, pneumonia and atelectasis), length of stay in ICU, hospital stay and mortality at 30     days. The investigators hypothesis, based on results of our group in animal research, is that     inhalants cause a lower proinflammatory response to intravenous agents for lung resection     surgery.      A clinical trial is design with two groups (propofol, sevoflurane) managed all with lung     protective ventilation, in which the markers will be measured before and after one-lung     ventilation in both lungs and in plasma before, during and after one-lung ventilation.     postoperative lung complications, ICU and hospital stay and 30 days mortality.   "
85361|NCT02168738|"     The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway     in human by using 13C labeled molecules.      The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this     research is to confirm that some lipidic forms are best carriers for the cerebral     incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.   "
85362|NCT02168725|"     The main objectives of this study are to determine the safety profile of briciclib, an     experimental anti-cancer drug, as it is administered intravenously once weekly as escalating     doses in adult patients with advanced cancer and solid tumors, and to determine the highest     dose of briciclib that can be safely given. Secondary objectives are to determine how the     amount of briciclib in circulation changes over time and how much briciclib gets into the     urine for excretion, and to document potential anti-tumor effects of briciclib.   "
85363|NCT02168712|"     Exercise therapy increase functional capacity improving the morbidity and mortality of     patients with cardiovascular disease. Moderate continuous training is the best established     training modality for this patients. However, a body of evidence has begun to emerge     demonstrating that high intensity interval training obtained better results in terms of     morbidity and mortality.      The purpose of this randomized clinical trial was to determine the effect of two types of     exercise training: moderate continuous training vs high interval training on functional     capacity and quality of life as well as verify the safety in its application.      We included 72 patients with coronary artery disease by assigning one of the training     modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of     life as well as a record of adverse events.   "
85384|NCT02168439|"     The objective of this research study is to show superiority of intranasal dexmedetomidine to     intranasal midazolam as anxiolysis prior to pediatric laceration repairs.   "
85385|NCT02168426|"     The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the     incidence of bowel obstruction and to evaluate the incidence of all serious adverse events     (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days     postoperatively.   "
85364|NCT02168699|"     Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete     anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve     is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while     there is limited information regarding ultrasound imaging of the musculocutaneous nerve in     children.      The aim of this prospective imaging study is to investigate whether musculocutaneous nerve is     visualized in childhood with the use of ultrasound imaging or not. A secondary aim of this     study is to assess the percentage of its visualization according to the age.      Parental written informed consent is obtained from all participants. The children are divided     into three groups according to their age: Group 1, with infants aged less than 12 months;     Group 2, with toddlers and preschoolers; and Group 3, with school-aged children (6.5-12     years).      Children are placed in the supine position with the involved arm abducted at 90° and the     elbow flexed at 90°. The linear probe of a portable ultrasound machine is placed at the     axillary region, perpendicularly to the axillary artery. The musculocutaneous nerve is     searched near the axillary artery (proximally) and its course is followed distally (into the     coracobrachialis muscle). Its sonographic detection is recorded in these two sites, both     proximally and distally.   "
85365|NCT02168686|"     The purpose of this study is to test the safety and primary efficacy of a gene transfer     vector (drug) for the treatment of alpha1-antitrypsin (A1AT) deficiency. The study uses an     experimental drug (ADVM-043 also known as AAVrh.10halpha1AT) to deliver a gene (gene     transfer) to treat the signs and symptoms of A1AT deficiency. Unlike other drugs, this one is     made of a virus called adeno-associated virus (AAV). In this study, the AAV acts as the     vehicle used to carry the A1AT gene into the lung cells so it can treat the cells.   "
85366|NCT02168673|"     Cigarette smoking is the major risk factor for developing chronic obstructive pulmonary     disease (COPD). Patients with COPD have difficulty clearing mucus and debris from their     airways. Even smokers who have not developed COPD may have difficulty clearing the airways.     This is partly because smoking impairs the function of cilia, tiny hairs lining the airways     that sweep out mucus to keep the airways clean. The investigators have found that smoking     reduces the length of cilia, which may contribute to the worsened cilia function in smoking     and COPD. This is true even in smokers who show no signs of lung disease. The investigators     believe that smoking affects levels of genes in lung cells, resulting in shorter cilia.   "
85367|NCT02168660|"     Vitamin D deficiency is extremely common in obese youth. In our obese population followed in     the Endocrinology clinic at CMC, vitamin D levels were inversely correlated with a measure of     insulin resistance. We propose to show that correction of vitamin D levels in obese children     and adolescents improves their insulin sensitivity. Obese youth presenting to the Center for     Obesity and its Consequences on Health (COACH) clinic will be randomized to receive either     the most recent Institute of Medicine (IOM) recommendations of minimum D3 dose of 600 IU/day     (1), or receive higher doses of D3 such that the blood levels of vitamin D will be brought to     a target level in either the low part or high part of the normal range. The goal is to     determine if correction of vitamin D deficiency will improve insulin sensitivity in this     group. Secondary goals include determining whether correction of vitamin D deficiency in     obese adolescents and children results in less weight gain, and determining the amount of D3     required to correct vitamin D levels in this population.      Our specific hypotheses are as follows:      Hypothesis #1 Obese youth treated with Vitamin D3 who achieve low-normal 25-OHD levels (30-50     ng/mL) or high-normal 25-OHD levels (60-80 ng/mL) will have improved insulin resistance, as     measured by HOMA-IR, compared to those individuals with deficient 25-OHD levels (< 30 ng/mL).      Hypothesis #2 Subjects with a higher BMI will have higher Vitamin D dose requirements than     current IOM recommendations of 600 IU/day and will take a longer period of time to reach     target 25-OHD levels.      Hypothesis #3 Subjects with normal 25-OHD levels will demonstrate less weight gain compared     to subjects on the control arm.   "
85368|NCT02168647|"     Multiple studies have demonstrated a very low prevalence of women meeting physical activity     and weight gain recommendations during pregnancy. The aim of this study is to provide a     lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent     excessive gestational weight gain, decrease postpartum weight retention, and improve mental     well-being compared to usual care using a randomized controlled design in pregnant women.     Participants in the intervention group will receive behavioral lifestyle counseling and take     part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week     14 of their pregnancy to child birth. Participants in the usual care group (control) will     not receive any lifestyle counseling. Data collected from this group will be used to compare     the effectiveness of the lifestyle intervention. Unlike many studies examining diet and     physical activity factors alone, this study evaluates additional psychosocial factors such as     psychological health, self-efficacy, competence, motivation and barriers that may influence     excessive gestational weight gain. In addition, the Self-Determination Theory framework will     be used to measure how motivation and motivational interviewing strategies can help explain     changes in volitional behavior.   "
85369|NCT02168634|"     Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the     population. The patients with hypertrophic scar usually seek medical assistance not just for     the annoying appearance but mostly due to the intractable itchiness. There have been a     variety of effective methods to alter the appearance of the scar. However, the treatments for     itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat     histamine-induced itch with favorable results. In the clinical setting, however, the efficacy     of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of     this study is to conduct a randomized controlled trials about using Botox to treat itch from     hypertrophic scar.   "
85418|NCT02167997|"     To compare the safety and efficacy of treating small aneurysms with coils specially designed     for small aneurysms to historically reported rates of safety and efficacy for the treatment     of larger aneurysms.   "
92090|NCT02080676|"     Purpose of study: to check the effect of medical cannabis given for approved medical     indications on ocular parameters including intra ocular pressure, optic nerve fibers     thickness and choroidal thickness.   "
85405|NCT02168166|"     Cognitive remediation (CR) therapies refer to a number of recent developments to use     behavioural strategies to improve neurocognitive abilities and improve everyday functioning     in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study,     we aim to examine whether we can observe CR effects on measures of neuroplasticity,     cognition, and functioning when using a rigorous control comparison group. We hypothesize     that the active group will exhibit improvements in executive functioning composite scores,     improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the     placebo group.   "
85370|NCT02168621|"     Treatment directed towards the control of periodontal infections is to about 90% non-surgical     procedures. There is evidence from a large number of randomized controlled studies that the     efficacy in terms of clinical outcomes of a full-mouth ultrasonic debridement approach (FMUD)     is comparable to that of traditional section-wise scaling and root planing (SRP). A     hypothesis for the current effectiveness study is that comparable clinical effects will be     obtained with the FMUD approach as with conventional section-wise SRP, but with significantly     more favourable patient-centred and health-economic outcomes.      This randomized study involves about 100 professionals (dental hygienists) and more than 1000     patients at 45 dental clinics in the Vastra Gotaland Region, Sweden. The project not only     evaluate treatment effects in terms of pertinent clinical outcomes, it also has a strong     focus on patient-centered measures - patient-reported experience measures (PREM) and     patient-reported outcome measures (PROM) - as well as health-economics.   "
85371|NCT02168608|"     Remote ischemia precondition could protect the liver from ischemia reperfusion injury in     patients undergoing hepatectomy.   "
85372|NCT02168595|"     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single     ascending IV doses of GMI-1271 in healthy adult subjects.   "
85373|NCT02168582|"     This is an observational study that aims to characterize individual response of patients     getting physical therapy for chronic non-specific low back pain.      Participants will be classified based on a questionnaire and motor tests to investigate     whether individual improvement after physical therapy may be predicted. These observations     may help to decide which should be the preferred treatment offered.   "
85374|NCT02168569|"     This is a classical in vivo clinical trial, following World Health organization's     recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and     safety in 5 sites of the two oral ACTS artemether-lumefantrine (AL) and     Amodiaquine-Artesunate (AQ-AS), first and second line treatment for malaria in mozambique,     respectively, for the treatment of uncomplicated malaria in children aged<5 years.   "
85375|NCT02168556|"     This is a randomized controlled trial to determine if music, a video, or standard of care     will decrease anxiety in patients undergoing urodynamic testing.   "
85376|NCT02168543|"     -  Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases          new bone formation in chronic periodontitis patients        -  Till date no study has reported the effect of local delivery of ALN in chronic          periodontitis patients among smokers. Hence the aim of this study is to investigate the          clinical and radiographic effects of locally delivered ALN as an adjunct to the non          surgical treatment in smoker chronic periodontitis patients.   "
85377|NCT02168530|"     This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study of     vismodegib in patients with IPF. Eligible patients will be randomized in a 2:1 ratio to one     of two treatment arms: vismodegib or placebo. The duration of treatment will be 52 weeks.     Study drug will be administered daily by the oral route. An 8-week safety follow-up period is     included for all patients who receive at least one dose of study drug.   "
85378|NCT02168517|"     The overall aim of the study is to investigate if patients with musculoskeletal chronic pain     have reduced semen quality in comparison with age matched healthy controls. Secondly, the aim     is to investigate whether overweight with or without chronic pain are related to reduced     semen quality. We will investigate semen quality in obese chronic pain patients, normal     weight chronic pain patients and in obese and normal weight healthy controls.   "
85379|NCT02168504|"     A simple, painless and reliable method to detect Parkinson's disease at an early stage is     very important to patients, doctors and researchers. Doctors want to help patients early, and     scientists want to select patients for their research who will help in development of better     drugs. We hope that the changes in electrical activity of hand muscles during handwriting     will help in early detection of this disease.   "
85380|NCT02168491|"     Premixed insulin-based therapy is a standard insulin treatment strategy in Austria. The     widespread use of premixed insulin is explained by high acceptance by health care     professionals and patients due to one single product and flexible number of injections (1-3     daily) which covers the demand in controlling fasting and postprandial glucose excursions of     most patients with diabetes. However, the use of pre-mixed insulin frequently leads to a high     insulin demand and consequently weight gain and an increased risk of hypoglycemia. Hence,     achieve good metabolic control in these patients remains a major challenge.      For those patients, the approach to treatment intensification without facing the typical     risks of insulin treatment (hypoglycemia and weight increase) is of major importance. One, so     far not exploited option may be the BIT-strategy: Basal insulin in combination with     incretin-based therapy.      Pathophysiologically basal insulin inhibits glucose production in the liver, decreases     hepatic insulin resistance and improves the function of beta cells in the postprandial state     by discharge of fasting insulin secretion. During further diabetes progression steadily     increasing HbA1c levels - despite good fasting blood glucose control - indicate the need for     additional intervention of meal-related glucose excursions. In this stage of type-2 diabetes     basal insulin can be combined with prandial (short-acting) insulin or prandial GLP-1 receptor     agonists. However, regarding important safety parameters: risks of hypoglycemia and weight     gain in the long-term treatment GLP-1 receptor agonists are beneficial.      Lixisenatide is a novel GLP-1 receptor agonist with a pronounced postprandial (PPG) effect     which fits with basal insulin mode of action primarily focused on fasting blood glucose     reduction.      Therefore 10 patients (both gender) under treatment with premixed insulin (2-3 times daily)     and HbA1c>7% will be switched to basal insulin glargine (Lantus, once daily) and GLP-1     receptor agonist Lixisenatide (Lyxumia, once daily). The investigators hypothesize that     switching from a therapy based on premixed insulin to a simple, once daily administered     combination of basal insulin plus a GLP-1 receptor agonist in patients with type-2 diabetes     not achieving therapeutic target (HbA1c>7%) is clinically feasable in an out patient setting   "
85381|NCT02168478|"     A 48 hour patch test performed in healthy volunteers to determine the presensitization     (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base),     fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium     Lauryl Sulfate) and a negative control (Saline).      The primary objective of this study is to determine if any subjects exhibit an allergic     reaction which may be indicative of a pre-existing sensitization.   "
91226|NCT02091999|"     The purpose of this study is to evaluate the safety and pharmacokinetics ASG-22CE as well as     assess the immunogenicity and antitumor activity in subjects with metastatic urothelial     cancer and other malignant solid tumors.   "
85382|NCT02168465|"     1. Design and develop web-based self-management intervention to improve catheter-related          outcomes and quality of life in people with spinal cord injury (SCI).        2. Conduct a pilot study to assess the feasibility (i.e., acceptability and usability of          the website application) and preliminary effectiveness of this new self-management          intervention.        3. Develop and test the reliability of new/modified measures (intermittent catheter          self-efficacy and self-management).   "
85406|NCT02168153|"     This study is a randomized controlled trial designed to evaluate changes in reaction times     (RTs) and response times (RespTs) following chiropractic treatment compared to controls in     the Special Forces Qualified (SFQ) population, including Special Operation Forces who are     part of the 160th SOAR regiment on flight status.   "
85386|NCT02168413|"     This study has two main goals :        -  to develop the cortcial excitbality (CE) measurement methodology using coupling between          transcranial magnetic stimulation (TMS) and physiological recordings such as          electroencephalography (EEG) and electromyography (EMG),        -  to automatize these measurements using robotized TMS.      Assessing CE is a preliminary and crucial step in any TMS protocol, in either fundamental or     clinical research. It is an important indicator which determine the stimulation power applied     on the cortical target during the TMS experiment, or during the rTMS cure (patients). CE is     in general measured on the motor cortex using EMG activity as the main indicator of the     system's response, whatever the real cortical target is located. The present study thus     propose to generalize this measurement on other cortical areas in link with the actual     targets, and using other external recordings such as EEG. Moreover, as neuronavigation     systems significantly improved TMS precision in the past years, CE measurements could     significantly gain to become fully automatized using robotized TMS.   "
85387|NCT02168400|"     Long-term abstinence from alcohol is supported by a compensatory mechanism in functional     brain connectivity, a potential brain biomarker that could be an intervention target. These     findings provide a compelling case to explore whether this brain biomarker can be modulated     to enhance patients' ability to remain abstinent. There is a need to investigate methods that     can be used to increase functional brain connectivity. The overall objective of this proposal     is to enhance brain functional connectivity in short-term abstinent alcoholics as a     therapeutic intervention that supports abstinence.   "
85388|NCT02168387|"     The purpose of this study is to evaluate whether a therapy that uses a machine called a     continuous high frequency oscillator (CHFO) is more successful at removing mucus than     medications that thin out the mucus.   "
85389|NCT02168374|"     This study assessed the clinical performance of a resin-modified glass ionomer cement     containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.   "
85390|NCT02168361|"     Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis     comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label     combination of simeprevir+ sofosbuvir without Ribavirin.   "
85391|NCT02168348|"     The investigators set out to determine whether malnutrition delayed healing of foot lesions     in diabetic patients.   "
85392|NCT02168335|"     Gingivitis is defined as inflammation of the gingiva. It is a common disease that is     prevalent in both children and adults, and in both genders . The primary cause of gingivitis     is plaque accumulation due to poor oral hygiene; however, gingivitis may result from many     varied aetiological factors. Gingivitis is characterized by red, swollen, spongy gums that     bleed easily . Current conventional treatment of gingivitis involves removal of plaque and     the use of an antimicrobial mouthwash. Mouthwashes containing chlorhexidine gluconate are     most commonly prescribed, however these have certain adverse effects. Ora-saltsTM is a     commercially available mouthwash composed of natural sea salt, Arnica montana 30 centesimal     (C), Echinacea angustifolia 30C, Staphisagria 30C, Phosphorus 30C, Hepar sulph 30C, cinnamon     and liquorice. To date there is no research on the use of OrasaltsTM in the treatment of     gingivitis. The aim of this study is to determine the efficacy of OrasaltsTM in the treatment     of gingivitis using the Modified Gingival Index (MGI) and the Quantitative Gingival Bleeding     Index (QGBI).   "
85393|NCT02168322|"     Membrane modifecation:      Guided tissue membrane perforations may serve as a more biologic scaffold that could allow     for the free passage of biologic mediators from the periosteum and overlying gingival     connective tissue into the periodontal defects.      Study hyposethis:      To test this hyposthesis, this study was designed to evaluate levels of vascular endothelial     cell growth factors and platlet derived growth factors in gingival crevicular fluid (GCF)     during the early stages of healing for localized intrabony defects treated with modified     perforated membranes (MPMs), occlusive membranes (OMs) as compared to open flap debridement     control (OFD).      Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this     prospective, randomized and single blinded trial. Each patient contributed one interproximal     defect that was randomly assigned to experimental modified perforated membrane group (10     sites), occlusive membrane group (10 sites) or open flap debridement control (10 sites).     Plaque index, gingival index, probing depth (PD), clinical attachment level (CAL) and the     intrabony depth of the defect (IBD) were measured at baseline for patients enrollment.     Gingival crevicular fluid (GCF) samples were collected on day 1 and 3, 7, 14, 21, and 30 days     after therapy. The primary outcome variable was the change in VEGF and PDGF-BB levels for     sites treated by MPMs or OM compared to that of the OFD treated cases.   "
85394|NCT02168309|"     This study's aim is to determine whether oral extended release nifedipine is superior to oral     labetolol for the management of postpartum severe hypertension, specifically time to achieve     goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended     release nifedipine is superior to oral labetolol for achieving goal blood pressure in the     postpartum period.   "
85395|NCT02168296|"     The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two     different matrices, at different dose levels.   "
85466|NCT02167360|"     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and     safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following     sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary     Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary     follow-up is 1 year from cell infusion. Safety will be assessed until the end of the     treatment and primary follow-up phase.   "
85407|NCT02168140|"     This phase I trial studies the side effects and best dose of CPI-613 when given together with     bendamustine hydrochloride in treating patients with relapsed or refractory T-cell     non-Hodgkin lymphoma or Hodgkin lymphoma. CPI-613 may kill cancer cells by turning off their     mitochondria, which are used by cancer cells to produce energy and are the building blocks     needed to make more cancer cells. By shutting off mitochondria, CPI-613 may deprive the     cancer cells of energy and other supplies needed to survive and grow. Drugs used in     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving CPI-613 with bendamustine hydrochloride may kill more cancer     cells.   "
85408|NCT02168127|"     The purpose of this six month, open-label study is to evaluate the long-term safety and     efficacy of PRC-063 in adults and adolescents with ADHD.   "
85409|NCT02168114|"     The purpose of this research study is to determine the potential of Optical Imaging     techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected     exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms     before any imaging techniques are performed. Boys with Duchenne Muscular Dystrophy will only     undergo the imaging techniques without exercise.   "
85396|NCT02168283|"     INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease     patients. However, cardiovascular disease remains the major cause of morbidity and mortality     in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is an     important cause of cardiovascular disease in PD patients.      OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood     pressure, hospitalization and cardiovascular morbidity in PD patients.      HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could     improve the clinical outcome of PD patients.      DESIGN & SUBJECTS This is an open label randomized control trial. The investigators plan to     recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2     liters. Patients will be randomized to active fluid management (treatment arm) or     conventional management (control arm).      STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy.      INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling,     diuretics, and intensive dialysis regimen. For the control arm, patients will only receive     dietary counseling. Patients will be followed for one year.      MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of     hospitalization for all cause, and hospitalization for cardiovascular disease during the     study period.      DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization     data will be compared by non-parametric Mann Whitney U test.      EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid overload     in PD patients.   "
85397|NCT02168270|"     This phase I trial studies the side effects and best dose of ascorbic acid when given     together with temozolomide in treating patients with high-grade glioma that has come back.     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Ascorbic acid contains ingredients that may prevent or slow the growth     of high-grade gliomas. Giving temozolomide with ascorbic acid may kill more tumor cells.   "
85398|NCT02168257|"     The purpose of this study is to determine if the RAM cannula is as effective as conventional     binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.   "
85399|NCT02168244|"     Injectable biologic drugs are used as a treatment of psoriasis. These injections can     sometimes be associated with pain. In this study the investigators aim to reduce the pain by     applying heat or ice to the skin 2-3 minutes before injecting the drug, and to compare the     pain to injection without any heat or ice.   "
85400|NCT02168231|"     Incisional hernia is the most frequently seen long term complication in surgery causing much     morbidity and even mortality in patients. Despite studies on the optimal closing technique     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20%.     It has been established that implementing a mesh reduces recurrence of the incisional hernia     but still the results of repair are often disappointing. Incisional hernias can become     increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy,     fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair     the incisional hernia by means of a synthetic mesh and other augmentation tools need to be     implemented.      In the recent years the use of biological meshes has been gaining popularity. Recent reports     of the use of collagen-based prosthesis have suggested that they support new vessel growth,     do not excite a significant foreign body reaction, form fewer adhesions, are well     incorporated into host tissues with minimal wound contraction, and can be used in grossly     contaminated wounds with fewer infective complications. Biologic meshes are harvested from a     source tissue and processed for medical use but they vary widely in their processing methods.     They include tissues of human or animal origins, both chemically cross-linked and non     cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current     studies investigating the effectiveness of these meshes are small and have short periods of     follow-up. These shortcomings can be explained to high cost of the meshes and unclear     indication when to use a biological mesh.      The aim of this study is to investigate the short and long term effects of the Strattice     biological mesh. The investigators will also inquire why a biologic mesh was used and what     the direct and indirect costs were.   "
85419|NCT02167984|"     Esophageal dysmotility due to immaturity could promote impaired bolus transit during     esophageal swallow events,thus influencing gastroesophageal reflux (GER) clearance.      Aim of this study was to describe esophageal bolus transit characteristics during swallow and     to evaluate the relationship between esophageal swallow (ES) and GER in newborns with     gastroesophageal reflux disease symptoms using multichannel intraluminal impedance.      The simultaneous analysis of swallow and GER events in newborns undergone MII/pH monitoring     could provide useful information to better understand the physiopathology of gastroesophageal     reflux disease (GERD) and could help clinicians to identify newborns with prolonged     esophageal clearance time, making the recommendations for further tests and the therapeutic     approach more accurate   "
85420|NCT02167971|"     The purpose of this study is to determine whether repetitive Transcranial Magnetic     Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse     axonal injury(DAI) after Traumatic Brain Injury(TBI).   "
85421|NCT02167958|"     The purpose of this study is to determine whether stem cells collected from a donor's blood     stream will be as safe and effective as using bone marrow collected from a donor's pelvic     bone.   "
85422|NCT02167945|"     The purpose of this study is to evaluate Long-term Outcomes following treatment with     ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C     Virus (HCV) Infection   "
85401|NCT02168218|"     This study aims at assessing the hypothesis that dietary protein content is a major factor     regulating lean body mass gain and energy expenditure during overfeeding, and thus long term     body weight gain      To test this hypothesis, healthy normal weight male and female subjects will before and after     a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5%     total energy) or a high (20% total energy) protein intake. Each subject will be studied with     both hlow- and high protein diets according to a randomized, crossover study. On each     occasion the following measurements will be done in basal conditions (after 2-day     isoenergetic, controled diet) and at the end of the 7-day overfeeding:        -  whole-body protein turnover, oxidation and synthesis in fasting conditions and fed          conditions (13C-labelled leucine)        -  intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)        -  Energy metabolism in fasted and fed conditions (indirect calorimetry)        -  plasma concentration of glucose, non-esterified fatty acids, total triglyceride,          very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone          (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein          (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and          low-protein sucrose overfeeding on whole body protein synthesis will be compared using          two-way ANOVA; relationships between changes in whole body protein synthesis on one          hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and          plasma concentration of metabolic variables on the other hand, will be evaluated by          linear regression analysis   "
85402|NCT02168205|"     This study will evaluate the effect of food and smoking on healthy older subjects taking     pomalidomide.   "
85403|NCT02168192|"     The purpose of this study is to assess the utility of training in Breaking Bad News (BBN)     skills. We hypothesize that given little or no formal training in breaking bad news,     obstetric providers will benefit from a curriculum of teaching breaking bad news techniques,     but will benefit more from a simulation teaching technique than from a lecture in breaking     bad news techniques.      The investigators also hypothesize that providers who have undergone breaking bad news     simulation will receive improved scores after the simulation debriefing compared to their     pre-simulation scores, and their improvement with be greater than the control group.   "
85404|NCT02168179|"     This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in     patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy,     painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy     may be a better treatment for radiation dermatitis.   "
85413|NCT02168062|"     Randomized, phase 2 study to assess the impact of the multi-disciplinary STAND clinic on     changes in key metabolic parameters, quality of life, and patient satisfaction among men     receiving androgen deprivation therapy for prostate cancer. Standard-of-care therapy will     consist of every 3-month visits comprised of review of medical history, toxicity assessment,     and lifestyle modification counseling provided by a dietitian and exercise physiologist on an     as-needed basis. Men randomized to participate in the multi-disciplinary STAND clinic will     have, in addition to every 3-month visits with an individual health care provider, structured     and individualized exercise and dietary counseling.      A separate non-randomized patient cohort of 20 patients who are receiving concurrent     chemohormonal therapy will be enrolled in parallel.      The primary hypothesis of the study is that active participation in a multi-disciplinary     clinic, as compared to current standard-of-care, will lead to lessened impact of androgen     deprivation therapy on metabolic parameters and improved quality of life.   "
85414|NCT02168049|"     The investigator goal is to test a new device to see if it can provide continuous and     simultaneous monitoring of heart and lung function.   "
85415|NCT02168036|"     The purpose of this protocol is to obtain biologic materials from the mediastinal lymph nodes     from patients with lung disease and mediastinal lymph node involvement in order to: (1)     develop a better understanding of the cause and development of lung disorders involving the     mediastinal lymph nodes; (2) identify biologic parameters that help diagnose and predict the     behavior of human lung diseases; and (3) identify individuals who will be suitable candidates     for other protocols such as those involving investigational new drugs.   "
85416|NCT02168023|"     Surgical site infections (SSIs) constitute an important medical and socioeconomic problem     worldwide. Despite the fact that the risk factors for SSIs were identified and the     continuously increasing medical knowledge in the fields of tissue engineering, molecular     biology and microbiology facilitated the development of numerous new recommendations and     methods for management, in many cases the available options for successful treatment of     post-operative wound infections remain limited. Non-treated or inappropriately treated SSIs     often lead to necrosis of the surrounding tissues, wound dehiscence, formation of fistulas,     or become sites of origin for systemic infections. Patients are exposed to risk of further     complications and hospitalization time extends resulting in increased total treatment costs.     Treatment prolongation affects also the quality of life and psychosocial functioning of     patients with impaired wound healing. Considering the arguments above, appropriate prevention     and management of infected post-surgical wounds is currently one of the priorities for the     majority of invasive medical disciplines.      Obstetrics constitute a field of medicine in which the issues associated with wound healing     are particularly relevant. According to the literature data wound infections occur in     approximately 1.8-11.3% of women undergoing caesarean section.      Dialkylcarbamoyl chloride (DACC) is a fatty acid derivative that irreversibly binds     microorganisms to the dressing fibres as a result of hydrophobic interaction. As the     mechanism of DACC action is solely physical no chemical agents are released into the wound     bed and the dressing could be safely used by women during puerperal period.      The purpose of this randomized controlled study is to compare the effect of DACC impregnated     dressing and standard surgical dressing in the prevention of SSIs in adult women following     caesarean section. This study will also evaluate pre-, peri- and postoperative risk factors     of SSIs and analyze health economics of DACC impregnated dressings for prevention of     post-cesarean wound infections.   "
85417|NCT02168010|"     The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in     patients with low back pain for 3 months after surgical treatment. It is a randomized,     placebo-controlled, double blind, multi-center phase III clinical trial. Patients with     chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and     70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are     divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with     Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4     measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required     to score their pain with pain VAS and to have regular blood, urine, and renal/liver function     tests. The changes of the pain VAS at day 21 are compared between groups.   "
85443|NCT02167659|"     Based upon the current state of science, the investigators are proposing to conduct a     randomized clinical trial in which participants are randomized post-surgery to either BIS or     circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS     group have an L-Dex change that is ≥6.5 units higher than the pre-surgical baseline measure,     and when patients in the tape measurement group have a volume change in the at-risk arm that     is between ≥ 5% and <10% above pre-surgical baselines (without similar change in non-at-risk     arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.   "
86872|NCT02148965|"     The Pamela Study is a clinical trial carried out during pregnancy to assess the potential     effects of physical activity during pregnancy among previously inactive women. The trial is     nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas,     Brazil.   "
85424|NCT02167919|"     Purpose: To evaluate the efficacy of prostatic artery embolization (PAE) in patients with     benign prostatic hyperplasia (BPH) and refractory lower urinary tract symptoms (LUTS) in     decreasing the volume of the prostate gland.      Participants: Study participants will be recruited from UNC Urology clinics as well as     referring providers. We will include 15 men who are experiencing LUTS not controlled by     medication with estimated prostate gland weight between 80 and 150 grams.      Procedures (methods): Enrolled patients will undergo the standard work-up for a surgical     prostate procedure. In addition, the patient's arteries will be evaluated with a pelvic CT     angiogram. Then, patients will undergo prostatic artery embolization. Follow up visits will     be scheduled at 1, 3, 6, and 12 months after the procedure.      At the end of the follow-up period, if reduction in prostate gland size has made the patient     eligible for transurethral therapy, they may proceed to such procedure or elect to undergo no     further surgical procedure, depending on residual symptoms. Similarly, if insufficient gland     size reduction has occurred, the patient may elect to pursue OP or no further procedure if     they are no longer bothered by LUTS.   "
85425|NCT02167906|"     Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the     general population, mainly due to cardiovascular diseases. OA patients without cardiovascular     risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular     mechanisms are still not well known, the structure and function of the vessel wall can be     affected by several inflammatory and metabolic parameters during OA.These functional and     structural changes of the arterial wall leads to arterial stiffness, measured by the     pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness     and has been shown to have predictive value for morbidity and mortality. In our study, we     planned to compare arterial stiffness in OA patients with healthy subjects.   "
85426|NCT02167893|"     The purpose of this survey is designed to evaluate the efficacy and safety of long-term use     (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg     injection kit) in prostate cancer participants in daily medical practice.   "
85427|NCT02167867|"     The purpose of this study is to test the ability of the lay end user to understand the     information contained in the User's Guide; to correctly identify patients who are suitably     qualified to receive treatment; and to correctly administer the treatment with the Erchonia     ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter     setting.   "
85428|NCT02167854|"     This is a Phase I study. The purpose of this study is to determine what is the best dose of     the study drug BYL719 in combination with the study drug LJM716 and traztuzumab (Herceptin®).     The study will test the safety of the combination of these three drugs, and to find out the     effects, good and/or bad, that these three drugs have on the patient and breast cancer.   "
85429|NCT02167841|"     Background: The incidence of breech presentation in pregnant women is 4%. The situation can     be treated by two methods. The first is a version of the fetus from breech presentation to     head presentation, which can be performed in several ways, such as, an action called EXTERNAL     CEPHALIC VERSION as well as the Knee-Chest position by the pregnant mother and the second is     a cesarean section. In this study we wish to investigate if the Knee-Chest position is as     effective as the ECV action and as a result to decrease the need for ECV.      Hypotheses: According to our assumption, the Knee-Chest position can reduce the need for the     ECV action.      Objectives: Investigate whether daily Knee-Chest position is as effective as ECV.      Methods: The investigators will conduct a randomized clinical trial study. Every pregnant     woman in a breech presentation with a singleton between weeks 28-32 will be randomly assigned     into one of two groups. In the first group the women will perform daily the Knee-Chest     position between weeks 32-37. In week 37 the investigators will check via ultra sound if     there was a successful version (if not, the woman would go to ECV) in the second group we     will perform ECV without doing maternal Knee-Chest position before. Every woman will fill a     questionnaire which includes gynecological history and details regarding the degree of     persistence and performance of the activity. At the end of this process the investigators     will analyze the results and will come to the conclusions.      Significance: With ECV there are number of risks and complications such as fetal distress,     placental abruption, rupture of membrane, amniotic fluid embolism or damage to the uterus.     The frequency of these complications is 1%-2%. If it is discovered that the Knee-Chest     position is effective as the ECV action, the investigators will recommend every patient to     persist with this position and avoid the ECV action and the risks it entails.   "
85430|NCT02167828|"     Prior research has documented serious health, mental health, and social-behavioral issues     among people living with HIV (PLH) in St. Petersburg. The investigators have established that     PLH are clustered in friendship groups with other HIV+ persons and that an intervention     delivered to groups composed of HIV+ men who have sex with men (MSM) who were friends in real     life reduced mental health distress more than individual counseling. Specific aims of the     collaborative mixed-methods, qualitative/ quantitative research are to: (1) identify     facilitators and barriers of medical care attendance and ART adherence among PLH in St.     Petersburg; (2) integrate these data into an intervention designed to increase HIV care     attendance, retention, and adherence; (3) carry out a test-of-concept pilot study that     recruits groups of PLH friends and delivers an intervention to intact PLH friendship groups     to encourage mutual social support for attending medical appointments and adhering to HIV     care; and (4) evaluate the effects of the intervention on both behavioral and biological     measures, including viral load. These specific aims will be achieved by research carried out     in two phases:      In Phase I, we will conduct in-depth interviews with 60 PLH and key informants in St.     Petersburg purposively selected to include HIV+ persons in and not in medical care, adherent     or not adherent to ART, and including men and women representing diverse exposure risks.     In-depth interviews will be analyzed to identify factors associated with attending or not     attending care and adhering or not adhering to ART, as well as identifying how HIV+ friends     can support one another in HIV care entry, retention, and adherence.      In Phase II, the investigators will undertake a randomized intervention pilot study in which     20 groups of PLH friends are recruited by enrolling a PLH seed who is not reliably in care or     is ART nonadherent and then recruiting all friends known by the seed to also be HIV+. A     7-session group intervention will be undertaken with all members of the friendship groups in     the experimental condition to increase care and adherence-related social support,     problem-solving, and mutual assistance for care. Baseline to 6-month followup data will     determine whether the intervention produces greater improvement than found in the comparison     group in care attendance and treatment adherence, improved mental health, lower substance     use, and lower HIV viral load.   "
85431|NCT02167815|"     This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of     Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance     of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory     and granulating stages of the wound healing process.   "
85432|NCT02167802|"     Community bacterial infection remains to this day a common cause of morbidity and mortality     in children, which preventability is a challenge for clinicians. In a previous work, the     investigators found that 76% supported children admitted to the ICU for severe bacterial     infection were appraised as suboptimal and significantly associated with an increased risk of     death. In this context, the investigators seek to identify indicators of extractable data     PMSI and SNIIR -AM associated with a higher risk of suboptimal early taking care of children     with severe bacterial infection in order to combine them and use them as a score or decision     tree that the investigators will validate data from a national prospective multicenter study     including 512 children admitted to the ICU for severe infection. The investigators then     propose a score associated with a risk of suboptimality care to evaluate the performance of     the healthcare system .   "
85434|NCT02167776|"     Male circumcision has been demonstrated by three randomized trials to be a highly effective     method of HIV prevention, leading the World Health Organization to recommend its widespread     implementation. The investigators' prior work in Tanzania has shown that the acceptability     and uptake of male circumcision depends highly on religious beliefs. The investigators     hypothesize that the uptake of male circumcision can be increased in villages in which male     circumcision is offered in conjunction with church-based teaching and practice, compared with     villages in which male circumcision is not promoted through churches.      The investigators will conduct a community randomized trial in rural Tanzania, where the     government is systematically providing free male circumcision via campaigns in villages in     which rates of circumcision are low. Prior to the start of the campaign, villages will be     randomized to receive or not to receive church-based and culturally-informed promotion of     male circumcision. All villages will receive the standard non-church-based health education     that accompanies male circumcision campaigns.      The investigators will compare rates of male circumcision, both by self-report and by     demographic data collected at the time of circumcision, among men and boys before and after     the campaign in intervention villages with church involvement versus control villages without     church involvement.   "
85435|NCT02167763|"     The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low     Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the     TCu380.   "
85436|NCT02167750|"     The primary purpose of the research is to test the short-term effects of the consumption of     beverages containing phytochemicals and caffeine on several aspects of cognitive performance.   "
85437|NCT02167737|"     This study aims to determine if a bedside decision aid used in the ED for mechanical fall     prevention can increase patient participation in management options that decrease their fall     risk. Additionally, the investigators aim to determine if there are gender differences in     patient choices in management options and accomplished goals inspired by the decision tool.   "
85438|NCT02167724|"     The aim of this study is to know the bucco-dental status of patients with schizophrenia in     Côte d'Or.      Participation in this study will last only as long as it takes to:        -  carry out a bucco-dental examination: evaluation of dental plaque and calculus        -  take a blood sample to assess needs in vitamin C (only for patients included at DIJON          CHU and CHS Chartreuse)        -  complete a 30-minute questionnaire: clinical data and answers to questions concerning          dental hygiene and eating habits.   "
85439|NCT02167711|"     The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct     cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective     internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with     intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic     cholangiocarcinoma. This study aims to study the benefits of sequential administration of     SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic     cholangiocarcinoma.   "
85440|NCT02167698|"     This study attempts to study a new ventilation mode in children with Acute respiratory     distress syndrome (ARDS). Despite decades of research, no intervention has brought about a     significant decrease in ARDS mortality. Moreover, most of the studies are adult-based and     have been extrapolated to children. Airway pressure release ventilation (APRV) mode is     hypothesized to be superior in terms of lower need for sedation, shorter duration of     mechanical ventilation, etc. It is unique and the first worldwide randomized controlled trial     on APRV mode in children.      We plan to recruit a minimum of 50 children aged (1 month-12 years) in each group. The study     is to be conducted at the Post-Graduate Institute of Medical Education and Research (PGIMER),     Chandigarh between March 2014 to March 2016. This trial would recruit children with     respiratory failure and early ARDS and, randomize them to receive either conventional     ventilation or the APRV mode. Rest of the supportive care has also been protocolized so that     both groups receive treatment as per the existing best practices in every aspect. The primary     outcome being studied is the number of ventilator-free days. The secondary outcomes include     length of PICU stay, hospital stay, organ-failure free days, 28 day & 3 month survival,     biomarkers of lung injury (IL-6, IL-8, Angiopoeitin-2, soluble-ICAM-1, etc), functional     status, Pulmonary function tests, etc. Funding request would be sent to the Indian Council of     Medical Research, New Delhi, India.      Assessing lung biomarkers like Interleukin-6 would assess the role of different modes of     ventilation in acting as triggers for multi-organ dysfunction as well as for worsening lung     injury. This pathbreaking research is likely to open up new avenues upon completion.   "
85441|NCT02167685|"     The prospective observational study is to establish a registry database to evaluate the     potential impact of prior treatment with CMX001 on the long-term incidence of specific     events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s     well as survival rates in subjects previously enrolled in selected clinical studies of     CMX001. Each Registry participant will be followed for a period of approximately 3 years from     their enrollment in the Registry.   "
85454|NCT02167516|"     Complementary and alternative medicine has been employed over thousands of years to relieve     knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been     used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may     explored its mechanism. However, presently, there is a lack of large-sample, multicenter,     randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA.     Therefore, the investigators designed a randomized, placebo-controlled, double-blind,     multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the     treatment of KOA.   "
85442|NCT02167672|"     Hysterectomy (surgical removal of the uterus) is the most common major gynaecological     operation in women in developed countries. In Queensland, 6000 women require a hysterectomy     for irregular periods, benign tumours or pelvic pain every year. Surgical approaches to     surgical removal of the uterus (womb) include Laparoscopic Hysterectomy (LH), Vaginal     Hysterectomy (VH) and Abdominal Hysterectomy through an abdominal incision (AH).      It is widely accepted that LH and VH are less invasive surgical procedures, cause less     bleeding, surgical complications and pain and are associated with quicker recovery from     surgery than the more invasive AH. In a clinical trial comparing LH and AH we recently     demonstrated that LH outperforms AH with regards to cost effectiveness causing less total     health-services cost than AH.      Implementation of LH in Queensland could save $9.8 million every year. Despite the evidence     for LH and VH, 2600 hysterectomies (43%) are still performed through an open, abdominal     incision. In brief, a common but outdated operation is still performed regularly causing not     only unnecessary pain, surgical adverse events and longer hospital stay but also increased     healthcare costs.      This study will assess reasons why a significant number of gynaecologists and patients prefer     AH over LH (Barriers to the uptake of laparoscopic hysterectomy). We will survey specialist     gynaecologists as well as patients who have had a hysterectomy for different health reasons.     Based on the information from the survey the investigators will develop an intervention to     increase the rate of laparoscopic hysterectomies in Queensland and pilot test it.   "
85444|NCT02167646|"     Sensory coverage in the finger continues to be a challenging problem. This study reports     sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps     and compares the results between the dual- and single-innervated flaps.The main evaluated     outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the     flap, fingertip pain and joint motion.   "
85445|NCT02167633|"     To determine whether stereotactic radiosurgery of metastatic spinal cord compression is     equivalent to decompressive surgery followed by external body radiation therapy to maintain     ability to walk at 6 weeks.   "
85446|NCT02167620|"     Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular     disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk     through associated metabolic side-effects. Metformin, a medication used to treat prediabetes,     and diabetes in the general population, holds promise with regard to reduction of AP-related     metabolic problems, but has not been directly tested in early episode patients beyond weight     loss, nor specifically in patients with diabetes or prediabetes and psychosis. We propose to     replicate findings that metformin can reduce weight gain, and dysglycemia uniquely focusing     on an early episode population diagnosed with prediabetes or diabetes. To help determine     long-term risk/benefit of adjunctive metformin, we propose to look at changes in abdominal     and liver fat, two well-established risk factors for CVD. Given links between dysglycemia,     obesity with hippocampal volume loss and cognitive dysfunction, we will explore if     improvements in metabolic indices are associated in changes in cognition and brain structure.   "
85447|NCT02167607|"     Primary objective is to determine the bioavailability of and characterize the kinetic profile     of target polyphenol metabolites of potatoes over 6 hour postprandial period.      Secondary objective is to assess the influence of potatoes' bioavailability and kinetic     profiles on markers of chronic diseases.   "
85448|NCT02167594|"     This study will evaluate 18F-AV-1451 for brain imaging of tau in subjects with progressive     supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.   "
85449|NCT02167581|"     Systematically compare the phenotype and genotype of epithelial odontogenic tumors in     children and adults with a clinical, radiographic, pathologic and molecular level.      Either:      establish an observatory of this multidisciplinary tumor establish a tumor bank annotated     scale unparalleled testing pathophysiological hypotheses search for prognostic factors.   "
85450|NCT02167568|"     Corpus callosum agenesis or dysgenesis (CCA) is a major brain malformation (˜1/4000 births)     presently diagnosed by prenatal ultrasonography. In about half of the cases, CCA is     associated with other anomalies (complex CCA), which usually leads to medical abortion.     Syndromes including a CCA are many (hundreds), most of which are also associated with     intellectual deficiency (ID). Several genes are involved in such complex CCA. On the other     hand, several studies pointed to the favorable cognitive outcome of individuals/fetuses with     an apparently isolated CCA (ICCA) during pregnancy in about 70% of cases. However, there are     still 30% of cases with ID or developmental delay. The precise incidence and severity of     these disorders are presently unclear. Therefore, prenatal counseling of couples facing a     prenatal diagnosis of ICCA is still elusive.      Our aims are to unravel the genetic causes of CCA by combining phenotypic and genetic     analyses in a prospective cohort of patients with CCA and intellectual disability, in order     to improve prenatal information.   "
85451|NCT02167555|"     Primary objective is to characterize the relative bioavailability and kinetic profile of wild     blueberry polyphenols over 24-hours period.      Secondary objective is to examine the relationship between bioavailability and kinetic     profile of wild blueberry polyphenols on markers of chronic diseases.   "
85452|NCT02167542|"     It has been demonstrated the application of noninvasive positive pressure ventilation (NPPV)     to assist spontaneous breathing through a face mask during fiberoptic bronchoscopy (FOB) with     bronchoalveolar lavage (BAL) in severely hypoxemic, nonintubated patients. With NPPV, FOB was     well-tolerated, significantly improved the PaO2/FiO2 ratio, and successfully avoided the need     for endotracheal intubation. Two randomized studies have provided supporting evidence that     the application of NPPV or CPAP via a face mask was superior to oxygen supplementation alone     during FOB.      For this reason patients who require FOB and are hypoxemic and/or mild hypercapnic (TcCO2 <     60mmHg) will be compared in a randomized study by comparing NPPV vs CPAP Boussignac (Vygon)     delivered through a face mask.   "
85453|NCT02167529|"     The purpose of this study is to evaluate the evolution of quality of life and voice function     with different questionnaires (VIH, SF36) before and after total thyroidectomy.   "
85455|NCT02167503|"     The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome     on patients with chronic hepatitis B.   "
85950|NCT02160990|"     The overall goal of this study was to determine the effect of exenatide on gastric emptying,     satiety and satiation in obese participants. The hypothesis in this study was that exenatide     retards gastric emptying in obese patients with baseline accelerated gastric emptying.   "
85456|NCT02167490|"     The hypothesis of this trial are that:        -  avoiding axillary surgery does not worsen the outcome of patients with small breast          cancer the absence of the pathological information on the risk of recurrence given by          nodal status is not worsening outcome of these patients        -  pre-operative imaging of the axilla can identify patients with clinically relevant nodal          burden.      The aims of this prospective randomized study are:        -  to verify whether, in presence of a negative preoperative axillary assessment, SLN can          be spared        -  to verify whether, in presence of a negative preoperative axillary assessment, the          decision on adjuvant medical treatment can be taken according only to the biology of the          tumour without the prognostic information achieved by SLNB on the nodal status        -  to verify whether, in presence of a negative preoperative axillary assessment, the          patients' quality of life can be improved by a less invasive surgical procedure.   "
85457|NCT02167477|"     An anaesthetist inserts a laryngoscope into the mouth to see the voice-box (larynx) for     tracheal intubation, when a tube is advanced into the windpipe (trachea) to protect the     airway and administer anaesthetic gases.      This study aims to compare traditional (direct view) Macintosh (MAC) laryngoscopy with Storz     C-MAC videolaryngoscopes in subjects presenting for obesity reduction surgery using a novel     photographic overlay technique to analyse the basis for any differences.   "
85458|NCT02167464|"     Comparative Effectiveness Research using an intent-to-treat approach in 8 clinics in South     Carolina. The investigators will assess 4 efficacious approaches to controlling     treatment-resistant hypertension (TRH): Aldosterone Antagonist, Referral to Hypertension     Specialist, Renin Treatment-Guided Therapeutics, and combination of Hypertension Specialist     and Renin Treatment-Guided Therapeutics. Patients with TRH are evaluated with the BpTRU     device for an accurate and representative blood pressure measure on two occasions before     entry into the study. Qualitative data from focus group discussions with practice staff, and     patient surveys and interviews will provide contextual data to help explain why some     interventions are more acceptable and successful than others.   "
85459|NCT02167451|"     The purpose is to determine if the addition of Maraviroc to a standard transplant regimen     will reduce the incidence of graft versus host disease in children and young adults after a     stem cell transplant.   "
85460|NCT02167438|"     This study is being conducted to evaluate an FDA approved device called the HEM-AVERT®     Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the     second stage of labor times.   "
85461|NCT02167425|"     To improve ART initiation among people who inject drugs, the investigators propose to develop     and pilot a multi-component Integrated Methadone and Antiretroviral Therapy strategy (IMAT)     in Dar es Salaam, Tanzania. In doing so, the investigators anticipate building a functional     model of methadone and ART integration that improves the effectiveness and efficiency of     service delivery.   "
85462|NCT02167412|"     Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve     with recumbency. Few studies have evaluated orthostatic intolerance symptoms by     electroencephalography (EEG), and none of those studies have focused on the adolescent-aged     patient. This study will compare EEG characteristics and sweat rate during head-upright tilt     (HUT) testing among patients with postural tachycardia syndrome (POTS) and patients with     syncope without POTS. Patients with POTS will also undergo a separate HUT with abdominal and     lower extremity compression. The primary aim of this study is to characterize video EEG     changes that correspond with orthostatic intolerance in youth during HUT testing. The     investigators hypothesize that the clinical encephalopathy related to POTS and referred to as     'brain fog' will have an electrographic correlate. Secondary aims include (1) EEG comparisons     of POTS symptoms with and without abdominal and lower extremity compression during HUT, (2)     correlation between sweat rate and EEG changes during HUT, and (3) analysis of EEG     characteristics that distinguish syncope with POTS from syncope without POTS. The     investigators hypothesize that POTS patients have prolonged syncopal prodromes (compared to     syncope patients without POTS) which are protective of syncope during daily activities.   "
85463|NCT02167399|"     Evidence supports the use of two dimensional video analysis to assess the presence of dynamic     knee valgus during generally used screening tasks, however there is limited evidence to     support the use of the various smart phone applications as a time and money saving option for     clinic use . Subjects that present to the clinic and display dynamic valgus at the knee     during the lateral step down test will be given the option to participate in the study. If     they consent to the study they will be evaluated with 2-Dimensional video analysis to     determine the amount of valgus present at the knee during the lateral step down test. The     subject will also have the smart phone attached to their lower leg and the amount of valgus     will be concurrently measured by the selected application. The primary objective of this     study is to determine the validity of an application on the smart phone to provide an     objective measure of dynamic knee valgus. The secondary objective of this study is to     determine the possibility of the use of the application as a source of feedback during     neuromuscular re-education training in order to decrease or eliminate a subject's dynamic     valgus collapse and subsequently decreased their risk for future injury.   "
85464|NCT02167386|"     Black men who have sex with men (MSM) have among the highest rates of new HIV infections of     any group in the United States. Developing effective HIV prevention interventions that work     with this group is a critical element of the National HIV/AIDS Strategy. In the first phase     of our study (the ethnographic phase), the investigators will carry out community-based     research that will explore structural, social and cultural factors relevant to how Black MSM     might engage with Pre-Exposure Prophylaxis (PrEP). This phase of community-based research     will inform the design of an enhanced PrEP adherence intervention, which will be subsequently     tested at a community-based health clinic in Harlem in the second phase of the project.   "
85465|NCT02167373|"     The purpose of this study is to determine whether the use of a mobile sensing platform in a     primary care setting has an effect on provider workflows, patient outcomes, patient     engagement, patient self-help behavior, health research, and total cost of care.   "
85485|NCT02167100|"     The purpose of this study is to determine linkage and retention in care in patients with HIV     infection and reasons for loss to follow up Care in a High HIV-caseload Inner City Primary     Care Practice in Sydney, Australia.      The investigators hypothesise that patients attending HHMP will have higher rates of linkage     and retention in care than the US HIV-infected population, and equivalent to Australian     modelling.   "
85467|NCT02167347|"     Aim:      To assess the feasibility of culturally adapted Family Intervention for Psychosis.      Design:      Randomized Control Trial      Setting:      psychiatric department of different hospitals      Participants:      A total of 36 caregivers of Psychosis patients will be randomized to psychological     Intervention and treatment as usual arm.      Intervention:      Culturally Adapted Family Intervention for Psychosis      Outcome measure:      Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care     Well-Being & Support(CWS)   "
85468|NCT02167334|"     the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure     Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy     compared to spontaneous breathing preoxygenation.      the hypothesis is PPV extends the residual functional capacity of lung so it provides more     oxygen during apnea.   "
85469|NCT02167321|"     The introduction of total mesorectal excision (TME) and the progress of neoadjuvant     chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced     rectal cancer. However, systemic recurrence rate is not being improved and that is considered     as the cause of unsatisfactory overall survival of patients with rectal cancer. Relatively     higher systemic relapse rate than local recurrence rate is probably due to the insufficient     control of systemic micrometastasis during adjuvant chemotherapy. The efficacy of adjuvant     combination cytotoxic chemotherapy after surgery in treatment of rectal cancer remains     controversial. In addition, preoperative radiotherapy increases surgical complication such as     anastomosis site leakage and radiotherapy itself worsen sexual and urinary function and bowel     habit which result in aggravation of the quality of life. Furthermore the preoperative     chemoradiotherapy upto 3 months not only extends treatment period but increases cost of care.     To reduce the possibility of overtreatment, it is needed to confirm that the preoperative     chemoradiotherapy is absolutely necessary to locally advanced rectal cancer patients with     safe circumferential margin (CRM) resected curatively by standardized TME operation.      In this study, investigators aim to evaluate the efficacy of adjuvant FOLFOX chemotherapy     after TME without preoperative chemoradiotherapy in patients with locally advanced rectal     cancer having spared CRM are not inferior to that of current standard treatment.   "
85470|NCT02167308|"     Background: Obesity-related diseases have a profound economic impact on health care systems.     Laser acupuncture has been shown to have beneficial effects on obesity. However, to our     knowledge, those trials were either non-randomized, non-blinded, or included low-calorie diet     control. Investigators have therefore designed a patient-assessor-blinded, randomized,     sham-controlled crossover trial to investigate the significance of laser acupuncture on     obesity.      Methods/design: One hundred and four subjects above 20 years of age with a body mass index     (BMI) of over 25 kg/m2 will be divided into two groups: experimental and control. Each     subject will receive the treatment relevant to their group three times a week for eight     weeks. After eight weeks of treatment the subject will enter a two week washout period, after     which the subjects will switch groups. Measurements will include BMI, body fat percentage,     waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold thickness, thigh     circumference, body fat, blood pressure, heart rate, hunger, and the 36-item short-form     health survey (SF-36).      Discussion: The results of this pilot study will provide the basis for future large-scale     multicenter trials investigating the effects of laser acupuncture on obesity.   "
85471|NCT02167295|"     Cancer of the oral cavity is one of the fastest growing cancers among men in Taiwan. Previous     research has established a strong link between betel quid chewing, a common practice among     Taiwanese men, and oral cancer. However, despite the strong association, no attempt has been     made to develop behavioral measures to facilitate betel quid cessation. This application     extends upon existing collaboration between MD Anderson and China Medical University Hospital     (CMUH) and seeks to characterize betel quid chewers and their withdrawal symptoms, in order     to address an urgent cancer epidemiology issue in Taiwan.   "
85472|NCT02167269|"     The investigators invented the baby enclosed afferent reservoir anesthesia circuit (Baby EAR)     which could be used safely in children between 5 and 20 kg, using a fresh gas flow of 2.5 and     3 L/min in the spontaneous breathing and controlled breathing, respectively. There has as yet     been no study comparing the minimal fresh gas flow between the Baby EAR and Jackson-Rees     anesthesia circuit (JR).   "
85473|NCT02167256|"     AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment     for malignancies because these kinases play a role in tumor invasion and proliferation.     However, the Src family kinases (SFKs) are highly expressed in brain and have major effects     on synaptic plasticity2. Moreover, the investigators have recently shown that a specific SFK,     namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß)     peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in     preclinical models. This clinical trial will test the potential benefit of AZD0530 for     Alzheimer's disease modification.   "
85474|NCT02167243|"     The purpose of this project is to evaluate the efficacy of a behavioral economic intervention     to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D.     The intervention will reinforce patients for conducting SMBG, with escalating reinforcers     provided when patients achieved sustained periods of testing at least 4 times/day at     appropriate intervals. A 6-month trial will be conducted in which 60 patients will be     randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.   "
85475|NCT02167230|"     This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to     jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary     intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial     infarction, as well as 1-year major adverse cardiovascular events(MACEs).   "
85486|NCT02167087|"     This study is a clinical feasibility trial that will contribute to the clarification of     whether sentinel node mapping with indocyanine green (ICG) provides a better basis for     staging of colorectal cancer.   "
85487|NCT02167074|"     The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue     acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G     Echotip ProCore Fine Needle Biopsy (FNB) device.   "
85488|NCT02167061|"     This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of     DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in     healthy male volunteers   "
85476|NCT02167217|"     While it has been known for many years that corticosteroid use benefits boys with Duchenne     Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4     years of age. The primary reason for the delay is that daily corticosteroid use has many side     effects including short stature, obesity, and osteoporosis. A recent randomized blinded study     of weekend oral corticosteroid use over one year showed equal improvement in strength with     fewer side effects, particularly as related to growth and cushingoid changes. The     investigators will test the efficacy of oral weekend corticosteroid use in infants and young     boys with DMD who are under age 30 months. The investigators have demonstrated that the     Bayley-III Scales of Infant development shows that infants and young boys in this age group     who are untreated decline in abilities when compared to their peers. Here, in this Phase 2     historically controlled trial, the investigators will use these two measures and treat boys     at five Muscular Dystrophy Association-DMD centers   "
85477|NCT02167204|"     This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission     tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with     brain tumors. Comparing results of diagnostic procedures done before, during, and after     treatment may help doctors measure tumor growth and plan the best treatment.   "
86873|NCT02148952|"     The purpose of this study is to measure the impact of a checklist-based childbirth safety     program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal,     and newborn harm in institutional deliveries in north India.   "
85478|NCT02167191|"     It is widely known that exercise improves general fitness and that fitter patients recover     more easily from illness and surgery. Conversely, unfit patients have a significantly higher     morbidity and mortality after surgery and a longer inpatient stay. This will become     increasingly important in an aging population as baseline fitness generally declines with     age.      One method of improving cardiovascular fitness is by using low intensity endurance training     programmes, a disadvantage of these it that they can take several months to show improvement.     High intensity interval training (HIT) programmes that use short episodes of high intensity     exercise have also been shown to improve fitness. These HIT programmes have also shown     improvement in functional capacity and quality of life in patients with chronic disease. An     advantage of HIT is that improvements in fitness may occur in a shorter time than traditional     endurance training. It is also known that HIT can give superior gains over endurance     training.      The primary aim of this study is to determine whether an improvement in aerobic fitness, as     judged by a 2ml/kg/min increase in VO2peak, can be achieved within 31 days via a HIT     programme, in a group of healthy elderly volunteers.      As a secondary aim we will assess whether this programme would be acceptable to the group     studied, through determination of subject compliance and adherence to the training programme.   "
85479|NCT02167178|"     Although major surgery is often required to treat abdominal problems, there is a significant     risk of death or complication following these operations. By using ultrasound the amount and     timing of fluid patients receive during operations can be optimised and the risk of surgery     reduced. However, little is known about the exact changes in blood flow in the small vessels     of the body in response to fluid. A greater understanding of this may allow for more     appropriate care of patients undergoing this type of surgery in the future.      In this study of healthy volunteers we will attempt to better understand how fluid     administration guided by ultrasound effects blood flow in large and small vessels, by using     two different techniques of ultrasound imaging. A narrow bore (approximately 4-5mm diameter)     ultrasound probe will be passed through the nostril and mouth to rest within the oesophagus     allowing measurement of blood flow in the main artery, while a second probe will be rested on     the volunteer's abdomen and used to record changes in blood flow in small liver blood     vessels. Comparison of these two techniques during the administration of fluid will allow us     to better understand the relationship between large and small vessel blood flow.      Because different types of fluid may behave in different ways, we will test the effect of two     types of fluid commonly used in clinical practice; `normal` saline solution and gelofusine.   "
85480|NCT02167165|"     This study tested the hypothesis that response to digoxin is modulated by single Nucleotid     Polymorphism (SNP):        -  Multi Drug Resistance (MDR1) gene haplotypes and Solute carrier organic anion          transporter family member 1B3 (SLCO1B3) gene Polymorphism and their role in the response          to treatement.        -  Aldosterone synthase (CYP11B2) gene and sodium channel, voltage-gated, type V alpha          subunit gene (SCN5A) correlated with atrial fibrillation and their roles in response to          digoxin.   "
85481|NCT02167152|"     The purpose of this study is to learn about the impact of ischemic preconditioning in     reducing contrast induced kidney damage in people with pre-existing kidney problems who are     undergoing cardiac catheterization procedures.   "
85482|NCT02167139|"     This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate     the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to     Humira® in subjects with moderate to severe RA despite MTX therapy.   "
85483|NCT02167126|"     Kinesio Taping (KT) is used often, but there is little scientific information on its effect.     The aim of this study was to evaluate the effects of KT on knee extension force among soccer     players. KT (K-Tape®) and Micropore (3M®) were applied on the right and left thighs of 34     professional soccer players (20 males and 14 females). Half of the participants had KT     applied to the left and half to the right thigh. The subjects performed two maximal isometric     voluntary contractions of the quadriceps pre, immediately post, and 24 hours after tape     application. Isometric knee extension force was measured using a load cell and the following     variables were assessed: peak force, time to peak force, rate of force development until peak     force, time to peak rate of force development and 200 ms pulse. There were no statistically     significant differences between KT and Micropore conditions or among testing sections (pre,     post, and 24h after). Therefore, taping (independently of the type of tape used or time since     application) did not affect the force-related measures assessed during maximal isometric     voluntary knee extension trials performed by healthy professional athletes.   "
85484|NCT02167113|"     This non-interventional clinical study will be conducted to prospectively collect serial     plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy.     These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant     assay, which is used as an aid in the management of HBV-infected patients undergoing HBV     antiviral therapy.   "
85516|NCT02166697|"     The purpose of this survey is designed to investigate the treatment status of hypertensive     patient with metabolic syndrome-related risk factors treated with candesartan cilexetil     tablets (Blopress Tablets), as well as to assess relationships between risk factors (example,     visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an     exploratory manner.   "
85489|NCT02167048|"     This double-blind crossover study aims to compare cognitive performance (e.g., working     memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed     with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20     mg/day of psychostimulants (psychostimulants) on: a) their current dose of psychostimulants,     vs. b) a lower-dose of psychostimulants (half of their current dose).      The investigators hypothesize that the lower-dose psychostimulants will result in better     cognitive performance than moderate-to-high doses of psychostimulants.   "
85490|NCT02167035|"     To compare Combigan BID vs Simbrinza TID in subjects currently being treated with Latanoprost     for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are currently FDA     approved as combination therapy for patients with Open-Angle Glaucoma or Ocular Hypertension.     The purpose of this clinical trial would be to assess which treatment, if either, is superior     in lowering intraocular pressure (IOP). A secondary objective is to assess the tolerability     of each drug.   "
85491|NCT02167022|"     Cerebral palsy (CP) is a non-progressive disorder caused by an insult or injury to the brain     when the brain is most rapidly developing and which results in some motor dysfunction. Causes     for the injury to the brain are numerous and can occur prior to birth, during the birth     process, or within the first few months following birth. The motor dysfunction can involve     any or all four extremities but most often affects the legs, causing abnormal ambulation. The     level of severity depends on the extent of the injury to the brain and can be mild to severe.     In severe instances, the child is dependent on others for all his/her care.      There is no known cure for CP, but physical and occupational therapies are administered in an     attempt to improve function. The frequency of these therapies varies from once a week (the     standard of care in the Western Hemisphere) to five times a week (the standard of care in     Asia and some Eastern European countries). The current understanding of brain plasticity     offers a theoretical explanation to justify the more intense approach. Active repetitive     motor skill-directed rehabilitation utilizes the plasticity of the brain and can restore some     function. Intense active physiotherapy can stimulate non-injured but 'dormant' neurons and     prevent their 'natural' degeneration in order for them to substitute for the function of     injured neurons. It is the very young brain that is most likely to respond to this therapy.      The aim of this proposal is to evaluate the effect of administering both physical and     occupational therapy five times each week for 12 weeks and compare it with the standard of     care (SOC) approach of one time each week in children between the ages of 12 months and 36     months. This is the first randomized crossover trial to both enroll this young a population     of children with cerebral palsy as well as to evaluate this approach from both the therapists     and the parents perspectives. The number of children that this study will enroll is larger     than in most CP studies. The children will be evaluated clinically with two validated     instruments, one of which was designed specifically for children with CP and is administered     and scored by certified therapists and the other which was designed for children with     developmental disabilities and is scored by the child's care provider. A sub-set of children     will have a special type of MRI to evaluate any changes in the neurological structure of the     brain.      The Department of Pediatrics at the University of Arizona recently completed a collaborative     study with the Neurologic Department at the Beijing Children's Hospital where the intense     approach of five therapies per week is the SOC. The positive results prompted another     investigation to determine if such an approach would be feasible in the United States. A     compliance rate of 81% confirmed feasibility and the perception that parents who have a child     diagnosed with CP will do whatever they can to improve their child's motor function.   "
85492|NCT02167009|"     Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track     symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.   "
85493|NCT02166996|"     A single-center, prospective, randomized comparison with blinded assessment of cosmetic     outcome.      To compare cosmetic outcome of surgical defects of head and neck, repaired with     non-resorbable monofilament sutures from the aspect of suture removal time 7 and 14 days.     Data are gathered through a standardized form at the time of surgery concerning width and     length of the surgical excisions, and if the patient has any systemic cortisone treatment or     diabetes mellitus. At the time of surgery the patients are randomised to a suture time at 7     or 14 days postoperatively and all receive the same written information about postoperative     care and restrictions.      Photographs of the scars are taken one month and one year after the procedure and rated using     a visual analogue scale (VAS) by three independent assessors blinded to the intervention and     suture time. The width of the scar is measured after one ear.      Study hypothesis is that leaving non-resorbable monofilament sutures in clean surgical wounds     in the head and neck area for up to 14 days does not lead to poor cosmetic outcome.   "
85494|NCT02166983|"     This randomized clinical trial studies cognitive enhancement program in improving cognitive     function in breast cancer survivors. A cognitive enhancement program may help improve     cognitive function in breast cancer survivors and may help doctors plan better treatment for     cognitive decline.   "
85495|NCT02166970|"     In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3     months, metallic stent performance is superior to plastic stenting for palliation with     respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of     drainage are issues that remain to be definitively decided. The optimal endoscopic management     strategy is contentious. The investigators conduct the present study to prospectively in     multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable     malignant biliary obstructions to clarify the clinical outcomes of these two deployment     methods using metallic stents.   "
85496|NCT02166957|"     Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic     approach had already been described for complex stenoses but never for disruption with loss     of tissue and SES. Patients and methods: This is a retrospective observationnal study about     patients referred for complete esophageal disruption and classified in two groups: 1/ Long     disruption (> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS     removal; 2/ Short disruption (< 5cm), consecutive to radiation therapy. All the procedures     are performed according the anterograde retrograde approach, using CO2 and under X-rays     guidance. We report the characteristeristics of the procedures, the efficacy, the time before     discharge and refeeding, the complications, and the follow-up, especially the number of     dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic     technique is safe and effective for the management of esophageal disruptions in patients for     which the surgical treatment confers a high risk of morbidity and mortality.   "
85517|NCT02166684|"     The study aims to evaluate whether do-it-yourself devices for self-measuring health     parameters by subjects can be used for obtaining useful data in scientific studies.      Besides, the study aims to evaluate if increased awareness of own health status by     self-monitoring health parameters also serves as motivational instrument for changing health     behaviour.   "
85497|NCT02166944|"     The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND)     patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related     to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS,     and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy pathway     can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation and rescue     in motor function in animal model. Tamoxifen had shown ability of enhance both proteasome and     autophagy pathway, therefore the investigators assume that Tamoxifen probably can ameliorate     TDP-43 accumulation and inclusion body formation in ALS.   "
85498|NCT02166931|"     The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective     in the promotion of resilience and resistance to stress-associated cognitive inhibition.   "
85499|NCT02166918|"     In the last decades the impact of several variables on patients' social functioning has been     investigated with conflicting findings. The involved variables might be grouped in three main     categories: a) disease-related variables; b) personal resources; c) context-related factors.     The present study is aimed to identify factors that affect most real-life functioning of     subjects with schizophrenia and to assess negative and depressive symptoms, neurocognitive     deficits and impairment of social cognition. Domains of negative symptoms and cognitive     dysfunctions most associated with impairment of real-life functioning will be identified and     appropriate data analyses will be carried out to define whether it has a direct or indirect     impact on real-life functioning. The research units of Turin and Genua will also investigate     the relationships between insight into the illness and real-life social functioning. The     research unit of Genua will evaluate prevalence and course of depressive symptoms, insight     impairment and neurocognitive deficits, and will define the relationships of these aspects     with suicidal behavior and real-life social functioning. The Naples research unit n.1 will     investigate the hypothesis that deficits of preattentive and perceptual functions underlie     impaired social cognition and negative symptoms. An electrophysiological study will be     carried out in which abnormalities of event-related components and gamma rhythm     synchronization, relevant to preattentive and perceptual stages of information processing,     will be studied as endophenotypes of the disorder.      The study will also investigate the heritability of disease-related variables by evaluating     them in non-affected, first-degree relatives of subjects with schizophrenia. The research     unit of Bari will test functionality of genetic variants relevant to dopaminergic signaling,     that might confer risk for neurocognitive and related prefrontal dysfunction assessed by     specific functional magnetic resonance imaging (fMRI) paradigms. The Naples research unit n.     6 will perform an association study between selected putative schizophrenia genes and     specific psychometric, neurophysiological and neurocognitive schizophrenia endophenotypes;     moreover, the research unit will search for de novo copy-number variations (CNV) as putative     risk factors for schizophrenia or schizophrenia endophenotypes and for de novo     protein-altering mutations that may contribute to the genetic component of schizophrenia     endophenotypes. The Naples research unit n. 5 will be responsible for defining a standardized     protocol for the assessment of medical comorbidities in subjects with schizophrenia. All     psychiatric research units will contribute to assess the role of factors related to the     context in modulating the impact of variables related to the disease on real-life social     functioning.   "
85500|NCT02166905|"     This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1     inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly     ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or     primary peritoneal cancer who no longer have evidence of disease. Antigens (such as     cancer/testis antigen [NY-ESO-1] protein) are found on many cancer cells. Vaccines made from     NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may     help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells. By     finding them, the immune system may then work to control or eliminate the remaining cancer     cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase (IDO). This     enzyme is produced by tumor cells to disable immune cells, and limit the efficacy of immune     attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC and IDO1 inhibitor     INCB024360 may generate stronger and more long lasting anti-cancer immune responses in     patients with ovarian, fallopian tube, and primary peritoneal cancer in remission.   "
85501|NCT02166892|"     Previous studies demonstrated that children served themselves more food when using larger     plates and bowels. The purpose of this study is to evaluate if self-served portions and     caloric intake in normal weight and overweight children will be influenced by a specially     designed eating plates compared to similar size normal plates.   "
85502|NCT02166879|"     The primary aim is to determine whether patients with suspected OSAHS as predicted by the     STOP-BANG questionnaire will have an increased length of stay (LOS) in the postanesthesia     acute care unit (PACU) compared with those without suspected OSAHS.      The second aim will be to determine the LOS in patients with known sleep apnea by history.     This length of stay will be compared with LOS in patient with an affirmative response to the     STOP-BANG questionnaire to determine if prior knowledge of diagnosed sleep apnea will be     associated with a lower LOS than in patients with suspected OSA.      The third aim will be to characterize the adverse clinical outcomes (respiratory,     cardiovascular, and neurological) associated with suspected OSAHS in patients who respond     affirmatively to the STOP-BANG questionnaire and in those patients with known OSA. These data     (including number of desaturations, bradypnea, brady- or tachycardia, and use of reversal     agents) will be recorded by the PACU nursing staff. Unexpected admissions to the hospital and     transfers to the intensive care units will also be measured. These data will help identify     the most critical determinants of length of stay.   "
85503|NCT02166866|"     This study defines cancer caregivers as unpaid individuals who provide physical, practical,     and/or emotional care and support to the cancer patient in the home setting. They may     participate in this study if care recipients and the caregiver are both adults (18 years or     older), with the patient having been diagnosed with cancer.The 8 intervention sessions will     target the five domains of Quality Of Life (emotional, physical, social, cognitive, and     spiritual well-being), be provided in group settings, and be delivered in two 45-minute     sessions each week over a 4-week period.   "
85504|NCT02166853|"     Numerous trials support the efficacy and safety of volatile anesthetic agents, namely     inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients.     Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and     decreases pulmonary and systemic inflammation in experimental models of acute respiratory     distress syndrome (ARDS).      The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the     effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in     patients with ARDS.   "
85505|NCT02166840|"     Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of     their jaundice with transpapillary stenting at endoscopic retrograde     cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.      Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative     stenting in patients with obstructive jaundice due to periampullary tumour obstruction.   "
85506|NCT02166827|"     To evaluate the long-term efficacy of the NeuroAD system   "
85507|NCT02166814|"     The purpose of this study is to evaluate the efficacy and safety of combination of     Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with     essential hypertension and dyslipidemia.   "
85519|NCT02166658|"     Patients suffering from histologically or cytologically confirmed stage IV lung or breast     cancer with progressive or recurrent brain metastases after prior external beam radiotherapy     will receive treatment with cabazitaxel until progression of brain metastases (BM) or     unacceptable toxicity.   "
85508|NCT02166801|"     Children with cerebral palsy (CP) have life-long motor disorders and are typically subjected     to extensive treatment throughout childhood. Despite this there is a lack of evidence     supporting the effectiveness of treatment aiming at improving motor function and activity in     daily life. The primary area of interest of this research programme is to determine the     effectiveness of an early intervention program in children younger than 12 months of age who     are at risk of developing CP. A randomised control trial is planned, addressing hand use,     mobility and communication in a home-based program. New treatment principles based on recent     knowledge of brain plasticity will be employed.      The overarching goal of this research programme is to develop and evaluate new intervention     principles for children with neurodevelopmental disorders based upon theories of early     learning induced brain plasticity. Our overall aims can be formulated as follows:      To evaluate the effects of an early intervention programme on the overall development in     children with risk of developing cerebral palsy and other neurodevelopmental disorders. The     program includes intensive intervention towards the foci: hand use, mobility and     communication in a home based program      The hypothesis is that the design of the Small-Step-Program intervention, with clear foci on     specific areas of development during different time periods and conducted in the child's home     environment, will facilitate development and be more effective than usual care.      The second hypothesis is that children learn what they practice, meaning that children will     have a more rapid development within the focus of each specific step in the training, when     compared to the, for the time being, untrained steps.      The third hypothesis is that children's ability to learn within the different steps of the     intervention programme will be influenced by the specific characteristics of any underlying     brain pathology.      The fourth hypothesis is that parents in the study group will be less stressed and can better     cope with their child's situation than parents to children receiving usual care. Thus, the     tools provided within the Small-Step-Program intervention, like education, supervision and     feedback of how to practice communication and task performance will make parents more able to     cope with the child's delayed development.   "
85509|NCT02166788|"     BACKGROUND: Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event     affecting about 350 people a year in Australia. Globally it has been shown that patients with     involved groin LN, without proven pelvic LN disease on imaging receive 1 of 3 management     strategies in equal proportions - inguinal lymphadenectomy (IL); ilio-inguinal     lymphadenectomy (I-IL); or variable use of either depending on circumstances. Different     experts have strong and polarised opinions favouring either IL or more extensive I-IL with     existing cases series reporting conflicting data on best cancer outcomes. No high level     evidence proves which operation is best. HYPOTHESIS: There will be no significant difference     in DFS between patients having IL or I-IL, conditional on PET/CT scan showing no evidence of     pelvic disease at the time of diagnosis of groin LN metastatic melanoma. AIMS: To provide a     rational evidence base for management for melanoma to the groin LNs by randomly assessing the     effect of each operation on DFS, distant DFS, overall survival (OS), morbidity - including     early complications and longer-term rates of lymphedema as well as comprehensively assessed     QOL. Also to clarify the reliability of PET/CT scans for staging pelvic LNs and evaluate any     health economic benefits of I-IL over IL. TARGET POPULATION: To recruit 634 patients in 5     years. DESIGN: An Australian led, international, multi-centre, non-inferiority, phase III,     prospective, randomised clinical trial comparing IL or I-IL for patients with metastatic     melanoma to groin LNs and no evidence of pelvic disease on PET/CT. ENDPOINTS: DFS, Distant     DFS, OS and QOL at 5 years. Accuracy of PET/CT for pelvic LN metastases.      OUTCOMES: International standardization of care, improved cancer outcomes, improved QOL for     patients with groin metastatic melanoma. Proof of principle about extent of surgery when     PET/CT is clear in adjacent LN areas, leading to clinical trials investigating management of     other lymph node fields.   "
85510|NCT02166775|"     In this trial, the correlation between the psychopathological profile and sagittal balance     unexplored to date spine will be studied. Indeed, a number of patients who benefited from     well-conducted surgical treatment, targeted and tailored to their pathology, respond poorly     to it. The investigators wonder if there are biomechanical factors or factors of     psychopathological order which might influence the effectiveness of treatment. This seems     logical for the entire medical community, but it has never been demonstrated in a clinical     trial.   "
85511|NCT02166762|"     This is a prospective clinical trial to determine the optimal QLV interval during     implantation to achieve the best possible response from cardiac resynchronization therapy for     heart failure patients.   "
85512|NCT02166749|"     The purpose of this study was to find out subjective and objective outcomes of patients     undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years     after the operation. The hypothesis is that there are similar outcomes after both types of     operations.   "
85513|NCT02166736|"     Previous trials have demonstrated that the use of physiological assessment of stenosis     severity using fractional flow reserve (FFR) is superior to angiographic assessment in     percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical     utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption     rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost     associated with Adenosine.      Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for     functional significance. The main benefits of the method compared to FFR are that the     measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does     not experience any discomfort from the measurement and procedural time could be shortened     compared to when using FFR. This could potentially increase the adoption rate of physiologic     assessment of coronary lesions.      The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with     patients assessed by FFR.      Furthermore, the trial will be conducted as a registry based randomized clinical trial (RRCT)     which is a novel strategy to conduct clinical trials. The randomization will occur online in     the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based platform.   "
85514|NCT02166723|"     Patients with persistent irregular heartbeats also called persistent atrial fibrillation     usually have a lower probability of curing their arrhythmia with ablation with heat called     radiofrequency then those with paroxysmal atrial fibrillation, as previous studies have     shown.      The emerging ablation with freeze(cryoablation) has not been studied for persistent atrial     fibrillation but has been proven to be efficient in the paroxysmal type.      We hypothesized that persistent atrial fibrillation will have a freedom of recurrence rate of     70% after use of cryoablation at one year of follow up.   "
85544|NCT02166320|"     Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal     cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The     duration of this effect is however questionable. The design of SEMS can be of importance     since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis     has therefore been formulated that a partially covered SEMS is associated with less tendency     to dislocate as compared to those SEMS, recently developed, which are covered through their     entire length.   "
85555|NCT02166164|"     In this prospective trial we aim to investigate the intra-individual and inter-individual     variance in secondary hyperalgesia following pain elicited by the experimental pain model:     Brief Thermal Sensitization.      Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing     Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary     hyperalgesia.   "
85515|NCT02166710|"     Total knee arthroplasty (TKA) is a frequent and effective surgery for knee osteoarthritis.     This major surgery is associated with a reduction in knee extensor muscle strength persisting     several weeks after surgery. This decrease in strength correlates with poor functional     recovery. Its cause is multifactorial, including a deficit of the quadriceps activation, an     acute postoperative atrophy of the muscle and an important limitation related to     postoperative pain.      Peripheral nerve blocks using local anesthetics are frequently used for postoperative     analgesia following TKA. Femoral nerve blockade reduces pain and opioid consumption and     allows early passive mobilization after surgery. This block also facilitates functional     recovery and allows early discharge from the hospital. However, blocks involving the proximal     femoral nerve contribute to quadriceps weakness for the duration of nerve blockade.     Quadriceps weakness, in turn, results in functional impairment and increases recovery time. A     possible long-term quadriceps weakness associated with the femoral nerve block has even been     suggested in a recently published abstract. Hence, there is a need for an alternative     technique that could minimize postoperative pain as well as the femoral nerve block without     causing weakness of the quadriceps muscle.      Femoral nerve block performed at the level of the adductor canal seems to be a promising     alternative to the classic inguinal approach of the femoral nerve block. Studies comparing     femoral nerve block performed at the canal adductor level to the inguinal approach reported a     similar quality of analgesia, a reduction in motor block and a better functional recovery in     the early postoperative period in the canal adductor block group. The long-term effect of     femoral nerve block performed at the level of the adductor canal on knee extensor strength     after surgery remains to be studied.      This study will assess knee extensor muscle strength (principally quadriceps muscle) at 24h,     48h and 6 weeks following TKA in patients having a femoral nerve block at the adductor canal     level compared to a simulated block.      Hypothesis: The adductor canal block will allow superior recovery of knee extensor muscle     strength when compared to a simulated block at 6 weeks after total knee arthroplasty.   "
85521|NCT02166632|"     The purpose of this study is to determine quantitative and qualitative differences in     post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who     receive administration of a newly approved, long acting local anesthetic branded as ExparelTM     (bupivacaine liposome injectable suspension) introduced by one of two different     administration methods.      Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly     into the joint capsule at the conclusion of the surgery, effectively bathing the joint in     anesthetic solution.      Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local     infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9)     standard sites at the conclusion of the surgery.   "
85522|NCT02166619|"     In this study, the investigators wondered whether bihemispheric transcranial direct current     stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper     limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the     pattern of physiological variables involved in the recovery of these patients. For this     purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric     tDCS associated with intensive and individual physical therapy session.   "
85523|NCT02166606|"     The objectives of this registry are to        1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems          involving the INGEVITY lead based on observations / events        2. Gather data on actual number of MRI scans performed in the patient cohort implanted with          an ImageReady system including information about scanned body parts.        3. Collect physician feedback on lead handling with the INGEVITY lead      in a real-life, market-released standard of care environment using devices on intended     purpose and which are authorized to bear the CE (Communauté Européenne) marking / are     approved for use in the applicable area of participating centers. No additional invasive or     other burdensome examinations are to be carried out other than the ones conducted by the     centers per their general standard of care.   "
85525|NCT02166580|"     Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is     compared with the gold standard of invasive measurements. Cardiac output is derived by the     PICCO monitor.      Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the     prediction of fluid responsiveness will be defined.   "
85526|NCT02166567|"     In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods     rely on physical properties of the spermatozoa, such as the swim-up methods and density     gradient centrifugation. It is now known that current processing of spermatozoa does not     prevent the admixture of spermatozoa with damaged genetic material. The latter have a     negative impact on the outcome of ART. The investigators developed a new method for the     processing of spermatozoa with intact genetic material based on flow cytometry and sorting     (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of     this novel method of sperm sorting on the outcome of ART.   "
85527|NCT02166554|"     The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel     was safe to use, and was effective for the prevention/reduction of adhesion formation     following gynecological surgery   "
85528|NCT02166541|"     A randomized control trial investigating Biomechanical Correction of the Spine according to     Kozyavkin (BCSK) which is a part of the treatment concept Intensive Neurophysiological     Rehabilitation System (INRS). BCSK is used with the aims to reduce muscle tone and improve     gross and fine motor function in children with Spastic Bilateral Cerebral Palsy.   "
85529|NCT02166528|"     Female pelvic floor dysfunction (FPD) is due to defects in the pelvic support structures,     degradation, damage or dysfunction. The main problem of which is pelvic organ prolapse(POP),     urinary incontinence(UI) and genital tract injury. Although it does not pose a serious threat     to life, but affect the patient's quality of life seriously in the physical, psychological,     social behavior and other aspects. With the growing aging population, the incidence rate has     gradually increased, and increasing demands for people's quality of life simultaneously, more     and more attention was raised to PFD as common chronic diseases.      In recent years, the basic research, epidemiology, prevention, diagnosis and treatment of PFD     have made great progress, especially in developing gynecological urology theory and     reconstructive pelvic surgery. But overall the basic research of PFD is lagging behind,     especially susceptibility gene localization and functional studies did not get enough     attention.   "
85556|NCT02166151|"     The study is designed to assess the efficacy and safety of monthly injections of Omalizumab     150 mg for 3 consecutive months, in patients with chronic idiopathic urticaria, unresponsive     to convetional therapy by antihistamins or oral corticosteroids.   "
85557|NCT02166138|"     The condition to be studied is post-surgical scarring following primary total knee     replacement, specifically whether fractional non-ablative laser therapy can be used to     significantly decrease the morbidity of scarring.   "
85871|NCT02162017|"     This study is an investigator-initiated and conducted, international collaborative,     regionally organised, multicentre, prospective, cluster randomised, crossover, blinded     outcome assessment study to compare the effectiveness of the lying flat (0°) head position     with the sitting up (=30°) head position, in the first 24 hours of admission to hospital for     patients with acute stroke, on the poor outcome of death or disability over the subsequent 90     days.   "
85530|NCT02166515|"     As human aging, 50% of women will be faced with the threat of cancer, especially     gynecological malignancies. Ovarian, cervical and endometrial cancer are three major     gynecological malignancies. In recent years, the incidence of cervical cancer, especially in     young women significantly increased; ovarian cancer, although the incidence of malignant     tumors in the female reproductive system ranked second, but its mortality rate already in the     first place; and the morbidity and mortality of endometrial cancer is also rising.      The key to gynecologic malignancies is how to early diagnose and treat. With the advancement     of science and technology, such as molecular biology techniques widely used in the medical     field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is     expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for     linkage analysis for gynecological malignancies possible. Therefore, the investigators intend     to find specific mutations to provide a new early screening approach for gynecological     malignancies, which in later result in early diagnosis and specific treatment for     gynecological malignant tumors.   "
85534|NCT02166463|"     This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to     see how well they work compared to combination chemotherapy alone in treating children and     young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological     substances in brentuximab vedotin may be able to carry cancer-killing substances directly to     Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride,     bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in     different ways to stop the growth of cancer cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known if combination     chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin     lymphoma.   "
85535|NCT02166450|"     The aim of this study is to evaluate the influence of presence of oral fungal infection,     which leads to denture-related stomatitis, on blood pressure, endothelial function and immune     cell phenotype in patients wearing dentures.   "
85536|NCT02166437|"     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone     turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly     divided following daily teriparatide in Japanese patients under clinical practice. The     participants are treated in the investigators hospital, who are under severe osteoporotic     condition.   "
85537|NCT02166424|"     The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty     acids for pregnant women with depressive symptoms.   "
85538|NCT02166411|"     The aim of this study is to compare operative data and early postoperative outcomes of     laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using     conventional sutures .   "
85539|NCT02166398|"     A randomized, open-label, single dose, two-way crossover clinical trial to compare the     safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single     oral administration in healthy male volunteers   "
85540|NCT02166372|"     T2DM has become a major health burden for our society. More and more data support the     relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in     the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI     over 27.5 in Asia.      The evidence reviewed above strongly points to the need for a large randomized, controlled     trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2     diabetes Mellitus. This study is expected to provide very significant findings about the     natural course of diabetes in obese diabetic patients.   "
85541|NCT02166359|"     Patients with chronic kidney disease (CKD) have a markedly higher prevalence of     cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major     cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use     of glucose as the osmotic agent in PD solutions has been associated with a variety of     metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia     and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD     patients. A study showed that patients with high triglyceride levels were more     insulin-resistant than those with normal triglyceride levels.      Insulin resistant is associated with atherogenic response represented high plasma levels of     monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high     triglyceride level may play an important role to CV outcome of PD patients. PD solution     decreasing triglyceride levels is essential in PD patients.      Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase     ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of     icodextrin, which is catabolized into maltose, considerably reduces caloric uptake.     Therefore, icodextrin may have an additional favorable effect on triglyceride level.      There are several studies regarding the effect of icodextrin on triglyceride level in PD     patients. However, the outcomes are controversial, some studies showed no association between     icodextrin and triglyceride change, even the others showed positive results but these also     have study design limitations such as non-randomized study or secondary primary outcome. It     is not clear about the effect of icodextrin on triglyceride especially in PD patients without     diabetes.      The investigators therefore want to conduct a randomized, cross-over, controlled multicenter     trial comparing icodextrin solution and glucose solution in PD patients with and without     diabetes, focusing on triglyceride change.   "
85542|NCT02166346|"     Transverse myelitis (TM) is an inflammatory disorder of the spinal cord that leads to     disabilities of gait. Dalfampridine, a sustained-release potassium inhibitor has been shown     to be effective in improving gait and other neurologic functions in multiple sclerosis.     Dalfampridine has the potential to improve neurologic function in patients with transverse     myelitis as this rare disorder shares a similar pathogenic process with multiple sclerosis.     The in a clinical trial to test the efficacy of dalfampridine in TM.      The clinical trial that the investigators propose to conduct will focus on TM and will     evaluate the dalfampridine in primary neurologic outcome, 25-foot timed walk, and several     secondary outcomes including valid behavioral and neurophysiological tests.      This is a re-launch of the previous trial, which now includes additional behavioral and     clinical testing.   "
85543|NCT02166333|"     Vitamin D supplements might substantially reduce the risk of falls, potentially by more than     25%. The proposed study is a clinical trial that will determine the effects of 4 doses of     vitamin D (200 International Units [IU]/day, 1000 IU/day, 2000 IU/d and 4000 IU/d) as a means     to prevent falls in high-risk adults, ages 70 and older. Results of this trial will be     directly relevant to public health and clinical guidelines, and will immediately influence     policy.   "
85886|NCT02161822|"     Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a     favorable safety profile. In our recent in vitro study, the addition of simvastatin to     chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer     cells (unpublished data). So we planned this study to investigate the synergistic effect of     simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer     patients.   "
85545|NCT02166307|"     Aging in human physically refers to a multidimensional process that all the changes were     accumulated in a person over time. These aging changes are responsible for the progressive     increases in the chance of disease and death associated with them. So far, there are several     theories have been developed to understand the aging process, such as cross-linking, which is     led by Maillard Reactions. Maillard Reaction is a complex series of reactions between     reducing sugar/aldehydes and amino groups on proteins. Under physiological conditions,     aldehydes are products of various exogenous and endogenous amines catalyzed by     semicarbazide-sensitive amine oxidase (SSAO), a family of heterogeneous enzyme. It was     reported that SSAO shows a significant higher catalytic activity, producing more aldehydes in     age-related diseases. However, SSAO is not a perfect candidate to be monitored for evaluating     aging, because it is widely distributed in tissues, which are not readily accessible     sample-sources for clinical applications. In this work, the investigators have found 6     biomarker candidates by developing a standard-free, label-free MS-based proteomics method     based on standard protein (human serum albumin, the highest abundance protein in human     plasma) model in vitro. Then, the investigators wanted to verify these biomarker candidates     by clinical plasma samples to see if there is significant quantitative difference among     people with different ages.   "
85546|NCT02166294|"     In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K     will be evaluated in patients suffering from non-healing diabetic foot ulcers. NEOX® CORD 1K     is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for use     as a wound covering for dermal ulcers and defects. It is designated as a Human Cell & Tissue     Product (HCT/P) by the U.S. FDA.   "
85547|NCT02166281|"     Insomnia is common in Breast cancer patients during adjuvant therapy with aromatase     inhibitor.      However it is difficult to establish whether it is due to the knowledge of the disease or the     treatment administred.      The investigators designed a cohort study in which questionnaires for the assessment of sleep     quality (Pittsburgh Sleep Quality Index and Insomnia Severity Index), anxiety (State and     Trait Anxiety Inventory), depression (Beck Depression Inventory), for the quality of life in     general (Functional Assessment of Cancer Therapy) and for the evaluation of RLS (Restless     Legs Syndrome Rating Scale) will be prospectively administered to patients with early breast     cancer at baseline and during adjuvant treatment with aromatase inhibitors.      As secondary aims the investigators will also evaluate dietary and lifes' factors, born turn     over and BMI.   "
85548|NCT02166268|"     The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of     rhinitis in an environmental challenge chamber.   "
85549|NCT02166255|"     This phase I trial studies the side effects and best dose of small interfering ribonucleic     acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401) in treating     patients with melanoma, kidney, or pancreatic cancer, or other solid tumors that have spread     to other parts of the body or that cannot be removed by surgery. There are factors in immune     cells in the blood that inhibit their ability to kill cancers. Treating white blood cells     with one of these factors in the laboratory may help the white blood cells kill more cancer     cells when they are put back in the body.   "
85550|NCT02166242|"     Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed     that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell     growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200     mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately     50% non-small cell lung cancers harbored high thioredoxin reductase expression(IHC result ++     or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg     ethaselen per day was safety and tolerated by Chinese malignant tumor patients.In     pre-clinical research, our group found that, elevated of thioredoxin reductase activity was     associated with the expression of thioredoxin reductase tested by immunohistochemistry, which     means high expression of this enzyme may be a favourite predicted factor of ethaselen, the     specific inhibitor of thioredoxin reductase.   "
85551|NCT02166229|"     To investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve     the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital     ulcers, and joint contractures.   "
85552|NCT02166216|"     Competitions such as marathon running and endurance cycling events are increasingly popular     and represent an important motivation for sustaining training among leisure-time athletes.     However, there is a concern that prolonged, high-intensity exercise may increase the risk of     cardiovascular (CV) events. Following prolonged high-intensity exercise there is an increase     in levels of circulating markers of myocardial damage such as Troponin I (TnI). The precise     cause and clinical significance of this TnI increase is unknown.        -  The primary objective of this study was to determine the relationship between          high-sensitive cardiac troponin I (hs-cTnI) levels and coronary artery disease and          cardiovascular outcomes in 1000 presumably healthy leisure sport athletes that          participated in a 91 km long, high intensity endurance cycling competition.        -  The secondary objective was to assess the relationship between other CV risk factors,          fitness level and outcomes following high intensity endurance cycling competition in the          same population.   "
85553|NCT02166190|"     Malignant obstructive jaundice is a common complication of advanced stage pancreatic     adenocarcinoma and cholangiocarcinoma. Over 50% of common bile duct (CBD) obstructions are     due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis.     Biliary drainage with placement of self-expanding metal stents (SEMSs) for palliation is the     therapy of choice in this set of patients. Conventional stent placement provides palliation     for a limited duration only and these subjects come back with obstructive jaundice. Due to     age, comorbidities, malignant disease status, it is better to conduct reduced number of     therapeutic endoscopies to reduce the number of complications. Additionally, only biliary     stenting itself may provide only palliation, and not increase the duration of survival.      Currently, there are only two therapies. Recently, photodynamic therapy (PDT) has been     evaluated as a palliative and potential neoadjuvant modality. Therefore if RFA confers     similar benefits, then it may potentially be used as an alternative to PDT, given the lower     adverse event profile. More recently, RFA has been recognized for its potential in palliative     treatment of malignant biliary strictures. Based on the published data, RFA provides     palliation and seems to increase survival duration in pancreatic cancer. Our own limited     experience shows the same. The goal of this randomized controlled trial is to definitely     confirm the benefit of Radiofrequency ablation (RFA) in providing increased survival time and     quality of life in patients with non-resectable cholangiocarcinoma and pancreatic cancer.     These benefits will improve clinical practice by making RFA the new standard of care for     unresectable cholangiocarcinoma (CCA) and pancreatic cancer (PC). It will also enhance     scientific knowledge by opening the door for new opportunities, e.g. RFA as a potential use     for neoadjuvant therapy or as a downstaging agent for surgically resectable patients.   "
85558|NCT02166125|"     The purpose of this prospective registry is to assess long term data on efficacy, safety and     clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within     the Gastrointestinal tract for various GI tract disorders. The registry will evaluate     technical feasibility, clinical outcome, safety profile and overall clinical management     through medical chart review. The procedures the investigators are evaluating are all     clinically indicated and will not be prescribed to someone to participate in this research     study.   "
85559|NCT02166112|"     Incisional hernia is the most frequently seen long term complication in surgery causing much     morbidity and even mortality in patients. Despite studies on the optimal closing technique     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %.     It has been established that implementing a mesh reduces recurrence of the incisional hernia     but still the results of repair are often disappointing. Incisional hernias can become     increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy,     fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair     the incisional hernia by means of a synthetic mesh and other augmentation tools need to be     implemented.      In the recent years the use of biological meshes has been gaining popularity. Recent reports     of the use of collagen-based prosthesis have suggested that they support new vessel growth,     do not excite a significant foreign body reaction, form fewer adhesions, are well     incorporated into host tissues with minimal wound contraction, and can be used in grossly     contaminated wounds with fewer infective complications. Biologic meshes are harvested from a     source tissue and processed for medical use but they vary widely in their processing methods.     They include tissues of human or animal origins, both chemically cross-linked and non     cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current     studies investigating the effectiveness of these meshes are small and have short periods of     follow-up. These shortcomings can be explained to high cost of the meshes and unclear     indication when to use a biological mesh.      The aim of this study is investigate the short and long term effects of the Permacol©     biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what     is the true indication to use a biological mesh.   "
85560|NCT02166099|"     The purpose of this registry is to record information and evaluate the impact of SpyGlassTM     Direct Visualization System for choledochoscopy on the management of pancreatico-biliary     disorders. The registry will evaluate diagnostic performance and overall clinical management     impacted by SpyGlass.      This multi-center registry has been initiated:        -  To document the impact of SpyGlass Choledochoscopy in pancreatico-biliary disorders on          the clinical management of pancreatico-biliary disorders including malignancies.        -  To assess the sensitivity, specificity, accuracy, technical feasibility, safety and cost          effectiveness of SpyGlass and compare it to other diagnostic modalities.   "
85561|NCT02166086|"     The purpose of this registry is to record information and evaluate the impact of advanced     imaging techniques on the management of pancreatico-biliary disorders. The registry will     evaluate diagnostic performance and overall clinical management impacted by advanced imaging     techniques.   "
85562|NCT02166060|"     The purpose of this study is to determine the role of ivabradine in cardiac resynchronization     recipients with an unsatisfactory percentage biventricular pacing.      The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV     treated with optimal medical therapy as clinically indicated who received CRT-D device more     than 3 months ago. Patients with biventricular pacing <95% will and heart rate <70 at rest     and >50% of heart rate in device memory >70 will receive ivabradine. The minimal follow-up of     patients in the study will be at least six months.   "
85563|NCT02166047|"     This study will evaluate the safety, tolerability, and efficacy of GS-9620 in virologically     suppressed adults with chronic hepatitis B virus (HBV) infection who are currently being     treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts.     Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of     the doses of GS-9620 (1, 2, or 4 mg) and all participants will continue on their current oral     antiviral treatment for the entire duration of the study. Cohorts A, B, and C will consist of     a different treatment period of 4, 8, or 12 weeks, respectively, and will be followed to Week     48. After Cohort A completes treatment, a safety review will be conducted by an external data     monitoring committee prior to beginning Cohort B. Another safety review will be conducted     after Cohort B completes treatment prior to beginning Cohort C.   "
85564|NCT02166034|"     The purpose of this study is to determine whether school gardens influence children's dietary     intake, nutritional knowledge, and other outcomes.   "
85565|NCT02166021|"     The purpose of this study is to to evaluate the optimal dosage and the way of administration     of autologous mesenchymal bone marrow stem cells (MSC) either in maximal proximity of the     lesions in the CNS or by intrathecal injection to the CSF.   "
85566|NCT02166008|"     -  Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in          patients taking dual antiplatelet agents        -  Study Design: Single center, double-blind, randomized-control trial study        -  Study drug: Repamipide vs. placebo        -  Assessment criteria The patients will be discharged from the study when one of the          followings occurred,             1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up             2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy             3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy             4. Evidence of recurrent myocardial infarction from stent thrombosis   "
85567|NCT02165995|"     The goal of this clinical research study is to learn about using Navigated Transcranial     Magnetic Stimulation (nTMS) in patients having surgery to remove a brain tumor in areas of     the brain that control movement (motor function) and/or speech.      nTMS is a system designed to map the brain's function relating to movement and speech.   "
85568|NCT02165982|"     Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon     clinique à un échantillon de témoins issus de la population générale.      Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de     patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les     caractéristiques de l'activité physique et la dépendance à l'exercice physique en comparaison     avec des sujets issus de la population générale appariés pour l'âge et le sexe.      Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus     dépendants à l'exercice physique que des sujets de la population générale de même âge et de     même sexe.   "
85662|NCT02164760|"     In this study the safety and feasibility of an acellular dermal template (Novomaix), combined     with split thickness skin grafts, for use in patients with full thickness skin defects, is     tested. Results will be compared intra-patient with those obtained after conventional     treatment with split thickness skin grafts. We expect this treatment to be safe, and to     provide better outcome regarding scar quality.   "
85569|NCT02165969|"     The purpose of this study is to compare a subject's sense of smell before and after     endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory     process, fracture, defect, etc.) and use the information collected to validate approaches to     surgery that will minimize side effects to the sense of smell function. Data will be     collected using a smell identification test along with two questionnaires. In addition,     demographic, medical history, treatment, outcome, and follow-up information will be     collected.   "
85570|NCT02165956|"     The purpose of this study is to determine whether a new infant cereal has an effect on weight     gain and intestinal microbiota compared to a standard cereal in healthy infants .   "
85571|NCT02165943|"     This is a retrospective, two-arm study reviewing the healing of cavitary defects in patients     treated with Vitoss alone versus those treated with Vitoss with bone marrow aspirate (BMA).     There will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in     patients identified during the retrospective portion of the study. It is thought that the     inclusion of BMA will facilitate the resorption of the graft material, leading to better     long-term bone healing.   "
85572|NCT02165930|"     To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting     Conditions with 40% Ethanol Compared with Water in Healthy Volunteers   "
85573|NCT02165917|"     Endometriosis is a common disease of women in the reproductive age and is an important cause     for female infertility. Endometriosis is often associated with the development of adhesions     which further compromises the fertility of the affected women. The main purpose of this study     is to investigate the pregnancy rate one year after excision of endometriosis and application     of GnRH-analogues (Gonadotropin-releasing hormone) for 3 month. Half of the patients will     receive traditional endometriosis treatment with the excision of the endometriotic lesions     only. The other half will additionally receive a gel which can reduce adhesion formation     (Hyalobarrier®). Further study objective is the investigation in the development of different     types of endometriosis-associated pain over a period of one year. Potential study     participants are women with endometriosis-associated pain and with a desire to have children.     It will be investigated in the study if the use of Hyalobarrier® will result in a higher     pregnancy rate due to reduced adhesion development.   "
85574|NCT02165904|"     The study goes on 24 months, with recruiting, treatment and follow period for all patients.     The first day for each patient will be the first cellular administration. 3 doses will be     administrated every 3 months from first dose.      When the clinical trial finishes, it will be done a completed check of all obtained     parameters.   "
85575|NCT02165891|"     Despite the improvement in the technology available for diagnosing and treating empyema, the     management of empyema in children remains controversial.      The purpose of this study is to compare the efficacy and safety of two common technical     approach used for pleural effusion drainage in the treatment of childhood empyema.   "
85576|NCT02165878|"     KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) is a     nation-wide, ten-year longitudinal cohort study, launched in 2011. The aim of the study is to     assess the characteristics and risk factors of progression and complications of CKD of Korea.     Pediatric sub-cohort of KNOW-CKD is planned to enroll 450 children with CKD, stage I to V     (pre-dialysis).   "
85577|NCT02165865|"     The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary     research effort with the goal of restoring form and function to unilateral or bilateral upper     extremity amputees by vascularized composite allotransplantation of the hand/upper extremity     (hand transplantation). Hand transplantation includes transferring upper extremities/hands     from deceased human donors to patients with single or bilateral hand or arm amputation. The     purpose of the trial is to study functional, psychological, and immunological outcomes of     human upper extremity allotransplantation.   "
85578|NCT02165852|"     Because the ampulla of Vater is strategically located at the confluence of the pancreatic and     common bile ducts, endoscopic resection of papillary neoplasms may be technically different     from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best     method of endoscopic ablation and the optimal period for surveillance have not been     established.   "
85579|NCT02165839|"     PRIMARY OBJECTIVE(S):      The purpose of this study is to test the efficacy of brief behavioral therapy versus control     condition that accounts for time and attention (nutrition education) in the treatment of     insomnia in humans.      SECONDARY OBJECTIVE(S):      To assess the impact of different biomarkers on sleep disruption and other patient reported     outcomes   "
85580|NCT02165826|"     The purpose of this study is to evaluate discontinuation rates of roflumilast using an     up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of     500 μg one daily (OD) during the entire 12-week main period, and to evaluate if participants     who do not tolerate roflumilast 500 μg OD have a drug exposure with 250 μg roflumilast OD     similar to that observed in other participants with the 500 μg OD dose.   "
85581|NCT02165813|"     This is a multi-centre (RDH and ASH), phase IV, double-blind, randomised, placebo-controlled     trial of oral NTZ for the treatment of acute gastroenteritis requiring admission to hospital.     Four hundred children aged between three months and less than five years of age will be     enrolled. Study participation would be from the point of enrolment until 60 days after     enrolment. Enrolment will occur within 48 hours of admission to hospital. Enrolled     participants will be randomised 1:1 to Nitazoxanide (NTZ) or placebo. Other treatment and     management will be as per the standard of care described in the admitting hospital's     guidelines and will be ultimately the decision and responsibility of the named medical     consultant. Stool samples will be collected at the point of admission. Solicitation of     symptoms will be by review of routinely collected medical data recorded in the participant's     medical record, and will be supplemented by completion of study specific diary cards until     discharge. All participants will be followed up at day 7 after enrolment (by telephone if     already discharged) to ascertain symptoms occurring in the intervening period. At days 30 and     60 after enrolment a clinical record review will be conducted for all participants to     ascertain health care attendances following discharge.   "
85663|NCT02164747|"     The purpose of this study is to determine whether teleconsulting would be effective and     cost-effective by reducing the patients transportations and the use of emergency units for     nursing home residents.   "
85582|NCT02165800|"     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle     will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic     autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary     and sexual function disorder. However, 32%-44% patients still suffered from urinary and     sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).      Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of     work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the     protection of urinary and sexual function of male mid-low rectal cancer patients. The results     showed that L-PANP-TME significantly decreased incidence of urinary and sexual function     disorder. In order to further confirm our early work, we design a multiple-center randomized     controlled clinical trial to compare differences in urinary and sexual function protection     and long-term outcomes between L-PANP-TME and O-PANP-TME.   "
85583|NCT02165787|"     In the cross-sectional component of this study, our overall objective is to gather a large     pool of data from which we can generate gait profiles. These profiles will consist of a     constellation of gait (+/- electrophysiological) parameters associated with a particular     neurological diagnosis or specific lesion(s) in neuroanatomical systems. Once developed,     these profiles can be compared for differences and similarities; allowing insights into the     specificity of the effect on gait of a given diagnosis or lesion in the case of the former     and redundancy of neuroanatomical systems in that of the latter. A longitudinal component of     the study will look at the evolution of gait parameters over time in a group of patients with     spinal cord injury.   "
85584|NCT02165774|"     Prospective, randomized, placebo-controlled, double-blind multicenter trial including 4     tertiary sacral neuromodulation referral centers in Switzerland (Zürich, Bern, Nottwil,     St.Gallen). Patients with refractory neurogenic LUTD are included and randomized after     neuromodulator implantation into sacral neuromodulation ON or sacral neuromodulation OFF     (n=30) for a 2 months double-blind phase. In addition to standard neuro-urological     assessments, patients who agree will also undergo neurophysiological investigation of the     lower urinary tract, i.e. recording of current perception thresholds, sensory evoked     potentials, and electroencephalography after stimulation of the urethra and bladder.   "
85585|NCT02165761|"     To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic     vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 /     heparin antibodies (anti-PF4 / H antibodies).   "
85586|NCT02165748|"     Aim of this prospective observational study -in patients undergoing craniotomy for supra or     infratentorial surgery as elective or emergency procedure- is to test the hypothesis that     severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased incidence     of infections within the first postoperative week (pneumonia, blood stream, urinary, surgical     site/wound and cerebral infections)(NCT01923571).   "
85587|NCT02165735|"     The purpose of this study is to rigorously assess a program designed to empower patient     living with HIV, to improve their health care and health, and to reduce disparities.   "
85588|NCT02165722|"     The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit     increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV)     but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV)     vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to     national guidelines. The investigators will conduct a randomized cluster trial of this     toolkit in diverse primary care practices with electronic medical records (EMRs).   "
85589|NCT02165709|"     Women undergoing surgical sterilization will be interested in risk reducing salpingectomy,     and surgeons performing the procedure will be able to successfully complete the     salpingectomy.   "
85590|NCT02165696|"     Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because     of an imbalance between the production of fluid interstitial and transport. Lymphedema can     cause significant physical and psychological morbidity. Prevalence of lymphedema in patients     after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social     consequences of secondary lymphedema related breast cancer have been little recognized and     documented. Although, it have performed many studies related secondary lymphedema it not     found sufficient evidence in the literature to suggest the most effective treatment. There is     some evidence suggesting that compression therapy and manual lymphatic drainage can improve     lymphedema but more studies are needed. The aim of this research is to to evaluate the     clinical effect of multimodal treatment (compression bandaging and manual lymph drainage)     versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer     surgery.   "
85591|NCT02165683|"     This is a single-arm, open-label study to assess the safety and effectiveness of a single     dose of oral propranolol in reducing18F-fluorodeoxyglucose (FDG) uptake in brown adipose     tissue (BAT) in pediatric oncology patients. This study is designed to better understand if     taking a single dose of an oral medication called propranolol can reduce the chance of brown     fat showing up on a PET scan, and therefore make the scan more accurate and easy to     interpret. All humans have some degree of normal brown fat (called brown adipose tissue), and     this normal tissue can sometimes light up on a PET scan. That creates problems because it may     be wrongly interpreted by the radiologist as tumor, or it may hide true areas of tumor     underneath it. Participants will not be randomized and will receive a single dose of oral     propranolol approximately 60 minutes prior to the injection of the FDG tracer. The dose of     propranolol will be 20 mg for all participants.   "
85592|NCT02165670|"     BASIC VALIDATE is a coronary stent registry to obtain clinical follow-up information from     2000 patients treated with CE-marked stent (BioMatrix Flex™, Biosensors International) with     follow-up of endpoints via the Swedish angiography and angioplasty registry (SCAAR - part of     the national SWEDEHEART registry).   "
85593|NCT02165657|"     The overall aims for this study are to determine whether UVB excimer laser treatment of     psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema     with excimer laser treatment.      The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm     excimer laser will decrease the levels of serum inflammatory markers. The investigators     hypothesize that treatment will decrease plaque erythema and will result in minimal     hyperpigmentation.   "
85594|NCT02165644|"     Subarachnoid Hemorrhage (SAH) can occur commonly in the setting of trauma or brain aneurysm.     SAH accounts for 10% of all the strokes. Aneurysmal SAH accounts for 80 % of cases of     non-traumatic cases of SAH, 6-8% of all strokes and 22-25% of all cerebrovascular deaths.     Mortality can be 50% in the first few years of aneurysmal SAH rupture, 15% are severely     disabled post SAH and only 20-35% having a moderate to good recovery it has gained lot of     attention and pre-clinical and clinical trials of various agents have been tried to prevent     poor outcome. The United States epidemiology data reveals the fact that 1% to 5% of adults     have unruptured brain aneurysm and 30,000 people suffer from aneurysm rupture annually     translating to brain aneurysm rupture every 18 minutes.      Vasospasm is the most common SAH complication post 24 hours. It is the segmental or diffuse     narrowing of the vessels especially the large vessels. Fifty percent of those patients who     develop clinical vasospasm, progress to infarction and 15-20% will advance to disabling     stroke or die of cerebral ischemia. The present treatment modalities are insufficient to     prevent vasospasm. So, we need new treatment modalities to decrease the mortality and     morbidity in SAH patients.      The investigators hypothesize that Acetazolamide administration can prevent development of     vasospasm after aneurysmal SAH.   "
85595|NCT02165631|"     The purpose of this research study is to hypothesize that Simbrinza will achieve a decrease     in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and     nocturnal periods. The primary aim of this study will be to determine the effects of     Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to     compare these to those of timolol.   "
85596|NCT02165618|"     Polypharmacy is a common problem in elderly, leading among others to increased adverse drug     events. The aim of this pilot study was to evaluate whether a systematic medication     evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on     admission by an adjusted STOPP*-list in older patients) list could reduce inappropriate     prescribing for elderly admitted patients, admitted to non-geriatric departments.      (* = Screening Tool of Older Persons' potentially inappropriate Prescriptions)   "
85597|NCT02165605|"     This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness     and safety of HylaCareTM. The study will employ the patient as her own control, a commonly     used method for the evaluation of topical dermatologic agents. Each patient will be     randomized blindly as to whether the study serum will be applied to the medial or lateral     portion of the treated breast, using the nipple as the dividing line. The product and placebo     will also be applied to the contra-lateral breast in the same fashion, as a further control.     The study drug and placebo will be applied three (3) times daily.   "
85598|NCT02165592|"     Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region     of Murcia.        -  Describe the periarticular muscular deficit of the lower limbs, depending on the degree          of injury: acute and chronic, or subacute.        -  Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.        -  Detect the biomechanical changes of the lower limbs and their impact on gait in patients          with hemophilia.        -  Assess the factors that influence the perception of illness and quality of life of          patients with hemophilia.   "
85599|NCT02165579|"     The investigator plans a cohort study of 80 subjects admitted to hospital with a diabetic     foot infection in order to compare serial bone biopsies (the current gold standard) and     procalcitonin to diagnose and monitor the effectiveness of therapy for osteomyelitis. The     investigator will collect specimens as part of an existing trial to evaluate negative     pressure wound therapy in diabetic infected wounds. A high proportion of these patients have     osteomyelitis and will receive standard therapy including repeat bone biopsy and parenteral     antibiotics. The investigator expects repeated measurement of procalcitonin will be highly     correlated with repeated bone biopsy after antibiotic treatment has been completed to     determine if therapy has been successful or if additional antibiotic therapy is needed.   "
85600|NCT02165566|"     Insulin preparation -random assignment to regular insulin lin or lispro insulin as first     treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients     presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose     concentration ≤140 mg/dl (therapeutic blood glucose concentration drop). Further reduction in     blood glucose concentration after discontinuation of insulin infusion was recorded     (post-infusional blood glucose concentration drop). During the study period blood glucose     concentration, in whole blood, was measured every 30 minutes. At least 6 hours interval was     allowed between the 2 treatments.   "
85601|NCT02165553|"     Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a     cold or hot drink and is available in the United Kingdom (UK) markets in different forms     including tea bags. There is preliminary data that support the hypothesis that HSC extract     consumption has beneficial effect on blood vessel health and blood pressure reduction.     Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key     modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death     throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect     of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces     (HSC) compared with a matched control (water) on blood pressure and blood vessels function     will be investigated after a high - fat mixed meal. This is with a view to determining the     impacts of the extract on postprandial (after meal) blood pressure and other CVD risk     factors. Results from the PHYTOVAS study could lead to identification of more dietary     approaches that will contribute to CVD risk prevention and management.   "
85602|NCT02165540|"     The purpose of the study is to examine the impact of doula support for women undergoing a     manual vacuum aspiration (MVA) for an early pregnancy failure or undesired pregnancy.   "
85603|NCT02165527|"     The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer     software program can make accurate measurements of the length of leg bones compared to     conventional x-rays.   "
85604|NCT02165514|"     Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar     iDXA x-ray scan.   "
85845|NCT02162368|"     Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen     the patient self-position to avoid complications such as accidental extubation or loss of the     iv line. The aim of our retrospective study is to describe our experience in the laryngeal     mask use for airway management in patient submitted to spine surgery in neurosurgery   "
85605|NCT02165501|"     Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis     management are recognized. Investigators present a population-based registry with easy     feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of     the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic     shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU     discharge. The primary outcome is change in all-cause mortality from baseline to follow up at     6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected     from the primary care provider of the patient. The registry may provide valid data on quality     in sepsis care.   "
85606|NCT02165488|"     30% of ketamine users complain of abdominal discomfort. Long-term ketamine use is associated     with hepatotoxicity and pathologic changes to the biliary tract. Yet the prevalence of     gastrointestinal and hepatobiliary pathologies in ketamine users has not been well-described.     The investigators plan to recruit a large number of ketamine users based on referrals from     different Psychiatry clusters in Hong Kong and to investigate the underlying cause of     abdominal discomfort, describe the prevalence of different gastrointestinal and hepatobiliary     pathologies and describe their long-term outcome.   "
85607|NCT02165475|"     Background: Biofeedback and medical treatments have been extensively used for moderate fecal     incontinence. There is limited data comparing and combining these two treatments.      Aim: To evaluate the effect of biofeedback and medical treatments, separately and in     combination.      Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal     incontinence were included. The patients were randomized to start with either biofeedback     (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both     groups continued with a combination treatments, i.e. medical treatment was added to     biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal     physiology were evaluated at baseline, after single- and combination treatments.   "
85608|NCT02165462|"     Trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in     patients with haemophilic arthropathy Describe the differences in terms of the physical     variables (muscular strength, range of motion and proprioception) in patients with hemophilia     who have conducted a home treatment with a digital tool.      Bookmark the relationship between clinical history of joint bleeds and clinical     manifestations in standing and walking.   "
85609|NCT02165449|"     The drug Ketamine, available in medical practice since the late 1960s, is currently used for     inducing general anesthesia or sedation during medical procedures. When given slowly as an     injection into a vein, ketamine is shown to produce a very rapid effect on depression and to     improve depressive symptoms within hours to days. By studying patients who receive a ketamine     IV infusion, as an add-on treatment for depression, investigators may start to understand how     changes in the brain or in gene function relate to getting better over a very short period of     time. In this study, the investigators will enroll 30 patients currently ill with major     depression selected to receive IV ketamine therapy under medical supervision. To study     neurobiological changes relating to symptom improvement, the investigators will use advanced     brain scans to measure brain structure, chemistry and function. Blood samples will measure     changes in gene regulation and immune system response. Although some people have a rapid     antidepressant response to ketamine, others do not respond. Also, antidepressant effects     after ketamine usually wear off within days to weeks. In 20 of the 30 patients enrolled in     this trial, we will also determine if up to four doses of ketamine delivered two to three     times a week may prolong antidepressant response to ketamine therapy. To determine the     durability of ketamine treatment for depression, patients will be monitored by phone and via     electronic devices twice a week for up to five weeks and will return for a final assessment     when their symptoms return. For this trial, brain and blood sample measurements will occur     before and at three time points (6 hours and 24-hours) after a patient receives their first     ketamine infusion. Patients who do not remit after an initial dose of ketamine, will receive     up to three additional ketamine treatments. Mood will be measured 24-hours after each     subsequent ketamine infusion and brain and blood measurements be repeated at the time of     remission or after the fourth ketamine infusion if remission does not occur. Patients will     return for a final brain scan and blood sample when their depressive symptoms return or at     five weeks if they continue remission. Investigators will able to see how changes brain     measurements, gene regulation and immune response relate to improvements and relapse of     depressive symptoms with ketamine IV therapy. The ketamine infusion sessions will occur at a     special research unit (CTRC) at UCLA.   "
85610|NCT02165436|"     The purpose of this study is to evaluate the effectiveness of chewing gum on reducing     post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric     patients undergoing surgical correction of scoliosis. This study would provide minimal risk     to its study population, and has the opportunity to provide a benefit to patients undergoing     scoliosis surgery. If shown to be effective, this could lead to changes and improvement of     the post-operative course for pediatric scoliosis patients.   "
85611|NCT02165423|"     The purpose of this study is to address a gap in knowledge needed for care of children with     solid organ transplantation (SOT) and their parents by combining mHealth technology with an     individualized family centered self-management intervention (referred to as myFAMI). This     study is critical to the increased understanding of hospital to home transition and family     management at home with the potential to transform the way clinicians approach the care of     complex chronic illness children and families.   "
85612|NCT02165410|"     The purpose of this study is reproduce the individual detection results by PET with Arterial     Spin Labeling (ASL) MRI, to establish a biomarker useful in autism diagnosis.   "
85613|NCT02165397|"     The purpose of this study is to evaluate the safety and efficacy of Ibrutinib in combination     with Rituximab in subjects with Waldenström's Macroglobulinemia.   "
85614|NCT02165384|"     The purpose of this study is to determine if the Hummingbird ear tube delivery system is a     safe and effective way to put ear tubes in place.   "
85615|NCT02165371|"     It has been established that children in families affected by either intimate partner     violence or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) are at     substantially increased risk of poor parenting and child maltreatment. In the sub-Saharan     African context of high levels of HIV/AIDS and family violence, it is crucial that parents be     supported to establish positive parenting practices and reduce harsh or abusive parenting     within their families.This randomized controlled trial will be testing the Sinovuyo Caring     Families Program (n = 296), a 12-session (2.5 hour per session) parenting intervention for     primary caregivers of children between 2 and 9 years old. Participants will not be restricted     to biological parents and include primary caregivers of children between 2 and 9 years old,     who live in the same house as the child at least 4 nights per week. Participants will be     recruited through systematic household sampling, liaising with Western Cape Department of     Social Development and local community-based NGOs. Self-reporting questionnaires and     qualitative observational assessment data for intervention and control groups will be     collected at pre- and post-test evaluation as well as 12-month follow-up. Primary outcomes     will include child behaviour problems, harsh and inconsistent parenting and positive     parenting. Secondary outcomes will include parental depression, parental stress, parental     monitoring and supervision and parent perceived social support.   "
85616|NCT02165358|"     The purpose of this study is to investigate the paradoxical muscle enlargement in the calves     and tongue seen in patients affected by Becker muscular dystrophy and Limb-girdle muscular     dystrophy type 2I.      The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle     structure on MRI and based on a calculation of muscle strength per cross-sectional area.The     findings will be compared with results from non-affected controls.      Additionally we want to describe the tongue muscle appearance on T1-weighted MRI.   "
85617|NCT02165345|"     This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118     [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC)     tocilizumab treatment in participants with polyarticular-course and systemic juvenile     idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to     receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis     subtype and body weight. Participants will receive the treatment until commercial     availability of the drug or for a maximum of 3 years, whichever is earlier.   "
85618|NCT02165332|"     This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of     RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy     volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind,     placebo-controlled study to determine the safety tolerability and pharmacokinetics of a     supratherapeutic dose to be used in Part 2. Participants will be randomized in up to 8     cohorts to receive a single dose of either RO7033877 or placebo. Part 2 will be a single     dose, randomized, double-blind, double dummy, placebo-controlled, positive control, 4-way     crossover study. Part 2 will evaluate whether a single therapeutic or supratherapeutic dose     of RO7033877 has a threshold pharmacologic effect on cardiac repolarization, as detected by     changes in the QT/QTc interval measured by electrocardiogram (ECG). Pharmacokinetic     parameters will be assessed for Parts 1 and 2, continuous ECG recordings will be evaluated in     Part 2.   "
85619|NCT02165319|"     To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped     cuff   "
85620|NCT02165306|"     More than half of patients with epilepsy achieve full control of their seizures with     antiepileptic drugs (AEDs).The study is aimed to investigate effectiveness of an educational     intervention in improving medication adherence in patients with epilepsy.   "
85621|NCT02165293|"     This single-center, open-label study will investigate RO7033877 concentrations in plasma and     in various lung compartments, including epithelial lining fluid (ELF), and alveolar     macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration.     Bronchoscopy will be performed after the start of the last infusion on Day 3 at different     timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine     RO7033877 concentrations. The anticipated time on study treatment is 3 days.   "
85622|NCT02165280|"     We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery,     have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after     surgery compared to women who undergo our routine pre-operative care.   "
85623|NCT02165267|"     Antibodies are natural proteins that the body makes to fight infections. Antibodies can also     be manufactured like a drug and infused or injected into the body to prevent or treat a     disease. The purpose of this study is to test the safety of and the body's response to an     antibody against HIV in healthy, HIV-uninfected adults.   "
85624|NCT02165254|"     The purpose of this study is to develop a tai-chi based exercise program designed for     patients who recently had a heart attack and do not wish, or are unable, to attend     traditional cardiac rehabilitation.   "
85625|NCT02165241|"     It is commonly known that heart failure (HF) is the main cause of mortality and morbidity     which affects about 15 million people in the world and is the primary chronic cause of death.     In spite of the development of pharmacological therapies which have led to a good control of     the pathology, almost 50% of patients with advanced HF does not survive after the first year.     Heart failure consists of a deterioration of the cardiac pump, whose performance become     insufficient to satisfy the organism needs. HF can be the consequence of various pathologies,     such as ischemia, chronic hypertension, valvulopathies, pericarditis, etc. In conditions of     chronic overload, as the one induced by the cited pathologies, the cardiomyocytes reply with     hypertrophy and/or death due to necrosis or apoptosis. At the same time, there is a collagen     alteration which causes the substitution of the myocardial damaged portion with fibrotic     material, increasing in this way cardiac rigidity and reducing contractility. Finally, the     onset of inflammation, the activation of the immune system and of the inflammatory mediators     affect heart functionality. These phenomena are regulated by a complex interaction between     the cellular and molecular mechanisms, which moreover guarantee the homeostasis maintenance     in physiological conditions. Nevertheless, their imbalance activates a complex series of     events which have recently started to be recognized and studied. In effect, a recent work has     underlined the importance of the splenic monocytes in the cardiac response to acute heart     ischemia, changing our vision concerning the role of the immune system in heart     diseases.Historically, the term cardiac remodeling had been introduced to describe the     anatomical change of the heart which occurs after myocardial infarction. At a later stage, it     has been acknowledged that also other pathological conditions, such as chronic hypertension,     can be a cause of the myocardial remodeling. Physiologically, the immune system cells have     always been considered for their role of protection from infections. Recently, instead,     evidence have been showing that immune system cells might have far more complex functions in     the heart. The myocardial remodeling comes from modifications that may be adaptive to the     initial insult, but then this structural adjustment may become the activation of     structural/metabolic circles which can potentially culminate in the transition to HF.      This observational study will evaluate the immunological profile in relation to cardiac     geometry variations in hypertensive patients. Aim of this project is to characterize the     profile of immune system activation during the process of cardiac remodeling which is typical     of the cardiomyopathy of overload. The main goal will be reached through the characterization     of the circulating profile of immune system cells, in order to find a correlation with the     clinical phenotype.   "
85647|NCT02164955|"     This registry is a prospective, multi-center, observational study and will collect safety     data on multiple myeloma adult patients who have received at least two prior therapies and     take IMNOVID (pomalidomide) as part of standard care.      The registry will remain open until 500 patients will have received at least 3 cycles of     pomalidomide. All patients registered will be followed up prospectively for up to 3 years     following the end of pomalidomide treatment. During this time the incidence of second primary     malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.   "
85648|NCT02164942|"     This is a prospective, single arm, observational study examining aurora kinases and     circulating tumor cells in subjects with bladder cancer being treated with standard     cisplatin-based chemotherapy.   "
85818|NCT02162719|"     This multicenter, randomized, double-blind study will estimate the efficacy, safety and     tolerability of ipatasertib combined with paclitaxel compared with placebo combined with     paclitaxel in participants with inoperable locally advanced or metastatic triple-negative     breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and     in participants with phosphatase and tensin homolog (PTEN)-low tumors.   "
85626|NCT02165228|"     The long-term goal of the proposed research is to identify and develop effective     interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a     substantial contributor to inflammation, and interactions among stress, inflammation, body     mass index, and health behaviors have been measured. Mindfulness-based stress reduction     (MBSR) is effective for stress reduction, has been shown to be effective for inflammation     reduction in individuals with disease, and is a sustainable practice for individuals across     the health spectrum. Diet strategies are an effective means of reducing inflammation for some     individuals, but may not be successful for many people, as evidenced by the steady rise in     obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR     compared to an established intervention of a nutrition enhancement (NE) intervention for the     reduction of inflammation, and 2) test the effectiveness of MBSR compared to a     non-intervention control conditions (CON) for the reduction of inflammation. Men and women     25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or     CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory     cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles,     anthropometrics, dietary intake, and all components of the metabolic syndrome will be     measured pre- and post-intervention to elucidate underlying mechanisms and to determine     whether health benefits beyond inflammation reduction occur.   "
85627|NCT02165215|"     This Phase III, randomized, double blind, parallel grouped, placebo-controlled, multicenter     study will investigate the efficacy and safety of etrolizumab in maintenance of remission in     participants with moderately to severely active ulcerative colitis (UC) who are naïve to TNF     inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid     treatment.   "
85628|NCT02165202|"     This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the     safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight     weeks over a 40 week period among sexually active, HIV- uninfected women.   "
85629|NCT02165189|"     The purpose of this study is to evaluate sustained virologic response 12 weeks after the end     of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without     ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic     liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus     (HCV) Genotype 1 infection.   "
85630|NCT02165176|"     Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of     orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of     oral cannabis dose effects on these parameters is required to determine the level and     duration of biological cannabinoid exposure and associated subjective, cardiovascular and     cognitive effects. The present study will evaluate the detection of cannabinoids in oral     fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg,     25mg, or 50mg THC). In addition, we will conduct subjective, behavioral, and cognitive     performance assessments to evaluate the time course of the consequences of oral cannabis     ingestion among study participants. The outcomes of the study will extend scientific     knowledge about the behavioral pharmacology and toxicology of oral cannabis and can inform     policies regarding clinical, workplace and roadside drug testing programs.   "
85631|NCT02165163|"     The aim of the present study is to evaluate an innovative virtual reality-based balance     training intervention for improving clinically relevant motor performances (balance and gait)     in cancer patients.      The investigators hypothesize that the virtual reality-based balance training intervention     will improve balance and gait performances in cancer patients compared to a control group     receiving usual care only.   "
85632|NCT02165150|"     The goals of this research project are: 1) to develop and evaluate the safety and feasibility     of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care     facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness     and sleep quality of elderly residents in long term care facilities, and 3) to investigate     the compliance of elderly residents with long-term SEB exercises.   "
85633|NCT02165137|"     Quality control and improvement project: Assessment and analysis of processes and outcome in     trauma emergency room and major trauma patients at the Aarau trauma center (cantonal     hospital) with regard to initial emergency management, hospital processes and short- and     long-term (1-and 2-year) outcome of patients (subjective and objective). Comparison of     processes and outcome pre- and post- project initiative. Benchmarking with the literature and     by participation in the German and Swiss Trauma registry each.   "
85634|NCT02165124|"     The purpose of this study is evaluate the safety and effectiveness of bariatric embolization     as a minimally-invasive image-guided procedure for morbid obesity. In this procedure,     specific blood vessels to the stomach are blocked in order to suppress some of the body's     signals for feeling hungry, leading to weight loss.      Morbid obesity is currently treated with diet and exercise, medications, and surgery. This     study is designed to help treat obesity using a minimally invasive, non-surgical,     angiographic (through the blood vessel) approach. This procedure is similar to a common     procedure used to treat bleeding within the stomach. This version of the procedure has been     named bariatric embolization.      Although there are over 40 hormones that limit food intake, there is only one hormone,     ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating     fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and     to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has     been a target for the treatment of obesity and weight loss. More recently, ghrelin has been     shown to have a significant role in the long-term effect of weight loss in bariatric     (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated     patients.      Recent data collected in animals in has shown that blocking blood vessels to a particular     portion of the stomach (bariatric embolization) can temporarily decrease levels of the     appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5     people, there was a decrease in ghrelin levels and weight loss in the first month after the     procedure, but there is no information about the effects of the procedure over longer periods     of time.      We hope to learn if bariatric embolization results in safe and effective weight loss in     people who are morbidly obese.   "
85649|NCT02164929|"     The purpose of this study is to assess the effectiveness of transversus abdominal plane (TAP)     block, thoracic epidural or paravertebral block (PVB) for controlling postoperative pain when     compared with opioid you self-administer in your vein using a PCA device. The primary outcome     will be postoperative opioid consumption within 24 hours after surgery. A total of 120     subjects will be randomized in a 1:1:1:1 ratio to receive a TAP block, PVB, TEA or no block     (PCA alone).Patients in all groups will be cared for using an established enhanced recovery     after surgery (ERAS) pathway incorporating a multimodal analgesic regimen using IV     acetaminophen and postoperative PCA fentanyl.   "
85819|NCT02162706|"     Cortisol is a hormone critical for survival in times of stress. Currently most measurements     are done with blood samples. The hypothesis of this study is cortisol measured from saliva     using mass spectrometry can be used to replace measurements by blood.   "
85635|NCT02165111|"     This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of     Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's     syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in     one randomly-selected hand, and the contralateral hand will be injected with sterile saline     (placebo) to serve as a control.      Study participants at the first study visit will complete study questionnaires, their hands     will be assessed clinically for digital ulceration, and their hands will undergo non-invasive     laser Doppler imaging to assess blood flow. After this initial assessment, the patients will     undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline     solution (placebo) in the other, in a randomized, blinded manner.      Patient will report the severity of their Raynaud's symptoms weekly over the four month study     period. At one month post-injection, the patient will complete study questionnaires, their     hands will be assessed clinically for digital ulceration, and their hands will undergo     non-invasive laser Doppler imaging. At four months post-injection, the patient will again     complete study questionnaires, their hands will be assessed clinically for digital     ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition,     patient will be given the option of one week post-injection visit, at which point the same     assessment will be performed.      At the conclusion of the study, unblinding will occur.   "
85636|NCT02165098|"     The investigators are doing this study to compare blood levels and side effects of     cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate     release' capsule. The investigators will also find out if food affects the absorption of     cariprazine into the bloodstream after a 'slow release' tablet.   "
85637|NCT02165085|"     The purpose of this study is to determine whether patients with vascular Ehlers-Danlos     syndrome present significant and specific changes of arterial endothelial and smooth muscular     cell signalling/secretion, in comparison to matched healthy volunteers and patients with     spontaneous arterial dissections.   "
85638|NCT02165072|"     This is an observational study that will examine the possibility of determining the type of     Acute Kidney Injury (AKI) using bedside ultrasound machines.   "
85639|NCT02165059|"     In this research study, biopsy samples will be collected to provide more insight into the     underlying cause of the motility disorders, help direct further investigation into the cause     of the underlying condition, provide future prognosis and predict response to gastric     electrical stimulation (GES).   "
85640|NCT02165046|"     Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and     procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway     inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly     Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is     used as a bronchodilator in the management of reversible airways obstructive pulmonary     disease. Budesonide and Procaterol therefore have complementary effects, treating two     different components of asthma.   "
85641|NCT02165033|"     Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and     procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway     inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly     Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is     used as a bronchodilator in the management of reversible airways obstructive pulmonary     disease. Budesonide and Procaterol therefore have complementary effects, treating two     different components of asthma.   "
85642|NCT02165020|"     The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2     after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy     with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.     Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico     classification are included in the present protocol. The main characteristics of the study     are that the patients benefit of a reduction of the treatment duration from 40 to 20     fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of     hyaluronic acid in the perirectal fat between the rectum and the prostate.   "
85643|NCT02165007|"     The study is designed as a Pilot trial of reduced intensity Haploidentical HSCT in patients     with sickle cell disease and thalassemia. The purpose of the study is to assess the safety     and toxicity of reduced intensity conditioning haploidentical hematopoietic stem cell     transplantation.   "
85644|NCT02164994|"     This clinical study is an open, controlled, prospective, single center, single-surgeon,     post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of     the femtolaser-assisted astigmatic keratotomy.   "
85645|NCT02164981|"     The primary objective of this study is to investigate whether a single infusion of     intravenous sodium nitroprusside (0.5 μg/kg/min for 4 hours) is superior to placebo (5%     dextrose solution) at in treating positive and negative symptoms of schizophrenia   "
85646|NCT02164968|"     INTRODUCTION      Lung function assessment of preschool children is hindered by their limited co-operation in     conventional tests such as peak expiratory flow (PEF) or spirometry and the methods available     for younger children are, again, laborious and time consuming. However, impedance     pneumography (IP) records indices of airway obstruction during normal sleep at home and has     been shown accurate in wheezy preschool children (Seppä et al. J Appl Physiol 2013).      AIM OF THE STUDY      The general purpose of this study is to assess the clinical value of the information provided     by overnight home recording of tidal breathing by means of IP technique in young children     with asthmatic symptoms and inhaled corticosteroid (ICS) medication.      The main hypothesis is that IP measurement can distinguish between groups whose asthmatic     symptoms recur or do not recur after ending the ICS drug treatment period.      METHODS      The study recruits 1-5 year old children (n=75) who have presented at the emergency room due     to obstructive bronchitis and for whom an ICS drug treatment period has been prescribed based     on the national guidelines.      The subjects will perform three overnight IP measurements at home at two weeks intervals     close to and after ending of the treatment period.      SIGNIFICANCE OF THE STUDY      Being an affordable, simple and convenient ambulatory measurement method, IP may bring needed     objectivity to asthma diagnostics and asthma drug response assessment in young children.   "
85650|NCT02164916|"     This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with     or without vemurafenib works in treating patients with colorectal cancer that has spread to     nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be     removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known     whether irinotecan hydrochloride and cetuximab are more effective with or without vemurafenib     in treating colorectal cancer.   "
85651|NCT02164903|"     The broad goal of this study is to investigate if differences exist (and in which areas and     of what magnitude) in QoL and symptoms of patients with CML being treated with first line     therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an     additional objective is to characterize medication-taking behavior associated with imatinib     or dasatinib.   "
85652|NCT02164890|"     Invasive fungal infections (IFIs) are a frequent cause of morbidity and mortality in     high-risk patients, such as immunocompromised patients. Candida is currently the predominant     fungal pathogen in these patient populations and is associated with significant morbidity and     a high mortality.      Micafungin (MCF) is a semisynthetic compound belonging to the new class of antifungal agents,     the echinocandin lipopeptides, that has potent in vitro and experimental in vivo activity     against a variety of pathogenic Candida species and Aspergillus species. Its applied     indications are so the treatment and/or the prophylaxis of Candida and Aspergillus     infections. MCF is currently licensed for the treatment of candidiasis at doses of either 100     or 150 mg a day.      The efficacy of MCF is linked to the area under the concentration-time curve over 24 h in the     steady state divided by the MIC (AUC0-24/ MIC ratio).      On one hand:      - It was demonstrated that 98% of invasive candidiasis patients with a MCF AUC/MIC ratio     between 3 and 12 achieve microbiological clearance, as opposed to only 85% of those with an     AUC/MIC ratio < 3. In the case of infections by Candida parapsilosis, which exhibits drug     MICs that are 50- to100-fold higher, 100% of patients with an AUC/MIC ratio >285 achieve     microbiological clearance, as opposed to 82% of those below that exposure level.(1)      On the other hand:        -  It is well known that patients of intensive care units (ICU) are characterized by          particular pharmacokinetic parameters with higher apparent volume of distribution (VC/F)          and/or higher apparent systemic clearance (CL/F). In a population of healthy volunteers,          it was observed that CL/F of MCF presents a high interpatient variability.(2)        -  Whether most ICUs patients achieve optimal AUC/MIC ratio thresholds at standard doses          has not been investigated so far. In particular, lower AUCs might be reached in patients          having the highest VC/F values. Such patients would then be at risk of therapy failure          and would benefit from individualized-dosing strategies.      In this context, the study of the pharmacokinetics of MCF in critically ill patients seems to     be necessary.   "
85653|NCT02164877|"     The purpose of this study is to evaluate the effect of soluble dietary fiber on bacterial     translocation and mucosal immunology in patients with Crohn's disease.   "
85654|NCT02164864|"     The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of     110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE DAT) and 150mg     dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple     Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus ASA     <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI     with stenting (elective or due to an Acute Coronary Syndrome).      The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT     in terms of safety. Safety will be determined by comparing the rates of bleeding events,     assessed using the modified International Society of Thrombosis and Haemostasis     classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.   "
85655|NCT02164851|"     The goal of this study is to compare the characteristics of echocardiography and different     monitoring devices in shock patients, the relationship of device parameters to biomarkers     associated with shock, and determine if these any of these add clinical utility when     predicting the cause of shock. We will perform a prospective, observational study of patients     found to have shock physiology in the ED and follow them to determine the final shock     category and ultimate outcomes.   "
85656|NCT02164838|"     This trial will be the first study of axitinib in children and adolescents. The primary     objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or recommended     Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid tumors.     Additional objectives include measurement of pharmacokinetic and pharmacodynamic parameters,     description of the toxicity profile of this agent in children and adolescents, and assessment     of response within the confines of a Phase 1 trial. A standard rolling 6 design will be used     for dose escalation. Further development of axitinib will focus on development of a joint     cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric, adolescent and young     adult translocation renal cell carcinoma.   "
85657|NCT02164825|"     Single-shot femoral nerve block is similar to continuous epidural technique for postoperative     analgesia in total knee arthroplasty   "
85658|NCT02164812|"     The purpose of this study is to determine whether multiple doses of Efavirenz has an effect     on the QTc interval (corrected by Fridericia) in CYP2B6 *1/*6 and *6/*6 healthy subjects.   "
85659|NCT02164799|"     The Shock Tool study is designed to improve the clinical evaluation for differentiating shock     in the emergency department. The goal of this study is to evaluate and improve the accuracy     of physicians differentiating causes of shock.   "
85660|NCT02164786|"     Acute severe disease is a major public health challenge that often affects young adults.In     past decade, there are lot of new techniques have been developed that aim to improve the     outcome of acute severe disease, But few of these works success. According to recently     studies, the mortality of the multiple organ dysfunction syndrome（MODS) that is the major     cause of death in patients who suffering from acute severe disease, is not improved. On the     contrary, if MODS be predicted in early stage of acute severe disease, the death can be     prevented. Because acute severe disease poses complex injury that involves multiple     pathological processes, understanding the cellular and metabolic network malfunction during     acute severe disease is crucial for clinical monitoring and intervention.      Human metabolism is a complex network with hundreds of cross-linked paths. During critical     illness, the metabolic network is dynamically disturbed at multiple points. Classical     research typically isolates a small part of this network to investigate the impact of     pathological physiology molecular mechanisms on clinical outcome. In particular, researchers     have examined metabolic disturbances such as cytokine network dysfunction, skeletal muscle     breakdown, insulin resistance, dyslipidemia, testosterone and growth hormone/Insulin like     growth factor （IGF）dysfunctions, low thyroxine syndrome, and deficiency of vitamin D and     calcium with secondary hyperparathyroidism. These complex metabolic disturbances appear and     interact at different stages during the pathological process after acute severe illness.     Therefore, an integrated approach that combines the biochemical/molecular changes with     network disturbances is the key to understanding acute severe illness at the systems biology     level and establishing an accurate quantitative model for clinical monitoring.      An interdisciplinary method that includes high-throughput quantitative techniques and     effective mathematical and visualization tools is necessary. Furthermore, interdisciplinary     methods present the opportunity to develop innovative clinical diagnosis and monitoring     methods for severe injuries. The aim of this study is to provide a novel high-throughput     method that integrated proton-nuclear magnetic resonance (NMR) metabolomic fingerprinting and     High Performance Liquid Chromatography with advance mathematics tools to modeling metabolic     dynamics after acute severe disease.   "
85664|NCT02164734|"     In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via     nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be     randomized to standard delivery of surfactant via and endotracheal tube airway (inserted     after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via     laryngeal mask airway (LMA). The intent is to remove the airways and return babies to     non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate     of failure of initial surfactant therapy. Standardized failure criteria are reached: a)     early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal     intubation and mechanical ventilation) or, b) late, if the baby requires ventilation,     retreatment with surfactant within 8 hours or more than 2 doses of surfactant.      The objective of this protocol is to reduce the need for endotracheal intubation and     mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by     instilling surfactant though an LMA, while achieving comparable efficacy of surfactant     treatment.      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of     babies with RDS who require mechanical ventilation or subsequent intubation, when compared to     standard surfactant treatment following endotracheal intubation with sedation.   "
85665|NCT02164721|"     The purpose of this trial or study is to determine if cardiac resynchronization therapy (CRT)     can be a benefit to people who have impaired heart function due to past treatment with     chemotherapy and/or chest radiation. The investigators are looking to enroll approximately 30     eligible subjects with heart failure in this trial. All patients enrolled and registered in     the study will be implanted with a cardiac resynchronization therapy device that includes an     implantable cardiac defibrillator (CRT-D). Clinical histories, physical exams, and external     device testing will be collected both at the time of enrollment in the trial and during     follow-up study visits. Following implantation of the CRT-D, patients will be contacted by     phone at 3 months and will have a scheduled clinic visit follow-up at 6 months.   "
85666|NCT02164708|"     This paper extends prior research by exploring how students with self-critical (SC) traits     respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety     sensitivity and mood changes during the school year as students attended MM tutorials ii) to     study the relationship between self-criticism and MM-related benefits over time. This paper     reports on participants' mood and anxiety sensitivity changes before, during, and after the     MM program and the association between depressed mood and SC levels. Participants were     trained in MM over two continuous semesters, with two specific hypotheses guiding     evaluations:        1. Participants overall would report progressive improvements in psychological well-being          as measured by mood and anxiety sensitivity variables, reflecting the effectiveness of          the MM program.        2. Elevations in self-critical personality traits would predict greater improvements in          depressed mood, given the greater need to neutralize cognitive events related to          negative moods.   "
85667|NCT02164695|"     To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in     patients with ST-segment elevation myocardial infarction treated with primary percutaneous     coronary intervention (PPCI) within 12 hours of symptoms onset.        -  Control group: PPCI only        -  Study group: PPCI + RIPC      Primary endpoint: Salvage index measured by contrast-enhanced cardiac magnetic resonance     (CMR) at 3 to 5 days after index procedure   "
85668|NCT02164682|"     Hypospadias refers to a disease represented by a congenital defect in the urethra meatus     (urinary opening) in male children. Due to the postoperative pain, symptoms such as     discomfort, agitation, and restlessness are generally found. In particular, young children     with restlessness often express their pain or discomfort with their bodies because they are     unable to express it in words. This severe restlessness may make an operated region unstable,     accompanying bleeding, infection, or other surgery-related complications. Because     postoperative pain control is very important, neuraxial block techniques such as epidural     block or caudal block have been employed in addition to a penile dorsal nerve block. Although     the neuraxial block technique including the caudal block is an easy and safe method and has     an excellent effect, the neuraxial block technique poses a potential risk in the procedure.     In addition, with respect to the surgical prognosis, it has been reported that penile     engorgement may cause penile vasodilation, resulting in oozing at the surgical region or     other surgical complications. However, there has not been a report on the increase of     postoperative complications by penile vasodilation or on the difference in the recovery or     surgical prognosis according to the types of pain control for young patients.   "
85669|NCT02164669|"     Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the     underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and     biochemical indicators will be used to explore the underlying mechanisms and represent a     promising precursory target for diagnosis and treatment of POCD.   "
85670|NCT02164656|"     The Mindfulness Training for Smokers Online Feasibility Study is a pilot study designed to     test Mindfulness Training for Smokers in an Internet format with phone counseling.   "
85671|NCT02164643|"     A Multicenter national longitudinal cohort study including at least 800 individuals     consecutively recruited from French Research Memory Centers and followed-up over 24 month and     included in Memento.   "
85672|NCT02164630|"     The purpose of this study is to examine the effects of a hope-based intervention on clinical     and experimental pain in individuals with temporomandibular disorder (TMD). To examine the     effectiveness of this intervention, a two-arm randomized trial will be conducted with 50     individuals, between the ages of 18 and 65, who have TMD.   "
85673|NCT02164617|"     The goals of this three-year research project were: 1) to develop and evaluate the     feasibility of the Wheelchair-bound Senior Elastic Band (WSEB) for the demented,     wheelchair-bound seniors in long-term care facilities, 2) to evaluate the long-term effects     of the instructor-led WSEB on the functional fitness, daily life function, depression, and     problem behaviors of this senior population, and 3) to test the feasibility, compliance, and     effectiveness of the DVD-led WSEB on this senior population.   "
85882|NCT02161874|"     This study evaluates the T3 implant system for the preservation of alveolar crestal bone and     the establishment of initial integration. The new surface-treated features of the implant may     contribute to improved soft and hard tissue healing. The success rate of the T3 implant will     be no different than that of the control implant, which possess similar geometry but     different surface treatments.   "
85674|NCT02164604|"     Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born     children, characterized by the development of retinal neovascularisation, macular dragging     and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially     in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in     the development of the disease. Recently, the BEAT ROP study tested the efficacy of     intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized,     stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit     for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths     after treatment. The authors also concluded that safety could not be assessed due to the     small sample size. Other authors raised concerns regarding the results of the BEAT ROP study     and the safety of bevacizumab.      The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus     ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single     injection of ranibizumab.   "
85675|NCT02164591|"     The purpose of this study is to determine the physiologic effects of temporary gastric     electrical stimulation in subjects with severe gastroparesis.   "
85676|NCT02164578|"     Study to investigate microvascular and antiinflammatory effects of Rivaroxaban compared to     low dose aspirin in type 2 diabetic patients.      Especially patients with cardiovascular disease and subclinical inflammation are in the focus     of interest.   "
85677|NCT02164565|"     The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur     surgery.   "
85678|NCT02164552|"     The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS     will improve insulin sensitivity and resistance and inflammatory response to PCOS.   "
85679|NCT02164539|"     The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide     in combination with fluticasone furoate compared with fluticasone furoate monotherapy in     chronic obstructive pulmonary disease participants with an asthmatic component. The     fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily     inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.   "
85680|NCT02164526|"     Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging     society, chronic heart failure has become a global public health problem. Therefore the     prevalence of pulmonary hypertension due to the left heart disease is increasing. However,     there is no research on the prevalence of pulmonary hypertension due to the left heart     disease in China. Therefore, the aim of the present study was to describe real-world outcome     of Chinese patients with pulmonary hypertension due to the left heart disease and identify     factors that may predict outcome. Our study will profile the demographics, clinical course,     treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.   "
85681|NCT02164513|"     The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol     (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with     dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the     use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic     Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple     inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health     Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to     dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile     with dual or monotherapy doses for periods of up to one year. Given the clinical experience     with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from     their known pharmacology, the potential benefit of a new therapy option in patients with     moderate to severe COPD supports the further development of the closed triple combination     (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion     criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety     follow-up period. Eligible subjects will be randomized to one of the following double-blind     treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100     mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD   "
85682|NCT02164500|"     The Purpose of this trial is:        -  to determine the overall response rate (ORR, complete response [CR] + partial response          [PR]) in patients with relapsed or refractory HL        -  to determine the safety profile of ruxolitinib in patients with relapsed or refractory          HL   "
85683|NCT02164487|"     Vitamin B1 (Thiamine) is a water soluble essential nutrient; it is synthesized by a variety     of plants and microorganisms. Since animals usually cannot synthesis it, humans must be     supplied with exogenous vitamin B1 in the diet. The human storage of thiamine is small- about     30mg, an intake of 1-2 mg a day is needed to maintain this pool. Deficiency might occur when     the vitamin is depleted from the diet in a short period. Vitamin B1 has a role in energy     metabolism and main biosynthetic pathways. Low thiamine causes illnesses in the central and     peripheral nervous systems as well as affecting the heart and gastrointestinal systems.      Deficiency may occur from malnutrition of different mechanisms such as alcoholism, lack in     diet and recently secondary to anti-obesity surgery and few case reports described eating     disorders as the reason for developing deficiency causing neuropathy, (1,2) and     encephalopathy (3,4,5).      One of the presentations of thiamine deficiency is peripheral neuropathy mimicking     Guillain-Barre syndrome, and administering the lacking vitamin improves the symptoms.      One study examined the prevalence of vitamin B1 deficiency in adult anorexia nervosa patients     (6) by measurement of the activation of the enzyme erythrocyte transketolase following     addition of thiamin pyrophosphate and comparing them to control of blood donors. This study     found significant lower levels of vitamin B1 in the anorectic patient compared to the     controls.      Rational of the study:      The investigators assume that these few cases described of overt neurologic impairment due to     vitamin B1 deficiency because of distorted eating are just the tip of the iceberg and more     eating disorders patients lack thiamine, that may have neuropsychiatric effect on the illness     and identifying and treating the shortage may improve the symptoms of the disorder and maybe     even the distorted thoughts that are fundamental in eating disorders.   "
85695|NCT02164331|"     Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the     Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly     visits for hypertensive patients with uncontrolled blood pressure (BP) using a     theoretically-informed, empirically grounded, multimodal quality improvement (QI)     intervention.      Aim 2: To improve BP control and reduce disparity in BP through implementation of monthly     visits.      Aim 3: To assess potential mediators and moderators of the intervention.   "
86885|NCT02148796|"     The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk     infants for 10 days, monthly, for two consecutive years can increase time to occurrence of     the first episode of wheezing lower respiratory tract illness (WLRI) during a third     observation year after therapy   "
85684|NCT02164474|"     Exercise is a proven strategy for preventing type 2 diabetes. Traditionally individuals have     been prescribed moderate-intensity continuous aerobic exercise but adherence to this standard     exercise program is dismal. High-intensity interval training (HIIT) is a novel form of     exercise that involves brief, repeated bursts of vigorous exercise separated by periods of     recovery. HIIT elicits many favourable cardiometabolic adaptations that are similar to     traditional exercise but does so with a lower amount of exercise and in substantially less     time than moderate-intensity continuous exercise. Therefore, HIIT has been touted as a     time-efficient exercise strategy for improving health. Whether overweight individuals at     risk for pre diabetes will show greater adherence to HIIT than moderate-intensity continuous     exercise over the long-term (12-months) has not been tested. Because exercise adherence     requires complex self-regulation, interventions designed to improve adherence should include     a behavioural component. The investigators will assess adherence to HIIT and     moderate-intensity continuous exercise over 12 months following a short-term (2 week)     intervention of either HIIT or moderate-intensity continuous exercise. Both conditions will     include a self-regulatory component targeted to increase participants' confidence to engage     in regular, independent exercise. The results will help determine whether HIIT is a more     feasible option for promoting exercise adherence for pre diabetes prevention than the     traditional moderate-intensity continuous exercise. The investigators hypothesize that a)     over the 12 months follow-up subjects randomized to the HIIT will be more likely to adhere     when compared to moderate-intensity continuous exercise, b) over the 12 months follow-up     subjects randomized to HIIT will have higher rates of adherence and levels of total physical     activity, c) greater increases in self-regulation (including goal setting, self-monitoring,     and self-regulatory efficacy) following HIIT will mediate higher rates of adherence, d)     10-days of HIIT and moderate-intensity continuous exercise will improve cardiorespiratory     fitness, increase insulin sensitivity, reduce circulating inflammatory markers, and improve     glucose control and e) Improvements in cardiometabolic health factors will be greater     following HIIT compared to moderate-intensity continuous exercise.   "
85685|NCT02164461|"     To evaluate the tolerability and safety of ADXS11-001 (1 x 10^10 colony forming units [cfu])     administered with prophylactic premedication in repeating 3-dose study cycles in women with     persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or     adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS,     time to progression) by immune-related Response Evaluation Criteria in Solid Tumors     (irRECIST).   "
85686|NCT02164448|"     The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate     the hemodynamic instability and decrease in the splanchnic blood flow caused by     pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of     intraoperative dexmedetomidine infusion on postoperative bowel movement in patients     undergoing laparoscopic gastrectomy.   "
85687|NCT02164435|"     This is a prospective, single centre clinical investigation looking at short (6 months) and     long term (24 months) changes in cardiac function and renal function in patients with     drug-resistant hypertension post renal sympathetic denervation.   "
85688|NCT02164422|"     Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize     that guanfacine versus placebo will decrease the number of drinks consumed during the 2-hour     self-administration period across stress and neutral/relaxing conditions.   "
85689|NCT02164409|"     This is a research study for patients who currently have or previously had an H. pylori     infection and who plan to undergo an endoscopy as part of their care. The purpose of this     study is to find out how and why H. pylori infections can cause progression to gastric cancer     and if it's possible for intervention prior to this progression.   "
85690|NCT02164396|"     The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or     persists after the continued usage or discontinuation of contact lenses or refitting with low     coefficient of friction lenses.   "
85691|NCT02164383|"     The objective of this research is to determine whether smartphone games show promise for     helping smokers increase their chances of quitting. The central hypothesis is that smokers     who have access to smartphone games during their quit smoking attempt will smoke fewer     cigarettes and report less craving than will smokers without such access.   "
85692|NCT02164370|"     Acid/base imbalances are not well understood in pre-eclamptics, and better tools are needed     to allow a thorough and meaningful evaluation. Disorders of electrolytes and albumin are     common findings [13, 14], and the impact of such disorders on acid-base homeostasis has     increasingly been acknowledged [4, 15]. The purpose of this prospective case-control study is     to evaluate acid-base status in 100 women with mild or severe pre-eclampsia and 25 healthy     controls by applying the Stewart Fencl's physicochemical acid-base model. We hypothesize that     several simultaneous, and possibly offsetting, metabolic acid-base disorders will be     identified and quantified, and that these may be useful to guide clinicians in their medical     management and indication for delivery. Intermediate and long-term goals are to evaluate the     ability of the Stewart Fencl's physicochemical acid-base model to guide fluid management and     predict maternal and neonatal outcomes.   "
85693|NCT02164357|"     This study will compare two ways of treatment for acute ischemic stroke: an endovascular     treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a     first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT     in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours     after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed     separately.   "
85694|NCT02164344|"     Combined antiretroviral therapy (cART)-treated patients have increased mortality and     morbidity compared to age-matched seronegative individuals. This increased mortality and     morbidity has been associated to immune activation that persists also in patients under cART     even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients,     irrespective of cART treatment, show higher levels of activated T cells, inflammatory     monocytes and proinflammatory cytokines than seronegative individuals. Several putative     causes of this residual inflammation have been proposed and include ongoing HIV replication     at low levels, the presence of coinfections such as cytomegalovirus, and microbial     translocation.      None of these causes are mutually exclusive and understanding the degree to which of these     three cause residual inflammation in cART-treated individuals will require novel therapeutic     interventions aimed at alleviated each putative cause.      In this longitudinal study we aim:        1. to reduce microbial translocation induced inflammation in cART-treated individuals with          supplementation of cART with the probiotics.        2. to investigate the potential benefits of 24 weeks of probiotics supplementation on          immune function and on immune activation status      Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract     microbiome with reducted levels of bifidobacteria and lactobacillus species with increased     levels of potentially pathogenic proteobacteria species.   "
85730|NCT02163876|"     This study will evaluate the safety and efficacy of human central nervous system stem cell     transplantation into patients with traumatic injury in the cervical region of the spinal     cord.   "
85731|NCT02163863|"     Primary purpose of the Mimics Study is to evaluate the safety and performance of the     BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.   "
85696|NCT02164318|"     This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates     of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring     vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a     program of forearm exercise training, application of nitroglycerin ointment or both. Goals of     this study are (A) to measure if recruited subjects can tolerate the intervention protocols,     and determine if dependent variable measures, including surgery outcome, and measurement of     physiologic and biologic markers, can be obtained; (B) To measure subject compliance and     adherence rates for each of the intervention arms and testing visits; (C) To examine which     intervention or combination of interventions demonstrates the strongest preliminary effects     in order to estimate power for a pivotal intent to treat trial; and (D) explore group     differences in clinical vascular markers and biologic markers in vein tissue.   "
85697|NCT02164305|"     Dynamic control of the rotator cuff muscles plays an important role in stabilizing the     shoulder during motion. Impairment in the neuromuscular control of these muscles may to lead     to injury and pain. Rehabilitation programs have moderate success in decreasing pain and     improving shoulder function. While most of these programs target the rotator cuff, it is     still unknown if they serve to improve the neuromuscular control of the rotator cuff muscles.     The rehabilitation may induce neurological and physiologic changes in neuromuscular     structures and thus alter the neuromuscular control of the entire shoulder complex.     Kinematics and electromyographic (EMG) activities have been widely used to study     neuromuscular control. However, corticospinal excitability, which has been widely examined in     the patients with neurological disorders, provides a more detailed account of central control     from the primary motor cortex through the spinal cord to the muscles. This assessment of     neuromuscular control will serve to illuminate the ability of the shoulder muscles to handle     the stress from activities such as overhead sports activities and carrying or lifting heavy     objects. This approach could be used to help design efficient training program for athletes     and effective rehabilitation program for patients with shoulder injuries. The purpose of the     proposed study is to investigate the effect of exercise treatment effect on the     proprioception, kinematics, EMG and corticospinal excitability of shoulder muscles, including     the deltoid and rotator cuff muscles.   "
85698|NCT02164292|"     The possibility to achieve a curative resection in patients with liver malignancies is     limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein     ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a     revolutionary strategy to achieve resectability by inducing a rapid and large FLR     hypertrophy. However, the possibility of achieving a short-term hypertrophy and high     resectability rates has been counteracted in most published series by an increased risk of     morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS     procedure in a single high-volume HPB center, with special emphasis in the safety and     feasibility of this new 2-stage strategy. The aim of the present study was to assess the     safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.   "
85699|NCT02164279|"     About 30 to 40% of patients suffering from type I diabetes are at risk of developing a     diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease.     Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset     of DN. However, it is a late (because it permits to detect a renal disease already present),     non-specific and low sensitive biomarker.      Therefore the main objective of this study is to identify early urinary biomarkers predictive     of DN in children with type I diabetes, before the appearance of a microalbuminuria.   "
85700|NCT02164266|"     This study is designed to investigate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in healthy     volunteers (Part 1) and in Type 2 diabetes patients (T2D) (Part 2). The anticipated time on     study treatment is two weeks.   "
85701|NCT02164253|"     The FAIR-ALS study is to investigate the safety and efficacy of a scavenger treatment of iron     deferiprone, which would reduce the brain iron to limit the development of amyotrophic     lateral sclerosis.      It has been shown an excess of iron in the central nervous system carrying a sporadic ALS     patients. Iron overload associated with a loss of motor neurons may explain the signs of the     disease (atrophy).      The investigators discuss the hypothesis that reducing excess iron, the investigators can     reduce the loss of neurons and thus the progression of signs of the disease.   "
85702|NCT02164240|"     The purpose of this research study is to determine the safety and tolerability of sunitinib     alternating with regorafenib in participants with advanced gastrointestinal stromal tumor     GIST, if the standard approved therapies (imatinib, sunitinib and regorafenib) have failed to     control the disease. Additionally, this study seeks to determine the highest dose that can be     given safely for this combination of drugs.   "
85703|NCT02164227|"     The effectiveness of breathing exercise on anxiety in women during the first period of labor.   "
85704|NCT02164214|"     TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the TNF     ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on target     cell type, TWEAK triggers multiple cellular responses ranging from modulation of inflammation     to cell death when it binds to its main receptor, Fn 14. Our team has been the first to     describe pro-inflammatory effects of TWEAK during central nervous system inflammation.     Various data support the possibility that TWEAK produced by synovial macrophages may     contribute to chronic synovitis in animal models and in humans. In psoriatic arthritis     (PsoA), anti-TNF therapy has been successful concording with the key role of TNF in the     pathogenesis of this disease and the generation by psoriatic patients of neutralizing     anti-TNF autoantibodies referred as beneficial autoimmunity to pro-inflammatory mediators.     In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory     synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy.     The role of TNF-alpha in the regulation of TWEAK expression remains unclear.   "
85705|NCT02164201|"     This is a prospective, multicenter, single-arm study designed to collect clinical data to     support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic     hemostasis following cardiovascular surgery.      The overall objective of this clinical study is to collect clinical data supporting the     safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis     following cardiovascular surgery. This study is intended as a post-market surveillance     (follow-up) study.   "
85706|NCT02164188|"     This protocol proposes a well-being program based on meditation and Positive Psychology     principles such as human development, the improvement of virtues, quality of life and     well-being. The investigators hypothesize that this program may promote well-being and reduce     stress related problems in the participants. Objectives: To evaluate the efficacy of a     well-being program in a sample of managers who work in a company (Natura Inovação/Cosméticos     ) and health care professionals who work in a hospital (Hospital Israelita Albert Einstein)     as well as its implication in the work environment. Methods: Sixty managers from Natura     Inovação/Cosméticos and 60 health professionals from Hospital Israelita Albert Einstein will     be recruited. The participants will be randomized in two groups of 30 participants each one,     half of them in the control group (GC) and the other half to the intervention group (GI).   "
85707|NCT02164175|"     Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving     Hemodialysis   "
85708|NCT02164162|"     In Parkinson's disease, gait disturbances represent one of the most disabling motor symptoms,     frequently associated with an increased risk of falls, loss of independence and a negative     impact on quality of life. In recent years, the interest in automated robotic devices for     gait training for Parkinson's Disease patients has grown. With their consistent, symmetrical     lower-limb trajectories, robotic devices provide many of the proprioceptive inputs that may     increase cortical activation and improve motor function while minimizing the intervention of     a therapist. So the main aim of this study will be to analyze, through a clinical and an     instrumental evaluation, the effectiveness of a Lokomat gait training in subjects affected by     Parkinson's disease in comparison to a ground conventional gait training.   "
85709|NCT02164149|"     The quality of colon cancer surgery is highly debated these years since the mortality of the     disease is not declining markedly. Surgery is the main treatment of colon cancer and during     surgery it is very important for the surgeon to remove the tumour and all potential ways of     tumour spread. As colon cancer first of all spreads to the nearby lymph nodes lying along the     tumour feeding artery the surgeon aims to cut the vessel as central as possible. This means     that all of the tumour feeding artery should have been removed after surgery.      In this study the investigators want to measure the length of the tumour feeding artery after     surgery as a quality control of the surgery. The investigators hypothesize that the artery     will be shorter than 5 mm.      The investigators wish to CT scan all patients two days after colon cancer surgery and     afterwards measure then length of the artery on the images. This study will not inflict with     the normal routine for patient information and treatment.   "
85710|NCT02164136|"     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle     will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic     autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary     and sexual function disorder. However, 32%-44% patients still suffered from urinary and     sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).      Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of     work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the     protection of urinary and sexual function of male mid-low rectal cancer patients. The results     showed that L-PANP-TME significantly decreased incidence of urinary and sexual function     disorder. In order to further confirm our early work, we design a randomized controlled     clinical trial to compare differences in urinary and sexual function protection and long-term     outcomes between L-PANP-TME and O-PANP-TME.   "
85711|NCT02164123|"     The purpose of this study is to determine whether passive accessory intervertebral     mobilization applied to the fourth thoracic vertebra produces autonomic effects.   "
85712|NCT02164110|"     The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol     in Healthy Adults and Children.   "
85713|NCT02164097|"     This study will be with pediatric patients who have refractory/recurrent solid tumors. They     will receive standard chemotherapy (ICE) and we are investigating if the addition of a new     drug, ODSH, will help to increase the time of their platelet recovery after ICE     chemotherapy.The purpose of this study is to evaluate the safety and tolerability of ODSH in     pediatric patients receiving ICE chemotherapy.   "
85714|NCT02164084|"     This study will identify how much (if any) drug is absorbed from the skin of subjects with     acne vulgaris after topical application of SB204.   "
85715|NCT02164071|"     The elderly comprise the most prevalent population in oncology practice. The available     evidence suggests that old patients are undertreated patients, mainly because of their     advanced age, regardless of whether they are highly functional patients, they do not present     co morbidities and could benefit from oncology therapies.      Treatment planning must consider several health indices that are useful when it comes to     detecting geriatric problems that could affect the patient's treatment experience. The     complete comprehensive geriatric evaluation stands out as cornerstone among other validated     tools that do not work as isolated instruments; however, its length and complexity may hinder     its routine use in clinical practice for decision making.      The purpose of this study is to validate a comprehensive health status assessment scale in     elderly patients (≥65 years) with hematological malignancies that, while integrating the     essential dimensions of geriatric assessment and, with the same precision as the currently     available valid tools, is shorter and easier to apply, so it can be incorporated into the     daily practice and that aids in clinical decision making objectively.      If so, this information would help identify patients that could benefit from a specific     oncology treatment, thus contributing to developing a targeted intervention plan and to     optimizing the cancer results in this patient population.   "
85716|NCT02164058|"     The purpose of this study is to determine if a device known as the TandemHeart® System     (TandemHeart) can help limit heart damage and reduce serious complications after a certain     type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by     evaluating the use of the TandemHeart system prior to a procedure called percutaneous     coronary intervention (PCI)   "
85717|NCT02164045|"     The current food effect study is being performed to support a Phase 3 study with BMS 663068.     Results from this study will inform whether patients in the upcoming Phase 3 study can be     given the flexibility to dose BMS-663068 in the fasted state, if so desired.   "
85718|NCT02164032|"     Non-alcoholic fatty liver disease (NAFLD) is a common human liver pathology, closely     associated with the obesity pandemic and insulin resistance. In the insulin resistant state     the liver remains sensitive to pro-lipogenic signals of insulin, which further promote lipid     accumulation. Secretion of very-low-density-lipoproteins (VLDL), the main carriers of     triglycerides (TG) in the plasma, is the principal pathway for the liver to mobilize and     dispose of lipids. Thus, hepatic TG export must not be too low in order to prevent steatosis.     Our preliminary data from animal experiments suggest that enhanced brain insulin signaling     promotes hepatic VLDL secretion, and reduces lipid accumulation in the liver. It remains to     be tested whether other insulin sensitive tissues, such as the myocardium or the skeletal     muscle, are also affected. In humans, neuropeptides, including insulin, can be delivered to     the brain via an intranasal (IN) route of administration, without causing relevant systemic     side effects.      Therefore, we hypothesize that by enhancing brain insulin signaling using chronic IN insulin     administration hepatic TG export increases and prohibits lipid accumulation in the liver and     other insulin sensitive tissues, such as the myocardium and the skeletal muscle.   "
85719|NCT02164019|"     The purpose of this study is to look at two different types of surgeries regularly used for     treating cancer that has spread to and weakened the thigh bone (femur). Because it is not     known which of these surgeries is best, the investigators will compare the results of the two     procedures. They are looking to see if differences exist (after surgery) in function, quality     of life, pain control, and possible complications.   "
85720|NCT02164006|"     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in     combination with brentuximab vedotin in patients with hodgkin's lymphoma.   "
85721|NCT02163993|"     The main purpose of this study is to evaluate whether the study drug known as LY2951742 is     safe and effective in the prevention of migraine headaches. The study will last between 28     and 36 weeks.   "
85722|NCT02163980|"     The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX)     added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.   "
85723|NCT02163967|"     The hypothesis is that CES stimulation will dose dependently increase parasympathetic tone.     Healthy subjects will have three 20 minute sessions of CES stimulation, at three different     intensities of stimulation, with each session occurring on a separate day. Effect on     parasympathetic tone will determined by measuring high frequency heart rate variability     before, during and after the stimulation. The Fisher Wallace Stimulator (FW100) which     delivers a low dose alternating current a varying frequencies will be used for the     stimulation.   "
85724|NCT02163954|"     Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis     (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal     function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in     these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and     faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.   "
85725|NCT02163941|"     For individuals suffering from posttraumatic stress disorder (PTSD), the emotional numbing     and isolation that are a core aspect of their suffering and consistently impedes remediation     often remains after first-line treatments are administered. Few interventions have proven     successful for enhancing the empathy and social connectedness that will ultimately allow     patients to flourish, and the search for target therapies is made more difficult by the fact     that very little is known about the underlying physiology of emotional numbing and social     isolation. The proposed study is designed to (1) investigate the hormonal, neural and     immunological biomarkers related to emotional numbing, and (2) test whether cognitively-based     compassion training (CBCT), an intervention designed and proven to enhance empathy, will     reduce emotional numbing and increase empathy and social connectedness in veterans. To this     end, thirty medically healthy males diagnosed with PTSD who continue to report emotional     numbing symptoms after prolonged exposure therapy will receive 8 weeks of training in CBCT.     Prior to, and again after the training, the investigators will assess patients' levels of     oxytocin, inflammation, and self-reported emotional numbing and social connectedness. The     investigators will also assess their neural response during a video task that assesses their     ability to accurately read others' emotions. The investigators hypothesize that oxytocin,     neural activity, and inflammation will predict social numbing, isolation, and empathy, and     also that CBCT will positively impact the social outcomes that will pave the way toward     health and well-being.   "
85726|NCT02163928|"     Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study will     use Raman Spectroscopy to examine the ability of increased dietary intake of fruits and     vegetables to increase SCS in medical students. This will be an observational, non-invasive     study examining skin carotenoid levels over time in individuals who have increased their     intake by dietary adjustments. Thirty medical students meeting study inclusion criteria will     be asked to increase their intake of high antioxidant fruits and vegetables to 4-6 cups per     day over an eight week period of time. Students will self-select their fruits and vegetables     from a given list and will receive supermarket gift cards to offset the cost of the increased     food. Students will be asked to follow their usual diet for one week. Then increase their     intake of high antioxidant fruit and vegetable to 4-6 cups per day for eight weeks. Then     return to their usual diet for 2 weeks. SCS scores will be taken at baseline and week 1. At     the beginning of week 2, students will be asked to increase fruit and vegetable intake to 4-6     cups per day. SCS will be measured every two weeks during the 8-week intervention phase.     Students will return to their usual diet for 2 weeks and SCS will be measured at the end of     that 2-week period.   "
85727|NCT02163915|"     The purpose of this study is to characterize the safety and tolerability of TAK-137 when     administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder     (ADHD).   "
85728|NCT02163902|"     To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of     submental fat.   "
85729|NCT02163889|"     The objective of this study is to investigate T2Candida performance as a monitoring tool for     post-therapy clearance of Candida compared to blood culture.      This study will collect a T2clinical specimen and companion blood culture from patients who     have exhibited a positive blood culture by gram stain for yeast, and who are receiving     treatment with antifungal therapy.   "
85732|NCT02163850|"     Prospective, randomized, unblinded, multi-center investigational study with enrollment at up     to 45 investigational sites. The study is designed to compare the study device (Direct Flow     Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial     comparator (using approved Medtronic self-expanding bioprosthesis or Edwards     balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic     aortic stenosis. Subjects will be followed through the index procedure, hospital discharge,     and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual     follow-up at 2 through 5 years will be conducted and analyzed separately.   "
85733|NCT02163837|"     Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The     purpose of our study is to assess sleep quality, quantity, sleep schemes and physical     activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine,     which is currently given to lower blood ammoniac levels.   "
85734|NCT02163824|"     The primary purpose of this study is to determine the efficacy and safety of KPI-121     ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.     The efficacy and safety of two different concentrations and two different dosing regimens of     KPI-121 are also being assessed.   "
85735|NCT02163811|"     Lower extremity amputations are a significant cause of morbidity, mortality, loss of function     and reduced quality of life. Self-management (defined as the process by which an individual     adopts an active role in managing the symptoms, treatment, consequences, and lifestyle     changes inherent in living with a chronic condition) is an important mechanism for improving     health and reducing disability. This study will evaluate a 5-week group-based self-management     intervention for Veterans with lower extremity limb loss (VETPALS) and determine its impact     upon physical and psychosocial functioning, patient activation, self-efficacy, problem     solving, quality of life and positive affect. This study represents one of the only     prospective randomized controlled trials of a behavioral intervention for individuals with     limb loss. It is expected that results will be used to inform the integration of     self-management interventions into the VA Amputation System of Care. The specific primary     hypotheses are:        1. Individuals randomized to VETPALS will display greater improvements from baseline in          physical functioning as measured by the MFA-SF than Veterans in the individual education          support condition post-intervention and at a 6 month follow-up.        2. Individuals randomized to VETPALS will display greater improvements from baseline in          psychosocial functioning as measured by the PHQ-9 than Veterans in the individual          education support condition post-intervention and at a 6 month follow-up.   "
85736|NCT02163798|"     Cardiovascular diseases (CVD) accounted for major mortality and morbidity rates in Hong Kong     (HK) other than cancer. Increasing energy expenditure through regular exercise participation     has been found to lower the risk of CVD such as hyperlipidemia and obesity. Healthcare     professionals often prescribe lifestyle exercises for disease prevention, rehabilitation, and     health maintenance purposes. Previous study revealed that Tai Chi and walking were widely     practice by HK citizens. However, limited studies are found to compare the health benefits     between Tai Chi and walking. Do Tai Chi and walking have equally effective in raising     metabolic rate and reducing CVD risks? The difference in energy cost between a single bout of     Tai Chi and walking has not been documented. Limited studies report the effects of Tai Chi in     lowering the CVD risk. Since walking and Tai Chi are being heavily promoted in HK in recent     years, there is an urgent need to document the evidence of these two common forms of exercise     in terms of reducing CVD risks. Therefore, the purpose of the present study was to     investigate the energy costs as well as CV health benefits, in terms of aerobic fitness, body     composition, blood pressure, and blood lipid profiles, from the walking and Tai Chi exercise     in a sample of HK Chinese adults, and to compare the effects between these two exercises. The     investigators hypothesized that Tai Chi and walking had similar effects on improving energy     cost and reducing CVD risks.   "
85737|NCT02163785|"     Prospective multicenter randomized controlled trial comparing the prone vs. the supine     position of the perineal time of the Miles operation in patients with advanced rectal cancer.      Primary objective:      - Pathological circumferential resection margin      Secondary objectives:        -  5 year oncological outcomes        -  Morbimortality rates        -  Surgical specimen quality        -  Perineal hernia incidence   "
85738|NCT02163772|"     Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN)     injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes.     Although the long term treatment effect is encouraged, the point when to perform surgical     treatment is not conclusive. Previous reports suggested late treatment principle because     patients may spontaneous reinnervation to some degree within 4-5 months after injury. The     vocal cord position and tone may change during reinnervation. Others delineated laryngeal     synkinesis by misdirected reinnervation is common and suggested early temporary injection     laryngoplasty. They implied early injection laryngoplasty may improve patients'not only short     term voice outcomes but also decrease the incidence of transcervical laryngeal framework     surgery as a determined surgery. However, lacking of prospective study and objective data     makes the treatment-time policy still controversial. Purposes: 1. To find incidence of     spontaneous reinnervation or synkinetic regeneration. 2. To detect the relationship between     changing of glottal gap and laryngeal synkinesis. 3. To detect the impaction of early     intracordal hyaluronic acid injection on vocal cord position change in patients with     laryngeal synkinesis. Study design: Forty patients is planned to be enrolled in the study.     Twenty of them will undergo hyaluronate intracordal injection at three-six month from RLN     damage. The other 20 patients will follow the watch-and wait policy. Laryngoscope, laryngeal     EMG (electromyography), voice analysis and voice outcome survey will be done at 3-6 month and     12-month after RLN injury. At the end of follow up, the glottal gap, voice laboratory data     and quality of life will be compared. The outcomes will also be correlated with laryngeal     electromyography (LEMG) data and the impact of synkinetic reinnervation.   "
85739|NCT02163759|"     This Phase III, double blind, placebo and active comparator controlled, multicenter study     will investigate the efficacy and safety of etrolizumab in induction of remission in     participants with moderately to severely active UC who are naïve to TNF inhibitors and     refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.   "
85740|NCT02163746|"     This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa:     carbon dioxide (CO2) laser excision versus surgical deroofing.   "
85761|NCT02163473|"     The purpose of this research study is to determine if a chemical marker in the blood,     hypoxia-inducible factor (HIF-1 alpha), can be used to predict subject's hospital outcomes     when the subject is diagnosed with sepsis. Sepsis is defined as either the presence of     pathogenic organisms or their toxins in the blood and tissues. Sepsis is one of the most     significant challenges in critical care medicine. The investigators propose that     hypoxia-induced expression of HIF-1 alpha will correlate with the clinical features of Sepsis     and in the future, HIF-1 alpha may be used as a biomarker in Sepsis.   "
85741|NCT02163733|"     This is a 2-part study in patients with epidermal growth factor receptor mutation positive     (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an     epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will     determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow     patients further access to AZD9291 and will provide for additional safety data collection.      Part A is a randomised, open-label, 2 treatment period crossover study in which patients will     each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time     (approximately 0800) in each of 2 treatment periods (once immediately following a high fat     meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between     doses.      Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable     patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2     [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30     evaluable patients.   "
85742|NCT02163720|"     The French cooperative group GINECO proposes to implement an observational study to describe     a real situation, in daily practice tolerance and methods of administration of trabectedin     (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer     relapse.   "
85743|NCT02163707|"     Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of     mushrooms, collectively known as psilocybin mushrooms. Psilocybin     (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first     isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to     determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The     study is performed in support of Phase II and Phase III studies of psilocybin for the     treatment of refractory anxiety associated with incurable cancer, as well as other possible     indications. Psilocybin is at present not an FDA-approved drug.   "
85745|NCT02163681|"     The purpose of this study is to develop rapid MRI techniques for imaging the lung with     hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in     adults and older children before testing them in younger children and infants. The purpose is     to enable imaging of non-sedated infants by imaging so fast as to freeze motion.   "
85746|NCT02163668|"     This study examined the effects of 8 months of Yoga training on bone density and bone     turnover markers in premenopausal women, ages 35-50 years. The style of Yoga used was power     Yoga that involved postures with a jumping component. The investigators hypothesized that the     Yoga intervention would result in beneficial improvements in bone turnover markers, by     increasing the bone formation marker and decreasing the bone resorption marker.   "
85747|NCT02163655|"     The purpose of this study is to determine if furosemide administered after the first 24 hours     of delivery, in women with severe peeclampsia and eclampsia accelerates high blood pressure     control and diminishes hospital stay.   "
85748|NCT02163642|"     The purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial     peptides and Toll-like receptors is altered in certain patients with non-CF bronchiectasis,     which makes them more susceptible to be infected by potentially pathogenic bacteria (PPB);     and 2) the electronic nose is able to detect patterns of specific Volatile Organic Compounds     (VOC) for patients with non-CF bronchiectasis colonized by PPB.   "
85749|NCT02163629|"     In spite of major medical advances in heart transplant patients, psychiatric comorbidity     remains very high in pre-and post-transplant phases. Anxiety and depression are especially     frequent. They impact significantly morbidity and mortality. Especially because they are     associated with poor therapeutic adherence and risks of infection and rejection. The     inability to make beneficial therapeutic choice can be explained by the negative perception     of events, associated with anxio-depressive disorders. This results in an important     deterioration in quality of life of patients.      The investigators assume that better management of emotions might reduce the stress of     waiting situation and its psychopathological and somatic consequences pre-and     post-transplant.   "
85750|NCT02163616|"     This study seeks to assess whether populations of women in Latin America outside Quito,     Ecuador are at increased risk for developing elevated body temperature above 40.0°C following     PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals     representative of different regions of Latin America to explore environmental and genetic     hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss,     pulse and blood pressure will be systematically measured for all women enrolled to explore     new clinical indicators for identifying women who require clinical intervention for excessive     bleeding. Blood samples will be collected among women treated with misoprostol to investigate     genetic factors responsible for elevated body temperature induced by misoprostol.      The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol     treatment (800mcg given sublingually) will be variable across settings. The investigators     expect that the side effect profile following 800 mcg misoprostol given sublingually, in     particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous     results using misoprostol for PPH.   "
85751|NCT02163603|"     Developmental dislocation of the hip is a common disease in children, and its incidence in     China is about 9 ‰.The pathological changes of it is complex. The reluxation , subluxation     and residual deformity and other complications are relatively common after treatment. The     X-ray appears great acetabular index and wide medial gap , small central-edge angle. As there     is no effective methods for treating such complications , investigators conducted this trial     to find and prove optimal intervention time and treatment programs.   "
85762|NCT02163460|"     The aim of this study was to perform a randomised clinical trial comparing the use of     closed-suction tubular drains and progressive tension sutures in individuals with large     incisional hernias subjected to onlay mesh repair to evaluate the occurrence of seroma and     surgical wound infection after surgery.   "
86168|NCT02158156|"     The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can     improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.      Participants will be evaluated on maximal oxygen consumption and maximal workload measured by     an incremental test at baseline and at the end of the exercise period.   "
85973|NCT02160691|"     The purpose of the study is to determine if a new device, called the Anxiety Meter, improves     recognition and management of psychological arousal associated with anxiety in children with     ASD.   "
85752|NCT02163590|"     Passive mobilizations of the spine are widely used by physiotherapists in the management of     neuromusculoskeletal disorders.      There is a nascent body of work of the mechanical properties of joint mobilizations.     Treatment dose is characterized by the direction of force applied, magnitude of force     applied, frequency of oscillation, amplitude of displacement, repetition and time. Although     the choice of better treatment dose is based on patient complaints and clinical reasoning,     the comprehension of the effects of different parameters of joint mobilization will improve     the decision making process. The optimal dose of treatment, however, is not already known.      The primary aim of this study is to determine whether different rates of thoracic     mobilization are capable to produces hypoalgesic effects, and secondarily investigate if such     effects are local or widespread.   "
85753|NCT02163577|"     UX023-CL201 is a randomized, multicenter, open-label, dose finding, Phase 2 study. The study     will be conducted in prepubescent children aged 5-12 years with XLH to assess the     pharmacodynamics and safety of KRN23 administered via subcutaneous injections monthly (every     4 weeks) or biweekly (every 2 weeks) for a total of 64 weeks. The study consists of a 16-week     individual dose Titration Period, followed by a 48-week Treatment Period. The study will     enroll approximately 50 pediatric patients with XLH and radiographic evidence of bone     disease. Subjects will need to discontinue oral phosphate and vitamin D metabolite therapy     prior to randomization and throughout the duration of the study.   "
85754|NCT02163564|"     Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90%     of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse     and recurrence of depressive episodes, unintentional injuries, poor school performance,     substance use, obesity, and the risk for suicide. This project seeks to develop a     nonpharmacological treatment for insomnia in adolescents with depression that is feasible and     effective. The specific methodologies that will help accomplish these results are: 1) use of     focus groups of adolescents with depression and insomnia to determine how the current     standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for     insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2)     determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in     adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This     project will help to improve the quality and scope of delivery of mental health services in     Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate     depression in adolescents and b) to provide mental health professionals with a     nonpharmacological treatment option for insomnia in adolescents with depression.   "
85755|NCT02163551|"     Dyspnea is a subjective experience of breathing discomfort that consists of qualitatively     distinct sensations that vary in intensity. It is known that sensory information from the     respiratory system activates regions of the cerebral cortex to produce the perception of     dyspnea but far less is known about the neurophysiology of dyspnea than about vision,     hearing, or even pain. Dyspnea likely arises from multiple nervous system sources, but the     exact locations have not been well identified. Investigations of the mechanisms underlying     respiratory sensations have included studies of airway anesthesia, chest wall strapping,     exercise, heart-lung transplantation, hyperventilation, and opioid use. Study of the     perception of breathing sensations in individuals with a spinal cord injury presents     additional opportunity. The goal of the proposed project is to examine the effects of     increasingly severe levels of spinal cord injury on the perception of breathing sensations in     participants who are able to breathe without the use of a ventilator. The investigators     hypothesize that the perception of breathing varies with the extent of somatosensory     information that reaches cerebral cortex.   "
85756|NCT02163538|"     This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index)     ergonomic assessment tool to detect differences in surgeon workload when using commercially     available advanced bipolar devices. It is anticipated that the raw-TLX version of the     validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the     procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also     positively impact other variables such as blood loss, operative time and cost.   "
85757|NCT02163525|"     This Post Market study is being conducted to compare the direct and indirect cost of three     approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of     symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the     requirements of the United States Food and Drug Administration's 522 (post market     surveillance) order.   "
85758|NCT02163512|"     Multicentric, observational and prospective study with two groups of treatment: Refractory     ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic     blockers as primary or secondary profilaxis for variceal bleeding.   "
85759|NCT02163499|"     The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed     with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance     Phase.   "
85760|NCT02163486|"     Airway management is one of the basic topics in anesthetic practice. Use of endotracheal     intubation and face mask are standard methods to maintain an open airway widely adopted for     many years. As a result of a search for more appropriate choices from the point of view of     effectiveness, reliability and side effects, supraglottic airway devices (SGAD) have been     developed.      SGAD's are used for thyroid surgery, ear surgery, carotid endarterectomy, adenotonsillectomy     and laser pharyngoplasty, which require a variety of head-neck positions. Changing the head     and neck position leads to changes in the shape of the pharynx, which causes variation in the     cuff pressure and oropharyngeal leak pressure. Oropharyngeal leak pressure values play a     determining role in protecting the airway from high cuff pressure. Additionally it shows that     the laryngeal mask is correctly placed and is a sign of the effectiveness of positive     pressure ventilation. During surgery head-neck and trunk position may change. As a result     there is a need for research evaluating the effect of head and neck position on oropharyngeal     leak pressure during SGAD use.      AIM      The aim of this study is to compare the effect of different head and neck positions on the     oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Additionally the placement     duration, ease and success of these two supraglottic airway devices will be compared.   "
86169|NCT02158143|"     evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young     people.   "
85763|NCT02163447|"     This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected     pregnant women and the children born to them. The study interventions will be divided into     two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be     randomized in equal proportions to one of three intermittent preventive therapy in pregnancy     (IPTp) treatment arms: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of     dihydroartemisinin-piperaquine (DP), or 3) monthly DP. All three interventions arms will have     either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the pregnant     women will end approximately 6 weeks after giving birth. In the second phase of the study,     all children born to mothers enrolled in the study will be followed from birth until they     reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP during     pregnancy will receive DP every 3 months between 2-24 months of age. Children born to mothers     randomized to receive 3 doses of DP or monthly DP during pregnancy will receive either DP     every 3 months or monthly DP between 2-24 months of age. To ensure adequate blinding,     children who will receive DP every 3 months will be given DP placebo during the months they     will not be taking DP. Children will then be followed an additional year between 24-36 months     of age following the interventions. We will test the hypothesis that IPT with DP will     significantly reduce the burden of malaria in pregnancy and infancy and improve the     development of naturally acquired antimalarial immunity.   "
85764|NCT02163434|"     The investigators will compare the effectiveness of gabapentin to metoclopramide for 1-2     weeks among 80 women with hyperemesis gravidarum (HG) in this randomized, double-blinded     trial. After completion of the 2-week double-blind phase, subjects will be offered open-label     gabapentin with rescue metoclopramide until their symptoms no longer require treatment.     Enrollment will occur at the University at Buffalo and the University of Rochester.   "
85765|NCT02163421|"     The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of     vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.   "
85766|NCT02163408|"     This is a technical development study with the goal to develop 3D techniques for     atherosclerosis plaque characterization. We hypothesize that 3D MRI is superior to 2D MRI in     characterizing major plaque constituents that contribute to severe clinical events such as     myocardial infarction or stroke. The major advantages of the 3D techniques to be developed     will include high spatial resolution, reduced scan times, and optimized image contrast. The     use of contrast injection is not needed with the new techniques, which is greatly beneficial     for patients with advanced chronic kidney disease.This is not a funded clinical trial.   "
85767|NCT02163395|"     -  Straumann Monotype FullCeram implants serve as a suitable alternative for implant          therapy especially in the aesthetic zone        -  The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant          losses out of 40 patients) after the first year   "
85768|NCT02163382|"     Mechanical ventilation permits to support the work of breathing in case of respiratory     failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which     delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these     complications. However, NIV is not always successful and half of children in respiratory     failure finally require invasive ventilation. A major cause of NIV failure is the ventilator     inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted     ventilatory assist) improves the detection of patient efforts during mechanical ventilation.     The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and     therefore permits to unload the patient ventilatory efforts.   "
85769|NCT02163369|"     The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to     medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness     to relieve symptoms of nausea or vomiting and/or anxiety.      Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety.     This study will involve administration of aromatherapy to a convenience sample of patients,     who will then be asked to complete a brief questionnaire. The questionnaire will involve a     simple likert scale to measure efficacy (in the opinion of the patient) and simple     multiple-choice questions to determine patients' likeliness to use aromatherapy again.   "
85770|NCT02163356|"     Currently there is no known effective treatment for recurrent or resistant neuroblastoma.     Fenretinide is an anticancer agent that may work differently than standard chemotherapy. It     may cause the buildup of wax-like substances in cancer cells called ceramides. In laboratory     studies, it was found that if too much ceramide builds up in the neuroblastoma cells, they     die.      Fenretinide has been given by mouth as a capsule to many people, including children. When     Fenretinide is given in capsules, very little of the drug is absorbed through the intestines     into the body. This means patients have to take many capsules of fenretinide by mouth several     times a day. In this study, a new oral preparation of fenretinide (called 4-HPR/LXS oral     powder) is being tested to see if more fenretinide can be absorbed into the body. 4-HPR/LXS     oral powder has been tested previously in a limited number of both children and adult cancer     patients.      Ketoconazole, commonly used to treat fungus infections, can increase fenretinide levels in     the body by interfering with the body's ability to break down fenretinide. Ketoconazole will     be given at the same time as the fenretinide powder.      There is preclinical data that shows that combining fenretinide and vincristine prolonged     survival in animal models, therefore, it is hoped that giving the vincristine with     fenretinide will work better against the neuroblastoma that either drug given alone.      About 70 children with neuroblastoma have been treated with various versions of the     fenretinide powder to date, including about a dozen children that also took the fenretinide     powder with ketoconazole, and no toxicities have occurred that limited the dosage and no     serious or unexpected side effects occurred. However, vincristine has never been given with     fenretinide or fenretinide plus ketoconazole before. Vincristine has been been given before     with ketoconazole to both children and adults with neuroblastomas and other cancers.   "
85771|NCT02163343|"     Elevated serum metal ions are well recognized in metal-on-metal articulations in total hip     replacements. The objective of the study is to see if the Cathcart / Corail device implanted     during a hemiarthroplasty (replacement of one half of the hip joint) results in elevated     serum metal ion levels (cobalt & chromium) and to see if there is an association between size     of Cathcart head used and metal ion levels.   "
85772|NCT02163330|"     Normal pressure hydrocephalus (NPH) is an uncommon cause of dementia possibly reversible with     treatment. First described in 1965 it consists of a triad of gait disturbance, cognitive     deterioration, and urinary incontinence together with enlarged cerebral ventricles and normal     cerebrospinal fluid (CSF) pressure. Foregoing trauma and hemorrhage, infection, mass lesions,     or aqueductal stenosis can contribute to hydrocephalus. These symptomatic or secondary forms     of NPH are not considered here and the focus lies on the idiopathic type (iNPH). Prevalence     of iNPH increases significantly with age. General estimates range from 21.9 per 100,000 in     total population surveys but increase up to 181.7 per 100,000 for people 70 to 79 years of     age. The clinical presentation varies significantly in severity and progression of symptoms.     For diagnosis the entire triad does not have to be present. In typical cases gait and balance     disturbances appear either before or concurrently with urinary incontinence or the onset of     dementia. Current treatment recommendations are based on surgical diversion of CSF , with     shunts placed either into the ventricular system or the lumbar subarachnoid space to a distal     site, such as the peritoneal or the pleural cavity or the venous system, where the CSF can be     reabsorbed . Even though immediate response rate to shunt treatment might be favorable and     rates of 80% responders have been reported , the perioperative and long-term morbidity and     mortality of CSF shunting procedures are significant. A meta-analysis of 44 articles found     that the pooled, mean rate of shunt complication was 38% . Even though acute surgical     complication rates are low, shunt dysfunctions and long-term complications are relatively     common. Shunt malfunction (20%), subdural hematoma (2-17%), seizure (3-11%), shunt infection     (3-6%) and intracerebral hematoma (3%) are the most common complications . In those with good     long-term survival, sustained improvement is possible, with a rate of 39% documented after 5     years .In view of the complication rates, the lack of alternative treatment options and     clinical studies is surprising. Even though iNPH per definition lacks raised intracranial     pressure on spinal tap, monitoring of ICP prior to surgery reveals an increased amount of     brief (usually 30 seconds to 1 minute) increases in the static ICP, called Lundberg B waves,     in patients which improve by shunt placements . When patients are scheduled for shunt     treatment there is a waiting period of several weeks between diagnosis and operation due to     congested waiting list.      Acetazolamide (Diamox) has been shown to reduce the production of CSF in clinical cases of     raised intracranial pressure . It is considered the drug of choice for the treatment of     idiopathic intracranial pressure (pseudotumor cerebri). Intuitively a connection between     Acetazolamide as a treatment option in iNPH seems logical. Encouraging case studies have been     published previously showing a fascinating improvement and success of treating iNPH with     Acetazolamide. A systematic placebo controlled study concerning the use of Acetazolamide in     iNPH is missing and would possibly pave the way to an alternative treatment option avoiding     surgery and its complications.   "
85773|NCT02163317|"     This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic     radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate     cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause     less damage to normal tissue.   "
85820|NCT02162693|"     Current medication treatments for KOA aim to relieve inflammation and pain, but they do     little to delay or reverse the disease progression and most medications have obvious side     effects. When the conservative treatments are useless to patients and joint deformities and     joint disfunction, the patients may require surgery. Although surgery of the joints can     relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.   "
85774|NCT02163304|"     The primary purpose of this study is to quantify activation of regions of the brain     associated with taste, appetite, and reward after viewing high sugar and high fat (HS/HF)     images compared to control images following ingestion of (1) an artificially sweetened     solution, (2) a sucrose solution, and (3) a tasteless control solution in normal weight vs.     obese women. This is a repeated measures study design; hence, data are collected on three     days corresponding to the three solutions. Body mass index (BMI) is a between subjects     measure.        1. After consuming an artificially sweetened solution and a sucrose solution compared to a          tasteless solution, viewing HS/HF food images vs. control images will result in higher          activation of taste pathways (frontal operulum and anterior insula (FO/AI)) in the          brain.        2. After consumption of a sucrose solution compared to an artificially sweetened solution          and a tasteless solution, viewing HS/HF food images vs. control images will result in          higher activation of regions of the brain associate with appetite (hypothalamus).        3. After consumption of a sucrose solution compared to an artificially sweetened solution          and a tasteless solution, viewing HS/HF food images vs. control images will result in          higher activation of regions of the brain associated with reward [amygdala, anterior          cingulate cortex (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA),          striatum, insula] in obese but not normal weight women. After consuming an artificially          sweetened solution compared to a tasteless solution, viewing HS/HF images vs. control          images will result in no differences in activation of reward pathways of the brain.   "
85775|NCT02163291|"     Gastric cancer is the second cause of cancer related death and China has the most gastric     cancer patients in the world. Although systemic strategies, including adjuvant chemotherapy,     postoperative chemoradiotherapy, perioperative chemotherapy, have evolved and showed benefits     these years, the prognosis of advanced gastric cancer is still not satisfactory. Optimal     regimens and optimal method administration is still being found. Neoadjuvant chemotherapy has     many advantages, including downstaging the tumor, increasing R0 rate, early eradicating of     micrometastasis. In previous trials, combination of paclitaxel and s-1 has showed safety and     tolerance in recurrent or metastatic gastric cancer. Using liposome as a carrier, paclitaxel     has a better histocompatibility and cellular affinity, resulting a improved stability and     reduced toxicity. In this phase II trial, we are going to study the safety and feasibility of     paclitaxel liposome plus s-1 as neoadjuvant chemotherapy.   "
85776|NCT02163278|"     The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and     pharmacodynamic (PD) properties of multiple oral doses of DBPR108 in healthy male subjects.   "
85777|NCT02163265|"     Pectus excavatum or carinatum are the most common congenital deformations of the ventral     thoracic wall. Several different surgical methods with different techniques to correct these     deformations have been described.      Some clinicians recommend a correction of the deformation to improve the cardiopulmonary     efficiency. Other think that the correction has a more an aesthetic than a physiological     benefit.      The aim of our prospective study is to evaluate whether patients with PE or PC are suffering     preoperatively from a cardiopulmonary limitation at rest and under physical stress and if     there is a change of cardiopulmonary function after the surgical correction.   "
85778|NCT02163252|"     The purpose of this study is to examine whether providing additional intervention support to     individuals with lower than expected weight loss within the initial stages of an     internet-based behavioral weight loss program improves weight loss outcomes at Week 12,     compared to the internet program alone.   "
85779|NCT02163239|"     This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula     and Oburator during standard robotic laparoscopic single-site surgery. The study will     evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci®     Robotic Surgical System during single-site laparoscopic surgery.   "
85780|NCT02163226|"     The goal of this clinical research study is to learn if 1 large dose of radiation therapy is     better at controlling pain from cancer that has spread to the bones than 10 smaller doses of     radiation. Researchers also want to learn if 1 large dose of radiation therapy can help     decrease the use of drugs to control the pain, and if it can help to control the disease.   "
85781|NCT02163213|"     To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine     Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal     expression of pivotal genes including tight junction, secretory mechanisms, tissue repair     proteins and chemokines in subjects with IBS-D.   "
85782|NCT02163200|"     Patients candidates for total hip replacement are, generally elderlies and have hip pain, we     will check if the pressure to the soft tissue changes before and after operation using a     tapet with pressure sensors sending the information to specific software.   "
85783|NCT02163187|"     The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will     help patients to have more normal bowel movements. The InterStimTM device is a     neuromodulating device. Neuromodulation is a way of changing the activity of the nervous     system by using electrical stimulation. InterStimTM is FDA approved to help people who have a     hard time controlling their bowl movements. This is called fecal incontinence.The device is     placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by     releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is     initially tested to make sure it will work using a temporary wire and then, if successful,     the device is permanently implanted.   "
85784|NCT02163174|"     -  Hypothesis: The investigators hypothesized that Pentoxifylline has potent          anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in          treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal          mortality and morbidity.        -  The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an          adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.   "
85785|NCT02163161|"     Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a     solid dose formulation of PF 04965842 relative to a suspension formulation under fasting     conditions and the effect of food on the bioavailability of the solid dosage formulation of     PF 04965842 in healthy subjects.   "
90351|NCT02103439|"     The purpose of the study is to demonstrate the noninferiority of Algeron in combination with     ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic     hepatitis C in Human Immunodeficiency Virus-1 infected patients   "
85786|NCT02163148|"     Anxiety disorders are common and impairing. Although exposure therapy is one of the most     effective treatments for anxiety, some individuals do not fully respond to treatment, and     these individual differences are not well understood. Exposure therapy involves repeated,     deliberate, safe engagement with a feared stimulus without the feared outcome occurring. This     treatment is thought to work through a type of emotional learning called fear extinction.     This study aims to look at links between fear extinction learning and exposure success, with     the overall goal of better understanding who is likely to respond best to exposure therapy     and why.   "
85787|NCT02163122|"     This is a pilot trial in cat allergic participants, designed to compare allergic responses in     each participant to a specific allergen by two methods of exposure. The methods of exposure     to be used are: the environment exposure chamber (EEC) and nasal allergen challenge (NAC).     Potential participants will be screened for evidence of cat allergy.      Participants with a range of allergic sensitivities to cat allergen will be enrolled. To help     ensure some breadth in the level of allergic sensitivity among participants, individuals with     both high and low exposures to cat allergens in their daily lives will be enrolled.   "
85788|NCT02163109|"     Many serious illnesses are characterised by a lack of oxygen delivery to the body's tissues.     This can be due to problems with the circulation, such as when the heart fails to pump blood     efficiently or if the blood pressure is very low, or due to changes in the lungs preventing     them from transferring oxygen effectively from the air into the blood.      Many of the treatments used in critically ill patients are aimed at improving the supply of     oxygen-rich blood to the tissues. These include drugs to increase the blood pressure or make     the heart pump more forcibly, blood transfusions to increase the amount of oxygen that the     blood can carry, and ventilators (breathing machines) to help the lungs introduce more oxygen     into the bloodstream. Decisions to use such treatments are based on a number of factors. One     of the most important is an assessment of how much oxygen an individual patient is using at a     given time. Whilst it is possible to measure average oxygen consumption over a long period of     time in healthy individuals, the equipment and techniques needed are simply not practical for     routine use in the clinical setting of a critical care unit. Critical care doctors and nurses     therefore have to rely on a number of different indicators of the adequacy of the amount of     oxygen that is being provided in order to make decisions about how best to treat patients.     Unfortunately, all of these have their limitations, are affected by other treatments patients     may be receiving, and can be difficult to interpret. Examples include 'mixed venous oxygen     saturation' (SvO2), that is the amount of oxygen in the blood coming back to the lungs from     the body, ready to have more oxygen added, and blood lactate levels, which give an indication     of whether the tissues have enough oxygen to produce the energy they need to function in an     efficient manner.      Our group has developed a device which can be added easily to the normal equipment used on a     critical care ward when a patient is on a ventilator, which can accurately and rapidly     measure the amount of oxygen the individual is consuming.      This study will provide us with data so the investigators can define a normal range of     oxygen consumption in these patients, and treatments which alter consumption. In a future     study, once the investigators know what the normal range is, they can introduce new     techniques to improve oxygen consumption in those patients whose consumption is less than     ideal.   "
85789|NCT02163096|"     The purpose of this study is to assess benign joint hypermobility syndrome (BJHS) in children     with a history of wheezing or asthma. BJHS is a common syndrome of joint and connective     tissue laxity without any other rheumatologic disease. This assessment will be performed by     using either method below depending upon if the child has a history of wheezing or severe     asthma:        1. Determine the correlation, if there is an increased rate of BJHS in children with a          history of wheezing as well as if there is an increased history of wheezing in children          with BJHS; or        2. Determine asthma control, lung function and asthma exacerbations (a flare up or acute          worsening of symptoms) in children with BJHS compared to children with asthma without          BJHS, to assess if it BJHS is associated more with children with severe asthma.   "
85790|NCT02163083|"     The purpose of this study is to investigate, whether the detection of lymph nodes by means of     intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical     prostatectomy is higher than without the use of indocyanine green (ICG).   "
85791|NCT02163070|"     The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on     nutritional status, inflammatory markers and oxidative stress in hemodialysis patients   "
85792|NCT02163057|"     This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and     immunogenicity of INO-3112 DNA vaccine delivered by Electroporation to subjects with HPV     associated head and neck squamous cell cancer.   "
85793|NCT02163044|"     Coronary heart disease (CHD) is the leading cause of death worldwide. The disease is     characterized by a high mortality rate (about 40%) and a course continuously altered by     lifestyle, gene polymorphisms and therapeutic treatment. Fasting concentration of blood     lipids and lipoproteins only partially express the complex relation between dyslipidemia and     CHD. Following the indication stated nearly 40 years ago by Zilversmit, there is now     accumulating evidence that postprandial lipemia plays an important role in the atherogenic     process [ref Kolovou], particularly that most hours of the day are spent in the postprandial     state. Furthermore, the increases in blood glucose and triglycerides (TGs) following meals     stimulate oxidative stress, impair endothelial function, and rises the inflammatory factors     that lead to atherosclerosis. Previous studies reported on postprandial lipemia in subjects     with obesity, metabolic syndrome, diabetes mellitus, elderly, patients with CHD and others.     However, currently the estimation of cardiovascular disease risk is based on fasting blood     values of triglycerides (TGs) and inflammatory markers. The effect of postprandial     atherogenic factors on the initiation and progression of atherosclerosis is actually not     known.The Hellenic Postprandial Lipemia Study (HPLS) was designed to study the consequences     of postprandial lipemia in CRP as inflammatory marker in high-risk adults. Furthermore, the     HPLS study will investigate whether hypolipidemic, hypoglycemic or antihypertensive     medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal     postprandial metabolism. Finally, the HPLS study is intending to evaluate the influence of     gene polymorphisms involved in lipid and glucose metabolism on postprandial lipemia and     cardiovascular outcomes.   "
85816|NCT02162745|"     Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of     life. Most children with bronchiolitis have mild disease and are managed at home with support     from primary care providers, while children with more severe symptoms require supportive     therapy with oxygen and fluid administration.      Neonates may be obligate nasal breathers until they are at least 2 months old and nasal     obstruction may play a relevant role in respiratory resistances throughout the first months     of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance.     Some guidelines recommend to clear the nostrils of secretions to improve airway patency but     no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was     carried out.      The aim of this randomized controlled trial is to compare normal saline and hypertonic     solution for nasal irrigation versus simple supportive care in infants admitted to Emergency     Department with bronchiolitis and mild desaturation.   "
85794|NCT02163031|"     Orthotopic heart transplantation is a well established therapeutic measure for end stage     heart failure, leading to significant improvements in survival and quality of life. In the     routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac     catheterization for early detection of allograft vascular disease.      The coronary angiography of these patients is characterized for several technical     difficulties, generally related to the presence of the aortotomy with anomalous implantation     of the coronary ostia and to the orthotopic position of the allograft. For these reasons,     trans femoral approach is usually preferred. In the last two decades, trans radial approach     for coronary angiography emerged to be effective, safe and able to improve patient comfort.     However, there is no universal consensus on the optimal choice of radial access from either     the left or the right artery. Currently, this choice is largely dependent on the operator's     preference. The trans right radial approach is generally preferred in routine clinical     practice mainly due to its easier catheter manipulation for the operators from patient's     right side, and the current design of radial compression devices for the right wrist in     medical market. As such, a major barrier to prevent the wide adoption of the left radial     access lies in some difficulty to reach the left wrist leaning over the patient, particularly     for shorter operators or in obese patients. However, a great deal of attention has been     recently directed toward the trans left radial access, as it has an important anatomical     advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the     left coronary ostium, which could also reduce the risk of cerebrovascular complications.      However, no data are available about the performance of trans left radial or trans-right     radial approach in coronary angiography orthotopic heart transplantation patients. However,     in this particular setting of patients, the left radial approach might reduce the technical     difficulties related to the anatomical variations.      In this single centre, prospective, randomized study, we sought to compare trans right radial     versus trans left radial approach in terms of amount of contrast medium, radiation exposure,     number of catheters used, cross over to the other access site rate and local and systemic     complications in orthotopic heart transplantation patients.   "
85795|NCT02163018|"     Currently, there is no effective causal treatment for peanut allergy. A chemically modified,     aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has     been developed. Results from in vitro and in vivo preclinical studies demonstrate the     immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial     has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic     patients.   "
85796|NCT02163005|"     Patients with an allergy to iodine based intravenous contrast cannot undergo a CT scan with     contrast, unless they are premedicated. Premedication can result in a delay in diagnosis,     that can be significant with acute conditions such as Pulmonary embolism.      The investigators are evaluating the use of Gadolinium as an alternative contrast agent in     CT. Gadolinium has been used extensively in MRI exams but the dose that is used is not     sufficient to provide good enhancement on CT. Dual Energy CT is a new technology that has     better sensitivity to lower doses of intravenous contrast and the investigators aim to study     its effectiveness in improving the enhancement with Gadolinium. The investigators will     compare enhancement of Iodine with enhancement of Gadolinium during Dual Energy CT, to assess     the possibility that Gadolinium could be used as an alternative for patients who are     suspected of having Pulmonary embolism. They will recruit up to 50 patients who are having a     routine Chest CT during treatment for a malignancy and administer Gadolinium contrast and     Iodine contrast during a chest CT exam. The enhancement with the two agents can be compared.   "
85797|NCT02162992|"     Connective tissue diseases have been related to heart conduction disorders. The anti-Ro/SSA     antibodies are thought to have a pathogenic role, and they most prevalent in systemic lupus     erythematous (SLE). The aim of this study is to evaluate the relationship between SLE,     arrhythmias and its serologic profile.   "
85798|NCT02162979|"     This study is to determine if Viagra is effective in reducing dyskinesias in patients with     Parkinson's Disease.   "
85799|NCT02162966|"     Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post     antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa,     Acinetobacterbaumannii, and Klebsiella pneumonia.   "
85800|NCT02162953|"     Background: Autosomal recessive bestrophinopathy (ARB) is one of 5 blinding eye diseases     caused by mutations in the gene BEST1. These diseases, collectively termed     bestrophinopathies include ARB, Best vitelliform macular dystrophy (BVMD), adult-onset     vitelliform dystrophy (AVMD), autosomal dominant vitreoretinalchoroidopathy (ADVIRC) and     retinitis pigmentosa (RP) .      Objective: To collect DNA/RNA and skin samples from individuals with ARB or other diseases     due to mutations in the gene BEST1. These models will be used to identify and test     therapeutic approaches to treating these diseases.      Design: Study involves a one time donation of a skin punch biopsy and whole blood. Once the     skin biopsy is obtained, skin fibroblasts will be isolated, which will be reprogrammed into     iPSCs. RPE cells will be derived from the iPSCs   "
85801|NCT02162940|"     The impact of statin use on response to epidural steroid injections remains unknown and may     well increase the effect considering the substantial anti-inflammatory properties. We thus     tested the primary hypothesis that patients taking statins before and after the procedure     will have lower VAS scores compared to patients not on statins. Secondarily we tested the     hypothesis that statin users will have improved quality of life evaluated with Short Form 36     (SF 36).   "
85802|NCT02162927|"     In the past, dietary nitrate supplementation has been shown to have clinical benefits in the     treatment of cardiovascular issues. More recently, however, the focus of nitrate     supplementation has shifted to focus of human performance, and has shown to increase the time     to exhaustion during maximal intensity exercise and lower the cost of oxygen consumption     during submaximal intensity exercise. Acutely, nitrate supplementation in the form of     beetroot juice has been shown to increase strength measurements, as well as increase the time     to complete a 2000 meter rowing ergometer test. However, to the author's knowledge, there are     no studies that link the relationship between multi-day nitrate supplementation and the     rowing test or the nitrate's effect on strength when in the salt form. Additionally, to the     author's knowledge, no evidence has been published which relates dietary nitrate     supplementation and its effects on a CrossFit circuit workout.      Our central hypothesis is that six days of dietary nitrate supplementation will improve     strength, endurance, a power more than a placebo in male CrossFit athletes.   "
85803|NCT02162914|"     The study is a multicenter randomized (1:1) placebo-controlled, double-blinded phase II trial     aiming to demonstrate an improvement of median PFS when treating locally advanced     unresectable or metastatic patients suffering from an intra-hepatic or hilum (mass-forming)     cholangiocarcinoma with Regorafenib as compared to placebo, and after progression after     GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum (CDDP or     oxaliplatin)-based chemotherapy.      The principal objective is to investigate Regorafenib efficacy by prospectively evaluating     the PFS after the administration of Regorafenib combined with BSC as compared to placebo with     BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in Regorafenib     group).   "
90363|NCT02103283|"     A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular     Edema.   "
85804|NCT02162901|"     The aim of this project is to evaluate the reach, effectiveness, and costs of two     patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate     and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired     glucose tolerance) within a health care setting. The overall aim is consistent with the     NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and     community-based strategies for prevention of diabetes and its complications. While evidence     of lifestyle interventions that increase physical activity and improve eating habits to     achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues     to mount, the translation of these interventions into effective programs to health care     settings with modest resources remains a challenge. The proposed research project will     conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled     Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in     achieving objectively verified weight loss relative to a standard care control at     comparatively lower costs. Adult patients (18 years of age and older) at risk for developing     diabetes will be randomized to either the Choice group or the Randomization group. Those     patients randomized to the Choice group (n=240) will have the opportunity to choose one of     two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated     interactive voice response (IVR) systems targeting personal action planning to support     lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention     with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be     randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC).     SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures     include weight loss, cost, and reach of each program. Secondary outcome measures include     physical activity behavior; eating behavior; and process evaluation. It is hypothesized that     both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of     weight loss at 6, 12, and 18 months following program initiation than SC but will not differ     from one another. The investigators also hypothesize that the DVD/IVR will have broader reach     and may be more cost-effective than SG/IVR or SC.   "
85805|NCT02162888|"     The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM)     Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in     patients with cancer.   "
85806|NCT02162875|"     The objective of this study is to determine the strategy for mass drug administration (MDA)     which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in     school-aged children after 4 years of intervention.   "
85807|NCT02162862|"     The purpose of this study is to determine if either a targeted type of talk therapy (Phase I)     or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals     with Inflammatory Bowel Disease (IBD).   "
85808|NCT02162849|"     The goal of this clinical research study is learn if varenicline or the nicotine patch can     help people with different types of emotion and attention levels to quit smoking.   "
85809|NCT02162836|"     The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in     Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate     cancer that is resistant to medical [for example. hormonal] or surgical treatments).   "
85811|NCT02162810|"     The primary objective of this study is to determine the efficacy of administering a course of     postoperative oral steroids in pediatric patients undergoing proximal hypospadias repair as     prevention against complications. Specifically, the study aims to assess if the steroids i)     decrease the incidence of wound breakdown, fistula formation, stenosis or stricture     formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and     ii) improve the quality of wound healing including the overall cosmetic appearance of the     phallus (i.e. location of the urethral meatus).   "
85812|NCT02162797|"     INTRODUCTION:      An adequate zinc supplementation is essential for a good immunological function. However,     zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and     efficiency of zinc supplements in the progression of HIV is evaluated in the short-term.      HYPOTHESIS      Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV     patients after three months of daily consumption.      Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV     patients after three months of daily consumption   "
85813|NCT02162784|"     The objective of the study is to evaluate the dose response of SYN006 HFA MDI, which is a     combination drug product of budesonide and procaterol hydrochloride, in asthma patients.     Patients with mild to moderate asthma will be recruited. There will be two study medication     administered in this study. The investigational medication is SYN006 (Budesonide/Procaterol     hydrochloride, 180 mcg/10 mcg per inhalation) and the active comparative medication is     Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study medication will be     administered by oral inhalation with the supervision of the investigator or a qualified     staff.   "
85814|NCT02162771|"     This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double     blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate     equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of     CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients     with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.   "
85815|NCT02162758|"     This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice     daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who     achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD)     following radiofrequency ablation (RFA).   "
85817|NCT02162732|"     The purpose of this study is to test the feasibility (ability to be done) of experimental     technologies to determine a tumor's molecular makeup. This technology includes a genomic     report based on DNA exomes and RNA sequencing that will be used to discover new ways to     understand cancers and potentially predict the best treatments for patients with cancer in     the future.   "
85821|NCT02162680|"     The purpose of this study is to compare how well different anesthetic, or numbing, solutions     injected under the skin work in reducing the discomfort associated with placing a catheter in     a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been     found to be effective in reducing discomfort when injected under the skin just prior to     inserting the catheter. This study compares these two solutions, and will compare the     discomfort that occurs both with and without using these solutions.   "
85822|NCT02162667|"     This study will determine whether CT-P6 and Herceptin are equivalent in patients with     early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the     pathologic complete response rate will be equivalent in patients treated with neoadjuvant     CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to     10 cycles of therapy in the adjuvant setting.   "
91227|NCT02091986|"     The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and     Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in     Children Ages 6 to <12 Years with Asthma during 12 weeks.   "
85823|NCT02162654|"     The RIPAT study is a prospective, randomized, double-blind study organized by the     neurovascular group of the Clinical Department of Neurosurgery of Innsbruck Medical     University, Innsbruck, Austria. Patients aged 18+ in whom the treatment of an un-ruptured     intracranial aneurysm is indicated are eligible for study participation. Prior to aneurysm     treatment, with the patient already under general anesthesia, the blood supply to an arm will     be restricted for 3x 5minutes by inflating a standard blood pressure cuff. The study     hypothesis is that this remote ischemic preconditioning maneuver is able to prevent a     stroke during the following treatment of the aneurysm.   "
85824|NCT02162641|"     The purpose of this study is assess the technical and operational feasibility of a     specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal     cancer.   "
85825|NCT02162628|"     The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair     System for treatment of pelvic organ prolapse to traditional native tissue repair through 36     months of follow-up.   "
85826|NCT02162615|"     The purpose of this study is to collect information on the safety and effectiveness of     Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results     will be compared to the safety and effectiveness results in patients who have native tissue     repair (without mesh) as their pelvic organ prolapse treatment.   "
85827|NCT02162602|"     Compromised bone strength and increased fracture susceptibility pose significant morbidity     and health care costs in children. Inadequate childhood bone accretion also may have lifelong     consequences. Bone fragility among children with chronic medical conditions is a special     concern. Identifying children at-risk for bone fragility and factors affecting bone strength     requires understanding normal bone development. Dual energy x-ray absorptiometry (DXA) is the     most common method for measuring bone mineral content and bone density in children. There are     bone density reference data for children ages 5-20 years. An important gap is the lack of     reference data for children ages < 5 years, who also experience numerous medical conditions     that threaten their bone health.      Growth and body composition influence bone mineral accrual, and are important for     interpreting bone density measurements in children with conditions that threaten bone health.     Gross motor skills and subsequent physical activity may also affect bone accrual. Children     with chronic illness are at risk of altered body composition, delayed growth and gross motor     skills, and restricted physical activity. Understanding independent effects of growth, body     composition, gross motor skills and physical activity on bone accrual will improve     interpretation of bone density measurements and has important research and clinical     applications for identifying risk factors and therapies for young children.      This study will involve a longitudinal cohort of 280 children studied every 6 months for 3     years, and a cross-sectional cohort of 240 children measured once. The study will be     conducted at 2 clinical centers [Cincinnati Children's Hospital Medical Center (CCHMC) and     the Children's Hospital of Philadelphia (CHOP)] with equal enrollment at both centers.     Measurements will include bone density, growth and body composition, dietary intake, sleep,     physical activity and gross motor skills. Results from this study will enable clinical bone     health assessment of young children with disorders that threaten bone health, and identify     factors that affect bone accrual.   "
85828|NCT02162589|"     Prospective Multicenter registry study to assess the safety and efficacy of clinically     indicated peroral endoscopic myotomy (POEM) for the treatment of Achalasia   "
85829|NCT02162576|"     Propeller Health is collaborating with Walgreens Pharmacies, the City of Louisville, Qualcomm     Life and other local partners to carry out a focused demonstration project that will evaluate     the effectiveness of the Propeller Health approach to asthma management while exploring means     to use real-time data on asthma exacerbations in a public health setting. The Asthma Data     Innovation Demonstration Project (ADID) will use wireless sensor technology to develop     spatial and temporal data on the use of rescue inhalers by 300 study subjects with asthma in     the Louisville metropolitan area. Propeller Health will process these data to support two     general strategies.      Asthma self management: Rescue inhaler actuation data will be compiled into individualized     feedback reports to support asthma self management. Propeller Health will combine information     on individual rescue inhaler actuations with evidence-based asthma management tips into     real-time reports that will be provided to subjects. ADID staff will evaluate any resulting     improvements in asthma control that may be based on this information. Subjects may share     reports with their healthcare providers.      Municipal purposes: The second strategy is to provide aggregated and de-identified, spatial     and temporal asthma rescue inhaler actuation data to City personnel and authorized public     health researchers in Louisville. These data will show the times and locations of the use of     rescue inhalers by the 300 study subjects throughout the greater Louisville area. ADID staff     will work with City personnel and researchers to investigate how this unprecedented level of     detailed information on exacerbations can be used best to increase public awareness of     environmental triggers while supporting public health surveillance efforts around respiratory     diseases.   "
85830|NCT02162563|"     Colorectal cancer patients with initially unresectable liver-only metastases may be cured     after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal     neoadjuvant induction regimen has not been defined, and no consensus exist on criteria for     resectability.      In this study colorectal cancer patients with initially unresectable liver-only metastases,     as prospectively confirmed by an expert panel according to predefined criteria, will be     tested for RAS and BRAF tumor mutation status. Patients with RAS mutant tumors will be     randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab (schedule 1),     and triple chemotherapy (FOLFOXIRI) plus bevacizumab (schedule 2). Patients with RAS wildtype     tumors will be randomized between doublet chemotherapy (FOLFOX or FOLFIRI) plus either     bevacizumab (schedule 1) or panitumumab (schedule 3). Patient imaging will be reviewed for     resectability by a central panel, consisting of at least one radiologist and three surgeons     every assessment. Central panel review will be performed prior to randomization as well as     during treatment, as described in the protocol.   "
86903|NCT02148562|"     In this project proposal, the investigators will investigate the genetic alterations of     Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver     disease. Additionally, the investigators will compare and link these data sets with three     genetic factors involved in immune system response.   "
85831|NCT02162550|"     Investigators will be determining whether a once weekly injectable medication Bydureon versus     placebo is able to reduce the development of atherosclerosis.      Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will     improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis     plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies     will provide novel information about the temporal relationship between Bydureon induced     changes in risk factors, endothelial function and atherosclerosis progression.   "
85974|NCT02160678|"     To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference     listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to     demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in     the treatment of acne vulgaris.   "
85832|NCT02162537|"     The patients carrying a complicated primary lung cancer brain metastases die in less than 3     months of delay disease in the absence of treatment. The median survival of these patients is     approximately six months when the treatment associated with radiotherapy chemotherapy based     on cisplatin is now the standard treatment. In most studies the patients die of their brain     disease in one case only two, so it is likely that some patients do not require brain     irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for     patients in group B (without systematic irradiation) are not to suffer the side effects of     this radiation. The risks are in the same group to see brain metastases become symptomatic.      The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear:     should all patients be irradiated systematically (since the reference treatment is involved     and with the aim of obtaining better control of the brain lesions and maintaining a better     neurological status) or should only the patients showing cerebral progression be irradiated     (avoidance of possibly useless brain radiotherapy and its side effects). The aim of this     study is to better determine the position of cerebral radiotherapy in this context.      Main objective:      determine whether there is a difference in terms of progression-free survival between a     therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy     cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy     cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of     cerebral progression in patients with NSCLC with asymptomatic brain metastases   "
85833|NCT02162524|"     The primary purpose of this study is to quantify activation of regions of the brain     associated with appetite and reward after viewing high sugar and high fat (HS/HF) images     compared to control images following long-term aerobic exercise.        1. After long-term aerobic exercise compared to a no-exercise control group, viewing HS/HF          food images vs. control images will result in higher activation of regions of the brain          associate with appetite (hypothalamus).        2. After long-term aerobic exercise compared to a no-exercise control group consumption of          a sucrose solution compared to an artificially sweetened solution and a tasteless          solution, viewing HS/HF food images vs. control images will result in lower activation          of regions of the brain associated with reward [amygdala, anterior cingulate cortex          (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA), striatum, insula]          in overweight and obese men and women.      Exploratory Aims As exploratory aims, investigators will test a preliminary brain     connectivity analysis.   "
85834|NCT02162511|"     The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic     cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS system     is currently approved for use in patients who have AML, and a genetically matched sibling     donor. Through this protocol, the investigators will be able to offer potentially life-saving     transplants to patients who have genetically mis-matched donor, who have no other options for     treatment.   "
85835|NCT02162498|"     The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or treatment     to mothers or infants during the breastfeeding period indicate a paradigm shift in prevention     of mother-to-child transmission (PMTCT); care; and treatment programming. Yet despite South     Africa's adoption of this guidance, myriad challenges currently exist. Confusion in the     public health care system related to mixed messaging around safe infant feeding and the     provision of—and now withdrawal of—free formula milk have made adherence to exclusive     breastfeeding a challenge in South Africa. Cultural, social, and psychological factors     influence the ability of women to follow PMTCT guidelines, which include exclusive     breastfeeding for six months, adherence to ARV prophylaxis or treatment, and early infant     diagnosis. Facility-based interventions alone are often inadequate to effect sustained     behavioral changes in the face of multiple contextual factors. Community- and home-based     support are needed, yet cost and systems constraints make these infeasible in many PMTCT     programs. Some preliminary pilot data suggests that a feeding buddy strategy could fill this     gap and provide a home-based support system for the mother. The feeding buddy, who is     selected by an HIV-positive pregnant woman to support her in overcoming sociocultural     challenges to adhering to various aspects of PMTCT programs, is not an employed health care     worker, but rather an individual known to the mother, making the intervention extremely     cost-effective, and requiring minimal resources to implement. In the Uthungulu District of     KZN the Programme for Appropriate Technologies in Health (PATH) is implementing a programme     (Window of Opportunity-WinOp) of improving health of mothers and infants, and the feeding     buddy strategy is one of the strategies included in this overall package of care. While this     strategy has been encouraged by the South African Department of Health, it has not previously     been implemented nor obviously evaluated. In order to scale-up such a programme and justify     the human resource costs, it is vital that such a programme be evaluated.      The goal of this proposed research study is therefore to evaluate the effect of the feeding     buddy strategy to support mothers to adhere to PMTCT recommendations.      The investigators hypothesize that mothers who choose a feeding buddy will have increased     rates of exclusive breastfeeding and adherence to ARV prophylaxis or treatment, as well as     improved rates of early infant diagnosis and stigma reduction.      This evaluation will provide valuable information to the Department of Health in terms of     choosing best practice models for promoting HIV-free infant survival and optimum health of     infants in resource limited settings. The project plans to employ a cluster randomized     intervention design and will include 300 mothers and their infants as well as the 300 buddies     in the intervention group, as well as 300 mothers in the control group. All participants will     be part of the WinOp feeding buddy intervention programme.   "
85836|NCT02162485|"     The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler     with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream   "
85837|NCT02162472|"     The aim of this study is to determine if videocapillaroscopy could be used as an objective     and reliable method to assess psoriasis severity and to document improvement during treatment     by measuring changes in vascular features.   "
85838|NCT02162459|"     This study investigates the strength gains associated with resistance training in a group of     18 male high school athletes consuming either a whey protein supplement or chocolate milk     following their exercise.   "
85839|NCT02162446|"     The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for     the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).   "
85840|NCT02162433|"     The investigators aim to investigate the effect of dexmedetomidine on the perioperative     respiratory complications in this patient population undergoing both awake and deep tracheal     extubation.   "
85841|NCT02162420|"     Fludarabine-based preparative regimen followed by an allogeneic hematopoietic stem cell     transplant using related or unrelated donor in persons 0-70 years of age diagnosed with     dyskeratosis congenita or severe aplastic anemia who have bone marrow failure characterized     by a requirement for red blood cell and platelet transfusions. Three different preparative     regimens are included based on disease and donor type.   "
85842|NCT02162407|"     This study is conducted in Europe. The aim of this study is to estimate the relationship     between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous     (i.v.) administration of insulin detemir and human soluble insulin.   "
85843|NCT02162394|"     The investigators are conducting a prospective, observational study to examine the ECG     waveforms captured by the new medical device as compared to a traditional Holter monitor for     subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac     impulse and/or conduction disorders by qualified clinicians.      The hypothesis is that this new medical device prototype is non-inferior to traditional     Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and     ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.   "
85844|NCT02162381|"     Study will include adults with abnormal visual fields. Half of them will be given either     methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as     controls. All Subjects will also have a complete eye examination, a short questionnaire and a     questionnaire to screen for attention deficit disorder. The investigators will compare the     visual field results between the 2 tests.   "
87128|NCT02145637|"     This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose     (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that     inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.   "
85846|NCT02162355|"     The purpose of this multiple ascending dose study is to characterize the safety,     tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of     once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in     Japanese healthy subjects.      Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects     of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once     daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs     Caucasian healthy subjects.   "
85847|NCT02162342|"     The subjet is sitting on a chair and in front of him an adjustable (height) table with a     glass of water. 17 passive reflective markers are placed on his upper extremities and torso.     The subject is requested to reach the glass (once with the right hand and then with the left     hand) and bring it to the mouth and drink. Then the subject put the glass back at the     starting position. This is performed twice for each hand. In the second part, the same trial     is repeated but muscle activity is recorded with surface electromyography.   "
85848|NCT02162329|"     The goal of this research study is to test Tibetan meditation as a therapy to teach cancer     patients to change their brain functioning and to improve quality of life. Researchers want     to compare the cancer patients' outcomes to people who have never had cancer.   "
85849|NCT02162316|"     This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication     therapy and Motilitone in Functional Dyspepsia   "
85850|NCT02162303|"     The purpose of this trial is to assess the effects of colchicine on vascular inflammation     measured by (FDG)-PET imaging in patients with atherosclerotic vascular disease. This effect     will also be measured by soluble plasma biomarkers. Finally, an optional pharmacogenomic     investigation will be performed to identify genetic biomarkers of patient response.   "
85851|NCT02162290|"     The research will study the differences between interval training and continuous training     among cardiac patients in a cardiac rehabilitation facility.      The main objectives are:        1. Functional capacity measures (VO2 max).        2. Cardiac risk factors        3. Quality of life assessments.      Study hypothesis:      Interval training will be more effective in improving functional capacity, cardiac risk     factors and quality of life, compared to continuous training.   "
85852|NCT02162277|"     The frequency of osteoporosis in Japan is increasing. Also, the frequency of     osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently     required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in     Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are     several problems in this issue from the medical site and the patient site. The aim of this     study is, from the patient site, to increase the motivation of postmenopausal women for     osteoporosis using osteoporotic diagnostic kit.   "
85853|NCT02162264|"     To investigate the factors that affect Aricept medication persistence rate and the safety and     efficacy in patients with Alzheimer's Disease in clinical practice   "
85854|NCT02162251|"     To investigate the safety and effectiveness about administration of both donepezil     hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical     practice.   "
85855|NCT02162238|"     Introduction: The prevalence of low serum zinc in children under 5 in East Seme, Kisumu is     73.5% and this is likely due at least in part to low bioavailable zinc from the local     cereal-based diet. Interventions that will increase zinc intake could prove useful in the     effort to control zinc deficiency. A potential strategy is to increase zinc intake through     enriched or fortified water. The Life Straw Family filter (LSF, Verstergaard Frandsen S.A,     Switzerland) is capable of purifying water and at the same time enriching it with zinc at a     variable concentration with mean delivery of approximately 1-4mg/L.      Aims of the study: The primary aim of this study will be to quantify in under 5 year old     children the contribution of the household LSF device to zinc intake and dietary zinc     bioavailability in participating households. Secondary objectives are; 1) to assess change in     serum zinc levels, growth, morbidity in the intervention group compared to control; 2) to     characterize composition of the intestinal flora of children in the intervention group     compared to control.      Study Design and Methods:      Consenting households from East Seme, Kisumu, Kenya will be randomly allocated to 2 treatment     arms in an effectiveness study (90 under-five's per treatment arm). Group one will receive     the LSF device with the zinc delivery system; group 2 will receive a LSF without the zinc     delivery system.      Zinc intake will be assessed in a subsample of the under 5 year old children enrolled in the     effectiveness trial (n=100). This will be estimated by 24 hr recalls administered on 2     non-consecutive days in the dry and wet season. Selected food samples will be collected for     direct analysis of zinc and phytic acid content, to supplement data from food composition     tables (FCT's). The dietary assessment data will be used to estimate the distribution of zinc     intakes in this age group and the EAR cut-off method will be used to estimate the proportion     at risk of inadequate intakes.      Data on water intake from the LSF device will be obtained by personal diaries and tally     counters. The Zn concentration of the filtered water will be measured weekly. Using these     data and the data from the dietary assessment, the contribution of the LSF zinc delivery to     the overall dietary zinc intake will be estimated.      The effectiveness study will be conducted as a 6-month double blind randomised trial with 3     assessment time points (baseline, midpoint and endpoint). Three ml (3ml) whole blood will be     collected from under 5 year old children enrolled in the households for determination of     serum zinc (SZn), C-reactive protein (CRP), Alpha-1- acid glycoprotein (AGP) and hemoglobin     (Hb). Stool samples will be collected from a subsample at baseline, midpoint and endpoint in     the intervention and control group to assess the composition of the gut microflora and gut     inflammation. Anthropometrics (weight and height) will be measured at baseline, midpoint and     endpoint of the study. Weekly active surveillance for incidence and severity of malaria,     diarrhea and other infectious diseases will be done by questionnaire.   "
85856|NCT02162225|"     The investigators hypothesize that increasing plasma nitrite using dietary nitrate will     improve platelet function and red cell deformability and decrease MCHC in patients with     sickle cell disease. The investigators will test this hypothesis through administration of     daily intake of beetroot juice (Unbeetable - Performance Drink) to patients with sickle cell     disease for 28 days. The investigators will evaluate the safety of daily beet root juice     intake in patients with sickle cell disease. In addition, the investigators will measure     MCHC, red cell deformability, and platelet function (activation and aggregation) in response     to daily intake of beet root juice in this patient population.   "
85857|NCT02162212|"     The primary goal of this project is to determine how advanced glycation end-product (AGEs)     accumulation and shoulder movement (humeral thoracic range of motion and activity count)     interact to contribute to shoulder limited joint mobility (LJM), pain and disability, and if     an intervention consisting of a tailored dose of stretching and active shoulder movement can     reduce these problems in people with diabetes mellitus (DM). The investigators will focus on     the following measures that span health domains; Skin intrinsic fluorescence to measure AGEs;     Ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of motion and     activity counts to measure shoulder movements; and the Disability of the Arm, Shoulder and     Hand (DASH) questionnaire to measure patient reported pain and disability. The investigators     will test the innovative hypothesis that metabolic and movement factors interact to cause     severe shoulder problems in people with DM and that an optimized shoulder movement     intervention can have an important impact on reducing the development of limited joint     mobility, pain and disability in this population.   "
85869|NCT02162043|"     This project aims to evaluate a self-administered screening test for glaucoma, the second     largest cause of blindness in the western world. New approaches to glaucoma screening are     needed because a significant number of patients first present to hospitals with     advanced-stage glaucoma and late presentation is associated with a much higher risk for     future blindness. This project will develop a new user-friendly visual field test that will     be made available through the internet for self-testing. It will conduct both hospital-based     and community-based clinical trials to establish benefits and costs of this new test.   "
85858|NCT02162199|"     The sponsor is trying to develop a medicine for infections that are not cured by regular     antibiotics. They have an experimental drug called Debio 1450 that may work. They need about     48 healthy adults to volunteer for this study.      This study looks at what the body does to the drug. It measures how the amount of drug in     blood and urine changes over time.      From the screening visit through the follow-up visit may be up to 40 days. Volunteers go to     the clinic in Baltimore for a screening visit. The study doctor chooses qualified volunteers     to participate or serve as alternates. Alternates might not actually complete the study     procedures.      The study doctor divides participants into groups of eight. Six receive Debio 1450 and 2     receive Placebo. The drug each participant receives is decided by chance - like flipping a     coin.      Eligible volunteers check into the clinic for testing and those chosen to participate remain     for a 5-day/ 4-night stay. The clinic serves standard meals, except when fasting is required.     Participants must stay at the clinic for the length of the study.      This study is a dose escalation study. That means that if no safety concerns come up a new     group starts. Each new group of eight participants receives more capsules.      The study product is contained in capsules. Each capsule contains either placebo or 40 mg     Debio 1450. After fasting overnight, the first two participants in the group receive their     capsules. One gets Debio 1450 and one gets Placebo. If these participants tolerate side     effects for 24 hours, the remaining six participants receive their assigned capsules.      The plan is to increase the dose for the next group. The study doctor reviews the     measurements collected from each group after three days. He may decide to repeat, increase,     or lower the dose or even stop the study. The most any participant receives is 800 mg in 20     capsules.   "
85859|NCT02162186|"     The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2     weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been     any movement or wear in the hip stem over the course of the study. The study will also record     clinical data on each patient using various functional tests and questionnaires at the same     intervals.   "
85860|NCT02162173|"     Background: Familial adenomatous polyposis (FAP) patients are at risk to develop     periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of     the lesion is generally required to identify the presence of adenoma. However, the risk of     tissue sampling from the ampulla is high and non-ampullary polyps are sometimes numerous,     therefore resecting all the lesions is time consuming. To support the PIVI (Preservation and     Incorporation of Valuable endoscopic Innovations) initiative, a real-time diagnosis with NPV≥     90% is required.      Objective: To evaluate the diagnostic values of duodenal adenoma by dual focus NBI (dNBI) and     probe-based confocal endomicroscopy (pCLE) in FAP patients.      Design: Diagnostic study.      Setting: Single tertiary-care referral center.      Patients: Twenty-six patients with previously diagnosed with FAP.      Intervention: Surveillance EGD with dNBI and pCLE. A real time adenoma reading was done by     two different endoscopists for each of the technique. Histology from the matched lesion was     used as the gold standard.      Main outcome measurements: Sensitivity, specificity, positive predictive value (PPV), and     accuracy. With the threshold for negative predictive value (NPV) ≥ 90%   "
85861|NCT02162160|"     Generate more information on the use of the Probiotic Intimate Crème regarding feeling of     dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora     and presence of coliform bacteria in respect to E. coli in the intimate area of women before     use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days after     (9-11 days) finished crème-usage.      The hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women     with use of a probiotic creme.   "
85862|NCT02162147|"     Patient safety is an internationally recognized health care priority. Canadian data suggests     that about 8% of adults admitted to hospital experience unintended harm (or 'adverse events')     from the health care provided during their hospital stay. On a national level, this     represents almost 25,000 preventable deaths among hospitalized adults each year. The     emergency department is recognized as a high-risk environment for adverse events but most     patient safety research is not specific to the emergency department. As well, the vast     majority of people treated in the emergency department are sent home after their visit; yet     safety research focuses primarily on people who are admitted to hospital. Finally, although     children have also been identified as particularly high risk for suffering adverse events,     very little research has been done on how often these events occur among children who visit     the emergency department. Our study will address this gap in our knowledge about patient     safety and provide important information on the frequency, severity and preventability of     adverse events occurring among children in the emergency department. This information will     help us to improve the safety of emergency department care for all Canadian children.   "
85863|NCT02162134|"     Laparoscopic cholecystectomy is now very common procedure to remove the gall bladder from     abdomen. After this procedure many patients suffer from the non functioning of intestine and     stomach which is very common after any abdominal surgery. Many efforts tried to reduce this     non functioning period or postoperative ileus but non of them was superior later on. The     investigators want to evaluate the role of chewing gum for reducing postoperative ileus. The     investigators hypothesis is that Chewing gum after laparoscopic cholecystectomy reduces     postoperative ileus and sugared preparations are more effective to reduce it.   "
85864|NCT02162121|"     Stimulating catheters have been introduced to reduce the incidence of secondary failure after     continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating     catheters is still controversial. The aim of this prospective, randomized, blinded study is     to detect if stimulating catheters improve postoperative compared with conventional     non-stimulating catheters.   "
85865|NCT02162095|"     Patients with chronic obstructive pulmonary disease suffer from significant cardiovascular     morbidity and mortality. This study wants to determine whether chronic obstructive pulmonary     disease might be a risk factor for coronary atherosclerosis and other cardiac markers     independent of conventional cardiovascular risk factors. The study is designed as a     retrospective matched case-control study with follow-up via telephone interview.   "
85866|NCT02162082|"     To evaluate the long-term results after recanalization of coronary chronic total occlusions.   "
85867|NCT02162069|"     To evaluate the long-term results after transcatheter aortic valve replacement   "
85868|NCT02162056|"     To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS)     system in patients with coronary artery disease   "
85906|NCT02161562|"     This trial will assess the efficacy of optimized re-treatment therapy with omalizumab (150mg     or 300mg) after relapse, in patients with Chronic Spontaneous Urticaria who were clinically     well-controlled following their first course of treatment with omalizumab (150mg or 300mg).      Will also assess the benefit of uptitrating to 300mg dose those patients who are not     well-controlled following their first course of treatment with omalizumab 150mg.   "
85872|NCT02162004|"     The potential of currently available diabetes technologies could be further exploited. The     investigators propose that sensor-augmented insulin pump therapy may be improved by     continuous correction, i.e. continuous evaluation of the need for correction boluses. In     practice, this is carried out by running the bolus calculator every 10 minutes. The glucose     sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator     will come to the result that no insulin is needed. However, when the blood glucose is above     the pre-set target value and a correction bolus is needed, an appropriate bolus is     automatically delivered by the insulin pump.      The investigators hypothesize that sensor-augmented continuous correction insulin pump     therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with     type 1 diabetes.   "
85873|NCT02161991|"     Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention     of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up     to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell     lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence     aprepitant plasma concentration, which may lead to the individual difference of CINV control     rate.   "
85874|NCT02161978|"     project is a pilot prospective, longitudinal, before-after, open label multicentric study.   "
85875|NCT02161965|"     The VICTORIA Study (Vascular CalcIfiCation and sTiffness induced by ORal antIcoAgulation) is     a comparative, parallel, prospective, controlled and randomized study of the structural and     functional impact of rivaroxaban versus anti-vitamin K drugs on the arterial vasculature.   "
85876|NCT02161952|"     The aim of this study was to assess whether two-year treatment with Pirfenidone influence     necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.   "
85877|NCT02161939|"     The primary objective of this program is to provide DCV for 24 weeks to be given in     combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or     post-liver transplant subjects with chronic hepatitis C recurrence with either advanced     fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately     life-threatening condition or experienced an event that has decreased their life expectancy     to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are     defined. However, safety data will be collected throughout the study as well as efficacy data   "
85878|NCT02161926|"     The prevalence of obesity is growing in elderly with heavy consequences in term of medical     complications and mortality, so that this is nowadays an important public health issue.      The major therapeutic solution is dietary restrictions, but and the advantages and the     metabolic consequences are not well known in elderly. The MONA study main aim is to assess     the metabolic changes in this population, after dietary restrictions, compared to young     people.   "
85879|NCT02161913|"     Each year over 12,000 spinal cord injuries (SCI) occur in the United States. These injuries     result in incredibly difficult, long-term, life adjustments both for patients and their     caregivers. Many families continue to struggle with the physical, emotional and social     impacts of SCI for months and years after the injury. Family education and support improves     the outcomes of other challenging long-term conditions such as Traumatic Brain Injury, but     little effort has been made to provide such interventions for persons with SCI and their     caregivers. The proposed study will address this problem by refining and testing a group     treatment for SCI called Multi-family Group (MFG) intervention. The groups will include     people with SCI and their primary caregivers, and will be facilitated by an educator who is     a health care provider who works with people with SCI. By providing education about the     management of SCI and support in an MFG format, quality of life for persons with SCI is     predicted to be improved. In turn, it is expected that caregivers will also benefit from the     information, problem-solving activities, and social support that they receive from the     educators and other group members. The investigators will recruit 32 individuals with SCI who     have been discharged from inpatient rehabilitation within the previous three years and their     primary caregivers. Participants will be randomized to the MFG intervention or to an     education control condition and tested before and after treatment and 6 months following     treatment. It is hypothesized that participants receiving MFG-SCI will have better outcomes     than controls on measures of quality of life, health, and adjustment. The study will also     test whether participants who are more recently discharged from inpatient rehabilitation will     experience greater benefit from the MFG intervention or the education control intervention.     If the outcomes support the hypotheses, the MFG intervention should be made available to     those with SCI and their caregivers.   "
85880|NCT02161900|"     TITLE: Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment     for Breast Cancer      Yoga and Quality of life:      Yoga is based on the practice of physical postures, breathing techniques and meditation.     Philosophically, it aims at increasing the body's ability to master the mind with the goal of     spiritual awareness and connection. A randomized trial of yoga in women with breast cancer     undergoing radiation therapy demonstrated an improvement in impact of events scale at 3     months suggesting that the more intrusive thoughts at 1 month the greater the finding of     meaning in cancer by 3 months. Randomized studies have demonstrated evidence of yoga     improving the emotional well being of women with breast cancer and improving their distressed     mood, thus providing a buffering effect on QOL. The main beneficial effects demonstrated are     on social functioning. Among patients not receiving chemotherapy, yoga appears to enhance     emotional well-being and mood and may serve to buffer deterioration in both overall and     specific domains of QOL.      EVALUATION TOOLS- European Organisation for Research and Treatment of Cancer-Quality of Life     Questionnaire (EORTC QLQ-C30 & BR-23) Brief Fatigue Inventory VAS (Pain score) Spirituality     Questionnaire Pulmonary function test Objective assessment      STUDY ENDPOINTS- Primary end points- Disease free survival Secondary end points- Quality of     life & Improvements in overall survival      STUDY DESIGN TREATMENT PLAN - All newly diagnosed cases with stage I-III of breast cancer who     present to Tata Memorial Hospital will be randomly assigned to perform either a set of 'Yogic     and Routine Exercises (referred to as exercise I) or Routine Exercises'(referred to as     exercise II)./ Patients will begin the exercises within a week of starting treatment.      Both arms of the study will receive a training session one hour per day for the first week,     during which they will be instructed to practice daily and maintain a daily log. The other     evaluation tools will be used as per the assessment time line (enclosed).The exercises in the     Exercise I arm (Yoga and conventional exercises) will be upgraded within the next 2 days to     Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I     and II. Patients will be assessed at 6 months for compliance to phase II exercises. Only if     patients are fulfilling the criteria for accuracy, sequence and duration of phase II     exercises, will they be taught phase III exercises. Patients who are unable to do phase II     exercises at 6 months will be re taught phase II exercises. These patients will then be re     assessed at 1 year for up gradation to phase III. Six months after completion of phase III     exercises, patients will be assessed for compliance to phase III exercises. Patients will     also undergo an objective assessment at 1 year. An additional up gradation will be after     completion of adjuvant therapy at 6 months.      Patients will be followed up for a period of 5 years. DFS will be measured from the time of     randomization to either progression or death. Quality of life will be measured at baseline     and every six monthly using the functional assessment cancer therapy- quality of life.     Quality of Life analysis at 400 patients will be performed with appropriate correction for     multiple analyses applied.      STATISTICAL ANALYSIS- For an expected 50% 5 year disease free survival (DFS) for the control     group, the expected 5 years DFS for the intervention group will be 60%. With a two-sided     analysis, and at 80% power and 95% confidence to detect a 10% difference between the arms,     the sample size would be 761 patients. Assuming a 10% loss to follow up, a total of 850     patients would be accrued. We expect to complete accrual in 3 year.      RANDOMIZATION AND STRATIFICATION- Randomization for intervention will be done centrally from     Clinical Research Secretariat and patient will be stratified by      Menopausal status: Pre + Peri or Post Neoadjuvant or adjuvant treatment Stage of disease:     I/II/III ANALYSIS- Disease Free Survival (DFS) will be calculated from the date of     randomization to the date of local, regional or distant relapse or death from any cause and     will be censored at the last date of follow up for the patients that are alive and disease     free or have been lost to follow up.      Overall Survival (OS) will be calculated from the date of randomization to the date of death     or censored at the date of last follow up for the patients who are alive or lost to follow     up. DFS and OS will be evaluated using Kaplan Meier and compared by Log-rank test. The Cox     proportional hazard model will be used to assess the impact of intervention after correction     for stratification, menopausal status and age.   "
85881|NCT02161887|"     The overall objective of this study is to develop and test an efficient set of self-report     instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual     factors important in healing. The initial phase of the study involves developing and refining     an item bank. During the initial 'item bank development' phase, the investigators will run     focus groups and cognitive interviews with individuals who participate in CAM and     conventional medicine interventions. The next step of instrument development is called     Calibration, and involves administering the revised item bank to an internet sample and to     persons who receive services in a CAM clinic and a conventional primary care setting. The     items will be calibrated using item response theory and classical test theory. This will     result in a computerized adaptive testing version of the instrument, as well as a static     short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to     the final, Validation Phase of the study. The final phase of the project will involve     conducting initial validation studies of the set of instruments. The set of instruments will     be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate     the convergent, discriminant, and predictive validity of the HEAL instruments in a sample of     200 persons with chronic low back pain or neck pain who are receiving physical therapy,     chiropractic care, acupuncture, medical management, or mindfulness-based stress reduction.     For convergent validity, the HEAL is expected to display moderate to large correlations with     measures of similar constructs. The HEAL is expected to correlate modestly with self-report     measures of general psychosocial functioning, in support of discriminant validity. Finally,     HEAL scores should account for a significant proportion of the variance in treatment outcome,     supporting predictive validity.   "
85883|NCT02161861|"     cFEE peptide improves the IVF fertilization rate in mouse and fertilization index in human.     It improves sperm movement's parameters.      It has been studied over 3 generations of mice and appears without any side effects. The     Agence de la BioMédecine has given the authorization for testing the peptide in human IVF.      It is expected to improve the fertilization rate, and thus provide more embryos per IVF     attempt.      160 couples will be included over 15 months. Patient sperm parameters should be suitable for     IVF. Female should be between 18 and 43 year old. Each cohort of eggs will be randomly     distributed to one of the 2 groups The first group will be inseminated with 105/ml motile     spermatozoa. The second will be similarly inseminated but in a middle which will be     supplemented with cFEE 100µM.      Criteria: number of embryos in each group   "
85884|NCT02161848|"     The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag     muscles, thighs and calves in patients with the mitochondrial disease chronic progressive     external ophthalmoplegia (CPEO).      Additionally an investigation of the volume of the eye muscles will be done and compared to     the patient's clinical presentation of ptosis and ophthalmoplegia.   "
85885|NCT02161835|"     Investigators aimed to investigate whether training can increase fitness levels in patients     with myotonia, and thereby reduce the symptom of myotonia.   "
85887|NCT02161809|"     The investigators long-term goal is to increase the number of Summer Day Camps (SDC) that     meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA)     Standards. The objective is to evaluate the effectiveness of a multi-component intervention     designed to increase children's PA levels and improve the quality of lunches and snacks     children consume in SDCs. The HEPA intervention is designed to target children, parents,     staff, program leaders, and the SDC environment and uses a train-the-trainer model with SDC     leaders to train their staff to deliver and integrate the intervention into routine practice.     In the proposed study, the investigators will evaluate these HEPA strategies, using a 4-year     randomized controlled trial with 20 SDCs. An important feature of the study will be the     evaluation of maintenance of the intervention after the removal of research support (e.g.,     training, boosters) during the final year, as well as costs associated with implementation.      The investigators hypothesize that intervention SDCs will achieve significantly greater     increases in HEPA, compared to control SDCs. The investigators expect the study to support     the cost-effectiveness and maintenance of our strategies for promoting HEPA that will     facilitate SDCs meeting newly-established HEPA standards for this setting.   "
85888|NCT02161796|"     This study evaluates the concentration of FG-4592 in the blood over a certain period after     the intake of different doses, and assesses the effects, the safety and the tolerability of     the study drug in healthy young and elderly male and female subjects.      On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a     placebo, depending on the treatment sequence to which they are randomized. For each period     the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all     assessments are completed on Day 4 of each period, and return for an End of Study visit (ESV)     between 5 and 9 days after the last assessment of Period 4.   "
85889|NCT02161783|"     This is a guideline for the treatment of graft failure after hematopoietic stem cell     transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose     total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial     graft failure.      The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a     haploidentical related donor. The source of stem cells will be determined by the transplant     team based on factors such as patient's age, medical history, donor availability and will be     according to the current University of Minnesota Blood and Marrow Transplantation Program     selection guidelines.   "
85890|NCT02161770|"     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the     pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment     compared to patients with normal hepatic function; Part B will allow any patient with mild or     moderate hepatic impairment or normal hepatic function, who completes Part A, continued     access to AZD9291 after the PK phase and will provide additional safety data.   "
85891|NCT02161757|"     A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3     Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with     Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist   "
85892|NCT02161744|"     The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose     derived stem cells (aADSC) administered intravenously in patients with chronic obstructive     pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung     function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control     baseline of 6 weeks.      Patients will be followed up for 12 months after the therapy.   "
85893|NCT02161731|"     All study participants will receive both warfarin and a study drug called evacetrapib. The     main purpose of this study is to look at how much warfarin gets into the blood stream and how     long it takes the body to get rid of warfarin when given both with and without evacetrapib.     Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots     when given with evacetrapib by measuring the time it takes for blood to clot and comparing it     to an average of the international normalized ratio (INR). INR measures the time it takes for     blood to clot and compares it to an average.      The study will last approximately 5 weeks, not including screening.   "
85894|NCT02161718|"     This double-blind, randomized study will evaluate the efficacy, safety and tolerability of     ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).   "
85907|NCT02161549|"     Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby     integrating colon cleansing, screening and treatment into one procedure.      The device creates turbulence within the colon using water jets. The colon's fecal fluids are     evacuated by the system.   "
85908|NCT02161536|"     The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.   "
85895|NCT02161705|"     Primary Objective To determine if post-operative static pain scores differ between women     undergoing bilateral mastectomy followed by bilateral immediate tissue expander     reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo)     pre-operatively placed paravertebral blocks.      Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of     surgery while the patient is still hospitalized (post-operative day 0). This will be     patient-provided data. Unblinded data analysis will compare scores between treatment and     control groups.      Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea,     and sleep interference differ between women undergoing bilateral mastectomy followed by     bilateral immediate tissue expander reconstruction randomized either to ropivacaine-     (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.      Pain score, opioids use, nausea, and sleep interference data will be collected via patient     self-report. When possible (i.e., while hospitalized) objective data on opioids and other     pain medication administered to the patient will be used.      Tertiary Objectives To determine if long-term changes in Quality of Life scores [the RAND-36     Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and     Breast-Q scores] differ between women undergoing bilateral mastectomy followed by bilateral     immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or     saline- (placebo) pre-operatively placed paravertebral blocks.      This data will be collected via validated questionnaires through patient interviews at     3-months, 2-years, and 4-years (±14 days) after surgery.      Once enrolled in the study, participants will be encouraged to remain in the study for the 4     years following surgery in order to get final pain scores and quality-of-life/health outcome     survey information. Participants who cannot be contacted after several phone attempts and the     sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year     outcome assessments will be considered lost to follow-up.   "
85896|NCT02161692|"     The purpose of this study is to determine whether the use of a sequential high dose     chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide,     and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.   "
85975|NCT02160665|"     The purpose of this study is to compare the safety and efficacy profiles of Tazarotene Cream,     0.05% and Tazorac® (Tazarotene) Cream, 0.05% in order to demonstrate bioequivalence and to     demonstrate the superiority of the 2 active creams over that of the Vehicle (placebo) in the     treatment of plaque psoriasis.   "
85897|NCT02161679|"     This is a Phase II, open-label study that evaluates the safety and efficacy of IMMU-132 alone     and in combination with carboplatin in patients with triple-negative breast cancer. IMMU132     will be administered once-weekly for the first 2 weeks of 3-week treatment cycles. For those     patients assigned to also receive carboplatin, will receive it on the same schedules starting     30 minutes after the completion of IMMU-132 administration. Patients may receive up to a     maximum total of 8 cycles.   "
85898|NCT02161666|"     To examine pancreatic islet function and incretin function during intravenous and oral     stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance.     We hypothesize that islet cell and incretin function is enhanced in response to oral, but not     intravenous, stimulation - i.e. incretin released from the gut in response to oral     stimulation play a key role for the enhanced islet function after gastric bypass surgery.   "
85899|NCT02161653|"     The purpose of this study is to determine whether metadoxine is effective for improve     survival and reduced oxidative stress in patients with severe alcoholic hepatitis.   "
85900|NCT02161640|"     Inflammatory Bowel Diseases (IBD) is a group of relapsing and remitting gut inflammatory     conditions acquired due to genetic susceptibility and/or environmental triggers. The disease     manifestations are being increasingly seen in young children and the life-long debilitation     has a severe effect on quality of life. Limited evidence suggests, although rare, in some     young IBD individuals vascular complications may ensue. This leads to increased risk of     vascular problems such as thrombosis, arterial disease and stroke.      In the present project we aim to study and highlight potential vascular changes in young     Inflammatory Bowel Disease (IBD) patients and compare these changes with age and gender     matched controls. Vasculature will be measured in multiple ways including blood analysis in     the laboratory and non-invasive, physiological measures of arterial health (e.g. ultrasound     arterial scan). Our overall goal is to identify biomarkers indicative of increased risk of     vascular dysfunction as this will open new avenues for early therapeutic intervention.   "
85901|NCT02161627|"     The aims of the study are to compare automatic control of spinal cord stimulation with manual     control in patients with chronic pain of the trunk and limbs   "
85902|NCT02161614|"     The aim of this study is to evaluate the vascular effects of estradiol valerate on     climacteric women measured by flow-mediated evaluation of the brachial artery using high     resolution ultrasound and compare to placebo.   "
85903|NCT02161601|"     During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the     cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content     into the pharynx. This maneuver is called cricoid pressure.      Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid     cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid     pressure has not been investigated. In this study we have used high-resolution manometry     (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure     (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the     thyroid cartilage and against the trachea) during a rapid sequence induction.   "
85904|NCT02161588|"     This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics     (the exposure of the trial drug in the body), pharmacodynamics (the effect of the     investigated drug on the body), safety and tolerability of oral semaglutide in healthy male     Japanese and Caucasian subjects.   "
85905|NCT02161575|"     AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and     blindness registration in the UK . It is a disease which affects the retina (the nerve and     blood vessel network at the back of the eye responsible for vision). Patients can suffer with     severe visual loss and have difficulties with every day tasks such as recognising faces,     reading & driving.      There are two variations of the disease, a 'dry' type & a 'wet' type also known as     neovascular AMD (nAMD). In wet/nAMD new vessels grow from the blood supply underneath the     retina, in part due to higher than normal levels of a protein called Vascular Endothelial     Growth Factor (VEGF). Since the introduction of drugs which block VEGF, visual outcomes for     patients with wAMD have dramatically improved.      There are 2 widely used treatments; ranibizumab and aflibercept. Whilst the majority of     patients have a successful outcome with treatment, many patients experience suboptimal     response. This study will evaluate if these patients experience a benefit from a switch to a     different antiVEGF drug treatment. In this study nAMD patients who are showing no or poor to     response to treatment with aflibercept will be switched to ranibizumab to assess if there is     any benefit in terms of treatment outcomes.      Patients will visit the hospital clinic 8 times over the 7 - 8 month study period. Monthly     ranibizumab injections will be given for the first 3 months, then monthly as required for the     next 3 months. 162 patients will be treated in around 33 centres in Europe, of which     approximately 127 patients will be included in the UK   "
86966|NCT02147743|"     This randomized controlled study tests an innovative juvenile diversion model that integrates     evidence-based family therapy.Immediate and longer term effects of the family intervention     will be compared to Services As Usual with 120 adolescents participating in Miami-Dade's     Civil Citation Program.   "
85936|NCT02161172|"     Patients with traumatic brain injury are likely to present with cognitive, psychological,     emotional and behavioral problems during different periods, all of which affect patients'     life quality seriously. The aim of this study was to assess cognitive and psychosocial     outcome in patients with mild traumatic brain injury, and to determine the risk factors     associated with cognitive and psychological outcome. Mini-mental state examination (MMSE),     activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and     mental health symptom checklist (SCL-90) were used to assess the cognitive performance and     psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's     exact tests and Logistic regression analysis were used to analyze the risk factors.   "
85937|NCT02161159|"     This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in     patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms     have not been adequately managed by oral anticholinergic therapy.   "
85938|NCT02161146|"     This study will evaluate the safety and efficacy of AGN-229666 for the prevention of     allergen-mediated conjunctivitis.   "
85976|NCT02160652|"     A single center single arm prospective study, assessing the outcome of ureteral     re-implantation for malignant ureteral obstruction.   "
85909|NCT02161523|"     In addition to their role in allergic inflammation, mast cells are often found at the site of     tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on the     tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast growth     factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8) can     enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors.      The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung     cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis.      In this work, we are interested to determine the factors in lung cancer microenvironment that     attribute to mast cell activation. Beside the tumor cells themselves, the cancer     microenvironment includes other cells such as fibroblasts. The fibroblasts arising from tumor     stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have different     feature compared to normal fibroblasts (NFs). In this work we are interested to determine     whether CAF cells derived from lung tumors, together with the lung cancer cells, or     microvesicles-derived from these cells, are able to stimulate mast cells to degranulate and/     or to release various cytokines and chemokines.      For this propose, during surgery of patients with lung cancer, we will take unnecessary     sample from the cancer and from normal area for purification of CAF or normal fibroblast     cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or     microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will be     collected for determine degranulation and cytokine release from these mast cells.   "
85910|NCT02161510|"     The objective of this study is to identify a safe dose of MK-2248 in participants with     Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from     baseline. It is anticipated that once-daily administration of a safe and well tolerated dose     of MK-2248 will reduce VL by at least 3 log10 IU/mL.   "
85911|NCT02161497|"     The investigators are studying the difference between the history taken from parents prior to     their child's anesthesia to information gleaned routinely from a patient information system     called Ofek.   "
85912|NCT02161484|"     The purpose of this research study is to evaluate the analgesic efficacy of adding a single     shot parasacral (sciatic) nerve block to a continuous lumbar plexus block in patients     undergoing total hip replacement.   "
85913|NCT02161471|"     The purpose of this study is to determine whether patients with repaired congenital heart     disease show differences in size or function of their heart atria compared to normal controls     and depending on the nature of their heart disease.   "
85914|NCT02161458|"     Alzheimers disease (AD) is a devastating illness, estimated to affect 5 million patients in     the United States alone and projected to increase dramatically over the next decades as the     population ages unless preventive measures can be developed. The investigators have     preliminary evidence that selective serotonin reuptake inhibitor (SSRI) antidepressants lower     the amount of amyloid plaques in the human brain. The interventions now propose to study the     effects of an SSRI (escitalopram) on levels of amyloid beta peptide (the major constituent of     the plaques) in the cerebrospinal fluid (CSF) of cognitively normal older adults.   "
85915|NCT02161445|"     the gold standard for the diagnostic of acute heart failure is based on clinical, biological     (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is     difficult and requires further investigations.      BNP dosages and echocardiography are not always available in many medical centers, especially     in emergency departements, and are expensive.      we investigated the use of alternative methods, such as the systolic time intervals (STI), in     the diagnosis of acute heart failure (AHF) in emergency departement patients consulting for     dyspnea.   "
85916|NCT02161432|"     To determine the relative bioavailability of an BI 187004 tablet formulation compared to an     oral solution of BI 187004 and to assess the influence of food on the bioavailability of the     tablet formulation.   "
85917|NCT02161419|"     This is a study to investigate the potential clinical benefit of roniciclib when given in     combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line     treatment in patients with extensive disease small cell lung cancer. Approximately 140     patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in     combination with chemotherapy.      Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor     targets certain key proteins that are essential for the survival of the cancer cell. The     growth of the tumor may be decreased by preventing these specific proteins from functioning.     By specifically targeting these proteins, roniciclib in combination with chemotherapy may     stop cancer growth.      The primary endpoint (the most meaningful result to be tracked) of this study is based on the     progression free survival, i.e. the time the disease is not worsening. The aim is to show     that the therapy with roniciclib in combination with chemotherapy prolongs the time the     disease is not worsening in this patient population compared to patients receiving placebo in     combination with chemotherapy.   "
85918|NCT02161406|"     The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement     in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis     (dcScc) compared to matching placebo.   "
85934|NCT02161198|"     Y-75/ginsan is an acidic polysaccharide with a molecular weight of 150,000 Da, isolated from     the aqueous Korean Panax ginseng extract. Preclinical laboratory studies have shown its     function as an immunomodulatory molecule. The present study performed to evaluate the safety     and beneficial effects of Y-75 on immune function in a group of healthy adults.      The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of     natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear     phagocytes, and serum levels of monocyte-derived mediators.   "
85935|NCT02161185|"     The purpose of this study is to examine the long-term safety and tolerability of USL261 in     the treatment of seizure clusters.   "
85947|NCT02161029|"     The purpose of this study is to determine whether the newly constructed CE (Conformité     Européenne) marked drill biopsy instrument for flexible endoscopes can make possible     representative biopsies of the increasing numbers of submucosal tumours in the     gastrointestinal tract. The amount of submucous tissue ( micrograms and in % of all the     biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy     investigations is measured in the study and compared to the amount of submucous tissue     harvested with the existing biopsy forceps.   "
85919|NCT02161393|"     The primary aim of this study is to assess the feasibility of conducting a trial to     investigate the effectiveness of a physical activity intervention (physical activity     consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in     improving physical activity in COPD.      Objectives are:      (i) to assess the feasibility (patient recruitment, adherence, drop-outs and adverse events)     of delivering a physical activity intervention in the COPD patient population versus     pulmonary rehabilitation; (ii) to explore users perceptions relating to satisfaction and     benefits of a physical activity intervention versus pulmonary rehabilitation; (iii) to     investigate between and within group change in physical activity, exercise capacity, quality     of life, self-efficacy and changes in the transtheoretical model with the physical activity     intervention versus pulmonary rehabilitation; and (iv) to examine the cost of delivering a     physical activity intervention versus pulmonary rehabilitation for patients with COPD.      The hypothesis for this study is that it will be feasible to conduct a trial that will     investigate the effectiveness of a physical activity intervention (physical activity     consultation and a pedometer-based walking programme) compared to pulmonary rehabilitation     for improving physical activity in COPD. The study will provide important information about     interventions designed to promote and maintain physical activity, improve patient outcomes     and increase patients' choice relating to exercise and physical activity interventions. It     will provide a rationale and data for an adequately powered clinical trial evaluating the     effects of a physical activity intervention.   "
85920|NCT02161380|"     Hypotheses:      The primary hypothesis being tested is that there will be no toxicity resulting in loss of     vision to no light perception in injected eyes.   "
85921|NCT02161367|"     Post-operative ileus is a common complication following abdominal surgery. It results in     abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this     results in prolonged hospital stay and occasionally readmission following abdominal     surgery.The etiology of post-operative ileus is multifactorial and studies evaluating     potential treatment options are abundant, though few reliable interventions exist. This study     proposal describes a double-blinded randomized controlled trial investigating the effect of     simethicone on post-operative ileus in patients undergoing colorectal surgery.   "
85922|NCT02161354|"     To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third     molar extraction.   "
85923|NCT02161341|"     The ocular surface is the first line of defence of the eye, it is therefore where external     threats are sensed, and potential insults neutralised. Over the course of evolution, various     microbes, especially bacteriae, have come to colonise the ocular surface as commensals. The     commensals have a role to maintain the homeostasis of the ocular surface. 1 The innate     immunity of the ocular surface is very active, and consists of active mechanisms to suppress     inflammation 2. For example, there exist macrophages, dendritic cells, suppressor cells,     regulatory cells, B cells, IgA, lysozyme, anti-microbial peptides and barriers against     external agents. The normal commensals of the ocular surface maintain a basal level of     activation of innate defence by stimulating the pattern recognition receptors on ocular     surface epithelial cells. This normal composition of microbes is important since inflammation     and infection will result if there is introduction of a pathogenic strain that overcomes the     flora, or if a dominant strain secretes excessively immunogenic products, such as the     exotoxin A of Staphylococcus which triggers marginal keratitis, a form of type IV     hypersensitivity. The flora load of microbiome could also influence tear function as a higher     flora load was found to be associated with increased mucin degradation 3 and reduced globet     cell densitiy 4. Previous studies [I'm not sure which studies these are] at SERI/SNEC also     point to the importance of microbes. For example, in dry eye patients, there is increased     lysophospholipids in the tear, and this may contribute to inflammatory mediators such as     arachidonic acid and other metabolites. The lysophospholipids are formed by phospholipase A2     reactions, and the latter may be microbial in origin. Since dry eye is a known inflammatory     disease of the ocular surface, this is one way that microbes can contribute to the pathology.   "
85924|NCT02161328|"     The changes of local pulmonary ventilation should be registered with an electric impedance     tomography (EIT) before and after a dilatative tracheotomy. The hypothesis is that the EIT     cannot show changes in local ventilation due to the tracheotomy.   "
85925|NCT02161315|"     Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer     is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the     past controlled clinical trials with small sample.   "
85926|NCT02161302|"     The purpose of this study is to determine if transcranial direct current stimulation (tDCS)     is effective in the treatment of chronic pelvic pain associated with endometriosis   "
85927|NCT02161289|"     Objectives        1. To evaluate the acceptability and feasibility of standard HIV prevention package among          Thai men who have sex with men (MSM)        2. To conduct a pilot study to demonstrate the acceptability and feasibility of          internet-based social networking, asymptomatic sexually transmitted infection diagnosis          and treatment and pre-exposure prophylaxis strategies as potential HIV prevention          methods among Thai MSM        3. To use mathematical modeling to identify the most effective HIV prevention package          optimized for Thai MSM      Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic (TRC-AC),     age ≥18 years old,Each participant will have a 12-month follow-up duration in the study.   "
85928|NCT02161276|"     Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.      aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule     to treat type II diabetes mellitus.      ---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the     treatment of type II diabetes   "
85929|NCT02161263|"     The investigators are administering a validated questionnaire looking at patient reported     quality of life and quality of vision after LASIK surgery   "
85930|NCT02161250|"     Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise     in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily     digested carbohydrate).   "
85931|NCT02161237|"     Primary purpose of this study is to compare renal function between subjects receiving     optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving     standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf®     over 52 weeks after kidney transplantation will also be obtained.   "
85932|NCT02161224|"     The effect of moderately diminished liver function on the exposure, safety and tolerability     of a single dose of FG-4592 is studied in male and female subjects. The results are compared     to the data gained from subjects with normal liver function.   "
85933|NCT02161211|"     The purpose of this study is to establish a brief CBT intervention that can largely, if not     fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol     use disorder treatment outcomes.   "
85939|NCT02161133|"     There are almost 700,000 Gulf War Veterans (GWV) with 25-30% suffering from a devastating     multi-symptom illness coined Gulf War Illness (GWI). GWV with GWI report significant activity     limitations and chronic cognitive problems consistent with problem-solving deficits.     Problem-solving is considered the most complex of cognitive abilities and is what enables us     to conduct complicated behaviors such as setting goals, sequencing and multi-tasking. As a     result studies have found that problem-solving deficits are prospectively related to a     greater risk of disability. Despite published reports documenting these problems there are no     treatments that target the problem-solving deficits of GWI. This proposal seeks to determine     whether Problem-Solving Therapy, a patient centered cognitive rehabilitation therapy, can     reduce disability by compensating for problem-solving deficits.   "
85940|NCT02161120|"     The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-,     Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than     commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims     to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota     and hydrogen production during the test periods (a marker of large bowel fermentation of     poorly absorbed carbohydrates).   "
85941|NCT02161107|"     The purpose of this study is to determine whether it is safe to administer Grass-SPIRE to     subjects suffering from both grass allergy and asthma   "
85942|NCT02161094|"     Objectives:Physicians from the Shanghai Jiading community clinic were invited to attend the     study seminar. Those physicians who meet the criteria of the study plan were being selected     to participate voluntarily. From their patient's record, the physicians will recruit a total     of 1300 patients with type 2 diabetes who meet the criteria of the Jiading Study.      The study utilizes the social learning theory that motivation and social support are     important to make behavioral change. The mechanism of providing incentive for patients and     physicians will be established after the permission from the Internal Review Board of the     hospital and will be approved by the hospital director. Physicians and their patients were     randomly divided into 4 groups: Group 1- Physicians only; Group 2 - Patients only; Group 3 -     Both Physicians and Patients, Group 4 - control. Groups 1-3 will receive incentives if they     can maintain the ideal level of Hemoglobin A1c (HbA1c) during the 3-years study period. The     forth group serves as a control and will not receive any incentive but will be provided     diabetes education booklet and group education courses for DM control as usual. Based on the     annual evaluation of the level of improvement on HbA1c that is a joint effort of both     patients and physicians to achieve the targeted goal of adequate HBA1c level, the value of     incentives will be increased accordingly. Our ultimate goal is to evaluate the effectiveness     of incentive as an intervention tool to improve the health status of the diabetic patients.   "
85943|NCT02161081|"     Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most     advantageous in obtaining information on myocardial blood flow and volume. However, dynamic     CT perfusion technique involves higher radiation dose than static CT techniques. Patients     have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If     patients cannot hold their breath, anterior or inferior myocardium might be excluded due to     limited scan coverage of a 128-slice dual-source CT scanner.      Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation     exposure, but also make patients more comfortable. Therefore, the investigators intended to     propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy     of a modified scan protocol with the current scan protocol.   "
85944|NCT02161068|"     This is a retrospective analysis to include demographic, clinical, biochemical, and genetic     data that will further explore the natural history of ADPKD and assess the factors that are     likely to be associated with the progression of disease and the incidence of complications     including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular     disease.   "
85945|NCT02161055|"     An increase in blood glucose is a common clinical symptom in patients following traumatic     brain injury. Studies confirm that death after traumatic brain injury was not only associated     with nerve injury, but also correlated with abnormal physiological and metabolic reactions.     Hyperglycemia is a manifestation of physiological and metabolic disorders after traumatic     brain injury. Traumatic brain injury induced hyperglycemia, and then aggravated secondary     injury to the brain. Therefore, it is of important clinical significance to study the     treatment of hyperglycemia after traumatic brain injury.   "
85946|NCT02161042|"     Blood transfusion is often used to treat patients with Anemia. The period of storage of blood     products prior to use for transfusion may vary. Prolonged storage of blood products may     result in changing their biochemistry.      This study aims to look into whether the transfusion of old blood, which is stored for more     than 7 days, as compared to the transfusion of Fresh blood, which is stored for less than 7     days, will affect endothelial function.   "
85948|NCT02161016|"     This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle.     Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem     cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed     an informed consent, the baseline visit and examinations will be completed. Patients will be     evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.   "
85949|NCT02161003|"     The problem of the incontinence imposes considerable strain on the child and their parents.     These patients suffer from a long-life handicap and they need support and follow-up. The cost     associated with these diseases has clearly been illustrated to be a major component in the     healthcare spending picture, may be adding hundreds of thousands of dollars to healthcare     cost, as well as loss of productivity in the work force. Fecal incontinence treatment has     been a difficult challenge for surgeons for several generations until now the current     traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may represent     a new attractive treatment option for anal sphincter lesions. Moreover, experimental injury     of muscle of anal sphincter in rats has been successfully treated with stem cells injections.     In this study, the investigators will shed more light on the ability of Mesenchymal Stem     Cells to induce myogenesis and regenerate anal Sphincter of patients with fecal incontinence.     It will be very useful to many Egyptian patients.   "
91245|NCT02091752|"     The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after     treatment interruption due to loss of response and/or adverse events.   "
85951|NCT02160977|"     If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover     earlier, it will accelerate the regaining of motion control ability and motion control     accuracy of the TKA patients. This study compared the proprioception difference of the post     operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of     proprioception recovery were analyzed following the two different TKA procedures and the     advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.   "
85952|NCT02160964|"     Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have     been made in the filter design to resolve problems of structural integrity and increase the     ability to remove the filter after longer periods of time.The FDA issued a communication in     August 2010 advising physicians to remove retrievable filters whenever possible and updated     that letter again in May 2014 due to concerns that these retrievable IVC filters, intended     for short-term placement, are not always removed once a patient's risk for PE subsides. Known     long term risks associated with IVC filters include but are not limited to lower limb deep     vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC     perforation.   "
85953|NCT02160951|"     This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese     patients with relapsed and/or refractory multiple myeloma for which no standard effective     treatment options exist.      The study consists of a dose escalation part to estimate the maximum tolerated dose and/or     the recommended dose for expansion and a dose expansion part to further assess safety and     preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the     recommended dose for expansion.   "
85954|NCT02160938|"     The objectives of this multi-center collaborative study are to ascertain the frequency of     specific copy number variants (CNVs) identified prenatally and to evaluate in detail through     continued follow-up of the children the phenotypes associated with CNVs of known or uncertain     clinical significance.   "
85955|NCT02160925|"     The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging     for the diagnosis of renal oncocytomas.   "
85956|NCT02160912|"     In this observational study insights regarding the tolerability and influence on the quality     of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in     patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.      Patients are treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen according to the     demands of the physician and the instructions for use.   "
85957|NCT02160899|"     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     ISIS-APO(a)Rx given to patients with high lipoprotein(a) for 12 weeks.   "
85958|NCT02160886|"     A randomized trial investigating if effects of a goal-directed task oriented intervention is     influenced by who takes the decision and establishes the goal (the child or the parent) and     whether establishing a goal per se influence performance and goal-achievement. The main     hypothesis are that children's participation in the goal-setting process would positively     influence goal achievement, children's self-identified goals would be achievable and that     both groups would achieve goals that were the target of a goal-directed intervention.   "
85959|NCT02160873|"     The purpose of this study is to investigate the influence of a nighttime feeding on next     morning running performance, hydration status, and exercise metabolism in female endurance     athletes. Specifically, the effect of a chocolate milk beverage will be examined versus a     non-nutritive, flavor-matched placebo. The investigators hypothesize that the nighttime     consumption of chocolate milk, a whole food complex, will result in improved next morning     running performance versus placebo. Secondarily, the investigators hypothesize that any     potential positive performance outcomes from the chocolate milk treatment may be due to an     enhanced pre-exercise hydration status or improved exercise metabolism.   "
85960|NCT02160860|"     Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.   "
85961|NCT02160847|"     The purpose of this study is to help overweight or obese children to maintain or reduce their     body mass index (BMI) through the home-based parent training program the investigators     developed called DRIVE. The investigators hypothesize that children from families that     receive the DRIVE program will show greater maintenance or improvement in their BMIs than     families who do not receive DRIVE.   "
85962|NCT02160834|"     Greater time spent in sedentary behaviors, independent of physical activity level, can     increase risk of morbidity and mortality. Objective assessments indicate that bariatric     surgery patients spend large amounts of time in sedentary behaviors. The present study is the     first to test whether a mobile health (mHealth) approach that employs widely adopted     smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible     and acceptable method of reducing sedentary time in these patients and other obese     populations.   "
86144|NCT02158468|"     The LIPSIA-Conditioning trial is an investigater initiated, randomized, single-center study     that will assess the effect of different intrahospital conditioning protocols on myocardial     damage assessed by MRI in patients with acute ST-elevation myocardial infarction.      The following groups will be compared:        1. Combined intrahospital pre- plus postconditioning versus        2. Postconditioning versus        3. Control   "
85963|NCT02160821|"     Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional     anesthesia technique for providing postoperative lower abdominal analgesia. Complications     associated with TAPB are very rare and pose a lower overall risk to the patient receiving a     TAPB versus a caudal block, which is considered the gold standard for pediatric lower     abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to     caudal block initially in providing postoperative pain control but would show improved pain     relief beyond the anticipated caudal duration.   "
85977|NCT02160639|"     Improving diabetes social support is associated with health improvement benefits. This study     is a prospective randomized controlled trial comparing the effects of telephone-based     diabetes self-management support (DSMS) compared with usual care, which includes diabetes     self-management education (DSME), during a 1-year period. It will determine whether this     specific model for providing on-going support to people with diabetes will better enable them     to maintain the engagement in self-care behaviors, clinical improvements and     diabetes-specific knowledge gained during the course of diabetes self-management education.   "
85964|NCT02160808|"     Pancreatic leaks complicate pancreatic resection in approximately 20% of cases. The     pancreatic anastomosis or repair has been referred to as the Achilles heel of pancreatic     surgery. Unfortunately, despite recognition of this problem and multiple operative techniques     proposed to prevent this complication, leaks continue to represent a major cause of morbidity     for patients undergoing pancreatic surgery. Treatment of leaks often requires nutritional     support with total parenteral nutrition to diminish the leak in addition to invasive     interventions to contain the leak with drains, stents or in severe cases, reoperation.     Experiential data suggest that intra-operative infusions of secretin, a naturally occurring     hormone that stimulates bicarbonate release from the pancreas, following resection but just     prior to abdomen closure, may identify a leak if present. If secretin can demonstrate     evidence of leaking intra-operatively, the pancreatic duct leak may be able to be fixed prior     to abdominal closure. The investigators aim to determine if giving an intra-operative     infusion of secretin will allow for identification and treatment of leaks after pancreatic     reconstruction and prior to abdominal closure, leading to a reduction in the rate of     pancreatic anastomotic leaks requiring intervention. The investigators will perform a     double-blind, randomized pilot study of 176 patients undergoing pancreatic resection     (pancreaticoduodenectomy and distal pancreatectomy) at Dartmouth-Hitchcock Medical Center. 88     of those patients will receive an intra-operative secretin infusion prior to abdominal     closure and 88 will receive a saline placebo. Our primary outcome of interest will be the     rate of pancreas duct leaks in each group as measured by the amount of amylase present in the     surgical drains 5 days following surgery.   "
85965|NCT02160795|"     Background:      - Pregnant women are encouraged to take the vitamin folate. It helps prevent some birth     defects. Children of mothers who take it also have less risk of some cancers. Between 1993     and 1995, some women in China took the vitamin daily before and during early pregnancy.     Another group did not. This study will follow up on children born to both sets of women. (The     children were born between 1994 and 1996.) Researchers will use these data to study the link     between folate and cancer in infants and children.      Objective:      - To see if folate may reduce childhood cancer if women take it every day before and during     early pregnancy.      Eligibility:      - Mothers who took part in a Chinese folic acid study between 1993 and 1995 and their     offspring.      Design:      - Mothers of children in the study will sign a consent form. The form lets the researchers     review the child s medical history. They may also review data about their cancer diagnosis.     The children will also sign a form.   "
85966|NCT02160782|"     This is a long-term, open-label study with a double-blind, placebo-controlled, randomized     drug withdrawal period in children with ALGS designed to evaluate the safety and efficacy of     LUM001. The study is divided into 5 parts: a 6-week open-label, dose escalation period, a     12-week stable dosing period, a 4-week randomized, double-blind, placebo-controlled drug     withdrawal period, a 26-week long-term stable dosing period, and an optional 52 week     follow-up treatment period for eligible subjects who choose to stay on treatment with LUM001.     Subjects' participation in the optional follow-up treatment period will continue until the     first of the following occur: (i) completion of 52 weeks of additional treatment (Week 100),     or (ii) in the event that a new study of LUM001 opens to enrollment.   "
85967|NCT02160769|"     The investigators study aims to capture the objective effects of pterygium surgery on tear     layer lipid thickness and the tear layer.      Previous objective studies of the tear film has been limited to corneal staining grading,     tear break up time and Schirmer's test which have been shown to poor to moderate     repeatability. The effect of pterygiums on tear layer lipid thickness (LLT) has not     previously been explored. With the LipiView Ocular Surface Interferometer, the investigators     have the ability to assess the optical coherence interference pattern produced by light     reflected off the tear film in a safe and non-invasive manner. Software analysis of the image     then measures the tear LLT which can be used to objectively quantify the diagnosis of     lipid-deficient dry eye.   "
85968|NCT02160756|"     The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a     drug enters and leaves the blood and tissues over time) and relative bioavailability (the     extent to which a drug or other substance becomes available to the body) of JNJ-56021927,     when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule     formulation (reference) in healthy male participants under fasted conditions at a single dose     of 240 milligram (mg).   "
85969|NCT02160743|"     This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination     of CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg) in healthy male subjects   "
85970|NCT02160730|"     The investigators hypothesize that R-roscovitine will suppress pituitary corticotroph tumor     ACTH production and normalize urinary free cortisol levels in patients with Cushing disease.     To date, R-roscovitine has been evaluated in several Phase I and II studies and has shown     early signs of anti-cancer activity in approximately 240 patients.   "
85971|NCT02160717|"     Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome     have abnormalities in glucose metabolism which can lead to diabetes. The current screening     guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar     once a year. The objective of this study is to determine if there are abnormalities in     glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study     hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin)     is more prevalent in girls with Turner Syndrome compared to healthy controls.   "
86034|NCT02159898|"     This is a prospective, single blinded, randomized study of EndoMAXX EVT Fully Covered     Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus.     The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture     with EndoMAXX EVT Fully Covered Esophageal Stent with Valve (investigational device) compared     to the EndoMAXX Fully Covered Esophageal Stent (reference device).   "
85972|NCT02160704|"     This is an exploratory, single center, randomized, parallel, double-blind placebo- and     active-controlled trial in adult males ages 18 to 35 years of age who have male infertility     of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment     groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of     the men will receive a placebo (non-active pill) for 16 weeks. This study will last     approximately 4 months and involve up to 7 visits.      The purpose of this study is to determine the effect the Androxal on sperm production.   "
85981|NCT02160587|"     This is a safety study to determine the skin sensitization potential of ZuraPrep™ and     ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of     human subjects. Indications of both sensitization and skin irritation will be evaluated.   "
85982|NCT02160574|"     This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and     ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human     subjects.   "
85983|NCT02160561|"     Lower lobe atelectasis of the lung is common in Acute Respiratory Distress Syndrome (ARDS)     and has the potential to adversely impact lung compliance and intra-pulmonary shunt. The     cephalic shift of the diaphragm and dorsal atelectasis associated with the commonly used     supine position might also contribute to this shunt. Reports indicate that obese patients may     be more likely to develop dorsal atelectasis than non-obese patients.      The investigators hypothesized that opening the body position angle at the waist from a     typical head of bed at 30 degrees to one similar to a more upright reverse trendelenburg     position, would alter the position of the diaphragm downward, allowing for improved aeration     of lung bases. Thus, the investigators examined the upright body positioning in mechanically     ventilated patients with ARDS primarily by evaluating for effects on oxyhemoglobin saturation     (O2sat), Tidal Volume (TV) and Respiratory Rate (RR).   "
85984|NCT02160548|"     We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine     alone in OP poisoned patients. We propose to compare the effect of two stat doses of     nebulized salbutamol (2.5 mg; 5.0 mg), with nebulized saline placebo, in symptomatic patients     receiving standard resuscitation with atropine, oxygen, and fluids after poisoning with OP     pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary outcome     will be oxygen saturation's over the following 60 min during resuscitation. Secondary     outcomes will include atropine dose administered, speed to stabilization, aspiration or     pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome will result in     design of a large definitive phase III study.   "
85985|NCT02160535|"     This study will provide evidence on whether the use of an FDA-approved drug therapy for the     treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of     chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the     head, or a fall, or a motor vehicle accident, or some other traumatic event.   "
85986|NCT02160522|"     Our study will measure the pressure of the endotracheal tube cuff in intubated patients in     the emergency department.   "
85987|NCT02160509|"     1. Purpose             -  This study aims to evaluate the feasibility of iPhone based telementoring for the               ultrasonography.        2. Methods             -  Study Design: Prospective observational study             -  Study Setting: Urban academic ED of tertiary care teaching hospital             -  Study period: July, 2014 ~ December, 2014 (six months)             -  Study participants: Of the patients who need to undergo ultrasonography in the ED,               those who are agreed to participate in this study are enrolled.        3. We hypothesize that the iPhone based real time tele-diagnosis by remote expert would not          be different from the diagnosis via his/her direct ultrasound examination.   "
85998|NCT02160366|"     The goal of this laboratory research study is to collect and analyze treatment, molecular     profiling and biomarker data. The results of the data analysis will be used to better     understand how to characterize tumors and identify therapies that may be tailored to     individual patients and to identify and/or predict side effects that may occur and/or predict     which therapies may be best for participants. Research may also be done on your existing     tissue to identify new biomarkers.   "
85988|NCT02160496|"     The objective of the study is to assess the effect of diets with different protein     composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on     body weight and lipid profile in overweight and obese women. A dietary intervention is     carried out during 3 months in 90 women who are individually randomized to an hypocaloric     diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35%     carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat     and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or     shoulder of lamb) by providing up to 15 different recipes to participants to use them as part     of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention,     the following parameters are determined: anthropometric (weight, waist circumference, body     mass index and body composition), blood pressure, dietary (72-hours dietary registry) and     exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL     cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin,     ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants     will be advised to follow the prescribed diets during the next 3 months. Monitoring visits     with the nutritionist will not be performed. A follow-up visit will be done after 3-months of     end of intervention (at 6-months after beginning the study) to assess the long-time efficacy     on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist     circumference, body mass index and body composition) will be determined.   "
85989|NCT02160483|"     Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin     labelling, functional connectivity, diffusion tensor imaging and magnetic resonance     spectroscopy.   "
85990|NCT02160470|"     This study tests whether exposure therapy for fear of snakes or spiders is enhanced by the     addition of a brief fear retrieval trial prior to treatment, and the use of compound     extinction during treatment. The goal of the study is to determine whether these behavioral     techniques enhance the efficacy of exposure therapy, one of the most empirically supported     treatments for anxiety disorders.   "
85991|NCT02160457|"     The aim of this study is to test the hypothesis, that improvements in gait pattern following     individually tailored interventions guided by instrumented 3-dimensional gait analysis are     superior to those used in 'care as usual'.   "
86009|NCT02160223|"     Incomplete recovery of neuromuscular function after surgery can lead to respiratory     complications. Patients with obstructive sleep apnea (OSA) are prone to respiratory     complications after surgery. Neostigmin and sugammadex are used for neuromuscular reversal.      The aim of this study was to compare sugammadex and neostigmin regarding efficacy, incidence     of respiratory complications and cost in patients undergoing surgery for OSA   "
85992|NCT02160444|"     Investigation is designed to determine whether the gold standard for treating anxious youth     is enhanced by teaching parents to become their anxious child's CBT coach. Children (7-17     years old) with either Generalized Anxiety Disorder, Social Phobia, or Separation Anxiety     Disorder are treated with a combination of the Coping Cat Program and a parent-training     intervention that is designed to teach the child's parents the same cognitive and behavioral     skills that the child is learning and how to help their child to complete exposure     activities. The research methods are parallel to those used in the CAMS study so that this     data can be merged with that data set to evaluate the relative efficacy of the enhanced     intervention.   "
85993|NCT02160431|"     The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.   "
85994|NCT02160418|"     In this randomized controlled study, the investigators compare two classes of behavioral     approaches to change habits and health outcomes with an application to dental health:     cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid     to correctly answer health-related quizzes. Under behavioral incentives subjects earn money     for making healthy choices. The investigators apply these incentives to toothbrushing, a     daily health-related behavior critical to the prevention of dental caries and periodontal     disease, two high-burden conditions among US adults.   "
85995|NCT02160405|"     Nutritional deficiencies can lead to a number of health problems in children. In Latin     America and the Caribbean countries, are registered so much problems of insufficient     ingestion of food as of imbalances in the composition of the diet. These latter are expressed     in the absence of micronutrients (iron, iodine, zinc, vitamin A), becoming a major health     burden in developing countries. Being the globally's leading risk factor for disease and     death, with hundreds of millions of pregnant women and young children particularly affected.      Justification: In Nariño, Colombia higher levels of malnutrition are presented with respect     to country, just as micronutrient deficiency in children 1 to 4 years is higher than the     national average. Most of these households are poor families with restrictions on access to     food sources of these micronutrients, which is reported in a consumption of fruits,     vegetables, milk products and meat, less than the national average. In this place is     developing a project that aims to improve potato in higher yield, nutrition and resistance,     for contribute to increase food security of native communities.      Objective: Evaluate the effect on iron levels generated by the inclusion of native potato in     the diet of children aged 2-5 years in institutional beneficiaries modality ICBF, in the     municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto. Nariño. Colombia      Methods:      Design: A cluster randomized controlled trial. Open label Setting: 6 clusters, municipalities     of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto (two towns), which will be randomly     assigned to 2 groups: the treatment group that receives native potato, and the control group     that receives traditional potato, that will be include in the usual Institution meal     Participants: children from 2 to 5 years, beneficiaries of programs in institutional modality     of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto.      Main outcome measures: serum ferritin and transferrin levels      The study was conducted in the form of institutional programs ICBF, in the municipalities of     Carlosama, Guachucal, Túquerres, Cumbal and Pasto. Colombia. One hypothesis to a queue based     on the changes that occur over time after surgery in the mean values (μ) of serum ferritin in     the treatment group compared with the control group. A sample size of 212 children were     calculated. The study has been presented and approved by the Ethics Committee of the Faculty     of Medicine of the National University of Colombia and the Institutional Review Board of the     participating institution. All parents of participating children must sign a written form to     accept the voluntary participation of their child in the study.   "
85996|NCT02160392|"     The female upper genital tract is a unique compartment involved in HIV pathogenesis.   "
85997|NCT02160379|"     This is a cross-sectional study enrolling        -  11 weight-stable, formerly obese female patients 1-5 years after Roux-en-Y gastric          Bypass (RYGB)        -  11 age- and weight-matched female subjects        -  10 normal weight (Body Mass Index 19-25 kg/m2) subjects The following measurements will          be performed in each participants in basal conditions (after an overnight fast) and          after ingestion of a standard meal        -  electroencephalographic recordings of visually evoked potential after presentation of          food- or non-food pictures        -  plasma concentration of metabolites (glucose, fatty acids), glucoregulatory hormones          (insulin, glucagon), gastro-intestinal hormones (Gastric Inhibitory Polypeptide (GIP),          Glucagon-like Peptide-1 (GLP1), ghrelin,Cholecystokinin (CCK), and bile acids Aims of          this observational study are        -  to evaluate the effects of RYGB on brain perception of food related visual stimulation        -  to search for relationships between RYGB effects on brain responses and          gastro-intestinal hormone secretion   "
85999|NCT02160353|"     The role of this study is to focus on the potential role of abiraterone acetate in     treatment-naive patients newly diagnosed with high-risk localised prostate cancer requiring     combined hormonal therapy and radiotherapy.   "
86001|NCT02160327|"     The specific aims of the the investigators studies are as follows:        -  To collect the tear samples from patients with different ocular surface disorders,          including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS).        -  To evaluate the differential expression of tear cytokines and pH values between          different ocular surface disorders.        -  To collect the surgical conjunctival specimens from the patients with SLK and          conjunctivochalasis.        -  To evaluate the factors inducing mast cell migration and how mast cell is activated in          SLK via surgical specimens and cultivated fibroblast.   "
86002|NCT02160314|"     This study will evaluate the safety of the pessary device by objective evaluation of vaginal     wall integrity and subjective assessment of comfort during in-use conditions.   "
86003|NCT02160301|"     The study is a prospective, randomized, open-label comparison of a multimodal regimen and a     standard, narcotic-based regimen for postoperative pain control in patients undergoing     surgery for an operatively indicated, isolated extremity fracture. The investigators will be     measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse     events and fracture union. The investigators hypothesize that this multimodal regimen will     lead to improved pain, less narcotic use and improved satisfaction as compared to the     standard regimen.   "
86004|NCT02160288|"     The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve     symptoms of constipation in obstructed defecation syndrome (ODS).   "
86005|NCT02160275|"     In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This     system for automated control of blood glucose in patients with type 1 diabetes was tested in     the clinical research center as well as at the home of the patients. Glucose control with     automated closed loop control was comparable to patient-managed open loop control.      The closed loop system has been further developed and miniaturized (from backpack to     smartphone size) in order to interfere as little as possible with daily patient life. The aim     of this trial is to assess the efficacy of the new prototype at the home of the patient. It     is hypothesized that the closed loop system provides better glucose control than standard     open loop therapy.   "
86006|NCT02160262|"     To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with     Attention Deficit Hyperactivity Disorder (ADHD)   "
86011|NCT02160197|"     The purpose of this study is to examine the effect of variations in practice, ranging from     early functional rehabilitation to complete immobilsation in post operative patients with     ankle fixation following fractures. The primary goal of any post-operative regimen is to     attain full weight-bearing and as close to pre-injury levels of activity as soon as possible.      We seek to establish the effect on (1) functional outcome, (2) complication rates and (3)     time to return to work of three different approaches to rehabilitation after ankle fracture     fixation in order to produce a standardised, evidence-based guideline for our unit. We also     aim to perform a cost analysis for each approach.   "
86012|NCT02160184|"     The aim of the study is to assess the efficacy and safety of a closed-loop system consisting     of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control     System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and     post-breakfast periods. Intervention will be to apply the automated closed-loop system by     administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a     continuous glucose measurement (CGM) system.   "
86013|NCT02160171|"     A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure     Detection: ANSeR   "
86014|NCT02160158|"     The purpose of this study is to evaluate the relative bioavailability of 2 new     bead-in-capsule formulations compared to the commercial extended-release formulation (both     fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on     the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).   "
86015|NCT02160145|"     The purpose of the study is to determine whether tolvaptan is effective and safe for the     treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney     disease (ADPKD)   "
86016|NCT02160132|"     This prospective, randomized, controlled, multi-center clinical trial will evaluate the     effect and security of steroids therapy for patients of IgA nephropathy with active     pathological changes,including crescents,necrosis and microthrombus.   "
86017|NCT02160119|"     Several studies seem to indicate that emotional attention and change-related attention are     impaired in ASD. The goal of this study is to identify the relationships between those two     types of automatic attention in visual and auditory modalities in subjects with ASD compared     to healthy controls and also, over the course of development (children, adults). In order to     achieve this goal, the investigators will use complementary techniques (EEG and MRI-based     techniques (fMRI, DTI)).   "
86018|NCT02160106|"     The phase I dose escalation study will investigate the safety, tolerability, and     pharmacokinetics of the TGF-β pathway inhibitor TEW 7197 in subjects with advanced,     refractory solid tumors.   "
86056|NCT02159612|"     An investigation of disease progression in adult danish patients with facioscapulohumeral     muscular dystrophy. The disease progression is followed for a year with two test-days,     including functional muscle tests and a MRI scan of muscles in the back and legs.   "
86019|NCT02160093|"     Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric     outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and     Gerontology, National Taiwan University Hospital, this study will be conducted to examine the     impacts of the specific co-morbidities and ageing psychology on the outcomes of     frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be reviewed     after frailty being considered in the elderly with co-morbidity condition. In addition, the     conceptual framework and corresponding measuring instrument of mental frailty will be     expected developed.   "
86020|NCT02160080|"     End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for     liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver     transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani     et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver     transplantation.(Bzowej et al., 2011)      Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver disease     patients awaiting for liver transplantation annually. If the HCV viral load can be     significantly reduced or sustained virologic response (SVR) can be achieved by triple therapy     with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver     transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we can     reduce the risk of early fibrosis progression in the liver graft, and hopefully, improving     graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani et al,     2011).      We aim to conduct an prospective, open label, single arm study. This study design is single     arm to treat HCV patients with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC)     triple therapies before liver transplantation for patients with detectable HCV RNA. The total     number of patients would be around 20 cases included in the study and all of them will take     Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The     experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus Ribavirin.     Then after, triple therapy with Boceprevir + Peg-Interferon α-2b + Ribavirin will be used for     at least 16 weeks or maximal 44 weeks before transplantation. Normal practice based on the     treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver transplant center will     be done before enrollment. Patients will be monitored for all the efficacy and safety     endpoints during the treatment period. HCV RNA will be checked at time of transplant.     Finally, patients will received regular monitoring of HCV RNA 1, 3, 6, 9, 12 months after     liver transplantation.   "
86021|NCT02160067|"     The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and     relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation     BTDS patches.   "
86022|NCT02160054|"     To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation     when converted from cyclosporine   "
86023|NCT02160041|"     The purpose of this signal seeking study is to determine whether treatment with BGJ398     demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or     hematologic malignancies to warrant further study.   "
86024|NCT02160028|"     Information about the effectiveness of treatment has been found to reduce pain, termed     placebo analgesia. In this study it will be investigated whether this finding translates to     the dental clinic. It will be investigated whether information that suggested that minimal     pain will be experienced during filling therapy, can reduce the pain associated with that     procedure compared to a group that receives standard information. All patients will receive     the same amount of anesthesia and similar procedures during filling therapy. It is predicted     that extended information should reduce pain, and that the reduction in pain should be     associated with a reduction in stress.   "
86041|NCT02159807|"     The purpose of this study is to determine what dose of medication administered through a     combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of     side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor     floor (depending on the physician preference) but the idea is to quantify safety, efficacy     and side effects for each of these doses.   "
86025|NCT02160015|"     This phase I trial studies the side effects and best dose of lenalidomide when given together     with ibrutinib and rituximab in treating patients with chronic lymphocytic leukemia or small     lymphocytic lymphoma that has come back, has not responded well to prior treatments, has     spread to other parts of the body, or cannot be removed by surgery. Biological therapies,     such as lenalidomide, use substances made from living organisms that may stimulate or     suppress the immune system in different ways and stop cancer cells from growing. Ibrutinib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Giving     lenalidomide together with ibrutinib and rituximab may kill more cancer cells.   "
86026|NCT02160002|"     The objective of this proposal is to evaluate whether weaning from an incubator to a crib at     lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay     among moderately preterm infants.      The hypothesis of this study is that length of hospital stay (from birth to discharge) will     be decreased among moderate preterm infants weaned from an incubator to an open crib at a     lower versus higher weight, 1600g vs. 1800g.   "
86027|NCT02159989|"     This phase I trial studies the side effects and best dose of sapanisertib and ziv-aflibercept     in treating patients with solid tumors that have come back and have spread to another place     in the body or cannot be removed by surgery. Sapanisertib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Ziv-aflibercept may stop the growth     of solid tumors by blocking the growth of new blood vessels necessary for tumor growth.     Giving sapanisertib with ziv-aflibercept may kill more tumor cells.   "
86028|NCT02159976|"     1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and          to establish more effective first-line regimen for the eradication of Helicobacter          pylori in Korea.        2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of          functional dyspepsia   "
86029|NCT02159963|"     The investigators aim to investigate the effect of high-intensity training in patients with     facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise     without muscle damage.   "
86030|NCT02159950|"     This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod     works in treating patients with hormone-resistant prostate cancer that has spread to other     parts of the body. Vaccines made from a person's tumor cells and white blood cells may help     the body build an effective immune response to kill tumor cells. Tasquinimod may stop the     growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor     growth. It is not yet known whether sipuleucel-T is more effective with or without     tasquinimod in treating prostate cancer.   "
86031|NCT02159937|"     The purpose of this study is to evaluate in vitro the potential of peptides, to modify,     phenotypically and functionally, the monocyte-derived dendritic cells of patients with     metastatic cancer.   "
86032|NCT02159924|"     This study aims to investigate posture-mobility associations in the upper quadrant by means     of smartphone measurements   "
86033|NCT02159911|"     A randomized, double blind study to compare 200 and 400 mcg misoprostol for cervical     preparation before hysteroscopy.   "
86035|NCT02159885|"     Automatically titrating continuous positive airway pressure (APAP) and continuous positive     airway pressure (CPAP) are considered first-line treatments for obstructive sleep apnea.     There is a growing body of evidence that suggests that early patient education and     intervention may improve adherence with positive airway pressure. The investigators plan a     prospective, randomized trial to see if telemonitoring in the first several weeks of PAP     therapy improves adherence following 3 months of treatment.   "
86036|NCT02159872|"     The goal of this clinical research study is learn if omacetaxine can help to control MDS. The     safety of this drug will also be studied.   "
86037|NCT02159859|"     The purpose of this study is to determine the amount of ertapenem in the blood over time     between hemodialysis session.   "
86038|NCT02159846|"     The aim of this study was to evaluate the effects of mixed herbs as ad-on therapy on blood     sugar and lipid profile of patients with established T2DM. A total 20 patients were consented     and were equally divided into the Control and the Test groups and was fed with the Placebo or     mixed herbs 4 g daily for 30 days, respectively. Blood samples were collected before and at     the end of the feeding period and analyzed for the parameters namely Fasting Blood Sugar     (FBS), 2 hours post prandial (2HPP) Glycosylated Hb (HbA1c) and Lipid Profile. The collected     data was analyzed using SPSS Statistical Software version 12.   "
86039|NCT02159833|"     The investigators will conduct low-dose intranasal allergen challenges on     children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut.     The data will be used to determine the safety and potential utility of intranasal food     challenges in the diagnosis of food allergy.   "
86040|NCT02159820|"     Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer     death in women. Most patients are typically diagnosed with advanced-stage disease.     Platinum-paclitaxel regimen has been widely adopted as a standard first-line treatment for     advanced ovarian cancer. Multiple collaborative randomised phase III trials evaluating the     addition of a third chemotherapy agent, maintenance therapy or alternative taxanes failed to     demonstrate significant improvements over a standard carboplatin/taxane doublet.      Decitabine (DAC), one major DNA demethylating agent, has been approved for treatment of     preleukemic hematological disease myelodysplastic syndrome (MDS) by the Food and Drug     Administration. Past trials of these with high doses, i.e., the use of maximal tolerated     dose, for patients with solid tumors showed a low therapeutic index, due to extreme     toxicities that have probably confounded the ability to document the true clinical response.      Low dose DNA demethylation agent decitabine (DAC) can resensitize the therapeutic indexes of     resistent ovary cancer cells in vivo and in vitro.      The investigators hypothesized that DAC-triggered epigenetic reprogramming of tumor cells and     possible immune cells could induce pronounced long-dated clinical effect by     chemosensitization- and immunopotentiation-driven maximal eradicating roles on the     minimal/residual lesions in primary patients with poor prognosis.   "
86042|NCT02159794|"     The purpose of this study is to evaluate the safety and performance of the HLT System in     patients with severe aortic stenosis who present at High Risk for aortic valve replacement     surgery.   "
86043|NCT02159781|"     The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology,     diagnosed with generalized moderate - severe chronic periodontitis.      treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions     and motivation.      Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.      Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment     has an affect on saliva components.   "
86044|NCT02159768|"     The Airtraq is a battery powered single use optical laryngoscope with a channel to hold and     guide the tracheal tube into the trachea. It enables tracheal intubation in patients with     normal and difficult airways, by enabling laryngoscopy without neck movement. As a single use     device, it is cost effective to have these placed in emergency equipment kits, and for use by     emergency and military personnel.      However, it does have several limitations. The Airtraq requires the user to place his/her eye     to the eyepiece in order to see the advancement of the laryngoscope and the tracheal tube,     which may be difficult if the patient is on the ground or in emergency scenarios. Only the     user can see through the eyepiece and any assistants are unable to view the larynx, this     makes it difficult for assistants to help the operator.      Many handphones now incorporate high quality cameras. In this study, we will evaluate the     effectiveness of using the iPhone to aid laryngoscopy with the Airtraq optical laryngoscope     during laryngoscopy and intubation in 30 patients presenting for elective surgery under     general anaesthesia. We have manufactured an attachment that fits over the eyepiece of the     Airtraq, to hold an iPhone to the eyepiece. This will enable to operator and assistants to     simultaneously view the insertion of the Airtraq, view the larynx and view the passage of the     tracheal tube into the trachea.   "
86045|NCT02159755|"     This phase I trial studies the side effects and best dose of ibrutinib and palbociclib in     treating patients with previously treated mantle cell lymphoma. Ibrutinib and palbociclib may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Palbociclib may also help ibrutinib work better by making cancer cells more sensitive to the     drug.   "
86057|NCT02159599|"     This is an open label randomized clinial trial to evaluate the treatment with     darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with     darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or     abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.   "
86058|NCT02159586|"     The objective of this study is to determine if Gastric Electrical Stimulation may influence     vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.   "
87606|NCT02139358|"     The purpose of this study is to evaluate the safety and activity of gemcitabine plus     trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor     2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus     HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.   "
86046|NCT02159742|"     From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic     diseases both on prospective research protocols (for head and neck cancer, pleural     malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for     FDA approved and off label or compassionate exemption indications (neoplasms of the skin,     bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize     quality of life and organ function while minimizing the chance of tumor recurrence. As such,     we would like to retrospectively review the treatment parameters of all patients who     undergo/underwent PDT (including operative notes and photodynamic therapy records) and     treatment outcomes (including all organ functions, performance status, tumor recurrence,     laboratory values and any other data present in the routinely documented follow up visits).     For patients who have died or were lost to follow-up prior to initiation of this study, a     retrospective review of available data will be performed. For patients who are still being     actively followed after PDT or who receive PDT after the initiation of this study, informed     consent will be obtained for obtaining continued follow-up data prospectively and any     previous data will be collected retrospectively.. These subjects will continue to receive     care from their current physicians according to standard medical practice and no attempt will     be made to alter the types of follow-up, radiologic or other diagnostic studies or medical     treatment as a result of enrollment in this study. All data will be de-identified and added     to our already existing PDT treatment outcome databases for outcomes analysis, quality     improvement and reporting of results in abstract and manuscript forms.   "
86047|NCT02159729|"     Long-term follow-up study of subjects who completed Kythera-sponsored trials of ATX-101     (06-03, 07-07, 09-15)   "
86048|NCT02159716|"     Phase I study to establish safety and feasibility of intravenously administered lentiviral     transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose     escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian     cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3     and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will     dose deescalate by 10-fold.   "
86049|NCT02159703|"     To determine 2-year local (primary tumor site) control and toxicity rates in patients     receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely     resected, HPV-positive SCCA of the oropharynx.      To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS,     omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of     the oropharynx.   "
86050|NCT02159690|"     This study investigates the pathologic effects of the combination of enzalutamide,     abiraterone acetate, dutasteride, and degarelix when given for 12 weeks prior to     prostatectomy in men with localized prostate cancer.      Enzalutamide, an androgen receptor (AR) antagonist, blocks binding of testosterone to the AR     as well as preventing nuclear translocation of the AR and DNA binding. Abiraterone acetate     inhibits the CYP17 pathway, which is involved in the formation of androgens. Dutasteride is a     5-alpha-reductase inhibitor which blocks conversion of testosterone to dihydrotestosterone.     Degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, binds to GnRH receptors on the     pituitary gland thus suppressing testosterone release from the testes.      Therefore it is hypothesized that the combination of enzalutamide, abiraterone acetate,     dutasteride, and degarelix will result in near-complete AR inhibition and produce favorable     pathologic changes after 12 weeks of therapy.   "
86051|NCT02159677|"     The purpose of this study is to assess neck and low back pain using Electrical Impedance     Myography (EIM) in order to develop an algorithm to aid primary care providers (PCPs) in the     diagnosis of neck/back pain. Secondary goals include the refinement of EIM technology and     associated software of ease-of-use and interpretation by PCPs and staff.   "
86052|NCT02159664|"     Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess     the changes in upper airways obstruction levels before and after Didgeridoo practice in     moderate OSA patients.   "
86053|NCT02159651|"     This study is to evaluate the safety and the efficacy of Prograf in patients with     interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical     setting.   "
86054|NCT02159638|"     Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1     diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides     a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM measure the glucose level     by a sensor in subcutaneous tissue, there is uncertainty in the estimation of blood glucose     levels. The accuracy of a certain CGM system can be assessed by comparing the glucose levels     estimated by CGM with measured glucose levels in plasma. In the current study, we will     compare the accuracy of the 2 CGM systems available on the market for clinical use in     patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness,     safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic     patients.   "
86055|NCT02159625|"     Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of     cardiovascular (CV) morbidity and mortality than do the general population and many     populations with other chronic diseases. This exceptional risk is explained in part by known     risk factors, such as diabetes, hypertension, and other uremia-related factors, including     vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating     inflammatory mediators. Recent studies suggest that blood pressure variability, especially     intra-dialytic hypotension (IDH) is the most significant risk factor for these CV events.     Studies have also shown that the use of IAB is capable of improving cardiovascular function     for avoiding or minimizing the development of an orthostatic hypotensive episode (OHE) in     patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes patients and     children with orthostatic intolerance, and post-dialytic orthostatic hypotension (PDOH).      The investigators propose a study to examine the use of an abdominal compression elastic     support (ACES) to prevent the development of IDH in patients who are known to be prone to     these episodes. The ultimate goal is to facilitate more effective and safer dialysis therapy.     The ACES has a configuration that is similar to a back-support work belt or an inflatable     abdominal band (IAB). All of these devices are wrapped around to compress the abdomen at the     waist.   "
87607|NCT02139345|"     This is a prospective, randomized, multicenter clinical study to compare the safety and     efficacy of TC-A PS total knee system with TC-PLUS Solution PS total knee system in Chinese     subjects.   "
86059|NCT02159573|"     The primary objective of the study is to evaluate relapse activity, as measured by the     proportion of participants relapsed at 12 months, in participants with relapsing-remitting     multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the     real-world setting. The secondary objective is to further evaluate relapse activity, defined     as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during     the first year of Tecfidera treatment following transition from Tysabri treatment.   "
86060|NCT02159560|"     The investigators hypothesize that multi-port thoracic epidural catheters will provide     superior pain relief when compared to uniport catheters for post-surgical patients.   "
86061|NCT02159547|"     H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in     emergency department.      H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine     attack in emergency department.   "
86062|NCT02159534|"     Background : Brain vulnerability is particularly marked in preterm neonates and has long-term     consequences. Unlike lesions affecting other organs, those that affect the brain can     currently not 'be repaired' by producing new cells. However, exeprience-driven brain     plasticity allows the brain to reorganise its connections to compensate (at least partially)     the effects of an injury.      Purpose : To evaluate the influence of Primebrain stimulation programme administred by     parents until 6 months post-term on motor and neurophysiological development of infants born     <32 weeks' gestation or with birth weight <1500 g.   "
86063|NCT02159521|"     To evaluate the efficacy of ultrasound accelerated thrombolysis using the EkoSonic®     Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome     and chronic venous occlusion.   "
86064|NCT02159508|"     The purpose of this study is to assess the effect of a pre-planned patient-adjusted intensive     nutritional counselling given by a dietitian several times during (chemo)radiotherapy vs.     individualized nutritional counselling given by a dietitian once in the beginning of     (chemo)radiotherapy and thereafter on-demand in patients with head and neck squamous cell     cancer.   "
86065|NCT02159495|"     This phase I trial studies the side effects and the best dose of genetically modified T-cells     after lymphodepleting chemotherapy in treating patients with acute myeloid leukemia or     blastic plasmacytoid dendritic cell neoplasm that has returned after a period of improvement     or has not responded to previous treatment. An immune cell is a type of blood cell that can     recognize and kill abnormal cells in the body. The immune cell product will be made from     patient or patient's donor (related or unrelated) blood cells. The immune cells are changed     by inserting additional pieces of deoxyribonucleic acid (DNA) (genetic material) into the     cell to make it recognize and kill cancer cells. Placing a modified gene into white blood     cells may help the body build an immune response to kill cancer cells.   "
86084|NCT02159248|"     The purposes of this study are to:        -  Evaluate the safety and toxicity of tolfenamic acid when used with gemcitabine and          radiation therapy in patients with locally advanced or metastatic pancreatic cancer.        -  Determine the maximum-tolerated dose (MTD) of tolfenamic acid when used with gemcitabine          and radiation in pancreatic cancer.        -  Characterize the pharmacokinetic profile of tolfenamic acid when used with gemcitabine          and radiation.        -  Assess the anti-tumor response to tolfenamic acid when used with gemcitabine and          radiation in patients with advanced pancreatic malignancies.   "
86066|NCT02159482|"     This research study is for people who have previously received cancer vaccines. The     investigators are testing a form of therapy known as interferon alfa-2a, which is     commercially available as the drug Roferon®-A, to see if it can be used to help boost the     effects of the cancer vaccine and help the immune system attack the cancer.      It is believed that the body's immune system can attack tumor cells and kill them. This is     thought to be due to immune cells called T cells which can recognize special proteins on the     surface of tumors as a signal to fight the cancer. However, the vaccine may not work very     well if the protein signal is too weak for the T cells to find your tumors. The investigators     think that interferon alfa-2a can signal the cancer cells in the body to make more proteins     that may allow the T cells to recognize and kill the cancer cells better.   "
86067|NCT02159469|"     Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using     an auto-injector   "
86068|NCT02159456|"     1. Nutritional support during critical illness is important to improve the clinical outcome          of patients. Recently, the apply of early enteral nutrition is recommend in critically          ill patients on basis of data that enteral nutrition can be helpful to prevent the          hospital-acquired infections.             -  However, in critically ill patients, the smooth progress of nutritional support is               often hindered by gastrointestinal intolerance, underlying clinical condition, and               temporal necessity of procedure or operation.             -  Continuous feeding method, compared with intermittent feeding, is expected to               reduce the risk of gastrointestinal intolerance, and improve the nutritional               support, but this hypothesis is not supported by appropriate evidences.        2. We will elucidate to compare the efficacy and safety of the continuous feeding method in          critically ill patients, compared with the intermittent feeding method.             -  Prospective, randomized controlled study             -  Primary outcome: the achievement rate of target nutritional goal within 7 days               after the start of enteral nutrition             -  Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency               of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical               ventilation   "
86069|NCT02159443|"     Hu14.18K322A is a monoclonal antibody developed at St. Jude Children's Research Hospital     (SJCRH) that is made to bind to cancer cells that have a molecule called GD2 on their     surface. Sometimes the human body will make an antibody to the therapeutic antibody (like     hu14.18K322A) that is being given for treatment. These are called human anti-human antibodies     (HAHA). When testing for HAHA in a previous cohort of patients who received hu14.18K322A, it     was found that some patients tested positive for high levels of an antibody before receiving     hu14.18K322A or any other anti-GD2 antibody. In this study, investigators would like to know     more about the nature of this pretreatment antibody, how often is it present, and if in the     laboratory it increases the killing of tumor cells.      OBJECTIVES:        -  To determine whether pretreatment anti-therapeutic antibodies (PATA) represent          antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2          antibody hu14.18K322A        -  To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro   "
86100|NCT02159040|"     The primary objective of the study is to compare the overall response rate (inclusive of     complete response, partial response and hematologic improvement) per IWG 2006 criteria in     patients with higher risk MDS treated with azacitidine with or without deferasirox achieved     over the course of one year. Hematologic improvement must be maintained for at least 8 weeks.   "
86070|NCT02159430|"     Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder     (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1     esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general     population. From this period the link between HAE and psychiatry was interrupted, however     genetic issues could not comprehensively explain the clinical evolution of the disease.     Clinical studies show an evident gap between genotype and phenotype of HAE. For this still     controversial question, we have designed this cross-sectional study in order to establish the     relationship between HAE clinical manifestations and neurobiological/psychopatological     parameters.   "
86071|NCT02159417|"     A lot of data show that therapeutic education is beneficial for diabetic patients. In the     French jails, there are very few programs of therapeutic education while this population is     usually precarious with no access at care sector before the jail.      The purpose of this study is to determinate if the therapeutic education of the diabetic     patients is possible in the Paris jail La Santé.   "
86072|NCT02159404|"     Nasal mucus as first line defense barrier of the nasal mucosa contains a variety of proteins     that act as functional units. We recently showed that the nasal mucus proteome between     allergic rhinitis patients and healthy controls is significantly altered. On protein level,     immune response in allergic rhinitis is enhanced and barrier function is reduced as reflected     by increased epithelial permeability. Moreover, there is an unfavorable imbalance in innate     anti-proteases. Proteases in pollen grain could therefore not be adequately deactivated in     the mucus further damaging the epithelium which leads to submucosal penetration of allergens     and facilitated presentation to antigen presenting cells.      The aim of the present project is to show changes in nasal mucus proteome between allergic     rhinitis patients and healthy controls over the pollen and non pollen season and to further     determine whether and if so how the proteome changes under immunotherapy. For the first aim     patients and healthy controls will be enrolled at two time points namely during the pollen     season and out of the pollen season. Statistical differences will be determined within the     groups and between the groups. The protein changes over the time course reflect how allergics     but also healthy controls react to allergen challenge. The results should give insight on     possible biomarkers that could be used for diagnostics and therapy. Protein substitution or     inhibition may be a future therapy to reinforce the barrier function of nasal mucus and treat     allergic rhinitis symptoms. The effect of immunotherapy as sole causal therapy will be     determined and therapy responders will be compared to non-responders. We hypothesize that     responders will show proteome changes similar to healthy conditions. This further concretizes     distinct proteins as biomarkers that could be used as therapeutic agents. Moreover proteome     changes could be used to predict and monitor therapeutic success or failure and patients may     be stratified to be subjected to other therapeutic strategies than immunotherapy saving time     and money.      Mucus will be collected with a special suction device equipped with a mucus trap. Then,     proteomic analysis will be performed by LC MS/MS mass spectrometry. Database search will     identify distinct proteins and their function, origin etc. will be annotated. Protein groups     will be analyzed through pathway enrichment and cluster analysis. By this means complex     proteomic data can be visualized for a better understanding of global changes in protein     networks and functions.      Investigating the nasal mucus proteome in diseased and healthy state leads to a better     understanding of its barrier function and reaction to allergens. Distinct proteins and/or     proteins groups could be used as biomarkers for novel diagnostic and therapeutic approaches.     Furthermore, mechanisms of immunotherapy in responders and success or failure of therapy     could be determined.   "
86073|NCT02159391|"     The purpose of this study is to determine whether the Brief Motivational Interview will     produce a significantly reduction in risk behavior than usual treatment 3 months after     discharge from hospital in people who have survived a traumatism.   "
86095|NCT02159105|"     This study is designed to see if abdominal ultrasound after planned cesarean delivery can     identify women with ongoing intra-abdominal bleeding.   "
86074|NCT02159378|"     The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much     higher in specific populations.      The specific treatment of gestational diabetes (diet, control weight gain, self monitoring     glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and     preeclampsia compared with abstention therapy, without additional risk of caesarean section.      Several early studies have shown that the determination of fructosamine is a very bad way of     diagnosis for Gestational Diabetes. However, few studies have investigated the relationship     between the determination of serum fructosamine and put under insulin in case of Gestational     Diabetes.      The purpose of this study is to determine if serum fructosamines rate can be a predictive     marker of the starting insulin at the patients suffering from Gestational Diabetes   "
86075|NCT02159365|"     To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible     and safe.   "
86076|NCT02159352|"     The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or     lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.   "
86077|NCT02159339|"     Gastric carcinoma (GC) is the second leading cause of cancer death throughout the world. In     previous multi-center study, we have found that the prevalence of GDNF family receptor alpha     1(GFRA1), serum response factor (SRF), and ZNF382 methylation alterations were inversely and     coordinately associated with GC metastasis and the patients' overall survival throughout     discovery and testing cohorts in China, Japan and Korea. The present cohort study is to     investigate whether methylation of those genes can predict the metastasis and prognosis of     GC.   "
86078|NCT02159326|"     Physicians might be concerned that Adempas may have a metabolic interaction with oral     contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information     regarding lack of potential pharmacokinetic interaction has been communicated; there is a     need for more re-assurance and further data that there is no interaction between Adempas and     OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least     vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered     adequate to inform about safe use of Adempas with OCs.   "
86079|NCT02159313|"     To investigate relative bioavailability of crushed tablets suspended in apple sauce or water   "
86080|NCT02159300|"     The long-term purpose of the investigator's research is to understand the pathophysiological     basis of chronic pain. This will help provide a framework for the development of effective     treatments. The purpose of this specific study is to find if there are abnormal brain rhythms     in patients with fibromyalgia syndrome (FM) who are in pain since this will indicate     particular types of treatments.      FM is a disorder of the muscles and/or joints, and patients experience sever fatigue. FM     occurs more often in women than in men (3.4% of women, 0.5% of men). The diseases can appear     at any age, but in most of the cases it occurs in women of childbearing age. FM is considered     a chronic pain condition since the pain is persistent. Pain and tenderness can be widespread     throughout the body. FM patients are more sensitive to sound and pressure stimulation than     healthy controls, indicating that there may be changes in the brain. Also, pain is made worse     under conditions of stress.      Treatments for FM pain include life style changes such as exercise, dietary changes,     cognitive-behavioral therapy, medications and even surgery, but there is no accepted best     treatment. This is partly because the underlying cause of the pain is not well understood.     The design of this study is to record brain activity to find if there are abnormal brain     rhythms in people with FM that are not present in healthy adults of the same age.      Specifically, the investigators will test the hypothesis that constant low frequency     oscillations will be present in patients with chronic pain due to FM. This has been found in     people with other types of pain and is called Thalamocortical Dysrhythmia (TCD). The study     has two parts. In the first part, a complete medical history will be obtained, including a     description of the person's pain. In the second part the investigators will use     magnetoencephalography (MEG) to non-invasively record brain activity. The MEG data will be     analyzed in terms the presence of normal alpha rhythm and abnormal low and high frequency     oscillations. Each person will have an MRI so the investigators can localize the rhythms     recorded by the MEG in the person's brain using their MRI. The people who record and analyze     the MEG recordings will not know if the person is a healthy control or a FM patient. The two     parts will be joined to test the hypothesis and find if there is a correlation between the     people with abnormal low frequency brain rhythms and the presence or degree of pain.   "
86081|NCT02159287|"     Patients with Atrial fibrillation (AF) make a unique group of ischemic stroke, mostly caused     by emboli from the left atrial appendage. Oral anticoagulation (Warfarin) is recommended for     prevention of recurrent embolic stroke but it takes several days to reach a therapeutic     international normalized ratio (INR : 2.5) so bridging therapy with a short acting     intravenous anticoagulant is recommended until therapeutic INR level is reached. A common     strategy is to use intravenous unfractionated heparin (UFH) until a standard activated     partial thromboplastin time (aPTT) is reached and then initiating warfarin. Another strategy     is to use subcutaneous (SQ) injection of a low-molecular-weight heparin (LMWH) eg.     Enoxaparin.      The investigators will compare LMWH and UFH, focusing on risk of new stroke and mortality     rate.      METHOD: This study is randomized controlled trial that will be performed in 80 patients ages     between 18 and 75 with confirmed acute ischemic stroke purely due to AF who will be     hospitalized in Shiraz Medical University affiliated teaching hospitals. Patients will be     randomly assigned in two groups. A brain CT will be done to confirm the absence of     intracranial hemorrhage and to assess the size of cerebral ischemia.      First group will receive 1 mg of enoxaparin (Clexane, Sanofi, Paris) per kilogram of body     weight SQ every 12 hour with warfarin 5mg orally everyday and both drugs will be continued     until the target INR level (2.5) is reached then clexane will be discontinued.      The second group will receive continuous UFH infusion 1000 unit per hour and then the dose     will be adjusted to maintain a therapeutic aPTT (two times to baseline) level then warfarin     will be started (5 mg everyday).      The investigators will follow patients in both groups until target INR will be achieved (2.5)     and after that clexane and UFH will be discontinued. Adverse events will be assessed in both     groups for three months.      Data will be analyzed with Statistical Package for the Social Sciences (SPSS) version 15 and     Chi-square statistics.      Main outcome of our study will be evaluation of new stroke, mortality, central nervous system     (CNS) hemorrhage, major bleeding, drop out and other unwanted side effects in first week and     three months after stroke.   "
86082|NCT02159274|"     Breast cancer affects a large proportion of Danish women and late morbidity following breast     cancer treatment including pain, reduced motility and force of the arm and shoulder,     disturbed sensitivity, and lymph edema affects many patients. The risk for such late     complications have previously been carefully described by us and others in patients operated     by traditional methods, but the follow-up in most of these studies have been rather short ,     and long time follow-up results are not available. The impact of the new oncoplastic     techniques that allows more women to have breast conserving surgery is not known yet. These     operations are more extensive and therefore might be accompanied by more complications. The     purpose of this study is to give answer to that question.The study includes three parts.     First a questionnaire to patients who have breast conserving surgery performed in one of the     three breast units in Central Region Denmark. It contains questions regarding arm morbidity,     quality of life, comorbidity, and body image. The questionnaire should be filled in     preoperatively and 18 months after surgery. The second part consists of an objective     evaluation of shoulder and arm function and cosmesis before and after breast conserving     surgery with and without oncoplastic techniques. This should be performed at baseline before     surgery and 18 months later. The third part is a long time follow-up of patients after breast     conserving surgery without oncoplastic techniques. This group of patients is recruited from     three breast units in Central Region Denmark. It contains questions regarding arm morbidity,     quality of life, comorbidity, and body image. The questionnaire should be filled in     preoperatively and 18 months after surgery. The second part consists of an objective     evaluation of shoulder and arm function and cosmesis before and after breast conserving     surgery with and without oncoplastic techniques. This should be performed at baseline before     surgery and 18 months later. The third part is a long time follow-up of patients after breast     conserving surgery without oncoplastic techniques. This group of patients is recruited from     the cohort in a previous study with 18 months follow-up following breast conserving surgery     without oncoplastic technique.   "
86083|NCT02159261|"     Local prospective multicenter non-comparative non-interventional observational study. It's     planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment     for 13 cycles in real practice.   "
86126|NCT02158702|"     Asian patients with relapsed myeloma after prior treatment with bortezomib and lenalidomide     will treatment on pomalidomde and dexamethasone.      Baseline, follow-up, survival and toxicity information will be collected.   "
86085|NCT02159235|"     The present study aims is to investigate:        1. whether patients suffering from acute resp. chronic ischemic heart disease show higher          levels for cadmium (Cd), lead (Pb) and mercury (Hg) than local and international          reference levels suggest;        2. the correlation between severity of coronary artery disease and angiogenic and          angiostatic factors (endostatin-ES, angiostatin-AS, VEGF-vascular endothelial growth          factor, osteopontin-OPN) The patient population consists of about 270 female and male          patients suffering either acute or chronic ischemic heart disease (AIHD:ICD-10 I21;          CIHD: ICD-10 I25).        3. whether patients suffering CAD and valve calcification (mitral annulus, aortic valve)          show higher levels of endostatin, angiostatin, osteopontin and VEGF compared to patients          with CAD but without valve (annulus) calcification The measurement of cadmium (urine),          lead, mercury, zinc, endostatin, angiostatin, VEGF (serum) and osteopontin (plasma) in          patients with angiographically verified coronary artery disease are in the fore.          Furthermore, basic laboratory diagnostics as well as data from coronary angiography and          echocardiography will be collected. Additionally, the investigators will inquire heavy          metal exposition during life by an interview.      Recruitment will be done during the in-patient stay at the General Hospital of Vienna,     Medical University of Vienna.   "
86086|NCT02159222|"     The purpose of this study is to determine whether an additional physical therapy program can     improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an     illness in which the body has a severe response to bacteria or other germs and develops     worsened function of a major organ such as the kidneys, heart, or lungs).   "
86087|NCT02159209|"     Some medications are known to cause kidney damage because the person is allergic to the     medication while others cause direct damage to the kidney because they are toxic at certain     concentrations. Risk factors for developing kidney damage have been identified for some     medications but not for all. Patients who are exposed to these important medications and     develop problems with their kidneys may have some genetic risk. The purpose of this study is     to determine the genetic risk factors for drug induced kidney injury. A better understanding     of the role of genetics for the development of kidney injury from medications will allow us     to better select medications, improve effectiveness of treatment and minimize harm.   "
86088|NCT02159196|"     The purpose of this multi-center randomized controlled non-inferiority trial is to determine     the effect of a strategy using routine nebulisation of mucolytics and bronchodilators (four     times daily) as compared to a strategy using nebulisation of mucolytics or bronchodilators     only on clinical indication (i.e. occurrence of persistent thick and tenacious sputum or     bronchospasm) in mechanically ventilated intensive care patients. The investigators will     examine the effects in terms of ventilator-free days, defined as the number of days alive and     free of ventilation at day 28 after start of ventilation.      We hypothesize that a strategy that uses nebulisation of mucolytics or bronchodilators only     on clinical indication not to be inferior to a strategy using preventive nebulisation of     mucolytics or bronchodilators with regard to the number of ventilator free days in ICU     patients at day 28.   "
86089|NCT02159183|"     This study will investigate the effect on the soft tissue that is in contact with a dental     implant with a modified surface of the neck (the part of the implant that is above the bone     and in contact with the soft gum tissue).   "
86090|NCT02159170|"     Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia     for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments     of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and     hyperalgesia are not yet understood in this group of patients. The investigators plan to use     NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to     investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic     resonance imaging and resting state network analysis.   "
86091|NCT02159157|"     This study is designed to randomly assign breast cancer patients requiring and agreeing to     chemotherapy into two groups. One group will be receive an exercise prescription aimed at     increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per     week. The other group will not receive a exercise prescription but their activity will be     recorded. The hypothesis is that participants that are most active will exhibit improved     chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for     inflammation in their blood.   "
86092|NCT02159144|"     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),     play an essential role in regulating whole-body energy homeostasis. Recent studies also     reveal the presence of a subset of cells in WAT that could be induced by environmental or     hormonal factors to become ''brown-like'' cells, and this ''beigeing'' process has been     suggested to have strong antiobesity and antidiabetic benefits. More recently, same studies     showed that cold stress stimulate the browning of subcutaneous white adipose. However, to the     investigators knowledge, there are no direct data that clearly show that cold stress can     promote the browning of subcutaneous white adipose.   "
86093|NCT02159131|"     This open-label, fixed-sequence crossover study aims to evaluate the effect of GSK1265744     (744) oral administration on the pharmacokinetics (PK) and pharmacodynamics (PD) of a     commonly used oral contraceptive (OC) product (combination of ethinyl estradiol and     levonorgestrel), in 20 healthy female subjects. Each subject will participate in a Run-in     Period (if needed), followed by a single-sequence Treatment Period. Subjects will receive     oral contraceptive containing Levonorgestrel and Ethinyl Estradiol on Days 1 to 21 and be OC     free on Days 22 to 28, during which withdrawal menses should occur. Subjects will receive OC     alone on Days 1 to 10. Levonorgestrel (LNG) and ethinyl estradiol (EE) PK will be determined     on Day 10. Subjects will then co-administer 744 and OC on Days 11 to 21. Levonorgestrel and     ethinyl estradiol PK will be determined again on Day 21 to assess if co-administration with     744 results in a significant change in OC exposure compared to OC alone. Subjects will return     to the study center for final follow-up evaluations 7 to 14 days after the last dose of study     medication (Days 28 to 35).   "
86094|NCT02159118|"     The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy     device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to     obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered     device will improve the quantity and quality of bone marrow biopsy specimens when compared to     the manual device.   "
86096|NCT02159092|"     Tobacco use kills more than 500,000 people in the United States each year. Although the use     of cigarettes has declined, the use of other tobacco products has remained steady. Waterpipe     smoking is a common form of tobacco smoking after cigarettes in the U.S. In fact, in 2007 the     American Lung Association issued a policy alert to warn consumers about this first new     tobacco trend of the 21st century (American Lung Association, 2007). Few studies have been     conducted on waterpipe smoking to investigate its harmful effects. Furthermore, no known     studies have evaluated treatments for smoking cessation in waterpipe smokers. This study aims     to test the role of contingency management (CM) in promoting abstinence from waterpipe     smoking for 5 weeks verified by salivary cotinine and to characterize self-reported nicotine     withdrawal symptoms. Based on the alarming growth rate over a short period of time in     waterpipe tobacco smoking, there is a critical need for clinical research to investigate     treatment modalities targeting smoking cessation for waterpipe smokers. Given the evidence     for the role of CM in promoting abstinence from many types of drug use, investigation of the     utility of CM for waterpipe smoking cessation is important and timely. Although Nicotine     Replacement Therapy is the mainstay treatment for treating nicotine dependence delivered     through cigarettes, the intermittent use patterns that characterize waterpipe smoking suggest     that CM may be more effective in promoting waterpipe smoking cessation. The evidence based     knowledge generated in this study may assist in the translation of the treatment program into     public health practice.   "
86097|NCT02159079|"     Sepsis is a common inflammatory response to infection characterized by hypovolemia and     vasodilation for which early administration of intravenous fluids has been suggested to     improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic     patients treated in the intensive care unit commonly receive significant volumes of     intravenous fluids with resultant positive fluid balance for up to a week after their initial     resuscitation. Observational studies have associated fluid receipt and positive fluid balance     in patients with severe sepsis and septic shock with increased mortality but are inherently     limited by indication bias. In order to determine the optimal approach to fluid management     following resuscitation in patients with severe sepsis and septic shock, a randomized     controlled trial is needed. The primary hypothesis of this study is that, compared to usual     care, a conservative approach to fluid management after resuscitation in patients with sepsis     and cardiopulmonary dysfunction will increase intensive care unit free days.   "
86098|NCT02159066|"     The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in     combination with targeted agents after progression on LGX818/MEK162 combination therapy, as     well as the safety and tolerability of the novel triple combinations.   "
86099|NCT02159053|"     The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus     placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration     with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and     to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite     current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.   "
86101|NCT02159027|"     Maraviroc is an antiretroviral medication that may help in improving mental function in HIV     infected patients with mental problems by decreasing inflammatory tendencies. We will test     this in a clinical trial of 42 HIV infected individuals with some mild to moderate mental     problems who are already on HIV medications and doing well. We will add Maraviroc or a sugar     pill to their HIV medications and see if mental function improves over 48 weeks. This study     will be conducted at 2 sites in Hawaii and Puerto Rico.   "
86102|NCT02159014|"     Regular physical activity improves physical and mental health and reduces the risk of heart     disease, stroke, cancer, diabetes, obesity and premature death from any cause. Unfortunately     the majority of adults are not active enough to reap these benefits. People who are inactive     and at high risk of stroke, heart disease, diabetes and dementia, and who may benefit from     increased activity can be identified in primary care by combining standard risk tools. These     high risk patients can be offered physical activity programmes that are designed to increase     longterm adherence. Aerobic dance is an activity that combines physical, social and cognitive     stimulation and allows easily adjusted intensity levels to meet individual needs. Engagement     in an activity program also provides opportunities to offer advice on healthy nutrition and     associated meal preparation skills. Information technology can be used to increase activity     participation. Video materials can be produced to guide activity participation at home,     thereby increasing overall activity participation. The investigators propose a feasibility     study of a multimodal dance-based physical activity and nutrition intervention aimed at     patients at high risk of stroke, heart disease, diabetes and dementia, in primary care     settings.   "
86103|NCT02159001|"     Electroconvulsive therapy (ECT) is one of the oldest neuromodulation treatments still used in     psychiatry. Only case reports and open label non-randomized studies have been published of     ECT in clozapine-resistant schizophrenia patients. The purpose of this trial is to study the     efficacy and cognitive effects of add-on ECT treatment (10-course) in schizophrenia patients     taking clozapine.   "
86104|NCT02158988|"     Patients with histological proven gastric cancer (including cancer of the esophagogastric     junction (AEG)) and synchronous peritoneal carcinomatosis, who fulfill the inclusion and     exclusion criteria, can be recruited in this study. There are two treatment groups (A and B).     The chemotherapy applied intravenously is the same in both groups and is approved for the     treatment of gastric cancer. Patients with negative or unknown HER-2 status will be     administered Epirubicin, Oxaliplatin and Capecitabine (EOX). Patients with positive HER-2     status will be treated with Cisplatin, Capecitabine and Trastuzumab (CCT).      The chemotherapy is followed by surgical cytoreduction in both groups. Patients randomized     into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion     with Mitomycin C and Cisplatin .      Patients in both groups receive 3 cycles of postoperative chemotherapy within 4-12 weeks     after the surgical procedure and are followed up for 30 months.      If progress of the tumor is detected the patient will no longer be treated according to the     study therapy. Patients of group B may get a HIPEC intervention without surgical     cytoreduction if contraindication to the drugs applied can be excluded.   "
86160|NCT02158260|"     It is a single center, prospective and self-controlled trial. We'd like to explore a new     method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)   "
86105|NCT02158975|"     Historically cutaneous and peripheral T-cell lymphomas have response rates of approximately     30% to standard chemotherapy regimens. We alternatively hypothesize that MLN9708 will be     active in this disease and will improve best objective response.      We will also determine the extent to which MLN9708 inhibits GATA-3 (Trans-acting     T-cell-specific transcription factor) expression, which is associated with poor prognosis,     and whether GATA-3 expression represents a novel predictive biomarker for MLN9708     sensitivity.   "
86106|NCT02158962|"     The purpose of this study is to combine a culturally tailored and integrated Risk Reduction     Intervention in the US Virgin Islands (USVI) in a clinical trial randomly assigning abused     women to a 1) Healthy Relationships experimental group of three sessions of risk reduction     interventions or 2) a Healthy Living comparison control group of three session of health     promotion activities to determine if the combined, intervention is safe and effective in a     test the following hypotheses:        1. Women in the integrated risk reduction intervention will score significantly lower on          outcome measures of intimate partner abuse (IPA) and STD/HIV risk behaviors end of          Session III and at 3 and 6 months than women in the control group        2. Women in the integrated risk reduction Intervention will score significantly higher on          IPA safety behaviors and STI/HIV prevention behaviors at end of Session III and at 3 and          6 months than women in the control group.      Several exploratory and major controlled studies on the mainland US have shown intimate     partner violence (IPV) and intimate partner abuse (IPA) to be risk factors for a variety of     physical, reproductive and mental health problems, including sexually transmitted infections     and HIV/AIDS, many of which are areas of known health disparity for African American and     Latina women. A recently completed study of African Caribbean and African American women in     the US Virgin Islands revealed that nearly one third of women reported lifetime partner abuse     and increased risk for sexually transmitted infections including HIV/AIDS. Abused women in     the USVI had significantly more risk factors for HIV/AIDS than did women who were not abused.      The proposed intervention combines an empowerment model designed to help abused women make     choices that protect the physical and emotional health of the woman and her family with a     sexual safety model designed to help her make choices to reduce her risk of acquiring an STI     or contracting HIV/AIDS. The integrated model adapts two interventions that have been tested     with African American women on the US mainland and found to be effective as separate     interventions for IPV and IPA and reducing the risk of STI/HIV. The adapted interventions     will be used with abused African Caribbean women based on an a priori assessment of the     cultural attitudes, beliefs and resources available to women living in an island environment     with limited resources.   "
86107|NCT02158949|"     In this study, the investigators will be developing and testing a mobile phone text message     intervention to reduce alcohol use for people at risk of alcohol dependence. The     investigators hypothesize that this intervention will be acceptable to participants, and that     they will stay in the intervention until it's one week completion.   "
86108|NCT02158936|"     Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin     receptor agonist that may be beneficial in medical disorders associated with     thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with     thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver     disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350     subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the     placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with     intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75     Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind,     parallel group, placebo-controlled study designed to explore the platelet supportive care     effects of eltrombopag versus placebo in combination with the standard of care     hypomethylating agent, azacitidine. The primary objective of this study is to determine the     effect of eltrombopag versus placebo on the proportion of subjects who are platelet     transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints     include overall survival, disease response, and disease progression.   "
86109|NCT02158923|"     The purpose of this study is to determine whether individualized ventilatory management     combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated     positive end-expiratory pressure and postoperative individualized ventilatory support will     decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of     stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all     patients at risk.   "
86110|NCT02158910|"     The purpose of the study is for investigation and collection of Aricept safety information     with a dose increase on Alzheimer's disease patients.   "
86111|NCT02158897|"     Evidence from bio-gerontology research from our laboratory and others have showed that     short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting     normal cells and tissues and potentially sensitizing malignant cells to chemo drugs.     Furthermore, STS improves risk factors associated with aging and age-related disease in     rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible     or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in     a pilot human trial. The objective of the study is to ascertain the impact of the     fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months.     The investigators hypothesize that the specially designed dietary regimen can reduce the risk     factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.   "
86112|NCT02158884|"     The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed     brace, called the IDEO ™ along with a physical therapy program, called Return to Run,     improves physical function. This brace was developed for wounded warriors who wanted to     return to an active lifestyle.      The primary objective of this study is to examine the benefits (and cost-benefits) of an     integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic     Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but     designed for scalability in the broader military environment (i.e. beyond San Antonio     Military Medical Center where the program was developed)   "
86113|NCT02158871|"     The purpose of this study is to compare the impact of a new workplace-based mental health     peer education program with standardized mental health literacy training on early     intervention and support for healthcare employees with mental health issues. Participants are     healthcare workers who volunteer to participate in one of the two twelve-hour group education     programs. It is hypothesized that the customized Beyond Silence peer education program led     by trained staff members with personal experience of mental ill-health will be more effective     in reducing the stigma associated with help-seeking and help-outreach regarding mental     ill-health in the workplace. The comparison group is a standardized mental health literacy     training program that has been widely implemented in both Canada and around the world. Change     in help-seeking/help-outreach behavior, mental health knowledge and beliefs of participants     will be assessed at three-month intervals; before, after and three months following the     educational intervention.   "
86114|NCT02158858|"     Open-label, sequential dose escalation and expansion study of CPI-0610 in patients with     previously treated Acute Leukemia, Myelodysplastic Syndrome,     Myelodysplastic/Myeloproliferative Neoplasms, and Myelofribrosis. CPI-0610 is a small     molecule inhibitor of bromodomain and extra-terminal (BET) proteins.   "
86115|NCT02158845|"     The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic     inflammatory disease affecting 10% of women. The objective of this study is to compare the     hemostatic effects of two treatments widely prescribed to women with endometriosis: the     levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog     (GnRHa) leuprolide acetate.      Hypothesis:      H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There is     alteration in hemostatic system with the use of GnRHa or LNG-IUS   "
86116|NCT02158832|"     This study is being conducted to determine if electro-acupuncture can reduce swelling of the     arm due to breast cancer treatment (commonly referred to as 'lymphedema'). Research conducted     on animals suggests that such treatment might be used to improve circulation leading to     reductions in swelling. Previous research in humans with lymphedema suggests that treatment     may be safe to use, although results regarding its efficacy in the reduction of swelling have     not yet been established.      This research will use sophisticated, non-invasive assessment methods to determine if a     single session of electro-acupuncture treatment can be effective for reducing lymphedema.     Results may be used to further develop our understanding of how electro-acupuncture can be     used in the management of this condition. Electro-acupuncture may provide a promising     complement or alternative to conventional lymphedema treatments such as compression     bandaging, massage therapy or surgery.   "
86117|NCT02158819|"     The purpose and primary objective of this study is to compare health economic outcomes     between the use of a patient-matched cutting guide (Visionaire) versus the use of standard     instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively,     intra-operatively and post operatively up until and including the six week post-operative     assessment. The secondary objectives of the study are to compare safety and early readmission     rates between the two techniques. The study hypothesis is that there is no difference in the     cost of the episode of care from hospital admission to discharge, including pre-operative     radiology costs and cost of resources, with the Visonaire patient-matched cutting guide     compared to standard instrumentation.   "
86118|NCT02158806|"     Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,     lifestyles and activity, especially in older patients. There are few effective treatments -     compression therapy (tight bandaging or stockings) helps healing, but about half the people     with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin     as well as using compression may speed up healing for VLU, but the current evidence is not     enough to change clinical practice. We will conduct a randomised controlled trial to test     whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.   "
86119|NCT02158793|"     The purpose of this study is to perform face transplants on people who have suffered severe     facial trauma with tissue and functional loss; and evaluate the acceptance and function of     the transplanted tissue. The aim of the transplant is to provide patient a more normal     appearance . Additionally we aim to restore functioning, movement, and sensation of their     face including that of the lips, mouth, and eyes.   "
86120|NCT02158780|"     Undescended Testis is the most common congenital abnormality of the genitalia in boys and it     is commonly managed by surgical intervention. Evidence in the medical literature to support     the superiority of either scrotal or inguinal (standard) orchidopexy is lacking. To determine     which technique is superior, this study focuses on the degree of post-operative pain after     surgery. Therefore, the objective of this randomized control trial is to determine if scrotal     orchidopexy reduces postoperative pain in children diagnosed with undescended testis when     compared to standard inguinal orchidopexy.   "
86121|NCT02158767|"     This clinical trial studies the use of a second infusion of donor hematopoietic cells that     have had removal of T cells for the treatment of engraftment failure after a first     hematopoietic stem cell transplant.      Hematopoietic cell transplants from donors can be complicated by complete or incomplete     failure of recovery of blood counts. This results in frequent needs for transfusions and     other methods to maintain blood counts at acceptable levels. One way of improving the blood     counts in the recipient is to give a booster dose of cells from the donor, but this is     associated with increased risk of an immune reaction from the donor cells against the     recipient cells. To decrease this risk, it is possible to decrease the amount of T cells,     responsible for this type of immune reaction. These cells are removed by a special handling     of the graft, which allows to remove the cells directly or indirectly (by selecting other     cells to stay in the graft).   "
86122|NCT02158754|"     This retrospective study will investigate clinician behavior in diagnosing patients with     possible obstructive coronary artery disease who received a CORUS® CAD result compared to     patients who did not have the test performed (matched control patients). The data collected     will be from primary care practices and will also assess one to two year health outcomes     (MACE, procedure complications). Furthermore, in these real world practice settings, the     study will investigate the economic impact of CORUS® CAD usage at each practice using     practice specific data, when available.   "
86123|NCT02158741|"     The overall purpose of this research is to examine and compare the effectiveness and costs of     a community-based intervention to support self-management with usual primary care for older     adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family     caregivers. Once the study is complete, the investigators will be able to determine if there     is any measurable difference in self-care management between usual care plus the intervention     versus usual care alone.   "
86124|NCT02158728|"     To collect supraventricular tachycardia (SVT) data for developing and testing sensing and     detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).   "
86125|NCT02158715|"     For Cardiopulmonary Resuscitation(CPR) education, depth of chest compression is most     important teaching point. However, the tool to feedback depth of chest compression like     Resusci Annie Skill Reporter(Laedal Medical AS, Norway) is very helpful but too expensive to     be used widely. In these days, smartphone free application can measure depth of chest     compression in real-time. This study assess the validity of depth of chest compression by     smartphone application, PocketCPR, as three sites of smartphone on arm or hand.      1. grap it in hand, 2. fix it on upper arm with arm band, 3. grap it in hand with arm band      To analyze the difference between Skill Reporter manikin and PocketCPR application, the     investigators will use Intraclass Correlation Coefficient(ICC) as statistical method.   "
86127|NCT02158689|"     The accurate identification and efficient management of poor responders remains one of the     most enigmatic challenges in assisted reproductive technology (ART). The investigators study     will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who     poor responders.   "
86128|NCT02158676|"     The study will recruit patients submitted to bariatric surgery. Individuals will be     supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days.     Immunological, metabolic and anthropometric parameters will be assessed before and after the     supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate     plasma concentrations of immunological and metabolic parameters and anthropometric measures     of subjects undergoing gastric bypass Roux-Y.   "
86129|NCT02158663|"     Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1     Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater     improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS     score. The secondary objectives include: one, testing which treatment provides a     significantly greater improvement in depressive symptoms as measured by change in QIDS score;     two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD     symptoms; and three, testing which treatment is better tolerated as measured by participant     drop out and side effect profiles.      Research Design: Randomized single-blind (raters) prospective clinical trial testing the     effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.      Methodology: Veterans 18 to 50 years of age suffering from PTSD with and without depressive     symptoms will be recruited from the community as well as from the mental health clinics at     the James A. Haley Veterans Administration Hospital. Plan to enroll 50 in order to have an     evaluable sample of approximately 20 in each group. Participants will be consented and     undergo screening for safety and appropriateness to be in the trial. Those deemed eligible     will be evaluated with clinical measures of function, PTSD, depression, pain, and     neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by     significant depression defined as MADRS greater than 19) to one of two active treatments:     right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo     assessment for safety prior to each treatment. The treatments will be performed 5 days a week     for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per     week. Clinical evaluations will be performed at baseline, after every five treatments, at the     end of the treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used     to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal     rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a     significant difference in change in depressive symptoms for both the participants with     significant depressive symptoms and the entire group. The number of dropouts (related     specifically to side effects and all cause) will be used along with side effect profiles to     test for differences in tolerability of the two treatments.   "
86130|NCT02158650|"     The purpose of this study is to determine if presenting treatment options to basal cell     carcinoma patients in video format will improve efficiency and allow patients to receive     consistent, comprehensive, visually-depicted treatment option information to improve patient     quality of care. Patients can learn more about treatment options as they are depicted     visually so as to better assist them in understanding treatment risks and benefits to     confidently make a well-informed decision. Primarily, the study will evaluate efficiency when     using the education video medium. The study will also evaluate the effectiveness of the video     medium as an aid to decision making in addition to standard of care in comparison to the     standard of care alone. Additionally, the study will evaluate both patients' and     dermatologists' satisfaction of the educational intervention.   "
86131|NCT02158637|"     This study is being done to try out questions from a large set of questions called the     Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events     (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms.     This study will look at properties of these questions and will provide information about how     these questions can be improved for research studies. PRO-CTCAE questions were developed     under a contract from the National Cancer Institute (NCI) to allow patients to self-report     symptoms in future cancer clinical trials. Patients with cancer receiving treatment will     complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet     containing a commonly used questionnaire for assessing quality of life, functioning, and     symptoms at two visits one to six weeks apart. Some patients will additionally complete     web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while     completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone     system. Lastly, a small number of patients will complete only a single visit in which a     web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is     completed in addition to a paper booklet containing a commonly used questionnaire for     assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores     for PRO-CTCAE questions will differ between patients with high versus low general well-being     as measured by your doctor using a scale called the Eastern Cooperative Oncology Group     Performance Score.   "
86132|NCT02158624|"     To establish the correlation between visual acuity improvement and QOL measurement after     ranibizumab treatment for AMD patients.   "
86133|NCT02158611|"     This project aims to provide more treatment options to suicide patients to further enhance     the holistic medical services in Far Eastern Memorial Hospital. It focuses on high-risk     cases, especially those whose suicidal behaviors are triggered by interpersonal/or emotional     problems because psychological counseling or interpersonal growth groups of services have     been shown to be beneficial to this population.   "
86134|NCT02158598|"     This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women     aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D     concentration following vitamin D supplementation with chewable tablets versus pills.     Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet     supplement. Questionnaires on physical activity, sunlight exposure and dairy product     consumption will be administered to adjust for confounding factors. A questionnaire will be     administered to assess satisfaction and pill count to evaluate adherence to treatment. This     research intends to test the hypothesis that the vitamin D chewable tablet supplement is as     effective as a traditional vitamin D pill supplement to increase serum 25(OH)D     concentrations.   "
86135|NCT02158585|"     This double-blinded study evaluates the frequency of vertigo attacks and the quality of life     of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo     or lamotrigine.   "
86136|NCT02158572|"     Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.   "
86137|NCT02158559|"     This study focused on the effect of Danhong injection on microcirculation in the treatment of     patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.   "
86138|NCT02158546|"     This study will evaluate the efficacy and safety of ALKS 5461.   "
86139|NCT02158533|"     This study will evaluate the efficacy and safety of ALKS 5461.   "
91260|NCT02091557|"     To assess the diagnostic accuracy for the noninvasive detection of pelvic endometriosis of     the combination of two simple parameters: modifications of serum CA 125 and VAS pain score     following one dose of GnRH-analog (GnRH-a).   "
86140|NCT02158520|"     This randomized phase II trial studies how well paclitaxel albumin-stabilized nanoparticle     formulation and bevacizumab or ipilimumab works as first-line therapy in treating patients     with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as     paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Bevacizumab may stop the growth of tumor cells by binding to a     protein called vascular endothelial growth factor (VEGF) and by preventing the growth of new     blood vessels that tumors need to grow. Ipilimumab blocks a substance called cytotoxic     T-lymphocyte-associated antigen-4 (CTLA4) on the surface of T cells and may help the immune     system kill cancer cells. It is not yet known whether paclitaxel albumin-stabilized     nanoparticle formulation and bevacizumab is more effective than ipilimumab in treating     melanoma.   "
86141|NCT02158507|"     This study will evaluate the effectiveness and safety of the combination of two drugs,     Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer     that have undergone previous treatment. Veliparib is an investigational drug and has not been     approved by the FDA while Lapatinib has been approved by the FDA for another type of breast     cancer. All eligible participants will receive the study medications and not a placebo.   "
86142|NCT02158494|"     The investigators hypothesis is that electrical stimulation to the tongue that directly     stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural     impulses to the brainstem and cerebellum. The investigators call this cranial nerve     non-invasive neuromodulation (CN-NINM). The activation of these structures induces     neuroplasticity when combined with specific physical, cognitive and/or mental exercises,     promoting recovery of selected functional damage such as problems with balance or walking.      44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training     followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of     the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use     very low level stimulation in conjunction with the exercise, and will serve as a control     group.   "
86143|NCT02158481|"     The main aim of the study is to investigate the effects of dietary ingredients (polyphenols     and carotenoids) on vascular function during acute glucose load. Each subject will receive 4     weeks of intervention with test product or placebo product after a dietary restriction run-in     period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT)     immediately after the run-in phase and at the end of the intervention phase. During the OGTT,     blood samples will be taken at regular intervals.      The study will be conducted in subjects with impaired glucose tolerance.   "
86906|NCT02148523|"     To assess the effectiveness of social comparison in improving the outcome of statin adherence     versus usual care as measured by an electronic pill bottle.      Subjects receiving weekly reports with their adherence and information about their place in     the distribution of their peers will have the highest statin adherence of any arm, as     measured by electronic pill bottle.   "
86145|NCT02158455|"     The investigators have developed a novel technique for saphenous vein graft harvesting for     coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of     surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein     grafts harvested with this new methode compared to conventional harvesting technique 8.5     years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized     trial comparing patency between vein grafts harvested with surrounding tissue and radial     artery grafts. The result showed that vein grafts harvested with surrounding tissue had a     significantly higher patency rate compared to radial artery grafts 3 years after surgery (98     vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in     the second randomized trial. The hypothesis is that vein grafts harvested with surrounding     tissue have a significantly higher patency rate compared to radial artery grafts 8 years     after surgery.   "
86146|NCT02158442|"     The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing     antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes     who have a significant lower limb infection and it is deemed that IV antibiotics are needed     in order to salvage the limb or life.   "
86147|NCT02158429|"     1. A randomized trial of 3-dimensional vs. 2-dimensional ultrasound, comparing scores on          the Maternal Antenatal Attachment Scale (MAAS), a validated instrument measuring          maternal attachment as a marker of maternal bonding. The hypothesis is that          3-dimensional ultrasound is better at eliciting maternal attachment than 2-D        2. To assess changes in maternal confidence to stop using drugs and quit/reduce smoking          with 3-D vs. 2-D ultrasound. Again, the hypothesis is that 3-D ultrasound will improve          the woman's confidence to stop using substances.        3. To evaluate if 3-D ultrasound improves paternal attachment as measured by pre- and post-          scores on the Paternal Antenatal Attachment Scale (PAAS). The hypothesis is that 3-D          ultrasound will have a greater effect on PAAS scores than 2-D.   "
86148|NCT02158416|"     The planned minimal risk study is a blinded study on consecutive transfusable platelet     products. The aim of the study is to evaluate the quality of platelet components sampled     prior to transfusion.      The primary patient transfusion outcome in this study is the 1-hour corrected count increment     (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be     sampled for ThromboLUX testing before being sent from the blood bank to the treatment center.     After receipt at the treatment center, the platelet products will be used as per regular     clinical practice, and the outcome data from each patient will be collected. At the end of     the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX     Score is associated with a poor transfusion outcome.      During the course of the study, the TLX Score will not be known to the clinicians, or     utilized in any way to decide if the platelet product should be transfused.   "
86149|NCT02158403|"     The purpose of this study is to assess how often blood clots form in the FDA-approved     HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to     clotting within the pump.   "
86277|NCT02156739|"     The goal of this clinical research study is to learn if using 2 different kinds of contrast     agents (Eovist [gadoxetate] and Gadovist [gadobutrol]) given at the same time is better than     using 1 contrast agent alone in learning which liver lesions may be cancerous.      Contrast agents are used by doctors in order to see MRI images more clearly.   "
86150|NCT02158390|"     Children with Down syndrome (DS) have greater difficulty acquiring expressive language than     is predicted by their general cognitive abilities and language comprehension (Miller, 1999).     To date, interventions to improve communication outcomes for children with DS have met with     only modest success. The proposed study is a randomized controlled trial of an early     communication intervention combining two evidence-based treatments that teach expressive     communication (Enhanced Milieu Teaching; EMT) and joint attention/symbolic play (Joint     Attention Symbolic Play Engagement and Regulation; JASPER) using a dual mode (words +AAC).     The intervention (a) teaches the foundations of communication (joint attention, play), (b)     builds on positive child characteristics of social attention, (c) uses naturalistic     strategies to increase the rate and complexity of communication and increase task engagement,     (d) addresses the potential value of adding visual support (AAC) to spoken communication, and     (e) includes parents as implementers of the intervention to promote generalization across     settings and activities, and to ensure maintenance over time. It is hypothesized that     children with DS enrolled in the intervention will have better language and communication     skills at the end of treatment and followup than children in the BAU comparison group.The     study will enroll 82 30 to 54 month old children with DS who have fewer than 20 words.     Examining predictors of response to treatment and the effects of treatment on executive     functioning will inform both theory and practice.   "
86151|NCT02158377|"     Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent     (TSV) dental implants loaded early in maxillary and mandibular sites.   "
86152|NCT02158364|"     The purpose of this survey is to assess the safety of freeze-dried live attenuated measles     and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live     attenuated measles and rubella combined vaccine Takeda) in terms of the occurrence of     unknown/known adverse drug reactions and factors that may influence the safety of vaccinees     after the second vaccination.   "
86153|NCT02158351|"     Several experimental data suggest that gut-derived endotoxin and GM composition can act as a     second hit or insult to convert hepatic SS to NASH and cause both local hepatic and     systemic inflammation.This study's aim is to analyze microbiota diversity, providing     information both on intestinal microbial composition and on the metabolic processes linked to     them. In addition, we will correlate, for the first time, GM composition to hepatic and white     adipose tissue gene expression patterns of interest and serum and fecal markers possibly     related to impaired fat storage and inflammation. We aim to provide preliminary data to     design future intervention studies with pre- or probiotics or bile acid derivatives to     prevent/treat inflammation and fibrosis in NAFLD patients.   "
86165|NCT02158195|"     The aim of this study is to compare different blood cells of the immune response in patients     with Autoimmune Hemolytic Anemia and healthy subjects.      Evaluate the impact of treatments, notably corticoids, on blood cells of the immune response.      Better understanding of the mechanisms involved in the course of this disease could lead to     new treatments.      12 patients with Autoimmune Hemolytic Anemia will be compared with 12 controls matched for     sex and age.      Controls will provide blood samples only once. The will have no particular follow-up.      Patients will provide blood samples at the time of diagnosis then 3 months after the start of     treatment. If a new treatment needs to be started before the end of the 3-month period, a new     blood sample will be taken.   "
86154|NCT02158338|"     Six studies have preceded this project. Three studies suggested that there is a significant     connection between pediatric asthma and disruptions in maternal-infant bonding (Feinberg,     1988; Schwartz, 1988; Pennington, 1991). Three studies suggested that children with asthma     benefit from a type of therapy that improves bonding with their mothers (Madrid, Ames,     Skolek, & Brown, 2000; Madrid, Ames, Horner, Brown, & Navarrette, 2004; Madrid, Pennington,     Brown & Wolfe, 2011).      This study proposes to study in a more thorough fashion the question of the incidence of     bonding disruptions with between mothers and their children with asthma. This time there will     be a larger sample, and more stringent criteria will used in assigning children to the asthma     cohort. Through questions answered by mothers whose children have been said to have asthma,     we will be able to decide if the children's respiratory conditions are likely to be     attributable to asthma or more likely reflective of another respiratory condition such as     vocal cord dysfunction or anxiety related hyperventilation (Anbar, 2014).   "
86155|NCT02158325|"     Different capsulorhexis size results in different capsular outcome when treating pediatric     cataract, and there should be an appropriate capsulorhexis size for the best capsular     outcome.   "
86156|NCT02158312|"     Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor     circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to enhance     after-effects of rehabilitation through membrane polarization modulation. In this     double-blind, crossover randomized controlled trial, we aim to investigate whether     single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper     extremity rehabilitation therapy modulates ipsilesional motor circuit excitability using     transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.   "
86157|NCT02158299|"     After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma     formation and it can not be ignored.Investigators aimed to study two new methods of     application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation     and to verify the efficacy and safety of these two applications.Try to prove them as     beneficial supplements for axillary lymphadenectomy of breast cancer.   "
86158|NCT02158286|"     Retention of the gastric tube after esophagectomy is a clinically important problem, and     there is a need of a simple method to evaluate emptying rate from the gastric tube after     esophagectomy. Scintigraphy is the golden standard of measuring emptying rate from the     gastric tube. In non-operated patients, paracetamol clearance technique have been widely used     for measuring gastric emptying rate. There is no validation however if paracetamol clearance     technique can be used for measuring emptying rate of the gastric tube. The investigators aim     of this pilot- study is to validate paracetamol clearance technique to scintigraphy for     measuring emptying rate from the gastric tube and to evaluate if there is a correlation     between symptoms of retention and quality of life with the emptying rate.   "
86159|NCT02158273|"     The primary hypotheses under test are that alcohol dependent subjects treated with     fenofibrate will report decreased craving for alcohol following cue-exposure in the     laboratory and report less drinking post treatment relative to placebo.   "
86161|NCT02158247|"     1. Airway length from the medial incisor to carina is divided into four segments ; the          length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to          vocal cords and vocal cords to carina.        2. Determining the mean length of each segments with the direct laryngoscope,          videolaryngoscope and fiberoptic bronchoscope at the time of endotracheal intubation.        3. Making a new formula to determine the proper individualized depth of intubation on the          basis of the length of segments        4. Virtual experiment : comparing the new formula with conventional method of determining          the depth of endotracheal intubation   "
86162|NCT02158234|"     This study involves another course of radiation (called re-irradiation) to the participant's     tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The     purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT     given along with the chemotherapy drug, cisplatin. The researchers want to see which dose of     radiation will work best in controlling the growth of head/neck cancer. The usual treatment     for head/neck cancer that has grown is surgery and/or more radiation with various     chemotherapy drugs.   "
86163|NCT02158221|"     The investigators hypothesized that migraine without patients with many genetic loci     associated with migraine (high genetic load) would be more sensitive and get provoked more     migraine attacks by PACAP compared to patients with few genetic loci associated with migraine     (low genetic load).   "
86164|NCT02158208|"     The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of     Horton's disease.      At the inclusion visit, patients will have, as is the case in the usual strategy:        -  A complete clinical examination carried out by the doctor in charge of the patient        -  ESR, and CRP and fibrinogen assay        -  A full blood count for leukocytes and lymphocytes        -  A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting          Horton's disease. The clinician in charge of the patient will decide if a second biopsy          is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological          cytology service. Immunohistochemical analyses will be done if the TAB is positive.      In addition to the standard clinical examination and complementary examinations relative to     the patients' pathology, the following will be done:        -  Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4)          and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it          possible to calculate the absolute value for different T lymphocyte populations.        -  A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which          will be stored at -80°C for future assays for cytokines and other biomarkers of interest          for Horton's disease.        -  16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used          immediately for cytometric and functional analyses.   "
86166|NCT02158182|"     The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and     rifaximin are effective in the prevention of the development of hepatic encephalopathy in     cirrhotic patients with acute variceal bleeding   "
86170|NCT02158130|"     The proposed study seeks to better understand the role of body weight, energy expenditure,     and energy intake as mechanisms of body weight gain during detraining following aerobic     exercise. It is hypothesized that participants in the higher dose exercise group will have     greater body weight gain compared to the lower exercise dose and control group from wk 24 to     wk 76 follow-up.   "
86171|NCT02158117|"     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least     in Norway. The annual death toll from overdose is about 250, twice the annual death toll from     traffic accidents. Those who inject heroin or other opioids are considered to have the     highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid     antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood     vessel. Administration of naloxone via the nose has been suggested as an alternative for use     by emergency teams and possibly also bystanders. This is not only an easier way to give     naloxone, but would also eliminate the risk for needle stick injuries and blood     contamination. A pilot study in this hospital has shown no significant side effects or     adverse reaction. While significant benefits are expected from developing an adequately     formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal.     Therefore this preclinical study in healthy volunteers will be undertaken.   "
86172|NCT02158104|"     Pain after dry needling or injection in the muscle is a frequent secondary effect in the     treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed     during a 72 hours follow up period. Factors that may contribute to higher levels of pain or     sensitivity will be evaluated.   "
86173|NCT02158091|"     This research study is evaluating a new drug called IPI-145 in combination with the standard     drugs fludarabine, cyclophosphamide, and rituximab (FCR), as a possible treatment for chronic     lymphocytic leukemia (CLL).   "
86174|NCT02158078|"     The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported     outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2     diabetes mellitus (T2DM).   "
86175|NCT02158065|"     The purpose of this 3 month randomized intervention study is to investigate the additional     effect of a physical activity telecoaching program on physical activity in patients with     COPD, compared with usual care.   "
86176|NCT02158052|"     This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or     systemic AL amyloidosis for which hematopoietic stem cell transplantation would be ordinarily     indicated and the reversal of end-stage renal failure, while avoiding the risks associated     with long-term standard anti-rejection therapy used in renal transplantation. The primary     objectives of this study are to assess renal allograft tolerance (that is, the acceptance of     the kidney without the need for anti-rejection therapy), assess anti-tumor response rates in     multiple myeloma and AL amyloidosis, and assess complication rates for genetically (HLA)     matched related donor combined bone marrow and kidney transplantation using a low dose total     body irradiation based preparative regimen.   "
86329|NCT02156063|"     This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous     NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately     150 participants will be randomised to receive subcutaneous NT100 or placebo.   "
86177|NCT02158039|"     Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical     removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol)     injection may treat cysts by killing the lining cells of the cyst, and is an accepted     treatment for cysts of other organs. In this study, participants with pancreatic cysts     underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was     a pilot study to assess safety and efficacy.      The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring     hospitalization will occur in <10% of subjects, and 2) EUS guided ethanol injection, with     retreatment as necessary, will ablate at least 50% of pancreatic cysts.   "
86178|NCT02158026|"     1000 women with infertility who are already decided to be treated with ICSI will be subjected     to full history taking and clinical examination. On the second day of menstruation serum FSH,     LH, Prolactin and Oestradiol will be assessed and the antral follicular count (AFC) will be     assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles     measuring 3-10mm.      All patients will have standard pituitary down-regulation followed by (Human menopausal     gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG)     administration. On the day of HCG administration, ovarian ultrasound scan will be performed     using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC)     is defined as number of follicles measuring≥16mm. Follicular sensitivity index (FSI) will be     calculated as: (FSI =PFC*10000/AFC*Total dose of FSH)   "
86179|NCT02158013|"     The purpose of this study is to investigate the effect of Levorag Emulgel compared with     diltiazem gel on the healing of chronic anal fissures.   "
86180|NCT02158000|"     To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in     cases undergoing intracytoplasmic sperm injection (ICSI) cycles.   "
86181|NCT02157987|"     Epistaxis are present in over 90 % of patients with Rendu - Osler . They involve no     significant difference 2 sexes. They often appear in childhood and adolescence and are     present in three-quarters of patients at the age of 20 years. These epistaxis increasing in     frequency and volume to the age of 60 in 2/3 of patients. Epistaxis are spontaneous ,     repetitive and recurring . They are highly variable in duration, intensity and frequency of     occurrence . Some patients may have more than 40 monthly episodes with mean duration of 5     minutes of bleeding and chronic anemia and can sometimes acute anemia with transfusions need     to be source. These epistaxis stigmatize patients and inevitably affect their quality of life     and social skills . The various proposed ( cauterization , intra- mucosal injections, laser     selective hémostatses , embolization or surgical dermoplasties ) allow for some short-term     remissions . Bevacizumab is an antiangiogenic use in the treatment of colorectal cancers . It     is also used in ophthalmology intravitreal to reduce vascular proliferation in glaucoma     retinopathy and certain corneal neovascularization. In 2009, Prithviraj reported the use of     bevacizumab injection to treat pulmonary arteriovenous malformations in a patient with Rendu     - Osler . The result is doubly interesting including a saving action on epistaxis which     decrease in frequency and duration. This communication prompted the authors to focus more on     this medication. The product has been used in local submucosal injection intranasal laser was     coupled with satisfactory results objectified by a decrease in the number of epistaxis ,     reducing blood transfusions and improved social lives. The use of local instillation     bevacuzimab represents a way forward for the treatment of these epistaxis.   "
86183|NCT02157961|"     This is an observational study to assess the health behavior of Physicians from medical     practices in Germany. Physicians will be asked by a questionnaire (self-report) on health     behavior, self-diagnostics and self-medication in case of sickness. We will send the     questionnaire to 1000 General Practitioners and to 300 medical specialists in Germany. We     expect a response rate of 25-30 %. After electronically data-entry we will run a descriptive     analysis for primary outcome. Results may provide a better understanding of the Physicians     health behavior.   "
86184|NCT02157948|"     This study will compare the effect of denosumab produced by two different manufacturing     processes on bone mineral density at the lumbar spine in postmenopausal women with     osteoporosis.   "
86185|NCT02157935|"     Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations     in patients with Chronic Obstructive Pulmonary Disease (COPD).   "
86186|NCT02157922|"     The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder     formulation, in adult subjects with cystic fibrosis.   "
86187|NCT02157909|"     The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere     modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit     by comparing the percent of subjects satisfying the no re-fit criteria in each treatment     group.   "
86188|NCT02157896|"     Vascular endothelial growth factor (VEGF) and Endostatin (ES) participate angiogenesis after     cerebral ischemia. Circulating endothelial progenitor cells (EPCs) also play a crucial role     in neovascularization and tissue repair after acute ischemic stroke (AIS). The investigators     sought to compare the expression of VEGF and ES in serum and the circulating EPCs in patients     after AIS with that of healthy control subjects. The investigators obtained peripheral blood     and serum samples from study subjects. EPCs in blood samples from AIS patients and healthy     controls were quantified by flow cytometry 1 day, 3 days, 5 days and 7 days after AIS. VEGF     and ES were measured by enzyme linked immunosorbent assay at the same time points. The     relation between them and the relation of them to prognosis of such patients with acute     ischemic stroke were assessed.   "
86189|NCT02157883|"     This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose     disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy.     Part A will assess the effect of multiple oral doses of itraconazole on the single dose     pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to     take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if     they and the Investigator deem it appropriate, until such time as their disease progresses,     the Investigator believes they are no longer deriving clinical benefit, or they stop taking     AZD9291 for any other reason.   "
87437|NCT02141581|"     The purpose of this study is to investigate the responses to licensed trivalent, inactivated     influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal     (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all     given to generally healthy male and female adult volunteers.   "
86190|NCT02157870|"     Multi-Phase study (I/II) that did not progress to Phase II of clinical trial, terminated     early due to low accrual, separate ClinicalTrials.gov Registration NCT00102622 for Phase I of     study:      Phase I:        -  Enrollment of up to 24 subjects in 8 cohorts of three subjects to one of three          combinations of intraperitoneal (IP) tgDCC-E1A + intravenous (IV) paclitaxel by the          continuous reassessment method (CRM) will be sufficient to establish the MTD        -  The single agent paclitaxel cohort will consist of 24 subjects      Phase II:        -  Enrollment of up to 20 subjects to one of three combinations of IP tgDCC-E1A + IV          paclitaxel decided by Phase I.        -  The single-agent paclitaxel cohort will consist of 20 subjects.   "
86191|NCT02157857|"     The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect     lymph node metastases in lung cancer patients using EBUS-TBNA samples.   "
86192|NCT02157844|"     Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by an     obstruction of the upper airways. The obstruction results in periods of intermittent hypoxia     and re-oxygenation, which lead to increased oxidative stress, increased inflammation,     endothelial dysfunction, and insulin resistance. Chronic obstructive pulmonary disease (COPD)     is a lung disease that leads to poor airflow. This disease leads to systemic hypoxia, reduced     oxidative capacity, and increased inflammation. The direct cause of OSA and COPD is unclear,     but OSA and COPD may be linked to other comorbid conditions such as obesity and type II     diabetes. Upon onset of OSA and COPD, metabolic disturbances associated with obesity and type     II diabetes can be exacerbated.      Obesity is a condition characterized by an increase in visceral fat, elevated plasma levels     of free fatty acids, inflammation, and insulin resistance. Although the effects of body fat     distribution have not been studied in these patients, an increase in both subcutaneous and     abdominal fat mass in non-OSA older women was shown to increase morbidity and mortality.     Fat/adipose tissue is an active tissue capable of secreting proinflammatory cytokines such as     tumor necrosis factor (TNF)-alpha and interleukin (IL)-6, reactive oxygen species and     adipokines. Particularly, abdominal fat is a prominent source of pro-inflammatory cytokines,     which contributes to a low grade, chronic inflammatory state in these patients. Additionally,     an increased inflammatory state is associated with reduced lean body mass, and together with     elevated circulating free fatty acids may increase the occurrence of lipotoxicity and insulin     resistance. Thus, increased fat deposition is associated with a poor prognosis in OSA and     COPD patients and therefore it is of clinical and scientific importance to understand the     changes in fat metabolism and digestion as a result of OSA and COPD.      It is therefore our hypothesis that fat synthesis and insulin resistance is increased and     whole body protein synthesis is decreased in OSA and COPD patients, leading to a poor     prognosis.   "
86193|NCT02157831|"     Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC     10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC     10903 intravenously.   "
86204|NCT02157688|"     The folliculitis decalvans (FD) is an orphan disease , common in consultation specialized on     scalp. This disease is currently not curable, responsible for significant for patients. The     pathophysiology is poorly understood, Staphylococcus aureus (SA) appears to play a role,     never previously studied, and the study will attempt to clarify it.      Controversies in the literature on the pathophysiological hypotheses can be summed up as     follows :      FD is it an infectious folliculitis where SA (almost always found on the lesions plays a     direct role possibly aided by a lack of local immune protection , or is it a pustular     inflammatory unknown cause where the SA has no direct role but is a cofactor or a simple germ     superinfection.      Our study has plans to bring new evidence to help decide between these two opposite but not     mutually exclusive concepts .   "
86194|NCT02157818|"     1. Appropriate sedation is needed for medical diagnosis, treatment, and the safety for          patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated          status for patients.             -  However, especially in bronchoscope procedure, continuous monitoring of oxygen               saturation is needed to prevent hypoxia due to respiratory distress induced by               benzodiazepine.             -  A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has less               adverse effect of respiratory distress compared to previous agents, was introduced.        2. It is necessary to compare the efficacy and safety of dexmedetomidine with that of          midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).             -  Double blind randomized trial             -  Primary outcome: The number and duration of desaturation, volume of sedative, any               use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and               hypertension, tachycardia, any need for mandible support or manual ventilation, and               any need for intubation (for safety).   "
86195|NCT02157805|"     This project aims to assess the impact of technological processes of meat, as cooking     conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that,     even if meat is considered as a good provider of fast proteins and so could be useful to     prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and     amino acids bioavailability for muscle synthesis.   "
86196|NCT02157792|"     An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of     VX-970 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors   "
86197|NCT02157779|"     Excessive and poorly controlled anger is one of the most common problems experienced by war     Veterans. The consequences can be severe, including increased risk for divorce, domestic     violence, job loss and instability, and other serious impairments in family, social, and     occupational functioning. Availability of effective treatments is critical to reducing the     adverse effects of anger in Veterans. The investigators propose to conduct a controlled study     to determine whether a cognitive behavior treatment that has been adapted for treating anger     problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a     supportive therapy. Results will be examined for improvement in anger, functioning, and     quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.   "
86209|NCT02157623|"     The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic     Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell     carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved     method widely used currently for squamous precancers of the skin. The investigators     hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is     nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study     will investigate whether there are any differences in tumor clearance between the Blu-U®     (blue lamp) and Aktilite™(red lamp) therapies.   "
86210|NCT02157610|"     The goal of this research study is to compare a program called Motivation And Problem-Solving     (MAPS) to the standard treatment to help participants with a history of cervical cancer to     quit smoking.   "
87438|NCT02141568|"     The purpose of this study is to check the medical efficacy and economic benefits of     multidisciplinary care in patients with unexplained medical complaints and consume medical     services frequently.   "
86198|NCT02157766|"     The Wisconsin Center for the Neuroscience and Psychophysiology of Meditation will be a highly     focused center dedicated to novel and cutting edge research on the mechanisms by which     meditation works. The core set of hypotheses for this Center focus on the mechanisms of two     common meditation practices: Mindfulness Meditation (MM) and Loving-Kindness/Compassion     Meditation (LKM-CO), both taught in Mindfulness-Based Stress Reduction (MBSR). The     investigators will study both Long-Term Meditators (LTMs) as well as meditation-naïve     participants (MNPs). The latter group will be randomly assigned to MBSR, a rigorously matched     comparison intervention called the Health Enhancement Program (HEP; MacCoon et al., 2012), or     to a Wait List (WL) control group. This will give us a comprehensive view of changes that are     produced by meditation practices per se, changes generically associated with interventions     designed to promote well-being, and changes that might be effects of repeating testing     protocols across multiple occasions. In addition, the inclusion of both novice and     experienced meditators provides a wide range of practice experience that will provide     critical information on dose-related effects, information that is lacking in the research     literature today.      Each of the projects is focused on examining the brain mechanisms and peripheral biological     correlates of meditation. Project 1 (Davidson) will examine the impact of the explicit use of     mindfulness and loving-kindness/compassion strategies on emotion regulation, specifically     neural, biobehavioral and hormonal indices of reactivity to and recovery from pictures of     human suffering and flourishing. Project 2 (Busse) will investigate the brain to periphery     pathways through which psychological factors contribute to the expression of asthma symptoms.     In addition, it will examine the efficacy of meditation training in reducing the inflammatory     response to an allergen in asthmatic individuals by reducing the reactivity of     emotion-related neural circuitry. Project 3 (Tononi) will examine whether the previously     reported increase in gamma oscillations during Non-REM (NREM) sleep in meditators is     associated with changes in sleep mentation (Ferrarelli et al. 2013). In addition, project 3     will examine relations between meditation-induced changes in brain activity during sleep and     brain activity and cognitive function during wakefulness.   "
86199|NCT02157753|"     As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after     about 500 fracture patients hospitalized with an age over 50 years a year. First, we were     interested in the effective rate of osteoporotic fractures in this cohort. As to this     objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a     diagnostic pathway for every patient over 50 years of age with a fracture, including dual     energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning osteoporosis     and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a laboratory workup     focusing on this topic. Considering all these information we sent a detailed therapy-plan to     the responsible General practitioner.      The main goal of this study is to verify the persistence and compliance of the osteoporosis     therapy 12-15 months after fracture and to clarify any obstacles potentially impeding therapy     (prejudice, adverse events, contraindication overlooked, financial problems etc.). The     investigators use a postal questionnaire provided to the patient and the general     practitioner. Data collection is undertaken by a study nurse, in addition phoning for missing     data by phone-call. With the aim to ameliorate the implementation of treatment, patients and     general practitioners will be provided with the specifically tailored information found to be     missing.   "
86200|NCT02157740|"     The purpose of this study is to determine whether teleconsulting would be effective and     cost-effective by reducing the patients transportations and the use of emergency units for     nursing home residents requiring emergent or elective care.   "
86201|NCT02157727|"     The purpose of this study is to determine whether telemedicine would be as effective as     having a pediatrics ophthalmologist on site for screening examination of retinopathy in     premature infants and would be cost-effective.   "
86202|NCT02157714|"     This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and     immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.   "
86203|NCT02157701|"     This is a multicenter, randomized, double-blind, placebo-controlled, study in subjects with     exercise-related knee pain/discomfort to determine the efficacy of a polyherbal capsule     compared to placebo capsule in improving exercise capacity and overall parameters of joint     health.   "
86205|NCT02157675|"     This study is a randomized, double-blind, placebo-controlled, crossover design study in     healthy subjects to determine the effects of a polyherbal supplement on the signs and     symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm.   "
90234|NCT02104973|"     The purpose of this study is to design, implement and evaluate an intervention oriented to     change alimentary practices and patterns of physical activity of children through educative     activities with parents, teachers and children in school of Mexico city.   "
86206|NCT02157662|"     The risk of developing clinical manifestations of ischemic heart disease is currently     assessed by using integrated multifactorial prediction models based on the presence of     non-modifiable risk factors, such as age, gender and a family history of early ischemic heart     disease along with risk factors which are defined as conventional, such as arterial     hypertension, hypercholesterolemia, cigarette smoking and diabetes mellitus.      However, if the relationship between risk factors and ischemic heart disease clinical     manifestations shows some limitations, the relation between risk factors and the coronary     atherosclerosis process underlying most ischemic syndromes seems to be even weaker.      In fact there is significant individual variability and the limits of such relationship are     demonstrated by a non negligible number of subjects at the outliers of mean behaviour of the     prediction model. At one outlier, in the presence of multiple risk factors, these subjects do     not develop neither coronary events nor coronary atherosclerosis whereas, at the other,     coronary events and disease occur in the absence of risk factors.This study aims at detecting     new protection and susceptibility factors, thus enabling to formulate new etiopathogenetic     hypotheses concerning coronary atherosclerosis and to identify new therapeutic targets.   "
86207|NCT02157649|"     The objectives of this study are (a) to determine if drug levels from a single dose of an     extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given     every four hours containing lower doses considered safe for over-the-counter use; (b) to     evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet     after a single administration; and (c) to assess the safety and tolerability of the     Codeine/Guaifenesin extended-release and immediate release tablet formulations.   "
86208|NCT02157636|"     Open-label, sequential dose escalation and expansion study of CPI-0610 in patients with     previously treated multiple myeloma. CPI-0610 is a small molecule inhibitor of bromodomain     and extra-terminal (BET) proteins.   "
86230|NCT02157350|"     The purpose of this study is to determine the threshold level of proliferative diabetic     retinopathy progression and regression after standard panretinal photocoagulation. Predictors     of progression and regression will be identified which will include retinal vessel geometry     (caliber, fractals and tortuosity), retinal vessel oxygen saturation and retinal areas of     non-perfusion.   "
86211|NCT02157597|"     Heart surgery in young children involves some risks. This study looks at a new type of     monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to     measure if enough blood reaches vital organs in the body. The investigators goal is to see if     this shows problems developing sooner than usual. The investigators do not know at this time     if they can improve the blood supply to the vital organs. The investigators main aim is to     see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug     Administration (FDA).      The investigators will also follow the progress of recovery after surgery in the Cardiac     Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome     for children.   "
86212|NCT02157584|"     This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of     telotristat ethyl and its metabolite LP-778902 relative to administration of single dose     telotristat etiprate in the fasted state in healthy adult male and female subjects.   "
86213|NCT02157571|"     The purpose of this study is to use oral prulifloxacin to treat patient with Acute     Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.   "
86214|NCT02157558|"     The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the     pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.   "
86215|NCT02157545|"     Pyridostigmine is a medication that is used in certain heart rate and blood pressure     conditions. This medication, as a side effect, is known to also cause changes in the junction     between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine     could alter the effect of muscle relaxants (a medication used during surgery and anesthesia).     The investigators are conducting this study to see whether patients taking pyridostigmine are     more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).   "
86216|NCT02157532|"     Stroke constitutes the primary cause of acquired disability in adults and the second cause of     dementia following Alzheimer disease. It has been shown that patients with a moderate to     severe clinical score have occlusion of brain large vessels, resulting in a worse clinical     outcome. Many studies have demonstrated that early recanalization after IV rtPA is more     restricted, the larger and more proximal the artery. Several systems for mechanical     intracranial arterial thrombectomy of large trunks have recently been proposed and are now     available. Potential advantages of these mechanical systems on chemical thrombolysis are     speed (a few minutes versus 1 hour) and absence of thrombolytic injection.      The objective of the EASI trial is thus to:        -  To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in          patients treated with IV thrombolysis or in patients for whom thrombolysis is          contra-indicated.        -  To determine whether a combined approach, standard treatment plus thrombectomy, is          superior to standard treatment alone within 5 h of the appearance of symptoms, in          patients with occlusion of proximal cerebral arteries following moderate to severe          stroke (NIHSS larger than or equal to 8), evaluated at 3 months.      The design is a randomized, controlled multicentric trial, with a parallel comparison between     standard and combined (standard plus thrombectomy) treatment.      480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary     hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal     to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3     months.      IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is     carried out with already approved devices, according to the manufacturer's instructions,     following a diagnostic cerebral angiography.      The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3     months.      The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage     at 24 hours.      If the primary hypothesis is validated, expected benefits of this study is a higher rate of     autonomy for stroke patients with all the attendant consequences: reduction in hospital     stays, and a faster return to the activities of daily life.   "
86226|NCT02157402|"     Our hypothesis is that healthy lifestyles improvement by an intervention designed according 8     social marketing Benchmark criteria, can reduce overweight or obesity implemented by     adolescents on their colleges.      The general aim of EYTO program is to improve health and well-being among adolescents who     live in low socioeconomically communities, through an intervention study designed by selected     adolescents with the inclusion of social marketing Benchmark criteria.   "
86217|NCT02157519|"     Many people treated for cancer receive oral chemotherapy medications for their illness. This     means that much of their cancer care occurs at home, away from a traditional oncology care     setting. The purpose of this study is to explore how a Smartphone mobile application (mobile     app) can help improve the cancer treatment process in people who are prescribed oral     chemotherapy medication. The investigators will explore how well the mobile app helps     patients stay connected with their oncology care team, take their oral medications as     prescribed, and manage their cancer-related symptoms from home. This study will be done in     two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention,     and 2) a randomized-controlled trial to test the intervention.   "
86218|NCT02157506|"     A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of     CXL-1427 in hospitalized patients with systolic heart failure.   "
86219|NCT02157493|"     This study will use a randomized controlled design to evaluate whether a youth     entrepreneurship/life-skills intervention for reservation-based American Indian adolescents     (ages 13-15) improves psychosocial, behavioral health, educational, and economic outcomes     from baseline for up to 3 years follow-up as compared to a recreational sports league control     condition.   "
86220|NCT02157480|"     Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the     cornerstone treatment for patients with T2D who are often overweight and sedentary.      Physical activity improves glucose metabolism of patients with T2D : increased glucose     utilization during acute muscle activity and improved insulin sensitivity after regular     training. The molecular mechanism underlying the effects of exercise on glucose metabolism     involves the glucose transporter GLUT-4 which is regulated by physical activity.      Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on     average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality     through physical activity.      Recent recommendations for T2D management call for the practice of a structured type of     endurance 150 minutes per week and muscle building 2 times per week. However, implementation     of these recommendations is low, even when integrated into a therapeutic education program.     Adherence is often transient and / or partial. In addition, many T2D subjects are unable to     initiate a physical activity because of disabling complications or comorbidities or because     of a major cardiorespiratory deconditioning.      Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional     rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been     little studied. A pilot study conducted by our team on a population of 18 subjects with T2D     showed that a week of daily NMES sessions significantly improved insulin sensitivity of about     25% and up to 50 % for good responders. This result contrasted with the low induced energy     expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of     a humoral or neural mechanism associated with NMES.      To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without     NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES     per week) to assess the glucose profile of sedentary T2D subjects during these different     periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D     subjects and thus represent an alternative to traditional physical activity.   "
86221|NCT02157467|"     The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of     coadministered oral contraceptives.   "
86222|NCT02157454|"     Being diagnosed with cancer confronts patients with a severe disease and they need to learn     to deal with a range of new challenges. In order to support patients in the coping process,     the website www.krankheitserfahrungen.de provides patients free, reliable information about     health issues by sharing peoples' real-life experiences. In our project, the investigators     developed a new module on the website for patients with colorectal cancer.      The objective of our study is to evaluate if access to the new colorectal cancer module on     the website www.krankheitserfahrungen.de increases patient's competence.      The investigators will conduct a two-arm randomized controlled trial. Patients affected by     colorectal cancer will be randomized into an intervention and a control group: the     intervention group will have access for two weeks to the website www.krankheitserfahrungen.de     (colorectal cancer module) with cancer patients´ experiences. Patients in the control group     will not receive any intervention but will have access to the website for two weeks after     completing the study.      Patient competence is measured by the self-efficacy component of the German short form of the     Cancer Behavior Inventory via an online questionnaire at baseline and after two weeks. A     second follow-up assessment will be implemented six weeks after baseline.   "
86223|NCT02157441|"     Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral     uterine artery ligation and compression of the lower uterine segment at the same time with     one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage     in women with placenta previa complete centralis. Method: This prospective study of 50 women     with postpartum hemorrhage following removal of placenta previa complete centralis during     elective cesarean section. All 50 patients will have lower uterine compression sutures     (involving bilateral uterine artery ligation and compression of the lower uterine segment at     the same time with one circular stitch). All patients will be followed postpartum for     evaluation of uterine cavity and menstrual cycles   "
86224|NCT02157428|"     Background and objectives: The inhalational anesthetic isoflurane is widely used in general     anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino     butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil,     benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could     therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early     anesthetic recovery reduce morbidity and incidence of complications. The objective of this     trial is to determine whether the use of flumazenil may contribute to faster recovery from     anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were     enrolled in this prospective, double-blind, randomized trial. Patients were randomized to     receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The     anesthetic technique was standardized. The groups were compared concerning values of Cerebral     State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of     flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation,     time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10)     was also collected. ANOVA test was applied to analyze the results, considering p <0.05.   "
86225|NCT02157415|"     It is the first clinical study aimed at assessing the safety and tolerability of UT-P as     routine rinsing and bacterial decolonization solution device for urinary catheters. The study     will be conducted in hospitalized adult patients who had an urethral or suprapubic catheter     in place for longer than two consecutive weeks and who are able to provide written consent.      This is an open-label prospective observational cohort study. No comparative control group is     planned as no other preventing infection solution is commercially available at this time.   "
86227|NCT02157389|"     Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological     rather than psychological interventions. Moreover, only few studies examined patients or     tested how previous experience and attitudes affect placebo and nocebo responses. On the     psychological level expectancy and classical conditioning have been identified as two primary     mechanisms. Both seem to be important with classical conditioning potentially having more     long-term effects and expectancy being more important in nocebo effects. There is some     initial evidence from the investigators own research that patients may be more prone to these     effects and the investigators have also shown that placebo effects may last up to several     years after treatment. The investigators therefore examine previous attitudes to     pharmacological interventions for chronic pain in patients with chronic back pain and     subdivide them into groups with high of low belief in the respective treatment modality. The     investigators then apply a pharmacological placebo and study the interaction between the     prevailing attitude (implicit and explicit) and the placebo effect with respect to pain     perception but also to neurobiological mechanisms using functional magnetic resonance     imaging. In addition to expectancy, conditioning of placebo will be examined and the     long-term effects of the intervention will be determined.   "
86228|NCT02157376|"     The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously     demonstrated prevention of bleeding events) during treatment period in proportion of patients     for the prevention of upper GI bleeding.   "
86229|NCT02157363|"     Open thoracoabdominal esophagectomy (TAE) is the standard curative treatment modality for     resectable esophageal cancer. TAE can be achieved by positioning the patient in the supine     position for the abdominal part and in a left-lateral decubitus (LLD) position for the     thoracic part, or by performing both parts in a left-screwed supine position (LSS). Aim of     the present study is to compare peri- and postoperative outcome variables after TAE for     esophageal cancer in the two positions.      POETRI is designed as a single-center, randomized controlled trial with two parallel arms     including patients with resectable esophageal cancer and type I cancers of the     esophagogastric junction (AEG I). Exclusion criteria are inability to tolerate surgery or     both types of positioning, inability to perform an intrathoracic anastomosis, non-malignant     pathologies. The primary endpoint is operating time. Secondary endpoints are morbidity, lymph     node yield, pulmonary function, pain control and wound healing assessed during a follow-up of     3 months.      POETRI is a single-center, randomized controlled trial to evaluate different positioning and     thoracic access during radical open thoracoabdominal esophagectomy for patients with     resectable esophageal cancer.   "
86257|NCT02156999|"     To examine the changes of bone mineral density and bone turnover markers after Bonviva     treatment in osteoporotic patients   "
87449|NCT02141425|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     single ascending doses of ASP015K.   "
86231|NCT02157337|"     Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.     Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and     postoperative mortality. Aortic surgery is the most risky surgery that causes the     postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.      Statin is a 3-hydroxy-3-methyl-glutaryl co-enzyme A (HMG CoA) reductase inhibitors and is     used primarily to lower the level of plasma cholesterol. Apart from the antilipid effect,     statin has pleiotropic effects include anti-inflammation, decrease of oxidative stress,     recovery of endothelial cell injury and stabilization of thrombus.      The pathology of AKI after aortic surgery include not only hypoperfusion of renal blood flow     but also thromboembolism, inflammatory reaction after use of cardiopulmonary bypass(CPB) and     oxidative stress. Therefore, the incidence of AKI after aortic surgery can be expected to     decrease after the perioperative use of statin because of the pleiotropic effects of it. The     aim of this study is to examine the association between preoperative statin treatment and the     incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery   "
86232|NCT02157324|"     This study is evaluating the safety and efficacy of the combined use of acalabrutinib and     ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)   "
86233|NCT02157311|"     Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment     followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for     at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to     maintain a therapeutic success defined by the absence of virological failure (2 consecutive     viral loads > 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption     or change of the  4 days on / 3 days off  strategy for a time longer than 30 consecutive     days).   "
86234|NCT02157298|"     Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with     inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and < 11% will be     enrolled into the wash-out phase or directly into the lead-in phase depending on whether the     patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1     agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as     part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl     Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be     randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the     dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects     who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open     extension treatment period.   "
86235|NCT02157285|"     This is a prospective, randomized-controlled trial in which subjects will be randomized to     receive either routine contraceptive counseling or peer mentoring plus routine contraceptive     counseling.   "
86269|NCT02156843|"     The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID     in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.   "
86270|NCT02156830|"     The project consists of qualitative interviews with all the members of the obesity team     (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish     hospitals. These interviews have the aim to gain insight into the current practice about     counseling patients with bariatric surgery, with a focus on medication counseling. This will     make it possible to assess the strengths and weaknesses in the current practice of obese     patients who will undergo and have undergone bariatric surgery.   "
86236|NCT02157272|"     Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of     Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR     2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute     thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleedings,     and death in triple aPL-positive APS patients.      Study Design A multicentre, interventional, prospective, parallel, randomised, controlled,     open-label, Rivaroxaban 20 mg qd (or 15mg qd in patients with moderate renal insufficiency)     vs warfarin (INR target 2.5), non-inferiority study, in 535 triple aPL-positive APS patients     in approximately 40 Internal Medicine and Thrombosis centres. Each local Institutional Review     Board will approve the study.      Study Population Patients of both sexes, of age 18-75, affected by anti-phospholipid     syndrome, with a high probability of recurrences as defined by triple aPL-positivity, are     eligible for this study.      Primary Outcome variables The primary cumulative outcome measure will be incident acute     thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or     death.      Secondary Outcome variables Separate evaluation of arterial and venous thrombosis and     all-cause death.      04.27.2015: An amendment has been made. Enrollment permitted till 75 years of age.   "
86237|NCT02157259|"     This is an observational study to identify the etiology, management, and outcome of     community-acquired sepsis and severe sepsis in children and adults in Southeast Asia. The     study will take place in Thailand, Vietnam, and Indonesia, the partner countries of SEAICRN.     Potential study patients will be any patients (both children and adults) who are presented at     the hospital with community-acquired sepsis or severe sepsis and require hospitalization.   "
86258|NCT02156986|"     The main objective of the study is to conduct a pilot study on the characterization of the     mastication abilities of infants and toddlers using different commercial cereal based     products in order to gain knowledge and be able to plan future studies.   "
86276|NCT02156752|"     This project is a randomized controlled trial to compare the efficacy of two interventions-     one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)-     and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All     participants will first participate in an initial 4-month standard behavioral weight loss     program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop;     the ACT workshop will teach ACT skills including acceptance and mindfulness techniques     designed to promote behavior change and health behavior persistence consistent with one's     core values. The SR program will focus on self-regulation, regular weighing, and modeling     behavior on successful maintainers. The WLO group will receive a control workshop focused on     cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24     months. The secondary outcome is change in psychological flexibility, a critical component of     ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24     months, the ACT group will show significantly greater weight loss as compared to the SR and     WLO groups.   "
86238|NCT02157246|"     A low level of oxygen in cancer cells makes them less likely to respond to chemotherapy and     radiotherapy treatments. There is interest in using new drugs that improve the level of     oxygen in tumours. Another approach would be to increase the radiotherapy dose to tumours     with low oxygen levels.      Before we can do this for patients with rectal cancer, we need to develop a reliable way of     identifying areas of low oxygen within the rectal tumour. This will make us able to tell     which patients may be suitable for such a change in their treatment.      Traditionally, the level of oxygen in tumours is measured by inserting a needle into the     tumour and measuring it directly. This is not possible in rectal cancer. This study has been     designed to identify the best alternative method. We would like to do a blood test, take     samples of cancer tissue and some detailed scans (18F-fluoromisonidazole (F-MISO) positron     emission tomography, perfusion computed tomography, functional magnetic resonance imaging).     The results of these tests will be compared to decide which gives us the most comprehensive     and reliable information.      Patients in Group A go straight to surgery. By looking for markers of low oxygen levels on     the tumour that has been removed, we will be able to find out which of the study tests     performed before the tumour was removed is the best. By repeating the scans we will be able     to see how reliable they are and how much they change on a day to day basis. We think that     tumours that still have low levels of oxygen after 8 to 10 doses of radiotherapy are the     least likely to respond to treatment.      Group B will have scans before radiotherapy treatment and after 8 to 10 doses of radiotherapy     to see if we can identify the patients that have persistent low levels of oxygen.   "
86239|NCT02157233|"     The potential of physical activity and other non-medicinal methods for the care and     prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a     potential influence of environmental heat in energetic balance regulation. However, the     existing knowledge is insufficient to optimize physical activity programs based on the impact     of exercise on energy intake regulation in hot climates. The aim of the present study is to     define the major physiological determinants of short-term food intake regulation in young     active and healthy men, when exposed to different levels of metabolic activity and     environmental temperatures. We will thus explore the biological mechanisms related to     post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will     be analysed in these different environmental conditions, with a special focus on the effect     of the birth weight. This study should open interesting ways to define adequate nutritional     and exercising programs in hot environments.   "
86240|NCT02157220|"     This is a randomised control trial comparing two different prosthetic designs used in total     knee arthroplasty. Participants were randomised to receive either of the two prostheses and     then were followed up of a period of 7 years, looking at pain, range of motion and impact on     quality of life. The literature and joint registry of Australia shows that one of the     prosthesis may be inferior to the other. Our research team hypothesised that this was not the     case and that previous elicited differences were related to other factors.   "
86241|NCT02157207|"     This research is,being done to better understand how antioxidants (vitamins C, E and Alpha     Lipoic Acid) af,f,ect the heart,and arteries. For this study, we will obtain blood samples to     measure oxidative stress markers (substances in the blood that are linked to oxidative     stress), cholesterol, insulin and blood glucose (sugar), as well as measure how well the     heart and arteries are working following supplementation with the antioxidants.      Our central hypothesis is that acute antioxidant supplementation will improve arterial     function at rest and during exercise in African Americans without an impact of age, whereas     aging will modify these effects in Caucasians.   "
86242|NCT02157194|"     EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular     analysis. The purpose of this study is to evaluate if samples from on lymph node site can be     divided for diagnosis and molecular analysis.   "
86243|NCT02157181|"     The study will test the effectiveness (rate of complete remissions, total remission rate and     duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous     cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for     relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous     therapy.      CD20* = cluster of differentiation antigen 20   "
86244|NCT02157168|"     The investigators propose to test a community-developed and targeted intervention that     employs community health workers (CHWs) as aides to newly Medicaid-insured women. These women     face the challenges of engaging with their healthcare and health and of making highly     personal and socioculturally embedded decisions about reproductive health-related preventive     services (e.g., contraception, STI and cancer screening).   "
86245|NCT02157155|"     Hypothesis        1. To define whether stimulation of ATGL and suppression of G0/G1 switch gene occur in the          initial phases of diabetic ketoacidosis and thus can be identified as the primary          mechanisms behind this life threatening condition.        2. Make a human model for studying ketoacidosis.      The investigators plan to reduce in their regular insulin over night. In the morning we     administer endotoxin, which together with a relative lack of insulin will initiate     ketogenesis - a state of ketoacidosis. On another occasion strict glycemic control is imposed     by means of intravenous insulin. The testing is done two separate days with at least 3 weeks     in between and patients are admitted to hospital the evening before the day of testing. The     investigators use isotopic tracers to determine metabolic fluxes and analyse fat (ATGL, G0/G1     switch gene) and muscle biopsies.   "
86246|NCT02157142|"     The purpose of this study is to evaluate the safety and performance of the HLT System in     patients with severe aortic stenosis who present at High Risk for aortic valve replacement     surgery.   "
86274|NCT02156778|"     Patients after ischemic stroke are at high risk of recurrent cardiovascular events and of     developing post-stroke complications. There is a substantial gap between risk factor     management in real life and that recommended by international guidelines. Stroke Card is a     multifaceted comprehensive post-stroke disease management program to detect and treat     complications and optimize secondary prevention. The investigators hypothesis that, compared     to standard care, Stroke Card will lead to an at least 13.3% risk reduction in recurrent     cardiovascular events and improve health-related quality-of-life.   "
92181|NCT02079493|"     The purpose of this study is to obtain patient-oriented and clinically-oriented physical     function outcomes both pre-operatively and post-operatively in patients receiving a total     knee arthroplasty .   "
86247|NCT02157129|"     Patients after tracheostomy represent a substantial part in the ear nose throat clinic.     Long-term intubated patients in intensive care units also profit from tracheostomy due to an     improved respiratory toilet. However, after tracheostomy patients demonstrate shunt     ventilation bypassing the sinonasal and pharyngeal system. The physiological moistening,     cleaning and warming of the breathing air fail resulting in a respiratory inflammation.     Beside a variety of supportive medical devices no general recommendation exists at present.     Recently, we demonstrated the beneficial application of local phospholipids in Sjoegren's     syndrome and antineutrophil cytoplasmatic antibody associated sinonasal vasculitis.      In the current monocentric, two-armed, double-blinded, randomized parallel group study we     would like to evaluate the beneficial application of LipoAerosol© when compared with standard     physiologic saline inhalation. LipoAerosol© is a licensed, tradable medical device and will     be applied as part of its intended use. Liposomal inhalation solution provides moistening,     cleaning and warming of the upper and lower respiratory tract and supports the natural     moistening film in airway irritations and diseases.      Blood parameter (leucocytes and c reactive protein) and tracheobronchial secretion     (Lymphocyte subpopulation, c reactive protein, lactate dehydrogenase, granulocyte macrophage     colony stimulating factor, interferon γ, interleukins 10, 12 (p70), 13, 1β, 2, 4, 5, 6, 7, 8,     tumor necrosis factor α) will be collected 1, 3, and 10 days after tracheostomy. In addition,     medical examination records the number of suction maneuver (0 points: none; 1 point: 5-10x/d;     2 points: 10-20x/d; 3 points: >20x/d), flexible-optical assessment of tracheo-bronchial     redness (0 point: none; 1 point: peristomal; 2 points: tracheal; 3 points: tracheo-bronchial)     and flexible-optical assessment of mucous congestion (0 point: none; 1 point: fluent; 2     points: tenacious; 3 points: barky).      Subjective estimation of the respiratory impairment will be analyzed via visual analogue     scale (Subjective overall impairment, coughing frequency, breathlessness, mucous congestion,     color of sputum, consistency of sputum). The study is designed without any additional     invasive or incriminating clinical examination.      Aim of the study is to maintain the functional integrity of the tracheo-bronchial system     after tracheostomy using LipoAerosol© resulting in a general therapeutic recommendation.   "
86248|NCT02157116|"     Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less     time between treatments than in standard chemotherapy. The two chemotherapy drugs used in     this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given     every 21 days. This study is exploring the response to chemotherapy when these drugs are     given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens     to identify signatures that may predict chemotherapy sensitivity or resistance.   "
86249|NCT02157103|"     STUDY BACKGROUND:      This research will involve patients with glioblastoma. The drug bevacizumab (Avastin) is FDA     approved for the treatment of glioblastoma that gets worse after standard therapy. For     glioblastoma, bevacizumab is given by vein every 14 days. The purpose of this study is to see     if bevacizumab works as well when it is given as a daily subcutaneous shot as it does when     given intravenously. A subcutaneous shot is like an insulin shot or a heparin shot. The dose     of bevacizumab given on this study is in total slightly lower than the FDA approved dose for     glioblastoma.      STUDY DESCRIPTION:      About 10 people will take part in the study. Participants or caregivers will be educated on     injection and given prefilled syringes to take home. Participants or caregivers will     administer bevacizumab subcutaneously each day. The bevacizumab will be stored in the     refrigerator.      Follow up visits will be weekly for the first 3 weeks, then every 3 weeks. After 18 weeks,     the follow up interval can be increased to every 6 weeks at the treating physician's     discretion.      Participants can keep taking the bevacizumab until:        -  Tests show that they are not benefiting from it,        -  The participant has a bad side effect related to study treatment,        -  The participant can no longer comply with study requirements, or        -  The participant or doctor feels it is no longer in the participant's best interest.   "
86250|NCT02157090|"     Recent clinical studies showed, that a hydrocolloid patch is effective, well tolerated and     comparable with aciclovir cream 5 % for the treatment of HSL lesions, while affording     additional benefits of wound protection, discretion and relief of social embarrassment. The     aim of the actual study was the clinical assessment of the effectiveness and safety of     Hansaplast® SOS Herpes Patch (HPHP) in comparison to Compeed® Herpes Vesicle Patch (CHP) in     treating HSL. Both products are CE-certificated and are available at the market for medical     devices.   "
86251|NCT02157077|"     The purpose of the current study is to evaluate the ability of Eylea to induce a regression     of PED height on patients previously extensively treated by Lucentis.      The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval     injection until week 26.   "
86253|NCT02157051|"     This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic     acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor     receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based vaccine     may target immunogenic proteins expressed in breast cancer stem cells which are the component     of breast cancer that is resistant to chemotherapy and has the ability to spread. Vaccines     made from DNA may help the body build an effective immune response to kill tumor cells.   "
86254|NCT02157038|"     This study is investigating whether changes in the shape and size of bodily muscles and     spinal cord anatomy can influence recovery rates following a motor vehicle collision (MVC).     The objective is to demonstrate that the presence of muscle and spinal cord degeneration and     associated muscle weakness is the consequence of a mild MVC-related injury involving the     cervical spinal cord.   "
86255|NCT02157025|"     The majority of young children do not think that visual field (VF) testing of peripheral     vision is similar to a game; therefore, it is not surprising that they have difficulty     maintaining attention during VF testing and thus the test reliability suffers as a     consequence. Poor VF reliability has been a longstanding, major issue since it leads to an     increased number of tests and/or longer duration of time needed to determine when there are     true vision losses. Providers are less likely to obtain VF tests in children since the     results are of doubtful value and challenging to interpret when they are inconsistent.     Effectively this means that children with untreated, slowly progressive eye diseases may go     undiagnosed and incur greater visual losses. The investigators aim to create a prototype     device that the investigators hypothesize will make VF testing more engaging for young     children, thus increasing their attention and consistency of their responses to the test     stimuli, which in turn should improve VF reliability. The components include a microdisplay     video screen (1.5 diameter) as the fixation target (instead of the standard LED light)     displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon     character voices presented by the test operator to provide instructional feedback based on     the child's performance during testing. Improved VF reliability from the investigators     intervention would translate to improved diagnosis and care for young childrens' peripheral     vision loss through widespread implementation of the investigators innovative, affordable and     readily adoptable system at eye care providers' offices.   "
86256|NCT02157012|"     To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis     patients   "
86259|NCT02156973|"     Coming for a cardiac test can be a daunting experience. Despite providing written information     sheets for patients, experience in the scanner demonstrates that many patients are     ill-prepared when they attend for cardiac computed tomography (CT). Heart rate control is     essential for high image quality, as this prolongs cardiac diastole (during which imaging     occurs) and results in less motion blur, but this may be challenging to achieve in the     context of an anxious patient. In such situations, additional radiation exposure is required     to optimise the chances of diagnostic images. Thus, poor patient selection and preparation     has been shown to increase the radiation burden to the patient, as well as to increase the     rate of non-diagnostic scans, leading to patients needing additional, alternative testing.     This can be distressing for patients and increases downstream costs for the hospital. Poor     patient awareness is also known to increase the anxiety of attending for a test.      Improved patient information and understanding has been shown to improve outcomes in a wide     variety of hospital settings. Evidence from cardiac catheterisation angiography suggests that     the use of alternative information formats can reduce patient anxiety and improve patient     satisfaction, as well as improving their understanding of the technical requirements of a     test. The latter may contribute to improved preparation - for example, patients who do not     understand the requirements for cardiac CT, particularly the need for a slow heart rate, will     often consume caffeine, stop their heart-slowing drugs, or even run or cycle to their     appointment.      We have agreed a collaboration with Plymouth University to create patient information videos     for CT. These will utilise the expertise of media students (their department also runs a     commercial arm, due to the quality of their output), in conjunction with the clinical     requirements and patient participation groups, to create an accessible, engaging and     informative film. We wish to evaluate the impact of this method of conveying information to     patients on how well they are prepared to undergo testing.      If this concept is successful, it may be of use to patients undergoing a huge range of tests     or treatments across specialities. We therefore need to demonstrate the efficacy (or     otherwise) of such an intervention.   "
86260|NCT02156960|"     It has not been well known about the changes of bone metabolic markers, bone mineral density     and other bone-related markers after teriparatide and/or denosumab treatment in Japanese     osteoporotic patients.   "
86261|NCT02156947|"     In theory, increased vascularity of GB wall could be associated with intraoperative findings,     such as, GB wall inflammation and accompanying adhesions. There are not enough reports in the     literature describing the correlation between GB wall vascularity and operative findings     according to adhesion scoring scale. In this prospective clinical study, we aimed to     highlight the correlation between preoperative power Doppler sonography detected GB wall     vascularity and intraoperative findings - postoperative outcomes of chronic and acute     cholecystitis patients.   "
86262|NCT02156934|"     This study was designed to provide confirmation of efficacy of muscle derived stem cells     (MDCs) for the treatment of SUI in women.   "
86263|NCT02156921|"     This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound     training compared to self-directed training with written handouts on subsequent performance     on simulated patient cases and theoretical cases.   "
86264|NCT02156908|"     The investigators will first test, in a pilot study, the effects of 3 days of D-serine (DSR)     on auditory plasticity in a sensory based remediation (SBR) paradigm, and then do a     small-scale double-blind study of DSR + SBR on auditory emotion recognition.   "
86265|NCT02156895|"     The objective of this study is to monitor the usage of INLYTA® in real practice, including     the adverse events associated with INLYTA®.   "
86266|NCT02156882|"     In this longitudinal study with a follow up time of at least 6 months, up to 300 tuberculosis     (TB) patients or TB suspects will be screened for TB using the Xpert MTB/RIF assay along with     standard smear microscopy after Ziehl-Neelsen staining at the TB health clinic located at     Mavalane health center. Confirmed TB cases will be followed up during TB therapy until month     six after treatment initiation in order to obtain clinical and microbiological data on     treatment including treatment response. Apart from relevant research questions in the field     of TB diagnostics and treatment, the main objective of this study will be the development of     a clinical TB research site, including capacity development in clinical and laboratory based     TB research methods, in Mavalane, Maputo.   "
86267|NCT02156869|"     Although the number of recommendations against systematic screening of prostate cancer, 70%     of patients still request testing because they overestimate the benefits and are unaware of     the limitations.      The investigators aim is to assess the impact of a short printed decision aid presenting     benefits and limits of screening, on patients' intent to undergo prostate cancer screening.   "
86268|NCT02156856|"     Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome,     mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or     cardiac output due to hypovolemia or cardiac defects play a central role in causing poor     peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive     and non-invasive methods available. Up to the present date it is unknown, if these methods     may by used interchangeably in patients with severe cardiac defects like aortic stenosis.   "
86271|NCT02156817|"     Moderate and late preterm infants contribute to significant neonatal intensive care unit     health care resource utilization because of their sheer numbers. Determinants of the length     of hospitalization (LOH) in this population are understudied. Gestational age (GA) is used     most commonly as a predictor for LOH but there are many limitations including inaccurate     dating and morbidities of prematurity which at least partly related to neurophysiological     immaturity. The latter can be assessed by amplitude integrated electroencephalogram (aEEG, a     simplified 5 lead EEG), and possibly by heart rate variability (HRV) and respiratory     variability (RV). All 3 are non-invasive tests that can be done at the bedside. Our study     hypothesis is to determine if neurophysiologic maturation as assessed by aEEG, HRV and RV     within 24-96 hours following birth improves the correlation between gestational age and     length of hospitalization compared to gestational age alone.   "
86272|NCT02156804|"     The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0     Grade 3 or higher), treatment-related, select adverse events in subjects with histologically     confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment     containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with     Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.   "
86273|NCT02156791|"     gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.     The purpose of this clinical trial is to confirm the safety, clinical tolerability and     immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with     grass pollen-induced allergic rhinoconjunctivitis, and to determine the maximal tolerated     dose of gpASIT+TM .   "
86275|NCT02156765|"     Three purpose of this study:        1. Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in          ischemic stroke patients;        2. Evaluation on specificity and sensitivity of STAF score;        3. Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical          database and sample database of ischemic stroke.   "
86278|NCT02156726|"     FCR (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold     standard in treatment of younger and physically fit CLL patients. These excellent results,     however, cannot be generally applied to the whole CLL population. This is because the median     age at diagnosis of CLL lies between 65 and 72 years and patients older than 65 years in fact     account up to 50%-75 % of the CLL population. Nevertheless, such population is considerably     underrepresented in most of the large clinical trials in CLL/SLL. Therefore, it is not clear     whether elderly/comorbid patients could profit from newer treatment approaches such as purine     analog combinations or chemoimmunotherapy. Several publications demonstrated unacceptable     toxicity of full-dose FC/FCR in elderly CLL patients. However, regimens using attenuated     doses of fludarabine and cyclophosphamide showed promising efficacy and low toxicity.   "
86279|NCT02156713|"     Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy     (CP). It is currently part of standard of care for children with unilateral CP, but is     typically done one-on-one and with the child wearing a cast 24 hours a day during the     duration of treatment. The purpose of this study is to assess the effects of an intensive     group-based CIMT summer camp in which participants wear a removable cast on upper extremity     function, occupational performance, and patient-specific goals. The investigators hypothesize     that upper extremity skills and occupational performance will increase, and that patients     will reach their individualized goals.   "
86280|NCT02156700|"     Shear Wave Elastography (SWE™) is a quantitative elastography method for measuring tissue     stiffness. The difference in stiffness between benign and malignant tumors has been     demonstrated by other elastography methods (acoustic radiation force impulse imaging,     transient elastography and/or magnetic resonance elastography). The investigators     hypothesized that benign liver tumors are softer than malignant liver tumors measured by     SWE™, allowing differentiation between the two by tumor stiffness expressed in kilopascal     (kPa). In this study benign and malignant liver tumors will be evaluated in five groups: 1)     hemangioma and 2) focal nodular hyperplasia (FNH) representing the most common benign liver     tumors; 3) metastases and 4) cholangiocarcinoma (CCC), both presenting malignant tumors     mostly appearing in otherwise healthy liver, and 5) hepatocellular carcinoma (HCC) mostly     occurring in cirrhotic liver, which can potentially influence elastographic measurements     therefore querying the appropriateness of comparison between tumors in healthy and cirrhotic     liver. Enrolled patients will undergo transabdominal ultrasonography and SWE™ examination.     The tumor stiffness will be measured five times for each tumor. Additionally, surrounding     liver parenchyma stiffness will be measured. The nature of the liver tumor will be defined     through a standard diagnostic workup according to current guidelines, including contrast     enhanced multi-slice CT, MRI and/or cytology/histology, as applicable. In the final analysis     the mean tumor stiffness and tumor-parenchyma ratio will be calculated for each group as well     as for benign and malignant tumors separately, and cut-off values for the differentiation of     various groups will be derived. The clinical value of the method will be appraised based on     specificity, sensitivity, positive and negative predictive values, and AUC.   "
86281|NCT02156687|"     The primary objective of the proposed study is to determine the difference in suturing time     when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of     laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.      Hypothesis: Suturing time when using the restorelle Y mesh will be faster than when using the     restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic     sacrocolpopexy.   "
86282|NCT02156674|"     This is a single center study in which Naglazyme® will be given weekly for two years in     patients with Maroteaux-Lamy syndrome, also known as mucopolysaccharide VI (MPS VI), who have     previously been treated with an allogeneic transplant.   "
86283|NCT02156661|"     The purpose of this study is to determine whether oxytocin influences emotional processing     and learning of emotional and social stimuli.   "
86284|NCT02156648|"     The purpose of this project is to assess the feasibility of collecting plasma samples for     cardiac biomarker assessment, and to identify if there is an associations between the     biomarkers, echocardiographic features and the cardiac PET scan results (in patients     receiving radiation therapy). This is the first step in a research program that has an     overall goal of being able to predict early-treatment induced cardiotoxicity in patients with     breast cancer.   "
86285|NCT02156635|"     The purpose of this study is to determine whether active stimulation of the affected     hemisphere will be more effective than simulated current in treatment of stroke   "
86286|NCT02156622|"     The purpose of this study is to adapt depression treatment intervention for HIV patients in     Cameroon. The PI will validate a depression severity measure, adapt key elements of the     intervention to the Cameroon context, train nurses and physicians to carry out the     intervention, and examine preliminary outcomes.      Participants: Aim 1: Hospital and clinic patients, visitors, health care workers. Aim 2: No     participants. Aim 3: HIV-infected patients. Procedures (methods): Survey instruments and ARV     treatment.   "
86287|NCT02156609|"     The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory     support. The study will assess the safety and performance of the HeartMate PHP in supporting     patients who are hemodynamically unstable, or at risk of being hemodynamically unstable,     while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.   "
86288|NCT02156596|"     The aim of the investigators study was to evaluate the feasibility, efficacy and safety of     nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the     management of renal colic.      Determine the need for systematic outpatient prescription of NSAI.   "
86289|NCT02156583|"     This is an observational study evaluating changes in frailty and associated impairments in     older heart failure patients receiving left ventricular assist device therapy.   "
86290|NCT02156570|"     The purpose of the study is to examine whether patients who have acute or early chronic     hepatitis C virus (HCV) infection can be treated effectively and safely with an     interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with     one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study     will investigate whether treatment of acute or early chronic HCV can be shortened. The study     will assess efficacy by looking at the proportion of people who clear the virus (have no     virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after     treatment.      The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will     result in successful virological eradication in the majority (≥80%) of subjects treated for     recently acquired HCV.   "
86364|NCT02155608|"     The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a     potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).      Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment     on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles,     other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect     profiles.   "
86291|NCT02156557|"     We are studying new ways to look for abnormal areas/tissues of the colon during a     colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't     look different to the naked eye, then the scope can't improve on that. We are using special     stains or dyes and special scopes to see abnormal areas that are hard to see with the naked     eye. The stain or dye is fluorescent, meaning it glows when special light is used in the     colonoscopy scope.      You are being asked to let us spray a peptide with a fluorescent tag onto your colon.     Peptides are small chains of amino acids (the building blocks that make up proteins) linked     together. The peptide we use has 7 amino acids attached to a fluorescent tag (FIT C or     Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye     drops).      We are testing this fluorescent peptide to see if it will stick if there are any abnormal     areas. If the peptide sticks, it will glow when a special light in the scope is used. In     this study, we will apply the fluorescent peptide to your colon by using a spray tube that     fits in the colonoscope.      This is a phase IB study. This means that although we have applied the peptide to 25 people     in our first research study, we still need to learn more about fluorescent peptide in     people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing     us to test it in this study. The main goal of this study is to see if the peptide glows     well and if we can take pictures of areas that do glow.      This is a research study of the peptide and our ability to see it glow or fluoresce. Being     in this study and applying the peptide won't change how our biopsies are taken or how your     colonoscopy is done.   "
86292|NCT02156544|"     The purpose of this study is to investigate the safety/tolerability and     pharmacokinetics/pharmacodynamics of CKD-519.   "
86293|NCT02156531|"     Research in the last fifteen years suggests that anxious individuals selectively attend     towards threatening information. Attention modification interventions for internalizing     adults have been developed to target cognition at this basic level; these programs have     demonstrated initial efficacy in attention bias and anxiety symptom reduction. To date, there     have been minimal published studies of attention modification in youths with clinical levels     of anxiety.      This study is a large randomized efficacy-effectiveness trial (N = 498) to test the benefit     of this low-cost, computerized attention modification intervention (Cognitive Bias     Modification (CBM) computer application) for anxiety disorders and symptomatology in youth     ages 12 to 17. This trial conducted will compare three intervention arms, all of which     include underlying treatment as usual (TAU). The investigators directly test the level of     clinical support (scaffolding) needed to adequately deliver self-administered CBM to     anxious youth, a finding that will be key to preparing for future deployment-focused trials.     The investigators will compare an attention control version of the CBM program (Arm 1) to two     active versions of the CBM intervention that have varying levels of patient clinical support:     a self-administered CBM program that participants download and install on their home     computers (Self-Administered CBM-only; Arm 2), and the same CBM program paired with an     adherence promotion (AP) component delivered via brief telephone calls from study coaches,     including as needed, brief motivational enhancement and/or technical assistance     (Self-Administered CBM+AP; Arm 3).      The investigators expect that youth receiving CBM and CBM+AP will have improvement in anxiety     symptoms and functioning. The investigators will also complete a cost-effectiveness analysis     to examine potential costs offset by this intervention.   "
86294|NCT02156518|"     The purpose of this study is to determine if the systematic practice of Vocal Function     Exercises (VFE) improves selected measures of voice production in participants who have     previously been irradiated for early glottic cancers compared to participants who receive the     present standard of care, namely, vocal hygiene counseling. It is hypothesized that a     prescriptive vocal exercise program (VFE) will improve the voice production of individuals     who have been previously treated for laryngeal cancers when compared to participants who     receive vocal hygiene alone.   "
86295|NCT02156505|"     Self-expandable metallic stents provide effective palliation of malignant gastric outlet     obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor     in-growth through the stent mesh. The Self-expandable metallic stents which has the design of     smaller wire mesh size (double bare stent) were developed and used in Korea. This new design     was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The     end point of this study is the 8-weeks patency rate after placement of double bare as well as     technical and clinical success rates.   "
86296|NCT02156492|"     The main purpose of this study is to investigate how the body responds to evacetrapib and to     evaluate the safety and the effect of evacetrapib, alone and in combination with selected     statins, in healthy Chinese participants. The study has 2 parts. Part one will last up to 4     weeks and part two will last up to 5 weeks, not including screening. Participants may only     enroll in one part.   "
86297|NCT02156479|"     This study in a cohort of allo-HSCT recipients aims to validate the suitability of an     improved T-Track® CMV assay to assess the functionality of CMV protein-reactive effector     cells and its suitability to determine cut-off values mediating protection from recurrent CMV     reactivations in allo-HSCT recipients.      Lophius T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess     the functionality of a network of clinically relevant CMV-reactive effector cells. It is     based on the stimulation of peripheral blood mononuclear cells (PBMC) with activated     immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific     CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.   "
86298|NCT02156466|"     This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in     subjects with moderate to severe psoriasis to assess the safety, tolerability,     immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple     subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F [Anti-IL-17A/F] Nanobody).   "
86299|NCT02156453|"     Total knee replacement is one of the most successful surgical procedures in Orthopaedics.     However, 10-20% of the patients are still dissatisfied with the results of the surgery. In     general, the evaluation of postoperative functional outcomes are usually measured by     self-report questionnaires, such as the Western Ontario and Mcmaster Universities     osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to     evaluate functional outcome of the patients is to use the performance-based tests such as the     two-minute walk test, but there is still little information regarding its use for evaluating     functional recovery in patients receiving total knee arthroplasty.      The objectives this study are: 1) to assess the relationship between self-report     questionnaires and performance-based tests among patients scheduling for TKA; and 2) to     identify clinical variables that are associated with pre- and postoperative functional     performance of the patients.   "
86402|NCT02155114|"     The purpose of this study is to survey iron storage levels and their prognostic consequences     in the context of acute inflammation. The impact of iron substitution in inflammatory states     is controversial. We hypothesize that iron substitution may influence outcome in patients in     inflammatory states.   "
86300|NCT02156440|"     Osteoarthritis (OA) affects approximately 10% of people older than 60 years, and compromises     the quality of life of more than 21 million North Americans. Studies on the use of     complimentary and alternative medicines have reported that OA patients in the US are among     the highest users of CAM. Previous studies on a unique natural mineral product SierraSil®     demonstrated an improvement in joint health and function in subjects with mild to moderate OA     of the knee. Extracts of Sierrasil® are reported to reduce cartilage degradation in response     to IL-8 and nitric oxide production suggesting an ability to suppress IL-8 mediated events in     human cartilage. The primary objective is to assess the efficacy of SeirraSil Joint Formula     versus placebo on the symptoms of osteoarthritis as assessed by WOMAC™ Osteoarthritis Index     Pain subscale in subjects with osteoarthritis of the knee.   "
86301|NCT02156427|"     The purpose of this study is to assess the efficacy of autologous epidermal cells suspension     grafting using a newly developed device named VITICELL® compared to placebo.      The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient     and investigator.   "
86302|NCT02156414|"     Prostate cancer is considered the fourth most common malignancy cancer in America. However,     in Colombia the incidence is higher, and it is considered the second cause of death among men     for malignance diseases. In the framework of clinical localized prostate cancer there is a     controversy regarding the best predictors of risk and the best treatment options. The actual     literature is discussing the possibility of underestimate the disease and actual tools are     not sufficient for proper characterization. Is in this context that extended pelvic     lymphadenectomy emerges as a stratification tool in prostate cancer that defines the real     commitment of the disease. The investigators need to know the characteristics that the     disease has on the investigators community so the investigators can generate appropriate     therapeutic approach. Thus, the present prospective observational-descriptive multicenter     study, want to determine in three referral centers in Bogotá Colombia , the frequency of     pelvic node involvement in patients with localized clinical prostate cancer from the     stratification achieved by pelvic lymphadenectomy extended.   "
86342|NCT02155894|"     The study aims to investigate the effect a systematic telemedicine intervention, based on the     tigth control principals, as a platform for disease monitoring among patients with rheumatoid     arthritis.      It is hypothesized that:        -  A systematic telemedicine intervention targeted to tight control of disease activity          among patients with RA will be equally effective as usual care (outpatient consultation          by a rheumatologist).        -  There will be no difference in the effect whether this telemedicine consultation is          carried out by a rheumatologist or a rheumatology nurse.        -  Patient satisfaction and the patient's general perception of involvement in their          treatment will be increased for patients who receive the telemedicine intervention.        -  All the effects will apply both in the short term (< 6 months) and in the long term (> 1          year).   "
86343|NCT02155881|"     The purpose of this study is to explore the efficacy and safety of Ciclesonide Nasal Spray     200 microgram (mcg) once daily in the treatment of seasonal allergic rhinitis (SAR) in     Russian participants.   "
86303|NCT02156401|"     Venous thromboembolism (VTE) with its two clinical manifestations deep vein thrombosis (DVT)     and pulmonary embolism (PE) is a life-threatening disease that is associated with     considerable morbidity and mortality. The incidence of VTE increases with age and it - as the     third most common cardiovascular disease after ischemic heart disease and stroke - represents     an important public health problem in industrialized countries with several aspects in need     to be addressed.      VTEval Project includes three long-term prospective observational studies to evaluate and     improve VTE diagnostics and management, treatment and outcome. The aims of the project     include a systematic assessment of VTE, i.e. disease status (symptoms, clinical and     subclinical aspects) and risk profiles (classic, psychosocial and environmental factors),     using a system-oriented approach. VTEval collects three large prospective cohorts of patients     with suspected and incident VTE consisting of individuals with a clinical suspicion of acute     PE, individuals with a clinical suspicion of acute DVT, and individuals with incidental     diagnosis of VTE).      The standardized and harmonized data acquisition of the study establishes a sustainable     resource for comprehensive research on VTE, thus providing the basis for both short- and     long-term analysis.   "
86304|NCT02156388|"     This study is designed to access the safety, tolerance and     Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in     patients with metastatic tumors.   "
86305|NCT02156375|"     The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels)     comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL)     liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6     milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.   "
86306|NCT02156362|"     It is generally estimated that 5 % of patients with thyroid cancer will develop distant     metastases, and most of them had an advanced stage of the disease at presentation. Thirty per     cent of them are resistant to radio iodine therapy and are called refractory. Their long     term survival is estimated to be less than 10 %.      The objective of this study is to identify the factors associated with poor outcome in a     cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and     medullary thyroid carcinomas were excluded.   "
86307|NCT02156349|"     This study is a German, prospective, multicenter, controlled, cluster-randomized,     interventional comparative study evaluating the efficacy and benefits of integrated PDM care     by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into     two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.   "
86308|NCT02156336|"     The purpose of this trial is to determine if patients suffering from diabetic peripheral     neuropathic pain treated with ranolazine will have a greater reduction in pain compared to     placebo.      Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical     animal model of neuropathic pain, the investigators hypothesize that subjects randomized to     ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.   "
86309|NCT02156323|"     This single center, open-label, randomized study will investigate the drug-drug interaction     potential between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate     sodium (CMS).   "
86310|NCT02156310|"     Background: High blood pressure is a common complication observed in cancer patients     prescribed anti-VEGF drugs. Increased blood pressure increases the risk of heart attacks and     strokes, thus adversely affecting survival and quality of life in this patient group.     However, little is known about the mechanisms leading to high blood pressure with anti-VEGF     drugs. As a result, the management of anti-VEGF drug-induced hypertension is largely     empirical. A better knowledge of effects of specific blood pressure lowering drugs, i.e.     antihypertensives, on anti-VEGF drug-induced hypertension would optimize therapeutic     management and reduce the risk associated with hypertension and proteinuria in patients with     cancer.      Methods: Datasets of two completed GSK clinical trials using the anti-VEGF drug pazopanib,     i.e. VEG108844 and VEG105192, will be accessed to 1) determine the way blood pressure changes     over time after commencing anti-VEGF treatment; 2) identify whether there are any     relationships between pre-study and baseline blood pressure values, treatment with specific     antihypertensive drugs, and changes in blood pressure after commencing anti-VEGF treatment;     and 3) identify whether specific antihypertensive drugs and drug combinations, prescribed     either before or after commencing anti-VEGF treatment, lead to a better blood pressure     control and prevent proteinuria during anti-VEGF treatment. Specific statistical analyses     will be conducted to assess and identify associations and will account for other patient's     characteristics and repeated observations over time. The investigators plan to conduct this     study over 6 months.      Studies VEG108844 and VEG105192 have been selected as they investigate the same anti-VEGF     drug, pazopanib, in a homogeneous group, i.e. patients with renal cancer. At the same time,     inclusion of a placebo arm as well as a treatment arm with a different anti-VEGF drug,     sunitimib, will allow initial comparisons across different groups.      The results deriving from this study will provide important knowledge on 1) patterns of blood     pressure changes with anti-VEGF drugs and 2) whether specific antihypertensive drugs or drug     classes might be better than others in preventing and managing anti-VEGF induced hypertension     and proteinuria.   "
86311|NCT02156297|"     It is a prospective, non-interventional, open-label study, in order to observe the safety and     response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction,     consolidation, salvage, maintenance or alleviative treatment. The duration of the study from     June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The     inclusion criteria is:        1. Definitely diagnosed as AML        2. FLT3-ITD mutation has been confirmed        3. Accepting the prescription of sorafenib   "
86312|NCT02156284|"     The objective was to compare the frequency and intensity of symptoms of fear in patients of     preoperative cardiac surgery who received empathic behaviour from nurse or those who received     no specific type of empathic behaviour. This is a randomized clinical trial. The sample     consisted of 44 patients in preoperative of cardiac surgery, who were divided in two groups:     empathic behaviour by nurses and without specific empathic behaviour. Fear was assessed at     two time points: before and after the intervention. The instrument used was developed and     validated, comprising 15 defining characteristics of the nursing diagnosis fear. The     hypothesis is that the group who received empathic behaviour from nurse will reduce the     anxiety.   "
86313|NCT02156271|"     The purpose of this study is to help scientist better understand the effect of a 12-week     single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U.     S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep     or staying asleep). The study will measure levels of inflammation, fasting insulin and     fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.   "
86314|NCT02156258|"     This is a case collection study of breast images using standard and new mammography     technology.   "
86372|NCT02155504|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)     of single ascending oral doses of ASP3700 in healthy male subjects. This study will also     explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to     evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in     healthy male subjects.   "
86315|NCT02156245|"     The aim of this study is to assess the efficacy of a rehabilitation protocol based on     individualized combined eccentric and concentric cycle ergometer training compared to     classical concentric cycle training among patients with either coronary artery disease (CAD)     or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the     efficacy of combined eccentric/concentric training on physical capacity and overall autonomy,     and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and     muscular effort and tolerance.      The research will take place in 3 phases:      PHASE 1 (DURATION 6 MONTHS):      30 healthy volunteers will be included to test tolerance to personalized exercise on an     eccentric cycle ergometer.      PHASE 2 (DURATION 6 MONTHS):      15 patients suffering from coronary artery disease (CAD) and 15 patients suffering from     chronic obstructive pulmonary disease (COPD) will be included to test the same protocol.      PHASE 3 (DURATION 24 MONTHS):      A total of 169 patients split into 2 parallel groups will be included: a group receiving     conventional rehabilitation (group A) and the other group receiving eccentric exercise     combined to conventional rehabilitation (group B).      Coronary patients: 93 patients will be included (62 patients in group A and 31 in group B).      COPD patients: 76 patients will be included (38 patients per group).   "
86316|NCT02156232|"     The purpose of this study is to determine whether transjugular intrahepatic portosystemic     shunt (TIPS) combined with large spontaneous portosystemic shunts embolization are effective     in the prevention of refractory hepatic encephalopathy (HE).   "
86317|NCT02156219|"     The purpose of this study is to determine whether the separation of men and women in the     metro of Mexico City leads to an improvement in the violence and perception of violence     towards women.   "
86318|NCT02156206|"     The purpose of this study is to determine whether the 123 women emergency phone line of     Medellin (Colombia) leads to a reduction in the violence suffered by women, as well as in     their psychological wellbeing and attitudes towards violence.   "
86319|NCT02156193|"     Although endoscopic colonic polypectomy has been an established procedure for two decades,     the risk of bleeding is still higher after resecting of pedunculated polyps, because of the     presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine     injection have been proposed in the management of postpolypectomy bleeding in large colonic     polyps. For prophylactic clip, there was no randomized controlled study assessing the     efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So     the investigators designed a randomized controlled trial to confirm the efficacy of     application of prophylactic clip in the prevention of postpolypectomy bleeding in large     polyps.   "
86320|NCT02156180|"     In this study the Investigators aim to determine specific volatile compounds present in     breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before     and after tumour resection or before and after chemotherapy +/- radiotherapy using gas     chromotography-mass spectrometry. The Investigators hypothesize that study participants with     a tumour will display a distinct set of volatile organic compounds than can serve as     potential cancer biomarkers.   "
92182|NCT02079480|"     The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK)     and pharmacodynamics (PD) of BMS-986090 in healthy subjects.   "
86321|NCT02156167|"     The purpose of this study is to evaluate the effect of the sound processor upgrade from the     C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor     for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability     of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810     Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance     criteria of the postoperative Codacs™ system test and to evaluate the usability of the     Codacs™ Test System.   "
86322|NCT02156154|"     Some patients have respiratory depression (decreased breaths per minute) after surgery.     Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this     study is to determine if acetaminophen decreases respiratory depression after surgery. The     investigators will also evaluate the cost effectiveness of acetaminophen.      Patients having elective major abdominal surgery are being asked to participate in this     research study. If eligible, a patient will have their baseline tidal volume (amount of air     moved into or out of the lungs) and vital capacity (how much air the lungs are capable of     holding) measured using a spirometer (apparatus for measuring the volume of air inspired and     expired by the lungs) measured before surgery. Three questionnaires will also need to be     completed before surgery.      The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or     placebo (inactive substance) as an infusion throughout surgery and for the first two days     thereafter. Neither the patient nor his or her physician will know if the patient is assigned     to study drug or placebo. Regardless of study assignment, both groups will receive standard     pain management medications and sedation.      After surgery, the patient's blood pressure, activity, posture, respiratory rate, the     electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and     respiratory rate will be continuously monitored and recorded for 48 hours using a wireless     pulse-oximeter and a respiratory volume monitor.      48 hours after surgery the patient will be asked to complete a patient satisfaction     questionnaire, which will allow the patient to rate the satisfaction with the treatment     received for pain. The patient will also be asked to complete a questionnaire about recovery.      At discharge, the patient will be given two questionnaires about pain and quality of life.   "
86323|NCT02156141|"     We want investigate if high intensity training can increase daily functionality without     causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if     there is a difference in effect with supervised and unsupervised training. Furthermore we     want to study if a supervised training program will motivate participants to continue     training by the end of the program.   "
86324|NCT02156128|"     The aim of this study is to examine if repetitive computerized cognitive training improves     working memory in patients who are on sick leave due to complex symptom disorders (chronic     pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of     cognitive control training transfer to other tasks.   "
86325|NCT02156115|"     Background:      - Lymphatics are a type of vessel, similar to arteries and veins. Lymphatic disorders happen     when these vessels don t work properly. Researchers want to look for a relationship between     lymphatic disorders and variations of certain genes found in the lung, blood, and other     places in the body.      Objective:      - To learn more about lymphatic disorders and evaluate how genetic factors affect lymphatic     disorders.      Eligibility:        -  People ages 2 90 who have a lymphatic disorder or relatives of people with lymphatic          disorders.        -  Healthy volunteers 18 and older.      Design:        -  Participants may have 1 2 visits a year, or more as needed. The study is expected to          last 5 years. Visits may last 1 5 days. Participants may have lab tests, medical          history, and physical exam at each visit.        -  Participants may have blood testing that includes genetics tests, and urine tests. They          may have nose and throat cultures, saliva collection, and cheek swabs to collect          samples.        -  Participants may have a skin biopsy and have blood taken from an artery.        -  Participants may have breathing tests and be studied while exercising.        -  Participants may have an electrocardiogram. Electrodes will be placed on their chest,          tracing heart rhythms. They may also have chest X-rays.        -  Participants may have a bronchoscopy. A thin, flexible instrument will be passed through          the nose or mouth, into the lung. A tissue sample will be taken.        -  Participants who have lymphatic disease or have a relative with it may also have:        -  CT scans. They will lie on a table and hold their breath while their chest is scanned.        -  MRI. They will lie flat on a table that slides in and out of a scanner.        -  ultrasound. A probe is rolled around outside the abdomen.        -  removal of fluid around the lungs, chest, and abdomen.   "
86326|NCT02156102|"     Background:      - People with sickle cell disease and other blood disorders sometimes get chronic leg ulcers.     These are wounds that develop on the skin and don t go away. Current treatments do not work     very well, so researchers want to learn more about why the ulcers happen. They want to find     out which bacteria may cause it, and if external factors play a role.      Objective:      - To study social and environmental factors of sickle cell disease and the causes of sickle     cell disease leg ulcers.      Eligibility:      - People age 18 and older who have sickle cell disease or another red cell disorder, with or     without an active leg ulcer.      Design:        -  Participants will have a medical history and clinical evaluation. They will also have          blood drawn.        -  Participants will complete questionnaires about their life, health, environment, stress,          and other topics.        -  Participants may provide a small sample of hair.        -  Participants will be asked to collect a small amount of saliva.        -  Participants with leg ulcers will have their skin microbiome sampled. The microbiome is          all of the microbes (bacteria and and/or fungi) and their genes in and on the body.          Researchers will use swabs to collect skin samples. Photographs will be taken of the          skin sample area.        -  Some participants without leg ulcers also will have their skin microbiome sampled.        -  Some participants who have their skin microbiome sampled will return for a second visit.          At this visit, their microbiome will be resampled. It will take place more than 30 days          after the first visit.   "
86327|NCT02156089|"     Background:      - People with attention-deficit hyperactivity disorder (ADHD) often have problems with     motivation and rewards. . Omega-3 fats have helped symptoms of ADHD improve in children.     Researchers want to learn more about the brain activity of people with ADHD and see how     taking omega-3 fats might help.      Objective:      - To learn more about how omega-3 fats affect brain activity and ADHD symptoms.      Eligibility:      - Adults age 18 55 with ADHD symptoms.      Design:        -  Participants will be screened with medical history and review of medical records.        -  For study visit 1, participants will have a medical examination and be interviewed to          confirm they have ADHD. They will have an IQ test and give blood and urine samples.          Height, weight, and blood pressure will be measured. They will also need to sign consent          to agree to take part in the study. They will be asked to complete a food diary for 4          days        -  For visit 2, participants will give a blood sample. They will complete questionnaires          about their mood and ADHD symptoms.. They may give a blood or saliva sample for genetic          testing.        -  Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table          that slides in and out of a metal cylinder. It makes loud noises; participants will get          earplugs. This scan examines the structure of the brain.        -  Participants will have a functional MRI scan. This scan measures the function of the          brain while the volunteer is performing tasks in the scanner. They will stop ADHD          medications 48 hours before this scan.        -  Participants will receive key-lime flavored omega-3 smoothie mix or placebo to takeevery          day        -  For visit 3, participants will give blood samples and complete questionnaires.        -  For visit 4, participants will be weighed and have a blood test and MRI scans as per          before. They will repeat the questionnaires and will guess whether they received the          omega-3 or placebo.   "
86328|NCT02156076|"     The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF)     through its effect on AF burden (AFB), or the percent of time in AF, in subjects with     paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg     QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD,     respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will     reduce AF burden as compared to baseline relative to placebo.   "
92979|NCT02069067|"     The purpose of this study is to describe how often advanced cancer patients experience     breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these     treatments are.   "
86330|NCT02156050|"     Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the     potential toxicity of bilirubin, newborn infants must be monitored to identify those who     might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or     kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants     during the first week after birth. However, in some babies the amount of bilirubin pigment     can increase to dangerous levels and require treatment. Treatment of jaundice in newborn     infants is done by placing them under phototherapy, a process of exposing their skin to light     of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as light     sources for phototherapy for many years. A light-emitting diode (LED) is a newer type of     light source which is power efficient, has a longer life and is portable with low heat     production. Several technologies and devices are developed around this LED and specially a     compact system.      The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with     conventional phototherapy (non-LED) and satisfaction of the parents and the professional     staff about comfort of this new technology. The newborn infant is placed in a sleeper with     the device B' bloo ® which maintains him in position (lap or dorsal) allowing to pass the     blue light. This one is generated by the module LED and transmitted in the braid of optical     fibers which takes place directly on the mattress of the cradle in which is placed the     patient usually.      The device is endowed with an hour counter to schedule the time of treatment. The energy     illumination varies between 3 and 4 mW / cm ² for an average 3,6 mW / cm ².   "
86331|NCT02156037|"     To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's     use of a diabetes dashboard with a usual diabetes team care condition (UDC) that does not     have access to the diabetes dashboard.   "
86332|NCT02156024|"     The purpose of this study is        1. To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of          masked hypertensive patients below 70 years.        2. To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.   "
86333|NCT02156011|"     The objective of this research is to synchronously assess in vivo loading data of the knee     joint, tibio-femoral 3D kinematics by means of automated video-fluoroscopy, whole leg     kinematics by means of skin markers, ground reaction forces, as well as muscle activity     patterns in 4 to 6 subjects with instrumented total knee arthroplasty (TKA) during dynamic     functional activities of daily life. The comprehensive in vivo dataset will provide unique     information to evaluate the relationship between the kinematics, respectively the alignment     of the TKA, and the resulting loading of the implant in vivo.      The whole data package will be made available for download on a public database, such that it     can be utilized for the testing and improvement of TKA designs as well as for the validation     and improvement of musculoskeletal modelling by researchers around the world.   "
86334|NCT02155998|"     This is a multicentre, non-interventional, prospective study to be carried out in     representative medical institutions in order to get the information on administration of     postoperative and post-radiation adjuvant androgen deprivation therapy (including go / no     go decision, regimens, dosages and duration) used in locally advanced prostate cancer     patients with high and very high risk of recurrence in Russia.   "
86335|NCT02155985|"     Since people started taking HIV medications, illness from AIDS has decreased, but other     serious diseases like heart disease, cancer, and kidney, and liver disease have increased.     HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured     by blood. Inflammation can lead to diseases that have become some of the leading causes of     death in people with HIV. HIV therapy can partially lower levels of inflammation measured in     blood, however, levels of inflammation in people who have HIV may remain high compared with     people not infected with HIV.      Aspirin is a drug that is commonly used for pain relief but is also approved by the Food and     Drug Administration (FDA) for preventing heart attacks and stroke in those who are at     increased risk for heart attack and stroke. Aspirin also is used (but is not approved by the     FDA) to decrease the risk of some cancers in people who are at increased risk. Aspirin is     thought to decrease risk of heart attack and stroke because it blocks the activation of     platelets and prevents blood clots from clogging narrowed blood vessels, a disease called     atherosclerosis. It is unknown how aspirin might decrease the chance of developing cancer in     some people at higher risk, but aspirin has been shown to modulate (or change) the immune     system. In HIV-infected people who have been taking antiretroviral therapy and have an     undetectable HIV viral load it was recently shown that low-dose aspirin 81 mg (baby aspirin),     given for one week, lowers platelet activation and reduces blood markers of inflammation     which may improve the function of the immune system.      The purpose of this study was to evaluate whether aspirin improves inflammation and immune     activation when compared to a placebo (inactive medication like a dummy pill) and to     determine if 12 weeks of aspirin 300 mg and aspirin 100 mg is safe for HIV-infected persons     on antiretroviral therapy. Additionally, it studied whether a higher dose and longer duration     of aspirin provides further anti-inflammatory and immune-modulating benefit. This was done     using blood and urine tests that measure inflammation and also with a test that uses     ultrasound to measure the flow of blood in your arm, called flow-mediated vasodilation (FMD)     of the brachial artery (BART). This is a painless test that bounces sound waves off of a     blood vessel in your arm.   "
86336|NCT02155972|"     This is an 8-week randomized, double-blind placebo-controlled proof of concept study     assessing the combination of a mood stabilizer + Align in the treatment of participants with     a bipolar depressive episode. The study has two treatment arms: mood stabilizer plus placebo     and mood stabilizer plus Align.      The dose of mood stabilizer will be in accordance with clinical practice guidelines and the     dose for Align will be 1 capsule per day as per appropriate product dosing.   "
86337|NCT02155959|"     Abstract Purpose: To evaluate the visual performance and rotational stability of the Tecnis     Toric one-piece IOL (AMO, USA) during the first 3 post-operative months Design: Prospective     single center study Setting: VIROS - Vienna Institute for Research in Ocular Surgery, a Karl     Landsteiner Institute, Hanusch Hospitel, Vienna, Austria Methods: In this prospective study     patients with age-related cataract and corneal astigmatism of 1.0 to 3.0 D measured with the     IOL-Master 500 (Carl Zeiss Meditec AG, Germany) were included. Pre-operatively, rotating     Scheimpflug scans (Pentacam HR, Oculus, Germany) were performed and the cornea was marked in     the sitting position at the slit lamp. Patients recieved a single-piece toric hydrophobic     acrylic IOL (Tecnis Toric, AMO, USA). Immediately and 3 months after surgery     retroillumination photographs were taken to assess the rotational stability of the IOL.     Additionally, Autorefraction (Topcon, USA), subjective refraction, uncorrected and distance     corrected visual acuity, keratometry, Scheimpflug and ocular wavefront (WASCA, Carl Zeiss     Meditec AG, Germany) measurements were performed at the 3 months follow-up.   "
86362|NCT02155634|"     The purpose of this study is to see how long lenalidomide therapy can maintain or improve the     disease response obtained after induction therapy that does not include lenalidomide,     pomalidomide or thalidomide; and consequently reduce worsening of disease and to evaluate the     activity of lenalidomide. Patients will receive lenalidomide or be under observation. All     patients will attend regular clinic visits to evaluate their disease and health. Patients     will have the option to participate in additional biomarker correlative studies in addition     to their participation in the main study.   "
86338|NCT02155946|"     The aging US population threatens to overwhelm our healthcare infrastructure, especially     since the rate of Alzheimer's disease (AD) alone is expected to triple in the coming decades.     Memory cause functional impairment, reduced quality of life, increased caregiver burnout, and     eventual institutionalization. The diagnosis of mild cognitive impairment (MCI) identifies     those with memory deficits but who remain relatively independent in everyday life. MCI     provides a window for interventions that target memory functioning. The proposed study     focuses specifically on a groundbreaking combination of mnemonic rehabilitation and     non-invasive brain stimulation. The main idea is that brain stimulation can enhance     functioning in the specific brain regions/networks, thereby increasing the patients' ability     to benefit from different types of memory rehabilitation. This will be a randomized,     double-blind study (active vs. fake brain stimulation), that provides multiple treatment     session. Outcome will be examined using both laboratory-based and real-world memory testing     as well as brain imaging. This first-of-its-kind study has the potential to meaningfully     translate more basic science findings into neuroanatomically targeted and functionally     meaningful treatments for our aging population.   "
86339|NCT02155933|"     Hormones are substances that are made by the body and are sent directly out into the     bloodstream to increase or decrease the function of certain organs, glands, or other     hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too     much testosterone in their blood. Too much testosterone in the blood can possibly lead to a     problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual     periods, excess facial and body hair, and too much testosterone in their blood. On the other     hand, some girls with too much testosterone in their blood do not develop PCOS. We do not     know why some of these girls develop PCOS and why some do not. The purpose of this research     study is to find out whether too much testosterone can cause problems with other hormones     that can lead to the development of PCOS. This study may help us understand more about the     causes of PCOS.   "
86340|NCT02155920|"     The purpose of this study is to evaluate the anti-tumor activity of Everolimus among children     with recurrent or progressive ependymoma. Recurrent or progressive ependymoma is incurable     and has very limited treatment options. The rationale for this study is based upon both     pre-clinical and clinical considerations: Immunohistochemistry studies have demonstrated that     20 out of 23 (87%) pediatric ependymomas are immunoreactive for phosphorylated S6, a     biomarker that often predicts response to mTOR pathway-targeted therapy. Furthermore,     children with with multiply recurrent ependymomas have had objective and durable responses to     the mTOR inhibitor, Sirolimus (Rapamune, Pfizer). As a result of this pre-clinical and     clinical data, this study will further investigate the activity of an mTOR pathway inhibitor,     Everolimus, against children with recurrent or progressive ependymomas. In this study,     Everolimus will be administered at a dose and schedule that have previously been demonstrated     as safe and effective in children. Children may take Everolimus for up to 2 years on this     study, until tumor progression or unacceptable toxicity.   "
86341|NCT02155907|"     Purpose        1. To validate 2 -day loop recording ( R.Test Evolution 4 ) to 2 -day Holter recording          (gold standard) for the detection of atrial fibrillation of ≥ 30 seconds duration in a          consecutive population of patients with stroke or transient ischemic attack (TIA).        2. To determine whether short run of atrial fibrillation (< 30s ) or the presence of many          supraventricular extrasystoles detected on Holter recording, is associated with risk of          re-stroke in a consecutive population of patients with stroke or TIA .        3. To test whether a 7-day Loop Recording (R -test) detects more patients with atrial          fibrillation than 2 days of Holter recording in a consecutive population of patients          with stroke or TIA.   "
86344|NCT02155868|"     Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used     to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy     has increasingly been used in perioperative setting of heart surgery and many studies have     outlined an increased incidence of postoperative morbidity in patients with significant     perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse     outcomes has been reported, there is not compelling evidence that interventions to correct     rSO2 during cardiac surgery lead to improved clinical outcomes.      Hypothesis of the study is that interventions to normalize intraoperatively decreased     cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk     cardiac surgery patients.   "
86345|NCT02155855|"     Investigators hope that providing patients and families with additional ways of communication     with the diabetes care team will improve diabetes control.   "
86346|NCT02155842|"     The purpose of this study is to determine whether endurance exercise of either high or     moderate intensity can reverse structural and functional changes of the heart in patients     with diastolic heart failure, and to investigate which type of exercise is best in terms of     aerobe capacity and quality of life.      The investigators expect that high intensity endurance exercise is superior to moderate     intensity endurance exercise.   "
86347|NCT02155829|"     The purpose of this study is to determine whether Riluzole is effective in the augmentation     treatment of post-traumatic stress disorder (PTSD) that is experienced by Active Duty     military service members and Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF),     and Operation New Dawn (OND) veterans who have not had symptom reduction after one or more     kinds of medications or therapies.   "
86348|NCT02155816|"     The purpose of this study is to determine if supplementation with a mixture of omega 7 and 3     fats has a favorable influence on blood inflammation and lipoprotein biomarkers in women with     systemic inflammation compared to omega 3 and placebo.   "
86349|NCT02155803|"     ACTHAR Gel has activity in sarcoidosis associated hypercalciuria and calcium dysregulation.   "
86350|NCT02155790|"     The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device     which is intended to be used to ablate the afferent and efferent sympathetic nerves serving     the kidneys. The catheter is typically inserted via the femoral artery, steered into the     renal artery, and then delivers, by infusion from its distal end, a neurolytic agent. This     targets the nerve bundles, which are in the adventitia - a sheath surrounding the artery. The     aim is to reduce blood pressure in cases of resistant hypertension - seriously elevated blood     pressure which does not respond to drug treatment.   "
86351|NCT02155777|"     Use of oral contraceptives (OCs) reduces a woman's risk of ovarian cancer very significantly     and the protective effect continues for at least 25 years after use of OCs is stopped; the     mechanisms of how this occurs are not understood. We are proposing here to directly study the     effect of OCs on the fallopian tube and inclusion cysts within the ovary - sites from which     most ovarian cancers are thought to arise - in order to better understand the mechanistic     basis for OC protection against ovarian cancer. We think the protection results from reduced     cell proliferation. It will lay the foundation for further studies to ensure that the     protection against ovarian cancer afforded by 'traditional' OCs is not lost with alterations     in OC formulation, and, if possible, to guide development of OC formations to improve further     on the protection afforded by OCs.   "
86352|NCT02155764|"     Return to normal life and shortening rehabilitation period of patients after surgical removal     of teeth is important and urgent social problem. In this regard, higher demands for quality     of care and treatment of patients, which requires the development of new approaches to the     treatment of patients, the introduction of new technologies and the associated development of     new materials . Serious problem of contemporary oral and maxillo-facial surgery and dentistry     is augmentation of bone defects generated during the surgical treatment of diseases and     injuries of the bones. The results of surgical repair of bone defects are more dependent on     the course of the process of reparative osteogenesis. Long-term periods of clinical studies     indicate that reparative osteogenesis in posttraumatic bone defects is slow - months and     years, and in some cases no bone defects filled with bone tissue.      This project aims at addressing the preservation of bone volume in humans after tooth     extraction using biomaterials with optimum performance. The practical significance of the     project is to establish an effective tissue response and, thus, possible subsequent quality     installation of dental implants. The proposed solution is based on the scientific development     of the operative techniques, and a comparative analysis of several classes of biomaterials     (xenogenic and synthetic analogs), including the use of biological precursors of bone apatite     mineralization having osteoinductive (stimulating) properties.   "
86353|NCT02155751|"     This is a pilot project in which investigators will recruit obese (pre-pregnancy BMI of ≥ 35     kg/m2) women from the newly developed My Clinic at London Health Sciences Centre as well as     normal obstetrical care at London Health Sciences Centre.      Patients will be randomized to one of three treatment groups: 1) the full Nutrition and     Exercise Lifestyle Intervention Program (NELIP), 2) Nutrition program only, or 3) Exercise     program only.      The investigators hypothesize that the evidence-based NELIP for obese pregnant women will be     feasible to adopt in a clinical setting and will prevent excessive gestational weight gain,     gestational diabetes and promote healthy infant growth patterns at the 6 and 12 month     milestones. Outcomes may be improved in My Clinic over normal obstetrical care patients with     interprofessional services.   "
86354|NCT02155738|"     The purpose of this study is to determine whether preoperative IV Acetaminophen reduces     postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic     organ prolapse.   "
86355|NCT02155725|"     The purpose of the study is to assess the benefits of a therapeutic strategy that associates     an early administration of human fibrinogen concentrate in the management of PPH on the     reduction of bleeding after the initiation of prostaglandins intravenous infusion, following     vaginal delivery.   "
86356|NCT02155712|"     The success rate of the Triathlon Tritanium Knee, defined as absence of revision for aseptic     loosening of the tibial baseplate at 2 years, is no worse than rates reported in the     literature for cemented devices.   "
90844|NCT02097030|"     The objective of the study is to compare the overall subjective preference of filcon II 3     daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A     daily disposable conventional hydrogel contact lenses.   "
86357|NCT02155699|"     The goal of this proposal is to test the feasibility and effectiveness of cardiovascular     exercise in promoting brain health and improving related symptoms (e.g., hearing sounds that     are not there, feeling emotionally detached from self and others), cognitive difficulties     (troubles with memory and learning), and every day social-occupational functioning in youth     at imminent risk for developing a psychotic disorder such as schizophrenia. Understanding how     exercise may protect or improve the health of a brain area that is implicated as a major     contributing factor to the onset of psychosis may lead to a path-breaking new intervention     that does not suffer from many of the side effects, costs, and other barriers that     characterize treatments that are currently available for this group. Because a significant     portion of high-risk youth go on to develop a psychotic disorder in a short period,     intervening at this stage may help to improve the clinical course and ultimately prevent the     onset of a devastating and prevalent mental illness.   "
86358|NCT02155686|"     The elderly or people with disabilities want to remain in their homes even when their health     condition has been getting worse.      This project aims to demonstrate that home automation and telemonitoring can lead to develop     a home safety environment that could help the elderly and individual with disability live     independently in their own home.      In this study, the automation sensors containing devices follow up chronic disease clinical     factors to monitor their biometrical parameters and detect any abnormal prodromal disease     decompensation via telemonitoring and geriatric expertise.      The purpose of this study is:        -  to provide clinical evidence of the effectiveness of automation tools and          telemonitoring/expertise for the home support for people at risk of loss of autonomy        -  to demonstrate the clinical benefit of combining the automation and telemonitoring and          geriatric teleexpertise   "
86359|NCT02155673|"     The primary objective of this study is to determine the safety and tolerability of extended     dosing of GCS-100 in patients with CKD.   "
86361|NCT02155647|"     This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the     efficacy and safety of avelumab in subjects with metastatic Merkel cell carcinoma (MCC).   "
86363|NCT02155621|"     The genomic heterogeneity of cancers implies that to effectively use targeted therapies the     investigators will need to assess each individual cancer and match it to a biologically     relevant targeted therapy. The investigators will use full genome sequencing to try to     identify cancer drivers and corresponding drugs that may inhibit these pathways.   "
86365|NCT02155595|"     The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone)     fractures after long term fracture prevention therapy with a class of drugs called     bisphosphonates, colloquially referred to as Alendronate, risedronate, Ibandronate, and     Zoledronate.      In addition, the study is designed to find out which patient is most likely to develop this     potential life changing complication and why. Finally, the results of this study will help     clinicians to better understand the reason and thus tailor patient specific treatments…i.e.,     the right treatment for the right patient for right duration.   "
86366|NCT02155582|"     This study aims to analyze what the study drug does to the body and its relationship to drug     levels and safety after patients with advanced cancer have been treated with copanlisib in     different dose groups.   "
86367|NCT02155569|"     The aim of the study is to compare post operative morbidity between extra peritoneal cesarian     and trans peritoneal cesarean section.   "
86368|NCT02155556|"     Aim of this study is to gain a better understanding of the diurnal changes of the cornea to     improve toric IOL power calculations.   "
86369|NCT02155543|"     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in     healthy subjects.   "
86370|NCT02155530|"     This study is a prospective randomized trial to evaluate and compare the quantitative and     qualitative characteristics of neointimal formation between high and low efficacy statin     treatment after drug eluting stent (DES) implantation, in patients with homogeneous or     heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The     investigators postulate that high efficacy statin could have superior effect on modification     of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that     Atorvastatin 40mg, high efficacy statin might have superior effect on modification of     neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in     patients with DES implantation.   "
86371|NCT02155517|"     Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more     complete published until now. Schnider was derived from 24 healhty people, and including     other covariates in addition to weight, such as age, height and lean body mass though.     Schnider model should not be used in obese patients. Cortínez model was derived from 20 obese     patients. The differences between both models has been founded at the initial drug     distribution, that means V1 and the constant Ke0 ( pharmacokinetics factors that define the     plasma-effect equilibration time). We believe that Cortinez model also could be used in No     OBESE patients because is an allometric model, and one way to evaluate and to compare both     pharmacokinetics models is studying the temporary course of the effect.      The main objective of our study is to evaluate BIS and Cardiac Output values during     propofol-induced sedation using Schnider and Cortinez models in Target Controlled infusion in     non obese healthy volunteer.   "
86373|NCT02155491|"     The protocol is a large registry to describe acute, sub-acute and extended duration of     anticoagulation management, clinical and economic duration of anticoagulation management,     clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the     real-world setting.      Main objectives are to clarify the:        -  treatment related details for acute VTE (either conventional anticoagulation therapy,          treatment with a direct oral anti-coagulant or other modalities of treatment)        -  Rate of early and late symptomatic VTE recurrence        -  Rate and nature of complications of VTE including post thrombotic syndrome and chronic          thromboembolic pulmonary hypertension        -  Rate of bleeding complications        -  Rate of all-cause mortality at six months   "
86374|NCT02155478|"     The pseudoexfoliation (PXF syndrome) is caused by production and deposition of extracellular     material in the anterior chamber of the eye as well as in other tissues of the body. Approx.     70 million worldwide have a PXF syndrome.      After cataract surgery a decentration and subluxation of the intraocular lens (IOL) happens     more frequently than in the general population due to a higher incidence of zonular weakness     and an increased capsular fibrotic reaction.      Decentration, tilt and / or rotation of the lens can reduce the quality of vision.      It is believed that the design of the implanted IOL, more precisely the front surface of the     IOL has an influence on the extent of capsular fibrosis and contraction. Especially in     presence of capsular instability, as it is in patients with Pseudoexfoliation syndrome the     design of the IOL has an effect on the post-operative stability.      In this study, two different IOL models are compared in terms of their stability. The Tecnis     1-piece ZCB00 (AMO, USA), with a concave lowering comprising the lens edge and the Acrysof     SA60AT (Alcon, USA), with a biconvex design are compared. Forty eyes of 20 patients are     planned to be included in this study. One eye receives the Tecnis ZCB00 1-piece (AMO, USA),     while the other eye receives theAcrysof SA60AT (Alcon, USA).      In which eye which IOL is implanted, is assigned by randomization. To measure the     decentration, tilt and rotation of the IOL an examination will be performed before the     operation and there will be follow-ups one hour after the operation of the first eye, one     hour after the operation of the second eye, three months and twelve months after the     operation on the second eye. All measurements will be done without touching the eye.   "
86375|NCT02155465|"     This is a phase 2 study. The goal of this study is to find out what effects, good and/or bad,     taking erlotinib and ruxolitinib has on the patients and on lung cancer. Erlotinib and     ruxolitinib are FDA approved for other indications, but the use of erlotinib and ruxolitinib     together has not been studied before and is not FDA-approved.   "
86376|NCT02155452|"     The investigators aim to study the heterogeneity of fluorescence within malignant gliomas by     sampling tissues from these variable areas within the same tumor. These tissue samples will     then be subjected to pathological and biological analysis to assess proteins related to ALA     metabolism and correlated with the fluorescence emitted as well as levels of protoporphyrin     IX in the tissues.   "
86377|NCT02155439|"     The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid     disease treatment.   "
86543|NCT02153268|"     Phase I/II open label first in human single center clinical study, is to evaluate the safety     and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose     tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area     approximately 6 month follow up after implantation in the following two clinical indications:        1. Bone augmentation (e.g. sinus augmentation)        2. Bone grafting after removal of cysts from jaws   "
86378|NCT02155426|"     TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change     of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy      BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in     oncology, and some studies have been conducted with success on breast and prostate cancer.     Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC     identification and monitoring these cells after treatment could help the clinicians to detect     relapse or be a prognostic factor.      PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of     treatment (Overall response rate and Progression-free survival).      SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival.      STUDY DESIGN : This is a prospective, observational study.      Duration of the inclusions: 12months.      SAMPLE SIZE : 1200 patients   "
86379|NCT02155413|"     Acute pain service (APS) was introduced in 1990s at Queen Mary Hospital (QMH) as other     countries. With accumulation of experience and clinical evidence, APS has been well     established. A study conducted in 1997 suggested that monitoring, management protocol and     nursing experience were mandatory to the safety for APS. Our recent study showed that pain     relief of our post-operative patients using patient controlled analgesic with morphine was     still not adequate. The results has driven us to continue the improvement of post-operative     outcomes for our surgical patients. Tolerability and safety are always our concerns for     patients using our APS. Therefore, the investigators aim to conduct this retrospective study     in order to assess if the tolerability and safety of our present APS are adequate or not. The     study results will help us to further improve our APS at QMH if necessary.   "
86380|NCT02155400|"     Getting cold (not maintaining normothermia) around surgery (perioperative period) leads to     many negative outcomes for patients including increased wound complications, abnormal heart     rhythms and increased blood loss. These all lead to increased length of hospital stay and     higher requirements for post operative monitoring. These add to around $3500 of extra costs     per patient. The investigators aim to study the effects of a warming device, placed around     the patient's legs and/or feet, to determine it's safety, efficacy and eventually compare to     the current gold standard of a forced air warming blanket. Forced air warming has been     associated with the spread of germs over the surgical field. Hence the need for warming     equipment that won't do that.   "
86389|NCT02155283|"     The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive     motion home-use device in relieving low back pain, improving proprioception (balance and fall     prevention) and improving the symmetry of muscle function on either side of the spine.   "
86390|NCT02155270|"     We would like to evaluate the use of a 600μm pre-cut regarding wound architecture and     surgically induced astigmatism as compared to a stab-incision (a corneal incision without a     pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration.      Postoperatively, OCT scans will be obtained, corneal curvature will be measured and     subjective and objective refraction will be performed in order to measure the     surgically-induced astigmatism.   "
87608|NCT02139332|"     The purpose of this study is to to conduct a randomized controlled trial comparing an     intervention group and a control group to evaluate the feasibility of the Promoting First     Relationships method in an American Indian community through their tribal Health Promotion     program, and to assess the efficacy of the method in this community.   "
86381|NCT02155387|"     The use of cardiopulmonary bypass (CPB) combined with one lung ventilation (OLV) allows to     perform minimally invasive cardiac surgery (MICS) through small incisions. MICS is described     to be associated with similar outcomes compared with conventional surgery. Although less     invasive, MICS has not been reported to favorably impact the incidence of respiratory failure     after surgery.      The combination CPB and OLV may induce acute respiratory distress syndrome (ARDS). After CPB     contact of blood components with the artificial surface of the bypass, lung ischemia     reperfusion injury (LIRI) and operative trauma may trigger a systemic inflammatory response     syndrome (SIRS). During OLV, ARDS can result from hyperoxia, hyperperfusion and ventilatory     distress in the ventilated lung as well as from LIRI and operative trauma of the collapsed     lung.      Extravascular lung water (EVLW) includes all fluids in the lung except for those in the     vascular compartment. An excess of EVLW may lead to respiratory insufficiency. This may be     due to an increased hydrostatic intravascular pressure, as it occurs in cardiogenic pulmonary     edema, and/or by an increase of lung endothelial and epithelial permeability, as in ARDS. The     extravascular lung water index (EVLWI) assessed by the transpulmonary thermodilution     technique may be a useful tool for accurate diagnosis of ARDS, and the pulmonary vascular     permeability index (PVPI) may help in the differentiation between pulmonary edema due to an     increase in the pulmonary capillary permeability versus an increase in the pulmonary     capillary hydrostatic pressure.      As both CPB and OLV may induce an excess of EVLW, the investigators hypothesize that patients     after MICS with intraoperative combination of CPB and OLV may have higher EVLWI and PVPI than     those who received either CPB or OLV alone.   "
86382|NCT02155374|"     Objective: to determine which regimen results in best glycemic control and safety profile,     expressed as glucose values within target range and occurrence of hypoglycemia. Secondary     objective is to compare patient satisfaction, clinical outcomes and toxicity.      Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years,     who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of     antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of     chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent     glucocorticoid and a wash-out period of 4-38 days between each cycle.      Intervention: subjects will be treated by insulin regimen A and B in random order during two     consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg     prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin     according to sliding scale regimen, dose adjusted to current grade of hyperglycemia.      Main study parameters: Difference in fraction of blood glucose measurements (BGM) within     target range and occurrence of hypoglycemia.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Both study treatments are just a slight variation in regular care for     glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to treatments     and increased counselling. All subjects will receive both treatment regimens.      The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1     venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3 months     before start), and 1 randomization visit to the outpatient clinic. Potential risk is the     occurrence of hypoglycemia, as is present in any insulin therapy. The investigators account     for this risk by giving subjects dietary advice and education how to prevent, recognize and     treat hypoglycemia.   "
86554|NCT02153125|"     The aim of the study is to determine the efficacy and safety in treating patients with     chronic central serous chorioretinopathy with the drug eplerenone.   "
86383|NCT02155361|"     This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in     treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind     placebo-controlled clinical trial design. This study includes 60 patients from SUMS     endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as     radiculopathies will be excluded. After giving the Informed consent the patients will be     underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They     will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic     Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire     and electrodiagnostic criteria will be evaluated.   "
86384|NCT02155348|"     More and more patients like to achieve complete spectacle independence after cataract     surgery. Two possibilities that are particularly often used today are on the one hand     multifocal lenses, and on the other hand the concept of monovision (in doing so one eye is     adjusted for closeness and the other focuses for distance). The drawback with multifocal     lenses is that some patients are bothered by glare phenomena, the disadvantage of monovision     is that some patients lose a little of their stereo vision.      The aim of this study is a direct comparison of these two methods. Therefore 70 patients are     included in 2 groups. In one group, patients receive on both sides a multifocal IOL with a     near addition of +1.5 D and the patients in the second group receive monovision. One hour, 1     week and 3 months after surgery, patients are invited and tests for visual accuity are     performed for near vision (40cm), intermediate vision (80cm) and distant vision (400cm).     Furthermore, contrast sensitivity and stereopsis of patients is assesed. Additional     measurements for detecting the tilt of the lens will be performed.   "
86385|NCT02155335|"     This study is designed to determine whether ulcerative colitis participants prefer delivery     of golimumab via a prefilled syringe or the Smartject™ device.   "
86386|NCT02155322|"     This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant     treatment for melanoma.   "
86387|NCT02155309|"     Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval     Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time     to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the     efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.   "
86388|NCT02155296|"     The Restorative Practices Intervention (RPI), is a whole school environment intervention     which is integrated into existing school practice (rather than 'added on') so does not     compete with academic priorities; and it has some evidence supporting its effectiveness at     improving school environment and promoting positive peer relationships. The specific aims of     this investigator initiated study are to:        1. Assess the mechanisms of how RPI implementation influences the school environment;        2. Assess the effects of RPI on school staff perceptions of school climate and adolescents'          reports of school connectedness, peer relationships, developmental outcomes (academic          achievement and social competency) and problem behaviors (alcohol use, bullying,          disciplinary referrals);        3. Assess the extent to which the positive effects of RPI on adolescents persist over time          during the transition between middle and high school.      For the first time utilizing rigorous scientific methods, this study has the potential to     document whether a whole-school intervention like RPI, that can be integrated into existing     school practice, can affect both developmental outcomes and problem behaviors and whether the     effects persist during the transition from middle to high school.   "
87609|NCT02139319|"     The purpose of the study is to evaluate the safety and tolerability of the drug product at     each dose level.   "
86391|NCT02155257|"     The purpose of this research study is to test whether or not researchers can alter or change     expectations on pain. The researchers will test whether there is an effect on the size of the     pupil and responses to thermal heat temperatures in subjects with osteoarthritis of the knee     or hip or healthy subjects for comparison.      One of 3 possible treatment groups will be administered to qualifying subjects: (1)     gabapentin, a medication that is commonly used to treat nerve pain, (2) modafinil, a     medication that is commonly used to treat people with narcolepsy (a disorder that causes     people to fall asleep) and (3) a placebo, which is an inactive substance, like a sugar pill,     that is not thought to have any effect on your disease or condition   "
86392|NCT02155244|"     In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified     after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this     study is to determine leaving the gallbladder in situ does not reduce the morbidity rate     after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.   "
86393|NCT02155231|"     OBJECTIVES        1. To determine the prevalence and incidence of anal HPV infection, including infection          with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.        2. To study the prevalence and incidence of HGAIN among these MSM.        3. To evaluate risk factors, including HIV status, for anal high-risk HPV infection and          HGAIN among these MSM.      Study population An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the     study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also     enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT     study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this     study.   "
86412|NCT02154984|"     The purpose of this study is to study the relationships between obesity, hormones and     menopausal status, and breast cancer. The researchers would like to study whether a type of     nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a     smartphone application; the researchers also want to study the effect that a tRD has on     weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to     restrict their daily eating to a specific time frame each day. The researchers think that     this might be an effective and manageable way to control weight.   "
86555|NCT02153112|"     The purpose of this study is to select the optimal formulation of the norovirus vaccine from     different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for     further development in children.   "
86556|NCT02153099|"     The purpose of this study is to characterize the safety and tolerability profile of     escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose     in healthy adults.   "
86394|NCT02155218|"     In Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) a contrast agent is injected     into an arm vein using a programmable medical device called a power injector. Once the     contrast has circulated to the blood vessel of interest they can be imaged with MRI and     distinctly separated from surrounding non-vascular tissue.      This project is designed to find the best way to administer the contrast agent during CE-MRA     to produce the best images. The clinical availability of programmable power injectors     facilitates the use of variable contrast rate and volume injection protocols that are based     on patient specific parameters.      CE-MRA is a valuable imaging tool for diagnosing abnormalities of the major blood vessels in     the chest and abdomen. It is often used in conjunction with cardiac magnetic resonance (CMR)     examinations to evaluate the blood vessels of the heart and lung. CE-MRA is attractive     because 1) it does not involve radiation, and 2) the contrast agents used are not toxic to     the kidneys and can be used in patients who are at greater risk for kidney dysfunction     following iodinated contrast agents.      We plan to administer a small (1cc) test amount of contrast, taking pictures as the contrast     passes through the blood vessels, and analyze the results. Using this information, we will     administer an individually patient-tailored injection given in multiple phases (i.e., a     multi-phasic injection) to maintain constant contrast concentration (and therefore constant     signal intensity) throughout the scan. We believe this will reduce image blurring, and     improve the sharpness and likely the diagnostic quality of CE-MRA.   "
86395|NCT02155205|"     The purpose of this study is to demonstrate that telotristat etiprate does not differ from     placebo in the mean change from Baseline QT interval corrected for heart rate.   "
86396|NCT02155192|"     The purpose of this study is to evaluate the association between genetic factors and response     to treatment (guselkumab, ustekinumab, adalimumab, or etanercept) and psoriasis (scaly skin     rash).   "
86397|NCT02155179|"     The embryo kinetics may be a new prognostic factor for choosing the embryos with the highest     implantation potential. In order to identify the factors that may affect the rate of embryo     cleavage, there are many studies about morphokinetics and culture medium, oxygen tension,     oocyte quality or type of medication used for ovarian stimulation. However there are no     published data with respect to the influence of semen quality in the embryo kinetic.      In this study The investigators propose that the sperm quality may has influence in the     embryo division.   "
86398|NCT02155166|"     This study has the objective to evaluate the effect of Injectable intracervical anesthesia in     comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately     after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women     without previous vaginal delivery.      H0: There is no difference in terms of pain score between the treatments H1: There will be     difference in terms of pain score between treatments   "
86399|NCT02155153|"     Postoperative ileus is generally referred to as the transient impairment of bowel motility     after abdominal or other surgery and diagnosed by postoperative abdominal pain vomiting     constipation and distension.      The potential complications of prolonged POI include increased postoperative pain, increased     nausea and vomiting, pulmonary complications, poor wound healing, delay in resuming oral     intake, delay in postoperative mobilization, prolonged hospitalization, and increased     health-care costs. The estimated economic impact of POI in the United States is $7.5 billion     per year, excluding the expenses of work loss.      In view of these complications and economic burden a number of pharmacologic and     non-pharmacologic strategies have been adopted by the doctors all over the world to reduce     the burden of postoperative ileus.These programs involve transverse or curved surgical     incisions, removal of nasogastric tubes at the end of anesthesia, intraoperative and     postoperative analgesia, early postoperative feeding, mobilization, and gum chewing.      The use of gum chewing has emerged as a new and simple modality for decreasing POI. And     reviews have concluded that there is consistent benefit for patients from gum chewing after     the intestinal surgery; colonic surgery and gynecological surgery.      This study is based on the hypothesis that postoperative gum chewing is beneficial in     prevention of postoperative ileus after reversal of ileostomy.   "
86407|NCT02155049|"     Prostaglandin analogues eye drops are common and effective treatment for decreasing     Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports     have documented periorbital fat atrophy following treatment by prostaglandin analogues. In     this study the investigators want to use this side-effect of prostaglandin analogues for the     treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED)     patients, as a conservative substitute for surgical intervention.   "
86400|NCT02155140|"     Patients due to undergo surgery for oesophageal and gastric malignancy are often     malnourished. Up to 10% of patients preoperative weight may also be lost during the early     postoperative period. Following discharge from hospital the mechanics of the surgery leads to     a loss of gastric reservoir function, lack of appetite, altered intestinal motility and     gastro-oesophageal reflux which usually results in reduced dietary intake and further weight     loss. In patients who have undergone upper gastrointestinal resections there are no studies     examining the benefit of nutritional supplementation following hospital discharge, however,     studies in other groups of surgical patients have failed to show benefit. Despite patients     who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no     evidence demonstrating the value or not of nutritional supplementation following hospital     discharge.      Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will     exacerbate the reduced quality of life and fatigue patients' already experience. The     investigators hypothesise that improving patient's nutritional intake following hospital     discharge will improve their quality of life and fatigue levels.   "
86401|NCT02155127|"     Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the     U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million     individuals. Impairments in physical function and mobility limitations have been reported in     older Chronic Kidney Disease patients, however the consequences of impaired functioning on     participation in daily life and quality of life have not been studied. Early identification     and interventions to mitigate deterioration in physical function and mobility should lead to     improved health and quality of life outcomes in older patients with Chronic Kidney Disease.     Although older individuals with Chronic Kidney Disease have reduced survival expectancy,     maintaining physical function and mobility may contribute to longer active life expectancy,     and higher quality of life despite their diagnosis.   "
86403|NCT02155101|"     The aim of this pilot study is to assess the feasibility, efficacy and safety of     Darunavir/ritonavir 800/100 mg once daily (DRV/r) monotherapy as a switch-maintenance     strategy for patients receiving second-line ART at Yaoundé Central Hospital in Cameroon.     HIV-infected adults receiving second-line antiretroviral therapy (ART) for ≥3 months with 2     nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir     (LPV/r) or atazanavir/ritonavir (ATV/r) will undergo plasma HIV-1 RNA (viral) load testing.     Those with a viral load below 50 copies/ml (<50 cps/ml) will undergo a repeat test ideally     4-6 weeks later (allowed up to 12 weeks); if the viral load is confirmed as <50 cps/ml the     patient will be invited to join the randomised phase of the study. Patients (n=150) will be     randomised 1:2 to either continue the current triple ART regimen (n=50) or switch to DRV/r     monotherapy (n=100). The primary end-point will be viral load suppression <400 cps/ml at week     24; secondary end-points will be viral load suppression <50 cps/ml at week 12 and week 24,     safety, tolerability, and emergence of protease inhibitor (PI) drug-resistance. Patients will     continue observational follow-up depending on the treatment arm they are randomized to. After     week 48, patients will return to local standard of care. Pharmacokinetics (PK) and     pharmacogenomics sub-study to correlate plasma concentrations of DRV to outcomes, HIV-1 drug     resistance testing sub study to detect mutants archived at the time of first-line ART failure     and measuring HIV DNA load will be performed, as well as a cost-effectiveness analysis will     test the hypothesis that savings can be achieved by switching to DRV/r monotherapy without     affecting quality of care. The primary virological objective is to evaluate efficacy in terms     of the percentage of subjects who have plasma HIV-1 RNA levels <400 cps/ml after 24 weeks of     follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing     2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method).      Study hypothesis:      we propose that maintenance therapy with DRV/r monotherapy is a feasible, effective and safe     treatment option for patients receiving second-line ART in Yaoundé.   "
86404|NCT02155088|"     The main purpose of this study is to see primarily if BYL719 is safe to be given to patients     in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an     FDA-approved regimen to treat pancreatic cancer. Secondary goals will be to find out the     effect on tumor of this new drug combination of BYL719, gemcitabine and nab-paclitaxel. In     the first part of the study, different doses of BYL719 will be tested. In the second part of     the study, all patients will be started at the same dose of BYL719.   "
86405|NCT02155075|"     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology     using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D     metabolic maps of the breast and based on sophisticated machine learning technology, provides     objective risk assessment for the presence of malignant tumor in the breast. The procedure is     non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring     infrared images of the breast. Those images are processed and analyzed by computers to     provide the objective risk assessment.      The technology is intended to be used as a screening tool for breast cancer and emerges as     highly useful in women for whom screening mammography is sub-optimal, such as women with     dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating     patients with mammographically dense breasts.      The purpose of this clinical study is to assess the ability of this novel technology to     detect breast cancer in women.   "
86406|NCT02155062|"     Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye     grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in     measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are     absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable     biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting     this proposal. Different AR species are present in characteristic quantities in WG wheat in     comparison to WG rye cereals, which can allow identification of the main source of WG (wheat     or rye) in individuals by analysing the AR concentrations in blood. However the patterns of     urinary AR metabolite excretion following wheat or rye intake have not yet been investigated     to determine if there are differences according to WG source.      The present study aims to:      (i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine     samples after following a predominantly WG rye-based diet in comparison to a predominantly WG     wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the validity     and reproducibility of AR metabolites in spot urine samples in comparison to 24 hour urine     samples.   "
86429|NCT02154763|"     This is a pilot study in a randomized, controlled, double-blinded format and will evaluate     the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass     surgery. The drug will be administered into the abdomen during a bariatric bypass surgery.     After surgery, patients who received Ropivacaine will be compared to those without     Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to     walk, and quality of life during recovery.   "
86408|NCT02155036|"     The proposed research aims to examine whether regular aerobic exercise can preserve renal     function, improve aerobic capacity, physical and psychosocial function, strength,     cardiovascular function, general well-being and quality of life. Ultimately, the research     aims to prove that exercise is a more cost-effective and a more efficient use or healthcare     resources used in the treatment of patients with CKD. Exercise is a relatively cheap     treatment option which is readily available and accessible for this patient population.     establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;        1. Preserves renal function.        2. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular          function, general well-being and quality of life.   "
86409|NCT02155023|"     Two new glucose sensors (IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM,     Germany)) will be investigated to determine the optimal calibration method in patients with     type 1 diabetes   "
86410|NCT02155010|"     Patients were randomized into two groups, A group and B group. A group and B group patients     are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy     bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine,     respectively.      The investigators will compare of hemodynamics and patient's comfortability between two     groups.   "
86411|NCT02154997|"     During pregnancy nutrition demands change and the pregnant woman needs to adjust her food     intake and take into consideration the corrected daily recommendations for micro and macro     nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice.      Amongst pregnant women with Diabetes the glucose balance is extremely important during     pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin.     This delicate balance requires from the pregnant women an ability to perform correct     carbohydrate count.      Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes.     Hypoglycemia may also have a negative effect but the main danger is immediate harm to the     mother and therefore to the fetus. For those reasons glucose balance is crucial and demands     delicate synchronization of nutrition and insulin therapy.   "
86413|NCT02154971|"     The ageing process is known to be accelerated in HIV-infected patients, compared to the     general population.      Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than     70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial     damage caused by oxidative stress.      Risk factors for accelerated age-related hearing loss are present in many HIV-infected     patients : chronic inflammation, smoking, diabetes, etc.      The global aim is to measure the prevalence of presbyacusia in a well controlled HIV positive     population in France, and to compare it to HIV negative controls matched for age and sex.      90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a     screening for presbyacusia (pure-tone, speech and evoked-response audiometry).      We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as     compared to controls matched for age and sex.   "
86414|NCT02154958|"     300 women with unexplained infertility who are already decided to be treated with ICSI will     be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.      On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed     and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC     will be defined as the number of follicles measuring 3-10mm.      All patients will have standard pituitary down-regulation followed by (Human menopausal     gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG)     administration. On the day of HCG administration, ovarian ultrasound scan will be performed     using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC)     is defined as number of follicles measuring≥16mm. FORT will be calculated as: (PFC) *     100/AFC.   "
86415|NCT02154945|"     Purpose:      Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness     changes during pregnancy by Optical coherence tomography      Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in     participants who develop systemic or ocular complications during the study period.   "
86416|NCT02154932|"     Introduction: The study aimed to investigate the effectiveness of a single versus double dose     of Prostaglandin E2 Misoprostol, 400 microgram during myomectomy for multiple uterine     fibroids. This was a prospective randomized controlled trial comprised of 69 patients with     multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal     single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2     doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and     post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature     were estimated and compared in both groups.   "
86417|NCT02154919|"     To compare the different effect of conservative pharmacotherapy and Staged Percutaneous     Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment     elevation myocardial infarction (STEMI) at presentation remains controversial   "
86418|NCT02154906|"     Inflammatory periodontal disease often results in loss of bone around the teeth. Bone defects     that have a certain size and shape (called intrabony or intraosseous defects) may be improved     by using a graft material in the bony defect. The purpose of this study is to compare healing     of periodontal intrabony defects that are treated using demineralized freeze dried bone     allograft (DFDBA) versus autogenous platelet-rich fibrin.      The null hypotheses is that there will be no significant differences in bone fill, CAL gain,     PD reduction or recession at sites treated with PRF compared to sites treated with DFDBA.   "
86419|NCT02154893|"     There are several therapeutic effects of the ultrasound (US) or low level laser therapy     (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory     response and accelerated tissue repair. The investigators hypothesis was that a combination     of US, LLLT and therapeutic exercise may maximize clinical outcome.   "
86420|NCT02154880|"     Hypothesis;Aging modifies the risk of pulmonary dysfunction in HIV+ individuals.      The study is a multicenter, prospective observational study of aging and pulmonary function     in HIV. The investigator will determine the prevalence and risk factors for lung dysfunction     as quantified by pulmonary function testing in both younger (<50 years) and older (≥50 years)     HIV+ and HIV-uninfected controls. The investigator will build on existing cohorts and enrich     enrollment for individuals over the age of 50 while adjusting for important co-variates such     as ART, smoking history, co-infections, and illicit drug use. Evaluations will be scheduled     at baseline, 18 months, and 36 months. Study visits will consist of blood draw,     questionnaires, and pulmonary function testing.   "
86421|NCT02154867|"     Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded     Placebo Controlled Trial - the REFIT project      Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like     diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of     life and increased sickness absence. The prevalence of IBS in the general population may be     as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS     is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other     less well founded theories have been stated. So far, no measurement or test can affirm     diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern     according to the Rome classification can set the diagnosis.      Earlier non-controlled case reports have shown a convincing effect of fecal microbial     transplantation (FMT) in IBS patients. However, no placebo controlled trial has been     performed in this condition. Changes in the gut microbiome may be an important factor in IBS     pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may     trigger changes in visceral sensibility and pain perception.      The fecal microbial transplantation (FMT) procedure has been used primarily to treat     clostridium difficile infections. Few minor side effects have been reported.      Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by     transplanting a microbiome sample from a healthy donor.      Aim of study:        -  To test the clinical effect of FMT in patients with IBS        -  To describe the fecal microbiome in IBS patients        -  To describe changes in the fecal microbiome of IBS patients following FMT      The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on     IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients     will recruited from general practice and allocated to active (30) or placebo (30) by block     randomization. Donors will be 15 healthy volunteers with no risk behaviour and a     pre-screening for communicable diseases will be performed.      Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0,     1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing     (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.   "
86422|NCT02154854|"     The purpose of this study is to compare parallel-group effects between 4 months and 12 months     post-transplantation 2 values of target residual concentrations of Advagraf on vascular     parameters in de novo renal transplant patients.   "
86434|NCT02154698|"     The purpose of this study is to compare the usefulness of two needles (used for obtaining a     lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial     ultrasound   "
86423|NCT02154841|"     It is well known that patients who have undergone major surgical procedures are vulnerable to     the consequences of inadequate calorie or nutritional intake. Clinical studies have     demonstrated that early post-operative feeding increases strength and healing of an     intestinal anastomosis, reduces surgical site infection and length of hospital stay. The     'Enhanced recovery programme', ERP, includes early post-operative nutrition as one of its key     goals, however there is no guidance on the type of food that should be offered to patients in     this programme. Anecdotally, many patients and healthcare professionals believe that there     are differences in how food tastes to early post-operative patients. If there are changes in     taste following surgery this will affect the food choices that patients make in the early     post-operative period. No studies have addressed this question to date. In this study we hope     to describe this affect and consider the significance of any changes on the background of     current hospital food options.      We hypothesise that food preference and tastes and desires are altered in the early post     operative period and this affects what patients eat at this critical time.   "
86424|NCT02154828|"     The research project is part of the evaluation of the therapeutic approaches in mental     health. Its framework infant and juvenile units that have developed integrative devices,     taking into account recent advances in knowledge and providing care, education and     pedagogical approach. The evolution of autistic children receiving these integrative devices     is studied to determine the validity of the devices mentioned. The methodology is based on     case studies in a natural situation. Clinicians are committed to network among themselves and     with researchers in a multicenter study.   "
86425|NCT02154815|"     The main objective is to assess the psychological impact of pre-emptive kidney     transplantation on patients' quality of life taking into account psychological adjustment     (response shift), compared to patients who have experienced a short pre-transplant dialysis     period of less than 36 months.   "
86426|NCT02154802|"     Because people with undiagnosed HIV will not receive treatment and may unknowingly infect     others, the investigators propose a mobile computer-based video intervention to increase HIV     test rates in high volume urban hospital emergency departments (EDs). EDs offer important     points of contact for many of those at greatest risk for HIV. Unfortunately, when ED patients     are offered routine HIV testing, most decline. Our proposed intervention builds upon initial     findings from a trial our research team conducted with patients who declined HIV testing. The     intervention, grounded in the Information-Motivation and Behavioral Skills model (IMB),     showed an onscreen physician explaining the importance of HIV testing (to build knowledge and     motivation) and modeling a rapid HIV test (to increase motivation and behavioral skill). This     brief intervention had a potent effect: a third accepted HIV testing post-intervention. While     this preliminary study is highly encouraging, it revealed a number of other critical research     questions. First, it remains unclear what intervention component most strongly contributed to     patients' decisions to test: the video content or the offer of an HIV test by a computer     rather than a person. Second, consistent with the literature, participants indicated a     community member disclosing positive HIV status onscreen would increase the proportion of     patients who test. Third, results suggest there is individual variation in the extent to     which behavior is more strongly influenced by onscreen community members or experts (e.g.     physicians). Therefore, the goal of the present study, guided by the IMB model, is to     determine how the investigators can refine mobile computer-based interventions to maximize     HIV testing rates among patients who initially decline to test in the ED. At the end of the     computerized intervention, onscreen text will ask patients if they would agree to an HIV     test. Those who agree will be tested by ED staff. The study's endpoint will be     post-intervention HIV test rates. The investigators' study will inform scalable interventions     for underserved populations nationwide.   "
86427|NCT02154789|"     Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint,     usually the last joint of the finger or toe, often due to underlying joint arthritis. They     may connect with the joint. Pressure from the cyst can result in deformity of the digit's     nail and trauma to the cyst results in leakage of the fluid, representing a potential source     of entry for infection. Cysts can be tender and interfere with the digit's function. A     variety of treatments are available, from simple extrusion which is rarely successful, to     more destructive cryotherapy, infra-red coagulation and formal excision under local     anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant     injection of polidocanol in one small non-randomised trial has been reported to be a well     tolerated efficacious treatment with minimal scarring and long-term resolution. Following a     pilot study, the investigators aim to trial this treatment to assess efficacy in a larger     population.   "
86428|NCT02154776|"     This is a multi-center, open-label, non-randomized, phase I study   "
86430|NCT02154750|"     This is a randomized, prospective clinical trial to determine the effects of two different     pacemaker atrioventricular delay (AV delay) settings on heart function in patients with dual     chamber pacemakers implanted for symptomatic bradycardia with long PR intervals (delayed     conduction between upper and lower chambers of the heart). The study will compare a long,     fixed AV delay (standard) with an optimized AV delay for each individual using     echocardiography (experimental).   "
86431|NCT02154737|"     The purpose of this study is to see whether an altered schedule of giving erlotinib in     combination with gemcitabine will be safe and might improve the results of the treatment for     advanced cancer of the pancreas.      Gemcitabine and erlotinib are commercially available. Gemcitabine is FDA approved as     first-line treatment for patients with locally advanced, unresectable or metastatic cancer of     the pancreas. Erlotinib is FDA approved in combination with gemcitabine for the first-line     treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.      The FDA recommended dose for erlotinib is 100 mg daily. This study will investigate the     experimental administration of higher doses of erlotinib given for only three days twice a     month, a schedule called pulse dosing.   "
86432|NCT02154724|"     Despite its therapeutic effectiveness in Parkinson's disease (PD) the current deep brain     stimulation (DBS) strategy could achieve an even better clinical result by adapting to     patient's condition. As intracerebral activity analyzed by recording local field potentials     (LFPs) from DBS electrodes correlates to PD symptoms, a new stimulation approach would be an     intelligent adaptive DBS system able to change stimulation settings automatically to the     patient's needs using LFPs as control variable.   "
86433|NCT02154711|"     The purpose of the study is to use a new research imaging technique, a kind of magnetic     resonance imaging (MRI), to measure important metabolic features of muscle, including     mitochondrial function, in people with mitochondrial disease and in healthy individuals.     (Mitochondria are tiny organelles that generate energy for the body.)      It is hoped that this new strategy will help physicians to understand better the health     problems of people with mitochondrial disease. Eventually, this could lead to better     diagnostic and treatment approaches.   "
86435|NCT02154685|"     Smoking occurs in approximately 21% of the US population, is responsible for an annual     mortality rate of approximately 438,000 citizens, and has an associated healthcare economic     burden of $167 billion. Although pharmacotherapies have improved cessation outcome, the vast     majority of individuals making quit attempts relapse within 5-10 days of cessation. The     hypotheses to be examined in this study may have potentially important implications for     smoking cessation treatment and will, therefore, target the single greatest addiction-related     cause of morbidity and mortality.This study will investigate a novel behavioral strategy for     altering important memory processes that underlie human smoking-related nicotine addiction.     This strategy used in this study employs established cue exposure procedures to putatively     update smoking-related memory with information that will suppress responding to smoking cues.     The goal here is to alter existing nicotine-related memory directly rather than rely     exclusively on the establishment of an inhibitory extinction process, via traditional cue     exposure therapy, which is known to be vulnerable to spontaneous recovery, renewal and     reinstatement. Positive findings would represent a significant advance in exposure-based     therapy for addiction and could lead to a treatment that uniquely targets the problem of     cue-elicited craving and reactivity, thereby addressing a major obstacle to successful     smoking cessation.   "
86436|NCT02154672|"     The purpose of this study is to determine the incidence of prostate cancer in men with the     BRCa2 gene mutation as an independent indicator for prostate cancer screening.   "
86437|NCT02154659|"     Gastroesophageal reflux disease is increasing worldwide. The causes of reflux symptoms are     not found exactly. especially, the postprandial reflux symptoms are more common than the all     day reflux symptoms. One of the causes of reflux symptoms is the relaxation of the lower     sphincter of the esophagus. But, the sphincter relaxation also occur in normal people. But,     there is a difference in postprandial reflux pattens between the patients and the normal     people. So, in this study, we want to compare the difference of reflux pattern between the     patients who have postprandial reflux symptoms and normal people though the 24hr pH     monitoring.   "
86438|NCT02154646|"     The main purpose of this study is to evaluate the safety and side effects of LY2157299 in     combination with gemcitabine in Japanese participants with pancreatic cancer that is advanced     or has spread to another part of the body.   "
86439|NCT02154633|"     Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer     syndrome. Genetic testing identifies mutation carriers and enables them to manage their     cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance).     However, uptake of genetic testing among at-risk individuals is low, implying that     information about the disease and genetic testing is not being communicated effectively among     family members. Mutation carriers are distressed about disclosing test results, while their     relatives do not understand the implications of a positive test result for their own health.     Thus, interventions that support family communication about genetic risk, and address     psychological distress of family members could contribute to more effective management of     hereditary breast/ovarian cancer.      The project aims to develop a family communication and decision-support intervention to 1)     increase family communication about BRCA1/2 mutations; 2) reduce psychological distress     associated with these mutations; and 3) increase informed decision-making regarding uptake of     BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk     relatives will inform the refinement of the intervention, as well as timing and mode of     delivery. Two group, pre-post test study with a new sample of mutation carriers and family     members will be used to test the feasibility, acceptability, and effect of the intervention.   "
86440|NCT02154620|"     Distal radius fractures with dorsal dislocation among patients 70 years or older are     randomized to conservative treatment with plaster or internal fixation with a volar plate.     Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray,     functional scores and clinical examination.   "
86441|NCT02154607|"     Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally     presenting a management challenge to the clinician. In addition it can have debilitating     consequences on the patients' quality of life. The malignant transformation of OLP has been     well documented. The aims of this work were to measure the number of patients developing     malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients undergoing     traditional symptomatic treatments with those patients that were treated by CO2 laser from     2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).   "
86442|NCT02154594|"     To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in     patients with fixed orthodontic appliances.This study is a double blind randomized controlled     trial.   "
86443|NCT02154581|"     In this study a tooth that needs to be extracted will be replaced by an implant (artificial     root) placed at the same appointment as the extraction. The investigators want to observe how     the gums change shape with healing in two different scenarios:        1. If the soft tissue around your tooth is thin, following extraction and implant placement          an extra soft tissue graft (taken from your palate) in the area in order to increase the          thickness of your gums after healing.        2. If the soft tissue around your tooth is thick, the implant will be placed without a soft          tissue graft.      Previous studies have shown that both methods work and can give good results. In fact the two     methods are used routinely but they have never been compared objectively to one another in     the same research study.      The main purpose of this study is to evaluate if there is any difference in terms of esthetic     outcomes between these two treatment modalities after a crown has been placed on the implant.   "
86444|NCT02154568|"     Computer simulations are being developed to predict air flow abnormalities in the airways of     patients with lung disease. The purpose of this study is to obtain actual gas flow     measurements in the lungs of healthy patients and patients with lung disease and use these     measurements to validate the computer models.   "
86457|NCT02154399|"     This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen,     hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in     measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.   "
86557|NCT02153086|"     The purpose of this survey is to examine the safety and efficacy of long-term use of     ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep     associated with insomnia in daily medical practice.   "
86445|NCT02154555|"     Chronic rhinosinusitis (CRS) is a common sinus and nasal condition affecting more than 33     million Americans. The treatment of CRS typically begins with maximal medical therapy     however, when this fails to improve patient symptoms, surgical intervention is considered.     Endoscopic sinus surgery (ESS) is a well-established treatment for refractory CRS with     approximately 600,000 sinus surgeries performed annually in the United States alone. Despite     the success of this intervention, up to 26% of patients experience complications following     surgery, including middle meatal (MM) synechiae, edema, polyp recurrence, and middle     turbinate lateralization. Currently, there is no consensus as to the postoperative care     regime that is most effective at minimizing or preventing these potential complications.     Therefore there is need for further study into the role of debridement, examining patients     undergoing endoscopic sinus surgery while concurrently addressing the potential confounders     of maximal medical therapies in the postoperative setting.      This prospective, randomized, single-blind, controlled study design will investigate the     efficacy of postoperative debridement following ESS. Patients who have undergone ESS will     have one nare randomized to debridement and the other to no debridement at the first week     post-operative visit. In this way, the patients will act as their own controls in order to     account for inter-patient variability in disease severity. The primary outcome will assess     synechiae formation attributed to ESS. Secondary outcomes will include pain (side-specific)     attributed to the debridement procedure as well as comparing pre and post endoscopy scores     and SNOT-22 questionnaire responses.   "
86446|NCT02154542|"     Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive     care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial     pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the     duration of ventilation, mortality, length of ICU stay and health costs. The practitioner     should ask the benefit of the continuation of this IV daily and adapting it, to limit     complications. The evaluation of the work of breathing is a key element in understanding the     pathophysiology of respiratory distress but is also a key element in improving the management     of ventilatory support and the adjustment of ventilatory parameters .      It has been shown that there is an increased work of breathing in all children admitted in     ICU for clinical acute respiratory distress that is significantly reduced by ventilatory     support. There is probably a relationship that should be proportional between the work of     breathing ( PTP ) resulting in respiratory request triggered by the respiratory drive and the     electrical activity of the diaphragm ( Edi ) .      The validation of this correlation PTP / Edi has a direct impact on the monitoring of     ventilated patients with the ability to monitor the physiological factor while maintaining a     classical treatment of children by simply monitoring Edi without additional invasive device .   "
86447|NCT02154529|"     Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the     combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast     cancer   "
86449|NCT02154503|"     Androgenetic Alopecia is the most common non scarring alopecia worldwide. Treatment of which     has been limited with few options for medical and surgical treatment, the cost of the latter     being prohibitive for many. Recently there have been several new modalities proposed as     treatment, namely Microneedling and Platelet Rich Plasma.      Microneedling has been shown to overexpress hair growth factors which may enhance or     stimulate miniaturized hairs to grow. It has also been shown to increase the absorption of     topical products significantly. The exact mechanism of action of Microneedling is still being     delineated.      In this study, we aim to do a half lesional study with global photographs and hair counts     done at the start of , week four and week twelve. Patients would be needled once weekly after     application of topical anaesthetic (5% EMLA). If by week six there is significant regrowth     (>30%), then total lesional needling will be done. Patients will only be using topical 5%     Minoxidil throughout the study as this will prolong the effects of the regrowth.   "
87610|NCT02139306|"     This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,     efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis     (nmCF) not receiving chronic inhaled aminoglycosides.   "
86450|NCT02154490|"     This screening and multi-sub-study randomized phase II/III trial will establish a method for     genomic screening of similar large cancer populations followed by assigning and accruing     simultaneously to a multi-sub-study hybrid Master Protocol (S1400). The type of cancer     trait (biomarker) will determine to which sub-study, within this protocol, a participant will     be assigned to compare new targeted cancer therapy, designed to block the growth and spread     of cancer, or combinations to standard of care therapy with the ultimate goal of being able     to approve new targeted therapies in this setting. In addition, the protocol includes a     non-match sub-study which will include all screened patients not eligible for any of the     biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of     care also with the goal of approval.   "
86451|NCT02154477|"     Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a     condition called hypogonadotrophic hypogonadism (HH). People with this condition produce     little or no sex hormones. Obesity and metabolic syndrome are also associated with HH.     Research suggests that insulin in the brain may benefit the glands that release these     hormones. During this study, subjects will spray a small amount of insulin into their     nose.This will increase insulin concentrations in the brain. The purpose of this study is to     find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in     obese diabetic men with HH.   "
86452|NCT02154464|"     The investigators predict that giving patients paracetamol in the operative period will     reduce their need for opioid pain reducers in the post operative setting.   "
86453|NCT02154451|"     The hypothesis or study goal is to determine whether functional dynamic infrared imaging can     be used for melanoma and other skin cancer screening and/or diagnosis.   "
86454|NCT02154438|"     The purpose of this study is to evaluate the effect of ketamine infusion for reduction of     neuropathic pain and improvement of quality of life after lumbar surgery.   "
86456|NCT02154412|"     This clinical study is designed to investigate the mechanisms of blood pressure regulation     and respiratory motor function affected by spinal cord injury (SCI). We hypothesize that     impaired blood pressure regulation in individuals with chronic SCI can be improved by     restoring respiratory motor function by using Respiratory Motor Training (RMT).   "
86458|NCT02154386|"     Bone grafting following tooth extraction is commonly performed to preserve bony ridge     dimensions adequate to support subsequent implant placement. Alveolar ridge resorption     commonly occurs following tooth extraction, and the decrease in bone volume has the potential     to make dental implant therapy impossible without surgery to reconstruct the ridge. The aim     of ridge preservation grafting is to prevent or minimize this resorptive process, thereby     preserving an adequate volume of bone for implant placement. Ridge preservation generally     involves placement of a particulate bone graft material in the tooth socket, followed by use     of a membrane or similar substance over the socket entrance to contain the bone graft.     Various grafting materials have been recommended for these ridge preservation procedures,     including demineralized freeze-dried bone allograft (DFDBA). The timing of dental implant     placement following ridge preservation procedures is controversial, and few studies have     examined the effects of different healing time intervals between ridge preservation and     implant placement. The purpose of this project is to evaluate the formation of new bone at a     site where tooth extraction has been performed followed by grafting using DFDBA. Two     different study groups are included, one having the dental implant placed 8-10 weeks after     tooth extraction and ridge grafting, the other having the dental implant placed 18-20 weeks     after extraction and grafting.   "
86459|NCT02154360|"     This is an open-label, single arm, phase I study to determine the safety, PK characteristics     and anti-inflammatory effects of the NK-R1 coadministered with ritonavir-containing     antiretroviral therapy in individuals with well-controlled viral replication.      Our hypothesis is that Aprepitant will be safe, well tolerated, and will have     anti-inflammatory properties when administered concomitantly with the protease inhibitor     ritonavir.   "
86460|NCT02154347|"     The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as     combination therapy with insulin in patients with type 2 Diabetes Mellitus who show     inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral     hypoglycemic agent.   "
86461|NCT02154334|"     The purpose of this study is to evaluate the effects of allergic rhinitis (group of symptoms     affecting the nose) and co-administration of mometasone or oxymetazoline on the     pharmacokinetics (explores what the body does to the drug), safety, and tolerability of     intranasal (administered through the nose) esketamine.   "
86462|NCT02154321|"     The purpose of this research is to assess and determine brain oscillations or brain     signatures of adult participants with Attention Deficit Hyperactivity Disorder (ADHD)     relative to adult participants without ADHD using the technique electroencephalogram (EEG).     Electroencephalogram is entirely non-invasive way of tracking brain activity.The main goal of     this study is to establish biological factors for determining the diagnosis of Attention     Deficit Hyperactivity Disorder (ADHD).   "
86463|NCT02154308|"     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated     Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single     intramuscular injection.   "
86464|NCT02154295|"     The purpose of this study is to investigate and compare the images obtained from coronary     imaging catheters used in the treatment of coronary blockages both in a clinical setting with     patients and in models.   "
86465|NCT02154282|"     To see if using ipod games can improve mental functioning   "
86466|NCT02154269|"     The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in     patients with chronic heart failure secondary to Chagas disease.   "
86467|NCT02154256|"     This study will be a three-arm randomized, controlled trial that the investigators will run     in 2014 with approximately 4,000 users of an app called Achievemint. AchieveMint rewards     users with points (which can be redeemed for prizes) for every step they take. The     investigators will be testing three different point-based programs designed to encourage     users to build exercise habits over the course of a month: stable incentives, increasing     incentives, and decreasing incentives. After the investigators' month-long intervention     period, the investigators will observe users' step counts during a month-long follow-up     period to test which of the investigators' habit-building programs leaves users with the best     exercise habits (or the highest step counts) after they conclude.      The time frame of observation will be 8 months.   "
86468|NCT02154243|"     Orthostatic hypotension following total hip arthroplasty is known to limit the ability of     patients to perform physical therapy (PT) and increase the length of hospital stay and costs.     Our goal is to prospectively study the effects of oral midodrine on the signs and symptoms of     orthostatic hypotension in 20 patients and the effects of intravenous fluid on the signs of     symptoms of orthostatic hypotension in 10 patients. Midodrine will be administered to     patients with suspected low SVV, and an intravenous fluid bolus will be administered to     patients with low CO. 120 patients will be consented with a view to studying 30 patients who     meet the inclusion criteria for orthostatic hypotension. Patients who receive midodrine or     the fluid bolus will undergo hemodynamic measurements at 30 min, 1 hr, 2 hrs, 3 hrs, and 4     hrs post-intervention. All patients will undergo measurements for blood pressure, arterial     augmentation index, and heart rate at baseline (pre-op; holding area) and the time of first     PT attempt. Patients will be monitored up to post-operative day 3. The working hypothesis is     that midodrine or fluid therapy will significantly raise the mean arterial blood pressure     (MAP) by 5 mmHg+ and/or cause a significant change in the Orthostatic Hypotension     Questionnaire (characterized by a two-point improvement in symptom score).   "
86469|NCT02154230|"     Overweight and obese patients will be recruited and randomly assigned to two groups of     intervention. To the first group [sulphate-bicarbonate-calcium water and low-calorie diet     (SW-D)] will be administered Acqua Santa di Chianciano®, associated to a personalized low     calorie diet, while the second group [tap water and low-calorie diet (TW-D)] will follow the     personalized low calorie diet but will be asked to drink the same quantity of tap water, over     a 4 week period. Stool samples will be collected and analyzed for changes in gut microbiota     composition. Patients' body weight will be recorded at the beginning and at the end of the     study.   "
86470|NCT02154217|"     This is a data revision with a focus on 24 hour perfusion pressures of data from a previous     randomized, double masked, multicenter clinical trial.      The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and     timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a     nonfixed combination of latanoprost and timolol.      The main findings of the original trial had been published on Ophthalmology [2007;114:     2244-2251].   "
86471|NCT02154204|"     The aim of this study is to examine the use of Near Infrared Fluorescence imaging on     lymphatic vessels in humans.      Different parameters that reflect lymphatic function will be tested for intra and inter     individual reproducibility.      We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy     men between the ages of 20 and 30.      When the fluorescent dye indocyanine green, has been injected into the skin on the patients     feet, it will be transported through the lymph vessels, resulting in clear visualization of     the vessels, using a laser and a EM-CCD camera.      On both legs we examine the frequency of vessel contraction and the velocity of lymph moving     in vessels. We furthermore use several methods to quantify the vessel function such as the     refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and     pumping pressure (at what pressure lymph can pass a blood pressure cuff).      We investigate the activity of vessels over time, and after several interventions such as     exercise, and water baths of the foot at different temperatures.      The patients are examined for approximately 4 hours and wil be examined again 14 days later.   "
86472|NCT02154191|"     The purpose of the proposed research is to explore the relationship between objectively     measured physical activity and surgical intervention for lumbar spinal stenosis (LSS). Our     primary hypothesis is that post-surgery, LSS patients will demonstrate increased physical     activity compared to their baseline assessment. A non-intervention control group will be     measured at the same time intervals as the surgical group to look at test re-test     reliability. In the event that our hypothesis is rejected, and surgery does not lead to a     decrease in sedentary behaviour analysis of questionnaire-based sedentary behaviour measures     and objective activity-based measurement can examine the relationship between self-report and     actual performance-based objective measures. The primary objective of our proposal is to     determine if surgical intervention leads to increased activity, and decreased sedentary     behaviour. The findings of the proposed research will inform healthcare stakeholders that if     surgery alone does not lead to increased activity, a more concerted research effort may need     to be made for post-surgical rehabilitation, lifestyle and physical activity counselling so     that post-surgical patients may make changes toward leading more active and productive lives.   "
86473|NCT02154178|"     The investigators hypothesized that the use of biomarkers of invasive fungal infections would     increase the percentage of early discontinuation of empirical antifungal therapy and thus     reduce the duration of treatment in ICU patients.   "
86474|NCT02154165|"     The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by     clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength     about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden     standard in phototherapy treatment today. Though, previous studies used light tubes, today we     use light emitting diodes (LED'S).      The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus     blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33 weeks     and uncomplicated hyperbilirubinemia.   "
86475|NCT02154152|"     Homeopathic Medicine Causticum 200c will be prescribed in cases of Primary Enuresis on the     basis of available symptoms for a period of one year and the results will be evaluated at the     end of the given period and efficacy of the drug will be assessed.   "
87648|NCT02138812|"     Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II     dose (RP2D) of BAY1161909 in combination with paclitaxel in subjects with advanced     malignancies.   "
86476|NCT02154139|"     The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks)     of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25     mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well     as to examine factors that can influence the safety and efficacy of treatment with     leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).   "
86477|NCT02154126|"     The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics     Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with     reference standard measurements (YSI glucose analyzer). The investigation will also evaluate     safety of the Senseonics CGM System usage, while in the clinic and during home use.   "
86478|NCT02154113|"     The purpose of this study is to compare the clinical performance of the Ultrashape system     with VelaShape II device for reduction of the waist.   "
86479|NCT02154100|"     The hypothesis of this study is that the daily consumption of 480 ml tart cherry juice for     twelve weeks will improve blood pressure and arterial stiffness by improving     endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering     biochemical markers associated with cardiovascular risk. 28 men and women between the ages of     20 and 40 who have three of the five features of metabolic syndrome as defined by the Adult     Treatment Panel III will be included in the study. After a two-week run-in phase, eligible     men and women will be randomly assigned to one of two treatment groups: 1) 480 ml tart cherry     juice or 2) 480 ml control drink daily for twelve weeks. After an initial telephone     screening, all participants will be requested to report to the study site for their first     visit. On the first visit (screening), participants will be provided with verbal and written     explanation of the project. They will then be asked to sign an informed consent form,     followed by measuring waist circumference, resting brachial blood pressure, fasting serum     triglycerides, high density lipoprotein cholesterol, and glucose levels to confirm metabolic     syndrome. Baseline assessments will be performed for medical history, medication use, dietary     intake, and physical activity. Qualified participants will be scheduled for their second     visit two weeks later (actual baseline data collection) and randomly assigned to their     treatment group. On the second (baseline) visit between the hours of 7-10 A.M., blood     pressure and vascular function will be measured followed by blood draw. Anthropometrics will     be measured. Participants will be provided with their assigned treatment and will receive     standard instructions on how to fill out daily diaries for their treatment, and for food and     physical activity records. Blood pressure, vascular function, blood draw, and anthropometric,     body composition, diet, and physical activity assessments will be repeated at 6- (third     visit), and 12-week (final visit) intervals. All cardiovascular measurements will be     performed between 7:00 to 10:00 A.M., in a quiet temperature-controlled room in the supine     position after an overnight fast and 12 hours after the abstinence of caffeine and/or 24     hours after the last bout of moderate to heavy physical activity.   "
86480|NCT02154087|"     Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in     chronic venous leg ulcers   "
86481|NCT02154074|"     Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the     activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the     operation period. Dexmedetomidine have influence on perioperative stress response and immune     function,but it is not clear.   "
86502|NCT02153801|"     The aim of this study is to compare the incidence of genito-urinary function depression and     anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal     Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left     Colic Artery by a prospective randomized trial.   "
86482|NCT02154061|"     The purpose of the study is to better understand how the use of antibiotics changes     micro-organisms in the intestines. The change to micro-organisms in the intestines may change     the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu)     vaccine.      In particular, the investigators will be looking at certain markers in blood after     vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before     vaccination.      There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days     prior to vaccination and continue taking antibiotics the day of vaccination and one day after     vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine)     and will not take any antibiotics.      The investigators hope to enroll 50 subjects at Emory.   "
86483|NCT02154048|"     The purpose of this study is to determine whether the addition of dexamethasone prolongs     analgesia when added to long-acting local anesthetic during single-injection supraclavicular     block for outpatient hand surgery.   "
86484|NCT02154035|"     Background:      Human Immunodeficiency Virus (HIV) is the virus that causes AIDS. HIV can hide in the blood     for many years, even in people who have their HIV infection under control. HIV that is hiding     in the blood is called the latent HIV reservoir. Researchers want to find out more about it     in this study. This knowledge may help them develop new ways to prevent or control HIV. This     study will draw its participants from the Rakai Health Sciences Program in rural southwestern     Uganda.      Objective:      - To measure and learn about the latent HIV reservoir in Ugandans with HIV.      Eligibility:      - Men and women at least 18 years of age with HIV.      Design:        -  Participants will have a medical history and physical exam. Their medical records will          be reviewed. Researchers will ask participants about their health and recent illnesses.          Participants able to get pregnant will have their urine tested for pregnancy.        -  Participants will have their finger pricked to see if they have enough red blood cells          to be eligible for the study.        -  If eligible, participants will have blood drawn through a needle in the arm. Their blood          will also be tested for other diseases.        -  After the blood draw, participants will be asked to stay seated or lying down if they          are not feeling well for up to 30 minutes.   "
86485|NCT02154022|"     Background:      - Certain drugs even when they are meant to help people cause side effects. These are     unwanted effects of the drug. There are many reasons why a drug might cause side effects in     one person and not in another. It may be because of how much of the drug is in the person s     blood at one time. Researchers want to study the blood of people having drug side effects to     better understand why they happen.      Objective:      - To obtain blood samples from patients being treated with an investigational or FDA approved     drug at the National Cancer Institute who are having bad side effects that are thought to be     due to large amount of the drug in their blood. The samples will be used to assess the cause     of the side effects.      Eligibility:      - People 2 years and older with cancer who are currently enrolled in clinical trials at the     National Cancer Institute.      Design:      - Participants will give blood samples.   "
86497|NCT02153866|"     Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if     the safety and immunogenicity are same between inoculating several vaccines simultaneously     and inoculating individually. So we carry out this study.      The purpose of this study is to evaluate the difference of safety and immunogenicity on     vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or     measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR     individually.   "
87649|NCT02138799|"     This study evaluates how a drug that alters liver enzymes (rifampin) affects the metabolism     of enzalutamide in men by measuring concentrations of enzalutamide and its metabolites in     plasma.   "
86486|NCT02154009|"     Background:      - The autonomic nervous system helps control things that happen automatically in the body,     like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called     dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn     how to better diagnose them.      Objectives:        -  To allow people with autonomic disorders to be evaluated.        -  To help fellows in the NIH Autonomic Disorders fellowship program see a variety of          diseases in their training.      Eligibility:        -  People age 18 and older with dysautonomia; children over age 2 if they might benefit        -  Healthy adult volunteers      Design:        -  Participants will have different procedures depending on their symptoms. They will have          one or more visits. They will have some but not all of the tests below.        -  Participants will have a medical history and physical exam. They may be tested for          problems thinking. They may complete a symptom questionnaire. They may have their          temperature and blood pressure taken.        -  Participants may have an intravenous line placed. A needle will guide a thin plastic          tube into an arm vein.        -  Participants may have blood drawn several times. They may give a urine sample.        -  Participants may have an electrocardiogram.        -  How much blood a participant s heart is pumping and/or how much blood is flowing through          their arm may be measured. The total amount of blood in their bloodstream may be          measured.        -  Participants may have their ability to sweat and/or sense of smell tested.        -  Breathing, bowel sounds, and/or body functions may be monitored.        -  Pupil size, response to environmental temperature changes, and/or breathing may be          measured.        -  Participants may have a bladder ultrasound.        -  Small pieces of skin may be taken for study.   "
86487|NCT02153996|"     Plasmodium falciparum malaria is a major cause of morbidity and mortality in tropical and     sub-tropical areas worldwide. Repeated P. falciparum infections in endemic areas induce     protective immunity, thus providing optimism that an effective malaria vaccine can be     developed. Key to the development of such a vaccine is an understanding of the immune     mechanisms underlying protection and the longevity of these responses in the absence of     continuous P. falciparum exposure. Anecdotal evidence suggests clinical immunity to malaria     wanes within months to years after an immune individual leaves an endemic area. A detailed,     systematic description of the quality and longevity of the P. falciparum-specific humoral and     cellular immune responses in such individuals over time in the absence of ongoing exposure is     lacking.      This protocol will attempt to fill this knowledge gap through comprehensive longitudinal     immunological analyses of two populations of healthy adult volunteers: 1) naive travelers     returning from malaria endemic areas recently treated (within 2 weeks) for acute P.     falciparum malaria and referred from hospitals in the metropolitan Washington DC area; and 2)     immigrants from malaria endemic areas living in the metropolitan Washington DC area with     serologic evidence of past P. falciparum exposure. In both groups, venipuncture and possibly     apheresis will be performed for the isolation of plasma, RNA and peripheral blood mononuclear     cells (PBMCs) which will be analysed to understand the components of innate and adaptive     immunity to malaria. Na(SqrRoot) ve travelers returning from malaria endemic areas recently     treated for acute malaria will undergo venipuncture at enrollment, then once every 2 weeks     for 2 months, then every 3 months for 1 year, and then every 6 months for up to 5 years.     Immigrants will be seen every three months for one year and then every six months for up to 5     years. All subjects who return to the U.S. from a malaria endemic area will be evaluated     within two weeks of return for repeat venipuncture and will restart the same sequence of     blood draws as naive travelers. Optional apheresis will be performed on both na(SqrRoot) ve     travelers and immigrants at enrollment, at 1, 6, and 12 months, then yearly therafter.      The primary objective is to estimate the quality and longevity of P. falciparum-specific     humoral and cellular immune responses in the absence of ongoing P. falciparum exposure in     both returned na(SqrRoot) ve travelers and immigrants. The secondary objective is to compare     the P. falciparum-specific humoral and cellular immune response in na(SqrRoot) ve travelers     and immigrants to individuals in malaria-endemic areas enrolled in ongoing LIG protocols in     Mali.   "
86558|NCT02153073|"     The purpose of this study is to evaluate the safety and efficacy of long-term use of granular     capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in     patients with hyperlipidemia in daily medical practice   "
86488|NCT02153983|"     Background:      - Being overweight may cause low-level inflammation. This inflammation may cause some of the     medical problems of obesity, like high blood sugar (diabetes) and heart disease. This study     will test whether a medication called colchicine can improve metabolism in adults who are     overweight but have not yet developed diabetes.      Objectives:      - To learn whether colchicine improves sugar regulation and metabolism.      Eligibility:      - Healthy overweight adults18 to 100 years old.      Design:        -  Participants must fast before each visit, including the screening visit.        -  Participants will be screened with blood tests,urine tests, medical history, and          physical exam. They will have to drink sugar water, and have blood drawn to find out if          they are healthy.        -  For visit 1, participants will have a medical history and physical exam and answer          questions. They will have blood taken with an intravenous (IV) line, give urine sample,          and give 2 stool samples..        -  Also, subjects will get sugar water through one IV. Blood will be drawn from the other.          This measures sugar and insulin levels. During this, participants will lie in a bed and          can watch TV.        -  Participants will have a full-body X-ray, lying on a table while a camera passes over          them. They will also have an abdominal CT scan, lying on a table that moves through a          ring that takes pictures.        -  Participants will have a small fat tissue sample taken from their abdomen. It is like          getting a mini-liposuction.        -  Participants will be given the study drug or placebo. They will take it twice daily for          3 months.        -  For visit 2, participants will have blood tests, urine tests, medical history, and          physical exam.        -  For visit 3, participants will repeat the tests in visit 1.   "
86489|NCT02153970|"     Background:      - Neuromuscular diseases (NMDs) do not have cures. But future treatments will try to improve     the health-related quality of life (HRQoL) in people with NMD. Computer questionnaires can     help test HRQoL in people with NMD. They could help clinicians and researchers know how     people with NMD and their caregivers are doing. They could also help show if treatments are     making a difference.      Researchers want to make sure two of these questionnaires PROMIS (Patient Reported Outcomes     Measurement Information System) and Neuro-QOL (Quality of Life in Neurological Disorders)     work the same way every time. They also want to make sure the questionnaires test the same     things every time.      Objective:      - To make sure the PROMIS and Neuro-QOL questionnaires are valid.      Eligibility:      - Children age 8 17 who have NMD. Also, caregivers of children age 5 17 who have NMD.      Design:        -  Participants will complete the PROMIS and Neuro-QOL questionnaires on a computer. The          caregiver and child versions are not the same.        -  Participants will complete the questionnaires at the beginning of the study. It will          take about 15 20 minutes. They will complete the questionnaires again after 2 4 weeks.          They may receive phone or email reminders.        -  Participants will complete the questionnaires at the NIH outpatient clinic and/or on          their own device. At NIH, they will use a computer or tablet.   "
86490|NCT02153957|"     Background:      - More children with cancer are surviving into adulthood. Some side effects from treatment go     away quickly. But some problems may not go away or may only show up months or years later.     These problems are called late effects. Late effects can cause difficulties in cognitive     functions, such as attention and memory. Physical activity has been found to improve the     attention and memory skills of children with Attention Deficit Hyperactivity Disorder (ADHD).     Researchers want to see if physical activity can help with these cognitive problems in     children with brain tumors.      Objectives:      - To see if physical activity can improve cognitive functions in children who had radiation     therapy for a brain tumor.      Eligibility:      - Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must have     access to a computer.      Design:        -  Participants will be screened with height, weight, and medical history. They will answer          questions about daily physical activities. Their heart will be checked.        -  Participants will go to the clinic for 2 days. They will have a fitness exam and tests          about attention, memory, and concentration. They will have blood taken and answer          questions. Parents will also answer questions.        -  Participants will be put into 2 groups. For the first 12 weeks, the intervention group          will follow a physical activity program. The control group will do their usual physical          activities.        -  For the second 12 weeks, the control group will follow the physical activity program.          The intervention group will continue the activities on their own. All groups will track          their physical activity with an activity monitor and computer.        -  Participants will have a follow-up visit at the clinic after each session. They will          repeat some of the tests listed above.        -  The study lasts 24 weeks plus the two follow-up visits. Participants can keep their          activity monitor.   "
86498|NCT02153853|"     Obesity is on the rise in the Western population and BMI has been shown to be associated with     an increased risk of per- and postoperative complications.      The investigators intend to study a population of more than 300 patients undergoing     laparoscopic surgery for rectal cancer.      The investigators main outcome measure will be the conversion rate, and the investigators     also intend to study other indications of short term complications, such as peroperative     bleeding, infection, re-operation and mortality.      The investigators hypothesise that increased BMI does not increase the risk of conversion.   "
86499|NCT02153840|"     The purpose of this study is to evaluate the efficacy and safety of Chinese herbal     PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of     Chinese Medicine.   "
86491|NCT02153944|"     Background:      Stress and anxiety can interfere with how well people perform tasks. But performing a task     can sometimes lessen anxiety by distracting people from the stress. Researchers want to     examine the interaction between attention and stress. They will use two drugs with different     effects on stress and concentration.      Objective:      - To better understand how thinking and emotion affect anxiety and performance. Also, to     study the effects of methylphenidate and propranolol on performance.      Eligibility:      - Adults age 18 50.      Design:        -  First, participants will be screened with a test in which they hear loud, sudden noises          through headphones. Sticky pad electrodes will be placed on the skin under one eye.          These electrodes will tell us how sensitive participants are to the noises.        -  Second, participants will complete questionnaires about their mood, thinking, and          anxiety. They will give a saliva sample. For this, a cotton swab will be placed in their          mouth for 2 minutes.        -  Third, participants will take a single dose of one of the study pills or a placebo. They          will then look at words, shapes, and letters on a computer monitor. They will answer          questions about what they remember. They may receive a shock or hear loud noises during          the tests.        -  For the shocks, small metal disk or sticky pad electrodes will be taped to a wrist or          finger. For recording bodily responses, additional electrodes will be placed on the          arms, body, and under each eye.        -  Blood pressure and pulse will be measured during the tests. More saliva samples will be          taken.        -  At the end of the study, participants will answer questions about their reaction to the          study testing and about any effects they noticed from the study pill.        -  After the experiment, participants will be evaluated for effects of the study pill.   "
86503|NCT02153788|"     The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and     one of which is a placebo (an inactive substance that looks just like the temazepam), to see     if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are     given in research studies to try and make sure that subjects are responding to the effects of     the study drug and not to other factors, like the attention they are receiving. If you decide     to take part in this study, you will take 1 capsule of study drug every night approximately     30 minutes before bedtime for approximately 12 weeks.      This study is to test the study drug called temazepam for the treatment of insomnia (trouble     sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the     treatment of insomnia. However, because this study requires treatment for 12 weeks instead of     the 7 to 10 days approved by the FDA, the use of temazepam is considered to be     investigational in this study.   "
86504|NCT02153775|"     Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive     Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.   "
86559|NCT02153060|"     The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known     hospitals in China. In order to report the efficacy and safety of different dose     dexamethasone in treating the immune thrombocytopenia (ITP).   "
86492|NCT02153931|"     Background:      - Studies show that Internet Support Groups (ISGs) can help parents of children with chronic     conditions. Researchers want to find out if ISGs can help parents of a child with the genetic     disorder Neurofibromatosis Type 1 (NF1).      Objective:      - To see if an ISG for parents with a child with NF1 can give the parents more social support     and less anxiety.      Eligibility:      - Adults age 18 and older with a child (age 0 25 years) with NF1.      Design:        -  Participants will register for the study on a website hosted by the Children s Tumor          Foundation.        -  Participants will complete 5 questionnaires. These will be about their emotional          well-being, their child s health status, and their contact information.        -  The ISG will include a Discussion Forum that participants can enter 24 hours a day, 7          days a week. A professional moderator will post questions and discussion topics. The          moderator can also respond to questions. They will be a psychologist, a psychology          associate, or a nurse-practitioner. Each one will be highly experienced at working with          young people with NF1 and their families.        -  The ISG also will contain a chat room. Here participants can chat with other users in          real time. The chat room will be open for one 90-minute session per week.        -  The ISG will remain open for 8 weeks. Then participants will retake 4 of the          questionnaires from the beginning of the study. They will also complete 1 other          questionnaire about their experiences with the ISG. Information from any messages          participants post on the ISG website will be collected.        -  Three months after the ISG closes, participants will complete the questionnaires one          final time.   "
86493|NCT02153918|"     Background:      - Some men with prostate cancer have their prostate glands removed. The cancer can still come     back. Researchers want to know if receiving a vaccine before prostate removal surgery can     lead to less recurrence.      Objective:      - To see if a vaccine and booster shots given to men with prostate cancer before surgery     changes the immune cells in the prostate gland.      Eligibility:      - Men age 18 and older who have prostate cancer that has not spread, and who want to have     their prostate glands removed as treatment.      Design:        -  Participants will be screened by their regular cancer care. They may have a small piece          of prostate removed.        -  Participants must practice effective birth control before and during the study treatment          and for 1 month after the last vaccine booster.        -  Participants will have a medical history, physical exam, and blood and liver tests. They          will be asked about how they perform daily activities.        -  Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The          scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table          that slides in and out of the scanner.        -  Participants will be injected with the vaccine, most likely in the leg. They will be          injected with the vaccine booster 3 times over several weeks.        -  At each booster visit, participants will have a medical history, physical exam, and          blood and liver tests.        -  Participants will have another MRI. Then they will have surgery to remove their          prostate.        -  Participants will have 2 follow-up visits during the year after surgery. They will have          a medical history, physical exam, and blood test.   "
86494|NCT02153905|"     Background:      The NCI Surgery Branch has developed an experimental therapy for treating patients with     cancer that involves taking white blood cells from the patient, growing them in the     laboratory in large numbers, genetically modifying these specific cells with a type of virus     (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.     This type of therapy is called gene transfer. In this protocol, we are modifying the patient     s white blood cells with a retrovirus that has the gene for anti-MAGE-A3 incorporated in the     retrovirus.      Objective:      The purpose of this study is to determine a safe number of these cells to infuse and to see     if these particular tumor-fighting cells (anti-MAGE A3 cells) cause tumors to shrink and to     be certain the treatment is safe      Eligibility:      - Adults age 18-66 with cancer expressing the MAGE-A3 molecule.      Design:        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as          needed        -  Leukapheresis: If the patients meet all of the requirements for the study they will          undergo leukapheresis to obtain white blood cells to make the anti MAGE-A3 cells.          {Leukapheresis is a common procedure, which removes only the white blood cells from the          patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the anti MAGE-A3 cells and aldesleukin. They will          stay in the hospital for about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits take up to 2 days.   "
86495|NCT02153892|"     To assess the safety and performance of the GDS Accucinch System when used percutaneously to     reduce functional mitral regurgitation.   "
86496|NCT02153879|"     The structural and functional alterations of high density lipoproteins (HDL) levels in type 2     diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance,     inflammation and oxidation, play a major role in the increased macrovascular risk in these     patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL     concentrations.      Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by     ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship     between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of     arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in     Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the     impact of HDL increasing drugs on HDL qualitative changes.   "
86500|NCT02153827|"     The purpose of this study is to examine the effects of eccentric exercise to the shoulder     muscles for people with shoulder pain. Identifying specific exercise protocols for     individuals with shoulder pain will provide evidence to help clinicians select the best     interventions.   "
86501|NCT02153814|"     Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro     fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with sperm     to make embryos, which are then placed in the woman's uterus using a small catheter, a     procedure called embryo transfer. Unfortunately, pregnancy rates from IVF are less than     50%. Recently, several studies have shown dramatically improved pregnancy rates by grazing     the innermost lining of the uterus (the endometrium) with a small flexible catheter weeks     prior to embryo transfer. These studies were all performed outside the United States (U.S.)     in women with multiple failed IVF attempts and did not investigate the mechanisms by which     endometrial injury works. This study will be the first to evaluate the effect of endometrial     injury on IVF success in all women undergoing IVF, including first IVF cycles, frozen embryo     transfers, and donor eggs.   "
86527|NCT02153476|"     Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human     subjects with symptomatic focal vitreomacular adhesion   "
86505|NCT02153762|"     The purpose of this study is to evaluate the safety and tolerability, as well as     effectiveness, with regards to the order of application for Locoid Lipocream and Hylatopic     Plus cream in patients with atopic dermatitis (AD), which is a type of skin rash.Topical skin     barrier repair therapies (BRT) that are plain moisturizing creams/lotions with added lipids     (fats/oils), such as Hylatopic Plus cream, have emerged as an effective addition to the the     treatment of atopic dermatitis. BRTs are often used along with topical steroids (medicated     creams), such as Locoid lotion, on skin with AD, and as a monotherapy (single treatment) on     both non-diseased and diseased skin. Since BRTs help to restore components of skin that are     absent in skin with AD, it is believed that long-term BRT use may reduce further development     of further AD. This is an open-label, single site study.   "
86506|NCT02153749|"     The investigators propose that brief training in regulation of craving may increase the     efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based     strategies may operate via different psychological and neural mechanisms.   "
86507|NCT02153736|"     The primary aims of this randomized controlled trial are to evaluate efficacy potential of     SPEEDI at enhancing reaching and play based problem solving compared to infants receiving     usual care.   "
86508|NCT02153723|"     A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading     known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic     name - Glatiramer acetate) is medication FDA approved for the treatment of multiple     sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients     for more than 12 years.   "
86510|NCT02153697|"     Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals.     Their removal may be requested for aesthetic reasons.      The goal of the study is comparing the efficacy and tolerance of two different therapy     modalities established for treating solar lentigines.      The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser,     the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm®     cream).      The investigators estimate that a physical therapy with a Q-switched Rubin laser system is     more effective in the removal of solar lentigines than a topical chemical therapy with a     hydrochinon containing bleaching cream.   "
86511|NCT02153684|"     The Canadian Respiratory Research Network (CRRN) has recently been established to study the     origins and evolution of airways disease in the population. The CRRN is funded by the     Institute of Cardio-respiratory Health (ICRH), an institute of the CIHR. The Physiology     platform will support the other CRRN platforms (biology, imaging, population health,     knowledge transfer) by providing a comprehensive characterization of the nature and extent of     physiological impairment of respiratory function in smokers at risk for airways disease and     in those with early or mild airway obstruction. The planned studies of the physiology group     (core sites located at Queen's University, University of British Columbia and McGill     University) will initially focus on smoking-related lung injury in those at risk for COPD and     in those meeting spirometric criteria for mild airway obstruction, with or without     respiratory symptoms. The primary aim of this initial study is to identify and validate     sensitive test(s) of peripheral airway dysfunction that may qualify as physiological     biomarkers for use in future CRRN studies.   "
86512|NCT02153671|"     This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can     induce a long-lasting immune memory by comparing the immunologic response to two doses of the     OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who     did not received LAIV.   "
86513|NCT02153658|"     The PrePex is a WHO prequalified medical device for adult male circumcision for HIV     prevention. The Government of Rwanda was the first country to implement the PrePex and acts     as the leading Center of Excellence providing trainings and formal guidelines. As part of the     Government's efforts to improve the PrePex implementation, it made efforts to improve the     psychology acceptability of the PrePex by men and thus to increase the uptake with VMMC in     sub-Saharan Africa.      Some men who gone through the PrePex procedure complained of foreskin odor while wearing the     PrePex 3-7 days after it is placed. This complaint was identified as potential risk for the     PrePex uptake. Researchers from Rwanda assumed there is a possible relation between the level     of foreskin odor to the patient foreskin hygiene technique. It was speculated that a patient     that follows an appropriate foreskin hygiene technique while wearing the device will have a     significantly lower foreskin odor on day 7 than a patient who does not follow such technique.     The Government of Rwanda decided to investigate those assumptions in a scientific way and     conduct a study to test different hygiene cleaning methods in order to increase the     acceptability of PrePex and mitigate the odor concern.   "
86514|NCT02153645|"     Amantadine has been used for many years as a treatment for Parkinson's disease. It has been     reported in the literature to effectively treat the motor complications of levodopa,     especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of this     multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the     efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to     placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's     disease. The dose will be given once a day in the morning so that amantadine concentrations     are maintained throughout the day for treating the levodopa induced dyskinesia, but will be     lower during the night, potentially reducing the negative impact of amantadine on sleep.   "
86515|NCT02153632|"     Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It has     been reported in the literature to effectively treat the motor complications of levodopa,     especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of this     multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the     efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to     placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's     disease. The dose will be given once a day in the morning so that amantadine concentrations     are maintained throughout the day for treating the levodopa induced dyskinesia, but will be     lower during the night, potentially reducing the negative impact of amantadine on sleep.   "
86516|NCT02153619|"     Many parents who have lost a child use counseling or other resources to help with the     emotional burden of their loss. The aim of this study is to begin to test a new counseling     program for parents who have lost a child to cancer.   "
86517|NCT02153606|"     All premature babies have problems with feeding and nutrition. Some can develop a     life-threatening bowel infection necrotizing enterocolitis. This can result in the need for     emergency surgery, loss of bowel, lifelong feeding problems, and death. Giving premature     babies glycerin suppositories may be one way to stimulate the digestive tract and help     prevent these problems. To see if this treatment works, the investigators need to study     hundreds of premature babies in a large trial involving multiple hospitals. The purpose of     this project is to carry out a small study first and make sure that the larger trial is     feasible. The investigators will invite approximately 30 premature babies from the Neonatal     Intensive Care Unit at McMaster University Medical Centre to participate in this study over a     6-month period. The investigators will focus on feasibility issues, including cost, safety,     and rate of participation. This will allow us to rigorously test our study protocol and lay     the groundwork for the larger study involving multiple hospitals.   "
86518|NCT02153593|"     Massive bone tumour resection is often associated with important postoperative bleeding. This     may determine systemic (anaemia), as well as local complications (wound healing, seroma,     haematoma).      The objective of this study is to determine whether the use of topical tranexamic acid or     topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.   "
86519|NCT02153580|"     This phase I trial studies the side effects and best dose of cellular immunotherapy following     chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia or     B-cell prolymphocytic leukemia that has come back. Placing a modified gene into white blood     cells may help the body build an immune response to kill cancer cells.   "
86520|NCT02153567|"     Background:      Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of     functional dyspepsia (FD) is uncertain. Clinical experience and community studies show that     FD is strongly associated with common mood disorders especially depression and anxiety     disorders, which can be treated with serotonin selective uptake receptor (SSRI).      Our previous study shows that the relief of FD symptom has an association with the change of     plasma serotonin and ghrelin profile. However, the correlation between plasma serotonin level     in FD patients treated with SSRI is lacking in these studies.      Indication:      Functional dyspepsia patients      Study center(s):      Prince of Wales Hospital, Hong Kong      Aims :        -  To evaluate the effect of SSRI treatment on change of plasma serotonin level        -  To evaluate the relationship between dyspeptic symptom and change of plasma serotonin          level      Study medication:      Escitalopram (Lexapro) 5mg daily for first 2 weeks, and then 10 mg daily for 8 weeks versus     Placebo for 10 weeks      Study design:      Double-blind randomized placebo-controlled trial      Number of subjects:72      - 36 patients (18 male and 18 female) and 36 age-and-sex-matched healthy controls      Patient population:      Functional dyspepsia patients age 18-60, with element of anxiety or depression      Duration of study: 1 June 2013 - 30 November 2015      Primary variable(s):      Change of serotonin and ghrelin level in blood plasma after medication treatment      Secondary variable(s):      Rate of adequate relief using global symptom assessment and symptom scores      Number of visits: 2   "
86521|NCT02153554|"     The purpose of this study is to determine whether the training of civil servants leads to a     reduction in the violence suffered by women, as well as in their psychological wellbeing and     attitudes towards violence.   "
86535|NCT02153372|"     In the present phase-I clinical trial we investigate safety and feasibility of an     augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in     combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral     fractures.   "
86522|NCT02153541|"     This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults     with poorly controlled moderate to severe asthma. The researchers believe that by using a     local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma,     such as decreasing the numbers of times patients have to use a rescue inhaler, and improving     asthma treatment assessment questionnaire scores, with no bad changes to lung function and     inflammation.   "
86523|NCT02153528|"     - Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion     using vital staining reduces unfavorable outcome of Cat. 1 first-line TB treatment without     excess serious toxicity, and allows early switch to specific treatment of MDR-TB without     using Cat. 2 retreatment regimen      - General study design: This open label, randomised clinical trial is intended as a pilot     study on the efficacy and safety of high-dose rifampicin and feasibility and added value of     auramine and/or FDA vital staining sputum smear after 2 weeks of intensive treatment phase.     If this proof-of-concept study provides substantial indication of benefit without indication     of excess toxicity, the data from the study will be used to design a larger scale,     cluster-randomized study. The aim of this cluster randomised study would be to provide     definite proof of the benefit of the intervention on adverse treatment outcomes and lack of     excess toxicity associated with high dose rifampicin. In addition, the cluster-randomized     study would provide a more precise assessment of the suppression and prevention of (acquired)     resistance endpoints.      An interim analysis is thus planned at the time the last recruited patient finishes     treatment, i.e. about 9 months after the end of recruitment. It will focus on assessment of     drug toxicity versus suggested benefits of the intervention. This analysis will be primarily     performed for the go/no-go decision and design considerations for the cluster-randomized     trial. The decision on proceeding to the cluster randomized study will be based on the     absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding     relapse), and possible favourable effects on initially present low-resistance mutations /     mutations acquired during treatment. It will also allow to adapt the design of the larger     study particularly regarding the algorithm for resistance screening, and whether or not     treatment shortening could be justified with rapid initial conversion.   "
86524|NCT02153515|"     To investigate if fresh finger prick autologous blood (FAB) instead of serum from     venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial     defects. Currently there are no studies on the use of whole fresh blood for the treatment of     chronic ulcers, persistent epithelial defects or dry eyes. Unpublished case reports indicate     that fresh blood can be an effective tool to the treatment of corneal pathology.   "
86525|NCT02153502|"     The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability     of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive     disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A     secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and     potential correlations with pharmacodynamic effects.   "
86526|NCT02153489|"     The purpose of this study is to assess the effect of aclidinium bromide compared with placebo     in improving dilatation of the airways (bronchodilation), symptoms of chronic obstructive     pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of treatment with     aclidinium bromide 400 μg administered twice daily in patients with stable     moderate-and-severe COPD.   "
86528|NCT02153463|"     Tics are brief repetitive movements or vocalizations. Gilles de la Tourette's syndrome (TS)     is a disorder characterized by recurrent motor and vocal tics. Tourette syndrome and tic     disorders affect up to 8% of children. Peak severity of tic disorders occurs between the ages     of 8 to 12 years, therefore during childhood and adolescence the most significant impacts are     felt. The quality of life of young people with tics is lower than their peers' and tic     severity predicts lower quality of life. Studies have also shown negative social perception     toward children with tics.      Approximately 50% of patients with Tourette syndrome will have other diagnoses including     attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder, anxiety and     depression. Studies have shown improvements in ADHD with physical activity. ADHD and tic     disorders are thought to involve the same areas of the brain; thus it is possible that tics     might also improve with physical activity. However, no studies to date have examined this.     The investigators predict that by implementing a motivational physical activity program, in     conjunction with physical activity counseling, the investigators will be able to increase     levels of physical activity in children with tics and Tourette syndrome, with a positive     impact on tic severity.   "
86529|NCT02153450|"     This pilot clinical trial studies stereotactic radiosurgery and metformin hydrochloride in     treating patients with pancreatic cancer that may be removed (borderline-resectable) or not     removed by surgery. Stereotactic radiosurgery may be able to send x-rays directly to the     tumor and cause less damage to normal tissue. Metformin hydrochloride, used for diabetes, may     also kill cancer cells as demonstrated in laboratory studies. Giving stereotactic     radiosurgery with metformin hydrochloride may kill more tumor cells.   "
86530|NCT02153437|"     To determine the effect of our compound (BMS-919373) on electrical activity of the heart     using pacemakers.   "
86531|NCT02153424|"     The primary objective of the study is to identify and describe any suspected (AEs) in all     patients with NVAF treated with Apixaban, as a request of the National Center of     Pharmacovigilance (CNFV) in Mexico.   "
86532|NCT02153411|"     Descriptive study on the management of asthma in asthmatic Middle East adult population :     Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE   "
86533|NCT02153398|"     The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and     efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in     Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are     suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU),     non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison     syndrome.   "
86534|NCT02153385|"     Background: Women are more likely to suffer from depression and anxiety, which have been     linked to reduced heart rate variability (HRV) and increased cardiovascular morbidity and     mortality. The purpose of this study was to examine the effects of an 8-week yoga program on     HRV and mood in generally healthy women. The investigators hypothesized that there would be     improvements in HRV and reductions in perceived stress and symptoms of depression and anxiety     after the yoga intervention.      Methods: Fifty-two healthy women were randomized to either a yoga group or a control group.     Participants in the yoga group completed an 8-week yoga program, which comprised a 60-minute     session, twice a week. Each session consisted of breathing exercises, yoga pose practice, and     supine meditation/relaxation. Participants' HRV, perceived stress, depressive symptoms, and     state and trait anxiety were assessed at baseline and week 9.   "
86536|NCT02153359|"     This study is about asthma and how the environment affects asthma. Scientists know that air     pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms     worse. This research is being done to study how the health of a person with asthma responds     to an air cleaner. The investigator hypothesize that an air cleaner will improve the health     of persons with asthma.   "
86537|NCT02153346|"     Rationale Asthma is a chronic inflammatory disorder of the airways affecting persons of all     ages and is recognized as one of the most common chronic diseases. Canada has one of the     highest asthma prevalence rates in the world (8.5%, aged 12 and over) and it is a major cause     of hospitalization. The cost of asthma varies dramatically across disease severity, and it is     expected that these costs are greater when the condition is sub-optimally managed and     controlled. Although a number of publications have been reported on the economic burden of     asthma, there is a lack of information on the cost of asthma based on disease severity and     level of disease control in Canada. The proposed study aims to i) estimate the annual     indirect cost of asthma and ii) the impact of asthma on absenteeism, presenteeism and work     productivity in Canada. This information is essential to further quantify the burden of     asthma on patients and the healthcare system in the Canadian setting.      Overall Objectives The overall objective of this study is to describe the impact of asthma on     patients with moderate to severe asthma and to estimate the indirect costs of asthma care in     asthmatic patients followed in tertiary clinics specialized in the field of asthma in Quebec,     Canada.      Study Design      A prospective cohort study will be conducted to measure the indirect economical burden of     asthma on patients. Patients will be selected and recruited from the BD-Asthma registry and     followed prospectively for 1 year. Recruited patients will be asked to complete     questionnaires at regular intervals for 1 year to measure indirect cost of disease, using the     Valuation of lost productivity (VOLP) questionnaire.      Data Collected For each patient, the following data will be collected        -  Patient demographics        -  Age        -  Sex        -  Income        -  Level of education        -  Smoking        -  Disease management and Treatment utilization in the year prior to recruitment        -  Physician visits and follow up        -  Hospitalizations (number and total days)        -  Emergency room visits        -  Disease characteristics        -  Asthma history        -  Year of first diagnosis of asthma severity        -  Asthma Control Questionnaire score        -  Lung function measures      Data Analysis Methods For each participant, the percentage of time missed from work over a     year will be calculated. We will use the human capital approach to calculate the costs of     asthma due to lost productivity, incorporating both absenteeism and presenteeism in the     calculation of the productivity loss. We will calculate the number of work days in which the     person was unable to attend the workplace, and the number of days and percentage of time lost     during the days the person's work was affected by their asthma. The fraction of time lost     from work in the past year will be multiplied by the average income in Quebec. Finally, this     value will be multiplied by the coefficient generated by the VOLP, which reflects the     relative value of the productivity loss. In addition, we will calculate the VOLP multiplier     for each participant which, combined with the percentage of time missed from work, will     create a measure of productivity loss adjusted for the relative importance and     replace-ability of the participant's profession.      Sample Size and Power      One hundred subjects will be randomly selected from the BD-Asthma registry.      Limitations      The study population may not be representative of the general asthma population, as moderate     to severe asthma will be over represented in these tertiary centers.   "
86538|NCT02153333|"     This study aims to evaluate the serologic response to PCV-1 in the serum samples previously     collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies     (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera     samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time     point will also be evaluated.   "
86539|NCT02153320|"     The purpose of this long-term follow-up study was to evaluate the persistence of the cellular     and the humoral immune response 4 years after the first dose of GSK Biologicals'     investigational vaccine formulations containing HBsAg (used as a model antigen) and an     adjuvant.   "
86540|NCT02153307|"     The purpose of this study is to determine the incidence and predictors of high degree or     complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset     persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve     implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac     Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant     arrhythmias in patients with NOP-LBBB following TAVI.   "
86541|NCT02153294|"     The purpose of this national multicentre randomized controlled trial is to compare a     ventilation strategy using lower tidal volumes and higher respiratory rates with a     ventilation strategy using higher tidal volumes and a lower respiratory rate in intubated and     ventilated intensive care unit (ICU) patients without Acute Respiratory Distress Syndrome     (ARDS) at start of ventilation.      Participating centres in The Netherlands will include a total of 952 adult patients admitted     to intensive care units without ARDS. Patients are randomized and ventilated with either a     strategy with lower tidal volumes (4 to 6 ml/kg predicted body weight (PBW)) or a strategy     with higher tidal volumes (8 to 10 ml/kg PBW). Patients will be assessed every day until day     28 or discharge of the intensive care unit, whichever comes first, on day 28 and on day 90.     Primary endpoint is the number of ventilator-free days at day 28. Secondary endpoints are     ICU- and hospital length of stay (LOS) and - mortality, the incidence of development of ARDS,     pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of sedatives, and     neuromuscular blocking agents, incidences of ICU delirium and ICU acquired weakness,     patient-ventilator asynchrony and the need for decreasing of instrumental dead space.   "
86542|NCT02153281|"     The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution     volume (VT), after phenelzine treatment and if so to what extent.   "
86544|NCT02153255|"     Mucopolysaccharidosis Type IVa (MPS IVa, Morquio Disease) is a rare inherited lysosomal     storage disorder caused by deficiency of the enzyme galactose-6-sulfatase.      Children with this disease accumulate a chemical called keratan sulphate, which stops their     skeletons developing properly. They are very short in stature and many of their joints are     unstable. Children with MPS IVa walk in a different way to other people due to a combination     of lax ligaments and skeletal problems such as knock-knees.      Human walking involves the coordinated movements of all four limbs. As we walk, the arms     swing oppositely to the legs. This movement pattern is very different in children with MPS     IVa. This change seems to involve the whole musculoskeletal system and depends on the     severity of the disease.      Recent studies in children with MPS IVa describing walking pattern have concentrated solely     on the lower or upper limb respectively, and have not looked at the interaction of the upper     and lower limbs during walking.      To our knowledge, the mechanics of walking in children with MPS IVa has not been investigated     using a dynamic gait analysis tool (using cameras, sensors and electrodes to track the     movements of different parts of the body during walking) and we aim to characterise this in a     small number of children with MPS IVa and also examine the effects of splinting the wrist     upon the walking pattern to see if this simple intervention makes it easier or more difficult     for children with MPS IVa to walk.   "
86545|NCT02153242|"     This is a pilot study into the effects on heart function when pacing the right ventricle     (RV). This study aims to enrol a population with structurally normal hearts. The     investigators aim to measure heart function directly when pacing.      When normal conduction within the heart fails, the treatment may be to implant a permanent     pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical     impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been     shown to be less efficient than the normal conduction system of the heart and in some cases     leads to markedly reduced function. What the investigators do not know is why this is the     case.      Much effort has been directed at looking at features within the left ventricle (LV) for     markers of disease progression but little has been investigated regarding the RV.      There may be some benefit to pacing the heart preferentially from different parts of the RV     and the investigators aim to measure if any differences are detectable from stimulating the     heart at various sites within the RV.   "
86546|NCT02153229|"     A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated     photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the     treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given     the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking.     Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic     light dosimetry.   "
86810|NCT02149784|"     There is still no perfect treatment suggestion for patients with asymptomatic colorectal     cancer with unresectable metastatic disease. Whether patients can benefit from palliative     resection of primary tumor or not is still waiting for answer. The investigators hypothesis     that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will     benefit from primary tumor resection.   "
86547|NCT02153216|"     This study is the Formative Phase of a larger study; once this phase is completed, enrollment     into the randomized controlled trial (RCT Phase) will begin. The primary objective of the     Formative Phase is to gain a better understanding of the context in which drinking alcohol     among ART client in Vietnam occurs, in order to culturally tailor the intervention to be     tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth     interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics     in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the     ART clinics (whom we will refer to as general population PWID).   "
86548|NCT02153203|"     Children with autism spectrum disorders often engage in problem behaviors such as     self-injury, destruction, aggression, and stereotypy. Prior research has clearly shown that     these problem behaviors may interfere with learning, daily functioning, and social     participation. As such, engaging in problem behaviors has a negative impact on the health and     quality of life of children with autism spectrum disorders and their families. One promising     solution to reduce problem behaviors in this population is the Prevent-Teach-Reinforce (PTR)     model, which relies on the evidence-based practices of positive behavior support. Although     the use of PTR has been gaining considerably support in schools, the model has never been     evaluated as part of a rigorous large-scale study using parents as interventionists. Thus,     the purpose of the project is to conduct an assessment of the effectiveness of a home-based     version of the PTR model in reducing problem behaviors in children with autism spectrum     disorders and in improving families' quality of life. Our hypotheses are that implementing     the PTR will (a) produce larger reductions in problem behaviors than participating in an     individual parent training session, (b) increase engagement in prosocial behaviors, (c)     decrease parental stress, and (c) improve the quality of life of the family. The results of     the study will allow an examination of whether PTR is an effective and acceptable model to     reduce problem behaviors at home in this population. Given that problem behaviors incur high     societal costs when they persist into adolescence and adulthood, the study may potentially     lead to large cost reductions in the treatment of difficulties associated with autism     spectrum disorders. By reducing engagement in problem behaviors, the implementation of the     model may also promote and facilitate the social participation as well as improve the quality     of life and health of children with autism spectrum disorders and their families.   "
86549|NCT02153190|"     The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in     home setting in Type 1 Diabetic patients   "
86550|NCT02153177|"     The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory     Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.   "
86551|NCT02153164|"     This is a single site, prospective, non-blinded, non-randomized, non-interventional study     designed to evaluate the effect of changes in patient position on the measurement of     respiratory heat loss (enthalpy). This study would be carried out on patients whose operation     requires the use of the steep Trendelenburg position independent of this study.   "
86552|NCT02153151|"     This pilot research trial studies the response in blood cells to AMP-514, a drug shown to     increase immune response (capacity to fight against infections and cancer) against cancer in     patients with solid tumors undergoing radiotherapy. Measuring changes in biomarkers may help     doctors decide if AMP-514 should be combined with radiotherapy and when is the best time to     combine the drug with radiation.   "
86553|NCT02153138|"     The investigators' hypothesis is that a plant-based diet may be beneficial if nutritional     deficiencies will be corrected. The aims of the present proposal are to 1) study endothelial     functions of subjects on well-defined vegetarian/vegan diets compared to age and sex matched     omnivores (controls), and 2) study the differences in energy expenditure, body composition,     overnight substrate utilization, blood work results, and levels of intracellular reactive     oxygen species (ROS) and of adhesion molecules on the different diets.   "
86560|NCT02153047|"     There is controversy about the effectiveness of interventions based on spirometry for smoking     cessation.      The investigators want to evaluate the effectiveness of motivational intervention performed     by a doctor to obtain abstinence compared with normal practice in primary care.      This study, is the second half of what was began with ESPITAP study   "
86561|NCT02153034|"     Buruli ulcer is a neglected tropical disease caused by infection with Mycobacterium ulcerans     (Mu) in rural parts of West Africa. It causes large skin ulcers mainly in children aged 5 to     15 years. Access to treatment is limited and many cases present late. There have been major     advances in understanding the mechanism of disease together with improved diagnosis and     management. The aim of the proposed studies is to identify markers predictive of a rapid     response to antibiotic treatment and to investigate the pathogenesis of paradoxical reactions     and oedematous lesions in Mu disease.      Infection with Mu results in a nodule under the skin which enlarges and breaks down to form     an ulcer. This is because Mu produces a toxin that spreads outwards and damages subcutaneous     tissue. In recent years it has been found that antibiotic treatment for 8 weeks with daily     tablets and intramuscular injections heals ulcers. This is unpleasant and it would be better     if the treatment could be shortened. Our previous studies suggest this may be possible.     Therefore a wide range of tests will be investigated in order to identify markers for people     in whom the infection is at an early stage with low numbers of Mu bacteria and low levels of     toxin in the skin. During antibiotic treatment the rate of healing will be measured to find     out which markers are the most reliable.      In some patients new areas of inflammation develop despite treatment and this is called a     paradoxical reaction. The immune response to Mu will be investigated serially during     antibiotic treatment to investigate the cause of paradoxical reactions.      About 15% of patients have oedematous disease, the most severe form of Buruli ulcer. We will     study the amount of Mu toxin produced by the strain of Mu cultured from patients with this     form of the disease.      Hypothesis        -  Buruli ulcer patients that heal rapidly/slowly or develop paradoxical reactions with          treatment will have associated predictive viability or serum biomarkers.        -  Buruli ulcer patients with oedematous disease are associated with larger amounts of          mycolactone and viable organisms   "
86811|NCT02149771|"     The purpose of this study is to determine whether TACE combined endovascular stent     implantation confers a survival benefit over TACE alone.   "
86562|NCT02153021|"     Obesity is a chronic disease of increasing prevalence, being currently considered a global     epidemic, including children, adolescents, adults and the elderly of different nationalities     and ethnicities, socioeconomic levels, education levels. Non-pharmacological therapeutic     interventions, such as physical exercise and fitness healthy eating strategies seem to be     increasingly studied and recommended for healthy weight loss. In addition, therapies that can     complement the effect of exercise and diet for reducing body weight are considerate important     strategies. Thus, experimental evidence shows that the use of laser therapy combined with     exercise swimming was effective in controlling the lipid profile, reducing the mass of     adipose tissue, suggesting increased metabolic activity and changes in lipid metabolism.      To investigate the effect of the use of therapeutic laser when associated to exercise like     response to new therapy for weight loss and decrease of dyslipidemias levels.   "
86563|NCT02153008|"     To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs     collected from symptomatic subjects.   "
86564|NCT02152995|"     This phase II trial studies how well trametinib works in increasing tumoral iodine     incorporation in patients with thyroid cancer that has come back or spread to another place     in the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth and may help make treatment with iodine I-131 more effective.   "
86565|NCT02152982|"     This randomized phase II/III trial studies how well temozolomide and veliparib work compared     to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme.     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. It is not yet known whether temozolomide is more effective     with or without veliparib in treating glioblastoma multiforme.   "
86566|NCT02152969|"     To evaluate Drug-drug interaction   "
86567|NCT02152956|"     The primary goal of this Phase 1, dose-escalation study, is to determine the maximum     tolerated dose level of MGD006 in patients with AML and MDS whose disease is not expected to     benefit from cytotoxic chemotherapy. Studies will also be done to see how the drug acts in     the body (pharmacokinetics [PK], pharmacodynamics) and to evaluate potential anti-tumor     activity of MGD006.   "
86568|NCT02152943|"     The goal of this clinical research study is to find the highest tolerable dose of Femara     (letrozole) that can be given in combination with Afinitor (everolimus) and Herceptin     (trastuzumab) to patients with advanced cancer. The safety of this drug combination will also     be studied.   "
86569|NCT02152930|"     Intermittent claudication (IC) is caused by peripheral arterial disease and has a high     morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease.     Primary treatment consists of cardiovascular risk management and improvement of functional     capacity with supervised exercise therapy (SET). A potential additional therapy is the     administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated     Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved     hemorheological parameters such as erythrocyte deformability and aggregation, and a number of     cardiovascular risk factors. Hemorheological parameters determine the blood flow in the     microcirculation, which is of main importance in patients with IC since the macrocirculation     is compromised. Inflammation is considered an important etiologic factor in the pathogenesis     of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also     have a strong anti-inflammatory effect, they might be effective in patients with IC by     lowering the inflammatory response. In addition, visceral fat rather than obesity in general     has been recognised as an etiologic and prognostic factor in atherosclerosis.      We hypothesise that the administration of omega-3 PUFA's in patients with IC has a     synergistic effect with SET and improves walking distance after SET, by improving     hemorheological parameters resulting in a better microcirculation. Second, we hypothesise     that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo     stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a     decrease in visceral fat mass.   "
86582|NCT02152761|"     The purpose of this study is to assess if bimagrumab is safe and effective in patients with     muscle wasting (atrophy) after hip fracture surgery.   "
86689|NCT02151370|"     This observational study will collect data about safety in female patients with advanced     ovarian epithelial cancer with measurable residual disease after surger y. The treating     physician has decided to treat the patients with Avastin (bevaci zumab) in combination with     chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be     collected for 72 weeks.   "
86570|NCT02152917|"     The total knee arthroplasty (TKA) is a well established option for the treatment of     osteoarthritis in this joint. Nevertheless, there are still some concerns related to the     peri-operative management of elderly patients, highlighting the complications related to     medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease     postoperative bleeding, which has been accumulating favorable evidence, is the use of     tranexamic acid (TA). Several studies (including prospective randomized trials with placebo     group) showed excellent results with TA intravenous administration during TKA, reducing the     amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another     alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of     thrombin and bovine gelatin. This substance has presented significant benefits on bleeding     control in several areas of medicine, including orthopedic surgery, but no action has yet     been established in TKA. The main objective is to evaluate the amount of bleeding, the drop     in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal®     and a control group. The secondary objective is to evaluate the rate of adverse events in the     studied groups.   "
86571|NCT02152904|"     The purpose of the investigators study is to investigate the factors associated with     rebleeding in patients with peptic ulcer bleeding.   "
86812|NCT02149758|"     The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal     inflammation by:        1. improving clinical periodontal parameters and,        2. improving the salivary SOD levels.   "
86813|NCT02149745|"     The purpose of this study is to find if we can shorten the recovery time by calling the     patient's name during anesthesia reversal.   "
86573|NCT02152878|"     Non-invasive brain stimulation therapies have been increasingly investigated in recent years     as a treatment for neuropsychiatric disorders, particularly mood disorders. They are     particularly appealing since many patients are either refractory or present side effects to     standard pharmacological regimens. TDCS (transcranial direct current stimulation). a novel     non- pharmacological brain stimulation technique, might help in overcoming some of these     issues, since it has low cost, high portability and it is relatively easy to use. TDCS     consists in applying a weak, direct current through two electrodes placed over the scalp; the     anode and the cathode increasing and decreasing cortical excitability during and beyond the     period of stimulation. It is also a safe technique with only mild adverse effects described.     Previous studies, some of them from our group, have described that tDCS is an effective     technique for major depression. However, the role of tDCS as a treatment for bipolar     depression (BD) has been insufficiently investigated. Therefore, our aim is to address the     antidepressant effects of tDCS in BD in a randomized, sham- controlled trial in a refractory     sample.   "
86574|NCT02152865|"     For the chemical lupeol isolated from eggplant, we applied it to one side of face, and     applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week,     randomized controlled, split face fashion. Investigators evaluated safety and efficacy during     baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.   "
86575|NCT02152852|"     The purpose of this study is to test the hypotheses that CHWs providing in-home support for     self-management of type 2 diabetes, resources for diabetes, and assistance in effective     linkage and communication with medical providers will: (1) improve HbA1c (primary outcome)     and secondary outcomes including lipids, blood pressure, health care utilization, and     health-related quality of life; (2) improve diabetes self-management, including     self-efficacy, physical activity, nutrition, and medication adherence; and (3) be     cost-effective and feasible.   "
86576|NCT02152839|"     Maintenance of body's skeletal muscle is key to a healthy older age. However, as we age we     lose on average 1-2% of our muscle each year. In order to slow this loss we need to     understand fully the mechanisms regulating muscle mass with ageing. In this project we aim to     determine these mechanisms using a new novel technique of 'heavy' water ingestion, which will     allow us to measure multiple aspects of skeletal muscle mass control during normal everyday     activities in young and old individuals over a period of 6 weeks. We will also determine the     influence of resistance exercise training during this period in offsetting declines in muscle     with ageing using this method   "
86577|NCT02152826|"     This study will compare the safety and effectiveness of two water-based potassium oxalate     desensitizers on existing dentinal hypersensitivity.   "
86578|NCT02152813|"     This proposed study aims to compare the effects of unilateral and bilateral transcutaneous     electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS +     task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength,     co-ordination, dynamic standing balance, walking performance, and functional mobility in     patients with chronic stroke.      The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not     significantly different in promoting the recovery of these functions.   "
86579|NCT02152800|"     The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in     patients with acute herpes zoster.   "
86580|NCT02152787|"     The occurrence of emergence agitation (EA) in pediatric patients who have received     sevoflurane anesthesia is a common postoperative problem. Among various strategies for     reducing the incidence and severity of EA, the use of pharmacological agents at the end of     anesthesia is thought to be the most convenient and easily applicable method in clinical     situation. The one of typical agents that can be administered in this way is propofol.     Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could     reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However,     it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay     the emergence time. The purpose of this study is to compare the preventive effect on EA and     the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of     sevoflurane anesthesia.   "
86581|NCT02152774|"     To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%)     ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6     months.      Secondary Outcome      Secondary objectives are:        1. To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular          pressure (IOP).        2. To evaluate the long term effect of the drug on IOP.        3. To determine if AR-12286 can be used as directed therapy for CACG, reducing or          eliminating the structural blockage of the trabecular meshwork that leads to development          of elevated IOP.   "
86583|NCT02152748|"     Summary of scientific evidence and rationale of this project:      Integrative molecular-genetic approaches have provided important insights in the biology of     glioblastoma. It has meanwhile become clear, that glioblastoma is not a single tumor entity     but comprises different molecular subtypes, which are associated with a distinct     genetic/epigenetic signature and prognosis. Multimodal treatment approaches combining radio-     and chemotherapy as well as the recent introduction of novel antiangiogenic agents have     resulted in increasing survival times and improved quality-of-life of glioblastoma patients.     Yet, despite these intense treatment efforts the therapeutic efficacy in glioblastoma     patients is limited, leading in virtually all cases to tumor recurrence and death of the     patients.      As only a limited fraction of glioblastoma patients undergo second neurosurgery at tumor     recurrence (< 10%), post-therapeutic samples are rare and no systematic, large-scale studies     exist, which address post-therapeutic morphological and molecular alterations in glioblastoma     tumor tissue. Yet, these data would help to improve the understanding of mechanisms involved     in therapy-resistance and tumor progression, to develop new therapeutic approaches and could     pave the way for personalized treatment strategies.   "
86814|NCT02149732|"     To investigate the effect of ocular surface reconstruction and assess the safety in     cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with     cicatricial change of ocular surface.   "
86584|NCT02152735|"     PURPOSE:      To test the hypothesis that omission of intrauterine cleaning during cesarean deliveries does     not increase intraoperative and postoperative complications.      METHODS:      We plan to randomize 206 women undergoing primary and repeat cesarean deliveries to cleaning     (n=103) versus no cleaning (n=103) of the uterine cavity following placental delivery. Women     will be excluded if any of the following criteria are encountered: preterm premature rupture     of membranes, spontaneous rupture of membranes prior to cesarean section, chorioamnionitis,     fetal demise, uncontrolled diabetes or an immunosuppressive disorder. Primary outcome measure     will be endo-myometritis after delivery. Secondary outcomes will include post partum     hemorrhage, mean surgical time, retained products of conception, retained placenta,     quantitative blood loss, length of hospital stay, return of gastrointestinal function, repeat     surgery, and hospital readmission rates. Analysis will follow the intention-to-treat     principle.      GENERAL DESIGN All eligible patients who are scheduled for cesarean section at the Sparrow     hospital/Michigan State University Resident OBGYN and Perinatology clinics will be evaluated     for study inclusion. Patients meeting this study's inclusion criteria and lack exclusion     criteria will be approached for consent and enrollment.   "
86585|NCT02152722|"     The effect of radiation on normal tissue varies widely between individuals. Consequently, a     test to measure tissue response to radiation could be clinically useful by permitting more     accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging     concerns about possible nuclear terrorism a test for exposure to radiation might also be     useful in evaluating victims of a dirty bomb explosion. A number of different techniques     have been previously reported in epidemiological studies for the estimation of prior     radiation exposure. This study explores one approach to estimating radiation exposure by     measurement of increased oxidative stress which can be detected by a breath test.      In this study subjects undergoing significant exposure to therapeutic radiation will provide     breath samples for analysis in a central laboratory. The hypothesis of the study is that the     analysis of these samples will lead to the identification of a set of markers of radiation     exposure.   "
86586|NCT02152709|"     The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml     and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in     saccharomyces cereviside yeast for infants and other age groups.   "
86587|NCT02152696|"     This is a randomized controlled trial to compare three currently available management     strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them     at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed     PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by     methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy)     2) Empiric treatment with MTX for all 3) Expectant management. Randomization will be 1:1:1     into these three arms. After randomization, they will be followed and treated clinically as     is indicated by the progression of their condition. Primary outcome measures: uneventful     decline of hCG to 5 IU/mL.   "
86588|NCT02152683|"     The study is aimed at comparing the performance of protocols employing one and two sessions     per week, respectively. The study hypothesis claims that there is no significant difference     between the performances of the compared protocols.   "
86589|NCT02152670|"     Studies using positron emission tomography (PET) have been used with great success in     demonstrating specific abnormalities in several facets of dopaminergic system function in     human populations (Narendran and Martinez 2009). Among the first, most consistent, and     broadly replicated of such findings in drug‐ (including cocaine) dependent individuals has     been the reduction in subcortical (striatal) D2/3 receptors as imaged, most commonly, by the     reversible, non‐selective, D2/3 receptor antagonist radiotracer, [11C]raclopride. Certain     dissociations on D2/3 availability by radioligand ([11C]raclopride vs. [11C]PHNO) and by     brain region (striatum vs. SN; terminal vs. somatodendritic, respectively) are poorly     understood in relationship to prior antagonist tracer results. In the current study the     investigators will use pharmacological interventions (AMPT and methylphenidate) with both     antagonist and agonist radiotracers to experimentally reconcile these discordant findings and     clarify potential mechanistic inter‐relationships.   "
86590|NCT02152657|"     The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell     transplantation through percutaneous injection in patients with chronic spinal cord injury.   "
86591|NCT02152644|"     This is a cross sectional study to estimate the prevalence of the presence of amyloid     deposits in a biopsy of subcutaneous fat cell, carpal flexor retinaculum and synovial tissue     sheath of the flexor tendons requirement for carpal tunnel surgery.   "
86592|NCT02152631|"     The main purpose of this study is to evaluate how safe and effective the study drug known as     abemaciclib is in participants with lung cancer.   "
86593|NCT02152618|"     The intervention provides services to children with Serious Emotional Disturbance (SED) who     are in foster care and to their parent(s) to prepare the families for reunification.   "
86594|NCT02152605|"     This study is a 12-week, multicenter, randomized, double blind, parallel group,     placebo-controlled study.      The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25     microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory     Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in     the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it     provides an objective measure to support the subjective patient reported outcomes of SGRQ and     rescue medication use. The study is intended to provide additional evidence to support the     use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be     randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks of     treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1     ratio. All treatments will be administered once-daily in the morning via a Dry Powder Inhaler     (DPI).      There will be a total of 5 clinic visits. The total duration of study participation will be     approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as     needed for the relief of COPD symptoms throughout the run-in and double-blind treatment     periods.   "
87650|NCT02138786|"     This is a multi-center, Phase 2, single arm, open-label study of oral selinexor monotherapy     in patients in patients with Richter's transformation, arising in the setting of prior CLL,     after at least one chemo-immunotherapy regimen for CLL.   "
86595|NCT02152592|"     the primary objective of this study is to assess and compare the efficacy, safety and     benefits of Controlled Release (CR) oxycodone/paracetamol with our current pain protocol     (paracetamol/naproxen) in the treatment of acute postoperative pain at home after painful     day-case surgery. We hypothesize that ambulatory patients postoperatively treated with     oxycodone/paracetamol will achieve better pain relief with equal side effects compared to     patients treated with paracetamol/naproxen.      Our second goal is to assess analgesic adherence in the outpatient setting.      Endpoints:      Primary endpoints: pain intensity (Visual analogue scale) Secondary endpoints: -     side-effects/ adverse effects of study medication        -  patient satisfaction with pain treatment        -  compliance to study medication      Study design:      Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or     laparoscopic inguinal hernia repair) will be enrolled in an open randomized controlled trial     (RCT) at our pre-assessment clinic.      Subjects will be enrolled by a study nurse and will be randomized into one of three study     treatment groups using a computer-generated list. Patients in group 1 (PCM/NAPR) are assigned     to postoperative analgesia using naproxen 500 mg orally twice a day for 48 hours     postoperatively. Patients assigned to group 2 (PCM/Oxy1) receive CR oxycodone 10 mg orally     twice a day for 24 hours. Patients in group 3 (PCM/Oxy2) are postoperatively treated witch CR     oxycodone 10 mg orally twice a day for 48 hours. All patients also receive paracetamol 1000     mg orally four times a day for 48 hours postoperatively.      Recovery after discharge will be assessed using a diary for up to 48 hours after surgery.     Three times a day, patients have to rate pain at rest and movement (VAS), fatigue, nausea,     vomiting, pruritus, miction problems, pyrosis, and abdominal complaints. Furthermore,     compliance to the use of the study medication will be assessed by checking whether the     patients took the study medication as prescribed and if any other pain medication was used.     Compliance will be assessed three times a day and patients will be divided into three groups     according to medication use: always = full compliance, sometimes = partial compliance, or     never = no compliance.      Finally, overall satisfaction with the postoperative pain treatment will be assessed (score     0-10).   "
86596|NCT02152579|"     Phase III clinical study for the evaluation of clinic and cardiologic effects of isosorbide     mononitrate from the incidence of events (angina episodes).      This is an open, comparative, monocentric trial. The hypothesis, regarding the number of     angina episodes, to be tested are:        -  H0: μD = 0 ot H0: μAfter = μBefore        -  HA: μD ≠ 0 ot HA: μBefore ≠ μAfter   "
86597|NCT02152566|"     Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the     blood during the night, which has been shown to contribute to a range of morbidities.      The purpose of this study is to assess the possibility that a nasal high flow therapy device     may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing     reduction in blood oxygen.      Heart failure patients will be screened at a heart failure clinic, and will be asked to     undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies     during sleep. This sleep study may be completed in the sleep laboratory (attended     polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with     respiratory insufficiencies, they will be asked to attend further overnight studies to see if     treatment with nasal high flow therapy can be used to stabilize breathing.   "
86598|NCT02152553|"     The investigators have shown that patients with adrenal insufficiency (Addison's disease), a     rare disorder, have doubled the expected mortality rate in Sweden despite Standard of Care     glucocorticoid (GC) replacement. One % of the Swedish population are, however, receiving GCs     for inflammatory diseases, but management is empirical and adjusted to underlying disease     activity. The desired anti-inflammatory therapeutic effects cannot be differentiated from the     adverse metabolic (osteoporosis, obesity, diabetes mellitus) and immunosuppressive side     effects of GC. This frequently results in suboptimal GC therapy with adverse effects due to     over-dosing or poor efficacy due to under-dosing. The primary aim is to identify a biomarker     for the metabolic effects of GCs. Patients with Addison's disease completely lack endogenous     GCs and can therefore be considered a human GC knock-out model. They can therefore be studied     during near-physiological exposure and during GC starvation. This will uniquely allow a very     clean biomarker identification model (using transcriptomics, proteomics and metabolomics).     The secondary aim is to validate candidate biomarker(s) in a dose-response study using the     same patient population. A biomarker of GC actions will make it possible to individualised     therapy during pharmacological GC treatment. It would allow GC replacement to be monitored in     Addison's disease and could become a specific diagnostic tool in patients with GC deficiency     and excess (Cushings syndrome).   "
86599|NCT02152540|"     This project will study 40 Veterans identified with symptoms understood to characterize mild     to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD).     Following screening and informed consent, Veterans will be randomly assigned to treatment     with repetitive Transcranial Magnetic Stimulation (rTMS) or sham rTMS (placebo). Additional     examinations will compare brain imaging (structural and functional MRI scans at rest) across     participants at baseline, after acute rTMS treatment, and at 6 month followup. The VA     population differs significantly from populations that have been included in prior trials of     rTMS for many conditions such as depression, chronic pain, and PTSD. Many returning Operation     Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) personnel and Veterans with concussion     histories report cognitive problems, such as impaired attention, verbal fluency, poor     planning, reduced working memory, and mental flexibility. The investigators hope to show the     efficacy and durability of rTMS in treating these symptoms safely in Veterans with     co-morbidities.   "
86737|NCT02150733|"     This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic     impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of     hepatic function, from normal to severely impaired.   "
86600|NCT02152527|"     Trimetazidine (1-[2,3,4-trimethoxybenzyl] piperazine dihydrochloride) is a clinically     effective antianginal agent. Despite these clinical successes, the understanding of     trimetazidine's mechanism of action remains incomplete, particularly influence of     trimetazidine on mitochondrial function in isolated human cardiomyocytes. The investigators     will perform this study to seek possible differences in mitochondrial respiration related to     standard preoperative enrolled trimetazidine therapy.   "
86601|NCT02152514|"     The purpose of the study is to determine if the administration of a mix of Sufentanil and     Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.   "
86602|NCT02152501|"     The purpose of this study is to research the effects of exercise on calories eaten and     expended. The investigator expects to find out whether subjects change their eating and     activity behaviors when starting an exercise program.   "
86614|NCT02152345|"     The main purpose of this study is to ﬁnd out whether treatment to prevent kidney rejection     with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result     in less delayed graft function or sleepy kidney after transplant than that seen in patients     who get tacrolimus as their main drug to prevent rejection instead of belatacept. The     investigators will also look at whether patients who get belatacept have the same, lesser or     more problems that those who get tacrolimus.   "
86615|NCT02152332|"     The purpose of this study is to evaluate the effects of JNJ-54861911 on the QT/QTc intervals     in healthy participants, when administered at therapeutic (50 milligram [mg] once-daily) and     supratherapeutic (150 mg once-daily) doses for 7 days.   "
86603|NCT02152488|"     Rotation or flexion of the cervical spine is unavoidable during positioning for some surgical     procedures as carotid endarterectomy, thyroidectomy and surgery of the shoulder. Rotation or     flexion may reduce blood flow in the carotid or vertebral arteries and induce intraoperative     cerebral ischemia with impact on the neurological outcome of surgery. Predominantly if the     circulus willisii is incomplete because of congenital variation, collateral arteries may not     be sufficient to compensate reduced blood flow in one carotid or vertebral artery. This may     be aggravated by intraoperative hypotension in limits tolerable under normal conditions but     fatal during impairment of vascular conductivity by positioning. The middle cerebral artery     (MCA) is a final large scale pathway of cerebral blood flow and hence relevant reduction of     flow in the MCA may serve as a surrogate parameter for relevant reduction of cerebral blood     flow caused by carotid stretching or narrowing.      Objective of this study is to investigate, if MCA blood flow in normal male and female     subjects, aged 18 to 85 years, is reduced in extended and rotated cervical spine position in     comparison to neutral position.   "
86604|NCT02152475|"     Photodynamic therapy (PDT) is a technique used for the oral disinfection. In dentistry, PDT     for microbial inactivation may reduces both dental plaque and risk of developing caries as     well as contributes to treat gingivitis, periodontitis, peri-implantitis and endodontic     diseases. The investigators hypothesis was that PDT with blue light and curcumin promotes     oral disinfection during 2 hours after treatment.   "
86605|NCT02152462|"     Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to     a control group. The investigators will randomize Black sedentary overweight/obese women to     Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will     come to the Georgetown community-based exercise facility 3 days/wk. The control group will be     asked to maintain their current daily activities and not to exercise for the duration of the     study. Based on the investigators previous findings that women who engage in 75-150 mins/wk     of brisk walking had an 18% decreased risk of breast cancer, the investigators will target     this level of activity in the investigators intervention arm. Also, this 150 min/week of     physical activity meets the current recommendations of the American College of Sports     Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals     and is in line with recommendation of the American Cancer Society (ACS) for cancer     prevention.   "
86606|NCT02152449|"     The purpose of this study is to determine whether an early oral nutritional supplementation     (ONS) in amyotrophic lateral sclerosis (ALS) patients is effective on the treatment of this     rapidly progressive disease.   "
86607|NCT02152436|"     Communication in the operating room (OR) is a key factor to prevent deleterious events for     the patient. French national health authority made the implementation of safety checklist     mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key     elements for better patient outcomes. Observational studies in the OR showed low compliance     to this checklist, either on the way it is used or on the information implemented.      The primary objective of this project is to assess the efficacy of a simulation-based     curriculum involving OR medical and non-medical personnel in order to improve communication     in the OR.   "
86608|NCT02152423|"     Because of their anti-Xa and ease of administration activity, the Low molecular weight     heparin represent an attractive alternative to the unfractionated heparin. Several clinical     trials have demonstrated that Low molecular weight heparin was more effective than     Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the     most studied. Its use is recommended.      Demonstrate that Enoxamed® is comparable to that of Lovenox® in the anti-Xa activity action.   "
86609|NCT02152410|"     Renal colics are a common cause af acute intense pain in medical emergency settings requiring     often the use of high level antalgics (opioid) to relief the patient.      In the other hand, Acupuncture is well known widely for its therapeutic characteristics,     especially in relieving pain.      the aim of these study is to compare this two pain relieving techniques in patients     consulting the emergency departement (ED) for acute onset renal colics.   "
86640|NCT02152007|"     A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in     adults with PC. Subjects may receive either placebo or treatment with at least 1 foot     receiving topical sirolimus at some time. For certain phases of the study treatment     assignment to the right and left foot will be randomized in a double blind fashion. Blood     levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be     taken through the 39-week study duration. Funding Source - FDA OOPD   "
86641|NCT02151994|"     The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after     single and multiple oral doses   "
86610|NCT02152397|"     Use of opioid medications for treatment of pain has increased greatly in the U.S., with the     average quantity of prescribed opioids increasing 700% in a decade, from ~100 morphine     milligram equivalents (MME) per person to ~700 MME per person from 1997 to 2007. There have     been concurrent increases in opioid-related adverse outcomes, such as extramedical use,     opioid use disorders, and overdose. As a result, there were more unintentional poisoning     deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640).     Additionally, the number of Americans seeking treatment for opioid use disorders has     increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary     substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530%     increase.      The specific aims of this project are to: (1) Refine a motivational enhancement prevention     intervention for prescription opioid overdose risk reduction and improved witnessed overdose     response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized     controlled trial comparing the prescription opioid overdose prevention intervention to a     supportive educational control condition for patients in addictions treatment in order to:     (a) obtain information about the feasibility of randomized controlled procedures; and (b)     determine the distribution and variability of the primary (overdose risk behaviors) and     mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk,     knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the     distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection     of prescription opioids) over follow-up.   "
86611|NCT02152384|"     This study will look into how a base dose of insulin peglispro and insulin glargine will     affect the meal time dose and efficacy of insulin lispro in type 1 diabetics. This study is     expected to last up to 17 weeks.   "
86612|NCT02152371|"     The main purpose of this study is to evaluate the use of the study drug known as dulaglutide     in participants with type II diabetes who are taking once-daily insulin glargine. The study     will last about 31 weeks for each participant.   "
86613|NCT02152358|"     The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV     viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of     ventilator-free days at Day 60.   "
86616|NCT02152319|"     The objective is to clinically assess the Kinesia HomeView system for automated and remote     monitoring of Parkinson's disease (PD) motor symptoms.   "
86619|NCT02152280|"     Research topic.        -  A clinical trial of Danhong injection in treating acute ischemic stroke .      Research purpose.      - To evaluate the efficacy and safety of Danhong injection in treating acute ischemic stroke     by a randomized, double-blind, multi-center, placebo-controlled clinical trial.      Research design.      - A randomized, double-blind, multi-center, placebo-controlled clinical trial.      Subject crowd.      - Accord with standard of western medicine diagnosis of acute cerebral infarction, stroke and     blood stasis type of traditional Chinese medicine syndrome differentiation.      Sample size. - Total sample size of 320 patients, experimental group, control group is equal     to 1 to 1.      Interim analysis.      - Interim analysis will be performed when the total number of included patients up to half of     the sample size ,160 cases, and according to the interim analysis results to estimate the     sample size and adjust the project adaptively.      Course of treatment.      - 10 days.      Research endpoint.      - The 90th day after the medication for the first time.      Observation index.        1. General condition; the physical and chemical inspection related;        2. Efficacy check : mRS, BI, NIHSS;        3. Safety check: blood routine, urine routine, stool OB, liver function(ALT、AST), renal          function (BUN, Cr), coagulation four indices（PT、APTT、TT、FIB), electrocardiogram.      Efficacy evaluation. 1. The main efficacy index: a. Percentage comparisons of two group     patients of modified Rankin 0-2 grades on the 90th day.      Statistical analysis technique.      - Statistical analysis using SAS 9.2 system, all the statistical test adopted bilateral     inspection, P value less than or equal to 0.05 will be considered a statistically significant     difference.   "
86620|NCT02152267|"     1. BACKGROUND: Temporomandibular Disorders (TMD) have become part of the daily routine of          all the health care professionals. Some studies have shown improvement in subjects with          chronic pain using neuromodulation. Chronic pain is involved with neuronal excitability          and the excitatory modulation is also being studied to treat chronic pain. Transcranial          direct current stimulation (tDCS) allows the neuronal membranes to be neuromodulated.          tDCS can enhance or inhibit the potential actions on the cortex. Studies with animals          has shown that anodal stimulation modulate the membrane in the way to depolarize which          results in a long term potential in the stimulated area.        2. PROBLEM: Most strategies for the treatment of TMDs are local and aim to treat directly          the cranial-facial muscles, applying kinesitherapy on Temporomandibular joint (TMJ)          and/or on the jaws and on the occlusion of teeth. Some drugs, such as tricyclic          antidepressants, that act in the CNS are used in these patients with positive results in          the beginning of the treatment. However, many patients after using these drugs in a          daily basis, are refractory to them and do not present an improvement in the pain          anymore or present several side-effects. Therefore, the investigators want to know if          tDCS over dorsolateral prefrontal cortex (DLPFC) would have an analgesic effect when          reaching emotional areas.        3. HYPOTHESIS: The investigators believe that neuromodulation by tDCS over DLPFC would          decrease the anxiety level and consequently the muscular hyperactivity that is an          important etiological factor of TMD. For that, the masseter motor evoked potential (MEP)          will be used to verify any change.        4. AIM: To investigate if cathodal tDCS over right DLPFC has analgesic effects in subjects          with muscular TMD.        5. METHOD: The investigators will run a three-arm crossover double blind with 15 muscular          TMD subjects. The group treatments will be cathodal tDCS 1mA, cathodal tDCS 2mA and          Placebo. To verify selection criteria the investigators will use RDC/TMD, Visual          analogical scale (VAS) score from 4 to 10 for six months or longer, Inventory of          state-trit anxiety (ISTA) score more than 42. The outcomes will be VAS, sensory testing,          Electroencephalogram (EEG) and ISTA.   "
86621|NCT02152254|"     The goal of this research study is to compare the effects of treatment based on molecular     profiling to those of the standard-of-care.      Treatment Assignment:      From a tumor biopsy, a molecular profile of the disease is established. Based on genetic     profiling, the following interventions will follow:      A) If there is no abnormality, patients will be treated according to the patient's doctor as     to what is in their best interest.      B) If there is an abnormality and there is an FDA-approved drug for the tumor type, patients     will be offered that treatment.      C) If there is an abnormality and there is no FDA-approved drug for the abnormality and the     tumor type, patients will be randomly assigned to Arm A (targeted therapy) or Arm B     (standard-of-care therapy).   "
86642|NCT02151981|"     A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet     Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer     whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase     Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth     Factor Receptor Gene   "
86622|NCT02152241|"     Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a     chronic course with remission and relapses. Canada is one of the countries with the highest     prevalence and incidence rates of IBD with 25% of patients present in children and     adolescents.      As with any chronic illness, IBD diagnosed early in life has a significant impact on the     physical, emotional and social development of those affected. Consequently, it is logical to     speculate that patients with IBD may not do as well in education levels or employment status     attained compared to their peers without IBD. If this were the case, then interventions could     begin in childhood to better prepare patients with IBD for the challenges of living with a     chronic disease. Alternatively, if it is shown that they reach comparable social or     employment milestones as adults compared to unaffected peers then this would be enormously     reassuring to children and their parents.      Properly designed studies to help in defining more appropriate interventions to these     patients are needed.      The proposed study includes circulating a survey to evaluate the functioning level of adult     patients with IBD who were diagnosed during their childhood. The participants will be asked a     series of questions regarding their highest level of educational achievement, the nature of     their current employment, and their current marital status. The question format will parallel     that of the Canadian Community Health Survey from which data from an age matched healthy     adult Manitobans will be extracted and used as another control group. Responses will be     analysed for any possible differences between these groups.   "
86623|NCT02152228|"     This is an observational, international, open label, pilot study to evaluate the safety,     tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult     hypoparathyroid volunteers.   "
86624|NCT02152215|"     The purpose of this study is to compare the clinical and histologic outcomes for acellular     dermal matrix and resorbable membranes to determine if either provides a significant     therapeutic advantage.   "
86625|NCT02152202|"     Our main objective is to perform an explanatory, first stage proof of concept, randomized     controlled trial to determine whether a semi-upright patient position versus a supine     position while asleep in the postoperative period helps decrease the worsening of AHI in     patients diagnosed with OSA and compare this to usual care (i.e. supine patient positioning     while asleep).      The investigators will evaluate whether a semi-upright position reduces: worsening of AHI (as     measured with a portable PSG) on the second postoperative night (POD2); oxygen desaturation     index (using a portable oxygen saturation monitor, oxygen desaturation defined as >4% change     below baseline lasting for 10 seconds); REM sleep related change in AHI at baseline and     POD2.; major and minor perioperative complications on postoperative day POD1, POD2, at     discharge and POD 30.; length of hospital stay and readmission within 30 days; and patient     satisfaction score on POD30   "
86627|NCT02152176|"     Intense acute pain is a common reason for Emergency admittance and its management is one of     the major public health goals.      In the recommendations formalized experts, it is recommended to use a protocol titration with     morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg)     repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.      Despite these specific recommendations and a broad awareness of the teams, management of pain     remains to be improved, the major difficulty of morphine titration at the emergency     department being the availability of paramedical personnel to perform revaluations and     reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.      The investigators want to study the self-controlled morphine titration by the patient by a     mechanical device for single use (efficacy/safety).   "
86628|NCT02152163|"     STUDY OBJECTIVES:        1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in          decreasing pain in orthopedic trauma patients with fractures of the extremities, face,          pelvis and/or ribs compared to patients not receiving the medication.        2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in          decreasing the use of opioid analgesics among orthopedic trauma patients with fractures          of the extremities, face, pelvis, and/or ribs compared to compared to patients not          receiving the medication.   "
86629|NCT02152150|"     The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet     in improving iron status in adolescents in India.   "
86630|NCT02152137|"     This phase II trial studies how well inolitazone dihydrochloride (efatutazone     dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that     has spread to other places in the body and usually cannot be cured or controlled with     treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading.   "
86631|NCT02152124|"     Acromegaly is a rare hormonal disorder leading to increased morbidity and mortality. In the     vast majority of cases, a pituitary somatotroph cell adenoma causes excess growth hormone     (GH) secretion, leading to hepatic insulin-like-growth factor 1 (IGF-1) hypersecretion. Both     the disease as well as its treatment with long-acting somatostatin analogs (LA-SMSA) and/or     pegvisomant affect glucose and lipid metabolism, possibly contributing to increased     cardiovascular risk.      In this pilot study, the investigators want to explore insulin sensitivity, postprandial gut     hormone response, lipid handling and adipocytokine profile in the following 4 groups:        -  controlled acromegalic patients on LA-SMSA (group 1)        -  controlled acromegalic patients on combination treatment of LA-SMSA and pegvisomant          (group 2)        -  acromegalic patients without need for medical therapy after surgery (group 3)        -  healthy control subjects (group 4)      Furthermore, a longitudinal exploration will be performed in uncontrolled acromegalic     patients (i.e. patients with serum IGF-1 levels above age-specific thresholds and/or symptoms     due to active acromegaly (excessive sweating , arthralgia)) on LA-SMSA monotherapy (group 5).     In this group, insulin sensitivity, postprandial gut hormone response, lipid handling and     adipocytokine profile will be explored before introducing pegvisomant and three months after     normalisation of IGF-1 levels.      The investigators hypothesize that lipid and glucose handling will be less efficient in the     controlled acromegalic patients on LA-SMSA than in controlled patients on combination therapy     or after surgery, and that there will be no difference in substrate metabolism between     healthy controls and controlled acromegalic patients on combination treatment or after     surgery. Further, they hypothesize that introducing pegvisomant in uncontrolled acromegalic     patients will improve their postprandial lipid and glucose handling.   "
86632|NCT02152111|"     This study aimed to evaluate the effect of weight loss with diet combined coconut flour     consumption improvement weight loss and reduction in glucose, cholesterol in obese women.   "
86688|NCT02151383|"     The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of an     intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients     with acute heart failure (AHF)   "
86738|NCT02150720|"     The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid     and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood     loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.   "
86633|NCT02152098|"     Firstly, the investigators aim to study the biochemical, structural and functional changes     associated with acute muscle strain injury in the acute phase and during rehabilitation in     vivo. Specific factors present after the injury and their effects on connective tissue cells     will be examined in vitro.      Secondly, the investigators will investigate individuals with chronic pain, scar tissue and     inferior function after a previous muscle strain injury and test a specific rehabilitation     program to alleviate pain and disabilities associated with the preceding muscle injury. The     investigators have the following hypotheses:        1. Humoral growth factors and pro-inflammatory macrophages released into the injured area          post strain injury stimulate formation of connective tissue in vitro.        2. Early onset of rehabilitation will be superior to a delayed start of rehabilitation for          the healing process, in regards to structural improvement of tissue and better clinical          function.        3. Scar tissue following a muscle strain injury is characterized by disorganized structure          of connective tissue.        4. Mechanical loading in the form of heavy eccentric muscle activity for 12 weeks will lead          to a local re-modeling of scar tissue, and result in improved function and reduced          symptoms in patients with chronic pain and impaired function after a previous muscle          injury.   "
86634|NCT02152085|"     The purpose of this study is to investigate the capacity of a 6-week treatment with     neuromuscular electrical stimulation to improve walking in individuals whose mobility has     been compromised by multiple sclerosis.   "
86635|NCT02152072|"     Dyspnea is a common symptom encountered frequently by medical practitioners. The differential     diagnosis for a patient with such a symptom is broad and time consuming, while immediate     management for distressed patients is what is desired. Lung ultrasound (LUS) is a relatively     new technique that will help physicians more accurately diagnose and manage patients who     present with dyspnea.      Focused medical ultrasonography education is becoming integrated into many physician     residency training programs. Recent studies indicate a possible relationship between focused     ultrasonography training in medical school curricula and improved physical examination     accuracy. Thus, a short-term training program in LUS during medical school will have a major     impact on physicians to be comfortable in using this skill when dealing with distressed     patients in their prospective residency training. It will reduce educational burdens for     physician residency programs and improve overall physician competency.      Simulation-based medical education (SBME) is ideally suited for offering effective training     in a zero-risk environment. It enables trainees to gain knowledge and confidence in dealing     with stressful clinical scenarios without exposing patients to any additional risk. SBME has     also been shown to be a reliable tool for assessing learners' procedural skills and for     teaching topics such as teamwork and communication.      The investigators hypothesize that simulation-based training of medical students will enable     them to more effectively evaluate patients with shortness of breath using LUS.   "
86757|NCT02150473|"     This study aims to compare longitudinally the effect of adalimumab plus methotrexate (MTX)     versus MTX monotherapy on cartilage GAG content, reflected by Delayed Gadolinium-enhanced     magnetic resonance imaging of cartilage (dGEMRIC) index, in patients with early progressive     rheumatoid arthritis (RA), who had not previously received any Disease modifying     antirheumatic drug (DMARD) or biologic treatment.   "
86636|NCT02152059|"     This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent,     platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be     more effective and better tolerated than standard therapy.      The purpose of this study is to:        -  Find out the proportion of patients with their small small cell lung cancer controlled          for at least 90 days after treatment with BIBF1120        -  Compare the response rate, survival and side effects of BIBF1120 in recurrent,          platinum-sensitive small cell lung cancer patients        -  Identify a group of patients who will benefit the most from BIBF1120 In this study,          patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21          days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if          patients do not tolerate it well or if the doctors are concerned about the side effects          of BIBF1120 on individual patients.   "
86637|NCT02152046|"     Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular     examinations of infants at risk for ROP are generally conducted between 4-6 weeks     postnatally. These exams are vital to protect preterm infants from blindness, but these exams     have been shown to cause pain in this population.      Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook     eyelid speculum. There is no schedule for who receives which speculum during their exam.      The objective of this study is to evaluate the pain response in the neonatal population, 32     weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for     retinopathy of prematurity (ROP) screening.      The primary study aim is to compare the N-PASS pain score between neonates who received a ROP     eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.   "
86638|NCT02152033|"     The purpose of this project is to develop and test a Home-based Continuing Care intervention     that will help parents support the recovery of their Young Adult (YA) child who is leaving     residential substance abuse treatment. The two phase pilot study will 1) interview 50 parents     and 50 YAs recruited from residential treatment programs and from parent groups to inform the     development of the intervention and 2) conduct a two-arm pilot study that will recruit a     maximum of 20 parents and their young adult children into one of two conditions (Home-based     Continuing Care [HCC] intervention group or Services as Usual [SAU] comparison group) with     the main goal of determining whether conducting such an intervention is acceptable and     sustainable, and to collect preliminary efficacy data. We hypothesize that pilot testing will     indicate that: (a) HCC is acceptable and potentially sustainable; (b) conducting a randomized     clinical trial is feasible, and (c) the magnitude of outcomes from HCC will be clinically     meaningful.   "
86639|NCT02152020|"     The objective of this study is to find out if acupuncture can improve the management of pain     in cancer patients when used as part of a treatment plan that includes conventional pain     medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and     Penn Cancer Network sites. Participants will be enrolled in either the Conventional Pain     Management group or Integrative Pain Management group.   "
86643|NCT02151968|"     Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block.     This is a blind technique where local anaesthetic is injected into the back of the eye to     make the eye numb and motionless for surgery. This is a blind injection and can be associated     with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure     of the eye etc. It also has a high failure rate resulting in need for additional injections,     further exposing the patient to possible complications. The investigators propose to perform     the peribulbar block with ultrasound to guide the block needle placement and injection. The     investigators hypothesize that ultrasound guided peribulbar blocks would have higher success     rate (less need for additional injections) and that the total amount of local anaesthetics     used would be decreased.   "
86644|NCT02151955|"     Following an exploratory project, funded by Guys and St Thomas' Charity between September     2010- November 2011, of the first combined mental health screening and intervention project     for <5 Children in Care (CiC) in the UK, the current study will expand this work by a)     developing a feasibility study to assess both longer term interventions and outcomes for this     group and b) extending the model to two further vulnerable groups of young children.      The three groups of children aged 3 months to 3 years (<4's) in Southwark include:        1. Children who become newly looked after (CiC)        2. Children of parents referred to Parental Mental Health team (PMH)        3. Children on Child Protection (CP) Plans      Parents will be invited to take part in the study if their children are eligible within the     groups above. Informed consent will be obtained at the outset.      Hypothesis;      The investigators aim to implement a method of screening that will identify socioemotional     and mental health needs in infants and young children, aged 0-3 years of age, across three     high risk cohorts (Children in Care, children on a Child Protection Plan, children of parents     with mental health difficulties).      Is it feasible to deliver an early treatment intervention that positively impacts on the     difficulties identified, by providing specific emotional, social and mental health support     and advice to the child's current caregivers in relation to the child.   "
86645|NCT02151942|"     The purpose of this study is to evaluate the procedural and clinical benefits of patient     specific pre-procedure rehearsal for operators with various experience levels as a tool for     optimizing Endovascular Aneurysm Repair (EVAR) procedures.   "
86646|NCT02151929|"     Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient     treated with primary PCI (pPCI).   "
86647|NCT02151916|"     The purpose of this study is to determine whether a combination of pre- and post-natal     preventive and behavioral interventions is effective in preventing early childhood caries in     Indigenous children.      Early childhood caries (ECC) causes profound suffering, frequently requiring expensive     treatment under a general anesthetic. It is associated with other chronic childhood     conditions such as otitis media and nutritional disorders, and is the strongest predictor of     poor oral health in adulthood. Despite ECC being entirely preventable, marked ECC disparities     exist between Indigenous and non-Indigenous children in Australia, New Zealand and Canada. If     the burden of ECC and associated oral health inequalities experienced by Indigenous children     in these nations are to be reduced, more needs to be done to ensure that appropriate     preventive measures, together with support for maintaining optimal oral health, are provided     to caregivers of such children in the early life stages. This will be an interventional     study, with all participants receiving the intervention benefits. Pregnant Indigenous women     residing in the three countries, their families and communities will be included. The     intervention will be implemented from birth and continue for the first three years of a     participating child's life. It will involve four components; dental care provided to the     mother during pregnancy, fluoride varnish applications for the child, oral health     anticipatory guidance and motivational interviewing. Following an Indigenous research     framework and methodology, the intervention will be tailored at the individual- or     family-level, with each caregiver or family progressing to the next level only when they are     ready. Developing a culturally-appropriate ECC intervention that aims to improve child oral     health, in full partnership with the Indigenous communities involved, will provide much     needed evidence for policy makers to address the challenge of improved oral health and     related outcomes for Indigenous children.   "
86648|NCT02151903|"     An open-label extension study enrolling patients experiencing clinical benefit following 6     cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology AO-101 study. Patients will be     permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of     administration they received while on the parent protocol. Prior pre-treatment (e.g.     Rituximab) will continue as before.   "
86649|NCT02151890|"     Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established     in 10 cases.      ESS cut off point for menstruation and pregnancy was 6.   "
86650|NCT02151877|"     Around 7500 neonates born yearly in the United States have complex congenital heart disease     that require surgical repair in the first few days of life. The complexity of the surgical     repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent     periods of low flow or complete circulatory arrest. The immature neonatal vital organs are     more prone to the complications of the cardiopulmonary bypass circulation, namely     ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide     (NO) is used frequently in neonates for the treatment of pulmonary hypertension,     Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R     injury and endothelial dysfunction.      The purpose of this pilot study is to assess the efficacy of NO administration via the CPB     circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in     neonates undergoing repair of complex congenital heart defects. Specific goals will be to     demonstrate that NO use via CPB will:        -  Decrease markers of I/R injury and systemic inflammatory response.        -  Decrease platelet activation leading to reduced postoperative bleeding and transfusion          requirements.        -  Decrease postoperative organ dysfunction, and hence decrease operative mortality and          postoperative morbidity.      Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the     CPB circuit, for the duration of surgery. They will be compared to a control group of 12     similar patients. Serum levels of different ischemic reperfusion injury and inflammatory     markers will be measured at different time points after surgery and will be correlated with     different end organ function tests and clinical course in the postoperative period. The     results will be compared between the two groups to try to determine the clinical benefit of     NO administration through CPB circuit.   "
86651|NCT02151864|"     The purpose of this study is to test the safety and determine the maximum safe dose of an     experimental drug called LDE225 (hedgehog inhibitor) in people with liver cancer. We have     identified hedgehog dysregulation as a novel mechanism for hepatocarcinogenesis and hepatic     fibrosis/cirrhosis. Therefore, we hypothesize that the hedgehog inhibitor may be an ideal     drug target for treating both hepatocellular carcinoma (HCC) and Child-Pugh A cirrhosis     (CPA).   "
86652|NCT02151851|"     This study will evaluate the safety & efficacy of Certolizumab Pegol (CZP) as additional     medication to Methotrexate (MTX) in Chinese subjects with Rheumatoid Arthritis. 400 patients     will be randomized to receive either CZP + MTX or placebo + MTX. Anticipated time in the     study is about 32 weeks.   "
86653|NCT02151838|"     To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for     the Prevention of Mother-To-Child Transmission of HIV (PMTCT)   "
86654|NCT02151825|"     The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the     gut microbiota composition, body composition and adiposity-related genes and metabolic     markers in healthy overweight adult subjects.   "
86655|NCT02151812|"     The primary objective of this study is determine the safety and performance of the Agent™     Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing     Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented     coronary arteries (in-stent restenosis).      The performance will be determined at six months post-procedure by quantitative coronary     angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA     results will be assessed by an independent, blinded angiographic core lab.      Study statistical hypothesis: The loss of in-stent luminal diameter at six months after     treatment of the restenosed stent with the Agent™ study device is not larger than the     respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is     non-inferior to the control device with respect to LLL.   "
86656|NCT02151799|"     The data regarding the effects of aesthetic body contouring is insufficient. Poor results may     related to preoperative psychological distress. Studies regarding eating disorder symptoms     are lacking. Therefore studies using standardized and validated are needed. We decided to     prospectively study quality of life, psychological distress, and eating disorder symptoms in     body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are     15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder     Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality     of life effects.   "
86657|NCT02151786|"     The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and     efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of     administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg) to     a large number of patients in daily medical practice.   "
86658|NCT02151773|"     The purpose of this survey is to assess the safety freeze-dried live attenuated measles and     rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated     measles and rubella combined vaccine Takeda) in terms of the occurrence of unknown/known     adverse drug reactions and factors that may influence the safety of vaccinees after the first     vaccination.   "
86659|NCT02151760|"     This study is being done to determine the safety, biodistribution, and radiation dosimetry of     18F-DCFPyL, and to detect prostate cancer by visual analysis.   "
86660|NCT02151747|"     Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger sequencing     is a standard method to identify BRCA 1/2 mutation. Next generation sequencing (NGS) is a     high-throughput parallel sequencing that can provide genetic information with high accuracy.     NGS is a faster and cost-effective method to detect gene mutations compared to Sanger     sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA 1/2     compared to Sanger sequencing.   "
86661|NCT02151734|"     This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel     group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients     with acute bronchitis.      The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically     non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the     treatment of acute bronchitis after 7 days.   "
86662|NCT02151721|"     -  Gefitinib is an orally active epidermal growth factor receptor-tyrosine kinase inhibitor          (EGFR-TKI). However, 20-30% of patients with EGFR-activating mutations show intrinsic          resistance to EGFR-TKI.        -  EGFR-mutant non-small cell lung cancer (NSCLC) cells with BIM (BCL2L11) deletion          polymorphism show the impaired generation of BIM with the proapoptotic BH3 domain, as          well as resistance to EGFR-TKI-induced apoptosis.        -  Both BIM polymorphism (12.9%) and EGFR mutations (50% in lung adenocarcinoma) are more          prevalent in the East Asian than in Caucasian populations. BIM is a BH3-only          proapoptotic member of the Bcl-2 protein family. BIM upregulation is required for          apoptosis induction by EGFR-TKI in EGFR-mutant NSCLC.        -  Vorinostat (suberoylanilide hydroxamic acid [SAHA]) is a small-molecule inhibitor of          histone deacetylase (HDAC) and induces cell differentiation, cell cycle arrest, and          apoptosis in several tumor cells. HDAC inhibition can epigenetically restore BIM          function and death sensitivity of EGFR-TKI in patients with EGFR-mutant NSCLC in whom          resistance to EGFR-TKI is associated with a common BIM polymorphism. EGFR-TKI resistance          due to the BIM polymorphism may be able to be circumvented in combination with HDAC          inhibition of vorinostat with gefitinib in NSCLC.   "
86663|NCT02151708|"     Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal     pain or discomfort in the absence of a specific structural cause.1 Several mechanisms have     been suggested to underlie dyspeptic symptoms. In a barostat study by Tack et al.2, impaired     gastric accommodation to a meal was found in 40% of patients with FD, and this abnormality     was associated with early satiety. Delayed gastric emptying (GE) was also found in almost 40%     of patients with FD, and was associated with the symptoms of postprandial fullness, vomiting     and early satiety.3-5 Improving gastric accommodation and prokinetic effect seem to be an     attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is     a new herbal drug that was launched in December 2011 in Korea for treating patients with FD.     It has multiple mechanisms of action such as fundus relaxation, visceral analgesia and     prokinetic effects.6 The current study aims to evaluate effects of motilitone on gastric     emptying and accommodation after a meal in patients with FD using three-dimensional gastric     volume measurements by magnetic resonance imaging (MRI). Patients are randomly allocated to     receive either motilitone 90 mg daily, motilitone 180 mg daily or placebo in a double blinded     manner. After 2 weeks of treatment, patients undergo gastric MRI. The primary endpoint is     gastric emptying rate. The secondary endpoints are gastric accommodation and symptom     improvement.   "
86664|NCT02151695|"     Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly     consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of     retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for     treatment of exudative age-related macular degeneration, another retinal disease     characterized by choroidal new vessels.      The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept     intravitreal injections compared to panretinal photocoagulation for proliferative diabetic     retinopathy.   "
92183|NCT02079467|"     The purpose of this study is to determine whether the form of rehabilitation following     primary total hip arthroplasty has an influence on patient satisfaction or functional     performance in the eighteen weeks following surgery.   "
86665|NCT02151682|"     Tapentadol has already been studied in adults. This study is needed to find out if tapentadol     works and is safe to use in children and adolescents with long-term pain.      During the first 2 weeks of the study (Part 1), participants will be given either tapentadol     or morphine prolonged-release tablets. Assignment will be done randomly (like tossing a     coin). The participant and the caregiver will know which medication they are taking. The     primary endpoint is based on data collected in Part 1 of this trial.      If eligible and willing, participants from Part 1 can enter a 12 month follow-up period (Part     2). In Part 2 of this trial participants will be treated with tapentadol prolonged release     tablets or with the standard of care (observation arm).   "
86666|NCT02151669|"     Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no     previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern     in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the     efficacy of a motivational smoking intervention based on information obtained by spirometry     (FIS project PI11/01962).   "
86667|NCT02151656|"     The purpose of this study is to evaluate the potential efficacy of oral F17464 in comparison     to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Study design:     double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multicentre     study.   "
86668|NCT02151643|"     The main purpose of this study is to see whether PT-20 can help people with a high level of     phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for     kidney disease.   "
86669|NCT02151630|"     Plantar warts can be bothersome and painful requiring treatment. The investigators will     compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts.     Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70% or     compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion     100%) applying topically twice a day for 4 weeks. Patients will be visited every 2 weeks for     one month after starting treatment and then every one month for up to 3 months. The number     and size of warts will be evaluated.   "
86670|NCT02151617|"     The purpose of this study in healthy people is to evaluate safety, toleration and time course     of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity     of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be     investigated.   "
86671|NCT02151604|"     Lung cancer is the second most commonly diagnosed cancer in the United Kingdom, accounting     for 22% of cancer deaths. The main treatments for lung cancer are surgery, radiotherapy or     chemoradiotherapy. Current methods, for assessing lung function in lung cancer patients i.e.     spirometry and gas transfer are inadequate. We aim to develop a new technique capable of     describing regional lung abnormality using hyperpolarized xenon gas MRI.      The study will involve 50 patients diagnosed with lung cancer considered suitable for radical     radiotherapy or chemoradiotherapy. Participants will be offered hyperpolarized Xe129 MR at     baseline, two weeks after commencement of radiotherapy schedules and four followup visits     over one year posttreatment.      Patients will undertake extensive study measures at baseline and followup visits, including     chest CT scans, ventilation/perfusion nuclear medicine scans, gadolinium enhanced MRI scans,     pulmonary function tests, breathlessness scores, radiotherapy induced lung toxicity     assessments and exercise testing. Participation in these full tests takes a day, allowing     patients time to rest between tests and allowing for a period of observation following the     final hyperpolarized xenon scan.      The investigators will correlate baseline hyperpolarized Xe129 MR imaging with spirometry and     breathlessness scores to determine if tolerance for radiotherapy is better predicted by     hyperpolarized Xe129 MR imaging. The investigators will evaluate changes in hyperpolarized     Xe129 MR imaging before and after radiotherapy (RT) to determine if it provides better     monitoring of response compared with spirometry.      The study will take place at the Churchill Hospital, Oxford University Hospitals National     Health Service Trust and will be funded by the National Institute for Health Research Oxford     Biomedical Research Centre. Hyperpolarized Xe129 MR imaging has the potential to inform     individual suitability for radiotherapy schedules better than the investigations used     currently. In addition, hyperpolarized Xe129 MR imaging has the potential for better     monitoring of treatment response and improved detection of radiation induced lung injury,     invaluable to treating patients with radiation induced injury.   "
86672|NCT02151591|"     The purpose of this study is to develop and test an integrated cognitive-behavioral     intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot     phase will be used to refine this protocol for the subsequent randomized, controlled pilot     phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a     12-week treatment phase in which participants receive varenicline (Chantix) and weekly,     personalized counseling.   "
86673|NCT02151578|"     A well-implemented community-based program of early and appropriate treatment of     fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction     of the less than five mortality rate.   "
86674|NCT02151565|"     Sciatica is a common pain problem that affects not only the patient but also constitutes a     socioeconomic burden and thus affects the whole society. So far, current pharmacologic     therapies are inadequate for many patients. Therefore, we evaluated application of high-tone     external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation     (TENS) on radicular pain associated with sciatica.   "
86675|NCT02151552|"     The purpose of this study is to learn more about the basic responses of the lungs to     inflammation using positron emission tomography, or PET, imaging scans of the lungs. PET is a     machine that detects radiation and generates pictures using a donut-shaped scanner similar in     appearance to an x-ray CAT or computed tomography (CT) scan or an MRI. Inflammation is the     way our bodies react to irritation or injury, and involves red, warm, and often painful     swelling of the affected tissue. An enzyme called inducible nitric oxide synthase (iNOS)     contributes to the development of lung inflammation.   "
86676|NCT02151539|"     This research trial studies medical chart review in determining outcomes of second-line     therapy in patients with acute graft-versus-host disease previously treated with     extracorporeal photopheresis or other systemic therapies. Gathering information about     second-line therapy in patients with acute graft-versus-host disease may help doctors learn     more about the disease and find better treatment.   "
86677|NCT02151526|"     This is a Phase 1/2, open label, safety, and efficacy study of the administration of     LentiGlobin BB305 Drug Product to subjects with either beta-thalassemia major or severe     sickle cell disease (SCD).   "
86678|NCT02151513|"     The purpose of this study is to examine the changes in immune function, as measured by     biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid medications     for the treatment of moderate to severe cancer pain.      Hypothesis: Treatment of pain with intrathecal (spinal) therapy is associated with little     alteration of immune function as measured by biomarkers in the blood of cancer patients with     moderate to severe pain.   "
93295|NCT02064907|"     The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of     dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue     and swallowed without water.   "
86679|NCT02151500|"     The goal of this study is to test the feasibility and acceptability of providing an     experiential assessment interview that targets emotional and stressful experiences in primary     care. In this randomized, controlled trial, the investigators will compare an interview     condition to a wait-list control condition. The investigators hypothesize that helping     individuals first identify the links between their stress and symptoms will likely increase     their awareness and endorsement of the link between stress and physical symptoms, including a     willingness to engage in stress management techniques. It is also expected that helping raise     an individual's awareness about their symptoms, followed by an experience and expression of     unexpressed emotions is likely to influence their physical symptoms and psychological status.   "
86680|NCT02151487|"     The aim of this randomized, observer-blinded clinical trial is to evaluate the anesthetic and     analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular     nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to     ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared     with ropivacaine alone.   "
86681|NCT02151474|"     The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986,     in subjects with moderate to severe rheumatoid arthritis.   "
86682|NCT02151461|"     The goal of this study is to demonstrate that leucine in combination with a low does of     metformin can serve as an adjunct to diet and exercise to improve blood glucose levels in     type 2 diabetic subjects. This study will compare three doses of a leucine-metformin     combination to the standard metformin dose in controlling blood glucose levels in type 2     diabetic patients.   "
86704|NCT02151162|"     The study is to explore the effectiveness of omega-3 fatty acids and mindfulness-based stress     management program to maintain healthy mental state in hospital nurses. The participants will     be junior nurses who work in inpatient wards and are not clinically depressed. The     participants will be randomly allocated to four intervention arms: 1) Mindfulness-based     stress management program plus omega-3 fatty acids pills ; 2) Mindfulness-based stress     management program plus placebo pills; 3) Psychoeducation leaflet plus omega-3 fatty acids     pills; and 4) Psychoeducation leaflet plus placebo pills. Thirty participants will be     allocated to each arm. These interventions will terminate until three months from     registration for each participant.      Information about depression and anxiety symptoms (primary outcome), insomnia, burnout,     presenteeism, quality of life, sick leave, consultation about mental state of herself, and     oxidative stress will be collected at 3 months, 6 months (primary time point) and 12 months     from registration for each participant.   "
86683|NCT02151448|"     This trial is to determine the safest dose of a triple combination (chemokine modulatory     regimen or CKM) of celecoxib, interferon alfa (IFN), and rintatolimod that can be given with     a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery.      The first phase of this study will determine the safest dose of IFN that can be given in     combination with celecoxib and rintatolimod along with a DC vaccine. The doses of celecoxib     (400 mg) and rintatolimod (200 mg) will be consistent while the dose of IFN will be increased     (5, 10, or 20 MU/m2) as participants are enrolled to the trial. The high dose of IFN in     combination with celecoxib and rintatolimod will be used for the next phase of the clinical     trial. After surgery, participants will receive 2 cycles of the investigational treatment.      The second phase of this study will test if the investigational treatment has any effects on     peritoneal surface malignancies. The doses of the combination determined in the first phase     will be used in this phase of the clinical trial. After surgery, participants will receive 2     cycles of the investigational treatment, followed by standard chemotherapy as determined by     their oncologist, and then 2 more cycles of the investigational treatment.   "
86684|NCT02151435|"     Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung.     The estimated prevalence is 30-80/100,000 in the United States with incidence estimates     clearly rising. A major challenge in the care of patients with IPF is determining prognosis.     The natural history of IPF is usually one of inexorable decline in lung function, ultimately     resulting in death from respiratory failure. However, longitudinal physiologic decline in IPF     is heterogeneous and difficult to predict in individual patients. While some patients with     IPF may remain stable for years, in others the disease may progress rapidly over a relatively     short time. We hypothesize that peripheral blood biomarkers based on extracellular matrix and     matrix-modifying molecules will improve prognostication in patients with IPF.   "
86685|NCT02151422|"     Despite the advances in pharmacological therapy for asthma, there has been an increasing     worldwide interest in alternative therapies for asthma. Treatments and therapies such as     yoga, acupuncture, homeopathy, hypnosis and Buteyko and other breathing techniques have been     used as complementary therapies however little evidence exists behind such practices.      Data from systemic reviews and randomized control trials provide evidence of benefit although     additional confirmation is still needed. Among the most common techniques are the Buteyko     breathing exercises that aim to reduce minute ventilation by instruct asthmatics patients to     breathe shallowly and slowly through the nose. The second common technique is the Pranayama,     or yoga breathing exercises which emphasizes deep respirations and exhalation prolongation.      Our goal is to assess the effectiveness of breathing exercises as a complementary therapy for     asthma.   "
86686|NCT02151409|"     This trial is conducted in Europe. The aim of this trial is to develop a complement system     targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic     autoimmune diseases.   "
86687|NCT02151396|"     There is evidence both that computer-administered cognitive training can improve ADHD working     memory deficits and that this type of training in non-ADHD enhances normal working memory     ability by altering brain activity in prefrontal cortex and the parietal lobe. However, no     study has characterized brain activity changes following working memory training in ADHD to     understand what neural changes occur when cognitive deficits are remedied. This R21     exploratory study will examine the neural basis of cognitive training treatment gains in     working memory, ADHD symptoms, and various other executive abilities. We will test the     hypothesis that working memory training increases frontoparietal brain activation and examine     other regions to see if there is any evidence for neural compensation (i.e., engagement of     brain regions after training that are not normally recruited for task performance).   "
86690|NCT02151357|"     -  Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with          advanced solid tumor        -  Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit.        -  Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR)          defined as the proportion of patients who continuously receive treatment after Cycle 1          with a best overall response of complete response (CR) or partial response (PR).   "
86691|NCT02151344|"     H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose     of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca     influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying     intervals.   "
86692|NCT02151331|"     The overarching goal of this study is to build the most cost-effective adaptive     implementation intervention involving a site-level implementation intervention strategy:     Replicating Effective Programs (REP), and the augmentation of REP using either External     Facilitation or a combination of an External and Internal Facilitation to improve patient     outcomes and the uptake of an evidence-based program for mood disorders (Life Goals-LG) in     community settings.   "
86693|NCT02151318|"     In this study, the investigators will collect tissue from patients undergoing trabeculectomy     for primary open-angle glaucoma treatment. This tissue would normally be discarded. These     trabecular meshwork (TM) cells can be cultured and used experimentally to better understand     the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the     trabeculectomy using established techniques.   "
86694|NCT02151305|"     We investigated the hemostatic differences according to the main anesthetic agents by     analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based     anesthesia would impair postoperative coagulability more than the sevoflurane-based     anesthesia.   "
86705|NCT02151149|"     Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subject     (≥ 70 years old) with advanced NSCLC   "
86695|NCT02151279|"     Chitosan, the main component of the exoskeletons of crustaceans, mollusks and cephalopods,     has been used as a fining agent in wines. However, its safety among patients allergic to     shellfish has never been evaluated.      Adult patients followed at the Allergy and Clinical Immunology Department who have been     diagnosed with anaphylaxis to shrimp will be invited to participate in the study.      Clinical data will be collected to ascertain for eligibility and written information will be     provided. After signing informed consent, included subjects will perform skin prick-to-prick     tests (PTP) with shrimp boiling water condensate and with fined and unfined wines. All will     perform double blind oral challenge with the fined and unfined wines during 1visit day; the     placebo (unfined wine) and active challenge (fined wine with chitosan) will be separated by 2     hours. Challenge protocol will be performed with successive increasing doses administered in     4 steps at 15-minute intervals for a total of 100 mL. During the challenge signs and symptoms     will be monitored by a trained physician.      Results will be presented as negative or positive (defined by presence of symptoms and signs     of an allergic reaction).      Categorical data will be compared by chi-square test. P<0.05 will be considered statistically     significant.   "
86696|NCT02151266|"     Cognitive impairment (CI) is a prevalent problem in persons with HF heart failure (HF) and is     associated with adverse clinical outcomes, higher mortality and poorer quality of life.     Studies designed to attenuate or alleviate CI in persons with HF are limited, and evidenced     based guidelines for screening and provision of care are practically nonexistent. Improvement     in cognition has been reported following some therapies in HF and is thought to be the     consequence of enhanced cerebral perfusion and oxygenation, suggesting that CI may be     amenable to intervention in this population. Exercise is documented to increase cerebral     perfusion and oxygenation by promoting neuroplasticity and neurogenesis, and, in turn,     cognitive functioning. Brain derived neurotrophic factor (BDNF) is a key mechanism underlying     the effect of exercise, but most studies of BDNF have not included individuals with CI or     chronic illness populations, and its relationship to cognitive outcomes in HF is unknown.     Cognitive retraining techniques, originally developed to treat traumatic brain injury, have     also shown efficacy in broader neurologically-affected conditions and may provide added     benefit to that of exercise. Animal studies suggest exercise and plasticity-based cognitive     training could act synergistically through different neural mechanisms to have a more     pronounced and positive impact on cognitive outcomes than either approach alone; but this has     not been previously tested as an intervention to improve CI. The proposed feasibility study     is designed to test the acceptability and limited efficacy of a combined exercise (Ex) and     cognitive training (CT) program to improve CI in stable NYHA class II and III HF patients     compared to either exercise alone or a no-intervention, attention-control group. Findings     will be used to support the development of a future, large scale study to test the efficacy     of this intervention to improve cognitive functioning, quality of life, and physiological     markers of improved brain function in HF. In addition, we have an optional sub-study that     participants may participate in order to further our understanding of biomarkers of     inflammation and gen e expression before and after exercise.   "
86697|NCT02151253|"     The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a     means of improving residual daytime sleepiness in patients with treated nocturia.   "
86698|NCT02151240|"     The purpose of this study is to evaluate the efficacy and safety of Foscarnet Sodium and     Sodium Chloride Injection in patients with herpes zoster, and observe incidence of     Postherpetic neuralgia   "
86699|NCT02151227|"     Magnesium is an essential mineral found in many foods; rich sources include whole grains,     green leafy vegetables, coffee, and legumes. Magnesium is a critical cofactor in >300     enzymatic reactions, including those related to energy metabolism. Reduced magnesium intake     and serum concentrations have been detected, both cross-sectionally and prospectively,in type     2 diabetes and insulin resistance, hypertension, dyslipidemia, and cardiovascular diseases.      Different studies have reported inadequate magnesium intake and low serum magnesium     concentrations may correlated also with metabolic syndrome, defined as a cluster of metabolic     disorders including obesity, hypertension, dyslipidemia and impaired glucose tolerance or     diabetes mellitus. Previous studies on this subject, however, reported contradicting results.     Some investigations reported inadequate magnesium intake and low serum magnesium     concentrations while others did not.      To our knowledge, the epidemiological evidence on the relation between dietary magnesium     intake and risk of metabolic syndrome has not yet been summarized.Therefore, the     investigators will perform a systematic review and dose-response meta-analysis to assess the     association between dietary and circulating magnesium level and risk of metabolic syndrome.   "
86881|NCT02148848|"     Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment.     Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern     regarding their effects on fracture healing process. Therefore, therapy is usually delayed     for a period of time. To the best of our knowledge, there is no scientific data to support     whether bisphosphonate treatment should be given immediately after the surgery or it should     be delayed.   "
86700|NCT02151214|"     In malnourished patients in the palliative phase of cancer, the question is raised of the     relevance of implementing artificial nutritional assistance instead of oral feeding when this     is possible.      Medical prescription and implementation of artificial nutrition at this stage of the illness     seem less governed by data acquired by science than by subjective reasons (related to     beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply     ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with     teams, the patient and his family and relatives.      And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition     in a palliative situation for patients presenting with a normal alimentary tract is poorly     understood. The discomfort and risks of central venous or nasogastric artificial nutrition     require that the benefits of artificial nutrition be proven. The nature of these benefits     relate first and foremost to the quality of life experienced by the patient in such a     context. Only a controlled randomized study may lead to an optimal palliative nutritional     management of undernutrition to be determined, and to inform the patient and his/her     relatives clearly in order for them to express their preferences.      We hypothesize that abstaining from artificial parenteral central venous nutrition and     associated hydration for nutritional purposes improves quality of life without significant     loss of survival compared to implementing artificial nutrition, when considered, in the     absence of any specific curative treatment in anorexic patients in the palliative phase of     cancer.      To test this hypothesis, we propose to carry out a multicenter, prospective, controlled,     randomized study in order to evaluate the efficacy of implementing parenteral nutrition     compared to abstaining from doing so on the quality of life of undernourished patients in the     palliative phase of cancer. The effect on overall survival and the nutritional parameters     will be evaluated.      The ALIM K trial will be carried out in 12 centres specializing in supportive and     onco-hematology care .   "
86701|NCT02151201|"     We evaluated the impact of viewing an educational video about influenza vaccination in     pregnancy just prior to a routine prenatal visit on vaccination health beliefs and     vaccination rate. We hypothesized that the video would positively impact both vaccination     health beliefs and vaccination rate compared to a control video.   "
86702|NCT02151188|"     This study hypothesizes that milk protein consumed together or shortly before a white rice or     white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic     responses.   "
86703|NCT02151175|"     We intend to use focused ultrasound to stimulate or suppress brain activity in patients with     epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or     suppression visible with functional MRI, and will not cause tissue damage.   "
86706|NCT02151136|"     The purpose of this study is to determine whether sugar water (TootSweet, 24% sucrose)     effectively reduces pain in children ages 12 to 36 months undergoing venipuncture, as     measured by pain scores and cry duration   "
86707|NCT02151123|"     The specific aim of the study is to determine the false negative rate of the Metabiomics     Colon Polyp and Colorectal Cancer Assay for Cancer.   "
86708|NCT02151110|"     Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920   "
86709|NCT02151097|"     This study will evaluate the feasibility of using intra-operative Cerenkov Luminescence     Imaging (CLI) of prostatectomy specimens to determine tumour margin status. The samples will     be imaged using the LightPathTM Imaging System which consists of a light-tight box containing     an ultra-sensitive lens and radiation-shielded camera. This study will measure the     correlation between margin status of the WLE specimen and the metastatic status of dissected     lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a     pilot study to assess feasibility before proceeding to a pivotal study to evaluate the     benefits of the LightPathTM system in clinical practice.   "
86710|NCT02151084|"     This is a phase II study (the second stage of testing a new drug or new drug combinations) to     see how useful two different schedules of study drug selumetinib with cisplatin and     gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer.      Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK     1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other     types of human cancers. Selumetinib has also been shown to shrink tumours when given in     combination with cisplatin and gemcitabine in research studies done in animals and in some     patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work     by damaging DNA in tumor cells so that they are unable to grow and divide.   "
86711|NCT02151071|"     This study will correlate the resection margin status of the breast cancer tumour (WLE     specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary     lymph nodes as determined by EnLight, LightPath, and histopathology. This is a pilot study to     assess feasibility before proceeding to a pivotal study to evaluate the use of these imaging     systems in clinical practice.   "
86712|NCT02151058|"     The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth     rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days     compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest®     3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed     toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to     compare to brushing alone.      225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be     in this study will have an equal chance of being assigned to one of the three treatment     groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline     3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of     use). Volunteers will maintain a diary at home to record each treatment use. Examinations for     oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with     water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5,     which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).   "
86713|NCT02151045|"     In discal sciatica, after failure of medical treatment, the investigators propose frequently     a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently,     some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of     indications of this type of infiltration. An alternative would be to propose a lateral     epidural infiltration on contact with conflict.The objective of this study is to compare, in     112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target     posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control     versus an epidural infiltration of the same corticoid done in lateral on contact of disco     radicular conflict on scan control.   "
86714|NCT02151032|"     The goal of this research study is to compare how people who are 45-75 years old respond to 3     different versions of a program about screening tests for colorectal cancer. Researchers want     to use this study as part of a long-term project to learn the best ways to communicate health     information to patients.   "
86715|NCT02151019|"     The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D     Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for     locally advanced rectal cancer.   "
86716|NCT02151006|"     140 women with expected poor ovarian response undergoing IVF/ICSI will be randomly divided     into 2 groups using computer generated random numbers . Group 1 ( study group) will receive     DHEA 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI     cycle. Group 2 ( control group) will not receive DHEA. Patients included in the study will be     subjected to full history taking and clinical examination. On the second day of menstruation     serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count     (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of     follicles measuring 3-10mm.      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin     (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On     the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal     probe. Oocytes will be aspirated 34-36 hours after HCG administration. Oocytes will be     fertilized and embryos will be transferred. Both groups will be compared regarding the     proportion of pregnancy.   "
86717|NCT02150993|"     FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West     Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo).      ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks.      The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2     infected adult patients, in West Africa. A treatment will be considered as effective if more     than 55% of patients in that arm attain global success at 96 weeks.   "
86718|NCT02150980|"     Background: Worldwide, injuries from trauma represent a major public health problem. The     World Health Organization (WHO) has deemed this problem as one of the most important global     priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is     little empirical data in low and middle-income countries quantifying the burden of     musculoskeletal injuries.      Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The     primary objective of the study is to determine the mortality, re-operation and infection     rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS     study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and     Latin America.   "
86719|NCT02150967|"     This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor     activity in advanced or metastatic cholangiocarcinoma patients with FGFR genetic alterations.   "
86742|NCT02150668|"     Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed     childhood disorders, with prevalence rates estimated at 8%. Several of the primary symptoms     of ADHD relate to problems with temporal and materials organization (i.e. has difficulty     organizing tasks and activities, loses things, is forgetful, and fails to finish     school-work). In the school setting, problems with organization manifest as forgetting to     complete or losing homework assignments, difficulties planning for the completion of     long-term projects and studying for tests, and problems keeping class materials organized.     These organizational difficulties become particularly problematic in middle school and are     associated with low school grades and high parent and teacher ratings of academic impairment.     In fact, organization of homework materials is one of the strongest predictors of academic     performance in students with ADHD, above and beyond the impact of intelligence, school     services, and ADHD medication use, and mediates the relationship between symptoms of ADHD and     school grades.      Given the relationship between temporal and materials organization and poor school     performance, it is clear there is a need for interventions to address these difficulties. The     PI sought to address this need by completing an IES Goal 2 study to develop a school-based     intervention targeting organizational skills that was feasible for school mental health (SMH)     providers to implement. The Homework, Organization and Planning Skills (HOPS) intervention     was developed and refined based upon input from 20 school mental health (SMH) providers,     students with ADHD and their families. SMH providers implemented the HOPS intervention, rated     the intervention as highly user-friendly and feasible to implement, and demonstrated     excellent fidelity to intervention procedures. Students who received the HOPS intervention     made significant improvements in homework problems and organizational skills compared to a     waitlist control. The feasibility and fidelity data demonstrate that the intervention has     potential for widespread dissemination. Preliminary outcome data suggest that the     intervention may significantly improve the academic performance of students with ADHD.     However, the small sample size (N=23 HOPS & N=24 control) precludes firm conclusions about     efficacy and moderators and mediators of intervention response. Accordingly, the primary goal     of this Goal 3 study is to evaluate the efficacy of the HOPS intervention, which focuses     teaching students' organization and time-management skills, as compared to an intervention     targeting on-task behaviors during homework completion and efficiency of work completion, the     Homework Support Intervention (HSI), and to assess moderators and mediators of intervention     response.      Middle school students with ADHD (N=260) will be randomly assigned to receive the HOPS     intervention or the HSI intervention. Students in both groups will receive the same amount of     intervention in terms of duration and frequency of intervention sessions. Six cohorts of     students will be recruited for the project. Each cohort will consist of 22 students at each     of two schools (44 per cohort) who will be randomly assigned to each of the two conditions.     Objective measures of skills implementation, parent and teacher ratings of organization,     homework problems, and academic impairment, and school grades will be examined pre and post     intervention as well as at 8-week and 6-month follow-ups. Treatment fidelity and integrity     will be closely monitored. Moderator and mediator analyses will be used to answer important     questions about the types of students most likely to benefit from organizational skills     intervention and the key mechanisms of change that lead to improved academic performance.     This study has significant potential to improve the academic performance of students with     ADHD because the intervention was designed with SMH provider input and has clear potential     for widespread dissemination upon proof of efficacy.   "
86720|NCT02150954|"     The purpose of this research study is to compare induction of labor using a foley catheter     bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of     oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor     induction in patients whose cervix is not significantly dilated or thinned out (effaced).     Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's     contractions.   "
86721|NCT02150941|"     Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus,     stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding.     However, blood clots often make visualization difficult during endoscopy. The current     practice is to try to wash off and suction up these blood clots with the endoscope. However,     this is often not successful due to blood clots blocking the suction channel.      A new device has been approved by Health Canada that attaches to the endoscope and helps     prevent blockage. It is believed that this device will help doctors suck out blood clots and     potentially improve visualization, identification of the cause of bleeding, and possibly     health outcomes, although this has never been proven. The purpose of the this clinical trial     is to test whether the device works and whether it can help patients with this type of     bleeding.   "
86722|NCT02150928|"     The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18     to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli     asparaginase or pegaspargase.   "
86723|NCT02150915|"     The purpose of this study is to test whether the application of acupuncture alters the     mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of     discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses     of the neurodynamic test of nerve median in asymptomatic individuals   "
86724|NCT02150902|"     Atrial fibrillation (AF) is an abnormal heart rhythm in which the top chambers of the heart     beat very fast. AF catheter ablation is a known technique to convert heart rhythm from AF to     normal rhythm. The technique sends out electrical energy through a catheter (long thin round     solid tubes) to destroy the heart tissues in a focused area where AF is starting. This     technique is practiced at many hospitals, including the Heart Institute, and is not     experimental.      The AWARE study will compare two techniques of AF catheter ablation:        1. Ablation of tissues in wide circular bands around the opening of the pulmonary veins          (bring blood back from lungs) in the left upper chamber of the heart. A medicine called          adenosine will be given to unmask any incompletely ablated area. Additional ablations          will be given if required. This is standard procedure.        2. Same as above but adenosine will not be used. Instead, additional ablation of a second          circular band of tissues around the opening of the pulmonary veins will be given. This          additional ablation is not standard procedure and is considered experimental.      We want to see if adding more ablation sites will help maintain normal heart rhythm and     reduce the rate of return to AF. We will compare the occurrence of medical events and     complications between the two groups.      Identical supplies and equipment used in both techniques have been approved by Health Canada.     Adenosine is currently approved by Health Canada for the treatment and diagnosis of     arrhythmias.      342 participants from The University of Ottawa Heart Institute will be randomly assigned     similar to flipping a coin to treatment group 1 or group 2.      After the ablation, participants can expect to remain in hospital for up to about 4 days.     They will have study follow-up at the Heart Institute every 3 months for 1 to 3 years,     depending on when they enter the study.   "
86725|NCT02150889|"     The investigators are interested in how skeletal muscle processes fat and how this may affect     insulin resistance. This is an important question since insulin resistance predates and     predicts type 2 diabetes. The investigators are especially interested in learning about the     effects of weight and training on insulin resistance. The investigators will study people     before and after supervised aerobic or yoga training to identify differences in resting fat     and sugar metabolism which may lead to differences in insulin resistance. The investigators     will test these differences using stable isotopes, and the use of these stable isotopes is     experimental.      Overweight/Obese Group: Eight visits will be required at the University of Minnesota Clinical     Research Unit. Four visits will be done before training (screen and 3 pre-training visits), 1     visit during the training, and 3 post-training visits will be done. In between, the training     will take about 16 weeks and will be a supervised treadmill program.      Lean/Trained Group: Four visits will be required at the University of Minnesota Clinical     Research Unit (screen and 3 study visits).   "
86726|NCT02150876|"     Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over     first-generation DES with promising results on long-term adverse events. But the thicker     polymer and/or strut may hinder its deliverability. Complex procedures challenge stent     deliverability and stent delivery failure impacts clinical prognosis.      This registry aimed to assess the immediate performance of the third-generation Synergy     everolimus-eluting stent (sEES) and its 12-month clinical follow-up in an all-comer     population.   "
86727|NCT02150863|"     This project aims to treat field cancerization ( pre-skin cancers) in a manner that will     reduce the future pre-skin cancers and non-melanoma skin cancers in patients with significant     photodamage.      This is 3 year prospective, randomized, controlled comparison of a single treatment with     carbon dioxide laser resurfacing vs. carbon dioxide resurfacing plus autologous epidermal     skin graft from a non sun exposed site vs. control.      Thirty subjects will receive treatment with each of the modalities.      The primary measures of efficacy are (a) count of the number of actinic keratosis and non     melanoma skin cancers, (b) blinded evaluation of severity from standard digital photographs     taken before and after the treatments, and (c) change in histology before and after     treatment. Safety measures include (a) pain, (b) scarring, (c) wound healing, (d) and     infection   "
86728|NCT02150850|"     Bisphosphonates are recommended as first-line agents to reduce fracture risk in patients with     osteoporosis and have in general an excellent safety profile. However, recent reports have     noted that prolonged use of bisphosphonates may be associated with rare but serious adverse     effects, namely atypical femur fractures (AFF), an atraumatic subset of subtrochanteric and     diaphyseal fractures.      The overarching aim of this project is to contribute to the characterization of clinical,     biomechanical, radiological and genetic predictors of AFF, associated or not with     bisphosphonate and-or denosumab therapy. AFF arise on the lateral (external) aspect of the     subtrochanteric and diaphyseal regions of the femur, regions subjected to high mechanical     loads. Because of this unique distribution, the investigators hypothesis is that patients     with AFF demonstrate specific geometrical variations of their femur whereby baseline tensile     forces applied to the lateral cortex are higher and might favour the appearance of these rare     stress fractures. Measurements to investigate these geometric variations with be calculated     from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray     scanner.   "
86729|NCT02150837|"     The purpose of this study is to retrospectively and systematically review records of     overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to     the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for weight loss to gain a better understanding of     the effectiveness of these programs. The study will describe demographics of this population,     along with weight loss, anthropometrics, body composition and effects on available     cardiovascular parameters. Adherence to the plans will also be examined.      The study hypothesis is that the 5 & 2 & 2 Meal Replacement Plan and the 4 & 2 & 1 Meal     Replacement Plan are both effective programs for weight loss in overweight and obese adults.   "
86730|NCT02150824|"     Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with     type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable     metformin background treatment over 28 days. Assess the effect on fasting plasma glucose     after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI     187004.   "
86731|NCT02150811|"     The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in     patient with interstitial cystitis/bladder pain syndrome   "
86732|NCT02150798|"     The aim of the present study was to evaluate the effects of a high fat, low carbohydrate     (CHO) diet on clinical status during 60 days of follow-up in patients with stable heart     failure (HF).      In a randomized controlled clinical trial 44 ambulatory patients with HF were included,     assigned to an intervention (40% CHO, 40% fat and 20% protein; n=22) or control groups (50%     CHO, 30% fat, 20% protein; n=20). Both groups received recommended pharmacological     management. At baseline and at 2 months of follow-up, the variables evaluated were: body     composition, handgrip strength, oxygen saturation, dietary intake, clinical data, lipid     profile, plasma glucose and exercise tolerance   "
86733|NCT02150785|"     Currently, thrombolysis is offered to less than 1% of patients in low to middle income     countries (LMICs) where access to health care is often based on the financial capabilities of     the patient. There is therefore an urgent need for an effective but affordable alternative     thrombolytic agent. Streptokinase (SK) ($35) is much more economically feasible as opposed to     tissue plasminogen activator (tPA) ($2800). In this study, we propose a reevaluation of the     use of streptokinase (SK) in the treatment of acute ischemic stroke. We want to emphasize     that we will only consider this as a 'treatment option' if we are absolutely certain that IV     tissue plasminogen activator (tPA) will not be offered to the patient due to its high cost.     It is hypothesized that treatment with SK in appropriately selected patients will be     associated with a hemorrhagic transformation rate similar to that of tPA.   "
86734|NCT02150772|"     Background: The main goal when diagnosing thyroid nodules, is to differentiate the few     malignant from the overwhelming background of benign nodules. Currently available     pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic     thyroid surgery is necessary. Therefore, there is a need to develope the diagnostic tools for     pre-operative diagnostic work-up of thyroid nodules.      The study will investigate a novel ultrasonographic technique called Shear Wave Elastography     (SWE) in the pre-operative evaluation of thyroid nodules.      Aim:      To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in     a tertiary surgical center.      Perspectives:      An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can     reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the     economic and surgical resources.   "
86735|NCT02150759|"     -  Comparison study of analgesic effects for dexmedetomidine-fentanyl vs          dexmedetomidine-ketamine        -  lateral position for spinal anesthesia in femur proximal fracture patients   "
86736|NCT02150746|"     It is hypothesized that circulating tumor cells (CTCs) from pancreatic adenocarcinoma are     released into the peritoneal cavity through blood lost during the surgical resection of these     tumors resulting in peritoneal recurrence despite appropriate surgical resection. Targeting     the mechanisms responsible for CTC adhesion to the peritoneum may result in inhibition of     implantation and growth, thus preventing this mode of pancreatic cancer recurrence     postoperatively.   "
86739|NCT02150707|"     This study aims to determine if different diabetes treatments have different effects on     inflammation; in particular, kidney inflammation. This type of inflammation is common in     people with diabetes, and can lead to kidney failure. This study will investigate the effect     of different types of diabetes treatment on kidney inflammation. This will help us to decide     if certain types of medicine should be preferred in people with evidence of inflammation in     their kidneys, as this may help prevent major complications including kidney failure.   "
86740|NCT02150694|"     Apelins are substances which occur naturally in the body, and have an important role in heart     disease. They have been shown to make blood vessels dilate, and improve the way the heart     works.      The investigators have devised 2 sets of experiments to investigate how the apelins affect     blood vessels.      In the first group of experiments,the investigators will give healthy volunteers up to 3     different apelin substances, and use special research techniques to see how they affect the     way that blood vessels work in the forearm.      In the second group of experiments, the apelins will be given along with another form of     apelin which blocks the effects of apelin in laboratory experiments. The investigators want     to see if it blocks the effects of apelin in healthy humans.      The investigators intend to test the hypothesis that:      Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by     an apelin receptor antagonist.      This study will help us to understand more about how apelins work, and to suggest how they     might be used to treat heart disease.   "
86741|NCT02150681|"     This study will investigate the effectiveness of mindfulness-based cognitive therapy (MBCT)     for mood stabilization in perinatal women (preconception, pregnant, and postpartum) with a     history of mood disorders. MBCT is a short-term group psychotherapy that has shown     effectiveness in preventing depressive relapse. MBCT teaches mindfulness practices and     cognitive-behavioral techniques.   "
86743|NCT02150655|"     The overall objective of this clinical pilot study is to determine at a random sampling time,     the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial     vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects     could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins     will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and     infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the     ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a     healthy state and lower environmental toxins will be completed.   "
86744|NCT02150642|"     The investigators are interested in examining 1) the basic organization of spinal and     cortical circuitry for the control of movement and 2) the influence of injury of these     circuits. To investigate the neuronal circuitry, the investigators use various types of     mechanical or electrical stimulation of the limbs, transcranial magnetic stimulation of the     cortex and galvanic vestibular stimulation in both uninjured human subjects and subjects with     a neurological injury (such as spinal cord injury, or Parkinsons's disease).   "
86745|NCT02150629|"     The study aims at discerning specific gait patterns and elucidating locomotor control of     spinal cord injured patients in order to find sensitive kinematic and electromyographic     outcome measures that are able to reveal information on underlying mechanisms of normal and     aberrant gait control and its recovery over time. These measures may also be used to compare     the outcome across different neurological disorders.   "
86746|NCT02150616|"     The purpose of this study is to investigate the effect of travelling to moderate altitude and     of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of     patients with pulmonary hypertension or with interstitial lung disease.   "
86747|NCT02150603|"     The purpose of this study is to examine the differences in perceived health, psychosocial     functioning, behavioral outcomes and quality of life of adults with congenital heart disease     who are living in different areas of the world, and how these differences can be understood     (e.g., differences in sense of coherence or illness perceptions).   "
86748|NCT02150590|"     The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a     stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung     disease.   "
86749|NCT02150577|"     The objective of this Implementation Trial is to evaluate the implementation of evidence     based practices for Bipolar Disorder and Treatment Resistant Depression in small rural     Federally Qualified Health Centers. The evidence based practices chosen and adapted by Health     Center providers and patients in consultation with clinical experts include: screening for     and diagnosing Bipolar Disorder, prescribing mood stabilizers, on-line cognitive behavioral     therapy, on-line peer support, collaborative care management and tele-psychiatry     consultation. A quasi-experimental study design will be used, with each of the six     participating Federally Qualified Health Centers choosing one implementation clinic and one     control clinic. Implementation outcomes include: reach, adoption, implementation-fidelity and     effectiveness. Providers and patients may choose to use all, any or none of the evidence     based practices based on their needs and preferences. Data will be collected from chart     review and patient surveys will be administered by an Interactive Voice Response telephone     system.   "
86750|NCT02150564|"     Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand)     in improving the extent of resection in intra-axial brain tumors. All patients will undergo     resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the     standard arm, only navigation will be used. This study will help in assessing the usefulness     sononavigation in improving radicality of resection in malignant gliomas and also to access     the accuracy of SonoWand in predicting residue (histopathological correlation).   "
86751|NCT02150551|"     In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells     intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has     not responded to conventional therapies. The goals of this study are to test the safety and     tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease.      Mesenchymal stromal cells support the development of blood cells within the bone marrow. When     isolated from a donor and infused into an animal or human, they have been demonstrated to     travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory     cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection.     These properties lead investigators to hypothesize that that these may be they may be     beneficial in treating inflammatory bowel disease.   "
86752|NCT02150538|"     This study was designed to evaluate the potential benefits of treatment with biventricular     device in patients with normal systolic function , indication for pacing and impaired     atrio-ventricular conduction , by comparing the treatment with dual-chamber device . The REAL     -CRT study is designed to test the hypothesis that, in patients with atrioventricular block     of I degree and standard pacing indications , biventricular pacing is superior to single     stimulation of the right ventricle (RV) with optimized algorithms for minimization of pacing     , as assessed by echocardiography an endpoint defined in terms of maintenance over time of     left ventricular ejection fraction (LVEF ) and left ventricular end-systolic volume ( LVESV )     .   "
86753|NCT02150525|"     This randomized double-blind clinical trial studied the effect of oral omega-3 fatty acid on     atrophic vaginitis in postmenopausal breast cancer survivors (N=52). Omega-3 fatty acid may     reduce inflammation and improve vaginal symptoms in postmenopausal breast cancer survivors.   "
86754|NCT02150512|"     The purpose of this study, in mechanically ventilated septic shock patients, is to determine     whether a fluid loading strategy based on parameters derived from the transpulmonary     thermodilution technique may lead to more ventilator free days compared to a fluid loading     strategy based on the surviving sepsis guidelines.   "
86755|NCT02150499|"     This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects     birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's     office with an acute bronchospasm. Subjects presenting to the ED or physician's office with     an acute bronchospasm must have a history of reactive airways disease, based on subjects'     parent/guardian report.   "
86756|NCT02150486|"     To determine whether perioperative myocardial injury is associated with adverse outcome in     patients scheduled for major abdominal surgery.   "
86758|NCT02150460|"     The aim of the study was to compare the efficacy and safety of single injection peribulbar     anaesthesia against the classic double injection technique.      This was a double blind randomized controlled trial involving two groups of consenting, adult     Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the     subjects to the two groups administered all the injections. The same surgeon operated on all     the subjects while the principal investigator and a research assistant measured the outcome     variables. All others were blinded as to subject allocation.   "
86759|NCT02150447|"     The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric     cancer bleeding in inoperable patients.   "
86760|NCT02150434|"     The aim of the current study was to evaluate a new system (FreeO2) that automatically     titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic     obstructive pulmonary disease during exercise. The investigators hypothesized that continuous     automatic adjustment of the oxygen flows during exercise would better maintain patients     within the oxygenation target, reduce episodes of desaturation and hyperoxia and would     improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and     with compressed air breathing.   "
86761|NCT02150421|"     The aim of the stuy is to investigate the effects of the adoption of a curriculum with     electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their     changes in refractive error and visual function.   "
86762|NCT02150408|"     Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived     from the primitive gut and include digestive and bronchial NETs.      Historically, the gold standard in their functional exploration is the conventional     somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This     reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity     is moderate (60 %), because of its intrinsic detection limits, which could delay the     diagnosis or lead to inappropriate therapy.      The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68     (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has     improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS.     Furthermore, patient irradiation and imaging protocol are significantly reduced.   "
86763|NCT02150395|"     This study looks at the effects of a protocolized music therapy intervention on state anxiety     for patients with cancer undergoing simulation for radiation therapy. Simulation, which is an     imaging and diagnostic procedure, has been identified as producing significantly high levels     of anxiety in many cancer patients.   "
86764|NCT02150382|"     China Rural Hypertension Control (CRHC) Project is a cluster randomized trial aims to test     the effectiveness of a standardized protocol-based treatment program on hypertension control     in rural China.   "
86765|NCT02150369|"     -Purpose: Phase I: To test the methods, data collection and analysis in a study to evaluate     cognitive/affective/sleep symptoms in one patient undergoing treatment with high-dose     Interleukin-2 (IL-2) for metastatic renal cell carcinoma (RCC), their informal caregiver and     their primary nurse.      Phase II: A pilot study examining up to 10 IL-2 cases to describe cognitive/affective/sleep     symptoms of patients receiving high-dose IL-2 therapy for metastatic melanoma (MM) or     metastatic RCC in order to develop interventional studies to minimize these symptoms.      -Aims: In this pilot, a case is comprised of the metastatic RCC patient receiving IL-2, their     care partner, and their primary nurse. The care partner for this study will be the family     member or friend staying with the IL-2 patient throughout treatment.      Phase I (Evaluation of Methods and Procedures):      One case will be examined to evaluate the methods, data collection and analysis to be used in     this study. The aims of Phase I of this study are to: Aim 1) Evaluate recruitment and     enrollment procedures to enroll one IL-2 case, comprised of the IL-2 patient, their care     partner and their primary nurse; Aim 2) Evaluate administration procedures, data collected,     and analysis of four questionnaire scales to detect the trajectory of cognition [Attentional     Function Index and Montreal Cognitive Assessment] and affect [Hamilton Anxiety scale and     Inventory of Depressive Symptomatology‒Clinician] in the IL-2 patient from the start to the     end of a cycle of treatment; Aim 3) Evaluate procedures, data collected and analysis of     journal entries from the care partner who are to record their thoughts, observations, and     feelings concerning any changes in the patient's behavior or cognition during IL-2 treatment     every 8 hours; Aim 4) Evaluate procedures, data collected and analysis of semi-structured     questionnaires completed by the primary nurse taking care of the patient receiving IL-2 which     will describe any changes in behavior or cognition in the patient during their IL-2     treatment; and Aim 5) Evaluate procedures, data collected and analysis of data of interviews     with the IL-2 patient to further discern what symptoms endorsed on the measurement scales     represent and how they are characterized, and interviewing the primary nurse to gain any     additional data on cognitive/affective symptoms observed in the IL-2 patient.      Phase II (Investigating Cognitive, Affective and Sleep Alterations in Patients Receiving high     dose IL-2 therapy): Up to 10 additional cases will be enrolled to understand cognitive,     affective and sleep symptoms induced from IL-2 therapy in oncology patients with MM or     metastatic RCC, and help design future studies to ameliorate these treatment-limiting     symptoms. The specific aims of this study are to: Aim 1) Describe cognitive (language,     concentration, mental fatigue, confusion, attention, short-term memory, and orientation),     affective (depression, anxiety, mood alterations), and sleep disturbance symptoms in patients     receiving 1 to 4 cycles (up to 8-weeks) of high-dose IL-2 therapy. Aim 2) Examine observed     patient experiences of cognitive/affective/sleep symptoms from each patient's primary care     partner, and primary nurse during 1 to 4 cycles of IL-2 therapy. Aim 3) Describe the     trajectories of cognitive/affective/sleep symptoms in patients with MM or metastatic RCC     undergoing 1 to 4 cycles of IL-2 therapy. Not all patients will receive 4 cycles of IL-2,     because treatment will depend on a) disease progression and b) side effect toxicity;     therefore, the symptom trajectory will be described for the cycles completed in situations     where all cycles are not completed.   "
87845|NCT02136251|"     We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder     arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we     suggest that the absence of radiolucent lines will correlate with excellent shoulder     function.   "
86766|NCT02150356|"     Very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular risk     factors. Price et al.(2010) have shown that 4-week supplementation of aleurone-enriched     products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced     homocysteine and LDL-cholesterol levels. Interestingly, aleurone had no effect on total     antioxidant status or endothelial function, whereas an improvement of C-reactive protein was     observed (Price RK et al, 2012). It is not known whether consumption of more than 27g/day of     aleurone-enriched products with higher ferulic acid biodisponibility and longer time of     treatment could influence these parameters in individuals with metabolic syndrome.     Noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting     and postprandial glycemic homeostasis and lipid metabolism. In addition, mechanisms by which     aleurone may act in vivo are still unknown.      The aim of this study is to investigate whether 8 weeks supplementation with     aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones     levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese     subjects with high cardiovascular risk.   "
86767|NCT02150343|"     The purpose of this study is to compare the treatment effect of three treatment regimens of     HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue     medication usage, Quality of Life and Sleep Quality   "
86796|NCT02149966|"     This is a dose escalation study that will be conducted in healthy volunteers. Multiple     cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily     for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the     pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348     with specific biomarkers assessed in the blood.   "
86843|NCT02149342|"     This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and     methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using     randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12     months. Pain during and after treatments and adverse reactions at one week are recorded.   "
86768|NCT02150330|"     Diminished ovarian reserve (DOR) is one the challenge in the field of artificial reproductive     technology (ART) while there is still no effective resolution of this disorder. In patents     with DOR, the pregnancy rate is about only 2-4%. Eventually, patients with DOR turn to adapt     children instead. In recent studies, dehydroepiandrosterone (DHEAS) supplement might play a     role in reverse diminished ovarian reserve and improve the prognosis of ART. Cumulus cells,     formed cumulus-oocyte complex (COC) with oocyte, play a important role in folliculogenesis,     oocyte maturation, oocyte meiosis and ovulation. Growing evidences disclose there are     crosstalks between oocyte and cumulus cells as paracrine regulations. Aberration the     crosswalks between oocytes and cumulus cells would be associated with poor prognosis of     folliculogenesis and further pregnancy outcomes. In patients under ovarian hyper-stimulation     protocol, the assessment of cumulus cells might be reliable indicators of folliculogenesis,     embryo development, pregnancy rate and pregnancy outcomes. These genes (indicators), such as     Hyaluronan synthase（HAS2), Versican (VCAN), Thrombospondin 1 (THBS1), Runt-related     transcription factor 2 (RUNX2), Chromobox homolog 3 (CBX3),Tripartite motif-containing 28     (TRIM28), B-cell lymphoma 2 (BCL2)，BCL2-associated X protein (BAX). This study was assess the     gene expressions of cumulus cells after the DHEAS supplement in patients with DOR under     ovarian hyper stimulation protocol.   "
86769|NCT02150317|"     The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE)     followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.   "
86770|NCT02150304|"     postdural puncture headache is a rare but serious complication of spinal anesthesia. many     drugs were studied in prevention or treatment of that complication. However, there are     limited numbers of trials about intravenous aminophylline for prevention. because of that we     retrospectively aimed to investigate the effectiveness of aminophylline for postdural     puncture headache in cesarean section.   "
86771|NCT02150291|"     Since success of the combination therapy with PEG-IFN and RBV is contingent on maintaining     adequate doses of both drugs throughout the treatment period, the emergence of hematological     side effects is expected and requires intervention. The hematological adverse effects lead to     a trade-off between continuing the treatment with optimal dosage, to clear the virus,     exacerbating thereby the side effects versus decreasing dosage to relieve severe anemia,     reducing thereby the chances of achieving sustained virological response (SVR). Therefore, we     aimed at giving Folic acid® and Neurobion® to HCV-infected patients during treatment with     different types of PEG-IFN plus ribavirin in an attempt to evaluate its efficacy and safety     as a prophylactic treatment to prevent hematological adverse effects. Preventing adverse     effects without interfering with the therapeutic efficacy of different types of PEG-IFN plus     ribavirin in HCV patients will lead to better health outcomes and improvement in their     quality of life (HRQOL).   "
86772|NCT02150278|"     Objectives: The main objective of this pilot study is to assess the feasibility and     effectiveness of a brief intervention to reduce drinking-driving behavior.      Methods:      Design: Pilot multicentre before/after intervention study without control group.     Participants: We aim to recruit, from 01/01/2013 to 01/05/2013, 212 drivers aged 18 to 65 who     declared to have consumed alcohol previous to driving, at least once in the past 30 days.     Intervention: Brief behavioral intervention to reduce alcohol consumption before driving.     Outcomes: Frequency of driving under the influence of alcohol in the past 30 days, regular     alcohol consumption (Audit-C test), level of self-efficacy and stage of change according to     the Prochaska and DiClemente's Transtheoretical Model of Change, sociodemographic variables,     driver's profile, chronic pathologies, long -term medications, level of self risk perception.     Information will be checked against medical record. Information on a) frequency of driving     under the influence of alcohol in the past 30 days, b) regular alcohol and c) level of     self-efficacy and stet of change according Prochaska State will be gathered at one month and     12 month post intervention. Descriptive bivariate analysis to assess the distribution of risk     elements associated to drinking-driving behavior.      Potential impact expected: This pilot project will determine the feasibility of making a     brief advice intervention in drivers under the influence of alcohol in primary care.   "
92578|NCT02074319|"     The aim of the this study is to evaluate the effectiveness of methotrexate added to treatment     as usual on positive and negative symptoms, cognitive and social functioning and quality of     life of patients suffering from schizophrenia.   "
86773|NCT02150265|"     Background: There is need for more effectiveness studies concerning treatment of emotional     symptom problems indicating anxiety and depression in adolescents. SMART is the only     treatment manual for combined emotional disorders developed in Norwegian.      Purpose: To find the best individualized treatment for adolescents with emotional     difficulties by: Finding criteria for the selection of appropriate patients for treatment     with cognitive-behavior therapy program SMART in an outpatient population (14-18 years).     Finding predictors of completion of treatment program SMART. Examining the effects of     treatment with the SMART program at 6 months follow-up.      Design: A randomized controlled study in six outpatient clinics in the north of Norway. N=     160 referred adolescents (14-18 years) with score above 6 on the Emotional Problems scale of     the Strength and Difficulties Questionnaire (SDQ). Two thirds are treated according to the     SMART-manual immediately, while the waiting list control group is treated with SMART after     six weeks.      Hypothesis: The SMART treatment is an effective treatment for emotional symptom problems.      Publication: The results sought published internationally and nationally and will be     communicated to clinicians.   "
86797|NCT02149953|"     It is important that pregnant women eat an adequate amount of protein to ensure healthy     growth and development of the fetus. Amino acids are the building blocks of the body's     protein. Glycine is an amino acid that can be made in the body, but under certain metabolic     circumstances (e.g. pregnancy) the body's needs may be higher and thus glycine must be     obtained from the diet. Currently, it is not known how much glycine may be needed from the     diet during pregnancy. We plan to study dietary glycine requirements in healthy pregnant     women, during early and late gestation. We will do this using a modern, safe and quick     method.   "
86798|NCT02149940|"     Heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality     rates, as well as diminishing hospitalizations. Also, pharmacist collaboration has been shown     to have a beneficial impact on heart failure related outcomes. Regardless, a high residual     event rate is to be noted.      In our pilot study, we wished to document whether a clinical pharmacist could still play a     role in the heart failure management of an elderly inpatient heart failure population.   "
86774|NCT02150252|"     -  Clinical trial; Ischemic stroke; Bu-Yang-Huan-Wu Tang （BYHWT）; Gait parameter; Quality          of life Stroke is the third of ten causing death disease constantly, and it also is          third of consuming healthy insurance budget. There is 17,000 peoples disable due to          stroke every year in Taiwan. Although ischemic stroke patient may use t-PA intravenously          treatment within 3 hrs after stroke onset in modern medicine, and no others method may          effect to treat ischemic stroke patients, thus, the study about stroke is an important          issue. Bu-Yang- Huan-Wu Tang (BYHWT) has been became a main stream for the treatment of          stroke after Qing dynasty Wang Qing-Ren theory that is BYHWT may treat stroke due to          pattern of qi stagnation and blood stasis in traditional Chinese medicine. A number of          researches report that BYHWT can reduce blood viscosity, anti-inflammation, enhancing          neuronal regeneration and angiogenesis, but above-mentioned about BYHWT limit in the          level of animal study and the scientific evidence is insufficiency in human trial.          Therefore, the purpose of the present study was to investigate the therapeutic effect of          BYHWT treating ischemic stroke by using a strict clinical trial.        -  We designed a randomized, double blind, placebo-controlled study to assess the          therapeutic effect of BYHWT treating ischemic stroke. The study expects to finish the          assessment of 120 patients with ischemic stroke in three years. The study divided into:          1) control group, receive placebo-BYHWT 3.0 g TID every day for continuously 6 weeks          except ordinary medical care; 2) treatment group, the method is identical control group,          but receive BYHWY. The main outcome was according to the changes of gait parameter          including Speed, Cadence, Strike length, Gait cycle and Double support; and secondary          outcome including the changes of Functional independence measurement scores and Barthel          index scores, Ten Meters Walk Test, Short Physical Performance Batter, Berg Balance Test          and WHO quality of life-brief (Taiwan Brief).        -  We predict the results of the present can provide scientific evidence to proof BYHWT can          improve neurological deficit and also can improve quality of life in patients with          ischemic stroke.   "
86775|NCT02150239|"     Pain management is becoming an important ethical responsibility of the medical profession and     a focus of the health care system. However, there are limited literature evaluate the     postoperative pain experience and management in our local setting.   "
86776|NCT02150226|"     The objective of this work is to study in-mouth aging and LTD of monolithic zirconia     restorations. Microstructural changes characteristic of LTD processes, wear, and clinical     behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D     laser surface analysis will be used, directly on the restorations, which will be removed at     regular intervals.The working hypothesis is that LTD process is very slow at the scale at the     lifespan of dental prostheses.   "
86777|NCT02150213|"     To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study     CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).   "
86778|NCT02150200|"     Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000     hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The     percentage of hysterectomies performed laparoscopically is increasing. The advantage of     laparoscopy include fewer infections, less operative pain, faster recovery time and shorter     hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy     reduced to 3-4 days.      The study hypothesis is that a shorter postoperative stay does not decrease the quality of     life of the patients.      This study will compare the evolution of quality of life (with a questionnaire concerning     measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3     days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.   "
86779|NCT02150187|"     HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this     study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair     growth in men with tendencies for hair loss.   "
86780|NCT02150174|"     When people are tested on a previously learned material, they will latter remember it better     even when compared to a condition where they can re-study it. This phenomenon is called     retrieval practice and is supported by an extensive research literature mostly carried out in     normal students. This paradigm begins to be used in cognitive remediation programs in     patients suffering from memory difficulties.      The objective of this study is to investigate whether retrieval practice is spared in     patients with schizophrenia.      If effective, this method could be used in cognitive remediation programs.      Since episodic memory difficulties are supposed to be secondary to deficits in the     initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that     retrieval practice is spared in schizophrenia   "
86781|NCT02150161|"     The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared     to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of     postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.   "
86782|NCT02150148|"     Cancer survivorship has been claimed a national priority, with a call to develop effective     interventions that can prevent, delay, or mitigate the adverse effects and comorbidities in     this high risk population. Strong evidence exists that a healthful diet and regular physical     activity can prevent many chronic diseases and improve physical function. More research     however is needed to develop interventions that can produce long-term adherence to healthful     lifestyle behaviors. This pilot study is based on the hypothesis that vegetable gardening     interventions will be feasible and result in improvements in diet and exercise behaviors as     well as improvements in physical functioning and well-being.   "
86783|NCT02150135|"     Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality     of life have seriously deteriorated. There have been a few studies that showed an effect for     pain control by hyperthermia (heating the patient's body). However, there are several     limitations in conventional hyperthermia. In this study, the investigators tried to show the     effect of Oncothermia which is more selective to malignant tissue than conventional     hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.   "
86799|NCT02149927|"     In imaging functional connectivity (FC) analyses of the resting brain, alterations of FC     during unconsciousness have been reported. These results are in accordance to recent     electroencephalographic studies observing impaired top-down processing during anesthesia. In     this study, simultaneous records of functional magnetic resonance imaging (fMRI) and     electroencephalogram (EEG) were performed to investigate the causality of neural mechanisms     during sevoflurane anesthesia by correlating FC in fMRI and directional connectivity (DC) in     electroencephalogram.   "
86800|NCT02149914|"     Gastroesophageal reflux disease(GERD) mainly related to the reflux of stomach content induced     by the dysfunction of lower esophageal sphincter. Proton pump inhibitors (PPI) can     effectively block gastric acid secretion but the drug reactions and the degree of improvement     in symptoms are sometimes unpredictable. The aim of this study is to investigate the     association between the clinical efficacy of PPI in patients with GERD and the personal     physical status by Ryodoraku and ANSWatch.   "
86784|NCT02150122|"     It is known that low vitamin D status is a very common problem in the UK. It is also known     that a lack of vitamin D availability has potentially serious health implications, especially     with respect to bone and muscle function. Much research has recently taken place to establish     the vitamin D requirements of key population groups (i.e. pregnant women, the elderly, ethnic     minorities). However few data are available describing the vitamin D requirements for male     and female adolescents. The period of adolescence is a key stage of growth and development -     poor nutrition during this time can have detrimental health consequences for a lifetime.      No intervention studies have comprehensively investigated the vitamin D requirements of     adolescents. The proposed ODIN Study will enable a better understanding of how adolescents     respond to vitamin D supplementation and the most effective daily amount that will raise and     maintain vitamin D status in adolescents during the winter-time. In addition, investigations     into the mechanisms of action with respect to any differences observed across the doses of     vitamin D and between the genders of the participants will also provide key information.     Mechanisms of action will focus on genetic differences as well as differences in vitamin D     metabolising enzymes.      The results obtained from this significant study will not only inform the European Food     Standards Agency (EFSA) with respect to their imminent deliberations regarding vitamin D     recommendations. The ODIN Study will also inform the UK Department of Health's Scientific     Advisory Committee on Nutrition (SACN), the wider scientific community and be a critical     resource for key stakeholders (i.e. food industry, government health agencies) to collaborate     in determining future public health strategies, thus potentially positively impacting on the     health of the population for years to come.      The investigators propose that the daily supplementation of 10µg/day (400 IU) and 20µg/day     (800 IU) of vitamin D3 for five months will meet the vitamin D requirements of males and     females aged 14-18 year and will be sufficient to maintain winter-time 25OHD levels above a     range of thresholds between 30 and 50nmol/l.   "
86785|NCT02150109|"     The purpose of this study was to determine if untrained persons with diabetes and without     diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain     valid blood glucose results.   "
86786|NCT02150096|"     The objective of this study is evaluate the laser and ultrasound effect on pain and     disability in women with non-specific chronic low back pain.   "
86787|NCT02150083|"     Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many     surgical procedures have been developed to treat SUI, and midurethral slings have gradually     become the first line treatment. Voiding dysfunction, or inability for a patient to empty her     bladder, immediately after surgery is common. A bladder test is often performed in the     recovery area to see if the patient is able to empty her bladder. This typically consists of     filling the bladder with 300 mL of saline through the foley catheter. The catheter is then     removed and the patient is asked to void. The investigators then measure the voided volume     and the residual left inside the bladder to determine if she is able to empty her bladder     sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume     in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of     this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding     trial that is initiated in the operating room. Our hypothesis was that a retrograde     postoperative voiding trial initiated in the operating room would be as effective as a     standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction     while allowing for patients to spend less time in the recovery unit.   "
86788|NCT02150070|"     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK)     after intravenous (IV) administration of ASP2408 manufactured from a new production clone and     also following single ascending doses of subcutaneous (SC) injections of the same clinical     trial material.   "
86789|NCT02150057|"     Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to     participate in this randomized study. Subjects will be assigned to either a Fusion     Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is     hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on     osteoarthritis knee pain and quality of life compared to those who do not receive bracing     intervention.   "
86790|NCT02150044|"     This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial     that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery     System (TTDS).   "
86820|NCT02149654|"     Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic     Valve Implantation System in a real world environment.      Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market     study.      250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1     month, 6 months, and 12 months after the procedure. The recruitment period will be     approximately 12 months, so the total study duration will be 24 months.   "
86791|NCT02150031|"     The first time the American Heart Association (AHA) suggested that disinfection of the     gingival sulcus be performed as a complement to antibiotic prophylaxis in patients considered     to be at risk of Infective endocarditis (IE) was in their protocol for the prevention of IE     published in 1977. This practice was included by the AHA and adopted by other expert     committees such as the British Society for Antimicrobial Chemotherapy (BSAC) in subsequent     prophylactic regimens. In 1992, the BSAC specified the presentation and concentration of     chlorhexidine (CHX) that should be used before starting the dental procedure: 1% gel at the     gingival margin or 0.2% mouthwash for five minutes. In 1997, the AHA recognised the need to     use antiseptic mouthwashes (CHX or povidone iodine) prior to dental manipulations, although     they recommended against the use of gingival irrigators and against the continuous use of     antiseptics in order to avoid the selection of resistant micro-organisms In 2006, the BSAC     recommended a single mouthwash with 0.2% CHX gluconate (10 ml for 1 minute) before performing     dental procedures associated with bacteraemia in patients at risk of IE. In contrast, in     2007, the AHA recommended against the use of any antiseptic prophylaxis protocol.      In 2008, the National Institute for Health and Clinical Excellence of the United Kingdom     recently performed a systematic review of the antimicrobial prophylaxis protocols for IE and     reported that: Oral chlorhexidine used as an oral rinse does not significantly reduce the     level of bacteraemia following dental procedures. This conclusion was reached after analysis     of numerous studies on the efficacy of prophylaxis with CHX for the prevention of post-dental     manipulation bacteraemia. However, those studies presented significant methodological     differences not only in the dental procedures performed, but also in the concentration of CHX     applied and the method of application of the antiseptic solution (mouthwash and/or     irrigation), making comparison of the results of the different series difficult.      There are few studies that have analysed the efficacy of the mouthwash of 0.2% CHX (the     concentration recommended by the BSAC) in the prevention of post-extraction bacteraemia. Only     one study analysed the combination of local irrigation and mouthwash with chlorhexidine     before dental extraction, but with a really lower concentration of CHX, only 0.02%.      The objective of this study is to investigate the prevalence, duration and aetiology of     bacteraemia secondary to a single tooth extraction after prophylaxis with different CHX     protocols.   "
86792|NCT02150018|"     Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical     impedance tomography   "
86793|NCT02150005|"     Objective: The aim of this study was to examine the effects of non-surgical periodontal     treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an     indication for surgical revascularization.      Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age     (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11),     received periodontal treatment before the surgical procedure, and control group (n=11), did     not received periodontal treatment prior to surgery.   "
86794|NCT02149992|"     Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European     studies. It is not known exactly how this occurs or what it does to the sugar when the     supplement is taken. This study purpose is to look at the patient's sugar levels while taking     the supplement to see if the overall levels of sugar go down. We hypothesize that in addition     to sugar levels, other hormones influencing diabetes will be altered.   "
86795|NCT02149979|"     The purpose of this study is to evaluate the safety and effectiveness of using Temperature     Controlled Laser Soldering System for soft tissue bonding.   "
86801|NCT02149901|"     The specific aim of this study is to determine whether water ingestion potentiates the     pressor response to pseudoephedrine in patients with primary disorders of autonomic failure.     The study design will enable us to also evaluate the pressor response to water alone and to     pseudoephedrine alone. In a secondary analysis, we will compare the results in patients with     two autonomic disorders, pure autonomic failure (PAF) and multiple system atrophy (MSA). We     hypothesize that drinking water following a dose of pseudoephedrine will lead to a greater     increase in blood pressure than pseudoephedrine alone.   "
86802|NCT02149888|"     Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate     burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure     prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel     biomedical approach to HIV prevention shown in the iPrEx trial to be safe and efficacious in     reducing HIV acquisition by 44% among MSM, when provided in a comprehensive package of HIV     prevention interventions including counseling, testing/treatment of sexually transmitted     infections (STIs), and condoms. There is now widespread mobilization to assess the     feasibility of PrEP roll-out worldwide, with urgent calls for 'demonstration projects'     addressing real-world PrEP implementation issues.      PREPARATORY-5 is Canada's first PrEP demonstration project, and will examine real-world PrEP     implementation issues including acceptability, effectiveness, impact on sexually transmitted     infections, and strategies for supporting adherence outside the clinical trial setting. The     investigators have also established a comprehensive community-based research program     investigating the role of community-based organizations in PrEP implementation and delivery.   "
86803|NCT02149875|"     The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12     hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a     10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National     Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the     efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were     also analyzed among the three groups.   "
86804|NCT02149862|"     The purpose of this study is too assess infrared spectroscopy ability to discriminate urine     of a patient affected by bladder cancer from urine of reference patient.   "
86805|NCT02149849|"     Up to 85% experience shoulder pain after thoracic surgery, especially on the same side as     surgery are performed. Referred phrenic nerve pain is probably one cause of ipsilateral     shoulder pain (ISP), and positioning of the arm during surgery another. Studies indicates     that ISP can be caused by the positioning of the patient during surgery due to muscle -and     ligament strain. Can a change in the surgical positioning (less press and stretch) of the     ipsilateral arm effect the shoulder pain after thoracic surgery?   "
86806|NCT02149836|"     The purpose of this study is to test the antidepressant effects of Ezogabine in major     depressive disorder (MDD). The investigators also aim to determine the safety and     tolerability Ezogabine in patients with MDD. The investigators hypothesize that depressive     symptoms will be significantly decreased following an 8-week treatment period of the     medication compared to baseline.   "
86818|NCT02149680|"     Accidental dural puncture (ADP) during placement of an epidural catheter for anesthesia and     analgesia is a well known complication. Previous studies have found audiometric deterioration     following ADP. Epidural blood patch (EBP) is a common method for treating postural headache     in patients with accidental dural puncture. In most cases, one-two patches are needed for     successful management. Long-term effects of EBP on the incidence of backache, headache and     early audiometric deterioration are few or non-existant. The present study aims to determine     the long-term sequelae of EDP in parturients who had ADP and were treated with an EBP during     the years 2005 - 2011.   "
86807|NCT02149823|"     Social cognition impairment is critical to the pathology and morbidity of a number of     psychiatric disorders, including the schizophrenia spectrum and the personality disorders,     thus representing a dimension consistent with RDoC. As such, this study aims to a) further     characterize the unique deficits in social cognition (recognition and interpretation of     social cues and representation of thoughts, intentions, and feelings of others) in borderline     personality disorder (BPD) and schizotypal personality disorder (SPD) compared to healthy     controls (HC); b) assess the effect of intranasal oxytocin (OXT) as a regulator and novel     treatment of social cognition impairment in these disorders; and c) enhance our understanding     of the specificity and exact mechanisms of impairment to inform the accurate dosing of OXT     required to modulate social cognition in these disorders and identify a model of optimum     social cognitive function. Addressing these questions will further catalyze research into a     model of optimum social cognitive activity, and accelerate industry development of agents     suited to routine clinical administration.   "
86808|NCT02149810|"     Depression is a leading contributor to global burden of disease. Antidepressants do not     provide adequate response for many patients. Mind-body therapies are often safe, increasingly     embraced by patients albeit the limited good quality clinical trial data. The PI has shown     that there is autonomic instability in patients with late life depression (LLD). Through his     team of across discipline researchers he will investigate benefits of one adjunctive     mind-body intervention, automatic self transcending meditation on autonomic instability in     LLD and depressive symptoms compared to treatment as usual. If results are positive, such an     intervention could be used for management of LLD across all levels of care.      WHAT IS THE INNOVATION AND MAIN QUESTION/HYPOTHESIS UNDERLYING THIS PROPOSAL? The main study     objectives are to assess heart rate variability (HRV), other autonomic parameters and     depression scores in patients with late life depression undergoing an innovative mind-body     therapy 'automatic self-transcending meditation' (ASTM) not previously evaluated in a     randomized controlled manner in the treatment of late life depression:The investigators     hypothesise that in patients with LLD treatment as usual(TAU) +ASTM will lead to a     significant increase in HRV from baseline to end of study period as compared to treatment as     usual TAU. The investigators also hypothesise that ASTM+TAU will cause a significant     difference in other autonomic parameters including heart rate and blood pressure changes in     presence of a physiological stress test (hand grip), depression and depression related     pathologies such as anxiety and improve quality of life compared to TAU.      It is expected that adding ASTM to TAU will be better than TAU in improving HRV, depression     severity and other autonomic parameters in the treatment of LLD. It is expected that this     intervention will produce significant anxiolytic and enhanced quality of life outcomes and     will have no major side effects. If the results of this study are positive, it is possible     that this intervention could be considered as treatment option for the management of this     disabling illness in primary, secondary and tertiary care. Such treatment option would be     more cost and staff effective, and self empowering than the current standard of care. It     could also provide treatment options for patients who are currently resistant to their     antidepressants.   "
86809|NCT02149797|"     Cholecystectomy is one of the most common operation performed by general surgeons. Since,     first video-laparoscopic cholecystectomy in 1987, laparoscopic cholecystectomy (LC) has     become the gold standard treatment for benign biliary disease. In daily practice, LC has     increased general surgeons familiarity to video-laparoscopic operations and has become the     first step to search more minimally invasive techniques and to perform advanced laparoscopic     operations. In order to move forward the minimal invasive surgery concept with less surgical     trauma and better cosmetic results, surgeons firstly reduced the number of incision and     ports, then the idea of totally eliminating skin incisions through the use of natural     orifices was implemented in selected cases.      In theory, minimal incision must provide minimal postoperative pain and better cosmetic     results. With the use of single-incision laparoscopic cholecystectomy (SILC), this purpose is     achieved by means of cosmesis but providing minimal postoperative pain is still     controversial. Recent reports on, LC vs. SILC showed significantly favorable cosmetic     benefit, comparable complication rate and hospital stay with SILC, but the mean operation     time was significantly longer. Today, lack of standardized operation technique, the need for     specialized instruments, the fear of inability to apply safe cholecystectomy principles,     longer operation time, cost-effectivity and advanced laparoscopic experience are still     limiting factor to performing SILC.      The aim of this prospective randomized controlled trial is to compare gold standard LC and     SILC using our new technique called Pick'n roll (SILC-PR). Our goal was to provide critical     view of safety and safe cholecystectomy principles on SILC, improve operator ergonomics and     shorten operation time while eliminating the need for specialized instruments.   "
86815|NCT02149719|"     Peanut allergy is increasingly common, especially in countries such as UK and Australia.     There is currently no accepted routine clinical therapy to cure peanut allergy. Recently     studies have looked at desensitising people with peanut allergy by giving them small daily     doses of roasted peanut. Although this therapy works for some people, its effects are not     generally long lasting and it is associated with many side effects during protocol, resulting     in a significant rate of drop-outs.      Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may     therefore provide a safer way of inducing desensitisation in patients who are allergic to     roasted peanut, by first inducing tolerance to boiled peanut.      Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted     peanut, in peanut-allergic individuals.   "
86816|NCT02149706|"     Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study     of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary     Progressive SPMS.   "
86817|NCT02149693|"     Medical education was transformed from mainly didactic class before 19th century to the     clerkship and internship training based on the concept of learning by doing in 20th     century. There are new challenges for medical education in the 21th century, including     knowledge explosion, the importance of communication and teamwork in clinical care, and lack     of comprehensive and systemic experiential learning. Therefore, another paradigm shift of     medical education in this century is necessary. This research project, through applying     high-fidelity simulation, resuscitation teamwork model, and concept of flipped classroom in     resuscitation training, take the innovation and reform of resuscitation training as a pilot     test for paradigm shift of medical education.      This research project is a 4-year project. Three innovative intervention for resuscitation     training will be developed, implemented, and evaluated. There will be 4 phases in this     project:        1. Development phase (1st year): establishment of structure, validity and reliability test,          faculty development, and course preparation.        2. Experiment phase (2nd year): comparative studies will be conducted.        3. Implementation phase (3rd year): integration and implementation of innovative          interventions.        4. Evaluation phase (4th year): effectiveness evaluation and analysis of learning          retention.      Through innovation, development, implementation and effectiveness evaluation in this 4     phases, this research project hope to integrate high-fidelity simulation, resuscitation     teamwork model, and concept of flipped classroom, into resuscitation training successfully     and appropriately. Furthermore, these experiences can provide the bases of paradigm shift in     medical education in the future.   "
86819|NCT02149667|"     Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety     and efficacy of its total hip arthroplasty (THA) components marketed in the European Union     (EU) . These types of studies are required by regulatory authorities for all THA devices that     do not have medium to long-term clinical evidence available at the time of gaining approval     to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.   "
86822|NCT02149628|"     Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and     trendelenburg position which result in oxidative stress and inflammatory response.      Propofol is well known to reduce those responses during anesthesia. Therefore, we try to     figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and     increase the nitric oxide activity during robot-LRP compared to that of desflurane.      To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory     markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric     oxide will be measured as well.      Secondarily, kidney protection effect of propofol over desflurane will be compared.   "
86823|NCT02149615|"     The exact incidence of optic disc swelling and idiopathic intracranial hypertension in     patients using antiacne medication is not known so far. The investigators hypothesize that     swelling of retinal nerve fibre layer measured by optical coherence tomography is more     frequent then assumed so far.   "
86824|NCT02149602|"     This study is a phase II trial designed to test the feasibility of delivering IMRT to head     and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx),     and to assess possible improvement in reducing the incidence of xerostomia with bilateral     superficial lobe parotid sparing IMRT.   "
86825|NCT02149589|"     To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal     versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS     prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS,     Recruitment maneuvers, high PEEP and low V twill be used.      The investigators made the hypothesis that ventilation according to Lung morphology my     decrease mortality at D90.   "
86844|NCT02149329|"     A multicenter open-label non-inferiority randomized clinical trial comparing the safety     (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal     carbapenem with regard to treatment failure in comparison with extended treatment (at least 9     days) of high-risk febrile neutropenia in hematology patients receiving standard     antimicrobial prophylaxis.   "
86826|NCT02149576|"     After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or     development of a new cancer. Historically, patients who have undergone curative lung cancer     surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients     still die of lung cancer. As a result, there has been interest in other methods of     surveillance in order to detect recurring or new cancers earlier and have more success in     treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently     the standard of care and surveillance at this institution. This pilot study aims to determine     whether regimented, intensive, short interval LDCT surveillance leads to higher rates of     detection and treatment of recurring lung cancers. The study group will be followed up     according to a regimented surveillance program using LDCT. The study group will be compared     to a group of historical controls whose follow up after surgery was not standardized, but     rather left up to the discretion of the individual surgeon. If the results of this study show     improvements in detection and treatment of recurrent cancers, it will allow for a larger     trial to study the effects of the LDCT surveillance program on lung cancer survival.      The study question aims to determine whether for survivors after curative surgery for Stage I     and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the     rate of detection and treatment of recurring or new cancers when compared to historical     non-structured surveillance with CXR. This study will also determine if it is warranted to     pursue a larger scale randomized controlled trial to further investigate optimal LDCT     surveillance follow-up intervals and long-term lung cancer survival.   "
86827|NCT02149563|"     The major objective of the present study is to examine the influence of normobaric hyperoxia     treatment on the symptoms of patients diagnosed with depression members of Clalit Health     Services. The investigators hypothesize that normobaric hyperoxia treatment will improve the     symptoms of patients with depression.   "
86828|NCT02149550|"     An effective vaccine against malaria is urgently needed to combat the scourge of this     disease. Before candidate vaccines can be tested in endemic countries, they are first tested     in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a     candidate vaccine should be tested against multiple strains of malaria, representative of the     disease's global distribution. Recently we compared, for the first time, infections with the     novel malaria strains NF135 and NF166 to those with the broadly-used and well-characterised     strain NF54.      The purpose of the current study is to optimise the course of infections with these novel     strains by determining the minimum number of infectious bites necessary to reliably induce a     malaria infection.   "
86829|NCT02149537|"     The vast majority of births with sickle cell disease (SCD) occur in Africa and 90% are     thought to die before the age of five. Hydroxyurea (HU) is the only drug approved by the FDA     for the treatment of sickle cell anemia. Although HU is used to treat small numbers of     patients in Africa, cost, fear of toxicity, and lack of awareness and availability limit its     use. The leukopenia that may be seen with HU raises the possibility of increased     susceptibility to infection. Risk stratification - i.e., identification of patients most     likely to benefit- could focus therapy and provide confidence that the risk:benefit ratio is     favorable. Several clinical measures of future risk are well defined and findings on modifier     genes in the US, primarily related to fetal hemoglobin (HbF), have further improved risk     prediction. Whether the genetic variants predict severity in Africa is not known. The     investigators have established a SCD cohort in Ibadan, Nigeria. In the first phase of this     research the investigators will implement clinical risk examinations and assess the     relationship between clinical characteristics (including levels of HbF) and known genetic     markers. As a proxy for a birth cohort, the investigators will compare the frequency of the     genetic markers in adult patients (i.e., survivors) to children. In the second phase the     investigators will randomize 40 high risk adult patients to fixed low dose HU or no HU     treatment in a crossover design and monitor hematologic and physiologic parameters to     document hematologic effects and safety. This work will lay the basis for a large-scale trial     to document safety and efficacy.   "
86830|NCT02149524|"     A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the     Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab     biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally     Advanced Breast Cancer in Neoadjuvant Setting   "
86831|NCT02149511|"     In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the     level of the lesion provides evidence of neural degeneration; however, the spatial and     temporal patterns of progression and their relation to clinical outcomes are uncertain. New     interventions targeting acute spinal cord injury have entered clinical trials but     neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim     to use MRI to assess neuronal degeneration above the level of the lesion after acute spinal     cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic     spinal cord injury and healthy controls. We assess patients clinically and by MRI at     baseline, 2 months, 6 months, and 12 months 24 months and 60 months, and controls by MRI at     the same timepoints. We assess atrophy in white and brain matter and we use cross-sectional     spinal cord area measurements to assess atrophy at cervical level C2/C3. We use     myelin-sensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps to     assess microstructural changes associated with myelin. We also assess associations between     MRI parameters and clinical improvement.   "
86832|NCT02149498|"     A cornerstone in PD research is the investigation of neurophysiological changes as potential     biomarkers that could help in tracking disease progression and response to therapies.     Electroencephalography (EEG) could provide a non-invasive and relatively cheap tool for     identification of such biomarkers. In this study we will use high-density     electroencephalograph (EEG) recording, in order to develop a platform of biomarkers that     could be more sensitive and reliable to disease progression and response to therapeutic     intervention than standard clinical measures.   "
86845|NCT02149316|"     The purpose of this study is to determine whether remote ischemic preconditioning with     postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in     heart transplantation surgery.   "
86846|NCT02149303|"     This study is being conducted to collect data on the management of major bleeding events     occurring in patients with atrial fibrillation taking dabigatran etexilate.   "
86833|NCT02149485|"     Since 1995, preimplantation genetic diagnosis (PGD) has been performed in The Netherlands for     couples at high risk for transmitting severe or lethal genetic conditions or who have     experienced multiple miscarriages due to chromosomal translocations. Approximately 260     children have been born after PGD in The Netherlands. Follow-up data on children born after     PGD are scarce. Long-term studies on PGD children have not been conducted in The Netherlands.     Results of studies in other countries on 2-year old PGD children are reassuring. These     children and their parents have normal scores on relevant parameters such as general health,     cognitive and socioemotional development, parent-child interaction and parental stress.     Studies of good methodological quality of older children have not yet been published.      Objective: Long-term follow-up of children who have been born after PGD in The Netherlands.     The primary aim is to assess the safety of PGD with regard to the health and development of     the children.      Study design: A cohort study. Study population: 5- and 8 year old children born after PGD in     The Netherlands for various indications and their parents. Control groups consist of 5 and     8-year old naturally conceived (NC) children of parents who have considered PGD treatment and     5 and 8-year old children born after in vitro fertilisation/intracytoplasmatic sperm     injection (IVF/ICSI), and the parents of the two latter groups of children.   "
86834|NCT02149472|"     Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and     mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage     during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH     can be taken.      In this study the investigators aim to identify haemostatic parameters that during the course     of haemorrhage are responsible for the on-going towards major bleeding. By doing this,     cut-off points can be defined for future interventions aiming to stop this bleeding process     in an early stage. Traditional coagulation parameters are currently not useful for clinical     decision making, because of long turn around times. Therefore the added value of available     coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These     Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric     haemorrhage.      A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From     all women a bleeding score will be obtained during their pregnancy by means of a validated     questionnaire. The predictive value of this bleeding score for the occurrence of major     obstetric haemorrhage will be evaluated.      If postpartum haemorrhage develops (blood loss) > 1000 cc, blood samples will be drawn for     conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding     and major bleeding will be elucidated. Interchangeability and comparability of conventional     haemostatic parameters and ROTEM profiles will also be evaluated.      The overall goal of the investigators is becoming more able to predict major obstetric     haemorrhage in an early stage of postpartum haemorrhage and define thresholds for     goal-directed hemostatic therapies.   "
86835|NCT02149459|"     Recurrent brain tumours are extremely aggressive and despite optimal treatment, median     survival is less than two years. One of the standard treatment options in this situation is     radiation therapy. Currently there is intense scientific interest concerning the abnormal     energy metabolism in cancer cells. All cells require energy in order to function, obtaining     'fuel' molecules such as glucose and fatty acids from the blood stream. Brain tumours exhibit     metabolic reprogramming, meaning that their energy requirements and utilization of fuel     molecules are quite different from normal cells. Brain tumour cells are exquisitely dependant     on glucose as a source of energy. Animal studies have shown that when these tumours are     deprived of glucose they are very sensitive to radiation therapy.      In this clinical trial the investigators combine radiation therapy with a low-carbohydrate     diet, in patients with recurrent brain tumours. In addition, subjects will receive medication     with metformin, a drug usually used to treat diabetes. Metformin inhibits glucose metabolism     within cancer cells, and additionally has reported intrinsic anti-cancer activity. Subjects     will undergo advanced imaging and hormonal studies before, during and after the trial in     order to obtain maximal translational-scientific impact.      The hypothesis:      The metabolic changes induced by the combination of a moderately-low carbohydrate diet     combined with supplementary MCT and metformin therapy will selectively starve tumor cells.     While normal brain cells are capable of deriving energy from ketone bodies during glucose     restriction, tumor cells remain largely glucose-dependent for energy due to oncogene induced     down-regulation of oxidative phosphorylation. While the tumor cells are in this 'vulnerable'     state they will be less able to repair the damage induced by ionizing radiation.      Short-term implementation of the metabolic intervention (i.e. combined diet and metformin     therapy) prior to, during, and after hypofractionated (2 week) radiation therapy is expected     to increase tolerability, increase compliance and avoid the chronic metabolic complications     associated with extreme carbohydrate restriction diets.   "
87450|NCT02141412|"     In a prospective randomized clinical trial involving adult patients undergoing elective     surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3     doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and     quality of emergence from anesthesia versus placebo.   "
86836|NCT02149446|"     Dividing pancreas when performing left-sided resections opens the risk for leakage from the     divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding     abdominal tissues with abscess formation producing systemic inflammation and potential lethal     bleeding.      Studies have shown that reinforcement of the staple line when dividing pancreas could reduce     the risk of leakage.      Surgisis (COOK Medical) a product already in use for staple line reinforcement in gastric and     lung surgery could be used as a reinforcement when stapling pancreas in left sided     resections.      In a prospective randomized trial we want to compare Surgisis reinforcement to no     reinforcement of stapled division in left sided pancreatic resections.      Primary outcome is pancreatic fistula yes/no.   "
86837|NCT02149433|"     This is a double-blind randomized controlled trial assessing the efficacy of adjuvant     corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.   "
86838|NCT02149420|"     This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic     efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients   "
86839|NCT02149407|"     Feeding intolerance is a common problem in preterm infants.   "
86840|NCT02149394|"     The purpose of this study is to assess the efficacy of ice popsicle compared with water at     room temperature in relieving thirst in the immediate postoperative period . The hypothesis     of the study is that ice has 20% greater efficacy than water to relieve thirst in the     immediate postoperative period.   "
86841|NCT02149381|"     A total of 384 patients suffering from chronic depressive disorder will be randomized to     receive treatment as usual, CBASP, or befriending for a period of five months. The primary     outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes     in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and     neurophysiological parameters. The data gathering is performed at pre- and post intervention     stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the     participants six months after the intervention.   "
86842|NCT02149355|"     Patients suffering from congenital fourth cranial nerve palsy may have misalignment of jaws     as well as teeth due to head tilt in childhood.   "
86851|NCT02149238|"     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa     products, red wine, and tea, are associated with decreased cardiovascular mortality and     morbidity. Dietary interventional studies have corroborated this finding and showed that     flavanols can acutely and after sustained ingestion improve surrogate markers of     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event     in the development and progression of cardiovascular disease. Aging is the major     non-modifiable cardiovascular risk factor associated with progressive decline in endothelial     function, vascular stiffening and increase in blood pressure.      However, in addition to flavanols, other potentially bioactive compounds are present in     cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa     methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols     in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction     between cocoa flavanols and cocoa methylxanthines.   "
86852|NCT02149225|"     The primary objective of this study is to assess the safety and tolerability, feasibility and     biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept     in newly diagnosed glioblastoma (GB) patients.   "
86853|NCT02149212|"     About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its     highest incidence occurs from the second decade of life, affecting significantly the     economically active population. Chronic Venous Insufficiency treatment aims to relieve     symptoms, treat and prevent complications, prevent recurrences and provide cosmetic     satisfaction with minimal side effects. It's current treatment includes some classic postural     measures (leg elevation), elastic stockings and bandages compression therapy and possible     medication (phlebotonics). The results in the medium and long term are unfavorable, since a     large number of patients do not get better or evolves with recurrence of symptoms. Nowadays     many, no prospective , not randomized , international studies have shown favorable results     with endovascular treatment of obstruction in the iliac vein territory in patients with     advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded     randomized study is to evaluate the results obtained with endovascular treatment, through the     use of angioplasty and stenting in this group of patients when compared with clinical     treatment .   "
86854|NCT02149199|"     The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is     effective in treating asthma when used 'as needed' in patients with milder asthma. The     efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as     needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline     Turbuhaler® 'as needed'.   "
86855|NCT02149186|"     This project will build and test the first rehabilitation system employing virtual reality     (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and     motor dysfunction in participants with an incomplete spinal cord injury or another     neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for     legs). Patients using the system will control virtual representations of their legs to engage     in entertaining gaming interactions.   "
86856|NCT02149173|"     This clinical trial studies use of [F-18] 16 alpha-fluoroestradiol ([F-18] FES) positron     emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor     expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast     cancer or breast cancer that has come back or spread to other places in the body. Comparing     results of diagnostic procedures done before, during, and after hormone therapy may help     measure a patient's response to treatment.   "
86857|NCT02149160|"     The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics     of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin     mutation.   "
86858|NCT02149147|"     The purpose of this study is to investigate the variety of physical activity, a     cross-sectional design will be used. The data collected will provide descriptive details     about how people are engaging in physical activity, as well details about the environment     they are in while engaging in physical activity.   "
86859|NCT02149134|"     Cow's milk protein allergy is defined as an immunological reaction to one or more milk     proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk     protein allergy is suspected clinically in 5-15% of infants, while most estimates of     prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's     milk protein allergy prevalence is often due to differences in study populations, study     design and a lack of defined diagnostic criteria. The importance of defined diagnostic     criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids     delay in diagnosis, which can lead to malnutrition.      There are two clinical types of cow's milk protein allergy: the immediate and the delayed     type. The immediate type usually presents within minutes after the ingestion of cow's milk     protein with urticaria, angio-oedema, vomiting or an acute flare of atopic dermatitis and is     present in slightly more than half of the patients with cow's milk protein allergy. Delayed     reactions such as atopic dermatitis or gastrointestinal symptoms like proctocolitis or     enteropathy usually present after hours or days.      Immunologically, cow's milk protein allergy can be IgE or non-IgE mediated. IgE mediated     reactions are often of the immediate type. Non-IgE mediated reactions are often cell mediated     or mixed cell and IgE mediated and are more difficult to prove by specific testing. The     immunological reaction differentiates cow's milk protein allergy from other milk induced     pathology such as lactose intolerance.      A variety of symptoms can be suggestive for cow's milk protein allergy although none of them     is diagnostic. A good medical history remains the cornerstone for the diagnosis.      The treatment of cow's milk protein allergy is the dietary elimination of cow's milk     proteins. In non-breastfed infants and children less than 2 years of age, a substitute     formula is mandatory as prescribed by several international scientific societies. Extensively     hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is     often a whey or casein based formula in which the protein has been chopped up in smaller     pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional     inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant     should be maintained on an elimination diet until the child is between 9-12 months of age or     at least for 6 months, whichever occurs first. In most cases, symptoms will improve     substantially within 2-4 weeks if diagnosis is correct.      According to consensus in literature, a therapeutic formula is a formula tolerated by at     least 90% (with 95% confidence) of cow's milk protein allergy infants.      The aim of the investigators study is to show the efficacy, tolerance and nutritional     adequacy of a newly developed thickened extensively hydrolyzed formula in infants with a     proven cow's milk protein allergy. In all included patients, cow's milk protein allergy will     have been diagnosed based on a double blind placebo controlled food challenge, considered as     golden standard in cow's milk protein allergy diagnosis. To evaluate efficacy of the formula,     the formula has to be tolerated by at least 90% (with 95% confidence) of cow's milk protein     allergy infants following literature consensus. A symptom diary will be filled out for this     purpose by the patients' parents or legal guardians and the patient will be followed     clinically by his doctor several times during the study period.      Nutritional adequacy of the formula will be evaluated clinically by following growth and     weight several times during the study period and by comparing it to the standard WHO growth     curves, based on breastfed infants.   "
86862|NCT02149095|"     TransCon PEG treprostinil is a novel prodrug form of treprostinil, in which treprostinil is     reversibly conjugated via a four-arm branched polyethylene glycol (PEG) molecule. Reversible     coupling of treprostinil to PEG should allow for a modified extended pharmacokinetic profile     to achieve sustained plasma concentrations of treprostinil.      This will be the first investigation of TransCon PEG treprostinil in humans. This study aims     to determine the maximum tolerated dose (MTD) and assess the safety, tolerability and     pharmacokinetics of escalating single doses of a subcutaneous injection of TransCon PEG     treprostinil.   "
86863|NCT02149082|"     This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density     (OD) measurement with an Infrascanner device accurately identifies the presence of an     intracranial hematoma in pediatric patients ≤18 years of age after known or suspected     traumatic brain injury compared with head computerized tomography (CT) scans as the gold     standard.   "
86864|NCT02149069|"     A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to     patients undergoing complex surgical procedures.   "
86904|NCT02148549|"     FOLFIRINOX regimen was recently presented at an international oncology meeting and represents     a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of     the high response rate treatment regimen , the investigators considered as a promising     treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4     neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX     group compared with gemcitabine group. Therefore, it was decided to consider the balance of     safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen     by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from     FOLFIRINOX regimen   "
86865|NCT02149056|"     Background About 2/3 patients of coronary heart disease (CHD) are complicated with disorder     of carbohydrate metabolism which results in hyperglycemia and subsequent abnormality of     coagulation system and inflammation. These patients have serious coronary artery pathology,     multiple complications and poor prognosis. Platelets and lymphocytes play important roles in     the occurrence and progression of atherosclerosis. The platelet/lymphocyte rate (PLR) is one     simple hematological index. Previous studies confirmed that PLR could predict the long-term     mortality of non-ST elevated myocardial infarction (NSTEMI). If simple hematological index     could predict the prognosis of such kind of patients, it will provide new thought for early     diagnosis and treatment in future. Therefore, the present study try to investigate if PLR     could predict the poor prognosis of CHD patients complicated with impaired glucose tolerance     (IGT) through calculating PLR.      Methods/design The present study is performed with strategy of an observational and     prospective single-centre cohort. These patients are recruited from August 2013 to August     2014, according to the inclusion criteria of CHD complicated with IGT. CHD is confirmed with     coronary angiography while IGT is determined according to the WHO criteria (1999). Routine     blood test and serum glucose data of patients are acquired before hospitalization and     surgery. According to the median of PLR after admission, the patients are divided into 3     groups. The patients are followed up for half, 1 and 3 years, respectively. The major     clinical endpoint is mortality. The minor clinical endpoint indices are the correlations of     PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of     target vessels), recurrent infarction, re-perfusion rate of target vessel, intra-stand     thrombogenesis, stroke and acute onset of heart failure. The correlations are analyzed with     receiver operating characteristics (ROC) survival curve and Kaplan-Meier survival analysis to     find optimal prognosis index.      Summary Through regression analysis of long-term follow-up of patients, it is expected to     find optimal predicting index of prognosis. While judging whether PLR is effective, other     possible factors for new predictor are sought in order to provide help for future study.   "
86866|NCT02149043|"     Ulcerative colitis represents a chronic condition occurring in relapsing and remitting     fashion with uncertain outcome and requires lifelong treatment with considerable side     effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or     laboratory (C - reactive protein, calprotectin) give an insight into disease activity, but     are possibly associated with significant discomfort for the patient and / or increased risk     of irradiation and potential allergic reactions on contrast agents. For that reason there is     a need for a noninvasive, biologically inert method for evaluation of disease activity in     inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The     aim of this study is to find potential link between pathological thermographic signs and     endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients     with active and extensive ulcerative colitis.   "
86867|NCT02149030|"     The main objective of the study is to identify whether or not being informed infrequently     results about screening is: 1) At least as safe and accurate as frequently obtaining all     information from the present combination of opportunistic/organized cervical screening by     comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm     A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human     papillomavirus (HPV) vaccinated young women.   "
86868|NCT02149017|"     To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic     radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and     healthy volunteers.   "
86869|NCT02149004|"     Despite major advances in therapy and management, HIV/AIDS continues to be a major cause of     infectious disease morbidity and mortality on a global scale. The discovery of effective     antiretroviral treatment has turned HIV infection into a manageable chronic disease in most     patients with access to care. However, the different economic and epidemiologic situation in     developing and developed countries requires different research priorities, so that three main     challanges are universal and in focus of research of the DZIF HIV Translational Platform:        -  Prevention of HIV infection        -  Long-term life with HIV        -  HIV cure      The Translation Reserach HIV will bring together clinical researchers in HIV infection in     order to develop new treatment options to the above mentioned main challanges. It will take     advantage of existing expertise (e.g. basic science, novel targets for treatment and HIV     eradiation) of the partner sites. This platform is necessary because Germany's HIV research     has suffered in the past from a lack of integration between its excellent basic science and     clinical research. In addition, there was too little integration into networks that address     the main international challenges. There is an urgent need to link these research strands     through dedicated structures emphasising the translation of preclinical results into new     therapies.   "
86882|NCT02148835|"     New approaches to increase eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in our     diet are needed, but any new approach needs to demonstrate the bioavailability of EPA+DHA,     and its safety and palatability. The HS-Omega-3 Index is a prime parameter to demonstrate     bioavailability in the long-term. Study hypothesis is that increased intake of EPA+DHA will     increase the HS-Omega-3 Index. Study aim is to investigate how supplementing various sausages     with omega-3 fatty acids influences the HS-Omega-3 Index in healthy volunteers, as compared     to unsupplemented matching sausages. Safety and palatability of the sausages are also to be     assessed.   "
86870|NCT02148991|"     Arterial hypertension causes adverse effects on the entire cardiovascular system, with     effects centrally such as diastolic dysfunction and structural changes of the left ventricle     and, peripherally such as endothelial dysfunction and increased thickness of the vessels.      Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc. further     aggravate the prognosis of these patients.      In addition the rate of patients aged > 65 years suffering from un-diagnosed or diagnosed     arterial hypertension was 78% for women and 64% for male patients. This population consists     from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more     comorbidities and probably less compliance with antihypertensive therapy. Finally, at every     age the disease and its effects can affect the quality of life of patients.      The main purpose of this study is to investigate the efficacy of antihypertensive therapy     (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular     system (diastolic left ventricular function, the function of the endothelium (FMD) and the     thickness of the common carotid artery).      The secondary objective of the study is to monitor the quality of life (Quality of Life -     QoL) of patients.      Additionally the investigators will seek the correlation of results with co-morbidities,     compliance, and patient age.   "
86871|NCT02148978|"     Cystic Fibrosis (CF) is a chronic disease characterized by recurrent pulmonary infections and     exocrine pancreatic insufficiency. The vast majority of patients with CF will develop     pancreatic endocrine insufficiency over time manifested as altered glucose metabolism. The     presence of overt diabetes in patients with CF is associated with adverse clinical outcomes.      The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter     of investigation. In addition to localized tissue damage developing similar to that of the     exocrine pancreas, additional mechanisms may be involved. The investigators have recently     shown that insulin secretion in patients with CF is significantly altered prior to the     development of diabetes. This phenomenon is associated with reduced secretion of gut derived     incretins (specifically GIP). The blunting of incretin induced insulin secretion (whether due     to a deranged interaction of gastrointestinal contents with enterocytes resulting in reduced     secretion or due to rapid clearance of such peptides) may be a major underlying driver of     altered glucose metabolism in such patients.   "
86874|NCT02148939|"     Many patients suffer from acute and chronic pain. The incidence of chronic pain correlates     with increased age. Most of patients rely on analgesic medication to control the pain.     Dipyrone is an extensively used drug in Western and Eastern Europe as well as Central and     South America, largely due to its favorable analgesic and antipyretic effects in conjunction     with a low incidence of gastrointestinal complications when compared to other non-steroidal     anti-inflammatory drugs (NSAIDs).      Aspirin is the backbone of antiplatelet therapy in patients after ischemic stroke. However,     it is known that there are substantial inter-individual response variabilities to     antiplatelet medication. Furthermore, patients with impaired response to aspirin have a     significant higher risk of recurrent cerebrovascular events. The investigators have recently     shown that co-medication with aspirin and dipyrone in patients with coronary artery disease     lead to insufficient antiplatelet effects of aspirin.      The incidence of chronic pain is very high in patients with ischemic stroke. Therefore, in     this study the investigators aim to examine, if co-medication of aspirin and dipyrone     interaction also occurs in patients after ischemic stroke.   "
86875|NCT02148926|"     This study is a descriptive study to investigate clinical and genetic features of dilated     cardiomyopathy (DCM) patients and their relatives. 109 probands with DCM have been clinically     characterized with clinical examinations including ECG and echocardiography, and furthermore     they have had next generation sequencing (NGS) of 42 known DCM genes, and 34 candidate genes.     The probands were consequtively included in the study and 59 had undergone heart     transplantation (HTx) upon inclusion. of these patients underwent heart transplantation. The     data from NGS is validated by Sanger sequencing. In this study we will examine the relatives     to the 109 index patients by genetic and clinical cascade screening including advanced     echocardiography including 3D volume measurements and speckle-tracking (GLS). Genetic     investigations of relatives will be performed if a disease-associated mutation is identifed     in the proband. Approximately 480 clinical examinations will be performed this way to be able     to:      1a. Investigate the frequency of familial types of DCM      1b. To investigate the yield of genetic and clinical cascade screening      2. To describe genotype phenotype correlations      3. To investigate if there are subtle changes in the heart in genopositive individuals which     do not meet the conventional diagnostic criteria evaluated by advanced echocardiography.   "
86876|NCT02148913|"     This is a phase I clinical trial. Patients with a diagnosis of multiple myeloma undergoing     autologous transplantation will receive a preparative regimen of melphalan, bendamustine, and     carfilzomib. We hypothesize that the addition of carfilzomib to a conditioning regimen of     melphalan and bendamustine in the setting of autologous transplantation for multiple myeloma     is feasible and safe.   "
86877|NCT02148900|"     The objective of this study is to determine whether a simple blood test can be a useful     clinical tool for monitoring aortic disease in Marfan syndrome and Marfan-related disorders.   "
86878|NCT02148887|"     We aim to investigate the effect of motor skill training of the upper and lower limbs on the     function and structure of the CNS as measured by neuroimaging parameters sensitive to changes     in tissue volume and density and the properties of myelin.   "
86879|NCT02148874|"     This study will examine effects of everyday life stress and obesity on immune responses to     influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody     levels against influenza (the flu) increase. Higher antibody levels indicate better immune     protection from influenza. In addition to providing protection from the flu for yourself,     being vaccinated during pregnancy may protect your baby from the flu during the first six     months of life during which time infants cannot be vaccinated. Our primary goals are to     determine whether greater life stress and obesity reduce 1) antibody responses to the flu     shot in women and 2) antibody levels in the newborn at the time of delivery.   "
86880|NCT02148861|"     This trial is conducted in Europe. The aim of the trial is to investigate the safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously     administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes   "
87451|NCT02141399|"     This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.   "
86883|NCT02148822|"     The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess     the association between malnutrition and visceral leishmaniasis (VL). It was conducted in     Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical,     anthropometric, biochemical, immunological, parasitological and sociodemographic data of     school age children from VL high prevalence communities were collected in December 2009, May     2010 and February 2011.   "
86884|NCT02148809|"     Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital.     This type of anesthesia reduces the average arterial pressure. Benefits include reduced     bleeding and lower risk of blood clots.      The purpose of this study is to determine the effect of intravenous fluids administered with     hypotensive anesthesia on your blood volume. With this parameter we will be able to     understand how much of your blood is lost because of bleeding and how much of the drop is     related to dilution.      Study hypothesis: Hemodilution associated with intravenous fluid substitution during     hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels   "
86905|NCT02148536|"     To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt     (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).   "
86886|NCT02148783|"     Deficits in memory, attention, cognitive, and executive functions are the most common     disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is     implicated in these neural functions and dopaminergic pathways are recognized to be     frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate     (Ritalin®). Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine     transporters (DAT) and blocking re-uptake. PET with methylphenidate challenge to measure     tonic DA release provides valuable insight into the molecular basis of attention-deficit     hyperactivity disorder (ADHD) and addiction, as well as practical information regarding     likely effectiveness of therapy (1). The objectives of this study are to use PET imaging with     [11C]-raclopride, a D2/D3 receptor ligand, before and after administering methylphenidate, to     measure endogenous DA release in patients who are experiencing problems with cognition,     attention and executive function in the chronic stage after TBI. In addition, we will use TMS     to test short intracortical inhibition, a gamma-aminobutyric acid receptor A (GABAA) -     mediated phenomenon, which is under partial DA control, as a measure of dopaminergic activity     on and off methylphenidate.   "
86887|NCT02148770|"     Neuroimaging is becoming increasingly common to investigate the neural networks underlying     eating behaviour and food preference in normal-weight and obese humans. It has been observed     that obese in comparison to lean individuals display altered activation patterns in networks     of brain areas involved in reward, emotion and cognitive control. Interestingly, obese     individuals who are capable of losing weight appear to have a stronger connectivity between     areas related to food value and to the control of eating behaviour. The same areas are also     associated with healthy food choices. It has been suggested that activation in the prefrontal     control areas indirectly modulate valuation-related activity. Based on this, brain-related     intervention strategies to support weight loss and long-lasting weight maintenance are of     particular interest. Hence, we first want to examine the effect on eating behaviour of     neurofeedback training-induced up-regulation of functional connectivity between reward- and     impulse-related brain areas as a pilot, and second we want to examine up-regulation of the     activity of prefrontal control brain areas.   "
86888|NCT02148757|"     Purpose of this study is to determine the incidence of deep venous thrombosis after partial     knee replacement.   "
86889|NCT02148744|"     This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled,     ascending dose study to investigate the safety, tolerability, and pharmacokinetics of     XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.   "
86890|NCT02148731|"     MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are     better at detecting vulnerable patients and that they are a better Adverse Events     predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients     referred for chemotherapy. The second hypothesis is that a brief screening tool based on a     combination of some frailty markers and some used in the CGA would help the oncologist detect     patients requiring a more complete geriatric assessment   "
86891|NCT02148718|"     Rapidity of response to treatments in inflammatory bowel diseases is now considered a field     of major interest, due to the importance of achieving the highest benefit in the shortest     possible time, in order to favor a fast backward step to normal life. There are no previous     studies specifically designed to evaluate the rapidity of response to adalimumab therapy in     patients with active Crohn's disease. Studies on rapidity of onset of response to adalimumab     have, on the other hand, been performed in other diseases such as rheumatoid arthritis     (Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis HERO study, Wolfe et al,     2006). This trial will assess the clinical responses occurring earlier than in week 1. This     is an open label, one arm, prospective, multicenter, phase IV clinical trial.   "
86892|NCT02148705|"     This study will be a three-arms study intending to demonstrate superiority of NexoBrid     treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn     subjects.      The study objectives are:        1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing          complete eschar removal as compared with Gel vehicle,        2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing          earlier complete eschar removal, reduction in patients' surgical burden and its related          blood loss as compared to SOC,        3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment          with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and          long term outcomes of cosmesis and function.      Physicians will define one or more Target Wounds (TWs) per subject according to TWs     definition. All subjects' deep (DPT and FT) burns that comply with the specified entrance     criteria are intended to receive study treatment per the randomized study arm.      The randomization procedure will be initiated only after all Target wounds of a subject have     been defined. Patients will be assigned to the treatment arm in a 3:3:1 ratio (NexoBrid: SOC     : Gel Vehicle).      Patients will be treated in the same way in all study arms (NexoBrid, SOC or Gel vehicle)     except for the eschar removal stage which will be performed as per the randomization study     arm.      Prior to initiation of eschar removal treatment, subjects will be medicated with appropriate     analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions     . Following wound cleansing and antibacterial treatments, subjects will undergo the eschar     removal process as per treatment assignment (NexoBrid, SOC or Gel Vehicle, following     randomization).      Subsequent to complete eschar removal, all wounds will be assessed and treated in the same     manner, in accordance with post-eschar removal wound care strategy. Post eschar removal,     subjects will undergo daily vital signs and pain assessments, until hospital discharge (HD)     and weekly assessments of wound progress, until wound closure. Following wound closure     confirmation visit, subjects will be followed up at 1, 3, 6, 12, 18 and 24 months post wound     closure for long term outcomes evaluation.   "
88514|NCT02127489|"     This study aimed to compare the efficiency of rectal midazolam addition after applying     bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional     analgesics, postoperative recovery, sedation, and to find out its adverse effects in children     having lower abdominal surgery.   "
86893|NCT02148692|"     Postoperative respiratory failure, particularly after surgery under general anesthesia, adds     to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use     positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may     improve oxygenation and protect against postoperative pulmonary complications (PPCs),     especially in obese patients. While anesthesiologists tend to use PEEP higher than in     non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP     with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of     PEEP with recruitment maneuvers could compromise intra-operative hemodynamics.      The investigators aim to compare a ventilation strategy using higher levels of PEEP with     recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in     obese patients at an intermediate-to-high risk for PPCs.      We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and     recruitment maneuvers, as compared to ventilation with lower levels of PEEP without     recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for     PPC.   "
86894|NCT02148679|"     Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or     attention control for 4 weeks after hospital discharge.   "
87651|NCT02138773|"     The purpose of this study is to investigate the relative bioavailability of two types of     prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The     safety of tamsulosin formulation is also compared.   "
86895|NCT02148666|"     One of the challenges of stem cell therapy is to understand the fate of the injected stem     cell. By labelling various stem cells with radioisotopes their fate (homing) can be     demonstrated. In this study, we will develop and refine the existing techniques of stem cell     labelling to various subtypes of stem cells namely- freshly aspirated bone marrow cells,     cryopreserved bone marrow cells, g-csf mobilized peripheral blood stem cells and umbilical     cord cells. After testing the labelling efficacy and viability, these cells will be injected     in to the coronary arteries of patients with myocardial infarction who have undergone a     successful revascularization either by angioplasty or thrombolysis. Homing of stem cells will     be demonstrated by nuclear scan after the procedure. We are adapting techniques used to label     cells for detection of infection and bleeding using nuclear scans for in vivo scanning. Also     we are using Technetium instead of FDG which has very little radioactivity allowing us to     work with the current cardiac labs with out having to reconstruct the labs with special     shielding for radioactive compounds. Real benefit of stem cells then can be explored after     demonstrating the proper homing.   "
86896|NCT02148653|"     Main scientific question:      A previous intervention with an anti-inflammatory multifunctional dietary portfolio (MFD)     showed remarkable reductions in cardiometabolic (CM) risk markers compared with a     well-designed control diet. The study was performed under weight maintenance conditions in     healthy subjects in a 4w crossover design (Tovar et al., 2012). MFD consumption also resulted     in improved cognitive performance after 4 weeks (Nilsson et al., 2013).      The present project will further study the preventive potential of MFD, using its unique     properties for identification of new biomarkers and to evaluate the potential role of     alterations in the gut microbiota. MFD will be tested in healthy at risk subjects in a     randomized parallel design in an eight-week intervention with the test or control diet,     respectively, allowing for weight loss. Assessment of standard anthropometric/biochemical     markers of CM risk, metabolomics analysis and appetite regulating hormone evaluation are also     planned. Associations between the gut microbiota composition and measures of CM risk are also     included. The project provides unique opportunities to identify mechanisms for the metabolic     impact of MFD, for further exploitation in innovative food and/or dietary concepts.      Central hypothesis:      The CM-preventive potential of MFD may be boosted in a medium-term trial under conditions     allowing for body weight reduction. Expected additional benefits may be recorded as reduced     values for conventional CM-related parameters, markers of modified gut microbiota composition     and specific changes in blood metabolite profiles.      Objectives:        -  To further improve the effect of MFD on biochemical/anthropometric CM risk markers in          healthy subjects by administering the diet under conditions allowing for weight          reduction.        -  To identify MFD-related changes in the gut microbiota associated with improved CM risk          markers.        -  To assess MFD-related modification in metabolic pathways, studied with a metabolomics          approach, and to correlate them with conventional clinical outcomes, aiming to identify          new markers of altered metabolic risk.   "
86897|NCT02148640|"     The purpose of this study is to assess the safety and efficacy of switching from Remicade to     the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis,     psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis   "
86898|NCT02148627|"     The main purpose of this study is to evaluate the safety of LY3041658 in healthy     participants, including first generation Japanese. The study will also investigate how the     drug is processed and affects key immune cells. Study participation will last 4 months.      Protocol amended in January, 2016 to include first generation Japanese participants.   "
86899|NCT02148614|"     AIMS      Phase 1. Verify whether the intake of LibramedR is able to induce a better endocrine and     metabolic profile.      Phase 2. Verify whether treatment with LibramedR for 60 days produces a better glycaemic     profile after oral glucose load.      SUBJECTS      Will be recruited 80 obese children for phase 1 and 40 obese children for phase 2.      Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind     clinical trial.      METHODS      Experimental protocol phase 1      Each child will arrive at the UOC at 8 a.m., in fasting. A blood sample will be taken. Then     patients will be given two LibramedR tablets or placebo. After 20 minutes they will be given     a mixed meal (equal to 15 kcal per kg of lean body mass). Blood samples will then be taken at     30-minute intervals for the first two hours and 60 minutes for the following two hours, for     the determination of metabolites and hormones for a total of 4 hours. The level of satiety     will be quantified through a visual analog scale.      Experimental protocol phase 2      Based on the results of the OGTT performed in recruitment phase, children will be divided     into two groups: group A, children with blood glucose 2 hours after oral load higher than the     median and group B, children with blood glucose 2 hours after oral load below the median.      The children of group A will be randomly assigned to LibramedR treatment or placebo for 60     days, after which they will repeat Anthropometric measurements, bioelectrical impedance, OGTT     and blood chemistry. They will also repeat dietary and sport anamnesis .      During the 60 days, the children of both groups will receive the same dietary treatment     consisting of a low-calorie and balanced diet, and recommendations to practice more sport.      Every 15 days a research assistant will contact the families to reinforce treatment     adherence.      EXPECTED RESULTS      Phase 1 LibramedR intake should cause a lower increase in postprandial blood glucose,     insulin, triglycerides and a greater decrease in ghrelin levels compared to placebo     treatment;      Phase 2 The treatment with LibramedR should be associated with a decrease in blood glucose     and insulin secretion after OGTT compared to placebo treatment.   "
86913|NCT02148432|"     Venous thromboembolism(VTE) is the third most common cardiovascular complication among     hospitalized patients, and can even cause death. VTE often occurs in intensive care patients     and there had been many efforts to prevent such complication. The American College of Chest     Physicians (ACCP) had published evidence-based clinical practice guideline for VTE     prophylaxis.      This study focuses on how VTE prophylaxis is being performed in both medical and surgical     ICUs in a single University hospital, and sees the differences in such prophylactic patterns.   "
87909|NCT02135406|"     The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T     cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19     cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB     administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T     cells on day +2 after autologous stem cell infusion following high-dose melphalan.   "
86900|NCT02148601|"     In the recent past, a deep change in the epidemiology of C. difficile infection has occurred,     with a rise in its frequency, severity, and mortality. Both the refractoriness of the     infection to standard therapy and its probability of recurrence have also increased,     representing a main clinical issue. Fecal microbiota transplantation (FMT) refers to the     introduction of a liquid filtrate of stools from a healthy donor into the gastrointestinal     tract of a patient for the treatment of specific diseases. FMT has shown outstanding results     in the treatment of recurrent C. difficile infection. It can be performed through various     routes: nasogastric or nasojejunal tube, upper endoscopy, retention enema, colonoscopy. In a     recent systematic review of studies using FMT for the treatment of recurrent C. difficile     infection, Cammarota et al. observed that lower gastrointestinal route (colonoscopy, enema)     led to the achievement of higher eradication rates than upper delivery (gastroscopy,     naso-gastric or naso-jejunal tube) (81-86% vs 84-93%, respectively). In a randomized clinical     trial, Van Nood et al. showed the efficacy of FMT by nasojejunal tube in recurrent C.     difficile infection. Up to now, data on FMT by lower route come out only by case series and     case reports.      The investigators' aim is to compare the efficacy of colonoscopic FMT and standard antibiotic     therapy for the treatment of C. difficile infection in a randomized clinical trial   "
86901|NCT02148588|"     Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study     will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal     and mechanical responses in CPSP, and assesses the associated local anesthetic     pharmacokinetics.   "
86902|NCT02148575|"     The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care:     A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care     and to facilitate its timely integration into self-management of their breast cancer. The MCC     will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months     following enrollment. The intervention group will receive the MCC, and the attention-control     group will receive a symptom management toolkit. Participants' family caregivers will also be     enrolled to provide information on patients' self-management. Investigators hypothesize that     users of MCC, as compared to attention-control participants, will demonstrate improved     knowledge, feelings, and behaviors related to self-management of their cancer care. This     innovative research can help to establish palliative care as a mainstay of self-management     interventions that target serious illnesses.   "
86907|NCT02148510|"     The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on     respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same.     The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment     and the cost of treatment during one year.      This randomized controlled parallel group multicenter study includes 316 subjects referred     for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the     clinic at 5 scheduled occasions.   "
86908|NCT02148497|"     The purpose of this study is to show that the multi-colored Placido Disk set-up can get     reliable data over long time periods.   "
86909|NCT02148484|"     Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse     survivors and is associated with substantial psychosocial and medical problems, but     evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the     efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered     therapy.   "
86910|NCT02148471|"     The first aim of this study is to assess oxidative stress and nutritional status in patients     with elevated liver enzymes who were found to have either simple steatosis (SS) or     nonalcoholic steatohepatitis (NASH) or normal histological findings on liver biopsy by     measuring liver lipid peroxides and tumor necrosis factor (TNF)-α, liver pathology and     immunohistochemistry, liver function tests, liver and red blood cell membrane fatty     composition, insulin resistance (IR) parameters, plasma lipid peroxides, plasma antioxidant     vitamins and antioxidant power, lipid profile, subject demographics, medical history and     medication use. The second aim is to detect differences in hepatic gene expression (messenger     RNA, mRNA) and epigenetic regulation (micro RNA, miRNA) between patients with SS or NASH and     healthy controls, in addition to determine in patients with non-alcoholic fatty liver disease     (NAFLD = SS+NASH combined) whether there is an association between hepatic n-3 PUFA content     and gene expression. The third aim is to determine the intestinal microbiome (microbial     composition and metagenome) in patients with SS or NASH and healthy controls.   "
86911|NCT02148458|"     The purpose of this research study is to evaluate the effects of intermittent fasting in     subjects that are eating a Mediterranean diet or a Western diet. This study is part of     ongoing research in the prevention and treatment of age-related diseases at Washington     University School of Medicine.   "
86912|NCT02148445|"     Long-term NRT has not been studied in patients with COPD, and smokers in the United States     with COPD are still asked to choose between immediate quitting or continued smoking. The     purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT,     might prove to be a reasonable alternative to the standard approach of asking patients to     quit immediately. The investigators believe that GMT with long-term NRT will reduce overall     exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater     quit rates.      In this study, 398 smokers with COPD will be randomly assigned to either receive: 1)     traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT     (GMT). The SC intervention will be based on a standard approach to smoking cessation,     including smoking cessation counseling supplemented with combination NRT (a nicotine patch     plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The     GMT intervention will consist of counseling, focused on medication adherence and smoking     reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will     compare the two treatments based on their effects on smoking cessation, number of cigarettes     smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing     function, and smoking-related hospitalizations or death. The investigators will also analyze     the data in such a way that will be able to identify which patients are most likely to     benefit from treatment. This analysis will allow patients to estimate their chances of     success based on their own personal characteristics and which treatment they choose.      The investigators study addresses research priorities identified in recent smoking cessation     guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder     Advisory Committee. This study reflects the interests expressed by smokers in prior surveys     and addresses the limited reach and effectiveness of traditional approaches to smoking     cessation. If our GMT approach is effective, our study could change the recommendations     provided in clinical practice guidelines and change the way that insurance companies pay for     smoking cessation treatment. GMT could provide an alternative for millions of smokers with     COPD who are not currently benefiting from traditional approaches to smoking cessation   "
87910|NCT02135393|"     The aim of this study is to test the assumption that, in humans, folic acid, a dietary     supplement is biotransformed (reduced and methylated) to the natural circulating plasma     folate 6S-5Methyltetrahydrofolic acid (5-MTHF) in the intestinal mucosa.   "
86914|NCT02148419|"     Between 2007-2010 the Child Protection Team (CPT) at University Children's Hospital Zurich     was the first in Europe to follow up the development of maltreated children in a hospital     sample . The follow-up took place 2-3 years after the child had been reported to the CPT. As     a major result, children's health-related quality of life (HRQoL) had been impaired in     maltreated children compared to controls (Jud, Landolt, Tatalias, Lach, & Lips, 2012).     However, this difference only emerged for the self-assessment of HRQoL by children aged 6     years or older .To address limitations, the CPT at University Children's Hospital Zurich and     Children's Hospital Baden AG propose a prospective study with a baseline at the time of     report to the CPT and a two year follow-up. This study aims at analyzing HRQoL, behavior and     mental health of maltreated children prospectively and will be the first to provide data on     changes in HRQoL in the aftermath of maltreatment. We assume the following hypotheses:        -  The HRQoL and mental health of children will be impaired following maltreatment even          while controlling for others possible predictors of impaired HRQoL and mental health.        -  We assume a dose-response relationship between severity of maltreatment and impaired          HRQoL. Multiple maltreatment is hypothesized to have a larger impact then a single type          of maltreatment.        -  At baseline, HRQoL scores are hypothesized to be at a markedly low level. We assume a          slight increase in HRQoL from baseline to first follow-up, but not a continuing increase          to second follow-up.   "
86915|NCT02148406|"     This randomized pilot clinical trial studies Yoga Skills Training or attention control in     reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV     colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing     practices that aim to promote mindfulness and relaxation. Attention control consists of     conversations with a caring professional with a recommendation to complete daily home     diaries. It is not yet known whether Yoga Skills Training is better than attention control at     reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of     this initial feasibility study is to refine study procedures.   "
86916|NCT02148393|"     A randomised controlled open-label clinical trial to compare the clinical pregnancy rates     between fresh embryo transfer and elective all-embryo vitrification with thawing and transfer     in a subsequent cycle in high-responders   "
86917|NCT02148380|"     The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and     OS of patients with NSCLC. However, outcome of the combination therapy are similar to those     reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line     treatment for patients who harbored a sensitive EGFR mutation? The investigators need a     head-to-head study to reply.   "
86918|NCT02148367|"     -  Traumatic brain injury (TBI) is the leading cause of death and disability in people          under age 45 in industrialized countries. Significant numbers of US veterans from the          wars in Iraq and Afghanistan return with TBI. However, to date, there are no specific          neuroprotective treatment options with proven clinical efficacy.        -  Erythropoietin (EPO) is approved by the FDA to treat anemia and has comprehensive          preclinical data supporting its neuroprotective and neuroregenerative efficacy following          traumatic (TBI) and a wide range of other acquired brain insults. Injury to small and          medium-sized cerebral blood vessels is a well recognized consequence of TBI. EPO          increases production of endothelial progenitor cells (EPCs) and promotes angiogenesis          and neovascularization after TBI. EPO also promotes neurogenesis and improves functional          recovery in animals after experimental stroke and TBI. Neovascularization is coupled          with neurogenesis, and augmentation of both processes by EPO may result in lessened          cognitive deficits. Neovascularization by EPO may prevent post-traumatic deficits in          cerebrovascular reactivity (CVR), which can be measured noninvasively using magnetic          resonance imaging (MRI).        -  This proposal is for a randomized, placebo-controlled pilot clinical trial designed to          obtain data on the effects of EPO in humans with persistent post-concussive symptoms          after TBI. The primary objective is to evaluate effect of 4 week administration of          recombinant erythropoietin on numbers of circulating endothelial progenitor cells in          patients with persistent symptoms during the subacute period after TBI. This information          will guide the design of a future definitive study.   "
86919|NCT02148354|"     The purpose of this study is to determine the differential effectiveness of a self applied     treatment delivered via Internet for the prevention and treatment of depression, with or     without support by the therapist, compared to a waiting list control group. The principal     hypothesis is that the two intervention groups will improve significantly compared to the     waiting list control group, and without significant differences between them. The     investigators believe that the support of ICTs may be doing a similar function as the weekly     support call (to offer feedback, to reinforce, to motivate the participants, etc.).     Furthermore the investigators hypothesize that the intervention program will be a useful tool     for a secondary and tertiary prevention of depression.   "
86920|NCT02148341|"     This study determines if a community of practice of clinicians and quality improvement     specialists can be used to implement a national quality initiative known as Hospital to Home     (H2H). This quality initative is designed to reduced readmission rates for patients with     heart failure or heart attack by improving the transition of care upon discharge.   "
86921|NCT02148328|"     The purpose of this study is to examine the safety and tolerability after administration of     trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.   "
86922|NCT02148315|"     The purpose of this study is to determine whether school gardens affect children's physical     activity.   "
86931|NCT02148198|"     Part 1 of the study will assess the effect of 1g, 2g and 5g doses of NWT-03 on systolic and     diastolic blood pressure in a cross-over designed study in healthy adults with normal, high     normal and mild hypertension. Based on results from this study, one dose will be selected for     a placebo controlled parallel study assessing a single dose of NWT-03 on systolic and     diastolic blood pressure and endothelial function in a similar population.   "
86932|NCT02148185|"     The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303     in subjects with Crohn's disease.   "
87931|NCT02135120|"     The purpose of this study is to determine whether intrathecal morphine (ITM) alone or its     combination with peripheral nerve blocks (PNB) provides better analgesia for patients     undergoing total knee arthroplasty (TKA).   "
86923|NCT02148302|"     Epidermal grafts are believed to promote healing by two mechanisms: graft take and the     promotion of wound healing through the delivery of growth factors and the essential elements     of tissue repair and wound healing.28 This study is intended to establish the superior     effectiveness of epidermal grafting and multi-layer compression over that of multi-layer     compression alone, in the treatment of venous leg ulcers.      Millions of Americans are afflicted with painful, open, draining sores on their lower     extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of     circumstances these ulcers require weeks or months to heal. Not uncommonly wound care     specialists see patients who have suffered for years or faced amputation of the limb as their     only option to alleviate the pain.      Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However,     roughly half of patients suffering from venous ulcers will require advanced therapy.     Epidermal grafting has been a reconstructive option for decades; however, to date there has     not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting     System permits the harvesting of epidermal blister grafts at the patient's bedside without     the need for anesthesia. The grafts can be easily transferred to the wound bed. In case     studies, epidermal grafting appeared to be effective in reducing wound size and accelerating     closure of venous leg ulcers.   "
86924|NCT02148289|"     The acute consumption of dietary nitrate has been shown to improve exercise capacity in     athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients     have reduced exercise capacity, The investigators hypothesized that acute nitrate     consumption, in the form of beetroot juice, might increase incremental shuttle walk test     (ISWT) distance in COPD subjects.   "
86925|NCT02148276|"     This two-phased project will develop a comprehensive, audio computer assisted     self-administered interview social harm questionnaire (ACASI-SHQ) that will allow researchers     to more easily identify and monitor social harms experienced by substance abusers     participating in HIV-related trials. The ACASI-SHQ will (1) reduce the likelihood of socially     desirable responding, (2) include items with high levels of specificity to increase the     likelihood of identifying social harms (construct validity), and (3) utilize a self-interview     format that will increase the likelihood of its adoption by HIV researchers. The     investigators will then evaluate its feasibility, acceptability, and preliminary utility and     construct validity in an ongoing HIV-related trial.   "
86977|NCT02147600|"     The main goal of this study is to determine optimal cut-off values of adalimumab trough     levels corresponding to good clinical response. Determination of these values is necessary to     compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to     serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective     of this study is to further detect and quantify AAA and to correlate them with adalimumab and     clinical response in a real life setting cohort of psoriatic patients.   "
86978|NCT02147587|"     This study will evaluate immune response following administration of zoster vaccine in     subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5     mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.   "
86926|NCT02148263|"     Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is     common practice for practitioners to educate their patients to gradually increase their     contact lens wear time over their first few days of use; however, there is no scientific     basis in the literature for this practice. This study will compare the ocular health and     comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with     increasing wearing time versus those who immediately start full-time wear (eight hours or     more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue     Oasys) for two, four, six, eight, and eight or more hours on the first, second, third,     fourth, and fifth days, respectively. The other group will be instructed to wear the same     contact lenses for eight or more hours per day, starting with the first day of wear. Both     groups of subjects will have their eye health and comfort evaluated at baseline, one, and two     weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log     of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear     and take care of contact lenses. They will also receive a prescription for contact lenses at     the conclusion if they wish to continue wearing the study contact lenses.   "
86927|NCT02148250|"     The purpose of this study is to learn more about how U500 regular insulin can be effectively     be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take     U100 insulin, but if they require large doses (such as >150 units a day) they may experience     pain at this site of injection and the absorption of the insulin is unpredictable, thereby     leading to poor glucose control. To overcome these problems, doctors sometimes switch to a     more concentrated form of insulin called U500 insulin. U500 is five times as concentrated as     U100 insulin and therefore delivers an equivalent dose of insulin in much lesser volume.     However, how to best use U-500 insulin is not certain. The investigators are not really sure     how long a given dose is effective in patients who require large doses (>150 units of U100     insulin), so are not sure of how often the drug should be administered. In this study, the     investigators will determine how effective two different doses of U-500 regular insulin (100     U and 200 U) are in lowering blood sugar and how long these two doses last. This information     will help doctors develop better treatment plans for patients with type 2 diabetes.   "
86928|NCT02148237|"     This study is to determine preliminary effects of home-based individual breastfeeding     consultation with and without cash incentives to increase breastfeeding (BF) duration among     low-income Puerto Rican mothers enrolled in a Special Supplemental Nutrition Program for     Women, Infants, and Children (WIC).   "
86929|NCT02148224|"     Glycemic index concept is widely used to determine impact of a food to blood glucose.     Although the previous studies showed that glycemic index did not seem to be related with     subject-specific factors, currently several studies found conflicting results on the     relationship of subjects' characteristics and glycemic index values. This study aims to     determine whether body composition parameters, as subject-specific factor, correlate with     glycemic index values.   "
86930|NCT02148211|"     The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy     outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline     (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval,     Fluarix Quadrivalent and FluLaval Quadrivalent.   "
86933|NCT02148172|"     While surgical anterior cruciate ligament reconstruction (ACLR) of the knee restores passive     stability, studies are showing consistently poor long-term outcomes. Unusually high risks of     early-onset osteoarthritis and re-injury, and low rate of return to sport following ACLR all     seem to be related to a chronic tendency to land stiff-legged from a jump or hop, which     itself may be due to fear of re-injury. Decreased knee bending for force absorption     simultaneously decreases performance level and increases risk for injury and arthritic     changes.      The purpose of the proposed study is to compare a current best-practice plyometric training     program to one utilizing body weight support to increase repetition and improve performance     in the initial phases. The investigators hypothesize that we will see larger improvements in     absorptive capacity of the knee and better confidence in activity immediately following body     weight support training, as well as improved retention of training effects after a two-month     period.   "
86934|NCT02148159|"     Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid     weight loss negatively impact on physical functioning, quality of life, and overall survival.     Patients will be randomly assigned into two groups. An intervention with acupuncture may slow     down or stop the progression of cancer-related anorexia and weight loss.   "
86935|NCT02148146|"     This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat     emulsion in the treatment of liver disease associated with prolonged use of intravenous     nutrition.   "
86960|NCT02147821|"     This prospective randomized controlled trial will examine the efficacy of reducing the number     of chest tubes used in the postoperative cardiac surgery patient. Typically used are three     chest tubes - two in the mediastinum and one in the pleural space, if opened. The     investigators propose that removal of the pleural tube will not impact the rates of     clinically significant pleural effusions post cardiac surgery. Patients will be randomized     into two groups - one receiving the standard three chest tubes (standard), and the other     receiving only mediastinal drains (experimental). The primary outcome will be rates of     post-operative pleural effusions as determined by defined interventions, including insertion     of a chest tube, thoracentesis, or return to the operating room for primary evacuation of     pleural effusion or hemothorax. Secondary outcomes include length of hospital stay, length of     mechanical ventilation, postoperative respiratory status, and presence/size of pleural     effusions, as well as readmission for pleural effusion.   "
86961|NCT02147808|"     This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics     of midazolam in healthy male and female subjects.   "
86936|NCT02148133|"     This is an open-label, non-randomized, phase II study to assess the efficacy and safety of     eltrombopag in Japanese moderate or more severe aplastic anemia (AA) subjects with a platelet     count <30,000/ microliter who are refractory to anti-thymocyte globulin (ATG)-based     immunosuppressive therapy (IST), who have relapsed after ATG-based IST, or who are ineligible     for ATG-based IST.      Eltrombopag is expected to improve trilineage blood cells and decrease transfusion frequency     based on the result from the previous study in patients with severe AA. This study will use     the hematologic response rate, defined as the proportion of subjects showing improvement in     at least one of the three blood cell lineages or a decrease in blood transfusion volume, as     the primary endpoint.      Twenty patients will be enrolled in the study. Treatment with eltrombopag will be started at     25 milligram (mg)/day and increased by 25 mg/day every 2 weeks according to the platelet     count up to 100 mg/day. Response assessment will be performed at 3 months after starting the     study treatment (Week 13). Subjects in whom the treatment is assessed as effective will be     continued with the study treatment. Subjects in whom the treatment is assessed as effective     (when meeting any of the response criteria) at 6 months after starting the study treatment     (Week 26) may enter the extension phase and continue the treatment with eltrombopag. The     primary endpoint is the hematologic response rate at Week26.   "
86937|NCT02148120|"     The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator     effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535     NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic     patients.   "
86938|NCT02148107|"     It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics,     safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to     support the further clinical development of this LTA4H-inhibitor. Special emphasis will be     given to detect potential effects of BI 691751 on heart rate.   "
86939|NCT02148094|"     Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and     consistent condom use is an effective means of preventing HIV transmission, many FSWs have     difficulty insisting on their use. Alternative HIV prevention options are needed for FSWs who     are unable to correctly and consistently use condoms with their clients or regular partners.     Oral pre-exposure prophylaxis (PrEP) may be an important tool to fill this critical     prevention gap, and a demonstration project is required to assess the impact and feasibility     of the use of PrEP as an HIV prevention intervention among most at risk FSWs in India.      The proposed project will take place at two sites in India and will assess the use of a risk     assessment tool to identify FSWs who would most benefit from PrEP, collect information about     the reasons why FSWs choose to accept or decline PrEP, evaluate two different PrEP delivery     strategies (weekly clinic pick-up or home delivery by peer educators every second day),     monitor adherence to and discontinuation of PrEP, and evaluate unintended consequences of the     use of PrEP in these communities (e.g. reduction of condom use, drug side effects or adverse     events, social harms or resistance). To ensure the safety of study participants, a community     advisory board will be set up and will meet regularly to inform study staff of any concerns     that the community may have related to the study, so that the study staff can respond in a     timely manner. A data safety and monitoring board will also be established to monitor     participant safety.   "
86999|NCT02147314|"     This evaluation will evaluate a new system from YOFiMeter, known as YOFiLife Blood Glucose     Monitoring System with YOFiMeter glucometer. YOFiLife includes a web- based data system known     as the Web Portal and smart phone apps for the iPhone and Android. The new YOFiMeter is     similar to other glucometers with the exception of built in test cassettes, lancet cassettes     with enhanced communications and data reviewing options.      This evaluation will also collect data from a YSI 2300 Stat Plus Glucose Analyzer reference     glucometer. The YSI 2300 Stat Plus Glucose Analyzer will be used as the gold standard with     all results compared to the YSI results.   "
86940|NCT02148081|"     When children suffer from a critical-illness, the investigators focus on resuscitating and     saving lives. Once these children leave the pediatric intensive care unit, very little is     known about what happens to them - how long it takes for them to recover, how families cope,     and what factors that impede their recovery. The specific objective of this research project     is to evaluate how children and their families recover after a critical illness.      Research Hypotheses: Following a critical illness in children, 1) the rate and degree of     health and functional recovery is influenced by the following factors: age, pre-admission     co-morbid status, critical illness severity, discharge functional status, and time to     initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and     health-related quality-of-life (HRQoL).   "
86941|NCT02148068|"     Obesity is an important public health issue worldwide. In the United States, the percentage     of overweight and obese adults increased from 47 and 15%, respectively, to 69 and 36% in the     last 40 years. Medically supervised attempts at weight loss are fraught with failures and     recidivism. Surgical approaches to this important issue are both durable and effective. The     gold standard approach to the surgical treatment of obesity and the attendant medical     comorbidities is the laparoscopic roux-en-y gastric bypass (RYGB) and the laparoscopic sleeve     gastrectomy (LSG). The mechanisms by which these two operations work and the associated side     effects are not completely understood. It is established that the RYGB induces changes in     both the fatty tissue mass (FTM) and lean body mass (LBM) post-operatively. This is     associated with decreases in bone mineral density, basal metabolic rate, and potentially the     ability to maintain weight loss. There is only incomplete information on the influence that     the LSG has on body composition. This study proposes an evaluation of the changes in body     composition that occurs following these two disparate operations. Using serial measurements     by the BodPod and collecting information on the patients' dietary intake, exercise habits and     comorbidity resolution, this study will help to better define the influence that the LSG has     on body composition. It is hypothesized that the addition of a malabsorptive component will     result in increased speed weight loss and overall weight loss which will have a negative     impact in the preservation of lean tissue mass for the patient. This information can then be     used by bariatric surgeons to better cater the surgical procedure and post-operative plan to     the patient's body make up and medical comorbidities.   "
86962|NCT02147795|"     -  This epidemiological trial will determine whether the implementation of a PBM program is          safe and effective in terms of clinical outcome compared to a pre-implementation cohort        -  Primary endpoint is a composite outcome comprising in-hospital myocardial infarction,          stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge          from hospital in patients before and after implementation of the PBM program.        -  Secondary endpoints are the length of stay on the intensive care unit, total hospital          stay and the quantitative utilization of allogeneic RBC units, platelet concentrates,          other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and          cell saver systems during hospital stay.        -  The primary aim is to prove non-inferiority of the intervention (PBM) group when          compared with the control group stratified by center.   "
86942|NCT02148055|"     Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and     psychologically painful for the couple and the healthcare team. In this difficult context, it     is essential to understand the etiology of death to guide the management of subsequent     pregnancies. Among the investigations, foetopathologic examination is essential, but the     examination of the brain is not possible in more than half of the cases due to the cerebral     maceration due to the incompressible delay between death and expulsion.      The use of MRI as a diagnostic tool fetal post- mortem  virtual autopsy  performed before     expulsion of the fetus is interesting because it would permit to obtain a macroscopic     examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a     normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI     abnormalities are found , it will not only guide the foetopathologic review, but mainly to     guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the     couple would be better than autopsy which is often refused by the couple in this difficult     psychological context.      In this study , MRI will be given in addition to conventional autopsy in the painful waiting     time between the time of diagnosis of death and expulsion without delaying care . If this     study is validated , MRI may be systematically proposed in this indication or alternative to     autopsy when it will be refused by the parents.   "
86943|NCT02148042|"     Anorexia nervosa is a chronic mental health condition characterized by maladaptive food     consumption (i.e., hypophagia) and distorted body image. There is substantial evidence of a     phenotypic overlap between anorexia nervosa and anxiety disorders, as well as data suggesting     the two share a common genetic pathway. Despite these findings, little research has examined     fear conditioning among individuals with anorexia nervosa, and no research has examined     whether individuals with anorexia nervosa have a propensity to overgeneralize conditioned     fear stimuli, one of the more robust fear-conditioning markers of anxiety disorders. The     current study assesses generalization of conditioned fear with fear-potentiated startle: the     cross-species enhancement of the startle reflex when an organism is in a state of fear.     Animal data, as well as an emerging literature in humans, tightly links fear-potentiated     startle to the amygdala-based fear circuit. Thus, evidence of overgeneralized     fear-potentiated startle in anorexia nervosa would link this eating disorder to     hypersensitivity of the fear circuit and could inform the development of novel pharmacologic     and psychological treatments for anorexia nervosa based on treatment models used in the     anxiety disorders literature.   "
87000|NCT02147301|"     TACE is frequently offered to patients with baseline hepatic dysfunction with the purpose of     diminishing hepatic tumor burden while patients await transplantation. Without this     therapeutic measure, disease may progress beyond UNOS T2 criteria required for organ     allocation.      The purpose of the study is to determine whether transarterial chemoembolization using     doxorubicin-eluting beads (DEB-TACE) can be used safely and effectively to treat patients     with liver-only hepatocellular carcinoma (HCC) and baseline hepatic dysfunction.   "
87932|NCT02135107|"     The purpose of this study is to assess the efficacy and safety of E3810 10mg once and twice     daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.   "
86944|NCT02148029|"     Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs     progress to chronic post-clot problems resulting in significant disability, loss of     productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the     primary cause of post-clot problems. Veins with early clot breakdown have a lower incidence     of reverse flow. The investigators have observed that clot breakdown is enhanced by increased     blood flow and that moderate arm and leg exercise result in increased venous blood flow.     Hence, the investigators predict that a supervised exercise program in patients with deep     vein clots could increase leg vein blood flow, accelerate clot breakdown, and decrease the     risk of post clot problems. The primary hypothesis is that increased blood flow across the     clot (induced by supervised exercise) will increase clot breakdown and decrease severity of     post clot problems. The investigators are conducting a randomized clinical trial of standard     therapy compared to progressive exercise training in patients with leg deep vein clots.   "
86945|NCT02148016|"     Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor     tissue has prevented many patients from regaining vision. Additionally, refractive error such     as myopia is a major cause of impaired visual function worldwide. Although refractive error     is correctable by procedures that modify the refractive power of the cornea, these procedures     often weaken corneal integrity and have risk of complications. This study aims to evaluate     the safety and efficacy of corneal surface epithelium repair and regeneration in the     treatment of corneal surface diseases and refractive error using autologous limbal stem cell     transplantation.   "
86946|NCT02148003|"     Chronic lower back pain (CLBP) is a significant health care issue in the United States and     the world. CLBP contributes to decreased quality of life, decreased function and increased     utilization of health care resources. The causes of CLBP tend to be multi‐factorial.     Arthropathy of the lumbar facet joints is thought to be a common etiology (15‐45%).     Radiofrequency Ablation (RFA) of the medial branch nerve of the facet joint is a     well‐established treatment modality used to decrease facet joint pains. However, a wide range     of temperature is being used (70‐90 degrees Celsius). In addition, the optimal temperature     that provides the best patient outcomes with the least side effects is not well established     in the pain management literature.      This study will determine if lumbar facets medial branches RFA at 90 degrees Celsius provides     more overall pain relief (i.e., percent of improvement), when compared to ablation at 80     degrees Celsius with no additional adverse events. Furthermore, ablation of the lumbar facets     nerve supply at 90 degrees Celsius will provide better improvement in the functionality     level, general mood and quality of life as measured by VAS ( Visual Analog Scale) pain score,     Pain Disability Index (PDI), McGill Pain questioner scores and Beck Inventory (BI) scores as     those receiving the ablation at 80 degrees Celsius. Also, it is associated with less opioid     consumption, no additional unwanted adverse events and/or complications along with less need     to repeat RFA procedure over one year period.   "
86947|NCT02147990|"     The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The     trial is open-ended, which means patients will continue to take rociletinib until the study     doctor determines it is no longer beneficial for them.   "
86963|NCT02147782|"     Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone     loss, which is called renal osteodystrophy. Most of the previous studies focused on bone     metabolism of patients in late stage of chronic renal insufficiency, especially those with     chronic dialysis. In this study, bone metabolism of patients in different stages of chronic     renal insufficiency will be observed to reveal the mechanism of development of renal     osteodystrophy and provide clues for early intervention on renal osteodystrophy.   "
87041|NCT02146768|"     Low-dose-contrast CCTA can effectively and safely assess the aortic valve apparatus, and     effectively direct the trans-catheter heart valve (THV) size selection by providing accurate     annulus sizing, and provide adequate pre-procedural risk-stratification guidance for     TAVR/TAVI.   "
86948|NCT02147977|"     Background: End Stage Renal Disease (ESRD) patients have an extremely high mortality and the     leading cause of death is cardiovascular disease which accounts for 50% of all deaths. It is     estimated that about one third is due to arrhythmias. Previous studies reveal a higher risk     of various arrhythmias in dialysis patients but the prevalence is uncertain. Atrial     fibrillation is the most common arrhythmia among patients with ESRD. The arrhythmia is often     asymptomatic, but the risk of stroke increases dramatically and the annual mortality doubles.     Autonomic cardiac dysfunction is often seen in patients with ESRD, and this is expressed by     attenuated Heart Rate Variability (HRV) which is a measure of the variation in the time     interval between heart beats. Attenuated 24 hours HRV is associated with an increased risk of     sudden cardiac death in the general population and among patients with ESRD. N-3     polyunsaturated fatty acids (PUFAs) in fish or fish oil supplements have been shown to     increase HRV and reduce the risk of various ventricular and supraventricular arrhythmias in     some but not all studies, but this effect has only been sparsely investigated in the high     risk patients with ESRD, who has a very low intake of n-3 PUFAs.      Objective: The purpose of this study is to investigate the effects of n-3 PUFA     supplementation on HRV and arrhythmias in dialysis patients.      Hypothesis: n-3 PUFA supplementation increases 24 hours HRV in dialysis patients. n-3 PUFA     supplementation reduces the level of Supraventricular tachycardia, premature atrial complexes     (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients.      Design: Randomized double-blind, placebo controlled trial      Study participants: 140 dialysis patients at Aalborg University Hospital and Vendsyssel     Hospital, Hjørring in Denmark.      Inclusion time: Summer 2014 to Fall 2015      Methods: The patients are allocated to 3 months treatment with supplements of 2 g n-3 PUFAs     or placebo (olive oil). The following data are registered at baseline and after 3 months     treatment: Demographics and medical history, Standard ECG-12, blood pressure, blood samples,     48 hours ambulatory ECG Holter recordings, Intake of n-3 PUFAs (assessed by questionnaires     and blood measurements).      Perspective: A positive result of this study might make it possible to achieve a reduction in     arrhythmias and mortality in these high risk patients by a cheap and well tolerated     nutritional supplement.   "
86949|NCT02147964|"     The purpose of this investigational drug study is to determine how much male hormone,     testosterone, is needed to maintain sperm production in the testis.   "
86950|NCT02147951|"     Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c     Melanoma.   "
86952|NCT02147925|"     The aim of this study is to explore the effectiveness of liraglutide combined with metformin     in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared     to sitagliptin and insulin glargine in combination with metformin.   "
87321|NCT02143128|"     Using clinical experience and brain storm method the investigators picked up and     digitalized information about mental, postoperative nausea, vomiting and pain status at the     rest and during mobilization in so called Efficacy Side-effect Score (ESS) Depending on     expression of patient's complaints, all mentioned above clinical features are scored up from     0 to 10-15 and summarized in the total score. This score is now to be validated and     re-developed to be used as a tool for improving safety and quality of postoperative care.   "
86953|NCT02147912|"     Background:      Several clinical studies show high rates of anxiety and depressive disorders in Chronic     Obstructive Pulmonary Disease (COPD), that suggest common underlying pathogenetic mechanisms     of COPD and depressive disorders. The aim of this study is to evaluate the effects of aerobic     exercise, proposed in the context of pulmonary rehabilitation, in a sample of COPD depressed     patients without psychopharmacological treatment, through the correlation of some     psychopathological variables and physical/pneumological parameters.      Methods:      The investigators have designed an observational longitudinal trial. The trial will be     prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on     depressive symptoms in 154 patient affected by COPD and depression, assessed by Hamilton     Depression Rating Scale (HDRS). The investigators will also monitor anxiety, quality of life     and neurocognitive function.      Outcome measures:      The investigators compare the variation of HDRS total score, as primary outcome measure, in     two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status;     age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic     exercise intervention.      Statistical analysis:      All tests are two-tailed and a p value 0.05 was considered significant. The difference     between the two groups will be evaluated with Student's T test for normally distributed data,     and with Mann-Whitney's U test, for those with not normal distribution. The normality of     distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations among the     variables under evaluation will be assessed by Spearman r correlation. Variables will be     compared using the Chi-squared test or Fisher exact test for categorical variables.      Discussion:      There is a strong correlation between physical activity and mental health. Several data have     suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and     to psychotherapy, on reducing depressive symptomatology. The goal of our study is to propose     an effective intervention to reduce the risk of severe depression in this special population,     evaluating the variation of HDRS total score after the aerobic exercise intervention.   "
86954|NCT02147899|"     The purpose of this research study is to test the safety and effectiveness of the oral     investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.   "
86955|NCT02147886|"     -  This is an exploratory, randomized, parallel-group, dose escalation and dose-controlled          study without a placebo arm.        -  Eligible patients will be randomized in a 1:1 ratio (double-blind) to receive Cabaletta          in 2 doses, once weekly for 22 weeks (total of 24 weeks of treatment).   "
86956|NCT02147873|"     This is a randomized double blind placebo controlled study of azacitidine with or without     birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or     myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and     mechanistic studies support that azacitidine may modulate pathways that enable     birinapant-mediated anti-tumor activity.   "
86957|NCT02147860|"     The overall aim of this proposed research is to determine the safety, feasibility and     efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in     children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting.     This will be addressed in two parts: 1) An in residence, outpatient study to determine safety     and feasibility of the DiAs during 72 continuous hours of day and night glucose control; and     2) Camp studies planned for the summer of 2014 with randomization to either full closed-loop     or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps.   "
86958|NCT02147847|"     Hearing in noisy environments is a perceptual problem that is ubiquitous in modern     industrialized societies. This particular listening context offers a particular challenge to     individuals living with hearing impairment (30 million in US alone) even after treatment with     hearing aids or cochlear implants. The ability of the brain to extract regularities from the     environment and suppress distracting information can be improved with intensive cognitive     training. The investigators will test whether the hearing in noise abilities of adults living     with hearing impairment can be improved with a cognitive training paradigm.   "
86959|NCT02147834|"     To determine if ranolazine improves angina symptoms at 4 months compared with placebo among     patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on     the Fractional Flow Reserve (FFR) measurement.   "
86964|NCT02147769|"     Premature infants are at high risk for variations in blood pressure and oxygenation during     the first few days of life. The immaturity of the premature brain may further predispose     these infants to death or the development of neurologic problems. The relationship between     unstable blood pressure and oxygen levels and brain injury has not been well elucidated.      This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive     oxygen-measuring device, to identify preterm infants at highest risk for brain injury or     death.   "
86967|NCT02147730|"     Regional anesthesia techniques, with administration of local anesthetics for neuraxial or     peripheral route are now playing a central role in modern anesthesia and in particular in the     control of postoperative pain. There are many review and meta-analyzes suggesting that a good     pain control, and specifically loco regional analgesia, may improve the outcome of patients     undergoing surgery.      The control of acute post-operative pain is not the only challenge to be paid by     anesthesiologists, because there is still much to be understood in relation to persistent     post-surgical pain (PPP), and about the degree of influence that regional anesthesia plays in     complete long-term functional recovery of patients.      From the pathophysiological perspective there is not a precise definition of the mechanisms     and risk factors that determine the onset of the persistent pain after surgery, but, more in     general, it seems to be related to a malfunction of the mechanism of secondary hyperalgesia.      Regional anesthesia could play a key role, as the main determinant of chronic pain is acute     post-operative pain. The techniques of regional anesthesia exert a powerful block at the     peripheral level, potentially preventing the progression of central pain and the persistence     of stimuli that can reach the central nervous system. In addition, during surgery, these     techniques can reduce the metabolic alterations and the triggering mechanisms of local and     systemic pro-inflammatory mediators' release.      Few perspective studies exist about the influence of regional anesthesia on long-term outcome     and persistent pain after surgery.      The objective of the investigators study is to assess in a prospective fashion the role of     regional anesthesia/analgesia technique in preventing (or not) persistence pain occurrence     after surgical interventions which are mostly associated to pain persistence, and understand     if regional anesthesia provides advantages in other post-surgical outcomes.   "
86968|NCT02147717|"     Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the     effect of laser acupuncture in the treatment of perioperative pain during tracheal suction     after patent ductus arteriosus ligation in preterm infants.   "
87001|NCT02147288|"     The specific aim of this study is to improve post-operative wound care in the morbidly-obese     body-contouring patient population following massive weight loss undergoing either     panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall     reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal     matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the     effectiveness of standard closed-suction drains versus the immediate application of     continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to     non-compressible drains. Additionally, we aim to demonstrate increases both in     cost-effectiveness and quality of life in these patients with the use of the NPWT wound care     apparatus.      Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound     complications in comparison with conventional closed suction drains when used in patients     after massive weight loss undergoing body-contouring procedures (panniculectomies alone and     formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with     acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty.      Hypothesis 2 Although initially more costly than traditional closed suction drains, the use     of continuous negative pressure devices will in the long-term result in lower total health     care costs in the above-stated patient population due to a decreased need for additional     procedures and/or clinical management, including surgical interventions, hospital admissions,     administration of antibiotics, multiple follow-up office visits, and chronic wound care.      Hypothesis 3 Better quality of life is associated with the use of continuous negative     pressure devices compared to closed suction drains in these patient populations.   "
86969|NCT02147704|"     It has been known that the blood pressure lowering effect of angiotensin receptor antagonists     (ARBs) and angiotensin converting enzyme (ACE) inhibitors is impaired in patients on high     sodium intake. There was an enhanced blood pressure lowering effect of ACE inhibitor when     sodium intake was restricted or diuretics were added.      The reason is partially explained by sodium sensitivity or low rennin activity in high sodium     intake. However, the exact mechanism of sodium intake dependency is not clearly understood.      In a recent study, an ARB, candesartan was revealed to have sodium intake dependency, showing     lower plasma concentration when subjects were on high sodium intake compared to on low sodium     intake. However, plasma concentration of another ARB, valsartan and an ACE inhibitor ramipril     was not changed depending on the sodium intake.      The strongly suggested mechanism is the involvement of transporter P-glycoprotein (Pg-P). the     function and expression of Pg-P are modified by genetic polymorphism of multidrug resistance     1 gene.      Although the transport mechanism of Fimasartan from gut is not fully understood, it has been     known that the multidrug resistance 1 is not involved. Thus, the pharmacokinetic and     pharmacodynamic property of fimasartan is expected not to be affected by the status of sodium     intake.      The present study is designed to investigate whether the pharmacokinetic and pharmacodynamic     property of fimasartan is changed depending on the sodium intake.   "
86970|NCT02147691|"     The pilot study will investigate whether combination treatment of Finacea 15% Gel and     Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in     treating both the papules/pustules and erythema associated with rosacea.   "
86971|NCT02147678|"     To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and     cognitive function in elderly patients   "
86972|NCT02147665|"     This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control of     the human cardiovascular system. Hookah smoking is known to transiently increase blood     pressure and heart rate while decreasing heart rate variability suggesting - but not proving     - sympathetic mediation. Here the investigators will directly measure the acute effects of     Hookah smoking on sympathetic nerve activity with microneurography (intraneural     microelectrodes) and quantify associated regional changes in vasomotor tone.   "
86973|NCT02147652|"     Symptoms of agitation include abuse or aggressive behaviour toward self or others,     appropriate behaviour performed with inappropriate frequency, or behaviours that are     inappropriate according to social standards. In the later stages of dementia agitation can     contribute significantly to patient distress and caregiver stress, and has been associated     with poor quality of life. Previous research studies have shown some evidence that     personalized music played in daily care situations reduces agitation. The purpose of this     study is to evaluate the effects of personalized music therapy via headphones on agitation     during hygiene care (grooming).      This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto     Rehabilitation Institute. The study would take place over the span of 2 weeks and would     involve listening to personalized and either non-personalized or no music during daily     hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained     will remain confidential.   "
86974|NCT02147639|"     This study is intended to build on a growing body of literature showing a blood flow     abnormality in patients with Becker muscular dystrophy. The investigators' laboratory     recently showed that this blood flow abnormality could be corrected by a single oral dose of     the drug Tadalafil (also known as Cialis). The investigators now wish to replicate these     exciting results using a common nitric oxide donor (sodium nitrate).   "
86975|NCT02147626|"     This study will compare two arms in a randomized clinical trial of cardiovascular risk     prevention in women with a history of preeclampsia. The first arm will provide postpartum     patients and their clinicians with the American Heart Association's (AHA) Class I Lifestyle     Recommendations for women with a history of preeclampsia. The second arm will additionally     receive access to a customized patient-informed online program with modules on how to achieve     the AHA recommendations for diet, activity and weight management.   "
86976|NCT02147613|"     Heart failure is a major health concern and is the leading cause of hospitalization among     elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and     the estimated direct and indirect costs of treating heart failure are approximately $37.2     billion. Approximately 40% of those diagnosed with heart failure will have heart failure with     preserved ejection fraction (HFPEF). These individuals have significant restrictions in their     ability to carry out activities of daily living. Exercise training has been established as     adjuvant therapy in heart failure. Although exercise training guidelines for treatment of     heart failure with reduced ejection fraction (HFREF) are well established, no consensus     exercise guidelines exist for management of HFPEF. Aerobic and cardiovascular adaptations are     generally greater after high-intensity exercise training; interval-type exercise facilitates     this type of training because it allows for rest periods that make it possible for patients     with heart failure to perform short (e.g., 1-4 minutes) work periods at intensities that are     higher than would be possible during continuous exercise. High-intensity aerobic interval     training presents a unique, yet untested, therapeutic modality for the exercise training of     patients with heart failure with preserved ejection fraction. Pilot testing is warranted,     results of which may have important implications for reducing cardiovascular risk, increasing     short- and long-term quality of life and survival, and reducing healthcare costs in this     patient population. The investigators primary specific aim is to determine the efficacy of a     novel, high-intensity aerobic interval exercise training program for improving VO2peak (peak     oxygen uptake), endothelial function, and arterial stiffness in patients with HFPEF. The     investigators secondary aim is to determine whether the vascular changes are correlated with     the changes in VO2peak.   "
86979|NCT02147574|"     Purpose:      To evaluate the curative effect of Laparoscope Sub-total Colectomy with Anti-peristaltic     ileosigmoid anastomosis for the treatment of slow-transit constipation on the patients with     STC.      Methods and techniques:      The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with     anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related     status such as frequency of defecation, course of constipation, laxatives use condition the     condition of using laxatives, and changes in weight were investigated. Changes of defecation     and weight, periprocedural complications (wound infection, lung infection and intestinal     fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction,     wexner score of pre-operation and postoperation ect were investigated in follow-ups.   "
86980|NCT02147561|"     This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with     chronic migraine.   "
86981|NCT02147548|"     The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to     lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.   "
86982|NCT02147535|"     The purpose of this study is to determine whether differences in the gene coding for the     liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of     methylphenidate, a CES1 dependent drug.   "
86983|NCT02147522|"     Study Hypotheses (Ho) and Research Questions (RQ):        -  Ho1. AHH will significantly improve patient depression treatment acceptance/adherence          and depression symptoms vs UC at 6 and 12 months post-baseline.        -  Ho2. A Helping Hand (AHH) will significantly improve and sustain patient self-care          management in Self-Efficacy for Managing Chronic Disease (SEMCD) and Quality of Life vs          UC at 6 and 12 months post-baseline.        -  RQ1. What is the association between depression symptoms and concurrent chronic illness          self-care management over time by group?        -  RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic          appointment-keeping?        -  RQ3. Will patient care satisfaction and reported barriers to self-care management vary          by study group?        -  RQ4. What factors are identified via qualitative assessments of patients, promotoras,          Department of Health Services (DHS) medical and social work providers, and DHS          clinic/organizational leadership regarding satisfaction with, sustainable uptake of, and          suggested modifications of the AHH promotora delivery model?        -  RQ5. What potential technology applications would enhance promotoras delivering          patient-centered self-care training and resource navigation, communicating and          integrating care with DHS, and disseminating AHH?   "
86984|NCT02147509|"     The purpose of this study is to evaluate the therapeutic effect and safety of therapeutic     bandage contact lenses treating dry eye caused by Sjögren's syndrome.   "
86985|NCT02147496|"     The purpose of this study is to examine the effects of fluid dairy products on blood glucose     and insulin, satiety and energy intake in normal weight and overweight/obese children in the     age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of     isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F.     yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later     on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and     tropical punch consumed before and with a pizza meal 60 min later on food intake, blood     glucose, and appetite hormone response.   "
86986|NCT02147483|"     We propose to conduct a pilot study that will examine the utility and mechanisms of     Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and     physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR     diagnostic criteria for alcohol dependence within the past year but have abstained from     drinking for the last thirty days. MBRP is designed to improve one's ability to self-regulate     emotions, thoughts and physical states, thus reducing the need to alleviate associated     discomfort through substance use. Participants assigned to the intervention group will     receive an 8-week training course of MBRP over a period of nine weeks; participants assigned     to the Treatment As Usual (TAU) group will continue treatment as usual, which includes     utilizing their own effective strategies to refrain from alcohol use. All participants will     be assessed for pretreatment severity of psychological abuse/trauma as well as pre and     posttreatment psychosocial functioning (e.g., alcohol consumption, symptoms of depression and     anxiety, emotion regulation/coping). The outcome of treatment will be evaluated using a)     Timeline Followback drinking data and b) self-report ratings of acquisition of MBRP skills     (e.g., state/trait mindfulness, acceptance and awareness, and perceived stress) and     depressive and anxiety symptom severity. We hypothesize that participants who receive MBRP     training will demonstrate greater acceptance and awareness, reduced cravings, and have a     lower likelihood of relapse than participants in the TAU group. It is also expected that MBRP     participants will demonstrate greater improvements on psychological measures of depression,     anxiety, emotion regulation and coping, and show less perceived stress and physiological     arousal to stress compared to TAU participants. Finally, little is known about which types of     individuals are most likely to benefit from MBRP. Thus, secondary analyses will help to     clarify for whom MBRP may be most effective.   "
86987|NCT02147470|"     Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in cirrhotic     patients and has a one month survival rate of 50% and a 3 month survival rate of 20%. The     leading theory behind HRS is selective vasoconstriction of renal vasculature in the setting     of decreased systemic vascular resistance. Patients with liver cirrhosis suffer from a large     degree of third spacing in the form of peripheral edema and ascites. In addition treatment     with multiple drugs, including diuretics puts these patients at higher risks of prerenal AKI     and ischemic acute tubular necrosis (ATN). AKI occurring due to HRS, prerenal AKI and     ischemic or nephrotoxic ATN have different pathophysiologic mechanisms and are treated     differently with significantly different outcomes. While renal perfusion is expected to be     reduced in HRS and prerenal AKI, it is normal or increased in ATN. Prerenal AKI has the most     favorable prognosis among these pathologies and treatment simply consists of volume expansion     with blood, albumin, crystalloids or colloids. In clinical practice vasoactive agents such as     midodrine and octreotide are used to increase the tone of splanchnic vessels and to improve     renal perfusion. These interventions would not affect renal function in cases with ATN.     Unfortunately, the diagnostic criteria proposed by the International Club for Ascites (ICA)     for HRS are not specific and do not always exclude patients with other forms of acute kidney     injury. Therefore, availability of a simple diagnostic tool for measurement of renal blood     flow (RBF) at the bedside would be of great value in management of cases with cirrhosis of     the liver presenting with acute reduction in kidney function. However, currently, there are     no practical and simple tools available for this purpose.      Contrast enhanced ultrasonography (CEU) involves the intravenous injection of gas-filled     microbubbles to enhance the ultrasound image of the organs and mainly to assess tissue     vascularity and blood flow. We and others have used CEU to assess changes in RBF in response     to physiologic stimuli and therapeutic interventions. Here we propose a prospective, pilot     diagnostic study to validate the use of CEU, in assessing RBF in cirrhotic patients with AKI,     and to assess the utility of CEU to differentiate between causes of AKI in cirrhotic     patients.      Our hypothesis is that CEU will show arteriolar vasoconstriction and decreased blood flow in     the renal cortex in patients with HRS which would not change in response to volume expansion.     On the contrary, patients with prerenal AKI will have reduced RBF which will increase after     volume expansion. Finally, those with ATN will not have a reduced RBF at baseline.      We plan to enroll 25 patients with liver cirrhosis and acute kidney injury who are admitted     to the University of Virginia hospital into the study.      CEU will be performed on all subjects to measure baseline RBF. CEU will be repeated in all     subjects within 24 hours after volume expansion with at least 1gm/kg of albumin (up to 100     gm/day) to assess a potential change. Hourly urine output and serum creatinine will be     monitored for potential renal response to the volume expansion as part of clinical care. For     the subgroup of subjects who receive treatment with combination therapy with albumin,     midodrine, and octreotide (AMO) RBF assessment with CEU will be repeated after at least 48     hours of receiving this combination. Renal response will be assessed by monitoring urine     output and serum creatinine monitored as part of clinical care. All subjects will have     measurements of fractional excretion of sodium (FENa) and urea (FEUrea) and urine microscopy     as a part of their routine clinical care (work up of AKI). The results of these tests and the     response to volume expansion will be used to categorize subjects into three categories of AKI     (HRS, prerenal AKI, ATN). Correlations between RBF and its changes between different     therapeutic interventions and renal diagnosis will be tested in this study.   "
86988|NCT02147457|"     Extreme preterm birth interferes with the development of the cardiovascular system. Both     macro- as well as microvasculature undergoes extensive, organ specific maturation. Under     normal fetal conditions, microvascular growth drives renal development and continues until     34-36 weeks of gestational age, while retinal vascular growth continues until term age.     Studies show that there is association between low birth weight and cardiovascular     dysfunction. According to the Barker hypothesis, this is due to nutritional shortage. In     extreme preterm birth cases, this growth restriction is observed in neonatal life.      In adult life, this suboptimal growth is associated with impaired renal and (micro)vascular     function, hypertension, glucose intolerance and cardiovascular disease. According to the     Brenner hypothesis, disrupted renal development results in hyperfiltration and hypertension,     a process that subsequently promotes itself and leads to renal impairment. We will     investigate macro- and microvasculature in different organs, including eye, kidney, heart and     sublingual mucosa in former preterm infants, now aged 8-13 years old and age-matched     controls.      The expectation is that the results of this project will identify risk factors for     cardiovascular-renal disease in the adult life of former preterm infants compared to the     controls, while further analysis on mediators in neonatal life of this cardiovascular-renal     outcome may provide new information on perinatal risk factors.   "
86989|NCT02147444|"     The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely     rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical     practice.   "
86990|NCT02147431|"     This trial is conducted in Europe. The aim of this trial is to investigate the effect of     semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2     diabetes.   "
86991|NCT02147418|"     Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft     palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the rise     in the United States. Human papillomavirus (HPV) has been recognized in many of these     cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this     study, our goal is to develop a new test that can detect certain HPV proteins in the blood or     saliva to help improve detection of OPSCC.   "
87002|NCT02147275|"     The purpose of this study is to determine whether there is a significant decrease in cerebral     oxygen saturation in hypertensive patients undergoing major abdominal surgery and their     correlation with standard monitoring parameters.   "
87003|NCT02147262|"     The main objective of this study is to characterize the inflammatory proteins, gene     polymorphisms, and transcriptome profiles in patients with chronic atrophic dermatitis to     gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu     lato.   "
87004|NCT02147249|"     The main objective of this study is to characterize the inflammatory proteins, gene     polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better     insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that     could serve as biomarkers of disease activity.   "
86992|NCT02147405|"     Background:      - Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms     soon after starting HIV medications. Often these symptoms are caused by immune reconstitution     inflammatory syndrome (IRIS). Researchers want to study why and how people develop IRIS and     how best to prevent and treat it.      Objectives:      - To learn the causes and effects of IRIS,and how to best manage it.      Eligibility:      - Adults 18 and older with HIV and low CD4 counts,, about to start HIV medicines; or those     already taking HIV medicines with symptoms thought to be related to IRIS.      Design:        -  Participants not on ART will have screening blood tests for CD4 count, HIV viral load          and genetic testing.        -  After the screening blood tests and before starting HIV medicines., participants will          return for more than 1 visit for the following:      <TAB><TAB>- review of medical history<TAB>      <TAB><TAB>- physical and eye exams      <TAB><TAB>- blood, urine, and tuberculosis (TB) tests      <TAB><TAB>- electrocardiogram (EKG)      <TAB><TAB>- chest x-ray        -  apheresis: a blood drawing procedure where blood is removed from a vein, white blood          cells are separated and collected, and the rest of the blood is returned to the person          using another vein        -  - PET scan - a procedure where a small amount of radioactive material is injected in a          vein. The participant then lies on a table that slides into a scanner which takes images          of the body.      <TAB><TAB>- lymph node biopsy      <TAB><TAB>- stool collection by swab        -  After completion of the above, HIV medicines will be started.        -  Follow-up visits will be at 2, 4, 8, and 12 weeks after starting ART, then every 12          weeks. Some of the tests above may be repeated.        -  Participants already on HIV medicines who may have IRIS will be screened over a 4 week          time period to see if they really are experiencing IRIS. The screening process will          include all of the items listed above. Follow-up visits will be at Weeks, 4, 8, 12 and          then every 12 weeks.        -  The study will last 1 year for both groups but may be extended to 2 years (3 additional          appointments) for some participants.   "
86993|NCT02147392|"     Background:      - A protein called translocator protein may play a role in brain inflammation. Sometimes it     is present at higher levels in the lungs than in the brain. Researchers want to see if a drug     called [11C]ER176 can provide an image of this protein in the brain.      Objective:      - To test the ability of a drug to image a protein, and test how it is distributed in the     body.      Eligibility:      - Healthy adults over age 18.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests.        -  Participants will have a PET scan of the brain using [11C]ER176. It will be injected          through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery at          the wrist or elbow. Some participants will also have a lung scan.        -  For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped          scanner. A plastic mask will be molded to their face and head. They may be wrapped with          restraining sheets. The scan will last about 120 minutes. Blood may be taken during the          scan.        -  Blood and urine will be taken before and after the scan.        -  During another visit, participants will have an MRI scan of the brain. Participants will          lie on a table that slides in and out of a metal cylinder. A strong magnetic field and          radio waves will take pictures of the brain. The scanner makes loud knocking noises.          Participants will be given earplugs.        -  Some participants will have only a whole-body PET scan using [11C]ER176.   "
86994|NCT02147379|"     This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I     disorder (manic depression), who are in remission from an episode. Participants who show     cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on     to their current medication(s) or continue their usual treatment for 6 weeks. Participants     will have 3 clinical visits and 2 telephone appointments during the study. Given the     preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we     propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.   "
86995|NCT02147366|"     -  Hypertension is one of the leading risk factors influencing morbidity and mortality.          There is need for non-pharmacological management for the same. Music is known to reduce          anxiety and holds promise for non-pharmacological management of hypertension owing to          low cost, ease of administration and safety. The efficacy of music to reduce blood          pressure (BP) has not been established. Besides inconsistent findings, earlier studies          using music are frequently inconclusive from small sample size. The studies have not          examined the biomarkers of hypertension.        -  The purpose of this study was to evaluate the effect of Indian Instrumental music on          pre-hypertensives and stage 1 hypertensives subjects. Non-pharmacological intervention          improves the quality of life of hypertensives and music may serve as an adjunct therapy          along with standard management of hypertensives.   "
86996|NCT02147353|"     External Genital Warts (EGW) are the most common sexually transmitted disease associated with     more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of     EGW treatment. However, multiple sessions may be required with reported clearance rates     ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved     for three times daily application in immunocompetent subjects 18 years and older for the     treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by     sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with     immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy,     treating both clinical and sub-clinical lesions. For this study, the investigators used     sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect     with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also     anticipated that the sequential therapy with be safe.   "
86997|NCT02147340|"     This study has been designed to describe the use of Remote Patient Management (RPM) systems     equipped with sensors for the measurement of weight and blood pressure in an Italian health     care setting, verifying their efficacy and efficiency for the remote management of heart     failure patients with implantable defibrillators. Moreover, their ease of use and acceptance     by physician and patient will be assessed.   "
86998|NCT02147327|"     Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25     dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone     metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal     low vitamin D level is a well known problem for our country and the level was reported as <10     ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low     socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in     relation with several neonatal morbidities and maternal complications of pregnancy.   "
87322|NCT02143115|"     The goal of this study is to compare the findings of virtual (CT-colonography) with findings     of optical colonoscopies to determine if virtual colonoscopy is suitable for colorectal     cancer surveillance.   "
87323|NCT02143102|"     The investigators use MRI and/or CT to evaluate the extent, as well as, the structure,     composition, and functional aspects of atherosclerotic plaques in human carotid and femoral     arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular     beds as part of their routine clinical care.   "
87005|NCT02147236|"     To evaluate whether a structured social skills program, called Social Skills Development,is     superior to a wait list control group on measures of interpersonal interaction. The Social     Skills Development (SSD) is a 16-week, group intervention that uses activities and peer     tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum     Disorders.Following a diagnostic and social skills assessment,children are randomly assigned     to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered     SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability     of gains during the first 16 weeks.   "
87006|NCT02147223|"     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa     products, red wine, and tea, are associated with decreased cardiovascular mortality and     morbidity. Dietary interventional studies have corroborated this finding and showed that     flavanols can acutely and after sustained ingestion improve surrogate markers of     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event     in the development and progression of cardiovascular disease. The aim of the study is to     assess sex specific effects of cocoa flavanols on endothelial and vascular function in     healthy subjects.   "
87007|NCT02147210|"     The principal purpose is the study of the regulation of the expression of ephrin-B1 by     immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy     (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG     biopsy will be the experimental reference value.   "
87008|NCT02147197|"     This study will evaluate the superiority of ulipristal acetate vs. placebo for the treatment     of bleeding associated with uterine fibroids   "
87009|NCT02147184|"     Building on findings from animal studies, pediatric clinical trials, epidemiologic research     in adults, and on preliminary findings from the investigators' laboratory in children and     adolescents, this project aims to investigate whether selective serotonin reuptake inhibitors     (SSRIs), a group of widely-used psychotropics, are associated with impaired bone     mineralization in youths. Establishing such an association is a first step in a process that     would eventually involve developing preventative interventions. Identifying genetic factors     that place certain youths at higher risks for this side effect would ultimately allow     clinicians to tailor treatment to the needs and vulnerabilities of each youth, moving the     field closer towards individualized medicine.   "
87010|NCT02147171|"     Normal ageing affects vision as a result of preretinal and retinal changes. Photoreceptors,     the light sensitive cells in the retina, degenerate and the rods (responsible for night     vision) are most susceptible to damage with increasing age. Rod loss leads to poor vision in     the dark which increases the risk of accidents amongst the elderly. Macular pigment (located     in the photoreceptors)is thought to protect the retina and reduce the risk of age related     changes. Dark adaptation, mediated by the rods, slows down with age, and is also reduced in     AMD (age-related macular degeneration). Recent evidence suggests that lutein (the main     component of macular pigment) supplementation improves the dark adaptation deficit in AMD     subjects. Research into the effects of lutein in a normal human has not been previously     conducted. Since the older population is increasing, our aim is to firstly establish the     extent of night vision loss (using dark adaptometry) and secondly to examine the possibility     of slowing down or reversing this loss through lutein supplementation.   "
87011|NCT02147158|"     This study will evaluate the superiority of ulipristal acetate vs. placebo for the treatment     of bleeding associated with uterine fibroids   "
87012|NCT02147145|"     Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis:     Patient compliance with a GIST surveillance program will be low.      Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change     significantly during a surveillance program.      Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly     during a surveillance program.      Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures of     GIST size.      Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.   "
87013|NCT02147132|"     Smoking prevalence is over 83% in methadone-maintained patients. These patients experience     significant difficulty quitting, and there is evidence that a majority of     methadone-maintained patients smoke most of their cigarettes in the 4 hours following     methadone dosing. The objective is to provide a preliminary test of the ability of two     pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos,     to reduce smoking during the 4 hours following methadone dosing.   "
87014|NCT02147119|"     The investigators will study Radial artery injury and endothelial function following     trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post-     angiography using Optical Coherence Tomography. The participants will also have radial     endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one week,     one month and three months post- angiography. Blood will be taken pre and 24 hours post     angiography for characterisation of endothelial progenitor cell numbers and function. The     hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated     dilatation which peaks at 24 hours and recovers at three months. The investigators hope to     correlate the rate of this recovery with peri-procedural progenitor cell numbers.   "
87048|NCT02146677|"     Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns.     Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs     (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso     2011). Moreover it was reported the absence of adverse events and side effects considering     the approach safe (Cerritelli 2013, 2014).      OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was     published addressing acute and chronic pain in different medical conditions. However, no     trials were carried out on pain in newborns. The aim of the present clinical trial is to     explore the effectiveness of OMT in reducing pain in a sample of preterm infants.   "
87049|NCT02146664|"     This is a prospective, randomized, double-blind, double-dummy, and controlled study of     DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without     early coronary revascularization. It is hypothesized that the combination of DLBS1033 with     aspirin and clopidogrel will result in greater reduction of infarct size in comparison with     that of aspirin and clopidogrel alone.   "
87324|NCT02143089|"     Use versus non use of urinary catheterization during Second Elective caesarean delivery:   "
87015|NCT02147106|"     Rationale: Patients with neuroendocrine tumors (NET) have a rare disease. Due to treating     patients with a neuroendocrine tumor in 'NET knowledge centers' patients often have to travel     long distances for follow-up visits at the outpatient clinic. Patients whose medical     condition allows videoconsultation could save time by replacing outpatient clinic visits     through videoconsultation for receiving follow-up care. Therefore, in this study we aim to     introduce videoconsultation as a alternative for follow-up outpatient clinic visits in NET     patients.      Objective: The primary objective is to assess if use of videoconsultation in follow-up care     for NET patients is feasible. We hypothesize that videoconsultation is a suitable medium for     providing follow-up care in NET patients. Secondary objectives are to explore the amount of     time videoconsultation takes in comparison with outpatient clinic visits and the     acceptability and satisfaction of physicians and patients with using videoconsultation in     follow-up care.      Study design: The present study is a single-centre prospective feasibility study.      Study population: Adult NET patients under surveillance or treatment of the department     Medical Oncology at the University Medical Centre Groningen (UMCG) whose medical condition     allows videoconsultation will be invited to participate.      Intervention: Patient who give informed consent will participate in the study. Participants     will receive follow-up care through videoconsultation instead of conventional visits at the     outpatient clinic.      Main study parameters/endpoints: The main endpoint is the feasibility of videoconsultation     for follow-up care in NET patients. We hypothesize that videoconsultation is a suitable     medium for providing follow-up care.   "
87016|NCT02147093|"     A comparative evaluation of a newly marketed multifocal contact lens with a single vision     contact lens when used with near vision spectacles. The evaluation was to quantify the     difference between the two test corrections.   "
87017|NCT02147080|"     Skin cancer is the most common cancer in the US, with over a million new cases diagnosed     yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing     skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all     age groups and also demonstrate increased exposure to natural and artificial UV radiation.     Innovative interventions are needed to have an impact on skin cancer risk among young people.     Unlike previous interventions, our skin cancer risk reduction intervention will be tailored     (or personalized) to each individual participant and delivered via the Internet. The     intervention will emphasize appearance concerns, which are known to be the primary motivation     for UV exposure and lack of skin protection among young adults. This will be accomplished in     part through the use of personalized facial images showing UV damage as well as computerized     age progression demonstrations.      Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet     designed to increase skin protection and decrease sun exposure behavior among young adults at     moderate to high risk of developing skin cancer. Participants will be randomized to the     tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.      Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family     history of skin cancer), appearance consciousness, and past exposure and protective behaviors     moderate intervention effects.      Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk     perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.      The goals of future research would be to enhance the tailored intervention, for example, by     adding additional contacts or Internet technologies or features, disseminate the     intervention, assess the longevity of effects, and/or adapt the tailored intervention for use     with other cancer risk behaviors or at risk groups.   "
87018|NCT02147067|"     The purpose of this study is to look at the effects of the drug Ranolazine compared to     Placebo on symptoms of chest pain or chest tightness (known as angina), exercise endurance     and ability, and changes in blood flow to the very small arteries of the heart (known as     coronary microvascular function) in patients who do not have significant blockages in their     major heart arteries. Ranolazine is a drug that is already approved by the FDA for angina,     but it may be particularly effective in people with disease in their tiny heart vessels     (known as coronary microvascular disease).      This trial aims to enroll 50 patients with angina who undergo baseline bicycle exercise     testing with monitoring of the heart's electrical activity and oxygen consumption (known as     cardiopulmonary exercise test) and coronary angiogram (taking pictures of the heart arteries     through small hollow tubes placed through the wrist or groin). If severe blockages in the     main arteries are not found then testing for coronary microvascular function will be     performed. Subsequently, participants will then be randomized 50/50 to either Ranolazine or     Placebo. After taking the study drug for 12 weeks, they will then repeat the cardiopulmonary     exercise test and the coronary angiogram with testing for microvascular function.   "
87042|NCT02146755|"     Aortic stenosis is a common valvular heart disease, affecting mainly people over age 60. It     is characterized by years to decades of slow progression followed by rapid clinical     deterioration and a high death rate once symptoms develop. The onset of symptoms confers a     poor prognosis: patients die within an average of five years after the onset of angina, three     years after the onset of syncope, and two years after the onset of heart failure symptoms.     The overall mortality rate is 75% at three years without surgery. Drug therapy for it remains     ineffective, and aortic valve replacement is the only recommended long-term treatment.   "
87019|NCT02147054|"     Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many     patients who ingest organophosphates require ventilation; of these patients approximately 50%     die. Much of the mortality in these ventilated patients is secondary to intermediate     syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of     acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess     acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest     or prolonged ventilation and its associated complications.      The investigators believe that blocking these receptors using a neuromuscular blocking agent     such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome     and reduce number of intubated days and mortality.      In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor     antagonist, will be used to bind to the receptor at the neuromuscular junction and to block     the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase     in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is     eliminated from the body.   "
87020|NCT02147041|"     The aim of this study is to examine the therapeutic effect of green tea extract on obese     women and the correlation analysis between traditional Chinese medicine syndrome and obese     related hormone peptides.   "
87021|NCT02147028|"     The purpose of this study is to evaluate whether sparing the hippocampi during whole brain     radiotherapy following neurosurgery or stereotactic radiosurgery in patients with brain     metastases from a systemic tumour helps preserve brain function.   "
87022|NCT02147015|"     The hypothesis is that in acute exacerbated Chronic Obstructive Pulmonary Disease (AECOPD),     personalized variable dose glucocorticoid treatment will result in superior clinical outcome     when compared to fixed or experiential dose therapy.   "
87023|NCT02147002|"     The National Register of Nephrology in 2007 shows, similarly to the European data, a problem     of a high mortality rate among Polish dialysis patients.      The main reason of death among chronically dialysis patients are cardio - vascular system     diseases. According to The Report on the Condition of Renal Replacement Therapy in Poland in     2007, these diseases are the cause of 53% deaths in Poland. The patients with chronic kidney     disease (PChN) are particularly at risk of cardio - vascular complications. These     complications occur on average 30 times more often than in the whole population, and among     young dialysis people, these complications occur 300 times more often. In the development of     cardio - vascular complications polyunsaturated Omega-3 acids (especially eicosapentaenoic     acid - EPA and docosahexaenoic acid - DHA) take a special position. The reaction of     polyunsaturated Omega-3 acids on the cardiovascular system results from the enrichment of     phospholipids of cell membranes within EPA and DHA. It should be noted that their impact is     dependent on the type of acid and on the dose. Docosahexaenoic acid reacts with lipids and     lipoproteins, blood pressure, heart rate, amount of glucose, and eicosapentaenoic acid is     responsible for antiplatelet effect.      This project is aiming at defining and elaborating on the connection between Omega-3 acids,     and cardiovascular complications, their influence on the functioning of the cardiovascular     system, and moreover, a better understanding of the effects of therapeutic and     pharmacological therapies in patients at different stages of chronic kidney disease. Carrying     out this project will be a good start to shape an international project in this area.   "
87024|NCT02146989|"     Rationale:      Children with Cerebral Palsy (CP) experience limitations in motor activities and     participation in the community, predominantly caused by impairments in muscle function. Aside     from abnormal posturing due to spasticity, muscle weakness can significantly contribute to     impaired muscle function and there is increasing evidence that muscle weakness significantly     impairs upper limb motor function and ability to perform manual tasks in children with CP.     Studies in the last decade have shown that muscle weakness, not spasticity, is the greatest     limiting factor of motor function in children with CP. Furthermore, there is increasing     evidence that the strength in the upper extremities of children with CP is less compared to     their typically developing peers (TDP). A systematic review focused on the psychometric     properties of strength measurement instruments has shown that the number of studies     investigating psychometric properties of strength measurement instruments is limited and that     the methodological quality of these studies is low.      Aim:      The present study aims to investigate the reproducibility of the following three isometric     strength measurements in the upper extremity of children and adolescents with unilateral CP     as well as in TDP: Hand Held Dynamometry (HHD), pinch and grip strength using the E-link     system and functional strength. To study to which extent upper extremity strength, both in     the affected side and the non-affected side, differs from the strength in the upper     extremities of TDP, these measurements will also be performed by children without     neurological problems.      Study Design:      A cross-sectional study in which the reproducibility of three strength measurement     instruments, i.e. HHD, E-link and Functional strength, will be investigated in children and     adolescents with unilateral CP and TDP.      Population:      Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents),     aged 7 to 18 years, Manual Ability Classification System (MACS) levels I-III, who are     mentally able to perform the measurements will be included and TDP.      Outcome measures:      The most important psychometric property in strength measurement instruments is     reproducibility. Reproducibility will be investigated using the following factors: Intraclass     Correlation Coefficient (ICC), Limits of Agreement (LOA), Standard Error of Measurement (SEM)     and the Smallest Detectable Difference (SDD). Reference values will be determined using the     Generalised Additive Models for Location, Scale, and Shape (GAMLSS) method.   "
87025|NCT02146976|"     The investigators designed a study to determine whether Propofol or Sevoflurane would provide     same postoperative sleep quality in patients undergoing thyroidectomy.   "
87026|NCT02146963|"     This study is complementary to the main study Brain Derived Neurotrophic Factor Serum Levels     Evolution During the Six Months After Alcohol Withdrawal  NCT01491347.      The purpose of this study is to evaluate the Bdnf gene - Val66Met polymorphism in subjects     with alcohol dependence according to their alcohol consumption status 6 months after     withdrawal (relapse or abstinence), in relation to the presence of psychiatric     co-morbidities.   "
87027|NCT02146950|"     This study is designed to investigate whether LCS12 is associated with an increased risk of     unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among     new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy,     uterine perforation, and PID) associated with the use of LCS12 compared with the established     hormonal IUD Mirena, and compared with established copper IUDs during standard clinical     practice. In addition, drug utilization patterns will be described.   "
87028|NCT02146937|"     This is an open label, single site, single arm Phase II study to evaluate the combination of     bicalutamide plus finasteride in men with MRI detectable significant prostate nodules     followed on active surveillance.   "
87029|NCT02146924|"     This phase I trial studies the side effects and best dose of cellular immunotherapy in     treating patients with high-risk acute lymphoblastic leukemia. Placing a modified gene into     white blood cells may help the body build an immune response to kill cancer cells.   "
87043|NCT02146742|"     Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to     assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and     distributed through the body.   "
87030|NCT02146911|"     Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline     are available to help smokers quit but there are not widely used. The primary objective of     this study is to evaluate the real-world long-term effectiveness of of bupropion and     varenicline treatment in a community sample of smokers interested in quitting. The     investigators hypothesize that varenicline treatment will result in higher quit rates at end     of treatment and at one year after treatment compared to bupropion. Smoking status will be     biochemically confirmed at various time points using salivary cotinine measures. Furthermore,     since 50% of the variation in quit success is genetically determined, and the effectiveness     of different cessation medication may differ considerably in sub-groups of smokers carrying     certain genetic variants, the investigators will collect saliva samples from consenting     participants to evaluate the moderating effect of genetics on treatment response.   "
87031|NCT02146898|"     The investigators intend to study the impact of patient positioning on the changes in blood     pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that     the changes in blood pressure relate to the speed with which the spinal medication rises. By     slowing the rise of spinal anesthesia, the investigators believe that the incidence and     severity of hypotension might be reduced.   "
87032|NCT02146885|"     The first step in any clinical intervention against obesity involves sustained lifestyle     changes. Researcher can use these strategies to beneficial the effects of weight and on     cardiovascular risk. The researcher develope methods for assessing the effectiveness use     optical technology to make such assessments, specifically in the area of fatty tissue can     predict the effectiveness of the intervention in causing weight reduction and treating     metabolic disease.   "
87033|NCT02146872|"     Since finishing the sequencing of the human genome in 2003, genetic research in coronary     artery disease (CAD) and other complex traits have developed dramatically. Recent genome-wide     association studies have identified a considerable number of common genetic variants each     associated with the disease. This has led to a new understanding but also to the discovery of     new therapeutical targets. However, each of the variants discovered only have minor effects     on disease development and even the pooling of the variants only explains a minor percentage     of the total heritability. It has been evident that rare or private mutations probably play a     great role in the genetic architecture of CAD, especially among young and severely affected     patients. These may only be identified by sequencing. Therefore, the investigators     hypothesize, that the use of exome sequencing (the read-off of the entire protein-coding     regions of the genome) and linkage analysis in families of extreme phenotype cases, will     identify disease-causing genetic variants. From the West Denmark Heart Registry the     investigators will enroll a minimum of 120 patients with atherosclerosis who have undergone a     coronary artery revascularization procedure before the age of 40, to participate in study     part 1. A pedigree analysis will be performed and cardiovascular (CVD) risk factors and     current preventive treatment will be evaluated. 1. degree relatives aged 30-65 years, who are     free of CAD, are invited to participate in study 2. CVD risk factors are evaluated as well as     a CT coronary angiogram is performed to quantify the degree of asymptomatic coronary     atherosclerosis. Families from study 1 and 2, who are considered severely affected by     atherosclerosis, evaluated on a basis of family size, number of affected and severity of     disease, will be selected for exome sequencing. Other relevant family members will be     included as well as their CVD risk factors will be evaluated. Exome sequencing will be     performed and variants found will be filtered on a basis of frequency, linkage analysis, gene     position, existing knowledge and in-silico prediction tools. Possible findings will be     validated by Sanger-sequencing and causality of new variants will subsequently be sought to     be proven by relevant experimental studies.   "
87034|NCT02146859|"     Background When general anesthesia was performed, neuromuscular blocking agents (NMBAs) are     frequently used for facilitate tracheal intubation and keep patient still and relax during     surgery. Unfortunately, residual neuromuscular blockade are important complication.      There are many factors that affect neuromuscular blockade and may prolong effect of NMBAs     which we already know about that such as body temperature, drugs, some kind of diseases.     However there are no recent studies that mention about other factors. The purpose of this     study is to find out other factors that affect NMBAs effect to improve patient safety.      Methods The study is a prospective, non-randomized, blinded, observational study.      222 patients will be included in this study and will be performed general anesthesia.     Anesthetic technique and agent which are used depend on regular staff. Information of patient     will be collected are age, sex, weight, height, ASA classification, anesthetic technique,     anesthetic and surgical time, amount of inhalation agent, amount of NMBAs, amount of opioids     and reversal agents.      After anesthesia finish, patient will be brought to recovery room and Train Of Four watch®     will be placed and record Train Of Four ratio by this research staff. Train Of Four ratio <     0.9 will be defined as there is residual neuromuscular blockade in this patient.      All patients will be divided into 2 groups: residual blockade group(patient who have train of     four <0.9 after surgery) and no residual blockade group(patient who have train of four >0.9).     All factor of each group will be compared between. Statistical will be analyzed to find     significant factor which affect neuromuscular blockade.   "
87035|NCT02146846|"     The purpose of this study is to determine population Pharmacokinetics and differences and     variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in     treatment of chronic myeloid leukemia patients in Iranian population.   "
87036|NCT02146833|"     This is an open-label, Phase 2 clinical study of the oral Selective Inhibitor of Nuclear     Export (SINE) Selinexor (KPT-330) in patients with metastatic castration-resistant prostate     cancer (mCRPC).   "
87037|NCT02146820|"     The purpose of this study is to determine whether Pico laser is effective and safe in the     treatment of benign pigmented lesions.   "
87038|NCT02146807|"     The purpose of this study is to determine whether Pico laser is effective and safe in the     treatment of unwanted tattoos.   "
87039|NCT02146794|"     Renal denervation can be carried out for heart failure   "
87040|NCT02146781|"     This is a research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is     called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is     tolerated and how research participants respond to the vaccine using a different route of     administration, the Intradermal (ID) route. CryJ2-DNA-LAMP Plasmid vaccine is     investigational, which means it is not approved for use by the United States Food and Drug     Administration (FDA) but is available in research studies like this one.      The study is a Phase IC study to assess and evaluate the safety and immunological responses     to therapeutic doses of a dosing regimen of 1.08 mg and 2.16 mg of CryJ2-DNA-LAMP plasmid     vaccine delivered intradermally (ID) using the Biojector 2000 device, to be administered     every 14 days in subjects with atopic sensitivity to Japanese Red Cedar pollen, identified by     skin test reactivity to this pollen. The protocol has three subject cohorts: a Cohort 1:     composed of atopic and non-atopic subjects (half atopic and half non-atopic), who will only     receive saline control administered using the Biojector 2000 device; a Cohort 2: atopic     subjects, who will receive 2.16 mg per dose in a four (4) dose regimen using a Biojector 2000     device; and a Cohort 3: atopic subjects, who will receive 1.08 mg per dose in a four (4) dose     regimen vaccinated using a Biojector 2000 device.The study will be conducted at 1 study     center. Subjects are enrolled in the trial for a period of 132 days. The objectives of the     statistical analyses are to establish the safety and to explore the immunogenicity of the     LAMP-vax vaccine using a different route of administration, the Intradermal (ID) route. All     statistical analyses conducted on the data from this trial will be exploratory in nature.      The primary objective of this Phase IC Study is to evaluate the safety and immunological     responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine     delivered intradermally (ID) using the Biojector 2000 device.   "
87044|NCT02146729|"     In patients presenting with Type A and Type B1, B2 thoracolumbar fractures, there is a lack     of evidence demonstrating similar outcomes between patients treated with percutaneous pedicle     screws and those treated openly. It has been demonstrated that percutaneous pedicle screw     fixation has fared well for patients in the short term; however, it is unclear whether the     outcomes are equivalent or inferior/superior compared to open treatment.      The authors seek to establish a high-level evidence base to determine clinical patient     outcomes, radiographic outcomes, as well as cost-effectiveness data in comparing     thoracolumbar burst fracture patients treated with percutaneous pedicle screws, open     treatment, and brace treatment. Additionally, the authors seek to establish data relating to     patient occupational data, complications, and need for further surgery (revision/removal of     hardware), as well as short-term variables relating to hospital visit (length of stay,     estimated blood loss, time under fluoroscopy).   "
87045|NCT02146716|"     The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous     Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to     measure the benzodiazepine amount prescribed during the withdrawal time.   "
87046|NCT02146703|"     This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy in     patient with advanced biliary tract cancer   "
87047|NCT02146690|"     The aim of the present 3 armed placebo control parallel group randomized control trial is to     explore the extent to which osteopathic manipulative treatment is effective in reducing pain     in a population of complicated newborns.   "
87944|NCT02134951|"     The purpose of this study is to assess the relative feasibility of 2 potential functional     measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in drug     development for psychotic spectrum disorders.   "
87050|NCT02146651|"     The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the     duration of action of insulin lispro due to facilitation of the absorption of the insulin     after subcutaneous injection.      The aim of the trial is to investigate the dose-response and the dose-exposure relationships     of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and     glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and     to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.      This is a double-blinded, randomised, four-period crossover phase 2 trial using automated     12-hour euglycemic clamps in subject with type 1 diabetes mellitus.      Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three     single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of     Humalog® (0.2 U/Kg) on 4 separate dosing visits.   "
87051|NCT02146638|"     Aim of this study is to compare benefits and disadvantages in using continuous infusion of     morphine or fentanyl for post operative analgesia.   "
87052|NCT02146625|"     The objectives of this study are:        -  To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy          male volunteers.        -  To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.        -  To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.        -  To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.   "
87053|NCT02146612|"     The present study aims to evaluate the patient profile including medical conditions who use a     nutritional supplement along with a balanced and varied diet in Turkey.   "
87054|NCT02146599|"     The purpose of this study is to evaluate the visual quality and function of pseudophakic     patients.   "
87055|NCT02146586|"     This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed     to be implemented across all sites participating in the Cooperative International     Neuromuscular Research Group (CINRG) research studies. The study will determine if the     selected techniques are reliable and reproducible across the CINRG network by evaluating the     reliability and reproducibility of the measures between CEs   "
87056|NCT02146573|"     This study will implement and evaluate the effects of a pediatric continuity care intensivist     program. This study will determine the impact of an additional pediatric intensive care unit     (PICU) intensivist on outcomes at the patient and family level. It will also evaluate the     training program to prepare the continuity care intensivist (CCI).   "
87057|NCT02146560|"     Background to main study question: Cardiac complications are a common cause of morbidity     after non-cardiac surgery. Patients with perioperative myocardial injury (both MI, and lower     levels of cardiac troponin elevation) experience higher short-term and long-term mortality.     They are also at substantially increased risk of additional cardiac and non-cardiac     complications. It is therefore plausible that myocardial injury adversely affects quality of     life. This study will compare postoperative health-related quality of life of patients who     did or did not experience perioperative myocardial injury (defined by troponin-I > 0.07ng/ml)     after non-cardiac surgery      Study Design: Pilot prospective cohort study (n = 300). Population: Consecutive patients     undergoing non-cardiac, non-transplant surgery at UHN.      Background to secondary study questions:        1. Clinically based risk stratification tools used in non-cardiac surgery (e.g., Revised          Cardiac Risk Index) are of moderate utility and assign patients only to broad risk          categories. This study will examine the usefulness of pre-operative biomarkers (BNP,          HbA1c, and others) in supporting cardiac risk stratification and will address the          question: Is there a set of preoperative criteria that can accurately inform the          decision to monitor troponin postoperatively?        2. Intra-operative physiological derangement measured with the Surgical Apgar Score          correlates with morbidity and mortality 3-months postoperatively. This study will          examine the relationship between the Surgical Apgar Score; continuous non-invasively          monitored intraoperative metrics of hemoglobin concentration and occult hypovolemia          (Pleth Variability Index) with the Masimo Radical-7 Pulse Co-Oximeter; and the primary          and secondary outcomes. This aspect of the study will address the question: Can readily          available intraoperative physiological data inform the decision to monitor troponin          postoperatively?        3. Quality of Recovery-40 Score evaluates (in the recovery room and at 24 hours          postoperatively) the patient's subjective experience of their recovery from surgery.          This metric is correlated with quality of life 3-months postop. This study will evaluate          correlation between Quality of Recovery-15 Score, a valid and more efficient means of          measuring recovery, and the primary and secondary outcomes.        4. Approximately 2/3 of patients who have postoperative myocardial injury are asymptomatic          and have no ECG changes. Diagnosis of MI requires biomarker elevation (Troponin >          0.3ng/ml) plus clinical or ECG or imaging evidence of myocardial injury. Of the latter 3          criteria, 2 are often absent. In selected patients, this study will use trans-thoracic          echocardiography, CT coronary angiography, and cardiac MRI to improve diagnostic yield          and define those diagnostic modalities that are most useful in the postoperative          patient.      Rationale:      Postoperative myocardial injury may negatively impact health-related quality of life.     Affected patients may experience higher levels of postoperative dependency. This possibility     has implications for patient rehabilitation, provincial and personal healthcare costs, as     well as patients' physical, emotional and mental well-being and relationships. The public     health dimension of this problem could therefore be significant. In addition, an incomplete     understanding exists of how individual patient cardiac risk factors, in combination with the     perioperative environment, result in myocardial injury. The diagnostic investigations that     are most useful in this setting have not yet been clearly defined. Patients who fail to be     rescued after experiencing postoperative complications (as distinct from failure to avoid     experiencing the complication in the first instance) plays a central role in postoperative     mortality. Early recognition of such patients is therefore crucial. By prospectively     observing a cohort of high-risk surgical patients, this study will provide insight into how     these factors interact. This will allow us to better characterize the potential predictors     and features of postoperative myocardial injury. We hope that our findings will aid in the     identification of patient characteristics associated with increased risks of postoperative     myocardial injury, thus helping to direct diagnosis, early treatment and rescue. This study     will thus potentially yield important data that will positively impact future patient care     and the rational use of healthcare resources.   "
87058|NCT02146547|"     Schizophrenia is a chronic psychiatric illness with periods of remission and relapse.     Patients vary in the frequency and severity of relapse, time until relapse and time in     remission. Discontinuation of antipsychotic medication is by far the most important reason     for relapse. A possible method to optimize medication adherence is to treat patients with     long-term, depot medication rather than oral medication. However, despite its apparent     common sense this approach has neither been universally accepted by practicing     psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we     aim to investigate possible advantages of depot medication over oral antipsychotics in an     independently designed and conducted, randomized, pragmatic trial.   "
87082|NCT02146235|"     The investigators combine traditional medical care with an integrative modality - Music     Therapy specifically including wind playing, singing, and music visualizations- to study the     effects on physical function and quality of life for adults with COPD. The primary goals are     to increase respiratory function and reduce respiratory symptoms and hospitalizations in     order to improve breathing, functional capacity for activities of daily living, psychological     well-being and quality of life in adult age 45 and above who are diagnosed with COPD   "
87059|NCT02146534|"     Phase 4, single center, double-blind, placebo-controlled study. Fifty (50) patients with     MacDonald criteria (2005) multiple sclerosis will undergo active motor training as per the     NeuroGym protocol, consisting of 3 sessions of 1 hour per week for a period of 6 weeks (total     of 18 sessions).      Half of the patients will be randomized to receive prolonged-release fampridine 10 mg BID as     per label, and the other half will receive a placebo BID.      All patients will continue to take their medication (fampridine or placebo) during a     subsequent observational period of 8 weeks. Patients will be evaluated at times -4, 0, 6 and     14 weeks.      Study Objectives:      Primary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID     will show greater benefit from active motor training as compared with subjects treated with     placebo in terms of incidence of responders, degree of response, and duration of response.      Secondary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID     will show greater benefit from active motor training as compared with subjects treated with     placebo in terms of quality of life measures.   "
87060|NCT02146521|"     The purpose of the study is to compare the diagnosis and management (treatment and     disposition) of adult emergency department patients with acute nontraumatic abdominal pain     and tenderness, based on two CT techniques:        1. Standard (complete) abdominal-pelvic CT. The American College of Radiology calls for the          cephalad limit of abdominal CT to begin at the dome of the diaphragm, and the caudad          limit of pelvic CT to extend through the ischial tuberosities.        2. A z-axis restricted subset of images digitally obtained from the original CT dataset,          determined by the region of tenderness identified by the examining emergency physician          and marked on the patient prior to the performance of the CT. This z-axis restricted CT          does not require any additional radiation exposure to the patient, as it will be          produced by computer extraction of data from the original standard abdominal-pelvic CT.      The investigators hypothesize that the diagnosis and management will not differ when guided     by the two CT scan interpretations. Radiation doses will be calculated for each of the two     techniques.   "
87061|NCT02146508|"     Esophageal cancer is common in Kenya. The precursor of esophageal cancer is esophageal     squamous dysplasia (ESD). In this study, persons known to have ESD will undergo endoscopic     removal or ablation of ESD in order to prevent development of esophageal cancer.   "
87332|NCT02142985|"     Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult     in some situations and need to be confirmed with other investigations such as semi invasive     cardiac output measurement based on the Flo-Trac receptor and the Vigileo monitor.      Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness     to fluid filling maneuver in patients with hemodynamic instability.   "
87062|NCT02146495|"     Fibromyalgia is a clinical syndrome characterized by extensive chronic pain. Today, the main     theory argues the origin of the pain is central sensitization which is en amplification of     processing and transferring neuronal signals. Patients usually suffers a wide range of     symptoms: extensive pain, chronic fatigue disorders of sleep (having trouble falling asleep,     fragmented sleep and early awakening) , mood disorders and cognitive damage. To treat the     sleep disorder, the pain and the depuration with Fibromyalgia patients is a complex clinical     challenge that usually requires combination of different medicines (short term analgesic +     long term analgesics + anti-depressives and so on). Patients are also referred to other     treatments such as cognitive behavioral therapy (CBT), occupational therapy treatment,     phycisal therapy, alternative medicine and so on.      Another such non-medical treatment is to try and modifies the patterns of activity of the     patient's brain. One approach that draws attention in the last few years is EEG based     neuro-feedback (NF). EEG NF is a closed circuit brain computer Interface (BCI) in which the     patient gets a feedback from his or her own brain that signifies a certain mental state. The     brain-patient feedback allows to train patients in performing a voluntary change of a     dedicated brain area, such as pain related areas. In this study we intend to assess the     effect of two different EEG-NF protocols targeting different brain areas as compared to     placebo (sham) NF and drug therapy on pain and sleep quality measures in fibromyalgia     patients.   "
87063|NCT02146482|"     The purpose of the study is to evaluate the changes in back pain from access to a sit-stand     workstation. Other muscle and joint pain and/or discomfort will also be evaluated. We     hypothesize that access to a sit-stand workstation will allow one to experience postural     variation and reduce back pain.   "
87064|NCT02146469|"     The objective of the study is as follows:        1. To know the antibody level during different interval after received 1 dose varicella          vaccine.        2. To know safety and effectiveness of received 2 doses varicella vaccine with different          interval.        3. To know safety and effectiveness of received varicella vaccine and MMR at the same time.      To achieve that, this study selects children with specific varicella vaccine history, gives 1     or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after     vaccination.      All blood specimens will be tested by a third-party detection institution.   "
87065|NCT02146456|"     Colloid solution is generally used to maintain intravascular volume. It is reported to impair     blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation     time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis     in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis     primarily by diminishing α2-antiplasmin-plasmin interaction.      Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of     plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule     responsible for the degradation of fibrin, a protein that forms the framework of blood clot.     It is used to treat or prevent excessive blood loss during surgery and in other medical     conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction,     or potential risk of thrombosis is reported as the adverse effect of tranexamic acid.      We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration     can improve the colloid-induced clot strength impairment.   "
87083|NCT02146222|"     This partially randomized phase I trial studies the side effects and how well sequential     dosing of vascular endothelial growth factor receptor (VEGFR)/platelet derived growth factor     receptor (PDGFR) dual kinase inhibitor X-82 and docetaxel works in treating patients with     solid tumors. VEGFR/PDGFR dual kinase inhibitor X-82 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving VEGFR/PDGFR     dual kinase inhibitor X-82 and docetaxel one at a time instead of concurrently may work in     treating patients with solid tumors.   "
87066|NCT02146443|"     The purpose of this study is to measure test-retest reliability and validate the star shaped     test of manual dexterity. The purpose of this is to see if there is any significant learning     effect, and if the test can discriminate between individuals who are at their normal skill     level, and when they are stressed and/or fatigued. The test is designed to test hand to eye     coordination and precision control. This is done by following a star shaped track with a pair     of a surgical scissors. this is done 10 times, 5 times clockwise and 5 times counter     clockwise. Each time the scissors come into contact with the border of the track, an error is     counted. Overall completion time is recorded. As a randomized crossover study, we will have     20 test subjects complete the test 4 times. Each test will be conducted with a pause of two     breaks between the tests. Before each test, the test subjects are randomized to: no     intervention, physical fatigue prior to testing, distractions during the test or both     physical fatigue prior to testing and distractions during the test. All participants will     complete a test with all four interventions. Furthermore, a test-retest trial will be     conducted on 4 test-subjects. Each subject will complete the test two times with no     interventions, with two days apart.   "
87067|NCT02146430|"     The main objective of this trial is to compare change in weekly average daily pain score     (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo.     Weekly ADPS is based on daily pain scores reported by the subject that best describes his or     her worst pain over the previous 24 hours.   "
87093|NCT02146092|"     After any surgery, there is a chance of complications. After lung surgery to remove tumours,     there is a particularly high chance of a person developing an infection or needing help     breathing, called post operative pulmonary complications. Currently, the risk of these     complications is reduced through the completion of light physical and deep breathing     exercises and walking around as soon as possible after surgery. Another possible way of     helping these patients is to use a small device called an Incentive Spirometer to encourage     and measure deep breathing. This study wants to compare how often postoperative pulmonary     complications happen after major lung surgery between a group completing the exercises alone     and a group using the Incentive spirometer in addition to the exercises. It is hoped that the     combined therapy will reduce the amount of time patient must stay in hospital, have fewer     complication events and have fewer patients re-admitted back into the hospital after they go     home, so that patients overall have better outcomes.   "
87068|NCT02146417|"     As both patients with end-stage kidney disease and society benefit tremendously from live     kidney donation, the safety and well-being of kidney donors are highly important objectives     in live kidney donation. Laparoscopic donor nephrectomy has several advantages over open     nephrectomy, such as less post-operative pain, better quality of life and shorter hospital     stay. Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice in most     countries.      So far, modifications of the technique of laparoscopic donor nephrectomy, i.e. hand-assisted     and/or retroperitoneoscopic approaches, did not show a significant benefit with regard to     safety as reflected by the conversion to open and postoperative complications rate. We     therefore believe that further research should focus on the optimization of early     postoperative pain and its concomitant use of opioids. Since non-steroidal anti-inflammatory     drugs are contra-indicated before and after nephrectomy, the management of postoperative pain     largely depends on the administration of opioids. Measures to reduce postoperative pain would     also reduce the occurrence of postoperative nausea and vomitus, and postoperative bowel     dysfunction.      A recent pilot study performed by our group showed that the use of low pressure     pneumoperitoneum was feasible and significantly reduced deep intra-abdominal and referred     pain score during the first 72 hours after surgery. Previous studies performed by others show     that low pressure pneumoperitoneum is associated with reduction of systemic inflammatory     response, post-operative pain and analgesic consumption. Martini et al have shown that deep     neuromuscular block improves surgical conditions during laparoscopic surgery with standard     intra-abdominal pressure. To facilitate the use of low pressure pneumoperitoneum, deep     neuromuscular block improves surgical conditions and might become a prerequisite for the use     of low pressure pneumoperitoneum.      Our hypothesis is that the combination of low pressure pneumoperitoneum and deep     neuromuscular block improves quality of recovery in the early post-operative phase.   "
87069|NCT02146404|"     Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people     with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation,     characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia unawareness,     which in itself defines a particularly high risk of severe hypoglycemia. Recent evidence     suggest a pivotal role for increased brain lactate transport capacity in the pathogenesis of     hypoglycemia unawareness. However, there is uncertainty about the magnitude of this effect     and whether such excess brain lactate is oxidizes as a glucose-sparing alternative energy     source or acts as a metabolic regulator controlling brain glucose metabolism, oxygen     consumption and cerebral blood flow.      Objective: The primary objective of this study is to investigate the effect of hypoglycemia     on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary     objective is to assess whether this effect is a related to hypoglycemia unawareness or a     consequence of T1DM per se.      Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport over     the blood-brain barrier leading to cerebral lactate accumulation and that this lactate     accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical     hypoglycemia unawareness. Furthermore, the investigators expect that this effect of     hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow     (CBF).   "
87070|NCT02146391|"     This study is an open-label, randomized, single-center, single-dose, two-way crossover study     of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each     receive a single dose of Androxal 25 mg in both the fed and fasting state.   "
87071|NCT02146378|"     The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions     [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to     as Vyndaqel) in all patients who received this drug under actual use conditions after its     marketing.   "
87072|NCT02146365|"     One possible mechanism of protection from pneumococcal disease with a killed whole cell     vaccine is by altering the carriage of pneumococcus germs in the nose and throat of those who     get the vaccine. This study will look at nasal swabs from toddlers who received a killed     whole cell pneumococcal vaccine (PATH-wSP) in VAC-010 and compare them to nasal swabs from     toddlers of the same age who did not receive the PATH-wSP vaccine. This information will be     used to help further develop the PATH-wSP vaccine. The research will be done in Kenya at one     site in Kisumu (KEMRI). The study will enroll healthy Kenyan toddlers (12-15 months of age)     who are participating in the VAC-010 study (N=250) and whose parents provide consent for this     study. In addition 50 healthy Kenyan toddlers of similar age who did not participate in the     VAC-010 study will also be enrolled.      The toddlers will be followed for 6 months and will have 5 study visits. During those study     visits each toddler will have their nose and back of their throat swabbed. The material from     the swab will be analyzed for the presence and type of pneumococcal and other germs. At the     last visit, one blood sample (5 ml or approximately 1 tsp) will be obtained.      There will be no direct benefit to the participants other than direct and immediate medical     care as needed.      Parents of all participants will provide written informed consent.   "
87073|NCT02146352|"     The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent     with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of     pancreatic pseudocysts.   "
87084|NCT02146209|"     The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400     mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl     125 mg/5 ml (125 mg Metronidazole Per 5 ml Suspension) and to Zentiva Flagyl™ 400 mg Tablets     (400 mg Metronidazole Per Film Coated Tablets).   "
87085|NCT02146196|"     Robotic assisted gait therapy with the Lokomat® as a new method for rehabilitation in     advanced heart failure and after cardiac surgery.   "
87074|NCT02146339|"     Polar lipids have a specific chemical structure: they are an essential component of human     cell membranes, play a major role in the nervous system and also influence the metabolic     pathways including the cholesterol metabolism.      Polar lipids are used in food-processing industry for their emulsification properties. The     most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers     such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have     beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional     origin.      The purpose of this research is to study the variation of sphingomyelin content at the     ileum's end after the consumption of different doses of milk polar lipids, and consequences     on the intestinal absorption and metabolism of fatty acids and cholesterol.      The subjects will be taking three different test meals varying by their milk polar lipids     content.      It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine     Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).   "
87094|NCT02146079|"     This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics     (the exposure of the trial drug in the body), pharmacodynamics (the effect of the     investigated drug on the body), and the safety and tolerability of semaglutide in healthy     male Japanese and Caucasian subjects.   "
87075|NCT02146326|"     Healthcare providers play an important role in helping patients be actively involved in     treatment and recover from mental illness. But mental health clinicians, like other     healthcare providers, are at risk for experiencing burnout—feeling emotionally drained from     their work, having cynical thoughts toward patients and others, and feeling little     accomplishment in their work. Burnout can lead to problems for the clinician including poor     overall health, depression, and lower job satisfaction. Burnout also can impact how     clinicians perform on the job; for example, people with high levels of burnout take more time     off, show lower commitment to their job, and are more likely to quit or be fired. There is     some evidence that burnout can affect the quality of care for patients, but very little     rigorous research has tested this assumption. The purpose of our study is threefold. First,     we will investigate how patients perceive burnout in clinicians and whether (and/or how)     burnout impacts the care they receive. Next, we will test an intervention to reduce clinician     burnout called Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education     (BREATHE). BREATHE brings together tools that mental health clinicians are already familiar     with, including relaxation and mindfulness exercises, setting boundaries, using social     supports, and changing negative thought patterns and replacing them with more helpful ways of     thinking. We have found this intervention effective in reducing burnout in other     organizations, but have yet to study whether it also can improve patient outcomes. Clinicians     (approximately 200) who participate will receive either the BREATHE intervention or training     in motivational interviewing, which could also improve patient involvement in treatment and     patient outcomes, but is unlikely to significantly reduce clinician burnout. We will also     recruit up to 600 adult patients served by participating clinicians. We will survey     clinicians and interview patients over a 12-month period after the intervention to determine     how the intervention impacts clinician burnout and patient perceptions of care (relationship     with the clinician, degree of autonomy in decision making), patient involvement in care, and     outcomes (confidence in managing mental health, symptoms, functioning, and hope). Finally,     this study will use a statistical procedure called Structural Equation Modeling to test a     theoretical model of the relationship between burnout and patient outcomes. Findings from     this study will show whether reducing clinician burnout can improve patient outcomes and the     quality of care that patients receive. Our intervention will have the potential to be easily     implemented in a variety of settings where burnout is a problem. Knowing how clinician     burnout impacts patient outcomes, and whether improving burnout can improve patient care, can     help improve the healthcare system.   "
87076|NCT02146313|"     This is a Phase I, multicenter, open-label, dose-escalation study of DMUC4064A administered     by intravenous (IV) infusion every three weeks (q3w) to cancer participants. The study will     employ a traditional 3 + 3 dose escalation design to determine the maximum tolerated dose     (MTD) of DMUC4064A against platinum-resistant ovarian cancer. Once a q3w recommended phase II     dose (RP2D) is identified, two expansion cohorts (one in platinum-resistant ovarian cancer     and another in unresectable pancreatic cancer) may be evaluated to further characterize the     safety and activity in these populations.   "
87077|NCT02146300|"     The purpose of this study is to find out how the provocation of the nose changes breathing     style (specifically, frequency and tidal volume changes)   "
87078|NCT02146287|"     Preterm babies cared for in the intensive care nursery are exposed to amounts of light that     are very different from the exposures to an unborn baby or the newborn term baby. Currently     many nurseries try to protect premature babies from too much light. They may also try to     create light conditions of day and night like many parent homes. Some studies have shown     improvements in health and development of babies cared for in nurseries that try to change     light for premature babies.   "
87079|NCT02146274|"     PROSPER (Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness     Research) is a three year research project to create a national, sustainable model to improve     decision-making and patient-centered stroke outcomes through comparative effectiveness     research.   "
87080|NCT02146261|"     This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind,     placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and     tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be     randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort,     six subjects will receive the single subcutaneous E6011 administration and two subjects will     receive the single subcutaneous placebo administration.   "
87081|NCT02146248|"     The investigators' research group is working to develop a highly effective, low cost     non-surgical method of permanent contraception for women. To support this goal, we need to     know more about the normal fallopian tube (tube that passes the egg from the ovary into the     womb). The purpose of this study is to learn about how menstrual cycles and hormonal     contraceptives affect tubal patency. Normally there is an opening between the tube and uterus     to permit the flow of fluid and cells. If this opening is blocked, this can result in     infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency     is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy     (HSG). HSG is a standard radiological imaging study that is used to determine if the     fallopian tubes are open and free of disease. It is commonly done in women with an     infertility diagnosis. The investigators usually do this test in the first 10 days of the     menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are     actually open. The timing of the HSG study during the menstrual cycle, or the use of hormonal     contraception may make a difference in whether the tubes appear blocked on the HSG when they     are actually patent.      The results of the HSG test provide a good model for how our nonsurgical permanent     contraception method might work. The investigators think that if the tubes are not patent,     that our treatment will not work as well. Therefore, in this study we want to learn if     menstrual cycle timing or current hormonal contraception use will affect the patency of the     tubes as assessed by the HSG. The investigators want to examine the same women to see if     tubal patency is changes during the menstrual cycle and during the use of a birth control     pill and the birth control shot.   "
87086|NCT02146183|"     The aim of this experiment is to investigate if intake of stevioside in addition to a     carbohydrate-containing composition after work related depletion of muscle glycogen will     increase the rate of glycogen re-synthesis as compared with intake of the     carbohydrate-containing composition alone.   "
87095|NCT02146066|"     The study is an open-label expanded access study for patients for whom vaccine was     manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process,     but who subsequently failed to meet specific enrollment criteria. Patients will receive     therapy per investigator discretion (standard of care) as well as active vaccine per the     020221 protocol administration schedule. It is estimated that approximately 99 patients will     enroll in this study.   "
87130|NCT02145611|"     Cardiovascular disease is a major public health problem in our country. Among the causes of     cardiovascular diseases are High Blood Pressure (HBP) and Diabetes Mellitus (DM). Type 2     diabetes (DM2) is associated with a twofold risk of cardiovascular disease, and endothelial     dysfunction is an early marker of vascular complications. There is evidence of action of     glucagon-like peptide 1 (GLP-1) on endothelial cells and vascular smooth muscle. Vildagliptin     is a drug used in the treatment of DM2 able to prolong the activity of GLP-1, improving     glycemic control and endothelial function.      Objectives: To evaluate the effect of vildagliptin on endothelial function in patients with     DM2 and hypertension using the Endo-PAT 2000 device.   "
87087|NCT02146170|"     Background:      - Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one     million deaths every year. Researchers want to gather tissue samples from people with lung     and thymic cancers to understand the disease better. This may lead to new ways to diagnose     and treat it.      Objective:      - To collect tissue samples for use in the study of lung cancers.      Eligibility:      - Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary     small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.      Design:        -  Participants will be screened with a medical history, physical exam, and blood tests.          They will be asked about how they perform their daily tasks.        -  Participants may be asked to give urine and blood samples. They may give a saliva sample          if they cannot give blood. They will also give a sample of their tumor from a biopsy          they had. They may also be given the option to undergo a biopsy.        -  Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine          that takes pictures of the body.        -  After visits to the Clinical Center end, researchers will contact participants by phone          every year to check on their health.   "
87088|NCT02146157|"     This is a multi-center, randomized, double-blind, placebo-controlled study in approximately     104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination     product on fasting serum glucose levels in subjects with impaired fasting glucose. The study     consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible     subjects will be randomized to product to consume throughout the 12-week supplementation     period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.   "
87089|NCT02146144|"     The epimacular membrane (EMM) is a degenerative condition associated with age, with a     variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed     by a peeling of the epimacular membrane using a microgripper. Peeling of the internal     limiting membrane (ILM) is an adjuvant action that is now frequently practiced and which is     expected to increase the success rate of EMM surgery by reducing the risk of recurrence of     EMM. Although ILM peeling does not seem to have an adverse effect on visual acuity, it is not     totally without consequence, it involves the risk of histological disorganization of the     retina at the origin of one or several microscotomas, which are themselves responsible for a     final visual discomfort. These microscotomas, resulting in the perception of somewhat black     spots visible near the fixed point or the fixed image, may be highlighted by microperimetry     and would be a loss of functional opportunity for the patient.      In addition, recurrence of EMM, which the ILM peeling is supposed to diminish, does not alter     the vision in half the patients. Furthermore, for those patients who are functionally     affected by any such recurrence, a second epimacular membrane peeling surgery can be done.      The main objective of this study is to compare the difference in microscotoma(s) before     surgery and 6 months later, between an active ILM peeling group and a no ILM peeling     group. Given the more invasive nature of ILM peeling, the investigators believe that the rate     of microscotomas in these patients is higher than those without peeling.   "
87090|NCT02146131|"     The purpose of this study is to compare the yield of two methods for obtaining a lung tissue     sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure     #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound     (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look     inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a     technique that uses X-rays to see your lungs.      This will give the doctor an opportunity to use either of the bronchoscopy methods described     above and compare the tests to see if R-EBUS provides better results than standard     bronchoscopy.   "
87091|NCT02146118|"     1. Title and stage of study A Phase II Study to Assess Efficacy of Combined Treatment with          Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients with EGFR mutant lung          adenocarcinoma        2. Endpoints Primary Endpoint : tumour response rate Secondary Endpoint : progression-free          survival, overall survival, and safety assessment        3. Study Rationale Even though it is commonly accepted that EGFR TKIs are effective to EGFR          mutation positive lung cancer patients, still remains its resistance issue.           The Silybin which is extract from mugwort bean Thistle and used for hepatoprotective          drug for a long time with very low adverse events in Eastern countries. Recently, there          are some reports regarding its anti-cancer effects through several preclinical studies.           The safety of Siliphos which is developed agent from silybin for improving intestinal          absorption was demonstrated in PhaseⅠtrial.           Recently investigators found out Silybin is effective for blocking EGFR signal in          different mechanism from Erlotinib and it can be expected additional impact with          combination therapy with preclinical data.           Our research team can expect to improve Lung cancer treatment if the combination therapy          (Silybin_Erlotinib) improves patients' response and Overall survivor.        4. Treatment method Erlotinib (Tarceva 150 mg/day) and Silybin (Siliphos 1g bid/day) q 4          weeks        5. Assessment criteria For toxicity assessment, posttreatment recurrence and survival rates          will be investigated based on NCI-CTCAE ver 4.0 and RTOG. Efficacy assessment will be          conducted through measurement of lesions by CT and RECIST criteria. Overall survival          (OS), progression-free survival (PFS), and time to tumour progression (TTP) will be          estimated using a Kaplan-Meier analysis. In addition, effect of pre-treatment T790M on          response and PFS will be analyzed.   "
87092|NCT02146105|"     Keeping individuals with knee osteoarthritis physically active is critically important.     Exercise is effective at reducing pain while improving physical function. However some     exercises can overload the knee, and as a result, worsen knee pain and health of the knee     joint. Yoga offers a foundation of static postures that improve muscle strength and joint     flexibility. Using sophisticated technology that allows us to calculate the loads inside the     knee, the investigators have selected yoga exercises that do not overload the knee joint. The     investigators have designed a yoga exercise class that is ideal for people with knee     osteoarthritis. The purpose of the study is to investigate whether these yoga exercises     increase muscle strength and reduce knee pain in women with knee osteoarthritis. In addition,     the investigators aim to show that these yoga exercises will also improve knee loads during     activities, mobility and heart health. The investigators will ask 50 women with knee     osteoarthritis to participate in a 12 week yoga exercise intervention, that requires     attendance to 3 classes each week. The investigators will test strength of the leg muscles,     pain, knee joint loads, mobility and cardiovascular health before and after the 12 week yoga     exercise intervention.   "
87229|NCT02144324|"     An in vivo study evaluating the efficacy of the Tandem appliance in the treatment of     maxillary deficiency in growing patients compared to the conventional facemask appliance     treatment. Pre-treatment and post-treatment lateral cephalograms will be taken. Dentofacial,     sagittal and vertical skeletal measurements will be taken at three assessment times. Changes     within each group will be assessed. In addition, the changes between the two groups will be     compared.   "
87096|NCT02146053|"     Oral iron supplementation is often associated with rapid onset of gastrointestinal     side-effects. The aim of this study was to develop and trial a short, simple questionnaire to     capture these early side-effects and to determine which symptoms are more discriminating.      The study was a double-blind placebo-controlled randomized parallel trial with one week     treatment followed by one week wash-out. Subjects were randomized into two treatment groups     (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or     placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects     completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal     symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e.     nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).   "
87097|NCT02146040|"     The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment     in relation to thromboembolic events (stroke, and transient ischemic attacks) and     intracranial hemorrhage.      Primary Outcome Measures:      - Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to     diagnosis and anticoagulation treatment of AF during the study period; comparison of     complications between those with and without anticoagulation treatment according to CHADSVASc     score.      Secondary Outcome Measures:        -  The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes          within 30 days after anticoagulation pause and the prevalence of stroke and intracranila          bleeding in relation to INR level < 2, 2-3 and >3.        -  Trauma as a risk factor for intracranial bleeding: percentage and risk factors for          intracranial bleeding with or without trauma. Type of preceding trauma and type of          intracranial bleeding.        -  The time relation between diagnosis of AF and type of intracranial complications: Kaplan          Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding complications after          1st diagnosis of AF in patients with and without anticoagulation        -  The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED          score and anticoagulation/antithrombotic treatment        -  Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and          intracerebral bleeding in patients with and without anticoagulation        -  Factors related to underuse of anticoagulation treatment. Data on reasons for not          starting or stopping aticoagulation in those with indication of oral anticoagulation        -  Operations and procedure as risk factor for stroke: Frequency and type of operations          performed < 30 days before stroke. Data on length of perioperative pause in          anticoagulation and use of bridging therapy and timiing of stroke are collected.        -  Cardioversions as a risk factor for stroke: Frequency of stroke and TIA < 30 days after          cardioversion in relation to use of anticoagulation and CHADSVASc score        -  The risk of stroke and intracranial bleeding in relation to type of AF (permanent,          persistent, paroxysmal) and concomitant carotid disease      Estimated Enrollment: 6000 patients.   "
87098|NCT02146027|"     In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral     control after treatment with antiretroviral therapy will be enrolled to receive once a day     Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune     parameters will be monitored for 12 weeks in both arms.      The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T     cells immune parameters.   "
87099|NCT02146014|"     Tobacco addiction is treatable with behavioral and pharmacological means, but results are     often less than optimal. Transcranial direct current stimulation is a new non-invasive     technique that applies weak electrical currents through the skull and has been shown to alter     the excitability of certain brain areas. It is currently being tried in disorders where there     is abnormal brain excitability, such as epilepsy and depression. A few studies have also been     able to diminish drug craving, suggesting that brain excitability might also be altered in     drug addiction.      This study aims at non-invasively changing the excitability of certain brain areas-a     procedure called neuromodulation- in order to help smokers quit smoking more easily.   "
87100|NCT02146001|"     This study is a randomized trial that will compare the effects of two, 12-week activity     interventions on patterns of physical activity, physical health, and quality of life measures     in 40 older adults who are able to walk for exercise. One intervention will target 150     minutes per week of home-based moderate exercise (e.g. brisk walking), consistent with     current recommendations. The other intervention will target a decrease in time spent in     sedentary behaviors (e.g. sitting) of 60 minutes per day. Both interventions will wear an     activity armband which will allow them to self-monitor their activity or sedentary behavior     in real time using a smartphone. The armband will also provide objective data to an     interventionist that will facilitate the intervention. The main outcome will be time spent in     moderate exercise.   "
87101|NCT02145988|"     This is a prospective, randomized, double-blind, double-dummy, and controlled study of     DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral     arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin     treatment will augment significantly the resting ABI in diabetes patient with PAD in     comparison with that of aspirin alone.   "
87122|NCT02145715|"     Velcade (bortezomib), thalidomide and dexamethasone (VTD) has been demonstrated to be a     highly effective combination in both patients with previously untreated and those with     relapsed multiple myeloma. In previously untreated patients VTD demonstrated clear     superiority to TD as induction therapy prior to planned tandem autologous stem cell     transplant.      The rationale of this trial is to combine a 'gold standard' antiMM combination with the HDAC     inhibitor Panobinostat. There is emerging data to support the concept of clinical synergy     between BTZ and HDACi's.      The purpose of this study is to determine the maximum tolerated dose (MTD) and estimated     response rates of panobinostat, administered in combination with VTD, in subjects with     relapsed and relapsed/refractory multiple myeloma.   "
87102|NCT02145975|"     Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in     severe acute postoperative pain acts faster than its congener (morphine ) for pain relief .     In the literature there is no study that corroborates this theoretical assumption and     proposes to compare which has fewer adverse effects. This drug produces effects similar to     those reported for morphine but less magnitude and has the advantage that during the     postoperative period respiratory depression, antitussive effect , gastrointestinal discomfort     and physical dependence are manifested in a significantly less degree.      Trying to solve the management of postoperative pain relief , our objective is to determine     by controlled clinical trial of superiority if in adult patients undergoing surgery ,     fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia     care unit compared to morphine.   "
87103|NCT02145962|"     An open multicenter trial to document the efficacy and safety of two therapeutic Extremely     Low Frequency Magnetic Fields stimulation devices to promote wound healing of Diabetic Foot     Ulcers.   "
87155|NCT02145286|"     The purpose of this research study is to evaluate the safety and effectiveness of an     experimental procedure called Focused Radiation that may result in a faster way to plan and     deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous     tumors that originally came from another organ and have spread to bones). In this trial a     single fraction of radiation will be given from 8-15 Gray.   "
88515|NCT02127476|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's     Disease (AD) or Mild to Moderate AD.   "
87104|NCT02145949|"     As a function of the growing population of older adults, an estimated 3.48 million total knee     arthroplasty (TKA) procedures will be performed annually in the U.S. by 2030. Despite the     near-universal success of this surgery in mitigating chronic knee pain, TKA is not successful     in restoring long-term physical function in older adults, primarily because of quadriceps     muscle atrophy, which explains 77% of the strength deficits. Overall, strength and functional     mobility in TKA patients is 30-50% below age-matched healthy controls. Functional tasks such     as stair-climbing remain a clinical problem for 75% of patients following TKA. Muscle atrophy     occurs in both operative and non-operative legs, and is essentially permanent for older     patients because of their impaired ability to increase muscle mass. The purpose of this     clinical research is to determine the effects of essential amino acid (EAA) supplementation     on muscle mass, strength, and functional mobility following TKA in older adults. Based on     strong preliminary data, the investigators hypothesize that twice-daily ingestion of 20 g of     EAA for 1 wk before through 6 wk after TKA will increase basal rates of muscle protein     synthesis via inactivation of catabolic signaling, and up-regulation of anabolic and     cyto-protective proteins. The investigators further hypothesize that short-term atrophy     prevention and accelerated return of functional mobility will lead to longer-term structural     and functional adaptations, and improved quality of life in older TKA patients vs. Placebo.     Identifying the mechanisms up-regulated by EAA treatment that preserve muscle volume and     mobility will have a major impact on rehabilitation science. This study will accomplish two     specific aims: (1) determine if EAA elevates basal rates of muscle protein synthesis by     up-regulating anabolic pathways and cyto-protective proteins, and inactivating catabolic     pathways in the short term vs. Placebo and (2) determine if short-term prevention of atrophy,     weakness, and functional mobility leads to positive changes in muscle cell structure and     function, and improved quality of life in the longer term vs. Placebo. This work is     significant because it advances knowledge of the molecular and cellular changes occurring     during muscle atrophy (Placebo) and atrophy prevention (EAA) in a clinical setting using a     treatment that is broadly applicable, is well tolerated, and can be implemented immediately.   "
87106|NCT02145923|"     Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent     high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive     bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two     hours prior to autologous peripheral blood cells infusion. This is a single arm study with no     control. All patients receive cell therapy.   "
87107|NCT02145910|"     This phase I trial studies the best dose of vemurafenib when combined with whole brain     radiation therapy (WBRT) or stereotactic radiosurgery (SRS) in patients with v-raf murine     sarcoma viral oncogene homolog B (BRAF) mutation-positive melanoma and brain metastases.     Radiation therapy is an effective treatment for patients with brain metastases. Patients with     multiple metastases are typically treated with WBRT. For patients with a few metastases, SRS     alone can be used. Vemurafenib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Combining radiation treatment with vemurafenib for melanoma     patients with brain metastases may result in improved local control and prolonged survival.   "
87108|NCT02145897|"     Various preclinical animal studies have shown the potential of stem cells in re-vascularising     ischemic limbs and promoting collateral vessel formation. SVF have the potential to     facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical     studies indicate that stem-cell transplantation is feasible and may have beneficial effects     in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem     cells to home and differentiate on to this microenvironment. The increased vascular     permeability and expression of adhesion proteins like integrin assist in stem cell homing.     The migratory capacity of stem cells is dependent on natural growth factors such as vascular     endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor     (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular     tissue and is responsible for the recruitment of the stem cells to assist in the repair     mechanism and consequent improvement in limb function.      In addition to the above regenerating potential of SVF, they have several advantages; they     can be easily isolated without further culturing it. Most importantly SVF have shown to have     significantly highest expression of pluripotent markers similar to that of human embryonic     stem cells and yet they are non-tumorogenic and safe.      MSCs are having angiogenic activity and hence may be excellent source to develop     neo-vasculature and hence could be explored for their therapeutic potential for treating     Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules     involved with cell attachment to neighbouring cells and to the extra cellular matrix19     Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in     preclinical studies to be safe and effective.      The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal     stem cells is conducted with the broad objective of establishing safety and efficacy.   "
87109|NCT02145884|"     We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming     solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate     0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate     infantile hemangiomas.   "
87110|NCT02145871|"     The purpose of this study is to help us learn what is the best amount of fluid to give to     patients during bladder surgery in order to avoid delayed bowel function after surgery, which     could prolong hospital stay.   "
87123|NCT02145702|"     The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in     patients with end stage renal disease.   "
87124|NCT02145689|"     This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients     with upper limb spasticity.   "
87125|NCT02145676|"     This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper     limb spasticity.   "
87126|NCT02145663|"     The aim of this study is to establish diagnostic and predictive biomarkers for patients with     suspected acute stroke, that are transported by EMS as candidates for thrombolytic treatment.     The study focuses on the ultra acute phase, <4.5 hours from symptom onset, including the     prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2 peptide) and a     discovery phase for novel markers. Patient outcome will be evaluated at 3 month using the     modified Rankin Scale (mRS).   "
87129|NCT02145624|"     Due to an unexpectedly high number of infant deaths from whooping cough in 2012, the     Department of Health acted to protect newborns between birth and completion of primary     immunisations, the period with greatest risk of disease.      Vaccination of pregnant women with whooping cough vaccine in the third trimester of pregnancy     was instigated nationally, so that antibodies produced by the Mum would cross the placenta to     the unborn child, giving them passive protection at the most vulnerable time. This antibody     transfer has been known for some time but has not been compared between the two whooping     cough vaccines being used in pregnancy. Any effect the raised antibody might have on infant     responses to the vaccines given in the first few months of life has also not been measured.     This is particularly important as the infant immunisations include some of the same     components as the whooping cough vaccines, which include diphtheria, tetanus and polio.     Previous studies have shown that high levels of antibody prior to vaccination may affect     subsequent antibody responses. It is therefore important to assess whether administration of     the whooping cough vaccine in pregnancy adversely affects the protection afforded by the     infant vaccines, particularly to those which are similar, namely tetanus and diphtheria as     well as meningitis C and Hib vaccines which include diptheria and tetanus components in their     structures. This study will assess immune responses of mothers and their babies (~200 pairs)     to their vaccinations and will allow the comparison of two whooping cough vaccines being used     in pregnancy. This will be done by taking small amounts of blood, which is the only way to     measure antibody levels (the proxy of the immune response), before and after the     vaccinations. A group of unvaccinated women and their babies (50 pairs) will also be     recruited to allow comparison of their immune responses.   "
87178|NCT02144987|"     The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may     improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or     Atrophic Endometrium.   "
87111|NCT02145858|"     Postoperative bleeding is a common consequence after heart surgery which can significantly     impact outcomes and costs [Wynne R, Christensen MC, Dixon B]. When bleeding occurs, reliable     postoperative blood evacuation of the pleural, mediastinal and pericardial spaces with chest     tubes is imperative to facilitate pulmonary reexpansion and mediastinal decompression as the     patient recovers. When post operative blood evacuation is inadequate, retained blood     complications can result (herein described as the Retained Blood Complications (RBC). RBC is     the presence of post-operative pericardial and/or pleural fluid or blood that is diagnosed     and may necessitate drainage in the acute or subacute setting. The need for treatment and     interventions for these conditions represents an impediment to patient recovery and involves     both resource and economic consumption for a heart program and the healthcare system at     large. Clinically, Retained Blood Complications (RBC) can be recognized acutely or     subacutely. When it presents acutely, it is usually fresh thrombus around the heart or lungs     presenting as tamponade or hemothorax. When it presents subacutely, it results in bloody     pleural or pericardial effusions [Light RW, Light RW, Light RW, Ikaheimo MJ]. These effusions     are often driven by the breakdown of remaining thrombus. Once RBC occurs, subsequent     procedures may be needed to remedy it. A recent review of the literature indicated that     additional procedures for RBC are demonstrated in approximately 15% to 20% of patients after     heart surgery. In a prospectively collected United States Nationwide Inpatient Sample (NIS)     data from 2010, RBC could be demonstrated in 17% of patients. In this analysis, mortality was     doubled from 4% to 8%, length of stay was increased by 5 days, and average costs were 55%     higher. Patients with RBC, therefore, represent an increased at risk population for     complications and costs.      Postoperative obstruction of conventional chest tubes with blood and other fibrinous material     in the setting of postoperative bleeding contributes to RBC.(Shalli) In a recent study of     postoperative cardiac surgery patients at the Cleveland Clinic, 36% of patients were found to     have evidence of chest tube obstruction [Karimov JH]. Active Clearance with PleuraFlow has     been shown to prevent chest tube clogging, and reduce RBC. (Shiose, Arakawa, Perrault) The     purpose of this registry is to evaluate the effectiveness of PleuraFlow System, a commercial     Class II (US), Class IIb (Canada, Europe, and Australia), in the management of blood     evacuation after cardiac surgery. Additionally, the purpose is to educate about the incidence     of complications and post-surgical interventions consistent with Retained Blood Complications     (RBC) after adult cardiac surgery. The purpose of this registry is also to collect     post-market surveillance data on PleuraFlow ACT.   "
87112|NCT02145845|"     This study is intended to collect safety and effectiveness data on the Cook Injectable Small     Intestinal Submucosa (SIS)   "
87113|NCT02145832|"     This study is designed to determine whether micafungin is as efficacious as the current     standard of fluconazole, to compare the safety of the two drugs in the treatment of proven     neonatal candidiasis.      It is also designed to further elucidate the pharmacokinetics of the two products in the     growing and developing neonate and premature infant.   "
87114|NCT02145819|"     The aim of the study is to determine whether spontaneous LH peak is superior to human     chorionic gonadotropin before a transfer of a day 3 frozen embryo.   "
87115|NCT02145806|"     1. Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women        2. Evaluation the effect of urinary incontinence in pregnant and postpartum women.   "
87116|NCT02145793|"     Attention deficit hyperactivity disorder (ADHD) affects 8% of US youth. Even though evidence     shows medications are effective in reducing ADHD symptoms, many families experience ongoing     parenting stress around parent-child interactions. Children often have ongoing impairments in     functioning. ADHD is a common condition identified and managed by primary care pediatricians.     However current care in the clinic is not optimal to address parents' and children's needs     around ADHD chronic care. Time is the biggest barrier. Group visits are a viable option to     improve pediatric ADHD care, but requires extensive study. The goal of this proposed study is     to test the feasibility and effectiveness of the group visit model for ADHD management within     pediatric primary care. This study will be a randomized feasibility study that will generate     important pilot data, as well as result in an innovative, exportable pediatric ADHD group     curriculum for primary care practice.   "
87117|NCT02145780|"     Obesity is a complex and multifactorial disease representing a major public health challenge.     Indeed, overweight and obese people carry a major risk of developing insulin resistance and     type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to     counteract some of the mechanisms involved in the generation of insulin resistance. The model     of overfeeding represents a very good study model of the metabolic complications of obesity,     since it has been shown to induce a transient state of insulin resistance in the human.      The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric     needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on     insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on     post prandial partitioning of exogenous lipids after a test meal.      During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola     in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract     or with placebo.   "
87118|NCT02145767|"     Miscarriages and preterm births are common and serious events affecting women, families, and     healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth     is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key     role during pregnancy, has been proposed as a possible medication to be used in pregnancy to     prevent miscarriage and preterm birth among women who have bleeding in their first trimester     of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical     trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains     uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The     purpose of our study is to evaluate the effect of progesterone for the prevention of     miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a     clinical trial in which 850 women will be randomized to receive either progesterone     supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of     their pregnancy will be compared.   "
87119|NCT02145754|"     The main purpose of this study is to compare effectiveness of two different culture media for     cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from patients     with erythema migrans.   "
87120|NCT02145741|"     This open-label dose escalation phase I trial, 1280.15, is with the first administration of     BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale     behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese     patients with advanced solid tumours as weekly intravenous administration.   "
87121|NCT02145728|"     The purpose of this study is to evaluate whether individual cognitive functional therapy     (CFT), when compared to group exercise classes is effective in reducing pain and disability     in patients with non-specific chronic low back pain.   "
87127|NCT02145650|"     This study will examine the epidemiology (incidence and control of a disease), burden,     clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral     Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain     Injury (TBI).   "
87131|NCT02145598|"     This is a multicenter, randomized, blinded, 2-arm phase IIb trial that will compare the     efficacy and safety of Lenalidomide maintenance after Bortezomib/Melphalan/Prednison (VMP)     induction to VMP without maintenance (Placebo). In addition the trial will assess the     treatment of Revlimid/low dose Dexamethasone (Rd) as Salvage after VMP without sufficient     response (less than PR) in an observational arm. Key eligibility criteria include patients     with newly diagnosed multiple myeloma and who are 65 years of age or older or are not     candidates for high-dose chemotherapy and autologous stem cell transplantation. Patients with     poor performance status or serious coexistent medical conditions will be excluded from this     study. After registration all patients receive 6 cycles VMP (modified according to Mateos et     al.). Patients who receive at least a PR and completed VMP can be randomized to either     Lenalidomide 10 mg/d continuously maintenance or to placebo. Randomization will be stratified     according to the quality of response after VMP induction (PR vs. VGPR + stringent complete     remission [sCR] + CR). Patients that are not able to complete VMP due to toxicity but reached     at least a PR after a minimum of four cycles of therapy should immediately proceed to     randomization. Blinded phase continues until progression or end of study. After unblinding,     patients who received placebo should be treated with Rd.      Patients that do not reach PR after induction with VMP or are progressive during treatment     with VMP should not be randomized, but switched to the observation arm and treated with Rd     immediately. The study treatment ends with the confirmed progression on maintenance treatment     (Lenalidomide or placebo) for patients that reached PR with induction treatment, or with the     confirmed progression on second-line therapy with Revlimid® and Dexamethasone for patients     that did not reach PR on induction treatment. All patients will be followed up every 3 months     after end of study treatment, until end of study. The study ends two years after Last Patient     In (i.e. randomization for maintenance) if sufficient events for the primary endpoint were     received, but not later than 8 years after trial initiation (whatever comes first).   "
87132|NCT02145585|"     Closed loop systems for anaesthesia have been shown to be more efficient than manual     administration and than Target Control Infusion systems (TCI). So far, there is only one     single-center study demonstrating that a system using simultaneously three closed loops for     each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe     and is more efficient than manual administration of anaesthetic drugs. Although the results     of this study are very encouraging, they are limited by its sample of patients recruited for     non-cardiac surgery only.      The hypothesis of the present trial is that cardiac anesthesia using a completely automated     anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia     and muscle relaxation) is feasible, safe and reliable.      Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on     patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.      Hypnosis is monitored during the surgery according to the brain activity values provided by     an objective monitoring parameter, called Bispectral Index (BIS).      A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be     determined clinically by recording the % of sedation time during which the actual BIS is     within 10% of the target BIS (excellent control), within 11 -20% (good control), between     21-30% (fair control) and beyond 30% of target (inadequate control).   "
87133|NCT02145572|"     The purpose of this study is to identify unique metabolite signatures associated with the     development of Type 2 diabetes and diabetic kidney disease in children.      We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A)     in the urine of adolescent females with polycystic ovarian syndrome.   "
87134|NCT02145559|"     Given the role of mTOR signaling and probable synergistic activity of combining sirolimus and     metformin in patients with advanced solid tumors, the investigators hypothesize that:        1. The combination of metformin plus sirolimus will result in reduction of p4EBP1, p70S6K          and pAKT more than sirolimus alone in peripheral blood T cells (PBTC).        2. The combination of metformin plus sirolimus will result in decreased levels of serum          biomarkers including fasting insulin, C-peptide, glucose, triglycerides, LDH, IGF-1,          IGF-1R, IGF-BP and leptin, but an increase in adiponectin in peripheral blood.        3. Expression of active forms of AMPK, mTOR, PI3K, PTEN loss, AKT, LKB1, P62, LC3, and/or          ULK1 in the tumor tissue (original pathology) will be predictive of response to          combination therapy. This will be an exploratory hypothesis for this study.        4. Sirolimus induced toxicity, especially hyperglycemia and hypertriglyceridemia, will be          mitigated by combining sirolimus with metformin.        5. Metformin plus sirolimus will have promising anti-cancer activity and this activity will          correlate with decreases in the above biomarkers. This will be an exploratory hypothesis          for this study.   "
87135|NCT02145546|"     The current evidences indicate that ~30% patients with sick sinus syndrome(SSS) would develop     persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate     influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the     study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone,     Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including     the reduced AF burden (duration and episodes) and persistent AF free survival rate. All     patients will be followed up for 12 months.   "
90502|NCT02101476|"     The purpose of this study is to compare the analgesic efficacy of Xartemis 15mg/650mg by     mouth every 12 hours for the management of acute moderate to severe post operative pain to     generic Oxycodone/APAP(acetaminophen) (Percocet) 10mg/650mg by mouth every 6 hours.   "
87136|NCT02145533|"     An association between arterial aneurysms and matrix metalloproteinases (MMPs) has been     described previously. MMPs regulate extracellular structural proteins and tissue remodeling.     Neutrophil Gelatinase-associated Lipocalin (NGAL) is involved in the regulation of MMP     activity. The aim of this work was to study the relationship between the levels of MMPs and     NGAL and arterial aneurysms.      In a multicenter, open label, parallel groups, prospective study, patients with aneurysmal     disease were divided into two groups: Group I (with ruptured aneurysm) and Group II (with     non-ruptured aneurysm). Healthy volunteer patients were also enrolled and represented the     control group (Group III).      The investigators enrolled 307 patients (Group I: 107, Group II: 200) with arterial aneurysm:     49 popliteal, 31 common femoral, 2 superficial femoral, 29 common iliac artery, 3 common     carotid and 193 abdominal aorta. Finally, 11 healthy volunteer patients (9 males and 2     females, age range 40-70 year-old, median 56) were enrolled in Group III.      Elisa test and Western blot analysis revealed greater levels of immunoreactive MMP-9 and NGAL     in all patients with ruptured aneurysms, both central and peripheral aneurysms, and in the     aneurismal vessels.      These results provide important advances in the understanding of the natural history of     arterial aneurysms. MMPs and NGAL play a role in development of arterial aneurysms and they     may represent molecular markers for the prevention of aneurysmal rupture   "
87137|NCT02145520|"     In this study, investigators will compare the efficacy and safety of intravenous (IV)     Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of     hospitalization in admitted patients, as compared to placebo.   "
87138|NCT02145507|"     This study will evaluate a new blood collection and filtration system that is intended to be     used to collect, filter, separate and store red blood cells and, separately, plasma. The new     blood collection and filtration system will be compared to an already-approved and currently     used system. Further, this study will evaluate new processing conditions relative to the     individual components of the collection and filtration system. All study participants will     donate two units of whole blood with individual units being donated at least 56 days apart.     One unit of whole blood will be donated with the new system, and the other unit will be     collected with the already-approved system. A subset of the donors (approximately 24 of the     120 participants) will have a small quantity of their red blood cells injected back into     their body 42-days after they were donated in order to evaluate how well the red blood cells     survive. Blood and blood products from all donors will be analyzed the day of collection and     after storage (plasma after at least 30 days of storage and red blood cells after exactly 42     days of storage).   "
87139|NCT02145494|"     Giving a higher dose of radiation to the dominant tumour nodule within the prostate is     hypothesized to improve tumour control. This trial will assess whether this technique,     delivered in 5 treatments, can be delivered without increasing side effects.   "
87140|NCT02145481|"     The objective of the DeQCAD study is to measure the quality of the decision-making process     for patients with coronary artery disease (CAD) and Acute Coronary Syndrome (ACS) who are     making treatment decisions. In particular, this study is seeking to answer: a) How informed     are patients about their treatment choices, b) are patients participating in the     decision-making process as much as they would like to, and c) do the treatment decisions made     match patients' preferences?   "
87141|NCT02145468|"     Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with     Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing     understanding that the inflammatory response to ACS is integral to the subsequent evolution     of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an     enzyme which may play a central role in inflammation in the setting of heart attack.     Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent     plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and     thus reduce infarct size and the risk of subsequent cardiac events. This study will test     whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as     death, heart attack, or near heart attack requiring urgent treatment ) when started     immediately after ACS (specifically, heart attack). Patients who present with heart attack     and qualify for the study will be randomly assigned to receive 3 months treatment with either     losmapimod twice daily or placebo, which will be administered in addition to the usual     standard of care therapies for heart attack. Following the in-hospital period, subjects will     return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.   "
87142|NCT02145455|"     This study will compare two different surgical methods used in total knee replacement with     the Unity Total Knee Replacement System. The study will evaluate these two methods based on     patients' ability to perform various tasks prior to surgery and at 4 time points during the     first 12 months after surgery.   "
87143|NCT02145442|"     -  Obesity is an important and growing public health worldwide        -  Obesity is highly related to the development of metabolic syndrome, diabetes,          cardiovascular diseases and cancer        -  An extensive body of evidence from efficacy trials has shown that weight loss is          achievable, however, a modest weight loss is achieved in a small proportion of patients        -  Important adverse events have been reported with the use of antiobesity drugs.        -  The use of natural products with potential effects inducing weight loss is an          alternative strategy for treating patients with overweight and obesity. However,          efficacy and safety should be evaluated in RCT.        -  Obex combines different molecules with potential effects inducing weight loss and          control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.        -  Therefore, the administration of Obex in overweight and obese patients with impaired          fasting glucose could be an excellent strategy to induce weight loss and ameliorate the          metabolic disturbances related to obesity and overweight.   "
87176|NCT02145013|"     According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating     cirrhosis is restricted to patients with preserved liver function, single nodule without     vascular invasion and with hepatic venous gradient below 10 mmHg.      However, other guideline treatment, especially from eastern countries demonstrated that     surgical resection is safe and feasible and provides better survival than the treatment     recommended by the BCLC system for patients with similar stage.      The primary goal of this study is to assess the impact of HVPG on short and long-term     outcomes in HCC patients who undergo liver resection.   "
87144|NCT02145429|"     This study is being conducted in GOA India. The study addresses specific issues of depression     prevention in older adults living in low- and middle income countries (LMICs), by developing     risk-reduction strategies through the use of lay health counselors. We will be training Lay     Health Counselors (LHC's) to deliver simple behaviorally oriented interventions, designed to     enhance the ability to relax, to improve active coping via better problem solving, and to     increase protective factors such as good quality sleep. Lay Health Counselors are inhabitants     of Goa.      The aim of phase 1 is to create a depression and anxiety prevention intervention for use by     lay health counselors. We will test the feasibility and acceptability of Problem Solving     Therapy for Primary Care (PST-PC) and Brief Behavioral Treatment for Insomnia (BBTI). The     products of phase 1 will be a prevention and counseling manual to standardize the     implementation of the interventions for further testing in a randomized prevention trial     (Specific Aim 2) and the adaptation of PST-PC and BBTI for the Indian population.      In Phase 2, we will: gather data on the feasibility of identifying, enrolling, randomizing     and retaining participants; implement the experimental intervention and enhanced usual care;     identify real world, barriers and develop strategies for addressing them; and assess the     fidelity of the interventions.   "
87945|NCT02134938|"     The purpose of this study is to assess whether low caloric, low energy density, konjac food     products are effective in appetite regulation when administered as caloric replacements. It     is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food     products will have comparable satiety scores, decreased postprandial glucose response, and     will not significantly affect subsequent food intake.   "
87145|NCT02145416|"     This is a single arm, single centre imaging study which will be offered to all consecutive,     eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within     Oxford University Hospitals.      Investigations        -  Dynamic contrast enhanced magnetic resonance imaging (DCE MRI)        -  Diffusion weighted magnetic resonance imaging (DWI MRI)        -  MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI)        -  MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI)        -  Perfusion computed tomography (pCT)        -  Fludeoxyglucose positron emission tomography (FDG PET/CT)      Study Design: Observational      Target Population: Patients undergoing radical CRT for anal cancer in Oxford University     Hospitals National Health Service (NHS) Trust.      Duration on study: Patients should be on study for a maximum of 5 months.      Patient care post-trial: Follow up as per local standard.      No. of Study Site(s): Single Centre, United Kingdon (UK)      End of study: Last Patient, last assessment of response. Patients should be on study for a     maximum of 5 months.   "
87146|NCT02145403|"     The investigators hypothesize that adding carfilzomib to standard conditioning regimen for     allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant     relapse and treatment-related mortality by decreasing severe GVHD, leading to overall     improvement in transplant outcomes.   "
87147|NCT02145390|"     Bladder preservation in patients with complete response after neoadjuvant chemotherapy will     lead to equivalent or superior relapse free rates compared to cystectomy rates from     historical controls.   "
87148|NCT02145377|"     To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo     to elicit a significant antibody response 14 days after vaccination, compared to baseline.      To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two     dose administration, to elicit antibody response by 14 days after vaccination.   "
87149|NCT02145364|"     This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20     subjects will receive study treatments. Following study treatments, follow-up visits will     occur at 60, 90 and 180 days from each subject's last study treatment.   "
87150|NCT02145351|"     Determine the impact of restoring normal heart rate response during exercise and daily     activity in patients with heart failure and a preserved ejection fraction (HFpEF) and     chronotropic incompetence (CI).   "
87151|NCT02145338|"     This research project is designed to find out whether people who suffer repeated urinary     tract infections (UTI) related to the need to empty their bladders intermittently with a fine     plastic tube (catheter); a process called clean intermittent self-catheterisation (CISC),     benefit from taking continuous daily low-dose antibiotics (antibiotic prophylaxis). The     investigators estimate that about 40,000 people in the United Kingdom need to use CISC     regularly to empty their bladder either because of nerve damage such as multiple sclerosis or     because of failure of the bladder muscle to contract, and of these about 25% (10,000 people)     suffer frequent UTI. One way to reduce this problem may be to take a small daily dose of     antibiotics and the study aims to find out whether such treatment is effective and worthwhile     both for the people who suffer the problem and for the National Health Service (NHS).      The two options to be compared in the trial are firstly, a once daily preventive dose     (prophylaxis) of an antibiotic routinely used for this purpose (either nitrofurantoin or     trimethoprim or cefalexin), and secondly no prophylaxis. The investigators think that an     overall decrease of 20% or more in the frequency of UTI would be large enough for future     patients using CISC who get troublesome recurrent UTIs to be offered antibiotic prophylaxis     routinely. The investigators will also assess any harm caused by continuous use of     antibiotics, particularly side effects for those people taking them and changes in the     resistance of bacteria to these antibiotics. The investigators can then work out whether the     balance between the benefits and harms make the use of prophylaxis worthwhile to people     carrying out CISC and for the NHS as a whole.   "
87152|NCT02145325|"     Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have     been demonstrated to broadly control T cell reactivity (14). Importantly, Tregs have been     shown to control immune responsiveness to alloantigens and significantly contribute to     operational tolerance in transplantation models (15, 16). However, there have been limited     efforts to harness the therapeutic potential of directly isolated CD4+CD25+ Treg cells for     controlling graft rejection and inducing transplantation tolerance, such as for kidney     transplants. In order for CD4+CD25+ Treg cells to be used as a clinical treatment, the     following cell properties could be necessary: ex vivo generation of sufficient numbers of     cells, migration in vivo to sites of antigenic reactivity, ability to suppress rejection in     an alloantigen-specific manner, and survival/expansion after infusion for a critical, but     currently unknown, period of time. Our published work and that of other investigators has     demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of these cells to     downregulate allogeneic immune responses in vitro, and 3) the efficacy of Treg for prevention     of allograft rejection in animal models (15,16). We have developed strategies for the ex vivo     expansion of naturally occurring human Tregs (nTregs) that allow for the practical employment     of this cellular therapy in the clinic. Our central hypothesis is that sufficient human nTreg     can be expanded ex vivo and used to both prevent renal transplant rejection and facilitate     the reduction and subsequent withdrawal of drug-based immunosuppression. This study will     allow for us to define the safety of Treg adoptive cellular transfer (TRACT) in living donor     renal transplant recipients that draws upon our extensive preclinical experience with     expanded Tregs, as well as our recognized clinical expertise with designing immunosuppressive     regimens compatible with this type of therapeutic cell transfer.   "
87153|NCT02145312|"     One promising approach to the treatment of cancer is inhibition or modulating the crucial     signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the     clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an     alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell growth     inhibition and induction of apoptosis. We suggest multicenter single arm phase II study to     determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic SCCHN who     failed to prior chemotherapy regimens. Enrollment will be done in 5 or more clinical trial     centers in Korea. Primary objective is to evaluate disease control rate (DCR) at 8 weeks of     BYL719, and the efficacy will be evaluated by the investigators analysis based on RECIST     version 1.1.   "
87154|NCT02145299|"     This is a prospective, multicenter, randomized, single-blind study enrolling up to 75     subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO     will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the     CROSSER™ CTO device (Control). All patients will receive standard anticoagulation per     hospital protocol and antiplatelet therapy with aspirin and clopidogrel.   "
88661|NCT02125578|"     The primary objectives are to identify the highest safe and well-tolerated dose and frequency     of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of 63 to 188     mcg, when given every other week or every 4 weeks to healthy volunteers (HV).   "
87156|NCT02145273|"     Maternal depression is a pervasive problem that disproportionately affects low-income     mothers. The effects of depression on mothers and their parenting result in many negative     outcomes for children, particularly in terms of school readiness. The proposed research will     build on a successful partnership between the University of Southern California School of     Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an     evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start     mothers with depression or dysphoric mood with the goal of reducing their depression and     promoting positive changes for both mothers and children. The objectives of the study are:     (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G     via a randomized controlled trial in Head Start centers in Los Angeles County operated by     CII; (3) evaluate the effects of the intervention on maternal depression, parenting     behaviors, goal-directed behavior, interpersonal relationships, physical health, and child     behavior and school readiness; and (4) develop a manual for use of the intervention in Head     Start and disseminate findings nationally. The study will feature 2 groups of 60 mothers     each, randomized by Head Start site; one will receive the intervention and the other services     as usual. Outcomes for both mothers and children will be tracked for 2 years after the     intervention, allowing for the evaluation of short- and long-term effects. The intervention     will be delivered by Head Start mental health workers under the supervision of Scott Stuart,     a national trainer of the intervention. This intervention has the potential to be a low-cost,     high-impact intervention that can be replicated to other Head Start sites across the country     to improve the lives of Head Start children and families.   "
87157|NCT02145260|"     Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure     that cause symptoms and/or require an intervention. They are common, affecting up to one     third of maintenance HD sessions. Detrimental associations include: development of myocardial     stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality.      Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular     and intra-cellular compartments, promoting trans-cellular fluid movement and resultant     hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may     ameliorate excess SBP decline during HD.      This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L)     dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on     intra-dialytic blood pressure and biomarkers of cardiac ischemia.      The investigators will randomly assign subjects to higher versus lower DNa during their     hospital stay, up to a maximum of six HD sessions.   "
87158|NCT02145247|"     Women with PCOS suffer from excess male hormone (androgen) production by the ovary. Androgen     is made by cells that surround follicles that contain eggs. As the follicles (and eggs) grow     and mature, there are more androgen producing cells. Women with PCOS have more follicles than     normal women and therefore more androgen producing cells. While androgen production has been     associated with the number of follicles, the relationship to the individual size of follicles     in PCOS or normal women. This study intends to determine whether the size and number of     ovarian follicles are correlated to androgen production in PCOS and normal women.   "
87159|NCT02145234|"     The purpose of this study is to evaluate the safety, tolerability, immunogenicity,     pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy     adult subjects.   "
87160|NCT02145221|"     The investigators are studying music therapy as an incentive and adjunct to a comprehensive     spine surgery rehabilitation-recuperation program. Through the use of music therapy     psychosocial support is motivated by the clinical use of music. The program will investigate     the use of music therapy as an option for managing symptoms associated with spine surgery     recovery. The proposed program will investigate the use of music therapy as an integrative     treatment within Beth Israel's Department of Spine Surgery.This study will investigate the     effects of music therapy in managing spine surgery recuperation and to reduce the intensity     and experience of pain. Outcomes will include: Pain (pain medication dosage and patient     report) using a CAS Color Analysis Scale and the VAS Pain Rating Scale, level of     self-reliance/independence using physical therapy assessment scale, cooperation through     evaluating number of times patient declined/accepted services, length of stay, patient     satisfaction/patient report, level of kinesiophobia using the Tampa Scale for Kinesiophobia     and anxiety/depression using the HADS during the period post-spine surgery.(see attached     scales in Appendix section)   "
87161|NCT02145208|"     The study will include an implantation of the TIND device and 4 follow up visits up to 12     months after the implantation.   "
87162|NCT02145195|"     The main purpose of this study is to investigate whether and in which doses vitamin D intake     is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children     during wintertime.   "
87163|NCT02145182|"     The purpose of this study is to determine if Eculizumab is safe and could be used to prevent     delayed graft function following kidney transplantation.   "
87188|NCT02144857|"     Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators     investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction     and myocardial dysfunction are impaired in patients with psoriasis compared to normal     controls ,coronary artery disease patients and untreated hypertension subjects. The     investigators also examined the effect of treatment with biological vs no biological agents     on vascular and LV function in psoriasis.   "
87164|NCT02145169|"     To describe the safety and efficacy of nitrous oxide during ketamine administration for the     prevention of emergence reaction during Emergency Department procedural sedation and     analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in     emergency departments for procedural sedation and analgesia because they have a rapid onset     and short duration of action. Unfortunately, all of these agents may cause respiratory     depression, particularly when combined with other sedative agents, administered in large     doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during     ketamine administration may be an ideal combination for the prevention of emergence reaction     in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory     profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding     procedural sedation is not limited to the procedure itself, but the elapsed time from the     time the patient enters the ED to the time spent in preparation for the procedure can be     significant and lead to increased anxiety, which may exacerbate emergence reactions in     adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam     has shown efficacy in reducing emergence reactions in adults sedated with ketamine, the     investigators believe that inhaled nitrous oxide may be equivalent to midazolam, with a     better cardio-respiratory profile.   "
88676|NCT02125383|"     The purpose of this study is to evaluate the effects of transcranial direct current     stimulation (tDCS) on patients with Parkinson's disease during sleep.   "
87165|NCT02145156|"     The purpose of this study is to evaluate an innovative approach to improving HPV vaccination     among the Hispanic population. The clinical objectives/aims of this HPV educational     intervention project are to determine:        1. The number of young adults and adolescents in each arm who received any dose of the HPV          vaccine during the study period,        2. The number of young adults and adolescents in each arm who initiated the HPV vaccine          series during the study period,        3. The number of young adults and adolescents in each arm who initiated but did not          complete the HPV vaccine series during the study period,        4. The number of young adults and adolescents in each arm, among all eligible, who          completed the HPV vaccine series during the study period,        5. The number of young adults and adolescents in each arm who completed the HPV vaccine          series during the study period, among those who initiated the series at study start, and        6. The number of young adults and adolescents in each arm who completed the HPV vaccine          series among those who initiated the series during the study period.      The implementation of this educational intervention in clinic waiting rooms is intended to     assist primary care providers in communicating HPV vaccine awareness and education to parents     and patients in a culturally tailored format.   "
87166|NCT02145143|"     The purpose of this study is to find out what effects, good and/or bad, a drug called     vemurafenib, either alone or combined with another treatment called radioactive iodine, has     on the patient and thyroid cancer. It is not known if vemurafenib works against thyroid     cancer. This study will test in a small number of patients if it can be used with radioactive     iodine to treat thyroid cancers. This type of study is called a pilot study. If the results     are positive, a larger study with more patients may be done to further test this treatment.   "
87167|NCT02145130|"     The purpose of this study is the evaluation of the safety of autologous tissue-engineered     dermal substitutes denovoDerm (first arm) and dermo-epidermal skin substitutes denovoSkin     (second arm) transplanted onto the wound bed in children and adults.   "
87168|NCT02145117|"     This project aims to develop and test structural and functional brain imaging biomarkers for     improvement in chronic pain from a mind/body intervention perspective in a critical veteran     population, namely veterans with post traumatic headache (PTH) associated with mild traumatic     brain injury (TBI). The project also aims to examine feasibility in a sample of veterans with     PTH of performing resting state and structural neuroimaging protocols, and of obtaining     active participation and completion of MBSR training. Lastly, exploratory analysis of brain     imaging data will be performed to determine if hypothesized candidate biomarkers are     associated with positive outcomes from MBSR and determine estimated effect sizes for future     studies in PTH population.   "
87169|NCT02145104|"     The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus     valsartan and valsartan alone in patients with essential hypertension inadequately controlled     on valsartan monotherapy   "
87170|NCT02145091|"     This is a double-blind placebo-controlled study investigating the acute and persisting     effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes,     and brain functioning.   "
87171|NCT02145078|"     This pilot clinical trial studies whether the levels of certain genes in the tissue and blood     are related to how well patients with stage IV non-small cell lung cancer respond to     chemotherapy. Genes may affect how sensitive or resistant tumors are to chemotherapy.     Studying the levels of genes related to tumor response before and after chemotherapy may help     doctors learn whether they can predict how well patients will respond to treatment.   "
87172|NCT02145065|"     The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of     the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment     of femoropopliteal artery disease.   "
87173|NCT02145052|"     The primary objective of this study is to identify the optimal method of fascial closure of a     laparotomy incision in high risk patients for intra-abdominal complications. The     investigators hypothesize that interrupted closure is associated with decreased complication     rates when compared with running/continuous closure. Secondary objectives are to determine     the rate of dehiscence in continuous and interrupted suture technique, and to determine the     rate of wound infection, hernia formation, and mortality associated with suture technique.   "
87174|NCT02145039|"     This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant     (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of     fludarabine, cyclophosphamide and low dose total body irradiation (TBI), is designed for the     treatment of patients with advanced and/or high risk diseases.   "
87175|NCT02145026|"     This is a phase IV, prospective, multi-center, open-label study to assess the effectiveness     and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult     participants associated with low/intermediate-1-risk MDS. After screening, eligible     participants will be treated with epoetin beta as recommended in the approved label and     international guidelines for the use of epoetin in MDS participants and the dosage will be     adjusted on the basis of erythroid response.   "
87177|NCT02145000|"     The study is a double-blinded, randomized, placebo-controlled, trial with two groups of     infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses     of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be     administered at 4 week intervals between doses. The first administration will occur at 6-8     weeks of age.      We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo     against severe rotavirus gastroenteritis in healthy infants in Niger.      Active surveillance for gastroenteritis episodes will be conducted throughout the trial.     Surveillance for adverse events will be carried out among all children from the time of first     vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including     intussusception and death, will be conducted on all participants until they each reach two     years of age.      To assess the effect of prenatal nutrition supplementation on infant immune response to the     BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1     ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a     lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of     age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter     the main trial as part of the immunogenicity sub-cohort.   "
87179|NCT02144974|"     Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative     intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical,     or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several     options for pelvic floor and vaginal reconstruction have been described. The transverse     musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free     flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE.      Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction     with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had     vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative     procedure and the outcome of the operation in these patients.   "
87180|NCT02144961|"     The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine     green angiography (IGA) on both flap design and rate of post-operative fat necrosis in     patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric     Artery Perforator (DIEP) flap.   "
87181|NCT02144948|"     This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to     antidiabetic standard care in patients with diabetes mellitus type II   "
87182|NCT02144935|"     Patients and families are invited to participate in an online registry and data repository     specifically for patients with transverse myelitis. Their options are to join the data     repository only, or participate in a clinical sub study in conjunction with the database     repository. The data generated in this study will come from surveys, interviews, review of     medical records, and physical examinations.      Data from this study will be utilized to guide future clinical trials for children with an     acute case of Transverse Myelitis. Parents and children separately will fill out an online     data base with 7 banks of surveys, each bank of survey topics have 7-10 questions. We will     have both the parent and child fill out at time of symptom onset, and three time points to     follow, 3, 6, and 12 months post symptom onset.      A small subset of patients filling out the data registry will be able to travel to 1 of 5     treating TM centers; Children's Medical Center Dallas, Children's Hospital of Philadelphia,     Hospital for Sick Children (Toronto, CA), Kennedy Krieger Institute, or Johns Hopkins     University in Baltimore, MD for a physical examination highlighting recovery from Transverse     Myelitis.   "
87183|NCT02144922|"     Although statins reduce cardiac events in hypertensive patients with cardiovascular risk     factors, the effect of statins on coronary flow reserve (CFR) has not been examined in such     patients. The investigators hypothesize that pitavastatin added to standard antihypertensive     therapy will be superior to placebo in improving CFR in hypertensive patients with     cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized     comparison study using Doppler echocardiography.   "
87184|NCT02144909|"     The investigators are conducting a feasibility study using a randomized controlled trial     (RCT) design in which participants will receive the Partners in Care (PIC) diabetes     self-management intervention and then be randomized to either semi-structured social support     or a standard follow-up control group. Participants in the support groups will receive a     culturally-tailored, semi-structured social support program delivered in a community setting     by trained community peer educators and other health professionals (e.g., pharmacist). The     investigators believe that the addition of a semi-structured social support component as a     supplement to an evidence-based diabetes self-management intervention will improve diabetes     self-care maintenance.   "
87185|NCT02144896|"     Endothelial function of the skeletal muscle vasculature declines with advancing age. Although     aerobic exercise training is commonly prescribed to combat loss of endothelial function in     the elderly, the rate of compliance to training programs is low. Contrary to aerobic exercise     training, stretching exercise is widely performed in elderly patients to increase muscle     flexibility and to prevent muscle atrophy induced by immobilization. However, it remains     unknown as to whether regular stretching of the calf muscles using ankle dorsiflexion     splinting improves muscle blood flow. The purpose of the proposed work is to test the     hypothesis that performance of ankle dorsiflexion splinting improves endothelial function and     lower leg muscle blood flow in older adults. Ankle dorsiflexion splinting will be performed     on the randomized leg for 30 minutes, 5 times per week for 4 weeks. Leg vascular measures     will be performed on the splinted and non-splinted legs prior to and at the end of the 4-week     intervention.   "
87186|NCT02144883|"     This purpose of the study was to investigate the efficacy of telephone counseling to help     pregnant women quit smoking. The investigators tested two hypotheses: 1) telephone counseling     increases the overall cessation rate during pregnancy, and 2) the counseling effects can be     maintained postpartum.   "
87187|NCT02144870|"     The main purpose of this study is to evaluate the efficacy of a habit reversal based     treatment programme compared to an alternative treatment which aims at the activation of     resources in children and adolescents aged 8 to 18 years with tic disorders.   "
87189|NCT02144844|"     The hypotheses were as follows:      H1. Women at low-moderate risk for APD at T1 (baseline EPDS scores of 5-9) in the cognitive     behavioral intervention (CBI) group will maintain low-moderate risk status and have     significantly fewer APD symptoms at T2 and T3 than women at low-moderate risk for APD in the     (TAU) control group (as measured by percent of participants with EPDS scores <9 at T2 and T3     and mean score changes).      H2: Women at high risk for APD at T1 (baseline EPDS scores ≥10) in the CBI group will have a     significantly greater reduction in APD symptoms at T2 and T3 than women at high risk for APD     in the TAU control group (as measured by percent of participants with EPDS scores <10 at T2     and T3 and mean score changes).   "
87190|NCT02144831|"     The primary goal of the research is to determine if 10 days of dual anti-platelet treatment     is as effective as 30 days of similar treatment in the prevention of stroke, myocardial     ischemia (MI) and death in patients with TIAs and minor stroke.   "
87202|NCT02144675|"     This randomized phase II trial studies how well choline magnesium trisalicylate with     idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used     in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. It is not yet know whether choline magnesium trisalicylate and     combination chemotherapy is more effective than combination chemotherapy alone in treating     patients with acute myeloid leukemia.   "
87191|NCT02144818|"     During the last decades, owing to the growing tendency of women to delay childbearing plans     because of career and personal priorities, fertility specialists today are seeing more and     more women with poor ovarian reserve and with poor ovarian response Controlled ovarian     hyperstimulation (COH) is considered a important factor in the success of in vitro     fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and,     thereby, resulting in more than one embryo. However, owing to the extreme variability in     ovarian response to COH, in a subgroup of patients with poor ovarian response, this method     may yield a very small number of follicles After succeeding in maximal recruitment of the     follicles, the triggering of ovulation is extremely important in order to achieve, as many     as, mature oocytes.      Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering     compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH     agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role     of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH receptor     formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation and     cumulus expansion .      Another method described to trigger ovulation is the Dual triggering- GnRH agonist 40 h     prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was     described as the treatment in cases with recurrent empty follicles.      The aim of the present study is to evaluate three different methods of ovulation triggering     in women with poor ovarian response   "
87192|NCT02144805|"     The study compares short-term and long-term effects on myometrial thickness in women sutured     by single- or double-layer technique by closure of cesarean uterine incision. The study is a     randomized clinically controlled study.   "
87193|NCT02144792|"     The major hypothesis explaining drug resistance is overexpression of p-glycoprotein at the     target lesion. Based on several studies, p-glycoprotein (P-gp) has an important role in     neurologic diseases, especially in drug resistant epilepsy. But there is no surrogate marker     that can quantify the expression of P-gp because of the difficulty in measuring substances in     the neurologic system and the lack of clinical trials. Here, the investigators use a novel     non-invasive [11C] -verapamil Brain PET and SPAM analytic method as a surrogate marker for     quantifying the expression of p-glycoprotein.   "
87194|NCT02144779|"     This project is evaluating the effect of a standardized communication intervention in the     pediatric intensive care unit (PICU) on long-term distress of family members of children in     the PICU for 5 days or longer. The study hypothesis is that intervention families will have     lower (better) acute stress disorder scores when their child is discharged from the PICU and     lower (better) post-traumatic stress disorder scores at 3-month follow-up, as compared to the     control group families. The investigators will recruit 220 families (110 in each of the     control and intervention groups). Families who are randomized to the intervention group will     receive routine visits from members of the PACT (palliative care) team at least three     times/week to address psychosocial needs, keep families informed about their child's health     status, and offer emotional and instrumental support and resources. Families in the control     group will receive usual care in the PICU. The intervention will end whenever the child is     discharged from the PICU, which usually happens within 3 weeks of enrollment. The     investigators will assess family outcomes at discharge from the PICU and 90 days after study     enrollment. The investigators will conduct two additional activities to learn more about the     processes of care for those in both the intervention and control groups. First, during the     intervention, the investigators will recruit 30 families (15 in each group) and ask     permission to audio-record the family care conferences to assess communication styles and     gain greater insight into the differences in practice with or without the participation of     the intervention team. The investigators will obtain additional consent from participants in     these family conferences who are not otherwise enrolled in the study. Second, after     completion of the 3-month follow-up interview, a sub-sample of a different 30 families     (again, 15 in each group) will be invited to participate in qualitative interviews to debrief     about their experience in the study and the intervention (for those in that group). This will     be a one-time interview scheduled within 60 days of recruitment for this part of the project.   "
87195|NCT02144766|"     The goal of the present study was to investigate the role of pro-inflammatory cytokines in     myocardial dysfunction and injury resulting from noncardiac injury in children and whether or     not anti-inflammatory treatment with caudal block prevents pro-inflammatory     cytokines-associated myocardial dysfunction and injury following noncardiac surgery.   "
87196|NCT02144753|"     The objective of this Phase II trial is to test the NTX-1 Fiber in patients with     constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially     modify gut microbiota composition, and improve gut milieu in these patients. The     investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e     has less side effects) and is more effective than psyllium (the most commonly used fiber in     the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in     those with dysbiosis and low SCFA levels.   "
87197|NCT02144740|"     Part 2 of the study will assess the effect of 2g of NWT-03 (an egg-white protein hydrolysate)     on systolic and diastolic blood pressure and flow-mediated dilation in a crossover designed     study in healthy adults with mild hypertension.   "
87198|NCT02144727|"     In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric     cancer in advanced gastric cancer (stage IB/IIA/IIB ).   "
87199|NCT02144714|"     The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and     immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy     subjects.   "
87200|NCT02144701|"     This randomized pilot clinical trial studies Lactobacillus rhamnosus GG in reducing incidence     of graft-versus-host disease in patients who have undergone donor stem cell transplant.     Lactobacillus rhamnosus GG may be effective at preventing for graft-versus-host disease     caused by a donor stem cell transplant.   "
87230|NCT02144311|"     The purpose of this research study is to learn if differences seen in scans before surgery     match differences seen when looking at tumor samples with pathology and genetic tests. In     this study we will use Magnetic Resonance Imaging [MRI] and Positron Emission Tomography     [PET] scans. No direct clinical benefits will come from the results of this study.   "
87201|NCT02144688|"     The purpose of this study is to contribute evidence towards the potential to improve     cognition in HIV+ individuals experiencing cognitive decline through personalized change in     antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to     identify confounding clinical conditions, study participants will undergo a lumbar puncture     to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype     and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from     the CSF analysis, a personalized change in ARV will be implemented. Cognition will be     measured in all at study entry and 6 months later.   "
88694|NCT02125149|"     The purpose of the study is to determine how a mother's health and physical activity may     influence her child's growth and development.   "
87203|NCT02144662|"     Primary Objective: To investigate the pretreatment quantitative factors as shown in SD-OCT     images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis     (Ranibizumab) for RVO.      Secondary Objectives: Correlations between posttreatment BCVA and pretreatment factors were     evaluated, including age, pretreatment BCVA, photoreceptor outer segment (PROS) length,     central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer     thickness (ONLT). The factors influencing posttreatment BCVA were evaluated using multiple     regression analysis.      Detailed information on macular morphology, such as the photoreceptor IS/OS junction and ELM,     can be obtained in SD-OCT. Some OCT studies evaluated other quantitative factors in eye     disease. It was reported that PROS length was correlated with BCVA in patients with DME.¹     Other investigators suggested that the thickness, area, and volume of the outer layer were     correlated with BCVA in patients with dry age-related macular degeneration (AMD).² Outer     foveal thickness (OFT) and relative reflectivity of the outer nuclear layer (ONL) were     associated with BCVA in patients with macular hole.3, 4 The volume of the ONL was found to be     associated with BCVA in patients with AMD.5 The aim of this study was to investigate the     pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment     VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.   "
87204|NCT02144649|"     This randomized pilot clinical trial compares tangerine and red tomato juice in treating     patients with prostate cancer undergoing surgery. A diet high in lycopene, a substance found     in tomatoes, may help prevent normal cells from transforming into cancer cells in patients     with prostate cancer.   "
87205|NCT02144636|"     This randomized control trial of diet with protein supplementation is being conducted to test     the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss     and improvement in cardio-metabolic profile.   "
87206|NCT02144623|"     This trial includes patients with chronic lymphocytic leukemia, the most common kind of     malignant lymphoma. Monoclonal antibodies directed against cluster of differentiation antigen     20 have improved treatment results in different forms of lymphomas; however in chronic     lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it has been     suggested that this is depending on a lower expression of the cluster of differentiation     antigen 20 protein on the chronic lymphocytic leukemia cells.      Valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation     antigen 20 expression, and the rationale in this study is that an increasement of cluster of     differentiation antigen 20 would make treatment with monoclonal antibodies in patients with     chronic lymphocytic leukemia more effective.   "
87207|NCT02144610|"     Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.   "
87208|NCT02144597|"     Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat     content and size thereby improving surgical outcomes. This study aims to investigate whether     a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat     further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI).     The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further     than the conventional food pre-operative diet.   "
87209|NCT02144584|"     This will be a randomized double blind placebo-controlled pilot study using a repeated     measures design in which participants with acute ischemic stroke and upper extremity weakness     are randomized to either drug or placebo   "
87210|NCT02144571|"     It is known that diet and physical affect a variety of disease-related endpoints and overall     health status in general. The investigators also know that dietary and PA intervention     effects are difficult for individuals to maintain. By contrast, the investigators have some     evidence that group-based and family-centered, multi-component interventions are more     effective in terms of creating large changes in diet-related outcomes. Using a     group-randomized, controlled design, the overall goal of this project is to reduce breast     cancer-related health disparities in a high-risk community, by achieving these Primary     Aims,to conduct a regionally-based community-designed dietary and physical activity     behavioral controlled trial among AA women,to test the effectiveness of the     community-designed, family-based dietary and physical activity behavioral intervention on     modifying biomarkers of inflammation and to test the effectiveness of the community-designed,     family-based dietary and physical activity behavioral intervention on decreasing breast     density   "
87226|NCT02144363|"     Mechanical ventilation used to support the sick newborn infant is associated with many     complications including the development of chronic lung disease. Limiting prolonged invasive     ventilation remains an important strategy to decrease lung injury and prevent chronic lung     disease. Currently, there is no objective measure available to predict readiness for removal     of the endotracheal tube (extubation) and discontinuing mechanical ventilation in this     fragile population.      The investigators propose to predict extubation success by evaluating the electrical activity     of the diaphragm (Edi), which provides important information about the drive to breathing     coming from the brain and the function of the diaphragm, two essential factors determining     extubation readiness and success.   "
87211|NCT02144558|"     Spinal cord injured (SCI) men, para or tetraplegic, most often have an infertility, caused     among others by a deficiency of sperm quality particularly motility and vitality. Several     mechanisms have been proposed: low frequency of ejaculation, recurrent urinary tract and     seminal infections, presence of an inflammatory syndrome (IS) and an oxidative stress (OS).     However, no French study of sperm quality has been conducted in this population that could     identify aggravating factors of sperm quality and a way to prevent them.      Hypothesis: Sperm parameters decrease rapidly following spinal cord injury and next     stabilise. However, unidentified yet risk factors could influence long-term evolution of     sperm parameters.      The objective is to study the evolution of sperm parameters during 18 months taking into     account bladder management, recurrent urinary tract and bladder infections, IS and OS. The     evaluation of these parameters and their consequences will be indicative to determine one or     more risk factors of sperm degradation and determine a strategy for long term support to     avoid the use of ART either by sperm cryopreservation and/or by preventing risk factors   "
88695|NCT02125136|"     The aim ot the study is to investigate the efficacy and safety of two new intensified     chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant     chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and     consecutive conversion of the tumor to resectability.   "
87212|NCT02144545|"     Morbid Obesity (MO) is considered the most important epidemic in the developed world in the     twenty-first century. After initial assessment of morbidly obese patients and the exclusion     of potentially correctable causes, management involves a combination of dietary changes,     cognitive therapy, physical activity, psychological support and pharmacological treatment.     However, any combination of these factors has proven long-term effectiveness in achieving     significant and sustained reduction of excess weight. Currently, surgery is the only     treatment capable of achieving this goal, interacting also with significant improvement in     quality of life and overall long-term mortality.      In recent years, several authors have reported excellent short-term results with performing     sleeve gastrectomy, but whether some aspects regarding the variability of gastric     tubulization design could influence the results obtained in relation to weight loss and     functional changes and gastric hormones.      The main objective of this study is to assess the size of the gastric tubulization (based     probe calibration and the distance from the pylorus to which initiate gastric section) that     can provide a better clinical outcome (such as excess weight loss) in patients undergoing     surgery for morbid obesity. Secondary objectives were to assess the morphological changes,     physiological and hormonal obtained according to the size of the gastric tubulization and its     effect on weight loss patients.   "
87213|NCT02144532|"     The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the     connective tissue. This syndrome has different forms. Hypermobility type is the most common.     It is characterized by generalized joint hypermobility, associated with a chronic pain     syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived     and the most crippling.      Faced with insufficient effect of drug treatment, other alternatives have been proposed to     relieve these patients. Compression garments have been developed. They appear as medical     devices targeted specifically for patients with hypermobility EDS type: in the symptomatic     treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle     globulization, and in the functional improvement.      The VETCOSED study is a quasi-experimental study of type Before / After, monocentric, open.     The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix     Rouge Française de Lyon, in association with the Pôle Information Médicale Evaluation     Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with EDS     hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will wear a     compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks during which     they do not carry this garment.      The main objective is to demonstrate the effectiveness of compression garments in the EDS     hypermobility type, especially in terms of symptomatic improvement joint pain.      The main outcomes expected of this study are:        -  an improvement of the power and the peaks of couple of muscles rotators of shoulders.        -  a decrease of the pains and the defects of articular stability of the shoulder        -  an improvement of the quality of life and the functional independence of these patients   "
87214|NCT02144519|"     The investigators long-term goal is to advance the adoption and successful implementation of     policies that promote PA and nutrition in after school programs (ASP) nationwide. The     investigators objective here is two fold. First, the investigators will test the     effectiveness of two promising strategies designed to 1) increase the amount of PA children     accumulate while attending an ASP and 2) promote changes in the nutritional quality of the     snacks served. This represents a fundamental step in establishing practice-based guidelines     (best practices) for the uptake and achievement of public health policy goals (CA and     Harvard). Second, the investigators will examine the barriers and facilitators to     implementing these strategies. The expected outcome of this study is evidence supporting best     practices for ASPs to employ to meet policy goals.   "
87215|NCT02144506|"     The aim of the pilot-study is to evaluate the feasability of a future RCT, regarding     recruitement of eligible participants, adhesion rate, datarecording and cost. In this     feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to one     of two interventions. The control group gets a well-known home-based exercise program (OTAGO)     aiming to prevent falls where the exercises are prescribed by a physical therapists. The     exercises will be presented on a booklet and on printed cards. The Intervention group     consists of an exercise program, the T&E program, where the elderly persons can choose the     exercises depending on their abilities. The exercises in the T&E program will be presented     in a printed manual and shown on videos on an electronic tablet. Both intervention groups     receive 6 hours of instruction and control/supervision sessions by physical therapists. In     addition, the participants will exercise alone.      The interventions will be performed over 24 weeks.      In this pilot study, the hypothesis is that the adhesion rate is at least 65%. Other     feasibility criteria will be costs, data recording issues and the qualitative evaluation of     the booklet and the tablet.      Falls will be assessed with a falls calendar. The amount of physical activity of the     participants is assessed with an accelerometers (actigraph) and quality of life will be     assessed with OPQOL-35 at baseline, week 16 and week 24.   "
87216|NCT02144493|"     Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis.     However, the exact pathophysiology or mechanism of recurrent cholangitis has not been     established. Periampullary diverticulum and narrow angle of common bile duct have been     postulated as risk factors of recurrent common bile duct stone. The aim of this study was to     evaluate the association between periampullary dierticulum, angle of common bile duct and     recurrent common bile duct stone.   "
87227|NCT02144350|"     The investigators aim to prospectively study the feasibility and clinical impact of     hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares     as an adjunct to standard medical treatment. Specifically, we will investigate the impact of     hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory     markers. The investigators expect that hyperbaric oxygen therapy will improve patient     responsiveness to steroids and avoid progression to second line therapy during     hospitalization.   "
87231|NCT02144298|"     The aim of this study is to observe the perioperative course of sublingual microcirculatory     alterations in patients undergoing coronary artery bypass grafting (CABG) using cold blood     compared with cristalloid cardioplegia. Additionally the impact of changes in hemodynamic     parameters, blood gas, laboratory findings and standart therapy for intra and early     postoperative period was studied. Intubation time, ICU stay, hospital stay, ICU readmission,     morbidity and mortality were recorded.   "
87333|NCT02142972|"     The aims of this study are to investigate whether pelvic pain and low back pain disability     are associated with postpartum depression and to compare the prevalence between women without     Low back pain and disability and women with Low Back Pain (LBP) and disability every     trimester, and correlate postpartum Depression and some clinical and biopsychosocial     variables: subgroups of LBP, disability, pain intensity, pain widespread and nationality, in     a cohort of Spanish women at 2 months postpartum.   "
87217|NCT02144480|"     Although the benefit of cardiac rehabilitation following coronary artery bypass graft (CABG)     is well-established, it is underused. The current investigation will adopt an early,     intensive, short-term and supervised aerobic training at moderate-intensity. The inclusion     criteria are diagnosed coronary artery disease (CAD) and clinical indication for elective     first-time CABG.      Regular physical exercise is associated with overall reduced risk of primary cardiac arrest.     Previous study demonstrated that moderate-intensity exercise training reduced resting and     strenuous exercise-induced activation of platelet and possibly coagulation. Our main research     question is that whether the short-term CR program in the present investigation will     ameliorate hemostatic imbalance at rest and platelet coagulation activation at maximal stress     exercise.      This is designed to be a prospective randomized controlled study. Sixty men who are scheduled     to receive elective CABG in Chang Gung Memorial Hospital at Linkuo will be enrolled in the     study. They will be randomized into two groups: intensive training (IT) and usual     rehabilitation (UR). Participants in the IT group will receive intensive aerobic training at     moderate intensity after CABG. A submaximal exercise test will be performed for intensity     prescription. They will receive two training sessions per day and at least 20 sessions in     total. The CR group will receive usual CR program. After intervention, each participant will     receive a maximal exercise test. Additionally, six-minute walk test, generic and     disease-specific quality of life, will be collected before and after training. Additional 20     age-matched non-sedentary and healthy men without training will be recruited as control     group.      Venous blood will be sampled three times (before and after rehabilitation and maximal stress     test) for the assessment of platelet activation by flow cytometer and activity of coagulation     factors. Mean platelet volume, and platelet activation markers (platelet-bound CD62P%G,     CD63%G, CD40L%G) will be analyzed. Various coagulation and fibrinolysis factors will be     quantified.      We hypothesized that this training program will ameliorate the prothrombotic state and     attenuate platelet reactivity and coagulation induced by strenuous exercise in patients after     CABG. Hopefully, this clinical investigation will establish an early short-term     rehabilitation model following CABG and its efficacy for clinical use.   "
87218|NCT02144467|"     Aim to establish a large-sample database of Multiple-MRI/Gene/Cognition for healthy Chinese     (sample number, 5000; age, 6-70 years). This is a fundamental but very necessary work for     future researches such as development, aging, relation of gene and behavior, relation of gene     and neuroimaging, relation of behavior and neuroimaging. Importantly, this work will provide     a norm for researches on psychological or neurological patients. This large-sample will be     shared with world-wide researchers.   "
87219|NCT02144454|"     Cardiovascular disease (CVD) is the leading cause of death in women. Premenopausal women have     a lower risk of CVD compared with men of a similar age. However, the incidence of CVD     increases greatly after the menopause. The risk of heart disease is strongly associated with     the health of an individual's blood vessels. It is thought that changes to the type of fat     the investigators eat in their diet may affect the normal functioning and elasticity of the     blood vessels, as well as affect cholesterol levels in the blood. Types of fat in the diet     include monounsaturated fats (found mainly in olive oil), n-6 polyunsaturated fats (found     mainly in sunflower oil) and saturated fats (found mainly in dairy products, such as butter     and cheese). Since the investigators are in the fed (or postprandial) state for up to 18     hours of the day, it is important to see how these different fats affect the investigators     blood vessels and blood fats over the course of the day after eating a meal. The aim of this     study is to determine how consuming meals rich in saturated fats, n-6 polyunsaturated fats or     monounsaturated fats influence the normal functioning and elasticity of the blood vessels     throughout the day in postmenopausal women. A secondary aim is to determine the effects of     these different dietary fats on a range of accepted heart disease risk markers including     circulating levels of fats (lipids) and glucose in the blood.   "
87220|NCT02144441|"     This study will examine the feasibility of implementing a clinician-supported patient     self-managed inpatient insulin intervention. It will: assess the number of eligible patients     presenting over time; assess patients' willingness to enroll; assess patients' ability to     successfully complete the intervention; examine occurrences of hyperglycemia and     hypoglycemia; and assess patients' satisfaction with inpatient diabetes care.   "
87221|NCT02144428|"     The management of children with confirmed cow's milk allergy is based on complete avoidance     of cow's milk proteins and leaves the physician with several dietary options, none of which,     given the prevalence, spectrum and potential seriousness of the condition, can be recommended     to all patients. In the absence of an alternative to cow's milk, the management of cow's milk     allergy is based on the use of safe, affordable and nutritionally adequate formulas.     Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most     children with cow's milk allergy, are still liable to contain residual peptides, and     hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus,     specific product allergenicity must be addressed on an individual basis before recommending a     formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize     cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety     and nutritional efficacy perspectives. These formulas have been proposed for subjects highly     sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed     formula and for children with multiple food allergies. In these conditions aminoacid based     formulas are able to effectively cure allergic symptoms and to improve body growth.   "
87222|NCT02144415|"     This single-center study will be a single-dose, randomized, double-blind, placebo- and     active-controlled crossover study with a single inpatient treatment visit. The abuse     potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of     placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant     users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient     Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety     Follow-up visit (Visit 4).   "
87223|NCT02144402|"     The primary objective is to determine if the weight gain of healthy term infants fed a     commercially available term infant formula supplemented with DHASCO® is similar to that of     infants fed the same formula supplemented with a new product, DHASCO®-B.   "
87224|NCT02144389|"     Randomized Controlled Trial:      The investigational materials used in this trial were administered to subjects each day by     trained clinicians.      Primary Objectives:        -  assess the effect of dietary supplementation with arachidonic acid on the cure rates for          Schistosomiasis mansoni with and without concomitant treatment with praziquantel.        -  assess the safety of dietary supplementation using arachidonic acid in children with          clinically confirmed schistosomiasis mansoni infection.      Secondary objective:        -  to measure changes in total phospholipids in plasma.   "
87225|NCT02144376|"     The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure     whole gut transit time in people with constipation, and how readily it can detect a change in     transit time induced by taking a dietary supplement with laxative effects.The investigators     expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the     intestinal tract.      The investigators will also assess whether a change in gut bacteria and the chemicals that     they release can be detected.   "
87232|NCT02144285|"     The purpose of this study is to look at the tolerability and safety of LY3113593. Study     doctors will see how safe it is and whether it produces side effects following a single     injection into a vein or under the skin in healthy participants (Part A) and participants     with chronic kidney disease treated with hemodialysis (Part B). The study will also measure     how much of the study drug gets into the blood stream, how long it takes the body to get rid     of the study drug and what effects the study drug has on the body.      This is the first time that this study drug is being given to participants. This study is for     research purposes only and is not intended to treat any medical condition. For each     participant, the study will last about 85 days, not including screening. Screening is     required within 28 days prior to the start of the study.   "
87233|NCT02144272|"     The main purpose of this study is to learn more about the safety of LY3114062 and to find out     how well it is tolerated in participants with an inflammatory arthritis. The study will also     investigate how the body processes the drug and how the drug affects inflammatory arthritis.     The study is expected to last about 3 months.   "
87234|NCT02144259|"     This is a prospective mixed methods study to assess weight changes in women randomized to     receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who     choose non-hormonal contraception or no contraception immediately postpartum. After     enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series     of questions, take a pregnancy test, and be weighed. Total length of participation for each     subject is 1 year or until pregnancy.   "
87235|NCT02144246|"     Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal     contraception in this sample of women and to evaluate the impact that this hormonal     contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles     accompanied by cyclic exacerbations.      We hypothesize:      1a) women with CF who perceive an overall benefit of hormonal contraception will be more     satisfied than women with CF who do not perceive a benefit,      1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa     mucoidy conversion while using hormonal contraception,      1c) women with CF who have cyclic exacerbations will have improved patient-reported quality     of life indices while on hormonal contraception, and      1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function     tests while on hormonal contraception.      Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at     the time of ovulation and compare it to that of healthy controls.      We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.   "
87236|NCT02144233|"     The primary endpoint will be the average change in pain score from baseline to the three- and     six-month assessments. Efficacy will be demonstrated by superior pain relief with the active     treatment compared with the placebo.   "
87237|NCT02144220|"     The primary objective of this study is to evaluate the feasibility, efficacy and the value of     providing care to individuals with Parkinson disease directly into their homes. The specific     aims are:        1. To demonstrate the feasibility of conducting remote evaluations of patients with          Parkinson disease nationally;        2. To measure the impact of remote care on each patient's ability to improve his or her          quality of life (QoL) and better manage his or her Parkinson disease; and        3. To assess the long-term acceptability to patients in receiving ongoing care remotely via          telemedicine.   "
87238|NCT02144207|"     Some surgical procedures require general anesthesia (i.e., the patient is 'asleep'). When     under general anesthesia, these patients' airways must be managed to ensure continuous flow     of oxygen to the lungs, and in most cases, delivery of anesthetic gases to the lungs. Most     often for airway management under general anesthesia, a plastic breathing tube is placed     though the voicebox (larynx) into the windpipe (trachea), a process known as tracheal     intubation. To safely intubate, the larynx must first be exposed. In many cases, this is     achieved by using a device known as a direct laryngoscope, which is like a curved, lighted     tongue depressor. It is used to gently move the tongue out of the way, to expose the larynx.     When the larynx is easily seen, passing the breathing tube is usually also easy.     Unfortunately, in 2-5% of cases, it is difficult or impossible to view the larynx using the     direct laryngoscope. This then creates difficulty with tube passage. A number of options     exist to deal with this situation, including, within the last 10 years, a class of device     called video laryngoscopes. These devices use a small video chip located towards the end of     the blade, which, by providing transmission of an image of the larynx 'around the corner' to     a screen outside the patient, enable a view to be obtained (when no such view could be     obtained with direct laryngoscope). With the larynx now indirectly visualized, tube passage     can proceed. However, it's not that easy. When using these 'around the corner'     videolaryngoscopes, tube passage can be more difficult, as the tube must be guided around a     90 degree bend from the mouth to the trachea, which sits at right angles to the mouth. Less     difficulty occurs with tube passage when the direct laryngoscope is used because the blade     compresses the tongue out of the way, creating a straight line from teeth to the larynx and     windpipe beyond.      The GlideScope is one example of video laryngoscope, and has been in use here at CDHA for 10     years. It has been extensively studied over the ten years, with more than 300 studies     appearing in the literature. The investigators know from these studies that it is very     effective at delivering a view of the larynx when direct laryngoscopy has failed to do so.     However, getting the tube to and through the larynx into the trachea, even with a good view,     can be problematic. Furthermore, it is the impression of some clinicians that when a     close-up, full view of the larynx is obtained (as is optimal for direct laryngoscopy) with     the GlideScope, tube passage appears to be a little more difficult than seems to be the case     when only a partial view of the larynx is obtained, from a little further away. The     investigators don't know why this may be so, but may relate to one or more of a number of     reasons, including (when too close) angling the larynx into an unfavorable angle, or (when     further away) more favorably reducing the angle between mouth and larynx and trachea.     However, no guidance on this question appears in the peer-reviewed medical literature, and no     studies have been done. There is some suggestion in non peer-reviewed internet sites on     airway management that a partial view may be better, but again, this has not been     scientifically studied or validated one way or another.      As mentioned, the GlideScope has been in regular use in CDHA for many years. Most often, it     is used when difficulty with tracheal intubation is anticipated or has already been     encountered in the anesthetized patient, although some airway experts suggest that within the     near future, all intubations will occur with some sort of video laryngoscope.      It is important to research the present question as in contemporary practice many     anesthesiologists, faced with a patient in whom they are anticipating difficult direct     laryngoscopy proceed with putting the patient to sleep, relying on the video laryngoscope to     enable them to intubate. With a patient now anesthetized and not breathing, if they then have     trouble intubating the patient in spite of getting a view of the larynx, harm could occur to     the patient from a failed intubation situation. Furthermore, there are now a number of     studies documenting that patient morbidity can increase with multiple intubation attempts.   "
87239|NCT02144194|"     This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel     combination given as an initial upfront treatment (first line) to all metastatic breast     cancer patients enrolled. Patients having a disease control following initial treatment, will     be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will     also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.   "
87240|NCT02144181|"     This is a prospective, multi-site (up to 5 sites), single-blinded, randomized trial. Up to 88     subjects will be enrolled and randomized to one of four treatment groups (4 Groups of 22     subjects), and will receive study treatments based on their assigned treatment group.     Following study treatments, follow-up visits will occur at 90, 180 and 365 days from each     subject's last study treatment.   "
87241|NCT02144168|"     Primary objective of this study is to measure the change of concentration of faecal     bifidobacteria between critically ill patients who receive enteral formula with and without     prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in the     concentration of faecal bifidobacteria between critically ill patients who receive enteral     formula with and without prebiotics during enteral nutrition (EN). Three faecal samples will     be taken from the patient. First faecal sample is the first stool after initiation of EN and     second sample is taken seven days after the initial sample and the third faecal sample is     taken at day 14 after initial sample. Patient will be randomized to receive either of     described formula after baseline (first) stool sample is obtained. Patient will be monitored     up to 14 days after the initial stool sample is obtained.   "
87242|NCT02144155|"     The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin     in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute     being on adequate treatment with antipsychotic medication.   "
87265|NCT02143856|"     The purpose of the study is to evaluate the amount of compound present in the blood (relative     bioavailability) after a single oral administration of GLPG1205 given as a capsule     formulation in fasted versus fed conditions in male healthy subjects.      Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule     formulation under fasted and fed conditions will be assessed.   "
87266|NCT02143843|"     The purpose of this study is to evaluate safety and comfort of the ForSight VISION5 product     when used for up to 13 months.   "
87267|NCT02143830|"     The purpose of this study is to determine whether the use of lower doses of busulfan and the     elimination of cyclosporine will further reduce transplant-related side effects for patients     with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or     matched unrelated donors following a preparative regimen of busulfan, fludarabine,     anti-thymocyte globulin and cyclophosphamide.   "
88696|NCT02125123|"     This study will investigate the effect of an oral nutritional supplement (ONS) along with     dietary counseling on improving the dietary intake among children with picky eating     behaviors.   "
87243|NCT02144142|"     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of     S. aureus skin infections. In addition, research in the investigator's lab has shown that     these patients have fewer protective Staphylococcal species such as Staphylococcus     epidermidis (S. epidermidis) that are known to produce antimicrobial peptides that play a     role in protecting the skin from invading pathogens. In this study, the study team will     attempt to decrease S. aureus colonization and increase colonization by protective Staph     species in AD patients by first culturing the bacteria on subjects' lesional AD skin. The     study team will selectively grow the subject's protective Staph colonies and place them into     a moisturizer. The first part of the study will determine the half-life of the     bacteria-containing moisturizer. The bacteria-containing moisturizer will be applied to a     subject's arm, and the subject will return at four different time points over the next three     days for skin swabs of the arm that will be used to determine the amount and type of bacteria     on the arm at those time points. In the second part of the study, the subject will apply     moisturizer containing his own antimicrobial bacteria to one of his arms for a total of 6     times at a frequency determined by the half-life, which will be computed at the end of the     first part of this experiment. The subject will return prior to the 7th application time     point for skin swabs of the arm to ensure that there are still viable bacteria from the     moisturizer present on the arm. In the third part of the study, each subject will receive     both moisturizer as well as moisturizer plus his own antimicrobial bacteria. The subject will     apply the moisturizer to one arm and the moisturizer plus bacteria to the other arm daily for     a total of 15 days. Subjects will return to the clinic every 5 days for skin swabs and     clinical evaluations. If the moisturizer containing bacteria is able to decrease the S.     aureus colonization on subject's arms, the study team hypothesizes that subjects will have     improvement of their AD symptoms.   "
87244|NCT02144129|"     The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated     passive in a supine resting position or active during slight movements compared with a     non-training control group on body composition, muscle strength and QoL in patients with     ulcerative colitis.      Our main hypothesis is that active WB-EMS application is significantly more favorable to     address our primary endpoints compared with passive application.      Our secondary hypothesis is that passive WB-EMS application is significantly more favorable     to address our primary endpoints compared with non-training control.   "
87245|NCT02144116|"     Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with     generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms     like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological     disorders. This condition is very prevalent. It has been reported to be about 2-5% of the     general global population. Fibromyalgia is associated with balance problems and increased     fall frequency. The objective of this study was to examine the effects of an 8 weeks     dance-movement therapy programme on balance, strength, flexibility and quality of life in     patients with fibromyalgia.   "
87246|NCT02144103|"     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front     abdominal wall. ADRC will be administered one-time into subtenon space of patient's eyeball.     This is a single arm study with no control. All patients receive cell therapy.   "
87247|NCT02144090|"     The purpose of this study is to assess the usability and safety of the Opsens OptoWire and     Optomonitor in measuring fractional flow reserve (FFR) in patients with coronary artery     disease who are undergoing a coronary angiogram.   "
87248|NCT02144077|"     The aim of this study is to test the effectiveness and safety of the medicine Ameluz®, used     with photodynamic therapy (PDT), to treat thin, non-aggressive rodent ulcer.   "
87249|NCT02144064|"     Objective To determine maternal and fetal outcomes in women with Unexplained RPL managed with     aspirin or unfractionated heparin (UFH) plus aspirin during pregnancy.      Design: prospective clinical controlled study. Setting: high-risk pregnancy unit- Benha     university hospital. Methods: Pregnant women with unexplained recurrent miscarriage attending     high-risk pregnancy unit. 200 selected patients with previous unexplained recurrent     miscarriage are divided into 2 groups: group A (n = 100) receive low-dose aspirin (81 mg once     daily orally) plus heparin (5000 IU) every 12 h with the ﬁrst positive pregnancy test while     group B (n = 100) receive no thing .      Main outcome measures: Maternal outcomes included thromboembolic and haemorrhagic     complications and pregnancy-induced hypertension .Prematurity, intrauterine growth     restriction and neonatal death were considered as maternal and fetal complications   "
87250|NCT02144051|"     This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose,     Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a     multicentre study with sites in the United States and United Kingdom. Approximately 90     patients are expected to be enrolled in this study.      The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.   "
87251|NCT02144038|"     This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate     the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when     administered orally to adult patients with relapsed and refractory multiple myeloma. Once the     MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients     will be enrolled in the Phase II part to determine whether the combination of LGH447 and     BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447.   "
87252|NCT02144025|"     Ocular Graft Versus Host Disease (OGVHD) is a serious potential complication of allogeneic     bone marrow transplants. The usual treatment is topical cyclosporine but when the treatment     is initiated the damage to the lacrimal glands has already taken place.      The present study aims to prevent OGVHD in reduced-intensity allogeneic hematopoietic     transplants by using topical cyclosporine immediately after the engraftment has been achieved   "
87253|NCT02144012|"     This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical     trial to investigate a first-line treatment of participants with human epidermal growth     factor receptor-2 (HER2)-positive metastatic breast cancer. The study will enroll patients     with HER2-positive, unresectable, locally advanced breast cancer (BC) if they have recurrent     disease or progressive disease (PD) despite primary multi-modality therapy, and/or metastatic     BC if they have not received prior chemotherapy for their metastatic disease. Eligible     participants at up to approximately 40 sites in the Asia-Pacific region will be randomized in     a 2:1 ratio to receive trastuzumab emtansine (Arm A) or trastuzumab plus docetaxel (Arm B).     All study drugs will be administered at in-clinic visits occurring every three weeks during     the treatment phase. Trastuzumab plus docetaxel was chosen as the comparator in the control     group (Arm B), as it represents a common first-line treatment option used in this patient     population in China and other Asia-Pacific countries.   "
87254|NCT02143999|"     This observational study will evaluate the effectiveness of BRAF inhibitors and current     therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600     mutation. Patients will be treated per the locally approved therapeutic options in clinical     practice. The observation period for each patient will be up to 24 months.   "
87255|NCT02143986|"     In healthy subjects, from 50 to 80 % of the serum ferritin is glycosylated [1, 2] . A     decrease in the percentage of ferritin glycosylation can be observed in inflammatory     diseases, malignancies, infections, or liver disease but is rarely less than 20% [3 , 4] .     Percentage of glycosylated ferritin below 20% have been described in patients with adult     Still's disease and haemophagocytosis lymphohistiocytic syndromes (HLH).      The glycosylated ferritin has been included in the diagnostic criteria for Still's disease in     adults. A cut-off of less than 20 % has a sensitivity and specificity of 72 and 69 %     respectively , and 35 and 94 % when combined with a total ferritin level greater than 5 times     normal value. This parameter was also suggested to be a more specific marker to confirm a     diagnosis of HLH than a high ferritin level ( > 500μg / L). However, several limitations of     this parameter were highlighted, some conditions making its interpretation difficult :     particularly in cases of major hepatic cytolysis and severe sepsis (miliary tuberculosis,     lymphoma and disease Adult Still).      It is not always possible to distinguish severe sepsis, HLH syndrome and Still's disease.      A fine analysis of various glycoforms components of ferritin could be used to distinguish     different subgroups of patients. Few data are available on the mechanism of secretion and     glycosylation of ferritin, but the investigators assume that the glycosylation patterns of     ferritin may vary between different disease states and reflect distinct underlying     pathophysiological mechanisms.   "
87256|NCT02143973|"     The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER     tablets during a treatment period of up to 24 weeks.   "
87257|NCT02143960|"     The purpose of this study is to compare the clinical performance of the VelaShape III device     with CoolSculpt for reduction of the waist, love handles and flanks.   "
87258|NCT02143947|"     The purpose of this study was to determine the effectiveness of two types of in-shoe custom     made orthotics in altering the motion of the foot and muscle activity of select muscles of     the lower leg in individuals experiencing lower extremity symptoms of a non traumatic origin.     We hypothesized that orthotics would decrease the extent of motion of the during walking and     running when compared to a barefoot condition. The investigators further hypothesized that     orthotics would decrease the amount of muscle activity seen during walking and running when     compared to barefoot walking.   "
87259|NCT02143934|"     This study specifically seeks to quantify the contribution of relapes to the burden of P.     vivax infections and disease by determining on the effect of radical pre-erythrocytic and     erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in     children aged 5-10 years in a treatment to re-infection study design. In order the clear     liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days,     standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days,     0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.      In addition to this epidemiological data, the study will assess the natural acquisition of     cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the     determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG     children aged 5-10 years.      These data will not only be essential for development of future vaccines against P. vivax and     P falciparum but provide invaluable insight into the contribution of long-lasting     liver-stages to the force of infection with P. vivax that will contribute towards designing     more rational approaches to the treatment of P. vivax both in the context of case management     and future attempts at elimination.   "
87260|NCT02143921|"     Alternative, sustainable interventions in support of zinc treatment for childhood diarrhea     need to be identified. Within the NGO sector, direct provision of health services is     provided, however some NGOs also work closely with the private sector providers.     Hypothetically, this avoids unnecessary duplication of effort and enhances the quality of the     care provided in the private sector. This study will provide objective evidence of the impact     of this approach, using the scale-up of zinc for the treatment of childhood diarrhoea as a     test case. The study will be assessing NGO impact among unregulated (unlicensed), rural     service providers. Further, this study will serve to assess the value of this model of     scaling up activities in the non-state sector with a particular eye toward more generalizable     and replicable improvement in quality of care strategies between NGOs and unlicensed private     providers. This will be controlled before-after (CBA) study. An equivalent control area will     be included in the study. The objective is to document changes in zinc and antibiotic as well     as anti-diarrhoeal usage in childhood diarrhea following a scale-up intervention package     delivered by a local NGO to local private providers. This will include sensitization,     training and follow-up support. Impact will be assessed in terms of changes in zinc coverage     and antibiotic use among households in the catchment population served by these providers.     The study will be conducted in four unions located in Sreepur Upazila within Gazipur     district, located north to Dhaka. Two of the unions, namely Rajabari and Prohladpur     comprising 55 villages with 15,530 households and an estimated 76,150 population will serve     as intervention area. The other two unions Telihat and Barmi will be taken as control sites.     They contain 53 villages with 19,898 households and an estimated 99,000 population. The     curative health services in these sites are provided by local drug vendors, village     practitioners, traditional healers, and licensed government, private or NGO health service     providers. Data will be collected through survey and in-depth interviews. Data will be     entered and analyzed using SPSS version 12.0. Absolute counts, proportions, and means with     95% confidence interval will be calculated. These and regression analysis will be done using     STATA version 9, cluster survey program, that accounts for potential within cluster     homogeneity. Based upon the household surveys, the outcomes that will be calculated are:     coverage-the proportion receiving zinc, ORS (zinc and ORS), and antibiotics or     antidiarrhoeals and changes in coverage 6 months following the introduction of the     intervention package, equity: who is receiving zinc by age, gender and socioeconomic status.     For differences in categorical outcomes crude relative risks and 95% confidence intervals     will be determined. It is expected that the study will help in increasing zinc coverage for     the treatment of children under five years of age and decrease in the use of antibiotics and     antidiarrhoeals within the NGO catchment population.   "
87261|NCT02143908|"     Diarrhea as of today is still a major problem in developing world with high morbidity. Though     mortality in under-5 children has declined over the years, diarrhea was responsible for 2.5     million deaths per year in developing countries. A median of 3.2 episodes of diarrhea in     under-5 children per child-year has been estimated in developing countries. In Bangladesh,     the overall prevalence of diarrhea was estimated to be about 2% for the entire population.     However, a recent survey in 2003 with urban slum mothers indicated that the prevalence of     diarrhea ranged from 0.7-4.1% in six divisional cities with 0.7% in Dhaka slum areas.     Malnutrition remains the major adverse prognostic indicator for diarrhea related morbidity,     which emphasizes importance of nutrition in early management. Repeated episodes of diarrhea     are a frequent cause and consequence of malnutrition. To improve diarrhea situation in     Bangladesh and elsewhere, interventions are directed to reduce mortality and morbidity     through improvement of breast-feeding practices, complementary feeding, sanitation, increase     in measles immunization rates, micronutrient supplementation, and oral rehydration therapy.      L-lysine, an essential amino acid, is required for healthy growth, tissue repair and enzyme     production. It is a protein-building block that strengthens and nourishes the structural,     circulatory and immune systems. It is not produced by the body like other essential amino     acids and must be obtained from the diet. Some natural food sources for L-lysine include Lima     beans, kidney beans, potatoes, corn, red meat, fish and milk. The mean requirement of lysine     in healthy human adults is about 30 mg/kg body weight/day or 50 mg/g protein intake. Studies     have shown that lysine therapy improves immune status and is used as a therapeutic agent in     herpes simplex viral infection. A double-blind randomized trial of L-lysine treatment found     it to be an effective agent for significant reduction in occurrence, severity and healing     time for recurrent herpes simplex viral infection. Lysine fortification increased the blood     levels of complement 3 (C3), CD-4 and CD-8 T-cells as compared with controls. These two     studies suggest that supplementation of lysine through food fortification enhances     immunological status. A few recent studies have also shown an effect of lysine on diarrheal     incidence and severity. An experimental model suggested inhibitory effect of L-lysine on     incidence of diarrhea induced by stress and 5-hydroxytryptamine. A community trial among     adults in Syria showed that the period prevalence and mean duration of diarrheal illness were     significantly lower in the female participants who consumed lysine-fortified wheat bread     compared to the control group as well as better immunological parameters such as C3c delta.      The proposed study will observe the impact of a daily dose of 2000 mg supplemental L-lysine     for 6 months on diarrheal illness in an adult population of an urban slum area in Dhaka whose     principal diet is based on cereals such as rice and or wheat. The daily protein and lysine     availability from diets of Bangladeshi population has been calculated to be about 43g and     1883 mg respectively, compared to 113g and 7,598 mg respectively in the USA. This means that     2000 mg daily supplementation of L-lysine would not pose any detrimental effect, as the     combined usual and supplemental intake will still be substantially lower compared to the     intake in USA. However, as expected, the supplemental L-lysine may reduce the incidence and     severity of diarrheal illness through improvement of the nutritional and immunological status     of the study population.      The investigators propose to conduct a community-based, double-blind randomized controlled     trial in Mirpur area of Dhaka city. Adults aged 18 to 45 years residing in the catchment area     for at least the last six months will be eligible for the study. A total of 440 subjects (220     females) will be enrolled. The results of the proposed study will contribute to our existing     knowledge of the effect of lysine on incidence and severity of diarrheal illness as well as     on immune status. A positive impact of lysine supplementation on diarrheal illness may lead     to a future strategic approach to the control of diarrhea as a global public health problem.   "
87262|NCT02143895|"     Evaluation of the effects of etifoxine versus a benzodiazepine (lorazepam) on vigilance and     cognitive functions in the elderly.   "
87263|NCT02143882|"     The Department of Health has recently announced the implementation of annual vaccination for     all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is     delivered as a nasal spray. This study seeks primarily to measure antibody responses to the     LAIV vaccination over three subsequent years and will involve six blood samples, six dried     blood spots (taken from the end of the blood sample needle) and six oral fluid samples -     before and three weeks after each vaccination each year. These samples will allow us to     assess how the immune system responds to the vaccinations in terms of the antibodies that are     present.   "
87264|NCT02143869|"     Denutrition and Obesity are risk factors for perioperative surgical complications.      In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of     cancer induces a high intensity cellular stress response and catabolism reinforcing the risk     for perioperative denutrition.      In this study, we thought to investigate the change in body composition during the     perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis     (BIA).   "
87268|NCT02143817|"     Arterial dysfunction contributes to the development of cardiovascular disease (CVD), which is     currently afflicting millions of individuals. The use of the amino acid L-citrulline has been     suggested as a potential aid for the treatment of CVD by increasing endothelial production of     Nitric Oxide (NO). Whole body vibration (WBV) is new and effective form of exercise that is     feasible for clinical populations and has been proven to decrease blood pressure (BP) and     arterial stiffness and increase muscle mass and strength. Therefore, the purpose of this     study was to investigate if the combination of WBV training (WBVT) plus L-citrulline     supplementation would induce positive additive effects and would be an effective means to     ameliorate arterial stiffness, endothelial function, BP and muscle strength/mass in     postmenopausal women.   "
87269|NCT02143804|"     This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis     with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT     01438112), or in high grade Ta and T1 patients who failed BCG therapy.   "
87270|NCT02143791|"     The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM     neuromodulation system in the management of failed back surgery syndrome or chronic     intractable pain of the trunk and/or limbs.   "
87271|NCT02143778|"     This study will be used to train an algorithm using Methacetin breath test (MBT) measures and     to select a cut-off to determine presence or absence of Clinically Significant Portal     Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg   "
87272|NCT02143765|"     Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K     (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the     channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide     and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial     hyperglycemia and improves overall glycemic control.      This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The     purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in     patients with type 2 diabetes mellitus.   "
87273|NCT02143752|"     The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation     Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking     Cessation Program. The Meriter Smoking Cessation Program has two interventions, the     Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention.     Study activities include one 10-minute study visit and two 5-minute survey phone calls.   "
87274|NCT02143739|"     The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma     patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).   "
87275|NCT02143726|"     This randomized phase II trial studies the effects, good and bad, of using everolimus along     with sorafenib tosylate versus sorafenib tosylate alone in treating patients with advanced     radioactive iodine refractory thyroid cancer. Sorafenib tosylate and everolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of     everolimus to sorafenib tosylate may cause more shrinkage of thyroid cancer and may prevent     it from growing but it could also cause more side effects than sorafenib tosylate alone. It     is not yet known whether this treatment with sorafenib tosylate and everolimus is better, the     same, or worse than sorafenib tosylate alone.   "
87276|NCT02143713|"     A randomized study evaluating the continued safety and efficacy of elagolix in the management     of moderate to severe endometriosis associated pain in adult pre-menopausal female subjects     who completed 6 months treatment in Study M12-671.   "
87277|NCT02143700|"     Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment     in functionality and in the execution of activities of daily life. The hypothesis of this     study is to examine the relationship between cognitive status and clinical profile     (respiratory, sleep quality, nutritional status) in patients with chronic obstructive     pulmonary disease in two different moments: exacerbation or stable situation.   "
87278|NCT02143687|"     The purpose of this study is to investigate the effect of travelling to moderate altitude and     of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of     patients with pulmonary hypertension or with interstitial lung disease.   "
87279|NCT02143674|"     Introduction: The life expectancy and the number of people hitting the old age have increased     in recent years. The aging process is accompanied by morphological and functional changes     that contribute to reduced functional capacity, increase the number of falls and the     appearance of physical limitations. Exercise promotes maintenance of functional autonomy,     improving the physical ability of the elderly making it more independent.      Objective: To evaluate the effect of a program of muscle strengthening exercises associated     with global stretching on balance, fear of falling and functional capacity in elderly women.      Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60     years were divided into two groups: intervention group (IG, n = 7) submitted to muscle     strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group     (CG, n = 5), not submitted to the protocol but were educated about physical exercises. Before     and after the protocol were evaluated scores of Berg Balance Scale, the Falls Efficacy Scale     International (FES-I) and Evaluation of Functional Autonomy Development Group for Latin     American Maturity (GDLAM). Data were statistically analyzed within and between groups with a     significance level of p <0.05.   "
87298|NCT02143427|"     The efficacy of the computer based Treatment Program for Children with Aggressive Behaviour     (Soziales computerunterstütztes Training für Kinder mit aggressivem Verhalten, ScouT) which     is a child focused social competence training delivered in an individual format will be     evaluated in a randomized controlled trial with children aged 6 to 12 years with peer-related     aggressive behaviour.   "
90865|NCT02096744|"     To establish the bioequivalence and adhesion properties of transdermal clonidine prepared     with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with     VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.   "
88560|NCT02126891|"     To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical     exercises in two groups of subjects:        -  Canoeists from a training center of the French canoeing team during an intensive session          of three weeks of endurance training;        -  Young recruits in military school of officers in ground forces of the French army during          an intensive.   "
87280|NCT02143661|"     The purpose of this prospective observational study is to investigate if mechanically     ventilated patients who are treated in one of the new intensive care unit (ICU) rooms have     less delirium compared to patients who are treated in the conventional rooms on the same ICU.     The investigators will further evaluate the impact on sleep quality, circadian rhythm, global     cognitive function and general outcome parameters.      The investigators recorded light and noise conditions in the ICU rooms before start of the     redesigning process (subproject light and noise in the intensive care unit (LiNo-ICU)). The     investigators will compare data regarding light and noise in the ICU rooms before and after     the redesigning process (non-patient related data; ethical vote amendment 08.05.2014).   "
87281|NCT02143648|"     The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER     tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in     hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and     tolerability in the study population.   "
87282|NCT02143635|"     To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected     advanced tumors characterized by wild-type TP53.   "
87283|NCT02143622|"     To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects     in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell     carcinoma.   "
87284|NCT02143609|"     The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a     stay at moderate altitude on exercise performance of patients with chronic obstructive lung     disease.   "
87285|NCT02143596|"     The investigators studied laboratory measurements and previously identified risk factors to     identify factors predictors of early deterioration following stroke. A prospective     observational study of 196 patients with first-time acute ischemic stroke was performed.     Following multivariate analysis, only a Bun/Cr >15 was independent predictor of SIE. These     patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio     indicates relative dehydration of the patients. An immediate intervention for such patients     should be the maintenance of proper hydration.   "
87286|NCT02143583|"     Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50     µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of     allergic rhinoconjunctivitis during the 2nd following birch pollen season.   "
87287|NCT02143570|"     Overactive bladder is a common problem among adult women. Darifenacin is an antimuscarinic     drug that is frequently used as part of the management of the condition. However, current     evidence backing its use is limited. This study aims to address Darifenacin's effectiveness     in adjunct to physiotherapy in treating symptoms due to overactive bladder.   "
87288|NCT02143557|"     Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment     requires discontinuation of breast milk feeding, due to the abundance of long chain     triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective:     To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of     chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was     that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis     compared to infants fed an MCT based formula which is the current standard of care. Design:     Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk     that had been modified by removing the fat layer via centrifugation and adding MCT and     nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8)     received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after     chest tube removal per The Hospital for Sick Children standard chylothorax treatment     protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length     and head circumference measurements and estimated energy and nutrient intake.   "
87289|NCT02143544|"     The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces     clinical complications in high-risk patients undergoing cardiac surgery.   "
87290|NCT02143531|"     This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in     controlling established postoperative nausea and vomiting (PONV) in the first 24 hours     following administration similar to the standard of care ondansetron 4 mg.   "
87291|NCT02143518|"     Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is     thought to play a role in the parasite's degradation of host hemoglobin for use as an energy     source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in     challenge studies. This study will evaluate the safety and immunogenicity of two formulations     of Na-GST-1 in healthy adult volunteers when co-administered with the immunostimulant CpG     10104, a Toll-like Receptor-9 agonist.   "
87292|NCT02143505|"     Calcium plus vitamin D may be effective in the prevention of colorectal adenoma recurrence.     The aim of this study is to investigate the effect of supplementation with calcium plus     vitamin D on the recurrence of colorectal adenomas.   "
87293|NCT02143492|"     Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The     purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor     specimens that would normally be discarded after surgery.   "
87295|NCT02143466|"     The purpose of this study is to determine the safety, tolerability and preliminary     anti-tumour activity of AZD9291 when given together with AZD6094 or selumetinib in patients     with EGFR mutation positive advanced lung cancer.   "
87296|NCT02143453|"     Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise     training mode is still unclear. In this study, the investigators compared the health-related     effects of high intensity interval training versus endurance training in obese children.   "
87297|NCT02143440|"     To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients     who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.   "
91321|NCT02090764|"     This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority     clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical     diagnosis of non-bullous or bullous impetigo.   "
88569|NCT02126774|"     HEP is a five-year, prospective, observational study whose primary goal is to identify     clinical characteristics and biomarkers predictive of disease outcome, progression, and     treatment response in participants with newly treated focal epilepsy.   "
87299|NCT02143414|"     This phase II trial studies the side effects and how well blinatumomab and combination     chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with     acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells     and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate,     methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and     prednisone may kill more cancer cells.   "
87300|NCT02143401|"     This phase I trial studies the side effects and the best dose of navitoclax when given     together with sorafenib tosylate in treating patients with solid tumors that have returned     (relapsed) or do not respond to treatment (refractory). Navitoclax and sorafenib tosylate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
87301|NCT02143388|"     This is an randomized, controlled, multicenter phase II clinical trial. The purpose of this     study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with     or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal     carcinoma.   "
87302|NCT02143375|"     Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and     cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and     noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod     laser on the treatment of PGP in patients.   "
87303|NCT02143362|"     The study designed to explore the efficacy and safety of the closed loop of target controlled     infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.   "
87304|NCT02143349|"     Coleus forskohlii extract contains the bioactive compound, forskolin. Preliminary studies     have shown that forskolin can increase fat metabolism thus reduce fat accumulation in both     animals and humans. It has been suggested that forskolin may also suppress appetite thus     reduce energy intake and results in weight loss. This study will evaluate the appetite     suppressant properties of Coleus forskohlii extract. In addition the effect on central     obesity and risk factors of metabolic syndrome will also be investigated.   "
87305|NCT02143336|"     A comparison of skin closure techniques (standard skin closure with staples versus a     continuous (subcuticular) absorbable suture), to determine if this changes the rate of post     operative wound infections in elective colorectal surgery patients.   "
87306|NCT02143323|"     This study has an open-label, one-sequence, multiple drug administration design. The purpose     of this study is as follows;        -  To evaluate the change of liver function according to glutathione s-transferase (GST)          genotype after the multiple administration of amoxicillin/clavulanate.        -  To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and          microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.   "
87307|NCT02143310|"     Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are     otherwise known as electronic cigarettes devices/systems. These may look like conventional     cigarettes but do not contain tobacco.      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or     glycerol), nicotine, water, and flavours.      This trial is to evaluate the safety and tolerability of an e-vapour product over two years.   "
87308|NCT02143297|"     The sleep apnea hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent     breathing cessations (apneas) or partial collapses (hypopneas) during sleep. These     respiratory events lead to deep oxygen desaturations, blood pressure and heart rate acute     changes, increased sympathetic activity and cortical arousals. The gold standard method for     SAHS diagnosis is in-hospital, technician-attended overnight polysomnography (PSG). However,     this methodology is labor-intensive, expensive and time-consuming, which has led to large     waiting lists, delaying diagnosis and treatment. Blood oxygen saturation (SpO2) from     nocturnal pulse oximetry (NPO) provides relevant information to detect apneas, it can be     easily recorded ambulatory and it is less expensive and highly reliable. The investigators     hypothesize that an automatic analysis of single oximetric recordings at home could provide     essential information on the diagnosis of SAHS. The aim of this study is two-fold: firstly,     the research focuses on assessing the reliability and usefulness of NPO carried out at     patient's home in the context of SAHS detection and, secondly, the study aims at assessing     the performance of an automatic regression model of the AHI by means of neural networks using     information from NPO recordings. To achieve this goal, both PSG and NPO studies are carried     out. A polysomnography equipment (E-Series, Compumedics) is used for standard in-hospital PSG     studies, whereas a portable pulseoximeter (WristOX2 3150, Nonin) is used for ambulatory NPO.     NPO is carried out the day immediately before or after the PSG at patient's home. Patients     are assigned to carry out the NPO study before or after the in-hospital PSG randomly. In     addition, in-hospital attended oximetry is also performed simultaneously to the PSG using the     portable pulseoximeter.   "
87309|NCT02143284|"     EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on     the model). These optical properties are to be examined and reviewed in this trial (mainly     usability and safety)   "
87310|NCT02143271|"     This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single     administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal     dialysis.   "
87319|NCT02143154|"     While it is clear that intrapartum antibiotics reduce neonatal GBS infection rates, the     mechanism by which these drugs prevent neonatal GBS is not well established. One postulated     theory is antibiotics work to reduce bacterial load in the birth canal; thus decreasing fetal     exposure during labor and delivery. To our knowledge, the relationship between vancomycin and     vaginal GBS colony counts has never been studied. In this prospective cohort study, our     objective is to determine the relationship between intrapartum IV vancomycin and vaginal GBS     colony counts.   "
87320|NCT02143141|"     The investigators are attempting to see if eliminating the amount of long acting spinal     narcotic during cesarean section delivery will demonstrate pain scores with movement when     evaluated 24 hours postoperatively as those that receive the standard dosage of spinal     narcotic when combined with oral acetaminophen or placebo. The investigators also are     evaluating if there are decreased side effects related to decreased narcotic usage.   "
87311|NCT02143258|"     Increased Intracranial Hypertension (IIH), also known as Pseudotumor Cerebri, is defined by     increased cerebral spinal fluid (CSF) pressure in the absence of intracranial, metabolic,     toxic or hormonal causes of intracranial hypertension. It is characterized by headaches,     tinnitus and visual loss, due to optic atrophy, in 50% of cases. Surgical treatments, such as     CSF shunt placement and optic nerve sheath fenestration (ONSF), are indicated in case of     failure or non-compliance (owing to side effects) of medical treatments (that mainly includes     weight loss and drugs, such as Carbonic Anhydrase Inhibitors). However, these surgical     treatments are limited by relative high complications and recurrence rate. Indeed,     improvement in visual function after ONSF is often transient and the risk of complications,     including visual loss, pupillary dysfunction, and vascular complications is up to 40%. With     no better treatment option, intraventricular or lumbar shunt placement has become the     traditional treatment for medically refractory IIH, despite poor results. Indeed, series of     patients with IIH treated with shunt replacement report a complications rate (shunt     occlusion, disconnection, infection or intracranial hematoma formation) around 50% and a     failure rate up to 64% within 6 months. As a consequence, shunt revision is often required     and efficacy of the technique to control the disease is questionable.      The role of intracranial transverse sinus stenosis in IIH has recently gained a particular     interest. Despite the fact that transverse sinus stenosis in IIH may be due to increased     intracranial pressure, some authors believe that the rise in intracranial pressure and its     effect are worsened by the secondary appearance of the venous sinus stenosis. To date, very     few complications have been reported in IIH patients with venous sinus stent placement.   "
87312|NCT02143245|"     The purpose of this study is to determine the efficacy of retrieving tissue samples via an     x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure     using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is     done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the     investigators hope to avoid more invasive intervention if it is not needed. Some patients may     appear to have an infection but once the biopsy is taken and the results are read, there may     not be an infection and therefore no need for a revision surgery.   "
87313|NCT02143232|"     The investigators propose to deploy an interactive device to monitor the patient's recovery     and vital signs at home after joint replacements. These will be early discharge patients on     the same day or the next morning. The goal will be to support early discharges by creating a     safe, controlled, and monitored environment at home.   "
87314|NCT02143219|"     Metastatic pancreatic carcinomas represent the 5th cause of cancer death in France (#8000 per     year). The median age at diagnosis is 69 and 74 in male and female respectively. When the     5-Fluorouracile has been used as a single agent with a limited efficacy during more than 20     years, the onset of gemcitabine in 1995 has led to a moderate increase of median survival     (from 4.41 to 5.65 months) and overall survival at 1 year (2 versus 18%). Recently, in a     phase II followed by a phase-III study, a French collaborative group has demonstrated the     benefit of FOLFIRINOX  regimen versus gemcitabine alone, in terms of median survival (11.1     versus 6.8 months), progression-free survival (6.4 versus 3.3 months) and response rate (31.6     versus 9.4%).      Although more hematologic (neutropenia) and GI toxicities were observed, FOLFIRINOX was     acceptable as a new standard regimen for the majority of patients under the age of 70 with a     good Performans Status. To reduce the toxicity of FOLFIRINOX in elderly patients (> 70 yo),     pharmacogenetic monitoring of 5-FU and Irinotecan key metabolism enzymes (DPD and UGTA1) may     be easily performed. The methodology of the study is to use the Bryant & Day statistical     method, allowing to consider simultaneously as principal objective, the response rate     (efficacy) and the tolerance (preservation of autonomy daily living, Katz index): this design     is particularly fitting in a study for elderly patients who represent half of the pancreatic     carcinoma population.   "
87315|NCT02143206|"     This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the     chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve     participation in a pulmonary rehab program compared to the Nustep elliptical. The main     outcome of participation will be measured by the number of exercise sessions the patient is     able to complete during their pulmonary rehabilitation program. In addition, distance walked     in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index     score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both     groups. It is believed that the new machine will provide better overall outcomes compared to     the traditional machine.   "
87316|NCT02143193|"     This study will compare standard methods of stabilizing a newborn's temperature after birth     with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will     look at the effects of each warming method on the timing of newborns' initial bath and the     effects on newborn initiation and percent weight loss by discharge.      The study will use a randomized controlled trial (RCT) design to test a clinical intervention     at TriHealth Good Samaritan Hospital. Study participants will be randomized to the     intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately     after vaginal birth, or to the control group (CG), which will receive standard care for     newborn and mother immediately after vaginal birth.      This study will test the hypothesis that mother-baby STS contact implemented immediately     after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS     (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's     temperature stabilizes after the initial bath will result in:        1. Improved newborn temperature stability and thermoregulation for newborns whether breast          or formula-fed.        2. Initiation of effective breastfeeding behavior within 90 minutes of birth and the          addition of at least one more breastfeeding within four hours of birth for breastfed          newborns.        3. Avoidance of newborn weight loss of 10% or greater.   "
87317|NCT02143180|"     Our study is a prospective multicenter research and the aim is to explore a variety of     suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get     the corresponding diagnosis threshold, with the domestic common pathological S stages as the     gold standard.   "
87318|NCT02143167|"     Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately     40% of MS patients suffering from this by overcoming partly or total conduction block due to     demyelination.      Resistance training has been shown to provide the same kind of benefits for patients by     targeting the muscular component of the motor unit. Thus by combining the two it is likely to     see an synergistic effect.      This trial is designed as a double blind, randomized placebo controlled trial with subsequent     cross-over.      Participants in the two arms will go through the same progressive training program targets at     the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives     placebo. in the the end there is another four weeks of training after cross-over has been     performed.   "
87325|NCT02143076|"     Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as     prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help manage     SCD. Electronic adherence monitoring is widely considered the gold standard in objective     adherence measurement. These monitors provide continuous, real-time records of medication     adherence and reveal problematic behavior patterns, including underdosing, overdosing,     delayed dosing, drug holidays (i.e. where individuals do not take medications for a     specified interval of time), and white coat adherence (i.e., a pattern of drug adherence as     a function of time where individuals display good adherence immediately before and after     clinic attendance with worsening adherence in the period between).      Overall, electronic adherence measures are considered valid, reliable, and accurate, with     clear advantages over pharmacy refill records, physician estimates and self-report measures.     Currently, only one electronic measure capable of monitoring medications in both pill and     liquid form is being manufactured: WisePill and WiseBag. While data are limited regarding its     validity and reliability, preliminary data support the use of Wise technology to measure     adherence to medication. The current study will determine the Wise device's ability to     feasibly measure adherence to liquid and solid form HU medication in a pediatric SCD     population.   "
87326|NCT02143063|"     Reinforcement interventions have pronounced effects on reducing cocaine use. This study will     evaluate a novel approach in which reinforcement frequency varies by patient performance. To     test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard     care, standard care plus traditional twice weekly reinforcement, or standard care plus     adaptive variable interval reinforcement.   "
87327|NCT02143050|"     The main purpose is to evaluate the clinical response, safety and survival of the FDA     approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators     hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the     B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and     improve clinical outcomes in terms of objective response rates and survival in metastatic     melanoma patients.   "
87328|NCT02143037|"     Contingency management (CM) is highly efficacious for reducing substance use, and recent data     suggest that reinforcing attendance at treatment can significantly improve treatment     outcomes. Importantly, CM interventions that reinforce attendance are more likely to be     adopted clinically than those that reinforce abstinence. Having objective indicators of     drinking outcomes, nevertheless, is critical for quantifying the benefits of attendance-based     CM treatment in alcohol abusing populations. New technology is now available to gauge alcohol     use in patients' natural environments. The Secure Continuous Remote Alcohol Monitor (SCRAMx®)     continuously monitors alcohol consumption 24 hours a day. As such, it may be ideal for     objective evaluation of alcohol consumption during treatment intervention studies, including     those that involve CM.      In this study, 114 patients participating in community based outpatient treatment programs     for alcohol use disorders will wear SCRAMx for a 12-week period. They will be randomized to     standard care or standard care plus CM, with reinforcement contingent upon attendance at     treatment. The investigators will assess treatment attendance and alcohol use via SCRAMx and     self reports. The investigators expect that patients randomized to the CM intervention will     remain in treatment longer and show reductions in both SCRAMx assessed and self reported     drinking days relative to those randomized to standard care.   "
87329|NCT02143024|"     Despite the public health importance of clinical depression, more than 50% of depressed     adults receive inadequate or no treatment, with even higher rates of under-treatment in men     and minorities. Family members and/or friends often assist older adults in their health care     and may help overcome barriers to formal care, yet there is a lack of primary care-based     interventions that mobilize family members and friends to improve depression treatment. In     partnership with a community-based clinic, this research will address this scientific gap by     developing and then testing the feasibility and acceptability of a family-based intervention     that can be delivered pragmatically in a primary care setting serving large numbers of older     minorities.   "
87330|NCT02143011|"     The main objectives of this study are to test the hypotheses that: 1) consumption of     beverages sweetened with sucrose will increase risk factors for cardiovascular disease to a     greater extent than a naturally-sweetened fruit juice such as orange juice, and 2) chronic     psychological stress may augment the adverse metabolic effects of sugar intake. The study     intervention consists of 2-week's consumption of 25% of energy as sugar provided either as a     sucrose-sweetened beverage or naturally-sweetened orange juice.   "
87383|NCT02142296|"     Primary Objectives:      To assess the efficacy of intravitreal administered Eylea in preventing visual loss in     subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular     age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared     to Baseline.      Secondary Objectives:        1. To assess the safety and tolerability of repeated intravitreal administration of Eylea          in subjects with the PED subtype of neovascular AMD for a period of 1 year        2. To assess the effect of repeated intravitreal administration of Eylea on Central          Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.        3. To assess the effect of repeated intravitreal administration of Eylea on vision related          quality of life in subjects with PED study type of neovascular AMD assessed using the          NEI/VFQ-25 questionnaire   "
87331|NCT02142998|"     Obesity has become a significant health problem in Canada. It is known to be a risk factor     for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to     lose weight fail, patients often consider bariatric surgical procedures as the next step. The     two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and     Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH     monitoring, as it is the most objective method to document the reflux, assess the severity     and monitor the response to treatment of the disease. In the last few years LSG has gained in     popularity due to its simplicity and short operative time. Currently the comparison between     bariatric surgery and GERD symptoms is very one sided. There are significant numbers of     studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms,     however there is little evidence that states the same about LSG. This means that the     relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24     hour pH monitoring and validated CRFs at different follow up time points will contribute     greatly to our understanding of what this relationship might be.   "
87334|NCT02142959|"     Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation     therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to     its direct physical complications and the resulting impact on overall quality of life, it can     also be a dose-limiting toxicity requiring changes to the prescribed course of radiation     therapy. The most common strategy employed in an attempt to prevent or minimize radiation     dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the     area clean, and minimizing exposure to potential mechanical irritants, such as scratching and     rough clothing. However, this strategy has been shown to lack clinically significant     efficacy. Consequently, there is a clinical need for new treatments that are effective in     protecting against radiotherapy-induced oxidative stress and the subsequent development of     radiation dermatitis.      Based on data from previous studies in animals and humans, Reata believes that omaveloxolone     (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology     patients undergoing radiation therapy.      This randomized, double-blind, vehicle-controlled, parallel-group trial will study the     efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3%     and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is     recommended.   "
87335|NCT02142946|"     The primary objective of this project is to track changes over time in balance control     parameters measured during stance and gait for different groups of multiple sclerosis (MS)     patients. Our primary goal is to determine whether these changes in balance control over time     predict transitions in MS progression to a more disease affected state, and are different     from changes over time for patients with balance deficits due to vestibular sensory     disorders. A part of this goal is also to determine whether these changes in balance control     are correlated with changes in patients' self-reported deficits and are similar to those     changes in balance control of patients with peripheral vestibular loss. The secondary     objective is to determine for multiple sclerosis (MS) patients the relationship of their     balance parameters to different gait speeds, in order to advise them on, and promote via     feedback, safe walking speeds. Fulfilling the first of our objectives would lead to better     tracking of MS disease changes over time, earlier quantification of onset of symptoms     suggesting a worsening of disease status, and, we assume, greater patient satisfaction     knowing that quantification of symptoms fits subjective feelings of balance deficits during     stance and gait. Achieving the second objective would lead to improved balance during gait.     We aim to carry out these objectives using equipment (SwayStar) which we have proven is     sensitive to MS induced balance deficits {2}, but costs far less to operate and maintain than     previously used quantification tools. We aim to investigate the balance deficits during gait     in different MS patient groups using a multimodal approach with a SwayStar system (analysis     of balance during stance and gait in terms of trunk-pelvis movements near the centre of mass)     and patient questionnaires.   "
87336|NCT02142933|"     1. At the University Hospital Basel, Switzerland, a simplified screening for group B          streptococci (GBS) of vagina and perineum has been performed since several years.          Reliable detection of GBS is critical to prevent GBS transmission during delivery with          antimicrobial prophylaxis. Transmission of GBS to the neonate may otherwise lead to          severe infection and complications in the neonate. Centers for Disease Control and          Prevention (CDC) and other international organizations recommend a vaginal and          additional rectal swab.We therefore aim to test this simplified screening against the          international gold standard.        2. Antibiotic resistant bacteria may reside in the genital tract of an expected mother and          may be transmitted to the new-born during delivery. In case of infection of the pregnant          woman or the neonate, application of standard antimicrobial treatment will          insufficiently cover these extended spectrum beta-lactamase (ESBL) producing bacteria.          Therefore, colonization with ESBL in pregnancy needs to be known to potentially deliver          adequate antimicrobial treatment.   "
87337|NCT02142920|"     The purpose of the study is to characterize how PF-05212384 is metabolized in the body     following a single intravenous dose of radioactively labeled drug ([14C]-PF-05212384).   "
87384|NCT02142283|"     The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical     management leads to superior clinical outcomes at 90 days as compared to medical management     alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment     is initiated within 6-24 hours after last seen well.   "
87338|NCT02142907|"     In a general radiation oncology practice, breast cancer typically comprises approximately 25%     of the total patient caseload.1 Surgery is the primary modality of treatment. Radical     mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving     surgery followed by radiation therapy to the intact breast is an established standard of care     for the majority of women with early stage invasive breast cancer. Recommended techniques for     breast-conservation treatment are local excision of the primary tumor, preferably with clear     margins, axillary lymph node dissection, and breast irradiation (45 to 50 Gy), usually with a     boost (10 to 20 Gy, depending on tumor size and status of the surgical margins).      The aim of this study is to compare the two boost regimen 10Gy/5#/1 week with 16Gy/8#/1.5     weeks in post lumpectomy patients of early stage breast cancer, following whole breast     irradiation (WBI).      The study will include 50 patients, (25 in each arm) of early stage post lumpectomy breast     cancer patients. Each patient will be treated by WBI followed by tumor bed boost with either     electron beam therapy or 3D CRT. The primary end point of the study will be assessment of     acute and late radiation toxicities, cosmetic score analysis and local control between two     schedules. Secondary end points will be recurrence-free survival.   "
87339|NCT02142894|"     To compare the results of the investigational test to the currently approved QuantiFERON-TB     Gold In-Tube test.   "
87351|NCT02142738|"     This is an efficacy and safety study to assess pembrolizumab (MK-3475/SCH 900475) compared to     standard of care (SOC) platinum-based chemotherapies in the treatment of participants with     previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing     Non-Small Cell Lung Cancer (NSCLC). The primary hypothesis of this study is that participants     with PD-L1 strong NSCLC will have a longer Progression Free Survival (PFS), as assessed by     Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with     pembrolizumab than when treated with SOC platinum-based chemotherapies.   "
87340|NCT02142881|"     To date, most observational and all intervention studies have defined hypertension on the     basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or     ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause     mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive     (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal     ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and     sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of     patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP     (masked hypertension). We demonstrated that, among participants from the Chronic Renal     Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and     elevated proteinuria are associated with increased odds of masked hypertension. Additionally,     participants with masked hypertension had increased risk for target organ damage as assessed     by left ventricular mass and pulse wave velocity. These results in participants with CKD are     consistent with prior studies in patients with normal renal function that demonstrated a     two-fold increased risk for cardiovascular events in patients with masked hypertension     compared to patients with normal clinic and ambulatory BP. Despite this elevated risk for     adverse outcomes, patients with masked hypertension have been excluded from hypertension     trials because of their normal clinic BP. Therefore, it is unknown whether the reduction in     target organ damage and adverse cardiovascular outcomes associated with treatment of     hypertension extends to patients with masked hypertension. To address this important gap in     knowledge, we are planning a randomized, controlled trial to evaluate whether     antihypertensive treatment can modify BP patterns in patients with masked hypertension, that     is, convert them to controlled clinic and ambulatory BP. We will also evaluate the effect     antihypertensive treatment on target organ damage in patients with masked hypertension. The     current study is a pilot randomized controlled trial to evaluate the feasibility of the     planned trial and the effect of antihypertensive therapy on clinic and ambulatory BP,     proteinuria, and target organ damage in patients with masked hypertension.   "
87341|NCT02142868|"     To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative     advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line     patients only).   "
87342|NCT02142855|"     The first goal of this study is the follow young and older people over a period of 8 weeks to     define the processes responsible for loss of muscle length and width in age-related muscle     wasting (sarcopenia) and allow us to look at age-related differences in tendon. Secondly, we     will assess two different exercise interventions for reversing human sarcopenia; one which     involves shortening of the muscle and the other which involves lengthening, whilst also     studying why these exercises work the way they do. This project will have significant     implications for our understanding of the control of skeletal muscle and tendon size in     humans, particularly in relation to sarcopenia and the surrounding health issues.   "
87343|NCT02142842|"     Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.   "
87344|NCT02142829|"     This study was conducted to compare the effectiveness of two local pain control methods in     bariatric patients by assessing the amount of postoperative pain and amount of postoperative     pain medications needed. This information was used to determine which local anesthetic     provided the best pain control.   "
87345|NCT02142816|"     Targeting the amount of fluid given to measurements of the patients own fluid status during     major abdominal surgery has been linked with improved speed of recovery of gut function and     reduced length of hospital stay, mortality and complications.      Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more     invasive forms of monitoring to direct how much fluid to give.      The study aims primarily to measure and compare how much fluid is given when guided by PVI     compared to the established technique; oesophageal doppler during major abdominal surgery.      The study will compare 40 patients undergoing major elective abdominal surgery. Patients will     receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the     study will examine biochemical markers, length of hospital stay and how frequently     complications occur   "
87346|NCT02142803|"     This phase I trial studies the side effects and best dose of raptor/rictor-mammalian target     of rapamycin (mTOR) (TORC1/2) inhibitor MLN0128 when given in combination with bevacizumab in     treating patients with glioblastoma, a type of brain tumor, or a solid tumor that has spread     and not responded to standard treatment. TORC1/2 inhibitor MLN0128 may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,     such as bevacizumab, may interfere with the ability of tumor cells to grow and spread.     Bevacizumab may also stop the progression of tumors by blocking the growth of new blood     vessels necessary for tumor growth.   "
87347|NCT02142790|"     This is a open-label study in patients with metastatic breast cancer to evaluate the     antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to     3-weekly regimen.   "
87348|NCT02142777|"     The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's     Disease (AD).   "
87349|NCT02142764|"     Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the     central nervous system. In spite of many works, the data in the literature concerning the     antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.   "
87406|NCT02141984|"     Approximately 600 pediatric patients prescribed Humira Injection in usual practice according     to the approved Korean product label will be registered into this observational study.     Baseline data will be obtained at enrollment including demographics, underlying diseases and     complications especially in regard to purified protein derivative (PPD) skin test, and chest     X-ray. At routine visits for Humira Injection administration, which will occur according to     usual medical practice, concomitant medication information and adverse events information     will be collected for up to 70 days after the last administration of Humira.   "
87350|NCT02142751|"     Enterobacterieaceae (and specially Escherichia coli) showing resistance due to     multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by     chromosomal mechanisms have spread worldwide during the last decades. This is important     because many of these isolates are also resistant to other first-line agents such as     fluoroquinolones or aminoglycosides, leaving few available options for therapy, and this     condition is associated with increased morbidity- mortality and length of hospital stay.     While carbapenems are considered the drugs of choice for multidrug-resistant Escherichia coli     and AmpC producers, recent data suggests that certain alternatives may be suitable for some     types of infections.      At the present time, finding therapeutic alternatives to carbapenems and cephalosporins for     the treatment of invasive infections due to multidrug-resistant Escherichia coli is critical.     Fosfomycin was discovered more than 40 years ago but was not investigated according to     present standards, and thus is not used in clinical practice except in desperate situations.     It is one of the so-considered neglected antibiotics with high potential interest for the     future.      With the aim of demonstrate the clinical non-inferiority of intravenous fosfomycin compared     to meropenem or ceftriaxone in the treatment of bacteraemic urinary tract infections caused     by multidrug-resistant Escherichia coli . The investigators propose a real practise     randomised, controlled, multicentre phase III clinical trial to compare the clinical and     microbiological efficacy and safety of intravenous fosfomycin (4 grammes every 6 hours) with     meropenem (1 gramme every 8 hours) or ceftriaxone (1 gramme every 24 hours) as targeted     therapy of the previously specified infection; change to oral therapy according to predefined     options is allowed in both arms after 5 days. Follow-up for the study is planned up to 60     days.   "
87352|NCT02142725|"     The purpose of this study is to compare two different dosing regimens of phosphatidylcholine     versus placebo for the induction of remission in ulcerative colitis patients non-responsive     to standard mesalamine treatment.   "
87353|NCT02142712|"     Stroke is the 4th leading cause of death in United States with an estimated 1 death every 4     minutes. On average, someone suffers from stroke in United States every 40th second. Stroke     recurs in 1 out of 4 stroke patients. About 87% of the strokes are as a result of ischemic     insult. The total economic burden from stroke accounts to 38.6 billion dollars per year.     Stroke is also one of the leading causes of long term disability. Current stroke therapies     concentrate mainly on acute revascularization, sub-acute rehabilitation and secondary     prevention.      Neuroprotection is not the mainstay of treatment modality as there are no effective regimen     which has satisfied stroke clinicians and researchers. Many neuroprotection agents have shown     excellent pre-clinical results but have failed in clinical translation. Thus we need to find     new treatments in order to decrease the mortality and morbidity caused by stroke.      The investigators hypothesize that adopting a narrower therapeutic window, with treatment     initiation in the first six hours, may demonstrate a positive or significant short and long     term neuroprotective effect from NMDA/Glutaminergic or histaminergic antagonism when compared     with standard of care.   "
87354|NCT02142699|"     A recent analysis of over 4500 cardiac surgical patients at the Royal Infirmary of Edinburgh     has confirmed that acute kidney injury (AKI) is not only a relatively common post-operative     complication but is associated with prolonged hospital stay, and increased risk of death.     There is currently no specific therapy available except supportive care.      In laboratory studies, heme arginate (HA), a drug licensed for human use, has been shown to     upregulate the anti-inflammatory enzyme hemeoxygenase-1 (HO-1) and protect aged mice from     acute kidney injury.      This study will bring this research into the human arena. It will aim to evaluate the minimum     effective dose of HA and verify its safety in this specific group of patients. This will be     the next step in investigating if HA could be a potential protective treatment for reducing     AKI in patients about to have cardiac surgery.      Patients who are due to have cardiac surgery and are aged 60 or above will be approached for     inclusion in the study. If agreeable, they will be randomly assigned to receive either HA at     a dose of 1mg/kg or 3mg/kg. There will be 10 patients in each group.      Blood tests will be taken just before the study drug is given, at 6 hours, 24 hours and 7     days post dose. These samples will be used to examine the effect of HA on HO-1 at different     doses, and will verify drug safety. Any adverse effects of the drug will be evaluated,     although HA has an excellent safety profile when used as it is currently licensed for acute     porphyria. Urine samples will also be collected to assess inflammation and quantify urinary     biomarkers of AKI. This will set the scene for a randomised clinical trial of HA in cardiac     surgical patients at high risk of AKI.   "
87355|NCT02142686|"     The aim of this study is to compare different filling pressures   "
87356|NCT02142673|"     The study aims to compare different filling pressures in operative outpatient hysteroscopy.     Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine     cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in     group1, 60mm Hg in group 2 and 40mmHg in group 3.   "
87357|NCT02142660|"     The application of SprayShield during a laparoscopic band removal (first surgical step) will     be evaluated to see if the postoperative adhesions between the stomach, the left liver and     the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or     a sleeve gastrectomy.   "
87358|NCT02142647|"     Current research shows that dairy protein accelerates infant weight gain, which is a risk     factor for later on obesity and metabolic syndrome. However, dietary protein from other     sources haven't been studied yet. This longitudinal study will compare two complementary     feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body     composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy     infants at approximately 5 months of age will be randomized to either a meat protein, or a     dairy protein group with complementary protein mainly from meat or dairy. Infants will     consume one of these diets for 7 months (6-12 months of age) and infant growth, body     composition, growth biomarkers and gut microbiome will be measured to compare between groups     and over time.   "
87359|NCT02142634|"     The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of     active incomplete microscopic colitis.   "
87430|NCT02141672|"     To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete     remission after 24 weeks of therapy in subjects with active lupus nephritis.   "
87360|NCT02142621|"     Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It     impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with     birth weight < 1000g. BPD is associated with multiple long-term adverse outcomes including     chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined     as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks     postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent     episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the     development of these impairments. Gastroesophageal reflux (GER) contributes to these     mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately,     clinically available methods to diagnose GER in infants are unreliable. Moreover, acid     suppressive agents are both ineffective and carry high risk of serious life-threatening     morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.      This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway     complications of GER and and whether this methodology can aid in identifying individual     infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.      Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to     gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and     improve a validated BPD severity score (secondary outcome).      The investigators hypothesize that 80% percent of enrolled infants will have significantly     fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and     will have this feeding method formally recommended.      Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared     to gastric feeds reduce airway complications of GER in infants with severe BPD.      The investigators hypothesize that transpyloric compared to gastric feeds will be associated     overall with a 15% reduction in number of daily intermittent hypoxemic events.   "
87361|NCT02142608|"     Pilot study to evaluate the sensitivity and specificity of BR55 targeting for prostate cancer     nodules with Gleason score greater than or equal to 7.   "
87362|NCT02142595|"     The investigators designed a study to determine whether dexmedetomidine versus midazolam     combined with spinal anesthesia would provide same postoperative sleep quality in patients     undergoing transurethral prostatic resection.   "
87387|NCT02142244|"     Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis     (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the     standard procedure - a fluorescent contrast (indocyanine green) using special light (near     infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.   "
87363|NCT02142582|"     Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home     Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid loss     due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these patients.     The investigators believe that taste of the standard ORS is the biggest reason why these     patients are not complaint. The new ORS in the market has been prepared with this in mind.     The investigators want to study if this new ORS will improve the compliance in this patient     cohort.   "
87364|NCT02142569|"     The purpose of this study is to determine the effects of a palm-oil derived tocotrienol (TRF)     supplement or Chinese red yeast rice (CRYR) individually and in combination on blood     cholesterol, and particularly LDL cholesterol, in individuals who have either elevated or     normal cholesterol levels. Tocotrienols are members of the vitamin E family, and are found in     barley, oats, rye, coconut oil and rice bran oil, but the richest source of tocotrienols is     palm oil. Certain of these tocotrienols have been shown to be effective in lowering LDL (or     'bad') cholesterol, with no adverse effects on the HDL (or 'good') cholesterol.   "
87365|NCT02142556|"     Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR) in     patients with schizophrenia switched from other antipsychotics which were suboptimal due to     insufficient efficacy or insufficient tolerability.      Methods:      This was a 12-week, open-label study conducted in the Chinese population in Taiwan.     Quetiapine XR was administrated at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after     day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within     400-800 mg per day, depending on the clinical response and tolerability of the patients.   "
87366|NCT02142543|"     This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to     evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous     stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of     less than 48 hours duration. It was randomly determined which powder was used first; all     subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder     twice daily and maintained a daily log recording the size of the ulcer, its erythema score,     and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer     was resolved.   "
87367|NCT02142530|"     This research study is evaluating a drug called carfilzomib used in combination with another     drug called belinostat with participants who have relapsed or refractory non-Hodgkin lymphoma     (NHL).   "
87368|NCT02142517|"     Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and     also affect significantly the surgical outcomes . The incidence of POPF after     pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and     mortality after pancreaticoduodenectomy are usually related to surgical management of the     pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues     to be a challenge at high volume centers. The variety of reconstruction is a reflection of     the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many     studies compared both techniques, but their surgical outcomes still unclear.The aim of the     study was to assess the effectiveness and surgical outcomes of both techniques of PJ after     pancreaticoduodenectomy.   "
87369|NCT02142504|"     The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like     particle (VLP) vaccine for further development by assessing the rates of serious adverse     events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs,     Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from     the trial.   "
87370|NCT02142491|"     The objective of this study is to verify the clinical tolerance to the vaccine Flumist     (intranasal live attenuated influenza vaccine) in a population of egg allergic children. More     specifically, the investigators want to estimate the risk of severe allergic reaction arising     within 24 hours following the vaccination of egg allergic with Flumist.   "
87403|NCT02142036|"     The metastatic lesions may be very different from the primary tumor because of intrinsic     tumor heterogenity, clonal selection through metastatic process and following previous     cytotoxic treatments. Metastatic tumor harboring actionable targets or signaling pathways may     respond to inhibitory agents directed against specific aberrations irrespective of tumor     origin. In the MetAction study, patients will receive therapy based on molecular aberrations     in the metastatic lesions, actionable target identification (ATI), rather than on     histological tumor type.      The ATI rate in an unselected metastatic patient population is uncertain, and response rates     associated with ATI based targeted therapy have hardly been reported. In this perspective,     The MetAction study is essentially a feasibility study aiming to tailor metastatic cancer     therapy based on genomic profiles.   "
87371|NCT02142478|"     Physical activity (PA) benefits both physical and psychological health, yet the majority of     UK adults are physically inactive. Exercise for Health (EFH) is a General Practitioner (GP)     exercise referral scheme run in Liverpool for people who are inactive with a medical     condition. Patients are referred by their GP practice, where they receive 12 weeks of     subsidised exercise classes at their local leisure or community centre.      In 2012, one of the thirteen EFH centres (Centre A) introduced some changes to try and     improve EFH at their centre. These changes included:        -  a pre-scheme meeting with a health trainer, to help the patient decide if EFH is for          them.        -  exclusive classes (gym or activities) available daily for EFH participants (compared to          gym only classes two or three times a week in other centres).      This non-randomised study will compare the effectiveness of the adapted EFH (Centre A) with     standard EFH delivery (Centre B). All participants referred to centre A (n=100 approx) or     centre B (n=100 approx) during the study period will be invited to take part. Changes in     self-reported PA, PA self-efficacy and psychological wellbeing will be measured at the end of     EFH (12 weeks) and at 12-month follow-up. A subsample of participants (n=15 from each centre)     will take part in qualitative interviews to explore the factors that contribute to     effectiveness.      A secondary aim is to explore psychological factors contributing to any differences between     the two centres. Self-determination theory suggests that where participants feel they are     offered choice, feel they are competent at exercise, and feel connected to people they     exercise with, they will be more intrinsically motivated and more likely to continue     exercising. Therefore it is hypothesised that participants attending the adapted EFH will be     more motivated and more likely to continue exercising.   "
87372|NCT02142452|"     The investigators will test the efficacy of a tailored behavioral lifestyle modification     program to support cardiovascular health in postpartum women with excessive gestational     weight gain. This program will include a mobile health texting component postpartum to     support changes in nutrition and physical activity. The investigators will randomize women     into either the control arm (usual care) or the intervention (usual care + mobile health     program postpartum). The women will be recruited during their 3rd trimester once they have     been identified as gaining too much weight according to the 2009 IOM guidelines during     pregnancy.   "
87373|NCT02142439|"     Strength training has been found effective for enhancement of bone health, muscle strength     and body composition among premenopausal women from the general population, however it is     unclear to what extend strength training might improve these parameters among women with     eating disorders. The aim of this study is therefore to examine acute and long-term effects     of strength training among persons with eating disorders. The study is a randomized,     controlled, single-blinded trial with three intervention groups and one control group. The     three intervention groups will perform different volumes of strength training. The     intervention period is 16 weeks with three sessions per week. At pretest, posttest, and 6     months, 12 months and 24 months follow-up, the following variables will be measured: bone     health, muscle strength, power, body composition hormone levels, physical activity level and     compulsivity, body awareness, quality of life, and eating disorders psychopathology.     Qualitative in-depth interviews will be carried out to explore the participants' experiences     with strength training. The study is carried out in Norway, and is performed in collaboration     with Telemark University College, University of Agder, Norwegian school of sport sciences and     Modum Bad psychiatric center. The results from the study might implicate on strength training     as part of treatment for eating disorders.   "
87374|NCT02142426|"     The purpose of this study was to pursue statistical analysis on a series of molecular     laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and     other aspects of microbial diversity in chronic wounds.   "
87375|NCT02142413|"     The primary aim of this prospective observational study is to investigate whether an enhanced     diagnostic MRI work-up (including cardiac MRI, angiography of the aortic arch and the     brain-supplying arteries) combined with an in-hospital Holter-ECG of up to 5 days duration     leads to a significant increase in relevant pathologic findings with respect to stroke     aetiology as compared to the findings obtained by a routine diagnostic work-up (including     stroke unit monitoring, 24h-Holter-ECG, echocardiography, Doppler-ultrasound of the     brain-supplying arteries) in patients with acute ischemic stroke and no atrial fibrillation     according to past medical history or baseline ECG. A better understanding of the stroke     aetiology may improve secondary stroke prevention and long term outcome.   "
87376|NCT02142400|"     This is a randomised, double-blind, placebo-controlled multiple ascending single study. It is     hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week     treatment period and will result in increases in reticulocyte count and haemoglobin     concentrations in healthy male volunteers   "
87377|NCT02142387|"     Despite aggressive CPR training, the outcome of cardiac arrest is not good. The problem is     method of education. So, the investigators want to add the dispatcher-assisted CPR simulation     into conventional CPR training. In this study, the investigators aim is to investigate the     effect of newer CPR training program.   "
87378|NCT02142361|"     Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted     with Avaira toric silicone hydrogel contact lenses over 1 week of wear.   "
87379|NCT02142348|"     To popularize knowledge of prevention and health care of osteoporosis.To investigate the     prevalence of primary osteoporosis in community residents.   "
87380|NCT02142335|"     The purpose of this research study is to test an experimental combination of drugs to     determine if they can cause shrinkage or even complete disappearance of your melanoma. The     two drugs being tested in combination are Rituxan and Abraxane   "
87381|NCT02142322|"     This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil,     Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.   "
87382|NCT02142309|"     Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus     algorithms have been developed to help clinicians to select among the numerous medications     and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c)     of <7%.      AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications,     when combined with metformin, on glycemia-lowering effectiveness.   "
87404|NCT02142010|"     The purpose of this study is to evaluate the pathological complete response (pCR) rate in     breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin     preoperative regimen.   "
87405|NCT02141997|"     This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study designed     to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple     doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are inadequately     responding to methotrexate (MTX) treatment.   "
87431|NCT02141659|"     To evaluate the tolerability and safety of TAK-385 in patients with androgen deprivation     treatment-naïve non-metastatic prostate cancer   "
87385|NCT02142270|"     Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to     assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a     prospective, multicenter, community-based registry monitoring all cases of cardiac arrest     occurring in victims > 15 years old. Investigators will use the definition of established SCD     if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed     collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable SCD     if an unexpected death without obvious extracardiac cause occurred within the previous 24     hours. After approval from institutional boards, Investigators will record demographic,     clinical, electrocardiographic and biological variables of SCD victims (including survivors     of cardiac arrest) in several sub-Saharan African cities. All deaths occurring in residents     of districts of interest will be checked for past medical history, circumstances of death,     and autopsy report (if possible). Investigators will also analyze the employment of     resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient     populations throughout countries. Conclusion This study will provide comprehensive,     contemporary data on the epidemiology of SCD in sub-Saharan Africa and will help in the     development of strategies to prevent and manage cardiac arrest in this region of the world.   "
87386|NCT02142257|"     The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy     over 5 years of treatment with regards to weight loss, quality of life, complications,     adverse events, and health economics.   "
87409|NCT02141945|"     The purpose if this study is to measure the sensitivity, specificity and accuracy of the     Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon     polyps or colorectal cancer.   "
87388|NCT02142231|"     Test anxiety is a well-known phenomenon in general population, but only few scientific     advances have been made in order to fully understand and prevent this circumstance.      The number of students which use neuro enhancement to improve their performance and to     prevent test anxiety, is increasing. A US-survey estimated that almost 7% of students in US     universities have used prescription stimulants against anxiety, and that on some campuses, up     to 25% of students had used them in the past year.      Acupuncture might act as an alternate. Several trials could demonstrate, that different forms     of acupuncture could relieve symptoms of pre-exam anxiety syndrome significantly and that     this therapy was highly safe. In special, the investigation of single point effects in test     anxiety could be of general interest. The acupuncture point with the most convincing evidence     up to date is Heart 7. Yet, its effectiveness has mainly been chosen in combination with     other acupuncture points and not as single remedy in test anxiety. Therefore we establish a     trial investigating the immediate needling effects at Heart 7 on the reduction of test     anxiety.      Therefore qe implemented a validated stress test, the Trier Social Stress Test TSST, which is     known to provoke serious stress responses in healthy subjects. 24 medical students with test     anxiety in there history will be randomised to two interventional groups (verum acupuncture     and laser acupuncture), being treated and then pass this test. Main outcome is the increase     of cortisol in saliva, which is the standardized measure of stress response used in this     paradigm.   "
87389|NCT02142218|"     The purpose of this program is to provide treatment with nivolumab to subjects with Stage III     or Stage IV advanced melanoma.   "
87390|NCT02142205|"     The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002,     Tysabri®) in the study population (Russian participants with relapsing remitting multiple     sclerosis). The secondary objectives are to look at evaluation of severity of relapse,     hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS),     functional tests, quality of life self-assessment questionnaires including the short form     health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29     (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical     activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.   "
87391|NCT02142192|"     The primary objective of this study is to evaluate the immunogenicity of natalizumab     (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple     sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of     natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on     relapses and on new magnetic resonance imaging (MRI) lesions.   "
87392|NCT02142179|"     The purpose of this study is to estimate the impact of a curriculum intervention on asthma     knowledge in adolescents of a public school in Salvador-Bahia-Brazil.   "
87393|NCT02142166|"     The aim of this study is to improve the usability of biomarkers for the timely prediction of     new complications following a cerebral hemorrhage, especially in combination with invasive,     functional and local measurements for patients with aneurysmal subarachnoid hemorrhage (SAH).     Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their     immediate and longer-term effectiveness.   "
87394|NCT02142153|"     F901318 is a potent new antifungal agent for the treatment of systemic fungal infections.     This study will test it for the first time in man with the objective of assessing its safety,     tolerability and pharmacokinetic profile.   "
87395|NCT02142140|"     The purpose of the study is to examine how well two types of treatment follow up work     compared to one another:        1. standard community follow up        2. medication monitoring plus tailored case management follow up.      A child's participation will involve 3 months of treatment consisting of medication and     psychological, behavioural, and academic interventions tailored to their individual needs.      Following this treatment, the child will be randomly assigned to receive two years of either     community follow up or medication monitoring plus tailored case management follow up     delivered by the study team. During both types of follow up, at 6 month intervals, the parent     and child will be asked to complete interviews with our study personnel and comprehensive     assessments pertaining to ADHD symptoms and various other areas of functioning.      Parents will also be asked to obtain information from the child's teacher regarding the     child's functioning at 6 month intervals during the school year.   "
87432|NCT02141646|"     This is a randomized controlled trial to contrast an intervention that relies on     well-developed cognitive control systems (Motivational Interviewing; MI) to an intervention     that relies on a more basic response to scheduled reward (Behavioral Skills Training; BST).   "
87396|NCT02142127|"     Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of     drug that is recovered over time via different elimination routes of the body, i.e., whole     blood, blood cells, plasma, urine, feces, and expired air. The ideal case is to be able to     demonstrate a (near) complete recovery (≥95 %) of the administered dose.      A good understanding of the metabolic pathway of the study drug is equally important.     Mass-balance data, together with metabolic profiles in excreta, are used to characterize the     biotransformation pathways of a drug and to help evaluate its drug-drug interaction     potential.      To this purpose, in this study, blood, urine, and feces are collected to investigate the     metabolic profile of GFT505, and plasma and urine are collected to investigate the     non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007. Other     metabolites will be investigated in plasma and urine according to the radioactivity results.     Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated     according to the radioactivity results.   "
87420|NCT02141802|"     Children with cerebral palsy commonly use standing frames to position them to help prevent     contracture and deformity and to help their function. There is a lack of evidence to support     the correct dosage of standing frame use.      The aim of this study is to pilot a randomised controlled trial of the clinical effects of     doubling the duration of standing, using standing frames, in young children who are unable to     walk, who have cerebral palsy or developmental delay.      It will determine whether it is feasable to carry out a multi-centred trial.      The study objectives will be to determine:        1. presence of adverse events        2. recruitment and drop out rate        3. compliance with the intervention        4. feasibility of the randomisation and minimisation process        5. the proportion of the outcome measures taken        6. effect size estimate        7. required study costs        8. effectiveness of blinding procedure   "
87397|NCT02142114|"     The purpose of this study is to determine if a smaller needle size reduces discomfort     suffered by patients both during and following intravitreal injections. It is the     investigators belief that using a smaller size needle will help patients to be less fearful     of intravitreal injections and more amenable to treatment. This study will also evaluate the     effect of needle size on post injection intraocular pressure, to see if smaller needles may     reduce wound leak and increase the intraocular pressure following injection.      The investigators hypothesize that subject eyes injected with the smaller size needle will     result in greater patient comfort both during and after their injection as compared to the     eye injected with the larger needle. The investigators objective is to reduce any discomfort     felt by patients who receive intravitreal injections. The investigators also hypothesize that     the smaller needle will result in higher post injection pressures, and another objective is     to determine if this can affect patient comfort and increase the risk of glaucomatous optic     nerve damage.   "
87398|NCT02142101|"     Gut microbes can influence numerous aspects of human biology. Alterations in the function and     composition of gut microbial flora (gut microbiota ) have been linked to inflammatory bowel     disease, chronic inflammation, dyslipidemia, diabetes mellitus, atopic disorders,     cardiovascular disease, neoplasms, and obesity. However, little is known whether renal     failure alters the composition of gut microbiota and whether an alteration in the gut     microbiota of patients with renal failure impacts on the development of co-morbid conditions     such as accelerated atherosclerosis, abnormal bone mineral metabolism, and chronic     inflammation that are associated with renal failure. Nonetheless, several lines of evidence     suggest that renal failure alters the chemical environment of the intestinal lumen, which     could impose a selective pressure on the growth of certain gut microbes. The investigators     hypothesize that the gut microbiota of patients with renal failure is different from those     without renal failure. To test this hypothesis the investigators are conducting a     cross-sectional study of gut microbiota in patients with different degrees of renal failure     due to polycystic kidney disease (PKD).   "
87399|NCT02142088|"     It has been shown that close control of blood glucose levels in the intensive care unit     patient has benefits for patient morbidity and mortality rates as well as an impact upon     discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose     monitoring system in patients in a surgical ICU environment after cardiac surgery. This study     seeks to evaluate the same equipment being used in a wider range of patients with a range of     underlying conditions who require treatment in medical ICU's. The GlySure device consists of     a sensor that is placed into the patient's blood through a central venous catheter. It     measures blood glucose levels continuously which allows for more rapid control of blood     glucose levels to be achieved as compared to existing methods where blood samples are taken     repeatedly every 15 minutes or so.      The study is designed to show that the sensor can be used for a protracted period of time,     giving accurate results when compared to a reference technique using the i-STAT device. The     investigators intend to show that the device performs safely for the required time within the     ICU.   "
87400|NCT02142075|"     Treatment of infections in critically ill patients remains a significant challenge to     intensivists world-wide with persisting high mortality and morbidity. Compelling evidence     suggests that source control of the pathogen and appropriate antibiotic therapy remain the     most important interventions to improve patients' outcome, the latter including the     administration of a suitable molecule at an optimized dosage regimen.      Daptomycin is the first representative of a new family of antibiotics, the cyclic     lipopeptides. Its bactericidal effect against Gram-positive bacteria, including     meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in     critically ill patients having infections due to resistant Gram positive strains.      Unfortunately, no PK study has been performed in infected critically ill patients without     renal replacement therapy. A vast array of pathophysiological changes can occur in infected     critically ill patients, leading to changes in volume of distribution and clearance of     antibiotics in these patients, which may affect the antibiotic concentration at the target     site.      It is therefore important to better characterize daptomycin PK in infected patients with     various degrees of renal failure in order to define optimal dosing regimens.      This project aims to identify optimal daptomycin administration schemes in critical care     patients with various degrees of renal impairment   "
87401|NCT02142062|"     The purpose of this study is to demonstrate that IVUS identifies more instances of     significant iliac and common femoral vein outflow obstruction than multiplanar venography.No     hypothesis testing is planned.   "
87402|NCT02142049|"     This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and     efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with     relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL). This study is conducted in 2 parts     where treatment will be administered in 3-week (21-day) cycles for 6 cycles. A standard 3+3     design will be employed in Part 1 to determine the maximum tolerated dose (MTD), which will     then define the dose to be used in Part 2.   "
87499|NCT02140905|"     The study has two objectives based on the intended-use measurements and populations described     above. The first objective is to show that relative changes in impedance as measured by the     test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis     (ΔF) for subjects with ESRD and possibly Heart Failure.      The second objective is to demonstrate correlation between ΔSFI and relative changes in     impedance (ΔZ) as measured by the reference device.   "
87407|NCT02141971|"     Non-randomized natural history study involving 12 subjects with Down Syndrome, who are aged     30-60 years old. This study will observe 3 different groups: four non-demented subjects     between ages 30-40 years old, four non-demented subjects between ages 40-50 years old, and     four demented subjects 50-60 years old.      Currently available longitudinal data in DS suggest a high rate of transition to dementia     from the late 40s through the early 50s of these individuals. This, together with the     universal presence of plaques in DS by their mid 40s makes this age range ideal for studying     the development of AD.   "
87408|NCT02141958|"     The purpose of this study is to assess the safety and tolerability of ascending doses of a     novel oral formulation of Fenretinide to adult cystic fibrosis (CF) patients, once-daily for     21 days (treatment cycle). This study will include up to three (3) dose levels with minimum 7     day breaks in between treatment cycles. For each dose level, blood samples will be collected     for exploratory pharmacokinetic (PK) and pharmacodynamic (PD) evaluation.   "
87410|NCT02141932|"     Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA))     it is important to reveal the underlying cause of the disease. In special it is important to     reveal if carotid artery stenosis is present as such a finding will directly influence on     treatment and follow-up.      For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations     is the cornerstone, but computer tomography and magnetic resonance imaging may be better in     some cases. Development of high quality pocket-sized ultrasound scanners has allowed for semi     quantitatively bed-side assessment of the carotid arteries and the heart.      The investigators aim to study the feasibility and reliability of bed-side assessment of the     carotid arteries and the heart by pocket-sized ultrasound scanners and the clinical influence     of this examination when performed by experienced users.      The investigators hypothesize that a significant proportion of this patient population can be     clarified bed-side with no need of further imaging procedures for the assessment of the     carotid arteries and the heart.   "
87411|NCT02141919|"     The goal of this phase II clinical trial is to evaluate the efficacy of the completely     non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy     proven and growing small renal tumors.   "
87412|NCT02141906|"     This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin     for the treatement of patients with unresectable hepatocellular cancer.   "
87413|NCT02141893|"     The aim of this group-randomized trial was to test the effectiveness of a new comprehensive     program, which the investigators called CALMA -plus, in increasing controller medication use     and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention,     plus educational training of physicians and nurses, as well as screening for asthma in     clinics serving Medicaid island Puerto Rican children with asthma. Because the provider     training was expected to have an impact on the entire clinical setting where trained     providers work, as well as the patients using that setting, the investigators randomized     clinic groups rather than individual patients. The investigators compared the CALMA-Plus     intervention to a CALMA-only group, which the investigators expected to obtain the same     benefits as the investigators have previously documented.   "
87414|NCT02141880|"     College drinking associated with sporting events is characterized by excess alcohol, along     with food intake, over the duration of hours has the potential to cause a build up of fat in     the liver. Fatty liver can increase blood glucose concentrations leading to a prediabetes     like state.      The present study will determine how overweight men respond to the over-consumption of     alcohol/food to identify which characteristics might protect some men from fatty liver, while     others might be more susceptible to this condition.      The goal of this work is to determine the direct impact of alcohol/food intake to cause acute     fatty liver through the stimulation of de novo lipogenesis in 20 overweight, healthy men.     Understanding individual susceptibility to alcohol-induced fatty liver will aid in the     development of strategies designed to help people mitigate these risks.      Hypothesis is that 5h excess consumption of alcohol and food will increase liver     triglycerides by 4% or more, in comparison to fasting state.   "
87415|NCT02141867|"     We will conduct a 7 day cohort study of consecutive patients aged 16 years and older     undergoing inpatient noncardiac surgery. Patients will be followed up for a maximum of 30     days. We will follow the original European Surgical Outcomes Study (EuSOS) study design.      The primary outcome is in-hospital mortality. Secondary outcomes include length of stay and     admission to intensive care. Centres across South Africa representing the public service will     recruit patients. This study will run from 19 May 2014 to 26 May 2014.   "
87416|NCT02141854|"     The primary objective of this study was to evaluate the efficacy of fluticasone propionate     (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS)     MDPI when administered over 12 weeks in patients 12 years of age and older with persistent     asthma.   "
87417|NCT02141841|"     This study was performed in 131 adult patients undergoing transurethral, urological or lower     limb surgery under combined spinal and epidural anesthesia. Patients were stratified     according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component of     the anesthetic was established by bolus administration of up-and-down doses of 0.75% plain     bupivacaine, determined by Dixon's method. The degree of motor block after intrathecal     administration of each concentration was evaluated by the modified Bromage and Hip motor     function score. The EC50 were estimated from the up-and-down sequences using the method of     Dixon and Massey and logistic regression. Other endpoints were included on the basis of     sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.   "
87418|NCT02141828|"     A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)     harbor rearrangements of the MLL gene, which are detected either by cytogenetic or     fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L     plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule     that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of     patients with MLL-rearranged leukemias.   "
87419|NCT02141815|"     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,     uremic retention solutes. Evidence is mounting that the colonic microbiota contributes     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are     among the most extensively studied gut microbial metabolites, and are associated with     cardiovascular disease, overall mortality and chronic kidney disease progression. The most     important regulator of colonic bacterial metabolism is nutrient availability and especially     the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake     of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides     (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing     effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in     general, and AXOS more specifically, can influence intestinal generation of microbial     metabolites in predialysis patients has not been studied to date. An interventional study     with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease     intestinal generation and serum concentrations of microbial metabolites in patients with CKD     not yet on dialysis.   "
88697|NCT02125110|"     This project aims at evaluating the consequences of prenatal exposure to neurotoxicants     (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to     12 years.   "
87421|NCT02141789|"     Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders     and/or depression. Anxiety and depression influence the course and treatment of alcohol     dependence and are a major risk factor for alcohol relapse within the first three months     after detoxification. Therefore, there is need for combined treatment (integrated therapy) of     alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression. Until     today, there are no systematic outpatient treatment offers for this special group of patients     in Germany. In this study we want to investigate if integrated outpatient cognitive     behavioral therapy can prevent and decrease alcohol relapse within the first three months     after detoxification. Therefore we hypothesize that immediate start of integrated outpatient     psychotherapy will reduce relapse variables compared to treatment as usual which is     characterized by non-immediate start of therapy due to the required application for insurance     coverage.   "
87422|NCT02141776|"     Major depressive disorder (MDD) is a significant public health problem. Existing treatment     modalities are not always sufficient to alleviate this disorder. Treatment refractoriness is     a common clinical problem. Transcranial direct current stimulation (t-DCS), a non-invasive     brain stimulation technique, has been shown to be effective in alleviating depressive     symptoms in preliminary studies. There is need to explore the role of t-DCS in     Treatment-resistant depression (TRD). Therefore, the investigators aim to undertake this     exploratory study.      Aim:      Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks (20 week     days) with sham stimulation in alleviating depressive symptoms in patients with TRD.      Methodology: Patients who seek treatment in our treatment resistant depression clinic and who     have failed to respond to treatment with two antidepressant medications will be offered to     enroll in this study. The aim is to study 20 patients who meet the Diagnostic and Statistical     Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD between the ages of 21-65     years. Those subjects that receive sham stimulation will be offered to have active t-DCS     stimulation for additional 3 weeks to get any benefit that they may have otherwise missed by     being in the sham stimulation group.      Results and Conclusions: The investigators will compare the mean baseline and end of     treatment Montgomery Asberg depression rating scale between the two groups. The investigators     will compare the change in mean depression scores between the baseline and end of treatment     in those receiving active t-DCS for a total of 7 weeks duration. This study is innovative and     of significance in exploring the role of this novel, easy to administer, safe and cost     effective treatment modality.   "
87423|NCT02141763|"     A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body     distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the     treatment group.   "
87424|NCT02141750|"     The Registry pretends to identify stratification, diagnosis and treatment approaches in     patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals to     optimize resources and identify strategies to improve health care quality through the     creation of clinical guidelines that serve for unify management and treatment methods with     adherence to international guidelines which include suggestions for treatment and medication.   "
87425|NCT02141737|"     To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with     etomidate during general anesthesia in elderly patients   "
87426|NCT02141724|"     A retrospective study with the patients having a positioning consultation at hospital,     between 2009 and 2014. In every neuromuscular disorder, the investigators describe the     population seen in consultation, the aim of consultation, the postural problem observed in     wheelchair, pain when sitting in wheelchair, and pressure ulcer.   "
87427|NCT02141711|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind,     placebo controlled, sequential panel, multiple-dose schedule.   "
87428|NCT02141698|"     The primary purpose of this study was to evaluate the safety, tolerability, and     pharmacokinetics of TAK-438 following single or multiple doses of TAK-438 in healthy Western     men, to investigate the effect of food on the pharmacokinetics of TAK-438, and to compare the     TAK-438 pharmacokinetics of Western with Japanese men.   "
87429|NCT02141685|"     The purpose of this research study protocol is to collect imaging data on embryos followed to     blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic     Hybridization (aCGH) results and ongoing pregnancy rates.   "
87433|NCT02141633|"     The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in     airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime     non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2)     compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week     treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic     parameters. With this protocol the Investigators will test the hypotheses that a) there is a     correlation between airway and pulmonary vascular endothelial function within the current     smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular     endothelial function in the current smoker group.   "
87434|NCT02141620|"     This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine     as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study     will be conducted in which the subjective, physiological and reinforcing effects of cocaine     are evaluated during maintenance on placebo and n-acetylcysteine.   "
87435|NCT02141607|"     The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic     instability, systemic inflammatory response syndrome and multiorgan failure has been     extensively investigated, but there is no consensus on the trigger mechanisms of tissue     injury at the molecular level.      Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they are     unable to act at the beginning of the cascade, because of the lack of a model explaining     the molecular basis of shock induced tissue injury and ensuing organ damage.      The present observational study is aimed at identifying the molecular triggers of acute heart     failure (HF) induced by shock and to identify inflammatory mediators and markers that are     activated in shock, with a particular emphasis on the role of uncontrolled proteolytic     activity.   "
87436|NCT02141594|"     Spectrailis optical coherence tomography has come with a new posterior pole asymmetry     analysis for glaucoma diagnosis. The aim of the investigators study was to assess its     applicability in diagnosing early glaucoma patients.   "
87439|NCT02141555|"     First trimester miscarriages are common. When the failed pregnancy does not pass     spontaneously on its own, it is called a missed abortion. There are several ways in which     missed abortions are managed, one of which involves administering a medication called     misoprostol which causes uterine contractions inducing expulsion of the failed pregnancy.     Misoprostol can be administered in multiple ways but has been traditionally inserted     vaginally when used for management of missed abortions. Some studies have shown that some     women are not comfortable with vaginal insertion of misoprostol and prefer oral     administration. Buccal misoprostol is a way of administering misoprostol by having the     patients insert the tablets of misoprostol between their gum and cheek, letting it dissolve     for 30 minutes, then swallowing the remaining remnants. Buccal misoprostol is used safely in     medical abortion. In fact a study by Fjerstad et al (2009), found a decrease in infection     rate for medical abortion when misoprostol administration was switched from vaginal to buccal     route combined with routine administration of doxycycline. The efficacy of using buccal     misoprostol to treat missed abortions has not been studied previously to the investigators'     knowledge. In this pilot study, investigators aim to test the hypotheses that buccal     misoprostol is equally effective as vaginal misoprostol in the medical management of early     pregnancy loss. As secondary outcomes, investigators suspect that buccal misoprostol may be     associated with higher rates of gastrointestinal side effect but that patient satisfaction     will remain equally as high for buccal misoprostol as for vaginal misoprostol.   "
87440|NCT02141542|"     This is an open label, phase I trial, testing the combination of Tremelimumab and MEDI3617 in     patients with metastatic melanoma.   "
87441|NCT02141529|"     The purpose of this study is to determine whether bipolar intraarticular pulsed     radiofrequency method has a superiority to unipolar mode in the treatment of chronic knee     pain.   "
87442|NCT02141516|"     The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered     to subjects from 2 to 17 years of age with increased risk of meningococcal disease because     either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction.     A group of healthy age-matched subjects will be enrolled to serve as a descriptive control     for immunogenicity and safety.   "
87443|NCT02141503|"     Background:      - Alpha-mannosidosis is a rare inherited disorder. It causes problems in many organs and     tissues of the body. It can occur in children and adults. Because there is no treatment for     this disease, researchers want to find out more about it.      Objective:      - To learn more about Alpha-mannosidosis.      Eligibility:      - People ages 5-60 with Alpha-mannosidosis.      Design:        -  Participants will be recruited from patient support organizations and medical genetics          clinics.        -  Participants will have 3 study visits, about once a year. A final evaluation will be          made after 3 years.        -  Participants will have a medical history and a physical exam.        -  Blood samples and a urine sample will be collected.        -  Cerebrospinal fluid will be collected. A small area of the lower back will be numbed          with medicine. A thin needle will be inserted between the spine bones. About 2          tablespoons of spinal fluid will be removed.        -  Brain magnetic resonance spectroscopy (MRS) scans will be done at each visit. MRS uses a          strong magnetic field and radio waves to take pictures of chemicals in the brain with a          scanner. The participant will lie on a table that can slide in and out of the cylinder.          While in the scanner the participant will hear loud knocking noises. They will get          earplugs or earmuffs to muffle the sound. Medicines might be used to keep the          participant asleep during the MRS.        -  Participants will have a skin biopsy at the first visit only. A small area of the          participant s skin will be numbed. A small circle of skin will be removed with a biopsy          tool.   "
87444|NCT02141490|"     Background:      People with prostate, bladder, or kidney cancer often have their cancer spread (metastasize)     to lymph nodes. It is important for your doctor to know if this has occurred but currently it     can be hard to determine if this has occurred on standard imaging studies like CT or MRI.     This study uses an agent called Ferumoxytol to identify lymph nodes that might be involved by     cancer.      Objective:      - To see how well Ferumoxytol can detect lymph node metastases in patients with prostate,     bladder, or kidney cancer.      Eligibility:      -Adults over age 18 with prostate, bladder, or kidney cancer with lymph node involvement.      Design:        -  Participants will be screened with a medical history.        -  Participants will have blood drawn and a physical exam. Their vital signs will be          measured. They will answer questions about their health and current medications.        -  Participants should not have a history of iron overload or have an allergy to          Ferumoxytol.        -  Participants will have a magnetic resonance imaging (MRI) scan. The scanner is a metal          cylinder with a strong magnetic field. Participants will lie on a table that slides in          and out of the scanner. They will have a standard sensor, known as a coil, wrapped          around their abdomen to improve the scan. This is like a small blanket with wiring          inside. Participants will need to lie still on the scanning table for about 1 hour.        -  Participants will have an ultrasound. This uses harmless sound waves to provide pictures          of organs or tissues inside the body.        -  Participants will receive an injection of Ferumoxytol through an intravenous line. A          very thin plastic tube will be inserted into a vein in order to inject the agent.        -  Participants will have another MRI and ultrasound 24 and 48 hours after injection.        -  The study will follow participants medical course for at least 1 year.   "
87445|NCT02141477|"     This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to     test the safety of the combination of omacetaxine and decitabine and to find the best dose to     give to future patients. The goal of Phase 2 of the study is to learn if this dose can help     to control AML and/or MDS. The safety will then continue to be studied.   "
87446|NCT02141464|"     Ivacaftor is a novel, FDA approved new therapy that addresses Cystic fibrosis transmembrane     conductance regulator (CFTR) dysfunctions in subjects with Cystic fibrosis (CF) and gating     mutations.      The primary aim is to determine the mechanism(s) for weight gain in participants whom     Ivacaftor treatment was initiated based on clinical indications by CF Care Team. This     longitudinal study will assess in detail energy expenditure, weight gain, body composition,     and lung function in 24 subjects ≥6 years old with CF with a gating mutation before treatment     and after three months treatment with Ivacaftor. All subjects will be seen at the Children's     Hospital of Philadelphia's Clinical Translational Research Center.   "
87447|NCT02141451|"     This is a single institution phase I/II study using an ADAM17 inhibitor (INCB7839) with     rituximab as consolidation therapy after an autologous hematopoietic cell transplant (HCT)     for patients with diffuse large B cell lymphoma (DLBCL). The study consists of two phases.     The dose finding phase is a modified version of a phase I trial and the extended phase is a     modified version of a phase II trial.   "
87448|NCT02141438|"     Observational study in the routine clinical practice setting to evaluate the short and long     term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients     and to evaluate the risk of developing second primary cancers.   "
87452|NCT02141386|"     Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS).     The primary objective of this study is to evaluate the efficacy for treating MS-associated     cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive     remediation treatment (PACR) compared to a computer-based control. This novel cognitive     remediation approach has led to striking improvements in cognitive functioning in other     disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been     applied to individuals with MS. The investigators will enroll 136 MS participants who will be     randomized in a 2:1 pattern to complete either the treatment or control condition for 60     hours across a 12-week treatment period. Both the treatment and control conditions will be     accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will     include program compliance, performance on study tasks and neuropsychological measures,     quality of life and functional status. Given the success of this program with other disorders     and strong preliminary data from our feasibility study, the investigators believe PACR is an     exciting untapped opportunity to improve cognition in individuals with MS.   "
87453|NCT02141373|"     Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary     dissection in breast cancer patients.   "
87454|NCT02141360|"     This hypothesis-generating feasibility study compares mTBI Patients and Controls using     advanced MRI Applications.   "
87455|NCT02141347|"     A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and     Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab     in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when     given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese     Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma   "
87456|NCT02140294|"     Patient found to be malnourished after the nutritional evaluation would be randomized in the     two groups of the study. The control group would receive standard nutritional counseling from     a trained dietician where as those in the intervention group would be given 120 gm of a     polymeric nutritional supplement providing around 500 Kcal per day over and above the     standard nutritional counseling from a trained dietician. Both the groups would receive     standard medical treatment. The polymeric nutrient supplement would be taken by the patients     in this arm for a period of 6 months.   "
87457|NCT02140281|"     A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of     Cefadroxil   "
87458|NCT02140268|"     A Study to Evaluate the Effects of oral repeated doses of AZD1722 on the Pharmacokinetics of     Oral Midazolam in Healthy Volunteers   "
87459|NCT02140255|"     IMPAACT P1115 will explore the effects of early intensive antiretroviral therapy (ART) on     achieving HIV remission (HIV RNA below the limit of detection of the assay) among     HIV-infected infants.   "
88226|NCT02131246|"     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the     investigated drug on the body) properties of faster-acting insulin aspart in subjects with     Type 1 diabetes.   "
87460|NCT02140242|"     The proposed trial will address two clinically important questions for younger patients with     newly diagnosed acute myeloid leukemia (AML): the optimal dose of daunorubicin in induction     therapy and the necessity of a second induction cycle in patients with a good response after     the first induction. The primary endpoint is the rate of good responders. Secondary outcomes     will be relapse-free survival, overall survival and minimal residual disease kinetics.     Patients will be recruited in about 40 treatment centers of the Study Alliance Leukemia study     group over a period of 40 months. The results will be of great clinical relevance: First, the     study could facilitate the establishment or confirmation of the optimal daunorubicin dose.   "
87461|NCT02140229|"     Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks     to a large choice of therapies, early treatment and tight control (30% relapse).      Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve     the prognosis of RA in remission by increasing the duration of sustained remission and by     preventing radiographic structural progression.      The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained     clinical remission.   "
87462|NCT02140216|"     An increasing number of publications have demonstrated that homologous (allogeneic) blood     transfusion impairs outcome in cancer and non-cancer patients. Leukocyte depletion of blood     products cannot solve these problems, despite improved quality of red cells; a recent study     demonstrated deteriorated outcome of cancer patients with elective colon surgery and     transfusion of leukocyte depleted allogeneic blood.   "
87463|NCT02140203|"     Metabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing     central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of     MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has been     a useful tool in prognosing the development of cardiovascular disease and diabetes mellitus.     Importantly, interventions applied at the pre-pathologic stage with MetS would be of great     clinical and health significance in achieving better preventive and therapeutic outcomes.     Yoga, a mind-body exercise, has been suggested to have beneficial effects on dyslipidemia,     hypertension and diabetes. A pilot study has demonstrated the trends in the improvement of     metabolic parameters in middle-aged adults with MetS but the findings are inconclusive     because of the small sample size and brief yoga follow-up period (i.e., 2-month). In addition     to the needs of a better designed randomized controlled trial in studying the beneficial     effect of yoga in controlling MetS in middle-aged individuals, the investigation on yoga and     MetS in elderly population has been lacking. This is important as the potential use of yoga     as lifestyle modification in elderly individuals with MetS will result in significant     reduction of the prevalence of cardiovascular disease and diabetes. Thus, this study aims to     examine the efficacy of yoga exercise in improving metabolic abnormalities in middle-aged and     older adults with MetS. In addition to elderly, middle-aged adults are included in the     present investigation because of the idea that cardiovascular diseases and diabetes with     aging can be mostly prevented by intervention at the middle-age. A randomized controlled     trial with repeated measure design will be conducted to examine the effect of 1-year regular     yoga training on the MetS parameters in middle-aged and older individuals who are 30-60 and     60-80 years of age, respectively. Primary outcome measures include waist circumference,     systolic/diastolic blood pressure, blood glucose, triglyceride, and lipid cholesterol profile     whereas secondary outcome measures include self-reported stress and depression levels. This     study is anticipated to provide valuable information in exploring the therapeutic role of     yoga in managing MetS. As yoga exercise is an economical regimen which can be easily and     readily applied to large scale of target population, it is of hope to be practically useful     to relieve the burden on cardiovascular disease and diabetes by introducing yoga lifestyle to     the management of MetS.   "
88570|NCT02126761|"     In this study, the safety and immunogenicity of the current formulation of aTIV will be     compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be     doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in     independently-living elderly subjects ≥ 65 years of age.   "
87464|NCT02140177|"     Background:      - Suicide is the 10th leading cause of death for U.S. adults. Medically ill people are at an     increased risk of suicide. Most people who have killed themselves went to a healthcare     provider within 3 months of their death. More and more, hospitals are being asked to assess     people for signs of suicide risk so that they can get the help they need. If nurses and     doctors can find out who is at risk they can make sure these people get help in the hospital.      The asQ em (Ask Suicide-Screening Questions to Everyone in Medical Settings) is a brief     questionnaire. It was created to detect suicidal thoughts and behaviors in hospitalized     people. Researchers would like to further develop this tool and figure out which are the best     questions to ask patients.      Objective:      - To determine the best questions for healthcare providers to ask people with medical     illnesses to see if they are having suicidal thoughts or planning to hurt themselves.      Eligibility:      - NIH Clinical Center patients over age 18.      Design:        -  Participants will be asked questions about how they have been feeling in the past few          weeks. They will be asked questions about depression, anxiety, and suicidal thoughts and          behaviors. They also will be asked some background questions.        -  It will take approximately 15 to 30 minutes to answer the questions.   "
87465|NCT02140164|"     Background:      - Some people with retinitis pigmentosa (RP) have macular edema (swelling) in the central     retina. This can cause decreased central vision. The cause of macular edema is unknown, but     may involve inflammation. The drug minocycline might help prevent inflammation and therefore     might help treat macular edema and improve central visual function .      Objectives:      - To see if minocycline helps people with RP and macular edema.      Eligibility:      - People 12 years and older with RP who have macular edema in at least on eye.      Design:        -  Participants will be screened with medical and eye disease history. They will have an          eye exam and blood tests. One eye with macular edema will be the study eye. If both eyes          are affected, one will be designated the study eye.        -  Participants will visit the clinic at least 9 times over at least 14 months. The first 3          study visits will be monthly, then every 2 months.        -  Participants will start taking minocycline after visit 3. They will take 1 pill twice          daily for at least 1 year.        -  Participants will keep a medicine diary and bring it to each visit with their pill          bottle and unused pills.      At each study visit, participants will have some or all of the following tests:        -  eye and thyroid exams        -  blood and pregnancy tests        -  microperimetry: participants will press a button when they see a light on a computer          screen        -  visual field measurement: participants will look at spots on a white screen to test side          vision        -  electroretinogram: A person will be dark adapted by sitting in the dark for 30 minutes.          After the placement of numbing eye drops, special contact lenses will be placed . The          participant will watch flashing lights and recordings will be made.   "
87466|NCT02140151|"     This study will determine whether quarterly injections of Ranibizumab may prevent eyes with     dry age-related macular degeneration from progressing to wet age-related macular degeneration     (AMD).   "
87467|NCT02141321|"     The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic     analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered     before only by cesarean section.   "
91030|NCT02094573|"     The purpose of this study is to evaluate the efficacy and safety of two different dosing     regimens of brigatinib (AP26113) in participants with ALK-positive locally advanced or     metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with     crizotinib.   "
87468|NCT02141308|"     This study will evaluate the total blood flow in the retina and choroid (structures in the     back of the eye) by Doppler optical coherence tomography (OCT) and OCT angiography.     Angiography is mapping of the blood vessels.      The purpose of measuring blood flow in the retina and choroid is to 1.) determine if rare     diseases in these structures causes a change in blood flow compared to healthy eyes and 2.)     find out if areas of changed blood flow line up with areas of damage that appear on     conventional testing.   "
87469|NCT02141295|"     This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab     to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic     acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in     participants with previously untreated metastatic colorectal cancer (mCRC). The study     consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized,     parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants     will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm     the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will     be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 +     bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each     14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either     bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic     acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression,     unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.   "
87470|NCT02141282|"     This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and     safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL after B-cell     receptor signaling pathway inhibitors (BCR PI) treatment.   "
87471|NCT02141269|"     A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with     limited data available comparing the effectiveness of this device as a screening tool when     compared to traditional transthoracic echocardiography (TTE).      The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in     detecting cardiac pathology in a both an inpatient and outpatient clinical setting as     compared to a comprehensive TTE evaluation.   "
87472|NCT02141256|"     The objective of this study is to investigate whether a protein-enriched daily menu is     acceptable and effective in increasing protein intake in elderly in a residential care home     up to an intake of 1,2 gram/ kg body weight per day.      The investigators hypothesise that when elderly eat 2 slices of bread, 1 portion of juice and     1 portion of soup each day, the protein intake can be increased by at least 20 grams/day. On     average this can lead to an intake of 1,2 gram/ kg body weight per day.   "
87473|NCT02141243|"     We are proposing to conduct a randomized, controlled trial of newborns in the maternal infant     care areas at Tampa General Hospital. Participants who are determined eligible for the study     (classified to have ankyloglossia via the HATLFF and either a Class III or IV maxillary     labial frenum) will be randomly assigned to one of two groups: Group A or Group B. Group A     will receive a sham procedure for intervention #1 and a lingual frenotomy procedure for     intervention #2. Group B will receive a lingual frenotomy procedure for intervention #1 and a     sham procedure for intervention #2. Newborns that continue to have difficulty with     breastfeeding after both interventions will undergo intervention #3, a labial frenotomy, and     breastfeeding will be monitored afterwards.   "
87474|NCT02141230|"     Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey     1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli®     (orlistat 60 mg) were recommended. The main finding from RMP survey 1 was that a large     proportion of Alli® users had a body mass index (BMI) less than (<)28 kg/m2 . (Note: the     European indication for Alli® is adults 18 years and older with a BMI<28 kg/m2.) The     proportion of respondents overall who reported possible contraindications to Alli® use was     relatively low. The following changes to the pack labeling were agreed and have been     implemented: : (1) a statement, highlighting the product is only for those with a BMI of 28     or above was added to the front of the pack; (2) wording of the BMI statement on the back of     the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the     statement that Alli® is not for use by those under 18 years of age was modified for clarity.     In addition, a pharmacy reminder card was made available to retail pharmacists to improve     awareness of the prescribing information for Alli®. The survey will assess whether compliance     with the authorized indication and contraindications among purchasers of Alli® has been     improved after one year of marketing the revised pack labeling.   "
87475|NCT02141217|"     In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of     odontogenic infection. Therefore, this study is designed to generate data to support its use     by demonstrating efficacy, safety and tolerability in comparison with clindamycin in subjects     with acute odontogenic infections with or without abscess. This will be a two-arm, parallel,     comparative, observer blind, randomised study to assess efficacy, safety and tolerability of     amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg)     administered for 5-7 days in subjects with acute odontogenic infections with or without     abscess. The study will be performed in adult subjects both male and female ≥18 years of age     who present with acute odontogenic infections. A total of 472 subjects will be randomized in     1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of the study will     be at least 5 days or maximum 7 days depending upon the treatment response. Subjects will be     assessed on Day 5 and if Investigator feels the need of continuing the treatment at Day 5     then treatment will be continued till Day 7. For subjects who do not show treatment response     on Day 5, assessments will be performed on Day 7.   "
87476|NCT02141204|"     The purpose of this study is to evaluate and compare immunogenicity, reactogenicity and     safety of two formulations (liquid vs. lyophilised) of GSK Biologicals' HRV vaccine when     administered as two doses in healthy infants aged ≥ 6 weeks.   "
87477|NCT02141191|"     The primary objective of this study is to determine whether a single overnight, eight-hour     administration of a 7% NaCl solution delivered by the Parion Sciences transnasal Pulmonary     Aerosol Delivery (tPAD) device has a significant effect on mucociliary clearance in subjects     with cystic fibrosis, as compared to no treatment. This study will be conducted at the     University of Pittsburgh Medical Center.   "
87478|NCT02141178|"     Carpal tunnel syndrome is one of the most common surgeries performed per year in the United     States, accounting for over 600,000 surgeries. The procedure is commonly performed under     light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been     used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a     liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72     hours post-operatively. By decreasing post-operative pain through the use of a long-acting     local anesthetic, the use of narcotic pain medications may be decreased and patient     satisfaction scores may increase.      The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine     with respect to post-operative pain control, narcotic usage, and patient satisfaction after     carpal tunnel release.   "
87479|NCT02141165|"     Primary objectives: To determine the efficacy and cost-effectiveness of a management program     for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or     specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be     made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist     healthcare arm will use polysomnography (PSG) in a hospital. Patients with an     intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth     scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.      Secondary objectives: efficacy of the two SAHS management programs according to the following     secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical     wellbeing scale, b) adherence to and compliance with the treatment.   "
87480|NCT02141152|"     The next generation of personalized medical treatment according to the type of personal     genetic information are evolving rapidly. The genome analysis needs systematic infra and     database based on personal genetic information Therefore, a big data of genome-clinical     information is important.      To determine the feasibility of the use of tumor's molecular profiling and targeted therapies     in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of     response and overall survival) of patients with advanced cancer, the investigators are going     to take a fresh tissue of patients and process molecular profiling and receive molecular     profile directed treatments.   "
87481|NCT02141139|"     It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent     the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory     drug) has been suggested.However, there was no consistent results. surgery is main cause of     inflammation for cancer patients. Therefore, we want to know the association between     prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.   "
87482|NCT02141126|"     The primary aim of this research is to evaluate changes in lower limb strength and physical     function following six weeks of resistance training and routine physiotherapy versus a     control group of routine physiotherapy only in an older inpatient population.   "
87483|NCT02141113|"     This is considered an investigator-initiated clinical research trial, which means that your     study doctor is researching a particular medication (in this case a medication that is     currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication     is guanfacine hydrochloride.      The hypothesis is that this medication could be used in adults with Attention     Deficit/Hyperactivity Disorder who have not received satisfactory results with their current     stimulant ADHD medication. The study drug is investigational for use in adults.     Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA)     for use in adults.   "
87484|NCT02141100|"     The purpose of this phase 1-2 study is to explore the applicability of supplementing standard     methotrexate/6-mercaptopurine (MTX/6MP) maintenance therapy of children with non-Hodgkin     lymphoma with 6-thioguanine (6TG).      The investigators hypothesize that addition of 6TG to 6MP-based maintenance therapy of     patients with high TPMT activity will mimic the more favourable thiopurine metabolism of     patients with low TPMT activity and ultimately reduce relapse rates.   "
87485|NCT02141087|"     This is an open label multi-center program to allow patients in the US with IPF access to     treatment with pirfenidone.   "
87486|NCT02141074|"     This trial is conducted globally. The aim of the trial is to investigate the safety and     efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.   "
87487|NCT02141061|"     This study is a double-blind crossover study in female healthy volunteers to compare the     pharmacokinetics and safety of a single dose each of two different formulations of Proellex     for oral administration. Each formulation will be designated as either Treatment A or     Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to     receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day     washout period subjects will receive the alternative treatment. On the day of each treatment     subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment     at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after     administration of study drug.   "
87488|NCT02141048|"     The purpose of this study is to determine whether the Parent Centre's Positive Parenting     Skills Training (PPST), a parenting programme being delivered in South Africa, is effective     in improving parenting, and child behaviour related outcomes.   "
87489|NCT02141035|"     Study Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe     carpal tunnel syndrome.      Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In     severe cases, nerve regeneration and functional recovery are incomplete even with surgery.     The goal of this pilot project is to test a potentially promising medication,     acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled     study design. Along with surgery, those in the treatment group will also receive ALCAR while     the other half in the control group will be given placebo. To gauge the effects of ALCAR, we     will compare motor and sensory nerve growth as well as functional outcomes. The data from     this study will provide crucial information when designing a full scale clinical trial. If     successful, this will represent an important first step in finding a novel treatment to     improve functional outcomes in patients with severe CTS.   "
87490|NCT02141022|"     This study is investigating the efficacy of computer-based cognitive exercises as a means of     cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease     modifying pharmacotherapy Gileyna.   "
87491|NCT02141009|"     Community acquired pneumonia (CAP) is an important health problem with significant morbidity,     mortality and cost. The most identified pathogen in CAP is Streptococcus pneumoniae. This was     also the causative agent most frequently found in the Ovidius and Triple-P study, two     consecutive clinical trials initiated by the St. Antonius Hospital Nieuwegein. Diagnosis of     pneumococcal pneumonia can be based on positive blood cultures, sputum cultures, urine     antigen testing or a serotype specific antibody response. When pneumococcal pneumonia is     diagnosed by a positive culture, a matching serotype specific antibody response is expected.     However not all patients in the Ovidius and Triple-P study with a culture proven pneumococcal     pneumonia showed an antibody response against the infecting pneumococcal serotype. Patients     who survived pneumococcal pneumonia are considered as a high-risk population for pneumococcal     disease in the future. Possibly these patients have an impaired immune response against S.     pneumoniae. In this study, pneumococcal vaccination of patients with S. pneumoniae CAP in the     past enables investigating their immune response after vaccination compared to patients with     CAP due another causative agent. Furthermore this study provides information to determine if     there is a difference in vaccination response between pneumococcal pneumonia patients who had     a culture matching serotype specific antibody response and between pneumococcal pneumonia     patients who failed to elicit this response previously. Possibly these latter patients had a     temporarily low titre due to the infection but another explanation is that there might be a     structurally impaired immune response against S. pneumoniae or certain serotypes.   "
87492|NCT02140996|"     In epithelial cancer, MUC-1(mucin-1) overexpression is thought to disrupt E-cadherin     function, leading to anchorage-independent tumor cell growth and metastases. Elevated levels     of MUC-1 expression have been found in patients with epithelial cancers of breast, ovarian,     colon and lung. Furthermore, overexpression of MUC-1 is independently correlated with adverse     clinical phenotypes, metastases and resistance to chemotherapy. In animal models, suppressing     the expression of MUC-1 reduces the rates of growth and metastasis and increases the     sensitivity of the cancer to chemotherapy-induced cell death.      In this study, an adenoviral Ad-sig-hMUC-1/ecdCD40L vector encoding a fusion protein in which     the hMUC-1 epithelial antigen is attached to the CD40L (CD40 ligand). The preclinical results     have also shown that two subcutaneous Ad-sig-hMUC-1/ecdCD40L vector injections can induce     immunity through activation of dendritic cells and promotion of antigen specific B cells or     antigen specific CD8 effector T cells which suppresses the growth of hMUC-1 tumor cells in     100% of the vaccinated mice without Interleukin (IL) 2 stimulation being required, this     suggests that the Ad-sig-hMUC-1/ecdCD40L vector prime-hMUC-1/ecdCD40L protein boost has the     potential to be an effective vaccine in epithelial tumors. Therefore, the safety and     tolerability of the Ad-sig-hMUC-1/ecdCD40L vector vaccine will be tested in this phase I     non-randomized open label dose escalation trial for men or women with metastatic or recurrent     epithelial cancers of the lung, breast, ovary, prostate and colon.   "
87493|NCT02140983|"     The purpose of this study is to evaluate the effects of liraglutide on the memory and     attention of people with insulin resistance. Liraglutide is a medication that makes the body     more sensitive to insulin, and therefore may allow it to manage sugar more effectively.      The investigators are looking specifically at a region of the brain that is associated with     memory and attention, called the hippocampus, in order to see whether treatment this     treatment will change performance on memory and attention tasks. The investigators are also     taking an MRI of the brain to see whether there are changes to the size and shape of the     hippocampus after treatment.      All subjects in this study will be 50-70 years old and have pre- diabetes. Half of all     subjects will have a family history of dementia, while the other half will not.   "
87494|NCT02140970|"     This study plans to learn more about whether ibuprofen can reduce pain after removal of a     ureteral stent more than a placebo. Some patients experience pain after removal of a ureteral     stent. The investigators plan to learn how often this occurs and whether it can be prevented.      The investigators hypothesize that children who have a temporary, indwelling ureteral stent     will experience a significantly less post-operative pain if given a non-steroidal     anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo.     The investigators hypothesize that the incidence of severe post-stent removal pain is similar     to an adult population.   "
87495|NCT02140957|"     Observational studies support an association between bottle feeding beyond 15 to 18 months of     age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency,     behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic     households, choose to feed their children by bottle much beyond this age. Recognizing the     need for further educational interventions for bottle feeding, the TARGet Kids! Research     Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9     month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its     effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal     was to determine whether an office-based, educational intervention for parents of 9-month-old     children could reduce bottle use and iron depletion at 2 years of age.   "
87496|NCT02140944|"     IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older,     who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer,     hematopoietic disease, or other underlying disease.   "
87497|NCT02140931|"     A randomized, double-blind placebo controlled study to determine the safety and efficacy of     Angiogenic Cell Precursors (ACPs) in relieving symptoms of Critical Limb Ischemia in patients     treated with standard of care and with no surgical revascularization option. It is assumed     that the ACP-treated group will have a lower amputation and death rate as compared to the     placebo group. Other hemodynamic, imaging and clinical parameters will also be compared     between the two groups. Quality of life assessments will also be performed.   "
87498|NCT02140918|"     Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in     survival in septic shock patients with relative adrenal insufficiency. However, the utility     of low doses of steroids and in particular of mineralocorticoids in septic shock is still     discussed.      The purpose of the investigators study is to investigate the effects of 3 increasing doses of     fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best     pressor response to phenylephrine in healthy volunteers, and simultaneously assess their     respective hemodynamic and biological effects.   "
87500|NCT02140892|"     One of the main goals of the respiratory physical therapy is to help people who are suffering     from accumulating of secretions in their airways and lungs.      Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute     Exacerbation of their medical condition.      Those patients usually get only the standard medical care during the acute phase and don't     get respiratory physical therapy treatment.      The study's main aim is to investigate if respiratory physical therapy treatment in addition     to standard medical care during the acute phase, can improve the respiratory and medical     condition and reduce hospitalization stay.      In order to do so we will compare three groups of COPD patients during acute exacerbation;     two groups will get one out of two respiratory physical therapy techniques; manually or     Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third     group will get standard medical care alone.   "
87501|NCT02140879|"     This research study will examine how diet during pregnancy can benefit pregnancy and     pregnancy outcome, such as your baby's weight. More specifically, the investigators will     study the effects of two different food oils/fats that are commonly consumed to determine if     one is more effective in limiting maternal inflammation during pregnancy. You are being asked     to take part in this study because it will help us update and make the best dietary     recommendations for pregnant women and women of child bearing ages.   "
87502|NCT02140866|"     The study examines whether hand exercise therapy as an add on to a compensatory intervention     program focused on joint protection, assistive devices and alternative methods of doing will     improve the performance of ADL tasks requiring hand function in patients with rheumatoid     arthritis (RA).   "
87503|NCT02140853|"     Objective        1. To evaluate the impact of MDR pathogen on prognosis and therapy cost;        2. To compare the efficacy of different antibiotics in treatment of infection caused by MDR          pathogens;        3. To evaluate the risk factors of MDR pathogens infection;        4. To evaluate the distribution and characteristics of MDR pathogens;        5. To investigate the proportion of MDR isolates to construct systematic database.   "
87504|NCT02140840|"     The purpose of this study is to evaluate the overall response rate of Trametinib when     administered orally to patients with relapsed or refractory multiple myeloma   "
87522|NCT02140606|"     To investigate safety, tolerability of cafusertib combination with low dose cytarabine     (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for     conventional or intensive treatment. The dose of cafusertib will be escalated to determine     the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in     combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics     and preliminary efficacy of cafusertib will be observed in AML patients. To determine the     recommended dosage regimen for phase II.   "
93975|NCT02056041|"     Selection criteria for safe hepatectomy for HCC are not well established. The aim of this     study was the validation of the selection criteria for safe hepatectomy for hepatocellular     carcinoma.   "
87505|NCT02140827|"     Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of     colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing     reduces the cecal intubation rate, and the polyp detection rate (PDR). It also increases     costs, mostly due to repeated procedures. The quality of bowel cleansing has remained     suboptimal even though numerous different products and regimens have been tested and compared     in no fewer than six meta-analyses. Therefore, a completely different approach to improve     bowel cleansing is welcome.      Here the investigators assume that instant messaging program (Wechat) delivery the detail and     FAQ (Frequently Asked Questions) of bowel preparation instructions would improve the quality     of the bowel preparation. The Wechat program has some advantages, 1. Wechat supports over 400     million users, nearly half of the mobile subscribers population in China; 2. Wechat provided     a real time communications including voice messages, pictures and text exchange timely;     3.Compare with telephone, Wechat is economical of both time and money; 4. Compare with bowel     preparation instructional software and litera or cartoon educational booklet, Wechat is more     interactive and responsive.   "
87506|NCT02140814|"     The goal of this pilot study is to evaluate the feasibility of administering niacinamide to     patients with autosomal dominant polycystic kidney disease, to develop methods to assess the     biological efficacy of niacinamide, and to perform a preliminary exploration of its clinical     effect on kidney cyst growth and kidney function.   "
87507|NCT02140801|"     A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with     a native coronary stenosis suitable for DES implantation and OCT imaging are openly     randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).   "
87508|NCT02140788|"     One purpose of this study is to test whether adding metformin will limit some of the unwanted     effects of clozapine, compared to not adding metformin. Metformin is a medication that is     approved by the United States Food and Drug Administration (FDA) for the treatment of type-2     diabetes. Studies have found that people with type-2 diabetes often lose some weight when     they take metformin, however the FDA has not approved metformin for weight loss, so for this     study the use of metformin is investigational. This study will test whether metformin can     help people with schizophrenia or schizoaffective disorders lose weight.      Another purpose of this study is to test whether adding fish oil will improve the benefit of     clozapine and/or limit some of the unwanted effects of clozapine, compared to not adding fish     oil. Fish oil is a medication used to reduce levels of some fats (triglycerides) in blood.     Some studies have found that adding fish oil reduces psychosis (voices, suspiciousness).     However the FDA has not approved fish oil for reducing psychosis, so for this study the use     of fish oil is investigational. This study will test whether fish oil can help people with     schizophrenia or schizoaffective disorders have less psychosis. Fish oil is not an     antipsychotic medication.   "
87509|NCT02140775|"     The current study is a randomized clinical trial comparing Behavioral Activation counseling     with supportive counseling for HIV+ participants presenting with clinically significant     fatigue whose energy has improved with armodafinil, who have the goal of returning to work or     vocational training but have not done so on their own. A second cohort of HIV+ participants     without significant fatigue at baseline, but who also have the goal of returning to work,     will also be randomized to either Behavioral Activation counseling or supportive counseling.     In both cohorts, the primary outcome is level of success regarding an employment related     goal.   "
87510|NCT02140762|"     Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single     dose of MenACWY vaccine.   "
87546|NCT02140138|"     The purpose of this study is to evaluate the induction of immune responses against CV9104     administered by conventional intradermal injection or with a needle-free intradermal     injection device and to assess the safety and tolerability of CV9104 administered by     conventional intradermal injection versus injection with a needle-free intradermal injection     device versus no injection.   "
87547|NCT02140125|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The     pharmacodynamics of ASP2408 is also being evaluated.   "
87511|NCT02140749|"     Rationale: The dietary short-chain fructooligosaccharides have been shown to increase fecal     bacterial mass and fermentation metabolites which might stimulate gut motility. Therefore,     these dietary non-digestible carbohydrates might relieve functional constipation.      Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.      Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with     intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4     weeks.      Study population: Human subjects with functional constipation according to ROMEIII criteria     (total n=120; male and female; 18-75 yr).      Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides,     (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral     chews.      Main study parameters: The primary parameter is the number of complete bowel movements per     day in subjects with functional constipation according to Rome III criteria. Secondary     outcomes are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms     (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation     Quality of Life; PAC-QoL).   "
87512|NCT02140736|"     The main aim of this study is to observe correction of the hemoglobin level in the patients     under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or     a lymphoma or a myeloma.   "
87523|NCT02140593|"     The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between     optimal surgical conditions and the risk of postoperative residual blockade.      The aim of the study is to investigate if intense NMB improves surgical conditions during     operation in patients scheduled for elective open upper abdominal surgery.   "
87869|NCT02135939|"     In this randomized study the investigators aim to determine the effects of a whole-food     plant-based vegan diet on markers of inflammation and glucometabolic profile in patients with     cardiovascular disease. The investigators hypothesize that a whole-food plant-based vegan     diet will reduce markers of inflammation and improve glucometabolic profile compared with the     American Heart Association (AHA)- recommended diet at 2 months follow-up in patients with     coronary artery disease (CAD). The investigators are also evaluating endothelial function     using the EndoPAT device and stool microbiome.   "
87513|NCT02140723|"     Background:      Meta-analyses of large randomized trials proved the superiority of preoperative short course     radiation and surgery, as compared with surgery alone. Short course radiation results in a     50% reduction in terms of local relapse in stage II and III rectal cancer patients. Patients     with complete pathological remission additionally show a significant survival benefit.     Complete pathological remission (pCR) occurs in 8% after preoperative radiation and in >16%     if the interval between radiation and surgery is at least 8 weeks.      It is generally accepted that mutations in the TP53 gene represent a crucial defect in the     apoptosis pathway. Radiation therapy is suggested to act via induction of apoptosis in     irradiated cells. Therefore, it is expected that a defect in the TP53 gene has an effect on     the success of radiation therapy.      Currently available imaging tools are hardly able to diagnose response to radiation therapy     correctly, as this does not essentially correlate with tumor size.      Method:      Aim of this prospective observation study is to strengthen the hypothesis that the TP53     genotype is a promising marker to predict response to radiation therapy in rectal cancer     patients. Consequently, the expected results will justify prospective, randomized     intervention trials to obtain level of evidence I for the p53 marker hypothesis. Trial     endpoint is downstaging and pCR rate. Tumor stage and pathological remission will be     evaluated by MRT and pathohistology and correlated to the TP53 genotype of the diagnostic     biopsy. Additionally, we will investigate the applicability of novel imaging modalities in     magnet resonance tomography to monitor response to radiotherapy.      The objective of this study is        -  to evaluate the effect of a genetic tumor marker (TP53 genotype) on the response to          preoperative short course radiation (in terms of downstaging and pCR rate)        -  to evaluate the applicability of novel magnet resonance tomography imaging modalities to          monitor response to preoperative short time radiation.      Conclusion:      The prospective evaluation of the potential predictive marker TP53 may bring us one-step     closer to an individualized therapy regimen, which allows the restriction of preoperative     radiation in rectal cancer to those patients who will benefit.   "
87514|NCT02140710|"     Timing of the first and last meconium stool is critical for oral feeding tolerance and proper     gastrointestinal function. The time until premature infants pass their first meconium ranges     from 1 hour to 27 days (median: 43 hours). Obstruction of the gastrointestinal tract by     tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and     delayed food passage Recent data support the concept that complete rapid evacuation of     meconium plays a key role in feeding tolerance . If duration to full enteral feedings is     extended, the probability to acquire infections due to intravenous access for parenteral     nutrition increases and hospital stay of the infant prolongates. Previously two prospective     trials focusing on the problem of delayed meconium evacuation in preterm with different     therapeutic pharmacological approaches were published by our group. None of the applied     therapies appeared to be effective or had a beneficial effect- quite the contrary one agent     (Gastrografin) was supposed to have severe negative side effects. Therefore we were looking     for an alternative, non-invasive, holistic solution for the problem of delayed meconium     excretion. Osteopathic treatment with the emphasis on the relationship of the structural and     functional integrity of the body and with its variety of therapeutic manual techniques seemed     to be remedy. Treating the abdomen of premature infants with visceral osteopathic techniques     might be more effective to mobilize meconium from small bowel and deep parts of the colon.     Therefore we hypothesized that repeated visceral osteopathic treatment accelerates meconium     evacuation in premature infants, and thereby enhances feeding tolerance in this population.   "
87515|NCT02140697|"     Obesity is a major health issue worldwide; there is a constant raise in obesity related death     each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract as a     novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L. Leaf     Extract supplementation on body weight regulation in humans are lacking.   "
87516|NCT02140684|"     This study will compare the absolute and relative effectiveness of managing real-life asthma     with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO)     as a marker of underlying airway inflammation to guide appropriate management. As exhaled     nitric oxide responds rapidly to environmental changes and can act as a marker of underlying     inflammation it is proposed that incorporating eNO monitoring into routine asthma management     treatment allows strategies to be more accurately tailored to the patients needs, increasing     the probability of good asthma control.   "
87517|NCT02140671|"     Following on from a 10 year study conducted in Finland this study is designed to test the     validity and sustainability of an enhanced asthma management model for the UK.   "
87518|NCT02140658|"     The purpose of this study is to assess the affect of multiple health education interventions     for statins medication compliance and clinical prognosis of ischemic stroke patients at 3, 6     and 12 months.   "
87519|NCT02140645|"     The objective of this study is to identify EMR-based clinical covariates and quantify their     association with the prescribing of each specific type 2 diabetes (T2DM) medication under     investigation. This will include an assessment of how well these covariates are captured     through claims data proxies, and their potential to confound comparative research of T2DM     medications.   "
87548|NCT02140112|"     This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric     patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment     and 16 weeks of placebo.   "
87562|NCT02139930|"     The main goal of this project is to compare two different approaches to reducing levels of     nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to     non-addictive levels or a gradual reduction in nicotine content in cigarettes to     non-addictive levels. These two approaches will then be contrasted to a group that continues     to smoke cigarettes with nicotine content similar to conventional cigarettes.   "
87520|NCT02140632|"     Carpal tunnel syndrome is caused by the compression of median nerve at the wrist where it     passes through a narrow space called carpal tunnel formed by the wrist bones, ligaments and     tendons. The common symptoms include numbness and pain over the areas supplied by the median     nerve namely the thumb, the index finger, the middle finger and the outer part of the ring     finger. There can be loss of sensation, weakness or muscle atrophy in severe cases. The     functions of the affected hands may be greatly impaired.      Carpal tunnel syndrome is very common. It can lead to significant economic impact both to the     affected individual and the society either by the direct treatment cost and indirectly from     the working ability loss. Despite the vast burden, there is no consensus regarding its     treatment so far. Surgery is generally effective and often reserved for severe cases. There     are many nonsurgical treatment options. Local steroid injection and wrist splinting are among     the commonest and with more evidence. Local steroid injection into the carpal tunnel can     reduce the inflammation and swelling. Wrist splinting can maintain the wrist at its neutral     position where the pressure at the carpal tunnel is the least. However, there are only very     few studies comparing these two treatments directly.      Patients complaining of finger numbness who have been confirmed to have carpal tunnel     syndrome by nerve conduction test are invited to participate in the study. The patients who     agreed to be recruited are asked about their basic informations and the details of the carpal     tunnel syndrome symptoms. Their hands will be examined. They are asked to fill in a     questionnaire specific for assessing the symptom severity and the functional status of     patients with carpal tunnel syndrome. They will then be assigned to one of the two treatment     groups randomly and receive the respective treatment. They need to come back for follow-up at     one month and to fill in the questionnaire again.      The study hypothesis is local steroid injection is more effective than wrist splinting in     treating carpal tunnel syndrome.   "
87521|NCT02140619|"     The study aimed to demonstrate the relationship between secondary prevention medication     compliance and clinical prognosis of ischemic stroke patients at 3,6,12 months   "
87524|NCT02140580|"     Trial question: Does administration of exogenous surfactant using a minimally-invasive     technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous     positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via a     minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of     mechanical respiratory support, and a higher incidence of survival without bronchopulmonary     dysplasia. Trial design: Multicentre, randomised, masked, controlled trial in inborn preterm     infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory     distress, with an FiO2 of >=0.3 and CPAP pressure 5-8. Infants randomised to surfactant     treatment receive 200 mg/kg of poractant alfa (Curosurf) administered under direct     laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP.     Controls continue on CPAP. The intervention is masked from the clinical team. Care thereafter     is as per usual in both groups, other than the requirement to adhere to intubation criteria.     The primary outcome is incidence of death or BPD. Secondary outcomes include incidence of     death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular     leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent     ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical     respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC),     oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability     and safety of the MIST procedure; and outcome at 2 years. The sample size is 303/group,     allowing detection of a 33% difference in the primary outcome with 90% power. The trial     commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and     will ultimately be conducted over 5 years in multiple centres internationally.   "
87525|NCT02140567|"     The purpose of this study is to perform a prospective evaluation of the vasovagal syncope     prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one     center in the United Kingdom.   "
87526|NCT02140554|"     This is a non-randomized, open label, multi-site, single-dose, Phase 1 study in up to 29     adults with severe sickle cell disease (SCD). The study will evaluate the safety and efficacy     of the LentiGlobin BB305 Drug Product [consisting of autologous CD34+ hematopoietic stem     cells (HSC) transduced with LentiGlobin BB305 lentiviral vector encoding the human beta     A-T87Q-globin gene].   "
87527|NCT02140541|"     To explore the relationship between blood eosinophil counts, asthma exacerbations and patient     asthma control using a large primary care based research database   "
87528|NCT02140528|"     This study is a case-control prospective, clinal trial to assess the safety and efficacy of     the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent     tibial fracture in 40 patients.   "
87529|NCT02140515|"     We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two     protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the     beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and     Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in     diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for     group B. Finally Assisted Reproductive Technology (ART) results are compared between the two     groups.   "
87530|NCT02140502|"     In this study, the investigators aim to establish the incidence of enteric fluoroquinolone     resistant bacteria in a contemporary clinical cohort. This incidence will be studied by     taking a rectal swab sample from all consenting patients coming in for prostate biopsies. The     information gained from this study will be used to determine whether antibiotic prophylactic     practices need to be updated in their clinic. The investigators aim to enroll 200 patients     and patient recruitment is estimated to take place between May 2014 and August 2014. The     study is estimated to end in May 2016.   "
87531|NCT02140489|"     The purpose of this study is to evaluate the drug-drug interaction between     amlodipine/losartan and rosuvastatin in healthy male volunteers.   "
87532|NCT02140476|"     Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical instruments     that use electrical powered diathermic energy to seal and transect tissue. These devices have     shown high efficiency in a wide variety of open and laparoscopic general and gynecological     surgical procedures.      The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic     cutting devices in several studies. However, the efficacy of this instrument and in     particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in     thyroid surgery.      Our primary aim is to verify whether the EnSeal® performance is superior to the standard     surgical technique for thyroidectomy in a randomized clinical trial on 2 different     institutions.   "
87533|NCT02140463|"     Analysis of cell free DNA(cfDNA), unlike tissue biopsy, presents a new tool for the     monitoring and treatment of cancer. The investigators have developed a differentiated     sequencing assay, Digital Sequencing Technology (DST) that enables detection of rare genomic     abnormalities with ultra high-specificity and sensitivity. The investigators assay is able to     eliminate the error and distortion created by sample-prep and sequencing processes in     standard NGS(next-generation sequencing ) workflows and produce near-perfect representations     of all rare variants.      The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 0.1%     cancer cell line titration samples, standard Illumina SBS(sequencing by synthesis ) generates     many high-quality false positive variant calls in the range of 0.05-5%, while the     investigators assay resulted in highly sensitive and completely error-free variant calls     across the entire panel.      This work indicates the remarkable potential of using the investigators assay in deep     analysis of cfDNA, thereby allowing researchers and clinicians to comprehensively and     non-invasively monitor the genetic dimension of cancer throughout the body.   "
87534|NCT02140450|"     To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular     pressure rise after intravitreal injection.   "
87535|NCT02140437|"     This research is designed to investigate whether the addition of fulvestrant 500mg to     anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced     breast cancer.   "
87536|NCT02140424|"     This is an observation study of girls ages 10-16 years with type 1 diabetes and age- and     race-matched controls. The investigators will be examining blood and urine hormone levels as     well as measures of bone density including DXA and high-resolution peripheral quantitiative     computed tomography. The investigators hypothesize that youth with type 1 diabetes will have     slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic     controls. The investigators hypothesize that poor bone accrual will be associated with     sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.   "
87870|NCT02135926|"     the purpose of this study is to to compare the safety and effectiveness of stent-retrievers     as a device class group with best medical care alone in the treatment of acute ischemic     stroke (AIS) in patients who are not eligible for IV-tPA up to 8 hours of symptom onset.   "
87537|NCT02140411|"     Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody     fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic     macular edema (DME), retinal vein occlusion and age-related macular degeneration.      Currently, there is limited epidemiologic information in Chile regarding the incidence of DME     and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy     of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and     functional improvement following this treatment and to increase the local experience     regarding the use of anti-VEGF in the treatment of diabetic macular edema.   "
87538|NCT02140398|"     Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with     polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction     medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that     endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these     women.   "
87539|NCT02140385|"     The purpose of this study is to determine whether leaving a thicker layer -which preserves     the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases the     damage to the lymphatic system.      In order to investigate the effect of leaving a thinner or slightly thicker layer intact     during a tummy tuck, patients who are already planning to undergo the surgery, and who agree     to participate, will be randomly assigned to two groups in a manner similar to flipping a     coin. The first group will have their abdominoplasty performed with a thinner layer of     abdominal wall left in place while the second group will have the surgery with a slightly     thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of     care, and the aesthetic outcomes will not be negatively impacted by either of the options.      Before and after the surgery, a procedure called lymphoscintigraphy will be performed.     Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is     injected and then detected by a special camera. The pictures provided by the     lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small     network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will     help investigators to know what method of performing the tummy tuck leaves the lymphatic     system most intact.      In addition, photographs of each patient's abdomen will be taken using a special camera that     allows investigators to put the photographs in the computer and compile a 3-dimensional     image. Investigators will be able to look at the volume changes from swelling after the     surgery using these pictures. Finally, an ultrasound will be used to help identify any     seromas, or fluid collections, that may form after the surgery.      The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether     or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid     draining lymphatic system and whether or not that effects recovery after the procedure.   "
87540|NCT02140372|"     This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour     later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug     administration, 2 hours after colchicine administration, and 24 hours after colchicine     administration via the antecubital vein and evaluated for markers of platelet activity and     inflammation.   "
87541|NCT02140359|"     Housing First programs are promising approaches to transitioning substance using chronically     homeless adults to affordable housing. However, Housing First programs need to provide     support to residents to adjust to their changing social environments. The proposed project     fulfills a critical gap by developing an electronic tool for a social network intervention     using motivational interviewing techniques as well as results of a pilot test of the tool.     The hypothesis to be tested is that Housing First residents who are given the intervention     will be significantly more motivated to change their drinking, drug use, sexual risk     behaviors, and social networks compared to controls receiving usual care.   "
87542|NCT02140346|"     RV1729 is a new medicine being developed for the potential treatment of asthma and smoking     related lung disease (also known as chronic obstructive pulmonary disease - COPD). The     objective of this study is to investigate the safety, tolerability, pharmacokinetics and     pharmacodynamics repeat doses of RV1729 in patients with COPD for 28 days.   "
87543|NCT02140333|"     The purpose of this study is to determine whether 100mg erlotinib had similar effect compared     with 150mg erlotinib in NSCLC patients with EGFR mutation in China.   "
87544|NCT02140320|"     RV1729 is a new medicine being developed for the potential treatment of asthma and smoking     related lung disease (also known as chronic obstructive pulmonary disease - COPD).      The objective of this study is to investigate the safety, tolerability and pharmacokinetics     of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.   "
87545|NCT02140307|"     The purpose of the study is to investigate health-promoting and stress-reducing     psychological, physiological and hormonal effects of a 9-week meditation-based course in     personal health and to examine potential baseline factors for any such effects. Thus, the     investigators will investigate the course format (individual course or group-based course) as     a potential factor the course outcome, and also individual background factors such as     demographics and genetic variations.   "
87549|NCT02140099|"     Adolescent risk behaviours, such as violence and substance use, are prevalent public health     concerns in Canada. Further, these behaviours often co-occur, and are associated with poor     mental health. However, the majority of prevention programs focus on preventing single issues     and do not consider mental health, and also neglect the importance of relationships when     promoting positive youth development. To address this gap, the Centre for Addiction and     Mental Health (CAMH) Centre for Prevention Science designed the Fourth R Healthy     Relationships Plus Program, a small group program focused on the promotion of positive mental     health and the reduction of violence and substance use, via the development of improved     communication, interpersonal and help-seeking skills. The purpose of this study is to     evaluate the Fourth R Healthy Relationships Plus program using both outcome (randomized     controlled trial design with follow-up at pre-test, post-test, and 4, 8 and 12 months) and     process evaluation tools.      The primary study hypothesis is that participation in the Fourth R Healthy Relationships Plus     program will be associated with positive growth in treatment participants' psychological     well-being from pre-test to 12-month follow-up, as compared to control participants. In     secondary analyses, the study will explore if treatment participants report less substance     use, peer violence, bullying and dating violence at 12-month follow-up than control     participants. Since certain person-level (e.g., sex, personality, executive functioning) and     program-level (e.g., implementation quality) variables may moderate treatment-outcome     relationships, these associations will also be explored. The final hypothesis is that     treatment participants will report better attitudes, knowledge and assertive communication at     post-test compared to control participants, and that these improvements will mediate the     association between program participation and 12-month outcomes.   "
87550|NCT02140086|"     A randomized, controlled trial to investigate the effects of a buteyko based remedial     breathing therapy on children with asthma regarding to their symptoms, use of medication and     lung function tests.   "
87594|NCT02139514|"     The purpose of this study is to predict and explain on the basis of brain function and     structure the behavioral and brain effects of an evidence-based intervention for adults with     high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012;     Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned     to receive either (a) two hours per week of intervention services for five weeks, or (b) a     treatment as usual control. The intervention will focus on enhancing social skills, social     cognition, and social functioning. Outcome measures will evaluate changes in these social     skills, cognition, and functioning using standardized assessments. We will perform structural     and functional magnetic resonance imaging (MRI) scans at three time points-before, during,     and after treatment (i.e., Time Point #1, 2, and 3).   "
87551|NCT02140073|"     The purpose of this study is to determine the efficacy, safety, and tolerability of     omeprazole in combination with domperidone in GERD treatment for subsequent efficient     pharmacotherapy of GERD.      Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone     regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of     treatment To compare the efficacy of omeprazole in combination with domperidone regarding     change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To     assess the efficacy of omeprazole in combination with domperidone regarding change of     incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare     the efficacy of omeprazole in combination with domperidone regarding change of incidence and     severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the     efficiency and advantages of one GERD therapy considering efficacy, safety, and individual     variance of patients' reactions   "
87552|NCT02140060|"     The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination     (Trav/Brinz) administered twice daily as compared to each of its marketed components     (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z®     plus AZOPT® in lowering intraocular pressure (IOP).   "
87553|NCT02140047|"     The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered     with DPT-IPV using ActHIB® as a control in healthy infants.   "
87554|NCT02140034|"     This study is carried out to determine the merit and reliability of extensive intraoperative     peritoneal lavage as a preventive strategy      Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk     of peritoneal recurrence   "
87555|NCT02140021|"     The goal of this clinical research study is to learn how often high-grade dysplasia or     invasive squamous cell carcinoma of the anus occurs in women with high-grade dysplasia     invasive squamous cell carcinoma, invasive adenocarcinoma, or AIS of the cervix, vagina, or     vulva.   "
87556|NCT02140008|"     Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The     pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices     for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The     air-Q is a new single-use device that may optimise the airway seal while reducing the     potential for postoperative complications such as sore throat. The overall structure of the     air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The     aim of this randomized trial was to compare the clinical performance of the i-gel and the     air-Q SP.   "
87557|NCT02139995|"     Guidelines for blood transfusion have been issued for years. According to these guidelines,     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the     guidelines, the determination of whether RBCs should be administered when the hemoglobin     level is in the range of 6~10g/dL is based on the judgment from doctors. Index of transfusion     trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and     important in clinical practice.      Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen     consumption, the investigators hypothesize that index of transfusion trigger for patients     with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including     infusion rate of inotropic drugs for maintaining normal cardiac output, fraction of inspired     oxygen, core temperature, and torlerance to anemia. To verify this hypothesis, the     investigators present West China Transfusion Score for Critically-ill Patients(WCTS-CP) for     the trigger of transfusion according to the patient's history and monitoring parameters, and     the investigators design a randomized controlled clinical trial to test this score.   "
87558|NCT02139982|"     Phase 1 Sympathetic block leads to vasodilatation and increases in blood flow. However,     regional hemodynamic changes of radial and ulnar artery after specific nerve block of     brachial plexus remains unclear. The aim of the study is to assess the effect of specific     nerve block of brachial plexus on hemodynamics of upper extremity, and provides evidence for     further research in patient undergoing microvascular surgery.      Phase 2 There is no literature about dose-finding studies of sympathetic block after brachial     plexus block. Little is known regarding the relationship between concentration of local     anaesthetic and vasodilation of upper extremity. The aim of this randomized, double-blind,     prospective dose-response study is to determine the ED50 and ED95 of ropivacaine in     sympathetic block of upper extremity after supraclavicular block   "
87559|NCT02139969|"     The purpose of this study is to gain information on the safety, efficacy, and quality of life     in subjects who have had the GreenLight XPS procedure.   "
87560|NCT02139956|"     Continent women have an intact internal urethral sphincter that extends from the bladder neck     down to the perineal membrane. The internal urethral sphincter is a strong collagen muscle     tissue cylinder lined by urothelium. On ultrasound scanning tissue echo will be detected torn     internal urethral sphincter will not stand sudden rise of abdominal pressure. Three     dimensional ultrasound assessment of the internal urethral sphincter is very sensitive and     specific for the diagnosis of stress urinary incontinence.   "
87563|NCT02139917|"     Primary aim:        1. To compare the effects of customary care and an interventional Home-based Palliative          Renal Program (HBPRP) for ESRF patients        2. To compare the effects of customary care and Home-based Palliative Program (HBPP) for          ESRF patients           Secondary aim:        3. To explore the lived experiences of patients with ESRF. Hypothesis The transitional          renal palliative care model is associated with decreased in unscheduled hospital          readmission, reduce length of stay as well as improved quality of life for patients with          end-stage renal failure.   "
87595|NCT02139501|"     The project was undertaking by Qilu Hospital of Shandong University and other well-known     hospitals in China. In order to study the efficacy and safety of different dose and frequency     Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)   "
87596|NCT02139488|"     To quantify motion based variation of the target volume of the primary tumor over the course     of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate     appropriate PTV (planning target volume) margins according to the margins recipe for patients     receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation     in order to personalize radiation treatment, resulting in either better target coverage or a     reduction in normal tissue radiation exposure.   "
87564|NCT02139904|"     This study is for patients with malignant mesothelioma of the lung lining (called pleura) who     have had previous chemotherapy with a platinum-based regimen whose disease has progressed.     Malignant pleural mesothelioma (MPM) is an aggressive, frequently drug resistant, and     incurable disease that is increasing in incidence in the UK and worldwide. All patients with     MPM will relapse following first line chemotherapy and at present, there is no standard     treatment available for patients in the second line setting. The vinca alkaloid chemotherapy     drug vinorelbine has shown promising activity in a single arm UK trial. However to date,     there has been no randomised evaluation of vinorelbine in mesothelioma in the second line     setting. In addition, there have been no trials which have looked at underlying molecular     changes in mesothelioma which may predict vinorelbine efficacy; This might allow vinorelbine     to be used in patients only where there is a chance of benefit. Studies suggest that     vinorelbine requires a gene called BRCA1 (shown to be absent in 38% of mesothelioma cases) in     order to induce cell death in mesothelioma. The VIM trial aims to establish whether     vinorelbine in patients with MPM helps them live longer and whether the BRCA1 gene is helpful     in selecting patients most likely to benefit from treatment.      Patients will be randomised (1:2) to receive either active symptom control (ASC) (which is     all supportive care deemed necessary for pain management excluding disease modifying     treatment) or ASC with vinorelbine. Patients will continue vinorelbine treatment until     evidence of disease progression (or unacceptable toxicity to the drug or patient withdrawal).     If vinorelbine activity is demonstrated, we will use the results from this trial to inform     the design of a future phase III trial.   "
87565|NCT02139891|"     This study will examine the additional clinical benefit conferred by multipoint pacing (MPP)     compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs.     OFF and followed for a total of 6 months. This includes two crossover periods for each pacing     modality (MPP on vs. off).   "
87566|NCT02139878|"     Researchers at the University of Prince Edward Island want to learn about the health effects     of wild blueberry juice.   "
87567|NCT02139865|"     When practicing weightlifting regularly the body makes new proteins within the muscle.      These new proteins can increase the size of the cells within the muscle to make them larger,     a process called hypertrophy. The common convention surrounding gains in skeletal muscle size     and strength is that heavy weights are needed. In contrast, lifting lighter weights are     thought to be required to induce muscular endurance and not to promote growth. However, it     has previously been shown in untrained men that lifting lighter weights results in similar     gains in muscle mass and strength as lifting heavier weights. The purpose of this study is to     examine how performing resistance training of different intensities (light or heavy weights)     affects the degree of muscle growth and strength gain in individuals who are already     resistance training.      This information will be valuable when designing exercise protocols for increasing muscle     size and strength at all ages, or in individuals returning from injury, as a way to stimulate     muscle growth and promote strength gains without the need to lift heavy weights.   "
87568|NCT02139852|"     Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate     increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy     intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for     weight loss supplements. Of particular interest are the recent findings that free-fatty acids     in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or     sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting     some of the negative consequences of other stimulants may be avoided. At present, however,     more in depth investigations of the effects on endothelial function, vascular autonomic tone     and inflammation are lacking.      The investigators seek to understand the effect of 3 months capsaicinoid ingestion on     alterations in body composition, traditional cardiovascular risk factors and cardiovascular     function      Hypotheses:      1) Continued use of capsaicinoids will alter resting metabolism substrate use, which will     result in moderate (but clinically meaningful) alterations in body composition manifested as     a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will     brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this     could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone.     However, previous research suggests that these alterations will not be manifested in     autonomic nervous tone assessed by changes in heart rate variability.   "
87569|NCT02139839|"     The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14     delivered via capsules to the vagina of post-menopausal women over a three day course of     treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis     of microbial ecology, human microarrays and multiplex immunological assessments are included     to characterize potential effects.   "
87570|NCT02139826|"     The purpose of this study is to compare the absorption and blood levels of IX-01 when given     as a capsule compared to liquid form, and how food affects the absorption in healthy men.   "
87592|NCT02139540|"     Major depressive disorder (MDD) is a global medical problem with significant shortcomings in     current therapy. Chief among these is the delay between initiation of pharmacologic therapy     and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has been     shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another     NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and     perhaps without the need for intravenous access and anesthesia personnel. Therefore, we     propose conducting a pilot randomized placebo controlled double-blind crossover study in     which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for     a period of one hour in addition to standard medical therapy. Depression severity will be     assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using the     Hamilton depression rating scale.   "
87709|NCT02138019|"     The fibrin sealants are prepared from fibrinogen, thrombin, and sometimes factor XIII that     have been purified from human plasma. Tissucol Duo Quick (Baxter, Vienna, Austria) is a kind     of fibrin sealants with popular use. It is a 2-component tissue adhesive that resembles     natural fibrin formation. This glue has 2 components: fibrinogen (mixed with factor XIII and     aprotinin) and thrombin-CaCl2 solution. When equal amounts of the 2 components are mixed, the     monomers aggregate by cross-linking, resulting in a fibrin clot. It forms a elastic, whitish     substance and provides strong adhesion to the tissue. Therefore, it is a good agent to seal     small wounds or to replace the use of suture.   "
87571|NCT02139813|"     Several prospective trials and metaanalysis have demonstrated the superiority of bariatric     surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure     has been practiced for more than 30 years, and is the procedure of choice for morbidly obese     with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a     technically demanding procedure with a learning curve of more than 75 cases. The complication     rate is around 10% in expert centers.      More recently another procedure has been described which seems as efficient on weight loss     and co-morbidities as the RYGBP, with the advantage of being less technically difficult and     less morbid, especially for multi-complicated obese and/or the super obese. It consists of a     unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop.     However, this procedure could be at risk of biliary reflux and anastomotic ulcers with     dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass     (OLB) has only been developed by a few teams and remains a controversial subject,     particularly as only one monocentric randomized trial has compared it to the RYGBP, which is     remains the gold standard. The first litterature results show similar or even better weight     loss efficiency than RYGBP with a better feasibility. The early complication rate seems     lower, but there are still insufficient data on long term morbidity and biliary reflux     consequences.      By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the     investigators study is to analyze the weight loss efficiency, the morbidity and mortality,     the feasibility, and the quality of life of both techniques, in order to validate the Omega     loop bypass as a procedure of choice in bariatric surgery      Hypothesis :      The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could     be less morbid.   "
87572|NCT02139800|"     This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which     of two strategies at birth are best to optimally aerate the lung of preterm infants.     Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring     respiratory support at birth which of two lung opening strategies - either a standard     PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment     using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined     endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.      Hypotheses:        1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will          reduce the need for mechanical ventilation in the first seven days of life, and reduce          need for surfactant use; and        2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36          weeks post-menstrual age (PMA) than standard PEEP/CPAP   "
87573|NCT02139787|"     The purpose of this study is to use a community based participatory action research (CBPAR)     approach to 1) create radio stories about Somali, Latino and Hmong families' real success     stories with hypertension and obesity in managing their disease through implementation of     healthful lifestyle behaviors (nutrition and physical activity), and 2) test the     effectiveness and acceptability of radio stories on participant intentions to engage in or     improve healthful lifestyle behaviors to prevent these disease. Participants in the     Intervention condition listened to the radio stories and the participants in the control     condition listened to an audio brochure with relevant health information. We hypothesized     that the intervention participants would report higher intentions to engage in various     healthful lifestyle behaviors than the control participants after both participants listened     to their respective health information.   "
87574|NCT02139774|"     This study is testing a walking program called Walk with Ease by the Arthritis Foundation     with men undergoing treatment for prostate cancer. The researchers are interested in how easy     or difficult it is for these men to participate in this program and whether or not is is     helpful to them during their care.   "
87575|NCT02139761|"     Cocaine continues to be one of the most widely used substances of abuse around the world. In     the US, an estimated 1.4 million individuals (0.5%) > 12 years were current (past month)     cocaine users in 2011. Currently, no FDA-approved pharmacologic treatments are available for     cocaine addiction; thus, this remains a serious public health problem without an effective     pharmacological treatment. A promising lead towards an effective treatment comes from a     recent finding that pretreatment with oral l-tetrahydropalmitine (l-THP) in rats attenuated     the cocaine seeking associated with a cocaine challenge, while having no motor effects. This     finding stimulated our group to test the pharmacokinetics and safety of l-THP in a phase I     study of people with cocaine use. Preliminary findings show l-THP is safe and well tolerated     in cocaine users, with no adverse interactions with cocaine.      This study will test the efficacy and safety of l-THP for abstinence in those with cocaine     addiction in a phase II pilot study (N=24). Secondarily, we will examine the effects of these     medications on craving.   "
87576|NCT02139748|"     Dental implant placement and simultaneous grafting using one layer gum graft will result in     the same facial ridge contour and soft tissue thickness as one layer of gum graft plus bone     graft.   "
87577|NCT02139735|"     The combination of ultrasound and muscular stretching may have positive effects on pain     relief and on the balance of the masticatory muscles activity.   "
87578|NCT02139722|"     Liver cancer and hepatitis B are major health disparities for Asian Americans, while     hepatitis C is a rising problem. Little is known about how to improve the quality of health     care Asian Americans receive in general and for viral hepatitis in particular. Technology,     specifically mobile applications, potentially can provide a flexible and efficient way to     address these challenges. This proposed project seeks to develop, implement, and test an     intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare     systems in the San Francisco Bay Area.      The research team will develop, implement, and evaluate the efficacy of an interactive,     patient- centered mobile application for use on a tablet computer to increase the rate of     hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will     use their experience from a successful track record in health promotion to develop the     intervention by working with patients, community leaders and advocates, clinical staff,     healthcare providers, and healthcare system administrators from a county safety net system     and an academic primary care practice in the San Francisco Bay Area. The mobile application     will include video clips with a physician (Video Doctor) addressing patient concerns     regarding hepatitis B and C screening in the patient's preferred language, English, Chinese,     or Vietnamese. A patient who has not been screened for hepatitis B will answer questions     about his or her characteristics and preferences using the mobile application. The mobile     application will then show 30-60 seconds video clips with messages that address the patient's     responses related to hepatitis B screening and that are delivered by an actor playing a     physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C     screening. At the end, the tablet computer will generate a provider alert to let the treating     provider know what the patient's preferences are regarding testing for viral hepatitis.      Once developed, the intervention will then be used in combination with a physician panel     notification and tested against physician panel notification only in a randomized controlled     trial to see which approach is better in increasing the rate of hepatitis B and C screening.     The team will also work with the 2 healthcare system to ensure that the interventions will be     practical and easily adopted once the study is over. The findings of this project will     greatly expand understanding about how to use technology- based interventions to improve     quality of healthcare in diverse patient populations.   "
87593|NCT02139527|"     The purpose of the registry is to assess outcomes following treatment with lumbar total disc     replacement (TDR) in patients outside the clinical trial setting.   "
88685|NCT02125266|"     This study is intended to evaluate the safety of V404 PDS in patients with chronic     non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide     clinically measurable benefit over an extended period of time in patients with chronic     non-infectious uveitis.   "
87579|NCT02139709|"     The overall objective of this study is to demonstrate how dietary ganglioside may protect the     gut attenuate inflammatory signals in the intestinal mucosa.      Gangliosides are dietary fats found in milk and are important constituents of intestinal     cells. Our previous studies have shown that inflamed intestinal mucosal cells have reduced     ganglioside content compared to normal mucosal cells. Gangliosides are glycolipids found on     the surface of the intestinal mucosa and in lipid rafts in enterocytes and lymphocytes.     Gangliosides influence microbial attachment, cell division, differentiation, signaling and     mucosal integrity. Preclinical studies show that provision of ganglioside in cell culture and     in animal diets increase ganglioside content in mucosal cells and down regulates signals     caused by pro-inflammatory stimuli. In subjects with active Crohn's disease, consumption of     ganglioside remarkably improved the Crohn's Disease Activity Index. In healthy control     subjects, dietary ganglioside improved intestinal permeability and decreased production of     pro-inflammatory prostaglandin E2.      It is proposed that ganglioside degradation is elevated in the inflamed gut of IBD patients.     Provision of ganglioside in the diet replaces ganglioside in the gut, consequently restoring     proper structure and function to the diseased intestine and inducing disease remission.     Insight into diet-based treatment would allow IBD patients to live healthy and happy lives.     The main research objective is to characterize how ganglioside catabolism is associated with     increased signaling from pro-inflammatory mediators and how reduction in ganglioside levels     can be ameliorated by ganglioside supplementation during active inflammatory disease. This     study will assess molecular mechanisms by which ganglioside alters gut permeability,     inflammatory mediators and cell signaling.   "
87580|NCT02139696|"     To evaluate the usability of positron emission tomography imaging as a novel outcome measure     in multiple sclerosis studies   "
87581|NCT02139683|"     The purpose of this study is to assess the treatment of fibroadenomata with a circumferential     sonification treatment with HIFU..   "
87582|NCT02139670|"     In total 120 pregnant women's with history of recurrent miscarriages, are planned for     inclusion in this trial. After signing an informed consent a blood sample will be obtained     from each participant. The investigators will measure the thrombin generation in plasma     assessed by the calibrated automated thrombogram (CAT). The relation between pregnancy     outcome and thrombin measurements will be determined   "
87583|NCT02139657|"     This is a single-arm, open-label study of Rabies Immune Globulin (Human),     Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose     of this study is to characterize the rabies virus-specific antibody titer after a single     intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of     RIG-C.   "
87584|NCT02139644|"     The primary objective of this study was to evaluate the efficacy of fluticasone propionate     multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate     multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years     of age and older with persistent asthma.      Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and     provided for participants to use at home. Participants performed spirometry at every visit.     Each participant was given a diary at each visit for use until the next visit. Rescue     medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by     the investigational center personnel.   "
87585|NCT02139631|"     The noninvasive ventilation (NIV) is a method of ventilatory support that does not require     artificial airway. Its application is associated with complex hemodynamic repercussions,     therefore is important to identify them for safety and effectiveness of the technique     application.      The main objective of this research is to evaluate the hemodynamic repercussions using     doppler echocardiography in healthy volunteers submitted a different values of positive end     expiratory pressure (PEEP) by the following ventilatory modes: Continuous positive airway     pressure (CPAP) and Bilevel.      The study hypothesis is that the positive end expiratory pressure (PEEP) may cause     hemodynamic repercussions as: reduction of the ventricles pre-load, left ventricle after     load, cardiac output and reduction in the diameter of the superior vena cava, due to the     increase in the intrathoracic pressure and pulmonary volumes.   "
87586|NCT02139618|"     Treatment of actinic damage has included multiple procedures but to date there is limited     scientific evidence to support the preferential use of one of these therapies according to     their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy     of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage   "
87587|NCT02139605|"     Stomach cancer is the second most common cause of cancer-related deaths in India. Curative     surgery offers the only chance of improving survival in this cancer. In patients whose cancer     has not spread to other parts of the body (beyond the stomach and lymph nodes around it),     removal of stomach (gastrectomy) with lymph nodes around the stomach and along the major     vessels supplying blood to the stomach (D2 lymphadenectomy) is regarded as current standard     of care at Tata Memorial Centre. However, the extent of lymphadenectomy is controversial.     Some studies have suggested that removing more lymph nodes, even around the major vessels of     the abdomen (aorta and inferior vena cava) may not only help to accurately determine the     disease spread, but may also confer an additional survival benefit. Removing more lymph nodes     around the major vessels may increase the risk of morbidity to the patient.      In the last 5-6 years, stomach cancer specialists around the world have resorted to giving     half the cycles of chemotherapy to the patient before the surgery (neoadjuvant chemotherapy),     and the other half after the surgery in what is called 'perioperative chemotherapy'. This has     been shown to lead to more patients surviving to 5 years, than before.      The investigators feel that perioperative chemotherapy with D2 lymphadenectomy may constitute     the best care for our patients with stomach cancer such that no further removal of lymph     nodes beyond is required. However, the investigators have no evidence in literature to     support this hypothesis. The investigators have thus designed this trial based on which we     propose that there exists no difference between a D2 lymphadenectomy and a D3 lymphadenectomy     following neoadjuvant chemotherapy for non-metastatic, locally advanced but resectable     gastric cancer. The data will enable the development of clear management guidelines for lymph     node dissection in stomach cancer.   "
87588|NCT02139592|"     The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for     IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's     lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to     collect efficacy information for reference.   "
87589|NCT02139579|"     Epidermal growth factor receptor (EGFR) tyrosine kinase is one of most popular target     molecules in the field of anticancer drug research. EGFR is highly expressed in many types of     tumor cells, which could activate EGFR cytosolic kinase activity by binding to its ligand     EGF, and regulates gene expression, cell proliferation, differentiation, apoptosis through     different signal transduction pathways. Epidermal growth factor receptor tyrosine kinase     inhibitor (EGFR-TKI), competitive to specifically combined with the EGFR kinase domain, thus     inhibits its kinase activity, thereby blocking cancer cell proliferation or metastasis. At     present, EGFR-TKI has been widely used in clinical activity, especially in patients with EGFR     mutations, which had been proved to achieved a certain effect. But with the passage of time,     a drug resistance is inevitable.      At present, studies have found that the cessation of treatment immediately after EGFR-TKI     resistance may lead to rapid progress of cancer. Chemotherapy, as one of the most widely     accepted modality in cancer treatment, might also be one of the salvage therapies of target     treatment. Therefore, in patients with better physical status (PS) scores, chemotherapy is     commonly applicable.      In January 2010, a study published in the journal of Clinical Lung Cancer reported the     application of chemotherapy as salvage treatment for advanced non-small cell lung cancer     (NSCLC) patients with resistant to first-line EGFR-TKI treatment. Of the 114 patients     enrolled, 67 received sequential chemotherapy, the other 47 patients received best supportive     care. The results showed that, sequential chemotherapy can improve the survival time of the     patients, compared with chemotherapy and supportive care groups (11.2 months vs. 3.8 months,     P< 0.01). Furthermore, in those who received sequential chemotherapy, a regimen containing     paclitaxel got higher efficiency and disease control rate than those without (48.7% vs.     21.4%, 79.5% vs. 53.5% , P< 0.05), as well as longer progression-free survival (PFS, 5.1     months vs. 1.8 months, P< 0.01) and overall survival (OS, 12.7 months vs. 7 months, P< 0.01).      Another study in Taiwan which enrolled 195 patients treated with at least 1 cycles sequential     chemotherapy after first-line gefitinib shown similar results. Generally, gefitinib as a     first-line treatment had PFS for 5 months, and the second-line treatment efficiency was     14.4%. Regimens of platinum or paclitaxel had a better treatment efficiency (50.6%). A poor     therapeutic effect was reported for gefitinib as second-line therapy (5.6%). In total, the     median OS of second-line treatment was 12.2 months. In addition, platinum containing regimens     survival better (21.7 months vs. 8.9 months, P< 0.01); patients with mutant EGFR benefit more     in a platinum-based chemotherapy (24.5 months vs. 8.5 months, P< 0.05).      Bevacizumab (trade name Avastin ®) is a kind of recombinant humanized monoclonal     immunoglobulin gamma-1 (IgG1) antibody, which can selectively inhibit the combination process     of vascular endothelial growth factor (VEGF) and its receptor, Flt-1 and kinase domain     receptor (KDR) in endothelial cells. A reduction of tumor angiogenesis, blood supply, oxygen     and other nutrients supply could be obtained after the VEGF loss of its biological activity,     thus inhibit tumor growth. The drug was approved for the first-line treatment of advanced     colorectal cancer in 2004 by America food and Drug Administration (FDA),thus became the first     for clinical use of drugs that targeting VEGF. As the first globally approved anti-angiogenic     monoclonal antibody drugs, bevacizumab has approved for advanced colorectal cancer, lung     cancer, breast cancer, renal cell carcinoma and malignant glioma patients, which was used in     more than 500000 cases. In the field of advanced NSCLC treatment, clinical results confirm     bevacizumab combined with chemotherapy can prolong OS and PFS of patients with NSCLC, and     well tolerated.      The thirty-fifth annual meeting of the European Society of Medical Oncology (ESMO) conference     released a meta analysis results of bevacizumab combined with platinum chemotherapy for     first-line treatment of advanced non squamous NSCLC. It is confirmed that, treatment with     bevacizumab based chemotherapy for advanced non squamous NSCLC patients could achieve     significant survival benefit, prolong remission time, and expected safety.      Therefore, the investigators design this phase II to testify the efficacy and safety of     bevacizumab + chemotherapy for EGFR-TKI resistant non squamous NSCLC.   "
87590|NCT02139566|"     A two-part study to test the efficacy of alternative consent procedures and the efficacy of     alternative methods to improve survey completion.   "
87591|NCT02139553|"     The purpose of this study is to determine whether rhythmic upper-limb movement training in     post-stroke patients allows to improve only this particular type of movements or if it also     improves some parameters of discrete movements. Based on our results we hope to be able to     answer a fundamental question: are rhythmic and discrete movements two independent     primitives?   "
87605|NCT02139371|"     The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for     PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential     of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and     less aggressive tumors. This is a first in human study to test the radiotracer in cancer     patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (1,3     and 24 hours post injection).   "
87871|NCT02135913|"     This is a pilot study to determine the association between Vitamin D deficiency in obese     children and low high density lipoprotein (HDL) and dysfunctional HDL.   "
87597|NCT02139475|"     The aim of this study is to clarify the factors influencing quality of bowel cleansing for     colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel     cleaning method for patients with colorectal cancer surgery. Through this, ultimately in     patients with a history of colorectal cancer who have high risk of colorectal cancer, it     could be possible to detect cancerous lesions early and increase the survival rate.      This study is based on observational study Subjects are the patients with colorectal cancer     surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical     records on the basis of information collected at the point of the colonoscopy performed     Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient     compliance and satisfaction are measured.   "
87598|NCT02139462|"     This study will use a data base of archived therapy sessions of family therapy for adolescent     anorexia nervosa to determine the role of fidelity to treatment and outcome. In addition, it     will develop a novel, more efficient way to train therapists in family therapy for adolescent     anorexia nervosa and examine if it is feasible to conduct a trial comparing this novel     training to standard, more intensive training.   "
87599|NCT02139449|"     CRT and ICD has known as decreasing cardiac mortality in patient with heart failure.     Especially, it has reported that CRT improved cardiac systolic function, quality of life of     patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So we     will register patients who implant CRT or ICD (primary), and follow them up. During scheduled     follow up, all patients will perform echocardiography, 6 minute walking test, EKG, Holter     monitoring and questionnaire on QOL.   "
87600|NCT02139436|"     Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year,     there are profound declines in physiologic function, forming the underlying substrate for     future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly     recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely     understood, the almost 10-fold prevalence of cardiovascular disease results in part from     profound physiologic 'detraining' resulting from motor impairment and immobility. Currently,     effective interventions preventing acute declines that lead to cardiovascular compromise and     increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and     when employed, is typically limited to the upper body. Recently, the investigators refined a     unique form of exercise for those with SCI that specifically mirrors exercise performed by     those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples     volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile     that produces the beneficial cardiac loading conditions of large muscle mass exercise. As     such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following     SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate     against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening     lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening     and declining ventricular function occurring with acute SCI, and that these effects will be     greater than that observed with an arms-only exercise group. Changes with FES-RT will be     compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within     the last 3-6 months will be randomized to immediate FES-RT, to a time control beginning     FES-RT after a 6 month wait, or 6 months of arms-only-RT followed by FES-RT. Measures will be     made at baseline and every 3 months. The investigators work will provide results that clearly     delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of     those with SCI, its application, implementation, and integration could be easily replicated.   "
87601|NCT02139423|"     Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in     most maternities in France to detect symptomatic hearing impairment at birth but screening of     cCMV infection is not coupled with this screening. In this study, the feasibility of     achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as     the confirmation of hearing loss in newborns who failed newborn hearing screening will be     tested.   "
87602|NCT02139410|"     Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation     of this hormone has been reported to influence the genesis of cognitive impairment and     dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of     Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.   "
87603|NCT02139397|"     The purpose of this research study is to evaluate an investigational drug (DFMO) in     combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an     investigational drug because it has not been approved by the U.S. Food and Drug     Administration (FDA). This study will look at the safety and tolerability of DFMO in     combination with bortezomib as well as the tumors response to this study drug.   "
87604|NCT02139384|"     The purpose of the study is to create a clinical pneumonia tool that can be used to predict     the cause of community-acquired pneumonia, which is a lung infection that began outside of     the hospital in critically ill children therefore limiting unnecessary antibiotic use. The     investigators will enroll critically ill children admitted with acute respiratory failure and     suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from     culture and respiratory viral panel results. All care after samples obtained will be at the     discretion of the PICU team. The investigators believe that our clinical pneumonia scale with     procalcitonin will accurately designate viral from bacterial etiologies.   "
87611|NCT02139293|"     The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous     system stimulation on cardiovascular parameters and sympathovagal balance in healthy     subjects. It is investigated if auricular vagal nerve stimulation affects heart rate     variability as well as peripheral local blood perfusion, and if this effect depends on the     site of stimulation in the auricle, whereas four distinct stimulation points are tested.   "
87612|NCT02139280|"     No prospective randomized trials have evaluated the most efficacious dose of cyclophosphamide     to mobilize autologous stem cells. We previously demonstrated that the time to collection of     autologous hematopoietic stem cells is 10-12 days following the one dose of cyclophosphamide     and daily G-CSF (granulocyte-colony stimulating factor).9 This prospective randomized trial     is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2) will be as     efficacious as the intermediate dose (3 gm/m2), based on cell number collected, number of     apheresis required and resource utilization.   "
87613|NCT02139267|"     The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and     access the efficacy and safety of GX-188E according the protocol in patients with Cervical     Intraepithelial Neoplasia 3 (CIN3).   "
87710|NCT02138006|"     To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in     type 1 diabetes patients former randomized to intensive insulin treatment   "
87711|NCT02137993|"     The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to     Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective     disorder.   "
87614|NCT02139254|"     Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or     first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized     before pregnancy, the term pregestational diabetes (PGD) is used. In the last years, much has     been invested to uniformly define worldwide the diagnostic criteria and the management of     gestational diabetes. A general screening in a low risk population should be implemented into     routine prenatal care. Similarly, pregnant women at high risk for metabolic disorders should     be screened in the early pregnancy.      The aim of the following study ist to investigate the role of first trimester glycosylated     haemoglobin (HbA1c) of pregnant women with risk factors in developing gestational diabetes     mellitus (GDM).   "
87615|NCT02139241|"     The purpose of this study is to assess the effects of ramosetron on corrected QT interval in     patients undergoing off pump coronary artery bypass surgery.   "
87616|NCT02139228|"     Evaluate the persistency of immune response against Haemophilus influenzae type b by     assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT     booster vaccine approximately 4 years before.   "
87617|NCT02139215|"     This is a phase IV multicenter trial to evaluate real-world health outcomes and economic     impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with     chemotherapy-refractory metastatic colorectal cancer (mCRC).      The study will enable real-life health economics and outcome research (HEOR) to assess the     impact of panitumumab in the Quebec population.      The primary objective is to evaluate real-world health outcomes and economic impact of     panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with     SOC. The secondary objectives are to confirm survival data, to assess the quality of life of     patients and to assess the health care resource utilization of patients.      Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients     with a non-mutated (wild type) KRAS gene will be treated with panitumumab.      During the course of the study, data will be collected on quality of life and work     productivity. Patients will be asked to fill a set of questionnaires at their recruitment in     the study and at every 3 months after treatment initiation.   "
87618|NCT02139202|"     This is a 6-month pilot study intended to test the effect of financial incentives on     improving medication adherence in AMI patients; to test the effect on adherence of removing     financial incentives; and to test the effect on the enrollment rate of modifying recruitment     procedures.   "
87619|NCT02139189|"     The purpose of this CorMatrix P-ECM safety and feasibility study is to evaluate the safety     and functional effect of the CorMatrix P-ECM.   "
87620|NCT02139176|"     In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven     challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking     behaviors than women. They are less likely to be tested for HIV, initiate combination     antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage     in the care of their female sex partners, even though couple care-seeking is associated with     marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program     for providing immediate, lifelong combination antiretroviral therapy (cART) to all     HIV-infected pregnant women at the time of diagnosis, is an important entry-point for     involving male partners in care.      This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male     partner involvement within the Option B+ program. In both arms (patient referral and contract     referral) women will be encouraged to invite their male partners to accompany them to the     clinic for couple HIV counseling and testing. In the contract referral arm, if the couple     does not present within one week, the male partner will receive a home visit encouraging them     to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling     and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men.     Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's     HIV program.      Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+     context. We will assess acceptability of eligible females to participate in this pilot RCT     and reasons for non-participation.      Objective 2: Assess whether study arm (patient referral versus contract referral) is     associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of     male partner recruitment. This study will contain two arms: patient referral and contract     referral for uptake of cHTC (primary outcome).   "
87621|NCT02139163|"     Long-term objectives of the basic research part are improvement of CAP-management with     respect to therapy, diagnosis and prevention to contribute to a better care of patients with     pneumonia.   "
87622|NCT02139150|"     The purpose of this study is to see if PET/CT scans that use a radioactive substance called     [18F] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive     substances are used with PET/CT scans to see cancer cells, and are also called     radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT     PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard     clinical scan and is commonly used. The investigators would like to know if there is any     evidence of early treatment response by obtaining FLTPET/ CT scans before and after     treatment.   "
87623|NCT02139137|"     The study is designed to evaluate the effect of a novel computer training program on PTSD.   "
87624|NCT02139124|"     The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to     evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD   "
87625|NCT02139111|"     The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to     evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.   "
87626|NCT02139098|"     The purpose of this study is to evaluate whether drug efficiency of zolpidem and     amitriptyline can be conditioned according to learning theory in patients with primary     insomnia.   "
87652|NCT02138760|"     Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy have     a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance imaging     (mpMRI) is an imaging test that may improve prostate cancer detection rates in this     population of men. In this prospective randomized trial multicenter trial the investigators     will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared     with the addition of either a computer targeted system (UroNav - InVivo corp) to sample     suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy     (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided     biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of these     areas and systematic biopsy alone.   "
87653|NCT02138747|"     The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER     in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the     impact of treatment on micturition frequency and incontinence episodes.   "
87654|NCT02138734|"     This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus     ALT-803 in Non-muscle invasive bladder cancer.   "
87627|NCT02139085|"     Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that     adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency     treatment have a lower risk of iatrogenic injuries and offer faster return to work     activities, when compared with open surgical techniques. Endovenous electrocoagulation can     selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical     results has never been studied before.      Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation     and radio frequency (RF) endovascular varicose vein treatment clinical results and quality of     life improvement in a prospective double blind randomized controlled clinical trial.      Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized     to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure     will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning     (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising,     neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and     Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical Severity     Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained preoperatively, at 3     and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the     Mann-Whitney test and Pearson's correlation, considering positive statistical significance     when level of p <0.05.   "
87628|NCT02139072|"     The purpose of this study is to see if the CoaguChek XS is accurate in measuring     International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome     (APL) receiving warfarin therapy.   "
87629|NCT02139059|"     To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy     without initial urinary drainage in the treatment of obstructive calcular anuria with acute     renal failure in children.   "
87630|NCT02139046|"     The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended     release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80     mg IR, respectively, in participants with gout.   "
87631|NCT02139033|"     This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs     and symptoms of dry eye syndrome.   "
87632|NCT02139020|"     The investigators will collect plasma samples at baseline, during treatment, and at     progression.   "
87633|NCT02139007|"     This is a pilot study evaluating the recruitment strategies for sites and patients, data     collection instruments, follow-up procedures, administrative processes, and the proposed     management strategy for the future large scale national trial.   "
87634|NCT02138994|"     This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients     diagnosed with a chronic wound. The primary objective is to assess changes in healing rate,     by measuring differences in wound area when treating chronic wounds with the Next Science     Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At     the end of the study period, patients may continue receiving their assigned study treatment     provided they have signed the Continuation of Treatment Informed Consent and the rational     for continuation is documented by the investigator.   "
87635|NCT02138981|"     The purpose of this study is to compare the survival outcomes between hepatic resection and     transarterial lipiodol chemoembolization (TACE) used as the initial treatment in patients     with Resectable Hepatocellular Carcinoma Beyond Milan Criteria.   "
87636|NCT02138968|"     The study intervention improves functional capacity and delays frailty status in pre-frail     elderly subjects.   "
87637|NCT02138955|"     This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer     patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body     surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour     infusion once weekly for 8 weeks.   "
87638|NCT02138942|"     The main objective of this study is to demonstrate that the LIR (Learning Intravenous     Resuscitator) Closed-Loop Fluid Administration System (hereafter the LIR system), a new     device for the automated administration of intravenous fluids during major abominal surgery     and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid),     maintains blood volume at values that are acceptable by the gold standard, i.e. the     anesthetist in charge of the patient.   "
87639|NCT02138929|"     The goal of this clinical research study is to find the highest tolerable dose of LDE225 that     can be given in combination with everolimus to patients with esophageal or GEJ cancer. The     safety of the drug combination will also be studied.   "
87640|NCT02138916|"     The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in     symptomatic patients with moderate to very severe COPD who are receiving standard of care     therapies   "
87641|NCT02138903|"     Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical     ventilation in ICU patients of two French ICU.   "
87642|NCT02138890|"     This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy     of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of     the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g.     physiotherapy, simple analgesics, intra-articular injection).   "
87643|NCT02138877|"     to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an     after coming stent versus stentless pyeloplasty.   "
87644|NCT02138864|"     The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of     Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its     correlation with clinical parameters. This study is expected to be completed in a period of 3     years.   "
87645|NCT02138851|"     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Fig paste on functional constipation. The     investigators measured colon transit time, frequency of defecation, defecation time, stool     type, and abdominal discomfort.   "
87646|NCT02138838|"     The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma     intact parathyroid hormone (iPTH) level by ≥ 30%.   "
87647|NCT02138825|"     To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in     patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic     interstitial pneumonias).   "
87657|NCT02138695|"     1. Purpose of the study      1) To explore clinical recurrence associated clinical factors including age, sex, clinical,     electrophysiological, anatomical, imaging, and serologic characteristics.      2) To develop simulation model to predict clinical recurrence and the efficacy of catheter     ablation 2. Scientific evidence of the study        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed          significant reduction of mortality.        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus          non-drug therapy such as catheter ablation is developed.        3. catheter ablation has been performed for 10years world-wide, and showed superior          treatment outcome compared with drug therapy.        4. clinical outcome after catheter ablation is affected not only by age, sex and underlying          disease, but also by electrophysiologic, imaging, serologic and electroanatomical          remodeling of the heart. However, there are few studies concerning these multifactorial          variables.      3. Study population   "
87658|NCT02138682|"     This investigator initiated trial is designed to measure the accuracy of diagnosis of     Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure     dopamine transporter densities in human tissue. This measurement can assist in distinguishing     between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease,     Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both     clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis     received at time of death. Patients will be registered in the Parkinson Research Institute's     brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain     scanned using DaTscan, and donate their tissue for research and autopsy purposes. The     hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as     accurately as a clinician.   "
87659|NCT02138669|"     The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in     April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters).     Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in     July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use     Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21     CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription     inserts are composed of two clear segments, each having an arc length of 150°, they are     manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are     available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be     implanted depending on the orientation of the cone and the amount of myopia and astigmatism     to be reduced.   "
87660|NCT02138656|"     The purpose of this study is to investigate whether a course of chiropractic treatment has a     significant impact on the natural course of infantile colic, specifically:        1. Do parents of colicky infants randomised to the groups receiving a course of McTimoney          chiropractic treatment:             -  report a significantly greater improvement in hours of crying than those in the               control group?             -  report a significantly greater improvement their own quality of life (anxiety and               depression)?             -  report resolution of colic following treatment than the control group?        2. What effect does parental blinding have on parentally-reported symptoms of infantile          colic and parental quality of life?      The study will also include exploratory investigations to determine whether there are:        1. Any particular groupings of patient characteristics (for example; 'other' presenting          symptoms, position in the natural course of colic, age of onset, spinal dysfunction,          perinatal factors) that are associated with good or poor outcomes        2. Any particular characteristics of the treatment (e.g. specific adjustments) that are          associated with good or poor outcomes.   "
87661|NCT02138643|"     Achalasia is a disorder benign esophageal motor, which is characterized by failure to relax     the lower esophageal sphincter ( LES) in response to swallowing associated with lack of     peristalsis of the esophageal body. Its most common clinical presentation is dysphagia , and     occasionally chest pain , regurgitation , aspiration pneumonia and weight loss , resulting in     a large impact on daily activities and quality of life of affected individuals .      There is currently considered curative treatment for achalasia , dysphagia relief being the     primary therapeutic target and is forced to relax the LES by endoscopy or surgery. Thus , the     most commonly used endoscopic treatments are forced dilatation of the cardia and botulinum     toxin. Laparoscopic Heller myotomy with antireflux procedure with therapy is considered gold     standard  because of excellent results and minimal invasiveness. Currently , pneumatic     dilation and surgical treatment with the Heller myotomy with fundoplication are strongly     associated with the best therapeutic options available .      In recent years, the possibility of using endoluminal access in the treatment of achalasia     patients through the technique originally described as Natural orifices Translumenal     Endoscopic Surgery ( NOTES) and continuing advances in the submucosal dissection has enabled     the concomitant development of a new approach described as perioral endoscopic myotomy . In     2007, Pasricha et al , described the feasibility of endoscopic esophageal myotomy through a     submucosal tunnel initially in an animal model . The first performance of this procedure in     humans was described by Inoue et al , in 2010 , introducing the concept of transluminal     endoscopic surgery through natural orifices , with the objective of minimizing the trauma and     all the stress resulting from open surgical procedure . These authors call the procedure as     POEM ( Per Oral Endoscopic myotomy ) .   "
87662|NCT02138630|"     Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate     increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy     intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for     weight loss supplements. Owing to the fact that these changes are believed to be driven by     catecholamine release and alterations in fat oxidation, there is growing belief that     capsaicin may also offer potential ergogenic benefits (performance enhancement) during     exercise, similar to the affect of caffeine, which works through similar pathways. Of     particular interest are the recent findings that free-fatty acids in the blood are elevated     2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone     indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative     consequences of other stimulants may be avoided. At present, however, more in depth     investigations of the effects on endothelial function, vascular autonomic tone and     inflammation are lacking.      Although there are some indications that capsaicinoid ingestion may alter factors associated     exercise performance (such as increased fat oxidation for glucose sparing), to date these     studies have primarily used very low exercise intensities wherein these effects are typically     unnecessary, and results are not generalizable to the typical race intensities of endurance     sport competition. Performance measures have also been a noticeably absent outcome from     research to date.      Hypotheses: 1), Exercise performance will improve, at a level similar to those demonstrated     for caffeine ingestion 2) ratings of perceived exertion will go down with the effect of     causing intensity to go up 3) During sustained aerobic activity approaching the aerobic     threshold alterations in substrate use will be minimal (but possibly meaningful in regard to     performance); alterations at rest will be more pronounced. 4) acute alterations (6o min post     single dose) in blood pressure, HRV, arterial stiffness and RMR will mirror the effects     observed for more prolonged exposure in phase 1.   "
87872|NCT02135900|"     The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep     apnea syndrome (OSAS).   "
87663|NCT02138617|"     This study involves standard combination chemotherapy treatment for colon cancer,     5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab     (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics     of a person's genetic makeup or genes. Genes are made of DNA and determine not only     inherited traits or appearance (hair and eye color, height, body type, etc.) but also play an     important role in health and how the body responds to illness and treatments for those     illnesses.      In this study, the investigators will examine the relationship between a patient's genes     (DNA), or genotype, and how the patient's body breaks down and removes or metabolizes the     anti-cancer drug irinotecan. Circulating blood level of irinotecan plays an important role in     how well this drug works against a patient's cancer as well as the adverse side effects the     patient may experience. The current standard dose of irinotecan was determined in clinical     trials without knowing individual genotypes and thus does not take into account a patient's     ability to metabolize irinotecan. This means that based on one genotype the current standard     dose of irinotecan may be correct or based on other genotypes the standard dose could result     in lower and possibly less effective blood levels and result in significant under-dosing of     irinotecan.      Based on genotype the patient will be assigned to one of the following doses of irinotecan:        -  180 mg/m2 (standard dose)        -  260 mg/m2        -  310 mg/m2      The purpose of this research study is to determine if dosing irinotecan based on genotype is     effective and safe for patients with colon cancer. Patient genotype will be determined from a     small sample of blood and a laboratory test or assay performed at UNC Laboratories. For the     purpose of this study, this assay is new and considered to be investigational. This means     that the genotype assay used in this study has not yet been approved by the FDA for     determining irinotecan dose levels in patients with colon cancer.   "
87664|NCT02138604|"     Most patients presenting to the emergency department with chest discomfort have a nonischemic     ECG and biomarkers of myocardial necrosis within normal limits. These patients are routinely     admitted to hospital because of diagnostic uncertainty for occult MI or ischaemia.      Acute myocardial ischemia is associated with acute mycardial dysfunction We tested a     non-invasive plethysmographic arterial pressure change index of myocardial performance     (dP/dt) that could be added to the diagnostic triage of ischaemia in the ER avoiding     unnecessary admissions.   "
87665|NCT02138591|"     Vitamin D (Vitamin D) deficiency is very common. We recently showed that 97% of 204 patients     admitted to Truman Medical Center were Vitamin D deficient (<30 ng/ml). However, the     consequences of Vitamin D deficiency, particularly with respect to infection, are not well     understood. It is known that production of cathelicidin, an important antimicrobial peptide,     is critically dependent upon Vitamin D. It is also established that levels of cathelicidin     correlate inversely with urinary tract infection risk. We hypothesize that restoration of     Vitamin D levels to normal in patients undergoing major surgery will result in significant     decreases in levels of perioperative infections due to restoration of normal levels of     circulating Vitamin D, which in turn will elevate cathelicidin levels. As an initial test of     this hypothesis, we propose a double-blind, prospective, randomized study of pre-operative     Vitamin D supplementation. Fifty subjects undergoing surgery will receive daily Vitamin D3     (50,000 IU) for five days pre-operatively, with controls receiving placebo. Levels of Vitamin     D, calcium, cathelicidin, and the pro-inflammatory protein resistin, will be monitored before     Vitamin D supplementation (pre-operatively) and after Vitamin D supplementation     (post-operative days 1 and 2). The effect of these changes should be to decrease the     incidence of infectious complications. We expect to observe Vitamin D levels increase to     normal, and cathelicidin levels become elevated. We expect to see increased levels of     resistin in patients developing infections. This study will provide strong pilot evidence for     future NIH funding.   "
87666|NCT02138578|"     This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide     comparable local control, with similar or improved toxicity rates compared to Radio Frequency     Ablation (RFA) when treating small renal cell carcinomas.   "
87667|NCT02138565|"     Primary hypothesis:      A large reduction in weight is not associated with a change in accurately measured glomerular     filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance     (51Cr-EDTA)).      Secondary hypothesis:      A large reduction in weight is associated with a greater change in estimated GFR (The     Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.      Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology     Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately     measured GFR.   "
87668|NCT02138552|"     The objective of this clinical trial is to identify the most efficacious octenidine     dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo     in the oral cavity.   "
87669|NCT02138539|"     The purpose of this study is to evaluate the effectiveness and tolerability of an herbal     de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to     the other side of the face in treating mottled hyperpigmentation and melasma.   "
87678|NCT02138422|"     The primary objective of this study will be to assess how effective Xilonix is in the     treatment of patients with symptomatic colorectal cancer. By blocking a substance that helps     tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may     improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with colorectal     cancer. The effectiveness of the therapy will be measured by assessing the change in these     symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of     muscle loss will be assessed with a type of X-ray called a DEXA scanner. Improvement in pain,     appetite loss, and fatigue will be measured with a questionnaire that is completed by     patients enrolled on the trial.   "
87670|NCT02138526|"     Pazopanib (Votrient) is registered for the treatment of patients with advanced renal cell     carcinoma and patients with soft tissue sarcoma who have received prior chemotherapy. It is     administered at a fixed oral dose of 800 mg once daily (OD) regardless of size, age and     clinical condition. It is absorbed from the gastrointestinal tract with an oral     bioavailability of ~21%. Pazopanib is practically insoluble and highly permeable. When     ingested with high fat food the pazopanib exposure (area under the concentration time curve     (AUC)) is doubled. Common adverse effects are diarrhea and nausea. This might be caused by     the non-absorbed proportion of pazopanib. A reduced dose taken with food could be a possible     approach to reduce these side effects. Therefore the investigators initially want to     determine the equivalent reduced dose of pazopanib when taken with a continental breakfast.     Thereafter the investigators want to investigate whether the intake with food reduces the     frequently reported side effects nausea and diarrhea.   "
87712|NCT02137980|"     This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who     were participants in the CPORT-E project. The aim of the registry is simple data collection     and reporting to respective State Departments of Health. The registry population consists of     patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without     SOS and who require PCI.   "
87671|NCT02138513|"     Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing     anxiety, depression and fatigue in cancer patients. As this intervention can be offered in     groups, costs are relatively low. In addition, delivering MBCT online might make the     intervention more accessible and cost-effectiveness. However, more information is needed     about what treatment works best for which patient.      Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both     individual MBCT online and MBCT offered as a group training compared to TAU .      Study design: The design of the study will be a multi-centre, randomised, superiority trial,     comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU     condition will be randomised to one of the treatment conditions after 3 months. Main     assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months     after post-treatment (T3).      We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills,     anxiety and depressive compants, psychological well-being, rumination and fear of cancer     recurrence. We also expect the MBCT to result in patients returning to work earlier, have a     higher work ability and have lower medical care costs, thereby being more cost-effective than     TAU.   "
87672|NCT02138500|"     This study will see how PF-06372865, an experimental drug distributes in the brain after one     dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also     evaluate the safety and tolerability of PF-06372865in these subjects and will measure the     level of PF-06372865 in the blood.   "
87673|NCT02138487|"     The investigators are conducting a study to better understand the relationship between     activity restrictions and women's satisfaction following urogynecologic surgery for prolapse.     We hypothesize that women with less stringent postoperative restrictions will have higher     levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic     outcome.   "
87674|NCT02138474|"     Chronic tension-type headaches (CTTHs) affect 30-40% of the population and account for a     number of absences from, and decreased performances at, work and school as well as     recreational activities. CTTHs typically occur at least 15 times a month or at least every     second day, and present as an achy or tight sensation that is felt around the head . The pain     may last from 30 minutes to several days and varies in intensity . Conventional treatment is     palliative, consisting of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs),     which may produce adverse effects and analgesic rebound headaches . Lacticum acidum 30CH is a     homoeopathic remedy that has been shown to have potential benefits in the treatment of CTTHs     . Homaccords are the preparation of one remedy in multiple increasing potencies in a single     vehicle . There has been no research done to date on Lacticum acidum Homaccord in the     treatment of CTTHs.The aim of this study is to determine the efficacy of Lacticum acidum     Homaccord in the treatment of chronic tension-type headaches, using the modified Headache     Diary and the Headache Disability Inventory.   "
87675|NCT02138461|"     This study examines patient perceptions regarding the tolerability of two classes of glaucoma     medication: bimatoprost and latanoprost.   "
87676|NCT02138448|"     Cancer screening can improve the length and quality of life, yet the average American     receives only half of recommended services. Patient-centered personal health records with     higher levels of functionality, combined with practice redesign to make use of these     functions, can help patients obtain recommended cancer screening tests by linking them to     their doctor's records, explaining information in lay language, displaying tailored     recommendations and educational resources, providing logistical support and tools to     stimulate action, and generating reminders. This project will measure whether making these     resources available to primary care practices and patients promotes shared decision-making     and increases the delivery of cancer screening compared to existing information systems.   "
87677|NCT02138435|"     Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If     discovered in infancy or early childhood surgical intervention can be of necessity depending     on the size of the defect, to assure a healthy adulthood. The long-term results of surgical     closure of VSD in childhood are good and after surgery the children are considered as equally     healthy and physically fit as their peers. However, there is inconsistency in data regarding     follow-up on this group of patients, in relation to exercise capacity as a measure of the     cardiopulmonary function. To further approach this matter the post-operative cardiac factors     of these patients have to be investigated.      With this study the investigators intend to examine the long-term outcome on cardiac output     after heart surgery in VSD-patients. It presents an opportunity to also evaluate the     correlation between cardiac output determined by gas-exchange and by MRI. The overall     objectives of this study are to 1) examine whether VSD-operated patients have reduced cardiac     output during exercise in comparison with matched controls, and furthermore 2) to evaluate a     correlation between cardiac output measured by MRI and cardiac output determined by     gas-exchange.      The project is designed as a long-term follow-up and method study. A cohort of 20 children     who in the 1990's underwent surgical closure of a congenital VSD will be asked to participate     in this study. An equal amount of healthy young adults, will function as control group. Each     participant will complete two different exercise tests, a MRI of the heart during lower body     exercise on a supine ergometer bicycle, and a Supine ergometer bicycle exercise test. This     data can be used for comparing cardiac output between the test groups, and furthermore it     allows an evaluation of the correlation between the two methods.      VSD is as described, the most common congenital heart anomaly. If not intervened with in     childhood, it can cause severe heart complications later in life. It is unclear whether this     intervention can cause long-term impact on patients exercise capacity, and for that reason it     is of great importance that we strive for improving our knowledge of the long-term     postsurgical outcome after VSD-closure.   "
87718|NCT02137902|"     This study aims to identify effective and cost-effective interventions for tobacco use and     other risk behaviors for cardiovascular disease among Alaska Native people in rural villages.     In a randomized controlled trial, the study will compare interventions using telemedicine to     promote the American Heart Association's identified ideal health behaviors (nonsmoking and     physical activity) relative to ideal health factors (managing cholesterol and blood     pressure).   "
87719|NCT02137889|"     This study will assess the safety and preliminary efficacy of escalating doses of VAY736 in     relapsed or refractory CLL patients.   "
87680|NCT02138396|"     The objective of this study is to compare the rate of absorption and bioavailability of     fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.   "
87681|NCT02138383|"     The main purpose of this study is to find out the dose of enzalutamide that can be safely     given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.     Researchers also want to find out the side effects of these drugs when given together. This     study will help in finding out the effect on tumor of the combination of enzalutamide,     gemcitabine and nab-paclitaxel. In the first part of the study, different doses of     enzalutamide will be tested. In the second part of the study, all patients will be started at     the same dose of enzalutamide.   "
87682|NCT02138370|"     Surgery still remains the mainstay of treatment for localized colorectal cancer. However,     nearly 30% of patients with localized colorectal cancer (stage II and stage III) will present     with recurrence. Tumor progression is mediated by both intrinsic genetic changes and by     extrinsic epigenetic and host environmental factors, including interactions with the immune     system. Several studies demonstrated that tumor infiltrating memory T-cells and type, density     and location of infiltrating T cells are better predictors of disease-free survival in     patients with CRC compared to the standard TNM staging. These data suggest that tumor     invasion and progression are more accurately predicted by immune response in the primary     tumor. In addition, mismatch repair (MMR)-deficient tumors are characterized a priori by a     higher frequency of tumor infiltrating lymphocytes and are associated with significantly     improved prognosis. Recently, Stotz et al showed that the preoperative lymphocyte to monocyte     ratio in peripheral blood samples predicts clinical outcome in patients with stage III colon     cancer. So far there is no comprehensive analysis of the immune-landscape in CRC.      The aim of the current project is to identify a comprehensive panel of immunomarkers in     localized colorectal cancer (stage II and stage III) applicable for the detection of patients     at high risk of recurrence. For the first time, specific tumor-infiltrating immune cells,     mismatch repair protein expression in tumor tissue and preoperative blood based inflammatory     markers from routine blood counts in corresponding peripheral blood samples and known     clinicopathological features will be correlated with outcome in 300 localized CRC patients.   "
87683|NCT02138357|"     The primary objective of the study is to determine whether Butrans Transdermal System (BTDS)     reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve     to opiate treatment.      The secondary objective of the study is to investigate the effects of BTDS on mood, sleep,     and quality of life.      The study will consist of nine visits. Depending on the need for medication titration, there     may also be two scheduled telephone contacts.      Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who     choose to participate must undergo medication washout as described in the detailed protocol     between visits 1 and 2.      Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and     subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue     medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as     described in the detailed protocol) will be dispensed. Subjects will begin treatment period     #1 immediately after this. The study medication will be titrated within the allowed range     according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone     contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome     measures for the first treatment period. Visit 5 will also mark the beginning of the second     treatment period.      Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those     described above during treatment period #1. Visit 8 will mark the end of the second treatment     period during which outcome measures will be ascertained.      Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two     weeks after visit 8 for review of adverse events.   "
87684|NCT02138344|"     Development of neuropathic pain is one of the most disabling sequels after spinal cord injury     (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as     well as its plastic changes following SCI can be assessed in vivo by surface     electrophysiological recordings and functional magnetic resonance imaging after noxious heat     stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the pain     pathway and characterizing its changes as a consequence of SCI and in peripheral nerve     diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI     patients with neuropathic pain and in patients with peripheral nerve diseases and relating     them to the development of neuropathic pain syndromes.   "
87685|NCT02138331|"     Type 1 diabetes mellitus is strictly autoimmune mediated disease destructing the islets     β-cell of the pancreas. Mesenchymal stem cells and its microvesicles are reported as an     anti-inflammatory agents. We hypothesis that intravenous infusion of cell free umbilical     cord-blood derived MSC microvesicles may reduce the inflammatory state and hence improve the     β-cell mass as well as the glycemic control of the patients of T1DM.   "
87694|NCT02138214|"     This randomized phase II trial studies how well thyroid gland removal with or without central     lymph node dissection works in treating patients with thyroid cancer or suspected thyroid     cancer that has not spread to the lymph nodes. Currently, the standard treatment for thyroid     cancer is total thyroidectomy, or complete removal of the thyroid. Sometimes, the lymph nodes     in the central part of the neck may also be surgically removed, called central lymph node     dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening     complications, and may reduce post-surgery quality of life. It may also prevent the cancer     from returning and reduce the need for additional surgery. It is not yet known whether     recurrence rates and complication levels are lower after thyroid gland removal alone or with     central lymph node dissection.   "
87686|NCT02138318|"     Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC)     compared to the general population. Regular screening by colonoscopy is an internationally     recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon     has been the mainstay of conventional surveillance practice to detect abnormalities, known as     dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and     processed, a practice which is is tedious, expensive, time consuming and has a low pickup     rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with standard     conventional white light colonoscopy (WLC).      Detection can be improved by the application of dyes which highlight more subtle     abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia     detection but more time consuming for the patient and cannot guarantee that the whole colon     is covered. CE has only been compared in clinical trials with standard definition endoscopy     rather than the recently available high definition endoscopes with better resolution and     picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution     CCD (charge coupled device) providing much better images than standard video endoscopy. HD     colonoscopy promises therefore to provide an alternative to CE in UC surveillance without the     need for the extra time and experience required for dye spraying for both endoscopists and     nursing staff.      The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to     chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for     ulcerative colitis. There have been no trials comparing these two modalities and the     investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy     would be marginal and therefore CE would be reserved for procedures using standard definition     scopes.   "
87873|NCT02135887|"     This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate     efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules     tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their     primary tumor.   "
87687|NCT02138305|"     Visual assessment of a coronary artery narrowing (called stenosis) seen on angiography is     conventionally used to infer how likely the stenosis will limit blood flow (called ischemia)     under conditions of increased demand (e.g exercise). This is based on animal work and data     from humans with simple single vessel disease with no co-existing conditions. These data have     been extrapolated to more complex patients/ complex disease but clearly over-simplifies the     situation in the majority of patients cardiologists treat.      Pivotal work by DeBruyne, Pils and colleagues in the 90's convincingly showed that pressure     derived measurements, called FFR, from the coronary artery during a cardiac catheterization,     more accurately identify stenoses that would cause ischemia compared to visual assessment     alone. A strategy of FFR guided coronary stenting with drug eluting stents significantly     improved outcomes and reduced costs compared to visual assessment alone (FAME trial).     Deferring treatment based on FFR has been shown to be safe (DEFER Trial). FFR has excellent     sensitivity and specificity. A FFR of <=0.80 was used as this identified ischemia causing     lesions 90% of the time. Therefore, the concept of FFR guided percutaneous revascularisation     and treatment deferral has a robust evidence base to support it.      Coronary bypass grafting (CABG) is traditionally based solely on a visual assessment of     angiography images. SPY® Infrared Fluorescence Angiography (NIRF, FDA approved 2005) is used     by some cardiac surgeons to assess the patency of bypass grafts in real-time in the operating     room, as a surrogate for immediate traditional coronary angiography. Dr. Ferguson observed     that regional myocardial perfusion (RMP) image data was also captured in these video     sequences.      Study Hypotheses:        1. In patients who are likely CABG candidates, target vessel epicardial coronary arteries          (TVECAs) with FFR > 0.80 will not demonstrate an increase in RMP despite an anatomically          patent bypass conduit during SPY® imaging.        2. In TVECAs with an increase in RMP during SPY® imaging, cardiac catheter laboratory          measures of coronary physiology from that TVECA, namely one or a combination of FFR,          CFR, HSR and HMR, will correlate with the SPY® data on myocardial perfusion, and suggest          a potential mechanism for this physiologic response to TVECA grafting.   "
87688|NCT02138292|"     The study is a prospective, single-arm, one-site therapeutic trial of the combination of     trametinib plus digoxin for advanced melanoma. endpoints are toxicities assessed by nCi CTCae     v4.1 within the first 8 weeks, responses measured by ReCiST v1.1 criteria every 8 weeks with     scans and exams, tumor sensitivity to the drug combination quantified by tumor regressions in     nSG mice, and correlations of response with tumor sensitivity, BRaF status, MaPK inhibitor     exposure history, and tumor sodium pump expression.      Treatment Dosage and administration      Study Drugs:        1. Trametinib (2mg) will be administered orally on a daily basis.        2. Digoxin (0.25mg) will be administered orally on a daily basis.      on a 8-week cycle, duration of treatment can last from 8 to 104 weeks.      endpoints        1. Toxicities will be assessed via nCi's CTCae v4.1 toxicity criteria. DLTs will be defined          based on the rate of drug-related (definitely or probably) grade 3-5 adverse events          experienced within the first 8 weeks of study treatment. The MTD will be exceeded if          more than 20% of patients on the study experience DLTs.        2. Responses will be measured by ReCiST v1.1 every 8 weeks. Response duration will be          defined as time from first documented response until disease progression. PFS is time          from treatment until disease progression.        3. Patient tumor sensitivity to the drug combination will be quantified by the amount of          subcutaneous established tumor growth inhibition in nSG mice by 5d/week oral gavage with          drugs.        4. Tumor nRaS status will be determined by tumor Dna extraction, PCR amplification of exons          and Sanger sequencing of nRaS.        5. History of prior MaPK inhibitor therapies will document MeK inhibitor exposures.        6. Sodium pump subunit expression will be analyzed by pretreatment tumor          immunohistochemistry and a qualitative 0 to 3+ grading system.   "
87689|NCT02138279|"     The primary objective of this clinical study is to collect clinical data to support FDA     510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The     secondary objective is to evaluate any adverse events found during the clinical study.   "
87690|NCT02138266|"     The primary objective of this clinical study is to collect clinical data to support an FDA     510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to     evaluate any adverse events found during the clinical study.   "
87691|NCT02138253|"     This is a double-blind, multicenter study involving patients with chronic HCV infection who     had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete     cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but     still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with     IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the     new liver caused by HCV.   "
87692|NCT02138240|"     The 1.2 million households living in public housing are disproportionately affected by     obesity, where prevalence is estimated at 50%. An ecologic framework hypothesizes that this     disparity is related, in part, to social and environmental factors within these neighborhoods     that influence residents' lifestyles. Social networks and the built environment may work     together to promote or inhibit lifestyle behaviors; however, combined social network-built     environment interventions have not previously targeted changes in diet. We hypothesize that     an intervention that combines a social network approach with strategies that address public     housing residents' challenges related to the built environment will improve dietary habits.     Our overall aim is to develop a combined social network-built environment intervention to     reduce intake of beverages high in added sugars and to pilot test the intervention among     residents of public housing developments in Baltimore, MD. Our aim for this work is: 1) To     develop a combined social network-built environment intervention to reduce intake of     beverages high in added sugars and to pilot test the intervention among residents of public     housing developments in Baltimore, MD. We hypothesize that a social network intervention will     be feasible and acceptable in promoting healthy lifestyle change, and that this intervention     will alter lifestyle behaviors among public housing residents.   "
87693|NCT02138227|"     The purpose of this study is to evaluate the efficacy and generalizability of a communication     intervention (Communication Effectively about Donation (CEaD)) for Organ Procurement     Organization (OPO) staff requesters and to compare two conditions of delivering the CEaD. The     experimental design will test: (1) the overall efficacy of the intervention on timely     referral and consent for organ donation and (2) whether a completely autonomous condition (no     outside training assistance) is clinically equivalent to the assisted condition (training     provided by outside consultants) in terms of the final outcome of consent to donation.   "
87695|NCT02138201|"     The exact innervation of the bladder and the changes after a spinal cord injury have been not     yet been illustrated.      Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used     to visualize single nerve fibers, and thus represent the neural supply of a region in vivo.     There are studies in which both the sacral plexus and the lumbar nerve roots have been     represented using diffusion tensor imaging. However, there is no study concerning the     innervation of the bladder.      The investigators are therefore using diffusion tensor imaging with magnetic resonance     imaging to represent the bladder innervation of individuals with neurogenic lower urinary     tract dysfunction and individuals with normal bladder function.   "
87696|NCT02138188|"     The Continuous Subcutaneous Insulin Infusion (CSII) might have an impact on psychological     distress and some psychological factors might be predictors of metabolic control; however,     very few studies conducted so far were specifically focused on the psychological aspects of     CSII therapy in adults affected by T1DM.   "
87874|NCT02135874|"     The goal of this clinical research study is to learn if the combination of clofarabine,     idarubicin, cytarabine, vincristine, and dexamethasone, with or without rituximab, can help     to control mixed phenotype acute leukemia. The safety of this combination will also be     studied.   "
87697|NCT02138175|"     The purpose of the study is to determine whether noninvasive hemoglobin monitoring is     sensitive and accurate enough to detect a significant downward trend in hemoglobin in     patients at risk for significant bleeding. If this can be shown, it has the potential to     spare patients multiple invasive blood draws as well as allow for earlier detection of     significant blood loss and therefore positively impact on patient morbidity and mortality.     Additionally, it may represent significant financial cost savings in that it may allow for     patients to be monitored in a non-intensive care unit setting.      This will be an observational study. The continuous hemoglobin monitor will be connected to     the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin     monitoring will occur concurrently at a pre-specified frequency as well as at the physician's     discretion based on usual clinical information. The physician will be blinded to the     continuous hemoglobin monitoring readings and therefore patient care will not be affected by     the use of the monitor. Once the study has ended, the data will then be analyzed to assess     for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin     measurement.   "
87698|NCT02138162|"     The influence of severely diminished liver function on the metabolism, safety, and     tolerability of a single oral dose of enzalutamide in a group of 8 men. The results are     compared to the data gained from 8 age- and BMI-matched men with normal liver function.   "
87699|NCT02138149|"     Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this     bladder dysfunction, individuals with SCI have to undergo regular invasive examination of     their bladder function (urodynamic examination).      The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there     are reports, that the concentration of NGF is elevated in the urine of patients with bladder     dysfunction. The NGF concentration can also be measured in the blood. The concentration of     NGF in the blood and urine of SCI individuals has not yet been investigated. These     concentrations may correlate with the severity of bladder dysfunction, and may thus be used     to replace or at least reduce the number of the more invasive urodynamic examinations.      The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher     compared to individuals with healthy bladder function will be tested.   "
87700|NCT02138136|"     A study of the long-term safety and efficacy of Lubiprostone in subjects aged ≥ 6 to < 18     years diagnosed with Functional Constipation   "
87701|NCT02138123|"     In this study, the investigators introduce a surgical procedure called IOL-shell technique     in the purpose of reduce complications of surgeries for dense cataract, and report a     prospective randomized controlled study aiming at assessing efficacy and safety of the     IOL-shell technique, which showed that the new procedure offered a safer way for hard     cataract surgery over the conventional phacoemulsification procedure without compromise in     efficacy.   "
87702|NCT02138110|"     -  To evaluate whether the Scaffold is safe and demonstrates probable benefit for the          treatment of complete T2-T12/L1 spinal cord injury .        -  This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate          safety and probable benefit in support of future studies and an HDE application with          subsequent approval.   "
87703|NCT02138097|"     This protocol is for a series of descriptive analyses conducted within a cohort of patients     using linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, and other oral and     non-insulin injected hypoglycemic medications between May 2011 and July 2012.      Understanding 1) the existing utilization patterns for linagliptin, sitagliptin, saxagliptin,     and other oral and non-insulin injected hypoglycemic agents and (2) the differences in     utilization patterns between these agents will help with the design, analysis and     interpretation of comparative effectiveness and safety studies of linagliptin, other DPP-4     inhibitors, and other agents.      The study will provide an overview of existing utilization patterns for linagliptin, other     dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic     agents, in order to detect potential selective prescribing patterns that might lead to     channeling bias.   "
87704|NCT02138084|"     The purpose of this study is to provide dosing recommendations for the coadministration of     BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for     prescribing information purposes   "
87705|NCT02138071|"     The purpose of the study is to determent whether there is a difference between two types of     treatments in physiotherapy (individual vs group) for patients with low back pain (LBP), in     terms of their sensation of how they have been helped and their treatments' outcomes     measures. The study hypothesizes are: a) Based on the results of literature review which does     not reveal a clear difference between group and individual treatments' outcomes for LBP, it     is hypothesized that no difference will be found in treatment results for the two types of     group treatments in the present study also, b) The assumption is that different distribution     of therapeutic factors will be found in the two types of treatments (individual, group), C)     Patients' sensation of how they have been helped will be connected to treatment results.   "
87706|NCT02138058|"     It is a double blind controlled study to test the hypothesis that Topiramate is more     effective than placebo in the treatment of compulsive buying, during a period of 12 weeks   "
87707|NCT02138045|"     The purpose of this trial is to explore whether liraglutide has a long term effect on     clinical symptoms and biomarkers in patients with diabetic neuropathy.   "
87708|NCT02138032|"     Message framing involves the presentation of choice alternatives, either in a positive or     negative manner (Huber, Neale, & Northcraft, 1987; p.137). Positively framed health messages     contain potential gains of participating/refraining in specific health behaviour.     Alternatively, negatively framed health messages contain potential losses of     participating/refraining in specific health behaviour (Verlhiac, Chappe, & Meyer, 2011). The     primary aim and rationale of this study will be to investigate which type of framing has the     greatest effect on intentions to quit smoking in patients with vascular arterial disease. The     secondary aim is to investigate what other factors may have an effect on intention to quit     and also what factors play a part in a patient's intention to quit smoking.   "
88571|NCT02126748|"     The purpose of this study is to investigate the effectiveness of two airway clearance     techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in     hospitalized infants under the age of 2 with acute viral bronchiolitis.   "
87713|NCT02137967|"     Formocresol (FC) is the most universally taught and most widely used pulpotomy medicament in     the primary teeth. However, concerns have been raised over the use of FC because of its     toxicity and potential carcinogenicity. A substitution for FC has been investigated but     evidence is lacking to conclude which is the most appropriate technique for pulpotomies in     primary teeth. Sodium hypochlorite (NaOCl) has been used in root canal irrigant for more than     80 years, and it is at present the most popular irrigant in root canal treatment. Studies     have showed that NaOCl is biological compatible and is a very good antimicrobial solution     without being a pulpal irritant. Recent studies using sodium hypochlorite as pulpotomy     medicament in primary molars showed promising results. In this project, the investigators     propose a randomized clinical trial, which will be performed in Pediatric Dentistry     Department of the National Taiwan University Hospital, to compare the treatment outcomes     between NaOCl and FC in human primary molars needing pulpotomy treatment. The aim of this     sudy is to determining weather NaOCl is a suitable replacement for FC in the pulpotomy of     human primary molar teeth. To assess this aim, 200 healthy children from 2.5 to 9 year-old,     who have at least one primary first or second molars diagnosed to receive pulpotomy treatment     will be recruited in this project. The involved teeth will be randomly assigned to the     control group (dilute 20% Formocresol (DFC)) or experimental group (2.5% NaOCl). At 3, 6, 9,     12, 15, 18, 21 and 24 months post-treatment, the randomly assigned teeth will be clinically     and radiographically evaluated by blinded independent evaluators to the treatment group. The     differences will be statistically analyzed using chi-square test, Fisher exact test, and     t-test, using a statistical significance at p<0.05.   "
87714|NCT02137954|"     This is a multicenter, prospective, randomized, placebo-controlled, double-blind,     two-parallel groups study comparing lidocaine (experimental group) to placebo (control     group). The study protocol was elaborated using the recommendations of the Consolidated     Standards of Reporting Trials (CONSORT) Statement.   "
87715|NCT02137941|"     Chronic stress at work is a public health problem increasing morbidity and mortality,     especially in men. Among the men military populations, the firefighters of Paris (FFPs) are     particularly exposed. To deal with this stress and to improve stress management is     challenging. Psychological fitness is required to regulate emotions which improve     effectiveness under stress and enhance recovery from stressful events. The heart coherence     (HC) program uses feedback from a simple pulse sensor to reflect changes of the     emotional/psychological state, and to learn how to reduce stress and stabilize emotions.     Another kind of psychological fitness focuses on cognitive training to regulate emotions,     with the use of techniques to optimize potential (TOP). The TOP consists of learning easy     techniques in mental skills to improve cognitive-based problem-solving using respiration,     relaxation, and visualization. Although never published in a peer-review journal, the     procedure of TOP training is structured and standardized for individuals and groups, and is     widely practiced in air traffic controllers, with apparently good effects.      Moreover, any event can be emotionally ambiguous, providing both negative and positive     outcomes. The interpretation of such ambiguity is linked with an individual's emotional     state, such as anxiety or mood. Individuals with a high level of trait anxiety are likely to     interpret an event negatively.      However, no studies have compared the effect of HC or TOP in the perceived stress of FFPs.     Nor have long-term effects of these stress management programs (SMP) been investigated.     Furthermore, the influence of trait anxiety on stress levels in FFPs needs to be clarified.     Finally, no trials have assessed levels of biomarkers stress following these SMP.      From these observations, we hypothesized that 1) young recruits aiming to become FFPs will be     particularly exposed to stress, 2) SMP will be effective in reducing perceived stress, 3) SMP     will mainly benefit FFPs who have high anxiety, and 4) the effects of SMP will lower levels     of biomarkers of stress.      The aim of this randomized control trial is to evaluate the effectiveness of stress     management programs on perceived stress (primary outcome variable), and on negative mood,     mindfulness, and biomarkers of stress (secondary outcome variables) in FFPs. We also aim to     investigate the influence of anxiety on the stress management programs effectiveness     long-term.   "
87716|NCT02137928|"     This study will evaluate the clinical efficacy of periocular injections of carboplatin     together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy     alone.   "
87717|NCT02137915|"     This study is being done to determine the long-term safety and possible benefits of     transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic     Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to     those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part     of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term     follow-up study.   "
87783|NCT02137057|"     Cardiac autonomic neuropathy is a common complication of diabetes and is associated with     resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by central     sympathetic blockade. The investigators evaluate the relation of severity of diabetes and     heart rate variability, also the impact of spinal anesthesia on the change of heart rate     variability.   "
87720|NCT02137876|"     This study is being done to better understand how immunosuppressive medications     (anti-rejection medications that may or may not be approved by the Food and Drug     Administration (FDA)) affect the alloimmune response (how a person's immune system reacts     against another person's immune system). This will be determined by the blood tests run on     the patients donated blood cells.      Specifically, the investigators will test different immunosuppression medications using     in-vitro assays (in the laboratory, in test tubes) alone and/or in combination to test how     they can affect B-cell proliferation and differentiation, leading to an altered distribution     among defined B-cell subsets and to study if exposure of B cells to thymoglobulin can have     effects on subsequent interaction between B and T cell in vitro.      To enable the investigators to understand how immunosuppressant medications affect immune     systems in transplant patients, the investigators need to understand how they affect immune     systems in healthy people. To do this, the investigators will need to study blood collected     from healthy volunteers.   "
87721|NCT02137863|"     The aim of this study was to evaluate the effects of dexmedetomidine on renal function,     hormonal and hemodynamic parameters in contrast media induced diabetic patients.   "
87722|NCT02137850|"     This trial is conducted globally. The aim of the trial is to investigate the safety and     efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with     haemophilia A.   "
87723|NCT02137837|"     This randomized Phase III trial studies how well the combination of fulvestrant and     everolimus together or the combination of anastrozole, fulvestrant and everolimus together,     improve progression-free survival (PFS) versus fulvestrant alone.   "
87724|NCT02137824|"     The aim of the present study is to establish a modified minimally invasive surgical technique     for sinus floor augmentation with a residual bone height of 3-6mm.      Hypothesis: The investigators expect that the present surgical technique allows to achieve an     adequate implant bed of at least 10mm height after a healing period of 3-5 months. Further     the modification of the technique enables a reduced patient stress level.   "
87725|NCT02137811|"     Recently an automated test for measuring cancer cell death in the presence of chemotherapy     has been developed. This test has been called the MiCK assay during the ten year development     phase and is now called Correct Chemo.      CorrectChemo provides the medical community and patients a way to determine the effects of     different chemotherapies on individual cancer cells.      MiCK assay has been proven to have clinical usefulness in two studies. In one study using     multiple types of cancer, physicians used the MiCK assay in 63% of the patients. If the     physician used the results to prescribe the chemotherapy treatment, the patients' response     rate, time to the disease getting worse, and overall survival were all significantly better     compared to patients whose physicians did not use the results. In another study of breast     cancer patients, physicians used the MiCK assay in 74% of patients. If the results were used     when planning chemotherapy, response rate and time to the disease started getting worse were     all significantly better compared to patients whose physicians did not use the results of the     MiCK assay The purpose of this study is to compare the outcomes of patients who have had the     MiCK assay (CorrectChemo) with tumor types, physician attitudes towards the test, and how the     physicians used the test. This study will be gathering this data by reviewing medical charts.   "
87726|NCT02137798|"     To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in     patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional     electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping     system without fluoroscopy image integration   "
87727|NCT02137785|"     The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and     effective in the treatment of actinic keratoses on the upper arms and hands   "
87728|NCT02137772|"     The study will evaluate the efficacy and safety of MK-8228 for the prevention of     clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic     hematopoietic stem cell transplant. The hypothesis being tested is that MK-8228 is superior     to placebo in the prevention of clinically-significant CMV infection through 24 weeks after     transplant.   "
87729|NCT02137759|"     In the first phase of this study (Cohort 1), the investigators will determine the feasibility     of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with standard RT/TMZ     and determine whether magnetic resonance spectroscopic imaging (MRSI) can predict for better     outcomes in these patients. In the second phase of this study (Cohorts 2a and 2b), the     investigators will find the maximum tolerated dose of belinostat for treating newly-diagnosed     GBM patients with standard RT/TMZ and will determine whether MRSI can aid clinicians in the     early determination of response to this new therapy.   "
87730|NCT02137746|"     The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in     patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an     objective progression of the disease.   "
87731|NCT02137733|"     The purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol     by evaluating tolerability (The probability that administered maintenance dose reaches the     maximum will be determined as an indicator) as a primary endpoint when bisoprolol or     carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In     addition, the safety and efficacy of bisoprolol will be investigated.   "
87732|NCT02137720|"     The goal of this study is to evaluate the implementation and effectiveness of an intervention     to improve diabetes self-management, emotional distress and metabolic control among adults     with type 2 diabetes receiving care in primary care practices throughout New York City. The     program will be implemented by the New York City Department of Health, through their Primary     Care Improvement Project.   "
87733|NCT02137707|"     This study will determine whether in RRMS patients receiving Gilenya there is a link between     disease progression and biologic markers.   "
87784|NCT02137044|"     The purpose of this study is to: (1) test the benefits of the patient-centered collaborative     care treatment approach for persons with MS who also have depression and/or pain; and also     (2) test whether this approach improves quality of life, patient satisfaction, adherence to     other treatments, and quality of care in the MS care system.   "
88686|NCT02125253|"     To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal     Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal     Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis   "
87734|NCT02137694|"     Auto-takings by APU and vaginal APV during the consultations for FCU in the department of     gynecology-obstetrics (Group 1) according to an instructions for use proposed to the     inclusive women, with consent; the same proposal, APU and APV, is made for other     consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology,     ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the     laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results     transmitted to the women and to the doctors of consultation. In case of positive test (15 %),     the patients are directed to a gynecologist. Confrontation with the cytological data when     available (Group 1) .   "
87735|NCT02137681|"     The project was undertaking by Qilu Hospital, Shandong University and other several     well-known hospitals in China. In order to report the efficacy and safety of Rituximab in     different frequencies for the treatment of adults with steroid-resistant/relapsed immune     thrombocytopenia (ITP).   "
87736|NCT02137668|"     The purpose of this study is twofold. First, is to determine whether vancomycin is effective     in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and     if so, by what mechanism. Secondly, to characterize human intestinal microbial communities     and their interactions with the host.   "
87737|NCT02137655|"     The development and implementation of fast-track principles in total knee and hip     arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of     hospital stay. This without a concomitant increase in morbidity or readmissions for medical     or surgical complications and with reduced mortality. However, only little is known about     function in the subacute period after arthroplasty, and there is a need for further data on     physical and psychological functioning following discharge from hospital.This to ensure, that     the positive results from the perioperative setting are carried forward in the subacute     phase.   "
87738|NCT02137642|"     The purpose of this study is to evaluate safety and tolerability as well as the effects of     RM-131 on colonic motor and sensory effects in patients with chronic constipation.   "
87739|NCT02137629|"     The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety     information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved     package insert, after approval of marketing authorization for new drug in Korea. In addition,     the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE     is a prospective, multi-centre, observational, non-interventional, post-marketing     surveillance. At least 600 patients' data that is eligible for safety assessment will be     collected.      VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)      /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug     Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors     influencing safety & efficacy of the drug. It is necessary to examine patients' demographics     and baseline characteristics, medical history, status of VIDAZA treatment, concomitant     medication and evaluation of safety and final efficacy (best response) assessment.   "
87740|NCT02137616|"     This study assess the safety and effects of atypical antipsychotics in subjects with     psychosis syndrome and psychosis risk syndrome.   "
87741|NCT02137603|"     The literature has reported that fast track surgery can be safely applied to children     undergoing appendectomy for acute appendicitis. There is no current evidence regarding the     application of same day discharge protocol in children with intra-operative findings of     suppurative appendicitis. The current standard of care for patients who present with     intra-operative findings of suppurative appendicitis includes post-operative admission and     treatment with intravenous antibiotics. Patients are discharged home once they have met the     following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with     oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that     has shown that same day discharge of patients with acute appendicitis is safe and effective,     we propose that fast track surgery protocol can be safely applied to patients with     intraoperative findings of suppurative appendicitis. We hypothesize that this will result in     a decreased postoperative length of stay, without an increase in 30-day complication rate.   "
87742|NCT02137590|"     This study will investigate the effect of Spanish Black Radish on phase I and phase II enzyme     activity in healthy adult males. The primary objective is to determine the effect on phase I     and phase II enzyme activity by measuring plasma and urine acetaminophen metabolite     concentrations prior to and after a 28 day supplementation period with Spanish black radish     product.   "
87743|NCT02137577|"     The purpose of this study is to determine whether DEB is more effective than common PTA     balloon using under in long-term vessel patency and inhibiting restenosis in the     infrapopliteal artery.   "
87744|NCT02137564|"     This phase II trial studies the effects, good and bad, of gamma secretase inhibitor     PF-03084014 and to see how well it works in treating patients with acquired immune deficiency     virus (AIDS)-associated Kaposi sarcoma. Gamma secretase inhibitor PF-03084014 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth and may shrink     the tumor.   "
87745|NCT02137551|"     The primary objective of the study is to evaluate how engaging ACO beneficiaries in the     appointment based model for one year impacts medication adherence and healthcare costs     compared to usual care.   "
87746|NCT02137538|"     The purpose of the study is to determine if there are differences in the final height or     hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now     routinely used to increase stature: Anastrozole and Letrozole. It also should determine if     there are differences in the side effect profiles of the two drugs to be used.   "
87747|NCT02137525|"     This study will explore effectiveness of three doses of fentanyl sublingual spray against an     active comparator in emergency department (ED) patients with acute pain.      After screening, eligible participants will participate in a treatment period (up to 2 hours)     and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label     standard of care rescue medication for pain can be given at any time during the study period,     based on clinical judgment of the treating physician.      Adverse events will be collected for five days after initial enrollment.   "
88687|NCT02125240|"     The purpose of this study is to compare 2 years of disease-free survival (DFS) of Icotinib     and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung     adenocarcinoma.   "
87748|NCT02137512|"     The purpose of this study is to see if an automated insulin management system (study     system) can safely be used at home to manage blood sugar. The study system includes (1) a     CGM that measures glucose levels, (2) a computer program on a smartphone that determines how     much insulin is needed and allows the study participant user to control the whole system, and     (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be     from Roche. The CGM and pump are similar to the devices that are currently available for     people to purchase and use. However, the smartphone device, the CGM sensor type used with it,     and the overall study system can only be used for research at this time.      The study will be completed by about 24 individuals at 6 centers in the United States and     Europe. This study has several phases and will take about 11-14 weeks to complete depending     on whether the study participant is a CGM user or not.      At selected sites (based on subject eligibility and availability), approximately 10-20     subjects who exhibit safe and competent use of the system at home will be given the option to     continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.   "
87749|NCT02137499|"     The investigators will be evaluating the immediate and longer term effect of treatment with a     medical device on the symptoms of chronic venous disease.   "
87797|NCT02136875|"     The purpose of this pilot study is to determine whether early treatment of acute     exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy,     Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known     as the conventional treatment.      Primary objective: To determine whether early treatment with combination therapy (SFP) can     reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.      Secondary objectives:        -  To evaluate the feasibility of this treatment approach and to provide pilot data (needed          for a larger multi-centre clinical trial;        -  To evaluate the feasibility and need of assessment during and after exacerbation onset,          health-related quality of life and physical activity;        -  To evaluate the safety of this approach; this is in terms of the delay in starting          prednisone and an unfavourable outcome (ER visits and/or hospitalization).   "
87750|NCT02137486|"     Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis.     Their structural properties make angioplasty technique to increase the difficulty of     implementation, but also increased the risks of the in-stent thrombosis and restenosis.     Standard treatment of coronary bifurcation lesions remains controversial manner, especially     when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex     procedures and certain types of lesions are associated with poor prognosis. There is no     standard treatment for such lesions even with the development of drug-eluting stents solve     partial problems. The investigators reviewed patients who received coronary intervention     between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic     relevance of these cases the use of different treatment modalities.      We introduced a retrospective analysis for high angulated bifurcation lesions with     intermediate to high complexity(SYNTAX>22) treated with either DES or BMS.      Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time,     fluoroscopy time, procedure success, angiographic success.   "
87751|NCT02137473|"     Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal     nutrient reserves and elevated nutritional requirements which may contribute to poor outcome.     Adding nutrients to human milk improves their nutritional status and growth, but it is     unclear if adding bovine protein-based fortifiers as is the current standard of care has some     unintended negative consequences to neonates. Infants will be randomized to have their feeds     (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based     fortifier or a bovine protein-based fortifier and will be followed in hospital to assess     feeding tolerance, growth, gut inflammation, gut microbiome, and neonatal morbidity and     mortality.   "
87752|NCT02137460|"     This is a prospective cohort study for cognitively normal (young and old), mild cognitive     impairment, and Alzheimer's disease people   "
87753|NCT02137447|"     The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in     high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).      Hypothesis:      Historically, the average rates of infective complications in surgical wounds types are 7.7%     in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena     ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce     these rates by 50%.   "
87754|NCT02137434|"     The purpose of the study is to investigate calcium acute influence over the postprandial     effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure,     oxidative stress, and endothelial function in obese women.   "
87755|NCT02137421|"     The aim of this study is to explore the role of Canonical β-catenin/Wnt and forkhead box O     (FOXO) pathways by means of investigating their target genes in coronary artery disease (CAD)     pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD     patients.   "
87756|NCT02137408|"     The Investigator would like to see if taking a DHA supplement at a dose recommended for heart     health will improve brachial artery dilation (relaxation) and help blood pressure. As a     second goal the Investigator would like to see if this supplement can delay preterm delivery     by improving heart health. In this research study, the Investigator is asking pregnant women     with chronic high blood pressure to take Expecta (DHA - Martek Biosciences, now known as DSM     Nutritional Lipil) during the last half of their pregnancy until six weeks after they deliver     their baby.   "
87757|NCT02137395|"     The purpose of this study is to determine whether dexamethasone extends the duration of     recovery from anesthesia.   "
87758|NCT02137382|"     maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion     of fat, sugars and proteins) in Cystic Fibrosis   "
87759|NCT02137369|"     While there are many effective options for treating a major depressive episode, there are no     clinical markers that predict the likelihood of remission with an initial trial of either an     antidepressant medication or psychotherapy. The goal of this study is to test how brain     function changes in depress patients treated with cognitive behavioral therapy (CBT) compared     to patients treated with escitalopram ((s-CIT) - Lexapro®), an FDA approved antidepressant.     The study aims to determine if bran scan findings might help physicians to select the most     effective antidepressant treatment for an individual patient.      At total of 150 male and female outpatients who are between 21-55 years old will be enrolled.     Participation in the study will last from 14-26 weeks.      Subjects will be randomized to receive either escitalopram (s-CIT) or CBT for 12 weeks.     Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance     imaging (fMRI) scans will be done before the treatment begins, and again at the end of     treatment (week 12). Non-responders to s-cIT or CBT will be crossed over to receive an     additional 12 weeks of treatment with the alternative intervention.   "
88102|NCT02132884|"     This randomized clinical trial studies how well genetic sequencing-informed targeted therapy     works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is     a type of treatment that uses drugs or other substances to identify and attack specific types     of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify     these specific types of tumor cells in patients with non-small cell lung cancer.   "
87760|NCT02137356|"     Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally     treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This     treatment is associated with only a 15-20% pathological complete response. Selinexor     (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has     demonstrated radiosensitization with in vivo models and has suggested single agent activity     against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard     chemoradiation combined with Selinexor.      We hypothesize that tumors treated with this new combination will demonstrate an increased     response rate compared to those treated with capecitabine-radiation alone.   "
87761|NCT02137343|"     This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of     Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal     epithelial transition factor (MET)-positive gastric or gastroesophageal junction     adenocarcinoma (GEJ).   "
88698|NCT02125097|"     The purpose of this clinical investigation is to evaluate the safety and effectiveness of the     Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch     intracranial aneurysms with any approved embolic coils.   "
87762|NCT02137330|"     The ongoing global rise in the prevalence of overweight and obesity among all ages and among     all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher     incidence in serious health risks, already present at an early age, switching-on the engine     towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to     avoid systemic and cardiovascular complications of obesity.      Weight loss devices have been recently introduced in bariatric surgery, also in children.     They mostly require invasive procedures to be applied. Mini-invasive devices would be needed     to obtain weight loss in the pediatric population, since the early age of involved patients.      Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air,     and have been used to induce weight loss in obese adults. The investigators aimed to perform     a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters     modifications, after up-to-3 Obalon® Gastric Balloons placement.   "
87763|NCT02137317|"     According to the World Health Organization pesticide poisoning is a major health problem due     to the millions of cases annually occurring worldwide. Farmers have a particularly high risk     of pesticide poisoning because of their work involving pesticide use to protect crops. The     majority of pesticide poisonings occur in developing countries. On a short term it is not     realistic to reduce farmers' use of pesticides significantly because it would require that     secure and cost-effective alternatives are introduced. This is a lengthy process, which     should undoubtedly be supported. However, it becomes as important to make sure that farmers     can protect themselves from pesticide exposure meanwhile. Use of personal protective     equipment can minimize pesticide exposure on farmers' bodies and consequently reduce their     risk of pesticide poisoning. However, the sparse research identified through a systematic     literature review shows that we are not in a position to give recommendations on what     personal protective equipment farmers should protect themselves with against pesticide     exposure suitable to their specific conditions. The purpose of the present study is to     examine factors that influence farmers' use of personal protective equipment during their     work with organophosphates and, based on this examine the ability of locally adapted personal     protective equipment to reduce their organophosphate exposure. The hypothesis is that farmers     working in locally adapted personal protective equipment have less acute organophosphate     poisoning symptoms, a higher plasma cholinesterase level and find it to be a more feasible     solution than farmers working in their daily practice wearing. Examining how locally adapted     personal protective equipment (onwards referred to as the LAPPE solution) performs in     practice implies testing it in an intervention study. A randomized crossover experiment     design is chosen partly because fewer farmers have to be recruited since each farmer will act     as his own control and partly because the between farmer variation is strongly reduced. The     performance of the LAPPE solution will be tested in one experiment and compared to the     performance of the same farmers' daily practice wearing (onwards referred to as the DP     solution) in another experiment. The LAPPE solution is expected to have a superior     performance. The participation sequence (LAPPE/DP or DP/LAPPE) will be randomized. The study     will be conducted among farmers in Chitwan, Nepal.   "
87764|NCT02137304|"     The investigators want to demonstrate that there is an optimal expiratory pressure when using     mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is     between the need to generate a high pressure difference between alveoli and the mouth and the     need to avoide and superior airways collapsus.   "
87765|NCT02137291|"     Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used: the     double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by the     majority of anesthesiologists for both left and right thoracic surgeries. Standard     right-sided DLT (Rs-DLT) is rarely use since it is dif¬ficult to properly position it and     that there is a risk of misalignment between the lateral orifice of the tube and the origin     of the right upper lobe (RUL) bron¬chus. In 2007, the investigators have published results     suggesting enlarging the Rs-DLT's lateral orifice. The modified R-DLT (Rm-DLT) was more     frequently in an adequate position: 77% vs 37% of patients (p = 0.0121), and easier to     reposition: 97% vs 74% of patients (p= 0.0109) in comparison to the standard R-DLT group. The     data suggest the superiority of the Rm-DLT compared to Rs-DLT for optimal positioning to     facilitate one-lung ventilation (OLV) during thoracic surgery. It is believed that DLT tend     to provide quicker and better quality of lung collapse than BB. In 2013, investigators have     demonstrated an equivalent quality of lung collapse (LC) between L-DLT and BB used with two     apnea periods when initiating OLV. Complementary analysis showed a significative difference     to obtain complete LC (CLC) between L-DLT for left thoracoscopy and L-DLT for right     thoracoscopy and BB in right or left surgery. The investigator hypothesis is that, when using     L-DLT for left video-assisted thoracoscopic surgery (VATS), LC of the isolated lung will be     slower and of poorer quality compare to the use of the Rm-DLT. The primary objective is to     compare the delay between pleural opening (PO) and CLC in left VATS when using three lung     isolation devices: 1) L-DLT and 2) Rm-DLT. Secondary objectives are: 1) to evaluate quality     of LC, 2) to evaluate the level of obstruction of the lumen of the left bronchus, 3) to     evaluate the quality of OLV (PaO2) 4) To collect blind surgeon's opinion about de device used     and 5) to measure the delay between OLV and PO for evaluating the role of absorption     atelectasis in obtaining CLC. After obtaining IRB approval, the investigators propose a study     of 40 patients undergoing an elective left VATS at IUCPQ involving one lung ventilation. They     will have to be 21 years or more, to read, understand and sign an informed consent at their     pre-operative evaluation. This study will be prospective, randomized, and blind to thoracic     surgeons.   "
87766|NCT02137278|"     Investigate clinical effects (reduction of number of syncope and associate symptoms) of     suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.   "
87767|NCT02137265|"     Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could     improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.   "
87768|NCT02137252|"     Naltrexone is a drug which blocks some effects of chemicals called beta-endorphins that are     made in the body. Beta-endorphins can be made in response to stress, injury, and also     pleasurable activities. In previous studies, it has been shown that levels of beta-endorphins     in the blood go up during radiation therapy, and that this increase is linked to fatigue.     This suggests that naltrexone may help to reduce fatigue in people who are getting radiation     therapy In this research study, the investigators are looking to see whether naltrexone works     better than a placebo in reducing fatigue during radiation therapy.   "
87769|NCT02137239|"     Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress     the immune system (called immunosuppressive regimens) to stop the immune system from     attacking the transplanted kidney in order to limit damage to or the possibility of rejecting     the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two     immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate     mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.   "
87770|NCT02137226|"     Primary Objective:      The primary objective of this trial is to establish an equivalence in efficacy between BI     695501 and US-licensed Humira® in patients with active RA based on a statistical comparison     of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response     rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®.      Secondary Objectives:      The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity     of BI 695501 and US-lisensed Humira® in patients with active RA including those undergoing     the transition from US-licensed Humira® to BI 695501 after 24 weeks.   "
87946|NCT02134925|"     This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant     vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous     polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer     over time. Vaccines made from peptides may help the body build an effective immune response     to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence     of adenomatous polyps and may prevent the development of colorectal cancer.   "
87771|NCT02137213|"     At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from     constipation that often affects effectiveness of MMT and increases its impact on health care     system. Existing treatments include several over-the-counter medications which do not target     the pathobiological basis of opioid-induced constipation and have limited effectiveness. At     the same time well-known medication, naloxone, was already shown to help with constipation in     patients receiving methadone for chronic pain, but was never tried in patients receiving     methadone for opioid dependence. This study is aimed to try naloxone for treatment of     opioid-induced constipation in MMT settings.      The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced     constipation. The study has a crossover design - all patients will receive one week of their     regular methadone doses and one week of their regular methadone doses with naloxone added.     Normal saline will be added to methadone-only formulations as placebo. Order of the weeks     will be chosen randomly. Both subjects and investigators will be blinded to the study     condition (i.e. whether naloxone or normal saline is added to methadone preparation on a     given week).      Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1     will have less severe symptoms of constipation compared to those receiving methadone only.      Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause     clinically significant opioid withdrawal symptoms.   "
87772|NCT02137200|"     The investigators propose a large, multicenter, randomized clinical trial of immediate versus     delayed pushing for nulliparous women in labor at term reaching complete cervical dilation.     The central hypothesis is that immediate pushing in the second stage of labor increases     spontaneous vaginal delivery, shortens duration of the second stage, and reduces adverse     neonatal and maternal outcomes in nulliparous women. They will pursue the following specific     aims: 1) Assess the effectiveness of immediate pushing at complete cervical dilation on the     rate of spontaneous vaginal delivery in nulliparous women (Primary Aim), 2) Determine the     effect of immediate pushing on the rate of neonatal composite morbidity (Secondary Aim #1),     and 3) Determine the impact of immediate versus delayed pushing on objective and subjective     measures of maternal pelvic floor morbidity (Secondary Aim #2). They estimate that     randomizing a total of 3184 women will provide adequate statistical power to detect     meaningful differences in the primary and secondary outcomes.   "
87773|NCT02137187|"     There is evidence of superiority of AV junction ablation strategy over pharmacological     therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization,     morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to     pharmacological therapy as regard hospitalization and mortality   "
87774|NCT02137174|"     Home and school visits by multidisciplinary team will improve metabolic control in kids     having insulin dependent diabetes mellitus   "
87775|NCT02137161|"     OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing     postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract     surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin     0.3% ophthalmic solution).      DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical     trial.      PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned,     according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n =     31).      INTERVENTION Cataract surgery by means of phacoemulsification and implantation of     posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.      Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given     starting the day after the surgery for two weeks, dosed QID for the first week and BID for     the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).      Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after     surgery. Standard post-operative topical antibiotic and steroid will be also given     concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1%     and tobramycin 0.3% eye drops association).      Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks     from cataract extraction.   "
87776|NCT02137148|"     The goals of this study are as follows; evaluation of the products' readiness to market,     ascertain initial reactions by target users, evaluate actual use in potential clinical     settings and any difficulties encountered with product use and actual venous cannulation.   "
87777|NCT02137135|"     Fluctuations of female sex hormones during the menstrual cycle influence pain perception.     Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The     investigators tested the primary hypothesis that the women having surgery during their     follicular phase have more acute pain and require more opioids than those in the luteal     phase, and secondarily the investigators tested that women who have surgery during their     follicular phase have more incisional pain at 3 month postoperatively.   "
87778|NCT02137122|"     This study will investigate whether transcranial direct current stimulation enhances the     effects of cognitive training in healthy older adults.   "
87779|NCT02137109|"     The primary objective of the study is to evaluate the safety of natalizumab use in the     pediatric multiple sclerosis (MS) population.   "
87780|NCT02137096|"     This is a pilot study to evaluate the response rates for patients undergoing high dose     conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous     stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in     children, adolescents, and young adults.   "
87781|NCT02137083|"     Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer   "
87782|NCT02137070|"     This study is being done to learn about the changes that weight loss causes on brain     function, memory and thinking ability in adults. The study does NOT cover any costs     associated with bariatric surgery.   "
87846|NCT02136238|"     This study will compare the functional performance of voluntary opening (VO) and voluntary     closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension     and produce progressively higher pinch from shoulder force will result in advantages for the     VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The     specific aims of this clinical trial are to:        1. Determine if accommodation with a VC Grip 3 prehensor will result in reduced          compensatory motion during activity.        2. Determine if accommodation with a VC Grip 3 prehensor will result in improved function          in activities of daily living.   "
87785|NCT02137031|"     The primary purpose of this pilot randomized controlled trial is to provide preliminary     indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose     monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and     (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of     recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine     participants' satisfaction with allocated treatment.      With increased and immediate information related to current and future (trend) glucose     information provided by the continuous glucose monitor, children can then act upon this     knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose     variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c     levels.      Research on the effectiveness of continuous glucose monitoring on metabolic control in     children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore,     a pilot clinical trial will be designed to provide preliminary indicators of the feasibility     and acceptability of continuous glucose monitoring on metabolic control and address the     following objectives.   "
87786|NCT02137018|"     Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new     fixing method for prosthetic materials in the treatment of abdominal wall hernias,     diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster     in laparotomy procedure and laparoscopic procedures. Experimentation on breed pig Lantrace     ANIMAL MODEL.   "
87787|NCT02137005|"     The purpose of this study is to investigate longitudinally, the walking ability of     individuals with cerebral palsy who are transitioning into adulthood and to cross-sectionally     examine the health status of these individuals in the context of their walking ability. Young     adults who received instrumented gait analysis (IGA) as children will show significant     decreases in overall gait performance, as measured by kinematics, kinetics, temporal-spatial     parameters, and gait deviation index, compared to their last childhood IGA.   "
87788|NCT02136992|"     Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti-     fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and     safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of     pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a     large sample of clinical cases.   "
87789|NCT02136979|"     CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune     related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during     cardiac surgery, and induce immunosuppression. In recent previous studies, CD39 and CD73 was     known to have important role in cancer patients for inducing immunosuppressive reaction and     consequently induce cancer cell proliferation. However, the immunosuppressive effect of CD39     and CD73 during CPB time was not evaluated in previous studies.      The authors hypothesized that CD39 and CD73 would have important role in CPB induced     immunosuppression. Therefore, the present study determined the effect of CD39 and CD73 during     CPB.   "
87790|NCT02136966|"     Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact     evaluation Hypothesis: The fortification of complementary foods associated with a counseling     on feeding practices for infants and young children prevents malnutrition in 6-23 months-old     children.      Objective: to assess the effectiveness of a promotional care package in preventing     malnutrition among children aged 6-23 months.   "
87791|NCT02136953|"     Obsessive compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting     2% of the population. Cognitive behavioural therapy (CBT) is considered first line     psychological treatment for OCD, but there are a large number of treatment non-responders,     and the majority of responders have residual symptoms. Aerobic exercise has shown potential     benefit for general mood and anxiety disorders, but has not been widely tested in OCD. This     study will examine the additive benefits of a standard 12-week aerobic exercise program to a     standard 12-week CBT protocol in the treatment of OCD. The study will test if Exercise+CBT     results in significantly better clinical outcomes compared to either treatment alone or no     treatment at all. Treatment outcomes will be assessed in relation to symptom and cognitive     measures of clinical improvement.   "
87792|NCT02136940|"     The objective of this parallel group study is to evaluate the safety, tolerability and     efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle     glaucoma or ocular hypertension.   "
87793|NCT02136927|"     Pharmacokinetic, bioequivalence study   "
87794|NCT02136914|"     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group     study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an     investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of     levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel     pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the     early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in     the evening, potentially reducing the negative impact of amantadine on sleep. This     pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER     formulation than can be tolerated with an immediate-release formulation. The once-nightly     dosing regimen may also provide enhanced convenience and compliance.      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly     reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.   "
87795|NCT02136901|"     The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized,     interventional clinical trial to test the hypothesis that the NUsurface implant is superior     to the non-surgical standard of care in treating the target population.The rationale for     performing this clinical study is to gather clinical data to evaluate the safety and     effectiveness of the NUsurface device compared to the Standard of Care.   "
87796|NCT02136888|"     The aim of this study is to demonstrate that therapeutic and supratherapeutic plasma     exposures to ponesimod do not have an effect on cardiac repolarization exceeding the     threshold of regulatory concern as measured by the QTc (interval from beginning of the Q wave     until end of the T wave corrected for heart rate) interval duration after administration of     multiple oral doses of 40 mg and 100 mg to healthy male and female subjects.   "
88062|NCT02133404|"     To examine efficacy and safety after 12-week administration of ASP7991 in secondary     hyperparathyroidism patients undergoing hemodialysis   "
87798|NCT02136862|"     There is limited published clinical data about the natural history of renal disease in Alport     syndrome. The RG012-01 study will collect data to characterize the progression of renal     dysfunction in Alport syndrome patients.      Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be     considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow     an assessment of the rate of change of established clinical endpoints, such as GFR and/or the     rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects     whose renal function is steadily declining. The identification of surrogate markers that     track the decline of renal function and could correlate with time to end-stage renal disease     (ESRD) is a key goal of the natural history study.   "
87799|NCT02136849|"     Intellectual disability (ID) moderate or severe affects about one child in 250, with 3000 to     4000 new cases each year. Chromosomal or molecular pathology causes are not identified in     half of the cases by current techniques. Studies show that de novo mutations are common in     many different genes. The exome approach by high-throughput sequencing (NGS) has emerged as     the technique of choice for identifying and comparing the exome of the child to the parent.     We wish to evaluate this approach and its contribution in the diagnostic management of 50     patients with DI seen in genetics in 6 CHU Great West. Genomics platform IBISA / Biogenouest     will provide technological and bioinformatics support this project.   "
87800|NCT02136836|"     The objective of this study is to investigate the proportion of HER2 overexpression in     gastric cancer patients group, to evaluate the relation of HER2 overexpression with     prognosis, and to analyze the proportion of herceptin applied to patients in clinical field.     Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for     survival prolongation compared to chemotherapy only.   "
87801|NCT02136823|"     This study is being done to measure the differences between the electrical activity of     muscles and /single muscle fibers in individuals with long-term spinal cord injury and     neurologically intact individuals without spinal cord injury. This study is also being done     to find out if muscle and /single muscle fiber electrical activity, voluntary strength,     reflex measurements, and/or spasms are changed after a single, oral dose of three commonly     prescribed drugs, Rilutek®, isradipine, and Namenda®. These medications are approved by the     FDA for treatment of disorders other than the control of spasms and strength. In this study,     they are being used in an experimental manner. Finally, this study is also being done to find     out whether or not a brief stretching exercise influences reflex measurements.      The main hypothesis of this study is that aberrant current activity in spinal motoneurons     contributes to spastic hyper-reflexia following chronic spinal cord injury.   "
87802|NCT02136810|"     This study aims to assess the performance of presurgical clinic blood pressure measurements     in predicting home blood pressure readings among surgical patients. It also aims to measure     the association between home blood pressures and patient perspectives on blood pressure     control.   "
87803|NCT02136797|"     The purpose of this study is to see how well transfusions of T-cells work in treating CMV.     Tcells are a type of white blood cell that helps protect the body from infection. A     transfusion is the process by which blood from one person is transferred to the blood of     another. In this case, the T-cells are made from the blood of donors who are immune to CMV.     The T-cells are then grown and taught to attack the CMV virus in a lab.   "
87804|NCT02136784|"     The aim of this study is to examine the effects of opioid analgesics on acute pain in     participants maintained on buprenorphine+naloxone (Suboxone) for opioid use disorders. Seven     medication conditions will be tested in a cold pressor test (CPT) paradigm.   "
87805|NCT02136771|"     In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D     deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3     supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory     blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether     vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity,     N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett     formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model     Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.   "
87806|NCT02136758|"     This study was a prospective, randomized trial designed to investigate the efficacy of     moderate lifestyle modification for improving the clinical status of patients with coronary     artery disease or patients with risk factors that promote coronary artery disease.   "
87807|NCT02136745|"     In this pilot study, the investigators examined whether a relaxation response mind-body     intervention could be effectively delivered to mixed groups of IBS and IBD patients and     determined the effects of the intervention on quality of life, inflammatory markers, and gene     expression using transcriptional profiling.   "
87852|NCT02136160|"     Population based intervention at elementary school setting aimed at contributing, to a major     extent, to health education and health promotion for children aged approximately 5-10 years     in Germany. Health education units with theoretical and practical exercises for use by     teachers, children, and parents addresses physical activity, sedentary behavior, relaxation,     nutrition, personal hygiene and body awareness.      Main questions of the pilot are:      Does health promotion take on an important role in primary schools? How do teachers evaluate     training materials, homepage, content and framework conditions? How do teachers assess the     efficiency of teaching units?   "
87844|NCT02136264|"     An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats,     and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food     intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com).     Hence a personalized categorical food avoidance diet averts relapse and maintains remission     of psoriasis, with side benefit on blood pressure and other metabolic parameters (J     Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis: this dietary approach would     improve the control of essential hypertension. A randomized controlled clinical trial is     proposed to compare this dietary approach with conventional DASH-type dietary counselling. 40     study participants will be randomly assigned to either conventional or interventional dietary     counselling. They will be comprehensively monitored (including gene expression studies) for     two years. Outcome criteria will include blood pressure, complications of hypertension,     side-benefit on comorbidity, and requirement for antihypertensive drugs.   "
87808|NCT02136732|"     With a growing aging population, the number of persons with chronic conditions continues to     escalate and challenges related to chronic care quality, effectiveness and cost remain     unresolved.Federally Qualified Health Centers (FQHC) have experienced increasing numbers of     patient visits for chronic conditions, and FQHC patients are more likely to have serious     chronic conditions when compared to patients being cared for by non-FQHC providers.      The Chronic Care Intervention (CCI) combines home visiting with health activation coaching     and has resulted in improved health status and reduced expenditures (Preliminary Studies).     Implementing the CCI for aging adults with multimorbidity (2 or more chronic conditions) and     high baseline acute care utilization, allows us to test and expand the efficacy, external     validity and cost effectiveness of the proposed intervention model. The investigators seek to     improve patients' and FQHCs' abilities to effectively manage chronic conditions and reduce     acute care use. This contribution is significant because it potentially extends our knowledge     about effective community partnerships and best practices that can enhance the effectiveness     of health homes in providing patient-centered team-based care for patients with     multimorbidity and high baseline health care utilization.   "
87809|NCT02136719|"     the investigators aim to compare bimanual uterine compression immediately after delivery of     the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage     in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is     postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of     additional uterotonics and need for blood transfusion.   "
87810|NCT02136706|"     Encouraged by the recent data published ,the investigators think that a waiting time of 10     minutes is feasible while preserving diagnostic accuracy and would like to assess the     feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By     combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial     perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for     W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute waiting).      The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the     patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides     diagnostic accuracy comparable to W30 MPI.   "
87811|NCT02136693|"     This study aims to assess whether fiber intake, formerly recommended only before or instead     of surgery, may play a role in improving postoperative progress and functional outcome after     STARR for obstructed defecation, in terms of residual constipation, incontinence and     defecation urgency.   "
87812|NCT02136680|"     This is an investigator-initiated study to measure the impact of an educational intervention     of the basic palliative approach for a multidisciplinary staff team of an outpatient HIV     clinic early in disease trajectory. The study aims to 1) refine a curriculum for     non-palliative clinicians caring for persons living with HIV disease early in disease     trajectory; 2) assess the impact of this palliative educational intervention on outcomes for     2 target populations: a) staff (burn-out and caregiving stress) and b) patients (retention in     care, mental health, and quality of life). It is hypothesized that training outpatient HIV     staff in palliative competencies will improve care provided that might, in turn, improve     clinical outcomes for one group of HIV patients receiving care from the clinic. Quantitative     data will be augmented by qualitative interviews of selected staff and patients in the final     year of the study to appreciate response to the intervention.   "
87813|NCT02136667|"     In order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year     follow-up study comparing 32 exposed (women with a history of pregnancy complicated by     preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy).      Participants will be recruited from a well-characterised cohort, previously assembled during     their pregnancies, at the Department of Obstetrics at Randers Regional Hospital in 2001-2004.      Blood and urine samples, collected during their pregnancies, are stored in a biobank, thus     rendering the possibility of longitudinal assessment.   "
87814|NCT02136654|"     South Asians (SA) living in Canada and globally have high rates of type 2 diabetes     (diabetes). Despite the burden of diabetes in this population, diabetes management remains     poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in     exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid     targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent     to their diabetes life-saving medications, compared to 30-35% non-adherence in the general     population (7). This large gap in diabetes care is not surprising given language and     communication barriers between primary care providers and SA patients (8-10), lack of     knowledge about diabetes (8-11), preference for alternative therapies (12-14) and     fundamentally different cultural beliefs on diabetes and diabetes management (15-18).     Although there is some preliminary evidence that culturally tailored, chronic disease models     may improve outcomes (21-24), the current evidence base is insufficient to justify the system     modifications required to provide culturally tailored care across primary care settings in     Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel     culturally tailored lifestyle and medication adherence intervention in SA patients with     poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes     Treatment (NaMaSTe-Diabetes) trial in primary care.   "
87815|NCT02136641|"     Objective: To determine the efficacy of sedation schemes to sedation in patients about to     undergo spinal anesthesia.      Methods: Pilot study, clinical type, randomized, prospective, single-blind, in which the     investigators compared three schemes for sedation in patients undergoing spinal anesthesia.      Keywords: Anesthesia, Spinal Anesthesia, Conscious Sedation, Operating Rooms.   "
87887|NCT02135705|"     This global product exposure registry is a multicentre, long-term, prospective, observational     cohort study (exposure registry), designed to evaluate the long term safety and effectiveness     of lomitapide.   "
87958|NCT02134769|"     Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon.     However, there are no studies describing a positive effect of using Bionecteurs ® in regard     to catheter-related bloodstream infections. In this study Bionecteur® will be used on central     venous lines and arterial lines in postoperative patients of a 40-bed ICU. The incidence of     catheter-related bloodstream infections will we compared to patients without inclusion of     Bionecteur® devices.   "
87816|NCT02136628|"     The posincisional hernia is considered a delicate complication , with an incidence of 10-12%     in patients undergoing laparotomy may reach 45% in case of emergency and high-risk patients .     It is estimated that in the United States are made about a million of reoperations for     correction of this complication , with millions and despite the myriad studies that have been     done in recent years there has been a decrease in the incidence losses and mortality of this     complication.      Given the seriousness of this problem the last global consensus guidelines sent to the     surgical community in three main areas: Identify the importance of the problem, improve the     theoretical knowledge and technical capacity in the closure of the abdominal wall and     Implement prophylaxis in selected patients.      The technique of reinforced tension line (RTL) was proposed by hollinsky and collaborators     and is a strengthening of the abdominal incision with placement of a suture that runs lateral     to the edge of the incision and closure of the abdominal wall is performed the usual manner     with the only surgete continuous suture for closure is placed lateral to the suture     reinforcement.      In the present study may contribute to these guidelines and to groups of patients at high     risk were identified and applying the RTL technique and demonstrate that its use is safe and     useful in reducing the presence of this complication could be implemented as prophylaxis     handling the same .      The RTL method was applied experimentally on bodies to close the abdominal wall also be used     in a cohort of patients for hernia repair wall , showing that by using it the abdominal wall     is more resistant to shear forces by theoretical foundation that exists to show that could     prevent the development of incisional hernias. There are no studies in the literature     comparing this technique against conventional methods of closure of the abdominal wall as to     the prevention of the same.   "
87817|NCT02136615|"     In a recent series of studies performed by our group, we have shown that exposure to     hyperbaric oxygen (HBOT) leads to an increase in insulin sensitivity in male subjects and     that this improvement can be measured in all men, not just those with diabetes. The aim of     this study is to investigate the time course of this effect and explore the mechanisms     involved when exposure to HBOT induces an increase in peripheral insulin sensitivity.      Aims:        1. To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after          an HBO session.        2. To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.   "
87818|NCT02136602|"     Good glycemic control is superior to poor glycemic control in reducing risk of     interventricular septal thickness among fetuses of diabetic mothers.   "
87819|NCT02136589|"     PG-analogues induce hyperemia as one of side effects in addition to IOP reduction.      IOP reduction is caused by direct FP receptor stimulation, but the cause of hyperemia is not     clarified.      Because FP receptor stimulation induce intrinsic production of PGs, hyperemia or IOP     reduction may be due to secondary induced PGs.      Thus, pretreatment with NSAID may affect the PG-analogue induced hyperemia or IOP reduction.   "
87820|NCT02136576|"     The aim of this pilot research project is to compare the clinical effect on dentinal     hypersensitivity of three products: Casein Phosphopeptide-Amorphous Calcium Phosphate     (CPP-ACP) paste with fluoride, 5000 Sodium Fluoride (NaF) dentifrice containing Tri-Calcium     Phosphate (TCP), and a dentifrice containing Potassium Nitrate.      The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will     exhibit a greater reduction in dentinal hypersensitivity compared to the control (dentifrice     containing Potassium Nitrate).      The results of this pilot study will validate or negate the need for a larger clinical study     that may provide generalizable results for using caries-prevention products with the     additional benefit of minimizing dentinal hypersensitivity.   "
87821|NCT02136563|"     This is an observational clinical research on patients with chronic kidney disease who are     not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major     objective is to explore novel erythropoiesis stimulating agent (ESA) response index in     association with deterioration of renal function as well as occurrence of cardiovascular     disease events.   "
87822|NCT02136550|"     Smoking cessation improves health conditions with reduction of the risk factors for     cardiovascular and respiratory disease, as functional capacity and quality of life. Smoking     cessation has positive effects on the miRNAs regulation, however, genomics has been little     explored. Smoking and aging induces changes miRNAs. Among the changes in airway epithelial     cells, miR-125 called attention because it is enrolled in the suppression of ERBB7 (tirosin     kinase receptors), a codified sequence of the growth factor receptor (EGFR) frequently     expressed in cancer. The reduction of miR-125 expression may reduce cancer suppression     resulting in cancer development. Other miRNA changes can be observed, such as miR-218 that     were found in smokers airway epithelial cells as in MiR-15b that were found in lung tissue of     COPD smokers. These miRNAs participated in the signalling pathway of TGF-β enrolled in     leukocyte migration and cell proliferation. The investigators hypothesize that smoking     cessation has a role in the regulation or reduction in the genetic changes smoking-induced.     The investigators will assess the subject genomic profile at the baseline, 6 months and 12     months after smoking cessation.   "
87823|NCT02136537|"     The investigators wish to investigate the effects of neuromuscular stimulation on     intermittent claudication.   "
87824|NCT02136524|"     This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence     crossover study to determine the relative bioavailability of cobimetinib administered as a     single dose of the tablet formulation relative to a single dose of the capsule formulation to     healthy male and female participants. A minimum of 24 participants (12 participants per     sequence) will complete the study. Participants will be randomly assigned to 2 possible     sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One     cobimetinib tablet administered as a single oral dose after at least an 8-hour fast;     Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an     8-hour fast. The study is expected to last approximately 7 weeks.   "
87825|NCT02136511|"     This study is to provide idelalisib (IDELA) to individuals with relapsed, previously treated     chronic lymphocytic leukemia (CLL) who have limited treatment options and are not eligible     for other Gilead-sponsored studies.   "
87826|NCT02136498|"     The purpose of this pilot study is to evaluate the acceptability and feasibility of the     proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).   "
87899|NCT02135549|"     To assess the safety and effectiveness of two doses of SugarDown in two different doses vs.     placebo on serum glucose levels after meals in subjects with Type 2 Diabetes treated with     metformin alone. There will be five visits, a screening visit, baseline visit, and 3     treatment visits. The study duration will be five weeks. Subjects will all receive placebo     tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will     be measured in frequent intervals over four hours immediately following the meal. Subjects     will be randomized to one of the six treatment sequences. Patients will take in an unknown     order one week of placebo, one week of 4 g dose and one week of 8 g dose of SugarDown     immediately before breakfast, lunch and dinner meals. Patients will continue their usual     metformin regimen during the trial period.   "
87827|NCT02136485|"     This application concerns a proposed randomised controlled trial evaluating the use of     Mindfulness-based stress reduction (MBSR) in people with Multiple Sclerosis (MS) in secondary     care.      MS is an inherently stressful condition, and stress is thought to exacerbate MS. Mental     health problems are common in MS, can impair quality of life, and lead to higher rates of     suicide.      Prior research has shown that cognitive behavioural therapy (CBT) can help mitigate stress     and diminish disease activity in MS, but effects are short-lived and there is thus a need to     explore whether other psychological approaches might be more beneficial in this regard.      MBSR is another psychological stress reduction technique that is thought to operate     differently to CBT, via cultivating a state of meta-cognitive awareness and has shown to be     helpful when used in other long term conditions, such as chronic pain and anxiety, whilst     Mindfulness-based cognitive therapy (MBCT - a derivative of MBSR) is effective in treating     recurrent depression. All of these conditions are common in MS. However, mindfulness based     interventions have not been well studied in MS.      The investigators propose to carry out a feasibility study to assess how acceptable and     accessible MBSR is as a stress reduction technique in people with MS. The investigators would     seek up to 50 participants who would then be randomly assigned to receive MBSR or their usual     care. The investigators would seek measurements of health and wellbeing before, immediately     following, and 3 months following the MBSR intervention. This would include basic demographic     information (age, gender, ethnicity), measures of mental health, and physical health, as well     as qualitative semi-structured interviews with selected participants. After this we would     offer MBSR to the control group.   "
87828|NCT02136472|"     Introduction:      Overall, 10 - 15% of couples seek specialist help once in their lives when a spontaneous     pregnancy does not occur. These couples are defined subfertile when there is at least one     year of unprotected intercourse without conceiving. Subfertility can have different causes     which can be diagnosed with a basic fertility work-up. Unfortunately, the subfertility in 25%     of the couples still remains unexplained.      Hypothesis:      The investigators hypothesize that cardio-metabolic and hemodynamic abnormalities reducing     cardiovascular reserves relate to circulatory redistribution at the expense of uterine     perfusion and with it women's fertility. This could especially be important in the subgroups     with an unexplained subfertility and a decreased ovarian reserve. Interventions to improve     these abnormalities could lead to better results in fertility treatment, better obstetric     outcome and reduced lifelong health risks.      Objective:      The investigators want to examine specific cardio-metabolic and cardiovascular parameters in     women of subfertile couples. The investigators want to evaluate the prevalence of metabolic     syndrome in all women who are assessed for subfertility compared to healthy parous women.     Furthermore in the women with an unexplained subfertility or with (signs of) a decreased     ovarian reserve the cardiovascular profile will be studied consisting of the uterine artery     pulsatility index (PI) as measure of uterine perfusion, the plasma volume as measure of     venous reserve capacity, the intima media thickness of the carotid arteries as proxy of     chronic strain and the endothelial function, measured by flow mediated dilatation (FMD) of     the brachial artery.      Study design:      Cross-sectional      Study population:      The study group consists of subfertile women between 18 and 41 years who visit the fertility     clinic in the Maastricht University Medical Centre with a primary or secondary subfertility.     Women with an unexplained subfertility or with (signs of) a decreased ovarian reserve are     evaluated for their cardiovascular profile. The control group consists of women with a     history of an uneventful spontaneous pregnancy.      Main study parameters:        1. Prevalence of metabolic syndrome in subfertile women        2. The cardiovascular profile, in women with an unexplained subfertility or with (signs of)          a decreased ovarian reserve, consisting of:             -  The uterine artery pulsatility index             -  The plasma volume             -  The intima media thickness (IMT)             -  The endothelial function of the vascular system (FMD)   "
87829|NCT02136459|"     The purpose of this study is to test the investigators hypothesis that intubation with a     smaller ETT would lead to reduced postoperative vocal impairment and laryngoscopic evidence     of laryngeal trauma than intubation with a standard size ETT.   "
87830|NCT02136446|"     Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to     one of 2 groups.      Group 1 will have the nerve block performed using a standard non-echogenic needle and     catheter under ultrasound guidance. Group 2 will have the block performed using the control     needle and an echogenic catheter, all under ultrasound (US) guidance.      The clinician will be blinded to the catheter type and will assess the quality of catheter     visualisation of the US image during the procedure, along with adequacy of spread of local     anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be     block success rate and block quality. An assessment of the patient's pain levels after the     procedure will also be conducted.   "
87831|NCT02136433|"     The purpose of the study is to test the effectiveness of training using novel tablet     applications for hand function, compared to traditional hand exercises. In addition, we aim     to examine brain plasticity following treatment with the new tablet applications. We     hypothesize that training with a tablet would prove to be more effective than traditional     exercises. We expect to observe neuroplastic changes in the brain in patients who practiced     finger movements using the tablet.   "
87832|NCT02136420|"     The investigators will study adaptation of motion perception and manual control in altered     gravity, including the effects of a drug (promethazine). The investigators will also study     whether promethazine affects motion perceptual thresholds.   "
87833|NCT02136407|"     The purpose of this study was to study seasonal inter-individual and intra-individual     variations in S-25(OH)D and to explore parameters associated with S-25-OHD in healthy Swedish     adults.   "
87834|NCT02136394|"     Scarring of the lungs is common in patients with scleroderma and is one of the main causes of     death. Patients with scleroderma very frequently have problems with their gullet (esophagus),     the food pipe that leads into the stomach.      Normally, a small circular muscle at the base of the esophagus opens to allow food to pass     into the stomach and closes to keep the digestive fluids from flowing back up into the     gullet. In patients with scleroderma, the muscle may become weak and no longer close     properly. Gastroesophageal reflux (GER) is the medical term for reflux of stomach contents     into the esophagus.      Our hypothesis is that small amounts of GER can move back up into the esophagus and get     inhaled into the lungs, and may be one of the triggers for lung scarring. We propose to look     for certain substances normally only found in the stomach in the exhaled breath condensate     which is collected by breathing comfortably into a cooled cylinder, allowing the breath to     condensate. In a smaller group of patients, we also plan to perform a bronchoalveolar lavage,     a more widely studied test in which a small amount of fluid is introduced into a small part     of the lungs through a fine tube, and then removed for examination, to evaluate whether the     two tests provide similar measurements. We will also evaluate the correlation between these     molecules and other tests, including lung function, and markers of lung scarring activity,     and tests to look at how the esophagus is working so that we can get a clearer picture of how     this affects patients' daily lives. Finally, we will be following up patients over time with     lung function to see whether evidence of GER into the lungs is linked with a greater     likelihood of worsening of lung scarring in the future.   "
87900|NCT02135536|"     The purpose of this study is to determine the safety, tolerability, and activity of extended     treatment with NGM282 in patients with Primary Biliary Cirrhosis.   "
87835|NCT02136381|"     The LiveWell research programme aims to develop evidence-based, acceptable and scalable     interventions to improve health and wellbeing in the retirement transition.      Life stage transitions involve changes in lifestyle and thus present key opportunities for     behaviour change interventions. Our assessment of the literature shows that interventions     with people of retirement age can effectively promote components of the Mediterranean diet     (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine     Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87:     2013).      This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking     place in the North-East of England.      We have developed an internet-based lifestyle programme (Living, Eating, Activity and     Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1)     healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use     of a step-counter, and 3) improving social connectedness.      Participants recruited for this study will be allocated in random order with a ratio of 2:1     to the intervention group (LEAP) or to a control group.      This study will evaluate the feasibility and acceptability of the LEAP intervention among     people of retirement age and will pilot trial procedures.      In this programme of research we have also defined a suite of outcome measures and identified     tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas.     2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability,     Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of     these measures has yet to be determined and therefore will be formally assessed in this pilot     RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical     activity and social roles).      The hypotheses to be tested in the LiveWell programme are as follows:        -  A newly developed internet-based lifestyle programme (Living, Eating, Activity and          Planning through retirement (LEAP)) is an acceptable tool for behaviour change among          people of peri-retirement age.        -  A suite of outcome measures and identified tools appropriate for capturing the Healthy          Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.   "
87836|NCT02136368|"     The purpose of this study is to investigate whether an exercise class with a cognitive (or     brain) training component was more effective than a usual combined aerobic and resistance     exercise class for older adults with cognitive complaints (such as concerns about changes in     memory or thinking skills). It is hypothesized that the group randomized to the exercise     class that includes additional brain training will have greater improvements in brain health.   "
87837|NCT02136355|"     Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers     high-dose, precise radiation to small tumors in 1-3 weeks of treatment.      The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done     first, with surgery done approximately 10 weeks later. There will be some extra imaging done     before and after the SABR.      The purpose of this study is to determine how effective SABR is in killing the cancer cells,     and if SABR can help make surgery more effective.   "
87838|NCT02136342|"     The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.   "
87839|NCT02136329|"     The objectives of the study are the following:        -  To evaluate the pharmacokinetic profile of Sildenafil in cardiac surgery patients at          risk of acute kidney injury        -  To determine the safety and tolerability of Sildenafil in cardiac surgery patients at          risk of acute kidney injury   "
87840|NCT02136316|"     The purpose of this study is to evaluate the safety and tolerability as well as the     pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and     female subjects.   "
87841|NCT02136303|"     The age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In     Western industrial countries, it is the main cause of visual impairments. In Germany,     approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are     mainly important in AMD development. Until now, AMD-patients are advised to use supplements     based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated form.     Results showing the effects of food items (kale, spinach) rich in lutein on improvement of     vision are scarce. And how much is needed within the diet? Within the planned project, human     intervention studies will investigate whether an oil-based kale extract or fresh kale can be     used to improve vision of AMD-patients and persons aged 50+ (without AMD). The first study     will use volunteers without AMD (>18 y) to investigate if there is a dose-dependent effect of     lutein and zeaxanthin (out of a kale extract) on macular pigment optical density (MPOD). This     study will also compare the bioavailability of the carotenoids from the extract and from a     supplement. A second study (also using volunteers without AMD, >18 y) will compare the     bioavailability of lutein and zeaxanthin from the extract and from kale purée. The third     study will investigate the effect of the oil-based kale extract on improvements of MPOD and     vision of AMD-patients and of a control group (volunteers 50+ without AMD).      Usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing     changes in concentrations in blood plasma. A fast, non-invasive sampling will be evaluated to     check the efficacy of an increased uptake of lutein. Thus, the project will test the     usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids.     Besides, the determination of carotenoid contents in skin will be checked on its use as     biomarker of carotenoids in plasma and macula.      Thus, the planned research project will evaluate two non-invasive markers of exposition on     their usability as markers of absorption of lutein and zeaxanthin in blood and macula. In     addition, the minimally needed dosage of lutein and zeaxanthin for AMD prevention will be     determined to reduce the possible risk of currently recommended doses of these compounds. The     project will also present alternatives (kale extract, kale purée) for AMD prevention and to     improve vision to be used instead of currently used high-dose supplements.   "
87842|NCT02136290|"     The primary goal of this clinical trial is to examine whether provision of portion-controlled     prepackaged foods in the context of a reduced-energy diet prescription and counseling is     associated with a greater degree of weight loss at three months in overweight or obese men     and women, compared to usual care or control conditions in which the prescribed     reduced-energy diet is to be consumed via self-selected foods. The effect on body weight and     recognized indicators of disease risk, diet quality and cardiopulmonary fitness, as well as     meal satiety and satisfaction, will also be examined. Participants are 184 overweight or     obese men and women in San Diego area who will be randomly assigned to usual care or control     conditions.   "
87843|NCT02136277|"     The purpose of this study is to investigate whether increases in the blood flow from the     heart (the cardiac output), induced by the administration of intravenous fluids, lead to an     increase in the blood flow to the vital organs, in patients undergoing bowel surgery.      This study will involve 2 phases. Firstly, potential volunteers will be invited to meet the     research fellow (medical doctor) undertaking this study, who will check their suitability to     participate in the study and who will obtain informed consent.      The second phase is the study itself which will take place whilst volunteers are having their     bowel operation. They will attend theatre in the normal way, but once they have been     anaesthetised (put to sleep), a special monitor called an oesophageal doppler probe will be     placed into their oesophagus (food pipe) via the nose. This monitor is frequently used in     bowel surgery to help assess how much intravenous fluid to administer to a patient by     measuring the cardiac output (the amount of blood pumped out of the heart each minute). Using     the cannula (drip) already inserted in the arm to allow administration of the anaesthetic, a     special fluid, called an ultrasound contrast agent, will be injected into the drip, to allow     a contrast enhanced ultrasound scan of the abdominal organs to be performed, to measure the     blood flow to these organs. A small sample of blood will be taken from the earlobe to allow     us to measure a chemical in the blood called lactate.      After this, intravenous fluid will be administered in order to increase the amount of blood     pumped out of the heart. Once the oesophageal doppler monitor suggests that an adequate     amount of fluid has been given, a second ultrasound scan will be performed to measure whether     blood flow to the abdominal organs has also increased. A further blood sample will be taken     from your earlobe to measure any change in lactate level.      At the completion of the operation, a third ultrasound scan will be performed and another     sample of blood taken from the earlobe, to help assess blood flow to the organs.   "
87935|NCT02135068|"     This study is designed to look at how snacking during exercise may help prevent low blood     sugars while subjects are on the closed loop artificial pancreas. This system uses a     continuous glucose sensor, an insulin pump, and a computer program that automatically     determines how much insulin to give based on the sensor glucose level.   "
87959|NCT02134756|"     Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day     intervention on aerobic exercise performance and fatigue.      The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and     reduce subjective measures of fatigue.   "
87847|NCT02136225|"     The purpose of this project is to examine the implementation and effectiveness of an     intervention, delivered in a health care setting, to decrease home firearm access by youth.     The investigators hypothesize that:        1. parents who receive means restriction education provided by their primary care provider          will be more likely to report, at the one month and one year follow-up, that they are          storing their guns locked compared to parents who do not receive means restriction          counseling.        2. parents who receive a free gun locking device(s) will be more likely to report, at the          one month and one year follow-up, that they are storing their guns locked compared to          parents who receive means restriction counseling alone;        3. parents whose adolescents are assessed at high risk for violence (> 5 on the Violence          Injury Protection and Risk Screen (VIPRS)) or depression (>9 on the Patient Health          Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at          the one month follow-up compared to parents whose children are assessed as low risk,          regardless of whether they receive the counseling alone or counseling plus free locking          devices and 4) youth whose parents receive a free gun locking device(s) will be more          likely to report less access to guns, at one year follow-up, compared to parents who          receive means restriction counseling alone.   "
87849|NCT02136199|"     The active strategy for dissemination and implementation of Share Evidence Based Medicine     (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a     greater uptake of use amongst encounters will be seen.      The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with     expertise in large-scale practice improvement at the state and national level. Largely funded     by health organizations in Minnesota, ICSI has a sustainable model to translate evidence into     practice, through clinical practice guidelines, shared decision making, and practice     redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may lead to a     sustainable and innovative approach to the dissemination of evidence-based health information     at the point of care.      The objective of the current study is therefore to leverage the expertise of these two     organizations to compare the impact of an active to a passive dissemination and     implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate     evidence-based information through the use of decision aids during encounters. The overall     purpose of the qualitative evaluation is to understand why decision aids were used more or     less in certain practices and what factors contributed to or hindered this uptake.   "
87850|NCT02136186|"     This study will evaluate the efficacy of home telemonitoring as an intervention to decrease     hospital readmissions in patients at high risk for readmission. The overall readmission rate     for high-risk MCF hospital patients is approximately 20%. Currently a system is in place to     identify and score all MCF patients for their risk of readmission. This score is based on     multiple variables including but not limited to: co-morbid conditions, patient's health     literacy, whether they are a Medicare/Medicaid patient, their in-home social support, and     whether they have had prior hospital admissions within the previous year. The literature     shows that home telemonitoring of patients has had mixed results for effectiveness at     preventing hospitalizations and emergency department visits. Many of these reports have     restricted studies to patients with specific diseases or general characteristics; some have     shown improved results while others have not. No study has examined patients who are high     risk for readmission to determine if home telemonitoring for 30 days post-discharge reduces     the risk for 30-day readmission.   "
87851|NCT02136173|"     The effect of the balloon on weight loss is investigated by multiple studies. However, the     effect of the sequential balloons is not studied yet.   "
88034|NCT02133768|"     To describe the need for re-catheterization and incidence of urological complications of     routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track     THA and TKA   "
87853|NCT02136147|"     ADHD medication of children and adolescents is becoming increasingly common. Clinical     experience and scientific studies have proven that approximately 30% of children/adolescents     with ADHD do not benefit from this treatment. However, there is insufficient knowledge about     who these children are. All children and adolescents, who start treatment with ADHD     medication at public Child and Adolescent Psychiatry units in Stockholm and on Gotland, will     be asked to participate in the study. The investigators intend to monitor the     patients´clinical symptoms and possible side-effects after treatment start. The investigators     will collect background information and saliva samples from the patient and his/her parents     to be able to study if there are any genetic (hereditary) or other markers that can predict     positive or negative outcomes of the ADHD medication. With this information, the     investigators aim at, to a greater extent, be able to individualize treatment choices for     children and adolescents with ADHD without unnecessary, costly and possibly unfavorable     treatment attempts.   "
87854|NCT02136134|"     The purpose of this study is to assess the effects of administration of daratumumab when     combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and     dexamethasone alone, for participants with relapsed or refractory multiple myeloma.   "
87855|NCT02136121|"     To determine the feasibility of representative urologic procedures as measured by the rate of     conversions   "
87856|NCT02136108|"     The OPEN study has two aims: The first is to identify what helps to keep patients involved     with a Medicaid chronic pain management program and to identify features of an ideal     text-message-based program for people enrolled in the program. The second aim is to develop     the text-message-based program (OPENtext), then find out how useful this intervention is     compared to a patient navigator intervention (OPENnav) for increasing patient engagement,     improving patient's motivation to manage their chronic pain, and improving patient confidence     in self-managing their chronic pain condition.   "
87857|NCT02136095|"     Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is     a recently developed method for non-invasive visualisation of the relevant anatomy during     laparoscopic cholecystectomy. The objective of this study was to assess the time required by     routine-use of IFC and to evaluate success-rate of the procedures.      Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the     same surgeon were consecutively enrolled. A standardized protocol with IFC including     concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative     time-registration and exposure of predefined anatomical structures were recorded.   "
87858|NCT02136082|"     Building upon the successful qualitative Phase I of the study, Phase II commences in month     10. The Project manager and research staff will recruit 600 women living with AIDS (WLA) and     their oldest child between the ages of 3 and 8. The WLA will be recruited from Primary Health     Centers (PHCs) randomly selected from 72 closest PHCs in terms of HIV prevalence in the rural     Andhra Pradesh (AP) area of Nellore. WLA will be recruited by means of approved flyers posted     in selected PHCs. Interested WLA will approach the research staff, stationed at the PHC to be     screened for eligibility via a consent script. Once eligibility is determined for the WLA,     based upon the following criteria: age, HIV and ART status (validated by ART and HIV card);     having a child (3-8 years) and whether or not the WLA was a participant of the previous     intervention group from the Asha pilot study, a parental consent will be obtained from the     WLA for permission to include her oldest child in the study. The oldest child between 3-8     years of age will be brought in to the research office or PHC (after mother speaks with the     child at home). All children will have blood work drawn and physical health assessment on     their first visit (total of 15 minutes). All eligible WLA will undergo a second consent for     enrollment. General Procedure: Following informed consent, the WLA will be randomly assigned     into one of four programs 1) Asha Support Only; 2) Asha Support + Training; 3) Asha Support +     Food; or 4) Asha Support + Training + Food. After blood draw and physical assessment of the     WLA, an appointment will be made for the assigned interviewer (blinded to program) to visit     the WLA at their home preferably (or other location of choice) to conduct several 24 hour     dietary assessments. Urine will be collected in labeled bottles on the morning after the 3rd     day of the diet recall by the interviewer and sent directly to the lab in a cooler. Also, on     the same day, the baseline assessment will be entered into the PC tablets; 50 minutes     estimated with breaks). After a longer break, the WLA will then be asked to respond to     additional questions about the sociodemographic and psychomotor development of their child     (about 30 minutes). Interviewers will visit the WLA monthly until the end of the intervention     (month 6) to provide individual weekly Asha Support and conduct group sessions and collect     ongoing data, 24-hour recall, and ART pill count for WLA, and follow up questionnaires at 6-,     12- and 18-months.   "
87859|NCT02136069|"     This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group     study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with     infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are     naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1     ratio to receive either etrolizumab 105 (milligrams) by subcutaneous (SC) injection [SC]     every 4 weeks [Q4W]) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then every 8     weeks) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then every 8     weeks) + placebo (SC Q4W). Time on treatment is 54 weeks.   "
87860|NCT02136056|"     The purpose of the current study is to determine the efficacy of a self-management course for     workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment     as usual). Outcomes are registry based measures of return to work, and questionnaire based     measures of well-being and quality of life.      We thus, hypothesize that the program will improve workers return to work rates and     self-reported/psychological well-being.   "
87861|NCT02136043|"     The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation     (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize     any patient reported discomfort during treatment procedure.   "
87862|NCT02136030|"     To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B     deoxycholate with or without flucytosine followed by fluconazole for the treatment of     cryptococcal meningitis.   "
87863|NCT02136017|"     To evaluate the safety of the post-licensed influenza virus vaccine made of Changchun     Institute of Biological Products Co.,Ltd.   "
87864|NCT02136004|"     The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical     Closer Vascular Sealing System in sealing femoral arterial access sites.   "
87865|NCT02135991|"     Young people can engage in a variety of negative behaviors—such as drug use, underage     drinking, and premarital sex—that exact a high toll on local communities. These activities     are often the target of community-based prevention efforts. Getting To Outcomes (GTO) is an     approach that includes a toolkit, technical assistance, and training, organized around a     10-step process, that helps communities plan, implement, and evaluate the impact of their     programs that attempt to prevent these negative behaviors. This study will examine the degree     to which Getting To Outcomes helps Boys and Girls Clubs implement an evidence based drug     prevention program.   "
87866|NCT02135978|"     The purpose of this study is to determine if a shoulder exercise program can prevent the     onset of shoulder pain and improve community participation in persons who have a spinal cord     injury (SCI). Upon entry into the study patients will have pain-free shoulders and will be     followed for 3 years to determine rate of shoulder pain development. Patients will learn a     simple shoulder home exercise program and will be instructed on techniques to protect their     shoulder during wheelchair propulsion, transfers and activities of daily living. Patients     will be instructed to perform the home exercise program 3 days per week. Two types of     treatment (training) delivery approaches that have been documented to reduce chronic shoulder     pain will be compared. The rate of shoulder pain development for the two groups will be     compared to the rate of shoulder pain development in the historical control group. The     investigators hypothesize that the rate of shoulder pain development will be lower in the     experimental treatment groups compared to the historical control group. Any differences     between the two treatment delivery approaches for the experimental treatment groups will help     to provide guidelines for the most effective delivery approach of a shoulder pain prevention     program.   "
87867|NCT02135965|"     The purpose of this study is to define a ratio of Caffeine and albuterol that gives a     synergistic increase in metabolic rate.   "
87868|NCT02135952|"     Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic     and oral complications, such as periodontitis. The use of adjunctive local and/or systemic     antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling     and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and     amoxicillin (AMX) has been largely recognized as an effective therapy for improving the     clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis     (ChP). However, no previous clinical trials to date have evaluated the effects of this     antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore,     the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and     microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2     diabetic subjects with generalized ChP.   "
87982|NCT02134457|"     This study is designed as an exploratory study to assess safety and efficacy of two different     doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants     with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment     of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal     injection in neonates.      The primary objective is to assess clinical efficacy of ranibizumab in children with ROP   "
87875|NCT02135861|"     Transient receptor potential vanilloid 4 (TRPV4) channel blockade may be promising in the     treatment of pulmonary oedema and dyspnoea in heart failure (HF) and acute decompensated     heart failure (ADHF) patients by re-establishing the alveolar septal barrier. Dynamic     contrast enhanced (DCE) Magnetic Resonance Imaging (MRI) is an established technique for     assessing changes in vascular permeability and interstitial water volume. The aim of this     study is to establish the potential utility of DCE-MRI as a novel endpoint for dose ranging     and proof of mechanism studies of TRPV4 blockers. The DCE-MRI markers of vascular     permeability and pulmonary oedema will be measured in subjects with HF (group 2) and healthy     volunteers (HV) (group 1) at rest to determine if there is a difference between the two     populations. Apart from this, exercise induced changes relative to rest in interstitial     volume and exchange rate will be evaluated in both HV and subjects with HF. Additionally, the     capability of DCE-MRI to detect changes in interstitial lung fluid in patients with acute     decompensated heart failure (ADHF) (group 3) will be investigated. DCE-MRI markers of     pulmonary oedema will be assessed when patients are initially hospitalized with ADHF and     subsequently after receiving standard of care treatment to determine whether differences can     be detected by this methodology.This study will enrol a sufficient number of subjects to have     at least 24 subjects in Group 1 and 2 (group 1:12 HV and group 2: 12 subjects with HF) and     atleast 5 subjects in Group 3. For each subject, the MRI data must be of sufficient quality     to enable DCE-MRI modelling from 2 Sessions. For group 1 and 2, the subjects will have     screening visit and 3 MRI sessions. For the first scanning session, subjects will undergo the     baseline procedure. The second imaging session will occur approximately one week later to     measure within subject variability. A third imaging session (which will be conducted in 2     visits) will incorporate a bicycle exercise challenge prior to the MRI scan, and this third     scan will be performed approximately one to three days after the second imaging session. For     group 3: Screening will occur during hospitalization for eligibility. Session 1of MRI will be     conducted while the subject is still hospitalized. Session 2 will be conducted within 4 weeks     of the first scan, when the signs of pulmonary oedema are considered to be resolved. If a     subject's pulmonary oedema has not resolved at Session 2, then the subject will be not be     scanned by MRI at Session 2 and will be brought back for Session 3 up to 4 weeks after     Session 2 for their second MRI.   "
87876|NCT02135848|"     This is a multi-center, randomized, blinded, placebo controlled study to evaluate the safety     of GSK1278863 and its acute and short-term (e.g. 14d) effects on calf muscle endurance and     walking ability in subjects with PAD and symptomatic claudication.   "
87877|NCT02135835|"     The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in     patients with acute heart failure.   "
87878|NCT02135822|"     The purpose of this study is to determine the efficacy and safety of nanoparticle     albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine as first-line treatment in Chinese     patients with advanced pancreatic ductal adenocarcinoma.   "
87879|NCT02135809|"     The purpose of this study is to document the performance of a new Fully Covered Self     Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in     patients with painful chronic pancreatitis.   "
88059|NCT02133443|"     Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains     challenging, and several methods have been suggested. However none of them seems easily     utilisable. Thus the investigators propose to test a way of NAVA level titration according to     ventilator comfort.   "
87880|NCT02135796|"     The investigators hypothesize that not all patients with severe sepsis or septic shock with a     Central Venous Oxygen Saturation (ScvO2) less than 70% have cardiac dysfunction that would     benefit from inotropic therapy (a key strategy in early goal directed therapy in patients     with sepsis). Echocardiography might show that despite an adequate Central Venous Pressure     (CVP), intravascular volume status is low and further volume expansion is warranted.     Alternatively, echocardiography may indicate that left atrial pressure is elevated, and     further intravascular volume resuscitation should be limited. Such observations may lead to a     role for echocardiography within the parameters of the early goal-directed therapy protocol     that may improve treatment of cardiac dysfunction and hypovolemia.      The study objective is to correlate echocardiographic findings with objective parameters,     namely central venous pressure (CVP) and central venous oxygen saturation (ScvO2), measured     during the early resuscitation of critically ill patients with severe sepsis and septic     shock.      Aim #1: Correlate echocardiographic findings of right ventricular (RV) systolic function and     dilation, left ventricular (LV) systolic function and dilation, and left ventricular     diastolic function with CVP and ScvO2 in the early hours of resuscitation in patients with     severe sepsis and septic shock.      Aim #2: Evaluate the change in RV and LV dysfunction over time in patients with severe sepsis     and septic shock and correlate with mortality.      Aim #3: Evaluate the efficacy of bedside echocardiography performed by the intensivist in the     ICU in the evaluation of patients with severe sepsis and septic shock.   "
87881|NCT02135783|"     Decompressive craniectomy has been reported for the treatment of patients with intracerebral     hemorrhage. But no prospective randomised controlled trials have yet been undertaken to     confirm its effect.The purpose of the study is to determine whether decompressive craniectomy     post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a     person dying or surviving with a long term disability.   "
87882|NCT02135770|"     Sepsis is a clinical syndrome which infection trigger systemic inflammatory response.     Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early     mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used     either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin     also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor     necrosis factor alpha.      Aim of this study is to determine effects of low dose unfractionated heparin treatment on     inflammation in severe sepsis patient.   "
87904|NCT02135471|"     Smoking has a negative effect on the predictability and stability of root coverage procedures     because of decreased blood supply and fibroblast activity. Long-term evaluation of this     procedure in smokers is important for clinical decision making, because it provides     information about the stability of results over time. In smokers, enamel matrix derivative     (EMD) used at acellular dermal matrix graft (ADMG)/ soft tissue interface could be an     alternative to improve the deficient healing potential, since EMD has the capability of     stimulating angiogenesis. At the ADMG/ root surface interface, it could improve the deficient     fibroblast activity in smokers and therefore reduce the presence of a long junctional     epithelium. The aim of this randomised controlled clinical study was to investigate whether     EMD contributes to the root coverage of gingival recessions performed with ADMG in smokers     during a 12-month follow-up.      Twenty smokers with bilateral Miller Class I or II gingival recessions ≥ 3 mm will be     selected. The test group will be treated with an association of ADMG and EMD, and the control     group with ADMG alone. Some clinical parameters as: probing depth, relative clinical     attachment level, gingival recession height, gingival recession width, keratinized tissue     width and keratinized tissue thickness will be evaluated before surgery and after twelve     months.   "
93023|NCT02068495|"     This study will investigate the safety and efficacy of long-term use of candesartan     cilexetil/amlodipine combination tablets (Unisia Combination Tablets) LD, HD in patients with     hypertension in the normal clinical setting.   "
87883|NCT02135757|"     This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact     and resistance mechanisms of panitumumab in the treatment of patients with     chemotherapy-refractory metastatic colorectal cancer (mCRC).      This study will address two anticipated issues surrounding personalized medicine and     treatment with panitumumab. First, it will enable to assess the economic impact of     panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based     mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic     colorectal cancer (Blood study).      The primary objective is to collect information on quality of life and health care resource     utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives     are to confirm survival data, to assess the quality of life of patients and to assess the     health care resource utilization of patients. The blood biomarker study objective is to     determine blood-based biomarkers of response or resistance to panitumumab.      Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will     participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be     treated with panitumumab and will participate to the HEOR study and to the blood biomarker     study.      During the course of the study, data will be collected on quality of life and work     productivity. Patients will be asked to fill a set of questionnaires at their recruitment in     the study and at every 3 months after treatment initiation. For patients participating to the     blood study (patients with a wild type KRAS), blood samples will be collected before patients     start their treatment, at every treatment and when they discontinue their treatment.   "
87884|NCT02135744|"     Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease     (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to     determine whether a screening and educational tool, administered prior to discharge, would     result in a decrease in the rate of hospital readmissions.   "
87885|NCT02135731|"     We are studying patients' abilities to correctly identify the prescription medications they     are taking. We are interested in understanding what tools will help patients correctly     identify their medications. People participating in this study will be asked to either review     a paper printout of their medication list or a computer program with their medications. The     program will show the names and pictures of the medications. In either situation,     participants will be asked to indicate if they are taking the medications as prescribed. We     will then compare reported adherence between each medication review process. Participation     may help the program developers improve the product.   "
87886|NCT02135718|"     This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with     asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers     (MDI). This study is conducted to evaluate subject's preference of several inhaler-specific     attributes individually between an existing MDI and the ELLIPTA a dry powder inhaler.     Subjects who have not used the ELLIPTA inhaler in the past 6 months and their asthma must be     controlled on their current therapy were enrolled. Subjects meeting the eligibility criteria     will be stratified according to their current inhaler use (stable for the past 3 months): 1.)     Currently using a DPI as an inhaled asthma controller therapy OR 2.) Currently using an MDI     as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months) OR 3.)     Currently using no inhaled asthma controller therapy (this includes patients using a LTM     and/or SABA only). Once stratified, eligible subjects were randomized (1:1) to one of two     sequences for using the inhaler: ELLIPTA inhaler once daily in Period 1 followed by MDI twice     daily in Period 2 or MDI twice daily in Period 1 followed by ELLIPTA inhaler once daily in     Period 2 for for 5-9 days each. In addition, subjects will be randomly assigned (1:1     allocation) to receive one of two sets of questions: Version 1 presents response options in     the order of ELLIPTA inhaler, MDI, No preference; Version 2 presents response options in the     order of MDI, ELLIPTA inhaler, No preference. At the end of the second trial period, subjects     answered questions which assessed their preference of inhaler attributes. ELLIPTA is a     registered trademark of the GSK group of companies.   "
87889|NCT02135679|"     Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be     enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will     collect demographic and treatment data and explore & describe the pattern of CTC detection in     all patients   "
87890|NCT02135666|"     The purpose of this study is to assess the long-term persistence of immunity to hepatitis A     and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and     hepatitis B vaccine, Twinrix.   "
87891|NCT02135653|"     This study will ascertain the feasibility and effect of Eischens yoga interventions on     radiationrelated fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate     cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy.     Subjects must be smoke free and have not taken regular yoga classes 6 months prior to     enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete     4 quality of life forms 5 times during study.   "
87892|NCT02135640|"     This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of     denosumab administered subcutaneously to healthy adults in China.   "
87905|NCT02135458|"     Heart failure is the principle cause of hospitalisation for people over 65. the assumption is     that a system of home based telemonitoring can reduce the rate of unscheduled hospitalisation     or rehospitalisation for heart failure (compared to a care package alone), This randomised     controlled pilot study should assess the feasibility in terms of patient inclusion and     follow-up.   "
87906|NCT02135445|"     The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and     maintaining testosterone suppression.   "
87907|NCT02135432|"     The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of     orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease.     Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (BID).   "
87908|NCT02135419|"     This randomized phase III trial compares topical or ablative treatment with active monitoring     in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade     squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been     damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal     cancer. It is not yet known if treating HSIL is more effective than active monitoring in     preventing patients from developing anal cancer.   "
87893|NCT02135627|"     Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly     recognized as a result of oncological advances and improved detection methods, and stems from     local vessel damage and tumor invasion with associated derangements in the hemostatic     system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB     due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps     the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal     neoplasms are scarce and associated with varying success in initial hemostasis and high     rebleeding rates(3-7). Other recognized single or multimodality treatment approaches include     radiation therapy, interventional angiography, and surgery. All exhibit disappointing     rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). Challenges     associated with bleeding tumors include hematological derangements such as thrombocytopenia,     disseminated intravascular coagulation, and neutropenia, as well as the endoscopic     manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13).     The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as     TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for     this refractory clinical entity, with promising uncontrolled observations having just been     published by our group(13) and others(14). More robust controlled evaluative data are now     needed. We propose to study the use of TC-325 in upper and lower malignant GI bleeding     compared to contemporary standard of care, and more specifically seeks funding for a pilot     study to inform a subsequent peer-review application for a larger, more definitive randomized     clinical trial (RCT).   "
87894|NCT02135614|"     This study is to evaluate the antiviral effect, pharmacokinetics, safety, and tolerability of     presatovir in respiratory syncytial virus (RSV) positive adults who have been hospitalized     with acute respiratory infectious symptoms.      Participants will receive 1 dose of presatovir and followed for 28 days postdose. Nasal swabs     will be collected at each study visit (excluding Day 28) and assayed for change in viral load     as the primary endpoint.   "
87895|NCT02135601|"     Water exchange method has been shown to reduce medication requirement and pain experienced     during colonoscopy. It may increase the adenoma detection rate (ADR). Water exchange provides     salvage cleansing and the refractive index of water (n equals about 1.3) is larger than that     of air, which creates optical distortion that likely contributes to objects appearing larger     underwater, making smaller lesions easier to visualize and it may help draw attention to     those smaller lesions during withdraw. These principles facilitate to the higher adenoma     detection rate.      There is a large number of literature on the adenoma detection rate during water exchange     colonoscopy, but most studies have been conducted in only one centre, simple-size, and under     sedation patients, the influence of adenoma detection rate under unsedation patients was     unclear.      The aim of this study is to compare the ADR of colonoscopy by using the water exchange method     versus the conventional air method in unsedation patients in multiple centers in China.   "
87896|NCT02135588|"     The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa     and tPA administered to patients with clinical failure of small-bore chest tube with     persistent pleural effusions or malignancy-related loculated effusion to improve pleural     drainage.   "
87897|NCT02135575|"     The hypothesis of the present study is that physical training can oppose detrimental changes     in cardiovascular and metabolic health associated with estrogen loss after menopause.   "
87898|NCT02135562|"     This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for     weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in     carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of     only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein     requirements based on the individual's body weight. The PSMF may help endometrial cancer     survivors achieve significant weight loss, reduce the risk of chronic disease, and improve     quality of life.   "
88060|NCT02133430|"     The purpose of this study is to compare the difference of incidence of postoperative delirium     between patients received general anesthesia guided by Bispectral index (BIS) and patients     received general anesthesia using standard technique.   "
87901|NCT02135523|"     1. Title: The efficacy of involved-field radiation therapy for residual or locoregionally          recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional          phase 2 clinical trial        2. Study period: 2014.04~2018.04        3. Objective: To determine whether involved-field radiation therapy will prove to be          improve 2-year progression free survival for residual or locoregionally recurrent          epithelial ovarian cancer patients after definitive treatment.        4. Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)        5. Planned number of patients             -  YUHS database have 149 FIGO stage III patients treated with debulking surgery and               adjuvant platinum-based chemotherapy 2.             -  Of these patients, 90 patients experienced locoregional failures, and then the               investigators selected 44 patients who could be treated effectively with IFRT based               on MDACC suggestion.             -  Median interval to failure was 9 months in these patients             -  Hypothesis; IFRT reduces 30% hazard of progression compared with patients without               IFRT             -  Sample size; two-sided, accrual time = 24 mo, f/u time= 36 mo. α= 0.05, power =               0.80 Null progression-free median survival = 9 mo Alt progression-free median               survival = 13 mo Calculated sample number = total 64 patients Drop rate = 10% •               Total sample number = 70 patients        6. Radiation therapy: Participants will receive involved-field radiotherapy (external beam          radiotherapy or brachytherapy) over 45Gy with 1.8-2.0 Gy fraction, five times per week          for residual or locoregionally recurrent epithelial ovarian cancer after definitive          treatment             -  Target volume                  -  directed to gross disease plus a high-risk clinical target volume (CTV) that                    included the postoperative bed or the prechemotherapy extent of disease with a                    1- to 1.5-cm margin, excluding uninvolved clinical structures                  -  Additional CTVs were designated according to the risks of microscopic disease                    spread, proximity to critical structures, and other risk factors for                    complications.                  -  Nodal CTVs included grossly involved lymph node sites, extending to cover                    adjacent uninvolved regions.             -  Modality; 3-dimensional conformal RT including electron, intensity-modulated RT,               proton beam RT        7. Patient assessment: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after          radiation therapy        8. Key words: ovarian cancer, involved-field radiation therapy, progression free survival   "
87902|NCT02135510|"     In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and     palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard     to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by     non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy     (MEC).   "
87903|NCT02135484|"     The goal of this clinical research study is to learn more about how the study drug alpharadin     (Radium-223) works in patients who have CPRC that has spread to the bone.   "
88699|NCT02125084|"     The purpose of this study is to determine the safety and efficacy of a novel combination of     agents, enzalutamide and everolimus, for the treatment of patients with metastatic     castrate-resistant prostate cancer who have never received prior chemotherapy, or who have     previously received docetaxel chemotherapy and have progressive disease.   "
87911|NCT02135380|"     Despite intense research efforts and clinical trials, there is still no effective treatment     that can prolong the survival of patients with IPF. Conventional therapeutic approach     includes combination of corticosteroids, anti-oxidants, immunodepressants and immune     modulatory anti-fibrotic agents to be discontinued 20 days before screening. The only, so     far, therapeutic approach that has been proven effective in terms of prolonging patient's     survival is lung transplantation. Nonetheless, not all the patients with IPF are eligible for     lung transplantation; there is a significant proportion of these patients that finally     succumb while waiting in a lung transplantation list. Therefore, there is critical need for     more effective and reliable therapeutic modalities5. Adult Stem Cells (ASCs) seem to     represent one of these. Therefore, it is conceivable to assume that adult-stem cells can be     easily and safely be applied as a novel therapeutic agent in chronic and fatal lung diseases,     including chronic obstructive pulmonary disease (COPD) and IPF.      Therefore, there is an urgent need to provide a safe, effective and affordable treatment     option for IPF patients. New diagnostic, prognostic and therapeutic strategies need to be     developed to reduce the burden of IPF. Given the present lack of appropriate treatment     adjunctive in the therapy of IPF, adipose derived stromal vascular fraction provides new     opportunities for development of the same.      MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary     fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic     pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules     involved with cell attachment to neighbouring cells and to the extra cellular matrix.18 This     cell surface configuration may enable mesenchymal stem cells to home from bloodstream to     mesenchymal tissue.14      As limited clinical information is available about use of SVF and MSC in the IPF patients     hence this Open Label, Prospective, Randomized multi center comparative study has been     undertaken to explore the tolerability & effectiveness of SVF in one treatment arm and MSC in     second treatment arm in IPF patients.      Adipose derived stromal vascular fraction and Mesenchymal Stem Cells has been found in     preclinical studies to be safe and effective   "
87912|NCT02135367|"     The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP)     to treat knee degenerative articular cartilage pathology could determine pain relief and     recovery of knee function with overall clinical outcome comparable or even better than     viscosupplementation, which is a common injective approach applied in this kind of pathology.     To this purpose the investigators designed a double blind randomized controlled trial     comparing PRP vs viscosupplementation.      A power analysis has been performed for the primary endpoint of IKDC subjective score     improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of     15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal     clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean     improvement, the minimum sample size was 83 for each group. Considering a possible drop out     of 15%, 96 patients per group are required for total 192 patients, selected according to     well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then     assigned to two different treatment groups, according to a randomization list. The first     group of treatment consists of three weekly intra-articular injections of autologous PRP     obtained with the following procedure: a 150-ml autologous venous blood sample undergoes 2     centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second     at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of PRP. This unit of     PRP is then divided into 4 small units of 5 ml each. One unit is sent to the laboratory for     analysis of platelet concentration and for a quality test, 3 units are stored at -30° C.      The second treatment group consists of patients receiving three weekly injections of     hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500     kDa).      To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain     autologous PRP which will be used only in half of them, according to the aforementioned     randomization list. One week after the PRP production, the injective treatment starts, with 3     weekly injections of PRP or HA. At the moment of the injection the syringe is properly     covered to prevent the patient from discovering the substance he was receiving. After the     injection, patients are sent home with instructions to limit the use of the leg for at least     24 h and to use cold therapy/ice on the affected area to relieve pain. During this period,     the use of non-steroidal medication is forbidden.      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using     clinical subjective scores and objective parameters to determine clinical outcome (see     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.     All the clinical evaluations are performed by a medical staff not involved in the injective     procedure, in order to keep the study double blinded. At the end of the study, the nature of     the injected substance is revealed to the patients.   "
87913|NCT02135354|"     This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled     multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of     azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission.     Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent     risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment     and by restricting the treatment to acute periods with highest risk for treatment failure,     benefits may counterbalance potential side effects, which may result in a new treatment     strategy for these acute events.      The present study is designed by the services of respiratory medicine of the Leuven and Ghent     University hospitals but will run in total in 17 different large hospitals in Belgium, of     which 12 are located in Flanders.   "
87914|NCT02135341|"     The objectives of this study is to evaluate and compare the efficacy and safety between 100 U     of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A     suburothelial injections and 50 U urethral injection for the treatment of detrusor     overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents   "
87915|NCT02135328|"     The purpose of this study is to use a community based participatory action research (CBPAR)     approach to 1) create radio stories about Somali, Latino and Hmong families' real success     stories with type 2 diabetes mellitus (DM) in managing their disease through implementation     of healthful lifestyle behaviors (nutrition and physical activity), and 2) test the     effectiveness and acceptability of radio stories on participant intentions to engage in or     improve healthful lifestyle behaviors. Participants in the Intervention condition listened to     the radio stories and the participants in the control condition listened to an audio     brochure with relevant information. We hypothesized that the intervention participants would     report higher intensions to engage in various healthful lifestyle behaviors than the control     participants after both participants listened to their respective health information.   "
87916|NCT02135315|"     The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24     hours can improve the prognosis in the short and long term.      We confront two treatment strategies (standard and intensive treatment) to evaluate their     superiority in the treatment of acute coronary syndrome.   "
87917|NCT02135302|"     This is a multi-center, open-label clinical study to assess the single-dose PK of     eravacycline in subjects with hepatic impairment and healthy subjects conducted at     approximately 3 sites in the United States. This study includes an up to 21-day Screening     Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks     (± 2 days) after initiation of study drug administration. Approximately 24 subjects will be     enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for     each of the 3 Child-Pugh categories of mild [5 - 6 points], moderate [7 - 9 points], and     severe [10 - 15 points]) and 6 healthy subjects without hepatic impairment. Healthy subjects     will be matched to hepatically impaired subjects in gender, age, and body mass index (BMI).     All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).   "
87918|NCT02135289|"     Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID     patients treated with anti-TNF can be a serious problem. This study aims to investigate the     role of IGRA in screening for latent TB in IBD patients and control subjects. In part II of     the study, patients of other immune-mediated inflammatory diseases (IMID) will also be     included to investigate the role of serial interferon-gamma release assays (IGRA) for the     diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory     diseases (IMID) treated with biologics   "
87919|NCT02135276|"     This is a multi-center, open-label clinical study to assess the single-dose PK of     eravacycline in subjects with renal impairment and healthy subjects conducted at     approximately 2 sites in the United States. This study includes an up to 21-day Screening     Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks     (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6     subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will     be matched to renally impaired subjects in gender, age, and body mass index (BMI). All     subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).   "
87920|NCT02135263|"     The purpose of this study is to determine whether differences in the gene coding for the     liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of two CES1     dependent drugs, enalapril and methylphenidate.   "
87921|NCT02135250|"     This study aims to discuss whether the combined treatment of traditional Chinese medicine     (TCM) and western medicine for Mental Stress Induced Myocardial Ischemia (MSIMI) does effect,     namely the conventional therapy for Coronary Heart Disease( CHD) combining with TCM -     Xinkeshu tablets.   "
88700|NCT02125071|"     An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig     injection used for prevention of hepatitis B relapse after liver transplantation.   "
87922|NCT02135237|"     Contingency management (CM) treatments are highly efficacious in improving outcomes of     substance abusing patients. However, CM has rarely been applied to individuals with alcohol     use disorders, primarily because of technological limitations in monitoring drinking. The     Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to     continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of     this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total,     120 alcohol abusing or dependent patients initiating outpatient treatment at community-based     clinics will be randomly assigned to one of two conditions: standard care, or standard care     plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care,     it is expected that CM will result in fewer drinking days and longer durations of continuous     non-drinking days.   "
87923|NCT02135224|"     The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and     possibly result in a shorter duration of vaginal delivery.   "
87924|NCT02135211|"     The objective of this proposal is to test the feasibility and acceptability of a lifestyle     risk reduction intervention for patients with lung cancer receiving surgical treatment. This     study will provide the preliminary data needed to conduct a larger randomized controlled     trial that tests an innovative, multidisciplinary intervention that has the potential to     transform the standard of care for patients receiving surgical treatment for lung cancer.   "
88061|NCT02133417|"     Conduct a case collection study of breast imaging examinations from women with     mammographically-detected breast lesions for the purpose of conducting subsequent Reader     Studies.   "
87925|NCT02135198|"     GABA (gamma-aminobutyric acid) is the main inhibitory compound in the human brain. Drugs that     enhance its effects by binding on GABA receptors (e.g., benzodiazepines) are used to treat     various diseases such as epilepsy, insomnia, anxiety or movement disorders. However, the use     of these medications is often compromised due to their side effects, like sedation, cognitive     impairment, and addiction.      Many of these side effects have been linked to a particular type of GABA receptor (GABA A     alpha 1). Therefore, effort is being made to develop drugs that do not act on this receptor,     but maintain their beneficial properties by acting on other types of GABA receptors. AZD7325     is a drug that selectively acts on GABA A alpha 2 and A alpha 3 receptors, but not A alpha 1.     It has been tested in more than 700 people and so far proved to be generally well tolerated.     Positron emission tomography (PET) study in humans demonstrated that AZD7325 binds to GABA A     receptors in the brain after a single dose. Early clinical studies have shown that it has     less sedative and cognitive adverse events as compared with a benzodiazepine lorazepam.      In this study, we will investigate its effects on short interval intracortical inhibition     (SICI). SICI is neurophysiological marker of inhibitory processes in the motor cortex. It is     obtained non-invasively by using transcranial magnetic stimulation (TMS). In TMS, magnetic     impulses applied over the scalp that in turn induce a current in a small area of the brain.     If applied over the motor areas of the brain, impulses result in muscle twitch that is     recorded with surface electrodes. SICI is enhanced by certain drugs like benzodiazepines that     act on GABA A alpha 1,2,3, and 5 receptor subtypes, but not by zolpidem acting solely on     alpha 1 subtype. Because GABA A alpha 5 receptor subtype is less common in the cortex, it has     been concluded that the drug effects on SICI are related to GABA A alpha 2 and alpha 3     receptors.      If AZD7325 proves to enhance SICI in healthy volunteers, this would create the grounds for     the use of this medication to treat certain neurological disorders in which SICI has been     found to be impaired (e.g., dystonia).   "
87926|NCT02135185|"     Improvement exercise tolerance   "
87927|NCT02135172|"     The number of people diagnosed with Type 2 diabetes (T2DM) is increasing rapidly and about     2.9 million people in the UK currently have diabetes. There is increasing evidence suggesting     that prolonged sedentary time may actually increase the risk of diabetes and other chronic     diseases. Importantly, adults can meet public health guidelines on physical activity (150     minutes of moderate activity per week), but if they still sit for prolonged periods, their     metabolic health is compromised. Going from sitting to standing and carrying out     light-intensity activities (such as casual walking) may reduce diabetes risk. However, no one     has investigated the effect of standing and walking on markers of cardio-metabolic markers in     individuals with a high risk of T2DM. Therefore, the aim is to find out whether reducing the     amount of time people spend sitting and replacing it with standing and light intensity     activity (walking) reduces glucose, insulin and triglyceride levels, therefore reducing the     risk of diabetes.   "
87928|NCT02135159|"     The purpose of this study is to determine the optimal sequences of combined trastuzumab     emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from     HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1     pharmacokinetics.   "
87929|NCT02135146|"     The purpose of this study is to conduct a prospective, randomized, controlled trial comparing     a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive     perioperative fluid has been retrospectively implicated in the development postoperative     acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid     restriction in these patients is not without risk and may compromise end organ perfusion     (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic     surgery patients will result in better end organ perfusion with fewer occasions of acute     kidney injury (AKI) without causing an increase in postoperative acute lung injury or     pulmonary edema.   "
87930|NCT02135133|"     This research study is evaluating a combination of drugs called Ofatumumab and Idelalisib as     a possible treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia     (SLL).      The main purpose of this study is to examine the combination of the two drugs, Ofatumumab and     Idelalisib, in participants who have been diagnosed with CLL/SLL and have not previously     received treatment but do require treatment. The investigators hope to observe how     participants' disease will be impacted by this treatment and whether they will benefit more     from combining these drugs together rather than taking them separately. Both of these drugs     have been used in treatment for CLL / SLL and information from those research studies     suggests that these drugs may help patients with CLL/SLL.      Ofatumumab is an antibody engineered in the lab against CD20, a protein on the surface of CLL     cells, which is expressed in CLL. An antibody is a molecule your body creates to identify     foreign substances so that it can destroy them. Ofatumumab has been FDA approved for     treatment of CLL/SLL that has relapsed or progressed on other therapies. Idelalisib is a drug     that blocks one of the signals inside the cells that cause this type of cancer to grow and     survive. The investigators hope that combining Ofatumumab with Idelalisib will stop the     growth of disease.      In this research study, the investigators are evaluating the side effects of combining these     two drugs, gathering information on the CLL/SLL disease process and how the study affects the     patient's cells, as well as assessing the outcome of the disease. This combination of drugs     has been previously tested, and appeared to be well tolerated.   "
87933|NCT02135094|"     The purpose of this study is to measure the effectiveness of a wearable therapeutic     ultrasound device for relief of pain associated with the trapezius muscle of the upper back     over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers     most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound     device will lower the reported daily pain level of subjects suffering from trapezius muscle     pain in their upper back.      Subjects who participate in the study will self-administer the ultrasound device beginning at     the onset of trapezius muscle pain, which is defined as a score of 3.0 or higher on a scale     of 1-10. Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4     for a total of 3 visits. Subjects will report their daily pain levels in a diary.      The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of     joint contracture, relief of muscle spasm, and increased circulation.   "
87934|NCT02135081|"     This study seeks to determine cerebral blood flow changes in single ventricle patients during     staged surgical reconstruction as compared with normal children. Two general groups of single     ventricle patients will be recruited for this study, corresponding to the two approaches     used. An aged-match group of healthy subjects will be included as a control.   "
87936|NCT02135055|"     ICU patients always experience all kinds of pain, discomfort and sleep disturbance,especially     the sepsis patients. Appropriate sedation and analgesia is must,the newest sepsis guideline     strongly recommend that mechanically ventilated sepsis patients need sedation therapy.      Recent studies show than immune dysfunction dose have an important effect on the occurrence     and development of sepsis. When the body suffer from the pathogenic microorganism attacking     and sepsis, it activate the systemic inflammatory response (SIRS) and compensatory     anti-inflammatory response syndrome (CARS). When it is out of balance between SIRS and CARS,     the inflammatory response, immune paralysis or immune dysfunction occurs and the mixed     anti-inflammatory response syndrome (MARS) exists, and then the multiple organ dysfunction.     So, immune dysfunction is thought to be the key factors on the development of the sepsis.     Some studies show that the sedation drug such as midazolam, propofol, dexmedetomidine could     suppress the inflammatory response effectively and then modulate the immune function.      Several recent studies show that midazolam has the immunoregulation effect and trend of     suppress the inflammatory response, but the result is controversy, the possibly reason is the     different immune status. Now there is the guideline about the different immune status: the     normal immune function means that the value of mHLA-DR is more than 15000 monoclonal     antibody; moderate-sever immune suppression means that the value of mHLA-DR is in the range     of 5000 and 15000 monoclonal antibody; the immune paralysis means that the value of mHLA-DR     is less than 5000 monoclonal antibody.      The purpose of the study is to explore the effect of midazolam to inflammatory response and     organ function at mechanically ventilated sepsis patients who have different immune status.   "
87937|NCT02135042|"     There are two study questions we are asking in this randomized phase II/III trial based on a     blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally     advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard     concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if     there is no detectable EBV DNA in their plasma, then patients are randomized to either     standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still     detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and     fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high     energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin,     fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil     is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in     treating patients with nasopharyngeal cancer.   "
87938|NCT02135029|"     This study is a multicenter, double blinded, active and placebo controlled randomized     clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615;     RN316) compared to placebo in subjects who are statin intolerant.   "
87939|NCT02135016|"     It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA     with different block level on propofol concentration during general anesthesia induction.   "
87940|NCT02135003|"     Hypothesis 1: The proportion of pre-ART patients whose CD4 cell counts decline to     ART-eligibility within 48 weeks will be lower in intervention compared to the     non-intervention arm.      Hypothesis 2: PLHIV who receive the PSCB intervention will experience lower rates of     morbidity or death over the follow-up period compared to patients not receiving the     intervention      Hypothesis 3: PLHIV who receive the PCSB intervention will have better adherence to scheduled     clinic appointments compared to those not receiving the intervention   "
87941|NCT02134990|"     The study will be a prospective open-label single-center study in previously treated patients     with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of     Oshadi D and Oshadi R with Docetaxel will be will be evaluated.      Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be     evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D     and Oshadi R.      CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3     Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be     considered or subsequent therapy.   "
87942|NCT02134977|"     The purpose of this survey is to examine the effect on quality of life (QOL) improvement and     convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection     kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a luteinizing     hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in premenopausal breast     cancer participants in daily medical practice. Influence of condition of estrogen receptor     expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit was     also evaluated.   "
87943|NCT02134964|"     This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy     volunteers after administration of single or multiple dose(s) of investigational drug     (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and     subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.   "
87947|NCT02134912|"     This randomized phase II trial studies how well pemetrexed disodium with or without     crizotinib works in treating patients with stage IV non-small cell lung cancer that has     progressed after crizotinib. Drugs used in chemotherapy, such as pemetrexed disodium, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Crizotinib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether giving pemetrexed disodium is more effective with or without crizotinib in treating     patients with non-small cell lung cancer that has progressed after crizotinib.   "
87948|NCT02134899|"     The investigators multicenter randomized open-labelled study will investigate the efficacy of     an everolimus based immunosuppression in reducing total native kidney volume in kidney     recipients with autosomal dominant polycystic kidney disease compared to a calcineurin     inhibitor-based immunosuppression.   "
87949|NCT02134886|"     This phase I trial studies the side effects and best dose of erlotinib hydrochloride in     treating non-small cell lung cancer that has spread to other parts of the body or cannot be     removed by surgery in patients with human immunodeficiency virus (HIV) infection. Erlotinib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Erlotinib hydrochloride is a standard drug used for treating lung cancer,     however, it is not yet known whether it is safe to give erlotinib hydrochloride to patients     who also have HIV infection or not.   "
87950|NCT02134873|"     Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures,     such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for     reducing pain during invasive procedures and is a standard of care for painful procedures.     The purpose of this study is to see what is the least amount of sucrose that can be given to     a baby to reduce pain during procedures.   "
87951|NCT02134860|"     Bed rest produces insulin resistance in healthy volunteers. In this study the investigators     aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate     daily fasting affects cognitive function and the insulin resistance produced by bed rest.      The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily     fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every     second (175% of daily calorie need).      The investigators hypothesize:        1. Bed rest reduces the incretin effect        2. Alternate daily fasting improves the cognitive function (memory and concentration)          compared to isocaloric diet        3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to          isocaloric diet   "
87952|NCT02134847|"     In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on     the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety;     and 2) the lack of data on the relationship between resident sleep deprivation and     preventable patient injuries. Through the Clinical and Translational Science Award     (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science     network in the U.S., we propose conducting a multi-center randomized crossover trial in six     pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious     errors (i.e., rates of harmful and other serious medical errors due to any cause, including     but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits)     of a sleep and circadian science-based (SCS) intervention schedule with a traditional     schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:        1. To test the hypothesis that PGY2&3 residents working on an SCS intervention schedule          will make significantly fewer harmful medical errors (preventable adverse events) and          other serious medical errors (near misses) while caring for ICU patients than residents          working on a traditional schedule; (primary endpoints: resident-related preventable          adverse events and near misses)        2. To test the hypothesis that rates of harmful medical errors (preventable adverse events)          and other serious medical errors (near misses) throughout the ICU (i.e., those involving          and those not involving residents) will be lower in ICUs when PGY2&3 residents work on          an SCS intervention schedule than when residents work on a traditional schedule; (major          secondary endpoints: ICU-wide preventable adverse events and near misses)        3. To test the hypothesis that resident physicians' risk of neurobehavioral performance          failures and motor vehicle crashes - as assessed through simple visual reaction time          tasks [Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses] - will          be lower on the SCS intervention schedule than on the traditional schedule. (major          secondary endpoints: resident neurobehavioral performance and predicted driving safety)   "
87953|NCT02134834|"     The objectives of this study are to assess the safety, tolerability and pharmacokinetic     profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at     single escalating doses.   "
87954|NCT02134821|"     Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.   "
87955|NCT02134808|"     The primary hypothesis is that compared to placebo, 10g of daily creatine monohydrate for     eight weeks will be associated with significant increases in frontal lobe phosphocreatine and     beta-nucleoside triphosphate (β-NTP) concentrations. A secondary hypothesis is that decreased     depressive symptoms measured with the Children's Depression Rating Scale-Revised (CDRS-R) and     Montgomery-Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with     increased β-NTP concentrations.   "
87956|NCT02134795|"     This is a single-center, unblinded trial without placebo control to evaluate the acute     effects of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease     patients.   "
87957|NCT02134782|"     Fatigue is a major problem in children, adolescents and adults receiving intensive     chemotherapy for cancer and in patients undergoing hematopoietic stem cell transplantation     (HSCT). Guidelines from the National Comprehensive Cancer Network suggest that all patients,     including children as young as 5 years of age, should be routinely screened for fatigue at     the initial visit and at regular intervals throughout and following anti-cancer treatment.     These guidelines also suggest that fatigue should be managed according to clinical practice     guidelines. However, evidence demonstrating effective interventions for fatigue in children     with cancer is scarce. Exercise is an effective intervention for cancer-related fatigue in     patients of all ages. However, patients receiving the most intensive treatments may be too     ill to participate in a standardized exercise program. A unique and potentially effective     intervention that combines exercise and relaxation is yoga. This randomized controlled trial     (RCT) will determine whether a 3 week program of individualized yoga is associated with less     fatigue, better quality of life (QoL) and less systemic opioid use compared to the control     program of an Apple tablet (iPad) games, music, movies or books. This is a single-site,     parallel-group, randomized trial of individualized yoga for fatigue. Subjects are inpatients     8-18 years of age receiving intensive chemotherapy for cancer or undergoing HSCT who are     expected to remain in hospital for 3 weeks. Participants will be randomized to the     individualized yoga program or to the iPad activity control program. For those who remain     hospitalized on day 21, the alternate intervention will be offered for 1 week and the     preferred strategy will be determined. Yoga has the potential to significantly reduce     fatigue, a prevalent and distressing symptom, in children with cancer and HSCT. The     investigators have assembled the optimal team with the expertise and track record to     accomplish this important trial. This trial is an incremental and critically important step     in a program of research designed to improve health for children at the highest risk for poor     quality of life. Results may have broad applicability to other hospitalized pediatric     populations and has the potential to change in-hospital care for these patients.   "
88063|NCT02133391|"     This study focuses on implementing and evaluating an evidence-based collaborative method of     increasing immunization rates among preschool children, adolescents and adults within an     Accountable Care Organization-Public Health collaborative. The infrastructure we will create     through this project will serve as the framework for future collaborative delivery of other     preventive services.   "
87960|NCT02134743|"     The aim of this study is to compare the stability of dental implant surface treated by     sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces     dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks     after installation. The evaluation will be made by analyzing the resonance frequency     (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show     increased secondary stability prior to the implants treated by acid etching.   "
87961|NCT02134730|"     Mental illness is a major health problem in children and young people, and there is evidence     that mental illness is increasing among young people in the population. More than 80 % of the     cost to society of mental illness in children in Sweden is the cost of treatment and care.      Anxiety and depression are the most common psychiatric problems in children and adolescents.      In comparison with the treatment of mental disorders, there is relatively limited knowledge     about prevention. There are at least two very important reasons to investigate further     preventive interventions for anxiety and depression. (1) Only about 20% of children and     adolescents with anxiety or depression use health services. (2) Some children stop treatment     and almost 40% do still fulfill criteria for the disorder after treatment.      FRIENDS for life is one of the most evaluated prevention programs internationally. The     program has shown promising results in research. The overall aim of the present study is to     evaluate FRIENDS for Life in Sweden.   "
87962|NCT02134717|"     The study hypothesizes that inhibition of the receptor CCR5 by maraviroc will diminish     inflammation in patients with sarcoidosis. Subjects with active sarcoidosis will first     undergo bronchoscopy with bronchoalveolar lavage to recover lung immune cells for baseline     analysis. They will then receive the drug maraviroc for 6 weeks duration. They will then     undergo a repeat bronchoscopy with bronchoalveolar lavage to recover lung immune cells for     analysis following maraviroc treatment.   "
87963|NCT02134704|"     The hypothesis of this study is that moderate scoliosis patients have postural and kinematic     differences (static and dynamic) compared with healthy volunteers and it is possible to     characterize and quantify.      The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis     patients compared with healthy volunteers   "
87964|NCT02134691|"     This project will examine the impact of PE therapy for the treatment of PTSD with a sample of     Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is     critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under     detected and under treated condition. Untreated PTSD has a substantial impact on health,     functioning and quality of life. PE is one of the most empirically supported psychological     interventions for PTSD. However, most studies that evidence the efficacy of PE have been     conducted mainly with English-speaking Caucasian populations. This study has the potential to     contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.   "
87965|NCT02134678|"     This study will compare mechanisms of action in two forms of brief psychotherapy for major     depressive disorder in adults. A treatment that targets deficits in motivation in depression     is expected to show greater improvements in motivation and pursuit of personal goals compared     to a second treatment that targets irrational thoughts that are typical in depression.   "
87966|NCT02134665|"     The purpose of this study was to evaluate the influence of severe acute pancreatitis on the     serum level of vancomycin, a glycopeptide antibacterial agent.   "
87967|NCT02134652|"     The purpose of this study is determine the ability of bedide ultrasound performed in the     Emergency Department and Outpatient Department can predict the severity of disease during a     Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the     presence of gallbladder wall thickening and/or pleural effusions in children correlates with     progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that     sonographic imaging of pediatric patients presenting to the emergency department with a fever     during a Dengue fever outbreak will change management and disposition.   "
87968|NCT02134639|"     Through the investigators involvement in an international consortium, the investigators had     the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers.     The investigators propose in this project to develop on their site, the radiosynthesis of     68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared     with the current imaging OctreoScan®. The objectives of this project are: - to validate the     radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically     evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with     68Ga-DOTATOC in comparison with other standard imaging examinations.   "
87969|NCT02134626|"     It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are     going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at     echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that     simvastatin can lower portal pressure.   "
87970|NCT02134613|"     Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is     effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory     articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the     joint or skin in these patients may help in guiding the course of treatment more efficiently.     The investigators research group has developed a novel approach to label anti-TNF-α with     technetium-99m. Here the investigators compare the results obtained with scintigraphy and MRI     in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α scintigraphy might recognize the     molecule involved in the inflammatory process and provide crucial information to help     physicians taking decisions about the drugs to be used based on biological evidence and which     are cost-effective and appropriate for the treatment of choice. It allows direct     identification of the monoclonal antibody anti-TNF-α in the articular joints and skin while     it also ensures that the drug has reached its therapeutic target. It also allows correlation     between the presence of the drug and clinical responses.   "
87971|NCT02134600|"     The purpose of this study is to find an optimal dose of omega-3 that can be given to children     who have completed cancer therapy. The future aim is to add omega-3 to conventional cancer     treatment modalities and thereby hopefully increase the treatment efficacy, which will have     to be addressed in subsequent phase-2 studies.   "
87972|NCT02134587|"     Spontaneous reports by health professionals generate the signals in pharmacovigilance.     However, the passive method has limitations and the most important of them are the     underreporting and the poor quality of data, hindering the causality assessment of adverse     drug events (ADE). Therefore, the present study aimed to validate an educational intervention     (EI) in pharmacovigilance for hospital health professionals, in order to analyze the impact     on the knowledge, skill and attitude in ADE reporting.      Investigators proposed a multifaceted EI which will be developed in four meetings with one     hour each. The following activities will be carried out: application of a questionnaire to     assess the knowledge, skill and attitude before and after EI; lecture; practical class and     education material distribution. The answers of questionnaire are going to be analyzed using     content analysis technique. The definitions of World Health Organization and the minimum and     desired criteria to fill the ADE form, according to the Pan American Health Organization, are     going to be considered gold-standard answers. The statistical test of Wilcoxon-Mann Whitney     test for paired samples will be applied, in order to assess the impact of educational     intervention on behavior of health professionals (ADE reporting).      With the present study, the following hypotheses will be tested:      H0= There is no difference between the numbers of ADE reported (behavior/attitudes) before     and after the educational intervention.      H1= The numbers of ADE reported before and after the educational intervention are different.   "
87973|NCT02134574|"     Prospective Cohort Study of clinical and laboratory data of patients with hemopathy.   "
87974|NCT02134561|"     The purpose of this study is to assess the psychological, cognitive and social resources of     applicants for Huntington's Disease and Presymptomatic Testing.   "
87975|NCT02134548|"     This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test     versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis.      The Chagas Detect™ Plus rapid test serves as an aid in the clinical laboratory diagnosis of     Chagas infection in patients. This test is intended to be used on human whole blood or serum     samples. Chagas Detect™ Plus results (positive or negative) must be confirmed by testing with     a reference standard test.      Subjects will be patients at clinical sites located in Chagas-endemic areas. After informed     consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be     collected. One is blood from finger prick, and the other is blood from venous puncture (drawn     from vein in arm).      Rapid tests and reference tests will be performed by different operators who are laboratory     staff members. These staff members, blinded to each other's results, will evaluate the     samples from each method independently.   "
87976|NCT02134535|"     The overall purpose of this research study is to collect vaginal and cervical biopsies from     healthy HIV negative participants. These samples will enable investigators to optimize     laboratory methods and explore implementation challenges associated with the ex vivo     challenge model. The first objective is to assess which HIV virus is best for use in the     model. The second objective is to determine the best endpoint for the assay.      The primary aim of this study is to collect an adequate number of cervical and vaginal     biopsies to support the optimization of an ex vivo challenge model. This ex vivo challenge     model has been and will continue to be used in topical microbicide clinical trials to predict     the efficacy of candidate drugs.   "
87977|NCT02134522|"     The purpose of this study is to examine whether CPAP therapy can reduce or eliminate hepatic     fat accumulation in obese children and adolescents.   "
87978|NCT02134509|"     The purpose of this study is to test the effectiveness of a smartphone application for     smoking cessation in smokers ages 18 to 65 years.   "
87979|NCT02134496|"     The study investigates the safety of discharge from the Post-Anesthesia Care Unit (PACU)     without assessment of motorfunction after spinal anesthesia for total hip- or knee     replacement. This is an randomized controlled trial between two groups with assessment of     normal (Aldrete) PACU discharge criteria with or without assessment of the motorfunction. The     study hypothesis is that it is safe to be discharged from the PACU to a ward without     assessment of motor function.      The main outcome is length of hospial stay (LOS) in days and re-admission within the first 30     days after surgery .      Secondary outcomes include adverse events up to 24 hours after surgery, and minuttes spent in     the PACU after surgery.      Participants will be monitores for adverse events for the first 24 hours after surgery and     reported. The total number of minuttes spent in the PACU will be recorded and reported.   "
87980|NCT02134483|"     Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of     permanent hypoparathyroidism. However, it is a difficult process that requires a number of     trained staff and advanced laboratory equipment which bring high costs. In this study, we     have identified a new PA-t technique.   "
87981|NCT02134470|"     It is generally accepted that chemical testing of biologic fluids is the most objective means     of diagnosis of drug use. In recent years saliva has attracted much attention. The prime     advantage of saliva is that it offers non-invasive, stress-free and real-time repeated     sampling whereas blood collection is undesirable, difficult and expensive. In addition, it is     known that androgens such as testosterone can be assayed in saliva, as these steroids pass     the endothelial-epithelial barriers by passive diffusion. Nevertheless, the correlations of     blood, urine and saliva concentrations are not well documented. In recent reviews, it is     pointed out that salivary hormone analysis could be a promising method for sports medicine     and doping control, but much work is needed before the use of saliva samples in this area     receives the acceptance. According to recent studies the increase of testosterone     concentration in saliva is significantly higher than alterations of steroid concentrations     (or ratios) in blood or urine. Saliva concentration may therefore serve as screening     parameter to select suspicious cases for further target evaluation (e.g. by IRMS). This may     be beneficial to identify cases of transdermal administration of low steroid doses. It is     therefore the aim of the present project to detect administered testosterone in saliva and     compare these levels to those in blood and urine. The intention is not to detect high dosage     but low dosage abuse of testosterone, as a single-dose by patch application. From the     practical point of view saliva could offer a complementary specimen for a pre-screening of     testosterone. So it could be assumed that salivary testosterone exceed upon plasma and/or     urine levels. So the present study could be the base for a new method to preselect the     suspicious samples for testosterone abuse.   "
87983|NCT02134444|"     Study Description and Purpose:      The vestibular sense organs of the inner ear consist of the semi-circular canals and otolith     end organs. These organs contain specialized gravito-inertial sensors that sense angular and     linear head acceleration. The input from these sensors is required to stabilize gaze position     during head motion, and provide an absolute frame of reference with respect to gravity, thus     providing a vertical spatial reference for body orientation and balance. Disease or damage of     the vestibular sense organs causes a range of distressing symptoms and functional problems     for people that could include loss of balance, gaze instability, disorientation and     dizziness. A novel computer based rehabilitation system with therapeutic gaming application     has been developed. This method allows different gaze and head movement exercises to be     coupled to a wide range of inexpensive, commercial computer games. It can be used in standing     and thus graded balance demands using a sponge pad can be incorporated into the program.      Study Objective:        1. Test the therapeutic effectiveness of the TRP delivered in the home compared to usual          care delivered in an out-patient physical therapy clinic on measures of balance          (standing and walking) , gaze control, dizziness, and health related quality of life in          individuals with peripheral vestibular disorders.        2. Compare trajectory of change in electronic gaze performance measures obtained during          each therapy session of each participant assigned to the home Telerehabilitation.      Hypothesis:      Investigators believe the Telerehabilitation platform to be a cost-effective delivery of     rehabilitation. Additionally motivation to perform tedious home programs can be improved with     engaging, fun and interactive computer gaming as part of the rehabilitation process. It is     hypothesized the home game-based Telerehabilitation program will result in greater     improvements in dynamic balance control, gaze control, and dizziness, in individuals with     peripheral vestibular disorders as compared to a typical out-patient physical therapy     regimen.   "
87984|NCT02134431|"     Microbicides are topical medicines that can prevent infection by Human Immunodeficiency Virus     (HIV). Microbicide medicine has yet to be studied in adolescents, a key group that is     becoming infected with HIV all over the world. From past research, we know that at different     ages people experience age-related changes in their bodies that can cause differences in how     they process medications. In this study, gut tissue samples (or gut biopsies) from 12     HIV-negative volunteers will be collected. These pieces of tissue will be infected with HIV     in the laboratory to develop a model that can be used to test certain drugs against the HIV     infection. We can use this tissue to test a drug called tenofovir against HIV infection. We     will determine whether this drug can decrease HIV infection in the gut biopsies. In this     study, we will also measure HIV levels and the levels of tenofovir in gut and blood samples     in 12 people who are already taking this drug. This information can determine whether levels     of drug found in the gut can protect it from HIV. The results can be compared to other age     groups of adolescents and adults. Subjects will undergo a common procedure called a lower     endoscopy (this can be a colonoscopy or a flexible sigmoidoscopy) to obtain gut biopsy     samples.      The central hypothesis is that tissue drug profiles of tenofovir (TFV) and its active     component, tenofovir disoproxil fumarate (TDF), and tissue infectibility vary between younger     (10-14 years old) versus older adolescents (18-21 years old), and that both differ from     adults (>21 years). Specifically, younger HIV positive adolescents will have lower levels of     tissue tenofovir compared to older HIV positive adolescents and adults in an age-dependent     manner. Additionally, biopsies from younger HIV negative adolescents will have: 1) higher     rates of infection compared to biopsies from older HIV negative adolescents infected with a     lower dose of virus; and 2) lower percent suppression of tissue infectivity compared to     biopsies from older HIV negative adolescents using low dose tenofovir.   "
87985|NCT02134418|"     Intervention aimed at improving understanding of irony in social situations by using movies     and comic strip will improve theory of mind.   "
87986|NCT02134405|"     This is a multi-Asian-centre randomised controlled trial of Rebamipide alone vs Rebamipide     with Esomeprazole in the treatment of adult patients with Functional Dyspepsia. The     hypothesis is that a combination therapy is superior to mono-therapy in the control of     patients' symptoms and quality of life improvement.   "
87987|NCT02134392|"     C-diff infection often causes belly pain and diarrhea and can be very hard to treat with     medicine. One of the possible reasons that C-diff infection is hard to treat is because there     is too much bad bacteria in the colon. Investigators believe that putting more good     bacteria into the colon will help fight the bad bacteria. We do this by doing a fecal     (poop) transplant.      Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital.     Since our Investigators have not done this before, this study will help us learn the best way     to do the transplant. Investigators also believe this transplant might help improve symptoms     for patients with C-diff.   "
87988|NCT02134379|"     This pilot study proposes to perform measurements of approved thoracic impedance technology     that will help answer questions in patients with decompensated heart failure.   "
87989|NCT02134366|"     The purpose of this study is to evaluate whether clobazam, brand name Onf®, is more effective     as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC) than either     lorazepam and/or clonazepam.   "
87990|NCT02134353|"     This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg     b.i.d. in subjects aged 18 years and above.      We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from     baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects     with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however,     this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample     size for statistical power while retaining trial feasibility in an orphan disease population   "
87991|NCT02134340|"     The purpose of the study is to evaluate the safety and biodistribution of [I-124]-CPD-1028     Injection in cancer patients with solid tumours.   "
87992|NCT02134327|"     Following an obtained written consent, a child presenting for ear tube surgery will be     randomized into one of three groups for receiving a premedication. One group will be the     current therapy with midazolam, another group will be another drug dexmedetomidine, and the     third group will be a combination of midazolam plus dexmedetomidine. Observers in the study     (the investigators fellow and advance practice nurse) will not know which group each patient     belongs, and will then make three separate assessments: preoperative sedation, mask     acceptance, and postoperative delirium.      Mask acceptance: Induction of anesthesia, or the beginning of the process for the patient to     fall asleep and lose consciousness, involves placing a mask over there face, specifically the     nose and mouth. The mask is connected to their anesthesia machine via tubing, or a circuit,     through which their anesthetic gases flow. Some children fight the mask as it can be seen as     new and frightening. Other children, sometimes depending on how sedated they are after     receiving a premedication, do not fear the mask on their face and do not resist induction.     How well or easily this happens can be described as mask acceptance. Postoperative delirium     can be seen in patients of any age or after any surgery and can be better defined as a mental     disturbance during the recovery from general anesthesia consisting of hallucinations,     delusions, and confusion manifested by moaning, restlessness, involuntary physical activity,     and thrashing about in bed. It has been considered a common postanesthetic problem in     children and adults since 1960.      Each patient will then have a set of numbers for each scale; following conclusion of the     study the investigators will be able see which drug each patient received and statistical     analysis can be completed. The investigators goal is to see if there is any difference in any     of the scales depending which medication was administered. The scales to be utilized include     the pre-operative sedation scale, the mask acceptance scale, and the pediatric emergence     delirium scale.   "
88688|NCT02125227|"     The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics     of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the     Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.   "
88104|NCT02132858|"     This research trial studies genetic mutations in blood and tissue samples to see if they can     be used to predict treatment response in patients with locally advanced rectal cancer     undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from     patients with cancer may help doctors learn more about genetic mutations or changes that     occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to     treatment.   "
87993|NCT02134314|"     The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with high     risk for delayed graft function (DGF) may show significant improvement in outcomes post     transplant compared with patients that do not receive C1INH treatment. Complement activation     has been detected in animal models and human kidneys with ischemic reperfusion injury (IRI)     and inflammatory cell infiltrates. By blocking complement activation the investigators hope     to improve kidney graft function post transplant in these recipients.   "
87994|NCT02134301|"     The purpose of this Phase 1 trial is to evaluate the PK, safety and tolerability of     oritavancin in patients <18 years old with a confirmed or suspected bacterial infection.   "
87995|NCT02134288|"     Currently looking for individuals that have received a kidney transplant, are experiencing     delayed graft function (DGF), and meet the criteria for study participation.   "
87996|NCT02134275|"     The purpose of this study is to evaluate the benefits and feasibility of a whole body     vibration (WBV) exercise program as a method of preventing weight gain in young adults.   "
87997|NCT02134262|"     The purpose of this study is to evaluate the safety, efficacy and blood kinetics of     autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor in     patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.   "
87998|NCT02134249|"     The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in the     prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent     intracytoplasmic sperm injection (ICSI).   "
87999|NCT02134223|"     Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with     considerable morbidity, mortality, and high rates of medical and psychiatric utilization     services. Research focusing on finding a biological observable marker for the purpose of     monitoring treatment effects has started to draw attention. Recent research has implicated     that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological     correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD     patients compared to general population, or pre- and post- psychotherapeutic treatment might     indicate the consequence of epigenetic modification associated with stressful experience or     suicide, and may later be able to explain the psychopathology or neuro-development of BPD.      Method: The investigators therefore propose this current randomized control trial to test     whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions     having suicide or non-suicidal self injurious behaviors will be followed and tested against     changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including     suicidality, depression, hopelessness, quality of life, disability, service utilization, and     function.      In the first to third years of this study, the investigators will aim to recruit 180 study     and control subjects, to gather information, to collect biological samples, to give out     one-year of psychotherapy per subject, to evaluate results before, during, and after     treatment. In addition, the investigators also hope to explore the effects of known or     unknown drugs associated with the change of DNA methylation at cell level.      Hypothesis:      Responders of participants who receive DBT will show greater decrease in BDNF methylation     levels than patients receiving TAU.   "
88000|NCT02134210|"     This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who     have not yet received any biologic therapy for any indication (other than insulin or     hormones).   "
88001|NCT02134197|"     The purpose of this study is to evaluate:        -  The side effects of BAY1129980 when given every 21 days different dose levels.        -  Determine the dose level of BAY1129980 that should be tested in future clinical research          studies.        -  Measure how much BAY1129980 is in the blood at specific times after administration.        -  If treatment with BAY1129980 shows any effect on reducing the tumor growth.        -  If there are specific biomarkers that might be able to explain why some patients respond          to treatment and others do not.        -  If treatment with BAY1129980 causes an immune response from the body against the drug          (immunogenicity).   "
88002|NCT02134184|"     In this study we are trying to understand whether previous infection with a particular virus,     namely cytomegalovirus (CMV), influences the ability of the immune system to respond to new     infections or vaccinations with age.   "
88003|NCT02134171|"     The aim of this study is to determine the frequency of cardiac and cerebral involvements in     patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be assessed     for cardiac involvement (troponin Ic level and cardiac ultrasonography) and cerebral     involvement (cerebral MRI). The investigators will assess whether serum troponin Ic on     diagnosis can predict morbidity and mortality of patients with a thrombotic microangiopathy     at the acute phase.      The primary outcome measurement is the event free survival at day 30, as defined by death,     myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An increase     in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among the three     daily analyses performed after TMA diagnosis.   "
88004|NCT02134158|"     The aim of this trial is to quantify the improvement of locomotion and equilibrium induced     par tDCS in anode polarity position in post stroke hemiplegic patients.   "
88005|NCT02134145|"     There is a great need within healthcare to develop systems of care that better engage and     activate people in their own care before they become patients. By so doing lay users will be     empowered to take charge of their own care in recognizing they can change their health and     improve their quality of life. Mobile health technologies such as the Scanadu ScoutTM hold     the potential to truly engage individuals in the way needed through real-time data capture,     transmission and connectivity.      We propose to evaluate the real-world use of the Scanadu ScoutTM by a cohort of self-selected     investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu Scout™, through a     prospective observational study. Using validated survey tools and through the remote tracking     of frequency of use and physiological measurements from the Scanadu Scout™ device and app.      Participants will receive web-based surveys at 4 time points: baseline, 3, 12 and 18 months.      Participants will be instructed to use the Scanadu Scout™ as much as they would like. The     parameters that will be functional on the device and available for measurement by the     participant are:        -  Heart rate        -  Respiratory rate        -  Temperature        -  Oxygen saturation        -  Heart rate variability        -  Blood pressure      Data analysis will examine individual participant and aggregate level:        1. Usage and physiologic measurement data of the device,        2. Perceptions of the device, and        3. Changes in self-reported health self-management, health-related quality of life,          participant- physician communication and medication adherence between baseline and          follow-up.   "
88816|NCT02123524|"     This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre     trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg     Superficial Vein Thrombosis (> or = 5cm) that otherwise would not initially be treated with     anticoagulant therapy.   "
88006|NCT02134132|"     Diabetes is a multiorgan disease and considered a major health problem in different     societies. One of the complications the pain particularly in the extremities resulting from a     process known as diabetic foot ulcer. The diabetic patients are subjected to many     complications because of foot ulcers, many of them like as chronic wound disease or pressure     ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to     nursing care and take too long until pain relief. Among many tested materials and works for     wound healing such as debridement, tissue oxygenation, and skin transplantation,     platelet-derived compounds are allocated the pivotal position between investigators to tissue     regeneration and shortening the wound healing process.      Many of platelet components are procured from platelet rich plasma (PRP) from whole blood     donation. Furthermore, it requires to an additional purification step to diminish the volume     and facilitate handling in some studies. It means that platelet concentrates (PCs) may be     obtained leading to more concentrated platelets in lower volume.      Two types of granules in platelet is responsible for storage of many useful and different     growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the     ability to growth and differentiation of numerous cells. Also, the antibacterial effect of     these growth factors has been reported.      To better efficacy and comfortable utilization of platelet, it is feasible to form the     platelet gel and then apply on wound sites.      This study is a double blind randomized controlled trial to evaluate the positive effects of     umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.   "
88007|NCT02134119|"     The purpose of this study was three-fold. We wanted to (1) determine if supplementation with     an echinacea-based dietary supplement (ECH) would increase several blood parameters that     could affect oxygen carrying capacity in the body, (2) determine if ECH would increase VO2max     in trained endurance athletes, and (3) examine the effectiveness of two different doses of     the ECH on all outcome variables. We hypothesized that supplementation with ECH would     increase oxygen carrying capacity (as measured by RBCs, EPO, ferritin, hemoglobin (Hb), and     hematocrit (Hct) levels), improve VO2max, and that the maximum dose would be most effective     at increasing these outcomes.   "
88008|NCT02134106|"     Background and rationale:      Antimicrobial resistance is a global public health threat. An increasing number of     Gram-negative bacteria isolates worldwide are resistant to virtually all antibiotics     including carbapenems. Although polymyxins are the current gold standard antibiotic for     treatment of severe extensively drug-resistant Gram-negative bacteria (XDR-GNB - defined in     Appendix I) infections, resistance development on therapy and treatment failures are common.     Combination antibiotics therapy have better in vitro efficacy, but have not been formally     tested in a prospective trial.      We will conduct a Phase IIB, prospective, open-label, randomized-controlled trial in 4 major     Singaporean hospitals, with balanced treatment assignments achieved by permuted block     randomization, stratified by hospital. There will be 75 subjects per arm, with the subjects     in the comparator arm receiving standard-dose polymyxin B while the intervention arm will     receive a second antibiotic, doripenem, with polymyxin B against the bacterial isolate in     question. Subjects with ventilator-associated pneumonia (VAP) will additionally receive     nebulized colistin. The primary outcome is 30-day mortality while secondary outcomes include     microbiological clearance, time to defervescence, and toxicity of therapy, presence of     secondary infections due to new multi-drug resistant bacteria and length of ICU stay. Plasma     drug levels will be measured by liquid chromatography-mass spectrometry.      Hypothesis:      The underlying primary hypothesis is that combination antibiotic therapy (IV polymyxin B + IV     doripenem) is superior to mono-antibiotics therapy (IV polymyxin B) in reducing 30-day     mortality from XDR-GNB infections.   "
88009|NCT02134093|"     This study is to explore the effects of dexmedetomidine on postoperative cognitive     dysfunction during one-lung ventilation in elder patients.   "
88010|NCT02134080|"     The purpose of this trial is to examine the safety, tolerability and feasibility in the use     of a FAAH inhibitor for the treatment of adults with Tourette syndrome.   "
88011|NCT02134067|"     The purpose of this study is to determine the safety of TAS-119 and determine the most     appropriate dose in combination with Paclitaxel for subsequent studies in patients with     advanced solid tumors.      TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been     demonstrated to enhance the activity of paclitaxel in preclinical studies   "
88012|NCT02134054|"     In this cross sectional and longitudinal study, patients with inflammatory bowel disease on     biological treatment with infliximab or adalimumab will be included.      After inclusion, the dosage of their existing biological therapy will be adjusted following     regular trough-level and antibody-level monitoring, according to a treatment algorithm.      Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis     is that therapeutic drug monitoring may improve clinical disease outcome after one year of     follow-up.   "
88013|NCT02134041|"     We are extending the researches of Taiwan neurosurgery traumatic brain injury (TBI) database     which is led by Professor WT Chiu in Taipei Medical University and will recruit mild TBI     (mTBI) participants who have ever been registered in the database. This database has been     established for over 15 years and contains the information of over 150000 patients. It is one     of the largest TBI database in the world.      TBI usually results from traffic accidents, falls or violence events. Most of the victims are     young people and the victims suffer from life-threatening and mental-physical deficits. Mild     TBI (mTBI) usually was neglected before because its symptoms, signs are mild and mTBI     patients usually were not obtained enough initial treatment. Therefore, mTBI might result in     long-term cognitive and affective impairments, such as depression, indifference, anxiety,     memory impairment, loss of attention and executive function. These late effects not only     decrease the life quality of patients and their family but also increase the social and     medical burden.      Recent epidemiology studies have pointed out that TBI would increase the risk for dementia,     especially Alzheimer disease (AD) by 2-4 times. However, the association between TBI     severity, number of repeats, genetic factors and onset of AD remains further investigation.      Amyloid-β (Aβ) plaques and neurofibrillary tangles are the pathological hallmarks for AD.     Accumulation of Aβ is considered to be the first step of pathophysilogy of AD. Compelling     researches have supported TBI accelerates the formation and accumulation of Aβ. These     findings could link TBI with AD but the previous researches had limitations. There was lack     of mTBI pathology data so the impacts of mTBI on Aβ accumulation were still obscure. By     amyloid-PET, we could study the effects of mTBI on the accumulation of Aβ and this tool could     be helpful for understanding the real impacts and pathophysiological mechanisms of mTBI on     AD.   "
88103|NCT02132871|"     The primary purpose of this study is to investigate wether the measure of stroke volume (SV)     variations by impedance cardiography during passive leg raising (PLR) can reliably predict     preload dependency after cardiac surgery, in comparison to a reference parameter : velocity     time integral (VTI) variation measured by transthoracical echocardiography.   "
88014|NCT02134028|"     Primary Objective:      Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who     participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).      Secondary Objectives:      Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous     dupilumab asthma clinical study.      Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma     clinical study, with regards to:        -  Systemic exposure        -  Anti-drug antibodies        -  Biomarkers   "
88015|NCT02134015|"     1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free          survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor          Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer          progressed after at least one prior systemic anti-cancer therapy, available recent or          archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2          (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects          may have high heregulin or low heregulin.        2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival          will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance          or metastatic NSCLC and have their cancer progressed after at least one prior systemic          anti-cancer therapy, available recent or archival tumor specimen and may not have had          previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only          subjects with high heregulin will be enrolled.   "
88016|NCT02134002|"     This study represents a randomized, double blind placebo-controlled trial. Thirty cocaine     dependant patients will be included in this study during their hospitalization for     withdrawal. After the inclusion visit, they will be randomized to receive disulfiram 250     mg/day or placebo over the 15 days of their hospitalization. Main outcome criteria will be     evaluated during two TEP imaging sessions with 11Craclopride, before and after stimulation by     methylphenidate, 8 to 15 days after randomization.   "
88017|NCT02133989|"     The purpose of this study is to evaluate the efficacy and safety of the ticlopidine + ginko     biloba compared to clopidogrel in clopidogrel resistant patients undergoing carotid artery     stent placement. The investigators hypothesized that ticlopidine + ginko biloba is superior     than clopidogrel in terms of post-stent ischemic lesions in these patients without serious     complications.   "
88018|NCT02133976|"     Psychosocial interventions are attractive options for treating chronic low back pain, and     many approaches now have strong support for efficacy. However, few empirical data address     whether psychosocial pain treatments work because of mechanisms specified by theory, and thus     investigators know very little about HOW our treatments work. It may be that different     treatments work via distinct pathways that are specific to a given treatment (single effect     model), or it may be that different treatments work to the extent they all operate via key     mechanisms that they share (additive effects model). Examination of specific and/or shared     effects on outcomes of mechanisms will provide theoretical and empirical rationale for     enhancing procedures and techniques most closely linked to strong outcomes and incorporating     them into future interventions, while limiting the use of others that may be revealed as     inert.   "
88019|NCT02133963|"     Psychosocial factors, including a previous history of depression, recent stressful life     events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy     have been shown to be associated with an increased risk for the development of postpartum     depression (PPD). Biological mechanisms underlying the relationships among these psychosocial     risk factors for PPD, and the development of PPD, remain unclear. However, evidence from     non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine     factors may play a role. The primary objectives of this study are: (1) to assess the     feasibility of enrolling second trimester pregnant women, with or without depression     histories, into a laboratory-based study protocol which includes a mild psychosocial stressor     and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic     hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a     brief postpartum phone interview, after completion of the second trimester assessments; and     (3) to establish proof of concept for measuring group differences, between women with or     without depression histories, in second trimester prenatal measures of neuroendocrine stress     reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.   "
88020|NCT02133950|"     A single centre observational study into the segmentation of preimplantation genetic     diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation     of all genetically transferable embryos after PGD, compared to fresh embryo transfer     cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of     the study is to assess the feasibility and effectiveness of segmentation in terms of     pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD     cycles.      Experimental questions        1. Is the cumulative live birth rate rate of a single PGD treatment when all genetically          transferable embryos are cryopreserved by vitrification prior to consecutive in utero          transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer          cumulative with transfer of supernumerary cryopreserved embryos?        2. Does the technique of segmentation allow better planning of DNA amplification and          genetic analysis?      Design The proposed design is a pragmatic, prospective randomised controlled trial   "
88021|NCT02133937|"     This single-center, randomized open-label, single-dose, parallel group study will investigate     the relative bioavailability of a high concentration liquid formulation (HCLF) versus the     reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be     randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.   "
88075|NCT02133235|"     The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial     blockers (EBB) have been presented effective and safe alternative for lung separation in     vedio-assisted thoracoscopic (VATS) operations. In this study, the investigators will     randomize the patients receiving VATS operation with EBB into two groups: one group will     receive the conventional bronchoscopic guided EBBs placement, the other group receive two     step procedure without confirmation by fiberoptic bronchoscopy.   "
88141|NCT02132364|"     The main objective of the study is to compare the benefit of optimised follow-up by nursing     personnel from the vascular neurology department, including therapeutic follow-up and an     educational program directed to the patient and a caregiving member of his social circle,     with that of a typical follow-up.   "
88022|NCT02133924|"     This research trial is designed to study the safety and effectiveness of combining the study     drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new     treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious     complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft),     treat the recipient's body as foreign and attack the cells in the recipient's body. During     this immune system response, donor cells damage body tissues, such as the skin, liver,     stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the     transplant recipient. Acute GVHD usually happens within the first several months after     transplant.      The goal of this research is to develop a safer and more effective treatment for acute GVHD,     and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the     ultimate goal being safer and more effective transplant therapies for blood cancers such as     leukemia, lymphoma, and multiple myeloma.   "
88023|NCT02133911|"     Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients     with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave     symptoms of angina in patients with stable coronary disease that is not suitable for surgical     or percutaneous revascularization. It has been shown that in patients with stable coronary     disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging.     The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in     patients with dilated cardiomyopathy.   "
88024|NCT02133898|"     This is an open-label study assessing the efficacy of l-methylfolate as monotherapy in     patients with mild to moderate major depressive disorder (MDD). The plan is to enroll 75     patients with mild to moderate MDD based on the Structured Clinical Interview for DSM-IV     (SCID) that have a Hamilton Depression Rating Scale-24 (HDRS-24) score between 8-24. The     investigators will collect genotype data on methylenetetrahydrofolate Reductase (MTHFR), MTR     and MTRR in this patient population. Subjects will be able to receive their genotype results,     on request, upon completion of the study. The investigators hypothesize that depressed     patients will be more likely to have a mutation in the MTHFR gene   "
88025|NCT02133885|"     Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease,     diabetes, obesity and metabolic syndrome. Despite advances in life style modification and     multi-drug therapies, 20-30% of all hypertensive patients remain resistant.      These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and     norepinephrine spillover, and low parasympathetic activity. It is generally accepted that     this uncontrolled, resistant HTN is primarily neurogenic in origin, involving over activity     of the sympathetic nervous system that initiates and sustains HTN. Thus, a mechanism-based     breakthrough is imperative to develop novel strategies to prevent and perhaps eventually cure     neurogenic hypertension (NH).      This study is a double-blind, placebo-controlled, cross-over design to test the hypothesis     that minocycline treatment would produce antihypertensive effects in drug-resistant     neurogenic hypertensive individuals.   "
88026|NCT02133872|"     Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease,     diabetes, obesity and metabolic syndrome. Recent American Heart Association (AHA) statistics     indicate that one-third of all adults in the United States of America suffer from HTN.     Despite advances in life style modification and multi-drug therapies, 20-30% of all     hypertensive patients remain resistant.      These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and     norepinephrine spillover, and low parasympathetic activity. It is generally accepted that     this uncontrolled, resistant HTN is primarily neurogenic in origin, involving over activity     of the sympathetic nervous system that initiates and sustains HTN. A surgical approach such     as the recently developed Simplicity Catheter assisted renal denervation remains one of the     few options available to these patients. Thus, a mechanism-based breakthrough is imperative     to develop novel strategies to prevent and perhaps eventually cure neurogenic hypertension     (NH). This study is designed to evaluate a low and high dose of minocycline to test the     hypothesis that minocycline treatment would produce antihypertensive effects in     drug-resistant neurogenic hypertensive individuals. Minocycline has been selected because of     its demonstrated effects on inhibiting microglial activation and its ability to penetrate the     blood brain barrier. There is no other compound available that is safer and displays     specificity better than Minocycline in inhibiting microglial activation. Thus, the potential     therapeutic benefits of this inexpensive, well tolerated, already FDA-approved drug that has     minimal side effects would be enormous.   "
88027|NCT02133859|"     Sleep disordered breathing is very common in patients with chronic heart failure with     reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat     sleep apnea in these patients. This is an observational study to document changes in     respiratory parameters in HF patients using ASV for a period of 12 months.   "
88028|NCT02133846|"     The purpose of this study is to determine the safety and tolerability [maximum tolerated dose     (MTD) within planned dosing range] of intravenous (IV) infusions of TPI 287 administered once     every 3 weeks for 9 weeks (for a total of 4 infusions) in patients with primary four repeat     tauopathies (4RT), corticobasal syndrome (CBS; also called corticobasal degeneration, CBD) or     progressive supranuclear palsy (PSP).   "
88029|NCT02133833|"     This is a prospective, self-controlled study to evaluate the efficacy of the Quantum spectrum     radiation emitter for adhesive capsulitis.   "
88030|NCT02133820|"     To assess whether an opioid antagonist has any impact on the release of a strong painkiller     in the blood when it is given to healthy volunteers when they have eaten and also when they     have fasted.   "
88031|NCT02133807|"     To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy     could affect atherosclerotic disease burden in coronary and carotid arteries of coronary     heart disease patients with elevated Lp(a) levels.   "
88032|NCT02133794|"     The purpose of this project is to determine if using tomosynthesis, in conjunction with     x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study     will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes     to the emergency room with symptoms of a hip fracture.   "
88033|NCT02133781|"     This is an exploratory study using a strategy that has not been previously employed to     investigate the effects of age and vaccine type on specific kinds of immune responses to     licensed, seasonal 2009-2010 influenza vaccines in children and adults.   "
88035|NCT02133755|"     The primary aim of this study is to determine the effect of dopamine agonist therapy on     insulin resistance in lean vs. obese women with polycystic ovary syndrome. Polycystic ovary     syndrome (PCOS) is a common metabolic abnormality in women. The diagnosis of PCOS relies on a     constellation of symptoms and signs (problems with ovulation, clinical and/or biochemical     signs of hyperandrogenism and cystic ovaries). Though not a diagnostic feature, insulin     resistance (IR) is a hallmark of PCOS and up to 80% women with PCOS have IR. Although IR is     more significant in obese women with PCOS, even lean women can be insulin resistant. No     current therapy addresses the problem of insulin resistance in PCOS. Studies have suggested a     dopamine deficiency in patients with PCOS, which may underlie the insulin resistance and may     have a pathogenetic role in the development of PCOS. No study to date has assessed the impact     of dopamine agonist therapy on IR in patients with PCOS.   "
88036|NCT02133742|"     Despite substantial improvements of patients outcome in advanced RCC, durable and complete     response is uncommon. The majority of patients eventually develop resistance and exhibit     disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with     axitinib may provide additional clinical benefit compared to axitinib alone.   "
88037|NCT02133729|"     Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This     complication occurs in 4-10% and is associated with fetal complications and macrosomia. In     addition, women with GDM have an increased risk to develop type 2 diabetes after delivery.     Despite recommendations, it is difficult to follow-up all women with GDM during the     postpartum period due to high numbers of subjects that exceed usual healthcare resources. It     is therefore necessary to focus clinical attention toward women at high risk of type 2     diabetes in order to set adequate preventive strategies.   "
88038|NCT02133716|"     The aim of this study is to assess the non-inferiority of non- pharmacological breast milk     expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.      This is an experimental comparative study of non-inferiority randomized crossover, to be     performed in Neonatal units of hospitals in the Community of Madrid.      The 54 pair of preterm that after the selection criteria are included in the study, they     performed the randomization of the sequence and breast milk expressed receive oral or 24%     sucrose.      The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA),     0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups     will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior     to venipuncture.      The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile     (PIPP) and by percent of cry.      Data for the primary objective was analysed per intention to treat. This study was approved     by local ethical committee.   "
88039|NCT02133703|"     This non-therapeutic trial is for women who have received results of genetic testing for     BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed     decision making regarding risk management following testing to usual care. The researchers     will test separate decision support tools for women who receive positive test results and     women who receive negative/inconclusive test results. Among women who receive a positive test     result, an interactive decision support intervention will be compared to a print     intervention. Among women who receive an inconclusive result, an interactive intervention     will be compared to usual care.   "
88040|NCT02133690|"     This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to     determine the effectiveness of the rotavirus vaccine.   "
88041|NCT02133677|"     Brain metastasis (BM) is among the most feared complications in cancer because even small     tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of     patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ)     is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to     evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus     concomitant TMZ in lung cancer and breast cancer patients with BM.   "
88042|NCT02133664|"     The primary aim is to collect data to determine the correct effect size on the primary     outcome to aid in the design of a larger study: The primary outcome is to determine if lipoic     acid and omega-3 fatty acids can improve cognitive function in people with multiple sclerosis     that have cognitive dysfunction.   "
88043|NCT02133651|"     Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea.     Treatment of this infection usually occurs using other antibiotics, but many individuals have     persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal Microbiota     Transplantation, (IMT) has been shown to be efficacious when administered after treatment for     C. difficile. This study will involve taking biopsies from patients during their FMT/IMT via     colonoscopy, and determine if there are differences in the mucosal flora as compared to the     stool flora. The investigators hope to discover the critical parts of a healthy microbiota.   "
88044|NCT02133638|"     The aim of this study is to distinguish possible differences in frequency of delirium after     Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of     undeliberate cerebral desaturation during non-cardiac surgery.   "
88045|NCT02133625|"     The proposed investigation is a Phase 1 trial to determine the safety, tolerability, and     maximum tolerated dose (MTD) of the combination of pioglitazone ( and carboplatin patients     with advanced or metastatic solid malignancies.   "
88046|NCT02133612|"     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.        -  Five year survival rate after radical esophagectomy is modest at about 40%.The patients          with regional lymph node metastases have worse outcome than those without lymph node          metastases.        -  No standard postoperative adjuvant chemotherapy has ever been established.   "
88090|NCT02133040|"     The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in     humans in an observational study on patients with thyrotoxicosis. In the investigators     evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in     the acute phase of the disease and in the euthyroid phase after treatment.      It is the investigators hypothesis that high levels of circulating T3 might affect amount and     function of brown adipose tissue.   "
91363|NCT02090218|"     The main objective of this trial is to compare the effectiveness of a newer supraglottic     airway method (the i-Gel), compared to current airway management practice in out-of-hospital     cardiac arrests treated by Norwegian ambulance services.   "
88047|NCT02133599|"     Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed     with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States. (For     the purposes of this protocol, ALL will be used to refer to patients with either acute     lymphoblastic leukemia or acute lymphoblastic lymphoma as patients are treated in the same     manner.) High-dose methotrexate (HDMTX; 5 g/m2) remains an important component of standard     treatment for most ALL patients. However, high plasma and intracellular MTX concentrations     (defined as a MTX level of >1 µmol/L at 42 hours and > 0.40 µmol/L at 48 hours) can quickly     lead to acute kidney, bone marrow, liver, skin, central nervous system, and gastrointestinal     toxicities requiring extended hospitalization and delays in subsequent chemotherapy     treatments.      This study seeks to identify more sensitive markers of kidney injury that could serve as     better predictors of delayed excretion and/or toxicity of HDMTX. This study is a pilot     repeated-measures feasibility study.      Hypothesis 1: Directly measured GFR (mGFR, a type of test to measure the filtering rate of     kidneys) by iohexol clearance obtained prior to HDMTX will demonstrate greater sensitivity     and specificity for prediction of delayed MTX excretion and/or toxicity in children and     adolescents with ALL than serum creatinine (sCr) alone or sCr used for eGFR calculation. If     this study proves that mGFR is a better predictor of delayed MTX excretion and/or toxicity,     then another study will be developed in the future to determine if modifying the HDMTX dose     or adjusting supportive care based on mGFR will prevent delayed clearance and toxicity     without impacting patient survival.      Hypothesis 2: Those participants prospectively demonstrating delayed MTX excretion or     toxicity will exhibit elevation of kidney injury biomarkers less than 24 hours following     initiation of HDMTX infusion compared to pre-chemotherapy measurements. These biomarkers will     increase prior to a measurable sCr elevation.   "
88048|NCT02133586|"     The U.S. Environmental Protection Agency has traditionally examined the effects of single     pollutant exposure on human health outcomes; however, to provide a better assessment of     pollutant exposure-associated effect on human health the Agency is moving toward a     multi-pollutant approach. Ozone (O3) and nitrogen dioxide (NO2) are national ambient air     quality standards (NAAQS) criteria pollutants that are major constituents of ambient air     pollution. This study will address the Agency's goals by investigating the cardiopulmonary     health effects of sequential exposure to O3 and NO2 in healthy adult human volunteers. The     findings of this study will provide data that will inform risk assessment models for O3 and     NO2 exposures. Additionally, the findings will provide insight into how the human health     effects of multi-pollutant exposures differ from those of single pollutant exposures.   "
88049|NCT02133573|"     Neurodevelopmental disability is now recognized as the most common long-term complication     after cardiac surgery in neonates. Research studies have shown that progesterone is critical     to the development of the brain and in a variety of clinical situations including brain     injury can protect the brain.      The purpose of this research study is to determine whether progesterone administered during     the 3rd trimester of pregnancy (24-39 weeks) to pregnant women protects the brain of unborn     babies with CHD and improves their neurodevelopmental outcomes after heart surgery.   "
88050|NCT02133560|"     Purpose: Assess whether intensive training with education and daily remote monitoring with     provider involvement has a lasting positive impact on adherence to medication management. The     study will seek to enroll 25 subjects with sickle cell disease or thalassemia, and less than     100% compliance for taking iron chelators in the previous three month prior to participation     in the study. Subjects will be asked to monitor their daily iron chelator administration by     taking a video recording of preparing it and ingesting at least one sip. Subjects will also     use a medication log to record daily administration of medication, and meet with study staff     monthly for educational activities. The data collected will be analyzed to describe patient     adherence and comfort level with the process of daily recording of medication management.     Mean percent adherence in the pre-study periods and each of the study periods will be     analyzed and compared.   "
88051|NCT02133547|"     Primary ciliary dyskinesia (PCD) is a rare genetic disorder characterized by impaired airway     mucociliary clearance leading to recurrent respiratory infections, bronchiectasis and     eventually respiratory insufficiency. Diagnosis of PCD is difficult and relies on complex     methods which are not widely available (1).      Nasal nitric oxide (nNO) is reduced in PCD patients as compared to normal subjects, and nNO     measurement has been proposed as a non-invasive screening tool for PCD. However, nNO     measurement techniques are not standardized and reference values are lacking (2, 3).      The NIOX MINO is a handheld analyzer developed for the non-invasive measurement of exhaled NO     (eNO) in asthmatics. Measurement of nNO with the NIOX MINO has been reported in only few     studies (4-6), which mainly compared the NIOX MINO with others NO analyzers. However, no     study attempted to establish reference values with the NIOX MINO in a large number of normal     subjects.      One critical issue in nNO measurement is to avoid contamination of nasal air by exhaled     alveolar air during nNO sampling. This can be obtained by either breath holding, or by a     breathing technique allowing soft palate closure during sampling, such as mouth breathing     again resistance. However, as sampling times with the NIOX MINO are long (2 minutes at a flow     of 2 ml/min, and 45 seconds at a flow of 5 ml/min), these techniques may be difficult to     apply.      In this pilot study, we will determine normal nNO values in 100 healthy men and women aged 20     to 70 years using 3 different breathing techniques:        1. breath holding during 45 seconds        2. mouth breathing through a fixed resistance (a straw), to create a small positive          pressure in the oropharynx during expiration only        3. mouth breathing through a continuous positive airway pressure (CPAP) apparatus, which          produces continuous soft palate closure during quiet spontaneous breathing, thus          allowing long sampling times for nNO measurement.      This study will allow: 1) to determine whether nNO can be reliably measured with the NIOX     MINO in adult normal subjects, 2) to identify the most reproducible breathing technique, 3)     to determine normal values of nNO as measured by the NIOX MINO, and 4) to explore possible     differences between genders and age groups.      References:        1. J.S.A. Lucas, W.T. Walker, C.E. Kuehni and R. Lazor. Primary ciliary dyskinesia. Eur          Respir Mon. 2011; 54: 201-217.        2. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline          Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am J          Respir Crit Care Med 2005; 171: 912‑30.        3. Marthin JK, Nielsen KG. Choice of nasal nitric oxide technique as first-line test for          primary ciliary dyskinesia. Eur Respir J 2011; 37: 559‑65.        4. Marthin JK, Nielsen KG. Hand-Held Tidal Breathing Nasal Nitric Oxide Measurement - A          Promising Targeted Case-Finding Tool for the Diagnosis of Primary Ciliary Dyskinesia.          PLoS ONE 2013; 8: e57262.        5. Weschta M, Deutschle T, Riechelmann H. Nasal fractional exhaled nitric oxide analysis          with a novel hand-held device. Rhinology 2008; 46: 23‑7.        6. Maniscalco M, Laurentiis G de, Weitzberg E, Lundberg JO, Sofia M. Validation study of          nasal nitric oxide measurements using a hand-held electrochemical analyser. Eur J Clin          Invest 2008; 38: 197‑200.   "
88052|NCT02133534|"     The purpose of this study is to see if patients with chronic kidney disease have endothelial     cells that don't function properly, which is thought to be a marker for cardiovascular risk.     Endothelial cells line the heart and blood vessels. The investigators will treat your high     cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine     if this cholesterol lowering drug improves subjects' cholesterol as well as the function of     endothelial cells.   "
88053|NCT02133521|"     This is a prospective, randomized, double-blind, and controlled clinical study to investigate     the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy     alone in acute ischemic stroke patients. It is hypothesized that the improvement in     functional outcomes as measured by NIHSS and BI as well as the improvement in haemostatic     parameters as measured by thrombocyte aggregation test (TAT), fibrinogen, and d-dimer in DLBS     group will be significantly greater than those in the control group.   "
88054|NCT02133508|"     This multicenter, retrospective and prospective observational, cohort study will examine the     effect of second-line Tarceva treatment on long response in NSCLC patients with wild type or     unknown EGFR status. Patients will be observed from the start of treatment for 8 months or     until death. The extension of the retrospective versus prospective observation will depend on     the lag between the date of the patient enrollment and the date of beginning of erlotinib     therapy.   "
88055|NCT02133495|"     The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived,     non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the     correction of lower eyelid retraction, taking into consideration issues associated with the     use of acelular dermis such as contraction and potential regression of repairs.   "
88056|NCT02133482|"     The primary objective of this trial is to investigate the safety and tolerability of BI     639667 in healthy male subjects following oral administration of single rising doses.      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose     proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667     after single dosing and the assessment of the PK/PD relationship.   "
88057|NCT02133469|"     A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7     and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the     prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C,     19F, and 23F combined) in 2 to 5 years old healthy Chinese children.   "
88058|NCT02133456|"     To monitor the safety of Shanghai Institute of Biological Products Company's influenza     vaccine in subjects aged 3 years and older through Adverse Events Following Immunization     Surveillance System of China.      The hypothesis is that there is no significant difference in the occurrence of adverse events     among influenza vaccines manufactured by SIBP and other companies.   "
94191|NCT02053207|"     The purpose of this study is to evaluate the feasibility of administering a 20-day     preoperative cognitive training intervention (Cog-Train) to a widely inclusive sample of     cardiac surgical patients.   "
88064|NCT02133378|"     A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix,     coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to     be extremely effective, in addition to traditional means, in terminating bleeding during     cardiac operations with control rates as high as 97,5%. The investigators compared such     hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis     routine.      Following sample size calculation, in a prospective randomized study design, 100 patients     will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis     routine (comparison group).      To make the two cohorts as comparable as possible enrollment will be restricted to moderately     bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding     transversal aortotomy.      Study endpoints are the following: rate of successful intraoperative hemostasis (identified     by cessation of bleeding in less than 3 minutes from application) and time required for     hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of     surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.   "
88065|NCT02133365|"     This is an investigation of a mindfulness and interoceptive exposure intervention in patients     with atrial fibrillation, to decrease anxiety sensitivity, symptom burden, and atrial     fibrillation recurrence.   "
88066|NCT02133352|"     This is a single center, open-label trial designed to assess the safety and efficacy of     ranolazine (Ranexa) in patients with pulmonary hypertension associated with left ventricular     diastolic dysfunction. All patients will receive active drug. The study includes a screening     period, 6 month treatment period and a follow up period. Eligible patients who provide     informed consent and who meet all inclusion/exclusion criteria will be enrolled in this     study.      There is neither proven therapy for patients with diastolic dysfunction-associated pulmonary     hypertension nor for patients with diastolic dysfunction alone. Ranolazine, an inhibitor of     cardiac repolarization (sodium channels), could represent a new and effective treatment of     this entity.   "
88067|NCT02133339|"     This single ascending dose study is to determine and evaluate the safety and tolerability of     TRN-157 in approximately 40 healthy subjects.   "
88068|NCT02133326|"     This study will compare how effective a single dose of an intravenous (IV) ibuprofen is when     compared to single dose of IV acetaminophen in reducing pain. We will administer this study     medication thirty minutes prior to removal of wisdom teeth. We want to see if administering     these drugs prior to surgery may reduce post-operative pain.      Administration of nonsteroidal anti-inflammatory drug before the onset of inflammation during     surgery will reduce postoperative pain following third molar extraction when compared to the     acetaminophen group. Subjects receiving nonsteroidal anti-inflammatory drug will consume less     opioid medications compared to those receiving preemptive acetaminophen.   "
88069|NCT02133313|"     The time on peritoneal dialysis may be limited for a significant number of patients that use     this modality of renal replacement therapy due to the inability of the peritoneal membrane to     clear solutes or achieve adequate ultrafiltration, termed peritoneal membrane failure (PMF).     This can be devastating for patients who have become accustomed to the quality of life     provided by peritoneal dialysis and who otherwise have done well on this therapy. There is     clinical evidence suggesting that icodextrin preserves the peritoneal membrane transport     characteristics which may be linked to reduced cumulative glucose exposure of the peritoneal     mesothelial cells. Theories to explain the role of dextrose in PMF have focused for the most     part on the high intracellular concentrations of glucose without consideration to the     potential pathogenic role of the glucose transporters which allow glucose entry into the     cell. Experimental evidence in non-mesothelial cell lines indicate that some cellular     processes that occur under high glucose conditions may not be related to intracellular     glucose metabolism but to the type of glucose transporter allowing glucose entry. 3,4     However, little is known about these glucose transporters in peritoneal mesothelial cells and     their potential role in the development of PMF.      We hypothesize the following        -  The presence of Sodium Glucose Co-transporter (SGLT1) on peritoneal mesothelial cells          plays a role in PMF under hyperglycemic conditions.        -  Regulation of pro-fibrotic mediators such as reactive oxidative species,transforming          growth factor β, and vascular endothelial growth factor are modulated by SGLT1          activation by glucose rather than glucose metabolism or concentration.        -  Icodextrin does not activate the SGLT1 transporter establishing a mechanism that may          explain the beneficial effects of icodextrin on peritoneal membrane transport.   "
88070|NCT02133300|"     Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular     electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant     side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients     will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and     non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle     strength if the patients are awake and cooperative (using the medical research council scale     and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the     investigators hypothesize that electrical stimulation will preserve muscle mass with respect     to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that     electrical stimulation can reduce muscle strength loss and leads to a better protein balance     and thicker muscle fibers in the stimulated quadriceps.   "
88071|NCT02133287|"     To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating     Coronary Revascularization.   "
88072|NCT02133274|"     The purpose of this study is to determine whether a brief psychosocial intervention together     with early palliative care are feasible, acceptable and effective in the reduction of     depressive symptoms of patients with advanced cancers starting first line palliative     chemotherapy.   "
88073|NCT02133261|"     The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can     serve the same purpose as standard monitoring systems. The new 7day patch is significantly     smaller and lighter than previous ECG recorders.   "
88074|NCT02133248|"     Many people who are on the wait list for a kidney transplant have harmful antibodies, called     donor specific antibodies (DSA), which will attack foreign tissue such as the transplanted     organ. These people are considered to besensitized. Prior to receiving a kidney, these     patients undergo desensitization treatments to remove these harmful antibodies. Levels of DSA     are measured after desensitization, but the cells that produce the DSA, donor specific B     cells (DSB), have not generally been measured. Additionally, if a person experiences chronic     rejection due to antibodies they are also desensitized, but only the DSA are measured. This     study will measure the DSA and, using new techniques, the DSB in two study groups: those who     are receiving an organ and those experiencing chronic antibody mediated rejection after     receiving an organ. The hypothesis is people with higher levels of DSB after desensitization     are more likely to develop antibody mediated rejection.   "
94360|NCT02050997|"     This is an exploratory, translational, non-interventional and multi-centre clinical study.     The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy     in PDAC.   "
88076|NCT02133222|"     Therapies that target specific molecules markedly inhibit cancer growth in several     malignancies, and provide valuable strategies for the treatment of advanced melanoma. In     recent years, BRAF and KIT have become established therapeutic targets in melanoma patients     showing activating mutations in these oncogenes. However, it is crucial that genetic     mutations present in the melanoma lesions are identified if the investigators are to design     tailormade therapies for individual patients. The tumour genotypes that determine the     selection of molecular-targeted therapies are usually identified in primary tumours; however,     primary tumours are not always representative of metastases. Circulating free DNA may be a     source of valuable information because it can be obtained via routine blood sampling, it     provides real-time information about a patient's current disease state, and it allows     monitoring and molecular characterization before and after chemotherapy. The aim of the study     is to determine the mutational status in circulating DNA in melanoma metastatic patients,     with the Sequenom Mass Array, a next generation sequencing technology. Results obtained     before and after treatment will be compared with the primary tumor genotype.   "
88077|NCT02133209|"     112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress     Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including     headache frequency and impact and brain activity, will be assessed at baseline, prior to     intervention, and at 3-, 6-, and 12-months.   "
88078|NCT02133196|"     Background:      The NCI Surgery Branch has developed an experimental therapy that involves taking white blood     cells from patients' tumors, growing them in the laboratory in large numbers, and then giving     the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL     and we have given this type of treatment to over 100 patients. In this study, we are     selecting a specific subset of white blood cells from the tumor that we think are the most     effective in fighting tumors and will use only these cells in making the tumor fighting     cells.      Objective:      The purpose of this study is to see if these specifically selected tumor fighting cells can     cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is     safe.      Eligibility:      - Adults age 18-70 with NSCLC who have a tumor that can be safely removed.      Design:        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as          needed        -  Surgery: If the patients meet all of the requirements for the study they will undergo          surgery to remove a tumor that can be used to grow the TIL product.        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood          cells. {Leukapheresis is a common procedure, which removes only the white blood cells          from the patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the          hospital for about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits take up to 2 days.   "
88079|NCT02133183|"     This partially randomized pilot trial studies how much sapanisertib reaches the brain tumor     and how well it works when given before and after surgery in treating patients with     glioblastoma that has grown or come back and requires surgery. Sapanisertib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
88080|NCT02133170|"     This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator)     controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder     (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are     assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus     Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus     structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric     care with standard pharmacologic treatment.   "
88081|NCT02133157|"     Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular     endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has     demonstrated potent inhibitory effects on multiple human tumor xenografts. This     first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended     dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor     activity of HMPL-012 at single doses and multiple doses .   "
88082|NCT02133144|"     A. BACKGROUND Accumulation of fat in the liver due to non-alcoholic causes (NAFLD) is     associated with hepatic insulin resistance, which impairs the ability of insulin to inhibit     the production of glucose and VLDL . This leads to increases in serum glucose, insulin and     triglyceride concentrations as well as hyperinsulinemia. Recent epidemiologic studies have     shown that a major reason for the metabolic syndrome as well as the accompanying increased     risk of cardiovascular disease and type 2 diabetes is overconsumption of simple sugars. The     investigators have recently shown that overeating simple sugars (1000 extra calories/day,     CANDY diet) increases liver fat content by 30% within 3 weeks (4), and recapitulates     features of the metabolic syndrome such as hypertriglyceridemia and a low HDL cholesterol     concentration.      The fatty acids in intrahepatocellular triglycerides may originate from peripheral lipolysis,     de novo lipogenesis, uptake of chylomicron remnants by the liver and from hepatic uptake of     fatty acids released during intravascular hydrolysis of triglyceride-rich lipoproteins (the     spillover pathway). A classic study using stable isotope methodology by the group of     Elisabeth Parks showed that in subjects with NAFLD, the excess intrahepatocellular     triglycerides originate from peripheral lipolysis and de novo lipogenesis.      It is well-established that ingestion of a high carbohydrate as compared to high fat diet     stimulates de novo lipogenesis in humans. Meta-analyses comparing isocaloric high fat and     high carbohydrate diets have shown that high carbohydrate but not high fat diets increase     increase serum triglycerides and lower HDL cholesterol. Since hypertriglyceridemia results     from overproduction of VLDL from the liver, these data suggest the composition of the diet     influences hepatic lipid metabolism. Whether this is because overfeeding fat leads to     preferential deposition of fat in adipose tissue while high carbohydrate diets induce a     relative greater increase in liver fat is unknown. There are no previous studies comparing     effects of chronic overfeeding of fat as compared to carbohydrate on liver fat or and the     sources of intrahepatic fatty acids.      A common polymorphism in PNPLA3 at rs738409 (adiponutrin) gene is associated with a markedly     increase liver fat content. This finding has been replicated in at least 20 studies across     the world. The investigators have shown that PNPLA3 is regulated by the carbohydrate response     element binding protein 1. Mice overexpressing the human I148M PNPLA3 variant in the liver     exhibit an increase in liver triglycerides and cholesteryl esters on a high sucrose but not     high fat diet. These data suggest that overfeeding a high carbohydrate as compared to a high     fat diet may increase liver fat more in subjects carrying the I148M allele than in     non-carriers.      B. HYPOTHESIS The investigators hypothesize that overfeeding a high fat as compared to an     isocaloric high carbohydrate diet influences the source of intrahepatocellular triglycerides.     During a high fat diet, relatively more of intrahepatocellular triglycerides originate from     peripheral lipolysis and less from DNL than during a high carbohydrate diet in the face of a     similar increase in liver fat. It is also possible given the lack of previous overfeeding     data comparing 2 different overfeeding diets that the high fat diet induces a smaller     increase in liver fat than a high carbohydrate diet even in the face of an identical increase     in caloric intake because a greater fraction of ingested fat is channeled to adipose tissue     than the liver. The investigators also hypothesize that liver fat may increase more in     carriers than non-carriers of the I148M variant in PNPLA3 during a high carbohydrate than a     high fat diet.      C. SPECIFIC AIMS The investigators wish to randomize, using the method of minimization     (considers baseline age, BMI, gender, liver fat, PNPLA3 genotype) 40 non-diabetic subjects     with NAFLD as determined by the non-invasive score developed in our laboratory or previous     knowledge of liver fat content based on MRS to overeat either a high carbohydrate or high fat     diet (1000 extra calories per day) for 3 weeks. Before and after the overfeeding diets, will     measure liver fat content by 1H-MRS and the rate of adipose tissue lipolysis using doubly     labeled water (DDW) and [1,1,2,3,3-2H5] glycerol as described in detail below. The     investigators also wish to characterize glucose, insulin, fatty acid and triacylglyceride     profiles before and while on the experimental diet. An adipose tissue biopsy is taken to     determine whether expression of genes involved in lipogenesis or lipolysis, or those involved     in adipose tissue inflammation change in response to overfeeding, and for measurement of LPL     activity. After overfeeding, both groups will undergo weight loss to restore normal weight as     described in our recent study. The metabolic study is repeated after weight loss.   "
88083|NCT02133131|"     This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in     treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The     objective is to determine the proportion of participants achieving sustained virologic     response 12 weeks after ending study treatment (SVR12).   "
88084|NCT02133118|"     Next to HbA1c, body weight is regarded as an important surrogate end-point in trials     investigating glucose-lowering agents. An increase in weight could contribute to worsening     insulin resistance. Differences in weight after starting glucose lowering agents have been     described in many randomized controlled trials (RCTs).      With this prospective observational study, weight trajectories after receiving add-on therapy     next to metformin are evaluated in primary care patients with good glycaemic control.   "
88085|NCT02133105|"     Although inotropes have a favorable effect on central hemodynamics in patients with heart     failure, their effect on renal hemodynamics is incompletely defined. The purpose of this     study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared     to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with     chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that     patients treated with levosimendan will show greater increases in renal blood flow and     glomerular filtration rate (GFR) than those treated with dobutamine.   "
88086|NCT02133092|"     The purpose of the study is to assess viral kinetics and clinical symptoms kinetics in     pediatric patients hospitalized with Respiratory Syncytial Virus (RSV) confirmed lower     respiratory tract infection (LRTI).   "
88087|NCT02133079|"     To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and     Pancreatic Adenocarcinoma   "
88088|NCT02133066|"     The reported rate of unsuccessful spinal taps in children, especially young infants, is high.     Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.   "
88089|NCT02133053|"     This is a comparative, open label, parallel group, non interventional study to further     demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition     the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient     applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the     instructions for use. The observation takes place over a period of 14 days. Response to     treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a     dairy.   "
88091|NCT02133027|"     Objective:To explore the role of the right portal pedicle and Rouviere's sulcus as an     anatomic landmark in laparoscopic cholecystectomy.      Methods:The investigators are going to select 60 patients intending to perform Laparoscopic     cholecystectomy from April 2014 to April 2015.Check out the presence of the right portal     pedicle and Rouviere's sulcus during the surgery and divide into the experimental group and     the control group.Experimental group operated in Laparoscopic cholecystectomy with the guide     of Rouviere's sulcus while the Control group operated with the traditional way.      Research hypothesis:Compare the differences between the Experimental group and the Control     group in bile duct injury rate,complication rate,blood loss,operative time ,conversion rate     and hospital stay.It is supposed that the results of Experimental group are superior to the     control group,difference is statistically significant(P<0.05). So the investigators can draw     the conclusion that the anatomy method with the guide of right portal pedicle and Rouviere's     sulcus is useful in laparoscopic cholecystectomy.   "
88092|NCT02133014|"     The purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous     catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases SAP     patients from April 2014 to April 2015 who carry on the treatment in our hospital,and divide     into the experimental group and control group under respect the wishes of patient in the     case.The experimental group use the method of laparoscopic-assisted percutaneous drainage to     carry on the treatment,the control group patients use conventional conservative therapy to     carry on the treatment.Contrastive analyze two groups of patients clinical care effects.      Research hypothesis:according to compare the mortality,the incidence of complications     ,hospital stay and other research indicators of two groups .It is supposed that the research     indicators of experimental group are lower than the control group ,difference was     statistically significant(P<0.05).We can draw the conclusion that the method of     laparoscopic-assisted percutaneous catheter drainage of early SAP is useful and deserve to be     promoted on clinical.   "
88093|NCT02133001|"     The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram     (mg) compared with intranasal placebo along with standard care treatment, in reducing the     symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a     dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is     prominent and relatively persistent), including the risk for suicide as assessed by the     Investigator, in participants who will be assessed to be at imminent risk for suicide.   "
88094|NCT02132988|"     The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving     Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian,     fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based     chemotherapy as initial treatment for primary disease or as salvage treatment for first     relapse.   "
88095|NCT02132975|"     Study, for the first time in clinical conditions, the potential contribution, in terms of     accuracy, of the motorised probe holder during prostate biopsies.   "
88096|NCT02132962|"     The study investigates the effect of aminoacid infusion on proteinturnover in muscle from     cirrhosis subjects, compared to healthy controls.      The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation     that follows cirrhosis.   "
88097|NCT02132949|"     This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the     safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and     anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive     locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a     treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for     Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by     paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment     regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC),     followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel.     Participants in both cohorts will subsequently undergo surgical treatment and then resume     pertuzumab and trastuzumab treatment.   "
88098|NCT02132936|"     The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of     calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis     vulgaris   "
88099|NCT02132923|"     The purpose of the study is to assess viral kinetics and clinical symptoms kinetics of     Respiratory Syncytial Virus (RSV) in pediatric patients hospitalized with RSV confirmed lower     respiratory tract infection (LRTI).   "
88100|NCT02132910|"     The purpose of the study is to learn about the effect of integrative therapies on chronic or     recurrent low back pain.      The intervention called RESTORE (Restorative Exercises for Strength Training and Operational     Resilience) is based on a series of gentle stretching and strengthening exercises     incorporating breath-work and mindfulness. The study is designed to discover the impact of     RESTORE on pain levels, physical function, and behavioral health.   "
88101|NCT02132897|"     Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer     drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with     time due to metabolism autoinduction.      The primary objective of this study is to estimate the bioequivalence of the new brand     generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product     (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary objective     will be evaluation of safety issues.      The study design will be randomized two sequences, two periods and crossover. For a power of     not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be     administered with food (high calories/high fat breakfast) after an overnight fast.      Time vs. concentration curves will be built for each subject and formulation and Area Under     Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to     infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual     curves.      This parameters will be statistically processed with the WinNonlin 6.3     Pharmacokinetics/Statistic software in order to prove bioequivalence between the study     products.   "
88188|NCT02131740|"     This study addresses the research question:      How does eye rubbing affect corneal (clear part of eye) parameters in healthy volunteers      The study objectives are:        1. To determine the corneal changes following eye rubbing        2. To assess tear film changes following eye rubbing        3. To investigate if there is an association between eye rubbing and axial length of the          eye.   "
88105|NCT02132845|"     This randomized clinical trial studies how well next generation sequence target-directed     therapy works in treating patients with cancer. Next generation sequencing is a test that     screens for mutations to cancer related genes. Target-directed therapy is a type of treatment     that uses drugs or other substances to identify and attack specific types of cancer cells     that may have less harm to normal cells. Next generation sequencing may help identify these     specific types of cancer cells.   "
88106|NCT02132832|"     This project has two primary goals. The first goal is to further scientific understanding     about marijuana abuse by examining two recognized factors in marijuana use and relapse: (1)     stress/anxiety and (2) atypical reactivity to marijuana-related stimuli (e.g., attentional     bias). The second goal is to attenuate the influence of stress/anxiety and attentional bias     to marijuana stimuli via administration of buspirone.      Buspirone is uniquely suited to this project because it has effects on neurotransmitter     systems known to modulate both stress/anxiety and attentional bias.   "
88107|NCT02132819|"     Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are     afraid of facing during the follow up of newborns. During the last years, investigators ran     retrospective observational studies abut NEC developing within the 48 hours after red blood     cell transfusion. In the previous studies, the incidence of transfusion associated NEC     (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for     retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about     transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to     transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology     clinics, withholding feeds during transfusion is not preferred. But several recent studies     show an increase in the incidence of TANEC if the newborn goes on feeding before, during and     after the transfusion process, especially if it is fed with a formula. The main aim of this     study is to investigate the effect of withholding feeds during transfusion, on the     development of TRAGI.   "
88108|NCT02132806|"     The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment     of class II furcation involvement using biomaterials and new surgical techniques   "
88109|NCT02132793|"     The immediate objective of this project was to demonstrate the feasibility of Remote     Exercises for Learning Anger and Excitation Management (RELAX). The application is a remote,     technology- enabled, anger treatment and management system based on current evidence-based     CBT interventions. The project's objective was to show that RELAX (1) enables the practice of     anger management strategies remotely through mobile phone interfaces; (2) integrates with     evidence-based treatments through the implementation of an existing CBT anger management     course; (3) provides information, direction, and feedback through physiological sensors and     signal analysis; and (4) supports communication and direction by the therapist through a     web-based therapist interface.   "
88110|NCT02132780|"     There is a significant association between autonomic dysfunction and symptoms experienced by     NAFLD patients mediated by increased systemic inflammation and insulin resistance, resulting     in deteriorating quality of life of affected patients; fatigue and other symptoms drive     worsening autonomic dysfunction in these patients. We aim to describe the severity of     autonomic dysfunction (AD) in non-alcoholic fatty liver disease (NAFLD) and the relationship     of AD to symptoms experienced by NAFLD patients (such as fatigue, chronic pain, depression,     sleep disturbance, and cognitive dysfunction), and to the quality of life of NAFLD patients.     We also hope to examine the impact of systemic inflammation and insulin resistance as     mediators of manifestations of AD and symptoms experienced by NAFLD patients.   "
88111|NCT02132767|"     The purpose of this study is to compare the therapeutic strategies of rate control versus     rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial     fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after     cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in     hospital within 60 days of the occurrence of AF compared to a strategy of rate control.   "
88112|NCT02132754|"     This is a 5-part dose-escalation study to determine the maximum tolerated dose (MTD)/maximum     administered dose (MAD) of MK-4166 in participants with advanced solid tumors. In Part A,     MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may     progress to Part B, in which the preliminary MTD will be identified. Based on safety events     the study may progress to Part C in which the MTD will be confirmed. In Part D, participants     will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg     to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in     Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with     pembrolizumab will be confirmed.      With Amendments 05/06, the dose confirmation Part E (combination of MK-4166 and     pembrolizumab) will be limited to participants with advanced malignant melanoma.      The primary study hypotheses are that MK-4166 as a single agent and MK-4166 in combination     with pembrolizumab have acceptable safety and tolerability.   "
88113|NCT02132741|"     Patients with high blood pressure (hypertension) and chronic kidney disease are at an     increased risk of developing heart disease and strokes. Part of this risk is due to changes     in the structure and function of the blood vessels throughout the body. It is thought that     reducing high blood pressure and treating chronic kidney disease improves the structure and     function of blood vessels but information on this is limited. Optical coherence tomography     (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple,     quick and non-invasive test that you may have previously had during a visit to the optician.     The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's     blood vessels in patients with hypertension and chronic kidney disease compared to healthy     individuals and also to see if any differences seen improve with treatment.   "
88114|NCT02132728|"     This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and     inflammatory indicators in male workers of a food industry.   "
88227|NCT02131233|"     To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily     in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with     TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested     is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg     twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of     participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.   "
88115|NCT02132715|"     As the U.S. population ages and the prevalence of osteoarthritis (OA) among older adults     rises, the prevention of OA-associated disability is an important public health priority.     Accordingly, efficacious interventions are needed to manage pain and maintain physical     function among older adults with OA. Because skeletal muscle weakness is a primary     contributory factor to the progression of pain and functional decline among persons with OA,     optimal interventions are those capable of improving skeletal muscle strength. High-intensity     resistance exercise is the best-known method of improving muscle strength; however     high-compressive loads typically induce significant joint pain among persons with OA.     Accordingly, current recommendations include the performance of low- or moderate-intensity     physical exercise - despite the fact that these training paradigms are sub-optimal for     enhancing muscle strength. This application proposes conduct a pilot study to investigate the     potential of an innovative training paradigm with potential to stimulate improvements in     skeletal muscle strength while utilizing low-intensity loads. This paradigm, known as KAATSU     training, involves performing low-intensity exercise while externally-applied compression     mildly restricts blood flow to the active skeletal muscle. The overarching objective of the     present application is to evaluate the efficacy and feasibility of chronic KAATSU training     for the improvement of skeletal muscle strength and physical function among persons aged > 60     years with symptomatic knee OA and mild to moderate physical limitations. Up to 72     participants will be recruited to participate in this three month intervention study.     Participants will be randomly assigned to one of two intervention conditions: (1) a standard     exercise intervention consisting of center-based, moderate-intensity resistance training, or     (2) a KAATSU training program matched for overall workload. This study will provide novel     information regarding the therapeutic potential of KAATSU training for improving strength and     function as well as attenuating pain among these individuals. The study will also provide     critical information regarding the long-term, clinical viability of the paradigm by     evaluating participant safety, discomfort, and willingness to continually engage in the     KAATSU training program.   "
88116|NCT02132702|"     This study is to evaluate the performance attributes and user progression of participants     with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic     exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in     progression and overall health while using Ekso.   "
88117|NCT02132689|"     Currently there is no clear guidance for the treatment of moderate risk of pulmonary     embolism. The aim of the study is to compare two different therapeutic modalities - standard     anticoagulation versus thrombolytic treatment followed by anticoagulation in standard regimen     as stated in the pulmonary embolism guidelines.   "
88118|NCT02132676|"     The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in     addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of     diabetes in five VA health systems, and to study the implementation process in order to     gather information required to disseminate the program more broadly in the VHA system.   "
88119|NCT02132663|"     This clinical trial will evaluate an investigational infant formula with an alternate source     of DHA to determine if it provides normal growth and if it is well tolerated by term infants     as compared to a marketed routine infant formula.   "
88120|NCT02132650|"     The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of     older Veterans grows, stroke will become an increasingly important problem to the VHA.     Recovery of walking function is the most common goal of stroke survivors. The proposed study     will test whether training with accurate walking tasks to engage the damaged supraspinal     motor pathways is more effective than training with steady state walking. The investigators     expect that training accurate tasks will be more effective, thereby improving walking     function of Veteran stroke survivors and reducing the burden of care placed on families and     on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost     to existing rehabilitation approaches, which is important given that the VHA invests $88     million per year toward outpatient care, including physical rehabilitation, in the first six     months after stroke. This research also has implications for rehabilitation of other     neurologically injured populations, including traumatic brain injury and incomplete spinal     cord injury.   "
88121|NCT02132637|"     The primary purpose of this study is to compare the effect of double doses of a study drug     known as insulin peglispro and insulin glargine in participants who have type 2 diabetes.     Participants will be treated for up to 11 weeks, and will take part in two study periods.     Each participant will receive insulin peglispro during one treatment period and insulin     glargine during the other treatment period.   "
88122|NCT02132624|"     Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and     efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting     antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and     4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus     vector. Prior to T cell infusion, the patients will be subjected to preconditioning     treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse     reactions, persistence of CAR T cells and efficacy.   "
88123|NCT02132611|"     The purpose of the COAST clinical study data will be to utilize and to gain approval for     commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).   "
88124|NCT02132598|"     This is an open-label phase II clinical trial designed to allow a preliminary assessment of     the efficacy and safety of cabozantinib in unselected Non-Small Cell Lung Cancer (NSCLC)     patients with metastases to the brain and in the subset of patients with c-MET amplified     Non-Small Cell Lung Cancer with metastases to the brain. Previously treated patients with     non-squamous NSCLC who have had brain metastases at any point in their treatment history are     eligible for enrollment on this clinical trial. Patients with clinically asymptomatic     untreated brain metastases will be allowed on trial at the discretion of the treating     investigator. Patients who have undergone treatment for their brain metastases with     Whole-Brain Radiation Therapy (WBRT), stereotactic radiosurgery (SRS) or surgery must be     clinically stable and recovered from all procedures at the time of study enrollment.   "
88125|NCT02132585|"     Speckle tracking (STE) is a novel echocardiographic technique which permits calculation of     myocardial velocities and deformation parameters such as strain and strain rate (SR). It is     demonstrated that these parameters provide important insights into systolic and diastolic     function, ischaemia, myocardial mechanics and many other pathophysiological processes of the     heart. In this preliminary study, we investigated the role of STE in detection of early     ventricular dysfunction in patients with Sjogren Syndrome, focusing on cardiorespiratory     fitness.   "
88126|NCT02132572|"     Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of     reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)   "
88189|NCT02131727|"     The purpose of this study is to determine if a simple intervention to improve hand hygiene,     consisting of a 3-4 minute training video, on-site posters, and hand hygiene supplies, can     reduce respiratory and GI illness among employees.   "
88127|NCT02132559|"     Women with low ovarian reserve typically respond less well to the drugs used to stimulate the     ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall     pregnant either naturally or after fertility treatment. The ideal stimulation regimen for     poor responders is currently unknown.      Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor     responders, and is now utilized by approximately one third of all IVF centers world-wide.     However, the current clinical evidence for DHEA on improvement of ovarian response and IVF     outcome is insufficient. The validity of the results of the former studies, especially the     varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a     uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the     European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been     performed study to evaluate the potential effects of DHEA supplementation according to these     standards.      The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of     poor ovarian responders that fulfill the Bologna criteria.   "
88128|NCT02132546|"     The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis     the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system     (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. The     efficacy of the products and the patient's opinion and acceptance were also assessed.   "
88129|NCT02132533|"     The purpose of this study is to determine if nifedipine treatment of women in preterm labor     receiving corticosteroids results in postponement of delivery when compared to placebo.   "
88130|NCT02132520|"     The purpose of this study is to determine whether the combination of low frequency repetitive     transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface     (BCI) training is effective for enhancing motor recovery after stroke.      The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects     receiving supplementary rTMS and BCI training will show greater functional improvements in     hand motor ability over time as well as recovery of normal motor connectivity patterns.   "
88131|NCT02132507|"     The purpose of the study is to evaluate a new technology for functional neuroimaging using     electroencephalography (EEG) and MRI in studying epilepsy.   "
88132|NCT02132494|"     The relationship between physical activity and academic performance has received widespread     attention owing to the pressure on schools to graduate pupils who meet accepted academic     standards. As important, there are global concerns regarding the increased prevalence of     lifestyle-related non-communicable diseases (NCDs). First, Norway has a history of mediocre     scores on international comparative academic performance tests such as Trends in     International Mathematics and Science Study (TIMSS) and the Programme for International     Student Assessment (PISA) [1]. It is therefore important to develop and evaluate strategic     programs that may enhance pupil's academic performance. It is increasingly evident that a     physical activity strategy that brings about enhanced cognitive function, better blood flow,     and more, plays a key role in this effort [2]. Second, the prevalence of NCDs, such as     diabetes mellitus type 2, is increasing worldwide, and such NCDs affect people of all ages     [3]. Hence, healthcare costs are escalating to unaffordable levels. The best means to deal     with this immense problem is through primary prevention, and physical activity is a powerful     common denominator known to play a key role in preventing a host of NCDs [4].      Consequently, both World Health Organization (WHO) and the Norwegian health authorities call     for effective primary prevention strategies to promote physical activity in children and     adolescents [5, 6]. Prop. 90 L (2010-2011) Act on public health work [6] emphasizes that     physical activity in school can benefit both the learning process and public health     prevention.      Therefore, the objective of the ASK-study is to investigate the effects on academic     performance of 60 minutes of daily physical activity during one school year. Furthermore, due     to the complexity in the relationship between physical activity and academic performance, it     is necessary to identify possible mediating and moderating variables as cognitive     performance, quality of life (QoL), classroom behavior, motor skills and motivation. Also, we     aim to investigate changes in risk factors related to NCDs and factors that influence NSDs,     such as physical activity, sedentary behavior and health-related fitness.      In addition a qualitative part of the ASK-Study will be conducted to get an in-depth     understanding of the children's embodied experiences and the meaning of the social learning     culture in school physical activity (PA). This will give us an in-depth description of the     intervention context, offer insight in how the intervention possibly influences children's     overall development and enables us to estimate potential long term effects of the     intervention.      If successful, the ASK cluster-randomized controlled trial (RCT) could provide much needed     solutions to enhancing schoolchildren's academic performance and position the school as an     effective setting for a massive public health intervention concerning the prevention of NCDs.   "
88133|NCT02132481|"     The primary goal of the proposed trial is to examine the effect of combining frequent     self-monitoring via Ecological Momentary Assessment (EMAs) and automated interventions via     Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from     drugs and alcohol and HIV risk behaviors over 6 months following treatment discharge. We will     recruit 400 participants at discharge (both planned or unplanned) from Illinois' largest     treatment organization and randomly assign them in a 2 x 2 factorial design to receive EMA     only, EMI only, combined EMA+EMI, or neither (control). Participants in the 3 EMA and EMI     groups will receive a smartphone and training after discharge. To help them self-monitor,     individuals in the EMA groups will be randomly signaled 6 times daily for 6 months and asked     to record their recent substance use, HIV risk behaviors (e.g., needle use, unprotected sex)     and exposure to internal and external protective and risk factors, then to rate the extent to     which these factors support their recovery or make them want to use drugs or alcohol.     Individuals in the EMI groups will have 24/7 access to a smartphone recovery support system.     In the combined EMA+EMI group, participants will receive feedback directly following     completion of each 2-3 minute EMA, and EMA responses will be used to encourage EMI     utilization. The primary hypotheses are      H1 Random assignment to a) EMA (vs. not), b) EMI (vs. not), and c) their interaction will be     associated with more days of abstinence from drugs and alcohol over the 6 months post     discharge.      H2 Random assignment to a) EMA, b) EMI, and c) their interaction will be a associated with     fewer HIV risk behaviors over the 6 months post discharge.      H3 Days abstinent at 3 months post discharge will mediate the effects of a) EMA, b) EMI and     c) their interaction on HIV Risk behavior at 6 months post discharge.   "
88134|NCT02132468|"     This study will investigate the safety, symptoms and biomarker response of subjects with     biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic     PNETs or GI-NETs with elevated biochemical markers who have relapsed during or after     receiving prior standard of care therapies, including octreotide, chemotherapy or targeted     therapy.   "
88135|NCT02132455|"     The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find     early precancerous growth in the colon (polyps) and remove them before they turn into cancer.     The doctor performing the procedure will first advance the colonoscope to the end of the     colon (cecum) and then he will examine the colon for polyps while he is withdrawing the     colonoscope. The period of time that the doctor spent examining the colon called withdrawal     time. Usually doctors will spend at least 6 minutes examining the colon after he reached the     cecum. The investigators are proposing that dedicating half of the withdrawal time during     colonoscopy in examining the right side of the colon, will increase the detection of polyps     in the right side of the colon.   "
88136|NCT02132442|"     This study is designed to study the effect of vitamin D intake on the severity of fatty liver     and poor glucose control in patients with type 2 diabetes and fatty liver disease.   "
88137|NCT02132429|"     The primary purpose of this study is to evaluate the safety and tolerability of multiple oral     doses of AMG 333 for 14 days in healthy subjects and migraine subjects. As part of the     secondary objectives, the study will characterize the pharmacokinetic (PK) profile of AMG 333     after multiple oral doses in healthy subjects and migraine subjects, as well as characterize     the effect of multiple doses of AMG 333 on increases in blood pressure (BP) induced by the     cold pressor test (CPT) in healthy subjects.   "
88138|NCT02132416|"     The purpose of this prospective controlled study is to determine whether surgical management     of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for     and the time spent on ventilator compared to a group treated without operation.   "
88139|NCT02132403|"     This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets     an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that     is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in     combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are     taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in     combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard     3+3 design. Treatment continues until disease progression, unacceptable toxicity, physician     discretion, or patient refusal.   "
88140|NCT02132390|"     Compare the potential benefits of adjuvant toremifene with or without goserelin in     premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied     with or without chemotherapy induced amenorrhoea.   "
88199|NCT02131597|"     The goal of this clinical research study is to learn if SGI-110 can help to control MDS. The     safety of this drug will also be studied.   "
88142|NCT02132351|"     Due to the limitations and the invasive nature of liver biopsy, there has been extensive     interest in developing non-invasive tests to measure liver fibrosis (1). These are     alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of     cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include     radiological studies, transient elastography (TE), and serum markers. We aim at studying     acceptability, reliability, applicability and practical aspects of invasive and noninvasive     methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.   "
88143|NCT02132338|"     With health education, patients will have knowledge of the disease and may modify their     attitudes to diabetes. Have a different behavior, will perform self-management of their     health. Will adhere to physical activity, the better control of the disease and have quality     of life. Empower the patient through the educational practices.   "
88144|NCT02132325|"     This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life     Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in     the outpatient medical oncology setting. Investigators hypothesize that providing dignity     therapy to this population will be feasible.   "
88145|NCT02132312|"     The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when     administered in irrigation solution during cataract extraction on intraoperative pupil     diameter, acute postoperative pain, and safety in children birth through 3 years.   "
88146|NCT02132299|"     This trial will evaluate whether relatively non-immune populations in endemic countries can     effectively generate significant cellular and humoral immune responses that confer protection     against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically     active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ     Vaccine) administered intravenously (IV).   "
88147|NCT02132286|"     Major depressive disorder (MDD) is a highly prevalent, chronic and/or recurrent condition     with substantial morbidity and mortality. It is one of the leading causes of disability     worldwide. Despite significant advances in pharmacological treatment for depression over the     last two decades, a significant proportion of patients (10-20%) are resistant to currently     available treatment. The development of new effective treatment for depression is limited by     the fact that MDD is a heterogeneous disorder with subgroups based on variations in     etiological factors and treatment response. Functional magnetic resonance imaging (fMRI)     approaches offer promise in the prediction and evaluation of clinical response of     antidepressant treatment.      Previous fMRI studies have identified increased activity in dorso-lateral prefrontal cortex     (DLPFC) and decreased amygdala activity from the baseline as imaging markers of     antidepressant response in patients with MDD. However, these studies have examined MDD as a     homogenous group without specifying the type of patient group, and brain regions as a priori     hypothesis.We therefore need studies using combined genetics and neuroimaging measures as     biomarkers in the prediction and evaluation of clinical response to antidepressants. In this     study we attempted to determine imaging clinical efficacy markers in previously defined brain     regions (amygdala and prefrontal regions) for two classes of antidepressants (citalopram and     quetiapine extended release (XR)) with differential action on serotonin transporter     inhibition in a subgroup of MDD patients with high risk allele ( S/Lg) of serotonin     transporter gene polymorphism.   "
88148|NCT02132273|"     The investigators hypothesize that use of an educational story with pictures illustrating     overnight sleep study procedure (also called polysomnography or PSG)accompanied by simple     narrative will be a cost-effective, readily accepted intervention that will contribute to     successful completion of sleep studies among children with disabilities. Children who have     been referred for a clinical sleep study at Kennedy Krieger Institute (KKI) will be enrolled     and randomized to either recieve usual care (discussion of polysomnography with referring     clinicians) or educational story intervention. Both groups of participants will be asked to     complete questionnaries before and after the sleep study. Set-up for the sleep study will be     videotaped so that behavior of the child can be evaluated. The investigators will evaluate     whether successful study completion differs between the two groups.   "
88149|NCT02132260|"     The objective of this study is to compare the efficacy and safety of the test formulation of     Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week     study in patients with tinea pedis.   "
88150|NCT02132247|"     The primary purpose of this study is to determine whether Flector Patch is safe for use in     children. The secondary purpose is to assess blood levels of diclofenac, the active     ingredient in Flector Patch.   "
88151|NCT02132234|"     The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha     (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in     patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.   "
88152|NCT02132221|"     This research is being done to better understand how to help patients who are not receiving     enough relief from opioid prescription medications for chronic non-cancer pain. Opioids are a     group of medications that includes morphine, oxycodone-, hydrocodone-, etc. These medications     are also called narcotics. Research has shown that patients not benefiting from their opioid     prescription medication often feel better when they stop taking it. However, stopping or     reducing pain medications can be a difficult transition. Although they do not have much     benefit from their medication, many patients are afraid to stop because they feel these     medications are the only things giving them a bit of relief. Different strategies can be used     to help patients through the period of tapering and it is not clear which one is best. The     investigators will test a specific approach used during regular care in the clinic: cognitive     therapy.   "
88153|NCT02132208|"     A prospective single-centre non-comparative non-interventional open study has been designed     to validate, in a target number of 100 trauma patients, the correlation between TICCS     evaluated on the site of injury and thromboelastography made on a whole blood sample taken at     the latest 30 min after patient's arrival in the resuscitation room.      The aim of this study was to evaluate the capacity to discriminate trauma patients suffering     from active bleeding and arly acute coagulopathy of trauma and needing Damage control     resuscitation from those without this aggravating combination with a new purely clinical     easy-to-measure pre-hospital score: the Trauma Induced Coagulopathy Clinical Score (TICCS).   "
88154|NCT02132195|"     In childhood nephrotic syndrome, the kidneys leak protein, causing body swelling and a     variety of possible complications such as infection, blood clots, and kidney failure. The     first-line treatment for nephrotic syndrome is corticosteroids. Many children respond to     prednisone treatment, but the disease comes back (relapses) when the prednisone is stopped or     the dose is reduced. Children with frequently relapsing or steroid dependent nephrotic     syndrome are at risk for toxicity from frequent exposure to corticosteroids.      Currently, the standard treatment for frequently relapsing and steroid dependent nephrotic     syndrome involves a variety of medications that suppress the immune system, which can produce     serious side effects. We propose a study to examine the effects of a different medication,     ACTH, on nephrotic syndrome. ACTH is a hormone naturally found in the body. Recently, in     adult studies, ACTH has been shown to be effective for the treatment of nephrotic syndrome.     It has also been shown to have mild and reversible side effects. ACTH is potentially an     attractive therapeutic alternative for the treatment of frequently relapsing and steroid     dependent nephrotic syndrome in children. Our study will randomly assign patients with     frequently relapsing or steroid dependent nephrotic syndrome to either ACTH treatment or no     treatment. This will allow us to study the effects of ACTH on this disease and its side     effects, by comparing how patients do on ACTH treatment versus no treatment. We hypothesize     that ACTH gel is superior to no treatment in maintaining remission in children with     frequently relapsing or steroid dependent nephrotic syndrome.   "
88155|NCT02132182|"     The purpose of this study is to identify phenotypic (cell surface receptor expression) and     functional differences in monocyte populations in humans with osteosarcoma as compared to     published historical data on normal human monocyte values.      The biologic similarity between canine and human osteosarcoma makes it a disease model that     holds promise for translational research possibilities. The phenotypic and functional     differences the investigators expect to find in canine and human monocytes between normal and     osteosarcoma subjects in this pilot work will allow us to launch a program of investigations     to further their understanding as to what characteristics are associated with improved     survival in canine and human osteosarcoma. Such data will represent the foundation upon which     the investigators can plan future investigations designed to exploit the potential anti-tumor     capabilities of monocytes and macrophages in canine and human osteosarcoma.   "
88156|NCT02132169|"     The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in     Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic     disease (including allergic conjunctivitis).   "
88157|NCT02132143|"     The purpose of this study compares chemoradiation and sequential chemoradiation about Lung     adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic     method is better for the patients.   "
88158|NCT02132130|"     The goal of the study is to evaluate the safety, tolerability, and the potential ability of     CGF166 delivered through IL-infusion to improve hearing and vestibular function. CGF166 is a     recombinant adenovirus 5 (Ad5) vector containing a cDNA encoding the human Atonal     transcription factor (Hath1).   "
88159|NCT02132117|"     This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream     1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to     severe facial erythema associated with rosacea.   "
88160|NCT02132104|"     The purpose of the study is to evaluate whether human amnion graft reduces the reformation of     severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.   "
88161|NCT02132091|"     Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover     trial. The trial will consist of two, three-week periods of intermittent fasting, where     subjects receive either antioxidant supplementation or placebo, the ordering of which will be     randomly determined. A one-week preconditioning will precede each invention period, and a two     week wash-out period will follow the first intervention period. Serum-based assays will be     performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins, and     markers of mitochondrial biogenesis and aging.      The investigators hypothesize that an intermittent fasting diet in healthy young volunteers     will improve these markers of cellular aging and that these beneficial effects will be     abrogated by the supplementation of antioxidants. This study is a proof-of-principle study     that will shed light on the mechanism and effects of IF as an anti-aging dietary intervention     in the absence of weight loss. It will inform the design of dietary interventions that are     both effective in improving markers of aging and feasible for patients to practice on a     long-term basis.   "
88162|NCT02132078|"     The purpose of this study is to assess incidence, treatment modalities and outcome of     complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant     recipients (LTRs) in order to establish improved treatment strategies in this high risk     patient collective.   "
88163|NCT02132065|"     Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy,     assessment of benefit and opioid reduction.      Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which     infiltrates local anesthetic between the internal oblique and transverse abdominis muscles     and provides analgesia to the parietal peritoneum as well as the skin and muscles of the     anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane     block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional     anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12)     abdominal wall bilaterally using a four-point single-shot technique.      Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain     may have harmful physiologic, psychological consequences which potentially increase the     morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative     pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic     postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8).      Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the     need of morphine postoperatively after radical nephrectomy.      Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to     routine analgesic. To assess the difference in morphine usage in the first 48 hours after     radical nephrectomy with or without applying of unilaterally dual TAP block.   "
88164|NCT02132052|"     Investigators hypothesize that there are specific characteristic of each cognitive and motor     condition that can be defined using brains scans.   "
88165|NCT02132039|"     The study aims to compare the efficacy of a home-based structured exercise programme (12-step     sitting Tai Chi) involving both persons with dementia and their caregivers with a standard     non-exercise social contact control in treating depression among caregivers. The effects of     exercise on their cognition, quality of life and balance ability are also assessed. We will     also examine if BDNF polymorphisms modulate mood changes in response to exercise     intervention. Focus groups will be organised at the end to find out the facilitators and     barriers in taking up exercise. The findings may offer an avenue of intervention by providing     a low cost, relatively safe and effective treatment for dementia caregivers, which may in     turn benefit the persons with dementia.   "
88166|NCT02132026|"     Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes     narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure     and sudden death. It is the commonest valve disease requiring surgery in the developed world     and as the population becomes increasingly older, it is predicted that the prevalence of     aortic stenosis will double in the next 20 years. Currently the only treatment is replacement     of the aortic valve. Whilst this is excellent treatment, not everyone is suitable for it.      The primary objective of our study is to determine whether 2 drugs used in the treatment of     osteoporosis (a condition of bone thinning) can halt/retard the progression of aortic     stenosis. This is on the basis that studies have suggested that altered regulation of calcium     metabolism may be an important mechanism perpetuating the disease. Both drugs work by     reducing calcium release into the bloodstream from bones and therefore calcification of the     aortic valve.      150 patients will therefore be randomly allocated to either of the trial drugs which are     denosumab,the bisphosphonate (alendronic acid), or a placebo.      Positron Emission Tomography (PET) scanning is a technique where biochemically active     molecules are injected and are taken up at sites of ongoing calcification activity where they     emit radiation and can be detected by the PET scanner. We have previously shown that this     technique can demonstrate areas of newly developing calcification on an aortic valve.      We therefore propose that patients receiving bisphosphonates or denosumab will have reduced     evidence of active calcification and slower progression of their disease at two years as     assessed by Echocardiography (ultrasound) and a change in their calcium score (quantity of     calcium on the aortic valve measured using Computed Tomography [CT] ).      The data from this study will then be used to design a larger trial.   "
88167|NCT02132013|"     The purpose of this study is to evaluate the effects and efficacy of dietary sodium     restriction by mean of a new healthcare approach in patients with chronic kidney disease. The     test persons in the intervention group are actively supported to adhere to a restricted     sodium diet with a structured self-regulation program to implement sodium recommendations     that are in current guidelines.   "
88168|NCT02132000|"     In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of     tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated     derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought     to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal     patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.   "
88169|NCT02131987|"     Between January 1 2006 and December 31 2013, at our department 324 patients underwent     hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis     (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with     pathological fractures and HA performed with direct lateral approach were excluded. A     retrospective cohort study were conducted. Patients with prosthetic dislocation formed one     group and patients without dislocation formed the control group.      As standard, post surgery radiographs (anteroposterior and lateral) were taken. After these     were performed patient started weight bearing as soon as possible. Clinical data regarding     patient demographics, details of the surgical procedure and the medical comorbidities were     collected by the use of patient and operative records. Radiological analysis with position     evaluation was performed using the post surgery radiographs by measuring Wiberg angle,     inequality of leg length and femoral offset of the prostheses and compared with non-operated     hip joint using the post surgery x-ray images.      Our hypothesis were that patients with single- or recurrent dislocations had shortened     postoperative leg length, decreased femoral offsed and a Wiberg angle less than 25 degrees.   "
88170|NCT02131974|"     The purpose of this research study is to help determine if the cuff of an endotracheal tube (     ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if     visualization of this tube corresponds with correct tube depth. You are being asked to     participate because you will be undergoing a cardiac catherization procedure which will     involve endotracheal intubation.      Ultrasound is a safe technology that your doctor could possibly use to see the breathing     tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We     are trying to see if we can avoid using x-rays.      This is a local study with 1 location. The study will enroll a total of 71 people. There is     no sponsor for this study.   "
88171|NCT02131961|"     This study is designed to evaluate the ability to modify a contact cast system so that     topical medications can be applied daily to an underlying wound in patients with diabetic     plantar ulcers. The modification of the cast will be done by making an opening where the     wound is located in the contact cast system. A contact cast system is a device that will     reduce the pressure in the area where the wound is located.   "
88172|NCT02131948|"     It is well known that the hormone insulin lowers blood glucose in part by acting directly on     the liver and reducing hepatic glucose production. Animal studies have shown that the hormone     insulin can act on the brain to indirectly lower glucose production by the liver. We aim to     test whether this is true in humans by giving insulin intranasally. It has previously been     shown that a nasal spray can deliver insulin directly to the brain without affecting     circulating insulin concentration.   "
88173|NCT02131935|"     The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of     endothelial dysfunction could predict occurrence of ISR after percutaneous coronary     intervention (PCI).   "
88174|NCT02131922|"     Hypertensive patients with chronic periodontitis will be randomized to either intensive     treatment or supragingival hygienic treatment and the effects on blood pressure will be     identified.   "
88175|NCT02131909|"     This is a randomized and comparative prospective test, monocentric and controlled (mirror     therapy versus bimanual rehabilitation exercises), in single-blind (investigator and     occupational therapist  1  do not know the type of rehabilitation performed).   "
88200|NCT02131584|"     The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can help to     control fatigue and other symptoms in patients with CLL who do not need treatment for the     cancer. Researchers also want to learn if ruxolitinib can decrease the size of enlarged lymph     nodes and/or lower the number of CLL cells in the blood.   "
88201|NCT02131571|"     Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected     patients older than 50 years.   "
88176|NCT02131896|"     Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic     control: normal glucose homeostasis, normal lipid profile, normal blood pressure and     desirable weight. Controlled nutritional diet, as introduced by the professional committees     aims at achieving better general health condition.      There is a growing body of evidence showing that Mediterranean diet has a major role in     prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of     Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception     of one Italian study.      Six months after education to consume Mediterranean diet in a cohort of 96 children with type     1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary     fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol ratio.      The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the     accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid     profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters,     endothelial function and anthropometric parameters 12 months following diagnosis.      The study designed as a two parallel arms, randomized, single center, intervention study.      Patients enrolled to the study will be randomly assigned, to one of the following groups in a     1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive     nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the     interventional arm will receive regular nutritional instructions in accordance with the     accepted nutritional guidelines   "
88177|NCT02131883|"     Background:      The prevalence of severe health anxiety is reported to be 1-2% in Western communities. This     functional disorder is difficult for medical doctors to treat, the course of the disorder is     often chronic, and that is costly for the social and health care systems as well as for the     patients. A Cochrane metaanalysis from 2009 finds evidence for effectiveness of individual     cognitive behavior therapy (CBT) for patients with hypochondriasis. But no randomised     controlled trials (RCT) of the effectiveness of classical CBT delivered only in groups for     patients with severe health anxiety (hypochondriasis/illness anxiety disorder) has yet been     conducted.      Aims:      1) to examine the effectiveness of group-CBT for patients with severe health anxiety compared     to a wait-list group receiving usual care, 2) to perform a categorical and dimensional     assessment of personality, 3) to examine predictors of outcome especially comorbid     personality disorders, 4) to examine the relation between personality, illness perception and     treatment outcome, 5) to compare the cost-effectiveness of these two treatments, 6) at a 2     years follow up to examine the course and long-term effectiveness of group-CBT for patients     with severe health anxiety and some also followed by psychological treatment for comorbid     personality disorders.      Main hypothesis:      Patients with severe HA who have received group CBT will at 6-month follow-up compared to a     wait-list group receiving usual care show a significantly reduction in health anxiety.      Methods:      84 patients referred from medical doctors during 2014-15 to the Clinic of Liaison Psychiatry     in Koege, Region Zealand, Denmark, will be included and block randomised per 14 patients to     either weekly group-CBT with 7 patients and 2 therapists for 3 hours a week in 12 weeks or     wait-list with usual care for 9 months.      Inclusion: Severe health anxiety (dominant mental disorder), score on WI-7>21,4, age 18-65     years, Danish speaking, informed consent.      Exclusion: Another severe treatment demanding mental disorder, risk of suicide or psychosis,     a serious somatic disease, pregnancy, dependency of drugs, alcohol or medication.      Diagnostic assessment:      The patients are included using research criteria for severe health anxiety (for ICD-11) and     semi-structured interviews developed for DSM-IV, SCAN (general psychopathology) and SCID-II     (personality disorders). Criteria for hypochondriasis from ICD-10 and illness anxiety     disorder/somatic symptom disorder from DSM-5 are used for subcategorising. Dimensions and     traits of personality are assessed by the questionnaire PID-5 included in DSM-5, section III.      Outcome measures:      The primary outcome measure is the questionnaire for health anxiety, Whiteley Index 7 (WI-7),     with a cut-off for remission on 21,4 or a blinded diagnostic assessment of no severe health     anxiety present 6 months after end of treatment.      The secondary outcome measures are questionnaires for health anxiety (HAI), general     psychopathology (SCL-90-R), level of personality disorders (PID-5), level of functioning     (SF-36), quality of life (WHO-5, EQ-5D), Illness perception (IPQ), alcohol consumption (CAGE)     and register data for number of sick days and use of social and health care and a blinded     global assessment of functioning (F-GAF).      Time frame:      Data wil be analysed, and results wil be disseminated from 2016.   "
88178|NCT02131870|"     The purpose of this study is to study the effect of a probiotic product on iron absorption in     healthy females of child-bearing age.   "
88179|NCT02131857|"     Hypothesis 1: Mindfulness is a feasible tool for use within a cystic fibrosis (CF) clinic      Hypothesis 2: Participants in the mindfulness intervention will show an increased level of     quality of life post intervention with the Mindfulness course      Hypothesis 3. Levels of mindfulness:      Participants in the mindfulness intervention will report increased mindfulness levels     post-program completion as compared to pre-program completion      Hypothesis 4. Levels of stress:      Participants in the mindfulness intervention will report lower levels of stress post-program     completion as compared with pre-program commencement.      Hypothesis 5. Levels of residual depressive symptoms post-mindfulness intervention program:     Residual symptoms of depression are a risk factor for relapse of depression. Post -program     participants of mindfulness will purport fewer residual depressive symptoms compared with     pre-program.      Hypothesis 6. CF is associated with severe neutrophilic inflammation of the airways. As     mindfulness intervention has been shown to modulate immune system it may improve physical     aspects of CF including markers of inflammation and markers of lung disease (lung function     tests and rate of pulmonary exacerbations) and nutritional state.   "
88180|NCT02131844|"     Early mobilization (i.e. initiation of out of bed activities from the day of surgery) is     considered an important component of postoperative care after colorectal surgery. Having a     health professional dedicated to facilitate early mobilization has the potential to enhance     postoperative recovery by preventing the negative effects of prolonged bed rest (e.g.     increased risk for complications, muscle loss, deconditioning and functional decline);     however, the need to implement this resource-intensive approach is not evidence based. This     study aims to contribute evidence about the role of facilitated early mobilization as a     strategy to enhance recovery after colorectal surgery.   "
88181|NCT02131831|"     There are several factors that influence telomere length in patients with cirrhosis, such as     metabolic derangements and infectious etiologies, The aim of the study is to compare telomere     length and other parameters related to genetic instability in telomere/ telomerase system, in     peripheral blood lymphocytes in cirrhosis from different etiologies.   "
88182|NCT02131818|"     The purpose of this study is to determine amoxicillin is effective in the prevention of wound     infection in normal labor.   "
88183|NCT02131805|"     The purpose of this study is to assess the effectiveness of electronic skin surface     brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a new     device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy System.     The investigators want to understand what effects, good and/or bad this device for delivering     brachytherapy has on your skin cancer. The investigators also want to assess the safety,     cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging     with clinical response to ESSB.   "
88184|NCT02131792|"     This study was conducted to evaluate results of slanted recession of the lateral rectus     muscle for intermittent exotropia with convergence weakness   "
88185|NCT02131779|"     The objective of the Prostate Cancer Education in African American Churches project is to     develop and evaluate a spiritually-based educational intervention for Informed Decision     Making (IDM) for prostate cancer screening to be delivered to African American men in church     settings.   "
88186|NCT02131766|"     The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin     delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the     system's ability to significantly improve blood glucose levels. This protocol will test the     feasibility of bedside closed-loop control - an approach comprised of standard     sensor-augmented pump therapy during the day using off-the-shelf devices and overnight     closed-loop control using experimental devices in an outpatient setting. The rationale for     this study is as follows: we anticipate that closed-loop control may ultimately be adopted by     patients with T1DM in a selective manner. Patient may choose to start using these systems for     overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while     asleep. To test this paradigm of bedside closed-loop control, subjects will be studied with     continuous glucose monitoring (CGM)-augmented usual pump therapy during the day followed by     overnight use of USS Virginia Closed Loop Control.   "
88187|NCT02131753|"     The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle     of cladribine in patients with hairy cell leukemia requiring treatment.      They have to be untreated so far or may be pretreated with alpha-interferon.   "
89011|NCT02120976|"     The purpose of this study is to evaluate the safety, tolerability, and PK of single oral     doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to     evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2     diabetes mellitus subjects.   "
88190|NCT02131714|"     Pain is an unpleasant sensory and emotional experience that is one of the main symptoms of     temporomandibular disorder (TMD). One way to assess pain is through algometry. The aim of     this study was to evaluate, by the pressure pain threshold measurements, the efficacy of a     short-term conservative treatment for the management of temporomandibular disorders. This     study is a randomized controlled clinical trial where 84 participants were diagnosed with     myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders     (RDC/TMD), with a mean age of 44 years old ranging from 18 to 76 years old. These individuals     were asked about parafunctional habits and the treatment was applied by providing an     explanation concerning the role of pain, possible aetiological factors of the patient's TMD,     the relationship between chronic pain and psychosocial distress, and its benign character.     They also had to perform once daily application of hot packs on both sides of the face for 20     minutes and after that they must perform active free therapeutic exercise of mouth opening     for 10 times. The pressure pain threshold of the masseter and temporalis muscles and the     lateral pole of the condyle were obtained at baseline (T0), between 15 and 30 days after (T1)     and at 75 to 90 days after (T2) representing the end of the treatment. Two groups of subjects     were obtained. The first was considered the study group (SG) and included those who underwent     the treatment proposed. The control group (CG) consisted of participants who did not undergo     treatment because they did not believe in it.   "
88191|NCT02131701|"     The aim of the study is to evaluate the long-term effects of a prescription of exercise     versus a group-based training program on aerobic fitness, muscle strength and metabolic     variables in subjects with poor physical fitness. The participants are further stratified for     a family-history of type 2 diabetes. The number of subjects in each group of intervention is     planned to be 150, aged 30-70 years and non-diabetic.      Intervention: All study subjects take part in two individual sessions for exercise     prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The     prescription group perform exercise by themselves, while the training group will be offered     supervised physical training, including both endurance training and training in gym twice a     week during 12 months.      The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit.      Methods of follow-up: At the study visits physical fitness will be measured by a 2 km walking     test, glucose tolerance by oral glucose tolerance test with measurement of glucose and     insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle, physical     activity, cardiovascular disease and medication.      In the training group 30 subjects with and 30 subjects without a family history of type 2     diabetes will participate in a sub-study including muscle- and fat-biopsy before the start of     the study, after 1 and 5 years.   "
88192|NCT02131688|"     The purpose of this study is to determine the maximum tolerated dose,the safety and     effectiveness of Mitoxantrone Hydrochloride Liposome Injection.   "
88193|NCT02131675|"     Background Type 1 diabetes is characterized by pancreatic beta-cell destruction and an     inability to synthesize insulin. Connecting peptide (C-peptide) is formed from the same     precursor as insulin and is produced in equimolar amounts as insulin. There are several     clinical trials currently being performed to explore the possibility of beta-cell     preservation or regeneration. Most children are not eligible for these trials because it is     often presumed that C-peptide levels will decrease and become undetectable after years of     having type 1 diabetes. Several studies in the adult population have demonstrated that     C-peptide may remain measureable in patients who have had diabetes for up to 50 years after     diagnosis. Recently, it was demonstrated that 10% of adult patients who have had type 1     diabetes for 31-40 years have measureable levels of serum C-peptide if measured with an     ultrasensitive assay. The levels were lower in patients who had diabetes for a longer time.     This pattern was also demonstrated in the Diabetes Control and Complications Trial (DCCT) and     NHANES trial. No studies have been performed exclusively in pediatric patients Hypothesis The     investigators hypothesize that C-peptide should be detectable in the sera of pediatric     patients who have had type 1 diabetes for greater than 1 year and as far out as > 20 years     after diagnosis. The investigators also hypothesize that since their patient population has     had diabetes for less time as compared to adults, the levels of C-peptide should be higher     than reported for adults and that a greater proportion of patients in the pediatric     population will have detectable C-peptide levels as compared to adults.   "
88194|NCT02131662|"     The study is performed to assess the efficacy and safety of different doses of BAY1002670 in     subjects with uterine fibroids. The dose-response relationship will be evaluated. Further,     the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for     BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the     interchangeability of menstrual pictogram and alkaline hematin method for the judgement of     menstrual blood loss will be assessed.   "
88195|NCT02131649|"     The PROPS trial is for men being considered for radiotherapy due to the suspicion that their     prostate cancer has recurred following the surgical removal of their prostate     (prostatectomy). This suspicion is based on rises seen on Prostate Specific Antigen (PSA)     blood tests. Only men who demonstrate the absence of disease on standard imaging scans     (Computed Tomography (CT) and bone scans) will be invited to participate.      This study will be assessing if the imaging probe 18-F Fluorocholine (18F-FCH) used during     Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) scans, can better     predict who will benefit from radiotherapy by identifying the source of cancer recurrence.     This will be determined by measuring the number of men who have disease identified outside of     the prostate bed (the small pocket or depression where the prostate used to be) on their     18F-FCH PET scan. Since F-18-FCH has been shown to be more sensitive in detecting prostate     cancer that may have spread into lymph nodes or bone, it may potentially identify areas of     prostate cancer spread not seen with standard imaging.   "
88196|NCT02131636|"     This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle     for the treatment of persistent moderate to severe facial erythema associated with rosacea.   "
88197|NCT02131623|"     The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment     measure of itching) prior to the analysis of longitudinal treatment effect data being     generated in ongoing clinical trials.   "
88198|NCT02131610|"     Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic     dysfunction in OSA are linked with accelerated cardiovascular morbidity.   "
88202|NCT02131558|"     Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full     bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent     dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be     visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG,     sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will     be identified. SLNs will be surgically removed and provided to Pathology for evaluation.     Non-sentinel nodes will also be surgically removed, as is consistent with routine medical     care for these patients, and given to Pathology for evaluation. A positive SLN may be the     most accurate identifier of the extra-uterine spread of disease, and will provide information     about the extent of surgical node removal necessary.   "
88203|NCT02131545|"     Quetiapine, a second generation antipsychotic, is only available as oral tablets. However,     topical and rectal formulations have been produced in compounding pharmacies. There is no     data available suggesting that topical or rectal formulations provide serum levels similar to     oral medication. In the clinical setting, when oral administration of quetiapine is not     possible (for example, when a patient is extremely ill physically or mentally or both),     clinicians and pharmacists have collaborated in such cases and have at times had to     administer quetiapine compounded in other dosage formulations such as rectal or topical     formulations. Despite clinical effectiveness of these other formulations, there are no     available studies that have investigated blood levels of the drug other than the oral form.     The investigators are therefore designing this pharmacokinetic study to evaluate the the     systemic absorption of quetiapine in oral, rectal and topical formulations. If the     investigators are able to demonstrate detectable levels from rectal and topical quetiapine     formulations compared to the oral form, this knowledge will enhance clinical psychiatric     practice by providing a more broad route of administration for quetiapine which is a commonly     used drug for psychiatric symptoms.   "
88204|NCT02131532|"     Stroke is a leading cause of adult disability in the community. Fatigue affects about a third     of stroke survivors. It results in difficulty taking part in everyday activities, and     increases risk of hospitalization and death after stroke. Despite of its high prevalence and     distressing consequences, there is no effective treatment.      Psychological interventions have improved fatigue in patients with other conditions such as     multiple sclerosis. These interventions primarily target patients' beliefs about overcoming     fatigue and their physical activities in daily life. Also studies indicated that post-stroke     fatigue is associated with mood. Based on this knowledge, the investigator has designed a     brief psychological intervention for post-stroke fatigue.      The current study is a feasibility study to test the adequacy of intervention manuals and the     feasibility of trial processes. This study will need 12 stroke survivors who have post-stroke     fatigue and are over three months but within two years after their stroke. Stroke survivors     with severe depression or having insufficient capability in cognition or communication will     not be included. The investigator will check their eligibility by questionnaires and     interviews and then invite eligible people to take part in the study.      This intervention will be delivered by a therapist (a clinical psychologist) to each     participant through six face-to-face therapy sessions. Each session will be about one hour     and be two weeks' apart. During the sessions, participants will discuss with the therapist     their fatigue problems, and, with the support from the therapist, work out ways to solve     their problems. One month after the last face-to-face session, each participant will receive     a feedback session by telephone from the therapist. Each participant will be followed up to     three months after the last face-to-face session.      After all participants complete their feedback sessions, the investigator will invite them to     a group meeting to share their experiences of taking part in this trial and makes suggestions     as how their experiences of this intervention, and also of this trial, could be improved.   "
88205|NCT02131519|"     Central venous access may be essential in pediatric patients for fluid and a blood product     administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic     monitoring. Obtaining central venous access in pediatric patients can be challenging, failure     rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5%     to 22% The landmark technique has been standard approach for many years. In comparison with     landmark method in pediatric patients the use of ultrasound is associated with an increased     success rate decreased operative time, reduced number of cannulation attempts , and a     decreased number of carotid artery punctures. We wanted to evaluate our success rate using     ultrasound as a guidance during central vein insertion.   "
88206|NCT02131506|"     A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2     positive pretreated Breast Cancer.      Treatment Plan:      Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is     administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined     as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib 1000 mg     die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq &     Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die. Three patients     will be initially enrolled in each dose level starting from level 1. If none of the first     triplet of patients will develop DLT, the dose will be escalated to the next level for the     subsequent three patients. If one of the first triplets of patients will develop first-course     DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is     defined as the dose below that at which two patients have experienced DLT. Lapatinib will be     self-administered by the patient in an outpatient setting at the dose of the assigned step.     Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be     administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to     guarantee a constant speed of infusion) on day      1 of each cycle repeated every 21 days.      STATISTICAL METHODOLOGY:      Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their     first treatment with Caelyx and Lapatinib.      Evaluation of response: all patients included in the study must be assessed for response to     treatment, even if there are major protocol treatment deviations or if they are ineligible.      All conclusions should be based on all eligible patients. Subanalyses may then be performed     on the basis of a subset of patients, excluding those for whom major protocol deviations have     been identified .However, these subanalyses may not serve as the basis for drawing     conclusions concerning treatment efficacy, and the reasons for excluding patients from the     analysis should be clearly reported. The 95% confidence intervals should also be provided.   "
88207|NCT02131493|"     This study is a randomized, open-label, controlled study that will compare the efficacy of     S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients     with surgically resected pancreatic adenocarcinoma.   "
88208|NCT02131480|"     Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when     metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin,     ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first     line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft     tissue.      The trabectedin is a new cancer drug that has obtained marketing authorization after failure     of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It     has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.      This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin     in first-line treatment of uterine or soft tissue leiomyosarcoma.   "
88225|NCT02131259|"     In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the     Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data     for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a     new substance, results of PMS need to be submitted as a part of reexamination dossier to the     Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).   "
88209|NCT02131467|"     Cervical dystonia (CD) is the most common focal dystonia. Currently there are no effective     oral medications for the treatment of CD. While botulinum toxin injections improve symptoms,     they require repeated injections by a trained physician and some patients stop responding to     injections or never respond at all. Therefore, alternative treatment options for CD are     needed. One new agent is a drug that targets glutamate receptors that are thought to be     involved dystonia. This drug, perampanel, was originally developed for epilepsy and is     licensed for use in the USA and Canada for treating epilepsy. The purpose of this study is to     test the effectiveness of perampanel in treating the symptoms of CD.   "
88210|NCT02131454|"     Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the     study is to determine if short training of inhalation technique in patients with obstructive     diseases may influence the course of asthma and COPD.   "
88211|NCT02131441|"     Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally     invasive compared to open liver resection, however, laparoscopic liver resection is still     difficult and risky. Currently it is only carried out in a few large medical centers with     slow development. The related research studies were retrospective analysis, there were no     prospective randomized controlled multi-center study reported. Because of its relatively     simple anatomical advantages, left liver seems to be as the best platform to ensure maximum     safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This     project intends to carry out a prospective randomized controlled multi-center study to look     for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection,     evaluate the long-term efficacy including overall survival, disease-free survival as well as     time to disease recurrence for the left liver carcinoma.   "
88212|NCT02131428|"     Heart failure is the most costly diagnosis in the Medicare population. Clinical depression is     strikingly common in heart failure patients, and not only diminishes their quality of life,     but also is associated with a markedly increased risk of hospitalization or death. This study     is designed to further our understanding of the behavioral and biological effects of     depression in patients with heart failure, so that appropriate treatments can be developed.   "
88213|NCT02131415|"     This is a non-interventional, Canadian, study in patients treated with Abilify Maintena™ for     schizophrenia followed for 24 months, with 9 visits recommended. Study assessments and     administration of questionnaires will take place during the patient regular assessments or     injection visits that are part of routine care. The main objective of the study is to     describe the impact of treatment with Abilify Maintena™ on global functional status.   "
88214|NCT02131402|"     The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens     handling, lens fitting characteristics and visual acuity of different hydrogel lens designs     versus silicone hydrogel lenses   "
88215|NCT02131389|"     The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total     hip replacement surgery.   "
88216|NCT02131376|"     Preserving kidney function during removal of a kidney tumor is becoming increasingly     important as rates of chronic kidney disease increase. A novel modifiable factor (suture     closure of the defect caused by tumor removal) was discovered on retrospective studies to     account for nearly two-thirds of the 15% volume loss commonly seen in operated kidneys. We     hypothesize that a randomized controlled surgical trial will show that omitting the suture     closure both preserves renal function and will not lead to unreasonable postoperative     complications.   "
88217|NCT02131363|"     This purpose of this study is to evaluate the safety and performance of a treatment kit for     ingrowing toenail, primarily by determining the number of subjects who show a reduction in     the severity of their ingrowing toenail.   "
88218|NCT02131350|"     The purpose of this study is to evaluate the mean gain in best corrected visual acuity and     the number of intravitreal ranibizumab (IVR) injections under the combination treatment of     IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable     photocoagulation decreases the number of IVR injections.   "
88219|NCT02131337|"     EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact     force parameters applied for pulmonary vein isolation (PVI) during AF ablation.   "
88220|NCT02131324|"     The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA     (hypothalamic-pituitary-adrenal) axis as compared to Comp01 cream when applied twice daily     for 15 days.   "
88221|NCT02131311|"     This study will evaluate the effectiveness of the pessary device by assessing reduction in     urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight     gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.   "
88222|NCT02131298|"     This study is designed to evaluate the potential effect of itraconazole on the     pharmacokinetics of palbociclib.   "
88223|NCT02131285|"     Background: Balance control relies on accurate perception of visual, somatosensory and     vestibular cues. Sensory flow is impaired in Multiple Sclerosis (MS) and little is known     about the ability of the sensory systems to adapt after neurological lesions reducing sensory     impairment. The aims of the present study were to verify whether:        1. Balance rehabilitation administered in a challenging sensory conditions would improve          stability in upright posture        2. the improvement in a treated sensory condition would transfer to a non treated sensory          condition.      Methods: Fifty three persons with Multiple Sclerosis, median (min-max) Expanded Disability     Status Scale score of 5 (2.5-6.5), participated in a Randomized Controlled Trial and were     randomly assigned to two groups. The Experimental group received balance rehabilitation aimed     at improving motor and sensory strategies. The Control group received rehabilitation     treatment which did not include training of sensory strategies. Persons with Multiple     Sclerosis were blindly assessed by means of a stabilometric platform with eyes open, eyes     closed and dome, on both firm surface and foam. Anterior-posterior and medio-lateral sway,     velocity of sway and the length of Center of Pressure (CoP) trajectory were calculated in the     six sensory conditions.   "
88224|NCT02131272|"     This trial is conducted globally. The aim of the trial is to investigate the efficacy and     safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with     the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children     and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose     of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.   "
88229|NCT02131207|"     This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy     works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves     and a powerful magnet linked to a computer are used to create detailed pictures of areas     inside the body. This diagnostic procedure may aid in identifying lesions in the prostate     which may have cancer. The lesions can then be targeted during the prostate biopsy to improve     the accuracy of identifying prostate cancer.   "
88230|NCT02131194|"     To determine the efficacy of Lenstatin™, an over-the-counter nutritional supplement, in     inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.   "
88231|NCT02131181|"     The purpose of this study is to determine the incidence, long term outcome and factor related     to postoperative delirium in elderly patients after non-cardiac surgery.   "
88232|NCT02131168|"     Crohn's disease and ulcerative colitis are inflammatory disorders of the gut which cause     major life-long disability. They affect males and females, with the commonest age of onset in     childhood, teens and early adult life. Previously restricted almost exclusively to the West,     these conditions are becoming much more common in Asian countries, including Hong Kong - the     cause of this dramatic change is unknown.      The cause of IBD is widely accepted as relating to the mucosal immune response to stimulation     from the gut bacteria, on a background of genetic susceptibility. The bacteria and other     organisms in the gut play a central role in the development of IBD in the West. However it is     unknown if the gut bacteria differ between Chinese patients with IBD and non-IBD (healthy     subjects) in Hong Kong, and whether it is affected by diet or changes in diet. A family     history is the largest risk factor for the disease. More than 50 different genes associated     with IBD have recently been identified in the West and preliminary data showed that Chinese     patients have a different genetic profile to Western populations.      This project aims to explore the true incidence of IBD in Hong Kong and factors that may be     contributing to, or causing, the increase of IBD in Hong Kong. Investigators aim to     investigate the number of new cases of IBD within a five year period and factors that may     account for the cases. Investigators will also study the choice of medical therapy, quality     of life and quality of health care in patients with IBD.   "
88233|NCT02131155|"     This randomised, double-blind phase III trial will be performed in patients with head and     neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy     and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have     received definitive chemo-radiotherapy.   "
88234|NCT02131142|"     The purpose of this study is to collect additional safety and effectiveness data for on the     Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo     coronary artery disease.   "
88235|NCT02131129|"     This study proposes to examine the application of rTMS for the treatment of cognitive     dysfunction in FEP. This is an important population for study because if effective, rTMS may     represent a preventative treatment for the development of social and vocational impairment     that is associated with cognitive dysfunction in schizophrenia. This study will also seek to     refine the understanding of the brain circuitry that mediates the potential pro-cognitive     effects of rTMS through the use of functional magnetic resonance imaging (fMRI) at baseline     and following the course of rTMS administration.   "
88236|NCT02131116|"     Insight, or lack of illness awareness, is a prominent and pressing clinical concern in the     treatment and recovery of patients with psychotic disorders. Impaired insight results in poor     treatment engagement and adherence, more frequent hospitalizations, greater positive and     negative symptoms, and poor psychosocial functioning. Addressing these complications early in     the disease process may lead to altered illness course with better outcomes. To date, only a     small number of nonpharmacological interventions have been developed, none of which     adequately address poor insight during the first few years of psychotic illness. Further,     presently available therapeutic interventions do not attend to difficulties associated with     improved insight, such as depression. The purpose of this investigation is to implement a     novel intervention designed to improve insight, metacognition, neurocognition, symptoms, and     ultimately overall functioning in persons with early psychosis. The novel intervention will     integrate a number of previously established therapeutic approaches, such as metacognitive,     narrative, cognitive behavioral and motivational interviewing, and hence be labeled     Integrated Metacognitive Therapy (IMT). In order to measure the efficacy of IMT, all subjects     will undergo a battery of assessments in each of these domains prior to and following either     a novel intervention (N = 10) or treatment as usual (N = 10) for a period of approximately     six months. Throughout the study, each IMT session (N = 10, 24 sessions each) will be audio     recorded, transcribed, and de-identified to allow for careful ongoing qualitative analyses of     potential active and inert ingredients of the approach and ultimately the development of an     IMT manual which can then be tested in a larger, more rigorous randomized control trial. This     investigation will play an important role in advancing current knowledge about treating     insight in early psychosis. Further, it will serve to expand upon the intervention tools     available by producing a much needed treatment manual designed specifically to target insight     during an illness phase crucial for positive long term outcomes in psychosis.   "
88237|NCT02131103|"     1. Objective: To evaluate short- and long-term in the STEMI patients who successfully          thrombolysis with early routine and delay percutaneous coronary intervention in          low-intermediate risk patients.        2. Educational/ application advantages: To evaluate the time of early and delay PCI after          received fibrinolysis had an effect to the short- and long-term clinical outcomes in          low- intermediate GRACE risk score patients. No available of randomized controlled study          in these group of the patients.   "
88258|NCT02130817|"     The purpose of this study is to evaluate the safety and effectiveness of an immunosuppressive     medication, Belatacept, as a replacement for a calcineurin inhibitor, in combination with a     standard of care regimen of immunosuppressive medications and plasma exchange (plasmapheresis     and immunoglobulin treatment) for kidney transplant patients who are moderately sensitized     against their deceased donor and at-risk for delayed graft function. The hypothesis is that     moderately sensitized patients who receive Belatacept treatment with the standard of care     regimen will lead to lower acute rejection rates than historical controls based on assessment     of standard of care biopsies and standard Banff criteria.   "
88276|NCT02130583|"     The prevalence of suicidal behaviors in adolescents remains unacceptably high and is a     significant public health concern. The investigators propose a new treatment approach in     which skills to increase positive emotions are taught to the most vulnerable at-risk     adolescents, those admitted to an inpatient psychiatric unit due to suicide risk. The     investigators believe that teaching skills to increase positive emotions will lead to better     problem-solving, increased social support, and other benefits which will serve as protective     factors and decrease suicide risk.   "
94403|NCT02050438|"     The purpose of this study is to determine whether different kind of prostesis designs     influences in the quality of life of patients   "
88238|NCT02131090|"     A number of methods are currently used to prevent movement of epidural catheters in women     during labour. These usually consist of sticky dressings applied to the patient's back. The     purpose of this study is to compare how much epidural catheters move when secured with three     commonly used different fixation dressings with the aim of identifying the best method of     securing epidural catheters.      Movement of epidural catheters has several clinical implications. Usually only a short length     of epidural catheter is left in the epidural space, and therefore any significant movement     could result in the catheter moving out of the epidural space leading to a loss of the pain     relieving effects of the epidural.      Once epidural failure has occurred due to catheter migration, a second catheter must be     inserted in order to re-establish pain relief and thus the patient is exposed to the risks of     epidural insertion for a second time.      If the researchers in this study can identify a method of fixing epidural catheters which     results in the least amount of catheter movement, then patients could benefit from more     reliable epidural pain relief, fewer repeated procedures and the risks associated with     repeated procedures.      The principle objective of the study is to determine which epidural fixation dressing results     in the least amount of epidural catheter movement from the time of epidural insertion (during     labour) to the time of epidural removal (after labour).   "
88239|NCT02131077|"     The objective of this study is to evaluate the safety and efficacy of allogeneic     adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.   "
88240|NCT02131064|"     This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants     with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early     breast cancer (EBC) whose primary tumors were greater than or equal to (>/=) 2 centimeters     (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine +     pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab     (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by     surgery, and an adjuvant treatment period.      Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of     consent, or study termination.   "
88241|NCT02131051|"     This is a comparative, open label, parallel group, non interventional study to further     demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops.     In addition the effectiveness and safety shall be compared to Azelastine containing nasal     Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes     Azelastine nasals spray and eye drops according to the instructions for use. The observation     takes place over a period of 7 days. Response to treatment is recorded at day 7 by the     physician and in daily by the patient in a dairy.   "
88242|NCT02131038|"     This is a comparative, open label, parallel group, non interventional study to further     demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray. In addition the     effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray. The     patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray     according to the instructions for use. The observation takes place over a period of 14 days.     Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in     a dairy at defined time intervalls.   "
88243|NCT02131012|"     Intraocular delivery of celecoxib will be an effective means to treat inflammation and     macular edema and prevent structural complications and vision loss in patients with chronic     inflammation or macular edema who are unable to tolerate corticosteroids due to their side     effects.   "
88244|NCT02130999|"     Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24).     Non-24 is very common in people who are totally blind because light can not reset their body     clock. This causes the internal sleep-wake cycle to be out of sync with the 24-hour     day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes     nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming     urge to nap.      Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and intravenously     (I.V.) by infusion through a catheter (not an injection) into a vein. The oral administration     is approved by the FDA. The I.V. administration is considered investigational as it has not     been approved by the FDA. This will be the first time tasimelteon will be given to humans by     intravenous (I.V.) injection.      The purposes of this research study are to:        -  assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body;        -  evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose          and after a single 2 mg I.V. dose;        -  evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20          mg oral dose and after a single 2 mg I.V. dose;        -  evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and        -  evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon.      Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and     eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood     samples will be taken throughout the study for PK analysis.   "
88245|NCT02130986|"     The ProACT study is a 5 year, multicenter study that will test the effect of implementation     of a novel procalcitonin guideline on antibiotic use and adverse outcomes in emergency     department (ED) patients with lower respiratory tract infection (LRTI).   "
88247|NCT02130960|"     This research is being conducted to study the reliability of a method used to measure resting     metabolic rate, or how much energy a person expends while at rest.   "
88248|NCT02130947|"     This randomized pilot study will be conducted in men with metastatic castration resistant     prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The     purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in     mCRPC patients who have recently started on additional androgen suppression therapy.   "
88249|NCT02130934|"     This is a non-randomized prospective pilot study in a single academic center with historic     controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who     have undergone childhood cancer treatment that has cardio-toxic effects to historic controls.     The ultimate goal of this study is to develop a safe and effective method for early diagnosis     of heart problems in children who are receiving chemotherapy treatments that may be toxic to     the heart.   "
88292|NCT02130375|"     The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on     urinary symptoms and female sexual function.   "
88250|NCT02130921|"     This proposed study is an initiative for HIV prevention and care that integrates intervention     efforts at multiple strata: Community Health Workers (CHWs), Injecting Drug Users (IDUs), and     their Family Members (FMs). The proposed study will demonstrate the process of development,     implementation, and evaluation of an intervention for CHWs, IDUs, and their FMs. One aim is     to increase the CHWs' capacities to effectively interact with IDUs and FMs for HIV and drug     use prevention and treatment. Using a combination of participatory action research and a     randomized controlled trial design, this study has the potential to maximize PEPFAR impact in     Vietnam and other PEPFAR-funded countries by identifying a sustainable mix of interventions     and their implementation in different settings. The findings may benefit not only Vietnam but     also a global audience by investigating enhanced methods for controlling the HIV epidemic.   "
88251|NCT02130908|"     This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat     would affect parameters related to health in healthy non-obese adults, and will serve as     basis for future calculation of group sizes in coming studies. Participants consumed     750g/week of fillets of fish or meat for 4 weeks.      Hypothesis:      High intake of either lean or fatty fish will not affect serum concentrations of lipids and     inflammatory markers as well as improve glucose tolerance during the 4 week intervention     period when compared to lean meat intake.   "
88252|NCT02130895|"     This mixed methods study seeks to assess and understand the impact of using an advanced CDS     tool to present the STOPP criteria to support prescribers at the point of decision-making. We     ask the overarching question:      **How can clinical decision support tools effectively translate a complex set of     evidence-based rules into primary care clinical practice?**      The work is divided into 2 phases.      PHASE 1: Randomized control trial. We will measure change in potentially inappropriate     prescribing by primary care prescribers (e.g. family doctors) who are using the Clinical     Decision Support (CDS) tool in their Electronic Medical Record (EMR), as compared to those     who are not. Potentially Inappropriate Prescribing is defined by the STOPP criteria, the same     criteria that will be used in the clinical decision support tool in the EMR. We will use the     OSCAR EMR for this study. EMR based queries will be developed to assess the number of     potentially inappropriate prescriptions are current in each of 12 physician practices at     baseline and at 16 weeks.      PHASE 2: We will then complete a qualitative follow up with participants to aid in     understanding how primary care prescribers perceived the CDS. This will help explain Phase 1     findings and provide additional information to enhance future decision support tools.   "
88253|NCT02130882|"     Background:      - Eosinophils are white blood cells that help fight infections. High eosinophil levels can     damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study     if the drug benralizumab can help people with HES.      Objective:      - To test if benralizumab can safely decrease eosinophils in people with HES.      Eligibility:      - Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have     symptoms and high eosinophil levels.      Design:        -  Participants will be screened with medical history, physical exam, and urine and blood          tests. They will take simple heart and lung tests.        -  Participants will also have a bone marrow biopsy. A numbing medicine is injected into          the outer covering of the bone. Then a needle is inserted into the bone. A fast suction          movement takes bone marrow cells.        -  Phase 1: Participants will randomly receive either the study drug or placebo as an          injection.        -  They will have daily visits for the next 3 days, then 4 weekly visits, and then 4          biweekly visits. Each time, they will have medical history, physical exam, blood tests,          and a check of side effects.        -  They will receive another dose of the study drug or placebo at 1 month and 2 months          after the first injection.        -  Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug.        -  At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the          heart and lung tests. They will also have one other bone marrow biopsy.        -  After week 24, participants will receive the study drug either 6 times over 6 months or          twice over 6 months.   "
88254|NCT02130869|"     This is a pilot clinical trial investigating the addition of haploidentical natural killer     cell infusion to autologous stem cell transplantation. This intervention will be evaluated in     children with high-risk solid tumors for whom autologous transplantation is indicated.     Natural killer cells from a haploidentical family member will be given after high dose     chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma,     the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic     cell recovery will be evaluated and survival of children treated with this approach will be     determined.      The investigators expect to enroll 36 participants. Haploidentical family members (donors)     will also be recruited to provide natural killer cells.   "
88255|NCT02130856|"     There are over 3 million annual neonatal deaths. Approximately 2/3 of neonatal deaths are due     to infection, low birth weight (LBW), and prematurity. Low tech but high impact interventions     and commodities used in unconventional ways could save hundreds of thousands of newborn     lives. We propose an integrated evidence-based toolkit usable by community health workers     (CHW) to reduce neonatal deaths. The kit will include: Chlorhexidine to be applied to the     umbilical stump, sunflower oil emollient to be applied to the skin, ThermoSpot to identify     hypo/hyperthermia, and a Mylar infant sleeve with non-electric warmer.   "
88256|NCT02130843|"     A report of a technique for insertion a soft urodynamic catheter into the bladder, when     urethral obstruction causes the catheter to bend and fold over itself at the resistance site.   "
88257|NCT02130830|"     Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal     disease. However, 90% of patients have some degree of discomfort associated with the     procedure and up to 40% develop clinically significant pain. Some studies have used local     anesthesia to reduce pain with promising results, but the use of topical anesthesia has not     been reported before.      The investigators hypothesize that the use of topical anesthesia before rubber band ligation     significantly reduces post procedure pain.   "
88302|NCT02130245|"     The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The     hypothesis is that to do it as an early intervention after patient admission is better than     delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of     the operative maneuver reflected by operative time, conversion and intraoperative     complications.   "
88259|NCT02130804|"     Background: The prevalence of obesity has increased throughout the last three decades due to     genetic, metabolic, behavioral, and environmental factors. Obesity and high-fat western diets     activate inflammatory processes, which promote development of insulin resistance as well as     other metabolic complications. Increasing obesity rates are a major public health concern in     the Hispanic population due to the large number of Hispanics suffering from obesity. Based on     preliminary data, we propose a double-blind randomized clinical trial of Salsalate therapy in     obese Hispanic young adults. Salsalate treatment shows promise for decreasing inflammation     under conditions of weight stability by reducing macrophage infiltration of adipocytes.     Hispanics have the greatest amount of visceral adipose tissue (VAT), liver fat, and     inflammation when compared to other ethnic groups, thereby increasing the potential for     treatment effects in this high-risk population.      Purpose: The purpose of this study is to demonstrate through a proof-of-concept trial that     Salsalate induced reductions in adipose tissue inflammation are possible under conditions of     weight stability.      Methodology: We will recruit obese Hispanic young adults (18 - 35 years) from hospitals,     clinics, and community centers. Study Endpoints: Primary outcomes will be macrophage     infiltration as assessed by the presence of crown-like structures (CLS) in subcutaneous     adipose tissue (SAT) biopsies, liver fat, insulin sensitivity, and fasting glucose. We will     also assess plasma levels of monocyte chemoattractant protein (MCP)-1, tumor necrosis factor     (TNF)-α, interleukin (IL)-1, C-reactive protein (CRP), and SAT gene expression of nuclear     factor kB (NF-kB) and insulin signaling pathways.      Intervention and Follow-up: Participants will be randomly assigned to four weeks of treatment     with Salsalate (4 g/d) or placebo and will be studied under weight maintenance conditions.     These measures will enable us to determine if Salsalate treatment is capable of reducing     adipose tissue inflammation and related metabolic outcomes in the absence of weight loss.   "
88260|NCT02130791|"     Insufficient sleep is common, affecting 20-40% of adults, and resulting from sleep disorders,     medical conditions, work demands, stress/emotional distress, and social/domestic     responsibilities. It produces significant social, financial and health-related costs, and it     has increasingly become a major public health concern as population studies worldwide have     found that reduced sleep duration is associated with increased risks of obesity, morbidity,     and mortality. It is well established that sleep loss causes fatigue and sleepiness, as well     as errors and accidents that are due to its adverse neurobehavioral effects on alertness,     mood, and cognitive functions. However, there are substantial, trait-like differences among     people in the extent to which they experience such neurobehavioral deficits when sleep     deprived. Common genetic variations involved in sleep-wake, circadian, and cognitive     regulation may underlie these large inter-individual differences in neurobehavioral     vulnerability to sleep deprivation, though it remains unclear whether different types of     sleep deprivation involve the same phenotypic responses and same genotypic contributors. This     project will be the first large-scale investigation of markers of differential cognitive     vulnerability to both acute total sleep loss and chronic partial sleep loss. It will identify     individuals who are at significant risk for fatigue and severe impairments from sleep loss. A     total of 110 healthy adults will undergo a 13-day laboratory protocol to thoroughly     characterize their cognitive, psychological and physiological responses to two of the most     common forms of sleep loss--acute total sleep deprivation (1 night of sleep loss) and chronic     partial sleep deprivation (5 nights of sleep limited to 4 hr). The findings from this study     will represent a critical first step toward tailoring appropriate follow-up interventions for     sleep loss and its symptomatic relief by finding predictors of at-risk individuals who should     avoid sleep loss whenever possible, and/or seek effective countermeasures. Whether or not     markers of neurobehavioral vulnerability to sleep loss are identified, the results of the     project will help inform public policies pertaining to the need for adequate sleep and for     countermeasures for sleep loss, and also will further our understanding and management of     vulnerability to excessive sleepiness due to common sleep and medical disorders.   "
88261|NCT02130778|"     Adipose and diabetic patients have glomerular hyperfiltration and enhanced reabsorption of     sodium in the kidney leading to fluid retention and hypertension. It is already known that     obese mice (db/db) have salt retention and elevated intrarenal angiotensin II , and that the     mechanism of the salt retention is similar to the one described in human beings. In     experimental study from 2009 done by Hirata K and al., published in Biochemical and     Biophysical Research Communications to both obese type 2 diabetic db/db mice and non-diabetic     db/m mice hypertension was artificially induced (acute sodium-loading and angiotensin     II-infusion). Two groups of mice were treated with exendin-4 or vehicle for 12 weeks. Obese     type 2 diabetic db/db mice show high salt-sensitivity. Exendin-4 demonstrated     anti-hypertensive effect in db/db mice and angiotensin II-infused mice, related to     attenuation of high salt-sensitivity. That observation confirmed that exendin-4, a GLP-1     (Glucagon-like peptide-1) analogue, has extra-islet effect including the regulation of salt     handling. More then ten years before mentioned observations the presence of GLP 1 receptors     was confirmed all over the body, also in kidneys. In 2004 Gutzwiller published a study in     Journal of Clinical Endocrinology and Metabolism that examined 15 healthy subjects and 16     obese men (mean body mass index, 36 kg/m2) in a double-blind, placebo-controlled, crossover     study. After overnight fasting hypertonic saline was infuse followed by 3-h infusion of     GLP-1. Intravenous infusions of GLP-1 enhanced sodium excretion, reduced H+ secretion, and     reduced glomerular hyperfiltration in obese men. These findings suggest an action at the     proximal renal tubule and a potential renoprotective effect. Two years later same author with     colleagues published a new study in Digestion. In a part of new study he observed 8     volunteers. The protocol included intravenous salt load compared to the effect of an infusion     of GLP-to isotonic saline (placebo). Extracellular volume expansion induced by an intravenous     infusion of hypertonic saline was partially compensated by an increase in urinary sodium and     water excretion with GLP-1. He explained that volume expansion was associated with increased     renal perfusion, rise in glomerular filtration and the filtered sodium load. It was observed     that GLP-1 is able to increase renal sodium excretion by 69% and urine volume by 86%.     Considering all mentioned above it is obvious that GLP-1 have natriuretic effect, although     its exact mechanism and clinical usefulness remain unclear. Both GLP1 analogues and     inhibitors of DPP4 (dipeptidyl peptidase 4), elevate GLP1 level, and it would not be a     surprise to observe similar natriuretic effects in the body. Since GLP 1 is a peptide given     IV. or sc. there are on long-term studies that observe final possible effect no blood     pressure, but GLP1 analogues and DPP4 inhibitors enhancing the incretin action demonstrate     some antihypertensive properties. 2008 in a study done by Mistry GC and al., published in     Journal of Clinical Pharmacology antihypertensive effect of sitagliptin was observed. In     nineteen patients on stable treatment with antihypertensive agent(s) investigators found     small but statistically significant reductions of 24-hour ambulatory blood pressure. There     are no many definitive clues why the blood pressure should droop during any treatment that     elevates serum GLP1. At the end of 2009 an analysis was published in American Journal of     Hypertension, showing results from six trials including 2,171 subjects treated with exenatide     for at least 6. Again, a significantly greater reduction in systolic blood pressure was     confirmed, not giving an explanation why it happened so. Finally, Prof. Sjöholm from     Karolinska institute Sweden published in Diabetes, obesity and metabolism a review concerning     impact of GLP-1 on endothelial function. He mentioned again decreased blood pressure through     improvements in diuresis and natriuresis, but he also added a new element, improved     endothelial dysfunction through GLP-1 receptor-dependent pathway. Though there are many     speculations, exact antihypertensive effects and water homeostasis of both GLP-1 itself, also     of GLP1 analogues and DPP4 inhibitors is still unknown. Finally, recent review (Tanaka et     all) from 2011 confirms mentioned speculations regarding natriuretic effect of GLP1, quote …     Incretin mimetics and DPP-IV inhibitors are a novel class of antihypertensive drugs with     natriuretic properties. They can be used in the treatment of salt-sensitive hypertension,     which is characterized by edema. The idea is to investigate the effect of GLP1 on     diuresis/natriuresis compared with placebo in healthy non-obese people and to compare     natriuresis with GLP-1, BNP (brain natriuretic peptide) and ADH (antidiuretic hormone) levels     in serum.   "
88262|NCT02130765|"     To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™     ablation catheter system results in a superior clinical outcome compared to routine drug     therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic     and non-ischemic) while maintaining an acceptable safety profile.   "
88263|NCT02130752|"     Gastric cancer as one of the most common gastrointestinal cancers, radical resection of     primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons     all over the world. By the invented and adopted energy surgical instruments, surgical     procedure is safer and easier than before. The newly surgical instruments reduce the     post-operative mortality and morbidity combined easy procedures of surgery. As the most     popular instruments used in the gastric surgery, ultrasonic scalpel and monopolar     electrocautery were received lots of attention and concern. Some studies have shown some     advantage of the two instruments, which were they can facilitate the surgical treatment and     make the surgery safer and more effective. Although, some small retrospective sample reports     claimed that ultrasonic scalpel brought benefit in blood loss, dissection lymph-node     intraoperative complications and even postoperative complications. And Korea small sample     randomized controlled trail presentation that ultrasonic scalpel can reduced blood loss and     surgical duration. However, postoperative complications were with no statistical significance     between the two instruments. Cost- effective analysis of the energy instruments is still     controversial. Large sample randomized control trail with high quality is needed.      By the reasons above, a multicenter randomized controlled trial conducted by 9 hospitals from     North to South in China aims to compare the clinical characteristics and outcomes, when using     of the ultrasonic scalpel or monopolar electrocautery in traditional open gastrectomy. The     aim of this study is to evaluate the outcomes of ultrasonic scalpel compared with monopolar     electrocautery in D2 distal gastrectomy, include, intraoperative parameters, postoperative     complications, cost data, and post-operative quality of life.   "
88264|NCT02130739|"     This study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural     anesthesia following continuous thoracic epidural analgesia for mastectomy. The incidence was     1.36% and the mechanism of Horner's syndrome was cephalic spread of the local anesthetic.   "
88265|NCT02130726|"     Laparoscopic surgery has been shown to provide important advantages in comparison with open     procedures in the treatment of several malignant diseases, such as less peri-operative blood     loss, faster patient recovery and shorter hospital stay. All while maintaining similar     results with regard to tumour resection margin and oncological survival. In gastric cancer     the role of laparoscopic surgery remains unclear.      Current recommended treatment for gastric cancer consists of radical resection of the     stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker     for radicality of surgery and quality of care. Therefore, It is imperative that a new     surgical technique should be non-inferior with regard to radicality and lymph node yield.      Preliminary studies show promising results for laparoscopic gastrectomy, but the number of     studies is small and due to lower incidence of gastric cancer in the West they are often     underpowered. A prospective randomised clinical trial is indicated in order to establish the     optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.      Results of the STOMACH trial will further aid in determining the optimal surgical technique     in patients with gastric cancer.   "
88356|NCT02129543|"     The investigators are collecting blood samples to learn more about how the body's immune     system recovers after stem cell transplant (SCT). Participants are either previous recipients     of a stem cell transplant, or a donor of stem cells for transplant.   "
88266|NCT02130713|"     Background - bacterial prostatitis (BP) is a common condition accounting responsible for     about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type     II, are less common but is a condition that significantly hampers the quality of life, (QoL)     because not only is it a physical condition but also a psychological distress. Commonly     patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested     by the European Urology guidelines. This approach, although recommended, may not be enough.     Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.      Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study.     All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The     purpose of the study was to evaluate the efficacy of a long lasting therapy with a     fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21     days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100     mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively     antibiotic alone and an association of antibiotic plus supplement.   "
88267|NCT02130700|"     The goal of this clinical study is to determine the safety and efficacy of VT-464, a     lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer     (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive     Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.   "
88268|NCT02130687|"     In this study the investigators will test the hypothesis that dipeptidyl peptidase IV (DPP4)     inhibition attenuates the antihypertensive effect of angiotensin-converting enzyme (ACE)     inhibition but not angiotensin receptor blockade or calcium channel blockade. The     investigators further hypothesize that this effect is mediated by substance P.   "
88269|NCT02130674|"     Severe traumatic brain injury is associated with life-threatening and incapacitating     secondary injury.      Contemporary therapeutic interventions are aimed at preventing and treating secondary damage.     In this context, improved cerebral metabolism is an important target in modern neurointensive     care.      The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide     restores disturbed brain metabolism following severe traumatic brain injury.   "
88270|NCT02130661|"     Rilapladib is a potent and selective inhibitor of lipoprotein associated phospholipase A2     (Lp-PLA2), which was previously under development for the treatment of atherosclerosis and is     currently being developed for the treatment of Alzheimer's disease.      This study is a single-center, open-label, two-part study. The two study parts will run     independently. Subjects dosed in one part of this study will not be permitted to participate     in the other part.      Part A will investigate the pharmacokinetic profile of rilapladib and its metabolites,     SB-664601 and GSK1174379, after single dose and steady state dosing of rilapladib 250     milligram (mg) along with the biliary and urinary elimination pathways of rilapladib 250 mg.     Part B will determine the effect of repeat administration of itraconazole on the PK of a     single oral dose of rilapladib 25 mg.      Healthy male and female subjects, aged 18-65 years, will be recruited for this study. Ten     subjects will be recruited for Part A and 20 subjects will be recruited for Part B.   "
88271|NCT02130648|"     The purprose of this study is to develop and validate an analytical and clinical NIPD test     for cystic fibrosis from maternal blood by analysis circulating free fetal DNA (cff-DNA),     searching for the paternal mutation in families with CFTR compound heterozygosity   "
88272|NCT02130635|"     This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the     safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557     administered as a dry powder in COPD subjects. Pharmacodynamic effects on biomarkers will     also be assessed. This study will have two parts. In Part A, subjects will be randomized to     active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses     of active treatment in an equal ratio. A sufficient number of COPD subjects (male and female     of non-child bearing potential) will be screened to ensure that approximately 30 subjects are     enrolled and at least 20 evaluable subjects are obtained for Part A and approximately 35     subjects will be enrolled for Part B. In both the parts, subjects will receive study     treatment once daily for 14 consecutive days. Placebo control will be included for a valid     evaluation of adverse events attributable to treatment versus those independent of treatment.   "
88273|NCT02130622|"     Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed     gastric emptying will be recruited to participate in the study. Using double-blinded     methodology, study participants will be randomly assigned to one of two treatment arms:     promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days.     The primary outcome will be the change in gastroparesis symptom severity, as measured by the     Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants     will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores,     adverse events and treatment compliance will be assessed. It is hypothesized promethazine     treatment will be superior to placebo in improving symptoms of gastroparesis.   "
88274|NCT02130609|"     The objective of this study is to improve the treatment guidelines for the Elite+ by     determining the maximum safe settings for skin and correlate them to measurement of Melanin     Index (MI) (MI).   "
88275|NCT02130596|"     Obesity occurs at 2-3 times the general population rate in persons living with a psychotic     illness. The risk of obesity-related serious medical conditions like diabetes and heart     disease are also two to three times higher in this population. Traditional behavioral weight     management approaches help more than half of these individuals to lose weight, but a     significant proportion are not helped. This pilot study is intended to determine the     feasibility, efficacy, acceptability, and potential clinical utility of an intervention that     integrates mindfulness, acceptance, distress tolerance, and motivation and commitment     combined with traditional behavioral strategies for weight loss. This is the first study to     investigate such an acceptance-based behavioral intervention for weight loss in psychotic     illness. The results from this study will help to determine whether future research in this     area is warranted with a larger sample, over a longer period of time.      Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance     based behavioral intervention, relative to those who receive nutritional counseling.   "
89012|NCT02120963|"     Aim: To study if a person-centered physical therapy intervention program contributes to     diminished fatigue in people with Rheumatoid Arthritis (RA).   "
88277|NCT02130570|"     The objective of this study is to design and implement a set of procedures (the intervention)     to improve patients' experiences when they are discharged home from the hospital. Second,     this study aims to look at how the intervention affects problems that are known to occur     after discharge, including medication issues, worsening medical problems, or readmission to     the hospital. The investigators will study how well patients recover the ability to do the     things they could before they were admitted to the hospital and their opinions of the     discharge process. Lastly, this study will look to understand the best way to implement the     intervention into different hospitals and practices, and which types of patients benefit from     it most.   "
88278|NCT02130557|"     Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive     bosutinib or imatinib for the duration of the study.   "
88279|NCT02130544|"     Viedo-assisted thoracoscopic surgery(VATS) have became popular in recent years. There is no     golden rule of postoperative analgesia for VATS. Compared with lobectomy, wedge resection     preserves better pulmonary function and is suitable for elder patients and patients who could     not afford to have lobectomy. In addition to surgery time、recovery time and hospital stay,     wound incisions and organization damages are different,too. Will patients also have different     response to pain control after these two surgery? The retrospective study is to compared the     differences of postoperative pain management between VATS lobectomy and wedge resection.   "
88280|NCT02130531|"     The purpose of this study is to characterize emixustat hydrochloride pharmacokinetic and     pharmacodynamic parameters in subjects with geographic atrophy associated with dry     age-related macular degeneration.   "
88281|NCT02130518|"     Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract     infections and blockage caused by crystalline biofilm accumulation (encrustation) of the     catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria     such as Proteus mirabilis, encrustation of the catheter is likely to occur.      The use of a catheter irrigation solution that can prevent biofilm formation and encrustation     leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes,     potentially lower incidence of UTIs and better patient quality of life.      Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits     potential for the rapid decolonization of a range of urologic pathogens, including the     urease-producing Proteus mirabilis.      Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle     solution.   "
88282|NCT02130505|"     In this study, we will investigate both inflammatory systems in healthy volunteers and     patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH)     and familial combined hyperlipidemia (FCH)) during an OGTT.   "
88283|NCT02130492|"     The objectives of this Pilot study are to investigate the toxicity and safety of high doses     of [18F]-Fluorodeoxyglucose (FDG) used as a therapeutic agent in patients with advanced stage     IV malignant tumors that failed standard of care treatment, have a good performance status     and bear radiosensitive tumors with a high [18F]-FDG uptake.      The investigators hypothesize that [18F]FDG may have a significant tumoricidal effect on     cancer cells and radionuclide therapy of cancers with high doses of [18F]FDG administered as     a single dose or in multiple doses (dose fractionation regimen) can be safe and well     tolerated with minimal toxicities. Advantages of FDG are its uptake in many different human     tumors, its short half-life (110 minutes) and the possibility to monitor its effect closely     with the FDG-PET scan. The rationale for using high doses of this radiopharmaceutical agent     for treatement is that most malignant lesions have accentuated glucose metabolism, which is     mirrored by increased uptake of FDG. Since FDG cannot be metabolized within the cell like     glucose, it is effectively confined within the cancer cells; thus, FDG treatment is     potentially a novel form of targeted therapy for tumors with increased FDG uptake.   "
88284|NCT02130479|"     This study aims to address a serious public health problem (i.e., substance abusing     adolescents) by testing the effectiveness of a promising substance abuse treatment     implemented in a community-based treatment setting (CM-FAM, a family-based contingency     management intervention) in comparison to usual treatment services.   "
88286|NCT02130453|"     The goal of this clinical research study is to compare regadenoson nuclear stress testing     with echocardiography strain measurements (an ultrasound imaging method that measures hearts     function) in detecting coronary artery disease.   "
88287|NCT02130440|"     The aim of this study is to evaluate whether treatment with a nasal spray based on     resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or     severe.   "
88689|NCT02125214|"     Temporal dynamics of the EEG microstates show scale-free monofractal properties. This means     that information is encoded in the same way at different scales. It may be postulated that     these monofractal properties of the EEG microstate sequences constitute a necessary     prerequisite of consciousness. We postulate that clinical variations of consciousness may     also be linked to alterations of fractal properties of EEG microstates.   "
88288|NCT02130427|"     This pilot study will determine changes over time in tumor volume/motion & patient anatomy,     as well as dose distributions to normal organs. The study will inform medical decision-making     about need for (and timing of) re-calibration of radiation dosimetry plans. Weekly CT and/or     serial MR scans will be employed for those patients receiving 7-8 wks of radiation therapy.     The study will enroll 30 patients in each stratum: Non small cell lung cancer (NSCLC), Head &     Neck, gastrointestinal (GI) and Gynecologic tumor.   "
88289|NCT02130414|"     The aim of this Phase I, single centre, multi stage study is to evaluate the safety,     tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine     capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.   "
88290|NCT02130401|"     This is a pilot study with a single active treatment arm. The study is designed to assess the     efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2     Diabetes. In particular, the primary outcome measure is a reduction in A1c.   "
88291|NCT02130388|"     Sepsis is the body's response to a life-threatening infection. This study will determine if     zinc supplementation is safe to use in patients with severe sepsis or septic shock. This     study will also gather preliminary information to evaluate the impact that zinc has on the     immune system (the body's defense system against infection) and whether zinc can help     monocytes and macrophages (specific types of cells that remove infections from the body) work     more effectively.   "
88294|NCT02130349|"     The IBD South Limburg (IBDSL) project was initially designed as a prospective population     based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and     prospectively followed. As from 2011, the cohort is being scaled up into a population based     biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms     and identifying markers to predict disease course or therapy response.      Every adult IBD patient, diagnosed in and permanently residing in South Limburg (The     Netherlands), is eligible to participate. The population based nature was reached via a     multi-faceted approach; incident cases were prospectively identified through the     participating hospitals, and missed patients were retrospectively identified using the     nationwide histopathology registry. In 2011, over 3500 patients were included, which     represents 93% of the IBD population in South Limburg.      The cohort includes baseline data, such as IBD phenotype, extent, location, behaviour, extra     intestinal manifestations, medication, surgery, comorbidity and demographics. Data has     prospectively been updated through chart review (clinical data), questionnaires (i.e. quality     of life) and linkage to the authority database (vital state, residence). The biobank includes     serum, plasma, DNA, faeces, biopsies and exhaled air.      We welcome new collaborations. Applications for collaboration are first to be approved by our     IBD-SL committee.   "
88295|NCT02130336|"     Background. The prevalence of metabolic syndrome (MetS) has been increasing, and its risk is     positively correlated with age. Due to ageing society in Taiwan, how to treat metabolic     syndrome and decrease the complications is an important health issue. Relatively few studies     have been focusing on the effects of exercise training in patients with MetS with long-term     follow-up. Recently, high-intensity interval training or aerobic interval training (AIT)     consisting of high intensity separated by active recovery has been proposed to be more     effective than isocaloric continuous moderate-intensity exercise (CME) in raising exercise     capacity (VO2max) in some specific patient population.      Purpose. The purposes are to (1) compare the effects of 16-week CME and AIT on reducing the     numbers of metabolic risk factors in patients with MetS and the prevalence.      Hypothesis: 16-week AIT reduces more metabolic risk factors than CME in patients with MetS.      Methods. This study will be a multiple-center trial. One hundred and twenty patients, aged     ≥45 years, with a diagnosis of MetS for each center will be recruited. Subjects will be     randomly assigned to either control, CME, or AIT group after baseline assessments.     Participants in control group will receive usual care and the others in two exercise groups     will undergo 16-week exercise training. All subjects will receive 16-week, 6-month and 1-year     follow-ups including blood test, body composition (body mass index, waist circumference),     pulse wave velocity, and maximal exercise testing. Statistical analysis will be conducted     using SPSS 11.5, p < 0.05 indicating statistical significance. Data will be presented in     mean±standard deviation or number (percentile) with intention-to-treat analysis. Chi-square     test or one-way Analysis of Variance (ANOVA) will be used to compare whether there are     between-group differences at baseline. Two-way repeated measures ANOVA and post-hoc test will     be performed to examine time and group effect if there is interaction effect, otherwise     Bonferroni will be used. The subgroup analysis between MetS and n-MetS after training will be     performed using the same statistical methods.   "
88296|NCT02130323|"     OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to     3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop     electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has     been recognized that these procedures can increase the risks for pre-term labor in women who     still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a     topical immune response modulator, has significant effects on histological regression of CIN     2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may     be preferable offering similar outcomes on histological regression when compared with     excision or ablation while potentially avoiding or reducing the number of surgical procedure     that places them at risk for future pregnancies.   "
88297|NCT02130310|"     The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to     Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based     therapy, containing activated homologous white blood cells prepared from donated healthy     whole blood. A total of 252 patients will be randomized to receive either CureXcell® or     Placebo.   "
88298|NCT02130297|"     The purpose of this study is to evaluate the potential benefits of treating a surgical scar     post excision with an ablative fractionated CO2 laser with the goal of decreasing the     appearance and size of the scar.   "
88299|NCT02130284|"     This study is a multi-center, single arm and in-clinic study to evaluate the safety of the     PLGM System and its algorithm with the Enlite 3 Sensor.   "
88300|NCT02130271|"     The purpose of this study is to see if the spine shows areas of inflammation using a specific     type of imaging (pictures).   "
88301|NCT02130258|"     The investigators hypothesize that there may exist different quantitative sensory profiles     between radicular pain patients who respond and those who do not respond to the standard     therapy of epidural steroid injections (ESI).   "
88303|NCT02130232|"     The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy     diet and physical activity for helping overweight/obese pregnant women to achieve appropriate     gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the     intervention is to help women achieve the lower bound of the GWG range recommended by the     Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese     women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2     in-person counseling sessions and 11 telephone contacts with study dieticians trained in     motivational interviewing techniques. The lifestyle intervention will be compared to usual     medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks     and 32 weeks gestation, within several days of delivery and at 6 months and 12 months     postpartum.   "
88304|NCT02130219|"     The aim of the study is to evaluate accuracy and precision of non-invasive intracranial     pressure measurement device (Vittamed 205) for selected patients compared with cerebrospinal     fluid pressure measured during lumbar puncture   "
88305|NCT02130206|"     The purpose of this research study is to investigate the bacterial composition of plaque and     saliva located in the mouth and associate that with risk factors that cause cavities.   "
88337|NCT02129790|"     Children and adolescents with early-onset bipolar disorder (BD) are at high risk for     intentionally hurting themselves. Although there are therapies in existence for these youths     with BD, they do not address suicide prevention specifically. Mentalization-based therapy for     adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and     adult population with borderline personality disorder. The investigators will modify the     MBT-A treatment procedures for persons with BD who have had a recent period of suicidal     ideation or behavior.   "
88338|NCT02129777|"     The purpose of this study is to establish proof of efficacy for namilumab in moderate to     severe plaque psoriasis, measured as Psoriasis Area and Severity Index (PASI)75 response rate     at Week 12.   "
88306|NCT02130193|"     The aim of this First Time in Patient study is to obtain initial information on the safety,     tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily     administration of danirixin in subjects with symptomatic chronic obstructive pulmonary     disease (COPD) having mild to moderate airflow limitation and are at high risk for future     COPD exacerbations.      The study will be conducted in two parts. Part A will be a two week open label, single arm     study in patients with COPD to obtain pharmacokinetic data and safety information of repeat     dosing of danirixin in the population of interest. Approximately 10 subjects will be enrolled     in Part A of the study. Progression to and dose selection for Part B will occur following     review of the data collected in Part A. Part B will be a 52-week, randomized, double-blind     (sponsor unblind), placebo-controlled on top of standard of care, parallel group study. Part     B will evaluate several clinical efficacy assessments related to exacerbations and     respiratory symptoms. Approximately 100 subjects will be enrolled with a target of 80     subjects completing 52 weeks of danirixin administration.   "
88307|NCT02130180|"     Diabetic ketoacidosis (DKA) is a complication of type 1, or insulin-dependent, diabetes     (T1DM) and is defined by a high blood glucose level (over 200 mg/dL) coupled with severe     acidosis. In this state the body breaks down fat tissue for adequate energy production. This     results in ketone and acid production, and ultimately DKA. Cerebral edema (CE), or brain     swelling, can also occur with severe DKA. Current evaluation for DKA-related CE necessitates     a high index of clinical suspicion and often times such patients receive advanced brain     imaging such as computed tomography (CT) scans.Ocular sonography (ultrasound) is an     alternative imaging technique that can provide immediate diagnostic capability at the bedside     and minimize radiation exposure. This technique has been used to rapidly and accurately     detect increased brain swelling through measurement of the optic nerve sheath diameter (ONSD)     in a number of clinical situations including pediatric head trauma, hydrocephalus and     ventriculoperitoneal shunt malfunctions, and altitude sickness in adults. Investigators plan     to conduct a prospective study including children aged 7-18 years. The objective of this     study is to assess the utility of sonographic measurements of the ONSD as a tool for     identification of DKA-related CE.   "
88308|NCT02130167|"     Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the     higher risk of high myopia in later life and complications such as retinal detachment and     maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the     effect on retarding the myopia progression. Recently the 0.01% atropine was also reported     effective and with less visual side effects such as mydriasis. The aim of this study is to     compare the efficacy in controlling myopia progression and visual side effects of 2 low     concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least     -0.5 diopters (D) and astigmatism of -1.50 D or less.   "
88309|NCT02130154|"     In this study the investigators aim to investigate whether the sympathetic stimulation of     BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed     tomography computed tomography scan, differs between young and elderly subjects, as an     explanation for the diminished metabolic brown adipose tissue activity in the elderly.      The investigators hypothesis is that sympathetic nervous system activity in the elderly is     diminished as compared to their younger counterparts as an explanation for the diminished     metabolic brown adipose tissue activity in the elderly.   "
88310|NCT02130141|"     The evidence linking chocolate with lowered blood pressure has been observed. However, the     interventions have been short, at most 4 weeks. The aim of this study is to find out if the     habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also,     more insight to the mechanisms linking chocolate to individual healt-responses is needed.   "
88311|NCT02130128|"     The purpose of this study is to evaluate the safety and performance of the LungPoint ATV     System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious     lung cancer.   "
88312|NCT02130115|"     The purpose of this study is to evaluate the safety and performance of the LungPoint ATV     System.   "
88313|NCT02130102|"     In this research project a module based Ambient Assisted Living solution will be provided to     elderly living in assisted living homes. Those products and services seek to impact quality     of life of the elderly and have positive effects on their environment.   "
88314|NCT02130089|"     The purpose of this project is to understand if more frequent education of dialysis patients     (patients with kidney failure who get their blood cleaned and fluid removed by a machine     instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that     patients gain between dialysis sessions. Patients who usually gain more fluid than is     considered ideal will be recruited for this project. Because all patients gain different     amounts to start, data will be collected for 3 months while the patients receive their usual     amount of dietitian education. Then the patients will receive intensive (2x/month) education     on reducing sodium intake from the dietitian and the same data will be collected to see if     they gain less after the education. After 3 months of intensive education, data will be     collected for one more month to see if patients keep gaining less or if they go back to their     old patterns.   "
88315|NCT02130076|"     Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular events. This     increased risk is thought to be driven by inflammation-induced endothelial dysfunction, an     initial step in atherogenesis. Treatment with TNFalpha inhibitors (TNFi) improve endothelial     function in patients with RA. Discontinuation of TNFi could therefore worsen endothelial     function even in the absence of recurrence of systemic inflammation or reactivation of     arthritis. If stopping TNFi results in worsening of endothelial function this would strongly     suggest a higher cardiovascular risk in association with TNFi-wthdrawal   "
88316|NCT02130063|"     The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to     iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron     preparations are ineffective or cannot be used or where there is a clinical need to deliver     iron rapidly.   "
88317|NCT02130050|"     This three-year project aims to        1. Profile the differentially expressed metabolites in healthy patients with severe          Obstructive sleep apnea (OSA) before and after six-month continuous positive airway          pressure (CPAP) treatment        2. Identify the candidate metabolites involved in biologic pathways attributing to OSA          phenotyping and response to CPAP treatment        3. Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes   "
88318|NCT02130037|"     Background: research show that cognitive behavioral therapy (CBT) is effective inreducing     bulimia nervosa (BN) and binge eating disorder's (BED) symptoms. Today, with the development     of technology there are efforts being made for developinga treatment to these eating     disorders threw the media, most of these attempts are based on the CBT method. The size of     the effect that CBT given threw the internet has on BN and BED is still not entirely clear.     Research presented today are mostly based on treatments that were given threw email or     Skypeor an automatic self- help stage program. These researches show heterogenic results     about the effect it had on eating disorders. In this research we aim to investigate the     effect size that a CBT treatment threw a smartphone application that combines a clinician     online reply and an automatic feedback in addition to astandard ones a week clinic treatment     has on BN and BED symptoms frequency.      Methods: Our aim is to make a research using an application that treats that offers an     automatic and human therapist and dietitian reply threw a similar application that is suited     for them. A selected 40 BN or sub-threshold BN or BED patients, men and women ages 18-60     ,that will turn to the Sheba eating disorder medical center will include the research. Half     of the participants will receive aCBT treatment threw a smartphone application along with     astandardclinical treatment that includes ones a week session with a therapist and ones a     week session with a dietitian and the other half will receive a standardclinic treatment     alone. We will test the eating disorder symptoms using eating disorders questionnaires at the     starting point, at the end of a six months treatment and six months after finishing the     treatment.      Importance: This research will allow testing the need and benefit that a personal and direct     patient- therapist connection has over a standardones a week meeting connection format. In     addition, treating with a web application in the future might have a benefit of saving time     spent on getting to the clinic, will allow to shorten the time of the session in the clinic     and will save cost of the face to face treatment.   "
88319|NCT02130024|"     This study will assess the development of Geographic Atrophy with either ranibizumab or     aflibercept in patients with wet Age related Macular Degeneration.   "
88320|NCT02130011|"     This study will prospectively collect patients undergoing the standard CROSS regimen in the     neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will     focus on the potential geometric differences between the OAR and target volume on the initial     planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a     potential difference in the abdominal part of the planned target volume (PTV) and/or     gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential     tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.   "
88321|NCT02129998|"     The aim of this study is to achieve a more profound understanding of the endocrine alteration     in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore     the optimal progesterone level needed for securing implantation and development of early     pregnancy.      The second part of the project will determine the value of Preimplantation Factor (PIF)     measurement in embryo culture medium as a possible tool for improved embryo selection and the     use of PIF as an early pregnancy serum marker for healthy implantation and embryo     development.      IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.   "
88322|NCT02129985|"     Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic     patients can further improve glycemic control, diabetes remission rate and β-cell function     after the short-term insulin intensive therapy.   "
88323|NCT02129972|"     The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in     adults as in children. The colonoscopy is considered as the gold standard exam for the     diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The     follow-up and financial management of this kind of pathology is very much dependent on the     quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique     which assumes a general sedation, many efforts have been done to develop new less expensive     and less invasive techniques in order to offer alternatives to the classic colon endoscopy.     One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 -     Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique     which has been successfully validated with adults. We hypothesize that the CVC can be used in     children with similar results in terms of efficacy, as is the case for adults.      This prospective simple blind multicenter study, will investigate the diagnostic value of the     CVC compared to the conventional colonoscopy under general sedation for the detection and the     control of colon lesions in children presenting IBD.      If the feasibility and the efficacy of the colon video capsule technique are also proven for     use with children, then this new technique might become a very interesting alternative for     the endoscopic examination of the colon because of being less expensive and less invasive.      Moreover, this technique would be very useful as a means of lesions detection all along the     digestive tract and not limited to the colon only.   "
88324|NCT02129959|"     The aim of this study is to observe the cardiovascular effects of the degree of head-down     angle and pneumoperitoneum during laparoscopic procedure using by the fourth version     Vigileo-Flotrac system.   "
88325|NCT02129946|"     The purpose of this study is to determine if consumption of bagels made with resistant starch     for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.   "
88357|NCT02129530|"     The overall purpose is to assess whether a community social mobilization (CSM) program     focused on young men ages 18-35 years of age changes gender norms in the community. The     secondary purpose is to determine if there is a combined effect of CSM and HPTN 068     (Conditional Cash Transfers) on HIV and HSV-2 incidence. The goal of the mobilization     activities is to engage young men around the issues of gender norms, intimate partner     violence and HIV risk and to encourage them to take action to protect young women and reduce     HIV risk in their communities.   "
88326|NCT02129933|"     To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of     patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there     is a need for better endoscopic visualization and the ability for targeted biopsies. Optical     molecular imaging of neoplasia associated biomarkers could form a promising technique to     accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor     (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal     tissue and has proven to be a valid target for molecular imaging. The University Medical     Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting     humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the     fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered,     it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma     (EAC), enabling early cancer visualization using a newly developed fluorescent NIR     fiber-bundle. This hypothesis will be tested in this pilot intervention study.   "
89628|NCT02112942|"     A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in     healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be     evaluated. Antiviral activity will also be assessed in HCV-infected subjects.   "
88327|NCT02129920|"     Early recurrence of cardioembolic stroke in patients with atrial fibrillation is common,     reaching approximately 6% within 30 days after initial stroke. Therefore, it is preferable to     provide early anticoagulation for cardioembolic stroke. However, early anticoagulation may     increase the risk of hemorrhagic transformation of cerebral infarcts. It is difficult to     decide the timing of initiation for anticoagulant therapy in stroke patients with     non-valvular atrial fibrillation (NVAF). In 2013 the European Heart Rhythm Association     presented the practical guides for oral anticoagulants in NVAF patients, which recommend that     the optimal time to start anticoagulant therapy should be determined according to the stroke     severity. However, this recommendation is principally an experts' opinion and is not suitable     in the clinical practice in Japan.      RELAXED, a multicenter observational study is planned to evaluate the efficacy and safety of     an oral direct activated coagulation factor Xa inhibitor, rivaroxaban, for acute ischemic     stroke patients with NVAF in consideration of the infarct size, timing of initiation for     rivaroxaban medication, and other patient characteristics, and thereby to determine the     optimal timing of the initiation during acute ischemic stroke. The consecutive acute ischemic     stroke / transient ischemic attack (TIA) patients with NVAF who are treated with rivaroxaban     will be enrolled. The infarction size at 0-48 hours after stroke onset will be measured by     the diffusion weighted image (DWI) MRI. The primary efficacy endpoint is recurrent ischemic     stroke within 3 months. The primary safety endpoint is major bleedings within 3 months. The     optimal timing to initiate rivaroxaban during acute ischemic stroke is determined by analysis     of co-relation between primary endpoints and the infarct size / time to initiate rivaroxaban.   "
88328|NCT02129907|"     In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned     for inclusion in this trial. After signing an informed consent a blood sample will be     obtained from each participant before iron treatment. The investigators will measure the     thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient     will go face to face interview and will be asked to answer structured questionnaire which     will include information on demographics, clinical data ( fever, allergies , etc.) and     comorbidities      Two weeks after completing intravenous iron administration additional blood samples will be     taken: thrombin generation will be measured   "
88329|NCT02129894|"     To see if the use of Abdominal Binders improves patients out comes after cesarean delivery   "
88330|NCT02129881|"     A study to assess cell therapy as a treatment to prevent kidney transplant rejection. The     trial will involve purification of naturally occurring regulatory T cells (nTregs) from     living-donor renal transplant recipients. The cells will then be grown in the laboratory and     re‐infused into the patient five days after the kidney transplant. This trial is part of an     international European Union funded consortium aimed at evaluating cellular immunotherapy in     solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced     by nTreg therapy can eventually be used to recude the need for conventional immunosuppression     in transplant recipients.   "
88331|NCT02129868|"     People with type 1 diabetes need regular insulin injections or continuous delivery of insulin     using a pump. Keeping blood sugars in the normal range is known to reduce long term     complications. However, achieving treatment goals can be very difficult due to the risk of     low glucose levels (hypoglycaemia). One solution is to use a system where the amount of     insulin injected closely matches the blood sugar levels on a continuous basis. This can be     achieved by what is known as a closed loop system where a small glucose sensor placed under     the skin communicates with a computer containing an algorithm that drives a subcutaneous     insulin pump. Previous studies conducted under carefully controlled clinical research     facility environment, in Cambridge, United Kingdom, as well as several other centres have     shown that closed-loop glucose control is superior to usual insulin pump therapy. The next     logical step in the development pathway is to test closed loop systems in the home     environment. An essential requirement for conducting closed-loop studies outside clinical     research facility is an automated system where wireless data transmission takes place between     the glucose sensor and insulin pump.      The purpose of the present study is to evaluate the efficacy and safety of automated     overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel system     which has greatest potential for use in the home setting. The study will take place at a     clinical research facility on two occasions, using a standardised protocol. The performance     of the closed-loop system will be evaluated on day 1 of continuous glucose monitoring (CGM)     sensor life as compared to on days 3 to 4 of sensor life. Data and experience gained from     this study will be used for further refinements and development of the system for future home     use.   "
88332|NCT02129855|"     The work will evaluate the metabolic costs for daily activities across the lifespan and     evaluate the influence of having functional impairments.   "
88333|NCT02129842|"     The purpose of this study is to assess whether normal endothelial function in patients with     Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable     clinical outcome and maintaining sinus rhythm following ablation   "
88334|NCT02129829|"     The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the     European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps     required to successfully treat patients with chronic hepatitis B virus infection to prevent     cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B     using a point of care test is feasible and effective. The second is to monitor linkage from     screening into care. The third is to evaluate cheap non-invasive assessments to determine the     need for treatment. The fourth is to determine what proportion of patients meet treatment     eligibility criteria. The fifth step is to establish a treatment cohort which can be used to     measure adherence to therapy and avoidance of HBV related complications. A parallel untreated     cohort will be established to determine whether treatment criteria are relevant in this West     African setting by monitoring for complications of HBV infection.   "
88335|NCT02129816|"     Overactive bladder (OAB) is an enigmatic condition that is treated symptomatically with     anticholinergic drugs (gold standard 2013). In a clinical pilot study was found to be a trend     for a higher reduction of the micturition frequency in the Bryophyllum pinnatum group -     treated with chewing tablets containing 50% of dried BP leaf press juice - than in the     placebo group (n=20, p=0.064) Hypothesis: To test the superior effectivity of Bryophyllum     versus Placebo in the treatment of OAB with the needed number (Purpose 1) and to assess in an     experimental arm the side effects of BP in comparison to the standard drug (Vesicare) in a     clincial trial (Purpose 2).   "
88336|NCT02129803|"     This study is a single center, randomized pilot study to evaluate the clinical effectiveness     of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.   "
89466|NCT02115230|"     It is a randomized prospective controlled study of transcatheter renal denervation in     patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to     evaluate the safety and effectiveness of renal denervation in patients with Heart Failure     With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic     activity.   "
88339|NCT02129764|"     Hyperuricemia is a very common finding in patients with heart failure. It is usually related     to diuretic use and deteriorated renal function. The recently evidence showed that prednisone     and allopurinol may have similar effect on uric acid (UA) lowering in symptomatic heart     failure patients with hyperuricemia, but prednisone may be superior over allopurinol in renal     function improvement. Thus the investigators design this randomized head to head study to     test their hypothesis that prednisone is superior over allopurinol in renal function     improvement despite their similar effect on UA lowering in heart failure patients with     hyperuricemia.   "
88340|NCT02129751|"     Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety   "
88341|NCT02129738|"     The purpose of this study is to investigate and document real life safety and satisfaction of     re-use of urethral catheters for intermittent self catheterization. The study will collect     re-used catheters from included patients and compare those to a control group with regard to     bacterial contamination and mechanical properties. A four week prospective evaluation will     follow where the patients will be given catheters intended for single-use.   "
88342|NCT02129725|"     Our research proposal will determine if PDE-5 inhibition exerts a favorable effect on insulin     signaling pathways in skeletal muscle of subjects with impaired fasting glucose and/or     impaired glucose tolerance.   "
88343|NCT02129712|"     This research will leverage novel pilot research conducted by the investigators to take     important first steps in addressing neurocognitive late effects by intervening early, during     treatment, with a promising computerized cognitive remediation program to prevent the     downward trajectory of neurocognitive function experienced by pediatric brain tumor     survivors. Specifically, we propose to test the feasibility, acceptability, and initial proof     of concept of a neuroplasticity-based adaptive cognitive training program (Cogmed) to train     working memory (WM) and attention in newly diagnosed youth with a brain tumor. Further, we     will test the feasibility of using this intervention in a true prospective design beginning     pre-surgery to examine the effects of this intervention in deflecting the downward trajectory     of cognitive function in children with brain tumors during treatment. We will also use     functional neuroimaging (near infrared spectroscopy - NIRS) to examine the effects of this     program on brain activation in frontal regions that are affected by treatment. Findings from     this pilot study will inform the development of a large multi-site randomized efficacy trial     to test an individualized cognitive training program.      Aim 1. To test the feasibility and acceptability of enrolling youth (7 to 16 years-old) with     newly diagnosed brain tumors at time of diagnosis, following patients for 10 weeks,     delivering the Cogmed computer-based training program in a randomized trial at 10-weeks     post-diagnosis, and following patients to 1 year post-diagnosis.      Aim 2. To test the initial acceptability and efficacy of the Cogmed training program on     cognitive function in newly diagnosed pediatric brain tumor patients.   "
88344|NCT02129699|"     The purpose of this study is to investigate how well the standard treatment (platinum-based     doublet chemotherapy) in combination with denosumab works compared with the standard     treatment alone in patients with a type of lung cancer called non small cell lung cancer     (NSCLC) that has spread to other parts of the body.   "
88345|NCT02129686|"     This study is being done to evaluate the potential benefits of using acupuncture to reduce     symptoms of tingling, burning, numbness and pain in the hands and feet of women with     peripheral neuropathy after completion of chemotherapy for breast cancer.   "
88346|NCT02129673|"     Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy     with topically administration of commercially available latanoprost in patient with glaucoma     and ocular hypertension   "
88347|NCT02129660|"     The purpose of the study is to assess the safety of 2 doses of DRM04B compared to 2 doses of     DRM04 and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied     once daily for 4 weeks followed by a 2-week post-dose period.   "
88348|NCT02129647|"     The purpose of this study is to determine if the study drug, AXITINIB, has any effect on     tumors found in patients with Neurofibromatosis Type 2 (NF2).   "
88358|NCT02129517|"     This pilot, randomized clinical trial studies a web-based tailored educational program in     improving nurse communication with patients about clinical trial treatment options. A     web-based tailored educational program may empower and prepare nurses to discuss clinical     trial treatment options with patients and may also increase patient participation in clinical     trials.   "
88484|NCT02127879|"     The main purpose of this study is to determine whether intensive repetitive transcranial     magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in     schizophrenia patients and whether it has a positive influence on their cognitive functions,     social functions, quality of life, alpha frequency and cortical silent period changes. Also,     this study should provide data about safety and tolerability this I-rTMS treatment in     schizophrenia patients.   "
88349|NCT02129634|"     Background      - In patients with critical limb ischaemia (CLI), the infragenicular arteries are often     involved. Without revascularisation, amputation often is imperative. There is a high     technical success rate of endovascular revascularisation of infragenicular arteries with     percutaneous transluminal angioplasty (PTA), but mid- and long-term results are disappointing     as restenosis frequently occurs. Drug-eluting balloon (DEB) PTA has been shown to improve     patency rates after PTA of coronary arteries.      Aim        -  To study the results of DEB-PTA compared to conventional balloon CB-PTA for the          treatment of infragenicular lesions in patients with CLI.        -  To evaluate cost-effectiveness of DEB-PTA versus CB-PTA in patients with critical limb          ischemia (CLI) by quantifying the incremental cost-effectiveness ratio (ICER).      Hypothesis        -  DEB PTA results in improved patency rates compared to CB-PTA for treatment of          infragenicular arterial lesions in patients with CLI.        -  DEB-PTA is a cost-effective strategy in patients with CLI compared with CB-PTA.      Methodology Multi-center, prospective, randomised parallel-group trial. Patients are eligible     for enrolment if they have CLI and at least one infragenicular lesion with a maximal total     lesion length of 20cm. Randomisation will be performed on a 1:1 ratio to either DEB-PTA or     CB-PTA. Patients will be assessed prior and directly after the intervention, at 3, 6 and 12     months by Rutherford classification, ankle-brachial index, toe pressure and adverse events.     Duplex will be performed at 3 months. Angiography will be performed before and directly after     PTA and at 6 months. Primary end-point will be primary patency of the treated lesions at 6     months on angiography (defined as <50% stenosis, without re-intervention in the interim).     Secondary end-points are limb salvage at 3, 6 and 12 months, primary patency of the treated     lesion on Duplex at 3 months (defined as patency of the treated artery with peak systolic     velocity (PSV) ≤2.0 m/sec), Rutherford classification, minor and major amputation,     infrapopliteal endovascular re-intervention, patency of treated femoropopliteal sites (if     applicable), infrapopliteal surgical bypass, peri-procedural complications and death at 3, 6     and 12 months.      A cost-effectiveness analysis (CEA) from a societal perspective will be performed in parallel     with the randomized clinical trial with a 12-month time horizon.   "
90142|NCT02106169|"     The purpose of the study is to determine whether therapeutic education can improve the     quality of life of the child from 8 to 12 years old suffering of food allergy.      This study also show us if therapeutic education has an effect on the quality of life of     child's family.   "
88350|NCT02129621|"     Aldosterone and its target the mineralocorticoid receptor are implied in development of     cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum     aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or     not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity.     The first candidate biomarker is Neutrophil gelatinase-associated lipocalin (NGAL) or     lipocalin which being measured in blood or in the urine. According to scientific     knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary     samples taken during study.   "
88351|NCT02129608|"     Currently in the United States about 97 million adults are considered obese, accounting for     about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as a     body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the     ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia® Zerona™ 2.0     Laser (which will be used in this study) has been approved by the FDA (K123237) as a     non-invasive dermatological aesthetic treatment which can be used by individuals intending to     reduce circumference of hips, waist, and thighs. Lorcaserin is a selective serotonin 2C     (5-HT(2C)) receptor agonist. The exact mechanism of action is not known, but lorcaserin is     believed to promote satiety and decrease food intake by activating 5-HT(2C) receptors on     anorexigenic pro-opiomelanocortin neurons in the hypothalamus. Lorcaserin was approved by the     FDA on June 2012 for weight management in people with a BMI of > 27 kg/m2 (overweight) when     accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure or in     people with a BMI > 30 kg/m2 (obese). The purpose of this pilot study is to obtain     preliminary data on: 1) effectiveness of the combination of LLLT and lorcaserin for reducing     abdominal subcutaneous fat in overweight/obese individuals; 2) impact of LLLT on inflammatory     biomarkers, blood sugar, and cholesterol.   "
88352|NCT02129595|"     The main objective of the study is to investigate if resveratrol supplementation can improve     overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic     patients.      As a secondary objective the investigators want to investigate whether the improved insulin     sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a     reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants     the investigators want to investigate the effect of resveratrol on glucose uptake in brown     adipose tissue.   "
88353|NCT02129582|"     This phase I trial studies the side effects and best dose of targeted marrow irradiation when     given with fludarabine phosphate and busulfan before donor progenitor cell transplant in     treating patients with hematologic malignancies. Targeted marrow irradiation is a type of     specialized radiation therapy that delivers a high dose of radiation directly to the cancer     cells, which may kill more cancer cells and cause less damage to normal cells. Giving     targeted marrow irradiation and chemotherapy drugs, such as fludarabine phosphate and     busulfan, before a donor progenitor cell transplant may help stop the growth of cancer cells.     It may also stop the patient's immune system from rejecting the donor's progenitor cells.     When the healthy progenitor cells from a donor are infused into the patient they may help the     patient's bone marrow make progenitor cells, red blood cells, white blood cells, and     platelets.   "
88354|NCT02129569|"     This pilot clinical trial studies how well psychoeducational and behavioral strategies work     in reducing distress and anxiety in patients with multiple myeloma and their family     caregivers. Education and walking programs, may be able to reduce distress and anxiety and     improve the well-being and quality of life of patients with multiple myeloma and their family     caregivers. Understanding how different forms of education and support can promote emotional     wellness may help nurse researchers find ways to improve services provided to patients and     family members during cancer treatment.   "
88355|NCT02129556|"     A significant amount of preclinical and correlative clinical data suggest that HER2-positive     breast cancer could be amenable to immune¬therapeutic approaches. The presence of     HER2-overexpression in breast cancers is associated with higher levels of proliferation, high     histologic grade and higher levels of tumor infiltrating lymphocytes (TILs) compared with     HER2-negative tumors. The investigators therefore hypothesize that for HER2-positive tumors,     avoidance of destruction by the host immune system must be an important mechanism     contributing to tumor growth and progression.      The term immune evasion refers to the ability of the tumor to suppress and change host     anti-tumor immune reactions. The programmed cell death 1 (PD-1) pathway represents a major     immune control switch which may be engaged by tumor cells to overcome active T-cell immune     surveillance. The ligands for PD-1 (PD-L1 and PD-L2) are constitutively expressed or can be     induced in various tumors. High expression of PD-L1 on tumor cells (and to a lesser extent of     PD-L2) has been found to correlate with poor prognosis and survival in various other solid     tumor types. Furthermore, PD-1 has been suggested to regulate tumor-specific T-cell expansion     in patients with malignant melanoma. These observations suggest that the PD-1/PD-L1 pathway     plays a critical role in the tumor immune evasion and could be considered an attractive     target for therapeutic intervention in several solid organ types.      MK-3475 (previously known as SCH 900475) is a potent and highly-selective humanized mAb of     the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its     ligands, PD-L1 and PD-L2. MK-3475 strongly enhances T lymphocyte immune responses in cultured     blood cells from healthy human donors, cancer patients, and primatesMK-3475 also modulates     the level of interleukin-2 (IL-2), tumor necrosis factor alpha (TNFα), interferon gamma     (IFNγ), and other cytokines.      The investigators therefore propose to evaluate if the addition of an immunotherapy can     reverse trastuzumab resistance and improve clinical outcomes in HER2-positive disease. In     this study the investigators will determine if a monoclonal antibody targeted against PD-1, a     T cell negative regulator, can reverse trastuzumab resistance in patients previously     progressing on trastuzumab.   "
88359|NCT02129504|"     Gingival recessions are often successfully treated by coronally advanced flap technique (CAF)     associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic     collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for     root coverage. CAF technique was not developed for use with CM and has shown limited results     when applied to the CM. The aim of this study was to compare and show the benefits of the     extended flap technique (EFT) compared to CAF technique using CM for root coverage.   "
88360|NCT02129491|"     Our aim is to establish multi-center national Egyptian database of information about     cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.   "
88412|NCT02128815|"     Background: Health coaching is defined as health education, promotion and support by a     professional to enhance the well-being of individuals and facilitate the achievement of their     health-related goals. However, health coaching has not been adequately assessed in the     community health care setting in individuals with T2DM. The purpose of this study is to     determine the effect of diabetes health coaching in adults with T2DM in the community health     care setting on clinical outcomes, self-care behaviours and health care utilization.   "
88361|NCT02129478|"     Olanzapine is licensed for use in adults in Canada and in teens in the US with mental     illness. It is also often used for the management of mental illness in children. This study     will describe the feasibility of giving olanzapine plus other usual medications to prevent     chemotherapy induced nausea and vomiting (CINV) to 15 children aged 4 to 18 years.      What has been done already? - In adult cancer patients, olanzapine improved the control of     CINV. None of the adults studied experienced any serious side effects from olanzapine.      What is being studied and how will the study be conducted? - On each day that chemotherapy is     given, olanzapine will be given to 15 children along with their regular medications to     prevent CINV. Investigators will study each child only during one chemotherapy cycle.     Participants' blood sugar, liver function tests (AST and ALT), prolactin and triglyceride     levels, blood pressure, weight, mood and behavior during the time they receive olanzapine     will be evaluated to see if they change. Investigators will record anything serious that     happens while children receive olanzapine. If any child stops olanzapine early or decides to     decrease the dose, the reason will be recorded. Each child and their guardian will record     their nausea severity and the times they vomit or retch on each day they receive chemotherapy     and for 8 days afterwards.      How will the study help? - This study will help investigators decide if it is feasible to     conduct a larger study to find out if olanzapine improves CINV control in children. If most     children are able to take olanzapine as set out in the study without having significant side     effects, then a larger study would be feasible.   "
88362|NCT02129465|"     Analysis of several characteristics of blood from pregnant women with CMV infection according     to maternal-fetal transmission. These include CMV viral load, cytokine profile in response to     in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV antibodies, maternal     DNA polymorphism and microarray of gene expression.   "
88363|NCT02129452|"     The purpose of this study is to evaluate the olfactory neuroepithelium as a biomarker of     Alzheimer disease. The early diagnosis of Alzheimer disease is of importance for obtaining     better response to treatment, but recently reported biomarkers have some limitations.     Olfactory neuroepithelium tissue which is accessible through office-based biopsy without     difficulty is known to reflect brain pathology that confirms the diagnosis of Alzheimer     disease. This study will help in the early detection and treatment of Alzheimer disease.   "
88364|NCT02129439|"     Ulcerative colitis (UC) represents one of the major entities of idiopathic inflammatory bowel     diseases which are defined as chronically relapsing inflammations of the gastrointestinal     tract not due to specific pathogens. It is characterised by a superficial, continuous mucosal     inflammation, which predominantly affects the large intestine. The clinical course is     typically marked by periods of asymptomatic remission punctuated by unpredictable recurrent     attacks. The symptoms of the patients are marked by persistent diarrhoea with severe faecal     urgency and often incontinence, rectal bleeding, abdominal cramping and weight loss.      Uncontrolled activation of mucosal effector T cells has been identified as the main     pathogenic mechanism involved in the initiation and perpetuation of intestinal inflammatory     reactions.      Patients with moderate UC are initially treated with mesalazine, applied both orally and     rectally. If symptoms do not improve, systemic corticosteroids are to be administered.     Patients who do not respond to systemic corticosteroids may become eligible for treatment     with a calcineurin inhibitor or an anti-tumor necrosis factor (TNF)α antibody. Alternatively,     patients may have to undergo major colorectal surgery.      Patients who do not adequately respond to these treatment strategies exhibit serious     drawbacks. Colorectal surgery may result in a severely compromised quality of life.      Therefore, patients with moderate or severe UC may significantly benefit from new therapeutic     alternatives.      The transcription factor GATA-3 is an interesting target for a novel therapeutic strategy in     UC.      GATA-3 is the key regulation factor of Th2-driven immune responses. It is indispensable for     the differentiation and activation of Th2 cells, integrates Th2 signals, and induces Th2     cytokine expression. Results of a recent clinical trial in children showed that GATA-3 is     involved in the pathogenesis of the acute phase of UC.      The investigational product SB012 contains the DNAzyme hgd40 that targets GATA-3. By cleaving     GATA-3 mRNA hgd40 reduces specific cytokine production and thereby reduces key features of     mucosal inflammation.      DNAzymes are completely generated by chemical synthesis, not by use of any living organism     and are therefore not biological drugs.      This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of the     topical formulation SB012 available in a concentration of 7.5mg/ml hgd40 in 30ml PBS once     daily as a ready-for-use enema in patients with active UC.   "
88365|NCT02129426|"     This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are     used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes     to measure the impact each drug has on what happens during and after MRI sedation with     Dexmedetomidine   "
88366|NCT02129413|"     The purpose of this study is to evaluate the safety and performance of the Delta system in     the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) patients.   "
88367|NCT02129400|"     The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level     in blood of healthy volunteers and to determine the efficient time of inhalation.      Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood   "
88368|NCT02129387|"     The purpose of the proposal is to identify new predictors of smoking progression in young     light smokers (YLS: 18-25 years & cpd < 5) using an 18-month longitudinal design and to     relate these predictors of progression to the genetic profile most highly associated with     smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors     will include individual differences (IDs) in EEG, reward sensitivity, attentional     performance, and mood during abstinence and in response to standardized and to self-selected     acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking     history. The associations of a compelling genetic functional variant polymorphism,     rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking     progression and the novel predictors. The study is expected to provide insights into IDs in     mechanisms and predictors that contribute to smoking trajectories in YLS and thereby lead to     targeted pharmacotherapy and behavioral interventions for at-risk YLS.   "
88485|NCT02127866|"     The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate     bromide) on top of Foster which provides the optimal additive bronchodilator effect to     asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled     corticosteroids plus long acting beta2 agonists.   "
88413|NCT02128802|"     Gastric Bypass followed by renal transplantation is superior to medical management followed     by renal transplant for patients with severe obesity and renal failure.   "
88516|NCT02127463|"     This is a Phase II/III,vehicle controlled, double masked, single center study. A single eye     of 60 individuals with mild to moderate non-exudative Age-Related Macular Degeneration (AMD)     will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2     years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for     these patients.      An analysis of the primary and secondary endpoints will be conducted when all subjects have     completed Baseline, 1, 3, 6, 12,18 and 24 months.   "
88369|NCT02129374|"     Lumbar spondylolysis is a relatively common condition that causes severe and perennial back     pain in young populations. Conservative treatment of this condition may be futile, and may     eventually require surgical treatment such as direct repair of pars defect and a segmental     lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment methods     for spondylolysis, direct repair surgery of pars defect has been focused due to its inherited     strengths. Most importantly, fusion surgery caused the affected segment to lose the nature     range of motion and furthermore adjacent segment to be adversely affecting such as adjacent     disc disease or degeneration, while direct repair theoretically could preserve the motion of     the affected segment, which do not cause the adjacent segment problems as being the fusion     surgery, as well as could produce better surgical outcomes with relatively less invasive     technique as compared to fusion surgery. Moreover, previous articles have demonstrated that     the direct repair surgery for spondylolysis of lumbar spine could achieve great functional     and radiological outcomes. However, most of the previous studies was conducted using lower     level designed study such as retrospective and small sample size, thereby prior literature     does not provide clear information on the therapeutic outcome of direct repair for lumbar     spondylolysis, especially for managing spondylolysis of young population.      Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair     surgery for lumbar spondylolysis in young population. To our knowledge, this is the first     report that describes the functional and radiological outcomes of direct repair for     spondylolysis in young populations with prospective cohort study design and relatively large     sample size.   "
88370|NCT02129361|"     This study is investigating one way to improve health and healthy habits after traumatic     brain injury (TBI). The primary goal of this study is to determine if a brief intervention     accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse     during the year following injury. It is hypothesized that an adapted Screening, Education and     Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week     over the year following discharge from inpatient rehabilitation, in comparison to a Screening     and Education Attention Control condition (SEA control).   "
88371|NCT02129348|"     Clinically, many patients with AD show no response or minimal response to antipsychotics for     symptoms of agitation/aggression or psychosis, or they have intolerable side effects on these     medications. Antipsychotics have a wide range of side effects, including the risk of     increased mortality (60-70% higher rate of death on antipsychotic compared to placebo) that     led to an FDA black box warning for patients with dementia; a more recent review and     meta-analysis showed a 54% increased risk of mortality. In addition, some patients show only     partial response to antipsychotics and symptoms persist. For these reasons, the investigators     need to study alternative treatment strategies. Currently, there is no FDA-approved     medication for the treatment of psychosis or agitation in AD.      The investigators innovative project will examine the efficacy and side effects of low dose     lithium treatment of agitation/aggression with or without psychosis in 80 patients with AD in     a randomized, doubleblind, placebo-controlled, 12-week trial (essentially a Phase II trial).     The results will determine the potential for a large-scale clinical trial (Phase III) to     establish the utility of lithium in these patients.   "
88372|NCT02129335|"     Glioblastoma multiforme (GBM) is the most common malignant central nervous system (CNS) tumor     in adulthood with a median survival of 12-16 months. The drastically shorted life expectancy,     intellectual changes and rapid physical decline in those patients are devastating and do     impose a profound chronic stress on patients and their families. There is extensive evidence     that chronic stress can promote cancer growth and progression. In the setting of GBM     patients, three major questions still have to be answered and will be analysed in this study:        1. Is there a prognostic significance of stress in patients with newly diagnosed GBM on          treatment tolerance and (progression free) survival?        2. Can this stress be modulated by other factors, like stress of patients partners and          patients physical activity, a known independent prognostic factor in recurrent glioma          patients?        3. How is the longitudinal course of patients and partners stress and physical condition          over the disease course and do they influence (progression free) survival?      Answers to these questions will help to establish future projects studying non drug     interventions in patients and patients partners to help improving clinical and tumor related     outcome in patients with newly diagnosed GBM.      The investigators hypothesize that chronic stress, specifically measured as a disruption of     the diurnal cortisol rhythmicity, is an independent prognostic factor in patients with GBM.     Furthermore, physical activity of patients and stress level in patients` partners may impact     - as stress-modulating factors- on stress in patients and on their prognosis.      Aiming at identifying stress-related prognostic factors as potential targets for novel     treatment approaches, we propose, in a first step, a prospective multicenter cohort study:     all patients with newly diagnosed GBM and good performance status (KPS ≥ 50%) who undergo     standard treatment with combined radiochemotherapy with temozolomide (RCT) followed by 6     month of cyclic temozolomide, are eligible. In addition, one partner, defined as a close     person living in the same home or close daily contact to the patient, will be asked for     inclusion.   "
88373|NCT02129322|"     The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin     and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver     transplantation   "
88374|NCT02129309|"     The investigators are interested in studying how Pulmonary Hypertension occurs. A substance     called 'apelin', that naturally occurs in the body has been shown to have an important role     in heart disease. Previous studies have shown that it can make blood vessels get wider, and     help blood flow around the body and thus improve the way the heart and lungs work.      The investigators are looking to recruit both healthy and COPD pulmonary hypertension     patients to study 3 types of apelin. The purpose of this study is to help the investigators     understand how Pulmonary Hypertension occurs which may will help with the development of     future treatments.   "
88375|NCT02129296|"     Gastric balloons are an evolving way of reducing weight. There are two types on the market,     up to date. Air filled balloons seem to be more safe, and more tolerable.   "
88376|NCT02129283|"     The purpose of this study is to determine whether end-of-life training of ICU professionals     leads to improvements in ICU care process, teamwork and family satisfaction.   "
88377|NCT02129270|"     The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the     fracture site (Hematoma block) is more effective in terms of pain relieving then injection of     10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of     distal radius fractures.   "
88398|NCT02128997|"     This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed     incisions decreases the risk of wound complications among obese patients after cesarean     section      All patients having a cesarean section in labor or presenting to the triage unit and     requiring a cesarean section will be eligible      Main study intervention: this involves the use of a negative pressure wound vacuum therapy on     a closed incision.   "
88378|NCT02129257|"     The AMALTHEA (Aflibercept MAintenance after first-Line THErapy with FOLFIRI+Aflibercept in     metastatic colorectal cancer patients) trial is an investigator-initiated, single arm,     open-label, phase II study. Patients with histologically proven metastatic colorectal     carcinoma will be treated with a combination of FOLFIRI and aflibercept for 6 months. Both     Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) and mutant (mut) patients     wil be enrolled. In the absence of Progressive Disease (PD) after 6 months of the combination     of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with     aflibercept alone until PD or unacceptable toxicity, investigator's decision or patient's     refusal of further treatment or death, whichever comes first.   "
88379|NCT02129244|"     The researchers of this study are observing the treatment of multi-drug resistant     Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual     TB drugs and needs to be treated with special drugs. The patients need to take these drugs     for up to two years. Certain hospitals have already agreed to participate in this research     project, half of the hospitals will be assigned a nurse case manager and the other half will     not. The researchers are studying the benefits of having a nurse case manager to improve     treatment response for patients with drug resistant TB. The researchers believe that nurse     case management (NCM) in the intervention sites will increase MDR-TB cure and completion     rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized     programmatic management alone, in patients with and without HIV co-infection. To do this, the     researchers will review the medical information collected at the hospital as part of the     patient's treatment after obtaining the patient's permission.   "
88380|NCT02129231|"     Aims: To evaluate the effect of ezetimibe/simvastatin and rosuvastatin on oxidative stress     and mitochondrial function in patients with DPN.      Methods: We performed a randomized, double-blinded, placebo-controlled phase II clinical     trial in adult patients with type 2 Diabetes Mellitus (T2DM) who had Diabetic Polyneuropathy     (DPN) evaluated by composite scores and nerve conduction studies (NCS), HBA1C <12% (108     mmol/mol), previous exclusion of other neuropathies. Ninety-eight persons with T2DM were     allocated 1:1:1 to either placebo, ezetimibe/simvastatin 10/20 mg or rosuvastatin 20 mg for     16 weeks, and healthy controls (not randomized) were included for comparisons. Primary     outcomes were lipid peroxidation (LPO), nitric oxide (NO), and total antioxidant capacity     (TAC); secondary were clinical, NCS and metabolic parameters. Results were expressed as mean     ± standard deviation (SD) or standard error of the mean (SEM), frequencies and percentages.     Non-parametric analysis was used.   "
88381|NCT02129218|"     This pilot clinical trial studies the feasibility of a low glycemic load diet in patients     with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores     on the glycemic index. The glycemic index is a scale that measures how much a certain     carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help     decrease the chance of cancer coming back and improve the survival in patients with colon     cancer.   "
88382|NCT02129205|"     To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients     with advanced solid tumors in order to determine the maximum tolerated dose and select the     recommended Phase 2 dose.   "
88383|NCT02129192|"     To investigate the steady state pharmacokinetics of different formulation of Telmisartan,     Amlodipine, and Hydrochlorothiazide (HCTZ).   "
88384|NCT02129179|"     This study aims to assess the effect of glucagon-like peptide-1 on cardiac output and     transpulmonary gradient in patients undergoing right heart catheterisation for clinical     reasons.   "
88385|NCT02129166|"     This research study is looking at how imatinib affects how dasatinib is absorbed and     eliminated from the body. Both imatinib and dasatinib are in a class of medications called     tyrosine kinase inhibitors (TKI) and they are used to treat certain types of leukemia (cancer     that begins in the white blood cells). Both imatinib and dasatinib have been given safely in     healthy volunteers. In this study investigators will evaluate the pharmacokinetics     interaction between imatinib and dasatinib when they are co-administered. The hypothesis is     that imatinib will increase the blood levels of dasatinib through inhibiting the drug     metabolizing enzyme and efflux transporter that are involved in the dasatinib absorption and     removal. This research will provide important new insight of combination TKI therapy in terms     of transporter- and enzyme- mediated pharmacokinetic interactions. The research results will     also help guide doctors in knowing how much of a tyrosine kinase inhibitor to give safely     while reaching best effect in TKI combination therapy.   "
88386|NCT02129153|"     In this study, we will evaluate the efficacy and sustainability of the Linking Families     Together (LIFT) intervention to improve parental monitoring during the transition from middle     to high school a particularly risky time for students' academic performance and health     behaviors. This study is based in middle schools around Los Angeles County a region with a     high prevalence of teen risky health behaviors.      The aims of our study are:        1. To conduct a randomized trial of the LIFT intervention and examine whether providing          detailed academic information to parents during their child's 7th and 8th grade          increases parental monitoring at the end of the two year intervention and one year          follow up. We will partner with 3-10 middle schools and recruit 500 student-parent          dyads: 250 will be randomized to the intervention arm and 250 to the usual care control          group.        2. To determine whether the LIFT intervention improves students' academic outcomes, as          measured by grades, attendance, and standardized test scores at the end of the two year          intervention and one year follow up.        3. To evaluate whether the LIFT intervention lowers rates of adolescent risky health          behaviors, specifically substance use (alcohol, marijuana, inhalants, and other drugs)          at the end of the two year intervention and one year follow up.   "
88399|NCT02128984|"     The purpose of this study is to determine whether a nutritional supplement is effective in     the treatment of malnutrition in pediatric patients with failure to thrive or cystic     fibrosis.   "
88400|NCT02128971|"     The purpose of this study is to compare the gastrointestinal (GI) tolerability of 5 different     iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and ferric     glycinate) at the same dose (90mg) and placebo.   "
88401|NCT02128958|"     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in     subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1     prior systemic drug therapy for HCC.   "
88387|NCT02129140|"     The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the     repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is     indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently     FDA-approved for implantation to reinforce soft tissues where weakness exists, but the     investigators would like to collect additional follow-up information to continue to assess     the durability of the repair after placement of the hernia mesh. This follow-up would include     the collection of information about complications such as infections and seromas (collections     of fluid around the surgery site), as well as hernia recurrence and quality of life     questionnaires. Patients who qualify to take part in this study have been diagnosed with a     ventral incisional hernia and will have been scheduled for a surgical hernia repair. This     surgery will be an open surgical procedure and reinforcing your tissue with material is     indicated for this type of hernia repair.   "
88388|NCT02129127|"     This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for     percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease.     The study focuses on acute device performance and peri-procedural safety and also seeks to     further characterize the performance of the device.   "
88389|NCT02129114|"     1. Most of dural defects may lead to subcutaneous effusion and Cerebral Spinal Fluid (CSF)          leakage, which may result in infection; besides, direct adhesion of brain tissues with          sub-scalp tissues also increase the risk of epilepsy, in severe cases, dural defect is          considered a life-threatening condition. So, it's important to repair the dura mater for          restoring its full integrity .        2. Dural Repair Patch(ReDura Onlay) manufactured by Guangzhou Medprin Regenerative Medical          Technologies Co., Ltd. As a product made of clinical absorbable polymer materials by          using bionic technology, Dural Repair Patch has highly bionic 3-dimensional structure          which is proved to facilitate migration and growth of regenerative cells, as well as to          accelerate the growth and repairing of regenerative meninges. While the material is          degraded gradually and absorbed by the body, regenerative meningeal tissue is gradually          formed, achieving true reconstruction of the dura mater.        3. To evaluate the safety and effectiveness of Dural Repair Patch in neurosurgical repairs          of dural defects.   "
88390|NCT02129101|"     This phase I/Ib trial studies the side effects and best dose of azacitidine and sonidegib or     decitabine and so see how well they work in treating patients with myeloid malignancies. The     hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation     and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular     proliferation may be associated with mutations in the Hh-ligand cell surface receptor Smo.     Sonidegib binds to the Hh cell surface receptor Smo, which may result in the suppression of     the Hh signaling pathway and the inhibition of cancer cells. Azacitidine and decitabine may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Giving azacitidine together with sonidegib or decitabine may be a safe and successful     treatment for patients with myeloid malignancies.   "
88391|NCT02129088|"     The purpose of this study is to compare the pharmacokinetics (explores what the body does to     the drug), safety and tolerability of esketamine, administered intranasally (administered     through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants.   "
88392|NCT02129075|"     This randomized phase II trial studies how well DEC-205/NY-ESO-1 fusion protein CDX-1401     (CDX-1401) and neoantigen-based melanoma-poly-ICLC vaccine (poly-ICLC) vaccine therapy work     when given with or without recombinant flt3 ligand (CDX-301) in treating patients with stage     IIB-IV melanoma. The cancer vaccine CDX-1401 attaches to a protein that is made in tumor     cells. The vaccine helps the body recognize the tumor to fight the cancer. The CDX-301     vaccine may help the body make more of the tumor fighting cells, known as dendritic cells.     The poly-ICLC vaccine stimulates the immune system and may help these dendritic cells mature     so that they can recognize the tumor. It is not yet known whether CDX-1401 and poly-ICLC will     work better with or without CDX-301 in treating melanoma.   "
88393|NCT02129062|"     This phase II trial studies how well ibrutinib works in treating patients with B-cell acute     lymphoblastic leukemia that has come back after treatment or has not responded to other     treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
88394|NCT02129049|"     This pilot clinical trial studies the feasibility of a telephone-based educational     intervention in improving communication between patients with stage 0-III cancer and their     children. An educational program delivered by telephone may help parents talk with their     school-age child about their cancer.   "
88395|NCT02129036|"     Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40%     of the patients with clear cell carcinoma are diagnosed in the advanced stage. The     investigators studied the response to chemotherapy and survival for either     paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all     stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with     pure, advanced, clear cell ovarian carcinoma were also evaluated.   "
88396|NCT02129023|"     The purpose of this study is to examine whether exergame use can improve user health, in     terms of physical fitness, self-rated mental health and physical health, and favorable     attitude, strong intention, and actual behavior of future exercise. Moreover, this study also     examines whether past exercise moderates the impact of exergame use on user health.   "
88397|NCT02129010|"     Prospective clinical study to investigate the pathogenesis of Terson syndrome and the     prognostic value of the CSF-biomarkers tau-protein and amyloid-β 40 and 42 in patients with     aneurysmatic subarachnoid hemorrhage. Our two hypotheses are as follows:        1. The incidence of Terson syndrome correlates with the initial intracranial opening          pressure (measured with extra ventricular drain)        2. The CSF-biomarkers correlate with the outcome assessed at discharge, 3-, 6- and          12-months postictally using Glasgow-Outcome-Scale-Extended (GOSE) and Euro-Qol-5 as well          as with complications related to aneurysmatic subarachnoid hemorrhage such as cerebral          vasospasm, delayed cerebral ischemia and re-bleed.   "
88460|NCT02128191|"     The purpose of this study is to evaluate the efficacy and safety of no treatment compared     with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study     hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm     infants. (non-inferiority study)   "
88402|NCT02128945|"     The application of positron emission tomography with lymphoproliferative diseases today     provides diagnostic and therapeutic information of major importance , especially in terms of     speed and quality of response to treatment. The radiopharmaceutical used in clinical practice     for this exam is fluorodeoxyglucose 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose     ([18F]-FDG) . However , the uptake of this tracer is not elective in lymphoid tissues , with     a lack of specificity. In addition , the avidity of this tracer is unequal according to the     histological subtype (lack of sensitivity).      To try to improve the results of this clinical exploration of lymphoid malignancies, the     investigators developed a new radiopharmaceutical ( [18F] - fludarabine ). The idea of     transforming the fludarabine radiopharmaceutical is based on the existence of a fluorine atom     in the molecule and the pharmacokinetic characteristics of this drug. The [18F]-Fludarabine     is a new radiopharmaceutical reproducing the same dosage formulation of fludarabine , a drug     used for the treatment of certain types of lymphoproliferative diseases, especially those     where the tumor cells have a low proliferation kinetics . This drug is used in therapy in     particular pharmacokinetic effect for a high affinity for the lymphoid tissue . Preclinical     results on normal and lymphoma xenograft -bearing mice showed a specificity restricted to     lymphoid tissue fixation with [18F]-Fludarabine compared with [18F]-FDG .      Based on these encouraging results , the investigators propose in this work to explore the     Dosimetry and Biodistribution of [18F] - Fludarabine in human lymphoproliferative diseases :     1)A first group of patients with non-Hodgkin's large cell lymphomas in which it already has a     wealth of experience in exploration [18F]-FDG, and 2) a second group of patients with chronic     lymphocytic leukemia, where the results of the exploration [18F]-FDG are considered     disappointing and did not, for this reason, experienced clinical development.   "
88403|NCT02128932|"     This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of     the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide     versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in     insulin-naïve subjects with type 2 diabetes.   "
88404|NCT02128919|"     This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and     psychiatric symptoms in schizophrenic patients who are current smokers or have a history of     regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine     levels, and craving with QSU scale and response to craving slides. Cognition is measured by     MCCB, symptoms are measured by PANSS and hallucination scale.      This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days,     and sham tDCS for 40 seconds on each sham occasion.   "
88405|NCT02128906|"     The goal of this clinical research study is to learn which chemotherapy combination may be     more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC).     The side effects of these combinations will also be studied.      This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent     chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the     combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status     and the presence of ERCC-1 [4F9] in the tumor prior to randomization. The study will evaluate     cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and     chemotherapy combination works best in relationship to how much ERCC-1 [4F9] is expressed in     a tumor.   "
88406|NCT02128893|"     The purpose of this study is to assess the effect of multiple doses of esomeprazole on the     pharmacokinetics of isavuconazole. In addition, safety and tolerability of isavuconazole     alone and in combination with esomeprazole will be assessed   "
88407|NCT02128880|"     The goal of the proposed research is to develop and pilot test a novel Internet intervention     to reduce the risk of Alcohol-exposed pregnancy (AEP). Efficacious interventions to reduce     the risk of AEP have been developed, but are not widely available. In this project, we will     develop a novel Internet intervention to reduce AEP risk by combining the resources of two     research teams focused on primary prevention of Fetal Alcohol Spectrum Disorders (FASD) and     robust Internet interventions, respectively. We will use our evidence-based AEP risk     reduction intervention materials and our existing Internet intervention development platform     to build and pilot test an Internet intervention (Contraception and Alcohol Risk Reduction     Internet Intervention, CARRIII) in a stage 1 behavioral and integrative therapies development     project.      This three year R34 project will develop and program the new Internet intervention, and will     determine the feasibility and preliminary efficacy of the intervention in a pilot RCT. In     this protocol, we will assess the feasibility and preliminary efficacy of CARRIII against a     Patient Education Website condition in a pilot randomized clinical trial (RCT) with     assessments at pre-, post-, and 6 months.The primary hypothesis is that women randomized to     the CARRIII condition will change more in 3 markers of AEP-related outcomes (risky drinking,     ineffective contraception, and AEP risk) than women assigned to the Patient Education website     condition. We will prepare for a future cost effectiveness evaluation in the larger RCT to     follow by pilot testing proposed measures. The pilot RCT will yield effect size estimates for     a subsequent fully powered trial. If the Internet intervention is promising, it should be     tested in a fully powered national trial. The Internet intervention could substantially     increase the options for AEP prevention, and could lead to a reduction in incident FASD.   "
88408|NCT02128867|"     The purpose of this study is to determine whether three airway clearance techniques (     Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate     gastro-esophageal reflux in infants under the age of 1 year.   "
88409|NCT02128854|"     The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural     African American (AA) adults in South Carolina (SC) for assessing the usefulness of     tablet-based resources in good diabetes self-management behaviors, and (2) to test a     tablet-aided intervention for improving diabetes self-management behaviors   "
88410|NCT02128841|"     Objectives      Primary objective:      To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major     complications in patients undergoing a mechanical aortic heart valve replace-ment.      Secondary objectives:      To identify the value of molecular markers suitable for monitoring of anticoagulation     effectiveness of rivaroxaban and its correlation with transcranial Doppler emboli count in     patients undergoing a mechanical aortic heart valve replacement.      Design This is a prospective, open-label phase 2 pilot study with independent evaluation of     all outcomes and a historical control group.      Number of patients 30 in experimental group (patients in the center's registry database serve     as control group).      Main eligibility criteria All patients between 18 and 70 years old receiving a mechanical     aortic valve replacement with a pre-operative left ventricular ejection fraction >/=35%.      Interventions Experimental: Rivaroxaban 20mg p.o., once daily, for six months Historical     control: Phenprocoumon (Marcoumar) p.o., once daily Outcomes      Primary outcome:      Composite outcome of prosthetic thrombus requiring reoperation/intervention, major bleeding,     visceral ischemia, stroke, pulmonary embolism, myocardial infarction or death from any cause     180 days after intervention.      Secondary outcomes:      Each component of the composite outcome plus serious adverse events. Prosthetic thrombus     requiring reoperation/intervention plus non-clinically relevant thrombi will be used as an     additional safety outcome.      Molecular markers suitable for monitoring the effectiveness of rivaroxaban.   "
88411|NCT02128828|"     The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals     with cognitive impairment. The investigators will study the effect of cenicriviroc on     cognition in 24 subjects over a 24 week period.   "
88461|NCT02128178|"     Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high     risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a     consensus does not exist on the most effective prophylactic approach.   "
88414|NCT02128789|"     Technology has been created to help older adults age well in their homes, but adoption and     acceptance have been slow. The researchers are developing a low-cost web-based technology,     called Elder Tree, for older adults and caregivers to address key challenges older adults     face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from     proven falls prevention strategies, and unreliable home services. Elder Tree is being     developed and tested with older adults and caregivers to identify, 1) usability issues such     as font size, navigation and interface (audio, video,text) and 2) content and tailoring     issues such as identifying local resources and events. This study will employ a randomized     longitudinal design comparing a control group to an intervention group over a 12-month     period. Investigators hypothesize that older adults using Elder Tree will experience greater     independence and quality of life when compared to the control group. Investigators will use     quantitative measures to determine how much our intervention improves: quality of life and     health system use. These measures will help us to determine the cost effectiveness of Elder     Tree. Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability     Resource Centers; one urban, one suburban and one rural setting, so to account for     environmental and community differences. The older adult and their caregiver will be     randomized to the same treatment group. Investigators will measure the effect over the 12     month intervention period and a 6 month follow-up period at 18 months.   "
88415|NCT02128776|"     The purpose of this study is to assess whether an enhanced medical home providing     comprehensive care is cost-effective in preventing serious illness (death, pediatric     intensive care admission, or hospital stay >7d) among high-risk chronically ill children.   "
88416|NCT02128763|"     The objective of the DREAM study is to evaluate the effectiveness and safety of     supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry     eye disease.   "
88417|NCT02128750|"     The primary objective of our work is to show that quantification of muscular     microvascularisation evaluated by injection of contrast agent is different between chronic     critical limb ischemia (before revascularization) and after (healing of ischemia) and thus     make the proof of its utility in evaluation of PAD therapeutics.   "
88418|NCT02128737|"     This project continues an innovative line of research on how to optimally use sleep as an     intervention to promote cognitive recovery from, and resistance to, the neurobehavioral risks     posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to affect     at least 20% of adults. It can result from medical conditions and sleep disorders, as well as     work demands, and social or domestic responsibilities. It is associated with significant     clinical morbidity, and directly causes errors and accidents that are due to its adverse     neurobehavioral effects on alertness, mood, and cognitive functions. In seminal experiments     conducted under this grant, we showed that the neurobehavioral effects of chronic sleep     restriction accumulate to severe levels in a few days, without the full awareness of the     affected individuals, and that recovery from chronic sleep restriction requires more sleep     than previously assumed. We also discovered that recovery from chronic sleep was illusory,     because it masked a heightened neurobehavioral vulnerability to even a single post-recovery     night of sleep restriction. The implications of these findings are that apparent recovery     from chronic sleep restriction masks a more severe cognitive response to subsequent sleep     restriction suggesting that there are longer time constants in the brain for neurobehavioral     recovery from chronic sleep restriction. In light of this finding, we now seek to determine     whether additional nights of extended recovery sleep will reduce the heightened vulnerability     induced by prior exposure to sleep restriction. A total of 87 healthy adults (ages 21-50)     will be studied in the laboratory during a 17-night (N=63) and a 19-night (N=24) protocol     evaluating cognitive, psychological and physiological responses to varying recovery days     between two sleep-restriction periods. The results will establish the number of nights of     recovery sleep needed to prevent accelerated deterioration during a subsequent period of     sleep restriction. The findings will advance theoretical understanding of sleep homeostasis     and its relationship to cognitive functions, as well as inform theories of sleep need, and     have substantial implications for sleep biology, for the treatment of clinical disorders that     regularly disrupt sleep, and for managing lifestyle factors that frequently restrict sleep.   "
88419|NCT02128724|"     This study will test whether a drug called BKM120 is a safe and effective treatment when     given to lung cancer patients having radiotherapy treatment. The trial will identify which of     three possible doses of BKM120 is best to give with lung radiotherapy.   "
88420|NCT02128711|"     There is plenty of evidence to suggest that the lung is not uniform. The internal surface     area is 30 times that of skin, and the different bronchioles/bronchi/alveoli differ greatly     in blood perfusion, temperature, oxygen tension, and pH. Also, particularly in the context of     respiratory disease, notable differences are present in the structure of epithelial cells,     cilia, production of mucus, and inflammatory/immune responses. All of these factors are known     to impact the physiology of bacteria, yet, there is very little understanding of how they     impact a) the presence/absence of particular bacterial species throughout the respiratory     tract, or b) the metabolic processes used by these bacteria within the human host     environment. A greater understanding of the relationships between environmental (chemical)     gradients in the lungs of diseased patients (particularly those with cystic fibrosis) and the     microbial communities that are present may lead to novel hypotheses about manipulation of the     respiratory environment for therapeutic benefit. To investigate this further, the     investigators propose to use explanted lung specimens from cystic fibrosis patients to test     the following hypothesis:      Hypothesis: In patients with cystic fibrosis, bacterial community composition, metabolism and     environmental chemistry will vary depending on their spatial location within the airways.   "
88421|NCT02128698|"     The purpose of this study is to determine wether regular physical activity in combination     with protein supplementation after bariatric surgery can reduce the loss of muscle mass and     wether a computer-assisted exercise program is more effective than a usual exercise program     regarding frequency of physical activity, fitness and muscular strength.   "
88422|NCT02128685|"     The aim of this study is to determine whether the dydrogesterone therapy is associated with     reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis     is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women     with threatened miscarriage.   "
88462|NCT02128165|"     The aim of this study is to compare the efficacy of gastric balloon in weight reduction among     two different categories of morbidly obese people.   "
88513|NCT02127502|"     The investigators seek to evaluate a new test for determining presence of infection/sepsis as     compared to non-infection/systemic inflammatory response syndrome among critically ill     patients within the first 24 hours of their being hospitalized in an intensive care unit     (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to     validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2)     existing clinical parameters. The investigators also hope to assess how well a related, new     blood test, SeptID® identifies different types of infection, as compared to cultures and     other lab tests.   "
88423|NCT02128672|"     Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable     back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery     Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority     of SCS over conventional medical therapy to treat patients with FBSS. Another trial has     demonstrated superiority of SCS over repeat surgery in the same patient population. However,     the ability to reliably capture the low back with paresthesia coverage has remained     challenging and elusive despite numerous strategies designed to overcome this limitation.     Strategies that have been introduced but so far with limited success include transverse     multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and     dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to     reliably overcome the long-term problems of paresthesia capture and pain relief of the low     back.      This proposal describes a new spinal stimulation technique designed to improve the likelihood     of low back stimulation by targeting the nerve supply to the two most commonly affected pain     producing structures in the back, the facet joints and the intervertebral disks. The     technique has proven to be feasible in a cadaver model with ease of lead placement at the     desired targets   "
88424|NCT02128659|"     The purpose of this study is to learn if a cervical health literacy program is a practical     and helpful way of improving women's cervical health knowledge and improving cancer screening     behaviors, and ultimately preventing cervical cancer.   "
88425|NCT02128646|"     The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls     post-operative pain in patients undergoing both open and laparoscopic (minimally invasive)     abdominal hernia repair surgery.   "
88426|NCT02128633|"     Aim: To evaluate the effectiveness of a desensitizing gel for topical and home use in the     treatment of dentin hypersensitivity (DH) through a randomized clinical trial, double-blind,     with three parallel treatment. Methods: 126 subjects were divided into three groups: placebo     gel (PG), test gel (TG) (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%)     and sodium fluoride gel (2% FG ). The measurement of DH was performed by a single examiner     blinded by the visual analog scale (VAS) after tactile, thermal and osmotic stimuli in the     Baseline, 7, 15 and 30 days.   "
88427|NCT02128620|"     The objective of this project is to assess the impact of a Game-Based Appointment System on     both, the clinical settings, and on the use of the educational web app www.sjekkdeg.no.      An A/B testing methodology will be used. This methodology consist on the redirection of the     users to two different versions of the website, and therefore allows to assess the     interactivity of the users according to the design of the webpage and determine which one has     a higher impact on the clinical settings, and consequently on prevention of STDs.      For the A/B test we will test the interactivity of two versions of a web page     www.sjekkdeg.no: the A version (control), consisting en the educative web app; and the B     version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment     System.      The Game-Based Appointment System will offer the users the option of booking appointments at     the venereology department at the University Hospital of North Norway. The system will     include an automatic priority appointments function, with three levels of prioritization     (triage): 1) Emergency-appointment: The user should go to the doctor on the same day or the     following day. 2) Haste-appointment: Within 3-4 days; or 3) Routine-appointment: within 2-3     weeks.      The hypotheses of this research project are:        1. The number of visits with the health professionals will be larger in the game-based          appointment group than in the control group.        2. The number of visits to the educative components of www.sjekkdeg.no will increase after          the launch of the Game-Based Appointment System functionality.        3. The number of visits to the educative components of www.sjekkdeg.no will be larger in          the appointment group than in the control group.        4. The time spent per visit to the website will be larger in the appointment group than in          the control group, meaning a higher exposure to health information.        5. The visitors returning rate is larger in the appointment group than in the control          group.   "
88428|NCT02128607|"     Objectives:      Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with     non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional     disability and kinesiophobia.      Design:      A randomized double blinded placebo controlled trial with double arms in accordance with the     CONSORT statement.      Subjects:      Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a     subgroup of them will be included according to specific inclusion criteria tailored for     indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).      Method:      Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be     treated during a single session, and real/sham SNAG will be applied from a sitting position     with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a     validated kinematic spine model will be used and recorded with an opto-electronic device     (BTS-Elite). Pain at rest and during flexion, as well as functional disability and     kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly     evaluated before and after treatment to compare both groups with  Two-Way-ANOVA  statistic     with for factors; time and groups.   "
88429|NCT02128594|"     Men who have sex with men make up a majority of incident HIV infections, however few     effective interventions to prevent HIV transmission among this group exist. African American     men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is     understood about how the role of stigma impacts their linkage and retention to health care     during treatment. Effective strategies for reducing HIV related risk taking are urgently     needed to prevent further spread of the HIV epidemic. The proposed research will test a     behavioral intervention, which can be used during routine public health services, designed to     reduce HIV risks posed by sexual partner selection strategies. The proposed research will     also identify treatment barriers among MSM who test HIV/STI positive. Effective strategies     for reducing social barriers to health care treatment rely on a comprehensive and thorough     investigation into social barriers that affect AAMSM to effectively engage in medical care.     These areas of research will be focused on for the current trial.   "
88430|NCT02128581|"     Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric     bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given     that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and     also that this hormone causes decreased food intake through increased satiation, it is     reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects     of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose     a dose-response study to determine whether the compound has effects in a dose-dependent     fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in     the immediate aftermath of a test meal and the subsequent hours.   "
88486|NCT02127853|"     Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial,     bilateral cataract surgery.   "
88487|NCT02127840|"     The project is aimed to determine the value of synacthen infusion on the results of adrenal     venous sampling in patients examined for primary aldosteronism   "
88431|NCT02128568|"     This research is a continuation of the Youth Readiness Intervention (YRI) randomized clinical     trial by adding additional pre and post intervention data collection upon treatment of the     control group (N=222) with the intervention which was proven effective in the larger trial.     The overall research has investigated whether participation in the YRI intervention will     improve emotional regulation, prosocial attitudes/behavior, social support and daily and     functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which will     involve treatment of the control group with the effective YRI intervention, the investigators     will add an additional measure of self-regulation as observed via DNA methylation in buccal     cells collected via cheek swabs. As before, after the YRI intervention, youth will be offered     a free educational opportunity at the EducAid program in Freetown or in one of its     upline/provincial sites. This stage of the research, as in the treatment with the main group,     will test whether youth enrolled in the YRI psychosocial intervention go on to demonstrate     improved attendance and behavior in a subsidized education program. In the previous phase of     the trial, the investigators did observe significant effects for the YRI intervention and     evidence that the program is indeed effective. For instance, post-intervention, YRI youth     reported greater improvements in emotion regulation (β=0.109, 95%CI 0.026 to 0.191, δ=0.31),     prosocial attitudes/behaviors (β=0.149, 95%CI 0.057 to 0.240, δ=0.38), and social support     (β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls, and greater reductions in functional     impairments (β= -0.175, 95%CI -0.299 to -0.050, δ= -0.35). Differences in symptoms were     non-significant at six-month follow-up for the full sample; moderator analyses showed that,     for individuals in the top quartile of baseline symptoms, YRI youth had greater improvements     in emotion regulation and social support than controls. At eight-month follow-up, teachers     reported that YRI participants were 8.9 times more likely to be in school (28.8% v. 4.7%) and     showed better attendance (β=3.553, 95%CI 0.989 to 6.118, OR=34.93) and academic performance     (β= -0.954, 95%CI -1.807 to -0.102, δ= -1.31).      In this final phase of the trial as the investigators treat the wait list control group, the     investigators will test whether intervention effects observed in self-report data on improved     emotion-regulation are also upheld in biomarker data. Thus, the investigators will now     provide YRI treatment to the wait list control group and employ the use of biomarkers as a     measure of the intervention's effectiveness. The objective of the study will be to assess     whether DNA methylation (collected via cheek swabs of buccal cells) is associated with     changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis     that the YRI is associated with improvements emotion-regulation evidence both in self-report     data on emotion-regulation and in buccal cell DNA methylation. This study will add to the     evidence base for effective, culturally sensitive mental health services for youth and young     adults affected by war and other forms of adversity.   "
88432|NCT02128555|"     The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better     clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle     osteoarthritis, and compare cost-effectiveness of the two treatments   "
88433|NCT02128542|"     This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir     (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans     with compensated cirrhosis and genotype 2 HCV infection.   "
88434|NCT02128529|"     The purpose of this study was to investigate the prevalence of chronic bronchitis in patients     suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to     assess the difference in exacerbation rates in patients suffering from moderate to very     severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.   "
88435|NCT02128516|"     this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an     intermediate profile, rich in leucines and other essential amino acids, can significantly     enhance muscle mass gain during strength training. This study will compare the efficacy of     NUTRALYS® to a reference product. If the results of the study demonstrate a significant     improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be     considered as an alternative to sports nutrition products, to which many people are     intolerant.   "
88436|NCT02128503|"     This study aims to determine the prevalence of HBV infection in patients with IBD and     rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load     and clinical course of IBD patients.   "
88437|NCT02128490|"     The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended     release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80     mg IR, respectively, in gout participants with moderate renal impairment.   "
88438|NCT02128477|"     Increased periodic repolarization dynamics (PRD) indicate increased risk of death in cardiac     patients. This study thoughts to prospectively validate the prognostic value of PRD in     post-infarction patients.   "
88439|NCT02128464|"     Customized cutting block and conventional cutting guide are both effective in improving     accuracy and function of OA knee patients.   "
88440|NCT02128451|"     The use of clonidine as an alternative to epidural opioids offers several potential benefits.     Clonidine does not have respiratory depressant effects, and the incidence of vomiting and     pruritus is less frequent compared with that seen after administration of epidural morphine.      Epidural clonidine have focused on the optimal doses of clonidine to be used, rather than     analyzing the potential advantage of using epidural clonidine versus opioids with respect to     efficacy and incidence of side effects.      Epidural fentanyl has been used effectively as an alternative to morphine and has been shown     to induce fewer complications when compared with epidural morphine. However, the incidence of     vomiting in patients receiving epidural fentanyl still ranges between 28% and 52% depending     on the study population and concentration used. The analgesic and side effects profile of     epidural clonidine compared with epidural fentanyl are unknown.      The primary aim of this randomized double-blind trial is to test the hypothesis that epidural     clonidine decreases the incidence of side effects compared with epidural fentanyl.      Therefore, we compared the hemodynamic effects of the epidural bupivacaine-clonidine-     fentanyl combination with those of epidural bupivacaine- clonidine- meperdine. The secondary     aim of this study was to determine the analgesic efficacy of bupivacaine-clonidine- fentanyl     combination in comparison to bupivacaine- clonidine- meperdine combination.   "
88441|NCT02128438|"     In general , the diagnosis of back pain can be broken into three major categories: Mechanical     ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection     , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders ,     neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by mechanical     factors, it is the other 2% caused by malignancy, infection, visceral diseases and other red     herrings that must be considered most seriously.      The investigators have observed in their practice that lateral pressure on 5th lumbar     vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over     cervicothoracic spines reproduce original low back and leg pain. So the question arises     whether Cervico-thoracic dysfunction is associated with low back pain with or without     radiation to lower extremities?   "
88442|NCT02128425|"     The purpose of the study is to evaluate if the exposure to all the three active cytotoxic     agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional     chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic     colorectal cancer patients.      A second primary aim is to evaluate the response rate, safety and tolerability of the     chemotherapy of FOLFOXIRI regimen in this patient population.      Patients will be randomized to two therapy groups:      Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX   "
88443|NCT02128412|"     Stent placement is now widely accepted to improve the results of angioplasty (an operation to     widen the blood vessel) and decreasing the need for further surgery. Despite their worldwide     acceptance, stent usage is still limited by renarrowing which occurs within the stent     (restenosis) in some patients within the first six months. In addition there still exists a     small risk of heart attacks soon after the stent is placed.      The purpose of this study is to test the safety and tolerability of trying to place the     stents using a different strategy of using low pressure oversized balloon inflations as     opposed to the usual high pressure balloon inflations. This may reduce injury to the artery     and reduce the chance of renarrowing of the stent. In order to ensure this is a safe and     effective way of performing the procedure the investigators intend to use an Intravascular     ultrasound (IVUS) catheter to look from inside the artery at the stents. IVUS has proven to     be the best way of ensuring optimal stent placement.      Primary hypothesis: Stents will be equally well expanded and apposed using a strategy of     oversized stenting at normal inflation pressures ( < 10 atmospheres ) as compared to high     pressure inflation (≥14 atmospheres) as guided by intravascular ultrasound imaging.      Secondary Hypothesis: There will be no difference in acute clinical endpoints (death,     myocardial infarction, urgent revascularisation or stent thrombosis) using a strategy of     oversized stenting at normal inflation pressure as compared to high pressure inflation.      Tertiary Hypothesis: If the above is shown to be true the investigators would hope to expand     the study in order to reveal a decrease in stent restenosis using a strategy of lower     pressure balloon inflations. The investigators will assess the deployment characteristics of     drug eluting versus bare metal stents   "
88444|NCT02128399|"     Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms.     Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria     detection. However, to the investigators knowledge, there is few data to support the concept     that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities.     Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly     recommended in clinics. As the investigators know, antimicrobial overuse, which occurs     commonly in China, induces a severe antibacterial resistance. China's Ministry of Health     (MOH) has established a policy about the antimicrobial stewardship. To date, the     investigators do not have published documentation the effects of this policy on     multidrug-resistant organism (MDRO) in critically ill patients.   "
88445|NCT02128386|"     The purpose of this study is to estimate the proportion of patients with true resistance     among patients referred to the Medical Outpatient Department of the Charité -     Universitätsmedizin Berlin with the diagnosis resistant hypertension. Moreover, data on     medication adherence will be collected based on therapeutic drug monitoring and on the     answers to validated questionnaires. Finally, efficacy, safety and costs of renal sympathetic     denervation will be compared to an intensified drug treatment in an exploratory way.   "
88446|NCT02128373|"     This pilot clinical trial studies the feasibility and effectiveness of a new computer-based     communication intervention in supporting distance caregivers of patients with advanced lung     or brain cancer. Unlike local caregivers, distance caregivers often receive little, if any,     professional support and have limited communication with the oncology team. Using a     computer-based communication intervention to allow distance caregivers the opportunity to     participate in a physician visit, have questions and concerns addressed, and meet members of     the oncology team may help reduce stress.   "
88447|NCT02128360|"     The purpose of this study is to determine whether minimal ovarian stimulation for in vitro     fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos     as well as pregnancy rates will be compared.   "
88448|NCT02128347|"     Home dialysis has many potential benefits compared to in-center hemodialysis including     improved quality of life, reduced hospital admission and reduced cost. However, some patients     perceive that home modalities are associated with increased isolation from the healthcare     system, substandard care or higher risk of catastrophic events. Providing better support for     home dialysis patients may enhance their ability to maintain at home, improve their health     outcomes, increase quality of life and improve satisfaction with care. In other chronic     disease populations a secure, online communication portal between physicians and patients has     proven useful in enhancing care for patients. Thus far, the utility of an online portal     communication system has not been tested in a cohort of home dialysis patients. The     investigators hypothesize that this novel form of communication will improve care and     outcomes for home dialysis patients. Therefore, in a cohort of home dialysis patients, the     purposes of this study are as follows: 1) Does an online patient-portal improve patient     satisfaction with home dialysis care? 2) Does an online patient-portal improve quality of     life? 3) Does an online patient-portal reduce hospitalization and health service utilization?   "
88449|NCT02128334|"     Eligard is a 6-month depot injection formulation that combines the active ingredient     leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The     6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to     reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in     several clinical trials. However, clinical trials are limited by strict patient inclusion and     exclusion criteria. Therefore, the current non-interventional study aimed at investigating     whether the efficacy and tolerability of the 6-month LA depot formulation could also be     confirmed in a broad and heterogeneous patient population encountered in daily clinical     practice in the Russian Federation.      This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of     patients, demographic patient data, diagnosis and diagnostic findings in patients. It will     provide analysis in different subgroups of patients depending on previous hormonal treatment     and anamnesis of disease.   "
88450|NCT02128321|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In     addition, this study will assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of caffeine and possible metabolites after single dose administration.     Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in     combination with caffeine will be assessed.   "
88451|NCT02128308|"     This study aims to investigate the pharmacokinetic characteristics of second-line     anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.   "
88483|NCT02127892|"     This is a pilot clinical trial of hematopoietic stem cell transplantation for patients with a     diagnosis of Severe Combined Immune Deficiency (SCID) who do not have an HLA-matched sibling     donor. The stem cells will be derived from a 1) matched unrelated donor (MUD), 2) unrelated     cord blood donor, or 3) a haplo-identical (parental) donor (in descending order of     preference).Patients will receive a novel conditioning regimen with Busulfan, Fludarabine and     Anti-thymocyte globulin (ATG) followed by an unrelated donor hematopoietic stem cell     transplant (HSCT) with T-cell depletion using the CliniMACS device.   "
88452|NCT02128295|"     This is a randomised trial of two modern single electric breast pumps allocated to mothers     who are exclusively breast feeding their healthy term infants. Mothers will be recruited when     their infants are around a month old, they will be randomised either to use one of two state     of the art modern single electric breast pumps or to act as controls with no breast pump (but     will receive a baby care voucher of similar value). If allocated to a breast pump, mothers     will be asked to take part in a physiological study when their babies are 6 weeks old. In     this test the mothers will be asked to express breast milk for 10 minutes on each breast. The     primary hypothesis is that the total weight of milk produced in a 20 minute period and the     weight of milk produced at 1 minute intervals at age 6 weeks will be greater for mothers     using one of the pumps. A small sample of breast milk (~5ml) will be collected for analysis,     the remaining expressed milk will returned to the mother.      Each month between the age of 3 and 6 months, all the mothers will be asked to complete     online questionnaires about their breast-feeding and the use of their breast pumps (if they     have one). At the end of the six months the mothers will be given a small voucher for a     child-care store as a way of saying 'thank-you' for the inconvenience caused.   "
88453|NCT02128282|"     This study considers the safety and tolerability of increasing doses of CX-4945 in     combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD),     followed by a randomized study that compares antitumor activity in cholangiocarcinoma     patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the     combination MTD with gemcitabine plus cisplatin.   "
88454|NCT02128269|"     The primary purpose of this study was to evaluate the safety and tolerability of intravenous     (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the     following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or     thrombocytopenia.   "
88455|NCT02128256|"     The surgical management of long bone infections is often challenging. Adequate surgical     debridement decreases the bacterial load, removes dead tissues, and gives a chance for the     host immune system and antibiotics to arrest infection. Adequate debridement may leave a     large bony defect. An appropriate management of the dead space is essential to arrest the     disease, and for maintenance of the bone's integrity. The current strategy includes the use     of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the     dead space. The cement are usually removed after 2 to 4 weeks and replaced with a cancellous     graft harvested from the hip of the patient.      CERAMENT™| G is a CE-marked resorbable ceramic bone graft substitute composed by calcium     sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system     and to promote bone healing. The antibiotic gentamicin is included in the ceramic to prevent     colonization of gentamicin-sensible microorganisms in order to protect bone healing.      The aim of this study is to investigate the device absorption and bone in-growth of     CERAMENT™| G in a surgically revised bone infection. In addition, bone healing and infection     non-recurrence will be evaluated during 12 months of follow-up. The investigators expect a     treatment success of >90 % and that a similar bone healing will be obtained as with a     standard two-stage surgical procedure. In addition, the investigators believe that the use of     CERAMENT™| G will be of advantage for the patient as bone healing will be achieved with a     one-stage surgical procedure (in combination with antibiotic therapy), instead of a two-stage     procedure, thus decreasing potential surgery-related complications.   "
88456|NCT02128243|"     The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of     chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in     terms of overall survival.   "
88457|NCT02128230|"     The purpose of this study is to improve the clinical outcomes of research subjects with     high-risk multiple myeloma in the context of the immediately preceding Total therapy 5 trial     2008-02 and Total therapy 3 trials 2003-33 and 2006-66.   "
88458|NCT02128217|"     People who are recently infected with HCV have a great chance of being cured of the infection     when they are treated with a combination of two drugs within the first 6 months of being     infected. This study is being done to see if a combination of two new drugs in one pill can     replace the old drugs to provide a safer, more effective, and better tolerated treatment for     new HCV infection. The names of the new drugs are ledipasvir (LDV) and sofosbuvir (SOF), and     they will replace pegylated-interferon alfa (PEG-IFN, a drug given as a weekly injection     under the skin). The fixed-dose combination of LDV and SOF (LDV/SOF) has been approved by the     Food and Drug Administration (FDA).      This study started with participants in Group 1 receiving SOF in combination with RBV, a drug     also approved by the FDA, for 12 weeks. There were a total of 17 participants in Group 1 and     all completed treatment. All participants were monitored for safety and viral response while     on treatment. After completing treatment, all participants were evaluated for a treatment     response after the end of treatment.      If the treatment response in Group 1 was high enough, the study design allowed for the     possibility to decrease the length of therapy for Group 2 to 8 weeks, using the same     treatment. However, this did not occur. Combined with the fact that a new and more effective     treatment for chronic HCV has been approved since the study started, Group 2 will now receive     8 weeks of LDV/SOF instead of 12 or 8 weeks of SOF with RBV.   "
88459|NCT02128204|"     The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre     study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital     Institutional Review Board. The aim of this post-marketing study is to evaluate the safety     and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds.      The study was estimated to be held half to one year including a 0-2 weeks screening period, a     day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be     obtained before volunteers enter screening period. If the volunteers meet all the criteria,     they will be given a number to replace their name in the study. The participants will be     randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial     folds and control treatment, Hya-Dermis, in the other side of the face. The safety assessment     evaluated any recorded adverse events following the device treatments either by blinded     evaluator or subjects. The effectiveness of the treatment devices will be assessed by using     photographic assessment, nasoalabial folds severity scale, global aesthetic improvement     scale, and pain visual analog scale.   "
89013|NCT02120950|"     To collect data reflecting the efficacy and safety of aflibercept with and without     photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype     of wet age-related macular degeneration   "
88463|NCT02128152|"     The purpose of this study is to assess the safety and effectiveness of the Ekso robotic     exoskeleton in persons affected by a severe stroke.        -  Primary Objectives:             -  To determine if a structured high-dosage exoskeleton training program (EXTP)               results in clinically significant gains in walking recovery in individuals affected               by severe stroke.             -  To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and               severity (non-ambulators vs. limited house-hold ambulators) affects the improvement               in gait speed and overall function following the EXTP training protocol.             -  To determine whether maintenance or further improvement in gait speed can be               achieved by an intensive follow-up program of either a traditional rehabilitation               program (TRP) or extended EXTP.        -  Secondary Objectives:             -  To determine the effect on functional walking endurance as assessed by the 6 minute               walk test and 10 meter walk test, in high-dosage exoskeleton training program               (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient               setting for post stroke individuals.             -  To determine the effect on functional balance, as assessed by the Berg Balance               Scale, Functional Gait Assessment and Five times sit to stand measure as assessed               by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs.               traditional rehabilitation program (TRP) carried in an outpatient setting for post               stroke individuals.             -  To determine the effect on stroke recovery, as assessed by the step counter of task               specific training in high-dosage exoskeleton training program (EXTP) vs.               traditional rehabilitation program (TRP) carried in an outpatient setting   "
88464|NCT02128139|"     Introduction. Comprehensive data on infective endocarditis in developing countries are     scarce.      Objectives: Description of the characteristics (clinical and microbiological) and assessment     of the outcomes of infective endocarditis in low-income countries.      Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged     over 1 year fulfilling the modified Duke criteria for infective endocarditis.      Exclusion criteria: patient included during a previous infective endocarditis episode.      Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access to     antibiotic treatment (modalities and duration), hospital length of stay and reason for     discharge, and cardiac surgery when indicated.      Duration: One year (June 2014- June 2015)   "
88465|NCT02128126|"     The purpose of the study is to assess the safety, tolerability and the HPV-specific immune     responses of different doses of ISA101 vaccine with or without pegylated IFNα as combination     therapy with carboplatin and paclitaxel.      To qualitatively assess the safety profile and the HPV-specific immune responses of ISA101b     vaccine compared to ISA101 at the same dose levels.      To assess the safety and the HPV-specific immune responses of ISA101b vaccine with     carboplatin, paclitaxel with or without bevacizumab.   "
88466|NCT02128113|"     This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408)     ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract     surgery.   "
88467|NCT02128100|"     This study wants to find out how safe and effective the use of Folfirinox combined with     Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.   "
88468|NCT02128087|"     In this project the investigators develop and test a short message service (SMS) intervention     based on the Information Motivation and Behavior skills (IMB) model. Reminding Adolescents To     Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers     social support via weekly text messages. The investigators propose to adapt their previous     successful SMS-intervention to the specific needs of youths and to evaluate the relative     effectiveness of one-way versus two-way text messages (where two-way messages allow youths to     respond to messages and we hypothesize that this may increase perceived social support that     may be important for youth populations). We will also test the effectiveness of SMS messages     over the longer-term (2 years), for which currently no information is available.   "
88469|NCT02128074|"     The objective of this pilot study is to evaluate the efficacy and safety of KRX-0502,     administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5     non-dialysis dependent chronic kidney disease (NDD-CKD).   "
88470|NCT02128061|"     The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous     Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in     patients aged 80 years old or more with not previously treated cluster of differentiation     antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival     (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the     R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The     statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of     the experimental arm, as compared to the reference arm (R-miniCHOP).   "
88471|NCT02128048|"     Tobacco smoke is probably the single most significant source of toxic chemicals that humans     are exposed to. Smoking is associated with a variety of pathological conditions such as     cardiovascular and pulmonary diseases. In addition to the known harmful effects of cigarette     smoking, several epidemiological studies identified tobacco use as a risk factor for     sarcopenia, the loss of skeletal muscle mass and strength with advancing age. Previous     studies examined skeletal muscles of smokers in comparison with muscles of non-smokers and     found structural and metabolic damage in muscles of smokers.      Quitting of smoking is known to be associated with weight gain. A previous study examined the     effects of smoking cessation on body composition of post-menopausal women using dual-energy     x-ray absorptiometry (DEXA). It was found that women who successfully quit smoking for a     period of 16 months have significantly increased their body weight, fat mass, muscle mass and     functional muscle mass in comparison with non-quitters women. For the first time, it was     shown that smoking cessation is associated with an increase of functional muscle mass. Yet,     the effects of quitting of smoking on muscle mass and muscle functional capabilities of     younger subjects remain unclear. Therefore, we aim to investigate the effects of smoking     cessation on muscle mass, muscle function and strength in heavy smoker's subjects. Our     findings may shed light on the beneficial effects of smoking cessation regarding the status     and function of skeletal muscle in heavy smokers and as a possible strategy to prevent or     delay the progression of sarcopenia.      Research hypothesis: Smoking cessation among adult heavy smokers will lead to increase in     skeletal muscle mass and improvement of muscle function and strength compared with continued     smokers.   "
88472|NCT02128035|"     RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary     angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who     will perform the procedure will wear a radiation protection cap in all procedures.      It is hypothesized that routine use of the pelvic lead shield and radiation protection cap     during these procedures will reduce the amount of radiation in which the interventional     cardiologists get exposed.   "
88863|NCT02122900|"     The primary objective of this study is to determine the reasons for balloon aortic     valvuloplasty (BAV) in the current clinical setting and to determine the outcomes of BAV in     patients with aortic stenosis. The ultimate aim is to establish the safety, effectiveness,     and appropriate role of BAV therapy as definitive therapy (palliation) or as a bridge to     surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).   "
88473|NCT02128022|"     Ischaemic heart disease is the most common cause of death in the UK. Glucagon-like peptide-1     (GLP-1) has been demonstrated to protect the heart when it is deprived of blood supply     (ischaemia). The mechanism for this protection is not clear. Similar protection occurs with     ischaemic conditioning of the heart, which is dependent on potassium channel opening.      The investigators intend to establish whether GLP-1 mediated protection shares a similar     mechanistic pathway. In order to do this the investigators will measures pressure--volume     loops generated in the main pumping chamber of the heart at the time of a percutaneous     coronary intervention (stenting). Patients will be allocated to GLP-1 alone, GLP-1 with     glibenclamide (a potassium channel blocking medication approved for human use), saline     control or glibenclamide alone.      The investigators hypothesis is that the effect of GLP-1 will be abrogated by use of     glibenclamide.   "
88474|NCT02128009|"     The miRNA plays an important regulation role in gene expression, and also closely related to     bone metabolism. Previous research found that postmenopausal osteoporosis with kidney Yin     deficiency syndrome (POP) is associated with CLCF1 gene. This project proposed by     bioinformatics prediction CLCF1 targeted regulation of miRNAs, and use the 3 'UTR dual     luciferase report system for target validation, aimed at the miRNA levels to explore     postmenopausal osteoporosis molecular mechanism with kidney Yin deficiency syndrome.   "
88475|NCT02127996|"     Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty     and stenting is performed for people with angina to improve the blood supply to the heart by     placing metal tubes within the artery using balloon inflation. The procedure risks small but     significant damage to the heart muscle downstream of the balloon.      Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut     in response to food. It acts by stimulating the release of insulin. In the heart it acts to     increase glucose uptake into cardiac muscle. GLP−1 can protect the heart and improve heart     muscle performance in people with coronary artery disease in physiological studies. This     study which assesses whether GLP−1 protects the heart during coronary angioplasty and     stenting.      The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will     reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.   "
88476|NCT02127983|"     The intervention consisted of training non-paid informal healthcare providers (such as     store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the     public health system, and raising community awareness. Front line public health personnel and     community leaders were sensitised to support the intervention.   "
88477|NCT02127970|"     To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment     with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in     patients with known or suspected Gram-positive abSSSI (acute bacterial skin and skin     structure infections) at 48 -72 hours after initiation of treatment.   "
88478|NCT02127957|"     The objective of the investigators research program is to determine whether a combined     exercise program (aerobic and resistance) improves abnormal glucose tolerance and diabetes     control in CF patients. This program of exercises to increase strength and muscle endurance,     exercise tolerance, will be assessed in a group of 12 CF patients with impaired glucose     tolerance. The effect of exercise will be compared with a control group of 12 patients also     glucose intolerant but do not participate in structured physical activity program. The     duration of the exercise program will be 12 weeks and several measures (glucose tolerance,     inflammatory profile, lung function, exercise capacity, muscle strength and endurance) will     be conducted pre and post program to assess the program's impact .   "
88479|NCT02127944|"     IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING     HIGH-SENSITIVE TESTS.   "
88480|NCT02127931|"     Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and     provide little information about accessory movements in response to a stimulus.      Tests such as the Conners' Rating Scale require subjective responses from parents and     teachers, making coordination difficult. The computerized Conners' Continuous Performance     Test (CPT) provides objective data in regards to inattention and impulsive patterns of     response. However, it does not provide data regarding accessory movements such as     restlessness, hyperactivity, and other inappropriate movements. If the subject taking the     exam has a reading disorder, it will impair his or her ability to respond accurately and it     will increase response time. The T.O.V.A. is another computer based test used as a diagnostic     aid for ADHD, which uses a microswitch to record responses. It does utilize auditory and     visual stimuli, which removes the reading level limitation. However, it is unable to measure     to measure accessory movements that may be contributing to reaction time and errors of     omission and commission.      Because of these limitations, a new company called CogCubed has created a new game based on     the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are     unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with     one another. CogCubed is providing the data for this study. The game will be played in a 30     minute sessions by subjects aged 18 and over. Subjects recruited to play the game will be     those with ADHD and those without, matched by gender. Those with comorbidities of     developmental delay, mental retardation, psychosis, schizophrenia, bipolar disorder and     substance use disorders will be excluded, as well as any physiological disability that     affects upper limb movement and/or coordination. Informed consent will be obtained from     participant prior to administering the game.      The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo     for which a game was created, which uses auditory and visual stimuli and distracters, the     investigators expect that they will be able to provide a more accurate profile of impulsivity     and inattention. The investigators expect that inattention will have more errors of omission     and less tilt movements than control and impulsivity will be represented as more commission     and greater tilting movements than control.   "
88481|NCT02127918|"     Electrical status epilepticus in sleep (ESES) is a pattern of abnormal discharges in the     electroencephalogram (EEG). Children who have this pattern present seizures and     neuropsychological regression. There are no studies that systematically evaluate the response     of abnormal discharges in the EEG, seizures and neuropsychological regression to different     antiepileptic treatments. Therefore, treatment strategies in ESES are not based on scientific     evidence. High-dose benzodiazepines such as diazepam (valium) have been reported to improve     the severe EEG abnormalities of patients with ESES in the short-term. But the long-term     response of seizures and neuropsychological regression has not been systematically studied.     Clobazam is a benzodiazepine derivative with antiepileptic properties. The pharmacologic     properties of clobazam make of this drug a particularly useful option in ESES: in patients     with ESES the alpha-2 subunit of the GABA receptor is preferentially up-regulated and     clobazam may have a higher affinity for this particular subunit, so investigators expect a     higher effect of this drug on ESES patients than with other benzodiazepines (Loddenkemper et     al, in preparation). The aim of our study is to objectively evaluate the response to clobazam     treatment of neuropsychological deficits, seizures and abnormal discharges in the EEG in     patients with ESES. Clobazam treatment is used in routine clinical practice and investigators     will objectively quantify its effect.      Our working hypothesis is that high-dose clobazam treatment may control the abnormal     epileptiform discharges in the EEG in patients with ESES. The reduction in abnormal     epileptiform discharges may lead to an improvement in neuropsychological deficits and     seizures. The predicted improvement in seizures and neuropsychological function would lead to     a better quality of life in these patients.   "
88482|NCT02127905|"     The protocol is designed for the compassionate treatment of patients with Fanconi Anemia who     do not have an HLA-matched sibling donor. The purpose of this study is to determine the     likelihood of engraftment in Fanconi Anemia patients using total body irradiation (TBI),     cyclophosphamide (CY), fludarabine (FLU) and antithymocyte globulin (ATG) followed by an     unrelated donor hematopoietic cell transplant with T-cell depletion using the CliniMACS     device.   "
88488|NCT02127827|"     Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The     insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can     approximate the insulin release patterns of the normal pancreas. Timely and accurate     knowledge of ambient glucose levels is important for insulin dose adjustments. Typically,     glucose values are measured volitionally, several times a day, using capillary fingerstick     samples. In addition, glucose in the interstitial fluid can be measured automatically and     continuously using implantable glucose oxidase-based sensors. Recent study showed that this     continuous measurement of glucose levels allows for a fully automated closed-loop insulin     replacement therapy which requires an algorithm that receives glucose data, calculates an     appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for     development of a closed-loop insulin replacement system that integrates insulin delivery,     glucose measurement, and control subsystems will present several challenges to biomedical     engineers.   "
88489|NCT02127814|"     The purpose of this study is to find whether Lactobacillus reuteri prevents     antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be     admitted from the University Hospitals Case Medical Center. They will be randomly assigned to     an intervention group receiving L. reuteri or a placebo. Supplementation will occur during     antibiotic treatment and for an additional 7 days after cessation of treatment. Data     collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation,     and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary     data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI     symptoms.   "
88490|NCT02127801|"     The purposes of this study are to assess the efficacy, safety and tolerability of a single     dose of REGN1908-1909 in allergic adult participants, to collect information about how much     REGN1908-1909 is in blood over time and to collect information about how the body reacts to     REGN1908-1909.   "
88491|NCT02127788|"     The purpose of this observational study is to describe the actual conditions of prescription     of micafungin in antifungal prophylaxis in French haematological and onco-haematological     units. The efficacy and the safety outcomes will be described.   "
88492|NCT02127775|"     This study will assess the bioequivalence of lesinurad tablets manufactured at two different     sites.   "
88493|NCT02127762|"     By 2020, it is estimated that 3.7 million Canadians will have diabetes mellitus, with type 2     diabetes (T2DM) accounting for more than 90% of cases. Estimates of the prevalence of     diabetic peripheral neuropathy among adults with T2DM range from 26% to 47%. It increases     with patient age and duration of disease and it can be as high as 60 to 70% in older cohorts.     Diabetic peripheral neuropathy is documented in most studies as numbness, tingling, pain     and/or objective sensory changes. Pain is an early manifestation of neuropathy and may be the     presenting symptom of diabetes. Even the best medications and procedures rarely relieve more     than 30% of the discomfort of chronic painful conditions. Diabetic patients continue to     experience debilitating and disabling pain. Pain affects our ability to work, our ability to     participate in recreational activities, our mood and our relationships. It is     well-established that an interdisciplinary approach is key to the treatment of some types of     chronic pain, but little research has been done on the effectiveness of interdisciplinary     treatments for patients suffering from painful diabetic peripheral neuropathy. The     investigators will evaluate the effectiveness of an interdisciplinary approach combining     medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and     improve quality of life among patients with painful diabetic peripheral neuropathy. The     investigators will also evaluate the impact of the program on psychological distress, pain     cognitions, and biomarkers of stress and glycemic function.   "
88494|NCT02127749|"     The purpose of this study is to determine whether treatment with antibiotics, which harm the     gut flora, causes the immune system to be less effective.   "
88495|NCT02127736|"     The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep     patterns can be conditioned according to learning theory in healthy participants.   "
88496|NCT02127723|"     The most common treatments today for enhancing the shape and size of the buttocks are     transplantation of the patient's own body fat after liposuction and insertion of permanent     implants. Macrolane VRF30 is a gel product based on hyaluronic acid which is a transparent     slow-flowing gel. A similar hyaluronic-acid gel from the same manufacturer, Q-Med AB, has     been used for many years for the treatment of facial wrinkles. By injecting Macrolane gel     into the skin, the shape of the buttocks can be altered and their volume increased.   "
88497|NCT02127710|"     This is an open-label, single-arm, multicentre, global, phase II study designed to evaluate     the efficacy and safety of AZD6094 in patients with papillary renal cell carcinoma (PRCC) who     are treatment naïve or previously treated.      An independent central pathology review of tumour samples will be used to confirm the     diagnosis of PRCC of all patients enrolling. However, locally available pathology results     confirming PRCC will be allowed for timely study entry.   "
88498|NCT02127697|"     The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in     patients with poorly controlled asthma over 52 weeks of treatment.   "
88499|NCT02127684|"     The investigators would like to investigate the efficacy of more frequent treatment with     Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.   "
88500|NCT02127671|"     This study will determine whether a program where a health coach works with participants on     heart healthy behaviors and treatment of risk factors is coordinated with primary care can     reduce overall heart disease risk in people with serious mental illness.   "
88501|NCT02127658|"     In this study, the investigators intend to compare therapies (abscess surgery and hygiene     education compared to abscess surgery and hygiene education followed by decolonization) for     Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to     determine which is the more effective treatment. The investigators focus on patient centered     outcomes as described by the families of MRSA infected patients. Such outcomes are likely to     include quality of life, side effects, and school and work attendance. The hypothesis is that     treatment with decolonization will decrease the rate of SSTI recurrence and improve overall     patient centered outcomes. The rationale is that negative outcomes such as recurrence may be     avoided through the use of readily available prevention strategies, but that it is important     to determine how burdensome those prevention strategies are for patients and families.   "
88502|NCT02127645|"     Objective: Recent randomized and non-randomized studies suggest that neoadjuvant radiotherapy     followed by Transanal Endoscopic Microsurgery (TEM) show comparative results to abdominal     resection in pT2 extraperitoneal cancer. As the risk of lymphnode metastases is significant     already for T1 invasive cancers with submucosa infiltration >1 mm it is our intention to     investigate in both T1sm2-3 and T2 rectal adenocarcinomas the effectiveness of this combined     treatment in a case series comparing results of this pilot study to an historical series of     patients affected by T1-T2 rectal cancer who underwent anterior resection (AR) or total     mesorectal excision (TME) with or without abdomino-perineal resection (APR) with no     neoadjuvant therapy.      If equally effective, TEM offers a further reduction in invasiveness of treatment, which     should correspond to a lower morbidity, mortality and a better quality of life.   "
88503|NCT02127632|"     Endotracheal Tube (ETT) is still preferred for laparoscopic surgeries because of the fear of     pulmonary aspiration and inadequate ventilation. Laryngeal mask Supreme (LM-S) is a single     use device and the presence of a drain tube allows to separate the gastrointestinal and     respiratory tracts. We planned to compare ventilation parameters and gastric distension     scores of with LM-S vs ETT during laparoscopic gynecological surgery.   "
88504|NCT02127619|"     The purpose of this study was to assess the results of a Total Knee prosthesis specifically     intended to enhance functional performance , especially in terms of physical and sports     activity.   "
88505|NCT02127606|"     Extended periods of tilt table standing have been observed to improve spasticity in     individuals with spinal cord injury (SCI). The purpose of this study is to determine the     effect of three sessions of whole body vibration while tilt table standing on spasticity in     individuals with a complete or incomplete SCI above the neurological level of T10.     Participants in this study will undergo whole body vibration while standing on a tilt table     for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days.     Spasticity monitoring will be evaluated prior to and after the intervention with the Modified     Penn Spasm Frequency Scale, an interview to obtain the individual's perception and impression     of the effect of whole body vibration on the performance of activities of daily living,     quality of life, pain scale, and global impression of change.   "
88506|NCT02127593|"     The purpose of this study is to establish the bioequivalence of the hormones norgestimate,     norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets,     formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by     dry process, in healthy women.   "
88507|NCT02127580|"     There is limited experience for the balloon expandable THV (transcatheter heart valve) on the     need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results     of a small case series published by Wendler et. al. to examine hard endpoints such as the     incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a     multicenter registry.      We aim to compare the implantation of balloon expandable transcatheter heart valves with or     without predilation with respect to procedural outcomes (VARC2).   "
88508|NCT02127567|"     Introduction: Inadequate reporting is a frequent cause of waste of research. For example,     essential information for evaluating the risk of bias such as the method of randomization is     lacking in 75% of published randomized controlled trials (RCTs), and over 30% of reports do     not provide sufficient details to allow replication of the treatment evaluated in the trial     in clinical practice. To overcome this issue, the CONSORT statement, an evidence-based,     minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines     have since been updated in 2001 and more recently in 2010. In addition, extensions to the     main CONSORT statement have been developed to give additional guidance for RCTs with specific     designs (eg cluster), data (eg harm), and interventions (eg nonpharmacologic treatments).     Many journals endorse the CONSORT statement. Some journals provide recommendations to authors     to follow the CONSORT guidelines and some editors enforce the use of the CONSORT guidelines     by requesting authors to submit a checklist in either the submission or acceptance stage.     Nevertheless, inadequate reporting remains.      Our objective is to evaluate the impact of the CONSORT based online writing tool on the     completeness of reporting.   "
88509|NCT02127554|"     The aim of this study is to find the most agreeable and in the long term most efficient     treatment for epistaxis.   "
88510|NCT02127541|"     Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only     curative approach is the surgical excision. The preoperative detection remains a challenge. A     non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the     preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R)     imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could     be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron     emission tomography (PET/CT) methodology has not been investigated in patients so far.      Beta cell mass (BCM): The in vivo determination of BCM is currently impossible due to the     lack of a reliable tool. Quantitative assessment of BCM in vivo is of enormous interest for     patients with type 1 (T1D) and type 2 diabetes mellitus (T2D) in order to evaluate     pathophysiological mechanisms of T1D and T2D and potential therapeutical interventions aiming     at the prevention of autoimmune beta cell destruction (i.e. in T1D before clinical diagnosis     or after islets transplantation) or preservation of BCM in T2D. Radionuclide-based     methodology (GLP-1R imaging using) radioligands that directly target beta cells appears     particularly promising.   "
88511|NCT02127528|"     this study aims to verify the adequacy of doses of antibiotics prescribed in clinical     practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit     (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact     of these pharmacodynamic parameters on the clinical and microbiological VAP will be     evaluated.   "
88512|NCT02127515|"     This is a randomized controlled trial in women at risk following combined prenatal screening     for Down Syndrome. Women will be asked about their preferences between NIPT and routine     prenatal diagnosis based on a dedicated questionnaire. Women will then be randomized between     NIPT and standard invasive prenatal diagnosis.   "
88864|NCT02122887|"     The investigators expect an intervention that focuses on actual dialogue and familiarity with     members of the other culture, discussion of empathy, generosity, and kindness, and focus on     adaptive and reciprocal modes of conflict resolution will alter both physiological,     behavioral, and mental response to the pain of the other, increase empathy, and reduce     hostility.   "
88517|NCT02127450|"     The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging     concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production     are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or     proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in     the routine in any laboratory is difficult. it will be useful to standardize them detection     to control the emergence.   "
88518|NCT02127437|"     LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double     blind placebo controlled study. The main objective is to prove that lanreotide, a     somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by     at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among     the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to     start in early 2014.      An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to     60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30     ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by     repeated measures, in the overall population as well as in the two GFR stratus.   "
88519|NCT02127424|"     To reduce late HIV diagnosis that remains common in France, the national health agency has     promoted non-targeted HIV screening in health care settings, including emergency departments     (EDs). In our previous survey, non-targeted nurse-driven HIV screening by rapid tests was     feasible, well-accepted but identified only a few new HIV diagnoses mostly among patients at     high-risk. Our findings, consistent with results from other international groups, suggest     that a targeted strategy could be feasible, efficient and cost-effective with fewer tests     required. However, the feasibility and the efficacy of this strategy remain unknown in     France.      The main aim of the present study is to compare the efficacy of 2 strategies: 1) the     combination of the nurse-driven HIV targeted screening and the current practice     (physician-directed HIV diagnostic testing) versus 2) the current practice alone.      The strategies will be compared during 2 randomly assigned periods (cluster randomization and     cross-over) in 8 EDs of metropolitan Paris.      During targeted period, nurses will offer screening to all patients at EDs, aged 18-64 years     old, identified as high-risk by a self-administered questionnaire, not know to be HIV     positive, not being seen for post-exposure prophylaxis or unstable medical illness, and     accepting to participate by providing an informed consent.      In case of confirmed reactive rapid test result, a follow-up visit with an on-site infectious     disease specialist will be arranged within the following 48 hours.   "
88520|NCT02127411|"     Benzodiazepines (BZD) are the most prescribed psychiatric drugs in Brazil, especially for     women. Although it is recommended that the use of BZD is not greater than four weeks, there     are many cases of prolonged use due to the lack of treatment options for dealing with     complaints of insomnia. Given this, the aim of this project is to evaluate the program     Mindfulness-Based Relapse Prevention (MBRP) for adult women with chronic use of     benzodiazepine (BZD) to induce sleep. Specifically aims to evaluate if the MBRP program, can     reduce the pattern of use and level of dependence of chronic users of BZD under gradual     reduction (tapering) or cessation of the use of BZD. This study will be conducted at the Drug     Dependency Unit (UDED) of the Department of Psychobiology of Federal University of São Paulo.     The study will count with two groups: intervention group (IG) and control group (CG) (that     will stay in the waitlist until the eighth month . The sample will comprise 100 women with     chronic use of BZD as hypnotics, 50 will be randomized in the IG condition and 50 in the CG     condition. Changes will be evaluated on several variables such as cessation and dependence of     BZD, quality of life, sleep, anxiety, depression and sexual satisfaction before and after the     intervention in both groups. The data will be submitted to descriptive and inferential     bivariate and multivariate statistic analyzes. It is hoped that this study create subsidies     for the development of complementary interventions for the management of withdrawal symptoms     in chronic users of BZD.   "
88521|NCT02127398|"     It has been shown that restoration of the normal makeup of the bowel bacterial population is     the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration     of the normal bowel bacterial population is best done by transplanting stool from a healthy     donor. The investigators wish to transplant stool from healthy donors to treat recurrent C.     difficile colitis by incorporating the stool into capsules that are administered by the oral     route.   "
88588|NCT02126527|"     This phase I clinical trial studies the side effects and best dose of auranofin and sirolimus     when given together in treating patients with non-small cell lung cancer. Immunosuppressive     therapy, such as auranofin and sirolimus, may be an effective treatment for non-small cell     lung cancer. Sirolimus may also stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving auranofin and sirolimus may be an effective treatment     for non-small cell lung cancer.   "
88522|NCT02127385|"     Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin     (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti     oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease     oxidative tissue damage. There are 3 differenet genotype of haptoglobin Hp 1-1 Hp 1-2 and Hp     2-2 with different anti oxidant properties and different prevalence ( Hp 1-1, Hp 1-2 and Hp     2-2approximately 16%, 48% and 36% respectively) . we hypotheise that IUGR will be more common     and severe in the Hp 2-2 genotype with the less anti oxidant properties.   "
88523|NCT02127372|"     This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment     of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).      This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation.     Not all subjects enrolled into this phase of the study will receive the same dose. The     purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be     used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.   "
88572|NCT02126735|"     CD36, a protein that facilitates tissue uptake of fat, as a common link between blood fat     concentrations and metabolic disease states such as diabetes mellitus. Genetic variants in     the CD36 gene are more common in African Americans compared to Whites and it may confer     protection against metabolic diseases by altering the amount of fat in the blood.      The purpose of this study is to compare the levels of fat in the blood and to assess     endothelial dysfunction among carriers versus non-carriers of the coding SNP, rs3211938 of     the CD36 gene after a high fat meal challenge   "
88524|NCT02127359|"     Cancers occur when the molecules that control normal cell growth (genes and proteins) are     altered. Changes in the tumor genes and in the genes of normal cells are called     alterations. Many of these alterations can be detected by directly examining cancer cells     in a tumor or circulating in blood. Several alterations that occur repeatedly in certain     types of cancers have already been identified. These discoveries ahve led to the development     of new drugs that target those alterations. More remain to be discovered.      Some of the alterations are found in genes. Genes are composed of DNA letters, which     contain the instructions that tell the cells in our bodies how to grow and work. Genes make     proteins which actually carry out the instructions in our cells.      We would like to use your DNA to look for alterations in the genes in cancer cells and blood     cells using a technology called sequencing. Gene sequencing is a way of reading the DNA to     identify errors in genes that may contribute to the behavior of cells. Some changes in genes     occur only in cancer cells. Others occur in normal cels as well, in the genes that may have     been passed from parent to child. This research study will examine both kinds of genes.      The purpose of this research study is to perform gene sequencing (gene tests) on your cancer     cells (obtained from biopsies or surgery) and normal tissues (usually blood). The results of     the gene tests will be used to try to develop better ways to treat and prevent cancers. We     will also study better ways to communicate the results of these complex gene tests to you and     your doctors, and to help you and your doctors use this information to choose the best paths     for treatment. As part of this work, we may also learn things about the genes in your normal     cells; some of that information will also be shared wtih you and your doctors if you so     choose.      Importantly, this study will use tissue specimens that have already been collected and stored     in the pathology department as part of your clinical care or as part of other research     studies you may be participating in. In this study, gene tests will be performed on material     only after the necessary clinical tests have been performed. In general, no additional     invasive procedures will be required.   "
88525|NCT02127346|"     Objective: The objective was to evaluate whether serum vitamin D and calcium concentrations     are associated with chronic periodontitis in Syrian men Methods: This study designed as     Matched Case-Control Study.200 males will be enrolled in this study and will be divided     into two groups. First group consist of 100 patients suffering from chronic periodontitis and     no systemic diseases. Second group consist of 100 healthy volunteers. Serum vitamin D and     calcium concentrations will be tested. Periodontal indexes include probing depth (PD),     clinical attachment level (CAL), and bleeding on probing (BOP) will be taken. Data will be     collected and analyzed.   "
88526|NCT02127333|"     Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary     disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for     vascular function. For this purpose we measure capillary oxygen concentration and vascular.      Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood     flow and laser doppler perfusion imaging.      We hypothesize that hypoxemia leads to impaired vascular function.   "
88527|NCT02127320|"     The purpose of this study is to investigate the pharmacokinetic drug interactions between     Rosuvastatin and Ezetimibe in Healthy Male Subjects   "
88528|NCT02127307|"     This aim of the study is to investigate the prognostic usefulness of AdreView™ imaging to     identify those subjects with New York Heart Association (NYHA) Class II or III HF who will     die during 60 months of follow-up from the date of administration of AdreView™ in prior     studies MBG311, MBG312, or MBG312C (hereafter included in MBG312).   "
88529|NCT02127294|"     The purpose of the study is to evaluate effectiveness and safety of transcatheter patent     foramen ovale closure for migraine.   "
88530|NCT02127281|"     The purpose of this study is to determine the efficacy of a negative pressure wound therapy     (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for     infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk     patients prevents wound complications and decreases reoperation rates.   "
88531|NCT02127268|"     Cancer-related fatigue (CRF) is a distressing, persistent, subjective sense of physical,     emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment     that is not proportion to recent activity and interferes with usual functioning. Compared     with general fatigue, CRF have the characteristics of long duration and generally cannot     alleviate by rest or sleep, serious impact on the patient's work, study, entertainment and     family life, and thus greatly affect the recovery, self-care ability and life quality of     patients. Many dates showed that 70%~100% of cancer patients experienced cancer-related     fatigue.For cancer-related fatigue there is no good treatment and intervention, in recent     years, many clinical trials are carried out; central nervous stimulant, such as     methylphenidate; acupuncture, aerobic exercise. All those measures may have certain     therapeutic effect for CRF, but don't have exact evidences from massive RCT to confirm.      Thymosin-α1 (T-α1), a synthetic 28-amino acid peptide with multiple biological activities     primarily directed towards immune response enhancement, this drug is used for the treatment     of HBV and hepatitis C virus (HCV) infections, and being developed for the treatment of     non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma.     T-α1 is able to potentiate the action of cytokines and also reduce the hematological toxicity     of cytotoxic drug therapy, such as cyclophosphamide, 5-fluorouracil, dacarbazine.      In this studies, we want to demonstrated that the effectiveness of Thymosin-α1 for     cancer-related fatigue in cancer patients who undergo chemotherapy.   "
88589|NCT02126514|"     This study will be an open-label, non-randomized, absorption, metabolism, and excretion study     to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of     [14C]-AZD3293 and derived metabolites following administration as a single 100-mg (containing     approximately 150 µCi) oral dose (as an oral solution)   "
88590|NCT02126501|"     To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in     premature babies born between 26 and 32 weeks   "
88865|NCT02122874|"     Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas     and improves glycemic profile in diabetic patients   "
88532|NCT02127255|"     This is a randomized, controlled cross-over trial. The hypothesis of this study is that the     differences in manual acupuncture manipulation can impact clinical effect though the     acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical     experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients     receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5     days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints     and methods of needling manipulation, needle retention time). Randomly, half of the patients     will receive treatments from acupuncturist 1 in the first treatment cycle and from     acupuncturist 2 in the second cycle; while the other half will be treated in other way round.     There is a washout period (21 days) between two cycles. The needling manipulation of two     acupuncturists will be measured objectively during treatments. The clinical effect will be     measured by the control of vomiting and nausea during and after chemotherapy treatments.   "
88533|NCT02127242|"     Objective:the purpose of this study is to investigate the     efficacy,feasibility,reliability,and safety of laparoscope combined air-pressure ballistic     lithotripsy in the treatment of patients with bile duct stones.      Methods:We are going to select 60 patients diagnosed with hepatolithiasis who carry on the     treatment in our hospital from April 2014 to April 2015.According to the unified inclusion     and exclusion criteria,the patients are divided into the experimental group and the control     group.The experimental group use the treatment of laparoscope combine with air-pressure     ballistic lithotripsy to treat hepatolithiasis,while the control group treat the patients     with hepatolithiasis with the method of lobectomy and segmental resection of     liver.Contrastive analyzed two group of patients' clinical care effects.      Research hypothesis:according to compare two groups' duration of surgery,blood     loss,postoperative complication rate,hospital stay,the stone clearance rate,,the residual     stone rate,reoperation rate etc.We suppose that the clinical results of the experimental     group are superior to the control group,difference is statistically significant(P<0.05).So we     can draw the conclusion that the method of laparoscope combined air-pressure ballistic     lithotripsy is useful in treatment of patients with hepatolithiasis.   "
88534|NCT02127229|"     The purpose of the study is to determine if endoscopist notification of accessory cost     results in altered resource utilization related to the total cost and number of accessories     used in ERCP.      This study will be a prospective cost--analysis study. Only chart review of PHI removed     records will be used. The only intervention used is that endoscopists will be made aware of     the cost of accessories used in the second phase of the study following each ERCP.      The investigators are in an era of increased medical cost consciousness. Medical education     and post--graduate education incorporates cost savings and appropriate diagnostic test     selection based on expense as one aspects of the decision process. This era now focuses on     what is best for the patient with the understanding that the cost to the patient and cost to     the overall health care system matters. Not only is this apart of postgraduate training but     now being implemented as part of Medicare reimbursement to provide low cost and high quality     care. Incidence of pancreatic and biliary disease is increasing. ERCP is a vital tool for     therapeutic intervention. The costs of these procedures, to both patients and hospitals, have     caused some to question the amount of accessories used as well as the poor reimbursement     provided by Medicare and insurers. Studies have indicated that hospitals actually lose money     with each ERCP used and their use is being limited many times to tertiary care centers.   "
88535|NCT02127216|"     In 2010, 25.8 million people in the US, or 8.3% of the population were reported to have     diabetes. Type 2 diabetes mellitus (T2DM) is especially prevalent among older adults: 26.9%     of people 65 years or older have diabetes with 50% being pre-diabetic. Diabetes is the     leading cause of blindness, kidney disease and lower-limb amputation among older adults, and     is also a major risk factor for cardiovascular disease.      Fortunately, diabetes and its related complications are very amenable to lifestyle changes.     Engagement with healthcare providers can significantly affects behavior and disease     management of practices of individuals as does social engagement. The use of mobile     technology and better engagement with providers and peer support networks may support     diabetes self-care management. Individual patient personality attributes may affect the     success of technology interventions.      In this study, the investigators propose to design and test a motivation psychology-based     smart engagement system (MOSES), which is a software application on a digital tablet device.     The pre-loaded tablets will be provided to adults with T2DM (age 60+ with high glucose). The     software will allow the patients to record diabetes self-care activities (exercise, glucose,     nutrition, medication adherence), pursue goals, support communication between the patient and     a health coach, support communication between peer patients, and visualize health status more     easily by patients and providers. This research program will enroll 88 patients (4     intervention groups of 12 persons each and a 40-person control group) in a 90-day pilot study     to test and refine the design of the application and its effectiveness in supporting care     plan goals.      Primary Aim 1: Design, implement, and optimize a motivation psychology-based smart engagement     system (MOSES) for older adults with diabetes.      Secondary Aim 2: Determine if providing older adult diabetic patients to care managers and     peers via a digital tablet-based software application leads to improved diabetes management     as measured by blood glucose control.      Secondary Aim 3: Refine the personality attributes used to tailor the interaction with the     application.   "
88536|NCT02127203|"     Periodontitis is a chronic inflammatory disease whose etio-pathogencity is not fully     understood yet. Reactive oxygen species (ROS) and reactive nitrogen species (RNS) are     involved in physiological and pathological processes. Nitro-oxidative stress has been     implicated in Periodontitis.      The aim of this study is to assess the levels of ROS and RNS in serum and gingival crevicular     fluid (GCF) samples taken from periodontitis (chronic and aggressive) patients and healthy     controls. Subsequently, correlating these levels with the severity of periodontal disease.      Eighty subjects will be invited to participate in this study. Patients will be allocated into     four groups (20 patients each). The biochemical parameters that will be investigated are     Malondialdehyde (MDA) (using TBRSA assay) as a marker of oxidative stress and (NO- level     using Griess reagent) as a marker of nitrosative stress.   "
88537|NCT02127190|"     This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to     demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various     incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion     vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects     of CXA-10 will be investigated.   "
88538|NCT02127177|"     The increased risk of atherosclerotic morbidity and mortality in patients with obstructive     sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and     systemic inflammation. The relationship regarding obstructive sleep apnea (OSA) and lipidemia     and systemic inflammation is far from conclusion for obesity as a strong confounding factor.   "
89014|NCT02120937|"     Mindfulness group therapy can help children with mood irregularities and family history of     bipolar disorder.   "
88539|NCT02127164|"     Emergent abdominal surgeries have very high rate of wound contamination due to exposure to     bacteria from GI tract. There are several different approaches to wound management in these     patients including wet-to-dry dressing or application vacuum assisted device on the wound.     The investigators propose using the vacuum assisted device with Dakin's solution on patients     undergoing emergency surgery for hollow viscus perforation installed immediately at the end     of operation and remained there for the first 3 postoperative days, followed by delayed     primary closure on postoperative day 4. The investigators believe this technique can achieve     earlier wound closure, decrease patient discomfort, improve cost savings, and potentially     standardize and revolutionize the investigators management of heavily contaminated wounds.   "
88599|NCT02126384|"     The purpose of this study is to determine which B lymphocytes subsets are responsible for the     production of IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides after vaccination     with a 23-valent pneumococcal polysaccharide vaccine.   "
88540|NCT02127151|"     A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With     Retrospective PTEN, MSI and MRE11 Analysis      PTEN= Phosphatase and tensin homolog MSI= Microsatellite instability MRE11= Double-strand     break repair protein MRE11A      This trial will investigate whether the drug BMN 673 has therapeutic benefit in the treatment     of advanced endometrial cancer. Nearly 8,000 patients are diagnosed with endometrial cancer     in the UK every year. A significant proportion are either diagnosed with advanced disease     which may be inoperable and/or metastatic (i.e spread to other organs outside the     endometrium), or curable disease which relapses following first line treatment. There is no     established standard of care for these patients as both chemo and hormone therapy has limited     effectiveness and survival benefit. Survival rates have not improved in the past 20 years.     Furthermore there are no so called 'targeted' drugs licensed for its treatment i.e. drugs     that block the growth and spread of cancer by interfering with specific molecules involved in     tumor growth and progression. This leaves an unmet need for effective systemic treatments for     advanced, inoperable and metastatic endometrial cancer.      BMN 673 has been shown to be potentially effective in treating cancers known to behave     similarly to endometrial disease, both in the laboratory and in Phase I studies involving     patients with advanced cancers. Similarly the drug appears to be relatively tolerable. A     Phase II trial such as the one proposed by this application could demonstrate activity that     might lead to a new effective treatment for patients with inoperable, advanced, recurrent or     metastatic endometrial cancer, while the proposed substudy also presents the possibility of     discovering a subset of patients more likely to derive benefit from BMN 673.      This trial is for adult women (18 and above) with advanced, inoperable or metastatic     endometrial cancer. Patients will be recruited from approximately 15 National Health Service     (NHS) Trusts based in the United Kingdom (UK). The study is expected to last approximately     18-24 months in terms of recruitment time, and a maximum of 100 eligible women will be     registered. All patients will receive BMN 673 until their disease worsens or their doctor     decides they should stop treatment.   "
88541|NCT02127138|"     A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active     Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left     Main Bifurcation Lesions   "
88542|NCT02127125|"     The purpose of this study is to determine whether microbiome modulation and an experimental     reduction in plasma LPS concentration improve inflammation and insulin action in insulin     resistant (obese and T2DM) subjects.   "
88543|NCT02127112|"     This study with compare the ridge dimension changes for a block allograft vs. a demineralized     bone matrix moldable allograft.   "
88544|NCT02127099|"     Obstructive sleep apnoea (OSA) is a condition in which a person's sleep is disrupted with     momentary periods of apnoea and hypopnoea. This occurs when there is a blockage to airflow.     When this happens, the patient will snore, gasp or choke in the attempt to attain more     oxygen. This results in disrupted sleep and the patient may even awake from sleep.      It has been found that a great proportion of Malaysians have habitual snoring and with the     increase in obesity over the years, it is a concern that OSA may be prevalent in Malaysia.      However, it has been seen that OSA is commonly undiagnosed in patient. This poses a worry     because these people can come in for surgery. Diagnosis of OSA before surgery is important in     order to prepare for the complication related to OSA.   "
88545|NCT02127086|"     The purpose of this project is to test an innovative method for managing pain in acutely ill     hospitalized patients who are not able to report their pain verbally to health care     professionals. Nurses will use a Pain Assessment and Intervention for the Non-communicative     (PAIN) Algorithm to guide assessment of pain, selection of pain medications, and management     of medication side effects. The researchers will evaluate whether patients who are managed     with the PAIN Algorithm have less severe pain and increased use of pharmacologic pain     management strategies than those who are not managed with the PAIN Algorithm.      The study design is a non-randomized quasi-experimental cohort design with two cohorts who     will be sequentially studied. In phase 1, patients will comprise the usual care group (UCG),     or control cohort, defined as receiving pain assessment and management practices that nurses     are currently performing on the study units. In phase 2 the PAIN Algorithm coupled with     analgesic order sets will be introduced to nurses and physicians on all participating units     as the intervention. Patients enrolled in this phase will be considered the intervention     group (IG), also called the experimental cohort. Nurses will be enrolled from the     participating inpatient units to provide data on the clinical utility of the PAIN Algorithm   "
88546|NCT02127073|"     The purpose of this study is to examine the genetic material called microRNA of three types     of specimens from women with breast cancer. The study also seeks to examine the effectiveness     of using a new agent called oxytocin to increase the amount of nipple fluid that can be     collected during surgery.   "
88547|NCT02127060|"     Postoperative pain management remains a major challenge for surgeons. Despite huge     technological advances in pain management, many researchers have documented that unrelieved     pain remains common after surgeries, which is estimated that up to 75% of patients do not     achieve adequate pain relief postoperatively. The major goal in the management of     postoperative pain is to minimize the dose of medications to lessen the side effects while     still providing adequate analgesia, because side effects of commonly used pain medications     are known to be the reasons that could lead to inadequate postoperative pain treatment. This     goal is best accomplished with multimodal analgesia. One agent that can exert antinociceptive     and pain reducing effects is vitamin C.      Vitamin C (ascorbic acid) is water-soluble, found throughout the body and is especially     highly concentrated in the brain, which has antioxidant and neuroprotective properties.     Moreover, it has been proven that the plasma vitamin C concentration decreases after surgery     and the requirement for vitamin C increases in surgical patients, possibly due to greater     demand caused by increased oxidative stress. Regarding the effect of vitamin C on acute pain,     a result from a recent study with the aim to evaluate the potential role of vitamin C in     reducing acute pain after laparoscopic cholecystectomy showed that supplementation with oral     vitamin C significantly decreased morphine consumption after surgery.      Although vitamin C has potential for relieving postoperative pain, there has not been studied     regarding the effectiveness of vitamin C for spine surgery, to date. This trial aimed to     evaluate the effectiveness of vitamin C for surgery of lumbar spine.   "
88557|NCT02126930|"     The main objective of this study is to evaluate the impact of a pharmaceutical consultation     at the time of hospital discharge on the adherence of patients ; non-adherence is determined     by the following criteria:      As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria     is true:        1. . the patient did not go and get his/her treatment at the pharmacy;        2. . the number of treatment units dispensed by the pharmacy is < the number of treatment          units prescribed;        3. . the patient stopped taking a treatment before the recommended time, or continued          taking a treatment after the recommended time;        4. . the number of treatment units taken by the patient (self-declaration) is < or > to the          number of units prescribed.   "
88558|NCT02126917|"     To determine the influence of co-ingestion of alcohol on HC-ER.   "
88548|NCT02127047|"     Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the     course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass     in type 1 diabetes may be improved through inhibition of beta-cell destruction and     stimulation of proliferation, even after prolonged duration of disease.      Physical activity improves insulin secretion via unknown underlying mechanisms. We recently     observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release from     the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release of     Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6 levels.     Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like peptide-1     secretion from the islet α-cell and the intestinal L-cell, thereby providing a mechanism how     physical activity can help maintain and improve beta-cell function in patients with type 1     diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV inhibition.      Physical activity is also known to enhance insulin sensitivity and to attenuate the immune     system activity.      Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to     allow for beta-cell regeneration in a interventional randomized open-label study.   "
88549|NCT02127034|"     The purpose of this study is to evaluate the effect of steady state solifenacin and     mirabegron on the pharmacokinetics of co-administered steady state digoxin. This study will     also evaluate the safety and tolerability of the combined steady state administration of     solifenacin, mirabegron and digoxin.   "
88550|NCT02127021|"     Up to now, the studies concerning nutritional assessment after pancreatic resection were     rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant     benefit in terms of nutritional status. This study is a multicenter randomized phase IV study     by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status     after pancreaticoduodenectomy.   "
88551|NCT02127008|"     Posterior lumbar epidural fat commonly had been considered a simple space-filling tissue.     Anatomic studies on posterior epidural space and its contents are few, including semifluid     property. In other words, there has not been studied thoroughly regarding the significance     and role of posterior epidural fat in lumbar spine. In adults, epidural fat situated in the     posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface of     thecal sac. The fat tissue was covered by a thin membrane of connective tissue, which were     free under this layer. The anterior surface of this membrane lay close to the dura mater     without any attachment.      To date, the epidural fat has been resected routinely by pituitary forcep and suction     drainage during posterior lumbar surgery. However, the investigators focused on the role of     epidural fat, which might be associated with postoperative outcome. The investigators thought     that this peculiar character, epidural fat, should be caused by certain etiologies. In     general, each tissue, such as epidural fat, has its inherited features and significance,     thereby the epidural fat has also specific role. However, there has not been fully studies     regarding it. Thus, the investigators aimed to evaluate the impact of the posterior epidural     fat on the postoperative outcomes such as pain intensity and functional outcomes by whether     the epidural fat would be resected or not during posterior decompressive surgery. The     investigators hypothesized that the epidural fat would be associated with postoperative pain     intensitive, functional outcomes, and complications of the surgery such as failed back     surgery syndrome. In this study, new device for resection of epidural fat was not utilized,     but just resected with conventional devices such as pituitary forcep.   "
88552|NCT02126995|"     This study is a multisite, randomized, double-blind, placebo-controlled, phase 2 study of     MG01CI (low dose and high dose once daily) for 6 weeks compared with placebo in a 1:1 ratio     of 60 adolescent and adult subjects with Fragile X Syndrome (FXS). Following Screening,     subjects will be randomized to MG01CI or matching placebo at Baseline (Day 0) and the 6 week     Double-blind Treatment Period will begin on Day 1.      The first 4 weeks of the treatment period will be a dose-optimization period,      All subjects will start with two daily tablets: low dose metadoxine or matching blinded     placebo. At weekly visits/phone assessments, the investigator will evaluate the dose based     upon the investigator's assessment of safety and tolerability. If the subject demonstrates     safety or tolerability concerns with the low dose after 1 or 2 weeks of treatment, then the     subject will be discontinued. If there are no concerns about safety and tolerability after 2     weeks of treatment, then the dose will be increased to high dose or placebo. If at the high     dose there are concerns about safety and tolerability, then the dose will be either kept the     same or reduced to low dose for the remainder of the treatment period.      There will be a 2-week Follow-up Period after the last dose of study treatment or early     termination.   "
88553|NCT02126982|"     Clopidogrel besylate (CB) is not differentiated relative to the orignal clopidogrel hydrogen     sulfate (CHS) in the pharmacokinetics and in antiplatelet potency in healthy volunteers. In     addition,CB exhibits similar pharmacodynamic properties compared to CHS in patients with a     history of acute coronary syndrome (ACS) and in patients with ACS undergoing percutaneous     coronary intervention (PCI). However, there is a lack of data on the clinical efficacy and     safety of this salt to the original salt in patients with cardiovascular disease. The aim of     this study is to investigate the clinical efficacy and safety of CB in relation to that of     CHS in patients eligible to receive clopidogrel.   "
88554|NCT02126969|"     The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely     low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this     effect differs from the cellular effect of higher, standard fractions of radiation used in     traditional radiation treatment paradigms.   "
88555|NCT02126956|"     The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to     identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them     with the known metabolic profiles of ACT-128800 in animals.   "
88556|NCT02126943|"     Prospective observational drug registry developed to characterize the safety profile     (including primarily potential serious hepatic risks) and to describe clinical     characteristics and outcomes of patients newly treated with Opsumit in the post-marketing     setting.   "
89015|NCT02120924|"     The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic     Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of     moderate facial rosacea.   "
88559|NCT02126904|"     The investigators compared the time to recurrence after ranibizumab or aflibercept loading in     patients with AMD.   "
88561|NCT02126878|"     Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed     fluid filled sac or sac-like cavity found between tissues that function as a gliding surface     to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the     trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of     trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local     steroid injection. The injection consists of a mixture of local anesthetic and steroid     medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to     diluent the steroid as well as act as a pain reliever. Various steroid preparations have been     used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is     commonly used for various reasons. Besides the procedure associated and injection site risks,     risks associated with the use of steroids, though rare, exist. Short term, the steroid can     raise blood sugar levels and should be used with caution and be appropriately monitored in     diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are     related to the dose and frequency of use. These risks include thinning of the skin, easy     bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and     joints. Studies have shown the effectiveness of local steroid injections for trochanteric     bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation.     Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various     doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the     effectiveness of local steroid injections of various steroid dosages for the treatment of     trochanteric bursitis.   "
88562|NCT02126865|"     The primary objective of this trial is to investigate the safety and tolerability of BI     1060469 in healthy male and female subjects after oral administration of repeated rising     doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in     asthmatic male and female patients after oral administration of repeated rising doses of 25     mg and 150 mg qd of 1 day followed by 28 days.      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose     proportionality, dose linearity after single and multiple dose segments, pharmacodynamics     (PD) of BI 1060469 and to describe the PK/PD relationship.   "
88563|NCT02126852|"     This study evaluates three different neuromuscular monitoring devices (acceleromyography,     one- or three-dimensional, and electromyography) with regard to their precision to detect     residual paralysis after injection of neuromuscular blocking agents and recurrence of     paralysis after administration of reversal agents in a clinical setting.   "
88564|NCT02126839|"     The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared     to placebo in pediatric participants with asthma.   "
88565|NCT02126826|"     -  To investigate the safety and tolerability of BI 1026706 in male and female healthy          subjects and osteoarthritis (OA) patients following oral administration of repeated          rising doses        -  To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and          female healthy subjects and OA patients        -  The assessment of pharmacodynamics in OA patients   "
88566|NCT02126813|"     Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs     intermittent bladder catheterization after surgery, as they are transient incapable of     voluntary bladder emptying (postoperative urinary retention - POUR). The currently used     interventional threshold for urinary bladder catheterization are a bladder volume of     approximately 500 ml., but no evidence exists for this threshold. At the same time, the     current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in     humans, and as the use of urinary bladder catheterization are increasing the risk of     complications, the investigators are hypothesizing that increasing the interventional     threshold for urinary bladder catheterization after fast-track total hip or knee     arthroplasty, will reduce the number of patients needing urinary bladder catheterization,     without increasing the incidence of urological complications - including urinary tract     infections.   "
88567|NCT02126800|"     Treatment of breast cancer has traditionally been based on the primary tumour's features in     the breast. Only recently, when cancer returns at other sites, has there been an attempt to     biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be     technically difficult, painful and, when possible, only represents a small sample of one of     many metastases.      Even when one deposit responds to a new treatment, a neighbouring one may continue to grow.     There is an urgent need to characterise all deposits, particularly the lethal ones which     progress despite all treatments.      This study will enable the comprehensive analysis of the metastatic process and the evolution     of the breast cancer through the course of its treatment. Patients who have consented during     life to donate their tissues for molecular analysis will provide the means for such an     analysis.      Main aims:        -  To comprehensively and systematically examine metastatic breast cancer by its detailed          exploratory molecular characterization to elucidate the possible inter- and          intratumoural heterogeneity between the primary tumour and the majority of metastatic          sites.        -  To map the natural history of the metastatic breast cancer process   "
88568|NCT02126787|"     Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in     day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality     disorders in Poland. There is not enough evidence for its effectiveness in this environment.     This study addresses this gap. The aim is to determine the effectiveness of the two kinds of     day treatments consisting of intensive, short-term group therapy: psychodynamic and     cognitive-behavioral for patients with anxiety disorders and comorbid depressive or     personality disorders. Our objectives are: 1) Demonstrating effectiveness of each treatment     in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and     long-term effectiveness of the two active treatments; 3) Preliminary examination of     predictors and moderators of treatment response; and 4) Preliminary examination of mediators     of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the     outcome of used measures.      Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety     disorders and comorbid depressive or personality disorders will be assigned to one of three     conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) waiting     list (control group). Therapy will last 12 weeks. Both treatments will be manualized (manuals     will address comorbidity). Primary outcome measures are include self-report symptoms of     anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of     anxiety disorder. Secondary outcome measures include personality, depression, self-esteem,     defense mechanisms, beliefs about self and others, interpersonal problems, object relations,     parental bonding, meta-cognition, mindfulness and quality of life: symptoms of anxiety,     depression, personality, self-esteem and defense mechanisms. Measures are taken at baseline,     post-treatment and 3 months following the end of the therapy.      Discussion: The randomized controlled trial format is used to compare effectiveness of     intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for     anxiety disorders and comorbid depressive or personality disorders. The rationale is to     investigate how effectively anxiety disorders and comorbid personality disorders can be     treated in a day hospital typical for Polish healthcare system in 3 months treatment.   "
94639|NCT02047357|"     To test the efficacy of an innovative affordable intervention program that can be used by     non-specialists, including mothers and lady health workers with minimal training in low     resource countries such as Pakistan   "
88573|NCT02126722|"     H. pylori infection is the most important causative agent of gastritis, and subsequent     atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests     such as the Clo test. However, treatment with proton pump inhibitors (PPI) impairs the     diagnostic yeld of urease tests. The EndoFaster test (NISO BioMed, Turin, Italy) is a new     technology that has the advantage, over conventional urease tests, of a real-time analysis of     the gastric juice that can provide information regarding Helicobacter pylori infection and pH     value of the gastric contents. A well designed clinical study is therefore warranted to fully     assess the performance of the EndoFaster test in detecting H. pylori infection in patients     treated with PPI. We aim to perform a clinical study in an adult population in United Kingdom     in order to determine the diagnostic accuracy of the Endo Faster test compared to the Clo     test, histological diagnosis and the faecal antigen test in evaluating H.pylori infection.     Patients on PPI will undergo a gastroscopy with multiple biopsies and during the exam NISO     Biomed EndoFaster test, as well as the Clo test, will be carried out. H. pylori faecal     antigen test will also be performed and used as gold standard. Diagnostic accuracy of the     different methods will be determined.   "
88574|NCT02126709|"     Importance This will be a proof of concept study - whereby we hypothesize that Repigel may     represent a paradigm shift in global acne treatment.      Historically, there has been a dearth of clinical evidence in this use of povidone-iodine for     inflammatory acne. This is likely due to staining related to iodine use, which is not     acceptable to consumers.      The trial drug, Povidone Iodine, however, becomes colourless and odourless in a matter of     seconds after application on the skin.      This represents an ideal product for which we may perform testing to look at its efficacy in     the management of acne.      A mainstay in the pathogenesis of acne involves the overgrowth and proliferation of skin     micro-organisms, primarily proprionibacterium Acnes. Long term antibiotic therapy is usually     prescribed for a period of 3 to 6 months or more.      Previous studies have revealed this form of antibiotic therapy is ineffective, patients are     usually poorly compliant, and also results in the formation of antibiotic resistant     micro-organisms,which in turn reduces treatment efficacy.      Potential Benefits      As such, Povidone Iodine with its antiseptic property represents a promising avenue for the     elimination of Proprionibacterium Acnes without the associated problems of long term     antibiotic use, and the development of antibiotic-resistance. It is cosmetically acceptable,     affordable, and easy to use.   "
88575|NCT02126696|"     This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral     therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic     treatment failure as well as chronic communicable and non-communicable comorbidities among     patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to     determine prevalence of treatment failure as well as the prevalence of the following     comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol     use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with     treatment failure or a comorbidity or both are followed-up for 12 months.   "
88625|NCT02126046|"     Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia     major at present. To expand donor pool，we developed a haplo-identical HSCT (Hi-HSCT)     platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients     with leukemia, cytopenia post-transplant often developed, which was considered as a symptom     of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the     Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of this     study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of Hi-HSCT     in patients with β-thalassemia major.   "
89035|NCT02120664|"     This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission     Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.   "
88576|NCT02126683|"     Hashimoto's thyroiditis (HT) is a common form of autoimmune thyroid disease, which affects up     to 2% of general population. The annual incidence of HT worldwide is estimated to be 0.8 -     3.5 cases per 1000 persons. The thyroid gland attacked by a variety of cell- and     antibody-mediated immune processes. Various auto-antibodies may be present against TPO and     Tg, and ADCC is a substantial factor behind the apoptotic fall-out of HT. Activation of     cytotoxic T-lymphocytes in response to cell-mediated immune response affected by helper     T-cells is central to thyrocyte destruction. Recent studies showed higher pro-inflammatory     cytokines in serum of patients with HT, and suggested HT is associated with regulatory     T-cells dysfunction, imbalance of ratio of Th1 cell and Th2 cell, overexpression of Th17     cells.      Several studies suggested that pregnant women with HT, even at euthyroid state had higher     risk of spontaneous miscarriage, more frequent post-partum depression and higher depressive,     anger, and total mood disturbance risk compared to those without HT. Presence of thyroid     auto-antibodies is also associated with negative pregnant outcomes including gestational     hypertension, late abortion, fetal death, premature delivery and neonatal respiratory     distress. Neonates from mothers with ATD have higher rate of transient hypothyroidism.     Children of mothers with ATD had higher risk of positive serum thyroid auto-antibodies and     development of goiter and thyroid dysfunction. However, there is no suggested treatment for     subjects with HT who have normal thyroid function. Low-iodine diet and regularly follow-up     were suggested.      Plaquenil (hydroxychloroquine) is an anti-malarial agent, and has been used to treat several     autoimmune diseases, including lupus erythematosus and rheumatoid arthritis for more than a     century. It reduced lymphocytes, production of auto-antibodies, cytokines, and immune     mediators, NK cell activity, and inhibits antigens presenting to CD4 T-cells of B cells,     dendritic cells and monocytes.      This study focuses on the effect of Plaquenil on thyroid auto-antibodies, inflammatory     markers, cytokines, and goiter size in euthyroid women with HT.   "
88577|NCT02126670|"     The purpose of this study is to determine whether or not ACT01 is effective and tolerable     alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with     facial and/or scalp keratosis.   "
88578|NCT02126657|"     Our study involves the evaluation of a high potency chemical peel in its efficacy and safety     profile for the treatment of acne scars. This chemical peel regime is a high potency peel of     70% glycolic acid combined with vitamin C that is purported to provide a good balance between     yielding results and patient safety. We aim to evaluate its efficacy and safety profile of a     single application. The study design is based on a single group that compares pre- vs     post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be recruited.     Potential benefits include improvement of post acne scars with a short downtime and risks     include post peel hyper pigmentation and scarring. We believe that this treatment will be     highly beneficial to patients with post acne scarring.      This chemical peel regime has good efficacy and safety profile for the treatment of acne     scars.   "
90391|NCT02102919|"     The goal of this randomized controlled study was to examine the effects of a 8 weeks     innovative training regime (stochastic resonance whole-body vibration [SR-WBV] and virtual     virtual games [VG]) in the skilling up phase on physical performance and strength in elderly     in need of care population.   "
88579|NCT02126644|"     Our study involves the evaluation of a high potency peel in its efficacy for skin     rejuvenation in the treatment of photoaging. This chemical peel regime is a high potency peel     70% glycolic acid combined with vitamin C that is purported to provide a good balance between     yielding results and patient safety.      AIM We aim to qualitatively evaluate its efficacy and safety profile.      Our hypothesis is that a single peel of 70% glycolic acid combined with vitamin C will result     in improvement of the features of photoaging with few side effects.   "
88580|NCT02126631|"     This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a     patch monitoring system, with the Holter monitoring system. Holters represent the current     standard for continuous recording of the ECG over extended periods.   "
88581|NCT02126618|"     The aim of this study is to estimate the amount of extra urine produced by natural diuresis     during 20-minute pad test, and assess the effect of diuresis on the accuracy of using     20-minute pad test to estimate the severity of SUI. Besides, the above results may be used     for further refinement of the amount of water infusion used for the 20-minute pad test.   "
88582|NCT02126605|"     Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a     way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed     the ability of DADs to accurately detect extreme high and low blood sugar. The current     project is the first preliminary investigation into the accuracy of DADs, using     scientifically rigorous research methods similar to those required to demonstrate accuracy in     blood glucose meters. The primary aim of the project is to test the hypotheses that DADs are     accurate at detecting extreme blood sugar levels in adults and children with T1D. The     proposed project has several other secondary aims, which include determining: 1) the glycemic     thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which     alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear     to experience better psychosocial status and quality of life compared to other individuals     with T1D.   "
88583|NCT02126592|"     Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is     characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic     abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost     60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS     patients tend to be overeating suggests that impaired appetite regulation might be contribute     to the pathophysiology of PCOS. Our study is trying to observe difference of incretin between     PCOS and normal control to figure out whether change of incretin is involved in the     pathophysiology of PCOS.   "
88585|NCT02126566|"     Striae distensae is a common skin condition that rarely causes significant medical problems.     However, it often results in a considerable amount of distress to those with the condition.     Various modalities of treatments have been used for striae distensae but few have led to     satisfactory results.      More recently, newer techniques such as pulsed dye laser and radiofrequency devices have been     used with modest results. There is still, however, paucity of data using light therapy for     the treatment of this condition. Blue light therapy using the Multiclear device has been used     successfully in the treatment of acne. In contrast, there is little data to suggest its use     in the management of striae distensae.      We aim to study the effects of blue light on the treatment of striae distensae and whether     this can be used safely to manage this condition.   "
88586|NCT02126553|"     The goal of this clinical research study is learn if Revlimid® (lenalidomide) can help to     keep AML patients in remission. The safety of this drug will also be studied.   "
88587|NCT02126540|"     To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while     using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of     plaque from diseased lower extremity arteries.   "
88591|NCT02126488|"     The long-term objective of this research is a prophylactic approach that can reduce the     incidence of falls and the resulting injuries among older adults at risk and thus reduce its     escalating medical cost. This project explores perturbation training through the use of     treadmill device and a motor learning approach, in which experience with slip-like     perturbation generated by that treadmill is used to prepare the motor system to develop and     then put to use fall-resisting skills outside of training environment (cross-environment     transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus     conducive for use in clinics or community centers. The study logically builds on and     complements the team's previous and current research programs, and will further test that     after such a single session, older adults at risk can retain such cross-environment transfer     and reduce their likelihood of falls in everyday living for the next 6 to 12 months. Finally,     the study will explore that such reduction of falls does not come merely from these persons'     familiarity with the training or testing setup, protocol and environments.   "
88592|NCT02126475|"     Although major progresses were realized during recent years, temporal cognition is still     poorly understood. However, abnormal temporal cognition is an underestimated aspect of     several neurological disorders, particularly if basal ganglia (BG) are affected. Therefore,     the interest of studying temporal cognition is double: firstly, it is an essential function     necessary to guide all behavior; secondly, it seems to be very sensitive to the integrity of     dopaminergic pathways. It is well known that Parkinson's disease (PD) is partly due to a     degeneration of neurons producing dopamine in the Substantia Nigra pars compacta (SNc).     Therefore, in this project, PD patients and healthy volunteers will be used as a model to     study the role of dopamine in temporal expectation.      An expectation is an internal representation of an event that is likely to occur in the     future. Temporal expectation builds-up as time elapses before the upcoming event. The role of     temporal expectation in the oculomotor domain has often been studied using anticipatory eye     movements as a tool. Indeed, expectation evokes anticipatory eye movements. However, to the     knowledge of the investigators, expectation and anticipation have so far been studied in     experimental tasks where temporal information is essential but not voluntarily controlled.     This is usually referred to as 'automatic' or 'emergent' timing: the timing of the eye     movement adapts to the timing of the target, implicitly and without voluntary control of the     subject. However, anticipatory movements can also be based on an explicit estimation of time,     e.g. during music playing. In summary, timing can be based on cognitive (explicit) or     automatic (implicit) processing. The originality of the behavioral task the investigators     will use in this study is that it will require an explicit comparison of a memorized duration     with elapsing time in order to anticipate target appearance. In this task, expectation of the     upcoming event will build up on explicit temporal information.      Same PD patients will be tested under treatment (ON) and without treatment (OFF) to     determine the effect of dopamine in time expectation . Only levodopa responsive Parkinson     patients will be included and among them only those receiving levodopa and/or dopa agonists     three times daily at a stable dosis since 30 days.      the investigators hypothesize that eye movements latency will not linearly covary with     objective time in OFF PD patients. In treated PD patients, a recovery of the linear     relationship between subjective and objective time is expected. This would clearly     demonstrate the role of dopamine in temporal expectation in humans.   "
96878|NCT02018120|"     The aim of this randomized controlled clinical study is to evaluate and compare the     effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of     multiple gingival recessions.   "
88593|NCT02126462|"     Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus     hookworm life cycle that are thought to play a role in the parasite's degradation of host     hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1 has     protected dogs and hamsters from infection in challenge studies. This study will evaluate the     safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese     adults living in an area of endemic hookworm infection.   "
88594|NCT02126449|"     Preclinical studies provide strong support for the concept that fasting evokes resistance to     multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates     intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance.     Accordingly, the currently available preclinical evidence suggests that short-term fasting     protects normal cells against the perils of chemotherapy. In contrast, cancer cells are not     protected, as a result of their self-sufficiency in growth signals. This phenomenon is termed     Differential Stress Resistance (DSR). DSR reduces the severity of toxic side-effects of     chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to     chemotherapeutics. Importantly, extensive preclinical evidence and preliminary clinical data     indicate that a specifically designed very low calorie, low amino acid substitution diet     (Fasting Mimicking Diet, FMD) has effects on cancer therapy that are very similar to those     of fasting. This study aims to evaluate the impact of the FMD on tolerance to and efficacy of     neoadjuvant chemotherapy in women with stage II or III breast cancer.   "
88595|NCT02126436|"     The purpose of this study is to evaluate the feasibility and effectiveness of acupuncture for     the treatment of phantom limb syndrome in lower limb amputees and pilot an acupuncture     protocol. The study will be a comparative effectiveness study comparing acupuncture and     standard care versus standard care alone and will be a randomised controlled trial using a     mixed methods approach. The study hypothesis is a course of acupuncture will reduce the     symptoms of phantom limb syndrome in lower limb amputees.      The study will be based the Amputee Rehabilitation Unit, London. Twenty lower limb amputees     with phantom limb syndrome will be randomly assigned to either receive usual care or usual     care plus acupuncture. Acupuncture intervention will include 8 treatments over 4 weeks and     treatment will involve using both body and auricular acupuncture points. Usual care will     include physiotherapy, occupational therapy, pharmacological intervention and other     interventions as deemed appropriate by clinical staff.      An eleven point numerical rating scale will be the primary outcome measure in this study.     Secondary outcome measures will include the Short Form McGill Pain Questionnaire 2, EQ-5D-5L,     Hospital Anxiety and Depression Scale, Perceived Stress Scale, Insomnia Severity Index,     Participant Global Impression of Change and information will also be obtained on rescue     medication. A cheek swab will also be taken to explore potential subgroups of responders in     relation to the genetic polymorphism of the glucocorticoid receptor. Outcomes will be     recorded weekly for the duration of the study and one and three months post completion of the     study. In order to identify protocol acceptability and acceptability of outcome measures five     participants will be interviewed post completion of the study. Data will also inform     feasibility such as recruitment rate, completion rate and reasons for dropout.      Data from this study will guide the development of a full randomised controlled trial.   "
88596|NCT02126423|"     The administration of short courses of topical antibiotic drops before and/or after     intravitreal injections is a common practice, but increasing evidence suggests this may not     lower the risk of infectious endophthalmitis and could increase rates of antimicrobial     resistance. The purpose of the present study is to determine the antimicrobial resistance     profiles in patients who have received numerous (≥ 20) courses of antibiotics for     intravitreal injection compared with untreated controls.      This study compares 20 control patients without prior intravitreal injection to 20 patients     who have undergone ≥ 20 prior intravitreal injections accompanied by a course of topical     antibiotics for two days before and/or after the injection procedure. The lower, inner eyelid     and nasal cavity were cultured and evaluated via disk diffusion method for antimicrobial     sensitivity.   "
88626|NCT02126033|"     Celiac disease is an autoimmune process that causes destructive changes in the epithel of the     small bowel and it is also a pre-malignant state (e.g lymphoma). The aim of the study is to     examine telomere length and other parameters of genetic instability from peripheral blood     lymphocytes of patients with celiac disease compared with healthy controls.   "
91373|NCT02090088|"     US study to estimate the prevalence at birth of major birth defects (ie, those that cause     significant functional or cosmetic impairment, require surgery, or are life-limiting) in     children born to mothers who have received Nplate® therapy at any time during the pregnancy.   "
88597|NCT02126410|"     1. BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese          population. However, within the context of self-reported sleep duration and health          risks, research into the association between sleep duration and body composition changes          in older people is limited. It is important to gain an understanding of such an          association of older people to estimate the public health burden.        2. OBJECTIVES: To assess the association between self-reported sleep duration and          sarcopenia as well as obesity in community-dwelling older adults.        3. HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and          obesity in community-dwelling older adults.        4. DESIGN: A cross-sectional investigation.        5. SETTING: Communities in Zhongzheng district, Taipei.        6. PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264          women) aged 65 years and older.        7. MEASUREMENTS: The investigators evaluated self-reported sleep duration by deriving from          the Pittsburgh Sleep Quality Index and 7-d recall physical activity diary. Skeletal          muscle mass was estimated by the predicted equation from a bioelectrical impedance          analysis measurement. The Groningen Activity Restriction Scale and the Chinese Geriatric          Depression Screening Scale were used to evaluate physical disability and depression,          respectively.   "
88598|NCT02126397|"     Hysteroscopy today is considered the gold standard for the diagnosis and treatment of     endometrial polyps. In recent years we have used the bipolar energy for resection of polyps     by hysteroscopy, becoming a routine clinical practice and universally accepted.      Resection of endometrial polyps laser energy has recently begun to be used with satisfactory     results, so studies are needed to analyze these results and compare it with the usual     techniques .      This time in advance of medicine, it is appropriate to introduce minimally invasive     procedures , allowing resection of endometrial polyps on an outpatient basis without     anesthesia and acceptable to most patients.      These procedures assume a lower cost and are associated with a lower surgical risk due to     their realization without anesthesia .      Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of     the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique     with a high percentage of resection and high degree of satisfaction of patients   "
88600|NCT02126371|"     LEO 32731 (Study Drug) is an investigational drug which is being developed by LEO Pharma     A/S (the Sponsor), with an aim to help people with skin conditions called psoriasis. The     aim (s) of this Study are to determine:        -  The effects of the Study Drug when given as different formulations intended for oral          administration (tablets and capsules)        -  The safety of the Study Drug and any side effects that might be associated with it        -  The effect of food on the Study Drug        -  The Study will also measure how much of the Study Drug gets into the blood stream and          how long it takes the body to remove it and what affect the Study Drug has on the body.   "
88601|NCT02126358|"     To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg     and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia   "
88602|NCT02126345|"     The purpose of this study is:        -  to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support          existing short-term clinical results and CE documentation;        -  to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT          acetabular cup under standard conditions of use;        -  to determine any adverse events and assess whether they constitute risks when weighed          against the intended performance of the device.   "
88603|NCT02126332|"     Acute pancreatitis (AP) is a common disease whose incidence in the US reaches 35 per 100,000     population annually. Its main causes in adults are gallstone migration into the common bile     duct and alcohol abuse. Approximately 80% of patients with AP will develop a mild disease for     which the management is mainly conservative. However 20% will develop a severe form, which is     known to be associated with the development of local complications, such as pancreatic and     peripancreatic necrosis, pseudocysts, and systemic complications, such as adult respiratory     distress syndrome or renal failure. In the severe form of AP the mortality rate can reach 17%     mainly due to multiple organ failure and pancreatic necrosis. In particular, pancreatic     necrosis is associated with a death rate of up to 40%.      Epidural anesthesia (EA) is widely used to induce analgesia in the perioperative period and     has also been used to decrease pain in patients with AP. In addition, experimental studies     have shown a specific beneficial effect of EA in AP, attributed to an anti-inflammatory     effect of local anesthetics administered in the epidural space combined with a sympathetic     nerve blockade, which redistributes splanchnic blood flow to non-perfused pancreatic regions.      To date, EA has not been adequately tested in intensive care unit (ICU) patients with severe     AP, with regards to clinical outcome. The objective of our study is therefore to test the     effect of EA on lung dysfunction during severe AP, as we hypothesize that EA could limit lung     failure requiring invasive mechanical ventilation (MV) or the duration of invasive MV   "
88604|NCT02126319|"     The purpose of this study was to examine whether a cognitive-affective preparation was more     beneficial, in general, and more specifically for certain subgroups, such as African-American     men and individuals with high monitoring style.   "
88605|NCT02126306|"     Oral administration of betaglucosylceramide was shown effective in reducing inflammation in     animal models and was found safe in humans.   "
88627|NCT02126020|"     The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several causes     of corneal blindness. Some categories of patients, including those with auto-immune diseases     such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous membrane     pemphigoid, have a higher risk of failure for the KPro. Because of chronic inflammation, the     cornea supporting the KPro may melt, leading to a higher risk of infection, loss of the KPro     and loss of the eye.      Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to     control inflammation in several diseases. It has been used in some cases of corneal melting     with significant success.      This study's hypothesis is that infliximab can be successfully used as an eye drop (instead     of the usual administration through veins) and that its regular use may prevent melt in eyes     with a Boston Keratoprosthesis type I and underlying auto-immune disease.   "
88606|NCT02126293|"     Children with chronic kidney disease, even after transplantation, may be at risk for bone     problems due to an imbalance of calcium and phosphorus in the blood, especially as their     kidneys progressively fail to function. While some drug and diet treatments are available to     prevent such bone disease, many children refuse to take them due to bad taste and tummy     cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can     form in the blood vessels, eventually clogging them and resulting in heart problems.     Investigators are studying possible new methods to help the kidneys maintain a normal balance     of nutrients in the blood which is important for growing healthy bones and the prevention of     side effects in blood vessels that can lead to heart disease. One method is to improve the     team work of a hormone FGF-23 and a protein called Klotho that together stimulate the kidneys     to increase phosphate removal. Investigators propose that this problem may be due to low     blood zinc levels which often occur in children with kidney disease. Thus, in this study,     investigators propose to first measure zinc in blood from children with chronic kidney     disease (CKD) or who have had kidney transplants to assess zinc and phosphate status, the     hormone FGF-23 and its assistant Klotho. If zinc status is low, the children will receive     zinc supplementation for 3 months. After treatment with zinc, the same blood measurements     will be repeated to determine if the zinc supplements have helped the hormones to remove     phosphate from the body. If this pilot project is successful, investigators will then     consider a larger scale project involving adult patients as well as pediatric patients from     other pediatric centers. This project will also guide investigators as to whether they need     to introduce zinc measurements as part of routine testing of CKD and transplant patients. In     addition to measuring zinc levels in study participants, trace elements (TE) will also be     measured. These include heavy metals such as cadmium, chromium, nickel, vanadium, copper,     lead, manganese and selenium. Very little is known about levels and metabolism of TE in CKD     especially before dialysis. In adults, cadmium, chromium, nickel, and vanadium probably     accumulate in hemodialysis patients, while copper and lead may accumulate. Manganese,     selenium are probably deficient. The study will allow investigators to obtain the information     about TE in this group of pediatric patients.   "
88607|NCT02126280|"     The study of proinflammatory and anti-inflammatory cytokines and chemokines expression     profiles in human monocytes to identify new effective biomarkers that have the best     diagnostic potential in asymptomatic atherosclerosis.   "
88608|NCT02126267|"     Evaluate and compare the effectiveness in a clinical and microbial perspective one stage     full-mouth disinfection technique in relation to scaling and root planing per quadrant     associated with chlorhexidine or azithromycin.   "
88632|NCT02125955|"     Currently, over one third of Canadian children and youth aged five to seventeen are     overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as     type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers.     Changes in the food supply have been linked to obesity and include a decrease in the intake     of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate     the composition and actions of the gut microbiota and have been shown to reduce body fat and     energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic     fiber intake in overweight and obese children will similarly result in improvements in body     composition and reduced energy intake.   "
88609|NCT02126254|"     The aim of this trial is to compare the efficacy of NICaS-directed treatment strategy to the     common treatment strategy (based on clinical judgment) on morbidity and mortality in patients     with decompensated congestive heart failure, and accordingly to assess whether the NICaS     system can optimize and individualize the treatment of decompensated heart failure patients.     A prospective randomized controlled trial in which Known HF patients, with reduced EF <40%,     admitted due to decompensated HF, will be randomly assigned, in a 1:1: ratio, to either: 1)     Control group that will be treated in the cardiology and internal medicine departments     according to the guidelines for the management of Heart Failure. 2) Hemodynamic group     patients will be examined in the cardiology and internal medicine departments and treated     according to the NICaS system in addition to current guidelines. Patients in this group will     be tested within 12 hours from hospitalization and thereafter on an everyday basis until     discharge. For all patients randomized, therapy will be tailored to the ultimate goal of     discharge on an oral medical regimen to provide better relief of CHF symptoms, to reduce     filling pressures and to maintain adequate perfusion. These goals are the same for both     groups, but in the control group therapy will be adjusted according to clinical assessment     alone, while in the NICaS-directed group, actual measurement of hemodynamics will be used to     supplement clinical assessment.   "
88610|NCT02126241|"     This proposal aims to evaluate the added clinical and echocardiographic benefit of using the     non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing     atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT     recipients.   "
88611|NCT02126228|"     The purpose of this study is to discuss whether the parturients who underwent elective     cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and     economic benefits involved.   "
88612|NCT02126215|"     Hypothesis: Patients with blue cerebrovascular reactivity (CVR) regional maps during a     hypercapnic CO2 challenge will be at greater risk of developing post-operative delirium (POD)     and stroke following major surgery. The blue CVR map will be shown to be predictive of POD     and stroke and ultimately represent a diagnostic test for patients at risk. These blue CVR     maps will enable neurologic risk stratification for patients undergoing major surgery. A     secondary hypothesis is that location and extent of the blue CVR maps will strongly indicate     risk of neurologic sequelae after operative procedures. Background: Major surgery is     associated with a significant risk of postoperative morbidity and mortality. POD is a dreaded     complication with such anesthesia and surgery. The prevalence of delirium after cardiac     surgery has been reported to occur in up to 50% of patients. Using a definitive diagnostic     tool such as the Confusion Assessment Method - Intensive Care Unit (CAM-ICU) results in the     higher proportion reported. Delirium is a serious complication that results in prolonged     length of stay, increased health care costs, and higher mortality. As much as $6.9 billion of     Medicare hospital expenditures can be attributed to delirium. At such a cost, better     diagnosis and treatment is urgently needed. Pre-emptive diagnosis leading to better     management of delirium post-operatively is clearly one of the fundamental problems     confronting modern anesthesia and peri-operative medicine.      Specific Objectives: The investigators seek to address (a) the identity of patients who have     the greatest vulnerability to the surgery and (b) investigate the risks and test appropriate     risk mitigations. Understanding POD is of immense import to help control a hospital's     surgical and critical care costs. Patients with neurological consequences including POD often     represent a choke point for optimized critical care utilization. At the very least, improved     understanding and a diagnostic test to highlight patients at risk of POD would be most     welcome. Such an advance would permit rational strategies to limit the problem and allow     better designed therapeutic arcs for patients now known to be at risk. This is especially     important for patients undergoing complicated major surgery and is the focus of this pilot     project.   "
88613|NCT02126202|"     A multicenter, randomized clinical trial in elderly patients (over 80 years old) with     unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).      A total of 200 patients will be randomized to medical treatment (100 patients) or coronary     angiography with revascularization if feasible (100 patients). Information regarding prior     history, frailty, clinical presentation, in-hospital events, complications, angina, quality     of life and mortality will be collected. Follow up time is 1 year.   "
88614|NCT02126189|"     This study is designed to refine the aetiological causes of cancers of the head and neck and     investigate the ways in which human papillomavirus and life-style factors cause head and neck     cancers. This study will determine if these factors affect the treatment of cancer.      All patients attending the Head and Neck Clinic at the Princess Alexandra Hospital is invited     to complete a risk factor questionnaire and give consent for their clinical data and tissue     samples to be available for future research activities. The risk factor questionnaire is     based on existing validated instruments developed by the QIMR Berghofer Medical Research     Institute Cancer Control Group, and will collect standardised information relating to     demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition,     asprin and non-steroidal anti-inflammatory drugs (NSAIDS), height, weight, physical activity,     diet quality etc) and behaviours (oral sex etc)   "
88615|NCT02126176|"     The purpose of this study is to determine whether the dosage of 0.1% tacrolimus ointment     applied on unit area of eczema influence the efficacy of treatment.   "
88616|NCT02126163|"     Excessive alcohol use is associated with a range of serious and costly health, social, and     economic consequences at the individual and societal level. This program of research serves     as a venue by which to produce and test an innovative, science-based, and cost-effective     means to intervene in a private, convenient, and individualized way with employed adults who     report non-dependent levels of risky drinking. Responsible Drinking offers computer-tailored     intervention sessions directed at increasing readiness to limit drinking to national     guidelines for low-risk drinking and a complementary dynamic web portal providing additional     information, activities, and strategies designed to activate and reinforce the change     process. The primary objective is to complete and enhance the development of Responsible     Drinking and test it in an effectiveness trial. In Phase II the program capabilities and     innovation will expand to integrate the e-Health components (CTI and e-Workbook) with     m-Health (mobile health) technologies. The e-Health components will be enhanced to offer a     more interactive and engaging user experience. In addition, m-Health technologies (text     messaging and mobile device browsing optimization) will be integrated to support engagement     in the program and flexible delivery options. 996 employed adults will be recruited to     participate in the randomized trial. The treatment group will receive three intervention     sessions during the course of six months and group differences on a number of outcomes will     be evaluated at 12 and 18 month follow-up assessments.   "
88919|NCT02122172|"     This phase II trial studies how well afatinib dimaleate works in treating patients with     urothelial cancer that cannot be removed surgically and has grown after treatment with     standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the     epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors,     which may slow the growth of cancer cells or cause some of the cells to die.   "
88617|NCT02126150|"     The UNICORN consists of two collaborating biobanks, one in Utrecht and one in Singapore. From     these two sites we include all patients who undergo a coronary catheterization for any     reason.      At the moment of catheterization we draw blood, which will be stored in a biobank and we     collect clinical characteristics. Patients are followed-up for 5 years for the occurrence of     major cardiovascular events.      By including from two sites in the world we include 4 major ethnic groups: Caucasians,     Chinese, Indians and Malays. We aim at including at least 2000 patients per ethnic group.      Our hypothesis is that there are differences in the risk factor burden, clinical presentation     of CAD, and biochemical patterns in the blood among the ethnic groups.      Furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.   "
88618|NCT02126137|"     Infection by hepatitis C virus (HCV) affects more than 170 million people in the World and     80.000 in Chile. It causes more deaths than HIV infection in the US and is a leading cause     for liver transplantation in Chile. Even though treatments are evolving with new direct     antiviral agents (DAAs) that are increasing response rates, there are several issues with     these new approaches, including increased toxicity, need for using interferon and ribavirin,     complex algorithms of treatment, high cost, limited effectivity in certain groups (liver     transplant patients) and drug interactions. Treatments targeted at host factors required for     the viral cycle are becoming increasingly explored as an alternative or complement to DAAs.     It has been recently described that Niemann-Pick C1-like 1 (NPC1L1), the intestinal receptor     of cholesterol, serves as an entry factor for HCV. NPC1L1 is, therefore, a key transporter in     the enterohepatic cycle of cholesterol. NPC1L1 can be blocked with ezetimibe, which is an     approved and generally safe drug used for the management of hypercholesterolemia. Our     hypothesis posits that blocking HCV entry to the hepatocyte or intestinal HCV reabsorption     with ezetimibe may have an antiviral effect. In the study, we will administer ezetimibe 20     mg/d to 20 patients with stable chronic hepatitis C for 12 weeks and assess changes in HCV     RNA and core antigen in plasma, bile and feces.   "
88619|NCT02126124|"     The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham     treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette     smokers.   "
88620|NCT02126111|"     The purpose of this study is evaluate the efficacy of a depigmented grass extract in the     treatment of local allergic rhinitis.   "
88621|NCT02126098|"     The purpose of this study is to observe the clinical manifestation, Lab findings including     chest CT scans, pathological findings and outcomes in chinese patients with pulminary     vasculitis.   "
88622|NCT02126085|"     Sedation vs Intubation for Endovascular Stroke TreAtment Trial (SIESTA) is a prospective,     randomised controlled, monocentric, two-armed, comparative trial. Patients are randomized 1 :     1 to either non-intubated state or to intubated state for endovascular stroke treatment.     Otherwise, no principal differences in intensive care treatment are intended, and standard     operating procedures are applied to ensure uniform management decisions in fields such as     ventilation, sedation, cardio-vascular and cerebral monitoring and management.   "
88623|NCT02126072|"     Objective: To determine the immediate effects of oral alcohol consumption in healthy     volunteers on gut wall integrity as measured by I-FABP and LBP.      Study design: Randomized, single blinded cross over study.      Study population: 15 healthy adult male human volunteers will be included in this study.      Intervention: the consumption of alcoholic beverages (1 g/kg ethanol) of wine (12%) compared     to the consumption of water.      Main study parameters/endpoints: The aim of this study is to determine the immediate effects     of oral alcohol consumption in healthy volunteers on gut wall integrity as measured by I-FABP     and LBP.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Subjects consume 1g of alcohol per kg bodyweight. One blood sample of 14 ml     followed by 6 samples of 8 ml will be drawn between 16.45 hours and 19:00 hours the day     after. The first 6 observations take place in a single visit followed by one observation in     short visit the next day. It is unlikely that subjects will experience any physical or     psychological discomfort from the withdrawal of a total of 62 ml of blood in 24 hours or the     consumption of the amounts alcohol or water mentioned above. The same protocol will be     repeated one week after the first visit in which the alcohol group and water group are     crossed over.   "
88624|NCT02126059|"     Cognitive function, behavioral and psychological symptoms, and quality of life will improve     after administration of cognitive stimulation therapy, reminiscence therapy, and     aroma-massage therapy in patients with dementia.   "
88650|NCT02125721|"     The purpose of this study is to evaluate the effect of escalating doses of cystine biding     thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which     is a measure of the amount of cystine in the urine, in patients with cystinuria. The overall     goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by     larger doses.   "
91387|NCT02089906|"     This study is aiming to understand the prevalence and risk factors related to malnutrition     and sarcopenia in Chinese elderly.   "
88628|NCT02126007|"     This randomized clinical trial (RCT) pilot study as two main objectives:        -  determine the overall feasibility of a behavioral intervention for managing fatigue          among older adults with HIV infection.        -  to estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions          of fatigue.      The investigators hypothesize that adherence, satisfaction, and attrition will be similar for     the active intervention group and the attention control group. The investigators also     hypothesize that all five dimensions will improve in the intervention group compared to     controls over time, and that Cohen's d (Standard Deviation units) will be greater than 0.5 SD     units for all five fatigue dimensions at all three post-intervention time points.   "
88629|NCT02125994|"     It is established that the local anesthetic that is administered during an interscalene block     affects the autonomic outflow to the heart. This is very well seen during shoulder surgery     when the patient is positioned in beach chair pasition.      The investigators want to study the different effect of the two concentrations (0.5% and     0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate     measurements.   "
88630|NCT02125981|"     The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.   "
88631|NCT02125968|"     The purpose of this study is to investigate the video game play therapy in patients with     chronic low back pain.   "
88633|NCT02125942|"     Borderline personality disorder is a severe psychiatric disorder marked by emotional     instability, difficulty with interpersonal relationships, and self-harming behaviors. Despite     receiving psychotherapy for borderline personality disorder, studies show that patient     recovery is slow, and there is a high rate of self injury and suicide attempts early in     treatment. There is thus a clear need to provide therapies to augment psychotherapy. We will     conduct a pilot trial to determine whether a 6-week Central Meditation and Imagery Therapy     (CMIT) is feasible for subjects with borderline personality disorder to undergo when added on     to psychotherapy treatment. CMIT is a non-validated therapy that combines principles of     mindfulness with meditation techniques and guided imagery. Sessions led by a trained     clinician in a group setting once a week, and participants are asked to complete daily home     practice.      The trial will involve 16 participants, all currently undergoing psychotherapy for borderline     personality disorder. Participants will be randomly assigned to either a CMIT group that     lasts 6 weeks, or a wait list group. Those in the wait list group will be able to receive     CMIT after 6 weeks. All participants will continue to receive psychotherapy throughout the     trial.      During the trial, we will also obtain preliminary data to help understand whether CMIT may     result in psychological benefits for participants. This will include measuring the pulse in     order to determine variation in beat to beat intervals of the heart during psychological     tests, and filling out questionnaires before and after participation in CMIT.   "
88634|NCT02125929|"     To determine the efficacy and safety of robotic, laparoscopic and open surgery for     enucleation of benign pancreatic neuroendocrine tumors   "
88635|NCT02125916|"     The objective is to study the cognitive functions in patients with chronic obstructive lung     disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy     controls. The cognitive functions are tested with and without oxygen therapy to clarify the     effect of oxygen therapy. Driving simulations is used to test the cognitive functions.      The hypothesis is that patients with chronic lung disease have decreased cognitive functions     and that oxygen therapy will increase their cognitive functions.   "
88636|NCT02125903|"     The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after     total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by     femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital     stays are extended.      An alternative method could be an adductor canal block (ACB). Anatomical studies of the     adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure     sensory nerve for medial and anterior aspects of the knee and the tibia without any motor     function.      This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on     quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).      We expect the ACB to be superior in muscle strength but equal in pain score. Both groups     receive an additional anterior sciatic nerve block for complete sensory block of the operated     knee   "
88637|NCT02125890|"     An abdominal aortic aneurysm occurs when the part of the aorta travelling down into the     abdomen balloons out more than 50%. If caught early, treatments can be used to prevent     rupture of the aneurysm. However, many of these aneurysms are asymptomatic and go undetected     until they rupture, causing large amounts of blood to spill into the abdominal cavity and     typically leads to death, if left untreated. The current mortality rate is between 50 and     90%. The resources required to treat patients with ruptured aortic aneurysms is quite     substantial given that they need blood transfusions and can have prolonged hospital stays.     Patients either undergo a more invasive operative repair, associated with greater blood     products transfusions and complications, or if relatively stable, undergo a less invasive     repair with tubes called stents. There is less morbidity associated with the latter,     endovascular repair. To prevent blood loss in elective surgeries, drugs that promote blood     clotting are often used. One drug, tranexamic acid , has been shown to reduce blood loss,     reduce the number of blood transfusions required and improve patient outcomes in elective     cardiac and orthopaedic surgeries, and more recently, in patients with traumatic hemorrhage.     However, this drug has not been tested in this particular population. The purpose of this     pilot project is to evaluate the effectiveness of tranexamic acid in reducing clinically     significant bleeding in patients with ruptured aortic aneurysms in hospital sites across     Saskatchewan using a single-group intervention design. The investigators will compare the     data from patients treated with tranexamic acid to retrospective data from a control group     that is matched on key variables. The investigators predict that tranexamic acid will result     in reduced bleeding, reduced need for blood transfusions, less patients that require open     surgery and improved patient outcomes. The results of this study will help determine if this     treatment is effective at preventing the death of many people with ruptured abdominal aortic     aneurysms.   "
88638|NCT02125877|"     Assessed the new film-coated tablet formulation to the currently approved dispersible tablet     formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability,     satisfaction and compliance   "
88639|NCT02125864|"     The purpose of this study is to examine the plasma concentration of vascular endothelial     growth factor (VEGF) after standard treatment with one of the newest growth factor     inhibitors, aflibercept (Eylea).      Patients with exudative age-related macular degeneration (AMD) are treated today with     anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the eye     and a more powerful effect on the edema in the macula than previously used growth factor     inhibitors. This means that the disease can be controlled with fewer number of injections     into the eye and the investigators can therefore reduce the risk of complications associated     with this type of treatment.      It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in     patients with wet age-related macular degeneration is.   "
88640|NCT02125851|"     The purpose of this study is to determine if a xanthan gum or honey based budesonide slurry     exhibit comparable mucosal contact time to a budesonide/sucralose slurry in healthy adult     subjects.   "
88657|NCT02125630|"     A randomized trial evaluating resection of the primary breast tumor in women presenting with     de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully     selected patients presenting with stage IV breast cancer suggest that surgery on the primary     tumor may result in improved survival, but this remains unproven. The early results of our     ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women     with distant metastases at presentation who receive loco-regional treatment for intact     primary tumor compared with those who do not receive such treatment) showed that patients     with bone metastasis only have a trend toward improved survival with initial surgery.   "
88658|NCT02125617|"     The purpose of this study is to investigate cleavage products of the urokinase     plasminogenactivator receptor (uPAR) in plasma from patients with castration resistant     prostate cancer as a predictive marker of response to abiraterone.   "
88945|NCT02121834|"     This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This     study will evaluate the safety and how well the body tolerates LY3050258. It will last     approximately 14 weeks with a 2 week follow-up appointment after the last treatment with     study drug.   "
88641|NCT02125838|"     Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does     not increase the incidence of gastric aspiration, the failure of ventilation or the risk of     pulmonary aspiration . LM is presented as an alternative to endo tracheal tube (ETT) in     spontaneous or positive pressure ventilation (PPV) . LM has gained widespread popularity in     England for gynecological laparoscopic procedures. In addition in many previous studies LM     has been successfully shown to provide appropriate lung ventilation in laparoscopic surgical     interventions .Miller et al. compared the use of ETT, LM-P laparoscopic gynecological     interventions and identified advantages to LM use. The most important of these advantages was     that, contrary to tracheal tube techniques for laparoscopic surgeries, use of supraglottic     laryngeal devices or neuromuscular blocker agents (NBA) were not required during placement.     Thus for laparoscopic surgeries, compared with the ETT technique, without the need for     supraglottic laryngeal devices or muscular relaxants, it is easily placed and reduces the     time spent in the operating room.      Our aim; to compare the use of LM-S and ETT without neuromuscular agents for laparoscopic     gynecological intervention with positive pressure ventilation from a surgical viewpoint and     in terms of effect on ventilation parameters.      Secondary aim, comparison of airway morbidity with endotracheal intubation and supraglottic.   "
88642|NCT02125825|"     The objective is to assess a compact, portable, wireless movement disorder system with     continuous monitoring capabilities to detect and quantify the severity of levodopa-induced     dyskinesia in Parkinson's disease.   "
88643|NCT02125812|"     The adjunctive use of systemically administered antibiotics has been shown to provide a     better clinical outcome, particularly in terms of probing depth (PD) reduction and     attachment-level gain than SRP in subjects with Aggressive Periodontitis.      The overall objective of this study is to evaluate the clinical and microbiological efficacy     of moxifloxacin as an adjunct to scaling and root planing versus scaling and root planing     over placebo in the treatment of aggressive periodontitis.   "
88644|NCT02125799|"     High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and     efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks.     Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have     significant advantages in terms of access, patient acceptance and costs. In the present open     label trial the investigators intend to assess the effectiveness and acceptability of a novel     aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day).     For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at     baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well     as with computerized neurocognitive tests.   "
88645|NCT02125786|"     The primary purpose of this study is to investigate whether surgery and re-irradiation will     help treat ependymoma that has come back after initial treatment. The combined doses of the     first and second courses of radiation are higher than what is usual standard of care. The     investigators will study the effects and side effects of surgery and re-irradiation. They     will also evaluate and study tumor tissue and blood to learn more about the tumor and how it     does or does not respond to treatments and will use magnetic resonance imaging (MRI) and     positron emission tomography (PET) scans to see if they can predict tumor response and tumor     recurrence.      Participants will be followed for up to 5 years following enrollment. Evaluations during     radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other     evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and     every 6 months during the 4th and 5th year.   "
88646|NCT02125773|"     This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine     if providing high-risk subjects with a calculated risk score changes the likelihood of     pre-exposure prophylaxis (PrEP) uptake.   "
88647|NCT02125760|"     This study is divided for development in two complementary work packages justified by the     need to incorporate new strategies to optimize rehabilitation outcomes in stroke patients.     The general objectives are: 1) to determine the prevalence of respiratory muscle dysfunction     in stroke patients; 2) to identify the existence of a potential amino acid marker of     increased risk of muscle dysfunction after suffering a stroke; 3) to evaluate the     effectiveness of incorporating the respiratory muscle training as an innovative adjuvant     therapy in stroke rehabilitation program that may decrease the incidence of morbidity and     mortality in the medium and long term; and 4) to quantify the potential impact of respiratory     muscle training on the costs of care for stroke patients.   "
88648|NCT02125747|"     The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of     Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive     pulmonary disease.   "
88649|NCT02125734|"     The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to     show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung     function. Similarly, this study aims to evaluate patient preference after experiencing both     treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate     to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at     screening despite being treated with tiotropium   "
88670|NCT02125461|"     A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in     Patients with Stage III Unresectable Non-Small Cell Lung Cancer.   "
88671|NCT02125448|"     Rationale: For resectable esophageal cancer the standard therapy is 5 weeks of neoadjuvant     chemoradiotherapy (nCRT) followed by surgery 6-8 weeks afterwards. Surgery is performed     independent of the response to nCRT and is associated with substantial morbidity. A     pathological complete response (pCR) after nCRT is seen in 28-34% of patients. Pathological     non-responders (pNR) most probably do not benefit from nCRT but are exposed to its toxicity     and delay from surgical therapy inevitably occurs in this group. Early identification of     non-responders during nCRT would allow individualized decision making in continuation or     discontinuation of nCRT. Furthermore, a tool is desirable to accurately assess the treatment     response after nCRT to identify patients with a complete response. Studies in rectal cancer     reported that tumor resection could be omitted in patients with persisting clinical complete     response after 12 months. Also, in some esophageal cancer studies, complete responders in     surgical and non-surgical treatment groups had comparable overall survival. These findings     indicate the possibility to perform nCRT as sole treatment in patients with a complete     response. Conversely, if residual tumor is demonstrated, this will support the decision to     move to surgery.      Objective: Diagnostic study to assess the distinct and combined value of anatomical and     functional magnetic resonance imaging (MRI) and combined 18F-fluorodeoxyglucose positron     emission tomography and computed tomography (PET-CT) in the evaluation of treatment response     to nCRT for patients with esophageal cancer.      Study design: Multi-center diagnostic study investigating the value of MRI and PET-CT in the     imaging before, during and after nCRT for assessment of response to nCRT for resectable     esophageal cancer. Imaging response measurements will be compared with the histopathological     tumor regression grade (TRG) of the resection specimen as gold standard.      Study population: 50 patients (>18 years) presenting at the UMC Utrecht or M.D. Anderson     Cancer Center with resectable esophageal cancer, as determined by endoscopy and biopsy,     computed tomography (CT) and endoscopic ultrasonography (EUS), receiving nCRT prior to     surgery.      Procedure: In addition to the conventional diagnostic work-up for esophageal cancer including     a standard PET-CT before nCRT, two PET-CT scans will be performed during and after nCRT as     well as three MRI scans before, during and after nCRT at the same time points. The first MRI     (and standard-of-care PET-CT) scan session will be within the 6 weeks prior to the start of     nCRT. The second scan session will take place after 10-14 days after the start of nCRT. The     third and final scan session will be planned 1-2 weeks before surgery.      Main study parameters/endpoints: Determination of the distinct and combined diagnostic value     of anatomical and functional MRI and PET-CT in the evaluation of treatment response to nCRT     for patients with esophageal cancer. Important imaging parameters include apparent diffusion     coefficient (ADC) values, standardized uptake values (SUV) and volume measurements for the     different time points. The differences of these values between time points are of particular     interest (delta-ADC, delta-SUV, delta-volume). The sensitivity (%), specificity (%), negative     predictive value (%), positive predictive value (%), and accuracy (%) of the different     imaging parameters for correctly identifying histopathological complete response will be     calculated.   "
88659|NCT02125604|"     The primary objective of this study is to evaluate the effect of symptomatic therapies on     gastrointestinal-related events reported by participants with relapsing-remitting multiple     sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice     setting.      The secondary objectives of this study in this study population are as follows: to evaluate     gastrointestinal-related events requiring symptomatic therapy and the role of those therapies     over time; to evaluate gastrointestinal-related events that lead to a physician's decision to     manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related     events that lead to BG00012 discontinuation after the use of symptomatic therapy.   "
88660|NCT02125591|"     The purpose of this study is to evaluate improvement in balance after receiving physical     therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).   "
97947|NCT02004119|"     This study is an randomized double-blind placebo-controlled study to evaluate the efficacy     and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis.     Pharmacokinetics of KHK4577 will also be assessed.   "
88651|NCT02125708|"     The most common reason for preterm prelabor rupture of membrane (PPROM) is an ascendance of     infection. Moreover PPROM is one of the main risk factors for chorioamnionitis.      PPROM-related morbidity and mortality is higher in the neonate than in the mother, especially     in case of intrauterine inflammation. Of note, the most common biomarkers like CRP and     leucocytes are not specific for uterine infections and have not been proven useful in these     particular cases. Studies in intensive care medicine could show that there is a possible     correlation between onset of infection and body-core-temperature.      The OvulaRing® is a non-invasive thermometer measuring the intravaginal temperature every 5     minutes. It was originally invented to assess the moment of ovulation and optimize fertility.      Twenty patients with verified PPROM between gestation week 22 and 27 should be included in     this study. After gynecological and physical examination within verification of PPROM women     will be informed and invited to participate in this study. Subsequently informed consent will     be obtained and the OvulaRing® placed into the vaginal fornix.      The investigators aim to describe a possible correlation between core-temperature and common     biomarkers in clinical use for the detection of chorioamnionitis in patients with PPROM to     possibly assess the optimal time for delivery subsequently.   "
88652|NCT02125695|"     The main objectives of the study are: To determine if RNA recovery from tape harvesting     allows for the identification of a disease gene signature (e.g., interferon [IFN] signature     for lupus) or other biomarkers that may differentiate affected from normal or unaffected     skin; To determine if the lupus gene signature is differentially expressed in the epidermis     from active discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus     (SCLE) lesions when compared with unaffected skin from the same participants and from the     skin of healthy volunteers (HVs); To determine if the atopic dermatitis (AD) gene signature     is differentially expressed in the epidermis from active AD lesions when compared with     unaffected skin from the same participants and from the skin of HVs; and To correlate the     levels of transcripts of targeted genes in the skin by tape harvesting with those obtained     from the blood.   "
88653|NCT02125682|"     Atorvastatin is a statin that significantly decreases LDL level. At 10 mg/day, atorvastatin     increases HDL level by 4-5%. At 80 mg/day, atorvastatin does not increase HDL level. However,     atorvastatin is more protective at 80 mg/day than at 10 mg/day. This is due to a better     reduction in LDL level at 80 mg, but we also think that 80 mg/day of atorvastatin is superior     to 10 mg/day in improving the QUALITY of HDL, such as improving HDL particle number and     function (better anti-oxydant activity)   "
88654|NCT02125669|"     Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic     approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking     due to inconsistent design of available studies. The purpose of this study is to evaluate the     PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk     anatomical sites in an evidence based study setting.   "
88655|NCT02125656|"     Sleep is an essential biological process for life and great value to functions such as     learning, memory processing , cell and brain repair. Recently, new evidence points to the     relationship between lack of sleep and carbohydrate metabolism , establishing a framework for     insulin resistance observed in studies with restriction and sleep deprivation on several     nights and in a single night . To reverse this process , one of the most effective strategies     is physical exercise and part listed in the literature as a non-pharmacological tool for     prevention and health promotion , as well as in the treatment of some diseases . However ,     the pace of modern society causes people to practice less physical exercise , lack of time     being the main reason . In this scenario, the High Intensity Interval Training ( HIIT )     emerges as a powerful strategy that induces major changes optimizing the time spent on such     activity. Considering the benefits of this mode , the purpose of this study is to investigate     the effects of high-intensity interval training in the context of insulin resistance observed     during sleep deprivation. Will be recruited 20 male volunteers, aged between 18 and 35 years     old, healthy, with normal sleep duration equivalent to 7-8 hours / night, not smoking and     regular eating habits. They will be submitted to a protocol of 6 sessions of high-intensity     interval training for two weeks, and since the end period, sleep normally, or be deprived of     sleep for 24 hours. Biochemical (thyroid hormones, cortisol, glucagon, free fatty acid,     cholesterol, glucose and insulin) will be undertaken as well as evaluation of body     composition by plethysmography, basal metabolic rate by indirect calorimetry and insulin     sensitivity through Oral Glucose Tolerance Test (OGTT) before and after the training period.   "
88656|NCT02125643|"     We have hypothesized: 1) Caffeine will increase maximal voluntary strength compared to     placebo in undamaged muscle. 2) Caffeine will increase muscle activation compared to placebo     in undamaged muscle. 3) Caffeine will enhance spinal excitability (indicated by an enhanced     H-reflex) compared to placebo in undamaged muscle. 4) Caffeine will raise the pressure-pain     threshold (indicating decreased pain sensitivity) in the calf muscle compared to placebo in     undamaged muscle. 5) Caffeine will reduce the amount of low-frequency fatigue, indicated by     an enhanced 20-100 hertz strength ratio, compared to placebo in undamaged muscle. 6) Caffeine     will increase maximal voluntary strength compared to placebo in damaged muscle. 7) Caffeine     will increase muscle activation compared to placebo in damaged muscle. 8) Caffeine will     enhance spinal excitability (indicated by an enhanced H-reflex) compared to placebo in     damaged muscle. 9) Caffeine will raise the pressure-pain threshold (indicating decreased pain     sensitivity) in the calf muscle compared to placebo in damaged muscle. 10) Caffeine will     reduce the amount of low-frequency fatigue, indicated by an enhanced 20-100 hertz strength     ratio, compared to placebo in damaged muscle.      The proposed research will determine the effects of a 5mg/kg body weight dose of caffeine on     muscular strength, activation, H-reflex function, and excitation-contraction coupling before     and after exercise-induced muscle damage. The long term objectives are to gain a better     understanding of caffeine and its affects following exercise-induced muscle damage allowing     us to understand how caffeine is mechanistically interacting with functions of the body.   "
88672|NCT02125435|"     The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK)     of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female     subjects and to evaluate the pharmacodynamics of ASP2408.   "
88673|NCT02125422|"     Transcranial direct current stimulation is a tool to modulate cortical excitability.   "
88662|NCT02125565|"     Arterial Blood Gas (ABG) sampling is a common procedure in all hospitals worldwide. Often,     ABG samples are obtain from inserting a needle into the radial artery at the wrist - this     procedure is often painful and dreaded by patients. Therefore, some doctors use local     anaesthetic but others argue that it makes the procedure more difficult and causes pain     itself. The use of local anaesthetic costs approximately £1 per injection and when thousands     of ABGs are performed per month, the cost is easily appreciable. However, there is no good     research to guide clinicians in the use or omission of local anaesthetic for ABGs. This is     the first randomised clinical trial to assess the efficacy of injected local anaesthetic on     the perceived pain of radial artery puncture.   "
88663|NCT02125552|"     The primary objective is to determine whether the use of ultrasound guidance compared to     standard IV access improves the proportion of successful IV placement on a first attempt for     children in a pediatric emergency department who have predicted difficult access by a     validated score. Secondary objectives include determining whether ultrasound-guided IV access     lowers the overall number of IV attempts and/or reduces time to IV access. The investigators     will also examine the duration of IV access and any complications related to IV access in     both the traditional and ultrasound guided IV access group.   "
88664|NCT02125539|"     The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my     Journey program for adolescents receiving treatment in an outpatient substance abuse center.      The primary hypotheses are that, relative to the control condition, Navigating my Journey     will be associated with significantly higher motivation, higher self-efficacy, improved     relapse coping skills, and lower substance use. The secondary hypotheses are that, relative     to the control condition, Navigating my Journey will be associated with increased therapeutic     alliances with counselors.   "
88665|NCT02125526|"     Patients presenting with large myocardial infarction and signs of persistent ischemia after     successful percutaneous coronary intervention, have a poor prognosis with respect to outcome     and development of heart failure in the future.      The hypothesis of this study is that in patients in whom persistent ischemia is present, use     of intra-aortic balloon pump will be beneficial and improve outcome.   "
88666|NCT02125513|"     The purpose of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead     to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant     chemotherapy in patients with epithelial ovarian cancer, fallopian tube cancer or primary     peritoneal cancer.   "
88667|NCT02125500|"     Aim of the study is to assess the efficacy and safety of 24 weeks of oral     Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection     and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated     interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.   "
88668|NCT02125487|"     The purpose of this study is to determine whether the use of hybrid simulation of the breast     are more effective in teaching CBE technique and culturally sensitive doctor-patient     communication skills to medical students than the traditional method.   "
88669|NCT02125474|"     Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing     number of new cases reported in the annual statistics of the Instituto Nacional de     Cancerología (INC). The majority are advanced-stage presentations with limited chances of a     complete surgical resection of the primary tumor, a clinical scenario where medical treatment     options are also limited. In view of the characteristically defined expression of peptide     receptors in WDNETs, radioactive molecular probes to target specific cellular receptors have     been designed using radioisotopes with short range of penetration in tissues. We have     designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic     efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in     three separate doses to patients with inoperable progressive WDNET. Selected patients     matching inclusion criteria will be enrolled at the INC's Section of Endocrinology. Tumor     response, treatment safety (side effects) and survival will be appraised. Data from clinical,     biochemical and imaging follow-up will be periodically registered during treatment and until     two years after the last infusion of 177Lu- DOTATATE. This phase II trial is justified     because despite the fact that many preclinical and clinical studies have showed the potential     usefulness of this novel palliative approach to treat patients with advanced-stage WDNETs     there is a paucity of vigorous results to establish its efficacy as first-line treatment.   "
88674|NCT02125409|"     In a preliminary study in healthy subjects, the investigators determined the pharmacokinetic     and pharmacodynamic of enteric-coated acetylsalicylic acid (ASA) (Adiro 100 mg, Bayer), and     the variability (coefficient of variation), accuracy and precision of a novel biomarker of     ASA action, i.e., quantification of the extent of COX-1 acetylation at serine-529, using a     stable isotope dilution liquid chromatography multiple reaction monitoring/mass spectrometry     (LC-MS) technique.      Now, the investigators will perform a clinical study in individuals undergoing Colorectal     cancer (CRC) to validate the hypothesis that that low-dose ASA given once daily is acting     primarily by selectively acetylating platelet COX-1 and suppressing its activity throughout     the 24-hour dosing interval. In contrast, it is expected that the inhibitory effect on     extra-platelet sources of COX-1 will be short-lasting, if any, affecting only partially     COX-1, and this effect will be completely reversed at 24 hours after dosing. This is an     important point which will strengthen the platelet hypothesis underpinning the apparent     adequacy of a 24-hour dosing interval of ASA administration for the anticancer effect     detected in cardiovascular trials.      These patients will be stratified into individuals with adenomas/carcinomas (20 to 30%) and     patients without clinically detected adenomas/carcinomas (about 70 to 80%).   "
88675|NCT02125396|"     Despite advances in our understanding of hepatocellular carcinoma (HCC) and its diagnosis,     the prognosis for patients with HCC remains disheartening, due to a high recurrence rate and     frequent intrahepatic metastasis. Various therapies for use after hepatic resection have been     reported, but they are associated with adverse side effects or they fail to improve overall     survival. Nowadays, adjuvant transarterial chemoembolization (TACE) is recommended as the     most effective therapy for postoperative HCC. And the indication is patients with risk     factors of recurrence. While more and more prospective studies revealed that radiotherapy is     effective for advanced HCC. And the side effects of radiotherapy are controlled. Until now,     no prospective or retrospective study compared the efficacy of adjuvant TACE and radiotherapy     for postoperative HCC.   "
88677|NCT02125370|"     This study is largely a qualitative study with a small survey component. The aim of the     survey would be to gain a quantitative perspective of how women use NRT after this has been     prescribed by stop smoking services (SSS). The aim of the qualitative study would be to     enhance knowledge of pregnant smoker's views and attitudes about their experiences of using     NRT and in particular to understand why pregnant women who start using NRT often discontinue     this early or do not use the medication as it is prescribed. This information is important     for a number of reasons; firstly it will help health professionals and researchers gain an in     depth understanding about how women experience using NRT, which may be used to help devise     strategies for encouraging better adherence and which could be used in future clinical trials     to gain a clearer understanding as to whether or not NRT is effective in pregnancy.   "
88678|NCT02125357|"     This study is being offered to patients who have castrate-resistant (also known as     hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the     prostate area to other parts of the body.      The purpose of this study is to evaluate the effects of sequencing hormonal therapies     (abiraterone acetate and enzalutamide) and to assess treatment efficacy of these two agents.   "
88679|NCT02125344|"     Two regimen are currently considered to have highest efficacy for patients with high-risk     early stage breast cancer: sequential treatment of high dose epirubicin, taxane, and     cyclophosphamide concomitantly with a dual HER2-blockade, and weekly treatment with     paclitaxel/non-pegylated liposomal doxorubicin with dual HER2-blockade or carboplatin. The     aim of the GeparOcto study is to compare those two regimen/strategies.      Both regimens are myelosuppressive with a significant incidence of chemotherapy induced     anaemia.      The second aim of the GeparOcto study is therefore to compare the use of parental ferric     carboxymaltose versus physician's choice for the treatment of chemotherapy-induced anemia in     patients with iron deficiency.   "
88680|NCT02125331|"     This study is required to demonstrate that the non-invasive blood pressure (NIBP) measurement     algorithms on two commercially available multifunction hemodynamic acquisition modules, the     Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm (PDM-SUPERSTAT)     and the Patient Side Module (PSM) equipped with Datex-Ohmeda GE algorithm     (PSM-Datex-Ohmeda), provide accurate NIBP measurements in accordance with the guidelines     provided by the most recent International Organization for Standardization (ISO)     81060-2:2013.      Notably, the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and     this study is being conducted in accordance with the most recent applicable standards.      This study will assess neonate, infant, children, pediatric, adolescent, and adult patients     as well as adults with chronic atrial fibrillation in a population that requires non-emergent     heart catheterization.      This is a study conducted to satisfy both standards for two NIBP devices and, as such, does     not require a statistical hypothesis.   "
88681|NCT02125318|"     Anagrelide is a drug that has been shown to slow down how fast platelets are made in the bone     marrow, and has been approved by the FDA for treating high platelets counts in patients with     bone marrow disorders.      Anagrelide Controlled Release (CR) is a new preparation of anagrelide that is made to     dissolve more slowly than currently marketed versions of this drug. Because of this, the     anagrelide is taken up into the blood more slowly. Researchers think that this slower release     of the drug could help to lower side effects that might be caused by high blood levels when     the drug dissolves as quickly as it does with the currently marketed product.      The main purposes of this study are to see how well Anagrelide CR can control platelet counts     in patients with high platelet levels, to see what kind of side effects it causes, and to     measure blood levels of the drug.   "
88682|NCT02125305|"     This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral     administration in healthy elderly male volunteers.   "
88683|NCT02125292|"     The purpose of this study is to compare the palatability of SHP429 capsule contents delivered     via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into     a cup and administered with water).   "
88684|NCT02125279|"     The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of     treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat     pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque     psoriasis.   "
88690|NCT02125201|"     Neonatal intensive care unit patients undergoes many painful procedures during their     hospitalization. Effective pain control in such procedures as intubation, catheterization,     central line insertion, chest tube insertion, etc. is an important part of treatment. Opioids     administration is a common practice for acute pain prevention. Fentanyl is the preferred     opioid due to it rapid onset and short duration of action.      Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal     administration is practiced for about 20 years. A rich vascular supply in a nose provides     rapid absorption of the drug. This uninvasive root is now popular for pain prevention and     treatment. There are about 20 trials with intranasal fentanyl administration to children from     6 month old to 18 years. The investigators did not find information about this way of     administration in neonates.      In our pilot study the investigators want to check if intranasal administration of fentanyl     is safe and effective in pain prevention in term and preterm neonates during invasive     procedures and to compare it with intravenous route of administration.   "
88691|NCT02125188|"     Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons     and anesthesiologists despite several measures available for improving the surgical field.     This study was conducted to evaluate the effect of desmopressin on blood loss and the quality     of the surgical field in FESS.   "
88692|NCT02125175|"     High dose radiotherapy is a very effective treatment for prostate cancer. However, there is     an increased risk of side effects compared to lower dose radiotherapy. This study will     investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a     high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose     to the rest of the prostate. This may improve control of the cancer without increasing the     side effects. The radiotherapy is given in 20 doses, called fractions.   "
88693|NCT02125162|"     The purpose of the study is to compare how the body takes up and then eliminates the study     drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule.     This study will also evaluate whether food has any effect on how the body takes up BCX4161.   "
88701|NCT02125058|"     Rationale:      Skin cancer is common in Caucasians and often exists on sun-exposed areas, such as the face.     Treatment of choice is mostly excision and result in an irreversible scar. As the incidence     of skin cancer is rising, also among young people, it is important to obtain a good cosmetic     outcome after treatment. It is believed that the type of closure of the wound after excision     can influence the cosmetic result. Currently, primary closure of the excision can occur by     transcutaneous (TC) or intracutaneous (IC) suturing. Both techniques are widely used among     dermatologists and plastic surgeons and the choice is mainly dependent on the preference of     the physician. Research comparing the cosmetic result of both techniques in the craniofacial     area is lacking.      Objective:      Evaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in     the craniofacial area.      Study design:      A randomized controlled single-blinded multi-center trial.      Study population:      Patients older than 18 years, with craniofacial skin tumor receiving surgery followed by     primary closure at the department of Dermatology and Plastic Surgery of the Maastricht     University Medical Centre, the department of Dermatology of Catharina hospital Eindhoven and     the department of Plastic surgery of Orbis Medical Centre Sittard.      Intervention:      Excision of the tumor followed by IC sutures or TC sutures      Main study endpoints:      Cosmetic result measured on the Patient and Observer Scar Assessment Scale (POSAS) by the     patient and the researcher 12 months after surgery.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      All patients who participate have an indication for excision and will be assigned to one of     the suture techniques. Both techniques are widely used in the regular patient care.     Therefore, no extra risks are associated with it.      Patients will be asked to visit the hospital 3 months and 1 year following treatment, at     which point a questionnaire will be filled in and the redness of the scar will be measured by     means of non-invasive techniques. In addition, patients will be asked to apply a sunscreen on     the scar daily during the first three months of follow-up.   "
88711|NCT02124928|"     The aim of this study is to investigate the association of sonographic and histological     features of the plaque among each other and with biomarkers of cardiovascular risk. The     predictive value of these factors concerning the long-term clinical outcome after carotid     endarterectomy will also be assessed. This may help to improve the identification of patients     with carotid artery stenosis who will benefit most from carotid endarterectomy. The     investigators major hypothesis is that the morphology of carotid plaques is associated with     objectifiable sonographic parameters, in particular with the greyscale median. Second, the     investigators hypothesize that sonographic and histological plaque morphology are associated     with certain biomarkers of cardiovascular risk. Identification of 'vulnerable plaques' on the     basis of a peripheral blood draw and a sonographic investigation may enable the treating     physician to focus resources on patients who will benefit most form therapeutic interventions     for primary prevention of ischemic stroke.   "
88712|NCT02124915|"     The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis     use, perceived comfort, and satisfaction with the prosthesis are affected by size of the     prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again     after wearing a slightly oversized socket for 1 month.   "
88702|NCT02125045|"     Background. The antioxidant systems are the main endogenous defense against free radicals,     and glutathione seems to play an important role in this mechanism. Reduced glutathione enters     into the detoxification processes of endogenous products, such as hydro- and lipoperoxides     and exogenous compounds such as pollutants, heavy metals and some drugs. Changes in GSH     homeostasis have been implicated in the etiology and progression of several diseases.     Supplementation of GSH may improve the endogenous antioxidant defense and may contribute to     decrease of oxidants tissue damage a pathophysiologic mechanism of many acute and chronic     diseases.      However, the efficacy of GSH treatment seems to be closely related to the degree of its     absorption and to the increase of its concentrations in plasma and cells. Previous studies of     oral GSH administration in healthy volunteers or in patients failed to find any effect in     terms of oxidative stress reduction and/or disease improvement because the GSH is quickly     catabolized by gastrointestinal tract. We have recently observed (preliminary data) that a     new sublingual formulation of L-GSH (OXITION), produced by PH&T S.r.l., is able to increase     erythrocyte and plasma GSH levels in healthy volunteers bypassing gastrointestinal barrier.      Objectives. The primary study objective is to determine whether medium term (4 weeks) of     sublingual L-GSH supplementation to a population with smoking habit and/or arterial     hypertension may result in improved endothelial function as assessed by the flow mediated     dilation (FMD) technique versus placebo. FMD is a surrogate end point validated in the     literature as prognostic predictor for major cardiovascular events in patients with     endothelial dysfunction. Secondary study objectives are to determine differences between the     2 treatment in terms of oxidative stress markers.      Methods. This is a phase 3, double-blind, randomized, placebo-controlled, cross-over study     performed in only one centre. Sixteen male subjects, aged ≥ 40 and ≤ 60 years, with smoking     habit and/or hypertension defined as arterial blood pressure ≥ 140 and/or 90 mmHg or in     anti-hypertensive treatment, will be enrolled and randomized to receive sublingual L-GSH (100     mg twice a day) or placebo according to a double-blind cross-over design for 4 weeks with a     3-week wash-out period between the two treatments. Baseline and at the end of each treatment     period, FMD assessment and blood samples collection for routine (creatinine, urea, AST, ALT     GGT, total cholesterol, HDL, LDL, triglycerides, fasting glucose) and specific (aminothiols,     nitrotyrosine, malondialdehyde, 8-hydroxy-deoxyguanine) biochemical determination will be     performed.   "
88704|NCT02125019|"     Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.   "
88705|NCT02125006|"     Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best     medical treatment, some survivors continue to experience disabling pain. It is     well-established that an interdisciplinary approach is key to the treatment of some types of     chronic pain, but little research has been done on the effectiveness of interdisciplinary     treatments for cancer survivors with chronic neuropathic pain. The investigators will     evaluate the effectiveness of an interdisciplinary approach combining medical treatment and     mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life     among breast cancer survivors with chronic neuropathic pain. The investigators will also     evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of     stress and immune function, cognitive function, as well as brain structure and function.      The investigators will recruit 108 adult women survivors of breast cancer living with chronic     neuropathic pain. All will have their medical treatment optimized by a pain medicine     specialist before being randomly assigned to either an 8-week group MBSR program or a     wait-list. All participants will complete self-report questionnaires, provide a hair sample     for cortisol measurements and a blood sample to measure several markers of immune function at     four different time points: before medical treatment, after medical treatment and before     randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month     follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic     resonance imaging before and after participation in MBSR.      The primary outcome is pain interference. The investigators will compare the proportion of     participants who report reduced pain-related disability, as measured by the Brief Pain     Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month     follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain     Inventory Interference score) in the interdisciplinary program in comparison to medical     treatment alone.   "
88706|NCT02124993|"     This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered     food preferences before and after surgery.   "
88707|NCT02124980|"     If shown to be effective, the Recovery Line would provide an inexpensive, transportable, and     easy to use treatment to improve substance abuse outcomes for medication assisted treatment.     Given the high costs of relapse and continued drug use, improvement of treatment outcomes     would provide substantial health, economic, and societal benefits.   "
88729|NCT02124694|"     This study will pilot an intervention that combines group Interpersonal Psychotherapy (IPT),     an empirically-supported treatment, and the Historical Trauma and Unresolved Grief     Intervention (HTUG), a Tribal Best Practice for American Indians. HTUG focuses on grief,     depression, and trauma response resolution related to collective massive group trauma across     generations, including the lifespan, for American Indians. We anticipate more positive     responses to, and patient engagement in, the combined HTUG/IPT intervention than to IPT Only.   "
88708|NCT02124967|"     South Asian (SA) women living in Ontario have a higher risk of developing type 2 diabetes and     coronary heart disease (CHD) compared to the general population. Various explanations for     these differences have been established, one of which is based on low levels of physical     activity in people of SA origin, particularly in Muslim women.      This pilot trial will test the feasibility, acceptability and effectiveness of a Mosque-based     exercise and educational intervention designed for SA Muslim women.        1. What is the feasibility of a mosque-based intervention to promote physical activity that          is culturally and gender sensitive to South Asian Muslim women?        2. What is the acceptability of a mosque-based intervention to promote physical activity          that is culturally and gender sensitive to South Asian Muslim women?        3. What is the effectiveness of a mosque-based intervention to promote physical activity          that is culturally and gender sensitive to South Asian Muslim women?   "
88709|NCT02124954|"     A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and     rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to     see if there are any potential drug interactions that might affect patients in future     studies. The study will examine whether co-administration of TA-8995 affects the     pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).   "
88710|NCT02124941|"     Given prior evidence of reduced resting-state glucose uptake in prefrontal cortex (PFC) as     measured by [18F]-FDG PET (Volkow 1992, 1993) and direct neurometabolic coupling of cortical     glucose oxidation and glutamate transmission, we hypothesize that [13C]-MRS measures of VTCA     and VCYC will be reduced in individuals abstinent from cocaine as compared to HCs. We will     also explicitly explore potential relationships between VCYC and neurocognitive tests of PFC     function and clinical outcomes (i.e., measures of relapse at 90-days outpatient follow-up).     In addition to assessing resting-state glucose uptake in the PFC, we will explore whether     open-label administration of either of three different pharmacological treatments (N-acetyl     cysteine, riluzole, or pentoxifylline) increases VCYC, in cocaine users (CU) in comparison to     their abstinence baseline.   "
88713|NCT02124902|"     This is a single arm open label phase II study in women with clinical stage 2 or 3 triple     negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete     response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived     xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.   "
88714|NCT02124889|"     Additional micronutrient supplementation is required due to the changes in the     gastrointestinal anatomy and physiology following bariatric surgery along with decreased     dietary intake and rapid weight loss. Good adherence to post-operative vitamins is essential     to maintain healthy vitamin levels in the body following bariatric surgery. The hypothesis of     this study is that patients receiving a weekly survey intervention will have better adherence     to post-operative vitamins than a control group not receiving the survey.   "
88715|NCT02124876|"     The purpose of this study is to quantify residual limb fluid volume changes between morning     and afternoon hours, and to determine if fluid volume change is correlated with activity.   "
88716|NCT02124863|"     The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation (     airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from     0 to 12 months.   "
88717|NCT02124850|"     Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who     will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab,     motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before     surgery. The primary objective of the study is to determine the extent to which the     administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and     nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor     infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An     exploratory objective of the study is to assess whether modulation of biomarkers as described     above can predict anti-tumor response.   "
88718|NCT02124837|"     The objective of this research project is to understand and to improve workers´ recovery from     work stress. Although recovery during lunch breaks is the most common within-workday break,     it has received only minor research attention. Therefore, we will study whether lunch breaks     including a relaxation session or exposure to nature have more favorable outcomes than     usually spent lunch breaks concerning: a) recovery processes, b) health, c) well-being, d)     job performance and e) creativity. We approach recovery by combining the theoretical     frameworks of work and environmental psychology.   "
88719|NCT02124824|"     Heart disease is the leading cause of death in the United States, accounting for one in every     four deaths in 2010 and costing over $300 billion annually in health care, medication, and     lost productivity. Heart failure (HF), a clinical syndrome that develops as a consequence of     heart disease, is characterized by the worsening of symptoms, such as dyspnea and fatigue,     upon exertion, collectively defined as exercise intolerance. Surprisingly, exercise     intolerance does not correlate with the degree of cardiac contractile (ventricular)     dysfunction, suggesting that changes in the peripheral circulation may be to blame for     exercise intolerance in this cohort. Though there are a host of factors that may contribute     to this impairment, disease-related increases in circulating endothelin-1 (ET-1) may be a     significant factor in the sequelae of exercise intolerance in HF. Thus, the overall purpose     of this Small Projects in Rehabilitation Research (SPiRE) proposal is to explore the     contribution of ET-1 to chronic vasoconstriction in HF patients, and to examine whether     inhibition of this pathway could improve vasodilatory ability, and thus exercise tolerance,     in Veterans with HF.   "
88730|NCT02124681|"     Current options to treat insulin resistance in diabetes are fairly limited. For this reason,     novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ)     has poorly understood effects on blood sugar metabolism. In this study, the investigators     will examine the mechanisms by which this drug affects glucose metabolism and which cells are     affected. Findings emanating from this project will help establish whether HCQ may be a     viable treatment for disorders of glucose metabolism.   "
88731|NCT02124668|"     The purpose of this study is to monitor the safety of enzalutamide in patients with     progressive castration-resistant prostate cancer previously treated with docetaxel-based     chemotherapy.   "
88720|NCT02124811|"     Schizophrenia is a major mental illness characterized by a variety of different symptoms     including hallucinations, paranoia, difficulties with formulating and expressing thoughts,     feelings similar to depression, and problems with cognitive processes. Individuals with     schizophrenia are usually treated with a class of medications called anti-psychotics, which     typically help alleviate some of the symptoms of the disorder. In general, anti-psychotic     medications do not completely cure the disorder, and many patients are left with some degree     of ongoing symptoms. Furthermore, it is estimated that 20-30% of individuals with     schizophrenia are considered treatment refractory or resistant and do not respond to     anti-psychotic medications. The Food and Drug Administration has approved one antipsychotic     medication for use in patients who are considered to have treatment resistant schizophrenia     (TRS). This medication, clozapine, has been shown to be beneficial for patients with TRS,     though as many as 40-70% of patients fail to respond or are partially responsive to treatment     with clozapine. In an extensive search of the medical and psychiatric literature, we have     been impressed by the potential of minocycline, a tetracycline antibiotic, as an adjunctive     therapy in patients with schizophrenia based on its reported neuroprotective and     anti-inflammatory effects. It is a fairly inexpensive drug, well tolerated, and two     randomized clinical trials have demonstrated favorable results in early-phase schizophrenia.     Only one case series with two patients has investigated minocycline in patients with     schizophrenia on clozapine. Minocycline is also an interesting medication for augmentation     with clozapine, as we are interested in previous findings of increased inflammation in the     brains of patients with schizophrenia and the potential role of inflammation in treatment     resistant schizophrenia. Though there are many markers of increased inflammation in the     brain, for this current study, we are interested in a general marker of inflammation called     C-Reactive Protein (CRP). We hypothesize that some patients may have increased levels of     inflammation in the brain, as measured by the CRP level (drawn from peripheral blood), and     that those patients with increased levels of CRP may respond better to augmentation with     minocycline. The proposed pilot study will compare minocycline augmentation with clozapine in     individuals with high vs low inflammation as measured by CRP. We hypothesize that minocycline     will be well tolerated and will result in an improvement in the symptoms of schizophrenia,     cognition, as well as improve the quality of life for patients preferentially in patients     with high CRPs. We plan to use a variety of different scales to measure improvement in the     varying symptoms of schizophrenia as well as cognitive function, which will be administered     to patients at three week intervals for a total study time of twelve weeks. We hypothesize     that minocycline could prove to be an effective, well tolerated, and inexpensive medication     for treatment resistant patients with schizophrenia whom have particular difficulties with     social interactions, obtaining and maintaining employment, and overall quality of life.     Furthermore, we hypothesize that the data obtained in this study will contribute to the     ongoing exploration of the role of inflammation in the brain of patients with schizophrenia     and help understand and target the role of various inflammatory markers in the     pathophysiology and treatment of treatment resistant schizophrenia.   "
88721|NCT02124798|"     The primary objective of this study is to assess the suitability of the autoinjector for     self-administration of belimumab by subjects with SLE in real-life conditions. The study will     assess the use of the autoinjector inside the clinic setting and outside the clinic setting.     The study will also assess the safety and tolerability of belimumab administered     subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into the     thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return for a     follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be assessed     by the investigators for success based on direct observation and/or the subject diary. A     total of 118 subjects (treated with at least one dose of study drug) are planned to be     enrolled in this study.   "
88722|NCT02124785|"     The purpose of this study is to assess the long-term persistence of immunity to hepatitis A     in adults who were vaccinated 21-25 years earlier with hepatitis A vaccine, Havrix®.   "
88751|NCT02124382|"     Evaluate the outcome of pediatric living donor liver transplantation (LDLT) regarding portal     vein reconstruction, ABO-compatibility and impact of maternal donation on graft acceptance.   "
88839|NCT02123225|"     The goal of this study is to determine if the investigators can use the STOP-BANG score to     identify those patients at risk for worsening Obstructive Sleep Apnea (OSA) symptoms in the     early postoperative period after major surgery.      Hypotheses:        1. - Postoperative sleep apnea parameters will be worse when compared to baseline in          patients with higher scores on the STOP-BANG.        2. - A higher STOP-BANG score will be predictive of worsening sleep apnea parameters in          patients undergoing Total Knee Arthroscopy (TKA).   "
88724|NCT02124759|"     The purpose of this study is to determine the effect of high fat consumption on the     intestinal microbiome, metabolic endotoxemia, and insulin action, in lean normal glucose     tolerant subjects.   "
88725|NCT02124746|"     This open-label study is to determine the long-term safety and tolerability of momelotinib in     previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia     vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF),     polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved     stable disease or better with momelotinib treatment while enrolled in a previous clinical     trial.   "
88726|NCT02124733|"     This study is being done to compare a new, continuous illumination regimen of ALA-PDT     (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic     keratoses. The hypothesis is that the continuous illumination approach will be less painful,     but equally efficacious, as the old regimen.   "
88727|NCT02124720|"     Nearly all children with autism spectrum disorders engage in non-functional repetitive vocal     and motor behaviours commonly referred to as stereotypy. These repetitive behaviours may     considerably interfere with the child's daily functioning, learning, and social inclusion. As     such, stereotypy generally has a negative impact on the child and family's health and quality     of life. Several behavioural interventions have been developed to reduce engagement in     stereotypy in children with autism spectrum disorders, but the limited number of specialists     available, the long waiting lists associated with public health services in Canada, and the     high costs of private services have considerably restricted accessibility. One potential     solution to the limited availability and high costs of services is using a mobile application     to recommend, teach, and monitor interventions designed to reduce engagement in stereotypy.     To this end, the purpose of the study is to evaluate the effects of the iSTIM (i.e.,     individualized Stereotypy Treatment Integrated Modules), a mobile application designed to     assist parents in reducing stereotypy in children with autism spectrum disorders.     Specifically, we will assess whether the iSTIM correctly estimates the frequency or duration     of stereotypy, offers suggestions consistent with recommended clinical practices, effectively     reduces engagement in stereotypy, and is socially acceptable, safe, and easy to use for     parents of children with autism spectrum disorders. The results of the study will allow us to     determine whether the mobile application may be used to treat this core symptom in children     with autism spectrum disorders, which could potentially reduce waiting times and costs of     providing health services to this population. By reducing engagement in stereotypy, the iSTIM     may also promote and facilitate the social participation as well as improve the quality of     life and health of children with autism spectrum disorders and their families.   "
88728|NCT02124707|"     This is a non-randomized, open-label phase II trial of 38 patients with recurrent or     metastatic SCCHN. Patients must have ECOG performance status of 0-1 with good organ function     and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab.     Following assessment of response, the treating physician at their discretion may continue to     treat with weekly cetuximab as maintenance until disease progression. The study is designed     to evaluate whether this regimen improves median overall survival (OS) as compared to an     historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is     currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen     options are highly toxic, inconvenient and resource intensive. Our study regimen has been     used extensively for induction therapy and off-protocol in palliative care, but treatment     outcomes have yet to be defined by a clinical trial.   "
88946|NCT02121821|"     The study aims to assess the effects of the SMS Mother Reminder system on use of health care     in Uganda. A secondary aim of the study is to determine the behavioral factors and     cost-effectiveness, as well as test the usability of the SMS Mother Reminder in Uganda.   "
88752|NCT02124369|"     Pancreatic cancer is difficult to treat, and even in a situation where an operation can be     performed to remove the cancer, the disease can unfortunately come back soon afterwards. When     pancreatic cancer is more advanced, the outcomes are even less positive. Recently, a large     international study showed that combining a chemotherapy drug that is standard for treating     pancreatic cancer, called gemcitabine with a new chemotherapy drug called Abraxane was more     effective than gemcitabine alone for patients with advanced pancreatic cancer.      The purpose of this study is to determine whether this combination of gemcitabine and     Abraxane can shrink a pancreatic cancer that is not thought to be operable enough to enable     it to be removed by surgery. It is hoped that in this way, the treatment may improve the     outcome. In addition, in this study we would like to analyse the appearances of the tumour     using imaging, and collect blood and tumour samples to try to confirm laboratory research     that has been carried out with this treatment.   "
88732|NCT02124655|"     The accumulation and maturation of oral biofilm in the gingival margin is widely recognised     to be the primary aetiological factor in the development of chronic gingivitis. Based on this     association, the current treatment of gingivitis is focused on biofilm disruption, which will     normally include mechanical processes, both professionally and at home. However, for     patients, it is not easy to achieve a proper level of plaque control. The efficient plaque     control techniques are very time consuming and require a special motivation and skills for     their optimum use. It was at this point where mouthwashes become important, due to the fact     that they include diverse types of antimicrobial agents to complement the results of     mechanical oral hygiene measures.      Chlorhexidine is considered the gold standard of oral antiseptics; nevertheless it has not     been recommended for long periods of time due to its well-known secondary effects. All of     these inconveniences have limited its acceptability among dental professionals and users; in     contrast, however, are the exceptional antiseptic properties, promoting the interest of     researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in     their formulation have received a lot of attention. Their antiplaque activity has been     demonstrated in numerous clinical studies, in which they were used in conjunction with     mechanical oral hygiene measures.      In order to achieve a better understanding of the clinical effects that antimicrobial agents     produce in the interior of the biofilm, it is necessary to apply a methodology in which the     biofilm grows directly in the interior of the oral cavity but its three dimensional structure     is not distorted by manipulation.      The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents     (essential oils formulation and 0.2% chlorhexidine) in the short term with a posterior     analysis on non-destructured biofilm with Confocal Laser Scanning Microscope combined with     fluorescence staining.   "
88733|NCT02124642|"     The proposed study is a double-blind randomized controlled trial in healthy pregnant women     (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery     clinic (ARMC).      The primary goal of the proposed study is to determine relative changes in blood folate and     DNA methylation levels in response to 2 different supplemental doses of folic acid one of     which will provide the Institute of Medicine's recommended folate intake for pregnant women     and the second will provide a higher dose as routinely taken by pregnant women in     over-the-counter prenatal supplements.      The specific aims of the study are:        1. to compare maternal serum and red blood cell (RBC) folate levels and % change in women          taking either 400 or 800 mcg/day of supplemental folic acid from the first prenatal          visit (< 10 weeks) through delivery;        2. to compare the infant's cord blood folate levels in response to different maternal folic          acid intakes (400 mcg/d vs 800 mcg/d);        3. to determine relative differences in the levels of oxidized folic acid in maternal and          infant blood in response to 400 or 800 mcg/d folic acid dose, and        4. to determine genome wide and gene specific DNA methylation response in pregnant women          receiving prenatal supplements containing either 400 or 800 mcg folic acid per day   "
88734|NCT02124616|"     Our aim is to establish multi-center national Egyptian database of information for inherited     and acquired neuromuscular diseases in infants and children from 0 to 18 years of age.   "
88735|NCT02124603|"     The purpose of the present study is to elucidate the spectrum of ocular flora and their     antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.   "
88736|NCT02124590|"     This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke     Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the     effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin     sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise     provides more improvements in glucose control for pre-diabetic patients than vigorous     intensity. The investigators hypothesize that moderate intensity exercise might be beneficial     for elderly individuals who are overweight or obese, specifically by: 1. Reducing damaging     excess protein acetylation (measured in muscle biopsy), 2. Improving the     acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function     as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing     insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators intend     to use the results of this study to show feasibility in measuring mitochondrial function at     Duke for a larger federal grant submission. Investigators hypothesize that carnitine     insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments     in glucose tolerance and insulin action.   "
88737|NCT02124577|"     This is a small preliminary study conducted to explore new methods for the potential of     aiding in diagnosis of liver fibrotic disease as well as predicting disease progression.     There will be a total of 4 visits spread out over approximately 8 weeks. You will be asked to     drink heavy water during most of that time. Heavy Water also known as deuterated water,     is physically and chemically very similar to ordinary drinking water. It tastes and feels     exactly like regular water. It is odorless and has no known harmful effects at the doses     given here. Heavy water occurs naturally, and is a minor component of the water we all ingest     daily.   "
88738|NCT02124564|"     This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200     mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have     partial-onset seizures with or without secondary generalization and who are treated with a     single Anti-Epileptic Drug (AED) with marketing approval in Japan.   "
88739|NCT02124551|"     The purpose of this study is to assess the suitability of the ear and forehead as a better     site for measure of fluid responsiveness.   "
88787|NCT02123914|"     1. Moderate exercise training decrease cytokine response and rhinitis symptoms in patients          with allergic rhinitis        2. Moderate exercise training combined with vitamin C supplementation decrease cytokine          response and rhinitis symptoms in patients with allergic rhinitis        3. Moderate exercise training combined with vitamin C supplementation has more beneficial          effects than moderate exercise training alone for decreasing cytokine response and          rhinitis symptoms in patients with allergic rhinitis   "
88740|NCT02124525|"     The purpose of this study is to investigate the efficacy of N-acetylcysteine (NAC) for     smoking cessation in a double blind, randomized, placebo-controlled trial. Simultaneously,     the study aims to elucidate the role of inflammatory markers and oxidative stress related to     nicotine addiction and the use of NAC, an acetylated precursor of cysteine, a naturally     occurring amino acid that has antioxidant actions in its own right, in reducing oxidative     stress and inflammation in smokers. It will evaluate the use of NAC in smoking cessation,     after 4, 8 and 12 weeks of treatment.   "
88753|NCT02124356|"     Emergency abdominal surgery is associated with high mortality rates, multiple postoperative     complications and prolonged duration of hospital admission. The purpose of this study is to     examine the postoperative functional performance in patients undergoing Emergency High-risk     Abdominal Surgery. The hypothesis is that the study can describe the patient population in     relation to postoperative functioning, degree of inactivity and the factors that limit     mobility.   "
88850|NCT02123069|"     The purpose of this study is to learn how uterine fibroids may be connected to heart disease     and high blood pressure. It is not known what causes fibroids, but they frequently occur in     women who also have high blood pressure, heart disease, and stroke. The investigators of this     study want to learn if certain changes in the blood vessels or nerve activity can put women     at risk for these diseases and for fibroids.   "
88851|NCT02123056|"     Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and     probably is responsible for CDN $250 million in health care spending each year. It is     associated with decreased quality of life, trauma, loss of employment, and limitations in     daily activities. The most common cause is vasovagal syncope.      This occurs in people of all ages, and is a lifelong predilection. While the median number of     faints in the population is 2, those who come to the investigators care have a median 10-15     lifetime spells, and have an increased frequency in the year before presentation. Vasovagal     syncope is due to abrupt hypotension and transient bradycardia, which cause cerebral     hypoperfusion. The pathophysiology may be either failure of venous return or progressive     vasodilation, both due to inappropriately low sympathetic outflow. Sympathetic stimulation     might be involved early in the reflex cascade. There is no known medical treatment for     frequent fainting. The investigators performed the pivotal CIHR-funded randomized trials that     showed that neither permanent pacing, beta blockers, nor fludrocortisone help the majority of     patients.      However 3 observational studies suggested that beta blockers prevent syncope in older     subjects, and the Prevention of Syncope Trial (POST1) showed in a prespecified, -stratified     analysis that patients ≥42 years tended to benefit. The investigators recent meta-analysis     showed a benefit from metoprolol in these patients, with a hazard ratio of 0.52 (CI 0.27 to     1.01), and an age-specific response to beta blockers (p = 0.007). These results suggest the     need for a randomized clinical trial of metoprolol for the prevention of vasovagal syncope in     older subjects. Accordingly,the investigators conducted a poll of 48 cardiologists and     neurologists in Canada and abroad: 98% stated that a randomized trial was necessary, and 92%     agreed to participate in such a trial. Separately, this study emerged as the first choice for     syncope randomized trials after consultation with Canadian and international experts.      Objective: To determine if treatment with metoprolol in patients ≥40 years old with moderate     to severely frequent vasovagal syncope will better suppress syncope recurrences than placebo.      Methods: This will be a longitudinal, prospective, parallel design, placebo-controlled,     randomized clinical trial.      Patients will be enrolled during a recruitment period of 4 years and followed for a fixed     period of 1 year. Subjects will have had ≥1 faint in the previous year, and a diagnosis of     vasovagal syncope based on a quantitative diagnostic score. They will be randomized to     receive either metoprolol or placebo at an initial dose of 50 mg bid. Dose adjustments will     be made according to treating physician discretion to optimize tolerance and compliance while     maximizing dose. The primary outcome measure will be the time to the first recurrence of     syncope (after a 2 week dose titration wash-in period) over the 1-year observation period.     The primary analysis will be performed on an intention-to-treat basis. Secondary analyses     will include an on-treatment analysis, as well as analyses comparing syncope and presyncope     frequency, number needed to treat, quality of life, impact of syncope on daily living, and     cost from the perspective of the publicly funded health care system. The investigators will     enroll 248 patients to have an 85% power to detect a reduction (p<0.05) in the primary     outcome from 50% (placebo group) to 30% (midodrine group), a 40% relative risk reduction.     This sample size also allows for a 11% rate of subject dropout with loss to follow-up before     a syncopal event. The University of Calgary Syncope Clinic has a well-functioning clinical     trial apparatus that successfully completed the randomized, multicenter Prevention of Syncope     Trials (POST1: metoprolol for vasovagal syncope; POST2: fludrocortisone for vasovagal     syncope) and SIRCAT (Statin-Induced Reduction of Cardiomyopathy Trial). Enrolment is underway     in the CIHR-funded POST3 (pacing versus loop recorders in syncope patients with bifascicular     block) and POST4 (midodrine for vasovagal syncope). Study centres that were highly productive     in POST1-4 have agreed to participate. The investigators therefore will have ample syncope     enrolling centres.      Relevance: This study will provide evidence to inform the use of metoprolol in the treatment     of moderate to severely frequent syncope in older patients with vasovagal syncope. Given the     lack of any other conventional medical therapy the investigators expect it to have rapid     impact on care.   "
88741|NCT02124512|"     Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency     towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline).     Individuals with metabolic syndrome often have impaired glucose tolerance, which is a     condition where blood sugar is normal when fasting (before eating), but is too high after     drinking a sugary drink. This is due to an abnormality in the body's sensitivity to insulin     (insulin resistance), which is due in part to an inability of the muscle to take up glucose.      People with metabolic syndrome have inflammation in their fat tissue and in their blood     stream, and the changes in the level of inflammatory chemicals produced by cells in your fat     tissues will be studied. One possible source of the inflammation may be the bacteria in the     intestine. When individuals eat fatty foods, some of the bacterial products become attached     to the fat in their blood and then get directed to fat tissue. The investigators wish to     determine whether individuals have an excessive amount of inflammation in their fat tissues,     and whether this inflammation comes from the bacteria in their intestines. To determine this,     the investigators wish to treat individuals with an antibiotic that reduces the bacteria in     their intestines and in their blood, and determine whether this reduces their overall level     of inflammation.   "
88742|NCT02124499|"     Prospective association study to analyse perioperative patients' outcome. Outcome comprises     intraoperative and postoperative complications e.g. cardio-vascular events, allergic     reactions, postoperative side-effects like nausea and vomiting, impaired wound healing,     increased or decreased drug effects, severe pain, long-lasting pain as well as long-term     outcome.      Possible variables which might have on influence: patient- and surgery-related data,     patients' genetic background etc.   "
88743|NCT02124486|"     Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause or causes.     The condition is associated with raised pressure in the brain and can cause disabling daily     headaches and loss of sight, which can be permanent. The raised brain pressure squashes the     nerves supplying the eye (also known as papilloedema) and this can affect vision. Over 90% of     patients with IIH are overweight and weight loss is the most effective treatment. Other     treatments for IIH have very little current evidence to support their use.      Weight loss is difficult to maintain. This trial aims to compare two methods of weight loss,     bariatric surgery and the most effective dietary programme commonly available, Weight     Watchers, to see which offers the most effective sustainable treatment for IIH. Bariatric     surgery is recommended by the NICE clinical guidelines for patients with a Body Mass Index     (BMI) of over 40, or over 35 with a co-morbidity. Women suffering from IIH have a BMI on     average around 38 and IIH is not recognised as a co-morbidity for bariatric surgery.      This trial will recruit 64 women with IIH from Neurology and Ophthalmology clinics in UK NHS     Trusts. They will be randomised and 32 participants will be allocated to the dietetic     intervention arm, and be enrolled in their local Weight Watchers group. 32 participants will     be allocated to the bariatric surgery arm, and will be referred to their local bariatric     surgery pathway to receive bariatric surgery. Both groups of participants will be allocated     to a treatment arm which is proven to bring about weight loss.      Participants will then be followed up for five years, with the most important measurement     being their brain pressure after one year of being in the trial.      A further 20 obese women who don't suffer from IIH will be recruited to compare the baseline     symptoms and biomarkers of those with IIH; they will take no further part in the study. 5     further healthy individuals will be scanned twice in an MRI test group to validate the MRI     scan sequence to be used in the trial.   "
88744|NCT02124473|"     Resistant hypertension (RHTN) is a common clinical problem faced by both primary care     clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular     events and mortality compared with patients with more easily controlled hypertension. In     addition, RHTN is often complicated by metabolic abnormalities.      Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the     impact on resistant hypertension. The aim of this trial was to evaluate individualized     homeopathy on BP in patients with resistant hypertension.   "
88745|NCT02124460|"     Health care system (HCS)-based interventions have been limited by their inattention to social     and environmental barriers that impede improvement in obesity-related behaviors.     Additionally, current pediatric obesity care delivery relies on an outdated provider:patient     paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the     organizational structure to provide longitudinal care for children with chronic illnesses,     the clinicians to manage and support patients with chronic illnesses outside of clinic,     and/or the health information systems that support the use of evidence-based practices at the     point-of-care. Thus, the research question this study is designed to address is whether a     novel approach to care delivery that leverages delivery system and community resources and     addresses socio-contextual factors will improve family-centered childhood obesity outcomes.      The primary specific aims are to examine the extent to which the intervention, compared to     the control condition, results in:        1. A smaller age-associated increase in BMI over a 12-month period.        2. Improved parental and child ratings of pediatric health-related quality of life.      The secondary aims are:        1. To examine parental ratings of quality and family-centeredness of pediatric obesity care          and compare outcomes among participants in the intervention with the control condition        2. To assess change in weight-related behaviors and compare outcomes among participants in          the intervention with the control condition        3. To assess the following process measures:             -  Reach             -  Extent of implementation             -  Fidelity to protocol             -  Parent satisfaction        4. To examine the extent to which neighborhood environments modify observed intervention          effects        5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS)          measures in participant medical records   "
88746|NCT02124447|"     This will be a 4-way comparison to prospectively evaluate the efficacy and patient     tolerability of four commercially available bowel preparations among patients undergoing     colonoscopy for screening and surveillance in a single tertiary academic medical center.   "
88788|NCT02123901|"     Walking Meditation training would yield more favorable adaptations than walking alone in     improving glycemic control and vascular function in patients with type 2 diabetes.   "
88747|NCT02124434|"     Surgery is considered the best therapy for morbid obesity and its comorbidities, where     alterations in lifestyle, diets and drugs have failed to achieve weight loss. The most widely     performed in Israel is Laparoscopic Sleeve Gastrectomy (LSG), and several studies have     reported high success rates in reducing weight and improving comorbidities common among obese     patients such as hypertension; diabetes mellitus type II; dyslipidemia; osteoarthritis;     obstructive sleep apnea etc.      The hypothesis of this prospective study is that the LSG is an effective treatment for     achieving weight loss, for improving and even curing comorbidities and for improving the     patient's QOL. Another supposition is that patient's socio-economic status can influence     success rates of bariatric procedures.   "
88748|NCT02124421|"     Community hospital based phase II (prospective randomized) study to evaluate the toxicity of     cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly     diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian     tube, and primary peritoneal cancer.   "
88749|NCT02124408|"     With the development of economy and change of lifestyles, it is characterized that there is a     dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes     patients are required to improve blood glucose and subsequent outcomes. Mobile phone     intervention was a kind of high cost efficiency and high quality health care. Our study     evaluated a diabetes coaching system, using mobile phones and patient/provider portals for     patient-specific treatment and communication.   "
88750|NCT02124395|"     Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney     Stone Consortium   "
88754|NCT02124343|"     Exercise is a cornerstone of pulmonary rehabilitation in the treatment of Chronic Obstructive     Pulmonary Disease (COPD). Although researchers have shown numerous benefits with exercise in     COPD patients, most studies have only looked at exercise tolerance and psychological outcomes     following training. COPD is characterised by persistent inflammation that can cause     progressive decline in lung function and multisystemic complications. This inflammation can     be amplified in patients when they suffer acute exacerbations. There is a wellknown     relationship between exercise, immune function and risk of infection. Exercise has also been     shown to have an antiinflammatory effect when performed regularly. There is a lack of     research looking into the inflammatory or immune response to exercise in patients with COPD.     The exercise within this study will be individually tailored to patients with COPD based on     their validated 6 minute walk test (6MWT) but the protocol will involve interval exercise     that has been used previously. This type of exercise is considered most appropriate for     research into mechanisms of benefit because it maintains the exercise training effects of     other modalities (e.g. continuous low intensity aerobic exercise) while avoiding the     occurrence of limitations to exercise in people with lung problems (e.g. dynamic     hyperinflation). It also closely mirrors daily activity of someone with COPD.      The investigators want to explore the effects of exercise specifically on immune function in     15 people COPD and compare any changes to 15 Controls. By better understanding the mechanisms     of how exercise affects inflammation, the investigators could eventually design better     Pulmonary Rehabilitation interventions, especially for those most at risk.   "
88755|NCT02124330|"     Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical     properties, such as swelling and cation exchange capability.      The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to     reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability     of immobilizing proteins.   "
88756|NCT02124317|"     The purpose of this study is to determine the efficacy and safety of nanoparticle     albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese     patients with advanced pancreatic ductal adenocarcinoma (PDA).   "
88757|NCT02124304|"     Cervical pain is a condition that affects 14.6% of all adults annually. Of this annual     prevalence, 37.3% experience persistent neck pain with periodic recurring episodes. The     purpose of this study is to compare muscle activation patterns of the cervical musculature     during exercises with elastic versus manual resistance in a neck pain and asymptomatic     populations. Methods: A convenience sample of 15 healthy, physically active participants and     15 current patients diagnosed with non-radicular cervical pain will be recruited.     Exclusionary criteria will include: current cervical or upper extremity injury (healthy     group), history of neck surgery, corticosteroid treatment within the last two weeks, and     radicular signs or symptoms. Surface electromyography will be used to quantify the activity     level of the bilateral SCM, AS, Cervical Paraspinal (CP), and the Upper Trapezius (UT)     muscles while performing a series of 6 exercises with elastic resistance using Thera-Band®     Resistance Bands and manual resistance. The area will be prepped and surface electrodes     placed on the corresponding muscles. The movement will be standardized by using the peak     activation (PA) of each muscle during full flexion-extension movement to create a percentage     of peak activation (%PA). The testing battery will consist of 6 exercises with elastic     resistance and manual resistance, totaling 12 different trials. Each trial will involve 5     repetitions, each held for 5 seconds. The exercises will include cervical: extension,     flexion, left rotation, right rotation, left side bending, and right side bending. The men     will use the green and women will use the red Thera-Band® Resistance Band. The order of     exercises will be randomized in to two parts to minimize the effect of fatigue. First,     cervical flexion and extension with manual and elastic resistance will be randomized.     Secondly, the remaining 8 exercises will be randomized. Following each exercise, the patient     will rate their perceived level of exertion on the Thera-band® Resistance Intensity Scale for     Exercise (RISE).   "
88758|NCT02124291|"     The objective of study is to assess the possible impact of assisted hatching on the     implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human     embryos.   "
88759|NCT02124278|"     The purpose is to determine if single doses of PUL-042 inhalation solution are safe in     healthy subjects.   "
88767|NCT02124174|"     Phase II trial combining azacitidine with valproic acid as maintenance therapy post     allogeneic stem cell transplantation in patients with high-risk MDS/AML. We hypothesize that     adding valproic acid to azacitidine will improve outcomes via both direct anti-tumor and     immunologically mediated antitumor response with alloreactive donor lymphocytes, having an     additive effect and extending 1 year survival in patient with high-risk AML/MDS after     hematopoietic stem cell transplant. Based on aforementioned data from the US Department of     Health and Human Services, standard 1 year survival for AML after stem cell transplant is     near 40%. We hypothesize that valproic acid and azacitidine will prolong survival, with a 1     year survival goal of 60%. In addition to assessing for 1 year survival, we will have     secondary objectives of assessing progression-free survival, relapse, and toxicity. The     primary toxicity endpoint from this will be cytopenias and infections.   "
88768|NCT02124161|"     The purpose of this study is to evaluate the immunogenicity and safety of 13-valent     pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated     influenza vaccine to adults 50 years and older who have previously received 23-valent     pneumococcal polysaccharide vaccine.   "
88760|NCT02124265|"     In patients with moderate to severe thermal injuries (> 20% TBSA) adequate fluid     resuscitation is the main priority to achieve successful outcomes. Soon after burn injury     substantial amounts of fluid accumulate rapidly in the wound while more is lost in the third     space. Without intervention this process leads to hypotension and shock. The Parkland formula     was devised to calculate how much intravenous (IV) fluid, i.e. crystalloids, is needed for     adequate resuscitation during the first 24 hours post-burn. However, IV resuscitation can     lead to overexpansion of (third space) volume, leading to severe complications such as     compartment syndrome or pulmonary edema.      In major population centers, catastrophic events causing mass casualties will disrupt many     hospital and emergency services, potentially delaying acute IV fluid resuscitation. Burn     patient case reports have shown that oral rehydration therapy (ORT) used to supplement or in     place of IV therapy is efficacious. ORT could be easily applied in mass burn casualties.      ORT is generally known in the third world for treating life-threatening dehydration due to     diarrhea. The glucose-sodium co transport mechanism enables the affected human intestine to     absorb a sufficient amount of water and electrolytes to replace large fluid losses due to     severe diarrhea, even under adverse field conditions. No electrolyte disturbances have been     recorded in such cases. Studies on enteral resuscitation in animal burn models showed high     rates of small intestinal absorption which should be adequate for resuscitation following     major burn injury.      The optimal composition of oral rehydration solution for resuscitation in burn wounds has not     been determined. In cholera patients, Ceralyte® has proven superior to the WHO Oral     Rehydration Solution, increasing fluid absorption of the intestine. The Ceralyte® 90     solution, with 90mEq/L sodium and a low osmolarity of <275mOsm, may also contribute to     optimal intestinal fluid uptake without causing electrolyte disturbances in thermal injury.     ORT use might reduce the occurrence of compartment syndrome and pulmonary edema since fluid     is regulated by the intestine according to physiologic requirements. The investigators     propose to conduct a prospective study using Ceralyte® 90 to show that oral resuscitation     therapy (ORT) in burns can reduce the total amount of IV fluid needed for adequate     resuscitation and to test the efficacy and safety of ORT in the resuscitation of burn     patients.   "
88761|NCT02124252|"     There are many challenges to implementation of cervical cancer prevention in resource-limited     countries, despite evidence based screening and treatment strategies. The investigators     hypothesize that self-collected HPV specimens offered in a community health campaign setting     will   "
88762|NCT02124239|"     This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel     groups will be enrolled. The trial includes three active treatment groups.      To be eligible for inclusion in this trial, subjects must have at least 10 clinically     typical, visible, and discrete AKs on the face, balding scalp or on the arm within a     contiguous area of approximately 250 cm2 of sun-damaged skin.      There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027%     on the full face for three consecutive days, (2) the same regimen on the balding scalp, and     (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of     approximately 250 cm2 for four consecutive days.   "
88797|NCT02123784|"     Identification of biomarkers that can predict the outcome of the surgical treatment (i.e. the     rate of re-rupture) of tears in the rotator cuff tendon.   "
88798|NCT02123771|"     The investigators hypothesis:      Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.   "
88763|NCT02124226|"     Patients with chronic severe asthma (CSA) have a crippling disease and current available     treatments are not satisfactory. Thus, management of CSA remains a major unmet need. Although     the evidence from existing randomized controlled trials fails to support a definite role for     immunomodulatory drugs in these patients due to major methodologic drawbacks, findings with     low-dose methotrexate (MTX) are encouraging. However, larger and well designed clinical     trials are required to establish the beneficial role of MTX in CSA and for the detection of     the key characteristics of those who are going to respond to this drug.      This study will be the first multi-centre RCT investigating the role of an add-on     immunological modifier as a clinically useful therapeutic strategy in patients with     well-phenotyped chronic severe asthma. As such, this study does not overlap with any other     research currently ongoing.   "
88764|NCT02124213|"     This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In     healthy male volunteers   "
88765|NCT02124200|"     E-cigarettes are proving to be an attractive long-term alternative to conventional     cigarettes. Although they may also help smokers to remain abstinent during their quit     attempt, recent clinical trials with first generation e-cigarettes have shown only modest     quit rates. Second generation devices may result in much higher quit rates. Their efficacy     and safety in long-term smoking cessation and/or smoking reduction studies have never been     investigated.      In this prospective proof-of-concept study we monitored modifications in smoking habits of 50     regular smokers (unwilling to quit) who were asked to switch to a second generation device     focusing on smoking reduction and smoking abstinence. Study participants were invited to     attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24.     Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were     measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse     events and participants' opinions of these products were also reviewed.   "
88766|NCT02124187|"     It is well established in studies across several countries that tobacco smoking is more     prevalent among depressed patients than the general population. Electronic cigarettes are     becoming increasingly popular with smokers worldwide. To date there are no large randomized     trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to     compare efficacy and safety of these products in this special population.      We have designed a randomized controlled trial investigating the efficacy and safety of     electronic cigarette. The trial will take the form of a prospective 12-month randomized     clinical study to evaluate smoking reduction, smoking abstinence and adverse events in     depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive     functioning and measure participants' perception and satisfaction of the product.      Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be     calculated at each study visit (reducers). Abstinence from smoking will be calculated at     each study visit (quitters). Smokers who leave the study protocol before its completion and     will carry out the Early Termination Visit or who will not satisfy the criteria of reducers     and quitters will be defined non responders.   "
88769|NCT02124148|"     The main purpose of this study is to investigate the safety of prexasertib in combination     with other anti-cancer drugs (cisplatin, cetuximab, pemetrexed, fluorouracil or LY3023414) in     participants with advanced cancer or cancer that has spread to another part of the body. The     study has multiple parts (A, B, C, D and E). Participants will only enroll in one part.   "
89560|NCT02113826|"     Alveolar soft part sarcoma (ASPS), a rare subset of STS (<1%) harbors t(X;17)(p11;q25)     translocation and produces resultant ASPL-TFE3 fusion protein. Due to its nature of high     expression of angiogenic factors, sunitinib and cediranib produced overall response rates of     55% and 43%, respectively. However, the efficacy of pazopanib is unknown in metastatic ASPS.   "
88770|NCT02124135|"     Dietary counseling at the point of purchase could improve patient adherence to dietary advice     and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel     delivery system for dietary advice. We will study the effect of relocating family weight     management counseling sessions into restaurants, where registered dieticians and patients     will conduct scheduled group visits while enjoying a meal together. As with office-based     visits, our goal is for members and their families to learn how to select food options based     on their unique health needs, budgetary concerns, and time constraints. In contrast to a     traditional counseling visit, however, co-dining with a dietitian will give members a     hands-on experience designed to enhance their learning and improve adherence. The proposed     study would build on an existing pilot of a similar program, the KP Personal Shopper, where     dietitian visits were conducted with individuals either in the clinic setting or while     shopping in a grocery store.      We will compare the new Eat Out with Kaiser approach to the current standard of     clinic-based dietary and lifestyle counseling for weight management among 40 families     affected by obesity, with the following outcomes in mind:        1. Change in dietary measures        2. Nutritional knowledge of families        3. Participant self-efficacy and confidence in food purchasing decisions        4. Participant and dietician perception of visit      We hypothesize that, compared to clinic-based visits, our Eat Out with Kaiser visits will     result in more favorable perception of the visit by both dietitian and participant, higher     nutritional knowledge scores, higher self-efficacy and confidence of patients around food     decisions, and larger improvements in diet components.   "
88771|NCT02124122|"     This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr)     strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a     clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric     diarrhea in Peru.   "
88772|NCT02124109|"     Background:      - An acquired heart disease is one that a person gets after they are born. Two of these are     rheumatic heart disease (RHD) and endomyocardial fibrosis (EMF). They are found more commonly     in people who live in Africa than in other places in the world. Researchers want to learn     more about these diseases. They especially want to know what role genes and other factors     play in them.      Objective:      - To identify genetic risk factors for RHD and EMF in sub-Saharan Africa.      Eligibility:        -  Children and adults with RHD or EMF.        -  Healthy volunteers over age 10.      Design:        -  Participants will come from existing study groups in Uganda and Nigeria.        -  Participants may be required to provide a sample of their DNA. They will do this with          either a blood or saliva sample or a swab of the mouth.        -  Collected samples will be labeled with a code and sent to a lab in the United States for          analysis. Remaining portions of participants samples will be stored for an unlimited          period of time. They may be used in future studies.        -  Some genetic and health information from participants might be placed into one or more          scientific databases.        -  Participant names and identifying information will be kept private. But there is a small          chance someone could trace them from their genetic information.   "
88773|NCT02124096|"     Background:      - The flu is a very infectious and contagious virus that affects both people and pigs.     Studies show that pigs can be sources of the flu virus in humans. Researchers want to know     more about how the flu is transmitted from animals to people. If they know more about it,     they can find better ways to prevent the flu and treat people who get sick from it.      Objective:      - To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural     fairs.      Eligibility:      - Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs.      Design:        -  Before or on the first day of the fair, participants will fill out a short demographic          and medical history form. They will also complete a two-page symptom questionnaire. This          is a form that asks them about any flu symptoms they might have.        -  Participants will have a nasal swab performed. The inside of the participant s nose will          be rubbed with a swab to collect nasal fluid.        -  Researchers will see participants 2 days later and 4 days later. During these visits,          participants will again fill out a symptom questionnaire and have a nasal swab.   "
88774|NCT02124083|"     Niemann-Pick disease type C (NPC) is a lethal, autosomal recessive, lysosomal storage     disorder characterized by neurodegeneration in early childhood and death in adolescence. The     causative genes NPC1 (about 95% of cases) and NPC2 (about 5% of cases) are involved in the     intracellular trafficking of lipids and cholesterol. Mutations on either of these genes lead     to progressive accumulation of unesterified cholesterol and other lipids in the central     nervous system (CNS). Vorinostat is a histone deacetylase inhibitor that has been shown in     vivo to increase mutant NPC1 protein levels and to reverse cellular accumulation of     unesterified cholesterol. Vorinostat has been labeled by the FDA for treatment of cutaneous     T-cell lymphoma. In this Phase I, non-randomized, open-label, single-center study, we plan to     study whether Vorinostat can be repurposed to treat patients with NPC1. Our primary objective     is to determine the safety and tolerability of Vorinostat in NPC1 disease. Our secondary     objectives will be to determine biochemical efficacy of Vorinostat to increase expression of     NPC1 protein and normalize lipid and protein biomarkers. This study will enroll up to 12 NPC1     patients and test the safety of two dose levels (200 and 400 mg). Drug will be administered     on a 3 days on/4 days off schedule for 3 months at each dose level. Patients will be     evaluated at the NIH Clinical Center at 0, 3 and 6 months. Safety will be assessed by adverse     events (AEs), clinical laboratory tests and physical examinations. Biochemical efficacy will     be assessed by measurement of serum and cerebral spinal fluid biomarkers. Clinical efficacy     will be evaluated by audiologic testing, assessment ataxia, and swallowing studies.   "
88782|NCT02123979|"     Narcotics are widely used as the mainstay of pain treatment, although increasing doses are     required over time as the individual becomes tolerant to their effects. This can lead to the     development of dependence and abuse of these drugs. Research has identified a new way to     decrease the risk of developing tolerance to narcotics, by giving at the same time a drug     called rotigotine (Neupro). Rotigotine interferes with the body's chemical dopamine and is     FDA-approved for the management of Parkinson's Disease.      The purpose of this research study is to look at side effects and pain control in healthy     people after removal of wisdom teeth, which usually causes pain. It is thought that by giving     the study drug rotigotine with the narcotic pain reliever, there will be pain control that     will extend longer than when giving the narcotic alone.   "
88775|NCT02124070|"     Background:      -(Degree)ystinosis is an inherited disease. If not treated correctly, it can cause muscle     wasting and weakness and kidney damage. Researchers want to learn if growth hormone (GH) can     help people with cystinosis.      Objective:      - To learn if GH treatment can slow or reverse muscle wasting and improve muscle strength in     people with cystinosis.      Eligibility:      - People 18 and older who are already enrolled in protocol 78-HG-0093.      Design:        -  Participants will be admitted to the clinic for eight 3 4 day visits, mostly four months          apart.        -  At each visit, participants will have a history and physical exam and give urine and          blood samples.        -  At month 0 or 13, participants will take tests that will be repeated at their 12- or          25-month visit:        -  They will have an eye exam, medical consultations, and strength and movement tests.        -  They will complete questionnaires.        -  They may have tests of heart activity and lung function.        -  They will have ultrasound imaging of their arm and hand muscles. They will have a scan          of their legs while lying in a magnetic resonance imaging machine (a big metal          cylinder). They will have a DEXA bone scan (two X-ray beams measure body composition).          They will also swallow barium while X-ray imaging records the throat muscles.        -  Participants will be randomly assigned to either receive or not receive GH for the first          12 months. Then, at month 13, if they received GH, they will switch for the next 12          months.        -  Participants will take GH as a daily injection. They will be taught how to give the          injections.   "
88799|NCT02123758|"     The purpose of this study is to investigate potential drug-drug interaction (DDI) between     JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine     safety of the combination and evaluate in a descriptive manner the efficacy in these     participants. It will also, potentially provide dosing recommendations for abiraterone     acetate in future studies when combined with JNJ-56021927.   "
88800|NCT02123745|"     A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the     ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV     therapy.   "
88801|NCT02123732|"     This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of     therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in     patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but     less than 8.0% on their current conventional therapy.   "
88862|NCT02122913|"     This is a multicenter, open-label, Phase 1 study of orally administered larotrectinib in     adult subjects with advanced solid tumors that have progressed or are non responsive to     available therapies and for which no standard or available curative therapy exists.   "
88776|NCT02124057|"     Background:      - Spinal and bulbar muscular atrophy (SBMA) is an inherited disease. It causes weakness in     muscles used for swallowing, breathing, and speaking. SBMA mainly affects men, but women can     carry the gene for it. Researchers think there may be a link between SBMA and excess fat in     the liver.      Objective:      - To look for fatty liver and liver injury in people with SBMA, people with motor neuron     disease, and people who carry the gene for SBMA.      Eligibility:        -  Adults 18 years and older who have SBMA, have motor neuron disease, or are carriers of          SBMA.        -  Healthy adult volunteers.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Participants will have 1 outpatient visit of 1-2 days. Women will have a urine pregnancy          test. All participants will have:        -  Blood tests.        -  Liver ultrasound. A probe is placed on the abdomen at certain locations and angles and          takes pictures. The painless procedure takes 20-30 minutes.        -  Liver magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder with a          magnetic field. Participants will lie on a table that slides in and out of it. They will          be in the scanner for about 30 minutes. They will get earplugs for loud noises.        -  Some participants with abnormal liver testing will have a biopsy (small piece) of the          liver taken. The biopsy site will be located with ultrasound, then cleaned and numbed.          The physician will quickly pass a needle in and out of the liver while the participants          holds their breath. Afterward, participants will be monitored in bed for 6 hours.        -  Participants may return for follow-up and another 1-2 day outpatient visit yearly for up          to 2 years.   "
88777|NCT02124044|"     Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated     180 million people infected worldwide. In the United States an estimated 4.1 million people     are infected and HCV is the principal cause of death from liver disease and leading     indication for liver transplantation. Within HIV/HCV co-infected patients, liver disease due     to Hepatitis C progresses even more rapidly. While combination of ribavirin (RBV) and     pegylated interferon (PEG) in combination with boceprevir/telaprevir is the currently     recommended therapy for chronic HCV infection and has superior cure rates compared to PEG+RBV     alone in HCV monoinfected patients, treatment is still associated with a high incidence of     adverse events (AEs), discontinuations and poor cure rates in several populations. Within the     HIV/HCV co-infected population treatment for HCV remains complicated given drug interactions     between anti-retrovirals and HCV protease inhibitors, in addition to the extensive     side-effects due to PEG +RBV alone. Recent studies have demonstrated that the use of a     combination of anti-virals which target HCV without interferon (IFN) can cure HCV, without     additional toxicities. These novel therapies that do not rely on an IFN backbone may     additionally enhance cure rates in HIV/HCV co-infected, a population which has historically     been difficult to cure.      The findings from this study will aid in the understanding of antiviral and host responses     and determinants of response to an IFN free regimen in HIV/HCV co-infected patients.   "
88778|NCT02124031|"     The purpose of this study is to evaluate quality of life, degree of disability, treatment     patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in     Mexico.   "
88779|NCT02124018|"     The purpose of the study is to assess the prevalence and the prognostic value of non-invasive     indexes and programmed ventricular stimulation for sudden cardiac death in post-MI patients     with LVEF >40%.   "
88780|NCT02124005|"     The purpose of the study is to determine the minimum effective concentration of bupivacaine     (EC50) in femoral block for analgesia by ultrasound after knee surgery.   "
88781|NCT02123992|"     The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical     and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in     a controlled, post-market cohort study.   "
88802|NCT02123719|"     Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.      Study group: Patients with incisional hernia post liver transplantation Control group:     Patients with incisional hernia post any other laparotomy in the upper quadrant.      Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome     parameters: - Hernia repair-related infection rate      - Postoperative morbidity Statistical analysis: Comparison of study versus control group,     univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were     considered significant.   "
88789|NCT02123888|"     The cone beam image is a part of the radiotherapy treatment machine and uses lower energy     xrays as the head of the radiotherapy machine moves around the patient in a circle. This     takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are     better at showing the position of the tumour and surrounding soft tissues than the standard     xrays that were previously used. Cone Beam Imaging Technology is not new and has been used     regularly at The Christie for many years. The standard cone beam scan is taken before the     actual radiotherapy treatment or after the treatment has been delivered.      Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering     radiotherapy that involves the continuous movement of the radiotherapy treatment machine head     around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented     at The Christie for prostate radiotherapy treatments and work is in progress for     implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery     makes this simultaneous imaging possible, although there are concerns associated with the     impact that this may have on patient dose and image quality.      The aim of this research is to assess whether the image quality of cone beam scans taken     during treatment are as good as standard cone beam scans taken before or after treatment used     to determine the accuracy of patient position and the tumour coverage by radiotherapy.   "
88790|NCT02123875|"     ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model     which proves to offer several advantages in low and mid income countries. The objectives of     the pilot stude were to determine that with a randomized blinded outcome assessor, controlled     trial, family- led caregiver- delivered home based rehabilitation is better than usual care     for those with disabling stroke in India and the feasibility of this model.   "
88791|NCT02123862|"     The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before     and after treatment using an experimental method for detecting CTC, compared to commercial     CTC assay results, in patients with prostate, breast or colorectal cancers.      Experiments will be done to develop a new assay technique and also test how CTC react to     commonly used drugs. This information will be analyzed to determine if the experimental     assays can be helpful in the future to predict how a patient's cancer may react to certain     treatments.      The research experiments will also attempt to grow CTC for long-term or immortal cell lines     that can be further studied for proteins and gene mutations related to the specific tumor     (not familial), and testing for sensitivity to drugs.      Blood samples will be collected at specific time points during routine medical care from     patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be     collected from patients with no cancer for comparison purposes. Samples for the experimental     tests will be identified only by codes and results will not be shared with participants.     Patients with prostate, breast or colorectal cancer will also have blood samples drawn for     commercial CTC assays as part of their standard care.   "
88792|NCT02123849|"     This randomized phase II trial studies the safety and effects of acetylsalicylic acid     (aspirin) taken continuously or intermittently on gene expression in the nasal tissue of     current smokers. Smokers are at increased risk of developing lung cancer. Acetylsalicylic     acid may be useful in preventing lung cancer.   "
88793|NCT02123836|"     A novel method has been developed to expand natural (NK) cells and enhance their cytotoxicity     against cancer cells while maintaining low killing capacity against non-transformed cells. In     this method, donor NK cells are expanded by co-culture with the irradiated K562 cell line     modified to express membrane bound IL-15 and 41BB ligand (K562-mb15-41BBL). Expression of     these proteins in conjunction with unknown stimuli provided by K562 cells promotes selective     growth of NK cells. Then, the expanded NK cell population is depleted of T cells to prevent     graft versus host disease (GVHD). Expanded and activated NK cells showed powerful     anti-leukemic activity against acute myeloid leukemia (AML) cells in vitro and in animal     models of leukemia.Unpublished laboratory results also demonstrated that T-cell acute     lymphoblastic leukaemia (T-ALL) is extremely sensitive to the cytotoxicity exerted by the     expanded and activated NK cells.      The present study represents the translation of the laboratory findings into clinical     application. The study proposes to determine the feasibility, safety and efficacy of infusing     expanded NK cells into patients who have AML or T-lineage ALL which is resistant to standard     therapy as demonstrated by persistent minimal residual disease (MRD). Patients with     myelodysplastic syndrome (MDS), who are at high risk to develop AML will also be eligible for     the study. In this patient cohort, the study will also investigate the in vivo lifespan and     phenotype of the expanded NK cells.      The main hypothesis to be tested in this study is that infusion of expanded activated NK     cells can produce measurable clinical responses in patients with AML or T-ALL.   "
88794|NCT02123823|"     Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose,     and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in     combination with exemestane in women with HR+/HER2- advanced breast cancer   "
88795|NCT02123810|"     The investigators sought to evaluate the influence of fatigue after a night shift on the     quality of Chest Compressions (CC) in CardioPulmonary Resuscitation (CPR), among physicians.   "
88825|NCT02123407|"     Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by     lymphatics after injection into the tissue and draining regional lymph nodes are thereby     colored black,which may provide surgeons the guidance to lymph node dissection and help them     harvest lymph nodes after surgery,especially some small ones. but there was insufficient     evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a     prospective randomized controlled trial on lymph node vital staining for lymph node     dissection and harvesting in advanced gastric cancer to test this idea.   "
88826|NCT02123394|"     The purpose of this study is to assess the efficacy of the McKenzie method in patients with     chronic non-specific low back.   "
88796|NCT02123797|"     Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The     overall year survival rate has only improved from 12% to 17% in 33 years. This failure     reflects the innate lethality of lung cancer, but also reflects defects in patient care     delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds     through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage),     selection of appropriate treatment, and finally ends with patient outcomes. At each step are     multiple options and independent specialists, each one engaged by a process of sequential     referrals in the serial care model. This process is often not user-friendly, is riddled with     inefficiency, delays, and outcome variances.      The coordinated multidisciplinary model, in which patients and their doctors collaborate to     provide evidence-based care, is believed by experts to be superior, but has few examples of     successful implementation. The implementation gap exists because of the paucity of good     quality data, and lack of implementation know-how.      Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a     racially, culturally, economically and geographically diverse population. The investigators     research group has shown how poor quality care impairs patient survival in this region and in     the greater US. The investigators have linked patient survival to compliance with     multidisciplinary care plans. In this project, the investigators propose to rigorously test     the impact of the multidisciplinary care model on patient outcomes in a community-based,     private practice environment, similar to where 70% of lung cancer care is delivered in the     US.      The objective of this study is to provide high-level evidence of the impact of     multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as     a model of care in which patients, their care-givers and key specialists concurrently and     directly evaluate the same patients in the presence of the patients and their informal     caregivers, in order to develop evidence-based consensus care plans   "
88804|NCT02123680|"     Non-specific chronic low back pain guidelines recommend rehabilitation along with a     biopsychosocial approach. However, though psychological and social issues address important     needs of professionals and patients, they have been scarcely developed in this area so far.     Noteworthy, little is known about patients' expectations relative to physiotherapy for     chronic low back pain (CLBP), while professional recommendations advocate taking them into     consideration.      A study about patients' experience will provide knowledge about the ill person's perspective     and how the physiotherapists are perceived as well as the role attributed to them. The aim of     this study is, thus, to explore the experience of the patients suffering from CLBP in order     to highlight their expectations toward physiotherapy services and physiotherapists.      The investigators will apply a critically interpretive socio-anthropological approach based     on patients' interviews and observations in an intensive CLBP rehabilitation program. The     results will help improve the care patients receive by facilitating the integration of     biopsychosocial issues related to patient's expectations into the treatment.   "
88805|NCT02123667|"     Multinational, multicentre, non-pharmacological intervention, cross-sectional and     longitudinal study.   "
88806|NCT02123654|"     The purpose of this study is to demonstrate that the proportion of treatment-naive     non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir     (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C     virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week     12, is significantly higher than SVR12 of current Standard of Care (SOC).   "
88807|NCT02123641|"     A minimum of 450 healthy individuals (62-70 years old) will be recruited.      Each individual will be randomized into one of three groups stratified according to gender     (M/F), BMI (≤28/>28), and 30 sec chair stand (≤11/>11). The three groups are Heavy resistance     training (n=150), moderate intensity training (n=150), and control (n=150, no training).      Assessments will be performed at baseline, after 12 months of intervention. Furthermore,     follow up will be performed after 2,4,7, and 10 years.      The primary outcome is change in leg extensor power after the intervention and during follow     up.      The primary hypothesis is that by applying the intention-to-treat analysis, the moderate     intensity training group will increase leg extensor power just as much as the heavy     resistance training group. The two training groups will increase muscle power more than the     control group.   "
88808|NCT02123628|"     The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week     antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.   "
88809|NCT02123615|"     ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of     injectable products to it's optimum/right spot, just outside of the fascia, which exists     subdermally (between the skin and muscle). Bloodless basically implies longer lasting     medicinal effects, and minimal side effects - advantages that reflect the NIH mission of     enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS     device is stabilized on the surface of the skin with negative pressure and emits an     electrical current to create a bloodless cavity subdermally. ASIS device correctly,     automatically, and consistently delivers therapeutic agents, yet requiring little skill of a     practitioner - providing the steady and safe infusion into subdermal bloodless space of     virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel,     Insulin, and Fillers, etc. According to the FDA, This innovation will have major impact on     the healthcare industry.   "
88810|NCT02123602|"     The investigators hypothesize that the use of trunk (core) stabilization exercises early in     treatment combined with lower extremity exercises will enhance the outcome over lower     extremity exercises alone in the treatment of young athletes with anterior knee pain.   "
88811|NCT02123589|"     The study was designed to explore the effects of different sedation protocol on incidence     rates of delirium and PTSD in severe patients with mechanically ventilation.   "
88812|NCT02123576|"     Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and     octreotide therapy is superior to the standard of care alone in the treatment of Type I     hepatorenal syndrome in the first 14 days of hospitalization.   "
88827|NCT02123381|"     This study aim to investigate Changes in tumor tissue and serum biomarkers before and after     cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower     segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers     to predict and evaluate the patients who will be benefit from cetuximab combined with     preoperative radiotherapy.   "
88947|NCT02121808|"     The risk of complications associated with airway management in obese patients is significant.     The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician.     The increase in FRC and non-hypoxic apnea time is correlated. The best condition to     accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical     literature.      This study is designed to evaluate the effect of different positions combined with different     ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will     evaluate the effect of different combinations of positions and ventilation modes on pulmonary     volumes (mainly functional residual capacity) in a morbidly obese volunteer.   "
88813|NCT02123563|"     Diabetes and obesity affect many people in different countries. Similarly, millions of people     have some type of gum disease such as gingivitis. The present study was conducted to clarify     if systemic conditions such as diabetes and obesity could impair the response to gingivitis     treatment. Subjects with gum disease showing diabetes type II (from 40 to 50 subjects),     slight to moderate obesity (from 40 to 50 subjects) or its combination (from 40 to 50     subjects) were selected for the present study. In addition normal-weight subjects with gum     disease (from 40 to 50 subjects) besides a group without gum disease (from 40 to 50 subjects)     were selected for comparisons. After verbal and written explanations about the study,     subjects who matched study criteria and who signed the informed consent form underwent full     oral examinations in two separate visits. In the first visit, after a clinical examination to     verify the levels of gingival inflammation and the accumulated amounts of dental plaque, the     bone height was determined by X-Ray examinations. Bad breath was also evaluated by a     chair-side apparatus. Additional laboratorial examinations included a) quantification of     bacteria that cause gum disease from dental plaque samples, b) quantification of inflammatory     products from gingival fluid sampling and c) quantification of produced saliva. Self-report     questionnaires were used to check the impact of oral condition and treatment of gum disease     in quality of life and individual daily performance. These examinations were repeated 3     months after dental treatment. All subjects received ultrasonic dental prophylaxis for     cleaning their teeth. Based on systemic/oral conditions each group rinsed either an     essential-oils containing mouth rinse or a placebo rinse. First rinse was supervised and the     other ones were performed at home twice a day for three months. Each participant also     received a toothbrush, a dental floss and a fluoride toothpaste monthly after oral hygiene     instructions. Adherence to the treatment and occurrence of undesirable side effects were     monitored throughout the study.   "
88814|NCT02123550|"     This prospective controlled study examines the use of Doppler ultrasound as a means to screen     elective plastic surgery patients for the presence of deep venous blood clots both before and     after surgery. This is a noninvasive technique that is known to be both sensitive and     specific for the detection of deep venous thromboses in the lower extremities. This method     may make it unnecessary to select patients for prophylactic anticoagulation, which poses     additional risks to the patient.   "
88815|NCT02123537|"     People with multiple sclerosis (MS) often suffer from foot drop, which impairs their walking     ability. Foot drop is the inability to lift the foot during the swing phase of walking. The     purpose of this study is to find out if electrical stimulation of the leg, using the Bioness     L300 Foot Drop System, can be used to treat foot drop in people with MS. It is expected that     using this system will reduce foot drop, and therefore improve walking ability, particularly     in the areas of speed, strength, balance and falls.   "
88817|NCT02123511|"     This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen     saliva thickness and painful mouth sores in patients with head and neck cancer undergoing     radiation therapy. Side effects from radiation therapy to the head and neck, such as     thickened saliva and mouth sores, may interfere with activities of daily living such as     eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine     rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients     with head and neck cancer undergoing radiation therapy.   "
88818|NCT02123498|"     The purpose of this study is to investigate the relationship between ear fullness, pressure,     and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve     therapeutic outcomes in this patient population.   "
88819|NCT02123485|"     The aim of the present study is to investigate in which degree low frequency right prefrontal     rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate     remission .      To investigate the correlation between blood concentration of specific inflammation makers     and change in depressive symptoms during treatment   "
88820|NCT02123472|"     The purpose of this study is to compare two different preparations of an antibiotic called     cephalexin to determine if they are essentially the same. The study has two periods.     Participants will receive one preparation of cephalexin in each period. At least 7 hours will     pass between the study periods. The study is expected to last about 2 days for each     participant, not including screening or follow-up.   "
88821|NCT02123459|"     The purpose of this study is to compare two different preparations of an antibiotic called     cephalexin to determine if they are essentially the same. The study has two periods.     Participants will receive one preparation of cephalexin in each period. At least 7 hours will     pass between the study periods. The study is expected to last about 2 days for each     participant, not including screening or follow-up.   "
88822|NCT02123446|"     The purpose of this study is to compare two different preparations of an antibiotic called     cephalexin in capsules to determine if they are essentially the same. The study has two     periods. Participants will receive one preparation of cephalexin in each period. At least 7     hours will pass between the study periods. The study is expected to last about 2 days for     each participant, not including screening or follow-up.   "
88823|NCT02123433|"     S. pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also     cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects     are more sensitive to invasive diseases and recurrent infection than the general population.     Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more     frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain     and their nasopharyngeal isolates have features similar to subsequent invasive strains. A     23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+     population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+     are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an     hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover, PPV23     seems not to affect pneumococcal carriage status and could lead to emergence of non-vaccine     serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier proteins     results in an improved T-cell dependent immune response, characterized by increased antibody     concentrations and induction of T and B memory cells, with a demonstrated higher efficacy in     children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is approved in     Europe since 2001 and is effective in reducing incidence of invasive disease by vaccine     serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect of herd     immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes plus 1, 3,     5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric patients, that     are the main target of conjugate vaccines licensure. Some trials showed a better antibody     response in terms of quantity and quality in HIV + adults by using PCV7 as compared to PPV23.     However these data were not unequivocally confirmed in further studies on the use of PCV7     alone or in combination with PPV23. The first trials of PCV13 use in adults showed the same     or even better response compared to PPV23, with a safety and tolerability similar to PCV7.     PCV13 in HIV+ adults is a promising candidate prophylactic measure for pneumococcal     infections. The purpose of this study is to evaluate serological response and prevalence of     nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults, following     vaccination with 2 doses of PCV13.   "
88824|NCT02123420|"     The present study tested the hypothesis that Platform Switching (PS) and Regular Platform     (RP) implants would have different outcomes in the bilateral single tooth replacements     against the alternative hypothesis of no difference.   "
89623|NCT02113007|"     This study will evaluate the safety and efficacy of high-dose rituximab combined with     temozolomide in the treatment of patients with Primary Central Nervous System Lymphomas     (PCNSL). This novel combination will be evaluated in PCNSL patients who are 60 years of age     or older, or in patients 18 years or older who refuse methotrexate-based treatment.   "
88828|NCT02123368|"     Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological)     of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients     with knee osteoarthritis.      Patients and methods      Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10     patients for each group. The investigators compare the intraarticular injection of hialuronic     acid against the administration of two different doses of mesenchymal stem cells with     hialuronic acid according to the following scheme:        1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.        2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous          mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small          volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an          intraarticular injection Hiaurónico Acid ( Hyalone®).        3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous          mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small          volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an          intraarticular injection Hiaurónico Acid (Hyalone®).      The primary endpoint is safety and feasibility. The investigators registered the occurrence     of complications and / or adverse effects during the study.      In addition the investigators assess the response to intra-articular infusion of CMM     analyzing the following parameters:        -  Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since          treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.        -  Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.        -  Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the          number location of the lesions , cartilage thickness , signal intensity , subchondral          bone alteration , volume and WORMS and dGEMRIC protocols.   "
89054|NCT02120417|"     This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the     overall survival of women with advanced or metastatic HER2-negative breast cancer who     received treatment with capecitabine in combination with ruxolitinib versus those who     received treatment with capecitabine alone.   "
88829|NCT02123355|"     The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life     quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and     POCD is also correlated with many other factors such as type of surgery, the duration of     anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in     geriatrics is important.      Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy     whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the     prolonged surgery.      The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive     function at prolonged surgery in geriatrics in geriatrics.   "
88830|NCT02123342|"     The purpose of the study is:      1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an     health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized     controlled trial (RCT).      Hypothesis: Frequency and duration of the exercise programme execution will be higher for the     SMS reminder condition compared to the programme only condition. The effect may be reduced     from post- to follow-up measurement (24 weeks after baseline and 12 weeks after     post-measurement) but all outcomes will remain significantly higher at 24 weeks.   "
88831|NCT02123329|"     Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth     Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar     smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths.     Health care providers are in an ideal position to encourage smoking cessation. Pharmacists     are the most accessible health care providers and are uniquely situated to initiate behavior     change among patients. Many western studies have shown that pharmacists can be successful in     helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist     delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the     effect of a structured smoking cessation program delivered by trained ambulatory pharmacists     in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory     pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session     face-to-face structured patient-specific smoking cessation program conducted by the     pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the     pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of     smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven     to be effective, this smoking cessation program will be considered as a model that Qatar and     the region can apply to decrease smoking burden.   "
88832|NCT02123316|"     To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in     the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in     symptom scores and medication use in the active group compared to placebo.      The influence of treatment in in vitro and in vivo objective parameters was also     assessed.   "
88833|NCT02123303|"     Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several     different underlying diseases, conditions, or combinations of medicines may contribute to OH;     therefore the cause of the condition varies among individuals. Some studies have shown that     OH is associated with an increase in the rate of death, but it is not clear what role OH     plays in increased morbidity. By studying what the prevalence of OH is in a generalized     veteran population we expect increase clinical awareness of the degree of the problem so that     patient care might be improved.   "
88834|NCT02123290|"     This will be a Proof-of-concept / Phase IIa, open label study to examine the efficacy of     DSM265 in uncomplicated Plasmodium vivax and Plasmodium falciparum blood-stage malaria in     adult patients. A minimum of two cohorts (20 patients) and a maximum of 6 cohorts (60     patients, 3 dose levels) will be tested. The starting dose of DSM265 for the first P. vivax     and P. falciparum cohorts will be 400 mg. This dose is expected to show complete clearance of     parasites by microscopy by Day 7 and a decrease in recrudescence rate assessed at Day 14     (success criteria for dose de-escalation and continuation of the study).   "
88835|NCT02123277|"     The study aim is to evaluate the tubal score on patients who suffer from obstructive     dysfunction of eustachian tube before and after the eustachian tube dilatation.   "
88848|NCT02123108|"     This is an investigator initiated study at the University of California, Los Angeles (UCLA)     funded by Novartis looking at using a combination of immunosuppressive drugs in liver     transplant patients that are at risk of developing kidney problems. Kidney problems following     liver transplants is the most problematic issue facing liver transplant patients today.      This study will generate information in this area of high unmet medical need utilizing     basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard     of care medications, after kidney function has normalized.      This study will enroll 60 subjects. 30 subjects in each of the two groups. Subjects will be     followed for 1 year after liver transplant.   "
89624|NCT02112994|"     This study will evaluate the safety and efficacy of sebelipase alfa in a broad population of     patients with lysosomal acid lipase deficiency (LALD).   "
88836|NCT02123264|"     The progression of structural joint damage is the leading cause of disability and     socioeconomic costs associated with rheumatoid arthritis (RA). Remission and low clinical     activity not always imply absence of progression of structural damage. The main objective of     this study is to evaluate the progression of radiological damage in early RA patients     currently treated with disease modifying anti-rheumatic drugs (DMARDs) and low disease     activity to which treatment with zoledronic acid is added.      The investigators propose a randomized clinical trial in 94 patients with RA of less than 2     years of evolution that, being treated with DMARDs, present criteria of low disease activity     (DAS28 < 3.2).      Patients will be randomized into two branches: zoledronic acid and no treatment. The primary     study endpoint is the progression of radiological damage assessed in a blinded way by the     difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two     years; the secondary variables: radiographic progression after one year, serum bone     biomarkers (OPG, RANKL, DKK-1 and sclerostin) and adverse effects. In a subgroup of patients,     the investigators shall evaluate the change in the size of hand erosions by multislice     computed tomography and the evolution of periarticular osteoporosis and systemic bone mass by     dual X-ray absorptiometry (DXA).   "
88837|NCT02123251|"     The purpose of this randomized controlled trial study is to examine the extent that financial     incentives when combined with diabetes evidence-based practices, improve self-management and     biometric measures for adult diabetic Medicaid recipients with an HbA1c of ≥ 6.5 at     enrollment. The study will also evaluate the cost-effectiveness of the program.      Specific Aims:        1. Evaluate whether financial incentives for completing ADA recommended tests, exams and          vaccinations will improve compliance rates.        2. Evaluate whether financial incentives for health education and biometric outcomes will          improve diabetes patients' self-management.        3. Evaluate the extent to which financial incentives for healthy behaviors reduce health          care utilization.   "
88838|NCT02123238|"     The study aims to evaluate the effect of non-supine positioning in the treatment of surgical     patients with obstructive sleep apnea. The hypothesis is that non-supine positioning will     result in a decrease in acute hypoxic events, defined as the number of apneas/hypopneas per     hour of sleep.   "
88840|NCT02123212|"     The Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C)     compares the effectiveness of the birth cohort HCV screening strategy with the current     risk-based screening approach to detect previous unidentified persons with viral hepatitis C     who receive health care in primary systems.      The study involved three clinical sites, The University of Alabama, Birmingham; The Henry     Ford Health System; and the Mount Sinai Medical Center, each of which developed an     independent intervention to experimentally compare the number of positive Hepatitis C Virus     (HCV) diagnoses found using the birth-cohort screening approach with that found using     traditional risk-based screening, or standard of care strategies. Birth cohort testing is     defined as the systematic recommendation of HCV antibody testing to any persons born during     the years of 1945 to 1965 who do not have clinically documented evidence of a prior antibody     test without regards to the patient's stated risk of exposure to the virus.   "
88841|NCT02123199|"     A prospective observational multi centre research study in GP practices clustered within up     to 10 UK Primary care trusts.   "
88842|NCT02123186|"     To test if the routine newborn screening dried blood spots can be used to test if missing 2     copies of SMN1 gene, a status indicating spinal muscular atrophy   "
88843|NCT02123173|"     Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management     of many lung conditions such as pneumothorax , lung volume reduction, pulmonary     metastasectomy, removal of lung nodules, segmentectomy and lobectomy. However, the     hemodynamic changes during one lung ventilation have not been fully investigated. The goals     of this study are to compare the changes of hemodynamics (including blood pressure, heart     rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung     ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic     (VATS) operations.   "
88844|NCT02123160|"     This study compares the effectiveness of Child Parent Psychotherapy to that of usual care     (defined as: referral to therapists in the community or Columbia University Medical Center)     in improving maternal depressive symptoms and child emotional and behavioral disturbances.     The investigators will recruit mothers who report being mildly to moderately depressed and     their preschoolers (ages 3-5 years) who they are concerned are exhibiting emotional and/or     behavioral problems.   "
88845|NCT02123147|"     Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland     dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry     eyes symptoms. It can be systemic by affecting other organs including the gastrointestinal     tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement of the musculature     can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of     patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic     neuropathies exhibited by cognitive impairments such as dementia, lack of concentration,     memory loss and various psychiatric disorders. Like most autoimmune connective tissue     diseases, SjS shows a sexual dimorphism with women affected 10-times more frequently than     men, suggesting a role for sex hormones in disease susceptibility or progression. One common     feature of SjS is it infiltration of mononuclear cells into the salivary and lacrimal glands,     aggregating into clusters referred to as lymphocytic foci (LF). Critical to the studies     proposed is the fact that a predominant cell population of LF is the pathogenic TH17 cell     that produces IL-17 cytokine and autoreactive B cells reactive to M3R, Ro, and La     autoantigens. The goal of this study is characterize the change in receptor gene repertoires     of autoreactive B and T cells at different time points during the disease process and examine     the correlation with various disease parameters.   "
88846|NCT02123134|"     The objectives of this study are to explore the safety and efficacy of subcutaneous     injections of ATX-101 relative to placebo, in the submental area of subjects who are 65 to 75     years old.   "
88847|NCT02123121|"     Resveratrol, a compound found in red wine and dark-skinned grapes, will improve the function     of mitochondria (energy producing components) within the leg muscles of moderate functioning     older adults.      The investigators will look at the role Resveratrol plays in improving physical function by     studying the connection of changes in mitochondrial function and changes in physical     function.   "
88849|NCT02123082|"     Urolithiasis (kidney stones) is a common disease process affecting people all across the     world. Usually, if the stone size is small, it is able to pass through the urinary system and     exit the bladder on its own with no treatment. However, when the size of the stone is bigger,     it can get trapped in the kidney or the ureter, causing significant pain for the patient and     potentially obstructing urine flow. If this occurs, surgical treatment is necessary for the     removal of the stone. The surgical procedure often employed involves the use of a     ureteroscope, which is a device that includes a camera and channels for working instruments     such as a grasper and laser fiber to be placed during a procedure. Ureteroscopes that are     currently in use are flexible and have the ability to treat stones that may otherwise be     inaccessible in the kidney. Most flexible ureteroscopes in clinical use currently only have     one channel therefore only allowing one instrument to be used at a time. Recently, a new type     of ureteroscope has been introduced in the market that offers the advantage of having two     working channels where two instruments can be inserted for use during stone treating     procedure. This can potentially decrease procedure time for patients affected by kidney     stones.      The purpose of this research is to compare the efficacy and safety of the ureteroscopes that     have only one channel for instrument insertion with the newer ureteroscope that has two     channels for utilization during stone treatment.   "
89055|NCT02120404|"     The purpose of this study is :      - to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart     rate of 10% or 20%.   "
88852|NCT02123043|"     Many older adults lack the skill of efficient wheelchair propulsion despite being the largest     cohort of wheelchair users. Inefficient wheelchair propulsion can lead to fatigue and overuse     injuries that can result in lost independent mobility. This study will evaluate the     effectiveness of a new training strategy using a motor learning based approach to train     efficient wheelchair propulsion. Participants will be randomly assigned to one of three     groups: 1) No practice; 2) Motor learning-based training; or 3) Practice (time-matched to     training). Potential improvements based on training will be explored for wheeling     biomechanical variables and energy efficiency.      Study Hypothesis: We expect that the Training intervention will be superior to the Practice     intervention for improving the biomechanical and physiological efficiency of wheelchair     propulsion. It is also hypothesized that both the Training and Practice interventions will be     superior to no practice.   "
88853|NCT02123030|"     Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds     (VOCs) in human exhaled breath for quantitative analysis of VOCs.   "
88854|NCT02123017|"     The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with     escalating doses of lactulose to be used as a preparation for colonoscopy.   "
88855|NCT02123004|"     1. Ticagrelor inhibits inflammation and improves vascular endothelial cell function to a          greater extent than clopidogrel in ST-segment elevation myocardial infarction(STEMI)          patients receiving percutaneous coronary intervention.        2. Ticagrelor can reduce the serum levels of inflammatory biomarkers both in coronary and          in peripheral venous in patients with ST-segment elevation myocardial infarction(STEMI).   "
88856|NCT02122991|"     Increased life expectancy in individuals with spinal cord injury (SCI) present clinicians     with the challenge of managing the secondary complications of SCI with the chronic diseases     common in an aging population. Cardiovascular disease, cerebral vascular disease, and     cognitive dysfunction are among the primary challenges facing clinicians in the treatment of     an aging population. Cognitive dysfunction has been reported in upwards of 60% of the SCI     population, which have been primarily attributed to concomitant traumatic brain injury or     pre-morbid conditions. Identifying possible modifiable risk factors which contribute to the     increased prevalence of cognitive dysfunction in the SCI population is of significant     clinical relevance and cardiovascular and cerebrovascular disorders have emerged as possible     contributors to the cognitive disorders in the general population. These risk factors     include: physical inactivity, chronically low or high blood pressure (BP), reduced blood flow     to the brain, arterial stiffening, and impaired nervous system regulation of the     cardiovascular system. These risk factors are particularly prominent in the SCI population as     they represent a model of profound inactivity, have trouble regulating blood pressure, and     suffer impaired cardiovascular regulation from their injury. In addition, we've recently     reported deficits in blood flow to the brain at rest and during cognitive tests; with results     being further impaired in SCI with chronically low blood pressure. Therefore the goals of     this project are to determine the influence of cardiovascular and cerebral vascular responses     at rest and during cognitive testing on test performance in 80 individuals with SCI compared     to 50 age-matched non-SCI controls. All potential subjects will undergo a rigorous two-part     screening process which consists of an initial screening via telephone and a detailed,     in-person screening. Eligible subjects will be invited to participate in a 3 hour laboratory     visit during which their arterial stiffness, blood pressure, heart rate, respiration rate     and, blood flow to the brain will be monitored at rest and during a comprehensive series of     cognitive tests.      We hypothesize that blood pressure and cerebrovascular response to testing will account     significantly for performance in cognitive testing that otherwise would have been     attributable to SCI status.   "
88857|NCT02122978|"     Increasing research evidence supports the effectiveness of mindfulness based interventions;     however, the exact mechanisms of change are poorly understood. Some evidence proposes that     self-compassion is an important mechanism of change in the effectiveness of mindfulness based     interventions. The current research will evaluate and compare the effectiveness of two     mindfulness meditation approaches; Mindfulness Based Cognitive Therapy (MBCT) and Mindfulness     based Self-compassion Therapy (MBSCT), for individuals with psoriasis, a skin condition     commonly associated with stress. Blood analyses will be conducted to assess and compare the     impact of the interventions on the immune system. Self-report questionnaires will explore     participants' psychological functioning (e.g. self-compassion, depression, anxiety, worry).     This study will also examine whether a relationship exists between immune functioning and     psychological factors. An audio-guided MBSCT programme will be piloted, with a view to     trialling as a more cost-effective alternative to traditional mindfulness interventions.     Findings will enable us to design more effective interventions in the future, and yield clear     results regarding the existence of a definite link between immunological functioning and     psychological functioning.      The main research hypothesis is that participants who complete a mindfulness based     intervention will experience significantly greater psychological well-being, symptom     reduction, and greater changes in telomerase and cytokine activity than individuals who only     receive treatment as usual for their psoriasis.   "
88879|NCT02122692|"     To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the     multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive     metabolisers).   "
88880|NCT02122679|"     Tranexamic acid is a relatively safe medicine that is used to help the body develop clots and     slow down bleeding after large surgeries. While it has already been shown to work well in     adults and older children, there is no information on whether it works, and how it works in     children younger than 6 months old. The goal of our study is to try and understand whether     and how tranexamic acid works in children younger than 6 months old who are having open heart     surgery.      We plan to study tranexamic acid by testing its effect when compared with a placebo. The     investigators will use a method called randomization - which means patients who agree to be     in the study will be entered into a computer. The computer will randomly assign them to     either receive the medicine or the placebo. We will then compare effects on the 2 groups of     patients. Our goal is to have 50 patients in each group, or 100 patients total. We will not     know whether patients receive tranexamic acid or placebo until we review the data collected     at the end of the study.      Tranexamic acid is usually given to patients in the operating room during open heart surgery.     During open heart surgery patients require cardio-pulmonary bypass which is a machine that     replaces the function of the heart and lungs for a short period of time. This allows surgeons     to do surgery on the heart itself without having to worry about it moving during the     operation. The bypass machine has lots of tubes to carry the blood around it. When blood     comes into contact with the tubing it has a tendency to clot. To prevent this patients are     given a blood thinner called heparin. Although heparin prevents clotting in the bypass     machine, it can also increase the risk of bleeding when the surgery is over. To reduce this     risk patients are given another medicine at the completion of surgery called protamine to try     and reverse the effect of the blood thinner, heparin.      Even so bleeding remains a significant problem, especially for babies after open heart     surgery. Being on the bypass machine and having a lot of suture (stitches) lines increase     that risk. In addition, the bypass machine affects the function of platelets, the main     component of the body's clotting system. We often have to replenish blood products after     surgery to try and stop the bleeding. Some centers, including we , have used the medicine     tranexamic acid to try and help with bleeding after surgery. There have been other studies     that show it helps with fibrinolysis, which is another important part of the body's clotting     system. However, that part of the clotting system is not well developed in infants and     therefore likely does not play an important role in preventing bleeding in that age group.      As such, it may be that tranexamic acid impacts platelet function as well, and it is that     effect that helps decrease post-operative bleeding in infants younger than 6 months. This has     not been previously studied. In order to study the effect that tranexamic acid has on     platelets the investigators are proposing the investigators' research trial. The     investigators plan to randomize patients to either receive tranexamic acid or placebo in the     operating room as described above. The investigators will then draw a small amount of blood     from each patient (total of approximately 1 tablespoon) and send it to a special lab for     testing of platelet function. The lab test will help us understand whether the platelets     function better when patients receive tranexamic acid instead of placebo.      The investigators will also be monitoring other outcomes related to platelet function. These     will include how much bleeding patients have after surgery when they are in the intensive     care unit, and how much blood products they require to treat that bleeding. The investigators     will also monitor labs that are checked routinely in all patients after open heart surgery.     The investigators will also track how long it takes each patient to get off the ventilator     and how long they spend in the ICU after surgery. All of this data will help us understand     whether tranexamic acid makes a positive impact on outcomes after open heart surgery in     infants less than 6 months old.      The current standard of care is quite variable within our institution as well as at other     institutions. Some anesthesiologists use tranexamic acid while others elect not to. There is     no definitive guideline to its current use. The dosing differs from center to center, and     there are some centers that do not use it at all.      The investigators' hope is that the results of this study will help us understand the role     tranexamic acid plays in preserving the function of platelets after open heart surgery in     young infants, and whether that impact translates into improved outcomes for those patients.     Based on the results of our research we hope to develop definitive guidelines for the use of     tranexamic acid in the population of infants <6 months old undergoing open heart surgery.   "
88881|NCT02122666|"     The investigators previous research has suggested that lipid (fatty) composition in the     muscle cells of mice plays a key role in their insulin sensitivity. The purpose of this study     is to determine whether these specific fat signatures translate to humans by comparing the     muscle of healthy patients to those with pre-diabetes, or the metabolic syndrome.   "
88858|NCT02122965|"     Adverse drug events are unintended and harmful events related to medication use and a leading     cause of emergency department visits, unplanned hospital admissions and deaths. In the     emergency department, physicians frequently misdiagnose adverse drug events leading to     treatment delays. Our objective is to evaluate the effect of pharmacist-led medication review     in high-risk emergency department patients on prolonged hospital stay.      This prospective multi-centre, quasi-randomized study is nested within an existing quality     improvement program. Triage nurses flag incoming emergency department patients at high-risk     for adverse drug events by applying a clinical decision rule consisting of four variables     (co-morbid conditions, antibiotic use within 7 days, medication changes within 28 days, and     age). Consecutive eligible high-risk patients are enrolled into the medication review study,     and systematically allocated to pharmacist-led medication review or usual care. In the     intervention group, medication review pharmacists collect best-possible medication histories,     review the patient's medications for appropriateness and adverse drug events, and communicate     the results of medication review to patients, caregivers and physicians. In the usual care     group, physicians refer patients to onsite pharmacists for medication management questions on     an as needed basis. Health outcomes are assessed using anonymized data linkage to     administrative health databases. The primary outcome is the percent of days spent in hospital     during the first 30 days after the index emergency department visit   "
88859|NCT02122952|"     The purpose of this trial is to evaluate safety and efficacy of intravenous delivery of     AVXS-101 as a treatment of spinal muscular atrophy Type 1 (SMN1).   "
88860|NCT02122939|"     An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the     effect on ECG of escitalopram after oral administration in elderly volunteers.   "
88861|NCT02122926|"     The goal of this study is to design and implement an intensive discharge intervention for     inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the     intervention on post-discharge insulin adherence, glycemic control, cardiac medication     adherence, hypoglycemic events, and emergency department visits and hospital readmissions.   "
88866|NCT02122861|"     This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of     ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel     immunotherapy agent designed to target dendritic cells and stimulate the body's immune system     to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1     protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that     express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305     with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1     therapy.   "
88867|NCT02122848|"     The purpose of this study is to evaluate the effects of airway bilevel positive pressure on     the improvement of exercise tolerance in patients with decompensated heart failure.   "
88868|NCT02122835|"     The purpose of this study is to understand the differences in how patients with heart failure     respond to exercise training compared to patients with heart failure and type 2 diabetes.   "
88869|NCT02122822|"     RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help     the body build an effective immune response to kill tumor cells.      PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of     glioblastoma and to see how well it works in treating patients with newly diagnosed     supratentoria glioma.   "
88870|NCT02122809|"     The purpose of this dose-escalation study is to assess the safety and tolerability of     treatment with Chiauranib administered orally over a range of doses in patients with advanced     solid tumors.   "
88871|NCT02122796|"     The purpose of the study is to compare the effect of acupuncture to the standard of care     (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay     in post-mastectomy patients at Abbott Northwestern Hospital.   "
88872|NCT02122783|"     The purpose of this study is to evaluate how two different settings of a commercially     available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot     orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in     addition to the conventional hard stops, to limit the range of motion of the ankle during     walking. The results of this study will help to clarify 1) whether and how this new joint     affects the way you walk, 2) whether it makes it easier for the clinician to align your brace     and 3) your opinions about the new joint.   "
88873|NCT02122770|"     The primary purpose of this study is to assess the effect of multiple-dose administration of     fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and the     effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.   "
88874|NCT02122757|"     Anodal tDCS increases the excitability of the cerebral cortex and its daily application     during intercritical phase, may have a therapeutic effect in episodic migraine.   "
88875|NCT02122744|"     Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic     migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease     the frequency of migraine and if its effect is stronger than placebo effect.   "
88876|NCT02122731|"     To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy     in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)   "
88877|NCT02122718|"     Recurrent stroke and cognitive decline are common after ischaemic stroke. Allopurinol, a drug     usually used to treat gout, has been shown to reduce heart ischaemia, heart size, and     arterial stiffness and to relax brain blood vessels and may reduce the blood pressure. All of     these properties may be associated with a lower risk of second stroke and cognitive decline.     We now aim to explore whether allopurinol will reduce further damage to the brain (called     white matter hyper-intensities) after stroke and also whether it reduces heart size and blood     pressure after stroke.      We will conduct a multi-centre randomised, double-blind placebo controlled study to     investigate whether two years allopurinol 300 mg twice per day (BD) improves these 3     outcomes, which are inextricably linked to risk of recurrence and cognitive decline after     ischaemic stroke.   "
88878|NCT02122705|"     This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm     which would benefit labouring mothers who are unable or unwilling to receive epidural     analgesia.   "
88882|NCT02122653|"     Muscle strength and endurance are important indexes of fitness. The muscle strength is the     most important single predict factor of functional ability in aged frail individuals. Frailty     related muscle weakness and fatigue are adapted from the pre-frail stage. Finding the     contributions of the central and the peripheral factors to the deficits of muscle fitness and     developing an effective muscle fitness training program for pre-frail individuals are very     important.      The muscle weakness and fatigue can be categorized into peripheral or central causes. The     central fatigue and voluntary activation failure originate from the decrease in motivation or     the reduction of the conduction within corticospinal tracts. Long term activation failure and     central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral     fatigue. Studies found the selective type II fiber atrophy in aged people and this finding     was different from the type I atrophy in conventional immobilization models. It is possible     that the activation failure leads to the recruitment failure of high threshold type II fibers     at the pre-frail stage. Quantifying the weighting of central versus peripheral factors     contributing to the exercise limitation in pre-frail people is important.      Most of the conventional strength and endurance training programs are based on the researches     of young groups. These programs are not able to prevent people become frail. It is possibly     that, due to the limitation of central fatigue, the pre-frail individuals stop exercise     before the effective intensity being achieved. Almost no training program has been design for     enhancing the voluntary activation level and relief the central fatigue. Seeking an     appropriate training program to enhance central activation at the pre-frail stage is very     important for preventing people become frail.      Previous studies have shown that increasing afferent input by peripheral electrical     stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary     sensory cortex, the excitability of corticospinal tracts, and the functional performance in     young adults. ES, which is easy to quantify the dose of afferent input, is a feasible method     to be used in training. Combining afferent input with strength training might be able to     overcome the central activation failure and help recruit high threshold motor unit in     pre-frail individuals.   "
88923|NCT02122120|"     Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with     the ongoing economic crisis influencing health care, its cost-effectiveness has been     questioned recently.      Objective: The unique reimbursement situation in Poland enabled the otherwise ethically     unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term     feeding and the subsequent analyses of the clinical value of the latter and its     cost-effectiveness.   "
88883|NCT02122640|"     LUNG ULTRASOUND IN THE MANAGEMENT OF DISPNEIC PATIENTS IN EMERGENCY DEPARTMENT      Introduction      This is a prospective randomized trial realized in the Emergency Department of the University     Hospital of Siena, Italy.      Dyspnea is one of the most common causes worldwide of admission to the Emergency Department     (ED) and acute heart failure (AHF) is a major cause of serious morbidity and death in such     population, above all in elderly patients. Incidence rate is signiﬁcantly higher in men than     in women, in Europe it increases with age from 1.4/1000 person-years in subjects aged 55-59     years to 47.4/1000 person-years in those aged 90 years or older. The age-adjusted prevalence     of AHF in the United States averages 36 cases per 100,000 of the population and accounts for     10,000 deaths annually.      In clinical practice this symptomatology is usually investigated in the pre-hospital phase     only with history and physical examination; in the ED blood gas analysis (BGA), laboratory     tests and chest X-rays can be performed as primary exams. BNP and NT pro-BNP are now     considered reliable biochemical markers to distinguish cardiogenic from pulmonary etiology,     both for their diagnostic and prognostic value. On the other hand, these biomarkers are     affected by a grey zone of uncertainty, they are not available in all hospitals and their     dosage samples are expensive: thus we propose other tools to support the diagnostic process.   "
88884|NCT02122627|"     Vitamin D has an immunomodulatory role. the aim of the present study is to assess the effect     of vitamin D supplementation on exacerbation rate of COPD patient with a vitamin D     deficiency.   "
88885|NCT02122614|"     The aim of this randomized controlled trial is to investigate the effects of adding PA     monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary     rehabilitation (PR) program on daily PA levels and health status of patients with COPD.      Patients will be randomized to either receive a PR program with PA monitoring and regular     feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]).     During the PR program, patients in the EG will receive a pedometer to self-monitor their PA     and individualized step-count goals. They will continue to use the pedometers and receive     individualized goals for 3 months after the program.      It is expected that, by receiving individualized goals and a simple pedometer to self-monitor     their PA during and after a PR program, patients with COPD will become more active and adhere     to long-term rehabilitation, thus reducing the overall impact of COPD.   "
88886|NCT02122601|"     To assess the safety and efficacy of LBSA0103 (BDDE cross-linked sodium hyaluronate gel) when     it is administered for the second time 26 weeks after its first administration in patients     with osteoarthritis of the knee.      The Safety and efficacy of 26weeks after its first administration will be also evaluated.   "
88887|NCT02122588|"     This is a multicentre, non-interventional, prospective study to be carried out in     representative hospitals in order to assess 1st line treatment management and diagnostic     approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and     assess patients` characteristics and the occurrence of BRCA (Breast Cancer gene) mutations     among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube     cancer. No additional procedures besides those already used in the routine clinical practice     will be applied to the patients. Treatment assignment will be done according to the current     practice.   "
88888|NCT02122575|"     Background:      - Restricting calories can help a person reduce risk factors for heart disease. Researchers     have found that not eating or drinking anything but water for 24 hours prevents the     activation of a component of the immune system, called the inflammasome. The inflammasome is     associated with the development of diabetes and heart disease. Researchers want to learn more     about the body s response to fasting.      Objective:      - To explore the benefits of calorie restriction on heart health.      Eligibility:      - Healthy adults ages 21 32 with a body mass index between 26 and 29.      Design:        -  Participants will be screened with a medical history, physical exam and blood test.        -  Participants will not eat or drink after 10 p.m. before their first visit.        -  Participants have breakfast at the clinic. The breakfast will be about 500 calories.          Then they will not eat or drink (except water) for 24 hours.        -  Participants will return to the clinic the next morning. They will have blood drawn.          Then they will have breakfast. Blood will be drawn again at 1 hour and 3 hours after the          meal.        -  Blood and urine tests at the end of the fast and following the meals will be done to          confirm that participants have fasted for the full 24-hour period.   "
88889|NCT02122562|"     Objective:      Glutamate-based medications including the N-methyl-D-aspartate (NMDA) receptor antagonist     ketamine result in rapid, robust and sustained (up to one week) antidepressant effects in     randomized controlled trials in treatment-refractory unipolar and bipolar depression.     Previous work by our group has demonstrated that a family history of alcohol dependence     predicts a more robust antidepressant response to ketamine in both treatment-resistant     unipolar and bipolar depression.      Recently-detoxified alcoholics and affected first-degree relatives display blunted     psychotomimetic, cognitive and other neuropsychiatric effects with a subanesthetic dose of     ketamine. Also, a family history of alcoholism alone predicts differential response to     intravenous alcohol. Based on our prior post hoc results, we seek to prospectively     demonstrate that a family history of alcohol dependence predicts a more robust antidepressant     response to ketamine. We will also explore potential biomarkers of ketamine s antidepressant     effects in treatment-refractory depressed patients at risk of alcohol dependence (using     physiological and neurochemical responses to alcohol).      Study Population:      21-65 year old treatment-resistant major depressive disorder without psychotic features     patients in a current major depressive episode of at least moderate severity will be     recruited and enrolled in this protocol. All subjects must also be free of a lifetime     substance use disorder diagnosis with the exception of a nicotine or caffeine use disorder)     and will be psychotropic medication-free for at least two weeks prior to the first alcohol     infusion. Our targeted number of completers will be 50 depressed subjects (60 signing consent     to account for attrition): 25 FHP subjects [as defined by either one first degree relative or     two second-degree relatives with alcohol dependence on the Family Interview for Genetics     Studies (FIGS) and Family Tree Questionnaire (FTQ)] and 25 FHN negative subjects.      Design:      This study is a single-site, open-label protocol in psychotropic medication-free depressed     subjects admitted to the Clinical Research Center s Mood and Anxiety Disorder Inpatient     Research Unit (7-SE). This protocol consists of two phases (Phase I and Phase II). The first     phase consists of the medication taper and drug-free period. The second phase will have three     subphases: Subphase IIA ( alcohol clamp infusion #1 with neurophysiological assessments), IIB     ( alcohol clamp infusion #2 during 7 Tesla-Magnetic Resonance Spectroscopy/Imaging     (7T-MRS/I)) and IIC (subanesthetic/antidepressant dose ketamine infusion during 7T-MRS/I).      Outcome Measures:      The primary hypothesis/outcome measure will be change in mean Montgomery-Asberg Depression     Rating Scale (MADRS) total score from the pre-ketamine infusion baseline-to-7 days     post-infusion between the FHP and FHN groups. Other exploratory measures include     neurophysiological responses to intravenous alcohol infusion, brain neurochemical alterations     during intravenous alcohol infusion, brain neurochemical alterations during intravenous     ketamine infusion and resting state (task-free) functional magnetic resonance imaging as a     function of family history of an alcohol use disorder.   "
88890|NCT02122549|"     This study will obtain device-human interaction evaluations for the HWD1000 within the     controlled environment of the hospital as well as establish that the safety profile is     similar to outpatient wearable cardioverter-defibrillators use.   "
88892|NCT02122523|"     The sentinel lymph node (SLN) procedure is a standard staging technique in several types of     cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an     optimal dye and technique for identification of the nodes. In this study the investigators     used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly     developed NIR laparoscope. The investigators compared two different injection techniques;     subserosal and submucosal injection.      Patients planned for a laparoscopic resection of a colorectal carcinoma without distant     metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten     minutes after injection the investigators searched for fluorescent nodes with the NIR     laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H&E and     additional immunohistochemistry.   "
88893|NCT02122510|"     In this study, the investigators will compare the analgesic effect of bupivacaine and     bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP     block, on the patients for whom the operation will be performed under general anesthesia.   "
88960|NCT02121639|"     The aim of the ProCAID study is to determine if the addition of the AKT inhibitor AZD5363 to     docetaxel and prednisolone (DP) prolongs progression free survival (PFS) in Metastatic     castration resistant prostate cancer to a degree worthy of further investigation   "
89056|NCT02120391|"     The purpose of this study is to assess an iPhone application to increase adherence to     maintenance medications in subjects with ulcerative colitis.   "
88894|NCT02122497|"     The aim of the present study is the evaluation of cardiovascular biomarkers in patients with     abdominal aortic aneurysms (AAA) or abdominal aortic occlusive disease AOD) undergoing open     (OR) or endovascular aortic repair (EVAR) with regards to short- and long-term outcome.      By blood collection and measurement of the serum biomarkers Copeptin, N-terminal- pro Brain     Natriuretic Peptide (NT-proBNP), cardiac Troponin I (cTnI), high sensitive Troponin T     (hs-cTnT) and C-reactive Protein (CRP) we expect an improvement of patients stratification by     assessment of cardiac stress tolerance. Data gathered may help to simplify the decision     whether an open or endovascular approach for abdominal aortic repair (OR and EVAR) should be     performed.      Study Hypothesis:      The evaluation of the predictive value of cardiovascular biomarkers (Copeptin, NT-proBNP,     hsTnT, cTnI, CRP) improve patient stratification and selection of surgical treatment.   "
88895|NCT02122484|"     There is evidence that inflammatory processes may play a key role during surgical myocardial     reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may     lead to reduction in periprocedural infarct size, when administered during elective coronary     artery bypass graft surgery.   "
88896|NCT02122471|"     The purpose of this study is to confirm that the investigational medication, plecanatide, is     safe and effective in treating chronic idiopathic constipation.   "
88897|NCT02122458|"     The purpose of this study is to study blast-exposed Veterans who report hearing handicap but     show normal or near normal results on standard audiometric testing. The characteristics and     nature of their auditory and auditory-related skills will be examined, along with whether     coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary     treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids to     determine if they benefit from low-level amplification of high-frequency sounds.   "
88898|NCT02122445|"     Low back pain is a problem which affects up to 70-80% of people in their lifetime. In the     United States, it is estimated that the total direct and indirect costs of low back pain     combined ranges from $19.6 to $118.8 billion. Recent studies have shown the importance of the     gluteal musculature in the treatment of low back pain. It was found that the gluteus maximus     (Gmax) is significantly more active in a low back pain population compared to a healthy     population, indicating the low back pain population relied on the Gmax to fire more to     overcome the gluteal weakness. A new approach to treating musculoskeletal conditions is a     taping technique designed to target muscles and lymphatic system. Limited research is     available for the treatment of specific conditions, including low back pain, but it is     theorized to inhibit or facilitate the muscle, improve blood flow, reduce pain, and improve     joint alignment. Methods: The purpose of this study is to determine the immediate and delayed     effectiveness of Cramer® Sports Motion Tape on Gmax and lumbar paraspinal activation in a     chronic mechanical low back pain population. A convenience sample of 20 new patients with     current, chronic low back pain, no current neurologic signs or symptoms, no previous spinal     surgery, no corticosteroid treatment within the last two weeks, and who are not pregnant will     be recruited for this study. Patients will sign an informed consent, complete all initial     paperwork. Surface electromyography will be used to quantify the activity level of the Gmax     and lumbar paraspinals (LP). The MVIC will be estimated for each muscle group and the patient     will perform a series of 4 randomized exercises, 5 repetitions each; Clams with Resistance,     Standing Hip Abduction with Resistance, Sidelying Hip Abduction, and a forward bend. After     each exercise the patient will rate How hard they are working on the RISE scale. Following     the initial test, Cramer® Sports Motion Tape will be applied to the gluteal and low back     area. After the tape is applied, the EMG exercise protocol will be repeated. The tape will be     left on until the patient returns for their next appointment, within 24 to 48 hours, where     they will have a delayed post-test. Patients will rate their pain, surface electrodes will be     applied to the previous testing sites, and MVIC will be retested for each muscle group. The     patient will perform the same protocol that was performed in the initial testing session. The     EMG signals will be smoothed, rectified and analyzed using a root-mean-square algorithm. The     investigators will use visual onset and offset of the EMG signal amplitude to select the     middle 3 trials. Average activation and peak activation will be determined and compared to     the MVIC for each muscle group, and expressed as a %MVIC. This will allow %MVIC to be     compared and rank order among groups and muscles.   "
88899|NCT02122432|"     In France, there is usually a long delay (approximately 6 weeks) before a general     practitioner can obtain a specialized advice by dermatologists for diagnosis of unusual     dermatologic conditions of their patients.      Previous studies have shown that teledermatology is a reliable way for diagnosis in     dermatology.      We hypothesize that a teledermatology advice could reduce delay before diagnosis and     therefore treatment for patients.   "
88900|NCT02122419|"     We aimed to investigate the association between the position in which spinal anesthesia was     performed and postdural puncture headache occurrence.   "
88901|NCT02122406|"     The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive     disorders, and their relationship with disease activity, in patients with rheumatoid     arthritis treated with biological drugs   "
88902|NCT02122393|"     Th purpose of this study is to determine whether dual psychological and pharmacological     treatment is superior to either mono-therapy alone in the treatment of postnatal depression.   "
88967|NCT02121548|"     Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened     for cervical cancer than the general population. One promising approach is outreach     strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW     programs, many women remain unscreened. In our NCI Community Networks sponsored project, we     are testing an approach that combines CHWs with self sampling for the human papilloma virus     (HPV) as a screening strategy among such hard to reach populations.   "
88903|NCT02122380|"     Adults with abdominal obesity are at high risk for cardiovascular disease and also exhibit     diminished growth hormone (GH) secretion; the latter further contributes to the development     of visceral adiposity, impaired fibrinolysis and inflammation.Growth hormone releasing     hormone (GHRH), the primary stimulus for endogenous GH secretion, is a substrate of     dipeptidyl peptidase 4 (DPP4); inhibition of DPP4 with the currently available anti-diabetic     therapy, sitagliptin, may therefore increase GH secretion by decreasing the degradation of     GHRH. The proposed research will test the hypothesis that chronic sitagliptin therapy will     enhance GH secretion and vascular function while improving glucose tolerance in patients with     impaired GH secretion who are at risk for the development of diabetes mellitus and     cardiovascular disease, specifically obese women with polycystic ovary syndrome.   "
88904|NCT02122367|"     Appropriate indices to guide fluid therapy are essential for effective hemodynamic management     during the perioperative period. Values derived from respiratory changes in arterial pressure     waveform or plethysmographic waveform such as stroke volume variation and pleth variability     index have been demonstrated to be able to predict fluid responsiveness in surgical or     critically ill patients. Their ability to predict fluid responsiveness can be affected by     factors that influence the arterial tone or the compliance of the respiratory system by     position change. The aim of this prospective trial is to investigate the ability of stroke     volume variation and pleth variability index to predict fluid responsiveness in the reverse     trendelenberg position.   "
88969|NCT02121522|"     The present trial will use an open label design to investigate the effect of BI 144807 on     central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD     patients. A further objective is to collect data on adverse events, vital signs, ECG and     clinical laboratory parameters of BI 144807 in the same patient group.   "
91388|NCT02089893|"     The purpose of this study is to analyze the retinal arteries, to investigate the incidence,     number, types, distribution and localization of cilioretinal arteries in the Hungarian     Caucasian population.   "
88905|NCT02122354|"     The objective of this research is the accumulation of gameplay data and simulator sickness     background surveys for trend analysis, and individual simulator sickness trigger factor     analysis for the test subjects involved. Rather than isolating specific variables for     hypothesis formulation, this study will be attempting to collect an array of data that is a)     both qualitative and quantitative, and b) observational and test subject-reported. The final     results will consist of a list of possible trigger factors to avoid for individual subjects,     and metrics showing the directional tendencies of players depending on the severity of their     symptoms at the time.      The overall goal of this research is to better understand factors that contribute to     simulator sickness, both in who it affects and why some gameplay experiences may cause it     more than others. Operating from the basic assumption that the way a player moves through an     environment affects how quickly that player gets sick, we will primarily be gathering data on     how the player moves through the digital space and whether that behavior changes once they     begin to feel sick.   "
88906|NCT02122341|"     The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is     intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.   "
88907|NCT02122328|"     The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using     sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant     method, selective laser photocoagulation of communicating vessels (SLPCV), may provide     vascular stability to the donor fetus. The primary objective is to evaluate the perinatal     outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a     prospective, randomized trial.   "
88908|NCT02122315|"     Fractures of the proximal humerus account for between 5% and 8% off all reported fractures.     Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft     tissues surrounding the shoulder area can be damaged. The purpose of the current clinical     trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain     and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure     for proximal humeral fixation or rotator cuff tear repair.   "
88909|NCT02122302|"     This investigation develops an online, patient self-assessment system, called CarePrep to     support the care and clinical research of patients with chronic pancreatic disease and     chronic pancreatic pain. This web-based assessment presents patients with questions that     address medical, psychological, social, behavioral, and quality-of-life issues that are     relevant to pancreatic disease. Patients will be given the opportunity to enter and track     their symptoms over the Internet from home or clinic. The system is also designed to gather     clues to identify neuropathic pain, which occurs when the nervous system fails to properly     regulate pain signals. Any of these factors can contribute to chronic pain and may point the     way to more effective treatment. The broad objective of this study is to extend CarePrep to     cover a full range of topics that are relevant to chronic pancreatic disease. The study team     will refine this content based on the system's accuracy in real clinical settings and direct     efforts to maximize its feasibility.   "
88910|NCT02122289|"     Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity.     Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship     between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present     health costs burden leading to important physical psychological and social impact. Preventing     exacerbation and early detection of these exacerbations may decrease intensity and freqauency     of exacerbation leading to increase clinical status and QoLwith a decreased health cost.      Patients actually follow in CRCM track exacerbations when visits out patient clinic and     during phone call. If patients did not call or did not present regularly to out patient     clinic, exacerbation detection came later and so increasde the burden and therapeutic     pressure.      The objective of our study is to identify earlier the potential exacerbations and so     decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use     modern technologiessuch as smartphone in order to create alert when patients report weekly     health satatus. We will compra patients randomize in control group with standart follow-up to     patients randomize in the smartphone group.Moreover we will study the compliance and     satisfactory degree of the use of this device in the interventional arm.   "
88911|NCT02122276|"     In animal and human studies, histochemical and physiological evidences showed that the muscle     transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord     injury. The alternation of muscular property was accompanied by the alternation of spinal     circuitry property, and was related to the immobilization adaptation. Previous study showed     that remobilization by continuous passive motion (CPM) for one month would restore the     function of spinal circuitry in individual with chronic SCI. It is possible that long term     application of CPM can reverse the adaptation of contractile properties of the paralyzed     muscle after SCI. The purpose of this study is to investigate the effect of a four month CPM     training on muscular properties in individuals with chronic SCI.   "
88912|NCT02122263|"     To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and     on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.   "
88913|NCT02122250|"     This project will address vital questions regarding how best to design web-based materials     for the growing population of patients with basic literacy and computer skills but lower     levels of health literacy, building on our previous experience of developing web-based     materials for people with lower levels of literacy and health literacy.      This study will be carried out two phases. Phase 1 will use qualitative methods to understand     user experiences of the web-based materials through observational 'think-aloud' interviews     with users. Phase 2 will test the newly developed web-based materials to a static     (non-interactive) version of the materials online.   "
88914|NCT02122237|"     Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application     during intercritical phase, may have a therapeutic effect in chronic migraine.   "
88970|NCT02121509|"     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose     combination (FDC) tablet containing linagliptin and metformin extended release compared to     the free combination of linagliptin and metformin extended release.   "
91726|NCT02085460|"     To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced     oral mucositis in patients with head and neck cancer following administration of rebamipide     and to determine the optimal dose of rebamipide.   "
88915|NCT02122224|"     One important factor determining school performance is the consumption of breakfast. While     research has shown that older children perform better in school after consuming breakfast,     there are little data for preschool-age children. Consuming breakfasts with different macro-     and micronutrient contents may have different effects on performance, which may be associated     with variations in satiation and satiety during and after the different breakfasts. In     addition, children who consume breakfast have better diet quality than children who skip     breakfast.      The investigators will conduct a community based, randomized, crossover trial in 4-5 year old     children over 7 weeks to examine the short-term effect of feeding preschoolers three     different intervention breakfast types: high protein, high-fiber, or high protein and high     fiber compared to a usual breakfast served at the preschool. The investigators expect that     the children consuming any of the three experimental breakfasts will consume less overall     calories and have better diet quality and memory performance compared to children who have     the usual breakfast. The investigators hypothesis is that preschoolers will experience the     highest level of satiety as well as highest level of overall diet quality when they consume     the combined high-protein and high-fiber based breakfast foods.      This study will be conducted at Bauer Family Resources in Lafayette as these are the sites of     Head Start programs, which are preschools for children from low-income families. Children     from families of low income are more likely to have poor diet quality and poor school     performance compared to children from families with higher incomes. Therefore, this     population is most in need of this type of intervention.   "
88916|NCT02122211|"     The ability of sperm to swim is important for normal fertility. Men with a genetic variation     in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by     sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient     called betaine (found normally in the diet as a part of many foods such as spinach, beets and     grain products). This study tests whether treatment with betaine is safe and whether it can     normalize energy production in sperm of these men and restore normal swimming ability.   "
88917|NCT02122198|"     Complaints about memory and thinking are common in women as they go through menopause and     estrogen levels fall. The ovarian hormone estrogen is important for supporting normal     cognitive function, and changes in brain activity and function occur when estrogen levels are     decreased. Estrogen is also important for maintaining healthy blood vessels which also     support normal cognitive function. In Alzheimer's disease and other types of dementia, there     is significant damage to the blood vessels in the brain. This study will test whether changes     in brain activity and function with the loss of estrogen are related to changes in vascular     function. We will measure vascular function using ultrasound, and brain activity using MRI     scans in women who are enrolled in the Females, Aging, Metabolism and Exercise (FAME) study     (NCT01712230). In the FAME study, healthy premenopausal women either take a medication to     decrease their estrogen levels, or a placebo. This sub-study may provide new information     about how estrogen affects vascular function and cognitive function, and lead to new ways to     prevent or delay cognitive impairment or dementia.   "
88918|NCT02122185|"     This randomized phase II trial studies how well metformin hydrochloride and combination     chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary     peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may     help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive     to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving     metformin hydrochloride may help doctors learn more about the effects of metformin     hydrochloride on cells. It may also help doctors understand how well patients respond to     treatment. Giving metformin hydrochloride together with combination chemotherapy may kill     more tumor cells.   "
89625|NCT02112981|"     meriT-V is a Prospective,active control open lable clinical trial to compare safety &     efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random     assignment for treatment of coronary artery disease at multiple multinational centres.   "
88920|NCT02122159|"     Pathologic myopia is a major cause of legal blindness worldwide. In myopic macular     degeneration (MMD), there is degeneration of the retinal pigment epithelial (RPE) layer, and     associated photoreceptors, resulting in vision loss. There is currently no standard treatment     for MMD.      Transplantation of intact sheets of RPE and suspensions of isolated individual RPE cells as     well as autologous translocation of RPE cells has been attempted as treatment for AMD. Human     photoreceptors are comprised of two cell types-rods and cones. Both have a close relationship     with the outermost retinal cells, the retinal pigmented epithelium (RPE). The RPE is located     between the choroid and the photoreceptors. The RPE maintains photoreceptor function by     recycling photopigments,delivering, metabolizing and storing vitamin A, phagocytosing rod     photoreceptor outer segments, transporting iron and small molecules between retina and     choroid, maintaining Bruch's membrane and absorbing stray light to allow better image     resolution. In essence, the RPE layer is critical to the function and health of     photoreceptors and the retina as a whole.      Human PRE (hRPE) transplantation may be a viable option for treatment of degenerative     diseases of the retina.      MA09-hRPE cells are fully differentiated human RPE cells derived from embryonic stem cells.     Transplanted hRPE cells prepared by Advanced Cell Technology have been studied in rodent     models of macular degenerative disease. The data suggests that the subretinal injection of     ACT's hRPE cell products rescues, or at least delays, loss of visual function in two animal     models of retinal degenerative diseases.      The main purpose of this study is to evaluate the safety and tolerability of MA09-hRPE     cellular therapy in patients with Myopic Macular Degeneration (MMD). Another objective is to     evaluate potential efficacy endpoints to be used in future studies of RPE cellular therapy.   "
88921|NCT02122146|"     To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients     with advanced solid tumors in order to determine the maximum tolerated dose and select the     recommended Phase 2 dose.   "
88922|NCT02122133|"     The primary objective of this study is to gather data on the radiation exposure in patients     treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their     respective indications for use.This is a multicenter case review study of patients presenting     with intracranial aneurysms who are treated with coil embolization therapy using the PC 400     or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated     with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.   "
90918|NCT02096055|"     The goal of this clinical research study is to compare different treatment schedules using     the drug SGI-110 alone or in combination with other drugs. Researchers want to learn more     about how these different treatment schedules may help to control AML. The safety of these     treatments will also be studied.   "
88924|NCT02122107|"     In this study,the investigators are looking to see how older women who are survivors of     breast cancer and either did or did not receive chemotherapy are affected by treatment,     compared to older women who have never had cancer. Thinking and memory abilities normally     decrease with age and the investigators want to see if the long-term effects of cancer     treatments may make these problems worse. The investigators will also look at how thinking     and memory abilities of older women are affected by genetics and smoking history. Genetics     and other factors may affect the brain's chemicals or structure, and may either protect     against the negative effects on thinking or make someone more at risk for them.   "
88925|NCT02122094|"     This study seeks to implement a sexual health promotion intervention for male sex workers in     Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will     increase testing, treatment and vaccination for sexually transmitted infections, including     intentions of participants to engage in these services beyond the conclusion of the     intervention. At the community level, the study hypothesis is that male sex workers will be     more aware of sexual health care and more likely to access these services in the future.   "
88926|NCT02122081|"     This pilot clinical trial aims to assess feasibility and tolerability of using an LINAC based     organ-sparing marrow-targeted irradiation to condition patients with high-risk     hematological malignancies who are otherwise ineligible to undergo myeloablative Total body     irradiation (TBI)-based conditioning prior to allogeneic stem cell transplant. The target     patient populations are those with ALL, AML, MDS who are either elderly (>50 years of age)     but healthy, or younger patients with worse medical comorbidities (HCT-Specific Comorbidity     Index Score (HCT-CI) > 4). The goal is to have the patients benefit from potentially more     efficacious myeloablative radiation based conditioning approach without the side effects     associated with TBI.   "
88927|NCT02122068|"     Family dementia caregivers provide a needed service to relatives with dementia and to     society, but are often at risk for consequences to their own health such as depression,     reduced immune system function, and burnout. Central Meditation and Imagery Therapy (CMIT) is     a novel group mindfulness and guided imagery intervention designed to help caregivers reduce     depressive symptoms and cope with the stress of caregiving. A small study suggested that CMIT     techniques are feasible for dementia caregivers, and resulted in a reduction of depressive     and anxiety symptoms. The largest benefits were shown to occur within the first 4 weeks, and     were maintained at 3 months post treatment. The early benefits of CMIT were further described     in a recent trial of CMIT for patients with recurrent depression, which demonstrated     promising improvement in depressive symptoms, with the largest benefits occurring within the     first 4 weeks. We have therefore shortened CMIT for caregivers from 8 weeks to 4 weeks, and     aim to study the effects of the four-week version (Central Meditation and Imagery Therapy,     Short Term, CMIT-ST) on dementia caregivers with elevated depressive symptoms. We will     conduct a pilot feasibility of CMIT-ST versus home relaxation practice with 24 dementia     caregivers. Half of the caregivers will be randomly assigned to receive a relaxation     recording, while the other half will receive CMIT-ST. After 4 weeks, the group assigned to     the relaxation recording will then have the opportunity to participate in CMIT-ST.      To measure the effects of CMIT-ST, we will obtain depression symptom ratings and     questionnaires about psychological symptoms before and after CMIT-ST. We will also study the     biological effects of CMIT-ST. We will do so by measuring brain activity, recording the pulse     in order to determine variation in beat to beat intervals of the heart, and studying patterns     of gene expression.   "
88928|NCT02122055|"     For the patient who passed the screen of weaning from ventilation, the traditional sedation     drug such as propofol and midazolam should be decreased or stopped, then it would induce the     stress response and agitation, such as hypertension,tachycardia etc. In order to resolve that     problem, the sedation should be given again. but if renewed to sedation, it would cause     prolonged sedation and ventilation duration.      So as to resolve above issues, after the patient passed the screen of weaning, sedation is     changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our study     to compare the efficacy and safety of sequential sedation of propofol or midazolam and     dexmedetomidine in mechanical ventilated ICU patients.   "
88929|NCT02122042|"     The aim of the current study is to evaluate, in a prospective cross-over, randomized study,     the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic impairment after low     grade glioma tumor removal surgery   "
88930|NCT02122029|"     The purpose of the current study is to determine whether an intensive lifestyle intervention     was as effective as surgery to treat morbid obesity nine years post-intervention.   "
89626|NCT02112968|"     This clinical study has been planned to evaluate the safety and effectiveness of common     treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and     Presbyopia   "
88931|NCT02122016|"     Mechanical ventilation is widely used for ICU patients as a lifesaving procedure. However, it     is associated with several complications, such as ventilator-associated pneumonia and the     increase of hospital morbidity and mortality. To avoid such complications, we need to wean     these patients off the ventilator as soon as possible. This must however be done at the right     time to avoid other complications, such as the need for re-intubation. For this reason, it is     important to have a specific weaning protocol, which will reduce the time on mechanical     ventilation, and avoiding the need for re-intubation and other complications. Recently, an     argument has developed as to which weaning protocol would be more appropriated, and whether a     computer driven weaning protocol could have better results than the conventional weaning     protocols focusing on daily screening and daily interruption of sedation followed by a     spontaneous breathing test. Our objective is to compare mechanical ventilation times, weaning     success up to 48 hours after extubation, re-intubation rates between a group with computer     driven weaning protocol (SmartCare) versus a weaning protocol with daily weaning screens and     spontaneous breathing trials in ICU patients ventilated for more than 24 hours.   "
88932|NCT02122003|"     -  Retrospective studies showed Sorafenib's efficacy as second line treatment after a          Tyrosine Kinase Inhibitor (TKI).        -  Currently there is no standard of treatment in 2nd line for patients treated in first          line with pazopanib for metastatic Renal Cell Carcinoma (mRCC).        -  With this trial we evaluate the efficacy of sorafenib as second line of treatment in          patients treated with pazopanib for mRCC.   "
88933|NCT02121990|"     The purpose of this study is to test the safety of the drug olaparib at different dose     levels. It will be given with the standard initial chemotherapy for cancer as well as a drug     called bevacizumab.   "
88934|NCT02121977|"     The aim of this study is to further evaluate the safety and efficacy of the Elevate® Anterior     and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a     controlled, post-market cohort study.   "
88983|NCT02121340|"     In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a     novel mental health/ophthalmologic intervention called, Collaborative Care for Depression     and Diabetic Retinopathy (CC-DDR), which aims to treat depression and lower HbA1C in older     African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.   "
88935|NCT02121964|"     In this prospective, randomized study, investigators will look at the outcome of total hip     arthroplasty through the anterior approach in regard to the surgical treatment of the     anterior hip capsule. At this time, there are 2 different techniques: one is excising this     capsule and the second one is cutting the capsule and repairing it at the end of the     procedure. The investigators set out to determine whether incising or repairing the capsule     will benefit the patients in terms of postoperative pain level, range of motion of the hip     joint, joint stability, surgical time and blood loss. Both preserving and excising the joint     capsule are accepted techniques in performing total hip arthroplasty. The Investigators     hypothesize that capsulectomy may allow for reduction in operative time, provide superior     surgical exposure, and increased range of motion after surgery. The influence on post     operative pain and dislocation rate is unknown.   "
88936|NCT02121951|"     Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in     which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use     of systemic analgesics and its accompanying untoward effects in those frail patients     requiring PCN that is performed in the prone position.   "
88937|NCT02121938|"     The purpose of the study is to describe the dynamics of the microbiome in the premature     infant as a means to adapt the premature infant gut to affect better health outcomes.   "
88938|NCT02121925|"     This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment     decisions of Surgeons when added to standard clinical-pathological parameters in patients     with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed     at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to     Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be     collected.   "
88939|NCT02121912|"     Participants will undergo a normal sleep study. They will be randomised to use either a FPH     Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and     pressure data, and complete questionnaires regarding satisfaction and ease of use at the end     of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard     masks for CPAP therapy in terms of ease of use, satisfaction and overall titration     experience.   "
88940|NCT02121899|"     This registry is intended to measure the effect of myPlan Lung Cancer™ test has on     influencing treatment decisions of Oncologists when added to standard clinical-pathological     parameters in patients with early stage NSCLC.      The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and     the other at Oncologists (ONC006). This registry is specific to Oncologists (ONC006).   "
88941|NCT02121886|"     To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB     surgery. Although the parietal peritoneum had already been used and published for the     reconstruction of the vena cava, however this one was never described or described in HPB     surgery   "
88942|NCT02121873|"     The objective of this study is to determine whether we can use minimally invasive techniques     to gain access to exfoliated ductal epithelial cells for whole genome sequencing.        1. To examine women with nipple aspiration, ductoscopy and ductal lavage and collect          exfoliated cells from two ducts per woman.        2. To collect a blood sample at the time of the examination in order to obtain the woman's          baseline genomic sequence.        3. De-identified samples will then have DNA and RNA extracted and whole genome sequencing          and transcriptome analysis performed by Covance and Illumina.        4. Comparisons will be made within a breast (two ducts) and between the duct and blood as          well as between women.   "
88943|NCT02121860|"     This is an open-label, parallel-group study to compare the pharmacokinetics and     pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with     mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C,     respectively) and matched healthy volunteers with normal hepatic function.   "
88944|NCT02121847|"     This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion     (Restasis®) in patients with dry eye disease.   "
88948|NCT02121795|"     This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil     fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide     (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens     containing FTC/TDF.      This study will consist of a 96 week double-blind treatment period. After Week 96, all     participants will continue on blinded study drug treatment and attend visits every 12 weeks     until treatment assignments are unblinded. All participants will return for an unblinding     visit and will be given the option to receive open-label F/TAF and attend visits every 12     weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical     development program.   "
88999|NCT02121132|"     The main objective of this study is to establish a national pediatric obesity registry known     as POWER (Pediatric Obesity Weight Evaluation Registry). This registry will contain clinical     data from individual comprehensive pediatric weight management programs around the United     States for overweight and obese youth.   "
88949|NCT02121782|"     The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC     Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in     Korean healthy adults.      The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV)     including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B).     However, two antigenically distinct lineages of influenza B (Victoria and Yamagata)     co-circulate annually in the United States. Predicting which lineage of influenza B will     predominate during a season is challenging, and cross-protection by immunization against the     other lineage is expected to be low. One proposed alternative is to produce a quadrivalent     influenza vaccine (QIV) including an influenza B virus from each of the two circulating     lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4     vaccine components WHO recommends for use in the 2013-14 influenza season (northern     hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the     additional public health benefit compared with traditional TIV.   "
88950|NCT02121769|"     Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from     fish oil. It will be used in an open label compassionate use treatment protocol, as an     alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an     effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will     evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and     PNALD.   "
88951|NCT02121756|"     The purpose of this study is to determine if Dipyridamole (DP) will decrease inflammation in     HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral     load.   "
88952|NCT02121743|"     In France around 5,000 colostomies are performed after elective or emergency surgery. These     colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of     cases.      To reduce the incidence of these outcomes, several methods have been proposed but the more     pertinent consist in the use of a biological mesh during the stoma's conception.      Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the     prevention of parastomal hernia.   "
88953|NCT02121730|"     Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD).     Between 2800 and 3000 kidney transplants are performed each year in France and more than 33     000 patients are living with a functioning graft.      Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity     decreases as the distance from the day of transplantation. Unfortunately, treatment favors     certain complications, including infectious and neoplastic. These represent a major cause of     mortality in these patients. If the frequency of skin cancer is greatly increased in this     population, that of solid tumors remains a concern. Approximately 20% of patients develop     cancer after 10 years of graft , half non- skin cancers, the main risk factor is     immunosuppressive therapy .      The aim of the study is to evaluate, in a large population of patients treated in 4 regions (     the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular     the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin     cancers and solid tumors, after renal transplantation.   "
88954|NCT02121717|"     The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with     placebo.   "
88955|NCT02121704|"     Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the     beginning of colonoscopy. MEI works by creating an electromagnetic field of very low     intensity. By that the position of the endoscope can be displayed virtually on a monitor. The     use of MEI has been shown to reduce the formation of loops and to ease the removal of     existing loops during the investigation. Furthermore, as loops favour the occurrence of pain     when the scope is moved forward, patients who underwent colonoscopy with MEI reported less     pain at the end of the procedure.      Sedation is used widely during colonoscopy for it has improved the tolerability of the     investigation. Most of the patients demand for sedation. In Germany Propofol is recommended     as the first-line sedative when endoscopy it is performed in an outpatient setting. The use     of Propofol involves the danger of respiratory complications. One reason for the application     of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if     MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We     therefore planned this prospective controlled trial.   "
88956|NCT02121691|"     The project will target two behavioral causes of obesity: a sedentary lifestyle and an     unhealthy diet. The goal is to test a faith-based intervention among men and women who are     members of participating Appalachian churches.      The primary hypothesis being tested in this project is: The change in body mass index from     baseline to one year follow-up in intervention churches will be greater than among comparison     churches, such that the differential change will be negative on average.   "
88957|NCT02121678|"     Resistance and aerobic exercise has been shown to be effective for maintenance of muscle     strength in patients with neuromuscular diseases.      Exercise in CIDP and MMN is sparsely described. The aim of the study is to evaluate changes     in muscle strength during high intensive resistance training and changes in maximal oxygen     consumption (VO2-max) during high intensive aerobic training in patients with CIDP or MMN in     maintenance therapy with subcutaneous immunoglobulin.      The hypotheses are that muscle strength and VO2-max are significantly increased during the     training sessions.   "
88958|NCT02121665|"     Periodontal disease is an infectious disease resulting in inflammation within supporting     tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies     reveal that about 10% of the adult population suffer from severe periodontitis.It comprises     of two distinct but interconnected etiologic components: the periodontopathic bacteria     adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive     responses to the causative bacteria and their metabolic products. In the arena of     periodontics, the probiotics pose a great potential of plaque modification, halitosis     management, altering anaerobic bacteria colonization, improvement of pocket depth, and     clinical attachment gain.      Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to     Scaling and Root Planing, on clinical and biochemical parameters.   "
88959|NCT02121652|"     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is     effective for insomnia in lung cancer survivors.   "
88961|NCT02121626|"     The aim of the study is to identify how often gastrointestinal problems interfere with     quality of life as a result of treatment for cancer with chemotherapy. We also want to     identify the causes for these symptoms and see if simple treatments used for other     gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for     cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently, it     can cause a whole range of physical side effects. Probably the most common side effects are     those affecting the stomach and bowels. Vomiting used to be a major problem with chemotherapy     but research discovered a whole series of new treatments so that severe vomiting from     chemotherapy is rarely a problem today. However, patients can develop a whole series of other     symptoms during chemotherapy, for example, bloating, wind, diarrhoea, needing to rush to the     lavatory and opening the bowels very frequently. The causes for these symptoms have hardly     been studied even though they sometimes affect people quite badly. In our specialist     gastrointestinal clinic at the Royal Marsden Hospital, over the last 12 years, we have     pioneered new methods for dealing with symptoms which affect the bowel after radiotherapy. We     would like to extend these methods to people having chemotherapy. We have identified several     easily treatable causes for these symptoms after radiotherapy, which previously were often     ignored. We believe that some of these causes also occur in people having chemotherapy and if     we knew how often they do occur we could focus on improving treatment for affected people. We     plan to find out how often 40 stomach and bowel symptoms occur during chemotherapy. In people     who are troubled by any or some of these symptoms we will arrange simple series tests which     could sort out why these symptoms occur and we will record how they respond to treatment.   "
88962|NCT02121613|"     The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating     subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using     Tamsulosine LP 0.4 mg as a reference treatment.   "
88963|NCT02121600|"     Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess     response to treatment in men with castration resistant prostate cancer (CRPC).      It is hypothesized that these novel biomarkers will better identify evaluable lesions prior     to therapy and identify response to treatment (or lack thereof) earlier in the treatment     period, providing a better guide for treating men with CRPC.   "
88964|NCT02121587|"     The purpose of this pre and post intervention observational study is to evaluate     patient-reported outcomes from an new clinical course which integrates Mindfulness and     Acceptance-based approaches from '3rd wave' Cognitive Behavioural Therapy with osteopathic     manual therapy treatment for patients with persistent pain.      It is being conducted by the British School of Osteopathy (BSO) in London. In Stage 1 (in     progress, June 2013 to August 2014), a course was developed for self-referring patients     attending the BSO Clinic. In Stage 2 (September 2014 to May 2016), delivery will be expanded     to evaluate outcomes for patients attending National Health Service (NHS) General     Practitioner (GP) surgeries in South East London.      The intervention consists of a pre-course screening interview; a structured course of six,     weekly, one-hour treatment sessions for individual patients; and an optional follow-up     interview after three months.      The evaluation study is being conducted by an independent study team from the National     Council for Osteopathic Research. Patients complete a set of standardised questionnaires     before the course and after six months to assess self-reported changes in quality of life,     well-being, activity levels, mindfulness and use of health resources. A sample of patients     will be invited to provide consent for a treatment session to be observed and/or recorded, or     to attend a follow-up interview after six months, to evaluate the quality of course delivery.     This is an observational study of patient-reported outcomes from a new intervention in a     single cohort of patients, so there is no formal study hypothesis but it is anticipated that     outcomes will include increased quality of life, well-being, and active engagement with     valued activities.   "
88965|NCT02121574|"     Background When a patient is anesthetised and undergoes an operation, their body temperature     falls. Managing a body temperature properly by keeping it within normal limits has been shown     to improve recovery from surgery.      A vital part of managing temperature is being able to measure it properly. There are several     ways of doing so, which consist of invasive methods such as temperature probes in the     oesophagus and bladder, and non invasive methods such as infrared scanners and ear canal     probes. During an operation, temperature changes as small as 0.5 °C can affect outcomes but,     currently, only invasive methods are reliable enough to detect this. Oesophageal probes can't     be used in patients who are not anaesthetised during their operations, and it is     inappropriate to insert a urinary catheter should it not be otherwise needed.      The purpose of this study is to look at two new methods of measuring a patient's temperature     which would help us in these situations. The first is called zero-flux thermometry and     involves placing an adhesive pad to the forehead, which gives constant measurement of a     patient's core temperature. The second involves swallowing an ingestible capsule that is no     bigger than a normal pill. This technique has been very useful in research tracking a     patient's core temperature as they are transferred through different areas over a longer     period of time. Whilst these two methods are potentially very useful, they have never been     tested on hospital patients.      Aims:      The investigators want to determine whether readings from these thermometers are accurate     enough to be used in patients before, during and after surgery. Should they prove to be     sufficiently accurate it will allow us to improve patient care through both clinical practice     and research.      Plan:      During operations, temperature is routinely measured in line with NICE guidelines with a     thermometer placed in the nose or oesophagous. The investigators will not be changing routine     practice in any way, but checking measurements from the new devices against the proven,     routine ones.      The investigators plan to record measurements from each device every minute throughout the     operation in 20 patients. The investigators will then perform statistical tests to check     their accuracy.      Study Hypothesis: Zero flux and ingestible thermometers are not significantly different at     detecting patients body temperature than oesophageal temperature probes   "
88966|NCT02121561|"     When people feel shame, they experience negative thoughts about themselves (I'm a bad     person) and urges to avoid others. Shame is related to many psychological problems, such as     depression, social anxiety, and borderline personality disorder (BPD). Because there are     currently no well-tested treatments for shame, this study will examine the utility of     Self-Acceptance Group Therapy (SAGT). SAGT is short-term group therapy that addresses shame     specifically. Changes in shame, mood, and behavior will be examined over the course of     treatment and a one-month follow-up.      Based on theory and existing evidence, Hypothesis 1a is that individuals with elevated     initial levels of shame will report improvements on all outcome measures (e.g., reductions in     trait shame, increases in self-acceptance) from pre-treatment to post-treatment, and     Hypothesis 1b is that these gains will be maintained at follow-up one month after treatment     completion.   "
88968|NCT02121535|"     The study will be performed as an open-label, randomised, single-dose, two-sequence,     four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be     randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once     or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period.     The length of admission will be 7 days in each period.   "
88971|NCT02121496|"     1. Investigators aim to assess a novel behavioral intervention (currently approved in          Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral          changes in young infants to reduce the risk of postpartum depression in a group of low          income women. More specifically, investigators aim to determine if a behavioral          intervention targeting maternal caregiving of young infants can increase infant sleep          and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of          postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve          the quality of mother-infant interaction and subsequent child development. Investigators          will study:             1. The feasibility of applying this protocol with a low SES population             2. The effectiveness of the intervention compared to usual care             3. If the effects of the intervention can be detected in assessments of the quality of               mother-infant interaction and infant neurocognitive development        2. Investigators aim to determine whether this behavioral intervention can affect infant          development as measured by neurodevelopmental assessments and cortisol reactivity at 4          months of age.   "
88972|NCT02121483|"     The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the     safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18     years with type 2 diabetes mellitus.   "
88973|NCT02121470|"     Acute Kidney Injury (AKI) is a common and severe complication in critically ill patients     which is associated with increased morbidity and mortality as well as high costs of medical     care.      NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a biomarker,     that is expressed in several tissues including the kidneys. Renal expression of NGAL is     dramatically increased in kidney injury from a variety of causes, and NGAL is released into     both urine and plasma. NGAL levels rise within two hours of the insult, making NGAL an early     and sensitive biomarker of kidney injury, with the potential to assist clinicians in managing     patients at risk of kidney injury.      This study is designed to validate the assigned NGAL cutoff value by comparing to clinical     diagnosis of AKI as determined by current clinical practice in the US.      The study sites will enroll consecutive ICU patients. Patients are given standard clinical     care and lab-work. Each day, one additional urine and two additional plasma samples will be     drawn and frozen. These additional samples are shipped to Sponsor for retrospective NGAL     measurements.      The duration of each subject´s participation will be until discharge from the ICU, or for a     maximum 8 days, whichever comes first. In addition serum creatinine values will continue to     be collected manually from the hospital data system for 48 hours after discharge from the     ICU. (If subject has been in ICU for 8 or more days, the follow up values are collected while     the patient is still in the ICU).      250 subjects will be enrolled in total at the three investigator sites. At least 40 patients     must be enrolled at each site.      The NGAL value will be matched to the clinical diagnosis of acute kidney injury (AKI) as     specified by KDIGO® guidelines. The clinical diagnosis will be assigned by a three-person     adjudication panel based on the entries in the eCRF by the investigators. Adjudicators are     blinded for investigation site, AKI-diagnosis by treating physician, and NGAL values.      A comparison of AKI diagnosis based on the cutoff value 250 ng/mL and clinical diagnosis as     assigned by the majority of the adjudication panel will be conducted.   "
88974|NCT02121457|"     Some studies reported that selenium status is associated with cognitive function. However     only a few reports have investigated whether selenium supplementation can benefit cognitive     performance and in most of them selenium supplementation was not exclusive. Also, none of     those reports have used foods rich in selenium as a source of supplementation. Thus, the aim     of our study was to investigate whether the consumption of Brazil nuts improves cognitive     function. We hypothesized that the daily consumption of Brazil nuts would have benefits on     selenium status, increase antioxidant enzyme activity and improve cognitive function in older     adults with MCI.   "
88975|NCT02121444|"     This study aims to investigate adherence to therapy among patients treated with Betaferon who     are using the BETACONNECT autoinjector.   "
88976|NCT02121431|"     This trial addresses a serious and all-too-frequent public health problem, namely early-onset     disruptive behavior problems in young children. The focus is on testing an online treatment     program which empowers parents to help their children to improve their mental health and     behavioral functioning. At the conclusion of the study, the investigators will know whether     the online-delivered program works as well as an established staff-delivered program, with     respect to child disruptive behavior problems, parenting, parent/family stress, consumer     satisfaction, and value analysis.   "
88977|NCT02121418|"     This clinical trial studies decitabine and cytarabine in treating older patients with newly     diagnosed acute myeloid leukemia, myelodysplastic syndrome that is likely to come back or     spread to other places in the body, or myeloproliferative neoplasm. Drugs used in     chemotherapy, such as decitabine and cytarabine, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Giving     decitabine and cytarabine may work better than standard therapies in treating cancers of the     bone marrow and blood cells, such as acute myeloid leukemia, myelodysplastic syndrome, or     myeloproliferative neoplasm.   "
88978|NCT02121405|"     The purpose of this study is to determine whether primary radiotherapy can be omitted for the     locally advanced rectal cancer with Magnetic Resonance Imaging (MRI) negative circumferential     margin.   "
88979|NCT02121392|"     The purpose of this study is to further investigate the efficacy of adductor canal nerve     blocks for pain management after total knee replacement. Specifically we are studying     adductor canal nerve blocks in conjunction with epidural anesthesia, which is a combination     that has not been extensively researched before. Our question is whether combining these     modalities will enhance patient satisfaction after surgery and accelerate patients' readiness     to discharge.   "
88980|NCT02121379|"     Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who     undergo cytotoxic chemotherapy.      We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.   "
88981|NCT02121366|"     The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol     ablation of an insulinoma.   "
89307|NCT02117115|"     Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell     transplant, and radiographic evidence of mucosal inflammation will be correlated with the     subsequent development of acute graft versus host disease. The primary endpoint is the     feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period,     as defined by the risk of contrast-related nephropathy or allergic reaction.   "
88982|NCT02121353|"     The aim of this study is to test if PF582 (ranibizumab) is safe and similar to Lucentis     (ranibizumab). Participants will have a screening visit to check for eligibility. Eligible     participants will receive either PF582 or Lucentis, by injection into one eye on study Day 1,     28 and 56. Visits will be conducted on Day 2, 7, 14 80 and at 6 and 12 months. During the     study participants will undergo the following procedures: height, weight and vital signs     (blood pressure, pulse, temperature, breathing rate) measurement; medical and surgical     history and concomitant medications; adverse event monitoring; physical examinations; eye     tests (reading chart, measurement of retinal thickness [via pictures of the retina] and     examination of the eye's blood vessels, via pictures taken following injection of a dye into     the arm), blood collection and a urine pregnancy test, where applicable.   "
88985|NCT02121314|"     WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug     concentrations are too low; on the other hand: if this is not tolerated, drugs could also be     taken with food.      Do lower drug concentrations - with improved adherence to therapy - outweigh the disadvantage     of lower drug blood concentrations over time? How exactly do the drug concentrations over     time (pharmacokinetics) compare between fasting and fed conditions, especially in the early     stage of TB treatment when patients are relatively sick, and relatively poorly tolerate TB     drugs?   "
88986|NCT02121301|"     The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and     effective compared to placebo for the treatment of the signs and symptoms of dry eye     syndrome.   "
88987|NCT02121288|"     The purpose of the study is to assess the effect of blood flow to the heart when subjects are     treated with ticagrelor (Brilinta) or clopidogrel (antiplatelet drugs that stop the blood     from clumping together) in patients with Peripheral Artery Disease (PAD).   "
88988|NCT02121275|"     Atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients who     are anaesthetized and intubated. The goal of the present prospective study is to detect     atelectatic areas in the perioperative period in the lungs of patients undergoing elective     laparoscopic surgery non-invasively and without x-ray exposure. Results of lung ultrasound     (LUS) as the experimental method will be compared to the results of Electrical Impedance     Tomography (EIT) as the reference technique for the detection of atelectasis. A device for     peripheral Oxygen saturation measurement (MASIMO Radical-8) will detect changes in     ventilation. The investigators want to confirm or disprove former findings of the appearance     of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of     atelectases.   "
88989|NCT02121262|"     This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser     photocoagulation in patients with diabetic macular edema (DME).   "
88990|NCT02121249|"     The purpose of this study was to quantify potential short- and long-term benefits of     robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar     or lumbosacral spine disease in adult patients, in comparison to instrumentation in a     matching cohort of control patients performed using conventional freehand technique.   "
88991|NCT02121236|"     This is an in vivo study which aims to evaluate the diagnostic accuracy of ultrasonography in     detecting benign radiolucent lesion in the both jaws. The ultrasonography-based diagnosis of     contents will be compared to those findings obtained from the histological examination (i.e.     the gold standard). The second part of this study will examine the measuring accuracy by     comparing ultrasonography-based 3D measurements with those obtained from CBCT images of the     lesion assuming that CBCT 3D measurements are the gold standard.   "
88992|NCT02121223|"     To evaluate the effective and safety of post-dilatation in patients with acute ST segment     elevated myocardial infarction undergoing primary percutaneous intervention after thrombus     aspiration assessed by optical coherence tomography to examine stent Incomplete apposition     and strut coverage in patients treated with drug-eluting stents .   "
88993|NCT02121210|"     Primary Objective:      To evaluate the immunogenicity of sarilumab administered as monotherapy.      Secondary Objectives:        -  To evaluate the other safety aspects of sarilumab administered as monotherapy.        -  To assess the exposure of sarilumab administered as monotherapy.   "
88994|NCT02121197|"     To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in     clinical practice management of patients with DME.   "
88995|NCT02121184|"     Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal     status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by     approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables     which could affect fetal heart rate patterns at the time of initiation of analgesia, such as     fluid administration and oxytocin management, could help us provide better care for our     patients and their fetuses.      Hypotheses: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin     administration will have fewer non-reassuring fetal heart rate (FHR) changes.   "
88996|NCT02121171|"     The objective of this prospective randomised study is to compare the efficacy and safety of     ologen CM (Collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital     glaucoma cases, the efficacy being the primary objective and the safety being the secondary.     The investigators hypothesize that combined trabeculotomy-trabecuectomy with Ologen collagen     matrix implant implantation in congenital glaucoma is a safer procedure and may yield better     results than combined trabeculotomy-trabeculectomy approach.   "
88997|NCT02121158|"     The overall aim of this trial is to study the safety and efficacy of ICD implantation as a     primary prevention strategy of sudden cardiac death in patients 70 years and older. This     study will assess the many competing factors involved with ICD implantation including 1) the     impact on mortality, especially in the context of a declining rate of sudden death with     advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3)     the impact on quality of life.   "
88998|NCT02121145|"     In a recent controlled study, the investigators explored cross-reactive immune responses     against different Salmonella spp. in healthy volunteers immunized with either the oral     (Vivotif® ) or parenteral (Typherix®) typhoid vaccines (ISRCTN68125331). In the present study     immune responses will be studied in a group receiving both of these vaccines and in the     previously immunized volunteers after booster immunization (same groups receive same vaccines     2-4 years after primary immunization).   "
89000|NCT02121119|"     In practice ambulatory orthopedic surgery, one of the problems of most difficult solution is     adequate control of postoperative analgesia. Pain is a frequent cause of consultation and     unscheduled readmissions in this group of patients.      The use of continuous peripheral nerve blocks are an effective tool in postoperative     analgesia.      In this connection, most of the studies of continuous infusions of local anesthetics by     perineural catheters have been made with bupivacaine, levobupivacaine, and ropivacaine     However, it has been found that lidocaine action lasts less, has lower cost and is less toxic     than longer-acting agents.      The investigators aim is to compare the effectiveness of lidocaine versus bupivacaine     continuous popliteal sciatic blockade ambulatory elastomeric pump.   "
89001|NCT02121106|"     With medication, many individuals with psychosis experience a remission from hallucinations     and delusions, the most salient aspects of the disorders. However, alleviation of these     symptoms is not associated with recovery of everyday functioning in important areas like     working, socializing, maintaining the household, and recreational pursuits. The reason these     difficulties with functioning persist is that psychotic disorders are associated with     considerable difficulties with cognitive functions such as attention, memory, and planning.     Cognitive impairments persist even when the delusions and hallucinations are treated, and in     fact account for most of the persistent impairments in functioning.      Recently, psychological treatments called Cognitive Remediation have been developed and     tested in research settings, where techniques that train the brain to process information     more efficiently result in very large improvements in cognition. However, there are two major     hurdles remaining as investigators attempt to determine how this treatment can graduate from     research laboratories to become a widespread clinical treatment. First, cognitive remediation     in research settings is very intensive: it requires frequent visits with specialized     therapists who deliver the treatment to groups of patients. This makes it quite difficult for     people with psychosis, who might not have the financial means or motivation to travel and who     might be experiencing symptoms that make it unlikely that they will attend groups, to     participate fully if the traditional research techniques were directly transported to a     clinical setting. The second hurdle is that even though cognitive remediation improves     cognition, it does not always transfer to everyday behavior changes. Investigators recently     found that this transfer to functioning is more meaningful and durable when using additional     techniques that teach people skills such as being aware of your own thinking and to use     multiple, flexible problem solving strategies.      The goal of this project is to address these limitations by testing a new development in the     treatment: delivering cognitive remediation to participants in their homes, with cognitive     exercises and therapist support provided online. The techniques are the same as successful     in-session cognitive remediation, but those with psychosis can engage in the intervention at     home and therapists will be able to service more individuals with online discussion forums     and video demonstrations. The more people engage in cognitive remediation, the better the     outcomes. This is particularly true for receiving a consistent dose of exercise, rather than     in longer, once per week sessions typical of traditional psychotherapies. The online     component of this program provides patients with the ability to engage in a higher and more     consistent rate of exercises and skill development, and we will explore whether the amount     and continuity of engagement is associated with larger and broader improvements.   "
89002|NCT02121093|"     The vibration stimulation is regarded as a new method of training and therapy to change     afferent parts and cortical projections, which are important for motor control. This study     aims to check effects of different frequency parameters for electrical cortical potentials     and electrical muscular potentials in healthy young adults. 80 volunteers will participate in     the study, and they will be randomly subdivided in four groups for trials. The methodology     consists of electroencephalographic and electromyographic assessment before and after     15-minute vibration application with a digital vibratory pad.   "
89003|NCT02121080|"     This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety,     tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in     cohorts of healthy adult volunteers.   "
89004|NCT02121067|"     This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for     contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides     contraception for 5 years with excellent effectiveness. Women enrolled in this study will     only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants     will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for     satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months     postpartum, and participants will be able to keep their LNG-IUS following study completion.   "
89005|NCT02121054|"     The purpose of this study is to evaluate the prognosis of patients with resistance to     antiplatelet agent and develop tailored treatment model for patients with coronary artery     disease.   "
89006|NCT02121041|"     The purpose of this study is to compare the effectiveness of ambulatory blood pressure     monitoring to usual care (blood pressure measurement in the office) in diagnosing and     managing hypertension.   "
89007|NCT02121028|"     The objective of this study is to determine the mechanisms of stroke in patients with     Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of     antegrade flow through the stenotic artery, distal tissue perfusion to the affected     territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging     biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective     multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients     will be studied within 21 days of the index event (allowing appropriate time to arrange for     diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate     mechanisms of recurrent ischemia:        -  Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through          the stenotic artery.        -  Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue          perfusion.        -  Vasomotor reactivity by Transcranial Doppler using the breath-holding technique          (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the          affected artery;        -  Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery          embolism that reflects plaque instability.      Patients will receive standardized medical management and its effectiveness on blood     pressure, lipid, and glycemic control will be monitored.      The primary outcome is recurrent stroke in the territory of the stenotic artery during a     1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI     in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack     (TIA) in the distribution of the stenotic artery during a 1-year follow-up period.      Patients will be recruited at various sites that will be trained and certified on the imaging     techniques employed. Raw imaging data will be interpreted centrally.   "
89008|NCT02121015|"     The overarching aim of this project is to develop and pilot an innovative online intervention     (Share) that integrates an Individual Internet Intervention (III) and an Internet Support     Group (ISG) in preventing Postpartum Major Depression (PPMD). To establish that supportive     accountability is a critical component of the intervention, Share will be compared to an III     alone, and an ISG without the III components.   "
89009|NCT02121002|"     To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical     Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.   "
89010|NCT02120989|"     We will undertake initial development of a new behavioral sleep intervention (i.e.,     partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold     standard treatment, CBT-I. We will examine if the new treatment has a positive impact on     subjective and objective sleep and quality of life in a clinic-based sample. Secondary aims     will examine treatment adherence and maintenance of therapeutic gains as well as relationship     satisfaction and broader psychiatric functioning.   "
89627|NCT02112955|"     The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing     stroke self-management program on recovery of community-dwelling stroke survivors.   "
89016|NCT02120911|"     Despite neoadjuvant chemoradiation regimens esophageal cancer remains a disease with poor     outcome. The clinical benefit of HER2 targeting with trastuzumab has been shown in the     setting of advanced disease and disease and safety of combining trastuzumab with     chemoradiation in the curative setting has been established. In breast cancer, the added     value of pertuzumab to standard treatment with trastuzumab has been shown both in the     neoadjuvant and the metastastic setting. Taken together, there is a sound rationale to     explore the combination of radiotherapy plus chemotherapy with trastuzumab and pertuzumab in     HER2+resectable esophageal cancer. However, since the number of HER2+ patients in this     setting is limited, and no data are available on the safety of this combination prior to     major surgery, we propose to first conduct a feasibility study with this treatment stratgy.     When the results of this study show that this treatment strategy is feasible, we will     subsequently design a prospective study with efficacy as primary endpoint.   "
89017|NCT02120898|"     The purpose of this study it so compare the safety and efficacy profiles of a generic     imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of     actinic keratosis.   "
89018|NCT02120885|"     Gastric cancer is a major health issue and one of the most common malignance in Korea. With     the popularization of cancer screenings and increasing the average lifespan, the number of     gastric cancer patients is increased. In the past, most of the research were concerned with     survival and recovery after cancer surgery. However, as the medical technology had been     developed and recovery rate and survival rate of cancer patients had risen, the patients     wanted to return to a daily life and desire for participation for leisure. In other words,     the patients who underwent surgery wants to maintain a high quality of life(QOL) level as     like prior to cancer surgery.   "
89019|NCT02120872|"     The purpose of the present study was to investigate the efficacy of autologous Platelet rich     fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment     of three wall intrabony defects in comparison to OFD alone.   "
89020|NCT02120859|"     We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided     use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal     stenting for elective PCI of de novo coronary lesions.   "
89021|NCT02120846|"     Forty patients will be assigned to either a training group (12 wk unilateral knee extension     flywheel resistance exercise; 4 sets of 7 reps 2 days/week) or a control group. Patients will     maintain daily routines and any prescribed rehabilitation program. Established methods to     assess muscle and cognitive function will be employed before and after the intervention.      This project will disclose whether an exercise paradigm, known to improve muscle function and     increase muscle volume in healthy populations, will induce similar adaptations in chronic     stroke patients. More importantly, this study will elucidate if any impairment in cognitive     function caused by stroke, can be reversed with this particular resistance exercise regimen.      The information gained from this project will have significant implications and aid in     advancing rehabilitation programs and exercise prescriptions for men and women suffering from     stroke. The overall objective of this research is to promote independence and hence quality     of life in these patients.   "
89022|NCT02120833|"     This study is for infants with mild to moderate dry and itchy skin. This study will involve     going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a     dermatologist to determine if they have atopic dermatitis and have an active mild to moderate     eczema wound. Participant's parents/guardians will be asked a few questions to determine if     their child qualifies for the study.      Then all participants' caregivers will complete a questionnaire at the beginning of the     study. The child's skin will be examined to rate the level of their eczema and a trained     examiner will grade the looks and symptoms of their eczema. All parents or guardians will be     instructed how to apply the test product and how to record usage on a diary card and then     apply the test product. The test product will be applied at least 2 times per day or more as     needed on all body areas, including the face affected throughout the study.      One digital picture will be taken of one eczema wound. Another digital picture will be taken     of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and     Day 14.      Once product is applied the skin will be examined for any adverse events and all     participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.   "
89023|NCT02120820|"     The aim of this study is to evaluate the effectiveness of multisensory environment (MSE)     and/or massage therapy (MT) in residents with severe and profound intellectual disabilities     (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual     care environment, or usual care with attention.      Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and     MSE on relaxation and reducing challenging behaviours, the following null hypotheses are     suggested:        1. There will not be any differences on reducing heart and respiration rates between          MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week          follow-up.        2. There will not be any differences on adaptive behaviours and levels of alertness between          MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week          follow-up.        3. There will not be any differences on frequency and severity of challenging behaviours          between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a          2-week follow-up.   "
89024|NCT02120807|"     The purpose of this study is to test the safety of certolizumab when it is given with the     chemotherapy drugs cisplatin and pemetrexed. Cisplatin and pemetrexed are two chemotherapy     drugs used in the treatment of lung cancer. The investigators want to find out what effects,     good and/or bad, certolizumab has on the patient and lung cancer.   "
89025|NCT02120794|"     The study objective is to demonstrate that home use of Threshold Suspend (TS) is not     associated with glycemic deterioration in pediatric patients with type 1 diabetes, as     measured by change in A1C.   "
89026|NCT02120781|"     The objectives of this study are to assess the safety of azficel-T treatment for dysphonia     related to vocal fold function and to evaluate the efficacy of azficel-T for the treatment of     dysphonia related to vocal fold function.   "
89497|NCT02114827|"     Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic     stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT     frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at     the National Institutes of Health (NIH).   "
89027|NCT02120768|"     The randomized, controlled trial is aiming at comparing local control rate between two     surgical resections, barrier resection and local wide resection with 1cm or equivalent normal     tissues. This is based on the fact that the goal of local surgical treatment is to remove the     tumor with negative margin and best functional outcome, but there is a lack of standard     principle of surgery. Some surgical oncologists recommended enlarging surgical field in which     case the associated muscle was removed from origin to insertion, the previous surgical scar     and radiation field were also grossly remove, though there would be extra trauma and     unacceptable function impairment, they believe that patients would benefit from big     operations. Most other surgeons would perform a sarcoma resection through normal tissues,     and reported a fair local control as long as a negative margin was obtained. As reported by     various authors, recurrent STSs are associated with higher risk to develop further recurrence     as compared to primary STSs, thus, efforts should focus on this category of STSs to improve     outcome.   "
89028|NCT02120755|"     This research project is testing a product called AmnioClear™ which is an amniotic membrane     graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human     amniotic membrane is regulated solely under section 361 of the Public Health Service Act.      The purpose of the study is to see if this treatment works to accelerate the healing time of     chronic wounds.   "
89029|NCT02120742|"     This study seeks to evaluate the impact of a text-message (SMS) program delivered to     motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit Amend,     sends daily reminders to motorcycle drivers to remind them to wear their helmets. In this     study, the investigators will conduct a randomized controlled trial to see if this program     leads to increased helmet use over time. The investigators will recruit between 350-400     motorcycle drivers to receive the text program. The investigators will obtain each of their     cell phone numbers, and the participants will be split into three groups. The first group     will receive reminders framed as social norming (ie Most of your peers wear helmets). The     second group will receive reminders framed as fear appeals (ie Not wearing your helmet     increases your chance of dying in an accident). The third group will act as the control and     receive texts that relate to general road safety, but not helmet use. All groups will receive     the same general road safety information being delivered to the control arm. The purpose of     sending different types of reminders is to assess which type of messages are more likely to     cause a motorcycle driver to regularly wear their helmet. The investigators will survey the     participants at the initiation of the study and after weeks 3 and 6 during the study, asking     about their helmet use. This will be a short survey, and any personal information gathered     during the study (ie, phone numbers), will be securely stored so as to protect their privacy.   "
89030|NCT02120729|"     This Randomized Clinical Trial (RCT) compares outcomes in 1500 patients with major depressive     disorder (MDD) treated according to the patient's CYP2D6 genotype status (N=1000) versus     empiric standard-of-care psychotropic therapy (N=500). The hypothesis is that provision of     medication based on the functional status of the patient's CYP2D6 enzyme inferred from     genotype results within 48 hours of admission to treating clinicians will, through refined     selection of psychotropic medication during hospitalization, decrease length of psychiatric     hospitalization stay and decrease the rate of 30 day re-admission.      The trial setting is the Hartford Hospital Institute of Living (IOL). The IOL operates the     Clinical Evaluation and Monitoring System (CEMS), an innovative electronic messaging system     developed by Co-Investigator Dr. J.W. Goethe. The Hartford Hospital Genetics Research Center     (GRC) performs the genotype testing. CYP2D6 genotype analysis detects all known polymorphisms     that result in an enzyme with sub-normal or supra-normal function. In this study, CEMS     transmits clinically actionable guidance based on the patient's genotype to the clinician,     advancing the medication alerts in real time.      The RCT will test the effects of timely incorporation of medication recommendations based on     CYP2D6 genotype into CEMS. The RCT assigns 500 patients to standard therapy (Group S) for     whom CYP2D6 genetic information is determined but not transmitted to the treating clinician,     allowing psychotropic therapy to be empirically determined, and 1000 to genetically guided     therapy (Group G) where genotyping result and treatment recommendations are furnished via     CEMS to the clinician within 24 hours of DNA sampling and 48 hours of admission. For patients     in Group G who are poor or rapid metabolizers, medications primarily metabolized by the     CYP2D6 enzyme are proscribed.      The primary outcome is hospital length of stay and the secondary outcome, the frequency of 30     day hospital readmission. Additional genetic stratification of both Group S and Group G will     allow investigation of specific psychotropic usage.      The expected benefits are 1) quantitative understanding of the effect of providing CYP2D6     pharmacogenetic information on length of hospitalization, 30 day readmission rate, and     associated costs; and 2) objective benchmarking for the comparative effectiveness of CYP2D6     genotyping for guiding psychotropic therapy.   "
89031|NCT02120716|"     The objective of this study is to develop and determine feasibility of a computer-delivered     intervention (Health Check-up for Expectant Moms) approach to target women at risk for     HIV/STIs and alcohol/drug use during pregnancy through two phases of testing:      The development aims of this study are to:        1. Develop intervention content.        2. Perform a small open trial (n = 10) of the computer based intervention (Health Check-up          for Expectant Moms) to assess feasibility of recruitment of target population and          acceptability of the intervention and study procedures via participant report of ease of          use, helpfulness, and overall satisfaction.      The pilot study aims of this study are to:        1. Conduct a randomized controlled pilot study in a sample of 50 high risk (at risk for          HIV/STIs and alcohol/drug use) pregnant women.        2. Determine:             1. feasibility of the computer based intervention             2. acceptability via participant report of ease of use, helpfulness, and overall               satisfaction             3. evidence for the hypothesized effects on outcomes: the proposed intervention, in               comparison to a time-and-attention-matched control group, will produce reductions               in HIV/STIs risk behavior during the follow-up assessment at 4 months.        3. Determine if the intervention condition, relative to control, will produce reductions in          alcohol/drug use (frequency, quantity, and heavy drinking/use frequency).        4. Determine effects on process variables: if participants assigned to the intervention          condition, relative to control, will demonstrate greater increases in knowledge,          readiness to change and risk perceptions.   "
89032|NCT02120703|"     Pregabalin is claimed to have superior analgesic effect at lower doses and better     pharmacological profile as compared to gabapentin esp. in perioperative pain control after     major surgeries like intervertebral disc surgery.      The investigators found that pregabalin is equivalent to gabapentin for relief of     post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.   "
89033|NCT02120690|"     To the investigators knowledge there are no studies of Trigeminal Nerve Stimulation (TNS) for     fibromyalgia. TNS may modify overlapping mood and fibromyalgia pain regulation circuitry. The     investigators hypothesized that patients with fibromyalgia might experience a clinically     significant reduction in daily pain if investigators were to administer TNS in a manner     similar to experimental antidepressant protocols.   "
89034|NCT02120677|"     This research is being done to study the molecular effects of topically applied itraconazole     ointment on the growth of basal cell carcinomas.   "
89036|NCT02120651|"     The diagnosis of tympanic perforation reaches a high number of records in otorhinolaryngology     services worldwide. Most of the tympanoplasties are performed in patients whose cause of     perforation and hearing loss was chronic otitis media; this entity affects the population     between 0.5 to 30% , the statistics mention more than 20 million people with this disease in     the world. Since the introduction of tympanoplasty in the second half of the nineteenth     century there have been numerous publications nationally and internationally about various     experiences and new techniques. Including the use of fibrin monomer . This procedure is     usually performed with the use of hemostatic sponge and recently with fibrin monomer, both     materials are part of the basic input and surgical hemostatic agents. In this hospital are     performed on average 110 tympanoplasty per year which has a percentage of non- integrity of     the graft in the case of microscopic tympanoplasties using hemostatic sponge of 16% which is     similar to the index of lack of integrity of the graft in microscopic tympanoplasties     reported worldwide (18%), with the recent addition to the service of fibrin monomer, was     necessary to evaluate if this material contributes to the integrity of the graft in     microscopic tympanoplasty, as it has been reported in previous studies, so if there is found     more integrity with this material, it can be recommended for routine use, improving the final     prognosis of the patients.   "
89037|NCT02120638|"     Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge     to TB control program. That pyrazinamide can shorten the course of treatment and facilitate     bacilli clearance has been proved recently. In 2011, WHO recommended to use pyrazinamide     throughout the course of treatment for MDR-TB. However, pyrazinamide susceptibility testing     has not been widely used in clinic. And the conventional testing is time-consuming and     unreliable. In contrast, the detection of pncA and rpsA mutations with molecular methods can     provide rapid results of pyrazinamide susceptibility. The purpose of this study is to     evaluate the efficacy of the introduce the molecular testing of pyrazinamide susceptibility     in optimizing the MDR-TB treatment regimen.   "
89038|NCT02120625|"     The purpose of this study is to document the effectiveness of the Nimbus Multi-tined     Expandable Electrode (MEE) Probe in carrying out the heating and ablation (cutting) of the     small medial branch nerves that carry pain information from the facet joints. Subjects will     be selected, by way of clinical evaluation and response to medial branch blocks, to undergo     this procedure of radiofrequency ablation/neurotomies of the medial branches to the specific     painful facet joints of the low back in order to relieve pain. This will be carried out with     an FDA-approved device using a standard technique that has been accepted throughout the     world. The difference in this study is that we will make use of MRIs to image the lesion that     is produced and a special EMG study to look at the muscles in the back to document the     effectiveness of the device in creating the intended lesion. No other study of this kind has     been produced to look at this or any other radiofrequency device in the treatment of low back     pain.   "
89039|NCT02120612|"     The purpose of this study is to determine the effect that an educational intervention has on     patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a     suburban outpatient treatment program.   "
89040|NCT02120599|"     Malnutrition during pregnancy is more common in poor women in the developing world due to     inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is     more consequential than among other demographic groups with increased risk of maternal and     infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating     moderate malnutrition during pregnancy remain largely undocumented. This study tests the     hypothesis that providing either a fortified flour or fortified paste-based supplementary     food designed to replete the nutrient deficits during pregnancy will result in improved     maternal nutritional recovery rates and higher infant birth weights and lengths. This study     is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately     malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations: 1)     a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily     allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a     multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients     (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and     folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the     supplementary food until they recover from MAM. The outcome of the pregnancy and maternal     nutritional status will be followed until 3 months after delivery.   "
89041|NCT02120586|"     This study evaluates two strength training protocols (one in peripheral muscles and one in     inspiratory muscles) in the improvement of skeletal muscle mass and function in     institutionalized elderly with sarcopenia. Participants will be assigned randomly in a     control or one of both experimental groups.   "
89042|NCT02120573|"     This prospective study evaluate teaching efficacy of CPR training using different methods in     general population, medical students and non medical students with the 12 months evaluation     of its recall   "
89057|NCT02120378|"     Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or     live birth, there seemed to be a need for a study that ends up with reaching a definition for     the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight     more than 500 grams, while in Egypt, this is not applicable. basically the neonate has a     chance of survival if the weight is more than 1000 grams or of gestational age more than 26     weeks.   "
89058|NCT02120365|"     The purpose of this study is to determine whether perampanel alters the response to alcohol     for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and     reinforcing properties of alcohol in the laboratory setting.   "
89131|NCT02119416|"     Caffeine use is on the rise in America, and one of the most popular sources is soda. Among     youth ages 8-16, caffeine consumption has increased by over 70% in the past 30 years. Few     studies have examined the role of hormones in caffeine consumption within this age group.      The purpose of the current experiment was to determine the effect of caffeine on children 8     and 9 compared to those 15 and 16 years of age. The investigators were looking at the effect     of puberty on the consumption of caffeine as well as the effect that the caffeine has on the     body (for example: heart rate, blood pressure) and cognitive function.   "
89132|NCT02119403|"     To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of     up to 72% nitrous oxide and ambient air.   "
89043|NCT02120560|"     Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States, and     treatment by AF ablation is quickly becoming the favored definitive therapy. Nonetheless, AF     ablation comes with some risk, including bleeds related to vascular access and myocardial     damage, as well as the rare incidence of clinical stroke from blood clots that travel from     the heart to the brain, termed cerebrothromboemboli. In fact, cerebrothromboemboli without     any symptoms have been detected by special imaging procedures called brain magnetic resonance     imaging (MRI) in as many as 22% of cases.(1-6) There remains clinical equipoise amongst     experts regarding balancing the risks and benefits of continued versus interrupted blood     thinning, or anticoagulation during AF ablation as they pertain to risk of bleed and     cerebrothromboemboli prevention, respectively, and the potentially more subtle sequelae of     these apparently silent cerebrothromboemboli remain unknown. In fact, both interruption and     continuation of anticoagulation during AF ablation are the standard of care. The     investigators will perform the first randomized trial of uninterrupted versus interrupted     anticoagulation in patients undergoing AF ablation to determine if it mitigates neurologic     injury. The objective of this research is to investigate the effect of continued     anticoagulation for AF ablation on cerebrothromboemboli, and the neurocognitive sequelae of     embolic lesions, which to this point are considered subclinical. The investigators     hypothesize that continued anticoagulation will both reduce cerebrothromboemboli and mitigate     any potential decline in neurocognitive function post-procedurally. The investigators also     hypothesize that the incidence of cerebrothromboemboli (CTE) by MRI will mediate that     difference.   "
89044|NCT02120547|"     To determine whether CVC exposures are altered in subjects with impaired hepatic function,     compared to subjects with normal hepatic function. The results will help guide the clinical     use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any,     and identify the potential need for dose adjustments of CVC in this population.   "
89045|NCT02120534|"     The present study will be conducted to determine the dynamic changes of serum soluble CD14     and the corresponding changes of serum CD88 and their correlation in critically ill sepsis     and SIRS patients.   "
89046|NCT02120521|"     A total of 120 patients will be included in the study. Sixty patients are critically ill with     evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill     without evidence of infectious organism (SIRS group). At admission, Patients data include     clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood     gas analysis are measured. Routine cultures will be obtained. The attending physician will     evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in     ICU. A serum level of sTREM-1 and MNDA will be monitored.   "
89047|NCT02120508|"     The substantial efficacy and the possible mechanism of repetitive transcranial magnetic     stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the     rTMS was associated with increased synaptic connection and neural regeneration which can be     evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS     intervention was monitored by clinical testing and neuroimaging study.   "
89048|NCT02120495|"     This study will apply the digital techniques to do the condylectomy through an intraoral     approach without needing to do the intraoral vertical ramus osteotomy (IVRO). This new     surgical technique will greatly maintain the TMJ anatomy structure, reduce the risk and     increase the precision of the operation procedure.   "
89049|NCT02120482|"     Recipient desensitization is a prerequisite for successful ABO-incompatible kidney     transplantation (ABOi-KTX). Published desensitization protocols commonly include the use of     plasmapheresis or selective (i.e. antigen-specific) immunoadsorption (IA), together with     distinct immunomodulatory measures (e.g. CD20 antibody rituximab). Selective IA represents an     efficient but cost-intensive therapy. An alternative could be the use of semi-selective     (non-antigen-specific) IA. Even though highly efficient in depleting ABO-specific IgG,     semi-selective IA may only marginally affect levels of ABO-specific IgM, which might - due to     the strong complement activating potential of this Ig class - exhibit a potential risk for     (hyper)acute antibody-mediated rejection (Wahrmann et al. 2012, Nephrol Dial Transplant). In     a randomized crossover trial (Eskandary et al. 2014, Nephrol Dial Transplant;     www.clinicaltrials.gov, NCT01698736) we have recently shown that the combination of     semi-selective IA together with membrane filtration, a technique primarily used in the field     of LDL apheresis, can yield excellent elimination of both IgM and IgG reactivities, as well     as essential macromolecules such as the classical complement key component C1q. In this     two-center phase 2 pilot study (N=10) we plan to evaluate the safety and efficacy of this     alternative desensitization strategy in ABOi-KTX.   "
89050|NCT02120469|"     This phase I/IB trial studies the side effects and best dose of eribulin mesylate and     everolimus in treating patients with breast cancer that does not have estrogen receptors,     progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein     (triple-negative) and has spread to other places in the body (metastatic). Eribulin mesylate     and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
89051|NCT02120456|"     Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily     treatment for two consecutive days      Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two     consecutive days compared to vehicle   "
89052|NCT02120443|"     A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch     Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy     sites.   "
89053|NCT02120430|"     There is an increasing need for parenting programs aimed at promoting parent-child     interaction. A variety of interventions have been proposed. The use of audiovisual materials     for parents has been shown to be effective but limited information is available on the     optimal timing for its use, particularly for new parents during the first year of life of     their children.      Based on the hypothesis that the effectiveness of information provided to first-time parents     in modifying their knowledge, attitudes and intentions regarding rearing practices may depend     on when the information is delivered, we designed an open randomized controlled trial to     compare the effectiveness of administering a video at two different times, i.e. at one and     seven months of age of the child.      The video addressed four specific activities related to early child development: reading     aloud to the baby, early exposure to music, promotion of early socialization for parents and     for children.   "
89059|NCT02120352|"     This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having     an overall objective to evaluate the antiviral activity, tolerability, and safety of two     intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30     milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1     infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744     (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278     LA is the long acting injectable formulation of TMC278.      The study will consist of three parts: an Induction Period, Maintenance Period and Extension     Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study     and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period,     eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and     600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects     will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA     600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg     every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of     GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the     Extension Period). The Extension Period will allow for a collection of longer term efficacy     and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.      The study will involve sufficient subjects at screening in order to ensure a total of     approximately 265 subjects at the beginning of the Induction Period and approximately 225     subjects randomized into the Maintenance Period.   "
89060|NCT02120339|"     Estimate the effect of chronic beta-adrenergic receptor blockade with carvedilol on RV     function in patients with PAH.      Assess the safety and tolerability of chronic carvedilol therapy in patients with PAH   "
89061|NCT02120326|"     The purpose of this study is to determine whether TDCS is an effective prophylactic therapy     of chronic migraine.   "
89062|NCT02120313|"     The purpose of this study is to compare the effectiveness of inpatient and outpatient     rehabilitation following total knee arthroplasty. No studies exist that have evaluated these     two rehabilitation programmes in a specific orthopaedic patient population with a focus on     motor performance. We hypothesized that patients participating in outpatient care tend to be     physically more active than patients in the rehabilitation clinic, leading to the assumption     that outpatient rehabilitation has superior functional outcomes compared to the inpatient     standard-of-care therapy.   "
89063|NCT02120300|"     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and     tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)     in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF)     plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with     an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV     coinfected) will be enrolled.   "
89064|NCT02120287|"     This is a phase II study on the usage of stereotactic Gamma Knife radiosurgery as a boost to     the tumor bed border zone in conjunction with the usage of bevacizumab.   "
89065|NCT02120274|"     The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins     D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of     genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.   "
89066|NCT02120261|"     This study is a prospective, randomized, double-blinded trial involving adult patients     diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to     compare if there is a therapeutic difference between trigger point injections of normal     saline and conventional drug mix (local anesthesic + steroid) in treating MPS. In particular,     we will find out about the pain level and duration before and after injection.   "
89067|NCT02120248|"     The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become     a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC).     As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered     peer counseling. Little is known as to the effectiveness of these peer counseling programs.     Randomized controlled trials of peer counseling interventions among low-income women in the     U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the     level of support provided could be scaled up to service WIC clients nationally. The     investigators tested whether a telephone peer counseling program among WIC participants could     increase breastfeeding initiation, duration and exclusivity.   "
89068|NCT02120235|"     Although lysosomal storage disorders, such as Fabry disease, Gaucher disease, and Pompe     disease, represent serious challenges in the healthcare system, no study has yet investigated     the prevalence of these diseases in the US. Frequently, patients show progressive worsening     of symptoms for several years before they get diagnosed. Since many of these diseases can be     managed therapeutically, it is important to identify and treat patients in order to avoid     organ damage. The investigators aim to undertake a screening study that identifies     undiagnosed patients with lysosomal storage disorders and determine the prevalence of these     diseases with special focus on underrepresented minority groups.   "
89069|NCT02120222|"     This phase I clinical trial studies the side effects of selinexor in treating patients with     melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as selinexor,     may stop the growth of tumor cells, by stopping them from dividing.   "
89070|NCT02120209|"     The primary objective of this study is to elaborate a new simple clinical tool for the risk     of falls among older inpatients.   "
89071|NCT02120196|"     The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for     secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis     and ascites.   "
89103|NCT02119780|"     This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with     Restylane SubQ™ injected into the anteromedial malar region.   "
89207|NCT02118428|"     The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole     Blood to prevent Malaria transmission by transfusion of whole blood.   "
89208|NCT02118415|"     Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients     with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)   "
89072|NCT02120183|"     This is a study to determine the effectiveness of a Group Therapy that provides     psycho-education and support for caregivers of cancer patients. Caregivers must be between 21     and 64 years of age and be willing to attend a one-hour a week program for four weeks. The     sessions will be in English, and a set of questionnaires (demographic data, some information     about your family member with cancer, and scales: Caregiver Quality of Life-Cancer Scale     (CQOLC), Perceived Stress Scale and the Hospital Anxiety Depression Scale (HADS)) will be     completed at the start, at 4 weeks, at 8 weeks and at 12 weeks. Some participants placed on a     wait-list to start the Group Therapy 4 weeks later will also complete the set of     questionnaires at this point. A Feedback and Satisfaction Questionnaire will be completed at     the end of the 4 week program. In addition, at the end of the 4 week program, some     participants will go through a 15-minute interview.   "
89073|NCT02120170|"     There have been very limited evidence about the bleeding complication during colon     polypectomy for the patients taking warfarin.      This study is aimed to analyse the effect of prophylactic hemo-clipping during colon     polypectomy for the patients with warfarin consumption.      The enrolled subjects are the patients who take warfarin for high thromboembolism risk and     should take heparin bridging therapy during colon polypectomy instead of temporary stopping     warfarin. The investigators will randomize into two groups; the patient enrolled into group 1     will be performed hemoclipping for all polypectomy lesion irrespective of the presence of     immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping     only for the lesion of immediate bleeding during colon polypectomy.      The primary endpoint is to compare the rate of delayed bleeding between two groups.   "
89074|NCT02120157|"     We propose a multi-institutional phase II haplo-identical T cell replete BMT study in     children with high-risk leukemias. The myeloablative conditioning regimen prescribed will be     TBI-based for lymphoid leukemias and busulfan-based for myeloid leukemias. Our goal is to     establish an easily exportable, inexpensive platform for haplotransplantation that has a     safety profile equivalent to matched related and unrelated BMTs. The primary objective will     be to estimate the incidence of 6-month non-relapse mortality, hypothesizing that NRM is <     18%.   "
89075|NCT02120144|"     The aim of study is to examine the combined effect of observation and imagination of gait on     stride time variability of stride time among in healthy young and older adults.   "
89076|NCT02120131|"     the purpose of this study was to test the effectiveness of the envelope flap compared to     trapezoidal flap in impacted mandibular third molar extractions.   "
89077|NCT02120118|"     The primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment     failure solid tumors are tumor response rate, while secondary goals are rates of acute and     late adverse effects, local control rate, distant metastasis rate, progression-free rate and     overall survival rate.   "
89078|NCT02120105|"     The purpose of this study is to determine whether urinary cystine capacity, an assay used to     measure the amount of cystine in the urine, can be used to predict stone recurrence in     patients with cystinuria.   "
89079|NCT02120092|"     Background: Coronary heart disease is the most common cause of death in industrialized     countries. Revascularisation by percutaneous coronary angioplasty or thrombolysis is the main     principle for treatment of the acute coronary syndrome. To inhibit platelet activity patients     are routinely given acetylsalicylic acid (ASA) and clopidogrel, a second-generation     thienopyridine. Recently, ticagrelor, a novel cyclopentyl-triazolo-pyrimidine with several     pharmacological advantages, has demonstrated greater efficacy but a higher bleeding risk than     clopidogrel. Coronary thrombus formation is a complex process and the antithrombotic     mechanisms of platelet function inhibitors are incompletely understood. Studies in venous     blood or in vitro do not truly reflect the in vivo circumstances as they often do not take     into account flow conditions or the interaction between endothelium, blood cells and     coagulation factors. Results from animal models may not be relevant for the prothrombotic     mechanisms in humans. We have developed a technique that allows investigating hemostatic     system activation directly at the site of thrombus formation in vivo in humans.      Aim: to compare the inhibitory effects of clopidogrel and ticagrelor (with and without     concomitant ASA) on hemostatic system activation under circumstances close to the in vivo     situation.      Design, patients and interventions: prospective, randomized, double-blind, placebo controlled     parallel-group study with a 2x2 factorial design including 112 healthy volunteers who will be     randomised to 4 treatment arms: ticagrelor or clopidogrel + placebo, ticagrelor or     clopidogrel + ASA.      Outcome variables: Indicators of platelet and coagulation activation [ß-thromboglobulin and     thromboxane B2 as well as prothrombin fragment F1+2 and D-Dimer, respectively] will be     measured before and at several time points during a 8 day period in venous blood and in blood     emerging from a standardized injury of the microvasculature to determine bleeding time (shed     blood).      Statistical considerations: Sample size calculation is based on the percent change in the     main outcome variable β-TG in shed blood from baseline to 2 hours after treatment start.     Statistical analysis is based on the full analysis set, including all randomized subjects who     received at least the starting dose of the study medication and for whom blood collections at     baseline and at 2 hours after treatment start have been performed.   "
89080|NCT02120079|"     Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse     therapy, administered twice daily (to avoid adverse effects associated with long-term steroid     use). This time frame is often too short to meaningfully resolve the inflammation associated     with DED. DED often occurs when there is a decrease in the eye's tear production or if there     is an increase in the evaporation of the tear film (a thin layer of tears that keep the eye     moist). Eye irritation and inflammation (swelling) is often associated with DED because the     surface of the eye is unable to maintain a normal level of moisture.      This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be     used to confirm clinical findings (which are noted by the doctor during an eye exam) and     measure the immune response to the inflammation in the subject's cornea (the front part of     the eyeball).      IVCM is a non-invasive imaging technique that images the cornea at a cellular level with 800x     magnification, using a scanning laser. The laser is used to map the cornea, and will not     damage or harm the subject's eye. Studies have shown that IVCM can be used to study cells and     nerves within the cornea, providing a better understanding of how the cornea reacts to     irritants. IVCM has recently been used by the investigator to assess the extent of eye     inflammation in cases of dry eye patients.      Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax     and artificial tears, in treating the inflammation associated with DED by measuring changes     in immune cells with IVCM imaging. The subject will be treated with either Lotemax     (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an     FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED.     Artificial tears are approved by the FDA for treatment of dryness associated with DED.      Thus, this study is designed to determine the effects of the administration of a topical     steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting     efficacy. In order to achieve the aforementioned goal, subjects will be prospectively     randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow     the same study schedule.   "
89081|NCT02120066|"     Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant     tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial     macroanuerysms.   "
89229|NCT02118142|"     People with poor insulin sensitivity do not respond normally to elevations in blood sugar.     This may increase their risk of developing diabetes in the future. The purpose of this     research study is to determine if the nutrient betaine, found in beets, spinach and wheat     products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is     believed to promote insulin sensitivity.   "
89082|NCT02120053|"     More than 2 million French people suffer from the widespread disability of edentulism, with     large consequences on function, nutrition, aesthetics and well-being. Complete denture is a     common therapeutic strategy.      The immediate complete denture technique consists in placing the denture in the same clinical     session as last anterior teeth extractions. With this technique, aesthetic and function are     immediately reintroduced and the patient is never left toothless or without any denture.      After teeth extractions, alveolar healing process leads to ridge resorption with bone volume     modifications and reduction in height and width.      However ridge bone volume is an essential factor in removable denture stability. With     implantology as an alternative prosthetic strategy, ridge volume is also a most important     factor to place dental implants in a situation close to previous dental roots position. In     order to preserve bone volume, a current alternative strategy proposes to place bone     substitute materials in tooth sockets after extraction. This strategy was never evaluated     with the immediate complete denture technique.      Hypothesis: A new strategy associating immediate complete denture and bone substitute     material is more effective than conventional immediate complete denture in a bone     preservation perspective.   "
89083|NCT02120040|"     Von Hippel-Lindau (VHL) disease is a severe autosomal dominant genetic disorder (with almost     complete penetrance) that predisposes to many tumors including some associated with a poorer     outcome. Clear cell renal cell carcinoma (CCRCC) is the leading cause of mortality.      The diagnosis of VHL disease may be challenging because tumors have an asynchronous and     multi-organ development and there is often no apparent hereditary context. As it is admitted     that VHL disease is underdiagnosed, some countries have decided to recall patients presenting     one of the potentially VHL disease-associated tumors to screen them for VHL mutation.     Screening is currently recommended in guidelines but many patients may have not been     previously screened.      Hemangioblastoma (HB) of the Central nervous system (CNS) is one of the typical VHL tumors     and up to 20% of patients with HB show VHL mutation. VHL diagnosis in this population enables     the diagnosis of other tumor types at an early stage of development since HB is     chronologically the second tumor occurring during the VHL disease history.      But it raises critical problems and questions: difficult announcement of a potentially severe     disease and psychosocial dimension related to inheritance of the disease.   "
89084|NCT02120027|"     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial     aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as     compared to placebo in women with IBS-D over a 24-week treatment period.   "
89086|NCT02120001|"     The purpose of this study is to test the efficacy of a novel cleaning device in keeping     silver-coated endotracheal tubes free from bacterial colonization.   "
89087|NCT02119988|"     The purpose of this study is to determine whether TIPS combined with variceal embolization     are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.   "
89088|NCT02119975|"     Dysfunctioning executive functioning, including working memory (WM), is related to     rumination. Findings show that working memory capacity (WMC) can be increased by training.     The current study explored by means of a double-blind randomized controlled trial whether an     adaptive WM training could reduce rumination, anxiety and depression in a sample of 98     depressed and anxious individuals.   "
89089|NCT02119962|"     Burnout patients show deficient working memory functioning. Several studies showed a training     can increase working memory capacity. In the current study we explored whether training     working memory can reduce burnout and burnout related symptoms and increase working memory     capacity.   "
89090|NCT02119949|"     Background: Substance abusers show impaired working memory (WM) functioning. Promising     findings show training WM results in an improved working memory capacity (WMC) and a decrease     of clinical symptoms in a range of disorders, including alcohol addiction.      Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance     use, craving, WMC, impulsivity, attention bias and psychopathology.      Design: A randomized double-blind placebo-controlled trial with a parallel group design. The     WM training adapted to participants' WMC whereas the placebo training consisted of     non-adaptive easy versions of these tasks.      Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands.      Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who     were in treatment as usual .      Measurements: Primary outcome measures: Substance use and craving. Secondary outcome     measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed     before and after 24 sessions of WM training as well as two months after the training.   "
89091|NCT02119936|"     Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback     tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests     that Heart Rate Variability Biofeedback can improve the threshold of stress management and     improve executive functioning. Additionally HRVB has been shown to significantly reduce     anxiety features in women suffering from perinatal depression. The investigators hypothesize     that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy     complications, who are at high risk for depression and anxiety.      Participants: Expecting mothers hospitalized for pregnancy complication, who are at high risk     for depression and anxiety.      Procedures: The investigators plain to use a heart rate variability biofeedback tool to     measure stress reduction in hospitalized expectant mothers. This tool will be couples with     validated surveys and scales, high frequency heart rate variability, saliva samples, and     qualitative interviews to quantify the reduction in stress from the HRVB tool.   "
89230|NCT02118129|"     The purpose of this study is to examine whether a behavioural intervention changes attitudes,     knowledge, intake or blood levels of vitamin D in young adults. The hypothesis is that an     educational component and use of a mobile smartphone 'app' will increase knowledge and/or     intake of vitamin D.   "
89308|NCT02117102|"     Urinary tract infection is most common serious bacterial infection in children who admit into     the emergency department (ED). However the collection of urine from young children is time     consuming process. So many children and their family guardian waste time until medical     disposition established.      In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique     for newborn, that bladder and lumbar stimulation technique is fast and safe.      The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation     technique (BLST) for pediatric patient in ED.   "
89092|NCT02119923|"     Anxiety and depression are both associated with impairments in executive functions, including     working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due     to these WM impairments anxious and depressed individuals have difficulties inhibiting and     shifting from irrelevant (negative) information and updating goal relevant information. This     study explored whether training WM decreases these impairments and reduces clinical symptoms     and rumination. Eighty-four individuals diagnosed with major depression and forty-nine     individuals with an anxiety diagnosis executed WM or control tasks three times a week, during     four weeks. Before, after training and at a two months follow-up measurement depression and     anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only     result in a reduction of anxiety symptoms in the depression group. These findings are     inconsistent with promising results of individual studies showing training WM result in an     enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are     in line with recent meta-analyses and reviews which show that WM training do not lead to     generalized effects and therefore, doubt the clinical relevance of WM training programs.   "
89093|NCT02119910|"     This investigation proposes to examine the effectiveness of a technology supported treatment     manual for pediatric feeding disorders. Children with pediatric feeding disorders display     intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent     appropriate nutritional intake during meals and lead to a number of negative and potentially     life threatening medical outcomes, including chronic malnutrition, growth retardation, and     placement of a feeding tube. To date, behavioral intervention involving extinction-based     procedures represents the only treatment for pediatric feeding disorders supported by     research to improve mealtime behaviors. Due to the chronic and extreme nature of food     refusal, treatment typically requires intensive, daily intervention conducted at highly     specialized clinics to improve feeding behaviors. The cost and duration of intervention can     total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential     for serious consequences associated with chronic food refusal, combined with the high cost of     treatment, intensifies the need to identify means to disseminate effective treatment     approaches to the broader community of healthcare providers.      The proposed study represents the first attempt to systematically investigate the use of a     treatment manual to address chronic food aversion through a randomized, waitlist control     trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program.     This study will involve a total of 20 participants randomly assigned to experimental     conditions: technology supported treatment manual or waitlist control group (10 in each     group). Children assigned to the waitlist control group will receive the technology supported     treatment manual after the specified time on the waitlist. All participants will receive the     same behavioral protocol involving three treatment sessions per day (45 minutes in length),     for a total of 15 sessions across five consecutive days. Data will be collected on feeding     behaviors during each treatment session and at follow-up using trained observers to collect     data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and     grams consumed. This type of data collection and treatment is standard practice in the     feeding disorders program; however, the use of a touch screen application for data capture     with integrated manual is novel to this project.   "
89094|NCT02119897|"     Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently     affects children undergoing hematopoietic cell transplantation (HCT). As a result of     intensive conditioning with chemotherapy with or without total body irradiation, and in the     case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk     for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and     suffering, increased utilization of opioid analgesics, and the need for intravenous or total     parenteral nutritional support. Patients universally report OM as being the worst aspect of     the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to     treat the at risk tissues from an extraoral approach, enabling exposure of the oral,     oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and     requiring only minimal patient cooperation. In this research study, the investigators are     assessing the feasibility of providing extraorally delivered low level light therapy (LLLT)     for the prevention of OM in children undergoing myeloablative HCT.   "
89095|NCT02119884|"     The purpose of the study is to find patients's response to terlipressin and octreotide during     hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.   "
89096|NCT02119871|"     To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral     pulmonary collapse for cardiac de-airing in open left-sided heart surgery.   "
89097|NCT02119858|"     This clinical trial studies diffuse optical imaging with indocyanine green solution in     imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery.     Indocyanine green solution is a special dye that can help doctors see the lymph nodes and     blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine green     solution may improve the ability to detect lymph nodes and may lead to improved accuracy of     lymph node removal.   "
89098|NCT02119845|"     The primary objective of this clinical study is to evaluate the preliminary safety and     effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)     in patients requiring chronic hemodialysis.   "
89099|NCT02119832|"     The primary objective of this clinical study is to evaluate the preliminary safety and     effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)     including coiling of the brachial vein during the index procedure in patients requiring     chronic hemodialysis.   "
89100|NCT02119819|"     The main purpose of this study is to compare the safety and effectiveness of the study drug     known as LY2944876 to exenatide extended-release and placebo in participants with type 2     diabetes mellitus. All drugs will be given by an injection under the skin. Participants     remain on stable doses of metformin, as prescribed by their personal investigator if they     were on metformin at study entry. Participants involvement in the study is expected to last     about 30 weeks.   "
89101|NCT02119806|"     In critically ill surgical patients, delirium (confusion and disorientation) is extremely     common and is associated with longer hospital length of stay, mortality, cost, and long term     cognitive impairment. The goal of the study is to establish whether benzodiazepines (a     sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by     comparing the chances of delirium in cardiac surgery patients between two groups: a group     that receives benzodiazepines during surgery versus a group that does not receive     benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac     anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to     keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for     intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner     preference. Findings of this study will allow all anesthesiologists to make more informed     decisions about what level of care our patients need.   "
89102|NCT02119793|"     This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of     YVOIRE® contour injected into the anteromedial malar region in subjects who have completed     the LG-HACL014 study.   "
89104|NCT02119767|"     The Liquid Biopsy System (LBS) is a new catheter (thin tube) designed for sampling blood     directly from coronary arteries. These arteries supply blood to muscles of the heart and can     become blocked by 'plaques' leading to chest pain (angina) and heart attacks. Recent research     has shown that development of ' plaques' inside coronary arteries is controlled by chemicals     (biomarkers) released into the blood from damaged areas of the artery wall. The LBS is     designed to collect blood samples at the exact site of plaque formation. By testing these     blood samples for biomarkers of plaque formation, it is hoped that new diagnostic tests and     treatments for heart disease may be developed. The proposed investigation is use the LBS in     humans to detect these biomarkers. The safety of the LBS has already been demonstrated in     both human and animal studies. The study will enroll 70 patients with coronary artery disease     who are undergoing routine percutaneous coronary intervention (PCI). PCI is a procedure used     to open up a blocked coronary artery. It uses a catheter on the end of which is a special     balloon that is inflated inside the blocked artery to open up the vessel and restore blood     flow. A small metal spring (stent) is usually inserted to keep the blood vessel open. This     study will test if the LBS device, when used just prior to a PCI procedure, can detect     biomarkers released by diseased coronary arteries. The study will also determine if the     presence of these biomarkers is linked to the long term health of the patient. The study will     take place at Papworth Hospital, over a period of approximately 8 months (including telephone     based patient followup calls 30 days, 6 months, 1, 2 and 3 years after the procedure to     determine patient health).   "
89105|NCT02119754|"     This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects     (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA     criteria) having full thickness (i.e., through the dermis but not involving joint capsule,     tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and     meet all other entry criteria to be enrolled and receive PluroGel PN.   "
89106|NCT02119741|"     Objective and background: The aim of this study is to evaluate the clinical outcome of using     the hyaluronic acid gel in reconstructing inter-dental papillae at the aesthetic zones in a     follow-up period of six months.      Materials and Methods: 30 interdental papilla deficiencies which would meet the the inclusion     criteria will be evaluated. After applying local anesthesia, 0.2 ml hyaluronic acid gel will     be injected at the affected areas. This procedure will be repeated 3 times for the evaluated     areas. Photographs will be taken before injection this material, and at 3 and 6 months     following the intervention.   "
89107|NCT02119728|"     This randomized phase II trial studies how well photodynamic therapy with HPPH works in     treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses     HPPH that becomes active when it is exposed to a certain kind of light. When the drug is     active, cancer cells are killed. This may be effective against squamous cell carcinoma of the     oral cavity.   "
89108|NCT02119715|"     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have     shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and     prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the     safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following     chemotherapy in patients with breast cancer.   "
89109|NCT02119702|"     This is a prospective cohort study designed to define the impact of HIV infection and     antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition     into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a     similar sociodemographic background and age distribution will be enrolled for comparison.   "
89110|NCT02119689|"     The purpose of this research study is to study blood stem cells in diabetic patients and     normal patients. We would like to better understand if these cells, called endothelial     precursor cells (EPCs), are not working as expected in people with diabetes. We would like to     see if the function of these cells can predict the development of diabetic retinopathy.      Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the     retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding     in the retina. Even with current treatments, the quality of life for people with diabetic     retinopathy is much reduced.   "
89111|NCT02119676|"     The purpose of this study was to determine if ruxolitinib, in combination with regorafenib,     is safe and effective in the treatment of metastatic colorectal cancer.   "
89112|NCT02119663|"     This was to determine the efficacy, based upon overall survival, of ruxolitinib added to     capecitabine for the treatment of metastatic pancreatic cancer.   "
89113|NCT02119650|"     The purpose of this study was to determine if ruxolitinib, in combination with     Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of     nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.   "
89114|NCT02119637|"     Background:      - Different parts of the brain are involved in feeling touch. Researchers want to study     whether repetitive magnetic stimulation (rTMS) to the sensory cortex affects how sensation     feels. rTMS is a repeated magnetic pulse that interferes with brain activity. It affects a     small part of the brain beneath the scalp. Researchers want to find out the role of sensory     cortex in sensing different types of touch.      Objectives:      - To find out the role of sensory cortex, a brain area, in sensing different types of touch.      Eligibility:      - Healthy adults ages 18 45.      Design:        -  Participants will be pre-screened with a telephone interview. Then they will be screened          with physical and psychological exams and a urine test.        -  In Session 1, participants will have an MRI brain scan and fill out questionnaires.        -  For MRI, a magnetic field and radio waves take pictures of the brain. Participants will          lie on a table that slides in and out of a metal cylinder. A coil will be placed over          their head. They will perform a task during the scan. The scanner makes loud knocking          noises. Participants will get earplugs. They will be in the scanner for up to 60          minutes.        -  In Sessions 2 and 3, participants will take Breathalyzer and urine tests. Their          perception of touch will be measured. Then rTMS will be used to stimulate their sensory          cortex and scalp for about 20 minutes. Their perception of touch will be measured again.        -  For rTMS, a wire coil is held on the scalp. A brief electrical current passes through          the coil and creates a magnetic pulse that affects activity in the brain.   "
89115|NCT02119624|"     Background:      - People who are dependent on alcohol drink even when they know something bad might happen.     Researchers want to learn more about why they do this.      Objectives:      - To study brain response when a person plays a game in different threat conditions.      Eligibility:        -  Healthy right-handed adult heavy drinkers age 21 60        -  Healthy right-handed adult light drinkers age 21 60      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests. They will have an EKG and psychiatric interview.        -  Participants will have one or two clinic visits.        -  Participants will be asked about their alcohol drinking.        -  They will choose a snack and alcoholic beverage that they must drink in 5 minutes. After          their breath alcohol content (BrAC) is zero, they will play a game in the MRI scanner.        -  The scanner is a metal cylinder that takes pictures of the brain. Participants lie on a          table that slides in and out of the cylinder. They will be in it for about 90 minutes,          lying still for up to 20 minutes.        -  During the MRI, participants will play a simple computer game to earn food or drink          points under different threats of electric shock. Points can be exchanged for food or          alcohol after the game. Sometimes, participants will receive a mild electric shock          through a metal disk on the wrist. Electric shocks will only happen if the participant          tries to earn a reward point.        -  After the MRI, participants use their points for another drink and snack. They will stay          at the clinic until their BrAC is low, usually within 3 hours. Participants cannot drive          themselves home.        -  Participants will have a follow-up phone call the next day.   "
89116|NCT02119611|"     Background:      - In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest.     It is attached to wires in parts of the brain that affect movement. DBS might help people     with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).      Objective:      - To provide DBS treatment to people with some movement disorders.      Eligibility:      - Adults 18 years and older with PD, ET, or certain forms of dystonia.      Design:        -  Participants will be screened with medical history and physical exam. They will have          blood and urine tests and:        -  MRI brain scan. The participant will lie on a table that slides in and out of a metal          cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will          get earplugs for the loud noises. During part of the MRI, a needle will guide a thin          plastic tube into an arm vein and a dye will be injected.        -  Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and          legs. They record heart activity.        -  Chest X-ray.        -  Tests of memory, attention, concentration, thinking, and movement.        -  Eligible participants will have DBS surgery. The surgery and hospital care afterward are          NOT part of this protocol.        -  Study doctors will see participants 3 4 weeks after surgery to turn on the          neurostimulator.        -  Participants will return every month for 3 months, then every 3 months during the first          year, and every 6 months during the second year. Each time, participants will be          examined and answer questions. DBS placement will be evaluated with MRI. The          neurostimulator will be programmed. At two visits, participants will have tests of          movements, thinking, and memory.   "
89117|NCT02119598|"     Research on prehospital telestroke systems is recommended by the American Stroke Association,     as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of     patients for specific stroke treatments      The experience with prehospital telemedicine for assessment of stroke severity is limited.     Prehospital telestroke is a very promising concept, facilitating specialized stroke care in     very early stage based on integration of bidirectional audiovisual communication with point     of care laboratory analysis, vitals and decision support software.      The aim of this prospective study is to investigate the safety, the technical feasibility and     the reliability of in-ambulance telemedicine using a prototype third generation telemedicine     system (PreSSUB 3.0).   "
89118|NCT02119585|"     During orthotopic liver transplantation (OLT), respiratory system function may be severely     impaired for several reasons including anaesthesia effects, hyperdynamic volume state with     fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is     characterised by the release of several inflammatory mediators such as cytokines and oxygen     free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of     this study is to investigate the respiratory system mechanics impairment in its partitioning     between lung and chest wall.      We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall)     occurs after reperfusion phase of liver. This impairment is associated with the systemic     inflammatory response following liver reperfusion.   "
89119|NCT02119572|"     The prevalence of diabetes has been growing rapidly in developing countries causing a     devastating economic burden and increasing demands on healthcare systems. Therefore, there is     an urgent need to find cost-effective and multi-faceted approach for diabetes care. Peer     support models provide a potentially low-cost, flexible means that is complimentary to the     current existing health care services. Trained peer leaders can become qualified extenders to     a formal healthcare system, thereby, assisting with the education delivery and bolstering the     efforts of the professional staff. To implement a culturally- specific peer support program     and determine whether it is acceptable, cost-effective in China is important. This study aims     to implement and evaluate biophysical and psychosocial outcomes of a peer support program and     to explore it's feasibility and sustainability in China   "
89129|NCT02119442|"     A growing body of data, suggests that transcatheter valves are effective when implanted in     other locations (mitral, aortic, tricuspid) and in high pressure environments. The     investigators plan to offer transcatheter valve implantation as an alternative to high risk     surgery in patients who require revision of a stenotic or regurgitant valve in the     non-pulmonary position (mitral, aortic, tricuspid). This therapy can provide an alternative     to patients who may be considered high risk and may not be able to survive a surgical     procedure.The use of the devices on this protocol are for medical treatment and are not part     of a clinical trial.   "
89130|NCT02119429|"     The purpose of this study is to determine whether or not there is an effect of pumpkin seed     oil supplementation, 2 grams per day, on blood pressure (systolic and diastolic) in     premenopausal women.   "
89243|NCT02117960|"     The aim of this study is the comparison between the effects of supplementation with omega 3     or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with     cardiovascular disease.   "
89120|NCT02119559|"     In France, the incidence of head and neck squamous cell carcinomas (HNSCC) is 16 000 new     cases/year. During these last years, many new chemotherapies and targeted therapies have been     developed improving significantly the overall survival of patients notably anti-HER     molecules. In inoperable recurrent and/or metastatic HNSCC, the best treatment is based on an     anti-Human Epidermal Growth Factor Receptor (EGFR) antibody, targeting Human Epidermal Growth     Factor Receptor 1 (HER1), the Cetuximab combined with platinum +/- 5 Fluoro Uracil (5FU):      Extreme protocol . However, no clinical or biological criteria predictive of drug efficacy     have been reported yet. Thus, the development of such a predictive factor is an urgent need     in HNSCC at both the clinical and pharmacy-economic level, to propose the best personalized     treatment. One idea would be to enumerate and characterize the circulating tumor cells (CTC)     which could give us an early evaluation of the therapeutic efficiency. In this context, the     investigators have developed an innovative technology, the EPISPOT assay (patent of the     University Medical Center of Montpellier), that allows the detection & characterization of     viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the     breast and prostate cancer.Thus, the investigators would like for the first time to perform a     prospective study on a cohort of patients treated following the Extreme protocol, with this     technology, to assess the predictive value of CTC count. The investigators will use the     CellSearch® system as the reference test.   "
89121|NCT02119546|"     The purposes of this study are:        1. To investigate whether a 3-month exercise training program would improve cognitive          function, motor performance, integrity of brain fiber tracts and cerebral blood flow;        2. To investigate the possible neuro-anatomical and neurophysiological mechanisms of          exercise training on cognitive function, motor performance, integrity of brain fiber          tract and cerebral blood flow in patients with mild cognitive impairment and in those          with early Alzheimer's disease;        3. To investigate the influence of different apolipoprotein E (APOE) genotypes on the          above-mentioned exercise effects.      The results of this study will provide medical evidence for the effects of exercise training     on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding     of the mechanisms mediating these effects. More importantly, the results serve as the basis     for future larger-scale exercise clinical trials for these two patient populations.   "
89122|NCT02119533|"     Mild brain injury or concussion affects about four million Americans each year. Some people     recover completely while others, especially those with multiple concussions, develop chronic     headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that     concussion is difficult to treat is that it is difficult to detect. Radiographic studies such     as CT (computed tomography scan) are by definition unrevealing of structural injury in     concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in     the diagnosis of concussion but even these are not consistently present in all patients with     symptoms. Clinical tests for concussion often require baseline studies, and thus are     generally reserved for athletes and others at highest risk for concussion.      The investigators have developed a novel eye movement tracking algorithm performed while     subjects watch television or a music video that determines whether the eyes are moving     together (conjugate) or are subtly not together (disconjugate). The investigators preliminary     data shows that people with lesions in their brain or recovering from brain injury have     disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our     algorithm.   "
89123|NCT02119520|"     Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with     open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis     subjects.   "
89124|NCT02119507|"     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the     treatment of early approximal carious lesions compared to no treatment.   "
89125|NCT02119494|"     The purpose of this study is to assess the representation of COPD patients in terms of     categories and phenotypes of the disease in selected countries in Central and Eastern Europe     (CEE). The results of The POPE study will allow for evaluation of the differences in clinical     approaches and treatment practices. The following countries are represented in The POPE     study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia,     Estonia, Latvia and Bulgaria.   "
89126|NCT02119481|"     The primary aim of this study is to examine the effects of a mindfulness-based stress     reduction training program, delivered in individual web-based sessions, among breast cancer     patients. The objectives are to study and answer questions regarding effects of the such     training in a randomized controlled trial including the following outcome measures: physical     and mental health status, perceived stress, post-traumatic stress symptoms, psychological     well-being, and sleep quality. In addition to the primary aim, the investigators plan to     explore potential mechanisms through which mindfulness training lead to improvement in     perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.   "
89127|NCT02119468|"     This phase I/II trial studies the side effects and best dose of ixazomib and to see how well     it works when given together with pomalidomide and dexamethasone in treating patients with     relapsed or relapsed/refractory multiple myeloma. Ixazomib may stop the growth of cancer by     interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide and     dexamethasone can modify and regulate the immune system and may stop cancer cells from     growing. Giving ixazomib with pomalidomide and dexamethasone may be an effective treatment     for relapsed or relapsed/refractory multiple myeloma.   "
89128|NCT02119455|"     Currently, orthodontic treatment typically lasts approximately 2 years. There are a number of     advantages for reducing the duration of treatment, including reducing the potential risk of     caries, root resorption and for minimizing patient burn out from prolonged treatment.      While some evidence does exist that vibration may accelerate the speed of tooth movement, the     biological mechanism is still unknown. Identification of specific factors involved in tooth     movement that are further stimulated by vibration would help to understand the mechanisms     involved as well as discover possible biologic targets which could be utilized or modified to     maximize the benefits of vibration treatment.      The purpose of this study is to identify novel biological factors that are expressed in     patients undergoing orthodontic tooth movement in conjunction with vibration appliance     therapy.   "
89133|NCT02119390|"     Although effective treatments are currently available to treat human immunodeficiency virus     (HIV), the retrovirus leading to acquired immune deficiency syndrome (AIDS), strict adherence     to the treatment regimen is required. Nonadherence to highly active antiretroviral therapy     (HAART) regimens is well documented in individuals with HIV. This is especially true for     adolescents and young adults (AYA), where rates of adherence range from 20 to 100%.     Nonadherence has significant implications for subsequent treatment response and health     outcomes, including poor virologic response, development of drug resistance, and mortality.     Of note, previous research has suggested that every 1% increase in nonadherence is related to     a 2% increased likelihood of detectable viral load (VL) in youth with behaviorally acquired     HIV. Furthermore, higher VL is the most salient variable related to increased risk of virus     transmission. Thus, nonadherence to HAART is a significant public health issue.      The objective of the proposed research plan is to systematically examine an individualized,     behavioral intervention targeting HAART nonadherence in AYAs initiating HAART. The current     intervention will support AYA participation in brief, staff-delivered instruction in     adherence-promotion skills. Individualized behavioral analysis and motivational interviewing     will be applied to provide effective solutions for current barriers to HAART adherence before     and after HAART initiation, as recommended by the Panel on Antiretroviral Guidelines for     Adults and Adolescents.   "
89134|NCT02119377|"     This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years     and older living in Australia. This population has received limited attention from public     health researchers, planners, and practitioners. However, a growing body of evidence suggests     that trans people experience disparities in several important areas of health compared with     the population generally. In particular, trans people are more likely to experience mental     health problems (notably depression and anxiety disorders), use alcohol, tobacco, and illicit     drugs, and think about or attempt suicide. Additionally, trans people commonly report that     their physical and mental health needs are not met, and underutilise preventive health care.      Participants were recruited using several non-probability sampling techniques, (including     purposive sampling and snowball sampling), because random sampling is not possible with this     population. Medical, social, support, and advocacy networks used by trans people were used to     promote the study. A mixed quantitative and qualitative methodology was used. Validated     quantitative instruments were used to obtain measures of health and well-being, which will be     compared against population norms. Qualitative items complement these measures, providing     rich experiential data.      The investigators hypothesised that:        -  the prevalence of depressive and anxiety disorders will be higher than for the          population generally, and that these conditions will commonly be undiagnosed and          untreated;        -  depressive and anxiety disorders will be associated with risky behaviours, such as          tobacco, alcohol, and illicit drug use; and,        -  trans people will report poor relationships with medical practitioners.      The investigators hypothesised that poor mental health is a consequence of several     interrelated factors: body dysphoria (as a consequence of experiencing difficulty accessing     medical treatment to alter sexual characteristics); societal discrimination and stigma     (including harassment and violence); institutionalised discrimination (including difficulty     changing identifying documents, and exclusion of surgical procedures and related treatments     from public and private health systems); social isolation; and the belief held by many     clinicians that transsexualism is a mental disorder (which may be a barrier to trans people     forming trusting relationships with medical practitioners).   "
89135|NCT02119364|"     Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live     born), and is frequently accompanied by cognitive impairments and behavioural problems. The     present study is a controlled clinical trial, a multicenter-study involving three health     regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary     research goal will be to evaluate the effects of computer-based cognitive training in     children with CP. In addition, this study will be the first to conduct a comprehensive     neuropsychological examination to improve our understanding of cognitive impairments as well     as cognitive resources in CP children in Norway to aid in intervention planning.   "
89136|NCT02119351|"     The objective of this post-market, prospective study is to evaluate the clinical     acceptability, blood leakage, risk for blood exposure, need for digital compression,     insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to     standard hospital PIVCs currently being used.   "
89137|NCT02119338|"     The investigators propose a single-center, non-randomized, single-arm study at the Barrow     Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent     glioma study will correlate presence of fluorescence in tumor tissue with pathological     findings. This will be done using three cohorts in dose escalation. The investigators'     hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result     in less false positive fluorescence.   "
89138|NCT02119325|"     The primary aim of this study is to evaluate the effect of a fibre rich health food drink on     the post prandial glucose and triglyceride peak in healthy overweight adults with impaired     fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two     period cross over study.   "
89139|NCT02119312|"     The purpose of this study is to identify and screen potential subjects for preliminary     eligibility to participate in a malaria related clinical trial conducted at the Seattle     Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.   "
89140|NCT02119299|"     The purpose of this study is to demonstrate that (1) we will observe at least 40% of the     subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks     compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared     to Week 0 is ≥4% in the Per Protocol population.   "
89141|NCT02119286|"     After screening, subjects will enter a 4 week open-label run-in period with fluticasone     furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI).     Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide     [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once     daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing     treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a     total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1),     blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85     (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last     clinic visit. The total duration of subject participation in the study from Screening to     Follow-up will be approximately 17 weeks.   "
89223|NCT02118220|"     The purpose of this research study is to determine the number of children who have symptoms     of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's     Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed     concussion. This study is the first phase of a two-part study looking at the effects of     anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently,     the decision to continue with surgery in patients with a diagnosed concussion is based on     clinical judgment by the patients.   "
89142|NCT02119273|"     Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with     and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports     the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited     evidence to support their utility for CRSsNP. The investigators intend to perform a     randomized, double blind, placebo controlled clinical trial to investigate the impact of     steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present     to the investigators office will be included if they have failed maximal medical management     and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The     investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will     improve subjective and objective outcome measures.   "
89143|NCT02119260|"     This study is the first administration of GSK2798745 in humans. This will be a sponsor     un-blinded, placebo-controlled study to investigate the safety, tolerability,     pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2798745, given as single and repeat     oral doses to healthy subjects and stable heart failure (HF) subjects. Approximately 28     healthy subjects will be enrolled in the study cohorts (Cohort 1-3) involving single and     repeat dose escalations of GSK2798745, while up to 24 stable heart failure subjects will be     enrolled in Cohort 4 involving single and repeat dose administration of GSK2798745, with the     dose selected based on data from healthy subject cohorts. This would be followed by     enrollment of up to 8 subjects with heart failure in Cohort 5 involving repeat dose     administration of GSK2798745. The study duration, including screening and follow-up, is not     expected to exceed 17 weeks for subjects in the study (in any cohort).   "
89144|NCT02119247|"     The purpose of this study is to compare the systemic availability to CHF 6001 after a single     dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose     capsule inhaler Aerolizer®.      CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary     disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an     inhaler device. Previous studies were conducted using a single-dose capsule inhaler     (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device     will be used.   "
89145|NCT02119234|"     The study is performed to investigate the effect of the spacing device on the     pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without     Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients.     Moreover, the general safety and tolerability of the treatments will be evaluated.   "
89146|NCT02119221|"     The study aims to provide understanding of the relative relevance of the different excretion     pathways of Copanlisib in humans, as well as to characterize its metabolite profile.   "
89147|NCT02119208|"     1. In natural environment, the moderate-intensity break will allow a reduction of the          caloric intake at the dinner more important than for the light-intensity break        2. In natural environment, the break taken juste before dinner will allow a reduction of          the caloric intake at the diner more important than earlier in the day.   "
89148|NCT02119195|"     A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%)     and males (35%) with 80 composite restorations were recruited at the Operative Dentistry     Clinic at the Dental School of the University of Chile. All participants presented with     marginal adaptation clinical features that deviated from the ideal and were rated Bravo     according to the modified United States Public Health Service (USPHS) criteria for the     sealing group and no treatment group. As a positive control were considered composites with     alpha values in marginal adaptation. The protocol was approved by the Institutional Research     Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All     of the patients signed informed-consent forms and completed registration form. The selection     criteria are summarized below.   "
89149|NCT02119182|"     The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury     (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging,     cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI     from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical     trials, advance diagnostic and prognostic models for TBI and improve clinical trial design.   "
89150|NCT02119169|"     The effectiveness of pigtail catheter as a less invasive option for pleural drainage in     patients with resistant hepatic hydrothorax.   "
89151|NCT02119156|"     This study will assess the effect of a 24-week withdrawal followed by a 28-week     reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with     stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be     assessed for subjects who have permanently withdrawn from further belimumab treatment.   "
89152|NCT02119143|"     This study investigates the effects of a dietary supplement - a cocktail of vitamins and     minerals - on the incidence of common cold in a cohort of middle management employees.The     primary outcome is defined as the number of duty days lost due to common cold/flu. Further,     immune parameters and markers of redox biology/oxidative stress will be determined. The     wellbeing in the cohort will be evaluated via questionnaires.   "
89153|NCT02119130|"     The purpose of this study is to use a cluster randomized trial to compare the effectiveness     of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine     use of the tuberculin skin test (TST), the current standard of care for diagnosing latent     tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT     clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher     proportion of patients and in a significantly faster timeframe. The cost-effectiveness of     linking QGIT with routine CD4 compared to routine TST will also be evaluated, and the process     of implementation of QGIT into the routine cluster of differentiation 4 (CD4) blood draw will     be evaluated using a mixed method approach to identify steps that can be modified for future     scale-up of the intervention.   "
89292|NCT02117310|"     This is a feasibility study in which indocyanine green (ICG) will be administered during     routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal     flap harvest will be necessary. The research entails administering ICG, which is already     widely used during open neurosurgical procedures, to identify the blood supply at two     distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after     final positioning of the nasoseptal flap to ensure its viability before ending the case.   "
89154|NCT02119117|"     Pregnancy rates for women over 35 years old are significantly lower when compared to younger     women. One of the causes for this decrease is believed to be chromosomal aneuploidy.     Chromosomal aneuploidy is a natural phenomena and occurs in women of every age and has been     implicated in spontaneous miscarriages, and preimplantation embryo wastage (Hassold and Hunt,     2001).      As maternal age increases, so too does the incidence of chromosomal aneuploidy. Embryo     quality from older patients undergoing IVF tends to be reduced and associated with higher     rates of chromosomal abnormalities when compared to good quality embryos (Munne et al.,     1995).      Chromosomal aneuploidy derives from the improper segregation of chromosomes during     preimplantation development. The process of segregation, or mitosis, includes synthesis of     the complete genome, equal division of chromosomes to opposite poles by the spindle     apparatus, and separation of the two cells by cytokinesis, yielding two chromosomally     identical cells. The entire process of cellular and genetic replication requires energy in     the form of adenosine tri phosphate (ATP). ATP is mainly produced in mitochondria in the     process known as the electron transport chain (ETC). There are many important molecules     required for ATP production, CoQ10 can act as the appropriate carrier of electrons through     the ETC. When a deficiency in CoQ10 is present, ATP production is decreased resulting in     aneuploidy (Bentov et al., 2013). Similarly, research has shown that chromosome alignment and     spindle formation are affected by mtDNA copy number (Ge et al., 2012). It has also been shown     that the transfer of ooplasm from young, healthy oocyte donors into oocytes of women with     repeated embryonic failure has result in children with subsequent mitochondrial heteroplasmy     (Cohen et al., 1998).      CoQ10 concentrations have been shown to decrease as age increases (Bentov et al., 2011).     Consequently, the decrease in CoQ10 concentrations seen in older women may cause an increase     in chromosomal aneuploidy in subsequent embryos (Bentov et al., 2013). In this pilot study,     we test the hypothesis that the supplementation of CoQ10 prior to an IVF cycle can increase     mitochondrial DNA activity and possibly decrease chromosomal aneuploidy in AMA patients.   "
89155|NCT02119104|"     The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v)     in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months,     exclusive.   "
89156|NCT02119091|"     A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study:     Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy     Chinese volunteers and Caucasian Volunteers Study Objective:Primary Objective:To compare the     difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese     group and Caucasian group under the same exposure (Cmax) of Moxifloxacin.Secondary     Objectives:1)To compare the difference of ΔΔQTcF, heart rate, PR, RR, QRS and Moxifloxacin     plasma concentration between Chinese group and Caucasian group.2)To compare slopes of     Moxifloxacin plasma Concentration/QTcF value between healthy Chinese volunteers and Caucasian     Volunteers.   "
89157|NCT02119078|"     The purpose of this investigation is to assess the effectiveness of a multi-disciplinary     Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older     admitted to Oregon Health & Science University's hospital medicine service. The ACE program     will aim to improve the quality of care of older patients in the investigators hospital by     implementing focused interventions and recommendations specific to geriatric needs and     syndromes, including: reduced fall rate, decreased incidence and duration of delirium, early     recognition and treatment of impaired mobility and function, careful minimization of     medication use, prevention of unnecessary catheter and restraint use, decreased hospital     readmission rates, improved transitional care following hospital discharge, and high levels     of patient and referring physician satisfaction. Additionally, the ACE program aims to     improve resident and student competence in treating geriatric syndromes, and to improve staff     and learner satisfaction with caring for older adults. ACE programs have been well studied at     other institutions, so the investigators will be implementing a program that is already     standard of care, and studying the elements that are unique to OHSU.      This will be a quality improvement project. Study participants will be a convenience sample     of OHSU faculty, staff, residents and students who are employed by or on rotation with     General Medicine Team 1 of the Medicine Teaching Service. Faculty, staff, and learners (ACE     team members) will receive the ACE training. Study personnel will conduct prospective and     retrospective chart review of patients admitted to the ACE service to determine outcomes as     noted above.   "
89158|NCT02119065|"     This pilot clinical trial studies positron emission tomography (PET)/computed tomography (CT)     in finding beads after Yttrium-90 bead therapy in patients with primary liver cancer or     cancer that has spread to the liver (metastatic) that can not be removed by surgery. Imaging     procedures, such as PET/CT after Yttrium-90 bead therapy, may help see if the beads are     present in the lung and compare the results with the pre-therapy imaging.   "
89159|NCT02119052|"     Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a     variety of extrarenal manifestations of which polycystic liver disease is most common. The     investigators aimed to assess the changes over time of liver volume in ADPKD patients and     whether it is affected by the treatment with the somatostatin analogue, octreotide.      35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment     with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance     (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.   "
89160|NCT02119039|"     CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It     consists of large biopolymers, imitating the structure of heparansulphate. The protecting     effect on different biological tissues and enhancement of wound healing has been described in     several studies.      Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per     100,000 per year across different populations. Corneal collagen cross-linking represents a     treatment option for these patients, aiming to prevent progression of the disease via     stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet     A/riboflavin cross-linking procedure significantly improves the outcome of the intervention,     due to ameliorated distribution of riboflavin.      The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial     wound closure after collagen cross-linking in patients with keratoconus. Results may lead to     an improved management and pain reduction of patients with corneal epithelial defects.   "
89224|NCT02118207|"     SCUBA diving frequently involves repetitive exposures over multiple days. The goal of this     study was to see how exercise impacts microparticles (MPs), endothelial function, and venous     gas emboli (VGE) over a series of dives.      16 divers in 2 groups each completed 6 dives. One group completed 3 control dives followed by     5 days rest then 3 dives preceded by exercise. The other group completed the opposite     protocol. Flow-mediated dilation (FMD) data and blood for MP analysis was collected before     and after each dive. VGE were monitored via transthoracic echocardiography 30, 60, and 90 min     after surfacing. Exercise before diving consisted of 60 min running outdoors including 8x4     min intervals at 90% VO2max effort.   "
89161|NCT02119026|"     Since its introduction, 5-fluorouracil (5-FU) has been the cornerstone of treatment for     metastatic colorectal cancer (mCRC). Meanwhile the oral 5FU pro-drug Capecitabine (Xeloda®)     proved equivalence to 5-FU and is a well tolerated alternative combination partner for     Irinotecan (XELIRI) or Oxaliplatin (XELOX) which are widely used for first line treatment of     mCRC. Recent advances in molecular biology have resulted in the development of an inhibitor     of the vascular endothelial growth factor (VEGF) by the monoclonal humanized antibody     bevacizumab (Avastin®).      XELOX or XELIRI +bevacizumab have been investigated in several trials, but not in an approach     with clearly defined cross-wise XELIRI-XELOX change criteria. This trial investigates two     different sequential treatment options with XELIRI/ XELOX in first and second line with the     addition of bevacizumab and tries to give answer to the question if there is an optimal     sequence for the benefit of the patient.      This is a prospective, randomized, open-label, 2-arm pilot trial in patients with mCRC who     did not receive systemic treatment for their metastatic disease. The study is designed to     evaluate the efficacy of XELIRI followed by XELOX and XELOX followed by XELIRI + bevacizumab     in terms of Duration of Disease Control (DDC).      Patients will be treated with an established first line therapy consisting of either XELOX or     XELIRI + bevacizumab. The chemotherapy treatment will be given for 6 months except prior     disease progression, unacceptable toxicity or patient refusal. Bevacizumab will be given     until disease progression, unacceptable toxicity or patient refusal.      Capecitabine can be given in addition at the investigators' discretion until disease     progression, unacceptable toxicity or patient refusal.      If serious side effects occur despite adequate dose reduction, Oxaliplatin or Irinotecan     should be discontinued. In case of Oxaliplatin or Irinotecan-related discontinuation     Capecitabine and Bevacizumab should be continued. If Capecitabine also has to be discontinued     in first line treatment bevacizumab should be continued. In case of permanent discontinuation     of bevacizumab for toxicities, chemotherapy should be continued.      Upon completion of first line chemotherapy patients with disease control will receive     bevacizumab maintenance treatment. On investigators decision patients can receive     Capecitabine as additional maintenance treatment.      The primary endpoint is to determine the efficacy of a modified XELIRI + bevacizumab followed     by XELOX + bevacizumab scheme at progression in comparison with the reverse sequence based on     DDC.      Secondary endpoints are first line progression-free survival (PFS), second line PFS, overall     response rate, time to response, duration of response, overall survival, tumor assessments     (based on RECIST criteria) using CT scans, MRI scans, X-ray, bone scan, clinical examination.   "
89162|NCT02119013|"     Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset     hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with     LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic     function in ADPKD patients and whether they were affected by the treatment with the     somatostatin analogue, octreotide.      35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26     mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide     (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV     mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane     Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow     velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler     imaging.   "
89163|NCT02119000|"     Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment     of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure,     and is associated with decreased lesional detection rates. The ideal bowel preparation     formulation should be able to completely clean the bowel, without leaving solid or liquid     residues, and without modifying the mucosal appearance.      Bowel preparation may be administered in hospitalised patients or in the ER. Patients have     less control on their environment and the intake of the bowel preparation. For example, there     may be a delay in pharmacy delivery or inadequate supervision by the treating personnel.     Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both     can add to the barriers leading to an adequate bowel preparation. Multiple studies have     identified hospitalization status as an independent risk factor for poor bowel preparation.      The objective of this study is to access which bowel preparation regimen, between PEG 3350     with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350     with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the     cleanest bowel preparation in hospitalised patients.   "
89164|NCT02118987|"     This research study is evaluating a drug called omalizumab (brand name 'Xolair') as a     potential treatment to be used in conjunction with drug desensitization to prevent reactions     from recurring and allowing the participant to be treated with the chemotherapy the     participant's oncologist prefers to give.   "
89165|NCT02118974|"     Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic     surgery with little direct evidence that it is if not better than traditional laparoscopic     surgery, at least equivalent. We designed a randomized-controlled trial to compare operative     times, length of hospital stay, estimated blood loss, and post-operative complications     associated with these two methods of minimally invasive hysterectomy.   "
89166|NCT02118961|"     This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a     booster dose in adolescents.      The purposes of this study are as follows:        -  To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid          (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and          anti-tetanus toxoid (anti-T) antibodies        -  To confirm that booster responses for anti-pertussis toxoid (anti-PT) and          anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants          received BK1301   "
89167|NCT02118948|"     The purpose of this study is to develop and evaluate an HIV risk reduction intervention for     women with a history of abuse.   "
89168|NCT02118935|"     The study is intended to measure infant comfort, behavior, and sleep when consuming study     formula with prebiotics compared to infants who consume a study formula without the     prebiotics.   "
89169|NCT02118922|"     We have developed novel Brillouin microscopy and we are testing its potential for keratoconus     and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in     order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare     biomechanical properties of post-LASIK ectasia vs. normal corneas.   "
89170|NCT02118909|"     This study is designed as a 2-part, open-label study to assess the effect of pracinostat with     itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of     pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered     with itraconazole or ciprofloxacin.   "
89171|NCT02118896|"     The purpose of this study was to offer patients who had participated in one of the phase II     PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until     commercial availability of the drug and to record long term efficacy and safety data.   "
89172|NCT02118883|"     The purpose of this study is to examine and compare the rehydration effect of Essentia Water,     an electrolyzed high-pH bottled water, with industry-standard bottled water purified by     reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality, (3)     bioelectrical impedance analysis, and (4) body mass change, using serial measurements in     apparently healthy adults following exercise-induced dehydration in a controlled environment.   "
89173|NCT02118870|"     Background:      The optimal duration of dual antiplatelet therapy in ACS patients treated with DES is still     under debate. This is especially true for STEMI patients in the era of new anticoagulants and     antiplatelet agents. Yet, the potential benefits of longterm dual antiplatelet therapy in     avoiding thrombotic complications may be clearly counterbalanced by a higher risk of major     bleeding complications. In particular, the COMBO dual therapy stent, being associated with     early re-endothelization, may allow for a reduction of the duration of DAPT (dual anti     plateled therapy) without increasing the thrombotic risk, while reducing the risk of severe     bleeding complications.      Study Objective:      Aim of the current study is to demonstrate a non-inferiority of a strategy of short-term DAPT     (90 days) as compared to standard 360 days DAPT in ACS patients treated with Combo stent.      Study Design:      This study is a prospective, multicenter, randomized, investigator-initiated study designed     to enroll 1500 patients with ACS receiving a COMBO dual-therapy stent who will be randomized     1:1 to either short term (90 days) or to standard (360 days) DAPT. Patients will be     randomized within hospitalization (before discharge in case additional revascularization is     deemed necessary and performed during hospitalization). Clinical visit is scheduled at 90,     and 360 days, whereas a telephone contact will be performed at 180 and 720 days.      Patient Population:      The study population will consist of up to 1500 ACS patients (male and female) older than 18     years amenable to percutaneous treatment and treated with a COMBO stent. Subjects must meet     all of the eligibility criteria and provide written informed consent.   "
89174|NCT02118857|"     The human body houses a huge microbial ecosystem, including the intestinal and oral     microbiota. Both these ecosystems, and, in particular, the intestinal one, are responsible     for maintaining human health. The response of the organism to the diet and the relative     alteration of the susceptibility to disease are worth of investigation to comprehend the role     of the microbiota to maintain the state of well being in humans. This concept, which is the     overall scientific basis of the entire project, perfectly fits with the declared scopes of     Horizon 2020. Understanding the impact of omnivore, vegetarian and vegan diets on human     intestinal microbiota is aligned to the Grand Societal Challenge of the Horizon 2020 scheme,     which is addressing the human nutritional needs and the impact of food on human physiological     functions. In particular, studying the link between dietary habits and the intestinal     microbiota activity will be pivotal to improve the food-based promotion of health and well     being. The project aims at studying how the omnivore, vegetarian and vegan diets may affect     the oral intake of microorganims, and the composition of the oral and fecal microbiota. With     the aim to build up a permanent European platform for such type of studies, ten Research     Units (RUs) are involved in the proposal, with the partnership of 16 National and,     especially, foreign Institutions, covering 12 different countries. About 50 omnivore,     vegetarian and vegan volunteers, for a total of 150 subjects will be recruited. Volunteers     will be asked to fill in diaries, describing their dietary habits, and to collect biological     samples (saliva, feces and urine), once a week for three weeks. For obvious ethical     constraints, biopsies will be not available in this study. RUs will share their tasks, mainly     depending on the nature of the samples to be studied, namely foods and biological samples.     Based on the different dietary habits, the presumptive intake of microorganims will be     estimated using literature data and, especially, culture-dependent methods. Typing and     antibiotic resistance of some food related microbial communities or foods will be also     investigated. The microbial diversity of foods, whose microbiota has never been studied in     depth, will be characterized by PCR-DGGE and deep sequencing. The metabolome characterization     will complete the overview on foods. After collecting and preparing biological samples from     the three diet groups, the oral and fecal microbiota will be studied. The viable cell number     of several microbial groups will be estimated in fecal samples, before freezing.     Preliminarily, the microbial diversity of saliva and fecal ecosystems will be analyzed     through PCR-DGGE. PCR assessment of genetic basis of antibiotic resistance will be also     carried out. Selected numbers of biological samples will be further subjected to next     generation sequencing, aiming at determining representative individuals/samples of the three     types of diet. Only for feces, representative samples (e.g., 4/5 for each diet) will be     subjected to meta-omics analyses based on meta-genomic, meta-transcriptomic and     meta-proteomic approaches. An integrated and iterative workflow will be also developed, by     assembling an in house synthetic meta-genome. The functionality of fecal samples and/or of     isolates from feces will be characterized based on fecal genotoxic and anti-genotoxic     activities, and modulation of the immune response. In agreement with an holistic approach,     the metabolome analysis of saliva, feces and urine will complete the characterization of     biological samples. All data available from the different RUs will merge into a common     database, whose structure will be developed during the project. Based on the literature data     (ISI Web of Knowledge), this is the first study that aims at correlating the effect of the     main dietary habits on the oral and fecal microbiota through integrated meta-omics analyses.   "
89175|NCT02118844|"     The purpose of this study is to determine whether deep neuromuscular blockade compared to     moderate neuromuscular blockade may improve the surgical conditions in patients undergoing     laparoscopic bariatric surgery.   "
89176|NCT02118831|"     Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the     systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on     circulating vascular endothelial growth factor. In the present prospective study, the     investigators evaluated serum drug levels and plasma free vascular endothelial growth factor     (VEGF) levels in patients with neovascular age-related macular degeneration following     intravitreal injections of ranibizumab, bevacizumab and aflibercept.   "
89177|NCT02118818|"     Rheumatic fever (RF) is an autoimmune disease that is mediated by the cellular and humoral     immune response that follows an untreated pharyngeal Streptococcus pyogenes infection. The     most serious complication is rheumatic heart disease (RHD), one of the most common problems     facing children and young adults worldwide, which leads to chronic valvular lesions. It is     estimated that 60% of all acute rheumatic fever cases will develop RHD.      The pathogenesis of RHD is complex with both environmental and genetic factors contributing     to its etiology. The investigators know little about the genetic etiology, cellular events     and modifiers of progression of RHD, and there exists a wide range of disease severity and     progression to severe valve pathology.      Thus, the investigators will study the genetics of RHD in Rwanda, a country with a very high     incidence of RHD, using a combination of next-generation targeted exome capture,     transcriptomics, and expressed quantitative trait loci (eQTL) analysis.   "
89178|NCT02118805|"     This study is evaluating the use of two painless, non-invasive technologies in the assessment     of muscle health over time in both healthy volunteers and patients who have diseases that     affect the nervous system.   "
89179|NCT02118792|"     The purpose of this study is to investigate the safety and efficacy of AN2728 Topical     Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic     dermatitis.   "
89180|NCT02118779|"     Myotonic dystrophy type1 (DM1) is a rare, inherited, chronic progressive disease as well as     an autosomal dominant multisystemic disorder. It is the most common adult form of muscular     dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733     million people in Europe, we estimate that 75,000 people are DM1 patients in Europe.      The aim of OPTIMISTIC is to improve clinical practice in the management of patients with this     rare disease for which no dedicated treatment is currently available. OPTIMISTIC is a     multi-centre, randomised controlled trial designed to compare a two component tailored     behavioural change intervention to increase physical activity against standard patient     management regimes, with particular attention given to the definition of appropriate outcome     measures and new clinical guidelines for DM1 management. The two components of the     intervention are 1) cognitive behavioural therapy (CBT) and 2) graded physical activity and     we will evaluate the intervention's effectiveness and safety against standard patient     management.      Participants will be recruited from myotonic dystrophy clinics and neuromuscular centres in     France, Germany, the Netherlands and the UK. A total of 286 male and female patients aged 18     years and older with genetically proven classical or adult DM1 suffering from severe fatigue     (only DM1 patients with a CIS subscale fatigue score > 35 are likely to benefit from the     intervention), able to walk independently and able to complete the trial interventions will     be included.      A key objective of OPTIMISTIC is to provide outcome measures that are relevant for the     patients and have a rate of change that is appropriate for a clinical trial timeframe. In     addition, OPTIMISTIC will identify genetic factors that predict outcome and potential     biomarkers as surrogate outcome measures that best explain the observed clinical variation.   "
89181|NCT02118766|"     The purpose of this study is to investigate the safety and efficacy of AN2728 Topical     Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic     dermatitis.   "
89182|NCT02118753|"     In the laboratory, the researchers will investigate whether the drug eplerenone improves     contractile function after ischemia and reperfusion in heart tissue.   "
89183|NCT02118740|"     This is a observational study in which healthy found volunteers are recruited to donate 50 ml     of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety     of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only     for animal studies and after completion of the preclinical program, the intention of AMARCELL     is to treat humans with a traumatic Spinal cord injury.   "
89184|NCT02118727|"     The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction     with riluzole, can slow down the disease progression of patients with ALS including     potentially improving their neuropsychiatric changes, as well as determine if CSF protein     biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS.      Funding Source-FDA OOPD   "
89185|NCT02118714|"     This study is being conducted to evaluate the effects of Atrasentan on sperm production and     the function of the testicles in male subjects with Type 1 or 2 Diabetes and Nephropathy.   "
89225|NCT02118194|"     The overall goal of this project is to determine if non-ambulatory persons with spinal cord     injury (SCI) who have already participated in at least 20 sessions of ReWalk training can be     further trained to achieve more advanced skills for use in the home or work place     environments and outdoor community mobility skills in the ReWalk exoskeleton.   "
89186|NCT02118701|"     Shared Decision Making (SDM) is defined as a process where healthcare professionals and     patients make decisions together, using the best available evidence. SDM, as a communication     and decision method, can be used also with persons suffering from dementia. Yet, SDM with     persons with dementia or even with their family caregivers is not widespread.      The present research project aims to develop and evaluate an SDM framework in care planning     to be implemented in long-term care facilities, in order to obtain a constantly developing     care plan that focuses not only on the medical, physical, psychosocial and spiritual needs of     the resident, but that considers and documents his preferences and the actions taken by     caregivers to meet them.      The current project is a controlled exploratory study. Case studies that involve a triad in     each case, composed by the resident with moderate or severe dementia, his family caregiver     and the professional usually taking care for the resident, will be used (n=16 professionals;     n=40 residents; n=40 family caregivers). Professional caregivers of two nursing homes, one     located in Italy and one in the Netherlands, will receive a specific training in SDM     principles and will guide the SDM interview within the triad. Primary outcome will be the     proportion of residents whose preferences and needs, together with the related actions to     meet them, are known, documented and satisfied in their 'life-and-care plans'. Secondary     outcomes are the residents' and family caregivers' quality of life; the family caregivers'     sense of competence and the healthcare professionals' job satisfaction. Semi-structured     interviews and focus group interviews will be performed to assess satisfaction with the     intervention and barriers and facilitators to its implementation. Assessments are performed     at baseline and six months after the intervention.      We hypothesize that the use of the SDM process in care planning will increase the number of     met needs and will improve the residents' and family caregivers quality of life, the family     caregivers' sense of competence and the healthcare professionals' job satisfaction.      The key element of this study is that it will contribute to our knowledge about the efficacy     and feasibility of an SDM framework in care planning in long-term care facilities with     persons with moderate to severe dementia.   "
89187|NCT02118688|"     The purpose of this randomized clinical trial is to determine whether risperidone alone,     trazodone alone, or a combination of risperidone and trazodone is superior for the treatment     of ICU acquired delirium. The hypothesis is that combination therapy is superior to either     agent alone in treating ICU acquired delirium and sustaining delirium free time.   "
89188|NCT02118675|"     The study is to collect the body composition data using five different methods-bioimpedance     analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical), deuterium dilution (heavy     water), body circumferences (tape measure, TC2), and tissue thickness by ultrasound (GE     Medical, BodyMetrix).   "
89189|NCT02118662|"     The study is designed to measure the energy expenditure associated with a common office task     (i.e., typing) while 1.) seated in an office chair, 2.) pedaling using a prototype pedal     desk, and 3.) walking on a treadmill.   "
89190|NCT02118649|"     Participants will play a computer game that is controlled by their gaze patterns and designed     to direct attention their attention to specific on-screen targets. Visual attention to     targets will be rewarded. Both visual behavior and brain response will be recorded during     game play.      It is hypothesized that that, over the course of the game, relative to baseline, participants     will show (a) increased looking to targets, (b) decreased response time to targets, and (c)     enhanced, more efficient neural response to visual cues. It is hypothesized that clinical     variability will associate with visual attention and brain response.   "
89191|NCT02118636|"     Early stage hormone receptor positive breast cancer is typically treated with adjuvant     endocrine therapy in order to decrease risk of breast cancer recurrence and to improve     overall survival from the disease. Typical agents used for treatment include tamoxifen and     the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is     increasingly common because it is associated with fewer long-term serious toxicities compared     to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which     can influence adherence to therapy and can lead to treatment discontinuation in a minority of     cases. The mechanism underlying development of this toxicity remains unclear, and predictors     of who will develop these symptoms remain undefined. This observational study is designed to     collect patient-reported outcomes and serial serum samples in order to investigate potential     etiologies of this bothersome toxicity.   "
89192|NCT02118623|"     This study will examine if there is a benefit of an online intervention for persons with     bipolar diagnoses, and what components appear to be most useful.   "
89193|NCT02118610|"     Schizophrenia is a devastating and complex illness, with multiple symptom and behavioral     manifestations. Antipsychotic medications are the mainstay of treatment; however, many     patients only partially respond to treatment. Development of new treatment has not progressed     rapidly, in part, because the underlying etiopathophysiology of the illness is not well     understood. To date, all pharmacological treatments approved for use in schizophrenia involve     primary modulation of the dopamine system. Many agents without dopamine action have failed to     demonstrate efficacy. There is growing evidence that schizophrenia may be, in part, due to an     inflammatory process and pharmacological treatment approaches that decrease inflammation have     shown promise. Thus, treatments that may have anti-inflammatory properties (e.g., TNF-alpha     inhibition), but also possess dopamine modulation may prove to be beneficial. This novel     medication, l-tetrahydropalmatine (l-THP), has robust anti-inflammatory properties,     particularly TNF-alpha and ICAM inhibition; has antiprotozoal activity; and possesses an     antipsychotic-like pharmacological profile of D1, D2 and D3 receptor antagonism. The high     affinity of l-THP for D1 versus D2 receptors distinguishes it from first generation     antipsychotics and its D1 to D2 ratio resembles that of the superior antipsychotic,     clozapine. Also, an almost identical compound, l-stepholindine (l-SPD), demonstrates robust     antipsychotic activity in humans (both positive and negative symptoms) and is currently used     clinically in China. l-THP has been used for over 40 years clinically in China, has a good     safety profile to date, and represents a novel and exciting mechanism for schizophrenia     treatment. Initial safety data from our phase I study of l-THP (20 healthy controls) shows     excellent tolerability and lack of any substantial side effects. L-THP has been tested in     outpatient drug abuse trials for 4 weeks with good safety data, (Hu et al 2006, Yang et al     2003). Yang et al (2003) randomized this medication in over 120 participants for 4 weeks with     4 week observation without any notable side effects.      We will test this compound (30 mg BID) as an adjunct treatment in a randomized, double-blind,     4-week trial, in which we will assess treatment efficacy, changes in peripheral cytokine     concentrations, and, secondarily, antiprotozoal effects, (antibody titers to Toxoplasma     gondii), an infection that is known to occur at higher rates in schizophrenia than healthy     controls and may be related in part to the illness.   "
89194|NCT02118597|"     This prospective, national, multicenter, non-interventional study examined the use of triple     combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and     ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection.     Dosing and treatment duration were at the discretion of the investigator in accordance with     local clinical practice and local labeling. Participants were to be observed for the duration     of their triple combination therapy and for up to 24 weeks thereafter.   "
89226|NCT02118181|"     The purpose of this study is to determine whether a supplementation containing     β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a     group of older women compared to a non interventional group   "
89227|NCT02118168|"     An observational study to prospectively follow-up the patients enrolled in the ISS T-002     clinical trial up to 132 weeks. The primary endpoint of this study is to evaluate the     persistence, in term of frequency, magnitude and quality, of the anti-Tat humoral and     cellular immune response in the HIV-1 infected individuals who participated to the ISS T-002     and who have received at least 3 immunizations. The secondary endpoint is to define and     validate novel laboratory tests for future efficacy clinical trials.   "
89195|NCT02118584|"     This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study     will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe     ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies.     Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927     [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429],     GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included.     Participants from the Phase II OLE study or the Phase III studies who are not eligible or     willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety     follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 7 years     after the first participant is enrolled into the study. Following Part 1, participants will     enter Part 2 for a period of 92 weeks.   "
89196|NCT02118571|"     The objective of this protocol is to develop items for a patient-reported outcome (PRO)     measure to assess the patient's perspective and subjective experience of cognitive impairment     associated with schizophrenia (CIAS).   "
89197|NCT02118558|"     This trial is a prospective, single center, unblinded, randomized, controlled study to assess     the safety and efficacy of negative pressure wound therapy in preventing infections after TKA     surgery . The study will enroll 316 patients that will undergo TKA. patients will be     randomized to the treatment group and undergo the study intervention - (NPWT) The     intervention will take place at the end of the surgery. The Patients that are randomized to     the control group will receive standard treatment. Both groups will be assessed at two weeks     and six weeks. period.   "
89198|NCT02118545|"     vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of     platelets and is released upon their activation. Endothelial cell dysfunction as well as     platelet activation often occur in liver disease and portal hypertension, which may lead to     an increase in circulating vWF levels. Indeed, multiple studies have reported that liver     disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore,     increased circulating vWF -Ag Levels have been shown to be associated with increased     mortality rates in patients with chronic liver disease. Within a prospective evaluation     cohort, the investigators were able to document that patients with increased vWF-Ag levels     prior to liver resection suffered from an increased incidence of postoperative liver     dysfunction and morbidity. Within this prospective multicenter validation study, the     investigators now aim to prospectively validate that circulating vWF-Ag prior to liver     resection is a valuable marker to predict postoperative clinical outcome.   "
89199|NCT02118532|"     The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for     the interventional treatment of new and non-stented restenotic lesions in the superficial     femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.   "
89200|NCT02118519|"     Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using     bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing     conditions.   "
89201|NCT02118506|"     The purpose of this study is to compare the effects of mental practice, associated with     physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic     Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated     with mental practice and physical practice can trigger significant changes in spatiotemporal     and angular parameters that are not observed in the group not submitted to mental practice.   "
89202|NCT02118493|"     The biliary system normally empties into the intestines, however, some patients have biliary     system narrow areas (stenosis) that prevent the bile to drain normally. These may be     related to an underlying disease or previous surgery. Patients with this problem usually     require tubes to be inserted into the biliary system to drain bile into a bag outside of     their body, impacting their quality of life.      The purpose of this research study is to use a laser device to try to re-open the biliary     drainage system.   "
89203|NCT02118480|"     The study design was a parallel-group randomized trial with equal randomization. Recruitment     and enrollment were conducted between June 2012 and January 2013. At base-line, clinical,     cognitive and functional data was collected. Afterwards, the participants were randomly     allocated to either the REHACOP group or the Control group. During 3 months the intervention     with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate     the changes in clinical, cognitive and functional measures. Post-treatment assessment     (finished by June 2013) was performed within the first week after completing the     intervention.Optional enrollment in pre- post neuroimaging will also allow us to look at     changes in the brain. Finally, longitudinal follow-up at 18 months with neuropsychological     and neuroimaging assessements was also performed.      Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to     improve cognition, clinical symptoms and functional disability of patients with Parkinson     disease (PD).   "
89204|NCT02118467|"     The investigators hypothesis is that for ICU patients with shock, the use of the vasoactive     drugs phenylephrine and vasopressin will reduce tachydysrhythmias when compared to     norepinephrine and epinephrine. To investigate this hypothesis, the investigators are     conducting a randomized double blind controlled trial comparing phenylephrine and vasopressin     vs. norepinephrine and epinephrine in ICU patients with shock that is not responsive to IV     fluids. All patients admitted to the adult intensive care units at the University of Chicago     will be screened for eligibility.   "
89205|NCT02118454|"     The purpose of this study is to test whether twice-daily Interactive Voice Response (IVR)     calls made at the estimated times of patients' antiretroviral (ART) medication dosing and     three reminder calls for monthly clinic appointments, will result in improvements in ART     adherence, appointment attendance, health indicators (CD4 cell counts), coping skills, social     support, depressive symptoms, and other quality-of-life indicators, compared to a control     group receiving one IVR assessment call each week, over six months.      This is a randomized controlled trial of the IVR intervention with n=400 PLH taking first     line ART in India on a twice-a-day dosing schedule. The research is supported by an Indo-U.S.     Bilateral review and funding collaboration between NIH and ICMR. The research is being     implemented in Kolkata by Drs. Smarajit Jana (PI, India) and Protim Ray (Project Director) at     Durbar, a community-based organization providing HIV/STD prevention and community development     programs with sex workers and other at-risk communities.      This is Phase 2 of a two-phase pilot project. Phase 1 was a one-month no-control pilot (n=46)     for feasibility, acceptability, and patient feedback on preferences for messaging content.     Phase 2 has two sites, described as Phases 2A and 2b, which will occur simultaneously and     differ only in their recruitment sites and corresponding sampling strategy (sample size,     gender ratio, eligibility criteria) based on site population characteristics.        -  Phase 2A will recruit n=80 women and n=20 men from Durbar's Mamata Care and Treatment          Center (MCTC) (providing HIV testing and treatment linkage and support) and associated          Mamata Network of Positive Women (MNPW), which focus on HIV+ sex workers and their male          partners and networks.        -  Phase 2B will recruit n=100 women and n=200 men from the ART Centre at the Calcutta          School of Tropical Medicine (STM), which hosts the largest ART center in the Northeast          Region of India and has over 3,000 active patients on first line ART.      The sampling plan reflects the gender distribution of clients and patients at the two sites.      Participants will be randomized within each site and gender sub-sample to receive:        -  The IVR Intervention: consisting of two (2) automated voice calls (intervention          messages) each day for six months, PLUS one IVR assessment call (consisting of four [4]          questions) every week for 6 months; OR,        -  The Control Condition: consisting of standard care, PLUS one IVR assessment call          (consisting of four [4] questions) every week for 6 months.      All participants will be interviewed in-person by a research team member at baseline and     followed-up at 2- 4- and 6-months using structured questionnaires and recording information     from the participant's personal medical record (i.e., their ART Card) to assess background     characteristics and intervention impacts on ART adherence, health quality-of-life (i.e.,     depressive symptoms, social support). All participants will receive one IVR assessment phone     call (consisting of four (4) questions during each week of the 6 month study. Each     once-a-week IVR assessment will ask about missed medication and the participant's     health/quality of life, and participants will respond by keying in a 1 (yes) or 2 (no) on     their mobile phone.   "
89206|NCT02118441|"     When a patient undergoes heart surgery, their Anesthesiologist will insert a tiny plastic     tube, called a catheter, in the artery of the patient's wrist. This is called a radial artery     catheter. A radial artery catheter allows accurate measurement of the patient's blood     pressure during surgery. There are two common techniques for placing the radial artery     catheter. The first is a blind technique whereby the Anesthesiologist feels for the pulse     in the patient's wrist and places the catheter using the location of the pulse as a guide.     The second technique, less commonly used, is one whereby the Anesthesiologist uses an     ultrasound machine (painless to the patient) to see the artery, and thereby uses the     ultrasound to guide the catheter placement. Our study will test the hypothesis that     ultrasound-guided radial artery catheterization will have faster insertion times, with fewer     complications compared with palpation-guided insertion.   "
89209|NCT02118402|"     Iron deficiency and anemia are health issues affecting mainly infants and women in developing     countries. Iron deficiency in infancy can have long-lasting impact on cognitive and motor     development of the child. Iron fortification has shown to be effective against anemia.     However, in areas with a high burden of infectious diseases iron may increase the risk of     unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Therefore we     want to assess the effects of home fortification of complementary food with two     iron-containing micronutrient powders (MNPs) with and without the addition of a prebiotic     (7.5 g of galactooligosaccharides as GOS-75) compared to a control on the composition of the     gut microbiota of Kenyan infants. In this study we will use an MNP with a moderate iron dose     of 5 mg, with 2.5 mg of Fe as NaFeEDTA and 2.5 mg of Fe as ferrous fumarate (+Fe). There will     be 3 study groups MNP, MNP+Fe and MNP+Fe+GOS. The infants will be enrolled in the study at     the age of 6-10 months and will consume a home-fortified maize porridge for four months. At     baseline and endpoint (after 4 months of intervention), we will collect blood samples of the     infants in order to assess anemia, iron status, and inflammation. Fecal samples (from child     and mother) will be collected at baseline, 3 weeks and at endpoint in order to evaluate the     changes in gut microbiota and gut inflammation.      During the intervention, in a sub-group of children who receive broad-spectrum antibiotics,     we will compare how the three different interventions modify the effect of antibiotics on the     infant gut microbiota. We will opportunistically select children that are enrolled in the     study and who become ill, and who are prescribed antibiotics by the local health care team,     according to the local standard of care in the study area. Five additional stool samples from     these children will be collected (day 0 (before the first antibiotic dose), 5, 10, 20 and 40)     to evaluate the changes in the gut microbiota and gut inflammation.   "
89210|NCT02118389|"     Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood     pressure   "
89211|NCT02118376|"     GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes,     reduce liver fat content, improve the inflammation state   "
89212|NCT02118363|"     Clinical assessment and monitoring of balance and arm function in stroke patients with sensor     based measurement, in clinical and home environment.   "
89213|NCT02118350|"     The study aimed to evaluate the chronic effects of Mat Pilates Training on blood pressure,     heart rate, double product and psychobiological factors in hypertensive medicated women and     acute effects of Mat Pilates Exercise on blood pressure of such individuals.   "
89214|NCT02118337|"     To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with     Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies.   "
89215|NCT02118324|"     This is a pilot feasibility study to collect preliminary data for a large-scale exergaming     intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia     (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention     control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a     week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology     graduate students for safety and compliance. Physical activity at baseline and at the end of     study will be assessed using accelerometers. Outcome measures will include: anthropometrics,     blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting     glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance,     and strength.   "
89216|NCT02118311|"     This is a Simon's optimal two-stage phase II trial designed to estimate grade II-IV acute     graft-versus-host disease (GVHD) after infusion of T regulatory (nTreg) in a fixed dose ratio     to the combined CD3+ cell count of the two graft units in recipients of double UCB     transplantation. The nTreg cells (manufactured from a 3rd cord blood unit) are infused on day     0 at least 1 hour after the 2nd unit of the double umbilical cord blood (UCB) transplant.      The nTreg cells require an 18 day (±2 days) lead time based on the planned transplant day.     The combined CD3+ cell content from the two graft UCB units is enumerated upon thaw (day 0).     The patient then receives the number of nTregs cells from the 3rd cord product to achieve a     Treg:CD3+ cells ratio of 5:1. The nTreg cell dose depends on the CD3+ cell content of the two     graft UCB graft units, but it will not exceed the highest dose level safely tested in the     ongoing University of Minnesota phase I Treg dose escalation study MT 2006-01.   "
89217|NCT02118298|"     The goals of this study are to 1. Investigate the sensitivity of allocentric visual memory     when compared to more established measures of cognition in identifying cognitive difficulties     among MS subjects when compared to controls. 2. Determine which cognitive test variable will     be most strongly associated with self and informant reports of cognition. 3. Determine which     MRI metric will be most strongly related to neuropsychological test performance 4. Determine     the degree to which allocentric visual memory is related to functional connectivity on fMRI.   "
89218|NCT02118285|"     This is a single center phase I trial designed to determine the maximum tolerated dose (MTD)     of the oral IDO inhibitor INCB024360 when administered as part of a larger regimen of     intraperitoneal (IP) delivery of haploidentical donor NK cells and IL-2 after a     non-myeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen for the treatment     of recurrent ovarian, fallopian tube, and primary peritoneal cancer.   "
89219|NCT02118272|"     The aim of this study is to assess the clinical, radiographic and patient-reported outcome     measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the     implants and identify possible risk factors that may lead to failure.   "
89220|NCT02118259|"     The main objective of the study is to show that the multidisciplinary review of drug     prescriptions changes the adverse drug event (ADE) geriatric risk score (according to     Trivalle and Ducimetière 2013) for patients living in the Nîmes University Hospital Residence     for Dependent Elderly.   "
89221|NCT02118246|"     Patellofemoral Pain Syndrome(PFPS) is one of the most common health-related complaints in     today's societies. Myofascial pain syndrome(MPS) have been attributed as the main cause and     primary source of musculoskeletal pain. Trigger point of the vastus lateralis muscle may pull     the patella superiorly and laterally, increasing compression of the patellofemoral joint     during physical activities, result in PFPS and anterior knee pain. The purpose of this study     was to investigate the effects of Dry Needling & kinesio tape on trigger point of vastus     lateralis muscle in PFPS subjects.   "
89222|NCT02118233|"     The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous     carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or     worsening of thinking or memory. There have been many studies on this subject, some finding     that certain patients gain improvement in their brain function and others might get worse.     The goal of this study is to discover which patients are more likely to have improved     cognitive functioning. Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and     stenting (CAS) are not investigational and are an accepted treatment for your condition. In     addition, subjects that choose not to undergo surgery will also be included in this study.   "
89231|NCT02118116|"     Gatekeeper training is where people in the community are trained to recognize and identify     those who are at risk for suicide and assist them in getting care. Gatekeeper training has     been widely implemented around the world. There are two types of gatekeepers: 1) Designated     gatekeepers - individuals who have been trained in helping professions (medicine, psychology,     social work, nursing), and 2) Emergent gatekeepers - individuals who are not in caregiving     roles (family members, police, teachers, clergy). Applied Suicide Intervention Skills     Training (ASIST) has been implemented in Manitoba. However, a recent randomized controlled     trial in First Nations community members (emergent gatekeepers) from the Swampy Cree Tribal     Council (Northwestern Manitoba) demonstrated that the training had no positive impact on     self-reported gatekeeper skills or behavior. Also, compared to a resilience retreat, the     ASIST training was associated with a slightly higher likelihood of reporting suicidal     ideation. The demonstrated lack of efficacy and the possibility of adverse effects associated     with this training program in this vulnerable group have raised concerns about the safety and     efficacy of ASIST. There were several key limitations of the previous study. First, the study     only recruited community members (emergent gatekeepers), therefore findings may not be     generalizable to designated gatekeepers (clinicians, nurses, counselors). Second, the study     had a small sample size (n=55) and may have not been large enough to detect small effects     that are often associated with educational interventions. Finally, the increase in distress     in the ASIST trained group may not have been directly related to the training. To overcome     the above limitations, we aim to conduct a larger evaluation of the safety and effectiveness     of gatekeeper training that is occurring in Manitoba First Nations, Inuit and Metis     communities. Based on previous work that suggests designated gatekeepers are more likely to     benefit from gatekeeper training than emergent gatekeepers, we will examine these groups     separately.      Hypotheses: 1) ASIST will be associated with an increase in gatekeeper skills and behaviors;     2) ASIST will have a stronger impact on designated gatekeepers than emergent gatekeepers; 3)     ASIST will not be associated with an increase in suicidal ideation or distress.   "
89232|NCT02118103|"     The objectives of the proposed research are to quantify the impact on motor performance of a     single SM intervention on surgical waitlist patients with degenerative Lumbar Spinal Stenosis     (LSS) using a recently established lower extremity movement task: 1) using alterable levels     of task difficulty that is resistant to learning and 2) using measurement of movement     kinematics.   "
89233|NCT02118090|"     The investigators propose to leverage the unique infrastructures and expertise of National     Centre for Parasitology Entomology and Malaria Control and the Pasteur Institute in Cambodia     and combine modern fieldwork, including a mobile laboratory fully equipped for molecular     biology and culture experiments, with state-of-the-art genomic analyses to investigate how     Plasmodium vivax parasites respond to antimalarial drugs. The investigators will focus on     resistance to CQ, the choice treatment for vivax malaria in most endemic countries, for which     treatment failures have been reported in Cambodia. The study will address some of the key     biological mechanisms limiting the efficiency of drug therapy in P. vivax, including the     identification of genetic polymorphisms underlying drug resistance in Cambodian P. vivax. The     findings will provide a first unbiased perspective on the mechanisms of drug resistance in P.     vivax and have the strong potential to significantly improve malaria control in Southeast     Asia.   "
89234|NCT02118077|"     Compare the effect of G17DT with that of placebo on the survival of subjects with advanced     pancreatic cancer.   "
89235|NCT02118064|"     This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in     patients with refractory colon cancer who had been previously treated with an     Irinotecan-based chemotherapy.   "
89236|NCT02118051|"     Patients who have had or are expected to have a poor ovarian response (POR), because they     meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of     alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro     fertilization (IVF).      In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus     daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first     seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH)     antagonists   "
89237|NCT02118038|"     To assess the impact and to identify the main risk factors for psychological and cardiac     morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum     hemorrhage   "
89238|NCT02118025|"     The investigators aimed to evaluate the clinical results and the inflammatory response of the     minimal extracorporeal circulation system (MECC) Compared with off-pump coronary     revascularization (OPCABG).      This is a randomized and prospective study in 230 patients with indications for coronary     surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were     the clinical and biochemical results, intra-operative outcomes and the determination of 19     inflammatory circulating markers, 17 of them for the first time analyzed comparing both     techniques.   "
89239|NCT02118012|"     Background:      - Hepatitis C is a liver disease caused by the hepatitis C virus. It is the most common cause     of serious liver disease in the United States. Many people have few if any symptoms. It can     lead to cirrhosis, which can cause liver failure and cancer. Researchers want to study how a     medicine called chlorcyclizine works in patients with hepatitis C. They want to see if it can     be used to treat hepatitis C alone or when used with the standard hepatitis C treatment drug     ribavirin.      Objectives:      - To see if chlorcyclizine can be used to treat hepatitis C alone or in combination with the     drug ribavirin.      Eligibility:      - Adults with chronic hepatitis C who either have never been treated for it or have relapsed     after prior treatment.      Design:        -  Participants will be screened with medical history, physical exam, blood and urine          tests, and a questionnaire. They will also have an ultrasound of their abdomen and          electrocardiogram. Some of these tests will be repeated throughout the study.        -  Participants will spend 3 days as an inpatient to be monitored while starting study          drug. They will be assigned randomly to a group and will begin taking the study drug.          Blood will be taken frequently.        -  Group I will take the study drug twice a day for 28 days.        -  Group II will take the study drug twice a day and ribavirin twice a day for 28 days.        -  Participants will visit the clinic every 7 days for 28 days.        -  After participants stop taking the study drug, they will have 5 follow-up visits over 3          months.   "
89240|NCT02117999|"     The purpose of the present Randomized Clinical Trial (RCT) is to compare the efficacy and     safety of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) to treat     progressive keratoconus in comparison with standard cross-linking (standard CL).   "
89241|NCT02117986|"     The study hypothesis is that the loading dose of intravenous colistin (6 million of     international units) is associated with greater clinical and microbiological efficacy, and     reduced mortality of critically ill patients infected by multidrug resistant Gram- negative     bacilli, compared to a scheme without loading dose.   "
89242|NCT02117973|"     The purpose of this prospective randomized study is to evaluate iAssist with respect to     radiographic, clinical and economic outcomes in comparison to conventional instrumentation in     primary total knee arthroplasty using the Persona knee system among patients with BMI>=30.   "
89244|NCT02117947|"     The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in     a high risk, medically underserved population of maternal smokers. The program is called     Philadelphia FRESH (Family Rules for Establishing Smokefree Homes). Participants are     recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After     determining study eligibility via telephone screen, all participants complete an in-home     pre-intervention interview that includes self-reported smoking history, current smoking and     exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms,     weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a     biomarker used to detect SHSe).      Participants are randomized after baseline to receive either (a) a moderately intensive (up     to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered     over a 16-week period by counselors trained and supervised by investigators, or (b) an     enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for     SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of     intervention process, factors associated with intervention effects, and intervention outcomes     that include child urine cotinine (to measure level of SHSe) and participant saliva cotinine     (to verify self-reported smoking quit status). Interviewers and data management staff remain     blind to the treatment assignment. All procedures are implemented after signed informed     consent and were approved by Temple University's Institutional Review Board.   "
89246|NCT02117921|"     To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients     suffering from chronic pain syndromes without organic etiology.   "
89247|NCT02117908|"     The project aims to study whether the application of a continuous positive airway pressure     (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF)     lung cancer under conscious sedation compared with placebo. And, assess whether CPAP prevents     atelectasis formation and consequently reduces the potential complications of PRF and     improves procedural success   "
89248|NCT02117895|"     This is a prospective study of left celiac plexus resection for pancreatic cancer at the body     and tail during standard distal pancreatectomy.   "
89249|NCT02117882|"     It is assumed that the minimally invasive lateral approach and the traditional lateral sinus     lift procedure will result in better outcomes in terms of height of augmented bone.      It is also assumed that the minimally invasive lateral approach will reduce surgical     complications and patient's discomfort in comparison with a traditional lateral sinus lift     procedure.   "
89250|NCT02117869|"     Grapefruit (GF) contains furanocoumarin (FC) which is known to irreversibly inhibit the     activity of cytochrome P450-3A (CYP3A) enzymes in the human gastrointestinal tract (PAINE     2005). Because CYP3A enzymes are integral in the metabolism of some drugs, co-ingesting GF or     GF Juice (GFJ), which inhibits CYP3A, along with drugs reliant on CYP3A for metabolism can     significantly alter the drugs kinetic properties and result in elevated plasma drug     concentrations which may be toxic. The Citrus Research and Education Center at the University     of Florida has developed a new GF hybrid (GFH) which contains low FC content and which may     not inhibit CYP3A enzyme activity, and therefore may be safe to co-ingest with drugs that     require CYP3A activity for metabolism. The investigators hypothesize that low FC GFHJ will     not inhibit CYP3A to the degree that regular GFJ does, and will not significantly affect     midazolam kinetics compared with regular GFJ. Midazolam is an FDA approved probe drug for     CYP3A activity and has been used previously to establish an interaction between GFJ and     midazolam. This study will evaluate the concomitant administration of midazolam and low FC     GFHJ, regular GFJ, or water to evaluate the significance of this interaction.   "
89251|NCT02117856|"     This study is a randomized clinical trial to compare patient satisfaction and prosthetic     outcomes with lower dentures retained by one or two implants. The investigators long-term     objective is to establish evidence of the cost-effectiveness of a single implant intervention     for improving tolerance to complete dentures. The investigators MAIN AIM will be to     investigate patient satisfaction between and within groups with mandibular dentures retained     by one or two implants over five years, and SECONDARILY to investigate the survival of     implants, and the frequency of events to maintain the dentures and prosthetic attachments as     clinically serviceable. Furthermore, multivariate analysis can assess the prediction of     patient satisfaction with implant dentures based on various possible factors including age,     health, demography and socioeconomic status, number of implants, and maintenance needs.     Patient satisfaction will be measured by means of Visual Analogue Scales (VAS) including a     measure of overall satisfaction and various specific aspects of satisfaction such as     appearance, stability and comfort of the dentures.      The CENTRAL HYPOTHESIS is that mandibular complete dentures retained by single implants are     at least as satisfying to patients over a five years period as those retained by two implants     for the same period.      The SECONDARY HYPOTHESES are that:      i) there is no difference over five years between groups in the survival of original     implants, or in the number of events for maintenance of the dentures or implant attachments;     and ii) using each treatment group as it's own control, there is no change in patient     satisfaction with lower dentures retained by either one or two implants during the five year     loading period.   "
89252|NCT02117843|"     The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and     Efficacy of 'AVI' Stent for Treating Coronary Revascularization.   "
89253|NCT02117830|"     This is a Phase I, single-site, randomized, double-blinded, double-dummy, placebo- and     positive-controlled, 4-period crossover study to evaluate the effect of two dose levels of     Androxal on cardiac repolarization. Baseline ECGs will be obtained prior to dosing in each     Period and ECGs will be obtained during expected peak plasma concentrations of Androxal and     the positive control.      In each Treatment Period subjects will be admitted to a Clinical Research Unit where study     drug will be administered as three (3) daily single doses. Treatment Periods will be     separated by a washout of at least 7 days between Periods.   "
89293|NCT02117297|"     Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab     Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.   "
89309|NCT02117089|"     The purpose of this study is to investigate the combined training effectiveness of mechanical     robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.   "
89310|NCT02117076|"     The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin)     versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.   "
89254|NCT02117817|"     The purpose of the first part of this study or the dose escalation portion of the study is to     determine what dose of BKM120 and Abraxane is safe to give when the two drugs are used at the     same time in patients who are diagnosed with a solid cancer. A solid cancer is a cancer that     does not involve the blood, bone marrow or lymph nodes. Dose escalation determines the least     toxic and most effect dose of this drug combination for treatment. Once this dose is     established, it will be used for the dose expansion phase of the study where we will     determine the effect of BKM120 and Abraxane in women diagnosed with a recurrent endometrial     or ovarian cancer. We will see whether the combination of both drugs improves the response     and survival of patients treated on the two drug regimen. Also we will try to find out     whether there are changes in tumors that can help us determine what patients are more likely     to respond to BKM120 and Abraxane.   "
89255|NCT02117804|"     The purpose of this study is to determine the predictive performance of the Early Screen for     Discharge Planning (ESDP) tool in a regional community hospital. The central hypothesis is     that the ESDP differentiates between patients in a regional community hospital who would     benefit from those who would not benefit from early discharge-planning intervention as     measured by problems and unmet continuing care needs, quality of life, length of stay, and     referrals to post-acute services.   "
89256|NCT02117791|"     This local, prospective, non-interventional, multi-center study includes patients treated     with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/     persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of     400 patients (valid for safety analysis). This study is performed as an all-case     investigation. The treatment of Riociguat is performed based on the product label in Japan.     The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and     effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is     carried out once a year for 7 years at the longest to collect information on safety and     effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is     terminated, observation of a patient ends. For each patient, the investigator records data as     defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC)     system. The duration of the study is approximately 9 years from launch.   "
89257|NCT02117778|"     This study is designed to evaluate lung function and pain control of continuous     supraclavicular versus suprascapular versus interscalene nerve catheters in subjects     undergoing total shoulder replacement. The investigators hypothesize that all three groups     would have similar pain control; the supraclavicular and suprascapular groups may have better     lung function.   "
89258|NCT02117765|"     In type 1 diabetes (T1D), immune defense cells in the body attack and destroy     insulin-producing beta cells leaving affected people with a lifelong need for daily insulin     injections. Even with insulin injections, blood glucose (sugar) control is imperfect and     leads to many health complications and a shortened life span. This is a pilot clinical trial     to test the safety of a drug, ustekinumab, in 20 adult subjects with recent-onset T1D.     Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly     effective and safe and so the investigators hope to see a similar effect in T1D. This trial     will also be used to determine the best dosage and frequency of the drug to be given to     people with T1D to help design future studies on the drug's effectiveness. The investigators     hope that if the drug can block immune cells soon after the development of diabetes, any     remaining insulin-producing cells may be protected, and regenerate, thus producing more     insulin so that individuals may be insulin free, or require less insulin.   "
89259|NCT02117752|"     This study will determine the cumulative irritation potential and sensitization potential of     dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.   "
89260|NCT02117739|"     This study will evaluate the potential of dapsone gel and its vehicle to cause a     photoallergic reaction after repeated application and irradiation to the skin of healthy     volunteers under controlled conditions.   "
89261|NCT02117726|"     Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol,     midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been     reported to be used together with midazolam in ICU and the combination of propofol and     midazolam is most commonly used, but things follow include a high incidence rate of delirium,     But the combination of midazolam and dexmedetomidine may have complementary advantages and     could have be a better choice for sedation. In this study, we attempted to observe the     effects of two different drug regimens on delirium incidence rates in severe ARDS patients' :     midazolam and propofol vs propofol and dexmedetomidine .   "
89262|NCT02117713|"     This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome     who have completed participation in a core LUM001 treatment protocol. The primary objective     is to evaluate long-term safety and tolerability of LUM001. Efficacy will be assessed by     evaluating the effect of LUM001 on the biochemical markers and pruritus associated with     Alagille Syndrome.   "
89263|NCT02117700|"     Although weight reduction through physical activity-based interventions is the mainstay     therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and     typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies.     Although convincing data from animal studies and a few adult human studies on the benefits of     a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions including NAFLD     have emerged, studies in children are scarce. Therefore, the aim of the study is to test the     use NAC as an innovative approach to attenuate the progression of NAFD in obese children with     biopsy proven NASH. The central hypothesis is that NAC supplementation will reduce liver fat     and liver enzymes and ameliorate risk factors of cardiometabolic disease in children with     NAFLD.   "
89264|NCT02117687|"     This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi     for the management of dry eye.   "
89265|NCT02117674|"     The aim of this study is to evaluate FUSE-colonoscopy in terms of feasibility and its     possible additive contribution in the detection of important lesions, namely polyps and     cancers, compared to the standard forward-viewing approach, with and without the addition     of the right-colon retroflexion technique, in a series of patients undergoing back-to-back     screening or surveillance colonoscopies in a randomized fashion.   "
89266|NCT02117661|"     Obesity is one of the main causes of the metabolic syndrome, a condition which is becoming     more common in Canada and worldwide. Metabolic syndrome is a name for a group of heart     disease risk factors that occur together: obesity, diabetes, high blood pressure, and high     cholesterol. These patients have a high risk of developing narrowing and blockages of blood     vessels which occur when fat and cholesterol build up in the walls of blood vessels and form     plaque. This is called atherosclerosis. Plaque buildup leads to stroke, heart attacks, and     death. We do not understand the underlying mechanisms of the metabolic syndrome and we do not     have a treatment for it. L-carnitine, a dietary supplement, has been shown to treat some     components of the metabolic syndrome, but its benefit to reduce plaque in the blood vessels     has never been studied. Recently there has been some controversy because a new study showed     that L-carnitine could make heart disease worse in some patients. Our goal is to study     whether supplementation with L-carnitine does in fact prevent or reduce buildup of plaque in     blood vessels of patients with the metabolic syndrome. This novel therapy has the potential     to decrease the burden of heart disease in obese and diabetic patients with the metabolic     syndrome.   "
89267|NCT02117648|"     The purpose of this study is to assess how the body handles LY2835219 when it is given with     another drug called clarithromycin. The study doctor will measure the amount of LY2835219     that is absorbed into the blood stream and the time that it takes to remove LY2835219 from     the body. The safety and tolerability of these drugs will be studied.      Each participant will complete 2 study periods in fixed order. After screening, Period 1 will     last approximately 8 days and Period 2 will last approximately 15 days. Participants who     complete Period 2 may continue to receive LY2835219 in 28-day cycles until discontinuation     criteria are met.   "
89269|NCT02117622|"     This study is conducted in Asia. The aim of the study is to evaluate long term safety and     efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine     clinical practice in India.   "
89270|NCT02117609|"     The objective of this study is to determine whether a supplementation with a new high-protein     oral supplement can improve the evolution of functional parameters in elderly patients in     nursing homes.   "
89271|NCT02117596|"     Damage and scarring of a transplanted kidney has become the most common cause of loss of the     transplanted kidney. This kidney damage is a complex process caused by many factors including     injury during obtaining and transplanting the kidney, injury from the immune system, injury     from infections, and injury from drugs used to stop rejection. This injury leads to scars     that decrease the kidney's ability to function properly, and over time the kidney is lost.     Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when     used over time it has been shown to cause chronic damage and scarring in the transplanted     kidney.      The purpose of this experimental study is to determine whether children can safely be     withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent     research studies in adult transplantation have demonstrated that with the use of Rapamycin®     (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase     in rejection, with decreased scarring in the kidney, and with improvements in kidney function     and survival of the kidney. A total of 50 children will enroll in this study at university     centers around the country. This study will last about 3 years.   "
89272|NCT02117583|"     To estimate the effect of food on the pharmacokinetics and relative bioavailability of     oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K     taken whole or after chewing in healthy volunteers. We have described below the two cohorts     each with two arms in this crossover study by listing them as four Arms/Groups in order to     capture the differences between the cohorts prior to the crossover and after the crossover.     14 participants are planned for the first cohort and 18 participants are planned for the     second cohort.   "
89273|NCT02117570|"     This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85     years, who will each receive 3 doses of vaccine. The study will assess the safety and     tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.   "
89274|NCT02117557|"     -  Compared with traditional open colectomy, laparoscopic surgery is associated with less          pain, earlier recovery, and better cosmetic outcome, and its short- and long-term          oncologic outcomes have been demonstrated.        -  In experienced surgeons' hands, single incision laparoscopic surgery is increasingly          performed for colorectal disease, and even for malignant lesion because of its reduced          incision-associated morbidity and scarring.        -  However, the safety and efficacy of single incision laparoscopic surgery for colorectal          cancer has not yet been evaluated. Thus, the prospective randomized trial comparing          single incision versus conventional laparoscopic surgery for colorectal cancer is          needed.   "
89275|NCT02117544|"     The purpose of this study is to evaluate the visual performance of a new multifocal High ADD     contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD     Contact Lens.   "
89294|NCT02117284|"     Rubidium is a newly approved nuclear medicine imaging drug or 'tracer' used to look at blood     flow in the heart. This tracer is given using a special pump called an 'elution system' which     is considered investigational. This means the device is not yet approved by Health Canada for     general use, but it has been approved for use in this study. It has been used routinely in     this hospital since 2010.      The purpose of this study is to confirm proper operation of the pump. It may also help     identify areas for future improvement. The study data may be used for safety reporting to the     Ministry of Health or to Health Canada. The study will enroll 2,400 patients in 6 hospitals     across Canada. The University of Ottawa Heart Institute (UOHI) will enroll up to 1,200     patients.   "
89340|NCT02116686|"     The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart     failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal     cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or     adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases     remains undiagnosed and untreated especially due to cost and time delay for polysomnography     examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are     developed. Some methods, based on nocturnal ECG analysis showed promising results but they     are not validated and adapted for cardiac population. Thus, the goal of present study is to     test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.   "
89276|NCT02117518|"     It is well established that CD8 and CD4 T cells reactive against defined islet antigens are     associated with initiation and progression of Type 1 Diabetes (T1D). In previous work, we     have demonstrated that it is possible to redirect T cells against pathogenic T cells via     chimeric peptide/MHC/CD3-zeta receptors in a peptide-specific manner and to prevent, or     inhibit diabetes in NOD mice. In this study we intend to extend this approach to T cells of     T1D patients. Working hypothesis: Beta cell-reactive CD8 T cells of human T1D patients can be     immuno-targeted by their own gene-modified cytotoxic T lymphocytes (CTLs). Aims: Our major     aim is to demonstrate, in a set of ex-vivo experiments, such immunotargeting with T cells     derived from T1D patients at the Ziv Medical Center. To this end we will stimulate and expand     autoreactive CD8 cells in blood samples of T1D patients and target them, ex-vivo, with     genetically-reprogrammed CTLs which are present in the same blood samples.   "
89277|NCT02117505|"     The purpose of this study is to evaluate the relative bioavailability (the extent to which a     drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test)     compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed     conditions at a single dose of 150 milligram (mg).   "
89278|NCT02117492|"     The purpose of this study is to evaluate the possible impacts of two techniques of vaginal     cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal     cuff closure and the impact that these techniques have on vaginal length, sexual function,     and overall complication rates.   "
89279|NCT02117479|"     Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine     for the treatment of advanced or metastatic pancreatic cancer.   "
89280|NCT02117466|"     In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in     extra-hepatic colorectal metastases. The investigators hypothesize that uptake of     89Zr-cetuximab is required for response to cetuximab. If no uptake is present the     investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET.      The investigators will evaluate the clinical benefit rate of cetuximab in the patients with     and without uptake. The ultimate goal is to create a selection tool that can predict response     of cetuximab.   "
89281|NCT02117453|"     The purpose of this study is to assess whether rosuvastatin could reduce the subclinical     markers of atherosclerosis and the incidence of major cardiovascular events in patients with     primary necrotizing vasculitides.   "
89282|NCT02117440|"     This study is designed to apply functional imaging, Fluorodeoxyglucose_Positron Emission     Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography     (V/Q SPECT), before treatment and then again during treatment to see if it predicts how well     the treatment works for your cancer and how well your lungs function during treatment. A     Computerized Tomography (CT) will also be performed along with both of these procedures to     help the researchers see clearly where your cancer or your healthy lung is located. The     researchers also perform blood tests in this study to look for markers in your blood to see     if it helps them determine your risk of developing side effects from radiation to the lungs.     The researchers hope that this study will help them in the future to design radiation     treatment plans that provide the best treatment for each individual patient.   "
89283|NCT02117427|"     The objectives of this study are to assess safety and to evaluate the biologic activity of     TARGTEPO treatment.   "
89284|NCT02117414|"     The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD     (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance     Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI     scans may occur anywhere on the body).   "
89285|NCT02117401|"     To evaluate the effect and safety of mivacurium chloride in pediatric patients.   "
89286|NCT02117388|"     The purpose of this study is to evaluate the relative efficacy and effectiveness of specific     components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and     cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).   "
89287|NCT02117375|"     The purpose of this study is to evaluate the prognostic value of early focal lesions and     early diffuse lesions on ambulatory disability progression within 5 years after clinical     onset.   "
89288|NCT02117362|"     The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the     FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is     a galectin. Galectins are a family of proteins that have numerous functions in normal     mammalian biology including the facilitation of cell-cell interactions, regulation of     cell-death and regulation of immune system responses. The hypothesis is that a safe dose of     GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.   "
89289|NCT02117349|"     The purpose of the study is to show that Raplixa plus gelatin sponge is better than gelatin     sponge alone in stopping mild to moderate bleeding in children having surgery   "
89290|NCT02117336|"     This is an open-label, Phase I/Ib trial with a dose escalation phase, followed by a dose     extension phase. The objective of the dose escalation phase is to evaluate the     pharmacokinetics (PK) and MTD of P1446A-05 in relapsed/refractory CLL and the objective of     the dose extension phase is to evaluate the safety, efficacy and pharmacodynamics of     P1446A-05 in 14 patients at the MTD level.   "
89291|NCT02117323|"     A prospective observational study on corneal opacities in infants and children (1 month to 18     years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal     opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis.     Sixty (60) subjects will be recruited. The children will be examined under anesthesia with a     portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an operating     microscope-style mount at CHLA will be used for the intraoperative scans. Both     cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map,     endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The     anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth,     trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or     posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence of     cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if     indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will be     measured with a tonopen (Reichert).   "
89295|NCT02117271|"     The investigators hypothesized that the treatment of obstructive sleep apnea (OSA) with     continuous positive airway pressure (CPAP) will positively affect the appearance of the     patient. The purpose of this study was to compare effects of one month of treatment of CPAP     and placebo on appearance of patient with OSA in a randomized and crossover study.      Consecutive sleepy patients with severe OSA were included. The patients underwent three     polysomnograms (PSG): first one to confirm OSA and two additional ones using placebo (nasal     dilator) and for CPAP titration before starting each treatment period. All patients were     randomly included into two treatment groups: 1) placebo use and 2) CPAP use. After one month     with the first treatment and 15 days of washout, patients were crossed-over for the second     treatment. Photographs from the patients' faces were obtained in the three experimental     moments. The photographs were presented in a random order by the Qualtrics Survey Software,     and were evaluated online by 704 observers for quantifying healthy appearance (unhealthy to     extremely healthy), attractive (unattractive to extremely attractive) and tired (not tired to     extremely tired). Apparent age was also rated for each observer. Quantitative evaluations of     the skin characteristics of the patients' faces were also carried out at each experimental     moment, including the presence of acne, patches, porosity, wrinkles, texture, and skin tone     uniformity, through the capture of images by VISIATM System equipment.      During treatment period, the 30 patients (age = 46±9 years, 21 men) wearing placebo     intervention on 98% of the nights and adherence to CPAP was 94%, with a mean of 6.0 ± 1.7     hours of use per day of treatment. Observational assessment of the photographs showed that     patients were evaluated as being younger after using CPAP (P <0.001), but no quantitative     changes in face skin characteristics were observed compared to the baseline and after the use     of placebo.      Sleepy patients with severe OSA had a younger appearance after one month of CPAP treatment.   "
89296|NCT02117258|"     The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM     plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic     Adenocarcinoma.   "
89297|NCT02117245|"     The objective of this study is to assess the bioavailability of the MGCD265 formulation     following oral administration under fed conditions (Treatment-1) as compared to fasting     conditions (Treatment-2) in healthy male and female volunteers.   "
89298|NCT02117232|"     Colonoscopy has become the gold standard in detection of colonic polyps and colon cancer.     However, colonoscopy causes significant abdominal discomfort and abdominal pain during and     after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and     pain are mostly caused by air insufflation and intubation difficulties during advancement of     the colonoscope in order the reach the cecum.      Study Hypothesis: Use of the Visualization Balloon will facilitate advancement of the     colonoscope and will eliminate the need for colonic distention with the air or CO2, which can     shortened the length of the procedure, reduce patient's discomfort and can decrease amount of     sedatives and analgesics used during colonoscopy.   "
89299|NCT02117219|"     This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity     of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in     Subjects with myelodysplastic syndrome after treatment with hypomethylating agents   "
89300|NCT02117206|"     The symptoms and severity of arterial disease is secondary to perfusion deficit. The specific     alteration of the mitochondrial function of ischemic skeletal muscle plays an important role,     and therapeutic enhancing mitochondrial function are associated with a clinical improvement     with increase in the walking distance of the patient.      In severe ischemia, reperfusion required is accompanied by a deleterious episode through a     worsening of endothelial dysfunction (impaired pathway of nitric oxide (NO)), majorant     alteration of cellular energy and the hormonal and inflammatory responses. This is     reperfusion syndrome, which can lead to grave consequences. Our goal is to limit     mitochondrial and endothelial dysfunction (increased by the reperfusion) by stimulating the     NO pathway by in situ addition of its precursor, L-arginine. Our working hypothesis is that     this cellular improvement will be accompanied by an increase in systolic pressure index and     an improvement in the walking distance.      Method: This is a trial with direct individual benefit, comparative, randomized, prospective,     single-center, double-blind, versus placebo.   "
89301|NCT02117193|"     Although the effects of acute alcohol intake and sleep deprivation on exercise performance     lacks evidence in the literature, in many situations, they occur simultaneously. Once the     alcohol affects physiological processes, the processes that occur during sleep can be     impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators     in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM     sleep. These changes promote a significant functional impairment such as a reduction in     alertness and modification in reaction time, which affects the performance of any activity of     daily and professional life. However, the combined effects on the physical performance     variables, such as aerobic and neuromuscular performance lack of evidence in the literature.   "
89302|NCT02117180|"     This pilot study aims to establish whether a low FODMAP diet is safe in children with     functional gastrointestinal disorders. The practicality of implementing this diet will be     evaluated as well as symptom improvement and quality of life. A larger intervention trial, if     deemed appropriate, will then follow to assess symptom efficacy in children.   "
89303|NCT02117167|"     Open label multicentric randomized phase II trial, using high throughput genome analysis as a     therapeutic decision tool, aimed at comparing a targeted treatment administered according to     the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in     Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as     immunotherapy with maintenance therapy in patients without actionable genomic alterations or     non eligible to substudy 1 (immune substudy 2).   "
89304|NCT02117154|"     This study aims to evaluate relative contributions of fasting plasma glucose and postprandial     glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship between     HbA1c, CGM, serum fructosamine and eAG, will also be looked into.      HYPOTHESES:        1. Fasting hyperglycaemia is the main contributor in Malaysian T2DM patients with poor          glycaemic control (high HbA1c), postprandial hyperglycaemia plays a more important role          with lower HbA1c levels.        2. There is good correlation between HbA1c, CGM, serum fructosamine and eAG in Malaysian          patients.   "
89305|NCT02117141|"     -  Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in          both fed and fasted states        -  Evaluate the safety and tolerability of the test compound administered orally   "
89306|NCT02117128|"     We will investigate the efficacy and safety of using tranexamic acid by intravenous,     intra-articular and combinational administration to reduce blood loss during total knee     replacement. We hypothesize a combined intra-articular and single intravenous dose protocol     of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and     extra-articular bleeding site with little or no systemic absorption and subsequent systemic     side effects.   "
89311|NCT02117063|"     The main purpose of this study is to determine if the Go Girls! program to take place at the     Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to     introduce girls to a fun, non-threatening environment of exercise with peer support, improves     scores on a physical activity enjoyment scale (PACES). Information regarding enjoyment of     physical activity before and after the program will allow objective evaluation of whether the     program is achieving its mission. Qualitative responses to the questionnaires will give     program leaders a better sense of potential attitudes and barriers to regular exercise for     teen girls. These responses will be used to shape activities during this or future programs     for teens. Anthropometric (e.g. body weight, blood pressure, waist circumference) and     biochemical (bloodwork) data will allow us to determine whether any change in metabolic risk     factors can be seen from this 6-month once weekly intervention.   "
89312|NCT02117050|"     This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment     satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently     being treated with, but are considering discontinuing treatment with Tecfidera™.   "
89313|NCT02117037|"     This prospective study aimed to validate a new prognostic approach of endothelial progenitor     cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made     prospectively by two centers of Inter -region South Mediterranean,   "
89314|NCT02117024|"     This study will test whether vaccination with viagenpumatucel-L combined with low-dose     cyclophosphamide will prolong the survival of patients with non-small cell lung cancer     (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease     compared with chemotherapy alone. Patients will be randomized 2 to 1 into the     viagenpumatucel-L arm and the chemotherapy alone arm, respectively.   "
89315|NCT02117011|"     Radiation therapy (RT) is often used to treat breast cancer. RT combined with breast surgery     is associated with better outcomes in early stage breast cancer compared to surgery alone.     Fatigue is one of the most important side effects of RT because it can decrease patients'     quality of life.      Studies found that physical activity (PA) may help to improve quality of life in cancer     survivors. PA has been reported to lower fatigue, anxiety, and depression. Physical     inactivity over a long period of time may lead to rapid energy and physical function loss.      PA intervention studies in patients undergoing RT have included mostly White patients. There     is no evidence on African American patients undergoing RT. The purpose of this study is to     examine the efficacy of a structured, moderate-intensity, aerobic exercise program in     reducing cancer-related fatigue in African Americans undergoing RT for localized breast     cancer.   "
89316|NCT02116998|"     This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be     randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will     receive up to 3 doses at 4 week intervals.      Following the third dose, subjects will be inoculated intranasally with S. pneumoniae     serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained     pre-inoculation, and then 2, 7 and 14 days after inoculation.      Subjects will also be monitored for safety and tolerability throughout the dosing period, and     then for 12 months after their last dose.      The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing     colonization rates and magnitude of colonization following the S. pneumoniae challenge.   "
89317|NCT02116985|"     Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of     Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it     difficult to judge the depth of anesthesia according to traditional hemodynamics index such     as heart rate and blood pressure.In case of this, the investigators design this research to     study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided     by a Narcotrend index monitor in Laparoscopic Cholecystectomy.   "
89318|NCT02116972|"     This study is a double-blind, randomized, parallel group, dose-ranging, single dose design.     The study will be conducted in male and female patients ≥ 40 years of age with osteoarthritis     (OA) of the knee.      Approximately 300 patients with OA of the knee will be randomized to one of three treatment     groups (1:1:1) and treated with a single intra-articular (IA) injection of:        -  16 mg FX006,        -  32 mg FX006, or        -  normal saline.      Each patient will be evaluated for a total of 24 weeks following a single IA injection.     Following screening, safety and efficacy will be evaluated at 6 out-patient visits (Days 1     [Baseline], Weeks 4, 8, 12, 16, 20 and 24).   "
89319|NCT02116959|"     The purpose of this study is to test the safety of the treatment combination of alternating     standard chemotherapy and another (melphalan) chemotherapy at different interval schedules.     Researchers want to find out what effects, good and/or bad, the treatment combination has on     the patients and their retinoblastoma.   "
89367|NCT02116335|"     Our bodies respond differently to stress. Animal studies by the investigators have found that     endothelin-1 plays a role in regulating blood pressure in response to stress. This study is     an extension of the investigators previous animal work to evaluate the role of endothelin-1     during stress in humans.   "
89320|NCT02116946|"     This is a randomized controlled clinical trial to investigate the effectiveness, safety and     tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy     in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment     groups:        1. Leukocyte-rich PRP injection + exercise        2. Leukocyte-poor PRP injection + exercise        3. Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and          severity of adverse events as reported by both patients and study physicians during the          first 12 weeks after initiation of treatment, (2) patient-rated tolerability of          treatment; (3) the change in function (VISA score) and treatment success (global          improvement scale) over six months of a post-injection exercise protocol.   "
89321|NCT02116933|"     Grafting of autologous stromal cell trial is a prospective study comparing routine fat     grafting versus stromal vascular fraction enriched fat grafting.   "
89409|NCT02115789|"     Surgical wounds can be closed in several manners. Some physicians believe that closure in a     straight line produces a scar that is more visible and slightly raised when compared to     closure in a zigzagging fashion. The researchers of this study believe that there is no     difference in the cosmetic appearance of one type of wound closure over the other. To     evaluate this, they will provide a survey with visual aids to volunteers to rate the     appearance of a straight line scar versus a zigzag scar.   "
89322|NCT02116920|"     AIM: To develop and standardize a cost effective methodology or algorithm for mRNA E6/E7 for     HPV genotypes 16, 18, 31, 33 and 45 as compared to commercially available assays which can be     incorporated to triage excess false positives from primary screening for cervical cancers      Objectives:        1. Development and standardization of methodology /algorithm for mRNA E6/E7 testing for HPV          genotypes 16, 18, 31, 33 and 45 using Real-time RT-PCR, in cervical samples.        2. To compare the test performance of this HPV E6/E7 mRNA assay to HPV DNA by HC 2 as          secondary screening test, with the reference standard of colposcopy with biopsy, to          triage women found positive in primary screening by VIA , in a population based          screening for cancer of cervix.        3. To determine number of false positives in the primary screening test after testing VIA          positives with a known high specificity secondary screening test (HPV-DNA HC II )          compared to HPV E6/E7 mRNA testing.      Study Population: Women in the age group of 30-65 years, who test positive on primary     cervical screening test VIA will be enrolled for the proposed diagnostic tests along with     reference standard of colposcopy with guided biopsy.      Methodology:      Women in the age group of 30-65 years undergoing routine cervical cancer screening through     hospital ( Preventive Oncology screening clinic) and community based screening programs with     abnormal test result using the primary cervical cancer screening test VIA will be recruited     in the study. The primary screening test VIA will be administered by application of 5% Acetic     Acid to the cervix and visualizing the cervix with the help of a halogen focus lamp. VIA will     be considered to be positive if definite acetowhite lesions are visualized close to the     squamocolumnar junction.   "
89323|NCT02116907|"     This is an open-label, single-dose study in healthy male subjects. The study will have 2     phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will     consist of a Screening Period and a Baseline Period, during which each subject's study     eligibility will be determined and baseline assessments will be conducted.   "
89324|NCT02116894|"     The primary objective of this open-label phase Ib trial is to determine the maximum tolerated     dose and the recommended phase II dose for the combination of PF-03446962 plus regorafenib in     patients with metastatic colorectal cancer. The secondary objectives are to describe the     safety and tolerablility, and to describe the clinical activity of PF-03446962 plus     regorafenib in terms of response rate and progression free survival   "
89325|NCT02116881|"     Despite of technological advances in surgery, incisional hernia and bowel obstruction remain     frequent surgical complications. To date, the relationship between these two types of surgery     and the occurrence of incisional hernia remains unclear. This is an observational study to     evaluate outcomes of incisional hernia with respect to the incision site and adhesion-related     bowel obstruction after open and laparoscopic colorectal surgery.   "
89326|NCT02116868|"     The purpose of this study is to determine whether analgesia guided by pupillary reflex during     laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and     postoperative morphine).This is a prospective, randomized, controlled study performed in two     centers.   "
89327|NCT02116855|"     A multi centre two year long term escalating dose tertiary prophylaxis study on the efficacy     and cost saving of individualized low dose prophylaxis regimens for boys with severe     hemophilia A in China staring with a low dose regimen in step I, an escalated low dose     regimen in step II and a tailored dose regimen based on individual PK profiles in step III.     The dose escalation criteria are adjusted according to patterns and frequencies of joint     bleeding and assessed in each subject every 3 months. Efficacy of the 3 different dose     regimens are measured by the Annualized Joint Bleeding rate (AJBR) as a primary end point and     the Hemophilia Joint Health Score (HJHS ) and QoL scores (CHO-KLAT and PedsQoL) , image     studies of target joints by Ultrasound, X-ray and MRI examinations, consumption of factor     VIII and inhibitor rates as secondary end points.   "
89328|NCT02116842|"     Local anaesthetics are highly toxic drugs. They can cause toxicity by an absolute overdose,     accidental injection in a blood vessel or slow absorption from the area of injection. The     risk of toxicity when performing regional anaesthesia can be reduced significantly by     injecting the optimal dose of local anaesthetic at the correct site.      To date most of the local anaesthetic dose finding studies for epidural labour analgesia has     focused on ED50 ( the dose effective in 50% of patients). The purpose of this research study     is to find out the ED95 dose (the dose effective in 95% of patients) of local anaesthetic for     epidural analgesia in labour.      The dose determined from this research trial will guide the anaesthetists to the optimal     starting dose of the local anaesthetics for epidural analgesia in labour. This would lead to     decreased chances of toxicity and will improve patient safety.      We aim to recruit a total of 100 pregnant patients in early labour (cervical dilatation ≤ 5     cm) requesting epidural analgesia to answer the research question based on the continual     reassessment method. Patients will be recruited according to well-defined criteria. They will     be fully informed about the study and have the choice of not participating or opting out at     any time during the study. It is not going to affect the kind of treatment they receive. The     experts in the field with full safety precautions will perform this study at St James'     Hospitals, Leeds.   "
89329|NCT02116829|"     The aim of this study is to examine the effects in humans of a moderate butter intake on risk     markers of cardiovascular disease compared to a diet with the same amount of olive oil     (refined and therefore without polyfenols).      The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The     secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well     as the inflammatory marker hs-CRP.   "
89354|NCT02116504|"     One of the main potential causes of these failures of BP therapy response is the development     of Anti-drug Anti-body (ADAb) in some patients. ADAb may decrease the efficacy of BPs by     neutralizing them or modifying their clearance and they may be associated with BP-specific     hypersensitivity reactions. The prediction, prevention and cure of anti-drug (AD)     immunization are thus major goals in BP development. This prospective study (ABI-RA) will     assess the occurrence of ADAb using standardized and validated assay(s) and also cellular,     genetic and molecular parameters in RA/JIA patients treated with adalimumab, etanercept,     infliximab and rituximab or tocilizumab, to address the mechanism of immunogenicity.     Patient-related factors that might predispose an individual to an immune response will be     taken into account: underlying disease, genetic background, immune status, including     immunomodulating therapy and dosing schedule.   "
89330|NCT02116816|"     This study consists of two parts. The first part of the study looked at the absorption of     three different polyphenol preparations into the blood, the variability of their absorption     and whether their absorption could be enhanced by mixing with pollen shells. For this purpose     12 healthy volunteers were recruited. All participants received all the 3 supplements with     and without mixing with pollen shells so they had a total of 3 tests. For each test six blood     samples were taken over an 8 hour period. Urine samples were also collected.      Oligopin was selected from the first study. The second part of study aims to look at the     effects of Oligopin on endothelial function by assessing vascular tone and function in     healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity     (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will     also be recorded to provide a clear clinical assessment of the effects of this preparation     (if any) upon vascular function. The effects of Oligopin will be compared to a placebo     (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A     total of 24 healthy volunteers will be recruited for this study.   "
89331|NCT02116803|"     The study allows continued safety follow-up of patients who are on single agent dovitinib or     dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which has     met its primary endpoint and are benefiting from the treatment as judged by the investigator.   "
89332|NCT02116790|"     Findings from the investigator's lab and others' show the involvement of the brain's     mesolimbic circuitry in pain perception and evaluation, as well as during the transition from     acute to chronic pain states in both humans and animals. Dopamine (DA) is one of the main     neurotransmitters in this circuitry, and it is possible it could have an intimate role in     pain processing, chronicity, and related anatomical and functional neuroplasticity. In this     study, the investigators first need to know if the combination of l-dopa and Naproxen is safe     and efficacious in humans with acute pain, and if so, at what doses. For the present study,     healthy pain-free participants will be injected with a small bolus of capsaicin     subcutaneously to induce acute cutaneous inflammatory pain. Capsaicin is ideal for this study     because it causes a characteristic inflammatory response that is almost always accompanied     with pain, has a well-validated dose-response curve, and has effects that will go away     completely in a few hours after administration, causing no permanent damage to study     subjects. Effects of capsaicin will be measured by changes (decreases) from baseline in     thermal and tactile thresholds, as well as by verbally reported cutaneous pain levels (on a     scale from 0-10). Participants will also be given study medication in the form of a placebo,     one drug, or a combination of drugs before capsaicin injection to allow for any analgesic     effects to peak before pain onset. For those receiving active medication, they will either     receive Naproxen with placebo or the combination of naproxen and l-dopa (the latter of which     will be in one of two different doses). This will allow the investigators to investigate (1)     whether co-administration of naproxen and l-dopa has analgesic effects in low levels of acute     pain in humans, (2) if this combination is pain-alleviating, whether it is equally as or more     efficacious than naproxen, which is the clinical standard of treatment, and finally (3) what     dose provides the most analgesia.   "
89333|NCT02116777|"     This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide     and to see how well they work in treating younger patients with tumors that have not     responded to previous treatment (refractory) or have come back (recurrent). Talazoparib may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Giving talazoparib together with temozolomide may work better in     treating younger patients with refractory or recurrent malignancies.   "
89334|NCT02116764|"     This study is a longitudinal and cross-sectional evaluation of patients with Chronic     Granulomatous Disease (CGD) who received or are receiving hematopoietic cell transplantation     (HCT) for their disease under a variety of protocols used by participating institutions     compared to a control non-HCT group receiving standard care. Investigators at multiple     centers caring for patients with CGD in North America and 3 centers in Europe will     participate. Patients with CGD will have been treated according to institutional practice and     protocols. Investigators will enroll these patients as subjects in this protocol. This study     will investigate which patients benefit most from HCT, and what types of transplants are     optimal for patients with CGD, in the context of overall outcomes in CGD patients with and     without transplant.   "
89335|NCT02116751|"     The purpose of this study is to determine the frequency of renal and bone toxicity in HIV     infected patients receiving antiretroviral therapy, and the outcome in terms of treatment     change or/and virological failure, in relation with the presence of classical factors, such     as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the     effects of antiretroviral medication.   "
89336|NCT02116738|"     The investigators want to share our study that is the Comparison of Modified Limberg Flap     Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the     Surgical Treatment of Sacrococcygeal Pilonidal Sinus.   "
89337|NCT02116725|"     Zinc is an important metal for the maintenance of healthy skin and wound healing. Washing     with detergents e.g. shower gels may deplete the zinc stores in the skin.      The purpose of our study is to see whether repeated washing with zinc containing shower gel     of superficial wounds will result in increased healing.   "
89338|NCT02116712|"     Lymphangioleiomyomatosis (LAM) is a rare lung disease that mostly affects women of     childbearing age. In LAM, abnormal, muscle-like cells begin to grow out of control in the     lungs. As a result, air can't move freely in and out of the lungs. In some cases, this means     the lungs can't supply the body's other organs with enough oxygen.      This study is being conducted to find out what dose of a drug called saracatinib is best     tolerated by people with LAM. This drug has been tested in patients with certain types of     cancer but is not currently approved by the United States Food and Drug Administration (FDA).     Saracatinib may work in cancer by preventing the growth, movement and invasiveness of cancer     cells. The use of saracatinib to treat LAM is considered experimental. Preliminary testing     already completed suggests that the study drug, saracatinib, may suppress certain substances     in the lungs of patients with LAM thus may be effective in slowing down the disease process   "
89339|NCT02116699|"     Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own     mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in     immune factors which may provide immunostimulatory effects when administered oropharyngeally     to extremely premature infants during the first weeks of life. The investigators hypothesize     that infants who receive oropharyngeal mother's colostrum and milk will have significantly     lower rates of infection and improved health outcomes, compared to infants who receive a     placebo.   "
89341|NCT02116673|"     Background: Head injury is a common presentation to family medicine clinics and emergency     departments (EDs), and the majority will not result in intracranial injury requiring     neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It     is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS).     Research in the management of MTBI and prevention of PCS has been scarce to date. Although     expert consensus recommends cognitive rest and graduated return to usual activities, these     and other interventions are not based on prospective clinical evidence.      Objective: The purpose of this study is to determine if providing graduated return to usual     activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms     post-injury as compared to providing usual ED MTBI discharge instructions.      Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority     randomized trial.      Patient Population: Male and female patients presenting to the ED ages greater than 17 and     less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting     complaint of head injury.      Outcomes: The primary outcome of this study is to determine if patients whom receive     graduated return to usual activity discharge instructions have more clinically significant     decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients     who received usual care MTBI discharge instructions. Secondary outcomes include the     intervention group's compliance with the intervention, comparison of PCSS between groups 4     weeks after initial ED visit, comparison of groups' number of return visit(s) to either an ED     or physician's office, and the mean number of days of school or work missed for each group.      Hypothesis: Given cognitive rest and graduated return to usual activities are concepts     recommended by expert consensus, it is expected patients who follow the graduated return to     usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks     after ED discharge.   "
89342|NCT02116660|"     To evaluate changes in renal function, efficacy, and safety when switching from a combination     of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a     combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human     immunodeficiency virus (HIV)-1 participants with suppressed viremia and impaired renal     function.   "
89343|NCT02116647|"     In India, precisely northern states, skewed sex ratios, female feticide and higher child     mortality rates for girls have become serious concern. The female child mortality as a result     of son preference have increased during the last several decades .Since families cannot know     the sex of the fetus due to Indian government policies, maltreatment and serious neglect has     been tools to ensure there are few survivors.   "
89344|NCT02116634|"     Whether the mesenchymal injection on ALS patients is effective or not?   "
89345|NCT02116621|"     Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in     a trial and error fashion. Clinicians prescribe a treatment to a patient and then wait and     see if the treatment is successful. If the treatment is unsuccessful, they will try a     different treatment. The disadvantage to this method is that it may take a long time to find     a successful treatment.      The purpose of the PREEMPT Study is to test whether using a mobile phone application     (Trialist app) that allows patients and their health care providers to run personalized     experiments comparing two pain treatments is more effective than usual care. Patients     download the app, and working with their clinicians, set up a personalized trial that makes     sense for them. Every day they answer questions to track levels of pain and side effects of     treatment, such as fatigue and constipation. Once the personalized trial has ended, the     responses to these daily questions on each treatment will be compared. During a regular     clinic visit, the patient and the clinician will review visual displays of the results to     facilitate treatment decision-making. Approximately 250 patients will be enrolled in the     study. Half the patients will use the app and review results with the clinician, and half the     patients will continue with their regular care (i.e., will not use the app). The two groups     will be compared to see if using the app is successful in improving long term pain outcomes.     The goal of the intervention using the Trialist app is to help patients engage actively and     collaboratively with their clinicians and identify effective treatments more quickly.   "
89346|NCT02116608|"     This study plans to learn more about the different ways used to treat tracheostomy     granulomas. Investigators want to see which standard of care method (steroid application,     silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.   "
89347|NCT02116595|"     Presently, the gold standard for testing diet acid intake is a urine collection done for many     hours, usually 24 hours, which must be analyzed in a research lab for net acid excretion.     So, getting information about diet acid intake is difficult. Many people have suggested doing     a much simpler test, which is checking the pH of the urine when you wake up. But, no one has     studied if this simpler method is a valid method for estimating the 24 hour net acid     excretion. Diet acid load may be important in many diseases associated with aging, such as     loss of bone and muscle, and the development of kidney disease.   "
89349|NCT02116569|"     The purpose of this study is to evaluate the tolerability and safety of Daratumumab in     Japanese participants with relapsed (the return of a medical problem) or refractory (not     responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow,     characterized by the presence of abnormal proteins in the blood).   "
89350|NCT02116556|"     Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of     Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of     debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of     death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal     decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves     liver function and reduces the complications of decompensated alcoholic cirrhosis.      The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the     development of infections associated with AAH and analyze its consequences.   "
89351|NCT02116543|"     This proof of concept study is designed to evaluate the safety, tolerability,     pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1,     GT-2 or GT-3 chronic HCV.   "
89352|NCT02116530|"     This randomized phase III trial studies antiemetic therapy with olanzapine to see how well     they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and     vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy.     Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron     hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with     chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by     blocking brain receptors that appear to be involved in nausea and vomiting.   "
89353|NCT02116517|"     Green tea is one of the most popular beverages in the world. It is believed to have     beneficial effect in prevention and treatment of many diseases, one of which is reducing     LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese     with high LDL level.   "
89355|NCT02116491|"     BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter     (visual sputum suctioning system or VSSS), which the investigators previously tested in vitro     and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.      PURPOSE: The purpose of this study was to investigate the safety and efficacy of sputum     suctioning system in mechanical ventilated patients in respiratory intensive care unit     (RICU). The investigators compare the weight of secretions collected, vital signs, and     tracheal wall injury between two groups of patients randomized to have VSSS combined with     closed system suction (CSC) suction and patients having CSC suction alone.      HYPOTHESIS: The investigators theorized that the VSSS collected more sputum and caused less     change of vital signs than conventional CSC.   "
89356|NCT02116478|"     The purpose of the study is to compare the clinical results for patients suffering from     plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.   "
89357|NCT02116465|"     The study is carried-out to describe and compare the plasma pharmacokinetics of levodopa and     carbidopa after oral single-dose administration of 100 mg levodopa plus 25 mg carbidopa by     means two fixed combination products (test: Isicom® 100/25 mg; reference: Nacom® 100/25 mg).      Additionally, to describe and compare the safety and tolerability of the two investigational     treatments administered to healthy subjects.   "
89358|NCT02116452|"     The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect     in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in     infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that     prebiotics reduce the severity of the disease.   "
89359|NCT02116439|"     The main objective of this study is to determine the average total number of violent events     per observation period occurring in the emergency department at the Nîmes University     Hospital. The list of violent events is pre-determined and based on a series of interviews     with emergency department staff.   "
89360|NCT02116426|"     The main objective of our study is to evaluate the diagnostic value of copeptin testing in     association with troponin HS testing during pre-hospital care (ambulance care) in the     treatment of patients whose pattern of use is the occurrence chest pain suggestive of ACS but     not ST+.   "
89361|NCT02116413|"     The main objective of this study is to evaluate in a population of patients with septic shock     receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as     responders to the fluid challenge (increase of at least 15% of ITV in aortic) at the end of     vascular filling (T10) and becoming non-responders 20 minutes after the end of the fluid     challenge (T30) and whether this proportion is greater than 10 points.   "
89362|NCT02116400|"     The main objective of this study is to evaluate decision-making using the Iowa Gambling Task     (IGT) among patients with euthymic bipolar disorder according to their personal history of     suicide attempt (suicidal vs. not suicidal ).   "
89363|NCT02116387|"     The main objective of this study is to evaluate in patients with chronic low back pain     (lasting for more than 3 months and not postoperative) the effect of an instrumental     rehabilitation using the I-Moove ® device compared to a conventional physiotherapy     rehabilitation for ambulatory postural stability (mean and standard deviation of excursions     from the center of gravity) without visual control, 6 weeks after the start of the     rehabilitation protocol. We focus on the relative variation between the values obtained on     day 0 versus 6 weeks, via measures performed on a force platform. The results will be     stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).   "
89364|NCT02116374|"     The bacterial diversity of HIV patients digestive microbiota seropositive is poorly     understood, it remains to be defined.   "
89365|NCT02116361|"     This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with     placebo as treatment for major depressive disorder (MDD) in adult females.   "
89366|NCT02116348|"     Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic     burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct     non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of     $11.5 billion or $921,000 average cost per person. Associated disabilities as mental     retardation, delayed speech development add psychological burden of the disease on the family     as well as economic burden.      Mental retardation is the major problem in children with cerebral palsy. Improving mental     development will have a positive effect on quality of life for the child and his family.     Treating associated impairments (mental retardation) with Cerebrolysin will improve mental     development and quality of life, and will decrease the economic burden in children with     cerebral palsy.   "
89368|NCT02116322|"     This research is being done to investigate if a new technique to biopsy the pancreas will     lead to a larger amount tissue material that can be analyzed. Investigators have called the     technique the corkscrew technique and believe it will allow obtaining a larger biopsy     sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise     rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener     twists and buries itself into a cork). It is believed that this will lead to a better biopsy     sample than the usual way and therefore result in a higher chance of a diagnosis.   "
89369|NCT02116309|"     This research is being done to see if using a combination of rectal indomethacin and     epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a     type of gastrointestinal endoscopy).   "
89379|NCT02116179|"     The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month     follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV     intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse     treatment clients to either the experimental intervention or to a wait list control group;     and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based     intervention.      They study hypothesis are the following:        1. participants in the intervention condition will report greater reductions in sexual risk          behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared          to the control group;        2. participants will report greater reductions in drug risk behaviors (e.g., sharing          injection equipment, drug use during sex) from baseline to 3 month follow-up compared to          the control group;        3. participants who report more HIV prevention information, motivation, and behavioral          skills will report fewer sexual risk behaviors.   "
89370|NCT02116296|"     The ToyBox proposal addresses Knowledge-Based Bio-Economy (KBBE)-2009-2-1-03 - Behavioural     models for prevention of obesity, with a particular focus on children. It will primary aim to     influence children's behaviours and prevent obesity in early childhood. The proposal will     identify key behaviours related to early childhood obesity and their determinants and     evaluate behavioural models and educational strategies. Based on the obtained insights at a     local level, a multidisciplinary team will develop and implement a school based family     involved intervention programme that could be applied on a European scale. Process, impact,     outcome and cost-effectiveness evaluation will be conducted to support decision making for     European Public Health Policy. The combined use of Precede-Proceed Model and Intervention     Mapping will provide the framework for the development, implementation and evaluation of the     ToyBox intervention. To achieve this, the project will be subdivided into 10 Work Packages     (WPs). This carefully planned stepwise approach will include systematic reviews, secondary     analyses of existing data sets, focus group research and school policies overview. The ToyBox     project consortium spans the necessary multidisciplinary variety of experts such as public     health experts, epidemiologists, nutritionists, physical activity experts, pedagogists,     psychologists, behavioural scientists, nutritionists, paediatricians, early childhood     psychologists, health economists, totalling 15 partners, from 10 countries. The consortium,     consists of 11 universities, 1 research institute, 2 advocacy groups and a small to medium     enterprise (SME) representing all regions of Europe. The consortium has ample experience in     conducting and coordinating multi-centre international research as well as undertaking     dissemination activities to all relevant stakeholders.   "
89371|NCT02116283|"     Smokers will use a smartphone app on a smartphone provided for the study that will passively     sense and record information about their activities. Information collected from the     smartphone app will be used to develop future smartphone apps that will predict when an     individual is at risk of smoking.   "
89372|NCT02116270|"     The aim of this study is to investigate the impact of renal function and dialysis techniques     on the percentage of senescent T lymphocytes.   "
89373|NCT02116257|"     While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree     of postoperative pain, it can also affect the patient's outcome by several adverse effects     such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients     for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be     sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and     is used widely for post operative pain management. This study aims to see the opioid-sparing     effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.   "
89374|NCT02116244|"     Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye,     tear film, and related ocular tissues. Millions of people suffer from one form of the disease     or another and its prevalence increases with age. Dry Eye Syndrome sufferers experience a     broad range of symptoms including discomfort, irritation, burning, itching, redness, pain,     gritty feeling, foreign body sensation, blurred vision and ocular fatigue. Civamide is a     TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide release and     subsequent desensitization to further stimulation of the trigeminovascular system. This     provides a pharmacological rational for intranasal route of administration for disorders     mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical studies of     Civamide Nasal Solution, over 50% of the nearly 300 patients who received Civamide via     intranasal administration experienced lacrimation (tearing). This led to the hypothesis that     Civamide Nasal Solution might be an appropriate treatment for Dry Eye Syndrome.   "
89375|NCT02116231|"     The study is designed to compare Intensity Modulated Radiotherapy (IMRT) in combination with     concurrent chemotherapy and IMRT alone in treatment of stage II nasopharyngeal carcinoma.   "
89376|NCT02116218|"     Pain control is a common and serious problem in cancer patients. Although WHO has developed a     three-stage model of cancer pain management, 80% cancer patients still suffer moderate to     severe pain in their daily life. When patients are with acute exacerbation or aggravate of     pain, they usually visit the emergency department for more help.      Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used     as a complementary therapy among patients with cancer. It can not only relieve pain in cancer     patients, but also can reduce some of the side effects caused by some treatment.      This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with     acute pain onset through emergency department with objective Traditional Chinese Medicine     assessment.   "
89377|NCT02116205|"     The purpose of this study is to compare the immune responses of two different doses (1.0 mg     and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan     virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a     blind, participants in the two-dose group will receive one dose of normal saline placebo. All     of the groups will also receive a booster dose 6 months after first vaccination. The results     will help to determine which dose and vaccination schedule will be best to move forward in     the vaccine development process.   "
89378|NCT02116192|"     This research study intends to learn about whether early intervention can help to prevent     non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents     who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to     join the study. Patients who agree to participate in the study will be randomized into either     the intervention group or the control group. The intervention group will follow a     low-fructose diet. In addition, participants will be asked to return to the clinic for 4     follow-up visits during a 6-month interval.   "
89434|NCT02115464|"     ALMERA is a randomized, phase II, open label study in patients with locally advanced     non-small cell lung cancer (NSCLC) which will compare standard radiotherapy plus concurrent     chemotherapy with or without consolidation versus the same treatment plus concurrent     Metformin continuing for 12 months. Metformin is a well tolerated and inexpensive drug that     has the potential to improve cancer patient outcomes.   "
89380|NCT02116166|"     The purpose of this research study is to investigate how and why the loss of muscle mass     occurs with aging. Tissue collected from young subjects will be compared to previously     collected tissue from elderly subjects, as well as previously collected data on muscle     function/mass to further investigate cellular and molecular pathways that have recently been     shown to be important for the aging process in muscle. The Principal Investigator (PI) and     the study team will look for specific proteins (called biomarkers) that can be present in the     muscle tissue in various amounts in different individuals. This study will increase the     investigators understanding of the processes of muscle atrophy (loss of mass) and functional     loss at older age and will help to find new treatments and interventions aimed at improving     the quality of life and independence of America's rapidly expanding elderly population.   "
89381|NCT02116153|"     Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency     department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the     biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction     (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of     non-STEMI and the detection of troponin in individuals that would have been classified as     unstable angina with former assays. As many patients are detected with elevated troponin     values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased.     Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that     allow specific identification of myocardial infarction. The aim of this study is to develop a     biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high     specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.   "
89382|NCT02116140|"     Obstructive sleep apnea (OSA), central sleep apnea (CSA) and heart failure (HF) are states of     metabolic demand and sympathetic nervous system (SNS) activation. In patients with sleep     apnea and HF, continuous positive airway pressure (CPAP) initially may reduce left     ventricular (LV)stroke volume (SV) but subsequently improves and LV function. This may relate     to an early beneficial effect on myocardial energetics through early reduction in metabolic     demand that subsequently leads to improved efficiency of LV contraction. However, it is not     clear whether long-term adaptive servo-ventilation (ASV) favorably affects cardiac     energetics. Any such benefit may also relate to reduced sympathetic nervous system (SNS)     activation. However its effect on myocardial SNS function is also not well studied.      In a pilot study we demonstrated early (6 week) beneficial effects of CPAP in patients with     OSA and HF. The current proposal (AMEND) is a unique substudy of the recently funded     ADVENT-HF trial (Adaptive Servo Ventilation for Therapy of Sleep Apnea in HeartFailure)     (NCT01128816; CIHR; D. Bradley, PI).      We propose to evaluate the long-term (6 month) effects of ASV on daytime 1) oxidative     metabolism; 2) the work metabolic index (WMI) as an estimate of mechanical efficiency; 3)     myocardial sympathetic nerve (SN) pre-synaptic function; and 4) heart rate (HR) variability     in patients with HF and coexisting OSA or CSA. In conjunction with echocardiographic measures     of LV stroke work, positron emission tomography (PET) derived [11C] acetate kinetics will be     used as a measure of oxidative metabolism, to determine the WMI. [11C] hydroxyephedrine (HED)     retention will be used to measure cardiac SN pre-synaptic function.      Primary Hypotheses: In patients with chronic stable HF and CSA or OSA without excessive     daytime sleepiness (EDS), long-term (6-month) ASV therapy yields:        1. Beneficial effects on daytime myocardial metabolism leading to a reduction in the rate          of oxidative metabolism as measured by [11C]acetate kinetics using PET imaging;        2. Improvement in energy transduction from oxidative metabolism to stroke work as measured          by an increase in the daytime work-metabolic index.   "
89383|NCT02116127|"     The purpose of this pilot study is to examine the feasibility of conducting a multi-site     double-blind randomized controlled trial whose aim will be to evaluate the effectiveness of     transcranial direct current stimulation (tDCS) for treatment in pregnant women with moderate     to severe major depression.   "
89384|NCT02116114|"     We have as hypothesis that the aquatic aerobic physical training program can help promote     beneficial adaptations on the cardiovascular, respiratory and systemic inflammation     variables, functional capacity and quality of life in patients with chronic obstructive     pulmonary disease (pulmonary emphysema).   "
89385|NCT02116101|"     This was a randomized, double-blind, single-center, placebo-controlled, two-arm study. The     objectives of this study were to evaluate the effect of Momchilovtsi yogurt on:        1. Improving intestinal digestion and bowl movement;        2. Adjusting blood total Cholesterol and Triglycerides levels;        3. Adjusting microbiological flora (Clostridium perfringens bacteria, Lactobacillus and          Bifidobacterium) in gastrointestinal tract;        4. Adjusting short chain fatty acids (acetic acid, propionic acid, butyric acid) in in          gastrointestinal tract.   "
89386|NCT02116088|"     Children with externalizing problem behaviour are at risk of developing educational     impairment, because of their problems in rule following, social behaviour and attention. This     behaviour represents a great challenge for teacher. In addition, time pressures and conflicts     with colleagues are the most common sources of stress for teachers. Till now teachers receive     no evaluated training which in particular regards externalizing problem behaviour. Therefore     we develop and evaluate an indicated prevention program for elementary school teachers with     children with externalizing problem behaviour. All teachers of a participating school are     given a general overview of externalizing problem behaviour (etiology, diagnosis) and     information on evidence-based treatments for children with externalizing problem behaviour in     school settings. Single teachers will then participate in a 12 week coaching in which they     learn to apply classroom management techniques, strategies to improve their relationships     with children, behaviour modification techniques and cognitive interventions to specific     target children. The coaching intervention is based on functional behavioural analysis and     provides teachers with evidence-based strategies which focuses on one target child.      Longitudinal data will be collected in a within-subject control group design. Dependent     measures include teacher and observer reports.   "
89387|NCT02116075|"     Study comparing caudal prolotherapy to conventional steroid for chronic low back pain   "
89388|NCT02116062|"     The introduction of surgical robots in the OR revolutionized a number of specialties (i. e.     urology, gynecology, digestive surgery). Robots are currently used in many situations and the     list of appropriate indications is growing rapidly. There are many potential advantages of     robotics in eye surgery such as increased precision and maneuverability, better ergonomics,     improved patient access to surgeons and surgical training. As a result, robotics might     improve patient care. The Da Vinci© robot has been used for 10 years in experimental     conditions to suture corneal lacerations, to perform corneal grafts, to remove ocular foreign     bodies, lens capsules and vitreous. The authors reported a lack of precision resulting from     poor visualization and the absence of microsurgical instruments. These elements were     considered to be hurdles to further clinical investigation. The new Da Vinci Si HD© robot has     been available since 2009 at the IRCAD center and more recently in Strasbourg University     Hospital. It provides greater magnification and better resolution of the operative field than     the previous model. We performed since 2012 various ocular surface surgeries on porcine eyes     at the IRCAD center. The aim of the present trial is to perform the same procedures (amniotic     membrane transplantations, pterygium surgeries, corneal grafts) in a clinical setting with     the Da Vinci Si HD© system.   "
89398|NCT02115932|"     People with diabetes can have nerve damage in their extremities (peripheral neuropathy), and     this can lead them to being less able to maintain their balance when they are standing,     walking or performing complex movement tasks in their day-to-day life. This results in them     being more prone to falls, and consequent injuries. The purpose of this study is to determine     whether providing strength and balance retraining (in the form of specific physical exercises     or activities) can help people with diabetic peripheral neuropathy regain their ability to     maintain their balance, increase their confidence in performing balance-based activities and     improve their quality of life.   "
89389|NCT02116049|"     Men who have sex with men (MSM) remain disproportionately represented in the national     HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual     behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an     HIV-positive status may be a key factor responsible for male-male HIV transmission. There are     no known intervention programs whose primary focus is to help MSM develop requisite skills to     disclose their status to casual sexual partners. The development of such interventions is     essential because of the numerous repercussions for not disclosing when one is HIV-positive     such as legal prosecution and the transmission of HIV. In a previous intervention development     study (R21MH067494) the research team created and tested a 4 session intervention found to be     promising for increasing disclosure to casual sexual partners. The purpose of the proposed     research is to further refine and enhance our HIV disclosure intervention (DI) designed to     increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among     HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an     attention control case management group (ACCM) for HIV-positive MSM; examine the effects of     the intervention over time; explore differential treatment responses to the disclosure     intervention and ACCM on the basis of ethnicity, age, and education level as well as examine     the mediating effect of baseline frequency of sexual activity, severity of substance abuse at     baseline, and stigmatized fear on the relationship between intervention type and the outcome.     Finally, the investigators will test how treatment engagement, retention and expectations     predict subsequent disclosure and risky sexual outcomes.   "
89390|NCT02116036|"     The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood     clotting (thrombosis). APS is among the most common cause of heart attack and stroke in     patients under the age of 50 and is particularly prevalent in patients with autoimmune     conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to     prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires     frequent bloodwork monitoring, and many medications or foods can alter its effect, which can     put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation     that prevents blood clots that does not require bloodwork monitoring and that has fewer     interactions. This study is a pilot feasibility study which will: 1) examine our ability to     identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of     these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily     rivaroxaban administration. The investigators propose to treat eligible patients with     rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their     rates of bleeding and thrombosis will be monitored as secondary outcome measures.   "
89391|NCT02116023|"     The study is a human dietary test meal study that is a randomized, controlled, double blind,     cross over design with 3 intervention arms that will investigate the subjective ratings of     satiety in response to different levels of processed whole orange compared with a     sugar-matched isocaloric control   "
89392|NCT02116010|"     The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage     treatment of E. coli or P. aeruginosa wound infections in burned patients.   "
89393|NCT02115997|"     This is a perspective, Phase IV, multi-center, single arm, open-label, interventional study     in adult participants with Wegener's granulomatosis (granulomatosis with polyangiitis [GPA])     or microscopic polyangiitis. Participants will be treated with rituximab (Ristova) and     glucocorticoids. Rituximab will be administered by intravenous (IV) infusion at a dose of 375     milligrams per meter square (mg/m^2) body surface area once weekly during Weeks 1 to 4.     Participants will also receive one or three pulses of methylprednisolone (1000 milligram [mg]     each), followed by a tapering dose of oral prednisolone (start dose of 1 mg per kilogram per     day). The dose of oral prednisone will be reduced as per evaluation by the investigator till     the participant is completely off the drug. The participants will be followed up for duration     of 6 months from the date of starting rituximab therapy with three follow-up visits at Days     52, 112 and 172. All adverse events occurring during this period will be captured.   "
89394|NCT02115984|"     The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory     activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases     in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with     distant metastases).   "
89395|NCT02115971|"     The aim of this pilot study is to analyze the effect of a 12-week specific jump training     compared with conventional therapy in patients with chronic functional instability of the     ankle. It is to be evaluated to what extent the symptoms in of chronic functional instability     of the ankle can be influenced in everyday life.   "
89435|NCT02115451|"     The aim of this study is to evaluate knee function, sports participation and knee reinjuries     over 2 years in a group of patients who choose either nonsurgical or surgical treatment for     an anterior cruciate ligament (ACL) injury   "
89436|NCT02114476|"     The purpose of this study is to determine the effect of implantable contraception on the     incidence of diabetes mellitus in women with history of gestational diabetes mellitus     comparing with those using nonhormonal contraceptives.   "
89396|NCT02115958|"     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors     into immunosuppressed mice, preventing an assessment on the immunologic interactions and     effects of CSCs. In this study, the investigators examined the vaccination effects produced     by CSC-enriched populations from histologically distinct murine tumors after their     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic     and more effective as an antigen source than unselected tumor cells in inducing protective     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor     immunity.   "
89397|NCT02115945|"     Total knee prosthetic replacement causes severe postoperative pain. Various analgesic     techniques have been used in pain control. Comparison of epidural and femoral nerve block is     lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare     the effects of epidural and femoral block on acute and chronic postoperative pain.   "
89399|NCT02115919|"     Caused by the human papillomavirus (HPV), anogenital warts are a common sexually-transmitted     infection (STI). They are distressing to those who have them and are a source of viral     shedding and transmission to others. Treatment of warts is aimed at destruction of the     lesion.      Objectives:        1. Establish safety of Multikine in treatment of perianal condyloma.        2. Describe presence of anal HPV and anal dysplasia in participants with perianal          condyloma.        3. Describe adverse effects associated with Multikine in the management of perianal          condyloma.      Design:      Phase I, dose-escalation trial. Potential participants desiring treatment for their perianal     warts will be referred to study by their primary clinician. All participants will undergo     baseline anal Pap, anal HPV subtyping, perianal condyloma characterization (count,     measurement, photography), and complete a baseline questionnaire. Cohort A participants will     undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14     days, off for 14 days, then again once daily, Monday through Friday for 14 days. If no     serious adverse events are noted after 4 weeks of therapy, cohort B will be studied using the     same schedule but with a dose of 400IU per treatment. Each participant will undergo anal Pap     and anal HPV subtyping once weekly during treatment. Condyloma characterization (count,     measurement, photography) will occur prior to each treatment. After treatment completed,     participants will complete a follow-up visit at 70, 100, 130, 160 days and have anal Pap,     anal HPV subtyping, and perianal condyloma characterization (count, measurement, photography)     performed.      Subjects:      The study will be open to adult men and women who are HIV-infected who receive medical care     from the Naval Medical Center San Diego.      Main Outcome Measures:        1. Perianal wart characterization [count, measurement (in millimeters diameter)],          photography)        2. HPV subtype in anal canal        3. Anal dysplasia cytologic grade        4. Questionnaire responses        5. Adverse effects experienced during treatment, recorded in symptom log   "
89400|NCT02115906|"     Growth hormone (GH) plays a pivotal role in the regulation of body composition including     ectopic lipid deposition in insulin sensitive organs like liver and skeletal muscle. Recent     evidence indicates that the GH-IGF1 axis affects body composition via regulating     mitochondrial oxidation capacity.      Thus, excessive GH secretion by a pituitary adenoma (Acromegaly) might be accompanied by     increased mitochondrial activity leading to inappropriately low intracellular lipid depots,     especially in metabolically active tissue like liver and skeletal muscle.      This study aims to assess metabolic activity and intracellular lipid content in skeletal     muscle and liver in patients suffering from acromegaly compared to controls by 31P/1H     Magnetic resonance spectroscopy before and in follow up examinations 3, 6 and 12 months after     initiation of GH lowering treatments including surgery, somatostatinanalogs or pegvisomant,     as well as oral glucose tolerance tests at each examination to assess treatment responses and     calculate validated parameters for insulin sensitivity and resistance.   "
89401|NCT02115893|"     The main aim of the current study will be to find the optimal duration of supplementation to     enhance sports performance.   "
89402|NCT02115880|"     The purpose of this randomised controlled trial is to see whether a group-based psychological     intervention for families can reduce the inflated risk of depression in children and     adolescents who have at least one parent who suffers from depression (or who has suffered     from depressed in the child's lifetime).   "
89403|NCT02115867|"     Diverticulitis is an extremely common digestive disease particularly found in the large     intestine in elderly patients and develops from diverticulosis. Diverticulosis is     characterized by the formation of pouches (diverticula) that bulge to the outside of the     colon, through areas of weakness in the colonic wall. Inflammation (diverticulitis) results     if one of these diverticula becomes infected and / or obstructed. It is commonly accompanied     by obvious or microscopic perforation, ranging in severity from a single, mild, acute attack     of diverticulitis to more severe attacks characterized by abscess formation, occasionally     resulting in chronic complications such as obstruction and fistula formation. After an     episode of diverticulitis many patients develop changes in bowel openings, from diarrhoea and     constipation, and many patients have abdominal pain and a symptom complex that resembles     Irritable Bowel Syndrome (IBS).      According to available guidelines, treatment of symptomatic, but uncomplicated, diverticular     disease aims to reduce the frequency and severity of diverticular related symptoms (abdominal     pain, bloating, alterations in bowel habit) and to prevent complications. Different agents     have been proposed, such as bulking agents, antispasmodics, and nonabsorbed topical     antibiotics, 5amino acid preparations but these measures are unproven or controversial. It is     thought that intestinal bacteria may play a significant role in the symptoms of     post-diverticulitis.      The investigators have recently shown that a probiotic (Symprove) reduced the symptoms of IBS     significantly in comparison with a placebo in a double-blind randomized trial and without     side effects (paper in preparation). Because the symptoms in IBS and post-diverticulitis are     so similar the investigators propose a double-blind placebo controlled trial of Symprove in     patients with problematic diverticulitis. Patients will be recruited from a dedicated     diverticulitis clinic using standard exclusion criteria. This is a 90 day symptom based trial     using accepted outcome measures. If successful the results will have widespread implications     for treatment of diverticular disease.   "
89404|NCT02115854|"     The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis     requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease     successfully treated with high dose steroids is not straightforward and may delay the     treatment choice by the physician.      The goal was to evaluate prospectively and consecutively the presence of epithelioid     granulomas in salivary glands biopsy of patients with TB.   "
89512|NCT02114632|"     The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in     boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy     boys.   "
89405|NCT02115841|"     Noninvasive brain stimulation was recently gradually be emphasized. The electrical current     applied on scalp can effective modulate cortical excitability. Forms of Stimulation included     transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS).     tDCS had been proved the effect of cortical excitability modulation. The polarization effect     of direct current stimulation can modulation specific brain area and enhance motor     performance. tACS was still controversial about the effect on cortical excitability. Previous     study show that the frequency dependent excitatory or inhibitory effect on cortex. The     possible mechanism was to affect brain oscillation status by provided different frequency of     stimulation. Transcutaneous nerve stimulation (TENS) was common used on management of chronic     pain. Peripheral nerve stimulation can enhance pain or sensory evoked potential was noted.     Effect of low frequency TENS on central nervous is unknown.   "
89406|NCT02115828|"     This is a single-arm pharmacodynamic study with mandatory metastatic tumor biopsies in men     with castration-resistant prostate cancer.      The trial will evaluate the effect of vismodegib on tumor tissue in men with metastatic CRPC     by obtaining tumor biopsies at baseline and after 4 weeks of treatment with vismodegib.   "
89407|NCT02115815|"     The purpose of this study is to determine if the administration of single ascending     intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in     adults 60 years or older who are healthy or who have stable, chronic underlying medical     conditions.   "
89408|NCT02115802|"     The purpose of this study is to record electrical brain activity during DBS surgery and after     DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified     DBS pulse generator. The goal of the study is to investigate if the electrical brain activity     can help customize DBS therapy.   "
89427|NCT02115555|"     The study will compare three treatment strategies to look at the best clinical outcomes.      The investigator hypothesizes that the combined approach of a health information technology     program plus a conflict-management contract will lead to the best outcomes.   "
89410|NCT02115776|"     The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin     (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a     chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental     extractions.      The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show     higher effectiveness in reducing the prevalence and duration of bacteremia following dental     extractions, than that achieved with the classical amoxicillin regimen.   "
89411|NCT02115763|"     Caffeine has been shown to consistently improve time-trial performance, warranting     restrictions on consumption under regulation of the National Collegiate Athletics Association     (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood,     possibly occurring as a result of altered metabolism, improved strength, and/or reduced     muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while     muscular strength has a tenuous relationship with endurance exercise performance. Reductions     in muscle pain have been observed during low and moderate intensity endurance exercise, and     this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during     high intensity exercise, caffeine significantly improves performance. Therefore, caffeine     appears to improve the amount of work that can be done for a given muscle pain rating,     suggesting that participants may pace based upon sensations of muscle pain during endurance     exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the     time it takes participants to cover a given distance. Little research has been conducted on a     fixed pain time-trial that would require participants to produce and sustain a given level of     muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial     could allow researchers to better understand the effect of pain on endurance performance. The     purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.   "
89412|NCT02115750|"     This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid     arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic     therapies.      Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center     global study. The primary end point is 20% improvement in American College of Rheumatology     criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.      Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response     receive CHS-0214. Continued response and safety will be evaluated.   "
89413|NCT02115737|"     Youth with depressive symptoms are at risk for a range of problems later in life. This     includes problematic interpersonal relationships, occupational stress, and the occurrence of     adult mental disorders. The main purpose of this study is to test how effective two types of     group therapy are at reducing depressive symptoms in youth. A focus on group therapy is     important because group therapy allows for many youth to be treated in a short amount of     time. Group therapy is also helpful because youth can get social support and feel less alone     in their symptoms when they participate in group. This study compares two groups, one that     targets skills for managing difficult emotional experiences (dialectical behavior therapy     skills group) and another group focuses on psychoeducation and is based on a publicly     available treatment manual from the Services for Teens At Risk (STAR) Center at the     University of Pittsburgh. The results of this study will provide insights regarding the     comparative efficacy of these two treatments, and regarding predictors of treatment response.   "
89414|NCT02115724|"     Cardiovascular disease is the leading cause of death in the United States. Other studies have     shown that stress, early in life, could be a risk factor for cardiovascular disease, later in     life. This study will look at the effect of early life stressors on your cardiovascular     health.   "
89437|NCT02114463|"     Pain after amputation is a significant problem among amputees. Phantom limb pain may appear     in up to 85% of patients and is usually resistant to a wide variety of treatments.It is     believed that regional anesthesia, by preventing the establishment of central sensitization,     may play a role in reducing the incidence of acute and chronic pain. Therefore the     investigators will compare two methods of postoperative analgesic after after amputation by     their efficiency and complication.   "
89415|NCT02115711|"     The study is a 2 year community based cluster randomized controlled trial to assess the role     that a community health worker led intervention, in concert with physician education, can     play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco     use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include     around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola,     Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community     health worker based approach can result in increased control of Hypertension, Diabetes and     Smoking.   "
89416|NCT02115698|"     Up to 66 healthy elderly individuals (at least 65 years old) are recruited as subjects. They     will be recruited as a subgroup to protocol ID: H-4-2013-070.      Upon inclusion, each individual will be randomized into one of the five groups stratified     according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy     Resistance Training (N=12), Light Intensity Training (N=12), Protein Whey (N=15), Protein     Collagen (N=15) and Carbohydrate (N=12). The individuals randomized into one of the     supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to     the supplement content.      Assessments will be performed at Baseline (before intervention start) and after 12 months of     intervention.      The primary outcomes are measures of muscle protein synthesis rate measured as the fractional     synthesis rate from Baseline to 12 months of intervention.      The hypotheses are i) that basal and protein-stimulated muscle protein synthesis rates are     elevated in the exercise training groups after 12 months of intervention. ii) prolonged     intake of protein of different quality will improve the muscle protein synthetic response to     protein intake after 12 months of intervention.   "
89428|NCT02115542|"     The main purpose of this study is to see if regorafenib can help control or decrease cancer     size in patients with cancer of the bile duct. Researchers also want to find out if     regorafenib is safe and tolerable.   "
89561|NCT02113813|"     The purpose of this study is to assess the safety and tolerability of ASP8273 and to     determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). This study     will also determine the pharmacokinetics (PK) of ASP8273, evaluate the potential inhibition     of CYP3A4 by ASP8273 and the antitumor activity of ASP8273 as well as determine the effect of     food on the bioavailability of ASP8273.   "
89417|NCT02115685|"     Significance: The long term objective of this study is to improve physical therapy and     fitness programs in people with spinal cord injury. The results of the study will demonstrate     the importance of matching blood flow to a muscle with exercise of that same muscle.      Scientific Objective: The objective of the study is to measure how the body regulates     bloodflow to a muscle during exercise. We intend to study these effects by triggering blood     flow changes during movement, and measuring bloodflow changes during exercise in people with     spinal cord injury. We will also look at the long term effects of different exercise programs     on bloodflow during exercise.      Study Populations: This study will involve people with partial spinal cord injury and age and     sex matched controls without injury.      Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the     injury). This aim will examine the control of bloodflow and muscle contractions and how it     changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during     exercise after training. Three different eight week exercise training programs will be tested     including 1) upper body ergometry, 2) treadmill training with exertion level matched to the     upper body ergometry and 3) treadmill training with heart rate matched to an initial test of     upper body ergometry.   "
89418|NCT02115672|"     The aim of the study is to test the safety and efficacy of BL-8040 (a CXCR4 antagonist) in     improving the response to imatinib in CML patients not achieving an optimal response with     imatinib alone.   "
89419|NCT02115659|"     Triptolide was shown in experimental studies to inhibit the cyst formation and growth in     ADPKD models, while triptolide-containing formulation was revealed to potentially slow the     disease progression in several proteinuric ADPKD patients in our clinical practice. It     remains to be shown the effect of triptolide-containing formulation on total kidney volume     (TKV) enlargement and renal function protection in ADPKD patients.   "
89420|NCT02115646|"     The investigators are studying the appearance and function of burn scars after treatment with     fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance     and range of motion will improve with treatment.   "
89421|NCT02115633|"     The overall goal of this project is to continue development and commercialization of a     Wearable Sensory Prosthesis termed Walkasins. The device measures foot pressure through a     thin sole insert, developed under recent Phase I funding, and displays pressure information     through a vibrotactile feedback array, placed around the lower leg, to help improve balance     function. The device can replace lost foot pressure sensation in individuals with peripheral     neuropathy who have balance problems. Our specific aims are to:        1. Revise and finalize design of Walkasins™ based on accomplishments, user input, as well          as reviewer criticism from our Phase 1 grant and manufacture 200 units of the device for          clinical testing.           Milestone 1: 200 units manufactured and ready for clinical testing under Aim 2. This          goal is accomplished.        2. Investigate effects of using Walkasins on clinical outcomes related to gait, balance          function and associated fall risk in a population of patients with sensory peripheral          neuropathy and balance problems.      Hypotheses 1A-B: Patients who are trained to use Walkasins programmed to display relevant     balance cues will attain higher gait speed and Functional Gait Assessment when compared to a     matched cohort not using Walkasins.      Milestone 2: Data confirming the clinical utility and safety of the Walkasins on patients who     are trained to use the device.   "
89422|NCT02115620|"     The purpose of this study is to see if telemedicine can help improve the health of patients     with heart failure who have recently been hospitalized with heart problems, and are being     discharged to a Skilled Nursing Facility. Telemedicine uses electronic communications to make     patient/doctor visits possible from a distance.      This study will use remote video to allow heart failure specialists at Providence St. Vincent     Medical Center to provide clinical health care to patients at Marquis Hills. Electronic     monitors (including an electronic scale and blood pressure machine), and phone calls with the     Marquis Hill nursing staff will be used to track patients' health status. The nursing staff     will provide the heart failure specialists with daily updates on patients' symptoms, weight,     vital signs (heart rate, blood pressure, pulse), and results of blood tests.      Additionally, some patients will be provided with monitoring devices that include an iPhone     blood pressure monitor, and Smart Body Analyzer to use for 14 days. The Smart Body Analyzer     measures weight, body fat percentage, and heart rate. It also measures indoor air quality.     Special software on the iPhone will save this information and the information will be     transmitted by secure email to the study doctors.      Hypothesis: The patients followed by telemedicine will have fewer visits to the Emergency     Department, fewer deaths, and fewer hospital re-admissions than last year's site-specific     average for this patient population.   "
89423|NCT02115607|"     This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques,     quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE),     used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging,     Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and     interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant     chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the     neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant     chemotherapy treatment. Results will be compared to MRI and pathology.   "
89424|NCT02115594|"     Preclinical data has demonstrated that entinostat (SNDX-275) can enhance fulvestrant     sensitivity in hormone receptor-positive breast cancer in animal models. The addition of     entinostat to fulvestrant will provide clinical benefit to patients with locally advanced or     metastatic breast when compared to fulvestrant plus placebo. Also, based on previous data,     patients exposed to entinostat who demonstrate an elevated level of protein lysine     acetylation will have an improved efficacy outcome.   "
89425|NCT02115581|"     This study aims to determine the effect of Coenzyme Q10 supplementation on conventional     therapy of children with heart failure due to idiopathic dilated cardiomyopathy.   "
89426|NCT02115568|"     This is an exploratory registry that will include subjects who have been randomized to     receive JVS-100 treatment (at one of multiple doses) or placebo by one of a number of     delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous Juventas     clinical trial.   "
89449|NCT02114307|"     To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in     treating patients with venous insufficiency.   "
89429|NCT02115529|"     Untreated, one third of patients undergoing general anesthesia will have postoperative     nausea, vomiting, or both.      Patients often rate postoperative nausea and vomiting (PONV) as worse than postoperative     pain. PONV increases the risk of aspiration and has been associated with suture dehiscence,     esophageal rupture, subcutaneous emphysema, and bilateral pneumothoraxes. PONV frequently     delays discharge, and is the leading cause of unexpected hospital admission after planned     ambulatory surgery.      Nabilone (Cesamet®) is a synthetic cannabinoid developed in the 1970s which is a potent CB1     agonist. The use of nabilone in preventing nausea and vomiting in patients receiving     chemotherapy has been thoroughly investigated. Results from clinical studies demonstrated the     efficacy, safety, and tolerability of Cesamet in this population. There has been success in     the past translating treatments for chemotherapy-induced nausea and vomiting (ie. 5-HT     receptor agonists including Ondansetron and Granisetron) to use in the perioperative     environment.      Only one RCT has studied the use of nabilone for the reduction of PONV. Published in 1995,     this study compared the administration of either Cesamet 2 mg or metoclopramide 10 mg given     90 minutes before the operation in patients scheduled for elective hysterectomy in 60 women.     This study failed to show any significant difference between groups. There are several     limitations to this study including a poorly optimized dosing regimen, a small sample size,     and a comparison group lacking clinical generalizability.      This study will investigate the use Cesamet vs Placebo, in addition to the regular antiemetic     treatment which patients receive at the discretion of the managing anesthesiologist, for the     prevention of PONV. The study group will include patients undergoing general anesthesia for     elective ambulatory surgery with at least 3 risk factors (>60% risk) for the development of     PONV.   "
89430|NCT02115516|"     TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ     Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled     human malaria infection (CHMI).   "
89431|NCT02115503|"     The purpose of this treatment registry study is to determine if monthly infusions of     Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that     are thought to be responsible for chronic rejection episodes in renal transplant subjects.     162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months and be     followed for 3 years.   "
89432|NCT02115490|"     Osteoporosis is a public health problem. It is a skeletal disease being treated by     Bisphosphonates as the first choice medication. The effects of these drugs were investigated     for periodontal disease treatment both locally and systemically. However, it is very     important to know their indirect effects on alveolar bone (i.e. their effects when used for     treating osteoporosis). So, in this study, alternations that involve the alveolar bone when     osteoporotic women use bisphosphonates will be studied radiologically using cone-beam CT and     digital panoramic radiography. The goal is to provide dentists with information about changes     in the characterization of the alveolar bone among these women. This is important for both     periodontology and implantology. Maxillary and mandibular bone structural characterization     among osteoporotic women had not been studied before. Furthermore, in an opposite direction,     dental radiographs may aid in detecting osteoporosis.      Osteoporotic women, under bisphosphonates therapy or not, will be invited to participate in     this study. In addition, osteopenic and normal women regarding bone fragility will be     included too, for comparison purposes. Panoramic radiographs will be taken. In addition,     women under bisphosphonates for 6 months or more will be scanned by Cone -beam CT as it can     give an idea about bone histomorphometry with a low radiation dose.   "
89433|NCT02115477|"     The purposes of this study are        -  to determine the prevalence, size and impact on quality of life of lymphedema of the          lower extremities after primary radical surgery with hysterectomy +/- pelvic - and          paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO          (International Federation of Gynecology and Obstetrics) stage 1 and 2        -  to analyze risk factors for development of lymphedema in this specific group of          patients.      Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema,     subjectively and objectively, and have an impaired quality of life.      This is a Swedish multicenter study carried out in 17 departments of Obstetrics and     Gynecology and in 3 departments of Oncology. All participants are treated according to the     Swedish National Guidelines for Endometrial Cancer.      130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk     endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy without     lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the study.      The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6     weeks , 6 months and 12 months postoperatively.      Determination of occurrence of lymphedema of the lower extremities are determined objectively     by 1) a standardized clinical evaluation according to Bruna et al.[1] and 2) determining the     leg volume according to the cone model by Sitzia [2] by systematically measuring of leg     circumferences. In addition, occurrence of lymphedema is measured subjectively by the     participants.      On the same four occasions as the leg circumference measurements are conducted the patients     complete two generic health related quality of life forms (the EuroQol EQ-5D and the     Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema     (LYMQOL).      Demographic and clinical data are systematically collected until one year postoperatively     including occurrence of complications and given adjuvant oncological therapy such as chemo-     and radiation therapy.      On each occasion of clinical control a vaginal ultrasound examination is carried out in order     to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion     intraabdominally.   "
89438|NCT02114450|"     This research study will investigate the use of smart lower limb robotic exoskeleton     (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare     robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also     examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain     wave patterns associated with learning to walk on the powered lower limb exoskeleton. The     findings will be used to understand human-robot interaction and to design smart orthotic     devices that can be controlled by thought activity and assist those that have lost all or     part of their walking abilities.   "
89439|NCT02114437|"     Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of     Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it     difficult to judge the depth of anesthesia according to traditional hemodynamics index such     as heart rate and blood pressure.In case of this, the investigators design this research to     study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided     by a Narcotrend index monitor in Laparoscopic Cholecystectomy.   "
89440|NCT02114424|"     POSAS can be treated with CPAP however there is now evidence from a few studies that Night     Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we     would like to examine if we could find similar results in routine clinical work and     especially we would like to confirm the subjective effects with objective measures i.e. a     reduction in AHI in the supine position during sleep.   "
89450|NCT02115438|"     Occupation stress can be the risk factors of early embryonic death   "
89451|NCT02115425|"     The purpose of this study is to collect body composition data using bioimpedance analysis     (Samsung) and DXA (GE Medical). Both of the methods are explained in more detail in section 5     of this consent. The data collected will help Samsung improve the products the company     offers.   "
89562|NCT02113800|"     The study is designed as an open-label, prospective, single arm, multicenter study of     everolimus in histologically confirmed, neuroendocrine carcinoma G3 /neuroendocrine tumor G3     after failure of first-line platin-based chemotherapy (open-label pilot study).      The aim of this study is to provide a second line therapy to patients with any type of     platinum based first line chemotherapy, to gather data on disease control rate and     progression free survival.   "
89441|NCT02114411|"     Background: Atrophic gastritis (AG) is the single most important precursor condition for     gastric cancer (GC) known so far. H. pylori infection is the most important causative agent     of gastritis, and subsequent AG. The GastroPanel test (Biohit HealthCare, Helsinki, Finland),     a blood test evaluating the four biomarkers specific for the gastric mucosa pepsinogen I     (P-PGI), pepsinogen II (P-PGII), gastrin-17 (P-G-17) and H. pylori antibody (P-HpAb), is the     first non-invasive diagnostic tool providing possibilities for detecting the patients at risk     for GC and peptic ulcer as well as malabsorption of vitamin B12, iron, magnesium, calcium and     some drugs. A well designed clinical study is warranted to fully assess the performance of     GastroPanel examination in detecting the gastric lesions which can lead to GC. The     investigators aim to perform a clinical study in an adult population in United Kingdom in     order to determine the diagnostic accuracy of the GastroPanel test in evaluating AG and other     specific gastric conditions associated with an increased risk for GC. Methods: Two hundred     and fifty patients (45 years and older, both genders) will be enrolled among the patients     with dyspepsia referred for gastroscopy at Homerton University Hospital (London, United     Kingdom). During the same visit, all patients are subjected to gastroscopy examination, with     directed biopsies from the antrum and corpus, following the protocol of the operative link on     gastritis assessment (OLGA) classification for chronic gastritis and Sydney Classification.     Biopsies are examined at the Pathology laboratory of Homerton University Hospital and     interpreted using the OLGA staging system as well as the Sydney system for classification of     gastritis. Specific aims: The principal goal of this clinical trial is to establish the     performance of the GastroPanel examination in detecting AG and other specific gastric     conditions associated with an increased risk for GC. In particular, the investigators will     evaluate AG in the antrum, AG in the corpus, AG in both antrum and corpus (=atrophic     pangastritis), biopsy-confirmed dysplasia (intestinal metaplasia) of the gastric mucosa. For     all these conditions, the investigators will calculate the diagnostic accuracy of the     GastroPanel test.   "
89442|NCT02114398|"     The study aim is to compare usual asthma crisis treatment of hospitalized children with usual     treatment associated to sophrology.   "
89443|NCT02114385|"     Primary objective      To demonstrate that administration of the 9vHPV vaccine induces non-inferior Geometric Mean     Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to     26-year-old men   "
89444|NCT02114372|"     The purpose of this study is (i) Main Study: To describe the baseline characteristics     (including demographics, cognitive status, and other measures) and the cognitive and     functional changes of persons at risk for developing Alzheimer's disease (AD).      (ii) SubStudy: To investigate the longitudinal change of the components of the Preclinical     Alzheimer Cognitive Composite (PACC) and the components of the Repeatable Battery for the     Assessment of Neuropsychological Status (RBANS) in asymptomatic at risk for AD (ARAD)     individuals compared with individuals not classified as ARAD.      (iii) Neurovision Ancillary Study: To explore correlation between retinal amyloid beta     plaques identified by fluorescence with amyloid positron emission tomography (PET)     Standardized Uptake Value Ratio (SUVR) and cerebrospinal fluid (CSF) amyloid beta 42 testing     in participants at risk for Alzheimer's dementia.   "
89445|NCT02114359|"     The investigators compare the overall survival between combination chemotherapy and     monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or     recurrent gastric cancer. The investigators also compare the progression free survival,     response rate, safety, and, quality of life between two groups, and evaluate that the     comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance     of treatment, survival of the patients.   "
89446|NCT02114346|"     The aim of this study is to determine the efficacy of atorvastatin in the prevention of     contrast-induced nephropathy in patients undergoing computed tomography coronary angiography.     Investigators assume that atorvastatin is effective in this regard. Investigators include     patients referring for elective computed tomography coronary angiography and allocate them to     atorvastatin or placebo from 24 hours before to 48 hours after administration of contrast     material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL     or ≥ 25% of the baseline value.   "
89447|NCT02114333|"     This study will compare the two vaccines that have been developed to prevent and/or lessen     the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other,     herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an     ingredient that may enhance the body's immune response to the vaccine, and is currently     investigational. The vaccines are being compared to assess their ability to stimulated     protection against shingles. The study will provide an opportunity to determine the safety     profile of each vaccine in a single trial. The study will also look at the effect of age on     the immune response to the two vaccines and on the persistence of these responses.   "
89462|NCT02115282|"     This randomized phase III trial studies exemestane and entinostat to see how well they work     compared to exemestane alone in treating patients with hormone receptor-positive breast     cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen     can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight     breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet     known whether exemestane is more effective with or without entinostat in treating breast     cancer.   "
89848|NCT02110043|"     The aim of this study is to investigate whether a combination of intensive training of     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation     (tDCS) leads to an improvement in learning and memory in patients with mild cognitive     impairment (MCI) and to examine the underlying neuronal mechanism.   "
89448|NCT02114320|"     Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful in     patients with malignant biliary obstruction, selective biliary cannulation fails in some     cases and conventional ERCP may not be possible in patients with tumor invasion of the     duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or     complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage     (PTBD) is an useful alternative. However, PTBD had various complications and the presence of     an external drainage catheter would also have a cosmetic problem related to the external     drainage and an adverse impact on quality of life (QOL) of terminally ill patients.      Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case     reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and     effective alternative in patients with failed conventional ERCP stenting. The potential     benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for     avoiding long-term external drainage in cases where external PTBD drainage catheters cannot     be internalized, thus significantly improving the QOL of terminally ill patients, and     possibly lower morbidity than PTBD or surgery.      Up to date, only a few case series of EUS-BD with small numbers of patients have been     published, and known the feasibility and safety in terms of the incidence of     procedure-related clinical outcomes.   "
89563|NCT02113787|"     The purpose of the study is to prove the bioequivalence of brand and generic topiramate.   "
89452|NCT02115412|"     Research has shown that nearly 50% of patients with chronic conditions around the globe do     not adhere to their prescribed medicine, leading to enormous cost to the healthcare     providers. Non-adherence can be due to various forms and have multiple causes.      To address this need, Philips Research has developed Medication Non-adherence model. This     tool will help in developing a systemic way of assessing medication non-adherence and     providing decision support for targeted intervention to healthcare professionals. The aim of     this study is to validate this model with 750 chronically ill patients in UK.   "
89453|NCT02115399|"     The purpose of this study is to look at how defects in the skin barrier and immune response     affect risk for skin infections.      Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA)     status and Staphylococcus aureus (S. aureus) colonization (negative or positive):        -  AD S. aureus negative        -  AD S. aureus positive        -  NA S. aureus negative and        -  NA S. aureus positive.   "
89454|NCT02115386|"     Primary Objective for this study is to evaluate changes in chronic low grade     non-hematological adverse events experienced by patients who have been treated with at least     6 months of imatinib and who have not responded to supportive measures, when they are     switched to nilotinib (CTCAE grading system).   "
89455|NCT02115373|"     This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and     pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced     hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed     sorafenib treatment.   "
89456|NCT02115360|"     A prospective randomized double-blind clinical trial design will be used in a cohort of sixty     patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and     II who will undergo lower limb amputation, will be enrolled into the present study. Patients     will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC)     Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.   "
89457|NCT02115347|"     This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835,     PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1     of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and     matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be     conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).   "
89458|NCT02115334|"     Early intervention refers to the provision of early detection, early diagnosis, and early     intervention for infants and young children with special needs. The implementation of home     programs is very important for children with developmental delay (DD). Therefore, the     purposes of this study are to: (1) design the preschool home program activities(PHPA), (2)     investigate the immediate efficacy of PHPA for children with DD, (3) investigate the     long-term efficacy of PHPA for children with DD.The second year is to investigate the     immediate efficacy of PHPA for children with DD.   "
89459|NCT02115321|"     This study is being done to evaluate the efficacy and safety of the drug combination     grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C     virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP)     score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the     percentage of HCV-infected participants with hepatic insufficiency (the CP-B population)     achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will     be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will     also be given GZR + EBR at the beginning of the study; this will be done for the purpose of     collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have     hepatic insufficiency.   "
89460|NCT02115308|"     The purpose of this study is to measure the changes in cardiac function during a Lexiscan     pharmacologic stress test using cardiac magnetic resonance imaging test.   "
89461|NCT02115295|"     The goal of this clinical research study is to learn if the combination of cladribine,     idarubicin, and cytarabine can help to control AML, high risk MDS, and/or CML in blast phase.     The safety of these drugs will also be studied.   "
89486|NCT02114970|"     The investigators will develop and test a tablet-delivered informed consent process. In a     preliminary phase of the study, older adults will provide feedback on a prototype     tablet-delivered consent by participating in a focus group. In a separate second phase, older     adults will be randomly assigned to a tablet-delivered or paper-delivered consent condition     in which their comprehension of material covered in the consent will be assessed.   "
89463|NCT02115269|"     Headaches are a common medical problem that physicians frequently encounter in their     practice. One of key findings of The Atlas of Headache Disorders prepared by World Health     Organization (WHO) is: headache disorders, including migraine and tension-type headache     (TTH), are among the most prevalent disorders of mankind. The fixed combination of     indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute     treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is     widely used in common daily practice only in Italy from early 1970s, is available at the     Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data     regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing     observational study which aimed to evaluate the effectiveness and patients' satisfaction of     primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.   "
89464|NCT02115256|"     Breech presentation of a term pregnancy is a common occurrence. A procedure known as external     cephalic version (ECV) is frequently used by obstetricians to turn the baby into the vertex     position prior to delivery in order to avoid a cesarean section and the associated risks.     Medications to relax the uterus, known as tocolytics, are used in conjunction with the     procedure as they have been shown to improve the success rate of ECV, but with inconsistent,     varying results.   "
89465|NCT02115243|"     The purpose of this study is to determine safety profile, initial response rates and     progression free survival for the combination therapy of neoadjuvant system ipilimumab     followed by ILI with melphalan in patients with in transit melanoma.      Hypothesis:      The combination of regional LPAm plus systemic ipilimumab will lead to a larger response rate     than either therapy alone.      The combination of regional LPAm plus systemic ipilimumab will cause larger changes in immune     cell populations than are seen with either therapy along.      Changes in immune cell populations will predict progression free survival.   "
89467|NCT02115217|"     Ankles sprains are the most popular injuries in basketball players. They are traumatic     injuries, which happen most of the time in specific situations, like landing on another     player's foot, or during changes of direction.      Neuromuscular exercises are very important to improve ankle stability and reduce risks of     sprains. However various external support such as ankles braces and rigid tape, are also used     in order to prevent injury.      The kinesiotape (KT) is a new but broadly used method in the world of athletes. Created by     KenzoKase, in 1980, this kind of tape has a tremendous success with athletes and is today     commonly used during practices and/or competitions. The main property of this tape is its     elasticity, which is supposed to improve proprioception and, thus ankle stability, but these     aspects have not been investigated yet.   "
89468|NCT02115204|"     Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer     (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German     Study Group and Arbeitsgemeinschaft Gynäkologische Onkologie (WSG-AGO) EC-Doc is a large     trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3     involved lymph nodes (LN).   "
89469|NCT02115191|"     Urethrocutaneous fistulae (UCF) represent one of the most frequent causes of morbidity after     urethroplasty. Hypospadias can be repaired using different surgical techniques, but     regardless of technique, the incidence of UCF ranges between 10% and 40%. The surgical repair     of UCF remains the treatment of choice, even if some patients need further operations because     of recurrences. The cyanoacrylates have been used as skin suture substitutes, and some     evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the     management of UCF.   "
89470|NCT02115178|"     Background and Goal of Study: Minimal dose of spinal hyperbaric bupivacaine is commonly     performed for adult anorectal surgery. This kind of anaesthesia can cause sinus bradycardia     and hypotension wich reason is body position, autonomic nervus system reaction, reflex     reaction even with low levels of sensory block. However, neither the publication of minimal     doses of spinal hyperbaric bupivacaine effects of haemodynamic modifications nor their     accuracy was widely discussed. The aim of the study is to make a comparison of the     haemodynamic modifications due to minimal dose of spinal hyperbaric bupivacaine for adult     anorectal surgery in lithotomy or jack knife position of steering impedance device.      Materials and Methods: Patients will be included which are over then 18 years old, who     underwent anorectal surgery of the benign pathology, requiring spinal anaesthesia, were     admitted in this clinical randomized study, hospitalized in Hospital of Lithuanian University     of Health Sciences Kaunas Clinics and agree to participate to this study (written     settlement). All patients were implicitly divided in to 4 groups by the position will be     operating (lithotomy or jack knife position and by American Society of Anaesthesiologists     (ASA) clas I-II and III-IV). Technique of anaesthesia were strictly standardized by protocol.     All patients were premedicated with oral diazepam 5mg and diclofenac 100mg 60min before     operation. After arrival in the operating theater peripheral vein 18 or 20G catheter was     inserted, infusion therapy were started with crystalloid 5-7ml/kg/hour. Standard monitoring     was used, including noninvasive arterial blood pressure (BP), electrocardiography (ECG),     heart rate, peripheral oxygenation. Circulatory changes were recorded impedance device. 2     single-neck sensors connected vertically on both sides of the neck just below the ears lobe.     Another pair of sensors attached on both sides of the chest processus xiphoid axillary line     level. Thorax allows a variable electrical current, it travels through the lowest resistance     (blood-filled aorta) and resistance is measured. For each heart contraction during changes in     blood volume and velocity. Accordingly, replacing the resistors obtained by impedance     settings.      Haemodynamic variables were recorded in patients in the use of impedance cardiograph:        1. arrives in the operating room;        2. seating on the operating table;        3. following the puncture;        4. 10 min after spinal puncture;        5. was laid in lithotomy or jack knife position;        6. in the beginning and the end of the operation;        7. patient was placed in the bed.      Each measurement was monitoring and recorded the following data( ar findings):        -  Cardiac output (CO);        -  Systemic vascular resistance (SVR);        -  Systolic index (SI)        -  Cardiac index (CI);        -  Acceleration index (ACI);        -  Heart rate (HR);        -  Non-invasive systolic (SAP), diastolic (DAP) and mean (MAP) blood pressure;        -  Peripheral oxygenation (SpO2); Patients were placed in the sitting position on the slab          (operating table) back to the doctor. Dural puncture was made at L3-L4 or L4-L5 with 27G          Tamanho spinal needle ( BBraun, Germany) by medial punction in aseptic condition, before          the punction was injected lidocaine 1% subcutaneous. 0.5% 4mg of heavy bupivacaine and          0.01% 10µg fentanyl were injected over 2 minutes after free flow of cerebrospinal fluid          was obtained. After sitting for 10 minutes ( sensory block was checked by the dermatomes          with the methods of cold sensitivity) patients were asked to lie in the position wich          operation will be done (lithotomy or jack knife position).      After 20 min. surgery was started. When anaesthesia was imperfect, 25-100µg of fentanyl was     given IV. General anaesthesia will be give in case of failure . These cases will be value     like a failure, patients will be exclude from the study.      Clinically significant hypotension will be define as a mean arterial blood pressure and heart     rate decrease of 20% below baseline values. Systolic arterial blood pressure will reduce to     90mmHG limit, intravenous ephedrine 5-10 mg will be injected. If heart rate will reduce to 45     bpm, bradycardia will be treated with atropine 0,5 mg IV.   "
89471|NCT02115165|"     Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing     and limited peripheral neuro-toxicity, two major potential advantages in patients with     advanced NSGCTs.      Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have     demonstrated activity in pre-treated GCTs and are now part of standard treatment, but     cabazitaxel has not yet been tested in patients with NSGCT.   "
89472|NCT02115152|"     This randomized phase II trial compared pathologic response rates (pCR) of early breast     cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and     capecitabine-epirubicin-cyclophosphamide (XEC).   "
89473|NCT02115139|"     Ipilimumab adds a clinical benefit to radiation therapy in patients with melanoma metastatic     to the brain.      Melanoma is the third most common cancer causing brain metastases, after cancers of the lung     and breast, which appears to reflect the relative propensity of melanoma to metastasize to     the central nervous system (CNS). Brain metastases are responsible for 20 to 54 percent of     deaths in patients with melanoma, and among those with documented brain metastases, these     lesions contribute to death in up to 95 percent of cases, with an estimated median overall     survival ranging between 1.8 and 10.5 months, depending upon other prognostic factors.      Ipilimumab is an anti-Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) monoclonal antibody that     has demonstrated a clinically relevant and statistically significant improvement in overall     survival, either alone (second line) or in combination with dacarbazine (DTIC) in 1st line.      Ipilimumab has shown activity against brain metastases.      According to the European Medicines Agency (EMA) approved label for Yervoy®, the use of     glucocorticoids at baseline (commonly prescribed when brain metastases are diagnosed) should     be avoided before the administration of ipilimumab. Data show that the use of even high doses     of glucocorticoids for the management of immune-related adverse events do not decrease the     efficacy of Yervoy®. There is no documented experience on the efficacy of Yervoy® when given     concomitantly with radiation therapy and glucocorticoids.      In experimental models, radiation therapy is synergistic to anti-Cytotoxic T-Lymphocyte     Antigen 4 (anti-CTLA4) strategies (abscopal effect).      There are no published results from clinical trials on the interaction between radiation     therapy and ipilimumab.   "
91031|NCT02094560|"     To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate and     rate of disease stabilization, as defined by the below primary and secondary endpoints, in     patients with NSCLC, SCLC or biliary cancer who have progressed despite one or more previous     chemotherapy line.   "
89474|NCT02115126|"     This is a non-blinded, not placebo controlled, randomized, parallel phase 2 pilot study to     evaluate the immunological response and the safety of Epstein Barr Virus (EBV)-derived tumor     antigen, Latent Membrane Protein-2 (LMP2)-loaded dendritic cell (DC) vaccines alone or     co-administered with the TLR9 ligand, DUK-CPG-001, in patients with EBV+ lymphoma in the     setting of autologous stem cell transplant with infusion of mature T cells. Patients will be     randomized to receive vaccine alone or vaccine co-administered with the TLR9 ligand,     DUK-CPG-001. Randomization will be stratified by 2 disease types: Hodgkin lymphoma and     non-Hodgkin lymphoma.   "
89475|NCT02115113|"     The purpose of this study is, starting from the Italian clinical practice in liver     transplantation, to optimize the immunosuppressive therapy, considering specific patient     characteristics as alcoholic cirrhosis, hepatitis C virus (HCV), hepatocellular carcinoma     (HCC), and short/long-term implications. Then efficacy and safety of a calcineurin inhibitor     (CNI)-withdrawal regimen will be evaluated in comparison with a CNI-minimization regimen.   "
89476|NCT02115100|"     Prospective, randomized, controlled, multicenter, international clinical trial. The study     population consist of patients with paroxysmal or persistent atrial fibrillation with out     range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of     the following two groups.      group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo     pulmonary vein isolation and renal artery denervation.   "
89477|NCT02115087|"     The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block     (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.   "
89564|NCT02113774|"     The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal     transplant patients does not have impact on the development of symptomatic urinary tract     infection (UTI) or progression of renal impairment in patients during the first year after     transplantation.   "
89565|NCT02113761|"     RATIONALE / CONTEXT The ECG records the electrical activity propagating along cardiac cells     (from the atria to the ventricles). The standard 12 ECG leads placed on the chest measure the     global activation of the heart and do not have the ability to detect small-scale disturbances     or to pinpoint ectopic activity. By the 1960s, multiple electrodes were placed around the     chest to try to understand the complexity of the distribution of electrical activity in     relation to the single cardiothoracic geometry of each individual. The safety of this method     is similar to the ECG but its superiority has been demonstrated by the detection of anomalies     imperceptible to the standard ECG. The accuracy of the technique in localizing rhythm     disturbances is on the order of 5 mm.      OBJECTIVES Main objective: To evaluate the utility of noninvasive mapping during persistent     AF electrophysiology procedure      Secondary objectives:        1. Compare the effectiveness of noninvasive mapping compared to conventional standard of          care methods for AF mapping and ablation procedure.        2. Evaluate the absence of recurrence of persistent AF after a follow up of 12 months after          the procedure during a scheduled hospitalization.      DIAGRAM OF RESEARCH European Diagnostic Study, feasibility, non-randomized, multi center      RESEARCH PROCEDURES A trained clinical specialist places 252 dry gelled ECG electrodes on the     patient's torso. The 252 ECG electrode array is hooked up to the CardioInsight system and     body surface ECG recordings are made during the patient's arrhythmia. The patient is then     sent to the radiology department for a CT scan (no contrast) to image both the heart and     electrodes on the patient's torso. A trained clinical specialist from CardioInsight then     segments the CT DICOM images from the CT scan to obtain epicardial anatomy and establish     heart-torso geometry.      The electrograms are processed by the system to produce movies of fibrillatory activity (both     focal activity, and rotor activity).      PROCEDURAL ENDPOINTS Primary endpoint: Acute AF termination to atrial tachycardia or sinus     rhythm      Secondary outcome criteria:        -  Reduction in RF time compared to standard of care (historical control - comparable          patient population)        -  Reduction in procedure time compared to standard of care (historical control -          comparable patient population)        -  Freedom from persistent AF at the end of the 12 months F/U period STUDY SIZE      The sample size was estimated at 100 patients, with up to 20 patients per center STUDY     CENTERS 8 Centers :        -  Brugmann - Brussels (Belgium)        -  Clinique Pasteur - Toulouse (France)        -  Medizinische Klinik und Poliklinik - Mainz (Germany)        -  University ed Herzzentrum Freiburg Bad Kozingen (Germany)        -  Deutsches Herzzentrum München, Munich (Germany)        -  Kerkhoff Klinik, Bad Nauheim, (Germany)        -  Sint-Jan Sint-Franciscus Xaverius, Brugge (Belgium)        -  Clinique Ambroise Paré, Paris, France      EXPECTED OUTCOME In patients referred for ablation of persistent AF, ECG mapping data will be     correlated to the invasive procedure. It is expected that procedure time will be     statistically shorter and total RF energy delivery is expected to be smaller than that of     standard of care for AF treatment.   "
93307|NCT02064751|"     The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing     (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in     patients receiving cardiac resynchronization therapy (CRT).   "
89478|NCT02115074|"     Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a secondary     role. Unlike other sites, many of these tumors are not amenable to complete resection either     because of anatomical location, and sometimes they only can be biopsied. A substantial number     of children will have recurrences following resection or will experience progression     following incomplete tumor removal or biopsy.      Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins     are known to increase the sensitivity of gliomas to anti-tumor agents. Their association     could be administered for long periods, in the hope of much reduced risk of toxicities.      This is a national, multicentric, interventional, open-label, non-comparative, and     non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in     combination with fixed-dose of Celebrex.      This project involves 10 SFCE health centers accustomed to phase I / II studies(Société     Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French     Society for the Fight against Cancer and Leukemia in Children and Adolescents).   "
89479|NCT02115061|"     The purpose of the spring is to maintain the cyanoacrylate polymer of the gastric varix,     forming a conglomerate spring-cyanoacrylate, and thus preventing their migration to the     adhesive embolism.      The introduction of the spring is held by a echo-guided puncture. The window can be puncture     through the distal esophagus or directly in the gastric varix via retroflexion to the fundus.     Another advantage of this technique is its use in the presence of bleeding, when large     amounts of blood in the stomach hinders the injection of the cyanoacrylate, by pricking the     distal esophagus that difficulty decreases. The first study of this technique was performed     by Binmoeller et al (21) and had good results with 100% hemostasis and low rebleeding rate     (16%), but more studies are needed to prove the safety and efficacy of this technique.   "
89480|NCT02115048|"     The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole     to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.   "
89481|NCT02115035|"     The objective is to evaluate the overall response rate of Vermurafenib when administered     orally to patients with relapsed or refractory multiple myeloma.   "
89482|NCT02115022|"     Accurate staging of patients with pancreatic cancer is critical to avoid the expense,     morbidity, and mortality related to unnecessary surgery. While several tests are available     for assessing such patients, consensus has not been achieved on the optimal approach. As a     matter of fact, pancreatic cancer staging is discussed controversially due to conflicting     evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the     role of EUS and EUS-guided FNA varies among treatment centers.      The present study is designed to better define the role of EUS in predicting resectability,     as compared to high resolution cross-sectional imaging.   "
89483|NCT02115009|"     The overall goal of this study is to characterize the SIJ form, function, nerve entrapments,     lumbo-pelvic configuration and their possible relationships with nonspecific chronic LBP in     females and males. Specific aims: 1.To investigate the relationship between SIJ bridging and     NSCLBP in females and males. 2. To investigate the prevalence and characterization of nerve     entrapment of the lumbar sacral plexus around the SIJ in females and males. 3. To investigate     the correlation between the lumbar sacral plexus nerve entrapments around the SIJ and NSCLBP     in females and males. 4. To investigate the relationship between the lumbar sacral plexus     nerve entrapments around the SIJ and lumbo-pelvic morphology in females and males. 5. To     characterize the location and severity of articular degenerative changes in the SIJ and its     relationship with lumbo-pelvic morphology in females and males. 6. To investigate the     relationship between articular degenerative changes in the SIJ and LBP in females and males.   "
89484|NCT02114996|"     Vocal stimulation may encourage spontaneous breathing in patients dependent on mechanical     ventilation.      The study will include 30 patients on mechanical ventilation that will be intervened by the     vocal stimulation and 30 patients on mechanical ventilation will serve as the control group.   "
89485|NCT02114983|"     Numerous studies have demonstrated excellent diagnostic accuracy of Compression     Ultrasonography (CUS) performed by hospitals doctors, skilled and unskilled in Radiology.      Recently, it was demonstrated that adequately ultrasonography-trained General Practitioners     (GP) can perform reliable ultrasound to increase the speed and improve the quality of     clinical management of various clinical conditions. To date, in the medical literature there     are no studies that demonstrate the diagnostic accuracy of GP in performing CUS for the     diagnosis of Deep Vein Thrombosis (DVT). Therefore, we plan to perform a prospective,     multicenter, cohort study in which a large number of consecutive outpatients with symptoms or     signs of DVT are subject to the CUS by the GP with the aim of evaluating the precision and     the diagnostic accuracy compared to specialists in vascular ultrasound, which in this case     will be the standard of reference.   "
89487|NCT02114957|"     This study is to investigate how human bodies absorb and metabolize two herbal drugs. The     information is critical for drug development and could not be obtained from any other studies     using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally     exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies     indicated that AGN and decursin/DA were quite safe to animals and human.   "
89488|NCT02114944|"     Patients with severe chronic diseases are often admitted to the hospital complaining of     shortness of breath. Some of these patients decide that they do not want placement of a     breathing tube in the windpipe to assist their breathing. In this situation, these patients     are treated with oxygen, a variety of medications like morphine or masks that are connected     to breathing machines, something called bilevel positive airway pressure (BiPAP) or     noninvasive ventilation (NIV), to help with their breathing. Not much is known about how much     noninvasive ventilation helps these patients, especially how comfortable they feel with it     and how much their families think it helps.      Our aim is to monitor use of ways to help breathing in patients who don't want a breathing     tube, see how often noninvasive ventilation is used and ask surviving patients, patient's     families and caregivers about their experience with noninvasive ventilation and how much it     seemed to help.      With our findings, we hope to improve the use of noninvasive ventilation in these patients     and come up with ways to relieve their shortness of breath and provide as much comfort as     possible.   "
89489|NCT02114931|"     The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP     501 in adults with moderate to severe rheumatoid arthritis (RA).   "
89490|NCT02114918|"     Voluntary and involuntary attention processes are thought to play an important role in the     development and maintenance of anxiety disorders including OCD. Individuals with OCD pay     greater attention to threat information related to their illness and have difficulty shifting     their attention from such triggers. Studies suggest that a change in attention bias may lead     to a change in anxiety vulnerability. However, few studies have directly examined the causal     role of attention bias in the maintenance of anxiety underlying OCD and whether modification     of such biases may reduce pathological anxiety symptoms particularly in children. In this     proposal, we aim to translate basic findings from research on cognitive biases in anxiety     into a novel computerized intervention for child Obsessive Compulsive Disorder (OCD). The     treatment is designed to target a basic cognitive vulnerability in OCD, namely the selective     processing of threatening OCD-related information. 52 children with OCD will be randomly     assigned to either a 12-session attention modification program (AMP) or an attention control     condition (ACC). Clinical assessment of symptom severity along with a brief neurocognitive     battery will be conducted before and after treatment. We hypothesize that children in the AMP     group at end of treatment will show (1) decreased attention bias to OCD-related triggers     using an independent measure of attention bias to assess change and (b) reduced OCD severity.     This study is an initial step towards demonstrating the feasibility and efficacy of a novel     computerized attention training program for OCD that ultimately may prove to be a highly     transportable and accessible intervention for this childhood psychiatric disorder.     Furthermore, the project will also examine neurocognitive performance before and after     attention training to elucidate possible predictors and mechanisms of treatment response.   "
89491|NCT02114905|"     Comprehensive Behavioral Intervention for Tics (CBIT) is an evidence based intervention for     tic disorders. A recent scientific review of research priorities completed by the Tourette     Syndrome Association recommended widespread dissemination of CBIT as an important next step     in services delivery research. Given early evidence that occupational therapists can deliver     CBIT effectively, a dissemination strategy using occupational therapists may improve     accessibility to this treatment, at lower cost and with decreased stigma. Thus the goal of     this study is to develop and test a training and dissemination model with occupational     therapists (OTs) using an expert, multi-disciplinary team at Weill Cornell/New York     Presbyterian Hospital (WC/NYPH) and University of Alabama at Birmingham (UAB). The     investigators have adapted CBIT, the gold-standard behavioral intervention program for     children with tic disorders (Woods et al, 2008a,b), for eventual use in OT programs across     the country.   "
89492|NCT02114892|"     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult     population suffers the disease.      Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's     also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has     beneficial effects on glucose and lipids metabolism, blood pressure and body weight.      The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome,     insulin sensitivity and insulin secretion.      The investigators hypothesis was that the administration of resveratrol modifies the     metabolic syndrome, insulin sensitivity and insulin secretion.   "
89493|NCT02114879|"     The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an     effective treatment for older adults after disabling medical events.   "
89494|NCT02114866|"     Postoperative handovers to the post anaesthesia care unit (PACU) in adult anaesthesia are     described as incomplete and unstructured, although their relevance for the patient safety is     well known. It must be assumed that for children, this handover is at least comparable     important.      With a self-developed checklist information transfer during postoperative handovers will be     documented and subsequently compared with patient information in anaesthesia records.   "
89495|NCT02114853|"     Sepsis is common in the ICU and is associated with high mortality that reaches up to 60%,     increased duration of hospitalization and additional costs [1,2].Early diagnosis and     stratification of severity are of great importance in order to timely apply proper and     adequate treatment [3].      Oxidative stress is implicated in inflammation and sepsis and sepsis severity seems to     correlate with increased oxidative stress [7,8]. Monitoring of oxidative stress has been done     so far with various markers which reflect the different pathways of oxidative stress as is     oxidosis of lipids, proteins, nucleic acids; yet the antioxidant capacity of various enzymes     and vitamins has been studied [9]. However these methods do not reflect oxidative stress as a     whole, are time consuming, need special laboratory procedures and are costly.      Oxidation-reduction potential is a new technique that enables bedside assessment of the     oxidative status. It is based on measuring the balance of oxidants and reductants in human     blood with a simple plasma test that reports results immediately.      Hypothesis      Oxidation-reduction potential, used for oxidative monitoring in ICU patients, might correlate     with sepsis severity and may be used in addition to other clinical and/or inflammatory     markers to assess severity and possibly prognosis.   "
89496|NCT02114840|"     The purpose of this study is to determine pronator quadrutus preservation have clinical     impact following volar plate fixation   "
91032|NCT02094547|"     To compare the neurocognitive and immunological development in infants fed a new infant     formula with functional specific nutrients to infants consuming a standard infant formula.   "
89498|NCT02114814|"     The aim of this study is to compare the efficacy of an intervention and an attention control     group in producing changes in diabetes self-management, A1C and health related quality of     life in Hispanics with type 2 diabetes.      Hypothesis: The experimental group who receive an 8 week intervention program will show     significantly greater improvements than an attention control group at 1 and 6 months after     the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and     family support, outcomes of self-reported management of diabetes (physical activity, diet,     medications, and glucose monitoring), A1C levels, and psychological outcomes of     health-related quality of life.   "
89499|NCT02114801|"     The aim of the present study was to determine the effectiveness of brushing with an electric     toothbrush switched on and switched off in comparison to manual brushing for the removal of     dental plaque in children aged four to 16 years with cerebral palsy.   "
89566|NCT02113748|"     This randomized control trial will investigate whether a modality that generates more     contractile muscle fatigue with lower ventilatory requirements render better results after a     12-week exercise training program in subjects with COPD.      Subjects will be randomized to either exercise in a training program including downhill     walking or to exercise in a training program including conventional walking.   "
89567|NCT02113735|"     This study is being performed to evaluate the potential efficacy and safety of Acthar as a     treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210     subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study     medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a     blinded gradually tapering regimen, and subjects will be followed for 60 days     post-randomization.   "
89500|NCT02114788|"     The aim of the study is to study how to improve patients' management of chronic back pain,     particularly their management of prescription medication, through increasing health literacy     and patient empowerment through an internet based intervention. We do this by designing both     patient education materials and physician communication strategies to increase literacy and     volitional components of patients. We will test two conditions using a website called     Oneself: one providing only information (literacy-only control) and a second providing     relational communications designed to increase both literacy and volitional empowerment. To     test the self-management enhancing effects of empowerment and health literacy, we will     conduct a longitudinal experiment with 51 chronich back pain patients over two months. This     span of time is the minimum necessary to achieve a systematic change in self-management and     literacy skills, increasing also the range of possible decisions to be made and actions to be     real-ized by the patients.   "
89501|NCT02114775|"     The overall goal is to determine whether perceptual or performance fatigue can be reduced in     MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover     fashion based upon GH status.      A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed     to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.   "
89502|NCT02114762|"     This study evaluates the usefulness and safety of using a balloon to dilate (make larger) the     Eustachian tube in adults who have middle-ear disease due to Eustachian tube dysfunction.   "
89503|NCT02114749|"     This study is aimed to develop analysis methods and measurements tools for physiological     variables : respiration, circulation and their mutual interactions and with the functions     involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...).     The devices that are used are non invasive. The development of these tools needs to be     validated on physiological signals obtained in healthy volunteers.   "
89504|NCT02114736|"     Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee     gait is a frequent condition among stroke patients leading to reduce gait speed and increase     energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the     rectus femoris is recommended. However, the botulinum toxin A effect is transient     necessitating repeated injections.      The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison     with botulinum toxin A injections according to the 3 domains of the International     Classification of Functioning Disability and Health of the World Health Organisation   "
89505|NCT02114723|"     Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms     most frequently described in primary dysmenorrhea.   "
89506|NCT02114710|"     The purpose of this study is to find out whether stress doses of hydrocortisone attenuate     coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by     which little doses of hydrocortisone influence coagulation system in sepsis.   "
89507|NCT02114697|"     The goal of this study is to assess a slimy substance that settles/deposits along blood     vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium     or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various     parts of body. Blood vessels include vessels that supply to heart (coronary), vessels to     brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral). Decreased blood     flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly individuals at     risk of cardiovascular disease can have certain markers elevated in their blood that can be     measured by simple blood tests.      High or increased plaque deposition is seen in neck vessels of cancer patients who received     radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are     at increased risk of plaque development and are therefore called high-risk population.     Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins are     one of the several fat lowering medications.   "
89508|NCT02114684|"     This is an open label randomized controlled clinical trial comparing two regimens for     treatment of smear-positive pulmonary TB, among patients previously treated for TB. The     primary objective is to determine if a moxifloxacin-containing regimen, substituting     moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24     weeks duration in improving treatment outcomes in patients with recurrent TB and shortens the     duration of TB treatment.   "
89509|NCT02114671|"     To investigate the potential of Faldaprevir to induce skin phototoxicity, immediate or     delayed type, to UV light and visible light in healthy male and female subjects. To     investigate the degree, wavelength dependency, severity, pigmentation and morphology of the     phototoxic effects. The persistence of the phototoxic susceptibility will be explored     following cessation of study medication. Within a sunscreen sub-study, the efficacy of     commercially available high factor sunscreen will also be assessed in terms of its potential     to prevent any phototoxic skin responses seen. The safety and tolerability of Faldaprevir     will also be assessed.   "
89510|NCT02114658|"     The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of     sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or     locally advanced or metastatic medullary thyroid carcinoma (MTC).   "
89511|NCT02114645|"     This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered     in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and     GnRH antagonist protocol.   "
89513|NCT02114619|"     Radioactive iodine (RAI) administration is an effective and completely established treatment     modality in hyperthyroidism including Graves' disease. Despite the long experience with     radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine     that is required to achieve long-term euthyroidism. The fixed activity administration method     does not optimize the therapy, giving often too high or too low radiation to the gland, but     the optimal dose per gram of thyroid mass in calculated activity administration method is     also under much debates. This prospective study has been designed in order to compare the     effect of different calculated doses of radioiodine on Graves' disease treatment outcome.   "
89568|NCT02113722|"     The purpose of this study is to determine whether the incidence of recurrent life threatening     ventricular arrhythmias in patients with an implanted cardiac defibrillator (ICD) can be     reduced if a surgical left stellate ganglionectomy is performed.   "
89514|NCT02114606|"     The current endoscopic methods for diagnosing and monitoring treatment response in     Eosinophilic Esophagitis (EoE) are costly, inconvenient, and risky. Novel diagnostic methods     are needed, and the minimally-invasive Cytosponge holds great promise. It has been shown to     be safe and accurate in Barrett's esophagus, it has the advantage (over the string test) of     obtaining a true tissue sample, and our preliminary data supports its further study in EoE.     The proposed prospective cohort study, conducted by experts in esophageal diseases and EoE,     will assess the accuracy of Cytosponge compared to endoscopy and biopsy in EoE, and determine     the safety and acceptability of this technique. Use of the Cytosponge would fundamentally     change the paradigm for clinical management of EoE by allowing collection of non-endoscopic     esophageal biopsies, thus minimizing the need for invasive testing. It would also facilitate     future genetic, mechanistic, and pathogenesis research in EoE.   "
89515|NCT02114593|"     The aim of this project is to evaluate the effectiveness of a culturally adapted parenting     support program for Somali parents living in Sweden on children's and parent´s mental health.     In recent years the Somali population in Sweden has increased and is currently one of the     largest groups among ethnic minorities. Most of the Somali people have arrived as refugees     and have experienced war, trauma and conflict. Research shows that migration to a new social     context/society is challenging for a family and may together with previous experiences of     war, separation, create stress and mental illness. This leads to consequences such as family     violence, child abuse, relational problems, drug problems and school problems for children.     There is a vast knowledge on the association between parents' mental health, positive     parent-child relationship and children's health and well-being. Previous studies have shown     that parenting programs aimed to support parent-child relationship and/or improve parental     skills have positive effects on parental mental health and on children's behavior. Most     municipalities in Sweden offer their residents a structured parenting program, but these     programs do not reach those of ethnic minorities. Studies show that parenting programs mainly     target parents who can speak Swedish fluently and that the parenting programs are not yet     culturally adapted.   "
89516|NCT02114580|"     The proposed study aims to explore brain mechanisms mediating the cognitive benefits of     aerobic exercise in patients with mild cognitive impairment- a prodromal stage of Alzheimer     disease. We will perform FMRI experiments, as well as laboratory and behavioral tests that     will advance our knowledge about the nature of these mechanisms. Participants will     participate in individual- tailored aerobic training program. Pre and post evaluation will     identify brain changes following the training using advanced techniques of brain imaging.     Cognitive performance will be assessed prior and at the end of the program, as well as     endocrine markers reflecting improvement in learning abilities. Moreover, demonstrating     cortical plasticity in subjects with aMCI has tremendous practical significance for these     subjects .   "
89517|NCT02114567|"     Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive     end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of     breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level     compared with pressure-support ventilation (PSV)   "
89518|NCT02114554|"     Mitochondrial diseases are multisystem disorders that present with a wide range of clinical     manifestations. Mitochondrial DNA nt3243A>G mutation is one of the most common mutations seen     in mitochondrial diseases. Syndromes associated with this mutation include mitochondrial     encephalopathy, lactic acidosis, and stroke-like episodes (MELAS), maternally inherited     diabetes and deafness (MIDD), myoclonic epilepsy with ragged red fibers (MERRF), and chronic     progressive external ophthalmoplegia (CPEO). Clinical analyses of mitochondrial DNA nt3243A>G     mutation from Taiwan remain scarce. The present study aims to investigate the clinical     features and prognostic factors of patients with mt3243A>G mutation in Taiwan.   "
89519|NCT02114541|"     The relationship of the natural history of atherosclerosis between different vascular beds     has not been well characterized. Determination and comparison of the relative rates of     progression and extents of atherosclerosis in the coronary and carotid arterial trees may     have major impacts on clinical research and clinical practice. Correlation between findings     in the carotid and coronary circulations is an important scientific and clinical topic to     address. Results from a well design study incorporating imaging technologies that currently     represent the gold standards for the assessment of coronary and carotid artery plaque burden,     will have potentially impact on clinical research and clinical practice.   "
89520|NCT02114528|"     The purpose of this study is to determine whether catheter based ablation is better than     conventional anti-arrhythmic drug (AAD) therapy for reducing recurrent shocks in patients     with an implantable cardioverter defibrillator (ICD). The second purpose of the study is to     determine the safety of catheter-based ablation and the effect on quality of life of     patients.      The study hypothesis is that catheter ablation is superior to AAD therapy in preventing     recurrent ventricular arrhythmia in such subjects. This is a pilot trial which will provide     data regarding recruitment potential and the feasibility of conducting a larger trial.   "
89521|NCT02114515|"     Staying out of the hospital is valued by patients and their caregivers. Their interests     converge with those of hospitals now that high 30-day readmission rates for some conditions     place hospitals at risk for financial penalties from the Centers for Medicare and Medicaid     Services. This study focuses on developing and testing a program that combines a community     health worker (lay patient advocate, acting as a Patient Navigator) and a peer-led     telephone support line to improve patient experience during hospital to home transition.   "
89522|NCT02114502|"     The goal of this clinical research study is to learn if carfilzomib and vorinostat combined     with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control     multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of     this combination.   "
89581|NCT02113553|"     This is a multicentre, prospective study willing to evaluate AMH levels changes in response     to chemotherapy plus GnRHa.      In the present study we propose to determine AMH levels in breast cancer patients, aged     <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim     to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted     by GnRHa.   "
89582|NCT02113540|"     As the effect of statin use before the angiography to prevent contrast induced nephropathy     (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin     on prevention of CIN in patients undergoing coronary angiography.   "
89523|NCT02114489|"     Aseptic osteonecrosis of the hip (AOH) concern 1 Swiss young adult to 1000 (30-40 years old).     They are responsible to a severe joint destruction and in the majority of cases a joint     replacement. To the hip, we can distinguish 4 stages of osteonecrosis according to Ficat: 1,     2, 3, 4. Stage 3 and 4 AOH management are unanimous surgical. But management of stage 1 and 2     are unclear. Bisphophonates are mainly used for bone and osteoporosis diseases. They decrease     the bone turn over, and the risk of fracture. They also decrease the bone marrow oedema and     the pain associated to this oedema. Ibandronate is a bisphosphonate with a rapid effect, a     short half-life, easy to manage, and with few side effects. We designed a double-blind     prospective randomized trial aiming to evaluate the efficacy of an infusion of ibandronate     versus placebo on pain and AOH progression in patients with stage 1 and 2 AOH. Our hypothesis     is that there will be a pain reduction >=20 mm on the VAS scale (SD 10mm) in the ibandronate     group versus placebo, and a non radiological progression in the treated group.   "
89524|NCT02114294|"     This is a Randomized Controlled Trial (RCT) regarding conservative treatment of     Patellofemoral Pain Syndrome (PFPS). Patellofemoral Pain Syndrome (PFPS) is a very common     cause of knee pain in young active adults with a high rate of recurrent and/or chronic     occurrence. PFPS is notoriously difficult to treat and has been referred to as one of the     most vexatious clinical challenges in rehabilitative medicine. Its etiology is unclear but     is commonly thought to be related to pathomechanics in the patellofemoral joint (PFJ). There     are many factors that can influence PFJ mechanics. Among these, quadriceps strength and     timing has been shown to be important. As such, treatment of PFPS has traditionally been     based on correction of pathomechanics through influencing quadriceps strength and timing.     However, a growing body of evidence is revealing the importance of strength and control of     hip abduction and external rotation in PFPS. Hip strength in ab/adduction and rotation is     thought to influence femoral positioning in the patellofemoral joint, thereby affecting PFJ     mechanics. Several cohort and smaller RCT studies within the last 7 years have shown that     additional exercises for hip strength and control give an improved effect in pain and     function compared with quadriceps based training alone. A smaller RCT from 2012 compared     isolated hip strengthening exercises to a control group and found surprisingly good results     on pain in function in the hip strengthening group. The investigators plan a RCT in which     isolated hip strengthening will be compared to traditional quadriceps training and a control     group which will receive no structured training. Primary outcomes will be pain and function.     This high-quality study will include 40-50 patients in each group, making it one of the     largest of its kind on conservative treatment for PFPS. In contrast to the vast majority of     studies of this type, this study will also include men, which will potentially help to fill a     significant gap in the literature on this subject. The investigators study will therefore be     an important contribution to elucidating the etiology of PFPS and improving treatment options     for both men and women in the future. As well, the role of psychometric parameters will be     examined and a standardized clinical test for hip abduction endurance will be developed.   "
89525|NCT02114281|"     A large panel of oral and dental diseases exist in patients suffering from chronic kidney     disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and     saliva and it has been already described in the literature. The consequences of oral diseases     in systemic health are substantial, including increase of inflammatory parameters, alteration     of nutrition and increase of cardiovascular risk factors. It has been shown before that     several oral diseases can be considered as cardiovascular risk factor in the general     population and in diabetic patients through the chronic inflammatory pathway. In CKD     patients, the influence of oral diseases on the progression of the chronic kidney disease is     not yet established, as most of the studies are focused on stage 5 CKD or dialysis patients.     That's why the interactions between dental health and CKD will be evaluated in this     population of patients, at different stages of the disease (stages 2 to 5).      The main objective will be to describe the oral diseases at each stage of CKD. Secondary     objectives will be: (1) To evaluate the link between the oral health and the chronic kidney     disease stage, the nutritional and inflammatory status; (2) Among patients needing dental     treatments, to evaluate after 6 months and 12 months whether dental cares have an influence     on nutrition parameters, inflammatory status and CKD; (3) to evaluate the completion of     dental treatments after the dental consultation including advises on dental health.   "
89526|NCT02114268|"     The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an     extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to     placebo when administered to healthy adult participants.   "
89527|NCT02114255|"     In the present study, the investigators want to investigate whether prior BCG-vaccination     improves the efficacy of influenza (the flu) vaccination in young and/or old healthy     volunteers and consequently could protect against influenza virus infection.   "
89528|NCT02114242|"     Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy     (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are     characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates     in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and     PSP remains an unmet need. Such biological markers are crucial for future     disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for     biomarker development since it constitutes the pathological hallmark feature in PD and MSA.     The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein     aggregation in alpha-synucleinopathies.      The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and     PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling     at two study visits (baseline and after 12 months). Major secondary objectives are (i) to     assess potential associations between the biomarker and clinical measures of disease severity     and progression in MSA and PSP, and (ii) to assess the variation of the biomarker and its     correlation to disease severity and progression in PD, MSA and PSP.   "
89555|NCT02113891|"     Advances in renal transplantation have increased life-expectancy in patients with end-stage     kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft     losses due to T-cell mediated rejection. However, emerging data suggest that the majority of     late kidney failures may be attributable to antibody-mediated rejection (AMR), which poorly     responds to the currently available therapeutics. Complement-fixing donor-specific anti-HLA     antibodies are associated with the worst outcome in keeping with the well-established role of     the complement in AMR pathogenesis. Eculizumab, the first licenced complement blocker, has     been found efficient in reducing the occurrence of AMR lesions in highly sensitized patients.     A few reports also suggest that complement blockade may be of great value as salvage therapy     for graft-threatening severe AMR. However, no information is available in the literature     about the interest of complement blockade in curbing the progression of subclinical acute AMR     to chronic AMR.      The purpose of this study is to determine whether complement blockade with eculizumab is     effective and safe in the treatment of subclinical AMR in sensitized kidney transplant     recipients.      Despite appropriate therapies, up to 75% of patients having received a renal transplant with     preformed donor-specific antibody display subclinical AMR on their 3-month protocol biopsy.     Subclinical AMR is defined by histological lesions of AMR concomitant with stable graft     function. Moreover, the extent of these lesions at 3 month post-transplant correlates with     the occurrence of irreversible scars and chonic antibody-mediated rejection on the 12-month     biopsy.      This study aims to explore the efficacy and safety of eculizumab in patients exhibiting     subclinical AMR on their 3 month-post-transplant biopsy, to reduce or even normalize     microcirculation inflammation, and to prevent chronic rejection (transplant glomerulopathy)     on the 12 month-screening biopsy. Eculizumab-treated patients will be compared with     historical controls, matched for the lesions on the 3 month biopsy.   "
89529|NCT02114229|"     This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in the     treatment of patients younger than 22 years of age. Patients with recurrent or refractory     AT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RT     will receive alisertib as part of age- and risk-adapted chemotherapy. Radiation therapy will     be given to children ≥12 months of age. Patients with AT/RT and concurrent extra-CNS MRT are     eligible.      Alisertib will be administered as a single agent on days 1-7 of each 21-day cycle in all     recurrent patients enrolled on Stratum A. For the patients on the newly diagnosed strata (B,     C or D), alisertib will be administered in sequence with chemotherapy and radiotherapy.      This study has 3 primary strata: (A) children with recurrent/progressive AT/RT or extra-CNS     MRT, (B) children < 36 months-old with newly diagnosed AT/RT, (C) children > 36 months old     with newly diagnosed AT/RT. Children with concurrent MRT will be treated according to age and     risk stratification schemes outlined for strata B and C and will have additional treatment     for local control. Children with synchronous AT/RT will be treated with age and CNS     risk-appropriate therapy, and also receive surgery and/or radiation therapy for local control     of the non-CNS tumor.      PRIMARY OBJECTIVES        -  To estimate the sustained objective response rate and disease stabilization in pediatric          patients with recurrent or progressive AT/RT (atypical teratoid rhabdoid tumor in the          CNS) (Stratum A1) treated with alisertib and to determine if the response is sufficient          to merit continued investigation of alisertib in this population.        -  To estimate the sustained objective response rate and disease stabilization in pediatric          patients with recurrent or progressive extra-CNS MRT (malignant rhabdoid tumor outside          the CNS) (Stratum A2) treated with alisertib and to determine if the response is          sufficient to merit continued investigation of alisertib in this population.        -  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are younger          than 36 months of age at diagnosis with no metastatic disease (Stratum B1) treated with          alisertib in sequence with induction and consolidation chemotherapy and radiation          therapy (depending on age) and to determine if the rates are sufficient to merit          continued investigation of alisertib in this population.        -  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are younger          than 36 months of age at diagnosis, with metastatic disease (Stratum B2) treated with          alisertib in sequence with induction and consolidation chemotherapy and to determine if          the rates are sufficient to merit continued investigation of alisertib in this          population.        -  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are 3 years          of age or greater at diagnosis with no metastatic disease and gross total resection or          near total resection (Stratum C1) treated with alisertib in sequence with radiation          therapy and consolidation chemotherapy and to determine if the rates are sufficient to          merit continued investigation of alisertib in this population.        -  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are 3 years          of age or greater at diagnosis with metastatic or residual disease (Stratum C2) treated          with alisertib in sequence with radiation therapy and consolidation chemotherapy and to          determine if the rates are sufficient to merit continued investigation of alisertib in          this population.        -  To characterize the pharmacokinetics and pharmacodynamics of alisertib in pediatric          patients and to relate drug disposition to toxicity.      SECONDARY OBJECTIVES        -  To estimate the duration of objective response and PFS in patients with          recurrent/progressive AT/RT and MRT (Strata A1 and A2).        -  To estimate PFS and OS distributions in patients with newly diagnosed AT/RT (Strata B1,          B2, B3, C1 and C2).        -  To describe toxicities experienced by patients treated on this trial, specifically any          toxicities of alisertib when administered as a single agent or in combination with other          therapy over multiple courses and toxicities related to proton or photon radiation          therapy.        -  To describe the patterns of local and distant failure in newly diagnosed patients          (Strata B1, B2, B3, C1 and C2). Local control relative to primary-site radiation          therapy, with criteria for infield, marginal, or distant failure will also be reported          descriptively.   "
89530|NCT02114216|"     Transient receptor potential vanilloid-1 (TRPV1) receptor and proteinase-activated receptor 2     (PAR2) have been implicated in the mechanism of acid induced inflammation in gastroesophageal     reflux disease (GERD). We aimed to evaluate TRPV1 and PAR2 mRNA expression levels in the GERD     patients and their relationship with endoscopic findings and reflux symptoms.   "
89531|NCT02114203|"     This study is being conducted to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell     disease with and without co-administration with hydroxyurea. This study will also aid in     selecting the doses for future studies and evaluation of substances in the blood which may     help access the effectiveness of the drug.   "
89532|NCT02114190|"     With currently 35% of U.S. adolescents being overweight and one in six having metabolic     syndrome, adolescent obesity is one of the major global health challenges of the 21st     century. Few enduring treatment strategies have been identified in adolescent populations and     the majority of standard weight loss programs fail to adequately address the impact of     psychological factors on eating behavior and the beneficial contribution of parental     involvement in adolescent behavior change. A critical need exists to expand treatment     development efforts beyond traditional education and cognitive-behavioral programs and to     explore alternative treatment models for adolescent obesity. Meditation-based mindful eating     programs may represent a unique and novel scientific approach to the current adolescent     obesity epidemic as they address key psychological variables affecting weight. Furthermore,     the recent expansion of mindfulness programs to include family relationships shows the     immense potential for broadening the customarily individual focus of this intervention to     include broader factors thought to influence adolescent health outcomes. Thus, we propose to     develop a mindful eating approach to eating behavior and weight loss specifically tailored     for adolescents and their families. The first phase of our three phase development process     will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an established     mindful eating program currently being used with adult populations. We will then develop a     'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a family     systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful     Eating-A to include family factors that influence adolescent eating behaviors. The second     design phase will consist of an initial test of both intervention components to provide     feedback on usefulness and acceptability (N = 10 families). The final phase will examine the     overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A     intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least     one parent. Within this examination, post-treatment and 3-month follow-up comparisons across     the two treatment approaches will be made and effect sizes within and between treatments will     be assessed.   "
89533|NCT02114177|"     The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12     weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus     (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or     treatment-experienced.   "
89534|NCT02114164|"     The AirSeal® System will allow for lower CO2 absorption rates than the Xcel® System.     Furthermore, lower variance in pneumoperitoneal pressure will allow for less over-pressure     events and peritoneal stretch, which may reduce postoperative pain.   "
89535|NCT02114151|"     The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir     (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV)     genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or     treatment-experienced.   "
89536|NCT02114138|"     The risk for postoperative acute kidney injury (pAKI), as for any other postoperative     complications (PC), comes from a number of interactions between a patient's health before     surgery, strength to tolerate surgery and influences on the operating room environment. At     this time doctors do not have good tools to predict which patients may be at risk of having     this complication. The purpose of this research study is to develop a urine test that can be     used to predict the risk for having problems with kidney function after major surgery.   "
89537|NCT02114125|"     Investigators assume that there are some positive effects of cognitive training and physical     activities on cognitive function, depression and quality of life in a sample of older     residents in long-term care facilities.      The purpose of this study is to explore the effects of various interventions (physical     activity, cognitive training, integration of physical activity and cognitive training) on     different outcome indictors in institutionalized older residents.   "
89538|NCT02114112|"     Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP)     cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks gestation     to nasal prongs.      Methods: A total of 40 infants with a gestational age (GA) of 25-28 weeks ventilated for     respiratory distress syndrome (RDS) and extubated to NCPAP are eligible for the study. They     will be randomized to NCPAP cycling {Group A; cycling between NCPAP of 4 cm and 1litre per     minute of nasal prongs} or to continuous CPAP at 4 cm of water (Group B). Primary outcome is     the number of babies who came off NCPAP at the end of 72 hours of the intervention and     remained off NCPAP for the next 72 hours. The duration of NCPAP, Bronchopulmonary dysplasia     (BPD) at 36 weeks post menstrual age and Retinopathy of Prematurity (ROP) stage ≥3 will be     the secondary outcomes.   "
89556|NCT02113878|"     This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment     for locally advanced head and neck squamous cell cancer.   "
89539|NCT02114099|"     Background Kawasaki disease (KD) is characterized by fever, bilateral nonexudative     conjunctivitis, erythema of the lips and oral mucosa, changes in the extremities, rash, and     cervical lymphadenopathy. Incidence of late coronary artery aneurysms or ectasia, which may     lead to myocardial infarction (MI), sudden death, or ischemic heart disease, decreased after     the introduction of intravenous immunoglobulin therapy. However, significant persistent     coronary arterial lesions or aneurysms may still occur in about 1-3 % of the patients.      Atorvastatin (Lipitor®), a kind of statin, is a selective competitive inhibitor of     3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This drug had been safely and     widely used for treatment of adult hyperlipidemia, prevention of coronary heart disease and     familial hypercholesterolemia in childhood. In addition to the cholesterol-lowering effects,     statins exerts diverse cellular, cholesterol-independent effects, including improvement in     endothelial function, inhibition of neurohormonal activation, and reduction in levels of     proinflammatory cytokines. Based on the above concepts, some patients with infrarenal     abdominal aortic aneurysms received statin therapies and then the growth rate of aneurysms     slowed down.      Therefore, the investigators may hypothesize that Atorvastatin is helpful in the regression     of persistent coronary lesions in KD patients due to its effect of anti-inflammation. In     NTUH, there are about 20 KD patients with coronary lesions persistent for many years. And the     investigators plan to conduct the clinical trial with atorvastatin to evaluate the effects of     Atorvastatin on the persistent coronary arterial lesions/aneurysms in children with Kawasaki     disease including safety and efficacy.      Methods      There are around 20 KD patients eligible for this study. After they sign the IRB-approved     ICF, they will be enrolled for this study. Briefly, this study is divided into three stages:     screening & enrollment stage (I), treatment & follow-up stage (II) for 1 year and final data     analysis stage (III). Measurements include basic vital sign, electrocardiography, liver     function, muscle enzyme, inflammatory markers and echocardiography.      Predicted results      1.Oral atorvastatin therapy can effectively prevent the progression of coronary lesions in KD     patients.   "
89540|NCT02114086|"     In this study the investigators observe the investigation, whether the new method for     Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence,     acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.   "
89541|NCT02114073|"     Glaucoma is one of the leading causes of blindness worldwide and trabeculectomy is the most     commonly performed operation to slow-down the disease progression. In this study, we compare     the effect of topical cyclosporine A and betamethasone eye drops on the postoperative course     and surgical success of trabeculectomy.   "
89542|NCT02114060|"     This is a randomized, double-blind, factorial study to compare the reduction in viral     shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2     adjuvant.      Secondary objectives of the study include:        -  Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2          compared to placebo.        -  Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among          the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:             -  Time to first clinical and/or virologic recurrence,             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last               dose of vaccine,             -  Lesion rate (percent of days with genital lesions present) during the               post-vaccination swabbing periods.        -  Evaluation of cellular and humoral responses to GEN-003 antigens.      Additional objectives include:        -  Assessment of the correlation between immune responses and change in viral shedding or          impact on clinical disease as defined above.        -  Determination of the recurrence rate in a subset of subjects not receiving suppressive          antivirals throughout the study.      Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive     days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals.     Subjects will be followed for safety and immunologic response for 12 months following their     last dose.   "
89543|NCT02114047|"     This study with evaluate blood flow in the lungs of patients prior to and after surgery for     treatment.   "
89544|NCT02114034|"     The purpose of this prospective study is:        -  to identify by cluster analysis the main phenotypes of severe asthma and factors          involved in the severity,        -  to determine the clinical and functional outcomes,        -  to identify the factors associated with severe asthma from childhood to adulthood.   "
89545|NCT02114021|"     ABSTRACT:      The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly     (over tracheal tube cuff) compared with distilled water on the post intubation syndrome     incidence. This study has not been carried out in Iran.      99 patients of either sex undergoing elective surgery were recruited in a single blind     randomized study. The patients, using randomization table, were divided into three groups.     Anesthetics and medications used during surgery were similar for all the patients.      For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the     voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of     medications were obtained.   "
89546|NCT02114008|"     To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have     traditionally been minimized with overnight fasting. However, prolonged fasting can also have     some adverse consequences and has been abandoned for some procedures in several patient     populations with the exception of obese and/or diabetic patients. The aim of this study was     to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.   "
89547|NCT02113995|"     Background To evaluate clinical results, insulin resistance and inflammatory response to     trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received     either traditional preoperative care or treatment following the ACERTO protocol.   "
89548|NCT02113982|"     This is a 4-stage, non-randomized, open-label, dose escalation and expansion, multicenter     study. A cycle of therapy is 21 days. Stage 1 was a dose-escalation stage. During Stages 2-4,     patients are treated at the MTD or maximum tested dose at which multiple DLTs are not     observed during Stage 1.   "
89557|NCT02113865|"     The aim of this study is to establish a clinical score panel based on clinical, molecular and     genetic parameters that allow us to stratify and obtain an early detection of patients with     an increased risk of developing hepatocellular carcinoma (HCC).   "
89558|NCT02113852|"     This is an epidemiological,multicenter study of genomic and expression profiles of patients     with newly diagnosed NSCLC.Two hundred and fifty NSCLC patients who fulfill the criteria are     to be recruited by investigational sites.Approximately 100 of them will be from     retrospectively collected samples with detailed clinical and 2-year follow-up information     after surgeries.The demographics,cancer/adjacent normal tissue and matched blood sample will     be collected after the patient had provided informed consent.All tissue samples will be     analyzed for somatic mutations by exome deep sequencing,mRNA expression profiling by RNA     sequencing and chromosome copy number variation by SNP array at the designated laboratories.   "
89549|NCT02113969|"     Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment can     be surgical or conservative using vaginal pessaries. These devices are introduced into the     vagina aiming to reduces the prolapse.      Pessaries have shown effectiveness in improving symptoms and quality of life. There are no     randomized studies comparing them with surgery. This study design would be difficult to     perform, because the inclusion criteria for both treatments are different. There are no     currently standard protocols for the use of pessaries. This makes harder to widespread the     usage of this conservative treatment.      The aim of the investigators is to identify variables that influence the success of     conservative management of genital prolapse at 1 year of follow up. Using these variables and     an expert panel opinion the investigators will develop a standardized protocol for pessary     management.      Chile has a primary gynecological care system based midwives. Therefore having algorithms for     pessaries usage becomes relevant. This algorithm can be implemented with basic training. This     would increase the respond capacity, by the health care system to this disease, considering     the scarce access to surgery.      The investigators hypothesis is: It is possible to generate a standardized protocol of     conservative management of symptomatic genital prolapse in patient's beneficiary of public     health system in Santiago, Chile, using pessaries through a prospective cohort study based in     the success of these devices with 1 year of follow up, measured with questionnaires of     symptoms, quality of life and sexuality   "
89550|NCT02113956|"     The purpose of this study is to examine whether Guy2Guy (G2G), a text messaging-based healthy     sexuality and human immunodeficiency virus (HIV) prevention program intervention for 14-18     year gay, bisexual and queer men, is associated with HIV preventive behavior (e.g., condom     use) compared to an attention-matched control group.   "
89551|NCT02113943|"     The aim of the current study is to examine the role of serotonin on the cognitive parameters     of motivation. They are embedded in a conceptual framework of motivation that merges     decision-making and reinforcement learning theories. Every action is conceived as path from     one state to another. The different states are associated to different values (positive for     rewards and negative for punishments), and the different actions to different costs (risk,     effort and delay). The tasks are designed such that the sensitivity to the state and action     parameters can be inferred by fitting computational models.The primary objective is to     characterize the effect of Citalopram 30mg on reward sensitivity, assessed in an incentive     force task, in which participants are asked to squeeze a hand grip to win monetary rewards.     Secondary objectives are to characterize the effect of Citalopram 30mg on other cognitive     parameters of motivation (assessed with a motivational battery that includes rating, choice     and learning tasks).   "
89552|NCT02113930|"     Definition: Idiopathic CD4+ T lymphocytopenia (ICL) is an immune deficiency first described     in 1992 and characterized by the US Centers for Disease Control (CDC) as absolute CD4+     T-lymphocyte count < 300/mm3 or < 20% of total T cells on more than one cell count; no     evidence of infection with HIV-1/2 or human T-cell lymphotropic 1/2 (HTLV-1/2); and lack of a     defined immune-deficiency disease or therapy for lymphocytopenia. Epidemiologic, clinical and     immunological characteristics of the syndrome were described in 1993 and ICL is now     considered a heterogeneous syndrome not caused by an infectious agent. Patients with ICL may     show opportunistic infections such as disseminated Cryptococcus neoformans infection,     Pneumocystis jiroveci pneumonia and John Cunningham (JC) virus infection as a result of     profound cell-mediated immune-response deficiency.      Few studies have focused on the pathophysiology of ICL. CD4+ T-lymphocyte phenotyping     revealed increased CD95 expression that could be responsible for excess apoptosis leading to     lymphocytopenia. Moreover, the membrane expression of C-X-C chemokine receptor type 4 (CXCR4)     was found impaired in T lymphocytes with ICL, and CXCR4 trafficking was improved with     interleukin 2 (IL-2) treatment in some patients. Recently, mutations in nunc119, MAGT1 and     Rag were found associated with CD4+ T lymphocytopenia. In a prospective study of 39 patients,     CD8+ T lymphocytopenia (<180/mm3) and degree of CD4+ T-cell activation measured by human     leukocyte antigen DR (HLA-DR) expression was found associated with poor prognosis.      ICL is a heterogeneous disorder often associated with deficiencies in CD8+, CD19+, and/or NK     cells. Long-term prognosis may be related to initial CD4+ and NK cell deficiency.      Larger studies are needed to better identify the patients who might benefit from IL-2     therapy. This is why the investigators conduct the Lympho-4 study, in which the investigators     plan to include 200 patients with a suspected/proven diagnosis of ICL.   "
89553|NCT02113917|"     Different study of HLHa patients :        -  Diagnosis criteria, because criteria are based on pediatric genetic studies.        -  Physiopathological studies: genetic studies have demonstrated the role of CD8+ cells, in          particular because they have a genetic defect affecting their cytotoxic functions in HLH          pediatric. the aim is to establish if the same defect is found in both some or in all of          HLHa patients. If this is the case, to then establish whether hypomorphic genetic          mutations are responsible.   "
89554|NCT02113904|"     The main objective of this studies therapeutic : to determine the effect of Adalimumab     (HumiraR) on clinical inflammatory manifestations of patients with Netherton syndrome after 3     months of treatment , with a post treatment period follow-up of 3 months.      Second objectives are To evaluate the safety of Adalimumab in the context of NS To evaluate     the improvement of the quality of life at 3 months To evaluate the improvement of pruritus     and pain in the patients To study markers of inflammatory and allergy in NS prior and after     treatment Benefit of the study An improvement by at least 20% of the cutaneous signs in these     patients who suffer from a genetic incurable, chronic, painful and very afflicting disease     would be of a great help for these patients. NS is a major source of social exclusion.      Risks They are inherent to the risks of biotherapies, especially for an anti-TNF therapy,     they comprise a risk of infection. Cutaneous infections occur mainly during infancy, and we     have therefore chosen to treat patients over 4 years of age in this study.      A close clinical surveillance will be set up (initially every week during the first month of     treatment, then every month). This will represents a large number of visits but will provide     a high level of security.      Benefits/risks ratio In the absence of curative treatment for these patients with a severe     genetic skin disease, the benefits/risks ration clearly appears to be in favour of an     expected benefit.   "
89559|NCT02113839|"     The perception of breathlessness varies significantly among COPD patients with similar     severity of airflow limitation; those with poorer perception report less exacerbations as     compared to those with frequent exacerbations.      Cross-sectional comparison of breathlessness perception in COPD patients with frequent     exacerbations or without frequent exacerbations.      To assess Breathlessness Perception the investigators will increase the ventilatory demand     of the patients by CO2-rebreathing method.   "
91389|NCT02089880|"     The study will specifically evaluate the potential of the C-Brace to improve the functional     mobility and quality of life in individuals with lower extremity impairments due to     neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance     control orthosis.   "
89569|NCT02113709|"     Objective: To find out how much visual improvement is possible in severe amblyopia using     full-time occlusion therapy with an eye patch and to see if improvement is influenced by the     patient's age.      Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe     amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients     were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36).     After a complete ophthalmological examination by a single ophthalmologist, cases with organic     visual loss were excluded; cases with previous part-time occlusion therapy that had failed     were included in the study. Patients were given optimal refractive correction for a month,     followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day.     The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy     was gradually reduced and stopped. Patients were followed-up regularly for the next 18     months.   "
89570|NCT02113696|"     Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly     obese patients, will improve the inflammatory status? C-reactive protein? Weight?   "
89571|NCT02113683|"     The purpose of this study is the validation of MMS test to detect active tumor growth in     different cancer types before and after therapy, as well as in the course of therapy and for     subsequent relapse control compared to standard methods (clinical examination, imaging, tumor     markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and     thus can replace more expensive or invasive procedures in future.   "
89572|NCT02113670|"     More than 11 million women in the United States suffer from stress urinary incontinence     (SUI), the involuntary leakage of urine during everyday activities that put temporary stress     on the abdomen and bladder, such as laughing, coughing, and walking. For women with SUI, this     pressure often causes urine to leak involuntarily. SUI affects women of all ages including     young mothers, pre-menopausal women, and seniors, and can result in significant emotional     distress. Current solutions for SUI include disposable pads, behavioral treatment (pelvic     floor physical therapy) and surgical intervention. Patients with SUI who failed conservative     treatment and wish to be further treated by a surgery may require further work-up by     urodynamic study in which abdominal leak point pressures (ALPP) defined and reflect the     severity of SUI.      There is continuous need to develop less invasive treatments for SUI that could minimize the     use of pads, could be an alternative to painful, costly surgical procedure. The Trendlines     Group lab solution is a non-surgical alternative in the treatment of SUI. The concept of the     future treatment solution is based on simple physics: injecting a small amount of air into     the urinary bladder, which eliminates or greatly reduces involuntary urinary leakage. The air     bubble acts as a shock absorber to reduce the temporary pressure increase in the bladder     that causes urinary leakage. The concept for the new treatment has been tested in a lab     environment using lab jig tests and pig urinary system (bladder and urethra). The lab tests     showed significant improvement in the bladder pressure when the treatment was implemented by     suspending the stress pressure to a level that will not cause urine leakage.   "
89573|NCT02113657|"     The goal of this clinical research study is to study the impact of ipilimumab on the immune     system of patients currently receiving hormone therapy. The safety of these drug combinations     will also be studied.   "
89575|NCT02113631|"     1. The primary objective is to study the comparative effectiveness and tolerability of          boceprevir vs. telaprevir in HCV treatment, within the VA population.        2. The secondary objective:             -  Resource use: recording of differences in resource use, such as direct costs (e.g.,               drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as               the study will not only derive data by comparing those two drugs but also study the               effect on different treatment lengths.   "
89576|NCT02113618|"     To purpose of the present study is to investigate the feasibility and efficacy of a     computerized working memory training in improving cognitive functioning and alcohol use     outcomes, in individuals with alcohol use disorders.   "
89577|NCT02113605|"     The purpose of the trial is to develop a treatment protocol to be used in trials studying     internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The     study size is not based on power calculations but the estimated sample necessary to develop a     treatment protocol. This study will include 20-30 children with FGID and their parents who     will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of     exposure-based CBT. The study uses a pre- post-design with no control group.   "
89578|NCT02113592|"     The overall aim of this study is to adopt an integrative rehabilitation approach for helping     patients adopt self-management skills for managing chronic pain, limiting use of opioid     medications, and identifying exacerbating factors amenable to treatment (e.g., depression,     sleep problems) that is feasible and sustainable within the primary care setting.   "
89579|NCT02113579|"     This study is for people with sensitive teeth and involves going to the dentist for 4 visits     over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of     participants, and check for sensitive teeth.      During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride     toothpaste provided.      Then, if they qualify to continue in the study, participants will be assigned to one of two     treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently     sold on the market. Both groups will each have an investigative mouth rinse to use as well.     Participants will have an equal chance of being assigned to any one of the three groups.      For the next 4 weeks, participants will use their assigned products according to the     directions provided. At Visit 1, participants will be supervised while they brush their teeth     to ensure they understand the directions. They will also have supervised use of the products     at Visit 2.      Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity     during the study.   "
89580|NCT02113566|"     The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo     in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety:     There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus     and both will be well tolerated.   "
89593|NCT02113397|"     The purpose of this study is to characterize bacterial diversity and richness in the sputum     of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous     alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).   "
89583|NCT02113527|"     Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms from the     gastroduodenal region in the absence of any organic, systemic or metabolic disease that is     likely to explain the symptoms. FD can be further subdivided into two diagnostic categories:     postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS).      Disorders of gastric electric activity and abnormal gastric emptying are probably actively     involved in the FD onset. Different noninvasive procedures may be applied in order to     evaluate the gastric motor functions such as 13C breath testing and cutaneous     electrogastrography. Besides, different gastrointestinal peptides (i.e. CCK, peptide YY,     Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II) are     involved in the control of gastroduodenal motility.      Aims of the present study are: 1) to evaluate the GI peptide circulating concentrations, the     gastric electrical activity and gastric emptying time by applying noninvasive procedures in     patients suffering from functional dyspepsia and 2) to test whether a significant difference     exists between the two diagnostic categories of meal-induced dyspeptic symptoms   "
89584|NCT02113514|"     Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if     Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to     the increased risk of cervical abnormalities, specifically cancer, in their communities.   "
89585|NCT02113501|"     Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of     progression to invasive disease. Because the depth of substaging seems to identify two     separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a     differential treatment strategy for each group. The main hypothesis is that HighGradeT1a     bladder cancer can spare a second endoscopic procedure.   "
89586|NCT02113488|"     Our aim was to identify the causes non-attendance at scheduled appointments at the Clinical     Medicine Outpatient care system at the Italian Hospital of Buenos Aires (HIBA).   "
89587|NCT02113475|"     Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The     Registry will track patient outcome and quality of life over 60 months for treatment with     anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in     accordance with current treatment guidelines .   "
89588|NCT02113462|"     The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of     insulin resistance and an independent predictor of cardiovascular risk. The investigators     aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in     patients with CKD.   "
89902|NCT02109341|"     At this moment, FOLFIRINOX is the best treatment for selected patients (pts) with metastatic     pancreatic cancer (mPC). Investigator would like to evaluate the substitution of CPT11 or     Oxaliplatin in FOLFIRINOX schedule with Nab-paclitaxel (Nab-p) [Nab-FOLFIRI and Nab-FOLFOX].      Doses for Nab-FOLFIRI and Nab-FOLFOX will be determined by the phase I trial. One or both     schedules will be evaluated in successive phase II part.   "
89589|NCT02113449|"     Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues     and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic     rhinitis have shown that nasally administered CO2 may provide relief of the associated     symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration,     and may persist for four to six hours.      This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as     evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who     qualify and choose to participate in the clinical study will be administered nasal CO2 under     medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for     self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and     completion of assessment questionnaires.   "
89590|NCT02113436|"     This study is a multicenter, stratified, randomized, active control, double-blinded,     parallel-group comparative study with an open-label extension period. The study is designed     to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two     inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two     inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study     is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg     one or two BID for 16 weeks.      The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and     receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The     subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in     period. The subjects who meet the eligibility criteria for randomization will be stratified     according to their age (<2 or >=2 year-old) at Visit 1 and randomized to one of the two     treatment groups.      The total duration of participation in the study will be 10 weeks for a comparison period     completion and 27 weeks for a completion.   "
89591|NCT02113423|"     The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned     four modalities for rT1-2 NPC.      Characters of the patients:        -  list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC          were diagnosed        -  list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT          Combined 3D-CRT or IMRT).        -  list item three: Median time to recurrence was 30 months (range 1-180months). The median          follow-up time was 28 months (range, 4-135 months).   "
89592|NCT02113410|"     The current study is a randomized controlled clinical trial to test the feasibility of     recruiting, randomizing, and having older adults with osteoarthritis (OA) adhere to and     safely complete the Sit 'N' Fit Chair Yoga program and the HEP program (primary objective).     Secondary objectives of the study are to determine the effect of the Sit 'N' Fit Chair Yoga     Program to reduce levels of pain; improve physical function, psychosocial function, and life     satisfaction in adults over 65 years of age who are unable to participate in standing     exercise. Participants at two sites will be randomly assigned to either the intervention     group (Sit 'N' Fit Chair Yoga) or attention control group (Health Education Program). Data     collectors will be blinded to group assignments. Data will be collected prior to the     intervention (baseline), after 4 weeks, and after 8 weeks. Follow-up data will be collected     after 1 month and after 3 months after completion of the intervention to measure the extent     to which effects of the intervention continue. Evaluations will include physical measures and     self-report measures.   "
89594|NCT02113384|"     During the course of tumor growth and possibly by manipulation during the surgical procedure,     cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to     local recurrence or contribute to the formation of metastatic disease, specifically in the     form of peritoneal carcinomatosis. Detection of cancer cells in the peritoneal cavity at the     time of surgery might therefore be of value for prediction of disease recurrence with     subsequent prognostic implications for these patients. In this study the investigators aim to     determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients     undergoing surgery for LARC.   "
89595|NCT02113371|"     The current project is a safety and health intervention for home care workers conducted     within the Oregon Healthy Workforce Center (OHWC), a NIOSH Center of Excellence in Total     Worker Health.      The objective of this five-year project is to create sustainable health and safety     communities of practice within a population of typically isolated home care workers. The     intervention is a team-based, peer-led scripted curriculum that integrates health promotion     and protection topics, as well as proven elements of social support groups for caregivers.     The investigators hypothesize that this intervention will increase measures of experienced     community of practice, well-being, and diet, exercise, and safety behaviors, as compared to a     usual practices control condition.   "
89596|NCT02113358|"     Fluid management during neurosurgery presents a special clinical agenda. Volume overload can     have detrimental effects on intracranial pressure by increasing either cerebral blood volume     or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive     fluid strategy may risk hemodynamic instability.      Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have     been shown as a more precise parameters for fluid management including in neurosurgical     patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim     to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy.     Randomization will be generated by computer sampling. One of the two groups of patients will     be managed with fluid bolus to keep intraoperative SVV <10% presenting the normovolemia     group. The other group of patients will be kept intraoperative SVV <18% which is slightly     above previously reported SVV threshold upper limit. The second group thus presents the     restrictive group. Clinical outcomes, laboratory analysis including S100-B for neuronal     damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be     compared.   "
89597|NCT02113345|"     The purpose of this research is to explore the relationship of metamemory and memory of     elders and to evaluate the effectiveness of a metamemory cognitive intervention on elders     with mild cognitive impairment and low memory self-efficacy.   "
89949|NCT02108730|"     Observational study in patients with non-focal congenital hyperinsulinism showing that     restrictive surgery may improve the metabolic situation   "
89598|NCT02113332|"     Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients     on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight.     However, to date there are no clinical trials of liraglutide added to insulin therapy, a     population of patients generally having worse glycaemic control and weight gain. In clinical     guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic     option for type 2 diabetic patients.      The primary study aim is to evaluate whether the addition of liraglutide, compared to     placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with     inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is     defined as treatment with any basal insulin combined with separate meal time insulin     injections before the main meals, i.e. an insulin regimen with premixed insulin is not     considered as MDI.      The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.   "
89599|NCT02113319|"     In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal     Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also     increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal     Residual Disease level at the end of consolidation or in molecular relapse, maintenance by     the inhibitor dasatinib is proposed.   "
89600|NCT02113306|"     A recent study with rats showed that electrical stimulation of the vagus nerve (VNS)     facilitates extinction of fear (Pena, Engineer, & McIntyre, Biological Psychiatry, 2013). The     hypothesized mechanism is that VNS both enhances memory consolidation (by increasing     noradrenergic neurotransmission) and reduces anxiety (thus: preventing fear responses to the     CS which may re-consolidate the fear memory). The effect was only apparent when VNS occurred     during exposure of the fear conditioned stimulus (CS), and not when stimulation was given     immediately following exposure. These results may have implications for the treatment of     anxiety disorders in humans. However, until recently, the only means to investigate the     effects of VNS on human fear learning would have required the invasive implantation of vagus     nerve stimulators. This has fortunately changed, as a non-invasive transcutaneous VNS device     has been approved for use in the E.U. for the treatment of psychological disorders.      This study proposes to use a t-VNS to investigate its effects on fear learning and extinction     in (healthy) humans. Previous research has only investigated the effects it has on human mood     and memory. The results obtained suggest that it reduces negative affect and enhances memory,     findings which are consistent with those reported for rats. It is thus reasonable to expect     that t-VNS will facilitate the extinction of fear in humans.      The present study aims to answer the following research questions:      Does t-VNS during extinction training:        1. accelerates extinction curves        2. reduces spontaneous recovery of previously extinguished fear        3. reduce re-acquisition of fear        4. reduce generalization of fear to other stimuli that resemble the CS+?        5. facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?   "
89601|NCT02113293|"     This study is intended to investigate the tolerability and the safety of Cyclosporine A     containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy     volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo     (vehicle) in the first part (first period) of the study, and switched to the alternative     dosing in the second part (second period) of the study. An ophthalmological assessment of the     eyes will be performed, and a questionnaire will be issued in the beginning and after each     dosing. Additionally physical examinations, safety laboratory and ECGs will be performed, and     blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).   "
89602|NCT02113280|"     Patients with wear and tear in their knees (osteoarthritis) are often referred to orthopaedic     surgeons following a sudden worsening of pain and mechanical symptoms (grinding, locking,     giving way) in their knee due to tears of their meniscal cartilages. These tears are     described as degenerative as they are not usually caused by a single injury but rather     accumulation of wear and tear. It is not clear from the current available evidence what the     best treatment for these patients is. Their underlying arthritis is not bad enough to require     joint replacement yet and they were usually managing well with minimal problems from their     knee until experiencing the meniscal tear. However, some of their symptoms are likely to be     due to the arthritis rather than just the tear. Current treatment for these patients is     usually in the form of conservative treatment with physiotherapy and supervised exercise or     using arthroscopy (key-hole surgery) to trim the damaged area of the meniscus. We know from     previous research that most of these patients will improve over time to some extent but it is     not clear whether a greater improvement can be expected following surgery and if so, whether     this applies to all patients with this problem or not.      Our study is intended to compare the outcome of patients with proven degenerative meniscal     tears imaged on MRI scans, when they are assigned to arthroscopy followed by supervised     exercise or supervised exercise alone. They will be randomly assigned and the outcome will be     assessed using patient-completed questionnaires (Knee Outcome Osteoarthritis and injury Score     [KOOS], SF12, visual analogue score for pain) and whether the patients go on to require     further surgery during the period of the trial. The patients will be assessed at baseline, at     6 weeks, 6 months, 12 months and 24 months.   "
89614|NCT02113124|"     Years after a suffering a brain injury, individuals remain in a physically and cognitively     impaired state. The investigators believe that the concentrations of amino acids in the blood     are chronically altered and yield negative effects on the individuals health. Preliminary     data has shown significantly lower concentrations of amino acids in serum samples from the     TBI population, these diminished levels of amino acids may be due to changes in the     microbiome. Understanding these changes will help guide rehabilitative services for this     population. Individuals with a chronic brain injury will donate samples of blood, oral     tissue, and fecal matter to be compared to that of non-injured individuals. Genetic     information from the hosts will be striped and discarded; participant's genetic information     will not be retained. To better understand changes in the microbiome, any history of     antibiotics and probiotics will be assessed.   "
89878|NCT02109653|"     This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and     safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib     (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV)     BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous     systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.   "
89603|NCT02113267|"     Background:      Eosinophilic esophagitis ( EoE ) is a disease entity which has been properly recognized only     within the past two decades.(1) A prevalence of nearly 1% means that almost 20,000 people in     the Region of Western Sweden may be affected.(2 ) The main symptom is swallowing difficulty     and food may be stuck, which typically require acute hospital care with operational action     under general anesthesia.( 3,4 ) The standard treatment today is local treatment with     steroids by mouth several times a day for a few weeks.( 5 ) In adults and large teenagers,     there is only one randomized study which has shown that budesonide has a significant effect     exaggerating that of placebo. However, the main end-point in this study was the degree of     tissue inflammation.(6) In a separate study using validated questionnaires , we have shown     that patients with EoE have distinct organ-specific symptoms and a lowered quality of life .     These symptoms nearly disappeared, after treatment with mometasone furoate. However, as that     study was not randomized or placebo controlled no causal conclusions could be drawn regarding     the treatment effect, but the method of validated questionnaires proved sensitive to changes     in symptomatology.(7) Purpose The primary purpose of this study is to evaluate the effect of     local steroid treatment with mometasone furoate on swallowing problems in patients with EoE .     Secondarily, to evaluate the effect on patient quality of life and the presence of side     effects.   "
89604|NCT02113254|"     The Age Macular Degeneration (AMD) is the first cause of blindness in industrialized     countries. The macular pigment (lutein and zeaxanthin) could play an important role in the     arisen of the AMD. The food supplementation by corn with strong concentration in macular     pigment could increase the density of the macular pigment. This could, in the future,     represent a strategy of prevention of the AMD. The main objective of this study is to detect     an increase of the macular pigment density after the consumption of this corn at healthy     volunteers.   "
89605|NCT02113241|"     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult     population suffers the disease.      Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is     a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have     benefits on blood pressure, triglycerides levels and help to raise the levels of high density     lipoproteins cholesterol (c-HDL).      The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome,     insulin sensitivity and insulin secretion.      The investigators hypothesis is that the administration of dapagliflozin modifies the     metabolic syndrome, insulin sensitivity and insulin secretion.   "
89606|NCT02113228|"     This study proposes to verify the total energy expenditure in patients with short bowel     syndrome using the doubly labeled water method, as well as determining the rate of oxidation     of nutrients, aiming to assist the management of nutritional therapy for these patients.   "
89607|NCT02113215|"     Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals     relative to young people, despite no significant difference in fasting plasma TAG     concentrations. Our general hypothesis is that the increase in intrahepatic fat with age     results from reduced VLDL turnover, and therefore elderly individuals in this study will     display lower VLDL turnover rates than young individuals. The aims of this study are a) to     compare VLDL turnover in young and elderly individuals, and b) to compare a bolus method and     a constant infusion method of assessing VLDL turnover.   "
89620|NCT02113046|"     The aim of this study is to investigate whether finnish binding pancreatico-jejunal     anastomosis is feasible and prevents the risk for post operative pancreatic fistula after     distal pancreeatectomy.   "
89608|NCT02113202|"     There is a need for better visualization of polyps during surveillance endoscopy in patients     with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch     Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma     associated biomarkers is a promising technique to accommodate this need. The biomarker     Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus     normal tissue and has proven to be a valid target for molecular imaging. The University     Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting     humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the     fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is     administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma     visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform     (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the     determination of the optimal tracer dose.   "
89609|NCT02113189|"     The purpose of this study is to investigate the impact of a specifically designed leg brace     on walking endurance in individuals with Parkinson's disease.   "
89610|NCT02113176|"     The purpose of this study is to determine the safety and efficacy of a drug minocycline in     improving outcomes at 3 months after rupture of an aneurysm in the head.   "
89611|NCT02113163|"     The primary objective of the study is to contrast the pharmacokinetic profiles of metformin     and EPA delivered separately as co-administered products (metformin hydrochloride or     Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin     eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to     evaluate the safety and tolerability of single and repeat single doses of TP-101.   "
89612|NCT02113150|"     In this prospective, randomized, clinical trial, we have investigated the effects of     ketamine-based and remifentanil-based anesthetic protocol on perioperative serum cystatin-c     levels, and creatinine and/or cystatin-c based eGFR equations in terms of acute kidney injury     in CABG surgery.This study was approved by the Ethics Committee of Hospital and all patients     were informed and gave written consent. Patients scheduled for elective CABG with     cardiopulmonary bypass. Patients were randomly allocated to anesthesia with     remifentanil-propofol-midazolam (RPM) group or ketamine-propofol-midazolam (KPM) group. Blood     samples were obtained before induction of anesthesia (baseline), at the end of the operation,     and postoperative days 1, 2, and 4.   "
89613|NCT02113137|"     The purpose of the study is to evaluate the effect of various oral hygiene procedures on     reduction of oral malodor.   "
89680|NCT02112266|"     One Aim of the current study is to better understand why some patients suffering from     depression do not seek professional help by doctors but in the internet.      Furthermore patients with depression will receive Online Therapy for depression. Aim of this     part of the study is to investigate whether quality of life changes accordingly to     improvement of symptoms after online therapy.   "
89615|NCT02113111|"     The study aims to investigate        -  if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with          chronic diseases        -  the effects of fasting on physical and mental well-being, quality of life and body          awareness/image        -  the association between patients characteristics and the perceived health benefit after          fasting        -  the association between Diagnosis according to traditional Chinese medicine and physical          and mental well-being during the course of fasting        -  experiences and perceptions of patients during fasting therapy   "
89616|NCT02113098|"     The purpose of this study is to determine whether the add load on non-paretic lower limb of     individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait     symmetry of these individuals, in a subacute phase of stroke.   "
89617|NCT02113085|"     The purpose of the study is to implement a full-scale efficacy trial of the My Life program.     Conducted in partnership with the Oregon DHS Foster Care Program, the impact of the     intervention will be being evaluated with a randomized experimental longitudinal design. Two     hundred and ten youth, ages 16.5-17.5, will be enrolled in 3 waves, and randomly assigned to     either a comparison group that receives typical foster care services or to a treatment group     that participates in the key elements of the model, including instruction in     self-determination skills, support in leading their own coordinated inter-agency transition     planning meetings, and participation in workshops with mentors. Outcomes, including youth     self-determination, quality of life, employment, mental health, educational achievement and     independent living, are assessed pre-intervention, at the conclusion of intervention, and at     12 months post-intervention. The proposed study will provide important information on the     efficacy of the model for all youth exiting the foster care system, yielding unequivocal data     on whether enhanced self-determination mediates, at least partially, various outcome areas,     including mental health, educational achievement, employment, independent living, and quality     of life; evaluating the effect of special education status, gender, and race as moderating     influences on the impact of the intervention. Foster care experiences, such as trauma and     placement instability, will be considered as covariates; direct effects of the intervention     on these key foster care experiences will also be explored.   "
89618|NCT02113072|"     The purpose of this study is to evaluate whether Probiotics promote reduction of recurrent     wheezing in infants, stimulating the immune system to Th1 response.   "
89619|NCT02113059|"     The most relevant factor predicting morbidity and mortality after liver resections is the     ability of the remnant liver to regenerate. The investigators recently demonstrated that     serotonin and thrombospondin-1, two growth factors abundantly stored in platelets, seem to     play a critical role in liver regeneration of patients after liver resection. The     investigators now aim to gain more precise insight concerning the relevance of platelets and     platelet derived growth factors in liver regeneration in humans. The investigators will focus     on specific alpha-granula release as a key regulator of postoperative LR. Using peri- and     intraoperative blood and tissue samples, platelet adhesion, granula release and induction of     gene expression known to be involved in liver regeneration form experimental studies will be     analyzed. This study should allow the investigators to verify observations from preclinical     models and evaluate their relevance in the human setting. Furthermore, this might enable the     investigators to identify new therapeutic targets.   "
89629|NCT02112929|"     The investigators aim to use hyperpolarized xenon gas magnetic resonance imaging (MRI) and     computed tomography to develop a new technique capable of objectively and quantitatively     describing regional and structural lung abnormality. Since this is a relatively novel     technique, the investigators first need to acquire imaging and clinical data from a group of     participants with normal lungs. The investigators hope to generate an atlas of normality,     which will form the foundation of future studies to compare with patients suffering from     chronic respiratory disease. The investigators also aim to validate the new technique in     terms of intra-subject reproducibility.   "
89734|NCT02111564|"     The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with     placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related     death post-hospital discharge in high-risk, medically ill patients.   "
91390|NCT02089867|"     The purpose of this study is to determine the effect of plant sterols associated with     ezetimibe in LDL-cholesterol levels in coronary patients previously on statin therapy   "
89631|NCT02112903|"     The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea,     vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following     single oral doses of three modified-release (MR) capsules with differently coated multiple     particles compared to one immediate-release (IR) tablet.   "
89632|NCT02112890|"     This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV)     and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.   "
89633|NCT02112877|"     This is a multi-center, prospective, single arm, non-randomized study to evaluate safety and     efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective     Performance goals. The follow-up period is 60 months.   "
89634|NCT02112864|"     Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery.     Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a     significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of     this study is that dexamethasone, given pre operatively, would help reduce the incidence of     post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory response,     in patients undergoing elective thoracic surgery that includes thoracic epidural analgesia.   "
89635|NCT02112851|"     Randomized, placebo controlled, double blind, postprandial crossover study in male subjects.     3 intervention arms, consisting of a control (Product A), a low dose processed whole orange     (Product B) and a high dose processed whole orange (Product C), to determine the effect of     the interventions on the primary endpoint of postprandial glycemia. Secondarily, plasma     insulin concentrations will be quantified.   "
89636|NCT02112838|"     The purpose of this study is to determine whether fostamatinib is safe and effective in the     treatment of IgA Nephropathy   "
89637|NCT02112825|"     The general objective of the study is to investigate the effect of regular aerobic exercise     on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and     hypertension.   "
89638|NCT02112812|"     A higher prevalence of Helicobacter pylori infection rate has been demonstrated among PD     patients compared to controls. As H. pylori infection is known to interfere with levodopa     absorption, we embarked on this is a study to understand the effects of Helicobacter pylori     infection eradication among a selected Malaysian population with Parkinsons disease, in     relation to levodopa effectiveness and motor improvements.      The study hypotheses are:        1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time'          duration.        2. PD patients with H. pylori infection show clinical improvement in motor disability and          quality of life after eradication therapy of H. pylori, assessed using UPDRS-III / PDQ39          questionnaires.   "
89639|NCT02112799|"     This Phase 1 trial will assess the dose-related safety and PK profile of different doses of     NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with     chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA     levels and other virologic efficacy parameters will be assessed.   "
89640|NCT02112786|"     Participants receiving neuromodulation treatment for overactive bladder symptoms will be     routinely fitted with an impulse generator. However, the setting on the impulse generator     will be set to either intermittent or continuous stimulation. Participants will complete     voiding logs and surveys for a month. Battery life will be interrogated.After a one week     period were the device is turned off, the impulse generator will be turned to the opposite     setting (intermittent or continuous) and the one month period will be repeated. Again,     voiding logs, surveys, and battery life will be collected.      The purpose of this project is to investigate the outcomes of intermittent versus continuous     stimulation in patients treated with sacral neuromodulation (SNM) for refractory overactive     bladder (OAB) syndrome. In addition, the potential for an improved battery life with     intermittent stimulation will be quantified.   "
89641|NCT02112773|"     The objectives of this study is to assess the characteristics and frequency of adenovirus     conjunctivitis in a population of male and female patients from one year of age who present     signs and symptoms of acute conjunctivitis.   "
89647|NCT02112695|"     Abnormal opioid system have been identified in addictive behavior and activity of the opioid     system has also shown a strong link with the nutritional balance. A significant increase in     endorphin levels was noticed after exercise, proportional to the duration and intensity of     this activity. One brain imaging study showed an increase in opioid activity in athletes     after endurance training. However , a decrease in opioid tone related to receptor     desensitization in the brain has been raised in the sport and it is possible to feel like ,     the subject must perform physical exercise more frequently . Consequently, in order to deepen     the hypothesis of addiction in high-level sport , the brain opioid activity should be     assessed pre- training compared to a group of sedentary control subjects .      Preliminary results of a previous study the investigators are conducting on anorexia nervosa     (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and     the regulation of gonadal function. However, the relation of cause and effect between these     anomalies and undernutrition remains to be determined . Given the addictive component in the     endurance sport and the variability of the nutritional status of its practitioners ,     evaluation of brain activity in these subjects could provide additional answers.   "
89642|NCT02112760|"     1. Specific aim 1:Identify factors that influence muscle performance by use of ultrasound          imaging.           Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.        2. Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis          and multifidus) and the sensation and pain thresholds of patients with recurrent low          back pain with asymptomatic subjects.           Hypothesis: patients with recurrent low back pain have:           (A) less activation of the transversus abdominis and multifidus, (B) peripheral and          central sensitization, with decreased sensation and pain thresholds in the lumbar and          foot areas.        3. Specific aim 3. To determine the performance of the transversus abdominis and          multifidus, and the sensation and pain thresholds by use of ultrasound feedback training          in asymptomatic adults, and to compare these results with the traditional training          protocols for trunk stabilization.           Hypothesis: Specific stabilization exercise using ultrasound feedback training is more          effective in activating deep trunk muscles and increasing sensation and pain thresholds          than the traditional stabilization training protocol in asymptomatic adults.        4. Specific aim 4. To determine the performance of the transversus abdominis and          multifidus, and the sensation and pain thresholds by using the ultrasound feedback          training in adults with low back pain, and to compare these results with the traditional          training protocols for trunk stabilization.      Hypothesis: Specific stabilization exercise using ultrasound feedback training is more     effective in activating deep trunk muscles and increasing sensation and pain thresholds than     the traditional stabilization training protocol in adults with low back pain.   "
89643|NCT02112747|"     This randomized clinical trial studies website access or genetic counseling with or without     patient navigators on adherence to colorectal cancer screening recommendations in patients     with newly diagnosed colorectal cancer and their first degree relatives. Websites for     colorectal cancer prevention and genetic counseling may be effective methods to help people     learn about cancer screening. Patient navigators may improve adherence to colorectal cancer     screening recommendations. It is not yet known whether website access or genetic counseling     is more effective with or without patient navigators.   "
89644|NCT02112734|"     There is an urgent need to prevent the onset and progression of food allergy in our     population. Evidence demonstrates that food allergy and atopic eczema represent the earliest     manifestations of the atopic march with 50% of infants with food allergy predicted to develop     respiratory allergic diseases later in life. We report that Australia has the highest     prevalence of IgE-mediated food allergy in the world, with 10% of infants having     challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital     admissions for life-threatening anaphylaxis. These changes are most pronounced in children     less than 5 years, suggesting a causal role for early life determinants. We have primary data     to inform hypotheses for the rise in food allergy, which appears to result from potentially     modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency     (VDI), and have demonstrated an association between VDI and increased risk of     challenge-proven food allergy in 12-month old infants, which supports numerous ecological     studies showing an increased risk of food allergy the further a child resides from the     equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's     sunny climate, population rates of VDI have steadily increased in infants and pregnant women     in parallel to the apparent rise in food allergic disease. This association is biologically     plausible, as there is evidence Vitamin D is critical to the healthy development of the     immune system in early life. We propose an intervention study to assess if infant Vitamin D     supplementation during the first year of life significantly decreases the risk of early-onset     food allergy. Australia is ideally placed to answer this important question since, unlike the     USA, Canada and Europe, there are no population recommendations for routine infant     supplementation with Vitamin D and we are one of the few developed countries that do not     supplement the food chain supply with Vitamin D.   "
89645|NCT02112721|"     The aim of this study is to determine whether vitamin D supplementation in overweight/obese     individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance     by decreasing subclinical inflammation.      Results of the present study may help to identify new strategies to prevent type 2 diabetes     in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong     family history of diabetes).      Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for     type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve     insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical     chronic inflammation.      Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals     with low vitamin D levels will:        1. improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function        2. determine whether this relationship is mediated by a reduced chronic inflammation   "
89646|NCT02112708|"     Introduction: Minor psychiatric disorders are important in primary care, because of its high     prevalence and consumption of healthcare resources generated.      Objective: Evaluate the effectiveness of rational emotive behavioral therapy (REBT), as an     instrument of social work intervention to enhance changes in the parameters of quality of     life, medical consultations and drug use in patients with dysthymia.      Design: Multicenter, prospective, not randomized clinical trial, with intervention and     control group simultaneously in urban primary care settings and 1 year of follow up.      Participants: Out-patients seen in two Primary Care centers diagnosed with dysthymia     according to DSM-IV classification of American Psychiatric Association.      Intervention: Subjects receive up to 8 biweekly individual sessions of thirty minutes of REBT     administered by the Social Worker.      Variables: Demographic data, educational level, coexistence, comorbidity, quality of life     assessment, severity of depression, number of visits to the General Practitioner (GP) and     drug consumption: sedatives / antidepressants.      Expected Results: The expected results of the intervention, estimated from previous data,     are:        -  A decrease in attendance at medical visits per year        -  An improvement in perceived quality of life, measured as values of the Quality of Life          (QOL) questionnaire (Baker & Intagliata)        -  An improvement in severity of depression, measured according to the Beck Depression          Inventory.        -  A reduction of treatment with psychotropic drugs (sedatives and antidepressants).      Potential impact expected: The investigators hope that rational emotive theory is an     effective intervention method for handling minor psychiatric disorders in clinical social     work.   "
89658|NCT02112552|"     This pilot, phase II trial studies the side effects and how well paclitaxel given into the     vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed by     radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer. Drugs     used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells, stopping them from dividing, or stopping     them from spreading. Giving the drugs in different ways may kill more tumor cells. Radiation     therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy followed by     radiation therapy may be an effective treatment for uterine cancer.   "
89648|NCT02112682|"     STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the     axilla, in order to positively influence the axillary morbidity rate and quality of life.      PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior     to the current axillary treatment regimen in sentinel node positive breast cancer patients     undergoing a mastectomy, in terms of regional recurrence rate.      HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive     breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary     morbidity rate and to an increased quality of life, with non-inferior regional control,     distant-disease free- and overall survival rates.   "
90044|NCT02107547|"     The purpose of the study is to determine which of the two alternative surgical interventions     (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior     Labrum Anterior and Posterior lesions.   "
90045|NCT02107534|"     Children with dyslexia show a variety of comorbid disorders like behavior and adaptive     disorders, hyperkinetic and anxiety disorders. Raising and educating a child with dyslexia is     a challenging task for parents. Studies show that parents of children with dyslexia suffer     under depressive symptoms and higher parenting stress. In order to support the child's     academic development many parents of children with dyslexia practice reading and writing more     often and show controlling and maladaptive behavior. As a result learning motivation of the     child decreases and later homework situations are influenced in a negative way.      Consequently, it is necessary to provide parent training on appropriate behavior with     homework and academic exercises, in order to raise parent's competences, reduce parenting     stress and promote learning motivation of the child. In the German-speaking area there is a     lack of elaborated and evaluated programs for parents of dyslexic children. Therefore, a     group program that especially addresses the needs of these parents was devised. The study     aims at evaluating the effects of the parent training. We hypothesize that the treatment     reduces parenting stress and raises competences of the parents.      Forty-one mothers of third graders with dyslexia were randomly assigned to the group-based     parent training program (N=25) or a waiting list control group (N=16). Only children who     performed in the normal range on the test measuring cognitive abilities (IQ > 70) and who     scored below average in at least one test measuring reading or writing (T-Score < 40) were     included. Children with significant deficits in hearing or vision, pervasive developmental     disorder or genetic disorders were excluded. Data of children and their mothers were     collected prior to intervention, directly after intervention and three months after     intervention. For investigating training effects at all time points parenting stress and     competences in supporting academic development, mastering homework situations and attachment     to the child were measured. Parents of the waiting list control group had the possibility to     take part in the parent training after the follow-up was completed.      The intervention program consists of five two-hour sessions held biweekly. The training lasts     about 10 weeks. It is designed for group sizes of three to ten persons. It follows a     cognitive-behavioral approach. The training aims at knowledge transfer about dyslexia,     raising parent's empathy for the child's difficulties in reading and writing, promoting     parent's competencies and self-efficacy in handling dyslexia within the family context and     during homework situations, sensitization for opportunities of integrating reading and     writing into daily life and reduction of parental stress. The main topics covered are     requirements and phases of acquisition of written language, the causes of dyslexia, helpful     strategies for managing homework and exercises, facilitation of literacy in everyday life and     dealing with dyslexia. Methods used are brief lectures, example cases, group discussions and     practice, as well as homework tasks. Written handouts summarizing important topics are given     at every session.      A benefit of enrolling in the study is that parents get information concerning the academic     development of their children. At the moment it is not sure whether parents profit from     participating in the training because effects have not been investigated yet. The study takes     place at the University of Heidelberg (Children's Hospital) and the Early Intervention Centre     in Heidelberg. The study started in January 2012 and is expired to end in October 2014.     Participants have been recruited two times, at the beginning of a school year. The timeline     for every study flow was similar. Pretests took place in September and October; parent     training started in December and lasted until February. Post-Test took place in February and     March. Follow-Up measurements were realized from June to July. The study is funded by the     Günter Reimann-Dubbers foundation of Heidelberg. The main contact for the study is Bettina     Multhauf (M.Sc. Psych.), e-mail: fruehinterventionszentrum@googlemail.com   "
89649|NCT02112669|"     This study is a prospective, multi center, randomized, controlled study of the VasQ in     arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the     fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These     geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence     and promote laminar flow. The device is designed to improve short term maturation and long     term patency of the fistula. The VasQ is a permanent implant intended for use as a     subcutaneous arteriovenous conduit support for vascular access.   "
89650|NCT02112656|"     The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal     doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when     used in conjunction with standardized radiofrequency ablation (sRFA).   "
89651|NCT02112643|"     The purpose of this study is to determine whether sodium selenite is helpful in the treatment     of mild thyroid eye disease in North America.   "
89652|NCT02112630|"     The purpose of the study is to assess the safety and efficacy of triple therapy with     pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic     Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).   "
89653|NCT02112617|"     This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a     possible treatment for neuroblastoma.      Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the     top of the kidneys. However, it can also occur in other areas where groups of nerve cells     exist, such as other areas of the abdomen, neck and near the spine.      Conventional radiation therapy with photons is used as standard treatment for many patients     with neuroblastic tumors. In this research study, the investigators are looking at another     type of radiation called proton radiation which is known to spare surrounding tissues and     organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring     radiation. This may reduce side effects that patients would normally experience with standard     radiation therapy or other means of delivering proton radiation therapy.      In this research study, the investigators are evaluating the effectiveness of using proton     radiation delivered to reduce side effects associated with radiation treatment. The     investigators will also be assessing the late side effects experienced by participants in     each treatment group.   "
89654|NCT02112604|"     This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary     objective of this study is to examine factors that are related to sleep-disordered breathing     and upper airway patency in critically ill patients who have been recently mechanically     ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given     in the ICU prior to extubation and during the first night following extubation are associated     with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical     ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during     the night after extubation.      The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be     predicted by standard pulmonary function testing in the ICU.   "
89655|NCT02112591|"     Introduction:      Minimally invasive procedures TOT (tension-free suburethral tape using transobturator     approach)have been the standard for correction of SUI. However, around 28% of these patients     exhibit alteration of urinary flow. Recently, in 40 patients who underwent open surgery, an     abdominal fascia tape was placed in a subtrigonal position with a success rate of 87.5%     without obstruction. Our intention is to make the most of the idea of subtrigonal position in     minimally invasive procedures with transobturator polypropylene vaginal tape (S-TOT).      Object of the Study: To evaluate the efficacy and security of S-TOT compared with TOT.      Materials and Methods:      Study Population:      Patients of the Mexican Institute of Social Security (IMSS) with an SUI diagnosis.     Eligibility requirements: history of at least 3 months with symptoms of isolated SUI or     symptoms of SUI associated with urge urinary incontinence (mixed UI). The size of the sample     was estimated 34 subjects are required per group.      Study Design:      It is a parallel group randomized clinical trial. Success (efficacy) will be defined as when     the SUI has been corrected with negative pad test and normal urinary flow.      The results (efficacy) will be compared between the two groups using chi2 (group a/b versus     success/lack of success). In all cases, p <0.05 will be considered significant.      The data will be obtained with clinical evaluation, laboratory and radiological/imaging tests     and the respective questionnaires during the visits before surgery, and at 2 and 6 weeks, and     6, 12, and 24 months after surgery.   "
89656|NCT02112578|"     -  Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate)          to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of          treatment;        -  Evaluation of impact on quality of life in vertigo;        -  Compare the intensity of daytime sleepiness in the two treatment groups;        -  Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;        -  Compare the duration of treatment in both treatment groups;        -  Compare Adehence;        -  Compare the level of satisfaction from each group from the investigators and the          subjects;        -  Adverse events;   "
89657|NCT02112565|"     This phase I trial studies the side effects and best dose of City of Hope 29 (COH29) in     treating patients with solid tumors that are refractory to standard therapy or for which no     standard therapy exists. COH29 may inhibit an enzyme called ribonucleotide reductase and may     interfere with the ability of tumor cells to grow.   "
89659|NCT02112539|"     The study is to characterize the AggreGuide ADP Assay's performance.   "
89661|NCT02112513|"     The objective of this project is to evaluate clinical significance of measuring maternal     blood estriol levels, after the administration of antenatal corticosteroids to enhance lung     maturity. The investigators will test for associations of the change in maternal estriol with     the development of respiratory distress syndrome. The investigators are also interested in     determining whether salivary estriol is a valid surrogate to estriol blood assays. In     addition the investigators will correlate these changes to pharmacokinetic (PK),     pharmacodynamics (PD), and pharmacogenetic measures of betamethasone administration and fetal     respiratory outcome   "
89662|NCT02112500|"     Although the advent of advanced medical support for respiratory failure, the mortality rate     of acute severe respiratory failure is still high and the life quality is frequently     compromised from pulmonary fibrosis.      The investigators hypothesize that the treatment using mesenchymal stem cell can be     beneficial in patients with respiratory failure. The present study is a pilot study     evaluating the efficacy and safety of mesenchymal stem cell treatment in patients with     respiratory failure.   "
89663|NCT02112487|"     Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in     patients with PAH.      To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension     (PAH) beyond treatment in the AC-055-310 study.   "
89664|NCT02112474|"     Electrical stimulation of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief     has been used for decades. It is used most commonly in patients with chronic neuropathic leg     pain, after spinal surgery. Conventional neurostimulation is applied in frequencies of 30 to     60 Hertz (Hz) and perceptible paraesthesias are felt. Stimulation using higher frequencies     with sub perception paraesthesias has recently challenged the conventional form of     neurostimulation.The high frequency stimulation appears to show better pain relief for both     back and limb pain in comparison to low frequency SCS, and may also to be effective in some     subjects who did not respond to low frequency SCS.   "
89665|NCT02112461|"     Improving end-of-life care and the suffering caused by poorly controlled symptoms is an     important public health concern. The development of an automated telephone symptom monitoring     and support system that assists caregivers in providing end-of-life care and communicating     information to the patient's hospice nurse has the potential to enhance the management of     common end of life symptoms, thus reducing the suffering of patients at end of life as well     as the suffering of their family caregivers. This study has developed such a system and is     testing the effectiveness of this system.   "
89666|NCT02112448|"     The investigators hypothesize that intermittent bolus doses of morphine and midazolam can     provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus     infusions while using smaller total doses of both medications.      The investigators will randomize patients to receive either morphine/midazolam as needed     intermittently or morphine/midazolam drips plus intermittent doses to be received as needed.     Pain scores will be recorded and total medications given will be recorded.   "
89667|NCT02112435|"     Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder     disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP)     therapy is the standard treatment, but in some cases, it can not be used (patient refusal or     intolerance). In these cases, treatment with mandibular advancement devices can bring an     improvement in symptoms. Therefore, this study aims to compare the effectiveness of     titratable versus active mandibular advancement splints in standard care environment. This     will be based on the global response, which includes the apnea-hypopnea index and compliance     in severe apnea patients who refused or where intolerant to CPAP. Following their severe     apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement     device, follow-up visits will be scheduled after 3 months of treatment involving clinical     monitoring by a physician and a dentist.   "
89668|NCT02112422|"     The purpose of our study was to evaluate the hypothesis that single dose dexamethasone given     sixty minutes preoperatively reduces visual analog scale (VAS) pain scores and improves     quality of recovery in patients undergoing elective cesarean section as compared to the same     dose given immediately prior to skin incision.   "
89669|NCT02112409|"     Surgical correction of scoliosis with instrumentation carries significant blood loss and     needs for blood transfusion with its inherent risk and cost. In recent years, there is an     increased interest in utilizing autologous blood as part of perioperative blood conservation     strategy.      The foremost mechanical methods of perioperative conservation of red blood cells including     intraoperative cell salvage (ICS) and acute normovolemic hemodilution (ANH). They should be     considered in all cases where significant blood loss (>1000 ml) or >20% estimated blood     volume is expected, in patients with multiple antibodies or rare blood types and those who     refuse allogenic blood products.      Literature search has revealed that both cell salvage method and ANH utilized in elective     surgeries are capable of minimizing allogenic blood transfusion respectively. Surgeries which     are of significant relevance are aortic surgery, cardiac surgery and arthroplasty orthopaedic     surgery. Combining the above two techniques such as in ATIS trial 2002 also shows that it is     safe and significantly reduced allogenic blood requirements in aortic surgery. However till     date, there is still lack of strong evidence that autologous blood transfusion technique is     beneficial for scoliosis surgery in reducing allogenic blood transfusion.      Hypothesis:      The investigators hypothesize that the addition of ANH to ICS would confer additional benefit     than using cell saver alone. By combining cell saver with hemodilution technique, the     difference between pre-operative and post-operative Hemoglobin level will be smaller than     using cell saver technique alone, hence minimizing the variation in perioperative Hemoglobin     level - a predictor of allogenic blood transfusion.   "
89670|NCT02112396|"     The present study examines the efficacy of the Community Reinforcement and Family Training     (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders     (AUDs) using a randomized waiting list (WL) control group. It is hypothesized that after the     Intervention group has received CRAFT and prior to the WL- group having received CRAFT,     treatment utilization of individuals with AUDs are substantially elevated in the Intervention     group.   "
90046|NCT02107521|"     There is a lack of clarity regarding the justification to instruct the couple to shift from     intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm     injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with     previous implantation failure with ICSI.   "
89671|NCT02112383|"     Procrastination is defined as a voluntarily delay of an intended course of action despite     expecting to be worse-off for the delay, and is considered a persistent behavior pattern that     can result in major psychological suffering. About one-fifth of the adult population and half     of the student population are presumed having substantial difficulties due to recurrent     procrastination in their everyday life. However, chronic and severe procrastinators seldom     receive adequate care due to preconceptions and the lack of understanding regarding     procrastination and the treatment interventions that are assumed beneficial. Cognitive     behavior therapy is often deemed treatment of choice, although the evidence supporting its     use is scarce, and only one randomized controlled trial has been performed. The primary aim     of the current study is therefore to test the efficacy of cognitive behavior therapy     delivered as either a group intervention or via the Internet. Participants will consist of     students recruited through the Student Health Centre at Karolinska Institutet. A randomized     controlled trial with a sample size of 100 participants divided into two conditions will be     employed; a ten week Internet-based cognitive behavior therapy intervention, and an eight     week group intervention based on cognitive behavior therapy. The current study is believed to     result in two important findings. First, different interventions inherent in cognitive     behavior therapy are assumed to be helpful for people suffering from problems caused by     procrastination. Second, both a group intervention and an Internet-based cognitive behavior     therapy intervention are presumed suitable for administering treatment for procrastination,     which is considered highly important as the availability of adequate care is limited,     particularly among students. The current study will increase the knowledge regarding the     efficacy of different treatments of procrastination, as well as enhance the overall     comprehension of the difficulties related to dilatory behavior.   "
89672|NCT02112370|"     To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in     BABA endoscopic and robotic thyroidectomy.   "
89673|NCT02112357|"     This study will assess the feasibility of sequencing locally advanced/metastatic     gastrointestinal cancers in real-time to enable future treatment stratification by molecular     characteristics. Targeted next generation sequencing of a panel of genes will be performed on     tumour specimens and results will be discussed at a Sequencing Tumour Board to establish if a     patient is potentially suitable for a targeted therapy.   "
89674|NCT02112344|"     Squamous cell carcinoma of unknown primary (SCCUP) site metastatic to cervical lymph nodes at     presentation is a relatively rare entity forming about 2% of all head and neck carcinomas.      Typically patients are treated with ipsilateral modified radical neck dissection (MRND) and     post-operative radiotherapy (PORT) or chemoradiotherapy.      There is a lack of consensus on the radiotherapy target volumes that should be treated after     neck dissection. The most common radiotherapy techniques are either unilateral cervical lymph     node irradiation to achieve local control in the ipsilateral neck or TMI of the head and neck     region with the aim of eradicating the primary and the microscopic neck disease.      Treatment of the ipsilateral hemi-neck alone is of low toxicity and may achieve local control     in the cervical nodes. Potential occult primary sites in the head and neck mucosa, and any     sub-clinical metastatic disease in the contralateral side of the neck are left untreated. If     a primary tumour subsequently becomes apparent the previous radiotherapy may make further     radiotherapy difficult to deliver.      Some groups recommend bilateral neck and total mucosal irradiation in this setting claiming     improved local control. With conventional radiotherapy technique this is at the price of     significant acute toxicity and chronic morbidity, mainly xerostomia with its associated     complications and effects on quality of life (QOL).      Intensity modulated radiotherapy (IMRT) has been shown to reduce the dose to salivary gland     tissue and consequently may reduce the incidence of xerostomia and improve quality of life     (QOL) in head and neck cancer patients.      An analysis of parotid-sparing IMRT at the University of Michigan established a mean dose     threshold for both stimulated (26 Gy), and unstimulated (24 Gy) saliva flow rates. For the     same end-point (less than 25% of flow at baseline one year post radiation) Roesink et al     established a TD50 of 39 Gy.      The investigators performed a planning study to assess the feasibility of IMRT to spare the     parotid gland while delivering bilateral neck and TMI. The mean dose to the contralateral     parotid gland using IMRT was below the threshold of 24 Gy for unstimulated salivary flow,     predicting a fairly low risk of radiation induced xerostomia. The mean dose to the     ipsilateral parotid gland was 32 Gy which was below the TD50 dose based on the Roesink data.      This study assesses the safety and tolerability of delivering IMRT in clinical practice to     treat patients with SCCUP of the head and neck region, who require bilateral neck and     pan-mucosal irradiation.   "
89675|NCT02112331|"     The optimization of newborns nutrition is a challenge especially for preterm newborns for     whom nutrition plays a crucial part in cerebral and global development. Human milk is     considered as the best food for newborns. Several short and long-term beneficial health     effects were attributed to breastfeeding and have induced the increase of human milk in     preterm newborns nutrition.      Whereas the chemical composition of infant formula has been optimized to mimic human milk,     there is still a major difference between the structure of human milk and commercial infant     formulas. It is well known in adult nutrition that the structure of emulsions influences     their susceptibility to hydrolysis, such results have been obtained either on in vitro or in     vivo studies.      Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the form     of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The globules     are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids,     sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds.      The physical treatments apply to human milk or more generally to bovine milk to pasteurize or     stabilize the milk modify the structure of the natural emulsion. Heat treatment for instance     induces whey proteins denaturation and the adsorption of protein aggregates on the surface of     the milk fat globules. Heat treatment also leads to the denaturation of bile salt stimulated     lipase. These effects limit intragastric lipolysis in preterm newborns.      Conversely, reduction of milk globules size, by homogenisation of milk, increases the     specific surface available for lipase adsorption and limits the lost of fat during enteral     administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat     absorption of preterm newborns.      The objective of this trial is to evaluate the effects of physical treatments (pasteurization     and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk     destructuration. This trial is conducted, in vivo, on preterm newborns.   "
89676|NCT02112318|"     The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a     measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus     rhythm maintenance after electrical cardioversion.      Earlier studies performed in a retrospective fashion suggested that high AFR exceeding     350-360 fibrillations per minute is an independent predictor of AF relapse after     cardioversion, particularly in patients with duration of AF episode not exceeding 30 days,     however this hypothesis has not been tested in a prospective study.      CASAF is an observational study that will enroll patients with short duration (< 30 days) AF     admitted for electrical cardioversion. Admission ECG will be extracted in a digital format     and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks long     follow-up period during which ECG control will be scheduled at week 1 and 6.   "
89677|NCT02112305|"     The purpose of this study is to determine whether nebulized magnesium sulphate is effective     in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate   "
89678|NCT02112292|"     The endocannabinoid (eCB) system, a neurochemical signalling system consisting of     CB-receptors and their endogenous ligands, has been found to be involved in food intake of     sweet and palatable foods. Activation of the eCB system increases food intake and vice versa.     The mechanism behind this effect is still unknown and the current study aims at clarifying     why sweet food intake increases. It is hypothesized that sweet taste intensity increases and     that sweet taste is experienced as more pleasant.   "
89679|NCT02112279|"     Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that     can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005),     there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most     often associated with overuse of antibiotics. According to Bartlett & Gerding (2008), 15-25%     of anti-microbial-associated diarrhea is caused by C-difficile.      The purpose of this study is to determine if donor fecal microbiota transplant via     colonoscopy reduces refractory C-difficile infection better than current routine methods such     as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota     transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients     versus care as usual in a retrospective cohort.   "
89681|NCT02112253|"     The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation     of the anterior globus pallidus. The best area within this brain region and the best     stimulation device settings are currently unknown. This is a study in which deep versus     superficial electrode contact positions and two different amplitudes of stimulation are     compared under scientific conditions. The hypothesis is that one contact position/stimulation     amplitude combination will provide a better outcome than the others. Each study participant     receives each of four different anatomical position/stimulation amplitude setting     combinations over a 12 month period in randomized order followed by a 6-month period of     trial-and-error device programming to optimize control of motor tics. Motor tics, potential     side effects, daily functioning and quality of life are assessed at the end of each trial     stimulation period. At the end of the study, the study participant continues to have     long-term deep brain stimulation treatment with whatever settings provide the most relief.   "
89682|NCT02112240|"     The purpose of this study is to see if investigators can develop a technique to identify     sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer     (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible     patients are those with stage I-III rectal cancer undergoing standard low anterior resection     or abdominoperineal resection.      Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique     using a mobile gamma camera will identify the sentinel lymph node in patients with rectal     cancer with greater than 80% sensitivity.      Subjects will receive injections of the tracer and dye prior to surgery, have preoperative     SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to     their scheduled surgery. During surgery, images of the rectum will be taken with a unique     mobile gamma camera prior to removal and upon resection.      If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the     hope is to combine this technique with a less invasive surgery called transanal endoscopic     microsurgery (TEM) for early stage rectal cancer patients.   "
89683|NCT02112227|"     Heart failure (HF) is the most common cause of hospitalization in older adults. The month     after hospital discharge represents a vulnerable period, when patients are at increased risk     of death and readmission to hospital. Research has shown that certain discharge-planning     services can reduce death and readmissions, but these have not been widely implemented. In     this study, we will group evidence-informed discharge-planning services into     'Patient-centered Care Transitions in HF' (PACT-HF), a model of care that will prepare     patients for their transition from hospital to home. Through PACT-HF, patients will benefit     from a comprehensive assessment of their health care needs, learn to recognize and manage     symptoms of HF, and receive the information and follow-up care needed to optimize their     health. We will introduce PACT-HF to 10 Ontario hospitals over a number of time periods using     a stepped wedge cluster trial design. We will compare the outcomes (hierarchically ordered)     of patients in hospitals with PACT-HF to those in hospitals without PACT-HF. We anticipate     that patients hospitalized at the sites with PACT-HF will have fewer readmissions, emergency     visits, and deaths after discharge; report a better quality of life; and feel more prepared     for discharge. We also anticipate that overall, PACT-HF will reduce health system costs.   "
89684|NCT02112214|"     The aim of this study is to define the role of H. pylori eradication in the prevention of     gastric cancer and its precursors in the context of a population-based endoscopic screening     program.   "
89685|NCT02112201|"     Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and     trauma are particularly at risk for engaging in risky sexual behavior and for contracting     HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs     for girls who have this combination of behaviors is known to exist at this time. Researchers     are developing, assessing, and implementing a family-centered prevention program to decrease     girls' participation in the risky behaviors associated with the spread of HIV and STIs. The     program also includes a group-based training and support program for parents.   "
89686|NCT02112188|"     The purpose of the study is to modify a type of counseling called Individual Meaning     Centered Psychotherapy to meet the needs of Chinese cancer patients. Many cancer patients     use counseling or other resources to help cope with the emotional burden of their illnesses.     Counseling often helps them cope with cancer by giving them a place to express their     feelings. Meaning-Centered counseling aims to teach cancer patients how to maintain or even     increase a sense of meaning and purpose in their lives, despite cancer.   "
89687|NCT02112175|"     The purpose of this study is to compare the safety and efficacy of Lenalidomide versus     Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly     diagnosed multiple myeloma.   "
89688|NCT02112162|"     This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG)     positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment     response in patients with rectal cancer that has spread to nearby tissue or lymph nodes     undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in     the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid     (DNA) and may also help doctors predict a patient's response to treatment before surgery.     PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The     combined scans give more detailed pictures of areas inside the body than either scan gives by     itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and     radiation therapy and help the surgeon make the best plan for removal of the tumor.   "
89689|NCT02112149|"     The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG     exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.   "
89690|NCT02112136|"     The aim of this study is to identify families with ADPKD , characterize the phenotype and     screen for mutations in known genes (PKD1 and PKD2, and then HNF1b and UMOD in PKD1 PKD2     negative carriers).      Genome wide analysis will be performed in families without mutations identified.   "
89691|NCT02112123|"     The purpose of this study is to investigate the pharmacokinetic properties of icariin, an     active ingredient in the over-the-counter supplement, Horny Goat Weed.   "
89692|NCT02112110|"     The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of     BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.   "
89693|NCT02112097|"     AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only     automatic injection system for delivery of injectable products to the optimum spot, just     outside of the fascia, which exists subdermally (between the skin and muscle) or interfascial     (between the deeper muscles). ASIS device creates that bloodless space, enhancing Enbrel's     efficacy and preventing unnecessary distant spread and adverse reactions. This space remains     bloodless as long as the skin is lifted up or filled with an injectable product. Although     ASIS device was initially designed to best administer BOTOX for such muscular conditions as     Upper limb Spasticity, Cervical Dystonia, Chronic Migraine, Strabismus, Blepharospasm, and     Primary Axillary Hyperhidrosis, the technology will also benefit other injectable products,     including: GAMMAGARD for Primary Immunodeficiency (PI) and Insulin for Diabetics, etc.   "
89694|NCT02112084|"     Individuals providing end-of-life caregiving to partners with terminal cancer often begin the     bereavement process before the patient dies and with additional sources of stress. We know     that grief for these partners can be long-term and impact virtually every aspect of their     lives. This project will test the effectiveness of a new promising intervention that uses a     dual process model (DPM) which focuses both on loss orientation (emotional loss and grief     (referred to as LO)) and restoration orientation (learning new tasks of living that may have     been the primary responsibility of the spouse who has died (referred to as RO tasks)).   "
89695|NCT02112071|"     The general objective is to investigate the effect of a 12 week walking exercise program on     vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers     in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).   "
89696|NCT02112058|"     The Supporting Healthy Marriage (SHM) evaluation was launched in 2003 to test the     effectiveness of a skills-based relationship education program designed to help low- and     modest-income married couples strengthen their relationships and to support more stable and     more nurturing home environments and more positive outcomes for parents and their children.     The evaluation was led by MDRC with Abt Associates and other partners, and it was sponsored     by the Administration for Children and Families, in the U.S. Department of Health and Human     Services.      SHM was a voluntary, year long, marriage education program for lower-income, married couples     who had children or were expecting a child. The program provided group workshops based on     structured curricula; supplemental activities to build on workshop themes; and family support     services to address participation barriers, connect families with other services, and     reinforce curricular themes. The study's random assignment design compared outcomes for     families who were offered SHM's services with outcomes for a similar group of families who     were not but could access other services in the community.   "
89697|NCT02112045|"     This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan     before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy     drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant.     Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may help multiple     myeloma cells move from the patient's bone marrow to the blood where they may be more     sensitive to treatment with melphalan. It is not yet known whether adding XMO2 Filgrastim     (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in     treating multiple myeloma   "
89698|NCT02112032|"     This study is to test how safe it is to give the combination of PEG IFN-α2b (SYLATRON) and     MK-3475, an investigational drug, to patients with advanced melanoma. Its effectiveness     against melanoma will also be evaluated.   "
89699|NCT02112019|"     Sjögren's syndrome (SS) is an autoimmune inflammatory disorder of the exocrine glands. It     particularly affects the lacrimal and salivary glands. Severe dry mouth and eyes are     frequently reported as presenting symptoms. These symptoms are in many cases accompanied by     nonspecific symptoms, such as malaise and fatigue. In addition, extraglandular     manifestations, like purpura, polyneuropathy, and arthritis, can be present. SS affects     mainly women with a female/male ratio of 9:1 and can occur at all ages. Due to the     irreversible damage to the saliva producing cells, the quantity and quality of saliva     reduces. The progressive nature of the syndrome results in a further reduction of salivary     flow. Due to hyposalivation the patients suffer from progressive dental decay, dental     erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste),     inflammation of the oral mucosa and lack of retention of removable dentures. Overall, this     can be qualified as a reduction in the quality of life. Until now no effective (palliative)     therapy to relieve dry mouth complaints is available. A recent case series study suggests     that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients     suffering from SS. In this technique the ducts of the salivary glands are rinsed with saline     and cortisone and possible strictures are dilated. It is hypothesised that performing a     sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and     improve the reported mouthfeel score.   "
89700|NCT02112006|"     The purpose of this study is to compare two different injection sites for local anesthesia in     patients having hand surgery. The hypothesis is that subjects receiving injections around the     three nerves of the forearm will provide faster pain control and greater patient satisfaction     than patients having one injection closer to the shoulder.   "
89701|NCT02111993|"     The objective of this study is to evaluate myocardial injury, if any, as quantified by     cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of     implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV)     method vs. standard defibrillation threshold method.   "
89735|NCT02111551|"     This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A     [3-(2,4-dimethoxybenzylidene) anabaseine] may have positive effects on mental focus and may     help us to find new types of treatment for autism spectrum disorder. Subjects will come in     for a screening visit and three more drug visits. There will be at least one week between     each drug visit to allow the drug to be eliminated from your system completely. During each     drug visit subjects will receive either a placebo (a capsule that looks like medicine but is     not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well     being will be monitored by the study physician. Subjects will complete some paper and pencil     tasks to test memory, attention, speed, and problem solving, some rating scales and     questionnaires, and the study team will record brain wave patterns with an     electroencephalogram (EEG) .   "
89702|NCT02111980|"     If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure,     it can cause a serious infection. To prevent this from happening, a new device has been     developed that uses radiofrequency (RF) signals to detect the presence of surgical sponges     inside the body. The device is now being used routinely to make sure that no sponges are left     inside a patient at the end of an operation. However, the RF device has not been implemented     in procedures for patients with cardiac implantable electronic devices (CIEDs). While the     device is FDA approved for use, there is a theoretical concern that the radiofrequency     signals used to detect the sponges will change the settings on the pacemaker or the     defibrillator. Changing the settings on a pacemaker might make it pace the heart too quickly     or too slowly, while changing the settings on a defibrillator might cause unnecessary shocks     or prevent it from shocking the heart if the patient were to have cardiac arrest.      The purpose of this study is to test whether the radiofrequency device used to detect sponges     can cause a clinically significant change to the settings on pacemakers and defibrillators.     To minimize potential risk, the device will be tested only on patients who are having the     pacemaker or defibrillator removed or replaced as part of their regular medical care, either     because it is infected or because the battery has worn out. Before the pacemaker or     defibrillator is removed, the settings will be carefully and completely recorded and the     radiofrequency device will be used to scan the body for sponges as it would be done during     normal operation.      After the pacemaker or defibrillator is taken out, the settings will again be recorded and     compared to the settings before the scan. In a standard device removal procedure, no     clinically significant change in CIED settings would be expected. If a new pacemaker or     defibrillator is implanted in the patient, it will not be exposed to the detection device at     all. We will also test whether the RF device has any effect on temporary pacemakers that     patients may receive after open heart surgery. We plan to perform testing in a total of 50     patients, 40 with permanent pacemakers or defibrillators and 10 with temporary pacemakers.   "
89703|NCT02111967|"     In this study we compare the vitamin B12 status by measuring serum vitamin B12 and     holotranscobalamin in type 2 diabetic patients with and without metformin treatment.     Afterwars we investigate which biomarker could be adequate to reflect B12 status in     metformin-treated patients.      With the help of a questionnaire we assess clinical, nutritional and demographic factors     which are associated with vitamin B12 deficiency.   "
89704|NCT02111954|"     Prostate cancer patients for whom a F-18-FCH PET/CT is indicated. Ga-68-NODAGA-MJ9 is a new     PET/CT radiotracer aiming at giving complementary information : more precise images and early     localisation of recurrence to standard imaging   "
89705|NCT02111941|"     This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in     treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary     peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's     peptide treated white blood cells may help the body build an effective immune response to     kill tumor cells.   "
89706|NCT02111928|"     This observational pilot-study is intended to collect outcome data from a cohort of 30     patients suffering from hyper-evaporative dry eye disease who are treated with the medical     device NovaTears® eye drops for a duration of 5 to 7 weeks.   "
89707|NCT02111915|"     The rates of perinatal depression in South Asian women are reported to be amongst the highest     in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In addition to     its profound impact on women's health, disability and functioning, perinatal depression is     associated with poor child health outcomes such as pre-term birth, infant under-nutrition and     stunting. There is robust evidence that perinatal depression can be effectively managed with     psychological treatments delivered by non-specialist health care workers. Our previous     research conducted in Pakistan led to the development of the Thinking Healthy Program (THP).     THP is a psychological treatment delivered by community health workers (CHWs) which more than     halved the rate of perinatal depression among mothers and led to significant improvements in     child health outcomes. To enhance access to such evidence-based psychological treatments,     there is a need to examine the potential role of other human resources such as lay persons in     delivering psychological treatments such as THP in poor resource settings.   "
89708|NCT02111902|"     The availability of data on plasma 25-Hydroxyvitamin D (25(OH)D) concentrations in the last     two rounds of the National Health and Nutrition Examination Survey (NHANES) has generated a     high level of interest in the consequences of 25(OH)D deficiency and in particular its     potential impact on black Americans. Fundamental new questions about the biology of vitamin D     have now come to the fore. Are low 25(OH)D-intact parathyroid hormone (iPTH) levels a     physiologic abnormality in African Americans or does the 25(OH)D-iPTH system have     sufficient plasticity to adapt to low sunlight exposure? Could the low 25(OH)D levels which     result from the gene- environment discordance observed in dark skinned populations in the     US be a risk factor for metabolic disorders? Ultimately, the public health community and     regulatory bodies must offer recommendations for optimal levels and supplementation. The     investigators propose to utilize cohorts from an ongoing NIH-funded study designed to     identify determinants of weight change and cardiovascular disease risk in five Afro-origin     populations [Modeling the Epidemiologic Transition Study (METS)] to examine these questions.     The five METS countries include Ghana, Seychelles, South Africa, Jamaica and the US; the five     populations differ greatly in terms of sun exposure and dietary intakes. In addition to the     extensive energy expenditure, dietary intake and obesity-related metabolic markers being     measured in METS, the investigators propose to assess plasma 25(OH)D, iPTH, serum and urinary     calcium, plasma markers of bone resorption and formation, and quantitative ultrasound of the     calcaneus. The associations of adiposity, weight change, cardiovascular disease (CVD) risk     factors such as blood pressure and insulin, and bone strength with 25(OH)D and iPTH will be     assessed. The proposed study will provide a comprehensive assessment of the distribution and     determinants of 25(OH)D-iPTH and related physiologic measures across a wide range of latitude     and lifestyles. These data should contribute substantially to the understanding of the     normal range within which these hormones function and their significance in Afro- origin     populations.   "
89709|NCT02111889|"     The investigators hypothesize that response to kinase inhibitors is dependent on achieving     pharmacological active drug levels in tumor tissue and that quantitative PET imaging can     predict kinase inhibitors tumor concentrations. The ultimate aim is to develop a quantitative     PET based imaging tool to differentiate between patients who will respond to therapy with     kinase inhibitors.      The main objective of this study is to determine whether tumor concentrations of kinase     inhibitors at pharmacological active doses can be predicted from PET studies using tracer     amounts (microdosing) of corresponding radiolabeled kinase inhibitors. This objective     includes the development and validation of pharmacokinetic models for radiolabeled kinase     inhibitors as well as validation of the microdosing concept for kinase inhibitors.   "
89710|NCT02111876|"     There is currently no good description of patients surviving an episode of acute hypercapnic     respiratory failure in the ICU. For instance, the prevalence of OSA and sleep hypoventilation     in a stable clinical condition is not known in this population.      This prospective cohort describes the clinical profile, predictors of readmission (followed     over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a     stable clinical condition 3 months after ICU discharge) in patients treated for an episode of     acute hypercapnic respiratory failure in the ICU.   "
89770|NCT02111083|"     The study involves 4 injections of insulin lispro and its purpose is to:        -  Determine if 2 formulations of insulin lispro are treated by the body in a similar way.        -  Compare how the 2 formulations of insulin lispro affect blood sugar level.        -  Determine the safety of each insulin lispro formulations and any side effects that might          be associated with them when given to healthy participants. The study is expected to          last up to approximately 9 weeks for each participant.   "
89711|NCT02111863|"     Background:      The NCI Surgery Branch has developed an experimental therapy that involves taking white blood     cells from patients' tumors, growing them in the laboratory in large numbers, and then giving     the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL     and we have given this type of treatment to over 100 patients. In this study, we are     selecting a specific subset of white blood cells from the tumor that we think are the most     effective in fighting tumors and will use only these cells in making the tumor fighting     cells.      Objective:      The purpose of this study is to see if these specifically selected tumor fighting cells can     cause melanoma tumors to shrink and to see if this treatment is safe.      Eligibility:      - Adults age 18-70 with metastatic melanoma who have a tumor that can be safely removed.      Design:        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as          needed        -  Surgery: If the patients meet all of the requirements for the study they will undergo          surgery to remove a tumor that can be used to grow the TIL product.        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood          cells. {Leukapheresis is a common procedure, which removes only the white blood cells          from the patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the          hospital for about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits take up to 2 days.   "
89712|NCT02111850|"     Background:      The NCI Surgery Branch has developed an experimental therapy for treating patients with     metastatic cancer that involves taking white blood cells from the patient, growing them in     the laboratory in large numbers, genetically modifying these specific cells with a type of     virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the     patient. This type of therapy is called gene transfer. In this protocol, we are modifying the     patient s white blood cells with a retrovirus that has the gene for anti-MAGE-A3-DP0401/0402     incorporated in the retrovirus.      Objective:      The purpose of this study is to determine a safe number of these cells to infuse and to see     if these particular tumor-fighting cells (anti-MAGE-A3-DP0401/0402 cells) cause tumors to     shrink and to be certain the treatment is safe.      Eligibility:      - Adults age 18-70 with metastatic cancer expressing the MAGE-A3 molecule.      Design:        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as          needed        -  Leukapheresis: If the patients meet all of the requirements for the study they will          undergo leukapheresis to obtain white blood cells to make the anti-MAGE-A3-DP0401/0402          cells. {Leukapheresis is a common procedure, which removes only the white blood cells          from the patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the anti-MAGE-A3-DP0401/0402 cells and aldesleukin.          They will stay in the hospital for approximately 4 weeks for the treatment.        -  Follow up: Patients will return to the clinic for a physical exam, review of side          effects, lab tests, and scans about every 1-3 months for the first year, and then every          6 months to 1 year as long as their tumors are shrinking.   "
89713|NCT02111837|"     This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month     pilot safety study to evaluate the effects of specific lipid fractions-enriched infant     formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth     of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to     growth of infants fed standard infant formula.   "
89714|NCT02111824|"     The goal of this clinical research study is to test the use of a minimally invasive     multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy. The     safety of the MIMIG intervention system will also be studied.   "
89715|NCT02111811|"     The purpose of this research study is to test the effectiveness of a new telephone counseling     program for employed Veterans with depression called the Veterans Work and Health Initiative     (V-WHI). 250 participants will be recruited and randomly assigned to one of two groups: the     V-WHI experimental group or usual mental health care. The V-WHI counselors will address     mental health and job-related issues that interfere with working. This counseling is provided     solely over the phone with sessions every 2 weeks for 4 months (eight sessions total). At 8     months post-baseline, the V-WHI group is provided with a booster session. Participants in     both groups are administered follow-up questionnaires at two time-points: month five and     month nine.   "
89716|NCT02111798|"     This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day     on initiation and maintenance of cocaine abstinence in a population of cocaine dependent     methadone maintenance patients (N = 200) who can earn financial incentives for stopping their     cocaine use. Bupropion is a promising medication for this purpose because of its previously     demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems.     The study will use a stratified randomization strategy that will allow us to separately     examine bupropion effects on abstinence initiation and relapse prevention. Outcomes will be     tracked over a 6-month time frame that includes assessment of drug use during and after     incentives have stopped. In addition, the project will provide novel information about     mechanisms of medication effects by measuring subjective drug effects, drug vs money choices,     and self-reports of pleasure derived from daily non-drug activities. The investigators     hypothesis is that bupropion as compared to placebo treatment will both enhance rates of     abstinence initiation in those who have difficulty stopping cocaine and retard rates of     relapse in those who initially stopped their cocaine use. Furthermore that bupropion compared     to placebo participants will report non-drug activities as more pleasurable (reinforcing),     will engage in more of them. If hypothesized synergies are demonstrated, the study will point     the way to a significant advance in improved treatment strategies for this critical group of     drug abusers.   "
89717|NCT02111785|"     Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small     blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms     including headache, confusion, limb weakness, and difficulty speaking.      There is currently no agreement among physicians as to the best way to treat this condition.     One option is to do a surgery to drain the blood that has collected. Usually the surgery     involves drilling small holes in the skull to relieve pressure and allow blood and fluids to     be drained. Another option is to give medications such as steroids that might reduce the     swelling. However, no drugs have been approved by the Food and Drug Administration (FDA)     specifically to treat this condition. Some patients elect to have no treatment.      The purpose of this study is to investigate whether investigational treatment with a 2 week     course of oral dexamethasone is as effective as surgery for cSDH. The study hypothesis to be     tested is: For patients with unilateral, symptomatic chronic subdural hematoma, there is no     difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2     at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with     those treated with burr hole surgical drainage.   "
89771|NCT02111070|"     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated     Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single     intramuscular injection   "
90128|NCT02106351|"     The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport     used in the treatment of upper limb spasticity (altered skeletal muscle performance) in     children with cerebral palsy (CP).   "
89718|NCT02111772|"     In patients with asthma, reactions to allergens in the environment (such as mold, pollen,     weed, domestic pets, and dust allergens) play an important role in causing asthma symptoms.     However, upper respiratory tract infections, typically those caused by the common cold virus,     rhinovirus, can also cause asthma to get worse. In previous studies at the University of     Virginia, it was found that mild asthmatics, who had high levels of the allergy antibody     (called IgE) in their blood, developed more persistent cold and chest symptoms when they were     given an infection with rhinovirus (the most frequent cause of the common cold). The cold     symptoms produced by rhinovirus tend to peak during the first 4 -7 days of the cold. These     symptoms, including nasal congestion, are similar to what you have experienced with previous     colds.      This study is being done to learn how a common cold caused by a viral infection affects     people with asthma. The goal is to learn how to improve the care of asthma symptoms caused by     the common cold virus (called rhinovirus). Most adults experience one or two colds caused by     rhinovirus every year. In addition, 75-80% of asthma exacerbations caused by viral infections     are caused by this virus, primarily in children. Adults are less likely to experience     significant changes in their asthma symptoms when they get colds, because they have developed     protective immune responses from previous colds which help diminish symptoms.   "
89719|NCT02111759|"     The purpose of this study is to conduct a randomized controlled trial to determine if the     knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft     fixation has an effect on postoperative outcomes. The specific research questions are: what     is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3)     antero-posterior (AP) knee stability; 4) rate of re-operation.   "
89720|NCT02111746|"     The purpose of this study is to assess the efficacy of the intraoperative injection of     prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical     incisions.   "
89721|NCT02111733|"     Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal     failure patient at Sherbrooke University Hospital Center as determined by serial     measurements. Verification of potential effects of these levels and their variation as     predictors of cardiovascular outcomes and events at 6 and 12 months.   "
89722|NCT02111720|"     The decision to disclose one's serostatus to family members creates considerable emotional     strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While     disclosure to family members has been linked to positive outcomes including increased social     support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and     stress, and improved HIV disease management, the decision not to disclose can also lead to     positive outcomes. To date, most research about serostatus disclosure has focused on the act     of disclosing - the who, what, where, and when of disclosing - rather than the decision     process involved. The investigator's long-range goal is to further refine and evaluate an     intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this     goal, the investigators are proposing a course of study with the following specific aims:     Specific Aim 1. Assess the effectiveness of the intervention relative to an attention-control     condition on a variety of primary outcomes related to disclosure and health. Specific Aim 2:     Examine the effects of the intervention over time. Specific Aim 3: Explore the potential     mediating effects of disclosure decision making on the primary outcomes. Specific Aim 4:     Explore potential moderating effects of participant demographics (e.g., gender, age),     relationship characteristics (i.e., relationship satisfaction, proximity, importance of     disclosure), and contextual variables related to family (e.g., adaptability, problem-solving)     on intervention effectiveness. Specific Aim 5: Evaluate the effects of treatment engagement,     retention and expectations on outcomes.   "
89723|NCT02111707|"     To determine if the timing of administration of indomethacin affects the primary outcome of     post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive     pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.   "
89724|NCT02111694|"     The objective of the proposed research is to conduct a within-subject, experimental study     that will describe mothers' feeding practices during typical bottle-feeding conditions and     will examine whether removal of visual cues related to the amount of milk/formula in the     bottle will alter these feeding practices. The investigators hypothesize that mothers will     show higher levels of infant-directed feeding practices and lower levels of mother-directed     feeding practices when using opaque, weighted bottles compared to when using standard, clear     bottles. The investigators also hypothesize that infants will consume less breast milk or     formula when fed from opaque, weighted bottles compared to when fed from standard, clear     bottles.   "
89725|NCT02111681|"     The purpose of this study is to test the use of Calypso beacon implants as a way to determine     where the lung tumor is located during radiation treatment. The Calypso beacons are small     devices that are implanted in the lungs, near the tumor. They are able to send a signal to a     tracking system to show where they are, and where the tumor is, as the patient holds their     breath for the radiation treatment. The investigators want to find out what effects, good     and/or bad, that this has on the patient and the way they treat the cancer in your lungs.   "
89726|NCT02111668|"     Aortic dilatation syndromes are comprised by a group of different syndromes, of which Marfan     syndrome is the best described. Many of the aorta dilatation associated syndromes are     heritable connective tissue disorders but some patients do not have any other phenotypical     symptoms than aorta dilatation. The genetic variation in thoracic aorta dilatation is still     unknown. This study aims on genetic evaluation of patients with thoracic aorta dilatation.     Furthermore the study will focus on a registry angel trying to evaluate prevalence,     mortality, morbidity and socioeconomically status of Marfan syndrome patients. This part will     rely on registry data obtained from unique Danish registries.   "
89798|NCT02110719|"     In recent years, there has been an emphasis on the creation of enhanced-recovery,     fast-track or multi-modal pathways to improve perioperative care (1-4). The goal of these     programs is to reduce the length of hospital stay, decrease narcotic usage while improving     pain control, accelerate post-operative recovery, and expedite return to baseline functional     status. Pathways often are developed by a team of surgeons, nurses, pain specialists,     anesthesiologists and other support staff. Postoperative components often involve multi-modal     analgesia, early return to activity and early return to a regular diet. The goal of this     study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery     with a primary goal of decreasing narcotic usage.   "
89727|NCT02111655|"     All vascular access guidelines recommend monitoring and surveillance protocols to prevent     vascular access complications in hemodialysis units.      However, in the case of second generation screening techniques which determine access blood     flow measurement (QA), there is a huge controversy about it´s efficiency.      Although multiple observational studies find a decrease in the thrombosis rate and an     increased primary assisted patency survival related to the use of these techniques, a     recently published meta-analysis find contradictory results in the randomized controlled     trials, affirming that the measurement of QA is useless in grafts and questionable in native     arteriovenous fistulae (AVF).      We have designed a multicenter, prospective, open label, controlled, randomized trial, to     prove the usefulness of the QA measurement using two complementary second generation     techniques, Doppler ultrasound and Transonic dilution method, compared to the classical     monitoring and surveillance methods.      The primary endpoint will be a reduction in the thrombosis rate with an increased assisted     primary patency survival, and a cost effectiveness economic analysis.      As secondary endpoints we will analyze the impact over non-assisted primary patency survival     and secondary patency survival.   "
89728|NCT02111642|"     Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or     cervix, bowel, bladder, or rectum. Although options for treatment include expectant     management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is     the only option which potentially offers a cure.      It is well known that women with pelvic organ prolapse are at risk of developing new stress     urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined     as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing,     coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic     anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of     such a procedure is a mesh sling placed underneath the urethra (midurethral sling).     Nevertheless, the decision to place a midurethral sling to prevent stress urinary     incontinence after prolapse surgery remains controversial.      A new risk calculator tool has been developed to provide patients' with their individualized     risk of developing de novo stress urinary incontinence after prolapse surgery. The primary     objective of this study is to determine whether use of this new personalized online risk     calculator tool increases patient satisfaction with the decision whether or not to have a     midurethral sling placed at the time of prolapse surgery to prevent development of stress     urinary incontinence. The investigators hypothesize that use of this tool will increase     patient satisfaction with their decision regarding midurethral sling placement.   "
89729|NCT02111629|"     Genital tract infections (GTIs) have increased in the past decade and there is an association     between sexually transmitted infections (STIs) and other infections like bacterial vaginosis     (BV), with the HIV transmission. BV and Candida are the most common causes of vaginal     infections in symptomatic women, the prevalence of BV being 22-50% and the prevalence of     Candida 17-39%. In an effort to reduce the transmission of GTIs, the World Health     Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative in     places with no access to laboratory diagnostic tests.      Justification. In patients with syndrome of vaginal discharge, an effective treatment against     Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced, therefore, for     syndromic management of symptomatic vaginal discharge the combination of fluconazole and     secnidazole could be used. No studies evaluating this combination were found in the     literature reviewed.      Objectives: To describe the safety and the clinical and microbiological efficacy of a single     oral dose of a combined treatment with secnidazole + fluconazole for the syndromic management     of symptomatic vaginal discharge.      Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and     safety of the combination of fluconazole and secnidazole for the treatment of symptomatic     vaginal discharge. The participants will be sexually active women with lower genital tract     symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral     symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be conducted     in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive character     of the study, no a priori hypothesis is considered. A consecutive convenience sample size of     100 symptomatic patients is calculated. The statistical analysis will be performed with STATA     11.0 software (College Station, Texas, USA). Simple and relative frequencies and measures of     central tendency and dispersion appropriate for the distribution of the variables will be     calculated. The study has been submitted and approved by the Ethics Committee of the Faculty     of Medicine of the National University of Colombia and the Institutional Review Board of the     participating institution. All women must sign a written informed consent form agreeing to     voluntarily participate in the study.   "
89730|NCT02111616|"     Purpose: Cancer survivorship is a high clinical and research priority both nationally and at     the University of North Carolina. The investigators propose a randomized pilot study testing     the development, implementation and evaluation of a parallel patient and streamlined provider     version of a personalized Survivorship Care Plan (SCP) with lung cancer patients.      Participants: 60 lung cancer patients at Rex Cancer Center.      Procedures (methods): Participants will be recruited and randomized to the standard of care     (30 patients) or intervention (30 patients) arm. Patients randomized to standard of care will     receive a tailored survivorship care plan at the end of cancer treatment. Patients randomized     to the intervention will receive a care plan and coordinating visit with their primary care     provider. Patients will be invited to complete baseline and follow-up assessments regarding     care needs and confidence in post cancer care.      All patient primary care providers will receive condensed provider versions of the care plan.     Providers will be asked to evaluate how the SCP and coordinated care visit (intervention     only) facilitated communication and coordination of care.   "
89731|NCT02111603|"     The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid     excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of     increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability     of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with     Colesevelam.   "
89732|NCT02111590|"     The aim of this study is to evaluate development of hemolysis and the variation in isokinetic     muscle strength in two groups of patients with chronic inflammatory demyelinating     polyneuropathy (CIDP) or multifocal motor neuropathy (MMN)        1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG) to          weekly treatment with subcutanoeus immunoglobulin (SCIG)        2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®.      Hypotheses        -  During treatment with IVIG blood hemoglobin will fluctuate with a decline due to          infusion, whereas it will remain stable during SCIG treatment without fluctuation        -  Isokinetic muscle strength in affected muscle groups is more stable during treatment          with SCIG than with IVIG        -  Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or          Hizentra® and Gammanorm® treatment   "
89733|NCT02111577|"     The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care     Chemotherapy can improve survival times for patients with Metastatic Castration Resistant     Prostate Cancer.   "
89736|NCT02111538|"     Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin     light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the     prognosis predominantly depend on the presence and severity of cardiac involvement, it was     shown that malnutrition is an independent predictor of survival and quality of life. However,     the assessment of nutritional status by common indices based on anthropometry is not always     feasible and accurate due to reduced performance status and/or the presence of fluid     imbalances (for example edema and ascites). Several recent studies have demonstrated the     prognostic value of the phase angle. Moreover, the value is supported by its applicability to     patients who are bedridden or present alterations in the state of hydration.   "
89737|NCT02111525|"     The purpose of this study is to determine the distribution of lung fluid status as reported     by the IMED-4 system in patients presenting to the emergency department or urgent care     facility with shortness of breath.   "
89738|NCT02111512|"     Egg allergy is common in early childhood, affecting at least one in 50 preschool children.     Influenza ('flu) vaccines contain egg protein, as the vaccine is cultured in hen's eggs.     There is robust data to support the safety of influenza vaccines (containing low or     negligible amounts of egg protein) in patients with egg allergy.      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been     approved by a number of licensing boards and is given by a spray into the nose. This new     vaccine has been available in the United States for several years and is highly effective and     against influenza infection, with an excellent safety profile in children without egg     allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO     published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses     were given to 282 egg-allergic children; data is currently being analysed.      The objective of this multicentre study is to further assess the safety of intranasal LAIV in     egg-allergic children, in order to demonstrate that these children can safely be given the     new LAIV within a primary care health environment.   "
89739|NCT02111499|"     Clinical investigation of anti-psoriatic efficacy and atrophy   "
89740|NCT02111486|"     This clinical trial is being conducted to study whether eating certain meals will reduce your     desire to eat and for a longer period of time compared to others and to determine the     post-meal glucose response associated with each of these breakfast foods.   "
89741|NCT02111473|"     The study is designed to answer the following questions:      1) What is the effect of testosteron replacement treatment on the endothelial dysfunction.      2/ What is the effect of testosteron replacement on the bone mineral metabolism.   "
89742|NCT02111460|"     This is a randomized parallel control trial to evaluate whether radical loco-regional     Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal     carcinoma.   "
89743|NCT02111447|"     Children who receive general anesthesia may become agitated (emergence delirium) in the     recovery period. This occurs more often after inhalational anesthetics, particularly     sevoflurane and desflurane than after propofol. However, agitation after anesthesia in     children may be difficult to distinguish from pain; accordingly studies are ideally designed     during MRI to obviate the contribution of pain during emergence. Airway complications have     been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs.     Whether the airway complications were due to the LMA or the isoflurane was unclear.     Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane     compared with IV propofol and 2. airway complications after LMA or nasal prongs.   "
89744|NCT02111434|"     The study is designed to answer the following questions:        1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio          in hypogonadism?        2. What is the effect of testosterone replacement on the visceral adiposity index and          Triglycerides/HDL cholesterol ratio?   "
89745|NCT02111421|"     Currently, spinal anesthesia is most commonly used for cesarean section.But spinal anesthesia     can not block the visceral vagus nerve, and the patients are prone to nausea, vomiting, chest     tightness or other discomfort when the uterus is stretched .For parturients who have poor     uterine contractions and are bleeding larger, obstetricians often use oxytocin to strengthen     the contraction of the uterine,which also would increase the parturients'     discomfort.Anesthesiologists often intravenous sedative hypnotics (eg.propofol or midazolam)     to alleviate the fear of the parturients after the baby is delivered.One of the side effects     of propofol or midazolam is that they would lead to the respiratory depression.For the poor     respiratory reserve of the parturients, functional residual capacity(FRC) of this group could     be reduced by up to 20%, and the oxygen consumption was also increased.The SPO2 could decline     quickly intraoperatively.Dexmedetomidine is a novel , highly selective α2 adrenergic receptor     agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could     provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic     nerves and other effects.Because of its minimal impact on the respiratory , it could safely     and effectively used to sedate patients undergoing cesarean section.But the change of     endocrine system and hemodynamic of the parturients may affect the pharmacokinetics and     pharmacodynamics of some anesthetic drugs.Currently studies have demonstrated the increased     sensitivity of some anesthetic drug in parturients, such as lidocaine and isoflurane.The     study is aim to explore the optimal dexmedetomidine dose to produce suitable sedation in     parturients ,and compared with norman nonpregnant women.   "
89746|NCT02111408|"     The purpose of this study is to investigate sleep disordered breathing, autonomic     dysfunction, and post stroke depression in acute and chronic stroke patients. Furthermore, to     explore the interaction between these comorbidities, and their relation to stroke aetiology.   "
89785|NCT02110888|"     Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant     proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of     low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity mark     for the treatment of chronic refractory neuropathic pain and is now commonly used in some     countries to target back pain. However, the potential value of combining SCS and PNS as     hybrid stimulation remains poorly described with only isolated case reports or limited     experience in various indications.      The CUMPNS comparative randomized study is designed to demonstrate the potential analgesic     efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain     component pain in refractory FBSS patients.   "
89747|NCT02111382|"     Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue     mobility/ motility dysfunctions in general, using different approaches (depending on the     target tissue) known as osteopathic manipulative treatment.      Among all the available techniques those ones addressed to the cranial field are most     questioned because of the lack of scientific evidence; but the compression of the 4th     ventricle technique has been largely studied in clinical trials. Studies have shown that the     technique may affect both central and autonomous nervous system, modulating some reflexes     (Traube-Hering baro signal), and modifying brain cortex electrical activity through central     sensitization in subjects with chronic low back pain.      Thus, investigators hypothesize that the compression of the 4th ventricle may modulate peak     alpha frequency (electroencephalographic assessment) and promote physical relaxation in     subjects in vigil.   "
89748|NCT02111369|"     Essential tremor is the most common adult-onset movement disorder, and essential voice tremor     is the vocal manifestation of essential tremor. While nearly all essential tremor patients     experience hand tremor, many also manifest head tremor and voice tremor. Essential voice     tremor can lead to increased vocal effort, decreased intelligibility, and misconstrued     emotional state. Only one medication, propranolol, is FDA-approved to treat essential tremor.     Propranolol is not felt to be nearly as effective for axial tremors (head, trunk, neck) as it     is for extremity tremors. However, this has not been studied with any objective assessment in     a prospective way for EVT. For patients with essential voice tremor, the limited published     data suggests that botulinum toxin has been shown to lead to functional voice improvement.     Botulinum toxin, though also not well-studied with objective voice outcomes, is a commonly     used clinical therapy for treatment of essential voice tremor. While it is used more often     for essential voice tremor than propranolol therapy, botulinum toxin also has not been     prospectively studied with validated, objective voice outcome measures. The investigators     would like to determine if propranolol has any significant effect on vocal tremor. The     investigators would also like to determine, in an objective way, the effect of botulinum     toxin on vocal tremor. If effective, propranolol would provide an affordable and non-invasive     alternative or addition to botulinum toxin injections for patients with essential voice     tremor.   "
89749|NCT02111356|"     Pinhole glasses which is using pinhole effect may induce a functional change on the eyes,     including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude,     CS, Visual field(VF), Stereopsis.   "
89750|NCT02111343|"     The current study aimed to examine the effectiveness of a Computer-based auditory training     (CBAT) intervention for children with Central Auditory Processing Disorder (CAPD) by     comparing the changes in auditory processing (AP) and functional listening skills of these     children immediately post-intervention, to that of the untrained controls. The AP skills of     the trained group were evaluated again at 3 months post-intervention to examine the     sustainability of any improvements made from the CBAT intervention. I hypothesised that after     intervention, children from the auditory training (AT) group would improve in their AP     skills, and that improvement would be greater than the changes in AP skills of those     untrained controls. I also hypothesised that the improvement made from the intervention would     sustain for at least 3 months after the end of intervention. Finally, I examined if the     training outcomes are predictable from any underlying factors such as the initial AP,     language, or cognitive skills of these children.   "
89751|NCT02111330|"     Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240     mg) after repeated (8 days) single daily oral dose administration in young male and female     healthy subjects.   "
89752|NCT02111317|"     The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp)     inhibitor, on the pharmacokinetics of ASP015K. This study will also assess the safety and     tolerability of ASP015K administered alone and also and in combination with verapamil.   "
89753|NCT02111304|"     The primary hypothesis is that administration of iOWH032 to adult and pediatric males and     females with acute cholera due to V. cholerae O1 reduces stool output in the first 24 hours     significantly more than does the current standard of care.   "
89754|NCT02111291|"     The current trial examines the potential benefits of continuous 12 week treatment with     Santyl, measured in terms of wound bed appearance. The visual appearance of granulation     tissue will be recorded at each visit for the purpose of examining the relationship between     wound bed appearance and progress towards healing. In support of this longer treatment     regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was     safe and well tolerated. Therefore, the present study is designed to test the hypothesis that     daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in     more rapid development of granulation tissue than DFU treated with supportive care.   "
89755|NCT02111278|"     The purpose of this study is to determine if the addition of lumbar manipulation will improve     function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim     of this study is to determine if a modification of a clinical prediction rule by Flynn will     be effective in identifying adolescent patients with low back pain who would benefit from     lumbar manipulation.   "
89756|NCT02111265|"     Compare the efficacy and safety of closed-loop target controlled infusion of propofol or     etomidate at general anesthesia in geriatric patients   "
89757|NCT02111252|"     This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in     healthy Japanese adult participants   "
89758|NCT02111239|"     The purpose of this study is to determine whether preoperative abdominal imaging using either     CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and     patient outcomes in DIEP flap breast reconstruction.   "
89786|NCT02110875|"     The purpose of this study is to learn more about balance and strength in an elderly     population (60 and older). Data will be compared between controls and the age/gender- matched     PD participants in study The Effects of vitamin D on Balance in Parkinson's disease (OHSU     IRB # 6482). Specifically a t-test will be used to compare total work and total power on leg     extension and flexion, composite SOT score conditions 1-3 and 4-6, response strength and     latency on MCT, and turn duration from the iMOBILITY between the two groups.   "
89787|NCT02110862|"     The aim of this study is to evaluate scintigraphic methods as objective factors for     functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The     gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the     functional outcome.   "
89759|NCT02111226|"     Heart disease and stroke are the number one killers world-wide. When someone has     hypertension, the constantly elevated blood pressure damages their blood vessels and the     organs that they supply blood to. This causes stroke, heart attack, heart failure, kidney     failure and dementia. Finding and lowering high blood pressure to normal with lifestyle     changes and if necessary medications, lowers the risk of these outcomes. Canada has high     rates of blood pressure control compared to other countries in the world, due in large part     to the successful dissemination of hypertension guidelines. However remote and disadvantaged     communities have not been as successful and need additional measures to help achieve the same     level of blood pressure control as the rest of the country. The DREAM-GLOBAL team has     extensive experience working with Canada's Aboriginal Communities and a large community in     Tanzania. The DREAM-GLOBAL project will integrate innovations in technology with the     implementation of guidelines-based blood pressure control and through partnerships with     experts in government and industry, overcome barriers to lowering blood pressure in Canada's     Aboriginal Communities, and in a community in Tanzania. Tools will be developed and tested     that will close the circle of care around people with hypertension by bringing measurement     data to the medical record and health care provider and also sending useful medical feedback     to the person with hypertension via secure data servers and routine SMS messaging on cell     phones. The system will be tested for effectiveness of diagnosing and also for managing     hypertension. To begin the process of preventing hypertension, the team will also explore     with an Aboriginal community how to create policies to reduce the sodium content in their     food. If proven effective, DREAM-GLOBAL can also become a platform for managing other chronic     diseases.   "
89760|NCT02111213|"     The primary aim of this research study is to evaluate the effectiveness of a computer-based     'virtual lay advisor' intervention relative to a proven human lay advisor/promotore     intervention to promote regular walking among inactive midlife and older Latino adults. The     primary analysis is a non-inferiority analysis comparing these two interventions.   "
89761|NCT02111200|"     The investigators will study and compare how effectively sodium phenylbutyrate, sodium     benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject     participation will require three, separate, four-day study periods at least one week apart.     During one study period (also called a treatment arm), subjects will take sodium     phenylbutyrate; during another they will take sodium benzoate; during another they will take     a combination of the two medications.      We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or     a combination of the two.   "
89762|NCT02111187|"     This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label     prospective clinical trial in men with localized high-risk prostate cancer undergoing radical     prostatectomy.      The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue     from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy     specimens to tumor tissue harvested at the time of prostatectomy.   "
89763|NCT02111174|"     The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will     relieve chemotherapy induced peripheral neuropathy (CIPN).      Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin     electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy machine     directs electrical signals across the field to simulate non-pain information.      Based on other studies, we think that we relieve pain with the Scrambler therapy device, but     it has not been tested in a setting such as this one. This means that some of the pain relief     could be due to placebo effect, or the CIPN pain going away on its own. In this study we want     to compare the Scrambler Therapy with the sham therapy (the therapy that does not use the     electrical signals). We hope that this study will help us determine if the Scrambler device     really helps patients with CIPN.      Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for at     least 3 months may be eligible to join this study.   "
89764|NCT02111161|"     The purpose of this study is to estimate the effect of intravenous polyspecific     immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome     measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft     tissue infections (NSTI).   "
89765|NCT02111148|"     The investigators assess in this study the sensitivity of Urea and Creatinine and that of     Nitrazine test in vaginal wash after injecting saline in the vagina of patients with     pre-labour rupture of membranes   "
89766|NCT02111135|"     Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and     impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus     type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus     vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus     vaccine (b-OPV) to infants early in life   "
89767|NCT02111122|"     Sleep wake disturbance is a common problem in Parkinson`s disease patients and so far the     therapeutic possibilities for symptomatic relief are limited. Small, open-label studies     indicate that the use of Xyrem (gamma-hydroxybutyrate) might be of benefit in this situation.      This study is intended to show a beneficial effect of the study medication in a randomized     cross-over trial, that fulfills strict scientific criteria.   "
89768|NCT02111109|"     Haemorrhage following major trauma is an important preventable cause of death. Those patients     who survive may have a prolonged period of debility caused by failure of key body organs. We     suspect that an important contributor to this organ failure may be dysfunction in the network     of small blood vessels that supply the bodies organs with oxygen and nutrients. Our study     will examine the link between the microcirculation and organ failure in patients who have     suffered significant bleeding after traumatic injury. We will also explore the relationship     between resuscitation of the global circulation (blood pressure, cardiac output etc.)an area     that is monitored in clinical practice with the state of the microcirculation, which by     contrast is not monitored. Patients with severe traumatic injury commonly have problems with     blood clotting. Some researchers have suggested that microcirculatory failure may be an     important contributor to this problem and we will explore this in more detail. Finally, we     will attempt to examine some of the mechanisms by which the microcirculation may be disrupted     by trauma and subsequent bleeding. These may include inappropriate activation of white blood     cells, inadequate function of oxygen carrying red blood cells and changes to the cells lining     the small blood vessels.      We will use a non invasive method to assess the microcirculation termed Side Stream Dark     Field microscopy. This involves recorded a video image of the movement of blood within the     small blood vessels under a patients tongue. In addition we will use ultrasound to assess the     flow of blood from the heart. Small samples of blood will be taken to assess blood clotting     and to look at possible mechanisms of microcirculatory dysfunction.      We aim to study ten patients in the first instance. The study will be carried out within the     intensive care units at Kings College Hospital.   "
89769|NCT02111096|"     The intent of this study is to assess the safety of LY2409021 in participants with Type 2     diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal     physician. The study treatment is expected to last 12 months (52 weeks).   "
89788|NCT02110849|"     To prospectively collect data from patients treated with proton therapy for prostate cancer     using the IUHPTC technique for the evaluation of toxicity and efficacy of this treatment     technique.   "
89799|NCT02110706|"     The specific primary objective of this study is to determine whether rituximab is a safe and     beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III     efficacy trial.   "
89772|NCT02111057|"     Researchers at the Hospital for Special Surgery are trying to learn more about post-operative     rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint     replacement surgery and what the result of flaring is for patients over the next year. We     will ask patients about their RA, whether it has gotten worse, and whether they are able to     work with the physical therapist. During the course of this study, we'll be collecting     questionnaires, and we'll be drawing blood to better understand what's going on with RA and     with a patient's recuperation from their joint replacement.      We want to understand whether a flare of RA might affect the outcome of a patient's joint     replacement. We believe this study might show us how to better manage patients with     rheumatoid arthritis following a joint replacement. If RA patients who flare are unable to     participate in physical therapy and do worse after one year after a total hip replacement,     more effective treatment could be developed. The study will also help us to identify early     factors that may influence long-term outcomes of joint replacements in RA patients.   "
89773|NCT02111044|"     The purpose of this study is to investigate in acromegalic patients the effect of different     doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability of     three different doses of ITF2984.   "
89774|NCT02111031|"     The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH®     CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United     States. The objective of the present registry is to demonstrate the impact on patient     management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients. Hereto the     hypothesis that the availability of CTC information provides clinicians important, timely     information and impacts treatment decisions, will be tested.      This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US,     and is being used in accordance with its labeling.   "
89775|NCT02111018|"     Prospective, randomized non-blinded, controlled study to assess the feasibility of the     CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring     renal replacement therapy.   "
89776|NCT02111005|"     Apoptosis is an evolutionary form of physiological cell death. Studies suggest that apoptosis     is involved in the pathogenesis of periodontal diseases. Human gingival fibroblasts (HGF)     have an important role in the periodontal immune response. It is believed that HGF can be     diminished and/or eliminated by means of apoptosis.      Smoking is one of the most common risk factor of periodontal disease. Studies indicated that     smoking can increase the risk of periodontitis by enhancing the apoptosis of gingival     fibroblast.      The purpose of this study is to determine and to investigate apoptosis of HGF in gingival     biopsies collected from smokers and non smokers who are diagnosed with chronic periodontitis     or aggressive periodontitis.      Eighty subjects will be invited to participate in this study. Patients will be allocated into     four groups (20 patients each). Gingival biopsies will be obtained from the base of papillae     during surgical treatment (open flap curettage) and will be examined by Immuno-histochemical     analysis. Immune-staining will be done using p53 monoclonal mouse anti-human antibody.   "
89777|NCT02110992|"     The purpose of this research study is to test the safety of a chemotherapy drug called     docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on     recurrent head and neck cancer that is not surgically removable.   "
89778|NCT02110979|"     The objectives of this study are to compare measurements in knowledge of decision options,     support for decision making, uncertainly in decision making, and clarity of values important     to decision making among two groups of type 2 diabetes patients, those who receive a Patient     Decision Aid and those who receive usual care.   "
89779|NCT02110966|"     The purpose of this study is to evaluate the success of inferior alveolar nerve block, after     the local application of Mepivacaine plus Tramadol in patients with symptomatic irreversible     pulpitis. Also, to evaluate the duration of the anesthetic effect when using Mepivacaine plus     Tramadol in the same anesthetic technique and patients group.      Hypothesis:      Local application of mepivacaine plus tramadol increases the successful of inferior alveolar     nerve block in patients with irreversible pulpitis.   "
89780|NCT02110953|"     This phase I trial studies the side effects and best dose of irinotecan-eluting beads in     treating patients with colon or rectal cancer that has spread to the liver and does not     respond to treatment with standard therapy. Irinotecan-eluting beads are tiny beads that have     been loaded with irinotecan hydrochloride, a chemotherapy drug. Drugs used in chemotherapy,     such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells,     either by killing the cells or stopping them from dividing. This treatment delivers the     chemotherapy directly to the tumor area inside the liver instead of to the whole body as with     systemic delivery of the drug. Irinotecan-eluting beads may work better that standard     chemotherapy in treating patients with colon or rectal cancer that has spread to the liver.   "
89781|NCT02110940|"     This clinical trial is the first study to apply neurodynamic mobilization, a nervous system     specific therapeutic exercise, on patients with rheumatoid arthritis(RA). Objective of the     study is to find out the effect of neurodynamic mobilization for joint inflammation in     patients with RA.   "
89782|NCT02110927|"     The purpose of this study was to analyze microcurrent short term effects used with aerobic     exercise on abdominal fat.   "
89783|NCT02110914|"     The treatment burden for patients with cystic fibrosis (CF) is significant and poor adherence     has been well-documented. The investigators hypothesize that a coaching intervention will     empower young adults with CF to manage their lives with CF and improve health-related quality     of life (HRQoL). The main aim of the study is to establish the feasibility and acceptability     of a life-coaching intervention.   "
89784|NCT02110901|"     This research study is designed to assess the safety and effectiveness of an experimental     drug called PRT-201 in patients both receiving or expecting to receive dialysis who have     chronic kidney disease and who are undergoing surgery to create a new access point to their     bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research     studies to help keep vessels patent when applied to the outside surface of the blood vessels     (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula     (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited     segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves     the patency of your AVF.   "
89789|NCT02110836|"     Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and     muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles     and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)     levels. Both liver and muscle glycogen are important for the ability to perform     intense/prolonged endurance exercise. Therefore, nutritional strategies which can maximise     the availability of glycogen in muscle and liver can benefit endurance exercise capacity.      The carbohydrates typically found in sports drinks are glucose and sometimes fructose. If     glucose only is ingested during exercise, then the maximum rate at which can be absorbed from     the intestine into the blood stream is ~1 g/min. However, if different sources of     carbohydrate (fructose) are used, which are absorbed through a different pathway, absorption     of carbohydrate can be up to ~1.8 g/min. With more carbohydrate available as a fuel, this     translates into an improvement in performance.      Sucrose is a naturally occurring sugar that is made up of a single glucose and single     fructose molecule. Therefore, theoretically, this can use the two different pathways of     absorption and also maximise carbohydrate delivery. It is not yet known however, what impact     this has on our liver and muscle glycogen stores during exercise. Therefore the aim of this     study is to assess whether sucrose ingestion influences liver and muscle glycogen depletion     during endurance exercise.   "
89790|NCT02110823|"     The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle     heart defects did after the first stage of surgery (Norwood operation). Infants enrolled in     the trial got one of two kinds of shunts during the Norwood; a modified Blalock-Taussig shunt     (MBTS) or right ventricle to pulmonary artery shunt (RV-to-PA shunt).      The purpose of this study is to learn if children (2-6 years of age) who were enrolled in the     SVR Trial do better with one of the two shunts (MBTS or RV-to-PA) in the years after surgery.   "
89791|NCT02110810|"     Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for     treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis     represents the most common and feared complication following ERCP. The reported incidence of     this complication is from 1% to 40% according to the presence of high-risk factors for this     complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective     series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients,     respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or     procedure-related.   "
89792|NCT02110797|"     Based on our clinical observations, many girls with RETT syndrome, a severe     neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very early     age (before age 10) and can lead to fractures, pain and a limitation in mobility. Few     epidemiological studies have estimated the frequency of osteoporosis in girls with RETT     syndrome and showed that they are more exposed then children with other neuro-developmental     diseases with a same degree of neurological handicap. However, the mechanisms that lead to     early osteoporosis in RETT syndrome remain unknown. Mutations in the MECP2 gene are found in     95% of RETT patients and preliminary experimental studies have shown that this can lead to     abnormal expression of the gene that codes for osteoprotegerin, a protein implicated in bone     remodelling by interacting with RANK-ligand.      In order to identify risk factors of osteoporosis in RETT syndrome and to understand the     pathophysiological mechanisms the study protocol includes:        1. Clinical evaluation of bone health (history of bone fractures, pain, nutritional status,          pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking ability,          vitamin D satus)        2. evaluation of the mineral density at the lumber spine using DEXA        3. measuring concentrations of osteoprotegerin and RANK-ligand   "
89793|NCT02110784|"     The aim of the present study is to investigate the efficacy, safety and tolerability of a     therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P.     vivax in endemic countries.   "
89794|NCT02110771|"     Social cognition impairments was highlighted for persons suffering with schizophrenia by     numerous studies. The use of treatment programs intended to treat specifically these deficits     through procedures of cognitive remediation, will allow decreasing their impact on everyday     life by improving abilities to understand and interact with others. Such tools could allow     also profits in terms of reduction of positive and negative of schizophrenia. The Gaïa     program is intended to improve the perception of the facial affects which is one of social     cognition processes impaired in schizophrenia.      Methods:      This is a multicenter, randomized, controlled study comparing people aged 18 to 45 years with     a diagnostic of schizophrenia according to the Diagnostic and Statistical manuel of Mental     disorders, 4th edition (DSM-IV-TR).      The GAÏA program will be compared to an already validated neurocognitive remediation program,     training attentional processes (RECOS).      100 patients will be randomized as follows: Arm 1, experimental: Gaïa (20h with therapist,     computer assisted method) Arm 2, control: RECOS (20h with therapist, computer assisted     method)      Condition: Schizophrenia Intervention: Behavioural: computer assisted cognitive remediation      Hypothesis:      A targeted cognitive remediation will more increased abilities in facial affects recognition     processes than a non specific, attentional cognitive remediation.      Primary outcome measures:      - Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after 10     weeks and 20 session of treatment.      Secondary outcome measures        -  Change from baseline in clinical, psychosocial, social cognition and neurocognitive          measures, after 10 weeks and 20 session of treatment and at 6 months follow-up.        -  Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after          treatment and 6 months follow-up.   "
89795|NCT02110758|"     The National Committee for Quality Assurance has worked with the National Coalition for     Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services,     Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to     define the Patient-Centered Oncology Care model. The purpose of this project is to pilot and     evaluate this model. Specific research questions are:        1. Does Patient-Centered Oncology Care improve patient experiences and quality of care?          Does it reduce undesirable events like emergency department visits and hospital stays?        2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices          and what factors affect adoption?      The demonstration will take place in oncology practices in southeastern Pennsylvania.     Practices will receive implementation support during the 24-month demonstration period. They     will be evaluated using patient surveys, quality measures, and measures of emergency     department and hospital use. Results from these practices will be compared in two ways: 1)     with their performance before they became oncology medical homes and 2) with other similar     practices.   "
89796|NCT02110745|"     The objective of this study was to determine (a) whether patients anesthetized with     intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia     and undescended testis operations and (b) whether intravenous propofol anesthesia has better     quality of recovery compared with sevofluorane anesthesia in the immediate postoperative     period after paediatric inguinal hernia and undescended testis operations.   "
89801|NCT02110680|"     Overactive bladder (OAB) is a very common problem that impairs the quality of life of about     17% of adult population in USA above the age of 40. The issues becomes more prominent with     getting older. OAB was determined by International Continence Society as urgency (immediate     desire to urinate that could not be postponed) with or without incontinence usually     associated with increased frequency and nocturia (urination at night). In 2012, American     Urologic Association published clinical guidelines for the treatment of OAB of non neurogenic     origin. Neuromodulation was proposed as the third line of treatment and two treatments were     recommended: sacral nerve neuromodulation (SNM) and posterior tibial nerve stimulation     (PTNS). Each of above mentioned procedures are invasive. SNM involves lead implantation in     operating room using X-ray guidance and anesthesia. PTNS involves needle insertion on the low     extremity.      The investigators would like to examine the efficacy of transcutaneous nerve stimulation     (TENS) in refractory to the first two lines of OAB treatment patients.   "
89802|NCT02110667|"     This study is being done to find out if transperineal ultrasound (TPUS) can help define the     prostate bed for radiation treatment planning and improve upon current methods of image     guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement     of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are     lying on their back in the position they will receive their treatment. Image-guidance is     required for the treatment of prostate cancer because the prostate bed shifts position     depending on how full the bladder and rectum are. Image-guided radiation therapy has been     done at Fletcher Allen Health Care for approximately three years. Most commonly,     transabdominal ultrasound images are obtained every day and compared to an ultrasound that     was done on the day of treatment planning. Adjustments in radiation field position can be     done on a daily basis by comparing these images. Transperineal ultrasound has never been used     for image-guidance. We completed two phases of an earlier study and have developed a TPUS     device and process that allow us to get clear ultrasound pictures of the prostate gland, and     now we would like to explore imaging the prostate bed left after radical prostatectomy.The     TPUS has three potential advantages over the transabdominal method we currently use:        1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get          clearer images, however it is difficult for some men with prostate cancer to comfortably          keep a full bladder. It is also particularly difficult to get good images in larger men          who have long distances from the skin surface to the prostate bed. TPUS is not dependent          on a man having a full bladder and should be less dependent on the size of the man.        2. TPUS images and the planning CT images can be acquired simultaneously. This is not          possible with the abdominal probe because it gets in the way of the CT machine.          Simultaneous imaging eliminates the possibility of the prostate bed shifting positions          during the time between imaging studies.        3. TPUS can be in place and acquire images during patient treatment (the abdominal probe          gets in the way of the treatment machine) and may in the future allow us to watch the          prostate bed during treatment. If we discover that we can accurately view the prostate          bed in real time, TPUS may ultimately allow us to treat even smaller radiation fields          and possibly decrease the risk of radiation complications.      Patients in this study will be treated for their prostate cancer with the standard image     guidance technique used at Fletcher Allen Health Care: transabdominal ultrasound. In     addition, one TPUS scan will be acquired at the time of the initial simulation.      To summarize, the two objectives of this study are:        1. To determine if TPUS can acquire usable, clinically pertinent IGRT images of the          prostate bed.        2. To preliminarily compare TPUS images of the prostate bed to images obtained with CT and          TAUS.   "
89803|NCT02110654|"     1. objectives. To compare the efficacy and the safety of mometasone furoate nasal spray          (MFNS; Nasonex 200μg, daily) alone versus a combination with montelukast (singulair          10mg, daily) in chronic rhinosinusitis (CRS) with asthma after functional endoscopic          sinus surgery (FESS) for improvement the clinical control of CRS        2. the clinical hypotheses. The investigators hypothesize that postoperative combined          montelukast and MFNS can better improve clinical control of CRS concomitant with asthma          after FESS compared with MFNS alone.        3. study design This study is a 9-month randomized, open-label, controlled interventional          study.   "
89804|NCT02110641|"     The specific aims of this study are to determine the efficacy and cost-effectiveness of a     weight loss program compared with usual care (control) treatment on 6-month changes in body     weight, body fat, serum hormones, and breast tissue markers associated with prognosis in     breast cancer survivors.   "
89805|NCT02110628|"     Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection     of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by     surgeons all over the world. Nowadays, in order to improve the quality of life, controversies     still exist to the reconstruction methods of total gastrectomy. Although roux-en-y     anastomosis is the most common method adopted after total gastrectomy for it is an easily and     safety method reconstruction method, but some problems still need us to solve, such as little     food reserves, less food intake per meal and fast gastric emptying. These problems     significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch     anastomosis is newly born method can significant increase the volume to improve postoperative     quality of life have been proven by some little sample size randomized control trail With the     improvement of the gastric cancer surgery, this study proposed by prospective randomized     controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y     type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of     life was evaluated according to the European Organization for Research and Treatment of     Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will     conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after     gastrectomy.   "
89806|NCT02110615|"     Mass in Motion Kids is a whole-of-community intervention in Fitchburg and New Bedford,     Massachusetts that incorporates evidence-based interventions across multiple sectors and at     multiple levels. The overall goal of the study is to examine the extent to which the     comprehensive, systematic intervention reduces childhood obesity among underserved children.      The clinical intervention implements evidence-based interventions each city's     federally-qualified community health center. Intervention components aim to improve primary     and secondary prevention of childhood obesity and implement changes at four levels:     clinician; parent-family; organizational; and environmental. We additionally provide training     and educational materials to other pediatric clinicians in the two communities. The clinical     intervention components include (1) advanced training on clinical quality improvement and     obesity prevention, assessment, management; (2) computerized, point-of-care decision support     tools for clinicians; (3) implementation of multi-disciplinary weight management programs     within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating     community health workers into the primary care and HWC teams; and (5) health center     environmental changes to support behavior change modification.   "
89807|NCT02110602|"     The investigators are conducting this research study to find out if eating low or high levels     of specific amino acids changes the levels of these same amino acids in the blood. Amino     acids are the building blocks of protein that are normally found in food. The amino acids the     investigators are studying are called branched chain amino acids. The investigators will look     at the levels (amount) of branched chain amino acids in blood before and after consumption of     specially prepared meals. The investigators hypothesize that circulating branch chain amino     acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high     BCAA-content diet.   "
89808|NCT02110589|"     Epilepsy is an episodic disorder which can result in recurrent seizures often associated with     hypertonia (muscle stiffening) and myoclonia (involuntary muscle jerking). Hypertonia can     often occur before full expression of the seizure and so detection of hypertonia could act as     an alarm to epilepsy patients and carers in order to prepare for a seizure event. Secondly, a     recording device for seizure frequency and duration is a valuable clinical tool for     collecting data for clinicians who manage the disorder in primary and tertiary care. The     investigators have developed a portable prototype for hypertonia detection using a     non-invasive, muscle activated, sensor that records seizure activity. The investigators now     want to test this sensor system in patients identified by Consultant Clinician Custodians     within the Wales Epilepsy Research Network (WERN). The Epidetect® prototype has been     developed by VIKEL LTD™ in collaboration with WERN - a Welsh Assembly funded network.   "
89809|NCT02110576|"     CLSI guidelines shall be followed to gather data from a minimum of one hundred and twenty     normal donors to create reference intervals for various Haemonetics reagents. Venous blood     from a minimum of 146 reference subjects shall be tested. Blood from 160 donors will be drawn     at the study site to account for aberrant or outlying data excluded for technical or other     reasons.   "
89810|NCT02110563|"     The purpose of this study is to assess the safety and tolerability of the investigational     anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid     particle suspension that targets the oncogene MYC. MYC oncogene activation is important to     the growth of many hematologic and solid tumor malignancies. In this study the Sponsor     proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell     growth.   "
89811|NCT02110550|"     Background: no randomized controlled trial has tried to compare treatment outcomes between     the IPS.emmax endocrowns and the IPS.emmax conventional crowns .      Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the     IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial     on patients with one or more intensive damaged molars requiring crowning and being treated at     the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at     the baseline assessment using a modified US Public Health Service (USPHS) criteria.      Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be     examined to find any excessively damaged molars requiring crowning. Forty patients will be     recruited according to specific inclusion criteria. Randomization will be performed using     computer-generated tables; allocation will be concealed using sequentially numbered opaque     and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60     years). They will be randomly distributed into two groups with 20 patients in each group (1:1     allocation ratio).      Intervention: Excessively damaged and endodontically treated molars will be restored with     IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.      Main outcome measure: marginal adaptation and anatomic form will be investigated clinically     and by apical radiographs at the baseline assessment using the modified (USPHS) at six     assessment times during an 18-month observation period.      Assessor blinding will be employed.   "
89812|NCT02110537|"     The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial     fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients     resistant to the antiarrhythmic drugs (AADs).   "
89813|NCT02110524|"     The purpose of this study is to assess safety and the inhibition of restenosis of the CVI     Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or     reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.      The primary endpoint for this analysis is late lumen loss at six (6) months.   "
89814|NCT02110511|"     The aim of this study is to determine the effects of bean physical form (whole versus     blended) and Beano on postprandial responses. The postprandial responses the investigators     will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. To     accomplish this aim the investigators will conduct a randomized, placebo-controlled trial in     overweight and obese but otherwise healthy (non-diabetic) men and women   "
89815|NCT02110498|"     This research is being done to learn more about pancreatic cysts. The tests that are     currently available are imperfect at determining exactly what type of pancreatic cyst a     person has, which cysts contain cancer, or what the risk is of developing cancer in the     future. The aim of this study is to use a combination of clinical, imaging, cyst fluid     analysis, and molecular markers to try to help develop better tools to answer these     questions.   "
89816|NCT02110485|"     The purpose of this study is to determine if a patient activation tool (PAT) can improve     decision making and patient centered outcomes in pediatric patients with appendicitis and     their caregivers choosing between antibiotics alone and appendectomy.   "
89817|NCT02110472|"     The Presbia Flexivue Microlens is a corneal inlay.   "
89818|NCT02110459|"     To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function     impairment after single intravenous (IV) infusion of POL7080   "
89819|NCT02110446|"     To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS)     patients.   "
89820|NCT02110433|"     Heart failure is a serious and common disease. HF is marked by a high rate of preventable     hospitalizations through proper care. As such, it is a key target for telemedicine programs.     However, currently published data are inconclusive. Investigators propose a multicenter     randomized study of innovative telemedicine involving the usual patient monitoring daily     weight monitoring, clinical signs and in one of three groups in our study of BNP testing in     the patient's home all associated with a regular education reinforcement. The objective is to     identify early cardiac decompensation to allow to treat ambulatory and thus prevent the     occurrence of more serious events such as death or rehospitalization.   "
89821|NCT02110420|"     First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and     multiple ascending doses of CC-90001   "
89822|NCT02110407|"     The aim of this study is to investigate whether a combination of intensive training of     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation     (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine     the underlying neuronal mechanism.   "
89823|NCT02110394|"     Prospective multicenter observational non-interventional study to assess routine clinical     practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia   "
89824|NCT02110381|"     An estimated 76 million adults in the United States over the age of 20 have hypertension     (HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25%     for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the     population together with increases in obesity and sedentary behavior, it is not surprising     that HTN is projected to increase significantly over the next several decades; with over 1.5     billion adults having HTN by the year 2025. Thus the public health implications to preventing     and/or reducing elevations in blood pressure are substantial.      This study compares the efficacy of two different non-pharmacologic interventions (device     guided breathing and isometric hand grip exercises) used alone and in combination for     lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension.     The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary     outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the     interventions by participants. The knowledge gained from this study can provide information     on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge     may be especially useful for patients for whom access to medications and health care is     limited and among patients unwilling to take or intolerant to pharmacologic therapies.   "
89825|NCT02110368|"     Bioequivalence study comparing the rate and extent of testosterone absorption for a test     formulation versus the reference product.   "
89826|NCT02110355|"     Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in     combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by a     direct comparison of AMG 232 combined with trametinib and dabrafenib versus trametinib     combined with dabrafenib alone.   "
89827|NCT02110342|"     The study aims to understand, using radiolabelled PF-04449913, how this compound is modified     by the body once it is absorbed. The study also aims to understand how much of the compound     is broken down and how much leaves the body unchanged.   "
89828|NCT02110329|"     Lymph node involvement remains the main criteria for postoperative chemotherapy in patients     with colon cancer (CC) without distant metastasis. To date, the prognostic value of the     somatic quantitative molecular alterations such as loss or gain of genomic region is not     established in CC.      AIMS & METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR     of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the     simultaneous detection of main quantitative somatic alterations in stage II-III CC.      Patients and Methods. We enrolled and collected all baseline characteristics of patients     operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a     simultaneous amplification of 9 selected target genomic sequences from literature: DCC     (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2     (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3).     Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral     tissue allowed us to identified gain or loss genomic region. The primary end-point was the     local and/or distant recurrence and relation between clinical and single or combined     molecular alterations and recurrence were evaluated.   "
89829|NCT02110316|"     The objective of this study is to obtain the absolute bioavailability of voriconazole in     critically ill ICU patients, because pharmacokinetics can be different in critically ill     patients due to alterations in function of various organs and body systems compared with     healthy volunteers.   "
89830|NCT02110303|"     Heart attacks are most commonly caused by rupture of fatty deposits (plaques) within the wall     of heart blood vessels. It appears that this process can also frequently occur without     causing any symptoms and these events likely explain the development of narrowing within the     heart arteries which can subsequently produce symptoms of angina (chest pain).      Previous research has shown a specialised scanner known as a PET (positron emission     tomography) scan can identify these recently ruptured plaques in patients without symptoms of     a heart attack and these patients have changes on a blood test (troponin) which suggest that     they are at higher risk of having a heart attack in the future. This study aims to identify     these patients using the PET scan and then see if the markers of increased heart attack risk     can be reduced by the use of a blood thinning medication (ticagrelor) which is already a well     recognised treatment for people who have suffered a recent heart attack.   "
89831|NCT02110290|"     This study is assessing quality of life in children with a physical disability who     participate in the Children's Hospital Colorado Hospital Sports Program (HSP), where children     with physical disabilities are able to participate in more organized sports and active     programs with the use of adaptive equipment. This study would assess a child's self reported     and parent perceived quality of life before and after child participation in HSP for the     winter season. The investigators aim to determine the level of child and parent happiness and     satisfaction in specific quality of life aspects including: physical activities and health,     feelings, moods, self perception, home life, friends, school, learning and bullying. The     investigators believe that children with any physical disability will have a more     satisfactory reported quality of life after participating in HSP for one or many years.   "
89832|NCT02110277|"     The purpose of this study is to develop technology to image the ovaries in order to better     evaluate ovarian disease and to study how these experimental imaging techniques might work     together or separately to improve our ability to detect ovarian cancer.   "
89833|NCT02110264|"     The aim of this trial is to assess the clinical utility, effectiveness, and cost implications     of treatment for incarcerated offenders with opioid use disorders who are randomly assigned     to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as     Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a patient navigator (PN)     XR-NTX+PN, and a drug education procedure (ETAU) before being released to the community. This     trial will investigate whether effective medication therapy used in non-incarcerated     populations will also be effective in incarcerated individuals. Empirical evidence     demonstrates that starting treatment before release greatly increases the probability of     successful outcome including reduced alcohol and drug use, increased employment rates, and     reduced recidivism rates.   "
90229|NCT02105038|"     The aims of the study are to better understand how upper extremity injury and immobilization     influences a patient's steering ability. Patients with acute distal radius fractures treated     with surgery will be recruited for study in a driving simulator. The results will hopefully     assist physicians to better counsel patients with upper extremity injuries on when it is safe     to return to driving.   "
89834|NCT02110251|"     Patients with peripheral arterial disease with symptoms of critical ischemia or reduced     tissue loss have a very high mortality and morbidity rate. So far, treatment strategies     focused on the preservation of life and limb by an open surgical or endovascular     revascularization, together with cardiovascular risk management and pain relief. Important     modifiable factors related to mortality and morbidity are not covered in the current national     and international guidelines. This study investigates the effects on mobility, mortality and     quality of life with supplementation of the standard treatment of critical limb ischemia with     supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor     management and lifestyle coaching will be taken in to account. The supervised exercise     therapy will take place under the supervision of a trained physiotherapist.   "
89835|NCT02110238|"     The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular     injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief     of knee OA.   "
89836|NCT02110225|"     The primary objective of the study is to assess the safety and tolerability of two dose     regimens of recombinant human nerve growth factor (rhNGF) eye drops solution administered     over 6 months versus a vehicle control in patients with typical retinitis pigmentosa. The     secondary objective of this study is to attempt to show a dose response by assessing the     potential efficacy of the rhNGF dose regimens for improving or slowing the deterioration of     visual function outcomes at 3 and 6 months. During a 6 month follow-up period patients will     be monitored to determine if there is evidence of a persistent biological effect after     discontinuation of the study treatment.   "
89837|NCT02110212|"     The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond     Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical     maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by     comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC)     and ultrasonic phacoemulsification.   "
89838|NCT02110186|"     The purpose of this study is to compare safety and outcomes of the following treatments of     lumbar disc herniation: (1) discectomy with posterior dynamic stabilization with those of (2)     discectomy alone or (3) discectomy with internal fixation and fusion.      Discectomy with posterior dynamic stabilization is proposed as the most effective treatment     to improve range of motion, and to be similarly effective to discectomy alone and discectomy     with internal fixation and fusion for other functional outcomes after surgery.   "
89839|NCT02110160|"     The purpose of this study is to assess the utility of FDG PET/CT in evaluating response of     bone dominant breast cancer to therapy. Eligible patients with bone dominant ER+ breast     cancer will undergo baseline FDG PET/CT for evaluation of their disease, after the start of     therapy they will undergo an FDG PET/CT scan at 4 weeks and again at 12 weeks. PET/CT results     will be compared to clinical measures of response, time to progression and overall survival.   "
89840|NCT02110147|"     This protocol has two parts - the Main Study which is 42 days in length and the Treatment     Extension which allows the patients who complete the Main Study to continue receiving     treatment with uridine triacetate. The purpose of this study is to replace oral     administration of uridine with oral administration of uridine triacetate in patients with     hereditary orotic aciduria who have received (or would reasonably be expected to receive)     clinical benefit from treatment with exogenous uridine. It is also to document the continued     clinical benefit of exogenous uridine when patients are switched from oral administration of     uridine to oral administration of uridine triacetate.   "
89841|NCT02110134|"     The purpose of this study is to compare a hydroquinone skin care regimen alone to a     combination of Revlite Laser treatment with a hydroquinone skin care regimen for the     treatment of melasma.   "
89842|NCT02110121|"     The purpose of this study is to evaluate the Picosure and Revlite Laser Systems for the     treatment of unwanted tattoos.   "
89843|NCT02110108|"     The purpose of this study is to evaluate the effects of the Revlite Laser System for     treatment of facial solar lentigines   "
89844|NCT02110095|"     The purpose of this study is to evaluate the Picosure Laser System for the treatment of     unwanted tattoos.   "
89845|NCT02110082|"     The purpose of the study is to determine the safety, tolerability and maximum tolerated dose     of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal     Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.   "
89846|NCT02110069|"     In this research study we want to learn more about which treatment works better for patients     diagnosed with a vascular tumor called Kaposiform Hemangioendothelioma (KHE) or other high     risk vascular tumors such as Tufted Angioma (TA). In these tumors, the blood cells that help     your blood clot called platelets become trapped in the tumor causing swelling, pain, and     bruising. Vascular tumors can be life threatening. There are few medical treatments that will     work to shrink the vascular tumor. Some doctors will use steroids and vincristine to try and     shrink vascular tumors.      In this research study, the study doctor will compare two different drugs to see which one     will work better to help shrink your vascular tumor. One of the drugs is vincristine.     Vincristine is approved by the Food and Drug Administration (FDA) to treat people with     cancer. Vincristine is used to stop the abnormal cells from growing such as cells that make     up blood vessels.      The other drug to be used in this study is sirolimus. Sirolimus is currently approved by the     Food and Drug Administration (FDA) to prevent transplanted organ rejection. Sirolimus is not     approved by the FDA for treatment of vascular abnormalities and is considered experimental.     Sirolimus belongs to a class of drugs call 'mTOR inhibitors'. mTOR (mammilian target of     rapamycin) helps cells to grow and may also help blood vessels to grow in a more normal     fashion. Sirolimus is currently being tested in patients with vascular tumors and cancer. In     vascular tumors, we hope sirolimus will stop the blood vessel growth.      Funding Source: FDA - OOPD (Office of Orphan Products Development)   "
89847|NCT02110056|"     The aim of this study is to investigate whether a combination of intensive training of     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation     (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine     the underlying neuronal mechanism.   "
91434|NCT02089282|"     In an attempt to answer if clavicular length changes after a fracture e.g. that any     shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a     novel ultrasound method.   "
89849|NCT02110030|"     Objective: The investigators aimed to compare the effectiveness of transcutaneous electrical     nerve stimulation (TENS) and interferential currents (IC) to improve shoulder functionality     and to reduce perceived pain in patients with subacromial impingement syndrome (SIS). Design:     Thirty-six patients with unilateral shoulder pain and diagnosed as having SIS were randomly     assigned into two groups: TENS (n=18; 51±7 years) and IC (n=18; 47±6 years). Patients in both     groups received fifteen 30-min sessions of the assigned treatment for a period of 3 weeks.     Before and after the treatment, shoulder pain was measured using a 100-mm visual analog scale     and shoulder functionality was measured using the Constant-Murley scale.   "
89850|NCT02110017|"     An impairment in social cognition in schizophrenia could account for the severe professional     and social difficulties among patients. Social cognition is the way the social world is     understood, perceived and interpreted. It includes all the process than enable oneself to     interact with another person, namely emotion perception and processing, theory of mind (ToM),     social perception, social knowledge and attributional style. Since these process are     interconnected, social cognition should be investigated through ecological tasks which     activate all of them together. Developing a social cognition ecological task, then testing     the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the     main objective of this study. The secondary objective is to seek a functional deficit among     the neural network of social cognition in patients with schizophrenia compared with healthy     subjects.      Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will     be included. The social cognition paradigm will be developed and the fMRI activations will be     compared to those of a visual cartoon based task, known to turn on the neural network of ToM.     BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and     compared to the signal of a second fMRI, made on the same 20 healthy subjects one month     later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).      Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to     test the secondary objective. We make the hypothesis of a fMRI functional alteration in the     cerebral network involved in social cognition, especially in the medial prefrontal cortex,     among patients compared with healthy subjects.   "
89851|NCT02110004|"     The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV     Catheter's ability to collect intracardiac signals within the desired chambers (atrial and/or     ventricle) in the heart for the analysis of complex arrhythmias.   "
89852|NCT02109991|"     The purpose of this study is to evaluate the CG-100 device, a single use, temporary     intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic     site, following colorectal surgery (open or laparoscopic).   "
89853|NCT02109978|"     This study will examine extreme responders to second- and third-line Type 2 Diabetes (T2D)     therapy using a retrospective approach and patients with slow or fast diabetes progression.   "
89854|NCT02109965|"     Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day     mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to     44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed     diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and     resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective     α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies     suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it     can reduce the mortality of endotoxemic rats and patients with severe sepsis. The     investigators will conduct two animal studies and one clinical trial to investigate the     effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with     endotoxemia and patients with severe sepsis and septic shock.      Sixty patients with severe sepsis and septic shock will be enrolled and randomized to control     group or dexmedetomidine group. In the control group, the patients will be treated according     to the clinical practice guideline. If sedation is required, non-dexmedetomidine sedative     agents will be used. In the dexmedetomidine group, the patients will be treated according to     the clinical practice guideline, and they will also receive continuous infusion of     dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed. The     sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil Gelatinase-Associated     Lipocalin), and BNP(B-type natriuretic peptide) will be examined at preset time points up to     24 hours. The vital signs, hemodynamic parameters, and survival of 28-day and 90-day will be     recorded and analyzed.   "
89855|NCT02109952|"     The purpose of this study is to monitor fracture risk associated with bone tumors in cancer     patients.      Previous studies from our lab have suggested that it is possible to compute the mechanical     strength of bones with tumors using computed tomography (CT) scans, which are like     three-dimensional X-ray pictures of the affected bones.      The next step in determining the usefulness of this type of strength analysis is to see if we     can accurately predict who is at risk for bone fracture and which patients are at high risk     of fractures.      This non-invasive analysis may help physicians determine the best treatment to reduce the     risk of an impending bone fracture in the future.   "
89856|NCT02109939|"     Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged     by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of     Week 8 of the study.   "
89867|NCT02109796|"     Previous studies show that one session of tDCS allow to improve muscle strength in     hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale     stimulation opposite to the cortical representation area of the injured hemisphere and a     simultaneous stimulation opposite to the homonyme the cortical representation area of the     healthy hemisphere. This approach seems to be the best relevant electrods configuration in     order to restore the inter-hemispheric balance.      We hypothesis that one session of tDCS with this electrods configuration allow to improve     paretic quadriceps strength in hemiparetic patients after stroke.   "
89889|NCT02109510|"     Investigators compared the patients' subjective postoperative symptoms and complications     between the double lumen endotracheal intubated patients under general anesthesia and     non-intubated patients under sedation and local anesthesia including        1. postoperative Visual scale of pain        2. postoperative sore throat/voice change        3. postoperative nausea/vomiting        4. intraoperative Arterial blood gas analysis        5. cost for anesthesia        6. morbidity   "
89857|NCT02109926|"     The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45     years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental     factors, especially during critical periods of development, is strongly suspected. Reliable     data on environmental exposure during this critical period are sparse.The discordant findings     and the limitations of available studies underline the importance to conduct studies with     sufficient statistical power to detect risk due to exposures during critical windows of     vulnerability.      We conduct a multicentric case-control study to assess this association. Cases and controls     will be enrolled during a 18-month period. They will be interviewed by professional telephone     interviewers about their occupational and residential history and about their domestic     exposure to pesticides and other nuisances.      An optional biological study to assess genetic polymorphisms known to be associated with     testicular cancer will be proposed to every cases and controls.      Mothers (or close relative) of cases and controls will also be contacted (with son's     agreement). If they agree to participate, they will also be interviewed about antenatal and     early life exposure of their sons to pesticides and other nuisances.      Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on     recruiting center.   "
89858|NCT02109913|"     The purpose of this study is to determine whether biomarkers could be found to gain more     insight in tumor characteristics in order to predict which patients will have a high chance     of a long progression-free survival. Postmenopausal patients with advanced metastatic breast     cancer who have progressed on anastrozole or letrozole will be eligible for this study.   "
89859|NCT02109900|"     This observational study aims the potential role of serum progesterone levels on the day of     oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF cycles.      There has been evidence, that increased serum levels of progesterone on triggering day are     associated with a decreased probability of pregnancy after IVF.      There is no study that investigate assocation between serum progesterone levels on the day of     oocyte pick-up and IVF outcomes. This study will be the first in this case.   "
89860|NCT02109887|"     PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in     immunocompromised patients including HIV-infected patients, transplant recipients, and     immunosuppressant users. About one third of non-HIV patients with PCP have the evidence of     co-infection with CMV. In this difficult clinical situation, physicians have difficulty to     decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection.     However, there is no objective test to differentiate true co-infection of CMV from innocent     bystander of CMV in those with PCP. The investigators thus evaluate the usefulness of     CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV     from inocent bystander of CMV. This findings may guide physicians to decide anti-CMV     treatment in patients with PCP and CMV co-infection.   "
89861|NCT02109874|"     This Phase I study will be conducted as a randomized, placebo-controlled, double-blind,     dose-escalation study in four groups of healthy adult male and female subjects who are     BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will     be conducted at one or two sites located in South Africa. The purpose is to evaluate the     safety and immunogenicity of two injections of AERAS 404 prepared with four escalating     amounts of antigen in healthy adult male and female subjects who are BCG-vaccinated,     HIV-negative, and have no evidence of tuberculosis infection.   "
89862|NCT02109861|"     The purpose of the study is to identify specific genes that are up- or downregulated in     multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib     (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned     standard myeloma treatment and will be given two hours prior to standard treatment. Blood     samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.   "
89863|NCT02109848|"     A prospective observational study on keratoconus and post-keratoplasty will be conducted. We     will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The     Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These scans     will be used to measure corneal thickness (pachymetry), corneal topography (anterior and     posterior) and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be     used when they become available. A comprehensive eye examination, Placido-ring corneal     topography, ultrasound pachymetry, and Scheimpflug camera imagery, will be performed for     comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by     regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by     standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze     formation.107, 108 In these cases PRK will be performed according to the standard of care and     will not be a part of the study protocol. The postoperative results will be observed at the     3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography,     ultrasound pachymetry, and Scheimpflug camera imagery   "
89864|NCT02109835|"     The purpose of the study is to identify a sub-group of diabetic patients at higher risk of     progression of coronary disease and also more likely to suffer from heart attack/angina and     heart failure. The total number of patients to be recruited in this study will be 250 with     type-2 diabetes but no known heart disease. These patients will have an objective measure of     the function of the lining of the arteries, CT scan of the arteries of the heart and an     ultrasound scan of the heart and arteries of the neck done at baseline along with blood tests     for identification new markers of malfunction of the lining and inflammation of the arteries.     Patients will be followed up at 18 months. During the follow-up visit, in addition to the     blood tests, the CT scan of the heart arteries and ultrasound of the heart and arteries of     the neck will be repeated to assess progression of the non-calcified, calcified and mixed     plaques in the coronary arteries.   "
89865|NCT02109822|"     The goal of this research study is to better understand current treatment practices for     pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient     Registry (CFFNPR)can be used for this type of study.   "
89866|NCT02109809|"     This phase I trial studies the side effects and best dose of low-dose total lymphoid     irradiation (LD-TLI) in treating patients with chronic graft-versus-host disease that has not     responded to treatment with steroids. LD-TLI is a procedure in which all of the body's major     lymph nodes are treated with small doses of radiation in order to reset the dysfunctional     immune system. LD-TLI may work as a treatment for graft-versus-host disease caused by a bone     marrow or stem cell transplant.   "
89868|NCT02109783|"     Numerous studies have investigated the effect of caffeine on athletic performance, but the     findings have not been consistent. This is due, in part, to the differences in response that     has been observed both within and between studies. Previous research in our lab has shown     that genetic variations affecting caffeine metabolism modify the association between caffeine     and heart disease. We hypothesize that the inconsistencies among studies relating caffeine     and athletic performance may be due to genetic differences in caffeine metabolism or     response. Male athletes will take part in an intervention of caffeine versus placebo, using a     randomized double-blinded placebo-controlled design, which will test various exercise     protocols (power, strength, anaerobic capacity, endurance) that are associated with     performance across multiple sports. We will conduct a genome-wide association study, which is     an approach that involves scanning for markers across the genomes of our study participants     together, not individuals, to find genetic variations associated with a particular trait such     as VO2 max, lactate clearance efficiency, muscle fiber type and changes in exercise     performance following caffeine. We will also examine known genetic variations that are     associated with caffeine metabolism and response, to determine if these genes also affect     response to exercise after ingesting caffeine. Subjects will be paid $50.   "
89869|NCT02109770|"     The purpose of this study is to collect blood from families with a child who has been     diagnosed with a chromosomal disorder including microdeletions in order to further develop a     non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.   "
89870|NCT02109757|"     The specific aim of this research is to evaluate the performance, effectiveness, and     long-term training benefits of a formal hearing protection fit testing program. This study     may provide preliminary evidence on the benefits of direct education/training combined with a     formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force     (USAF) employees. Currently, Public Health provides informal, subjective training to     employees; this practice may be altered by the results of this study.   "
89871|NCT02109744|"     To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in     the treatment of relapsed or refractory acute myeloid leukemia in patients of all ages, and     in the treatment of newly diagnosed leukemia in those who are older than 65 when diagnosed.   "
89872|NCT02109731|"     The purpose of this study is to determine the effectiveness and feasibility of upper airway     muscle physical therapy utilizing negative airway pressure (NAP) breathing training in     patients with Obstructive Sleep Apnea Syndrome (OSAS) in reducing both signs (apnea hypopnea     index) and symptoms (i.e., daytime sleepiness).The key to the proposed therapy is the use of     Negative Air Pressure when awake so that the increased reflex phasic drive to the muscles     will result in muscle conditioning. Interestingly, other studies have indicated that upper     airway muscle training may be useful in treating OSAS, but these studies used techniques that     were not scientifically designed{Puhan, 2006 8195 /id} or used a technique (electrical     stimulation) that was not well tolerated.{Lequeux, 2005 7514 /id}   "
89873|NCT02109718|"     The Effectiveness of open dressing with petrolatum jelly in minor burns has not been clearly     established. This study determined if the use of open dressings with petrolatum jelly as     effective as standard gauze dressing with silver sulfadiazine in treating minor burns in     terms of time-to-re-epithelialization, incidence of wound infection,incidence of adverse     reactions, and patient acceptance.      Non-extensive superficial partial thickness burns constitute a major proportion of burn     injuries. Conventional treatment involves regular changing of absorptive dressings including     the application of a topical antimicrobial, commonly silver sulfadiazine. A systematic review     has found insufficient evidence to support or refute such antimicrobial prophylaxis. Another     review compared silver sulfadiazine dressings with other occlusive and non-antimicrobial     dressings and found insufficient evidence to guide practice. Other research has suggested     that dressings with petrolatum gel are as effective as silver sulfadiazine. This trial sought     to compare the effectiveness of conventional silver sulfadiazine dressings with treatment     with petrolatum gel alone.   "
89874|NCT02109705|"     With this study the investigators would like to analyze the the role of periodontal disease     and especially the role of Porphyromonas gingivalis in initiation and progression of     Alzheimer`s Disease.   "
89875|NCT02109692|"     Duchenne muscular dystrophy (DMD) , caused by mutations in the DMD gene, is the most common     and most severe progressive dystrophy of the child. Although the development is rapidly     progressive , there is variability in the severity of the disease between DMD patients that     do not correlate with the type of mutations in the DMD gene. There are no easily measurable     biomarkers for monitoring the DMD or moderate form of the disease, Becker muscular dystrophy     (BMD ) . MicroRNAs (miRNAs) are involved in most cellular processes , and their expression     pattern is a signature of the state of a cell . They represent a potential class of     diagnostic and prognostic biomarkers. Some are specific for the skeletal myogenesis , and     changes in their pattern of expression are associated with muscle diseases including muscular     dystrophy. The levels of muscle- specific miRNAs are indeed greatly increased in the serum of     DMD and BMD compared to control patients .      The main objective of this is to validate the use of serum muscle-derived microRNAs as     biomarkers of DMD patients (compared with healthy subjects). Secondary objectives are i) to     investigate the relationship between circulating levels of these miRNAs and the severity of     the dystrophinopathy (DMD vs BMD) and also the progression of the disease (longitudinal     study), ii) to assess the specificity of these markers for dystrophinopathy (comparison with     other patients with muscular dystrophy), iii) to test candidate miRNAs recently identified     but not yet analyzed in the serum of patients.      Clinical data and samples will be recorded at each regular consultation. miRNA levels will be     quantified using Real Time Quantitative RT-PCR.   "
89876|NCT02109679|"     To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral     administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI     187004 and metformin given alone.   "
89877|NCT02109666|"     The purpose of this study is to estimate the retention rate of Abatacept over 24 months in     routine clinical practice in every participating country depending on the treatment line.   "
89890|NCT02109497|"     This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of     caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.   "
89879|NCT02109640|"     Two key requirements for discharge from hospital after major abdominal surgery are adequate     oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed     discharge after abdominal surgery due to delayed return of gut function, manifesting as     nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are     the mainstay of postoperative analgesic regimens after abdominal surgery and are highly     effective in achieving adequate pain control. However, opioids cause impaired gut function by     reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers such as     Alvimopan counteract these effects and can accelerate postoperative gut recovery but are     expensive and cause cardiac complications; alternative painkillers such as non-steroidal     anti-inflammatories are less effective than opioids and have been linked with increased risk     of anastomotic leaks.      Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride)     and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product     confines the naloxone action to the gut to reduce the unwanted side-effects on gut function.     Targinact has been shown in patients with chronic severe pain to provide comparable analgesia     to other opioid analgesics whilst reducing the unwanted side-effect of constipation.      The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia     after colonic resection with reduced postoperative gastrointestinal dysfunction. The surgical     procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a consistently     reproducible intervention with a postoperative gut dysfunction rate of up to 40% (prospective     data from the Edinburgh Colorectal Unit). The main outcome of the study will be return of     normal gut function at the time of planned discharge (Day 3).   "
89880|NCT02109627|"     The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard     treatment for AML, is safe to give to patients and to determine the best dose to give. The     study doctors want to see what effects, good and/or bad, the study drug has on subjects and     their AML. The study will look at what side effects subjects may have and how subjects feel     after receiving the study drug.   "
89881|NCT02109614|"     Aortic valve disease is the most common form of heart valve disease and is a major burden to     society. Aortic valve disease is also expected to become more prevalent with the aging of the     Canadian population. Currently, over 1 million individuals in North America have aortic     stenosis, which is a narrowing of the aortic valve, and leads to symptoms of heart failure     and sometimes death. Valve replacement with its potential costs and complications remains the     only avenue for treatment, once symptoms develop. Despite the major importance of this     disease, there are currently no medical treatments to prevent the development of aortic     stenosis.The lack of preventative treatments stems in large part to a poor understanding of     the causes of this disease.      Using cutting-edge genetic technologies, the investigators have recently identified that     individuals with a genetic predisposition to elevations in a type of cholesterol not normally     screened, called lipoprotein(a), have a much higher risk of developing aortic valve disease.     The investigators have also shown that lipoprotein(a) causes hardening of the valve, a very     early sign of valve narrowing. The investigators plan to evaluate in a randomized controlled     trial whether lowering this unusual form of cholesterol at an early stage of this disease     could slow or stop the development of aortic valve narrowing      The investigators are currently proposing a pilot project to evaluate the feasibility of this     type of study. If successful, our proposed treatment would be notable in two ways. First, it     would represent the first medical treatment to prevent valve disease, which could lead to     major reductions in the societal burden of this important disease. And second, it would     herald a major success for genomic medicine as it would represent one of the first treatments     borne from recent genetic studies. In these ways, our proposal could significantly impact the     health of many Canadians while also highlighting the innovative research performed in Canada.      Recruitment (n=238) for this project will be from the echocardiography laboratories of McGill     University affiliated hospitals. Individuals with aortic sclerosis or mild aortic stenosis     (aortic valve area [AVA] >1.5 cm2, mean gradient [MG] < 25 mmHG) and high Lp(a) will be     eligible for inclusion into this proposed study.   "
89882|NCT02109601|"     RESEARCH QUESTION:      Are hospitalized patients able to use a tablet computer (iPad) to take brief surveys, access     their patient portal (MyChart), and watch informational videos about their condition?   "
89883|NCT02109588|"     The main aim of this study was to examine the effect of a supervised physical exercise     program on the prevention of childhood obesity and its impact on the motor development of the     offspring.   "
89884|NCT02109575|"     The primary goal of this Multicenter Study is to develop and to evaluate a method for     measuring donor-specific cell free DNA in blood samples from transplant recipients as markers     of rejection. Blood samples obtained periodically from heart transplant recipients are     assessed for cell free DNA relative to clinical data in order to determine whether changes in     the level of cell free DNA indicate rejection.      This research study proposes testing a blood sample obtained from the heart transplant     recipient. The research seeks to establish whether this blood test will show when the patient     is beginning to or already rejecting the transplanted heart.      BACKGROUND Identifying if a transplant patient is beginning to or already rejecting the heart     is necessary, so that appropriate treatment can be started to halt the rejection. Heart     catheterization with biopsy is the usual method used for assessing whether a patient may be     rejecting the heart. There are also a number of other methods that transplant physicians will     use to look for signs of rejection including other blood tests, echocardiograms, obtaining     pressure readings during heart catheterization, and micro-array testing of blood obtained     during biopsy. These technologies are limited in ability to consistently and accurately     identify the presence of rejection.      The usual method of checking for rejection involves obtaining a sample of the heart tissue     (heart biopsy); biopsy can only be accomplished through heart catheterization which is an     invasive procedure that has risks associated with disturbing the heart such as puncturing the     heart or causing the heart rate to change or damaging tissue in the heart. Overtime,     repeating this invasive procedure can diminish the ease of the procedure because the veins     can become scarred and more difficult to access. For these reasons, researchers believe that     it would be good to have a blood test that gives information about the possibility of     rejection so that it may not be necessary to do as many heart biopsies. Also, a blood test     may be able to provide information about the heart or about rejection that is currently not     available at all.   "
89885|NCT02109562|"     The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with     placebo in the treatment of patients with schizophrenia.   "
89886|NCT02109549|"     There are preliminary data suggesting that patients suffering from non-insulin-dependent     diabetes mellitus, treated with metformin, have improved local tumor control. A reduction in     the tumor's hypoxia may be responsible for this phenomenon.      Therefore, the aim of this study is to test the hypothesis in three cohorts of patients     suffering from advanced stage non-small cell lung cancer and all undergoing concurrent     radiochemotherapy: 1. Patients with diabetes mellitus treated with metformin only; 2.     Patients with insulin-dependent diabetes mellitus not treated with metformin; 3. The     remaining patients serving as controls. Furthermore, tumor and treatment-related parameters     will be correlated with overall survival and morbidity.   "
89887|NCT02109536|"     The purpose of this study is threefold. First, the ability of experienced colonoscopists to     recognize the type of loop formed will be assessed and whether the use of the MEI improves     this accuracy. Second, to determine which maneuvers are used for loop reduction and whether     certain loops have set ways to reduce them. The third component will assess whether the     colonoscopist thought that the imager helped or not.   "
89888|NCT02109523|"     Coronary artery bypass grafting (CABG) surgery is often performed in elderly patients, but     non-adherence to post-CABG guideline medications is a common and serious clinical concern in     this age group. A recent systematic review found that higher medication adherence     significantly improved primary and secondary prevention of coronary artery disease outcomes     in all the included studies. Another systematic review assessed studies published from     1999-2009 about motivational interviews, such as implementation intention, in relation to     cardiovascular health. They found that motivational interview was an effective means of     changing behavior, while offering promise in improving cardiovascular health status. The     study is aimed to investigate effectiveness of long term volitional intervention in proving     medication adherence in the CABG patient.   "
89891|NCT02109484|"     This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The     study will examine the safety and immunogenicity of this vaccine first in healthy South     African toddlers. If the safety profile is deemed appropriate, the study will continue to     explore the safety and immunogenicity of the vaccine in healthy South African infants.      The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and     well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that     the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an     immune response in at least 80% of participants in at least one of the study groups.   "
89892|NCT02109471|"     A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults     (n=150) will be conducted at OHSU. The Optovue anterior segment OCT prototype will be used to     perform 3-D corneal scans. These scans will be used to assess opacity depth and measure     corneal thickness (pachymetry), corneal topography (anterior and posterior), and epithelial     thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become     available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound     pachymetry, and Scheimpflug camera imaging, will be performed for comparison   "
89893|NCT02109458|"     The goal of this study is to evaluate the feasibility and safety of navigation guided virtual     transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of     peripheral pulmonary nodules (PPN).   "
89894|NCT02109445|"     This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and     the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed     by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall     survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated     with anticancer therapies.   "
89895|NCT02109432|"     The purpose of this investigation is to evaluate participant use of a dedicated office pedal     desk with and without behavioral support.   "
89896|NCT02109419|"     While standard pencil-and-paper test have continued to be useful for the monitoring of     cognition, mood, and life space (LS) in the elderly they do have considerable limitations.     Use of these pencil-and-paper tests requires that individuals come to the clinic for     assessments, which results in significant clinical costs and practical limitations in the     conducting of assessments in large numbers of individuals, and provides a time consuming and     non-automated means of quantifying and recording changes in brain function. It is     increasingly recognized that there is a need to develop valid and reliable computer based     assessments to allow for the remote assessment of cognition, mood, and LS. Development of     computerized based assessments will significantly increase the scale, scope, and speed with     which cognition, mood, and LS can be measured in the elderly.      Helping Hands Technology LLC (HHT) has developed a number of web based assessments of     cognition, mood, and LS. These new computerized assessments will be developed using new     technology, and are based on the general principles found in existing pencil-and-paper based     assessments of cognition, mood, and LS. In addition, HHT is developing proprietary means of     reporting the results of the computerized assessments in an easy to use narrative format.     This study will focus on quantifying the feasibility and validity of using HHT computerized     assessments.   "
89897|NCT02109406|"     This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days),     three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and     safety of two dose levels of a dual pharmacology molecule with the combined properties of a     long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115)     delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic     obstructive pulmonary disease (COPD).   "
89898|NCT02109393|"     The investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary     rehabilitation treatment, previously conceived for Parkinson's disease, is effective for     patients with progressive supranuclear palsy and whether a driven gait orthosis (Lokomat) can     provide further benefits.   "
89899|NCT02109380|"     In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber     characteristics and insulin sensitivity will be determined.   "
89900|NCT02109367|"     This study involves women who are scheduled to have surgery for a pelvic or ovarian mass that     is suspicious for epithelial ovarian cancer (EOC). The physician will perform an additional     procedure on all patients known as 'culdocentesis'. This will be done just prior to their     scheduled surgery while the patient is under general anesthesia. Culdocentesis is a procedure     typically used to check for abnormal fluid in the space just behind the vagina. This pocket     of space is called the cul-de-sac. The purpose of this study is to determine if levels of     tumor markers, CA-125 and HE4, are measurable from the cul-de-sac fluid. If these tumor     markers are measurable from the cul-de-sac fluid and correlate with the patient's diagnosis,     this procedure may be used in the future as an additional diagnostic tool for EOC. In     addition, a single urine sample will be collected from each patient to measure the ratio of     good to bad estrogen. Investigators hypothesize this ratio will also correlate with EOC     diagnosis. Study results could lead to development of an alternative, minimally invasive and     low risk diagnostic tool in patients with an ovarian mass suspicious for malignancy.   "
89901|NCT02109354|"     The HIV Vaccine Trials Network (HVTN) is doing a study to test 2 experimental HIV vaccines in     combination with 2 licensed vaccines for tetanus and hepatitis B. HIV is the virus that     causes AIDS. Tetanus is an infection that causes muscular spasms. Hepatitis B is a virus that     can cause liver failure.      About 100 people will take part in this study at multiple sites. The US National Institutes     of Health (NIH) is paying for the study.      We are doing this study to answer several questions.        -  Are the HIV study vaccines safe to give to people?        -  Are people able to take the HIV study vaccines without becoming too uncomfortable?        -  How do people's immune systems respond to the HIV study vaccines? (Your immune system          protects you from disease.)        -  Can people's immune responses to a tetanus or hepatitis B vaccines help us understand          how their immune systems might respond to the HIV study vaccines?        -  Is there a common immune response to licensed vaccines like the tetanus and hepatitis B          vaccines?   "
91532|NCT02088008|"     A randomized, open-label, single dosing, two-way crossover clinical trial to compare the     safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan     160mg in comparison to each component coadministered in healthy male volunteers.   "
89903|NCT02109328|"     Background:      Progress in developing new effective therapies in advanced and relapsing urothelial cancer     has been stagnant in the last few decades and a paradigm shift is desperately needed. Aurora     kinase-A overexpression has been previously described in bladder cancer and spindle     checkpoint dysregulation is a common feature of human urothelial carcinoma (UC).      Alisertib (Millennium Inc.) is an orally available, selective small molecule inhibitor of     Aurora A kinase. Single agent and combination treatment of MLN8237 with either paclitaxel     (TXL) or gemcitabine synergistically reduced UC cell viability compared with either drug     alone. Hence, sequential application of MLN8237 and TXL warrants clinical investigation.     Phase 1 trials of both single agent and the combination with TXL defined the recommended     doses for phase 2 trials.      Methods:      A multistep approach will be adopted for this Phase 2 trial. A single-group run-in phase will     be conducted first with Alisertib 50 mg orally BID for 7 days, followed by 14d rest until     disease progression. In case of activity, a confirmatory randomized (1:1) trial of weekly TXL     plus either Alisertib or Placebo will follow, incorporating efficacy and futility boundaries     for early stopping. In a single-blind design, TXL will be given on days 1,8,15 q4wks at the     dose of 60 mg/m2 with alisertib and 80 mg/m2 with placebo. Alisertib dose will be 40 mg BID     days 1-3, 8-10 and 15-17, q4wks.      In the single-arm phase, primary endpoint (EP) will be Response Evaluation Criteria in Solid     Tumors (RECIST) 1.1 response-rate. 20 pts will be accrued, ≥3 responses will be required (10%     type I and 20% type II error constraints). An accrual of 110 pts is foreseen in the     randomized phase. Primary EP: progression-free survival (PFS), assuming an improvement in PFS     from a median of 2.5 months (H0) to a median of 4.5 months (H1) (44% hazard rate reduction,     10% drop out rate).      Eligibility will include diagnosis of metastatic UC and failure of 1-2 CT regimens     (single-arm) or 1 prior CT only (randomized phase). A relapse within 6 months of a     peri-operative CT will be counted as 1 line. Computed tomography and PET will be done every 2     cycles (2 months). Additional pharmacodynamic and translational analyses are planned on pre-     post- blood and tissue samples.   "
89904|NCT02109315|"     To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients     with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes     of endothelial function   "
89905|NCT02109302|"     The main objective of our study is to identify the first genetic etiology of primary     Premature Ejaculation (PE). We will test and evaluate the existence of genetic determinism     conferring susceptibility to a life-long syndrome (primary premature ejaculation) in some     patients. To this end, we plan to establish a collection of biological samples and a database     of patients with this extreme syndrome, which we will analyze by Genome Wide analysis. This     will lead to improvements in the biological understanding, the knowledge of physicians of     the disease, and should improve the patients' quality of life. Not all PE cases have the same     physiopathology and treatment efficiency, which depend on the specific mechanism involved in     the clinical context. Our work will make it possible to develop new therapeutic approaches     suitable for a large proportion of individuals presenting PE. This integrative approach     combining researchers, patients and ethics committees will facilitate profound reflection,     promoting the creation of suitable structures capable of receiving patients for appropriate     consultations. This unique study of PE should also favor industrial partnerships.   "
89906|NCT02109289|"     The primary goal of this preliminary project is to study the effect of etanercept, a medicine     approved by Health Canada for the treatment of rheumatoid arthritis, on the inflammation of     certain blood vessels. In particular, the inflammation of the aorta and the carotid arteries     will be studied.      This study's goal is to determine if etanercept (that blocks TNF (tissue necrosis factor)     alpha) could have an effect on blood vessel inflammation. As well, the information from this     study will be used to determine the number of patients to recruit in a future study.      This study will evaluate the effect of etanercept on 10 patients with rheumatoid arthritis at     one rheumatology clinic in Montreal. The 10 patients will be recruited at the Montreal     Rheumatology Institute (Institut de Rhumatologie de Montréal) and the images of the blood     vessels taken at a medical imaging center will be analyzed by the Montreal Heart Institute.      To evaluate vascular inflammation subjects will undergo a PET scan (Positron Emission     Tomography).   "
89907|NCT02109276|"     The proposed study will recruit patients with mild to moderate Fuch's dystrophy who need     cataract surgery alone. They will be randomly assigned to receive either spheric or aspheric     lenses. If both eyes of a patient need surgery, we will implant the same type of lens in each     eye in order to prevent imbalanced vision. We will measure their contrast sensitivity and     higher order aberrations before surgery and 3 months after surgery. We will compare the     change in these values between the two groups.   "
89908|NCT02109263|"     The aim of this study is to compare the impact of two non-medicinal strategies: the     breast-feeding and saccharose to measure effects in cerebral cortex during pain using near     infrared spectroscopy (NIRS)   "
89909|NCT02109250|"     In this registry it is planned to include all Belgian patients diagnosed with aggressive and     symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who     have been prescribed Caprelsa® (vandetanib).      The characteristics of patients receiving Caprelsa® (vandetanib) will be described. Therefore     real life data regarding demographic characteristics, evolution of the disease, RET mutation     status, the treatment before, during and after vandetanib, dose and duration of treatment     with Caprelsa® (vandetanib) and time of progression or death (if applicable) will be     included.   "
89910|NCT02109237|"     This study is to determine whether sleep disorders contribute to impaired quality of life and     mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive positive     airways pressure ventilation can improve sleep, quality of life and mobility in this patient     group.   "
89911|NCT02109224|"     This phase I trial studies the side effects and best dose of ibrutinib in treating B-cell     non-Hodgkin lymphoma that has returned or does not respond to treatment in patients with     human immunodeficiency virus (HIV) infection. Ibrutinib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth. It is not yet known whether it is     safe for patients with HIV infection to receive ibrutinib while also taking anti-HIV drugs.   "
89912|NCT02109211|"     The purpose of this study is to see whether altering the angle of the Magill forceps by 45     degrees will affect nasal intubation time in pediatric dental surgery patients.      The null hypothesis is that their will be no difference between the nasal intubation times of     those patients intubated with the conventional Magill forceps and those intubated with the     altered Magill forceps.   "
90252|NCT02104739|"     This project addresses cardiovascular disease risk in patients with prediabetes. Levels of     lipids after eating a meal (postprandial lipids) are strong independent predictors of     cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid     metabolism. These medications will be studied for their effect in reducing both postprandial     lipid levels and arterial dysfunction.   "
89913|NCT02109198|"     The purpose of this study is to determine the feasibility of combining PoNS therapy with     standard vestibular and balance therapy with the proposed double-blind design; evaluate     preliminary indications of efficacy. This study is also evaluating recruitment rate,     completion rate, device usability, and outcome measures feasibility.        -  Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be          recruited over the 36 week pilot recruitment phase.        -  Completion and compliance: 90% of subjects will complete the study, 90% of sessions          within each subject will be completed, and for completing subjects, 100% of measures          will be completed.        -  Useability: all therapists and subjects must rate useability as good or better.        -  Success of blind: subject accuracy at guessing group membership must be at or near 50%.   "
89914|NCT02109185|"     The study will compare the safety and efficacy of a generic mometasone nasal spray to the     reference listed drugs in the treatment of seasonal allergic rhinitis. Additionally both the     test and the reference formulations will be tested for superiority against a placebo nasal     spray.   "
89915|NCT02109172|"     This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when     administered using a jet nebulizer for 7 days in a cross-over design to patients with     moderate to severe chronic obstructive pulmonary disease.   "
89916|NCT02109159|"     The investigators will conduct a two-arm, randomized controlled trial of the effect of     emotional content in online videos on the extent to which the video is disseminated     (forwarded). Dissemination can be assessed in terms of the number of views which can increase     as a result from sharing and forwarding of the video.      In this study, an experiment video and a control video, both of which are approximately 2.5     minutes long, will be uploaded on YouTube, the most visited video sharing website. The videos     concern the WOMAN trial, a large RCT of tranexamic acid in postpartum hemorrhage. The     experimental group will receive a video with strongly emotional content (an interview with a     postpartum hemorrhage survivor and her husband). The control group will receive a short video     in which a researcher conveys the same information (but without the first hand experience of     the survivor and her husband). Otherwise, the two videos are identical.      Participants, selected from clinicians and researchers in obstetrics and gynecology, will be     randomly allocated to two groups. An e-mail with a link to either of the videos will be sent     to the participants. In the e-mail, they will be asked to watch the video and forward the     link to their colleagues if they find it helpful.      The primary outcome is video forwarding. The secondary outcome is the number of access to the     video that each participant generated.      Data will be collected for 14 days after the e-mails are sent to the participants. The     relative risk (RR) of forwarding the videos will be calculated as effect measure and compared     using chi-square test. The distribution of the numbers of access to the video that each     participant generated will be compared using Wilcoxon signed-rank test.      The hypothesis is that an online video with emotional content has higher chance of being     forwarded to other people and therefore, gets higher number of views than an less emotional     online video.   "
89917|NCT02109146|"     1. Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver,          representing the third leading cause of cancer-related death worldwide.        2. Its overall dismal prognosis is a result of high incidence rates of metastasis and          postoperative recurrence, in particular the intrahepatic recurrence.        3. TACE is the most widely used primary treatment for unresectable HCC. It was also used as          the optional treatment of relapsed disease. However, the efficacy of TACE used as          adjuvant therapy following hepatectomy remains controversial.   "
89918|NCT02109133|"     Intraocular pressure is significantly increase during robot-assisted laparoscopic radical     prostatectomy which is performed in a steep trendelenburg position at prolonged times of     pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical     visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing     Robot-Assisted Laparoscopic Radical Prostatectomy.   "
89919|NCT02109120|"     1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration          cross CEA will be identified.        2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level          will increase in the early stage after CEA.   "
89920|NCT02109107|"     The purpose of this study is to determine whether low level laser light therapy is effective     in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period.   "
89921|NCT02109094|"     The investigators seek to examine the metabolic changes that occur amongst obese and lean     pregnant women with normal glycemic control as well as pregnant women with diabetes mellitus     (gestational diabetes and pre-existing type 2 diabetes mellitus) compared to non-pregnant age     matched controls. Given the adaptive tendency of the maternal body to use alternative energy     sources such as ketones and free fatty acids rather than glucose and to shunt glucose and     amino acids to the fetus, the investigators hypothesize that the amino acid and fatty acid     profile will be reflective of this adaptive change and that maternal insulin resistance will     result in alterations in this pattern in both the plasma and CSF. Furthermore, the     investigators also hypothesize that maternal degrees of insulin resistance will also be     reflected in CSF hormonal changes.   "
89922|NCT02109081|"     Postoperative delirium is commonly observed in elderly patients in the postanesthesia care     unit (PACU) and during the first 2-3 days following surgical procedures. This is an important     clinical problem in the geriatric surgical patient; morbidity and mortality rates are     significantly higher in patients who develop delirium. At the present time, the etiology of     delirium has not been precisely defined. However, studies suggest that inflammation related     to the surgical stress response is an important contributing factor in inducing     neuroinflammation and subsequent cognitive dysfunction and delirium. Therefore it is possible     that agents which attenuate perioperative inflammation may reduce the risk of the development     of delirium following surgery. Dexamethasone is a potent corticosteroid that is used by     anesthesiologists primarily as an antiemetic agent. Small doses of dexamethasone have also     been demonstrated to significantly reduce the release of inflammatory markers after surgery.     The anti-inflammatory effects of corticosteroids have the potential to beneficially impact     neuroinflammation and the risk of developing postoperative delirium. The aim of this     randomized, controlled, double-blinded investigation is to determine if dexamethasone,     administered at induction of anesthesia, can decrease the incidence of delirium at the time     of discharge from the PACU and during the first 2 days following surgery.   "
89923|NCT02109068|"     The specific aims of this study are to determine the efficacy and cost-effectiveness of a     weight loss program compared with usual care (control) treatment on 6-month changes in body     weight, body fat, and serum hormones in breast cancer survivors.   "
90253|NCT02104726|"     To compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs.     fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the     procedure.   "
91533|NCT02087995|"     To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous     monitoring system when compared to a laboratory reference measurement.   "
89924|NCT02109055|"     The major cause of mortality worldwide is due to cardiovascular diseases. A way to treat     these diseases is coronary artery bypass grafting, one of the most common surgical procedures     in the world. The incidence of post-operative complications contributes to functional decline     of the patient, reduced quality of life and post-discharge mortality. Also, cardiac surgery     leads to changes in lung capacity and respiratory muscle strength, causing a decrease in the     function lung. Physical therapy proves to be an effective tool to combat changes resulting     from cardiac surgery, demonstrating beneficial results in the pulmonary function, functional     capacity, and peripheral and respiratory muscle strength. The Pilates method has been studied     as a therapeutic way to healthy subjects and various kinds of diseases, but there are no     studies in the literature evaluating the effect method in patients after coronary artery     bypass surgery.      The aim of this study is to investigate the effect of Pilates on functional capacity , flows     and lung volumes, respiratory and peripheral muscle strength after coronary artery bypass     grafting.      Randomized clinical trial in which patients will be eligible after elective coronary artery     bypass surgery, randomly allocated into two groups : conventional physiotherapy group (n =     15) and Pilates method associated with conventional physiotherapy group (n = 15). The     outcomes will be assessed by blinded evaluator and data randomization will be performed     through by electronic randomization.The interventions will take place during the length of     stay in the hospital, totalizing a maximum of six days of intervention.      It is expected that the application of the Pilates method exercise method associated with     conventional physiotherapy in patients in postoperative coronary artery bypass grafting     improves functional capacity, flows and lung volumes and respiratory and peripheral muscle     strength.   "
89925|NCT02109042|"     The purpose(s) of this study is to measure how much of the study drug gets into the blood     stream and how long it takes the body to get rid of it when given in multiple doses,     subcutaneously (SQ) (by inserting a needle just under the surface of the skin in the lower     abdominal area), to post-menopausal female participants. Information about any side effects     that may occur will also be collected.      This study will also be looking for special markers called biomarkers that can be used to     study osteoporosis and/or the effects of the study drug.      There will be 2 parts to this study. The first part will last approximately 6 weeks and the     second part will last approximately 7 weeks.   "
89926|NCT02109029|"     LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.     This study is designed to understand how the body handles the investigational drug, and to     measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves     intravenous (IV) infusion of the investigational drug and a procedure to measure     concentrations in the fat tissue. Both parts of the study will be conducted in participants     with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to     complete.   "
89927|NCT02109016|"     The purpose of this study is to determine whether lucitanib is safe and effective in the     treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor     (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor     (PDGF) related genetic alterations.   "
89928|NCT02109003|"     Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff     underinflation and overinflation frequently occur in critically ill patients, resulting in     increased risk for microaspiration and tracheal ischemic lesions.   "
89929|NCT02108990|"     Recent research has identified heightened sensitivity to social rejection as a core feature     of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious     behaviors characteristic of the disorder.      Therefore targeting therapy towards the reduction of rejection sensitivity may improve the     low rates of effectiveness of current pharmacological and behavioral therapies. Therefore,     this proposal tests a theoretically-based pharmacological approach that specifically targets     the heightened sensitivity to rejection experienced by BPD patients.      In prior research with normal controls, it was shown that chronic treatment with the physical     pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social rejection     (using fMRI) as well as self-reported feelings of rejection in a daily diary study.      It is the aim of this research project to determine if the over-the-counter analgesic,     acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD     patients. The goal of this proposal is to use an open-label design to determine if     acetaminophen improves symptoms in BPD patients.   "
89930|NCT02108977|"     Genetic counseling has benefits for individuals and their family members in their health care     decision-making. Provision of genetic counseling has been deemed standard of care by several     medical organizations and incorporated into clinical guidelines, such as those of the US     Preventive Services Task Force. To better comply with these guidelines, Genomic Medicine     Service (GMS) recently established at the Salt Lake City, Utah VA medical center to provide     genomic services and counseling as a part of VA Patient Care Services. For Veterans for whom     in-person genetic counseling in not feasible, GMS conducts counseling either via telephone or     videoconferencing. Although both of these methods can be effective for delivering genetic     counseling, each has its relative advantages and disadvantages. The specific aim of this     study is to gain a better understanding of the advantages and disadvantages of these two     modalities. This information will be useful not only for genetic counseling but also other     interventions that use telephone or videoconferencing to access patients.   "
89931|NCT02108964|"     To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) (Phase l     part) of EGF816 and to investigate the anti-tumor activity of EGF816 (Phase II part).   "
89932|NCT02108951|"     The purpose of this Australian study is to assess the efficacy and safety of nilotinib 300mg     twice daily in patients with chronic myeloid leukemia chronic phase who are intolerant but     responsive to 1st line treatment with imatinib or dasatinib. Eligible patients have been     previously treated with imatinib or dasatinib for at least 3 months and are experiencing     non-hematologic toxicity whilst having documented responses that meet PBS authority for 1st     line treatment of CML without current MR4.5.   "
89933|NCT02108938|"     The primary aims for this research are to 1) characterize brain changes in patients with CD     compared to age and gender-matched controls and 2) relate these brain changes to measures of     disease activity and pain severity.   "
89934|NCT02108925|"     The project will test the hypothesis that lung ventilation during exercise is unaffected by     oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea,     heart rate and blood pressure will be studied.   "
89935|NCT02108912|"     This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic     benefits for persons post stroke that learn to walk utilizing early treadmill training     post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based     gait training during the same time period. Participants (n=30) will be adults who have     completed acute rehabilitation following a stroke. Random assignment will be to either the     ESTT or traditional gait training protocol during the outpatient rehabilitation phase.        1. Group A: Traditional outpatient therapy (n = 15)        2. Group B: Treadmill training (ESTT) outpatient therapy (n = 15)   "
89936|NCT02108899|"     When people are tested on a previously learned material, they will later remember it better     even when compared to a condition where they can re-study it. This phenomenon is called     retrieval practice and is supported by an extensive research literature mostly carried out in     normal students. This paradigm begins to be used in cognitive remediation programs in     patients suffering from memory difficulties.      The objective of this study is to investigate whether retrieval practice is spared in     patients with schizophrenia.      If effective, this method could be used in cognitive remediation programs.      Since episodic memory difficulties are supposed to be secondary to deficits in the     initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that     retrieval practice is spared in schizophrenia.   "
89937|NCT02108886|"     Preterm birth is a major public health problem, and actual treatments are not very efficient.     The purpose of this study is to test the efficiency of a combined use of Montelukast and     Nifedipine to treat preterm labor. Investigators aim to reduce uterine contractions more     efficiently than with the use of Nifedipine only.   "
89938|NCT02108873|"     Our objectives were to estimate the prevalence of nonattendance at outpatient offices, to     identify the characteristics of appointments for which nonattendance was more likely to     occur, and to generate a predictive model that could be applied to each appointment to     estimate the probability of nonattendance.   "
89939|NCT02108860|"     Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of     abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing     non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be     randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous     injection once a week. Participants will continue on study treatment for a minimum of 12     months unless they experience a disease relapse or disease flare.      Participants who experience a non-severe disease relapse, non-severe disease worsening, or     who have not achieved remission by month 6 will have the option of entering an open-label     trial period whereby they would receive open-label abatacept.   "
89940|NCT02108847|"     The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks     performed before surgery help to reduce pain after elective total hip replacements.   "
89941|NCT02108834|"     For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine     whether it offers real benefits in terms of patient outcome from major surgery, compared with     general anesthesia. Although it is clear that regional analgesia in association with general     anesthesia substantially reduces postoperative pain, the benefits in terms of overall     perioperative outcome are controversial. The aim of this study is to evaluate the effect on     short and long-term postoperative outcomes of adding regional analgesia to general     anaesthesia in thoridetomic patients.   "
89942|NCT02108821|"     A disturbance in the diversity of gut bacterial composition could be linked to several immune     mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified into     Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from abnormal     immune reaction to resident gut bacteria.The process of fecal microbiota transplantation     (FMT) where fecal bacteria from a healthy individual is transferred into a recipient, has     recently received attention as an alternative therapy for individuals affected with these     life-altering diseases. In this study, the investigators will perform fecal transplantation     on the subjects meeting inclusion criteria, to determine the efficacy and safety of this     therapy in subjects with IBD (CD and UC) who are not responding to first line therapy, and     are in a flare.   "
89943|NCT02108808|"     Fractional flow reserve (FFR) is an established invasive method for assessing the     physiological significance of coronary artery stenosis. Adenosine, an important endogenous     regulator of coronary blood flow during both stress and ischemia, is widely used to achieve     conditions of stable hyperemia required for measurement of FFR.      Studies in healthy volunteers and in patients with acute coronary syndrome (ACS) post     percutaneous coronary intervention (PCI) receiving ticagrelor revealed a differential     coronary blood flow velocity response during increasing doses of adenosine compared to     placebo or prasugrel treated subjects, respectively. It has also been demonstrated that     patients treated with ticagrelor have increased plasma adenosine levels. Therefore, it has     been hypothesized that the degree of hyperemia obtained with adenosine infusion may be     greater in patients on ticagrelor than that obtained in patients taking clopidogrel or     prasugrel. If this proves to be true, it would lead to a lower FFR value with possible     important clinical implications in ticagrelor receiving patients in need for FFR measurement.      This is a prospective, single center, randomized study of parallel design. Consecutive     ticagrelor naive patients who are referred for coronary angiography and have an     angiographically moderate to severe de novo stenosis (>50% and <90% diameter by visual     assessment) in at least one major epicardial coronary artery amenable to PCI are candidates     for this study. Patients after informed consent will be randomized (hour 0) to receive     immediately post FFR (with adenosine iintravenous infusion at 140 μg/Kg/min for a 3 minute     period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading dose     (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.   "
89944|NCT02108795|"     The aim of the present study is to assess the effect of postoperative remifentanil infusion     on the incidence of emergence agitation in preschool-aged children undergoing strabismus     surgery with sevoflurane anaesthesia.   "
89945|NCT02108782|"     This phase II trial studies how well dovitinib lactate works in treating patients with     pancreatic neuroendocrine tumors. Dovitinib lactate may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
89946|NCT02108769|"     Our aim is to analyze two ancient Tamil practices (chanting and breathing exercise) if they     are capable of stimulating saliva containing agents that can be beneficial to the nervous     system. Our study subjects will perform Tamil chanting and Tamil breathing exercise. Saliva     will be collected before, during and after the exercises. We will quantify the specific     proteins in these salivary samples. The results will benefit further studies in various     patient populations.   "
89947|NCT02108756|"     The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to     treat upper gastrointestinal ulcer bleeding.   "
89948|NCT02108743|"     The purpose of this study is to determine if dynamic hyperinflation seen in patients with     idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.   "
89950|NCT02108717|"     1. Purpose           - The investigators aim to evaluate the feasibility of iPhone based remote control          system as a real-time remote CT reading tool for suspected appendicitis under 3G network          and the suboptimal illumination.        2. Methods             -  A total of 120 abdominal CT examinations; sixty had no findings of appendicitis,               while the other sixty showed signs of acute appendicitis, were selected. The 16               raters reviewed these images using an LCD monitor of the PACS workstation and also               an iPhone which was connected to the PACS workstation via remote control system,               grading the probability of presence of acute appendicitis on each examination by a               five Likert scale.             -  The investigators will compare the diagnostic performance between two devices.   "
89951|NCT02108704|"     It has been hypothesized, based on epidemiological observations, that Helicobacter pylori     (HP) infection may play a role in the pathogenesis of Parkinson's Disease (PD). Previous     studies have also shown that HP eradication therapy may result in improvements in levodopa     pharmacokinetics and motor fluctuations. This study aims to examine the effects of HP     eradication, using a double-blind randomized placebo-controlled trial design in a relatively     large cohort of patients. Outcomes of interest include motor function, gastrointestinal     symptoms and health-related quality of life. The investigators hypothesize that HP     eradication will lead to improvements in motor function. The primary outcome of interest is     the ON-medication Unified PD Rating Scale (UPDRS) Part III score at 3 months. Secondary     outcomes include Purdue Pegboard Score, Timed Test of Gait, Dyskinesia and Bradykinesia     scores measured by Parkinson's Kinetigraph (PKG), 72 hour Diary, Leeds Dyspepsia     Questionnaire (LDQ), Parkinson's Disease Questionnaire (PDQ-39), UPDRS Part I, Part II and     Part IV; and Montreal Cognitive Assessment (MOCA).   "
89952|NCT02108691|"     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement     of body fat. The investigators measured decrement of body fat parameters , including Body Fat     Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.   "
89953|NCT02108678|"     The purpose of this research study is to examine whether a one-day group workshop,     integrating principles from Acceptance and Commitment Therapy and Migraine Education, will     result in greater improvements in depressive symptoms and functioning impairment in patients     with comorbid migraine and depression than a similar one-day group workshop with Migraine     Education only.   "
89954|NCT02108665|"     The main objective of this study is to compare the data of Hystérosalpingo-MRI with intra     cavitary injection of diluted gadolinium salts with the classic hysterography, which allows     to realize at once with no irradiating examination, a complete assessment of the female     infertility.   "
89955|NCT02108652|"     This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment     in participants with locally advanced or metastatic urothelial bladder cancer. Participants     will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are     treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1     are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who     have progressed during or following a prior platinum-based chemotherapy regimen. Participants     in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on     Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease     progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or     unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of     clinical benefit or unmanageable toxicity.   "
89956|NCT02108639|"     Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.   "
89957|NCT02108626|"     The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current     smokers under four distinct conditions: after smoking a conventional cigarette, an electronic     cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after     taking a nicotine lozenge. Participants will be asked to attend four morning study visits     after overnight smoking abstinence. Standardized questionnaires will be used to assess     changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes     in reducing craving by replacing the behavioral component of smoking with minimal risk of     adverse effects.   "
89958|NCT02108613|"     Approximately half of men treated for prostate cancer will be offered hormone deprivation     therapy during their cancer experience. The secondary effects of this treatment can result in     osteoporosis, cardiovascular disease, stroke, diabetes, and diminished sexual health. To     promote healthy lifestyle choices for couples and maintain their intimacy and emotional     health we propose the Living Well, an innovative program that combines nutrition, physical     activity, and sexual health initiatives in one integrated service. This project will be     piloted at the Vancouver Island Centre with an expected 100 patients over 1 year. Over a six     month period both the experimental and control groups will have access to a workbook     (designed for men with prostate cancer and on hormone deprivation therapy) and sexual health     counseling. The experimental group will also have access to an exercise and a nutritional     program and support by volunteers to keep motivated. Assessment will look at quality of life,     physical factors, and biomarkers associated with secondary disease.   "
89959|NCT02108600|"     Randomized open label clinical trial in which 48 renal transplant recipients with     inflammation in the 6 month allograft biopsy will either continue usual immunosuppression or     receive monthly Actemra (Tocilizumab) infusions for 6 months in addition to usual     immunosuppression.   "
89960|NCT02108587|"     This clinical trial studies how well optical coherence tomography works in staging patients     with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer     based on the size and/or extent (reach) of the original (primary) tumor and whether or not     cancer has spread in the body. It also helps the doctor plan the appropriate treatment.     Optical coherence tomography is a procedure that uses infrared light waves to give     three-dimensional pictures of structures inside tissues and organs. The pictures are made by     a computer linked to the light source. Optical coherence tomography may be effective in     staging patients with upper-tract urothelial carcinomas.   "
89961|NCT02108574|"     This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis     (hay fever) in a park setting.   "
89962|NCT02108561|"     Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are     not routinely repeated on surgical specimens (SS). However, preliminary data suggests that     testing these biomarkers, on SS when compared to CNB samples can lead to different results.     Our hypothesis is that The aim of this study is to identify a group of women with invasive     breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas     of HER2 amplification are not missed. Another aim is to determine whether further HER2     testing on the SS in select patients would lead to changes in breast cancer treatment     options.   "
89963|NCT02108548|"     The purpose of this study is to evaluate the safety and tolerability of single and multiple     ascending oral doses of ASP7657 in healthy subjects.   "
89964|NCT02108535|"     The evidence is insufficient to determine whether the types of dressings containing silver     differ as the time/proportion to complete healing of the wound and pain. We will analyze     cost-effectiveness of these dressings in outpatients, considering the service provided by the     National Public Health System.   "
89965|NCT02108522|"     Patients enrolled on this study will have received a stem cell transplant. After a     transplant, while the immune system grows back the patient is at risk for infection. Some     viruses can stay in the body for life and if the immune system is weakened, like after a     transplant, they can cause life threatening infections.      Patients enrolled on this study will have had an infection with one or more of the following     viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), BK virus, JC virus, adenovirus or     HHV6 (Human Herpes Virus 6).      Investigators want to see if they can use a kind of white blood cell called T cells to treat     infections of these viruses after a transplant. Investigators have observed in other studies     that treatment with specially trained T cells has been successful when the cells are made     from the transplant donor. However as it takes 1-2 months to make the cells, that approach is     not practical when a patient already has an infection.      Investigators have now generated multivirus-specific T cells (VSTs) from the blood of healthy     donors and created a bank of these cells. Investigators have previously successfully used     frozen multivirus-specific T cells from healthy donors to treat virus infections after bone     marrow transplant and now have improved the production method to make it safer and target     more viruses.      In this study, investigators want to find out if they can use these banked VSTs to fight     infections caused by the viruses mentioned above.   "
89966|NCT02108509|"     The purpose of this study is to define the prevalence of low bone density     (osteopenia/osteoporosis) in patients with chronic pancreatitis. Secondary aims include     investigating the prevalence of hypogonadism (low sex hormones) in patients with chronic     pancreatitis and determining if hypogonadism and/or use of narcotic pain medications are risk     factors for low bone density in this patient population.        1. Hypothesis:           Patients with chronic pancreatitis are at increased risk of low bone density          (osteopenia/osteoporosis), and hypogonadism (low sex hormone levels) and narcotic pain          medication use are independent risk factors for the development of low bone density in          this patient population.        2. The outcome measures include:           i) Prevalence of low bone density (osteopenia/osteoporosis) in patients with chronic          pancreatitis (as determined by DXA scan and fracture history).           ii) Prevalence of hypogonadism (low sex hormones) in patients with chronic pancreatitis          (as determined by sex hormone levels and clinical history).           iii) Identification of hypogonadism and/or opioid use as risk factors for low bone          density in patients with chronic pancreatitis (as determined by univariate and          multivariate analysis of multiple risk factors).        3. After obtaining written consent from potential subjects, a questionnaire will be          performed outlining risk factors for low bone density. Dual X-ray absorptiometry (DXA          scan) will be performed to evaluate for low bone density and a blood test will be          performed to evaluate for low sex hormones, low levels of vitamin D, and other risk          factors for low bone density.   "
89967|NCT02108483|"     This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic     reaction following irradiation of the skin under controlled conditions.   "
89968|NCT02108470|"     The aim of this study is to determine whether by incorporating an OHRQoL measure in dental     practice will improve patient-dentist communication and enhance patient's satisfaction. The     objective of this study is to evaluate and compare how useful a standardized OHRQoL     assessment improves patient-dentist communication with regards to number of relevant OHRQoL     issues addressed and percentage of most frequently items discussed between the intervention     and control groups, assess the patient's active participation between the intervention and     control groups and enhances patient's satisfaction between the intervention and control     groups.   "
89969|NCT02108457|"     The purpose of this study is to determine the effect of specific bone marrow maps developed     with18F-FLT PET/CT imaging on the ability to spare proliferating bone marrow using proton     beam radiotherapy compared to IMRT. Participants will be 18 years of age or old with a     history of gynecologic cancer. Subjects will undergo 3 FLT-PET scans (one before treatment,     one during the course of RT, and one 2-5 weeks after initiation of RT). Scans will take place     in the Department of Radiation Oncology.   "
89970|NCT02108444|"     This study is a retrospective analysis to explore the incidence of hepatitis B virus     reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of     chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus     infection.   "
89971|NCT02108431|"     The purpose of the study is to determine, whether the urinary diversion via suprapubic     cystostomy compared to transurethral catheterization after robot-assisted radical     prostatectomy superior the postoperative patient comfort and reduce the postoperative     bacteriuria.   "
89972|NCT02108418|"     1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as          a new capsule formulation and as the original formulation of oral solution, after a          single oral dose of 400 mg under fed condition in healthy volunteers.        2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers.        3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian          volunteers.   "
90290|NCT02104245|"     This study (ARD-3150-1201, ORBIT-4) will evaluate the safety and efficacy of inhaled     Pulmaquin compared to inhaled placebo in subjects who have a confirmed diagnosis of     non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and     chronic P. aeruginosa infections.   "
90291|NCT02104232|"     Background The rates of perinatal depression in South Asian women are reported to be amongst     the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In     addition to its profound impact on women's health, disability and functioning, perinatal     depression is associated with poor child health outcomes such as pre-term birth, infant     under-nutrition and stunting. There is robust evidence that perinatal depression can be     effectively managed with psychological treatments delivered by non-specialist health care     workers. The Thinking Healthy Program (THP), a psychological treatment delivered by community     health workers (CHWs) in Pakistan, more than halved the rate of perinatal depression among     mothers and led to significant improvements in child health outcomes. To enhance access to     such evidence-based psychological treatments there is a need to examine the potential role of     other human resources such as lay persons in delivering psychological treatments such as THP     in poor resource settings.      Objective To evaluate the effectiveness and cost-effectiveness of THP delivered by peers (the     Thinking Healthy Program-Peer delivered in Goa, India; THPP-I) over the duration of 6 months.     Peers will be healthy mothers who live in the same community as potential trial participants     (TPs).      Study design and outcomes Individual randomized controlled trial in Goa, India involving 280     women. TPs will not be blinded to treatment allocation. Mothers attending antenatal clinics     at hospitals will be assessed for eligibility to participate in the trial (e.g. whether they     are in the second or third trimester of pregnancy). Those who are eligible will be invited to     participate in screening for depression; mothers who consent will be screened for depression     with a locally validated version of the Patient Health Questionnaire (PHQ-9). Women who     screen positive (PHQ-9 score ≥ 10) and give informed consent for further participation in the     trial will be randomly allocated in a 1:1 ratio to receive enhanced usual care (EUC) or     THPP-I+EUC, using a computer generated allocation sequence. The primary outcomes will be     remission (i.e. recovery from depression and depressive symptoms), both assessed by the PHQ-9     at 6 months. Secondary outcomes are depressive symptoms and remission at 3 months (PHQ-9),     maternal disability at 3 and 6 months (measured with the WHO-DAS), perceived social support,     breastfeeding rates and infant weight and height of children at 3 and 6 months. Outcomes will     be analyzed on an intention to treat basis.      Interventions EUC will comprise communicating the results of the screening to the mother     through an information sheet on self-care for mental health, communicating the results to the     mother's gynaecologist, providing the gynaecologist with the WHO mhGAP guidelines for the     treatment of depression, and providing guidance on referral of depressed mothers to mental     health services. TPs who are in the THPP-I group will receive, in addition to EUC, between 6     to 14 sessions of THPP starting from their recruitment in the second/ third trimester until     up to 6 months after child birth. Sessions will be delivered by peers on an individual basis     at a location of convenience to the TPs (usually at their own homes).      Implications THPP-I has the potential to advance knowledge of the extent to which     task-shifting of the delivery of evidence-based psychological treatments can be extended to     peers in the community. If effectiveness is observed, this approach offers a potential     opportunity to access a vast untapped human resource for maternal mental health care and     addresses a major barrier in global mental health - the lack of skilled and motivated human     resources in the formal health sector - offering a new avenue for the scaling up of     evidence-based psychological treatments and mental health services in low resourced settings.   "
89973|NCT02108405|"     A total of ninety - five patients (54men and 41women) were included in the study. Fifty-eight     patients developed septic complication during ICU stay (sepsis group). Forty seven patients     were critically ill without evidence of infectious organism (SIRS group). At admission,     Patients data include clinical status; SOFA score; central venous pressure; laboratory     analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The     attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long     as their stay in ICU. Memory B cells and Heinz bodies were monitored.   "
89974|NCT02108392|"     Pseudoxanthoma elasticum (PXE) is a rare multisystem disorder of autosomal recessive     inheritance (OMIM# 264800) and an estimated prevalence between 1:25.000 and 1:100.000. PXE is     characterized by calcification and fragmentation of connective tissue rich in elastic fibers.     Due to its high content of elastic fibers, Bruch Membrane in eyes of patients affected by PXE     becomes thickened and calcified. The ocular phenotype is characterized by angioid streaks and     peau d'orange but also choroidal neovascularizations and chorioretinal atrophy thereby in     part mimicking the phenotype of age-related macular degeneration. The disease is due to     mutations of the ABCC6-gene coding for a transmembrane protein which is mainly expressed in     the liver and kidney. It is hypothesized that ABCC6 is involved in the excretion of a yet     unknown factor from the liver which inhibits systemic calcification. In animal models several     candidates for this factor have been identified but direct evidence for such a factor in     patients with PXE is still missing. The primary purpose of this study is to further     investigate the ocular phenotype of patients with PXE using multimodal imaging and functional     testing to delineate the impact of Bruch membrane pathology on the eye. Furthermore, possible     systemic anti-calcification factors, as well as associations with the vascular alterations     are investigated to gain more insights into the pathogenesis of PXE..   "
89975|NCT02108379|"     This study will investigate usability and compliance related to rhinix nasal filters for the     treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in     Denmark.   "
89976|NCT02108366|"     Each year, influenza A infection caused great mortality and morbidity, especially among the     elderly and individuals with chronic illness. Many of these patients are 'late presenters'     who are admitted to hospital a few days after symptoms onset and have developed complications     secondary to immunodysregulation. Antiviral treatment with the neuraminidase inhibitor is of     limited usage for patients who presented to the hospital 48 hours after symptom onset. Apart     from ventilatory and extracorporeal membrane oxygenation support, treatment options for these     patients are limited. Recent animal study has demonstrated that combinations of an antiviral     agent with a COX-II inhibitor can reduce mortality in mice infected with influenza virus. The     investigators therefore propose to enrol patients with severe influenza A infection requiring     hospitalization and oxygen support on a randomized controlled trial with celecoxib.   "
89977|NCT02108353|"     EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of     EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian     rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks of     intervention will be followed by 12 weeks of washing out.   "
89978|NCT02108340|"     This study will evaluate the use of microwave radiometry in a population of patients     diagnosed with acute appendicitis and treated with appendectomy. The main purpose of the     study is to report the results of microwave radiometry as a diagnostic tool in acute     appendicitis and compare those results with the commonly used ultrasonography.   "
89979|NCT02108327|"     Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee     Arthroplasty (TKA).   "
89980|NCT02108314|"     Breast cancer is the leading female cancer in Singapore, but 3 in 5 women are not going for     their regular mammography screenings at recommended frequencies despite 15 years of     nationwide efforts by Breast Screen Singapore. The investigators aim to determine the     efficacy of opportunistic health promotion for uptake of mammography screening in Singaporean     women attending private sector primary care clinics in Singapore by implementing a simple and     feasible questionnaire to identify potential candidates for mammography screening, coupled     with recommendations by the primary care provider and a directed promotional video produced     by Kandang Kerbau Hospital (KKH) that is aimed at addressing some of the barriers to     screening.   "
89981|NCT02108301|"     The aim of the present trial is to evaluate whether the conversion of immunosuppression from     tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters     of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal     transplant recipients.   "
89982|NCT02108288|"     OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost     ophthalmic solution are administered once daily for 7 days and the effect on the blood     concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating     the combination drug will be determined.   "
89983|NCT02107222|"     A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump Assisted     Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction with     Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in Patients     with COPD Exacerbation and Respiratory Failure   "
89984|NCT02107209|"     The clinical utility of bronchoscopic methods for achieving lung volume reduction has been     evaluated in patients with advanced emphysema because these procedures are uniformly safer     than surgical volume reduction. These include one-way valves, or bronchial occlusive devices     to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to     improve expiratory flow, wire coils implants that compress the airway and thermal vapor     ablation that causes an acute injury with subsequent fibrosis and reductions in volume.   "
89985|NCT02107196|"     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial     aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as     compared to placebo in women with IBS-D over a 12-week treatment period.   "
89986|NCT02107183|"     The purpose of this study is to determine whether, as compared with the Venturi mask, a     nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in     patients needing oxygen therapy after extubation.   "
89987|NCT02107170|"     Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis     obliterans of lower extremities are two kinds of common surgeries in the investigators'     hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive     function, are not clear. In this study investigators propose to measure postoperative     cognitive function and other outcome of patients who are undergoing these two kinds of     surgeries, and try to identify whether there is an association between different kinds of     anesthetics and postoperative outcome. Investigators will also observe whether changes in     plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative     delirium or cognitive change.   "
89988|NCT02107157|"     The purpose of this study is to assess treatment of facial rejuvenation using the standard     hand piece and a Lens Array for the 755nm Alexandrite laser.   "
89989|NCT02107144|"     The study should enrol 50 patients with stable coronary artery disease scheduled for elective     percutaneous coronary intervention of single, de novo lesion of native coronary artery.     Patients will be randomized to orally given trimetazidine on top of standard medical therapy     for stable coronary artery disease versus standard therapy only. The randomization will begin     48 hrs before intervention. Index of microcirculatory resistance (IMR) will be measured by     thermodilution method using coronary pressure and temperature wire before and after stent     implantation. Echocardiography will be performed before intervention and within 30 minutes     after intervention. Patients will be followed clinically for a period of one year.   "
89990|NCT02108262|"     This is a multicenter randomized, double-blind, placebo-controlled, parallel-group,     dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of     multiple dose administration of two dose levels of CSL112 compared with placebo in subjects     with acute myocardial infarction (AMI).   "
89991|NCT02108249|"     The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of     the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar     spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with     commercially available pedicle screw fixation systems in order to extend existing pedicle     screw constructs. Subjects will be evaluated over a 2 year period and compared to historical     control.   "
89992|NCT02108236|"     To determine the efficacy and safety of acupuncture for obesity and overweight people in     China.   "
89993|NCT02108223|"     The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who     had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH     (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The     investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the     control groups regarding the results of IVF in these patients.   "
89994|NCT02108210|"     Rationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no     somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine     network has been suspected to play a role in the pathophysiology of CFS. Although     derangements of the cytokine network in CFS are controversial, a major problem is that many     studies did not use adequate controls. In addition, all studies have been performed on     peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the     brain, the information that can be derived from peripheral blood cells is limited. The only     information regarding the possible role of cytokines in the pathophysiology of CFS could come     from intervention studies in which pathogenetically important cytokines are inhibited. A     potentially relevant cytokine which can be blocked in humans without severe side effects is     IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited     evidence for this.      Objective: To investigate the effect on symptomatology of interference with IL-1 in CFS     patients.      Study design: A randomized placebo controlled study will be performed to determine whether     interference with IL-1 is able to reduce fatigue and disabilities in CFS patients.      Study population: Female CFS patients without psychiatric co-morbidity will be included in     this study. Patients of the outpatient clinic of the Department of General internal medicine     and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study.     Patients will be asked to bring a healthy neighbourhood control to their first study visit.      Intervention: After inclusion patients will be randomized to receive one of the following     treatments:        -  interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);        -  placebo for 4 weeks (N=25).      Main study parameters/endpoints: The primary outcome measure will be fatigue severity     measured with the Checklist Individual Strength (CIS) at 4 weeks, measurement will be     repeated up to 26 weeks.      Secondary outcome measures will be:        -  level of functional impairment measured with the Sickness Impact Profile (SIP8) total          score;        -  physical and social functioning assessed with the subscale physical functioning and          social functioning of the SF-36;        -  level of psychological distress assessed with the total score on the Symptom          Checklist-90 (SCL-90);        -  pain severity assessed with a Visual Analog Scale (VAS);        -  cytokine measurement in blood (plasma and blood in Pax-gene tubes) and saliva (at          protein and mRNA level);        -  cortisol measurement in saliva and hair;        -  microbiome determination in faeces;        -  body temperature and pulse rate.   "
89995|NCT02108197|"     The investigators hypothesize that pregnant women with gestational diabetes will have a high     incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose     control in these women.   "
89996|NCT02108184|"     Comparison of the eradications rates of sequential therapy versus concomitant therapy of     treatment of Helicobacter pylori infection in Korea.      single center, randomized trial        1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg)          twice for 10 days        2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg)          twice for 14 days        3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole          40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days        4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole          40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days      1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol)     2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance   "
89997|NCT02108171|"     Most patients with preoperative varying degrees of stress, anxiety, which makes the stress     response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic     system hyperexcitability prone to cause adverse cardiovascular events and affect     postoperative recovery. However, phenobarbital, as the traditional premedication, has less     sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of     respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on.     Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative,     anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal     stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore,     dexmedetomidine as premedication has certain advantages. The purpose of this research is to     study sedative effect, safety and the impact of anesthesia recovery period of intranasal     dexmedetomidine premedication for suspension laryngoscopy.   "
89998|NCT02108158|"     A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of     different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.   "
89999|NCT02108145|"     Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common     hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was     presented in the area of the biliary duct bifurcation. Recent retrospective study included     heterogeneous group of malignant diseases demonstrate that draining more than 50% of was     associated with a longer median survival.      However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting     clinical guideline and Asia-Pacific consensus recommendations for endoscopic and     interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment     bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to     the absence of randomized controlled trials.   "
90000|NCT02108132|"     Hemophilia is caused by a single-gene defect resulting in familial bleeding disorder. Small     increase in gene products could transform a severe form of hemophilia into a mild one. Stem     cells from extrahepatic sources are being considered for clinical applications in liver cell     therapy as they possess high in vitro culture potential and could be used in transplant     procedures. We studied the differentiation of bone marrow hematopoietic stem cells (BM-HSCs)     from hemophilia patients' relatives into factor 8 (FVIII)-producing hepatocyte-like cells     aiming to expand patients' donor options for partial replacement of mutant liver cells by     healthy cells in hemophilia A patients which could manage the severity of the bleeding     disorder.      BM-HSCs from hemophilic families will be cultured in short-liquid hepatic induction medium.     Appearance of hepatic phenotype will be evaluated by alpha-fetoprotein expression using     immunocytochemistry. Functional evaluation of transdifferentiation will be done through     detection of albumin synthesis using microalbumin assay kit, factor VIII activity by     one-stage clotting assay and expression of FVIII messenger RNA( mRNA) by reverse     transcription ( RT-PCR).      Inducing the differentiation of BM-HSCs by in-vitro manipulation may become a valuable tool     to provide a cell source for hepatocyte transplant procedures for treatment of hemophilia     patients.   "
90001|NCT02108119|"     To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.   "
90002|NCT02108106|"     This is a dose escalation study that will be conducted in healthy volunteers. Multiple     cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and     tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of     AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the     blood.   "
90003|NCT02108093|"     The effect of retrograde autologous priming (RAP) on regional cerebral oxygenation (rSO2)     still remains unclear, because studies are limited in sample size and study design, and     because of the absence of prospective studies. The investigators hypothesize that RAP limits     the degree of hemodilution and thereby limits prolonged intraoperative cerebral desaturation     during cardiopulmonary bypass (CPB), compared to the conventional priming method.      The primary objective of this study is to determine whether RAP limits the degree of     hemodilution and limits prolonged intraoperative cerebral desaturation during cardiopulmonary     bypass, compared to the conventional priming method. Prolonged intraoperative cerebral     desaturation will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 > 3000     is associated with increased risk of cognitive decline. The investigators hypothesize that     RAP limits the degree of hemodilution and thereby limits the incidence of rSO2 desaturation     score50 > 3000 with a relative difference of 50%.      The subjects who are divided in the RAP group, the retrograde autologous priming technique     will be used, where the patient's own circulating blood partially will be replaced by the     priming solution in the cardiopulmonary bypass. In the Control group the conventional priming     method will be used. The main study parameters is rSO2 desaturation score50.   "
90004|NCT02108080|"     Background:      - People with alcoholism have differences in their brains compared with healthy people.     People who are dependent on alcohol also perform differently on behavioral tasks. Researchers     want to find out more about these differences. They also want to see if these differences are     related to DNA.      Objective:      - To see if differences in brain structure relate to personality and behavior differences in     people with and without alcohol dependence.      Eligibility:      - Adults age 18 and older.      Design:        -  Participants will visit the NIH Clinical Center once during the study.        -  Participants will be screened with a medical history, EKG, and physical exam. They will          give blood and urine samples and undergo a psychiatric interview.        -  Participants will be asked about their alcohol drinking, to see if they have an alcohol          use disorder.        -  Participants will play three computerized games. Some will play these games inside a          magnetic resonance imaging (MRI) scanner.        -  MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie          on a table that slides in and out of a cylinder. They will be in the scanner for about          90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud          knocking noises. They will get earplugs.   "
90005|NCT02108054|"     Background:      - Scientists know that alcohol use disorders affect brain structure. They want to know more     about the effects of alcohol use disorders on a person s behavior. They want to develop tasks     that can be done inside a scanner that can help them better understand these effects in later     studies.      Objective:      - To develop tasks that investigate a person s behavior that can be used in later studies.      Eligibility:        -  Inpatient participants of another study. They must be physically healthy right-handed          adults 18 60 years old.        -  Healthy right-handed volunteers 18 60 years old.      Design:        -  Participants will be screened with medical history and physical exam. They will have an          EKG to record heart activity. They will give blood and urine samples and have a          psychiatric interview.        -  Participants will have between one and three visits.        -  Participants will be asked about their alcohol drinking to see if they have an alcohol          use disorder.        -  Participants will complete one of three simple computerized tasks either inside the          magnetic resonance imagining (MRI) scanner or outside of it.        -  The MRI scanner takes pictures of the brain. The scanner is a metal cylinder.          Participants lie on a table that can slide in and out of the cylinder. They will be in          the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The          scanner makes loud knocking noises, but they will get earplugs.   "
90292|NCT02104219|"     The purpose of this study is to characterize the natural history of HPP in patients with     Juvenile-onset HPP.   "
90006|NCT02108041|"     Background:      -How people respond to drugs depends in part on their genes. For some drugs, doctors can use     an individuals genetic background to help in dosing the drug. Researchers want to know how     doctors incorporate personalized or genomic medicine into clinical practice.      Objective:      -To study how physicians make personalized treatment decisions      Eligibility:      -Healthy adult primary care physicians who are internal (or family) medicine residents.      Design:        -  Participants will complete a screening form.        -  Participants will put on a headset, called a head-mounted display, showing a virtual          reality environment.        -  The environment will contain an exam room and the virtual patient.        -  After interacting with the virtual patient, participants will complete a series of          survey measures.        -  Participation will last for about 60 minutes. The virtual patient interaction and          follow-up questions will be audio taped.   "
90007|NCT02108028|"     Background:      - There are very few documents to help young adults living with advanced cancer discuss their     concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults     to explain what kind of care they would want if they became unable to communicate or make     medical decisions on their own. Researchers want to study if this document is helpful.      Objective:      - To study if Voicing My CHOiCES can reduce anxiety, improve sense of support, and improve     communication about advanced care planning.      Eligibility:      - Adults 18 to 39 years old being treated for cancer.      Design:        -  Participants will answer questions about their age, gender, employment, religion,          health, and marital status. They will also complete several brief questionnaires:             1. General Anxiety Short Form             2. Peace, Equanimity and Acceptance in the Cancer Experience             3. Functional Assessment of Social Support             4. Quality of Communication             5. Prior Communication about Advanced Care Planning        -  Then a health care professional will introduce Voicing My CHOiCES . Participants will          review the document and comment on parts they find relevant. They will also say if any          important items are missing. Participants will complete 3 pages of the document with the          assistance of a health care provider. They will be asked for positive and negative          observations.        -  The second stage of the study will take place about 1 month later. Participants will          repeat the brief questionnaires listed above. They will be asked if they shared any of          the preferences they described when completing the 3 pages of Voicing My CHOiCES during          visit 1 with a family member, friend, or health care provider. Research staff will ask          the participant for permission to contact the people they spoke with in order to learn          whether their conversations about the document were helpful. They will ask for feedback          on how to make Voicing My CHOiCES more helpful.   "
90008|NCT02108015|"     Objective      Ionotropic glutamate receptors are ligand-gated ion channels responsible for most of the     excitatory neurotransmission in the mammalian central nervous system (CNS). Based on     pharmacology, they have been grouped into three subtypes-NMDA, AMPA and kainate. In recent     years it has become apparent that the receptors do not function alone, but in the company of     auxiliary proteins that regulate their activity [1]. Some of these have been shown to     modulate AMPA receptor trafficking, gating and pharmacology and are classified as     transmembrane AMPA receptor regulatory proteins, or TARPs ( >=-2, >=-3, >=-4, >=-5, >=-7, and     >=-8). Genetic data indicate a possible role of TARPs in schizophrenia, depression, epilepsy,     neuropathic pain, and bipolar disorder [1]. In a preclinical collaboration with Eli Lilly, we     developed a promising radioligand, 18F-TARP252 to image TARP >=-8 using positron emission     tomography (PET).      This protocol covers three phases:        -  Phase 1: kinetic brain imaging to quantify TARP >=-8 in brain relative to concurrent          measurement of the parent radioligand in arterial plasma;        -  Phase 2: if 18F-TARP252 is successful in Phase 1, we will estimate the          radiation-absorbed doses by performing whole body imaging;        -  Phase 3: test-retest analysis of brain binding relative to concurrent measurement of the          parent radioligand in arterial plasma.      Study Population      Healthy adult female and male volunteers (n=22, ages 18 - 55) will undergo brain imaging. An     additional eight healthy volunteers will undergo whole body dosimetry analysis.      Design      For quantification of TARP >=-8, 22 healthy controls will have brain PET imaging using     18F-TARP252 and an arterial line. Some of them will have a test-retest scan. Eight additional     subjects will have a whole body PET scan for dosimetry. For dosimetry, no arterial line will     be used.      Outcome Measures      To assess quantitation of TARP >=-8 with 18F-TARP252, we will primarily use two outcome     measures: the identifiability and time stability of distribution volume calculated with     compartmental modeling. In test-retest study, we will calculate the retest variability. We     will assess whole-body biodistribution and dosimetry of 18F-TARP252 by calculating doses to     organs and effective dose to the body.   "
90009|NCT02108002|"     Background:      - Von Hippel-Lindau (VHL) disease is a rare gene disease. People with VHL often have a brain     tumor called hemangioblastoma. Standard treatment for these tumors is risky surgery.     Researchers want to find new ways to treat people who have the tumors. They want to see if a     drug that fights other cancers might slow the growth of hemangioblastomas in some people with     VHL. Some people with VHL have mutations that make abnormal proteins. Tumors form in such     people because the abnormal protein is broken down quickly. The cancer drug may work in these     tumors by preventing breakdown of protein.      Objective:      - To study how the drug vorinostat affects hemangioblastomas in people with VHL.      Eligibility:      - Adults at least 18 old with hemangioblastomas from VHL.      Design:        -  Participants must already be in study 03-N-0164. They must have tumor surgery scheduled.        -  Participants must stop taking most medications 14 days before surgery.        -  One week before surgery, participants will enter the hospital. They will be screened          with medical history and physical and neurological exams. They will give blood and urine          samples. Participants will have an electrocardiogram. For this test, small sticky          patches are put on the arms, legs, and chest. Participants will lie still for a few          minutes while a machine records heart rate and rhythm.        -  Participants will take one vorinostat by mouth each day for 7 days.        -  Participants will have blood drawn during the week to check for any side effects.        -  Participants will have their tumor removed in surgery. Researchers will study the tumor          tissue for the effects of the study drug.        -  A nurse will call participants 1 month after surgery to check for side effects.   "
90010|NCT02107989|"     Objectives:      The overall study objective is to compare the sensitivities and specificities of morphometric     analysis techniques using structural MRI images based on pre- and postsurgical localization     of epileptic foci in patients undergoing presurgical evaluation for medically refractory     epilepsy. To carry out these analyses, we aim to establish an age-stratified normative     imaging database using healthy volunteers. Additional objectives are to identify abnormal     networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and     memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive     function and the networks associated with these functions.      Study population:      150 adults and children (age 8-65) with uncontrolled focal epilepsy, and 100 age-stratified     healthy volunteers.      Design: A retrospective and prospective natural history study. Research procedures for     patients in this study include neuropsychological testing and 1-4 MRI sessions during     presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing     approximately 12 months post-operatively. Research testing (such as research     neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical     testing whenever possible, likely reducing the number of required visits. Patients will also     have optional MEG and 7T structural imaging. Data will also be obtained from patients who     have already undergone epilepsy surgery if they had procedures as outlined in the protocol     and are willing to share the data. Healthy volunteers will receive a subset of the     pre-operative procedures for patients, requiring at least 3 visits. In order to ensure     adequate data acquisition, subjects may be re-scanned up to three times for the portions of     the study in which they participated, possibly requiring additional visits.      Outcome measures:      The main outcomes will be establishment of normative values for morphometric analysis methods     in age-stratified normal controls, and comparison of the sensitivity and specificity of these     measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome     measures will include determination of the sensitivity and specificity of source localization     using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest,     as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the     effects of epileptogenic zones and surgery on cognitive function and the networks underlying     these functions.   "
90293|NCT02104193|"     The purpose of the study is to evaluate the effect of simvastatin in combination with     radiotherapy on the clinical outcomes of patients with brain metastases.   "
90011|NCT02107976|"     Diabetes type two is a debilitating disease that leads to chronic morbidity such as     accelerated microvascular disease. Accelerated microvascular disease may produce blindness,     end stage renal disease, myocardial infarction, stroke, and limb ischemia. Strategies to     prevent or delay microvascular disease have the potential to improve the lives of millions     and prevent catastrophic illness. The major focus of prevention of microvascular disease in     diabetes has been on the endothelium and its role in protection of blood vessels. An     unexpected means to prevent microvascular disease in diabetes may be coupled to the function     of vitamin C in red blood cells (RBCs) of diabetic subjects. Based on new and emerging data,     vitamin C concentrations in RBCs may be inversely related to glucose concentrations found in     diabetes. Based on animal data, we hypothesize that RBCs with low vitamin C levels may have     decreased deformability, leading to slower flow in capillaries and microvascular hypoxia, the     hallmark of diabetic microangiopathy. Low vitamin C concentrations in RBCs of diabetic     subjects may be able to be increased, by using vitamin C supplements. Findings in animals may     not accurately reflect effects in humans because of species differences in mechanisms of     vitamin C entry into RBCs. Therefore, clinical research is essential to characterize vitamin     C physiology in RBCs of diabetic subjects. In this protocol we will investigate physiology of     vitamin C in RBCs of diabetic subjects as a function of glycemia, with and without vitamin C     supplementation. We will screen type II diabetic subjects on insulin and select those with     low vitamin C levels and hemoglobin A1C concentrations of 8-12%. Selected subjects will be     hospitalized twice, each time for approximately one week. As inpatients, subjects will have     two venous sampling periods each of approximately 24 hours. For the first sampling period,     controlled hyperglycemia will be induced by withdrawing insulin and providing a high     carbohydrate load diet (70-75% carbohydrate). Hyperglycemia will not exceed 9 hours, and will     be reversed by reinstituting insulin. The second sampling period, also for 24 hours, will be     performed under conditions of euglycemic control.      During the two sampling periods, samples will be withdrawn via venous catheter for RBC     deformability and vitamin C concentrations. At discharge, subjects will be placed on a     vitamin C supplement and seen as outpatients at weekly intervals. After 3 or 6 weeks     (depending on RBC vitamin C levels), subjects will be hospitalized again, and sampling     repeated as described. In this manner, each subject serves as his/her own control, and     deformability of red blood cells can be determined in relation to glycemia and to vitamin C     concentrations in RBCs and plasma.   "
90012|NCT02107963|"     Background      GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on     osteosarcomas and some other sarcomas. T cells expressing 1st generation anti-GD2 chimeric     antigen receptors (CARs) were safe and mediated modest antitumor activity in some patients     with refractory neuroblastoma.      A 3rd generation anti-GD2-CAR (GD2-CAR.OX40.28.z.ICD9) has been produced and holds promise     for increased activity compared to the 1st generation GD2-CAR already studied in clinical     trials. As an added safety measure, the vector includes a suicide switch comprising a caspase     dimerization domain (ICD9) that can be activated by a small molecule to induce death of the     genetically engineered cells if they were induce untoward toxicity.      Objectives      Primary:Determine the feasibility of producing anti GD2-CAR cells meeting the established     release criteria and to assess the safety of administering escalating doses of anti-GD2-CAR     engineered T cells in children and young adults with GD2+ solid tumors, including     neuroblastoma, following cyclophosphamide-based lymphodepletion.      Secondary:        1. Determine if administration anti-GD2-CAR engineered T cells mediate antitumor effects in          children and young adults with GD2+ solid tumors;        2. Measure persistence of adoptively transferred anti-GD2-CAR T cells and correlate this          with antitumor effects;        3. Extend information regarding the prevalence and intensity of GD2 expression in          non-neuroblastoma, non-osteosarcoma solid tumors in children and young adults;        4. If unacceptable toxicity occurs that is possibly, probably or likely related to          anti-GD2-CAR T cells, assess the capacity for AP1903, a dimerizing agent, to mediate          clearance of the genetically engineered cells and resolve toxicity; and        5. Assess toxicity of AP1903 if administered to mediate clearance of anti-GD2-CAR T cells.      Eligibility      Patients 1-35 years of age, at least 15 kg, with osteosarcoma or a GD2+ solid tumor     (including neuroblastoma) that has recurred after or not responded to standard therapy and is     deemed incurable by standard therapy.      Design      After apheresis to collect T cells for transduction, patients receive cyclophosphamide     1800mg/m(2)/d as a lymphodepleting regimen. A phase I cell dose escalation scheme will used     at 4 dose levels (1 x 10(5) transduced T cells/kg; 1 x 10(6) transduced T cells/kg; 3 x 10(6)     transduced T cells/kg; and 1 x 10(7) transduced T cells/kg), using a standard 3 plus 3 dose     escalation design. An expanded group of a total of 12 patients will be treated at the highest     dose, comprising at least 6 osteosarcoma patients.      Patients will be monitored for toxicity, antitumor effects and persistence of anti-GD2-CAR T     cells.      Patients with a PR, SD may receive a 2nd cycle at the next higher dose level a minimum of 60     days following completion of the first cycle if eligibility criteria are met.      A maximum of 36 patients may be treated on this study. Given that there is likelihood that     some patients with non-osteosarcoma will not meet the criteria for GD2 expression to be     eligible for enrollment, up to 72 subjects will be screened to enroll a maximum of 36     patients for treatment. Up to 2-3 patients will be accrued per month, and therefore this     study may require up to 2-3 years to complete enrollment and treatment.   "
90013|NCT02107950|"     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy     (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of     progression free survival (PFS).   "
90014|NCT02107937|"     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy     (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of     progression free survival (PFS).   "
90015|NCT02107924|"     The purpose of the study is to gather information on the use of Stimulan, the surgery, and     anitbiotics to whetether the APPI has decreased or shown improvement when compared to study     participants who did not receive Stimulan during their revision total knee replacement     surgery.   "
90016|NCT02107911|"     The potential participants will be informed of the study details, including the study     objectives. Once they have read the study information sheet and have a good understanding of     the study, those who intend to participate in the study will be asked to sign the consent     form for this study. There are 2 groups of participants: MSM who seek HIV voluntary     counseling and testing service (phase I) and MSM who meet nPEP criteria (phase II).   "
90017|NCT02107898|"     Primary Objective:      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as     add-on therapy to stable daily statin therapy with or without other lipid modifying therapy     in comparison with placebo after 24 weeks of treatment in heterozygous familial     hypercholesterolemia (HeFH) or high cardiovascular risk participants with     hypercholesterolemia.      Secondary Objectives:        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks          of treatment.        -  To evaluate the effect of alirocumab on other lipid parameters.        -  To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after          52 weeks of treatment.        -  To evaluate the safety and tolerability of alirocumab.        -  To evaluate the development of anti-alirocumab antibodies.        -  To evaluate the pharmacokinetics of alirocumab.   "
90018|NCT02107885|"     This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is     hypothesised that single oral doses of DS-1971a within the planned dose range will be safe     and well tolerated by healthy male subjects.   "
90019|NCT02107872|"     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose     study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and     pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.   "
90020|NCT02107859|"     This is a Phase 3, multicenter, open-label, safety and efficacy study of ataluren in patients     with nonsense mutation cystic fibrosis who participated in the previous Phase 3 study with     ataluren (PTC124-GD-009-CF; Study 009).   "
90021|NCT02107846|"     This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and     pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement therapy.     The dose levels of PRX-112 are 50 units, 100 units, 200 units and 400 units GCD. Subjects     will receive once daily oral administrations of PRX-112 for 5 consecutive days at each dose     level with a 2-day washout period between doses.   "
90294|NCT02104180|"     Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with     removal of wound dressing during care of venous leg ulcer   "
90022|NCT02107833|"     : This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in     healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be     randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106     doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein.     Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days.     Subjects will remain at the clinical center for 24 hours after the first administration (Day     1) of OPRX-106 including PK sampling and then return to the site daily for additional     administrations and study procedures.   "
90023|NCT02107820|"     Overactive Bladder (OAB) is a chronic condition defined as urgency with or without     incontinence usually associated with frequency and nocturia. It is a common condition     affecting 15-45% of adults and constitutes a significant proportion of patients attending     urogynaecology clinics. OAB is known to have a significant impact on the physical, social and     emotional quality of life and sexual function in women. The treatment of OAB is initially     conservative with bladder training followed by pharmacotherapy.      Evidence from a recent Cochrane review on treatment of OAB suggests that the efficacy of     anticholinergics in treatment of OAB is enhanced when combined with BT. Women who fail to     improve with these initial measures are offered Intravesical Botox or neuromodulation in the     form of Percutaneous Tibial Nerve Stimulation (PTNS) or Sacral Nerve Stimulation (SNS).      PTNS has also been shown to more effective than pharmacotherapy with anticholinergics. In     2010 National Institute of Clinical Excellences (NICE) issued guidance stating 'PTNS for OAB     demonstrates effectiveness without major safety concerns      We hypothesise that the outcome of PTNS will improve if the PTNS sessions are combined with     bladder training (BT).   "
90024|NCT02107807|"     Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18     through 60 years of age) and elderly (≥61 years of age) subjects with and without     immunosuppressive conditions.   "
90025|NCT02107794|"     The investigators' decision aid for patients with GD, GD Choice, will be the result of a     user-centered participatory action research involving) synthesis of the best available     evidence from the literature and real-world registry experience, ii) input and involvement of     patients, clinicians and other stakeholders, iii) direct observation of encounters and iv)     extensive field-testing. The goal is to create a decision aid that will be rigorously     evidence-based, clear and complete, able to be used by clinicians with minimal training time,     while satisfying extant standards for rigorous high-quality shared decision making tools.   "
90026|NCT02107781|"     The investigators will monitor the pressure generated inside the abdomen in a patient in whom     the surgeon, for whatever reason, felt that the abdomen could not be closed at the initial     operation. The investigators will aggressively treat rises in intra-abdominal pressure and     see what changes, if any are found when the abdomen finally is closed.   "
90027|NCT02107768|"     The purpose of this study was to investigate the effects of early intensive aerobic exercise     regarding aerobic capacity, gait and balance, Health Related Quality of Life and     participation.   "
90028|NCT02107755|"     This phase II trial studies the effectiveness of the combination of stereotactic radiation     therapy and ipilimumab in patients with metastatic melanoma that has spread to four or fewer     sites in the body (oligometastatic). Stereotactic radiation therapy is a type of external     beam radiation therapy that uses special equipment to position the patient and precisely give     a either a single large dose of radiation therapy to a tumor or several large doses of     radiation therapy to a tumor using precision and accuracy that is guided by onboard daily     imaging prior to radiation therapy. Monoclonal antibodies, such as ipilimumab, can block     tumor growth in different ways. Some monoclonal antibodies find tumor cells and help kill     them or carry tumor-killing substances to them. Giving stereotactic radiosurgery together     with ipilimumab may kill more tumor cells by causing addition melanoma antigens to be     presented to the immune system.   "
90029|NCT02107742|"     This study will investigate the influence of injection speed on pain during injection of     lidocaine. It is anticipated that a longer injection time will lead to less pain for the     patient during the injection. This hypothesis will be tested on healthy volunteers, who will     each receive three injections with the same amount of lidocaine subcutaneously on the     abdomen. The injections will be given over 15, 30 and 45 seconds. After each injection, the     subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). The aim of     the study is to find a simple method for pain reduction that can be used in clinical     practice.   "
90030|NCT02107729|"     This study will investigate the influence of needle gauge on pain during injection of local     anaesthetic. Healthy volunteers will be recruited, who will each receive three injections     with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the     participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is     anticipated that the pain will decrease with decreasing thickness of the needle. The aim of     this study is to find a simple method for pain reduction that can be used in clinical     practice.   "
90031|NCT02107716|"     This study will investigate the influence of adjusting the pH of lidocaine on pain during     subcutaneous injection. Each participant will receive two injections on the abdomen with     different pH. After each injection, the subject will be asked to evaluate the pain on a     Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing pH.     The aim of the study is to find a simple method for pain reduction that can be used in     clinical practice.   "
90032|NCT02107703|"     The main purpose of this study is to compare progression-free survival for women with hormone     receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced     breast cancer receiving either abemaciclib+fulvestrant or fulvestrant alone. Participants     will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9     months for each participant.   "
90033|NCT02107690|"     This study will investigate the influence of lidocaine temperature on pain during injection     of lidocaine. Each participant will receive three injections subcutaneously on the abdomen     with different temperatures. After each injection, participants will be asked to evaluate the     pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with     increasing temperature. The aim of the study is to find a simple method for pain reduction     that can be used in clinical practice.   "
90034|NCT02107677|"     This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests     (e.g. PCR or viral culture) for dengue diagnosis in the US.      DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages     of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This     test is intended to be used on sera obtained within the first 7 days of symptoms. DENV     Detect™ NS1 ELISA and rapid test results (positive or negative) must be confirmed by testing     with a reference standard test.      This study will use archived, leftover human serum samples that have been sequentially     collected from areas non-endemic for Dengue infection. Each specimen must have been collected     within the first 7 days of symptoms, and must be accompanied by clinical data demonstrating     that the individual had symptoms consistent with Dengue infection. The samples will have no     personally identifiable information.      ELISAs and reference tests will be performed by different operators who are laboratory staff     members. These staff members, blinded to each other's results, will evaluate the samples from     each method independently.   "
90035|NCT02107664|"     Radiation therapy (RT) is one of the primary treatments for bone cancer pain due to     metastatic cancer disease. About 6 of 10 patients obtain pain relief from RT. There are no     established predictors that can be used to select patients that respond to RT. This raises     the need to identify potential clinical characteristics and biomarkers that may better select     patients for RT. A similar argument can be stated for the development of cachexia; there are     currently no predictors that can identify patients who will develop cachexia later in the     cancer disease trajectory. Cancer symptoms can be related to inflammation. Both pain,     cachexia and depression are associated with inflammation in experimental and preclinical     studies . Still, the clinical data on the relationship between inflammation and pain or     cachexia are sparse. This is especially true for longitudinal follow-up studies.      This study will include 1000 adult patients in a multicenter, multinational longitudinal     observation study of patients who receive radiation therapy for bone cancer pain. Demographic     data, clinical variables, genetic biomarkers and inflammatory substances will be assessed     before start of RT. The primary analysis in the study is to identify potential predictors for     pain relief from RT. During follow up the study will also explore for predictors for     development of cachexia and which inflammatory substances that are associated with changes in     pain intensity, depression and development of cachexia.   "
90036|NCT02107651|"     Serious adverse events in patients treated with new oral anticoagulants are underreported.   "
90037|NCT02107638|"     Parkinson's disease (PD) is defined as a progressive disorder of the nervous system that     affects the patient's mobility, balance and cognition. Tremor, slowed movements, and rigidity     are physical symptoms which contribute to postural and gait abnormalities seen in many PD     patients. Other symptoms include loss of balance and restricted range of motion, increasing     the risk of falling. Osteopathic manipulative medicine (OMM) is a form of manual treatment     provided by osteopathic physicians. This form of treatment aims to help decrease muscle     spasms and improve joint range of motion and movement. We are proposing a pilot study to     investigate the impact of OMM on balance, motor function, and falling in PD patients. We are     also going to screen for serum biomarker changes to investigate the potential effects of OMM.     Our research team and institution have experience in providing osteopathic care and physical     rehabilitation for PD patients. In this study, balance and motor function will be evaluated     for each subject throughout the study period. We will also keep track of the number of falls.     Balance will be measured using Sensory Organization Test (SOT) and motor function will be     measured using Movement Disorder Society Unified Parkinson's Disease Rating Scale     (MDS-UPDRS). Both tools are non-invasive and clinically proven methods for measuring balance     and motor function.   "
90038|NCT02107625|"     The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-,     Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients     compared to traditionally dietary advice in IBS. The study also aim to investigate patients     compliance to either dietary advices. Further, the investigators aim to find out if IBS     patients with different symptoms are alleviated in different ways, to be able to     individualize the dietary advices to result in a more optimal symptom relief in each patient     in the future.   "
90039|NCT02107612|"     The purpose of this study was to evaluate the effect of a integrated system for inserting two     splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of     life of edentulous patients.   "
90040|NCT02107599|"     This study will evaluate whether the addition of quantitation as an adjunct to visual     interpretations significantly improves the accuracy of Amyvid scan interpretation.   "
90041|NCT02107586|"     The purpose of the study is to determine what the different outcomes are for biceps tenodesis     and tenotomy in the treatment of the long head of the biceps pathology.   "
90042|NCT02107573|"     The purpose of the study is to compare the differences in outcome between the traditional     rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression     surgery.   "
90043|NCT02107560|"     Cholangitis is a complication of biliary statsis. Bile juice is sterile when there is no     obstruction, however, it can be infected with bacteria when there is a stasis or obstruction.     After infection, cholangitis can be developed because of systematic endotoxemia or     bacteremia. Though identification of bacteria is very important for selection of adequate     antibiotics, treatment with empirical antibiotics is commonly performed when identification     of bacteria is not possible.      Identification of bacteria is usually done with blood or bile culture. In the previous     studies, the same results from blood and bile were common in patients with cholangitis.     However, the data of these studies were based on the bile juice which was aspirated by     surgery. Considering that bile duct obstruction is usually treated with endoscopy or     radiological intervention without surgery, it is necessary to collect data with endoscopic or     radiologic intervention. In addition, the concordant rate of these two tests has not been     reported according to severity of cholangitis. As a result, the necessities of bile and blood     culture are not agreed among experts in this fields.      Our hypothesis is that concordant rates of bile and blood culture are same in patients with     each moderate or severe cholangitis. However, the concordant rates of bile and blood culture     are different between patients with moderate and severe cholangitis. This study will assess     the positive rates of blood and bile culture in patients with moderate or severe cholangitis,     respectively and compare the results according to the different severity.   "
90047|NCT02107508|"     Obesity is increasing rapidly all over the world not only in adults but also among children.     As a modifiable component of total energy expenditure (TEE) ,the amount of energy expended     during physical activity plays an important role in preventing weight gain. Decreased     physical activity, coupled with an over-consumption of calories, lead to the change of body     composition by storing energy as fat.Although several studies have simultaneously examined     body composition with energy expenditure the independent roles of body composition with     activity energy expenditure (AEE) are less firmly established. It's suspected shrewdly that     energy expenditure is partly influenced by the body composition. The aim of the study is to     examine the relation of AEE with body composition in a population of school-age children.   "
90048|NCT02107495|"     To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in     intended use settings, by comparing test results of the A20 CHF Test with results obtained     from an FDA-cleared comparator assay.   "
90049|NCT02107482|"     The purpose of the study is to test the effect of a localized narrow band ultraviolet     (NB-UVB) phototherapy compared to visible light that does not produce UVB on the clearance of     psoriasis plaques and resolution of itching. Localized NB-UVB (Levia®) phototherapy device is     cleared by the U.S Food and Drug Administration (FDA).   "
90050|NCT02107469|"     The purpose of the study is to determine whether phyllanthus niruri and sida cordifolia are     effective in treatment of diabetic polyneuropathy compared to placebo. Also two different     administration forms (extract capsules and crude herbs) are used to find out whether there     are differences in efficiency and compliance.   "
90051|NCT02107456|"     Myofascial trigger point is one of the most common causes of musculoskeletal disorders.     Myofascial trigger point in upper trapezius has been reported as a symptom in patients with     neck and upper thoracic pain. The purpose of this study was to investigate the prolonged     effect of dry needling on myofascial trigger point in upper trapezius muscle.   "
90052|NCT02107443|"     This randomized clinical trial studies standardized geriatric assessment (GA) or usual care     in improving communication and quality of life in older patients with advanced solid tumors     or lymphoma and their caregivers. A GA measures the issues important to older patients,     including function, psychological status, cognitive abilities, social support, and the impact     of medical problems on quality of life. A GA may improve communication between patients and     their doctors in addressing patient concerns. It is not yet known whether a standardized GA     is more effective than usual care in improving communication and quality of life in older     patients with solid tumors or lymphoma.   "
90053|NCT02107430|"     The purpose of this study is to determine whether DCVAC/PCa added after radical primary     prostatectomy can improve PSA progression times within 5 years for patients with high risk     localized Prostate Cancer.   "
90054|NCT02107417|"     This study aims to investigate the effects of Transcutaneous Electrical Nerve Stimulation     (TENS) in reducing the symptoms of pain and numbness and improve the daily lives of cancer     patients who have Chemotherapy-induced peripheral neuropathy (CIPN).   "
90055|NCT02107404|"     The purpose of this study is to determine whether DCVAC/PCa added after radical primary     prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.   "
90056|NCT02107391|"     The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can     improve PSA progression times for patients with Metastatic Prostate Cancer.   "
90057|NCT02107378|"     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result     in prolongation of Overall Survival (OS).   "
90058|NCT02107365|"     Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients     infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard     treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination     with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment     in non-responders genotype 1-infected patients.      Given the absence of current solutions and urgent therapeutic needs for HCV genotype     4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study     aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir,     Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat     population.      60 subjects will be enrolled.      The primary endpoint will be the rate of sustained virological response (SVR), defined by an     undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).   "
90059|NCT02107352|"     The main aim of this research is to investigate whether the use of cognitive event-related     potentials is an interesting way to identify subgroups of alcoholic patients displaying     specific clinical symptoms and cognitive disturbances in order to help clinicians to adapt     the pharmaceutical approach to the specific needs of the patient.      Nowadays, a fundamental question remains: How can investigators identify among alcoholic     patients who are likely to benefit from the use of naltrexone, acamprosate or baclofen, and     those who are not? The goal of this application is to identify subgroups of alcoholic     patients displaying specific clinical symptoms and cognitive disturbances linked to     consistent biological markers. Investigators propose that this might help clinicians improve     their treatment of alcoholic patients by focusing therapy on individual cognitive     disturbances, and by adapting pharmaceutical approaches to the identified brain     pathophysiology. In other words, investigators suggest that specifying the cognitive profile     of each individual patient may help clinicians in their choice of a suitable drug program.      To reach this aim, investigators suggest that a joined investigation of early (P100) and late     (P300) brain event-related potentials (ERP) components may help create subgroups of alcoholic     patients with homogenous cognitive deficits, and that this ''classification'' might help     optimize drug treatment. More precisely, investigators suggest that relapse in chronic     alcoholism is partly due to (1) the preferential attentional allocation to alcohol-related     information (e.g. the sight of a bottle of wine). As the P100 component has already been     shown to be enhanced by motivationally relevant stimuli, investigators think that this     component is well-suited for this purpose; and (2) the impairment of the inhibitory control,     which is necessary to suppress an inappropriate prepotent response. The Go/No-Go task is a     simple procedure, which has already proven to be highly reliable to evidence a deficit in     inhibitory control processing in alcoholics, indexed by a No-Go P3 of decreased amplitude and     less anterior topography. In summary, investigators have two simple experimental procedures,     an oddball task and a Go/No-Go task, which can be easily carried out in clinical settings,     and which can provide interesting data concerning, respectively, the existence of an implicit     attentional bias towards alcohol-cues and the deficit of inhibitory control towards a     prepotent response, through the observation of well-known and well-described cognitive ERP     components, i.e. the P100 and P3b components. The main goal of this project will be to test     the effect of different drug medications on both attentional (P100) and inhibitory (P300)     deficits observable in alcoholic patients.   "
90129|NCT02106338|"     This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple     ascending dose study to evaluate the safety and tolerability of CRS3123, a methionyl-tRNA     synthetase inhibitor. In this study, doses of 200, 400, and 600 mg, or 100mg are planned and     will be given orally every 12 hours for 10 days. Up to 30 healthy male and female subjects 18     to 45 years, inclusive. The primary objective: of the study is to determine the safety and     tolerability of escalating doses of CRS3123 following oral administration of multiple doses     to healthy adults. The study duration is 46 weeks.   "
90060|NCT02107339|"     Patients undergoing major spinal surgery continue to experience moderate-to-severe pain     during the first 2-3 days following the operative procedure. Pain complicates the recovery     process, despite the routine practice of using potent opioid analgesics. The primary reason     that pain is poorly controlled in patients undergoing major surgery is that most     commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these     drugs results in periods of time when a patient will experience discomfort (at which time a     nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is     pressed to deliver more medication). The use of a long-acting opioid may be advantageous in     the perioperative setting. Methadone is an opioid that has a median duration of analgesia of     24-36 hours. Therefore, a single dose administered in the operating room may reduce the need     for pain medication and improve pain control for the first few postoperative days. The aim of     this randomized clinical trial is to examine the effect of methadone (compared to     hydromorphone) on postoperative pain management in patients undergoing major spine surgery   "
90061|NCT02107326|"     The purpose of this study is to evaluate the impact of a software for smartphones and tablets     on type 1 diabetes control and quality of life   "
90062|NCT02107313|"     This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of     PBT2 administered to healthy volunteers in the presence and absence of food.   "
90063|NCT02107300|"     To assess whether the daily use of NeutraSal will prevent or reduce dry mouth in patients     undergoing CPAP therapy for OSAS and improve CPAP compliance   "
90064|NCT02107287|"     Considering the promising results with hypofractionated in low and intermediate risk prostate     cancer, our proposal is to translate this experience to patients with high risk prostate     cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and     to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy.     The objective of the study is to show that long term grade>2 late toxicity is acceptable and     similar to published data using hypofractionated technique in the prostate only.   "
90065|NCT02107274|"     Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the     airways. Only a small number of clinical studies have been conducted investigating the use of     macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to     determine the efficacy of 12 weeks treatment with azithromycin in adult patients with     non-cystic fibrosis bronchiectasis.   "
90066|NCT02107261|"     The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®).     Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves,     inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In     musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be     critical for the musical professional to continue his or her career. With the use of     EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize     the individual muscles that are affected in this condition with great accuracy. Prior studies     have shown that BoNT injections produce beneficial effects in forearm muscles, and less     effect in shoulder or proximal arm muscles.      Possible risks in treating patients with BoNT include excessive weakness of the injected     muscles. The drug may also affect non-targeted muscles. However these risks will be minimized     during the screening period by carefully targeting the affected muscles and by administering     low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks     after the primary injection date) if the initial injection was insufficient to produce     sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of     the targeted muscle.   "
90067|NCT02107248|"     Aim of the current study is to test the non-inferiority hypothesis of differences in early     hip dislocation between a group of patients who will be restricted to sleep in supine     position and a group without restricted sleeping position during the first eight weeks after     a total hip replacement following a posterolateral surgical approach   "
90068|NCT02107235|"     The working hypothesis is that oral rigosertib treatment when added to platinum-based     Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with     intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck     Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib     that can be used with cisplatin and CRT. This study will also record any side effects that     may occur and measure tumor sizes and how long patients live.   "
90069|NCT02107131|"     Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on     day-to-day visual function in patients with Diabetic Macular Edema (DME).   "
90070|NCT02107118|"     Men who present with erectile dysfunction as defined as an IIEF (International Index of     Erectile Function) score less than 21 will be evaluated for risk factors for cardiovascular     disease (CVD). This is a single-blind study. Subjects will be randomized in a 2:1 fashion for     treatment (ARM 1) versus placebo (ARM 2). Adipose tissue (fat) will be harvested from all     patients and stem cells will be cultured. For those patients in the placebo arm the stem     cells will be frozen for later use after one year when the patients cross over into the     treatment arm.   "
90071|NCT02107105|"     The goal of this study is to learn about quality of life in patients who have or have had     rectal cancer.   "
90072|NCT02107092|"     Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29     visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l     inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and     have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on     Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the     option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004     due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will     not be entered into study ZS-004E. All subjects who continue into the extension study must     begin dosing within two (2) days after the last dose of investigational product in ZS-004.   "
90171|NCT02105792|"     This study will examine extreme responders to second- and third-line Type 2 diabetes therapy     using a prospective approach, and patients with slow or fast diabetes progression using a     retrospective approach.   "
90073|NCT02107079|"     The circadian rhythm, the sleep-wake cycle, is mainly regulated by melatonin. The synthesis     of melatonin is stimulated by the absence of light, leading to peak serum levels before     bedtime. In humans, this endogenous signaling neurohormone induces sleep. Exogenous     melatonin can be beneficial in different sleep disturbances including delayed sleep phase     insomnia, melatonin- deficiency-related insomnia (especially in elderly) and shift work sleep     disorder. Melatonin is known for its low and variable bioavailability in humans due to a high     first pass effect and variable pharmacokinetics and short half-life. In order to prevent     exposure of patients with unnecessary high dosages of melatonin and in order to achieve a     short Tmax and high bio-availability of melatonin, a proper formulation needs to be defined.     This study, a three-phased cross-over study, aims to define a proper formulation for oral and     oromucosal melatonin for the treatment of insomnia by investigating the Tmax and relative     bioavailability derived from melatonin levels in salivary samples of healthy volunteers after     administration of melatonin in different formulations: 2,5mg melatonin immediate release     capsule (produced by Apotheek UMCU), 1mg melatonin immediate release tablet (produced by     Tiofarma), low-dose 0.1mg melatonin original Sleepzz tablet (produced by Vemedia     Manufacturing BV).   "
90074|NCT02107066|"     Despite an increase in longevity, surviving ovarian cancer often brings an array of     unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to     test whether exercise compared with attention control has a beneficial impact on quality of     life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and     important role for exercise in ovarian cancer care given that physical and functional aspects     of QOL are often the most compromised in ovarian cancer patients.   "
90075|NCT02107053|"     Atherosclerosis and its related cardiovascular morbidity and mortality, underlie many chronic     diseases. Most atherosclerotic patients have multiple cardiovascular risk factors, which     potentiate each other, causing a huge burden on health systems. In order to improve the     understanding and treatment options of atherosclerosis, it is necessary to identify common     basic pathways in its pathogenesis. Oxidative Stress (OS) has a major role in the     pathogenesis of atherosclerosis; however, good biomarkers to determine OS are still missing.   "
90076|NCT02107027|"     The aim of this study is to compare two type of ablation catheters for pulmonary veins     isolation (PVI) in subjects with atrial fibrillation.      Currently, two technologies of irrigated ablation catheters are available for PVI.      One of the two, the conventional catheter is widely used for atrial fibrillation (AF)     treatment but has not been specifically created for pulmonary veins isolation, therefore,     point by point encircling lesions are cumbersome and time consuming.      The second is a new ablation catheter with a circular shape provided with 10 irrigated     electrodes designed to create encircling lesions, necessary to obtain pulmonary veins     isolation, could allow an easier and faster isolation compared to the conventional way.      These two types of catheters have never been compared for atrial fibrillation. If one of the     two catheters appears to be more efficient or causes fewer complications, the use of this     catheter could be favored to conduct AF ablation.   "
90077|NCT02107014|"     We have found that low dose naltrexone (LDN) can substantially reduce pain associated with     fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The     purpose of this study is to determine if LDN lowers inflammatory markers in individuals with     fibromyalgia.   "
90078|NCT02107001|"     Chest pain is an alarming symptom and one of the most frequent causes of access to the     Emergency Departement. Although chest X-ray remains an essential step in the diagnostic     process, several studies showed numerous limitations of radiography which frequently is     inconclusive. Ultrasonography is a non-radiating imaging technique. Albeit a wide use of     ultrasound, the utilization of ultrasound in the study of the lung has only recently been     introduced in the clinical practice. Several studies proved that lung ultrasound is useful in     the diagnosis of lung consolidation in community acquired pneumonia. Nowadays, ultrasound is     not routinely used in the presence of chest pain. Our hypothesis based on clinical experience     is that, in patients with pleuritic chest pain, lung ultrasound is very sensitive in     detecting pneumonia and other lung diseases (such as pneumothorax) thus performing better     than radiography. The primary aim of this study is to verify, in patients affected by     pleuritic chest pain, the accuracy of lung ultrasound compared to chest-X-ray. The secondary     aim is to evaluate the accuracy of lung ultrasound consolidations in distinguishing lung     consolidation in pneumonia, atelectasis, pulmonary infarction, or tumors.   "
90079|NCT02106988|"     The goal of this clinical research study is to learn if radiation therapy and chemotherapy     can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and     chemotherapy combination will also be studied.   "
90080|NCT02106975|"     Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ     failure as measured by Sequential Organ Failure Assessment (SOFA) score,      Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by     the oxygenation index and the VE40      Hypothesis 1C: Vitamin C infusion will attenuate biomarkers of inflammation (C-Reactive     Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar     epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a     fibrinolytic state (Tissue Factor Pathway Inhibitor).   "
90081|NCT02106962|"     This study will investigate how the use of Tranexamic acid and Bacitracin applied to the     bleeding site after the hemodialysis fistula needle is removed will affect skin wound     healing.   "
90082|NCT02106949|"     The study wants to prove that SMS monitoring reduced the number of suicide attempts in six     months according to the beginning of its implementation in the group of the patients     benefiting SMS compared with the group of patients benefiting from the usual care.   "
90172|NCT02105779|"     The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive     remediation in schizophrenia in order to maximize treatment response. The investigators will     investigate factors that have generally been ignored in prior computer-based cognitive     remediation programs—those related to social cognition-- and will delineate their     relationship to motivation, functional outcome, and the neural substrates of reward     anticipation and emotion processing. Current research indicates that, unless the     investigators fully understand and harness these factors, the investigators will not achieve     meaningful treatment gains for individuals with schizophrenia.   "
90083|NCT02106936|"     Background:      - Focal hand dystonia (FHD) causes muscles to contract, leading to abnormal movements or     postures. Musicians, writers, and athletes often get it. Researchers want to study how     patients with this condition learn, a process of the brain that depends on a property called     plasticity.      Objective:      - To study brain plasticity in people with FHD.      Eligibility:        -  Right-handed adults 18 years and older with FHD.        -  Healthy, right-handed adult volunteers.      Design:        -  Participants will be screened with medical history, physical exam, pregnancy test, and          questionnaire about their right-handedness.        -  Participants will have 2 study visits on 2 different days.        -  Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation          (TMS) pulses on the left side of the head. A brief electrical current passes through a          wire coil on the scalp. They will hear a click and may feel a pulling on the skin or          muscle twitches. They may have to keep their eyes open and remain alert, tense certain          muscles, or perform simple finger movements.        -  Forty more pulses, with 10 seconds between, will be given on the left side of the head.          Some will be small, some big.        -  Researchers will measure muscle response through small electrodes taped to the right          hand.        -  A cloth cap will be put on the participant s head. Researchers will write on tape on the          cap.        -  Participants will have the r-PAS. An electrical stimulator will be placed on the nerve          at the right wrist. Repeated magnetic pulses will be delivered in trains or short bursts          together with electrical stimulation of nerve. Participants will receive up to 840          pulses.        -  Participants will be contacted after a few days for a follow-up check.   "
90084|NCT02106923|"     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed     fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and the single     tablets of empagliflozin and metformin XR when administered singularly   "
90085|NCT02106910|"     Subjects presenting to UNC Hospitals for routine endoscopic surveillance examinations for     current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of     dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. After informed     consent, and the same day as the endoscopic procedure, the subject will undergo     administration of the Cytosponge assay. The patient will then undergo routine endoscopic     surveillance, using a standard Seattle biopsy surveillance protocol. The Cytosponge will be     placed in fixative and shipped to the Fitzgerald laboratory at the University of Cambridge     for processing according to their established protocols. Tissue biopsies will undergo     standard processing and H&E staining, with assessment by expert gastrointestinal pathologists     at UNC. The primary outcome variables will be sensitivity and specificity of the novel assay,     compared against the gold standard of the presence of recurrent BE as detected by upper     endoscopy with biopsies. Secondary outcomes include acceptability of the nonendoscopic assay     to the patient (assessed by a standardized tool, the Impact of Events Scale, as well as a     visual analogue scale), and likelihood of assay positivity as a function of amount of     residual disease (as measured by Prague criteria).   "
90086|NCT02106897|"     The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either     single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 in     healthy volunteers (HV), and a single IV dose in participants with Systemic Lupus     Erythematosus (SLE). The primary objective of Part 3 is to evaluate the safety and     tolerability of multiple SC doses of BIIB059 in healthy volunteers and in participants with     SLE.      Secondary objectives of Parts 1 and 2 are as follows: To estimate the PK parameters of     single-ascending IV doses of BIIB059 in healthy volunteers and a single IV dose of BIIB059 in     participants with SLE; To estimate the PK parameters and bioavailability (F) of a single SC     dose of BIIB059 in healthy volunteers; To evaluate the immunogenicity of BIIB059 administered     to healthy volunteers and participants with SLE. Secondary objectives of Part 3 are as     follows: To estimate the PK parameters of multiple SC doses of BIIB059 in healthy volunteers     and in participants with SLE; To evaluate the immunogenicity of BIIB059 administered SC to     healthy volunteers and participants with SLE.   "
90087|NCT02106884|"     This is a quality of life study done in the context of a randomized trial in pancreatic     cancer. Patients with locally advanced or metastatic pancreatic adenocarcinoma receive either     the combination of nab-paclitaxel gemcitabine or the existing standard gemcitabine alone     treatment.The combination regimen of nab-paclitaxel and gemcitabine administered in patients     with locally advanced or metastatic pancreatic cancer in a first line setting showed improved     efficacy with acceptable toxicity. The current study design allows patients in standard     treatment to receive the combination treatment at tumour progression.      The proposed study will explore the impact of treatment on the quality of life and compare     the times to definitive deterioration of the quality of life scores using the validated EORTC     QLQ-C30. Efficacy and safety secondary endpoints are to be reported in a descriptive manner.      Molecular studies will be performed on blood and tissue samples.   "
90088|NCT02106871|"     Investigation of the effects of daily sildenafil on patients with pancreatic or     cholangiocarcinoma cancer undergoing treatment.   "
90089|NCT02106858|"     To investigate and collect post-marketing data on the safety of Stivarga in real world     practice in its registered indication(s) as required by Health Authority.   "
90090|NCT02106845|"     Evaluate the effect of regorafenib on the pharmacokinetics of digoxin (P-gp substrate :     P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by     comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on     Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients   "
90091|NCT02106832|"     The purpose of this study is to evaluate if the time to first pulmonary exacerbation of     bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days     every other 28 days or for 14 days every other 14 days over 48 weeks.   "
90182|NCT02105649|"     It will be hypothesized that strengthening the calf muscles will improve standing efficiency     in children with spastic diplegia.   "
90183|NCT02105636|"     The purpose of this study is to find out whether Nivolumab will significantly improve overall     survival as compared to therapy of investigator's choice in patients with recurrent or     metastatic head and neck carcinoma.   "
93463|NCT02062710|"     The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two     liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa     flavoring, and, dextromethorphan syrup, compared with placebo.   "
90092|NCT02106819|"     The cerebellum has been linked to cognitive and emotional functions and there is increasing     evidence that damage to posterior portions of the cerebellum can result in frontal-executive,     visuospatial, and verbal deficits, including dysprosodia, and affective changes including     blunting of affect or disinhibited and inappropriate behavior. Based on preliminary clinical     observations and tests performed in the investigator's clinic, disorders of emotional     communication may also be associated with cerebellar dysfunction. Emotional communication     includes the production and comprehension of facial and prosodic expressions and is critical     to maintaining positive and supportive relationships. Deficits in emotional communication can     have devastating effects on relationships and on quality of life for those affected. Although     deficits in affect and prosody have been reported in association with posterior cerebellar     disorders, there are currently no studies systematically investigating emotional     communication in individuals with cerebellar dysfunction. It is known that the cerebellum has     strong connections with the cerebral cortex, especially the frontal lobes, and that cortical     damage from stroke or neurodegenerative disease can result in disorders of emotional     communication. Impairments in the integrity of cerebellar-cerebral networks from cerebellar     disease may produce similar deficits in emotional communication. The purpose of this study is     to systematically investigate and describe deficits in emotional communication in a series of     patients with cerebellar disease. Participants will be individuals diagnosed with posterior     cerebellar degeneration or damage from a non-hemorrhagic infarction, and age-matched     neurologically healthy controls. Assessment will include a battery of tests of     neuropsychological function as well as tests of emotional communication. Comprehension of     emotional facial and prosodic expressions will be assessed as well as production of emotional     communication. The expected outcomes will be to identify and describe deficits in production     and comprehension of emotional prosodic and facial expressions and to describe the     relationship between deficits in emotional communication and cerebellar atrophy with magnetic     resonance imaging imaging (MRI) using voxel based morphometry (VBM).   "
90093|NCT02106806|"     Objective: To determine the oxidative stress during cycles of chemotherapy in patients after     surgery for colorectal cancer, with or without oral zinc supplementation. Subjects: Twenty     four adults from both genders participated in this study. All patients underwent stage II,     III or IV colorectal cancer surgical resection and were starting chemotherapy in HCFMRP- USP.     Patients were randomized into two groups. The first one (QTx-Zn Group, n=10) received 70 mg/d     of zinc orally and the second one received placebo (QTx-Placebo Group, n=14) for 16 weeks.     The study also included 30 healthy volunteers matched for age, gender and socioeconomic     status, who received 70 mg/d of zinc supplement (Control-Zn Group, n=21) or placebo     (Control-Placebo Group, n=9) for 16 weeks. Methods: The questionnaires about dietary intake     (semiquantitative food frequency and food record), fatigue and quality of life (FACIT-F) and     questionnaires that assess the side effects of chemotherapy (CTCAE) were evaluated.     Anthropometry and bioelectrical impedance measurements were made. Blood collection was     performed before the 1st, 2nd, 3rd and 4th cycles of chemotherapy (median duration of 21 days     among cicles). Routine laboratory tests, vitamin E and markers anti and pro-oxidants (MDA,     SOD, GPx and isoprostane) ere determined. The control group underwent the same procedures,     except for chemotherapy. A longitudinal linear mixed effects model was adjusted for each of     the variables of interest. The models were fitted using PROC MIXED of SAS version 9 (SAS,     CARY, NC, USA). To analyze the association of categorical variables in the different items of     the CTCAE, the investigators used the Fisher exact test. Results: The oral zinc     supplementation was sufficient to increase plasma levels of zinc and did not alter food     intake, body composition and routine laboratory evaluation of patients undergoing     chemotherapy for colorectal cancer. Compared with QTx-Placebo Group, QTx-Zn Group showed     lower prevalence of complaint on the salivary gland (17 vs. 75%). Fatigue (43 ± 6 vs. 36 ±     13) and quality of life (126 ± 160 vs. 116 ± 27) has become worst in the period between the     1st and 4th cycles of QTx in QTx-Placebo Group. When compared with QTx-Placebo Group, QTx-Zn     Group had higher values of SOD before the 1st (2297 ± 503 vs. 1604 ± 352 USOD/g Hb), 2nd     (2037 ± 515 vs. 1712 ± 417 USOD/g Hb) and 4th (2202 ± 323 vs. 1821 ± 360 USOD/g Hb) cycles of     QTx. GPx values decreased in QTx-Zn Group before the 3rd cycle of QTx (48.5 ± 7.0 vs. 54.3 ±     2.3 mol NADPH/min/gHb). Conclusions: These data suggest that zinc supplementation reduces     complaints related to the change in salivary gland, preserving the quality of life and     preventing the worsening of fatigue. The increase in SOD can be attributed to zinc     supplementation per se, whereas this mineral is a cofactor that endogenous antioxidant     enzyme. The highest activity of SOD increases the production of H2O2, whose detoxification     involves the participation of GPx, justifying its reduction. There were no changes in plasma     levels of vitamin E, MDA and isoprostane during the study period. Considering the values of     MDA and isoprostane, the data indicate that regardless of zinc supplementation, the lipid     peroxidation of the cell membrane was unchanged during chemotherapy.   "
90094|NCT02106793|"     Primary objective        -  To compare the incidence of postoperative nasal synerchia between Mitomicin C and          placebo in patients at 6 months after endoscopic sinus surgery        -  To validate the Thai version of disease-specific quality of life tool SNOT-22      Secondary objectives        -  To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C          with those who receive placebo        -  To compare the disease-specific quality of life in patients who receive Mitomicin C with          those who receive placebo        -  To compare the side effects of Mitomicin C versus placebo   "
90095|NCT02106780|"     Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and     feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are     collected until at least 144 hours after dosing.   "
90096|NCT02106767|"     The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will     be studied in clinical trial in White and Asian healthy volunteers.   "
90097|NCT02106754|"     This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide     for Children and Adolescents. Of particular interest to the agency are evaluation of the     Screener in clinical and/or other settings to predict alcohol-related consequences including     use disorder; its use as an initial screen for drug use, cigarette smoking, conduct disorder,     and unprotected sex; and its performance in making predictions concurrently and     prospectively. This proposal targets these areas of interest. In addition, the investigators     will study implementation of the Brief Intervention (BI) associated with the Screener. There     is a great need for both screening and BI in juvenile probation settings as many of these     youths have great need but are underserved.Many probation departments are turning to BI to     work with probationers and parolees. Screening and BI has demonstrated efficacy in these     settings, and yet no randomized control trials have been conducted to evaluate effectiveness     in juvenile probation settings. Probation Officers (POs; n=40) are randomized to Screener     (S), Screener+BI (SBI), or coaching (CSBI). Youths (N=1000) are randomized to 1 of these 3     conditions, and all receive usual services (US). US consist of regular check-in with PO and     access to referral services as needed (counseling, academic tutoring, etc.). Research     staffers conduct in-depth assessment at baseline, 6- and 12- months. Sensitivity,     specificity, and positive and negative predictive powers (SN, SP, PP, NP) are calculated to     predict alcohol risk and consequences, as well as other risky behaviors concurrently and     prospectively across age-groups. A 1-way design (S vs SBI vs CSBI) will be used to determine     whether SBI and CSBI enhance youth services-use and reduce risks (e.g., alcohol use, risky     sex). We examine moderators of outcomes (youth age, PO characteristics) and whether coaching     (an important consideration in implementation science) in use of BI improves outcomes. This     study will be the first randomized controlled trial evaluating the effectiveness of SBI in a     juvenile probation setting.   "
90098|NCT02106741|"     The purpose of this study is to compare two kinds of self-administered acupressure     (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue     and pain in low back pain patients.      Hypothesis: Self-administered relaxation acupressure will result in improvements in fatigue     and sleep quality, pain, and physical function compared to stimulating acupressure and usual     care.   "
90099|NCT02106728|"     Eating Disorders are a debilitating and serious mental illness. This illness is associated     with medical complications, psychological and social impairment. Families of people with an     eating disorder also report that they lack resources and have many unmet needs. Families     often have insufficient information regarding the eating disorder, available treatment     options and strategies for supporting the person with the illness. The purpose of this study     is to evaluate the effectiveness of two different family interventions for people with eating     disorders and their family members (parents or partners) receiving treatment either in the     inpatient or day treatment Eating Disorder Program at the Toronto General Hospital,     University Health Network. Family supportive counseling consists of people with eating     disorders and their family members meeting with a family therapist. Multi-family group     therapy involves eight to ten families who meet as a group with two therapists. The     investigators are conducting a study to assess the differences between these two different     family interventions. This study will help us identify who benefits the most from     participating in family supportive counseling or multi-family therapy. The investigators are     also evaluating which intervention is more effective at helping the person with the eating     disorder overcome their illness while helping their family members learn how to support the     recovery process. Both family therapy interventions are delivered by experienced family     therapy clinicians who work in either the Inpatient or Day Treatment Eating Disorder Program     at Toronto General Hospital.   "
90100|NCT02106715|"     The purpose of this study is to investigate the prevalence of overload injuries to road     cyclists in Sweden, and if it 's possible to prevent low back pain by a simple exercise     program for two months of training .   "
90101|NCT02106702|"     Each year, there are over 600 unduplicated HIV-infected persons incarcerated in the San     Francisco jail. Two thirds of those released with HIV-focused discharge planning are     reincarcerated within one year. More than half of HIV-infected jail inmates are diagnosed     with mental health conditions severe enough to require medication and a similar proportion     report substance use disorders at the time of detention. While some community-based services     exist, there remains a critical need to improve linkages to care and adherence to care plans     for HIV-infected adults as they move between community and jail. The Navigator Project is a     five-year randomized study that will test the effectiveness of an intensive enhanced case     management intervention to reduce sex and drug-related HIV transmission risk; increase HIV     medication adherence; reduce drug dependence; and reduce reincarceration.   "
90102|NCT02106689|"     The daily injections required for superovulation, a fertility treatment using injections to     stimulate a women's ovaries to produce multiple eggs, can be an anxiety provoking process for     many women and a deterrent to treatment. Alternative needle-free injection systems have been     developed with the intention of reducing needle phobia and pain, while providing similar     results. However, these needle-free systems are not yet being widely used for women with     infertility.      The purpose of this study is to assess whether the pain and apprehension patients often     associate with needles and injections, can be alleviated by using a new, Health Canada     approved, needle-free system. The purpose of the current study is to assess whether patient     satisfaction is improved in patients using a needle free injection system for the daily self     injections required for superovulation induction as compared to patients using the standard     needle and syringe.   "
90103|NCT02106676|"     The aim of this study is to determine maternal androgen metabolism during pregnancy and the     impact of androgen disorders on mothers and infants.   "
90104|NCT02106663|"     This is a PI-initiated study that aims to evaluate the efficacy of two different methods of     paroxysmal atrial fibrillation (PAF) ablation. There are currently two strategies for PAF     ablation that are routinely performed by electrophysiology clinicians: (1) circumferential     pulmonary vein ablation (CPVA) and (2) segmental pulmonary vein isolation (SPVI). However, it     is not known if one approach is better than the other. This randomized study will evaluate     and compare the efficacy of CPVA versus SPVI in subjects undergoing ablation for paroxysmal     atrial fibrillation only. Subjects will have a 50/50 chance of receiving either the CPVA or     SPVI ablation method.   "
90105|NCT02106650|"     This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related     Grade 3 or higher oral mucositis.   "
90106|NCT02106637|"     The hypothesis of this study is that combination of Varenicline treatment with nurse-led     hospital support during hospitalization and after discharge will result in clinically     significant higher long term abstinence rates in smokers with ACS, as compared with nurse led     support and placebo, without a significant increase in the risk of adverse events.   "
90107|NCT02106624|"     The patients with sepsis are in high risk of malnutrition, which could contribute to     infection, difficulty in weaning from ventilators. The investigators speculate whether     nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the     outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the     investigators aim to compare high nitrogen intake with conventional nitrogen supply which     were recommended in guidelines.   "
90108|NCT02106611|"     This study will test whether cardiac MRI can improve early detection of Hodgkin lymphoma     associated heart disease compared to a stress echocardiogram. By doing both stress     echocardiography and cardiac MRI, we will compare the ability of the two tests to detect     heart disease.   "
90109|NCT02106598|"     Current imaging devices usually detect cancer prior to surgery. However, these devices cannot     be used during the surgical procedure to visualize lymph nodes with cancer (called sentinel     lymph nodes). The groups are for head and neck melanoma, gynecologic, and breast cancers. As     a part of the standard of care, the they will initially undergo imaging of their lymph nodes     prior to their surgery. Melanoma and breast cancer patients will be injected with a     radioactive dye around the tumor site, and images will be acquired about 2 hours the location     of the later using a device to image the dye. For gynecologic cancer patients, they will be     injected with a indocyanine green in the operating room and then images will be acquired soon     after. In addition, the investigators will test, for the first time in humans, a new,     experimental dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node mapping. This     particle, the size of a small protein, will be injected around sites of melanoma before or     during your surgery to identify diseased nodes using a hand-held camera system. The     dye-labeled particle can be viewed in tissues that may contain tumor. Based upon the clinical     diagnosis, the patient may have a procedure called Reverse Lymphatic Mapping, which is a new     form of sentinel lymph node mapping. The doctor will discuss this with the patient. If the     patient is undergoing reverse lymphatic mapping, they will have the experimental particle     injected into their hand or foot (based on their tumor type) and the standard of care     injection will be injected around the tumor. This will allow the surgeon to remove only the     lymph nodes that directly link to the tumor. The particles will not treat the cancer and any     images or information found during this study will not be used for your treatment. The     information collected may be used to guide the design of future studies to detect and/or     treat tumors.   "
90110|NCT02106585|"     The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics)     of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to     evaluate the effect of food on the PK of JTT-251 in healthy subjects.   "
90111|NCT02106572|"     The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with     Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of     the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM®     900, in particular, to compare the toxicity of the two treatments. Another secondary     objective is the treatment efficacy as measured by calculated prognosis for recurrence and     progression after 1 year, the tumor grading in case of a recurrence and by measurement of     Quality of Life.   "
90112|NCT02106559|"     This pilot clinical trial studies photodynamic therapy during surgery in treating patients     with pleural (the protective lining or membrane that covers the lungs and chest cavity)     malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer     (a substance that makes cells more sensitive to light), such as porfimer sodium, together     with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply.     Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain     after surgery.   "
90113|NCT02106546|"     This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of     veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and     paclitaxel in subjects with advanced or metastatic squamous NSCLC.   "
90114|NCT02106533|"     The purpose of the present study was to test the hypothesis that patients with coronary     artery disease with lower aerobic fitness exhibit greater responsiveness on improving     ventilatory efficiency after aerobic exercise training.   "
90184|NCT02105623|"     The purpose of this study is to compare standard therapy (risk factor control, life style     modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on     progression of coronary atherosclerosis in statin naive individuals who have mild CAD     (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein)     cholesterol levels(〈130mg/dl).   "
90295|NCT02104167|"     The purpose of this combined retrospective and prospective clinical study is to examine     safety and efficacy of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE®     plating to treat single level degenerative disc disease between C2 and T1 in the short term,     with a focus on fusion rates.   "
90115|NCT02106520|"     Hereditary Hemorrhagic Telangiectasia (HHT) is a rare (~ 1/6000) but ubiquitous genetic     disease. It is associated with abnormal angiogenesis and autosomal dominant inheritance,     leading to telangiectasias and arteriovenous fistulae. More than 95% of patients are     concerned by epistaxis (nosebleeds). These events are spontaneous, repeated, irregular, both     diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing.      Anti-angiogenic treatments, including bevacizumab, are a new therapeutic option in HHT.      The aim of this study is to evaluate 3 months after the end of the treatment the efficacy on     the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab     administered as a nasal spray in a repeated manner (3 administrations) in patients with     Hereditary Hemorrhagic Telangiectasia complicated by nosebleeds.      This randomized, double-blind, placebo-controlled, seamless phase II/III study is to be     carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for     second step   "
90116|NCT02106507|"     The purpose of this study is to test the safety of the combination of apalutamide plus     everolimus at different dose levels.   "
90117|NCT02106494|"     The primary study objective is to demonstrate the superiority of APF530 500 mg given     subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a     maximum of 16 mg) in the delayed-phase (> 24-120 hours) complete response (CR) rate (defined     as no emesis and no use of rescue medications) in subjects receiving highly emetogenic     chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines   "
90118|NCT02106481|"     The purpose of this study is to compare two methods of pain control used during total knee     joint replacement surgery. The pain medication that will be used for this study is not     experimental.      The investigators will compare the single shot femoral nerve block (SSFNB) and Femoral Nerve     Block (FNB) plus continuous femoral nerve catheter (CFNC) to determine which method gives     patients better pain control, increasing the capability to participate in physical therapy     and decreasing the consumption of other pain medication. With either the single shot or the     catheter the local numbing medication called ropivacaine will be used.   "
90119|NCT02106468|"     This study was initiated to evaluate the potential of dietary supplementation of omega-3 for     providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive     lichen planus.   "
90120|NCT02106455|"     The purpose of this study is to evaluate the safety and efficacy of sodium risedronate     tablets (Benet 17.5 mg Tablets) administered once daily (one tablet per dose) in patients     with osseous Paget's disease for 48 weeks from baseline in daily medical practice.   "
90121|NCT02106442|"     The purpose of this study is to evaluate the efficacy (endpoints: frequency of bone     fractures, percent change in bone density, etc.) and safety of administration of sodium     risedronate tablets (Benet 75 mg Tablets) for 36 months in osteoporosis patients in daily     medical practice.   "
90122|NCT02106429|"     Pathological and clinical studies have consistently demonstrated that abnormalities in     thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and     atherothrombosis. Screening for abnormalities in thrombosis and hemostasis by measuring     platelet activity, thrombin generation, and markers of coagulation have been proposed to     identify individuals at high-risk for cardiovascular events, however, it remains a research     tool not ready for implementation in standard care.      The proposed study will add to the growing understanding of platelet activity and markers of     coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity     markers, thrombin generation, markers of coagulation, and inflammatory biomarkers in subjects     undergoing vascular surgery; and will provide important data on the mechanism of increased     platelet activity using micro RNA, RNA and DNA expression profiling. The study design is     prospective and the main outcome measures are platelet activity, coagulation markers and     incident cardiovascular and bleeding events.   "
90123|NCT02106416|"     The purpose of this study is to develop a novel technique for integrated PET/MRI tracer     kinetic analysis for urologic malignancy.   "
90124|NCT02106403|"     The objective of this randomised, examiner and subject blinded study is to evaluate and     compare cooling performance and overall consumer liking of the prototype formulation with the     currently marketed wound spray and negative control in subjects with experimental wounds. For     each subject, three superficial wounds will be induced on two volar forearms, by sequential     tape strippings until a glistening layer is visualized. After wounding, a randomised test     product will be sprayed twice on test site, and the subject will be asked to complete a     questionnaire evaluating product cooling performance and overall liking.   "
90125|NCT02106390|"     The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability     of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at     3, 5, 7 and 13 months of age, compared to either alone.   "
90126|NCT02106377|"     Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse     therapy, administered twice daily (to avoid adverse effects associated with long-term steroid     use). This timeframe is often too short to meaningfully resolve the inflammation associated     with DED. Thus, corneal specialists, including here at MEEI, have begun using steroid     treatment of at least 6 weeks with tapered dosing.      In vivo confocal microscopy (IVCM) is a novel imaging technology that allows the     visualization and quantification of certain corneal features associated with DED, such as     hyperfluorescent superficial epithelial cells, immune dendritic cells, and sub-basal nerves.     Recent cross-sectional studies have begun to shed light on the correlation of these features     with traditional outcome measures typically assessed in DED, such as corneal and conjunctival     staining, Schirmer's testing, tear break-up time (TBUT), and symptom questionnaires. However,     longitudinal studies using IVCM to demonstrate how steroid treatment affects the corneal     epithelial cells, dendritic cells and nerves are largely lacking. Furthermore, studies on the     safety and efficacy of a 6 week tapered dosing steroid regimen are also lacking.   "
90127|NCT02106364|"     The main purpose of this study is to compare the efficacy and safety of a new basal insulin,     insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM).     Both drugs will be given by an injection under the skin. Participants may continue to take     oral antihyperglycemic medication (OAM) during the study, as prescribed by their personal     physician. The study is expected to last about 12 months for each participant.   "
90130|NCT02106325|"     Investigators will conduct a trial to evaluate the use of Ketamine as an alternate treatment     for people with Major Depressive Disorder. This study plans to explore the potential that     Ketamine's rapid antidepressant action holds for improving outcomes in patients presenting to     the Emergency Department with severe depression. since this is a controlled trial we will use     an IV of Ketamine or and equivalent volume of Diphenhydramine. Sixty subjects will be     randomly assigned to receive Ketamine (30 participants) or Benadryl(30 participants).     Investigators will then compare measures of mood pre- and post-infusion in the Emergency     Department. to supplement self-reported measures of depressive symptoms(e.g. mood),     investigators will obtain objective measures of the biological aspects of Major Depressive     Disorder. With the current evidence pertaining to our hypothesis, investigators hope to add     to the growing scientific studies surrounding such a vulnerable population.   "
90131|NCT02106312|"     To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid     Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.   "
90132|NCT02106299|"     To evaluate the treatment safety and efficacy of Regen Sling developed by medprin     Regenerative Medical Technologies Co., Ltd. for female patients with stress urinary     incontinence   "
90133|NCT02106286|"     A major determinant of perioperative mortality is the inability of the heart to increase its     output in response to surgical stress. This is termed perioperative cardiac failure (PCF),     and may only be apparent postoperatively when oxygen demand is increased. The risk of     perioperative cardiac complications is the summation of the individual patient's risk and     cardiac stress related to the surgical procedure1. The functional capacity of the patient     determines their ability to support the postoperative demand of increased oxygen consumption,     and therefore of cardiac output. Exercise capacity is one of the most powerful predictors of     cardiovascular and all cause mortality2. Cardiopulmonary exercise test (CPET) is an     established investigation used, among other applications, in the preoperative assessment of     patient fitness for surgery3. CPET involves monitoring the electrocardiographic trace and the     exhaled gas mixture (particularly CO2, whose production depends on aerobic metabolism),     during incremental exercise (usually on an exercise bike), on room air. Several parameters     can be measured during CPET, including maximal systemic oxygen delivery, the anaerobic     threshold (the oxygen delivery value at which anaerobic metabolism begins), maximum workload,     and ST segment depression/elevation (as in a standard exercise tolerance test). The     cardiopulmonary performance during CPET has been correlated with postoperative outcome3.     Pulmonary function tests will be performed in order to assess lung function.      It is well known that therapy with beta-blockers in patients with ischaemic heart disease and     cardiac failure reduces perioperative morbidity and mortality4-7. However, beta blockers     reduce myocardial contractility and the heart rate response to adrenergic stimulation, thus     blunting the physiological response to stress/surgery/exercise. Whilst this mechanism may     protect the heart perioperatively, it may decrease the ability of some patients to withstand     other complications. This potential decrease in performance has never been quantified.      There is no agreement on whether preoperative CPET should be performed on or off     beta-blockers and, at Aintree in particular, it is standard procedure to take patients off     beta-blockers prior to their CPET. Some argue that, as beta-blockade should be maintained in     the perioperative period, CPET should be performed on medications, even if these could mask     the presence significant ischaemic heart disease (a significant, modifiable, risk factor for     surgery by beta blockade), and even if it is not always possible to maintain beta-blockade     throughout the whole postoperative period. For these reasons, other clinicians prefer to     perform CPET off beta-blockers, thus, potentially, overestimating the perioperative     cardiorespiratory performance, which may be diminished once the medications are resumed.     Patients on long-term beta blockade may develop some tolerance to the medications, so the     effect of acute and chronic beta blockade on cardiorespiratory performance may also be     different.      Aim To compare cardiopulmonary performances on and off beta blockers as objectively assessed     by cardiopulmonary exercise testing.   "
90134|NCT02106273|"     An observational pilot study to determine the success rate of using LMA Proseal in conjuction     with endobronchial blocker to provide one-lung anesthesia for thoracic surgery.   "
90135|NCT02106260|"     This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to     assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of     topically applied CLS003 in healthy subjects with cutaneous warts.   "
90136|NCT02106247|"     To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate     pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.   "
90137|NCT02106234|"     Contrast-induced nephropathy (CIN) is a side-effect of intravascular administration of     iodinated contrast material. It is defined as an absolute (>44μmol/l) or relative (>25%)     increase in serum creatinine from baseline values within 48-72 hours of iodinated contrast     material administration, and usually resolves within two weeks. In some cases CIN has been     associated with persistent renal failure, increased risk of dialysis, and mortality. It is     not clear however, whether CIN is causally related to this increased risk or whether risk of     morbidity and mortality is inherent in those at risk of CIN.      CIN itself is asymptomatic and no treatment for CIN exists. Therefore, the focus lies on its     prevention. Prevention guidelines have been drawn up in most countries and been implemented     in most radiological departments. In the Netherlands, currently two guidelines for the     prevention of CIN coexist, issued by CBO (Centraal BegeleidingsOrgaan) and VMS (Veiligheids     Management Systeem).      The prevention guidelines aim to increase patient safety by identifying patients that may be     at risk of CIN (mostly patients with chronic renal insufficiency), and subsequently     administering prophylactic intravenous hydration to the so identified patients, in order to     prevent CIN (intravenous normal saline 4-12 hours before and 4-12 hours after exposure to     iodinated contrast material).      Needless to say, the introduction of these guidelines has had a great impact on patient- and     health care burden. In the Netherlands alone it is estimated that yearly 100.000 to 150.000     patients receive the prophylactic treatment, incurring a total cost of over 50 million Euro.     Considering the steady yearly increase of contrast procedures and the ageing population, it     is evident that, in future, these numbers shall only increase further.      The prophylactic treatment prescribed by the guidelines is based on a consensus of the     opinion of experts in general agreement that the treatment is beneficial. However, the     effectiveness of prophylactic hydration has never been adequately evaluated. Sufficiently     large randomised trials comparing prophylactic intravenous hydration with a proper control     group receiving no prophylactic treatment are not available, and baseline CIN incidences in     untreated populations are unknown. Thus, it is not clear whether prophylactic hydration     achieves its aim to prevent CIN.      In order to be able to take effective measures to the benefit of patient safety, it is     important to distinguish between the mechanisms underlying CIN and the ensuing increased risk     of morbidity and mortality: whether it be biological variation of serum creatinine, renal     damage, or cholesterol embolism; whether any causality exists between these and iodinated     contrast material; and whether prophylactic intravenous hydration can prevent these from     occurring without incurring more risks than it removes. These, in short, are the aims of the     AMACING study.   "
90138|NCT02106221|"     The purpose of this study is to support enhancement, implementation, and evaluation of an     improved model for delivering improved primary care to high-risk older adults through the use     of health IT tools, focusing on issues related to the patient-centered primary care home     (PCPCH) and other similar high-value elements that are proposed to improve patient outcomes.     During this study, participating clinics will utilize the already-implemented Integrated Care     Coordination Information System (ICCIS). Clinic staff will meet with a practice facilitator     (monthly and as needed), and will track study activities and submit invoices via ICCIS     reporting. These invoices will be used to simulate a shared savings model where clinics will     be reimbursed based on their progress and effort towards their goals.      Clinics will set and work towards goals that they have chosen. Goals for the control arm are     self-selected by the clinics themselves; goals for the invention arm are related to     high-value elements (HVE) that have been identified as areas that can improve patient     outcomes. These HVE are:        1. Evidence-based Care Management Based on Need        2. Identification of At-Risk Populations        3. Patient Engagement and Alerts Based on Goals        4. Integrated Information for Care Management, especially around Utilization        5. Population Management Tools   "
90140|NCT02106195|"     The primary objective is to assess the safety and tolerability of 200 mg of KD025     administered orally once daily for 28 days   "
90143|NCT02106156|"     This observational study will examine the efficacy and safety of pegylated interferon     (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis     C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated     CHC patient population in Germany is expected to be studied over a period of 5 years.   "
90144|NCT02106143|"     Cryotherapy has a long history of safe use in various medical procedures. RejuvenAir System     radial spray cryotherapy is a novel procedure being developed as a treatment for conditions     associated with abnormal bronchial function, such as chronic bronchitis. The development of     appropriate reliable equipment, definition of therapeutic parameters, and an understanding of     the tissue effects of treatment have been established through animal studies. This clinical     study is being undertaken to assess the feasibility and safety of the application of a radial     metered dose spray cryotherapy in the human airway and to evaluate the treatment depth in     human airways. The study design is prospective, open label, single arm multi-center study     that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and The     Netherlands RejuvenAir System treatment will be performed during preoperative bronchoscopy 0     to 60 days prior to prescheduled lung resection in Subjects requiring lobectomy or     pneumonectomy for removal of peripheral tumors. Treatment will be limited to areas of the     bronchi within the lobe that will be removed, distal to the anticipated margin of resection.     Treatment should be at least 1 cm from the bronchial resection margins and away from the     tumor bed. Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and     examined histologically following surgical resection. Subject participation will be from 1 to     60 days and enrollment is anticipated to take 4-5 months.Total study duration is expected to     last approximately 10 months.   "
90145|NCT02106130|"     The investigators investigate the potential pharmacokinetic drug-drug interaction between     Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive Mosapride     citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.   "
90146|NCT02106117|"     Although the clinical outcome in patients with Invasive Aspergillosis (IA) is largely     dependent on early initiation of effective treatment with antifungal drugs, diagnosing IA is     still a critical problem. Symptoms are non-specific and available diagnostic tools are either     invasive or have low sensitivity and specificity. This often results in a diagnostic delay,     with patients developing more extensive disease. Furthermore, as long as IA is present,     oncological follow-up treatment is not feasible. Inaccuracy in diagnosing IA can cause     serious treatment delay and increased mortality. However, an empirical strategy with     prophylactic anti-mould therapy is not feasible considering both possible side effects and     costs. In order to safely continue the use of a pre-empirical strategy, improved     (non-invasive) diagnostic tools are desirable.      In a pilot study de Heer et al. showed that it is possible to discriminate between patients     with IA and their neutropenic controls by exhaled breath analysis using an electronic nose     (eNose). In this study the investigators aim to test whether an eNose could be useful as a     diagnostic tool in a prospective setting.      The gold standard in exhaled breath analysis is Gas Chromatography - Mass Spectrometry     (GC-MS). This technique enables identification of volatile organic compounds (VOCs) in breath     of patients. It is possible that there are Aspergillus specific VOCs in the breath of     patients with IA.      The composition of the lung microbiome seems to be an important factor in both health and     disease. It is likely that the microbiome of the lung changes in prolonged neutropenia,     therefore possibly creating a niche for molds and yeasts. Comparing the microbiome of     patients with prolonged neutropenia who develop IA with those who do not, can learn us more     about the pathogenesis of this disease. This knowledge could be used to investigate new     treatment options for Invasive Aspergillosis.      Hypothesis The investigators hypothesize that airway microbial (viral, bacterial) presence     and exhaled molecular profiles as obtained from patients with prolonged neutropenia due to     treatment of hematological malignancies, are different between patients who develop IA and     patients who do not.   "
90147|NCT02106104|"     The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4     inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.   "
90148|NCT02106091|"     The purpose of this study is to determine whether AFM11 is safe and active in the treatment     of relapsed and/or refractory Non-Hodgkin Lymphoma (NHL).   "
90149|NCT02106078|"     The investigators hope to learn whether access to online support and education can help     people with Bipolar Disorder (BD) better manage their symptoms of depression.   "
90150|NCT02106065|"     The purpose of this study is to study the effects of an education and skill-building     intervention on family caregivers of Veterans with dementia.   "
90230|NCT02105025|"     Colonoscopy is the current common method for management of colorectal diseases, and     effectiveness of colonoscopy associate with complication rate. A lot of patients were failed     because of technical difficulty, those required more than 10 min to intubate the cecum are     consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may     be required for a successful colonoscopy. Thus, it is important to set up a clinical model to     predict the technical difficulty of the examination in preoperational stage.   "
90151|NCT02106052|"     Cognitive impairment affects roughly 50% of people with multiple sclerosis (MS). There are     currently no satisfactory medical treatments for cognitive impairments related to MS and     alternative forms of treatment are needed. Exercise training can improve cognition in older     adults and people with mild cognitive impairments, including those with early Alzheimer's     disease. Therefore, the investigators plan to conduct the first definitive study that will     test the theory that moderately intense aerobic exercise can improve cognition in people with     MS-related impairment - specifically in information processing speed - more so than     non-aerobic stretching and toning (both forms of exercise will be performed 3 days per week     for 6 months).      Primary study hypothesis: The investigators hypothesize greater improvement in speed of     information processing from pre- to post-treatment in the aerobic exercise group compared to     the stretching and toning group (attention control).      Secondary study hypothesis: The investigators hypothesize greater improvement in other     cognitive domains and patient reported outcomes from pre- to post-testing in the aerobic     exercise group compared to the stretching and toning group (attention control).      The investigators plan to recruit 125 adults with MS who can walk without assistance and     without rest for at least 100 meters and have mild weaknesses in information processing     speed. The investigators will randomly assign 50% of participants to an aerobic exercise     program and 50% to a non-aerobic exercise program (stretching and toning). In order to     determine whether the intervention is successful, the investigators will compare cognitive     functioning in both exercise groups before the exercise-training program, at the end of the     6-month training program and three months after the end of the training program. If our study     findings support our hypotheses, this would be a relatively no-barriers treatment option to     further explore for other people with MS including people with greater and lesser baseline     disability.   "
90152|NCT02106039|"     The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of     diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis-     diabetes patients.   "
90153|NCT02106026|"     An antenatal education intervention in primiparous women improves breastfeeding duration and     reduces post-natal complications.   "
90154|NCT02106013|"     This is a study of HDL function in healthy individuals classified in three groups according     to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the     purpose of investigating which characteristics of the HDL particle might be associated to     atherosclerotic burden, characterized by carotid intima-media thickness above 1mm.   "
93727|NCT02059278|"     This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both     eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84     days in patients with elevated eye pressure.   "
90155|NCT02106000|"     The purpose of this study is to record and compare the inhalation profiles of non pregnant     women and those who are in the third stage of labour. The inhalation profiles will be     recorded from consenting women as they inhale with maximal effort through an inhalation     profile recorder [Glaxosmithkline (GSK), Ware]. The recorder will simulate resistance to     airflow and will be representative of a dry powder inhaler of moderate resistivity. The     inhalation endpoints will include Peak Pressure Drop, Peak Inspiratory Flow Rate, Inhaled     Volume, Inhalation time, Average Inhalation Flow Rate and Acceleration rate which will be     compared between the two female cohorts. Inhalation profiles recorded in this way may     subsequently be used to study the in-vitro performance of investigational materials across     inhalation parameters representative of the target patient population.      An appropriate number of subjects will be consented so that approximately 40 subjects (20     non-pregnant females and 20 stage three labour subjects) complete assessments. The inhalation     profiles will be recorded on the same day of screening or at another time within a span of 50     days   "
90156|NCT02105987|"     This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled,     multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the     non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams     (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared     with continuing the subject's current suppressive regimen through 24 weeks. The study will be     conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected individuals     who are on stable suppressive combination antiretroviral therapy (cART) with 2 Nucleoside     reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI), an     non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI).     Eligible subjects will be randomly assigned 1:1 to continue their current regimen     (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects)     once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue     their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24     weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that     treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted     at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well     as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and     tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir     (FPV/r) or tipranavir/ritonavir (TPV/r).   "
90157|NCT02105974|"     This is a Phase IIIa, multicenter, randomized, stratified (reversibility status),     double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25     micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via     the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on     lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100     mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and     the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD.     ELLIPTA™ is a registered trademark of GlaxoSmithKline.   "
90158|NCT02105961|"     This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial     evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous     (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar     levels as those seen in severe asthmatics. It is hypothesized that the reduction of     eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD     exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects     who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who     exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD     subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in     1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The     total duration of subject participation will be approximately 62 weeks, consisting of a 1 to     2 week screening period, 52-week treatment period and 8-week follow-up period.   "
90202|NCT02105389|"     Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving     treatment for cancer, and intensively treated patients may be at higher risk. While exercise     is an effective intervention for CRF, patients receiving the most intensive chemotherapy may     frequently be too ill to participate in a standardized exercise program. A unique     intervention that combines exercise and relaxation is yoga. This pilot study will evaluate     the feasibility of three times weekly yoga sessions administered by a trained yoga instructor     for a three week duration and will enroll between 10 and 20 children. If feasible, the     intervention will be tested in a randomized controlled trial.   "
90159|NCT02105948|"     This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial     evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC)     injection.      In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in     severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in     COPD patients would translate into a reduction of COPD exacerbations. The study will     determine the reduction in exacerbations in subjects who are above and below the baseline     blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the     efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in     COPD subjects at high risk of exacerbations, despite the use of optimized standard of care     background therapy.      Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive     placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study     will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week     treatment period and 8-week follow-up period.   "
90160|NCT02105935|"     This study's objectives are:        -  To prospectively examine changes in brain network activation (BNA™) from baseline to          recovery (i.e., return to activity) in youth and adolescent athletes with concussion.        -  To assess the clinical utility of changes in BNA to assist in clinical decision-making.        -  To generate normative BNA data.   "
90559|NCT02100735|"     The purpose of this study is to evaluate how the investigators provide sedation (medicine     that make you sleepy) in the investigators intensive care unit (ICU). This study will look at     a new way of using sedation in the ICU to see what effect it has on patients and if it     decreases the amount of time spent on mechanical ventilation (machine that breathes for you),     and in the ICU.   "
90161|NCT02105922|"     From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:      HRTW: Heavy Strength Training x3/week & 20g whey protein twice daily. LITW: Light Intensity     Training x3-5/week & 20g whey protein twice daily. WHEY: 20g whey protein twice daily.      15 subjects from each group will be recruited and tested after 3 months of intervention.     Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size,     cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c.     Tests are to be compared with Project ID NCT01997320.   "
90162|NCT02105909|"     This is a GWAS pilot study that aims to identified possible candidate genes associate to     obesity by exploring single nucleotide polymorphism (SNP) in a small group of obese ,     metabolically healthy white adults, matched with lean, white adults , metabolically healthy.     The investigators hypothesize that the careful phenotyping of the subject sand matching with     increase the power to find SNP significantly associate with obesity (as defined by BMI).   "
90163|NCT02105896|"     Purpose: To evaluate the performance of several dental adhesives used for bonding     tooth-colored fillings to teeth 6 years after the fillings have been placed.      Participants: Subjects which had participated in the study entitled Clinical Evaluation of     New Total-Etch and Self-Etch Dental Adhesives (IRB Study #07-0673).      Procedures (methods): Fillings that had been placed 6 years ago will be evaluated by a     direct, visual examination. Close-up intra-oral clinical photographs of each filling will be     made. An impression of the filling may be obtained.      The specific study aim of this 6-year recall of the patients treated in IRB Study #07-0673 is     to evaluate the fillings placed according to the following characteristics: Retention; Color     match; Cavosurface margin discoloration; Secondary caries; Anatomic form; Marginal adaptation     and/or integrity; Post-operative sensitivity.   "
90164|NCT02105883|"     The purpose of this study is to evaluate if the use of identification badge (role and place)     during high-fidelity simulation as an impact on situation awareness.   "
90165|NCT02105870|"     Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients     suffering an acute myocardial infarction.      The investigators hypothesise that treatment with intracoronary abciximab, a potent anti     platelet agent, at the time of coronary stent insertion, will improve microvascular function.   "
90166|NCT02105857|"     The purpose of the study is to find the best way to mobilize a knee after total knee     arthroplasty (TKA). In particular, the aim of this study will be to investigate the     advantages of adding a gentle knee mobilization to the standard rehabilitation used by     physiotherapists in this hospital after TKA.      All individuals waiting for TKA from the Departement de l'appareill Locomoteur (DAL) -     Centre Hospitalier Universitaire Vaudoise (CHUV) will be considered for this research trial.     The number of individuals necessary to complete this study is 32.      Participants deciding to take part will be given an information sheet and asked to sign a     consent form. If deciding to take part, they will still be free to withdraw at any time and     without giving a reason. A decision to withdraw at any time, or a decision not to take part,     will not affect the standard of care they receive.      People who agree to take part will be randomly selected into 2 groups: one group will follow     the standard treatment used in physiotherapy after TKA, the other group will have the same     treatment and the technique of A+ mobilization in investigation added. Participants have 50%     chances to be allocated to either of the groups. Before surgery, at the first and seventh day     after operation, the researchers will measure the range of motion (ROM) of the replaced knee.     This means that the study will last till the moment the last participant leaves the DAL -     CHUV, which is estimated to be in 12 months after the first recruitment.      Individuals over 18 years old undergoing unilateral primary TKA caused by osteoarthritis will     included. Exclusion criteria will be: a) insufficient French language skills to agree a     written consent, b) body mass index (BMI) >40 kg/m2, c) symptomatic OA in the contralateral     knee (defined as self-reported knee pain >4 on a 10-point verbal analogue scale), d) other     lower extremity orthopedic problems limiting function, e) neurologic impairment or g)     cognitive dysfunction.      No life-style restrictions will be requested. Patients will just need to follow the     physiotherapist's usual advices during the in-hospital period at the DAL - CHUV. This study     does not alter the standard procedures, patients will receive all the techniques used in     physiotherapy as every other TKA patient. If allocated into the mobilization group, a     specific knee splint will be positioned on the patient's knee. This position will be held for     20 minutes with the leg straight and 20 minutes bent, twice a day. The person in charge of     these procedures is the principal investigator of the study, a certified orthopedic     physiotherapist on the staff of the DAL - CHUV. No additional changes to patients' daily     routine will be involved.      To the investigators knowledge, there are no side effects due to use of this mobilization.     Nevertheless, the pain levels of every patient will be recorded to identify any differences     between groups. If, during or after the clinical study, any patient will face unexpected     health problems related with the study, they will be kindly asked to transmit the information     to the principal investigator of the study. The mobilization technique involves no additional     risk over that of standard treatment performed in the hospital. This study hypothesis that     adding A+ graded mobilization combined with the standard in-hospital rehabilitation protocol     will improve ROM without increasing pain.      All information collected will be kept strictly confidential. Any information used will have     names and addresses removed. All data will be stored, analyzed and reported in compliance     with the Data Protection Legislation of Switzerland.   "
90167|NCT02105844|"     Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall,     2600 patients with documented atrial fibrillation aged >65 years will be included and     followed on a yearly basis.      Yearly clinical examinations include a detailed questionnaire on personal characteristics, a     resting electrocardiogram, neurocognitive function tests and questionnaires on disability and     quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at     baseline and after 2 years of follow-up.      The main study aims of this long term prospective study are to increase our knowledge on     structural brain damage and its changes over time in patients with atrial fibrillation, to     gain additional insights on the incidence and underlying mechanisms of cognitive decline in     patients with atrial fibrillation and to evaluate the interrelationships of structural and     functional brain damage in this population.   "
90168|NCT02105831|"     Advanced heart failure (when the heart pump fails) is associated with symptoms such as     shortness of breath and extreme fatigue. Some of these symptoms are simply due to failure of     the pump, however abnormal regulation of blood flow to the muscles of the body is also a     potential mechanism. Left ventricular assist devices are mechanical pumps used to compensate     for patients with failing hearts either as a bridge to heart transplant or as long term     therapy. Whether or not these pumps improve muscle flow and whether this is a determinant in     the improvement of symptoms is unknown. Understanding how skeletal muscle and heart perfusion     is altered in heart failure patients before and after implantation of an LVAD could provide     further insight into the beneficial effects of this therapy.      Specific Aims:        1. To evaluate skeletal muscle and heart perfusion studies before and after LVAD          implantation        2. To compare functional status with degree of skeletal muscle perfusion.   "
90169|NCT02105818|"     The purpose of this study is the validation of a newly developed self-report questionnaire     which aims at determining the prevalence, location and intensity of SWAllowing difficulties     with drug intake, and describing the impact on MEdication regimen focusing on COping     strategies (SWAMECO).   "
90170|NCT02105805|"     30 obese moderate-to-severe heart failure patients will be randomized to intervention or     control in groups of 5-10 subjects.      All will receive dietetic advice according to randomization and according to the European     Heart Association.      Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula     diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d     substituting two daily meals with formula meal replacement.      Control subjects are advised to follow the Nordic Nutrition Recommendations.      Patients will be monitored by blood sampling and assessed by change in physical performance.   "
90173|NCT02105766|"     Background:      - Some sickle cell disease or beta-thalassemia can be cured with transplant. Researchers want     to test a variation of transplant that uses low dose radiation and a combination of     immunosuppressive drugs. They want to know if it helps a body to better accept donor stem     cells.      Objectives:      - To see if low dose radiation (300 rads), oral cyclophosphamide, pentostatin, and sirolimus     help a body to better accept donor stem cells.      Eligibility:      - People 16 and older with beta-thalassemia or sickle cell disease that can be cured with     transplant, and their donors.      Design:        -  Participants and donors will be screened with medical history, physical exam, blood          test, tissue and blood typing, and bone marrow sampling. They will visit a social          worker.        -  Donors:        -  may receive an intravenous (IV) tube in their groin vein.        -  will receive a drug injection daily for 5 or 6 days to move the blood stem cells from          the bone marrow into general blood circulation.        -  will undergo apheresis: an IV is put into a vein in each arm. Blood is taken from one          arm, a machine removes the white blood cells that contain blood stem cells, and the rest          is returned through the other arm.        -  Participants:        -  may undergo red cell exchange procedure.        -  will remain in the hospital for about 30 days.        -  will receive a large IV line that can stay in their body from transplant through          recovery.        -  will receive a dose of radiation, and transplant related drugs by mouth or IV.        -  will receive blood stem cells over 8 hours by IV.        -  will take neuropsychological tests and may complete questionnaires throughout the          transplant process.        -  must stay near NIH for 4 months. They will visit the outpatient clinic weekly.        -  will have 5 follow-up visits for 3 years after transplant, then annually.   "
90560|NCT02100722|"     The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary     pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided     percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease     (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).   "
90174|NCT02105753|"     Primary axillary hyperhidrosis is a common idiopathic disorder of the eccrine sweat glands     that interferes with daily activities and causes significant social distress. This pilot     study is designed to evaluate the efficacy and histologic effects of the 1210nm diode laser     for the treatment of axillary hyperhidrosis. Initial results may inform the design of an     anticipated larger prospective controlled trial. Study participants will receive one laser     treatment to one randomly-assigned axilla using the 1210 nm diode laser, and two treatments     to the opposite axilla. Changes in sweating will be measured both by quantitative gravimetric     analysis of sweat production and by expert panel evaluation of photographs of the     starch-iodine test performed on each axilla. Participants will also be asked to subjectively     classify the severity of their axillary sweating. These measures will be performed at     pretreatment and at one, three, and six months following treatment. Biopsies of both axillae     will be done before and two weeks after treatment to assess histologic changes to the eccrine     gland and surrounding structures. Treatment of axillary hyperhidrosis with the 1210nm diode     laser is a novel approach based on the unique absorption characteristics of this wavelength.     We hypothesize that selective heating of lipids at the appropriate tissue level will impact     adjacent eccrine glands typically seated at the dermo-hypodermal junction, leading to     subjective and/or objective decreases in eccrine secretions. This type of treatment may offer     an effective, non-invasive and safe alternative to current treatment modalities.   "
90175|NCT02105740|"     The aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients,     to reduce the level of pain, anxiety and depression. The comparison was made through the     scores on the Visual Analogue Scale (VAS) and the Hospital Anxiety and Depression Scale     (HADS).   "
90176|NCT02105727|"     The objective of this study is to determine whether a community-based salt reduction program     can reduce average salt consumption levels. Baseline levels of salt consumption were measured     in 2011, the salt reduction program was then implemented, and now in 2014 investigators are     remeasuring salt consumption levels in the community. The hypothesis investigators are     testing is that the salt reduction program will have led to a change in salt consumption     levels between 2011 and 2014. The study is being done in Lithgow, a regional town in New     South Wales , Australia.   "
90177|NCT02105714|"     NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded     by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system     for delivering primary health care in resource-constrained settings. NIDIAG will investigate     three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever     and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current     study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal     pain that last for at least 2 weeks.      While acute diarrhoea has been studied globally, few research activities have focused on the     epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and     longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30     bacterial, parasitic and viral infectious agents. This lack of data may be explained by the     fact that people suffering from NTDs might only seek care at a late stage of the disease.     Furthermore, health systems in affected regions are often weak and their primary health-care     centres are often under-staffed and lack essential diagnostic equipment.      The hypothesis of this study is that development of an evidence-based syndromic approach can     lead to better diagnosis and management of NTDs in patients with persistent digestive     disorders. The study will be carried out in two West African countries (Côte d'Ivoire and     Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a     case-control design and patients and controls will be prospectively enrolled. In order to     address the knowledge gaps, three specific objectives will be pursued. First, the     contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed.     Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of     target NTDs that give rise to persistent digestive disorders will be determined. Third, the     clinical response to standard empiric and targeted treatment of several NTDs in patients with     persistent digestive disorders will be evaluated. These objectives will provide a long-term     benefit for the communities by improving the clinical decision-making process for the target     NTDs and thus, better diagnostic work-up and patient management can be achieved in the study     countries and other similar resource-constrained countries   "
90178|NCT02105701|"     This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir     (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus     (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated     interferon and RBV. The primary study hypothesis is that in at least one of the study arms,     the percentage of participants achieving sustained viral response 12 weeks after the end of     all study treatment (SVR12) will be superior to 58%.   "
90179|NCT02105688|"     This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of     grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the     treatment of chronic HCV GT1, GT4, or GT6 infection in treatment-naïve participants who are     on opiate substitution therapy (OST). The primary hypothesis is that the percentage of     participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate     Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study     therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1     dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a     3-year observational follow-up.   "
90180|NCT02105675|"     The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care     therapy can improve survival times for patients with Metastatic Castration Resistant Prostate     Cancer   "
90181|NCT02105662|"     The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100     mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus     (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The     primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir     and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater     than 70%.   "
90205|NCT02105350|"     This is a phase I study (an early study to check the safety of a new drug or drug     combination) to find the safest and most tolerated dose of the combination of oxaliplatin     with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers     and cancers associated with the bile ducts leading from the gallbladder and to and from the     liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where     cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine     but may receive different doses of MEK 162.      MEK 162 is a new drug which plays an important role in the regulation of cell growth and has     been shown to shrink tumours in patients with biliary cancer and other types of human     cancers. This type of drug has also been shown to shrink tumours when given in combination     with cisplatin and gemcitabine in research studies done in animals and in some patients with     biliary cancer.   "
90185|NCT02105610|"     There is initial evidence that the choice of anesthesia can influence survival in the     specific setting of coronary artery bypass grafting surgery (CABG).      A recent international consensus conference included volatile agents among the few     drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and     that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane)     have non-anesthetic pharmacological characteristics that confer cardiac protection when     compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were     summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin     release and mortality in patients receiving volatile anesthetics when compared to patients     receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al.     2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can     translate into a reduced mortality rate in patients receiving volatile agents. The level of     evidence for these four studies is not high (one meta-regression, one underpowered randomized     controlled study, one retrospective study and one meta-analysis of small randomized studies)     and there is need for a large multicentre randomized controlled study to confirm these     findings, as suggested by the international consensus conference on this topic published in     2011 (Landoni et al 2011).      The purpose is to provide a large multicentre controlled randomized trial to demonstrate that     volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG     (either with or without cardiopulmonary bypass).      The results of this study can support the use of volatile agents in all CABG procedures     worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis     that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be     reduced from 3% to 2% using volatile agents).   "
90186|NCT02105597|"     Background: Diabetes mellitus (DM) is a major cause of morbidity and mortality worldwide.     Long-term glycemic control is important to prevent or delay the onset of DM related     complications. Patients often fail to achieve optimal glycemic control from pharmacotherapy     due to non-adherence. With the high prevalence of smartphone usage locally and among the     developed countries, there has been a growing interest to deliver interventions through     mobile applications. In this study, a mobile application targeted at improving medication     adherence among people with Type 2 DM will be developed and evaluated.      Aims: This study aims to (i) design a smartphone application to improve medication adherence     and (ii) evaluate its impact on clinical outcomes, health-related quality of life (HRQoL) and     health status among patients with Type 2 DM.      Hypothesis: The use of a smartphone application can improve medication adherence among     patients with Type 2 DM, as well as clinical outcomes, HRQoL and health status.      Methods: This is a randomized, open-label controlled trial involving patients with Type 2 DM     managed at Singapore General Hospital. Patients seen at the institution's Diabetes Centre and     those referred to the pharmacist-led Medication Therapy Management service are eligible to     participate. Patients in the intervention group will have the mobile application downloaded     onto their smartphones, while those in the control group will receive the usual standard of     care. The primary outcome will be change in self-reported medication adherence, determined     using the 8-item Morisky Medication Adherence Scale. Secondary outcomes include change in     HbA1c, blood glucose, frequency of dose titrations, addition or removal of oral hypoglycemic     agents, HRQoL (measured using the Audit of Diabetes Dependent Quality of Life) and health     status (measured using the EuroQol-5D-5L and EuroQol Visual Analogue Scale). All outcomes     will be measured at baseline and at the end of the 6-month study period (± 4 weeks).      Significance: The development and evaluation of a mobile application to improve adherence     among patients with Type 2 DM in Singapore is the first of its kind, and the findings of this     study will provide the much-needed evidence to demonstrate the effectiveness of this     intervention.   "
90187|NCT02105584|"     This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA     occluder indicated for percutaneous LAA closure in adult male or female patients with atrial     fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year     following implantation of an Occlutech® LAA Occluder.   "
90188|NCT02105571|"     The current project is a randomized, controlled evaluation of a new weight loss and health     promotion intervention for truck drivers. The intervention is a 6-month weight loss     competition supported with computer based training, behavioral self-monitoring, and     motivational interviewing. We hypothesize that the intervention will produce greater change     than a usual practices control condition. Our secondary hypothesis is that social support and     stress in home and work environments will moderate intervention efficacy.   "
90189|NCT02105558|"     To compare the effects of epidural versus CSE anesthesia on the success of TOLAC. This will     be a prospective clinical study randomizing 60 eligible women into either an epidural group     or CSE group. The effects of the specific regional anesthetic on patient's individual labor     efforts will then be closely monitored. Written informed consent shall be obtained to enroll     the patients in either group. Pain scores and electronic medical record information will be     used with non-identifiable coding to determine the resulting outcomes.   "
90190|NCT02105545|"     The goal of this study is to develop a new, local system that will use special tests based on     patients' genetic makeup to better tailor cancer care at the University of New Mexico Cancer     Center.      The Food and Drug Administration has already approved over forty (40) drugs to treat cancer     patients based on specific genetic makeup, and more agents are in development that will     support this new approach to treatment, often referred to as personalized medicine.      The goal of performing specific tests on patients' genetic material is to discover     tumor-specific, single nucleotide variations (SNVs) and other forms of genetic changes     (called epigenetic changes) that can be detected when comparing normal tissue and tumor     tissue. This can help guide cancer care decisions that may be more effective for patients.     These will be called clinically actionable findings, or CAF.      Additional health related findings may be made, not related to cancer but to other     conditions, diseases or syndromes. These are called secondary findings (SF). In this study     the investigators will also measure how often they find SF and will discuss their possible     impact on other aspects of patients' health. If patients want to know about these findings,     they will be discussed with a panel of experts including genetic counselors.      Finally, the investigators will compare how often CAF and SF differ from those identified in     nationwide samples.   "
90191|NCT02105532|"     Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell     (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal     Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised     controlled trial.   "
90192|NCT02105519|"     In recent years, several studies revealed that the current influenza vaccine strategy might     be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and     mortality in the end-stage renal disease population than previously thought. Thus, this also     raised the question about the effectiveness of administration of influenza vaccination in     chronic kidney disease patients not on dialysis. In this study, the investigators aim to     evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in     patients with different stage of chronic kidney disease (CKD) not on dialysis.   "
90203|NCT02105376|"     This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as     primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on     depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items     (HDRS-17) in patients with moderate / severe depressive episode.   "
90231|NCT02105012|"     Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD     MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent     asthma.   "
90193|NCT02105506|"     Rationale: The construction of esophageal anastomoses is associated with considerable risk at     postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human     fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially     prevent anastomotic leakage.      Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal     anastomoses.      Study design: Non-randomized, non-blinded, single-center intervention study. Study     population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an     esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be     enrolled. A total number of 15 patients will be included in the study.      Intervention: Gastric or esophageal resection will be executed according to the common     procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all     enrolled participants will receive a TachoSil® patch, which will be applied on the esophageal     anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy. TachoSil® will     be degraded enzymatically in a period of approximately 24 weeks after application.      Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by     evaluation of adherence of the patch. A time-action analysis of the application of the     Tachosil patch will be performed.      Nature and extent of the burden associated with participation: The burden for the patient is     minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative     care and outpatient visits do not differ from regular protocol. TachoSil® is approved and     registered for supportive treatment in surgery for improvement of haemostasis and to promote     tissue sealing by the European Commission.   "
90194|NCT02105493|"     Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade.     However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial     access and potentially limits the radial artery as an access site in the future. Several     strategies have been used to decrease the incidence of RAO including the use of     anticoagulation, maintenance of patency during hemostasis, or shortening the duration of     compression. Currently, there is no data whether vasoactive pharmacological therapy such as     nitroglycerin administered intra-arterially at the end of the procedure may reduce the     incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor)     at the end of a TRA procedure may reduce the incidence of RAO.   "
90195|NCT02105480|"     The purpose of this double-blind pivotal clinical utility study is to determine on a large     patient population whether heart murmurs can be reliably detected with high sensitivity and     specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred     to as computer aided auscultation (CAA)).      Each patient is auscultated and diagnosed independently by a medical specialist.     Additionally, for each patient, an echocardiogram is performed as the gold-standard for     determining heart pathologies. The CAA results are compared to the findings of the medical     professionals as well as to the echocardiogram findings.      Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically     diagnose pathological heart murmurs in premature babies and newborns with at least the same     accuracy as experienced medical specialists.   "
90196|NCT02105467|"     This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir     (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT)     1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment     or deferred treatment (placebo control). The primary efficacy hypothesis was that the     proportion of participants receiving combination therapy in the Immediate Treatment Arm who     achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is     superior to 73%.   "
90197|NCT02105454|"     In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior     direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742)     + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.   "
90198|NCT02105441|"     Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit     from cochlear implantation on the worst hearing side.   "
90199|NCT02105428|"     A goal of this study is to use a novel methodology to determine whether insulin resistance in     women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with     modifications. This could lead to future research to determine if these modifications     interfere with their proper function. Additionally, the investigators will determine how     protein quality is affected by exercise training. Aerobic exercise enhances the endogenous     oxidant buffering systems which may minimize oxidative damage to proteins. The investigators     propose that aerobic exercise minimizes the accrual of modified proteins by increasing the     synthesis of new proteins, but also by increasing the degradation and removal of old and     damaged proteins. Based on our previous studies the investigators observed that insulin     affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only     in muscle but also in liver. The investigators therefore propose that aerobic exercise and     related increase in insulin sensitivity (and decline in insulin levels) will reduce     accumulation of old and modified skeletal muscle and plasma proteins leading to improved     function.   "
90200|NCT02105415|"     The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable     hemodynamics as compared to Etomidate during emergent intubations in the intensive care unit.     Patients that require a breathing tube to be placed in the ICU will be randomized to receIve     either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the     breathing tube.   "
90201|NCT02105402|"     The purpose of this study is to carry out a high-level treatment efficacy study on children     with speech sound disorders with motor speech involvement (SSD-MSI) using a well-controlled     Randomized Controlled Trial design.      The intervention of choice is the Prompts for Restructuring Oral Muscular Phonetic Targets     (PROMPT) approach, which has been effective in treating motor speech disorders in adults and     in children with autism and cerebral palsy.   "
90204|NCT02105363|"     The investigators want to determine how much the skin on the back can move left to right of     the midline and also up and down, in subjects presenting for procedure or in healthy     volunteers. The investigators will do measurements on the back using samples of individuals     in all age groups.      It is hypothesized that an explanation to late epidural failure could be related to excess     back motion in individual subjects.   "
90206|NCT02105337|"     The purpose of this study is to determine if a clear barrier placed over the eyes has any     effect on goggle monitoring. When a patient has general anesthesia they lose the ability to     blink and their eyes may dry. They may also lose the ability to keep their eyes fully closed.     The anesthesiologist takes several steps to prevent injury to the eyes. First the eyes will     be lubricated with ointment and the eyelids will be held in a closed position by the use of a     clear barrier. During pituitary surgery it is the routine practice to perform many types of     monitoring. One type of monitoring is to stimulate your eyes with a light. This helps your     surgeon protect the nerve supply to your eyes. The light is supplied by a pair of goggles     placed over your eyes during surgery.      To help achieve our objective, the investigators are asking patients who are undergoing     pituitary surgery to give us permission to record two sets of numbers form the monitoring     device once prior to the application of the clear barrier and the second after the barrier is     applied. This will be done when the patient is already asleep and will not be aware this is     happening.   "
90207|NCT02105324|"     This study will test the hypothesis that a wearable automated bionic pancreas system that     automatically delivers both insulin and glucagon can improve glycemic control vs. usual care     for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.   "
90208|NCT02105311|"     The investigators conduct this study to access the effect of selective laser trabeculoplasty     on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension     glaucoma and ocular hypertension. This treatment effect is compared with that of the     prostaglandin analogue, travoprost.   "
90209|NCT02105298|"     Intraoperative intravenous fluid management practice varies greatly between     anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity.     Postoperative respiratory complications are associated with increased morbidity, mortality     and hospital costs. The literature shows conflicting data regarding intraoperative fluid     resuscitation volume. No large-scale studies have focused on intraoperative fluid management     and postoperative respiratory dysfunction.      Hypotheses:      Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of     30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with     increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation,     atelectasis, acute kidney injury and peri-extubation oxygen desaturation.   "
90210|NCT02105285|"     The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic     solution in comparison with carteolol long-acting ophthalmic solution in subjects who are     insufficiently responsive to carteolol long-acting ophthalmic solution.   "
90211|NCT02105272|"     The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic     solution in comparison with latanoprost ophthalmic solution in subjects who are     insufficiently responsive to latanoprost ophthalmic solution.   "
90212|NCT02105259|"     The overall aim of this study is to develop and test a psychodynamic Internet--delivered     psychological treatment for patients with social anxiety disorder and compare its efficacy to     a waiting list.   "
90213|NCT02105246|"     The long-term goal of this research is to improve patient-centered outcomes in patients with     coronary heart disease (CHD). CHD is the leading cause of death in the world. Exercise-based     cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in     patients with CHD. Published guidelines recommend exercise-based CR following hospitalization     for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary     revascularization, and referral to CR is one of nine performance measures established by the     American Heart Association and American College of Cardiology for patients with CHD.      Despite these compelling benefits, CR programs are vastly underutilized, with less than a     third of eligible patients participating. The largest barrier to patient participation is     that CR must be provided in a physician's office or hospital setting to qualify for     reimbursement. For this reason, virtually all existing CR programs require that the patient     travel to a CR center 3 times per week for 12 to 36 weeks. Unfortunately, many Americans live     too far from a CR center to enroll, and even when nearby programs are available, many     patients do not have the time, flexibility, transportation, social support, and/or financial     resources to attend.      One promising solution to the problem of CR under-utilization is greater implementation of     home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular     risk factors and quality of life. However, similar efficacy does not necessarily translate     into similar effectiveness. If patients are more likely to participate in home- vs.     center-based therapy, then greater participation could lead to greater clinical     effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA     medical centers to determine the comparative effectiveness of referral to home- vs.     center-based CR in patients with CHD.      Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient     participation in CR after hospitalization for myocardial infarction or coronary     revascularization.      Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs.     centerbased CR on six-minute walk distance, quality of life, and healthcare expenditures.      Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race,     ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient     preference.      Results from this study will (a) help policy makers determine the effect of covering home CR     on healthcare expenditures in patients with CHD; (b) help providers understand the potential     benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like,     Given my personal circumstances and preferences, which of these options will improve the     outcomes most important to me.   "
90225|NCT02105090|"     The purpose of this study is to examine in prospective, double-blinded randomised manner the     ability of novel articaine-containing lozenge to enhance the procedure related compliance     (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.   "
90226|NCT02105077|"     The purpose of this study is to establish a laboratory method to determine from blood samples     whether a person has been treated with xenon.   "
90227|NCT02105064|"     This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms     in patients with schizophrenia.   "
90228|NCT02105051|"     The purpose of this study is to establish Chinese neonatal network to investigate current     situation of neonatal birth weight and related factors. We investigated the risk factors such     as sex, gestational age, region, nation, altitude, place of residence, maternal occupation,     education level of mother, maternal age, maternal pregnancy diseases and multiple births.   "
90235|NCT02104960|"     This study aims to evaluate skin aging of an homogeneous population of 77 years old patient     selected among the PROOF cohort who has been continuously investigated by cardiological     examination.      Skin aging will be explored by macroscopic and microscopic evaluation. In particular, skin     aging will be measured by an index of clinical aging (SCINEXA) and other complementary     measures such as facial photos, standard and High Definition dermoscopy, elastography,     sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.   "
90236|NCT02104947|"     Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g     idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or     require emergency surgery or procedures.   "
90214|NCT02105233|"     Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains     unfavourable. Tools for improving brain tumor surgery, in particular for gliomas, are     increasing. There seems to be an agreement that achieving extensive resections, when done     safely without jeopardizing neurological function, improves survival.      Ultrasound is currently used as a tool for providing 2D or 3D images for the purpose of tumor     localization and resection control. For the use in resection control the resection cavity is     filled with saline to provide acoustic coupling between the ultrasound transducer and tissue.     However, attenuation of acoustic waves is very low in saline compared to the brain and this     difference in attenuation is the cause of artifacts that may severely degrade the ultrasound     images. Such artifacts are seen as high-intensity signal at the resection cavity wall and     beyond, potentially masking small tumor remnants and generally making the interpretation of     images more difficult.      This research group has developed an acoustic fluid intended for use in the resection cavity     instead of saline. Tests in laboratory measurements have shown that the fluid reduces     artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery.     The investigators expect that the acoustic fluid will make it easier to detect small tumor     remnants near the end of an operation, thus increasing success of glioma surgery. The purpose     of this study is to test the fluid during surgery for histopathologically proven glioblastoma     to assess safety and efficacy.   "
90215|NCT02105220|"     The goal of this study is to describe the influence of the chest wall on the respiratory     system mechanics in morbidly obese patients and in patients with high intra-abdominal     pressure.      The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest     wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated,     both during controlled and assisted mechanical ventilation.      Patients will be studied, first, during the acute phase of respiratory failure, when     requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated     again during weaning from the ventilator to assess the influence of PEEP in assisted     ventilation prior to extubation.   "
90216|NCT02105207|"     For patients presenting to the Emergency Department with acute dyspnea, emergency physicians     will be asked to categorize the diagnosis as acute decompensated heart failure or     non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after     performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic     peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in     the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea     will be determined by independent review of the entire medical records performed by two     emergency physicians. In case of disagreement, a third expert physician will review entire     medical records, and adjudicate the case.   "
90217|NCT02105194|"     Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression     illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging     tracks and is consistent with the clinical condition of the patients.   "
90218|NCT02105181|"     Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or     plastic stent placement are currently the most popular techniques. Partially covered     self-expandable metallic stents have also shown to be effective but can be difficult to     remove. A novel fully covered metallic stent has recently been developed.      The aim of this study was to prospectively evaluate the placement of fully covered     self-expandable metallic stents (FCSEMS) in this setting.   "
90219|NCT02105168|"     Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as     chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of     why those patients are relapsing using next generation sequencing to identify rare mutations     and assessed their predictive value.   "
90220|NCT02105155|"     The best period for the conversion from Prograf (tacrolimus administered twice daily) to     Advagraf (once-daily prolonged-release tacrolimus) remains unknown. The aim of this     prospective, randomized, multicenter trial is to prove the non-inferiority of the early     conversion (at D7) versus the conversion at D90 after liver transplantation. The primary     objective will be to evaluate the incidence of a first biopsy-proven acute rejection in the 6     first months, and prove the non-inferiority of the conversion at D7 + / - 3 versus the     conversion at D90 + / - 5 (reference group). If non-inferiority is proved, the two strategies     will be compared in terms of superiority. 250 patients will be included. Three ancillary     studies will be added : a PK study in a subgroup of 40 patients (20 patients per arm), an     assay of the calcineurin activity on a subgroup of 40 patients, and a medicoeconomic study in     all patients   "
90221|NCT02105142|"     Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder     of childhood, affecting approximately 8% of youth. Children with ADHD often have problems     sustaining attention and completing multi-step commands and tasks of daily living, such as     homework. Pediatricians are often the first physicians to identify problems with children's     functioning at home and at school. However, because of limited visit time, pediatricians     often struggle with managing ADHD while trying to also cover a vast array of other primary     care issues. Moreover, as there is a nationwide shortage of pediatric mental health     specialists and access to parenting programs is limited, a critical need exists to develop     interventions that form partnerships between behavioral and mental health specialists and the     primary care pediatrician. One approach is to base interventions in the pediatric clinic to     ensure children have access to appropriate treatment. Thus far, only a limited number of     sites have this pediatric-mental health partnership.      Health information technology (HIT) has been used to enhance primary care management of ADHD.     HIT can improve pediatricians' ability not only to adhere to recommended guidelines, but also     to screen for co-existing disorders and provide timely parental education. An alternative     strategy might be to use group visits (GV). GV afford more time with families and allows the     pediatrician to facilitate more in-depth discussions. More importantly, the group model     allows parents to learn from one another, normalizes parenting expectations, and addresses     shared experiences of medication side effects and other factors related to adherence.     Moreover, a group visit can be conducted in a physical location, such as the pediatric     clinic, or be brought into the virtual world with the aid of social media. Virtual support     groups for chronic care diseases have become an increasingly popular way for a community of     individuals to exchange information and offer emotional support.      Prior to the adoption of these interventions into primary care practice, investigators must     know which is best. Rigorous comparative effectiveness research (CER) can help to determine     this. This proposal will compare a HIT based intervention to a GV strategy, with and without     the use of social media. These 3 interventions will be compared based not only on clinical     measures of interest but also on parent-defined patient outcomes. Prior research has largely     focused on measuring clinical outcomes such as treatment adherence and ADHD symptom reduction     with little emphasis on understanding how patient-centered outcomes, such as the quality of     life of families dealing with ADHD, are affected.      Building on previous work, the specific aims for this study are:      Aim 1. Compare the preliminary efficacy of three interventions to improve treatment of ADHD     in the primary care setting Aim 1a) Compare the effectiveness of the three interventions on     clinical measures such as parent and teacher rated ADHD symptoms and adaptive functioning Aim     1b) Compare the effectiveness of the three interventions on patient-centered outcomes such as     quality of life and parental satisfaction with the intervention The three interventions will     be: 1) Child Health Improvement through Computer Automation (CHICA) which is the health     information technology innovation arm; 2) Group visits (GV); or 3) Group visits plus online     discussion portal (GV+DP).   "
90222|NCT02105129|"     The primary objective of this study is to assess the safety and tolerability of a single dose     of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg under     fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions of a     standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in Part B,     in healthy male volunteers.      The secondary objective is to determine the pharmacokinetic profile of single (Part A) and     multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the     preliminary effect of food (Part C）   "
90223|NCT02105116|"     This pilot clinical trial studies if cells donated by a close genetic relative can help keep     acute myeloid leukemia (AML) from coming back after standard chemotherapy induces a complete     remission. Blood cells obtained from a donor include a variety of blood cells that may     trigger the patient's immune system to react against AML cells.   "
90224|NCT02105103|"     Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek®     Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational,     multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in     routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on     intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects     will receive training in the preparation, programming and daily use of the Accu-Chek Insight     Insulin pump. In addition, subjects previously on MDI may receive more training in order to     be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in     Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this     study.   "
90237|NCT02104934|"     Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis     of the knee, is a painful procedure and requires a multimodal analgesic approach. A method     for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected     around the knee joint.      Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been     shown to result in minimal thigh weakness.      The investigators aim to study if the analgesia provided by ACB is superior to LIA while     preserving quadriceps strength.   "
90238|NCT02104921|"     This study is utilizing ultrasound measurement to measure neuromuscular disease status in     adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that     ultrasound can be utilized as a tool to determine if a disease is responding to therapy or     progressing.   "
90239|NCT02104908|"     The investigators aim to examine target-controlled propofol infusion as a technique of     anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus     block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which     regional anesthesia was more sufficient for the old.   "
90240|NCT02104895|"     The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole     breast radiotherapy to accelerated partial breast irradiation using intensity-modulated     radiotherapy technique in selected early breast cancer patients after breast conserving     surgery.   "
90241|NCT02104882|"     Glioblastoma multiforme (GBM) is a disease with an extremely poor prognosis. Despite surgery     and radiochemotherapy, the tumors are likely to grow back very quickly.      Intraoperative radiotherapy (IORT) may improve local control rates while sparing healthy     tissue (Giordano et al. 2014). IORT takes place before cranioplasty directly after gross (or     subtotal) tumor resection. Several past studies on IORT for GBM conducted in Japan and Spain     have yielded encouraging results (Sakai et al. 1989; Matsutani et al. 1994; Fujiwara et al.     1995; Ortiz de Urbina et al. 1995).      However, the full potential of the procedure is to date largely unexplored as most previous     studies used forward-scattering (electron-based) irradiation techniques, which frequently led     to inadequately covered target volumes. With the advent of the spherically irradiation     devices such as the Intrabeam® system (Carl Zeiss Meditec AG, Oberkochen, Germany), even     complex cavities can be adequately covered with irradiation during IORT. However, there is no     data on the maximum tolerated dose of IORT with low-energy X-rays as generated by this     system.      The INTRAGO I/II study aims to find out which dose of a single shot of radiation, delivered     intraoperatively direct after surgery, is tolerable for patients with GBM. A secondary goal     of the study is to find out whether the procedure may improve survival rates.   "
90242|NCT02104869|"     This will be an open label, parallel, randomized clinical trial that will evaluate the     immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented)     produced by Instituto Butantan among adult kidney transplant recipients, when administered in     three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two doses     administered with a 21 day interval.      The randomization ratio among the three groups of kidney transplant recipients will be 1:1,     and 60 participants will be included in each group. After vaccination all participants will     be followed for 26 weeks.      In addition, 15 healthy adults will be included as a control group, and will receive the     recommended dose.      The study hypothesis is that a different vaccination regimen can improve the immune response     of kidney transplant recipients after vaccination with the trivalent influenza vaccine     (inactivated and fragmented).   "
90243|NCT02104856|"     The primary objective of this Registry is to collect real-world data on patients undergoing     bronchial thermoplasty (BT) treatment.   "
90244|NCT02104843|"     The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325     combination therapy on the exposure of Rosuvastatin.   "
90245|NCT02104830|"     The purpose of the study is to compare safety and efficacy of a single dose of     empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients     receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).   "
90246|NCT02104817|"     The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design     that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high     risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once     daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.   "
90247|NCT02104804|"     A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety     of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in     Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on     Insulin Alone or on Insulin in Combination with Metformin   "
90248|NCT02104791|"     It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic     subclinical infection.   "
90249|NCT02104778|"     The aim of the present study is to test that adding dexamethasone or epinephrine     significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the     magnitude of the effect differs among dexamethasone and epinehrine.   "
90250|NCT02104765|"     The main purpose of this study is to evaluate the safety of the study drug known as LY2951742     in healthy Japanese and Caucasians. The study will also investigate how the body processes     the drug and how the drug affects the body. The study is expected to last about 5 to 7     months, depending on the arm.   "
90251|NCT02104752|"     The investigators propose to test whether curcumin nanoparticles will improve behavioral     measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who     are already receiving a stable dose of antipsychotic.   "
90255|NCT02104700|"     The study will be an open-label, pilot study in virologically suppressed patients comparing     the efficacy, safety and tolerability of two Antiretroviral regimen strategies:      Arm A: Immediate switch Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation     (STF))at randomization      Arm B: Delayed switch Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase     inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and     followed through 48 weeks.   "
90256|NCT02104687|"     The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on     cardiac index trending by transesophageal Dopplerometry would result in reduced complications     and reduced length of hospital stay in major abdominal surgery patients, when compared to     patients treated with press treatment algorithm.   "
90257|NCT02104674|"     This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess     the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma     treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a     1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC)     injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair     (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.   "
90258|NCT02104661|"     People with multiple sclerosis (MS) have nerve loss even without acute inflammatory relapses,     as obvious in the progressive phase of disease. Drugs that may prevent nerve loss work better     in earlier stages when it is difficult to measure progressive disability. But it is now     possible to measure the nerve loss as neurofilament light (NFL) in the cerebrospinal fluid     (CSF). This is a trial of a neuroprotective drug, oxcarbazepine, which showed benefit in an     animal model of multiple sclerosis. The investigators will use an innovative outcome, a     reduction in the content of NFL in the CSF, as well as the usual clinical disability and     imaging methods, to measure the success of the oxcarbazepine as a neuroprotective agent in     MS. The use of NFL, a surrogate marker of neurodegeneration, allows a blinded and accurate     outcome.   "
90259|NCT02104648|"     This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of     RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in     healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized,     double-blind, placebo-controlled study. Participants will be randomized to receive daily,     oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a     multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control,     parallel group study. Participants will be randomized to receive either multiple or single     doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic     parameters will be assessed for Parts A and B; and continuous ECG recordings will be made     during Part B.   "
90260|NCT02104635|"     This research represents a randomized trial of a program to improve timely postnatal care,     comparing post-natal check-ups performed by community health workers delivered either by     phone or in person to a control group. The study hypothesis is that when community health     workers check on women three days after their delivery we will see improvements in the     detection of maternal and child complications, better knowledge of complications and an     increase in behaviors that are expected to lead to improved maternal and child health.   "
90261|NCT02104622|"     Many people with spinal cord injury are no longer able to walk and must use wheelchairs for     mobility. These individuals experience greater rates of depression and lower quality of life.     Many of these individuals express a strong desire to walk again, and report many psychosocial     benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs     allow only limited community access, creating an additional obstacle to seeking out     meaningful social roles in the community. Currently, there is new technology called robotic     exoskeletons that would allow people with spinal cord injury to walk. These robotic     exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to     community access. Current research has examined training with robotic exoskeletons indoors     over level surfaces in clinical settings. This study will examine the potential for everyday     use, including ramps, stairs, curbs and indoor and outdoor use.   "
90262|NCT02104609|"     The purpose of this study is to determine the effects of obesity on the pharmacokinetics of     the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of     ovulation      Primary hypothesis:      1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger     volume of distribution of LNG.      Secondary hypothesis:        1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women          affect the primary mechanism of action, which is inhibition of ovulation.        2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding          globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free          LNG.   "
90263|NCT02104596|"     Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in     patients with knee osteoarthritis (OA).   "
90264|NCT02104583|"     This study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the     overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions     (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization     therapy-defibrillator (CRT-D).   "
90265|NCT02104570|"     The purpose of this study is to investigate the effects of Kinesio Taping on the position     sense of shoulder after muscle fatigue.   "
90266|NCT02104557|"     Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception     And Management Of Endometriosis-Associated Pain   "
90296|NCT02104154|"     To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test     results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry     analyzer.   "
90267|NCT02104544|"     This is a multi-center, cross-sectional, non-interventional, observational study——an     investigation carried out in 816 pregnant (pregnant week 17±2 group and pregnant week 39±2     group; 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7 group)     from a total of 4 sites in 3 typical areas (1 coastal regions, 2 inland regions and 1 lake     regions) in China to study the correlation between DHA intake and DHA concentrations in blood     and breast milk.   "
90268|NCT02104531|"     The investigators purpose is to determine the ability of a low cost, currently available     imaging technique to predict shoulder movement disorders and the location of shoulder disease     based on motion analysis of subjects with known shoulder disorders.   "
90269|NCT02104518|"     In this study the investigators propose to evaluate the performance of several G6PD testing     platforms.   "
90270|NCT02104505|"     To test the hypothesis that gamma tocopherol (vitamin E) supplement inhibits endotoxin     induced airways inflammation in allergic asthmatics   "
90561|NCT02100709|"     This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation     on COPD patients. In particular the effect on:        -  the amount of daily physical activity        -  Quality of life        -  The 6-minute walk distance        -  Time to exacerbation      and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive     Ventilation as an adjunct therapy.   "
90271|NCT02104492|"     Multiple sclerosis (MS) is the most common inflammatory demyelinating chronic disease of the     central nervous system and the second leading cause of disability in young adults. Motor     deficits also involve respiratory muscles. This involvement is present from early stages of     disease and is frequently dismissed by professionals until advanced stages of disease. The     effect of a training program of respiratory muscles is not sufficiently studied. The aim of     this research is to assess the clinical and functional response of a 12-week respiratory     muscles training program (RMTP) for persons with relapsing-remitting multiple sclerosis     (RRMS).      This study is consisted with two sub research:      Firstly, a single-blind randomized clinical trial will be carried out in 40 persons with     RRMS. Participants either will be received (n = 20) peripheric resistive muscle training     program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP)     with ORYGEN Dual® device for 50 minutes, twice a week during three months or (n = 20) they     will be received peripheric resistive muscle training program and health education program.     Main outcomes will be strength of the respiratory muscles assessed by maximal inspiratory and     expiratory pressure measurements (MIP and MEP). The secondary outcomes will be assessed the     quality of life (MSQOL-54), walking speed (T25-FW, MSWS-12 and Hauser ambulatory index),     fatigue (MFIS), endurance of the respiratory muscles (10RM) manoeuvre and peripherical muscle     strength (Multiple-Sit-to-Stand Test and handgrip strength).      Secondly, the qualitative research where researchers will interview participants about their     interest in carrying out the intervention (difficulties and advantages) and identify themes     of interest about changes in quality of life.   "
90272|NCT02104479|"     Diagnostic accuracy of biomarker testing (galactomannan (GM), (1   "
90273|NCT02104466|"     Peripheral neuropathy is a common complication of diabetes, and one of the strongest     determinants of reduced health-related quality of life among people with diabetes. Neuropathy     frequently presents with painful symptoms, activity limitation, insomnia, fatigue, and     depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at least     moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN), but often     decrease other domains of quality of life through adverse effects, such as dry mouth,     dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical approaches     for PDN are needed, particularly for low income and racial/ethnic minorities who are at     highest risk of diabetes and related complications. Acupuncture is a promising treatment for     PDN, but evidence is limited. To address the significant public health need related to pain     management among underserved people with diabetes, this study proposes an innovative,     group-based model of acupuncture for PDN at an urban safety net hospital. Sixty patients who     have PDN will be enrolled and randomized to one of three arms: (a) usual care combined with     12 weeks of group acupuncture twice weekly, (b) usual care combined with 12 weeks of group     acupuncture once weekly, or (c) usual care alone (20 in each group). The aims of the study     are to determine the feasibility of group acupuncture for PDN among underserved patients with     diabetes; to evaluate the preliminary treatment effects of group acupuncture on pain,     health-related quality of life, depressive symptoms, sleep disturbance, nerve conduction     velocity, and protective sensation; and to determine the optimal frequency of acupuncture     treatments.      The investigators hypothesize that compared to patients receiving usual care alone, patients     who undergo weekly group acupuncture treatments will have:        1. decreased pain intensity        2. improved health-related quality of life        3. improved sural nerve conduction velocity   "
90274|NCT02104453|"     One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and     two-handed mask ventilation with triple airway maneuver are three common airway management     maneuvers. Sniffing position may improve ventilation between these three maneuvers. The     investigators hypothesize that ventilation efficiency may be different between these three     maneuvers whether the patient is in sniffing position or neutral position. The investigators     would like to quantify this effect by measuring the expired tidal volume, airway pressure,     EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.   "
90275|NCT02104440|"     The purpose of this study is to evaluate the safety and efficacy of the sequential infusion     of allogeneic mesenchymal stem cells (MSC), expanded in vitro with platelet lysate without     addition of animal products in the treatment of patients undergoing allo-HSCT who developed     one or more cytopenias.   "
90276|NCT02104427|"     This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF     in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin     lymphoma or Hodgkin disease.   "
90277|NCT02104414|"     The purpose of this study is to compare the quality and duration of pain relief after a     hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine     hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more     effective postoperative pain relief than both bupivacaine hcl and the control.   "
90278|NCT02104401|"     This research will help us to understand whether transcranial direct current stimulation     (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in     people with Parkinson's disease and related disorders. Some of the disorders that will be     studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy     (MSA) and progressive supranuclear palsy (PSP).   "
90279|NCT02104388|"     The purpose of the study is to determine if SJP-0035 ophthalmic solution is effective in     promoting corneal epithelial wound healing in conditions associated with corneal epithelial     disorders.   "
90297|NCT02104141|"     The purpose of this combination retrospective and prospective post market study is to examine     the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE®     plates to treat single and two-level degenerative disc disease between L2 and S1, with a     focus on fusion rates and patient outcomes.   "
92570|NCT02074423|"     The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract     (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard     meal composed of white bread, in healthy male and female volunteers.   "
90311|NCT02103959|"     The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac     injury associated with coronary angiography in patients with acute coronary syndrome (ACS),     but excluding ST-elevation myocardial infarction (STEMI) patients. This study will     specifically examine the ability of CMX-2043 to prevent acute renal injury following coronary     angiography. The study will also examine the ability of CMX 2043 for prevention of     periprocedural cardiac injury. Information will be obtained relating to the ability of CMX     2043 for prevention of major adverse cardiac and renal events following the procedure.     Additional information will be obtained in this study to evaluate safety of the drug. Dose     and regimen information will also be obtained for future clinical studies of CMX-2043.   "
90312|NCT02103946|"     ًًًُُُُThe investigators are testing the efficacy of a new novel technique; serratus anterior     plane block, for preventing postoperative pain after breast surgery for cancer. This block     will be compared with the well-established paravertebral block.   "
90280|NCT02104375|"     Cardiovascular disease (CVD) continues to be the major cause of morbidity and mortality in     western countries. It has been shown that CVD events are known to be higher in the winter     than in the summer. Low environmental temperatures may induce increased cardiovascular stress     resulting in cold-induced hypertension (CIH), the leading risk factor for CVD events. Similar     to whole-body cold exposure, the cold pressor test (CPT), an external local cold stimulus,     has been used for evaluation of cardiovascular and hemodynamic reactivity to sympathetic     stimulation. It has been shown that brachial blood pressure (BP), pressure pulse wave     reflection, aortic BP, heart rate (HR), and arterial stiffness are increased during CPT.     However, the physiologic mechanisms for the cardiovascular complications related to low     temperatures are not completely clear.      Isometric-handgrip (IHG) exercise has been used as a tool for assessing cardiovascular     autonomic control by a maneuver defined as post-exercise muscle ischemia (PEMI). PEMI induces     exercise pressor reflex (metaboreflex) by trapping metabolites in the previous active muscle     at the cessation of exercise. During PEMI, the accumulation of contraction-derived     metabolites induces sympathetic mediated vascular stimulation and an increased BP, whereas     the HR fully recovers. This suggests that the fall in HR is evoked by an increase in     parasympathetic activity which overpowers the sympathetic activation. Implication of IHG     exercise followed by PEMI provides important clinical information because impaired autonomic     and cardiovascular functions are associated with cardiovascular events.      Recently, oral supplementation with the amino acid L-citrulline (L-cit) has been proposed as     a possible adjunct treatment for hypertension and arterial stiffness. L-cit is known to     enhance the bioavailability of L-arginine (L-arg), the endothelial substrate for nitric oxide     (NO) production. Cold exposure might include a temperature-dependent inhibition of     endothelial NO synthase (eNOS), the enzyme that produces NO from the amino acid L-arg and may     trigger various types of CVD. It has been shown that L-cit supplementation has effectively     attenuated the CIH response during cold pressor test. Thus, L-cit supplementation may be     effective to reduce the cardiovascular responses associated with cold exposure and the     exercise pressor reflex imposed by PEMI. Therefore, the proposed study is important for the     following reasons: (1) the results of his study will add to our understanding regarding the     cardiovascular and autonomic mechanisms associated with exercise and cold exposure; (2) the     results of this study will contribute to the development of an adjunct therapy for the     prevention of cardiovascular adverse events that are particularly increased during stress     such as cold exposure and exercise.   "
90281|NCT02104362|"     Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive     treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the     Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk     and intermediate risk tumors. In parallel with these encouraging results regarding     biochemical control, the authors described excellent urinary and digestive tolerance, notably     the absence of grade > 2 complications. However, it should be noted, in this study, that     special protection was provided to the anterior aspect of the rectum by means of a 10 ml     transperineal injection of hyaluronic acid into the prostate-rectal interspace.      The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team     of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90%     local control rate for spinal metastases after a single dose at 18 to 24 Gy.      The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days)     observed following interstitial high dose rate prostate brachytherapy delivering a total dose     of 20 Gy in one fraction.   "
90282|NCT02104349|"     The objective of this study is to evaluate the effect of mindfulness meditation technique on     post-operative pain of spine surgery subjects. Subjects will participate in a 6-week     mindfulness meditation program, beginning two weeks prior to spine surgery. The investigators     are interested in determining if this intervention improves the ability to tolerate pain and     reduces anxiety, thus reducing the need for prescribed analgesics and narcotics. The     meditation intervention will be compared against a control group consisting of subjects that     will undergo music therapy during the same period of time.   "
90283|NCT02104336|"     Treatment of Pediatric Subjects with Pearson syndrome   "
90284|NCT02104323|"     1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant     human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of     the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized     double-blind trial.   "
90285|NCT02104310|"     For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI)     scan. In this study, information from a special scan, called a Positron Emission Tomography/     Computed Tomography (PET/CT) scan using an amino acid called     Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and     guide your radiation oncologist in determining locations to treat with radiation. This type     of scan has shown promise in being able to better distinguish tumor from normal brain tissue     and may help to more accurately plan radiation treatment. This type of scan can also assist     the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of     this study is to use the 18F-DOPA PET/CT scan to help determine where the disease is that     needs to be treated with radiation, in order to improve the effectiveness of radiation in     this tumor.   "
90286|NCT02104297|"     To compare the effect of two different agents deksmedetomidine, remifentanil and placebo,     agitation and recovery condition, on nasal septum operation.   "
90287|NCT02104284|"     Asthmatic patients and non-asthmatic controls were recruited prospectively from four referral     hospitals in Korea. Participants were challenged with each of methacholine and mannitol     inhalation on different days. Their diagnostic utility was evaluated by calculating their     sensitivity and specificity for asthma diagnosis. Response-dose-ratio was also compared.   "
90288|NCT02104271|"     There is a wide variability of options for treatment of chronic radiation proctitis. However,     studies are still limited, usually case reports from a single center and few are comparative     studies between methods. Therefore, the choice of treatment is determined by availability and     local expertise for each method. The variability of treatment options range from     anti-inflammatory medical treatment, sucralfate, short chain fatty acids, antioxidants and     hyperbaric oxygen to such endoscopic and surgical treatments. Surgery is usually the last     therapeutic option due to the high morbidity and mortalityassociated. Various endoscopic     treatment modalities have been reported. Formalin topic is effective in up to 48% of patients     with chronic radiation proctitis.      The endoscopic treatment with argon plasma (APC) is low cost, easy to apply and     transportation, safe and effective in the treatment of rectal bleeding in patients with     chronic radiation proctitis. Currently, the APC is the preferred endoscopic modality.      Most studies on the use of APC in radiation proctitis showed benefit. The APC controls the     mild to moderate rectal bleeding in 80% to 90% of cases and improves symptoms of urgency,     diarrhea and tenesmus in 60% to 75% of cases.   "
90289|NCT02104258|"     The purpose of the study is to compare the effect of two rehabilitation protocols with     different emphasis on eccentric exercises after acute hamstring muscle strain injuries on the     time to return to sports (RTS) and the rate of re-injuries in male athletes.      The hypothesis is that the addition of early eccentric hamstring exercises being performed at     longer muscle-tendon length towards end range of motion alter the outcomes RTS and     re-injuries in a rehabilitation protocol after acute hamstring muscle strain injuries.   "
90298|NCT02104128|"     This study will investigate the role of dopaminergic neural systems in the symptoms and     treatment of depression. 40 patients who meet DSM-IV criteria for a diagnosis of depression     will be compared to a matched sample of healthy controls. The depressed group will receive     open label treatment with Bupropion MR (150mg bd) for 6 weeks. The control group will receive     no treatment. All participants will be assessed before treatment, after 2 weeks treatment and     at 6 weeks treatment. The outcomes assessed will be 1) fMRI estimates of neural response to     reward to emotionally valenced stimuli (1st and 2nd assessments), 2) computer based measures     of emotional processing (all assessments) and 3) standardised questionnaire measures of     depressive symptoms (all assessments). The primary study hypothesis is that altering central     dopamine using Bupropion will lead to altered neural responses to rewarding stimuli in the     depressed patients (i.e. comparing fMRI outcomes between assessment visits 1 and 2). A     secondary hypothesis is that this neural change will predict subsequent symptom response to     the bupropion (i.e. comparing symptom scores between assessment visits 1 and 3), Lastly, the     study will test the hypothesis that baseline differences in reward circuitry will be     particularly associated with symptoms of anhedonia (the inability to experience pleasure).   "
90299|NCT02104115|"     The investigators will apply non invasive Magnetic Resonance Imaging (MRI) techniques     developed in Nottingham to evaluate the gastric emptying, small bowel water content, colonic     gas and volumes in healthy volunteers eating three breads with different amount of gluten     (none, normal, or high gluten) in three consecutive weeks.   "
90300|NCT02104102|"     Check if the Mirror therapy represents an effective method in improving the motor activity of     the hands of institutionalized elderly.   "
90301|NCT02104089|"     The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market     observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of     thoracoabdominal aortic aneurysms in routine care.   "
90302|NCT02104076|"     The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the     US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered     when used in palliation of malignant neoplasms in the biliary tree.   "
90303|NCT02104063|"     The presence of metastatic disease in the lymph nodes within the groin is the most important     factor in predicting the long-term outcome for patients diagnosed with penile cancer.      In the majority of patients diagnosed with penile cancer obvious abnormalities cannot be felt     in the groin even though the cancer may have already spread to the lymph nodes in the groin.     In these patients, a procedure called Dynamic Sentinel Lymph Node Biopsy (DSLB) is required     to determine if the cancer has spread to the lymph nodes in the groin. In DSLB a radioactive     substance is injected at the site of the penile cancer and then travels to the lymph nodes in     the groin which are then biopsied. This procedure requires a general anaesthetic and an     in-patient hospital stay.      In approximately 20% of patients with penile cancer obvious abnormalities can be felt in the     lymph nodes in the groin. However, any abnormality detected may not necessarily be due to     metastatic disease. In order to confirm if metastatic disease is present in the lymph nodes     of these patients a biopsy is also required. However in these patients the lymph nodes are     detected and biopsied using an ultrasound scan rather than by passing a radioactive substance     into the body.      MRI-PET is a new procedure which combines conventional MRI (Magnetic Resonance Imaging) and     PET (Positron Emission Tomography) scans into one scan. MRI - PET scans create very clear     pictures of internal body structures. MRI-PET is a non-invasive procedure which can be     performed on an out-patient basis.      The accuracy of MRI-PET in detecting metastatic penile cancer is not known. The main purpose     of this study is to establish the effectiveness of MRI-PET compared to DSLB and ultrasound     guided biopsy in detecting the presence of metastatic disease in the lymph nodes of patients     with penile cancer. If effective, MRI-PET could replace the invasive procedures currently     required for detection of metastatic penile cancer.   "
90304|NCT02104050|"     The objectives of this trial are to investigate the efficacy and safety of six weeks of     treatment with OLT1177 Gel in subjects with moderate to severe pain associated with     osteoarthritis of the knee following cessation of pain therapy.   "
90305|NCT02104037|"     The purpose of this study is to investigate transfer of liraglutide from blood to     cerebrospinal fluid.   "
90306|NCT02104024|"     This study is to investigate whether it is possible to use a special type of ultrasound scan     (CEUS, Contrast Enhanced Ultrasound Scan) to view the shape, assess blood supply and     calculate the amount of oxygen being carried to a transplanted kidney and pancreas. We     currently use a nuclear scan (Transcan) to assess this in the kidney. This is cumbersome,     involves nuclear medicine and takes 45- 60 minutes to complete.      We do not routinely image the blood supply to the pancreas post-surgery, despite the most     common complication post pancreas transplantation being vascular in origin. In an emergency a     CT angiogram is carried out. This involves transfer of a sick patient to the CT scanner and     injection of contrast which is harmful to the kidneys.      CEUS involves injection of a safe contrast prior to conducting an ultrasound scan. This can     be carried out at the bed-side, provides instant results and is cheap and safe enough to do     on a routine basis for all kidney and pancreas transplant recipients. Although the uses of     CEUS are well recognised, it is currently not routinely used in transplantation. CEUS has     been compared to other modes of imaging and has been found to be comparable/ beneficial.     However, it has never been compared to Transcan. We will therefore perform CEUS on our kidney     transplant recipients and compare the results to Transcan. We will also assess whether CEUS     is able to visualise the blood supply to the kidney and pancreas and quantify the perfusion     to the pancreas.   "
90307|NCT02104011|"     Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization.     Development of anti-angiogenic therapies is a major and growing field of research in     hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged     treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects.     We showed recently that beta-blockers were able to induce regression of infantile hemagiomas.     Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the     presence of beta2 receptors.      The aim of the study is to estimate if beta-blockers could induce regression or stabilization     of renal angiomyolipomas in tuberous sclerosis in a pilot study.   "
90308|NCT02103998|"     The investigators hypothesize that continuous infusion of 4 µg/Kg/day T4 with 30 µg/Kg/day     oral potassium iodide (KI) for 42 days from birth will reduce by 30% or more (from an     estimated 30% to 21%) the proportion of extremely low gestational age subjects with a     composite endpoint of cerebral palsy (CP) or a Bayley III Composite Cognitive Score < 85 at     36 months corrected postnatal age (CA).   "
90309|NCT02103985|"     The purpose of this study is to evaluate the effect of food on the bioavailability of a     single oral dose of JNJ-39823277 and its active metabolites.   "
90310|NCT02103972|"     The primary objective of this trial is to assess the efficacy of the consumption of     heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo     treatment.   "
90313|NCT02103933|"     The purpose of this study is to assess the level of knowledge of surgery for women who     underwent hysterectomy   "
90314|NCT02103920|"     The purpose of this study is to determine the expression of molecules involved in the     glycine/serine pathway using immunohistochemistry in solid tumors. Archived paraffin-embedded     pathological specimens from the Department of Pathology, NUH will be obtained. Tissue     microarray (TMA) is a high-throughput method of analysing large numbers of formalin-fixed,     paraffin-embedded tumor at a minimal cost and effort. To analyse the expression of molecules     of putative relevance to the glycine/serine pathway, (such as PSPH, PSAT1, SHMT1, and GLDC),     TMA technology will be utilised as previously reported (Kristiansen, Zhang, Soong). Tissue     arrays will be constructed from solid tumors including cancers of the colon/ rectum, lung,     breast, cervix, ovary, endometrium, fallopian tube, prostate, kidney, testis, stomach, liver,     brain and lymphoma. One hundred cases of each tumor type (subject to availability) will be     stained using immunohistochemistry. Patient Identifiers will not be collected. Societal     benefit in terms of knowledge gained to improve understanding of cancer. No direct risk to     subjects as this is a retrospective study of archived pathological tumour samples.   "
90315|NCT02103907|"     There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to     healthy older adults. Balance is a key element of function that allows individuals to     maintain posture and respond to perturbations, and poor balance control, a risk factor for     falls, has been noted in those with knee OA. There is a lack of research guiding treatment     for balance deficits in knee OA, with interventions aimed at improving balance deficits in     those with knee OA having mixed results. Targeted dynamic balance interventions in other     patient populations have been shown to significantly improve dynamic balance control and     physical function. If results similar to such populations can be achieved, such a program may     produce a significant reduction in functional disability in the knee OA population and     improve quality of life. The purpose of this study is to examine the effect of a 10-week     targeted dynamic balance intervention on dynamic balance and physical function in people with     knee OA. This will be a randomized controlled trial (RCT).   "
90316|NCT02103894|"     The goal of this study is to assess [18F]MNI-777 PET imaging as a tool to detect tau     pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy,     including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy     (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age-     and gender-matched healthy subjects.   "
90317|NCT02103881|"     This research study is being done to find out if one of two drugs, ketamine or haloperidol,     is better for treating agitation. Agitation is a state of extreme emotional disturbance where     patients can become physically aggressive or violent, endangering themselves and those who     are caring for them. Often chemical substances or severe mental illness is involved in this     level of agitation. Specifically, the investigators are interested in studying agitation that     is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine     is superior to haloperidol for treatment of agitation in the prehospital environment.   "
90318|NCT02103868|"     Zari workers in Mumbai city will be assessed for tobacco consumption habit. They will be     divided into 3 arms as - 1) First arm will get Medium intensity tobacco cessation     intervention 2) Second arm will get low intensity tobacco cessation intervention 3) Control     arm. At the end of 12 months of intervention quit rates will be compared.   "
90319|NCT02103855|"     Kidney damage is a major complication of current antirejection medicines used in     transplantation. An increasing number of brittle diabetics are successfully receiving a     pancreas transplant. One of the challenges following pancreas transplant is that a patient     can develop kidney damage from one of their antirejection medicines, tacrolimus. The     objective of this study is to substitute a new antirejection medicine which does not cause     kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus     related kidney damage to slow the progression of kidney disease.   "
90320|NCT02103842|"     The purpose of this study is to determine how omega-3 fatty acids influence muscle protein     metabolism and mitochondrial physiology in the context of human aging.   "
90321|NCT02103829|"     Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on     their own. The purpose of this study is to determine whether very brief suggestions provided     online are comparatively more effective than others in increasing motivation to quit     immediately after the suggestions are implemented and actual quit rates one month later.      There are no costs associated with participating in this study and participants will not be     compensated for their participation.      To join the study paste the following link into your browser:      https://www.i4health-pau.org/quit-smoking-on-your-own      The entire study takes place online on an automated website.   "
90322|NCT02103816|"     The purpose of this study to evaluate the SmartLipo Triplex laser system along with the     SideLaze800 hand piece in the treatment of Acne Scars.   "
90323|NCT02103803|"     This proposal aims to describe the oculometric features present during King-Devick (K-D)     testing for subjects who experienced sports-related concussion. The investigators aim to     better describe the underlying oculomotor anomalies present in this cohort that lead to     increased K-D test time. Understanding these anomalies will allow for better understanding of     the effects of sports-related concussion and may provide a rapid and reliable metric for     diagnosing concussion as well as monitoring long-term recovery.   "
90324|NCT02103790|"     Neuromuscular diseases are frequently associated with respiratory failure, which requires Non     Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization     of several days. This hospitalization is problematic because of availability of beds,     logistical difficulties for the patient and estrangement from the usual environment.      For this reasons, the NIV installation at home could be an interesting alternative for both     the patient and the medical staff.      The aim of this pilot study is to test the feasibility of NIV installation at home, using     telemedicine as a remote monitoring tool, and to assess its impact on the ventilation     compliance.   "
90325|NCT02103777|"     The optimum caffeine dose for apnea of prematurity has not been well investigated so the     objective of the study is to compare high versus low dose of caffeine citrate to facilitate     successful extubation in mechanically ventilated preterm infants.   "
90326|NCT02103764|"     The objectives of the present study is to determine the effectiveness of cyclic desogestrel     (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory     dysfunctional uterine bleeding (DUB) in the following aspects:        1. Endometrial histopathology changes        2. Menstrual cycle control.   "
90328|NCT02103738|"     This is an observational study to will evaluate and compare two Ranibizumab treatment     regimens (Standard of care) in patients with neovascular (wet) age-related macular     degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The     results will be used to generate further recommendations on the timing of treatment     administration for patients with neovascular (wet) age-related macular degeneration (wAMD).     In this context, the study will use the anatomical imaging (for example, optical coherence     tomography [OCT]) to evaluate wAMD disease activity impacted by the recurrence of disease     instability and for decision making in the treatment decision algorithm.   "
90329|NCT02103725|"     The purpose of this study is to validate a left-right design with respect to detecting a     difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle     in adults with mild to moderate atopic dermatitis   "
90330|NCT02103712|"     Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy     in 250. The opening of the urethra is located on the undersurface of the penis rather than     the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe     cases. Although the most commonly practised corrective operation ( TIP procedure) gives     generally good results, recently published evidence points to a possible long term risk of     stenosis ( narrowing of the reconstructed urethra). This comparative study will combine     clinical assessment with non invasive measurements of urinary flow to assess the functional     outcome of a large series of patients who have undergone hypospadias surgery . The study is     primarily designed to answer this question : does a modification of the standard operation     which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow     and a decreased risk of stenosis? This has not been previously studied . The findings of our     study could make an important contribution to improvements in the surgical treatment of boys     born with hypospadias.   "
90331|NCT02103699|"     The purpose of this study is to evaluate the effectiveness of a simeprevir-containing     hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).   "
90332|NCT02103686|"     The purpose of this study is to:        1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to          immediate release capsule(150mg * 2).        2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained          release tablet.   "
90333|NCT02103673|"     The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral     and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation     is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer     NMDA receptors in the frontal cortex and hippocampus than controls. This study is a     randomized, double-blind, placebo-controlled drug trial. All patients will be allocated     randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2)     placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than     placebo for cognitive function and clinical symptoms in patients with BPSD.   "
90334|NCT02103660|"     The purpose of this study is to determine the acceptability of randomization to contraceptive     options and estimate the effect of progestin contraception on HIV genital shedding and     inflammatory/immune perturbations in women who may or may not be on antiretroviral therapy,     as well as in HIV-uninfected women controls. It is hypothesized that progestin-containing     contraception will lead to inflammatory changes that may affect the local immune activity,     influencing HIV acquisition or transmissibility risk.   "
90335|NCT02103647|"     The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained     release tablet (300mg) to immediate release capsule(150mg * 2) while multiple dosing.   "
90336|NCT02103634|"     This study will look at two new technologies being developed for measuring cancer in bones.     One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal     body substance. The amount that patients will receive has been shown to be very safe. One     study of over 400 patients showed no adverse reactions after receiving the recommended     dosage.      NaF (known as a radiotracer) is taken up into the bones under a normal process and     researchers can measure the amount within patient's bones through an imaging system called a     Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI). This system combines     aspects of both a PET study as part of the regular standard of care and an MRI study. The     belief is that the combination of these two studies will be better than either study     alone.People who have enrolled in this study will receive their clinically requested PET/CT     scan as part of their normal diagnostic care and will follow all the said recommendations for     this study such as not being pregnant, having fasted overnight, etc. Subjects will return     within 7 days for a 10 mCi NaF PET/MRI study. The patients' imaging time will be up to 120     minutes depending on the MRI sequences acquired. Imaging for the PET portion of the study     will take approximately 20-30 minutes with the rest of the time devoted to MRI sequences.   "
90337|NCT02103621|"     This study will address questions of fundamental clinical significance including: (1) whether     OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation,     (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following     discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful     SRI discontinuation can be identified.   "
90338|NCT02103608|"     This is a clinical study to determine the efficacy and safety of the Glide, hair removal     photo-depilation device, for removing facial hairs. During the first stage, the subjects will     perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will     be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.   "
90339|NCT02103595|"     German Multi-centered, randomized, crossover study in diabetic patients evaluating two     infusion sets under real life conditions at home. Subjects will be randomized to use one of     the infusion set devices during the first period of 4 weeks, and be switched to the other     infusion set for the second period of 4 weeks.   "
90340|NCT02103582|"     The Quit & Fit intervention will be designed as a 12-week study to promote smoking cessation,     increase physical activity levels, and reduce weight gain through regular exercise and     healthy nutrition for African American Women smokers.      Patients will be assigned to the fitness intervention group or control groups by a computer.   "
90341|NCT02103569|"     The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose     combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive     agent.   "
90343|NCT02103543|"     Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for     this research study. These patients don't need immediate surgery for this problem. Treatment     of this kind of back pain with spinal stenosis usually includes physical therapy exercises     and steroid injections. Both treatments are usually helpful in patients with back pain with     spinal stenosis. However, physicians and other healthcare providers don't know which     treatment is better to give first. The purpose of this research is to answer that question.     Patients enrolled in this study will receive both treatments: physical therapy (PT) and a     steroid injection (shot). However, patients may get the shot first followed by PT, or they     may have PT first, followed by the shot. Their time in this study will last up to 6 months,     and there will be five outcome measurements (via visits or telephone). All study visits will     take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about     120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization     computer program.   "
90344|NCT02103530|"     The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early     response assessment of induction chemotherapy in acute myeloid leukemia patients.   "
90345|NCT02103517|"     The purpose of this study is to determine whether omega-3 fatty acids supplementation are     effective in the improvement of suboptimal health status and cardiovascular risk.   "
90346|NCT02103504|"     The DePuy Attune knee system incorporates several key features aimed at improving kinematics     of the knee joint, range of motion, and smoothness of use compared to existing total knee     replacement technologies. As this is a newly approved medical device, clinical testing in     patients using high precision diagnostics is important to evaluate the stability of implant     fixation and in vivo function. We propose a multi-centre consecutive series study examining     the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total     knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be     utilized to identify the micromotion of the tibial tray with respect to the surrounding bone.     Health status and functional outcome measures will be recorded to quantify functional status     of subjects before surgery and at follow-up intervals.   "
90347|NCT02103491|"     Background: Ultradistance athletes frequently consume salt supplements during competitions to     compensate the loss of electrolytes by sweating. The aim of this study was to investigate the     effectiveness of oral salt supplementation to improve exercise performance during a     half-ironman triathlon. Methodology: Twenty-six experienced triathletes were matched for age,     anthropometric data and training status and randomly placed into the salt group (113 mmol Na+     and 112 mmol Cl-) or the control group (cellulose). The experimental treatments were provided     in unidentifiable capsules and were ingested before and during the race. Participants     competed in a real half-ironman triathlon and race time was measured by means of chip timing.     Pre and post-race, body mass, maximal force during a whole-body isometric strength test,     maximal height during a countermovement jump, and blood samples were obtained. Sweat samples     were obtained during the running section.   "
90348|NCT02103478|"     This 2-stage, open-label study will evaluate safety and pharmacokinetics of ASTX727, as well     as determine the dose for the study's second stage. In the second stage the selected dose     will be confirmed and evaluated for clinical activity, including response rate.   "
90349|NCT02103465|"     This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine,     as so far no data on elderly population is available.      Primary objective: To assess efficacy and safety of rotigotine in patients with late onset     Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms.      Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset     Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms : sleep     quality; depression; cognitive function.      Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at     least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12     months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom the     caring physician is uncertain on whether or not to start treatment.      Outcome Measurement: Percentage of Responders to treatment in motor (part III) and Activities     of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale     (UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in relation     to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to treatment in mood     in relation to Geriatric Depression Scale (GDS) at visit 4 and 6.      Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset     Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1.      One group will be treated with rotigotine and one group will be treated with placebo, for 12     weeks after titration.   "
90352|NCT02103426|"     The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA]     vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine     whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers,     CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by     the vaccine after repeated ASP0113 IM injection.   "
90353|NCT02103413|"     Although ERCP is almost always successful in patients with malignant biliary obstruction,     selective biliary cannulation fails in some cases and conventional ERCP may not be possible     in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy     (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases,     percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had     various complications and the presence of an external drainage catheter would also have a     cosmetic problem related to the external drainage and an adverse impact on quality of life     (QOL) of terminally ill patients.      Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case     reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and     effective alternative in patients with failed conventional ERCP stenting. The potential     benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for     avoiding long-term external drainage in cases where external PTBD drainage catheters cannot     be internalized, thus significantly improving the QOL of terminally ill patients, and     possibly lower morbidity than PTBD or surgery.      Up to date, only a few case series of EUS-BD with small numbers of patients have been     published, and known the feasibility and safety in terms of the incidence of     procedure-related clinical outcomes.10-21 There has been no comparative study between the     outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications.      The researchers investigated the technical success of EUS-BD and PTBD in patients with     malignant biliary obstruction after failed conventional ERCP as a prospective randomized     comparative study in multicenters. Secondary endpoints were the cost-effectiveness and     complications rates between EUS-BD and PTBD.   "
93888|NCT02057172|"     The purpose of this study is to determine the optimal dose or doses of HM11260C, when     administered once a week under the skin, to improve the control of blood sugar levels in     patients with early-stage type 2 diabetes mellitus (T2DM).   "
90354|NCT02103400|"     Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional     capacity, peripheral muscle strength and quality of life. Despite the high incidence and     severity has not yet been demonstrated whether a physical training program can change these     outcomes. Objectives: To evaluate the effects of an exercise training program in patients     hospitalized for CAP, to compare this effects with traditional physical therapy and assess     whether the inflammatory markers correlate with the functional status of the patient and type     of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients     hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will     be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk     test, Glittre test, measurement of peripheral muscle strength, spirometry, and the     application of quality of life questionnaire Shor Form 36 will be held. The measurement of     inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held.     Patients will be randomized into two groups: one will perform a program of physical training     (stretching, active resistance exercises and aerobic exercises) and the other group held the     traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight     days. On the tenth day the same assessment will be carried out initially described.   "
90355|NCT02103387|"     To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral     training or relaxation training) vs. a time-matched 5-wk health education condition on     psychosocial adaptation and physiological adaptation in women being treated for breast     cancer. Participants assigned to either of the stress management conditions will show     improved psychosocial adaptation and physiological adaptation compared to those assigned to     the health education condition.   "
90356|NCT02103374|"     Design studies of nebulization in COPD does not respond adequately to the clinically relevant     question: the intervention of administering nebulized bronchodilators at home it is likely to     make a profit, compared to the standard optimized treatment as defined by the recommendations     of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical     value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of     profit in this context is based on criteria of dyspnea, quality of life, use of health system     (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).   "
90357|NCT02103361|"     The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic     effect of these medications and to follow live born infants for one year after birth. With     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be     relevant to a medication exposure during pregnancy, and these include both easily     recognizable defects which are visible at birth, as well as more subtle or delayed defects     that may not be readily identifiable without special expertise and observation beyond the     newborn period.   "
90358|NCT02103348|"     This study is designed to characterize subjects in terms of their sputum phenotype. The     purpose of this study is to learn more about the impact of having abnormally elastic sputum     on asthma severity by comparing subjects with severe as well as mild/moderate asthma to     healthy controls. The characterization will include medical history, pulmonary function     testing, imaging of the lungs and biospecimen collection.   "
90359|NCT02103335|"     This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of     relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are:        -  Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory          drug) that has been approved by the United States (US) Food and Drug Administration          (FDA) for the treatment of multiple myeloma.        -  Marizomib is an investigational drug being developed by Triphase that is being studied          for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet          been approved by health authorities, such as the FDA, for general use but have been          approved for use in specific clinical studies. Marizomib inhibits a cellular machine          called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome          inhibitors have been shown to be effective in the treatment of multiple myeloma.        -  Dexamethasone is a corticosteroid drug that affects the immune system (an          immunomodulatory drug) that has been approved by the FDA for the treatment of multiple          myeloma.      This is the first study to evaluate the three-drug combination of pomalidomide (POM),     marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination     with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory     multiple myeloma.      The primary objective of this study is to determine the best drug dosing levels for this     three-drug combination, including the highest safe doses and/or the recommended doses for     future clinical studies of this drug combination. The secondary purposes of this study are to     determine the safety of this drug combination and its effectiveness in treating relapsed or     refractory multiple myeloma. The study will include examination of levels of all three drugs     in the blood during various time points during treatment.   "
90360|NCT02103322|"     To characterize pharmacokinetic profile of test product compared to that of the corresponding     reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia &     Gastrointestinal Stromal Tumor under Fed Conditions.   "
90361|NCT02103309|"     The purpose of this study is to evaluate lens centration and subjective impressions of     DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in     ball sports players.   "
90362|NCT02103296|"     The goal of this protocol is to establish a randomized clinical trial comparing the use of     cord blood vs. infant blood with the primary outcome of comparing both the absolute     hemoglobin concentration and the percent change in hemoglobin concentration from baseline     around 24 hours of life.   "
90364|NCT02103270|"     Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed     after the initial 3 month avoidance period      Secondary Objectives:        -  Identify the basic immune mechanisms which can explain the differences in the effects of          OIT in desensitized vs. tolerant individuals.        -  Determine whether immune monitoring measurements reflecting underlying mechanisms during          OIT can be used to predict responses to OIT in individual subjects and, ultimately, to          improve the safety and efficacy outcomes in peanut OIT protocols.   "
90365|NCT02103257|"     This randomised, controlled, multicentre trial is designed to assess the efficacy and safety     of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in     stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.   "
90366|NCT02103244|"     An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been     developed, that accounts for high BMI, low serum creatinine values and maximal calculated     renal function. The hypothesis is that this new dosing algorithm provides a more accurate and     safe dose than dosing according to the old standard of care.   "
90367|NCT02103231|"     The purpose of this study is to understand more about why young people who were born     prematurely may have increased risk of high blood pressure and lower cardiovascular exercise     capacity.   "
90368|NCT02103218|"     African American adolescent females are more likely to have sex at an early age, to have     older sex partners that have had multiple sexual experiences, and are less likely to use a     condom than their white counterparts. Lack of sexual assertiveness is a factor in the risky     sex behaviors of young African American women. African American girls at the greatest risk     for contracting HIV are the ones that report that their partners could convince them to have     sex and report trouble communicating their wishes related to sex. Thus far no intervention     has addressed the disparate rate of HIV infection in young African American girls. This study     is unique in promoting increases in racial pride as a component of empowerment to help     African American girls self-protect against HIV. The study has the potential to empower young     African American girls to delay sex initiation or reduce risky sex behaviors and thus reduce     their risk of contracting HIV.   "
90369|NCT02103205|"     Breast milk is the gold standard of early infant nutrition and breastfed infants have     advantages in several short and long term outcomes compared to those formula-fed.      The first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant     formula. The general hypothesis is that bovine lactoferrin reduces some of the previously     observed differences between formula-fed and breast-fed infants with regard to health and     development. The main outcome studied is the effect on immune function. The second aim is to     study the effects of lower iron concentration in infant formula and to test the hypothesis     that iron can be lowered without negative effects on health and development. The main outcome     studied here is iron status. Other outcomes in this trial are microbiota composition,     metabolomics, growth, body composition and cognitive development.      To test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron     (2 mg/L) control formula, or the same formula supplemented with bovine lactoferrin. To test     the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher     iron concentration (8 mg/L). Group allocation for all formula-fed infants will be     double-blind randomized. Additionally, breast-fed infants will be recruited and used as a     reference group (gold standard).   "
90370|NCT02103192|"     The objective of this study is to assess the effects of nutrient-fortified beverage on mental     energy in healthy human subjects.   "
90371|NCT02103179|"     The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in     ECC growth, proliferation and apoptosis.   "
90372|NCT02103166|"     The purpose of this study is to determine whether hyoscine bromide decreases the duration of     the active phase of labor.   "
90373|NCT02103153|"     The purpose of this study is to evaluate the PICOSURE Laser System for the treatment of     unwanted tattoos   "
90374|NCT02103140|"     Among African-American women, in whom metabolic syndrome (MetS) is very prevalent and breast     cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the     MetS profile may prove to be a means to reduce breast cancer risk. Specific recommendations     for breast cancer prevention are now focused on maintaining a healthy weight via increased     physical activity levels, and losing weight if overweight or obese.      This pilot project compares two exercise interventions: a supervised facility-based and a     home-based exercise intervention to a control group in African-American women with metabolic     syndrome who are at high risk for breast cancer. This study is a 6-month three-arm RCT to     assess the impact of the exercise interventions on biomarkers related to obesity,     insulin-related pathways, inflammation, hormones, and micro-RNAs.      The specific aim of the proposed study is to compare the impact of a supervised     facility-based and a home-based exercise intervention on obesity, metabolic syndrome and     known breast cancer biomarkers in postmenopausal African-American women with metabolic     syndrome who are at increased risk of breast cancer.   "
90375|NCT02103127|"     The purpose of this study is to assess treatment of facial acne scars using the 755nm     Alexandrite Laser with lens arrays.   "
90376|NCT02103114|"     The purpose of this study is to test whether the administration of ATIII during the     intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB)     and an attenuation of the activation of the coagulation cascade, as represented by a decrease     in fibrin degradation products. The investigators believe this benefit would extend into the     post-operative period resulting in a decreased incidence of thrombosis generation, as     represented by a decrease in fibrin degradation products in the ICU period.   "
90385|NCT02102997|"     The DTS.DE registry is an initiative for the collection of high quality process and     historical data of implantations with the COMBO Dual Therapy Stent in Germany. DTS.DE was     designed as a national, non- randomized, prospective, multicenter registry without a     comparison group.      The responsible Steering Committee is of the opinion that the Combo stent qualifies for     further documentation of treatment results in the form of a German registry, based the CE     certification of the COMBO Dual Therapy stent in 2013 and its clinical and scientific     investigation in the context of the REMEDEE study program, as well as company independent     externally initiated studies with the COMBO Dual Therapy Stent.      It is expected that by mid- 2015, at least 1,000 patients will be enrolled and documented in     the DTS.DE registry with the COMBO Dual Therapy Stent. A clinical follow-up is performed     after 6 weeks and 12 months.   "
90377|NCT02103101|"     Vitamin K antagonists were hampered by several disadvantages, such as the need for frequent     monitoring. In this context, new oral anticoagulants (NOACs) have been developed and are now     available on the market. These NOACs, like all anticoagulant drugs, continue to be associated     with an increased risk of bleeding. In addition, the lack of antidote and the absence of     valid data regarding biological monitoring can pose problems in case of overdose or when     emergency surgery is required. Studies investigating the pharmacokinetic properties of     rivaroxaban and dabigatran, two NOACs now approved for the market, have shown high     variability between individuals, with coefficients of variation of up to 60% for some     pharmacokinetic parameters in patients treated after orthopaedic surgery. The relation     between plasma concentrations of NOAC and bleeding risk has been clearly established in     clinical trials.      Dabigtran, rivaroxaban and apixaban are known substrates of P-glycoprotein (Pgp). Pgp     activity can be affected by pharmacological inducing or inhibiting agents. This can lead to a     significant change in the pharmacokinetics of NOACs, with a decrease or increase     (respectively) in the level of intestinal absorption, leading to respectively reduced or     increased plasma concentrations of the drug. Furthermore, there exist genetic mutations of     Pgp, presenting in particular a lower level of activity than the non-mutated protein. We     hypothesized that the polymorphisms (mutations) of the ABCB1 gene that codes for Pgp could     influence plasma concentrations of dabigatran, rivaroxaban and apixaban, and consequently,     impact on the concentration of NOACs and as a corollary, on the bleeding and thromboembolic     risk of patients treated with these molecules.      The main objective of this study is to study the relation between polymorphisms of the ABCB1     gene that codes for Pgp and plasma concentrations of NOACs in patients treated for a     hemorrhagic or thromboembolic complication occurring under NOAC therapy.      Secondary objectives are to evaluate the distribution of ABCB1 polymorphisms among the     various hemorrhagic risk factors, and to compare the frequency of the polymorphism in     patients from the study population vs the general population.   "
90378|NCT02103088|"     Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of     the prostate gland (prostatectomy) which may be associated with immediate and long lasting     erectile dysfunction and decline in urinary function. Besides these physical late effects     patients operated for PC have a twofold increased risk for depression up to ten years after     the diagnosis. To reduce these late effects affecting both patient and partner the     investigators have developed a sexual and urological intervention (PROCAN). The intervention     is based on epidemiological data, evidence from previous clinical trials, a feasibility study     and qualitative explorations among PC patients and partners. The investigators hereby suggest     the conduction of a randomized controlled trial to test the effect of the PROCAN intervention     on urological and sexual dysfunction, couples adjustment and quality of life. Results of the     proposed trial may provide clinicians and decision makers with the evidence needed to     optimize rehabilitation after PC.   "
90379|NCT02103075|"     Spinocerebellar ataxia (SCA) is a hereditary disorder with movement incoordination. The     ataxia performed low intra-cortical facilitation mainly due to the degenerative cerebellum.     Noninvasive sensory stimulations such as peripheral electrical stimulation were reported to     modulate the excitability of the motor excitability. Neuromuscular electrical stimulation     (NMES) was proposed as a neuromodulation tool for the aberrant motor excitability on the SCA.     This study aims to investigate the effect of NMES on the motor excitability in the SCA, and     the differentiation on the central or peripheral motor excitability changed by the NMES.   "
90380|NCT02103062|"     The purpose of this study is to evaluate the safety and efficacy of Abraxane (nab-paclitaxel)     in subjects with previously treated metastatic colorectal cancer. Subjects will be placed     into two separate cohorts based on their RAS mutation status.   "
90381|NCT02103049|"     In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic     patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is     treated with statins in low doses only as high doses can lead to rhabdomyolysis and are     therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used.     The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney     transplant patients lowers LDL cholesterol for additional 10 per cent.   "
90382|NCT02103036|"     The purpose of the study is determine whether the Core Stability Exercise is more effective     than the traditional Back School for low back pain (LBP) in women.   "
90383|NCT02103023|"     Influenza poses a heavy burden to our health service. The WHO estimates that seasonal     influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including     intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity.     Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment     of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza     virus in mouse model. The objective of this prospective double-blind randomized controlled     trial is to evaluate the effect and safety of topical treatment with imiquimod immediately     before intradermal influenza vaccination in healthy young adults.   "
90384|NCT02103010|"     Radiotherapy is an integral component of the current multimodality treatment approach in     locally advanced head and neck cancer (HNC). There is growing evidence that more aggressive     treatment regimens improve tumour control and survival. However, intensified treatment is at     the expense of increased toxicity, in particular severe acute mucositis. In addition and of     increasing importance, late and irreversible treatment-related side effects, including     xerostomia and swallowing dysfunction, occur in a considerable proportion of patients and     negatively affect quality of life.      High-risk human papilloma virus (HPV), specifically HPV type-16, is implicated as the     causative factor in a proportion of HNC, especially those of the oropharynx. HPV-related     cancers respond well to chemoradiotherapy compared to HNC related to tobacco and alcohol.     Furthermore, the incidence of HPV-related oropharyngeal cancer is rising in Western     countries. Given the significant toxicity associated with concurrent chemoradiotherapy,     subsets of patients could be managed differently.      The first objective of the project is to develop predictive models for radiation-induced     dysphagia and xerostomia in HNC patients. Clinical characteristics, treatment parameters,     dose-volume effects on healthy tissues and whole-genome genetic data will be considered. The     second objective of the project is to study the prognostic value of HPV status together with     a panel of tumour biomarkers in oropharyngeal cancer patients. The overall aim of the project     is to stratify patients according to the risks (side-effects) and benefits (survival) of     cancer treatment using the developed risk models. Clustering patients into different risk     categories may aid treatment decision making reducing therapy toxicity without compromising     survival.   "
90386|NCT02102984|"     Patency duration of covered metal stents as compared with uncovered metal stents in the     management of malignant strictures of the extra-hepatic biliary tree.   "
90387|NCT02102971|"     The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role     in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve     hepatic function of patients with liver diseases.   "
90388|NCT02102958|"     Because people who have both diabetes and visual impairment have high risk for foot problems,     prevention of ulcers and amputation is a high priority. Usual care in diabetes     self-management education (DSME) is to teach them to seek sighted assistance for regular foot     examination, yet clinical experience suggests that this advice is seldom heeded. One possible     solution is to teach use of the nonvisual senses of touch and smell for a systematic,     thorough foot self-examination. The purpose of this pilot study was to compare the efficacy,     acceptability, and feasibility of nonvisual foot examination with usual care (examination of     the visually impaired person's feet by a sighted family member or friend).   "
90389|NCT02102945|"     In the present pilot study, the investigators propose to determine if performing CT perfusion     scans in post-cardiac arrest patients in coma will help prognosticate the outcome in these     patients.   "
90390|NCT02102932|"     The aim of the trial is to assess the relative bioavailability of fixed dose combination     tablets of Empagliflozin and metformin compared to the administration of single tablets     (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose     combination tablet is expected to significantly enhance patient's compliance with     antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic     patients.   "
90392|NCT02102906|"     Functional motor disorders, also called motor conversion disorder, are common reasons for     attendance at neurology outpatient clinics. Patients with functional motor disorders are more     common than patients with multiple sclerosis and have similar levels of disability but more     psychological morbidity.      There is limited evidence for effective treatments in functional motor disorders. A small     number of studies of transcranial magnetic stimulation (TMS), a painless method of cortical     stimulation, have reported improvement in functional weakness after this treatment including     in patients with symptoms of several years duration. The Investigators intend to trial TMS in     a group of 40 patients with functional motor disorder, randomising patients to immediate or     delayed treatment and therefore comparing a single session of TMS with routine clinical care.     The Investigators will also ask patients to undergo tests of attentional focus in a cognitive     neuroscience laboratory - these experiments will be analysed separately from TMS trial data.   "
90393|NCT02102893|"     Neuroendocrine tumors (NETs) are neoplasms originating from neuroendocrine cells located     throughout the body. They secret various peptides and cause various symptoms (carcinoid     syndrome) or not. The incidence of NETs was not well-known till recently when Yao et al. and     Hausa et al. published their surveys of NETs using data from the US Surveillance,     Epidemiology, and End Results (SEER) program and from the Norwegian Registry of Cancer (NRC).     The incidence of NETs in Taiwan by using the Taiwan Cancer Registry (TCR) data was increased     from 0.3 to 1.51 per 100,000 from 1996 to 2008. The increased incidence for NET worldwide     probably was partially due to the awareness and improvement of diagnostic technology.     Compared with the incidence in western countries, the incidence of NET is much lower in     Taiwan. And the incidence of NETs in Asian Pacific Islanders was also lower than the whites     and blacks in US. Gastroenteral-pancreatic NETs (GEP-NETs), accounting for half to two thirds     of all NETs, is the most common site of NETs. As the progress in the understanding of     pathophysiology for GEP-NET, there are two novel targeted agents shown to be effective for     the treatment of GEP-NET. Meanwhile, response to mTOR inhibitor was better for Asian than     Caucasian in the phase III study using everolimus for advanced pancreatic NETs. These     information suggests that there is racial difference for either genetic or environmental risk     factors and these factors result in different incidence and/or clinical outcome. Currently,     there is limited data for thorough epidemiologic study in Taiwan. The aim of this study is to     collect clinical information for GEP-NET, and survey the prognostic factors for GEP-NET in     Taiwan. We suppose that this epidemiologic study would provide a database potentially to     improve the diagnosis, and treatment of GEP-NET. This study plans to include 600 GEP-NET     patients. NET patients diagnosed after 2011.1.1 is included in this study.      Furthermore, we will provide the check of immunohistochemical staining for the tumor tissue     of GEP-NET patients, including the functioning status (insulinoma, glucagonoma, gastrinoma,     VIPoma) and the degree of differentiation, the expression of SSTR2 or SSTR5 and the check of     possible primary site for unknown primary NET patients. This examination will provide more     accurate diagnosis for the patients and further treatment suggestion for the patients.   "
90394|NCT02102880|"     Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic     component. Given that it is known that impaired regulation of choroidal vascular tone is     present in patients with AMD, the current study seeks to investigate whether genetic     polymorphisms in risk alleles for AMD are associated with altered choroidal blood flow     regulation in healthy subjects. For this purpose a total of 220 healthy volunteers will be     included. Choroidal blood flow regulation will be evaluated by measuring choroidal blood flow     during isometric exercise. In addition, flicker induced vasodilatation will be studied and     retinal vessel calibers will assessed, as well as retinal thickness and macular pigment     optical density.   "
90395|NCT02102867|"     The purpose of this study is to: (a) adapt existing vaginal USPE items/instruments for     evaluation of similar elements of rectal compartment use; (b) develop these scales using 3     distinct semi-solid formulations that represent a range of physicochemical and rheological     properties of microbicides that are currently being designed for dual compartment use; and     (c) develop novel USPE instruments to capture the experience of product use in the context of     receptive anal intercourse (RAI) in both male and female cohorts.   "
90396|NCT02102854|"     Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection     following kidney transplantation and is routinely administered as a series of 5-7 consecutive     daily doses via central intravenous catheter.Single large-doses of rATG have been shown to     have equivalent safety and efficacy profile compared to the standard daily protocol when used     as an induction agent but there are no reported experiences of its use for rejection     treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration     including correlation to length of hospital stay and hospital costs.   "
90397|NCT02102841|"     The aim of this study is to investigate the mechanisms behind the immune dysfunction that     occurs in atopic eczema (or atopic dermatitis).   "
90398|NCT02102828|"     The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent     sequential compression with cold therapy and is designed for single patient use in the home.     Additionally, it can track patient compliance. This study will examine if there is a     difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total     knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a     cooling device/MCD system.   "
90399|NCT02102815|"     To determine efficacy of preoperative IV dexamethasone for postoperative pain control after     TKA.   "
90400|NCT02102802|"     This study measures biological and psychological processes that might help researchers to     better understand what is taking place during low or medium dose and full dose MDMA-assisted     psychotherapy treatment in people with PTSD. Heart rate variability (HRV) will be measured up     to three times; before and once or twice after receiving MDMA-assisted psychotherapy. Brain     activity will be measured before and after MDMA-assisted psychotherapy in response to     personalized trauma-related scripts. Participants will complete a measure of self-compassion     at baseline and two months after a final experimental treatment session. Therapy techniques     observed during recorded treatment sessions will be classified using a standardized clinical     measure.   "
90401|NCT02102789|"     The primary objective of this study is to determine whether systemic chemotherapy combined     with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete     resection rate (R0) and improve the overall survival in patients with initially unresectable     colorectal liver metastasis.   "
90402|NCT02102776|"     The purpose of this randomized multi-center clinical trial is to compare the efficacy and     safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and     Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also     evaluate particular risk factors related to pterygium recurrence.   "
90562|NCT02100696|"     This phase III, double blind, placebo-controlled, multicenter study will investigate the     efficacy and safety of etrolizumab during induction and maintenance of remission in     participants with moderately to severely active ulcerative colitis (UC) who are refractory to     or intolerant of TNF inhibitors.   "
90403|NCT02102763|"     The purpose of the GRECO study were to: a) to provide national data on overweight and obesity     prevalence in a representative sample of primary schoolchildren aged 10-12 years old, b) to     identify those socio-economic, demographic factors, as well as dietary and physical activity     habits and familial characteristics that are associated with childhood and preadolescent     overweight and obesity, c) to identify lifestyle and dietary patterns that are associated     with elevated blood pressure levels and dietary sodium intake.   "
90404|NCT02102750|"     The purpose of the study is to examine how preservative free tafluprost ophthalmic solution     (0.0015%) is distributed in blood circulation after ocular administration in children who     have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general     will also be assessed.   "
90405|NCT02102737|"     Insulin resistance is closely associated with apparition of type 2 diabetes mellitus; it is     an independent risk factor and predicts future cardiovascular events.      Hyperinsulinemic euglycemic clamp is a validated method to assessment of insulin resistance     and It is also the gold standard technique. However, the complexity and length of this     technique render it unsuitable for routine clinical use.      In this study, the investigators use a new technique to provide precise, objective, fast and     automated quantification of insulin resistance with camera SPECT.      They compare the results with those of the measurement of hyperinsulinemic euglycemic clamp     in population with or without insulin resistance.      The proposed study is to validate this new non-invasive imaging technique for evaluation of     insulin resistance in patients with or without insulin resistance with a comparison with     hyperinsulinemic euglycemic clamp.   "
90406|NCT02102724|"     HIV infection is associated with premature aging of the immune system. It is believe that the     persistent inflammation that accompanies HIV infection is a major contributor to premature     immune aging. Fish oil has well-documented anti-inflammatory properties. In this randomized,     clinical trial, we're testing whether a 12-week course of fish oil supplementation will     reverse premature aging in HIV-infected older adults.   "
90407|NCT02102711|"     Vitamin A is essential for optimal growth, and development. In the newborn, especially if     preterm, it is necessary for the cellular differentiation, for the health of the anterior     eye, it is a constituent of visual pigment, and it is essential for surfactant synthesis.     Immune response Vitamin A supplementation demonstrated to reduces infancy mortality, but very     low (<1500g birth weight) and extremely low (<1000g birth weight) preterm infants are born     with low body stores of vitamin A and are at high risk of vitamin A deficiency. Nevertheless,     optimal vitamin A supplementation for these infants is not clearly defined, despite evidence     of benefit of an early supplementation.      Prematurity is associate to the risk for bronchopulmonary dysplasia (BPD) which is a disease     marked by respiratory compromise associated with high mortality and severe long-term     morbidity, as well as prematurity is associate to the risk for retinopathy, a pathology that     may be related to less rhodopsin quantity which seem dependent on vitamin A concentration.     Vitamin A can be given enterally, intramuscularly, or intravenously. Recently an oral     administration as drops is available resulting particularly convenient avoiding the pain     associated with repetitive intramuscular injections, or the discomfort of parenteral     administration. Studies of vitamin A in the infant population suggest that plasma retinol     concentrations >0.7 µM/L indicate vitamin A sufficiency, nevertheless preterm infants have     lower concentration and concentration < 0.35 µM/L are very dangerous. Vitamin A deficiency at     this level may constitute a problem for preterm newborn, resulting for example, in     histological alterations in the respiratory epithelium leading to chronic lung disease,     retinopathy of prematurity, patency of the ductus arteriosis, and immune competence     deficiency.      The aim of the present study is to verify efficacy and tolerability of a new oral     administration of vitamin A as drops, 3000 IU/kg/die for 4 weeks, in infants < 1500g weight     at birth, verifying the competence of the supplementation reaching ideal blood concentration     (≥0.7 µM/L) and relating the blood achieved concentrations of vitamin A to the outcome in     typical pathologies, as BPD and ROP. Not treated group of matched newborn infants is the     controlarm.   "
90408|NCT02102698|"     Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has     been hypothesized that abnormal interactions of dopamine with its receptors may cause the     tics. The purpose of this study is to test the hypothesis that a drug (ecopipam) that     selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the     tics.   "
90409|NCT02102685|"     The presence of deep abscess in the neck is potentially severe, it can also lead to death in     short term. The surgical treatment is indicated when there is commitment of the airway,     critical condition, septicemia, complications, descendent infections, diabetes mellitus with     no improving during the first 48 hours of parenteral antibiotic treatment and subsequent     healing of the wounds until it heals by second intention. In this study investigators propose     the use of vacuum Assisted Closure (VAC) that has been used satisfactorily to reduce edema,     promote granulation, and ameliorate the tissue to afterwards reconstruct the defect, increase     vascularity and diminish the bacterial load.   "
90410|NCT02102672|"     Pulmonary artery hypertension (PAH) is a chronic and progressive disease that affects 15     persons per million. Although current therapy has improve disease prognosis, PAH still has a     poor survival, with a median survival of 2.8 years after diagnosis. In the last few years new     key elements in PAH pathogenesis have been discovered, such as the role of metabolism in     disease onset and progression. In fact, PAH pulmonary smooth muscle cells switch into a     glycolytic phenotype which resembles the metabolism of cancer cells. The investigators     hypothesis is that fatty acid oxidation inhibition reverts the PAH adverse phenotype by     restoring mitochondrial function and morphology, decreasing proliferation and restoring     apoptosis susceptibility in pulmonary smooth muscle cells    "
92571|NCT02074410|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     OMS643762 (the study drug) in subjects with Huntington's disease (HD).   "
90436|NCT02102334|"     In total hip arthroplasty (THA), radiographic preoperative planning and postoperative     evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD)     require good validity, interobserver reliability and intraobserver reproducibility.      Questions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by     comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability     and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and     anteversion.      90 patients with primary unilateral osteoarthritis (OA) were included in this prospective     study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method, LLD,     acetabular cup inclination and anteversion were measured. The interobserver reliability and     intraobserver reproducibility were made by three independent observers. The validity and     degree of prediction of Sundsvall method are measured by comparing its results with the     standard method.   "
90563|NCT02100683|"     The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and     effectiveness of the device in the post-approval phase.   "
93889|NCT02057159|"     Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study     of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary     Progressive SPMS   "
90411|NCT02102659|"     1. Clinical nutritional support therapy is an important progress of modern medicine.        2. Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not          just lack of accuracy and immediacy but also difficult to dynamically reflect the          fluctuation trend of nutrition status.        3. It has been reported that malnutrition affects proliferation and apoptosis of human          cells in vivo. This preliminary study was initiated by the hypothesis that changes in          nutritional status may be reflected rapidly in fast proliferating cells.        4. In the previous studies the investigators already found that apoptosis rate of oral          mucosal epithelium could reflect changes in nutritional status.There were an obvious          decreasing in apoptosis and proliferation rate of oral mucosal epithelium in          malnourished patients.        5. Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau          being achieved by increase the nutrition amount continuously, Maintain this amount of          nutrition given until the end of treatment. The investigators call this amount of          nutrition the upper limit nutrition support therapy.        6. The patients applying forupper limit nutrition support therapy and Formula nutrition          support therapy separately, comparing of the two methods influences on postoperative          wound healing, postoperative complication rate ,inflammatory response, side effects of          chemotherapy, hospital stays and hospitalization expenses.   "
90412|NCT02102646|"     The purpose of this study is to investigate if androgen deprivation therapy in men with     prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat     distribution.   "
90413|NCT02102633|"     The study evaluates the effect of a single oral dose of bosutinib on the single dose     pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.   "
90414|NCT02102620|"     Objective - to evaluate the effectiveness and tolerance of intra-articular injections (IAI)     of hexacetonide triamcinolone (HT) for the treatment of osteoarthritis (OA) in     interphalangeal joints.      Design:randomized, controlled, double-blinded study Materials and methods: sixty patients     were randomized into: the TH / lidocaine (LD) group (n=30) who underwent IAI at the most     symptomatic interphalangeal joint with HT (20mg/ml) and LD 2% or the LD group (n=30) who     received IAI with just LD. Patients were assessed at baseline, 1, 4, 8 and 12 weeks by a     blinded observer. The following parameters regarding the affected joint were assessed: pain     at rest (VASr); pain at movement (VASm); pain (VAS) during the 48 hours after the procedure;     swelling (VASs); goniometry; grip and pinch strength; hand function; treatment improvement;     daily requirement of paracetamol and incidence and types of local side effects after the     procedure.   "
90415|NCT02102607|"     The primary aim of this study was to determine the median effective dose (ED50) for motor     block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the     effect of age on ED50 required for motor block.   "
90416|NCT02102594|"     The aim of this pilot study is to investigate the application of proteasome inhibitor     Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with     therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is     that the proteasome inhibition will lead to reduced antibody titers and improved clinical     outcome.   "
90417|NCT02102581|"     To study the short-term effects of tourniquet use in different ways in total knee     arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group A using     the tourniquet throughout the operation, and group B using the tourniquet starting from the     implantation of prosthesis to the completion of the operation. Operation time, total measured     blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin     level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb     circumference, pain score, and knee joint range of motion were also recorded preoperatively     and in postoperative 3,7 and 14 days.Investigators want to observe the difference between the     two groups. Hypothesis was made that patients in group B may feel better after operation for     short time use of tourniquet.   "
90418|NCT02102568|"     Prospective multicenter study, Out Health Products that evaluates to 2 years the impact of     chemo-induced menopause (MCI) on the functional score of quality of life questionnaire     QLQ-C30 in young women age childbearing and living with breast cancer.   "
90419|NCT02102555|"     The purpose of this study is to determine whether a single dose of IV acetaminophen can     improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient     satisfaction, time to readiness of discharge, and the amount of opiates post operatively will     also be measured.   "
90420|NCT02102542|"     This observational study was designed to prove clinical efficacy of the well known     glycopyrrolate which is considered an orphan drug in Thailand. Since the medication has     never been officially used in Thai people and this particular brand Glyco-P which was made     in India has never been officially proven of its efficacy in Thai people. The study was aimed     to prove if this Glyco-P can modestly increase patient's heart rate, decrease secretion and     safely used in combination with neostigmine for reversal of non-depo muscle relaxant drugs.   "
90421|NCT02102529|"     Endometriosis is one of the most frequent benign diseases that can affect women in their     reproductive age. In severe form, the colon or rectum may be involved. It has been shown that     the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators     evaluated the functional results and quality of life after laparoscopic colonic resection for     endometriosis   "
90422|NCT02102516|"     The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative     administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical     procedures.   "
90423|NCT02102503|"     Low medication adherence in patients with coronary heart disease increases mortality.      This study investigates if an intervention of medication review and counselling can improve     patients' medication adherence and treatment results.   "
90424|NCT02102490|"     The main purpose of this study is to evaluate whether the study drug known as abemaciclib is     effective in treating participants with breast cancer who have already tried other drug     treatments.   "
90503|NCT02101463|"     This trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) for     Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting     period by a qualified vascular surgeon. In addition, it aims to examine the alternative     sm-FBSG for patients with restricted access to centers performing clinical trials with     commercially available devices and those patients with aortic emergencies.   "
90425|NCT02102477|"     This prospective, open randomized phase III surgical trial seeks to study whether radical     prostatectomy (with or without the combination of external radiation) improves     prostate-cancer specific survival in comparison with primary radiation treatment and hormonal     treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or     conservatively treated locally advanced prostate cancer is associated with high mortality.     Modern curative treatment for advanced solid malign tumors include surgery and/or radiation     plus attempted chemotherapy if available to achieve both local control and elimination of     potential micro metastases. Whereas there is evidence that surgery can cure localized     prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced     prostate cancer that includes surgical removal of the prostate.      One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the     prostate enables a full pathological assessment of the tumor characteristics and thus a     better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers     needed to treat with chemotherapy and radiation, and thus improve quality of life after     treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25%     after radiation treatment (56)and surgical removal of the prostate may improve survival     beyond what can be achieved by radiation and ADT. On the other hand, patients treated with     surgery, radiation and hormones will experience side effects of all three treatment     modalities and might fare better if radiotherapy plus hormones can provide oncological     control without prior surgery.      A randomized clinical trial comparing two multimodal treatment regimens of which one includes     a radical prostatectomy is therefore warranted.   "
90426|NCT02102464|"     The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment     of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing     for improvement in meibomian gland function and reduction of dry eye symptoms in comparison     to an untreated control.   "
90427|NCT02102451|"     The purpose of this study is to evaluate the feasibility of rapid scale-up of new hepatitis C     (HCV) treatments, known as interferon-free Direct Acting Antiviral (DAA) drugs, and impact on     the proportion of people with HCV within the HIV-HCV coinfected population of Australia.      It is hypothesised that a rapid scale-up of hepatitis C treatment with interferon-free     therapies in individuals with HIV-HCV coinfection will assist in controlling HCV infection in     this population.   "
90428|NCT02102438|"     There is major concern regarding chemotherapy related toxicity in the group of women older     than 65 years old diagnosed with human epidermal growth factor receptor 2 (HER2) positive     breast cancer (BC). Nevertheless, these patients are at a particularly high risk of breast     cancer recurrence and death. Of note, older patients may experience higher risk for     Trastuzumabe related cardiotoxicity, especially when this agent is combined with an     anthracycline.      Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated     with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.      Investigators sought to investigate safety and outcome data on a cohort of elderly patients     treated with weekly paclitaxel combined with carboplatin and trastuzumab.   "
90429|NCT02102425|"     Peritoneal dialysis, known as p- dialysis (PD), is a dialysis form in which the blood is     purified by using the body's peritoneum. PD dependents on good access to peritoneum. For     this, a catheter is implanted in the peritoneum and tunneled 2-3 cm below the skin. The way     out is called exit site and is close to the navel.      Patients are selected at random to use bandage or not use bandage for three months, then     cross-over. The overall objective of the research is that the patient in PD maintains a     complete and healthy skin without signs of infection around the exit site. In the study     effects by omission of bandage over exit site at patients in PD are examined when the     patients are in a stable process with PD. The patient's exit site is assessed according to     skin character and examined for infection.      The hypothesis is that there is no greater rate of infection in patients without bandage than     in patients with bandage over the exit site, and that patients without bandage will have     stronger skin around exit site.   "
90430|NCT02102412|"     A single center study intended to evaluate the Aer-O-Scope Colonoscope System.   "
90431|NCT02102399|"     The purpose of this study is to verify the effects of two speech-pathology interventions:     vocal warm-up and respiratory training in teachers who work in a public school of the city of     Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and     the hypothesis is that both approaches can produce positive voice changes, but the Vocal     Warm-up will produce the most significant changes.   "
90432|NCT02102386|"     The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in     cerebral blood flow and oximetry during CEA surgery.      Procedures include:      Screening:      ECG, blood draw, neurological assessment, NIHSS      study: CerOX and TCD clock during CEA procedure, data collection from the medical     record/monitors, neurological assessment, NIHSS      30 day follow-up   "
90433|NCT02102373|"     Colonoscopy is a routinely performed procedure in children and adolescents. Proper     visualization of the intestinal mucosa is highly dependent on the quality of the bowel     preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing     of bowel preparation is the key factor and recommends that the delay between the last dose of     bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to     colonoscopy has not been studied in children population, yet. The diet regimen before     colonoscopy is likely less important than the timing of bowel preparation, however may     influence the well-being of children.   "
90434|NCT02102360|"     This clinical study compared a conventional surgical technique (CST) and a minimally invasive     surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.   "
90435|NCT02102347|"     The aim of the proposed study is to analyze the effect of the incorporation of phototherapy     into a therapeutic exercise program on pain, functional capacity, range of motion, muscle     strength in individuals with osteoarthritis of the knees. The participants will be allocated     to different groups through a randomization process using opaque envelopes containing cards     stipulating one of the three following groups: Group A (exercise protocol); Group B (exercise     protocol + phototherapy protocol); and Group C (exercise protocol + placebo phototherapy     protocol). Phototherapy will be performed on the knees diagnosed with osteoarthritis.   "
90437|NCT02102321|"     Treatment of hookworm infected groups with albendazole has been shown to result in an     increase in hemoglobin levels and a related decrease in the prevalence of anemia. Increases     in hemoglobin levels due to treatment have been associated with significant gains in adult     labor productivity.      In this study, the investigators hypothesize that regular treatment of women smallholder     farmers in a high prevalence area with the anti-hookworm drug albendazole and iron     supplementation will improve hookworm associated anemia. Further, regular treatment of     albendazole and iron supplementation will improve their work capacity when compared to a     control group   "
90438|NCT02102308|"     A 12-week multicomponent exercise is effective in improving executive function and gait     performance in dual-task conditions.   "
90439|NCT02102295|"     The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic     acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival     redness.   "
90440|NCT02102282|"     Patients are managed clinically according to ad hoc standards and scientific knowledge by a     multidisciplinary team. Clinical decisions are made after a patient physician discussion.     Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment,     systemic treatment, perinatal results and follow up data are collected.   "
90441|NCT02102269|"     Shoulder pain is frequently reported as a complication among stroke patients. Muscular     imbalance disrupts stability of the glenohumeral joint creating a subluxation. Stretching the     soft tissue can cause shoulder pain which impedes quality of life, length of stay and     rehabilitation outcome. To align the humeral head in the cavitas glenoïdalis a shoulder     orthosis is often provided to the patient. Since the use of these orthoses is not always     considered positive by the patient nor the therapist the question rises if the investigators     can objectify if the subacromial space is reduced when wearing a sling.      Sonography is a valid way to asses subluxation of the shoulder joint by measuring the     subacromial space. To objectify if an orthosis can reduce the enlarged subacromial space the     investigators will use sonography to measure the distance between acromion and greater     tuberosity are between acromion and the humeral head. This distance will be measured with and     without the orthosis and also after a period of at least 4 hours of wearing the orthosis.     This last measurement might inform us about how long the orthosis can correct the     glenohumeral position. To validate the sonographic measurement X-rays will be taken by a     sample of the investigators study population to compare with the ultrasound data.      Two different orthoses will be compared. First of all the actimove sling, which is standardly     used in the rehabilitation centre where patients will be recruited. This sling can be adapted     by the patient itself and is very easy to wear. The disadvantage is that the elbow is     continuously flexed, which enlarges the risk on contractures of m. biceps and m.     brachioradialis. Also the negative influence on the interpretation of the body scheme and on     the quantitative use of the arm can be reasons not to wear this kind of orthosis. The     shoulderlift on the other hand is a newly developed orthosis which supports the shoulder     joint with the arm extended. This is a more normal position during the daily living and     stimulates the use of the paretic arm. An extra adaptation can be adjusted to make it     possible to position the arm flexed in order to reduce oedema of the hand if necessary. The     control group does not wear any orthosis at all.      Additional the investigators will evaluate passive range of motion of the shoulder,     spasticity of the upper limb (modified ashworth scale), active motion of the upper limb (fugl     meyer assessment) and trunk stability (Trunk Impairment Scale) at starting point and after a     period of 6 weeks wearing the orthosis minimal 6 hours a day.      If possible the investigators will do an evaluation of balance on a moving platform and an     evaluation of gait with and without the orthosis after 6 weeks to assess the impact of on     balance and gait.   "
90442|NCT02102256|"     Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear     anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An     auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the     brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not     demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1     year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study     to determine the safety of the ABI.   "
90443|NCT02102243|"     Patients with high aldosterone hormone have higher blood glucose than normal people. This     study is being done to understand how aldosterone hormone affects the nerve activity that     controls blood flow in the muscles and blood glucose. The information may be helpful in     selecting blood pressure medications which can improve not only blood pressure but also     improve blood sugar.   "
90444|NCT02102230|"     The purpose of this study is to investigate the efficacy of a group-based behavioral sleep     intervention, and the incremental benefit provided by an adjunct sleep mobile app, on     cannabis and sleep outcomes among cannabis dependent Veterans.   "
90445|NCT02102217|"     20% of patients who undergo major abdominal surgery will have a major complication, which     requires invasive treatment and is associated with increased mortality, morbidity, hospital     stay and intensive care stay. A quality control algorithm after Major Abdominal Surgery (MAS)     aimed at early identification of patients at risk of developing major complications can     decrease associated morbidity and mortality. Literature studies show promising results for     C-reactive protein as an early marker for postoperative complications, however clinical     significance has yet to be determined. Here the investigators propose a randomized clinical     trial in order to determine the effect of postoperative monitoring with standardized CRP     measurements on postoperative morbidity and mortality, if CRP levels exceed 140 mg/L     additional CT-scan imaging will be conducted.   "
90446|NCT02102204|"     This is a multicenter, single-arm, extension study to characterize the long-term safety and     tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis.   "
90447|NCT02102191|"     Because e-cigarettes do not contain or burn tobacco, they do not appear to deliver the known     toxins found in conventional cigarette smoke.However e-Cigarettes with low dose of tobacco     were found to have immediate adverse physiologic effects after short-term use that are     similar to some of the effects seen with tobacco smoking.      In this study we wanted to assess the short-time effect of one e-cigarette with no tobacco vs     a traditional cigarette.      10 n-smoking subject and 10 actual smokers will be enrolled in the randomized trial.   "
90448|NCT02102178|"     Pain is one of the most incapacitating symptoms because it is a complex experience that     includes sensory and emotional perceptions, in which sensory, affective, cognitive,     behavioral, cultural and social characteristics interact. Around 79% of advanced cancer cases     present pain.      There is evidence that non-pharmacological therapeutic activities are useful for controlling     oncological pain and other symptoms resulting from such diseases.      This study evaluated the results relating to pain modulation and improvement of emotional     symptoms and quality of life, from an occupational therapy program applied to oncological     patients who were receiving palliative care.   "
90564|NCT02100670|"     This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of     MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in     participants with an ankle sprain to support topical MFC51123 gel registration.   "
90449|NCT02102165|"     This program initially aims to recruit 1300 breast cancer patients from a large number of     hospitals across Europe. Eligible patients are those who are 18 or older, either female or     male, and who have not received more than 1 type of treatment from the time metastases were     discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease     relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be     collected for central analyses, together with blood, serum and plasma samples. Any samples     not analyzed immediately will be stored in an independent bio-repository to enable future     (not yet defined) research aimed at better understanding metastatic breast cancer.      In summary, the main objectives of AURORA are to better understand the genetic aberrations in     metastatic breast cancer and to discover the mechanisms of response or resistance to therapy,     in order to ultimately identify the right therapy for each individual patient. At the same     time, patients with genetic aberrations that are being targeted by new drugs in development     will be offered the possibility to participate in clinical trials, when approved and     available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all     patients diagnosed with metastatic breast cancer.   "
90450|NCT02102152|"     The use of inhaled medications for the treatment of pulmonary diseases allows for the     delivery of a high concentration of a drug at the site of disease with reduced systemic     absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully     used in the maintenance treatment of CF patients with chronic colonization with PA     (Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung     functions, decrease the density of the PA in the sputum, decrease hospitalizations, and     reduce the risk of mortality.      Non CF Bronchiectasis share many features in common with CF, including frequent colonization     with PA that leads to deterioration in lung function and increased morbidity. A recent     Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics     in the treatment of bronchiectasis, however further randomized controlled trials with     adequate power and standardized end points are required.      There have been reports in the literature describing the efficacy of inhaled tobramycin the     treatment of patients with non CF bronchiectasis with eradication of PA, and significant     improvement in respiratory symptoms. There were however patients who discontinued treatment     due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest     2005).      TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and     faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry     powder formulation has not yet been trialed in patients with non CF bronchiectasis.      The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in     patients with non CF bronchiectasis, and to gather more data on the benefit of continuous     antibiotic therapy in patients with non CF bronchectais.   "
90451|NCT02102139|"     Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients     undergoing robotic thyroidectomy leads to significant haemodynamic responses such as     increases in blood pressure and heart rate. The investigators evaluated whether a single     preoperative dexmedetomidine injection attenuated the haemodynamic responses to     hydrodissection by reducing the half-maximal effective concentration (EC50) of remifentanil     needed to maintain haemodynamic stability during hydrodissection.   "
90452|NCT02102126|"     The ENSURE study is a multi-center, prospective, single-blind, randomized, controlled study     of the effect of renal denervation on arterial stiffness and haemodynamics in subjects with     uncontrolled hypertension. Bilateral renal denervation will be performed using the catheter,     delivering radiofrequency energy through the luminal surface of the renal artery.   "
90453|NCT02102113|"     The overall purpose of this study is to determine whether a family history of psychosis is     associated with an altered cannabinoid system. This will be tested by studying individuals     with and without a family history of psychosis and comparing their responses to delta     9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that     compared to controls with no family history of psychoses, individuals with a family history     of psychoses will have an altered response to THC.   "
90454|NCT02102100|"     This study will help determine if menthol administered by inhalation via electronic     cigarettes (e-cigarette) changes the reinforcing effects of pure nicotine administered     intravenously in cigarette smokers who smoke mentholated or non-mentholated cigarettes.   "
90455|NCT02102087|"     This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD)     in reducing the contamination rate in blood culture analysis. Blood culture data will be     derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g.     ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may     be included in this study. The ISDD will be compared to current laboratory practices for the     collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as     collection of venipuncture blood for culture without an initial diversion method to divert     and sequester potential blood contaminants.   "
90456|NCT02102074|"     The investigators hypothesize that the presence of tumor cells and tumor markers in     peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early     markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve     our understanding of tumor spread and disease recurrence.   "
90581|NCT02100449|"     In infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction (HPV)     results in a higher regional acceleration time (RAcT) compared to the RAcT measured in     atelectatic consolidations.   "
90822|NCT02097316|"     The study will be conducted, in cross-over with a time interval of at least 2 days between 2     treatment periods. Patients will be randomized into 2 groups According to the order of the     randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of     treatment with their usual pumps.   "
90457|NCT02102061|"     The present study aims to explore the effects of a novel multidisciplinary     non-pharmacological intervention designed to improve health parameters and well-being in     overweight and obese women. The proposed program is health- and quality of life-oriented,     without a focus on weight loss, following the philosophical principles from Health at Every     Size, and may provide an alternative mode of intervention to the traditional one, which is     focused on the concept of weight loss at any cost. To evaluate the efficacy of the     intervention, a mixed-method design combining both qualitative and quantitative assessments     will be applied.   "
90458|NCT02102048|"     The association between HIV infection , insulin resistance and diabetes mellitus is the topic     of many studies that have attempted to analyze the problem from different points of view. In     fact, the risk of insulin resistance in HIV-positive patients on antiretroviral therapy seems     to depend not only on the same factors that determine its incidence in the general population     , but also on the effects of antiretroviral therapy on glucose metabolism. To confirm this     observation, studies that have evaluated the incidence of diabetes in patients with HIV     infection on antiretroviral therapy have shown that the incidence of diabetes in infected     individuals is significantly higher than that observed in the uninfected population. Moreover     others preliminar stadies observed that protease inhibitors may induce hyperglycemia and     diabetes mellitus. Anyway at this moment no large data are available that indicate the     utility to modify the antiretroviral therapy in HIV positive patients with a damage of     glucose metabolism.      ATAGLU is a cohort composed by HIV positive patients in effective and stable combined     antiretroviral therapy (cART) with undetectable viral load. All patients studied had carried     out a therapy with Lopinavir/Ritonavir (LPV/r) + optimal backbone therapy (OBT) and then in     part switch to Atazanavir (ATV) + OBT or Atazanavir/ritonavir (ATV/r) + OBT , in part     continue with LPV/r + OBT .      The objective was to characterize the changes of carbohydrate profile of a cohort of patients     who made a switch from a regimen with LPV/r to boosted or unboosted ATV.   "
90459|NCT02102035|"     Reconstruction of soft tissue defects in the fingers continues to be a challenge problem. The     study reports reconstruction of small to moderate defects of the fingers with the direct and     reversed dorsal digital island flaps and evaluates the results of the use of the flaps.The     main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of     the flap and joint motion.   "
90460|NCT02102022|"     Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid     (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.   "
90461|NCT02102009|"     The purpose of this study is to determine whether nutritional support with a complete formula     is effective to improve malnutrition and respiratory function in patients with chronic     pulmonary disease compared to the standard hospital dietary advise.   "
90462|NCT02101996|"     The average American diet consumed by a significant proportion of the adult population,     supplies excessive calories and large amounts of saturated fat. Saturated fats can be cleared     and used in skeletal muscle, but in obese individuals, biomarkers of saturated fat are found     in the blood, along with markers of poor muscle metabolism.      Both fats and amino acids are processed by the same metabolic pathways in muscle, and the     investigators hypothesize that meals with greater amounts of saturated fat slow muscle     metabolism. A better understanding of the interaction of these to metabolites will allow for     the development of future medications to treat muscle loss in sick individuals and the     elderly.   "
90463|NCT02101983|"     High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients     with acute myeloid leukemia. However, most patients receiving this therapy are required to be     admitted to the hospital during their treatment course.      The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment     given in an in-patient setting versus an out-patient setting.   "
90464|NCT02101970|"     The purpose of this study is to determine if high dose supplementation with the omega-3 fatty     acids EPA and DHA, when added to a weight loss program, is well tolerated in the study     population and if there is an increase in the favorable change in blood and tissue breast     cancer risk factors when compared to weight loss alone.   "
90465|NCT02101957|"     The purpose of this study is to evaluate the effect of cysteamine in patients with     symptomatic Huntington's disease by comparing two groups of patients (cysteamine vs placebo)     on the results of the Unified Huntington's Disease Rating Scale (UHDRS, Huntington study     group 1996).   "
90466|NCT02101944|"     This pilot phase I clinical trial studies the side effects and best dose of wild-type     reovirus when combined with carfilzomib and dexamethasone in treating patients with multiple     myeloma that has come back following treatment or does not respond to treatment. Drugs used     in chemotherapy, such as dexamethasone and carfilzomib, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. A virus called wild-type reovirus may be able to kill cancer     cells without damaging normal cells and seems to work best when given with chemotherapy.     Giving wild-type reovirus with chemotherapy may be a more effective treatment than     chemotherapy alone.   "
90486|NCT02101684|"     Granulosa Cell ovarian carcinoma is an infrequent subtype of neoplasia well differentiated     from epithelial tumors. They account for 5% of all ovarian malignancies and, with an     incidence of 0.4-1.2 cases per 100000 habitants, is considered as a rare disease.      Though most cases are identified at initial stages and can be cured through surgical     resection, distant recurrences have been documented even 10 years after resecting the primary     tumor. At advanced stage it is a lethal disease.      Unfortunately because of the low incidence of this disease randomized clinical trials are     lacking. In fact current evidence for treatment is provided by case reports, retrospective     studies and phase II clinical trials performed one decade ago.      Orteronel, a novel, orally active, selective inhibitor of 17,20-lyase, is being developed as     an endocrine therapy for relevant hormone-sensitive cancers such as prostate cancer and     breast cancer. Orteronel is expected to suppress sex hormone levels in both circulation and     relevant hormone-dependent malignant tissue. Since sex hormone overproduction has been     demonstrated in granulosa cell ovarian tumors and seems to play a major role in this disease,     this study will assess the efficacy or orteronel treating such tumors.   "
90487|NCT02101671|"     The purpose of this study is to determinate if the patients submitted to laparoscopic surgery     in trendelemburg position develope more inadequate anaesthesic emergence than patients     submitted to laparoscopic surgery in other positions.   "
90490|NCT02101632|"     Topical application of BV ointment in patients with Research Diagnostic     Criteria/Temporomandibular Disorder 1a and 1b (RDC/TMD) in experimental group, compared to     placebo (vaseline) in control group.Application was repeated 3 times a day, during 14 days.     Surface electromyography (EMG) was used to measure masseter rest tonus and maximal voluntary     contraction tonus. Pain intensity was also analysed in VAS scale. Effectiveness of BV was     compared with placebo in masseter myofascial pain in patients with TMD   "
90467|NCT02101931|"     Research Problem:      Bladder cancer is one of the major health concerns of the world. The present methods of     diagnosis are: Ultra sound, Cystoscopy, CT scan and urine cytology. All these are stressful     to the patients, particularly Cystoscopy which is commonly employed for the follow up of     Bladder cancer patients.      Research Significance:      The present study will employ a new photodynamic diagnostic procedure to quantify a certain     cancer specific biomarker called Porphyrin, which selectively binds on to the bladder cancer     tissues. In this context the present technique offer viable, very easy and reliable table top     instrumentation for diagnosis and continual monitoring of disease regression through urine.      Research Objectives:        -  To quantify bladder cancer specific biomarkers such as Porphyrin using photodynamic          diagnostic procedure        -  To find out whether this technique might be a new and easy tool for bladder cancer          diagnosis only by urine.      Research Methodology:      The bladder cancer patients is required to swallow a chemical called ALA (5 Amino levulinic     Acid hydrochloride), about 10mg/kg body weight which will play a role of biological     indicator. ALA gets metabolized into certain types of porphyrins which selectively bind on to     the tumor tissues (for a longer time than the normal tissues). 5ml of blood and one urine     samples will be taken before using ALA. The patient must drink water then the urine will be     collected after 4, 8 and 12 hours of taking ALA and the samples will be analyzed by     photodynamic diagnostic procedure.   "
90469|NCT02101905|"     This pilot clinical trial studies how well lapatinib ditosylate before surgery works in     treating patients with high-grade glioma that has come back after a period of time during     which the tumor could not be detected. Lapatinib ditosylate may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
90470|NCT02101892|"     A major reason for the substantial underuse of pharmacological prevention of migraine is its     inadequate efficacy, since only ~50% of patients respond to a specific agent. There is     currently no evidence-based way to identify the patients that will respond to a specific     preventive treatment. Amitriptyline is one of the commonest agents used for migraine     prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of     analgesics according to pain inhibitory capacity has been shown effective by our group for     painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition     capacity gained more from a drug that augment pain inhibition as compared to those with     efficient inhibitory capacity. The investigators now propose to assess migraineurs for their     pain inhibition capacity, and examine whether, along similar reasoning, those with reduced     inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and     neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs,     who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized     two arms parallel double blind design, and followed up for attacks reduction. The     investigators expect to identify the best predictors for efficacy of migraine prevention by     the study drug. This approach will promote individualization of migraine therapy.   "
90471|NCT02101879|"     Approximately 15-25% of all breast cancers are human epidermal growth factor receptor 2     (HER2) positive and it has been well known that HER2 overexpression is associated with more     aggressive phenotype and poor prognosis with resistance to certain chemotherapeutic agents.      Trastuzumab administration as an adjuvant and in metastatic HER2 positive breast cancer is     associated with both symptomatic and asymptomatic cardiotoxicity. The incidence of     trastuzumab-mediated cardiotoxicity were 27% with antracycline combination and 13% when it     was administered with paclitaxel .      Pertuzumab, a recombinant humanized monoclonal antibody binding to the HER2 dimerization     domain, prevents dimerization of HER2 with other HER receptors (HER3,HER1, and HER4)     especially with HER3. Blocking HER2-HER3 dimerization is postulated to be the most clinically     relevant action of pertuzumab and this can effectively block her2-mediated cell signaling.      Pertuzumab is indicated in combination with trastuzumab and docetaxel for the treatment of     patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2     therapy or chemotherapy for metastatic disease.      Treatment of breast cancer with pertuzumab plus trastuzumab plus docetaxel as first line     treatment until disease progression might be complicated by cardiotoxicity in up to 14.5% of     the Patients.      Cardinale et al showed that troponin I (TNI) positive identifies trastuzumab-treated patients     who are at risk for cardiotoxicity and are unlikely to recover from cardiac dysfunction     despite HF therapy.      There is very little data about the reversibility and identification of patients at risk for     cardiotoxicity of the pertuzumab plus trastuzumab plus docetaxel regimen and of those who     will not recover from cardiac dysfunction,this information is crucial. The usefulness of     troponin I (TNI) and Brain natriuretic peptide (BNP) in the identification of patients at     risk for PT cardiotoxicity and in the prediction of LVEF recovery has never been     investigated.      based on this background , this study aim is to evaluate the cardiotoxicity of pertuzumab     plus trastuzumab plus docetaxel regimen and the application of troponin I (TNI) and Brain     natriuretic peptide (BNP) in this setting.   "
90472|NCT02101866|"     This Phase 1 study aims to determine the oral bioavailability of a single dose of a new     vapendavir tablet formulation and compare it to that of the previous vapendavir capsule     formulation. The safety of both drug products will also be assessed.   "
90474|NCT02101840|"     The objective of this study is to examine the abuse liability of a single 40mg dose of 2     controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent     recreational opioid users by assessing the self-reported acute effects of the drugs and     taking blood samples to measure drug concentrations. The investigators think there may be     differences in how well these drugs are liked when swallowed whole due to differences in how     the products are formulated.   "
90475|NCT02101827|"     To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic     procedures.   "
90488|NCT02101658|"     The purpose of this project is to examine potential bias or expectancies in individuals'     measurement and recording of weight in a clinical-research setting.   "
90640|NCT02099682|"     The purpose of this study is to investigate the safety and efficacy of long-term     administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting     in patients receiving low-dose aspirin   "
90505|NCT02101437|"     For acute coronary syndrome patients undergoing cardiac catheterization after stenting, we     will give dual antiplatelet drugs (dual antiplatelet agents) therapy, the choice of the basis     of medical criteria (clinical guidelines) routine as aspirin + clopidogrel or aspirin +     ticagrelor, according to medical guidelines currently no other disposal alternative proposal     (unless adverse drug tolerance or bleeding can not be administered); idea of this experiment     for acute coronary syndrome or conventional cardiac catheterization after stenting, platelet     miRNA expression (miR-96 , miR-200b, miR-495, miR-107) after cardiac catheterization and     interventional treatment of clopidogrel or ticagrelor acceptance of platelet reactivity (PRU)     correlation values (given clopidogrel or ticagrelor determined by the clinician, the patient     follow-up experiment to track only and observation), aims to explore under different platelet     reactivity (hyper-reactive or hypo-reactive), their differences in miRNA performance.   "
90476|NCT02101814|"     The prevalence of obesity is steadily growing in many parts of the world in order to reach     epidemic proportions. Changes in signaling pathways state of hunger and satiety contribute to     the increase in obesity and metabolic syndrome. Currently, the white adipose tissue, also is     considered a secretory tissue by producing numerous adipokines involved in a chronic state of     inflammation, which may interfere with the neuroendocrine regulation of energy balance that     affect the weight loss process. The bariatric surgery is recommended as the most effective     tool in the treatment and control of morbid obesity. The study population will consist of     patients undergoing bariatric surgery of type Roux-en-Y gastric bypass. The study was     performed in Clinical Hospital of the Federal University of Paraná (UFPR). This is a     prospective cohort study with follow up of 6 and 24 months. The aim of this study is to     assess the effects of weight loss after bariatric surgery associated anthropometric     characteristic, metabolic changes (glucose, cholesterol profile,hepatic enzymes, Fibroblast     growth factor- 21(FGF-21), blood pressure), the profile of adipokines pro/anti-inflammatory     (adiponectin, interleukin-6 (IL-6),interleukin-10 (IL-10), C reactive protein (CRP),     plasminogen activator inhibitor-1 (PAI-1), tumor necrosis factor alpha (TNF-α), intercellular     adhesion molecule-1 (ICAM-1), resistin, frizzled-related protein 5 (SFrp5) and neuroendocrine     regulation of energy balance (leptin, neuropeptide Y (NPY) , alpha-melanocyte stimulating     hormone (α-MSH), melanin-concentrating hormone (MCH) and agouti-related peptide (AgRP), as     well as the quality of life in obese adults.   "
90477|NCT02101801|"     Over 60% of crops in Israel are grown in recycled treated waste water. This study aims to     determine whether minute quantities of drugs such as Carbamazepine can be found in     individuals who ingest vegetables grown in waste water.   "
90479|NCT02101775|"     This randomized phase II clinical trial studies how well gemcitabine hydrochloride and WEE1     inhibitor MK-1775 work compared to gemcitabine hydrochloride alone in treating patients with     ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of     time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their     deoxyribonucleic acid (DNA, molecules that contain instructions for the proper development     and functioning of cells), which in turn stops the tumor from growing. The protein WEE1 may     help to repair the damaged tumor cells, so the tumor continues to grow. WEE1 inhibitor     MK-1775 may block the WEE1 protein activity and may increase the effectiveness of gemcitabine     hydrochloride by preventing the WEE1 protein from repairing damaged tumor cells without     causing harm to normal cells. It is not yet known whether gemcitabine hydrochloride with or     without WEE1 inhibitor MK-1775 may be an effective treatment for recurrent ovarian, primary     peritoneal, or fallopian tube cancer.   "
90480|NCT02101762|"     The Foley catheter is one component in a catheter insertion procedure that could contribute     to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter     insertion procedures using the ERASE CAUTI Tray system may help to lower these infection     rates.   "
90481|NCT02101749|"     This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years     will be enrolled and randomized to one of 2 study arms:        1. Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/          0.1 ml dose) (group A - 110 participants)        2. Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose)          (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total          follow up period is 60 days.   "
90482|NCT02101736|"     This study, A Phase II Study of Cabozantinib (XL l84) for Plexiform Neurofibromas in     Subjects with Neurofibromatosis Type I Age 16 years or greater is for participants that have     been diagnosed with Neurofibromatosis Type 1 (NF1) and have a type of tumor called a     plexiform neurofibroma. Neurofibromas are tumors that develop from the cells and tissues that     cover the nerves. Plexiform neurofibromas can be disfiguring, painful, and life-threatening.     These types of tumors typically do not respond well to most treatment approaches such as     chemotherapy, radiation, and surgery because of their slow growth and location near vital     structures of the body such as nerves, blood vessels, and the airway.      The purpose of this Phase II Study is to determine the response rate of NFI patients with     plexiform neurofibromas treated with Cabozantinib therapy using MRI scans. Cabozantinib is     thought to work on tumors by blocking pathways that are involved in the growth of tumors and     blood vessels that supply tumors. Cabozantinib is considered experimental because it has not     been approved by the Food and Drug Administration (FDA).   "
90483|NCT02101723|"     The investigators propose to study the effects of increased iron intake by home fortification     of complementary foods on the gastrointestinal microbial development, inflammatory responses,     and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic     area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups:     1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test);     Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™     with no micronutrients (placebo). The investigators hypothesize that the microbiome will be     significantly different in the three groups and that Zn absorption and status, in addition to     immune and oxidant status will be improved in the non-Fe fortified groups when compared to     the Fe-fortified group.   "
90484|NCT02101710|"     This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg     in sixty healthy Korean male subjects.   "
90485|NCT02101697|"     This Randomized Controlled Trial has been designed to test the efficacy of a behavioral     intervention to reduce HIV-related stigma among nursing students and ward attendants in 16     sites in South India and 8 sites in North India.   "
90500|NCT02101502|"     This work aimed to prepare the obstetrics and gynecology department for high education and     health care accreditation.   "
90489|NCT02101645|"     The research group will choose no more than 10 patients having a lower extremity venous     ulcer(s), less than 5cm diameter and with an estimated one month time of re-epithelization.     In this study the investigators will follow and monitor the healing of the wound and     effectiveness of compression therapy using bioimpedance measurement based method. The     investigators will also treat the wounds using periodical low intensity direct current (LIDC)     stimulation therapy.      Bioimpedance monitoring and wound stimulation functionalities are provided by a purpose built     wound patch. The patch features a printed 4 x 4 stimulation and impedance measurement     electrodes array (in contact with wound surface) surrounded by a 4-part dual purpose counter     and impedance reference electrodes (in contact with the intact skin surrounding the wound     area).   "
90491|NCT02101619|"     Aortic stenosis (AS) is the most common valve disease in the United States and most common     indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is     insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal     timing of surgical intervention remains critical. However, the changes in structure and     electrical activity of the cardiac muscle can be assessed by noninvasive imaging and     electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or     collagen deposits are frequently observed in AS patients and have a negative impact on     patient outcomes. In this project, our objective is to determine whether echocardiographic     image analysis of integrated backscatter (IB), which can express changes in myocardial tissue     composition (amount of fibrosis) based on its ultrasound reflectivity, global left     ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS     interval have a role in risk stratification for AS patients and to apply those methods to     identify which patients would benefit from surgical intervention.      The investigators hypothesize that 1) the severity of myocardial damage can discriminate the     prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of     the severity of myocardial damage. The investigators will measure the severity of myocardial     fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB     (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be     tested for diagnosing severity of myocardial fibrosis.   "
90492|NCT02101606|"     Rationale The only proven therapy for acute stroke is tPA within 4.5 hours of symptom onset.     This is the standard of care for patients presenting to our hospital within that time frame.     Thrombolysis outside the 4.5 hour window is considered only on experimental or compassionate     grounds. Tenecteplase (TNK) is a genetically modified variant of tPA that has many     theoretical advantages in acute stroke. Studies show that systemic plasminogen activation is     higher after tPA administration, relative to TNK and this is associated with an increased     risk of bleeding events. Imaging cerebral blood flow (CBF) with MRI (perfusion weighted     imaging-PWI) and CT perfusion (CTP) can be performed routinely with standard clinical     scanners. Patients with evidence of large volumes of tissue with low CBF, that is also     structurally intact, as demonstrated by either normal signal on Diffusion weighted imaging     (DWI) or normal cerebral blood volume (CBV) are considered to have penumbral patterns.     Patients with penumbral patterns appear to be the ideal candidates for thrombolytic therapy,     regardless of time from onset.      Study Hypotheses        1. The primary aim of this study is to demonstrate the feasibility and safety of TNK based          thrombolysis in ischemic stroke patients presenting 4.5-24 hours after symptom onset.        2. It is hypothesized that treatment with TNK in patients with penumbral patterns will be          associated with reperfusion, early neurological improvement and penumbral tissue          salvage.      Study Design The study is planned as an open label feasibility and safety study of acute     treatment with TNK in ischemic stroke patients with penumbral patterns evident on advanced     MRI or CT perfusion sequences.      Study Outcomes The primary outcome of this study is a safety endpoint, specifically the     frequency of symptomatic hemorrhagic transformation evident on MRI or CT images on 24 h or     day 5 scans. The ECASS II system for rating hemorrhagic transformation will be applied to all     GRE/SWI images      Significance Current treatment paradigms have not permitted success of tPA to be extended     beyond narrow and limiting therapeutic window of 4.5 hours. Clearly, more effective patient     selection criteria are required. Penumbral imaging is biologically plausible, practical and     has been shown to be predictive of outcome. Application of these imaging techniques to the     acute stroke population is the most promising strategy for extending the therapeutic window     and for introducing superior thrombolytic agents.   "
90493|NCT02101593|"     Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced     Hepatocellular Carcinoma (HCC).   "
90494|NCT02101580|"     Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in     subjects with Advanced Pancreatic Carcinoma.   "
90495|NCT02101567|"     The investigators compare the effectiveness and adverse effects of I.V carbetocin versus     oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean     section.   "
90496|NCT02101554|"     Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine     sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.   "
90497|NCT02101541|"     The FIRM Study Oslo will in two sequential within-patient trials investigate the efficacy of     focal impulse and rotor modulation (FIRM) as a stand-alone procedure in the treatment of     paroxysmal and persistent atrial fibrillation, evaluated by continuous pre- and     post-procedural heart rhythm monitoring.   "
90498|NCT02101528|"     Decreased muscle strength has been reported to be a factor contributing to increased     incidences of falling in the elderly patients causing fractures, joint dislocations, severe     soft tissue lesions and head trauma. Parkinson's Disease (PD) patients often complain of     weakness and it has been reported that they have reduced muscle strength, decreased rate of     force development, impaired ability to maintain constant force, and increased muscle     coactivation during balance perturbation tasks. The specific cause of this weakness is not     known, and in this study the investigators have analyzed and measured isokinetic muscle     strength in PD patients to clarify this issue. The investigators have compared the data     obtained with those of age-matched controls.   "
90499|NCT02101515|"     The hypothesis of this study is that extending the second stage of labor beyond current ACOG     suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United     States is around 30 percent. This is a number that continues to be increasing over the last     few decades and will continue to climb. Each subsequent cesarean section puts the mother and     baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal     placentation, febrile morbidity and death. The most common reason for a cesarean delivery is     a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean     delivery. The aim of this study is evaluate if extending the second stage of labor affects     the cesarean delivery rate and subsequent perinatal morbidity.   "
90504|NCT02101450|"     During cesarean section, it is important to provide hemostasis as well as to decrease the     amount of hemorrhagic fluid and fibrin in the abdominal cavity. Hemorrhagic fluid and fibrin     together may cause adhesion formation and therefore postoperative ileus, retardation in     regaining the gastrointestinal functions as well as prolongation of the operation itself.     Dragging the uterus out of the abdominal cavity during cesarean section before removing the     placenta (extra-abdominal removal of the placenta) may decrease the amount of blood flowing     into the abdominal cavity during removal of placenta. In this study the investigators aimed     to evaluate the influence of intra abdominal vs extra abdominal removal of placenta on     duration of operation, the amount of aspirated fluid during the operation, difference between     postoperative hemoglobin and hematocrit levels, postoperative pain score, additional need of     analgesia, postoperative bowel movements, postoperative endometritis and wound infection.   "
90565|NCT02100657|"     Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in     Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory     Multiple Myeloma.   "
90506|NCT02101424|"     This study will compare the data from pulse oximeters to capnographers as they are used to     monitor patients who are being observed in the Emergency Department for a suspected overdose     of alcohol or other drugs. The investigators will compare monitor data from patients who are     and are not on supplemental oxygen, the ability of the monitors to predict the occurrence of     airway interventions, and to detect ventilator changes noted on the opposing monitor. There     will not be any interventions during this study other than the collection of data from the     monitors and observation of the care of patients.   "
90507|NCT02101411|"     Since thrombus formation is a very complex procedure in vivo, platelet function testing     methods in vitro might only reflect the degree of inhibition of platelet from a certain     level, which do't reflect the functional status of platelets in vivo adequately. There are a     variety of signal transduction pathways involved in the formation of platelet activation and     thrombosis. Gurbel et al. first reported individuals with variability on clopidogrel     treatment response in 2003, and proposed the concept of clopidogrel resistance. Different     patients received the same dose of aspirin or other anti -platelet drug such as clopidogrel ,     due to various reasons bound to lack some patients antithrombotic efforts to increase the     incidence of thrombotic events , while another part of the patient easily understood     antithrombotic excessive bleeding events,  antithrombotic individualized treatment ,      according to differences in patient against platelet drugs or anticoagulant drug reactions     and adjust the treatment plan , is the direction of antithrombotic therapy in the future.      There are a number of studies have shown that patients with no response Clopidogrel ,     measuring the relationship between high platelet reactivity and clinical adverse ischemic     events displayed between platelet activity . However, there is still lack of quantitative     threshold high platelet reactivity and the risks associated with the clinical consensus . In     addition, there are only limited data support, to measure platelet function -based therapy to     improve the clinical efficacy of the concept . Over the years, more than 20,000 cases     reported in patients with numerous studies confirm that high platelet reactivity after PCI     with stent thrombosis , including cardiovascular events , including an increased risk of     significant correlation . Pharmacodynamic analysis GRVITAS trial showed significantly lower     platelet reactivity associated with a lower risk of adverse cardiovascular events . Brar in     more than 3000 cases of patients published in JACC Meta-analysis showed that high platelet     reactivity  of patients whose cardiovascular death, heart attack and stent thrombosis     occurred more than twice the rate of  non-high platelet reactivity  patients .      Two new anti-platelet drugs (Prasugrel and Ticagrelor) in several recent randomized trials     have considerable persuasive , and has included some guidance in the current guidelines.     Ticagrelor even more than Prasugrel in pharmacodynamic studies more effectively inhibit     platelet , and has a lower risk of bleeding. Cilostazol is an old drug , mostly for the     treatment of intermittent claudication , in recent years there are also some testing and     coronary stents prevent restenosis after angioplasty , however, so far , there is little     direct comparison Cilostazol and Ticagrelor related articles .      We designed this test , in addition to testing for high yellow people treat DAPT (dual     anti-platelet therapy) under the platelet reactivity (high on-treatment platelet reactivity)     ratio , this population of patients with ticagrelor instead for a month or cilostazol     treatment after its platelet reactivity changes and compare between the two groups , and even     track six months after the bleeding and adverse cardiovascular events rate? Through this test     we can compare the treatment for patients with high platelet reactivity of what strategies     more appropriate.   "
90508|NCT02101398|"     The aim of this work is to study the effect of transcranial direct current stimulation     combined with naming therapy in acute and post-acute stroke comparing four bihemispheric     positioning electrodes to a sham condition.   "
90509|NCT02101385|"     This study will test the theory that therapy designed for each individual's tumor will     improve outcomes over standard of care in a population that needs a better standard.   "
90510|NCT02101372|"     The AGES-CM consortium aims to study the interaction between the polymorphisms of the     candidate genes related with neurodevelopment, neurotransmission, brain progressive changes,     cognitive functioning and stressful life events (prospective- and retrospectively assessed)     and the association of the interactions with structural and functional brain measures,     neuropsychological performance, biochemical and oxidative status in both in patients and     controls. The investigators study aimed to examine the effectiveness of a parallel,     structured, and specific psychoeducational group intervention (PE) for adolescent patients     and their families by comparing it with treatment as usual).   "
90511|NCT02101359|"     The purpose of this study is to determine the efficacy and safety assessment of T2380 for     mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group     (topical mydriatics and anaesthetic) 2X246 patients.   "
90512|NCT02101346|"     The aim of the present study is to identify the effects of different dietary fats on the     body's immune system and how different types of cells respond. There will be two rounds of     recruitment in order to satisfy different aims of the study. In the first round, volunteers     will be asked to undergo five separate 1-day assessments where you will be given diets in the     form of milkshakes differing in amounts of fats. Volunteers recruited for this round will     also be given the opportunity to participate in the second round of recruitment and feeding.     A second round of recruitment will then take place to complete recruitment, if required. In     the second round, volunteers will be asked to undergo two separate 1-day assessments in the     form of milkshakes with differing fats, one of which will contain a tracking label added to     the food during preparation. This label is in the form of is a 'stable isotope' and safe to     consume (used commonly in some medical tests - see below for further information) and will     allow the researchers to later find the food particles within blood cells. During these 1-day     assessments blood samples will be collected to identify the impact different diets have on     the immune system, specifically monocyte cells thought to play an important role in the     development of atherosclerosis, a primary cause of cardiovascular disease.   "
90513|NCT02101333|"     First-line tocilizumab treatment during 6 months could permit rapid steroid-tapering and     induction of remission in Takayasu arteritis (TA).   "
90514|NCT02101320|"     In France, breast cancer affects approximately 53,000 new cases per year. The investigators     have to take care more and more women with subclinical lesions (nonpalpable), and it     represents around 25% to 35% of the diagnosed breast cancers. The main problem of the     surgical management of these lesions is the quality of preoperative identification which     determines the quality of surgery and oncological and cosmetic outcomes. For this type of     lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed.     This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The     investigators want to evaluate the potential benefits of using a hand held camera called     TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside     and in the operating theater.   "
90515|NCT02101307|"     This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in     patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment     regimen will be directed by the treating physician according to clinical practice. Patients     are expected to be observed for approximately 6 months after beginning treatment.   "
90651|NCT02099539|"     This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation     study of ALT-803 in patients with relapsed or refractory multiple myeloma.   "
90516|NCT02101294|"     The study hypothesis is that there is a relationship between the keyboard layout and carpal     tunnel syndrome (CTS). Specifically, use of the standard QWERTY keyboard increases the risk     of symptoms of carpal tunnel syndrome. The QWERTY keyboard requires more effort by the     fingers than necessary to perform the required work, i.e. data or word entry; up to 200     percent more flexion and extension and 100 percent more distance traveled.      The purpose of the protocol is to evaluate two keyboard layouts for carpal tunnel syndrome     therapy, and to see if the efficient keyboard, Finger Relief, can be used as an adjunctive     tool to other treatments or therapy for CTS for typists. Subjects who had received a     diagnosis of carpal tunnel syndrome from their medical doctor and, where not contraindicated,     had received confirmation of the diagnosis of carpal tunnel syndrome with a nerve conduction     velocity (NCV) study participated in four typing sessions to compare onset and severity of     carpal tunnel symptoms. Testing sessions alternated between keyboards. The keyboard selected     for the first typing session was determined by random assignment. Twenty subjects completed     all four typing sessions. The test protocol consisted of a medical history, 3 tests of the     subjective pain experience of the subject (visual analogue scale / verbal rating scale, and     hand diagram), 2 clinical measures of physical manifestations of swelling associated with     carpal tunnel syndrome (water volume/tape measure), and a measure of the length of time spent     typing on each keyboard layout - QWERTY and TheOrdinals (the Finger Relief keyboard).   "
90517|NCT02101281|"     The purpose of the study is to assess the efficacy and safety of different doses of rhNGF     when administered as eye drops to patients with Dry Eye.   "
90566|NCT02100644|"     The purpose of this study is to examine whether the VPA (Valproate) dose can be reduced by     additional administration of LTG (Lamotrigine) in Japanese pre-menopausal female epilepsy     patients aged 15 years or older, whose seizures are well controlled by VPA monotherapy.   "
90518|NCT02101268|"     This study is to determine the efficacy of momelotinib (MMB) versus best available therapy     (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or     post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who     were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).      Participants will be randomized to receive either MMB or BAT for 24 weeks during the     randomized treatment phase, after which they will be eligible to receive MMB in an extended     treatment phase for up to an additional 204 weeks. After discontinuation of study medication,     assessments will continue for 12 additional weeks, after which participants will be contacted     for survival follow-up approximately every 6 months for up to 5 years from the date of     enrollment or until study termination. For those subjects planning to continue treatment with     MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival     follow-up visits are not required.   "
90519|NCT02101255|"     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the     treatment of early approximal carious lesions compared to fluoride.   "
90520|NCT02101242|"     A total of 60 patients will be enrolled in the study: 20 each who receive surgery in beach     chair position or Trendelenburg's position and 20 patients undergoing cardiac surgery.     Regional cerebral oxygen saturation will be measured continuously during surgery. Duration     and extent of deviations from individual baseline values will be recorded and detected     deviations treated according to their clinically apparent cause (e.g.     hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with our standard     operating procedures (SOPs).      Patients are then followed up until the end of hospital stay or for a maximum of 10 days     after surgery. Their level of cognitive function will be tested and compared to the data     acquired before surgery to detect impairment, delirium or postoperative cognitive deficit     (POCD).      The purpose of this pilot study is to evaluate the design and conduct of a projected full     scale observational clinical study.   "
90521|NCT02101229|"     To assess whether the DIABELOOP algorithm provides better glycemic control than the usual     algorithm of T1D patients on pump therapy:        -  at meals, with CHO roughly assessed by the patient.        -  during and after physical activity sessions qualified as moderate by the patient.      Primary endpoint : time within the glycemic reference range. The study will be conduct with     15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and     CHU of Montpellier.   "
90522|NCT02101216|"     Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis,     termed Prurisol™, which is an ester of abacavir. This first-in-human study of Prurisol     (abacavir acetate) is being performed to evaluate the pharmacokinetics, safety and tolerance     of a single oral doses of Prurisol administered to healthy volunteers and the bioequivalence     to abacavir sulfate (Ziagen). This study will be followed by a 505(b)(2) Phase 2 trial in     patients with moderate to severe plaque psoriasis.   "
90523|NCT02101203|"     A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety     and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive     sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.      This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to     study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in     healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s).     Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours     after each sexual activity. The following hypotheses will be tested:      Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual     events.      Objectives:      To investigate the efficacy of Lybridos as compared to placebo in increasing the number of     satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire     disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms        -  To identify the optimal dose of Lybridos to take into phase 3 clinical development        -  To confirm that Lybridos has superior efficacy as compared to testosterone alone and to          buspirone alone        -  To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or          sexual desire/arousal        -  To evaluate the safety profile of Lybridos   "
90524|NCT02101190|"     The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients     with moderate chronic hepatic impairment and in matched healthy subjects.   "
90525|NCT02101177|"     The aim of the study is to analyse data coming from two treatment centres of the National     Treatment Program Centres of hepatitis C in Egypt   "
90526|NCT02101164|"     This study will estimate the total time for the preparation and administration of denosumab     and the total time for the preparation and administration of pamidronate.   "
90527|NCT02101151|"     The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both     nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels     may be inversely related to the prevalence of diabetes, insulin resistance and metabolic     syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism,     evidence from randomized and adequately powered placebo-controlled intervention trials is     needed.The trials available on the effect of Vitamin D supplementation are not conclusive.     Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D     deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D     supplementation on glycemic control and obesity parameters.   "
90540|NCT02100982|"     The goal of this study is to develop and test Customized Care, an intervention to help     patients dealing with depression and/or anxiety in the context of multiple chronic     conditions. Customized Care is designed to help patients communicate about important issues,     such as financial and safety concerns, with their primary care providers (PCPs). The     intervention will be delivered in patient waiting rooms prior to a routine follow-up visit     with the PCP. Phase 1 of the project will ensure that the main components of Customized Care     are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects     of Customized Care on patient-PCP communication.      Participants aged 40 years or older who have a diagnosis of two or more common chronic     medical conditions will be recruited from primary care clinics. Patients screening positive     for either depression or anxiety will be randomized to Customized Care vs. an active control.      The investigators hypothesize that the Customized Care will improve patient-Primary     Care-Provider communication.   "
90528|NCT02101138|"     Background:      - Eosinophils are white blood cells that fight infections. In people with hypereosinophilic     syndrome (HES), eosinophil levels are too high and can damage their organs. HES is usually     treated with steroids, but steroids can cause side effects and stop working over time.     Researchers want to see if a drug called dexpramipexole, being developed by Knopp     Pharmaceuticals, can help people with HES to reduce their steroid dose.      Objective:      - To test whether dexpramipexole can reduce the steroid dose needed to control eosinophilia     and HES symptoms.      Eligibility:      - Adults 18 and older with HES who respond to steroids, but need more than 10 mg daily to     control eosinophilia and symptoms.      Design:        -  The study will last 9 months with 6 visits to NIH.        -  Participants will be screened with medical history, physical exam, and urine and blood          samples.        -  Participants steroids will be tapered to the lowest effective dose. During this time,          blood will be drawn weekly. Participants will take this dose for 2 weeks before starting          the study drug.        -  Participants will take the study drug twice daily by mouth for 12 weeks along with          steroids. The steroid dose will not be decreased during this time and participants will          be seen monthly for a medical history, physical examination and blood work.        -  Just before and 12 weeks after starting the study drug, the following tests will be          performed:        -  medical history and physical exam        -  blood and urine tests        -  lung function tests        -  electrocardiogram (measures heart electrical activity)        -  echocardiogram (takes pictures of the heart using sound waves)        -  bone marrow biopsy (a needle inserted into the hip bone that removes bone marrow cells          for study)        -  After 12 weeks, the participants steroid dose will be tapered again to the lowest          effective dose while on study drug.        -  Two weeks after the lowest effective dose is reached, participants will return for a          medical history, physical examination, blood work, lung and heart tests.        -  Participants who respond to the study drug may be able to continue to receive the drug          on a planned separate study.        -  Four weeks after stopping the study drug, participants will have medical history,          physical exam, and blood tests.   "
90529|NCT02101125|"     The purpose of this study is to evaluate the effect of concomitant administration of     BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.   "
90530|NCT02101112|"     The purpose of this study is to determine whether the bioavailability of apixaban crushed     tablets suspended in water or mixed with applesauce is similar to the bioavailability of     apixaban whole tablets administered orally.   "
90531|NCT02101099|"     The aim of the study is to determine if more force is used during colonoscopy when patients     receive monitored anesthesia with propofol versus conscious sedation. Force measurements will     be performed using the colonoscopy force monitor (CFM). This device measures the magnitude     and direction of force applied to the insertion tube of a standard colonoscope during     colonoscopy.   "
90532|NCT02101086|"     The purpose of this study is to investigate the efficacy and safety of autologous cord blood     transfusions in very-low-birth-weight premature infants, and to evaluate the developmental     outcomes of the infants who received autologous transfusions.   "
90533|NCT02101073|"     The overall aims of the study are:        -  To assess the bioavailability of single doses of ALX-0061, administered s.c. at three          dose levels, using 2 corresponding single i.v. dose levels as reference.        -  To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.        -  To further determine the safety and tolerability of ALX-0061.        -  To further evaluate the systemic (serum) immunogenicity of ALX-0061.   "
90534|NCT02101060|"     Research is needed to determine safe and effective exercise rehabilitation programs to     prevent and improve physical disability in older adults living with HIV. This problem is of     great importance to the VA. The majority of the 25 thousand HIV-infected veterans are over 50     years of age (64%). The combined effect of aging and inflammation increase the risk for     physical disability in older HIV-infected veterans. This translational exercise training     trial will examine the cardiac and skeletal muscle effects of combined aerobic exercise and     resistance training to attenuate the functional declines of aging with HIV by reducing the     deleterious consequences of chronic inflammation. Findings will guide future rehabilitation     research on cardiac remodeling and inflammation of skeletal muscle. The proposed research     will advance the goal to develop effective rehabilitation strategies that improve the health     of older HIV-infected veterans.   "
90535|NCT02101047|"     Three different regimens of phenylephrine are being evaluated to see if one is superior over     the other in the maintenance of cardiac output while keeping normotension and/or treating     hypotension experienced when receiving spinal anesthesia for cesarean delivery.   "
90536|NCT02101034|"     The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991     given with cetuximab and evaluated the side effects of the combination.   "
90537|NCT02101021|"     There will be two phases to this study. The lead-in phase will evaluate the safety,     pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib combined with     nab-paclitaxel and gemcitabine in adults with previously untreated metastatic pancreatic     ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and     tolerability of nab-paclitaxel and gemcitabine combined with either momelotinib administered     at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal     adenocarcinoma as measured by improvement in overall survival (OS), progression free survival     (PFS), and overall response rate (ORR). Participants will continue study treatment until     disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of     treatment. Following treatment, participants will be followed for safety for 30 days and for     survival approximately every 3 months for up to 3 years.   "
90538|NCT02101008|"     Primary Objectives Determine the response rate associated with treatment of refractory     disseminated malignant melanoma with disulfiram and chelated zinc.      Secondary Objectives Determine the progression-free survival associated with treatment of     refractory disseminated malignant melanoma with disulfiram and chelated zinc.      Determine the overall survival associated with treatment of refractory disseminated malignant     melanoma with disulfiram and chelated zinc.      Determine the toxicity associated with treatment of refractory disseminated malignant     melanoma with disulfiram and chelated zinc Determine the effect of disulfiram and chelated     zinc on in vivo protein S-glutathionylation.   "
90698|NCT02098928|"     Main objective: to compare the effects of hand-acupuncture and electro-acupuncture     stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the     safety and acceptability of hand acupuncture and electroacupuncture stimulation   "
90539|NCT02100995|"     The purpose of this study is to determine whether an integrated behavioral treatment approach     can help overweight or obese individuals who also have chronic pain reduce their weight and     manage their pain symptoms. The goal of this research is to develop better treatments for     individuals with chronic pain and overweight or obesity. All participants in this study will     receive treatment for weight management and/or pain symptoms. Participants will be assigned     at random (like we picked it blindly out of a hat) to receive either: (1) Standard behavioral     treatment for weight loss; or (2) Standard behavioral treatment for pain management; or (3)     Integrated behavioral treatment for weight loss and pain.   "
90541|NCT02100969|"     The purpose of this study is to determine whether Hizentra is a safe and effective treatment     for people with myasthenia gravis (MG).   "
90546|NCT02100904|"     The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA     Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF     ablation (Acessa).      The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone     laparoscopic RF ablation (Acessa) within the United States. Participants will be recruited     through study materials distributed at clinical offices across the country where     gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will     consent to participate in a 3 year prospective study conducted by UCSF but the laparoscopic     RF ablation (Acessa) surgery will be performed by the study participants' own gynecologist.     We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18,     24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA     (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA     (Acessa) procedure. Participants will be asked for permission to review their medical records     to assess surgical and pregnancy outcomes. The gynecologists performing the laparoscopic RF     ablation (Acessa) surgery will be asked to consent to complete a brief study questionnaire     with information on demographics, work history, professional training, and practice setting.      UC San Francisco will have oversight of all scientific and administrative aspects of the     study. All study data will be stored securely in a HIPAA compliant, secure database monitored     by the UC San Francisco Coordinating Center.   "
90547|NCT02100891|"     The investigators hypothesize that this Phase 2 cellular and adoptive immunotherapy study     using human leukocyte antigen (HLA)-haploidentical hematopoietic cell transplantation (HCT)     followed by an early, post-transplant infusion of donor natural killer (NK) cells on Day +7     will not only be well-tolerated in this heavily-treated population (safety), but will also     provide a mechanism to treat high-risk solid tumors, leading to improved disease control rate     (efficacy). Disease control rate is defined as the combination of complete (CR) and partial     (PR) response and stable disease (SD). The investigators further propose that this infusion     of donor NK cells will influence the development of particular NK and T cell subtypes which     will provide immediate/long-term tumor surveillance, infectious monitoring, and durable     engraftment.      Patients with high-risk solid tumors (Ewings Sarcoma, Neuroblastoma and Rhabdomyosarcoma) who     have either measurable or unmeasurable disease and have met eligibility will be enrolled on     this trial for a goal enrollment of 20 patients over 4 years.   "
90548|NCT02100878|"     Physical exercise has been shown to significantly reduce subsequent energy intake in obese     adolescents but not in lean, without altering their appetite feelings. Although previous     studies have pointed out the role of gastric peptides in this post exercise nutritional     response, some recent work question the role of the neural system in the post exercise drive     to eat. This study tends to explore whether or not an acute bout of exercise can affect the     neural response to food cues in adolescents, obese or lean.   "
90549|NCT02100865|"     Globally, approximately 2.1 million children die of pneumonia each year. Most deaths occur in     resource-poor settings in Africa and Asia. Oxygen (O2) therapy is essential to support life     in these patients. Large gaps remain in the case management of children presenting to African     hospitals with respiratory distress, including essential supportive therapies such as     supplemental oxygen. We hypothesize that a novel strategy for oxygen delivery, solar-powered     oxygen, can be implemented in remote locations and will be non-inferior to standard oxygen     delivery by compressed gas cylinders.   "
90550|NCT02100852|"     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in     combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic     leukemia.   "
90823|NCT02097303|"     This is an open label study designed to examine the effects on concurrent administration of     Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic     castrate resistant prostate cancer and with bone metastases, in both the pre- and post-     chemotherapy setting. Both medications are approved by the US Food and Drug Administration     for this indication.   "
90551|NCT02100839|"     The purpose of the first part of this study is to determine the safety and tolerability of a     single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol     who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will     also be evaluated.      The second part of this study will be a multiple ascending dose evaluation of AEM-28 in     patients with refractory hypercholesterolemia.      AEM-28 has demonstrated significant lipid lowering activity and positive effects on the     artery wall. AEM-28 is being developed for the treatment of homozygous familial     hypercholesterolemia.   "
90552|NCT02100826|"     The purpose of this study is to compare two different preparations of an antibiotic called     cephalexin to determine if they are essentially the same. The study has two periods.     Participants will receive one preparation of cephalexin in each period. At least 7 hours will     pass between the study periods. The study is expected to last about 2 days for each     participant, not including screening or follow-up.   "
90553|NCT02100813|"     To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two     consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily     treatment for two consecutive days compared to vehicle   "
90554|NCT02100800|"     Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD).     Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of     COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema     but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort     echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our     objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the     agreement between both techniques.   "
90555|NCT02100787|"     The objective of the study is to see if there is a change in tear osmolarity over time when     moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.   "
90556|NCT02100774|"     The aim was to identify minor genetic variations (single nucleotide polymorphisms) that     explain the interindividual variability in bioavailability of fat soluble micronutrients (fat     soluble vitamins and carotenoids).   "
90557|NCT02100761|"     To investigate the relationship between cytochrome P450 (CYP) 2C19 genetic polymorphism and     the steady-state blood concentration of voriconazole in Chinese patients with invasive     pulmonary aspergillosis (IPA), and to assess the effects of voriconazole trough concentration     on the prognosis of IPA patients.   "
90569|NCT02100605|"     Phytosun decongestant nasal spray is a class I medical device registered in the European     Union for the treatment of nasal congestion. The spray contains hypertonic seawater and     essential oils. The objective of the study is to investigate the effects of a nasal spray,     registered as a medical device under the name Phytosun Decongestant in the European Union, on     speed of onset of relief of nasal congestion in 50 subjects suffering from nasal congestion     associated with common cold.   "
90570|NCT02100592|"     Severe brain injuries induce alteration of state of consciousness. These functional     limitations can be significantly alleviated by treatment neurorehabilitation, particularly if     this is established early. It has been shown that treatment of vertical integration in     patients in a vegetative state or minimally conscious state can improve the level of     supervision and positive influence on rehabilitation. Therefore, there are sufficient     indications that anticipate the treatment of vertical integration, since the phase of     hospitalization in ICUs, may improve the functional outcome of the patient.   "
90571|NCT02100579|"     Total knee arthroplasty is associated with intense early postoperative pain. Fast track     recovery programs including early therapy protocols and early hospital discharge are being     implemented at various hospitals. The postoperative analgesic pain regimen should enhance     functional recovery in addition to providing efficient analgesia with minimal side effects.     Adductor canal blockade is commonly used to provide postoperative analgesia for total knee     arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor     canal block will lower narcotic consumption and improved overall satisfaction compared to     ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally     invasive TKA surgery.   "
90572|NCT02100566|"     People with life-limiting illness often receive more aggressive healthcare than desired     including costly procedures that provide little medical benefit. Advance Directives (AD) can     reduce this effect but various factors limit their adoption.      A randomized trial will target hospitalized patients with a serious, life limiting illness to     test if the behavioral economics principles of endowment (possessing something) and focusing     (featuring something important to patients) can motivate AD completion. Investigators will     examine if offering patients an AD by default, in combination with framing the rationale for     AD completion (emphasizing patient control or caregiver burden) improves AD completion and     family conversation compared to a no-intervention group. The study hypothesis is to determine     if rates of AD completion and family conversations will be highest among patients receiving     the intervention focused on reduced caregiver burden; and if the two intervention groups will     have higher rates of both than the control group.      The investigators suspect that a small change in how patient information is framed (endowment     and focusing used in tandem) will potentially leverage large increases in AD completion and     that targeting HHC patients allows AD discussions early in the disease trajectory when they     can participate in care decisions.   "
90573|NCT02100553|"     This study will assess if itraconazole will affect the blood levels of Duavee when they are     given together. This study will also assess if a subject's body size affects the blood levels     of Duavee.   "
90574|NCT02100540|"     Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal     women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause     hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is     proposed to have effect on reduciton of hot flashes through its dopaminergic and serotonergic     antagonism. The primary purpose of this study is to determine if RCN3028 is effective and     safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with     the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot     flashes per day, or 50 per week at baseline.   "
90575|NCT02100527|"     This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157     administered for 6 weeks in subjects with moderate to severe acne vulgaris.   "
90576|NCT02100514|"     This study is a multicenter, double-blind, randomized study to access the efficacy, safety     and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia     receiving background statin therapy.   "
90577|NCT02100501|"     The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the     classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually     3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by     many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified     atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to     propose a less restrictive dietary treatment that would be more palatable to children and     adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30%     protein, and 10% carbohydrates by weight), without any restriction on the recommended daily     calories. Some literature suggested that the MAD is an effective treatment for refractory     epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this     prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD.     The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled     patients were randomly assigned to either one of two groups; the KD group and MAD group. The     patients were required to attend outpatient clinic after 1, 3month to record their seizure     frequency and severity, while their dietary treatment.   "
90590|NCT02100332|"     The purpose of this study is to establish the prevalence of comorbidities in Italian patients     with chronic bronchitis with at least 2 exacerbations per year, and to document the     appropriateness of instrumental diagnostic tests, such as spirometry of these patients.   "
90591|NCT02100319|"     The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets)     in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be     sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than     azilsartan, in routine clinical practice   "
90607|NCT02100111|"     This multi-center, observational study involves reviewing the medical records of     approximately 100 adult participants diagnosed with advanced BCC from 01 January 2005 until     31 December 2010. Participant records will be analyzed to identify participant     characteristics, treatment patterns and clinical outcomes.   "
94095|NCT02054455|"     The aim of the study is to evaluate the potential protective effect of Lactobacillus     paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with     gastro-esophageal reflux disease at long-term PPI treatment.   "
90578|NCT02100488|"     Achieving near-normoglycemia has been established as the main objective for most patients     with diabetes. However, postprandial glucose control is a challenging issue in everyday     diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors     to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the     poor reproducibility of postprandial glucose response is burdensome for patients and     healthcare professionals.      Automatic glucose control, the so-called artificial pancreas or closed-loop system, may     represent the ideal solution for reaching the therapeutic goals in diabetic patients.     Intuitively, closed-loop insulin delivery may be superior to open-loop insulin delivery due     to a better compensation of the variability of subcutaneous insulin absorption and the     intra-subject insulin sensitivity. However, several challenges exist to effectively realize     an optimal postprandial closed-loop control of blood glucose. Indeed, the eating process     induces one of the major glucose perturbations that need to be controlled by an artificial     pancreas and is currently one of the main challenges found in clinical validations of the few     existing prototypes of an artificial pancreas. In particular, experiments carried out with     the currently used algorithms for glucose control (the so called PID and MPC) showed that     closed-loop insulin delivery often tend to overcorrect hyperglycemia thus increasing the risk     hypoglycemia.      In this project, a rigorous clinical testing of a novel closed-loop controller ('artificial     pancreas') will be carried out in T1DM patients treated with continuous subcutaneous insulin     infusion (CSII). The innovative element of the controller is a safety auxiliary feedback     based on sliding mode reference conditioning (SMRC), which has been demonstrated (in     simulation studies) to limit over-insulinization and the resulting hypoglycemia, reducing     glycaemic variability.      Standardized meal test studies will be performed in T1DM subjects treated with CSII,     comparing the administration of a classical bolus (open-loop study) with a controller-driven     prandial insulin delivery (closed-loop study) based on continuous subcutaneous glucose     monitoring (CGM).      The hypothesis is that closed loop control will provide better postprandial control,     especially in terms of reduction of glucose variability and incidence of hypoglycemia.   "
90579|NCT02100475|"     This trial is conducted globally. The aim of the trial is to compare sequential addition of     insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects     with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and     metformin and in need of further intensification.      This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).   "
90580|NCT02100462|"     This will be a randomized, double-blinded, three-period crossover study of platelet     activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone     (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is     that CTD has different effects on platelet activation and aggregation than HCTZ.   "
90582|NCT02100436|"     This is a Phase II open-label study in approximately 240, and up to 400, healthy males and     non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety,     reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21     days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine     manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100     subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately     60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly     as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100     subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as     7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject     will be approximately 7 months.   "
90583|NCT02100423|"     This phase II trial studies the efficacy (activity), and tolerability of curcumin and     cholecalciferol combination in treating patients with previously untreated stage 0-II chronic     lymphocytic leukemia or small lymphocytic lymphoma. Curcumin and cholecalciferol may prevent     or slow the growth of cancer cells.   "
90584|NCT02100410|"     The purpose of this study was to evaluate the axis location of toric contact lenses after 3     minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of     various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30     minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with     embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without     embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.   "
90585|NCT02100397|"     Enteric fever is responsible for over 20 million illnesses and 200,000 deaths each year. S.     Paratyphi A accounts for a substantial and increasing proportion of these cases, as high as     90% in some regions of Asia. There are currently no vaccines directed against S. Paratyphi A,     although there some candidates in preclinical and phase 1 trials. This study is funded by the     European Vaccine Initiative and the Bill and Melinda Gates Foundation. Paratyphoid is a     human-restricted infection, for which there are currently no small animal models available.     In order to further our understanding of the host-pathogen interactions, this study will     develop a novel human challenge model in which to investigate this infection, using a recent     successful typhoid challenge model as its template.      Healthy subjects to ingest a dose of Salmonella enterica serovar Paratyphi A, strain NVGH308,     after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish whether     each participant meets clearly defined criteria for diagnosis of paratyphoid infection.     Statistical analysis will be performed on this outcome will determine if it consistently     gives an attack rate of 60 to 75%. If this is not reached with the first cohort of 20     participants, the dose will be escalated and the process repeated. A maximum of 80     participants will be enrolled. Total follow up will be over the course of one year.     Descriptive clinical and laboratory data collected from participant observations, samples of     blood, faeces, urine and saliva will allow insights into the disease and the host response.     These insights will forward our knowledge of paratyphoid disease and may help discover or     develop diagnostic methods.      This study is funded by the European Vaccine Initiative and the Bill and Melinda Gates     Foundation. Paratyphoid is a human-restricted infection, for which there are currently no     small animal models available. In order to further our understanding of the host-pathogen     interactions, this study will develop a novel human challenge model in which to investigate     this infection, using a recent successful typhoid challenge model as its template.      Healthy subjects will ingest a dose of Salmonella enterica serovar Paratyphi A, strain     NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish     whether each participant meets clearly defined criteria for diagnosis of paratyphoid     infection. Statistical analysis will be performed on this outcome will determine if it     consistently gives an attack rate of 60 to 75%. If this is not reached with the first cohort     of 20 participants, the dose will be escalated and the process repeated. A maximum of 80     participants will be enrolled. Total follow up will be over the course of one year.     Descriptive clinical and laboratory data collected from participant observations, samples of     blood, faeces, urine and saliva will allow insights into the disease and the host response.     These insights will forward our knowledge of paratyphoid disease and may help discover or     develop diagnostic methods. Anticipating the development of a successful live challenge model     through this study, there will be the possibility of evaluating novel paratyphoid vaccines     that are currently in early clinical phase testing. This serves an important function because     field trials in endemic areas are expensive and time consuming. Speeding up this process     using our model will be of great benefit to endemic areas.   "
90586|NCT02100384|"     Nowadays, dental implants are a very attractive and affordable treatment option for patients.     According to the American Society of Implant Dentistry the dental implant market in the U.S     is projected to reach $1.3 billion by 20101. Despite the high success rates of dental     implants, it is clear that osseointegrated implants are susceptible to diseases. The     prevalence of dental implant complications are rising as the number of individuals that are     receiving implant treatment is also increasing. One of these peri-implant complications is an     inflammatory condition known as peri-implant mucositis that occurs in 64.6% to 80% of the     implant population.      The lack of preventive maintenance therapy in subjects with peri-implant mucositis is     associated with a high incidence of peri-implantitis, which eventually may lead to implant     loss. One important method in the prevention of peri-implant mucositis is the reduction in     plaque accumulation, through individual oral hygiene procedures and regular peri-implant     professional maintenance. It is highly important that patients be educated about the     importance of developing good oral hygiene habits and to attend regular periodontal     maintenance appointments. The clinicians have to recognize the significance of monitoring and     maintaining peri-implant health.      Unfortunately, it is unclear which of the different maintenance regimens and treatments     strategies for peri-implant mucositis and peri-implantitis are more effective. There is lack     of information about which peri-implant maintenance protocol offers the best outcome in terms     of reduction of inflammation and improved patient comfort. According to Grusovin et al,     there is only low quality evidence for which are the most effective interventions for     maintaining or recovering health of peri-implant soft tissues and there is no reliable     evidence as to which regimens are most effective for long term maintenance. Moreover,     current approaches to implant maintenance are somewhat haphazard and not standardized.      It is assumed that what is appropriate for teeth is also beneficial for implants; as stated     by Persson et al, 2010 therapies proposed for the management of peri-implant diseases are     currently based on the evidence available from the treatment of periodontitis. Two     conventionally used methods of biofilm and calculus removal from teeth in North America are     hand instruments (curettes and scalers) and ultrasonics. In teeth these two modalities of     treatment have been studied extensively; conversely, there are fewer studies on dental     implants. Renvert et al, 2008 concluded that mechanical non-surgical treatment might be     effective to treat peri-implant mucositis but not peri-implantitis; however, the data     supporting this literature review was scarce. The same research group compared ultrasonic     instrumentation with specific-implant tips to titanium curettes in the treatment of     peri-implantitis founding no group differences in the treatment outcomes with improvements in     plaque and bleeding scores but no effects on probing depths. In addition, both methods failed     to eliminate or reduce bacterial counts and no group differences were found in the ability to     reduce the microbiota in a six months period.      One of the main concerns for dental implants is that metal scalers and ultrasonics generate a     roughened surface on the implant, which in turn facilitates plaque accumulation and therefore     makes maintenance of plaque free surfaces more difficult. It was observed in a recent study     that special coated scalers and ultrasonic tips have been shown in vitro to be compatible     with implant surfaces, however this has not been confirmed in vivo. The previous finding is     in agreement with a current study, which demonstrated that the roughness values of the     titanium surface of implants treated with piezoelectric ultrasonic scalers with a newly     developed metallic tip and plastic hand curettes, are equal to the surface's roughness of     untreated implants. Mann et al, 2012 showed in an in vitro study that plastic-coated scalers     cause minimal damage to the implant surface but leave plastic deposits behind on the implant     surface, suggesting further research is needed to evaluate the use of such plastic tips in     the debridement of implants.      An additional factor, in evaluating the efficacy of different instrumentation in peri-implant     maintenance, which needs to be taken into consideration, is patient perception. There is     currently no data evaluating patient perception of comfort in regards to hand vs. ultrasonic     instrumentation. This information is very important because should both methods of     debridement be considered of equal efficacy, patient preference may play a role in the     practitioner's selection of instrumentation. Knowing that patient comfort will increase the     patient's compliance to the maintenance therapy, further evaluation of this factor is     necessary.   "
90587|NCT02100371|"     This is an extension study of Protocol CA194002 to allow 2 specific participants with basal     cell nevus syndrome in the CA194002 study at Princess Margaret Cancer Centre who are still     benefitting from the study drug BMS-833923 to continue receiving the study drug. This study     will continue to evaluate the safety and tolerability of BMS-833923 in these participants.   "
90588|NCT02100358|"     Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an     accurate method of diagnosing acute cholecystitis.   "
90589|NCT02100345|"     Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of     abdominal pain and suffering during women's menstrual periods. A subgroup of patients with     DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth     pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to     assess the need for follow-up with transvaginal ultrasound during medical treatment.      Hypotheses:      Symptoms will follow growth of rectosigmoid endometriosis.      Material and methods:      Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and     treatment with hormonal intrauterine device or continuous oral contraceptives will receive a     questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion,     (6) and 12 months later.      Perspectives:      Patients treated conservatively may be followed by questionnaires, thereby reducing the need     for time consuming clinical controls.   "
90592|NCT02100306|"     Stroke is one of the leading causes of disability, with an estimated prevalence of 50,000     cases per year in Canada. Less than half of stroke patients regain use of their arm and hand.     There is currently no intervention regime that is the gold standard, despite the variety of     therapeutic techniques used to treat the upper extremity post-stroke. The use of external     feedback to improve motor learning is a technique that has been less studied but shows     promise. Therefore, the purpose of this proof of principle study it to test whether different     auditory feedback frequencies can facilitate reaching ability in people with stroke. In     addition brain scans will be collected that will enable us to determine how stroke severity     may impact on one's ability to improve with this technique.      We hypothesize that patients who receive less feedback (50% alternate) will have enhanced     learning relative to the patients who receive more feedback (100%).   "
90593|NCT02100293|"     This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose     rocuronium, intubation condition and surgical condition.   "
90824|NCT02097290|"     This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left     Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy     Defibrillator (CRT-D) devices.   "
90825|NCT02097277|"     The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults     with type-2 diabetes.   "
90594|NCT02100280|"     This study is a multicenter, randomized, controlled, double-blinded, and parallel design     study. A total of 96 patients were decided to be recruited considering a 10% dropout rate.     Patients are randomized to receive a deep block or a moderate block. The randomization     numbers are generated using a computer-generated randomization code (1) and are sealed in the     opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia     management after the induction of anesthesia. Patients, surgeons reporting the scale of     surgical status, and another researcher analysing the cytokines levels are blinded to the     patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective     laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease,     hepatic or renal function impairment, on medications affecting neuromuscular function, and     with known allergy to the drugs to be used are excluded.   "
90595|NCT02100267|"     The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride     challenge test in diagnosis of adult asthma   "
90596|NCT02100254|"     This randomized clinical trial studies narrative or fact-based videos in increasing     colorectal cancer screenings in African American communities. Informational videotapes may     help increase the number of participants who engage in colonoscopy screenings. It is not yet     known whether narrative videos may be more effective than fact-based videos in increasing     colorectal cancer screenings.   "
90597|NCT02100241|"     The purpose of this study is to determine whether active stretching with low frequency     currents are more effective than active stretching in the treatment of hamstring shortness     syndrome in children.   "
90598|NCT02100228|"     Some people can develop an abnormal heart beat known as Atrial fibrillation or AF that     puts them at risk of developing clots in the heart. Those clots can travel in the blood     circulation to the brain and cause a brain attack (a stroke). To prevent those clots     forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by     stopping one of the blood substances required for clotting (Factor Xa). It is approved and     used to prevent clots forming in people with AF. Other established blood thinners work by     stopping clotting substances being made, known as Vitamin K antagonists or VKAs. An     example of this type is Warfarin (Coumadin). The good effects of all blood thinners are     preventing clots, and they may also have bad effects of increasing the chance of bleeding.     People with AF, abnormal heart beat, may benefit from changing it back to a normal regular     rhythm, known medically as cardioversion. When this is done, people are currently most     commonly treated with a VKA blood thinner (e.g. warfarin). The purpose of this study is to     assess the good and bad effects (efficacy and safety) of apixaban compared with warfarin     in people with AF in whom an early cardioversion is planned.   "
90599|NCT02100215|"     The purpose of this study is to learn more about the effects of various types of simulation     preparation methods on novice nurses' competence and self-efficacy. Participants will be     recruited from an academic course (N424 Integrated Practicum). Participants will be     randomized to three intervention groups (i.e. expert modeling video, voice over PowerPoint,     and traditional readings). All participants will complete self-efficacy surveys and two     simulations. During simulation, participants will be scored based on their competence     according to a performance rubric. The hypothesis is that participants in the expert modeling     group will demonstrate more change in competence and report more change in self-efficacy     scores than participants in other groups.   "
90600|NCT02100202|"     The purpose of this study is to investigate the efficacy and safety of dietary supplements     (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic     smokers having mild to moderate hyperlipidemia after 30 days of intervention.   "
90601|NCT02100189|"     This clinical trial studies whether esophageal cytology plus fluorescence in situ     hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper     endoscopy for the early detection of esophageal cancer. Genes are the units of     deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that     determine many human characteristics. Certain genes in cancer cells may determine how the     tumor grows or spreads and how it may respond to different drugs. Part of this study is to     test those genes in esophageal cells using FISH.   "
90602|NCT02100176|"     To test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the     progression of the disease in Parkinson's disease (PD) de novo patients, all treated with     Rotigotine, in a randomized controlled study with a 18 months follow-up.   "
90604|NCT02100150|"     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the     treatment of mTBI in adolescents and adults.   "
90605|NCT02100137|"     The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia     diagnosed using a vaginal ultrasound during routine gynecological examination.   "
90606|NCT02100124|"     The purpose of this web-based study is to determine whether reproductive life planning (RLP),     with or without contraceptive action planning (RLP+), will result in reduced risk of     unintended pregnancy when compared to an information-only control group.   "
90608|NCT02100098|"     The purpose of this exploratory study is to characterize the postoperative pain profile of     patients undergoing operation with internal fixation of an ankle fracture under nerve block     anaesthesia. Special attention is payed towards the possible existence and clinical relevance     of a rebound pain phenomenon upon cessation of the nerve block.      Results are used to guide the set up of a randomized controlled trial on the subject.   "
90609|NCT02100085|"     This study is to follow up on the change of immune response by measuring HPV type 16/18 E6     and E7 specific T cell response and lesion condition in subjects who have administered in     DNA-based therapeutic vaccine.   "
90610|NCT02100072|"     The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm     wavelength laser for the treatment of primary hyperhidrosis of the axilla.   "
90611|NCT02100059|"     To determine changes in thigh muscle function and knee pain after a partial meniscectomy     surgery and to also determine the effects of applying electrical stimulation to the knee to     determine if this improves thigh muscle function and decreases pain.   "
90612|NCT02100046|"     Currently, it is established that the voltage-gated calcium channels modulate pain perception     due to an influence on the neuronal transmission and excitability. In the past, attention has     focused on the modulation of high voltage activated calcium channel. More recently,     scientific interest has proven to the low voltage activated calcium channel, also called     T-type channels. The data from the literature show significant involvement of these channels     in the physiology of nociception and pathophysiology of acute and chronic pain. Moreover, in     several animal pain models (acute, neuropathic, inflammatory), T-type channels inhibition     alleviates painful behaviours.      Analgesics treatments available in clinic are ineffective in some patients with chronic pain     (neuropathic, inflammatory) and often induce deleterious side effects. Thus, the clinical use     of selective inhibitors of T-type channels could not only help the development of new     therapies for the treatment of neuropathic pain (prevalence = 5-8 %), but also have a     pharmaco-economic impact due to the low selling price of their inhibitor currently available:     Zarontin®.      The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the     pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a     control group.   "
90613|NCT02100033|"     De-qi as an important factor to therapeutic effect of acupuncture for years, It's a concrete     pathway to approach Qi, an abstract concept in Chinese medicine. However, all previous     physicians and medical scientists have different interpretation to De-qi, and no objective     principles for clinical practice, teaching and studies.      Qi propagated combined with acupuncture practice always be seen as De-qi , therefore, the     study control transmission or not and direction of sensation propagated to compare what's     different in human body. If the change happened as prediction based on acupuncture theories,     it could define De-qi for operation.      The study will collect 60 subjects, from age 20 to 40, the same numbers of male and female.     They will accept different manipulation in left hand HeGu(LI4), and assessed the variations     in microcirculation, temperature of left forearm, and waxing/waning of yin-yang , Qi and     blood in related meridian. We hope to understand if sensation propagated is primary factor of     De-Qi and acupuncture effect .   "
90614|NCT02100020|"     The proposed project will evaluate two methods of implementation of the new Physical Activity     Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities.     The investigators will also determine if following the PAGs will improve aspects of fitness,     function, quality of life and risk for cardiometabolic disease in this population. The     investigators hypothesize that adherence to the PAGs will be higher in people who have been     referred directly to a community-based exercise program, and that this greater adherence to     physical activity will be associated with greater improvements in fitness, function and     quality of life.      This randomized controlled trial will provide important information on how best to implement     physical activity recommendations within the community setting; this information will be     translated to key stakeholders during the final stages of the project.   "
90615|NCT02100007|"     The purpose of this study is to determine the safety and tolerability of ME-344 when given in     combination with Hycamtin® in patients with solid tumors   "
90616|NCT02099994|"     The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate     safety and immunogenicity of vaccines focusing T cell responses on the conserved region of     the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and     Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates     electroporation.   "
90617|NCT02099981|"     Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of     the disease are poorly understood. One of the earliest changes that occur in the retinas of     diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked     increases in blood flow in retinal vessels. The loss of this vascular response may lead to     retinal hypoxia and it has been suggested that hypoxia could be a principal cause of diabetic     retinopathy.      The long-term goals of this project are to determine whether decreased blood flow in diabetic     patients and the resulting retinal hypoxia contributes to the development of diabetic     retinopathy and whether restoration of normal blood flow in diabetic patients slows or     prevents the development of retinopathy.   "
90618|NCT02099968|"     Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated     efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem     to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on     meditation or mindfulness-based interventions have shown positive effects in patients with     hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a     combination of diet, exercise, and stress management, have improved coronary atherosclerosis.     However, no studies have yet investigated the effects of Comprehensive Lifestyle Modification     in patients with metabolic syndrome and/or in combination with fasting therapy.      This study is supported by a grant from the Corona-Foundation, Germany.   "
90699|NCT02098915|"     Infants with gastroschisis typically have poor intestinal motility for the first weeks to     months after birth. Prokinetic agents are often used in these infants to improve intestinal     motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to     support this practice remains weak. Investigators hypothesize that a prokinetic agent given     intravenously (infused into a vein) may be effective in improving gut motility in children     with gastroschisis.   "
90619|NCT02099955|"     Studies have shown that individuals who have suffered a spinal cord injury are at an     increased risk of Vitamin D deficiency compared to able-bodied individuals. It has recently     been shown that Vitamin D deficiency is linked to a large number of diseases and conditions,     including chronic lung disease, vascular problems, and insulin resistance. If this common     nutritional deficiency is proven to be the cause of some of these diseases and conditions in     persons with SCI, then it may easily be remedied with a cheap and effective therapeutic     approach: vitamin D replacement therapy. Because of the high prevalence of vitamin D     deficiency in persons with SCI, this therapy alone or in combination with other treatment     options will be expected to significantly improve overall well being in the SCI population,     decrease hospitalization rate, and the lower the financial burden of care.   "
90620|NCT02099942|"     This registry is designed to monitor the real world clinical performance and safety of the V8     device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or     calculations may be obtained from the imaging or evaluations already performed per the sites'     standard of care   "
90621|NCT02099929|"     Epidemiological studies have shown an inverse association between coffee consumption and risk     of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the     mechanisms are limited.      This project aims to assess the effects of coffee consumption on glucose metabolism, using     stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on     the reduced risk for T2DM.   "
90622|NCT02099916|"     Poor responders to ovarian stimulation represents one of the most frustrating problems in     reproductive medicine. The investigators hypothesize that ovarian response of those patients     could improve by treating these patients with 25 mg DHEA tid for 12 weeks prior to     stimulation.   "
90623|NCT02099903|"     It is a randomized prospective controlled study of transcatheter renal denervation in     patients with systolic heart failure secondary to Chagas' disease. The purpose of the study     is to evaluate the safety and effectiveness of renal denervation in patients with Chagas     heart disease, due to reduction in renal and systemic sympathetic activity.   "
90624|NCT02099890|"     Spinal cord Injury (SCI) is a condition commonly associated with a state of chronic low-grade     inflammation due to a variety of factors such heightened risk for infection and development     of metabolic disorders. Many disorders which have been demonstrated to have an inflammatory     basis have also been found to be at much higher prevalence following SCI. Such conditions     include, but are not limited to, depression, cognitive impairment, neuropathic pain, and     somatic/autonomic nerve function. The fact that such disorders have an inflammatory basis     provides a unique opportunity to treat them with intervention strategies which target the     immune system. Natural anti-inflammatory interventions including a diet consisting of foods     and supplements with anti-inflammatory properties may be an effective option for treating     inflammation in this population. As this treatment strategy will target the inflammatory     basis of many disorders it would be expected to lead to a reduction in pro-inflammatory     mediators thereby leading to more sustainable long-term immune improvements regarding enzyme     function and protein balances. Despite this, surprisingly little research has focused on the     use of anti-inflammatory foods for the treatment of chronic inflammatory conditions, and     effects specific to SCI have been almost completely neglected. As such, the current study     will focus on the daily intake of natural supplements with anti-inflammatory properties over     a 3 month intervention and the effects on inflammation and associated disorders will be     assessed. It is hypothesized that the supplementation will result in positive alterations in     enzyme regulation and protein balances resulting in improvements in each of the outcome     measures of interest.   "
90625|NCT02099877|"     In this prospective observational double-blind study, the investigators aim to assess the     effect of the single nucleotide polymorphism of the μ-opioid receptor gene (OPRM1, p.118A/G)     on the duration of epidural fentanyl labor analgesia.   "
90626|NCT02099864|"     This clinical trial studies genetic and molecular mechanisms in assessing response in     patients with prostate cancer receiving enzalutamide therapy. Androgens can cause the growth     of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of     androgens made by the body. Studying samples of tissue and blood in the laboratory from     patients with prostate cancer may help doctors better understand castration-resistant     prostate cancer. It may also help doctors make improvements in prostate cancer treatment.   "
90627|NCT02099851|"     This is a prospective, observational, multicenter trial to evaluate the safety and     feasibility of selective endovascular unilateral carotid body ablation in patients with     treatment-resistant hypertension. All patients will be followed for two (2) years following     treatment.   "
90628|NCT02099838|"     Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic     patients after treatment with SUs for 5 years, although SUs are widely used in type 2     diabetic patients. This study was designed to evaluate the effectiveness and safety of adding     compound preparation of pioglitazone and metformin for type 2 diabetic patients who have bad     glycemic control with the initial treatment of SUs.   "
90629|NCT02099825|"     The purpose of this research study is to determine whether taking a one-time dose of a     combination of putatively learning-enhancing medications can improve treatment response to a     brief learning-based psychotherapy for public speaking anxiety. The two medications are (1)     d-cycloserine (DCS), a medication that is an agonist (facilitator) of the NMDA glutamatergic     receptor and has been shown in previous studies to facilitate some kinds of learning and     memory; and (2) mifepristone, a medication that blocks cortisol, and in preclinical (animal)     studies has been shown to reverse certain kinds of stress-related learning impairment or     negative learning.      Specifically, the investigators goal is to determine if DCS and mifepristone taken together     augment the learning that occurs during a brief psychotherapy session---a public speaking     exposure exercise. Evidence for this learning effect would be a finding that participants     have reduced anxiety at subsequent public speaking exposures.   "
90826|NCT02097264|"     This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of     action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid     arthritis (RA) and an inadequate response to Methotrexate.   "
90827|NCT02097251|"     Emergency access granted to treat a single patient with advanced Mucopolysaccharidosis Type 7     with UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy via IV     administration every other week (QOW) for up to 144 weeks.   "
90630|NCT02099812|"     Low socioeconomic status (low SES), as defined by educational attainment and income, has been     associated with obesity in industrialized nations. Low SES has been related to impulsive     decision-making characterized by steep devaluation of future outcomes (delay discounting, DD)     and a greater motivation to obtain food (food reinforcement, FR). DD and FR have been shown     to interactively predict ad libitum energy intake in laboratory studies, such that     participants exhibiting high FR as well as high DD consume the most food. Obesity often     results from energy intake in excess of physiologic needs, and thus a plausible mechanism is     that low SES environments increase FR and DD, leading to overeating and obesity. The primary     aims of this study are to determine whether FR and DD interact to predict BMI, and whether     differences in FR and DD mediate the relationship between low SES and obesity, in a large     sample of US adults of varying BMI. In addition, whether high FR and high DD are related to     unhealthy food purchasing and eating behaviors will be assessed. It is anticipated that high     FR and DD will be related to unhealthy food purchasing and eating behaviors.   "
90631|NCT02099799|"     COPD currently afflicts 24 million US residents; the prevalence of COPD is high among     Veterans. Persons with COPD have significant functional disability as a result of the     disease. This project will determine whether a novel Internet-mediated walking program     coupled with a pedometer can improve exercise capacity, improve health-related quality of     life, and decrease the risk of acute exacerbations in persons with COPD. If successful, based     on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise     intervention could help over 8 million persons. The Veterans Health Administration (VHA) has     a strong commitment to providing care to persons with COPD and supporting research directed     at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and     Development includes research in COPD rehabilitation. The proposed research addresses     Rehabilitation R&D Service's current priority area of improving disabled Veterans'     health-related quality of life by reducing disease burden and maximizing functional recovery.   "
90632|NCT02099786|"     This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing     are termed ototoxic. One such drug is the chemotherapy called cisplatin. Currently, if a     patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy     protocols and may be retested only when it is requested by their oncologist and when the     Veteran can arrange an appointment. Researchers think that hearing testing prior to every     treatment of cisplatin may reduce the number of Veterans who get disabling hearing loss from     treatment. The purpose of this study is to compare the current method of monitoring hearing     (audiology clinic protocols termed usual care) with a new portable hearing monitoring     program (a comprehensive program of ototoxicity monitoring termed COMP-VA) that tests     hearing using a portable hearing testing audiometer and a variety of efficient tools and     techniques so that testing can occur prior to each cisplatin treatment at any quiet location     in the hospital.   "
90633|NCT02099773|"     This exploratory and observational study focuses on adults with an intellectual disability     (ID) and their support workers. Two groups of clients are observed: clients using Key Word     Signing, and clients using aided Augmentative and Altenrative Communication (AAC).     Approximately half of adults with ID is estimated to experience communication difficulties.     AAC supports them in their daily communication aiming at optimal participation in society.     Current communication models, such as Participation Model (Beukelman & Mirenda, 2005) and     International Classification of Functioning, Disability and Health (WHO, 2001), regard both     client-related and environmental factors as important elements of communication. A     substantial part of the environmental factors is made up of the communication partners'     characteristics. In daycare and residential services for adults with ID the support worker is     an important communication partner .   "
90634|NCT02099760|"     The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal     samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from     the pharynx is exploratory and will provide new information on the frequency of pharyngeal     infection due to CT and GC.      A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal     and rectal samples using both the Xpert system and AC2 to assess whether women positive for     this pathogen rectally usually or always have vaginal infection due to this pathogen.      The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification     testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting     Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG     will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis     and Neisseria gonorrhoeae in rectal samples.   "
90635|NCT02099747|"     The null hypothesis of no difference in CR% at 3 months between the arms will be tested     against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds     ratio for arm yielded by this model.   "
90636|NCT02099734|"     This study is being done to create a registry to help us learn more about germ cell tumors     (GCT) and other testicular tumors. The registry will include people with these tumors and     also relatives and unrelated people without these tumors. This study will help us learn more     about the prevention, diagnosis, treatment and outcome of these tumors. Studying relatives of     patients and people unrelated to patients with GCT and other testicular tumors will help us     understand why some people get these tumors and why some people don't.   "
90638|NCT02099708|"     The purpose of this study is to investigate the safety and efficacy of long-term     administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical     setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)   "
90639|NCT02099695|"     Treatment of primary hyperhidrosis through a comparative study between oxybutynin     hydrochloride and placebo.      Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of     life.   "
90770|NCT02097992|"     The objectives of the proposed study are to determine 1) the effect of a single dose of     Roflumilast on airway blood flow (Qaw) (study period 1) and 2) the effect of long-term     Roflumilast treatment on airway blood flow reactivity delta Qaw)(study period 2) in patients     with stable COPD who use ICS regularly.   "
90771|NCT02097979|"     OBJECTIVE Our objective was to determine whether two group educational sessions plus     one-on-one eye drop instillation training would improve adherence to glaucoma therapy as     measured by pharmacy claims data in a cohort of newly diagnosed patients. Our hypothesis was     that adherence would be improved in the intervention group and that patients would better     understand their disease and how to manage it.      METHODS Study Design and Population: A randomized controlled clinical trial was conducted in     newly diagnosed glaucoma patients at Maisonneuve-Rosemont Hospital in Montreal, Canada. Half     of the participants were randomized to receive the intervention and half were randomized to     receive a delayed intervention at the conclusion of the study. Inclusion criteria included a     diagnosis of glaucoma requiring intraocular pressure lowering eye drop therapy and     prescription drug insurance through the Régie de l'Assurance Maladie du Québec (RAMQ) (the     Quebec Health Insurance Program) throughout the course of the study. There were three sources     of data for this study: a questionnaire, the medical record, and RAMQ prescription drug     claims data. Follow-up was for one year.      Recruitment and Randomization: From July, 2007 until December, 2011, a researcher approached     eligible patients to determine their interest in participating in the study. Interested     participants signed the informed consent form and were randomized. Participants in the     intervention group were given an appointment to come back to the Hospital for the group     intervention. Participants in the control group were given an appointment to receive the     group intervention at the end of the study.      Intervention: Small groups of about 10 people were gathered for two 60-90 minute educational     sessions on glaucoma in a classroom at Maisonneuve-Rosemont Hospital. During a break, each     patient received one-on-one teaching on how to properly instill drops without touching the     eye or using unnecessary drops.      Questionnaire and Assessment of Eye Drop Technique: A single questionnaire was given at the     end of the study to all participants. The intervention group completed the questionnaire     after the intervention while the control group completed the questionnaire before the     intervention. Questions were included on demographics, systemic comorbidities, ocular     medications, eye drop practices and difficulties, and glaucoma knowledge.      The instructor rated the ability of the participant to put eye drops in the eye taking into     account the number of drops that were used and whether contact with the lid or conjunctiva     occurred (good, fair, bad).      We created a composite score on the perception of the importance of glaucoma eye drop therapy     using the following four questions: 1) do you think glaucoma is a serious disease, 2) do you     believe that your treatment will be effective, 3) do you think your drops can lower the     pressure in your eyes, 4) do you think your drops can help to preserve vision. Answers of no     or do not know were given 0 points and answers of yes were given 1 point. Scores were summed     and the composite score ranged from 0 to 4.      Medical Chart Review: At the end of the follow-up period, information was obtained on: the     prescribed eye drop therapy for each patient per eye, whether the patient had undergone     glaucoma filtering surgery, whether the patient had died or was no longer being followed, the     most recent visual field mean deviation in the better eye using the Humphrey Visual Field     Analyzer 24-2 SITA Standard Program.      Pharmaceutical Claims and Calculation of Medication Possession Ratio: The Medication     Possession Ratio (MPR) was calculated as the sum of days of prescription supply divided by     the number of days in which a prescription was required. Each person gave consent to contact     the RAMQ to obtain pharmaceutical claims for all glaucoma medications. Data were collected on     the date of purchase, and the name, dose, and class of the medicine. Data on the number of     days of medication available per bottle were taken from the Rylander and Friedman studies     with the minimum value used. For the numerator of the MPR, we calculated how many days of     medication were available using RAMQ data. For the denominator of the MPR, we calculated the     number of days that medication was prescribed in the medical chart. We took into account     whether drops were needed for one or two eyes. If a participant was on multiple medications,     we calculated a single mean MPR for all medications. We then dichotomized the MPR so that     those having medication less than 75% of the days were defined as non-adherent, as we did     previously in Djafari et al.      SIGNIFICANCE Adherence can be a problem in glaucoma because patients must often take daily     eye drops despite not noticing any benefit to their vision and despite frequent side effects.     Low cost interventions that help to improve adherence are needed.   "
90868|NCT02096705|"     The purpose is to determine if after 24 weeks of oral daily administration, there will be a     greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with     Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2     diabetes.   "
90641|NCT02099669|"     Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone     marrow function that may progress to acute myeloid leukemia. Many patients become red blood     cell transfusion-dependent. Transfusion dependence is associated with inferior quality of     life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A     commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90 g/L     (normal hemoglobin > 120-130g/L). The question is: would a higher hemoglobin target lead to     improvement in QOL despite the negative impact transfusion dependence may have on QOL (due to     associated time commitments, expense, transfusion reactions etc). Several groups have     prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with     hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of     15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program     has been conducting prospective assessments of QOL since 2007 in all registered and consented     patients using a variety of validated questionnaires. Preliminary analysis (in 236 patients)     revealed that, compared with an age-matched healthy general population, MDS patients have     inferior QOL. Transfusion dependence and anemia were independently predictive of poor     functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level of ≥100     g/L seemed to be the key threshold for improvement in function and symptom scores. The     investigators hypothesize that the target hemoglobins in transfusion dependent MDS patients     are too low and this may account for their inferior quality of life. Our goal is to compare     the effect on QOL of a restrictive strategy (which is the current standard of care), with a     liberal transfusion strategy in a large randomized controlled trial of transfusion dependent     MDS outpatients. Before embarking on such an endeavor, the investigators must first prove     feasibility in a smaller pilot randomized controlled trial.   "
90642|NCT02099656|"     This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate     the effects of lebrikizumab on airway eosinophilic inflammation in participants with     uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second     controller medication. Enrolled participants will undergo a 3-week screening period during     which assessments, including a bronchoscopy procedure, will be made. Participants will     subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection     on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care     therapy throughout the study. End of treatment assessments will be taken at Week 12. Total     study period, including screening and follow-up, is expected to last 23 weeks.   "
90643|NCT02099643|"     Recent data has demonstrated that focal sources are determinant in human atrial fibrillation     (AF) perpetuation.      The investigators sought to identify crucial areas for AF perpetuation during our routine     electrogram (EGM)-based substrate ablation.   "
90644|NCT02099630|"     The study will investigate functional and metabolic changes in the course of antidepressive     treatments.      The investigators will apply different imaging methods to investigate the effects of     antidepressive interventions on resting state neural activity, functional activation during     cognitive and emotional stimulation, neurotransmitter concentrations as well as     concentrations of brain- derived neurotrophic factor.   "
90645|NCT02099617|"     The main objective of the SENIOR study is to establish the efficacy and safety of the     everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with     a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable     angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to     significant coronary artery disease and requiring percutaneous coronary intervention. The     primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated     with a lower rate of the composite rate of major cardiovascular and cerebrovascular events     (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion     revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.   "
90646|NCT02099604|"     The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D     followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with     standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the     sustained virological response (SVR) at 3 months after end of treatment (week 60).   "
90647|NCT02099591|"     To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through     population PK in paediatric patients with opioid induced constipation (OIC).   "
90648|NCT02099578|"     Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that     approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major     modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive     and hypertensive. In addition, the prevalence of hypertension is associated with aging in     both genders; however, the increase in blood pressure (BP) in women after menopause exceeds     that of men.      The development of effective and safe strategies to improve vascular function is of     significance as it can have a great impact on quality of life, productivity and economic     burden for the affected populations. One such alternative would be to introduce into the diet     food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term     goal of the investigators is to provide feasible and effective dietary ways for     postmenopausal women to improve their vascular function and quality of life.      Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks     third among all fruits and vegetables. Hence, the purpose of this study is to bring forth     evidence that incorporation of strawberries into the diet will reduce blood pressure and     improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.      Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85     mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three     groups:        1. 25 g freeze-dried strawberry powder;        2. 50 g freeze-dried strawberry powder; or        3. placebo powder. Participants will be asked to consume the supplements for 8-weeks.          Medical history, medication use, dietary intake, and physical activity will be assessed          at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of cardiovascular          function as well as oxidative stress and inflammation will be measured.      The investigators hypothesize that regular consumption of strawberry will improve     cardiovascular function, decrease BP and blood markers of oxidative stress as well as     inflammation. Investigators also expect the findings of this study to provide a foundation     for further studies to examine the effects of long-term incorporation of strawberry into the     diet and the integrity of cardiovascular system.   "
90649|NCT02099565|"     The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular     and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA     study. In addition, the long-term effects of statins on LDL-cholesterol and different     biomarkers in patients after drug-eluting stents implantation will be assessed. In addition,     such project implementation will allow to clarify the treatment options used by Russian     patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The     information received in this study will help to optimize management of Russian patients with     CAD after PCI in order to improve prognosis and quality of life of these patients.   "
90650|NCT02099552|"     The proposed natural history study will enroll male and female patients, ages 36 months and     younger, who have a diagnosis of XLHED based on genetic testing and who have not received an     investigational study drug. The study protocol will include collection of all relevant     medical history and documentation of clinical outcomes using age-appropriate, minimally     invasive technologies. Data will be collected both retrospectively, back to pregnancy     assessments that may be available, and prospectively through age 5 yrs.   "
90652|NCT02099526|"     The goals of the study are to investigate the needs of older (age 60+) caregivers caring for     adults with cancer at 1-week and 2 weeks following hospital discharge and to explore     strategies that may assist caregivers in their home caregiving needs. This study will explore     how these needs vary based on caregiver spirituality and relationship with the care     recipient.      The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which     are the hematological and non-hematological malignancy units at Duke University Medical     Center (DUMC) respectively. Results of this study will lay the groundwork for creating     tailored interventions for caregivers that are compatible to their preferences and more     responsive to their needs.   "
90653|NCT02099513|"     This study develops and pilots the initial interface of our mobile health platform that will     allow for intra-individual tailoring and personalization of health interventions. This will     allow for just-in-time interventions that adapt both the content and timing, not just     initially, but also over time based upon prior outcome data, responses to an intervention,     current environmental and social context, activity level, location, time, and an individual's     psychophysiological state.1,2      Aim 1: To develop the initial interface of the mobile health platform that will allow     patients to report and receive data representing multiple health domains including blood     pressure, pO2 (pulse oximeter), values, weight, physical activity, calories burned, sleep,     and self-report survey measures such as pain and fatigue.      Aim 2: To assess feasibility of the mobile health platform to receive and deliver data     representing multiple health domains over 1 month through a single-case study design (N=6).3     Aim 3: To develop an algorithm using the diet data collected in Aim 1 that will facilitate     adaptive work by providing patients with automated real time feedback on their progress.      Aim 4: To develop an algorithm using the diet data collected in Aim 1 that will that will     facilitate adaptive approaches by alerting clinicians on the progress of their patients.   "
90654|NCT02099500|"     This is an open-label, non-randomized, multi center, patient sponsored study of     Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who     have critical limb ischemia not amenable for revascularization.      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the disease pathology of patients with     diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived     tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the     adipose tissue specimen. The adipose tissue is then transferred to the laboratory for     separation of the adipose tissue derived stem cells. In addition, peripheral blood will be     collected for isolation of platelet rich plasma, which are then combined with the ASC's for     intramuscular injection into the lower limb.   "
90655|NCT02099487|"     To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide     on survival and quality of life in elderly, poor performance status patients with newly     diagnosed HGG.   "
90656|NCT02099474|"     The purpose of this study is to assess the evolution of raltegravir concentration in the     mother (between the 3rd trimester of pregnancy and one month post-delivery) and her neonate,     when this drug is used to prevent mother-to-child HIV-1 transmission as part of a combined     antiretroviral regimen.   "
90657|NCT02099461|"     To evaluate whether administration of denosumab results in a decrease compared to the control     group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation     index.   "
90658|NCT02099448|"     The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP     using the investigational device C.A 2.0.   "
90659|NCT02099435|"     This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower     gastrointestinal bleeding.   "
90660|NCT02099422|"     Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for     ACS. Efficiency and tolerance évaluation   "
90661|NCT02099409|"     The purpose of this study is to validate current algorithms and evaluate safety and efficacy     of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1     diabetes between 6 - 12 years of age in Luxembourg .   "
90662|NCT02099396|"     The purpose was to evaluate efficacy, safety and effects on survival for lobaplatin and     Gemcitabine in combination with Docetaxel, which can provide a kind of completely new     second-line chemotherapy program for osteosarcoma patients in aggressive-phase, provide     accurate and reliable evidence-based results for clinical applications of lobaplatin in     osteosarcoma patients as one of the third-generation of platinum drugs, and further     consummate and enrich clinical practice guidance on osteosarcoma all over the world.   "
90663|NCT02099383|"     The investigators' preliminary findings suggest that providing patients with acute ischemic     stroke hydration therapy on the basis of their presenting BUN/Cr ratio may help reduce the     occurrence of stroke-in-evolution(SIE) and therefore improve prognosis.      The trial will be carried out in two parts. Part 1 assesses the rate of stroke-in-evolution     72 hours after the onset of stroke as a measure of the activity of BUN/Cr ratio based     hydration therapy. Part 2, The investigators use two outcome measures, including Barthel     index, and modified Rankin scale for neurological evaluation to assess whether BUN/Cr ratio     based hydration therapy results in sustained clinical benefit at three months.   "
90664|NCT02099370|"     The investigators are measuring the adherence rates of an oral MS drug that is to be     administered twice-daily. The investigators would like to observe any patterns that might     indicate factors that greatly affect adherence.   "
90665|NCT02099357|"     The purpose of this study is to determine the effects of creatine monohydrate or vitamin D     supplementation on strength gains following a traditional resistance training program for     adults with spinal cord injury.   "
90666|NCT02099344|"     Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs     better than the other. How long each one lasts until a complication arises or until the graft     is no longer used will be compared.      The study hypothesis is that the Artegraft, being an actual blood vessel, will work better     than the manufactured Propaten graft.   "
90828|NCT02097238|"     This phase II trial studies how well eribulin mesylate works in treating patients with     osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment     (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth     of tumor cells by disrupting the cell cycle.   "
90667|NCT02099331|"     Atrial fibrillation is a common heart rhythm condition that can occur after cardiac surgery     and has been associated with an increase in hospital length of stay, overall hospital costs,     worsening clinical condition and higher rates of death. Newer research indicates that     inflammation is a key contributor to atrial fibrillation in this setting.      Melatonin is a naturally made hormone that is regarded as an extremely effective     anti-inflammatory substance, with a very favorable safety profile. This clinical trial is     being done to test the ability of melatonin to reduce the risk of developing atrial     fibrillation after cardiac surgery.      This is a research study where patients will be given either oral melatonin at 40 mg or     placebo nightly prior to sleep. The study product will start approximately 2 days prior to     the scheduled surgery date and will continue until the 3rd day after the operation. The     remainder of the clinical care will remain the same.      The investigators project that patients who receive melatonin will have a significant     decrease in the occurrence of atrial fibrillation after surgery.   "
90668|NCT02099318|"     Objectives: The objective of this clinical study is to determine if the use of the SRP will     lead to improved effort and time efficiency in cerebral aneurysm surgery. For this     preliminary study, the investigators will assess key time and effort variables associated     with prospectively assessed SRP neurosurgery cases in comparison with cases with no SRP     rehearsal. This is a single site study with one enrolling site. This study will include a     total of 40 cases 20 SRP cases and 20 control cases). SRP and control cases will be randomly     selected according to a predetermined alternating sequence.   "
90669|NCT02099305|"     The primary goal of the proposed research is to assess the effectiveness of the Adolescent     Depression Awareness Program (ADAP), a school-based depression education program, in     increasing depression literacy and treatment seeking in high school students. The ADAP     intervention will be carried out in approximately 60 schools with over 15,000 students. The     following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle     County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.   "
90670|NCT02099292|"     The investigator prospectively evaluated the combination of Rituximab and Dexa-BEAM     (dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by high dose therapy     in patients with relapsed/refractory aggressive and indolent lymphoma.   "
90671|NCT02099279|"     Chronic obstructive lung disease (COPD) is a major cause of morbidity and mortality, and is a     major reason for ICU admission. Cardiac function is often impaired in this disease but its     association with clinical outcome has not been fully established. The study aims to     investigate the association between cardiac dysfunction and clinclial outcomes.   "
90672|NCT02099266|"     By doing this study, researchers hope to learn the following:        -  If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC)          transplant will help to improve the homing process        -  The safety of HBO administration in the setting of the UBC transplant        -  The effects of HBO therapy on the engraftment process   "
90673|NCT02099253|"     Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its     selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent     sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects     .At earlier time It was approved by the FDA only for short-time sedation during mechanical     ventilation of adult patients (<24h) in ICU. Because of its minimal impact on the respiratory     , currently it was more and more widely used to sedate patients undergoing regional     anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age     and gender,such as the drug sensitivity of propofol and remifentanil is increased with     age,while the current study also demonstrated that gender may influence the sedate efficacy     of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to     the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim     to explore the right DEX dose of different Age of patients to produce suitable     sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for     sedation,which is monitored by the BIS,during the operation.The relation between BIS values     and the depth of sedation for patients is also investigated.   "
90674|NCT02099240|"     Based on the current literature, investigators hypothesize that patients with osteomyelitis     who are treated with the standard approach of intravenous antibiotics for the full duration     of therapy will have the same clinical outcomes as patients treated with the experimental     approach of intravenous antibiotics with early switch to oral antibiotics.      The primary objective of this study is to compare patients with osteomyelitis treated with     the standard approach of intravenous antibiotics for the full duration of therapy versus     patients treated with intravenous antibiotics with an early switch to oral antibiotics in     relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy.     Secondary objectives of the study include the evaluation of adverse events related to the use     of antibiotics as well as the cost of care evaluated from the hospital perspective.   "
90675|NCT02099227|"     To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric     skin and soft tissue infections treatment failure rate, as well as emergency department     process outcome.   "
90676|NCT02099214|"     Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible     first for biological disorder in blood iron parameters and minor clinical disorders, before     evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and     congestive heart failure.      The improvement of screening and treatments made those severe affections rare enough not to     evaluate myocardial iron overload a systematic part of the starting check-up. Nonetheless     this myocardial iron overload might have severe implications on cardiac function on a long     term basis.      A single trial was conducted on limited number of patients with 1.5 Tesla MRI, which showed a     myocardial iron overload (defined by a myocardium T2* value <20ms) in 19% of the subjects.      The main objective of this study is to precisely estimate cardiac iron overload in treatment     naive patients with newly diagnosed HFE hereditary haemochromatosis with a 3 Tesla MRI, more     sensitive than the 1.5 Tesla one, in order to later appreciate its correlation with cardiac     morbidity in HHC.   "
90890|NCT02096419|"     The purpose of this study is to determine whether continuous clopidogrel dose adjustment     targeted after platelet function testing improves outcomes during 12 months of follow-up in     acute coronary syndrome patients treated with coronary artery stenting and with determined     high platelet reactivity on clopidogrel.   "
90677|NCT02099201|"     This is a single-center, double-blind, parallel-group, randomized, placebo-controlled,     multiple-ascending oral dose study to investigate the safety, tolerability, pharmacokinetics,     and pharmacodynamics of ACT-389949 in healthy subjects.      Part A of the study will evaluate the safety and tolerability following once a day oral     dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and     pharmacodynamics.      Part B of the study will evaluate the safety and tolerability of ACT-389949 following a     maximum of two different oral dosing regimens: ACT-389949 given either every 3 days for 13     days or every 2 days for 9 days (5 doses for each regimen).      Part C of the study, if required, will provide additional information to that obtained from     Parts A and B in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics of     ACT-389949.   "
90678|NCT02099188|"     Sinonasal tumors are rare diseases, as they account for the 0.2 % - 0.8 % of all tumors. For     patients with inoperable tumors, the prognosis is poor and the current therapy is a     combined-modality treatment that is both more effective and associated with less morbidity.      This study proposes innovative integration of multiple modality of treatment modulated by     histology, molecular profile and response to induction CT.   "
90679|NCT02099175|"     Sinonasal tumors are rare diseases, so no standard treatment for such aggressive tumors has     been reported, given rarity, absence of prospective study and heterogeneity of histologies     and stages of diseases. This study proposes innovative integration of multiple modality of     treatment depending by histology, molecular profile and response to induction CT. Moreover,     such strategies allows the use of latest technology with greater biological effectiveness and     reduction of toxicities.   "
90680|NCT02099162|"     Optical coherence tomography (OCT) has been recently studied for evaluation of coronary     stenting. Because of high resolutions, several reports have shown that OCT is appropriate for     evaluating neointimal tissue after coronary stent implantation. Also, the strut coverage and     the characterization of neointimal tissue can be accurately evaluated. Furthermore,     OCT-defined coverage of a stent strut was proposed to be related with clinical safety in     drug-eluting stents-treated patients. Therefore, we will evaluate the appropriateness of     currently using coronary stents (e.g. Sirolimus eluting stent, Paclitaxel-eluting stent,     Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial     progenitor cell) Capture stent, etc) based on the findings of OCT. Additionally, we will     evaluate neointimal hyperplasia, malposition or strut coverage to decide the differences in     the stent characteristics, the duration of antiplatelet use, and the differences according to     the clinical presentations.   "
90681|NCT02099149|"     Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and     their infants who develop disease versus those who do not. Use this comparison to establish     antibody levels associated with reductions in risk of GBS disease in infants aged less than     90 days.   "
90682|NCT02099136|"     This randomized clinical trial studies if celecoxib will prevent the damaging effects of     sunburn in healthy volunteers. Exposure to ultraviolet light can induce erythema, sunburn or     skin redness caused by inflammation. Celecoxib may reduce skin damage by blocking enzymes     associated with sunburn in healthy volunteers. Studying samples of skin in the laboratory     from patients receiving ultraviolet-radiation before and after celecoxib treatment may help     doctors learn more about the effects celecoxib has on cells.   "
90683|NCT02099123|"     The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with     placebo will prolong overall survival or disability free survival amongst healthy elderly     people (≥70 years).   "
90684|NCT02099110|"     This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin     given together or alone along with metformin in participants with type 2 diabetes mellitus     (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of     this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater     hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.   "
90685|NCT02099097|"     The purpose of this study is to develop and test a web-based game called Quit It that is     designed to help smokers who have quit smoking cope with any smoking urges they may have. The     purpose of the game is to help people quit and stop people from smoking again.   "
90686|NCT02099084|"     This research study was done to see what the effects are of Teduglutide on people with short     bowel syndrome (SBS). Teduglutide is a synthetic medication administered as an injection,     which has shown to increase intestinal blood flow, inhibit gastric secretion, increase growth     of intestinal cells and increase absorption of nutrients. Teduglutide has demonstrated to     decrease Total Parenteral Nutrition (TPN) requirements by 20%. Teduglutide is approved by the     Food and Drug Administration (FDA) for the treatment of adult patients with Short Bowel     Syndrome (SBS) who are dependent on parenteral support.      The primary hypotheses for this study were 1) that Teduglutide significantly increases the     gastric emptying half time of solids when compared to placebo. 2) Teduglutide will     significantly decrease the intestinal permeability and urinary excretion of lactulose when     compared to placebo.   "
90687|NCT02099071|"     This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending     single oral dose and food interaction Phase 1 study. It will evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of     ACT-389949 in healthy male subjects. It will also investigate the effect of food on the     pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.   "
90688|NCT02099058|"     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and     preliminary efficacy of ABBV-399 in subjects with advanced solid tumors.   "
90700|NCT02098902|"     The purpose of this study is to test the effect of a novel six-month behavioral program to     reduce sugar-sweetened beverage consumption among preschoolers and their mothers. The     behavioral intervention tested will be delivered via a mobile-based website, text messages     and email in addition to one face-to-face group meeting. The intervention will be compared to     a waitlist control group. Participants will be 42 overweight/obese mothers and their children     ages 3-5 living in the Chapel Hill/Raleigh/Durham area. Sugar-sweetened beverage consumption     and weight in both children and mothers will be measured at three- and six-months     post-randomization. It is hypothesized that children randomized to the intervention will have     a greater reduction in sugar-sweetened beverage consumption at 6 months compared to children     randomized to the control group.   "
90689|NCT02099045|"     Background: It is well known that emergency physicians can conduct ultrasound examinations as     a supplement to initial physical examination. No previous studies have been conducted to     evaluate the total findings with ultrasound on a broad unselected group of patients in the     Emergency Department.      Aim: We aim to identify the pathology found in an unselected cohort of patients in a Rural     Emergency Department. Secondarily we aim to quantify the changes done in treatment as a     result of the ultrasound examination performed bedside in the Emergency Department.      Hypothesis: Supplemental ultrasonographical examination will change diagnostics and treatment     in 10 % of an unselected cohort of patients in the Emergency Department.      Method: We will perform a structured ultrasound examination of 406 patients on an unselected     cohort in the emergency department. All patients age 18 years and above presenting in the     emergency department will be included in the study. Patients unwilling to give informed     consent will be excluded from the study. Patients will be excluded if the ultrasonographic     examination cannot be performed within the first two hours after initial contact with the     treating physician. The study will be conducted in two substudies. Sub study 1 including all     patient legally competent to give informed consent. Sub study 2 including all legally     incompetent patients who cannot give informed consent due to acute illness. These patients     will be included in the study under the rules of emergency research.      After including the patients we will ask the treating physician a series of binary questions     regarding diagnosis and treatment plan.      Outcome: Primary outcome is the pathology found by ultrasound in the department. Secondary     outcome will be the changes in diagnosis or treatment plan. Pathology and changes in     diagnosis/treatment will be stratified according to initial complaint, triage level, age and     other factors. This has never been done on unselected patients in the Emergency Department.      Ethical considerations and adverse effects: Ultrasound transmits high frequency waves into     the tissue, which is reflected to the ultrasound probe. The time and magnitude of the     returning sound waves are interpreted into picture on the screen. No adverse effects have     been reported on the basis of the sound waves transmitted through the tissue.      Some patients might experience discomfort due to the sticky sensation from the application of     ultrasound gel. Others might experience discomfort from the pressure applied to the probe     under the imaging. Adverse effects, which we are not aware of, may exist. However, clinical     ultrasound has existed since the 1950'ies and new adverse effects are unlikely.      Publication: All results will be published in international peer-review journals. Also in the     event of inconclusive results.   "
90690|NCT02099032|"     Polar lipids have a specific chemical structure: they are an essential component of human     cell membranes, play a major role in the nervous system and also influence the metabolic     pathways including the cholesterol metabolism.      Polar lipids are used in food-processing industry for their emulsification properties. The     most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers     such as polar lipids.      The purpose of this research is to study plasma cholesterol variation after daily intake of     milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of     cheese product during four weeks instead of their usual cheese products.      It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine     Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).   "
90691|NCT02099019|"     As the prospective, observational, cross-sectional study, the accuracy of CT     angiography-based therapeutic decision-making for revascularization will be evaluated. The     primary objective of this study is to evaluate the accuracy of CT angiography-based     therapeutic decision-making for revascularization prior to conventional angiography whether     CT angiography is an accurate non-invasive technique to determine the most appropriate     therapeutic strategies.   "
90692|NCT02099006|"     This study is testing drugs not previously used topically for the treatment of vulvodynia, a     common genital pain syndrome. It is hoped that one of these drugs will improve vaginal     entryway pain with touch, daily pain scores and sexual functioning.   "
90693|NCT02098993|"     The purpose of this study is to determine the feasibility of performing a larger multicenter     phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest syndrome     (ACS). Prespecified feasibility criteria consists of the ability to enroll potential study     participants, which includes the timely notification of hospitalized patients with ACS, the     capacity to consent eligible individuals, and the ability to appropriately randomize eligible     patients within 24 hours of diagnosis. Additional feasibility objectives involve ensuring     appropriate eligibility criteria, proper administration of the study drug, and the ability to     completely and accurately collect clinical data of interest. The final aim of our pilot study     is to provide preliminary data, with respect to treatment effect and variance, to allow     sample size calculation in a larger trial given the lack of data available to help guide this     process. The investigators hypothesize that the use of UFH in ACS will result in a decrease     in the duration of hospitalization and improve other clinical outcomes, such as the duration     of hypoxemia and duration of moderate to severe pain.   "
90694|NCT02098980|"     There is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum     levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose     tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is     that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will     decrease insulin resistance and the associated metabolic indices linked to the later     development of T2DM.   "
90695|NCT02098967|"     This open label, Phase I study of RO6839921 is a dose-escalation study with two arms. Prior     to investigations in either arm, patients in a single cohort, Cohort 0, will receive     non-escalating, intravenous (IV) doses of RO6839921 daily on Days 1-5 of a 28-day cycle.     Interim PK and safety data from this cohort will be evaluated before initiating     dose-escalation.      In arm A, RO6839921 will be given to patients with advanced solid tumor malignancies. In Arm     B, RO6839921 will be given to patients with relapsed/refractory acute myeloid leukemia (AML).     The arms will escalate independently. Escalation will begin in solid tumor patients (Arm A)     in single patient cohorts, using a new Continual Reassessment Method (n-CRM). Escalation for     AML patients will be initiated at or below the dose level that causes >/= Grade 2 hematologic     side effects in Arm A. Escalation in AML patients will follow a rolling 6 design.      In both arms, RO6839921 will be administered by IV infusion on Days 1-5 of 28-day cycles.      There will be no intrapatient dose escalation. All patients may be treated until disease     progression/relapse or unacceptable toxicity.   "
90696|NCT02098954|"     Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of     non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or     secondary resistance will be developed after TKI treatment, doctors do plenty of researches     to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with     chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive     mutations, several study shows that sensitive mutations still exist after TKI resistance,     because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents     for met amplification(such as Crizotinib) are so expensive that many Chinese patients could     not support. Thus, the investigators hypothesis that, after first line TKI treatment, the     patients who developed TKI resistance could still benefit from second line TKI combined with     chemotherapy.   "
90697|NCT02098941|"     The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam     and oxcarbazepine in a long term epilepsy treatment.   "
90869|NCT02096692|"     The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD     System when used under specific MRI conditions.   "
90701|NCT02098889|"     Although Hyoscine N butyl bromide (HBB) is used liberally to facilitate cervical dilatation,     there is little and inconclusive data about its efficacy. The aim of this study was to     determine the efficacy and safety of HBB on the augmentation of labor.420 of total 1640     pregnant women admitted to the investigators clinic (Sisli Ethal Training and Research     Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 37-41 gestational     weeks, active phase (cervical dilatation: 4 cm, cervical effacement: %50 or more) of     spontaneous labor with vertex presentation enrolled to study. 382 of them were included in     this study. Patients were randomized to receive intravenously(IV) either 20 mg/ml HBB or a     similar amount of placebo (1 ml 0.9% NaCl) at the beginning of the active phase of labor. The     medications applied as single dose. The time elapsed until the second stage of labor, second     stage and third stage were measured.   "
90702|NCT02098876|"     Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction     and restore blood flow to the heart muscle. Stents could also be coated with a drug     (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue     within the vessel that otherwise could lead to re-narrowing. This study will evaluate the     effects of 2 FDA-approved metallic stents with different designs that may have important     effects on regional plaque response and blood flow dynamics immediately after stent     deployment and stent healing at 12 months follow up.   "
90703|NCT02098863|"     Despite the important work of previous sickle cell disease (SCD) cohort studies, there remain     many understudied areas that require investigation. An important knowledge deficit is the     slow but progressive process of chronic end-organ dysfunction. The majority of organ     dysfunction becomes apparent in the young adult years, but comprehensive assessment of adults     and understanding of predictors of adulthood organ dysfunction are insufficient. Similarly,     the role of disease-modifying therapies, such as hydroxyurea, in preventing organ dysfunction     later in life is not clear. Extended follow-up of patients through the transition into     adulthood is imperative to understand the long-term implications of pediatric sickle cell     care.      This observational study will collect data in a systematic fashion at participants' regular     clinic visits to answer the objectives described below.      In addition to primary study objectives, SCCRIP participants will be eligible to participate     in a sub-study, which will investigate genetically determined responses to Hydroxyurea (HU)     via a pharmacokinetic study (PK). This one time study will involve blood collection at timed     intervals proceeding a dose of HU. Defining the basis for this inter-individual variability     will allow the identification of poor HU responders prior to initiation of therapy and the     seeking of alternative treatments which seek to optimize disease treatment by accounting for     individual variability in genes, environment, and lifestyle.   "
90704|NCT02098850|"     The purpose of this evaluation is to record the management and outcome of adults with     S.aureus bacteraemia (SAB) across multiple European, Asian and North American sites and to     identify key quality indicators associated with improved outcome.   "
90705|NCT02098837|"     The purpose of the study is to investigate the benefits of switching away from a kind of drug     called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients'     cardiovascular health (the health of their hearts). Patients are currently taking two other     anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their     boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the     boosted PI and dolutegravir more accurately, half of study participants will be switched to     dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on     the boosted PI.      Boosted PIs are associated with increased heart and circulation risk so it is hoped that     switching from a boosted PI to dolutegravir will improve the health of the patients' hearts.     Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in     the US and Europe. Clinical trials using dolutegravir have found that it is effective at     suppressing the HIV virus, and it is at least as effective as the other drugs.      This study will also investigate the safety (in terms of other side effects and the routine     blood tests which the investigators ordinarily use to monitor patients' treatment) and     monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment     from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in     their blood, and CD4 count is a measure of a type of cell that is in their immune system. We     also aim to improve patients' cardiovascular health in general by providing them with     information on how to live a healthy lifestyle (eg improving their diet, stopping smoking     etc).   "
90706|NCT02098824|"     Single center threeway double blind cross over trial investigating the pharmacological     responsivity in patients with VCI using a challenge aimed at the monoaminergic and     cholinergic neuronal systems   "
90707|NCT02098811|"     The purpose of this study is to evaluate and compare the safety and efficacy of a     non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue     and skin tightening.   "
90708|NCT02098798|"     We propose a randomized controlled study to determine the detection rates of neoplasia with     high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High     definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from     diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or     UC.      We hypothesized that these novel endoscopic techniques using High definition colonoscopy with     virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone     and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in     patients with long standing IBD.      We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense     and considerable time.      In addition, we can hope to produce evidence and inform the way in which we perform     surveillance colonoscopy especially without large number of multiple random biopsies but only     few targeted smart and intelligent biopsies using high definition colonoscopy with iSCAN     technique as is already the European practice in several centres.   "
90763|NCT02098083|"     Data collection for this study will be done by clinicians working in inpatient rehabilitation     units with persons with acute stroke. No interventions are included in this study. It is     designed to capture trends in current clinical practice for persons with stroke. This data     will be useful in identifying the most beneficial and effective walking treatments as well as     most significant patient characteristics that impact recovery for persons acutely after     stroke. All data collection will take place during the inpatient rehabilitation stay.   "
90709|NCT02098785|"     Worldwide, liver related morbidity and mortality continue to rise. It is the 5th commonest     cause of death in the UK. Liver damage consists of two main components - a) damage to the     cells of the liver, called hepatocytes, meaning the liver cannot function properly leading to     jaundice (yellow appearance of the skin and/or eyes) and liver failure and b) scarring of the     liver, called Cirrhosis, leading to impaired function and inadequate blood flow through the     liver with potential to develop into cancer. Manifestations of this state include ascites     (fluid in the tummy) and varices (swollen blood vessels in the food pipe). Liver transplant     is currently the only curative treatment for end stage chronic liver disease. Unfortunately     its high demand has not been matched by an equivalent rise in liver donations and even when a     transplant has occurred there are numerous lifestyle effects such as immunosuppression and     kidney impairment thus outcome remains poor for many patients. Coffee has been shown to have     mortality benefit in humans and drinking two to three cups a day was associated with a 40%     reduced risk of developing cirrhosis, particularly alcohol related; and higher the more cups     consumed. Previous work has demonstrated coffee reduces the level of fibrosis in the liver by     interrupting signalling pathways, blocking the effects of special products, called cytokines,     and reducing accumulation of iron. The investigators' hypothesis is that given the potential     for caffeine to be used as a treatment in SSAO activity associated diseases it is important     to see if the activity of SSAO can be blocked in healthy humans too. The Investigators' aim     to examine the effect of caffeine on circulating VAP-1 levels in large numbers of healthy     volunteers to assess its potential as an attractive therapeutic target in view of its low     toxicity and widespread availability.   "
90710|NCT02098772|"     The objective of this investigation is to compare the cardioprotective effects and safety of     two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients     undergoing aortic valve surgery. The study design is a prospective, double blind,     multicenter, randomized, Phase III comparison study intended to demonstrate superiority in     surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24     hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement     (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively     (e.g., myocardial infarction).   "
90711|NCT02098759|"     The primary objective of clinical part of EPISTOP project is to identify the clinical and     molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC.      Secondary objective of the clinical part of EPISTOP is to compare the effects of standard     antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs     after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.   "
90712|NCT02098746|"     The purpose of this study is to evaluate the safety and efficacy of long-term use of     pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with     type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy     (pioglitazone at 15 mg/day) in the routine clinical setting.   "
90713|NCT02098733|"     The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias     Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical     setting.   "
90714|NCT02098720|"     This study is designed to evaluate the effect of Conbercept therapy on visual acuity and     anatomic outcomes and safety observed in subjects with very low vision secondary to wet     age-related macular degeneration.   "
90715|NCT02098707|"     Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide     significant improvements in postural instability in Parkinson's disease, whereas previous     reports of physical interventions have suggested promising results. The investigators want to     study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on     balance disorders in Parkinson Disease (PD).   "
90716|NCT02098694|"     The purpose of this study is to determine whether patients with spondyloarthritis are more     satisfied with a physiotherapy-led outpatient clinic than usual care and whether there is a     difference between patients in a physiotherapy-led outpatient clinic and those in usual care     regarding disease activity, function and mobility.   "
90717|NCT02098681|"     Context: Chest wall deformities in children are relatively common. One such deformity, known     as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these     abnormalities - present in approximately 1 out of every 400-1000 births. This deformity is     often a cosmetic problem for affected individuals. When severe, PE can also be associated     with cardiopulmonary compromise.      Treatment of PE involves surgical correction. There are several potential methods for     correcting PE. In the past the most common repair involved an open procedure which involves     excision and reshaping of the ribcage. More recently a minimally invasive procedure has been     adopted involving the placement of a stainless steel or titanium bar underneath the sternum     to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries with     it significant post-operative pain management problems. In fact, the pain issues after Nuss     procedure may be more significant than after open repair. The quality of postoperative pain     control in these cases has been shown to affect several measurable objective outcomes during     hospitalization including capacity for deep breathing, early mobilization, ambulation, and     length of hospital stay.      Epidural analgesia (EA) has been one of the standard methods for managing pain in the early     postoperative period after PE repair. Unfortunately severe pain may persist after the removal     of an epidural catheter resulting in a difficult transition period just prior to discharge     from the hospital. In addition reports of neurological injury after epidural analgesia for     Nuss procedures have appeared. In light of these issues, many institutions have opted for     alternative methods of pain control including peripheral nerve blocks, patient controlled     analgesia, and wound catheters.      There remains significant debate as to which pain control methodology is best. There is     little consistent data available on pain control or outcomes that occur after EA is stopped.     Moreover there is reluctance in any one institution to trial or randomize patients to a     variety of treatment modalities. For all of these reasons, investigators are proposing     participation in a multi-institutional data sharing project concerning the repair of EA in     which participating centers will collaborate to better understand the outcomes of     perioperative care for patients undergoing correction of this problem.   "
90718|NCT02098668|"     Development of a bio-mathematical model of the human female cycle   "
90719|NCT02098655|"     Objective: To analyze different parameters in patients with Parkinson's Disease (PD) obtained     through the use of a stabilometric platform and compare them with those of a control     population. To interpret the data in order to find some postural instability indicators that     can become useful to build a rehabilitation strategy for balance disorders in PD.   "
90720|NCT02098642|"     Parkinson's disease is a degenerative disorder of the central nervous system. The motor     symptoms of Parkinson's disease result from the death of dopamine-generating cells in the     substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in     the course of the disease, the most obvious symptoms are movement-related; these include     shaking, rigidity, slowness of movement and difficulty with walking and gait. A     multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different     parameters in PD that are poorly responsive to dopaminergic therapy. In this study, we aim to     understand whether the passive mobilization of the metatarsophalangeal joint of the hallux     determines an increase in the joint range in this district, allowing to improve, at least,     the gait.   "
90870|NCT02096679|"     Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in     healthy male volunteers   "
90721|NCT02098629|"     Heart attack is the leading cause of death in the developed world. Following heart attack,     re-establishing blood flow in a clogged heart vessel using percutaneous coronary intervention     (PCI) is the standard of care. This therapy is called reperfusion therapy. Unfortunately,     reperfusion therapy itself poses additional heart muscle damaging effect, a process called     reperfusion injury. Excessive reperfusion injury can offset the net benefit of heart vessel     blood flow restoration in patients with heart attacks. For those heart attack survivors,     massive reperfusion injury can contribute to heart failure which carries high risk for death     and long-term disabilities. To date, there is no drug available that can reduce reperfusion     injury in heart attack patients.      Our group has demonstrated in a preclinical study that combining two available medications     (milrinone and esmolol) when given right before the onset of reperfusion therapy greatly     reduces heart muscle damage in an animal heart attack model. Furthermore, in a clinical     safety, we demonstrated that combination therapy with milrinone and esmolol is safe in     patients with heart attack undergoing PCI. If the heart-protective effect observed in our     preclinical study can be replicated in human subjects, this proposed therapy will become the     first of this kind to treat clinical reperfusion injury.      The present trial is a proof-of-concept study to determine whether the combination     administration of milrinone and esmolol at the onset of reperfusion reduces the heart muscle     damage in heart attack patients who receive reperfusion therapy with PCI.   "
90722|NCT02098616|"     The purpose of this study is to determine whether treatment with     Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is     feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.   "
90723|NCT02098603|"     More than 530,000 individuals work as US Correctional Officers (COs) responsible for     overseeing the approximately 1.6 million offenders who are incarcerated at any given time in     the United States. Prison work is regarded as one of the most difficult occupations with CO's     having one of the highest nonfatal injury rates of all U.S. occupations. The few studies done     on CO's show high levels of stress, cardiovascular disease, high job burnout, increased sick     leave rates and absenteeism, and decreased quality of life leading to premature     illness/injury and high employer healthcare costs. Many of these conditions could be     prevented by specific training activities and healthier lifestyles. The investigators wish to     test a worksite-based, health promotion curriculum in COs with the overall hypothesis that     the program will improve health and decrease injuries. The program proposed would be the     first occupational intervention to improve the safety, and emotional and physical health of     those who are charged with the complex task of prison work protecting the investigators     communities. If successful, this proposal would result in an exportable, practical     occupational safety and health program applicable for use by local, state, and federal     correctional facilities.   "
90724|NCT02098590|"     Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious     diseases. With approximately 627.000 deaths a year, it is both a chief cause of morbidity and     mortality as well as a significant contribution to ongoing poverty in endemic countries.     Ultimately, the key to malaria control, and hopefully eradication, would be an effective     vaccine. Though a number of vaccine-candidates have entered the pipeline of pre-clinical and     clinical development, they have yet to achieve the level of efficacy necessary for effective     malaria prevention. It has been shown previously that if healthy human volunteers taking     chloroquine chemoprophylaxis are repeatedly exposed to Plasmodium parasites through the bites     of infected mosquitoes, they are fully protected against a later challenge infection with a     'homologous' (genetically similar) Plasmodium parasite. This process is known as     ChemoProphylaxis and Sporozoites, or CPS-immunization. One of the obstacles to developing an     effective vaccine is the genetic heterogeneity of malaria parasites. To further consider the     development of whole-parasite based vaccines against malaria and in order to better     understand the protective immunity induced by CPS-immunization, it is essential to     investigate whether heterologous protection against genetically diverse (heterologous) P.     falciparum clones can be induced.      This is a single center, randomized, double-blind study to determine whether healthy     volunteers immunized with P. falciparum NF54 parasites under chloroquine prophylaxis are     protected against a challenge infection with the genetically distinct NF135.C10 or NF166.C8     P. falciparum clones.   "
90725|NCT02098577|"     The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian     patients and compare this results with the results of a control group of patients treated     with a stabilometric platform.   "
90726|NCT02098564|"     Background Patients with the same type of hand injury often reach different functional     levels. Therefore, it is necessary to investigate what kind of rehabilitation is most     efficient for each individual patient.      Research has shown that a person's Sense of Coherence (SOC) affects how he /she deals with     disease. Furthermore, SOC can help predict final outcomes after orthopedic injuries and     should therefore; be taken into consideration when planning rehabilitation. It was concluded     in a study that patients with a weak SOC who have had a hand injury, may benefit from extra     support to manage their everyday activities in order to reach the same final outcome as     patients with a strong SOC.      Purpose To investigate two types of rehabilitation on patients with a hand-related injury     (joint mobility exercises vs. activity-based training and joint mobility exercises) and to     investigate whether SOC can be used as an indicator of which patients would benefit from     activity-based training.      Hypotheses        1. Patients with a hand-related injury will benefit from activity-based training in their          rehabilitation program.        2. Patients with a weak SOC will achieve the best functional level, if activity-based          training is included in their rehabilitation program.        3. Patients with a strong SOC will not achieve a higher functional level, if activity-based          training is included in their rehabilitation program.      Study design Randomised control trial. Methods Four-hundred-twenty- patients age 18 years or     older are included when referred to specialized outpatient occupational therapy after a     hand-related injury. To ensure sufficient and balanced patient variation in relation to     pre-rehabilitation sense of coherence, a balanced randomisation principle has been     implemented.      Data will be collected through questionnaires. The questionnaires measure SOC (13 items     version), function (DASH), quality of life (EQ5D) and satisfaction.      All participants will perform joint mobility exercises which are appropriate for their     injury. In addition, participants who will be performing activity-based training will train     with specific meaningful activities which they performed prior to the hand-related injury.      Clinical relevance The knowledge obtained will be incorporated into the planning of     occupational therapy rehabilitation services for this patient group, so that the patients     will receive the most optimal conditions in which to achieve their previous level of function     after a hand injury.   "
90727|NCT02098551|"     Aim of this study is to use the major allergen 1 of birch-tree pollen (Bet v 1, Betula     verrucosa, synonymous Betula pendula), to investigate the contribution of immunoglobulin E     (IgE)- versus non-IgE-mediated mechanisms to chronic skin inflammation in atopic dermatitis     patients.   "
90764|NCT02098070|"     The focus of the study is to determine the prevalence and variance of self-reported knee pain     characteristics in a community-derived sample of adults aged 40 years and over. It will also     identify characteristics such as structural changes of osteoarthritis of the knee as well as     physiological parameters and blood and urine biomarkers.   "
90728|NCT02098538|"     Regorafenib is an oral medication that can interfere with cancer cell growth and reduce the     growth of blood vessels around tumors. This study will help find out if regorafenib is a     useful drug for treating patients with adenoid cystic carcinomas. Regorafenib has been     approved by the Food and Drug Administration (FDA) for use in other cancers, but remains an     experimental drug that has not yet been approved for use in adenoid cystic carcinoma.      In this study, the patient will initially be treated with a dose of regorafenib that is lower     than what the FDA approved for other cancers in an attempt to decrease the risk of side     effects. It is possible that this lower starting dose may not be as effective as the higher     FDA approved dose. If the patient does well with the lower dose for at least a month on     treatment, the physician may consider increasing the dose to the FDA approved dose.   "
90729|NCT02098525|"     Cryptococcal meningitis is one of the most common central nervous system infections among     HIV-infected patients. The outcome is generally severe. This study aims to determine     long-term survival rate among HIV-infected CM patients in the era of antiretroviral therapy     (ART). The secondary objectives are to clarify outcomes of CM and determine prognostic     factors.   "
90730|NCT02098512|"     Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard     of care reduced intensity regimen and an allogeneic stem cell transplant (from another     person, related or unrelated). Following recovery, patients will receive a medication called     Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this     treatment will be safe and well tolerated in children and young adults.   "
90731|NCT02098499|"     Haloperidol is known to be a safe alternative medication to control difficult pain, and has     been shown effective when compared to placebo for controlling headaches. Investigators     hypothesized that the combination of haloperidol and diphenhydramine would be a useful     medication choice for migraine headache patients in the emergency department in comparison to     a common migraine treatment regimen of metoclopramide and diphenhydramine.   "
90732|NCT02098486|"     Background and aims: The use of prophylactic antibiotics before endoscopic retrograde     cholangiopancreatography (ERCP) is recommended by all major international gastroenterological     societies, especially in the presence of an obstructed biliary system. Their use is intended     to decrease or eliminate the incidence of complications following the procedure, namely     cholangitis, cholecystitis, septicemia, and pancreatitis. However, there were a few reports     concerning the dosage, duration and adopting antibiotics most suitable for this purpose. The     aim of this prospective comparative study is to compare the occurrence rate of     post-procedural complications, such as cholangitis, bacteremia and septicemia between     intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with bile duct     obstruction who will undergo therapeutic ERCP procedure.      Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample     Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones,     benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous     moxifloxacin and ceftriaxone group, respectively (using simple randomization program).     Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day,     diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes     before ERCP procedure, and will be given to a patient for more than 3 days if the patient     develops symptoms and signs of cholangitis or septicemia.   "
90733|NCT02098473|"     The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment     of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of     double-blind treatment and 52 weeks of open-label extension.   "
90734|NCT02098460|"     To evaluate the effect of concomitant administration of Probucol and Cilostazol (based on     Atorvastatin treatment) on the atherosclerosis related markers (including the thickness of     the Achilles tendon) in severe hypercholesterolemia subject, through the observation of the     thickness of the Achilles tendon, the thickness of mean carotid intima-media, anti-oxidation     biomarkers and serum lipid profile.   "
90735|NCT02098447|"     The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous     system stimulation on vital parameters of wound healing in diabetics. It is investigated if     auricular vagal nerve stimulation has an effect on heart rate variability as well as     peripheral local blood perfusion, and if this effect depends on the health status of the     study participants (diseased/healthy).   "
90736|NCT02098434|"     The study is investigating the impact of progesterone and estrogen on brain areas that are     involved with stress response and drug craving. The study will involve 40 women who will     participate in the Montreal Imaging Stress Task (MIST) while undergoing fMRI scanning     procedures. Half of the women will complete the procedures during the luteal phase of the     menstrual cycle; the other half will complete procedures during the follicular phase.     Subjective and physiological measures (cortisol levels) will be used to measure stress and     craving response. Hypothesis 1A is that all women will exhibit increased craving, stress     response, salivary cortisol and BNST and limbic nuclei activation in response to the MIST     task. Hypothesis 1B is that these increased responses will be higher for women in the luteal     phase than for women in the follicular phase of the menstrual cycle.   "
90737|NCT02098421|"     This study is considering current standard oxytocin dosing regimen in combination with Foley     bulb for cervical ripening is associated with improved outcomes including greater percentage     of women delivered within or less than 24 hours. The investigators will also assess other     maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding,     uterine atony, cesarean delivery and use of regional analgesia.      Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or     no oxytocin while the Foley bulb is in place. As part of standard of care for inductions,     Foley bulbs will be placed for all participants. Study participants who are randomly assigned     to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study     participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb     is removed.      After delivery, information will be collected from participant's chart on the outcome of     pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean     section), and baby's outcome (such as birth weight, APGAR scores, and any complications).   "
90765|NCT02098057|"     The overall hypothesis of this research study is that gluten intake alters intestinal barrier     function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac     gluten sensitivity (NCGS).   "
90738|NCT02098408|"     Cognitive deficits are known to be a core feature of schizophrenia and seem to become     manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits     are known to pose a critical barrier to functional recovery. Hence it is of vital importance     to find intervention strategies that can alleviate these cognitive deficits and consequently     improve daily functioning, and quality of life, as well as the prognosis for UHR-patients.     The investigators will examine whether:        -  Cognitive remediation therapy will be superior to standard treatment in improving          cognitive functioning in UHR- patients (null hypothesis: No difference between the two          groups).        -  Cognitive remediation therapy will be superior to standard treatment in improving          psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No          difference between the two groups).   "
90739|NCT02098395|"     This trial is conducted in Africa, Europe and North America. The purpose of the trial is to     investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1     diabetes.   "
90740|NCT02098382|"     Non-interventional prospective data collection designed to evaluate clinical outcome on the     efficacy of the use of Dilapan-S in the indication of labor pre-induction in women     with/without a history of Caesarean section. The evaluation will be based on prospective data     collection in at least four obstetrics centers in the Czech Republic.   "
90741|NCT02098369|"     About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using     O2 can prolong life and increase quality of life. Patients often do not use their oxygen as     prescribed, which means that they are not benefiting as much as they could be from this     therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients     and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and     improve health in patients with chronic obstructive pulmonary disease (COPD).   "
90742|NCT02098356|"     This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis     bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base     changes and overall control of metabolic acidosis with the 2 treatment regimens. These     parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as     part of usual care. They will then be switched to a lower bicarbonate prescription, after     which these parameters will be reassessed. The study will also examine changes in     inflammatory markers, glycemic control, ketogenesis, and lipolysis.   "
90744|NCT02098330|"     The purpose of this study was to compare the treatment effectiveness of steroid therapy for     vestibular neuritis by using video head impulse test.   "
90745|NCT02098317|"     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly     becoming the one of most common causes of chronic liver disease in children. The pathogenesis     of NAFLD is generally considered the result of a series of liver injuries, commonly referred     as multi-hit hypothesis. Several studies suggest that inflammatory pathways and oxidative     stress could be responsible of disease progression.      The purpose of this interventional study is to evaluate the efficacy and tolerability of     docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven     nonalcoholic fatty liver disease (NAFLD).   "
90746|NCT02098304|"     This is a prospective, multi-centre, post-approval clinical study to assess the safety and     the performance of the Calcivis Caries Activity Imaging System in aiding the identification     of active caries lesions on the occlusal surfaces of human teeth. Following the     identification of potential caries lesions by oral examination under ICDAS (International     Caries Detection and Assessment System) guidelines, a disclosing solution will be applied     which will cause areas of active demineralization (loss of calcium ions) to luminesce - these     will be captured with an intra-oral camera to produce mapping images of the tooth surface.     For the purposes of this study the presence / absence of luminescence will be used as an     indicator of lesion activity / inactivity.      The study will be deemed a success if the level of agreement between elevated luminescence     with the Calcivis System, and areas of expected lesion activity as rated by the Investigators     ICDAS staging, is above 70%, is not due to chance and correlates well with published data on     active non-cavitated lesions in molars at various stages of eruption.   "
90747|NCT02098291|"     This study was designed to determine the effect of jaundice on the ability of G17DT to     generate antibodies before and after treatment of biliary obstruction due to advanced     pancreatic cancer.   "
90748|NCT02098278|"     The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with     chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and     chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride     clearance.      This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for     12 weeks during the 13 week treatment period.   "
90749|NCT02098265|"     The purpose of this research is to determine if two non-invasive brain stimulation     techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can     increase the extent of stroke recovery.   "
90766|NCT02098044|"     The OA and Football Study is an epidemiological study designed to establish the prevalence of     knee osteoarthritis in retired professional footballers. The study will also identify the key     risk factors associated with knee osteoarthritis. The study is comprised of three phases:     Phase I involves the dissemination of a questionnaire (demographic details, players history,     injury and surgery and other known risk factors of OA), Phase II is a radiographic study that     involves x-rays in a sample of footballers both with and without knee pain and Phase III is a     case control study which will compared retired professional footballers with age-matched     controls recruited from the general population in the East Midlands region.   "
90767|NCT02098031|"     Undernutrition and growth restriction due to poor diet and inadequate nutrient intake     continues to be a global challenge, particularly in the developing countries including     Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources     or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect     brain and cognitive development.      This study aims to evaluate nutrient intake, growth and cognitive function among children     between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western     Uganda. The investigators hypothesize that nutrition education to mothers can bring about     improved dietary intake and nutritional status among children aged 6-36 months.   "
90750|NCT02098252|"     The objectives of this study and registry are to offer the best management possible for     patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of     long-term outcomes, despite the presence of uncertainty. Management may include     interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or     in combination) or conservative management.      The trial has been designed to test a) whether medical management or interventional therapy     will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an     absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and,     b) to test if endovascular treatment can improve the safety and efficacy of surgery or     radiation therapy by at least 10% (80% to 90%).      As for the nested trial on the role of embolization in the treatment of Brain AVMs by other     means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the     number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can     be accomplished with an acceptable risk, defined as permanent disabling neurological     complications of 8%.   "
90751|NCT02098239|"     The study was designed to assess the effect of jaundice on the ability of G17DT to generate     antibodies before and after treatment of biliary obstruction due to advances pancreatic     cancer.   "
90752|NCT02098226|"     The study objective is to confirm that the MBT-CA System identifies medically significant     bacteria and yeasts from an isolated colony from any sample type processed by the clinical     laboratory. For this purpose MBT-CA test results will be compared to bi-directional     sequencing results.   "
90753|NCT02098213|"     Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of     plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.   "
90754|NCT02098200|"     The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.      It is a percutaneous catheter-based device designed for tricuspid valve repair in order to     decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve     regurgitation.   "
90755|NCT02098187|"     The purpose of this early feasibility study was to investigate the pharmacokinetics of     MP-3180 administered in rising doses and to evaluate the use of the Optical Renal Function     Monitor (ORFM), an investigational noninvasive fluorescence detection device.   "
90756|NCT02098174|"     The purpose of this study was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg)     compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in     healthy adult participants. The secondary objective was to evaluate the safety and     tolerability of MP-3180 in healthy adult participants.   "
90757|NCT02098161|"     To goal of this clinical research study is to learn if LCL161 can help to control     myelofibrosis. The safety of this drug will also be studied.   "
90758|NCT02098148|"     The primary purpose of this study is to investigate whether administration of xenon reduces     symptoms of Obsessive-Compulsive Disorder (OCD). Xenon is a naturally occurring gas that has     been used in clinical settings both as a general anesthetic agent and as a contrast agent for     computed tomography (CT) scans. Investigators believe that xenon may be effective in reducing     symptoms of OCD due to its ability to reduce the activity of a specific brain chemical called     glutamate, which has been shown to be abnormal in the brains of people with OCD.      It is important to understand that this study uses a placebo, or inactive, treatment. In this     study, the placebo treatment is inhalation of room air (instead of xenon). All participants     will receive both xenon and placebo treatments at some point over the course of the study.     However, neither the participants nor the study investigators will know which treatment you     are receiving.   "
90759|NCT02098135|"     stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality,     interia sensor,        -  Trial with medical device   "
90760|NCT02098122|"     Functional recovery following SCI in adults is limited. Improvements in the quality of life     of affected persons are associated with the recovery of functions that allow independent     living, for example use of the arms and hands. Rehabilitative training has been shown to aid     upper limb recovery. However, there are likely vast differences in the amount of time     individuals spend actively training (during rehabilitation sessions in the clinic) and what     they do in their non-training time (during daily life). The activity, or lack of, during the     non-training period could interfere (positively or negatively), with the specific training in     the rehabilitation session. However, there is little information available about this.      Inertial measurement units are increasingly being used in human movement and rehabilitation     research. The use of such technology is a promising approach to rapidly and discreetly     collect objective movement information. The investigators plan to introduce a novel,     long-term, activity sensor into clinical SCI rehabilitation. The investigators use this     sensor to precisely measure movement of the upper limb over extended periods of time. Upper     limb activity recordings from these sensors allow us to detail the amount and duration of     activity during specific periods of upper limb rehabilitation and recovery.      The investigators aim is to measure upper limb activity. The investigators aim to track     changes in the activity of the upper limb during recovery and rehabilitation in patients with     cervical SCI as well as collect reference values of upper limb activity in chronic sufferers.     The recordings from this activity sensor will provide a more detailed understanding of how     everyday upper limb activity contributes to functional recovery.   "
90761|NCT02098109|"     This study will compare the results of stem cell mobilization using drugs called filgrastim     (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02     filgrastim (Granix) and plerixafor.   "
90762|NCT02098096|"     The purpose of this study is to develop a negative work exercise regimen as an intervention     for posttraumatic osteoarthritis (PTOA). Negative work is the force produced by muscles as     they lengthen, and regularly occurs with common activities such as lowering an object from a     shelf or walking down stairs. In this study, the investigators are examining the     effectiveness of negative work exercise over a 12-week period in older, male, Veterans.   "
90829|NCT02097225|"     This phase I trial studies the side effects and best dose of onalespib when given together     with dabrafenib and trametinib in treating patients with melanoma or solid tumors that have     spread to another place in the body (metastatic) or cannot be removed by surgery and have     come back after previous treatment (recurrent). Onalespib, dabrafenib, and trametinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
90772|NCT02097966|"     The primary objective of this program is to provide Daclatasvir in combination with     Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high     risk of liver decompensation or death within 12 months if left untreated and who have no     available therapeutic options.   "
90773|NCT02097953|"     The purpose of this study is to understand how an antibiotic, rifampin, may change the blood     levels of another antibiotic, daptomycin, in the body. In addition, the effect of     polymorphisms in P-glycoprotein (a protein involved in the removal of daptomycin from the     body) on the blood levels of daptomycin will be evaluated. The hypotheses are that rifampin     will decrease the blood levels of daptomycin and that the effect will be greater for certain     P-glycoprotein polymorphisms.   "
90774|NCT02097940|"     This study presents the hypothesis that the sensory processing engine improves balance and     agility for football athletes.   "
90775|NCT02097927|"     The study will be a 3-way crossover design: it will assess the impact of consuming a beverage     enhanced with satiety-relevant properties on subjective ratings of appetite and on energy     intake compared with a low energy version with the same sensory characteristics, and a     non-sensory enhanced high energy control.      In addition, saliva samples will be collected at regular intervals for the identification of     novel biomarkers of energy intake.   "
90776|NCT02097914|"     The burden of tobacco use falls disproportionately on low-income populations, through high     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in     creating smoke-free environments in the U.S over the past two decades has left smoker's homes     as one of the primary sources of exposure to secondhand smoke for both children and     nonsmoking adults. Intervention research that identifies effective and practical strategies     for reaching the minority of households that still allow smoking in the home has considerable     potential to reduce smoke exposure, but suitable channels to reach low-income families are     limited.      The proposed research will systematically test an intervention designed to create smoke-free     homes in low income households among 2-1-1 callers. During this randomized control trial,     researchers will disseminate and evaluate a brief smoke-free homes intervention through the     established infrastructure of a Texas 2-1-1 call center. 2-1-1 is a nationally designated     3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory     assistance, that links callers to community-based health and social services. The main     hypothesis to be tested is that a higher proportion of households in the intervention group     will establish and maintain a smoke-free home than in the measures-only control group.   "
90777|NCT02097901|"     The hypothesis is that microfractures in the footprint of the humerus will aid to improve the     tendon healing to the bone. The aim of the study is to investigate whether the use of     microfractures at the footprint of the rotator cuff will improve the tendon healing when     reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to     repair with or without microfracture.   "
90778|NCT02097888|"     This will be a prospective observational study. The investigators will compare Erythropoietin     (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone     metabolism in healthy volunteers living at different altitudes.   "
90779|NCT02097875|"     Many types of cancer are primarily treated with surgery and patient survival is directly     related to the extent to which the tumor is able to be removed. It is often difficult for     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have     spread from the original tumor site, resulting in incomplete removal of the tumor and reduced     patient survival. In addition, in some sites, such as the brain, it is critical to avoid     damage to normal tissue around the tumor to prevent adverse effects of surgery on function.     We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize     the edges of the tumor and small groups of cancer cells that have spread to other sites in     real-time, as they operate.   "
90780|NCT02097862|"     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the disease pathology of patients with     diagnosed degenerative disc disease.   "
90781|NCT02097849|"     Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria     toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have     been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon     (IFN).      Secondary objective is to evaluate the immune response to vaccination with 23-valent     pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response]     and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T     cell-dependent neoantigen response].   "
90819|NCT02097355|"     TriVox Health is an online system designed to make it easy for healthcare providers to     monitor patients' disease symptoms and functioning over time and in between in-person visits     (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and     randomized clinical trial methods, we will evaluate the impact of TriVox on the health     outcomes, patient/family experience of care, and healthcare utilization for children and     adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism, depression,     and epilepsy.   "
90782|NCT02097836|"     If a child with cerebral palsy does not develop independent sitting balance by 4 years of     age, their prognosis for walking is very poor. Surprisingly little is known about how to     facilitate head control or upright sitting balance and functional mobility in the child who     is not developing these skills. This is one of the first studies that will examine     intermediate stages in the development of the postural control system in children with     neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have     developed a method called Targeted Training in which trunk control is trained in children     segment by segment using a specific training device. This study aims to examine kinematic and     electromyographic changes in a case series of children who undergo a 6-month Targeted     Training intervention.   "
90783|NCT02097823|"     The purpose of this study is to determine the feasibility of a larger trial comparing     olanzapine and aprepitant and to obtain preliminary data on the effectiveness of these two     medications to treat nausea and vomiting in children receiving chemotherapy. Children     receiving 2 cycles of chemotherapy with a high risk of causing nausea and vomiting will     receive olanzapine in one cycle and aprepitant in another cycle. Children will be randomized     to see which medicine they receive first. The investigators will record the number of extra     medications used for nausea, the number of times a child vomits, and the amount of nausea the     child feels each day.   "
90784|NCT02097810|"     Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded     by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1     (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or     more of these targets are present in several different tumor types, including non-small cell     lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer,     pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer     with a detectable molecular alteration in targets of interest may be eligible for enrollment.      Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation     scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in     the dose expansion portion of the study.   "
90785|NCT02097797|"     Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that     the intestinal flora is involved in the disease and it has been show that patients with     Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The     purpose of this study is to determine the effect of the fecal flora transplantation on     Crohn's disease.   "
90786|NCT02097784|"     This prospective study focuses on the interest of the echocardiography for cirrhotic     patients, who present acute kidney injury corresponding to the criteria of hepatorenal     syndrome. This echocardiography will be done before the volemic expansion and the final     diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe     the hemodynamic characteristics of this population at the time of acute kidney injury and     their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients with     elevated filling pressure, predicting poor outcome of volemic expansion will be excluded of     the study after the echocardiography and will not undergo volemic expansion but appropriate     management.   "
90787|NCT02097771|"     Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks     airways: LMA SupremeTM vs Ambu AuraOnceTM   "
90788|NCT02097758|"     Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is     useful for evaluation of defect size and shape. The investigators suggested optimal device     size using three-dimensional transesophageal echocardiographic image and our formula in     previous study.      Purpose: In this study, the investigators seek to predict the correct device size and confirm     the accuracy of the formula that we made before device closure in ASD patients.   "
90789|NCT02097745|"     This study will assess the long-term safety and efficacy of repeating treatment with     MabThera, in combination with methotrexate and steroids, in patients who were previously     randomized into MabThera study WA17042. The anticipated time on study treatment is until     Mabthera is available on the local market and the target sample size is 100-500 individuals.   "
90790|NCT02097732|"     This is a study to test the efficacy of using standard immune therapy for melanoma prior to     stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery     followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good as     or better than controlling brain metastases as compared to stereotactic radiosurgery followed     by immune therapy.   "
90791|NCT02097719|"     This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared     to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming     solution) in patients who require IOP lowering therapy.   "
90792|NCT02097706|"     Borderline Personality Disorder (BPD) is one of the most prevalent psychiatric disorders with     high morbidity and mortality. It affects the lives of millions worldwide and is often highly     incapacitating, leading to significant psychosocial dysfunction. Moreover, nearly all     patients have experienced suicidal ideation and about 10% actually commit suicide, a rate     almost 50 times higher than in the general population. Mostly young women are at greater risk     for the disorder and are three times more likely to be diagnosed with BPD than men.      BPD aetiology is complex and could be explained by both biological and environmental factors.     Among the environmental factors, sexual or physical abuse, parental divorce, loss or     illnesses are identified as the most common ones. These factors can induce dysfunctional     behaviours, which might cause emotional dysregulation, high impulsivity and frequent self-     injurious behaviour.      However, there are no pharmacologic interventions that are known to be specifically effective     to treat BPD. Therapeutic options for this devastating disorder is still far from adequate     for treating acute illness episodes, relapses, and recurrences and in restoring premorbid     functioning. In addition, some patients are unable to tolerate existing therapies for BPD,     which leads to either frequent changes in medications or to non-adherence. Therefore there is     an urgent need for the development of more rapidly effective treatments for BPD.      A growing body of evidence suggests that glutamatergic neurotransmission, in particular     N-methyl-D-aspartate (NMDA) subtype may play a role in the pathophysiology of multiple     psychiatric disorders. This has led to various clinical trials with glutamate modulating     drugs. The trial drug is an uncompetitive NMDA receptor antagonist approved for Alzheimer's     disease is increasingly being studied in a variety of non-dementia psychiatric disorders.     Results from these studies have proved that the trial drug was safe and well tolerated and     has the potential for use in the treatment of psychiatric disorders.      To date, there are no published data on the use of trial drug in the treatment for BPD.     Therefore, the investigators intend to study the efficacy of this novel drug as an addition     to ongoing therapy with atypical antipsychotics in patients with Borderline Personality     Disorder. This study will recruit 30 BPD patients. The patients will be randomly allocated to     receive either the study medication (20mg/ day) or placebo via oral administration for eight     weeks. To observe the efficacy of the trial treatment, all participants will be assessed at     various time intervals for different borderline and cognitive symptoms.   "
90793|NCT02097693|"     There are limited therapeutical options for patients with secondary dystonia due to cerebral     palsy. Pharmacotherapy is often without effect, or side effects are severe. Meanwhile deep     brain stimulation (DBS) has proven to be a safe and effective therapy for patients with     parkinson´s disease or primary / idiopathic dystonia. Experiences with DBS in patients with     dyskinetic cerebral palsy are limited with heterogeneous data.      With STIM-CP we investigate the effect of DBS on quality of life in young patients with a     dyskinetic movement disorder (dyskinetic cerebral palsy) due to perinatal hypoxic brain     injury. Additionally, the effect of DBS on motor development, speech, memory, attention,     cognition and pain perception will be assessed. In total, 20 patients aged 7-18 years     diagnosed with dyskinetic cerebral palsy, who will receive DBS, should be included. 11 German     DBS-centres will participate in the trial.      We assume that DBS reduces the severity of dystonia and improves the quality of life in these     patients.   "
90804|NCT02097550|"     This project seeks to improve the health of patients with chronic kidney disease (CKD) by     developing and testing an electronic health intervention (that will combine secure e--mail,     smartphone text message, and online video materials) to promote patient use of effective     medications. The information we collect on the electronic health intervention will guide     future research, including a larger trial and other studies among related patient groups     (e.g., racial minorities) and diseases (e.g., type 2 diabetes mellitus). The project has the     potential to improve health outcomes for the millions of patients with CKD who are not yet     receiving effective medications.   "
90794|NCT02097680|"     It seems plausible that increased aromatase activity in obese men, as a result of a larger     fat mass, is responsible for decreased levels of testosterone. Therefore aromatase inhibition     increases testosterone levels, which may affect hepatic and cardiac function.      In this intervention study two groups of hypogonadal obese men are compared. Group A is     treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a     group with normal testosterone and low oestrogen concentrations. Group B is treated with     placebo once every two days during four months; this group will retain low testosterone - and     high oestrogenic concentrations.      The primary objective of the study is to evaluate effects of changed sex steroids in obese     men on hepatic and cardiac function.   "
90795|NCT02097667|"     Fetal Growth Restriction (FGR) is a major obstetric problem, affecting 1.46 million fetuses     worldwide each year and contributing to 50% of stillbirths. Severe early onset FGR affects 1     in 500 pregnancies, leading to stillbirth or the need for delivery before 28 weeks gestation.     The combination of FGR and prematurity is associated with a significant risk of neonatal     mortality and short and long-term complications. Even modest increases in birthweight (e.g     from 500 to 600g) and gestation at delivery (e.g from 26 to 27 weeks) are associated with     significantly better outcomes but there are currently no treatments.      The EVERREST Clinical Trial, funded by the European Commission, aims to develop a treatment     which will increase fetal growth in severe early onset FGR. It will use gene therapy injected     into the uterine arteries of the mother to increase the levels of vascular endothelial growth     factor (VEGF) and so increase uterine artery blood flow and fetal growth.      The EVERREST prospective study aims to form a clinical database and biobank of pregnancies     affected by severe early onset FGR to improve understanding of the condition and serve as a     comparison to assess the safety and efficacy of this intervention.      The prospective study will take place across four European centers who will later take part     in the EVERREST Clinical Trial. Women with singleton fetuses with early onset FGR will be     approached to take part in the study. Participating women will provide blood samples, details     of their clinical condition, samples of umbilical cord blood, placenta and myometrial and     placental bed biopsies at the time of Caesarean section (if needed). Data on short and     long-term outcomes of the babies will be collected. All data will be entered onto a central     database for eventual use as a comparator for treated women on the EVERREST Clinical Trial,     for which separate ethical approval will be sought.   "
90796|NCT02097654|"     Primary Objective: To quantify the benefits of the SENATOR decision support software on the     reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the     effect of SENATOR with regard to use of appropriate non‐pharmacological therapies in subjects     with one core geriatric syndrome.      Tertiary Objectives: to examine the association of SENATOR use with subject survival,     morbidity and health related quality of life.      Health Economic Objective: To examine the potential health economic consequences of using     SENATOR.      There are two study periods:      Period I: Prospective multinational, multicentre observational study to estimate the baseline     adjudicated medical and surgical ADR rates by clinical sub speciality in 6 international     sites.      Period II: Prospective multinational, multicentre, cluster randomized, two parallel arm, open     label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR     software in reducing ADRs in older hospitalized subjects.   "
90797|NCT02097641|"     This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study to assess     the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal     Stem Cells infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study     is the extension of the Phase 1 pilot study (NCT01775774). Patients will be randomized to     receive Human Mesenchymal Stem Cells infusion or placebo in a 2:1 allocation. Patients will     be followed daily for adverse events through day 28, death or hospital discharge, whichever     occurs first. Vital status will be collected at 6 and 12 months after study enrollment.   "
90798|NCT02097628|"     The purpose of this study is to compare volume- and pressure- controlled ventilation with     laryngeal mask airway Guardian in obese patients undergoing laparoscopic gynecologic surgery     in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and     complications.   "
90799|NCT02097615|"     At present research has generated controversy regarding the utility of antiseptics in wound     management for diabetic foot ulcers syndrome. However, these studies have been done in     tissues and animal models. This study involves the best presently antiseptic for residual     effect and low toxicity in an approach to eliminate microorganisms promoters formation of     biofilm, contributing to the treatment for accelerated closure the diabetic foot ulcers     syndrome .      So it is necessary to determine if irrigation ulcer diabetic foot syndrome with chlorhexidine     0.125 % aqueous solution determines the decrease of the surface to a greater extent than the     standard treatment using irrigation with sterile deionized water .   "
90800|NCT02097602|"     This is an observational study designed to monitor the course of the fraction of reticulated     platelets and the correlation thereof to major adverse cardiac and cerebrovascular events     after noncardiac surgery.   "
90801|NCT02097589|"     The purpose of this research study is to: Improve the effectiveness of vaccinations by     identifying the effect of cholesterol medication, statins, on immune responses.   "
90802|NCT02097576|"     The purpose of this study is to evaluate whether high-volume nasal rinses with a manuka     honey/saline mixture will improve symptom scores, nasal endoscopic findings and CT scan     findings compared to nasal saline rinse without manuka honey in patients with chronic     rhinosinusitis.      Manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in New     Zealand. It has been shown to have antibacterial activity against common bacteria that cause     chronic sinusitis.   "
90820|NCT02097342|"     This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients     with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function     will be studied.   "
90821|NCT02097329|"     To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist     and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.   "
90803|NCT02097563|"     The present study aims to :        1. compare different approaches (high intensity vs. low intensity) to training community          providers (those who routinely treat young patients with bipolar disorder, psychosis, or          sub-threshold high-risk conditions) on the implementation of family-focused treatment          (FFT);        2. assess the cost of FFT training and implementation support; and        3. determine whether these different forms of clinician training are associated with          different outcomes over 1 year among patients with early-onset mood and psychotic          disorders.   "
90805|NCT02097537|"     The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation     challenge in children with bronchial asthma.   "
90806|NCT02097524|"     The main purposes of this study are to describe the pharmacodynamic effects, safety and     pharmacokinetics of a single dose of sarilumab.   "
90808|NCT02097498|"     The overall objective of the present proposal is to assess whether medical simulation can     enhance the safety and proficiency profile of paramedics performing prehospital endotracheal     intubation, and whether feedback from an airway management expert observing the simulation     enhances skill retention after 12 and 24 months. Since no validated proficiency assessment     tool currently exists to measure the skill of paramedics in airway management, one will be     developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo     simulation training similar to that required for certification. A baseline assessment of     proficiency will be obtained. One group will be randomized to receive simulation training     similar to that required for certification, while the other group will receive feedback from     an airway management expert linked to the simulation test site via a 2-way audio-video feed.     Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill     level was maintained or whether skills deteriorated, and whether expert intervention had any     impact on skill retention.   "
90809|NCT02097485|"     The purpose of the study is to evaluate ovicidal efficacy of a single application of     abametapir lotion 0.74% w/w intended for the treatment of head lice.   "
90810|NCT02097472|"     The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered     intramuscularly to healthy Kenyan adults and toddlers who have been primed with a     pneumococcal conjugate vaccine (PCV).      Additionally, the study will explore whether a measurable immune response is elicited when     PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.   "
90811|NCT02097459|"     It suggests in the Guideline that the postmenopausal women with breast cancer who have taken     selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from     changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized     and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to     AIs in perimenopausal and recently postmenopausal women with early-stage hormone     receptor-positive breast cancer.   "
90812|NCT02097446|"     -  Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous          cystadenoma)        -  Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)        -  Primary Outcome Measure : Anti-adhesion Rate        -  Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative          Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)   "
90813|NCT02097433|"     As part of the global clinical development program for Dacomitinib, studies are planned in     cancer patients in China. An assessment of Dacomitinib pharmacokinetics in Chinese subjects,     as required by the Chinese Health Authorities, is therefore warranted.      The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.   "
90814|NCT02097420|"     The purpose of the study is to provide evidence of safety and effectiveness of the study     valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is     too small for the currently commercially available valves ranging in size from 16mm to 37mm.   "
90815|NCT02097407|"     Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective     randomised study, we determined whether preoperative dexmedetomidine administration could     reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM     insertion without muscle relaxants.   "
90816|NCT02097394|"     The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora     drugs(Bifidobacteria) can decease recurrence rate of colon polyps   "
90817|NCT02097381|"     HIV infection is associated with a state of chronic, generalized immune activation that has     been shown in many studies to be a key predictor of progression to AIDS. The molecular,     cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation     are complex and still poorly studied. There is, however, growing consensus that both viral     and host factors contribute to this phenotype, with emphasis on the role played by the     mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known     that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation     4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation     and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under     combined antiretroviral therapy (cART) remains poorly understood.      This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1     and Th17, in blood and colon samples collected from HIV-infected individuals before and after     a short term cART.   "
90818|NCT02097368|"     The main objective is prospectively study the upper airways function in an adult population     of neuromuscular patients. The main measurement will be the evolution of tongue strength     recorded each year during annual clinical evaluation on a 5 years period.   "
90830|NCT02097212|"     The investigators hypothesize that there is a strong correlation between OSA and TBM/HDAC.     Our hypothesis is based on the similarities in mechanism (airway collapse), symptoms (daytime     and nocturnal dyspnea) predisposing conditions (obesity and neuromuscular abnormalities of     the chest wall and the diaphragm), and effect of interventions (CPAP and BIPAP) in these     diseases.   "
90831|NCT02097199|"     This study investigates the influence of an increased physical activity and sports workload     in formerly nonsporting healthy individuals on current promising biomarkers of     atherosclerosis research.   "
90854|NCT02096900|"     The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam     and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time     of separation, and ease of mask acceptance at induction in children. Subjects will be     randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to     surgery. No placebo will be administered in this study. Subjects will be male and female     children between 2 and 9 years of age. In total, subject participation will last     approximately the duration of their preoperative, perioperative, and immediate postoperative     period. A member of the research team will recruit subjects preoperatively in the operating     room holding area prior to surgery. Consent will take place at the time of recruitment in the     preoperative holding area following a detailed explanation of the study and medications     involved in the study. Participants will be of ASA (American Society of Anesthesiologists)     class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to     remain inpatient for at least 23 hours postoperatively.   "
90832|NCT02097186|"     Major vascular surgery involves operations to repair swollen blood vessels, clear debris from     blocked arteries or bypass blocked blood vessels. Patients with these problems are a     high-risk surgical group as they have generalized blood vessel disease. These puts them at     risk of major complications around the time of surgery such as heart attacks , strokes and     death. The mortality following repair of a swollen main artery in the abdomen is about 1 in     20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple     and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote     ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to     muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a     further five minutes. This cycle is repeated three more times. The blood supply is     interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated     brief interruption of the muscular blood supply sends signals to critical organs such as the     brain and heart, which are rendered temporarily resistant to damage from reduced blood     supply. Several small randomized clinical trials in patients undergoing different types of     major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial     aims to determine whether RIPC can reduce complications in routine practice.   "
90833|NCT02097173|"     This study is conducted to assess the relative bioavailability of MTX administered     subcutaneously via a prefilled pen (50mg/mL) compared with MTX administered via IM injection     (25mg/mL).   "
90834|NCT02097160|"     The study is a parallel interventional randomized dose-response trial designed to improve     vitamin D intakes through food in a group of healthy 2 - 7.9 year old children. Subjects will     be recruited from the general population in the greater Montreal area. The study will be     conducted at the Mary Emily Clinical Nutrition Research Unit of McGill University. Children     will be required to attend two study visits. Some information will be collected through     monthly telephone survey to the parents. The investigators will add vitamin D to cheese and     yogurt for daily consumption at home over a three month period. All products will be provided     to the parents in the form of coded containers that do not contain any labels aside from the     group and expiration date. Ingredient lists will be provided upon consenting to the study. To     better understand vitamin D status; dietary intake, hematology, serum biochemistry including     25(OH)D, growth, and body composition will be measured at the beginning and end of the three     month study period. In addition, bone mass at baseline will be assessed. Sun exposure will be     documented and a skin pigmentation test will be used to more objectively assess chronic sun     exposure. The investigators will also investigate the association between vitamin D intake     and status with immune function.   "
90835|NCT02097147|"     To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually     active healthy adults.   "
90836|NCT02097134|"     This pilot clinical trial studies whether unilateral group D retinoblastoma, or     retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can     be treated with a new technique for delivering chemotherapy directly into the blood vessel     that supplies the affected eye. This new technique is called intra-arterial injection. This     may give children with unilateral retinoblastoma a lower chance of needing surgery to remove     the eye and reduce the amount of treatment side effects.   "
90837|NCT02097121|"     This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) for the     treatment of urinary incontinence due to overactive bladder in pediatric patients between the     ages of 12 to 17 years who have not been adequately managed with anticholinergics.   "
90838|NCT02097108|"     This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to     evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen     after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.      This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV     infected women from a PI based regimen to raltegravir.   "
90839|NCT02097095|"     This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which     biological samples will be collected for future investigations on biological correlates,     markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, A     phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy,     safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342     (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic     region, (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled     in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but     will have additional blood samples collected for the sub-study.   "
90840|NCT02097082|"     An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold     (DRS) system for the treatment of patients with obstructive superficial femoral artery     disease.   "
90841|NCT02097069|"     The investigators aim to compare the effect of different inositol stereoisomers     supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant     women with GDM and in preventing adverse obstetric outcomes.      The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid     400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250     mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a     day).      Folic acid or inositol stereoisomers will be administered starting at the enrolling time     (24-28 week gestation, after GDM diagnosis) till the delivery.      The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index     (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28     weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin     therapy and insulin dosage will be registered.   "
90855|NCT02096887|"     Patient's awareness of their risk factors for heart disease and their active involvement in     their own management plan can help improve their adherence to treatment and their risk     profile. The purpose of this study is to investigate the influence of patient education and     awareness of heart disease risk factors on compliance to medication and lifestyle     modification.   "
90856|NCT02096874|"     Ultra-wide field fluorescein angiography can detect the response of anti VGEF therapy such as     Avastin on retinal ischemia in the setting of diabetic macular edema.   "
90857|NCT02096861|"     This study is to assess noninferiority in efficacy and to assess overall safety of CT P13     compared to Remicade in patients with active Crohn's disease up to Week 54.   "
90845|NCT02097017|"     To examine whether application of lidocaine spray in cervical preparation for second     trimester dilatation and evacuation alleviates pain and is superior to current protocol of     preparation without analgesia and superior to placebo.      Methods A prospective randomized placebo controlled trial consisting of three groups        1. Lidocaine spray group (group 1)        2. Placebo group (saline spray) (group 2)        3. No intervention group (as currently in our protocol) (group 3)             -  Women undergoing dilatation and Evacuation in the second trimester and are about to               go cervical dilation with osmotic dilators(laminaria) will be invited to               participate in the randomized placebo control trial comparing lidocaine spray,               placebo (saline) or no application (as current protocol).             -  Informed consent will be obtained from each participant             -  After enrollment patient will be randomized into one of the three study arms by a               computer program             -  The patient will be placed in the lithotomy position and the cervix will be exposed               using a sterile bivalve speculum.             -  Pain will be assessed in 3 places using a visual analog pain scale 10(no pain) to               100 (worst possible pain).                0 after removal 15             -  Group1 :after speculum insertion 4 puffs (40mg) of spray will be applied to the               cervix and after a 2 minute wait laminaria will be inserted.             -  Clinical data will be collected including age, parity, general health, Obstetric               and gynecologic history.             -  Primary outcome : difference in pain score immediately after speculum removal and               10 minutes after speculum removal             -  The protocol will not be repeated if a participant is to return for further               laminaria insertion.      Sample size A sample size was calculated assuming a target difference of 10 (smallest effect     of clinical importance) between the baseline and post laminaria pain score at 15 minutes.     Standard deviation was assumed to be 18 based on similar power. Assuming 80% power and a P     value of 0.05 sample size of each group was calculated to be 51(5) and hence sample size of     55 was determined .      Participants        -  Females aged 16 years and older about to undergo DE Inclusion criteria        -  Informed consent        -  Women with a fetus Crown rump length (CRL) greater than 10 weeks via ultrasound.      Exclusion criteria        -  CRL < 10 weeks        -  Clinical Uterine size >22 weeks        -  Fetus Bi Parietal Diameter > 50 mm        -  Known amide allergy Withdrawal criteria        -  Immediate adverse reaction to amides   "
90846|NCT02097004|"     A randomized, Open label, Single center, Prospective study to compare efficacy and safety of     Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on     Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological     Response Induced by Entecavir   "
90847|NCT02096991|"     -  Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of          estrogen.        -  Previous studies reported that BPA exposure is associated with increased risk of          cardiovascular diseases.        -  Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one          of the well established source.        -  The investigators hypothesis is that increased BPA exposure from canned beverage would          disrupt normal physiology in a short term.        -  In the present trial the investigators are to investigate whether increased BPA exposure          by consuming canned beverage actually affect cardiovascular indices and epigenetic          feature.        -  For this aim, the investigators will conduct a cross-over trial.   "
90848|NCT02096978|"     The study will be conducted to compare two alternative techniques for dental implant     placement. Both of the techniques - Osteotome and Conventional Drilling Techniques for the     preparation of the implant sites (osteotomies) are accepted standards of care. The goal of     the study will be to compare implant stabilities achieved with two techniques by measuring     resonance frequency for each implant placed using the diagnostic device, the Osstell machine,     that measures stiffness of the bone/implant system non-invasively. The data are represented     in a quantitative value - implant stability quotient (ISQ), where a higher value indicated a     higher implant stability. Since it has been well documented in the scientific literature that     primary (at the time of implant placement) implant stability is a strong prerequisite for     implant success (osseointegration and subsequent function on loading), the results of this     study will guide the implant team in choosing the right surgical treatment protocol - the     protocol that will be aimed for higher implant stability, and, therefore, for higher     long-term implant success.   "
90849|NCT02096965|"     In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg     at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine     volume and reduce urine supersaturation and to be well tolerated by patients with kidney     stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen     is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect     during the night. To this end, a higher dose is used in the morning, with a lower dose in the     afternoon.   "
90850|NCT02096952|"     The purpose of this study is to determine whether methylphenidate hydrochloride extended     release liquid formulation is safe and effective in the treatment of     attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism     spectrum disorders (ASD).   "
90851|NCT02096939|"     Patients with primary aldosteronism, which is the most prevalent form of secondary     hypertension, have an increased rate of cardiovascular events, compared to patients with     essential hypertension, even with equal severity of hypertension. This might be partially     attributed to the association of increased aldosterone levels with insulin resistance. How     this relation can be explained from a pathophysiological point of view, is insufficiently     established.      Recently, microvascular dysfunction has been proposed as a link between insulin resistance     and hypertension. Loss of NO-mediated vasodilation is an important feature of microvascular     dysfunction; in addition, an impaired insulin-mediated microvascular NO production has been     suggested to underlie the reduction in insulin-stimulated glucose disposal that is     characteristic of insulin-resistant states. Increased aldosterone levels are not only     associated with insulin resistance, but also with endothelial dysfunction. In addition, they     interfere with the vascular effects of insulin.      Therefore, the investigators hypothesize that in patients with primary aldosteronism,     increased aldosterone levels induce microvascular dysfunction through reduction of     NO-availability, which contributes to the development of insulin resistance, and of     hypertension, in addition to the sodium-retaining effects of aldosterone.   "
90852|NCT02096926|"     This is a single center placebo controlled, prospective, randomized study on healthy adults     undergoing third molar surgery.   "
90853|NCT02096913|"     The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and     feasibility of small molecule (Ibuprofen) mediated Rho-inhibition as putative     neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety     analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the     feasibility of recruitment procedure, and oral administration of the compound within the     multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the     pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be     investigated. Secondary endpoints will permit preliminary statements about effects on     neuropathic pain, spasticity, and neurological function.   "
93512|NCT02062073|"     Purpose of this study will be to determine the potential of abametapir lotion to induce     sensitization by repeated topical application to the healthy skin of humans under controlled     conditions.   "
90858|NCT02096848|"     Studies which describe the bacterial aetiology and antimicrobial susceptibility in AOM     children in Latin America are scarce. Interestingly, when the MEF microbiology was analyzed     among 1,108 children aged 2-92 months with OM between years 2002 and 2007, non-typable H.     influenzae was the most common pathogen isolated from the MEF of children with a otitis media     failing to appropriate antimicrobial therapy.      PCV-7 (3 + 1 regimen) was introduced into the Costa Rican national immunization program in     January 2009 and in August/September of 2011, it was changed for PCV 13 (-2+1 regimen).     Following PCV-7 universal introduction in Costa Rica, between March of 2010 and January of     2011, MEF samples from Costa Rican children with OM, having received 0-4 PCV 7 vaccine doses,     were obtained via tympanocentesis (88%) or from spontaneous otorrhoea (12%). It was     interesting to observed that among the initial 134 OM episodes, the most common bacterial     pathogen identified was H. influenzae (55%) followed by S. pneumoniae (31%) and that among     the S. pneumoniae episodes, 55% were already non-PCV-7 serotypes and that 25% of these     isolates were multi-drug resistant.      The primary objectives of the study are to analyze the effect of early universal utilization     of PCV-13 in Costa Rican children with the number of H. influenzae and PCV-13- S. pneumoniae     positive MEF cultures by comparing the data collected prospectively and by the same group of     investigators that have collected the original data since 1992, from children for the     post-PCV-13 introduction with anonymised information collected retrospectively pre-PCV-7 data     (1999-2004) during a transition period in which PCV-7 was used in only the private settings     (2005-2008) and during universal use of PCV-7 (2009-September 2011).   "
90859|NCT02096835|"     The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in     women scheduled for gynecologic laparoscopic surgery with general anesthesia.   "
90860|NCT02096822|"     Preterm infants undergo very frequent painful procedures during neonatal care particularly     during the first few days. The support for the pain of the preterm is a priority for nurses     and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose     ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose     is limited to 4 administrations per day which is insufficient compared to the average of     daily painful procedures. So, validation of an effective non-pharmacological intervention to     relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm     less than 37 GA during heel stick procedure with the PIPP score but no study looks for the     benefit for pain relief of the association of non-nutritive sucking and facilitated tucking     during heel stick procedure.   "
90861|NCT02096809|"     Objectives        -  To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system 1          week after implantation        -  To evaluate the short term soft tissue healing and the long term skin reaction, with the          new Cochlear BI300/BA400 implant system using the linear incision without subcutaneous          tissue reduction.        -  To produce reference data regarding the stability of the BI300/BA400 implant system.      Study design: Prospective cohort study. Patients: 24 adults with anticipated normal skin and     bone quality eligible for bone anchored implant surgery.      Intervention: Loading of the sound processor one week after surgery Main outcome measures:     Implant stability, soft tissue reaction, skin overgrowth, pain and numbness will be assessed.      It is hypothesized that implant loading can be performed one week after surgery without any     changes in implant stability, soft tissue reaction, skin overgrowth, pain or numbness around     implant.   "
90862|NCT02096796|"     Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment     Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood     pressure in forearm muscle compartments. No strategies nor methods have been used to diminish     the risk to suffer from arm pump within motor cross.      This project aims to look at ergonomics of driving and its relationship with the occurrence     of arm pump.      The investigators will first investigate the experience of motor cross athletes with arm pump     through motor cross federations in Belgium and The Netherlands (survey).      Two groups of athletes will be selected (20 persons within each group) who will be invited to     the motor cross track to investigate their hand grip strength, motor driving position, muscle     activity.   "
90863|NCT02096783|"     This randomized pilot clinical trial studies the feasibility of a pre-operative and/or     post-operative scripted sexual health informational intervention and how well it works in     improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and     counseling options with patients may help improve sexual outcomes and/or anxiety after     primary gynecologic cancer treatment.   "
90864|NCT02096757|"     Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral     supplementation will improve will improve systemic inflammation and patency of peripheral     vascular intervention (PVI).   "
90866|NCT02096731|"     Background: Recent observational studies have reported possible arrhythmogenic effects with     long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been     associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object     of a recent signal in trials of LABAs submitted for marketing approval.      Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two     long-acting bronchodilators as well as from monotherapy use of each of the long-acting     bronchodilators.      Methods: A series of population-based cohort studies, using both cohort and nested     case-control analyses will be conducted using data from the United Kingdom's Clinical     Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting     bronchodilators from Jan 2002 until Aug 2012, age >= 55 with chronic obstructive pulmonary     disease (COPD) and at least two years of baseline medical history information. The     high-dimensional propensity score technique will be used to match new users of each     long-acting bronchodilator and new users of two bronchodilators with comparable subjects from     the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke,     heart failure, arrhythmia and community acquired pneumonia. Data will be analysed using     time-dependent Cox proportional hazard regression models and conditional logistic regression     models.   "
90867|NCT02096718|"     The primary objective of the current study is to investigate the influence of moderate to     severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in     comparison to a control group with normal renal function.      The assessment of safety and tolerability will be an additional objective of this trial and     will be evaluated by descriptive statistics.   "
90871|NCT02096666|"     This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and     activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects     with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal     adenocarcinoma (Phase 2).   "
90872|NCT02096653|"     In this study, the investigators are attempting to determine whether intra- or     extra-articular injections are more effective; the relative prevalence rate of     intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular     injections using fluoroscopy as the reference standard. 124 consecutive patients with     mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3     positive provocative maneuvers will be randomized to receive SI joint injections by 2     different approaches.      Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive     landmark-guided injections into the tender area around the joint. In order to determine     whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be     done after the injection to ascertain the location of contrast spread. The primary outcome     measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be     followed at 3-months, while those who fail to obtain benefit will exit the study to receive     alternative care.   "
90873|NCT02096640|"     The main purpose of this study is to examine if there are differences in postoperative     inflammation following percutaneous dilatation tracheostomy versus surgical tracheostomy in     intensive care unit patients.   "
90874|NCT02096627|"     In this project, the investigators aim to compare the safety, efficacy, and predictability     outcomes of conventional CEIOL surgery to Femtosecond-laser-assisted CEIOL (FLACS) in an     effort to improve cataract surgery outcomes. The investigators hypothesis is that FLACS may     lead to preservation of endothelial cells compared to conventional CE IOL.   "
90875|NCT02096614|"     Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene     transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid     tumors.   "
90876|NCT02096601|"     An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/     infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if     continuous delivery of levodopa and carbidopa can provide reduced variability in plasma     concentration; to test and compare the PK profile of high and low concentrations of CD; to     assess preliminary efficacy.   "
90877|NCT02096588|"     Doxorubicin (Adriamycin), one of the drugs commonly used for the treatment of breast cancer,     is in a class of medications called anthracyclines. Anthracyclines may cause heart damage     that can lead to weakening of the heart muscle. This heart damage may happen right away or     may occur many years after the anthracycline is given.      Simvastatin is an oral medication approved by the FDA to lower cholesterol. Simvastatin is in     a class of medications called statins. Some research has shown that statins may prevent heart     damage that can be caused by anthracyclines like Doxorubicin (Adriamycin).      The purpose of this study is to determine if taking simvastatin while receiving the     chemotherapy Doxorubicin (Adriamycin) will minimize damage to the heart.      This study is for women who will be receiving the anthracycline doxorubicin (Adriamycin) as     part of their breast cancer treatment.   "
90878|NCT02096575|"     The purpose of this research is to study the effect of nitrous oxide on pain felt by women     having a surgical termination at less than 11 weeks compared to pain felt by women receiving     oral pain medications.   "
90879|NCT02096562|"     Outpatients who undergo knee surgery are designated two different clinical study groups.     Group A receives common wrapping after surgery to the first postsurgical day and will be     provided with compression stockings for the following 10 days, while group B only receives     common wrapping and will not be provided with compression stockings.      The investigators are going to investigate the effect of compression stockings on     postsurgical swelling and formation of edema on outpatients.   "
90903|NCT02096250|"     The government of Haiti plans to introduce a flour fortification program. The aim of the     project it to inform the authorities on the most suitable iron compound for this     fortification program. For this purpose, iron absorption from wheat flour using different     iron compounds will be investigated.   "
90880|NCT02096549|"     During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility     is essential to inject botulinum toxin to the right muscle. Because children with cerebral     palsy are generally unable to control their movement, deep sedation is required during this     painful procedure.      Short-acting drugs such as propofol and remifentanil are widely used for pediatric anesthesia     and sedation but still have possibility of over-sedation and associated complications due to     their rather narrow therapeutic window. Therefore, objective scoring system to assess the     level of sedation to provide an effective and safe sedation in children. Bispectral index     (BIS) monitoring,an objective guidance of sedation might be helpful.      The present study is to investigate the validity of the BIS monitoring during deep sedation     of children with cerebral palsy for injection of botulinum toxin.   "
90881|NCT02096536|"     Vancomycin is already used for decades in neonates. However, there are remaining questions     concerning vancomycin disposition in this population. The purpose of this study is first of     all to perform a paired analysis of serum vancomycin concentrations using an immunoassay     versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to     determine vancomycin protein binding and its covariates in neonates.   "
90882|NCT02096523|"     The goal of this study is to identify the platelet defect responsible for the bleeding in     families from our inherited platelet disorders Israeli-Palestinian registry. The     investigators plan to characterize platelet proteome expression after removing high abundance     proteins. The investigators will compare the proteome of sick and healthy members of families     with inherited platelet disorders, and identify and validate structural proteins, signaling     cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The     investigators expect to discover new key findings that allow better understanding of human     platelet function and allow better diagnosis and treatment of patients with inherited     platelet function disorders.   "
90883|NCT02096510|"     The aim of this study is to compare the effects of tablet treatment, circadian and combined     circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue     responses to therapy.   "
90885|NCT02096484|"     The study will examine the effectiveness of group metacognitive therapy in comparison with     group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be     randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy     sessions of their respective treatment condition.   "
90886|NCT02096471|"     This phase II open label study will evaluate adolescents (≥ 16 years of age) and adults with     neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor     PD-0325901. The primary aim of the study will be to assess quantitative radiographic response     in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2     mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects     will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses     beyond course 8 only if there is at least 15% reduction in volume of the target tumor.     Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses     can continue on therapy for up to an additional year (maximum of 24 total courses). However,     subjects who do not achieve at least 15% reduction in volume of the target tumor after 8     courses (~8 months) will be considered treatment failures and taken off study.      The Primary purpose of this protocol is to determine whether PD-0325901 results in objective     radiographic responses based on volumetric MRI measurements in adolescents and adults with     NF1 and growing or symptomatic inoperable PN.      There are several secondary aims of this protocol:      To evaluate the feasibility and toxicity of chronic PD-0325901 administration in this patient     population      To estimate the objective response rate of up to 2 non-target plexiform neurofibromas to     PD-0325901by MRI      To characterize the pharmacokinetic profile of PD-0325901 when administered to this patient     population      To characterize the pharmacodynamic profile of PD-0325901 when administered to this patient     population using dermal neurofibromas as a surrogate for plexiform neurofibroma cells      To characterize the activity of PD-0325901 on neurofibroma cell gene expression      To characterize the activity of PD-0325901 on plasma cytokines and growth factors      To correlate pERK levels to pharmacokinetic data and response      To evaluate quality of life and pain during treatment with PD-0325901      To validate the PedsQL NF1 QOL Module, a disease specific QOL scale, for use in this patient     population, and      To determine whether subjects who respond (≥20% objective radiographic response of target     lesion by 12 courses) to PD-0325901 will maintain that response for 1 year one they come off     therapy   "
90887|NCT02096458|"     The purpose of this study is to measure the in-vivo disintegration time of a single     dexlansoprazole delayed-release orally disintegrating (OD) tablet.   "
90888|NCT02096445|"     The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach     to train sensorimotor hand function after stroke. It combines the profound experience of the     clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and     training both the motor and the sensory system - with the advanced haptic robotic technology     of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich     (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual     objects with various mechanical properties. In a randomized controlled clinical trial, 10     sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated     seamlessly into their daily rehabilitation program, while 10 other patients will receive     conventional therapy. The investigators will assess baseline performance in an initial     clinical and robotic assessment, with another assessment at the end of the four-week period,     and in follow-ups four weeks and six months later. The contents of the patient-tailored     robotic therapy sessions will match those of the conventional therapy as closely as possible.     This study will demonstrate the feasibility of including robotic therapy of hand function     into the daily rehabilitation program, and investigate the acceptance from patients and     therapists. The investigators expect increased training intensity during the robotic therapy     session compared to conventional sessions with similar contents, as well as novel insights     into the recovery process of both the motor and the sensory system during the four weeks of     therapy, through advanced robotic assessments integrated into the training sessions. This     project is a first step towards making such robotic therapy available to patients as     integration into the conventional individual therapy program (e.g. for self-training), and     towards transferring this technology to the home environment.   "
90889|NCT02096432|"     This project aims to develop and refine a suicide intervention protocol, and pilot test a     culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese     older adults. During the first phase of the study, the investigators plan to invite the     community advisory board and key stakeholders to participate in the iterative design and     refinement of the study protocol. During the second phase of the project and after the     initial screening and based on a specific set of inclusion criteria, the investigators will     invite U.S. Chinese older adult to participate in a pilot randomized control trial of a     culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in     Chinese older adults. During the third phase of the project, the investigators plan to invite     pilot intervention participants as well as key stakeholders and health care professionals on     the cultural acceptability of the pilot intervention. Through the achievement of these     objectives, the investigators will set the foundation to fully test a culturally adapted     in-home intervention, which may be particularly suitable for Chinese older adults with     suicidal thoughts as it addresses cultural-specific barriers and integrates care management     within existing community services agencies using non-mental health professionals, including     community health workers.   "
93513|NCT02062060|"     Purpose of this study is to evaluate the efficacy of at-home administration of a single     application of abametapir lotion 0.74% w/w for the treatment of head lice.   "
90891|NCT02096406|"     Coronary artery disease is a leading cause of death, hospitalization, and health care costs     in developed nations. Coronary revascularization with coronary artery bypass graft (CABG)     surgery improves the long term survival in patients with diabetes and multi-vessel disease.     Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce     mortality and subsequent cardiac events in patients with coronary artery disease undergoing     CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have     suggested that pre-operative ACE administration is associated with an increased risk of     post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies     have failed to confirm these findings and further suggested ACE are associated with a reduced     risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized     to pre-operative ACE withdrawal or continuation reported that the withdrawal group required     significantly fewer vasopressors during cardiopulmonary bypass but more intravenous     vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs     should be held or continued immediately prior to CABG surgery and a survey of cardiac     surgeons suggests that current clinical practice is divided. This pilot study aims to     establish the feasibility of the study design and to determine the frequency of clinical     endpoints among patients who continue and discontinue ACE prior to cardiac surgery.   "
90892|NCT02096393|"     This is a randomised control trial to assess the benefits of using patient specific     instrumentation in total knee replacement surgery. Patient specific instrumentation is an     individualised system for total knee replacement surgery. The system has been marketed and is     already in use in some centres. The type of implant used remains the same but the sizing of     the components, and alignment of the implant is expected to improve. This study assesses any     improvement in implant alignment in using the patient specific instrumentation, any improved     intra-operative outcomes and any long term clinical outcome improvements for patients.   "
90944|NCT02095717|"     Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus     Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic     castration resistant. Assess time to progression (time to progression) of metastatic disease     (from first day of treatment in the trial).   "
90893|NCT02096380|"     Two Phase Ⅲ trials (TAX323 and TAX324) showed induction chemotherapy adding docetaxel to     cisplatin plus fluorouracil (TPF) could significant improve survival in head and neck cancer,     and a Phase Ⅱ trial from Hong Kong by Hui and colleges with this strategy has also been     reported in nasopharyngeal carcinoma (NPC). However, whether three cycles induction could     delay the whole time of treatment and reduce the survival benefit are still unknown. A     retrospective study of one cycle TPF induction chemotherapy by the investigators group (not     yet published) could improve survival in NPC. It encourage us to conduct this clinical trial.   "
90894|NCT02096367|"     Balance disorders are very common after strokes and often last for long periods of time.     Their origin is multifactorial and their impact on the daily lives of patients are     particularly important, especially on gait.      The vibration technology for rehabilitation was already studied in static posture with force     plats but their impact on gait have yet to be evaluated.      This present study aims at investigating the effects of vibrations applied by an approved     medical device to the posterior neck muscles and the gluteus medius - major actors of     proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during     the chronic phase after stroke.   "
90895|NCT02096354|"     This two-stage study is designed to compare the safety and activity between RRx-001 against     regorafenib followed by irinotecan-based therapies in a parallel comparative study.      Patients who are suffering from advanced or metastatic (meaning the disease has spread)     colorectal cancer are invited to participate in this study. There will be two groups of     patients (Randomized, open label study), one of these will receive RRx-001 and the other one     will receive regorafenib. If patients qualify to participate in this study, they will be     randomly assigned to the 'interventional arm' where patients will receive the experimental     drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care,     Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance     (1 out of 3) of receiving regorafenib.      On progression in the first part of the study, provided ECOG performance status is adequate,     and if clinically appropriate i.e. there are no absolute or relative contraindications in the     opinion of the Investigator, all subjects will enter the second part of the study and receive     irinotecan plus bevacizumab.      Whether patients are given RRx-001 or regorafenib, they will also receive best supportive     care, which includes treatments to help manage side effects and symptoms of cancer. This is     an open label study, which means patients will know to which of these treatments, RRx-001 or     regorafenib, they are assigned.   "
90896|NCT02096341|"     To investigate the dosage of RRx-001 by the subcutaneous route.   "
90897|NCT02096328|"     To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during     10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas     aeruginosa infection   "
90898|NCT02096315|"     To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis     bronchiectasis caused by Pseudomonas aeruginosa infection.   "
90899|NCT02096302|"     The purpose of this study is to determine whether an infant formula supplemented with a new     probiotic CECT7210, is effective in reducing the incidence of infections, specially the     gastrointestinal ones.   "
90900|NCT02096289|"     This is a Phase I trial investigating the safety of using thioridazine in addition to     cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.   "
90901|NCT02096276|"     The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes,     including teratogenicity, in females intentionally or unintentionally exposed to Boostrix     during their pregnancies. The Registry requires voluntary, prospective reporting of eligible     pregnancies by patients and health care providers (HCPs). Data such as vaccination with     Boostrix during pregnancy or within 28 days preceding conception, potential confounding     factors (such as exposure to other medications) and information related to the outcome of the     pregnancy will be collected prospectively.   "
93150|NCT02066831|"     The purpose of the study is to compare the effect of telemedical coaching versus telemedical     control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical     activity and quality of life in type 2 diabetes patients with poor glycaemic control.   "
90904|NCT02096237|"     In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with     a method, called immune apheresis, that removes IgE from blood. In order to achieve this     blood is taken continuously from the patient and then separated into plasma and blood cells     by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound.     The cleaned plasma re-joined with the blood cells is given back to the patient. In total     each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1     cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3     cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in     plasma/serum by at least 50% measured before the first treatment in the first cycle and after     the last treatment in the last treatment cycle. The new adsorber can be safely used in     patients. A group of patients with conventional drug treatment and no apheresis treatment     serves as control.   "
90905|NCT02096224|"     We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of     catheter-related bladder discomfort.   "
90906|NCT02096211|"     This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years)     information regarding the performance and safety of the commercially available 36mm CERAMAX®     Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not     previously involved in the IDE study for this device.   "
90907|NCT02096198|"     This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to     10-years) information regarding the performance and safety of the commercially available 36mm     CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were     previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component     that articulates with a ceramic femoral head in the COC total hip replacement system)   "
90979|NCT02095236|"     Radioopaque fiducial markers or electro-magnetic transponders will be implanted into or in     close proximity of the tumor. During a radiotherapy treatment session image and/or signal     acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging     or by specialized signal detectors The data will help to characterize tumor and organ motion     during one treatment session which may in fact have impact on dose distribution   "
90908|NCT02096185|"     Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where     this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to     assess that the abnormality has been removed and give an estimation of the distance from     lesion to specimen edge. This allows the surgeon to decide whether to remove more tissue or     not at the time. This study is designed to compare whether more accurate information about     lesion to margin measurement can be obtained using 3 dimensional tomosynthesis imaging     compared to 2 dimensional conventional digital imaging which is the type of imaging currently     used. This has the potential to prevent some patients requiring a second operation to remove     more tissue if the margins of the specimen are still involved with tumour.      The study involves x-raying the specimen under both conditions when it arrives from theatre.     Only the 2D image will be reviewed at the time as is current practice. The 3D image will be     reviewed later and the measurements for lesion to specimen margin compared. The lesion to     margin measurement as recorded by the pathologist will be taken as the 'gold standard' and     the imaging measurements will also be compared to that.      In theory, the use of 3D tomosynthesis should allow more accurate lesion to margin     measurement because 3D can provide better visualisation of the lesion edges by removing the     effect of superimposed tissue.      The hypothesis states that the use of 3 dimensional tomosynthesis imaging should provide     better lesion visualisation compared to 2 dimensional conventional digital imaging thus     allowing more accurate lesion to margin measurement.   "
90909|NCT02096172|"     The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug     metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).   "
90910|NCT02096159|"     The primary purpose of this study is to determine if routine use of prophylactic (preventive)     antibiotics after repair of mid-to-distal hypospadias is beneficial.   "
90911|NCT02096146|"     This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first     tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly     assigned to one of these two treatment options.   "
90912|NCT02096133|"     Patients with multiple sclerosis (MS) have an increased risk of developing a major     depression. The investigators observed a protective effect of high vitamin D levels on the     risk of depression in MS. This might be driven by the effect of vitamin D on the stress-axis.     Therefore, the main goal of the present study is to assess whether high dose vitamin D     supplementation results in a suppression of the stress-axis, as measured by decreased levels     of cortisol.   "
90913|NCT02096120|"     The purpose of this study is to determine whether full mouth disinfection in combination with     one week antibiotic amoxicillin plus metronidazole antibiotic therapy is improving     periodontitis and disease activity of rheumatoid arthritis.   "
90914|NCT02096107|"     Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids     in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone     will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.   "
90915|NCT02096094|"     Traditional bed bathing have been related to cross-infection. In order to avoid this     complication, single-use products such as wipes impregnated with chlorhexidine use is     increasing. Nevertheless among nursery staff concern about its side effects prevents its     widespread use. The investigators want to know if there are any differences between the use     of 2% chlorhexidine wipes and a placebo concerning side effects.   "
90916|NCT02096081|"     The purpose of this study is to show that two FDA-approved botulinum toxin drugs called     Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between     the eyebrows (glabellar frown lines).   "
90917|NCT02096068|"     The drug Dexmedetomidine will be investigated in 72 patients (men and women) undergoing     elective cardiac or abdominal surgery. The study medication will be administered     perioperatively by intravenous infusion continuously (at the longest 48 h) to prevent/reduce     the rate of Delirium and the incidence of postoperative cognitive deficit (POCD).      A non-surgical control group of 15 ASA II/III- patients from Berlin and surrounding area is     collected for measuring the learning experience during the cognitive testings. The     participants are matched on age, education, and gender to the study patients.      Cognitive testings are performed in patients of the study group (n= 72) and the control group     (n= 15) to evaluate deficits in their cognitive areas (POCD (Postoperative cognitive     deficit)) at three different time points up to three months.   "
90919|NCT02096042|"     This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2.      The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab     vedotin to patients with AML. The goal of Phase 1 is to learn more about the safety of the     combination of brentuximab vedotin with azacytidine. The goal of Phase 2 is to learn if the     combination of brentuximab vedotin and azacytidine can help to control AML.   "
90920|NCT02096029|"     The purpose of this study is to evaluate the use of sampling of smoking cessation     medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half     of study participants will be provided with samples of medication, to use however they wish;     the other half will not be provided with these samples. All smokers will be advised to quit     through routine contact with their physician. After the primary care contact, all     participants will be contacted by phone for three brief follow-up interviews, which will     involve answering questionnaires about their smoking habits.   "
90921|NCT02096016|"     The investigators have planned this project to evaluate the follow-up program after surgery     due to cervical cancer and to explore the possibilities for different tests of Human     Papilloma Virus (HPV) in contributing to the customization of the follow-up program.      Purpose:      The investigators effort is to provide the background for an evidence-based update of the     follow-up program after surgery due to cervical cancer with the purpose of early diagnosis of     recurrence affecting quality of life for as few women as possible.   "
90945|NCT02095704|"     Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an     orally administered solid dosage form. The aim of this study was to evaluate the     pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese     healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters,     investigators trend to propose a method to estimate in vivo dissolution time and dissolution     kinetics of solid dosage form.   "
90922|NCT02096003|"     The use of intrathecal opioids for analgesia in the setting of cesarean section has become     standard obstetric anesthesia practice. Currently, two opioids are commonly used. These     opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of     analgesia and act to reduce the stress response to surgery.      Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after     cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use     of this medication is associated with side effects such as pruritus and nausea and vomiting.      Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for     cesarean delivery when morphine was unavailable. As groups began to use hydromorphone,     retrospective data became available that demonstrated its safety and efficacy for use during     cesarean section.      In order to fully elucidate the analgesic and side effect properties of hydromorphone for     cesarean delivery, a prospective randomized, double blind study comparing morphine and     hydromorphone is necessary. The investigators need to understand whether hydromorphone is as     effective as morphine for analgesia after cesarean section, and whether it is associated with     fewer or more side effects. The results of the study will allow providers to make educated     decisions to better care for their patient.   "
90923|NCT02095990|"     To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce     melasma on the face, using a split-face randomization design, evaluating the MASI Score from     baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.      To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the     face.      To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.   "
90924|NCT02095977|"     A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE)     database, which contains reports of adverse events involving medical devices6,9. The FDA     updates the database every two months. A total of 107 Riata leads with reported inside-out     insulation breaks were found, of which 105 were available for analysis. The average age of     the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143     inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out     insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23     were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32     leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22     of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor.     Noise and other sensing issues were the most common signs of failure. Seven leads were found     to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%)     experienced inappropriate shocks of which 41% had abraded cables.      A critical decision facing physicians is how to screen and manage patients who are found to     have externalized cables. Externalized cables on fluoroscopy may precede any electrical     abnormalities. Also noise may not be detected on all ICD models. A recent case report     suggested that changes in lead parameters might be transient and may be missed. The lead may     function normally as the high-voltage and pace-sense cables are covered with ETFE, which     serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the     reliability of this to withstand a high-energy shock is unknown. This may lead to failure of     appropriate therapy for life threatening arrhythmias.      The aim of this study is to screen patients with ICD leads that potentially could have     multiple different failure mechanisms, including inside-out insulation breaks, to develop a     novel new algorithm and methods to detect these defects, thereby enabling physicians to     prevent complications from failure of these leads.      It is hypothesized that current monitoring tools are insufficient for detecting the sometimes     transient electrical failures of the Riata family of leads, and that additional device     diagnostic information in combination with fluoroscopy may improve detection of electrical     failures.   "
90925|NCT02095964|"     High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse     cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial     generation of nitric oxide (NO) and improves endothelial function and arterial     vasoreactivity[11]. In several studies, lower HDL-C level was reported to be associated with     increased coronary artery disease (CAD) risk[12-14]. HDL-C also has anti- inflammatory and     anti-oxidant activities[15,16]. Concerning anti-inflammatory activity, HDL-C inhibits the     activation of monocytes/macrophages and neutrophils[17,18] and inhibits the expression of     endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and     E-selectin[15].      In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory     markers in patients with cardiac syndrome X (CSX).   "
90940|NCT02095769|"     The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx)     Testing for elderly and disabled patients can help physicians manage patient medication     regimens and assess if the testing has an effect on reducing adverse drug events,     hospitalizations, and emergency department visits.      The way an individual processes or metabolizes a drug is in part determined by their genes,     and there is known to be genetic variation from one human to another. The study of the way in     which genes affect an individual's response to drugs is known as Pharmacogenomics.   "
90941|NCT02095756|"     The purpose of this study is to evaluate the efficacy and safety of a combination of     non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone     for the treatment of facial melasma.   "
90987|NCT02095132|"     This phase I/II trial studies the side effects and best dose of WEE1 inhibitor MK-1775 and     irinotecan hydrochloride in treating younger patients with solid tumors that have come back     or that have not responded to standard therapy. WEE1 inhibitor MK-1775 and irinotecan     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
90926|NCT02095951|"     The study team will compare hospital length of stay (LOS) and attributable length of stay     (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing     short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for     up to 72 hours) placed within 24 hours of admission(Group 1, Preemptive ELT) versus ELT     placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of     Care ). ELT will be given in both groups, in combination with systemic antibiotics, for the     treatment of CRI (suspected or proven) of the blood in children with central catheters.     Participants will be enrolled from patients with hematologic/oncologic disorders and bone     marrow or hematopoetic stem cell transplants (BMT) admitted for care to Children's Hospital     of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be     defined as the number of hospital days between first symptoms of Catheter-related infection     (CRI) (or date of admission for those admitted with symptoms) and first negative blood     culture.      Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined     above, placed within 24 hours of symptoms/admission (Arm 1) versus ELT placement at the time     of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for     the treatment of CRI (suspected or proven) of the blood in children with central catheters in     the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable LOS     (ALOS) and therefore lower hospital costs.   "
90927|NCT02095938|"     1. Study rationale - Nielsen et al reported that after 6 weeks of amisulpride treatment,          patients with schizophrenia showed an increase in the anticipation-related functional          MRI signal. This suggested that amisulpride could affect the brain structures and that          responses to amisulpride could be associated by the brain structures as seen previous          studies about treatment response to antipsychotics and brain structures. But to date, no          study has examined the impact of brain structure alterations on amisulpride treatment          for schizophrenia and its potential clinical significance.        2. Study Objectives 2-1. Primary: To show the differences of the baseline brain structures          on the structural MRI between the Solian® treatment responders and the non-responders          2-2. Secondary: To show the differences of the baseline polymorphisms of COMT and BDNF          with molecular genetic analysis between the Solian® treatment responders and the          non-responders responder defined by PANSS. To find out the correlates of baseline brain          structures with symptom severity of schizophrenia at baseline; symptom severity defined          by CGI-S and PANSS. To assess psychotic symptom improvement after 8th week of Solian®          treatment using PANSS, SANS, SAPS and CGI. To assess safety after 8th week of Solian®          treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs. To report          all serious adverse event within 24hrs regardless of relationship to investigational          product.        3. Study Design: Prospective/ Open label/ Interventional/ Controlled        4. Evaluation Criteria:      5-1. Primary endpoints: Brain structures on the structural MRI will be observed before the     treatment starts. Based on the clinical response after treatment, patients will be divided in     the two different groups as follow and their baseline brain structure of will be compared.     Treatment responders and non-responders.      5-2. Secondary endpoints: The relationship of baseline brain structures with symptom severity     of schizophrenia. Severity will be determined by CGI-S and PANSS at baseline. The differences     of the polymorphisms of COMT and BDNF with molecular genetic analysis using patients'     peripheral blood, especially leukocytes, between the treatment responders and the     non-responders. Efficacy - PANSS, SANS, SAPS, CGI. Safety - Barnes akathisia scale,     Simpson-Angus scale, Vital signs   "
90928|NCT02095925|"     Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism,     collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer     patients have been previously developed by the groups of Khorana and Vienna CATS. However,     routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently     not recommended. In the investigators prospective, observational cohort study, the     investigators aim to identify cancer patients at high risk for VTE based on clinical     characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing     microparticles.   "
90929|NCT02095912|"     To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ     transplant recipients.   "
90930|NCT02095899|"     The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain     in patients with a post thoracotomy pain syndrome.   "
90931|NCT02095886|"     The purpose of this study is to select the best dose level (amount of drug given) and best     formulation of the study drug (BMS-955176) to develop further.   "
90932|NCT02095873|"     The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are     effective in improving metabolic and vascular health.   "
90933|NCT02095860|"     The purpose of this study is to assess the effect of a high fat meal and light meal on the     blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs     as a fixed-dose combination in healthy subjects.   "
90934|NCT02095847|"     The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can     be used to help guide tumor removal during a hysterectomy.   "
90935|NCT02095834|"     The goal of this clinical research study is to find the highest tolerable dose of carfilzomib     when given in combination with bendamustine and dexamethasone. The safety of this drug     combination will also be studied.   "
90936|NCT02095821|"     Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as     humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily     measured fibrinogen blood levels to prevent bleeding complications. However, data about the     correlation of fibrinogen blood levels and function of the coagulation system during plasma     exchange therapy is scarce. In the present study we examine blood fibrinogen levels and     coagulation factors as well as thrombin clotting time in patients under plasma exchange     therapy.   "
90937|NCT02095808|"     The purpose of this research study is to develop a method of using magnetic resonance imaging     (MRI) to evaluate solitary pulmonary nodules (mass in the lung smaller than 3 centimeters). A     pulmonary nodule is a mass or growth on the lung. An MRI is a scanning device that uses     magnets to make images (pictures) of the body. This study is being done to determine what     series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for     growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being     investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying     a small sample of the tumor once it is removed at the time of surgery.   "
90938|NCT02095795|"     The main objective of the present study was to compare the effects of exoskeleton devices     used in electromechanical-assisted gait training after stroke compared to over ground     conventional physical therapy in a single blind research.      The second objective is to research when the devices can be used with the best chance of     success in the functional recovery of gait in people who are unable to walk independently     after stroke.   "
90939|NCT02095782|"     This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of     intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and erlotinib     on patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR     mutation.   "
90984|NCT02095171|"     This single ascending dose study is to determine safety, tolerability, pharmacokinetics and     immunogenicity of PRX002 in approximately 40 healthy subjects.   "
90942|NCT02095743|"     Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in     case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its     toxicity toward veins, chemotherapy must be administered through a central venous device.     Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central     Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week     and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port     is subcutaneous and lets patients lead a normal life, but its implant and explant require a     cutaneous incision with possible complications (bleeding, pain, infection). For both venous     devices, complications such as thrombosis or infection may happen. Published data comparing     the two devices are heterogeneous and do not often distinguish patients treated for different     diseases at various stages. Empirically in daily practice, for long term use (>6 months) a     port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used.     In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5     months. There is no scientific evidence for preferring one device to the other for these     patients.      The aim of this study is to prospectively compare the patients' satisfaction and tolerance of     each of the two devices.   "
90943|NCT02095730|"     The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in     a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.   "
90947|NCT02095678|"     The primary objective of this study is to develop and validate simultaneous free-breathing 4D     fat and water quantification and quantitative dynamic contrast enhanced perfusion in the     liver. Secondary aims include developing and validating free breathing quantification of     relaxation parameters T1 and T2, and developing and validating a minimal breath-hold (< 8 s)     high quality diffusion exam using highly accelerated steady state diffusion imaging     sequences. Investigators aim to scan 100 subjects receiving liver biopsies as a part of their     standard care and another 70 subjects with known benign lesions. The study is greater than     minimal risk.   "
90948|NCT02095665|"     Ureteric stents are used often following ureteroscopy for prevention of obstruction from     edema and or stone fragments. They are often associated with pain, voiding often, the need to     urinate quickly and finding blood in the urine called lower urinary tract symptoms or LUTS     for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin     in relieving stent symptoms (pain and LUTS). There is emerging but limited evidence to show     that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in     decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms.      Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in     treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side     effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit     their use in some populations. Mirabegron is well-tolerated with a good safety profile and     therefore may be useful in treating stent symptoms without the bothersome side effects     commonly seen with antimuscarinic medications. .      The investigators hypothesize that mirabegron is effective in decreasing ureteral stent     related LUTS and pain.   "
90949|NCT02095639|"     The purpose of this study is to explore whether electroconvulsive therapy (ECT) accidentally     leads to a side effect of brain inflammation. Patients with treatment resistant depression     who are planning to take ECT will be subsequently approached to participate in the study.   "
90950|NCT02095626|"     The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary     graft dysfunction after lung transplantation.   "
90951|NCT02095613|"     The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti     (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life     outcomes when compared to a second type of food supplement (corn-soy-blend) over the course     of 12 months of food supplementation.   "
90952|NCT02095600|"     Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known     procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually     achieved using stereotactic surgical procedures.      Radiosurgery of invisible targets to treat movement disorders and intractable pain are still     the domain of frame-based procedures, due to the need of a solid reference system registered     to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of     stereotactic atlases.      In this study we want to utilize a mathematical method that uses atlas-derived stereotactic     coordinates to perform frameless images-guided radiosurgery of such functional targets     Particularly the aim of the present study is to investigate both the efficacy and the safety     of the methodology to treat upper limb and hand tremor in elderly or in patients which are     not ot susceptible of surgical procedures. For these reasons a dose escalation prospective     trial have been designed.   "
90953|NCT02095587|"     To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to     subjects with chronic hepatic impairment and in matched healthy subjects.   "
90954|NCT02095574|"     A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with     Non-Hodgkin's Lymphoma.   "
90955|NCT02095561|"     Cervical cancer is a leading cause of mortality among women in developing countries. A key     factor has been the failure to achieve good coverage. The development in the last years of     HPV-DNA based tests has changed the scenario, because it combines a high performance to     detect disease with a reduction of screening frequency. Through self-testing, HPV testing has     the potential of reducing social and health service barriers faced by women to access     screening.      This study is carried out in Jujuy, one of the Argentinian provinces with highest cervical     cancer mortality rates and where HPV testing has been introduced as a primary screening test     for all women attending public health sector. The study was conducted between July     2012-December 2013, and supported by the Argentinean National Cancer Institute. The protocol     was approved by the institutional review committees of the Ministry of Health of Jujuy.      This trial is a randomized by population clusters study that aims to assess the effectiveness     of self-testing to increase coverage. The aims of this study are: a) to assess the self-test     effectiveness to increase the participation of women in screening programs, b) to assess the     self-test acceptability by women, c) to assess HPV self-test effectiveness measurement for     the detection of CIN2+ lesions against cytology in primary screening.      An overall number of 200 community health workers (CHWs) from the Primary Health Care System     (PHCS) of Jujuy will be randomized into two groups that will be named Self-test Group (ST)     and Conventional Sample Group (CS):        1. ST Group: CHWs will invite eligible women of their area to choose between doing a          self-test or having a conventional sample taken by a health professional of the closest          health care center.        2. CS Group: CHWs will invite eligible women in their area to have a conventional sample          taken by a health care professional of the nearest health care center.      In order to measure the self-test relative sensitivity against cytology to detect CIN2+ in     primary screening, all the women in the Self-test Group who have decided to do the self-test     and all the women of 30 years of age and older that were screened with cytology by the     provincial program for the prevention of cervical cancer in 2011 will be considered.      A database built specifically for the study will be used; it will hold the list of eligible     women to participate in the study. The records of women of 30 years of age and older residing     in the areas included in the study will be imported from the PHCS databases.      In addition, the data surveyed by the study will be uploaded: randomization Group, presence     of the woman at home during the CHW's visit, agreement to participate in the study,     realization of self-test (in the corresponding group), and if appropriate, reasons for not     doing the self-test. Lastly, the HPV Test realization will be uploaded importing the data on     SITAM, (link of data done as from the identity card number).      Data Analysis      Self-test acceptability: Acceptability is defined as the number of women accepting the     self-test against the number of women offered the option between the self-test and the     conventional sample (proportion of women accepting the self-test). The acceptability in this     population will be estimated as the average of acceptabilities calculated by CHW, as to     control the impact of the CHWs on acceptability and reach an appropriate variance estimate.     Besides, the variability introduced by the CHWs on acceptability will be studied and the     results obtained by male and female CHWs will be compared, as well as those obtained by the     CHWs in rural and urban areas.      Self-test effectiveness to enhance participation of women in screening and diagnosis: There     will be a comparison of the percentage of women that did the HPV test in the Self-test group     and the Conventional sample group. Three different coverage indicators will be considered for     every CHW. These will be defined as the number of women screened within the field work     regarding:        1. The number of women reached by the CHW who accepted participating in the study.        2. The number of eligible women for that CHW (regardless of whether the CHW was able to          contact them or not).      The effect of the strategy (offering the self-test option against promotion of the     conventional sample) will be estimated for each one of the coverage measures using a means     difference test or a non-parametric test for independent samples.      CIN 2+ detection rate: The effectiveness of the HPV Self-test against screening cytology to     detect CIN2+ will be estimated as the detection rates difference and as the detection rates     ratio. In addition, there will be a comparison of the CIN2+ detection rate in the group of     women who did the self-test against the total number of women in the province of Jujuy that     were tested for HPV (conventional sample strategy + triage Pap test) until December 2012.   "
90956|NCT02095548|"     The purpose of this study is to find the optimal dose of SM04690 that can be safely given by     intra-articular injection into the target knee joint of subjects with moderate to severe     osteoarthritis.   "
90957|NCT02095535|"     Before a patient gets a spinal/epidural, their lower back is cleaned with an antiseptic     solution diluted in alcohol called ChloraPrep. ChloraPrep must completely dry before starting     the anesthetic procedure. It is not known how much time is needed for the solution to     completely dry. The investigators aim to determine this.      As the ChloraPrep dries, the alcohol is converted into vapour. The investigators will be     using a PPBRae 3000 device to detect small amounts of vapours in the air. As the ChloraPrep     dries it gives off less and less vapour. The investigators will use this diminishing vapour     concentration to determine when drying is complete.   "
90958|NCT02095522|"     Colchicine has antiinflammatory properties. It has been shown to be effective in improving     outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to     assess the effect of colchicine on endothelial function using the EndoPAT™ in NSTEMI     Patients.      Study Hypothesis: There will be a significant difference on the RH-PAT levels of the patients     who were in treated with colchicine versus the placebo group Study design and patient     Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial     Infarction will be enrolled to a prospective randomized double-blind placebo controlled study     in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their     hospitalization before cardiac catheterization. All patients will sign an informed consent.      Primary outcome will be the improvement in endothelial function between baseline and after 1     month in both groups   "
90959|NCT02095509|"     To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically     ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered     either as a continuous intravenous infusion or subcutaneous bolus once daily.      To investigate possible ongoing coagulation by coagulation markers during antithrombotic     therapy with standard doses of enoxaparin   "
90960|NCT02095496|"     Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known     factor in this deterioration.The investigators hypothesize that close-loop ventilation mode     (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the     patient needs.   "
90961|NCT02095470|"     new glidoscope was tested on 401 patients   "
92103|NCT02080507|"     The purpose of this study is to determine the safety and efficacy of rTMS as an alternative     treatment to ECT. The study will also provide data for a power analysis to support a larger     clinical trial if there is evidence of a clinically relevant treatment effect.   "
90962|NCT02095457|"     Scientific Background: Inherent gaps exist between the worlds of research and clinical     therapy, especially in mental-health systems. Developed as an important strategy aimed to     bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a     method devised for systematic ongoing quantitative measurements used in diverse clinical     practices, from psychotherapies to psychiatric management. The efficacy of this approach has     been repeatedly demonstrated in various measures, such as satisfaction with treatment by     patients and therapists, lower drop-out rates, symptomatic benefits, and more.      Objectives: The aim of the current study is to test the feasibility and the clinical benefits     of implementation of a Routine Outcome Monitoring System in a public clinical center, as a     pioneering project in Israel, at the Shalvata Mental Health Center.      Working Hypotheses: Incorporation of a ROM system in routine clinical practice is     hypothesized to improve patients' and therapists' overall satisfaction, allow for early     detection and intervention in therapeutic raptures, decrease drop-out rates, and improve     various clinical outcome measures.      Methods: The suggested study is a two-stage (implementation and intervention) open trial. 900     new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention (ROM)     and control groups. Assessment questionnaires will be filled periodically using 'CORE-NET', a     computerized system enabling repeated measurements and feedback in a user-friendly and     efficient manner.      Data Analysis: The evaluation of the differential influence of monitoring processes on     overall efficiency as compared to control group will be tested using Multiple Analysis of     Variance (MANOVA). The predictive value of possible variables on process and outcome of     therapy will be assessed using stratified regression analyses. The possible causal effects     between specific lagged variables will be assessed using Hierarchical Linear Modeling and     Time Series Analysis.      Contribution: This pioneering study is the first in Israel to offer a routine systematic     evaluation of therapeutic processes, as well as assessing its clinical effects. Consequently,     a large and meaningful data-set will emerge, enabling significant enrichment of our     evidence-based understanding of therapeutic processes.   "
90963|NCT02095444|"     The purpose of this study is to determine whether human menstrual blood-derived stem cells     are effective in the treatment of infection of H7N9 virus caused acute lung injury.   "
90964|NCT02095431|"     Acute kidney injury (AKI), is a common complication of patients undergoing liver     transplantation. Timing and definition of AKI, usually based on serum creatinine, have been     inaccurate and inconsistent.      We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to     provide information on the risk of progression of AKI, the need for RRT and mortality.   "
90965|NCT02095418|"     With improvements in patient and graft survival, increasing attention has been placed on     complications that contribute to long-term patient morbidity and mortality. New-onset     diabetes after transplantation (NODAT) is a common complication of solid-organ     transplantation, and is a strong predictor of graft failure and cardiovascular mortality in     the transplant population. Risk factors for NODAT in transplant recipients are similar to     those in non-transplant patients, but transplant-specific risk factors such as hepatitis C     (HCV) infection, corticosteroids and calcineurin inhibitors play a dominant role in NODAT     pathogenesis. The predominant factor for causing NODAT by corticosteroids seems to be the     aggravation of insulin resistance; however several studies have displayed deleterious effects     on insulin secretion and β-cells. Thus, adjusting the immunosuppressant regimen to improve     glucose tolerance must be measured and defined from long term perspective.      As recipients of organ transplants survive longer, the complications of NODAT have assumed     greater importance; therefore, we designed a prospective study to compare the safety and     efficacy of early versus late withdrawal of corticosteroids after liver transplantation.   "
90966|NCT02095405|"     Stimulants and drugs are often associated with cardiac effects. Caffeine, a therapeutic     xanthine, has been described as a sympathomimetic and has shown to have stimulatory effects     on the heart. Patients with symptomatic cardiac arrhythmias are generally informed by their     physician to stop or significantly reduce caffeine intake. However, in spite of numerous     reports that have reviewed the cardiac effects of caffeine, it remains unclear to what extent     this stimulant may be detrimental, and what subgroups of patients may be most vulnerable. The     investigators propose to evaluate the effects of caffeine in patients with previously     diagnosed cardiac arrhythmias. The results of our report will provide important new     information for physicians and patients regarding the effects of caffeine on symptomatic     cardiac arrhythmias.   "
90967|NCT02095392|"     The study was conducted to investigate the effect of soluble phosphate in combination with     different calcium doses on calcium and phosphorus metabolism and further physiological     parameters in healthy subjects. The main aim of the study is to investigate the influence of     a soluble phosphate supplementation on the fasting blood phosphate concentration and the     dependency of an additional calcium intake.   "
90968|NCT02095379|"     In this study, the investigators aim to investigate the prevalence and clinical course of     oligosecretary myeloma.   "
90969|NCT02095366|"     Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute     traumatic pain in prehospital and Emergency departments (ED).      The investigators hypothesize that IN administration of Sufentanil is equal as compared with     Intra veinous (IV) administration of Morphine wich is widely recommended in ED.      The investigators study is a multicentric, comparative, randomized, double-blind,     double-placebo study, comparing quality of analgesia in both groups 30 minutes after first     administration of opiates.      The investigators also asses side effects and patient satisfaction in both groups.   "
90970|NCT02095353|"     The investigators propose to analyze the perfusion (blood flow) characteristics of blood     tumors. The investigators will be comparing the use of two contrast agents in this study.   "
90971|NCT02095340|"     The purpose of this study is to expand our understanding of the intergenerational     transmission of cognitive risk for childhood anxiety disorders by examining whether changes     in maternal interpretations of situations result in changes in child interpretations and     child anxiety.   "
90972|NCT02095327|"     The purpose of our study is to better understand how caregivers of individuals with dementia     cope with their family member's illness. If you are eligible for the study and would like to     participate, we will schedule a one-time phone interview, which will last approximately 2     hours for which you will be compensated for your time.   "
90973|NCT02095314|"     Measure antibody persistence prior to booster administration of Pentabio vaccine.   "
90974|NCT02095301|"     The objective of this study is to assess the effects of an herbal extract on mental energy in     healthy human subjects.   "
91007|NCT02094872|"     This phase II trial studies how well molecularly targeted therapy works in treating patients     with melanoma that has spread to other parts of the body. Patients must have received or do     not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs     or other substances to identify and attack specific types of cancer cells with less harm to     normal cells. Molecularly targeted therapy works by treating patients with substances that     kill cancer cells by targeting key molecules involved in cancer cell growth.   "
90975|NCT02095288|"     Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated     interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target.     Global deletion of mPGES-1 in mice suppresses PGE2 and augments PGI2 by PGH2 substrate     rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not cause a     predisposition to thrombogenesis and hypertension. However, cell-specific deletion of mPGES-1     reveals that the predominant substrate rediversion product amongst the prostaglandins varies     by cell type, complicating drug development. We have developed an ultra performance liquid     chromatography/ tandem mass spectrometry (UPLC-MS/MS) technique that allows the     quantification of a wide range of lipids beyond the prostaglandin pathway (leukotrienes,     anandamide and the 2-arachidonylglycerol cascades).      This study is designed to examine different pathway interventions from the arachidonic acid     cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human     blood in vitro (Part A) and ex vivo (Part B). In Part A, whole human blood will be donated by     healthy volunteers and treated with screening compounds in vitro (outside of the body).     Experiments will be performed to measure an array of lipids in plasma and serum from     pre-stimulated whole blood treated with a single or a combination of the test compounds.      This study may reveal pathways previously unknown to be affected by the existing     anti-inflammatory drugs and drug candidates, and will possibly suggest new indications and/or     side effects.   "
90976|NCT02095275|"     B-type natriuretic peptide (BNP) is rapidly released by the ventricles of the heart in     response to myocardial stretch. This cardiac neurohormone is mostly elevated in patients with     fluid overload or myocardium dysfunction. BNP is a very useful and important marker. It can     predict mortality and cardiac events in patients in the ICU setting. In stable hemodialysis     patients with normal LV function on echocardiography, high BNP levels are likely the result     of blood volume expansion and require reduction in postdialysis dry weight.      In the past, there were many methods to evaluate fluid status. Some are not reliable such as     central venous pressure or physical examination. Some are invasive and expensive such as Swan     Ganz、PiCCO catheter or bioimpedance device. Nevertheless, About the relationship between BNP     and fluid status, a study found a significant relation between bioimpedance-derived body     composition (BC) (fluid distribution) parameters and BNP concentrations. This relationship     was independent of the cardiac history of the patient and suggests that the natriuretic     peptide levels are to some degree modifiable by changing a patient's fluid distribution.      In this study, the investigators want to observe that if the level of BNP can predict the     occurrence of acute kidney injury and the need of renal replacement therapy. Besides, the     investigators also want to see if BNP can be a useful and convenient marker to guide     adjustment of optimal fluid status and then to improve outcome.   "
90977|NCT02095262|"     Tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there     being no such sound in the external world. It is prevalent and for many individual is a     distressing condition. Recent advances in the understanding of changes in the hearing brain     and their relation to tinnitus perception has led to a focus on forms of active auditory     training which might provide effective techniques for tinnitus management. Our recent trial     of auditory training provided evidence that training using sounds where there is no hearing     loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there is     some level of hearing loss. Our next challenge is to build on this finding in ways that might     maximize the benefits we observe.      The training software we used previously was developed for use with children. Past     participants have given mixed reviews of this software. While some enjoyed the training or     found it soporific, others reported that they found it too monotonous and un-motivating. We     therefore wish to explore the impact of different game mechanics in the delivery of auditory     training and have designed two different interactive games in the context of training for     tinnitus benefit. These games will deliver the same type of auditory training as the software     we currently use, but should be intrinsically motivating, i.e. be a game that the people are     motivated to play irrespective of any potential benefit for tinnitus. The game we previously     used is reactive, i.e. the sounds play and the player selects what they think is the correct     answer (odd one out).      The two new games we wish to test can be described as interactive, i.e. players control the     sound delivery and actively seek the correct answer: this may have additional benefit for     tinnitus.   "
90985|NCT02095158|"     This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride     (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.   "
90986|NCT02095145|"     This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in     patients with prostate cancer that is limited to a certain part of the body (localized), who     have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow     disease progression in patients with localized prostate cancer.   "
90978|NCT02095249|"     Prostate cancer is the most commonly diagnosed form of cancer in Canadian men. In 2006,     greater than 250,000 men were diagnosed with prostate cancer in the United States and Canada     with more than 32,000 men dying of their disease. Using the prognostic variables of     T-category, the serum prostate specific antigen (PSA), and the pathologic Gleason score (GS),     men with localized prostate cancer are placed in low, intermediate and high-risk groupings.     Usually this is treated with surgery, radiation therapy, hormone therapy and/or watchful     waiting (also known as active surveillance). While these treatments are quite effective,     tumours are likely to recur in about 40% of cases. There is a need for additional prostate     cancer treatments. To address this need, many experimental therapies are being developed and     tested in mice with prostate tumors. This includes the study of aggressive prostate cancer     cells such as stem cells, or Tumour Initiating Cells (TICs), or oxygen deprived cells, which     may be the ones most likely to re-grow into a tumour or spread throughout the body.     Researchers want to try and isolate these special cells from the prostate after surgery to     study their features, and to see if they can re-grow as solid tumours in mice. Researchers     would like to test whether the prostate cancer stem cells are more resistant or less     resistant to treatments. This will allow researchers to study and test new treatments that     specifically target resistant and aggressive prostate cancer cells. The investigators     hypothesize that marker-defined TIC cells or hypoxic cancer cells have unique genetics in     primary prostate cancers and are relatively chemo- and radio-resistant.   "
90980|NCT02095223|"     Muscle inhibition prevents optimal contraction of the quadriceps muscle due to changes in the     nervous system after knee joint injury. Current treatments for muscle inhibition at this time     include knee joint cryotherapy and electric stimulation prior to exercise. These treatments,     in addition to strengthening exercises, have shown improvements in the quality and strength     of muscle contractions however, they have a short window of effectiveness. Electromyographic     Biofeedback is proven to be useful in improving quadriceps strength but the mechanism of     action remains somewhat unclear. Therefore, the purpose of this investigation is to compare     the effectiveness of electromyographic biofeedback supplemented exercise when compared to     traditional exercise on quadriceps muscle function in individuals with a history of knee     injury and current evidence of quadriceps inhibition. We hypothesize that 14 days of     electromyographic biofeedback supplemented exercise will lead to larger gains in quadriceps     activation when compared to traditional exercise.      Thirty 18-40 year old participants with a history of knee injury and current evidence of     quadriceps muscle inhibition will be enrolled in this single blind randomized controlled     trial. Participants will provide written consent prior to all study procedures. Following     enrollment, participants will be asked complete questionnaires related to knee related     function, current levels of pain, and current activity level followed by completion of     baseline measurements.        1. We will use the superimposed burst technique to quadriceps muscle activation.        2. We will measure the Hoffmann reflex response of the quadriceps with surface          electromyography. We will measure this signal with surface electromyography electrodes          that record the activity of the quadriceps muscle through the skin.      Participants in both groups will be instructed on a 14 day home exercise protocol on the day     of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing     and weight bearing quadriceps strengthening. Compliance will be monitored via a daily     exercise diary which will be collected at the end of the study protocol.      Quadriceps central activation ratio, active motor threshold and Hoffmann reflex will be     reported descriptively. Pre-intervention and post 14 day intervention quadriceps central     activation ratio and Hoffmann reflex will be compared between traditional exercise and     Biofeedback supplemented exercise   "
90981|NCT02095210|"     This is an open-labeled, exploratory, single center study. Patients with a big primary breast     cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by     biopsy. Patients having a HER2-positive tumor will be recruited to the study. A [18F]FDG     PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of     possible metastases. Each subject will receive a single injection of the investigational     product [68Ga]ABY-025, followed by measurement of uptake in the tumour or metastases and in     normal organs. The investigations will be repeated after HER2 directed therapy.   "
90982|NCT02095197|"     Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per     year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or     foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck,     scapula or arm. The diagnosis of radicular pain is made clinically by history and physical     examination, supported by imaging studies and electrodiagnostic tests. No study has compared     the differences in pain, medication utilization, functional outcomes, or patient satisfaction     between interlaminar and targeted epidural injections in the cervical spine. In theory, the     technique of targeted epidural steroid delivery with a catheter has a lower risk of     accidental vascular trespass or disc penetration during the procedure, and far less risk of     dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as     compared with the interlaminar technique. The investigators hypothesize that this technique     results in superior pain control, decreased medication use, improved function and fewer     repeat injections. This data could improve patient safety and affect the evolving treatment     guidelines for cervical epidural injections.   "
90983|NCT02095184|"     More than three quarter of patients with breast cancer are treated by hormone pills called     tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production.     This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal     women. The female hormone estrogen is an important hormone for the growth of breast cancer     cells. Anastrozole (Arimidex®) and Letrozole (Femara®) are AIs that are approved by the Food     and Drug Administration (FDA). They have been used since 2005 to treat women with early stage     breast cancer.      When given before surgery (neoadjuvant), both anastrozole and letrozole have been shown to     successfully shrink breast cancer tumors in most patients. In over 50% of patients,     anastrozole and letrozole when given for about 4 months also helped to improve surgery     outcomes. On top of that, whether or not a patient responds to anastrozole and letrozole     before surgery can help the doctor decide whether that patient needs additional chemotherapy.      One of the things may influence the level of hormone is body weight. It has been previously     shown that postmenopausal women with higher body fat have higher level of female hormone as     well as an increased risk of breast cancer. This is likely due to an increase in aromatase     activity in the fatty tissue. However, at the current time AIs are used at the same doses in     all women with breast cancer no matter whether they have different body weight. Currently, we     do not know for certain whether the same doses of AIs work as well in patients with higher     body fat compared to patients with less body fat.      The purpose of this study is to see if women with higher body fat respond differently to AI     treatment compared to women with lower body fat.   "
90988|NCT02095119|"     The following is an open label, non comparative, pilot study of palliative treatment as a     second, third line or more of treatment in patients with recurrent, persistent or Metastatic     Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating     the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal     Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks     for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800     mg/m2/BSA in patients with renal failure (Creatinine clearance <60).      Secondary objectives consist of evaluating disease-free survival, overall survival and assess     patient tolerance to treatment with Nimotuzumab.   "
90994|NCT02095041|"     Oxygen is carried in the blood attached to hemoglobin molecules. Oxygen saturation is a     measure of how much oxygen hemoglobin is carrying as a percentage of the maximum it could     carry. Oxygen saturation can be measured non-invasively using pulse oximetry. On occasion,     term infants are admitted to the intensive care nursery for monitoring and show variability     in their oxygen saturation despite appearing well. As healthy newborns do not undergo routine     monitoring of oxygen saturation, health care team do not know the degree to which variability     in oxygen saturation are a normal phenomenon. With increasing interest in using pulse     oximetry as a screening tool to identify at risk newborns, it is important to have a clear     understanding of postnatal oxygen saturation trends and their variability in healthy babies.      In our study, Investigators will measure oxygen saturation on healthy newborns repeatedly and     for extended periods. This will allow us to describe both the variability in oxygen     saturations and the pattern of changes observed in oxygen saturations over time in healthy     newborns. To increase our confidence that babies included in our study were healthy at birth,     they will be followed for 8 weeks to identify indicators of perinatal disease that was missed     clinically. Any babies subsequently identified as having significant disease will be analyzed     separately from the main cohort of healthy babies. Furthermore, the oxygen saturation     readings will be obscured so as not to influence caregivers inappropriately. Lastly, pulse     oximetry measurements will be performed after discharge from hospital (on day 3 to 4),     potentially increasing the clinical utility of this study as it has repeatedly been stated in     the literature that the sensitivity of pulse oximetry to detect important underlying disease     increases significantly if performed several days after birth. This study will provide     important and novel normative data.   "
94404|NCT02050425|"     Clinical trial in patients with obstructive sleep apnoea that are randomised to either     continue or withdraw continuous positive airway pressure therapy to identify a     disease-specific exhaled breath pattern by mass spectrometry.   "
90989|NCT02095106|"     Distal radius fractures are one of the most commonly seen fractures in children.     Traditionally, minimally angulated or non-displaced distal radius fractures are treated with     short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts     used must be kept dry to prevent inflammation and potential infection. If a fiberglass cast     gets wet, it must be removed and replaced. In general, waterproof casting has been shown to     improve patient comfort and overall satisfaction.      We intend to explore the efficacy of a new, waterproof cast made of a hybrid mesh in the     treatment of minimally angulated distal radius fractures in children using a randomized,     controlled, cross-over study design. We will include patients between 4 and 14 years of age     with minimally angulated distal radius fractures (<15 degrees of angulation on sagittal or     coronal planes) presented to the Orthopaedic Institute for Children Urgent Care Facility     within 7 days of injury. As determined by a power analysis, a total of 26 patients will be     enrolled in the study.      Patients eligible for the study will be randomized into one of two equally sized (n=13)     groups: patients in Group 1 will receive a short arm cast made of the waterproof hybrid mesh     material and patients in Group 2 will receive a regular fiberglass cast. Both groups will     follow-up at two weeks for clinical and radiological evaluation, after which they will be     transitioned into a regular fiberglass cast (Group 1) or a hybrid mesh waterproof cast (Group     2) for an additional two weeks. This crossover will allow both groups to experience each type     of cast. After four weeks of immobilization, patients in both groups will discontinue casting     and be advised to avoid contact sports or strenuous activities until week 8.      Patients in both groups will follow up 8 weeks after initial treatment for clinical and     radiological evaluation to evaluate range of motion, pain, and fracture alignment. Physical     function will be evaluated at weeks 1, 2, and 4 using the Activities Scale for Kids -     Performance, a validated, highly reliable, self-reported measure that assesses physical     function in children between 5 and 15 years. Pain will be evaluated using the Faces Pain     Scale, a validated, highly reliable scale commonly used in the pediatric population. Patient     satisfaction will be measured at Weeks 1, 2, and 4, and the radiographs at Week 8 will be     compared with initial radiographs to assess fracture displacement and angulation. Skin     changes will be assessed at week 2 and week 4 by an independent observer blinded to the type     of cast that has been removed and digital photographs will be obtained and analyzed using     ImageJ Image Processing and Analysis Software to calculate the surface area of any described     skin changes as a percentage of total skin area originally covered by the cast. Itching will     be assessed at weeks 1, 2, and 4 using a visual analogue scale in which a horizontal line of     100 mm will be presented to the patient with no itching at the left end of the scale and     strongest itching at the right end.      We hope to determine whether the new, waterproof cast can result in similar clinical outcomes     and patient satisfaction for distal radius fractures as compared with the traditional     fiberglass cast.   "
90990|NCT02095093|"     Leg length discrepancies following total hip arthroplasty have been associated with nerve     palsies, gait abnormalities, and lower back pain. Leg length discrepancies are related to     poorer functional outcomes and patient dissatisfaction. Failure to restore femoral offset     following total hip arthroplasty has been linked to decreased range of motion and abductor     muscle strength, impingement, limping, higher dislocation rates, increased polyethylene wear,     and loosening of implants. Computer navigation has shown to improve the accuracy of leg     length and hip offset during total hip arthroplasty. The investigators research objective is     to prove the accuracy of the Intellijoint HIP™ system for determining leg length and hip     offset. The investigators hypothesis was that Intellijoint HIP™, an imageless intraoperative     intelligent instrument, could improve the accuracy of leg length and hip offset during     primary total hip arthroplasty. The investigators plan to study this hypothesis in humans by     comparing the leg length and hip offset discrepancies produced with Intellijoint HIP™ to the     standard at the investigators institution, which is a pin and outrigger system.   "
90991|NCT02095080|"     Amino acid are the building blocks of the body's protein. Some amino acids, including     leucine, cannot be made in the body and must be obtained from diet, these are called     essential. With increase in age the body's muscle mass decrease and studies have suggested     that dietary supplementation of leucine may have potential health benefits in elderly in     regards to prevention of age related loss of lean muscle mass, and thus may help improve the     quality of life in elderly.      Currently, a safe upper dietary intake level of leucine has not been established for healthy     elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of     lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy     elderly.      The purpose of this study is to determine the tolerable upper intake level (UL) of leucine in     healthy elderly men (70 - 75 yrs)      The investigators hypothesize that with a careful graded stepwise increase in leucine intake     in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's     ability to oxidize/dispose of excess amino acids will reach a maximum. With increased leucine     intakes we hypothesize an increase in plasma ammonia concentrations and increases in plasma     leucine and urinary leucine excretion.   "
90992|NCT02095067|"     The prehospital resources are limited. The emergency medical dispatch center (EMDC) is manned     by qualified health care personnel around the clock. The investigators believe that the EMDC     is an unexploited resource in the prehospital treatment of patients. By the use of     videoconferencing the investigators will activate this resource.      Mobile videoconferencing between ambulances and physician at the EMDC enables patient     consultation at a distance. Video consultation between patient and the physician at the EMDC     can take place when the patient is at home or in the ambulance.      The primary aim of this study is to examine the effect of video consultation between     physicians at the EMDC and patients receiving treatment by ambulance personnel on the number     of patients receiving final treatment on-site in the pre hospital setting.   "
90993|NCT02095054|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of regorafenib and cetuximab that can be given to patients with advanced solid     tumors. The safety and effectiveness of this drug combination will also be studied.   "
91002|NCT02094937|"     The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25     micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low to     middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period, Period 1     (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects with well     controlled asthma after completing a run-in period of 4 weeks will be switched from     middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI 100/25     mcg for an 8 weeks treatment period (Period 1). After this, subjects will be randomized in a     1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily or FF 100 mcg     once daily in a 12 week double blind treatment period (Period 2). There will be a 1 week     Follow-up Period following completion of the double-blind treatment period, or early     withdrawal from the study. Overall , the total duration of subject's participation in the     study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of companies.   "
91005|NCT02094898|"     The purpose of this research study was to find out if the medication known as ketamine could     help the symptoms of depression. This drug is approved by the U.S. Food and Drug     Administration (FDA) as an anesthetic agent; however, it is not approved for use in     depression treatment. The FDA allowed the use of this drug in this research study.   "
91006|NCT02094885|"     To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective     vascular surgery.   "
90995|NCT02095028|"     Background: Maternal obesity is associated with higher risks of adverse maternal and fetal     complications, but the effects of dietary and lifestyle interventions on gestational weight     gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.      Objective: This study examined whether intensive dietary and lifestyle interventions     initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy     outcomes in Chinese obese pregnant women.      Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of     gestation.The sample size was estimated using GWG reduction as the primary outcome variable.     The investigators pilot study (data not published) showed the gestational weight gain was     12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in     GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in     intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up     during pregnancy, the total sample size required was 136 women in intervention group and 68     in control group(standard care group). Participants were randomly assigned to the control or     the intervention group. The intervention focused on restricting energy intake combined with     behavioral lifestyle modification through participation in group sessions and individual     counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes     were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during     pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian     section.      Hypothesis:The intensive dietary and lifestyle intervention performed from the first     trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy     outcomes.   "
90996|NCT02095015|"     Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease     caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost     exclusively in boys, with an incidence of approximately 1.3 per 100,000 live male births.1     Early identification of MPS II is challenging because some initial features, such as chronic     runny nose, otitis media, and hernias, are commonly seen in the general population. As a     result, even though the signs and symptoms of MPS II typically appear early in childhood, the     diagnosis may lag behind by several years.      The primary objective of this international multi-center study is to evaluate the positive     screening rate of MPS II subjects by screening a high-risk male pediatric population who have     had or are scheduled for 1 or more specific ENT surgical procedures (adenoidectomy and/or     tonsillectomy and/or tympanostomy) and who have a previously repaired or present evidence of     an inguinal and/or umbilical hernia.   "
90997|NCT02095002|"     To explore the effect of modified valsalva maneuver on the filling degree of right internal     jugular vein.      Method: The anteroposterior diameter and left-right diameter of right internal jugular vein     in thirty adult gynecology patients were recorded during normal respiration and modified     valsalva maneuver respectively.      Investigators hypothesis that modified valsalva maneuver would enchance the filling degree of     right internal jugular vein.   "
90998|NCT02094989|"     The electrocardiogram (ECG) is an important diagnostic procedure in medicine mainly to detect     circulation disorders and problems of the spread of the electrical heart impulse. It is     frequently the first measure in clinical practice when angina pectoris, acute myocardial     infarction or an arrhythmia are suspected. The ECG is easy to perform, safe and cheap.      Posture changes are known to cause alterations of the ECG [1]. Deviation of the electrical     heart axis (EHA) [2], temporary changes of the QRS morphology and ST-segment alterations are     of particular importance in view of diagnostic accuracy [3], [4]. In ambulatory ECG     recordings ST-segment alterations for instance might mistakenly be interpreted as cardiac     ischemia [5]. Artifacts could be minimized by the concurrent determination of the deviation     of the electrical heart axis [6] [7]or by using posture detectors [8] helping to correlate     ECG changes to posture changes.      Due to the emergence of new computer based opportunities ambulatory ECG in the sense of home     monitoring is an emerging market. Together with the superiority compared to the scalar ECG in     detecting certain pathologies, like myocardial infarction and right ventricular hypertrophy,     the VCG gained new interest in recent years [9]. Four ECG leads are sufficient to synthesize     a standard 12-lead ECG from a VCG and vice versa with a transformation matrix [10] [11].The     redirection of the spatial VCG after posture changes has been determined for the QRS loop     with the Frank leads, which is the reference method for constructing the VCG [12][13].      4 leads of an ambulatory ECG are sufficient to construct the VCG if arranged approximately in     the position of three rectangular axes. Doctors are best trained to interpret standard 12     lead ECGs. With optimization of the leads of ambulatory (Holter) ECG towards the three     rectangular axes, this might allow mathematical transformation into the standard 12 lead ECG.     A precondition would be that the transformation matrix is independent of posture. To date,     transformation matrix between Frank VCG and standard 12 lead ECG has only been calculated in     resting ECGs [5].      This is the first study which investigates the transformation matrix in different postures.     Additionally, the investigators will investigate for the first time prospectively for known     artefacts of stress testing and ambulatory ECGs.      Aim:      Simultaneous prospective recording of the standard 12 lead ECG and the Frank-lead VCG in     different postures is expected to add information on potential causes of artifacts of the ECG     caused by posture changes. During continuous recording, the investigators will investigate     the accuracy of the linear affine transformation with posture, the occurrence (dimension and     duration) of ECG/ VCG morphology changes and ST-segment alterations, and VCG angle changes in     dependence of posture changes in healthy young men.      Hypothesis The investigators hypothesis is that the transformation matrix between Frank-Lead     VCG and standard 12-lead ECG is posture dependent.      Artefacts of the ECG due to posture changes are systematic. The knowledge of the systematics     improves the diagnostic accuracy of ambulatory ECG and stress testing.   "
90999|NCT02094976|"     Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to     increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position     has been known to increase IAP. In clinical field, various apparatuses has developed to     minimize IAP elevation during prone position operation.      In this study, we would compare the changes of IAP and respiratory system compliance     according to positional apparatus in prone position.   "
91000|NCT02094963|"     The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel     in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.   "
91001|NCT02094950|"     This is a single arm clinical trial to establish the feasibility of conducting a clinical     trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed     chemoradiotherapy. Twelve subjects with dyspnea will be recruited to this clinical trial. Up     to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. The primary     outcome will be dyspnea as measured by the English version of the Cancer Dyspnea Scale at the     completion of the intervention.   "
91014|NCT02094781|"     The purpose of this study was to evaluate the effect of combined whey protein and creatine     supplement, as compared with whey protein supplement alone, on change in upper and lower body     strength.   "
91003|NCT02094924|"     This study is required to confirm the suitability of a candidate FDC of 16mg candesartan     cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to     allow the design of a future pivotal bioequivalence study. This study aims to determine the     relative bioavailability of a FDC tablet formulation of 16mg candesartan cilexetil/12.5mg     HCTZ relative to the reference product of same fixed dose combination (16mg candesartan     cilexetil/12.5mg HCTZ) in healthy adult humans. This will be an open-label, randomised,     single dose, two-way crossover study. Each subject will participate in two treatment periods     and will be randomized to one of two sequences and administered one of the two treatments, A     or B, as per the randomization schedule. The two treatment periods will be separated by a     washout period of 7 to 14 days to ensure the candesartan and HCTZ have been effectively     eliminated from the subject between dosing occasions. The study will enroll 16 healthy     subjects to ensure that 14 subjects complete the study as planned.   "
91004|NCT02094911|"     The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER     diabetes prevention intervention in Dutch primary health care.   "
91008|NCT02094859|"     The primary purpose of this Study is evaluation of the safety and performance of the     GlucoClear System (System).      The primary safety objective will be assessed by:      • Evaluation of any serious adverse device effects upon Sensor insertion through Sensor     removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.      The primary performance objective will be evaluated using the following criteria:      15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20%     accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤     75 mg/dL and within ±20% of Comparator values > 75 mg/dL).   "
91009|NCT02094846|"     The aim of the study was to assess the effect of an individualized intervention based on cell     phones to improve glycemic control in patients with type 2 diabetes attending Epidemiology     Research Unit in Cuernavaca, Morelos. Mexico   "
91010|NCT02094833|"     The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep     B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6     months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given     at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in     South Korean infants that received a birth dose of Hep B and born to mothers documented to be     serum anti-HBs Ag negative.      Primary Objective        -  To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus,          poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens          (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B,          one month after the third dose of combined vaccines.      Secondary Objectives:        -  To further study the immunogenicity of the two vaccination schemes, before the first          dose and one month after the last dose of vaccines.        -  To study the safety after each and any dose of vaccines administered in the two          vaccination schemes   "
91011|NCT02094820|"     Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition characterized     by severe and disabling fatigue. To date much research has focused on finding out whether CFS     is caused by mainly physical or psychological factors. Perhaps as a result of this, few     studies have examined the relationship between CFS and quality of life, in particular, more     positive aspects of mental health, such as an individual's sense of purpose, autonomy and     close relationships.      This study will address these limitations by examining Ryff's (1989) six domains of     psychological well-being (PWB), and other aspects of well-being including positive emotions,     in CFS. It will also examine the relationship between measures of symptomology, emotional     distress and PWB.      Method: This is a cross-sectional, questionnaire-based study with a clinical sample of adults     with CFS. Participants will complete valid measures of well-being and symptomology.      Results: We expect to find that compared to general population norms, individuals with CFS     score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to symptom     measures. There are however, no grounds for making strong predictions.      Implications: This study will advance our understanding of quality of life in CFS.     Clinically, it has the potential to enrich and inform therapeutic interventions.   "
91012|NCT02094807|"     The purpose of this prospective randomized controlled study is to determine whether acute and     chronic pain in patients who suffer multiple traumatic rib fractures is decreased after     surgical management as compared to conservative management.   "
91013|NCT02094794|"     This phase II trial studies the safety and efficacy of total marrow and lymphoid irradiation     (TMLI) in combination with two chemotherapy drugs, etoposide and cyclophosphamide, as a     preparative regimen before donor stem cell transplant in treating patients with high-risk     acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who have failed previous     therapy. Intensity-modulated radiation therapy (IMRT) uses imaging to provide a     three-dimensional view of the area to be irradiated. Doctors can then shape and direct the     radiation beams at the area from multiple directions while avoiding, as much as possible,     nearby organs. TMLI is a method of using IMRT to direct radiation to the bone marrow.     Radiation therapy is given before transplant to suppress the immune system, prevent rejection     of the transplanted cells, and wipe out any remaining cancer cells. TMLI may allow a greater     radiation dose to be delivered to the bone marrow as a preparative regimen before transplant     while causing fewer side effects than standard radiation therapy.   "
91015|NCT02094768|"     Much attention has been directed at the unhealthy effects of sugar-sweetened beverages     (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults,     SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared     to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda     with milk had the added benefit of also reducing systolic blood pressure. While several     studies have investigated the effects of SSBs on weight gain in children, no published     studies have investigated their effects on lipid and lipoprotein risk factors under     isocaloric conditions in metabolically at-risk adolescents, who are among the greatest     consumers of SSBs. The main objective of this study is to test whether isocaloric replacement     of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood     pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are     habitual soda consumers. The investigators will test this in a 8 week randomized two period     crossover trial in 30 overweight and obese adolescent males who are self-reported habitual     consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda     containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks     each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and     blood samples will be collected at screen and at the end of each intervention period. Plasma     measurements will include LDL peak particle diameter; lipoprotein subclass concentrations;     triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and     insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.   "
91044|NCT02094391|"     Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma     (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the     aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the     progression free survival for the patients having an adjuvant treatment by Ipilimumab in this     patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at     least a doubling of this period would be a clinically highly significant result.   "
91016|NCT02094755|"     Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb     loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a     major cause of death and disability (secondary to myocardial infarction, stroke and     amputation). The mortality in patients with CLI approaches 25% and 50% at one and five years     respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin     and clopidogrel (previously referred to as resistance) is associated with an increased risk     of recurrent cardiovascular events after percutaneous coronary interventions and acute     coronary syndromes. The prevalence and significance of HPR in patients with critical limb     ischemia treated with aspirin and/or clopidogrel is not known.      The investigators project aims to investigate the prevalence of HPR (to aspirin and     clopidogrel) in one hundred patients with diagnosis of critical limb ischemia encountered at     University of Southern California affiliated hospitals (Los Angeles County Hospital and Keck     Hospital of USC).   "
91017|NCT02094742|"     This pilot study examines the feasibility and turnaround time of performing and obtaining     data from a few key molecular assays. These assays will be performed using different     laboratories and technologies from core biopsies taken from patients diagnosed with invasive     recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed     using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated     for ease of use to screen patients for participation in future molecularly defined clinical     trials in breast cancer.   "
91018|NCT02094729|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics,     immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in     subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild     Alzheimer's disease.   "
91019|NCT02094716|"     To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5%     with that of vehicle in subjects with scabies.   "
91020|NCT02094703|"     The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for     short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary     tract infection in females.   "
91021|NCT02094690|"     The purpose of this study is to assess the effect of two protocols of physiotherapeutic     exercises in the maintenance and/or increase of the mandibular range of movement in patients     suffering from head and neck cancer (HNC) who are undergoing radiotherapy.   "
91022|NCT02094677|"     The objective of the study is to compare the overall subjective preference between two Daily     Disposable hydrogel lenses when refitted into a third hydrogel lens.   "
91023|NCT02094664|"     The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen     in children with bronchiolitis.      The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will     optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing,     and 3) decrease length of hospital stay.   "
91024|NCT02094651|"     The purpose of this study is to determine if treatment of epileptiform abnormalities in     children with autism spectrum disorder will improve any behaviors in these children. The     investigators will study a number of different behavioral outcomes including behaviors     related to attention, social communication, repetitive behaviors, maladaptive behaviors,     language, motor and sensory, and sleep. The investigators will use an anticonvulsant     medication called valproic acid (in the form of sodium divalproex).   "
91025|NCT02094638|"     Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of     retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in     the real world, observe the adverse drug reactions/ adverse drug events during treatment, and     figure out why Tanreqing induced severe allergic reaction happens.   "
91026|NCT02094625|"     Cisplatin is a key chemotherapy agent for the treatment of multiple childhood cancers but     causes permanent hearing loss. This study investigates the drug N-acetylcysteine (NAC) to     determine the dose necessary to protect hearing and also how well tolerated NAC is when     combined with chemotherapy.   "
91027|NCT02094612|"     The study goal is to examine whether the use of an objective computerized neuroassessment     (the Quotient System) for Attention-Deficit/Hyperactivity Disorder (ADHD) is related to     improved outcomes among pediatric patients being assessed and treated for ADHD.   "
91028|NCT02094599|"     The primary objective of this study is to evaluate the abuse potential of dronabinol oral     solution in recreational cannabinoid users.   "
91029|NCT02094586|"     The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.   "
93165|NCT02066623|"     The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety     as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system     in patients suffering from coronary artery disease.   "
91033|NCT02094534|"     This will be a prospective, randomized, double-blind, placebo controlled study. Patients with     established Type 1 diabetes will be eligible for entry into the study. Eligible patients will     be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the     inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will     report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring     (CGM) device. Patients will be given standardized meals and snacks for the duration of their     inpatient visit.   "
91034|NCT02094521|"     This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing     conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.   "
91045|NCT02094378|"     The purpose of this study is to assess the cognitive effects associated with administration     of intranasal esketamine 84 mg.   "
91046|NCT02094365|"     This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo     control in the respiratory syncytial virus challenge model.   "
91047|NCT02094352|"     The purpose of this study is to determine whether epidural and ketamine infusions are     effective in the treatment of Complex Regional Pain Syndrome (CRPS).   "
91246|NCT02091739|"     The objective of this study is to investigate the efficacy and safety of two different dose     levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary     flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a     result of various neurological conditions in adult subjects.   "
91035|NCT02094508|"     Background:      - Malaria is a disease that affects many children and adults in Uganda and Africa. If it is     not treated, it can make some people severely ill. TMP-SMX (Trade names Bactrim, Septrin) is     a drug that is given to children born to HIV-positive mothers to help prevent infection.     Studies have shown that TMP-SMX also may kill malaria infection in the very early stages of     infection in the body, which may positively impact the way the body can fight malaria     infection. Researchers want to know if giving TMP-SMX for 6 months longer than usual helps     children fight malaria better in this way.      Objective:      - To find out if taking TMP-SMX for longer than usual helps fight off malaria in infants.      Eligibility:      - Infants 0-6 weeks of age who are HIV negative.      Design:        -  Infants will be screened with a medical history and physical exam. A small amount of          blood will be taken. The mothers medical records will be reviewed. Mothers will be asked          about when they breastfeed.        -  Participants will take TMP-SMX according to their doctor s orders. In Uganda, mothers          will get a mosquito net with insecticide on it as per standard of care.        -  Participants will come to the clinic once a month, every month, until the study ends in          2 3 years. Each visit will repeat the screening visit.        -  Participants will also visit the clinic every month for a medical history, physical          exam, and different blood tests.        -  Six weeks after breastfeeding is stopped, children taking TMP-SMX will come into the          clinic and will either be taken off the drug or will continue taking the drug for 6 more          months.        -  If a child becomes sick, it is important that the mother bring him or her to the RHSP          clinic in Rakai.   "
91036|NCT02094495|"     The aim of this study are to to evaluate the knowledge and understanding on tamoxifen     theraphy for breast cancer patients and examine the decision conflict scale and satisfaction     with decision scale while making decision to take tamoxifen.   "
91037|NCT02094482|"     The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture     above) in order to stiffen and stabilize the soft palate, which may reduce the severity of     airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea).     Indications for use of the System include: symptomatic, habitual, social snoring due to     palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction.     The System is labeled for use by physicians only.      The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.      Study hypothesis: Reduction of initial AHI ≥20%   "
91038|NCT02094469|"     This study will be conducted in accordance with the local regulation of New Drug Application.     Overall duration of this trial will be 3 years after approval of MFDS.      Each subject will participate around 26 weeks, which include the 24 weeks treatment period     and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks     treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn     subjects with other reason also have 2 weeks follow up period.   "
91039|NCT02094456|"     Diverticular bleeding is the most common cause of acute lower gastrointestinal bleeding     (LGIB) in Western populations. Although self-limited in 85% of cases, some patients may     require hospitalization with blood transfusion and emergent intervention, with significant     associated morbidity and mortality. Up to 25% of patients with an initial bleeding episode     will have subsequent episodes.      Diverticula form at weak points along the colon wall, where the vasa recta enter the circular     muscle layer of the colon. Diverticular bleeding is attributed to thinning of the blood     vessels as they cross over the dome of a diverticulum. Endoscopic clipping of actively     bleeding colonic diverticula has been recognized as a safe and effective treatment for acute     LGIB since the mid1990s. Patients selected would have had previous colonoscopy to exclude     other causes of bleeding (e.g. angiodysplasia, colorectal cancer).      The investigators propose prophylactic elective endoscopic diverticular clipping in patients     who have had at least 1 episode of acute LGIB requiring hospitalization. This would involve     applying endoscopic clips to the base of every diverticula in a patient's colon, such that     any bleeding source would effectively be excluded. The investigators would later reevaluate     patients for colonoscopic appearance of diverticula to assess their diverticular disease.      The investigators hypothesize that patients undergoing endoscopic diverticular clipping will     not have repeat episodes of bleeding.   "
91040|NCT02094443|"     The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus     (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving     different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks     treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed     interferon therapy or were intolerant or unable to take interferon.   "
91041|NCT02094430|"     The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in     pediatric patients with congenital fibrinogen deficiency.   "
91042|NCT02094417|"     The present study will be conducted to evaluate the efficacy and safety of AMG531 and to     determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when     it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with     immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics     of this product. Its efficacy and safety during the extension period beyond one year will     also be evaluated.   "
91094|NCT02093741|"     This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the     safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI)     during routine clinical practice in children until 12 years of age. This surveillance study     is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.   "
91095|NCT02093728|"     Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of     Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers   "
91043|NCT02094404|"     Currently, the Manchester Triage System (MTS) is used to triage all children presenting at     the emergency department(ED) in this hospital. This system has been proven safe, but many     patients are classified as too urgent. In this hospital adults are prioritised at the ED by a     score based on vital signs, the early warning score. A similar score is developed suitable     for children. This score, the Pediatric Early Warning Score (PEWS), is already used to     determine clinical deterioration.      The investigators hypothesize that children can be triaged safely with the PEWS.      If it is safe, there will be one triage system again at the ED. Another advantage will be     more continuity in assessing the condition of patients who are admitted to the hospital.   "
91048|NCT02094339|"     Postoperative pain after total knee arthroplasty (TKA) can be difficult to manage and may     delay recovery. There are multimodal postoperative pain management after TKA, including     intravenous opioids, epidural analgesia, peripheral nerve blocks or periarticular     infiltration with local anesthetics. All of these treatments may lead to side effects such as     nausea, headache, hypotension, urinary retention, partial motor block and infection of the     knee. Therefore the investigators will compare three methods of postoperative analgesic after     TKA by their efficiency and complication.   "
91049|NCT02094326|"     The purpose of this study is to find patterns in the use of non-biological DMARDs as the     initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may     impact therapeutic decisions in real life in the Spanish Andalusian region.   "
91050|NCT02094313|"     Recently, concerns about the effect of atorvastatin intake on men fertility have been raised.     However, this statin has never been investigated regarding its influence on male fertility,     notably sperm quality.      The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of     cholesterol blood levels, induced by taking atorvastatin, on sperm quality of     normocholesterolaemic and healthy men without confounding factors.   "
91051|NCT02094300|"     The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the     safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of     patients with aortic dissection.   "
91052|NCT02094287|"     The study is initiated in the indication of atopic dermatitis to study the impact of placebo     in the treatment of pruritus. Classical conditioning and expectation via     instructions/anticipation maintain the effect of placebo.   "
91053|NCT02094274|"     The purpose of this study is to assess the the ability of a single dose of LAS40468     administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®)     administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety     and tolerability of the treatments   "
91054|NCT02094261|"     A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in     Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has     Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy     and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive   "
91055|NCT02094248|"     The primary objectives of this study are to assess the impact of rhTPO on mortality among     severe sepsis patients with thrombocytopenia, as well as changes of platelet counts and     platelet transfusion rates.   "
91056|NCT02094235|"     This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment.     Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group     (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of     age) according to the sequential cohorts by confirming the safety.   "
91057|NCT02094222|"     Byler Disease is the result of a homozygous missense (G308V) mutation in the ATP8B1 gene. The     disease is typically manifest in the first year of life on the basis of complications of     cholestasis; common presentations include jaundice, poor growth, bleeding related to vitamin     K deficiency, and/or weak bones related to vitamin D deficiency. Early management of Byler     Disease is directed at nutritional issues which tend to be responsive to medical     intervention, unlike the pruritus/scratching which remains a devastating problem. Progressive     liver disease develops in Byler Disease and can lead to cirrhosis and end-stage liver     disease. This is an open label expanded access protocol of RAVICTI in children with Byler     Disease. The primary hypothesis is that the administration of RAVICTI in these children is     feasible, well tolerated and safe. It is also hypothesized that RAVICTI treatment leads to an     improvement in biochemical markers of liver disease and it may ameliorates or prevents the     development of scratching behavior as a manifestation of pruritus attributed to the liver     disease.   "
91058|NCT02094209|"     20 patients having received an AO large external fixator at the tibia will be equipped with a     data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the     external fixator. The device continuously measures deformation of the fixator frame due to     weight bearing for up to 6 months by means of a strain gauge. Several parameters are     calculated from the recorded change in the strain signal and are stored at a regular     interval.   "
91096|NCT02093715|"     The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and     blood cytokines during acute bronchiolitis, and to seek for correlation between these markers     and future development of asthma.   "
91059|NCT02094196|"     The aim of this project is to assess reward- based learning behavior and its association with     alterations in dopaminergic and glutamatergic transmission in detoxified alcohol-dependent     patients and matched controls.      The investigators will explore how these alterations interact with clinical and psychosocial     factors which can modify the relapse risk and learning deficits.      Patients will be detoxified in an inpatient setting. Clinical assessments, behavioral     paradigms of learning and brain imaging will be carried out within at least 4 half- lives     after any psychotropic medication.      The investigators will implement and apply functional imaging paradigms assessing     Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters     of learning with alcohol craving, intake and prospective relapse risk.      In this project, the impact of the dopamine x glutamate interaction on learning deficits and     consecutive relapse probability is targeted with [18F]fallypride PET and the measurement of     absolute concentrations of glutamate with magnetic resonance spectroscopy (MRS).   "
91060|NCT02094183|"     Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change   "
91061|NCT02094170|"     The prevalence of overweight and obesity are increasing worldwide. In the U.S., approximately     85,000 new cancer cases per year are related to obesity. Understanding lifestyle behaviors,     their causes, and relations to cancer are critical. Where people spend their time during the     day may be related to their risk of getting cancer. This project will assess behaviors in     different locations across the day and relate exposure to different environments to     biological outcomes.   "
91116|NCT02093442|"     Endometrial injury performed in a cycle preceding the one for embryo transfer is associated     with an increased implantation and pregnancy rate when carried out during the month preceding     that of ovulation induction and fresh embryo transfer. However, there is no evidence about     the effect of this intervention on the transfer of cryopreserved embryos.   "
91062|NCT02094157|"     Approximately 2 million patients in North America are currently treated with the blood     thinner warfarin. These patients have every year more than 200,000 invasive procedures, for     which warfarin must be stopped to avoid bleeding complication. To protect the patient against     blood clots and stroke while warfarin is stopped, most physicians today order bridging with     low-molecular-weight heparin (LMWH). This is another blood thinner and it is injected under     the skin during 3 days before the procedure. For implantation of pacemaker or defibrillator     (27,000/year in Canada) the bridging routines vary a lot.The common bridging treatment     with LMWH for 3 days before pacemaker surgery causes bleeding in the pocket where the     pacemaker is placed in about 5%. For comparison, patients not on any blood thinners develop     this bleeding in 2% after this surgery. Pocket bleeding may require evacuation of the blood     collection and may cause infection. Pocket bleeding is thus a fairly common and clinically     important but rarely a dangerous bleeding complication. It is a suitable safety endpoint in a     study of bridging of blood thinners. LMWH costs $80-120, for which some patients are not     covered. They have to be taught self-injection technique or have a nurse come to their home.     The main hypothesis is if patients on blood thinners can be managed more conveniently before     and after pacemaker surgery, without injections, without increased risk of pocket bleeding.   "
91063|NCT02094144|"     Community-dwelling women aged 55 or over are recruited at public meetings aimed at promoting     physical activity in postmenopausal women. Women are eligible and enrolled in the study if     they have no significant disease affecting lower limb function and if they have a sedentary     lifestyle. All study participants provide written informed consent to participate to the     study.      Women are then randomized either to the control group (women have to maintain their     lifestyle) or to the exercise group : 40 minutes of brisk walking 3d/wk for 6 months (two     supervised sessions and one session performed one their own per week with a detailed     program). The intensity of the program is adapted to the heart rate work and gradually     increases over the 6-month program. The objective of the study is to determine the health     benefits of brisk on walking ability, diet, muscle strength, balance, blood pressure, bone     density, body weight, lean and fat mass, depression symptoms, behavioral, emotional     responses, sleep quality, and biological indicators of health.   "
91064|NCT02094131|"     Experimental Procedure: The subjects underwent an initial interview in which was filled in a     form of anamnesis, in addition to being assessed and reassessed by spirometry, dynamic     circumference and manometer. Moreover, responded international physical activity     questionnaire (IPAQ - short version) in order to characterize the physical activity level of     each participant being classified as inactive, irregularly active, active, and very active.     The same examiner performed the assessments and reassessments of individuals after a training     program.   "
91066|NCT02094105|"     Importance: There are no global screening recommendations for esophageal squamous cell     carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of China     since 1970's. But up until now there no apparent evidence that would lead to a reduction in     disease morbidity and mortality.      Objective: To evaluate whether endoscopic screening and early intervention program could     reduce the incidence or mortality of ESCC.      Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening     was completed from November 1999 to May of 2000. Subjects in intervention group were examined     once during intervention period. The study follow-up concluded in December 2009.      Setting: High risk area of ESCC in China      Participants:Cluster sampling from communities with high rates of esophageal cancer. A set of     villages with was selected as the study intervention community. Age 40 to 69 years residents     were selected as an eligible population. Another set of villages was select as the control     population. Buffer villages were set up between intervention and control group.      Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous     lesions was undergone for the intervention group.      Main Outcome(s) and Measure(s): Incidence and mortality ESCC   "
91067|NCT02094092|"     This study will work on hypothetical assumption that compared to the arm supplemented with     placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing     time per 24 hours at one month post randomization. And that the L reuteri (intervention)     group at 7, 14, 21, days and 1 week after the therapy cessation will have:        -  Lower crying/fussing time per 24 hours.        -  Relief from colic pain        -  Longer sleep duration,        -  Higher scores on a standardized measure of maternal mental health   "
95624|NCT02034487|"     To evaluate the phenotype and biochemical characteristics of boys referred for delayed     puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the     diagnostic criteria and the effect of testosterone treatment.   "
91068|NCT02094079|"     The aim of the study was to evaluate the clinical control program in patients with     hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by     monitoring the patients every 4. week during pregnancy to keep the thyroid function     parameters within the recommended range?      A retrospective study of consecutive pregnant women with hypothyroidism followed at the     outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients     selected through electronic medical system. Blood tests for the The hormone levels drawn from     the laboratory of Clinical Biochemical Department, Herlev Hospital   "
91069|NCT02094066|"     The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood     transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.   "
91070|NCT02094053|"     The purpose of this double-blind, placebo-controlled, comparative study and open-label     extension study is to confirm the efficacy and safety of E2020 in subjects with Down syndrome     having regression symptoms and disabled activities of daily living.   "
91071|NCT02094040|"     The purpose of this study is to determine whether discharge follow-up visit by primary     physician and community-based nurse affects the risk of early re-hospitalisation among high     risk older people discharged from a medical ward.   "
91072|NCT02094027|"     To demonstrate the effectiveness of an easily administered intervention (guided self help)     aimed at reducing binge eating in patients undergoing bariatric surgery.      The investigators hypothesize that patients who have guided self help pre-operatively will     have reduced episodes of bingeing pre-operatively compared to those having treatment as usual     (bariatric surgery), which will be maintained in the post-operative period, and will be     associated with improved weight loss and psychological outcomes after surgery.   "
91073|NCT02094014|"     Impaired speech production is a major obstacle to full participation in life roles by stroke     survivors with aphasia and apraxia of speech. The proposed study will demonstrate the     short-term effects of auditory masking on speech disfluencies and identify individual factors     that predict a positive response, enabling future work to develop auditory masking as a     treatment adjuvant targeting long-term improvement in speech. Providing an additional     treatment option for adults with aphasia and apraxia of speech will have the clear benefit of     improving quality of life and allowing individuals to participate more actively in their     health care decisions through improved communication.   "
91074|NCT02094001|"     Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the     pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive     pulmonary hypertension (PH) and right ventricular failure- most common cause of death for     patients with PH. Riociguat, (ADEMPAS) is a member of a new class of drug recently approved     in Canada for the treatment of CTEPH.      This pilot study is designed to assess if at least 24 weeks of treatment with riociguat will     show changes in glucose metabolism and improved resting myocardial blood flow using positron     emission tomography ( PET ) imaging to measure myocardial function. The response between both     treatment naive patients as well as patients on maximally tolerated dose of riociguat with     tratment duration of at least 3 months will be included.   "
91075|NCT02093988|"     Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in     spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood loss.     When used intravenously, it has been shown to safe, efficacious, and effective in reducing     transfusion requirements and blood loss in spine surgeries. We want to evaluate the effect of     using TXA topically and intravenously to see if it further reduces blood loss in children     undergoing major surgery compared to IV TXA only   "
91076|NCT02093975|"     Physician manned rapid response vehicles are a limited resource in the prehospital handling     of acute patients.      In this study mobile videoconferencing between ambulances and the rapid response vehicles     enables patient consultation at a distance. Video consultation between patient and the     prehospital physician can take place when the patient is at home or in the ambulance.      The primary aim of this study is to examine the effect of video consultation between     physician manned rapid response vehicles and patients receiving treatment by ambulance     personnel on the number of patients receiving final treatment on-site in the pre-hospital     setting   "
91077|NCT02093962|"     The purpose of this study is to determine whether TH-302 in combination with pemetrexed is     safe and effective in the treatment of non-squamous non-small cell lung cancer.   "
91078|NCT02093949|"     To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection     with a multipolar catheter (Pentaray) and the  SCI 30-40  setting of CARTO CFAE algorithm.   "
91079|NCT02093936|"     Background: Induced sputum (IS) is a noninvasive methodology for evaluating airway     inflammation in a large number of pulmonary diseases, i.e, Asthma, Chronic obstructive     pulmonary disease and Interstitial Lung Diseases. Several studies have defined normal values     and cut-off points for this technique based on cellular components of IS, such as percentages     of eosinophils, neutrophils, macrophages and CD4/CD8 ratio of T cell lymphocytes. However,     normal values and cut-off points for lymphocyte percentages indicative of pathology have not     yet been established or validated. This component of IS has considerable clinical value.     Similar to other constituents of IS, it can provide biological insights into the pathogenesis     of respiratory disorders and contribute to establishing the diagnosis and guiding treatment     management of a variety of airway diseases.      The purposes of this study are to define normal values and cut-off points of lymphocytes in     IS among individuals with respiratory disorders and healthy volunteers, and to verify the     current reference values of the percentage of eosinophils, neutrophils and CD4/CD8 ratio in     IS.      Methods: A Cross Sectional study which includes a database on up to 900 patients who     participated in various studies conducted in the Pulmonary Laboratory of Tel Aviv Sourasky     Medical Center between 2005 to 2012 will be established. The study population will include     patients diagnosed as having various pulmonary diseases and a group of healthy volunteers who     will serve as controls. The cut-off for normal values of lymphocyte, eosinophil and     neutrophil percentages and CD4/CD8 ratio in IS will be defined by using ROC curves and     evaluating sensitivity and specificity. The comparison of the different values to those in     the literature will be done by using the Spearman rank correlation.      The results of this study will provide supplementary information on lymphocyte counts in IS     for identifying and treating various respiratory diseases.   "
91080|NCT02093923|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic     profile of multiple subcutaneous administrations of DX-2930 across a range of doses in     Hereditary Angioedema subjects.   "
91097|NCT02093702|"     The objective of this study is to assess whether a structured exercise program compared to     routine recommendation for exercise has any positive impact on disease outcome in patients     with type 2 diabetes.      This study aims to assess whether a structured exercise program has an impact on the     following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids, body     mass index and waist circumference. It also aims to assess the compliance and retention of     patients with type 2 diabetes in a structured exercise program.   "
91081|NCT02093910|"     Bortezomib was an important drug in the treatment of multiple myeloma (MM),and peripheral     neuropathy (PN) is a significant dose-limiting toxicity of bortezomib that typically occurs     within the first courses of bortezomib, reaches a plateau at cycle 5. Up to now, no effective     prophylaxis have been developed for PN. Monosialotetrahexosylganglioside, a nerve-protecting     drug,was often used to promote growth of nerve, and function restoration of damaged     nerve.Thus,the investigators hypothesized that combination of     Monosialotetrahexosylganglioside and bortezomib can reduce the incidence rate of peripheral     neuropathy (PN) and promote the relief of peripheral neuropathy (PN) in multiple myeloma (MM)     patients.   "
91082|NCT02093897|"     This is an international, multicenter, open-label study to assess the efficacy, safety, and     pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe     hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to < 12 years of age and at     least 25 subjects < 6 years of age who have undergone > 50 exposure days (EDs) with a     previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to     either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a     dose to be determined by the investigator. Hemostatic efficacy will be assessed by the     subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.   "
91083|NCT02093884|"     The objective of this study is to develop and test an emergency department (ED)-based     intervention which uses text messages to facilitate contraception initiation.   "
91084|NCT02093871|"     To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided     every 28 days in 3rd line ovarian cancer patients.   "
91085|NCT02093858|"     Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in     the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with     metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and     SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the     development of antipsychotics-induced metabolic syndrome.   "
91086|NCT02093845|"     The purpose of this study is to perform a randomised comparison between the SYNERGY and the     Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.   "
91087|NCT02093832|"     This study had four aims:        1. To evaluate the correlation between the planned preoperative cup size and the actual cup          size that was implanted in surgery.        2. To examine the absolute difference between the implanted cup size diameter and the          actual femoral head size diameter.        3. To examine the absolute difference between the planned cup size diameter and the actual          femoral head size diameter        4. To suggest an additional online monitoring tool on the accuracy of the preoperative          process and implant selection. We hypothesized that high accuracy rates will be found          between the preoperative planned cup size and the actual implanted cup size.          Furthermore, we hypothesized that strong correlations will be found between the planned          and actual implanted cup size and the actual femoral head diameter size.   "
91088|NCT02093819|"     To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics     (PK) of single rising doses of BI 416970. A further objective is to assess the influence of     CYP2C9 phenotype on the PK of BI 416970.   "
91089|NCT02093806|"     The purpose of this study is to measure the size of the round window niche and its relation     to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution     computerized tomography of the temporal bone, in order to assess preoperatively what is the     extent of obstruction of the round window membrane and whether there is a surgical     possibility of round window approach in the insertion of electrode array into the cochlea   "
91090|NCT02093793|"     To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems     Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic     intractable pain   "
91091|NCT02093780|"     In the present study, ulcerative colitis (UC) patients in the remission stage of the disease     will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide     diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a     role in decreasing the risk of UC development or management of UC-related symptoms or     relapse. Since the primary outcome of interest is the relapse rate in two groups, disease     status will be assessed monthly using appropriate tools. In order to find out the underlying     mechanisms that will relate the proposed diet to decreased flare rate, some laboratory     evaluations, which are mainly markers of inflammation or are related to gut microbiome will     be conducted. In the present study, the investigators will also perform state-of-the art     metabolomics tests, in order to study how the dietary changes will change the end     metabolites. In addition, the investigators will be able to explore if metabolomic profile of     participants can predict future UC relapse. This study will last for 6 months from baseline     wherein all the study subjects will receive appropriate dietary instructions in addition to     their stable doses of maintenance drug therapy.   "
91092|NCT02093767|"     Based on the efficacy of inulin and oligofructose in treating experimental colitis and     emerging evidence suggesting probiotics are efficacious in maintaining and inducing remission     in human ulcerative colitis (UC), the investigators intend to conduct an open label study     using Synergy-1, a 1:1 oligosaccharide/ inulin mixture, in patients with mild to moderately     active left-sided UC. The investigators hypothesize that oligofructose-enriched inulin     (Synergy-1) can be used safely in the treatment of mild to moderate UC, and daily oral     administration of Synergy-1 will result in the clinical improvement and/ or remission of     disease. Subjects will be randomized to either a 7.5g or 15g dose of Synergy-1 in order to     investigate what amount of the prebiotic is efficacious and tolerable in patients with active     UC. The clinical activity of disease will be evaluated using endoscopy and symptom scores.     The investigators will also study the effect Synergy-1 on mucosal histology, intestinal     microbiota composition and function and markers of inflammation (e.g. fecal calprotectin,     cytokines). The study will be for 9 weeks from baseline wherein all subjects will receive     Synergy-1 treatment. Half the subjects will receive a dose of 7.5g and half will receive 15g     daily.   "
91093|NCT02093754|"     This study will allow to assess liver related injuries in HIV patients.   "
91098|NCT02093689|"     The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative     Floppy Iris Syndrome in patients at risk.   "
91102|NCT02093637|"     The purpose of this study is to determine if the addition of Battlefield Auricular     Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to     ambulation without assistance, hours missed from work and increases quality of life after     lower extremity surgery at two Air Force Medical Centers.   "
91103|NCT02093611|"     We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance     motor unit recruitment while simultaneously blunting the decline in power and reaction time     that is typically seen during repetitive sprints. This will give researchers a better     understanding of the mechanism by which ATP supplementation can augment power, especially     under high fatiguing conditions.   "
91117|NCT02093429|"     The study design includes a 3-dose randomization phase to determine effective doses of     INCB047986 in patients with myelodysplastic syndrome (MDS) who are refractory or unlikely to     respond to erythropoiesis-stimulating agents (ESAs) followed by an extension phase.   "
91118|NCT02093416|"     Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical     population compared with non obese controls. Additionally serum levels of leptin, ghrelin,     motilin and PYY will be compared amongst the different BMI classes and a quality of life     questionnaire completed by all participants.      The hypothesis is that obese individuals have lower leptin receptors in enterocytes which is     partially responsible for the higher serum leptin levels without appropriate control of     satiety.   "
91247|NCT02091726|"     This is a field trial of the Unicirc instrument to excise the foreskin, plus use of     cyanoacrylate tissue adhesive to seal the wound.   "
91104|NCT02093598|"     Type of Application: Clinical trial of new indication.      Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously,     infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).     Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin).     Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09.      Primary Objective:        -  To identify in tumor samples future biomarkers associated with a short term exposure to          temsirolimus.        -  This is an exploratory clinical study. No efficacy objectives are included in this          clinical trial.      Secondary Objectives:        -  To estimate the tolerability for all temsirolimus-treated patients throughout the study          and up to 28 days after the last dose of temsirolimus.        -  To correlate observed changes with the different type of endometrial carcinoma (type I          and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D,          p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR),        -  To estimate the potential predictive value of some biomarkers (immunostaining for PTEN,          pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite          instability status.        -  To estimate the prognostic value of Ki67 expression after short-term presurgical therapy          exposure        -  To collect data about the differences in expression profile, assessed by RNA microarrays   "
91105|NCT02093585|"     Some but not all observational studies have found that current exposure to abacavir is     associated with increased risk of cardiovascular events such as myocardial infarction, stroke     and cardiovascular death. This study aim to investigate possible adverse effect of abacavir     on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients.     The study is an open-labeled cross-over trial, where patients receiving antiretroviral     therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa     for a period of 90 days.   "
91106|NCT02093572|"     The purpose of this study is to test the hypothesis that the disruption of the normal     (three meals a day) eating pattern and prolonged overnight fasting caused by skipping     breakfast: i) alters the expression of specific clock genes and clock gene targets involved     in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal     adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA)     concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong     plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying     healthy, lean persons either randomized to consume either 3 standard meals per day or omit     breakfast and consume 2 meals per day without changing daily calorie intake (skipping     breakfast group).   "
91107|NCT02093559|"     REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose     and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose     education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will     test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and     referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and     overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed     and already received take-home naloxone (the opioid antagonist used to reverse overdose).   "
91108|NCT02093546|"     The goal of this study is to check the effect of trametinib alone and when given with     GSK2141795 on biomarkers in patients with persistent or recurrent endometrial cancer.     Biomarkers are found in the blood/tissue and may be related to your reaction or response to     the study drug.   "
91109|NCT02093533|"     Membranoproliferative glomerulonephritis (MPGN) is the third or fourth leading cause of end     stage renal disease among the primary glomerulonephritis. Hyperactivation of the alternative     complement pathway and familial forms for all types of MPGN have been reported suggesting     that genetic abnormalities may play a predisposing role to the disease. In recent case     reports Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the     membrane attack complex ,is a safe and effective therapy.   "
91110|NCT02093520|"     Study Objective: To compare patient outcomes following treatment with either the MILD     procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal     stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy     as a contributing factor.   "
91111|NCT02093507|"     The purpose of this study is to determine whether the result of parent's feet manipulation     compared with nonmanipulated group within first 6 months of life and observe spectrum of the     disease within this period.   "
91112|NCT02093494|"     This is a randomized, open label study to evaluate the Initial Specimen Diversion Device     (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will     be derived from inpatient and/or outpatient settings in a variety of hospital departments     (e.g. ER, surgical, medical, etc.). Only samples that are collected via PIVC's may be     included in this study. The ISDD will be compared to current laboratory practices for the     collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as     collection of venipuncture blood for culture without an initial diversion method to divert     and sequester potential blood contaminants.   "
91113|NCT02093481|"     The experimental model is a semi-acute study where the purpose of the study is to evaluate     food factors related to colonially derived regulation of glucose metabolism (and related     parameters) and satiety in healthy subjects.   "
91114|NCT02093468|"     The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects     receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether     treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid     tissue perfusion in the effected blood vessel.   "
91115|NCT02093455|"     This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form)     with the purpose to test the impact of a four-month supplementation with Chardonnay Seed     Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and     seeds. We will examine the effect of CSF on parameters such as endothelial function (via     EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory     markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the     makeup of and impact on the gut microbiome (via stool samples).   "
91185|NCT02092532|"     The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept     injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.   "
91119|NCT02093403|"     This phase I trial studies the side effects and best dose of Selinexor when given together     with decitabine in treating patients with acute myeloid leukemia that has returned after     treatment (relapsed) or does not respond to treatment (refractory). Drugs used in     chemotherapy, such as decitabine and Selinexor, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing.   "
91120|NCT02093390|"     This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the     effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics     of TAK-385 in healthy adult subjects.   "
91121|NCT02093377|"     The aim of this randomized controlled trial is to test the effect of 12 weeks Adaptive     Servo-Ventilation (ASV) therapy (additionally to optimal medical management of myocardial     infarction) on myocardial salvage (MSI=myocardial salvage/area at risk, primary endpoint).   "
91122|NCT02093364|"     The purpose of this focused registry is to evaluate the clinical implications of the RHP     position (relative to the articulations) regarding functional and radiographic parameters in     patients treated with the RHP with a straight and curved stem.   "
91123|NCT02093351|"     This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of     the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of     anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible)     continued access to olaparib after the PK phase and will provide additional safety data.   "
91124|NCT02093338|"     The main objective of this intervention study is to evaluate the efficacy of Lactobacillus     fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and     Streptococcus as risk factors for mastitis in women with breast pain   "
91125|NCT02093325|"     The purpose of this study is evaluate the efficacy and safety of eltrombopag as a rescue of     isolated chemotherapy-induced thrombocytopenia in patients with gynecologic cancer.   "
91126|NCT02093312|"     The overall objective of the study is to investigate the effect of energy- and protein     enriched home delivered meals vs. habitual diet in malnourished patients suffering from     cancer on various endpoints.   "
91127|NCT02093299|"     Stroke patients are given prophylactic treatment with clopidogrel to prevent new strokes.     Some of these patients (the investigators don't know precisely how many, but previous studies     indicate 4-34%) are so called non-responders, when you measure on a blood sample from the     patient. These patients may have an increased risk for less effect of the treatment and     therefore a higher risk for a new stroke.      The investigators want to investigate if clopidogrel non-responders have a clinically     increased risk of a new stroke by following the patients for two years. With this study the     investigators aim to ensure that all patients get the best prophylactic treatment and reduce     the risk of early death and dependency of others.   "
91128|NCT02093286|"     To assess any serious systemic reaction within 30 minutes after Pentabio immunization   "
91129|NCT02093273|"     The objective of this study is to compare the antibody response 30 days after two doses of t     OPV   "
91130|NCT02093260|"     To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and     Children (Bridging Study)   "
91131|NCT02093247|"     This study is Observational multi-center, prospective study to characterize novel pathogen-     and host-related factors in hospitalized patients and patients in the Emergency Department     (ED) presenting with lower respiratory tract infections (LRTI) and/or sepsis.The Study's     objective is to develop a novel multi-parametric diagnostic model for the management of     patients with LRTI and/or sepsis that will be based on novel pathogen- and host-related     factors.   "
91132|NCT02093234|"     This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors     and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell     phone disease management system plus a community health worker (CHW) is superior to either a     cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of     7 Wellness Behaviors and 6 Clinical Goals.   "
91133|NCT02093221|"     This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of     human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years     old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM).     Currently enrolling ages 12-35 only. Once 25 patients are randomized and data is reviewed     enrollment will be opened to the child cohort. The purpose of this study is to evaluate the     safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.   "
95659|NCT02034032|"     The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to     Exercise Therapy at three months. Historical comparison will be made to Total Knee     Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.   "
91134|NCT02093195|"     Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in     reducing COPD exacerbation and hospitalization, improving the life quality, and postponing     the lung function decline. But for some patients with severe COPD, current treatment only     partially alleviates the symptoms and has little role in the lung function decline. In this     randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan     in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by     echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the     secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score     and mMRC/CAT score.   "
91135|NCT02093182|"     The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic     brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance     Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to     monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy,     highly operator dependent and more.      HS-1000 device, an investigational vasospasm detection device, has the potential to safely     diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality     for vasospasm measurement tool.      We aim to evaluate the correlation between the collected and analyzed data from the HS-1000     device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH)     patients.   "
91136|NCT02093169|"     To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma     concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu     AF35700   "
91137|NCT02093156|"     Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate     bowel preparation is essential for optimal visualization of the colorectal mucosa. However,     inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients     undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which     can be broadly categorized as patient-related or procedure-related. It has been shown that     split-dose regimen or some modified educational strategies can improve the quality of bowel     preparation. For the patients with possible IBP before the performing of colonoscopy, it may     be better to repeat bowel preparation with modified or enhanced strategies in case of failed     intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a     model to predict the quality of bowel preparation individually.   "
91138|NCT02093143|"     The most important considerations for the general anesthesia in diagnostic panendoscopy of     the upper airway is the maintenance of a patient's airway for optimal surgical exposure,     adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with     preserved spontaneous ventilation and total intravenous administration of anesthetic drugs     are widely use. Due to its pharmacological profile, propofol anesthesia is often considered     as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies     suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy     and tracheal intubation.      The aim of this study is to assess the impact of propofol remifentanil general anesthesia     compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of     the upper airway.   "
91139|NCT02093130|"     This project is designed to study whether pomegranate juice benefits cognitive abilities in     middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of     two treatment groups: either a placebo or the pomegranate juice. Subjects will drink eight     ounces of the pomegranate juice or placebo daily for twelve months.      The investigators expect the people receiving the pomegranate juice to show better cognitive     performance compared with those receiving a placebo after one, six, and twelve months. The     investigators believe cognitive decline and treatment response will vary according to a     genetic risk for Alzheimer's.      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects     will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to     rule out other neurodegenerative disorders linked to memory complaints.      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.     Following the first assessment, subjects will begin drinking the juice (either the     pomegranate juice or the placebo). Subjects will undergo a brief memory test at one-month     mark. At six months, subjects will have a second, full neuropsychological assessment. The     final assessment will take place at the end of the study, the 12-month mark. Additional blood     will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if     outcomes are positive.      In total, subjects will be expected to come to the University of California, Los Angeles     (UCLA) for 5 visits during the course of 12-13 months.   "
91140|NCT02093117|"     Background. Patients undergoing neurosurgical procedures experience higher rates of     postoperative respiratory failure compared to the broader surgical population.     Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be     beneficial. Despite this potential benefit, the effect of high levels of continuous airway     pressure on intracranial pressure, brain swelling and cerebral perfusion must be defined     prior to applying this intervention to the neurosurgical population.      Objectives. The primary objective is to determine the effect of an alveolar recruitment     maneuver on subdural pressure in patients undergoing supratentorial tumour resection. The     secondary objectives are to determine the effect of an alveolar recruitment maneuver on 1)     brain bulk score and 2) cerebral perfusion pressure in patients undergoing supratentorial     tumour resection.      Hypothesis. The investigators hypothesize that an alveolar recruitment maneuver of 30 cm of     water over 30 seconds will not result in a clinically-important (>3 mmHg) increase in     subdural pressure.      Methods. This single center, randomized, cross-over study will enroll 30 American Society of     Anesthesiogists Classification I-III patients scheduled to undergo supratentorial brain     tumour resection at Vancouver General Hospital. All patients will receive a standardized     general anesthetic including invasive blood pressure monitoring. After removal of the bone     flap, subdural pressure will be measured using a sterile 22-gauge plastic cannula. Brain bulk     will be assessed using a validated 4-point scale. After baseline arterial and subdural     pressure determination and brain swelling assessments, patients will be randomized to receive     either a recruitment maneuver of 30 cm of water for 30 seconds or a sham recruitment maneuver     of 5 cm of water for 30 seconds. Maximal subdural pressure and minimum MAP during the     maneuver will be noted, and the neurosurgeon will be asked to score the brain bulk. After a     2-minute equilibration period, the protocol will be repeated with the alternate group     allocation.      Statistical Analysis. Our sample size calculation, based on our primary outcome (subdural     pressure), determined that a sample size of 22 patients would allow us to detect a difference     of 3.5 mmHg in subdural pressure assuming a type I error of 0.05, a type II error of 0.2 and     two-sided significance testing. The subdural pressure during the recruitment maneuver as     compared to the sham maneuver will be analyzed using a paired t-test. The brain bulk score     will be compared using a Wilcoxon signed rank test. All data analysis will be performed with     STATA 12.1 (StataCorp, College Station, TX).   "
91141|NCT02093104|"     The purpose of this research study is to evaluate the quantitative information of utilizing     C-arm systems in liver tumor care in hopes this potential clinical combination of imaging     could aid in diagnosis and evaluation of tumor therapy.   "
91142|NCT02093091|"     This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer     (RMGI) -with a brand name of Ketac Nano- as a filling material for the treatment of caries     in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or     another conventional RMGI called Vitremer. Then, the treated children were evaluated at     baseline, after one yeat and after two years. The hypothesis to be tested in the present     study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary     molars will differ from that of its preceding conventional RMGI (Vitremer).   "
91143|NCT02093078|"     Crisis resource management represents the set of non technical skills, such as communication,     leadership, delegation, and prioritization, that allow effective teamwork for optimal patient     care during an urgent and critical situation. The Cognitive Aids with Roles Defined (CARD) is     a new concept of cognitive aid addressing the well-documented issue of teamwork in crisis     management. It relies on large identification cards specially designed for each team members     profession and role. During a life threatening clinical situation, the CARD protocol focuses     on clarification of individual roles and distribution of tasks for crisis management rather     than creating an additional algorithm identifying either a list of actions to be taken or the     dose of a medication. This study aims to evaluate the clinical impact of introducing the CARD     protocol in obstetrical emergency situations (code 333) in clinical practice at The Ottawa     Hospital.      Hypothesis: CARD protocol will: (i) decrease the total time taken to deliver the baby, and     (ii) improve clinical outcome for the mother and baby compared to traditional management     without the CARD protocol.   "
91192|NCT02092441|"     Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal     saline) pads to treat nausea in emergency department patients.   "
91144|NCT02093065|"     Abnormalities in the gene encoding Factor VIII (FVIII) results in hemophilia A, an X-linked     recessive bleeding disorder with a prevalence of 1 in 5000 males. Hemophilia A patients are     classified into 3 different categories based on residual FVIII activity compared to normal:     mild (6-40%), moderate (1-5%) and severe (<1%). This categorization correlates to some degree     with bleeding phenotype, but does not completely define it. Some patients with hemophilia A     bleed less often than others despite identical plasma FVIII levels. The cause(s) of this     phenotype heterogeneity in hemophilia A remains largely unknown, despite a number of studies     of possible factors.      Activated platelets, in addition to their role in primary hemostasis, play a major role in     secondary hemostasis (coagulation) by providing a phospholipid surface to which coagulation     factors bind. A role for platelets in the hemorrhagic propensity of hemophilia A has been     suggested in the past, but only a small number of studies have been performed with     limitations in assays performed and numbers of patients. The purpose of the present study is     to determine whether platelet reactivity in severe hemophilia A patients is associated with     past bleeding frequency and/or predicts future bleeding frequency.   "
91145|NCT02093052|"     This study will assess early and middle childhood outcomes of an intervention for neglecting     parents that was implemented in the children's infancy. We expect that parents who received     the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and     will follow children's lead more than parents who received a control intervention, and that     children will show better outcomes in attachment, inhibitory control, emotion regulation, and     peer relations than children of parents who received the control intervention.   "
91146|NCT02093039|"     The aim of this study is to assess the impact of a decision aid leaflet on the participation     of women invited to participate in the French national breast cancer screening program.   "
91147|NCT02093026|"     This study will assess the long-term safety and efficacy of repeat treatment courses of     rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug     (DMARD) inadequate responder population of participants who were previously randomized into     studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple     re-treatments until the protocol-defined end-of-treatment date (31 December 2011).     Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will     provide at least 7 years follow-up data on all participants initially randomized into WA16291     or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this     open label extension study from their respective feeder studies.   "
91148|NCT02093013|"     The investigators propose to implement and evaluate an integrated care program for enhancing     the care of patients with asthma in a region of Quebec province, Canada. The investigators     will implement our intervention in a family medicine group practice setting and plan to     deliver it to 150 experimental group subjects. The investigators will simultaneously study     300 control subjects who are receiving usual care in other regions of the province of Quebec.     Our hypothesis is that the program will improve the quality of life of patients with asthma     exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of     asthma, and a number of variables that relate to the conceptual model selected as a framework     for this study (the PRECEDE-PROCEED model of Green and Kreuter).   "
91149|NCT02093000|"     This prospective, open-label, single arm, non-interventional study will investigate the     effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who     previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.   "
91150|NCT02092987|"     The primary research question is which of the 2 best known dementia caregiver interventions,     the New York University Caregiver intervention (NYUCI) and Resources for Enhancing Caregivers     Health (REACH OUT), is more effective in alleviating depressive symptoms and caregiver burden     among Hispanic caregivers in New York City. The investigators hypothesize that the NYUCI will     be more effective than REACH OUT in reducing caregiver depressive symptoms and burden among     Hispanics because of its focus on family-centered counseling, which is posited to be more     important among Hispanic caregivers because of a cultural emphasis among Hispanics on family     interactions in interventions. In order to answer the primary question, the investigators     will conduct a pragmatic randomized trial comparing the NYUCI vs. REACH OUT in 200 Hispanic     caregivers of persons with dementia in the community of Northern Manhattan. The total time of     the intervention will be 6 months.      Our research question is which intervention, NYUCI or REACH OUT, is better in Hispanic     relative (any relative) caregivers of persons with dementia. Our objective is to obtain     effectiveness information that will help caregivers and health providers to make decisions     about which intervention to choose. Our primary aim is to compare the effectiveness of the     implementation of the NYUCI and REACH OUT in reducing depressive symptoms and burden. Our     exploratory aims are to examine and compare the predictors of effectiveness of the NYUCI and     REACH OUT and to examine additional outcomes such as caregiver stress and physical health,     and outcomes related to the person with dementia. METHODS. We will conduct a pragmatic     randomized trial of 200 relative caregivers of persons with dementia. Participants will be     randomized to the NYUCI or REACH OUT. The total duration of the intervention will be 6     months, with assessments at baseline and follow-up. All interventions and questionnaires will     be conducted in both English and Spanish. The study duration will be 3 years. The primary     outcomes will be changes in caregiver depressive symptoms, measured with the Geriatric     Depression Scale, and in caregiver burden using the Zarit caregiver burden interview.   "
93247|NCT02065531|"     The purpose of the current randomized clinical trial was to compare the effectiveness of     myofascial soft tissue release versus mobilization with impulse technique torsion (anterior)     on pain, disability, and kinesiophobia in individuals with chronic non-specific low back     pain.   "
91151|NCT02092974|"     The aim of this study is to assess whether the application of a selective serotonin reuptake     inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal     transcranial direct current stimulation (atDCS). For this, young and older healthy subjects     will be tested with a well established learning paradigm. Results of this study may help to     support the application of atDCS also in patients, e.g. with dementia or mild cognitive     impairment.   "
91152|NCT02092961|"     This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative     and more sensitive modalities for measuring the beneficial effects of syk inhibition with     fostamatinib in patients with active RA. This MRI sub-study was reported later than the main     study due to recruitment delays at specialist imaging sites and so is registered and     presented entirely separately to the main study results.      This study will investigate the impact of treatment on joint activity and damage by assessing     synovitis, osteitis, bone erosions and joint space narrowing.   "
91153|NCT02092948|"     The purpose of the study is to determine whether positron emission tomography (PET), using     the new imaging drug [124 I] PSCA-Minibody can be used for imaging prostate, pancreatic or     bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs,     etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate     Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder     cancers.   "
91154|NCT02092935|"     The purpose of this research study is to evaluate the safety and effectiveness of a new oral     antibiotic called SMT19969 in treating C. difficile Infection (CDI).   "
91155|NCT02092922|"     The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will     receive single-agent investigational study drug filanesib (ARRY-520). Patients will be     followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160     patients from North America and Europe will be enrolled in this study.      Eligible patients will have received at least two prior lines of therapy; have received prior     bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.   "
91156|NCT02092909|"     Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in     approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker     protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is     an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific     hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends     on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the     proliferation of cell populations responsible for the propagation of the disease.   "
91157|NCT02092896|"     The purpose of this study is to:      Part 1:      To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly     controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.      Part 2:      To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects     counterregulatory hormones and cognitive performance during hypoglycemia.   "
91158|NCT02092883|"     The purpose of this study was to investigate the presence of neuroinflammation in children     with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its     response to ACTH treatment by repeating the PK PET scan after treatment.   "
91159|NCT02092870|"     Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.   "
91160|NCT02092857|"     The immune system of newborn infants is immature with low activity of both innate and     acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary     fatty acids are one nutritional factor noted to play a role in immune function. The omega-6     long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA     (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The     balance or relative amounts of ARA and DHA have been associated with immune response. Some     commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and     DHA has not been determined with respect to immune function. This study will assess two     levels of ARA and the impact on immune response in healthy, term infants and whether genes     that influence essential fatty acid metabolism alter the nutritional requirement of infants.   "
91161|NCT02092844|"     The primary aim of the current study is to evaluate the effectiveness of a Cognitive     Behavioral Therapy intervention in the treatment of menopause-associated insomnia and     nocturnal hot flashes.   "
91162|NCT02092831|"     This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the     relative bioavailability of GDC-0941 administered as a single dose of the market image     formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the     Phase 2 formulation to healthy male and female volunteers. Participants will be randomly     assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation),     and GDC-0941 will be administered based on the assigned sequence. The study is expected to     last 8 weeks.   "
91163|NCT02092818|"     In accordance with the regulatory guidance this registry has been designed to collect     information about the long-term safety of Adempas in real clinical practice outside the     regulated environment of a controlled clinical study.   "
91164|NCT02092805|"     The purpose of this study is to assess the efficacy of rTMS over primary motor cortex in     patients suffering from malignant visceral pain. Thirty four patients were included in the     study. They are divided randomly into 2 groups using closed envelop as real rTMS group and     sham group. Real rTMS over the hand area of motor cortex (20 Hz, 10 trains with inter train     interval 30 second with total pulses 2000, intensity 80% of motor threshold) every day for     ten consecutive days (5 days/week) and the coil elevated and angled away from the head as     sham stimulation. Patients were evaluated by verbal descriptor scale (VDS), visual analog     scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st,     5th, 10th session, 15 day and 1 month after end of sessions. Serum human dynorphin (Dyn)     level was measured at baseline, 5th and 10th session.   "
91177|NCT02092636|"     An imaging method has been developed that uses near infrared light as an adjunct to     ultrasound for better diagnosis and for monitoring tumor response. This study will use a new,     non-invasive way to evaluate breast lumps using a low power light source & ultrasound to see     if breast lumps are benign or cancerous. This study will also evaluate if this new technique     might be useful in assessing response to chemotherapy.   "
91165|NCT02092792|"     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and     PK of escalating doses of DLYE5953A administered to patients with incurable, locally     advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I     study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected     patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety,     tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled     to further characterize the safety, tolerability, and PK of the proposed dose and schedule     for future studies.   "
91166|NCT02092779|"     Obesity is a disease not always attributable to nutritional imbalance, frequently associated     with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after     hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to     explore pituitary morphology and its association with pituitary function and metabolic     phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department     of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease     in a cross-sectional .   "
91167|NCT02092766|"     Delayed anaemia has been reported in European travellers with malaria cured by artesunate.     Although no deaths related to this delayed anaemia have been reported so far, blood     transfusion has been necessary in some affected patients. Recent observations suggest that     this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess     the incidence of late onset anaemia after treatment with intravenous artesunate compared to     intravenous quinine, to identify patients at risk and to clarify the causes of this delayed     anaemia.   "
91168|NCT02092753|"     The aim of the study is to analyze if a ketogenic diet (KD) compared to either a low     glycämic and insulinemic (LOGI) diet or to a standard diet (SD) is feasible, safe and     tolerable and will improve quality of life and physical performance in patients with Breast     Cancer during the rehabilitation phase.      It will be an open-label trial of nutritional intervention for 20 weeks spanning three     phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of     stationary intervention.   "
91169|NCT02092740|"     Retrospective analysis of treatment outcome and side effects of testicular cancer patients     that had been diagnosed at the University Magdeburg from 1960 until 2012.   "
91170|NCT02092727|"     The Southeastern Kidney Transplant Coalition is an academic-community collaboration between     partners in the kidney disease community who share the common goal of eliminating health     disparities in access to kidney transplantation among African American End Stage Renal     Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this     community-based coalition include patients with kidney disease, dialysis facility staff and     providers, transplant centers, quality improvement organizations, and patient advocacy     organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of     kidney transplantation is the lowest in the nation. Further, the investigators research     suggests that racial disparities in access to kidney transplantation are concentrated in the     Southeast, where African Americans are less likely to access each step in the transplant     process. The long-term goal of the investigators Coalition is to use community- based     participatory research approaches to develop, test, and disseminate sustainable, community     interventions improve access to transplant for African American patients with kidney disease.     The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study     proposes to use community-based participatory research methods to develop a multilevel     intervention to reduce racial disparities in access to kidney transplantation. The long-term     impact of this application will be to reduce racial disparities in the kidney disease     community.   "
91171|NCT02092714|"     This pilot research trial studies molecular analysis in tissue samples from patients with     advanced or metastatic neuroendocrine tumors. Studying samples of tissue from patients with     neuroendocrine tumors in the lab may help doctors identify mutations to classify disease and     plan the best treatment.   "
91172|NCT02092701|"     Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may     experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D     supplementation during one year can improve bone and muscle health in post-burn period.   "
91173|NCT02092688|"     This is a prospective observational trial that will enroll pregnant women between 24 and 36     6/7 weeks of gestation that present with signs and symptom of preterm labor with clinically     intact membranes and cervical dilatation ≤ 3 cm and a control group of pregnant women without     signs and risks for PTL to assess how the results of the novel kit for the detection of     PAMG-1 in both patient groups correlate to their time-to-delivery (TTD) and other adverse     neonatal and pregnancy outcomes.      Thes study hypothesis contains that the novel diagnostic kit will identify women who are at     high risk for preterm birth by a high positive predictive value.   "
91174|NCT02092675|"     The purpose of this study is to investigate the role of endothelial dysfunction in chronic     obstructive pulmonary disease.   "
91175|NCT02092662|"     The purpose of this study is to evaluate by objective measures the improvement in upper     extremity functioning, as reflection of motor learning, in stroke patients in the sub acute     phase. The investigators hypothesize that the improvements in daily functioning are partially     due to compensation strategies and partially due to motor learning.   "
91176|NCT02092649|"     Fatty acids are the main components of the cell membranes. It has been demonstrated that diet     can alter the characteristics and function of many membranes in the body, which has an effect     on cardiovascular and metabolic health. Over the last two decades there has been a     substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on     bodily function. There are two fatty acids that are of particular interest to researchers,     eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique     unsaturated structures, and their incorporation into biological membranes seems to generate     important and positive physiological effects. The body is unable to synthesize these fatty     acids in high concentrations to elicit significant effects, so they must be obtained through     diet in food or via supplementation.      It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR)     in humans, in part by increasing the use of fat as a fuel during rest. There are a limited     number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an     increase in RMR while others have found no change. These studies have some limitations, as     that they have either used a small sample size, a low omega fatty acid dose and/or short     supplementation periods. Due to the variable results, the investigators will improve the     reliability of the RMR measurements by making measures on each subject during two consecutive     days at each time point that it is measured (0, 6 and 12 weeks).      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3     supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The     researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR     and fat oxidation in some subjects and not in others. The duplicate RMR measures will     determine the prevalence and magnitude of the omega 3 supplementation.   "
91178|NCT02092623|"     Definition: To find out complications, objective and subjective outcomes of patients with     symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine     Finnish hospitals during September 2010 and August 2013. The study hypothesis is that     complications are acceptable and both objective and subjective outcomes are satisfying.   "
91179|NCT02092610|"     An international multicentre, open, comparative, parallel group, prospective clinical     investigation with a single 5 year follow up visit.   "
91180|NCT02092597|"     The purpose of this study is to assess the effects of incretin-based antidiabetic therapies     (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system     and to detail the mechanisms underlying their action in these systems.   "
91181|NCT02092584|"     The aim of this study is the comparison between the effects of supplementation with omega 3     or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in     patients with cardiovascular disease.   "
91182|NCT02092571|"     A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal     women   "
91183|NCT02092558|"     Background: Squamous metaplasia refers to the pathological transformation of the urothelium     leading to non-keratinised stratified squamous metaplasia (N-KSM).      Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM     of the urinary bladder in children.   "
91184|NCT02092545|"     Study to collect data on weight management on a male population of retired NFL athletes.   "
91186|NCT02092519|"     Background: EUS-guided fine needle aspiration (EUSFNA) is a well established technique for     tissue acquisition and diagnosis with excellent safety profile. The overall diagnostic yield     of EUSFNA exceeds 80%, with higher rates in EUSFNA of lymph nodes, where rates of >90% may be     expected, as compared to pancreatic masses, where lower diagnostic rates were reported. To     maximize the diagnostic yield, at least 3 needle passes are required for lymph nodes and at     least 4 passes for pancreatic masses. Olympus has recently made commercially available a new     22 gauge FNA needle (EZ Shot 2 with side port) with a side port at the needle tip. The     theoretical basis for introduction of the side port is to increase the diagnostic yield.     Preliminary unpublished retrospective data suggested the yield might be raised. However,     there are no prospective multicenter randomized controlled studies to ascertain the validity     of the assumption.      Aim: To determine whether there is a difference in diagnostic yield between EZ-Shot 2 and     EZ-Shot 2 with side port in patients with pancreatic masses for evaluation.      Methods: Patients with pancreatic masses referred for EUSFNA will be recruited prospectively     and randomized to either EZ-Shot 2 or EZ Shot 2 with sideport for the first puncture, and     then the alternative needle will be used for repeated punctured. The cytological and     diagnostic yield at first pass for both needles will be compared.      Clinical significance: This will determine whether the new needle design can further improve     the diagnostic yield of EUSFNA of pancreatic masses.   "
91187|NCT02092506|"     Triple therapy (TT) comprising proton pump inhibitor (PPI), amoxicillin 1g and clarithromycin     500mg twice daily has long been considered one of the standard treatment for H. pylori     infection as initial studies demonstrated success rates of > 90% on per protocol analysis     (PP) and > 80% on intention to treat (ITT) analysis. However increasing bacterial resistance,     especially to clarithromycin, has been reported and there are concerns that the efficacy of     TT has decreased. Sequential therapy (ST) is an alternative first line therapy that consists     of 5 days of treatment with a PPI and amoxicillin followed by 5-day treatment with the PPI     and clarithromycin and metronidazole. The rationale for this approach is that amoxicillin may     weaken the bacterial cell wall in the initial phase of treatment, and prevent the development     of drug efflux channels that inhibit clarithromycin from binding to ribosomes and thus help     to improve the efficacy of clarithromycin in the second phase of treatment. A recent     meta-analysis based on mainly European studies showed that the success rate of ST compared to     TT was 92.8 - 96% vs. 76.2 - 78.8%. Concomitant therapy (CT) is another alternative first     line treatment that consists of 10 days of PPI, amoxicillin, clarithromycin and     metronidazole. The rationale for using CT as a first line treatment option is to address the     possibility of clarithromycin resistance which is increasingly encountered in clinical     practice. Currently there are no randomized controlled studies that compared TT with ST in     Singapore, although both regimens are being used in routine clinical practice. The hypothesis     is that ST is superior to TT as first line treatment for H. pylori infection.      The study aim to compare 10-day TT versus 10-day ST versus 10-day CT as first line treatment     for H. pylori infection in Singapore.   "
91188|NCT02092493|"     ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which     provides real-time 3D image of the shape and configuration of the colonoscope as it travels     through the colon. Whilst it is being used in clinical practice in most units in the UK, it     is not a device which is routinely used on all lists, and most departments do not own enough     ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by     improving completion rates and times as well as patient comfort in selected endoscopists     (persons who perform the colonoscopy). However data on its benefit have been conflicting.      Subjective mental workload (the individuals mental resources required as a result of the     multiple demands placed on him/her from a task)in healthcare employees is known to be     important for the performance and safety of healthcare delivery. Increased workload during     task performance may increase fatigue, facilitate errors and lead to overall inferior     performance.      In colonoscopy high mental workload could potentially be responsible for longer procedural     time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor     technique leading to patient discomfort. The effect of the endoscopist mental workload on     their performance and potential facilitators to reduce mental workload is an area that has     been neglected in this field.      This study aims to look at the mental workload of endoscopist during colonoscopy and the     effect ScopeGuide may have on this workload.      Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the     endoscopist performing the procedure   "
91203|NCT02092298|"     The goal of this clinical research study is to learn if hyperthermic intraperitoneal     chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or     gastroesophageal cancer. The safety of this treatment will also be studied.   "
91189|NCT02092480|"     The If I Were Jack feasibility trial will test the acceptability and feasibility of using and     evaluating a unique and scientifically informed educational resource on the topic of teenage     men and unintended pregnancy in post-primary schools in Northern Ireland. The study is being     conducted by a multidisciplinary team at Queen's University Belfast with collaborators and     will begin in May 2014. It is a phase II feasibility trial with an embedded process     evaluation, twenty four months in duration. The research will assess the feasibility and     acceptability of the intervention and trial methods, and provide estimates for a phase III     cluster randomised trial, including potential effect sizes and recruitment, retention and     participation rates, so that the feasibility and optimal design of a full-scale trial can be     ascertained. It will include an analysis of the costs of delivering the intervention and a     process evaluation using a mixed-methods triangulated design to determine the acceptability     of the intervention and research measures to participants and to establish fidelity to     implementation protocol. Additionally, it will assess variation in normal practice of     Relationship and Sexuality Education in participating schools in relation to teenage     pregnancy.   "
91190|NCT02092467|"     This post-marketing study is designed to compare the safety of tofacitinib versus TNF     inhibitor with respect to major cardiovascular adverse events and malignancies, excluding     non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety     events, including non-melanoma skin cancers, hepatic events, infections, and efficacy     parameters will be collected and evaluated in the study.   "
91191|NCT02092454|"     To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain     relief associated with acute otitis media.   "
91193|NCT02092428|"     Investigators at the Biomedical Imaging Research Institute (BIRI) at Cedars-Sinai Medical     Center have developed a Magnetic Resonance Imaging (MRI) method for imaging coronary arteries     using slow-infusion, contrast-enhanced data acquisition. This method allows faster data     acquisition and better spatial resolution.      Specific aims of this study are to:        1. compare coronary artery imaging with and without contrast media on both healthy subjects          and patients;        2. assess the accuracy of coronary MRI in detecting coronary artery disease as compared to          conventional x-ray angiography      Researchers hypothesize that contrast-enhanced MRI will improve the delineation of coronary     arteries over non-contrast-enhanced MRI and that optimized, contrast-enhanced coronary MRI     technique will accurately detect coronary artery disease (CAD) as compared to conventional     x-ray angiography.   "
91194|NCT02092415|"     The goal of this study is to use contrast enhanced ultrasound to determine the degree to     which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced     ultrasound is performed to quantify thigh and calf perfusion at baseline and during     application of the JT   "
91195|NCT02092402|"     The purpose of this study is to investigate the effect of fecal microbiota transplantation     (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.   "
91196|NCT02092389|"     The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients     under adalimumab therapy and the correlation with their general wellbeing (Quality of Life     [QoL]), workability, and disease activity.   "
91197|NCT02092376|"     The aim of the study is to increase vitamin D concentrations or to keep it on high level,     respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the     overall health status in bariatric patients. In this project, the vitamin D status, the     parameters of inflammation, bone turnover, insulin resistance, liver and depression score of     bariatric patients are expected to improve, due to supplementation of a loading dose compared     to the standard therapy.   "
91198|NCT02092363|"     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and     PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered     IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL •     min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of paclitaxel and     carboplatin will be given. Additional cycles may be given as per institutional standard of     care after discussion with the Medical Monitor. Treatment with OMP-54F28 will continue after     completion of treatment with paclitaxel and carboplatin. The planned dose levels of OMP-54F28     are 5 and 10 mg/kg.   "
91199|NCT02092350|"     This study will evaluate the safety and efficacy of combination treatment with grazoprevir     (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic     Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The     primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within     the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained     viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.   "
91200|NCT02092337|"     Computer-assisted speech training is a speech recognition training system developed for     cochlear implant users. With minimal facilities and skills, cochlear implant users can     conduct this training at home. The purpose of this study was to apply this system to     adolescent and young adult hearing aid users with prelingual severe to profound hearing loss.   "
91201|NCT02092324|"     This phase II trial studies how well ruxolitinib phosphate works in treating patients with     chronic neutrophilic leukemia (CNL) or atypical chronic myeloid leukemia (aCML). Ruxolitinib     phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for     cells to reproduce. This trial also studies the genetic makeup of patients. Certain genes in     cancer cells may determine how the cancer grows or spreads and how it may respond to     different drugs. Studying how the genes associated with CNL and aCML respond to the study     drug may help doctors learn more about CNL and aCML and improve the treatment for these     diseases.   "
91202|NCT02092311|"     The purpose of this study is to determine the rates of major post-varicocelectomy     complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new     method named Combined Mini-incision Microscopic Varicocelectomy. The study hypothesis is that     using this method will lead to less major complications of recurrence, hydrocele, and also     less incidental injuries to the arteries that will result less testicular atrophy   "
91205|NCT02092272|"     Patients will be randomly assigned to one of two groups using a random number generator.     Group 1 will be provided with in-office instruction of standard of care eccentric exercises     for rotator cuff tendinopathy. Group 2 will be provided with in-office instruction as well as     a instructional exercise video source (DVD) to take home as a reminder on how to perform two     specific standard of care eccentric exercises for rotator cuff tendinopathy. Each group will     be given a card to track adherence to the standard of care eccentric exercise routine as     measured only by the days that they accomplish their exercises. Study exercise diary will be     collected after 12 weeks of treatment. Eccentric exercises are taught as part of standard of     care for rotator cuff tendinopathy.   "
91206|NCT02092259|"     The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for     the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic     patients.      The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.   "
91207|NCT02092246|"     To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in     obese patients with no clinically detectable effusion.   "
91208|NCT02092233|"     The ARIES HSV 1&2 Assay is a PCR based test for the direct detection and typing of herpes     simplex virus (HSV 1 & 2) DNA.      The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay.   "
91209|NCT02092220|"     This study will test the hypothesis that a wearable bionic pancreas system that automatically     delivers insulin and glucagon can provide superior regulation of glycemia vs. usual care for     adults with type 1 diabetes.      Please note that all participants must work or attend school at one of the following     campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical     Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University     in Palo Alto, CA.   "
91210|NCT02092207|"     This is a controlled study to determine the effectiveness and safety of KL7016 in the     treatment of adult patients with dry eye syndrome (DES).   "
91211|NCT02092194|"     Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The     supported mechanism is the improved clearance of uremic toxins by convective transporter.     However, It has not been elucidated which convection volume is optimal, especially in Asia. A     total of 60 participants receiving conventional hemodialysis will be randomly assigned to     receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or     standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of     serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes     will include changes in the nutritional markers, inflammatory markers, and blood pressure     from baseline to after treatment.      This would be the first multicenter prospective, randomized controlled trial to determine     whether large convective volume improves the treatment efficacy in Korean patients undergoing     post-dilution online HDF.   "
91212|NCT02092181|"     The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in     treating symptoms of Overactive Bladder in people with Parkinson's Disease.   "
91213|NCT02092168|"     The purpose of this study is to determine the effects of age on the pharmacokinetic (PK)     profile of BIA 9-1067 and its metabolites.   "
91214|NCT02092155|"     Some patients that have a tunneled pleural catheter will not have the pleural fluid (water     around the lung) return after some time (pleurodesis). The purpose of this study is to     understand how the investigators can predict who will achieve pleurodesis and how this occurs     by studying the pleural effusion.   "
91215|NCT02092142|"     The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated,     Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated     personnel.   "
91216|NCT02092129|"     Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We     hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have     prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic     patients. The aim of this study is to examine glucose metabolic outcome in acromegalic     patients with and without histologically verified prolactin and growth hormone (GH)     co-secreting adenomas. The study population include 79 patients who have all undergone     surgical treatment for acromegaly.   "
91217|NCT02092116|"     The REDUC trial's objective is to address one of the core issues with the treatment of HIV,     which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are     unaffected by conventional HIV medication and invisible to the immune system. HDACi have the     potential to activate these latently infected cells. This will make the HIV infected cells     visible to the immune system; the immune response generate by Vacc-4x will be able to attack     and eliminate the infected cells.   "
91218|NCT02092103|"     This is a randomized controlled trial that will compare the effects of delayed umbilical cord     clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The     infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be     evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage,     and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping     is superior to simply delayed cord clamping, presumably providing an increased blood volume     to the preterm neonate improving its outcomes.   "
91219|NCT02092090|"     The study is a large scale cluster randomised trial to evaluate the effects of sodium     reduction based upon the use of salt substitute on the risk of stroke defined as the     occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested     is that sodium reduction will have no effect upon stroke risk. The secondary objectives are     to determine effects of sodium reduction on major vascular events and total mortality.   "
91220|NCT02092077|"     The purpose of this study is to support selection of an appropriate safe and efficacious dose     for study in further development.   "
91221|NCT02092064|"     to investigate the effect of basal proteinuria on pregnancy outcomes of patients with     Familial Mediterranean fever (FMF).   "
91300|NCT02091037|"     The purpose of this study is to characterize the bacterial strains that colonize children     with atopic dermatitis.      The investigators hypothesize that rectal cultures will be more sensitive than anterior nares     cultures for detecting S. aureus colonization, and that strains of S. aureus colonizing     patients with atopic dermatitis will be resistant to commonly used topical antibiotic     ointments.   "
91222|NCT02092051|"     Breif summary      A keystone in preventing diabetic complications in patients with type 1 diabetes is good     glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels has been an     essential part of insulin dosing before meals. However, in recent years continuous glucose     monitoring (CGM) has become a treatment option for notifying the patient on trends in glucose     levels and warning when these are estimated to be too high and too low.      In some countries today, Sweden among others, CGM is reimbursed in combination with     continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control     or a history of repeated severe hypoglycaemia in adult type 1 diabetic patients. This is     based on existing clinical trials showing a beneficial effect on HbA1c by combining CGM with     CSII. However, the majority of adult type 1 diabetic patients are treated with multiple daily     insulin injections (MDI). Clinical trial data are sparse on the effect of CGM in adult type 1     diabetic patients treated with MDI, and there are no clinical trial data including only     patients on MDI.      The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction     among adult type 1 diabetic patients on CGM treated with MDI. The design is a 69-week,     cross-over clinical trial, including 26 weeks treatment with CGM, 26 weeks treatment with     conventional SMBG and a wash-out period of 17 weeks. In total 120 patients will be included     at 8 sites in Sweden. The study will have 80% power to detect a 3 mmol/mol (0.3 percentage     unit) change in HbA1c resulting from CGM.   "
91223|NCT02092038|"     Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and     radiation therapy, followed by surgery and then further temozolomide.   "
91224|NCT02092025|"     The purpose of this study is to evaluate the safety and efficacy of long-term use of     azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical     setting.   "
91225|NCT02092012|"     The aim of this study is to investigate comparison of preemptive analgesic effects of     dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal     hysterectomy.   "
91228|NCT02091973|"     The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as     nephrotoxicity. However, these drugs are essential for kidney transplant especially in high     immunological risks. To date, however, there is an alternative regimen by using of     everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms.     Of note, this study aims to evaluate the toxicity by using microRNA profiles detection     between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney     transplantation.   "
91230|NCT02091947|"     Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous     systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve     near the third sacral root induces relaxation of the detrusor muscles and reinforcement of     urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on     stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term     effect of this method on stress urinary incontinent patients.   "
91231|NCT02091934|"     The purpose of the study is to compare the results of PRKK surgery when using     wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser     treatment in patients with nearsightedness with and without astigmatism   "
91232|NCT02091921|"     Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb     loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a     major cause of death and disability (secondary to myocardial infarction, stroke and     amputation). The mortality in patients with CLI approaches 13-25% and 50% at one and five     years respectively. High on-treatment platelet reactivity (HPR) in patients treated with     aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events     after percutaneous coronary interventions and coronary syndromes. Preliminary studies suggest     that the prevalence of HPR in patients with critical limb ischemia treated with aspirin and     clopidogrel is as high a 78.5%. In patients with coronary artery disease ticagrelor overcomes     non-responsiveness to clopidogrel. However, the antiplatelet effect of ticagrelor in patients     with critical limb ischemia is unknown.   "
91233|NCT02091908|"     Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18     through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying     medical conditions.   "
91234|NCT02091895|"     The aims of this research are to validate and develop of therapeutic strategies for patients     with colorectal lesions in real time through pCLE(probe-based confocal laser endomicroscopy).     Endomicroscopy is a technique for obtaining histology-like images from inside the human body     in real-time. Total objections are 311 patients.      Specific research topics are as below.        1. Diagnosis and classification of colon polyps through pCLE        2. Evaluation of the depth of invasion of colorectal cancer or lateral growth type tumor          through the pCLE        3. Differential diagnosis of colorectal submucosal tumor through the pCLE        4. Differential diagnosis of ileocecal ulcers through the pCLE      The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict     of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological     findings of lesions Check diagnostic agreement of technical phrases which are derived, the     matching degree between observers, and will develope a new classification method based on     this.   "
91235|NCT02091882|"     The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System     by completing a series of Patch applications and IEM ingestions in the clinic.   "
91236|NCT02091869|"     The purpose of this study is to see if using a mobile phone application asthma action plan     will help improve asthma management.   "
91237|NCT02091856|"     Project aim: To compare the effectiveness and acceptability of a conventional and a religious     internet-supported cognitive behavior therapy (iCBT) for depression in Romania.   "
91238|NCT02091843|"     Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans     returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage     of patients will fail to improve and will develop chronic treatment-resistant PTSD. Patients     suffering from PTSD experience intense suffering, lack of productivity and a higher risk of     suicide. Unfortunately, combat PTSD has a tendency to be resistant to current treatments.      The central goal of this project is to develop a new therapeutic strategy involving the     placement of intracranial electrodes to treat the symptoms of PTSD. The project is based on     recent evidence showing abnormal activity in a specific brain region of PTSD patients,     thought to be responsible for the core symptoms of PTSD.   "
91239|NCT02091830|"     The purpose of this study is to assess whether radiographic osteoarthritis severity (OA;     Kellgren-Lawrence scale) is associated with self-reported improvement in pain after     non-surgical treatments (physiotherapy, pain killers, injection, other treatments).      The hypothesis is that radiographic OA severity is inversely associated with self-reported     improvement.   "
91240|NCT02091817|"     The purpose of this study is to determine whether oxytocin affect face perception   "
91241|NCT02091804|"     The purpose of this study is to to conduct a randomized controlled trial comparing an     intervention group and a control/wait list group to evaluate the feasibility of the Promoting     First Relationships method in an American Indian community through their tribal Maternal and     Child Health program, and to assess the efficacy of the method in this community.   "
91242|NCT02091791|"     The aim of this study is to compare two levels (high and low forces) of short term lumbar     traction on pain and functional tests of the lower limbs in a specific population of patients     presenting with acute lumbar sciatica secondary to disc herniation. The investigators     hypothesize that, in this particular medical condition, high level of lumbar traction might     be more effective than low level lumbar traction in decreasing the pain associated with acute     sciatica.   "
91243|NCT02091778|"     The primary objective of this post market clinical follow-up (PMCF) investigation is to     evaluate performance and safety of fast gelling dressing when used as intended in Diabetic     Foot Ulcer (DFU).      The primary endpoint will be Changes from baseline in the condition of the peri-wound skin     measured by the following variables; maceration, redness/irritation, rash/eczema, blistering,     dermatitis, skin stripping, trauma to wound edges and product degradation on the skin   "
91244|NCT02091765|"     The purpose of this study is to evaluate the efficacy and cost-effectiveness of an     internet-based cognitive behavioural therapy program in alleviating problems with intimacy     and sexuality in women treated for breast cancer.   "
91248|NCT02091713|"     Emerging evidences indicate that performance on a variety of functional movement screens can     identify athletes/soldiers at risk for injury. These field expedient tests have not been     validated in a military setting or across different military occupational specialties. In     this prospective study the investigators plan to screen 300 combatants for a 1-year time     frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable     risk factors which are hypothesized to predict injury risk during the military service.   "
91249|NCT02091700|"     To develop a database of the peripheral choroidal circulation using ultra widefield (UWF)     imaging. This database will serve as a quantitative reference tool for the comparison of     subjects to a database of known normal subjects.   "
91250|NCT02091687|"     Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who     previously participated in a randomized, controlled trial (RCT) of intensive therapy combined     with repetitive Transcranial Magnetic Stimulation (rTMS)   "
91251|NCT02091674|"     To determine the efficacy and safety of hyaluronic acid (AdantTM, Tedec-Meiji Farma SA) for     acute ankle sprain, a single-site, open-label, controlled trial will be conducted.      The study will be conducted in a sport-medicine clinical research center in London, Ontario,     Canada. The eligible patients will be 18 years of age and older, have first or second degree     lateral sprain within 48h of the start of the treatment, and moderate or severe pain (>45mm     on 100 mm pain visual analogue scale /VAS). Exclusion criteria will include bilateral ankle     sprain, ipsilateral knee trauma, prior sprain in the past 6 months, use of NSAID prior to     entry, intra-articular ankle injection in the prior 6 months.      The patients will receive standard care (RICE and rescue analgesics), and a single 2.5cc     Adant periarticular ankle injection following provision of informed consent and collection of     baseline data. NSAIDs, corticosteroids or topical analgesics will not be allowed.      Assessments will be done at baseline, days 8, 30 and day 90. Efficacy measures will include     patient's pain VAS on weight bearing (0-100mm) and walking 20m (0-100mm), patients' global     assessment of ankle injury (5 point categorical scale), patients' assessment of normal     function/activity (5 point categorical scale), physician's global assessment of ankle injury     (5 point categorical scale), patients/physician satisfaction assessment (10 point categorical     scale), time to return to pain-free and disability-free sport and adverse events as per WHO     definition.      It is expected that the Hyaluronic acid injections will decrease pain and swelling, promote     healing, improve time to return to sport and increase mobility.   "
91252|NCT02091661|"     The purpose of this study is to evaluate the effectiveness of the two most established     primary treatments for patients with clinically localized prostate cancer: radical retropubic     prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical     disease-free survival, overall survival, and prostate cancer-specific survival. As secondary     objectives quality of Life impact of treatments' side effects will be also assessed.   "
91301|NCT02091024|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.   "
91253|NCT02091648|"     The purpose of the proposed study is to conduct a randomized controlled pilot trial of a     school-based stress management and coping skills training program among a sample of     economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed     asthma. The investigators aim (1) to establish feasibility of this approach by recruiting     from different schools and (2) to learn whether individuals assigned to receive the     intervention show improvements in psychological function, decreases in lung inflammation, and     related improvements in asthma health when compared with disease severity-matched peers who     receive education-only or standard care.   "
91254|NCT02091635|"     Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal     pain or discomfort in the absence of a specific structural cause. Improving gastric     accommodation and prokinetic effect seem to be an attractive physiological target in patients     with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in     December 2011 in Korea for treating patients with FD. The current study aims to evaluate     effects of motilitone on gastric accommodation and emptying after a meal in a group of     healthy volunteers using three-dimensional gastric volume measurements by magnetic resonance     imaging (MRI). Healthy volunteers are randomly allocated to receive either motilitone or     placebo in a double blinded manner. After 5 days of treatment, subjects undergo gastric MRI.     The primary endpoint is gastric accommodation.   "
91255|NCT02091622|"     Introduction: Honest prognostication and information for patients are important parts of     end-of-life care. This study examined whether an educational intervention could increase the     proportion of patients who received information about the transition to end-of-life care     (ITEOL).      Method: Two municipalities (in charge of nursing homes) and two hospitals were randomized to     receive an interactive half-day course about ITEOL for physicians and nurses. The proportion     of patients who received ITEOL was measured with data from the Swedish Register of Palliative     Care (SRPC). Patients were only included if they died an expected death and maintained their     ability to express their will until days or hours before their death. Four hospitals and four     municipalities were assigned controls, matched by hospital size, population, and proportion     of patients receiving ITEOL at baseline.   "
91256|NCT02091609|"     This aim of this study is to compare different oral hygiene aids for the ability to remove     plaque in patients who went through dental implant treatment and are currently on a     maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba,     Faculty of Dentistry.   "
91257|NCT02091596|"     This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50     enrolled subjects. Adult subjects (greater than 18 years old) who present with a mildly     infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis     but not involving joint capsule, tendon, and bone). Subjects must also provide informed     consent and meet all other entry criteria to be enrolled and randomly assigned to receive     PluroGel N or PluroGel vehicle.   "
91258|NCT02091583|"     The purpose of this study is to examine the effects of consumption of a novel food supplement     consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives,     including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and     soluble dietary fibre, aiming at the management of heart disease risk factors in people with     metabolic syndrome and to test its efficacy and safety in humans.   "
91262|NCT02091531|"     This is a phase II study which will test the study drug MLN0128 in patients with castration     resistant prostate cancer who have received chemotherapy in the past. Phase II clinical     trials test how well an investigational drug works in treating a specific cancer.     Investigational means that the drug is still being studied and that research doctors are     trying to find out more about it. MLN0128 is not approved by the FDA.      The purpose of this study is to see what effects (good and bad) the study drug MLN0128 has on     the patient and the cancer. MLN0128 is a drug that belongs to a class of drugs called mTOR     kinase inhibitors. A protein, called mTOR inside the cells in the body, plays a role in     controlling how cells grow. In some cancer cells, mTOR may be over-active. This over-activity     may cause some cancer cells to grow out of control. Research has shown that mTOR inhibitors     can block this overactivity and may help stop or slow down the growth of some types of cancer     cells.   "
91263|NCT02091518|"     Magnetic resonance imaging (MRI) is a diagnostic imaging method with constant progress and     improvement in the way the MRI images are obtained. Many of these advances involve changes to     MRI software and hardware. The goal of this study is to find out the possible benefits of new     MRI techniques. This will allow us to use the new MRI methods in research and patient care.   "
91264|NCT02091505|"     Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis     (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion     (CRVO). However, there is little information on whether there are any predictive factors of     treatment outcome after this treatment. We plan to perform comprehensive functional and     imaging tests to determine significant predictive factors.   "
91265|NCT02091492|"     This study will test the hypothesis that daily subcuaneous administration of 20µg of     teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates     proximal 2-segment humerus fracture healing and improves the three dimensional structural     properties of bone as measured via quantitative bone image analysis and finite element     modeling assessed by quantitative computed tomography.   "
91266|NCT02091479|"     In patients with a high thromboembolic risk, withdrawing anticoagulant treatment is     recommended in some situations, including when major hæmorrhage occurs. But withdrawing     treatment can be risky. In patients on a curative dose of anticoagulant medicine, treatment     withdrawal heightens the risk of thromboembolic events occurring, with potentially major     consequences. For instance, mechanical valve thrombosis is fatal in 15% of patients.     Resumption of anticoagulation is therefore critical in patients at high risk for     thromboembolic events.      However, in these patients having presented major hæmorrhage, resumption of anticoagulation     heightens the risk of hæmorrhage recurrence. This risk is even higher when the original     hæmorrhage was not accessible via surgical, endoscopic or endoluminal hemostasis.      As far as investigators know, there is no data in the literature to rely on when the major     hæmorrhage is not accessible via hemostatic intervention and the risk of thrombosis is high.     When confronted with patients who need anticoagulation but have a high risk of hæmorrhage     recurrence, the question of when treatment should be resumed has not been resolved. This is     why investigators propose to conduct a randomised comparative study to evaluate two treatment     strategies - early resumption (H48 to H72) versus late resumption (H120 to H144) of     anticoagulation.      MAIN OBJECTIVE: The main objective of the present study is to evaluate in terms of bleeding     risk, thrombosis risk and mortality at one month, the effect of early vs. late resumption of     anticoagulation in patients having presented with serious hæmorrhage while on curative-dose     anticoagulants and facing a high thromboembolic risk.   "
91267|NCT02091466|"     Background: Hypothermia is common during general and regional anesthesia even when active     warming measures are taken. The existing literature shows that, in pregnant patients, the use     of forced air-warming during cesarean section under spinal anesthesia does not prevent     maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming     system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in     pregnant women subjected to elective cesarean delivery.      Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal     anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal     gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the     preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery.     After the anesthesia, the thermal gown was moved from the regular position and placed over     the chest and upper limbs, as an upper body blanket, and maintained throughout the study. The     following variables were observed: preoperative and operative room temperature, hemoglobin     saturation, heart rate, arterial pressure, tympanic temperature in the preoperative care unit     room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal anesthesia. Repeated Measure     ANCOVA compared temperatures of each group, adjusted for baseline values.   "
91268|NCT02091453|"     Background: To study intensive targeted cognitive rehabilitation of attention in the acute     (<4 months) and subacute rehabilitation phases (4 -12 months) after acquired brain injury and     to evaluate the effects on function, activity and participation (return to work).      Design: prospective, randomised, controlled study. Methods: 120 consecutive patients with     stroke or traumatic brain injury are randomised to 20 hours of intensive attention training     by Attention Process Training or by standard, activity based training. Progress is evaluated     by Statistical Process Control and by pre and post measurement of functional and activity     levels. Return to work is also evaluated in the post-acute phase. Primary endpoints are the     changes in the attention measure, Paced Auditory Serial Addition Test and changes in work     ability. Secondary endpoints include measurement of cognitive functions, activity and work     return. There are 3, 6 and 12-month follow ups focussing on health economics.      Discussion: The study will provide information on rehabilitation of attention in the early     phases after acquired brain injury (ABI); effects on function, activity and return to work.     Further, the application of Statistical Process Control might enable closer investigation of     the cognitive changes after acquired brain injury and demonstrate the usefulness of process     measures in rehabilitation.   "
91269|NCT02091440|"     The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in     patients listed for cardiac transplantation with refractory, advanced heart failure at risk     of death.   "
97171|NCT02013310|"     This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group     study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in     subjects with Age-Associated Memory Impairment (AAMI)   "
91270|NCT02091427|"     Acute myocardial infarction (AMI) is defined by an increase and/or decrease in the     concentration of cardiac troponin, with at least one value above the 99th percentile value of     the reference population together with evidence of ischemia. An objective tool to determine     the magnitude of the cardiac troponin change is the use of reference change values (RCV). The     basis for this tool is that, for a change to be significant, the difference in serial results     must be greater than the inherent variation in two test results. The inherent variation of a     laboratory test result is composed of analytical and within-subject biological variation. An     important requirement to use RCVs is that the concentrations of cardiac troponins fluctuate     randomly around a homeostatic set point in cardio-healthy individuals. Verification of this     important condition has never been performed, and violation of this condition would preclude     the use of RCV's in clinical practice.   "
91271|NCT02091414|"     This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in     combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and     steroids, in patients receiving a heart transplant. The anticipated time on study treatment     is 24 weeks.   "
91272|NCT02091401|"     The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate     administered by the Springfusor® controlled pump to a continuous intravenous regimen. The     goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum     magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the     continuous intravenous and Springfusor repeat bolus regimens. The study will also document     the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.   "
91273|NCT02091388|"     This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well     as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat     injections   "
91274|NCT02091375|"     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children     and young adults with Dravet syndrome.   "
93790|NCT02058459|"     The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in     patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a     similar safety profile and improved physiological and functional outcomes to a sham-control.   "
91275|NCT02091362|"     The main purpose of the trial is to determine the effect of a study drug known as LY2409021     on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when     compared to placebo. The study has two periods. Each participant will receive LY2409021 or     placebo in each period. At least 4 weeks will pass between periods. The study will last about     23 weeks for each participant. Participants may remain on stable dose metformin, as     prescribed by their personal physician.   "
91276|NCT02091349|"     The objective of this study is to determine the tolerance and utilization of polydextrose and     soluble corn fiber through analyses of fecal samples of fermentative end-products     (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.   "
91277|NCT02091336|"     The aim of this study is to determine the efficacy of oral treatment with glyburide and     metformin controlling excessive fetal growth in women with gestational diabetes, using     insulin as a ransom on no response to oral treatment .      It is randomized with women who seek care at the Outpatient Diabetes in Pregnancy in our     hospital trial Eligible women between 18 - 45anos diagnosed with gestational diabetes ,     according to the WHO criteria , ratified the public network for prenatal care at the Clinic     for Diabetes and Pregnancy HCPA .      Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of     enrollment.      Pregnant women with indication for pharmacological treatment will be invited to randomization     to use of oral , glyburide or metformin antidiabetic .      At regular intervals of 2 - 3 weeks fetal growth will be measured with obstetric     ultrasonography , until birth.      The primary outcomes will be :      ( 1 ) weight and gestational age at birth and the index of large for gestational age fetuses     ( ≥ 90th percentile for gestational age ) ( 2 ) the use of insulin to achieve glycemic     targets according to fetal growth , as an indirect measure of the inefficiency of oral     medications .   "
91278|NCT02091323|"     The effect of roux-en-Y gastric bypass(RYGB) on patients with type 2 diabetes mellitus(T2DM)     and a body mass index(BMI)>35kg/m2 is clear. There are large-scale patients with T2DM in     Chinese population and currently about two-thirds of them are lack of adequate blood glucose     control. Asian Chinese have different type of obesity, different style of diet, and a     relatively low BMI levels as well. We assess the feasibility and efficacy of laparoscopic     roux-en-Y gastric bypass surgery (LRYGB) in patients with non-severely obese T2DM.Taking into     account the differences of body size and diet between the United States & Europe and Asian     countries, diabetic situation has its special features in different regions, especially in     Asia China. Asian Chinese have a high incidence of T2DM and a relatively low BMI levels.     Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body     mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become     necessary.The patients will be followed up for one year after surgery and a comparison would     be made between the two groups. Clinical indicators that reflect the effect of LRYGB are     monitored before surgery and 1, 3,6,12 months after surgery. Complete remission of diabetes     was defined by hemoglobin A1c (HbA1c)<6.0% and Fasting plasma glucose (FPG)<5.6mmol/L.   "
91279|NCT02091310|"     In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase     I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating     its effect on QT/QTc prolongation in healthy male and female subjects. According to the     guidelines, such studies should typically be performed at the expected therapeutic dose and a     supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.      GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy     overweight subjects (study GFT505-111-7), and both safety and tolerability were very good.     However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d.     Therefore, the current TQT study will be preceded by a multiple ascending dose study in which     the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding to 2.5     and 3 times the expected therapeutic dose will be evaluated. The highest dose level for which     safety and tolerability are considered satisfactory will be the supra-therapeutic dose used     in the TQT study.   "
91280|NCT02091297|"     More and more women are on buprenorphine or methadone during pregnancy for a history of     opioid addiction. Currently, pain control after cesarean section for women already on these     medications, if they need operative delivery, is a challenge due to the pharmacology of those     drugs. They have higher pain scores and 45-47% higher opiates requirement. To improve pain     control, some unique regional anesthesia techniques have been employed, besides opioid and     non-opioid medication management through the oral, intravenous, and/or neuraxial (spinal or     epidural) route. One is a TAP block ( transversus abdominis plane block), a regional     anesthesia procedure in which long acting local anesthetic, such as ropivacaine, is injected     on both sides of the patient's abdomen to numb the nerves supplying the abdominal wall, or     the surgical site. Another is a patient - controlled epidural, a small flexible catheter that     is inserted in the back into the epidural space near the spine, which bathes the spinal nerve     roots with long acting local anesthetic, such as bupivacaine, and with an opioid, such as     fentanyl, to numb the nerves going to the surgical site. Through an epidural pump, the     patient receives a continuous infusion of local anesthetic and can delivery more medication     as needed through a bolus feature. There have case reports, or case by case accounts, of     these techniques, and it is suspected these techniques result in better pain control with     minimal side effects. No clinical, human or animal, has evaluated these techniques in a     controlled and through manner, either comparing the two techniques to each other or comparing     them to the common care of opioid and non-opioid medication management through the oral,     intravenous, and/or neuraxial route, including neuraxial hydromorphone or morphine.   "
91281|NCT02091284|"     In this study, eligible alcoholic inpatients recruited from a specialized clinic for     addiction treatment, filling inclusion criteria and not showing any exclusion criteria, will     be randomized to receive the repetitive (5 sessions, every other day) bilateral dorsolateral     Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for     20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine will be examined before     (baseline), during and after the end of the tDCS treatment. Other clinical outcomes, and also     visual P3 event-related potential and neuroimagings exams will be also performed before and     after treatment.      Based in our previous data, our hypothesis is that repetitive bilateral tDCS over dlPFC will     favorably change clinical, cognitive and brain function in alcoholism and these will be     long-lasting effects.   "
91282|NCT02091271|"     The National Institute on Aging (NIA) Intramural Research Program (IRP) has a number ofiRB     approved research studies involving human subjects, both normal volunteers and patients. As a     means of identifying interested volunteers and other participants in the research process,     this screening mechanism is established to identif'y potential eligible participants for NlA     protocols.      To participate, volunteers/patients must meet the specific requirements of at least one of     the available NlA research studies; this protocol serves as a first step for admitting     volunteers/patients to an appropriate approved protocol and creating a contact database for     approved NlA studies.      This protocol will facilitate their recruitment into NIA approved studies and provide NlA     staff the opportunity to examine subjects where diagnostic observations can be documented and     evaluated for research potential.   "
91283|NCT02091258|"     Tooth loss in periodontitis patients is associated with patient and site factors as well as     with treatment provided. Not much is known about long-term tooth loss in periodontitis     patients in private practice in the UK. The study plans to follow-up 200 subjects with     periodontitis (and currently on maintenance therapy) for 5 years. The effect of treatment     provided, site and patient risk factors on tooth loss will be studied.   "
91284|NCT02091245|"     This research study involves participants who have acute lymphoblastic or acute myelogenous     leukemia that has relapsed or has become resistant (or refractory) to standard therapies.     This research study is evaluating a drug called KPT-330. Laboratory and other studies suggest     that the study drug, KPT-330, may prevent leukemia cells from growing and may lead to the     destruction of leukemia cells. It is thought that KPT-330 activates cellular processes that     increase the death of leukemia cells. The main goal of this study is to evaluate the side     effects of KPT-330 when it is administered to children and adolescents with relapsed or     refractory leukemia.   "
91285|NCT02091232|"     This research study is for patients who are going to receive a kidney transplant from a     living donor. After kidney transplantation, it is necessary for transplant recipients to take     immunosuppressive drugs. These drugs work by preventing the body's immune cells from     attacking and rejecting the new kidney. Taking these drugs long-term may also cause harm to     the transplanted kidney. Therefore, the transplant community is very interested in finding     ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney     rejection. One method to do so is known as induction of tolerance, which is when the person     who receives a transplant has treatment to make their immune cells tolerant to the donor     cells.      In this study, we will try to induce tolerance by mixing recipient cells and their donor's     cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that     attaches to immune system cells, interferes with the immune response and results in tolerance     induction.      After we mix the recipient cells with the donor's cells, we will sort out one particular kind     of immune cell, called a regulatory T cell, and inject them back into the recipient.     Regulatory T cells are the cells that are affected by induction to reduce rejection of     donated organs. This method for inducing tolerance has been used in bone marrow     transplantation, but this is the first time it is being done in kidney transplantation.      This study is being conducted as part of a unique collaboration of US and EU centers called     The ONE Study. The ONE Study centers have agreed to work together using common protocols and     procedures but with each testing their own regulatory population for safety and the ability     to promote kidney survival. Sharing data among the participating sites will permit a deeper     understanding of how and why some treatments might succeed while others work less well.   "
91294|NCT02091115|"     Constipation is a disorder which can be associated with various pathologies or could also be     an effect of the consumption of drugs, improper diet and life style. Is increasingly common     the utilization of probiotics in foods. Probiotics are defined as live microorganisms     administered in adequate amounts confer a health benefit to the host, the most widely used     for milk-based drinks are lactic bacteria Lactobacillus and Bifidobacterium. The objective of     the present study is to assess the effectiveness of the consumption of dairy beverage     enriched with probiotic for the treatment of the symptoms of constipation.   "
91295|NCT02091102|"     The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles     using a 755nm Alexandrite Laser.   "
91296|NCT02091089|"     The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles     using the picosecond 755nm Alexandrite laser.   "
92601|NCT02074020|"     The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a     composite responder index in subjects who, despite corticosteroid use, continue to have     autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by     SELENA SLEDAI score ≥10.   "
91286|NCT02091219|"     The purpose of this study is to compare the effects of two different forms of vitamin D     supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the     blood, and on markers of skeletal and immune health. This study is designed as a pilot study.     A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12     Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a     screening visit during which a medical history will be taken, a physical exam performed, a     dietary questionnaire administered, and blood collected. The purpose of the screening visit     is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are     candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to     receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After     initiating supplementation, study patients will return for follow-up visits at weeks 4, 8,     and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as     well as markers of skeletal and immune function. Participation in this study will therefore     involve a total of 5 visits (1 screening visit, 1 randomization visit during which     participants will receive their study supplements, 3 follow-up visits). After all data is     collected, changes in vitamin D levels in the blood following supplementation with either     vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance     and immune function. Knowledge gained from this study may have a significant impact on how     vitamin D status is defined, and how vitamin D repletion is administered.   "
91287|NCT02091206|"     To evaluate the safety and pharmacokinetics of multiple doses of GWP42003-P compared with     placebo in children with Dravet syndrome.   "
91288|NCT02091193|"     The purpose of this study is to evaluate the effects of krill oil supplementation in patients     with Type 2 diabetes mellitus on heart health and laboratory diabetic measurements.      Patients who enroll in this study will be asked to visit the Western Connecticut Health     Network Biomedical Research Institute on 3 separate occasions: for baseline testing, after 4     weeks of supplementing with krill oil, and after 4 weeks of supplementing with a placebo.     Patients will be randomized into one of two groups to determine the order in which they     receive the supplement and placebo. Every patient will receive both the krill oil and the     placebo, but both the coordinator and the patient are blinded to which is which. At each     visit, participants will undergo a non-invasive test which measures the function of the inner     lining of blood vessels and they will also have blood drawn. Fasting is required before each     appointment. The blood drawn is used to measure their Hemoglobin A1C, Glucose, HDL, LDL,     total cholesterol, C-peptide and total antioxidant capacity.      Risks to taking krill oil supplements are likely to include bad breath, heartburn, fishy     taste, upset stomach, nausea, loose stools, gas, and bloating. Risks of EndoPAT testing are     not permanent and may include pain, numbness, tingling, redness, and bruising at the site of     the blood pressure cuff. Risks that are associated with drawing blood may include redness,     swelling, pain or discomfort, bruising at the site of the needle stick, or in very rare     cases, infection at the needle site. To minimize these risks, trained technologists and     phlebotomists will be used for all procedures.      This is not a treatment option; while involved in this study all participants will continue     their regular treatment for Type 2 diabetes mellitus (as well as any other applicable     conditions).   "
91289|NCT02091180|"     Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for     laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease     in cerebral perfusion pressure.   "
91290|NCT02091167|"     In this study, eligible crack-cocaine addicted inpatients recruited from a specialized clinic     for addiction treatment, filling inclusion criteria and not showing any exclusion criteria,     will be randomized to receive the repetitive (5 sessions, every other day) bilateral     dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes,     3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine will be     examined before (baseline), during and after the end of the tDCS treatment. Other clinical     outcomes, and also visual P3 event-related potential and neuroimagings exams will be also     performed before and after treatment.      Based in our previous data, our hypothesis is that repetitive bilateral tDCS over dlPFC will     favorably change clinical, cognitive and brain function in crack-cocaine addiction and these     will be long-lasting effects.   "
91291|NCT02091154|"     The investigators hypothesize that the new United States Department of Agriculture (USDA)     regulations for lunches served as part of the National School Lunch Program will decrease the     percentage of enrolled students purchasing lunch, increase the percentage of children taking     fruit and vegetables, decrease the percentage of fruit and vegetable servings being thrown     away, and increase the total number of fruit and vegetable servings eaten.      The investigators also hypothesize that when the regulations are in force, simple behavioral     interventions can counteract the potentially negative impact on lunch sales and consumption.     In other words, implementing the regulations and behavioral interventions together, the     percentage of enrolled students taking a school lunch will increase at least back to baseline     levels, the percentage of children taking fruits and vegetables will increase, the percentage     of fruit and vegetable servings wasted will decrease, and the total number of fruit and     vegetable servings eaten will increase.   "
91292|NCT02091141|"     This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of     six treatment regimens in participants with advanced solid tumors for whom therapies that     will convey clinical benefit are not available and/or are not suitable options per the     treating physician's judgment.   "
91293|NCT02091128|"     With this study, in which the incidence of pregnancy in classic galactosemia patients is     studied, we aim to provide new insights to improve counselling. Our hypothesis is that the     chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has     been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be     evaluated through semi standardized interview in women with classic galactosemia aged 18     years or older. During the interview, questions will be asked regarding fertility and     pregnancy.   "
91383|NCT02089958|"     Incisional hernias are one of the most frequent complications in abdominal surgery.     Laparoscopic repair is widely used but even not standardized. Existing data from different     study designs show no representative data resulting in a lack of comparability and evidence.     Therefore the standardization of operative techique has been proposed by the LIPOM-study     group and will be assessed in a prospective manner.   "
91297|NCT02091076|"     A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be     closed by primary and secondary wound closure. Accelerated re-epithelialization rate and     minimizing pain and infection are main goals of donor care. Traditionally dressings are     inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have     developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin     and silk sericin were selected to produce wound dressing in this study. The objective of this     study is to compare wound dressing containing silk fibroin with bioactive coating layer with     standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to healing     time, patients' pain intensity, skin's transepidermal water loss after healing and evidence     of infection in the treatment of split-thickness skin graft donor sites. The study design is     a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years and undergo     STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital will be     recruited in the study. The exclusion criteria are donor sites other than thigh area or     located at high risk of infection. Patients who are immunocompromised or diabetes mellitus or     psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known allergic to SS     or SF or paraffin or chlorhexidine acetate are also excluded. All subjects sign the informed     consents after discussion the protocol, benefits and risks. The donor site will be divided     into two equal halves, each site will be randomized to receive the tested material or the     medicated paraffin gauze dressing. The donor site wounds will be observed daily. The     dressings will not be changed, except when they are fully soaked with exudates and easily     fell off or any sign of infection. Healing time will be recorded when the dressing separate     completely from the donor site, no exudates and no pain when the donor site is exposed to     air. The patient's pain level will be evaluated with the visual analogue scale and the donor     site wounds will be observed daily for signs of infection. On the day of the wound is     recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the skin barrier     function (TEWL) of each site will be measured using a Tewameter. Blood sample will be     collected from patients pre- and postoperatively (within day 3) for hepatic and renal     function analysis.   "
91298|NCT02091063|"     This will be an open-label, single agent, multi-institutional phase Ib/II study of ACY-1215     for the treatment of patients with relapsed or refractory lymphoid malignancies. The target     population will include patients with histologically confirmed relapsed or refractory     non-Hodgkin's lymphoma or Hodgkin's lymphoma, with an expansion cohort of patients with     mantle cell lymphoma.      The phase Ib will be conducted to determine the safety and tolerability of two dosing     schedules of ACY-1215 monotherapy in patients with lymphoid malignancies. Patients will be     accrued simultaneously to two dose cohorts (Arm A and Arm B) of ACY-1215. Selection into each     cohort will occur by alternation. All patients will take the prescribed dose of ACY-1215     orally for 28 consecutive days. Patients enrolled into Arm A will take ACY-1215 160 mg daily     (QD), whereas patients enrolled into Arm B will take ACY-1215 160 mg twice daily (BID).     ACY-1215 will be supplied as a liquid for oral administration (PO). Each dose will be     administered at least 1 hour after ingestion of food followed by at least 4 ounces of water.     Patients will be instructed not to ingest food or other oral medication for at least 2 hours     after each ACY-1215 dose. Frequency in phase II will be determined based on Phase Ib results.   "
91299|NCT02091050|"     Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy     treatment and assess whether tridimensional dosimetry relates more faithfully with the     occurrence of adverse effects.   "
93833|NCT02057900|"     The purpose of the study is to assess the feasibility and safety of a transplantation of     cardiac-committed progenitor cells derived from human embryonic stem cells in patients with     severe heart failure.   "
91302|NCT02091011|"     The study is to determine the rate and cause of device replacements at 5 years     post-implantation. It will assess the battery and device longevity of the Implantable     Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator     (CRT-D) devices. It will also validate the device survival information given in Boston     Scientific's Product Performance Report by comparing the pulse generator (PG) survival     probability in the study to that presented in the Product Performance Reports (PPR)   "
91303|NCT02090998|"     This study will compare a local anesthetic technique that has been used to treat subjects     suffering from transformed migraines (chronic migraines) versus medical management with     traditional antidepressant Amitriptyline / Elavil.      Subjects will be randomized into one of two treatment groups to compare the safety and     efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block     with 5% lidocaine gel into the nasopharynx or medical management with traditional     antidepressants, Elavil, to produce a reduction in the frequency and severity of the     headache.      We propose that there will be a difference in the outcomes when comparing the two methods of     treating transformed migraines and that one research arm will result in more patient     satisfaction and greater efficacy in the treatment of subjects   "
91304|NCT02090985|"     In this study a technique called 'lipomodelling' is being studied to find out if it is     beneficial around the stoma site in patients who have difficulty with securing their stoma     bags which may lead to leakage and frequent soiling which we believe reduces quality of life.      Patients with colostomy (stoma formed by bringing large bowel to the surface of the abdomen),     ileostomy (small bowel) or a urostomy (urinary tract) will be recruited into this study.      Lipomodelling is a technique that is commonly used elsewhere in the body but to our knowledge     has not been used for this purpose. This study is a pilot study that may lead to further     research in this area.      Lipomodelling means taking some of your own fat that lies just beneath the surface of the     skin and transferring it to another part of your body. The fat is removed by suction     (liposuction), normally from your thighs or abdomen. In order to use the most important part     of the fat, it is then put into a machine called a centrifuge. This spins the fat so that it     splits up into three different sections. The most important section is then separated and     injected in very small quantities into the required areas around your stoma. It is thought to     have cells that encourage rejuvenation as well as helping to fill the area injected.      Peri-stomal means the area around the stoma itself, this includes skin and underlying tissue,     which will be fat and scar tissue. After any operation there will be scarring that takes some     time to fully develop. Usually after a year the scar tissue will be fully formed. The scar     tissue may cause the skin around the stoma to be irregular. This is described as contouring     of the skin.      The aim of this study is to see if lipomodelling can improve your quality of life by reducing     the frequency of changing your stoma bag, reduce leakage and the need for extra-stomal     appliances to try and help the stoma bag fit to your body securely.   "
91305|NCT02090972|"     In this study, the risk of opioid medications on fractures in older adults is investigated.     Patients from the surgical department with fractures and control patients from the internal     department of the same hospital are inquired with a standardized questionaire about     demographic and clinical risk factors for fractures. Osteoporotic fracture risk is assessed     using quantitative ultrasound. An impact of recent opioid medications on fractures is     hypothesised.   "
91306|NCT02090959|"     The main goal of this Phase 3 extension study is to obtain long term safety of ataluren in     boys with nonsense mutation dystrophinopathy as determined by adverse events and laboratory     abnormalities. The study will also assess changes in physical function, pulmonary function     and other important clinical and laboratory measures.   "
91416|NCT02089516|"     The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod     in measuring movement / physical activity in frail elderly.   "
91307|NCT02090946|"     The experiences of learning from paediatric physiotherapists were explored through     unstructured interviews applying Colazzi's method to interpret the data. In this hermeneutic     phenomenological study, six parents responsible for a physiotherapy home programme for their     child were selected through convenience sampling. The purpose of this study was to obtain     rich and valid information that could be analysed. The phenomenon of their learning     experiences was formed and explored, its implications discussed and inferences made in light     of current physiotherapy service delivery.   "
91308|NCT02090933|"     This clinical trial studies celecoxib in decreasing the damaging effects of sunburn in     healthy volunteers. Celecoxib may reduce skin damage by blocking enzymes associated with     sunburn in healthy volunteers.   "
91309|NCT02090920|"     This study looks at the effects of a mother's genes and other characteristics (mother's age,     baby's age, race, and other diseases) on the ability of nifedipine to end contractions and     prevent an early delivery. This information will be used to decide what amount of nifedipine     women need to best treat preterm contractions.   "
91310|NCT02090907|"     Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a     controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to     estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the     effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by     lab results will be randomized to two groups of treatment with one daily dose of 100 mg     Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated     before and after the study.   "
91311|NCT02090894|"     The objective of this study is to examine the ability of dermal rejuvenation therapies to     protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers     (including basal cell carcinoma and squamous cell carcinoma) are the most common types of     malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes     specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are     allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much     greater in elderly over younger individuals. The objective of the present study is to build     upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a     localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects.     Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG     laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets     the microvasculature and stimulates collagen production while protecting the epidermis.     Generally, Laser Genesis is used clinically to improve irregularities in the contour,     texture, and color of the skin. Laser Genesis is also used to help treat photoaging by     increasing collagen formation, suggesting that it stimulates fibroblast activity and thus     possibly increases levels of protective IGF-1.   "
91320|NCT02090777|"     The study will be conducted to examine the feasibility of using a Health Coach for improving     the ophthalmic care of glaucoma patients. Patients taking glaucoma medications will have a     coaching intervention and adherence to glaucoma drops will be monitored using a     dose-recording device. The dosing data will be analyzed to examine the effect on adherence     and qualitative interviews at the conclusion of the study will be used to examine which     elements of the coaching experience were most helpful in the glaucoma patient population.   "
91312|NCT02090881|"     Sickle cell disease (SCD) affects haemoglobin - the molecule in blood cells which carries     oxygen. It causes red blood cells to become abnormal crescent (or sickle)- shaped. Sickled     red blood cells cannot travel through small blood vessels as easily as normal red blood cells     which can lead to blockages. This means that oxygen may be prevented from getting to where it     is needed. Individuals with sickle cell disease also suffer form abnormality in the lining of     their blood vessels, which contributes to the damage.      Damage and blockage can occur in the blood vessels in the brain and means that children with     sickle cell disease have a significant risk of suffering from strokes. Research has shown     that transcranial Doppler ultrasonography can be used in this setting to identify children at     most risk of getting strokes.      Ultrasound is therefore used in children with sickle cell disease to measure the blood flow     in the vessels in the brain. This research has formed the basis of the National Health     Service (NHS) Standard of Care for Sickle Cell Disease in the United Kingdom (UK) which uses     transcranial Doppler ultrasonography at once a year to screen children with sickle cell     disease aged 2 to 16.      Ultrasound is used because it is portable, does not uses ionising radiation such as x-rays,     is non-invasive and gives good results. However, the results are dependent on the operator.     This means that the screening service is provided by centres of excellence with experienced     scanning staff visiting clinics in smaller hospitals with portable machines. There is a lack     of research comparing the use of portable machines to laboratory-based machines. This is     important because screening can identify children at high risk of stroke and may be used by     clinical staff to make a decision about the care of the child.   "
91323|NCT02090738|"     Helicobacter pylori infection is associated with several gastric diseases, including     gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO     classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two     antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging     antibiotic resistance to metronidazole or clarithromycin, however, has made successful     treatment of infection progressively more difficult, with the success rate of standard triple     therapy now at 70%, well below the 80% required for treatment of infectious diseases.     Therefore, new treatment regimen is required for successful H. pylori eradication.      On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H.     pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated     that mutation of carbonic anhydrase affected survival of H. pylori. The investigators     therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with     standard H. pylori eradication regimen would increase the eradication rate. Here, the     investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for     H. pylori eradication.   "
91324|NCT02090725|"     The main purpose for this study is to provide access to 3,4 DAP, a drug which has     demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic     Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The     disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and     autonomic dysfunction.   "
91313|NCT02090868|"     This study aims to explore how the introduction of an oral intake screening tool can benefit     patients requiring noninvasive ventilation. The Quality Care Commission has identified     nutritional problems in hospital and there is much literature on the importance of nutrition     when critically ill. Literature is short however concerning the specialized population of     those requiring noninvasive ventilation and they are a high risk group of suffering from     malnutrition.      This study will potentially benefit patients by improving their nutritional care through     guided assessment and nurse training.      The study will use mixed methodology, a prospective cohort study and qualitative interviews.     The prospective cohort study will collect data from patients prior to the tool introduction,     the control group, and post the tool introduction, the exposure group. This will enable     comparisons to be made between the exposure and the control groups.      Nurses will be interviewed in semi structured focus groups prior to tool introduction and     post to identify themes and sub themes to give a deeper understanding of nutrition in     hospital and to examine the use of the tool in practice.      Patients will be eligible if they are over 18 and requiring noninvasive ventilation and     nurses will be eligible if they work on the high dependency unit. Patients will be visited     daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The     other daily visits will involve collecting data, which is recorded as part of routine care.      Nurses will undergo 2 focus group interviews and a teaching session. The study will take     place at St Mary's hospital funded by Imperial College London. The study will be split into     two periods with a two week gap in between. Each period will last until 22 patient     participants have been recruited.   "
91314|NCT02090855|"     Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged     in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain     images previously obtained in Study GE-067-007 will be interpreted visually in randomized by     5 independent readers who are blinded to all other subject information, and the images will     be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative     for abnormal neuritic plaque density). The numbers of images in each category will be used to     calculate sensitivity and specificity.   "
91315|NCT02090842|"     Epidemiological studies demonstrated an inverse associations between cardiovascular events     and milk and dairy product consumption. Evidence from human intervention studies suggests     that both whey and casein may be effective in blood pressure-lowering, however there is     limited data on the impact of milk proteins on vascular function. This research aims to     compare the potential acute and chronic impacts of the two main milk proteins (whey and     casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects     of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory     status will also be investigated in 'at-risk' individuals.      This research includes both an acute and chronic intervention study which have been     independently powered on the appropriate outcome measures. This has generated different     sample size requirements for the two studies (Actual participants on the acute study: n=27,     and on the chronic study: n=38).   "
91316|NCT02090829|"     : The objective of this study is to determine the tolerability and therapeutic potential of     oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a     computer game intervention that is designed to enhance face perception skills. We designate     two measures as our primary outcomes, based on prior published work with these interventions,     and we propose a sample based on power analyses from these prior results. A second objective     of this study is to learn about the breadth of possible positive effects that this     combination therapy might have for children with ASD. To this end, we include a host of other     exploratory measures that assess aspects of social motivation and attention, social     perception, and social cognition. Thus, a second objective is to conduct a signal finding     study - to gather outcome data on a range of dependent variables that theoretically should be     related to oxytocin's effects on social processes, but for which there are no prior data. The     signal finding aspect of this study will provide the preliminary data needed to design a more     targeted follow up study.   "
91317|NCT02090816|"     The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is     effective in the surgical treatment of simultaneous liver and right lung metastases from     colorectal cancer   "
91318|NCT02090803|"     The purpose of this study is to assess the human herpes virus reactivation 6 post autologous     stem cells in 196 patients. The aim of our study was to describe the incidence of     reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic role     in this target population.   "
91319|NCT02090790|"     the aim of this study was to investigate compare the effect of peroperative intravenous     single dose dexamethasone and the addition of dexamethasone to femoral nerve block on     postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty     patients   "
91322|NCT02090751|"     Age Related Macular Disease (AMD) is easily the leading cause of blindness in older people in     developed countries. It affects between 30 and 50 million individuals worldwide, with around     30% of the over 65's showing early signs of the disease. Severe AMD has a devastating impact     on the quality of life; it causes extensive visual impairment, making reading difficult and     driving impossible. Patients lose their independence and become a major burden on public     health systems.      Present treatment options are limited. Many new therapies are under development and all will     need evaluation using a test with high specificity and sensitivity for early AMD. The present     application will develop such an instrument. The prototype was funded by a previous i4i FS     (feasibility study ll-FS-0110-14036). The new device measures sensitivity to a dim flickering     light using the same principle as an established european conformity marked (CE marked)     instrument. The original method involved lights of different wavelengths and higher     intensities.      The instrument in this study assesses night vision, which is selectively damaged in early     stage AMD. In low lighting, the investigators vision depends on specialized rod     photoreceptors. Cone photoreceptors, which provide daytime vision, remain normal in the early     stages of the disease. By the time patients complain of reduced (cone-based) visual acuity,     they will have had the disease for many years and lost many thousands of photoreceptors.   "
91366|NCT02090179|"     The purpose of the study is to characterize structural abnormalities in the brain and the     integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS     IIIB).   "
91325|NCT02090712|"     At the periphery of the city of São Paulo, in-hospital mortality in acute myocardial     infarction is estimated to range between 15% and 20% due to difficulties inherent to delayed     answer at a large metropolis. As a city with more than 11 million inhabitants, the     distribution of emergency services and public hospitals is also heterogeneous, with scarcity     in peripheral zones. That heterogeneity of resources also involves the quality of the medical     care provided. The possibility of a standard care with fast transfer after thrombolysis and a     tertiary backing system for ECG interpretation, catheterization and advanced support could     improve this setting.      In a project initiated in 2010, the São Paulo Municipal Health Secretariat, the Federal     University of Sao Paulo/Paulista School of Medicine, the Emergency Mobile Health Care Service     arranged a planed system of thrombolysis at peripheral hospitals or at the ambulances with     immediate transfer to a unique tertiary center for early angiography and angioplasty of the     culprit artery. The protocol uses recommendations of Brazilian and international guidelines,     and is the same adopted for the management of ST elevation myocardial infarction at Paulista     School of Medicine regarding the indications for thrombolytic agents, primary and rescue     percutaneous transluminal coronary angioplasty (PTCA), and pharmacoinvasive therapy.      The hypothesis of this study is that a network to provide the best care for patients with ST     elevation myocardial infarction will reduce mortality rates.      The main purpose of this registry is to provide demographics, metrics and results of this     experience, maintaining complete records of clinical, laboratory and coronary angiography     data of all patients allowing short-term outcome analysis of various variables in a large     population. Additionally, follow-up outcomes will be provide in a sub-group of patients     keeping their health care at the University or able to be tracked.      All clinical endpoints of main interest will be assessed as single or composite endpoints for     evaluation at different time intervals.   "
91326|NCT02090699|"     Cardiac failure is the major cause of death in patients with thalassemia and chronic blood     transfusion-related iron overload. The treatment of thalassemia has been revolutionized over     the past decade with the implementation of cardiac MRI based assessment of iron overload.     This has enabled detection of cardiac iron overload prior to symptomatic heart failure and     now allows for timely therapy which has resulted in a substantial decrease in mortality.     However, currently implemented MR imaging techniques assess for iron content only and not for     iron related diffuse fibrosis which play a role in iron related heart failure.     Histopathologic studies indicate that patients with iron overload have diffuse interstitial     fibrosis. Quantitative MR techniques have shown that patients with various cardiomyopathies     demonstrate diffuse myocardial fibrosis and that these changes correlate with changes in     cardiac function. The investigators propose that quantitative cardiac MRI for assessment of     diffuse myocardial fibrosis can further improve our ability to detect early damage to the     myocardium and prevent morbidity and mortality from cardiac iron overload. Detection of     fibrosis in patients with thalassemia may allow for earlier identification of cardiomyopathy     when compared to other techniques in clinical use including T2* analysis. Identification of     fibrosis could affect patient management as it would allow for tailoring of iron chelation     therapy and may lead to better understanding of the disease processes contributing to heart     failure and arrhythmia in these patients.   "
91327|NCT02090686|"     The purpose of this study is to determine whether pulsatile cupping with a cupping device is     effective in the treatment of patients with chronic low back pain compared to no cupping or     to minimal cupping.   "
91328|NCT02090673|"     The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the     clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the     safety and effectiveness information about Exenatide in general practice.   "
91329|NCT02090660|"     This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence     localization technique with a Laser fluorescence thoracoscope system.      The primary objective of this study is to prove the validity and safety of our novel     fluorescent localization method with utilized ICG and novel near infra-red fluorescence     videoscope system.   "
93834|NCT02057887|"     The purpose of this study is to evaluate the safety and tolerability of multiple ascending     doses of HM10660A in subjects with chronic hepatitis C(HCV).   "
91330|NCT02090647|"     The objective of the study was to assess the aesthetic outcome of different abutments     materials and shapes on dental implants .      A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue     , radiographic evaluations and clinical photographs, was used to obtain a measure of the     aesthetic of implant-prosthesis rehabilitations.   "
91331|NCT02090634|"     Adherence to combination antiretroviral therapy (ART) is critical for successful HIV viral     suppression. Nonadherence to ART poses several potentially serious health consequences,     including higher viral loads, faster progression to AIDS, and a heightened risk of viral     mutations, treatment resistance and HIV transmission.      The prevalence of serious mental illness (SMI) conditions, including bipolar disorder (BD),     is elevated among HIV-infected populations and is associated with poor ART adherence.     HIV-infected individuals with co-occurring BD (HIV+/BD+), when compared to demographically     similar HIV+/BD- persons, demonstrated poorer ART and psychotropic medication adherence and     were twice as likely to be non adherent to their ART regimen using a ≥ 90% cutoff score.     HIV+/BD+ individuals are particularly at-risk for medication non adherence, and there is a     critical need to develop interventions to improve adherence in this population.      Poor psychotropic medication adherence is also common among people with SMI - it has been     estimated that 40% of those with BD do not take their mood stabilizer as prescribed. Among     persons with BD, nonadherence to psychotropic medications can lead to greater risk for manic     and depressive episodes, decreased quality of life, suicide attempts, and hospitalization.      The utilization of mobile health (i.e., mHealth) technologies to improve everyday functioning     is growing. mHealth interventions capitalize on technology already incorporated into most     people's daily lives (e.g., cell phones) to assist people with behavior modification and     disease self-management. Text messaging, in particular, may support daily ART adherence by     delivering reminders at precise times to match an individuals' dosing schedule. The initial     evidence for using text messaging to improve ART medication adherence has been compelling.     Researchers and clinicians have also started employing technology-based approaches to improve     treatment for individuals with BD.      Taken together, a distinct need for RCTs utilizing text messaging to improve medication     adherence within an at-risk HIV population is warranted. Individualized Texting for Adherence     Building (iTAB) is one such intervention.      The investigators propose an intervention development study designed to address these     potential mechanisms of nonadherence with the following Specific Aims: 1) To further develop     and refine a personalized, automated, real-time, mobile phone, text messaging intervention     (iTAB) designed to improve adherence to ART and psychotropic medications among HIV+/BD+     persons; 2) To evaluate the acceptability and effectiveness of a brief psychoeducation plus     text messaging intervention (iTAB) as compared to psychoeducation alone (CTRL) for the     improvement of objectively measured medication adherence among HIV+/BD+ persons; and 3) To     examine predictors of within-person trajectories of nonadherence using the longitudinal data     collected over the study. In order to realize these aims, the investigators will leverage the     infrastructure of two unique UCSD resources increasing likelihood of study success, impact,     and innovation: 1) the HIV Neurobehavioral Research Program (HNRP), which encompasses     multiple NIH-funded studies that focus on the effects of HIV infection, and 2) the California     Institute for Telecommunications and Information Technology (Calit2), which conducts research     on state-of-the-art wireless means of health promotion. Initially, the investigators will     refine the iTAB intervention to ensure that it is user-centered and tailored to the needs of     HIV+/BD+ persons via focus groups and rapid prototyping. Once refined, the proposed iTAB     intervention will use text messages that are automated, scalable, personalized, interactive,     flexible, and motivating. The investigators will assess the acceptability and effectiveness     of iTAB in improving objectively measured adherence (i.e., MEMS caps) over a 4-week period     via a pilot RCT with 25 HIV+/BD+ assigned to the iTAB intervention and 25 HIV+/BD+ assigned     to a psychoeducational control. Predictors of nonadherence including neuropsychological     impairment, and mood will be examined to determine whether iTAB is better able to compensate     for these factors associated with nonadherence as compared to CTRL. Further refinement to the     iTAB intervention will be made in order to pursue a large-scale R01 using the investigators     tailored intervention.   "
91332|NCT02090621|"     The purpose of this study is to determine the safety of photopheresis for prophylaxis of     allograft rejection in patients who are being withdrawal immunosuppression after liver     transplantation.   "
91333|NCT02090608|"     Proteinuria is the predominant risk factor for renal disease progression in Fabry disease     (FD). When urine protein excretion is controlled to <0.50 g/24 hr, the rate loss of     glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme     replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended     that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy.     Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of     intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is     to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria >0.50 g/24 hr     persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.   "
91334|NCT02090595|"     Children who have parents with bipolar disorder are at risk for developing anxiety disorders.   "
91335|NCT02090582|"     The purpose of this study is to test the effect of the gynecologic oncologists with     palliative care specialist collaboration (GO-PC) intervention on patient quality of life.   "
91336|NCT02090569|"     High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During     Brain Surgery (ULYS)   "
91337|NCT02090556|"     The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in     routine clinical practice, in rheumatoid arthritis patients, in each country involved in the     study. The purpose of the UK substudy is to explore whether integrating self-assessment into     routine care could maintain tight control (of inflammation/disease activity) and at     potentially lower cost resulting in improved health outcomes and cost-effectiveness.   "
91367|NCT02090166|"     Purpose: To evaluate the performance of Extracellular Monitoring of Metabolic Activity     Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung     cancer.      The study population will include a total of 950 participants, patients with lung cancer     before any treatment, and healthy and COPD patients as a control group.   "
91368|NCT02090153|"     The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin     (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent     gastric cancer.   "
91338|NCT02090543|"     According to recent guidelines, long-term anticoagulation is recommended for patients with     atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K     antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment     options for AF patients with additional risk factors for stroke. Currently there are only     limited information to what extend AF patients prefer one or the other treatment option based     on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown     which of the characteristics influences patient preference most and how this relates to a     neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate     their current treatment and if this leads to differences among treatment with VKAs and     rivaroxaban.   "
91339|NCT02090530|"     Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing   "
91340|NCT02090517|"     The aim of this study is to compare the efficacy of various treatment options for eliminating     nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias     with the following; no treatment (control site), alexandrite laser, pulsed dye laser,     combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.   "
91341|NCT02090504|"     Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome     (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a     treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized     double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam     in the treatment of alcohol withdrawal symptoms (AWS).   "
91342|NCT02090491|"     Autism Spectrum Disorder (ASD) is a collection of complex neurodevelopmental disorders     characterized by qualitative impairments in socialization, communication, and circumscribed     interests, including stereotypical behavior patterns and behavioral rigidity to changes in     routines (American Psychiatric Association, 1994). ASD is the fastest growing pervasive     developmental disorder of childhood, currently estimated to affect 1 in 88 school age     children (Baio, 2012). ASD typically manifests in infancy and persist throughout the     lifespan. There is no known cause or cure for ASD, yet structured behavioral interventions     and medications can enhance developmental outcomes. ASD has a profound impact on families and     often result in enormous emotional and financial costs. Recent estimates suggest that     societal costs in the US to care for all individuals diagnosed each year over their lifetime     approaches $35 billion (Ganz, 2007).      Janssen Research & Development is building a comprehensive digital platform (MENTIS) to     optimize and enhance development of novel medicines and track outcomes in individuals with     ASD. The MENTIS platform contains several core components, including: (1) An electronic     personal healthcare record, designed specifically for individuals with ASD and their     caregivers (parents, teachers, healthcare providers); (2) Integrated physiological and     physical activity biosensors designed to objectively assess outcomes important in ASD, and;     (3) A de-identified research data warehouse with analytic tools to better measure outcomes,     assist with sub-population identification, and identify algorithms for diagnosis and     treatment response detection.      The MENTIS platform is currently being designed, developed, and prepared for testing. During     this process it is highly desirable to conduct feasibility and usability research with a     sample of the target population to identify important system components and features,     optimize design, and reduce redundancy in software development and research time. The rapid     pilot study described herein is proposed to gather incipient feedback on select MENTIS system     components and features from stakeholders who support individuals with ASD in a clinical     setting. This pilot research will help evaluate both how well current MENTIS system features     work in an applied setting and inform future directions for MENTIS platform development.   "
91343|NCT02090478|"     The purpose of the study is to determine how reducing the amount of simple sugars in the diet     affects sweet taste perception. Healthy adult subjects will be assigned to either follow     their usual diet, or to replace sugar calories with fats or starch.      The investigators hypothesize that eating less sugar will:        1. cause foods and drinks with a given amount of sugar to taste sweeter        2. cause people to prefer lower levels of sugar in foods and drinks   "
91344|NCT02090465|"     Assessment of treatment success and quality of life in patients with actinic keratoses under     therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.   "
91345|NCT02090452|"     The purpose of this study is to examine if real time transmission of vital signs, ECG and     chat communication between the prehospital ambulances and the emergency department has an     effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to     treatment and time to diagnostics   "
93849|NCT02057692|"     The study is a randomized, double-blind, placebo-controlled study in children with Alagille     Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on     pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with     ALGS.   "
91346|NCT02090439|"     In the diagnosis of renal colic gallstone , in addition to clinical and biological factors,     it is a key : medical imaging. Currently , the French recommendations require at least a     couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal     ultrasound . The abdominopelvic CT scan without injection of contrast is the examination of     choice.      Current recommendations in the management of gallstone colic simply based on the joint use of     analgesics , anti inflammatory drugs and control of water intake .      The mechanism of analgesic action of this treatment is a decrease in the pressure in the     cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage of     urine . )      The expulsive medical therapy remains under evaluation. The French Association of Urology     does not recommend at this time for lack of evidence deemed sufficient.      For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha     blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended     (grade 1A) . However, there are less formal studies of their effectiveness .      Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy for     pelvic stones 4 to 10mm .   "
91347|NCT02090426|"     This trial investigates the value created by the highly innovative Camden Coalition of     Healthcare Providers' Care Management Program: Link2Care. The program targets     super-utilizers of the health care system - specifically adults with 2 or more     hospitalizations in the last six months 2 or more chronic conditions, and 5 or more     outpatient medications - with intensive case management services. In particular, a team of     nurses, social workers, community health workers and health coaches, supported by real-time     data of healthcare utilization, perform home visits, accompany patients to doctor visits, and     help patients enroll in social-service programs. This approach aims to improve the     self-sufficiency of patients in navigating the healthcare and social-service systems and has     the potential to reduce healthcare costs and improve patient health.   "
91443|NCT02089165|"     The purpose of the study is to compare the acute bioavailability of two different krill oil     products called krill oil and krill meal in comparison to fish oil product.   "
91348|NCT02090413|"     The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin     (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF)     administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF     administration reduces the incidence and/or severity of flushing events in subjects with     relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF     in the clinical practice setting.      Secondary objectives of this study are: to evaluate the safety and tolerability of DMF     administered with and without enteric-coated ASA in the clinical practice setting; to     evaluate the impact of DMF administration on quality of life as measured by the Short Form 36     (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.   "
91349|NCT02090400|"     The aim of this study is see the changes in bone mineral density after discontinuation or     stop the use of bisphosphonates and make the switch to bazedoxifene).   "
91350|NCT02090387|"     The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the     lean body mass (LBM) loss that occurs after bed rest.   "
91351|NCT02090374|"     The investigators propose the development of a range of nasal spray challenge models to study     the way the nose can respond to different types of nasal challenge that elicit different     forms of inflammation.      The investigators will carry out nasal challenge with bacterial and viral components and     allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli of     the immune system, causing various types of inflammation. Samples will be taken by blotting     the nostril surface and by scraping off tiny surface samples.      The nose will be sprayed with a substance that is a single part of a bacteria or virus, or     with an allergen. The material delivered by nasal spray is of high purity and is sterile,     containing no live bacteria or viruses. The nasal spray substance contains molecular patterns     that are recognised as foreign by the immune system, and at the right dose should stimulate     the immune system, causing mild nasal inflammation. The study employs noninvasive methods of     sampling using absorptive strips. These strips look and feel like tissue paper, and are     applied to each nostril for a period of 1 min. A few pinhead-sized tissue samples are taken     from inside the nose, using a small disposable sterile plastic probe that has a tiny scoop on     its end. In the nasal lining fluid and tissue samples, measurement will taken of a range of     molecules and cells that protect against infections and help the immune response.      By spraying the nose with a challenge agent in this manner, the nasal immune response can be     assessed, which can help us better understand how the human immune system cells and molecules     respond to bacteria and viruses. In the future, this may allow the testing of new drugs and     vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge.   "
91435|NCT02089269|"     The registry aims to collect and analyse information on the antineoplastic treatment of     metastatic or locally advanced pancreatic cancer in daily routine practice in Germany. The     registry will follow up patients for two years. It will identify common sequences of     treatments used as well as changes in the treatment of the disease. Health-related quality of     life will be analysed during the course of the treatment (PanLife). Based on the available     data a prognostic score will be developed.   "
91353|NCT02090348|"     The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken     over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured     by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in     participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of     this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue     Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess     the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work     Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]),     health-related quality of life (Short Form Health Survey [SF-12]), depression (Beck     Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS])     at 6 and 12 months in participants receiving DMF; To examine whether an association exists     between fatigue and baseline demographics (e.g., age and sex) and disease characteristics     (e.g., disease duration, baseline disease activity, treatment history, expanded disability     status scale [EDSS] score, and PROs); To assess any changes in fatigue-related medication     use.   "
91354|NCT02090335|"     The goal of this project, which has not changed, is to improve the health and fitness of     persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles.     Participants are randomly assigned to the In SHAPE program or Health Club Membership and     Education only.      The three specific aims of this study are to:        1. To compare the treatment groups with respect to improvement in physical fitness          outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and          (b) indicators of physical fitness.        2. To compare the treatment groups with respect to improvements in mental health outcomes,          including negative symptoms, depression, and self-efficacy.        3. To explore differences in the treatment groups with respect to psychosocial functioning,          health status, and acute service use, and the effects of selected demographic, clinical,          and health behavior variables on primary outcomes.   "
91355|NCT02090322|"     The Retinopathy of Prematurity (ROP) is a Retina's pathology only of the premature baby, it's     characterized for proliferation of vascular tissue that grow in the limit between the     vascular retina and the avascular retina. The altered regulation of Vascular Endothelial Grow     Factor (VEGF) has been proposed as one of the principal factor in the pathogenesis of the     ROP.      The ROP is classified for: location (zones I,II,III), extension (hours 1 to 12) and for     stages (1,2,3,4a,4b,5) and features of the vessels (normal, pre-plus and plus).      With the diagnosis of ROP type 1(ROP zone I any stage with plus, zone I stage 3 without plus,     zone II stage 2 y 3 with plus) the treatment is begun and ROP type 2 is maintained in     observation.      The altered regulation of Vascular Endothelial Grow Factor (VEGF) has been proposed as one of     the principal factors in the pathogenesis of ROP.   "
91381|NCT02089984|"     Anxiety disorders are a major public health concern, having a profound impact on functioning,     causing significant disability, loss of productivity and suffering. Effective treatments     exist for these disorders, but few clinicians are trained in these methods. This project     attempts to remedy this shortcoming by using web-based tools to facilitate access to this     training, thus increasing the number of available therapists in order to help meet this unmet     need.   "
91356|NCT02090309|"     The investigators hypothesis is that low (or low relatively to the situation) cortisol levels     might be a causative factor of whiplash injury or post traumatic stress disorder following     road accidents. In this study the investigators enroll patients who sustained a road     accident. From all patients a blood sample will be withdrawn to measure cortisol     concentrations. Than, the patients will be divided into 2 groups: the study group will     receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid     used routinely for many years). The control group will receive a same volume of normal saline     which would be used as a placebo treatment. The investigators assume that patients with low     cortisol levels would tend to have a higher incidence of whiplash injuries and / or post     traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these     untoward sequelas of trauma.   "
91357|NCT02090296|"     Sickle cell anemia (SCA) patients experience organ damage that begins at an early age and     results in significant morbidity and early mortality. Although all SCA patients share the     same genetic mutation, the clinical complications are highly variable with some patients     experiencing frequent and severe complications, while others have few serious complications.     If SCA severity could be predicted early in life, those patients at greatest risk for     complications could receive treatment prior to the onset of organ damage. No general SCA     severity predictor or one that can be informative early in life exists. The investigators     preliminary research has identified the absolute reticulocyte count (ARC) as a potential     early predictive risk marker for SCA complications in pediatric patients. A higher ARC     between ages 2 and 6 months of age is associated with an increased risk of hospitalization in     the first 3 years of life; the mean ARC for the 36 patients who were hospitalized for SCA     complications was significantly higher than that of the remaining 23 in those who were not     hospitalized. Moreover, total hospitalizations were nearly three times higher by age 2 years     in those infants who had an ARC of > 200 than for those infants whose ARC was <200. The     proposed study will determine if ARC can be used as a risk-stratifier in asymptomatic infants     with SCA and ascertain its value in targeting hydroxyurea therapy to those infants at highest     risk of SCA sequelae.   "
91358|NCT02090283|"     The purpose of this study is to assess the continued safety of topical use of SD-101 cream     (6%) in subjects with Epidermolysis Bullosa      Funding-Source-FDA OOPD   "
91359|NCT02090270|"     The purpose of this study is to prospectively examine the relation between ischemic stroke     and hair cortisol concentration. The investigators hypothesize that patients with ischemic     stroke have higher levels of hair cortisol compared to controls.   "
91360|NCT02090257|"     The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and     test an intervention (i.e., a standardized, tailored transition program focused on enhancing     adherence) to improve outcomes for emerging adults who underwent heart transplantation as     children and transfer to adult care.   "
91361|NCT02090244|"     Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There     are so far only three published papers concerning humans. Postero-lateral fusions have shown     a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH     1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis     surgery.   "
91362|NCT02090231|"     Dysphagia is one of severe complications among stroke survivors. Dysphagia is usually     associated with high levels of morbidity, mortality, and financial cost. In recent years,     repetitive transcranial magnetic stimulation (rTMS) has shown promise to facilitate     poststroke dysphagia. However, most researches were preliminary studies in the past. The     present study aims to investigate the immediate and long-term efficacy of high frequency rTMS     on chronic dysphagic patients.   "
91364|NCT02090205|"     Background There is no unanimous opinion about a lung-protective strategy in cardiac surgery.     Small randomized clinical and animals trials suggest that ventilation during cardio-pulmonary     bypass (CPB) could be protective on the lungs. This evidence is based on surrogate end-points     and most of studies are limited to elective coronary surgery. According to the available     data, an optimal strategy of lung protection during CPB cannot be recommended. The purpose of     the CPBVENT study is to investigate the effectiveness of different ventilation strategies     during CPB on post-operative pulmonary complications.      Trial design The CPBVENT study will be a single-blind, multicenter, randomized controlled     trial. We are going to enroll 780 patients undergoing elective cardiac surgery with planned     use of CPB, aortic cross-clamping and two lung ventilation. Patients will be randomized into     three treatment groups: 1) no ventilation during CPB; 2) continuous positive airway pressure     (CPAP) with positive end-expiratory pressure (PEEP) of 5 cmH2O during CPB; 3) ventilation     with 5 acts/minute with tidal volume of 2-3 ml/Kg and a PEEP of 3-5 cmH2O during CPB. The     primary end-point will be the incidence of a PaO2/FiO2 ratio <200 until the time of discharge     from the ICU. The secondary end-points will be the incidence of post-operative pulmonary     complications and 30-days mortality. Patients will be followed-up to 12 months after the date     of randomization.      Summary The CPBVENT Trial will determine whether different ventilation strategies during CPB     will improve pulmonary outcome in patients undergoing cardiac surgery.   "
91365|NCT02090192|"     Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on     the lower extremity blood flow, mobility function, balance, muscle strength, bone density,     and general health status, and its feasibility as an intervention in frail elderly patients.      Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried     Frailty Criteria.      Interventions: All eligible subjects were randomly assigned to 4 groups:      (1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive     resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+     PRT group: Subjects received the whole-body vibration and progressive resistance training;     (4) Control group: Subjects received no intervention/training. The periods of intervention     are 12 weeks.      Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of     the common femoral artery), timed up and go test, 30-second chair stand test, five times sit     to stand test, lower extremities muscle strength, balance function, balance confidence, bone     density, and general health status was assessed at the beginning of the study, at instant, 12     weeks and 24 month after the intervention.      Study hypothesis: Whole-body vibration exercise is a safe and effective method that can     improve the lower extremity blood flow, mobility function, balance, muscle strength, bone     density, and general health status in the frail elderly.   "
91369|NCT02090140|"     The purpose of this study is to compare two biologic methods for the treatment of articular     cartilage defects in the knee. The first method, microfracture, is the standard of care and     is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage     loss. The second method is the application of adipose-derived stem cells (ADSCs) to the     defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more     specific progenitor cells to the site of injury, resulting in better regeneration and     integration of articular cartilage at the site of a defect as compared to the microfracture     method.   "
91370|NCT02090127|"     Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient   "
91371|NCT02090114|"     Single-arm, single site, open label study of the effects of parenteral testosterone followed     by enzalutamide or abiraterone or castration-only therapy in men with metastatic CRPC who     previously progressed on one of these forms of therapy. The study will enroll three cohorts     of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); men     with metastatic CRPC who have progressed on abiraterone acetate (Cohort B); and men with     metastatic CRPC who have progressed on first line castration-only therapy (Cohort C).   "
91372|NCT02090101|"     The metastatic colon cancer is a major public health problem despite advances in     chemotherapy; few new drugs are in development for the treatment of this pathology.      Many studies have shown that human colon cancer is a tumor that is recognized by the immune     system and the presence of lymphocytic infiltrates in the tumor bed is associated with a     better prognosis. Conversely, the effect of chemotherapy on the immune response is little     studied.      Recently the importance of myeloid suppressor cells (MDSC) in the development of colon cancer     and the effect of 5- fluorouracil on this cell population has been highlighted. An     accumulation of these cells in the blood and lymphoid organs during tumor progression is     observed. Moreover, it has been established that the death of MDSC induced by 5-fluorouracil     induces activation of caspase -1 and IL-1beta by these MDSC.      These events promote the polarization of CD4 T cells in intratumoral Th17 lymphocytes. The     IL- 17 produced by these cells exerts a pro-angiogenic effect in inducing proliferation of     endothelial cells expressing and thus limits the effect of 5- fluorouracil endoglin.      In humans, it has also been observed that chemotherapy using 5- fluorouracil and in     particular LV5FU2 association +/- bevacizumab induces rapid death of blood MDSC as well as     activation of caspase 1 in these cells. Thus, production of IL - 1 is detected in the serum     of patients after 24 hours of the administration of 5-fluorouracil.      Chronic inflammation and the production of interleukin- 1 can alter the effectiveness of anti     -tumor immune responses and facilitate angiogenesis. Many preclinical data suggest a role of     anti -tumor inhibition of IL- 1beta, but the effect of a combination of chemotherapy and an     inhibitor of IL - 1beta has not yet been tested in human.      Anakinra is a drug used in humans for many years to treat signs and symptoms of rheumatoid     arthritis. In combination with methotrexate, in patients whose response to methotrexate alone     is not satisfactory it had shown interesting results. The dose used clinically is 100 mg per     day which is the dose that is proposed to be tested in this study.      In this context it should be remembered that methotrexate is a chemotherapeutic agent from     the class of antimetabolites such as 5- fluorouracil.      RCP of this drug indicate that in studies originator toxicity was similar between the control     arm and anakinra arm with an increase in serious infections (1.8 % vs 0.7 %) and an increased     incidence of neutropenia (2.5 % neutropenia > grade = 1). The main toxicity observed is a     painful inflammatory reaction at the injection site in 70 % of patients The investigators     believe that this project could permit to validate in man preclinical observations showing an     anti-tumor potential for combination anakinra and 5 fluorouracil.   "
97835|NCT02005588|"     Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the     investigators are going to compare the efficacy and tolerability of two preparations of oral     iron in treatment of iron deficiency anemia with pregnancy.   "
91374|NCT02090075|"     Vitamin K-antagonists (VKA) such as warfarin are the most widely used blood thinners for     irregular heart beats like atrial fibrillation. Several lines of evidence indicate, however,     that these agents also cause calcification of vessels (hardening of the vessels). Vascular     calcification is one of the recently revealed side-effects of warfarin therapy. We will be     randomizing 66 patients to either take warfarin or a new blood thinner that works without     affecting vitamin k (apixaban). Patients will undergo blood testing and a CT angiogram     (non-invasive angiogram) at the beginning of the study, and then be followed for one year     with quarterly visits including blood tests and given either warfarin or vitamin K. After one     year, they will undergo another CT angiogram and examination and blood tests and the effect     of apixaban and warfarin are tested to look at plaque and changes over time. Patients will be     consented in a private room and the risks and benefits will be explained. The risks include     the CT angiogram and the possibility of either remaining on warfarin therapy for another year     (standard of care) or taking a medicine that doesn't require monitoring (apixaban) for one     year. The CT angiograms will require some contrast and some radiation dose, which will be     minimized as much as possible. A cardiologist will be present during each CT angiogram to     minimize risk and ensure patient safety.   "
91375|NCT02090062|"     Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens     become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study     aims to determine the difference in H. pylori infection rate of EGC patients before and after     ER , and discuss the causes leading to the difference, which can provide references for     improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.   "
91376|NCT02090049|"     The aim of this study is to evaluate the appetite rating of a soft bread with a high content     of fibre and protein (Puravita Breakfast®) as well as its capacity to modulate postprandial     levels of glucose, insulin and gastrointestinal hormones involved in appetite control and     insulin secretion in healthy adult volunteers.   "
91377|NCT02090036|"     The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine     added to standard artemether/lumefantrine treatment for the clearance of Plasmodium     falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above     regardless of their G6PD status.   "
91378|NCT02090023|"     The purpose of this study is to explore long-term prognosis and to identify the predictors in     Taiwanese OSA patients. Validation of the prediction model derived from NHIRD with the     database of National Taiwan University Hospital (NTUH) sleep center is planed to determine     the effects of different treatments on long-term prognosis.   "
91379|NCT02090010|"     Seldinger technique is a minimally invasive technique in which the practitioner accesses the     target vessel with a small bore needle, then dilates to the size required for the catheter.     Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle     that is covered with guiding sheath.      Both technique is widely used in central venous catheterization, however, few researches have     been investigated to compare success rate or complications of both methods.   "
91380|NCT02089997|"     The purpose of this study is to evaluate the safety and efficacy of sodium risedronate     tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as     to examine the status of treatment compliance - i.e., whether sodium risedronate tablets     are taken properly in accordance with the prescribed once-monthly regimen   "
91384|NCT02089945|"     Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood     delivery and is associated with poor quality of life and death. In the elderly with     considerable medical burden, a relatively new non-invasive valve replacement technique called     Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery.     However, long term changes in cognition after TAVI remain unclear and previous studies have     suggested an increased risk of cognitive decline in patients following the surgical     procedure. In this pilot study, the investigators will characterize changes in cognition,     physical capacity, overall quality of life and neuropsychiatric symptoms (depression and     apathy) over 6 months after TAVI.   "
91385|NCT02089932|"     The duration of sensory block after single dose of long acting local anesthetics is not     sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as     clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine     is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our     knowledge, the use of Dexmedetomidine in different dose levels as adjuvant to local     anesthetic was not previously reported for femoral nerve block.   "
91386|NCT02089919|"     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors     into immunosuppressed mice, preventing an assessment on the immunologic interactions and     effects of CSCs. In this study, the investigators examined the vaccination effects produced     by CSC-enriched populations from histologically distinct murine tumors after their     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic     and more effective as an antigen source than unselected tumor cells in inducing protective     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed     antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor     immunity.   "
91391|NCT02089854|"     The study is a prospective multi-center randomized control clinical trial which is sponsored     by the researchers. The purpose of this study is to determine the effectiveness of adjuvant     endocrine therapy for operable ER-beta positive, ER-alpha/PR negative, Her-2 negative breast     cancer(triple negative breast cancer, TNBC) patients. The ER-beta positive TNBC patients who     had undergone modified radical mastectomy or breast-conserving surgery were randomly (1:1)     enrolled to receive toremifene (60 mg per day for premenopausal and perimenopausal patients)     /anastrozole(1mg per day for postmenopausal patients) or observation within 4 weeks after     adjuvant chemotherapy and/or radiation therapy if necessary.The follow-up time will be at     least five years. The disease free survival(DFS) and overall survival(OS) between endocrine     group and observation group will be compared to evaluate the effectiveness.   "
91392|NCT02089841|"     Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated     malaria since 2007. Nonetheless, a report of increased proportion of patients with     parasitaemia on day 1 following treatment with artemisinin based combination therapies has     emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in     South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to     assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria     among children after five years of wide scale use of the drug in Tanzania.   "
91393|NCT02089828|"     To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral     blood mononuclear cells in treatment of critical limb ischemia   "
91394|NCT02089815|"     Prior studies have shown multifaceted falls prevention program with home-based exercise     reduced falls significantly in the community setting. The Otago exercise program has been     tested in four separated controlled trials of community living people in New Zealand. Falls     were the main outcome in each trail and were defined as unintentionally coming to rest on     the ground, floor or other lower level. Not only this combination strengthening and balance     training exercise could reduce fall but also could benefit in cost-effectiveness for fall     prevention and decrease mortality in those 80 and older. However the limitation of Otago     exercise program is that the program was needed to be trained by skill nurses or physical     therapists. There are 17 steps levels to adhere the program. As some studies have shown that     fall prevention program adherence could be as low as 10-40%. In Thailand the lack of medical     staffs are continued the problem in the community. Therefore to establish fall prevention     guideline that will be suitable and translated into the real setting, this study is aimed to     test the effectiveness of simple program home-based exercise comparing to non-simple program     home based exercise in preventing fall and improve muscle strength and balance dysfunction in     older people with mild to moderate balance dysfunction. The method is the randomized     controlled trails.   "
91395|NCT02089802|"     Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic     Drug Monitoring followed by Individual Dose Escalation.   "
91396|NCT02089789|"     Background:      - Proteins, fats, and other molecules are the body s building blocks. Many of these molecules     must have sugars, or chains of sugars, attached to work properly. People with congenital     disorders of glycosylation (CDGs) cannot attach these sugars or sugar chains properly. A     child or adult with a CDG can have symptoms in different parts of the body, including brain,     nerves, muscles, liver, and immune system. Researchers want to learn more about these     diseases to understand better what is causing the problems.      Objective:      - To learn more about CDGs.      Eligibility:      - People age 1-80 with CDG or suspected to have a CDG.      Design:        -  CDG participants will stay in the hospital 3-5 days. They will have:        -  Medical history and physical exam. They will answer questions about their CDG.        -  Blood taken several times. Their skin will be numbed, then a needle will take blood from          an arm vein.        -  Samples taken of their skin, urine, and maybe stool and spinal fluid.        -  Photos taken of their whole body. They can wear underwear and cover their eyes.        -  Brain MRI. They will lie on a table that slides in and out of a metal cylinder. The          scanner makes loud knocking noises so they can wear earplugs.        -  Abdomen ultrasound. Sound waves take images of the body from the outside.        -  Hand/wrist X-rays for young patients. They may have a full-body X-ray.        -  DEXA bone density scan. Participants will lie on a table under a scanner.        -  Echocardiogram and electrocardiogram for heart activity. Pads are stuck on the skin and          the electrical activity of the heart is recorded.        -  Tests of hearing, thinking, motor skills, and speech.        -  Children participants may have tests done under sedation if it will benefit them          directly.        -  CDG participants may have other procedures during their visit. They may have follow-up          visits every year.   "
91609|NCT02086994|"     We aim to compare carbetocin with misoprostol for the prevention of postpartum hemorrhage in     patients with severe preeclampsia. The primary outcome is postpartum haemorrhage (blood loss     of ≥ 500 ml) while our Secondary outcomes include use of additional uterotonics, need for     blood transfusion, maternal adverse drug reaction, maternal complications and maternal death   "
91397|NCT02089776|"     Background:      - People can learn to use feedback about brain activity to change that activity. Researchers     want to see if people who have had a stroke can change their brain activity by practice and     thought with feedback, and if that improves motor control. They will study brain activity in     people who have and have not had strokes.      Objectives:      - To see if people with stroke can change their brain activity and improve motor control by     practice and thought.      Eligibility:        -  Adults 18 80 years old who have had a stroke.        -  Healthy volunteers 18 80 years old.      Design:        -  Participants will be screened with a medical history, MRI, and physical exam. For MRI, a          magnetic field and radio waves take pictures of the brain. Participants lie on a table          that slides in and out of a cylinder. They will be in the scanner less than 2 hours,          lying still for up to 15 minutes at a time. The scanner makes loud noises. Participants          will get earplugs.        -  Participants will have up to 3 scanning visits and up to 3 follow-up visits within 24          weeks. Visits may include screening, MRI, functional MRI (fMRI), questionnaires, and          simple motor tests. Stroke participants may take additional motor tests, including          transcranial magnetic stimulation (TMS).        -  fMRI: During this MRI, small metal disks may be taped to the skin or a fabric glove with          small wires in it may be used to monitor hand movements. Heart rate and breathing may          also be monitored. Participants may be monitored by video and asked to perform tasks.        -  TMS: A brief electrical current goes through a coil on the scalp. It creates a magnetic          pulse that stimulates the brain. Participants may be asked to perform simple actions.          Finger or hand movements may be recorded.   "
91398|NCT02089763|"     The purpose of the study is to evaluate the efficacy and safety of PEG-BCT-100 as the     second-line therapy following sorafenib in advanced HCC patients. Another objective of the     study is to explore whether the expression of OTC and ASS are predictive biomarkers for drug     response and prognosis.   "
91436|NCT02089256|"     The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide,     on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may     change after repeated administration. The effect of liraglutide on insulin release will be     tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be     performed without medication and repeated 12 hours after first dose of liraglutide and after     3 weeks of treatment with liraglutide.   "
91399|NCT02089750|"     The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer     subjects who have chronic low back pain.      The hypothesis of this study is that custom-made shoe will improve patients' low back pain     and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will     further improve patients' low back pain and dysfunction while maintaining that improvement     during the one year study follow-up period.      Specific Aims:        1. To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and          dysfunction (Oswestry Disability Index) in patients with chronic low back pain after six          weeks of custom-made shoe orthotic use with or without chiropractic care as compared to          no care.        2. To determine the changes in perceived pain levels and dysfunction in patients with          chronic low back pain after twelve weeks of custom-made shoe orthotic use.        3. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months          following the 12 week treatment period.   "
91400|NCT02089737|"     The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be     studied.      Specifically, information will be collected on the following as events of interest: skin     disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and     cardiac disorders.   "
91401|NCT02089724|"     Erdheim-Chester disease (ECD) is a rare non-Langerhans cell histiocytosis. Diagnosis of ECD     is based on clinical symptoms, imaging and histology with infiltration of tissues by foamy     CD68 positive CD1a negative histiocytes.      Because half of the ECD patients carry a BRAFV600E mutation, we recently proposed     vemurafenib, an inhibitor of mutant BRAF, as a possible targeted therapy. We have treated     more than10 patients with refractory ECD with life-threatening manifestations associated with     the BRAFV600E mutation and observed a short and long term efficacy.      However, vemurafenib may have several side effects and long term administration of this drug     has not been evaluated. In other diseases such as melanoma, duration of administration is     usually shorter, due to bad prognosis of the disease and progression despite treatment.      As in long-term follow-up, ECD patients with vemurafenib seem to have a stable disease, we     want to evaluate the possibility of treatment interruption as this is what we do in our     current practice. Other BRAF inhibitors, such as dabrafenib, have recently been proposed for     treating BRAF mutated histiocytoses. Other BRAF inhibitor interruption treatment should also     be prospectively evaluated.   "
91402|NCT02089711|"     This study is being initiated to create a normal database including measures of optic nerve     head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg     Spectralis OCT device. The range will be determined for each structural parameter across     normal eyes in Japanese subjects, and the measurements stratified according to age.   "
91403|NCT02089698|"     To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional     phacoemulsification using the bevel-down technique.   "
91405|NCT02089672|"     Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is     introduced into the heart. These catheters can then cauterize abnormally functioning portions     of the heart muscle with the hope of returning the heart to a more effective rhythm. In the     process of performing such a procedure, called a catheter ablation, an operator must be able     to accurately sense electrical activity displayed on computer screens in different parts of     the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally     without damaging uninvolved heart structures), and accurately reassess the electrical     activity of the heart to ensure the spot in the heart has been cauterized.      When sensing electrical activity of the heart, specialized catheters produce recordings on a     computer screen known as electrograms (EGM). To produce this recording conventional catheters     commonly use a positive and negative electrode, from which the difference between the two     provides the EGM. The distance between the two electrodes varies from device to device. The     greater the distance between them, the less accurate the measurement of local electrical     activity becomes. This may result in poorly localized or excessive use of energy that could     be damaging to normal heart structures or put the patient at risk for the return or     development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with     a specialized sensing tip that uses microelectrodes that are relatively close in proximity     (<1 mm apart) with the hope of improving the sensing capability of the device.      This study will analyze the signals obtained from this FDA-approved catheter in people     undergoing a catheter ablation procedure. The study will examine signals after the procedure     is finished and will not prolong or differ the process from a standard ablation procedure.     The goal of this study is to determine the ability of the microelectrodes to distinguish     ablated, or cauterized versus non-cauterized tissue.   "
91645|NCT02086513|"     This is a phase I trial of LDE225 for the treatment of steroid-refractory chronic Graft     Versus Host Disease (GVHD).   "
91406|NCT02089659|"     This study will investigate the influence of hepatic insufficiency on the pharmacokinetics     (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate     hepatic insufficiency will be compared with that of healthy control subjects matched with     regard to mean age and weight. If a clinically meaningful increase in doravirine exposure is     observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 will     evaluate PK of doravirine in participants with mild hepatic insufficiency.   "
91407|NCT02089633|"     The propose of the study is to evaluate the maximum tolerated dose (MTD) of Oxaliplatin in     combination with pegylated recombinant human arginase 1 (PEG-BCT-100) and Capecitabine and     efficacy of this combination regimen (PACOX)in patients with advanced liver cancer.   "
91408|NCT02089620|"     Premenstrual syndrome represents a group of problems affecting most of women in reproductive     age. These problems include emotional and physical symptoms. In this study the efficacy of     oral contraceptive pills and calcium supplements in relieving these symptoms will be assessed     .   "
91448|NCT02089100|"     The previous reported phase I study allows us to prospectively define the optimal total dose     in different metastatic locations (88). However, several questions are still unanswered such     as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic     disease. Indeed, there are two different oligometastatic states: de novo, i.e. occurring at     first metastatic presentation without any previous systemic therapy; and secondary, defined     as residual disease after systemic treatment.      The investigators wish to prospectively study the role of metastases SBRT with curative     intent in de novo oligometastatic disease.      This clinical trial would be the first randomized study studying SBRT at onset of the     metastatic disease. If this trial shows a PFS improvement, it will definitively change the     standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It     will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).   "
91409|NCT02089607|"     Subjects for this study will have been diagnosed with a bulge or aneurysm in their abdominal     aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the     lower body including major organs and the legs.      The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and     customized physician-specified stent-graft with a combination of fenestrations and/or     branches to repair the aneurysm.      The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a     tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft     open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of     blood with a high risk of death and other serious complications. To avoid this risk the     aneurysm will be repaired by putting a graft in place of the aneurysm. The graft will be     inserted through arteries in the leg (called endovascular repair). This procedure uses     catheters that go inside the blood vessel to place a stent graft above and below the     aneurysm.      The upper portion of the graft includes 1 to 5 small holes (fenestrations) or cuffs (side     branches) that allow the graft to be located above the renal arteries without blocking blood     flow to them. These small holes or branches are the investigational part of this research     study. This is needed when there is not enough healthy aorta below the renal arteries. At     least one artery may also be treated with an alignment stent (small tubular stainless steel     structures) to help keep the arteries open and aligned with the fenestrations or branches.     The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will     be referred to as the Zenith Fenestrated-Branched System.   "
91410|NCT02089594|"     Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen     Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects     with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).   "
91411|NCT02089581|"     To determine whether two new oral formulations of a strong pain killer release the drug into     the body in a similar pattern as the already marketed reference capsule formulation with or     without food.   "
91412|NCT02089568|"     The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney     donation surgery prevent infection.   "
91413|NCT02089555|"     African Americans are twice as likely to develop Alzheimer's disease as white Americans, but     few African Americans are enrolled in large Alzheimer's biomarker studies. The current     proposal aims to determine the influence of Alzheimer's disease and vascular disease on     memory and aging in African Americans through modern biomarkers (spinal fluid, MRI, and     amyloid imaging), and how these may differ between African Americans and white Americans in     preparation for a large multi-center study of aging in African American.   "
91414|NCT02089542|"     Reliable identification of parathyroid glands is critical to the success of thyroid and     parathyroid surgery. In thyroid surgery, inadvertent injury to parathyroid glands may cause     temporary or permanent hypoparathyroidism (low calcium levels needing long term treatment).     In parathyroid surgery, early identification of normal and/or enlarged parathyroid glands     helps in deciding on the extent of surgery and increases the chances of postoperative normal     calcium levels.      Methylene Blue (Methylthioninium chloride, MB) is a dye that when given intravenously in high     doses, is taken up differently by thyroid and parathyroid tissue. It is currently used during     parathyroid surgery by some surgeons to help identify enlarged parathyroid glands by visual     examination alone. Such visual examination is unhelpful in the identification of 'normal'     parathyroid tissue. MB exhibits fluorescent properties in the near-infrared range (light just     beyond the visible spectrum). This can be picked up by an appropriate imaging system. This     has potential to identify and differentiate between 'normal' parathyroid, 'abnormal'     parathyroid and thyroid tissue during surgery.      The investigators have established the feasibility of the intra-operative use of a near     infra-red fluorescent imaging device called Fluobeam® and demonstrated the ability of this     device to pick up near infra-red fluorescence from human tissue after administration of     intravenous MB. Animal experiments have shown that doses as low as 0.1mg/kg of MB given     intravenously enable fluorescent visualisation of thyroid and parathyroid glands.      This study will aim to optimise the dose and timing of administration of MB in human thyroid     and parathyroid surgery and to develop a protocol which would then subsequently be assessed     for effectiveness in a multi-centred randomized controlled setting.   "
91415|NCT02089529|"     The following study investigates the role of information/expectancies in the response to     Ibumetin and placebo.      The study is a double-blind randomized controlled trial with crossover, within subjects     repeated measurements. The symptoms are measured by questionnaires. 40 patients will be     included in the study. The administrated drug is Ibumetin 400 mg.      The study does not require patients to meet in the clinic. Patients will be instructed in how     to report pain, tension and nervousness via mobile phone (Checkware AS, Trondheim,     Norway).Three days a week for 12 weeks the patients are instructed to report at 0900 AM, and     thereafter at 0910, 1100, 1300, 1500, 1700, and 1900 hrs each study day. At these times the     patients will receive a sms where they are instructed to immediately rate their pain and     stress level and report back.   "
91417|NCT02089503|"     Main Objective: The main objective of this retrospective observational study was to describe     the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study)     scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with     Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual     Acuity (BCVA), measured at 24 months (± 4 weeks).   "
91418|NCT02089490|"     The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL     protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case     of reconstructive plastic surgery.      The matric implantation will be followed by autologous skin grafting when the neodermis     formation will be observed.   "
91449|NCT02089087|"     This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects     and intravenous doses in rheumatoid arthritis patients.   "
91450|NCT02089074|"     Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack     (TIA), but studies show that adherence to the prescribed drugs is often poor. This randomised     controlled trial aims to investigate whether a systematic follow up of drug treatment using     medication reconciliation, medication reviews and patient counselling by clinical     pharmacists, improves adherence and/or decreases cardiovascular events the first three months     and the first year after TIA. Patient satisfaction will also be compared between the two     groups.   "
91451|NCT02089061|"     This purpose of this study is to assess the effects of BMS-919373 on the single dose     Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.   "
91419|NCT02089477|"     Low physical fitness may cause several life style related diseases e.g. cardiovascular     disease, cancer and type 2 diabetes. It is important to develop reliable methods for     measurement which can be used to follow the development of the physical shape both on an     individual level and on at population level.      Associated with the development of new training method known as Interval Walking we developed     an application for smartphones. The use of the application InterWalk was meant to increase     physical activity in patients with type 2 diabetes. The application should both be able to,     1) be a personal trainer when doing interval walking, and 2) measure the individual physical     fitness performed as a walking test. The latter function was developed to make the training     more personal and individal adapted, so that the training was neither too hard or too easy.      It is necessary to test the walking test against a golden standard for measuring physical     fitness and that the test in the application is able to measure and register changes in     physical fitness.      Our hypothesis is that the individual test, in the InterWalk Application is reliable and able     to register changes in physical fitness in patients with type 2 diabetes. The purpose of this     project is investigate the reliability of a smartphone-based test of physical fitness, and to     investigate whether the test is able to register changes in physical fitness during the     project time (3 month). A secondary aim is to investigate whether individual support during     the training period, affect the individual effort and time of interval walking per week.   "
91420|NCT02089464|"     A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining     active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with     standardized task oriented rehabilitation will be conducted in patients with post-stroke     motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6     months later.   "
91421|NCT02089451|"     This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic     properties (the exposure of the trial drug in the body) of faster-acting insulin aspart     (FIAsp) after different injection regions and routes of administration in healthy subjects.   "
91422|NCT02089438|"     Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and     islet hormones. The study examines this in relation to breakfast, lunch and dinner over an     entire 24h study period by the use of three different DPP-4 inhibitors and placebo.   "
91423|NCT02089425|"     This is a randomized, double blind, placebo controlled, parallel group study to assess the     efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate     acute pain associated with ankle strain or sprain.   "
91424|NCT02089412|"     This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet     doses administered either after an overnight fast or in combination with a standard high-fat     meal in healthy subjects.   "
91425|NCT02089399|"     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug     interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.   "
91426|NCT02089386|"     Treat Barrett's esophagus (BE) patients with tamoxifen to Barrett's metaplasia as measured by     changes in Barrett's esophagus appearance by endoscopy and histology as well as changes in     SOX2 and CDX2.   "
91427|NCT02089373|"     The purpose of this study is to conduct a study on genetic pathology, obtaining of pure     cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for     diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or     less. Recently, confocal laser endomicroscopy has been introduced for real-time     histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy     using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells     in biopsy samples.   "
91428|NCT02089360|"     Blood sample is prospectively taken from consecutive patients underwent coronary angiogram in     our center, after getting informed consent from the patients. Serum level of advanced     glycation end products (AGEs) was measured and the clinical features of patients (including     angiographic results) were entered into our database. Clinical follow-up was performed for     all patients, and the relationship between AGEs and paitents' outcome were analyzed. Further     intervention will be adjusted according to the results,including clinical and basic research     in lab.   "
91444|NCT02089152|"     Study hypothesis:      Prevention programme for melioidosis can reduce incidences of overall hospitalization due to     infectious diseases and due to culture-confirmed melioidosis in diabetic population in     northeast Thailand      This study is a prospective single-blind multicentre stepped wedge cluster randomized     controlled behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast Thailand.   "
91429|NCT02089347|"     The aim of the study is to generate additional safety and immunogenicity data to support the     registration of the product in Japan.      Primary objectives:        -  To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of          diphtheria and tetanus booster response rate (proportion of subjects with booster          responses) and seroprotection rate (percentage of subjects with antitoxin concentrations          ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents          11-12 years of age.        -  To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in          terms of booster response rate (proportion of subjects with booster responses) at 28          days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.      Secondary objectives:        -  To further evaluate the immune response of the study vaccines against diphtheria,          tetanus and pertussis antigens.        -  To assess the safety of the study vaccines after one injection in Japanese adolescents          11-12 years of age.   "
91430|NCT02089334|"     The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a     target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to     assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal     cell cancer (Stage 2).   "
91431|NCT02089321|"     The purpose of this study was to investigate whether combined assessment of lumbopelvic     control during sagittal and frontal plane motion (using two common clinical observational     assessments) discriminates between people with and without LBP than single plane assessment     alone. It was hypothesized that the two tests used in combination (multiplanar) would perform     better than each test used independently (single planar) in accurately discriminating patient     cases from healthy controls.   "
91432|NCT02089308|"     The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine     patch to that of a reference formulation following repeated applications   "
91433|NCT02089295|"     To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation     under fed conditions in healthy volunteers.   "
91437|NCT02089243|"     Background: There are a variety of treatment options for medically refractory medial temporal     lobe epilepsy. Evidence from randomized trials indicates vagus nerve stimulation therapy can     be used as a proven therapy for medically refractory medial temporal lobe epilepsy. Resective     surgery is one of the most commonly used methods to treat medically refractory medial     temporal lobe epilepsy. The aim of this study is to compare the effects of vagus nerve     stimulation therapy and resective surgery in the treatment of the medically refractory medial     temporal lobe epilepsy.      Methods/Design: In this article, we report the design and protocol of a randomized controlled     trial to treat medically refractory medial temporal lobe epilepsy with vagus nerve     stimulation therapy or resective surgery. In total, 40 patients aged 12 to 60 years with     medically refractory medial temporal lobe epilepsy will be assessed. There are two treatment     groups. These patients are randomly assigned to be in one of the following two treatment     groups, i.e. 1) undergo temporal lobe resection group, 2) receive vagus nerve stimulation     therapy group. The primary outcome is to assess whether vagus nerve stimulation produces a     reduction in mean monthly seizure frequency that is comparable to resection at 3 months, 6     months, 9 months and 12 months of follow-up. The secondary outcomes include the     neuropsychological, seizure severity, seizure type, quality of life, mood assessment,     operative and postoperative complications and long-term side effects, compared to resection.      Discussion: The result of this trial will assess the efficacy of using vagus nerve     stimulation therapy or resective surgery to treat medically refractory medial temporal lobe     epilepsy, and to determine a better therapy for treating medically refractory medial temporal     lobe epilepsy.   "
91438|NCT02089230|"     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of     MEK162 that can be given to patients with advanced leukemia.      The goal of Phase 2 of this clinical research study is to learn if MEK162 can help to control     AML in older patients with advanced leukemia. The safety of this drug will also be studied.   "
91439|NCT02089217|"     Carotid revascularization for primary prevention of stroke (CREST-2) is two independent     multicenter, randomized controlled trials of carotid revascularization and intensive medical     management versus medical management alone in patients with asymptomatic high-grade carotid     stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no     endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with     embolic protection versus no stenting. Medical management will be uniform for all randomized     treatment groups and will be centrally directed.   "
91440|NCT02089204|"     Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies in terms of its     epidemiology, pathology, and treatment outcome . It is endemic in China and is one of the     major public health problems. Concurrent radiotherapy and chemotherapy is the primary     treatment for patients with NPC. Despite such aggressive treatment, many patients with     locally advanced NPC still develop locally recurrent disease. Since local control is directly     related to patient morbidity and mortality in NPC, there is a strong need to identify methods     to further improve treatment outcome for NPC.      One strategy to improve local control is to escalate the dose of radiotherapy. This is     because local control has been shown to be directly related to the radiotherapy dose. Several     different techniques, including brachytherapy, stereotactic radiosurgery, and dose-painting     intensity modulated radiotherapy (IMRT), have been used to increase radiotherapy dose.     However, due to the large number of critical anatomic structures near the nasopharynx,     dose-escalation in NPC can also lead to increased toxicities. One technique that has achieved     dose-escalation with minimal increase in toxicity is simultaneous modulated accelerated     radiation therapy (SMART). The main challenge for such treatment is to identify the     appropriate tumor volume to receive the high-dose radiotherapy. Conventional dose-escalation     is conducted using computed tomography (CT) to identify the gross tumor volume (GTV).     However, recent progress with F-18 fluorodeoxyglucose positron emission tomography/computed     tomography (18F-FDG-PET/CT) in treatment planning allows more accurate tumor volume     delineation. We hypothesize that the use of PET/CT in treatment planning can improve     dose-escalation radiotherapy for NPC which in turn can improve therapeutic efficacy while     reducing toxicity. PET/CT imaging of tissue hypoxia using [F-18]fluoromisonidazole (FMISO),     the most widely used nitroimidazole imaging agent.Given that there has been no clinical     trials directly comparing conventional chemoradiotherapy to CT-guided dose-escalation     chemoradiotherapy or PET/CT guided dose-escalation chemoradiotherapy in locally advanced     NPC.This was a study to evaluate the role of FMISO-PET hypoxia imaging for predicting     survival in NPC,our study aims to compare the local control, overall survival and toxicities     of the three treatment regimens..   "
91441|NCT02089191|"     The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus®     (DACP) compared to MyDay® after 12 hours of lens wear.   "
91442|NCT02089178|"     The purpose of this study is to compare the effect of total intravenous anesthesia and     inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in     patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous     anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.   "
91445|NCT02089139|"     Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is     mainly based on MR imaging, showing MODIC I or II changes in patients with concordant     symptomatology. The treatment of discogenic low back pain is nevertheless difficult:     intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited     efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with     notable risk of side-effects.      In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in     patients with disabling discogenic pain is assessed.   "
91446|NCT02089126|"     The study objective is to demonstrate the superiority and safety of the combination therapy     (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride     monotherapy in patients with type 2 diabetes.   "
91447|NCT02089113|"     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular     lens implantation.   "
91452|NCT02089048|"     Phase I, open-label study in 15 healthy adult subjects receive 6 mg of auranofin orally once     every 24 hours for 7days. Blood samples will be taken for 17 weeks following the last dose of     auranofin for determination of terminal phase pharmacokinetic parameters. Stool samples will     also be obtained for the measurement of gold.   "
91453|NCT02089035|"     The consumption of milk and dairy products is recognised as an essential part of a healthy     diet as it represents an important source of key micro- and macronutrients. Nevertheless,     there is still a widespread conviction that the overall high energy density and concentration     of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects,     contributing to the progression of cardiovascular disease, obesity and diabetes.      Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an     achievable strategy in order to reduce the amount of SFA present in dairy products.      The aim of this project is to observe the effects of three types of dairy products (UHT milk,     cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on     CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of     developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products     will affect vascular function and CVD biomarkers.   "
91454|NCT02089022|"     The aim of this study was to evaluate the effect of ice and shortwave diathermy in different     regions of lower limb neuromuscular response and balance.   "
91455|NCT02089009|"     1. To compare quality and usability of images taken by two different camera-systems without          dilating the pupil.        2. To compare the retinal vessel diameters based on the images of to different          camera-systems.        3. To detect changes in retinal vessel diameters while pregnancy and after delivery.   "
91456|NCT02088996|"     Chemotherapy-induced peripheral neuropathy (CIPN) implies sensory or deficits pain, loss of     motor functions and impaired proprioception which in turn may affect balance and fine motor     skills. It is mainly subjected to the peripheral parts of the extremities, may be transient     or permanent.CIPN is a common, potentially severe and often dose-limiting side effect after     patient exposure of numerous classes of antineoplastic agents including platins, taxanes,     vinca alkaloids, bortezomib and thalidomide. At present, no evidence based treatment of CIPN     is available. A variety of different drugs or drug combinations have been clinically tested     but the value of these treatments is uncertain. Many patients with CIPN are referred to     physiotherapy but still this treatment is more based on clinical experience and tradition     than scientific evidence. In a nonrandomized study, sensory electrical stimulation(MC5-A     Calmare ®) was tested on 16 persons.The electrodes were placed on the hand and foot and     intensity was gradually increased and given daily for 10 days. Pain was reduced 20% in     numeric pain score for 15 of the 16 participating patients.      Our clinical experience indicates that treatment with long wave diathermy (LWD) may decrease     CIPN symptoms. This treatment produces electromagnetic radiation according the capacitor     method with heightened circulation and heat which is assumed to reduce pain. Interferential     Therapy (IT) is an electro-physical method which is based on an electric field in the painful     area through four electrodes or vacuum cups placed on the skin. Increased blood circulation     and pain relief is supposed to be achieved. IT use two different intermediate frequencies     (1001-10000 Hz) alternating currents in the painful area. The treatment effect correspond to     the gate control-theory; inhibition of pain signals in small diameter fibers by activity in     large-diameter Aβ-fibers by spinal neurons. Some studies have shown effect in treating pain     with interferential currents when pain is experimentally induced or induced by cold in     otherwise pain-free volunteers, when compared to a control or placebo.      The hypothesis of this study is that the combination therapy longwave diathermy on high power     and interferential currents gives better results than longwave diathermy on low power.   "
91457|NCT02088983|"     People with schizophrenia tend to have problems with attention and concentration. Studies     found that these patients are unable to block or gate out non-relevant and distracting     information (e.g., noises). This may lead to brain overload. Cognitive abilities like     concentration, memory, and learning may worsen. This ability to filter sensory information     has been linked to a gene that affects the way nicotine acts in the brain. Patients with     schizophrenia have a high rate of cigarette smoking. 60% to 90% smoke compared with 25% of     the general population. It has been suggested that these patients may use nicotine to improve     their ability to block out distracting information. Brain wave activity (EEG) in response to     sounds has been proved useful in understanding this gating problem. The present study uses     EEG measures and performance tasks to find out what a new nicotine-like treatment, which will     be added to ongoing treatment medications, does to gating and cognition. It is hoped that     this new treatment will improve the way in which patients process information, as this may     help them in day-to-day activities.   "
91458|NCT02088970|"     The corneal collagen cross linking is currently used in the treatment of keratoconus but this     procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal     cross linking in association with the antibiotic treatment could result in a reduction of the     duration of epithelial complete healing of the cornea.   "
91459|NCT02088957|"     The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin,     both administered intravenously, in adult subjects experiencing nonconvulsive electrographic     seizures.   "
91468|NCT02088840|"     All patients undergoing autologous or allogeneic stem cell transplant (SCT) for any     underlying disease will be monitored for severe infections by gram negative bacteria (SIGNB)     during the engraftment period. The follow up will be stopped at 4 months from the day of     transplant. About 50 transplant centers will be involved in the study.   "
91646|NCT02086500|"     The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given     during air medical transport to a level 1 trauma center in patients at risk of hemorrhage is     associated with lower 30 day mortality.   "
91460|NCT02088944|"     Many studies reveal that infliximab (IFX, an immunoglobulin gamma-1 antibody)can response     well to Crohn's Disease(CD) patients who are intolerant of corticosteroids and     immunosuppressant,or steroids-dependent .More over,A complex fistula in CD is an indication     for early IFX therapy in conjunction with surgical drainage.Some papers claim that IFX may     prevent enterectomy CD patients from relapsing. Those with risk factors which at diagnosis     associated with  disabling disease include age < 40 years, initial need for steroid     therapy, and the presence of perianal disease are recommended to use IFX early.      IFX is approved by State Food And Drug Administration(SFDA) in 2007 ,but the safety is still     controversial by then.Some studies proclaim that the side effect may be infections,acute     infusion reactions,anaphylactic reactions,autoimmunity,drug-induced lupus,congestive heart     failure,abortion and demyelination,etc.      So some problems still need to be settled as follows:1)all the the infliximab dates are from     other countries,there is rare date from the Chinese,especially the large quantity of random     controlled studies and the CD patients with enterectomy.2)despite of the large number of     databases from the international ,when to stop and the predictor of the response is still     obscure.3)The high cost of IFX may hinder its applications,especially for the moderate to     severe active CD patients who take mesalazine and/or immunosuppressant to maintain     remission.In addition,the pathogenic age segments in the occurence of CD: from 15~ 50 years     old ,so they suffer from the disability of self-improvements.      The main object of the clinical trial is to complete the database of Chinese CD patients     ,especially the safety and efficacy of IFX and those with enterectomy.Then we can record the     clinical manifestations of the moderate to severe CD patients with the use of IFX or     conventional drugs,including the dose,course and Concomitant treatment.We can also study the     predictor and the appropriate time to stop using IFX .We can make the mode of cost-benefit     help the patients choose the best project.   "
91471|NCT02088801|"     In this second phase of the multicenter study the investigators are going to evaluate the use     of three different videolaryngoscopes in patients undergoing elective surgery requiring     general anesthesia with intubation. The investigators are hypothesizing that these three     videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases     using a difficult airway simulation with extrication collars. As the gold standard, a     standard Macintosh blade is being used for comparison.      The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480     patients.   "
98564|NCT01996033|"     The purpose of this observational study is to further evaluate the safety and performance of     the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled     hypertension in clinical routine practice.   "
91461|NCT02088931|"     The purpose of this study is to test the safety of the experimental therapy of a single     infusion of Regulatory T cells (Tregs). The investigators want to find out what effects, good     or bad, Tregs will have on the kidney transplant patients.      There are different types of T cells. This study uses Regulatory T cells (Tregs), which are     found in the blood and are part of the immune system that stops other immune cells from     working. Tregs help to turn off the immune system after other immune cells have finished     tackling outside infections, and Tregs keep the immune system in check so that the body does     not attack itself. The researchers are hoping that, by giving an infusion of Tregs that the     attack on the kidney can be stopped and kidney function will be stabilized. It is not known     if the Treg experimental therapy can stop the inflammation in the kidney.      In this study, the researchers will take some of Tregs from the patient, multiply them in the     laboratory, and then infuse them back into the patient. The procedure used to multiply Tregs     is an experimental process performed in the laboratory. Similar procedures done with mice     have been shown to reverse inflammation but it is not known whether the results will be the     same in humans. This therapy has not yet been done in humans outside of a research study.   "
91462|NCT02088918|"     A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety     and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a     Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy     Male Subjects   "
91463|NCT02088905|"     The aim of the current proposal is to determine if the PCIT treatment manual can be     successfully utilized for preschoolers with ASD and disruptive behavior (across a range of     intellectual functioning levels) and to evaluate its ability to significantly decrease     measures of problem behavior. It is hypothesized that the current manual will require few     modifications for use with ASD and that, in comparison to a wait-list control group, families     who undergo PCIT training will evidence significant gains on measures of parenting stress,     child externalizing behaviors and compliance to parental requests. To address the pilot study     aims, we will recruit a total of 20 families of children with ASD (ages 2.6-6.11 years) whose     children are already receiving intensive, one-on-one behavioral treatment services (15-30     hours per week) but no structured parent training. Families will be randomized to either     intensive services + PCIT or intensive services alone (wait list control). Assessments will     be completed at baseline, mid-treatment (10 weeks post baseline), post-treatment (20 weeks     after the baseline assessment) and long-term follow-up (12 weeks post-treatment). PCIT     families will attend 20 weekly, one-hour coaching sessions. Both active treatment and     wait-list control families will continue to receive intensive ABA services in the home or     community. Control families will receive PCIT training after 16 weeks on the wait-list. The     aims of the pilot study are:        1. To assess the utility of the current PCIT treatment manual with preschoolers with ASD          and disruptive behavior and their parents;           Hypothesis 1: The current PCIT treatment manual will be able to be utilized with          families of children with ASD with only minimal modifications.           Hypothesis 2: Families of children with ASD will consistently attend PCIT sessions.        2. To determine if PCIT with this population will result in an increase in appropriate          parent behaviors and a subsequent decrease in targeted child behaviors (e.g., direct          assessment of noncompliance, behavior rating scales).      Hypothesis 3: Families receiving PCIT training will evidence statistically greater decreases     on measures of disruptive behavior, quality of parent-child interactions and parental stress     than families on the wait-list control group.      Hypothesis 4: Gains attained at 20 weeks will be maintained at a 12-week post-treatment     follow-up.   "
91464|NCT02088892|"     TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin     (BCG) vaccine at standard and high dose.   "
91465|NCT02088879|"     The chest compression depth decreases over time after starting continuous chest compression     due to the rescuers' fatigue.      The investigators hypothesized that the frequency parameters from surface electromyogram from     each muscle during chest compression may reflect the muscle fatigue of the rescuers.      Then investigators can identify which of the body are mainly used and get tired by continuous     chest compression using surface electromyogram.   "
91466|NCT02088866|"     The purpose of this investigation is to evaluate if topically applied lidocaine, in the form     of lidocaine patches, reduces the burden of chronic subjective tinnitus in a consistent and     measurable way.   "
91467|NCT02088853|"     Human beings are 'omnivores' meaning that all principal components of food (i.e. the     macronutrients: carbohydrates, fat, proteins) can be assimilated by the gastrointestinal     tract. When the gut mucosa is exposed to dietary changes it adjusts its functional behaviour.     For example, a fatty diet demands certain digestive mechanisms, whereas others are needed to     take care of a carbohydrate rich diet. Such dietary induced changes in appearance and     functionality of the small intestinal mucosa have been described in animals but only little     is known about it in man. The present project aims at elucidating in man if a 2 weeks diet     dominated by either fat or carbohydrates, but with similar energy content, is associated with     changes in the small intestinal mucosal appearance and metabolic signalling capacity.   "
91469|NCT02088827|"     The rates of sedentary activity are increasing. Studies have shown that time spent on doing     sedentary activities is an independent risk factor for cardiovascular disease. Prior studies     have shown that interrupting inactivity improved the body's handling of blood glucose and     gene expression. The investigators plan to explore this further by examining the effects of     interrupting 4 hours of inactivity with 2 minutes of moderate intensity exercise every 20     minutes on the following metabolic parameters: blood pressure, cortisol, C-Reactive Protein,     glucose and insulin levels.   "
91470|NCT02088814|"     Background: Previous studies have found considerable rates of posttraumatic stress disorder     (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with     injuries following accidental trauma. In consequence, secondary preventive efforts (early     interventions) should be undertaken to minimize such long-term deleterious consequences in     children.      Aims: The proposed study aims at examining the effect of a newly developed, standardized     early psychological intervention in reducing posttraumatic maladjustment and in enhancing     health-related quality of life in children ages 1 to 4 years with acute burn injuries.      Method: The study is designed as a randomized controlled trial within a stepped procedure.     First, eligible children will be screened 5 to 7 days post injury by means of a standardized     measure for their risk of developing PTSS. After a baseline assessment, children at risk will     then be randomly allocated to either a control group (standard medical care) or an     intervention group. Participants of the intervention group will be provided with the     standardized EPICAP 1-4 intervention which uses established cognitive-behavioral techniques     and is directed to the parents. The intervention consists of two face-to-face sessions (at     baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6     weeks after the first session). Blinded follow- up assessments with standardized parent     report measures will be conducted at 3 and 6 months post injury. The primary outcome measures     are child PTSD and PTSS, secondary outcome measures include child behavior and health-related     quality of life. In addition, a variety of socio-demographic, medical and parental variables     will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6     months to make sure that the screening procedure is valid.   "
93344|NCT02064270|"     The aim of this study is to assess the prevention of incision healing complications in     patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated with     either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of care     dressings.   "
91472|NCT02088788|"     Radiation exposure to operator is an occupational hazard of invasive cardiologists. During     radial access for diagnostic catheterization, a new radio-dense arm board is advertised to     reduce operator radiation exposure. The investigators randomize patients to a new radio-dense     armboard versus a standard radio-transparent armboard during diagnostic catheterization and     measure radiation exposure to the operator. Both groups have a radio-dense pelvic shield in     place. The investigators hypothesize that operator radiation dose will be decreased by use of     the radio-dense armboard.   "
91473|NCT02088775|"     This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in     determining the radiation dose delivered with radioactive spheres to patients with liver     metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures     dose before and after delivery of radioactive spheres to the liver may help determine     radioembolization dose and plan the best treatment for liver metastasis or primary liver or     biliary cancer.   "
91474|NCT02088762|"     Objective: To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm     surgical margins on survival of the patients compared with 2 cm surgical margins.      Background: Early recognition and appropriate excision play a crucial role in management of     malignant melanoma, while the size of surrounding normal skin that should be excised is area     of controversies.      Methods: The investigators will conduct a retrospective population-based survey in patients     with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins     in the investigators center. For both groups, the patients' charts reviewed for data     including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness,     tumor type, presence of ulceration, findings of sentinel nodes, local recurrences,     locoregional metastases, disease free survival and overall survival were calculated for both     groups.   "
91475|NCT02088749|"     The purpose of this study is to compare the 6- and 12-month weight changes associated with     lifestyle interventions delivered in a large group or small groups of participants. It is     hypothesized that participants receiving treatment in a small group will have greater weight     loss than those assigned to a larger group.   "
91476|NCT02088736|"     In patients with out-of-hospital cardiac arrest in Singapore, investigators aim to assess the     benefit of introducing a resuscitation protocol including the use of intravenous (IV) access     and/or intraosseous (IO) vascular access in the pre-hospital setting.      The assumption is that low vascular access rates could be due to difficulty of setting IV     cannulas in the field due to certain factors like poor lighting or space constraints. Thus,     by introducing a protocol including IO access for difficult IV cases, success rates for     vascular access will be higher and this might lead to higher survival rates.      This will be a study comparing 'IV+IO' and 'IV alone' protocols in patients with cardiac     arrest managed by Singapore Civil Defence Force (SCDF) emergency ambulance service. The trial     will recruit 400 patients over 1 year. Each of the 30 SCDF ambulances will provide both     'IV+IO' and 'IV alone' treatments in 2 consecutive phases of 6-months in order to allow for     all ambulance crew a chance to be trained on usage of IO. Currently, IO insertion is the     accepted standard of care in Singapore General Hospital, Department of Emergency Medicine.   "
91477|NCT02088723|"     The purpose of this study is to determine if the elevation of the head of the bed in patients     with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators     will do a standard polysomnography and see if the patients are included analysing the     criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do     the second polysomnography but this will be with a elevation of the head of the bed (15 cm of     elevation of the bed doing a inclination). Then the investigators will compare the data of     apnea-hypopnea index in the standard polysomnography versus the index with the elevation of     the head of the bed.   "
91478|NCT02088710|"     The purpose of this study is to evaluate the role of patients' response expectations for     nocebo side effects, quality of life and adherence during adjuvant endocrine treatment (AET).     Furthermore, this study analyses the effects of a structured treatment information on     patients' satisfaction with information, response expectations, knowledge and adherence.   "
91479|NCT02088697|"     The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and     sertraline Tablet in Japanese healthy male subjects.   "
97876|NCT02005055|"     This prospective study evaluates the outcome of surgical excision with adjuvant     high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are     recurrence rate, scar quality and physical complaints.   "
91480|NCT02088684|"     The purpose of this trial is to explore the clinical utility of the three investigational     agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class     I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with     fulvestrant.      This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a     dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant;     LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant.      The Phase II portion of the study will be a randomized study to assess the anti-tumor     activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120     with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally     advanced or metastatic breast cancer.      Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer     will be enrolled.   "
91481|NCT02088671|"     The objective of this clinical study is to investigate whether the NeuroSENSE is an adequate     monitor of hypnotic depth-of-anesthesia (DOA). Therefore, this study will investigate whether     the information provided by the NeuroSENSE Monitor can help in assessing the hypnotic effect     of anesthetics in adult patients undergoing general anesthesia.   "
91482|NCT02088658|"     The purpose of this study is to test the usefulness of an intervention that combines     technology with diabetes education and skills training. This study has been designed     specifically for African Americans with poorly controlled type 2 diabetes.   "
91497|NCT02088463|"     The study was conducted to the following purposes        1. To investigate the effect of lumbar mobilization on muscle activity in postpartum          mechanical low back pain.        2. To investigate the effect of lumbar mobilization on pain intensity in postpartum          mechanical low back pain patients.        3. To investigate the effect lumbar mobilization on functional disability in postpartum          mechanical low back pain patients.        4. To compare between the effects of lumbar mobilization, tactile stimulation (placebo          treatment) and traditional treatment in postpartum mechanical low back pain patients.   "
91483|NCT02088645|"     The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of     patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin     analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on     more than 90 % of medullary thyroid carcinomas.      In the pilot (phase 0) study we will correlate the tumour detection rate with the surgery and     histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will     be performed in order to determine the kidney protection protocol and starting activity for     the dose escalation study in the following, dose escalation (phase I) study. In the phase I     study we will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC.     Furthermore, correlation with tumour radiation dose and treatment response as well as organ     radiation doses and maximal tolerated dose will be performed in order to allow prospective     individual patient tailored therapy planning.   "
91484|NCT02088632|"     IncobotulinumtoxinA (Xeomin®) is a neurotoxin which inhibits the release of certain chemicals     at the nerve terminals. It blocks cholinergic transmission at the neuromuscular junction by     inhibiting the release of acetylcholine from motor neurons. In addition it blocks the release     of Substance P (SP) and Calcitonin Gene Related Peptide (CGRP) from C fibers involved in pain     perception. This study is designed to see if Xeomin® is superior to placebo in the treatment     of medically refractory trigeminal neuralgia (TN). Subjects will be asked to maintain an     attack diary throughout the study. They will also be asked to attend 4 office visits; Visit     1- Screening Visit, Visit 2- Injection Visit, Visit 3- Follow-Up Visit and Visit 4- Final     Visit. At the end of the study the active (Xeomin®) and placebo groups will be compared to     see if one group had better relief than the other.   "
91485|NCT02088619|"     The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and     acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy)     modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2)     obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes     in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion,     mood, and well-being across time (baseline, 3 & 9-months). It is hypothesized that the QOLT     will promote improvements in autonomic function, reduced arrhythmia frequency, and improved     psychological well-being.   "
91486|NCT02088606|"     A prospective, multicenter, interventional study to collect confirmatory evidence on the     safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment     of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated     radiofrequency ablation.   "
91487|NCT02088593|"     Medical students score higher than the general population on measures of depression, anxiety,     fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase might     contribute to these problems. From an internal validity standpoint, first year medical     students are an ideal group to study. The majority of the students will be matched on     variables such as education, age, and intelligence. However, more importantly, they have a     nearly identical life style when it comes to factors such as schedule, living conditions,     level of stress, and timing of stressors. The specific aim and hypothesis is:Medical students     randomized to sleep hygiene counseling plus simulated dawn will report less depression,     anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized     questionnaires) than students randomized to just sleep hygiene counseling.   "
91488|NCT02088580|"     This study will attempt to study the effect of adjunctive chronotherapy (wake therapy, sleep     phase advance, and bright light therapy) on acutely depressed inpatients. The investigators     will attempt to recruit individuals admitted to the acute inpatient unit and study the     results of the treatment on depressive symptoms, and suicidality.   "
91489|NCT02088567|"     The overall objective of this study is to evaluate the effectiveness of dHACM in reducing     scar tissue formation in total knee replacement patients.   "
91490|NCT02088554|"     To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.   "
91491|NCT02088541|"     This is a randomized, multicenter, open-label, Phase 2 study of the SINE compound, Selinexor     given orally versus specified investigator choices (one of three potential salvage     therapies). Patients age ≥ 60 years with relapsed/refractory AML of any type except for AML     M3, after one prior therapy only, who have never undergone and who are not currently eligible     for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.   "
91492|NCT02088528|"     Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of     medications, disease severity and poor compliance. Surgical treatment is likely to be a more     practical solution.      The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma     drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical     study.   "
91493|NCT02088515|"     The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is     a second-generation platinum compound that is more active against squamous cell carcinoma of     the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.   "
91494|NCT02088502|"     The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and     Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy.     Investigators assume that Theophylline plus N-acetylcysteine is more effective than     Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for     elective coronary angiography or angioplasty and allocate them to each of the mentioned     treatments from 24 hours before to 48 hours after administration of contrast material.     Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25%     of the baseline value.   "
91495|NCT02088489|"     Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with     the same safety.   "
91496|NCT02088476|"     Candidemia has emerged as an important cause of hospital-associated blood-stream infection in     children. The purpose of this study was to identify differences in distribution of candida     species, risk factors, treatment, and clinical outcome of candidemia in children. This study     in children ≤18 years with blood culture proven candidemia identified between 2004 and 2012.     Analyses included the determination of causative candida species, resistance to antifungals     and clinical outcome, as well as the identification of potential risk factors associated with     candidemia.   "
91498|NCT02088450|"     The Syst-Eur Trial is a concerted action of the European Community's Medical and Health     Research Programme. The trial is carried out in consultation with the World Health     Organization, the International Society of Hypertension, the European Society of Hypertension     and the World Hypertension League. Syst-Eur is a multicentre trial designed by the European     Working Party on High Blood Pressure in the Elderly (EWPHE), to test the hypothesis that     antihypertensive treatment of elderly patients with isolated systolic hypertension results in     a significant change in stroke morbidity and mortality. Secondary endpoints include     cardiovascular events, such as myocardial infarction and congestive heart failure. To be     eligible patients must be at least 60 years old and have a systolic blood pressure averaging     160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must give their informed     consent and be free of major cardiovascular and non-cardiovascular diseases at entry. The     patients are randomized to active treatment or placebo. Active treatment consists of     nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide     (12.5-25 mg/day), as necessary. The patients of the control group receive matching placebos.     The drugs (or matching placebos) are stepwise titrated and combined in order to reduce     systolic blood pressure by 20 mmHg at least to a level below 150 mmHg. Morbidity and     mortality are monitored to enable an intention-to-treat and per-protocol comparison of the     outcome in the 2 treatment groups.   "
91499|NCT02088437|"     Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip     fractures are a significant problem for the older people, the hospital system and community     as a whole because of the increasing numbers of fractures and the cost of hospitalisation and     ongoing care. After one year, less than half of all people with a hip fracture can walk as     well as they did before the fracture. Physiotherapy in the acute hospital setting is an     integral part of patient care, although the intensity of physiotherapy a patient receives is     variable and the optimal number of treatment sessions per day remains unknown. Studies in     other patient groups have shown that increased physiotherapy can improve patient outcomes by     increasing muscle strength and mobility. It can also reduce the negative effects of bed rest     such as muscle wasting, blood clots in the lungs or leg veins and chest infections such as     pneumonia. This study aims to investigate the effectiveness of an intensive physiotherapy     program in hip fracture patients to further understand this and the effect it has on patient     function.      In this research the investigators will randomly allocate patients into 2 groups; usual care     and intensive physiotherapy. The usual care group will have physiotherapy treatment daily     whereas the intensive physiotherapy group will have an additional daily treatment by a     physiotherapist as well as a daily treatment by an allied health assistant. The objectives     are to achieve better functional outcomes in the patient's hospital stay (ie improved     mobility), reduce the time for patients to be physically ready to go home, increase the     number of patients able to go directly home or to fast stream rehabilitation (rather than a     slow stream option).      If increased intensity of physiotherapy is found to improve patient's mobility outcomes, this     research will provide the confidence to endorse a change to current clinical practice.   "
91500|NCT02088424|"     THE INSULIN RESISTANCE IN RECURRENT ABORTION   "
91501|NCT02088411|"     The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was     to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with     moderate-to-severe osteoarthritis (OA) of the knee.   "
91502|NCT02088398|"     This study will be an open-label, randomized, single dose, 3-period crossover PK study. This     study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1,     subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects will     be administered Treatment A, B, or C according to the randomization schedule.        -  Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state        -  Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state        -  Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state   "
91516|NCT02088216|"     Objective: To evaluate whether long-term oral N-acetylcysteine as an expectorant drug can     reduce the frequency of acute exacerbations of patients with non-cystic fibrosis     bronchiectasis and improve their quality of life.      Methods: Patients with non-cystic fibrosis bronchiectasis will be randomly assigned to the     observer group (participants receive 600 mg of oral N-acetylcysteine BID for 12 months) or     the control group (participants receive oral tablet BID for 12 months). The primary endpoint     was the frequency of acute exacerbations.      Expected results: Compared with the control group, the frequency of acute exacerbations of     the observer Group will decrease significantly.      Hypothesis: Long-term oral N-acetylcysteine can reduce the frequency of acute exacerbations     of patients with non-cystic fibrosis bronchiectasis and improve their quality of life.   "
91517|NCT02088203|"     Safety and tolerability of a soy-protein Russian Tarragon complex versus a placebo.   "
91518|NCT02088190|"     The investigators hypothesize that the improvements in insulin sensitivity, beta (β)-cell     function, and inflammation will be greater, and the improvement in sarcopenic obesity will be     less, in younger versus older individuals after substantial weight loss induced by sleeve     gastrectomy bariatric surgery.   "
91503|NCT02088385|"     Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder     hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides     significant ease of administration compared to the combined conventional technique of     saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray     powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic     bases, where the combined conventional technique has limited efficacy. Building up on     preliminary work from small single-arm studies, the investigators aim to establish the     efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the     combined conventional technique. The investigators propose a pilot study to establish our     centre's feasibility of performing a prospective, randomized, parallel group trial, which     compares the efficacy of Hemospray with the combined conventional technique, in the     endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding     peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate     (defined as endoscopically verified cessation of bleeding for at least 5 minutes after     endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following     the initial hemostasis) and its safety profile.   "
91504|NCT02088372|"     Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population   "
91505|NCT02088359|"     Infants are exposed to either continuous bright light continuous near darkness or     unstructured combination of the two. The investigators primary objective is to determine the     effectiveness cycled light and near darkness on growth in preterm infants.   "
91506|NCT02088346|"     The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation     system in making decision on IV thrombolysis.   "
91507|NCT02088333|"     The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC)     can increase the percentage of patients who receive colorectal cancer screening. The mCRC     intervention will include a tablet-based patient education program, clinic protocols to     facilitate the ordering of CRC screening tests, and electronic messaging with patients to     promote screening. The investigators hypothesize that participants randomized to mCRC will be     more likely to complete screening compared with those randomized to the control arm of the     study. Additionally, the investigators hypothesize mCRC will increase several intermediate     outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict     completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add     little to the overall cost of screening.   "
91508|NCT02088320|"     The focus of the present study is to further develop an echocardiographic technique to     measure cardiopulmonary transit time (PTT) and pulmonary blood volume (PBV) using ultrasound     contrast.      The Specific Aims for the present study are as follows:        1. To compare echocardiography-based PTTs and cardiac MRI-based PTTs obtained using a          'peak-to-peak' method        2. To further quantify the relationship between echocardiographically-derived PTT, using          Optison, and existing echocardiographic methods used to determine ventricular function        3. To measure the reproducibility of echocardiographically-based PTT using Optison.   "
91510|NCT02088294|"     The childhood obesity epidemic, which falls disproportionately on Latino adolescents,     represents a major public health threat to the current generation of youth, and therefore to     the health of the nation overall. This project directly addresses the role of psychosocial     stress in promoting obesity and metabolic disease risk, and investigates the role of the     mind-body CAM intervention of guided imagery in both reducing stress and promoting healthy     lifestyle behaviors that could dramatically improve the metabolic health of today's youth.   "
91511|NCT02088281|"     The potential effect of indigo naturalis on the immune system is unknown. The investigators     hypothesize that the therapeutic effect of indigo naturalis in psoriasis may involve     inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines,     thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.   "
91512|NCT02088268|"     The purpose of this study is to focus on the effect of platelet-rich-plasma on diabtic ulcer     foot, as adjuvant treatment along with the standard care of chronic diabetic, and evaluate     the efficiency and the clinical application of PRP on serious wound healing.   "
91513|NCT02088255|"     The purpose of this study is evaluate the effects of walking training with partial body     weight support on static (floor) and dynamic (treadmill) surfaces in individuals with     hemiparesis due to stroke. For this purpose, two training protocols will be employed in three     experimental groups: G1 will do the walking training with partial body weight support on     static surfaces and G2 will do the walking training with partial body weight support on     dynamic surfaces   "
91514|NCT02088242|"     Exposure to heat stress can compromise the physiological and cognitive function and be life     threatening, particularly in a military setting. Various strategies of precondition to heat     stress that have been explored in the past proved to be inapplicable. We aim to examine the     influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a     human model using a heat tolerance test. This will be achieved by a double-blind, placebo     controlled supplementation trial, exposing human subjects, before and after consuming     Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate     exercise in a heated chamber.   "
91515|NCT02088229|"     This longitudinal interventional case series will utilize the patients at the University of     Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema.     Baseline measures will be taken which include structural assessments such as circulatory     capacity utilizing fluorescein angiography, in addition to retinal layer integrity and     thickness using high resolution optical coherence tomography. Also, functional assessments     such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation,     perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and     compared with historical controls to ensure that currently accepted interventions are safe.     Finally, potential confounding variables for DME including those related to the eye, systemic     factors, and patient demographics will be recorded to assess the influence of these variables     on treatment response.      The primary objective is to develop hypotheses that might better explain the retinal     structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in     eyes receiving treatment for diabetic macular edema (DME).   "
91519|NCT02088177|"     This is an 8 week, outpatient research study testing the use of long-acting naltrexone     (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is     effective in treating dependence on opiates and opioids, and in treating dependence on     alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains     enough medicine in each injection to last for one month. One way it works is by blocking the     effects of opiates, including opiates released by the body in response to drugs and alcohol.     In this study, we are interested in testing the effects of Vivitrol in people with marijuana     dependence.      Individuals participating in this study will receive two Vivitrol injections, each given four     weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one     side. Participants will attend clinic visits two times a week during this 8-week study for     medical management for drug use and for monitoring of physical and psychological health.   "
91520|NCT02088164|"     To determine the long-term survival outcome of subjects who had various PSA levels at     screening   "
91545|NCT02087839|"     Primary Objectives:        -  To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity,          and duration of treatment-emergent adverse events in patients with poor prognosis lung          cancer.        -  To record the extent, frequency and duration of any tumor responses to this treatment          regimen and assess whether ZD6474 augments the efficacy of radiation therapy in          non-small cell lung cancer patients.        -  To determine the recommended phase II dose of ZD6474 for future clinical studies with          radiation therapy.      Secondary Objectives:        -  To determine the effects on metabolism and angiogenic factors by positron emission          tomography (PET) scan/computed tomography (CT) scan , Vascular endothelial growth factor          (VEGF), and circulating endothelial cell levels in patients treated with ZD6474 and          radiation therapy.   "
91521|NCT02088151|"     Laser photocoagulation of the retina targeting the outer layers is an established therapy for     proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein     occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes.     However, collateral damage occurs and scotomas can result when using conventional lasers with     pulse duration of 100ms and more. This is particularly relevant for laser treatments of the     macula where the main therapeutic effect results from stimulation of the retinal pigment     epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent     experimental research with new laser devices using much shorter pulse duration has shown that     photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively     targeted, hence the term selective retinal pigment epithelium laser therapy (SRT).     Investigators hypothesize that SRT is equally effective as standard laser photocoagulation     for macular disease but minimizes local visual field defects.      In this study, patients with central serous retinopathy, macular edema from diabetic     microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration     will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.   "
91522|NCT02088138|"     The purpose of this study was to determine the effects of Functional Electrical Stimulation     (FES) on physical performance and quality of life of patients in cardiac rehabilitation.   "
91523|NCT02088125|"     The purpose of the study was to analyze the effect of IS and BS on dynamics ventilatory and     asymmetry of the chest wall in patients after stroke .   "
91524|NCT02088112|"     This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability,     pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with     MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists     of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or     metastatic NSCLC subjects   "
91525|NCT02088099|"     Mayo Clinic has been funded by the National Institute on Disability Independent Living &     Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center     continuously since 1998. We have successfully competed for this funding because we     consistently produce high quality research and because we provide comprehensive team-based     rehabilitation services to people with TBI and their families over the continuum of care that     is associated with superior outcomes.      Lack of access to specialized TBI care is the most common need identified by individuals     after they are hospitalized for TBI. The upper Midwest has some of the highest populations of     rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and     are more likely to have limited access to rehabilitation services after acute care. Explosive     advances in communication technology have brought tele-medicine to the forefront of health     care. The CONNECT trial will test the effectiveness of using modern technologies - such as     phone consultation and other telehealth communication systems - to deliver specialized brain     rehabilitation resources remotely to patients and providers in the upper Midwest. The groups     targeted by the CONNECT trial are:        -  Individuals recently hospitalized with TBI;        -  Their families;        -  Their local health care and other providers (primary care providers, psychologists,          therapists, social service providers, job counselors).      The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND,     and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD),     and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome     can be improved by providing care with no face-to-face contact. The trial will study whether     outcomes over three years are different in the group receiving this remotely provided model     of care compared to a matched group that receives usual care in their communities.      The desired long term outcome of this study is to increase our capacity to provide care and     to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals     with TBI and their families.   "
91526|NCT02088086|"     The Fit Study is a three-year, cluster-randomized controlled trial that will evaluate the     impact of school-based body mass index (BMI) screening and reporting on child health.     Seventy-nine California schools will be randomized to one of three groups: 1) BMI screening     and reporting, 2) BMI screening, and 3) no BMI screening or reporting (control).     Investigators will assess the impact of BMI reporting on students' BMI trajectories over     three years. Investigators will also assess the impact of BMI screening on weight-based     teasing, feelings of stigmatization, and weight-control behaviors among students.   "
91527|NCT02088073|"     It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in     maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium     levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was     established during the open-label acute phase versus no difference between each ZS dose     (highest to lowest) versus placebo control (null hypothesis).   "
91540|NCT02087904|"     A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study     to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of     ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.   "
91528|NCT02088060|"     Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's     population. Current antipsychotics are only partially effective, and their use is often     associated with serious side effects. Cannabidiol is a natural counterpart of the     psychoactive component of marijuana, delta-9-tetrahydrocannabinol. While cannabidiol has no     psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid     signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled     clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute     paranoid schizophrenics the investigators showed a significant clinical improvement in all     symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol     displayed a significantly superior side-effect profile. This study is to evaluate the     efficacy and safety of this novel treatment option in comparison to placebo and olanzapine,     an established second generation antipsychotic in the treatment of acute schizophrenia and     schizophrenia maintenance therapy, in a four-week clinical trial.   "
91529|NCT02088047|"     This study is designed to pilot an intervention technique to reduce the self-stimulating     behaviors seen in individuals with autism spectrum disorders using intervention with     ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and rocking,     can interfere with the individual's ability to interact with their peers. Participants will     wear the pellets for four week and measures with taken again. Another group of participants     will not get the pellets. Both groups will be tested at the beginning and end of the study.     Any variations in self-stimulating behaviors will be documented through parent report,     Observational data. The investigators hypothesize that they will see changes in self-     stimulating behaviors as a result of the strategic placement of the ProFoveate™ pellets on     the ears of one group of the participants.   "
91530|NCT02088034|"     The overarching goal of this project is to develop and test a behavioral intervention     delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.   "
91531|NCT02088021|"     The purpose of this clinical investigation is to evaluate the use of the Portico ALC Delivery     System to place a transcatheter aortic valve through an alternative access site, specifically     subclavian/axillary or TAo.   "
91534|NCT02087982|"     The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary     diagnostic process to determine the medical, psychological, and functional capabilities of an     elderly person, in order to develop a coordinated and integrated plan for treatment. It     represents the first stage of the most appropriate care for elderly people who are frail or     who cannot perform at least three daily tasks unaided.      It has been shown that the integration of CGA in the decision-making and care management at     hospital improves inpatient's health and functional status, and reduces mortality rate and     healthcare expenditures. The effects of CGA in daily practice of general practitioners remain     unknown.      Implementation of a systematic CGA for every older old community-dwellers performed by a     general practitioner remains yet difficult because of number of issues. First, although the     number of older old community-dwellers keeps increasing, the number of health care     professional with geriatric skills does not. Second, CGA is a complex and time-consuming     process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone the     care of all frail older old community-dwellers due to their limited number. An implication of     non-geriatricians in CGA is therefore required.      Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best     compromise could be the use of a two-step approach. The first step is the identification by     non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening     tool, and the second step is a CGA by geriatricians with a diagnosis purpose.      None of existing tools used for screening is adapted to the population of elderly people who     visit general practitioners.Thus, healthcare professionals working in ED need a simple,     standardized and brief geriatric assessment (BGA) to identify as soon as possible frail older     old community-dwellers requiring specialized geriatric care.      The investigators hypothesized that a BGA older old community-dwellers carried out by a     general practitioner could predict the adverse health events (i.e. hospitalization,     institutionalisation, medical consultations and death) occurring during a 6-months follow-up     period before the evaluation.   "
91535|NCT02087969|"     The purpose of this study is to determine the effectiveness of dry needling in improving     ankle range of motion and functional outcomes. There have been an increasing number of     studies on dry needling as an intervention for pain but none thus far that have studied     functional outcome measures of the ankle. The study will include healthy male subjects     between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling     of the triceps surae, triceps surae stretching only, dry needling and stretching. The     subjects who receive dry needling as an intervention will have the trigger point identified     and dry needling performed while under musculoskeletal ultrasound visualization. The subjects     will undergo pre and post intervention testing including Lower Quarter Y-Balance test,     passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion,     deep squat, multisegmental flexion as well as Marx Activity Level Scale. There will be 3 days     between the initial testing/intervention and follow up. These outcomes will be the primary     variables of interest. Ultrasound, Y balance testing, self stretching, and range of motion     measurements are safe and pose no risk to the subject. Dry Needling has been found to be very     safe and effective in the hands of physical therapists with a calculated risk of adverse     events to be less than 0.04%.   "
91536|NCT02087956|"     The purpose of this study is to determine whether priority-based patient navigation will     improve patient satisfaction, quality of life (QOL), and depression when compared to     screening-and-referral for socioeconomically disadvantaged women's health patients with     depression. The investigators goal is to establish patient-driven, effective, generalizable,     and disseminable interventions to reduce depression-related disparities and improve outcomes.   "
91537|NCT02087943|"     A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with     moderate to severe atopic dermatitis   "
91538|NCT02087930|"     Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest     a crucial role for enteric microflora in oral tolerance development. An altered composition     of intestinal microflora results in an unbalanced local and systemic immune response to food     allergens. There are qualitative and quantitative differences in gut microbiota composition     in children with food allergy. These findings support the concept that specific beneficial     bacteria from human intestinal microflora, designated probiotics, could restore intestinal     microflora homeostasis and prevent or treat FA. The investigators demonstrated that it is     possible to stimulate oral tolerance acquisition in children with cow's milk allergy using     the most studied probiotic in the pediatric field, Lactobacillus rhamnosus GG (LGG). The main     study aim is to identify an innovative strategy to induce oral tolerance acquisition by a     selective manipulation of intestinal microflora.   "
91539|NCT02087917|"     To determine the efficacy of HS-25 (5, 10, 20 or 30 mg) in reducing low density     lipoprotein-cholesterol (LDL-C) levels after a 4-week period of treatment in adults with     primary hypercholesterolemia.   "
91541|NCT02087891|"     Psychosocial stress increases the risk for a multitude of diseases, including obesity,     hypertension, and cardiovascular disease. Stress may also result in increased utilization of     health care services. In the workplace, stress leads to emotional exhaustion, job     dissatisfaction, lower productivity and impaired performance. Stress management programs and     those based on mindfulness meditation have gained popularity in recent years. The purpose of     this study is to evaluate the feasibility of an 8-week web-based mindfulness stress reduction     program and its effectiveness in reducing work related stress and improving well-being in a     large corporate call center.   "
91542|NCT02087878|"     To collect and store blood and biopsy samples obtained from CD or UC patients exposed to     adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of     identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.   "
91543|NCT02087865|"     This 24-week study will examine the sensitivity of functional MRI to detect brain changes     caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk     for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be     eligible for this study. Participants without a family history of AD will also be enrolled to     serve as a control group.   "
91544|NCT02087852|"     This registry will help us develop better methods of:        -  Preventing these cancers        -  Diagnosing these cancers        -  Treating these cancers   "
91546|NCT02087826|"     The purpose of this research study is to examine whether specific genes (e.g. SLC16A11)     affect how human beings respond to food and a medication that is commonly used to treat type     2 diabetes. The food the investigators will be studying is specially prepared to contain     protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The     investigators hypothesize that physiological responses to the meal and to the medication will     differ between carriers and non-carriers of genes associated with type 2 diabetes.   "
91547|NCT02087813|"     Neuromyelitis Optica (NMO) is a rare, devastating demyelinating disease of the central     nervous system (CNS) that has different causes and treatments from the more common     demyelinating disease multiple sclerosis (MS). Current NMO therapies are nonspecific and have     varying and often suboptimal benefit. The investigators will evaluate whether use of     alpha1-antitrypsin (A1AT, an FDA-approved medication for patients with congenital deficiency     of A1AT associated with emphysema) can benefit acute attacks of NMO, improving patient     disability and quality of life.   "
91548|NCT02087800|"     This study aims to characterize the effect of smoking on stress-induced allopregnanolone     (ALLO) response in women by menstrual phase. The investigators hypothesize that women who     smoke will have a blunted ALLO response to stress.   "
91549|NCT02087787|"     The goal of this study is to develop and test the effects of a marrow transplant (BMT) Legal     Clinic established through a medical-legal partnership (MLP) in an adult blood and marrow     (BMT) transplant setting. This will be a 2-arm randomized, controlled clinical trial, in     which the intervention group of patients will participate in a BMT Legal Clinic and the     control group is provided standard information regarding legal resources.   "
91550|NCT02087774|"     The investigators hypothesized that the addition of 6 minutes of exercise during the school     day would increase physical fitness in elementary school students as demonstrated by longer     distances run in 2 minutes and a decrease in heart rate at the end of the exercise.   "
91551|NCT02087761|"     The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and     differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.      The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.   "
91552|NCT02087748|"     The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel     (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed     Onset Muscle Soreness.   "
91553|NCT02087735|"     The purpose of this cross over pilot study is to investigate the urinary catabolites of     Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.   "
91554|NCT02087722|"     KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy     to improve sleep quality in over 55 years old primary insomnia patients. This is a 2nd     bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean     patients.   "
91555|NCT02087709|"     The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers     associated with insulin resistance, metabolic profile and body composition in women with     Metabolic Syndrome.   "
91556|NCT02087696|"     The purpose of this project is to evaluate the efficacy of Tocilizumab (TCZ) given as     monotherapy in patients with active rheumatoid arthritis (RA) according to EULAR response at     24 weeks after treatment initiation.      The study design is an intervention study, uncontrolled, multicenter, prospective, 32-weeks,     two cohorts of patients with poor compliance or with any contraindication or intolerance to     methotrexate.      One cohort naive to previous biological therapy and the other one treated previously with a     biological treatment.   "
91557|NCT02087683|"     The purpose of this study is to determine the effects of vitamin D supplementation in     patients with heart failure and vitamin D deficiency on ventricular function, inflammatory     cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum     parathyroid hormone and calcium.   "
91558|NCT02087670|"     Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in     patients with chronic heart failure after participating in an exercise program and compare     them baseline and 2 months, with another group who underwent an educational program.   "
91559|NCT02087657|"     By doing this study, researchers hope to learn the following:        -  The safety of hyperbaric oxygen administration in the setting of the autologous          transplant        -  The effects of hyperbaric oxygen administration on neutrophil count recovery and          engraftment   "
91560|NCT02087644|"     A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild     to moderate allergic asthma not sufficiently controlled on inhaled steroid.      Altogether 170 patients, randomized to two treatment groups will be included. Key outcome     measures are patient reported parameters on their asthma   "
91561|NCT02087631|"     Study Purpose:      The purpose of this clinical trial is to determine if extended-release quetiapine in a dose     of 300 mg daily is tolerable to people with relapsing remitting and progressive MS. The     investigators will also determine if the investigators can increase the dose up to 300 mg     daily within 3 days in people with relapsing remitting MS and within 2 weeks in people with     progressive MS. The investigators will determine if at least two thirds of study participants     tolerate the drug well enough to continue it for 4 weeks. Tolerance will be determined     separately for people with relapsing remitting and progressive MS. People with progressive MS     may be less tolerant of side effects because of greater underlying brain injury from MS.     Alternatively, people with progressive MS may gain more benefit from the improved sleep that     usually occurs with use of quetiapine or they may be more willing to tolerate some side     effects. This clinical trial will determine the maximally tolerated dose for future trials of     this drug.      The number of participants in this study will depend on the tolerability at each dose tested.     A maximum of 18 people with relapsing remitting MS and 18 people with primary or secondary     progressive MS will be included.      Study Design:      The cohort expansion design (3+3) is used to determine toxicity-based dosing. This design is     used in oncology phase I trials as it is guided by patient safety and minimizes the number of     participants exposed to toxicity (Ivy et al. 2010). Maximum toxicity is defined as 33% or     less. In this model, three patients will comprise the initial cohort. In the absence of DLT     treatment may be escalated to the next higher dose in the next group of three patients.     However, if one of three patients reaches DLT the cohort is expanded to six patients to     verify that the toxicity rate has not exceeded or reached 33%. When the toxicity rate exceeds     or reaches 33% in a cohort, this dose is deemed the maximum administered dose and a lower     dose will be used in the next group of three patients. Patients with RRMS and progressive MS     will be evaluated in separate groups using different dose schedules.   "
91588|NCT02087280|"     After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require     re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as     lack of the patient's compliance and motivation to recover. However in studies, psychological     relapse predictors explain only a minor part of the variance in relapse risk. Metabolic     phenotyping has clinical value to predict weight course in obese patients and we assume that     it could also be clinically relevant in patients with AN. We hypothesize that in patients     with a dissipative but not with the thrifty phenotype, positive energy balance during     refeeding causes an over proportional rise in energy expenditure, counteracts continuous     weight gain during inpatient treatment, and increases relapse risk within one year after     discharge. Thus we believe that metabolic phenotype as a biological parameter has prognostic     value for the disease course in AN.   "
91562|NCT02087618|"     This is a pilot study to examine the feasibility of a formal 30-minute daily program on a     tablet computer (simply a tablet) in subjects with mild cognitive impairment (MCI). The     purpose of the program, known as Kodro Solution, is to increase physical activity, maintain     social interaction, improve nutrition and exercise cognitive skills using a tablet. In     addition to feasibility, outcome measures will include: (a) health-related quality of life,     (b) self-esteem, (c) activities of daily living, (d) socialization, (e) mood, and (f)     cognition. Study participants must have a study partner who can assist them with training on     use of the tablet and the Kodro Solution program.      Fifty (50) study subjects and their study partners will be recruited at the Wien Center. A     delayed start design will be utilized. Study subjects will be randomly assigned to either     active treatment (Kodro+) or delayed treatment (Kodro+D). Active treatment with Kodro     Solution will be initiated at the baseline visit for Kodro+ subjects and 12 weeks after     baseline for Kodro+D subjects. The 12-week period without tablets will serve as a control.     Active treatment with Kodro Solution will continue for 36 weeks for the Kodro+ subjects and     24 weeks for the Kodro+D subjects. For both groups, the outcome measures will be assessed at     baseline, week 12 and week 36. The lagged design will facilitate enrollment and enable the     assessment of a dose effect.   "
91563|NCT02087605|"     The objective of this work is the development and validation (reliability and validity) of     the Automatic image analyzer to assess it retinal vessel caliber (ALTAIR) platform to analyze     and validate its utility in different clinical settings.      Methods / Design Design : In the first phase , will be a cross- sectional study and a second     phase will be a prospective observational study with annual follow-up for 4 years. The study     will be conducted in primary care including 386 subjects. Main measurements: blood pressure,     carotid intima-media thickness using carotid ultrasound , central blood pressure and wave     velocity pulse by SphygmoCor system, Cardio-ankle vascular index (CAVI) by VASERA® VS1500 ,     evaluation of hypertrophy ventricular using a digital ECG and renal injury . Retinal vascular     evaluation will be done by a non-mydriatic TOPCON TRCNW200 getting focused papilla, nasal and     temporal and developed by software images automatically calculate the thickness of the     retinal vessels , the arteriovenous index, the vascularized area and branching pattern . For     validation software retina intra and inter - observer variability , the correlation of the     tool measurement with AVindex , and concurrent validity with parameters of vascular structure     and function and target organ damage and association analysis will analyze the different     parameters of the estimated retina and evolution or appearance of new lesions in the target     organs.      Discussion The validation of the tool contribute to the analysis of retinal vessels improved     reliability by reducing the intervention of the observer and further validate the use of more     information than the previously used , especially surface vascularization and vessel     branching patterns .   "
91564|NCT02087592|"     BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian     cancer during their lifetime. There is evidence from the literature that for sporadic breast     cancer disease risk and the course of disease can be significantly influenced by physical     activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized     multicenter feasibility trial is that a structured life-style intervention program with     exercise training and mediterranean diet is feasible and improves the nutritional and fitness     status as well as the weight, the quality of life and stress reacting capacity.   "
91565|NCT02087579|"     The purpose of this study is to gather information about the steady-state plasma     concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at     various dose levels and at different time points after dosing. In addition, comparison of     capillary drug concentrations vs. venous drug concentrations will be performed for     aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and their relevant     metabolites.   "
91566|NCT02087566|"     Renal failure patients were treated with linezolid (LZD) for proven or suspected infections     by multiresistant Gram-positive cocci. The aim of this study is to determine if dose     adjustment of LZD is needed as a function of renal impairment or not, especially that a     significant component of LZD is eliminated unchanged in urine.   "
91647|NCT02086487|"     whether Nilotinib at the two sequential dosage forms will induce quicker and deeper response     in those patients, and if FISH on PB (Peripheral blood) would be an effective way to monitor     response compared to conventional cytogenetics on bone marrow (BM) sample   "
91567|NCT02087553|"     The investigators hypothesize that the storage-damaged red cells are responsible for some of     the adverse effects of transfusion. In this observational study, the investigators will     measure various laboratory parameters both before and after transfusion in a pediatric     intensive care unit to determine at what duration of storage is there laboratory evidence of     refrigerator storage damage.      The investigators hypothesize that increasing storage time of packed red blood cells (PRBCs)     transfused will be associated with increasing non-transferrin-bound iron (NTBI),     pro-inﬂammatory cytokine concentrations, and enhanced microbial growth in vitro in pediatric     patients.   "
91568|NCT02087540|"     To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in     hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each     monotherapy.   "
91569|NCT02087527|"     The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to     antibiotic treatment during the first 48 hours of admission to the hospital in patients with     cellulitis and its impact in the duration of the stay.   "
91570|NCT02087514|"     This study will determine the minimal duration of red blood cell (RBC) storage that leads to     increases in circulating non-transferrin-bound iron in healthy human volunteers     post-transfusion. The results from this study will help guide national guidelines for     appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food     and Drug Administration (FDA) criteria. The overall objective of this research is to improve     the safety of refrigerated storage of red blood cells before transfusion.   "
91589|NCT02087267|"     The objective of the PMCF is to collect outcome information on patients suffering from     symptomatic degenerative disc disease or degenerative spondylolisthesis requiring 1- or     2-level lumbar or lumbar-sacral spinal fusion with posterior instrumentation and therefore     receiving the icotec CF/PEEK Pedicle System in combination with the icotec CF/PEEK TLIF Cage     ETurn™.   "
91590|NCT02087241|"     The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects     with advanced NSCLC.   "
93363|NCT02064023|"     This study is investigating whether insulin treatment with the insulin pump or with multiple     daily injections (MDI) gives better outcomes for mother and baby in pregnant women with     pregestational diabetes. Participants will be randomized to use either the insulin pump or     MDI.   "
91571|NCT02087501|"     Clinical Investigation Design A prospective, open-label, non-randomized, interventional     clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.      Investigational Device The Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its     designated Delivery System.      Purpose The purpose of the study is to evaluate the safety and performance of the Horizon™     AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac     aneurysms. The results of this study will be used as supportive data for CE Marking     submission in the European Union (EU).      Objectives The primary objectives of the study are to evaluate the safety and performance of     the Horizon™ AAA Stent graft System.      Primary End Points Safety endpoints include proportion of patients free from device related     Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance     endpoints include successful delivery and deployment of the device; and absence of the     following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft     occlusion, conversion to open surgery, rupture and stent graft migration.      Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac     aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular     access techniques and devices.      Treatment All patients will be treated by implantation of the Horizon™ Abdominal Aortic     Aneurysm Stent graft System.   "
91572|NCT02087488|"     This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular     acupuncture(AA) for primary insomnia(PI) .   "
91573|NCT02087475|"     Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although     multiple treatment modalities including surgery, radiotherapy and chemotherapy have been     developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable     advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus     adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase     III mode.   "
91574|NCT02087462|"     This multicenter randomized controlled trial (RCT) will evaluate the therapeutic     effectiveness and health-economics of electroacupuncture for sciatica due to intervertebral     disc displacement in 3 compared groups: electroacupuncture, electroacupuncture plus traction,     electroacupuncture plus traction and medication.   "
91575|NCT02087449|"     Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population   "
91576|NCT02087436|"     The primary purpose of this study is to measure the postoperative changes in bone mineral     density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard     length Taperloc Complete Reduced Distal stem.   "
91577|NCT02087423|"     A study to assess the Effects of MEDI4736 in Patients With Locally Advanced or Metastatic Non     Small Cell Lung Cancer in terms of efficacy, safety and tolerability   "
91578|NCT02087410|"     measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy     levels   "
91579|NCT02087397|"     This will be an open-label, non-randomized, multi-center, patient sponsored study of     Adipose-Derived Stromal Vascular Fraction cells (AD-SVF) implantation delivered into the     corpus cavernous in patients with Erectile Dysfunction.      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the disease pathology of patients with     diagnosed Erectile Dysfunction.   "
91580|NCT02087384|"     This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo     vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex     with men) who were successfully treated for high grade AIN.   "
91581|NCT02087371|"     This is a prospective, multicenter, non-interventional, observational study of a cohort with     a biological plasma and urine samples collection for the study of prognosis factors of     cardiac complications after liver transplantation   "
91582|NCT02087358|"     This 3 weeks study examines the correlation between stress and alcohol using an ecological,     prospective design.   "
91583|NCT02087345|"     Dental erosions, the chemical dissolution of enamel without bacterial involvement, are     considered to be an established complication of gastroesophageal reflux disease (GERD) by the     Montreal global consensus statement. Given the high prevalence of dental erosions and the     absence of any pH-impedance data or medical management guidelines for GERD-associated dental     erosions, reflux characteristics will be characterized using questionnaires, endoscopy and     esophageal pH-impedance testing, in successive patients dental erosions referred by dentists     for evaluation of GERD. For assessment of the role of additional factors besides H+ activity     in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for     analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions     will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg     twice-daily, which is prescribed to all patients.   "
91584|NCT02087332|"     Study hypothesis is that the time from randomization to the increase of natriuresis (%), time     to standardization of natriuresis daily profile, blood pressure profile and the percentage     reduction of central hemodynamic parameters will be relatively changed over the study period     by more than 15%.   "
91585|NCT02087319|"     The purpose of study is to examine the advantage of PRP on hair loss and male pattern     baldness. The investigators will inject PRP into the scalp regions where with little or no     hair, and evaluate the effect and efficiency of PRP on human hair growth.   "
91586|NCT02087306|"     This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW)     for the treatment of AdV infection detected during asymptomatic AdV viremia or during     symptomatic AdV infection. After completing a screening assessment to confirm study     eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on     Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will receive     BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2 mg/kg     BIW, not-to-exceed a total dose of 200 mg/week.   "
91587|NCT02087293|"     Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the     safety and effectiveness of treatment for patients taking FDA-approved medications for one of     four common chronic conditions (diabetes, hypertension, insomnia, depression), with     integrated management support by a pharmacist.      Specific Aim 2: To measure the reach, effectiveness, adoption and implementation of this     integrated module for adult primary care patients in the Brigham and Women's Primary Care     Practice-Based Research Network.   "
91591|NCT02087228|"     The purpose of this study is to evaluate the shape, size and appearance of the inside of the     uterus six months following an endometrial ablation procedure. Half of the participants will     have their ablation performed with a hydrothermal ablation device and the other half will     have their ablation performed with a device that uses radiofrequency energy.   "
91592|NCT02087215|"     Boron as a naturally occurring element has some metabolic and inflammatory actions. The     antibacterial activity against gram negative bacteria is also known. Boron deficiency is     shown to be related with impaired wound bone healing in rats. Therefore, special wound care     formulas containing boron may have some positive effect on wound healing of the patients with     diabetic foot ulcers.   "
91593|NCT02087202|"     NMDA receptor is administered and postoperative remote hyperalgesia is investigated.   "
91594|NCT02087189|"     This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD     lead.   "
91595|NCT02087176|"     A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus     antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell     Lung Cancer Patients   "
91596|NCT02087163|"     The purpose of this study is to use clear aligners to measure tooth movement and length of     treatment.   "
91597|NCT02087150|"     The objective of this study is to determine whether Eustachian tube dilation in conjunction     with medical management or medical management alone is effective for treating Eustachian tube     dysfunction.   "
91598|NCT02087137|"     Normal aging is associated with decline in some aspects of memory, and this can be a risk     factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches     positive adaptation to age-related memory changes, including strategies for minimizing the     everyday impact of normal memory change and positive lifestyle change to maximize brain     health. Prior research has shown that the Memory and Aging program is effective in increasing     participants' knowledge about memory, use of memory strategies, and confidence in memory     function, as well as adoption of healthier lifestyle practices and reduction in intention to     use unneeded health care resources.      Although not one of the stated goals of the program, informal feedback from participants     suggests that the educational content and skills training in the Memory and Aging Program has     led some participants to change behaviours in ways that lead to significant improvements in     their everyday functioning. For example, graduating participants often volunteer examples of     how they have applied what they have learned to succeed in everyday memory tasks such as     learning a new name or keeping track of future plans. Based on this participant feedback, it     is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging Program     participants may lead to positive behaviour changes that, in turn, lead to improved everyday     functioning. The present study will test this hypothesis using a randomized controlled     pretest-posttest design.   "
91607|NCT02087020|"     Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after     knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is     recommended in early infections (< 4 weeks) and stable implants. Aims: To define the success     rate of DAIR in early infections and to identify predictors for success. Material and     methods: In a retrospective cohort study we included patients with hip- or knee     arthroplasties reoperated for an early PJI at Danderyd Hospital 2007-2012. Logistic     regression analysis was used to identify risk factors affecting success rate. Primary outcome     variable was the success of the DAIR treatment. Secondary outcome variable vas risk factors     for treatment failure.   "
91608|NCT02087007|"     This study will be conducted in accordance with the local regulation of New Drug Application.     Overall duration of this trial will be 3 years after approval of KFDA.      Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in     period, 4 weeks double blind period and 1 week safety follow up period   "
91599|NCT02087124|"     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.     Identification of a simple diet-related method will possibly result in reduction of CVD in     healthy as well as high-risk subjects.      The aim of this project is to investigate if there is a dose-response effect of whey protein     consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and     apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose,     insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and     metabolomics. Also satiety feeling will be measured.      Investigators hypothesize that whey protein (10 or 20g) consumed 15 minutes prior to a     fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more and in a     dose-dependent way compared to placebo (water) consumed prior to the meal in subjects with     MeS.      The investigators research will hopefully contribute to a better understanding of how PPL can     be modified in a simple manner. It will promote innovation to the food industry for     development and production of healthy food products, which can be applied in the fight     against CVD in the background population in general and high-risk people in particular. Thus,     the results of this project can impart knowledge of great importance both to the national and     international food industry as well as the healthcare systems.   "
91600|NCT02087111|"     Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very     high chance of developing fatal complications of their disease unless they receive effective     treatment. Unfortunately the best drugs that are currently available to treat genotype 3     hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with     advanced liver disease and therefore a large number of patients who have failed treatment are     waiting for new, better drugs. Currently there are no treatments available for these     patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which     works very well in these patients. In patients with genotype 3 hepatitis C small scale trials     and laboratory studies show that some patients do respond quite well and others respond a     little bit when given telaprevir. In patients who have exhausted all other treatment options     the investigators speculate that telaprevir treatment may help some patients by clearing     their infection. The purpose of this study is to see if telaprevir can help these patients     and to determine if the investigators can predict in advance which people can be helped.   "
91601|NCT02087098|"     This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect     of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics     (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with     antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of     Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life     measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system     (EQ-5D-5L).   "
91602|NCT02087085|"     This study will assess the safety and efficacy of the brimonidine intravitreal implant in     patients with geographic atrophy due to age-related macular degeneration.   "
91654|NCT02086396|"     This study aimed to evaluate the effect of weight loss diet combined with pumpkin seed flour     consumption on diet improvement, weight loss, and glucose and cholesterol reduction in obese.   "
91685|NCT02085993|"     Cross-sectional study, observation made by healthcare professionals of subjects or     caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after     training with the home administration training pack. Further observations can also be     recorded in the study if made within 16 weeks of enrolment. Data will be collected from the     subjects' dose diary at their first standard of care visit to ensure there were no problems     with administration while not at the clinic.   "
91603|NCT02087072|"     The primary objective is to develop a sustainable practice model emphasizing home visits by a     collaborative physician and pharmacist team to decrease unplanned emergency department visits     and hospital readmissions at 30 and 90 days for high-risk home bound patients. Secondary     objectives include (1) tracking the number, type, and severity of adverse drug events (ADE)     and potential adverse drug events (pADE) that occur following hospital discharge and (2)     resolving any identified ADE and pADE within 7 days of hospital discharge.      Adult patients will be scheduled for a home visit by the Healthy at Home Columbus program at     the time of hospital discharge. The home visit will occur within 7 days of hospital discharge     and will consist of a complete hospital and medication review by a physician or nurse     practitioner and a pharmacist (including all lab tests, imaging studies, medication changes,     and proposed plan of care at the time of discharge). The investigators hypothesize these home     visits will reduce 30 and 90 days hospital readmission rates and ED visits.      The number of emergency department visits and unplanned hospital readmissions will be tracked     at 30 and 90 days following discharge from the hospitalization that led to study enrollment.     A comparison cohort of patients discharged in the 12 months prior to study initiation will be     used to compare the effectiveness of the home visit program. The number and type of adverse     drug events (ADE) and potential adverse drug events (pADE) that occur during transitions of     care will also be characterized. All ADE and pADE will be resolved during the initial home     visit and will be classified based on severity. All ADE and pADE will be evaluated     independently by two pharmacist reviewers; each reviewer will independently assign a severity     rating to each ADE and pADE.   "
91604|NCT02087059|"     This is an open-label, multicenter clinical study in order to collect and examine data     concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis     (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.   "
91605|NCT02087046|"     The purpose of the proposed study is to demonstrate the safety and efficacy of the Totally     Implantable Deep Brain Stimulation System in the ventral intermediate (VIM) nucleus of the     thalamus implanted for the treatment of tremor due to essential tremor. This study will be     included in the Pre-Market Approval Application to support the safety of this device in use.   "
91606|NCT02087033|"     it is a prospective, randomized, double-blinded, crossover study on the use of an association     of omega 3 fatty acids, astaxanthin, vitamin E and hawthorn (ritmonutra) in subject affected     by symptomatic supraventricular ectopic beats without structural heart disease.      The study will evaluate the reduction of the number of supraventricular ectopic beats and     symptoms related.   "
92860|NCT02070640|"     The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to     assist in real-time identification of anatomy during cholecystectomy (gallbladder removal).     We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction     during cholecystectomy.   "
91610|NCT02086981|"     Primary objectives are to define incidence and prevalence of Delirium in an elderly     population admitted to the Department of Orthopedics and Traumatology and, in the     postoperative phase, in the high Dependency Unit as well as to determine the presence of risk     factors. Secondary objectives are to determine mean hospital stay, rates of complications as     well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery     and cognitive outcomes at 1, 3 and 12 moths follow-up.   "
91611|NCT02086968|"     The primary objective of this study is to evaluate the treatment response of Injectafer vs.     oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric     Bypass patients may demonstrate to be inappropriate for oral iron therapy.   "
91612|NCT02086955|"     The purpose of the study is to evaluate the effectiveness of a nurse led intervention for     high risk patients with diabetic foot ulceration and/or amputation.      The effectiveness is defined in two ways 1) as a reduction in complication rates (time till     ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in     hospital readmissions for foot-related complication (one year survival probability: failure =     readmission for ulceration recurrence, new ulcerations, amputation or re-amputation).   "
91613|NCT02086942|"     This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to     August 2017.Firstly, All patients included will provide written informed consent. Secondly,     they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen     arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment consists of     four 4-week cycles of induction therapy followed by intensive therapy with another five     modified VCD regimens and maintenance treatment with CP regimen. Then, patients will be     followed up for 24 months after chemotherapy. The investigators will record all the     laboratory and clinical investigations to assess response at different points of the study.     We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version     3.0.Response categories were based on the International Myeloma Working Group uniform     response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen     arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.   "
91614|NCT02086929|"     The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine     extended release (venlafaxine XR) after an 8-week treatment period in patients with major     depressive disorder.   "
91615|NCT02086916|"     Acquiring diarrhoea in hospital is a serious problem and most frequently occurs when     susceptible patients receive antibiotics as part of their (often life-saving) care. The     commonest cause is Clostridium difficile - a bacterium that normally lives in up to a third     of us but causes no problems. Rates of infection had been falling with increased awareness     and improved hygiene but they are starting to creep up again. Clostridium difficile can cause     a range of disease from a short-lived mild diarrhoea to severe disease of the bowel with     major effects on the whole body and even death.      This study aims to identify substances in the stool and in the blood to enable doctors to     predict how severe that individual's disease will be. These tests can easily be performed. If     they prove accurate in identifying the subsequent severity of the patient's illness due to     Clostridium difficile, patients predicted to develop the worst disease can receive the most     intensive treatments before they become too unwell to benefit. On the other hand, patients     whose disease is predicted by these markers to run its course without causing serious     consequences can be spared the side effects and risks of more intensive treatment.   "
91616|NCT02086903|"     To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers     compared with standard Clopidogrel agent.   "
91617|NCT02086890|"     Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no     proven treatment. Patients are interested in trying alternative therapies to try to reduce     their vision loss, but only limited research evidence exists to support their use and     potential benefit. The goal of this research project is to gain a better understanding of     possible changes in ocular and retinal blood flow and measures of vision in RP patients     receiving two promising therapies, electroacupuncture and transcorneal electrical     stimulation.   "
91618|NCT02086877|"     As survival rates from critical illness improve, strategies to return patients to their     baseline cognitive and functional status are important research priorities. Up to 100% of ICU     survivors will suffer some degree of cognitive impairment at hospital discharge and     approximately 50% will have decrements that persist for years. While the mechanisms for this     newly acquired brain injury are poorly understood, several risk factors have been identified.     Unfortunately, it is unclear how to accurately predict long-term cognitive impairment.      Immediate opportunities to improve cognitive outcomes through risk reduction exist. The     investigators propose to comprehensively study the prevalence of sleep abnormalities and     their association with cognitive impairment, as it may yield potential targets for effective     therapy. Moreover, the investigators will examine for gene x environment associations [APOE     ε4] that may allow for genetic risk stratification of individuals at greatest risk of     cognitive impairment. The investigators hypothesize that EEG [a sensitive longitudinal marker     of brain dysfunction] is a novel and independent predictor of long-term cognitive impairment,     and possibly a candidate intermediate end point for future clinical trials.      This study has the potential to identify novel biomarkers and risk factors for post-critical     illness cognitive impairment, and may lay the foundation for rational interventions to     mitigate risk in high-risk individuals.   "
91619|NCT02086864|"     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents     during childhood, with at least some symptoms causing impairment before the age of seven. It     is characterized by developmentally inappropriate levels of inattention and/or     hyperactive-impulsive behavior, with significant impairment occurring in at least two     settings. It affects approximately 5.2 million children in the United States. Homeopathic     treatment has been shown to be a promising intervention for ADHD, however the reasons for     that effectiveness is unclear. Specifically, it is unclear whether improvement is due to the     homeopathic medicine, the consultative process, or other non-specific effects.      This study has 3 primary objectives: 1. to determine if there are any specific effects of     homeopathic medicines in the treatment of ADHD, 2. to determine if there any specific effects     the homeopathic consultation alone in the treatment of ADHD, and 3. to determine if there is     an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the     treatment of ADHD.      This is a three arm study. Participants will be randomized to one of three arms:      Arm 1 (Verum group): a treatment arm where the participant will receive homeopathic     consultation plus a homeopathic remedy Arm 2 (Placebo group): a treatment arm where the     participant will receive homeopathic consultation plus a placebo remedy Arm 3 (Usual care     group): participants will continue with usual care and will not receive homeopathic treatment     as part of the study.      Participants enrolled in this study, regardless of which study Arm they are in, may continue     with all conventional medications or any other aspect of their current standard of care they     are taking as recommended by their usual physician (so long as they are on a stable dose of     the conventional ADHD medication for at least 6 weeks prior to beginning the trial). They may     also continue to attend regularly scheduled visits with their own health care     practitioner(s).      Participants may also start, stop or change the dose of any therapy (including conventional     medications) during the study and are asked to report the change to the study team. Thus, the     placebo group participants are not different than other participants, except that they will     have a homeopathic consultation and a placebo remedy. The use of placebo is specific to     homeopathic treatment, to allow for double-blinding, which is recognized to reduce study     bias.      Prior to enrolling in the study, those considering participation will undergo a full     assessment by a psychiatrist with a specialty in child and youth mental health. This     assessment confirms the diagnosis and screens for inclusion/exclusion study criteria. At the     same time, the psychiatrist recommends evidence-based therapies to clients including     conventional medication. The psychiatrist does not directly treat the client. If medication     is recommended and the clients wish to pursue it with their regular physician, they would     still be able to enroll in the study if they wanted to, after six weeks of reaching a stable     dose.      This study will help our understanding of the treatment process and whether different     elements of the intervention have greater or lesser effects.      This study is a follow-up to an open label pilot study of the homeopathic treatment of ADHD     using the same study team. Sample size was calculated based on the results of that study.   "
91620|NCT02086851|"     The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle     modification program focusing on dietary modification and exercise. Parents will be     randomized into control and motivational interviewing-based intervention groups. The primary     hypothesis is that adolescents whose parents are in the intervention group will have improved     compliance, weight loss and health outcomes compared with adolescents whose parents do not     receive the intervention.   "
91621|NCT02086838|"     Evaluate the effect of iron supplementation using oral routes in comparison with total dose     infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.   "
91649|NCT02086461|"     Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem.     No treatment is currently available. It can be hypothesized that incomplete relaxation of the     pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may     therefore be a potentially effective treatment.   "
91622|NCT02086825|"     The aim of the current study is to determine whether rifaximin or lactulose is more effective     in preventing the development of severe hepatic encephalopathy in hospitalized patients with     cirrhosis and new onset kidney failure.      Subjects will be randomly assigned to one of two treatment groups:      Group A: Lactulose 20g dose titrated to 2-3 soft-formed bowel movements per day Group B:     Rifaximin 550mg tablet twice daily.      Subjects will be followed daily for two weeks or until hospital discharge. Treatment success     is defined as prevention of grade 3 or 4 HE during hospitalization.   "
91623|NCT02086799|"     This study will explore whether supplementation with thyroid hormones in the set-up of asthma     exacerbation could improve the clinical outcomes.      The study will include adults admitted to Rambam health care campus for moderate to severe     Asthma exacerbation.      The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial.     Patients will be randomized on admission to receive treatment with intra-venous thyroxine     (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study     treatment will be given only after the initial bronchodilator therapy, oxygen and informed     consent are given. The primary endpoint is the time to return of the peak expiratory flow     (PEF) rate to normal values or personal base line.   "
91624|NCT02086786|"     To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting     formulation (in situ microparticle, ISM) of risperidone over four IM injections in the     gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients     with schizophrenia.   "
91625|NCT02086773|"     The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL,     has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.   "
91626|NCT02086760|"     Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and     scintigraphy wich is a binding exam for children. We wanted to evaluate the use of     ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect     which hydronephrosis need a surgery or not.   "
91627|NCT02086747|"     The investigators hypothesized that 1 mg of acetaminophen 4 times per day for 3 days prevent     chronic pain in hysterectomy patients.   "
91686|NCT02085980|"     The purpose of this study is to assess the safety and the efficacy of a laser in the     treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the     vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).   "
98766|NCT01993394|"     The primary aim of this project is to get further knowledge on the effects of + Gz     accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study lung     perfusion and cardiovascular function in these conditions.   "
91628|NCT02086734|"     The purpose of this study is the evaluation of dynamic contrast-enhanced CT (Perfusion-CT)     for therapeutic response predicition in patients with metastasized renal carcinoma (mRCC)     undergoing antiangiogenetic therapy (AAT) with multikinase inhibitors.      In this study patients with mRCC under AAT will be examined with 3 serial Perfusion - CT     scans - partially intergrated in their regular staging CT scheme - at baseline (before AAT     start), 1 week after AAT as well as 8 weeks after AAT initialization. Thereby selected     intrabdomial or intrathoracic metastases will be monitored longitudinally with perfusion CT.     Pretreament and post-treament perfusion characteristics of the assessed metastatic lesions     will be quantified and correlated with patient outcome.   "
91629|NCT02086721|"     The formation of metastasis is responsible for as much as 90% of cancer-associated mortality.     In spite of recent advances in oncologic therapy, approximately 50 % of the lung cancer     patients have already overt disseminated cancer at diagnosis. Additionally, numerous patients     with locoregional disease initially treated with curative intent develop (oligo)metastases     during the course of disease. In both instances, these stage IV patients are generally     considered to be incurable and mostly treated palliatively.      Oligometastases, defined as 1-5 sites of active disease on whole body imaging, was coined to     refer to isolated sites of metastasis resembling limited tumor metastatic capacity. The     implication of this concept is that local cancer treatments are curative in a proportion of     patients with metastases and that incorporating local therapy is a conceptually attractive     approach. In several, but not all, academic centers the standard treatment of patients with     oligometastases in good general health is standard chemotherapy followed by surgery or by     Stereotactic Ablative Body Radiotherapy (SABR) with radical dose on the macroscopic visible     tumors.      The widespread introduction of SABR and of minimally invasive surgery has fuelled research in     treating patients with oligometastases. Indeed, local control of metastases can be obtained     in virtually all parts of the body with a low proportion of patients experiencing severe side     effects. In the few prospective studies published to date, approximately 20% of patients     remained free of recurrence several years after treatment when all sites of disease were     targeted by radiation.      Along with standard anti-cancer therapeutic modalities like chemotherapy and radiotherapy     (RT), immunotherapy has recently gained a lot of attention.      Angiogenesis is one of the hallmarks of cancer, and therefore, considerable efforts have been     made to exploit this unique target for selective drug delivery. One of the appealing targets     for both approaches is the splice variant of fibronectin containing extra domain B (EDB),     which is abundantly expressed in vascular endothelial cells of a variety of primary tumors as     well as metastases , but virtually absent in normal tissues. Recently, a human recombinant     scFv fragment directed against EDB, designated L19, was developed and subsequently combined     with the pro-inflammatory interleukin-2 (IL2), resulting in the immunocytokine L19-IL2.     L19-IL2 delivers high doses of IL2 to the (metastatic) tumor site(s) exploiting the selective     expression of EDB on newly formed blood vessels. Interleukin-2 (IL2) plays an essential role     in the activation phases of both specific and natural immune responses. Even though it has no     direct cytotoxic effects on cancer cells, it can induce tumor regression by stimulating a     potent cell-mediated response. In summary, L19-IL2 is an immunocytokine which will stimulate     immune response specifically in tumors with angiogenesis and tissue remodeling.      Radiotherapy is a particularly interesting partner for immunotherapy, since it can be     harnessed to specifically modify the immunogenicity of the primary tumors and their     microenvironment, in the attempt to generate an in situ immunization of the host against a     patient's own cancer. Our hypothesis is that three independent therapeutic approaches will     synergize to improve dramatically survival in patients with oligometastases of solid tumors.   "
91630|NCT02086708|"     HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate     quantitative measurements that can be used to stage liver fibrosis in pediatric patients with     chronic liver disease.      Specific Aims:      To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect     diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine     clinical care.   "
91631|NCT02086695|"     The early detection of BVZ or Sunitinib mediated cardiotoxicity using cardiac biomarkers and     novel Transthoracic Echocardiogram (TTE) techniques may allow one to adjust treatment and/or     administer prophylactic cardioprotective agents, prior to the development of irreversible     cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will     be able to accurately detect subtle cardiac injury at a time when conventional Left     Ventricular Ejection Fraction (LVEF) remains normal in BVZ or Sunitinib mediated     cardiotoxicity. Additionally, we hypothesize that Endothelial Function Test (EndoPAT) testing     can detect early BVZ or Sunitinib mediated endothelial dysfunction.   "
91632|NCT02086682|"     The introduction of unfractionated heparin (UFH), which prevents clotting of the     extracorporal circuit, was one of the key advances that led to the rapid development and     expansion of hemodialysis services. However, anticoagulation during hemodialysis of the     patient at high risk for bleeding remains a frequently encountered problem in both inpatient     and outpatient dialysis practice.      Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help     reduce heparin use and decrease clotting rates. The goal of this study is to prospectively     examine impact of the Streamline airless blood tubing set, in an inpatient setting, on     dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.   "
91633|NCT02086669|"     Patients with newly diagnosed achalasia have been submitted to either treatment with     pneumatic dilatation or surgical myotomy. Minimal follow up five years.   "
91634|NCT02086656|"     Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline     and/or high risk resectable colorectal cancer liver metastases   "
91635|NCT02086643|"     The goal of this study is to determine the success rate of the retroclavicular approach for     the anesthesia of the upper limb in the obese patient population (BMI ≥ 30 kg/m2)   "
91648|NCT02086474|"     The objective of this study is to assess the changes in daily physical activity and gait     pattern, following a viscosupplement injection among a population who is suffering from hip     osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a     functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36     (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology     affects the quality of life, will be use.   "
93308|NCT02064738|"     The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6     fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal     symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease     (AERD).   "
91636|NCT02086630|"     This study addresses racial/ethnic disparities in HIV/AIDS treatment. Many persons living     with HIV/AIDS (PLHA) in the U.S. (10-19% of PLHA), predominantly African-Americans and     Latinos, delay taking Highly Active Antiretroviral Therapy (HAART) until late in the course     of their HIV disease or never initiate HAART when it is medically indicated. However, there     are no behavioral interventions to increase HAART initiation among PLHA who delay or decline     HAART (PLHA-DD). The overarching aim of the proposed study is to develop a flexible,     targeted, and sustainable behavioral intervention to increase HAART initiation among PLHA-DD,     which, if efficacious, will lead to reductions in morbidity, early mortality, and health care     costs, as well as increased viral load suppression (reducing transmission to others).     Further, the study complements and primes participants for existing adherence interventions,     from which PLHA-DD can benefit when they initiate HAART.   "
91637|NCT02086617|"     The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA)     among male patients with coronary artery disease (CAD). Secondary purpose is to document     cost-effectiveness of ultrasound screening of AAA in selected population.      Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the     basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems     to be higher in CAD population than unselected male population. This leads to hypothesis that     selective screening of these patients (for AAA) could be cost-efficient and life saving     option for detecting AAAs before rupture.      Study will be carried out as a single-center prospective screening study. Patients will be     selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient     information system. Inclusion criteria will be any kind of atherosclerotic heart disease     (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or     treated AAA and failure to give informed consent.      800 patient records that meet the inclusion criteria will be reviewed for eligibility.     Invitations for screening will be sent for 600 patients with intention to have at least 400     patients screened. Screening will be done by verified sonographers in designated screening     appointments.   "
91638|NCT02086604|"     This Phase I clinical trial studies the side effects and maximum tolerated dose (MTD) of the     combination of brentuximab vedotin (BV) and lenalidomide in the treatment of patients with     relapsed or refractory diffuse large B-cell lymphoma (DLBCL).   "
91639|NCT02086591|"     The purpose of this study is to determine whether doxycycline is effective in the treatment     of relapsed Non Hodgkin Lymphomas (NHL).   "
91640|NCT02086578|"     The purpose of this study is to determine if a radiation treatment called Multi-beam     Intensity Modulated Radiation Therapy(IMRT) can reduce side effects related to your implant     if they are a candidate for radiation therapy. Currently, the standard method of giving     radiation is with 3D radiation, which only uses 2-5 beams of radiation. Multi-beam IMRT     works by using 8-12 small radiation beams to give a more tailored or customized radiation     dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT     may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is     to reduce complications after irradiation to the implants.      The study doctors have recently completed a trial using this technique and are now     specifically looking at its impact on women with implant reconstructions who are undergoing     post-mastectomy radiation therapy. By delivering a more customized dose of radiation to the     implant, the intent is to reduce side effects of radiation on the implant.   "
91641|NCT02086565|"     Background: Asthma morbidity is high in inner-city minority adults, despite the existence of     efficacious therapy. Tailored, patient-centered interventions are needed to improve access to     care and patient-provider communication. Access and communication increasingly rely on     information technology (IT) as new incentives arise to use the Electronic Health Record     (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and     practices. How the poor and those with limited educational opportunities can take advantage     of these is unclear. In contrast, the investigators have found that home visits (HVs) by     community health workers (CHWs) can improve access to care for children and promote     caretaker-clinician communication. The investigators also found many inner-city adults have     internet access and are willing to learn to use the PP.      Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs     who will encourage/facilitate PP use, understand patients' social context, and enhance     communication with the medical team. The investigator hypothesize all patients will benefit     from PPs, and that the addition of HVs will be particularly helpful for those with low     literacy or language barriers. Specific Aims test if the 1-year interventions result in 1)     better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more     communication (use of PP) and access (appointments made and kept) which mediate the     interventions' effects on asthma outcomes, and 4) effect modification by literacy level,     primary language, and convenience of internet access.      Methods: In a randomized controlled trial, 300 adults, predominantly African American and     Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will     be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs     will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a     view of the complex social circumstances of patients' lives to providers, and 4) make up for     differences in patients' health literacy skills.      Patient Outcomes are asthma control, asthma-related quality of life, emergency department     (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health     conditions affect patients' ability to perform their daily tasks and care for their families.     Potential benefits of the intervention are enhanced patient-clinician communication, access     to care, improved health, and ability to use IT.   "
91642|NCT02086552|"     This phase II trial studies how well sonidegib and lenalidomide after stem cell transplant     works in treating patients with multiple myeloma. Sonidegib and lenalidomide may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth and may delay     multiple myeloma from coming back after a stem cell transplant.   "
91643|NCT02086539|"     This study aims to determine the effectiveness of 4 different recruitment techniques for     enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for     the study will be randomized into one of 4 groups and will all receive the same recruitment     letter inviting them to participate in the study by enrolling on an online platform. Group 1     will receive the recruitment letter in a normal sized envelope, Group 2 will receive the     recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter     shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image     of an Amazon gift card and told they will receive a $25 gift card if they enroll in the     study. All other groups are told that they will receive a $25 check upon enrollment in the     study.   "
91644|NCT02086526|"     The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can     be separated into subtypes based on their response to metformin. The investigators propose     here to use both targeted and non-targeted metabolomic approach to identify pathways     associated with metformin's effect on insulin sensitivity and endothelial function. This     pilot project will be the foundation for developing tailored therapeutic approaches to     Polycystic Ovary Syndrome and identifying novel drug targets.   "
91650|NCT02086448|"     The purpose of this study is to better understand how sleep apnea, a common sleep disorder in     which a person has one or more pauses in breathing or shallow breaths while sleeping, may     affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP), a     treatment that uses mild air pressure to keep the airways open during sleep, for pregnant     women with sleep apnea.   "
91651|NCT02086435|"     The aim of this study protocol will be to compare the technique of intracorporeal     morcellation using reusable electronic device (standard technique) with a technique of     removal protected by endobag and extracorporeal myoma morcellation with cold scissors and     scalpel blade or with power morcellator used inside the bag itself.   "
91652|NCT02086422|"     Patients with CHF benefit from heart rate lowering, and the investigators have previously     demonstrated that this does not adversely affect exercise tolerance. In a pacemaker     population we also have shown that preventing heart rate lowering is detrimental in terms of     symptoms and prognosis.      The aim of the study is to therefore to establish whether heart rate limitation in patients     with heart failure has a negative impact on exercise capacity. If the investigators establish     that this is not the case, physicians will be able to confidently prescribe heart rate     lowering agents, and programme pacemakers to allow bradycardia without the concern that there     will be detrimental effects of symptom.   "
91653|NCT02086409|"     Gait and posture disorders are very common in subjects aged 65 and over, and result mainly     from neuromuscular and cognitive disorders.      Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and     over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive     performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the     intake of vitamin D combined or not with calcium may improve muscle strength and cognitive     performance.      The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of     vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and     executive performance, 2) and that this improvement depends of the initial level of vitamin D     deficiency.   "
91655|NCT02086383|"     The purpose of this study is to investigate whether pulmonary rehabilitation (PR) is     effective in increasing level of (a) physical activity (PA) and (b) self-efficacy in patients     with chronic obstructive pulmonary disease (COPD).      PR is an evidence-based multidisciplinary approach consisting primarily of a supervised     exercise program with educational components. It has demonstrated high efficacy in improving     dyspnoea, health-related quality of life (HRQoL) and functional exercise capacity in patients     with COPD. Despite these improvements, there is no conclusive evidence that these benefits     translate to an increase in PA in patient's day-to-day life. This is of concern as low PA is     a predictor of all cause mortality, correlated with lower HRQoL, increased level of dyspnoea     and higher number of hospital admissions in this group of patients.      Self-efficacy is found to be an instigating force in forming intention to exercise and in     maintaining practice for an extended time. Self-efficacy may be the key in determining     whether a patient translates the improvement in exercise tolerance to actually being more     physically active. Based on current knowledge, there is insufficient evidence that     self-efficacy increases after pulmonary rehabilitation and no correlation has been made     between level of self-efficacy and level of PA in these group of patients.      Hence this study aims to find out whether the existing PR program increases level of PA and     self-efficacy. Correlation between level of PA and self-efficacy will be made.   "
91656|NCT02086370|"     The aim of this RCT of study is to compare the outcomes of the standard salpingectomy     (removal of the fallopian tube) with the radical removal of the tube and the mesosalpinx in     terms of ovarian reserve.   "
91657|NCT02086357|"     Ultrasound (US)tissue elastography has recently been found to have a number of clinical     applications in the assessment of soft tissue disease for example, in breast and thyroid     pathology. There are few current studies exploring its use in musculoskeletal pathology,     particularly a new technique called sheer wave ultrasound elastography (SWUE).      Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics,     sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical     effectiveness in these areas.      Our aim is to explore the effectiveness of this technique in the assessment of     musculoskeletal pathology.      Participants will be recruited through current referral protocols and would undergo an     additional elastographic investigation in addition to their standard US examination. This     investigation will be conducted within the musculoskeletal US department at Chapel Allerton     Hospital by trained musculoskeletal specialists. The study will be conducted over a period of     approximately 24 months with quarterly review during this time.   "
91658|NCT02086344|"     The aim of this RCT of study is to compare the standard TLH with adnexal preservation with     TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical     outcomes   "
91659|NCT02086331|"     This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the     blood supply to the muscles of the leg, and how this changes with exercise and vascular     pathology.   "
91660|NCT02086318|"     To collect data of clinical, biochemical and 3D-ultrasonographic parameters of a population     of fertile women aged 18-55 in order to design a new algorithm able to predict ovarian age     and to evaluate the reliability of a multimodal diagnostic evaluation of ovarian age in term     of both reproductive prognosis and distance to menopause following the guidelines of the     Standards for Reporting of Diagnostic Accuracy initiative (STARD)   "
91669|NCT02086201|"     This is a non-inferiority trial of Engage, a new intervention for late-life depression, and     problem solving therapy (PST). Patient participants will be randomized to either Engage or     PST and receive 9 weeks of either intervention. Interview assessments will be collected at     baseline and weeks 2, 4, 6, 8, 9, 26, and 36. Clinician participants, social workers from     mental health agencies, will be randomized to receive training and certification in either     Engage or PST.   "
91670|NCT02086188|"     The purpose of this study is to determine if treatment with Mirabegron will improve urinary     urgency control beyond that achieved with pelvic floor exercises alone   "
91671|NCT02086175|"     This research study is evaluating a drug combination called Imprime PGG and Rituximab as a     possible treatment for relapsed/refractory indolent B cell non-Hodgkin lymphomas (NHL).   "
91661|NCT02086305|"     Palliative care for end-stage organ failure patients has been included as one of the key     programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the     disease groups, end-stage heart failure patients have the highest mortality rate. Patients at     the end stage of heart failure have health concerns shared by other end-stage patients     including cancer patients. Many guidelines, local and world-wide, have advocated a palliative     approach of care for those heart failure patients who are at end stage. Studies have shown     that end-stage heart failure patients tend to have frequent emergency room visits and     repeated hospital admissions. Also, these patients suffer from a number of health problems     that adversely affect their Quality Of Life.      There is scarcity of experimental studies informing practitioners which models work best for     palliative patients in Hong Kong. There were randomized controlled trials conducted outside     Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce     readmissions but evidence is not present for other outcomes such as symptom control and carer     burden.      In an attempt to fill knowledge gap and inform practice using evidence, this study is     launched to compare the effects of a customary hospital-based palliative heart failure care     and an interventional Home-based Palliative heart failure Program.      Hypothesis        -  there is no difference in health care utilization for end-stage heart failure patients          between the customary hospital-based group and the Home based palliative heart failure          program group        -  there is no difference in evaluated health outcomes (functional status, symptom          intensity, and satisfaction with care) between the customary hospital-based group and          the Home based palliative heart failure program group        -  there is no difference in perceived health outcomes (quality of life, caregiver burden)          between the customary hospital-based group and the Home based palliative heart failure          program group        -  there is no difference in cost effectiveness between the customary hospital-based group          and the Home based palliative heart failure program group        -  there is no difference In patients' lived experiences between the customary          hospital-based group and the Home based palliative heart failure program group   "
91662|NCT02086292|"     The aim of the study is to find a simple method for pain reduction that can be used in     clinical practice when administering digital nerve block with a single subcutaneous     injection. It will be investigated whether a smaller volume of lidocaine can decrease pain     during injection.   "
91663|NCT02086279|"     To evaluate the variation of AMH levels in women undergoing treatment with GnRHa, and to     assess whether this variation correlates with changes in the antral and pre-antral follicle     ultrasonographic count (AFC).   "
91664|NCT02086266|"     The purpose of this study is to compare the efficacy between a Pilates exercise program and a     Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES)     in the recovery of urinary continence (UI) after radical prostatectomy.      There are no studies that evaluate Pilates mat exercises for incontinence in men although it     can be assured that this method has the pelvic floor contractions as a principle for     practice. If this new therapeutic approach proves to be as effective as described treatment     in improving urinary complaints, it will be an option for patients who prefer a non-invasive     treatment.   "
91682|NCT02086032|"     Investigators have found that sleeping disorder is an important problem in menopausal women.      There have been papers reporting the effect of hormonal therapy on sleeping, but fews have     reported the effect of different progestogens on sleeping quality. There is a need for more     in-depth study and more conclusive evidence about the progestins which have the most     beneficial effects on sleeping disorders in menopausal women.      This study is going to collect the data from newly identified menopausal patients who are     eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The     affects of the therapy will be monitored for 3 months.   "
91683|NCT02086019|"     For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an     invasive-guided strategy will prove superior to a conservative strategy with respect to a     combined endpoint of all cause mortality and non-fatal myocardial infarction.   "
91665|NCT02086253|"     Endothelial dysfunction of conduit arteries contributes to the increased morbidity and     cardiovascular mortality in patients with essential hypertension and appears increasingly as     an independent therapeutic target. We have shown previously that besides a decrease in the     availability of NO and other endothelium-derived vasodilators factors, the     epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a     role in the pathophysiology of this endothelial dysfunction. Indeed, the local concentrations     of endothelin-1 during the endothelium-dependent dilation of the radial artery in response to     a sustained increase in blood flow decreased significantly in healthy volunteers controls but     not in hypertensive patients. This lack of adaptation of the endothelinergic system could be     due to a decreased clearance of endothelin-1 by endothelial ETB receptors, potentiating the     vasoconstrictor action of endothelin-1 mediated by ETA receptor activation at the muscular     level. However, to validate this hypothesis , it is needed to demonstrate the physiological     role of ETA receptor and ETB in sustained flow-mediated dilatation of conduit arteries.   "
91666|NCT02086240|"     The Translocator Protein (TSPO) is a protein which reaches very high levels when there is     inflammation in the brain.      Recently, radioligands have been developed which attach to the TSPO (a radioligand is a drug     which has been tagged with radioactivity). Using positron emission tomography (PET) imaging,     the radioligand can be detected following injection into a patient. However, it is difficult     to accurately measure the amount of TSPO using PET at the moment. This is because the brain     does not have a reference region for TSPO (ie an area in the brain with no TSPO at all).     Reference regions are very useful to help work out how much of a PET signal represents     specific binding (of the radioligand to the target of interest), and how much represents     non specific binding (of the radioligand to many other structures which are not of     interest). In the absence of a reference region, non specific binding can be estimated by     giving a drug which binds to the TSPO.      The drug prevents the radioligand binding the TSPO and (in a manner of speaking) creates a     temporary reference region so non specific binding can be measured. To do this, we will use     XBD173 (Emapunil is an anxiolytic drug which acts as a selective agonist at the peripheral     benzodiazepine receptor) to bind TSPO and block binding of the PET ligand ([11C]PBR28), a     TSPO ligand from the phenoxyarlyacetamide class.      Most TSPO PET studies (and in one of our previous studies approved by West London REC)     quantify the signal using a ratio of specific binding in the brain to radioactivity in the     blood. This requires arterial line insertion which is burdensome for subjects, and increases     variability. In this study we aim to determine the ratio of specific binding in the brain to     nonspecific binding in the brain by using the temporary reference region. For more accuracy     the participants will repeat the scanning procedure so determine test-retest variability of     the amount of TSPO.   "
91667|NCT02086227|"     The primary objective of this study is to ascertain the pharmacokinetics (PK) and     pharmacodynamics (PD) bioequivalence of a subcutaneous (SC) injection of 1 mg (1 IU) of     Glucagon (Fresenius Kabi USA) in comparison to the reference product, GlucaGen® (Bedford     Laboratories), 1 mg (1 IU), SC in healthy adult subjects.   "
91668|NCT02086214|"     The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive     pressure therapy on Assisting Hand Assessment (AHA) performance in Cerebral Palsy (CP). To     perform this study, 80 CP patients aged of 5 to 10 years old will be included in a     multicentric, double blind, prospective parallel-group randomized study. Treatment will be a     pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary     outcome is to increase of 60% of AHA performance. The secondary outcome are to increase     Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory     Evoked Potentials (SEP).   "
91704|NCT02085746|"     This will be a descriptive study using patients from the Urogynecology and Urology University     of South Florida Clinics and Urology clinic at Tampa General Hospital Healthpark on 30th     Street to analyze the impact of demographics on the definition of being sexually active. It     is believed one's demographics influence their definition of being sexually active.   "
91672|NCT02086162|"     Up to 80% of people with schizophrenia and schizoaffective disorders smoke - a rate that is     four times the rate in the general population. Cessation treatments are effective, but these     smokers don't use them. In order to provide an easy-to-use, cost-effective strategy to engage     this group of smokers into effective treatments, we developed a single-session, web-based,     motivational decision support system, Let's Talk About Smoking. The system incorporates     features that insure high usability among those who can't use current websites due to     cognitive impairments and low computer skills. It provides compelling content that engages     users into evidence-based cessation treatments.      In this study we will definitively test the decision support system in a randomized     controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders.     Our proposed study design will enable us to test whether this system, designed for those with     cognitive impairments, is effective among people with a range of cognitive abilities. The     Specific Aims of the study are:        1. To determine whether use of the web-based decision support system leads to higher rates          of initiation of smoking cessation treatment than use of a computerized educational          pamphlet. We will also assess effectiveness on secondary outcomes, including smoking          behavior, urges and outcome expectancies; level of dependence; intentions to quit and to          use cessation treatment; and abstinence.        2. To assess whether cognitive ability moderates initiation of smoking cessation treatment.          Since cognitive impairment impedes use of standard web-based interventions by this          group, and cognitive impairments likely supersede other potential moderators (education          and socioeconomic status), this aim will be key to determining the success of our          intervention and will guide further revisions if they are needed.        3. To explore the effects of the decision support system and baseline cognitive ability on          abstinence over 6 months             1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence               at 6 months, and cumulative days of tobacco abstinence over 6 months.             2. We will determine whether baseline cognition (scale scores) is associated with               7-day point prevalence tobacco abstinence at 6 months, and cumulative days of               tobacco abstinence over 6 months.   "
91673|NCT02086149|"     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise     intervention for helping individuals with elevated depressive symptoms to quit smoking. The     investigators expect that this project will contribute much needed knowledge about the role     that aerobic exercise can play in smoking cessation. The long-term goal of this program of     research is to disseminate an effective, aerobic exercise (AE) intervention for smoking     cessation that can be readily adopted by smokers with elevated depressive symptoms, including     those with current major depressive disorder (MDD).   "
91684|NCT02086006|"     This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with     single de novo, Type A lesions < 10 mm in length and located in a native coronary artery with     a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All     patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of     Myolimus.        -  Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at          baseline and at 6 months.        -  Optical Coherence Tomography (OCT) will will be completed for all patients at baseline          and at 6 months.        -  Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12          and 24 months.   "
91674|NCT02086136|"     Acute aortic dissection (AD) is a deadly, difficult to diagnose disease presenting with an     array of common and unspecific symptoms. Aortic dissection detection (ADD) risk score as a     bedside clinical tool to estimate the risk of AD. D-dimer has been evaluated in several     studies as a biomarker of AD, and has showed a pooled diagnostic sensitivity of 97%. However,     considering the severe morbidity and mortality of AD, a negative D-dimer per se is considered     insufficient to rule-out AD in unselected patients.      The aim of the present study is to evaluate whether the diagnostic performance of D-dimer     differs in patients at different clinical risk of AD, and in particular whether a negative     D-dimer test may allow safe rule-out of AD in any patient subgroup without necessity to     perform urgent aortic imaging.      Consecutive adult patients with suspected AD presenting to ED will be enrolled before the     establishment of a final diagnosis; a standardized clinical form comprehensive of     presence/absence of 12 risk markers allowing ADD risk score fulfilled and d-dimer levels     measured at presentation.      The aortic imaging exam used to confirm or refuse of AD will be computed tomography     angiography or transesophageal echocardiography and final diagnosis established after     reviewing of all available data.      The accuracy, failure rate and efficiency of a diagnostic strategy combining standardized     clinical stratification via the ADD risk score with D-dimer testing will therefore be     assessed.   "
91675|NCT02086123|"     Laparoscopic colorectal surgery (LCS) has gained wide acceptance in the treatment of various     pathology from diverticular disease to colon cancer. In comparison to conventional open     surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower     wound-related complication rates, better cosmetic results and earlier return to normal     activities.      Despite the fact that laparoscopic colorectal surgery is done through smaller incisions,     there is still a considerable amount of abdominal wall trauma with these procedures. This     still can cause a significant amount of postoperative discomfort, which can add to patients'     stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can     be difficult to control and has been mainly managed pharmacologically with the use of     narcotics and non-narcotic medications delivered through different routes. The effectiveness     of pain control depends on the medication, its dosage, frequency and route of administration.     The latter is mainly achieved through the intravenous route in the immediate postoperative     period in laparoscopic colorectal surgery patient, as patients are restricted from having     anything by mouth until return of bowel function.      Another route of delivery is the use of local anesthetics as well as opioids via an epidural     catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and     decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia in     obstetrics, to date there has been very few studies looking at the effectiveness of epidural     analgesia in laparoscopic colorectal surgery.      The primary purpose of this study is to evaluate the impact of epidural analgesia as compared     to conventional analgesia on the length of hospital stay in patients undergoing laparoscopic     colorectal procedures. The secondary objectives of the study will be to evaluate patient     satisfaction, quality of life, pain control and return of bowel function in patients treated     with either epidural analgesia or intravenous narcotics.   "
91676|NCT02086110|"     The purpose of this study is to determine the tolerability of dietary supplements and if     these supplements can promote a healthy bacterial environment in the intestines of children     with autism spectrum disorders and gastrointestinal complaints.   "
91677|NCT02086097|"     The purpose of this study is to investigate the analgesic efficacy of multiple doses of     Dexketoprofen Trometamol 25 mg on postoperative pain following emergency endodontic treatment     in teeth with irreversible pulpitis, using as control Ibuprofen 600 mg and a placebo group.      Hypothesis:      Dexketoprofen trometamol when administered in multiple doses produces a greater effect to     control postoperative pain after treating symptomatic irreversible pulpitis; in patients     undergoing pulpotomy as an emergency procedure   "
91703|NCT02085759|"     Cytokines are chemicals that are naturally made by your body. Certain cytokine levels are     changed in the blood of patients who develop allergies and/or asthma. Cytokine levels may     also be changed in some individuals who are overweight or obese. The purpose of this study is     to determine if certain cytokine levels differ based on a person's weight and whether or not     they have allergies or asthma. Information gathered in this study will be compared to     information gathered from subjects who have participated in another similar study for     patients who have allergies and/or asthma.   "
91743|NCT02085239|"     This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in     providing an extended period of pain relief for patients undergoing ultrasound guided core     biopsy of the breast.   "
91678|NCT02086084|"     Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases and     is responsible for a significant number of acute hospital admissions. COPD is characterised     by progressive destruction in the elastic tissue within the lung, causing respiratory     failure. The clinical course of COPD is characterised by recurrent acute exacerbations     (AECOPD), causing considerable morbidity and mortality. Patients with moderate to severe     acute exacerbations present with increased work of breathing and hypercapnia. The standard     for respiratory support in this setting is non-invasive ventilation (NIV), a management     strategy underpinned by a considerable evidence base. However despite NIV, up to 30% of     patients with AECOPD will 'fail' and require intubation and mechanical ventilation. The     mortality rate for patients requiring NIV is approximately 4%, if conversion to mechanical     ventilation occurs the mortality is 29%.      The last decade has seen an increasing interest in the provision of extracorporeal support     for respiratory failure. The key element that has underpinned improving survival has been     technological advancement. This has resulted in pumps causing less blood trauma and     inflammatory response, better percutaneous cannulation techniques and coated circuits with     reduced heparin requirements. Overall this has significantly reduced the complications     associated with the provision of extracorporeal support. One variation of this technique     (extra-corporeal CO2 removal ECCO2R) allows CO2 clearance from the blood. This approach has     been the subject of a number of animal experiments and uncontrolled human case series     demonstrating improved arterial CO2 and reduced work of breathing. Our own unpublished series     demonstrates the same physiological changes. However to date the benefits of this approach     have not been tested in a randomised controlled trial.      The hypothesis is that the addition of ECCO2R to NIV will shorten the duration of NIV and     reduce likelihood of intubation.   "
91679|NCT02086071|"     Feasibility of new biological and histological samples at progression in patients with     advanced or metastatic Non Small Cell Lung Cancer (NSCLC).      A recent paper from Pr Sequist and coll. has depicted the resistance mechanisms as     Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies     showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3     patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine     Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of     the disease. This study will be conducted by the Groupe Français de Pneumo Cancérologie     (GFPC) up to 100 patients during 18 Months. Each center will have to define if re-biopsies     are possible or not and explain why not.   "
91680|NCT02086058|"     The aim of this study (the hypothesis) is to identify differences in the gene expression     profile in the bladder muscle and hereby gain greater knowledge about the muscular mechanisms     that cause overactive bladder and daytime urinary incontinence in children older than 5     years. A secondary aim is to examine how this gene expression profile differs from children     with a neurogenic overactive bladder and how the gene expression profile changes from     childhood till adulthood. Such new knowledge will result in a more precisely targeted and     hence effective treatment of overactive bladder.      The results will be obtained by retrieving bladder biopsies from children and adults     suffering from an overactive bladder or a neurogenic bladder. These biopsies will undergo     molecular analysis and the investigators will compare them with biopises from bladder healthy     adults and children.   "
91681|NCT02086045|"     To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting     Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native     coronary artery lesion designated the target lesion and up to one non-target lesion located     in a separate epicardial vessel.   "
91697|NCT02085837|"     Improve health and outcome for people with late stage chronic kidney disease by providing     patient centered nursing services in addition to a Nephrologist's routine patient care.   "
91687|NCT02085967|"     This study will be a single center, open-label, drug-drug interaction study in healthy male     and female subjects. The study will consist of 2 parts. In Part A, the effects of     steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the     pharmacokinetics of E2006 and metabolites will be assessed. Approximately 30 subjects will be     sequentially assigned to 1 of 2 treatment groups to receive itraconazole or rifampin in equal     numbers (approximately 15 subjects per group). The itraconazole treatment group will be fully     enrolled before enrollment is initiated for the rifampin treatment group. In Part B, the     effects of steady-state dosing of E2006 on the pharmacokinetics of midazolam, a substrate of     CYP3A, plus bupropion, a substrate of CYP2B6, will be assessed in approximately 24 subjects.     The 2 study parts can be conducted in parallel.   "
91688|NCT02085954|"     Stroke patients in the investigators rehabilitation unit follow gait trainings with     robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with     3D gait analysis. The objective of this study is to assess the effects of gait training in     Lokomat on biomecanic gait parameters in stroke patients.   "
91689|NCT02085941|"     This research study is evaluating a procedure called cryoablation (the removal of diseased     tissue using extreme freezing temperatures) as a possible treatment for head, neck and spine     tumors.   "
91690|NCT02085928|"     Lateral epicondylitis (LE) is the most common cause of lateral elbow pain. Intratissue     percutaneous electrolysis (EPI technique) is a novel minimally invasive approach which     consists in the application of a galvanic current through a puncture needle which produces a     local inflammatory process in the soft tissue and the reparation of the affected tissue.      The purpose of this study is to evaluate the clinical and ultrasonographic effectiveness of a     multimodal program using the intratissue percutaneous electrolysis technique and exercises in     the short term for patients with chronic lateral epicondylitis, and to determine whether the     clinical outcomes achieved decline over time.      This study is an observational one-way repeated measures design. 36 patients in a clinical     setting presenting with lateral epicondylitis (mean age = 38, mean time since injury = 12.6     months) received one session of EPI per week over 4-6 weeks, associated with a home program     of eccentric exercise and stretching. The main outcome measures were severity of pain (VAS,     digital algometer, Cozen and Thompson tests), disability (DASH questionnaire), structural     tendon changes (ultrasound), hypervascularity (power doppler) and patient's perceptions of     overall outcome (4-point scale). Measurements at 6, 26 and 52 weeks follow-up included     recurrence rates (increase of severity of pain or disability compared to discharge), the     perception of overall outcome and success rates. Paired Student t-tests and Chi squared tests     were applied to data. Enrollment into this study ended in September 2012.      All outcome measures registered significant improvements between pre-intervention and     discharge. Most patients (30, i.e. 83.3%) rated overall outcome as 'successful' at 6 weeks.     The ultrasonographic finding revealed that the hypoechoic regions and hypervascularity of the     extensor carpi radialis brevis change significantly. At 26 and 52 weeks, all participants     (32) perceived a 'successful' outcome. Recurrence rates were null after discharge, and at the     6, 26 and 52 week follow-ups.   "
91691|NCT02085915|"     The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic     patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an     essential stake to improve the forecast.      Investigators would so like to estimate the interest of the strip PeriScreen for the fast     diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients,     what would allow to make out a will at least on ascites 2000 on about twenty centers for     duration estimated of 12 months.   "
91692|NCT02085902|"     Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy     can be performed as outpatient surgery. This approach is difficult in many centers because of     post operative pain and nausea/vomiting.      The use of postoperative morphine may be responsible for the state of nausea. The use of     ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to     have their surgery as an outpatient.      Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was     used for the infiltration holes trocar. In recent years, ropivacaine is used for the     reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia     ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the     many publications made on this subject. Its use in the investigators daily surgery, however,     has not been evaluated in ambulatory surgery.   "
91693|NCT02085889|"     Background: The association of fructose and lactose intolerance and malabsorption with the     symptoms of different functional gastrointestinal disorders (FGID) is unclear. The mechanisms     behind the multi-organ symptoms remain unclear. Both FGID and saccharide intolerances are     common (>10% of any given population). Dietary modification based on intolerance diagnostics     could provide an effective treatment for FGID, which are otherwise difficult to treat.      Aim: To investigate the prevalence and interrelationships of fructose and lactose intolerance     (symptom induction) and malabsorption (breath test gas production) and their association with     clinical GI as well as non-GI symptoms in FGID and the outcome of standard dietary     intervention. Mechanisms related to symptom genesis will be investigated using metabolomic     analysis of plasma and urine by gas chromatography/time-of-flight mass spectrometry     (GC/TOFMS).      Methods: Fructose and lactose intolerance (defined by positive symptom index) and     malabsorption (defined by increased hydrogen/methane) will be determined in successive male     and female FGID patients in a single center using breath-testing. Symptoms will be recorded     using standardised questionnaires and the Rome III criteria. The prevalence of the     intolerances in the different FGID subgroups and the associations between breath testing     results, clinical symptoms and the outcome of dietary modification will be assessed. Factors     predictive of the outcome of dietary modulation will be screened for. GC/TOFMS will be used     to assess the human and microbial metabolome in urine and plasma.   "
91694|NCT02085876|"     This is a single centre prospective open-label, non-randomised pilot study whose aim is to     identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the     near future, to avoid the need for liver biopsy.      To achieve this:        -  The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho          T2*. The other data will be extracted from usual sequences.        -  Part of the histological samples will be used for the weighted levels of fat and iron,          and for the lipidomic study.        -  Usual blood samples will be completed by samples for the serum library   "
91695|NCT02085863|"     This is a single center, randomized, double blind, placebo controlled, 2-way crossover     drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of     ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive     combination.   "
91696|NCT02085850|"     Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be     non-glaucomatous in the Tema Eye Survey.      Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed     with glaucoma in the Tema Eye Survey.   "
91699|NCT02085811|"     The aim of this retrospective study is to show that kyphoplasty is a reliable technique in     the treatment of certain traumatic vertebral fractures.      Patients will be selected from medical records archived at the Neuroradiology Department of     Dijon CHU.      An information sheet and questionnaire will be sent to patients together with a letter to ask     them to have a radiographic examination.      The radiographic images will be interpreted by two independent experts to evaluate the angle     pf vertebral kyphosis.   "
91700|NCT02085798|"     Post-authorisation observational study to assess the evolution in normal clinical practice of     patients recently diagnosed with myelodysplastic syndrome (MDS) or chronic myelomonocytic     leukaemia (CMML), depending on the moment when active treatment is initiated. Subjects will     be recruited from approximately 50 haematology sites in Spain.   "
91701|NCT02085785|"     The purpose of this study is to pilot test a program to help overweight and obese individuals     with a lower extremity amputation (LEA) lose weight and become more physically active. The     investigators will randomize approximately 30 individuals to either a self-directed weight     loss program (n=15) or a coached weight loss program (n=15). The primary purpose of this     pilot study is to determine if a home-based weight loss/physical activity (PA) intervention     is feasible in individuals with a LEA. MOVE-LEAP is a 20-week program that involves 11 phone     calls from a health coach and a single home visit by a physical therapist.      This pilot study aims to:        1. test the feasibility of recruiting overweight/obese individuals with LEA into a          randomized trial;        2. assess whether the intervention can be delivered with high fidelity, and        3. evaluate whether the intervention is acceptable to and safe as determined by participant          feedback, participation and retention for outcome measures.   "
91702|NCT02085772|"     This is a single-centre observational, prospective study carried out at the maternity unit of     Dijon CHU. It will include pregnant women with a pre-conception BMI ≥ 30 kg/m² and will     evaluate in these patients, the activation and migration capacities of circulating leukocytes     and their association with the onset of spontaneous labour.      Patients who meet the inclusion criteria will be informed about the study during their     consultation at the 7th or 8th month, and their gynecologist will invite them to take part.     If the answer is positive, the patients will be seen again at a specific consultation for the     study between the 37th and 38the Weeks of amenorrhea at the maternity unit of Dijon CHU.     During this consultation, the gynecologist will conduct a medical examination, while the     Plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes and     1 x 7ml tube).      If labour has not started by 41 Weeks of amenorrhea, the patients will be seen at another     consultation (consultation programmed in the usual follow-up of pregnancy) and a second blood     sample (1 x 6ml tube and 1 x 7ml) will be taken.      The patients will be followed until childbirth and will be split into two groups according to     whether or not they gave birth after the onset of spontaneous labour.   "
91705|NCT02085733|"     Background:      Children presenting with non-traumatic joint pain require different treatment depending on     the cause of pain. Septic arthritis, which results from a bacterial infection in the joint,     often requires a surgical procedure as well as a long course of antibiotics. In contrast,     non-septic arthritis is typically treated by management of symptoms and observation. Current     diagnostic standards involve microbiologic examination of fluid taken from the affected     joint. This procedure can require the patient to be sedated, and the fluid culture analysis     can take up to 72 hours. A single laboratory measure that could be easily obtained and     quickly analyzed would aid in faster diagnosis, fewer diagnostic tests and lower cost of the     diagnostic work-up for this condition.      Recent research on septic arthritis has identified procalcitonin as a potential septic     arthritis diagnostic indicator. Procalcitonin (PCT) is secreted by cells in the thyroid at     higher levels when the body is facing infection. Procalcitonin levels rise slowly over the     first two hours and peak at 24 hours. Levels rise 100-fold in the peripheral blood stream     during this time frame. Several studies have indicated PCT is promising potential diagnostic     indicator for septic arthritis. Unfortunately, many of these studies have relatively small     sample sizes and very few involve pediatric populations. Additional study of PCT and septic     arthritis in children will help evaluate the viability of PCT as a diagnostic indicator.      Research Question:      Can serum procalcitonin assist in clinical differentiation between bacterial (septic) and     non-bacterial arthritis?      Methods:      Patients presenting with possible septic arthritis in the emergency department will be     recruited for this study. Patients who consent to participate will receive the current     standard for care, including IV placement, laboratory tests for Erythrocyte sedimentation     rate (ESR),white blood cell count (WBC), and C-reactive protein (CRP), x-rays and     consultation with pediatric orthopedics. Patients participating in the study will have a     portion of the serum collected for typical diagnostic tests analyzed for PCT. Research     assistants will collect data from medical records of participants, including lab and imaging     results. Patients who do not undergo surgery will be contacted by phone within 7 days of     their ED visit to confirm diagnosis.   "
91706|NCT02085720|"     Objective: Obstructive sleep apnoea syndrome (OSAS) is a common form of sleep-disordered     breathing (SDB) causing sleep fragmentation, daytime sleepiness, cognitive function     impairment, and poor health status in addition to increased risk of cardiovascular     complications. OSAS is equally common among the middle-aged male Caucasian and Hong Kong (HK)     Chinese populations with a prevalence of at least 4%. However, the prevalence of OSAS in the     elderly population in Asia including HK is unknown.      Study Design: A sleep questionnaire will be conducted for 1000 subjects aged at least 60 yrs     in the elderly community centers focusing on symptoms of OSAS, subjective sleepiness,     restless leg syndrome, and sleep-related habits and routines, in addition to past medical     history and medications. Home sleep study (EMBLETTA) capable of recording sleep (a single EEG     channel), respiratory events, snoring, respiratory efforts and oximetry will be performed on     300 subjects randomly. Those who have negative or technical inadequate EMBLETTA study with a     high pre-test probability of moderate to severe OSA will be invited to undergo hospital-based     polysomnography for confirmation of their sleep apnoea status. Subjects with AHI>15/hr     regardless of symptoms or those with AHI 5-15/hr plus comorbid conditions or excessive     daytime sleepiness will be offered continuous positive airway pressure (CPAP) titration     followed by CPAP treatment, with serial assessment of subjective sleepiness, quality of life,     and cognitive function.      Outcome measures: the prevalence rates of SDB (AHI>10, >15 and >30/hr), OSAS, and other sleep     disturbances, such as restless leg syndrome (RLS). In addition, we will examine the factors     which are predictive of the presence of SDB in this population, and assess the CPAP     acceptance, compliance, and treatment outcome of those with OSAS.   "
91707|NCT02085707|"     Patients younger than 70 years with a displaced femoral neck are in serious conditions. The     femoral neck fracture is associated with low activity levels, hip pain and substantially     reduced quality of life. Relatively young individuals with low-energy fractures tend to have     additional morbidity or lower bone quality. The literature indicates that 5 % of all     displaced femoral neck fractures are in patients aged 55 - 70 years. Little research and lack     of consensus and guidance about appropriate treatment of these patients renders choice of     treatment, and the health economic aspect a great challenge. In this study the investigators     aim to answer if patients aged 55 - 70 years with displaced and low-energy femoral neck     fractures treated with a total hip arthroplasty leads to a better functional outcome than     osteosynthesis, and can patient-related factors be identified that predispose for femoral     fracture? It is a randomized multi center study of patients operated with either total hip     arthroplasty or osteosynthesis in which functional outcome, complications and reoperations     are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and     possibly after 3, 5, 10, 15 and 20 years. Map patient - related factors that predispose for     displaced femoral neck fractures for patients aged 55 - 70 years. Map bone density measured     with Dexa for two types of surgical procedures. Map complications and functional outcome     after osteosynthesis or total hip replacement in patients aged 55 - 70 years with displaced     femoral neck fractures.   "
91708|NCT02085694|"     A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by     high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test     whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity     of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.      Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in     the patients undergoing HSCT.   "
91709|NCT02085681|"     The aim of this study is to compare the effectiveness of identifying diabetic retinopathy     using tele-medicine based Digital Retinal Imaging in Diabetes Clinics with that of the     conventional referral system.      Hypothesis: Tele-medicine based digital retinal imaging involving a diabetes centre will     identify proportionately more diabetic patients with DR and lead to higher acceptance rate     with subsequent ophthalmic referral and management   "
91710|NCT02085668|"     The purpose of the trial is to investigate the safety and effectiveness of renal denervation     for the treatment of chronic heart failure (CHF).   "
91711|NCT02085655|"     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's     lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the     efficacy and safety of long-acting aspargase (pegylated aspargase, PEG-ASP) combined with     gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.   "
91712|NCT02085642|"     The purpose of this study is to investigate if acupuncture is more effective than sham     treatment in reducing lower extremity spasticity, and improving gait speed in the chronic     phase of stroke recovery.   "
91713|NCT02085629|"     To collect evidence of the safety of administering donor-derived regulatory macrophage (M     reg) preparations to living-donor renal transplant recipients in the context of an     international European Union funded consortium aimed at evaluating cellular immunotherapy in     solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced     by M reg therapy can eventually be used to reduce the need for conventional immunosuppression     in transplant recipients.   "
91821|NCT02084199|"     This will be an open label study to assess the influence of renal impairment on the     pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of     100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls.      Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects     with renal impairment and matched healthy controls will be evaluated.   "
91714|NCT02085616|"     The purpose of this study was to compare the effectiveness of the high-intensity proactive     service with the low-intensity reactive service at the Swedish National Tobacco Quitline     (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in     reactive service.      The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive     behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to     offer the client a choice of callback (proactive service) or no callback (reactive service).     In the present study clients were not offered a choice, but were randomized to proactive     service on even dates and to reactive service on odd dates. Data are collected through postal     questionnaires, one baseline and one follow-up after 12 months.   "
91715|NCT02085603|"     This study is designed to assess whether a drug called Saracatinib is helpful in controlling     bone pain from cancer. The investigators do not know if it will be, so half of the patients     in the study will receive the drug and half will get placebo. Saracatinib is a drug that has     been tried in patients with many different forms of cancer. It seems to have effects in bone     and so the investigators hope that it will have an effect in those with cancer that has     spread to the bones.   "
91716|NCT02085590|"     In the present study, we want to investigate whether BCG-vaccination enhances the innate     immune response in humans in vivo during (single) human endotoxemia.      In a future experiment we will investigate whether BCG-vaccination can reverse the tolerant     state observed upon a second LPS administration.      Our goal is to ultimately translate our results into clinic applications to reverse for     example sepsis-induced immunoparalysis.   "
91717|NCT02085577|"     Patients with a daily use of opioids may develop higher postoperative pain levels, often need     high doses of morphine and therefore their pain may be difficult to treat. A low dose of an     old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and     morphine consumption in these patients. Our purpose is to investigate the effect of low dose     ketamine on morphine consumption and pain after spine surgery in patients with a daily use of     opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and     side-effects after spine surgery.   "
91727|NCT02085447|"     This is a prospective study using a concierge model of customized adherence enhancement and     long-acting injectable antipsychotic (CAL-Concierge) in 30 individuals with schizophrenia or     schizoaffective disorder at risk for treatment non-adherence and for homelessness. Like the     CAE-L approach, CAL-Concierge is expected to improve health outcomes among the most     vulnerable of populations with schizophrenia but even more importantly, will demonstrate that     it can be used to improve the efficiency and quality of care in typical practice settings.   "
92598|NCT02074059|"     The primary objective of this study is to evaluate the safety and tolerability of aerosolized     surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses     to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous     positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to     neonates receiving nCPAP alone.   "
91718|NCT02085564|"     Background:      The prevalence of gastroesophageal-junction cancer (cancer between the distal part of the     oesophagus, and proximal part of the stomach/GEJ-cancer) is increasing in Denmark with more     than 400 patients per year. The 5-year overall survival is less than 10% for the 2/3 of the     patients, which are not considered resectable. Even for the 1/3, which is treated with     surgical intervention and neoadjuvant chemotherapy the overall-survival is approximately 30%.      The current Danish intended curative treatment consists of esophagectomy (surgical resection     of the oesophagus with extended lymphadenectomy in abdomen and thorax (removal of     lymphnodes)). Furthermore, perioperative chemotherapy consists of 6 series neoadjuvant     chemotherapy (3 series before, and 3 series after operation).      Unresectable patients receive palliative chemotherapy and no resection. Peritoneal washing     cytology (PWC) is a recommended prediagnostic modality in gastric cancer patients. The method     is used to detect free peritoneal cancer cells in the abdominal cavity even when macroscopic     carcinomatosis is not present (i.e. the cancer has spread to other parts of the abdomen).      Carcinomatosis can be found in up to 19% in gastric cancer patients often in the peritoneum.     Positive peritoneal cytology (C1) can be identified in up to 7% of gastric cancer patients     without metastases (C1M0), i.e. malignant cells can be identified in the peritoneal washing,     but tumor spread has not been identified.      Lots of studies indicate that C1-disease is an independent prognostic predictor for decreased     survival, and increased recurrence rate, comparable with M1 patients (i.e. patients with     distant metastases).      The American Joint Committee on cancer recommends that C1 patients should be treated     non-surgically - even when M1 disease has not been identified.      On the basis of the above, PWC can be used to identify patients at greater risk for     recurrence, and thereby not candidates for intended curative treatment.      It is a fact, though, that C1M0 patients have a better survival than C1M1 patients.     Currently, there is no level-1 evidence for specific treatment of C1M0 patients, why further     research is required to approach this patient group in the most comprehensive way. The focus     group of our study is therefore C1M0 patients, because of the difference in opinions.     Furthermore most evidence is based on gastric carcinomas, why GEJ-cancer patients are the     group, we will examine.      Purpose:      Peritoneal washing cytology (PWC) is performed as a standard prediagnostic modality at     Rigshospitalet, for patients with gastric- and GEJ cancer, considered resectable at preceding     multidisciplinary conference. Most studies in the past 20-years have focused on gastric     cancer, and not specifically GEJ-cancer.      This study will determine the usefulness of peritoneal washing cytology, and thereby     verifying our own standard regarding GEJ-cancer. Furthermore, we will determine the effect of     neoadjuvant chemotherapy on free peritoneal tumor cells and its correlation with overall     survival.      This study is intended as a validation of our own standard.   "
91719|NCT02085551|"     The primary objective of this retrospective case review study is to determine the safety and     effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of     patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a     retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be     enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured     by TIMI scores and procedural serious adverse events are assessed and recorded.   "
91720|NCT02085538|"     Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected     to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance     recommends a study in subjects with renal impairment when the drug is likely to be used in     patients with impaired renal function. Palbociclib is intended for chronic use in cancer     patients who may have some degree of impaired renal function.   "
91721|NCT02085525|"     A retrospective chart review of patients receiving concurrent chemoradiotherapy for     oropharynx cancer was performed to compare clinical data for patients treated prior to the     initiation of the NP clinic with those subsequently seen weekly in the NP clinic. The     variables studied included; rate of hospitalization, dose completion and dose reductions. The     results revealed an overall improvement in all variables for those patients seen in the     weekly NP clinic.      To further analyze this data a randomized, prospective study is proposed to validate the     findings of the retrospective study. It is predicted that a weekly NP led clinic will     decrease costly hospitalizations, increase patient treatment completion and improve overall     patient quality of life and satisfaction.   "
91822|NCT02084186|"     The purpose of this study is to determine whether moxibustion is effective to mild and     moderate ulcerative colitis and the effect of moxibustion on metabolism.   "
91722|NCT02085512|"     The proposed work will evaluate the ability of neurocognitive retraining of executive     functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma     exposure and thereby prevent PTSD. The scientific rationale for this work is the hypothesis     that impaired emotional regulation interferes with the expected recovery from the early     responses to traumatic events, leading into a chronic disorder. In an initial phase the     investigators will recruit 20 recently traumatized participants among trauma survivors     admitted to a general hospital emergency room and test the planned intervention's acceptance     and right 'dosing'. In the second phase the investigators will enroll 80 recent survivors     into a randomized controlled study of the new intervention. The intervention will consist of     web-based neurobehavioral training interventions that instill an emotional bias toward     positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional     distraction, and enhance executive functioning. Control participants will complete web-based     video games that do not have emotion-regulatory benefits. Outcome measures will include     improvement in neurocognitive functioning and in PTSD symptoms.   "
91723|NCT02085499|"     The use of non-invasive methods of respiratory support to reduce complications of prolonged     invasive mechanical ventilation in preterm infants has increased.      The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the     interval between mechanical breaths is fixed and is determined by the frequency dialed by the     clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical     breaths delivered at fixed intervals can occur at different times over the inspiratory or     expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar     to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous     inspiration. This has been achieved by using techniques to detect the infant's spontaneous     inspiration.      The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to     be determined.      This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on     ventilation and gas exchange in premature infants who require supplemental oxygen.      The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation     (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and     reduce breathing effort.      The objective of the study is to compare the effect of flow synchronized-NIMV to     non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing     effort, apnea and chest wall distortion in preterm neonates with lung disease.   "
91724|NCT02085486|"     The puncture of the vascular access in hemodialysis patients remains challenging even in the     hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource     wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor     patient satisfaction.      The use of ultrasound by emergency department nurses and technicians without prior ultrasound     experience in patients with difficult intravenous access showed in several studies to be very     efficient. The investigators expect to achieve similar results in cannulation of AV shunts by     the dialysis nurse staff after a short learning program.      To show this, the investigators aim to conduct a trail where standard cannulation technique     (inspection, palpation) will be compared with the ultrasound-assisted method in terms of     efficacy, safety and patient satisfaction.   "
91728|NCT02085434|"     The American Academy of Pediatrics (AAP) recommends a staged approach for pediatric practices     to manage the growing problem of pediatric overweight and obesity, starting with Stage 1,     Prevention Plus, which encourages families to improve basic lifestyle choices related to     eating and activity in order to improve BMI status. This study will test the effectiveness of     an innovative FITLINE telephone counseling program for overweight and obese 8-12 year olds     seen in pediatric practices where nutritionists coach parents in improving their child's diet     and physical activity, to reduce BMI. If found to be effective, the FITLINE program will     provide a model for widespread implementation of Stage 1, Prevention Plus of the AAP expert     committee recommendations through pediatric practices nationwide.   "
91729|NCT02085421|"     The proposed pilot study is a randomized controlled study to assess effectiveness of     transcranial direct current stimulation (tDCS) to enhance cognitive remediation therapy in     patients with psychotic disorders. tDCS. Patients will be randomized into two arms: active     tDCS vs. sham tDCS. The active tDCS will be applied at a current of 1-2 mA (milliamperes) via     two saline soaked electrode sponges (3 cm x 4.5 cm) applied to the side of the head. The     investigators hypothesis is that the use of tDCS will enhance the improvement seen with     cognitive remediation therapy.   "
91730|NCT02085408|"     This randomized phase III trial studies clofarabine to see how well it works compared with     daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in     treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in     chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill     more cancer cells. It is not yet known which chemotherapy regimen is more effective in     treating acute myeloid leukemia.   "
91731|NCT02085395|"     To evaluate the efficacy of SR-T100 gel by observing the lesion size (length x width x     height) of human cutaneous squamous cell carcinoma in situ (Actinic Keratosis and Bowen's     Disease) reduced at least 75%.   "
91732|NCT02085382|"     A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness     in increasing the rate of weight gain among low birth weight neonates.   "
91733|NCT02085369|"     Following obesity surgery gastric bypass (GBP) patients usually lose more than 50% of their     former obesity within a relatively short time (~ 2 years). But knowledge about the underlying     psychological and biological mechanisms of decline in body weight, however, is still lacking.     This project intends to investigate whether obesity surgery is associated with patients'     cognitive ability and / or gene expression and metabolomics.   "
91831|NCT02084069|"     The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory     agent can be effective in preventing from atrial fibrillation incidence in patients whom     undergone open cardiac surgery for their heart valve repair.   "
91832|NCT02084056|"     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose     combination (FDC) tablet containing linagliptin and metformin extended release compared to     the free combination of linagliptin and metformin extended release.   "
91734|NCT02085356|"     This study will test the effectiveness of a behavioral intervention to increase Prevention of     Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive     pregnant women. This study will also determine whether the participation of male partners     will have additional positive impact on PMTCT uptake. The intervention will utilize a     combination of both gender-concordant groups and individual or couples counseling strategies,     before and after birth. During antenatal care, the intervention will use a gender-concordant     group format to address PMTCT information, HIV disclosure, coping with stigma, intimate     partner violence, and adherence to the overall PMTCT protocol. Just prior to birth and     following birth, the intervention will shift to individual or couples-based counseling,     targeting medication adherence, safer infant feeding, and family planning. It is hypothesized     that women attending the intervention will be more likely to properly take HIV medication     before birth and provide it to their infants. Additionally, it is hypothesized that male     partner involvement will further increase the likelihood that mothers will take their HIV     medication as prescribed and provide it to their infants.   "
91735|NCT02085343|"     This study tests whether a single session of exposure therapy may be enhanced by the addition     of anti-phobic actions beyond the mere fading of safety behaviors. A total of 100 acrophobic     participants will be randomly assigned to receive standard exposure therapy (EXP), exposure     therapy with safety behavior fading (EXP + SBF), exposure with safety behavior fading and     anti-phobic actions (EXP + SBF + AA), or to a wait-list control group (WL).   "
91736|NCT02085330|"     Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is     about 15-20% of the population over the age of 65. The most common forms of dementia among     the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular     dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of     coexisting of AD and VD among the dementia patients, defined as mixed dementia.      Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also     considered as a prodromal phase of both VD and AD. Its basic clinical features include:     cognitive concern, reflecting a change in cognition, reported by the patient or informant     (i.e., historical or observed evidence of decline over time), with objective evidence of     impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as     preservation of independence in functional abilities and not being demented (i.e., no     significant impairment social or occupational functioning).      Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases for     more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen in     plasma to a level sufficient to support tissues with minimal oxygen supply carried on by     hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric     oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it     seems that HBOT might be an efficient and clinically feasible method capable of increasing     tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically     vascular-lesioned areas during the post microvascular lesion phase.      This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT     in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.   "
91737|NCT02085317|"     In this study the investigators have aimed to evaluate morphology and reactivity of cutaneous     microcirculation in patients with lepromatous leprosy. Ten patients, without any other     comorbidity were compared to ten controls without leprosy or any other comorbidity, using the     Cytoscan® [orthogonal polarization spectral (OPS) imaging], Fourier analysis of laser Doppler     signal to evaluate vasomotion (rhythmic spontaneous oscillation of arteriolar diameter) and     laser Doppler flowmetry associated to iontophoresis of vasoactive substances (acetylcholine     and sodium nitroprusside).   "
91779|NCT02084758|"     Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate     solution) and the placebo, separated by a 1 wk washout period. The investigators will test     the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic     efficiency in patients with COPD compared to the placebo.   "
94774|NCT02045602|"     The purpose of this study is to determine the safety and tolerability of VCN-01 either     administered alone or in combination with Abraxane®/Gemcitabine, and to determine the     recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.   "
91738|NCT02085304|"     A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to     control. Recent studies show that survival improves for patients who get aggressive surgery     to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment. Surgery,     RT and chemo are part of regular cancer care for GBM. RT is usually done in daily doses 5     days a week over about 6 weeks. Beams of radiation are aimed at the tumor site plus some of     the normal brain tissue around the tumor area. GammaKnife® (GK) radiosurgery also delivers     radiation but in a larger dose over one day. GK sends beams to a precise target (tumor     location) and very little normal brain tissue that is nearby. This study will compare GK     treatment to the usual RT treatment after surgery, and with chemo.      We want to know:        -  How well each treatment keeps the tumor from growing back.        -  What the effects (good and bad) of the treatments are.        -  How you rate your quality of life.        -  How the treatment affects your ability to think, understand, reason, and remember.        -  How you rate your ability to think, understand, reason, and remember.        -  If using a certain type of MRI scan can show the difference between new tumor growth and          changes caused by treatment.        -  If certain features found in tumor cells can help doctors predict how tumors will          respond to treatment.   "
91739|NCT02085291|"     Increase in MAP from 65 mm Hg to patients' usual level by fluid improved sublingual     microcirculation in early septic shock patients despite EGDT.   "
91740|NCT02085278|"     This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation     (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients     considered for this trial are 21 years and younger with AVM suitable for embolization     treatment (a procedure used to block the abnormal connection between the arteries and veins     of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate     (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure     to block the abnormal connection).   "
91741|NCT02085265|"     The purpose of this project is to conduct a proof of concept study in patients with probable     Alzheimer's Disease who have mild to moderate hypertension, in order to determine if there is     less global brain atrophy over one year, as measured by ventricular enlargement as a primary     outcome measure, when patients are randomized to treatment with an angiotensin receptor     blocker compared to an Angiotensin Converting Enzyme inhibitor (ACEI).   "
91742|NCT02085252|"     The purpose of this study is to assess two treatment strategies (leuprorelin treatment and     active surveillance without androgen deprivation) for indolent prostate cancer and to compare     their therapeutic benefit for management of patients with low-risk, localized prostate     cancer.   "
91744|NCT02085226|"     Title: A C E S Study: Can an arts based creative engagement intervention (CEI) following     stroke improve psychosocial outcomes? A feasibility trial of a creative engagement     intervention for inpatient rehabilitation.      This is a feasibility randomised controlled trial of a novel intervention for stroke     rehabilitation examining effects of participation in visual arts activities on psychosocial     outcomes after stroke.      The investigators hypothesise that participation in a visual arts based intervention (CEI)     will improve stroke recovery variables, mood and self-esteem in stroke survivors receiving     in-patient rehabilitation compared to viewing a portfolio of artwork.      The results of the study will inform a sample size calculation for a full trial.   "
91745|NCT02085213|"     A retained placenta (RP) is a complication after a normal birth, which affects nearly 11,000     women in the UK per year. This is where the placenta is not delivered spontaneously after     giving birth. It is a major cause of postpartum haemorrhage (major loss of blood) which can     lead to the death of the mother. The recommended treatment for RP is a surgical procedure -     manual removal of placenta (MROP). This is a painful and unpleasant intervention for the     women, involving additional hospital stay, and is an expensive outcome for the NHS. It is     widely recognised that non-surgical management options for RP are limited and it has been     recommended that research is needed into new medical treatments for RP. New effective     treatments for RP would dramatically reduce the number of women requiring MROP with the     operation being restricted to the small minority of women with particularly stuck placentae.     The reduction in operative interventions would have cost benefits for the NHS and also for     women in terms of increased satisfaction, less separation of mother and baby immediately     after birth, and reduced morbidity.      This study will try to prove the clinical and cost effectiveness of a known treatment for     angina, Glyceryl trinitrate (GTN) used to treat RP. The investigators will compare GTN     against a placebo (dummy treatment) in a randomised controlled blinded trial (GOT-IT).      The GOT-IT Trial will be conducted in two phases. The first phase will involve an internal     pilot study where the aim will be to test out and refine trial procedures in a small number     of hospital sites. The second phase will be the main trial where recruitment will be extended     to a larger number of hospitals in order to determine clinical and cost effectiveness.   "
91746|NCT02085200|"     The purpose of this study is to determine if stabilizing the scapula (shoulder blade) during     a common shoulder stretch is more effective at improving shoulder range of motion than not     stabilizing the scapula. Investigators hypothesize that scapular stabilization during     horizontal adduction stretching will demonstrate greater gains in shoulder range of motion     than stretching without scapular stabilization.   "
91747|NCT02085187|"     Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major     impact on the lives of individuals. An essential element in the treatment of COPD is     rehabilitation of which supervised training is an important part. However, not all     individuals with severe COPD can participate in the rehabilitation provided by hospitals and     municipal training centres due to distance to the training venues and transportation     difficulties. The aim of the feasibility study was to evaluate an individualised home based     training and counselling programme via video conference to patients with severe COPD after     hospitalization with regard to safety, clinical outcomes, patients' perception,     organisational aspects and economic aspects.   "
91748|NCT02085161|"     The primary objectives of the study are to explore the effect of treatment with orally     inhaled tiotropium + olodaterol fixed dose combination with and without exercise training,     and tiotropium comparing to placebo, on top of behavioural modification in improving exercise     capacity in patients with COPD   "
91749|NCT02085148|"     Dose escalation phase of the study :      To define the safety profile, maximum tolerated dose (MTD) and recommended phase II dose     (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on/1- week-off     schedule in repeating cycles of 28 days in pediatric subjects with solid malignant tumors     recurrent or refractory to standard therapy. To characterize the pharmacokinetics (PK) of     regorafenib The dose escalation phase of the study has been completed.      Expansion phase:      To define the safety profile, MTD and the RP2D of regorafenib administered orally in     combination with backbone chemotherapy (vincristine and irinotecan) at relapse in pediatric     subjects with rhabdomyosarcoma (RMS) and other solid malignant tumors recurrent or refractory     to standard therapy.   "
91750|NCT02085135|"     This is a Phase 3 study designed to evaluate the safety and tolerability of two titration     schedules for ALKS 5461.   "
91751|NCT02085122|"     Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF)     subjects, hampering performance in activities of daily living. In this context, noninvasive     ventilation (NIV) has been used to minimize such impairment, increasing functional capacity     Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A     randomized crossover clinical trial with allocation concealment consisted of two experimental     phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level     ventilation was performed. Any type of ventilator support was offered during control phase.     Functional capacity was assessed by cardiopulmonary exercise test on a treadmill.   "
91759|NCT02085018|"     Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause in which areas of normal     lung tissue are replaced by scars. As a result it becomes harder for the lungs to extract     oxygen from the air. IPF is commonly progressive, and around 50% of patients diagnosed with     the disease die after approximately 3 years. The most common, troublesome symptoms of IPF are     breathlessness on exertion, and cough. No drug treatments have been unequivocally shown to     improve the death rate, or to significantly impact upon symptoms, in IPF.      In recent years it has been recognised that cough can be caused by small amounts of liquid     coming up from the stomach and going down the wrong way into the lungs, a process commonly     known as reflux. As liquid in the stomach is usually acidic, patients' lungs may repeatedly     be exposed to small amounts of acid. Reflux is unusually common in IPF and could potentially     contribute to the debilitating cough found with the disease. However there are many potential     causes for cough in IPF.      Stomach acid can be efficiently switched off by drugs called proton pump inhibitors, one     of which is called omeprazole. If reflux of stomach acid does contribute to cough in IPF,     omeprazole might be expected to reduce cough. The purpose of this study is therefore to test     whether omeprazole does reduce cough in patients with IPF. Sixty patients with IPF will be     randomly allocated to have 3 months of omeprazole or a placebo. Neither the patient nor the     doctor will be aware which treatment has been given, ie this is a randomised double-blind,     placebo--controlled trial. Patients' cough frequency will be measured before and after     treatment and the change in cough frequency compared in those receiving omeprazole and those     receiving placebo. Change in cough frequency is the main thing we aim to compare, but a range     of other measurements will be assessed such as the numbers of patients eligible to take part,     agreeing to randomisation and providing outcome data, patients' lung function, symptom     scores, the amount of reflux, and the amount of inflammation in the lungs.   "
91752|NCT02085109|"     Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein     (LDL) cholesterol concentrations, a substantial residual cardiovascular risk is still     present. An additive strategy to further lower this residual risk may be via raising     high-density lipoprotein (HDL) cholesterol concentrations, and in particular those of its     major protein constituent apolipoprotein A-I (apoA-I). However, recent evidence shows that     raising HDL cholesterol (HDL-C) concentrations not always causes a reduction in     cardiovascular disease (CVD) risk. To understand this it is important to know what are the     targets and molecular mechanisms that underlie a shift to a HDL fraction with     cardioprotective activities. There is increasing evidence that particularly the apoA-I     proteins in the HDL fractions are atheroprotective. It is important to verify whether the     effect of an intervention actually increases apoA-I production since that results in the     formation of de-novo small pre-beta HDL particles that have full capacity to resorb     cholesterol from the arterial wall and return this to the liver for secretion (reverse     cholesterol transport). The investigators here propose to evaluate, in a double-blind human     intervention study, the difference in intestinal apoA-I gene expression, of healthy subjects,     after consumption of a high fat (HF) or low fat (LF) meal. Additionally the investigators     propose to evaluate the effect of theobromine on intestinal apoA-I expression. Based on     several studies, theobromine improved cardiovascular risk parameters among which an elevation     in apoA-I and HDL cholesterol concentrations. It is however unknown whether this effect of     theobromine originates from elevated apoA-I production, which suggest improved functionality,     or decreased clearance, suggesting reduced functionality. The investigators therefore propose     to also evaluate if the usage of theobromine is a better way to increase intestinal apoA-I     mRNA and protein expression, than consumption of a HF meal. The investigators will do this in     the same double-blind human intervention study. The theobromine will be added in a third arm     in a LF condition.      Study design: The proposed study will have a randomized, double-blind cross-over design. The     total study duration will be 17 days, consisting of 3 experimental days with postprandial     tests, each separated by a 1 week wash-out period.      Study population: Ten apparently healthy male subjects, aged 18-60 years, without a history     of any gastrointestinal disorders or complaints.      Intervention: During the three experimental days, subjects will consume a milkshake: one HF     milkshake, one LF milkshake and one LF milkshake supplemented with 850 mg theobromine. Total     follow-up during each of the postprandial tests is 5 hours.   "
91753|NCT02085096|"     Problem-solving therapy programs have been shown to be effective among parents of children     diagnosed with cancer. Efforts have been made to apply this same strategy to     spouses/significant others of men diagnosed with prostate cancer. The purpose of this study     is to test the efficacy of problem-solving therapy on the spouses of prostate cancer     patients.   "
91754|NCT02085083|"     The transition from pediatric to adult IBD care can be stressful and wrought with challenges     including access to care and establishment of new physician-patient relationships. There a     few studies which characterize patterns of healthcare utilization during this critical period     and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization in     academic centers and optimized communication with patients during the pediatric-adult     transition period is associated with lower hospitalizations and surgery. This hypothesis will     be addressed by a randomized clinical trial to determine the impact of monthly regular     telephone contact with an IBD Registered Nurse versus standard of care during the     pediatric-adult transition period. Outcomes will include healthcare utilization,     health-related quality of life, patient satisfaction, and treatment adherence over 12 months     of follow-up. Randomization and analyses will be stratified by whether subjects were     transferred to adult care in an academic center or in a community practice. We hope that this     research will facilitate optimal delivery of healthcare during the pediatric-adult     transition.   "
91755|NCT02085070|"     The purpose of this trial is to study the activity of MK-3475 in untreated brain metastases     from melanoma or non-small cell lung cancer.   "
91756|NCT02085057|"     Individuals with anorexia nervosa (AN) have long been observed to demonstrate symptoms in     common with obsessive-compulsive disorder (OCD), in particular, an obsessive fear of normal     weight leading to dangerous food restriction, as well as many compulsive rituals about food.     Both AN and OCD are seriously handicapping and often resistant to conventional therapies.     Given that the two conditions often co-occur and are associated with still unknown genetic     risk factors, the aim of this project is to identify their shared and distinct patterns of     brain activity.      The investigators propose to use functional magnetic resonance imaging to compare brain     response among adolescents with AN, OCD, and age-matched healthy individuals. Specifically,     this study will investigate function of distinct brain circuits related to core aspects of     these related disorders. The investigators use three tasks related to set shifting, global     vs. local processing, and reward. Based on evidence of deficits in cognitive flexibility and     ability to change behavior, the investigators hypothesize that adolescents with AN and with     OCD will show hypoactivity of frontostriatal circuitry during cognitive tasks, and     adolescents with AN will show hyperactivity in limbic regions in a reward task.      This study is the first to directly compare brain activation patterns using functional     neuroimaging in AN and OCD. The goal is to determine how abnormal brain activity relates to     symptom formation, what accounts for shared characteristics amongst these disorders, and     whether deficits in specific circuitry underlie their unique defining features. The study of     shared and unique elements of functional brain circuitry reflects a new, emerging approach to     the classification of psychiatric illness, one based on identifying unique combinations of     biological risk factors that link related conditions. This approach is widely believed to be     a critical step forward in developing more brain-relevant targeted strategies for     preventative interventions.   "
91757|NCT02085044|"     The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF)     distributions have a greater impact on children's health than the standard RUSF distributions     during the hunger gap period (june to september). We estimated that the 12 month RUSF will     decrease the incidence of severe acute malnutrition by 33% compared to an administration only     during the hunger gap period (4 month a year).   "
91816|NCT02084264|"     To compare the accuracy and feasibility, curvature correction and clinical outcomes of     pedicle screw instrumentation with versus without robotic guidance, in pediatric and     adolescent scoliosis patients   "
91758|NCT02085031|"     -  To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular          stapler was the most common used method during laparoscopy-assisted total gastrectomy          for gastric cancer, even though it was not totally laparoscopic surgery in which          intracorporeal anastomosis should be performed.        -  To gain potential clinical benefits from a smaller length of minilaparotomy and an          easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y          anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic          total gastrectomy was adopted by experienced surgeons recently.        -  However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally          inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety          of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular          stapler based on a well designed randomized controlled trial is needed.   "
91760|NCT02085005|"     Primary Objective:      Efficacy: To assess the progression-free survival rate at 10 months in patients on     maintenance therapy with capecitabine plus aflibercept.      Secondary Objectives:      To evaluate:        -  Efficacy: Progression Free Survival (PFS)        -  Efficacy: Overall Survival (OS)        -  Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid          Tumors (RECIST version 1.1) criteria        -  Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L        -  Safety      Exploratory Objective:      To collect blood and tumor samples to perform investigations for potential biomarker testing.   "
91761|NCT02084992|"     This study will randomize participants with a diagnosis of congestive heart failure and at     least one risk factor for hospitalization to either a tablet computer and web based disease     management program or a telephone based disease management program. Both interventions are     home based with heart failure education and symptom monitoring provided by nurse managers.     The nurse managers are in close communication with both the participants and the     participants' physicians . The components of the disease management program have been     developed at Tufts Medical Center and the New England Quality Care Alliance with studies     showing improved clinical outcomes, including reduced hospitalizations. The goal of this     study is to transition this successful home monitoring and disease management program to a     table computer and web-based implementation to both improve clinical outcomes (reducing     hospitalizations and improving self-perceived health status) and improve provider-patient     satisfaction. We hypothesize that the tablet computer based disease management will decrease     heart failure hospitalizations.   "
91762|NCT02084979|"     This two-year randomized controlled trial of clinical outcomes seeks to evaluate the     superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality,     cost and outcomes of care over the usual care for adults referred from primary care clinics     for psychiatric evaluation and treatment.   "
91763|NCT02084966|"     Optical coherence tomography (OCT) is a rapidly emerging imaging modality that can function     as a type of optical biopsy, providing non-invasive cross-sectional images of tissue     architectural morphology in situ and in real-time. This proposal will demonstrate that OCT     has the ability to provide novel and valuable histopathological information regarding donor     kidneys that can be used to predict post-transplant renal function. These investigations will     result in a major breakthrough in increasing the number of healthy kidneys available for     transplantation by making the most efficient use of available donor kidneys, eliminating the     possible use of bad donor kidneys, providing an accurate measure of expected post-transplant     renal function, and allowing better distinction between post-transplant immunological     rejection and ischemic-induced acute renal failure.   "
91764|NCT02084953|"     The purpose of this study is to determine whether BMS-791325 has an effect on the     electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).   "
91765|NCT02084940|"     PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age     characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome     is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation     syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH     antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian     response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was     introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also     for the induction of multiple follicular growth in a program of oocyte donation. The aim of     this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of     controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.   "
91766|NCT02084927|"     The aim of the current study is to evaluate, in a prospective cross-over, randomized study,     the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits     and cognitive impairment after anterior skull base meningioma tumor removal.   "
91841|NCT02083939|"     The purpose of this study is to find out whether it is necessary to prophylactically treat     patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is     that it is not necessary to pretreat patients with antibiotics if the operation is minimally     invasive with a mesh placed at the defect.   "
91767|NCT02084914|"     Research question:      Population: women with unexplained infertility. Intervention: endometrial scratching by     pipelle for women with unexplained infertility.      Comparison: to compare with non endometrial scratching for women with unexplained     infertility.      Outcome: the biochemical pregnancy rate.      Research hypothesis:      Null hypothesis: there is no difference in the rate of pregnancy between scratching and non     endometrial scratching in women with unexplained infertility.      Alternative hypothesis: there is difference in the rate of pregnancy between scratching and     non endometrial scratching in women with unexplained infertility.   "
91768|NCT02084901|"     The use of a biodegradable polymer has the potential to reduce the sustained inflammatory     response of the arterial wall, facilitating re-endothelialization and minimizing the risk of     thrombus formation and late restenosis. In the study, we are going to two biodegradable     polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by     optical coherence tomography at 3 months after stent implantation.      The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to     Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The     secondary endpoint is clinical outcomes up to 1 year.   "
91769|NCT02084888|"     The purpose of this study is to determine the prognostic impact of the presence of chronic     total occlusions (CTO) of the coronary arteries in patients undergoing coronary angiography     and PCI.   "
91770|NCT02084875|"     This study will evaluate the drug behavior and safety of a single dose of the 11 milligram     tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken     after eating a high fat meal (the effect of food). This will be compared to the drug behavior     and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release     formulation when taken after a 10 hour fast.   "
91771|NCT02084862|"     TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and     efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided     percutaneous tracheostomy.   "
91807|NCT02084381|"     The medium cut-off dialysis membrane has been developed to provide a significantly extended     molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane     allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a     still limited permeability for albumin (68 kDa).      The main goal of this project is the evaluation of the new, highly porous and selective     dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in     hemodialysis mode and to study its potential to improve chronic inflammation.   "
91772|NCT02084849|"     The purpose of this study is to find out if radiology tests of the kidneys as opposed to     glomerular filtration (GFR) tests (GFR test - a lab test that measures kidney function)     follow progression of polycystic kidney disease (PKD) the best. PKD patients at risk for     progression to renal failure (dialysis or transplantation) have been identified and include     those who have been diagnosed with high blood pressure early, the presence of the PKD1 gene     (the inherited abnormality responsible for the majority of PKD), men as opposed to women,     those with episodes of visible blood or increased protein in their urine, and women who have     experience more than three pregnancies. Individuals who are diagnosed with PKD in the first     year of life or in utero (before birth) are also at high risk for progression to renal     failure.      This study will also facilitate understanding of human diseases at the cellular and molecular     level. We will be identifying genetic factors that may influence the severity of polycystic     kidney disease (PKD). You are being asked to provide a sample of blood for the purpose of DNA     or other biochemical analyses.   "
91773|NCT02084836|"     Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular     disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder     disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United     States (Calle et al., 1999; Flegal et al., 2005). In the US, 65% of adults are overweight or     obese (Hedley et al., 2004). Unfortunately, the treatment of choice for obesity (behavioral     weight loss treatment) only results in a 10% reduction in body weight on average and most     patients regain this weight within a few years (Jeffery et al., 2000). Further, most obesity     prevention programs do not reduce risk for future weight gain (Stice, Shaw, & Marti, 2006).     The limited success of treatment and prevention interventions may be due to an incomplete     understanding of the processes that increase risk for obesity. Recent data suggest that obese     adults show abnormalities in reward from food intake and anticipated food intake relative to     lean adults, but the precise nature of these abnormalities is unclear and it has not been     established whether these abnormalities predate obesity onset or are a consequence. It is     vital to elucidate risk factors for obesity onset to advance understanding of etiological     processes and determine the content of prevention and treatment programs.      The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by     virtue of having two obese parents, show abnormalities in reward from food intake     (consummatory food reward) and anticipated reward from food intake (anticipatory food reward)     compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities     in consummatory and anticipatory food reward increase risk for weight gain and obesity onset,     (3) examine moderators that may amplify the relations of consummatory and anticipatory food     reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory     food reward in those participants who show obesity onset relative to those not showing     obesity onset.   "
91774|NCT02084823|"     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors     into immunosuppressed mice, preventing an assessment on the immunologic interactions and     effects of CSCs. In this study, the investigators examined the vaccination effects produced     by CSC-enriched populations from histologically distinct murine tumors after their     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic     and more effective as an antigen source than unselected tumor cells in inducing protective     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor     immunity.   "
91775|NCT02084810|"     This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence     of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.   "
91776|NCT02084797|"     This primary aim of this study was to critically assess whether or not sweat water content     and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone     (arginine vasopressin or AVP) acting on the Vasopressin 2 receptor (V2R) during exercise.     Secondary aims were to evaluate running performance and core temperature to further     characterize the role of AVP in the coordinated balance of fluid and temperature homeostasis     during exercise. The primary hypothesis was that activation of the V2R in sweat glands would     result in water reabsorption and fluid conservation during endurance exercise.   "
91777|NCT02084784|"     The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early     breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel     surgical navigation system.   "
91778|NCT02084771|"     The purpose of this pilot trial is to determine the safety and feasibility of using oral salt     and water loading compared to intravenous saline for the prevention of contrast-induced acute     kidney injury in patients with chronic kidney disease receiving a contrast-enhanced CT scan.   "
91780|NCT02084745|"     Introduction:      Boston keratoprosthesis (KPro) is a piece of specialized plastic that replace sick cornea     (transparent structure at the front of the eye) in patients who have failed or those who are     expected to have poor results with traditional corneal transplantation.      While the Kpro can offer dramatic improvement in vision, it is also associated with several     complications. Glaucoma (optic nerve damage due to high pressure inside the eye) is one of     the most common complications after KPro surgery and can potentially cause irreversible     vision loss.      The implantation of a glaucoma drainage device (GDD), a tiny tube that drains the liquid     inside the eye by bypassing the natural drainage system, is an effective option to lower the     eye pressure in patients with KPro. Given the frequency and potentially devastating effects     of glaucoma among KPro patients, some surgeons recommend to put in a GDD as a preventative     measure. However, there is no consensus on when is the best timing to perform such surgery in     relation to the Boston Kpro surgery.      Hypothesis:      For patients undergoing the Boston KPro surgery, implanting a GDD simultaneously, at the time     of surgery, is more efficacious than at 6 months later, in the prevention of the progression     of glaucoma and in maintaining better visual functions.      Methods:      We aim to recruit 40 patients over 4 years. Recruited patients will be randomly assigned to 2     groups: 1) simultaneous GDD implantation at the Boston KPro surgery, and 2) GDD implantation     6 months after the Boston KPro surgery.      Once recruited, patients will be followed before the KPro surgery, postoperative day 1, week     1, month 1, 3, 6 and 12. Standard ophthalmological exam will be performed at each visit.     Additional non-invasive glaucoma tests and evaluation (visual fields and optic nerve photo)     will be performed on day 1, month 1, 3, 6 and 12.      For patients assigned to group 2, a GDD will be implanted 6 months after the KPro surgery.     They will have additional follow-ups on post-GDD surgery day 1, week 1 and month 1.      Results of visual acuity, visual fields, optic nerve evaluation and complications will be     compared between the two groups to determine the better timing of GDD implantation.   "
91808|NCT02084368|"     The research is to study the effectiveness and safety of combined lumbar plexus and sciatic     nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee     replacement.There have be some papers which supported that combined lumbar plexus and sciatic     nerve block may be more suitable for the old men.   "
91809|NCT02084355|"     Although opioid rotation is well known treatment modality in reducing pain and opioid-induced     neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid     escalation is more effective in controlling significant pain in cancer patients under opioid     medication.      - The purpose of this study is to determine effective therapy out of opioid rotation and     opioid dose escalation in patients with moderate to severe cancer pain who have been already     treated with strong opioid.   "
91781|NCT02084732|"     Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and     C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a     rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in     Colombia, 2010).      Although this disease has a low rate of attributable mortality, the costs arising from     treatment, monitoring, and disabilities among affected patients and their families are high     for the health system.      The therapeutic approach to differentiated thyroid cancer once it starts progressing is     limited; there are no truly favorable treatment options for patients with advanced thyroid     cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.      Molecular biology now allows the identification of the effects of mutations and alterations     in the proteins that participate in cell signaling which account for dedifferentiation,     invasiveness, and the progression of neoplastic cells.      VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be     addressed by targeted molecular therapy. Its increased expression in differentiated thyroid     cancer has been demonstrated and has been associated with increased growth, invasiveness, and     shorter recurrence-free survival.      Different agents are effective against this tyrosine kinase receptor; nevertheless, taking     into account that it is not solely responsible for tumor progression, according to clinical     study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as     sorafenib and motesanib. These inhibitors have already been tested in phase II studies.      Results from recent phase II research studies using these emerging treatment options have     shown important effects in the therapeutic approach to other solid neoplasms.      Information about the safety of this type of treatment is limited; a need for information     regarding the use of new therapeutic approaches in Colombia is one of the contributions that     the National Institute of Cancer can make to the country through this study.   "
91782|NCT02084719|"     Rapid tests are increasingly used in medical practice, notably to screen for HIV. Their use     has been associated with a faster linkage to care and lower rates of loss to follow up. Rapid     tests are also well accepted by patients and clinicians.      No rapid test is currently approved in Canada for screening of hepatitis C. Hepatitis C     diagnosis is done through based on blood testing and the screening algorithm may require up     to 3 visits to clarify the hepatitis C status.      The Oraquick HCV test is a rapid test done on blood or saliva that can replace the first step     of the regular screening algorithm. With this test the initial screening and the confirmation     test can be done in one visit.      The primary endpoint of this pilot-project is to evaluate clinical characteristics of     Oracquick HCV (sensitivity, specificity, positive and negative predictive values) and to     compare them to those of the standard screening algorithm in a population of active or     ex-users of injected drugs. The project also intend to evaluate if the rapid test can reduce     the rates of loss to follow up and increase the linkage to hepatitis C specialized care. This     last endpoint will be evaluated through phone call follow up 6 months after the screening.      One hundred and fifty patients will be included. Half will be tested with the standard     algorithm and the Oraquick HCV test (group A) and half will be tested only with the standard     algorithm.      Results of group A will be used to determine the clinical characteristics of Oraquick HCV.     Results of groups A and B will be used to evaluate rates of loss to follow up, costs avoided     by the use of the rapid test and linkage to care of infected patients.   "
91783|NCT02084706|"     Jet-injection (J-tip) is a rapid, minimally invasive delivery system that can be used for the     subdermal injection of lidocaine solution for anesthetic purposes. The device has been found     effective in pain reduction during IV catheterization in adults and children and lumbar     puncture in children when compared to placebo saline-jet injection. [1-4].      We believe that administering local anesthetic via J-tip prior to triamcinolone(40 mg/ml)     injection could mitigate pain that occurs during and immediately following injection while     preserving the post-injection pain relief of anesthetic injection. Furthermore, pre-placement     of the jet-injected local anesthetic may obviate the need for the inclusion of local     anesthetic into the triamcinolone injection. This would decrease the amount of fluid     injected, which could have positive pain modulation by decreased tissue disruption.      Objective: To evaluate the effectiveness of needle free jet injection (J-tip) administration     of 2% lidocaine in reduction of the pain experienced during trigger digit 40 mg/ml     triamcinolone injection.      Hypothesis: Needle free jet injection (J-tip) administration of 2% lidocaine will prove an     equal or superior means of pain reduction when compared to 2% lidocaine injection in the     setting of trigger digit triamcinolone injections.   "
91784|NCT02084693|"     Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.   "
91785|NCT02084680|"     Introduction There is compelling evidence for scheduled home visits to improve newborn     health. There is also a growing wealth of evidence to support the use of mobile phones as a     public health tool in low and middle-income countries. UNICEF and WHO have recommended     implementation of home visits for newborn care improvement. In sub Saharan Africa the     evidence for a combined scheduled home visit and mobile phone technology to improve neonatal     health is lacking. In this study the investigators aim to determine the effect of scheduled     home visits by Community Health Workers (hereafter referred to as Village Health Teams-VHTs)     combined with mobile phone consultations on newborn care in Masindi, Uganda.      Methods This is a community intervention trial to be conducted in Masindi and Kiryandongo in     Uganda from May 2013 to June 2014. A mixed method data collection technique will be used. Our     overarching hypothesis is that survival of the newborn requires a continuum of care from     pregnancy to the newborn period. Eight health centres each will be randomly allocated to the     intervention arm and a control arm. Five villages will be randomly selected from each of the     catchment areas of the intervention health centres and one VHT purposively selected from each     of the villages. Intervention arm will receive VHTs equipped with mobile phones making four     scheduled home visits to women while the control arm will receive the standard care for     prenatal and immediate newborn education. VHTs will discuss care for the pregnancy, danger     signs in pregnancy, birth preparation, acquiring needed items for delivery and recommended     newborn care practices. VHTs can also make instant telephone consultations with the midwife     for a second opinion. A closed caller group for the mobile telephone consultation is already     negotiated with Mobile Telephone Network (MTN) a mobile phone service provider to allow lower     tariff rates. Our primary outcome variables of interest are hygienic cord care (specifically     application of substances on the cord), thermal care (specifically delayed bathing of the     baby soon after birth), initiation of breastfeeding within one hour and avoiding pre-lacteal     feeds. Secondary outcomes like completed four antenatal visits, institutionalized delivery     were also assessed.   "
91786|NCT02084654|"     Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients     with type 2 diabetes, has been associated with restoration of the first-phase insulin     response when administered intravenously to patients with type 2 diabetes. In longer clinical     trials, it is associated with progressive decreases in body weight, and improvement in the     dyslipidemia that characterizes insulin resistance, although insulin resistance was not     quantified. The investigators will seek to determine whether exenatide would have similar     effects in individuals who were not diabetic. in particular, the drug effect on beta cell     function and insulin sensitivity would be subject to less confounding by changes in blood     glucose in the prediabetic population, allowing for clearer evaluation of the physiological     effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of     prediabetic insulin resistant individuals, all on a weight loss diet and one group on     exenatide and the other on placebo. The investigators will evaluate restoration of first     phase insulin response, potential glucose lowering effects, including both reversal of     prediabetes and hypoglycemia, and improvement in insulin resistance.   "
91787|NCT02084641|"     Obesity has become an epidemic worldwide. Data from our laboratory and others demonstrate     that most of the excess morbidity from obesity is related to insulin resistance (IR). While     total adiposity correlates with insulin resistance, not all obese individuals are IR. When     obese IR individuals lose weight in response to caloric restriction, even moderate loss of     body fat results in improved insulin sensitivity (IS). With massive weight loss, either     dietary or surgical, even the most IR individuals can completely reverse their insulin     resistance. But why is one individual IR at a BMI of 26 and another IS at a BMI of 35? There     must be differences in the manner in which adipose cells/tissue respond to caloric excess and     weight gain. One potentially unifying hypothesis with regard to obesity-associated insulin     resistance is that those individuals who fail to respond to caloric excess/obesity with     adequate adipocyte differentiation and expanded subcutaneous fat storage capacity develop     increased circulating FFAs, ectopic fat deposition, stress on adipocytes, triggering     localized and systemic inflammation and ultimately insulin resistance in skeletal muscle.      Clearly, the best way to examine the human response to obesity is to challenge overweight     individuals with the need to store excess triglyceride in adipose tissue. Specific aims are:        1. Test the hypothesis that impaired adipogenesis and fat storage capacity are associated          with insulin resistance by comparing 1) cell size distribution; 2) gene markers of          adipose cell differentiation; 3) differentiation of isolated preadipocytes in IR-prone          vs IS individuals subjected to caloric excess.        2. Determine if circulating (daylong FFA, two-stage Insulin Suppression Test) and ectopic          fat (MRI liver, CT abdomen) are worsened to a greater degree in IR-prone vs IS          individuals subjected to caloric excess.        3. Determine whether differences in inflammation and/or innate or adaptive immune response          are associated with insulin resistance by comparing differences in resident dendritic          cells, macrophages and their activation profiles, changes in T-cell subpopulations, and          other inflammatory mediators in IR-prone vs IS individuals who are subjected to caloric          excess via overfeeding.        4. Exploratory: Evaluate IR-prone vs IS individuals for evidence of hypoxia and          insufficient angiogenic response in response to caloric excess.   "
91788|NCT02084628|"     This is an open-label, multi-center study involving babies 0-2 months of age who have liver     problems (pathology) and need to have their liver and possibly, the bile ducts imaged using     magnetic resonance imaging and injection of a contrast agent (dye). This agent is called     Eovist. It has been marketed since 2004 and used in many countries all over the world.      The baby will have blood tests before and after the imaging is done to make sure that there     are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours     after the injection will be obtained in order to measure how much of the dye is in the blood.     The baby will have an intravenous line which can be used for the blood samples and will not     need to be stick for the blood samples. Several radiologists will evaluate the images. The     family doctor will be contacted to find out what was the diagnosis and treatment after the     results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s)     will be contacted to make sure the that baby did not have any problems, especially with the     skin, joints and eyes.   "
91789|NCT02084615|"     The purpose of this study is to determine whether aspirin taken in the perioperative period     will increase the blood loss associated with open inguinal hernia repairs. A secondary     purpose of this study is to determine if the aspirin administered in the perioperative period     increases the risk of complications associated with open inguinal hernia repairs.   "
91790|NCT02084602|"     There is growing evidence of the emergence of P. falciparum resistance to artesunate (a     derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to     artemisinin would represent an alarming threat to the success of the antimalarial combination     therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been     taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border.      The purpose of this research study, is to assess the in vitro and in vivo efficacy of     combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum     malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia     and other important outcomes.   "
91791|NCT02084589|"     This is a prospective, randomized, double blind study, in which a comparison of patient     controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and     demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being     investigated. The purpose of the study is the assessment of the efficacy of labor analgesia     and maternal satisfaction.      Written informed consent is obtained by all parturients. Non invasive monitor of blood     pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal     heart rate is being placed.      The participants are randomized in two groups, both receiving the same drug (ropivacaine     0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes.     Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10     minutes.      All parturients have to be instructed to self administration of epidural bolus dose when they     experience mild to moderate pain. Both parturient and anesthetist who conducts the study and     treat breakthrough pain, are blind to group assignment.      After the last suture, total volume of epidural infusions of PCEA, total infused drug of PCEA     pump, number of delivered PCEA boluses and manual rescue doses are being calculated. Time of     delivery, mode of delivery, Apgar scores, and overall maternal satisfaction scores, neonate     pH and Hct of the patient (ABGS), as well as possible need of newborn cardiopulmonary     resuscitation are also recorded.   "
91792|NCT02084576|"     To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac     0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract     extraction.   "
91793|NCT02084563|"     The objective of this study is to describe the prevalence and prognostic impact of the most     common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid     Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and     Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone     marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.      Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform     protocol.   "
91810|NCT02084342|"     Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and     blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis.     TXA acts mainly by inhibit the plasminogen activator.      Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von     Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type     plasminogen activator (t-PA), which may cripple its hemostatic effect.      The investigators supposed that if the investigators combine TXA with DDAVP in scoliosis     correction surgery, the blood loss and the transfusion need would be reduced significantly.   "
91833|NCT02084043|"     Using an adult lung bench model of non invasive ventilation, the aim of the study is to     compare an experimental system of breath-synchronized vibrating mesh nebulizer to a     conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled and     lost doses.   "
91834|NCT02084030|"     The aim of this study is to perform a whole-genome linkage analysis for identification of the     susceptibility loci for POCD   "
91794|NCT02084550|"     The detrimental effects of catabolism, insuline resistance and muscle wasting on surgical     outcome is wellknown. This catabolism is especially pronounced in patients with acute or     chronic inflammation (IBD, cancer) and for those undergoing major surgery. Patients with     ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into     both these categories.      To prevent this undesirable catabolism, we will investigate the effects of intravenous     administration of predominantly anabolic amino acids (with an amino acid content equal to     breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism and     intracellular signalling pathways.      Twenty-four patients will be block-randomized by gender in this parallel-group, randomized,     assessor-blinded, placebo-controlled trial to receive either Vaminolac® (Fresenius Kabi) or     saline. Metabolism before and after the intervention will be assessed by palmitate- and amino     acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be     analyzed for differences in intracellular signaling pathways (PI3 kinase, Akt, etc.) as a     measure of cellular activity.      With this study we hope to find evidence for anabolic effects of intravenous amino acids in     j-pouch surgery for ulcerative colitis. The perspective is a potential for primary     prophylaxis of surgical complications, reduction in the length of hospitalization, and     subsequently optimized long-term functional outcome of the pouch.   "
91795|NCT02084537|"     Prospective, multi-center randomized controlled trial comparing Endoscopic Ultrasound (EUS)     Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally     invasive surgical necrosectomy, in patients with symptomatic or infected walled off     pancreatic necrosis (WOPN).   "
91796|NCT02084524|"     Malnutrition priori a major abdominal surgery is frequent and increases morbidity and     mortality. The management of malnutrition has an impact in reducing postoperative     complications. However malnutrition is rarely detected and Guidelines infrequently followed.      Recovery time and nutritional evaluation in elderly patients are major criteria in their     postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its     treatment. It is therefore unsurprising that many validated tools for nutrition risk     screening and nutrition assessment exist for the clinician to use in assisting with the     accurate identification, referral and treatment of patients who are malnourished or at risk     of malnutrition.      And nutritional management must be adapted and based on this evaluation and evolution of the     general status (Guidelines Grade A).      A geriatric evaluation based on a screening of preoperative malnutrition should allow a     better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN)     guidelines.   "
91797|NCT02084511|"     To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution     compared to placebo and the relative effectiveness compared to Celecoxib.   "
91798|NCT02084498|"     The investigators hypothesize, that non-optimally treated carbohydrate counting-naïve     patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates,     and that the metabolic control can be further improved with concurrent use of Accu-Chek Aviva     Expert. Additionally, the investigators propose that carbohydrate counting will lead to     better quality of life as a result of fewer restrictions when eating and less variation in     blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert     will lead to fewer hypoglycemic episodes.   "
91799|NCT02084485|"     The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the     sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of     inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for     patients with Chronic Obstructive Pulmonary Disease (COPD).   "
91800|NCT02084472|"     Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's     essential drug list (EDL) but are not available to most rural patients. To assess whether     accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized     controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two     separate sub-studies were conducted using a randomized controlled single (assessor) blind     trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all     patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG,     petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and     IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines     were continued as prescribed.   "
91801|NCT02084459|"     The purpose of this randomized study is to find out whether using the Danish-developed     nursing intervention guided self-determination (GSD) can improve life skills of the chronic     pain patient.      The hypothesis is using guided self-determination in the treatment of chronic pain patients     will increase the life skills of the patients and thus their life quality in spite of pain.   "
91802|NCT02084446|"     This is a 12-month single center, randomized, open-label, single center study designed to     compare the safety and efficacy of everolimus and very low dose tacrolimus versus     enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant     recipients.      The purpose of this study is to compare safety and efficacy of two immunosuppressive regimens     based on low tacrolimus exposure combined to everolimus or to enteric-coated mycophenolate     sodium (EC-MPS) in de novo kidney transplant recipients.   "
91803|NCT02084433|"     The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized     system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that     anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid     local anesthesia compared to the anesthesia via conventional technique by infiltration.      Design: split-mouth design AND parallel-arm design   "
91804|NCT02084420|"     The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect     between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or     Duodenal ulcer patients with H.pylori positive infection.   "
91805|NCT02084407|"     The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem     cells in order to study the cardiac alterations induced by CTG expansions.   "
91806|NCT02084394|"     Cardiac surgery is associated with multiple events and issues that increase risk for adverse     postoperative neurological outcomes including postoperative cognitive dysfunction. The risk     for postoperative delirium is generally thought to result from some previous health factors     added to the susceptibility of the cardiac surgery process.   "
91811|NCT02084329|"     After a mild traumatic brain injury (mTBI) people often report balance problems. At Parkwood     hospital we have noticed that balance is improved when patients with mTBI wear a weighted     compression vest. This follow up pilot study looks at the immediate effects of weighted     compression vests on participants with altered balance after mTBI. Participants will be     recruited from the Ministry of Health Outpatient Acquired Brain Injury (ABI) Program wait     list. Then each participant will perform a series of balance and walking tests under 2     conditions : 1) wearing a weighted compression vest , 2) not wearing a weighted compression     vest. It will be randomized whether participants wear the vest on the first or second testing     day. Participants will also be asked how confident they are about their balance and how     anxious they felt performing the assessments after each testing session. We hypothesize that     the weighted compression vest will improve fatigue and anxiety immediately and 24 hours after     performing a complex task, and will improve static and dynamic balance, gait variability, and     walking speed in patients with mTBI, during the tasks.   "
91812|NCT02084316|"     This study will evaluate the effects of a comprehensive approach (One4All) to increase the     percentage of patients that receive their HIV testing results and counseling.      Primary Hypothesis: The One4All approach will increase the proportion of individuals who have     completed all tests to confirm HIV diagnosis and received counseling within 30 days of     screening HIV+, given they have screened HIV+ on the initial test, from 40% to 60%.   "
91813|NCT02084303|"     The investigators plan to study inflammation in the brain (neuroinflammation) in human     patients with epilepsy using a novel, non-invasive technique that has been proven successful     in humans with other neuroinflammatory diseases. This technique uses ferumoxytol, a drug with     minimal side effects that is FDA-approved for the treatment of iron deficiency anemia, as the     contrast agent in magnetic resonance imaging (MRI). The study will recruit epilepsy patients     who are admitted to Dartmouth-Hitchcock Medical Center (DHMC) for     video-electroencephalography (video-EEG) monitoring in order to evaluate their candidacy for     curative brain surgery. During the hospital stay and after informed consent, the patient will     receive a standard-dose intravenous injection of ferumoxytol, and undergo one session of MRI     at 24-48 hours after the injection. The patient will also undergo a separate baseline MRI     session (if not already done at DHMC) at admission or at more than four weeks after the     injection but before any brain surgery. Brain regions that preferentially uptake ferumoxytol     are localized by subtracting the post-injection MRI session from the baseline MRI session.     The investigators will investigate whether these regions overlap with the epileptogenic     focus, namely the region that generates epilepsy and is localized by video-EEG and other     diagnostic measures. Lastly, for those patient participants who thereafter undergo brain     surgery, DHMC neuropathologists will use special stains to detect and quantify     neuroinflammation in brain tissue removed, and the results will serve as the reference for     the investigators to measure the sensitivity and specificity of ferumoxytol-based MRI in     detecting neuroinflammation.   "
91814|NCT02084290|"     Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on     patients' treatment choice, persistence with chosen therapy, decision quality, cost of care,     and outcomes      Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand     which treatments are right for them and will lead to a higher acceptance of appropriate     therapy, improved persistence with chosen therapy, lower costs and improved clinical     outcomes. To accomplish this aim, Investigators will perform a randomized controlled trial     to:        1. Determine how the shared decision making program influences patients' choice of therapy        2. Evaluate how the shared decision making program affects persistence with chosen therapy        3. Determine how the shared decision making program affects decision quality        4. Determine how the shared decision making program influences cost of care and clinical          outcomes      Expected Outcome and Impact: Investigators expect that this program will influence patients'     choice of therapy, persistence with their preferred therapy, and lead to improved clinical     outcomes. Investigators believe that this product can be successfully operationalized in the     clinic to establish a new paradigm of how providers can communicate personalized treatment     options to patients across a broad range of diseases.   "
91815|NCT02084277|"     The objective of this prospective study is to compare these two treatments (conventional     brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will     provide the better oral health related quality of life (OHRQoL) outcomes for patients during     the initial orthodontic treatment compared with pretreatment.   "
91817|NCT02084251|"     GLP-1 analogues have been widely used because of their unique advantages (no risk of     hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide     in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide     as API).To improve the patients compliance and reduce potential adverse events associated     with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once     weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be     studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in     healthy subjects will be studied in this randomized, controlled dose escalating trial.   "
91818|NCT02084238|"     This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic     lupus erythematosus.   "
91819|NCT02084225|"     The purpose of this study is to determine feasibility, perceived utility and sustainability     of training local providers in ultrasound guided regional anesthesia for acute pain     management in a limited-resource conflict setting.   "
91820|NCT02084212|"     The aim of this research is to assess current care by studying macular function using     microperimetry and by then comparing visual acuity results with OCT (Optical Coherence     Tomography) data.      The examinations performed are those usually done in the follow-up of epiretinal membrane     surgery, apart from microperimetry which is an examination of the central visual field.     Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months     and 6 months after the surgery. The consultation includes an assessment of visual acuity, a     fundus examination an SD-OCT of the retina. The present protocol will require no additional     visits. The microperimetry will be done in addition to the usual follow-up examinations after     ERM surgery.   "
93309|NCT02064725|"     This is an open label, multi-center, single arm phase II study. The study will investigate     the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of     patients with recurrent or persistent PrR-negative endometrial cancer.   "
91823|NCT02084173|"     With the aging of western societies in the coming years combined with increasing alcohol     consumption among elderly, the number of elderly with alcohol problems is expected to rise     considerably.      Elderly patients are often lonely; suffer from feelings of loss, fear to be a burden on their     children and on society, and feel powerless. On the surface their alcohol related problems     seem less severe that those of the middle-aged patients while in reality co-morbidity and     social issues complicate alcohol dependency.      Currently, no specific treatment tailored for alcohol use disorder among elderly is     available. Consequently they receive either no treatment, are given brief advising from the     general practitioner or are referred to treatment at specialized treatment institutions with     no specific treatment for elderly.      The investigators propose a study aimed at developing and testing an outpatient behavior     therapy program for alcohol use disorders for seniors (60 years and older), which - if     effective - can be easily implemented in routine care. Three centers from Denmark, Germany     and USA (New Mexico) will participate. All three centers have a long and extensive experience     with alcohol treatment and alcohol research. Patients fulfilling the DSM 5 criteria for     alcohol use disorder are eligible for the study.      After informed consent participants will be randomly assigned to either Motivational     Enhancement Therapy (MET), four sessions/one session per week or MET followed by Community     Re-enforcement Approach (CRA), eight sessions/one session per week - thus 12 weeks of     treatment in total. 50% will receive MET and 50% MET+CRA. Primary outcome is percentage of     patients with abstinence or controlled use (alcohol intake of equivalent blood alcohol     content equal to or less than 0.5‰.). A total of 1000 patients will be enrolled. Participants     will be assessed with a battery of international validated instruments measuring drinking     pattern as well as key elements of treatment.      Participants are assessed before initiation of treatment, at the end of MET treatment (four     weeks), at the end of MET+CRA treatment (12 weeks), at 6 months, and at 12 months.   "
91824|NCT02084160|"     The objectives of this study are:        -  To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic          decompensation events        -  To evaluate the relationship between liver Biopsy and clinical outcome and show that the          MBT has a better predictive ability of clinical outcome than liver biopsy.        -  To evaluate the ability of the MBT to predict each of the individual liver related          complications.   "
91825|NCT02084147|"     This randomized pilot clinical trial studies how well positron emission tomography     (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed     tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases.     PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar     to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known     whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer,     cardiac disease, or neurologic disease.   "
91826|NCT02084134|"     During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a     neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by     making a small hole in the back of the nose into the bottom of the skull. The surgeon is able     to see the pituitary and tumor with an endoscope and remove the tumor through the hole.      Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal     failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure,     and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about     the use of perioperative steroids in pituitary patients. Traditionally, all patients     undergoing pituitary surgery were given steroids before, during, and after surgery because of     the assumption that there would be some compromise in the amount of ACTH released by the     pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH     secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result,     there are some centers that routinely give perioperative steroids to all patients undergoing     pituitary surgery and there are some centers that do not routinely give perioperative     steroids. There are several retrospective and prospective studies that have addressed this     issue and have shown that withholding perioperative steroids is safe, but there has never     been a prospective study comparing the two approaches.      Objectives: The goal of this study is to prospectively compare two approaches to the     perioperative management of patients undergoing transsphenoidal resection of a pituitary     tumor or cyst. One protocol includes the routine use of perioperative steroids and the other     does not. The investigators hypothesis, based on previous studies, is that patients who are     adrenally sufficient do not routinely need to be treated with perioperative steroids. The     investigators also hypothesize that the use of perioperative steroids may be associated with     a higher rate of adverse outcomes   "
91827|NCT02084121|"     A subject was treated under compassionate use provisions under this study with facilitating     cell therapy (FCRx) product manufactured using the CliniMACS (Miltenyi Biotec) device, rather     than the Max Sep (Baxter) device.   "
91851|NCT02083809|"     Currently, there is very little research to identify ways to decrease blood loss during D&E     (dilation and evacuation) procedures. The objective is to determine whether routine use of     intravenous oxytocin will improve bleeding outcomes at the time of D&E at 18-24-weeks     gestation. To evaluate the hypothesis, investigators will perform a randomized,     double-blinded, placebo-controlled trial. The patient will be followed until discharged from     the postoperative care unit during which time patient satisfaction, pain score and     postoperative bleeding will be assessed.   "
91828|NCT02084108|"     Introduction: Care of frail and dependent elders with multiple chronic conditions is a major     challenge for health care systems. The objective of this study is to evaluate the effect of     coordinating the existing structures in the private and public sector for the care of frail     and dependent persons over age 60, and susceptible of presenting complex bio-psycho-social     issues. This approach is aimed at improving the coordination, continuity, quality and     efficacy of care in this population, which presents a high risk of hospitalization, emergency     room visits, institutionalization and mortality.      Methods: Three-year cluster randomised controlled trial. A control group receiving usual care     (follow up by primary care physician and home nursing service) will be compared to an     intervention group that will be provided, in addition, in-home multidimensional geriatric     assessment with access to a 24h/7 day a week call service, and coordinated long-term     follow-up. Survival analyses will be conducted to compare the outcomes between groups.      Primary outcome:      - Hospitalizations: rates of first hospitalization, number, cause and length of stay.      Secondary outcomes:        -  Emergency room visits: rates of first visit, number and cause        -  Institutionalization: number of patients        -  Mortality: rate and number of deaths and place of death (home versus hospital)   "
91829|NCT02084095|"     Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance     (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I)     correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly     reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS     is independent of acromegaly intensity.      The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but is     just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through     free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.      Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF     binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test     acording to Bergman model. FFA will be directly measured in plasma.   "
91830|NCT02084082|"     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose     combination (FDC) tablet containing linagliptin and metformin extended release compared to     the free combination of linagliptin and metformin extended release, both under fed and fasted     conditions.   "
91835|NCT02084017|"     The purpose of this study is to investigate the current standard of wound care following     vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and     the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood     flow to the lower limb(s).      Negative pressure wound therapy consists of a closed, sealed system that produces negative     pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is     sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is     maintained by connecting suction tubes to a vacuum pump and waste collector.      The investigators objectives are to determine whether there will be any reduction in surgical     site infection and this potential reduction will influence length of hospital stay, emergency     room visits, antibiotic use and need for re-operation.   "
91836|NCT02084004|"     The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride     and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the     potential mechanism.   "
91837|NCT02083991|"     Balancing immunosuppressive treatment in organ transplantation in order to achieve effective     prevention of rejection on one side and avoidance of negative side effects on the other side     is a major challenge, leading to developing different immunosuppressive protocols.     Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin     Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular     morbidity, nephrotoxicity and malignancies.      The investigators believe that both avoidance of CS and minimization of CNI, while using     Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and     mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side     effects, without increased rejection frequency in renal transplanted patients.   "
91838|NCT02083978|"     In this proposal, the investigators will focus on subcortical gray and white matter     structures commonly found to be abnormal in schizophrenia. Thus, the investigators will     evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as     measures of structural integrity of the corpus callosum and its various subregions.   "
91839|NCT02083965|"     The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc     administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The     secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK     assessment for up to 6 months for a continued treatment period.   "
91840|NCT02083952|"     Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born     prematurely, and has been associated with a wide range of symptoms. These include     irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung     disease, and delays in growth and development. A novel approach to the mangement of GERD in     infants is the use of an abdominal band, applying gentle pressure and possibly reducing the     reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a     swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia,     oxygen declines, and pH (acid) changes.   "
91842|NCT02083926|"     -  Social Anxiety Disorder (SAD) is common and causes significant impairment.        -  First-line treatments for Social Anxiety Disorder are only partially effective. Many SAD          patients experience little or inadequate symptom relief with available treatments.        -  Ketamine is a potent NMDA receptor antagonist. Ketamine represents an agent with a          potentially novel mechanism of action for the treatment of anxiety disorders.        -  Ketamine has demonstrated efficacy in the treatment of psychiatric disorders closely          related to Social Anxiety Disorder including Major Depression, Bipolar Depression and          possibly Obsessive-Compulsive Disorder.      Ketamine represents the possibility to provide rapid symptom relief to patients with SAD and     may provide the mechanism for future drug development to treat SAD more rapidly and     effectively.   "
91843|NCT02083913|"     The aim of our study is to evaluate the feasibility of a supervised training session using     telehealth in the Clinique medico-chirurgicale du traitement de l'obésité de Sherbrooke     (CMCTO) and its impact on health, physical fitness, quality of life and satisfaction of     subjects. 6 subjects awaiting bariatric surgery will be recruited. In addition to usual care,     subjects will perform additional sessions of supervised endurance and resistance exercise     training. Subjects will be instructed to perform two supervised exercise sessions per week     with telehealth plus one without supervision during 12 weeks. The following outcomes will be     assessed before and after the telePreSET, then 12 months after bariatric surgery: 1- physical     fitness (6MWT, maximal strength, symptom-limited cardiac exercise test); 2-health related     quality of life (Laval questionnaire); 3-weight, height, body composition (bioelectrical     impedance scale); 4-comorbidities and metabolic parameters (files and blood samples);     5-exercise beliefs (Physical Exercise Belief questionnaire); 6-physical activity     (GPAQuestionnaire and actimeter). The feasibility will be assessed with a satisfaction     questionnaire concerning physical activity management, dropout and compliance rates, as well     as the number of injuries and accidents. The results of this research will give us     preliminary data for future projects in order to improve support of bariatric surgery     candidates to assure optimal results for their health. Also, we will contribute to the     advancement of scientific knowledge, absent in the current literature in this population.   "
91844|NCT02083900|"     Prospective Randomized double-blind controlled trial comparing the healing rate, infection     rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid     dressing.   "
91845|NCT02083887|"     Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a     safe and effective vaccination strategy against malaria. The vaccines have been found to be     well tolerated when tested in Gambian adults, young children and infants, who are at risk of     severe malaria. Both vaccines will be given to participating infants at the same time as some     EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still     helpful in making the body's defense system respond.   "
91846|NCT02083874|"     Single subject repeated measures design of an open label administration of Cannabidiol (CBD)     to 5 participants withdrawing from cannabis use in an inpatient setting. 300mg of CBD will be     administered once on day 1, twice on days 2-5 and once on day 6. Participants will be     discharged on day 7. CBD will be administered orally in capsules.   "
91847|NCT02083861|"     The purpose of this study is to measure the effectiveness of a wearable therapeutic     ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of     the device to reduce pain, increase mobility, increase range of motion and muscle strength of     the affected leg, and improve quality of life in patients with knee osteoarthritis will be     evaluated.      While the use of ultrasound to treat pain is established in the field, the ability to deliver     low intensity, therapeutic ultrasound on a daily basis is new. The use of a wearable     ultrasound device to deliver daily, low intensity, long duration ultrasound has been approved     by the FDA for pain relief, relief of joint contracture, relief of muscle spasm, and     increased circulation; however, it is not yet indicated for relief of knee osteoarthritis.     The interventional device in this study is self-applied by the patient and worn daily for 4     hours of continuous therapy.   "
91848|NCT02083848|"     Background of the study: The accurate assessment of local cervical cancer spread (i.e.     invasion) is of clinical importance for staging and treatment considerations. For example, if     parametrial invasion is absent, radical surgery is the treatment of choice for tumors less     than 4cm in diameter. However, if such invasion is present, the patient has become inoperable     and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part of staging     work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to relatively     frequent false-negative findings a risk of understaging and under-treatment occurs. For such     cases adjuvant treatments with (chemo)radiotherapy are indicated after the initial surgery,     causing increased morbidity and treatment associated risks. For higher stages, with primary     (chemo)radiotherapy, a more reliable MRI based delineation of local tumor spread could enable     individualized dose(volume) and field modifications.      Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI     sequences, which use a combination of an endorectal and external coil, to image the     (para)cervical area for assessment of the loco-regional tumor status in cervical cancer.      Study design: The proposed study is an investigator initiated, single center, prospective     pilotstudy.      Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA of     IIB will be included.      Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI     sequences of the (para)cervical area which allow qualitative assessment of the loco-regional     invasion of cervical cancer.   "
91849|NCT02083835|"     PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing     and analysing clinical and patient-reported outcome data of postoperative pain.   "
91850|NCT02083822|"     The survival of premature babies increased during the last decades. However, the     neurocognitive long term development of these children is worrying, as demonstrated by     EPIPAGE 1 study.      These children present high risk of deficits such as cognitive deficits, adaptive     malfunction, behavior disorders and difficulties in school learning.      Understanding the specific neuropsychological disorders at the origin of these deficits is an     important objective. Studies realized at school age showed that many premature children have     executive functions (EF) disorders. However the specific nature of these disorders and the     neuropathology associated are unknown.      The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA     and to correlate MRI findings with executives functions and neurodevelopmental outcome   "
91852|NCT02083796|"     The hypothesis of this study is that thoracic spine manipulation would reduce pain in     subjects with SIS and cause changes in scapular kinematics and muscle activity in subjects     with impingement symptoms and in asymptomatic subjects. With this study, the investigators     want to answer if possible changes in scapular motion and muscle activity following a TSM     depend on the symptoms or if it is generic to individuals without shoulder dysfunction and     not specific to subjects with shoulder impingement.   "
91853|NCT02083783|"     The purpose of this study is to determine whether TRI102 is effective in the treatment of     Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.   "
91854|NCT02083770|"     Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study     is to develop and test programs designed to reduce barriers and increase facilitators     associated with cancer clinical trials participation for Hispanic Americans.   "
91855|NCT02083757|"     Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous     partial pressure of oxygen (PtcO2) in the critically ill patients.   "
91856|NCT02083744|"     The long-term goal of this research is to determine whether a psychoeducational intervention     will support self-care behaviors in Hispanic patients with heart failure. The specific goal     of this study is to determine whether a culturally-appropriate psychoeducational intervention     in Hispanic patients with heart failure, compared to a control group, will improve heart     failure knowledge and self-care behaviors.      We hypothesize that patients who receive the intervention will have improved heart failure     self-care behaviors and depression scores as measured by the Self-Care Heart Failure Index     and Patient Health Questionnaire.   "
91857|NCT02083731|"     The purpose of this study is to evaluate the efficacy of mesenchymal stem cells (MSC) in the     treatment of refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem     cell transplantation (allo-HSCT).   "
91858|NCT02083718|"     The purpose of this study is to evaluate the utility of treating patients experiencing poor     graft function after allogeneic hematopoietic stem cell transplantation with Granulocyte     Colony-Stimulating Factor (G-CSF) mobilized peripheral stem cell combined (PBSC) with     ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first     objective was to evaluate the effect of such treatment on poor graft function, and second     object was to investigate the safety of such treatment.   "
91859|NCT02083705|"     Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual     inflations (3:1) per minute in newborns. The study aimed to determine if CC s during     sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated     3:1 resuscitation.   "
91860|NCT02083692|"     The purpose of this study is to assess the effect of metformin in tumor metabolism in     patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20     expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.   "
93728|NCT02059265|"     This phase II trial studies how well dasatinib works in treating patients with ovarian,     fallopian tube, endometrial, or peritoneal cancer that has come back or is persistent.     Dasatinib may shrink patients' tumors by blocking some of the enzymes needed for cell growth.   "
91861|NCT02083679|"     This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in     combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung     Cancer (NSCLC).      The sponsor decided to discontinue the development of Sym004. Also the decision was made to     discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004     in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of     the early discontinuation of the trial during the dose escalation part, the expansion cohort     will no longer be performed hence the pre-specified secondary endpoints are not analyzed and     were removed from the protocol based on protocol amendment 2 dated 31 March 2015.   "
91862|NCT02083666|"     The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy     volunteers following single and repeated administration.   "
91863|NCT02083653|"     This is a Phase 2, open-label, 3-arm trial of two Sym004 doses (Arms A and B) and a control     group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to     anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).   "
91864|NCT02083640|"     This study is to assess the relative bioavailability of palbociclib hard gelatin capsule     formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule     formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard     gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg     oral doses under fed conditions in healthy volunteers.   "
91865|NCT02083627|"     This study will assess the effect of multiple doses of fidaxomicin on the single dose     pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and     tolerability of multiple doses of fidaxomicin in the presence of a single dose of     rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses     of fidaxomicin and its metabolite OP-1118.   "
91866|NCT02083614|"     The effect of clamping the indwelling urethral catheter before removal is an unsettled issue     in clinical practice. No studies have done before in the patients with gynecologic cancers     who received radical hysterectomy. We hypothesized that clamping the catheter would decrease     the rate of recatheterization. In addition, the feeling of urination during clamping is     correlated with lower rate of recatheterization after removal.   "
91867|NCT02083601|"     The current study will implement and evaluate a multi-component, psychoeducational     intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. Two     hypotheses will be tested. First, caregivers who participate in the intervention group will     demonstrate better outcomes than caregivers in the control group. Second, children with SCI     whose caregivers participate in the intervention group will demonstrate better outcomes than     children with SCI whose caregivers participate in the control group.   "
91868|NCT02083588|"     Fibromyalgia Syndrome (FMS) is a highly prevalent condition often affecting individuals in     the prime of life, causing severe reduction in quality of life and productivity, as well as     social isolation, anxiety, and depression. The purpose of this study is to explore the     efficacy of H1 deep TMS for the treatment of FMS patients. In addition, the investigators     attempt to assess the effect of dTMS on the perception and modulation of pain in patients     suffering from FMS.   "
91869|NCT02083575|"     role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.   "
91870|NCT02083562|"     The purpose of this study is to assess the association of biomarkers on day 7 of life with     the development of bronchopulmonary dysplasia in very preterm infants. Additionally a short     lung function test at 36 weeks postmenstrual age (PMA) will be performed to investigate     whether certain capnographic indices are able to reflect the degree of lung disease.      Protocol was amended (under others: additional enrollment of 70 subjects).   "
91871|NCT02083549|"     The purpose of the study is to evaluate the efficacy of the University of Rochester Medical     Center's current Massive Transfusion Protocol.      Upon arrival of trauma level one designated patients the treating team evaluates the     patient's injuries. If the patient is initiated under the facilities Massive Transfusion     Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the     study. Study procedures include collection of a blood sample following the transfusion of     each shipment, through shipment 5, of blood products outlined in the current Massive     Transfusion Protocol.      Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic     state through resuscitation. One final blood sample will be collected 24 hours following the     discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.      Due to the critical need for medical intervention, consent procedure will be waived at time     of enrollment. An authorized representative for the patient will be identified and approached     to obtain consent for use of data collected.   "
91872|NCT02083536|"     The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and     determine the recommended phase II dose of combining the effect of LDFWART following     administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant     ovarian cancer.   "
91873|NCT02083523|"     This study will use a pilot test format to examine the efficacy of a brief Motivational     Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE     (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance     abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.   "
91874|NCT02083510|"     The aim of this trial will be to determine an effect-size for the administration of chronic     low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density     lipoproteins (VLDL), and apolipoprotein CIII (apoCIII) in human subjects over a period of 4-6     weeks.   "
91875|NCT02083497|"     To evaluate the influence of different types of ankle taping in dynamic equilibrium and the     electrical activity of the support member during the sporting gesture kicking muscles.   "
91939|NCT02082639|"     The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK     Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV     vaccine according to 0, 6 month schedule, compared to the administration of either of these     vaccines alone. The study will ascertain that the immune responses elicited to the two     vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV     vaccine are administered alone.   "
91876|NCT02083484|"     This is an expanded access program (EAP) for participants who have progressed after prior     systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1     (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated.     Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475)     clinical trial with the exception of a participant enrolled in the pembrolizumab protocol     MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such     participants will be eligible to participate in the EAP, regardless of prior treatment with a     BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.   "
91877|NCT02083471|"     Egg, milk and cereal allergies are the most important food allergies in Finnish children, the     prevalence in western countries is 1-4 %. In some individuals food-allergy is maintained in     to adulthood. Recent studies suggest that specific oral tolerance induction (SOTI) provides a     treatment option in children with continuing allergy with high success rates. The study aims     at specific oral tolerance induction in adults allergic to cow's milk or hen's egg. Oral     immunotherapy involves taking very small amounts of the allergen, and slowly increasing the     amount. Consequently, an elimination diet may be wholly or partially cancelled, without the     fear of serious allergic reactions. Another aim is to explore changes in antibody-mediated     and cell-mediated immune response to individual components of cow's milk and egg allergens     during tolerance induction and compare these with the effect of the treatment.   "
91878|NCT02083458|"     The central line placement is the widespread procedure performed in the intensive care and     emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters,     administration some medications, renal replacement therapy, parenteral nutrition and     hemodynamic monitoring.      The procedure is performed by percutaneous puncture of large vein of the neck and the thorax     - internal jugular vein or subclavian vein, then insertion of guidewire through the needle     and placement of the catheter over the guidewire. The tip of the catheter is situated in the     superior vena cava.      There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most     frequently cannulated veins in landmark-based approach are internal jugular and subclavian     vein. The cannulation of the axillary vein is not common procedure in the intensive care     unit, mainly due its complicated original technique.      The primary intention of this study was to describe and assess usefulness and safety of the     new landmark-based technique of catheterization of the axillary vein in patients admitted to     the intensive care unit.   "
91879|NCT02083445|"     Circulating progenitor cells (CPC) treatments may have great potential for the recovery of     neurons and brain function. Our group has reported how exposure to intermittent hypobaric     hypoxia with superficial muscle electrostimulation is able to increase the concentration of     CPC in peripheral blood in humans. Therefore, we believe that through physical activities and     exposure to intermittent hypobaric hypoxia for a period, it will increase CPC in the blood of     subjects who have suffered a severe Traumatic Brain Injury (TBI) one or more years ago,     promoting regeneration and functional and cognitive recovery. The study primary end-point is     to improve physical or psychological functioning of participants with TBI with a program of     exercise, muscle electro-stimulation (ME) and/or intermittent-hypobaric-hypoxia (IHH).     Secondary end-points are to increase and maintain CPC and also to study their possible     relationship with physical or psychological improvement of participants with Traumatic Brain     Injury (TBI). In order to achieve these objectives investigators have designed a randomized     controlled trial that will include those patients who suffered severe TBI more than one year     previously with physical or psychological sequelae. Exercise, muscle electro-stimulation (ME)     and/or intermittent hypobaric hypoxia (IHH) programs will be applied during twelve weeks.     Psychological and physical stress tests will carry out before and after the program and CPC     will measure at the beginning, every two weeks, and at the end of the program.   "
91880|NCT02083432|"     The aims of the study: to explore the possible effectiveness of cognitive behavior treatment     (CBT) among children and adolescents with formally diagnosed intra-oral injection phobia     (DSM-IV), when performed by specially trained dentists.      The patients diagnosed with intra-oral injection phobia according to the diagnostic manual     DSM-IV. The effect of cognitive behavior therapy when performed by specially trained dentists     will be evaluated. Patients referred to the Centre for Odontophobia, and who meet the     inclusion criteria, will be allocated to an immediate treatment group (test group) and a     waiting list group (control group) of 30 subjects in each group. After treatment they will be     followed up during a 1-year period.      Hypotheses are formulated based on the literature and previous population and treatment     studies of similar designs among adults at the Centre for Odontophobia.   "
91881|NCT02083419|"     Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for     heart failure and those suffering from arrhythmias. The purpose of this research study is to     determine the effect left-ventricular pacing has on patients who have a ventricular assist     device.   "
91882|NCT02083406|"     A single dose study to investigate how different formulations of OZ439 co-administered with     PQP tablest are processed by the body when taken without food   "
91883|NCT02083393|"     To observe changes of circulating and tissue dendritic cells in acute lung injury,including     invasive aspergillosis pneumonia   "
91884|NCT02083380|"     A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability     and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients     > 0.5 years and <= 70 years of age with uncomplicated Plasmodium falciparum malaria in Africa     and Asia (Vietnam).      Interim analyses for futility were planned. Adults and children will be included through     progressive step-down in age following safety review by an independent safety monitoring     board (ISMB).      If the study were to meets its efficacy objectives, this will inform dose setting for Phase     III studies.   "
91885|NCT02083367|"     Investigating the impact of hepatic encephalopathy on default mode networks within the brain     to provide more clues with understanding the physiology of consciousness and predicting the     reversibility of comatose states.   "
92265|NCT02078401|"     The goal of this project is to get more insight into the (neuro)ophthalmological     characteristics of children with neurofibromatosis type 1. This way investigators would like     to update the current guidelines for follow up and treatment of optic pathway gliomas.     Clinical findings will be compared with the results of Optical coherence tomography (OCT) and     MRI (magnetic resonance imaging).   "
91886|NCT02083354|"     This is a single-arm, open-label, multi-center, Phase II study to evaluate dabrafenib and     trametinib combination therapy in subjects with BRAF V600 mutation-positive, unresectable or     metastatic Acral lentiginous or cutaneous melanoma. This study will evaluate the objective     response rate (ORR), progression free survival (PFS), duration of response, overall survival     (OS), safety and efficacy, to assess steady state (all subjects) exposure to dabrafenib,     dabrafenib metabolites, and trametinib and characterize the population pharmacokinetics (PK)     and pharmacodynamics (PD) of dabrafenib and trametinib. Subjects will be enrolled and will     receive dabrafenib 150 milligram (mg) orally twice daily and trametinib 2 mg orally once     daily. Treatment will continue until disease progression, death, unacceptable toxicity, or     withdrawal of consent, or study closure. After treatment discontinuation, subjects will be     followed for survival and disease progression as applicable.   "
91887|NCT02083341|"     Muscle tension dysphonia (MTD) is a disabling voice disorder which causes severe voice     change, neck pain, and voice fatigue. Current therapy modalities to treat these disorders     include multiple visits to a qualified speech language pathologist (SLP) for rehabilitation     with voice exercises and focused laryngeal/neck massage. Access to these services is     difficult with long waitlists and often not covered by current public health insurance or     locally available to many patients in Ontario. The goal of this study is to demonstrate a     reduction in symptoms and improvement in vocal function by applying an external vibration     device to key sites (e.g. jaw, neck, skull base) commonly identified as a source of abnormal     muscle tension and injury in certain voice disorders, specifically MTD.      This study will also investigate the effect of external vibration on the voice quality in     classically trained singers (CTSs). Certain desirable acoustic qualities in a singers' voice     are only accessible when the larynx and its extrinsic muscles are in a relaxed state. Muscle     misuse and vocal strain are common problems in performers, which can result in conditions     that require surgery and speech therapy, and may lead to a loss of income. Similar to vocal     warm up exercises which contribute to the prevention of vocal injury, external vibration is     expected to improve muscle perfusion in an acute setting and may have a direct effect on     vocal fold cover viscosity.      Both study groups will be randomized to receive either the external vibration device or a     sham device. The sham device looks identical to the experimental device but has the vibration     component removed.   "
91888|NCT02083328|"     The aim is to investigate the influence of caffeine on heart rate variability and on     performance in a 3 min exercise test in different population groups (able-bodied, paraplegic     and tetraplegic subjects).      In general, the investigators are interested in the differences between the heart rate     variability before and after caffeine supplementation and if the subjects exercise     performance is enhanced using this type of supplementation. Another objective is to see     whether there are differences between able-bodied and disabled subjects.      Tetraplegic subjects showed in some previous studies no Low-Frequency-component (LF) for     heart rate variability and no increase in catecholamines after the ingestion of caffeine.     Therefore the investigators think, that tetraplegic subjects won`t show any ergogenic effect     in exercise performance after the intake of caffeine. On the other hand, paraplegic subjects     should show similar differences of heart rate variability after the ingestion of caffeine as     able-bodied subjects. Paraplegic subjects should benefit from caffeine supplementation in an     increase in exercise performance.   "
91889|NCT02083315|"     This study is designed to compare TRV130 to placebo and morphine to learn about its effects     on pain relief and side effects.   "
91890|NCT02083302|"     The purpose of this study was to examine the impact of a bystander intervention education     program on college students' attitudes and behaviors associated with bystander intervention     and sexual violence.   "
91891|NCT02083289|"     The primary objectives of this study are to compare the safety, tolerability, and mean change     from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to     latanoprost 0.005% following ocular instillation once every evening for 28 days.   "
91924|NCT02082834|"     The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient     with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based     iterative reconstruction (MBIR- VEO TM).   "
91925|NCT02082821|"     Heart transplantation is a lifesaving procedure for patients with end-stage heart failure and     provides a better survival and quality of life as compared to conventional medical or     pharmacological treatment. Transplanted hearts are subject to the effects of the alloimmune     response, which if left uncontrolled is capable of jeopardizing long-term cardiac function.     Recently, advances in immunosuppression have enhanced the survival of transplanted patients.     Nearly 2500 cardiac transplants per year have been performed in the US during the last 10     years and despite significant improvements, long-term cardiac allograft survival rates remain     poor. More than 20% of patients do not survive beyond 3 years, and those who do survive are     afflicted with the long-term complications associated with chronic immunosuppression. Life     expectancy of patients who lose cardiac allografts is dramatically poor due to the absence of     any therapeutic tool apart from re-transplantation, which is plagued by poor outcomes. The     identification of novel therapeutic targets is thus mandatory. ATP/P2X7R signaling in T cells     is highly relevant for cardiac allograft survival. ATP is a small molecule present at high     concentrations inside cells and released as extracellular ATP (eATP) following cell damage or     death, which is abundant at inflammation sites and acts as a danger signal constituting an     alerting system. ATP is sensed by the ionotropic purinergic P2X receptors (seven receptors     named P2X1-7) expressed mainly, but not exclusively, by T lymphocytes, thereby regulating T     cell activation. We have recently demonstrated that the ATP/P2X7R axis has a key role in     cardiac allograft survival in humans and mice. Cardiac allograft vasculopathy (CAV) is a     major limiting factor for cardiac allograft survival. One of the major limiting factors for     cardiac transplantation is CAV, which develops frequently in heart transplant recipients. CAV     results in allograft failure, and it occurs in 50% of cardiac transplant recipients by 5     years after transplantation, as shown by angiography or intravascular ultrasound examination.     CAV is clearly of immunological origin, as syngeneic murine grafts do not develop CAV. Once     CAV occurs, the most definitive treatment is re-transplantation, but survival is limited due     to the fact that pharmacological management only somewhat attenuates the process. We     hypothesize that a single nucleotide polymorphysm (SNP) loss-of-function P2X7R mutation     (p.Glu496Ala / c.1513A>C, rs3751143) generates a compensatory upregulation of the other     purinergic receptors (P2XsR), thus creating a state of hypersensitivity to eATP. This eATP     hypersensitivity results in an abnormal generation of Th1/Th17 cells, that leads to CAV and     early cardiac allograft loss. Our study will answer a fundamental question: What is the     effect of the P2X7R loss-of-function mutation on the immune system? Our expertise in studying     the ATP/P2X7R axis has been recently recognized in two publications and we are now ready to     test our novel hypothesis on the P2X7R loss-of-function mutation. Our goal is to generate the     first targeted-therapy for a selected group of cardiac transplant recipients.   "
91892|NCT02083276|"     The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis     infection has been macrolide antibiotics in the form of azithromycin, and alternatively     tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a     single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg     doxycycline a day. However, recent studies have reported increasing treatment failure that     may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is     evolving. Research regarding other bacterial species indicates a high frequency of mutation     based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma     genitalium infections. There has only been case reports of tetracycline resistance among     human Chlamydia isolates, but a recent study suggest that there might be decreasing     effectiveness also for doxycycline. Veterinaries has for several years observed increasing     prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population     there is promiscuous horizontal gene transfer.      If the current trend of declining cure rates continues, the investigators might face a     situation where there are no documented and effective treatments for Chlamydia trachomatis     infections. This underline an urgent need to expand the number of documented treatment     options and mecillinam seems to be one of the options that warrant further investigation.      The objectives of this study is to prove the concept of treating genital Chlamydia     trachomatis with mecillinam (Pivmecillinamhydrochlorid).   "
91893|NCT02083263|"     With the use of Non invasive ventilation the patients with cystic fibrosis will have better     lung function (FEV1).   "
91894|NCT02083250|"     The goal of this clinical research study is to evaluate the safety of combining vorinostat     (also called SAHA) with fludarabine, clofarabine, and busulfan.   "
91940|NCT02082626|"     This is a study for children with cancer with no curative treatment options. The     investigators will be giving eribulin, a new chemotherapy agent, for the first time to     children. This study is designed to determine a safe dose the investigators can give to     children in larger studies. The investigators will be monitoring the children on this study     for the safety of the treatment and levels of eribulin in the blood after treatment. The     investigators will also study the effect of the agent on the cancer.   "
91895|NCT02083237|"     Mild cognitive impairment (MCI) is a significant risk factor for dementia. Persons with MCI     experience cognitive changes, most typically affecting memory; that are greater than those     experienced in normal aging. However, these cognitive changes in MCI, unlike in dementia,     are not significant enough to markedly interfere with functional independence. In addition to     cognitive change, some people with MCI also experience elevated symptoms of depression and     anxiety, which adds to their risk of developing dementia. Close family are also impacted by     their relative's MCI and show mild physical (e.g., increased incidence of systemic health     problems such as high blood pressure) and mental health declines (e.g., elevated symptoms     associated with depression and anxiety) that are similar, though not as severe, to those     experienced by caregivers of a relative with dementia. Programs aimed at behavioural     intervention have real potential to reduce and/or prevent negative health outcomes associated     with MCI and future dementia by promoting positive behaviour changes. We wish to     scientifically establish the utility of a behavioural intervention aimed at addressing the     needs of both the person with MCI and their close family member, with the ultimate goal of     lowering current and future susceptibility to mental health declines and chronic disease in     people living with MCI. We have an 8 session (16 hour) program, where participants with MCI     and their close relative are together for the first half of each session, which is devoted     primarily to enabling positive lifestyle choice. In the second hour the group splits up, with     MCI clients engaging in memory training while their close family member participates in a     psychosocial intervention.   "
91896|NCT02083224|"     Clinical cancer genetics is an emerging new field in medical oncology, and has been     incorporated into routine oncology practice in many leading medical institutions in North     America and Europe. Cancer genetics is the study of genetic factors contributing to     carcinogenesis. In the last 5-10 years, genes responsible for various well-defined hereditary     cancer syndromes have been cloned. These include the BRCAJ/2 genes in hereditary breast and     ovarian cancer syndrome, the A4PC gene in Familial Adenomatous Polyposis, and the mismatch     repair genes (hMLH1, hMSH2, hPMS1, hPMS2, hMSH6) in hereditary non-polyposis colorectal     cancer (HNPCC). One of the goals of a clinical cancer genetics service is to identify     families at risk for hereditary cancer syndromes, provide genetic counseling, and offer     genetic testing when appropriate. The identification of causative genes in hereditary cancer     syndromes together with the advent of genetic testing is starting to have an impact on     clinical management. The ability to identify a gene mutation in a cancer family allows     predictive testing, stratifying at-risk family members into carriers who will benefit from     aggressive surveillance and/or preventive options, and non-carriers who may be spared     unnecessary surveillance. Appropriate use of genetic testing will ultimately result in     medical cost reduction.      The investigators hypothesize that the clinical characteristics and genetic factors     contributing to hereditary cancer in the Singaporean Asian population are distinct from those     described for Western patients.   "
91897|NCT02083211|"     This study evauates the global survival of patients following administration of mAb     Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy,     after relapsing from chemo-radiotherapy.      It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be     assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After     progression, a second line chemotherapy based on carboplatino/taxol will be administered in     both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until     limiting toxicity or ECOCG >3.      Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be     evaluated using MRI.   "
91898|NCT02083198|"     This observational study evaluates the impact of high and low chloride containing IV fluids     on administrative and clinical outcomes. The study uses a large electronic health dataset and     examines patients receiving fluid replacement and resuscitation. The hypothesis is that high     chloride solutions are associated with adverse outcomes as measured by administrative data     and by clinical parameters.   "
91899|NCT02083185|"     This is a 3-arm, randomized, open-label, parallel group study of TAK-385, together with a     leuprorelin observational cohort, in patients with prostate cancer who require first-line     androgen deprivation therapy (ADT).   "
91900|NCT02083172|"     The primary objective of this study is to evaluate the agreement between hemodynamic     measurements obtained using the Ultrasound Cardiac Output Monitor (USCOM®; USCOM Ltd.,     Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography     (2D-echo) measurements in a group of hemodynamically stable and unstable pediatric patients.   "
91901|NCT02083159|"     Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the     liver, which is one of the most common forms of chronic liver disease in developed countries.     In western countries, the prevalence of NAFLD in the general population is estimated to be     20-30%; in obese populations, this increases to 57.5-74%. But, it hasn`t been clearly     elucidated yet regarding the underlying disease pathophysiology and treatmet strategy.      Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been     reported to share structural homology with adiponectin. To date, 15 CTRP family members have     been found that might play major roles in glucose metabolism and inflammation.      The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean     men and women.   "
91902|NCT02083146|"     Now, adipose tissue is established as an active endocrine organ that controls systemic energy     homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis     factor-related protein (CTRP) family have been reported to share structural homology with     adiponectin. To date, 15 CTRP family members have been found that might play major roles in     metabolism and inflammation. The investigators tried to clarify the relationship between CTRP     family and coronary artery disease (CAD) in Korean men and women.   "
91903|NCT02083133|"     The purpose of this study is to assess whether the current recommendation for a 50% dose     reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or     on hemodialysis results in an increased number of hypoglycemic episodes.   "
91941|NCT02082613|"     This study will compare a minimal invasive operation in local anesthesia with sclerotherapy     for symptomatic testicular hydrocele within 6 months after randomization. Thirty days     complication rates will be assessed. The hypothesis is that surgery will lead to faster cure     while sclerotherapy would be cheaper and have less complications.   "
91904|NCT02083120|"     The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive     hypercapnic respiratory failure are still not sufficiently known yet.      The aim of this study is a step-by-step generation of physiological data about gas exchange     and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to     provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise     capacity, quality of life and gas exchange in a long term home treatment compared to a     standard low flow long term oxygen therapy (LOT).      Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous     carbon dioxide partial pressure (PCO2) after four weeks of treatment.   "
91905|NCT02083107|"     The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1     synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol     before caesarean section to decrease blood loss during and after the operation.   "
91906|NCT02083081|"     In the southwest region of Alaska where the project takes place, 79% of Alaska Native women     smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy     appears to be a high risk period for initiation of tobacco use, primarily ST, among women     reporting no use of tobacco 3 months before pregnancy. Intervention efforts targeting the     entire community, not only pregnant women, to address social norms about tobacco use may be     effective. Thus, the investigators will evaluate the efficacy of a novel, multi-component,     theory-based intervention for reducing tobacco use during pregnancy, incorporating both     individually targeted and community level components delivered by female elders Native     Sisters. The intervention builds on effective community and individual-based approaches for     tobacco cessation and lay health advisor approaches for cancer prevention among Native     American women. As part of the intervention, a social marketing campaign including digital     stories and other small media will be developed with community feedback. Individually     targeted components will be six 30-40 minute telephone or home-based peer counseling sessions     with pregnant women.   "
91907|NCT02083068|"     This is a randomized, double-blind, controlled, which seeks to compare two groups of     volunteers (naive and previously exposed to malaria) who were made 3 immunizations with a     synthetic derivative of the CS protein of Plasmodium vivax in order to determine their     protective efficacy. Then volunteers will be subject to an infectious challenge to assess the     infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus     mosquitoes.   "
91908|NCT02083055|"     The aim of this study was to evaluate the positive anesthetic properties such as reduce     intraoperative analgesic requirement, time to extubation and recovery, and early     postoperative pain of dexmedetomidine used as a hypotensive agent compared with     nitroglycerin.   "
91909|NCT02083042|"     This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to     assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a     protective cut-off value for CMV reactivations/disease in kidney transplant recipients.      Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to     assess the functionality of a network of clinically relevant CMV-reactive effector cells. It     is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated     immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific     CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.   "
91910|NCT02083029|"     The investigators' hypothesis is that dysregulation of autonomic function, as revealed during     a simulated dive reflex, may result in an attenuation of the heart rate response to a greater     degree in asthmatics who collapse during exacerbations of asthma than that seen in healthy     individuals and in asthmatics without a history of syncope. The investigators will test this     by assessing autonomic function through a dive reflex protocol.   "
91911|NCT02083016|"     Ultra-high density mapping with multielectrode catheter may improve slow conduction channels     identification in ventricular tachycardia substrate ablation procedures compared to     conventional point by point mapping.      This study compares the ability of both mapping catheters to detect slow conduction channels     in areas of myocardial scar and their utility to assess substrate modification after     ablation.   "
91912|NCT02083003|"     It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine)     potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors.     In animal studies, polyamine-free diet has shown antinociceptive properties. This research     aims at evaluating analgesic properties of polyamine-low diet after laparoscopic     cholecystectomy performed in an ambulatory setting.   "
91979|NCT02082119|"     To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy,     concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.      Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.      Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant     chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.   "
91913|NCT02082990|"     Brief Interventions (BIs) for risky drinkers are an effective tool in primary care. Lack of     time in daily practice has been identified as a barrier for the wide implementation of BI.     There is growing evidence that e-health tools such as web based BIs can be an efficient     alternative to standard face-to-face BIs and save time to general practitioners (GP).      The main aim of this study is to test non-inferiority of a web based BI for risky drinkers     against a traditional face to face BI delivered by a general practitioner. We have designed a     randomised controlled non-inferiority trial comparing both interventions, to be performed in     primary care health centres in Catalonia, Spain.      Adults attending in primary care centres and willing to participate, will be invited to fill     the short Alcohol Use Disorders Identification Test (AUDIT-C) in a specific website. Those     screening positive and who accept to share the baseline data with their GP will be invited to     an online assessment of their drinking and randomized to a standard BI with their GP or to     the online BI.      Follow-up assessment will be conducted online at months 3 and 12, using the full Alcohol Use     Disorder Identification Test (AUDIT) and the quality of life questionnaire (D5-EQD5). The     main outcome will be the proportion of risky drinkers according to the AUDIT. Assuming a 30%     reduction in the proportion of risky drinkers in the control group (classroom), allowing for     an overall attrition of 10% of patients in the trial and non-inferiority assessed against a     specified margin of 10%, it is estimated that 500 patients would be required in each group to     give the test a 90% power (1-β) to reject the null hypothesis.   "
91914|NCT02082977|"     This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose     (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be     conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL),     transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors     (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the     safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further     explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2     (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell     lymphoma (GCB-DLBCL), tFL and MM.   "
91915|NCT02082964|"     In this randomized controlled trial 48 students were randomly allocated in three groups SCIM,     Video training (VT) and control group(no training). They had a workshops based on NRP and     lasted 6 hours for each group. Before and after the workshops and one month later all     students participated in a 7 station OSCE..   "
91916|NCT02082951|"     The objective was to compare the frequency and intensity of symptoms of anxiety in patients     of preoperative cardiac surgery who received empathic behaviour from nurse or family or those     who received no specific type of empathic behaviour. This is a randomized clinical trial. The     sample consisted of 66 patients in preoperative of cardiac surgery, who were divided in three     groups: empathic behaviour by nurses, without specific empathic behaviour and by family.     Anxiety was assessed at two time points: before and after the intervention. The instrument     used was developed and validated, comprising 19 defining characteristics of the nursing     diagnosis anxiety. The hypothesis is that the group who received empathic behaviour from     nurse or family will reduce the anxiety.   "
91917|NCT02082938|"     The purpose of this study is to verify if the incorporation of a new brace, which assists in     gait rehabilitation, can contribute to the rehabilitation process for stroke patients.   "
91918|NCT02082925|"     In view of the multiple limitations and restrictions relative to CPET (technical, time,     physical…), determination of individualized training threshold from this evaluation is today     not possible for a lot of patients.      The aim of this study was to propose a new clinical tool from 6MWT for individualized     exercise training: the dyspnea threshold (DT6).   "
91919|NCT02082912|"     The purpose of this study is to focus on enhancing upper limb recovery in patients     post-stroke by using robotic-assisted therapy in combination with a drug to improve learning     new motor skills.   "
91920|NCT02082899|"     This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel,     Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment     of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC)     Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects     will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.   "
91921|NCT02082886|"     In this registry study the investigators will collect data about patients' disease,     treatment, and response to treatment to include in both our local and national databases.     These can then be used by investigators to answer questions about cytoreductive surgery/HIPEC     such as how well-tolerated or effective it is in specific populations.   "
91922|NCT02082873|"     This research is being conducted to determine if Neuroscience intensive care unit (ICU)     nurses are able to identify seizures by reviewing quantitative EEG (qEEG) that is running at     the bedside. QEEG is the application of mathematical and analytical techniques to analyze EEG     signals. Several hours of data can be displayed on a single screen in several graphical     panels. Routine evaluation of EEG data consists of manual inspection of each page of EEG data     by a trained neurophysiologist (a neuro ICU doctor) and can be quite time-consuming. In most     cases, this data can only be reviewed intermittently and interpretation is almost always     relayed to the primary clinical team after the seizures have occurred. Theoretically,qEEG     graphical displays can provide a simplified view of complex EEG data that could possibly be     used by non-neurophysiologists, such as Neuro ICU nurses. Our hypothesis is that Neuro ICU     nurses are able to accurately identify recurrent seizures in real-time.   "
91923|NCT02082860|"     This is a Phase I trial aimed to determine the safety of the investigational gene therapy     product (rAAV2/5-PBGD) for the treatment of Acute Intermittent Porphyria (AIP).      Up to eight patients fulfilling the eligibility criteria will participate in this     multicentre, open label, single dose, dose-ranging Phase I clinical trial.      The enrolled patients will be followed up to assess the safety profile of the investigational     gene therapy product and to establish the maximum therapeutic safe dose to be administered in     future confirmatory/pivotal clinical trial(s). In addition, the biological and clinical     response to the treatment with rAAV2/5-PBGD in AIP patients will be assessed.      A complete evaluation of the clinical (symptoms and quality of life assessment) and     laboratory (blood and urine) data will be performed.   "
91926|NCT02082808|"     This study is designed to estimate the two-way drug interaction between DCV and DTG as a drug     interaction between DTG and DCV is expected to be low and this study is to be performed as     confirmation. This will be a single-center, open-label, three-period, crossover study in     healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV     pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h     and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the     safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV     60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h   "
91927|NCT02082795|"     The investigators aim to perform a qualitative study to explore the views of women with a     breech presentation on their management in general, and the use of anaesthesia or analgesia     for ECV in particular.   "
91938|NCT02082652|"     Antiretroviral therapy (medicines used to treat HIV) can interact with hormonal     contraceptives which might decrease their effectiveness. The single-rod etonogestrel     contraceptive implant is being more commonly used in low- and middle-income countries because     if the ease of insertion and removal. Efavirenz and nevirapine are first-line HIV medicines     in Sub-Saharan Africa and this study will help determine an effective way to use these     medicines with the etonogestrel implant. The investigators hypothesize that women receiving     nevirapine- or efavirenz-based antiretroviral therapy will have lower etonogestrel levels in     their blood after six months of insertion as compared to women not taking antiretroviral     therapy.   "
91928|NCT02082782|"     Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method     for tumors not amenable for surgical resection or thermal ablation, due to vicinity near     vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are     applied to tumorous tissue. These pulses alter the existing transmembrane potential of the     cell membranes, and create 'nanopores', after which the cell dies through loss of     homeastasis.      The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the     treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for     resection or thermal ablation due to vicinity to vulnerable structures such as vessels and     bile ducts. Other objectives are safety, feasibility (technical success) and imaging     characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities     in dianosing local site recurrence (LSR) or residual disease (RD).      29 patients with histologically confirmed colorectal carcinoma who present with unresectable     and not thermally ablative CRLM< 3.5cm suitable for IRE will undergo percutaneous or open     irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious)     adverse events are registered. One day post-IRE MRI is performed to assess technical success.     Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize residual or     recurrent disease. Overall technique effectiveness is determined 1 year after treatment.      The investigators hypothesize that IRE for central CRLM will lead to good tumor control     without causing severe complications.   "
91929|NCT02082769|"     The purpose of this study is to compare febuxostat allopurinol in subjects with gout.   "
91930|NCT02082756|"     The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine     Hydrochloride on lowering glucose and delaying progress to diabetes in patients with     prediabetes and to detect the potential mechanism.   "
91931|NCT02082743|"     The purpose of this study is making use of school policy- recess outside classroom (ROC7-11)     for increasing the time spent outdoor during recess and encouraging children spent time     outdoor up to 11 hours in each week to investigate the vision change, myopia onset and     progression in these schoolchildren.   "
91932|NCT02082730|"     This study aims to improve on the delivery of treatment for people with Chronic Fatigue     Syndrome/Myalgic Encephalomyelitis (CFS/ME). People with CFS/ME have low energy. This     interferes with doing everyday activities and has a major impact on quality of life. Energy     management is a key aspect of treatment and involves patients building up their energy levels     gradually. Their health professional finds out how much energy the patient uses daily so they     can prescribe how much activity and rest is right for the patient. The prescription is     adjusted throughout treatment. Over time, the patient learns the best way to spend and     preserve energy. To begin treatment, patients record their activity levels on paper over a     few weeks. Records need to be accurate, but this is often difficult because of problems with     memory, concentration or low energy and pain.      We have recently developed a new technology called ASARM (Advanced Sleep Rest Activity and     Rest Management) that records activity levels electronically and checks whether they match     the activity prescription. The ASARM device is worn on the patient's wrist. It measures     sleep, activity and rest, and has an electronic diary (a smartphone app) for recording daily     activities. The health professional has remote access to the information and uses the app to     change the prescription. This study will investigate if ASARM is (i) acceptable to patients;     (ii) a good way to deliver Cognitive Behavioural therapy CBT treatment; (iii) able to improve     their symptoms. Patients and clinicians will gain experience of ASARM for a short time, and     we will analyse their data. Our findings will help us develop ASARM so that it can be used in     routine care of CFS/ME patients.   "
91933|NCT02082717|"     The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during     peripheral intravenous potassium chloride replacement therapy for adult patients in a     Medical/Surgical unit. Using a randomized controlled double blinded experimental study     design, patients who are 21 years or older are alert, awake, and oriented at the time of     enrollment and have been ordered peripheral intravenous potassium chloride replacement will     be recruited from one Medical/Surgical during the first 24-48 hours of their admission.   "
91934|NCT02082704|"     Investigators are conducting a randomized controlled trial to determine whether an online     team-based spaced education (SE) game can improve HbA1c levels among these patients with     diabetes (primary aim). Secondary aims include determining the impact of the game on     patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine (M/C)     ratio, ACE PPR, and ARB PPR.   "
91935|NCT02082691|"     Patient with advanced liver cancer (cancer that has spread to other parts of the body)     continues to receive the study drug (G-202) even though patient no longer meets the criteria     to be a part of the main treatment study. Patient's cancer responded well to receiving G-202     in the main study and will receive G-202 at the same dose given in the main study.   "
91936|NCT02082678|"     The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated     with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD).     The investigators will also use blood samples to determine if the genotype for the serotonin     transporter gene is associated with response to ondansetron.   "
92191|NCT02079363|"     The objectives of this project are to test whether alteration in DNA hypermethylation in     plasma is:        -  a diagnostic marker for pancreatic cancer        -  a prognostic marker for pancreatic cancer        -  a marker for recurrence of pancreatic cancer        -  changing during the course of chronic pancreatitis, with the purpose of finding patients          with high risk of developing pancreatic cancer   "
91937|NCT02082665|"     This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation     positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin     and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose of dabrafenib     150 mg), and Day 22 (during repeat dose dabrafenib 150 mg twice daily [BID]). Dabrafenib 150     mg BID will be administered from Day 8 to Day 23. Blood samples for PK analysis will be     obtained over 32 hours post-dose on Day 1, Day 8, and Day 22. The last dose of dabrafenib     will be taken in the morning of Day 23 and the last blood sample in the evening of Day 23.     Subjects will be considered to have completed the study once the 32 hour PK sample has been     collected on Day 23. Once they have completed the study, eligible subjects may have the     option to enter study BRF114144, an open-label roll-over study of dabrafenib (no follow-up     visit required) and continue receiving dabrafenib.   "
91942|NCT02082600|"     The aims of this study are examine the effects of sleep deprivation in muscle recovery after     a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24     series of 10 repetitions). The sample will consist of 10 men, sedentary, clinically healthy,     aged between 20 and 31 years old. Two experimental groups will be developed: EXE-SLEEP, in     which subjects will perform the exercise protocol (~18:00-19:00) and will be subject to     normal period of sleep for 3 nights; EXE-TOTAL, in which subjects will perform the same     exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep     rebound.   "
91943|NCT02082587|"     As treatments improve and patients live longer with cancer, even after it has spread to the     brain, efforts to improve quality of life are growing. Neurocognitive function (thinking     ability and memory) is an area of particular concern for patients with brain metastases     (cancer that can spread to the brain). Although there are established tests to measure     neurocognitive function, these require a face-to-face assessment and can take a long time to     complete. As a result, efforts to use these tests to measure changes in neurocognitive     function in patients following treatment for brain metastases have resulted in a large     proportion of patients who do not return for follow-up. This has limited the ability to     evaluate the impact of current treatments on neurocognitive function. This study aims to     evaluate a shorter, telephone-based neurocognitive assessment tool, which would make it     easier for patients to complete these tests in follow-up. If this new tool is found to     reliably measure neurocognitive function, it could be used for future studies evaluating new     interventions that prevent or treat neurocognitive deterioration following treatment of brain     metastases. This is the first prospective study to evaluate the feasibility and reliability     of a novel telephone-based brief neurocognitive assessment battery (Toronto BNB) compared     with the same battery delivered face-to-face in this population. The investigators     hypothesize that telephone administration of this brief neurocognitive battery will reliably     evaluate neurocognitive function and improve patient ability to complete follow-up     assessments.   "
91944|NCT02082574|"     Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability     in the general population, secondary to the accumulation of asymptomatic elementary lesions.     CSVD is directly correlated with age and cardiovascular risk factors and therefore would be     challenging in term of public health care in the future. While HIV patients share the same     cardiovascular risk factors and they are often diagnosed with cognitive impairment and     frailty, CSVD has not been yet described in this population.      The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population     compared to HIV- controls matched with age and sex.      500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD     with a 10 minutes MRI (FLAIR and T2*).      Prevalence of the CSVD will be compared between HIV+ patients and controls. General and     HIV-specific parameters from their electronic medical records will be compared between     HIV+/CSVD+ and HIV+/CSVD- patients.      We are expecting to prove that CSVD is more frequent in HIV+ population.   "
91945|NCT02082561|"     The aim of the current study was to test the efficacy of an individually administered, brief     (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called     F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive     strategies (so-called safety aids) among individuals suffering from a range of anxiety     disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and     panic disorder (PD). We hypothesized that the F-SET protocol would produce better overall     outcome relative to a waitlist control.   "
91946|NCT02082548|"     To determine whether a comprehensive evaluation and customized multilevel educational     interventions will increase the rate of use of oral anticoagulants and the adherence and     persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be     differences in the use of oral anticoagulants and the persistence in patients between the     control and interventional group. There will be a greater change in the use of oral     anticoagulants over one year in the cohort in the intervention sites than the control sites.     This will be due to two factors: greater initiation of oral anticoagulants among patients not     treated at baseline and greater persistence of treatment for those on treatment at baseline   "
91947|NCT02082535|"     The improvement of treatment of preterm neonates improved their survival, however there is     still significant portion of preterm infants (specifically very preterm infants) that suffers     from brain insults and as a result developmental deficits. The brain injury is a consequence     of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and metabolic     crisis. The brain injury is a combination of abnormal myelination, axonal damage and neuronal     death. Although there is reduction in focal brain injury, diffuse brain injury is still     abundant. Several treatments has been suggested and tested in animal models to prevent the     brain insults including glutamate receptor blockers, allopurinol, xenon and different types     of stem cells. However, two main obstacles prevent the use of these medication, first the     uncertainty of their effect on the developing brain and second the difficulty to time the     brain insult. Unlike neonatal asphyxia, when the delivery time and clinical signs are used to     time and grade the brain injury, in preterm infants there is no real time tool to indicate     severity and timing of brain injury. The disability point out a beneficial therapeutic window     is a major obstacle in the acute treatment of brain injury in preterm infants. The aim of     this study is to try and delineate such therapeutic window by using brain injury biomarkers.      S100b and GFAP are well recognized biomarkers of brain injury in adults, children and     infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly)     will be sampled. A database of the clinical status of the infants will be collected, as well     as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18     months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their     timing will be correlated with the severity of the clinical status, Two the duration of     increased level of S100b and GFAP will be associated with abnormal MRI at term findings and     abnormal developmental assessment.   "
91948|NCT02082522|"     Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is     activated by a light from a laser that emits no heat. This technique works to allow the     medical doctor to specifically target and destroy abnormal or cancer cells while limiting     damage to surrounding healthy tissue. The activation of the drug is done by lighting the     abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits     light transmission) inserted into a flexible tube with a light called cholangioscope for the     bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue,     leading to its destruction.      This research study will evaluate the efficacy and safety of PDT with porfimer sodium     administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival     time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile     ducts. It will involve 200 patients across North America and Europe. Other countries may     participate if needed. Participation will last at least 18 months.   "
91969|NCT02082249|"     This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in     subjects with advanced Parkinson's disease.   "
91949|NCT02082509|"     One of the most common symptoms suffered by traumatic brain injury (TBI) patients is     disruption in attention. Lack of attention impacts daily life including academic or     professional tasks, and interpersonal relationships. The focus of Therapeutic Resources for     Attention Improvement with Neuroimaging for Traumatic Brain Injury (TRAIN-TBI) is to     investigate the changes in neurological function with special interest in attention after TBI     for children ages 8 to 16. This study will be done through advanced neuroimaging procedures,     neurocognitive testing, and an online training tool created by The Brain Plasticity     Institute. The investigators hypothesize that the training will improve attention in TBI     subjects and that the advanced imaging will show corresponding neural connectivity changes,     as compared to matched healthy controls.   "
91950|NCT02082496|"     The obesity epidemic is attributable to dietary and behavioral trends acting on a person's     genetic makeup to determine body mass and susceptibility to obesity-related diseases. Common     forms of obesity have a strong hereditary component and many genetic pathways that contribute     to obesity have already ben identified.      Glucagon-like peptide (GLP) -1 is an incretin hormone that potentiates glucose-stimulated     insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the     appetite center in the hypothalamus. Today, GLP-1 agonists are available for treatment of     type 2 diabetes, and their treatment potential in obesity is an area of active research.      The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in     people diagnosed with obesity causing genetic disorders and to investigate the physiological     role of GLP-1 on food intake and appetite regulation in this group.   "
91951|NCT02082483|"     Kidney transplant candidates are at very high risk for coronary artery disease (CAD). The     optimal strategy to monitor and maintain the cardiac fitness of patients awaiting kidney     transplantation is unknown. Currently patients undergo annual testing; however, screening for     CAD may increase morbidity and mortality by:        1. exposing patients to the risk of angiography and revascularization procedures        2. delaying or excluding patients from life saving transplantation.      Before proceeding with a definitive study to determine whether screening is necessary,     feasibility will be determined in this pilot study.   "
91952|NCT02082470|"     This pilot clinical trial studies survivorship care planning in supporting quality of life in     ovarian cancer survivors following primary treatment. Survivorship care plans have the     potential to empower patients and provide them with a plan of care following treatments.     Survivorship care planning may support patient's overall well-being and quality of life after     treatment of ovarian cancer.   "
91953|NCT02082457|"     This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel     Syndrome With Constipation. The difference of responder rate between test group (10, 20 and     40mg) and placebo will be evaluated.   "
91954|NCT02082444|"     Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically     proven insights into cognitive effects of lunch to the existing recommendations for school     meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an     enhancement of CogniDo this study investigates the short-term effects of having school lunch     versus skipping it on children's executive cognitive functions in the afternoon. The study     was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215 children.   "
91955|NCT02082431|"     The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large     cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing     loss.   "
91956|NCT02082418|"     Aging modifies the metabolic pathway of the neurotransmitter serotonin by reducing the     synthesis rate and increasing the breakdown rate of serotonin, possibly related to the     observed enhanced sensitivity of the serotonergic pathway. Since serotonin plays a prominent     role in neuropsychological functions such as anxiety, mood and memory, the enhanced     sensitivity of the serotonergic pathway in aging can probably explain the fact that elderly     are more vulnerable to develop cognitive deficits and depressive symptoms.      Serotonin synthesis in brain is regulated by its precursor tryptophan (TRP). Because     tryptophan is an essential amino acid, modifying the availability of tryptophan through     dietary intake, can directly influence central serotonin metabolism and consequently     affective and cognitive processes.      The aim of this study is to test the hypothesis that an acute intake of whey protein with     high levels of TRP such as alpha-lactalbumin can stabilize the metabolism of serotonin and     subsequently enhance metabolic and cognitive functions in healthy older adults. The acute     effects of this dietary protein will be investigated in subjects with mild cognitive     impairment (MCI), or dementia, compared to control subjects in order to examine whether     healthy older subject with MCI benefit more from the intake of alpha-lactalbumin and/or whey.     The investigators will investigate if this meal can optimize serotonin metabolism by     elevating plasma TRP levels and plasma TRP appearance and enhance splanchnic TRP extraction.     In addition, the effects on mood and cognitive functions will be examined.   "
91957|NCT02082405|"     This phase II trial studies the side effects and how well lower doses of bortezomib,     dexamethasone, and cyclophosphamide work in treating older patients with multiple myeloma.     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving cyclophosphamide daily may kill more cancer cells. Giving     bortezomib, cyclophosphamide, and dexamethasone may be an effective treatment for multiple     myeloma.   "
91970|NCT02082236|"     The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK)     of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and     compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg     administered 20 minutes apart.   "
91971|NCT02082223|"     A pilot to test feasibility of improving patient/caretaker quality of life and resilience.   "
92074|NCT02080884|"     This study will examine the effectiveness of MabThera therapy added to a standard     chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia     (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are     eligible. The overall response rate of patients treated for approximately 5 months (as per     current label guidelines) will be analysed according to various factors (i.e., age,     concurrent treatment, and chromosomal abnormalities).   "
91958|NCT02082392|"     The goal of this study is to develop new methods of administering antidepressant medications     that will result in improved drug/placebo separation in randomized controlled trials (RCTs)     for Major Depressive Disorder (MDD) and enhanced medication response in open clinical     treatment. The highly intensive, weekly visit schedule followed in most antidepressant RCTs     radically differs from how antidepressant medications are prescribed in standard clinical     practice and is believed to be a major reason why the majority of studies submitted to the     Food and Drug Administration (FDA) fail to show a significant difference between medication     and placebo. Moreover, a one size fits all approach to psychopharmacologic management     (i.e., weekly visits for all patients) does not take into account differences between     patients that may predispose some individuals to respond positively to frequent follow-up     visits, while others may respond negatively or not at all. Clinic visits comprise multiple     components that may be therapeutic for depression, including activating patients' behavior,     exposing them to medical procedures, permitting social interactions with research staff, and     providing supportive meetings with clinicians. Two independent meta-analyses have associated     more frequent study visits with increased antidepressant and placebo response as well as     decreased separation between medication and placebo. Despite the high costs and potential     disadvantages of weekly follow-up visits for patients receiving antidepressant medication,     this clinical management strategy has not been studied prospectively to date. It is unknown     whether weekly follow-up visits are needed to ensure treatment compliance and patient safety     in clinical trials and to what degree contacts with clinicians influence medication and     placebo response.   "
91959|NCT02082379|"     We hypothesize that infant and children will show different levels of acceptance of different     interfaces while they receive inhaled therapy.      We also hypothesize that children will exhibit different amounts of time with the aerosol     well aligned with the nostrils during transnasal aerosol delivery.   "
91960|NCT02082366|"     The aim of the investigators study is to analyze the incidence of MES by TCD performed during     AF ablation with the nMARQ and to compare is with the incidence of MES using a conventional     irrigated ablation catheter. Objective: To investigate the incidence of MES on TCD during AF     ablation with the nMARQ catheter compared to a conventional irrigated ablation catheter.     Following inclusion, patients will be randomized into 2 equal different treatment groups: PVI     with traditional irrigated RF catheter versus PVI using the nMARQ catheter. In all patients,     anticoagulation therapy with warfarin is discontinued five-days before the procedure and low     molecular weight heparin is initiated at that time. A CT-scan of the left atrium is performed     and imported into the Carto 3 mapping system. The ablation procedure is conducted under     general anesthesia or conscious sedation. A decapolar catheter is positioned in the coronary     sinus and a quadripolar catheter is positioned at the His bundle level through the right     femoral vein. Two 8F sheaths are introduced into the left atrium with double trans-septal     puncture performed under fluoroscopic, trans-esophageal echocardiographic or intracardiac     echocardiography guidance. Upon completion of the first trans-septal puncture, intravenous     heparin is administered to maintain an activated clotting time of 350 seconds throughout the     procedure. A variable Lasso circular mapping catheter is introduced through the SL1 sheath     into each pulmonary vein for electrical mapping. After the second trans-septal puncture, a     Navistar Thermocool 3.5mm irrigated ablation catheter or an nMARQ circular irrigated ablation     catheter are introduced into the left atrium. Of note, in case of use the nMARQ catheter, the     second SL-1 sheath is replaced by a steerable 8F agilis sheath after the second trans-septal     puncture. Each of the 4 PVs are imaged by selective angiograms. The left atrium geometry is     created using the nMARQ catheter or the Navistar catheter and then merged with the     pre-acquired CT scan of the left atrium and PVs. Identiﬁcation of true MESs will be possible     using an event detector system, in addition to determining whether the MESs are attributed to     a solid or to a gaseous embolus. Total MES counts will be collected and evaluated separately     during different stages of the procedure.   "
91961|NCT02082353|"     Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone     marrow transplantation has been shown to be curative. However the risks of transplantation     are high and not all patients with CGD may need to undergo this high risk procedure. This     study will determine the long term medical condition and daily functioning of patients with     CGD after a transplant and if possible, compare these results to patients who do not undergo     a transplant.   "
91962|NCT02082340|"     Randomized trial tests effectiveness of self-administered drug intake by empowered TB     patients - supervised by a trained family member and supported by medical counseling and     reminders - to improve treatment adherence and treatment success rates, and thereby forestall     TB and MDR-TB epidemics.   "
91963|NCT02082327|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV     migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as     compared to IV administered migalastat HCl in healthy volunteers. The data from this study     will help us understand how migalastat works in the body and will help us determine what     would be an effective dose in future studies with migalastat hydrochloride.   "
91964|NCT02082314|"     Bone metastases are a cause of significant morbidity in cancer patients. In patients who die     from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have     evidence of bone metastases at the time of death (1). These metastases frequently give rise     to complications that reduce patients' quality of life. These include: pain, fractures, and     decreased mobility, ultimately reducing performance status.      Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone metastases     has been shown to be feasible, efficacious, and safe. However, patient reported outcomes have     yet to be determined.   "
91965|NCT02082301|"     This is an observation study of women with gestational diabetes. Subjects recruited undergo     immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt     diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an     immediate post partum screen for overt diabetes compared to a traditional 6 week test.   "
91966|NCT02082288|"     Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI)     according to EIOS   "
91967|NCT02082275|"     The study defines a new model of prenatal care called OB Nest which will be compared to the     traditional model of prenatal care. OB nest is intended to create an experience for patients     that feels more connected and patient-centered, allowing the patient to visit the clinic less     frequently while offering increased communication with the OB nurses and providers through     new tools provided to the patient. The goal of the project is to promote patient-centered     care through a new prenatal care program based on constant and direct support from a nursing     team, meeting the on-demand needs of expecting mothers as they rise, and as thus, redesigning     the need and timing of on-site appointment with providers. Pregnant women randomized to the     OB Nest cohort will see the number of pre-planned visits with their providers decreased and     replaced with more direct and constant support and interaction with an assigned nursing team.   "
91968|NCT02082262|"     This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal     or perennial allergic conjunctivitis.   "
91972|NCT02082210|"     The purpose of this study is to find a recommended schedule and dose range for LY2875358 when     given with ramucirumab that may be safely given to participants with cancer. In Part A of     this study, escalating doses of LY2875358 will be given in combination with a fixed dose of     ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose     range of LY2875358 and ramucirumab has been established, Part B of the study will confirm     safety and to see how well certain tumors respond to the combination of study drugs. The     average amount of time on study is expected to be about 6 months.   "
91973|NCT02082197|"     This is an open-study with a 26 week open label treatment period followed by an optional 26     week open label extension. The total treatment period will be 52 weeks.   "
91974|NCT02082184|"     To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic     control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised     controlled study design in adults with Type 2 diabetes using insulin.   "
91975|NCT02082171|"     Prevention of physical disability represents a major priority for the public health system.     Physical disability is the final result of a complex cascade of negative events occurring at     different levels (i.e., environmental, social, biological, and clinical). The heterogeneity     of the underlying mechanisms responsible for the onset of physical disability may require the     adoption of preventive interventions affecting multiple domains. Although several studies     suggest that single or different combinations of preventive interventions (in particular,     physical activity, cognitive training, and healthy diet) might provide beneficial effects in     preventing functional loss (and its related features, such as pain or reduced quality of     life), very limited evidence coming from clinical trials is currently available on the topic.     Intervention trials are usually designed to test the effect of a specific monodimensional     intervention on a very selected population, so to reduce the risk of biased results. This     approach, although legitimate and methodologically correct, may 1) be insufficient to target     the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical     disability, and 2) cause a population selection bias leading to difficulties in implementing     the study results to the overall older population (thus, determining the evidence-based     medicine issue in the elderly). To our knowledge, there are no available data from clinical     trials evaluating the effects of a multidomain intervention based on lifestyle modifications     (e.g., physical activity, cognitive training, nutritional modification) for preventing     mobility disability (a very early phase of the disabling process) in community-dwelling older     persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers,     MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain     person-tailored preventive intervention (based on physical activity, cognitive training, and     nutritional modifications) on frailty status, physical performance, cognitive function,     nutritional status, health-related quality of life, and use of health care services. In     addition, we will perform cost-effectiveness analyses of the proposed intervention. The     project will yield the necessary preliminary data to design a definitive full-scale Phase 3     randomized clinical trial. By providing a conclusive answer about the effectiveness of a     multidimensional preventive program in the primary prevention of major health-related     outcomes, the results of the full-scale trial will have relevant clinical and public health     implications, and will promote the practicing of a truly evidence-based geriatric medicine.   "
91976|NCT02082158|"     This VA-based study will obtain feedback from healthcare workers via validated survey     instrument on the comfort and tolerability of wearing current models of N95 respirators and     novel respirator designs currently in development. There will be 4 novel respirators and 1     commonly used respirator (not locally used) to compare to a locally used respirator, which is     familiar to participants. Comparisons will be examined between each of the first 5 models     with the locally used control using Dunnett's t-test.   "
91977|NCT02082145|"     To assess the effect of the device on the progression of diabetic peripheral neuropathy   "
91978|NCT02082132|"     The purpose of this study is to describe and compare the different types of diabetes that     exist in people from white European and south Asian origin in the UK (United Kingdom) who are     diagnosed with diabetes before they turn 30 years old. By doing this we hope to identify     cases of MODY (maturity onset diabetes of the young), which is a rare genetic cause of     diabetes that is frequently misdiagnosed. Identifying MODY cases is important, as the     treatment may differ to conventional treatment for type 1 or type 2 diabetes.   "
92215|NCT02079051|"     We are proposing a trial to directly compare a high intensity weight loss protocol to a     moderate intensity weight loss protocol to determine which leads to greater improvements in     physical function in severely obese older adults.   "
91980|NCT02082106|"     Problem description In industrialized countries there is a rapid increase in the number of     senior citizens. In Austria more than 50% of the population is overweight, with highest     prevalence in the age group from 60 to 74 yrs and the WHO lists physical inactivity as one of     the main behavioral risk factors of cardiovascular diseases.      Especially in winter months, activity related energy expenditure was 40% and 31% lower in the     US and Canada, respectively. In addition, in an Austrian study the winter season was     associated with higher blood pressure, total cholesterol and body mass index, giving an     increasing risk of chronic coronary disease by 6.8% in men and 3.6% in women.      Therefore, the development of intervention programs that overcome the winter physical     activity deficit and be feasible also for elderly should be goal of future research. Alpine     skiing (AS) and cross country skiing (XCS) have a long standing tradition in Austria and     could potentially fill the winter physical activity gap. The Salzburg Skiing for the Elderly     Study (SASES) has found AS to be a save and feasible possibility to improve the health of the     aged population in many parameters. XCS as a competitive sport is already well explored but     there are hardly any studies about its effects in the normal or elderly population.     Unfortunately knowledge about the differences between AS and XCS in the physiological     adaptation processes in the elderly population is also lacking.      Aims and hypotheses of the pre-study In order to standardize training interventions, the     present pre-study aims at comparing physiological and metabolic parameters between AS, XCS     and IT. Therefore, the results of the pre-study serve as determinants for the training     parameters of the above mentioned main study.      We postulate that, based on the results of the present study, it is possible to set up     comparable isocaloric training sessions for AS, XCS and IT for elderly and unfit persons.      Furthermore, we assume that elderly and unfit subjects are able to perform a full spectrum of     intensities and techniques necessary to set appropriate stimuli for isocaloric comparison.      We hypothesize arterial stiffness indices and circulating microRNA (miRNA) patterns to change     due to one bout of physical activity of AS, XCS, and IT with variations depending on the kind     of sport.   "
91981|NCT02082093|"     The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of a     telemedicine system : eNephro Application , compared with traditional care in the management     of chronic renal failure in different populations :        -  population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of          target blood pressure and proteinuria .        -  population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative          duration of hospitalization in short-stay        -  population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative          duration of unplanned short stay      Two statistical analysis will be done :        -  a main analysis for the one year initial follow-up for each patient        -  a secondary analysis for the one year initial follow-up estended by one year (proposed          to each patient at the end of the initial follow-up), that is a 2 years period.      The intervention tested in this study is a telemedicine system which is a collaborative and     expert system, consisting of:        -  A dynamic shared medical record for the collection of administrative , medical,          biological and clinical data for each patient. All health professionals can access the          folder and fill in the support. It is the same for patients treated at home.        -  A secure messaging for communication between health professionals and between patients          and health professionals        -  Expert systems analyzing data from each patient        -  A management tool of therapeutic education      Each patient and whatever the group will perform as part of its monitoring of the CKD     assessments at baseline , 6 months, 12 months, 18 months (Populations 1 and 2) and end of     study (24 months). These evaluations are about compliance, quality of life, anxiety -     depression state. To enhance costs the point of view retained will be health insurance's     point of view. Among the various costs, only direct costs are considered: disease management,     hospitalizations, consultations in hospitals and private practice, prescribed medical     transportation , home visits by health professionals, additional assessments related to the     evaluated intervention. A probabilistic matching with the data bases of the National     Information System of the Social Insurance will be performed. In addition, the acceptability     of the system of telemedicine by patients in the intervention and health professionals will     be also evaluated.   "
91982|NCT02082080|"     This study evaluates the effect of an interventional model for preventing and controlling     overweight and obesity in male and female fifth-graders. First, based on WHO (World Health     Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students     from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be     screened. Then from the screened students 30 students with the following inclusion criteria     will be recruited: not metabolically ill, not on a weight losing diet and not professionally     athlete. For selected students BMI-Z score as primary outcome will be calculated. Demographic     data, as well as data on waist and hip circumference, triceps skin-fold thickness, food     intake for 3 days (2 ordinary week days and 1 weekend) and physical activity will be     collected at the beginning and at end of the 6-month intervention. The approach of the study     will be Health Promoting Schools. The intervention includes three components, i.e., nutrition     education (students and parents), increased physical activity, and changing environment (food     items offered in schools' canteens). Nutrition education will be imparted (a 30-minute     session per week) by health instructors; physical activity will be done under the supervision     of the school coaches (2 one-hour sessions per week). Parents' education (a 1.5-hour session)     will be monthly. Finally the efficacy of the intervention will be determined and reported.   "
91983|NCT02082067|"     Aim of this study is to evaluate the effects of the adductor canal block on the early and     medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used     in the knee prosthesis.   "
91984|NCT02082054|"     This active vs active comparative trial will evaluate the safety and efficacy of incremental     doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult     patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal     symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by     statistical significance where p < 0.05.   "
91985|NCT02082041|"     The purpose of this study is to monitor the skin blood flow in the lower leg, with different     levels and types of applied loads. These loads will not be placed over the patient's wound     nor will they be higher than loads the skin normally experiences in daily activities. The     results of this research will help investigators understand the development of pressure     ulcers, commonly known as bedsores and stasis ulcers.   "
91986|NCT02082028|"     To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self     Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12     months in patients with type 2 diabetes not treated with insulin.   "
91987|NCT02082015|"     The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper     Extremity Motor Function Recovery in Patients with Ischemic Stroke   "
91988|NCT02082002|"     Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not     completely understood. Fatigue overlaps often with other symptoms such as somnolence,     depression and cognitive disorders, from which it is not always readily distinguished. The     evaluation of fatigue and the three most frequently associated symptoms using a     multidimensional approach might allow to understand, which methodology is the best indicated     to estimate the prevalence of fatigue with greatest accuracy, leading to a better     differentiation of the symptoms in the diagnostic setting.   "
92111|NCT02080403|"     The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine     gluconate chip) in the treatment of patients with Peri-implantitis.      The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival     debridement is more effective in the treatment of peri-implantitis when compared to the     common method of mechanical subgingival debridement alone. The primary efficacy measure will     be the reduction in probing pocket depth at 6 months as measured at sites of qualifying     target implant.   "
91989|NCT02081989|"     Renal denervation (the use of radio waves to oblate the renal artery) has been shown to be an     effective treatment for high blood pressure. It is currently being tested in heart failure     patients and we would now like to look it its effects on diabetes.      We therefore plan to enrol 20 participants with type II diabetes into this study. Half will     undergo renal denervation in addition to their standard care and the other half will act as     controls and only receive standard care. Treatment allocation will be randomly assigned.      All participants will undergo screening (including a physical exam, blood tests, ultrasounds     and a muscle biopsy). All patients will have follow up tests (including physical exams and     blood tests) 1, 3 and 6 months later.   "
91990|NCT02081976|"     Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity     all over the world. In the last years, efforts have been made to define more effective     therapeutic and preventive strategies.Periodontal diseases have been considered a probable     risk factor for CVD with a great amount of evidence from observational studies. Although     there are some interventional studies evaluating the systemic effects of periodontal therapy,     there is little information regarding the impact of periodontal treatment on the prevention     of cardiovascular events. To the best of our knowledge, there are no randomized controlled     trials published to date assessing the effect of periodontal therapy in primary prevention of     CVD.   "
91991|NCT02081963|"     This is a multi-centered, randomized, controlled study to assess the efficacy, indications     and adverse reactions of combined administration of nebulized amikacin in patients with acute     exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled     antibiotics are more likely to cause bacterial resistance.   "
91992|NCT02081950|"     This is a pilot, open-label study aimed at a preliminary evaluation of enoxaparin     bioavailability following two administrations of Clexane s.c. at a dose of 80mg, in two     different periods.   "
91993|NCT02081937|"     Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling     domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an     escalating dose. After completion of study treatment, patients are followed intensively for 6     months, every 3 months for 2 years, and annually thereafter for 10 years.   "
92075|NCT02080871|"     Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the     common and/or external iliac arteries.   "
92076|NCT02080858|"     Background:      The acute coronary syndrome (ACS) is a complication of coronary artery disease (CAD) and     associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic acid (ASA)     with P2Y12 receptor antagonists such as clopidogrel is a cornerstone in the treatment of     patients with advanced CAD. Due to delayed onset of action, intersubject variability or     resistance to clopidogrel, different platelet aggregation inhibitors have been developed.     Ticagrelor is a reversible P2Y12 receptor antagonist with superior efficacy compared to     clopidogrel in the prevention of cardiovascular death in these patients.      Atrial fibrillation (AF) is also associated with thromboembolic events and substantial     mortality. Beside vitamin K antagonists (VKA, phenprocoumon) for stroke prevention in     patients with AF, the direct factor Xa inhibitor apixaban has recently received approval for     prophylactic treatment of patients with non-valvular AF.      However, there is a lack of efficacy or safety data for the combined impact of antithrombotic     drugs in patients requiring arterial and venous thromboembolic prophylaxis due to their     underlying co-morbidities. One trial suggests treatment with VKA + clopidogrel without ASA as     equal effective as antithrombotic triple therapy (with ASA) in this population. However, the     effect in combination with novel oral anticoagulants has not been investigated so far.      Study objectives:      To evaluate the effect of ticagrelor + apixaban in combination with or without ASA at steady     state on markers of coagulation activation and on thrombus size in an ex vivo perfusion     chamber experiment. Additionally, plasma samples will be analysed for PK-data (ticagrelor &     apixaban concentrations)      Study design:      A single-centre, prospective, sequential, controlled, analyst-blinded study in two groups.     Subjects will receive ticagrelor + apixaban in combination with (study A) or without (study     B) ASA. All IMPs will be administered at doses indicated for stroke prevention in AF (lower     dose: 2.5mg due to ethical concerns) or ACS. Markers on thrombin generation and platelet     activation will be studied in venous blood where coagulation is in resting state and in shed     blood where the clotting system is activated in the microvasculature in vivo: prothrombin     fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT), β-thromboglobulin (β-TG). Additionally,     inhibition of factor Xa activity and concentrations of ticagrelor and apixaban will be     assessed in venous blood. Further, thrombus size of clots formed in an ex vivo perfusion     chamber will be determined by measurement of D-Dimer and p-Selectin levels.      Study population A total of 40 healthy, non-smoking and drug-free male volunteers will be     enrolled (study A and B; n = 20 per group).      Main outcome variables:        -  β-TG in shed blood      Additional outcome variables:        -  F1+2 and TAT in shed blood        -  fibrin formation (D-Dimer) and platelet deposition (p-Selectin) in an ex vivo perfusion          chamber model of thrombosis        -  β-TG, F1+2, TAT & inhibition of factor Xa in venous blood        -  PT, aPTT and ACT in venous blood        -  ticagrelor & apixaban plasma concentrations        -  shed blood volume   "
95595|NCT02034864|"     The purpose of this study is to determine whether a standardised osteopathic manipulative     treatment is more effective on 3 months functional recovery than a placebo of osteopathic     manipulative treatment, in sub-acute and chronic low back pain less than 1 year duration.   "
91994|NCT02081924|"     The purpose of this study is to determine the physiological effects of sustained     administration of the natural hormone kisspeptin on reproductive function in participants     with reduced fertility. Kisspeptin is a recently identified natural hormone which is     regulates human reproduction. Learning more about the physiological role of kisspeptins may     therefore give us a better understanding about human fertility, and improve the management of     patients with reduced fertility. The effects of sustained administration of kisspeptin on     hypothalamic reproductive function (i.e. Luteinising hormone pulsatility) are not known.   "
91995|NCT02081911|"     The purpose of this study is to investigate whether there is quantitative motor-sparing of     the quadriceps muscles following adductor canal nerve block versus femoral nerve block.     Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block,     2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume.     Quadriceps function will be assessed in the operating room using a skin patch and electrical     stimulation. Follow up visits with the patients will continue over the course of 2 days     during patient's stay at the hospital. A total of 60 patients will be enrolled for the study.   "
91996|NCT02081898|"     The effect of weight loss with long-term low calorie diet (LCD) on plasma metabolites is     unknown. The aim was to examine whether a LCD-induced weight reduction results in changes in     the extended plasma metabolites.   "
91997|NCT02081885|"     Introduction After a mandibular fracture where bone has been lost, a number of complications     and challenges are presented in trying to solve them. These defects are mainly classified     into two groups: functional and cosmetic. The functional defects are incompetence of the     lower lip, salivary incontinence, severe difficulty chewing and swallowing, temporomandibular     joint disorders and difficulty in pronouncing words.      Esthetically facial asymmetry is produced with collapse of the affected side. Unreconstructed     jaw retrusion and tends to offset the affected side, there is a change in mandibular     movements, which, previous vertical movements are replaced by oblique or diagonal movements     controlled by a single temporomandibular joint. It also presents a limitation in motility and     lingual force, besides proprioception disorder left by the inferior alveolar nerve The loss     of bone in mandibular fractures, is one of the great challenges facing maxillofacial surgery     and unfortunately increasingly common. That's why they have done and are still doing research     for the development of biomaterials, all with the purpose of trying to solve this problem by     offering the patient better results than those obtained in the past, restoring both function     and facial aesthetics according to each case   "
91998|NCT02081872|"     UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians     manage patient medication regimens and assess if the testing has an effect on reducing     adverse drug reactions, hospitalizations and emergency department visits.      The way an individual processes a drug is in part determined by their genes, and there is     known to be genetic variation between humans in the way drugs are metabolized. The study of     the way genes affect a person's response to drugs is known as Pharmacogenomics.   "
91999|NCT02081859|"     This is a randomized controlled observational trial to determine if data obtained from the     embryoscope is helpful in determining which blastocysts to transfer.   "
92001|NCT02081833|"     This study serves as a feasibility study for a birth cohort study to investigate the     influence of the sequence and load of infections and vaccinations on the development of the     immune system of children. In this study, the investigators aim to test the methods developed     to capture acute respiratory and gastrointestinal infections and their consequences of     children aged 1 to 3 years in Braunschweig, Germany. Furthermore, the investigators want to     study the influence of the environment on the microbiome of children by comparing children of     the same child care centre with children from different child care centres. The methods     developed include a symptom diary which has to be filled out on a daily basis by the parents.     Furthermore parents are asked to take monthly anterior nasal swabs and stool samples from the     study child independent from symptoms as well as one sample if symptoms occur. The parents     are provided with instructions and the first nasal swab will be demonstrated by trained study     personal. The study is powered to compare nasal swabs taken by the trained staff and the     parents as primary outcome. Secondary outcome is the performance of reminders sent to the     study participants. The diary and the specimen will be mailed to the Helmholtz Centre for     Infection Research where they will be analyzed for the nasal and gut microbiome. The nasal     swabs taken at the time of an infection will be tested for respiratory viruses. After the     study period of 3 months parents will be asked about the feasibility and acceptance of the     symptom diary and taking the nasal swabs and stool specimens by means of questionnaires and     interviews (face to face and focus groups). This will help our understanding of the     feasibility and acceptance of the methods developed to capture acute respiratory and     gastrointestinal infections of children and our understanding of the development and     composition of the nasal and gut microbiota.   "
92002|NCT02081820|"     In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is     considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to     estimate the average plasma glucose concentration over prolonged periods of time, thus     determination of glycated hemoglobin at admission after aSAH serves as an approximation of     blood glucose levels in the weeks preceding aneurysm rupture. In this patient registry     admission HbA1c, clinical course and neurological outcome after 6 month are recorded, to     determine whether elevated blood glucose levels prior to aneurysm rupture influence the     clinical course and patient outcome after aSAH.   "
92003|NCT02081807|"     This cohort study is the sequential expansion of the comparative effectiveness study of oral     anticoagulants and plans to identify initiators of oral anticoagulants using electronic     claims data from a commercial insurance database to quantify associations between     anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in     patients with non-valvular atrial fibrillation at risk for stroke.   "
92004|NCT02081794|"     This randomized pilot clinical trial studies tailored patient educational intervention or     standard education in assessing perceived risk for falls in hospitalized oncology patients. A     tailored patient educational intervention may be more beneficial than standard education in     preventing patients from falling by increasing the patient's knowledge of the risk factors     for falling routinely and then providing education in deficit areas. Making patients more     aware of the risk factors for falling may lead to greater engagement in preventative     activities.   "
92005|NCT02081781|"     The purpose of this study was to investigate various potential factors that affected the     outcome of treatment of congenital nasolacrimal duct obstruction.   "
92044|NCT02081274|"     High tidal volume during mechanical ventilation has been reported to increase mortality in     patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was     also reported to be associated with increased mortality in adult patients without acute lung     injury or acute respiratory distress syndrome. However, the influence of high tidal volume on     clinical outcome in pediatric patients who underwent surgery for congenital heart disease has     not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on     clinical outcome in both cyanotic and non-cyanotic congenital heart disease.   "
92006|NCT02081768|"     There is no consensus in the literature on the best way to treat cystic lesions of the     pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of     tumours present special challenges since traditional treatment modalities (surgery and/or     external radiation) are often not able to completely remove or treat the cyst wall without     major morbidity or even mortality.      There is no 'best practice' for the treatment of cystic tumours per se. Treatments available     to patients with cystic sellar/parasellar tumours include conservative management using a     'wait and scan' approach, cyst drainage, and cyst removal via transsphenoidal and/or     craniotomy approach (i.e. open surgery). Over the last 10 years we have treated approximately     8 patients with intracystic radiotherapy. All of these patients continue to be monitored     clinically and radiologically and all have done well with stable regression of the cysts and     no new neurological deficits. Over the past 2 years, 90yttrium colloid has been provided to     CDHA through Health Canada's Special Access Program (SAP). It has only been of recent that     Health Canada has requested a clinical trial to assess the benefit of intracystic     radiotherapy over other available treatment options.      The experimental treatment being proposed is the stereotactic intracavitary instillation of     90yttrium colloid for treatment of cystic lesions of the pituitary (sellar) and surrounding     areas (parasellar).   "
92007|NCT02081755|"     This study is a prospective Phase IV study to determine if the use of Everolimus results in     lower liver tumor recurrence and improved patient and graft survival after liver transplant     for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and     Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil.     Primary outcomes data is disease free survival (the time from randomization to HCC recurrence     or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to     wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal     function, acute cellular rejection, post-transplant diabetes, hypertension, and     hyperlipidemia.   "
92008|NCT02081742|"     Summary Colorectal cancer (CRC) represents the second leading cause of cancer deaths in Spain     (11,000 deaths per year). Screening of the population over 50 years of age with no     significant history (intermediate risk) is recommended, but which screening method is best     for promoting adherence in this type of patient has not been well established. There are     currently two screening methods that are less invasive than conventional colonoscopy and seem     to have higher sensitivity than the test for faecal occult blood (FOBT). These two methods     are the colon capsule, which consists in ingesting a capsule that takes photographs of the     colon, and virtual colonoscopy, which is a radiological technique.      Objectives: 1. To demonstrate that virtual colonoscopy and colon capsule are effective CRC     screening techniques in the intermediate risk population, with diagnostic rates comparable to     conventional colonoscopy (concordance). 2. To compare the diagnostic rates of the colon     capsule and virtual colonoscopy with respect to the size and characteristics of the lesions     visualised. 3. To compare the participation rates for each screening strategy and identify     the factors that influence participation (individual, family, and socioeconomic factors as     well as those relating to the doctor).   "
92009|NCT02081729|"     VZV is one of the important opportunistic infection in transplant recipients.Until now, there     is no laboratory method to stratify the risk of VZV reactivation after solid organ     transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ     transplantation will further categorize the patients into high or low risk of VZV development     after solid organ transplantation. The investigators thus evaluate the usefulness of     VZV-specific ELISPOT assay in kidney transplant candidates to predict the development of VZV     infection after kidney transplantation.   "
92010|NCT02081716|"     CMV is one of the most important opportunistic infection in transplant recipients. In South     Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity     for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to     stratify the risk of CMV reactivation after solid organ transplantation. Theoretically,     CMV-specific cell-mediate immune response before and after bone marrow transplantation will     further categorize the patients into high or low risk of CMV development after bone marrow     transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay     in bone marrow transplant candidates to predict the development of CMV infection after     transplantation.   "
92011|NCT02081703|"     The objectives of this study are to evaluate the safety and analgesic efficacy of a single     preoperative intrathecal administration of AYX1 Injection at two dose/volume levels.   "
94775|NCT02045589|"     The purpose of this study is to determine the safety and tolerability of three intratumoral     injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended     phase II dose of VCN-01 combined with Abraxane®/gemcitabine.   "
92012|NCT02081690|"     Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study.      Primary objectives: To evaluate the psychometric characteristics of reliability and construct     validity of the French, Italian and Spanish versions of the PAH-SYMPACT™.      To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to     detect change.      Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial     hypertension (PAH).      Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact     (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.   "
92013|NCT02081677|"     There will be four study lenses tested; one marketed lens, and three prototype study lenses.     Subjects will be randomized to one of the four study lenses which will be worn in a daily     wear modality, with a two week replacement.   "
92045|NCT02081261|"     Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and     has been reported to be associated with adverse outcome. There have been many studies     reporting risk factor of acute kidney injury after cardiac surgery, but the influence of     perioperative variables related to anesthesia and perioperative medication has not been     evaluated fully. The investigators attempt to evaluate the influence of perioperative     clinical variables including preoperative medication, preoperative albumin level, uric acid     concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level,     intraoperative medication, perioperative cardiac function (systolic and diastolic function)     and hemodynamic variables during surgery on the incidence of acute kidney injury after     coronary artery bypass graft.   "
92014|NCT02081664|"     Some patients report relief of symptoms after amalgam removal. However, a large group of     patients are still suffering from partly severe health complaints even after the removal of     amalgam. To date, no biological/medical explanation for these Amalgam attributed health     complaints is available.      The objective of this study is to develop an integrated medical care rehabilitation program     and determine if it is a valid and feasible treatment for patients with persistent symptoms     after amalgam removal. Such a comprehensive concept has to date not been operationalized in     Norway, but information about the feasibility and the challenges around such a rehabilitation     program are required, in order to prepare for a possible controlled and randomized study     evaluating the effects of the suggested integrative care treatment program. This treatment     program will focus on learning by practicing, hence the study participants will be enrolled     into a group program focusing on life-style changes. In addition to the life-style oriented     group program, an individualized treatment strategy with therapies out of the spectrum of     Complementary and Alternative Medicine (CAM) will be part of the treatment program. This part     of the program is based on the results of a survey, related to use of CAM therapies,     conducted in 2012 among the members of the patient organization Forbundet Tenner og Helse.      Participants of this treatment program must amongst other inclusion criteria have removed all     dental amalgam fillings and experience symptoms which have not disappeared after removal of     the dental fillings. Specific exclusion criteria are stated. The group program consists of 12     sessions which are held once per week for a whole day. Added to this is a choice of CAM     therapies from a hierarchic list, established from the survey, and which accordingly is based     on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks (end of     treatment), and three month later. The aim of this study is to test the feasibility of an     integrated medical care rehabilitation program for patients in Norway who have had their     Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It combines a     lifestyle oriented group program with individualized CAM therapies in form of an outpatient     program.   "
92015|NCT02081651|"     Cow's milk allergy is the most common food allergy in children. The scenery clinical and     epidemiological of cow's milk allergy is significantly changed in the last decade. The     severity of the clinical manifestations is still rising, and now cow's milk allergy has     become the leading cause of hospitalization for food -induced anaphylaxis in our country. In     addition, the overall prevalence of cow's milk allergy is increasing for a gradual reduction     in the ability to acquire immunological tolerance to cow's milk protein in the first years of     life. These mutations dictate the need to identify strategies to stimulate the acquisition of     immunological tolerance in children affected by cow's milk allergy . The mechanisms of     acquired immunological tolerance are not yet fully defined . The current view suggests the     existence of a dynamic mechanism , consisting of various cellular compartments , which is set     in a crucial environmental factors arising mainly from the diet and its effects on the     intestinal microbiota. These acquisitions have contributed to the definition of a new concept     in the field of human nutrition: immunonutrition. The immunonutrition is the ability, through     the intake of specific nutrients on the immune system to interfere directly or indirectly     through modulation of the composition and function of the intestinal microbiota. The     proponent group has recently shown that it is possible to stimulate a more rapid acquisition     of immunological tolerance in children affected by CMA through the administration of     extensively hydrolysed casein containing the probiotic Lactobacillus rhamnosus GG (LGG)     (Berni Canani et al. J Pediatr 2013) . Several lines of evidence suggest that this effect is     induced by a combination of direct immunomodulatory action exerted by some small peptides     derived from the beta - casein and the action of lactobacillus GG. It 's well known that the     Lactobacillus GG is able to adjust the composition and functions of the microbiota in the     child with CMA and directly adjust some immunological mechanisms involved in the pathogenesis     of this condition. At the same time other groups have demonstrated the possibility that a     high percentage of patients with IgE-mediated CMA is able to tolerate foods containing     hydrolyzed cow's milk proteins with different processes. It has also been speculated that     these strategies can facilitate the acquisition of immune tolerance in patients with cow's     milk allergy. One of these foods is Parmigiano -Reggiano cheese, which is characterized by an     ' extensive hydrolysis of the proteins in cow's milk , which degrade the caseins present and     generate large amounts of peptides and free amino acids and by the presence of appreciable     quantities of Lactobacillus GG in the samples to maturing higher . In a recent study it was     shown that 58% of patients suffering from IgE-mediated CMA is able to tolerate a daily intake     of normal amounts of this food , especially in the absence of a sensibilization to IgE     specific to the beta lactoglobulin. These new findings allow us to hypothesize the use of     Parmigiano REggiano cheese as a possible strategy immunonutrition can stimulate the     acquisition of immune tolerance in patients with CMA .   "
92016|NCT02081638|"     Background:      - The immune system protects the body from infection. But it can also cause harm. For     example, the clotting system makes blood clot and protects from bleeding. But blood clots are     sometimes harmful. People with human immunodeficiency virus (HIV) infection have increased     inflammation and clotting. This may increase their risk for diseases like stroke or heart     attack. Researchers want to know how aspirin or HMG-CoA reductase inhibitors (so-called     statin medications) affect the immune and clotting systems of people with HIV. Aspirin is a     medicine to decrease clotting. Statins are medications given to lower cholesterol and     decrease inflammation.      Objectives:      - To see how aspirin or statins change immune and clotting systems in people with HIV.      Eligibility:      - Adults 18 and older with HIV and a low viral load, not on aspirin or a statin medication.     They must also have either: (1) never taken anti-HIV medications (ARVs), have a suppressed     viral load, have stable CD4 counts, and never had an opportunistic infection; or (2) been     taking ARVs for 5 continuous years and have a suppressed viral load for more than 3 years.      Design:        -  Participants will be screened with medical history, physical exam, and blood and lab          tests.        -  Participants will repeat screening tests and have an MRI. An MRI is a way to visualize          blood vessels in the neck and head. Participants will lie on a table that slides in and          out of a cylinder surrounded by a magnetic field.        -  Participants will take either study drug once daily for 9 months.        -  Participants will have a blood procedure twice. Blood will be removed through a needle          in one arm and circulated through a machine that removes white blood cells. The blood,          minus white blood cells, is returned through a needle in the other arm.        -  All participants will be observed for 3 months before and after treatment.   "
92017|NCT02081625|"     This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (PK)     of NS-065/NCNP-01 in subjects diagnosed with Duchenne muscular dystrophy (DMD).   "
92018|NCT02081612|"     This study looks at the benefit of adding acupuncture to nutrition education for weight loss     in women with early stage breast cancer post-chemotherapy.   "
92019|NCT02081599|"     The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in     combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to     evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an     extension treatment for up to 52 weeks.   "
92020|NCT02081586|"     This is a pilot study examining the clinical effects of a brief Cognitive Therapy phone     approach augmented with a CBT smartphone app geared towards patients with type 2 diabetes     patients in poor control.   "
92070|NCT02080936|"     Peripheral muscle mass and strength are relevant indicators of COPD survival. Current     guidelines recommend to assess muscle strength only in muscle wasted patients. However, a     recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp.     Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In     clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle     wasting. We aimed at determining the prevalence of patients entering in pulmonary     rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of     muscle wasting clinical signs.   "
92043|NCT02081287|"     Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a     naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown     preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in     bipolar disorder in some studies, but failed to establish efficacy in subsequent     meta-analyses. In the investigators proposed work, the investigators plan to orally     administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to     paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and     who have failed an adequate course of treatment with lithium monotherapy. The investigators     hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but     more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15     treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy     and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most     commonly used to treat bipolar disorder.   "
92021|NCT02081573|"     A significant problem in primary care healthcare delivery is the lack of interventions to     improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM).     Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications, and     self-management burdens is present in up to 70% of persons with T2DM. Distress is a     significant factor in medication nonadherence and poor glycemic control. Treatment adherence     is vital to maintain glucose control and reduce complications.      The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't     handle taking these medications), assumptions (e.g., I know I will have side effects to these     medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff) as     critical variables that impact both distress and T2DM treatment adherence. Current treatment     strategies within primary care do not address the dysfunctional thinking patterns that affect     the patient's distress level, T2DM medication adherence, and complex daily self-care     activities.      Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps     patients to identify, and restructure dysfunctional thinking patterns. We propose to test a     brief CBT approach delivered by nurse care managers and supported by a comprehensive mobile     phone CBT skills practice application (app) within primary care. The promising results of our     preliminary studies using a mobile phone app to stimulate real-time CBT skills practice     prompt us to propose a pilot of its use with patients with T2DM with the following aims:      Primary aim: examine feasibility and acceptability of the assessment protocol, and the     recruitment, and retention of study participants.      Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical     outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g.,     diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM     outcomes (HbA1c level and body mass index).   "
92022|NCT02081560|"     The blood concentration of the antibiotic colistin is determined in patients in whom kidney     function is reduced such that a renal replacement therapy is needed.      Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement     therapy over 24h because colistin is sufficiently removed by this procedure.   "
92023|NCT02081547|"     Risk of local recurrence after rectal surgery is nationally 8% after curative surgery to 5%.     Local recurrence rate after curative surgery varies between 3-7% in the variety of regions in     the country. It is well known that the surgical technique total mesorectal excision (TME) has     led to improved prognosis after rectal cancer surgery. TME surgery is difficult to perform     and different factors affect the quality of TME preparations. Injuries in mesorectal fascia     has been reported in up to 20% of patients who underwent TME surgery and most surgeons agree     that this may be important for recurrences. However, it is unclear to what extent a damaged     mesorectal fascia can be related to a worsening of prognosis in patients with rectal cancer.      Adjuvant oncological treatment in form of chemotherapy after surgery, is offers patients with     unfavorable tumors based on the pathological examination. Patients with favorable tumors     (less advanced) are not offered chemotherapy, even if the surgical technique was not optimal,     ie. that there is damage in the mesorectal fascia, as evidence for this is lacking.      The presence of intraperitoneal cancer cells (IPC) is related to histopathological tumor     stage of colorectal cancer. Incidence of IPC of intraperitoneal tumors (rectal cancer     patients with tumors below the peritoneal reflection) is unclear.      Assessment of IPC status with cytology and immunohistochemistry is technically easy and could     after TME surgery identify those patients who have an increased risk of tumor recurrence. In     a positive IPC status, the patient would possibly benefit from either postoperative     radiotherapy if the patient did not receive preoperative therapy, or postoperative     oncological chemotherapy.      Tumour cells may be lysed in sterile water, and some surgeons rinse the abdominal cavity and     the bowel distally to the tumour. Neither rinsing the abdomen or rectum in colorectal cancer     is routinely occurring and the clinical benefit has not been established. The value of     rinsing the abdomen after TME-surgery could also be studied by IPC status.      The study hypothesis is that the IPC status is dependent on the surgical quality of the     specimen after TME-surgery in rectal cancer patients, and its presence leads to increased     risk of local recurrence.   "
92024|NCT02081534|"     Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks     treatment period   "
92025|NCT02081521|"     Control of diarrhoeal disease requires a comprehensive package of preventive and curative     interventions. in Zambia, the Programme for Awareness and Elimination of Diarrhoea (PAED)     aims to reduce child deaths by combating diarrhoea in Lusaka province, Zambia. The behaviour     change component of the PAED programme seeks to change behaviours important for diarrhoea     prevention (handwashing with soap and exclusive breastfeeding) and improved treatment     outcomes (use of oral rehydration solution (ORS) and zinc in home management of child     diarrhoea).      The study aims to evaluate the feasibility of implementing a multiple behaviour change     community programme to tackle diarrhoeal disease in children under-five and to assess the     impact of this programme on practice of the target behaviours by caregivers of children     under-five. The research questions will be answered through a a two-arm cluster-randomised     trial (eight clusters per study arm).   "
92026|NCT02081508|"     The purpose of this research study is to investigate whether minimizing interference improves     memory in multiple sclerosis.   "
92027|NCT02081495|"     The purpose of this study is to support the qualification of a replacement manufacturing site     for DOXIL/CAELYX.   "
92028|NCT02081482|"     The occipital nerve stimulation (ONS) is used to treat patients with refractory primary     chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have     been suggested in particular a specific action on cerebral generators involved in different     types of primary headaches or a non specific action on pain modulatory network.      The aim of this study, using the chronic cluster headache as a model, is to determine the     changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary     chronic headache.   "
92029|NCT02081469|"     To evaluate the effectiveness and safety of tenofovir for different treatment duration in     preventing HBV relapse in patients with malignancies after receiving chemotherapy and     off-treatment of chemotherapy.   "
92030|NCT02081456|"     The purpose of this study is to investigate effects of soft tissue mobilization versus     therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical     sensitivity.   "
92031|NCT02081443|"     Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of     action associated with a greater reduction in ischemic events, including stent thrombosis, in     patients undergoing stent procedures who have not been pretreated with clopidogrel. In vitro     investigations have shown cangrelor to be associated with more rapid, potent, and consistent     platelet inhibition in patients on maintenance prasugrel therapy exposed to a re-loading dose     of prasugrel. However, if cangrelor exerts similar effects in ticagrelor treated patients     remain unknown. The aim of the present study is to evaluate the effects on platelet function     achieved after in vitro incubation with cangrelor in patients on ticagrelor maintenance dose     who receive a loading dose of ticagrelor.   "
92032|NCT02081430|"     The purpose of this study is to determine the immediate effects of cervicothoracic     manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and     cervical ROM.   "
92112|NCT02080390|"     The purpose of this research study is to evaluate the effects of the chemotherapeutic drug,     Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types     of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know     as to why this this happens. The investigators want to identify any factors that may lead to     the early detection, treatment and prevention of the cardiotoxicity (heart problem)     associated with this drug.   "
92046|NCT02081248|"     The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2)     Evaluation Study to understand barriers to implementation of ETRIC.   "
92033|NCT02081417|"     Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience,     has the potential to increase access to trauma treatment in underserved communities. This     could positively impact the lives of millions of people as 70% of adults in the U.S have     experienced a traumatic event and the consequences of trauma are devastating and far     reaching, including chronic and comorbid physical and mental health problems. The most known     consequences of trauma include post-traumatic stress disorder (PTSD) and substance use     disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for     co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required     to conduct SS, all the evidence comes from studies using trained clinicians to implement the     treatment, including social workers, psychologists, and psychiatrists. However, these     research findings do not generalize to underserved communities that lack mental health     professionals. Innovative approaches to treatment, such as peer-delivered services, are     required to meet the demand for care in underserved areas. While the benefits of     peer-delivered services have been well-documented in many areas, the value of peers in the     provision of trauma-treatment is unknown. A theoretical basis supports the potential for     peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient     bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome     and a typical result of peer-patient relationships.      Our research question is whether there is a difference between peer-led SS (PL-SS) groups and     clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs?      The investigators have three specific aims:        1. Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing          substance use and PTSD symptoms and improving coping skills, overall mental health and          physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in          improving outcomes.        2. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on          outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in          impacting outcomes in the PL-SS compared to CL-SS groups.        3. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for          peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.   "
92034|NCT02081404|"     Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population,     is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with     reflux symptoms have erosive esophagitis. The vast majority suffers from non erosive reflux     disease (NERD), a condition in which standard endoscopy fails to identify any mucosal breaks     and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of     NERD does not exist. Narrow band imaging (NBI) utilizes spectral narrow band filters     (incorporated into standard endoscopes) and helps to see abnormal areas not identified during     standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a     significant improvement over standard endoscopy for the diagnosis of NERD. The purpose of     this study is to accurately diagnosis non acid reflux disease by using a blue light (also     known as NBI)upper endoscopy technique.   "
92035|NCT02081391|"     The purpose of the study is to evaluate the efficacy of tapentadol oral solution, based on     the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after     initiation of investigational medicinal product in children and adolescents who have     undergone surgery that would produce moderate to severe pain during opioid treatment.   "
92036|NCT02081378|"     The design of a phase I, open label, dose finding study was chosen in order to establish a     safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed     or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and     ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.   "
92037|NCT02081365|"     Dental and health anxiety are common and potentially distressing problems, for both patients     and health care providers. Anxiety has been identified as a barrier to regular dental visits     and as an important target for enhancement of oral health-related quality of life. possible     groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and     evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that     could be easily implemented in dental healthcare settings.      A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental     procedures, and cognitive restructuring was developed. A randomized controlled trial was     conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion     (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1)     immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).   "
92038|NCT02081352|"     This study has been designed to help determine how safe and effective DermaPure™ may be in     treating hard-to-heal diabetic foot ulcers compared to the current standard of care.   "
92039|NCT02081339|"     Recent clinical introduction of anti-vascular endothelial growth factor agents may change the     clinical course of macular diseases, including age-related macular degeneration (AMD),     polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central     serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein     occlusion (RVO), diabetic macular edema (DME), and so forth.      Patients with such macular diseases are registered and and are followed up for 5 years with     appropriate treatment for each patient. By the analysis of the correlation between initial     examinations and final visual acuity, factors associated with good visual prognosis will be     elucidated.   "
92040|NCT02081326|"     The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can     confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on     repeat BCG vaccinations in long term diabetics showed specific death of some of the disease     causing bad white blood cells and also showed a short and small pancreas effect of restored     insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more     frequently to see if these desirable effects can be more sustained.      Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of     four years or receive a placebo treatment. The investigators hypothesize that each BCG     vaccination will eliminate more and more of the disease causing white blood cells that could     offer relief to the pancreas for increased survival and restoration of insulin secretion from     the pancreas.   "
92041|NCT02081313|"     This study aims at studying the natural history of Netherton syndrome (NS), to identify the     consequences of LEKTI deficiency on the immune system and to characterize new molecular     mechanisms involved in the disease.   "
92042|NCT02081300|"     The purpose of this study is to determine the safety and efficacy of an oral testosterone     undecanoate formulation for use as testosterone-replacement therapy in men with low     testosterone.   "
92124|NCT02080234|"     To evaluate the efficacy and safety of first-line gemcitabine, oxaliplatin, and asparaginase     (GELOX) with concurrent involved-field radiation therapy for patients in newly diagnosed     stage IE/IIE ENKTL.   "
92216|NCT02079038|"     The purpose of this study is to determine safety and effectiveness, as measured by changes in     pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following     treatment with the Totalis™ Direct Decompression System or Sham Surgery in patients with     lumbar spinal stenosis   "
92047|NCT02081235|"     Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported     to be associated with adverse outcome. Previous studies have reported that the incidence of     AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI     increase the patient mortality, intensive care unit stay and hospital stay. Previous studies     have reported several risk factors for AKI after congenital heart surgery, however,     perioperative variables including anesthesia-related factors have not been evaluated fully.     Therefore, the investigators attempt to find out independent risk factors regarding     perioperative variables.   "
92048|NCT02081222|"     Viscoelastic hemostatic assay has been reported to be superior to predict perioperative     bleeding in cardiac surgical patients compared with conventional blood coagulation test.     However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative     bleeding and transfusion requirements in pediatric patients who undergoing surgery for     congenital heart disease. Therefore, the investigators attempt to evaluate the predictability     of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion     requirements in pediatric cardiac surgical patients by comparing with conventional     coagulation test. The investigators also attempt to evaluate the correlation between ROTEM     parameters, platelet count, and results of conventional coagulation test results.   "
92049|NCT02081209|"     The purpose of this study is to compare the performance of a cryolipolysis system using     various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral     thighs.   "
92050|NCT02081196|"     The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous     fat layer reduction with an alternative treatment parameter.   "
92051|NCT02081183|"     This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)]     and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment     for patients with lupus nephritis. All patients will receive induction treatment with     cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the     maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free     follow-up. The anticipated time on study treatment is 12 months.   "
92052|NCT02081170|"     The purpose of this study is to determine the effectiveness of intravitreal autologous     platelet concentrate (APC) injection during the surgery for refractory macular holes.   "
92053|NCT02081157|"     This study is to assess the physician preference in the clinical performance of the GalaFLEX     mesh in soft tissue reinforcement during elective (cosmetic) plastic surgery to the breast,     in particular the breast lift mastopexy and breast reduction procedures   "
92054|NCT02081144|"     This is a pilot study to test the feasibility of conducting a text based smoking cessation     trial with Emergency Department patients who are smokers.   "
92055|NCT02081131|"     The aim of this study is to compare the two surgical approaches namely laparoscopic     pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and     pancreatic head cancers in terms of parameters like hospital stay, pathological radicality,     complication rate, peri-operative and post operative outcomes.   "
92056|NCT02081118|"     The purpose of this study is to determine the optimal dose or doses of HM11260C, when     administered once a month under the skin, to improve the control of blood sugar levels in     patients with early-stage type 2 diabetes mellitus (T2DM).   "
92125|NCT02080221|"     A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved     chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you     will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and     Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®.     Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with     the other 3 drugs is being investigated. Your doctors are studying the activity and side     effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.   "
92057|NCT02081105|"     Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP)     selection in ARDS patients. It is defined as the potential for the non aerated or poorly     aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes     to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at     the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the     repeated opening and closing of them during the breathing cycle, which is implicated in a     further lung inflammation. The gold-standard method for assessing lung recruitability is lung     CT scan. For economic and feasibility this technique cannot be used in routine. Therefore,     techniques that can be used at the bedside to measure lung recruitability are very well     known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve     generated by the ventilator is another reference method to approach lung recruitment. It can     be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this     setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a     regional approach. In a preliminary one-center study we found a significant negative     correlation between the amount of Vrec and the reduction in lung density measured by digital     CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous     result on a larger number of patients in a multicenter investigation.   "
92058|NCT02081092|"     The purpose of this study is twofold: to assess routine cat scan (CT) imaging as a biomarker     for removal of lipoprotein surfactant via lung lavage (where CT is the gold-standard imaging     technique for density quantification), and to utilize a novel UTE MRI protocol to similarly     quantify surfactant removal. This study will also serve to generate baseline scanning that     may aid in developing analytical tools to evaluate and treat specific lung regions of     patients with PAP.   "
92059|NCT02081079|"     This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir     (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis     C virus (HCV) infection as measured by the proportion of subjects with sustained virologic     response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after     discontinuation of therapy.   "
92089|NCT02080689|"     The influence of Decipher test on urologist and patient treatment plan choices immediately     post RP and at the time of PSA rise or BCR   "
92060|NCT02081066|"     The reverse cholesterol transport (RCT) pathway, which involves the centripetal movement of     free cholesterol from peripheral tissues, including the vessel wall, to the liver represent     the primary mechanism by which HDL protects against atherosclerosis and by which it may     induce plaque regression. Recent data reveal that the capacity of HDL to efflux cholesterol     from macrophages, a metric of HDL function reflecting the initial step of the RCT, is     clinically relevant, displaying a strong inverse association with both carotid intima-media     thickness and the severity of angiographic CAD; such observations were independent of HDL-C     levels.      In human, the Cholesteryl Ester Transfer Protein (CETP), represents a key protein of the RCT     pathway and mediates redistribution of neutral lipids between lipoproteins, has been     identified as a potential therapeutic target against atherosclerosis. It is known that CETP     activity correlates with HDL-C levels and represents a key modulator of the ability of whole     plasma to mediate free cholesterol efflux from human macrophages.      Recent studies showed that 23% of endogenous plasma CETP activity variability is explained by     plasma LDL-C (12.0%), HDL-C (6.4%) and TG (4.4%) whereas sex and BMI accounted together for     only 0.7% of its variability. Scoring patients for cardiovascular risk on the basis of their     plasma lipid levels (TC, TG, LDL-C and HDL-C), revealed that patients with high     cardiovascular risk (score ≥3) displayed a mean endogenous plasma CETP activity above 34%.     Therefore plasma CETP activity represents a potent indicator of cardiovascular risk in     patients with metabolic disorders since it integrates major independent risk factors.      The objective of this study is to decipher the relationship between CETP, HDL efflux capacity     and the development of atherosclerosis in humans in order to identify CETP as a potent     biomarker of atherosclerosis distribution.   "
92061|NCT02081053|"     To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor     ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic     lesions in the spine.   "
92062|NCT02081040|"     To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during     coughing and compare them to those with supratentorial brain lesion patients with dysphasia     and those with no dysphagia at a university affiliated rehabilitation department.   "
92063|NCT02081027|"     Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting     drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).   "
92064|NCT02081014|"     The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen     Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to     moderate hypoglycemia, a complication of diabetes.   "
92065|NCT02081001|"     The purpose of the study is to assess the safety, speed of absorption, and onset of action of     G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all     delivered via an OmniPod® infusion pump to patients with type 1 diabetes.   "
92066|NCT02080988|"     To assess coughing force during reflex coughing test in those with severe dysphagia and     severe aspiration and compare them to than those with stroke patients with no signs of     dysphagia/aspiration.   "
92067|NCT02080975|"     Successful radio frequency (RF) cardiac catheter ablation requires the creation of lesions by     delivering energy while maintaining adequate catheter contact with the endocardium.     Unfortunately, it is difficult to identify contact intraoperatively as a typical RF ablation     catheter lacks clear indications of contact. We propose to use the Boston Scientific     IntellaTip MiFi catheter to explore whether characteristics of the electrograms produced by     the mini-electrodes on the ablation tip could help confirm tissue contact. Using an     ultrasound catheter to define instances of clear contact and non-contact, we will determine     whether the micro-electrodes produce sufficient information to confirm catheter contact. We     propose that the MiFi catheter produces sufficient signal characteristics that can be used as     an effective surrogate for adequate tissue contact.   "
92068|NCT02080962|"     Radiotherapy is a treatment considered standard for non melanoma skin cancer. This     institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to     perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.   "
92069|NCT02080949|"     Brain metastases occur in 20-40% of patients with metastatic cancer. The standard treatment     is based on whole brain radiation therapy and local treatment of metastases as neurosurgery     or radiosurgery. However, many cases can not receive a standard local treatment, and local     relapse occurs in almost 50% of cases treated with only whole brain irradiation. There are     retrospective studies of increased radiation dose at the site of metastasis with     hypofractionated stereotactic radiotherapy (HSRT) with favorable results, but there are no     controlled studies regarding the safety of radiation dose in these situations. This study is     a phase I study to evaluate the maximum tolerance dose (MTD) with HSRT as a way to increase     the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for     surgery or RS.   "
92071|NCT02080923|"     The proposed study is a test of the feasibility and preliminary efficacy of a brief     motivational interview style intervention. The intervention will take place in the pediatric     emergency department of the Boston University Medical Center by a trained interventionist and     will follow an intervention manual developed by a team of dating abuse and brief intervention     experts. The study will involve two randomized groups of youth age 15-19: one group will     receive the intervention and the other will not. The study will compare changes in data from     baseline to 3- and 6-month follow-up for those in both groups. Outcomes including dating     abused related knowledge, attitudes about the use of violence to resolve conflict, and dating     abuse behavior (perpetration and/or victimization) will be assessed.      The hypothesis of this study is that youth who receive the intervention will show     improvements in dating abuse related knowledge, attitudes and behavior that are maintained     for 6 months, while those in the control group will show no similar change.   "
92072|NCT02080910|"     This is a randomized controlled trial with a 3-month psychoeducational program as     intervention, followed by a 3 month observational period. The purpose of this study was to     examine whether a psychoeducational program focusing on equipping caregivers with     problem-solving skills would improve caregiver's problem-solving abilities, their     psychological responses and caregiving resources, and would minimize the use of health and     social services among stroke survivors.   "
92073|NCT02080897|"     The purpose of this study is to evaluate the role of palliative surgery in improving Quality     of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS)     and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System -     Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for     resection of the primary tumour will be compared to those that are unable to have surgery.     Data collected from this questionnaire can highlight the benefits in patients' QoL who     receive palliative surgical resection, and whether these benefits surmount those who are not     treated with palliative surgery.   "
92077|NCT02080845|"     The Hershey Company is interested in investigating the effects of various chocolate beverages     on brain physiology and cognitive function. The main substances in the drinks that are known     to influence the brain are caffeine and related chemicals such as theobromine. Caffeine and     chemicals related to caffeine are all naturally occurring and all potentially alter brain     physiology. This study will evaluate changes in brain blood flow and cognition following the     consumption of drinks with various combinations of the Primary Ingredients. The study     proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an     attempt to understand the differential effects of these compounds in chocolate drinks.   "
92078|NCT02080832|"     The purpose of this study is to examine the role of brain MRI findings in predicting     treatment outcomes among individuals with cocaine dependence.   "
92079|NCT02080819|"     This project proposes to investigate the role of brain connectivity in the mechanism of     treatment response to dopaminergic medications in cocaine dependence.   "
92080|NCT02080806|"     Stroke patients with dysphagia have restrictive lung dysfunction and impaired cough response.     This pilot study was performed to determine if Mechanical Insufflation Exsufflation (MIE)     therapy can help recover impaired cough function.   "
92081|NCT02080793|"     This study will be based on two questionnaires        1. One specific questionnaire that has already been developed from social sciences          interviews conducted in men who have been treated for localized prostrate cancer, with a          good or intermediate prognosis. This questionnaire comprises 11 pairs of scenarios. Each          scenario gathers in a random manner, the modalities of 7 possible characteristics of the          management strategy for localized prostrate cancer, with a good or intermediate          prognosis:             -  the risk of death at 5 years (modalities: 5%, 15%),             -  the risk of impotence (modalities: 0%, 25%, 50%, 75%),             -  the presence of urinary leaks (modalities: no protection during the day, one               protection pad per day, several protection pads per day),             -  the duration and frequency of care provided (modalities: 2 days of care in your               whole life, 7 days of care in your whole life, 5 half-days of care per week for 8               weeks, every 3 months for 2 years then every 6 months for life),             -  ablation of the prostate (modalities: Yes, No),             -  the existence of possible treatments in case of aggravation or recurrence               (modalities: Yes, No),             -  the nature of the technology used (modalities: innovative technology, standard               technology).           The objective is to ask each participant of the study for each pair of scenarios, to          choose from the two scenarios (binary-choice survey), the scenario he prefers.        2. The Spielberger Inventory Trait scale to evaluate stable characteristics in the          propensity to anxiety in study participants.   "
92082|NCT02080780|"     The purpose of this study is to evaluate the drug-drug interaction potential of     clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.   "
92083|NCT02080767|"     The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure     to orthopox viruses.   "
92084|NCT02080754|"     Lung aspiration can occur when a rapid sequence induction of anesthesia is performed     (emergency and/or presence of at least one risk factor for regurgitation of stomach     contents).      The aim of this study is to assess the Sellick maneuver, which is recommended for patient at     high risk of aspiration of gastric content during induction of general anesthesia, despite     the lack of solid evidence of its efficacy and possible adverse effects The primary outcome     of this non inferiority study is the incidence of lung aspiration whether this maneuver is     effectively applied or sham.   "
92085|NCT02080741|"     This study will include 100 patients with Type 1 and Type 2 diabetes, split into 2 groups of     50 patients according to their behaviour type, and their adaptation to different factors of     stress encountered in their lives:        -  the first group will consist of patients with a characteristic Type A behaviour profile,          that is to say patients with a proactive, impatient behaviour pattern        -  the second group will consist of patients with a characteristic Type B behaviour profile          that is to say patients with a calm, slow behaviour pattern The objective is to know          if the different behaviour patterns are associated with distinct biological markers          likely to influence the evolution of the diabetes.      Participation in this study will be approximately 1h30, patients will participate ONCE ONLY:        1. they will answer simple questions about their disease and then complete 3 questionnaires          each with 14 items.        2. they will meet a clinical psychologist for an interview lasting approximately 45 minutes          recorded on an audio recorder. The consultation will be used to seek links between the          psyche and the disease.        3. they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the          morning.   "
92086|NCT02080728|"     The surgeon places the catheter in the thickness of the oblique internal and transverse     muscles at the moment the wall is closed, under visual control. A multiperforated catheter     whose length corresponds to that of the incision is chosed. The catheter will deliver one of     two products chosen at random: either ropivacaine or placebo.      This study will evaluate postoperative pain during the first 24 hours thanks to a recognized     indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also     be recorded, starting with the titration of morphine in the post-op room, and then the     consumption of classical analgesics in the nephrology department. These will only be given if     the VAS score is equal to 4 or above.      This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2%     versus placebo in continuous TAP block during the first 24 hours after the operation in     patients undergoing kidney transplant surgery.   "
92087|NCT02080715|"     In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy     subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are     identified by measurement of vigilance and cognitive performance as well as EEG measurements     during wake and sleep.        -  Trial with medicinal product   "
92088|NCT02080702|"     The aim of this non-interventional study is to evaluate the efficacy of a monofilament,     mid-term absorbable suture material (Monosyn®) for anastomosis performed in the     gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.      Postoperative complication rate, length of hospital stay, costs, time to perform the     anastomosis and handling will serve as secondary endpoints.      The question is addressed, whether a monofilament suture material is as effective as a     braided suture material for anastomosis construction within the gastrointestinal tract.   "
92091|NCT02080663|"     In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and     triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure     converts the wrist in a simple hinged joint but allows us to preserve a certain range of     motion in the wrist. One of the main disadvantages of PRC is the risk of developing arthritis     between the head of the capitate and the lunate fossa. The long-term follow-up of this     procedure has always been a reason for concern. The investigators set up this retrospective     study to evaluate the long-term results of the procedure in the investigators institution.      Also, the shape of the head of the capitate may play a role in the development of arthritis.     A more round shape could distribute the forces more equally and thus prevent the progression     of cartilage damage      The study hypothesis is:        -  PRC preserves range of motion and force in the long term (more than 10 years          postoperatively).        -  A more round head of the capitate is associated with an increased risk of developing          arthritis in the new joint.   "
92092|NCT02080650|"     This pilot study will aim to determine whether circulating tumor cells (CTCs) can be captured     using the novel cMET based ferrofluid. The primary objective of this pilot study will be to     describe the numbers of c-MET expressing cells that can be detected by the c-MET CTC capture     technique. These data will be separated by disease site. The investigator will also describe     the detection rates of both the c-MET CTC capture and the EpCAM CTC capture techniques in     each patient, also separated by disease site.   "
92093|NCT02080637|"     Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of     ambrisentan after Fontan surgical palliation of single ventricle heart defects.      Study activities and population group: Children undergoing Fontan surgical palliation for     single ventricle defects will be eligible for the study. Up to 20 subjects will be enrolled     (16 ambrisentan, 4 placebo) and will receive 3 days (3 doses) of ambrisentan starting on     post-operative day #1 upon returning from the operating room. Ambrisentan plasma levels will     be obtained at specified time points during treatment. Post-operative monitoring lines will     be used to measure effects of ambrisentan on hemodynamics and pulmonary / systemic     endothelial function.   "
92094|NCT02080624|"     Sturge-Weber syndrome (SWS) is a rare congenital neuro-cutaneous disorder considered as a     rare or orphan disease. SWS is characterized by a capillary vascular malformation (CM)     localized on the skin of the face, eyes and central nervous system. Given the localization     and the extent of the CM, children with SWS are particularly prone to developing severe     psychological problems. The standard treatment for CM is pulsed dye laser (PDL) although in     these cases whitening of the lesion is rarely achieved. Combining topical rapamycin, a     specific inhibitor of the mammalian target of rapamycin, with PDL is hypothesised to be a     good therapeutic option in these patients.   "
92162|NCT02079740|"     This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax     and how well they work in treating patients with solid tumors that have spread to other     places in the body. Trametinib and navitoclax may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
92095|NCT02080611|"     The investigators hypothesize that a garment-integrated sensing system will be able to detect     with clinical accuracy the position of the spine. The investigator will evaluate this using     healthy adult volunteers, who will don sensing garments and assume a series of spinal     postures. Concurrent with garment sensing, the participant's spine position will be measured     using a motion-capture system that uses reflective markers to detect positions of markers in     3D space.      The motion-capture system provides a gold-standard reference measure to which the sensing     garments will be compared. Because the investigators are evaluating the accuracy of the     sensing garment, it is only necessary that the investigator test the garments on participants     with subtly different body shapes. Healthy adult volunteers provide an adequate input to the     sensing signal.   "
92096|NCT02080598|"     The aims of this cross over prospective study are to demonstrate that smoking two cigarettes     do not change the gastric contents and volume in fasting volunteers.   "
92097|NCT02080585|"     The present study used a cluster-randomized controlled trial to evaluate the effects of a     computer-tailored, pedometer-based Physical Activity (PA) intervention delivered through the     Internet. An invitation e-mail with study information was sent to managers of 18 white-collar     workplaces. Eight workplaces consented to participate. All employees of a single workplace     were allocated at random to either the intervention or a waiting list control group, in order     to avoid contamination between employees receiving the intervention and those who were not     receiving the intervention. Subsequently, employees of the participating workplaces were     recruited by e-mail. Only Dutch speaking employees between 18 and 65 years old, who had     access to the Internet at work or at home, were eligible. Interested employees could sign up     by returning a confirmation e-mail to the researchers. On receiving this information, a     meeting was organized in each of the eight worksites to deliver all documents for baseline     measurement (T0) to the participants, including an informed consent form, a blinded     pedometer, an activity log and a self-administered questionnaire. During this meeting,     information was provided on how to use the pedometer, how to log PA activities and how to     answer the questionnaire. Moreover, the participants were asked to adhere to their usual PA     pattern throughout the baseline measurement. After one week, all measurement tools were     collected, and average daily step counts were calculated. At this point, participants in the     intervention condition received (1) a booklet with information on how to increase steps, (2)     a non-blinded pedometer, which they could use for three months, and (3) a username, a     password and the amount of average daily steps, calculated by the researchers, so that     participants could use this number when requesting the online computer-tailored step advice.     Participants in the control condition did not receive any of the above mentioned intervention     components. One and three months later, all participants again received a blinded pedometer,     which was worn for one week. When wearing the blinded-pedometer one month (T1) and three     months (T2) post baseline, intervention participants were allowed to also were the     non-blinded pedometer. Furthermore, the same self-reported questionnaire was used to measure     PA level at T1 and T2 in order to test the effectiveness of the intervention.   "
92098|NCT02080572|"     Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function,     which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable     movement sensors could be used to assess gait impairment in the patient's home hours after     treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the     effects of turning off deep brain stimulation on lower extremity and gait function over three     hours. This study will provide vital information about our patient worn system's ability to     detect changes in lower impairment over time, which could be used to assist with DBS tuning     for the lower extremities and gait in the future.   "
92104|NCT02080494|"     Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative     blood loss. This study is a prospective, randomized controlled trial investigating the use of     tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss     (>300mL) is expected.      The hypothesis of this study is that tranexamic acid will be associated with a decrease in     post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in     patients who have fracture surgery around the hip and knee.   "
92099|NCT02080559|"     This randomised, open-label, single-centre, descriptive study aims to investigate gene     expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB and     to relate this to vaccine reactions and to immune response.      160 healthy Caucasian infants aged 8-12 weeks (at time of first visit) who have not yet     received their routine infant immunisations will be recruited. Participation in the study     will be limited to to Caucasian infants (defined as having two Caucasian parents). This is so     that baseline variability in gene expression data which is to some degree affected by     ethnicity is reduced.      Participants will be randomised to either a 'test' group or 'control' group depending on what     4CMenB schedule they receive, with 80 infants in each.      All participants will receive the usual paediatric immunisations according to the UK national     immunisation schedule. In addition, participants in the test groups will receive 4CMenB at 2,     4 and at 12 months while those in the control groups will receive the same vaccine at 5, 7     and 13 months. Blood samples will be taken from each infant at specified time points before     and after vaccination to address the objectives of the study.      In addition, oro-pharyneal swabs will be obtained around different vaccination timepoints to     investigate the effect of 4CMenB vaccination on the oro-pharyngeal Neisseria microbiome.   "
92100|NCT02080546|"     Purpose of this randomized control study is to determine if the mode of electrothermal     colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic     hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing.     Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or     standard cut/coag form of electrothermal energy.      Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be     used to examine the association fo dehiscence with proposed risk factors in the retrospective     part of the study. In the randomized controlled trial, depth of thermal injury will be     compared between the two groups, and a chi-square test will be used to test for a difference     in clinical outcomes between the two groups. There is little risk associated with this study     above the normal surgical risks; however, the V mode has not been previously been studied for     its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but     all samples will be de-identified and given a unique study number, and only individuals     directly involved in the study will be given access to the study information.   "
92109|NCT02080429|"     Obesity rates in reproductive aged women in the United States are rising. It is now     universally accepted that obesity is associated with many adverse pregnancy outcomes and     post-operative complications following cesarean section. Recent studies have also shown an     increased rate of cesarean section in obese women, adding to the already elevated rate of     complications and adverse outcomes. Given the increased a priori risk for obese patients, it     is vital that the investigators reexamine management practices routinely used for normal     weight women in this specific high-risk population. Passive descent has been shown to     increase the spontaneous vaginal delivery rate in non-obese women; however, high quality     studies have never been performed in obese women. the investigators hypothesize that passive     descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with     regional anesthesia. This study will randomize women to passive descent for ninety minutes or     active pushing upon entry into the second stage. Further, given that passive descent is     widely accepted in the midwifery literature and clinical practice, the investigators     anticipate that a high-quality study in the physician literature could increase the dialogue     between practitioners and lead to development of best practices in this high-risk population.   "
92101|NCT02080533|"     Pulmonary arterial hypertension (PAH) is a chronic illness characterized by increased     pulmonary pressures resulting in right heart failure and premature death. Common symptoms     that impair quality of life and functioning are dyspnea, fatigue and sleep disturbance. This     trio of symptoms is highly prevalent and forms a symptom cluster (2 or more symptoms that     co-occur) in PAH. From a biological, proinflammatory cytokines are implicated in dyspnea,     fatigue and sleep disturbance; there is activation of the sympathetic nervous system (SNS)     and an inherent inflammatory process in PAH that contributes to the pathophysiology, but the     link to this symptom cluster has not been investigated. One novel, treatment for symptom     clusters is slow-paced respiration therapy using the FDA-approved device, RESPeRATE. The     device contains headphones and a sensor that attaches to the chest to detect inhalation and     exhalation. Musical tones synchronize with the respiratory cycle to slowly guide the user to     decrease respirations. RESPeRATE moderates effects of the SNS; lowers blood pressure;     improves functional capacity and ejection fraction; and significantly decreases pulmonary     pressures in left heart failure. The investigators will enroll 10 women with PAH to use the     RESPeRATE device to perform slow-paced respiration for 15 minutes per day for 8 weeks to     determine the feasibility and effects on the SNS and inflammatory activity and the symptom     cluster. The investigator's overall hypothesis is that, as compared to baseline, after eight     weeks of therapy women with PAH who receive slow-based respiration therapy will have lower     SNS activity and inflammatory levels, and improved dyspnea, fatigue and sleep disturbance.   "
92102|NCT02080520|"     The potential for nattokinase to thin blood and to reduce blood clotting by positive     antithrombotic and fibrinolytic effects presents a unique opportunity to safely study such     effects on cardiovascular disease and cognition. Unfortunately, such studies of     antithrombotic and fibrinolytic pathways of prevention have been limited due to lack of safe     compounds and the adverse reactions associated with current agents such as Coumadin.     Nattokinase, an over-the-counter supplement used for cardiovascular health, is the most     active functional constituent of natto, a fermented soy product. Natto has been consumed     primarily by the Japanese for over 1000 years, a population with one of the lowest risks for     cardiovascular disease and dementia. Cardiovascular disease and dementia remain the most     challenging age-related health risks of the 21st century for Americans necessitating     development of further effective preemptive strategies. Whether reducing the propensity for     thrombus formation and/or increasing fibrinolytic activity can prevent the progression of     atherosclerosis and cognitive decline has not yet been determined.      Using nattokinase under primary prevention conditions, the investigators propose to conduct a     randomized, double-blinded, placebo-controlled trial to determine whether decreasing     atherothrombotic risk can reduce the progression of atherosclerosis and cognitive decline.     The investigators propose to randomize 240 healthy non-demented women and men to nattokinase     supplementation or to placebo for three years. The primary trial end points will be     measurement of carotid arterial wall thickness and arterial stiffness, early changes of     atherosclerosis that can be measured safely by non-invasive imaging techniques. The secondary     trial end point will be ascertained through change in cognition measured by a     neuropsychological battery. In addition, biochemical blood measurements and in vitro studies     will be conducted to compare the effects of nattokinase relative to placebo on blood     coagulation and thrombus break-down capabilities, blood flow properties, inflammation and     inflammatory activation of endothelial cells that line blood vessels.      At the conclusion of this trial, the investigators expect to have sufficient evidence as to     whether reducing the propensity for thrombus formation and/or increasing fibrinolytic     activity can prevent the progression of atherosclerosis and cognitive decline. These results     will provide novel and important data that will be informative concerning primary prevention     through the atherothrombotic pathway. Providing evidence for a reduction in atherosclerosis     progression and cognitive decline with nattokinase is likely to shift the current clinical     paradigm for the prevention of these chronic age-related processes. In addition, such     evidence will serve to create a new field of discovery and opportunity for prevention of     cardiovascular disease and dementia.   "
92105|NCT02080481|"     An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been     recently developed to guide clinicians in performing ultrasound guided nerve blocks. This     system helps the clinician to align the needle with ultrasound beam while performing an     ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing     efficient needle movement while having improved needle shaft and tip visualization. This is a     disposable system specifically designed for improving success rate of ultrasound guided block     and patient safety.      This study will be done with patients having elective knee surgery and a femoral nerve block     with a catheter. The nerve block procedure will be performed under ultrasound guidance to     help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently     developed to try to improve needle guidance in the ultrasound guided nerve block procedure.     This study will determine whether femoral nerve block procedures performed under ultrasound     guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound     guidance and a conventional block needle. The study will also determine whether the     InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure,     reduces the cost of the procedure, increases the procedure success rate, and improves     ultrasound visibility of the needle.      Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus     (TM) needle guidance system or ultrasound guidance with a conventional block needle. After     surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while     awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain     treatment satisfaction and a questionnaire about recovery.   "
92106|NCT02080468|"     The primary objective of this study is to assess the effect of ethinyl estradiol     (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK)     of lomitapide and 2 primary metabolites, M1 and M3.   "
92107|NCT02080455|"     The primary objective of this study is to assess the effect of atorvastatin, a weak     cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2     primary metabolites, M1 and M3.   "
92108|NCT02080442|"     The study will involve direct knowledge translation of a laboratory-based study of balance     training for patients with COPD, first to the investigators PR program and then, after     disseminating the results, this approach could be used to impact on clinical practice in any     PR program.   "
92110|NCT02080416|"     The goals of this study is to determine if nelfinavir can target Epstein-Barr virus (EBV) and     Kaposi sarcoma-associated herpesvirus (KSHV) in patients with certain cancers.   "
92113|NCT02080377|"     The aim of this open label feasibility study is to determine recruitment rates to a     randomised trial of glibenclamide compared with insulin (both in addition to maximum     tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This     feasibility trial will inform the design of a future substantive multicentre trial to test     the hypothesis that combination therapy with glibenclamide and metformin could reduce the     number of pregnant women with GDM who require insulin and would be superior to metformin and     insulin in terms of acceptability and cost effectiveness.      Women with GDM who have failed monotherapy with metformin will be recruited and randomised     to either receive glibenclamide (test arm) or standard care with insulin, both in addition to     their maximum tolerated dose of metformin. Patients will be recruited from three of the     antenatal clinics.      This is a feasibility study in preparation for a large multicentre randomised trial to test     the hypothesis that the addition of glibenclamide to metformin (combination therapy) could     reduce the number of pregnant women with gestational diabetes mellitus requiring insulin,     without compromising glycaemic control or other clinical outcomes. The investigators     hypothesise that combination therapy with metformin and glibenclamide is likely to be     preferable to metformin and insulin in terms of acceptability and cost.   "
92114|NCT02080364|"     This is a study to evaluate the efficacy and safety of azeliragon in patients with mild     Alzheimer's disease. Patients will receive either azeliragon or placebo with a patient's     participation lasting approximately 18 months.   "
92115|NCT02080351|"     This research study is designed to investigate the effects of a simple cognitive task (a     memory reactivation cue following by playing the computer game Tetris) on flashbacks and     other post-traumatic stress symptoms after a road traffic accident. Patients presenting to a     hospital emergency department soon after a road traffic accident will be randomly allocated     to either the simple cognitive task intervention or usual care. Participants will be followed     up at one week and one month. It is predicted that participants given the simple cognitive     task intervention will develop fewer flashbacks and less severe clinical symptoms than those     who are not. This will inform the potential future development of a simple technique to     prevent distressing psychological symptoms after a traumatic event.   "
92116|NCT02080338|"     The purpose of this study is to compare the 0.018-inch and 0.022-inch bracket slot systems to     determine which is more effective for orthodontic treatment .   "
92129|NCT02080169|"     It is well known that ICU patients need sedation. Now no ideal sedation drug existed and     every sedation drug has its advantage and disadvantage,so combined sedation may use the     advantage and avoid the disadvantage of the sedation drug according to the     patients'condition. Until now, there is rare study about the combined sedation or sequenced     sedation of different sedation drug.The purpose of the study is to explore the value of     combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU,     so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the     appropriate sedation not under sedation or over sedation,reduce the incidence of delirium,     reduce the adverse event of sedation.   "
92130|NCT02080156|"     Investigators assume that continuous positive airway pressure (CPAP) therapy can reduce the     mortality, stroke rate and secondary coronary surgery in CAD with obstructive sleep apnea     (OSA) patients after percutaneous coronary intervention (PCI) or coronary artery bypass     grafting (CABA) during postoperative follow-up of 3 years.   "
92131|NCT02080143|"     A disposable, air-activated, adhesive backed heat patch is being evaluated.   "
92132|NCT02080130|"     The purpose of this study is to determine which of two different preparations of probiotics     is effective in the treatment of acute viral diarrhoea in children.   "
95618|NCT02034565|"     The purpose of this study is to assess the oral bioavailability of Apixaban solution     formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment     A, 10 mg as 2 x 5 mg tablets) in healthy subjects.   "
92117|NCT02080325|"     This study aims to investigate the mechanistic processes involved in protein-induced     satiety/satiation during weight loss in humans.      Thsi study will investigate:        -  How do high-protein weight loss (HPWL) diets rich in meat or soya based protein sources          impact on profile of 'motivation to eat' both within a day and between days ?        -  Do biomarkers of satiety alter differentially on meat or soya HPWL diet, as measured by          monitoring alteration in plasma amino acids and gut-related hormones ?        -  How does a vegetarian and meat-based weight loss diet impact on nitrosamine excretion in          faecal samples, as an indicator of faecal toxicity?      Previous work has indicated that high-protein (30% protein) weight loss diets are more     satiating (produce less hunger) than normal protein WL diet (15% protein) or a diet     supplemented with few amino acids. In previous work, a mixed source of protein has been used,     mainly from meat (beef, chicken, fish). These types of diets have been criticised because of     the potential negative side effects, including our own work on gut health. It might be that     alternative vegetable sources of protein could fulfil the diet remit, to be satiating and yet     still allow weight loss, and maintain a healthy gut.      Design -within subject, randomised cross-over design after day 3. Each subject acts as their     own control and will receive each treatment. 18-20 subjects to participate.      Length of time - Conduct the two nutritional interventions over a period of 14 days, in order     to reduce effects due to an acute change in nutritional intake.      PROTOCOL Days 1- 3 - Normal Protein Maintenance diet (NP- MTD, 3 days)        1. st ARM Days 4-17 - randomised to High Protein-Weight loss-Meat (HP-Soya,14 days),        2. nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya (HP-meat,14 days),   "
92118|NCT02080312|"     This is a pilot study of patients with clinical symptoms of Ménière's disease using injection     of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear     structures.      The goal is to reproduce imaging findings described by non-United States (US) institutions,     improve on image quality with decreased scan time and evaluate the dynamics of the contrast     movement into the inner ear structures.   "
92119|NCT02080299|"     Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical     practice, but concerns have been raised regarding periprocedural complications like e.g.     myocardial injury, stroke or acute kidney injury. Remote ischemic preconditioning (RIPC) with     upper limb ischemia/reperfusion provides perioperative myocardial protection in patients     undergoing elective coronary artery bypass surgery. The present study assesses protection of     heart, brain and kidney by RIPC in patients undergoing TAVI. The study also addresses safety     and clinical outcome.   "
92120|NCT02080286|"     The present study aims to compare the relative therapeutic efficacy of prism adaptation     therapy combined with real versus sham tDCS. The investigators will test the hypothesis that     the magnitude and duration of neglect improvement will be increased when prism therapy is     combined with real tDCS compared to sham tDCS.      A second objective is to test whether individual differences in baseline clinical or brain     imaging measures can predict: 1) neglect severity or 2) inter-individual differences in     patients' therapeutic response.      A third goal is to use brain imaging to characterize the patterns of neural change induced by     the intervention to identify brain structures that mediate therapeutic response.   "
92121|NCT02080273|"     The objective of this randomized, single center, parallel clinical research study is to     evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste,     Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and     dental plaque in adults.   "
92122|NCT02080260|"     This study tests regorafenib as a single agent in the treatment of metastatic pancreatic     cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis     for these patients is particularly grim, no other standard treatment options exist, and novel     approaches are desperately needed.   "
92123|NCT02080247|"     A randomized controlled trial that compared the use of two topical zinc oxide based diaper     rash products in a structured care regimen for the treatment of IAD in hospitalized adults     and older children.   "
92126|NCT02080208|"     Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who     need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in     respiratory weaning. Now new devices can be used. They provide high flow oxygen with     different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2),     allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of     this study is that the high flow oxygen enable more efficient oxygen administration than     conventional oxygen. In addition, it would improve the effectiveness of the ventilation of     the patient, through flushing the dead space.   "
92127|NCT02080195|"     The main goal of the study is to determine if bone marrow transplant (BMT) from a less     specific pool of donors in combination with high dose cyclophosphamide can induce remission     of refractory systemic lupus erythematosus.   "
92128|NCT02080182|"     In different studies, it has been shown that antioxidant utilization has favorable     therapeutic effects not only on control of acute symptoms but also on prevention of delayed     problems from acute and chronic pyelonephritis.      According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and     side effects of similar or either less than placebo, this study was designed to evaluate the     efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a     triple-blind placebo controlled study on a population of 64 patients 1-16 years old that have     definite or probable diagnosis of acute pyelonephritis in Mofid hospital.      After randomization, patients will be given acetylcysteine or placebo with dosing according     to their weight. Results of treatment are evaluated according to serum procalcitonin, C     reactive protein and leukocyte count before drug prescription (baseline) and 5 days after     drug prescription. Side effects are also recorded in both groups. Patients will be receiving     their routine antimicrobial drugs in addition to acetylcysteine.   "
92133|NCT02080117|"     It is required to establish an adequate definition of delayed graft function in deceased     donor kidney transplantation. We attempt to compare various definitions of delayed graft     function and find the definition that can predict graft function survival best in deceased     donor kidney transplantation.   "
92134|NCT02080104|"     Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour     following vaginal delivery: A randomised controlled trial   "
92136|NCT02080078|"     This study is to determine the use of theophylline in patients with NSCLC and advanced solid     malignancies and whether treatment with theophylline will help lower or diminish the side     effect of diarrhea in patients taking erlotinib. Patients will be enrolled in one of two     parts of the study to verify the lowest dose of theophylline that is effective and the     highest dose of erlotinib that can be tolerated with theophylline. If this study shows that     theophylline is able to inhibit erlotinib induced diarrhea, it will help demonstrate that     patients using the tyrosine kinase inhibitor (TKIs), erlotinib, can use it effectively at     higher doses without experiencing severe diarrhea.   "
92137|NCT02080065|"     The incidence of acute kidney injury after liver transplantation has been reported to be 17     to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to     identify and prevent reversible risk factors for acute kidney injury after liver     transplantation. Previous studies have reported several preoperative clinical risk factors,     but preoperative medication and intraoperative colloid administration and hemodynamic     parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk     factors and develop simplified clinical risk scoring model.   "
92138|NCT02080052|"     Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance     (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the     procedure has high false-negative rates. This represents a daily problem for urologists     managing the disease, creates uncertainty and emotional stress for patients, and initiates a     cascade of repeat testing and biopsies which also burden the investigators healthcare system.      The investigators believe that prostate biopsy can be improved by using a new biopsy     paradigm. The investigators plan to perform MRI-guided prostate biopsies with     robot-assistance for orienting a needle-guide through which the biopsy is taken. The     combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity     compared to regular TRUS biopsies.      The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety.     The needle-guide robot is an investigational device developed in their Urology Robotics     Laboratory.   "
92139|NCT02080039|"     In this study the following hypotheses will be tested:      Electrical stimulation of the gluteal muscle (buttocks) leads to        1. an increase in the thickness of the gluteal muscle        2. a decrease in the thickness of the fat of the buttock area        3. a change in the distribution of the middle and maximal seating pressure to a more          consistent pressure        4. an increase in well-being of the patients.   "
92140|NCT02080026|"     Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious     diseases. With approximately 627.000 deaths a year, there is desperate need for an effective     vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve     the level of efficacy necessary to eliminate malaria. It has been shown previously that     healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine,     medicine that prevents malaria, are fully protected against a subsequent malaria challenge.     This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it     a good model to identify what immune responses protect against malaria, to further guide     vaccine development. In this study we will use CPS-immunization to induce protection against     malaria in healthy subjects and then analyse their immune response to a malaria challenge     infection.   "
92141|NCT02080013|"     our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized     study.   "
92142|NCT02080000|"     The aim of this study is to investigate whether the use of a simple feature on the 12 lead     electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant     benefit to patient management. More specifically it is to investigate whether using the     R-wave in V1 of the surface ECG to guide the timings between left (LV) and right ventricular     (RV) pacing improves response to Cardiac Resynchronisation Therapy.   "
92143|NCT02079987|"     The purpose of this study is to find out if a new way of helping patients after they leave     the Emergency Room (ER) improves their quality of life. The purpose is also to find out if     the new way of helping decreases ER use.   "
92144|NCT02079974|"     Endometriosis is a chronic inflammatory disorder leading to painful periods, pain with     intercourse and infertility. The available treatment options to alleviate pain involve mainly     hormonal treatments and surgery. All current hormonal treatments are effective but disrupt     the normal variations in reproductive hormones which prevent ovulation, and thus pregnancy.     Statins, a group of cholesterol lowering drugs, have anti-inflammatory properties which may     be helpful also for the pain related to endometriosis. The investigators plan to undertake a     pilot study of 10 patients with endometriosis who will take pravastatin sodium together with     coQ10, which is inhibited by statins, for a period of 3 months. If this pilot study shows     that the statin treatment may decrease pain symptoms in endometriosis, then the investigators     plan to undertake a larger study to further investigate this matter.   "
92145|NCT02079961|"     The study on dairy value chains that will be conducted in Northern Senegal tests whether a     health-related product (micro-fortified yogurt) targeted to children can be provided through     the logistics of an existing value chain, and whether in return this can be leveraged to     enhance the reliability of producers supply within this value chain. This study is conducted     with a local milk factory, a recently established social enterprise, striving to produce     dairy products with the milk collected from several hundred semi-nomadic small-scale     producers in northern Senegal. This study tests: (i) whether the logistic created to collect     milk in a remote area can be leveraged to deliver fortified yogurts to infants within its     suppliers households; (ii) whether such products effectively help improve the nutritional     status (anemia) of these children; and (iii) whether these health services encourage     suppliers (and in particular women) to increase their milk delivery to the milk factory.   "
92146|NCT02079948|"     This study will be the first to test whether a selected anti-inflammatory agent,     methotrexate, reduces inflammation in a human body, improve cognitive and physical function,     and reduce pain levels in older adults at risk for functional decline, due to systemic     inflammation.   "
92311|NCT02077803|"     The purpose of this study is to assess the bioequivalence (similarity of the drug amount in     blood among the formulations) of the fixed dose combination (two components combined in one     tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/1000     mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR     tablet (4 x 500 mg) in healthy fed participants.   "
92147|NCT02079935|"     Eating disorders includes anorexia nervosa, bulimia nervosa, binge eating and other     specified feeding or eating disorder (OSFED). Common to all is the intensively occupation to     control food intake, body image and body weight. Most people with this kind of disorder don't     reach for professional help, or there may be more than 4 years before they do. Cognitive     behavior therapy is the foremost method of treatment of eating disorders, but up to 30-50% of     the patients don't respond to this. The investigators find it important to identify science     based alternatives of therapy, as this may reduce the health concern, and broaden the choice     of therapy methods. A former study by Sundgot-Borgen et al in 2002, found guided physical     activity to reduce symptoms of bulimia nervosa just as good as the traditional cognitive     therapy.      The primary objective of the project is to see whether the combination of physical activity     and nutritional education is more effective in treating eating disorders, than cognitive     therapy.      Secondly, the investigators want to see whether there are any differences with regard to the     individual satisfaction of treatment method, and to associated costs.   "
92148|NCT02079922|"     PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary     purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and     pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.   "
92149|NCT02079909|"     The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and     ADCS-CGIC.      The secondary objectives are:        -  To evaluate the safety and tolerability of T-817MA measured by clinical safety          laboratories, physical examinations, ECGs and solicitation of adverse events.        -  To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric          Inventory (NPI) and Mini-mental State Examination (MMSE).   "
92163|NCT02079727|"     The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4&6     sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee     osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active     comparator.   "
92164|NCT02079714|"     The STREAM Study is a prospective longitudinal observational outcomes study that will examine     the reliability, validity and responsiveness of the PROMIS tools for clinical research     following orthopaedic trauma.   "
92165|NCT02079701|"     The primary objective is to determine the clinical benefit of employing the 23-valent     pneumococcal vaccine among US military trainees. Secondary objectives include:        -  determining the etiology of clinical pneumonia among U.S. military trainees;        -  comparing the serotype distribution of S. pneumoniae (Sp) isolates recovered from          vaccinated and nonvaccinated trainees diagnosed with pneumonia; and        -  comparing days lost from training due to pneumonia or acute respiratory disease for          vaccinated and nonvaccinated subjects.   "
92150|NCT02079896|"     Dialysis patients regularly suffer from anemia which may be caused by various contributing     factors, alone or in combination, including blood loss, low erythropoietin and iron     sequestration. In most patients, the anemia is responsive to treatment with erythropoietin or     other erythropoiesis stimulating agents (ESA) alone or in combination with intravenous (i.v.)     iron. In about 10% of patients however, the anaemia does not respond appropriately to this     standard treatment and high to very high doses of ESA and i.v. iron are used to maintain     acceptable hemoglobin concentrations. In these patients, hepcidin was identified as a     causative factor leading to anemia of chronic disease with functional iron deficiency and     ESA-hyporesponsiveness.      The Spiegelmer lexaptepid pegol (NOX-H94) offers a hepcidin-specific approach to the     treatment of anemia of chronic disease. The safety and the activity of lexaptepid pegol are     supported by data from healthy subjects and patients with multiple myeloma or lymphoma. The     present study in dialysis patients with functional iron deficiency and ESA-hyporesponsiveness     is conducted to demonstrate the safety of lexaptepid pegol in this population, to investigate     its pharmacokinetic (PK) and pharmacodynamic (PD) profiles and its efficacy in increasing     haemoglobin (Hb) in dialysis patients.   "
92151|NCT02079883|"     This is a multicenter, prospective, observational, Phase 4 study that will assess clinical     outcomes and safety of JETREA® administered in a real-world setting for the treatment of     symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in     1500 patients recruited across approximately 120 USA retina sites.   "
92152|NCT02079870|"     This trial is conducted in Europe. The aim of the trial is to investigate the effect of     semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride     metabolism and gastric emptying in obese subjects compared with placebo.   "
92153|NCT02079857|"     The objective of this study is to test the efficacy of a symptom management treatment     strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with     Irritable Bowel Syndrome (IBS) in adults.   "
92154|NCT02079844|"     The purpose of this study is to determine whether cognitive impairment associated with     schizophrenia is attenuated by add-on roflumilast administration to second generation     antipsychotics (SGA) in participants with stable schizophrenia.   "
92155|NCT02079831|"     The aim of the proposed study is to provide important data on weight loss efficacy in     overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet     utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The     investigators hypothesize that the higher protein diet will result in greater weight loss due     to increased satiety and better dietary adherence.   "
92156|NCT02079818|"     The primary objective of this study is to gather post market data on the Penumbra Ruby Coil     System in the treatment of visceral artery aneurysms and arteriovenous malformations. This     study is a prospective, multi-center study of patients with visceral artery aneurysms and     visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data     for each patient are collected up to 12 months post-procedure for the study.   "
92157|NCT02079805|"     Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects     of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with     essential hypertension complicated by type 2 diabetes mellitus   "
92367|NCT02077075|"     This research is collecting data to determine the benefits of a web-based wellness program     designed to improve the health and well-being of individuals in the workplace. Participants     will be invited to participate in a web-based Healthy Weight Program. The program is designed     to optimize health and wellbeing by promoting physical activity and healthy eating.   "
92158|NCT02079792|"     Chronic Rhinosinusitis (CRS) is a common disorder of the nose characterized by stuffy nose,     discoloured nasal discharge, sinus congestion or pressure and decreased sense of smell,     present for over twelve weeks. Anti-inflammatory steroid medication is often used to treat     sinus inflammation in CRS. These steroids are sometimes delivered using a spray device that     creates a mist to deliver steroid medication deep into the nose. However, the distribution     and efficacy of sprayed medication can be affected by the position of the patient's head.     This study aims to determine which of two head positions is best for delivering steroid to     the sinuses.   "
92159|NCT02079779|"     Stroke is the principal cause of permanent disability within the investigators population.     This incapacity justifies an intensive and prolonged multidisciplinary rehabilitation, which     can be optimized by robotics.      The investigators team has developed a robot designed to rehabilitate the upper limb. This     robot allows the patient to perform active, passive, or assisted exercises. The system is     also able to assess movement quality and to provide a feedback to the patient and the     therapist via a graphical interface. This therapy is designed to improve functional recovery     of patients, and then their quality of life.      Few quality studies have evaluated the efficacy of robotic assisted therapy in patients at     the acute stage of rehabilitation (< 3 months post stroke) when most improvements are     observed.      Thus, the aim of this study was to objectify the effectiveness of robotic-assisted     rehabilitation in the acute stage after stroke by evaluating the 3 fields of the ICF     (International Classification of Functioning, Disability and Health) and performing a     prospective multicenter randomized controlled single blind trial. In this study, 60 stroke     patients will be recruited and randomized into two groups. All patients will receive a     similar classical rehabilitation as a basis. Patients of the control and experimental groups     will receive a supplement of classical rehabilitation and robotic-assisted therapy,     respectively.   "
92160|NCT02079766|"     This study will explore the use of 18F-AV-1451 as a biomarker for chronic traumatic     encephalopathy (CTE) and examine the relationship between clinical presentation and tau     deposition.   "
92161|NCT02079753|"     Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was     designed to compare oxygen saturation and patient satisfaction with a portable oxygen     concentrator or with a combined system consisting of a fixed device with continuous flow     oxygen dispensation and a portable device with pulse dispensation for ambulation.      Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4     years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used     the combined system, consisting of a fixed oxygenation system and a portable system for     ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a     stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while     walking were determined at baseline. Patients were maintained on the previous combined system     for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2     over 24 hours was calculated by the software in the oximeter, and compliance was monitored   "
92166|NCT02079688|"     Atopic dermatitis (AD) is a chronic or chronic recurring inflammatory skin disorder. Patients     suffer from eczema and often severe pruritus on the affected skin, as well as from frequent     complications and secondary infections. Next to a genetically predetermined defect in     epidermal barrier function and vegetative dysfunction, AD arises from an upregulation of     Th2-modified immune responses inducing increased IgE-antibody production, cytokine secretion     and subsequently, local inflammation.      Although standard therapies of AD, modern topical corticosteroids, show a better ratio of     therapeutic effects to side effects, they retain a moderate acceptance due to their     non-specific action, strict compliance requirements and possible adverse effects. As a newer     alternative, calcineurin inhibitors show fewer side effects but raise concerns regarding long     term risks including the possibility of skin carcinogenicity. Therefore, medical need remains     for novel therapies for this major public health problem, directed in particular at specific     early disease-causing mechanisms and/or molecular targets, with an improved efficacy, safety     and compliance.      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting     early disease-causing mechanisms are a promising approach for the treatment of AD.      The transcription factor GATA-3 represents the key regulatory factor of Th2-driven immune     responses. It is indispensable for the differentiation and activation of Th2 cells; it     integrates Th2 signals and induces Th2 cytokine expression. The investigational product SB011     contains the DNAzyme hgd40 that targets GATA-3. By cleaving GATA-3 mRNA hgd40 reduces     specific cytokine production and thereby reduces key features of allergic airway     inflammation.      DNAzymes are completely generated by chemical synthesis and can be produced under Good     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,     i.e. they are not generated by use of any living organism including cell culture or bacteria.     The molecules are highly water-soluble and will be applied as a water/oil/water (W/O/W)     formulation since multiple emulsions have been shown to protect the active ingredient from     degradation on the skin and have penetration enhancing properties in comparison to other     carrier systems.      This proof-of-concept study will evaluate the efficacy, safety, tolerability,     pharmacokinetics (PK), and pharmacodynamics (PD) of the topical formulation SB011 containing     2 % hgd40 twice daily (BID) in patients with mild to moderate atopic eczema.   "
92167|NCT02079675|"     The purpose of this study is to determine the efficacy and safety of different doses of     SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with     non-constipation.   "
92168|NCT02079662|"     The goal of this behavioral research study is to look at the relationship between lifestyle     factors and cancer-related outcomes, such as the risk of the disease coming back, patient     quality of life, physical functioning, and bodily reactions (such as hormones and immune     function).   "
92169|NCT02079649|"     The purpose of this study is to evaluate two investigational ophthalmic solutions for     reduction in ocular redness in subjects with allergic conjunctivitis.   "
92170|NCT02079636|"     The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in     combination with another anti-cancer drug in participants with NSCLC that is advanced or has     spread to other parts of the body (stage IV). The study will also investigate how the body     processes the combination treatment and how the study drug affects the body. The study will     also collect disease-related symptoms and participant-reported pain related to NSCLC.   "
92171|NCT02079623|"     The aim for this study is to implement electroporation therapy (NanoKnife) treatment for     patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be     given in addition to standard chemotherapy.   "
92266|NCT02078388|"     The purpose of this study is to identify the genetic variants that are associated with higher     risk of doxorubicin-induced cardiotoxicity can contribute towards developing a predictive     algorithm comprising both clinical and genetic factors to select patients who should avoid     treatment with anthracyclines.      Hypothesis of this study is certain functional variants in genes that encode for metabolizing     enzymes and/or targets in the doxorubicin pharmacology pathway may increase the risk of     doxorubicin-induced cardiomyopathy   "
92172|NCT02079610|"     The purpose of this study is to determine whether upregulating the left amygdala during     positive autobiographical memory recall via real time functional magnetic resonance imaging     neurofeedback will lead to an improvement in clinician administered ratings of depressive     symptoms. The investigators predict that patients with major depressive disorder receiving     left amygdala neurofeedback will increase their amygdala response during positive     autobiographical memory recall compared to those receiving control feedback from a region not     involved in emotional processing and that this ability will be associated with clinically     significant improvement.   "
92173|NCT02079597|"     -  With the underlying study the investigators address the question if Ninjurin-1 (Ninj1)          expression is altered in patients with systemic inflammatory response syndrome (SIRS) in          comparison to healthy volunteers.        -  The adhesion molecule Ninj1 is induced following nerve injury where it contributes to          nerve generation. Besides it is described to facilitate leukocyte migration especially          in the nervous system.        -  The investigators hypothesize that Ninj1 expression is increased in SIRS patients, which          will fortify its impact during inflammation and the transferability from bench to          bedside.   "
92174|NCT02079584|"     The objectives of this registry are to measure the outcomes, cost, adherence pattern and     experience of patients treated as outpatients with rivaroxaban after being diagnosed with     blood clots in the emergency department. The investigators hypothesize that patients will     have a relatively low rate of adverse events and higher adherence than has been reported     historically for warfarin treatment. Patients will be scheduled for follow up care with one     of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital or Eskenazi Health     Services after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis     (DVT). The investigators will collect information for a registry and a database will be     developed and blood specimens will be obtained at each follow up visit for analysis and     storage for possible use related to this treatment and research or study at a later date.     Questionnaires will be administered to collect variables that the investigators hypothesize     to be important to understand the causes of non-adherence. To better quantify the economic     impact, the investigators will also perform a cost effectiveness analysis with no comparator,     meaning the investigators will tabulate the cost of care for each patient enrolled using     variable costs from a UB92 report for each patient.   "
92189|NCT02079389|"     The following project deals with a Danish multicenter trial that evaluates the value of     Laparoscopic Ultrasound examination (LUS) in laparoscopic surgery for colon and rectum cancer     (CRC).      The project The value of laparoscopic ultrasound in patients undergoing laparoscopic     resection for colon and rectum cancer. - A prospective randomized trial is part of a ph.d-     study at the University of Southern Denmark in collaboration with several surgical     departments at hospitals in Southern Denmark.      The primary purpose is to investigate whether the use of laparoscopic ultrasound examination     (LUS) will change the stage of the tumor, lymph node and metastasis (TNM stage) and the     surgical approach in patients undergoing laparoscopic surgery for colorectal cancer (CRC).      As a secondary objective; an evaluation of the use of LUS will change the treatment strategy     for the individual patient with CRC.      As an other objective we wants to investigate whether the use of contrast enhanced ultrasound     examination in connection with LUS procedure increases the number of detected liver     metastases.   "
92175|NCT02079571|"     In traditional Chinese medicine (TCM), hot- and cold-attribute of food ingredients are a     major part of dietary therapy. Eight Principles including cold/hot, repletion/vacuity,     yin/yang and exterior/interior are used for diagnose by Chinese medical doctors. From the     perspective of TCM, all constitutions, diseases, herbal medicine and foods can be divided     into these two major categories, i.e., cold and hot. Therefore, dietary therapy claims that     the attributes of foods should be used to oppose our constitutions in order to harmonize     organ functions and maintain human vitality. The true benefit of dietary therapy is     considered to be the reestablishment of a harmonious balance between cold and hot, or     repletion and vacuity, within the human body.      Previous studies reported that the capillary red blood cell (RBC) velocity in nail fold     microcirculation (NFM) of the subjects with hot constitution accelerated significantly after     taking the hot attribute aged ginger tea, which might be the result of elevated vagal     activity leading to arteriole dilation in these subjects. In contrast, in subjects with cold     constitution, capillary RBC velocity decelerated significantly and skin temperature decreased     markedly after taking the cold-attribute coconut water, which might have been induced by     sympathetic nerve activation causing the arteriole to be constricted. As a result, the use of     capillary RBC velocity of NFM measured by laser Doppler anemometer may be a promising way to     classify attributes of food ingredients commonly used in Chinese medicine dietary therapy in     accordance with different personal constitutions.      Accordingly, it will be a worthwhile task to establish a modern scientific methodology to     define the attributes of food ingredients. The aim of this project is to investigate the     relationship between food attributes and the physiological signals produced in healthy young     subjects with different constitutions. In the first year of this project, investigators are     starting to determine the pulse waves produced in healthy subjects with different     constitutions by a Smart Pulse Wave Health Evaluation System (S-PULSE). Then, investigators     will investigate the relationship between food attributes, channel entries and the     physiological signals. Hopefully, the results will have a leverage on the powerful     integration capacity within National Taiwan University (NTU) campus to build a hub for global     TCM cloud.   "
92176|NCT02079558|"     Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of     maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH     would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin     was compared in prevention of postpartum hemorrhage after cesarean sections.   "
92177|NCT02079545|"     The purpose of the study is to assess the bioavailability (the extent to which a medication     becomes available to the body) of subcutaneously (under the skin using a needle) administered     sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using     a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the     SmartJect™ Autoinjector (PFS-AI) in healthy male participants.   "
92178|NCT02079532|"     This study will evaluate the efficacy and safety of MabThera in patients with active     rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha     inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous     inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated     with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate     therapy. The anticipated time on study treatment is 2+ years, and the target sample size is     100-500 individuals.   "
92179|NCT02079519|"     This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously     every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines     of prior therapy.   "
92180|NCT02079506|"     The objective of this study is to compare pharmacokinetics after single oral administration     of candesartan and rosuvastatin each separately versus coadministration of candesartan and     rosuvastatin in healthy male volunteers.   "
92184|NCT02079454|"     Research aimed to find a correlation with an invos drop and cardiac events in the     peri-operative period of non cardiac surgery.      The investigators postulate that a drop in the Invos numbers (with or without significant     drop in BP) is associated with a variable degree of cardiac suffering.      The idea is to prevent per and foremostpost-operative myocardial necrosis complications by     acting as soon as we have an INVOS drop during anesthesia.      The cardiac events will be monitored and defined according to the EHA (european heart     association) guidelines.      (Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored     per and post operatively.   "
92185|NCT02079441|"     1. To evaluate the immune response to vaccines in infants of IBD patients treated with          anti-TNF medications during pregnancy compared to infants of IBD mother not treated with          anti-TNF medications.        2. To evaluate the immune function of B and T cells at 3 months and one year of age in          infants of IBD patients treated with anti-TNF medications during pregnancy compared to          infants of non anti-TNF treated mothers.      The secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated     with anti-TNF medications during pregnancy and to evaluate the risk of infections during the     first year of life in this population, compared to children of IBD patients not treated with     anti-TNF medications during pregnancy.      Significance -The results of this study have the potential to change clinical practice of     anti TNF treatment during pregnancy and the follow-up of infants born to these patients   "
92186|NCT02079428|"     The purpose of CN-HF is to establish the national registration of hospitalized heart failure     patients, evaluate and compare the clinical features and prognosis of diastolic and systolic     heart failure, and find out the status of treatment and implementation of guidelines on heart     failure in China.   "
92187|NCT02079415|"     Saudi Arabia has been named by the International Diabetes Federation as among the top ten     countries with highest prevalence of diabetes. Women are said to have overall prevalence     twice that for men. With high birth rate in the country we decided to look at the impact of     diabetic pregnancies on their off-springs   "
92188|NCT02079402|"     The purpose of this trial is to o assess feasibility of a protocol comparing conservative     (trigger guided) vs. liberal (target guided) approach to fluid resuscitation in patients with     septic shock after initial fluid resuscitation.   "
92190|NCT02079376|"     Study to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the     improvement of glycemic control measured by changes in HbA1c.      Relationship between blood TG level and the GCM efficacy will be evaluated.   "
92192|NCT02079350|"     Although the negative impacts of colloid solutions with high molecular weight on renal     functions, combination of lower molecular weight colloid varieties with crystalloid solutions     and its use during intraoperative period have been subject to current research. Since the     first liver transplantation, pre-or post-transplantation renal problems are still among the     main causes of mortality and morbidity. The aim of the study was to evaluate the effects of     fluid replacement solutions used intraoperatively on renal functions in elective living-donor     liver transplantation.This study was approved by the Ethics Committee of Hospital and all     patients were informed and gave written consent. Participants were patients scheduled for     elective living-donor liver transplantation. Patients with normal renal function were     randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group).     Blood samples were obtained before induction of anesthesia (baseline), at the end of the     operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD,     CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.   "
92193|NCT02079337|"     Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled     for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical     studies investigating this question often use a numerical or verbal rating scale for     subjective evaluation of the surgical workspace. However, no good subjective rating scale     have been developed or validated. Neither have possible inter-individual differences in use     of such subjective scales been described.      Purpose:      The aim of this study is to validate different subjective rating scales to determine which     scale is most useful among surgeons.   "
92194|NCT02079324|"     The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after     intratumoral injection in head and neck cancer patience.   "
92195|NCT02079311|"     This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm     active self-warming blanket differs compared to active warming with forced air warming in     terms of core body temperature perioperatively.      A non-inferiority, prospective, open-labelled, randomized, parallel investigation.      Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air     warming. All subjects may receive rescue warming if their core temperature falls below     35.5°C. Rescue warming is optional and defined as the institution's standard of care to     prevent hypothermia.      The primary purpose is to investigate if there is a clinically relevant difference in core     body temperature between the two treatment groups.      A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each     treatment group. The number includes a 30% drop-out rate.   "
92196|NCT02079298|"     This study will investigate pharmacological interventions between fluconazole and ibuprofen     when they are given to premature newborn babys. This in order to find out if the drugs are     influencing each other when they are given at the same time. The study is meant to find out     if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.   "
92207|NCT02079155|"     This randomized clinical trial compares a recently developed technique, called robotic     laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of     robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in     treating patients with newly diagnosed, locally confined prostate cancer. Both procedures are     types of robotic radical prostatectomy, or the robot-assisted removal of the prostate though     a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions are     made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS     technique, all instruments are inserted through a single incision. R-LESS RP is less invasive     than RALP and may leave a smaller scar and cause less pain.   "
92208|NCT02079142|"     The purpose of this study is to evaluate two training methods of IPT with mental health     service providers in college counseling centers.   "
92197|NCT02079285|"     <Background/aims> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle     aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been     demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies     across EUS programs in Unites States, Europe and other areas of world. The investigators have     a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in     which the adequacy of specimens will be assessed by a single endosonographer.      <Methods> All EUS-FNAB procedures will be performed by an experienced endosonographer and the     adequacy of specimens obtained during EUS-FNAB will be also assessed by a same     endosonographer. A specimen will be considered adequate if there is an adequate number of     representative cells from the lesion. Samples considered to be adequate will be then     interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive     change, or negative for malignancy. Performance characteristics of EUS-FNAB including     sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with     the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up     of more than 6 months with repeat imagings.   "
92198|NCT02079272|"     The purpose of this study is to determine whether a new technique of radiotherapy for breast     cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first     two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac     imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions     and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early     stage.   "
92199|NCT02079259|"     The number of patients with acute congestion on chronic heart failure is increasing.     Ultrafiltration has recently been proposed as an alternative approach for the stabilization     of volume balance, especially in patients with imminent diuretic resistance.      There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser     effects on blood pressure and activation of renin angiotensin system, respectively . However,     recent studies revealed conflicting results: demonstration the superiority of ultrafiltration     in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess     of adverse events with ultrafiltration.      Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer     than aquaphesis with a constant ultrafiltration with comparable effectiveness   "
92200|NCT02079246|"     To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive     therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).   "
92201|NCT02079233|"     This is a study to determine the effect of four different dosing regimens of CLP in normal     healthy volunteers.   "
92237|NCT02078765|"     A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of     fall in BP during night time) is a strong predictor for the risk of cardiovascular disease     and mortality in patients with hypertension. Three factors seem to affect the night time BP:     chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure     is monitored.      Hypothesis:      Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than     conventional peripheral monitoring.      In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time     blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.      In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in     hormonal balance.   "
92202|NCT02079220|"     This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety,     and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line     treatment of subjects with mCRC.      Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in     this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice     between arm A and arm B will depend on the investigator's preference.      Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods        -  Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each          cycle, repeating every 14 days.        -  Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14          days.        -  Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every          14 days.      Arm B (every 3 week schedule):      Dosage and dosage regimen for all study periods        -  Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each          cycle, repeating every 21 days.        -  Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every          21 days.        -  Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every          21 days.   "
92203|NCT02079207|"     This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate     Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should     be naïve of Pneumococcal vaccine.   "
92204|NCT02079194|"     To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12     antagonist following 3-month of DAPT in patients undergoing PCI with DES.   "
92205|NCT02079181|"     This clinical trial studies the safety and drug distribution of the radioactive drug,     2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (fluorine F 18 d-FMAU     [18F-FMAU]), for imaging with positron emission tomography/computed tomography (PET/CT) in     patients with advanced cancers. A PET scan is a procedure in which a small amount of     radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed,     computerized pictures of areas inside the body where the glucose is taken up. Because cancer     cells often take up more glucose than normal cells, the pictures can be used to find cancer     cells in the body. PET/CT using the drug fluorine F 18 d-FMAU, may help find cancer and find     out how far the disease has spread.   "
92206|NCT02079168|"     To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation     following elective keloid excision.   "
92209|NCT02079129|"     The study objective is to assess the agreement between cMRI PVL grading (based on regurgitant     fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to     the circumference of the annulus).   "
92210|NCT02079116|"     This study aims to determine changes in cerebral blood flow of people with obesity after the     ingestion of fat.   "
92267|NCT02078375|"     This study will evaluate if the combination of resistance exercise and protein     supplementation will increase muscle strength and muscle mass among older individuals with     rheumatoid arthritis (RA).   "
92211|NCT02079103|"     Background: High intensity training of challenging tasks with many repetitions is a key     factor for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation     systems provide the potential to increase intensity and offer challenging and motivating     tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered     studies.      Methods: In 5 participating rehabilitation centers patients in the subacute phase after     stroke will be randomized to either a group receiving 4 weeks of VR training in addition to     conventional arm training or a group receiving dose-matched and therapist attention-matched     conventional arm-training.      Hypothesis: VR training is more effective in improving arm motor function than conventional     arm training in the subacute phase after stroke.   "
92212|NCT02079090|"     Sedation and pain medication is required when bone fractures need to be fixed in the     emergency department (ED). Many drugs have been used safely as single agents or in     combination for the sedation of children. These drugs include Propofol, Ketamine and     Fentanyl. However each of these medications has side effects and drawbacks. The combination     of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of     Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study     is to determine which combination works better. The primary outcome of this study is to     determine which drug combination has a shorter time from onset of sedation to full recovery.     The investigators hypothesize that Fentofol will have shorter sedation to recovery times.   "
92213|NCT02079077|"     In this project, the investigators want to analyse the capacity of Acetylsalicylic acid and     hydoxychlroquin (HCQ) to induce an Immune Quiescence (IQ) phenotype, which has been     previously associated with natural protection to HIV infection. This phenotype is     characterized by lower expression of genes involved in cellular activation, lower resting     levels of inflammatory cytokine production, lower level of systemic activated T cells,     increased levels of systemic T regulatory, increased production of anti-viral anti-protease     serpins at the female genital tract and reduced numbers of HIV target cells (mainly CD4+     CCR5+ T cells) in the FGT ( female genital tract).      The objective of this study is to determine if daily oral administration of Acetylsalicylic     acid or hydroxychlroroquin can reduce systemic and mucosal immune activation in HIV negative     women.   "
92214|NCT02079064|"     The aim of this prospective randomized study is to evaluate the perioperative effects of     inhalational anesthesia (desflurane) and intravenous anesthesia (propofol) on hemostasis in     patients undergoing splenectomy with liver cirrhosis guided by the new technology (ROTEM) and     the traditional laboratory hemostatic markers.   "
92217|NCT02079025|"     This trial uses a ultra high-resolution ultrasound system and specialized transducer,     intended for use in prostate imaging. The system's image resolution is significantly better     than the standard of care, due to its higher frequency. This allows the system to visualize     suspicious areas and structures, and for greater accuracy for guided biopsy.      The primary objective of this study is to demonstrate that ultra high-resolution transrectal     ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound     (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer     and with an indication for prostate biopsy.      The secondary objective of this study is to compare the difference in the rate of detection     of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator     training to after investigator training.      The tertiary objective for the investigation is to compare the combined sensitivity and     specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs.     LR-TRUS.   "
92218|NCT02079012|"     The purpose of this study is to investigate the short- and long-term effects of a 10-week     walking program, based on the self-determination theory, in people with mental disorders. The     investigators expect positive effects on:        -  Physical fitness        -  Physical activity        -  Well-being (less feelings of anxiety, less feelings of depression) The investigators          also expect underlying psychosocial processes to influence these effects.   "
92219|NCT02078999|"     To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and     for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load,     procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American     College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus     conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified Clinical     Pulmonary Infection Score (CPIS) through the mechanical ventilation period   "
92220|NCT02078986|"     The main aim of the study is to determine the effects of Whole-Body Electromyostimulation     (WB-EMS) on body composition and muscle strength compared with the golden standard High     Intensity Resistance Exercise Training (HIT) in healthy sedentary middle aged males.   "
92221|NCT02078973|"     Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and     sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which     stimulates V1-receptors in the vascular bed and may change both central and brachial     hemodynamics and plasma concentration of vasoactive hormones.      The purpose of the study is to measure the effects of tolvaptan on renal handling of water     and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide     (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).   "
92222|NCT02078960|"     To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase     1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary     safety and efficacy of omacetaxine following a fixed-dose administration to patients with CP     or AP CML who have failed 2 or more tyrosine kinase inhibitor (TKI) therapies.   "
92223|NCT02078947|"     Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise     intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also     termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and     additionally diastolic function (assessed echocardiographically). The investigators     hypothesize that exercise training reverses HFpEF and that intensity of exercise training is     more important than duration.   "
92224|NCT02078934|"     Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost     400,000 ventral hernia repairs annually in the United States. There is an even higher     incidence of incisional hernia recurrence after prior repair if the patient is obese. Each     subsequent hernia repair leads to increased morbidity and durability. It is not infrequent     that many surgeons will advise overweight or obese patients to lose substantial weight prior     to complex incisional hernia repair.      However, it is quite difficult for any individual to lose more than 8 pounds a month in a     safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet     and exercise alone. Many patients with incisional hernia are physically debilitated that they     cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic     bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a     technically challenging endeavor since prior abdominal surgeries increase the amount of     intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not     candidates for laparoscopic weight loss surgery because of inability to tolerate     pneumoperitoneum due to underlying physiologic dysfunction.      - Novel minimally invasive endoscopic technique may help obese patients with an incisional     hernia lose weight in a safe and rapid fashion. Early case reports and small case series on     gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious     weight loss. There have been reports of achieving nearly 20-25% excess weight loss.      Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a     primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8     Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for     weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System     (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight     loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of     not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric     greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11      The intent of this study is not to demonstrate endoscopic suturing to be a primary option for     weight-loss surgery. Preliminary reports have shown such procedure is technically feasible     but not durable and the effects of the procedure varied widely among the study     participants.12 The investigators view this technology as a bridge for morbidly obese     patients, who will need subsequent surgery for another surgical disease, to improve their     body habitus and decrease their postoperative morbidity and mortality. The aims of the     investigators study are:        -  Feasibility of endoscopic gastric sleeve plication        -  Define the technical aspects of endoscopic suturing for sleeve plication        -  Provide long-term follow-up for both weight loss and resolution of their co-morbidities        -  Time from the endoscopic procedure to their incisional hernia repair        -  Photographic evidence of the stomach after endoscopic plication during the incisional          hernia repair      There are several advantages for the proposed study. First it avoids entering the     intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the     need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly,     it avoids placing endoscopic intra-luminal devices such as intragastric balloons or     duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device     withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices     will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13,     14      The implications of this study can be far-reaching. Once efficacy is demonstrated where     enough weight loss is achieved that patients can safely and quickly undergo their incisional     hernia surgery, the investigators can then conduct a retrospective case-control cross-matched     study to further delineate its true benefit. If there is a true benefit, then a randomized     control study can be employed in the future.   "
92268|NCT02078362|"     Peripheral blood will be taken from the enrolled patients at National University Hospital and     from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine     candidates.   "
92225|NCT02078921|"     Previous studies have shown that interventions which modestly increase blood nitrite_ improve     skeletal muscle function on exercise while sparing oxygen, and have been also shown to open     up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the diet is     absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to nitrite,     which is then absorbed into the bloodstream. .      The purpose of this study is to look at the effects of oral inorganic nitrate supplementation     on clinical markers of heart ischaemia and the frequency of angina.   "
92226|NCT02078908|"     The purpose of this study is to investigate the effect of different doses of sodium nitrite     infusion in 12 healthy subjects. The effects on renal handling of nitrite, nitrate, sodium     and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central     blood pressure will be evaluated.      Hypothesis      Sodium nitrite infusion        1. increases urinary sodium excretion and renal filtration rate        2. lowers blood pressure, central as well as peripheral        3. affects vasoactive hormones        4. it is possible to establish a dose that affects the renal function with only minor          effect on the blood pressure.   "
92227|NCT02078895|"     Botulinum toxin type A (Botox A) has shown great success in treating certain urologic     conditions. A recent study has documented that Botox injected around the ureteral orifice (or     place where the tube that connects the kidney to the bladder enters the bladder), during     placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the     kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced     by patients. This finding was quite remarkable as stents are commonly used in many Urologic     conditions, and these stents produce a remarkable degree of patient discomfort. Despite the     great improvement in pain reduction, the irritative voiding symptoms [frequent need to void,     urgency, burning with urination (dysuria) or nighttime voiding (nocturia)] were not     ameliorated by the Botox injections in the ureteral orifice. However, it has already been     well documented that in other clinical settings, administrations of Botox into the bladder     muscle, has been shown to reduce these irritative symptoms.      The objective of the study is to determine if pain and irritative lower urinary tract     symptoms related to ureteral stent placement will improve after the injection of Botox around     the ureteral orifice and in the bladder itself.   "
92228|NCT02078882|"     The purpose of this study is to determine if abatacept (Orencia) is effective in patients     with primary biliary cirrhosis who do not respond adequately to standard treatment with     ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).   "
92238|NCT02078752|"     To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients     with advanced solid tumors in order to determine the maximum tolerated dose and select the     recommended Phase 2 dose.   "
92229|NCT02078869|"     When patients undergo in vitro fertilization (IVF), they often make more embryos than it is     safe to transfer back in the womb all at once. These excess embryos are frozen and stored for     future use. Frozen embryo transfer (FET) is therefore an important option of IVF where there     are extra embryos. FET should take place under ideal conditions when uterine receptivity and     uterine endometrial lining thickness are at the appropriate developmental stage as the     embryo. A common way of preparing the uterus for FET is by using medications (Estrogen and     Progesterone) that imitate a normal menstrual cycle while monitoring the endometrial lining     development by transvaginal ultrasound. Progesterone (P4) may be administered vaginally or     intra-muscularly (IM). The mode of Progesterone administration is based upon local     conventions, experts' opinion and patients' preferences. All the mentioned modalities are     common in the daily practice of IVF clinics across the world.      The current medical literature does not present high quality evidence for the superiority of     one form of Progesterone administration over the other for FET. The investigators know that     in fresh embryo transfer cycles where natural follicles continue to function and produce     Progesterone as corpora lutea, there were no reported differences in pregnancy rates when     luteal vaginal P4 was compared with IM P4 support, but the investigators do not have the same     reassurance regarding frozen embryo transfers. The aim of this study is to compare vaginal     versus IM route of administration of P4 for FET cycle in a well-designed trial. Since many     outcome variables are possible, the investigators have chosen to concentrate in the one that     might shed light on a possible biological difference between the two modes of Progesterone     administration; uterine contractions. Uterine contractions have been previously recognized as     a possible factor that compromises success rates in patients undergoing IVF treatments.     Progesterone is considered a uterine relaxant and its levels in the blood versus the levels     in the uterus differ by its mode of administration: blood levels are higher when given IM     whereas uterine P4 concentrations are higher when given vaginally. The investigators are     interested to see whether IM progesterone in frozen embryo transfers presents a different     uterine contraction pattern than the vaginal administration.   "
92230|NCT02078856|"     The purpose of this trial is to determine the efficacy and safety of A3384 administered to     patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).   "
92231|NCT02078843|"     The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher     diagnostic value in the detection of neuroendocrine tumors than the established imaging     method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging     procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the     investigators will compare the diagnostic performance of both methods.   "
92232|NCT02078830|"     The objective of this study is to assess the efficacy of 3M™ Tegaderm™ CHG I.V. Securement     Dressing at the entry-site of a EVD in reducing quantity of microorganisms (CFU/cm2) after a     time period of 5 days as a surrogate marker for EVD-associated infections [1, 2], compared to     a nonantimicrobial polyurethane 3M Tegaderm™ Transparent Film Dressing. We aim to     investigate, if the adjunct of an additional CHG-impregnated device on a routinely basis for     the daily care is as a valuable and effective option to reduce contamination of the EVD     entry-site and consecutive colonization of the catheter.   "
92233|NCT02078817|"     This study will test the use of ketamine for treatment of depression in adolescents that have     not responded to other treatments. We will also examine neurobiological mechanisms of     treatment.   "
92243|NCT02078687|"     This is a follow-up cohort study of 6 years old children born preterm in Denmark from     2004-2008, and at four different neonatal units. During hospitalisation they received breast     milk with fortification. At time of discharge there were made 3 different nutrition groups;     if possible they were randomised into one of two groups:        1. Breastfeeding solely        2. Breastfeeding with fortification           If breastfeeding was not possible they were put in group 3 and were bottle fed with:        3. Preterm formula      This nutrition intervention went on for 4 month. At the age of 6, the children will be     invited to come for an ambulant control and other examinations regarding growth, allergy and     metabolic syndrome.   "
92289|NCT02078089|"     This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with     morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the     safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary     endpoints are improving pain control, reduce morphine use and improve the quality of life.   "
92234|NCT02078804|"     Colorectal cancer (CRC) is a major cause of death in Sweden. There are approximately 6000 new     cases each year in Sweden and the disease specific mortality is more than 40%. There risk is     about 1% to develop CRC between 60-70 years of age making 60-year olds a suitable target     population for colorectal cancer screening.      The Swedish ministry of health and social affairs proposed a national study on the efficiency     of colorectal cancer screening in the Swedish population regarding mortality, but also what     screening method to be used. Eighteen participating counties of Sweden now fund the study to     be launched in 2014.      From the Register of the total population individuals 59-62 years of age will be randomized     and invited by mail to screening. Twenty- thousand individuals will be invited to primary     colonoscopy and 60 000 individuals will be invited to high sensitive FIT (approximately 10%     positive) and if positive to a subsequent follow-up colonoscopy. If test negative a second     round of FIT will be asked for in two years. In total 120 000 randomized individuals will not     be invited to screening, but followed in the Swedish Cancer register and serve as controls.     The inclusion period I set to three years (five years with the second round of FIT)     generating approximately 5 000 colonoscopies yearly the first three years and 1200 year four     and five at a compliance rate of 50% in the colonoscopy arm and 60% in the FIT arm.      Follow-up time is set to 15 years with the primary endpoint disease specific mortality, but     also incidence. Secondary outcomes by others to be studied are in short quality assurance     variables of colonoscopy, participants and non-participants experiences of the invitation and     the screening procedure, health economy measures of the CRC-screening study and when     implemented in clinical care.   "
92235|NCT02078791|"     The patients who were not pain control, are referred to the Chronic Pain Unit so its     complexity is greater. Made two different interventions in three groups of people with     fibromyalgia. In the first group will proceed to infiltrate the painful area with medication,     in the second GPST (Group Problem Solving Technique) and the third group both techniques.     GPST will want to identify problems that people associate with fibromyalgia, as well as     proposed solutions and it they have been carried out successfully or not. Will be essential     to identifying and solving problems and using techniques to increase assertiveness,     self-esteem and eliminating negative thoughts. Observing if after performing any of these     techniques (infiltration, GPST or both) there is a better quality of life, reduce thoughts of     suicide, pain and improves sleep quality. We also analyzed the satisfaction or not with     therapies received and perceived usefulness.   "
92236|NCT02078778|"     The purpose of this study is to examine the effect on blood pressure of 3 months of treatment     with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea     (OSA).      Hypothesis:        1. Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure          more accurately than peripheral 24-h BP monitoring, because the measurement is painless          and does not interfere with the patient / subject's activities during the daytime or          nighttime sleep.        2. Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.      3. The renal treatment of salt and water is abnormal in OSA, improved during treatment with     CPAP.      4. Quality of life improves during treatment with CPAP   "
92292|NCT02078050|"     Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and     volitional measures of inspiratory muscles strength include the nasal pressure with an     occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately,     volitional maneuvers depend of patient effort. The aim of this research is to validate a     non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular     diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic     nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3 inspiratory     pression levels (0, -1 cm H2O and -5 cm H2O).   "
92239|NCT02078739|"     The combined diagnosis of chronic obstructive pulmonary disease (COPD) and heart failure (HF)     is common but often missed because of similarities in clinical presentation, risk factors,     and patient characteristics. The concurrent presence of both diseases worsens the limitations     in exercise capacity and quality of life that patients experience with either disease alone.     This pilot study will test the feasibility of a yoga program conducted in patients' homes     using multi-point interactive videoconferencing (Tele- Yoga) for patients with combined     COPD/HF diagnoses. The investigators hypothesize that patients who receive a yoga program at     home, compared to an educational control group, will experience fewer physical symptoms and     better quality of life.   "
92240|NCT02078726|"     The investigators believe that glucagon therapy will have a positive impact on key parameters     of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma     detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort,     and patient's willingness to undergo a repeat colonoscopy.   "
92241|NCT02078713|"     The investigators have designed a tablet-based decision support tool to help women learn more     about their birth control options and support them in choosing a method they are happy with.     The investigators will test whether the decision support tool helps women choose a birth     control method they can continue using successfully by having some women use the tool before     their birth control-related visit to a health care provider, and some women not use the tool     before their visit. The investigators will then follow up with all the women at four months     and seven months after their visit to see if they are still using the birth control method     they chose at the visit and how happy they are with the method.      Hypotheses:        1. Women who use the contraceptive decision support tool will be more likely to continue          using their chosen method at 4 and 7 months follow-up, compared to women who receive          usual care.        2. The contraceptive decision support tool will increase women's knowledge, choice of, and          use of highly effective reversible contraception, compared to usual care.        3. The contraceptive decision support tool will decrease decision conflict, compared to          usual care.        4. The contraceptive decision support tool will increase patient satisfaction with the          clinic visit and with their method, compared to usual care.        5. Women who use the contraceptive decision support tool will have fewer unintended          pregnancies during the follow-up period, compared to women who received usual care.        6. The contraceptive decision support tool will increase shared patient-provider decision          making in contraceptive counseling visits, compared to usual care.        7. The contraceptive decision support tool will decrease provider frustration when          providing contraceptive counseling and increase provider job satisfaction.        8. Women using the tool will be more likely to report use of any moderately or highly          effective method of contraception at 4 and 7 months follow-up, compared to women not          using the tool.   "
92242|NCT02078700|"     The objective of this phase 2 study is to evaluate the feasibility of an early palliative     care intervention for metastatic cancer patients. Feasibility will be assessed in terms of     percentage of patients that accept the proposal of the early palliative care intervention and     that effectively start to be followed in the palliative care out-patient clinic. The study     will be performed in a consecutive series of newly diagnosed patients affected by lung cancer     (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV), stomach     (stage IIIb-IV).   "
92290|NCT02078076|"     Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis     detection and quantification (and of function assessment) during MRI without breath-holds in     a population of adults and children with Duchenne myopathy.   "
92244|NCT02078674|"     This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years     old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior     influenza immunization within the past three months. Subjects 18 to 49 years of age will     comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50     to 64 years.      Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0     and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately     385 days total, or approximately 13 months from the first dose.   "
92245|NCT02078661|"     To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension     compared to placebo when administered two times daily for 14 days in subjects diagnosed with     dry eye syndrome   "
92246|NCT02078648|"     The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment     for recurrent glioblastoma multiform (GBM).   "
92247|NCT02078635|"     Presently in Canada, 29% of deaths are due to cardiovascular disease (CVD), costing $20.9     billion annually. The investigators have, therefore, brought together an unique network of     investigators at different stages in their careers with a range of disciplines (nutrition,     cardiology, diabetes, imaging, physics, clinical trials, statistics, laboratory medicine,     primary care, genetics, psychology, knowledge translation (KT), and epidemiology) and with     international recognition , experience and connections, to undertake a multi-centre study     which will test the ability of the dietary Portfolio PLUS approach over 3 years to reduce the     progression of plaque build-up in the carotid artery as assessed by Magnetic Resonance     Imaging (MRI) in individuals with hypercholesterolemia.      The dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant     sterol and nuts) which has been proven in many of their studies to be an effective     cholesterol-lowering diet will be further enhanced by increased levels of monounsaturated     fats (MUFA) and low glycemic index foods. Will this enhanced dietary strategy (dietary     Portfolio PLUS ) reduce the progression of carotid atheromatous lesions, LDL-C and blood     pressure while reducing the number of hyperlipidemic individuals requiring statins?   "
92248|NCT02078622|"     Evaluate subjects in an prospective randomized controlled trial in which subjects will be     administered scientifically validated questionnaires to determine the effect of the education     and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and     quality of life as primary endpoints      Utilize: Chronic Respiratory Disease Questionnaire (CRQ)      The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency     room encounters, hospital admissions)   "
92249|NCT02078609|"     This study will assess the safety and preliminary efficacy of escalating doses of LGH447     monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.   "
92293|NCT02078037|"     Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either     the experimental group which will keep them at a normal body temperature or the standard of     care group. The investigators propose to test the hypothesis that prophylactic forced     normothermia in patients with ICH leads to less systemic inflammation and decreased     perihematomal edema.   "
93379|NCT02063815|"     The purpose of this randomized clinical trial was to compare caries prevention of a     conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and     fissures over a one year period in a high caries children group. Additionally the     concentration of Fluoride in saliva was evaluated.   "
92250|NCT02078596|"     Though the Disruptive Disorders of Childhood and Adolescence are a major source of morbidity     and fill a large proportion of special education slots, specific pharmacologic treatment is     available only for those children with Attention Deficit/Hyperactivity Disorder. Other     disruptive children are usually said to have Oppositional Defiant or Conduct Disorder.     These diagnoses are useful descriptively but they do not have specific treatment implications     In the course of treating adolescents with explosive tempers and severe mood swings with     Depakote (divalproex sodium), the investigators learned that younger children manifest     symptoms that seemed identical to those constituting the adolescent disorder. They were in     special education programs and not responding to psychostimulants.      The investigators systematically collected data on these children using the same screening     criteria as in our studies of adolescents. Since Depakote has been used to treat seizures in     children for more than twenty years, a great deal was known about its safety profile in the     pediatric population. The investigators treated 7 children, age 7-12, whose recurrent temper     outbursts and chronic mood lability did not respond to individual/family therapy. After     parents signed informed consent and children gave assent, these subjects would receive open     label Depakote in doses sufficient to reach a blood level between 50-100 micrograms/ml for     six weeks. The family received supportive therapy.   "
92251|NCT02078583|"     Benzodiazepines is a commonly uesd sedative medication,there are many reports that     Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines     requirements .The purpose of this study is to determine whether analgesia based sedation     protocol reduces the incident of delirium.   "
92252|NCT02078570|"     The major purpose of this study is to evaluate a laboratory developed test that measures     multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood     samples. The biomarker and antibody results along with your personal medical profile will be     evaluated to determine your risk for the presence of a malignancy in the breast as compared     to your breast evaluation assessment conducted by your physician.   "
92253|NCT02078557|"     This study will assess multiple doses of MK-8892 administered to participants with pulmonary     hypertension out of proportion (PHOOP) and heart failure with reduced left ventricular     ejection fraction (rEF). It is hypothesized that generally safe and well tolerated multiple     doses of MK-8892 will achieve a true reduction from baseline in pulmonary vascular resistance     (PVR) greater than 12%.   "
92264|NCT02078414|"     Women using an emergency contraceptive method must use back up protection for 1-2 weeks     depending on method. The Copper-IUD is the most effective emergency contraceptive method. The     investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use     of an effective contraceptive method 3 months and 6 months after the use of an emergency     contraceptive method than women who choose to use the emergency contraceptive pill EllaOne     (ulipristal acetate).   "
92254|NCT02078544|"     The purpose of the study is to identify biomarkers and potentially actionable mutations/     activated molecular pathways and evaluate the impact of molecular profiling information on     patients with gynaecological cancer.      The hypothesis of the study are:        -  Analysis of gynaecological tumour samples will allow us to identify novel and/or          actionable molecular changes that may drive therapeutic strategies for the management of          these cancers.        -  Molecular profiling will improve the outcome of novel targeted-agent treatment in          clinical trials        -  Molecular profiling of paired samples (primary/recurrent and primary/metastatic) will          provide new insights into mechanisms underlying drug resistance and metastasis in          gynaecological cancers.   "
92255|NCT02078531|"     The purpose of the study is to examine cognitive and brain function in stage I-III breast     cancer patients who have undergone adjuvant systemic therapy (chemotherapy or chemotherapy     plus anti-hormonal therapy) in comparison to a group of healthy controls.      Our hypothesis is that systemic adjuvant therapy in the form of chemotherapy or chemotherapy     and anti-hormonal therapy given to primary breast cancer patients can cause cognitive     impairment. We hypothesize that the use of simultaneous PET/MRI will allow us to determine     key regions in the brain that show metabolic, structural, and functional deficits in a     semi-quantitative manner and reveal subtle changes that are often missed during     neuropsychological tests due to the low sensitivity of neuropsychological batteries.   "
92256|NCT02078518|"     The purpose of this study is to gives understanding to level of physical activity, occurrence     of fatigue and quality of life amongst multiple myeloma survivors in the local setting. As     multiple myeloma survival improves, it is vital to focus on interventions that will help to     maximize QOL. A positive correlation may suggest that exercise is such an intervention.      The hypothesis are multiple myeloma survivors are performing low levels of physical activity.     Higher levels of physical activity will be associated with higher levels of QOL and lower     fatigue levels.   "
92257|NCT02078505|"     The polycystic ovary syndrome is intimately associated with body weight and nutrition.The     genomic era did not bring a breakthrough to the understanding of the syndrome. The recent     surge of studies on gut microbiome has raised the possibility that the specific diet, which     often affect these women favorably, would change their gut microbiome. Hence, the     investigators will examine their gut microbial population in comparison to normal ovulatory     women and then examine whether a low carbohydrate diet causes favorable change in their gut     microbial population.   "
92258|NCT02078492|"     Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in     treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.   "
92259|NCT02078479|"     The purpose of this study isto assess the efficacy of daily 10 sessions of rTMS over primary     motor cortex in patients suffering from malignant neuropathic pain. Thirty four patients were     divided randomly into 2 groups equally using closed envelops to undergo real (20 Hz, 10     second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80%     of motor threshold over hand area of motor cortex) or sham rTMS (same parameters but with     coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).     Patients were evaluated using a verbal descriptor scale (VDS), visual analog scale (VAS),     Leeds assessment of neuropathic symptoms and signs (LANSS) and Hamilton rating scale for     depression (HAM-D) at baseline, after 1st, 5th, 10thtreatment session, and then 15 days and 1     month after the end of treatment. ic pain.   "
92260|NCT02078466|"     The aim of this study is to examine the effect of an intervention that consist of assessment     of functional ability, rehabilitation plan and follow-up at home for older medical patients.      The hypothesis is that assessment of functional ability, development of rehabilitation plan     and follow-up at home reduce the older medical patient's risk of readmission. Also the     intervention is expected to reduce mortality, number of contacts to general practitioners and     emergency physician   "
92261|NCT02078453|"     Radiographs have been used to aid dentists in detecting the presence of cavities in the     deciduous teeth of children. This procedure is globally recommended because the conventional     clinical examination usually overlooks some cavities. However, the real benefit of performing     dental radiographs for this purpose is still unclear. Besides the hazards of ionizing     radiation, the radiographs could provoke overtreatment of the children; hence, dentists would     tend to restore more teeth than would be really necessary. Nowadays, it is preferable to     overlook some cavities than treat the teeth unnecessarily. Therefore, the investigators aimed     to perform this study to compare two different strategies for detecting cavities in deciduous     teeth of children: one based on clinical examination performed alone and other using     radiographs adjunct to the clinical examination. To compare these strategies, the     investigators will consider outcomes related to children's health and welfare.   "
92262|NCT02078440|"     The objective of this study is to evaluate the relative bioavailability, and the rate and     extent of absorption of bromocriptine in male and female children and adolescent Type 2     Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions.      It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes     children aged 10- to less than 18 years differs appreciably from that in healthy adults.     Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children     have demonstrated little difference in clearance among children over 10 years of age compared     to adults (Blanco et al, 2000). However, differences in blood volumes or other factors may     impart differences that could affect the pharmacokinetic properties of bromocriptine-QR.     Therefore, this study will assess the pharmacokinetics in children aged 10-to less than 18     years who have type 2 diabetes. After describing the profile of bromocriptine-quick release     in this patient population, a follow on study will be conducted to evaluate its safety and     efficacy in treating children and adolescents who have type 2 diabetes.      The pharmacokinetic profile of bromocriptine will be determined following the administration     of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study     will be a single period, bioavailability study in 30 patients. The study duration will be 3     days.   "
92263|NCT02078427|"     The purpose of the study is to document the natural history of hemophilia. A disease and     long-term outcomes in terms of effectiveness, safety and quality of life (QoL) in     participants receiving ADVATE in routine clinical practice. Participants may use any     treatment regimen, including on-demand and prophylaxis using standardized regimens or     individual pharmacokinetic (PK)-guided dosing regimens, or immune tolerance induction (ITI)     therapy, as determined by the treating physician.   "
92269|NCT02078349|"     This is an open-label, dose-escalation (Phase 1a) and expansion (Phase 1b) study to evaluate     the safety and tolerability of KPT-330 and determine the recommended phase 2 dose (RP2D) in     patients with solid tumor malignancies. The study drug KPT-330 or Selinexor works by blocking     high levels of exporter proteins in cancer cells so that the tumor suppressor proteins (TSP,     proteins that help to protect cells from becoming cancerous) and growth regulatory proteins     (GRP, proteins that help control the growth of cells) will remain in the nucleus in its     activated form. The idea for using this drug is that the blockage of this export of     proteins from the nucleus should result in stopping the growth of tumor cells. Based on its     mechanism of action, KPT-330 is a new class of drug called Selective Inhibitor of Nuclear     Export (SINE).      The purposes of this research study are to find out more information about the drug such as:     the highest dose of KPT-330 that can be given safely, the side effects it may cause, to     examine how the body affects the study drug concentrations in the blood (called     pharmacokinetics or PK), to examine the effects of this study drug on the body (called     pharmacodynamics or PD) and to gain some information on its usefulness in treating cancer.      Benefits of the study include the chance of disease control for patients with treatment     refractory cancer for which no other standard treatments are available. Common side effects     (35-73%) in humans have mostly been mild and reversible. These include nausea, loss of     appetite, fatigue, vomiting and weight loss.   "
92270|NCT02078336|"     The study aims to compare procedural sedation protocols, specifically applied for the     delivery of regular dental care in persons with a mental disability.      The primary objectives are:        -  To assess the level of cooperation during regular dental care using different procedural          sedation protocols        -  To assess patient safety during regular dental care using different sedation protocols        -  To assess patient comfort and possible side-effects after regular dental care using          different sedation protocols   "
92271|NCT02078323|"     The purpose of this study is to understand how a drug called Linaclotide improves bowel     function and abdominal pain in patients with Irritable Bowel Syndrome with Constipation     (IBS-C) as well as to examine whether Linaclotide alters communication between the brain and     pelvic-floor region.      Linaclotide has been shown to improve abdominal pain and bowel symptoms in IBS-C, and is     approved by the FDA for the treatment of this condition. However, how exactly this drug works     to relieve abdominal pain and discomfort in humans is not clearly known. Studies in animal     models suggest that patients with IBS-C have hypersensitivity in the gut.      Consequently, in IBS-C patients, there is rapid and excessive conduction of signals both from     the brain and central nervous system region towards the pelvic-floor (anorectal axis) and the     reverse direction. The investigators hypothesize that treatment with Linaclotide may     improve/normalize these signals and thereby improve bowel symptoms.      Investigators will test this theory using a new, noninvasive (and established) method of     studying this communication pathway between the brain and gut.   "
92272|NCT02078310|"     A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation     Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric     Volunteers and in Geriatric Patients with Dementia   "
92273|NCT02078297|"     The goal of this project is to study some mechanisms involved in the dysregulation of the     immune system observed in the skin of subjects with psoriasis. This will be done by analyzing     specific immune cells as well as gene and protein expression in small skin samples (biopsies)     from patients with psoriasis. These results will be compared to the skin of healthy subjects     without psoriasis.   "
92274|NCT02078284|"     This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide     (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO)     Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the     past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related     parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.   "
92275|NCT02078271|"     WHO has urged all developing countries to develop programmes to improve complementary-feeding     (CF) practices because of their importance for optimal growth, development and health of     infants and young children While supplementation programmes and/or highly-fortified     super-foods have limited success in improving CF-practices in disadvantaged environments,     population-specific food-based dietary guidelines (FBDG), based on locally-available foods     and requires minimal changes to local food pattern, will enhance the chances of programme     success.      Our previous study was able to identify the need for, potential and finally develop FBDG for     CF of 6-8mo and 9-11mo infants using combined linear-and-goal programming approach (LP     approach). This research is therefore being made to support the next phase of the study i.e.     to assess the efficacy of FBDG, for improving CF/dietary-practices and growth in <24mo     children (window of opportunity). As growth and development is inter-related, home-based     stimulation will be included in this trial to see the effect on child development. While     studies have shown that stimulation at early age benefits children through their late     adolescence; evidence from Indonesia is lacking. This study therefore aims to see the effect     on growth and development of community trial using food-based dietary guideline and     stimulation. It is expected that findings from this study will provide scientific evidence as     the basis for program formulation.   "
92276|NCT02078258|"     In this study, we test whether a two-week 8-session attention bias modification (ABM)     training could reduce depressive symptoms relative to placebo controls in adolescents with     major depressive disorder at posttraining and follow-ups.   "
92277|NCT02078245|"     Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a     positive impact in survival for patients with an increased genetic risk to develop pancreas     cancer.      In this study, following the indication of the swedish guidelines, consecutive patients with     a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance     Imaging (MRI) based. The results of this study were analyzed looking in the patients files     collected during the screening period.   "
92278|NCT02078232|"     The purpose of this study is to compare the diagnostic gain between 22G standard needle vs     19G Flex needles transduodenal punctures of masses of the pancreatic head.   "
92279|NCT02078219|"     This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients     with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg     once daily, respectively will result in greater reduction of sUA compared to placebo.   "
92280|NCT02078206|"     The purpose of this project is to assess the efficacy of an early neurocognitive intervention     for ICU patients, in terms of psychopathological, neuropsychological and functional     improvement. The treatment is supported in an interactive advanced computing platform that     includes the continuous biomedical registration of the patients and a virtual reality     software specifically designed for critical patients.      The investigators expect an improvement in neuropsychological, psychopathological and     functional status at hospital discharge and 3 months follow-up in those patients that have     received the early neurocognitive intervention comparing with patients treated as usual.     Furthermore the investigators expect a decrease of episodes and/or duration of delirium in     ICU patients.   "
92281|NCT02078193|"     The primary objective of this study is to demonstrate that administration of belatacept in     maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody     (DSA).   "
92294|NCT02078024|"     We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to     IVM alone given annually, which is the current standard for mass drug administration (MDA),     is more effective in sterilizing adult worms. We will also address whether IVM plus ALB given     twice per year is superior to IVM given once per year or twice per year.   "
92315|NCT02077751|"     Objective: To gather safety and efficacy BioRBC data from adult subjects who previously     developed transient BioRBC antibody responses by redosing them and observing for adverse     clinical or laboratory (i.e., a positive BioRBC antibody titer) outcomes to determine if RBC     kinetic study results differ from the previous study.      Hypothesis: BioRBC survival studies performed in adult subjects who previously developed a     transient BioRBC antibody response will: 1) be associated with no adverse clinical or     laboratory events; 2) experience a second transient, BioRBC antibody response; and 3) display     a pattern of RBC survival that is identical to their prior dosing with BioRBCs at the same     dose.   "
92282|NCT02078180|"     The objectives of this project are to determine if the bioavailability and release pattern of     bupropion HCl products differ and if the genotype of the metabolic enzymes affects the     saturation of intestinal enzymes with different dose strengths within one product line.     Findings from this project will help the FDA Center for Drug Evaluation and Research's (CDER)     Office of Generic Drugs improve policy development and review practice in the future for     similar products, e.g. extended release oral drug products being metabolized in the gut wall     and having multiple strengths.      Aim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy     individuals when they ingest different strengths of bupropion (75-300 mg) with variable     release profiles (IR vs XL vs SR) in GI tract.      Working hypothesis: Variation in release rate and mechanism of bupropion formulations in     gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract,     which will generate different concentration of bupropion and its metabolites in plasma.      Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and     pharmacokinetics of bupropion      Working hypothesis: The gain of function of CYP2B6 variants (allele *4 and *22) in patients     will increase the metabolism of bupropion in the GI tract and liver, reduce both local     concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when     bupropion is released earlier in GI tract   "
92283|NCT02078167|"     Background: Statins are at the forefront of strategies to manage hypercholesterolemia.     However, 10-15% of patients result to be intolerant to any statins, even at low daily doses     and almost one- third of statin users discontinue therapy within one year. Some     nutraceuticals are prescribed as lipid- lowering substances, but doubts remain about their     efficacy and tolerability. In this study we investigated the effects of a nutraceutical     combination consisting mainly of red yeast rice extract 200 mg (equivalent to 3 mg     monacolins), berberine 500 mg and policosanols 10 mg (MBP-NC).      Methods: In this single centre, randomized, double-blind, placebo-controlled study 60     consecutive outpatients (age range: 18-60 years), with newly diagnosed primary     hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable     hypolipidic diet, were randomized to receive a pill of MBP-NC (N=30) or placebo (N=30) once a     day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of     the proposed nutraceutical treatment were fully assessed after 4, 12 and 24 weeks of     treatment.   "
92284|NCT02078154|"     Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest®     D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein     Thrombosis (DVT) Data from this study may be used in conjunction with data from the     prospective study entitled STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism     (VTE), NCT01221805, the DiET study,   "
92285|NCT02078141|"     18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a     promising tool for identification of myocardial inflammation in patients with dilated     cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the     fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the     frequency and describe the different binding profiles in comparison with MRI data.      Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.      All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A     high fat and low carbohydrate diet and an heparin injection will be prescribed to patients     before this FDG PET.      Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be     completed by a 12 months evaluation.   "
92286|NCT02078128|"     The purpose of this study is to determine the effect of β-glucans on wound healing.   "
92287|NCT02078115|"     The purpose of this study is to find the change of blood pressure (BP) control pattern (true     controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper,     reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3     years. And Other objective is the relationship between the BP control pattern and the target     organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so     on. In addition, we will find clinical factors related to the BP control pattern.   "
92288|NCT02078102|"     The trial is an open label Simon optimal two-stage Phase II trial of fixed doses of oral     meloxicam and subcutaneous filgrastim to assess the safety and efficacy in mobilizing     autologous peripheral blood stem cells (PBSC) from multiple myeloma (MM) and non-Hodgkin's     lymphoma (NHL) patients planning to undergo high-dose chemotherapy with stem cell support.     Clinical data regarding the cellular composition and function of the graft mobilized by this     combination will be obtained.   "
92291|NCT02078063|"     Use of long acting reversible contraception (LARC) such as implants or intrauterine     contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of     being independent of user error and are considered to be underused, especially among young     individuals where oral methods have high rates of user failure. IUC is often underused in     young or nulliparous women due to fear of pain at insertion.      10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the     uterine cavity through a hydrosonography catheter before the tenaculum has been applied but     prior to sounding and to insertion of the IUC.      The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a     hydrosonography catheter prior to any instrument placement will provide more effective pain     relief than instillation of 10 ml placebo (sodium chloride 9mg/ml).      Primary objective: To evaluate the difference in pain score at the time of the insertion of     the IUC between treatment and control group.      Secondary objectives: To evaluate acceptability of the procedure.   "
92313|NCT02077777|"     The purpose of this study is to obtain an in vivo confirmation that mesalazine induces the     gene expression of μ-protocadherin and other related genes in the colon mucosa, as     demonstrated in some in vitro experiments. .   "
92314|NCT02077764|"     Objective:        -  To assess the relationship between coronary allograft vasculopathy (CAV) and graft          function, and to evaluate non-invasive methods for CAV diagnosis.        -  To assess left ventricular (LV) and right ventricular (RV) function in the acute phase          and serially during the first year after transplantation.        -  To evaluate the impact of acute and repetitive rejection on the longitudinal myocardial          function Hypothesis             1. Timing of development and degree of CAV can be measured non-invasively combining               myocardial longitudinal deformation (by advanced echocardiography) and coronary               flow velocity reserve (CFVR) (by echocardiography and PET). This combination of               methods can detect CAV before it is angiographically visual and gives supplementary               information of the impact on myocardial graft function.             2. Longitudinal deformation, 3D echocardiography, cardiac magnetic resonance imaging               (CMRI) and PET can be used for RV and LV myocardial function assessment and               represent more valid markers of the function than standard echocardiography in               heart transplant (HTX) patients.             3. Myocardial longitudinal deformation is a better marker of acute rejections than               conventional ejection fraction (EF).      Background The most frequent heart related death causes after HTX are CAV, acute graft     failure and rejection.      CAV is characterized by diffuse concentric intima thickening involving both epicardial     vessels and the coronary microvascular system. In our clinical approach HTX-patients are     followed with annual CAG and standard echocardiography with estimation of LV systolic     function by EF. Standard echocardiography has not proven benefit in the diagnosis of CAV. CAG     often misses CAV in early phases.      In various cardiac diseases it is well known that ischemia and fibrosis often affect the     endocardial longitudinal oriented layers. Longitudinal deformation by advanced     echocardiography has shown to be better markers for systolic function in HTX patients     compared to standard EF. Longitudinal LV systolic function is dependent of endocardial     perfusion. CFVR represents the capacity of the coronary circulation to dilate due to     metabolic demands and has been shown to correlate with longitudinal deformation in myocardial     infarction. CFVR measurements in HTX patients with advanced echocardiography and PET scan     have shown a significant correlation to CAV.      RV failure is an early, potentially fatal, complication to HTX. The function and change over     time of RV have not been fully studied using modern echocardiographic techniques or     assessment by CMRI.      Acute rejection is an inflammatory response often diagnosed by routine biopsies (gold     standard). These are expensive, time consuming and inconvenient for the patient. The role of     conventional echocardiography has not yet found a significant role in the diagnostics of     acute rejections and furthermore how repeated rejections influence on graft function is not     well described.      Study 1 A cross sectional study consisting of 50 stabile HTX patients. These will be selected     with 25 patients with no or light CAV and 25 patients with moderate or severe CAV.      Severity of CAV will be evaluated by:        -  CAG        -  CFVR measurement by advanced echocardiography and PET.      Graft function will be evaluated by:        -  Advanced echocardiography at rest end during bicycle exercise.        -  CMRI including assessment of LV and RV EF, strain and mass.        -  During rest and bicycle exercise echocardiography simultaneously right heart          catheterization are performed for hemodynamic measurement      Study 2 A prospective cohort study with 20-25 newly transplanted patients over a period of 12     months.      LV and RV function will be measured by:        -  Advanced echocardiography        -  CFVR measurement (echocardiography and PET)        -  CMRI for LV and RV EF, strain and mass        -  Right heart catheterization      Study 3 Prospective examination of correlation between graft function, CAV and rejection.     Information of former episodes of acute rejection is collected retrospective. Study     objectives are all living HTX patients (approx. 200) in the period of 2011-2013.      Advanced echocardiography (including longitudinal deformation), biopsies (rejection     evaluation) and CAG (CAV evaluation).   "
92295|NCT02078011|"     The purpose of this study is to test an investigational device called the Echopulse for     treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast     tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in     groups, or as a complex of lumps together. Sometimes women feel these in the breast when     doing regular self breast exams, or they may be found during a routine mammogram. Some are     small (less than an inch in size), and others are quite large (the size of a lemon or     larger).      This is a study about the Echopulse device, a computer driven system which uses ultrasound to     guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the     breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes     the cells to die and allows the possibility to treat the fibroadenoma without the need for     surgery.   "
92296|NCT02077998|"     This phase 0/II trial studies the effect of carbon C 14 oxaliplatin in tumor tissue and blood     and the side effects and how well oxaliplatin works in treating patients with metastatic     breast cancer. DNA analysis of tumor tissue and blood samples from patients receiving carbon     C 14 oxaliplatin may help doctors predict how well patients will respond to treatment with     oxaliplatin. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.   "
92297|NCT02077985|"     The goal of this project is to collect information that will support a later clinical trial     on the effectiveness of a specially adapted dental environment for children who have     difficulty tolerating oral care in the dental clinic. We hypothesize that adapting the     sensory environment in the dental office by modifying the sounds, sights, smells and tactile     experiences will result in decreased anxiety, increased cooperation, and fewer behavior     problems for children with Autism Spectrum Disorders, and to a lesser extent for typically     developing children especially those who have dental anxieties. This has the potential     contribute to increased child comfort as well as safer, more efficient, and less costly     treatment for a large population, as potentially more than one-fourth of all children may     benefit from a sensory adapted dental environment.   "
92298|NCT02077972|"     Combat-related post traumatic stress disorder (PTSD) has become an increasingly pressing     public health problem in the United States following the overseas wars of the last decade.     Rates of PTSD have skyrocketed in the military and among veterans, leading to increased rates     of suicide, impairment on the job and off, and behavioral changes that negatively affect not     just the veteran, but also his or her family. Although effective medication and psychotherapy     treatments exist for combat-related PTSD, many individuals suffering with PTSD do not     adequately respond to currently available treatment options, highlighting the need to develop     and test new interventions for the disorder. To address this pressing clinical issue, the     investigators will conduct a pilot study to determine if Whole Body Hyperthermia (WBH)     reduces symptoms in adults suffering from combat-related PTSD. The investigators plan to     recruit a sample of 10 medically healthy individuals with combat-related PTSD who will     receive a single session of WBH to determine if this single session improves PTSD symptoms     and, if so, whether this improvement will last at least 2 weeks. To do this, the study will     include basic clinical and psychiatric assessments immediately before and one and four weeks     after WBH. Because sleep is so often impaired in PTSD, the investigators will measure at-home     sleep patterns for a week prior to and a week following the WBH session using sleep diaries     and a wristwatch actigraphy device. Given scientific evidence from our research group that     WBH may improve depression, the investigators anticipate that it may also be of benefit or     adults suffering from combat-related PTSD.   "
92299|NCT02077959|"     This phase I/II trial studies the side effects and best dose of lenalidomide and pidilizumab     and to see how well they work in treating patients with multiple myeloma that has come back     (relapsed) or has not responded to treatment (refractory). Biological therapies, such as     lenalidomide, may stimulate the immune system in different ways and stop cancer cells from     growing. Monoclonal antibodies, such as pidilizumab, can block cancer growth by blocking the     ability of cancer to grow and spread. Giving lenalidomide with pidilizumab may work better in     treating relapsed or refractory multiple myeloma.   "
92300|NCT02077946|"     This trial is conducted in Europe. The aim of this study is to investigate a retrospective     database assessment of clinical effectiveness in type 2 diabetes patients treated with     liraglutide from primary care centers in Sweden.   "
92301|NCT02077933|"     Dose escalation part: to determine the highest dose of alpelisib administered on a daily     basis when given in combination with daily everolimus or in combination with daily everolimus     and exemestane.      Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or     alpelisib, everolimus and exemestane combinations.   "
92310|NCT02077816|"     This is a pilot study which aims to show the temperatures measured on body surface with an     infrared thermometer on inpatients who need a central venous catheter (CVC) for medical care.     Because the local temperature could be altered, at least during local infectious processes,     seems to be reasonable to think that this approach could be helpful to its early diagnosis.   "
92302|NCT02077920|"     Ventilator-associated pneumonia (VAP) is common in patients receiving mechanical ventilation,     and is associated with longer hospital stay, increased treatment costs, and higher rates of     morbidity and mortality . VAP is reported to occur in 8%-67% of mechanically ventilated     patients (20%-28% in most reports) and has a mortality rate of 24%-50%, which is 2-3 times     the mortality rate of mechanically ventilated patients without VAP. In patients infected by     multi-resistant bacteria, the mortality rate may be as high as 76%. The diagnosis, treatment,     and prevention of VAP are therefore important. Strategies for preventing VAP are crucial for     reducing medical costs and increasing survival rates in critically ill patients. These     strategies mainly involve a semi-reclining position with the head of the bed raised to at     least 30°-45°, oral care, suctioning of subglottic secretions, selective decontamination of     the digestive tract, proper hand washing, avoidance or reduction of proton pump inhibitors,     avoidance of excessive sedation, and control of plasma glucose levels.      At our center, VAP is mainly caused by bacterial colonization of the upper respiratory tract     via aspiration. This study will compare four interventions including oropharyngeal     decontamination and subglottic suctioning by bronchoscopy, with the aim of developing a     prevention strategy to minimize the development of VAP during mechanical ventilation.   "
92316|NCT02077738|"     The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation     (HFCWO) in prolonged mechanical ventilation patients remain unknown. This study aimed to test     the hypothesis that HFCWO could produce greater clearance volume of sputum, greater     improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success     rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with intra-tracheal     intubation.   "
92303|NCT02077907|"     The objective of this study is to test and compare the effectiveness and cost-effectiveness     of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal     programmatic settings in Sierra Leone. Study participants will receive one of four test foods     varying in energy and nutrient density as well as amounts provided.        1. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group)        2. Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g          sugar, per day        3. Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day        4. Plumpy'Sup - 500 kcal/d, 92 g/d      This will be a prospective, randomised, controlled effectiveness trial.      Aims        1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of          moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.        2. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered          from MAM, relative to comparison group, SC+) of implementing the feeding program using          each commodity, taking into consideration costs of procurement/production and          distribution        3. (Process) To evaluate the determinants of effectiveness including: consumption          adherence, preparation compliance, targeting/sharing of supplement, food components and          preparation, adverse effects of foods, water contamination, hygiene and health          behaviors, SES, food security, perceived barriers      Outcomes        1. Recovery from MAM             1. Percent of children recovered from MAM (defined as achieving mid-upper arm               circumference (MUAC) ≥ 12.5 cm by 12 weeks once)             2. Percent default/non-response: children who do not recover after 12 weeks             3. Percent relapse: children who become MAM again within 6 months of recovery        2. Mean number of weeks to recovery      Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or     Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus.      Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup     will have different recovery outcomes to those children fed Super Cereal Plus.   "
92304|NCT02077894|"     Objective: The objective of this study is to identify genetic causes of inherited eye     conditions through whole exome or whole genome sequencing. This includes identifying     mutations in known genes or novel genes for recognized conditions, as well as identifying     mutations in novel genes for previously uncharacterized genetic conditions involving the eye.      Study Population: We plan to recruit 310 participants, to include both probands with an eye     condition under study and unaffected family members. Ideally unaffected family members will     be parents of a proband.      Design: Participants will be recruited through other pre-existing NIH protocols, such as the     NEI Evaluation and Treatment protocol (08-EI-0169), the NEI Screening protocol (08-EI-0102),     and the Genetics of Uveal Coloboma protocol (13-EI-0049). Self-referred patients or patients     referred by an outside clinician will be screened for eligibility under a pre-existing NIH     protocol. Phenotyped patients eligible for participation and their unaffected family members     will undergo genetic counseling and will provide a blood sample for exome or genome     sequencing. Biological relationships will be confirmed prior to exome or genome sequencing.     Sequence data will be analyzed for primary variants associated with the proband s eye     condition and incidental findings, as recommended by the American College of Medical Genetics     guidelines. All sequence variants deemed clinically relevant will be validated in a     CLIA-certified laboratory and the results will be returned to the participant in-person.      Outcome Measures: This is an etiologic study that will generate molecular information about     previously-recognized conditions for which participants did not have a molecular diagnosis,     as well as molecular information for previously uncharacterized conditions involving the eye.   "
92305|NCT02077881|"     This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT)     and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent     indoximod when administered in combination with standard of care chemotherapy gemcitabine     plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects     will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in     doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.   "
92306|NCT02077868|"     The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a     maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal     cancer.   "
92307|NCT02077855|"     This fracture of the distal tibia occurs in 1 to 4 year-old-children. Timely diagnosis is     important, because it obviates the need for investigations to archive adequate treatment as     well as to prevent unnecessary immobilization. The value of sonographic diagnosis of     toddler's fracture has been demonstrated. The aim of the present study is to investigate the     reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.   "
92308|NCT02077842|"     The purpose of this study is to determine whether prophylactic nasal continuous positive     airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative     pulmonary function following elective bowel surgery. The investigators hypothesize that one     hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2)     when compared to the standard treatment of low flow oxygen applied by face mask.   "
92309|NCT02077829|"     The purpose of this study is to examine the barriers and facilitators of implementing Illness     Management and Recovery (IMR) in Norwegian mental health services.   "
95640|NCT02034279|"     The aim of this study is to evaluate whether albumin administration improves short-term     survival in patients with advanced cirrhosis and bacterial infections other than Spontaneous     Bacterial Peritonitis (SBP).   "
92312|NCT02077790|"     This study is to support the substantial equivalence of the SS-1000 to the predicate device     Pentacam.      Primary Objective -The primary objective of the trial is to evaluate the precision of the     SS-1000 and Pentacam in measuring the anterior segment parameters in an eye, including     Corneal Curvature, Corneal Thickness, Anterior Chamber Depth and Cornea Volume.      Secondary Objectives        -  To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in measuring          the anterior segment parameters in an eye        -  To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in          measuring the anterior segment parameters in an eye        -  To investigate the agreement between SS-1000 and Pentacam in measuring the anterior          segment parameters in an eye      Study design      -The trial design is a prospective precision trial with the following factors: The trial will     be conducted at one investigational site. The site will have three SS-1000 devices and three     Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly     assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are     confounded with instrument effect. All participants will have one visit and undergo the same     set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).   "
92317|NCT02077725|"     Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a     patient-centered medical home      Objectives:      The primary objective of this project will be to track the types of interventions made in an     interdisciplinary polypharmacy clinic to improve medication regimens and medication burden.     Polypharmacy has been well documented in the literature as a risk for medication errors,     adverse drug events, and morbidity. Team visits, including complete medication reviews, by     pharmacists and physicians within a National Committee for Quality Assurance (NCQA) tier 3     patient-centered medical home (PCMH) at an academic medical center, can improve medication     regimens. Secondary objectives include (1) measuring each patient's quality of life at     baseline and one month post-intervention and (2) tracking the cost of medication additions     and discontinuations.      Methods:      Patients taking ten or more chronic medications will be identified for referral to the     polypharmacy clinic from a report generated from the electronic medical record. The     polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from     an attending physician who specializes in geriatrics. Drug-related problems identified during     the visit will be resolved and categorized based upon indication, efficacy, cost, safety, and     compliance. The numbers and types of interventions made, both during the primary visit and     anticipated in the future, will be tracked. The 12-item short form (SF-12) survey will also     be administered at baseline and one month post intervention. The increase or decrease in cost     for medications added and removed during these visits will be captured using the average     wholesale prices.      Preliminary Results Using descriptive statistics, the types of drug-related problems     identified and interventions made will be reported. Changes in quality of life and monthly     medication costs will also be described.   "
92318|NCT02077712|"     2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children     for ophthalmic examinations than the sedative effect of 1ug/kg.   "
92319|NCT02077699|"     The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei     DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome.     After that, the secondary object is to evaluate if the reduction of painful symptoms is     related to a relevant reduction of trypsin and tryptase in colonic mucosa.   "
92320|NCT02077686|"     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly     developed treatment and education module will be tested compared to a waiting-list control     group. The module covers the topic diabetes and travel. Primary outcome variable is     diabetes-specific empowerment regarding diabetes and travel. Secondary outcome variables are:     diabetes-related distress, health-related quality of life, depressive symptoms, self-care     behavior, and glycemic control.   "
92321|NCT02077673|"     Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a     massive surgical intervention. Currently, gastroesophageal cancer surgery is performed with     upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology,     Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted     laparoscopy, is in the progress of being implemented in this field as they are hypothesized     to be more beneficial for the patients, and in some aspects better than conventional     laparoscopic surgery.      The operative procedure is often complicated by low blood pressure (systolic blood pressure     less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably     accompanied by a reduced splanchnic microcirculatory flow, leading to increased morbidity.     Hypotension may be due to several factors, among them are epidural analgesia, mesentery     traction reflex, and inflammatory and vasoactive hormones.      Aim of the project      The aim of the project is, through a series of sub-projects, to validate or invalidate the     relationship between changes in the microcirculatory blood flow in the stomach and the     systemic hemodynamic changes. Furthermore, the aim is to assess the changes in the     microcirculatory blood flow as a consequence of the thoracic epidural anesthesia. In     addition, the aim is to assess the hypothesis that the mesenteric traction reflex and changes     in the PGI2 levels may influence systemic hemodynamic changes, and that robotic assisted MIT     will attenuate the mesenteric traction reflex and changes in PGI2 compared to open surgery.   "
92322|NCT02077660|"     The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks)     green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and     antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric,     inflammation and metabolic parameters in a healthy aging men and women.   "
92323|NCT02077647|"     The primary objective of this registry is to assess the functional outcome measured with the     Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental     osteoarthritis and osteonecrosis of the knee treated conservatively. The aim of the Focused     Registry is to complete the data collection and enable a sound analysis for the Tomofix Small     size study.   "
92324|NCT02077634|"     This is an exploratory Phase 2 multicenter, randomized, open-label study with a randomization     allocation ratio of 1:1 [abiraterone acetate + prednisone + LHRH-therapy (Arm A) versus     abiraterone acetate + prednisone (Arm B)]. For both groups patients will receive a dose of     1000 mg abiraterone acetate and 10mg prednisone daily (QD). Study drug will be administered     as 4 x 250-mg abiraterone acetate tablets and prednisone will be administered as 5 mg orally     twice a day (BID). Patients randomized to the LHRH-therapy group will receive the same     LHRH-therapy they received prior to entering the trial. 70 medically castrated male patients     with metastatic CRPC who have shown tumor progression and are non- or mildly-symptomatic will     be enrolled from approximately 12 German study sites.   "
92405|NCT02076581|"     It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to     neurological injury. This makes it difficult to evaluate therapies that aim to reduce the     effects of abnormal muscle tone. This research study will evaluate the feasibility of a     clinician worn device to capture and quantify features of spasticity and dystonia.   "
92325|NCT02077621|"     PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer patients.     The primary objective of this study is to evaluate the efficacy of PG2 on fatigue relief in     patients undergoing palliative abdominal surgery for cancer. The secondary endpoints,     including the length of hospital stay, postoperative complications, HRQL, inflammatory     biomarkers, the duration of antibiotic therapy, mortality during the hospital stay, weight     loss and body composition, will be evaluated among these patients.   "
92326|NCT02077608|"     Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media     and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer     are incubated in a culture media containing high concentration of hyaluronan or low     concentration of hyaluronan.      Primary outcome: implantation and pregnancy rates   "
92352|NCT02077270|"     The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain     during the exam.   "
92389|NCT02076789|"     This study has been designed to prospectively estimate long term complication rates     (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD)     replacement, with and without a planned transvenous lead addition for replacement or upgrade     to a device capable of additional therapies; the study also evaluates the predictors of     complications, the patient's management before and during the replacement procedure in     clinical practice and the estimated costs related to the use of health care resources.   "
92327|NCT02077595|"     Recently, non-invasive brain stimulation has become a powerful tool in both basic research     and clinical application. Among several non-invasive brain stimulation techniques,     transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS)     have received the most attention. About DC stimulation, the change of polarity could modulate     the spontaneous neuronal activity and make effect on decision making, language, memory,     sensory perception, and pain. In spite of that the concept of transcranial alternating     current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches     have revealed that AC might potentially have the effect on the cortical excitability.     However, there are still many areas about AC stimulation which remain unknown, such as     mechanism, application, and potential influence on cortical excitability.   "
92328|NCT02077582|"     The objective of this trial is to visualize blood brain barrier function and metabolic     changes in the first days after ischemic stroke with new investigational MRI sequences.   "
92329|NCT02077569|"     To compare the effect of four and a half days treatment of a range of doses of AZD5363 on     selected markers of the AKT pathway and anti-proliferation compared with placebo in oestrogen     receptor positive breast cancers.      To assess the tolerability of four and a half days treatment of AZD5363.   "
92330|NCT02077556|"     The purpose of this study is to understand the effects of everolimus on tacrolimus     pharmacokinetics (pk) in patients receiving de novo kidney transplants.   "
92331|NCT02077543|"     The purpose of the study is to determine the innocuity and operability of the innovative     tumor molecular and cellular print ProTool.   "
92332|NCT02077530|"     Patients with metabolic syndrome living in Seoul area are included in this prospective     registry for more than 10 years. All enrolled patients undergo thorough medical history     survey. Enrolled patients will have coronary CT, 2D echocardiogram, treadmill test, pulse     wave velocity, augmentation index, carotid intima-media thickness, and abdominal fat mass     evaluation. Moreover, lipid profiles and inflammatory markers such as hsCRP, IL-6, TNF-alpha,     VCAM-1, ICAM-1, adiponectin, MMP-9 will be measured. All participants will repeat the test     and survey every year in Korea University Hospital.   "
92333|NCT02077517|"     The purpose of this study is to compare postoperative complications between hand sewn and     stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid     obesity.   "
92334|NCT02077504|"     The purpose of this study is to determine the correlation between functional MEG analysis of     the tumor and its periphery and the tumor stage and treatment response.   "
92335|NCT02077491|"     The purpose of this study is to determine the effect of a high-protein diet during     hospitalization in combination with resistance training and a daily protein and energy     supplement three months after discharge on the muscle mass, muscle strength, functional     ability and weight in acutely ill old medical patients.   "
92336|NCT02077478|"     test the following differences between Schinder's Target Controlled Infusion (TCI ) model and     manually controlled infusion (MCI) :        -  remifentanil and propofol total dose given        -  incidence of awareness or inadequate anesthesia        -  number of rescue dose given   "
92337|NCT02077465|"     This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple     infusions of GS-5745 in participants with chronic obstructive pulmonary disease (COPD) as     assessed by adverse events (AEs) and laboratory abnormalities.   "
92338|NCT02077452|"     The objectives of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2     diabetes mellitus.   "
92339|NCT02077439|"     The goal of this study is to determine robotic hand system is more effective than     conventional physical and occupational therapy at promoting functional recovery of the     affected arm in subjects after stroke.   "
92340|NCT02077426|"     The aim of this study is to determine whether heart failure patients can tolerate a     four-weeks of a new exercise training regimen that targets peripheral tissues (Regional     Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic     capacity and strength in healthy subjects aged 70+years who were at risk for losing     functional independence.   "
92385|NCT02076841|"     To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS     (Multiple Sclerosis) participants who have been switched - due to persistent tolerability     issues, particularly injection problems - from a subcutaneous injectable disease-modifying     treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly     Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex     Pen.   "
92386|NCT02076828|"     The aim of the present study was to compare the effectiveness of the different oral iron     preparations in children with IDA.   "
92623|NCT02073734|"     The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will     benefit patients' perceived quality of recovery after surgery.   "
92341|NCT02077413|"     The overall goal of this study is to establish a new pre-rehabilitation program in the     prevention of muscle injury in the legs of healthy people serving in the military and injured     individuals with muscle wasting following leg injuries. The specific goals include: 1) the     amount of exercise that causes injury to healthy muscle in the lower leg of healthy people;     2) what is the effect of an intervention (pre-rehabilitation program) on decreasing how     easily the muscle of the lower leg can be injured in healthy people; 3a) what amount of     exercise causes injury to muscle that has recently been injured and is recovering and 3b) the     effect of the new pre-rehabilitation program on the muscles of the lower leg when the muscle     has recently been injured and is still recovering.      For the first goal, the investigators will determine how easily the muscle can get injured     from a specific exercise in 6 healthy, conditioned men and women. Participants will perform     different amounts of exercise with the lower leg muscles to see how easily the muscle can be     damaged. Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs     with the different levels of exercise. For the second goal, the investigators will examine     the effect of a new pre-rehabilitation program on decreasing how easily muscle gets damaged     from the exercise we did in the first goal. The investigators will invite healthy people to     participate in this goal. The investigators will use MRI, blood markers, and pain as ways of     assessing muscle damage in 10 people who do the pre-rehabilitation program before exercising     and 10 who do not do the new program. The third goal will focus on a) determining how easily     muscle gets injured that has recently recovered from some trauma (5 people will participate     in this part of the third goal), and b) determining how a pre-rehabilitation program     decreases how easily a muscle that has just recovered from trauma gets injured from exercise     (10 people will participate in this part of the third goal).   "
92342|NCT02077400|"     Fingertip amputation is a common injury. Considerable controversy exists as to whether     prophylactic antibiotics are necessary for this injury. The investigators goal was to compare     the rate of infections among subgroups with and without prophylactic antibiotic treatment.     The study hypothesis was that infection rates were similar in the two groups.   "
92371|NCT02077023|"     The purpose of the study is to estimate the contemporary prevalence of cardiovascular     diseases in the United Kingdom (UK) and to describe the incidence and prevalence of stroke,     mini stroke (TIA), Heart Attack (MI), deaths and interventions repairs for carotids and     occlusive arterial disease in a large population. This study will also allow us to obtain     reliable information on the age- and sex-specific relevance of tobacco and alcohol     consumption, obesity, diabetes and blood pressure as risk factors for different     cardiovascular diseases. By following up a large group of participants for 5 years, we will     be able to estimate the annual risk of stroke and other CVD events associated with     asymptomatic carotid artery stenosis and atrial fibrillation.   "
92390|NCT02076776|"     The purpose of this study is to gain a better understanding of how different types of     exercise can help people after a stroke. The investigators want to study if different types     of exercise will improve the use of arm and hand function after a stroke.   "
92343|NCT02077387|"     Today's environment provides many hedonic stimuli that promote consumption of unhealthy     energy-dense snack foods. It is widely recognized that a systems approach is required to deal     with this complex problem. However, individuals, particularly children, also need to develop     the personal capacity to deal with tempting stimuli and inhibit responses to these     energy-dense foods. Therefore in this proposal, we will focus on enhancing higher level     executive functions, particularly inhibitory control, which is needed to counterbalance     impulsive behavior and is crucial for growth and development. We have chosen to focus on     developing inhibitory control in preschool-age children because executive     functioning/inhibitory control and eating habits are developing at this time. Among     preschool-age children, inhibitory control is fostered through social play-based curriculums     and has been found to be related to greater school readiness and academic skills. Therefore,     the goal of this proposal is to adapt a play-based curriculum, the Tools of the Mind program,     to promote greater inhibitory control skills in preschool children and decrease consumption     of energy-dense snack foods. In Phase I, we will develop and pilot a Child Inhibitory Control     Play-based Program (CHIC Play) among children age 4- to 6-years old. We will adapt the     learning tools used in the Tools of the Mind curriculum and employ naturalistic play     scenarios, drawings (visual support), and games to teach children to inhibit their responses     to energy-dense snack foods. Once developed, we will test the efficacy of CHIC Play in the     preschool setting. Parent groups will also be conducted to support the adoption of these     skills at home. The primary outcome of interest is caloric intake and age- and     gender-adjusted percent of daily caloric intake as measured by the Eating in the Absence of     Hunger (EAH) free access procedure and a snack time procedure. Inhibitory control skills will     also be measured using executive functioning tasks. Feasibility and acceptability of this     program will be determined from parent, child, and teacher surveys. The purpose of this study     is to develop a new innovative method of decreasing energy-dense snack food consumption by     promoting the development of inhibitory control or impulse control. If successful, this     program has the potential to play a role in the treatment and prevention of childhood     obesity.   "
92344|NCT02077374|"     The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to     placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and     with abnormal liver tests   "
92345|NCT02077361|"     A project has been developed in Edmonton, Alberta, Canada to enable male patients with     choroideremia to access a clinical trial that replaces the defective gene with a normal copy.     This experiment is designed to show that the transfer of a normal copy of the gene to the eye     is not only safe but may improve the sight of patients. Only Canadian subjects who meet     criteria will be recruited.   "
92346|NCT02077348|"     Diabetes mellitus type I (DM I) is characterized by lack of endogenous insulin and these     patients are 100% dependent on insulin substitution to survive.      Insulin is a potent anabolic hormone with its primary targets in the liver, the skeletal     muscle-tissue and - adipose-tissue.      Severe lack of insulin leads to elevated blood glucose levels, dehydration, electrolyte     derangement, ketosis and thus eventually ketoacidosis.      Insulin signalling pathways are well-known.      Growth hormone (GH) is also a potent anabolic hormone, responsible for human growth and     preservation of protein during fasting. GH (in concert with lack of insulin) induces     lipolysis during fasting. It is not known how GH exerts its lipolytic actions.      The aim is to define insulin and growth hormone (GH) signalling pathways in 3 different     states in patients with DM I.      And to test whether ATGL-related lipolysis in adipose tissue contributes to the development     of ketosis.        1. Good glycemic control        2. Lack of insulin (ketosis/ketoacidosis)        3. Good glycemic control and GH injection   "
92347|NCT02077335|"     The purpose of this study is to determine the clinical efficacy and toxicity of High-dose     rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk     prostate cancer.   "
92348|NCT02077322|"     Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients     who suffer from sinus disease. Synechiae formation in the nose is the most common     complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal     surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage.     Spacers are often inserted during surgery between nasal mucosal surfaces to prevent     synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing     the formation of synechiae after sinus surgery than a merocel spacer.   "
92349|NCT02077309|"     Examination of the effect of Linagliptin versus placebo for 6 months on vascular inflammation     of the carotic artery and on abdominal adipose tissue inflammation in patients with diabetes     mellitus type 2. The effect will be assessed by FDG-PET scan.      Furthermore the effect of Linagliptin on the vessel wall volume of the carotid artery will be     assessed by MRI scan and biomarkers of vascular inflammation will be analyzed in blood     samples.   "
92403|NCT02076607|"     Evaluate the correlation between the structural changes of fractures of the thoracic and     lumbar spine burst type with clinical outcome of the treatment.   "
92350|NCT02077296|"     Rationale and background: Predictive factors are needed to discriminate chemoradiotherapy     responders from non-responders and to individualize the treatment regime. Various cytokines     play a role in processes affecting tumour growth and metastasis. Furthermore, cytokines might     influence treatment response. Various cytokines are abnormally expressed in colorectal cancer     patients, are associated with colorectal cancer or determine response to chemoradiotherapy.     Therefore the investigators want to investigate whether levels of circulating cytokines could     predict response to preoperative chemoradiotherapy in patients with rectal cancer.      Hypothesis: The investigators hypothesis is that the varying levels of circulating cytokines     in the blood of rectal cancer patients may predict the response to preoperative     chemoradiotherapy.      Study design: This study is an explorative clinical pilot study in which the investigators     will collect 4 ml of blood from a selection of rectal cancer patients during a regular     venipuncture before, during and after preoperative chemoradiotherapy and before and after     surgery. Cytokines will be measured in blood plasma and in tumour and healthy tissue from the     resection specimen using multiplex immunoassays. Plasma cytokine measurements will be linked     to pathological response to identify which cytokines and corresponding levels can predict     response to preoperative chemoradiotherapy for patients with locally advanced rectal cancer.     Furthermore, blood plasma cytokine measurements before and after surgery will be compared to     evaluate the effect of tumour resection on the immune response. In addition, preoperative     blood plasma cytokine levels will be compared with cytokine levels in normal and tumour     tissue to test whether circulating cytokine levels are representative for tissue cytokine     levels.      Study population: Thirty patients (≥18 years) with locally advanced rectal adenocarcinoma     eligible for preoperative chemoradiotherapy (oral capecitabine and 45-50 gray (Gy) in total;     fractions of 1.8-2 Gy) and surgery.      Country of recruitment: The Netherlands   "
92351|NCT02077283|"     NAFLD(non-alcoholic fatty liver disease, NAFLD) is a common liver disease with a high     morbidity which seriously influence people's health. In clinical, there are two major     Traditional chinese medicine(TCM) patterns which are the pattern of liver depression and     spleen deficiency and pattern of damp-heat in the interior, According to TCM patterns, the     treatment is effective, but not used worldwide. While the development of metabonomics     provides a tool to investigate the correlation of TCM patterns and metabonomics which will     promote the further development of TCM.      Currently researches on NAFLD patterns based on metabolomics were limited. Our study was     undertaken to investigate the correlation of TCM patterns and metabonomics, to evaluate the     application of urinary metabonomics in NAFLD: whether it can be used in TCM patterns     auxiliary classification of NAFLD. In addition, the investigators also aim to discover novel     biomarkers for the noninvasive early diagnosis of nonalcoholic fatty liver disease (NAFLD).      In this study, urine samples from humans of three divided groups (healthy controls, the group     of liver depression and spleen deficiency pattern and group of damp-heat in the interior     pattern) were collected, then 4℃, 15 min 3000 rpm centrifuged and - 80℃ cryopreserved. The     metabolic profile changes were analyzed by Gas Chromatograph-Mass Spectrometer(GC/MS) with     principal component analysis (PCA), partial least squares-discriminate analysis (PLS-DA) and     orthogonal partial least squares-discriminate analysis (OPLS-DA). Furthermore, biochemical     examination were also carried out to compare among these three groups.      Base on literature survey, the investigators inferred that there should be metabolic     differences between the two patterns of NAFLD. If the investigators hypothesis is correct,     the investigators can find different metabolites which can be used discriminate between NAFLD     and healthy population, different patterns through urinary metabonomics.      The results will be attractive which mean a lot: it will prove the importance of the four     diagnosis methods of TCM used in differential analysis by metabonomics; it will validate the     classification of TCM syndromes is scientific; it will shed light in the study of TCM     syndromes; it will find biology markers to help diagnosis, treatment and pattern     discrimination.   "
92353|NCT02077257|"     This is a 12-week, randomized, open-label,,multicenter, Phase IV study exploring LDL-C     lowering efficacy of Rosuvastatin 20 mg/d compared to 10 mg/day Chinese ACS patients.The     Randomized Treatment Period is preceded by a 24hours Screening Period. The study flow chart     (Figure 1) depicts the 2 periods which comprise the study. These periods are described as     follows:        1. Screening Period (Day -1 through Day 1) This period consists of Visits 1 and 2. Subjects          entering the Screening Period are required to meet the inclusion criteria. All subjects          will be instructed to follow the current TLC(therapeutic lifestyle change)dietary          guidelines for the duration of the trial.        2. 12-week Randomized Treatment Period (Day 1 through Week 12) This period consists of          Visits 2, 3, 4, and 5. Eligible subjects will be randomized at Visit 2 to each treatment          group: Rosuvastatin 20 mg orRosuvastatin10 mg. Treatment will be administered once daily          for 12 weeks.      A total of 450valid subjects in each of the Rosuvastatin arms are required, in order to test     the hypothesis of superiority for comparison of LDL-C levels between Rosuvastatin20 mg and     Rosuvastatin10 mg(see Section 6.1 for more details).      The Study visit schedule(Table 2) indicates the number and timing of the planned visits. The     visit schedule must be within time window. At the final visit, it is the responsibility of     the investigator to ensure the subject is offered an selected appropriate type of     lipid-lowering therapy.      Scheduled Visit3,4,5 will have a visit window of ±2 days. Subjects who attend a clinic visit     without fasting (at least 12 hours) should be asked to return within 2 days for another     clinic visit after fasting for at least 12 hours.   "
92354|NCT02077244|"     To investigate the effect of nurse led follow up talks to prevent posttraumatic stress (PTS)     symptoms and improve quality of life after an intensive care unit (ICU) stay.      Secondly:      Investigate level of psychological distress, quality of life, hope and work participation in     ICU patients after an ICU stay and factors associated with these outcomes.   "
92355|NCT02077231|"     Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular     surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to     search for new drugs for therapy. The investigators hypothesized that the artificial tears     containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in     common use and had already been tested in animals.   "
92356|NCT02077218|"     This pilot clinical trial studies computed tomography (CT) scans and biomarker analysis in     diagnosing coronary artery disease (CAD) in patients who have undergone a stem cell     transplant but have no symptoms of CAD. CAD is a disease in which there is a narrowing or     blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart)     and patients who have undergone a stem cell transplant are at an especially high risk for     CAD. A CT scan involves a series of detailed pictures of areas inside the body taken from     different angles. The pictures are created by a computer linked to an x-ray machine. Studying     samples of blood from patients who have undergone a stem cell transplant in the laboratory     may help doctors identify and learn more about biomarkers related to CAD. Using a CT scan in     combination with biomarker analysis may be a better and less-invasive way to diagnose CAD.   "
92357|NCT02077205|"     Manualised Cognitive Behavioral Therapy for children and adolescents with anxiety disorders     is evaluated in a routine care setting to evaluate the efficacy of the intervention. Children     and adolescents receive manualized Cognitive Behavioral Therapy for anxiety disorder.      It is expected, that the intervention will result in less anxiety / lower scores on the     primary and secondary outcome measures.   "
92358|NCT02077192|"     The purpose of this study is to determine whether fostamatinib is safe and effective in     treating patients with persistent/chronic Immune Thrombocytopenic Purpura (ITP) over a 2 year     period.   "
92404|NCT02076594|"     This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced     (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this     stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B).     Randomization will be stratified by performance status (ECOG 0, 1 and 2).   "
92359|NCT02077179|"     Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and     Action Plan state that women's heart health is a key national priority; it should be     addressed through improving heart health awareness and prevention, and reducing care     inequities for women in general and younger women in particular. The investigators have     developed an innovative and interactive mobile website based postpartum lifestyle     modification program (regular physical activity and nutritional guidance), based on     established national guidelines, to improve heart disease risk factors in women. The     investigators will conduct a trial to determine if the mobile website based lifestyle     modification program can be maintained and reduces a collection of risk factors, which     occurring together, greatly increases the risk of developing heart disease. The investigators     hypothesize that the interactive mobile website directing regular physical activity and     personalized nutritional guidance, compared to standard postpartum care, will be motivational     and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the     intervention group.   "
92360|NCT02077166|"     This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in     combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse     Large B-Cell Lymphoma (DLBCL) not eligible for transplant.   "
92379|NCT02076919|"     The purpose of this first-in-human study is to assess the local ocular and systemic safety     and tolerability of LHA510 eye drops when administered at various concentrations and dosing     frequencies.   "
92380|NCT02076906|"     The purpose of this study is to determine if Magnetic Resonance guided High Intensity Focused     Ultrasound ablative therapy is safe and feasible for children with refractory or relapsed     solid tumors.   "
92391|NCT02076763|"     This is an observational prospective study that will allow evaluating the clinical and     laboratory parameters evolution of at least eight patients with AIP.      This study will allow establishing a baseline for the evaluation of the eight patients that     are planned to be included in a gene therapy clinical trial (AAVPBGD-AIP-001) for the AIP     treatment using a rAAV5-AAT-cohPBGD expression.      Patients fulfilling the study inclusion criteria will undergo a clinical and laboratory     evaluation for a minimum of 6 months (with one inclusion visit, one final visit and at least     two visits of follow up) up to a maximum of 24 months until their inclusion in the subsequent     clinical trial.      A complete evaluation of the clinical (symptoms and quality of life assessment) and     laboratory (blood and urine) data will be collected.   "
92392|NCT02076750|"     The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is     effective in correcting low vitamin D levels in children and adolescents with inflammatory     bowel disease (also known as Crohn's disease and ulcerative colitis).   "
92361|NCT02077153|"     Reminiscence group therapy is a brief and structured intervention that has been shown to be     effective for improving well-being among older adults. Reminiscence helps accepting the     ageing process by solving unresolved issues and past losses; the group setting empowers the     efficacy of the process by giving back to elderly a way to manage their skills in a wider     setting and interact with other people. The sharing of memories reinforces the identity     through active tasks, preparing individuals to cope with the final part of the life. However,     considering reminiscence interventions for older populations, controlled trials adopting     better inclusion/exclusion criteria, standardized measures, and different conditions for     comparing the effect are needed.      According to this premise, the trial presents the design of a randomized controlled aimed at     comparing group reminiscence therapy with a group recreational activity in a older     population. It includes two groups of approximately 20 hospitalized elderly: (1) the     Experimental Group, (2) the Control Group. Participants included in the Experimental Group     will receive a group reminiscence therapy of six sessions, while the Control Group will     participate in a recreational group discussion. Between design with repeated measures will be     used to evaluate changes in self-reported outcome measures of depressive symptoms,     self-esteem, life satisfaction, quality of life across baseline, post-intervention and three     months post-intervention.      What the investigators would like to show with the present trial is the efficacy of a group     reminiscence intervention in a hospitalized population of older adults: focusing on specific     past events and re-living them in a group environment may enhance the self-esteem and quality     of life better than a simple group discussion.   "
92362|NCT02077140|"     The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and     women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to     determine the analgesic efficacy of MDT-10013 compared with standard of care in the treatment     of acute postoperative pain after subjects undergo bunionectomy.   "
92363|NCT02077127|"     The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood.     Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated     with diabetic microvascular or macrovascular complications. However, the relationship between     SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains controversial.     In the present study, we evaluated the association of a single nucleotide polymorphism (SNP)     in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular edema (DME) in Chinese     population from Southern China with type 2 diabetes.   "
92364|NCT02077114|"     The purpose of the study is to assess whether a vaccine containing a small fragment of the     protein IDO, which may be present in cancer cells and cells of the immune system, is safe to     use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant     melanoma that has metastasized.   "
92365|NCT02077101|"     The main objective of the study is to assess the acceptability of a future therapeutic     vaccine against HIV in patients living with HIV-1.      Secondary objectives concern the validation of a specific questionnaire for self-perception     and acceptability of therapeutic vaccination against HIV-1 (RAVVIH), the development of a     composite score for acceptability based on this questionnaire, and the analysis of critical     factors related to: representations of vaccination in general, representations of therapeutic     vaccination specific to HIV, perception of disease severity, health-related quality of life,     doctor-patient relationship.   "
92366|NCT02077088|"     Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to     decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of     allergy in family   "
92368|NCT02077062|"     Prospective non-randomized trial to study expression of mediators of post hepatectomy liver     regeneration (PHLR) and compare with a non-hepatectomy group: a pilot study Background :     Experimental studies using post hepatectomy animal models have been used to study the     mechanism of liver regeneration. Hepatectomy for various diseases and living donor liver     transplant provide a good human model to study in vivo mechanism of liver regeneration. These     studies are necessary for the clinical application of the knowledge obtained by animal     experiments and will guide further research to develop new modalities for the management of     hepatic failure, cirrhosis and cancer.      Null hypothesis: Expression of mediators of post hepatectomy liver regeneration (PHLR) is not     different between hepatectomy (study group) and non hepatectomy group (control group).      Aim: To study the mechanism of post hepatectomy liver regeneration(PHLR) and compare     expression of mediators of PHLR between hepatectomy (study group) and a non-hepatectomy group     (control group).      Patient and method: This prospective non randomized trail will be conducted on two group of     patients- hepatectomy (Study) group and non-hepatectomy (control) group and minimum 10     consecutive adult (18 year or more) patients will be recruited in each group according to     inclusion and exclusion criteria given below. Informed consent will be obtained from the     patients in both the groups. Peripheral (from a forearm vein) venous blood (6 ml) will be     collected a day before surgery and at different intervals after surgery (day 1, day 3,7, 2     weeks, 6 weeks and 6 months). A small branch of portal vein will be cannulated a 20 gauge     intravenous catheter for measurement of portal pressure and collection of portal venous blood     (6 ml) at the start (after entry inside the abdomen) and at the end (before closure of the     abdomen). Patients in hepatectomy (study) group will undergo trucut (needle) biopsy from the     remnant liver. Mediators of liver regeneration will be measured by standard methods in blood     samples from both groups. The liver tissue from study group will also be analysed for factors     related to initiation of PHLR.   "
92369|NCT02077049|"     The main objective of this study is to determine whether elderly people in rehabilitation     setting show higher adherence to self-training when using computer-based-learning games (i.e.     the so called serious games) than when performing conventional exercises. Secondly the study     explores to which extend balance and mobility performances vary according to the mode of     self-training.      The primary study hypothesis is that elderly people practice longer and more frequently with     serious games than with a conventional exercise booklet. The secondary hypothesis is that     patients experience a significant higher improvement in their balance capacity by using     serious games compared to patients performing conventional exercises.   "
92370|NCT02077036|"     The overall aim of the study is to investigate the effect of a new, non-pharmacological     method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the     use of medications with potentially serious side effects in patients with this disease.   "
92393|NCT02076737|"     The purpose of this study is to determine if Model-based iterative reconstruction (MB-IR     VEOTM) in ultra low-dose abdominal CT as the same accuracy for the diagnosis of acute renal     colic versus standard CT with adaptative statistical iterative reconstruction (ASIR).   "
92372|NCT02077010|"     Patients with end stage heart failure have significant symptoms (including fatigue and     shortness of breath) which prevent them from being able to perform most activities of daily     living. Milrinone is one of the inotropic medications that has been studied and used in the     treatment of end stage heart failure. End stage heart failure patients awaiting a heart     transplantation often have to be maintained on IV milrinone 24 hours a day through a chronic     IV line. Two problems arise with this therapy. First, the IV line itself creates an     opportunity for infection and blood clots, in addition to interfering with patient's quality     of life. Second, patients may be exposed to higher levels of milrinone when given IV than are     necessary for maintaining their heart's function.      The investigators goal is to show that inhaled milrinone is equivalent to standard of care     IV milrinone in improving heart and lung pressures in end stage heart failure patients (who     respond to milrinone therapy) in a prospective, randomized, controlled clinical trial.     Patients who are sent for a right heart catheterization procedure by their cardiologist to     determine if they require milrinone will be randomly chosen to be in the continuous IV     milrinone group or the inhaled milrinone group after agreeing to participate in this study.     Patients in the inhaled milrinone group will receive 60mg in 4ml of fluid inhaled by a jet     nebulizer every 8 hours. Patients in the IV arm will receive a constant IV infusion rate.     Both groups will have a standard-of-care repeat right heart catheterization procedure an     average of 48- 96 hours after milrinone initiation to evaluate their response to milrinone.     Afterward, all patients that respond will be placed on the standard of care IV milrinone for     the duration of their therapy, as directed by their cardiologist.   "
92373|NCT02076997|"     Pediatric cancer patients are being asked to take part in this study who have a cancer that     is treated with high doses of the drug methotrexate (MTX). In addition, these patients have     either had significant side effects to methotrexate in the past or their doctor thinks that     they are at high risk for side effects from receiving methotrexate. Methotrexate is a     cancer-fighting drug that is very important in the treatment of leukemia.      In this study, investigators are testing a new method of giving high dose methotrexate to     cancer patients which may reduce the chances that the level of methotrexate in the blood is     too high. When the levels are too high this is thought to lead to an increase in side     effects. Side effects are unintended and unwanted results of treatment.      The initial ordered amount of methotrexate and the period over which methotrexate is given     will not change from the current standard of care (meaning what is usually done by doctors,     and would likely be done if the patient was not on this study). This study is testing a new     method of monitoring and potentially adjusting the final amount of methotrexate that the     patient will end up receiving based on levels of methotrexate in the blood in the first 24     hours in order to try to prevent side effects in patients with a previous history of side     effects from methotrexate or who are at high risk for having side effects.      On this study the investigators will check methotrexate levels in the blood 2 hours after the     patient starts receiving the drug and the investigators will lower the dose of methotrexate     if needed. Investigators will do the same thing again 6-8 hours later.      Investigators will also collect an optional blood sample from the patient because the     investigators want to study how genetic (DNA) differences are involved in how the body     processes methotrexate.   "
92374|NCT02076984|"     Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies     and a recent meta-analysis have reported encouraging results and recurrence rates similar to     open repair. The choice of the mesh and fixation methods is of paramount importance during     laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for     laparoscopic approach represent the first choice in several studies, due to the biomechanical     properties and the optimal integration into the abdominal wall. No data with statistical     relevance exist on the choice of fixation methods.      Primary end point of the present Italian multicentric prospective randomized trial is to     evaluate the safety and effectiveness of two different tacks to fix the lightweight     polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic     spiral tacks (Protack™) vs absorbable U shaped tacks (Securestrap™)      Design of the Study: 200 patients with ventral hernia will be randomized into two groups:      Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack;     Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by Securestrap.      Blind randomization will be guaranteed by an on-line software with specific key access for     every surgical unit participating in the study. Patients demographics and characteristics,     preoperative studies, intraoperative and postoperative results and complications, as well as     scheduled follow-up will be recorded and uploaded to the database. Data represented by     continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data     will be expressed as geometric mean +/- 95% confidence interval. Data representing low     incidence events will be expressed as number and percentage of occurrence for each group.     Statistical significance for all analyses will be indicated by a p value of 0.05 or less.   "
92375|NCT02076971|"     The purpose of this study is to determine the sensitivity and specificity of QuantiFeron® and     ImmuKnow® in combination for early detection of patients who will develop CMV infection in     lung transplant patients with CMV-positive serology (R+) prior to transplant.   "
92376|NCT02076958|"     The aim of the proposed project is to identify an optimal implementation strategy using a set     of evidence-based interventions that aim to increase early detection of breast, prostate, and     colorectal cancer among African Americans as a model. These three interventions will be     packaged and interwoven into a single branded project, Project HEAL (Health through Early     Awareness and Learning) which will be delivered through trained Community Health Advisors     (CHA) in African-American church settings. The implementation and sustainability will be     evaluated using the RE-AIM Framework. Fourteen African American churches in Prince George's     County, MD will be randomized to a traditional classroom training approach or an online     training approach, in which the CHA training approach and level of technical assistance is     varied (in-person classroom training of CHAs + monitoring/evaluation + technical assistance     and training vs. online training of CHAs + monitoring and evaluation only, respectively). By     varying the training methodology and level of technical assistance, we will be able to     determine what level of technical assistance leads to successful implementation and     sustainability. We will also identify church organizational capacity characteristics that     lead to successful implementation and sustainability. The specific aims of this research are     to: (1) Package the three interventions into a single branded project (Project HEAL), develop     a local cancer screening resource guide, and pilot test the materials and training. (2)     Implement Project HEAL in 14 churches in Prince George's County, Maryland. We will evaluate     the implementation outcomes involving treatment fidelity and identify church organizational     capacity characteristics that led to successful implementation. We will compare the two     implementation strategies (traditional vs. online) to determine the optimal level of     technical assistance necessary for successful implementation. (3) Evaluate the sustainability     of Project HEAL over a two-year period of time. We will identify church organizational     capacity characteristics that led to sustainability, and compare the two implementation     strategies (traditional vs. online) to determine the optimal level of technical assistance     for successful sustainability.   "
92377|NCT02076945|"     Background Between 25 and 55% of diabetic patients develop neuropathy secondary to     hyperglycemia. High resolution bedside ultrasound has been demonstrated to be a useful tool     to detect the presence of neuropathy prior to block performance, by measuring the     cross-sectional area of the posterior tibial nerve: a value superior to 19.01 mm2 at a     distance of 3 cm above the medial malleolus has an optimal threshold value for identification     of diabetic sensorimotor polyneuropathy.      Animal data showed that duration of sciatic nerve block with local anesthetics is longer in     diabetic rats compared with non-diabetic rats. Characteristics of a peripheral nerve blockade     in humans with diabetic sensorimotor neuropathy are unknown.      Aim The aim of this study is to compare duration of analgesia and other characteristics of an     ultrasound-guided popliteal sciatic nerve block between diabetic patients with neuropathy,     diabetic patients without neuropathy and non-diabetic patients without neuropathy, based on     the ultrasound-measured cross-sectional area of the posterior tibial nerve.      Hypothesis We hypothesize that diabetic patients with neuropathy will have a duration of     analgesia lasting 50% longer than patients without neuropathy.      Methods This will be an observational study on diabetic and non-diabetic patients, with and     without peripheral neuropathy, based on the ultrasound-measured cross sectional area of the     posterior tibial nerve 3 cm above the medial malleolus (cut-off value, 19.01 mm2)      All patients will receive ultrasound-guided sciatic nerve block with 30 mL1:1 mixture of     lidocaine 1% and bupivacaine 0.5%, with the needle tip positioned at the bifurcation of the     sciatic nerve in peroneal and tibial nerve, below the common fascia or paraneurium. Block     success will be confirmed by loss of sensation to pinprick in the distribution of the common     peroneal and tibial nerves 30 minutes following local anesthetic injection. This procedure     will be completed by a saphenous nerve block. Postoperative pain management will be     standardized.      Pain and block-related endpoints will be collected such as onset time of action of sensory     and motor blockades, duration of analgesia, pain scores and opiates consumption among others.      Relevance Defining the duration of analgesia in case of diabetic neuropathy will help     regional anesthesiologists to better define the type and doses of drugs that will be injected     and to better prescribe the postoperative multimodal analgesic treatment.   "
92378|NCT02076932|"     The purpose of this study is to determine if physical exercise reduces the adverse changes in     adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal     transition.   "
92381|NCT02076893|"     Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over     530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The     postoperative period can be particularly painful. A recent clinical consensus acknowledges     there is no standard analgesic protocol, and calls for further research comparing     postoperative pain medications (Baugh et al., 2011). Tramadol was found to be as effective as     codeine with few reported side effects in a recent double-blinded, controlled trial conducted     by the investigators at Children's Hospitals and Clinics (CHC), and it is currently being     prescribed in the postoperative setting. However, despite its effectiveness for pain control,     there were some children that continued to report pain during the 10-day follow-up period. In     response, the investigators will conduct a randomized, double-blinded controlled trial to     determine whether or not adding scheduled gabapentin to a scheduled tramadol + as needed     (PRN) ibuprofen regimen provides better pain control than tramadol + ibuprofen PRN alone     during the post-tonsillectomy period. Using a 10-day take-home diary, caregivers will be     asked to record daily information about their child's postoperative pain and other core     outcomes and domains as recommended in the recent consensus statement put forth by the     Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials     (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the     efficacy and side effects associated with adding scheduled gabapentin to a postoperative pain     management protocol in a pediatric population.   "
92382|NCT02076880|"     Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the     gastric fundus. According to a recent randomized study, weight loss and resolution of     diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but     with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after     sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2     diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide     1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly.     The important caloric restriction in the early postoperative period indeed improves hepatic     insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of     this surgical procedure cannot be excluded.The aim of our study is to explore the early and     late metabolic effects of sleeve gastrectomy in severely obese patients with     non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin     secretion and incretin effect. We will include 14 obese patients with type 2 diabetes,     considered eligible to bariatric surgery according to HAS criteria, and whose diabetes     treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a     1-week caloric restriction period or no caloric restriction, immediately before surgery. Test     meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and     ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month     and 12 month after surgery.   "
92383|NCT02076867|"     The purpose of this study is to compare the effectiveness of Intensive Short-Term Dynamic     Psychotherapy (ISTDP) plus Medical Care As Usual (MCAU) compared to MCAU for Somatic Symptom     and Related Disorders (SSRD). Consenting patients presenting to the emergency department with     suspected SSRD will be randomly allocated to receive either 8 weekly individual sessions of     ISTDP or to an 8-week wait list followed by ISTDP. MCAU including emergency department and/or     family doctor consultation is available throughout trial participation. The primary outcome     measure is participant self-reported somatic symptoms at week 8.   "
92384|NCT02076854|"     The aim of this study is to pilot an innovative motivational text-message intervention for     individuals with anorexia nervosa and subthreshold anorexia nervosa. Patients will receive     personalized motivational text-messages as an adjunct to cognitive behavioral therapy (CBT).     CBT will be provided to patients at no cost for the duration of the study. The investigators     hypothesize that the text-messages will help increase motivation to change and kilocalorie     intake and decrease eating disordered behavior.   "
92387|NCT02076815|"     The purpose of this study is determine whether Anagrelide Retard is non-inferior to     anagrelide immediate release form in treatment of essential thrombocythemia.      Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterised by a sustained     increase in platelet counts above the normal value (> 450 x 109/L) and increased     megakaryopoiesis in the bone marrow, without secondary causes of thrombocytosis.      Anagrelide hydrochloride selectively reduces platelet numbers by inhibiting megakaryocyte     development and maturation in humans, without affecting other cell lineages.      Anagrelide Retard is a new, prolonged release (PR) tablet formulation of anagrelide developed     by AOP Orphan Pharmaceuticals AG. The rationale for developing this new formulation is based     on the assumption of having a better tolerability while maintaining an efficacy comparable to     that of the immediate release formulation.      The effects of Anagrelide Retard and Thromboreductin® will be compared in terms of mean     platelet count measured by a central laboratory/centralized method at 3 time points during     the maintenance phase.   "
92388|NCT02076802|"     The epidemic data shows that prehypertension is associated with cardiovascular disease, and     heavy dietary salt intake could improve the developing of hypertension. We detected the risk     factors of coronary atherosclerosis of prehypertensive patients with different levels of salt     intake.      The aim of this multicenter prospective, randomized controlled study is to evaluate regular     physical exercise and salt diet effects on progression of coronary artery disease in patients     with prehypertension.   "
92408|NCT02076542|"     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly     developed treatment and education module will be tested compared to a waiting-list control     group. The module covers the topic diabetes and sports. Primary outcome variable is     diabetes-specific empowerment regarding diabetes and sports. Secondary outcome variables are:     diabetes-related distress, health-related quality of life, depressive symptoms, self-care     behavior, and glycemic control.   "
92394|NCT02076724|"     The purpose of this study is to compare two methods for reinforcement of the abdominal     donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the     abdominal donor-site is performed, after randomization, with either a porcine derived     biological mesh or a synthetic mesh. The patient and the investigator is blinded.      The aim is to identify the most optimal method for reinforcement of the abdominal donor-site     and thereby contribute to fast and complete rehabilitation of women undergoing breast     reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to     breast cancer, precursors to breast cancer or an increased risk of developing breast cancer     and thereby following preventive removal of the breast tissue.      The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal     wall function, the donor site morbidity, the frequency of postoperative complications, the     aesthetic appearance of the reconstructed breast and the abdominal wall and costs are     evaluated.   "
92395|NCT02076711|"     Background - Aortic valve stenosis (AS) is the most common heart valve disease among adults     in the Western world with a prevalence of 3 % in people older than 75 years of age. AS     usually deteriorates over time leading to heart failure, with high mortality if aortic valve     replacement (AVR) is not performed. Thus optimal timing of AVR is crucial, but can be     challenging. Increasing life expectancy in our society will augment the therapeutic and socio     economic impact of AS disease on our health care system. Therefore, new techniques for     monitoring asymptomatic AS patients are needed. A potential approach is monitoring of LV     myocardial efficiency (mechanical work/oxygen consumption). These measures have been     suggested to be involved in the progression of non-valvular heart failure and closely related     to prognosis, but never applied in a larger population of patients with AS. At present there     are no recognized pharmacological treatments of AS. It is known that beta-blocker treatment     in non-valvular systolic heart failure reduce heart rate, improves LV myocardial efficiency     and reduces mortality. However, in patients with AS, the effects of beta-blockers are     unknown.      Hypotheses - Treatment with the beta-blocker metoprolol succinate in patients with     asymptomatic moderate to severe AS has beneficial effects on LV myocardial oxidative     metabolism, myocardial efficiency and contractile function.      Objectives - To investigate if beta-blocker treatment in patients with moderate to severe,     asymptomatic AS has beneficial effects on LV myocardial efficiency, contractile function and     physical performance.      Design - A randomized double blind placebo controlled intervention trial. 40 patients with     asymptomatic AS will be randomized to either per oral metoprolol succinate (N = 20) or     placebo (N= 20) for 22 weeks.      Primary objective - Changes in myocardial efficiency      Secondary objectives - Myocardial oxygen consumption, Myocardial perfusion at rest, LV     myocardial function, LVmass, Aortic valve area and transaortic valve velocities, 6 minute     walking distance, N-terminal prohormone of brain natriuretic peptide, Quality of life     (estimated by Minnesota living with heart failure questionnaire), LV wall stress      Methods - Patients will undergo echocardiography (resting and exercise), [11C]acetate PET and     cardiac magnetic resonance imaging.   "
92396|NCT02076698|"     The main objective of the study is twofold:        1. Assess the clinical efficacy of DBS on epilepsy according to their number and severity          at 1 year follow up.        2. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.      The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the     thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe     crises) of the most severe seizures, in at least 50% of patients who have drug-resistant     partial epilepsy; and should also improve significantly the quality of life through a gain of     independence in activities of daily life, the possible recovery of functional abilities,     recovery of social or professional activities.   "
92397|NCT02076685|"     To improve the treatment outcome in patients with tuberculosis and integrate the     pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in     re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis     medication-induced hepatitis.   "
92398|NCT02076672|"     This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using     a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate     (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex     extract from the artichoke plant as a chemoprevention agent.   "
92399|NCT02076659|"     Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of     F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.   "
92400|NCT02076646|"     A prospective, open-label, multi-center, Phase I/II study of L19IL2 in combination with     Dacarbazine in patients with metastatic melanoma.   "
92401|NCT02076633|"     This Phase II study is an uncontrolled, multicenter, prospective study for patients with     malignant melanoma of the skin in clinical stage III or stage IV M1a.      Twenty Patients will be treated with a mixture of L19IL2 and L19TNF once weekly for up to 4     weeks.      The dose will be distributed among the lesions via multiple intralesional injections.      The proportion of patients with complete response at week 12 will be calculated.   "
92402|NCT02076620|"     Prospective, open-label, non randomized, dose escalation study that will be conducted in     sequential cohorts of patients.   "
92406|NCT02076568|"     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly     developed treatment and education module will be tested compared to a waiting-list control     group. The module covers the topic diabetes and partnership. Primary outcome variable is     diabetes-specific empowerment regarding diabetes and partnership. Secondary outcome variables     are: diabetes-related distress, health-related quality of life, depressive symptoms,     self-care behavior, and glycemic control.   "
92407|NCT02076555|"     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly     developed treatment and education module will be tested compared to a waiting-list control     group. The module covers the topic diabetes and social issues. Primary outcome variable is     diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome     variables are: diabetes-related distress, health-related quality of life, depressive     symptoms, self-care behavior, and glycemic control.   "
92410|NCT02076516|"     The purpose of this study is to evaluate the safety and effectiveness of the CORACTO®     (Rapamycin®-Eluting coronary stent delivery system) for the treatment of up to two de novo     lesions or restenotic post-PTCA (non-stented) lesions located in up to two epicardial native     coronary arteries (maximum one lesion per vessel) suitable for treatment with stents from 2.5     to 4.0 mm in diameter < than 15 mm suitable for treatment with a single CORACTO® stent in a     population of 100 patients.   "
92411|NCT02076503|"     Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate     staging of the disease at the time point of diagnosis is important. The objective of this     study is to evaluate the diagnostic potential of a combined PET/MR examination for risk     assessment and detection of lymph node metastases. The overall aim of the project is to     improve the investigators ability to provide individually tailored treatment to prostate     cancer patients.      The study will include 32 men with high-risk prostate cancer, who are eligible for radical     prostatectomy. Informed consent is a requirement for inclusion in the study.   "
92412|NCT02076490|"     The overall aim of this randomized controlled study is to investigate the effectiveness of     mirror therapy supported by telerehabilitation on the intensity, duration and frequency of     phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor     exercises without a mirror in patients following lower limb amputation.   "
92413|NCT02076477|"     This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage     iv lung cancer.   "
92414|NCT02076464|"     The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce     eating disorder outcomes in college-age women.   "
92415|NCT02076451|"     This will be a Phase 1, open-label study of DS-8273a to assess its safety and tolerability,     identify the Maximum Tolerated Dose and/or Maximum Administered Dose, and assess its     properties in subjects with advanced solid tumors or lymphomas.      Up to 5 US sites are planned for participation in Part 1 (Dose Escalation) and Part 2 (Dose     Expansion) in subjects with solid tumors or lymphomas.   "
92416|NCT02076438|"     The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus     GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics     as well as Clostridium difficile Diarrhea.   "
92417|NCT02076425|"     Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a     sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL)     control after which participants will receive the active treatment. PCIT-ED is an expansion     of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive     disorders. To address early disturbances of mood and affect, a novel ED module was added     based on empirical data in emotion development. The ED module targets parent emotion learning     skills with the goal of training the parent to serve as a more effective emotion teacher and     coach to the child. The goal of the ED module is to enhance the child's capacity for emotion     recognition and regulation or emotional competence. In order to test the efficacy of     PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of     treatment response participants will complete comprehensive pre-, interval, and     post-assessments.      Preschoolers over 3 will be offered the option of enrolling in an add-on     electroencephalography and magnetic resonance imagery study, to investigate neural changes     associated with PCIT-ED.      Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show     significantly increased rates of remission, greater reductions in MDD symptoms, and decreases     in impairment; and will show significantly greater increases in emotional competence measured     by the ability to accurately identify emotions in themselves and others and the ability to     effectively regulate intense emotions. Compared to those on the WL, parents who undergo     PCIT-ED will show significantly greater increases in emotion skill learning and reductions in     MDD symptoms and parenting stress.   "
92418|NCT02076412|"     The purpose of this study is to determine whether fostamatinib is safe and effective in the     treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).   "
92419|NCT02076399|"     The purpose of this study is to determine whether fostamatinib is safe and effective in the     treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).   "
92420|NCT02076386|"     DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir     as part of an antiretroviral combination therapy in routine daily practice in Germany. The     primary study objective is a descriptive characterization of the frequency of therapeutic     monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine     daily practice in Germany.      The study is designed to enroll approximately 400 patients. There are no protocol-mandated     visits or procedures associated with the study. Each patient is expected to participate for a     maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir,     due to death, withdrawal of consent, lost to follow-up).   "
92421|NCT02076373|"     The purpose of this randomized and placebo-controlled EpoRepair trial is to evaluate the     effect of intravenously administered recombinant human erythropoietin (Epo) as compared to     placebo in preterm infants with brain damage on neurological development until five years od     age.   "
92464|NCT02075801|"     -  Assess the effectiveness of sealing localized marginal defects of amalgam restorations          that were initially scheduled for replacement of restorations.        -  The hypothesis was that sealed defective margins of the amalgam restorations shows          similar performance than replacement amalgam restorations.   "
92422|NCT02076360|"     This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical     trial at one institution evaluating the use of a preoperative patient education video as an     adjunct to preoperative counseling on patient-centered outcomes.      The aim of this study is to determine the impact of a preoperative patient educational video     as an adjunct to the routine preoperative visit on patients' preparedness for surgery,     perception of time spent with their healthcare team, and ultimately their satisfaction after     surgery. The aim of this video is not to limit the doctor patient interaction (as all     patients will still be granted their pre-allotted 30 minute visit with the physician     regardless of their intervention allocation) but rather to augment the visit with additional     educational information in an attempt to optimize the visit.      Objective:      A. Primary Aim(s):      • To determine if patients feel more prepared for surgery with addition of preoperative     patient education video      B. Secondary Aim(s):        -  To determine if addition of preoperative patient education video correlates with          improved patient satisfaction after surgery        -  To determine if patients' perception of time spent with healthcare team in preparation          for surgery increases with addition of patient educational video        -  To determine if actual patient-physician time spent counseling differs between groups        -  To determine if patient preparedness is correlated with objective surgical outcomes        -  To determine if patient preparedness is correlated with patient symptom improvement          scores after surgery      Hypothesis:      The addition of a preoperative patient education video enhances patient preparedness for     surgery, increases perception of the amount of time patients spend with healthcare team, and     improves patient satisfaction.   "
92423|NCT02076347|"     The purpose of this project is to compare two pharmacist-led population management strategies     designed to increase the rate of appropriate monitoring of vitamin B12 and serum creatinine     for patients taking metformin.   "
92424|NCT02076334|"     To examine the influence of compression garments manufactured with Far-Infrared technology on     exercise performance during and after repeated eccentric isokinetic muscle actions of the leg     extensors.   "
92425|NCT02076321|"     Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications     for providing pain control in children with fractures or those who have surgery to correct     bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to     suggest that these types of medications can adversely affect bone healing in adult patients     with broken bones or those having spine fusion surgery. There is little data with regard to     how these medications effect bone healing in children. With this project, the investigators'     goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to     demonstrate that these medications adequately control pain in children with broken bones or     those who have had an osteotomy.   "
92426|NCT02076308|"     Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly     seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively     prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and     disability. These patients need early and regular rehabilitation to regain their function and     prevent unnecessary complications such as contracture and disuse atrophy. Proper     rehabilitation is important but the challenge is also great. However, rehabilitation training     is a very labor-intensive task in which one to one treatment is essential and that will     restrict the number of patients served. Moreover, patients receiving home programs are     difficult to supervise, resulting in reduced training effect and delayed functional recovery.     In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of     rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of     upper-limb exoskeleton rehabilitation robot and its related technology and human-robot     interaction. This robot is used to serve the rehabilitation need of those patients suffering     from upper extremities dysfunctions and also can provide careful designed therapeutic program     of upper limbs including shoulder and elbow joint exercises. Its control software also     provides a therapeutic management system with intelligence and ergonomic consideration. This     work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for     both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The     clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and     finally approved by Department of Health (DOH) in April 2011. This team had completed the     clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon     this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen     Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.   "
92427|NCT02076295|"     Mild cognitive impairment and dementia are frequent non-motor complications of moderate to     advanced Parkinson's disease. Brain positron emission tomography (PET) study findings confirm     post-mortem evidence that cholinergic loss is related to cognitive impairment in Parkinson's     disease. However, current cholinergic augmentation therapy is not always effective and it     should only target those Parkinson's disease patients who have evidence of cholinergic system     impairment. The objective of this study is to study the association of a particular subtype     of cholinergic receptors, so-called nicotinic acetylcholine receptors, with cognition in     Parkinson's disease using a novel PET marker of cholinergic system integrity.   "
92428|NCT02076282|"     Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In     order to irradiate as precise as possible, and in order to evaluate the effect of radiation     treatment, it is important to depict the lung tumor and the lymph node metastases as accurate     as possible. Currently, radiation oncologists use PET-CT for this purpose. However, PET-CT     does have its drawbacks, and partly because of this, large volumes are irradiated in current     treatment.      The investigators believe that MRI can be used to improve depiction of the tumor and lymph     nodes and of their motion. However, there is currently no MRI protocol available which is     aimed at improving radiotherapy.      In this study, the investigators want to select the optimal MRI settings for depiction of the     lung tumor, the lymph node metastases and their movement.      The investigators plan to do this by first examining 10 healthy volunteers, followed by 20     patients with non-small cell lung cancer.   "
92429|NCT02076269|"     This purpose of this study is to obtain inhalation profiles in subjects with very severe     Chronic Obstructive Pulmonary Disease (COPD). This is a study with no investigational     medicinal product. Each subject will attend the clinic on 2 occasions, initially for a     screening visit and then for further assessments if included (Visit 1). The maximum time that     a subject may be enrolled in the study is 33 days from the screening visit to follow up.   "
92430|NCT02076256|"     Helping relationships from significant others may assist patients with chronic kidney     diseases to exercise health behaviors. Patients will adhere on the suggestions from medical     staff and perform health lifestyle to maintain healthy behavior. The progress of the disease     may be delayed.      The research is a 3-year study to explore the influence of helping relationships on healthy     behaviors among patients with chronic kidney disease. Building on the findings from the past     three years study and the literature on trans-theoretical Model, helping relationships will     be articulated. A helping relation intervention will be applied to evaluate its effect on     healthy lifestyle and quality of life.      The first year study will be a survey design. An instrument to measure the helping     relationship will be established and tested. Total of 200 participants will be recruited to     test the reliability and validity of the instrument. After evaluating the psychometric     properties of the instrument, items may be revised according to the results. The second year     of research will be a cross-section study. Of 250 subjects will be recruited to explore the     correlations between helping relationships, healthy life styles, and quality of life. Data     will be analyzed using hierarchical linear regression. In the third year, an experimental     design will be applied to test the effect of a helping relationship intervention. One hundred     and twenty subjects will be recruited and randomly assigned to the experimental and the     control group for 60 subjects in each group. The helping relationships intervention program     will be implemented on the experimental group. And the control group will be provided with     routine nursing care. Data will be collected at baseline, the sixth and the ninth month of     the third year of study. Data will be analyzed using generalized estimating equation measures     to evaluate the effect of the intervention program.   "
92465|NCT02075788|"     The purpose of this study is to investigate how millet incorporation into different baked     product types influences glycemic response and satiety.   "
92431|NCT02076243|"     This is an investigator initiated phase II study to assess the efficacy of a chemotherapy     called nab-paclitaxel as first line cytotoxic chemotherapy in subjects with unresectable     locally advanced or metastatic cutaneous squamous cell carcinoma (SCC). All subjects receive     the treatment by vein weekly and receive the same dose of the treatment.      The risk of developing cutaneous SCC is approximately 10% in a lifetime. The vast majority     are treated surgically and do not recur. However a small percentage become unresectable over     time or metastasize distantly in the body. Unresectable and metastatic cutaneous SCC has a     poor prognosis and oncologists often choose a whole body therapy without the benefit of     prospective efficacy data. Very little prospective investigation into the efficacy of     specific chemotherapy regimens as a function of line of therapy has been performed in this     patient population. Nab-paclitaxel is type of chemotherapy that has demonstrated activity in     other types of cancer such as lung and head and neck cancers. The primary objective of this     study is to determine the response rate (percentage of subjects with tumor shrinkage) to     nab-paclitaxel treatment in subjects with cutaneous SCC who have not received cytotoxic     chemotherapy in the unresectable or the metastatic settings.. Secondary objectives are the     progression free survival (time until tumor starts to grow), safety, assessment of the     percentage of subjects whose tumor expresses a protein called SPARC, and correlating the     expression of SPARC with response to treatment. To determine if the tumor expresses SPARC     part of a prior standard biopsy such as that performed to establish the diagnosis of SCC will     be used. SPARC is a protein that is overexpressed in a range of different cancer types and     may alter the environment around the tumor possibly in a way that may make the SCC more     responsive to treatment with nab-paclitaxel.   "
92432|NCT02076230|"     This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite     profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent     treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid     tumors.   "
92435|NCT02076191|"     The purpose of this study is to test the safety and tolerability of ruxolitinib at different     dose levels in combination with decitabine and the effectiveness of ruxolitinib in     combination with decitabine in patients with accelerated or blast phase Myeloproliferative     Neoplasm (MPN), which is a group of diseases of the bone marrow in which excess cells are     produced. Ruxolitinib is a drug that is approved by the Federal Drug Administration (FDA) for     the treatment of patients with advanced forms of myelofibrosis. It inhibits the Jak proteins     that are often abnormal in MPN. A recent clinical study showed that ruxolitinib treatment     could put some patients with this disease into remission. Decitabine is a chemotherapy,     approved by the Federal Drug Administration (FDA), that has been used to treat acute     leukemia. It works in some patients, but most patients with accelerated and blastic MPN do     not respond to treatment. Ruxolitinib and decitabine will be combined in this study to find     out what dose of the two medicines are safe together. Using Ruxolitinib in combination with     Decitabine is experimental. The investigators want to find out what effects, good and/or bad     it has on the patient and the disease.   "
92436|NCT02076178|"     This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate     the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation     (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable     agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week     intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized in     a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral 744     (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study, followed     by a one week washout period. Following safety lab assessments from the Oral Phase,     participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744     LA or placebo at three time points at 12 week intervals. IM injections will consist of 800 mg     of 744 or a matching control   "
92437|NCT02076165|"     Women Veterans have high rates of insomnia. Prior research and our preliminary findings show     that insomnia impacts the health and quality of life of women Veterans and that those with     insomnia prefer non-medication treatments over sleeping pills. The proposed study will     compare two non-medication behavioral treatments for insomnia to determine impacts on     adherence rates and sleep/wake patterns. The results of this study will ultimately improve     the repertoire of available behavioral treatments for insomnia within VA and improve     important health and quality of life outcomes among women Veterans who receive VA healthcare.   "
92438|NCT02076152|"     In this research study, the investigators are using FMISO-PET and MRI scans to explore the     delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before     and after treatment.      Bevacizumab is approved by the U.S. Food and Drug Administration for use in patients with     recurrent glioblastoma . It works by targeting a specific protein called VEGF, which plays a     role in promoting the growth or spreading of tumor blood vessels. Since anti-VEGF agents also     affect normal blood vessels in the brain, they can inhibit the way other drugs used in     combination with bevacizumab are delivered to the tumor.      In PET scans, a radioactive substance is injected into the body. The scanning machine finds     the radioactive substance, which tends to go to cancer cells. For the PET scans in this     research study, the investigators are using an investigational radioactive substance called     FMISO. Investigational means that the role of FMISO-PET scans is still being studied and     that research doctors are trying to find out more about it. FMISO goes to areas with low     oxygenation so parts of the tumor that do not have enough oxygen can be seen.      In addition, a vascular MRI will be used to evaluate the changes in tumor blood flow, blood     volume, and how receptive blood vessels are. This scan will be performed at the same time of     the FMISO-PET scan.   "
92439|NCT02076139|"     This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers     with or without tuberculosis infection. This trial aims to study the effect of the probiotic     Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week     after the first administration and the global tolerability of the treatment. Nyaditum resae®     is a preparation in the form of drinkable vials containing heat-killed environmental     mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on     immunity, which could reduce the risk of developing active tuberculosis.   "
92440|NCT02076126|"     The overall objective is to identify quickly after birth the preterm infants who will develop     respiratory distress syndrome (RDS) for the purpose of treating them as early as possible     with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen     treatment.      We have therefore developed a quick test, which we believe will be ideal for this type of     diagnostics, and will now test the method in a preclinical trial.   "
92622|NCT02073747|"     Empirical data from physician observation indicates an increase in serum lactate in acute     asthmatic patients being treated with inhaled albuterol therapy.      It is not clear if this increased serum lactate is in response to a physiological response to     the asthmatic process or from the albuterol treatment.      This study is designed to determine if administration of inhaled albuterol increases serum     lactate in healthy subjects.   "
92441|NCT02076113|"     The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal)     for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established     guidelines for the management of patients with CSM, which represents the most common cause of     spinal cord injury and dysfunction in the US and in the world.      This study aims to test the hypothesis that ventral surgery is associated with superior Short     Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal     approaches and that both ventral and dorsal surgery improve symptoms of spinal cord     dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A     secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion,     and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance     post-operatively is a significant predictor of SF-36 PCS outcome.   "
92442|NCT02076100|"     This is a 3-part study of ruzasvir (MK-8408) for participants with hepatitis C infection.     Successive participants will be enrolled as dose levels are evaluated to find the maximum     safe and well tolerated dose of ruzasvir. Part I will be for participants with hepatitis C     virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV     genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts     II and III may run concurrently. The primary study hypothesis is that a safe and tolerable     dose of ruzasvir that reduces viral load will be found to support further clinical     investigation.   "
92443|NCT02076087|"     The overall goal of this proposal is to characterize the immune cell profile of subcutaneous     abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate     potential associations between different adipose tissue immune cell types and metabolic     profile.   "
92444|NCT02076074|"     This phase I/II clinical trial studies the side effects of delivering radiation therapy in a     single session instead of multiple treatments over several weeks and to see how well it works     in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a     type of radiation therapy focused only to the part of the breast that has cancer in it, given     at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient     partial-breast irradiation may cause fewer side effects, help prevent breast cancer from     coming back, and improve the appearance of the breast and quality of life of patients with     breast cancer.   "
92445|NCT02076061|"     This is a longitudinal observational study to identify and validate protein biomarkers for     COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and     ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different     phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore,     linkage between COPD, cardiovascular disease, and lung cancer will be investigated by     identifying protein biomarkers.   "
92446|NCT02076048|"     The purpose of this study is to take images of the brain in order to see if long-chain     polyunsaturated fatty acid (LCPUFA) exposure during infancy influences brain structure and     function in middle childhood.   "
92447|NCT02076035|"     It is still unknown the pathogenesis of low back pain and a lot of hypothesis were discussed     for a long time. Because non-invasive imaging modalities greatly underestimate the prevalence     of epidural pathogenesis an endoscopic examination of the epidural space has been advocated     as both a diagnostic and therapeutic modality. It seems that immune-inflammatory factors play     a more substantial role in pain status. Myeloscopic investigation have shown how     morphological pictures of the epidural area in patients with chronic low back pain (CLBP) are     much more complex and heterogeneous than what can be identified with traditional     investigation suggesting a biochemical involvement. Endoscopy of the epidural space     (epiduroscopy) is a minimally invasive technique, used to directly visualize pathological     features inside of the lumbar spinal canal to locate tissues responsible of eliciting pain     and the presence of any pathological structures within the vertebral channel, such as fibrous     adherences, inflammatory processes, severe fibrosis and/or stenoses, in order to realize an     effective therapeutic approach in a lot of different CLBP status as those due to spinal     stenoses or failed back surgery syndrome. To deepen the molecular causes of interindividual     variability of epiduroscopy outcomes in terms of decrease of pain, it is useful to analyze     the DNA variants encoding IL6 and IL1 cytokines and to relate them with gene expression     levels and with the cytokine dosage. By this technique, it is possible to analyze in the     biopsy of the epidural tissue the specific expression of the cytokines: there is already     evidence that inflammatory factors may be involved in the genesis of LBP. At this regards, it     would be really important to compare systemic cytokine levels before the epiduroscopy with     those detected immediately post procedure and after one month, to understand if the cytokines     could play a key role and be a biomarker of the epiduroscopy outcome.      Concerning DNA polymorphisms, it has been demonstrated, in many disease-state meta-analyses,     that the IL6 variant rs1800795 affect gene transcription and influences the IL-6 levels.     Moreover, interleukin 1 (IL-1) is a major factor controlling the inflammatory response. The     IL-1 gene family includes the IL-1α, IL-1β and the IL-1 receptor antagonist (IL-1Ra) genes     that mediate immune and inflammatory responses. SNPs in IL-1α, IL-1β and IL1Ra modify bone     mineral density promoting intervertebral disc disease (IDD). The simultaneous carriage of the     IL-1bT3954 and the IL-1Ra A1812 alleles significantly enhances the risk of low back pain     (LBP) occurrence, the number of days with pain, and the number of days with limitations in     daily activities due to pain.      A recent study suggested that methylation status of a single CpG site in the IL6 promoter is     related to IL6 messenger RNA levels and that lower methylation contributes to the risk of     developing Rheumatoid Arthritis.      The investigators will try to identify if it there is a correlation with success of the     epiduroscopy approach in terms of freedom from pain with genic expression and cytokine     dosage.      Finally, the investifators will compare the cytokine gene expression and the DNA methylation     status of IL6 promoter in patients with favorable outcome and in no responders, to study the     role in gene expression.      This study is addressed to detect if the genetic variability might be used in near future in     clinical setting, to predict the success of epiduroscopy.   "
92448|NCT02076022|"     We propose a prospective, randomized clinical study to assess the efficacy of minimally     invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation sites.   "
92449|NCT02076009|"     The purpose of this study is to compare the effectiveness of daratumumab when combined with     lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms     of progression-free survival in participants with relapsed or refractory multiple myeloma.   "
92450|NCT02075996|"     The purpose of this non-interventional study is to collect data on the efficiency and safety     of pomalidomide in combination with dexamethasone in the routine application   "
92451|NCT02075983|"     Our research is part of the global effort to develop a vaccine against HIV. We aim to develop     a non-invasive, needle-free 'transcutaneous' vaccine. It will be a water-based solution which     is placed on the surface of the skin of the upper arm, after the hairs have been stripped     away. The active component of the vaccine - DNA which contains genes derived from the virus -     will enter through the hair follicles from which the hair has been stripped. The DNA will get     into cells, which will use the HIV genes to make copies of virus proteins. These proteins     will stimulate the body's immune system and, we hope, make it able to protect against HIV     infection. The research is to assess the safety of this approach, and how good it is at     stimulating the immune system. We will combine the 'transcutaneous' vaccine with an     'intramuscular' version which is injected into the muscle of the thigh, and compare this     combination with: intramuscular plus 'intradermal' (injection into the skin); and     intramuscular with added 'electroporation' - use of a pulse of electricity to increase uptake     of DNA vaccines.      We will invite healthy men and women to take part in this research. Volunteers will first be     assessed to ensure they are eligible to participate. A total of 30 will be enrolled and each     will receive three vaccinations over the course of 12 weeks. We will assess the effects of     the vaccinations by recording any symptoms experienced by the volunteers, and by analysing     samples of their blood. The research will take place at the St Mary's Hospital campus of     Imperial College London, UK. The DNA component of the vaccine is an experimental substance,     so we will monitor very closely the wellbeing of the men and women who participate in the     research.   "
92452|NCT02075970|"     Neonatal anemia is the most commonly encountered hematologic problem among all neonates cared     for in the neonatal intensive care unit (NICU). This project seeks to better understand the     pathophysiology and treatment of this challenging and important condition, especially as it     affects premature, critically ill very low birth weight (VLBW) infants who require intensive     laboratory blood monitoring leading to the need for multiple red blood cell (RBC)     transfusions (RBCTX). In the research strategy proposed in Study 1, Aims 1, 2 and 3,     recombinant human erythropoietin (Epoetin Alpha, PROCRIT, provided by Janssen Scientific     Affairs) will first be administered to 1.0 to 1.5 kg VLBW infants; then comprehensive     pharmacokinetics (PK) and pharmacodynamics (PD) data will be systematically gathered and     analyzed to identify clinical and laboratory covariate parameters differentiating the infants     based on their level of Epoetin Alpha responsiveness. Finally the Epoetin Alpha     responsiveness predictors thus determined will be applied prospectively in the Aim 4 Study, a     2 x 2 design in which VLBW infants will be identified as good or poor Epoetin Alpha     responders, based on the predictors, and then randomly assigned to receive Epoetin Alpha     treatment or no treatment. This will test the central hypothesis: RBCTX can be eliminated in     the majority of good Epoetin Alpha responders by optimal administration of Epoetin Alpha, but     only marginal reductions in RBCTx will occur in the poor Epoetin Alpha responders. This     project challenges the prevailing thinking that the efficacy of Epoetin Alpha dosing in     stimulating erythropoiesis is insufficient to eliminate the need for RBC transfusions in VLBW     infants. Based on extensive preclinical and clinical PK/PD studies by our PPG team, we     contend that previous Erythropoietin treatment studies in VLBW infants were not able to     realize the full potential of Erythropoietin to eliminate RBCTX (in contrast to the very     successful use of Erythropoietin in adult renal failure patients) because previous VLBW     studies were conducted 1) without Epoetin Alpha dosing individualized for the complexities of     neonatal erythropoiesis and PK/PD of Epoetin Alpha and 2) without consistent criteria for RBC     transfusion, Epoetin Alpha dosing, and patient enrollment. Net Epoetin Alpha responsiveness     as reflected in Hb level depends on two components: Epoetin Alpha PD and RBC lifespan (Fig     15). By determining RBC lifespan, we will explain inter-subject variability of Epoetin Alpha     responsiveness resulting from one of these components. The fetal lifespan data will be     examined for its correlation with gestational age. If the correlation is statistically     significant, gestational age will be included in the final selection of covariates for the     population PK/PD model to be developed at the end of Infant Study 1. To fully understand the     correlation of RBC lifespan with gestational age infants ranging from 22-42 weeks gestational     age will be studied. The overall impact of Project 1 will be significant and potentially     transformative: the development of a personalized, mechanism-driven approach built on sound     principles will improve understanding of neonatal anemia and will be applicable to the care     of premature, anemic infants.      RELEVANCE Project 1 results confirming our hypothesis that PK/PD optimized Epo treatment is     effective in eliminating RBC transfusions administered to a select sub-group of NICU infants     will provide fundamental knowledge about neonatal anemia that will reduce the burden of     illness and disability caused by this condition. In addition, our results will stimulate     researchers to extend our findings to other sub-groups with neonatal anemia, ie, smaller and     sicker infants, and will stimulate novel treatments with similar, new biotechnology-produced     protein drugs.   "
92453|NCT02075957|"     Description of new transcriptional profiles associated with risk of relapse and     identification of specific sites of relapse in non-small cell lung cancer, toxicity and     resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer     (NSCLC).   "
92454|NCT02075944|"     The present study will investigate the effects of aerobic exercise on cognition and growth     factors including brain-derived neurotrophic factor (BDNF) in young adults aged 15-21 years.     The included subjects will be randomized to three different groups including one control     group and two exercise groups. Subjects randomized to the exercise groups will complete 30     minutes of aerobic exercise 3 times a week for 9 weeks incorporating low (group I) or high     (group II) intensity aerobic exercise. The exercise will be conducted as running or indoor     cycling (supervised). At baseline and 9-weeks follow-up all subjects will complete two     cognitive tests (measures of concentration and sustained attention), a maximal cycling test     (direct measures of VO2max), an intelligence quotient test, anthropometric measures, fasting     blood samples and blood samples immediately following the cycling test. The blood samples     will be analyzed for growth factors including BDNF and metabolic factors.   "
92455|NCT02075931|"     The investigators have learned that knee replacement patients are not more physically active     after surgery. This is true even though their pain is less compared to before surgery. This     low level of physical activity is not healthy. It can increase the chances of weight gain,     which can create other issues. It can also lessen physical function. Some studies have looked     at physical activity feedback systems to increase how active people are. Studies have     investigated face to face patient group meetings for this,too. These systems and meetings can     increase physical activity. The investigators will study the effects of a physical activity     monitors with group meetings after knee replacement. The investigators hypothesize that     physical activity levels and physical function will increase. The investigators goal is to     help knee replacement patients lead healthier lives and maintain or enhance their physical     function.   "
92456|NCT02075918|"     Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis     Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis     Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be     enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool     will be collected to discover and validate factors associated with diagnosis, severity of     disease and survival.   "
92457|NCT02075905|"     Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab     for analysis of a validated biomarker panel. Subjects will be stratified to either high or     low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results.     Biomarker panel results will not be communicated to sites. Subjects with low grade dysplasia     will be offered the option of treatment (radiofrequency ablation (RFA)) as part of routine     care. Subjects with low grade dysplasia who do not want RFA and subjects with no dysplasia     will receive surveillance endoscopy in 1 year per routine care. All subjects will be     administered a questionnaire seeking information about hypothetical willingness to be     randomized to treatment or surveillance.   "
92458|NCT02075892|"     Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics,     aerobic power and time to fatigue in healthy adults.   "
92459|NCT02075879|"     The purpose of this study is to examine the effects of a nurse-led case management programme     on home exercise training for haemodialysis patients. We hypothesised that: a. There is no     significant difference in physical functioning between participants receiving the nurse-led     home exercise training programme and those receiving the comparison care. b. There is no     difference in depression between participants receiving the nurse-led home exercise training     programme and those receiving the comparison care. c. There is no difference in quality of     life and health perception between participants receiving the nurse-led home exercise     training programme and those receiving the comparison care. d. There is no difference in     physical activity levels between participants receiving the nurse-led home exercise training     programme and those receiving the comparison care. e. There is no difference in perceived     benefits and barriers of exercise between participants receiving the nurse-led home exercise     training programme and those receiving the comparison care.      The study was a randomized controlled trial conducted in two haemodialysis units of two     tertiary hospitals in Nanjing, China. Participants were randomly assigned to either study     group or comparison group. Participants in both groups received the in-center exercise     training (20 minutes) before haemodialysis sessions weekly for 6 weeks and were instructed to     perform exercise at home. The in-center training was focused on flexibility and strengthening     exercise. Patients were encouraged to have cardiovascular exercises at home which will     improve their cardiovascular conditions and endurance. The list of cardiovascular exercise     included brisk walking, bicycling, jogging. Participants in the study group were instructed     to start walking or brisk walking at low duration and gradually progress to a maximum of 30     minutes daily per week. To facilitate exercise progression, the nurse case managers discussed     exercise benefits, explored exercise barriers and developed mutual goals with patients. The     nurse motivated them and checked the exercise behaviors to ensure adherence to the     recommended exercise regime. The nurse case managers interviewed the study group patients     weekly for six weeks and biweekly for another six weeks. Participants in the comparison group     only participated in the in-center exercise training. The comparison group patients received     usual care from the nurse without the interviews and mutual goals developed.   "
92460|NCT02075866|"     Finnish Genetic Study for Arrhythmic Events (FinGesture is a prospective case-control study     assessing the characteristics and genetic background of consecutive series of autopsy     verified out-of-hospital victims of SCD vs. survivors of an acute coronary event in a     specific geographical area in northern Finland.   "
92462|NCT02075840|"     This randomized, active controlled, multicenter phase III open-label study is designed to     evaluate the efficacy and safety of alectinib compared with crizotinib treatment in     participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced     non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive     either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally     BID. Participants will receive treatment until disease progression, unacceptable toxicity,     consent withdrawal or death. The study is expected to last approximately 42 months.   "
92524|NCT02075021|"     The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane     weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum     toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot     phase II trial. All treatments will be performed until progression. Assessments will be made     at least at the 2, 4 and 6 month timepoints and monthly thereafter until progression.      The purpose of this research study is to determine how much of the combination of Revlimid     and Abraxane can be given safely and how well they work together against the cancer.      Currently, this trial is in the phase 1 stage.   "
92525|NCT02075008|"     This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma     patients who completed study CQGE031B2201.   "
92526|NCT02074995|"     Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15     weeks   "
92463|NCT02075827|"     Previous studies have shown that subjects who play video games are prone to consume larger     quantities of food than subjects who are simply resting. This is believed to be due to the     development of a stress response in the video games group, resulting in increased fuel     metabolism. However, it was shown that the energy intake of the two groups showed no     correlation with the subjects' appetite/hunger, which was identical in both groups.      The investigators propose to explore this issue further by comparing the effects of different     types of video games on metabolism, using a randomized controlled trial. In this study, they     will compare the stress levels, heart rate, blood pressure, appetite/mood, energy     consumption, grip strength, memory and saliva cortisol, leptin and ghrelin levels of subjects     playing (a) competitive and (b) problem-solving video games. Measurements will be taken     preceding, during and after the 1 hour intervention. Following the intervention, participants     will be offered savoury and sweet foods/drinks, which will allow us to assess their appetite     preferences and caloric intake.      The investigators first aim is to determine whether there is a significant difference in     stress levels, eating habits and energy metabolism in the two groups. Our second aim is to     determine whether there is a difference in glucose distribution to the muscles and brain     between the two groups.   "
92466|NCT02075775|"     This project will be a multi-center, prospective longitudinal cohort for all patients     undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be     looking for risk factors for recurrent instability, revision surgery, and poor outcomes.     Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI     outcome measures, as well as demographic and socioeconomic information. Surgeons will     complete a form after surgery with information on radiographic findings, physical exam,     surgical findings, and the repair. The subject questionnaires will be completed over a series     of timepoints and the subject's information from the subjects' electronic medical record will     be abstracted for research data at various timepoints as well. Patients will wear a sling     post-operatively, and follow standardized rehabilitation protocols, including physical     therapy.   "
92467|NCT02075762|"     The objective of this study is to compare the sample size, architectural preservation and     diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) in     comparison to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted     Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease     (ILD).   "
92468|NCT02075749|"     Abstract:      Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief,     correction of nutritional status and improving the performance status. However, lack of     standardization is the major obstacle for any scientific evaluation of any CAM trial.     Mucositis is a major complication of irradiation in head and neck (H&N) tumors, the addition     of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong     demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of     this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films     on oral mucositis in terms of pain control and/or ulcer treatment.      Methods and Materials: the study was a double-blind, randomized prospective trial of two     types of mucoadhesive films in the management of oral mucositis occurred during head and neck     cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO     scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were     enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice     (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films     containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films,     an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.   "
92469|NCT02075736|"     The purpose of this study is to compare safety and efficacy of Green Light PVP     (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients   "
92470|NCT02075723|"     The purpose of this study is to determine if sleep restriction provokes an increase in risk     factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity to     insulin. We propose to evaluate the effect of sleep restriction in a model of metabolic     challenge (overfeeding) caricaturing the conditions of modern societies everyday life .   "
92471|NCT02075710|"     The purpose of this study is to find out how the amount of fat or sugar in a person's diet,     or the number of meals eaten each day, affect the amount of fat that people's bodies make,     the types of fats in the bloodstream, and how much fat is stored in the liver. The study is     funded by the National Institutes of Health.   "
92472|NCT02075697|"     The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis.   "
92473|NCT02075684|"     The purpose of this research study is to create a prospectively maintained, multicenter     database of patients undergoing renal biopsy for renal masses performed percutaneously     (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the     investigators will collect and maintain the data from the biopsy procedure. This will allow     us to evaluate our experience with this procedure as well as to participate in     multi-institutional collaborative studies in the future. At University of California Irvine,     the investigators routinely biopsy patients with renal masses under real-time ultrasound     control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed     to diagnose renal mass histopathology. The safety and efficacy of this procedure has been     well documented in the literature. The indications for percutaneous renal biopsy have     expanded as there has been a substantial increase in the number of renal masses that are     being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel.     The biopsy procedure is part of your normal standard of care and if not being done for this     research project.   "
92527|NCT02074982|"     This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have     plaque-type psoriasis   "
92474|NCT02075671|"     Rosacea is a chronic inflammatory disorder that is characterized by severe flushing     (transient erythema), non-transient erythema, papules, pustules, and telangiectasia. Topical     therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid     recurrence is common following the use of systemic antibiotics, resulting in the chronic use     of these medications to control the disease. Although the exact pathogenesis of rosacea is     unknown, treatment for this condition has been investigated based on its similarity to acne     and photodamaged skin. Case reports have shown promising results in rosacea patients treated     with methyl aminolevulinate photodynamic therapy (MAL - PDT). Other than a case report which     observed significant improvement of papules, pustules, erythema, and flushing following 5 -     aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the     role of ALA-PDT in the treatment of rosacea has not been reported.      We have designed a pilot study investigating the efficacy of ALA-PDT in treating     papulopustular rosacea. The objectives of the study are as follows:      Primary objective:        1. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules),          erythema, and telangiectasia of rosacea as assessed by the Investigator's Global          Assessment (IGA).        2. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of          rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA).           Secondary objectives:        3. To evaluate improvement of rosacea associated erythema as assessed by the Clinical          Erythema Assessment (CEA) scale.        4. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of          rosacea as measured by a difference in inflammatory lesion count.        5. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.   "
92531|NCT02074930|"     It is an open-label physiological investigation of the allergic skin reactivity to     epicutaneous allergen exposition in 20 allergic patients in two different skin conditions.     The focus of the study is on the skin preparation/condition and not on the specific allergen     or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy     was chosen as the basis for the testing. In order to evaluate the effects of the two     different skin preparation techniques an intraindividual comparison of the skin reactivity in     terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was     chosen. The serial dilution approach allows a dose dependent effect evaluation and comparison     of the sensitivity. The differences will be explained mainly by the two different skin     preparations allowing a quantitative comparison of these techniques.   "
92475|NCT02075658|"     Renal cancer has traditionally been treated by surgical removal of the tumor, as the tumors     are resistant to chemotherapy and radiation. The traditional treatment, where the entire     kidney and tumor were removed through an abdominal incision, may now have more long term     problems than the actual cancer. As a result, less invasive techniques have been developed     such as laparoscopic surgery where the abdomen is inflated with carbon dioxide (i.e. via an     insufflation system) and the surgery performed with special instruments through small ports,     known as trocars. Rapid advances in minimally invasive surgical techniques demand ongoing     technological improvement.      Conventional insufflators and trocars allow for laparoscopic surgery to occur, however the     system does not account for pressure changes within the abdomen when instruments are inserted     or removed. The AirSeal® System consisting of an insufflation, filtration, and recirculation     system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal®     Access Port) has been designed to create and maintain the pressure barrier throughout the     procedure. The objective of this study is to collect comparative physiological, pulmonary     compliance and surgical utility data for both the AirSeal® System and conventional     insufflators and trocars in a controlled population undergoing laparoscopic/robotic renal or     peri-renal procedures. Subjects enrolled in this study will have their procedure performed     using either the AirSeal® System or a conventional insufflator and trocars. Both systems have     been cleared for use by the FDA's 510(k) process and are currently employed in clinical     practice, including at University of California, Irvine Medical Center. We hypothesize that     with the use of the AirSeal® System, laparoscopic efficiencies and outcomes will be     significantly greater than with the conventional insufflator and trocars system.   "
92476|NCT02075645|"     A multi-centre prospective cohort study, which examines the effect of a team training     educational intervention for pediatric resuscitation team members. The study uses     simulation-based training as the primary teaching method to evaluate the effect of team     training on team performance, as measured by adherence to PALS guidelines. By re-testing     participants again after 6-12 months, the study will examine long-term retention of these     skills. Hypothesis: adherence to PALS guidelines is improved following team training of     pediatric resuscitation team members.   "
92477|NCT02075632|"     This is a multi-center, open-label study to evaluate whether participants follow the duration     of use instructions for short-term use of alclometasone dipropionate in a population of     participants with itchy skin conditions who would use OTC treatments for relief. The study     population will be composed of two different cohorts: chronic condition sufferers (eczema or     psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison     ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or     soaps) where an anti-itch medication would be used.   "
92478|NCT02075619|"     This is an open-label, single-centre, randomized, single dose, three-way crossover, six     sequence study to evaluate the comparative bioavailability of two Fixed Dose Combination     (FDC) tablet formulations of amlodipine and rosuvastatin relative to innovator samples under     fasting conditions, in healthy adult subjects. Subjects will be 12 Chinese and 12 Caucasian     subjects living in Singapore. The randomisation will be stratified by ethnicity to ensure an     equal number of subjects will be assigned to each dosing sequence. Subjects will receive each     of the following three treatments administered in a randomized three-way crossover design: a     reference treatment consisting of a single 10mg amlodipine tablet and 20mg rosuvastatin     tablet ; a single fixed dose combination tablet consisting of 10mg amlodipine and 20mg     rosuvastatin (Test Formulation - FDC 1); and another single fixed dose combination tablet     consisting of 10mg amlodipine and 20mg rosuvastatin (Test Formulation - FDC 2). Two test     formulations have same active pharmaceutical ingredients (amlodipine and rosuvastatin), same     doses and different inactive ingredients. Each subject will participate in three treatment     periods. The study consists of a screening phase, three treatment periods and a follow-up     visit. The three treatment periods will be separated by a washout period of 12-17 days.   "
92479|NCT02075606|"     Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with     functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are     secreting hormones and are located in the area in the middle of the digestive system) and     their presence usually means that the prognosis for the patient is poor. CTCs have also been     shown to be valuable as predictive markers following treatment and there is increasing     interest in using CTCs as 'liquid biopsies' that can help to inform treatment decisions. CTC     analysis has the benefit of being relatively non- invasive and quick compared with a     conventional CT scan and is therefore an attractive method of monitoring the tumour     throughout the treatment period.      The purpose of this study is to assess the clinical value that enumeration will have in     predicting the clinical symptomatic response and progression free survival in patients     receiving Somatuline Autogel for functioning midgut NETs over a one year period.   "
92480|NCT02075593|"     In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination     (FDC) tablet is being made available to women who become pregnant while participating in     study ING117172. Continuation of antiretroviral therapy (ART) is key to both mother and the     unborn fetus in order to maintain virologic suppression in the mother (thereby decreasing the     risk for maternal disease progression), but also to reduce the risk of maternal-fetal     transmission of human immunodeficiency virus type 1 (HIV-1) to her unborn child. This study     also offers the first opportunity to investigate the impact of pregnancy on DTG     pharmacokinetics (PK). This is an open-label, single arm interventional study. The number of     women that will be enrolled into this study cannot be established a priori, as unintended     pregnancies cannot be determined in advance. The maximum number of women would include all of     those women randomized to DTG/ABC/3TC FDC (approximately 237), though unintended pregnancies     in all of these women would not be anticipated.   "
92481|NCT02075580|"     Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients     modify body image and self-representation. Therefore, the purpose of this study is to     evaluate the efficacy of psychological intervention on patients undergone this surgical     practice.   "
92532|NCT02074917|"     This is a prospective, randomized and double-blind clinical trial about anatomical     single-bundle anterior cruciate ligament (ACL) reconstruction.      One of the most common causes of ACL reconstruction failure is poor graft positioning. There     is evidence that graft placement aligned with native insertion sites results in superior     clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of     the native anatomy to restore physiological knee kinematics more accurately.      This study aims to investigate clinical outcomes and dynamic knee stability with force     platform and other functional tests after ACL reconstruction in two different groups of     tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.      It was hypothesized that there would be clinical or dynamic stability differences between AM     or Central tunnel groups in ACL reconstruction.   "
92482|NCT02075567|"     Background: During and after exercise there is a twofold stimulation of glucose transporter     type 4 in type 1 diabetes mellitus (T1DM) caused by an exogenous insulin injection and muscle     contraction. In case of no insulin reduction before exercise and/or an additional     carbohydrate supplement patients with T1DM would become hypoglycemic. There are no specific     data dependent on individual exercise intensities and strategies of bolus insulin reduction.     The aim of the present study is to avoid hypoglycemia during and after exercise and to     calculate a critical time where blood glucose would decrease to 50% of baseline by a pre     exercise standardized insulin regimen during standardized cycle ergometer exercises dependent     on different modes, intensities and energy expenditures as well as counter regulatory     hormones.      Methods/design: Participants consist of 7 male subjects aged 18 to 35 years with T1DM     (fasting C-peptide (≤ 0.3 nmol/l), HbA1c ≤ 64 mmol/mol). After a four-weeks basal insulin     adaptation of ultralong-acting basal insulin (Novo Nordisk) each subject will perform a     maximal incremental cycle ergometer exercise test with a reduction of short time insulin of     40% to determine the individual aerobic/anaerobic threshold called first/second lactate turn     point (LTP1, LTP2). Four constant load and three high intensity intermittent cycle ergometer     exercise tests (30min) will be performed at 5% Pmax below and above LTP1 and LTP2 (at 5%     above LTP2 no high intensity intermittent cycle ergometer exercise test) with a reduction of     short time insulin doses (standardized breakfast-four hours before each test) of 25% at 5%     Pmax below LTP1 and 50% at 5% Pmax above LTP1 and 75% at 5% Pmax below and above LTP2 with     one week interception between testing. 24h before testing subjects will be fitted with a     continuous glucose monitoring system for at least 48h. Primary outcomes include blood glucose     decrease from baseline during constant load tests, energy expenditure during testing, 24h     CGMS measurements and hormones catecholamines, cortisol, glucagon and insulin growth factor     1. Secondary outcome measurements include heart rate, lactate and respiratory gas exchange     values.      Discussion: If the results confirm the hypothesis, this study could be one of the first     recommendations for T1DM patients, how to adapt bolus insulin dose individually before     defined exercises without the risk hypoglycemia during and after exercise.   "
92483|NCT02075554|"     The primary objective of this study is to evaluate the safety and efficacy of CALIBER     expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes,     intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from     patients in this 2 year follow-up clinical study.   "
92484|NCT02075541|"     The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity     of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with     moderate and severe persistent airflow obstruction.   "
92485|NCT02075528|"     Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of     6-week acute treatment and 52-week maintenance treatment showed positive results in patients     with schizophrenia and its clinical improvement may start at Day 4. Some second-generation     antipsychotics have been found that using the first 2 weeks' treatment results to predict the     fourth or sixth week's treatment response is acceptable.      The primary aim of this study is to investigate:        1. . whether the early prediction model used in other atypicals could also be applied in          paliperidone ER.        2. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER          treatment in this study   "
92486|NCT02075515|"     The purpose of this study is to demonstrate lot-to-lot consistency in terms of     immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study     is designed as a randomized, double-blind study with three parallel groups.   "
92488|NCT02075489|"     This study will provide symptomatic veterans with acupressure treatment and determine its     effectiveness in fatigue relief and pain management for Gulf War Illness (GWI). Investigators     plan to recruit patients reporting symptoms of GWI through the Department of Veterans Affairs     (VA), and randomize them into acupressure group (to receive acupressure treatment) and     control group (to receive Reiki treatment). The acupressure treatment, twice per week for 6     weeks, will be offered by a licensed acupressure practitioner. Evaluations will be made     before and after treatment (at 6 weeks). Clinical outcomes will be compared between groups     (acupressure group vs. control group) and between different timepoints (before treatment vs.     after treatment) within the same group.      The results of this study may provide useful information to develop more effective treatment     for veterans with GWI disease. Since acupressure treatment is of Asian origin and has shown     excellent promise within its Eastern traditions, if successful, this study has the potential     to produce a paradigm shift in clinical practice to more effectively relieve the symptoms of     veterans with GWI disease. Meanwhile, as a non-invasive therapeutic massage, acupressure may     lend to better patient acceptance and ultimately, greater clinical accessibility.      Hypotheses        1. Acupressure besides routine clinical care will produce a more complete fatigue relief          and pain alleviation in veterans with GWI versus routine clinical care plus reiki          treatment.        2. EEG measures will exhibit a positive change when fatigue is relieved and pain is          alleviated for symptomatic veterans after effective treatment.   "
92489|NCT02075476|"     The purpose of this study is to evaluate the effectiveness and safety of two surgical     techniques for the treatments of proximal extremity humeral fractures and fractures luxation     in three o four fragments of Neer's classification.   "
92490|NCT02075463|"     The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb)     concentration, or maintain it within the target range, and the safety and efficacy of     GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia     associated with chronic kidney disease who are chronically hyporesponsive to rhEPO. The data     generated will inform dose requirements for any chronic rhEPO hyporesponsive     hemodialysis-dependent subjects included in future clinical trials. The study consists of a     4-week rhEPO run-in period, a 16-week GSK1278863 treatment period and a 4-week Follow-up     period.   "
92528|NCT02074969|"     The purpose of this study is to assess the differences between two different types of devices     for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is,     that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a     better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).   "
92529|NCT02074956|"     This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in     five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative,     and have no evidence of tuberculosis infection. Since BCG-vaccinated individuals are the     target population for which AERAS 404 might be indicated, AERAS 404 will be administered to     individuals already vaccinated with BCG   "
92530|NCT02074943|"     The investigators plan to conduct a clinical trial to assess the effects and safety of     platelet rich plasma on androgenetic alopecia.   "
92541|NCT02074800|"     The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels     (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2     of this study is to access the pharmacokinetics (what the body does to the study medication)     comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.   "
92491|NCT02075450|"     Our project aims to improve the delivery and assessment of cardiopulmonary resuscitation     (CPR) during pediatric cardiac arrest by introducing 2 novel approaches: 1. We will evaluate     the effectiveness of a novel, credit card sized, and highly affordable nano-card CPR visual     feedback device to improve compliance with HSFC CPR guidelines when used during simulated     pediatric cardiac arrest; 2. We will also develop and study a novel, Just-in-Time (JIT) CPR     training video, integrating proven educational methods (video-based lecture, expert modeling,     practice-while-watching), and use the CPR visual feedback device to provide real-time     coaching.      We hypothesize that:      H1: The use of a CPR visual feedback device will improve compliance with current HSFC CPR and     resuscitation guidelines during a simulated pediatric in-hospital cardiac arrest scenario     compared with standard CPR with no visual feedback.      H2: A JIT CPR Training Video, viewed by healthcare providers 2-4 weeks prior to the     resuscitation event, will improve compliance with current HSFC CPR and resuscitation     guidelines during simulated pediatric cardiac arrest compared with those healthcare providers     with no prior exposure to the JIT CPR Training Video.      H3: That there is poor correlation between providers' perception of CPR quality and actual     measured CPR quality H4: That task load varies depending on provider role and type of     clinical scenario   "
92492|NCT02075437|"     This study will provide tools to develop and pilot an intervention for Functional Abdominal     Pain (FAP) using a ten session intervention with children ages 5-8. Investigators will train     the subjects to be Feeling and Body Investigators. During treatment phases the following     will occur 1) gather clues (learn), 2) investigate (experience: perform interoceptive mystery     missions to explore a body sensation), 3) organize body clues (contextualize: recall other     contexts that evoke similar sensations), and 4) go on increasingly daring missions     (challenge: decrease avoidance and safety behaviors). The FBI intervention will be developed     and refined in 26 child-caregiver dyads during the current R21 phase. In the R33 phase     investigators will randomize 100 subjects with FAP to FBI or an active control group in order     to conduct a pilot-test of the feasibility, acceptance, and clinical significance of FBI.     Young children with FAP who complete the FBI early intervention will learn to experience     changes in the viscera as fun and fascinating, rather than scary, and will develop new     capacities for pain management, adaptive functioning, and emotion regulation. For the R21     Phase (assessing initial feasibility) investigators hypothesize that ≥ 80% of participants     enrolled in FBI will complete treatment and that ≥ 80% of participants will complete     home-based practice assignments.   "
92493|NCT02075424|"     The purpose of this study is to describe biological stress (cortisolemia) and perceived     stress in Emergency Call Center Operators and Doctors while processing a center 15 call.   "
92494|NCT02075411|"     Anterior cruciate ligament repair using hamstring autograft in children is a painful     orthopedic procedure. The current practice to provide analgesia for this procedure include     femoral continuous perineural infusion and femoral single shot peripheral nerve block, along     with perioperative opioids and NSAIDS both IV and orally. Since the use of opioids can be     associated with adverse side effects, which include, but are not limited to nausea, vomiting,     constipation, pruritus and respiratory depression, comparing the amount of opioid used with     either analgesia delivery method is needed.   "
92495|NCT02075398|"     To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside     Respiratory Patient Monitoring System, for performance during motion conditions.   "
92496|NCT02075385|"     General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of     advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy     and radiotherapy concomitant to chemotherapy.      Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced     oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which     had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with     chemotherapy. Patients are randomized on two groups: control group and speech pathology     therapy group   "
92497|NCT02075372|"     The successful re-opening of a blocked coronary artery has a beneficial effect on the further     clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased     heart function, etc.). However, some types of blockages are more difficult to open by means     of percutaneous coronary intervention (PCI), a procedure which is commonly used for these     kind of problems. This procedure makes use of a technique in which special wires, balloons,     stents (metal or polymeric tube-like structures) and devices are utilized to re-open or     revascularize a blockage in one of the blood vessels of the heart. This type of blockages are     chronic total occlusions (CTO). CTOs have certain characteristics which impede the     revascularization of the blood vessel.      Nevertheless, remarkable progress has been achieved over the past few years in the area of     CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as     guidewires, guiding catheters, devices, balloons and stents, as well as different techniques     have been developed. However, at present, reluctance to open CTOs still exists, due to the     indications and outcomes of percutaneous revascularization as well as the technical     difficulties which commonly arise during these interventional procedures. The presence of     these difficulties results in suboptimal success rates worldwide (±70-80%), despite these     many innovations.      To increase these success rates and to make sure more interventional cardiologists will treat     CTOs, a hybrid treatment algorithm has been developed with the materials (e.g. CrossBoss™     catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main     purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as     well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this     algorithm. To be able to do this, data concerning the patients' demographics, CTO     characteristics, procedure and outcome will be collected in the form of a registry. This     registry will be performed in several European centra (Belgium, the Netherlands, United     Kingdom, France). Since the study will only collect data and no intervention is performed,     this will be an observational study. At regular time points, the data will be checked for     errors or inconsistencies. To do this, site visits will be performed at pre-defined times.   "
92498|NCT02075359|"     The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors,     in a wide range of children using energy expenditure measured by respiration calorimetry.     Energy expenditure will be predicted from the combination of heart rate and activity measured     by accelerometry. Prediction equations for energy expenditure will be tested and validated     against a stable isotope method called doubly labeled water for the measurement of     free-living total energy expenditure.   "
92499|NCT02075346|"     Use of an investigational oximetry system to evaluate the triggering of the sensor off     status with the marketed off-the-shelf sensors.   "
92500|NCT02075333|"     The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose     (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive     performance, and blood glucose level.   "
92624|NCT02073721|"     The use of electrical stimulation to reduce urinary incontinence in men undergoing     prostatectomy exercises of the pelvic floor muscles (MAPs)   "
92501|NCT02075320|"     Purpose: The proposed research, if successfully implemented, will result in a low-dose,     low-cost, and highly effective method for screening of lung cancer, leading to reduction of     the lung cancer mortality rate. Using the s-DCT system the imaging dose for a full     tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted     imaging time of 2s is 1/5 to 1/3 of that from a current commercial DCT system at the same     imaging dose. Beyond lung cancer screening, the low-dose and sensitive 3D lung imaging     modality will likely to find applications in areas such as monitoring of pediatric cystic     fibrosis patients where reduction of imaging dose is critical.      Participants: One hundred (100) patients undergoing a clinical non-contrast CT for their lung     nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week) of their     clinical CT and chest radiograph, with no intervening procedures or therapies.      Procedures (methods): The purpose and endpoint of this study is to compare the sensitivity of     the s-DCT system to the conventional chest radiographs with non-contrast chest CT as the     reference standard. One hundred (100) patients undergoing a clinical non-contrast CT for     their lung nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week) of     their clinical CT and chest radiograph, with no intervening procedures or therapies.   "
92502|NCT02075307|"     Obesity usually brings with it disturbances in the body that increase the chances of     developing serious diseases like diabetes and cancer. These disturbances include one or more     symptoms of a condition called metabolic syndrome that often leads to diabetes. High levels     of damage to the DNA that makes up our chromosomes have also been observed in obese people.     It is possible that these two disturbances are connected. The goal of this project is to test     this whether consumption of blueberries will improve these abnormalities.   "
92503|NCT02075294|"     It is estimated that 350-400 million people have chronic infection with hepatitis B virus     (HBV) all over the world. In china, 93 million individuals suffer from this chronic     condition. Currently, seven medications are approved for the treatment of hepatitis B: two     formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one     of the longer average life spans, and the size of the aged population has been increasing     rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the     potential for development of cirrhosis or hepatocellular carcinoma in such patients is real.     Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has     become first choice due to the more side effect of INF and the resistant of LAM and LdT. But     treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will     evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older     patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV     therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the     emergence rate of side effect.   "
92504|NCT02075281|"     The purpose of this study is to determine the optimal dose and regimen of HM11260C, in     combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise     considered in stable health.   "
92505|NCT02075268|"     An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of     Prasugrel 30 mg or 60 mg in healthy male adult subjects   "
92506|NCT02075255|"     The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS     in systemic corticosteroid dependent patients with severe refractory asthma with elevated     eosinophils.   "
92507|NCT02075242|"     Study to Compare the Safety and Efficacy of Tacrolimus and Steroids in Combination With     Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation with     Hepatitis B Virus(HBsAg) Positive   "
92508|NCT02075229|"     Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently     available multichannel cochlear implant systems for newly implanted adults with an indication     based on open-set sentence recognition that expand criteria currently used by Center for     Medicare & Medicaid Services (CMS), and 2) to assess the correlation between measures of     speech recognition in candidates for cochlear implants and their utility in predicting     audiologic and quality of life outcomes after implantation.      Participants: Adults (≥ 65 years of age) and CMS-eligible as a primary source of medical     insurance coverage.      Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in     a patient population that does not meet current CMS candidacy criteria.   "
92509|NCT02075216|"     Muscle precursor cells constantly regenerate striated muscles, and include the quiescent     satellite cells located beneath the basal lamina of skeletal myofibers, which are responsible     for repair of the terminally differentiated striated muscle tissue. Transurethral     implantation of autologous myoblasts may represent an improved alternative to synthetic     bulking agents, with the unique ability to compensate for the deficient muscle fibers in the     urethral sphincter. Clinical studies of cell therapy based treatment of sphincter     insufficiency, using muscle derived stem cell transplantation was carried out in patients     with stress incontinence revealed and confirmed the ability of cell therapy to improve the     structure and contractile function of the sphincter. In this study autologous heterotopic     myoblasts will be transurethrally injected in patients with bladder extrophy epispadias     complex who remained incontinent after staged bladder reconstruction and bladder neck     reconstruction.      The aim of this study is to investigate the potential therapeutic effects of autologous     myoblast injection for the treatment of children presenting with urinary incontinence after     modern staged repair and bladder neck reconstruction of extrophy-epispadias complex as well     as studying the safety, efficacy and durability of the procedure, and health related quality     of life.   "
92510|NCT02075203|"     Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety,     Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and     BCG Revaccination in Healthy Adolescents   "
92511|NCT02075190|"     The objective is to examine the efficacy of computerized interventions for increasing     well-being and cognitive functioning. The study will seek to validate emerging online     delivery methods of psychiatric assessment and treatment. This will allow us to test the     efficacy of this intervention in a larger and more geographically broad sample than is     possible through traditional recruitment and treatment, and to do so in a highly     cost-effective manner.   "
92656|NCT02073305|"     The purpose of this study is to prospectively evaluate the impact of sleep apnea on the     cardiovascular morbidity and mortality of patients with end-stage renal disease.   "
92512|NCT02075177|"     Currently there is no known effective treatment for recurrent/resistant neuroblastoma.      Fenretinide is an anticancer agent that may work differently than standard chemotherapy     medicines. It may cause the buildup of wax-like substances in neuroblastoma cancer cells,     called ceramides or other chemicals, called 'reactive oxygen species'. In laboratory     studies it was found that if too much ceramide or reactive oxygen species build up in     neuroblastoma cells, they may die.      In addition, researchers are testing to see if a drug called ketoconazole, commonly used to     treat fungus infections, can increase fenretinide levels in the body by interfering with the     body's ability to break down fenretinide.      This study is being done: 1) to allow patients with recurrent/refractory neuroblastoma     patients who would otherwise not be able to access fenretinide/LXS oral powder for treatment     to do so; 2) to further describe the side effects of fenretinide and ketoconazole when given     by mouth for seven days every three weeks; 3) to determine if a patient's tumor gets smaller     after treatment with fenretinide oral powder plus ketoconazole or fenretinide oral powder     alone.   "
92513|NCT02075164|"     Non-alcoholic fatty liver disease (NAFLD) comprises a spectrum ranging from simple fatty     liver over steatohepatitis (NASH) to liver cirrhosis and cancer (HCC) and is a major and     increasing health problem affecting nearly 40% of the general population. Moreover, NAFLD is     an important risk factor for progression of diabetes and atherosclerosis. However, the     pathomechanisms determining disease progression are poorly understood. The overall aim of     this project is to test the central hypothesis that excessive fructose consumption provides a     multiple metabolic hit in the pathogenesis and progression of NAFLD/NASH by impairment of     hepatic lipid homeostasis and mitochondrial function resulting in hepatic lipotoxicity with     inflammasome activation and disturbed interorgan cross-talk among insulin sensitive tissues.   "
92514|NCT02075151|"     According to World Health Organization (WHO) estimates, more than 200 million people suffer     from asthma worldwide and in 2009, the disease had claimed 250,000 lives globally. Autopsy     reports suggest 2 phenotypes of severe asthma: one that is characterized by intense airway     inflammation with mucus plugging, and the other by severe bronchoconstriction causing     respiratory failure in the absence of significant airway inflammation. However, it is not     easy to stratify patients according to phenotypes without bronchoscopy. Although severe     asthma comprises only 10% of affected individuals, it accounts for more than half of the     total healthcare spending on asthma. Inhaled corticosteroids are effective by suppressing     production of multiple pro-inflammatory mediators, unfortunately efficacy plateaus. Addition     of long acting beta agonist and anti-cholinergic agent to inhaled corticosteroids offers some     measure of relief but effective treatment of severe asthma remains an unmet goal, resulting     in intensive utilization of healthcare resources. In 2010, the United States Food and Drug     Administration (FDA) approved bronchial thermoplasty (BT) as an adjunctive therapy for severe     asthma. BT is radiofrequency ablation of airway smooth muscle via bronchoscopy with each     patient undergoing three procedures which targets different lobes of the lung 3 weeks apart.     Studies have demonstrated improved symptom control allowing discontinuation of oral steroids     in some patients as well as reductions in exacerbations, hospitalizations and use of rescue     medications. No development of airway strictures or bronchiectasis, and regeneration of     normal epithelium after BT has been observed. At present, it remains unclear if BT benefits     all asthma phenotypes or if BT has any effect on airway inflammation and remodeling.      The hypothesis of this study is that bronchial thermoplasty is likely to benefit all severe     asthma phenotypes, and achieves this by exerting an effect on airway inflammation and     remodelling.      The specific aims of the study are: 1) to better define the asthma phenotype who will benefit     from BT by microarray and gene expression profiling; 2) to study effects of BT on airway     inflammation; 3) to define its role in the overall asthma management algorithm   "
92515|NCT02075138|"     Grass pollen allergens are universally recognised as a major cause of allergic diseases in     humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.      The purpose of the current study is to evaluate allergy symptoms and allergy medication in     subjects with grass-related rhinoconjunctivitis.   "
92516|NCT02075125|"     To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment     elevation myocardial infarction undergoing primary percutaneous coronary intervention.   "
92517|NCT02075112|"     The purpose of this study is to determine if soy supplementation during chemotherapy and     radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a     side effect of the standard treatment, and we are testing whether soy supplementation during     treatment may reduce this symptom and other side effects of chemoradiation.   "
92518|NCT02075099|"     Blood donation is a generous act carried out by healthy male and female volunteer donors. The     safety of blood donation in France is based on rigorous well documented biological and     medical criteria, in particular concerning the volume of blood to be taken. While whole blood     donation is very safe, some donors experience faintness during or after donation. Any injury     resulting from a fall increases its seriousness, especially when it happens outside the     donation site.      According to various studies, adverse reactions are experienced by between 0.28% and 2.72% of     all donors and occur in all categories (sex and age).      A retrospective evaluation of the frequency of faintness incidents on during whole blood     donation over 2012 in the Rhone Alpes' region of France shows a frequency ranging from 1.05%     in mobile donation units in towns to 4.24% in donation units in high schools, with no     reporting of delayed incidents of faintness by this donor population.   "
92519|NCT02075086|"     A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev)     maintain the same sensitivity after progression to maintenance treatment because they remain     dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic     switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev     chemotherapy combinations .   "
92520|NCT02075073|"     The purpose of this study is to compare the pharmacokinetics, safety, tolerability and     immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in     healthy male subjects.   "
92521|NCT02075060|"     The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative     instillation of mitomycin C compared to the standard early post-operative .   "
92522|NCT02075047|"     The purpose of this study is to determine if ziprasidone is safe and effective for the     treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).   "
92523|NCT02075034|"     This study will compare the dosing regimen of oral rigosertib, which has been used in other     studies of lower risk Myelodysplastic Syndrome (MDS), with 2 new dosing regimens to determine     if one of the new regimens gives improved results as measured by disease status, side     effects, and analyses of blood and urine samples.   "
92562|NCT02074527|"     Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to     realize a record that reflects a national overview of the role of cardiac catheterization in     patients with congenital heart disease in hospitals distributed by geographic density of each     region of Brazil.   "
92533|NCT02074904|"     The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI) to     examine the effects of topiramate on brain and behavioral responses in heavy drinkers to     appetitive alcohol reminders (cues that motivate continued alcohol use and relapse). This     project will yield novel findings on brain and behavioral responses to alcohol cues, the     effects of topiramate on alcohol cue reactivity, and the mechanisms underlying topiramate's     ability to blunt alcohol cue reactivity and heavy drinking.   "
92534|NCT02074891|"     A health services implementation pilot study, conducted with an observational cohort of     HIV-uninfected persons including men who have sex with men, heterosexual women and men, and     injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at     four federally qualified health centers that provide sexual health and primary care services     to communities with high HIV incidence/prevalence.   "
92535|NCT02074878|"     This is a Phase 1 Trial. Crizotinib is a medication that is taken by mouth. It has shown that     it can help slow down or stop the growth of tumor cells. The marketing name of the drug is     Xalkori. It has been approved by the FDA (Food and Drug Administration) to treat other     types of metastatic cancer, but the investigators believe it may be helpful to treat breast     cancer as well.      Sunitinib is the other medication used in the study. It is also taken by mouth in the form of     a capsule. The marketing name of this drug is Sutent. It too has been approved by the FDA     to treat other types of cancer, but not for breast cancer.      In this study the investigators will be combining both of these two treatments, but at     different doses.      One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg     once a day.      One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg     once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with     Sunitinib 37.5 mg once a day.   "
92536|NCT02074865|"     The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal     and childhood bacterial infections in low-income countries,in particular those caused by     antibiotic resistant bacteria. This program will address both healthcare associated, as well     as community acquired infections. Beside its main challenge, the ChARLI program will also     allow the assessment of the economic burden of these infections, the improvement of their     medical care and then ultimately help to set public health interventions and guide public     health measures necessary to combat bacterial infections and bacterial resistance in     children. It will also lead to set up more basic research investigation to better understand     how pathogenic and epidemic may be the resistant clones in these countries and to experiment     innovative strategies devoted to prevent these infections.      In order to achieve these objectives, an international paediatric cohort will be created, and     monitored a platform. This will be done first within the Institut Pasteur International     Network (IPIN) and possibly extended in some others low income countries where the IPIN has     no center. This constituted initiative will represent the first international pediatric     program of its size to be located in low-income countries and specifically focusing severe     bacterial infections and bacterial resistance to antibiotics   "
92537|NCT02074852|"     The objective this trial is to compare immediate and 12 hours postoperative removal of     urinary catheter after elective cesarean section; and whether early removal is associated     with lower risk of urinary infection compared with delayed catheter removal.   "
92538|NCT02074839|"     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,     pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that     harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where     cohorts of patients will receive ascending oral doses of AG-120 to determine maximum     tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is     a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate     the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated     time on study treatment is until disease progression or unacceptable toxicity occurs.   "
92563|NCT02074514|"     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF)     + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus     (HCV) infection.   "
92675|NCT02073058|"     The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose     Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose     (BG) reference using the Consensus Error Grid. During the course of the wear duration, the     subject is required to test fingerstick glucose measurement at least eight (8) times a day     for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours     each for venous reference glucose measurements. With every reference measurement, the subject     or study staff will perform a measurement on the System.   "
92539|NCT02074826|"     This prospective, single-centre cohort study aims to investigate the association between     known genetic Atrial Fibrillation (AF) risk variants and the amount of left atrial fibrosis     found in patients undergoing clinically indicated AF catheter ablation procedures.      Left atrial fibrosis is increasingly recognized as a fundamental part of the     pathomorphological substrate creating an electrophysiological environment needed for     electrical conduction heterogeneities. Such identification and treatment of left atrial     fibrosis has already entered routine clinical use for RF catheter ablation in an attempt to     develop an individualized and tailored treatment strategy. Today, it is unclear what impacts     the development, the extent and the localization of left atrial fibrosis in different     patients.      A number of genetic risk variants have been described that confer risk of AF and have been     widely replicated. This indicates that genetic variants contribute to the risk of the     individual to develop AF throughout his life. However, the mechanisms of how genetic variant     impact the development of clinical arrhythmias is not yet well understood.      We hypothesize that genetic influences that lead to tissue changes may play a role in the     development of the arrhythmia substrate for AF. This is likely to be especially true for     those with a relatively brief history of AF and modest clinical disease burden. Therefore, we     plan to investigate the association between known genetic AF variants and a detailed disease     phenotype obtained from individual left atrial voltage mapping.   "
92540|NCT02074813|"     Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a     significant improvement of dyspnea in subjects with severe or very severe COPD than a     conventional pulmonary rehabilitation program alone.   "
92542|NCT02074787|"     Burn injuries are a common presentation to A&E in the UK (175,000 per year) of whom 13,000     require hospital admission. Treatment of a single burn can cost more than £63,000, and is     ultimately dependent on the depth. Most burns are assessed by experienced clinicians within a     few days of injury. Accurate evaluation of burn depth can be very difficult with the naked     eye. Inaccuracy can lead to longer hospital stays, worse scarring and greater financial costs     for the NHS. Where the burn depth (and the degree of damage to the underlying blood supply of     the skin) is not clear by visual inspection, adjuncts may be used to aid clinical     decision-making. Currently, the gold standard method of assessing skin blood flow in order     to help burn specialists in their assessment of burn depth is Laser Doppler Imaging (LDI).     However, LDI machines can be very large, slow to collect the images, and a single imaging     unit costs roughly £50,000. Consequently their use is restricted to the assessment of small     burns in compliant patients treated in specialist units. Thermal imaging (thermography) has     evolved rapidly as a useful diagnostic tool in many medical disciplines. Previous studies     have shown that there are significant changes in skin physiology (such as temperature and     pigmentation) depending on the depth of the burn. Portable, high-resolution thermal cameras     are now affordable, easy to use and can provide numerical results in under a second.     Similarly, measurement of skin pigment levels can be achieved using portable devices such as     the Spectrophotometric Intracutaneous analysis scope (SIAscope). The aim of this study is to     determine if alternative measures such as thermography or SIAscope can be as useful in the     assessment of adult burns as LDI currently is. If this study demonstrates this then these     results will inform further studies that would investigate these alternative imaging methods     as a diagnostic and prognostic tool in the management of burns not only in adults but also in     children presenting to non-specialised units such as A&E.   "
92543|NCT02074774|"     The overall objective of this study is to demonstrate that the IntellO2 device providing     automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously     breathing infants with fluctuating arterial blood oxygen saturation levels is safe and     efficacious in the routine clinical environment. Specifically, it is hypothesized that the     IntellO2 will perform as well or better than standard practice for maintaining infants'     arterial blood oxygen saturation in a target range while minimizing the exposure to elevated     levels of oxygen in the inspired gas.   "
92544|NCT02074761|"     Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to     evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.   "
92545|NCT02074748|"     This study is an observational change from baseline outcome measures design. Data is     collected for the sake of evaluating treatment (fusion surgery) performed as standard medical     care, but the investigator does not assign specific interventions to any participants in this     study.   "
92546|NCT02074735|"     The purpose of this study is to determine if citicoline, as an add-on therapy, will help     reduce alcohol use in outpatients with alcohol dependence.   "
92547|NCT02074722|"     Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices,     has become increasingly prevalent due to an increase in awareness of the potential health     benefits, and improvements in concentration that this training can provide to practitioners.     In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the     initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).      The PI's hypothesis is that MBAT will improve performance in SMR based BCI.   "
92548|NCT02074709|"     In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after     ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound     infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.   "
92549|NCT02074696|"     The purpose of the study is to assess the status of brain-derived neurotrophic factor brain     (BDNF) and how the brain behaves in response to skill acquisition. Specifically we will     investigate the relationship of the status of BDNF with cortical excitability changes and     learning that occur during a motor training paradigm. We aim to 1) determine cortical     excitability changes by using transcranial magnetic stimulation (TMS) before and after     training; 2) to determine finger tracking accuracy before and after training; and 3)     determine the presence of BDNF polymorphism in each participant.      We are testing healthy adults in this study, and eventually would like to apply to persons     who have neurologic disorders such as stroke or dystonia. By applying a magnetic field to the     outside of the head, electrical currents are produced within the brain that can stimulate     brain tissue. Using TMS, the brain can be studied to gain a greater understanding of the     mechanisms associated with cortical excitability in healthy and patient populations. There is     limited knowledge of what influence genetic biomarkers such as BDNF have on cortical     excitability changes within the cortex following learning. Studies have indicated that people     without this certain gene are less likely to show changes in brain excitability during TMS     and during motor learning than people with this gene   "
92550|NCT02074683|"     The etiology of plantar fat pad atrophy may be age-related, due abnormal foot mechanics,     steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to     osseous prominences in the forefoot that may be seen with painful skin lesions. Disease     states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy, regardless     of the etiology, may result in significant pain, epidermal lesions, or metatarsalgia. In     sensate patients, the pain can lead to emotional and physical pain, leading to productivity     and financial losses.      It is well documented that plantar pressure is directly correlated with plantar tissue     thickness, with the loss of plantar fat being a fundamental mechanism for pressure related     foot disorders.Autologous fat grafting to areas of plantar fat pad atrophy may reduce plantar     pressures, and thus serve as a treatment for metatarsalgia, corn and callus prevention, and     possibly ulcer prevention in diabetics. Plastic surgeons, with significant skills in fat     grafting, can make a significant contribution.      Current treatment modalities for fat pad atrophy include silicone injections, fat injections,     and other temporary fillers; however, no objective studies using autologous fat have been     performed. Approximately 30 adults who experience pain from fat pad atrophy, will have the     option to participate. Through a randomized, controlled, cross-over study, some patients will     receive autologous fat grafting, while some will receive standard of care podiatric     treatment, then cross-over to fat grafting treatment after a year. Through pedobarograph and     ultrasound assessments, the focal pedal pressure and tissue thickness following treatment     will be documented over two years.      We hypothesize that fat grafting for areas of increased pedal pressure in well-controlled     diabetics will help decrease foot pressure during gait and increase soft tissue thickness on     the foot pad, ultimately reducing pain. We also hope to demonstrate that by using autologous     fat with evidence-based fat transfer techniques, results may be durable. This pilot study     will help build new collaborative efforts between Foot and Ankle Surgery, Podiatry and     Plastic Surgery, combining expertise in foot biomechanics with reconstructive fat grafting.   "
92551|NCT02074670|"     The purpose of this study was to evaluate the potential reorganization in the sensorimotor     cortex in spinal cord injury (SCI) patients after Body Weight Supported Treadmill Training     (BWSTT) associated with conventional motor rehabilitation. The investigators hypothesized     that training with weight bearing associated with conventional motor rehabilitation will be     able to reorganize the brain.   "
92552|NCT02074657|"     To determine safety profile of immunotherapy with natural killer cells and activated expanded     (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or     refractary acute leukemia   "
92553|NCT02074644|"     The purpose of this study is to determine whether prostatic arterial embolization (PAE)     compared is an effective and safe treatment for benign prostatic hyperplasia in patients with     severe lower urinary tract symptoms not adequately controlled by medical therapy with     alpha-blockers, as assessed by the the International Prostate Symptom Score (IPSS) after 6     months. Patients will be randomized on a 1:1 ratio to PAE or to a sham procedure and     evaluated at 1, 3 and 6 months. Patients randomized to the sham procedure will be offered the     possibility of performing PAE after 6 months. All patients may participate on an optional     6-months extension study.   "
92554|NCT02074631|"     This is a Phase 2, open-label, randomized, controlled clinical study of pediatric subjects     treated with pamidronate with calcium and vitamin D versus calcium and vitamin D alone     following hematopoietic cell transplantation (HCT). The purpose of this study is to test the     hypothesis that subjects receiving pamidronate with calcium and vitamin D will have higher     lumbar spine bone mineral content (LBMC) measured by dual-energy X-ray tomography (DXA) at 1     year post-HCT than subjects receiving calcium and vitamin D alone (Control Group).   "
92555|NCT02074618|"     The purpose of this study was to evaluate the effects of physiotherapy based on the practice     of supervised exercise on functional capacity and life quality of patients with chronic     kidney disease.   "
92556|NCT02074605|"     Interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed     with high risk malignant melanoma (stage 2 or 3). There is evidence that interferon has some     adverse cognitive effects on patients, but there are limited data. The investigators     hypothesis is that compared to patients with melanoma who do not receive interferon, patients     who have melanoma and are treated with interferon will show an objective decrease in     performance on neurocognitive assessment.      This study will enroll patients with melanoma who qualify for interferon, and either decide     to undergo interferon treatment or choose watchful waiting instead. All patients will be     assessed with a cognitive testing battery twice. Observation patients will undergo testing at     their first appointment in which they consent to the study, as well as at their next     physician visit, approximately 3 months from the first visit. Interferon patients will be     tested immediately prior to starting interferon, as well as immediately after completing high     dose interferon.   "
92557|NCT02074592|"     To improve the quality of fetal ultrasound images, self assessment is less resource consuming     than assessment by an expert reviewer, and may be as effective.      To test this hypothesis, we randomize volunteer experienced ultrasonographers into two     groups.      One group assess their own images (self assessment). The other group has their images     assessed by an expert. Images are audited via the internet in a standardized procedure that     generates feedback with recommendation for change.      Three to 6 months later, participants are audited again. If the improvement in image quality     turns to be the same in both groups, it will be likely that self assessment is indeed as     effective as assessment by an expert reviewer - at least for professionals experienced in     fetal ultrasound.   "
92558|NCT02074579|"     The aim of this study is to assess the effect of orally administered TU-100 (5 g three times     daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients.   "
92559|NCT02074566|"     Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial     fibrillation. However, with the rapid evolution in cryoablation technique and its increased     effectiveness, the risk of complications increases. Therefore it is of utmost importance to     define the optimal duration of cryoballoon ablation time.The objective of the study is to     assess the optimal ablation duration using the second generation cryoballoon for isolation of     pulmonary veins in the treatment of atrial fibrillation.   "
92560|NCT02074553|"     This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period     cross-over study will compare the bioequivalence of three test alectinib capsule formulations     with the reference capsule formulation in healthy adult participants. All participants in     both fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4     treatments: Treatment A (alectinib with 50 percent [%] sodium lauryl sulfate [SLS]     [reference]), Treatment B (alectinib with 25% SLS [test]), Treatment C (alectinib with 12.5%     SLS [test]), and Treatment D (alectinib with 3% SLS [test]) in a randomized sequence. Each     treatment will be given as a single 600 milligrams (mg) oral administration in an upright     position on Day 1 in a fed or fasted condition, followed by a 10-day washout period.   "
92561|NCT02074540|"     To determine the predicting factors and indicators of compliance with insulin treatment in     Diabetes Type II patients.   "
92564|NCT02074501|"     Background: More than 42% of older people (aged +65) have a stroke and most of them require     some type of help to self-care at home. Informal caregivers have reported different types of     need and have shown dissatisfaction with technical and emotional support delivered by     community health teams. Furthermore, empowering informal caregivers who care after older     stroke survivors is an important challenge, preventing them from negative outcomes such as     burden, anxiety and depression or loss of physical function or hospitalization in older     people.      Objectives: This pilot study aims to implement and evaluate the impact of an intervention     based on training and telephone support delivered to informal caregivers who care after older     people post-stroke.      Setting: Community health units in Northern Portugal region. Design/Methods: This single     blinded randomized trial will be delivered by a community nursing team to informal caregivers     1 week, 1 and 3 months after a hospital discharge.      Study outcome(s): The primary outcomes will be informal caregivers´ empowerment. Secondary     outcomes will include burden and health quality of life in caregivers; functionality,     hospital readmission and institutionalization of older people stroke survivors, measured 1     and 3 months after intervention.      Results/Conclusion: Data collection started in February and will be concluded in August 2014.     First results will be published at the beginning of 2015. The InCARE programme will be the     first pilot in informal caregivers study ever conducted in Portugal. It will highlight new     ways to support caregivers who take care of older people after a stroke. If successful, this     study will be translational and it will also allow to disseminate the results in Portugal and     abroad and implement it as best practice.   "
92576|NCT02074345|"     The purpose of this study is to evaluate the safety and immunogenicity of intramuscular     TAK-816 in healthy Japanese infants.   "
92577|NCT02074332|"     The primary objective of this study is to assess the effectiveness of a school based physical     activity programme on obesity and related health outcomes in young schoolchildren.   "
92565|NCT02074488|"     Falls are a significant issue for older adults with vision impairment. Medical conditions     such as glaucoma and age-related macular degeneration that result in vision impairment     negatively impact balance. Falling is 1.7 times more likely among older adults with vision     impairment. In 2010 there were 9,146,026 older adults treated in emergency rooms for     unintentional falls and injuries from falls are expected to cost the nation an estimated     $54.9 billion dollars by 2020. Falls can lead to death, depression, and loss of independence.     However, impaired balance is a modifiable risk factor for falls. A practical yet innovative     falls prevention program has been developed that is designed to enhance balance and     proprioception among older adults. This program, UExCEL (UNE-Exercise and Conditioning for     Easier Living) Balancing Act, consists of simple exercises that can be done at home (15     minutes duration-3 times a week) during normal daily activities, requires only one brief     training session, and no equipment. This study aims to establish an evidence base documenting     the positive impact of Balancing Act exercises on balance and falls prevention for older     adults with vision impairment. A randomized controlled trial of older adults with vision     impairment (best corrected vision of 20/70 or worse) will be conducted over a 6-month period     (control group n = 35 and Balancing Act intervention group n = 35) to determine the impact of     Balancing Act on falls, fear of falling, pain, and activity levels. Factors that can be     expected to affect its adoption and sustained use such as cost in the community and social     support networks in the home will also be investigated. It is hypothesized that the Balancing     Act intervention will decrease the number of falls experienced by older adults who have     vision impairment by improving their gait and balance, reducing their fear of falling,     increasing their physical activity, and reducing their pain.      The specific aims of the research are to: 1) Evaluate the impact of Balancing Act on standing     balance control and proprioception for older adults who have vision impairment, using the     Tinetti Gait & Balance Test, a validated tool for evaluating gait and balance and predicting     fall risk; 2) Evaluate the impact of Balancing Act for older adults with vision impairment on     falls, fear of falling, physical activity, and pain; and 3) Improve adherence to the     Balancing Act exercise program by facilitating social networks. Data will be analyzed     through: 1) a descriptive assessment of the baseline demographic characteristics of sample     members, covariates, and outcome variables, as well as 2) a repeated measures design     examining the impact of the intervention on study participants.   "
92566|NCT02074475|"     Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth     Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which     is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography.     SPI indicates the balance between intensity of surgical stimulation and the level of     anti-nociception (opioid analgesia and neural blockade). This study is a Spin off from a     larger Adequacy of Anaesthesia study and aims on finding the most appropriate target range     for SPI in order to avoid signs of inadequate anaesthesia. Patients are treated without     monitoring adequacy of anaesthesia thus the values are collected blinded and analyzed     afterwards in accordance of signs for inadequate anaesthesia. The study population will be     150 patients.   "
92567|NCT02074462|"     Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between     the efficacy and safety of voriconazole and voriconazole trough concentrations. There are     several factors that could influence voriconazole concentrations. Inflammation could be one     of these factors. In a retrospective study was observed that reduced metabolism of     voriconazole was related to inflammation in patients with severe infections. Reduced     metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite     (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an     algorithm to guide dosing of voriconazole during severe inflammation and to develop a     multiple linear regression model to describe the contribution of CRP concentrations to the     variability in voriconazole levels and metabolic ratio.   "
92568|NCT02074449|"     Patients with pulmonary arterial hypertension (PAH) are at much higher risk of death if the     RV (right ventricle) is weak. The purpose of this study is to get a better understanding of     the factors that determine RV adaptation and how the RV compensates on therapy. The     investigator is also interested in how Remodulin (treprostinil) infused over a short period     (approximately 48-72 hours) affects the patient's quality of life, medical care, and personal     health behaviors.      Treprostinil, also known as Remodulin, has been approved by the US Food and Drug     Administration for use in the treatment of PAH. The investigator has been treating patients     with Remodulin by rapid infusion (over 48 hours) for over 6 years. The investigator would     like to establish this practice as safe and effective for the benefit of other centers that     treat PAH.   "
92569|NCT02074436|"     STUDY BACKGROUND AND PURPOSE:      Patients with hematological malignancies (blood-related cancers) often develop     thrombocytopenia (low platelet count), which can be made worse by cancer treatment.      Preventive (prophylactic) platelet transfusion remains the standard of care for     thrombocytopenic patients. However, bleeding remains a significant problem in these patients,     affecting approximately 20% of patients with acute myeloid leukemia and 34-58% of     hematopoietic stem cell transplant recipients. Platelet transfusion refractoriness, the     repeated failure to obtain satisfactory response to platelet transfusions, is a common     problem. Alternatives to platelet transfusions are desperately needed for these patients.      Epsilon aminocaproic acid (EACA) blocks a process called fibrinolysis that is an essential     step in the bleeding process. EACA is approved by the FDA for the treatment of severe     bleeding-related diseases and complications. A small study has shown EACA to be well     tolerated and associated with low risk of bleeding in patients with hematological     malignancies.      This study will compare EACA versus standard prophylactic platelet transfusion for the     prevention of bleeding in thrombocytopenic patients with hematological malignancies.      STUDY DESCRIPTION:      This is Phase II study to compare EACA versus standard prophylactic platelet transfusion to     prevent bleeding in thrombocytopenic patients with hematological malignancies. Patients who     are eligible to take part must give their written agreement before they can be enrolled.      The study will enroll 100 patients who will be assigned randomly to take EACA twice daily or     to undergo standard prophylactic platelet transfusion. Patients will be followed for any     bleeding events, need for platelet transfusion, and any side effects experienced. Patients     will complete questionnaires to assess their quality of life while on the study.   "
92572|NCT02074397|"     The objective of this randomized controlled trial is to compare the analgesic efficacy and     the safety profile between two techniques of injection for the interscalene block. The     interscalene block consists of injecting local anesthetic around the cervical roots of the     brachial plexus and allows analgesia after shoulder surgery.      Stated differently, the dual objective of that study is:        1. to confirm that an injection at a distance of 4 mm away from the lateral sheath of the          plexus (distal injection) provides similar analgesia as a classical injection within the          plexus (subfascial injection);        2. to demonstrate that a distant extrafascial injection produces less respiratory          complications than a subfascial injection, defined as hemidiaphragmatic paresis.   "
92573|NCT02074384|"     International Diabetes Center (IDC) proposes a preference and usability study of glucose data     acquisition and reporting, evaluating streamlined standardized cloud-based glucose reporting     including work flow as well as patient and clinician preference at Type 1 Diabetes (T1D)     Exchange sites to enhance standard Ambulatory Glucose Profile (AGP) reporting. This phase 2     project assesses the efficacy of standardized glucose data report generation and preferred     report presentation format; both are necessary to increase use of continuous glucose     monitoring (CGM) data to improve care processes and outcomes for Type 1 diabetes.   "
92574|NCT02074371|"     Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory     depression. In this study we aimed at investigating perioperative parameters that could     predict the nadir of postoperative respiratory function impairment.   "
92575|NCT02074358|"     The purpose of this study is to assess the effect of two 4-Factor PCC formulations on     Apixaban pharmacodynamics in healthy adult subjects.   "
92579|NCT02074306|"     The purpose of this study is to examine the effect of UROSHIELD® (a device which generates     low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in     patient receiving mechanical ventilation, and to determine whether this device lowers the     rate of bacterial resistance to antibiotics.   "
92580|NCT02074293|"     Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are     typically injected. All nerves terminate on the fascia, where ASIS device can precisely     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse     reactions and distant spread, especially since Botox has no reason to travel to the rest of     the body any way.   "
92581|NCT02074280|"     Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and     increased intestinal permeability all leading to an increase in bacterial translocation and     increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral     administration and exhibits broad spectrum antimicrobial activity against both aerobic and     anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.     It has been suggested that oral prophylactic antibiotics or bowel decontamination might     improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore     the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of     advanced cirrhosis.   "
92582|NCT02074267|"     The purpose of this study is to assess the efficacy of Gabapentin (Carbatin & Neurontin) in     patients with neuropathy pain.   "
92583|NCT02074254|"     Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake     Inhibitors   "
92584|NCT02074241|"     The purpose of this study is to try to figure out some bio-markers of chemosensitivity for     adjuvant chemotherapy for bladder cancer.   "
92585|NCT02074228|"     Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity     and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term     impairing disorder with tremendous impact on individuals, families, and societies. It affects     5-10% of school-aged children worldwide (7.5% in Taiwan) and 2-4% of adults. Although the     efficacy of medications for ADHD is well demonstrated in clinical trials, substantial numbers     of patients fail to remain on therapy, and there is tremendous variability in tolerability     and treatment acceptance. It is of great interest to identify biomarkers relating to     medication response in ADHD. However, the procedure for obtaining central markers such as PET     scan is invasive and expensive. Previous studies have found that mRNA expression of     neurochemical markers in circulating blood can reflect the neurochemical levels in the brain.     Further studies to identify peripheral biomarkers related to medication response in ADHD are     warranted.   "
92586|NCT02074215|"     Recent studies have shown that aerobic exercises and dual-task training are effective in     improving overall cognitive function in patients with cognitive impairment or dementia.     However, the biological mechanisms are unknown in humans. It also remains unclear regarding     whether carrying APOEε4 genotype or not would influence the effects. Therefore, the three     main purposes of this study are: (1) to investigate the effects of a 3-month aerobic     exercises combined with dual-task training on memory and executive cognitive functions in     patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease     (AD); (2) to compare the differences in training effects between patients who carry APOEε4     genotype and those who do not carry this genotype; and (3) to investigate the biological     mechanisms of the exercise training effects on memory and executive cognitive function in     these patients. The biological mechanisms of interest will include the blood Aβ1-40 and     Aβ1-42 level, insulin, fasting glucose, cytokine, integrity of brain fiber tracts, and     cerebral blood flow.      We will conduct a randomized controlled clinical trial. A total of 70 patients with MCI or AD     will be recruited. The participants will be randomly assigned to the experimental group or     the control group. Both groups will receive three 90-minute exercise sessions per week for 12     weeks. For the experimental group, the exercise program will include moderate intensity     aerobic exercises and dual-task training; whereas for the control group, the training program     will include gentle stretching exercises. Both groups will receive examinations on outcome     variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose,     cytokine,integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual     task performance at baseline, post-training, and after a 3-month follow-up period.     Differences on the aforementioned outcomes brought by the 12-week training programs will be     compared between the experimental and control groups. Exercise effects between patients who     carry APOEε4 genotype and those who do not will also be examined.      Results of this study will provide relevant clinical evidence for the effects of aerobic     exercises combined with dual-task training on patients with MCI and mild AD; and will provide     further understanding of the mechanisms mediating these effects.   "
92587|NCT02074202|"     Liver cancer is a major cause of death among patients of east or southeast asian descent, as     well as other population groups, notably in central and west Africa. Diagnosis of liver     cancer requires a combination of several imaging techniques and biopsies. Despite this,     diagnosis can remain inconclusive or difficult to establish in patients at risk for liver     cancer.      The purpose of this multi-center trial is to evaluate novel imaging methods developed to     diagnose the most common form of liver cancer, hepatocellular carcinoma. We propose to use     novel imaging probes that have been reported to bind to liver cancers but not benign liver     lesions that can be confused with liver cancer. Two such imaging probes will be evaluated.     2-[18F]-fluoro-2-deoxy-D-glucose, called [18F]FDG, is a radioactive sugar that is widely used     for cancer imaging with a device called positron emission tomography, or PET scans. We     already know that [18F]FDG cannot detect some liver cancers that are slow growing.     [18F]Fluorocholine ([18F]FCH), another molecule, has been recently reported to be highly     effective at detecting liver cancer. In 2010, a French researcher reported 80-90% detection     rate by using [18F]FCH alone or in combination with [18F]FDG.      We will compare [18F]FCH and [18F]FDG in evaluating 150 patients over a period of two years.     The results will be correlated with those of biopsies and clinical follow-up.      This study will provide valuable data on whether these imaging agents can successfully     differentiate malignant liver lesions from benign ones. It will also provide information     about whether these imaging agents can successfully assess whether the cancer has spread     outside the liver. It will provide data that will allow physicians to determine the optimal     imaging protocol to properly diagnose liver cancer.   "
92588|NCT02074189|"     Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for     locally advanced bladder cancer.   "
92602|NCT02074007|"     Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear     infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The     patient or caregiver will measure the amount of ear pain before and after the ear drops to     establish if the medicated ear drops decrease the amount of pain more than the placebo ear     drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be     used up to 4 days, as needed for ear pain.   "
93310|NCT02064712|"     The purpose of this study is to determine an optimal strategy to wean nasal continuous     positive airway pressure (NCPAP) in preterm babies. The investigators hypothesize that babies     that are taken off NCPAP at lower settings will need fewer total days on NCPAP than those     babies taken off at higher settings.   "
92589|NCT02074176|"     Background: Attention deficit hyperactivity disorder (ADHD) is an early onset, highly     heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on     individuals, families, and societies. It affects 7.5% of school-aged children in Taiwan.     Emerging evidence has suggested that patients with ADHD may present with a deficit of     attention, alertness and sleep disturbances. Since attention, alertness, and sleep     disturbances may significantly increase the functional impairment of ADHD, gaining insight     into their pathophysiology as well as into their treatment is of relevance to provide a     better clinical management of patients suffering from ADHD. The orexin system, located in the     hypothalamus, takes an important role in homeostatic functions, such as attention, alertness,     sleep-wake cycle, and feeding. To our best knowledge, the functioning of the orexin system     has never been investigated in patients with ADHD. Given the involvement of the orexin system     in the control of alertness and reward seeking, the present study aims to examine whether     plasma orexin and mRNA expression levels of pre-pro-orexin gene are associated with the     symptoms and neurocognitive deficits of ADHD.   "
92590|NCT02074163|"     Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are     typically injected. All nerves terminate on the fascia, where ASIS device can precisely     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse     reactions and distant spread, especially since Botox has no reason to travel to the rest of     the body any way.   "
92591|NCT02074150|"     Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are     typically injected. All nerves terminate on the fascia, where ASIS device can precisely     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse     reactions and distant spread, especially since Botox has no reason to travel to the rest of     the body any way.   "
92592|NCT02074137|"     Primary Objective:      To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone     refractory prostate cancer      Secondary Objectives:        1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for          the treatment of patients with metastatic Hormone Refractory Prostate Cancer        2. To describe patient profile in terms of demography, disease characteristics and prior          treatment history        3. To describe efficacy outcomes: radiological response (if available) using Recist          criteria V 1.1 and Prostate Specific Antigen (PSA) response   "
92593|NCT02074124|"     The aim of this study was to investigate changes in abdominal tissue perfusion during     adenosine vasodilation. Our hypotheses were that CT perfusion measurements are altered by     changes in the circulatory system mediated by adenosine, and a more differentiated assessment     of the circulatory capacity of abdominal tumours could be achieved by sequential rest and     adenosine vasodilation CT perfusion measurements.   "
92594|NCT02074111|"     The aim of this study is to investigate the proportion of patients with moyamoya disease     among the patients who were diagnosed as having intracranial atherosclerotic stroke. To do     this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography     are performed during follow up (in selected patients).   "
92595|NCT02074098|"     The purpose of this study is to determine whether a bed height make an effect to endotracheal     intubation with Macintosh laryngoscope, Glidescope and Airwayscope during chest compressions     in- hospital simulation cardiac arrest.   "
92596|NCT02074085|"     An ADE is defined as harm caused by a drug or the inappropriate use of a drug. Retrospective     record reviews in several countries have shown that anticoagulants frequently lead to     hospital readmissions. In this study a hospital readmission is defined as an admission to the     emergency department of the Jessa hospital. The objective of this study is to determine the     incidence of one week and 30-day readmissions caused by (preventable) ADE's due to     anticoagulants.   "
92597|NCT02074072|"     European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality     chest compressions .They propose minor changes for pregnant women: manual left deviation of     the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava.     We will examine the performance of the Glidescope (GVL), the Pentax-AWS Airwayscope(AWS) and     Macintosh laryngoscope (McL) for airway management during chest compressions on 15 and 30     degree left-lateral tilt (15 &30 LLT) custom-made hard wedges.   "
95216|NCT02039817|"     This is an open-label, parallel-group study to compare the pharmacokinetics and     pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with     severe renal impairment and matched healthy volunteers with normal renal function.   "
92599|NCT02074046|"     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors     into immunosuppressed mice, preventing an assessment on the immunologic interactions and     effects of CSCs. In this study, the investigators examined the vaccination effects produced     by CSC-enriched populations from histologically distinct murine tumors after their     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic     and more effective as an antigen source than unselected tumor cells in inducing protective     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor     immunity.   "
92600|NCT02074033|"     The infection is a major risk to hospitalized patients, especially those admitted to the     Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill     patients, increasing costs and prolonging hospitalization hospitalar. The     ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection     in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high     rate of PAV and mortality related to it, is very important both prescription and     administration of antibiotics correctly, as deescalation or escalation according the result     of cultures.Therefore, the objectives of this study is assess if whether the antibiotic     prescribed of ventilator-associated pneumonia following the orientation of literature. Will     also be assessed the rate of PAV in patients critically ill adults, the main microorganisms     responsible by PAV and determining antimicrobial susceptibility.   "
92603|NCT02073994|"     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,     pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma,     that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where     cohorts of patients will receive ascending oral doses of AG-120 to determine maximum     tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is     a dose expansion phase where four arms of patients will receive AG-120 to further evaluate     the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated     time on study treatment is until disease progression, unacceptable toxicity occurs or at     Investigator discretion.   "
92604|NCT02073981|"     This study is implemented to identify factors having an impact on improvement or exacerbation     of non-motor symptoms, to provide information contributing to development of medical care in     this field and improvement of patients' QOL, and to clarify the association between the use     of istradefylline and non-motor symptoms or QOL.   "
92605|NCT02073968|"     This phase II trial studies how well intensity modulated radiation therapy adjusted by     positron emission tomography (PET) scanning together with combination chemotherapy works in     treating patients with stage II-IV non-small cell lung cancer (NSCLC). Radiation therapy uses     high energy x rays to kill tumor cells. In intensity-modulated radiotherapy, multiple beam     angles and dozens of beam segments are used to deliver highly conformal radiation therapy.     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving PET-adjusted IMRT together with combination chemotherapy may kill more tumor     cells.   "
92606|NCT02073955|"     This is a validation study. A stroke symptom questionnaire will be adapted and translated     into local language. Two community health workers will be trained in its administration.     Their findings will be validated against assessment by two neurologists.      The study hypothesis is that the chance corrected agreement between the community worker     administered stroke symptom questionnaire and the assessment by neurologist based on history     and physical examination is at least moderate.   "
92607|NCT02073942|"     The wearable cardiac defibrillator (WCD) is an alternative to the implantation of     cardioverter defibrillator (ICD) for patients at high risk for sudden cardiac death (mostly     bridging therapy). The Cologne register of wearable defibrillator (CRWD) is a prospective     register for all patient with an indication of wearable defibrillator.   "
92608|NCT02073929|"     Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated     with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.      The study investigates the effect af intervention with GLP-1-analog on risk markers of     cardiovascular disease in women with PCOS.      70 women will be included in af RCT.      Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a     beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.   "
92676|NCT02073045|"     This pilot clinical trial studies intensive education in increasing understanding of     lymphedema in patients with breast cancer undergoing surgery. Lymphedema is the build-up of     fluids in the arm (or other extremity) after surgery. Providing written educational handouts     and verbal education on the risk factors and symptoms of lymphedema may improve patients'     ability to identify symptoms of lymphedema after surgery.   "
92677|NCT02073032|"     The main objective of this observational survey was to determine the incidence rate of     refeeding phenomena (RFF) (defined as any decline in p-phosphate) and RFS (defined as any     decline in p-phosphate with additional development of any of the following clinical symptoms:     oedema, confusion, dyspnoea, hypotension, arrhythmia, seizures) among recently admitted or     referred HNC patients to the Department of Otorhinolaryngology for surgery. The second     objective was to determine if informations at admittance could identify HNC patients at high     risk of developing RFF and RFS.   "
92609|NCT02073916|"     This open-label, single-center study will assess the safety and tolerability of combining     trastuzumab emtansine (T-DM1) to Lapatinib and Abraxane in patients with metastatic     HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and     T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Anticipated     time on study treatment is up to 12 weeks for patients metastatic breast cancer, until     disease progression or unacceptable toxicity occurs. Subjects may continue on treatment past     12 weeks if responding to study treatment.      The purpose of this study is to test the safety of Trastuzumab Emtansine in combination with     Abraxane and Lapatinib at different dose levels. The investigators are proposing in this     phase Ib study to assess the maximum tolerated dose (MTD) of Trastuzumab Emtansine in     combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.      The investigators hypothesize that combining antibody-drug conjugate trastuzumab-emtansine     and lapatinib together with Abraxane will improve clinical efficacy by affecting both PI3K     and ERK1,2 MAPK pathways.   "
92610|NCT02073903|"     The purpose of this study is to introduce new technology and interpreter practices in the     inpatient setting at MSKCC. We plan to install dual handset phones at the bedsides of limited     English proficiency (LEP) patients and to assess the impact on both patient and physician     communication effectiveness with this technology.   "
92611|NCT02073890|"     Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and     pattern of traumatic brain injury varies in developed and developing countries. Subarachnoid     haemorrhage refers to blood in subarachnoid space that lies between arachnoid and     piameninges, covering brain. It is often associated with concurrent intracranial injury     component. Individuals at higher risk for tSAH are those who are at higher risk for blunt     head trauma. This includes adolescents, low-income individuals, men, and individuals with a     history of substance abuse. The investigators present study aims to investigate prognostic     factors associated with the neurological outcome among patients of post traumatic SAH.   "
92634|NCT02073591|"     This is a prospective, open label, single arm, and observational and multicenter study to     assess the correlation between PEST and SCORAD scores in the management of AD with the     Ceradan® regimen.   "
92635|NCT02073578|"     This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be     recruited for this trial, with the intent to treat 20 patients.   "
92612|NCT02073877|"     The Bone-Anchored Hearing Aid (Baha) system consists of an implanted part and sound     processor. The system provides a hearing solution for a subgroup of patients who cannot     sufficiently profit from conventional hearing aids. Disadvantageous are its high rate (up to     40%) of associated peri-implant dermatitis. This research project is part of an attempt to     reduce the amount of peri-implant dermatitis. Besides an attempt of Holgers to identify the     skin flora in relation to infection around the abutment using a standard culture which     yielded limited and no clinically relevant results, little is known about the microbiome on     the abutment or its interaction with the commensal skin flora. Moreover, conventional     cultures are not very sensitive in identifying bacteria. In 2010, Budding et al. introduced     IS-pro. Is-pro is a novel 16S-23S rDNA interspace (IS)- region-based profiling method. This     technology was devised to enable high-throughput molecular fingerprinting of microbioma.     Since IS-pro is quick and relatively inexpensive, these environments can also be monitored     over time by repeating the test. This paves the way for researching the microbiome on the     abutment and it could enable clinically objective follow up of treatments in vivo using the     human as a host. This technique allows researchers to even discover unknown, previously     unidentified bacteria. Additionally, Scanning Electron Microscopy will be used to assess the     spatial distribution and composition of bacteria on the abutment. The first step, using these     techniques, is to determine the bacteria which inhabit the abutment also in relation to the     surrounding skin. Additionally, the relationship with skin-implant infections and the effect     of treatments will be monitored. Depending on these primary scientific results, a subsequent     study will be devised to study (experimental) treatments in a randomized, controlled fashion.      Objectives of the study:        1. To identify the bacterial flora on the abutment in a phylum/species classification.        2. To assess the relationships between the commensal skin flora and the flora on the          abutment and to study if clinical signs of peri-implant skin infection and subsequent          treatment are associated with a change in bacterial composition.        3. To assess if there exists a relationship between skin hygiene and the transient skin          flora.   "
92613|NCT02073864|"     A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter     Aortic Valve Replacement (TAVR)   "
92614|NCT02073851|"     Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands.     Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the     duration of the TAVR procedure.   "
92615|NCT02073838|"     This is a research study of ribavirin which will be given in combination with vismodegib     and/or decitabine. The purpose of this study is to see if patients respond to treatment when     ribavirin is given with vismodegib alone or in combination with decitabine.   "
92616|NCT02073825|"     The purpose of this study is to adapt and pilot-test a web-based intervention intended to     help concerned partners provide support to service members with alcohol misuse and to begin     development of a service member module based on service member's input.   "
92617|NCT02073812|"     RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014)     to treat bacterial infections, including those due to multi-drug resistant bacteria.   "
92618|NCT02073799|"     Recent literature indicated that postoperative storage symptoms after Photoselective     vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were     often reported and generally more common than after transurethral prostatectomy (TURP).     However, almost all literature focused on postoperative urgency or dysuria immediately after     PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms     in the postoperative period after PVP or HoLEP and data on predicting factors that influence     improvement in storage symptoms postoperatively. The aim of this study was to compare serial     changes of postoperative storage symptoms between PVP and HoLEP, and to identify the     predictors that influence improvement of storage symptoms postoperatively.   "
92619|NCT02073786|"     Lightwand is a useful alternative device for intubation but scooping movement can induce     damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is     rigid video stylet which has camera on distal tip of device. In many previous studies, rigid     video stylet has proven advantages compared with other intubating devices.   "
92620|NCT02073773|"     The present proposal aims to assess whether a combined rehabilitation approach using virtual     reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard     rehabilitative occupational therapy and physiotherapy will lead to signifcantly better     outcomes for stroke recovery.      It is a randomised controlled trial with blinding of the assessors only. It will be preceeded     by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only. Recruited     in-patient rehabilitation ward patients who have recently suffered stroke will be randomized,     through a computer-based random number generator, to either one of two treatment arms:        1. Control occupational therapy + pharmacotherapy for 2 weeks        2. Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks   "
92621|NCT02073760|"     The investigators will conduct qualitative interviews of hospital personnel regarding HAI     prevention practices, and use coded data from these interviews to assist in developing     standardized practices.   "
92625|NCT02073708|"     One out of ten adults and up to 20 % of children in Northern Europe are diagnosed with     asthma. Patients with onset of disease in childhood and patients with adult-onset asthma have     in common that their symptoms can be aggravated by exposures in the workplace. Work     exacerbated asthma (WEA) is defined as worsening of asthma due to conditions at work and is     common with a median prevalence of 22 %. However, additional research is needed to improve     the understanding of the risk factors, mechanisms and outcomes of WEA. Studies of difference     in response to exposures between subgroups of asthma patients may provide new insight also     into the phenotypic heterogeneity of asthma.      The primary aim of the study is to estimate the incidence rate of asthma in relation to age,     sex, socioeconomic factors and occupational exposures in a prospective study. Recently, data     on respiratory symptoms and physician diagnosed asthma has been collected from 16.300     inhabitants of Telemark County (baseline study). A random sample from the baseline sample of     1000 asthma cases and 1000 controls will be asked to participate in a medical examination in     which blood pressure, lung function and Fraction of exhaled nitric oxide (FeNO) will be     measured. In addition, blood samples will be collected form analysis of inflammatory markers     and gene sequencing. The case-control study will be repeated after five years and ten years,     if founded (5- and 10-year follow-up).   "
92636|NCT02073565|"     This is a multi-center, single-blind, randomized, active-controlled, clinical trial in     Percutaneous Coronary Intervention [PCI] subjects. Subjects will be randomized to receive the     Combo stent as the investigational treatment arm or an EES as the active-control arm.   "
92637|NCT02073552|"     The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus     ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume     polyethylene glycol preparation in subjects with past history of poor bowel preparation   "
92626|NCT02073695|"     Research question:      Do patients using a neutral rotation brace post surgery have improved functional outcome and     external rotation of the shoulder compared to current best practice using a polysling holding     the proximal humerus in internal rotation?      Primary objectives:      To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months     and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks     and 1 year) between patients held in neutral versus current standard rotation. These will be     compared to scores taken pre-operatively.      Benefits:      There may be no extra benefits to patients from this trial however the results from the trial     will help improve treatment for future patients at this hospital, and others across the     country.      Risks/disadvantages:      The operation is the same in both groups studied, the study is investigating the use of the     two different slings. The post-operative treatment is also the same, and all patients on the     trial will receive the same amount of physiotherapy. It isn't anticipated that there will be     any additional risk from this trial.   "
92627|NCT02073682|"     Edoxaban will be similar to dalteparin in preventing recurrence of acute VTE following an     initial index event in cancer subjects.   "
92628|NCT02073669|"     The aim of study is to evaluate the prevalence of latent TB in second generation immigrants     from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the     control native Israelis without a family member who was born in a country with high incidence     of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators     expect that the second generation immigrants group will have more positive IGRA test than the     control native group.   "
92629|NCT02073656|"     This study will evaluate the antiviral efficacy, safety, and tolerability of     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in     hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment     intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with     HIV-1.      Participants who experience confirmed post-treatment virologic failure (relapse) at or before     Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive     LDV/SOF plus ribavirin (RBV) for 24 weeks.   "
92630|NCT02073643|"     This project examines behavioral and household characteristics associated with food     purchasing patterns.   "
92631|NCT02073630|"     Dystonia, a disabling disease with uncontrolled movement disorders was considered to be a     manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal     and human experiments that the cerebellum plays a prominent role in the pathophysiology of     dystonia. Our recent results suggest a deficient cerebellar sensory encoding in dystonia,     resulting in a decoupling of the motor component from the afferent information flow resulting     from changes in the environment. An overall loss of gabaergic-mediated inhibition is at the     forefront in dynamic changes in neural circuitry described in dystonia. In the mature brain     gabaergic control the generation of temporal synchronies and oscillations in the     glutamatergic neurons. Taken these all together with the results of a pilot experiment, the     investigators hypothesize that deficient synchronies in the fast gamma range are one of the     key mechanisms leading to abnormal communication inside the cerebello-cortical network in     dystonia. The investigators aim first to demonstrate it by means of MEG (Magneto     encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma     oscillations in the nodes of the cerebello-cortical network. The investigators then aim to     re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the     cerebellum at high gamma frequency a non invasive transcranial alternative current     stimulation.   "
92632|NCT02073617|"     The American College of Cardiology/American Heart Association guidelines place symptomatic     severe Aortic Stenosis as a class I indication for aortic valve replacement. With the     recently approved Edwards-Sapien TAVR device and the ongoing investigations using the     CoreValve TAVR device, patients ineligible or at high risk for open-heart surgery are now     eligible to undergo TAVR.      Patients selected for TAVR undergo an EKG-gated cardiac Multislice CTA to evaluate aortic     valve anatomy and aortic root dimensions for device sizing, as well as coronary angiography     to define coronary anatomy. Both tests utilize contrast media to visualize anatomy, which may     result in contrast-induced nephropathy in anywhere from 7.5% to more than 50% of patients     depending on associated clinical risk factors.      There is a need to consolidate this pre-operative testing whenever possible, and with     real-time 3-dimensional visualization of aortic valve and root anatomy using DynaCT cardiac     acquisition in the cath lab angiography suite during the coronary angiography, there may be a     benefit with reduced contrast load (20 to 35cc for DynaCT, 100cc for CTA).      We would like to make a comparison of aortic valve and root measurements using CTA and DynaCT     to affirm the accuracy of DynaCT vs the CTA gold standard.   "
92678|NCT02073019|"     The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in     the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers   "
95313|NCT02038556|"     The purpose of this pilot study is to evaluate our RN CBT-I program outcomes and determine     utility of this program as a high-value care model targeted specifically to our sleep center     patient population.      Hypothesis: PIRS will improve from baseline to 2 month follow up   "
92633|NCT02073604|"     The aim of the project is to study the role of secondary motor area (more precisely the     supplementary motor area, or SMA) during unimanual and bimanual voluntary movements     externally (cue) or internally (subject's choice) triggered. In that view, we will study 3     experimental groups :        -  a group of healthy volunteers (control group)        -  the same group of healthy volunteers after a transient inactivation of the SMA (by the          aim of repetitive trans cranial magnetic stimulation or TMS)        -  a group of patients suffering from congenital mirror movements who are suspected to          present a dysfunction of the SMA (according to our previous results) In each of these          groups, by the aim of a serial reaction time task, we will study the influence of a SMA          stimulation on the excitability of the primary motor cortex (M1) during the preparation          of a voluntary movement (unimanual or bimanual). This will allow us to assess the          communication between the SMA and M1 during movement preparation. Using the same task in          functional imagery, we will study the activation's pattern of primary and secondary          motor areas during movement preparation. This multimodal approach should allow us to          better understand the synergistic functioning of these different structures involved in          movement preparation. An other interesting aspect will be to determine the role of these          structures in movement lateralization. Eventually, our results might allow us to precise          to role of the motor preparation's dysfunction in the genesis of congenital mirror          movements.      In the first place, this study aims at a better understanding of the cerebral physiology of     movement preparation (which is not well known) using the mirror movements paradigm as a     dysfunction model (according to our previous results). According to our hypothesis, there is     a strong link between the SMA and M1 during movement preparation. This hypothesis will be     assessed by the use of the same experimental task with combined neurophysiological and     neuroimaging approaches, thus increasing the validity of the results obtained.      A secondary aim of this protocol is to precise the role of motor planning dysfunction in     patients with congenital mirror movements. A better understanding of the mechanisms     responsible for this condition is necessary in a medium-term therapeutic prospect.   "
92638|NCT02073539|"     Chest compression (CC) feedback devices are used to perform CC measurements effectively and     accurately on patients in hospital beds. However, these devices do not take account of the     compression of the mattress, which results in overestimation of CC depth. This study is the     validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful to     overcome this limitation and thus measure compression depth more accurately when performing     cardiopulmonary resuscitation (CPR) on patients.   "
92639|NCT02073526|"     Drug serum concentrations will be measured at several time-points for inflammatory disease     patients treated with anti-TNF agents. The purpose is to determine which patients that will     clinically benefit from either discontinue treatment, adjusting the dose, switch to another     anti-TNF agent or a different class of medication.   "
92640|NCT02073513|"     BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in     the children with cerebral palsy who have spasticity in their hands.      OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and     without pressure on hand function in children with cerebral palsy. METHOD: 45 children were     randomly allocated to one of the thenar taping groups either with or without pressure or to     the control group. Nine hole peg test and nine parts puzzle test were used to measure hand     function. The two study groups were evaluated initially, with taping 20 minutes later and 20     minutes after taping was removed.   "
92641|NCT02073500|"     The aim of this study is to identify biomarkers of disease recurrence and prognosis to     optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic     intraperitoneal chemotherapy (HIPEC), and through animal models to explore different     treatment strategies for peritoneal surface malignancies (PSM).   "
92642|NCT02073487|"     Purpose: The purpose of this study is to evaluate the Pathological Complete Response (pCR) of     the breast when trastuzumab emtansine (TDM-1) plus Lapatinib plus Abraxane is combined in     newly diagnosed HER2 positive breast cancer.      This is a randomized, open label Phase II neo-adjuvant study comparing the efficacy of     neoadjuvant Trastuzumab Emtansine (TDM1) plus lapatinib follow by Abraxane, versus     trastuzumab (herceptin) plus Pertuzumab follow by paclitaxel.   "
92643|NCT02073474|"     The purpose of this registry is to monitor safety outcomes of patients who are receiving     Sativex® for Multiple Sclerosis (MS) spasticity and for off-label indications in the United     Kingdom (UK), Germany and Sweden.   "
92644|NCT02073461|"     This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%)     versus vehicle in the treatment of acne vulgaris in the Japanese patients.   "
92645|NCT02073448|"     This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of     CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the     treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.   "
92646|NCT02073435|"     Living donor liver transplantation (LDLT), involves complex systems and processes of care     that are particularly vulnerable to medical errors and preventable complications. This     ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will     focus on conducting a proactive, systematic, and comprehensive assessment of the     vulnerabilities in the systems and process of LDLT care to reduce medical errors and     preventable complications thereby improving the safety of LDLT care. This project will     address an important gap in the knowledge needed to achieve high quality and safe LDLT care     of patients by developing a process to: 1) proactively, systematically and comprehensively     identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design     and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of     these solutions to improve the safety of LDLT care by measuring clinical and process outcomes     before and after solution implementation across four A2ALL participating transplant centers   "
92710|NCT02072603|"     The purpose of this study is to determine the effectiveness of the HITSystem in maximizing     early infant diagnosis (EID) service utilization for HIV-exposed infants and early     antiretroviral therapy (ART) initiation for infants diagnosed with HIV.   "
92711|NCT02072590|"     The main purpose of this study is to improve the diagnostics of celiac disease and reduce the     need for invasive endoscopic studies in children. Further, the investigators aim to     investigate the natural history and risk of complications in children with celiac disease or     gluten sensitivity and to create a large scientific database.   "
92647|NCT02073422|"     BACKGROUND: Non-ST-segment elevation myocardial infarction (NSTEMI) is the commonest type of     acute coronary syndrome (ACS) and has a poor long-term prognosis. Guidewire-based coronary     pressure measurement of the myocardial fractional flow reserve (FFR) is validated for     measuring the severity of a coronary lesion narrowing in patients with stable angina. FFR     measurement in patients with a recent ACS has theoretical limitations and is not fully     validated.      AIM: To prospectively assess heart muscle blood flow and injury with guide-wire based methods     at the time of the clinically-indicated angiogram and compare these results with those from a     stress perfusion MRI scan in medically-stabilised NSTEMI..      HYPOTHESIS: 1) FFR measured invasively will correspond closely with findings from stress     perfusion MRI, 2) MRI will provide clinically-relevant information on heart muscle injury,     function and salvage, 3) Guidewire-derived measurements of coronary microvascular function     will be associated with the MRI findings.      DESIGN: The MRI study will be performed in patients who give informed consent in the     FAMOUS-NSTEMI clinical trial (NCT registration 01764334). All of the clinical data for these     participants will be available to link with the MRI results.   "
92648|NCT02073409|"     Isolation of an nontuberculous mycobacteria (NTM) from sputa of cystic fibrosis (CF) patients     is relatively common, and of uncertain significance. At the request of the CF Foundation     (CFF), the Investigators have designed a standardized diagnostic protocol based on current     recommendations for the diagnosis of NTM by the American Thoracic Society, as well as     forthcoming recommendations by the CFF and the European CF Society. The study is     observational in nature, and is not intended to change the current diagnostic approach to the     infection, but rather standardized the collection of data to facilitate the decision making     process. When validated, this protocol will be easily assessable to the entire CFF Care     Center Network.   "
92718|NCT02072499|"     The purpose of this study is to compare safety and efficacy of Green Light PVP     (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating     benign prostatic hyperplasia (BPH).   "
92649|NCT02073396|"     Patients with coronary artery disease (CAD) and atrial fibrillation (AF) are at increased     risk of stroke and heart attack. Such events are usually caused by increased stickiness of     the blood causing a blood clot to block the artery (thrombus) in the heart or the brain. The     aim of this study is to assess the stickiness of the blood (global thrombotic status) in     patients with CAD and AF at baseline and after clinical stabilisation to see how disease     state and clinical treatments affect the stickiness of the blood (thrombotic status). This     will be a single centre study. Patients diagnosed with CAD or AF will have a blood sample     taken at baseline and after clinical stabilisation. Blood stickiness will be tested with the     Global Thrombosis Test. The results will be evaluated to assess the effect of disease process     and clinical state on blood stickiness to gain further understanding of this condition and     form the basis for future studies aimed at identifying patients who are at high risk of     future cardiovascular events, based on increased blood stickiness.   "
92650|NCT02073383|"     The brachial plexus block is an anesthetic technique often used for surgical procedures of     the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques     most commonly used to obtain regional anesthesia of the upper limbs, being performed by     anesthesia of the terminal branches of the brachial plexus, which would be the ulnar, median,     radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can be used     to perform the BPVA . The first , known as multiple puncture technique , the local anesthetic     is deposited around each nerve that want to block . This technique is most commonly used to     perform the BPVA . The second technique , known as 2 injections , local anesthetic is     deposited below the axillary artery and around the musculocutaneous nerve . This technique     has been proposed to try to reduce the execution time of anesthesia . Studies actually show     that the technique of 2 injections showed less time to perform the block, with the same     success rate. However, the technique of 2 injections showed a longer latency and higher rate     of vascular puncture . (14) In order to perform a procedure with shorter execution time ,     without changing the latency, success rate and ensuring patient safety , the investigators     designed this protocol to evaluate three techniques for performing the ultrasound- guided     axillary brachial plexus block.   "
92651|NCT02073370|"     Sarcopenia related mobility dysfunction was a preventable presentation in transitional     variation of frailty. However, the definition, associated risk factors, clinical course and     outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for     further study.   "
92652|NCT02073357|"     General anaesthesia is a reversible drug-induced coma. Too little can result in patients     being partially conscious during surgery; too much can slow recovery after surgery. There is     a range of drug doses that can be used and some anesthesiologists use more than others. There     is no convincing evidence that any particular dose within the usual range is better.     Consequently, there are no guidelines on the best depth of anaesthesia. This study will     determine whether general anesthetic concentrations at the low end of the usual range are     better than those at the high end.      Participants will randomly be assigned to lighter or deeper general anesthesia. The first day     after surgery, two short questionnaires about recovery and memories of the surgery will be     completed. During the rest of the participant's hospital stay, a survey about how one feels     will be completed.      There will be two telephone contacts after discharge from the hospital. One month after     surgery three questionnaires will be completed about performing daily tasks, how you feel and     memories of the surgery. Then one year after surgery pain will be assessed.   "
92653|NCT02073344|"     The purpose of this study is to investigate the effect of beginning a renal replacement     therapy on fluid overload and its consequence on the severity of obstructive sleep apnea, in     patients with end stage chronic kidney disease. It aims further to investigate the     relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep     apnea.   "
92654|NCT02073331|"     The objective of the study is to actively gather additional information on the use of     CorMatrix ECM for pericardial reconstruction.   "
92655|NCT02073318|"     Purpose -To investigate whether older adults with dementia who have balance and gait problems     can improve their balance and gait function after an individualized 4-week tasks-oriented     balance training with sensory manipulation.      Hypothesis      -There is significant difference of Timed Up and Go Test, Berg Balance Scale, walking speed,     30-s chair-stand test, Chair sit-and-reach test and Barthel Index between dementia patients     who received tasks-oriented balance training and those didn't receive after 4-weeks training     and one month follow-up.   "
92657|NCT02073292|"     Nerves in your body transmit signals to and from your brain and the cells in your body. In     the event of an injury or disease, these nerves transmit pain. Sometimes, when an injury     doesn't heal, chronic pain can develop. One way to treat chronic pain is to interrupt these     pain signals. One method of doing this is to use Radio frequency ablation (RFA).      Radio frequency ablation (RFA) is a medical procedure in which heat is generated from high     frequency electrical current in order to lesion (burn) nervous tissue. Radiofrequency     ablation is used to treat many conditions in several areas of the body including cardiac     (heart) as well as chronic pain. Probes (needles) are inserted into the body to a specific     location and the electrical current is passed through these needles. This electrical current     creates heat in your body and forms small lesions or burns in a specific place. Doctors will     use tools, such as fluoroscopy (x-rays) and injections to locate the specific nerves that are     transmitting pain and then use the electrical current to destroy those nerves.      Equipment used include generator, built in nerve stimulator, different needles and probes and     water cooling system in case of the cooled RFA.      There are several types of probes or needles that are used to transmit energy and create     lesions. This study is going to compare 2 types - standard radiofrequency and 'cooled'     radiofrequency. The only difference is that the 'cooled' radiofrequency probes have water     running through the probe tip, which keeps the tip cool and allows a larger lesion to be     made. Since the doctor can't actually see the nerve he is trying to target, the larger lesion     should theoretically improve his chances of hitting it. The 'cooling' of the water also     allows the temperatures to be lower than what is needed for standard RF. In this study, the     investigators would like to compare the differences between standard RFA (90°C) and cooled     RFA (60°C) ablation techniques and determine if one is better for pain relief.      All of the probes that are used to perform radiofrequency ablation are FDA approved and are     commonly used to treat patients with chronic back pain.      Participating in the study involves being randomly assigned to received either standard or     cooled RFA. The procedure for both standard and cooled RFA is basically the same. The only     difference is with standard RFA, the doctor may perform up to 2 lesions, instead of 1 if they     are using cooled RFA.      Both study groups will receive local anesthetic prior to procedure. The treating doctor will     use a machine called a C-Arm to take x-rays. These x-rays will guide the doctor to be sure     the probes are in the right place. Once the probe placement is confirmed, the doctor will     turn on the generator and create the lesion. This process will be repeated depending on how     many lesions need to be created.      After the procedure there will be follow up visits at 1, 3 and 6 months. Level of pain,     health and recovery information will be collected.   "
92658|NCT02073279|"     The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,     pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD   "
96915|NCT02017639|"     Primary Objective:      To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the     pharmacokinetics of simvastatin in patients with rheumatoid arthritis      Secondary Objective:      To describe the safety and efficacy (exploratory) of sarilumab   "
92659|NCT02073266|"     The primary purpose of the study was to compare the macular hole closure and visual acuity     gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning versus     C3F8 gas tamponade with 14 days of face-down positioning.      The secondary purpose was to report, in each group, the cumulative incidence of cataract     development 1 year following macular hole surgery and the proportion of complications (*).      ((*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) This     prospective randomized study examined a 3 year period. The first patient was included in     January 2010 and the last in November 2011. The 12-month follow-up spread out from March 2011     to December 2012. The first group included 31 patients who had undergone macular hole surgery     using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively     (SF6 group). These patients were compared to 28 patients who had undergone macular hole     surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days.     Patients in both groups underwent vitrectomy, internal limiting membrane peeling, and     fluid-gas exchange using either SF6 or C3F8.      Preoperative data included the characterization of the hole with Optical Coherence Tomography     (OCT), the best correct visual acuity (VA) recorded in number of letters using the Early     Treatment Diabetic Retinopathy Study (ETDRS) chart, classification of the cataract according     to the LOCS III and the intraocular pressure IOP. Postoperative data included OCT     confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected VA recorded in     number of letters (EDTRS chart) and determination of cataract development and extraction as     needed.   "
92660|NCT02073253|"     Introduction: Noninvasive ventilation (NIV) has been used to minimize such impairment and     increasing ventilator reserve in individuals with heart failure. Aim: To analyze     thoracoabdominal kinematics (TK) in individuals with HF associated to cardiomegaly after     using NIV. Methods: A randomized crossover clinical trial with allocation consisted of two     experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30     minutes of bi-level ventilation was performed. Any type of ventilator support was offered     during control phase. Optoeletronic plethismography was performed to asses TK.   "
92661|NCT02073240|"     Study Design: Stratified, matched, cluster-randomized, controlled trial      Unit of Randomization: Healthcare facility      Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare     workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among     susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0     (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and     disseminated.      Study Components: Assessment of institutional safety culture; observations/audits of     Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices;     documentation of time intervals for processing sputum smears and initiation of TB treatment;     facility assessments; random allocation and implementation of enhanced Tuberculosis infection     control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost     evaluation of intervention.      Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will     allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the     intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control     group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per     cluster with 50% LTBI prevalence at baseline).   "
92662|NCT02073227|"     The purpose of this study is to assess the bioequivalence of the fixed dose combination (two     components combined in one tablet) of canagliflozin and metformin extended release (XR)     tablet (dose of 2 X 150 mg/1,000 mg) with respect to the individual components of     canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.   "
92663|NCT02073214|"     The purpose of this study was to evaluate the safety of a probiotic foodstuff and its     influence on emergence and development of natural intestinal flora and the clinical status of     premature very low birth weight neonates. The study was also intended to investigate     reduction of colonisation by pathogenic bacteria and to estimate the incidence of     gastrointestinal disorders.      Probotic bacteria contained in the investigational product administered directly after birth     are beneficial for the development of normal gut microflora and can prevent or significantly     limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic     flora in a hospital setting. Permanent colonisation with commensal flora in very early life     improves gastrointestinal function in premature neonates by reducing the onset of or by     decreasing the severity of the signs and symptoms of feeding intolerance and generalised     bacterial infections, including sepsis and necrotizing enterocolitis.   "
92664|NCT02073201|"     A primary focus of the University of Florida (UF) Claude D. Pepper Older Americans     Independence Center (OAIC) is to build a comprehensive understanding of the causes and     consequences of declining physical function and disability development among older adults. To     date investigators have largely focused on sarcopenia, the age-related decline in skeletal     muscle mass and strength, as the primary contributor to physical decline. However, recent     findings indicate that changes in the central and/or peripheral nervous systems may play a     larger role than previously thought in the development of functional limitations. These     fields hold extensive promise for identifying novel contributors to age-related functional     decline. Therefore, the overarching aim of this project is to develop the ability of RC1 to     assess novel neural contributors to mobility and overall physical function. Importantly, the     development of these techniques will provide the RC1 with the tools to evaluate the potential     involvement of the central and peripheral nervous systems in age-related functional decline     and disablement. The primary aim of this project is to develop techniques for quantifying     peripheral motor unit number and size as well as spinal cord integrity.   "
92665|NCT02073188|"     The purpose of this study is to demonstrate the superiority of iBGstar as a component of the     diabetes treatment vs. traditional blood glucose self-monitoring system for improving     glycemic control after 6 months in young patients with type 1 diabetes. The study is intended     also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs.     usual blood glucose self-monitoring system for improving the compliance to self monitoring of     blood glucose after 6 months.   "
92666|NCT02073175|"     The purpose of this study is to determine whether a dietary supplement (DS) is effective in     protecting against sad mood in postpartum.   "
92667|NCT02073162|"     Physicians differ in their approaches to surgical fluid therapy, with some preferring higher     volumes and others lower volumes. Each approach has potential advantages and disadvantages.     Currently, there is no compelling evidence that one approach is better than the other. This     study tests whether giving a volume on the low end of the usual amount (restrictive     management) has a different rate of complications compared to a volume on the high end of     the usual amount (liberal management). This study will compare liberal and restrictive     fluid management to determine their effects on major complications after abdominal surgery.      Those who take part in the study will be visited five times before and after surgery in the     hospital. Once discharged from the hospital, participants will be called 4 times on the     telephone.      Preadmission Clinic/Preoperative Visit        -  Sign the consent document        -  Have blood drawn for standard preoperative tests (standard of care)        -  Have an electrocardiogram (standard of care)        -  Complete a questionnaire on disability (research)      Day of Surgery        -  Have blood drawn if not already done during the first visit (standard of care)        -  Have an electrocardiogram if not already done during the first visit (standard of care)        -  Be randomly assigned to either restrictive or liberal fluid management (research)      Post-op Day 1        -  Have an electrocardiogram done (research)        -  Have blood drawn for standard tests (standard of care)        -  Have a wound inspection, if there is a change of dressing (standard of care)        -  Complete a questionnaire about your recovery (research)      Post-op Day 3        -  Have blood drawn for standard tests (standard of care) and c-reactive protein, which can          indicate infection (for research).        -  Have a wound inspection, if there is a change of dressing (standard of care)        -  Complete a questionnaire about your recovery (research)      Day of Discharge        -  Have a wound inspection, if there is a change of dressing (standard of care)           30-Day Follow-up Phone Call        -  Complete a questionnaire about your recovery (research)        -  Complete a questionnaire about disability (research)           3 Month, 6-Month, and 12-Month Follow-up Phone Calls        -  Complete a questionnaire about disability (research)   "
92668|NCT02073149|"     This study will determine whether the haemoglobin response to daily home fortification for 30     days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous     fumarate.   "
92669|NCT02073136|"     Patients with chronic kidney disease struggle to eliminate phosphate as the renal function     deteriorates, which results in accumulation of phosphate in the body. This has been shown to     increase the patients' risk of cardiovascular disease and death. Even with dialysis treatment     the patients cannot excrete enough phosphate to reach phosphate balance. The patients are     therefore recommended a very restrictive diet when they reach the dialysis stage. It is     therefore important to find ways to prevent such accumulation of phosphate in the body as     early in the disease process as possible, but without compromising the nutritional status.     Because phosphate occurs naturally in many of our foods, such as meat, fish and dairy     products, it is difficult to reduce the intake of phosphate, without also reducing the intake     of energy and protein. Over the past couple of years there has been an increased focus on the     use of phosphate containing additives in the food industry. A reduction in the intake of     phosphorus containing additives may reduce the accumulation of phosphate in the body. This     can be achieved by decreasing the intake of processed food products. Because it is also very     time consuming and inconvenient for the patient to keep these strict diets, the patients have     a reasonable claim to know which effects can be achieved by such diets. This will therefore     seek to be further explored in the following study. The study is conducted as a randomised     crossover trial in predialysis patients stage 3-4.   "
92670|NCT02073123|"     To evaluate the preliminary efficacy of the established dose of indoximod in combination with     immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete     response (CR) + partial response (PR))across both standard of care agents administered     sequentially in patients with unresectable stage III or stage IV melanoma   "
92671|NCT02073110|"     Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal     pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM)     that are incidentally discovered by abdominal radiological imaging. However, 30% of resected     SRMs appear benign on histological examination. Conventional biopsy is currently used to     provide pathological information prior to resection. However, its non-diagnostic value is     high, up to 33% in SRMs, showing the need for diagnostic improvement.      The investigators have shown that optical biopsy (OB) can differentiate malignant from benign     tissue and tumor subtypes. However, translation to the clinic requires a phase 2 clinical     study. The investigators will use an OB probe that can be combined with a needle puncture     during classical biopsy procedures, additionally providing real time micro-scale images     containing quantitative information about tissue properties. The investigators are convinced     that OB will greatly improve the diagnosis of renal tumor pathology.   "
92672|NCT02073097|"     This phase I/II trial studies the side effects and best dose of carfilzomib when given     together with rituximab and combination chemotherapy and to see how well they work in     treating patients with diffuse large B-cell lymphoma. Carfilzomib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,     such as rituximab, can block cancer growth by finding cancer cells and helping kill them.     Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. It is not known if carfilzomib in     combination with R-CHOP is better or worse than R-CHOP alone in treating patients with     diffuse large b-cell lymphoma.   "
92673|NCT02073084|"     The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus     on cardiac repolarization compared with placebo in healthy adult subjects.   "
92674|NCT02073071|"     This is a two stage open-label, single-arm, multicenter and observational study.   "
92679|NCT02073006|"     Constipation is common in the general population, especially in women and in the elderly.     Hard stool is a complaint often associated with constipation, which suggests that stool     softening would provide a major benefit in the strategy of treatment.      This investigative fibre product is primarily a soluble dietary fibre with added probiotics     and a prebiotic. It is not digested in the small intestine and partly remains undigested by     bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora,     reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the     improvement of intestinal motility.      The objective of this study is to assess if this investigative, fibre product effects the     number of bowel movements per week and if this in turn impacts quality of life and symptoms     of constipation.   "
92680|NCT02072993|"     This is a first time in human study to assess the safety and tolerability of AZD1979     following oral administration of single ascending doses in healthy male volunteers.     Pharmacokinetics (what the body does to the drug) parameters will also be assessed as     secondary objectives.   "
92681|NCT02072980|"     The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1®     (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.   "
92682|NCT02072967|"     Prospective multicenter observational non-interventional study to assess routine clinical     practice of Bendamustine use in the second line therapy of relapsed or refractory indolent     B-cell non-Hodgkin's lymphoma   "
92683|NCT02072954|"     To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg     manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10     mg.   "
92684|NCT02072941|"     In partnership with patients, caregivers, advocacy groups and clinicians, the investigators     plan to:      Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking     Latinos and stakeholders.      Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a     previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:      2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and     discuss wishes with surrogates and clinicians and complete ADs) measured by self-report,     chart review, surrogate reports, and      2b. Direct observation.      2c. Improve self-efficacy and satisfaction with medical decision making.      2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and     clinician-patient language concordance.      Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.   "
92685|NCT02072928|"     This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in     patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal     injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical     practice.   "
92686|NCT02072915|"     To compare the number of passes required for cellblock acquisition with and without suction     using the 25g needle.   "
92687|NCT02072902|"     This is a large nationwide population study, with 10 year follow-up, of the effect of     diabetes, metabolic control and a large number of glucose-lowering medications, on total and     site-specific cancer incidence and survival.      The study is based on electronic medical records from the largest Israeli health maintenance     organization in Israel, Clalit Health Services. 2,301,990 insurees age 21 years old or above     at study entry, January 2002 will be included. Four study groups will be established     according to the prevalence of diabetes and/or cancer on that date: neither diabetes nor     cancer; prevalent diabetes but not cancer; prevalent cancer but not diabetes; both diabetes     and cancer prevalence. Subjects free of diabetes at study entry will be followed for diabetes     incidence, and all four groups will be followed until December 2012 for study outcomes. The     cohort data file will be linked to the Israel National Cancer Registry for cancer morbidity.      We will compare, after adjustment, all and site-specific cancer rates between individuals     with and without diabetes; and investigate if metabolic control, as indicated by HbA1c and     blood glucose levels, is related to cancer risk. Using time-dependent Cox proportionate     hazard models, we will then evaluate differences in outcomes that associate with the use of     one or a combination of glucose-lowering treatments, while stratifying by those who were     already diagnosed with diabetes at study entry, and those diagnosed during follow-up. Data     for a large number of potential confounding variables, including BMI, plasma glucose, HbA1c,     hormone replacement therapy and comorbidities will help mitigate allocation bias. The     accessibility and uniformity of the healthcare provided by Clalit Health Services, as well as     data on cancer screening tests, will minimize the risk of surveillance bias.   "
92688|NCT02072889|"     Measurements will be made between the internal jugular vein and the carotid artery using an     ultrasound machine as the subjects is asked to move and position his or her neck in various     positions.      It is hypothesized that by movements of the neck the investigators can maximize the distance     between the internal jugular vein and the carotid artery to decrease inadvertent cannulation     of the carotid artery to improve patient safety   "
92689|NCT02072876|"     The incidence of stroke has increased by 100% in the last four decades in developing     countries like Pakistan. Intracranial atherosclerotic disease (ICAD) is the most frequent     causative subtype of ischemic stroke in the world including Pakistan. ICAD is progressive     narrowing of the arteries at the base of the brain due to atherosclerosis. After a stroke     from ICAD, recurrence rate is highest in any sub-type of stroke, up to 28% with limited     therapeutic options. Therefore, it is imperative to delineate the determinants of     asymptomatic ICAD prior to stroke. Investigators hypothesized that there is at least a 20%     difference in the proportion of clinical, life-style (dietary, physical activity, obesity,     smoking and stress/depression), and socio-economic predictors of asymptomatic ICAD than those     with no ICAD.   "
92690|NCT02072863|"     The purpose of Phase 1b of the study is to determine the maximum tolerated dose (MTD) of     oprozomib in combination with melphalan and prednisone (OMP).      The purpose of Phase 2 of the study is to estimate the overall response rate (ORR) and     complete response rate (CRR) of the OMP combination.   "
92712|NCT02072577|"     Supervise dental conditions and teach the procedure of oral hygiene are the responsibility of     the nurse. Patients on chemotherapy have risk for oral and systemic changes factors. The     investigators will evaluate the cognitive and procedural knowledge about oral hygiene and the     relevance of the learning experience importance.   "
92691|NCT02072850|"     Heart imaging with magnetic resonance imaging (MRI) provides detailed insights into heart     function and injury. The nature and significance of heart injury after a heart attack is     incompletely understood. We propose a 'natural history' study of heart attack injury using     contemporary MRI methods. In a large hospital in the West of Scotland, heart attack patients     will be invited to have at least two MRI scans and also continue with life-long follow-up.     The results from the MRI scans will be assessed with all of the other clinical information     obtained at the time of the heart attack and during follow-up. The results of our study     should provide new insights into heart attack injury and these results should help improve     how heart attack patients should be treated.   "
92692|NCT02072837|"     In this study, we studied lipoprotein abnormalities-related variables as risk factors for the     development of cardiovascular disease in patients on renal replacement therapies.We studied     96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24 healthy     controls.We concluded that metabolic acidosis activating the inflammation and lipoprotein     oxidation influences the dyslipidemia and cardiovascular morbidity of patients on renal     replacement therapies.Dialysis adequacy was positively associated to cardioprotective     HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized lipids than     hemodialysis modalities.   "
92693|NCT02072824|"     This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce     seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with     refractory partial onset seizures. It is hypothesized that both doses of pregabalin will     demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure     frequency and that pregabalin will be safe and well tolerated.   "
92694|NCT02072811|"     In view of the diversity of the biology of acute myeloid leukemia (AML) therapy in individual     patients must be individualized. One of the tools for this is molecular-cytogenetic     stratification. It divides patients into five categories (prognostic groups): Favorable,     Intermediate-1, Intermediate-2, Adverse and Very adverse risk. After remission proceedings     are tailored depending on prognostic determined groups.      Research of PALG group in the application in the second line regimen CLAG and CLAG-M proved     high effectiveness of this treatment with low toxicity. Considering experience of PALG     groups, it seems that the use of the schema CLAG early as the second induction therapy is a     viable treatment option.   "
92695|NCT02072798|"     Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum     infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS     infections is 7-10%. The most common infections are endometritis, Urinary tract infections     (UTI) and wound infections (WI).      Prophylactic antibiotics are effective in preventing postoperative infections and national     guidelines recommend that antibiotics should be administered as a single dose immediately     before surgical incision. CS is an exception to this pre-incision administration approach.     National guidelines recommend administration of antibiotics after umbilical cord clamping to     avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic     prophylaxis for CS suggest that prophylactic antibiotics administered before incision     compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two     Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on     the baby and on late infection in the mother.      At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and     simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation     of the digestive and immune functions to avoid gut disorders and infections. Full-term,     breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene     levels, antibiotics treatment and formula feeding may inhibit immune development both short     and long term. Birth by caesarean section in high-hygiene hospital environments, and     widespread use of antibiotics, are factors that reduce gut microbiota density and diversity     in the newborn for some time after birth. On the other hand, high-hygiene environments and     antibiotics are essential tools to combat infections, especially for the weakest newborn     infants.      This pilot study will be a feasibility study to the original study, which examines the effect     of change in timing of prophylactic antibiotics on the rate of post-CS infections     (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut     microbiota of newborn infants. The feasibility study will only include pregnant women in     Odense with a body mass index below 30, and planned cesarean section.   "
92696|NCT02072785|"     The purpose of this study is to determine whether vincristine sulfate liposome could reduce     less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine     sulfate in adults with Naïve Acute Lymphoblastic Leukemia.   "
92697|NCT02072772|"     The purpose of this study is to determine whether Positively Smoke Free group therapy is more     effective at promoting cessation than standard care.   "
92698|NCT02072759|"     Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased     metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state     to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is an     early hallmark in the development of diabetes. Recent evidence suggests that a low carnitine     availability may limit acetylcarnitine formation, thereby reducing metabolic flexibility. We     propose to test the hypothesis that metabolic inflexibility in pre-diabetic subjects and     diabetic patients is due to a reduced capacity to form acetylcarnitines.   "
92699|NCT02072746|"     The purpose of this study is to determine if zinc therapy: (1) strengthens your intestine's     defensive barrier preventing damaging substances from reaching your liver, (2) decreases     liver injury (inflammation, oxidative stress, cell death) and scarring, and (3) improves your     liver-related health. Based on our preliminary animal data and other published reports, we     expect zinc therapy to achieve all of these goals. Zinc is affordable, available over the     counter or by prescription, and has an excellent safety profile. Positive results from this     study will show that zinc is a significant therapy for millions of Americans with alcoholic     liver disease.   "
92700|NCT02072733|"     A Feasibility study Geriatric assessment applied to patients with cancer of the head and     neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of     planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to     patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is     planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to     all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The     Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or     fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic     treatment intensity, and 4) to investigate the ability of CGA to predict complications to     cancer treatment within a three months period.   "
92713|NCT02072564|"     The purpose of this study is study the possible relationship between various lifestyle habits     of men and women (age, body mass index, diet, exercise, alcohol, tobacco, coffee, etc..) and     live birth rate after in vitro fertilization-intracytoplasmatic injection (IVF-ICSI).   "
92701|NCT02072720|"     The main question of this study is if and when VEGF (vascular endothelial growth factor)     expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits     subsequent vessel growth in the tumor.        -  Therefore the first aim of this study is to identify the time point of induction of VEGF          in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks          of chemoradiation).        -  If we identify increased expression of VEGF at a certain time point, our second aim is          to determine if we can inhibit the subsequent tumor vessel growth by administration of          bevacizumab.   "
92702|NCT02072707|"     The investigators hypothesized that combined endocardial and epicardial VT ablation using     contact sensor irrigated catheter is safe and achieves a lower recurrence rate than     endocardial only ablation in ischemic and non-ischemic patients, for this the investigators     will randomize 20 patients in two groups, one with endocardial only ablation and other with     combined endocardial and epicardial ablation.   "
92703|NCT02072694|"     This study evaluates the hypothesis that a meal constituted of only glucose produces     differences in the brain blood flow in people with obesity that are not observed in people     without obesity. These changes, at least in part, could explain the mechanisms involved in     maintenance or development of obesity.   "
92704|NCT02072681|"     The objective of this study is to determine the 90-day outcomes of mild and rapidly improving     ischemic stroke.   "
92861|NCT02070627|"     The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to     assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in     patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of     NIRF-C in identifying the cystic duct junction during cholecystectomy.   "
92705|NCT02072668|"     The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce     inflammation, coagulation and endothelial cell activation, and improve microvascular blood     flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test     this hypothesis, this study will evaluate the effects of rivaroxaban on:        -  plasma markers of inflammation;        -  plasma markers of endothelial activation;        -  plasma markers of thrombin generation; and        -  microvascular blood flow assessed using laser Doppler velocimetry (LDV) of          post-occlusive reactive hyperemia (PORH).      In a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks     each, separated by a 2-week washout phase.   "
92706|NCT02072655|"     In the early 2000s , professional and patient organizations are mobilizing to highlight the     psychosocial impact of cancer disease , not only during but also after the acute phase.      In 2003, the government launched the Cancer Plan I reinforced in December 2011 by the Cancer     Plan II whose objectives include :  Develop a personalized care taking into account the pain     and psychological and social support  and  increase opportunities for patients to benefit     from supportive care and promote the professional integration .      This study aims to show that beyond the immediate benefits of the social aesthetic cares in     hospital (direct soothing, improving the quality of the skin injured by chemotherapy ,     feeling of escape ... ), these treatments can also affect quality of life for patients during     and after hospitalization. They also may have an impact on the maintenance of social and / or     professional satisfactory throughout the planned chemotherapy aplastic period .   "
92707|NCT02072642|"     Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor     symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and     impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these     patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT)     represents one such innovative therapeutic approach. Although light has an obvious to visual     pathways within the brain, today it is known to additionally exert non-visual effects     throughout the body. Recently our team has shown that non-visual, non-circadian light plays a     major role in the regulation of sleep, as well as cognitive brain function in general. The     retina, the primary conduit for the transmission of light information is weakened or thinned     in Parkinson's patients. The dopamine system is known to enhance the processing of light     information and intraocular injection of L-dopa in animal models of Parkinson's disease, can     reverse associated motor symptoms. This allows for the possibility that LT would strengthen     the dopaminergic tone in the central nervous system. However, to this date its effectiveness     for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly     controlled. Thus, through the convergence of basic and clinical data, a study examining the     effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the     effects on sleep, circadian system, mood, and cognitive functioning, is of extreme     importance. With this information our hope is to determine if these polymorphisms allow for a     predictive model of response to LT treatment.   "
92708|NCT02072629|"     This study will assess how the current VHV (VHV=CHW, community health worker) scope can be     expanded to include iCCM and if such group interventions can provide improved access to     treatment for children.      In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children     with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving     anti-malarials?   "
92709|NCT02072616|"     Histological proof is a crucial and necessary step for appropriate care in oncology. In the     case of pancreatic cancer, histological proof from pathological analysis of the surgical     specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to     surgical resection. In most cases, invasive endoscopic explorations are necessary for     histological diagnosis before deciding of the most appropriate treatment (palliative     chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration     (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological     diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia     with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and     92% in situations where three different procedures are required. EUS-FNA has to be performed     by a physician properly trained for this type of interventional endoscopy. Some severe     complications may occur but are relatively rare in expert centers (bleeding, perforation,     complications of general anesthesia ...).      Diagnostic alternative approach is biological with research in the peripheral blood of     markers of tumor disease. It is possible to detect indirect markers which are molecules     produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor     biological material (circulating tumor cells (CTCs) or circulating tumor DNA).      The value of detection of CTCs is not determined for the diagnostic and therapeutic     management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of     circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable     forms.   "
92715|NCT02072538|"     New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute     myocardial infarction (AMI). Furthermore, elevated values were associated with an increased     risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in     patients with elevated admission values and kinetic changes. Other criteria for an early     invasive strategy include a GRACE risk score >140 points or other cardiovascular risk     factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies     confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim     of this study is to 1) confirm the safety of early discharge without invasive strategy in     patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients     are being randomized into 2 groups with pre-discharge and early post-discharge     stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.   "
92716|NCT02072525|"     The purpose of this study is to collect serum samples for use as quality control samples in     GSK assays. The serum samples need to include samples with low, medium and high antibody     titers/concentrations, which cover the assay range.   "
92717|NCT02072512|"     The purpose of this study is to assess the efficacy of goserelin plus fulvestrant 500mg     comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and     perimenopausal HR+ advanced breast cancer.   "
92719|NCT02072486|"     This clinical trial studies sorafenib tosylate in treating patients with liver cancer that     cannot be removed by surgery. Sorafenib tosylate may block some of the enzymes needed for     tumor cell growth. Blocking these enzymes may also help the immune system work better.     Granzyme B is a biomarker that can be used to measure how well the immune system is working.     A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a     sign of a normal or abnormal process, or of a condition or disease. Studying granzyme B     levels in patients receiving sorafenib tosylate may help doctors learn more about the effects     of sorafenib tosylate on the immune system and may help to predict how well sorafenib     tosylate will work in treating patients with liver cancer.   "
92720|NCT02072473|"     This proposal aims to evaluate safety and efficacy aspects of a new protocol for AVNRT     ablation, using a stepwise anatomical approach.      The investigators hypothesize that the use of a standardized electro-anatomical guided     strategy, using a sequential approach as follows:        1. Right-side postero-septal tricuspid annulus        2. Coronary sinus        3. Left-side postero-septal mitral annulus      For slow pathway AVNRT ablation is safe and efficient, increasing the chance of a successful     ablation in difficult cases, while reducing the need of re-do procedures and the risk for     high-degree atrio-ventricular block.      The investigators aim to define and implement a new standardized protocol for AVNRT ablation     while at the same time assessing the efficacy and safety of coronary sinus and left-side     approaches for slow-pathway ablation.   "
92721|NCT02072460|"     The present project aims at describing how vestibular signals contribute to the multisensory     mechanisms of bodily self-consciousness.      There is a large body of data regarding the sensory and neural mechanisms of     self-consciousness, but most studies have so far demonstrated the contribution of visual,     tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have     neglected the contribution of the vestibular system, a major sensory system for spatial and     bodily representations. The vestibular system is sensitive to head motions in space and head     inclinations with respect to gravity and it should therefore contribute significantly to     several bodily experiences. This contribution should be put under neuroscientific scrutiny.     We believe that the current neuroscientific models of bodily self-consciousness will be     incomplete until they incorporate the contribution of vestibular signals.      The present project specifically aims at testing the hypothesis according to which vestibular     signals significantly influence bodily self-consciousness, in particular first-person and     third-person perspective taking and the internal body models (i.e. the body schema and body     image). The present project also aims at describing how cortical vestibular processing is     modified during experimental changes of perspective taking and viewpoint. In addition, the     present project will describe whether vestibular disorders change performances in     third-person perspective taking tasks and modify internal body models. This should help     understanding bodily symptoms in vestibular-defective patients. To this end, we will combine     approaches from psychophysics and electrophysiology (electromyography,     electroencephalography) in healthy volunteers and behavioral approached in patients with     vestibular disorders.      These studies should further the understanding of how the brain processes vestibular signals,     which is to date poorly understood. In addition, the outcome of the present project should     help understanding the multiple and complex symptoms reported by patients with vestibular     diseases, and should therefore improve their treatment.   "
92722|NCT02072447|"     This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral     therapeutic- and [14C]-labeled intravenous microdoses.   "
92723|NCT02072434|"     The purpose of this study is to compare edoxaban (investigational drug) with warfarin and     enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot     complications in subjects with atrial fibrillation whose doctors plan to treat them with an     electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North     America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive     either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required.     Participants will have an equal chance of receiving either treatment. Participants will be in     the study for a maximum of 82 days. Study procedures will include physical examinations,     vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood     clotting tests, blood samples, urine samples and completion of Quality of Life     questionnaires.      The study is expected to show that edoxaban will provide comparable incidence rates for     efficacy to warfarin plus enoxaparin, the current standard treatment, and will be at least as     safe as warfarin for the incidence rate for bleeding   "
92724|NCT02072421|"     The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess     the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in     patients with myocardial ischemia (other than ST-segment elevation myocardial infarction     [STEMI]).   "
92725|NCT02072408|"     The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment     of polypoidal choroidal vasculopathy without active polyp.   "
92726|NCT02072395|"     The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical     procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.   "
92727|NCT02072382|"     The proposed study is to evaluate the possible effect of metformin on arterial pressure by     24h-ambulatory blood pressure monitory (24h-ABPM).   "
92728|NCT02072369|"     The purpose of this study is to investigate the benefits of incorporating an actuated,     EMG-controlled glove into occupational therapy of the hand.   "
92729|NCT02072356|"     This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in     treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses     radioactive material placed directly into or near a tumor to kill tumor cells. Using     radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.   "
92730|NCT02072343|"     Capnometer has been used to assess the success of intubation and the quality of     cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions such     as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water.     Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of     capnometers under the conditions of water.   "
92731|NCT02072330|"     The objective of this study is to compare the efficacy and safety of combined administration     of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide     (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.   "
92732|NCT02072317|"     The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy     in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced     gastric cancer   "
92733|NCT02072304|"     The purpose of this study is to develope web-based cognitive behavioral therapy for Korean     adoldescents who have a mild depression. And we will investigate whether web-based cognitive     behavioral therapy is more effective than supportive psychotherapy for treating depressed     adolescents. Our hypothesis is web- based cognitive behavioral is more effective than     supportive psychotherapy   "
92734|NCT02072291|"     The main factors associated with pregnancy rate in In Vitro Fertilization (IVF) treatment are     embryo quality and the uterine ability to accept the embryo for implantation. This ability is     influenced by uterine contractions (UC), which change in pattern and direction during the     menstrual cycle. An abnormal uterine contraction pattern can displace the embryo from the     proper position in the uterine cavity towards the cervix or the fallopian tubes and as a     result may decrease pregnancy rates and increase the risk of ectopic pregnancy. Indeed,     previous studies demonstrated a negative correlation between uterine contraction rate and     implantation/pregnancy rates. Suppression of uterine contractions during embryo transfer can     be achieved by a large array of drugs, such as cyclo-oxygenase inhibitors, β2-adrenoreceptor     agonists, calcium-channel blockers, phosphodiesterase inhibitors and oxytocin antagonists.     The objective of this study is to evaluate the efficacy of Nifedipine administration in     reducing uterine contractility during IVF-frozen embryo transfer (FET) treatment.   "
92735|NCT02072278|"     To explore a neurophysiological marker (electroencephalography) of cognitive effect of     vortioxetine   "
92736|NCT02072265|"     Permanently implantable venous ports (Port-A) is very important to patients receiving     chemotherapy. It not only provides a reliable route to administrate intravenous drugs, and it     also requires minimal care when it is not in use. However, catheter related blood stream     infection(CRBSI) is one of the serious complications of Port-A. The diagnosis of CRBSI relies     on limited tools, including blood culture or symptoms and signs of active infection. In the     stage of CRBSI, Port-A removal is necessary and pose the risk for the patients to re-implant     the Port-A. Thus, it is crucial to early detect the infection and give appropriate treatment.     Among the pathogens, some pathogens are related to skin contaminants. Before systemic     spreading, these pathogens may colonize or cause minor infection subcutaneously. This     investigation is to utilize a non-invasive dual spectrum infrared imaging system to evaluate     the Port-A wound and to detect the infection.      Aim: 1. To build the database of infra-red thermal images of Port-A wound healing. 2. To     investigate the thermal images of skin contamination related CRBSI and to compare with the     thermal images of the CRBSI of unknown foci   "
92737|NCT02072252|"     The purpose of this study is to determine whether a mobile phone application (app) for     symptoms of depression and anxiety is practical and acceptable to young men who are attracted     to men, and whether it reduces their anxiety and depressive symptoms. The investigators will     also evaluate whether reductions in symptoms are maintained over a 10 week follow-up period     after young men complete the mobile phone intervention.   "
92738|NCT02072239|"     The purpose of this study is to determine whether or not the Angioshield device can be safely     applied to support saphenous vein grafts used in standard coronary bypass surgery.   "
92739|NCT02072226|"     PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy     and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes     that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to     receive within 3 hours of last known well time either 1) one dose of IV alteplase and one     dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral     aspirin 325 milligrams (mg).   "
92740|NCT02072213|"     Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male     Volunteers   "
92741|NCT02072200|"     This study is multicenter, Ph IV, single arm, interventional study to assess relative     reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication     will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after     2, 6 and 12 weeks after treatment (visit 2,3,4).   "
92742|NCT02072187|"     Low levels of vitamin D have been associated with depression. This study will test if a     vitamin D supplement is helpful in patients with depression who have not found relief with     the use of anti-depressant medication. Participants will continue to take their medication     plus vitamin D or placebo for 8 weeks. The investigators will monitor their depression     symptoms and the investigators think that the people taking vitamin D may have an improvement     in their symptoms.   "
92743|NCT02072174|"     The purpose of this study is:      • To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment     of influenza and acute respiratory viral infections in children   "
92744|NCT02072161|"     The purpose of this research study is to see how ETC-1002 is tolerated in the body and how     ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin     therapy.   "
93302|NCT02064816|"     This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4     study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a     lower severity of flu-like symptoms (FLS) as compared to the evening administration, in     subjects with relapsing multiple sclerosis (RMS).   "
92745|NCT02072148|"     In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell     Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high     risk for long-term toxicity and mortality from therapy. While the long-term consequences of     chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose     radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ     function and result in a significant rate of late mortality and morbidity in patients.     Studies are now being designed to reduce the impact of RT and CRT for patients.      Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor     prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good     prognosis features will then be followed without postoperative radiotherapy. Patients with     subsequent recurrence will be treated with either surgery and postoperative radiotherapy or     postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI)     will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is     expected that over 50% of patients treated with surgery will have had a curative treatment     and will avoid radiation therapy entirely and long-term survival will not be changed by     withholding radiation therapy to good prognosis patients after surgery. There are exploratory     biomarkers of risk of recurrence that will be collected and studied.      There are currently few trials examining the role of de-escalation using surgery alone in     intermediate and early T-stage HPV related disease. New surgical techniques have broadened     the range of patients capable of achieving a complete resection and the functional outcomes     in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and     radiotherapy raise the possibility that delayed or salvage treatment in early stage patients     would be highly effective, would result in similar survival outcomes and radiotherapy could     be applied to a much smaller population then current standards call for. Looked at from a     different perspective, the need for post-operative radiotherapy in this younger, HPV+ and     more functional population has not been validated in clinical trials to date.   "
92974|NCT02069132|"     The purpose of this study is to validate the International Warfarin Pharmacogenetics     Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older)     with heart valves and/or nonvalvular atrial fibrillation (AF) and at least one comorbid     condition, and to assess the algorithm's prognostic relevance.   "
92746|NCT02072135|"     This study involves a drug called Exparel that has been approved by the US Food and Drug     Administration (FDA), for application directly to wound sites. EXPAREL® is a long acting pain     reliever. It is being given in this study to see if it provides safe and effective pain     relief after ankle surgery. Because it is a long acting drug, it may lessen pain relief for     as much as 72 hours after surgery.      EXPAREL® has not been approved by the FDA for administration by popliteal block, which is the     method the study doctors will use to give the patients the drug. Giving the drug by popliteal     block involves inserting a small tube in to the back of the knee to deliver the drug. The     study doctors wish to determine if patients undergoing ankle surgery and receiving this drug     have less pain and less need for narcotic medication.   "
92747|NCT02072122|"     The purpose of this study is to determine the relation between estrogen and progesterone     levels, and between dryness of the eyes, in women during their fertile years.   "
92748|NCT02072109|"     Early initiation of enteral feeding, achievement of full enteral feeding and cessation of     parenteral nutrition are extremely important in the very premature infant. This way it is     possible to achieve good post-natal growth and developement while minimizing the metabolic     and infectious complications of parenteral feeding.      There isn't much information in literature regarding the impact of enteral feeding on     intestinal blood flow and intestinal regional oxygenation in the preterm infant. There is     also no consensus regarding the best regimen of delivering the enteral nutrition - bolus     feeding or continuous feeding.      The aim of our study is to compare the intestinal regional oxygenation before and after two     feeding regimens - bolus feeding and continuous feeding - in clinically stable preterm     infants born before 32 weeks gestation. The evaluations will be performed using NIRS     technology (Near Infrared Spectroscopy).      The study may help to assess which feeding regimen is gentler to the immature intestines     (i.e. alters less the splanchnic blood flow and oxygenation) and therefore the preferred way     to feed preterm infants.   "
92749|NCT02072096|"     The main purpose of this study is to compare the benefits and risks associated with the use     of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM.     One strategy is based on the use of oral and injectable medications that only reduce blood     sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents.     The trial will last up to 72 weeks for each participant.   "
92750|NCT02072083|"     The aim of this study is using intranasal dexmedetomidine versus intranasal     midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of     pediatric patients undergoing strabismus surgery.   "
92751|NCT02072070|"     The purpose of this study is to determine whether TissueGene-C, an allogeneic human     chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients     with degenerative arthritis.   "
92752|NCT02072057|"     The aim of this study is to investigate the effects and safety of Ruxolitinib, a Janus kinase     1 (JAK1) and Janus kinase 2 (JAK2) inhibitor for the treatment of tumor-associated cachexia     in chronic wasting diseases.   "
92753|NCT02072044|"     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance     to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in     patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.   "
92754|NCT02072031|"     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance     to new angiogenesis. The trial is to compare the efficacy and safety profile between     Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).   "
92755|NCT02072018|"     Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the     safety and efficacy of a new compound to treat this disease.   "
92756|NCT02072005|"     The primary aim of this study is to conduct a 9-patient feasibility and acceptability study     of mSMART (with future studies focusing on improved medication adherence). The sample will     include daily smokers who are already taking a prescribed medication. There will be no change     in any medication regimen in this study, and the sample will include smokers either with or     without a psychiatric disorder. Subjects will be asked to use a smartphone application, or     app (i.e. mSMART) that will provide information about their medication and when to take it.     Along with smart phone, the participants will be asked to utilize an electronic pillbox (i.e.     GlowCap) to further assist with medication compliance.   "
92841|NCT02070887|"     The overall aim of this observational study is to investigate the impact of COMT inhibition     on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD     patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering     to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or     computer-based.   "
92757|NCT02071979|"     This study will examine differences in the process of wound-healing in patients treated with     platelet rich plasma (a concentration of proteins derived from a patients own blood) applied     to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to     patients treated with usual medical treatment . This study seeks to enroll patients who are     18 or older with a non-healing skin wound that is at least 30 days old. Only patients with     Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.   "
92858|NCT02070666|"     The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury     Prediction Score), under mechanical ventilation could benefit from a protective ventilatory     strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This     would lead to a decrease in incidence, mortality and health care costs associated to this     syndrome.      This study will help to confirm the current evidence about low tidal volumes, evaluating     adverse events of this strategy.   "
92975|NCT02069119|"     To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous     intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to     patients with paroxysmal or persistent atrial fibrillation   "
92758|NCT02071966|"     The aim of the study is to learn more about the pathophysiology of acute coronary syndrome     (ACS) and to evaluate the mechanisms responsible of the action and benefits of ticagrelor.      Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor. Few information is     available about the action of ticagrelor on the molecules involved in thrombogenesis and     platelets activation in ACS.      The aim of this study is to evaluate the mechanisms of ticagrelor action in vivo.      It was observed that patients with myocardial infarction have higher blood levels of     microparticles than patients with unstable angina or stable angina.      The investigators assumed that ticagrelor benefits are represented by a reduction of     microparticle levels, a marker of endothelial dysfunction in patients with cardiovascular     disease, and by a modification in microRNAs pattern, fragments of mRNA that have a regulatory     action in various cellular processes (such as proliferation, differentiation, growth and     cellular death) and represent new biomarkers in ACS.   "
92759|NCT02071953|"     The intent of this study is to evaluate the clinical performance of an experimental dental     bonding agent for use with dental restorative composites with and without pretreatment of the     tooth dentin and enamel using phosphoric acid etching.   "
92760|NCT02071940|"     KIT (receptor tyrosine kinase) mutations occur in 15% of acral and mucosal melanomas. PIANO     is a single arm, phase II, open-label, multicentre study to evaluate the efficacy and safety     (plus molecular basis of such effects) of the KIT inhibitor PLX3397 (developed by Plexxikon)     in advanced KIT mutated acral and mucosal melanoma.      In this trial a total of 24 patients (9 in the first stage and 15 in the second stage) will     receive treatment over a 24 month recruitment period.      Following consent and successful screening, patients will receive PLX3397 capsules 1000mg/day     as monotherapy, and will remain on therapy as long as they are deriving clinical benefit.     Patients will be seen every 4 weeks during treatment to monitor response and toxicity.     Routine blood tests will be carried out at all visits and pharmacokinetics/pharmacodynamics     sampling (1 x 8 milliliter(ml) whole blood sample) will be done pre-dose on Day 1 and Day 15,     frozen and stored locally and sent to Plexxikon's vendor for central analysis at the end of     the study. Imaging will be carried out every 12 weeks to monitor response. The first 9     patients will also receive two [18F]-fluorodeoxyglucose (FDG) PET scans (baseline and at Day     15).      From specific named participating sites, 12 patients will provide additional (optional)     consent to take part in translational research. 5 of these patients will have a fresh tumour     biopsy taken at baseline, at day 15 and upon disease progression. The same 5 patients plus an     additional 7 patients (to give a total of 12 patients) will also donate blood samples at     baseline, 2 weeks, 12 weeks and on disease progression for the evaluation of circulating     tumour cells and circulating free tumour DNA.      All patients will be followed up every 6 months until death or for 12 months after the last     patient has discontinued study treatment.   "
92761|NCT02071927|"     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine     utilization, glutaminase, will be tested in this Phase 1 study in patients with leukemia.      This study is an open-label Phase 1 evaluation of CB-839 in subjects with leukemia. Part 1 is     a dose escalation study to identify the recommended Phase 2 dose as a single agent and in     combination with azacitidine. Patients enrolled into Part 2 will be treated with the     recommended Phase 2 dose. As an extension of Part 2, patients with relapsed/ refractory or     newly diagnosed AML will be treated with CB-839 in combination with azacitidine.      All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),     pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may     predict responsiveness in later studies), and tumor response.   "
92762|NCT02071914|"     This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from     nasopharyngeal mucosa, compared to placebo.   "
92763|NCT02071901|"     This phase II trial studies how well eltrombopag olamine works in improving the recovery of     platelet counts in older patients with acute myeloid leukemia undergoing induction (the first     treatment given for a disease) chemotherapy. Platelet counts recover more slowly in older     patients, leading to risk of complications and the delay of post-remission therapy.     Eltrombopag olamine may cause the body to make platelets after chemotherapy.   "
92764|NCT02071888|"     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine     utilization, glutaminase, will be tested in this Phase 1 study in patients with advanced     hematologic malignancies.      This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological     tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will     be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase     2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's     Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM)      In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll     patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple     Myeloma (MM), or Waldenström's macroglobulinemia (WM). All patients will be assessed for     safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of     glutaminase), biomarkers (biochemical markers that may predict responsiveness in later     studies), and tumor response.      As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be     enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with     relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled     to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone     to further evaluate this triple combination.   "
92765|NCT02071875|"     To determine the efficacy of using the Jan Medical NNW system as a diagnostic aid in     detection of moderate and severe vasospasm for detection of vasospasm in patients with     subarachnoid hemorrhage.   "
92823|NCT02071121|"     The primary objective of this study is to evaluate the safety and tolerability of single     doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study     population are to determine the single-dose pharmacokinetic (PK) profile and the absolute     bioavailability (Fabs) of BIIB061 and to determine the effects of food intake (high-fat,     high-calorie meal) on BIIB061 PK and safety.   "
92859|NCT02070653|"     Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause     of death in Europe and North America. A key limitation of contemporary treatment strategies     of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an     effective treatment for large AAA, it is associated with significant mortality and morbidity     as well as substantial cost. The rationale for this randomized controlled study is to     investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic     aneurysms.   "
92766|NCT02071862|"     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine     utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors.      This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid     tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling     patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839     capsules orally twice or three times daily.      In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative     Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)     Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase     (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H)     tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation     tumors.      As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with     standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo.     Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and     CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with     everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M     EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring     KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with     histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated     with cabozantinib in combination with CB-839.      All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),     pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may     predict responsiveness in later studies), and tumor response.   "
92767|NCT02071849|"     The HAART 200 Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction Trial is a     prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of     the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve     annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic     insufficiency (AI).   "
92768|NCT02071836|"     The overall objective of this project is to develop, evaluate, and disseminate a web     application for first-time DWI offenders that will provide them with an age-appropriate brief     motivational intervention (BMI) to motivate them to reduce their drinking and a cognitive     behavioral intervention (CBI) for to help them achieve and maintain abstinence. The goal is     to reduce heavy drinking and consequently the risk for future drunk driving.      The specific objectives of this Phase II are:        -  Completing the development of the Right Turns prototype based on feedback from the Phase          I pilot study participants. This includes: providing more structure and guidance as          participants work in the Tool Box section of the program; simplifying the content of the          Tool Box; further R&D in the text messaging feature for 2nd and 3rd tier cellular          providers; implement a customized pdf report function for progress reports from the          program to users' probation officers (under control of the user); developing a follow-up          component and outcome reports; and revising the videos in the Tool Box to reflect          greater diversity and a younger population of drinkers.        -  Conducting a randomized clinical trial of the program with first time DWI/DUI offenders          who are recruited locally, collecting follow-up data, analyzing the data, and reporting          the results.   "
92769|NCT02071823|"     The objectives of this study were to characterize the effects of food on the pharmacokinetics     (PK) and tolerability of BIA 9-1067 in healthy male subjects.   "
92770|NCT02071810|"     The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising     dose regimens of BIA 9-1067.   "
92771|NCT02071797|"     The objective of the COOLCATH study is to compare the effect of the RhinoChill transnasal     cooling system to current standard Blanketrol III cooling blanket in its ability to achieve     therapeutic hypothermia (TH) induction for patients undergoing TH after cardiac arrest.      The COOLCATH study will be a prospective, open-label randomized controlled trial comparing     induction of TH efficacy and outcomes of patients following cardiac arrest. Any patient with     return of spontaneous circulation (ROSC) following a cardiac arrest within the Essex     Cardiothoracic Centre (CTC), or who is brought to the Essex CTC and is a candidate for TH     will be considered for this study.   "
92772|NCT02071784|"     The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical     models, the potential alterations of neurovascular coupling in CADASIL.   "
92773|NCT02071771|"     The purpose of this study is to evaluate functional vision associated with rotational     stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE®     MOIST® for Astigmatism (1DAM A).   "
92774|NCT02071758|"     The purpose of this study is to compare the safety, tolerability, and immunogenicity in     healthy adult subjects of an investigational vaccine being developed for the prevention of     visceral leishmaniasis.   "
92775|NCT02071745|"     Total knee replacement is one of the most commonly performed orthopedic procedures. As of     2010, about 600,000 total knee replacements were being performed annually in the United     States and these numbers are rising. The normal knee joint functions as a complex hinge     allowing primarily ﬂexion and extension, rotation and gliding. The knee joint is made up of     three compartments, the lateral, medial and anterior (patellofemoral). Damage to the     cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or     post-traumatic), inﬂammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis,     tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of     the overwhelming majority of total joint arthroplasties.      A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the     mechanical axis in axial and rotational planes), as well as significant pain relief which     improves function and quality of life. Incorrect alignment can lead to abnormal wear,     premature mechanical loosening of the components and patellofemoral problems.      The common techniques for Total knee replacement are:        1. Conventional method TKR        2. CT/MRI-based preoperative navigated TKR        3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method using          the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active          PC based guiding system that helps the surgeon decide on the accurate alignment and          orientation of the implant and cutting surfaces of the bone and thus avoid incorrect          alignment.      We aim to compare between pre-operative and post-operative lower limb alignment (mechanical     axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the     existence of a correlation between the CT scans and the Orthopilot navigation system output     and assess the clinical outcome of the patient postoperatively.      Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT     images results, moreover, allows the surgeon to achieve a good mechanical axis and high     clinical outcome,   "
92776|NCT02071732|"     The purpose of this study is to determine whether repetitive transcranial magnetic     stimulation (rTMS) is effective in the treatment of tinnitus.   "
92824|NCT02071108|"     To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects     to demonstrate that the Shockwave device can safely and effectively deliver localized     shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral     arteries.   "
93116|NCT02067286|"     The objective of this study is to evaluate the clinical sensitivity and specificity of the     Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat     Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a     nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.   "
92777|NCT02071719|"     The rapid development of agents blocking kinases has established the use of molecularly     targeted therapy as the preferred treatment approach for patients with metastatic renal cell     cancer (RCC). Five kinase inhibitors (sunitinib, everolimus, temsirolimus, sorafenib and     pazopanib) are now approved for clinical use. Response rates differ among these agents,     importantly depending on line of treatment. In first-line treatment sunitinib results in 47%     objective response rates, where in second-line after cytokines 34% responds. Thus far, it is     unclear which patient with advanced renal cell cancer will respond to targeted therapy. In     order to select patients for targeted therapies, several profiling approaches have been     explored but to date no adequate and reliable test is available. It is assumed that responses     to targeted agents depend on specific receptor and protein signalling activities in tumor     tissues. Therefore, we propose that protein phosphorylation profiling with phosphoproteomics     may be a potential clinical diagnostic tool to predict for tumor response to targeted     therapy.   "
92778|NCT02071706|"     The investigational PET/MRI scanner, including attenuation correction method, is capable of     producing diagnostic quality images and appropriate device functionality per user feedback.   "
92779|NCT02071693|"     To retrospectively investigate the relationship between the Cholinergic Pathways     Hyperintensities Scale (CHIPS) score and the change of cognitive status of Parkinson's     disease (PD) patients after bilateral subthalamic nucleus deep brain stimulation (STN DBS).   "
92780|NCT02071680|"     Patients with symptomatic atrial fibrillation (AF), a rapid beating of the upper heart     chambers, can undergo catheter ablation to control or eliminate their rhythm disorder. The     radiopharmceutical 123I-mIBG (Adreview™ GE Healthcare) has been introduced to visually     identify cardiac innervation. This study will use non-invasive evaluation using MIBG imaging     to study if we can predict baseline autonomic characteristics in patients with AF, as well as     clinical outcome based on post ablation imaging   "
92781|NCT02071667|"     The purpose of this study is to see if a protein in blood, called periostin, can determine if     patients have chronic sinusitis. This protein is in everyone's body, but the level of the     protein may indicate certain conditions such as chronic sinusitis. The investigators are     interested in testing levels of periostin to see if they are higher or lower than patients     without chronic sinusitis, just as periostin is higher in patients with asthma. All patients     enrolled in this study will have chronic sinusitis without asthma.   "
92782|NCT02071654|"     A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the     treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart     defect.   "
92783|NCT02071641|"     Targeted therapies are associated with (acquired) resistance after a median of 5-11 months of     treatment, resulting in disease progression, while almost no tumors are intrinsically     resistant in the first line setting. The investigators recently published that tumor cell     resistance to sunitinib may be directly related to lysosomal sequestration of sunitinib. This     resistance mechanism was shown to be transient, since a drug-free culture period could     normalize the lysosomal storage capacity for sunitinib and resulted in recovery of drug     sensitivity.      In two reports it has been suggested that patients with metastatic Renal Cell Carcinoma who     responded to sunitinib in the first-line setting may benefit from rechallenge with sunitinib     after failure of second-line treatment. However, these data are retrospective. A prospective     trial to investigate a rechallenge with sunitinib is needed to determine whether this     strategy is of benefit for patients with mRCC with prior clinical benefit to sunitinib but     who stopped treatment because of overt clinical resistance.   "
92784|NCT02071628|"     This study is designed for validation of in-vitro platelet aggregation assay using human     blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for     platelet aggregation assay, was collected from ten subjects, respectively.      Preparation of Platelet Rich Plasma (PRP):        1. Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate          vacutainer vials.        2. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at          room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP          from multiple vacutainer tubes (if required) into a 15 mL conical tube.        3. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15          minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL          conical tube.        4. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar          product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets          in PRP using PPP.      Aggregation Measurement:      Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP     is used as a reference to establish 100% optical transmission.   "
92785|NCT02071615|"     In this study the investigators compare three stimulants to each other. The effects of these     agents on cognitive performance (eg, attention and memory) and on the brain are being     measured. The hypothesis is that stimulants will have a positive effect on cognitive     performance.      Each study participant will receive once a placebo and once methylphenidate or modafinil or     caffeine. Methylphenidate (also known as Ritalin ®) is a drug that is used in the treatment     of attention deficit / hyperactivity disorder (ADHD) in children, adolescents and adults.     Modafinil ( Vigil ®) is a drug used in the treatment of narcolepsy (sleeping sickness). In     the study. These substances are given in the study only once and in the dosages in which is     also used for the treatment of the above diseases. In the case of caffeine , the dosage     corresponds to two cups of coffee.   "
92786|NCT02071602|"     The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the     incidence of symptomatic hypotension being one of the key safety variables.   "
92787|NCT02071589|"     Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new     oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female     volunteers.   "
92788|NCT02071576|"     This clinical study has been planned to evaluate the safety and effectiveness of a common     treatment algorithms (Proscan) using 500 Hz laser repetition rate.   "
92839|NCT02070913|"     A single-center, prospective case series clinical study consecutively enrolling up to 10     patients with expected duration of 12 months or less. The study objectives are to evaluate     retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM     System.   "
92789|NCT02071563|"     This research will serve as a follow-up on the review of Title II commodities performed by     the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso     will test the relative effectiveness and cost effectiveness of four supplementary foods in     the prevention of MAM and stunting in normal programmatic settings.      The aims of this study are to:        1. To compare the effectiveness of four alternative supplementary food commodities in          preventing stunting and wasting, and promoting linear growth in children 6 - 23 months          in the context of a preventive supplementary feeding program in Burkina Faso.        2. To estimate the relative cost of implementing the supplementary feeding program using          each commodity        3. To estimate the relative cost/effectiveness of implementing the program using each          commodity.   "
92790|NCT02071550|"     In this study the investigators investigated changes in hemodynamic parameters and cerebral     oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the     respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at     the 30°head-up left side position, is compared with using two individual devices     (INVOS-FORESIGHT).      Methods: Afterwards the ethics committee approval of the hospital and receiving the written     patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were     randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the     right side forehead region. Totally 11 evaluation periods were formed, respectively:     Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd     period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of     insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th     period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10     cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data,     hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.   "
92791|NCT02071537|"     The purpose of this research study is to test the safety of chloroquine in combination with     carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid     tumors.      Also, the research study will be increasing the dose of chloroquine to find the highest dose     of chloroquine that can be given in combination with carboplatin and gemcitabine without     causing severe side effects.   "
92792|NCT02071524|"     The investigators hypothesize that large doses of fluids used during intraoperative could     affect lung parenchyma structure and, consequently, gas exchange and respiratory mechanics.     The purpose of this study is to evaluate fluids effects on oxygenation, respiratory     mechanics, by using two different solutions: crystalloid or colloid.   "
92793|NCT02071511|"     Study hypothesis:      With optimal medical therapy and repeated ablations, an additional renal denervation may have     protective effects in terms of vegetative intrinsic activity and lead to a significant     reduction in VT Burdens.      Study design:      Multicenter, randomized, prospective, single-blind clinical trial.   "
92794|NCT02071498|"     Background: Non-adherence and medication errors are common among patients with complex drug     regimens. Applications for smartphones and tablets are known to be effective for improving     adherence but they have not been tested in elderly patients with such complex chronic     conditions, their older age meaning they tend to have less experience with this type of     technology.      Objective: to design, implement and evaluate a medication self-management application for     elderly patients taking multiple medications called ALICE with the intention of improving     adherence and safe medication use.      Methods: A single-blind randomized controlled trial was conducted with a control and an     experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based     on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7     professionals. ALICE was designed for Android and iOS and to allow the personalisation of     prescriptions and medical advice, showing images of each of the medications (the packaging     and the medication itself) together with alerts and multiple reminders for each alert. The     randomly subjects in the control group received oral and written information on the safe use     of their medications and the experimental group used ALICE for three months. Pre- and post-     measures included: rate of missed doses and medication errors reported by patients, Morisky     Medication Adherence 4 items Scale scores, level of independence, self-perceived health     status and biochemical test results of the patients. In the experimental group, data were     also collected on their previous experience with information and communication technologies,     their rating of ALICE and their perception of the level of independence they had achieved.     The inter-group intervention effects were calculated by univariate linear models and ANOVA,     with the pre- to post-intervention differences as the dependent variables.   "
92795|NCT02071485|"     A brain-computer interface (BCI) is a system that provides a separate output pathway for     neurological signals whereby they can be interpreted to determine the user's intended     cognitive action. Utilizing EEG-based sensorimotor rhythms (SMRs) generated in the motor     cortex has allowed subjects to control virtual computer cursors in up to three dimensions by     simply imagining the movement of a specified body part. Nevertheless, the scalp EEG signals     are smeared by the volume conduction effect and measurement noise. The overall hypothesis of     this study is that EEG-based virtual object control may help reveal optimal motor imagination     tasks best used in a BCI.      The PI's hypotheses include: (1) The use of advanced signal processing techniques will better     reveal characteristics of EEG signals that represent the underlying motor cognitive function     of the subject; (2) BCI systems based on SMR generated using motor imaginations will allow     effective control of a virtual object in real time; (3) EEG imaging techniques will provide     insight into the areas of cortical activation during a motor imagery task that can be     utilized to increase the spatial resolution of non-invasive BCI's.   "
92796|NCT02071472|"     The objective is to evaluate the impact of an electronic pharmaceutical record used for     medication reconciliation by a pharmacist associated to the anesthesiologist consultation      Experimental intervention:      medication reconciliation by a pharmacist using an electronic pharmaceutical record before     the anesthesiologist consultation for planned surgery patients. The clinical pharmacist     communicates the recommendations regarding the drug therapy to the anesthesiologist orally     and using a specific formulary.      Control intervention:      Conventional anesthesiologist consultation for planned surgery patients.   "
92797|NCT02071459|"     Evaluate the effects of L-Threo DOPS on orthostatic hypotension symptoms and other non-motor     symptoms in patients with Multiple System Atrophy (MSA) after 12 weeks following     randomization to continued therapy with droxidopa or placebo.   "
92855|NCT02070705|"     This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic     resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a     procedure that takes detailed pictures of functional and structural properties inside the     body using magnetic field and radio frequency pulses. These pictures may help identify     underlying malignancy in patients at high risk or active malignancy in patients who have     undergone chemotherapy for pancreatic cancer.   "
92798|NCT02071446|"     Deep Brain Stimulation (DBS) is an FDA approved, and widely used method for treating the     motor symptoms of Parkinson's Disease (PD), Essential Tremor (ET) and Dystonia. Over 100,000     patients worldwide have now been implanted with DBS devices. The DBS target regions in the     brain are the Subthalamic nucleus (STN), the Internal Segment of Globus Pallidus (GPi), or     the Ventral Intermediate Nucleus of the Thalamus (VIM). In order to place the DBS electrode     in the target location, a combination of two 3D imaging techniques; 3D MRI and CT, are used.     Data are also collected from individual nerve cells to help find the best location for the     DBS electrode in each patient. This electrode recording takes place during the standard     surgical implantation of the DBS electrode, and is part of the standard clinical technique.     The investigators plan to collect additional data from populations of neurons during the DBS     surgery in an effort to further improve the placement of the DBS electrode. These Local     Field Potentials, LFPs, represent the activity of the collection of neurons surrounding the     tip of the electrode, and will be measured during surgery along the path used for the     placement of the DBS electrode. The goal of this project is to determine whether this     additional data from surrounding neurons will help with optimal placement of the DBS     electrode.   "
92799|NCT02071433|"     The purpose of this study is to determine whether blockade of the saphenous nerve can provide     the same degree of analgesia postoperatively for ACLS as a femoral nerve block without     resulting motor blockade enhancing shortening of hospital stay en functional outcome.   "
92800|NCT02071420|"     Our objective in this pilot study is to test the combined effect of a) replacing office     workers' sedentary workstations with active workstations (LifeBalance Station) and b)     optimizing computer workstation ergonomics on daily occupational sedentary time,     cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.   "
92801|NCT02071407|"     To explore the cerebral protective effect of midazolam in patients with traumatic brain     injury, we will collect blood samples from patients treated with or without midazolam when     the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of     midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h，     48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral     metabolism and inflammatory response will be obtained from the blood samples or the     cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical     outcome and cerebral metabolism and inflammatory response will be detected with statistical     method.   "
92802|NCT02071394|"     This study examines the effect of inhaled xenon gas in the treatment of newborn infants with     hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard     treatment for this condition. The hypothesis is that the xenon + cooling combination will     produce better neuroprotection than the standard treatment of cooling alone.   "
92803|NCT02071381|"     The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in     groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030   "
92804|NCT02071368|"     The purpose of this study is to assess the bioequivalence (similarity of the drug amount in     blood among the formulations) of the fixed dose combination (two components combined in one     tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150     mg/500mg) with respect to the individual components of canagliflozin (1 x 300 mg) and     metformin XR tablet (2 x 500 mg) in healthy fed participants.   "
92805|NCT02071355|"     The purpose of this study is to determine the pharmacokinetics (what the body does to a     medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7     days in healthy Chinese participants.   "
92806|NCT02071342|"     The aim of our study is to evaluate the clinical outcomes at 30 days and 1 year (cardiac     death, myocardial infarction, target lesion revascularization (TLR), target vessel     revascularization (TVR), thrombosis of the device in patients who are undergoing angioplasty     in myocardial infarction and in which bioabsorbable stent was implanted (BVS). Additionally,     we will evaluate the acute recoil after implantation of bioabsorbable stents. A 24 months     follow-up , by means of coronary angiography accompanied by QCA and assessment with     intracoronary ultrasound (IVUS) and VH (virtual histology) is scheduled.   "
92807|NCT02071329|"     The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity     of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers     following a dose of influenza A virus.   "
92808|NCT02071316|"     The purpose of this study is to conduct a randomized control trial, double-blind study to     compare Hexacapron with standard of care treatment to standard of care alone to evaluate the     efficacy of adding effect of Hexacapron to standard therapy by decreasing the episodes of     rebleeding and mortality in patient with upper gastrointestinal bleeding.   "
92809|NCT02071303|"     The purpose of this study is to compare the effectiveness of Tramadol and Celecoxib in     reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in     Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 1     hour before the procedure, the second group will receive Celecoxib 200mg 1 hour before the     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue     scale.   "
92810|NCT02071290|"     The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and     effective intervention to prevent the development of inflammation and coagulopathy in trauma     patients with hemorrhagic shock.   "
92840|NCT02070900|"     The study will be conducted at 32 health care facilities in three provinces in Zimbabwe and     will compare the impact of the provision Point of Care CD4 technology and early knowledge of     CD4 levels on retention at 12 months, with or without POC CD4 and a programmatic mentoring     package. Option B+ will be implemented at all sites and 16 intervention sites will receive     POC CD4 machines and visits from a team of clinical mentors.      The study also aims to assess rates of ART initiation and time to ART initiation of HIV     positive pregnant women in settings implementing option B+ with or without POC CD4 and     related counselling/support; rates of retention in care of HIV positive mothers at 6 months     post ART initiation in settings implementing option B+ with or without POC CD4 and related     counselling/support; rates of ART initiation and retention at 6 and 12 months post ART     initiation according to different levels of CD4 count; cost of retaining HIV positive     pregnant women until 6 and 12 months; acceptability and feasibility of POC CD4 as an adjunct     to good clinical care of HIV positive pregnant women.   "
92811|NCT02071277|"     Mechanical ventilation (MV) is a cornerstone of management of acute respiratory failure, but     MV per se can provoke ventilator-induced lung injury (VILI), especially in acute respiratory     distress syndrome (ARDS). Lung protective ventilation strategy has been proved to prevent     VILI by using low tidal volume of 6-8 ml/kg of ideal body weight and limiting plateau     pressure to less than 30 cmH2O. However, heavy sedation or even paralysis are frequently used     to ensure the protective ventilation strategy, both of which are associated with respiratory     muscles weakness. Maintaining of spontaneous breathing may decrease the need of sedative drug     and improve gas exchange by promoting lung recruitment.      Pressure-targeted mode is the most frequent way of delivering after 48 hours of initiating     MV. Three types of pressure-controlled mode are available in intubated patients: Biphasic     Intermittent Positive Airway Pressure (BIPAP), Airway Pressure Release Ventilation (APRV),     and Pressure-Assist Controlled Ventilation (also called BIPAPassist). They are based on     pressure regulation but have the difference in terms of synchronization between the patient     and the ventilator. The different working principle of these modes may result in different     breathing pattern and consequently different in tidal volume and transpulmonary pressure,     which may be potentially harmful. The investigators bench study with a lung model     demonstrated higher tidal volume and transpulmonary pressure with the BIPAPassist over APRV     despite similar pressure settings and patient's simulated effort. However, the impact of each     mode on the delivered tidal volume and the transpulmonary pressure in spontaneously breathing     mechanically ventilated patients is currently unknown. Their hypothesis is that when the     investigators compare the three pressure-controlled modes, the asynchronous mode (APRV) will     result in more protective ventilation strategy over the two other modes (BIPAP and     BIPAPassist).   "
92812|NCT02071264|"     This study will implement a socio-behavioral intervention in Quezon City, the Philippines,     using a community-based participatory approach. The intervention involves 1-2 psychosocial     and health education training workshops for the establishment managers and their workers,     focusing on HIV/AIDS risk reduction information and condom use and condom negotiation     skill-building. Participants will also be invited to do dream-building activities that     explore their personal goals and goals for their organization of peers.   "
92813|NCT02071251|"     Approximately 500,000 surgical site infections occur annually in the US. These lead to worse     patient quality of life, more outpatient and emergency room visits, readmissions and home     services, with an estimated increase in costs of at least $3500 per complication. Surgical     site infections are associated with increasing body mass index. There is limited and     conflicting data of the utility of multiple surgical interventions to decrease the risk of     surgical site complications. The investigators explored the effect of a prospective care     pathway for closure of vertical abdominal wounds on patient's wound complications.   "
92814|NCT02071238|"     Understanding of an operation and its risks has been shown to give patients more realistic     expectations, increase cooperation and result in higher satisfaction. Traditionally, informed     consent for surgical procedures involve a discussion between the surgeon and the patient, but     many patients easily forget the details of these talks. The investigators wish to investigate     if providing a written pamphlet along with the standard oral discussion improves patients'     ability to remember the details of the operation, improving the quality of the informed     consent process.      In addition, we will test whether a group consultation format provides a model for     large-volume, low-variation, low-urgency surgery without reducing ability to recall risks of     surgery or overall satisfaction.   "
92815|NCT02071225|"     This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine     treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL).     Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous     (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6     months, and participant follow-up will last 2 years.   "
92816|NCT02071212|"     The purpose of this study is to investigate the potential acute and chronic effect of     ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of     interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects     with an indication for coronary angiography (CA) with or without percutaneous coronary     intervention (PCI) will be included, and a 30-day CHRONIC period where approximately 60     subjects that will undergo PCI will be included and studied (refer to Section 3 'Study Plan     and Procedures'). The primary objective of this study is to compare ticagrelor versus     clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours after     the loading dose of each regimen, in eligible subjects with CAD.   "
92817|NCT02071199|"     The purpose of this study is to evaluate the safety of oral topical application of     Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis   "
92818|NCT02071186|"     The purpose of this study is to test the hypothesis that cognitive remediation and virtual     reality treatment approaches can enhance cognitive and motor function in children with ADHD.   "
92819|NCT02071173|"     The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety,     performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the     RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market     submission. Additionally, data from this study will be used to support post-market approval     requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.   "
92820|NCT02071160|"     The aim of this study is to examine the effect of combining melatonin to whole body cooling     on the brain injury and outcome of neonates following perinatal asphyxia.   "
92821|NCT02071147|"     Purpose:      To examine the safety of omitting the routine postoperative eye clinic review following     phacoemulsification cataract surgery.      Background:      Approximately 300000 cataract extractions are performed annually in the NHS in England,     requiring a similar number of post-operative visits, the majority of which result in no     change in management. A conservative estimate of 70% of visits being unnecessary suggests a     potential saving to the NHS of approximately £10M annually.      What's involved:      The study involves some questionnaires during the duration of the study. These include     questionnaires relating to the quality of life of the patient (conducted before the     operation, and at the 3 month research clinic) and a patient satisfaction questionnaire.     There is also a research clinic 3 months following the operation.      What are the risks/benefits:      There are no real personal benefits to patients on the trial. The trial aims to provide very     important information regarding the safety of discharging patients immediately after surgery.     However the trial could potentially save many thousands of unnecessary hospital visits each     year.   "
92822|NCT02071134|"     The purpose of this registry is to compile characteristics of world-wide outcomes for the use     of Boston Scientific's commercially available Vercise DBS system in the treatment of     Parkinson's disease.   "
92856|NCT02070692|"     The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal     bleeding in women who are using the Etonogestrel contraceptive implant.   "
92825|NCT02071095|"     This study involves researching new approaches to treating HIV infection. Currently, HIV     infection is treated with combinations of drugs called antiretrovirals. These drugs protect     cells from infection by interfering with the viruses' ability to make copies of itself by     infecting new target cells. Though these drugs are very effective, they cannot cure HIV     infection and must be taken each and every day at prescribed doses to maintain their     beneficial effect. This research study is investigating a new approach that involves an     addition to existing medications.      The study is investigating a medication called Poly-ICLC (Hiltonol®, Oncovir), which is an     adjuvant. Adjuvants are medications that are designed to boost your body's immune responses     resulting from a vaccine. The investigators want to test whether Poly-ICLC is an adjuvant     that is effective in HIV-infected patients. A vaccine is not given in this study, but just     investigating the adjuvant, Poly-ICLC, to determine whether it may be safe and useful in     future vaccines that could be used to treat HIV, called therapeutic vaccines. One goal of     future therapeutic vaccines is to reduce the virus that remains persistently inside of cells     in a dormant or resting state despite treatment with HIV medications. This persistent pool is     termed the latent virus pool or viral reservoir. One tactic to reduce this viral     reservoir is to first stimulate HIV to start replicating in order to force it out of hiding.     Once viral replication occurs, the infected cells may then be recognized and killed by cells     of the immune system. Therefore, we also want to see what effect Poly-ICLC has on the virus     that lives inside of cells. Specifically, the investigators want to look at whether Poly-ICLC     increases the level of virus inside your cells while also improving your immune system's     responses.      The investigators are doing this research in hope to find new ways to treat HIV infection     that may reduce exposure to medications that are called antiretrovirals. Antiretrovirals are     medications used to treat HIV infection. They are very effective but have side effects and     have to be taken each and every day and cannot cure HIV.   "
92826|NCT02071082|"     This study will assess the efficacy, safety, and tolerability of     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose     combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected     adults.      Participants will be enrolled into two cohorts:        -  Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive        -  Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed   "
92827|NCT02071069|"     1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab          combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and          fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.        2. The relevant phase III studies reported that the progression free-survival of cetuximab          combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.      This study assumed that the progression free-survival was 5.1 months which was not inferior     to the continuous chemotherapy   "
92828|NCT02071056|"     The purpose of this study is to learn whether the DNA from cancer tumor cells can be found in     the cerebral spinal fluid (CSF) that bathes the brain and spinal cord of patients before     malignant the cancer cells themselves are able to be found in the CSF. The researchers doing     this study hope this information can be used to develop a way to diagnose LM earlier .   "
92829|NCT02071043|"     Gastric cancer with para-aortic lymph node (PAN) involvement is regarded as advanced disease,     and only chemotherapy is recommended from the guidelines. In unresectable cases, neoadjuvant     chemotherapy could prolong survival if conversion to resectability could be achieved.   "
92830|NCT02071030|"     The purpose of this study is to evaluate the efficacy and cost-effectiveness of Cone Beam     Computed Tomography (CBCT) compared to panoramic radiography prior to removal of third molars     in reducing patient's morbidity. Adults having a close relationship between the mandibular     canal and one or both lower third molars, as diagnosed from digital panoramic radiographs     will be recruited for this randomised controlled trial. In one trial arm, patients will     receive the standard digital panoramic radiograph prior to third molar surgery. In the second     arm, subjects will undergo an additional Cone Beam Computed Tomography (CBCT) prior to third     molar surgery.      All patients require a postoperative visit one week after surgery to assess the outcome.   "
92831|NCT02071017|"     Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high     grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last     half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can     provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging     (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the     simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially     presented with brain tumors, and predict the prognosis in the patients diagnosed with primary     high graded astrocytoma or oligodendroglioma.   "
92832|NCT02071004|"     This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in     healthy male and female subjects. It is hypothesized that co-administering DS-1040b with     aspirin at steady state will be safe and well tolerated by healthy male and female subjects.   "
92833|NCT02070991|"     Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of     subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left     ventricular dysfunction.   "
92834|NCT02070978|"     This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II     core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of     atacicept in subjects with systemic lupus erythematosus (SLE). The Week 24 visit of ADDRESS     II core trial will coincide with the Day 1 visit of this LTE trial.   "
92835|NCT02070965|"     The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA     (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily     for 15 days.   "
92836|NCT02070952|"     The purpose of this study is to determine the side effects and how effective CyberKnife     stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The     CyberKnife system is a new type of radiation machine that uses a special system to precisely     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be     minimal. The purpose of this evaluation is to see if this treatment will help patients with     low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the     patients' quality of life over time.   "
92837|NCT02070939|"     This single and multiple ascending dose study is the first evaluation of PF-0626414, a     Selective Androgen Receptor Modulator in humans. The goal is to assess the safety,     tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male     subjects .   "
92838|NCT02070926|"     The CRONOS-ADM (Coronary CT angiography evaluation for clinical outcomes in asymptomatic     patients with type 2 diabetes mellitus) registry is a large, prospective observational     registry of demographic, clinical and laboratory data with long-term clinical outcome of     asymptomatic diabetic patients without history of CAD or angina or angina-equivalent symptoms     at two affiliated hospitals of The Catholic University of Korea.   "
92842|NCT02070874|"     Patients in isolated rural settings often lack easy access to pain care and specialist     services. Yet rural residents are more likely than their urban counterparts to be older; be     in poorer overall health; suffer from more chronic or serious illnesses and disabilities; be     uninsured or underinsured; and live in poverty. Telehealth is an emerging method of health     care delivery that has been found useful and effective in many clinical settings and     specialties. Telehealth technologies can bridge geographic distance and increase access to     specialist care in rural settings. The investigators propose a cluster randomized clinical     trial design to test the effects of a telehealth-enhanced palliative care pain-management     program for 240 patients and 40 providers in rural health care settings. The proposed program     will provide services to both patients and providers: Patients will conduct self-assessments     and report pain and other symptoms via telehealth. Health care providers will receive     telehealth-delivered case consultations that will include case management, evidence-based     practice resources, and peer support. Providers and their patients will be randomly assigned     to intervention groups, which receive the telehealth-enhanced palliative care pain-management     intervention, or to control groups. The investigators primary aim is to compare patient     self-reports of pain and quality of life in the intervention and control groups over 2     months. Aim 2 is to examine, in the intervention and control groups over 2 months, providers'     knowledge and attitudes regarding pain and perceived competence in treating pain. Aim 3 is to     evaluate the cost-effectiveness of the telehealth intervention. The investigators will use     mixed effects models with patients nested within providers to evaluate the effect of the     intervention on study outcomes. Findings from this study will be instrumental in advancing     telehealth and improving pain management and palliative care among underserved rural     populations.   "
92843|NCT02070861|"     The investigators hypothesize that exhaled CO2 reflect changes in blood circulation due to     changes in lung circulation, provided CO2-production in the tissues and ventilation from the     lungs are stable. The investigators want to investigate this in patients using different     devices: a finger cuff measuring blood pressure and cardiac output (the amount of blood being     pumped out of the heart each minute), an esophagus ultra sound device measuring cardiac     output, and exhaled carbondioxide in the patients` breath measured by the ventilator.      The investigators investigate patients undergoing bypass surgery on the heart, as they     undergo relevant changes in blood circulation during their operation.   "
92844|NCT02070848|"     Physical exercise triggers various physiological responses including a marked increase in     muscle blood flow and oxygen delivery in order to support muscle activity. How muscle blood     flow is controlled is currently unclear.      The primary purpose of this study is to establish the respective contribution of metabolic     (linked to energy requirements) and mechanical (linked to muscle tensions) signals in the     exercise hyperemia and the possible role of the red blood cells.      Vasodilation and muscle blood flow during exercise are controlled by ATP released in the     plasma from the red blood cells in response to a combination of metabolic and mechanical     signals applied on the vasculature.   "
92845|NCT02070835|"     Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in     clinical practice. This study was conducted to have a prospective, randomised, controlled     study compare the safety and efficacy of the ReCell® technology with skin graft (experiment     group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot     ulcers.   "
92846|NCT02070822|"     This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to     evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will be     recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the tumor     responses. After day 28, all subjects will receive standard clinical care and be follow-up     for 1 year. The imaging parameters will be compared among each MRI and correlate with     patients' outcome. The investigators hypothesis that it might be helpful to combine DCE-MRI,     DWI, and MRS for assessment of tumor response after TACE and predict patients' prognosis.   "
92847|NCT02070809|"     A wound comprises a break in epithelial continuity and disruption of structure and function     of underlying tissues, the treating and repairing is always a great challenge in clinical     practice. The complex healing process make the wound easy to get a tendency of nonhealing and     result in a heavy burden of life quality. Nowadays surgical repairing is still the main     method, but there was still no effective and satisfy outcomes. Because none of the treatments     could repair skin both on structure and function. Now the investigators provide a quick and     effective method to rebuilt complete structure and function of the skin based on     tissue-engineered skin technology. To further test the efficacy and safety of this new     method, the investigators propose a prospective randomized controlled multicenter trial to     compare this method with traditional skin graft.   "
92848|NCT02070796|"     The primary objective of the study is to establish Bioequivalence (BE) of 2 different     formulations of the 2 mg/24 hr (10 cm^2) Rotigotine transdermal patches in Chinese subjects.   "
92849|NCT02070783|"     Studies on the hormone Erythropoietin (EPO) have indicated that EPO may have antidepressant     properties. However, EPO may cause serious side-effects with repeated administration     (thrombosis), which limits its usefulness as an antidepressant. ARA290 is a peptide that does     not have the effects of EPO on blood cells but may still have its effect on brain function.     In an attempt to replicate previous findings with (a single dose of) EPO in healthy     volunteers, we study the effects of ARA290 on the cognitive and neural processing of emotions     in healthy volunteers. We hypothesize that a single dose of ARA290 will lead to a positive     shift in information processing compared to placebo, 7 days post-administration.   "
92850|NCT02070770|"     The purpose of this study is to determine whether short-term adherence to a very low calorie     diet is effective in improving heart rate variability in obese individuals.   "
92851|NCT02070757|"     This is a phase 3, multicenter, prospective, randomized study of intravenous (IV)     ceftolozane/tazobactam vs. IV meropenem in the treatment of adult participants with either     ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial     pneumonia (HABP).   "
92852|NCT02070744|"     The objective of this study is to evaluate the safety and efficacy of VX-661in combination     with ivacaftor in subjects with cystic fibrosis (CF) who are homozygous for F508del CFTR     (cystic fibrosis transmembrane conductance regulator) mutation   "
92853|NCT02070731|"     A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter     aortic valve implantation.   "
92854|NCT02070718|"     Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs)     may affect thermoregulation. This pilot study has the aim to establish proof of concept     regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.   "
92857|NCT02070679|"     The purpose of this study is to evaluate the effect of vitamin E on preventing from incidence     of contrast induced acute kidney injury (CI-AKI) in the patients who undergone coronary     angiography.   "
92976|NCT02069106|"     Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with     mixed hyperlipoproteinemia.   "
92862|NCT02070614|"     This study was designed for exploring the association of cytochrome P450 3A4 rs2242480     polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal     surgery，to provide evidence for genetic prediction of personalized medication.Methods:60     patients who prepared for elective upper abdominal surgery under general anesthesia were     recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480     genotyping was carried out by direct sequencing. The blood samples were drawn before     anesthesia，30 min and 45min after anesthesia respectively，used for plasma sufentanil     concentration detection with high performance liquid chromatography-mass spectrometry     (HPLC-MS). After surgery，the patients received patient-controlled intravenous sufentanil     immediately. And postoperative pain at rest，sufentanil consumption，side effects and rescue     analgesic requirements were recorded at the 6th，12th，24th hour. The plasma sufentanil     concentration and PCA sufentanil consumption were analyzed to investigate the differences     among rs2242480 three genotypes.   "
92863|NCT02070588|"     This feasibility study is being conducted to determine potential associations between a broad     range of clinical neurological symptoms and magnetic resonance images (MRI), data, and     clinical findings involved in mild traumatic brain injury (mTBI).      These associations will be examined over the acute and sub-acute period (approximately 3     months) following injury to provide information useful for optimization of MR pulse sequences     for mTBI applications.      Correlations exist over the sub-acute period in clinical neurological and MR data (images,     image reads, and RAW data), which may indicate temporal evolution patterns. The intent of     this study is to broadly generate potential biomarkers of temporal evolution of mTBI     detectable in MR images and data (MR mTBI biomarkers).   "
92864|NCT02070575|"     The purpose of this study is to investigate if a new blood test looking at PSA and a group of     PSA related proteins in a patient's blood can indicate which men after surgery with a rising     PSA could benefit from treatment, and/or indicate which men are at higher risk for recurrence     before initial treatment is given.   "
92865|NCT02070562|"     This study aims to investigate breast milk composition and dietary habits of Chinese     lactating mothers. Further understanding of the composition of human milk will help to     understand the nutritional needs of mothers and their infants in their early phase of life     which eventually will help to support breastfeeding.   "
92866|NCT02070549|"     This phase I trial studies the side effects and best dose of trametinib in treating patients     with cancer that has spread to other places in the body and usually cannot be cured or     controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib     may stop the growth of tumor cells by blocking proteins needed for cell growth. When these     proteins are blocked, the growth of cancer cells may be stopped and the cancer cells will     then die. Hepatic dysfunction is frequently found in patients with advanced cancer and     usually prevents patients from receiving standard treatments or from participating in     clinical trials. Patients may also need dose adjustments or absorb drugs differently.     Trametinib may be a better treatment for patients with advanced cancers and hepatic     dysfunction.   "
92867|NCT02070536|"     Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have     limited positive predictive value. No studies have evaluated predictive kinetics of plasma     biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad     population of critically ill patients or as an adjunct to clinical prediction scores.      The main objective of the investigators study is to evaluate the predictive values of plasma     soluble RAGE levels for the onset of ARDS in a high risk population of patients admitted to     the intensive care unit (ICU).      One of the investigators goals is to improve early identification of patients at risk for     ARDS in order to better implement preventive stategies prior to ARDS development.      The primary outcome is the occurrence of ARDS during the first week after admission to the     ICU.   "
92868|NCT02070523|"     To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD)     inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with     VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether     chemotherapy containing PLD with a higher response rates and greater safety in adult ALL   "
92869|NCT02070510|"     This trial is conducted in Europe. The aim of the trial is to investigate the influence of     oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy     subjects.   "
92870|NCT02070497|"     The study is to investigate the effectiveness of nursing case management for lung cancer     patients in a Taiwan medical center.   "
92871|NCT02070484|"     The purpose of this study is to compare the effect and safety of NuCel to DBX on patients     undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.   "
92873|NCT02070458|"     This phase I trial studies the side effects and best dose of ixazomib when given in     combination with mitoxantrone hydrochloride, etoposide, and intermediate-dose cytarabine in     treating patients with acute myeloid leukemia that is unresponsive to initial induction     chemotherapy or recurs following an initial complete remission. Acute myeloid leukemia is a     cancer of the bone marrow cells; bone marrow is where blood cells are normally made. Ixazomib     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, and     intermediate-dose cytarabine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Mitoxantrone hydrochloride,     etoposide, and intermediate-dose cytarabine are standard treatment for relapsed or refractory     acute myeloid leukemia. Giving ixazomib with mitoxantrone hydrochloride, etoposide, and     intermediate-dose cytarabine may improve the effectiveness of the chemotherapy.   "
92945|NCT02069509|"     This is a multi-centre, multi-national, prospective, observational study of Friedreich's     Ataxia (FRDA) with a control group to:        -  obtain natural history data on individuals affected by FRDA        -  relate clinical assessments and results from proteomic analyses        -  expedite identification and recruitment of participants for clinical trials        -  develop and validate sensitive and reliable outcome measures for detecting onset and          change over the natural course of FRDA which may also be potential outcome measures for          use in future clinical trials and clinical care        -  plan for future research studies   "
92977|NCT02069093|"     Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in     Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer   "
92978|NCT02069080|"     In mouse models and in patients, expression of the chemokine receptor CXCR4 on various     cancers has been correlated with aggressive biological behavior, including increased rates     and certain sites of metastasis, and decreased survival. Plerixafor (Mozobil ; Genzyme;     Cambridge, MA) has been identified as a specific inhibitor of CXCR4, and it is currently     approved by the Food and Drug Administration as a stem-cell mobilizing agent in combination     with granulocyte colony-stimulating factor in the treatment of non-Hodgkin's lymphoma and     multiple myeloma. Our group has recently shown that plerixafor can be labeled with the     positron-emitting radionuclide copper-64((64)Cu) to form (64)Cu-plerixafor, which can be used     to visualize CXCR4-positive tumor xenografts in mice using small-animal positron emission     tomography (PET). Determining CXCR4 expression in tumors using (64)Cu-plerixafor and     PET/computerized tomography (CT) scanning could be useful in predicting tumor behavior and     responses to current and experimental therapies, including therapies targeting CXCR4, which     could lead to more effective personalized cancer treatments.      This study s primary objective is to evaluate (64)Cu-plerixafor as an imaging agent for     quantifying CXCR4 expression in subjects (greater than or equal to 18 years of age) with     cancer; at least 1 detectable solid tumor of greater than or equal to 2 cm in diameter found     outside of the lymph nodes, bone marrow, liver, gallbladder, kidney, bladder, and brain; and     preexisting biopsies of the tumors obtained since the first detection of the current     occurrence/recurrence of disease. The secondary objectives are to correlate (64)Cu-plerixafor     standardized uptake value in the target lesion with the level of CXCR4 expression detected     via immunohistochemistry and to calculate human dosimetry for (64)Cu-plerixafor.      Preexisting tumor biopsies from less than or equal to 75 subjects recruited from the National     Cancer Institute and the Georgetown University Hospital will be evaluated for CXCR4     expression via immunohistochemistry. Subjects who meet the eligibility criteria will continue     onto the study. Five subjects with CXCR4-positive tumor biopsies will be administered an     initial intravenous infusion of (64)Cu-plerixafor (8 +/-0.8 mCi ; 0.48+/- 0.048 rem; not to     exceed 5 microg of (64)Cu -plerixafor) over 2 minutes. They will then undergo an initial     low-dose transmission CT scan followed by 3 consecutive torso PET scans as soon as practical     after the infusion, and 2 additional PET/CT scans at 4 hours +/- 1 hour and 24 hours +/- 2     hours post-infusion. Human dosimetry will be calculated based on these results, and a maximum     dose will be used, not to exceed the calculated limit of a total effective dose of 5 rem, or     the radiation exposure limit for each organ. The remaining subjects with CXCR4-positive     (n=15) and CXCR4-negative (n=5) tumor biopsies will be administered 64Cu-plerixafor at the     same, or a newly calculated dose, and will undergo 1 PET/CT scan between 1 and 4 hours     post-infusion, depending on the dosimetry results. All subjects will undergo one     comprehensive final study visit between study days 19 and 23 (11-17 days after injection with     (64)Cu -plerixafor). Additionally, blood will be collected 2 more times between study days     13-16 and study days 26-30 to measure blood cell counts.   "
92874|NCT02070445|"     During most types of heart surgery cardiopulmonary bypass (CPB) is used. CPB enables blood to     be directed away from the heart and the lungs and pumped through the body while the heart is     not beating. Surgery on the heart easier when it is not beating and bloodless area. Generally     during CPB the lungs do not need to be ventilated, as no blood is flowing through the lungs     and the body received oxygen from a machine (oxygenator) attached to the CPB pump.      In this study we are investigating the difference in lung collapse after heart surgery in     patient who did have their lungs ventilated during CPB, compared to patients who did not have     their lungs ventilated during CPB. We will use lung ultrasound scans to determine the degree     of lung collapse at various time periods before and after the heart surgery. We will also     investigate if ventilation during CPB will affect: a.) the rate of lung infection or     pneumonia after the operation b.) the time it takes for a patient to have the breathing tube     removed in the intensive care unit after the operation c.) the time for a patient to be     discharged home from the hospital d.) the concentration of oxygen in the blood after the     operation.   "
92875|NCT02070432|"     This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11     following photodynamic therapy (PDT) of patients with advanced head and neck cancer.   "
92876|NCT02070419|"     This randomized phase II trial studies how well transarterial chemoembolization (TACE) works     compared with TACE plus radiation therapy in treating patients with end stage liver disease,     liver tumors, or potential liver transplant candidates. TACE involves reaching up to the     blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the     physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and     the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and     stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a     type of radiation therapy that delivers radiation to the tumor cells but does not harm normal     liver cells. It is not yet known whether TACE is more effective with or without SBRT in     treating liver tumors.   "
92877|NCT02070406|"     This pilot phase I trial studies the side effects of taking ipilimumab after gene-modified T     cells and vaccine therapy when treating patients with advanced cancer that has spread to     other areas of the body and has not responded to standard therapies. This trial also will     determine the best dose of Ipilimumab to use in this combination treatment. T cells are a     special type of white blood cell (immune cell) that have the ability to kill cancer cells. T     cells are taken from the blood and modified in the laboratory to recognize a specific protein     expressed on cancer cells, called NY-ESO-1. This may allow the T cells to target and kill     cancer cells that express that protein. Dendritic cells are another type of blood cell that     can teach other cells in the body to look for cancer cells and attack them. Giving a     dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune     system to target cancer cells expressing that protein, and further help the T cells attack     cancer. Ipilimumab is a monoclonal antibody, a type of drug manufactured in the laboratory     that is similar to antibodies made in the human body that fight off infection. Ipilimumab     blocks a protein that turns down the immune system, so blocking this protein may make the     immune system more active. This may increase the ability of immune cells to kill cancer cells     and improve the effectiveness of the T cell transplant. Giving gene-modified T-cells, a     dendritic cell vaccine, and ipilimumab together may teach the immune system to recognize and     kill cancer cells that have the NY-ESO-1 protein.   "
92878|NCT02070393|"     The purpose of this study is to drastically reduce unnecessary breast dose in young females     with Hodgkin's Disease who require radiation therapy.   "
92879|NCT02070380|"     This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg     and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of     MultiHance.   "
92880|NCT02070367|"     This pilot study will test a new therapy, somatosensory rehabilitation, for the painful     sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome     (CRPS). Several methods for measuring pain and sensitivity that emphasize the person's     evaluation of their own symptoms and the impact of these symptoms on their daily activities     will also be tested to make sure they are consistent and accurate.      Previous research has suggested one of the assessments may also be used to assist in the     identification of CRPS: this simple test will be evaluated to see if it can accurately     identify persons with this disorder (for which there is currently no diagnostic test).     Together, this will improve treatment of CRPS through early, accurate diagnosis and the     ability to measure important changes in this painful condition, and set up future studies for     this new rehabilitation treatment method.   "
92881|NCT02070354|"     The purpose of this research study is to determine how bariatric surgery affects physical     activity and nutrient intake.      This research study is being done because the investigators want to determine better     recommendations to provide to bariatric surgery patients.   "
92912|NCT02069938|"     Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual     and physical objects through the voluntary modulation of brain rhythms. Current issues with     noninvasive BCIs include exhausting motor imagery tasks and long training times required to     achieve competent control. The investigators will address these issues within this protocol,     examining new approaches to reduce the effort required by subjects to control a physical     object in the task.      The PI's hypothesis is: Control of a physical robotic device will increase the performance of     subjects in BCI tasks that are analogous to virtual tasks due to greater engagement with a     physical output.   "
92946|NCT02069496|"     This post-marketing surveillance study is designed to collect safety information such as     post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1)     Intramuscular Injection.      The following items will be investigated as priority investigation items. <Priority     investigation items>        1. Allergic reactions        2. Anaphylaxis   "
92947|NCT02069483|"     Smokers who are not actively engaged in quitting will participate in a study using     self-generated text and audio text messages containing reasons to quit smoking.   "
92963|NCT02069275|"     The purpose of this study is to investigate the frequency of bleeding and haematomas in     patients undergoing coronary angiography or percutaneous coronary intervention via femoral     artery and mobilized immediately after the procedure, compared to those mobilized after two     hours (following the standard regimen). At the same time the investigators will investigate     whether it reduces the discomfort being mobilized immediately after the procedure.   "
92882|NCT02070341|"     Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon     cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation     administration is now recognized as an important component for achieving superior cleansing.     Multiple randomized controlled trials and meta-analyses have found split-dosing to be     superior than day-before dosing. Objective: This study aims to compare two types of bowel     preparations in split-doses to assess for differences in patient tolerability, as well as     efficacy of colon cleansing. Methods: This is a prospective, single-blinded,     randomized-controlled trial. Patients who are being referred for a colonoscopy will be     recruited to participate in the study. They will be randomly assigned to receive either a     split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient     tolerability will be examined through questionnaires. The endoscopist performing the     colonoscopy will use two standardized bowel preparation scoring systems to evaluate the     quality of the cleansing. The investigators propose that P/MC will be superior to PEG in     patient tolerability and non-inferior in bowel cleansing effects.   "
92883|NCT02070328|"     Proton therapy is a limited medical resource that is more expensive than conventional x-ray     therapy. To correctly measure the success of proton therapy in treating different conditions,     it is important to check a patient's health status after their treatment is finished.     Checking on the progress of patients over many years (called long-term follow-up) is needed     because the long-term effects of proton therapy are not well known.   "
92884|NCT02070315|"     Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM     Elastography may provide a non-invasive, fast, and reproducible alternative for the     quantitative assessment of liver fibrosis.   "
92885|NCT02070302|"     This study will be a prospective double blind controlled randomized trial of ten patients     diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of     medical practices in Arizona. Patients who meet inclusion criteria will be randomly     distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal     Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned     individuals.   "
92886|NCT02070289|"     The purpose of this study is to investigate safety, toleration and time course of plasma     concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two     age groups, 18-55 years (Group 1) and 56-75 years (Group 2).   "
92887|NCT02070276|"     Spinal anesthesia is still the regional anesthesia technique most widely employed in everyday     clinical practice.      The most feared and common of its well known side effects consist in an abrupt reduction of     systemic vascular resistances, with consequence risk of systemic hypotension. To prevent this     potentially severe complication, an adequate correction of patients' volume status through a     preventive administration of fluids is widely used.      However this volume repletion is commonly accomplished on an empirical basis, without having     a real insight of patient hemodynamic status, carrying the risk of possible volume overload.      Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide     volemic repletion before spinal anesthesia on the reduction of significant hypotension rate,     compared to empirical fluid administration.   "
92888|NCT02070263|"     The purpose of this prospective study is twofold: 1) to establish oral tolerance to selected     tree nuts and to examine potential predictors of oral tolerance and 2) to determine the     usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut     allergy and oral tolerance.   "
92889|NCT02070250|"     Psychological interventions for cancer patients have been tested and found to reduce stress     and improve quality of life. These interventions have been tested at academic medical centers     but have not been available for use by community mental health professionals. One such     intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L.     Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to     train mental health professionals from across the country to deliver the BBI at their     institution. Recently diagnosed cancer patients who are participating in the BBI group at     these institutions may participate in a research study completing self report measures asking     about psychological and behavioral outcomes (for example, mood, stress, diet and physical     activity). The investigators hypothesize that individuals participating in the intervention     will report improvements in outcomes, such as reduced stress and improved mood, reduced     symptoms of the disease and treatment, etc., after completing the intervention and continue     to report these improvements up to 6 months after the group ends. OSU will coordinate this     data collection project but information about participating sites is listed in     http://clinicaltrials.gov.   "
92890|NCT02070237|"     Pregnant and recently postpartum women are at significantly higher risk of developing a blood     clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot in     their lungs known as a pulmonary embolism (PE) compared to their non pregnant counterparts.     It is estimated that this risk increases anywhere from 4 to 50 times higher in pregnant     versus non-pregnant women and further increases almost 11 fold in the post partum period.     This risk is almost doubled when the patient undergoes cesarean delivery. In 2011, the     American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines stating     that for patients undergoing cesarean delivery with additional risk factors for clot or     thromboembolism, protective (prophylactic) treatment with low molecular weight heparin (LMWH)     a type of blood thinner should be considered. However, no specific guidelines about which     risk factors should be considered, or what medication doses should be used were provided. The     American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines     published in 2012 delineated who should be given prophylaxis based on various risk factors,     however acknowledged that the recommendations were based on weak quality evidence.      ACOG endorses either once or twice a day dosing for high risk patients after delivery and     states that adjustments for obese women should be made on a case by case basis. However,     there are limited studies on the dosing of LMWH in specific subpopulations including post     operative patients, pregnant patients and obese patients. All of these studies have urged     further investigation of the correct dosing for these high risk subjects due to changes     associated with pregnancy and the level of medication in the blood that may put these     patients at higher risk of venous thromboembolism. Many previous studies have shown that     women in these high risk categories do not achieve protective levels of the medication     measured with a laboratory test; anti Xa level. The investigators hypothesize that due to     their dual risk, obese post-operative recently pregnant women may not be adequately protected     with the daily fixed dose and might need more frequent dosing to protect them.      The objective of this study is to assess what proportion of women achieve the desired anti Xa     level with the fixed daily dose versus twice daily weight based dosing (0.5 mg/kg).   "
92891|NCT02070224|"     The purposes of this study are to assess the prognostic value of serum and urinary biomarkers     Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression     of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis     clinical score at 12 months. Additionally, this study will search for correlations between     serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI     and clinical severity of knee osteoarthritis.   "
92893|NCT02070198|"     Despite the progression in assisted reproductive technology (ART), poor ovarian response to     controlled ovarian stimulation remains a challenge for clinicians and a source of distress     for patients. Multiple strategies have been tried to overcome these obstacles. The increase     of the gonadotropin administration have been associated with a very low pregnancy rate. The     introduction of GnRH agonist protocol, which takes advantage of the initial rise in     endogenous gonadotropins that follows the agonist administration in the early follicular     phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have     improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were     introduced in ART treatment. They are effective in preventing a premature LH surge and allow     for a more natural recruitment of follicles in the follicular phase in a non suppressed     ovary. However, the randomized studies comparing the efficacy of these two regimens reported     conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH     such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal     testosterone failed to improve IVF outcomes. Recently, the new treatment option with     corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary to     support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems to     have a potential beneficial effect in poor responders.      The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH     antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .   "
92894|NCT02070185|"     The main objective is to study, in 8-11 year old children, the influence of energy density     conditioning on liking for new flavored beverages and on caloric adjustment after the     beverage consumption. The stability of the energy conditioning was evaluated after a period     without exposure and after an extinction period during which the energy density of the     beverages was changed.   "
92895|NCT02070172|"     Motion limitations have been previously reported in people with headaches originating from     the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been     found useful to diagnose this type of headache. This observational study investigates this     neck motion test when performed actively by the patient and passively by the examiner, then     compares the results of motion attained.   "
92896|NCT02070159|"     Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent     platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested     especially in East Asian ethnicities. The investigators compared the effect of lower loading     dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.   "
92897|NCT02070146|"     Survival after colorectal cancer (CRC) diagnosis strongly depends on local tumor extent,     lymph node involvement and the presence of distant metastases. However, there remains great     inter-patient variability regarding treatment outcome. A combination of biochemical factors,     histopathological features, genomic profile, environmental factors and other clinical factors     are likely to influence prognosis and treatment effect, independent from tumor stage, but it     is still unclear which, how, and to what extent these factors can influence tumor recurrence     and mortality in both early stage (I-III) and late stage (IV) CRC.      Although the results from prospective clinical trials will remain the backbone of evidence     based medicine, this concerns a highly selected patient population since the large majority     (85%-95%) of cancer patients do not participate in clinical trials for various reasons. It is     unlikely that trial participation will significantly improve in the near future. This fact     has the following implications: 1) It is highly desirable to validate the results from trials     in the general patient population. However, this is complicated by the fact that the     documentation of patients treated in general practice (i.e. outside the scope of clinical     trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic     characteristics and treatment parameters. 2) There is an increased availability of novel     technologies that provide molecular markers with potential prognostic and/or predictive     value. To test the clinical value of these markers large numbers of patients are required     which greatly exceeds the number of patients who consent to participate in prospective     clinical trials. 3) as a result of rapid technical developments, a range of new minimally     invasive treatment options for CRC are entering the market. These interventions have the     potential to be of great benefit for patients in terms of improved local control, higher     probability of complete tumor removal, less damage to surrounding tissue, faster recovery and     less short and long term side effects. Still, the interventions will have to prove their     effectiveness, safety and superiority (or non-inferiority) to standard cancer treatments on a     patient level. A prospective observational cohort study has the great opportunity to fill     this gap.   "
92898|NCT02070133|"     To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy     of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B:     body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric     acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind,     placebo control study. Population: 18 males with stable COPD between 40-80 years of age,     exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted     post-bronchodilation.   "
92899|NCT02070120|"     Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of     frequent low grade recurrence, which usually necessitates surgical intervention under general     anaesthetic. This multicentre study aims to establish the short term efficacy of     chemoresection using chemotherapy within the bladder for the treatment of NMIBC.      Should the levels of complete response following chemoresection meet predefined criteria, a     larger phase III trial would be developed to assess longer term disease related endpoints,     with the aim of standardising management of recurrent low risk NMIBC and potentially removing     the need for over a thousand patients each year to undergo surgery.   "
92900|NCT02070107|"     No more than 56% of subjects at the Robley Rex Louisville Veterans Administration Medical     Center (VAMC) prescribed boceprevir-based triple therapy, will complete Hepatitis C (HCV)     treatment as prescribed. Of patients who did not complete therapy, the primary reasons for     discontinuation were side effects (48%) and non-adherence (32%). An intervention is needed to     improve the treatment completion rate in subjects so they can achieve the high SVR rates     noted in SPRINT-2 and RESPOND-2   "
92901|NCT02070081|"     The overall aim is to study the multiple factors determining the variation of weight loss     after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery.      The specific aims are to evaluate:      a) what explains the large individual differences in weight loss seen after RYGB and Sleeve     surgery, b) if it is possible pre-operatively to identify which patients will not obtain     beneficial effects of bariatric surgery in relation to weight loss and quality of life and c)     if patients in need of improved care can be identified pre- and/or early post-operatively.   "
93117|NCT02067273|"     The purpose of this pilot study is to test the durability of response to Transcranial     Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The     investigators will test various methods of TMS for varying lengths of time in a pilot study     to investigate what the clinical impact.   "
92902|NCT02070068|"     Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed     abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is     the most common of these with more than 750,000 performed annually. Injury to the common bile     duct (CBD) during these procedures occur infrequently (approximately 0.1% to 0.5%), but it is     an important source of patient morbidity. Serious injuries often require at least one     surgical repair, and these repairs have variable long-term outcomes. Techniques to allow the     visualization of the bile ducts may prevent such an injury, by providing vital information     about the presence of gallstones in the CBD and show a surgical road map of the ducts.     Near-infrared (NIR) cholangiography has the advantage over standard cholangiography of not     exposing patients and healthcare providers to radiation. This technique also allows the     superimposition of the cholangiogram onto the normal image.      This study is being conducted to optimize an imaging technique called PINPOINT. Images will     be obtained during clinically necessary operations. The images will be evaluated to determine     the best method for locating and outlining the anatomy. The information learned will guide     the future use of PINPOINT in laparoscopic procedures.   "
92903|NCT02070055|"     There is a large variability in people's ability to burn fat during exercise. It is thought     that differences in dietary intake can partly explain this variation, however this has not     been comprehensively studied. This will be investigated by measuring participant's habitual     diet and rates of fat oxidation during exercise, and look for associations between the two.   "
92904|NCT02070042|"     We aim to evaluate whether the addition of Omega-3 fatty acids to oxybutynin, a standard     first-line treatment for overactive bladder syndrome, will improve symptoms and quality of     life. Secondarily, we will evaluate whether Omega-3 fatty acids help reduce the adverse     effects of oxybutynin.      Hypothesis        -  Primary: Omega-3 will enhance the beneficial role of oxybutynin in the treatment of          overactive bladder (OAB)        -  Secondary: Omega-3 will reduce the side effects of dry eyes and constipation associated          with oxybutynin   "
92905|NCT02070029|"     Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and     Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized     treatment for this condition. We know that alternative therapies such as acupuncture have     been beneficial to women suffering from urinary incontinence, chronic lower back pain, and     migraines. We hypothesize that the quality of life for premenopausal women with hypoactive     sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a     duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and     1 week after the final acupuncture session as the method of analyzing our primary outcome.   "
92906|NCT02070016|"     The purpose of this study is to test whether non-invasive brain stimulation, such as     Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic     pain conditions. We will test various methods of TMS to identify a treatment approach that     may reduce the symptoms of chronic pain for the patient.   "
92907|NCT02070003|"     The investigators aim to characterize the relationship between changes in emotional distress,     opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to     compare the effectiveness of post-surgical motivational interviewing and physician-guided     opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed     research will advance knowledge regarding the role of psychological factors contributing to     persistent opioid use after surgery.   "
92908|NCT02069990|"     Circa-annual variations in 25-hydroxyvitamin D [25(OH)D] levels have been well established,     and there also seems to be an effect of season on bone turnover and bone mass. been shown     that bone turnover follows a circa-annual rhythm. On the basis of human clinical results, it     was suggested that adipose tissue functions as a vitamin D buffering system that to a certain     extent prevents uncontrolled synthesis of 25(OH)D in the liver. Directly related to this     issue is the question of how much vitamin D is needed to ensure target serum     25-hydroxyvitamin D [25(OH)D] concentrations. According to the recommended dietary     allowances, persons should achieve levels of intake of essential nutrients considered to be     adequate to meet the known nutritional needs of practically all healthy persons Moreover it     is important to note that the significant percentage of the population is temporarily of     continuously deficient in vitamin D. In the similar condition of vitamin D deficiency, the     aetiology is very different since only as almost exclusively as a consequence of a primary     disease in children it is manifested: hypovitaminosis D is highly prevalent among children on     renal substitution therapy, regardless of the type of therapy used and the stage of renal     failure.      The rationale providing high dose strengths of vitamin D based on an assumption of better     compliance especially in adult with senior age patients; also a potential for faster     resolution of vitamin D deficiency, since utilization of cholecalciferol is higher when     patients had low levels of 25(OH)D, and vice versa, there is a plateau phase when close to     normal range (Vieth 2001).      According to clinical data, a doses equivalent of daily 1000 IU, (7000 IU per week, or 30000     IU per month) is considered as a minimal effective dose to treat vitamin D deficiency. The     treatment of vitamin D with a duration of 30 days may result and increase of 6-12.5 nmol/L.     With the deficiency criteria considered as <20 ng/ml, the vitamin supplementation is     indicative, the treatment dosages should be adjusted to the increase planned to achieve the     mid-normal range.      As the base of calculations, the doses of 40 IU results in an increase of 0.4 ng/ml in a     period of 60 days. Accordingly 1000 IU in a period of 2-5 month resulted in an increase of     approx 10 ng/ml. The risk of overdose in relatively low, since the absorption and the     metabolic path is well controlled: automatic mechanisms downregulation at normal ranges.      In this study the there are three groups in the similar daily dose equivalent of 1000 IU/day.     The absorption of daily , weekly and monthly dosing should have a buffered effect due to the     body adipose tissues, balancing the daily 1,25(OH)D levels, and moreover to provide a     biological reservoir. The three doses are considered as comparable in efficacy and safety.      The fourth group is intended to utilize the expanded dose range of 4286 IU/ day, using the     30.000 IU tablets on a weekly dosing schedule. This group is to demonstrate the efficacy of     higher doses to normalize the vitamin D levels, within a reasonable timeframe of 60-90 days.   "
92909|NCT02069977|"     -  To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral          problems in Asian children and adolescents with a diagnosis of autism spectrum disorder,          as measured by change from baseline to endpoint on the irritability subscale of the          aberrant behavior checklist (ABC-I).        -  To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the          treatment of serious behavioral problems in Asian children and adolescents with a          diagnosis of autism spectrum disorder.   "
92910|NCT02069964|"     Some patients with head and neck cancer or benign tumours of the head and neck receive     radiotherapy to their neck as part of their treatment. The large arteries in the neck, the     carotid arteries, are often included in the area being treated with radiotherapy. There is     some evidence to show that radiotherapy to these blood vessels can result in thickening and     furring of the artery walls some years after treatment. This thickening may then result in     stiffening and narrowing of the artery.      Current research is now aimed towards detecting radiotherapy-related changes to the carotid     arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating     these blood vessels if possible. The question of whether or not the use of preventive     medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is     currently unanswered.      The aim of this study is to compare the thickness (intima-medial thickness) of the carotid     artery wall over time (a period of 5 years) following radiotherapy to the thickness in     carotid arteries that have not received radiotherapy. There are many other causes for     thickening of arteries (such as high blood pressure, high cholesterol levels and diabetes)     and these may affect the ability to measure the effect of radiotherapy change to the artery     wall. In order to address this, it is ideal to look at this process in patients who are     having only one side of the neck treated and use the other side as a comparison. The study     will also be investigating for earlier signs of radiotherapy-related changes, such as     stiffening of the artery wall, inflammation in the artery wall (a very early sign of     radiotherapy-related change) and some markers in the blood that may indicate that this     process is taking place.      The null hypotheses of this study are:        -  In irradiated carotid arteries, mean intimal-medial thickness at one year following          radiotherapy will be the same as in unirradiated arteries.        -  The incidence of carotid artery stenosis will be the same in irradiated and unirradiated          carotid arteries        -  Arterial wall strain at one year following radiotherapy will be the same in irradiated          and unirradiated carotid arteries.        -  Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries          during radiotherapy as an early marker of atherosclerosis; microbubble ultrasound will          not demonstrate at what dose of radiotherapy inflammation begins.        -  Serum biomarker levels will not increase over time from baseline after radiotherapy and          won't correlate to IMT and arterial strain.   "
92911|NCT02069951|"     Surgical training programs using virtual reality simulators often only use basic skills     training and the use of procedural training is very limited. Procedural training differs from     basic skills training by requiring integration of isolated skills and decision making and     planning components. However, it is unknown if it is necessary to practice all procedures     before operating on actual patients or whether it is simply a matter of learning psychomotor     skills and if these skills are transferable between different tasks.      The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it     easier to reach proficiency on a different laparoscopic procedure on the simulator because     participants have already practiced the integration of isolated skills.   "
92940|NCT02069574|"     The purpose of the present study is to identify the novel periodontal disease biomarkers     using differentially expressed microRNA in the saliva. The severity of chronic periodontal     diseases and the time of pre- and post-treatment are major classification criteria. The     obtained data will secure the foundation for the development of a new non-invasive diagnostic     methods for early diagnosis & prognosis prediction of periodontal disease.   "
92913|NCT02069925|"     The guiding questions for this study are: can a U.S. adaptation of a successful Scandinavian     approach (TIPS) to early detection substantially reduce the duration of untreated psychosis     (DUP) and improve outcomes beyond an established first-episode service (FES)?      The primary aim of this study is:        1. To determine whether an early detection intervention can reduce DUP in the US, as          compared to usual detection. Early detection (ED) will be implemented in one US          community (New Haven, CT), and usual detection efforts will continue in another (Boston,          MA). DUP will be measured at admission to the corresponding first-episode services (STEP          & PREP) in each community, over one year before and throughout ED implementation. The          investigators hypothesize that DUP will be reduced significantly in the early detection          site compared to the usual detection site;        2. A secondary aim is to determine whether DUP reduction can augment the outcomes of          established FES on outcomes in the U.S. The investigators will measure symptoms,          functioning and engagement with treatment at entry and over 1 year at each site. The          investigators hypothesize that shorter DUP at one FES (STEP) will predict reduced          distress and illness severity at entry and better early outcomes at STEP compared to          PREP.   "
92914|NCT02069912|"     1. Implement an evidence-based structured care approach that includes screening; acute          treatment and relapse prevention follow-up tailored for public sector clinics and          low-income and minority patients.        2. Adapt an evidence-based collaborative care model for primary care, implement the adapted          model, evaluate and further refine the model based on the pilot experience, and produce          and disseminate a detailed manual for use in public sector clinics.        3. Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to          determine: its acceptance by patients, medical providers, and organizational          decision-makers; patient depression treatment adherence; its direct cost; and the size          and variability of change from baseline in the primary outcome measures: depressive          symptoms, functional status, quality of life, health service use, and cardiac status at          6 and 12 month follow-up.   "
92915|NCT02069899|"     International, multicenter, long-term, follow-up study that will enroll HLH patients who have     received NI-0501 in a previous clinical trial, in the context of the clinical development     program for NI-0501   "
92916|NCT02069886|"     The CENTAurus trial is a prospective clinical study designed to address systematically some     of the relevant endocrine complications in an iron overloaded thalassemic population, primary     objective being the assessment of the effect of deferasirox therapy on glucose     metabolism/homeostasis. Other endocrine parameters complementary or supportive to the primary     objective will be assessed and analyzed during this study. A number of lab parameters related     to other axes of the endocrine system will be collected and analyzed.   "
92917|NCT02069873|"     The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of     evidence-based therapies in comparison to a wait-list control and evaluate the relative     contribution of exposure, cognitive, and skills blocks of treatment in a 16-session     manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1:     Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and     Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD     symptoms than the skills component. Significant results will establish the efficacy of a     group format for evidence-based treatments for all veterans with a PTSD diagnosis. An     ancillary part of the study is to examine initial neuropsychological presentation in this     population and possible changes that may occur as the result of treatment.   "
92918|NCT02069860|"     A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear,     connected with a double lumen central venous catheter inserted in the jugular vein, and will     be used in conjunction with an adapter as a permanent vascular access for hemodialysis     treatment.   "
92919|NCT02069847|"     Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and     early esophageal cancers. However, esophagectomy is associated with significant morbidity and     mortality. With the advance of therapeutic endoscopy, there has been a growing interest and     application of endoscopic resection and mucosal ablative techniques for the treatment of     these diseases. Esophageal stricture (ES) formation has become an increasingly recognized     complication of extensive endoscopic mucosal ablation and/or resection. The resultant     symptomatic stricture development can significantly impair a patient's quality of life.     Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid     injection is invasive, costly, and associated with the potential risk of perforation.     Recently, oral corticosteroids have been introduced for the prevention of esophageal     stricture after endoscopic submucosal dissection.      Budesonide is a synthetic steroid with topical anti-inflammatory properties and high     first-pass metabolism; thus, potentially less systemic absorption and side effects.      Hypothesis: Oral budesonide prevents esophageal stricture formation in patients who underwent     radical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for     advanced premalignant esophageal lesions or superficial esophageal cancers.   "
92920|NCT02069834|"     The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine     vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout     24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under     conventional HAART (2 NNRTI + 3rd agent).      The main secondary objectives are the following:        -  % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48        -  % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48        -  % of virological failure defined by two consecutive plasma viral load > 50 copies/mL        -  Profile of genotypic resistance in case of virological failure.      The trial will be conducted according to the design below, in 3 steps:        -  Step 1: enrollment of 80 patients (40 in each arm)        -  Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the          intervention arm have been analyzed.        -  Step 3: resumption and completion of enrollment if conditions for resuming enrollment at          the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the          intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is          significantly > 70%, which translates in a maximum of 6 virologic failures.   "
92921|NCT02069821|"     The purpose of the study is to assess the pharmacokinetic interactions between amlodipine     besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.   "
92922|NCT02069808|"     Disprove the null hypothesis as follows:      Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH     medication per treatment protocol outlined below, use of adjunctive LH activity medication     Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as     from egg donors not treated with Menopur™.      Objectives:      Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity     medication Menopur ™ for our volunteer egg bank donors.      Efficacy defined as:        1. #Days of ovarian stimulation to GnRH agonist trigger.        2. Peak serum estradiol level on day of GnRH agonist trigger.        3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.        4. Number of mature oocytes recovered and cryopreserved.      Study type: Randomized prospective clinical trial.      Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA and     the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle count     of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.      Study design:      Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and     adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval.      Random number generator with patients assigned basd on odd or even numbers.      Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible     cycle cancellation for poor ovarian response or patient elective withdrawal to result in at     least 20 subjects in each group completing the study.      Primary measure of outcome: number of mature oocytes recovered and cryopreserved.      Secondary measures of outcome:        1. #Days of ovarian stimulation to GnRH agonist trigger.        2. Peak serum estradiol level on day of GnRH agonist trigger.        3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.   "
92923|NCT02069795|"     The waveform assessment of an athlete's speech production has a high probability of showing     abnormalities after brain injury (concussions) which could be used not only for diagnosis of     the concussion, but for recovery of the brain. The aim of this study is to investigate this     possibility using the Cobweb automated application system for acoustic processing.   "
92925|NCT02069769|"     The goal of this study is to determine if scheduled communication with the oncology team     through phone calls is helpful to caregivers with the transition to hospice care.   "
92926|NCT02069756|"     DuchenneConnect is an online, patient-report registry for individuals with Duchenne and     Becker muscular dystrophy and carrier females. The purpose of DuchenneConnect is to connect     Duchenne and Becker patients with actively recruiting clinical trials and research studies,     and to educate patients and families about Duchenne and Becker care and research. At the same     time, DuchenneConnect is a valuable resource for clinicians and researchers in academia and     industry, allowing access to a de-identified, aggregate dataset provided by patients and     their families—information that is vital to advances in the care and treatment of Duchenne.     DuchenneConnect is a member of PCORnet, the National Patient-Centered Clinical Research     Network.   "
92927|NCT02069743|"     The investigators have developed a mobile application (for use on smart phones) to help     cancer patients better manage cancer pain. This study is a randomized controlled trial to     evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that     subjects randomized to the intervention group will achieve greater reductions in     cancer-related pain and improved quality of life.   "
92928|NCT02069730|"     This is a study of select drug therapies in patients with salivary gland cancer. The study     has two phases: a molecular profiling phase (phase 1) and a treatment phase (phase 2).      In molecular profiling phase of the study, participants will provide a sample of their tumor     tissue to test for changes in certain genes that show whether certain drug treatments will be     more useful than others.      Once participants have undergone molecular profiling, they will be offered a drug treatment     depending on the results. Certain drug treatments are designed to target certain gene     changes. If there is a matching drug treatment, participants will be offered that treatment     (either outside a clinical trial or within a clinical trial). If there are no gene changes or     there are changes to genes were there are no drug treatments available for those certain     changes, participants will be offered the study drug, Selinexor.      Cancer is the uncontrolled growth of cells. Research shows that one way cancer cells can grow     uncontrollably is when certain proteins, called exporter proteins, are present in high levels     in the body. These proteins prevent certain other proteins important in protecting cells from     becoming cancerous and important in the controlling the growth of cells, from working. The     study drug Selinexor is new class of drug called Selective Inhibitor of Nuclear Export (SINE)     that blocks the exporter proteins from working which may allow the other proteins to work and     slow or stop tumors from growing.   "
92929|NCT02069717|"     The purpose of this study was to assess the incidence rate of the major adverse     cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin     therapy in patients who have history of acute myocardial infarction and are diagnosed with     metabolic syndrome.   "
92930|NCT02069704|"     This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab     biosimilar) and Avastin® with 2 parallel arms to compare the PK profile of BEVZ92 and     Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy.      FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital     standard of care.   "
92941|NCT02069561|"     The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to     colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic     Acid treatment might be associated with changes of the gut microbiota and metabolomic     profiles in patients with long-standing ulcerative colitis.   "
93118|NCT02067260|"     The overall purpose of this clinical investigation is to collect data to support a marketing     application for over the counter use of the X5 HairLaser with an indication for hair growth.     The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can     safely and effectively perform self-use application by following written instructions.   "
92931|NCT02069691|"     Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking and     balancing ability. Many studies point out that cycling is an effective means for lower limb     rehabilitation. However, during training, the unaffected limb may compensate for the affected     one resulting in suboptimal rehabilitation. To address this issue, the investigators     developed the virtual reality-cycling training system (VRCTS) which can acquire force and     speed signals in real-time through a cycling module. The system then analyzes the acquired     data and uses a 3D VR rehabilitation program to help patients to train their affected side.     The aim of the study was to develop the VRCTS, verify its function and test system function     on both normal subjects and stroke patients.      Methods: In this system, the investigators designed a cycling device that is embedded with     load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling Graph     User Interface Control and Data Recode System (Cycling CR System) was applied for signal     analysis and feedback control. The investigators designed a 3D interactive VR rehabilitation     program that can guide and train the users through visual feedback. Each user performed a     pre-test to examine determine condition, left-right balance and other parameters, which     allows the system to be customized.   "
92932|NCT02069678|"     This will be a multi-center study in Hong Kong. This is a retrospective-prospective study in     HBeAg-negative chronic hepatitis B patients. HBeAg-negative patients on entecavir followed up     in the liver clinics will be identified from the existing database. All patients had HBV DNA     testing every 6 months as a clinic routine. Serum HBsAg levels will be tested in the residual     serum samples at the pre-treatment and last follow-up visits. Eligible patients will be     discussed on the plan of stopping entecavir therapy. All patients will have written informed     consent before recruited into this study. All patients will be followed up for 12 months     after stopping entecavir treatment. As entecavir is most commonly used antiviral drug in Hong     Kong and in the Western countries, the investigators aim to investigate and validate the use     of serum HBsAg quantification to guide the timing of stopping entecavir in HBeAg-negative     patients. The results of this study will provide scientific evidence on the use of this new     serum marker to predict sustained remission after stopping entecavir. In the long-run, it can     improve patient compliance, reduce the need of long-term antiviral and reduce the drug cost     in the management of HBeAg-negative chronic hepatitis B.      All patients will stop entecavir according to the Asian Pacific guideline with written     informed consent and close subsequent monitoring. In the protocol, there is a safety net for     re-treatment. There will not be any invasive procedure. There is no major ethical issue.   "
92933|NCT02069665|"     The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine     for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.   "
92934|NCT02069652|"     The data of Taiwan CDC showed the total HIV victims amounted up to 22,020 from 1984 to 2011.     Under risk factor analysis, it indicated the increasing victims among MSM (men having sex     with men, including homosexuals & bisexuals) cohorts, from 64% of them in 2009 to 72% in     2011. For age stratification of patients, the youth (from 15 to 24 years old) comprised of     18.5% (4078). Among them, 40% are students. MSM are still the main population (over 80%) from     2009 to 2011. Therefore it is crucial to target the young MSM.   "
92935|NCT02069639|"     Relapsed and refractory Hodgkin's lymphoma (HL) patients may experience long-term survival     after allogeneic transplant (alloSCT), but disease recurrence represents the main cause of     treatment failure. PET (positron-emission tomography) -positive patients after alloSCT have a     dismal outcome. Serum TARC (thymus and activation-regulated chemokine) is produced by     Reed-Sternberg cells and may be a marker of disease. Our study was aimed at assessing whether     TARC levels after alloSCT were correlated to disease status and whether TARC monitoring could     increase the ability to predict relapse.   "
92936|NCT02069626|"     Bleeding from the staple line is a complication of linear stapling. After clamping, a short     period after firing of the laparoscopic linear stapler is recommended. That is, the clinician     should continue to press the tissue between the prongs of the device to achieve adequate     hemostasis at the staple line. The significance of the waiting period for hemostasis at the     staple line has not been empirically clarified in humans. In this study, the investigators     compared the number of bleeding points use of the laparoscopic linear stapler. Consequently,     the investigators assessed the effects of time after the firing of linear stapling in     patients who underwent laparoscopic gastric bypass.   "
92937|NCT02069613|"     The objective of the study is to determine the relative roles for various testing modalities     in the diagnosis and prognosis of mild traumatic brain injury.   "
92938|NCT02069600|"     Rationale: Almost all the information the investigators have about the effect of continuous     positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) comes from     randomized clinical trials including only middle-aged patients. Little is know, however,     about the effect of CPAP in elderly people with OSA. Objective: To assess the effect of CPAP     treatment in elderly patients with severe OSA on clinical, quality-of-life and neurocognitive     spheres. Methods and Measurements: Open-label, randomized, multicenter clinical trial of     parallel groups with blinded end-point design conducted in 12 Spanish teaching hospitals on a     consecutive clinical cohort of elderly (≥ 70 years) patients with confirmed severe OSA (IAH≥     30) receiving CPAP or no therapy while maintaining their usual control for three months. CPAP     titration was performed by an auto CPAP device. A good adherence was set as at least 4     hours/day of CPAP use. Primary endpoint was the measurement of quality of life by the Quebec     Sleep questionnaire, which includes diurnal and nocturnal symptoms, hypersomnolence, and     social and emotional dimensions. Secondary endpoints include different sleep-related     symptoms, presence of anxiety or depression, office blood pressure figures and some     neurocognitive tests. Patients were invited to a clinical visit on three occasions to     quantify the adherence to CPAP. Intention-to-treat analysis was performed.   "
92939|NCT02069587|"     Preterm premature rupture of membrane is associated with increased oxidative stress and     inflammatory process, enhancing the activity or the availability of antioxidants may modulate     the inflammatory response associated with PPROM, thereby reducing oxidative stress and the     risk to the fetus. In this study the investigators sought to determine the effects of     Pomegranate 1. On the patients (maternal and fetal) oxidative stress and inflammation     associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients     (fetal )Ph and apger scores   "
92942|NCT02069548|"     This study addresses postures and range of motion in cervical dystonia (Spasmodic     Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase     the understanding of the biomechanics of the movement disorders of the cervical column in     this pathology. In addition, the clinical state of cervical dystonia of the patients will be     assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The     investigators will compare the results between control and study groups.   "
92943|NCT02069535|"     This trial is an open, national, multi-centre trial. The main objective of this trial is to     assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement     of related Adverse Events.   "
92944|NCT02069522|"     This is a prospective, double blind, crossover study in healthy infants randomized to one of     two study formulas. The trial will consist of two 21 day study feeding periods separated by a     study washout period.   "
92973|NCT02069145|"     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and     PK of OMP-54F28 when combined with sorafenib. OMP-54F28 will be administered IV on Day 1 of     each 21-day cycle. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg. Depending on     safety in this study, additional lower or intermediate dose levels may be evaluated.   "
92948|NCT02069470|"     Background Denmark has a lower survival of cancer compared to most European countries. Fast     track pathways for organ specific cancers were established in the years 2008-2010. In 2011     further a fast track pathway for non-specific serious symptoms. Cancer in general practice is     a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients     per year. The investigators know that cancer patients have an increased use of general     practice prior to diagnosis and that 25% of them wait for more than 20 days in general     practice for referral according to the GPs. The latest Danish Cancer Plan therefore includes     a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track     pathways.      The aim of this study was to investigate the effect of this CME in early cancer diagnosis.     This is measured by changes in GP knowledge, attitude and risk assessment. GP referral     behavior assessed by primary care interval and use of fast track referrals. GP´s cancer hit     rate, cancer patients´ tumor stage at treatment and 1 year survival.      Methods/Design The study is conducted as a stepped wedge controlled design based on a     quasi-cluster randomization.      In august 2012 an invitation to participate in the present study were sent to 859 general     Practitioners (GPs) from the Central Denmark Region. GPs completed a form for each patient     they referred to a fast-track diagnostic pathway for cancer within an 8-month period.      Every other week, we received data from a regional database. We reminded the referring     GP-practice about non included patients. The collected data will be linked to registries.      The CME-intervention The CME-course was a 3-hour meeting after work. Guided by the available     evidence from the literature following the investigators ensured a multifaceted interactive     teaching method including case-based education. The content included by other topics positive     predictive values, false reassurance from negative testing and other pit-false.      Statistical analyses The outcomes will be analyzed in a generalized linear random-effects     model with random effect of GPs. Based on data it will be assessed whether further modeling     of inter correlation within practices and within clusters is required, and whether the     intervention effects are assumed equal for all GPs, or in random interaction with them.     Analyses will be performed both in the full GP-population (intention to intervening ) and     in the 3 subgroups of GPs.   "
92949|NCT02069457|"     Several studies have confirmed that patients with cirrhosis possess an imbalance in     procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein     C. Moreover, in the last two decades there has been an increased recognition that not only     bleeding but also thrombosis complicates the clinical course of cirrhosis. The prevalence and     pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis without     hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess the     prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular     carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these     patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The     patients are going to follow up for one year and evaluate at baseline and every 6 months by     liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical     events will be evaluated at every follow up.   "
92950|NCT02069444|"     For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On     the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having     a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes.     The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope     in terms of intubation difficulty score, time to intubation and intubation quality score.   "
92951|NCT02069431|"     The life expectancy of older Americans continues to increase, with persons aged > 65 years     representing the fastest growing segment of the US population (Manton et al., 1995). While     prolongation of life remains an important public health goal, a goal of even greater     significance is that extended life should involve preservation of the capacity to live     independently and to function well physically, cognitively, and socioemotionally (Katz et     al., 1983). Therefore, identification of proven interventions to maintaining functioning     across these domains and prevent disability is a major public health challenge (Branch et     al., 1991). Greater physical and cognitive independence in older adults has been shown to     crucially influence social integration in old age (Cornwell & Waite, 2009), resulting in     significant increase in quality of life and reduction of risk for morbidity and mortality,     social stress, anxiety, and depressive symptoms (Bassuk et al., 1999; Seeman, 1996). A     promising candidate to promote functional levels across physical, cognitive, and     socioemotional domains is the neuropeptide oxytocin (OT) (Barraza et al., 2013; Bartz et al.,     2011; Feifel et al., 2012; Meyer-Lindenberg et al., 2011; Szeto et al., 2012). Combining     neuroendocrine with behavioral approaches (e.g., performance-based measures of physical and     cognitive function), the proposed multidisciplinary research therefore sets out to clarify     the extent to which intranasal administration of OT over a period of 4 weeks can reduce     inflammation and improve physical and cognitive function in older men. Constituting a     complementary piece to the IRB approved currently ongoing Faces Study (IRB # 39-2013), this     project will also allow examination of interactions between OT's effect on physical health,     cognition, and socioemotional function.   "
92952|NCT02069418|"     In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances     have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine     kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as     erlotinib.      This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST     criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.      Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and     18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has     identified early responding patients and with better progression-free survival in erlotinib     first line and in the second or third line.      To date, none medico-economic study has been conducted to determine if this strategy will be     cost-effective.      The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and     18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib     (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to     the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of     erlotinib treatment.      A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements,     in particular targeted therapies in NSCLC, have improved quality of life and life expectancy,     but have also induce an important increase of the health costs. According to studies, the     mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last     years. More efficient strategies that would permit to stop early with objective endpoints,     expensive therapies is a main achievement in thoracic oncology.      The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders     and replace another treatment before a deterioration in their physical status, 2) reduce the     risk of side effects and costs of unnecessary treatment and 3) to propose a customization     treatment after the first line therapy.   "
92953|NCT02069405|"     To acquire low radiation dose and good quality cardiac CT images requires scanning at low     heart rates which is usually done with beta-blockers. However, in some patients beta-blockers     have little effect. This is thought to be due to a different mechanism of action which     continues to maintain the heart rate despite administration of beta-blockers. This study aims     to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety     is thought to play a role in maintaining high heart rates. This study will randomise patients     into a normal standard of care group compared to a normal standard of care group with music/     relaxation track and compare heart rate, radiation dose, image quality, amount of     beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI)     questionnaire.   "
92954|NCT02069392|"     Schizophrenia is marked by problems in attention, memory and problem solving. These deficits     predict long-term functional outcome such as the ability to live independently and maintain     employment, but they are not ameliorated by currently available medications. Cognitive     training improves these functions to some degree, but this approach is time- and     resource-intensive. The current project aims at enhancing and accelerating the benefits that     people with schizophrenia derive from cognitive training by administering nicotine during     some of the training sessions. This would provide the proof of principle for a type of     treatment intervention to improve cognitive symptoms of schizophrenia.      The current project aims at determining whether the intermittent presence of nicotine during     cognitive training exercises in people with schizophrenia will shorten the training period     necessary to induce significant and clinically relevant improvement and enhance the     improvement seen after a training period of specified length.      Hypothesis 1a: Nicotine administration during training will increase the size of all measured     effects of the training intervention, and will accelerate the time course of performance     enhancement on the MCCB and training exercise progression parameters.      Hypothesis 1b: The larger training effects in the Nicotine Group will persist beyond the end     of the intervention.      Hypothesis 2a: Within-session progress on the training exercises will be larger in the     presence of nicotine than in the presence of placebo.      Hypothesis 2b: These acute nicotine-induced performance elevations will persist beyond the     presence of nicotine through subsequent non-drug training sessions, giving evidence of an     acute facilitation of learning processes.   "
92955|NCT02069379|"     Insulin resistance, a primary component of the metabolic syndrome, is an escalating     phenomenon in the United States, and confers an increased risk of depression and mood     disorder, particularly in women. The relationship between metabolic and mood disorders may be     mediated by endogenous opioid activity in limbic brain regions. We propose to examine     affective state and μ- opioid system function in insulin resistant women, and change in     response to insulin sensitizing treatment, through the following specific aims and     hypotheses:      Establish relationship between insulin resistance, affective state, and μ-opioid receptor     function.        1. Insulin resistant women will have greater μ-opioid receptor availability at baseline,          and a larger response to stress challenge than non-insulin resistant women        2. Insulin resistant women will have greater negative affective state at baseline, and a          greater emotional response to stress challenge than non-insulin resistant women.        3. Mediational analyses will reveal that the relationship between insulin resistance and          negative affect is mediated by μ-opioid receptor function and neural activation in the          amygdala and nucleus accumbens affect-regulating regions.      Examine effects of insulin regulation on μ-opioid receptor function and affective state.        1. Improved insulin sensitivity will be accompanied by decreased μ-opioid receptor          availability at baseline and a reduced response to stress challenge. Degree of change in          baseline receptor availability and response to stress challenge after treatment will          correlate with degree of insulin regulation.        2. Improved insulin sensitivity will be associated with improved affective state at          baseline, and with a reduced emotional response to stress challenge. Degree of change in          affective state and emotional response to stress challenge after treatment will          correlate with degree of insulin regulation.        3. Mediational analyses will reveal that the change in affective state after insulin          regulation is mediated by change in μ-opioid receptor function and neural activation in          the amygdala and nucleus accumbens.      The expected results would suggest a role for the endogenous μ-opioid system in mediating the     relationship between metabolic function and emotional processes.   "
92956|NCT02069366|"     The goal of this study is to look at how a type of drug called cannabinoids are related to     the processing of fear signals, the experience of emotions and fear, and the pattern of     activity in the brain that is involved in these processes and how this relates to the     development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs     after experiencing a traumatic event(s) and is characterized by unwanted memories of the     trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of     the event, difficulty experiencing emotions, loss of interest in activities the person used     to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger     and hypervigilance. The information gained from this study could lead to the development of     new treatments for persons who suffer from anxiety or fear-based disorders.   "
92957|NCT02069353|"     Cardiac arrest is the most common cause of death in the United States and as many as 590,000     Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to     89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury     is the most common cause of death and disability after cardiac arrest. The investigators use     advanced brain monitoring in patients who are at high risk of death after cardiac arrest,     with the goal of preventing ongoing brain injury. The most common problem the investigators     have observed is low oxygen levels in the brain, which is often very difficult to treat.      In this study, the investigators plan to use two additional brain monitors in the care of     these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in     the brain. The investigators will use these to detect and treat potential causes of low brain     oxygen levels. The main hypotheses are that electrical events in the brain such as seizures     and spreading depolarizations will occur during times of low brain tissue oxygen level, and     that treating these events and low blood flow will reduce the rate of low brain oxygen     levels.   "
92958|NCT02069340|"     This randomized clinical trial studies genetics in predicting risk of bisphosphonate-related     osteonecrosis of the jaw in patients with cancer receiving zoledronic acid. Zoledronic acid     is an anti-resorptive drug used as part of cancer treatment. A serious side effect of these     drugs is death of the jawbone, commonly called bisphosphonate-related osteonecrosis of the     jaw (BRONJ). Genetic research may help doctors understand risk factors for BRONJ or who is     more likely to get BRONJ and why.   "
92959|NCT02069327|"     This is an observational study designed to investigate the role of fat emboli in patients who     are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of     this study is to obtain samples of bone marrow and blood during tibial or femoral fracture     procedures to understand the inflammatory response.   "
92960|NCT02069314|"     This research study was conducted to investigate the effects of a high protein diet on the     efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was     that a high intake of dietary protein would result in a less efficient use of energy in     skeletal muscle in older adults.   "
92961|NCT02069301|"     The study evaluates LIFE-DM, an integrated microfinance and collaborative care intervention     by comparing it to enhanced treatment as usual (national guideline antidepressant care and     referral to microfinance resources) in Vietnam. Intervention effects at baseline, 6 month,     and 12 month follow-up on patient outcomes, including depression, anxiety, quality of life,     functioning, self-efficacy, satisfaction, and income will be compared across the two     conditions.   "
92962|NCT02069288|"     Septic shock (associated with relative adrenal insufficiency) is characterized by decreased     arterial responsiveness to catecholamines. The association of hydrocortisone and     fludrocortisone has demonstrated an improvement in survival in septic shock patients. If     hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone     remains to be elucidated. The purpose of our study is to investigate the effect of a     physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure     dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with     septic shock.   "
92964|NCT02069262|"     There were many approaches for patients with obscure gastrointestinal bleeding (OGIB).     Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy,     laparoscopy, computed tomography and angiography have been recommended as investigation.     However, of these techniques, the evaluation and management of patients with OGIB remains a     formidable challenge. We compared the diagnostic yield and long-term outcomes of patients     with OGIB randomized to angiogram combination laparoscopy or angiogram alone.   "
92965|NCT02069249|"     The proposed study has the following aims: (a) to assess the concomitant and longitudinal     links between sleep and cognitive, behavioral and emotional functioning in kindergarten     children; (b) to assess the immediate and the long-term effects of an intervention to promote     healthy sleep habits (HSI) on the child's evolving sleep patterns, as well as on related     cognitive, behavioral and health domains; (c) to assess the immediate and the long-term     effects of an intervention deigned to promote healthy nutrition (HNI) on the eating habits of     children, their weight and BMI measures (the comparison/control group) and (d) to assess the     links between eating habits and sleep in kindergarten children.      The main hypotheses of the proposed study are: (a) Shorter and more disrupted sleep would be     concomitantly and longitudinally associated with compromised cognitive, emotional and     behavioral functioning in kindergarten children; (b) In comparison to the HNI group, children     in the HSI group will extend their total sleep time, improve their sleep quality and their     sleep schedule will be more stable following the intervention; (c) improvement in sleep     habits will be associated with improvement in cognitive, emotional and behavioral     functioning; (d) in comparison to the HIS group, children in the HNI group will improve their     eating habits, engage in more physical activities and better manage to achieve and maintain     an age-appropriate body weight.   "
92966|NCT02069236|"     In this study we propose to determine the correlation in glucose-6phosphate dehydrogenase     enzyme activity in capillary blood obtained from a finger stick versus a venous blood     specimen. As secondary endpoints we will seek to correlate phenotype as determined by     quantitative and qualitative G6PD test, genotype as determined by PCR and DNA sequencing with     flow cytometry. The secondary endpoints are critical for the design of G6PD diagnostic test     evaluation studies.   "
92967|NCT02069223|"     Bariatric surgery procedures promote weight loss by limiting the amount of food consumed     through reduction of the size of the stomach and by decreasing absorption of nutrients     through reorganizing or bypassing portions of the small intestine. Among the procedures used     to induce weight loss, sleeve gastrectomy (SG) was initially developed in the early 90's as     the restrictive component of a biliopancreatic diversion with duodenal switch (BPD-DS). It     was then offered by laparoscopy as a staged-approach in order to reduce peri-operative     complications in high-risk patients. The second step of the surgery (i.e. the duodenal     switch) was planned when sufficient weight loss had been obtained. However, it was observed     that some patients experienced appreciable weight loss with the SG alone, and did not require     a second-stage surgery, thus avoiding the side-effects of a malabsorptive surgery. This led     to the surge in popularity of SG as a stand-alone operation, because of its relative     technical simplicity, feasibility, and good outcomes. Multiple mechanisms have been     postulated to induce metabolic recovery and weight loss following surgery. The independent     effects of each component of the BPD-DS with SG have never been investigated in humans within     a well-controlled study design. The general objective of the present project is to assess the     impact of each component of the BPD-DS and SG, either combined of separated, on physiological     variables potentially responsible for metabolic recovery. Patients will be randomized to     undergo one of three surgical sequences: 1) SG followed by BPD-DS one year later; 2) BPD-DS     followed by SG one year later; or 3) SG and BPD-DS within a single operation. A series of     tests will be performed at baseline, at 1 year, and 2 years after the initial surgery. We     propose two Specific Aims to asses 1) the impact of each surgical component on the hormonal     determinants of metabolic recovery; and 2) the impact of weight loss responses on     subcutaneous and visceral adipose tissue function improvements. This project will help better     understand the mechanisms underlying metabolic recovery following weight loss surgery.   "
92968|NCT02069210|"     The purpose of this study is to investigate the effect of transfusion of allogeneic     (homologous) red cells on the immunologic parameters such as T-cells as well as natural     killer cell count/function, various interleukins, TNF alpha and other immunologic relevant     parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.   "
92969|NCT02069197|"     The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD)     treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea     (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This     will be a randomized, open-label three arm controlled study comparing weight loss in obese     participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with     3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet (Group A) with weight loss in     participants treated with orlistat 120 mg TID and lifestyle intervention consisting of     dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants     treated with only lifestyle intervention consisting of dietary advice, recommended caloric     goal of 1600 kcal/day (Group C).   "
92970|NCT02069184|"     Post-operative pain management after C-section is an important topic as the number of     elective c-sections increases each year. Pain is managed either by giving opioids or by using     non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen     in pain relief and its impact in the usage of post-operative opioid requirements and opioid     associated complications. The hypothesis is that four doses of IV Acetaminophen in     conjunction with intrathecal or epidural morphine given to the patients after c-section will     reduce post-operative opioid requirements and opioid associated complications.   "
92971|NCT02069171|"     The purpose of this study is to identify the incidence,feature,clinical significance for leg     lymphedema after gynecologic cancer treatment.   "
92972|NCT02069158|"     This is a phase Ib single arm, open-label, multiple dose, dose escalating, safety,     pharmacokinetic and pharmacodynamic study of the combination of PF-05212384 with paclitaxel     and carboplatin. The study will be conducted in adult patients with advanced breast, NSCLC,     ovarian or endometrial, small cell lung cancer (SCLC) and Head and Neck (HNSCC) cancer for     whom there is an indication to the use of paclitaxel and carboplatin.      Successive cohorts of patients will receive escalating doses of PF-05212384 in combination     with paclitaxel and carboplatin, starting at a dose level determined to be the 60% of single     agent MTD.      The study will consist of two parts: the dose finding part (Part 1) and the expansion part     (Part 2).      During Part 1 patients with breast, NSCLC, ovary and endometrial, small cell lung cancer     (SCLC) and Head and Neck (HNSCC) cancer will be enrolled.      During Part 2, only patients with ovarian cancer will be enrolled. In Part 1, a 3+3 design is     employed. Once the MTD of the combination is defined in Part 1, Part 2 is performed for a     better definition of the safety profile, of the potential antitumor activity and of the     pharmacodynamic effects of the combination; it will be conducted in at least 12 patients with     ovarian cancer.      Approximately 40 patients are expected to be enrolled in the study overall.   "
92980|NCT02069054|"     Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases.     Although the clinical features of asthma and COPD may be similar, the pathogenesis of these     diseases differs in many aspects.      The aim of this study is:        -  to evaluate airway inflammation in asthma and COPD,        -  to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,        -  to assess the relationship between markers of airway inflammation and airway remodeling          in asthma and COPD patients.      Material and methods:        -  mild to moderate asthma patients diagnosed in accordance with Global Initiative for          Asthma (GINA) guidelines,        -  mild to moderate COPD patients diagnosed in accordance with Global initiative for          chronic Obstructive Lung Disease (GOLD) guidelines,        -  healthy subjects as controls.      Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC),     bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway     wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial     ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.      We plan to compare airway inflammation and features of airway remodeling in asthma and COPD     patients.   "
92981|NCT02069041|"     The main purpose of this study is to determine if the advised dose of ramucirumab is safe to     be taken with chemotherapy treatment in participants with advanced liver tumors.   "
92982|NCT02069028|"     This is a systematic review and Meta-Analysis of interventions for implementation of     Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction   "
92983|NCT02069015|"     The primary aim of the study is to determine if enhanced discharge from the emergency     department will improve blood pressure control and self-care management. Enhanced discharge     will include a hypertension intervention delivered by a touch-screen kiosk over a three month     period.   "
92984|NCT02069002|"     The aim of the current study is to compare the effictiveness of three different psychosocial     therapies for treating functional disorders caused by indoor air problems.   "
92985|NCT02068989|"     We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2     diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose     readings reviewed during their intensive care unit stay. All subjects are consented and have     a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then     followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes     mellitus over the course.   "
92986|NCT02068976|"     This is an observational epidemiologic multicentric study of follow-up a cohort for described     the situation of patients with primary ovarian insufficiency in public population with     respect to the age of apparition the primary ovarian insufficiency .   "
92987|NCT02068963|"     This non-interventional clinical study will be conducted to prospectively collect serial     plasma and serum samples from treatment naïve subjects with chronic HCV infection who are     initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility     endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of     HCV-infected patients undergoing HCV antiviral therapy.   "
92988|NCT02068950|"     The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance     training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared     to usual care.   "
92989|NCT02068937|"     One of the challenges in treating patients with heart failure (HF) is achieving clinical     stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm     developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for     use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily     applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to     describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD     and of nonpharmacologic management in improving clinical stability and reducing the     readmission rate at 90 days in patients with HF.   "
92990|NCT02068924|"     Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows     single embryo transfer to be applied without compromising pregnancy rates after the first in     vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less     than 36 years old with good embryo quality. The policy of transferring more than one embryo     after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies     reported in Europe and United States over the past 15 years. These multiple pregnancies are     the main disadvantage of ART because of their negative impact on obstetrical, neonatal and     economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of     development at the cleavage stage. With the development of physiologically-based sequential     culture media, it has also been suggested that extending embryo culture to Day-5 in order to     transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy.     Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh     blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.      However a recent embryo freezing technique (vitrification) seems to show significant higher     pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications     have reported the outcome of single embryo transfer at blastocyst stage by a prospective     randomized and comparative study including the results of fresh and frozen/thawed blastocyst     by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .      Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos     to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization     program with Single Embryo Transfer policy in a prospective and randomized study integrating     the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification     procedure.   "
92991|NCT02068911|"     The purpose of this study is to compare the measure of the CO2 obtained on the end-tidal     expiratory gas (ETCO2) with the value of CO2 obtained by transcutaneous measure (PTCO2), in     home-ventilated neuromuscular patients.   "
92992|NCT02068898|"     The study will assess bioavailability of XS003 given as a single oral dose compared to     Tasigna® given as a single oral dose in healthy male subjects.   "
92993|NCT02068885|"     This study will evaluate the effects of dietary composition on energy expenditure and chronic     disease risk factors, while also exploring physiological mechanisms underlying these effects.   "
92994|NCT02068872|"     The rapid rise in obesity (body mass index (BMI) ≥ 30 kg/m2) in the US over the past decade     is responsible for more disease and death than any other single factor. Severe obesity is     associated with numerous co-morbidities contributing to increased mortality risk, including     end stage liver disease. Liver transplantation is a life-saving procedure for patients with     end stage liver disease and obesity is becoming increasingly prevalent in this population. In     one study, 54% of patients undergoing orthotopic liver transplant (OLT) were either     overweight or obese [body mass index (BMI) >25 kg/m2], and 7% were severely or morbidly obese     (BMI > 35 kg/m2). In addition, weight gain after solid organ transplantation is common     because of steroid-containing immunosuppression and physical inactivity from decreased     exercise tolerance.      Obesity has been shown to increase the surgical morbidity, including wound infections, wound     dehiscence, and hernias after transplantation. More significantly, excess pretransplant body     weight hinders the rate of improvement in health-related quality of life after liver     transplantation[7].      One possible approach for treating obesity after a liver transplant is to use bariatric     surgery. Currently, bariatric surgery is established as the most effective means for both     weight loss and resolution of metabolic disease in the morbidly obese. Recent publications     emphasize the usefulness of bariatric surgery in the reduction of long-term cardiometabolic     risk, cardiovascular disease incidence and mortality, and the management of uncontrolled type     2 diabetes (T2DM). In addition, it decreases mortality and improves both social functioning     and quality of life.      Bariatric surgery may improve eligibility for transplant in patients previously excluded due     to excessive weight. Bariatric procedures, such as sleeve gastrectomy, allow for significant     weight loss over time that greatly reduces or eliminates obesity related illnesses such as     diabetes, high blood pressure and liver disease.      According to the National Institutes of Health, bariatric surgery is reserved for patients     with a BMI of > 40 or > 35 kg/m2 in the presence of major co-morbidities (e.g. type 2     diabetes, hypertension, sleep apnea, heart disease, etc).      A significant number of liver transplant candidates have obesity-related illnesses, thus     putting them at risk for cardiovascular and metabolic complications post-transplant. In     addition, patients awaiting OLT are typically no longer medically stable to undergo intensive     diet and exercise regimens as treatment for their diseases. Finally, decreased activity and     medications used to prevent liver graft rejection all contribute to increased weight gain     following transplant. In fact, in a series of 320 non-obese liver transplant recipients,     21.6% of patients became obese within two years of transplant. These comorbidities also     contribute to poorer post-transplant outcomes and development of what is known as the     post-transplant metabolic syndrome. Morbidly obese patients (BMI > 40 kg/m2) may also have     higher frequencies of morbidities such as prolonged hospitalization and readmission as well     as infectious, wound, and cardiovascular complications after transplantation. Finally,     intra-abdominal adiposity creates a technically more challenging operative dissection, but no     data exist on whether it increases perioperative morbidity or mortality in liver transplant     patients.      Sleeve gastrectomy is the most attractive restrictive procedure in a liver transplant     population for several key reasons. One, sleeve gastrectomy does not require the implantation     of a foreign body, such as placement of an adjustable gastric band, which in an     immunocompromised post-transplant patient raises concern for severe infectious complications.     Secondly, as stated previously, sleeve gastrectomy is a purely restrictive procedure, and     therefore is least likely to cause significant macronutrient and micronutrient deficiencies.     Finally, when compared to other restrictive procedures, such as adjustable gastric band     placement, it has a lower likelihood of treatment failure (i.e. <50% excess weight loss). In     fact, recent reports describe not only high failure rates with adjustable gastric band     placement, but also high reintervention rates for both band-related complications (e.g. band     erosion, leakage, slippage, port infection and esophageal dilatation) and failure to lose     weight such that as few as 54% of patients may have their band in place after 10 years.   "
93009|NCT02068677|"     1. To evaluate the efficacy of EUS-CPN in subjects who experience a sympathetic response     during injection when compared with subjects who do not experience sympathetic response     during injection.      EUS-CPN when performed in subjects who experience a sympathetic response during injection     will have better pain relief when compared to subjects who do not experience a sympathetic     response during injection.   "
93010|NCT02068664|"     The purpose of this study is to determine if stroke survivors with aphasia have spatial     neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered:     which is prism adaptation treatment. This is a pilot study that will be performed with 4-5     subjects.   "
92995|NCT02068859|"     Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint     pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly     effective, it causes substantial side effects including gastritis and gastric ulcer disease,     renal impairment, hypertension, and thrombotic events. These types of oral medications are     utilized by millions of Americans on a fairly regular basis in both over-the-counter     preparations and prescription compounds. In recent years, topical preparations of NSAIDs have     been used for localized pain as an alternate to oral administration with reported good     analgesic efficacy. For example, they are often used for knee pain. There is little systemic     absorption of NSAIDs with topical administration, and consequently less likelihood of     systemic side effects.      Though much less studied than oral NSAIDs, topical NSAID preparations are currently     prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied     commercially available products are diclofenac 1% compounds. Higher concentrations presumably     provide higher tissue concentration leading to better and longer pain relief, along with a     more prominent anti-inflammatory effect.      The investigators will therefore compare the efficacy of available topical diclofenac 1% gel     to that of diclofenac 8% cream. Specifically, the investigators propose to test the     hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any     increase in systemic toxicity.      One hundred six patients presenting to the Cleveland Clinic Pain Management Department for     the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or     diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee     over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and     functional/disability status.   "
92996|NCT02068846|"     The purpose of this study is to analyze BK viral infection in salivary gland diseases;     specifically, to determine a definitive relationship between BK Virus and HIV associated     salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1     to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary     function/protein secretion will be correlated with BK polyomavirus titers. We expect that     patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit     from Ciprofloxacin.   "
93015|NCT02068599|"     The primary purpose of the study is to evaluate the change from baseline after 4 weeks of     topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief     of symptoms of primary OA affecting a single knee   "
93016|NCT02068586|"     This randomized phase II trial studies how well sunitinib malate or valproic acid works in     preventing high-risk uveal (eye) melanoma from spreading to other parts of the body.     Sunitinib malate may stop the transmission of growth signals into tumor cells and prevents     these cells from growing. Valproic acid may change the expression of some genes in uveal     melanoma and suppress tumor growth.   "
93119|NCT02067247|"     The purpose of this study is to compare the accuracy and comparability and secondarily to     assess the values achieved by measurement of the forearm BMD by DXA and SOS by BeamMed,     relative to standard DXA evaluations at the FN and LS.   "
92997|NCT02068833|"     Favorable effects of bariatric surgery have been demonstrated in particular regarding     increased insulin sensitivity, decreased blood pressure, improved blood lipids and decreased     cardiovascular risk. After surgery, weight loss also leads to improvement of the chronic     inflammatory state related to obesity, a strong predictor of the metabolic status. Although     obese patients are often affected with type 2 diabetes and hypertension, both related to     renal impairment, the existence of a distinct mechanism by which obesity would cause chronic     renal insufficiency has been suggested. The mechanisms underlying obesity-related nephropathy     have been proposed to involve hyperfiltration, expansion of mesangial cells, hyperperfusion     leading to proteinuria and glomerulosclerosis, as noted in obese dogs. In humans,     improvements in renal function may be observed following bariatric surgery, although some     reported a possibility of increased nephrolithiases. Whether biliopancreatic diversion and     gastrectomy alone have similar effects is uncertain. More prospective studies are needed to     assess the impact of all types of weight loss surgery to reverse chronic renal insufficiency.      The objective of this study is to document changes in microalbuminuria and metabolic     parameters in patients with altered renal function undergoing bariatric surgery. Patients     enrolled in the study will show renal function impairment as demonstrated by     albumin/creatinine ratio alterations in 2 out of 3 measurements taking place before surgery.     We will perform a prospective study of renal function markers (albumin/creatinine ratio) and     metabolic parameters (blood lipids, glucose, insulin, inflammatory markers) before and 6, 12,     24 months after surgery in patients with microalbuminuria at study onset (albumin/creatinine     ratio 2.0-20.0 mg/mmol in men and 2.8-28.0 mg/mmol in women). Data will be analysed with     repeated measures analyses in both subgroup. Thereafter, a linear regression model will be     created to adjust for potentially confounding factors such as hypertension and diabetes. We     hypothesize that patients with severe obesity and altered renal function, whether they are     diabetic or not, have improved microalbuminuria and metabolic parameters following     biliopancreatic diversion with sleeve gastrectomy or sleeve gastrectomy alone. The extent of     renal function recovery will correlate directly with metabolic improvements.   "
92998|NCT02068820|"     The investigators hypothesis is that if sensitivity and specificity are found to be     significantly higher than the current reports with Technesium-99 and ISB colorimetric dye,     SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby     limiting peri-operative morbidity. SLN biopsies might also improve the detection of     metastatic disease, essentially lowering the recognized false-negative rate of standard     lymphadenectomy analyzed by routine H&E pathologic analysis.   "
92999|NCT02068807|"     The balance of the redox state is important for normal embryonic and fetal development .     During the perinatal period, a variety of conditions are responsible for an excessive     production of free radicals. The following oxidative stress is exacerbated by a lack of     antioxidant substances that have not yet matured. At the moment there are no therapeutic     strategies with single or combined antioxidants that have been shown to be clinically     effective.      Breastfeeding is important for the contribution of the antioxidant defenses of the newborn     and the nutritional status of the mother plays a key role because it influences the     nutritional status of the newborn. Lutein is a carotenoid that is not produced by the body ,     but taken with food or supplements. The molecule carries out different activities :     antioxidant, anti-inflammatory, anticancer , neuroprotective. Its main activity of inhibition     of peroxidation of membrane lipids is peculiarly important for the photoreceptors and neurons     whose membranes are rich with polyunsaturated fatty acids. Current evidence on its role as an     antioxidant indicate that supplementation with lutein may play a significant role in the     prevention of free radical disease in the newborn   "
93000|NCT02068794|"     This phase I/II trial studies the side effects and best dose of oncolytic measles virus     encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to     see how well it works in treating patients with ovarian cancer that has come back.     Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian     cancer cells.   "
93011|NCT02068651|"     Advance care planning has been recommended as an integral part of care for patients with     life-limiting disease, but relevant development in Hong Kong is still in its infancy. This     proposed study attempts to address this service gap by promoting advance care planning to     patients with advanced disease. It is hypothesized that the proportion of patients whose     end-of-life care preferences were known in the experimental group will be significantly     higher than that in the control group.   "
97101|NCT02015221|"     The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual     action pneumatic compression device in patients with unilateral or bilateral chronic venous     insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.   "
93001|NCT02068781|"     Currently, the incidence of obesity and obesity-related disorders is reaching epidemic     proportions, which entails an increasing burden for health care systems. The association of     obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such     as insulin resistance and hypertension, is often referred to as the metabolic syndrome.     During recent years, salt-sensitivity of blood pressure has emerged as an additional     cardiovascular risk factor that is related to obesity and other key components of the     metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships     are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a     link between insulin resistance and hypertension in obese individuals. In addition,     impairment of microvascular function was found to be associated with salt-sensitivity of     blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a     cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance.     Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but     was also found to impair endothelial function and thus lower NO-availability, which is     characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are     associated with both hypertension and insulin resistance, which is illustrated in patients     with primary aldosteronism, but also in the general population.      The investigators hypothesize that increased aldosterone levels in obese individuals lead to     impairment of microvascular function through reduction of NO-availability. This microvascular     dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive     hypertension and insulin resistance.   "
93002|NCT02068768|"     The purpose of this prospective clinical study is to examine the short-term safety and     efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat     one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.   "
93003|NCT02068755|"     Blood transfusion is a common procedure essential for the treatment of patients undergoing     cardiac surgery. Inappropriate transfusions, however, not only incur needless healthcare     costs, but increase unnecessary risks due to transfusion reactions and infectious and     immunomodulative causes. Safe and appropriate patient care requires evaluated blood component     prescription practices.      Practically all patients undergoing cardiac surgery in Finland have a blood product booking     from the Finnish Red Cross Blood Service. This registry contains large volumes of     transfusion-related information on all Finnish patients undergoing cardiac surgery in Finnish     centers. Participating hospitals were scattered to all geographical areas in Finland and     concentrated to the most populated regions.      Data on the blood product use, laboratory findings one month pre-operatively and 12 months     post-operatively were available.      Finnish hospitals have been required to provide information on hospital visits for the     Finnish National Research and Development Centre for Welfare and Health for healthcare     planning purposes. We used in part the original data sent by hospitals to the Finnish     Hospital Discharge Register (FHDR).   "
93080|NCT02067754|"     The investigators planned this study to Patients with histologically confirmed metastatic     gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer     therapy : Extra blood sample collection during routine blood sampling.   "
93004|NCT02068742|"     Interventional Study of Early Postoperative Cognitive Dysfunction in Elderly Patients     Undergoing General Anesthesia      The main purpose of this study is to determine the incidence of early postoperative cognitive     dysfunction in elderly patients and its time course.      This study will first evaluate the preoperative cognitive function of elderly patients based     on several criteria including complete patient history, laboratory and instrumental exams,     and the following measures in order to identify conditions and pathologies that may influence     cognitive function.        -  Mini Mental State Examination        -  Geriatric Index of Comorbidity        -  Geriatric Depression Scale      The following neuropsychological tests will be performed on the same day within 7 days of     surgery (baseline):        -  Trail Making Test B-A        -  Digit Span        -  Digit Symbol Substitution Test      The three cognitive function assessments will be repeated at the following postoperative time     points and the change from the preoperative baseline to each time will be evaluated:        -  Day 2 (time point 1)        -  Day 4 (time point 2)        -  Between days 85 and 90 (time point 3)      If the patient seems confused before the postoperative administration of these tests, the     Neecham Confusion Scale will be used to evaluate the patient for the presence of     postoperative delirium; if delirium is not detected, the cognitive function tests will be     administered.   "
93005|NCT02068729|"     An evaluation of the incidence of complications resulting from far lateral spine surgery     utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody     Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the     treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.   "
93006|NCT02068716|"     Our Aim is to identify patient risk factors and clinical practices associated with     healthcare-acquired infections (HAIs) after cardiac surgery.      We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of     Thoracic & Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that elevate     a patient's risk of developing HAIs. The results of this analysis will form the foundation     for the development of standardized regional practices to reduce HAIs. We will explore the     effect of traditional patient-level measures (age, sex, comorbid conditions), process     measures (timing and selection of antibiotics, continuous insulin infusion, transfusions),     and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein     harvesting approach).   "
93007|NCT02068703|"     To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise     machine) in hospitalized patients can positively affect subjective symptoms of sleep quality,     fatigue and pain.   "
93008|NCT02068690|"     To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single     rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI     425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral     drinking solution fasted compared to BI 425809 tablet fasted and tablet fed   "
93022|NCT02068508|"     The purpose of this study is to investigate the safety and efficacy of long-term treatment     with pioglitazone (Actos Tablets) in in the routine clinical setting in combination with     combination with an insulin product in patients with type 2 diabetes mellitus who responded     inadequately when using an insulin product in addition to diet therapy and exercise therapy.   "
93012|NCT02068638|"     Whereas physical activity clearly results in improvements in glycemic control in type 2     diabetes, in individuals with type 1 diabetes (T1DM) the impact of exercise on blood sugar     control is more complex. In type 1 diabetes T1DM the inability to reduce exogenous insulin     levels during exercise is a key factor that contributes to an increased risk of     exercise-induced hypoglycemia. Since rapid adaptation of insulin dosage may be especially     difficult in patients on a multiple daily injection regimen, alternative strategies are     required to improve exercise-associated glucose stability. There is increasing evidence that     the combination of steady state continuous low to moderate intensity exercise with short     bursts of high intensity exertion (eg in the form of sprints) is an effective, well     tolerated, novel strategy to prevent exercise-related hypoglycemia. A further promising     option to stabilize blood sugar levels during and after exercise may be the ingestion of     fructose in addition to glucose in form of a sport drink.   "
93013|NCT02068625|"     This randomised, double-blind, placebo-controlled clinical trial investigates the     neuroprotective effect of rasagiline in patients suffering from a retinal detachment     affecting central vision. Based on results from a study in mice suffering from retinal     degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the     retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a     second-generation propargylamine with neuroprotective properties modulating the     caspase-dependent pathway of programmed cell death.   "
93014|NCT02068612|"     Physiological and neurocognitive changes experienced as a result of increasing age may     influence socioemotional functioning and economic behaviors, yet, the mechanisms through     which these changes occur are not well understood. Studies have also shown that aerobic     exercise may protect against age-related cognitive decline in other domains. This research is     designed to test the hypothesis that aerobic exercise will enhance social, emotional and     economic functioning in older adults, and that these effects will occur via the effect of     exercise on neurocognitive structure and function assessed via magnetic resonance imaging     (MRI). Advancing our knowledge of the mechanisms that influence emotional, social and     economic functioning could inform the development of targeted treatments and prevention     programs for older adults.   "
93017|NCT02068573|"     AsthmaVent is a multi-center study, investigating the association between indoor air quality     and childhood asthma.      In Denmark, we spend more and more time indoors. Our houses are built airtight to save energy     and are difficult to ventilate. We are thus more exposed to our indoor air than ever before.     We know that indoor air contains many different components that can affect our airways     inappropriately and particularly children with asthma, who have sensitive airways are     sensitive to these components. The AsthmaVent project examines whether increased ventilation     is able to improve the indoor environment to such an extent that the asthma disease control,     for children with asthma and house dust mite allergy improves, resulting in need for less     medication.      Previous studies have pointed towards a beneficial effect of mechanical ventilation, on both     the indoor air quality and on children's health and quality of life. There is not currently a     consensus in this area, as studies so far have not been large or good enough to confidently     determine the effect.      This project is big and is designed so that it takes into account the sources of error seen     in previous studies on the topic.      We include, over a 3-year period (2012-2014), a total of 80 children with asthma and house     dust mite allergy aged 6-18 years, from pediatric departments in Aarhus, Odense, Kolding,     Randers and Herning. They are divided into two groups, receiving either active ventilation or     placebo ventilation, meaning a non-functioning ventilation system that just recirculates the     air in the room. Ventilation systems are installed in the fall and winter and ventilate the     child's bedroom during 9 months. Indoor air quality and asthma control are assessed every 3     months, both at home visits were air quality and allergen levels of house dust mites are     studies and at visits to the outpatient clinics with control of asthma parameters and quality     of life.      The project involves collaboration between several institutions with an interest in indoor     air quality in relation to allergies and asthma and with great expertise in the field.The     project was initiated by CISBO (Centre for Indoor Environment and Health in Dwellings), a     center consisting of several institutions in Denmark dealing with indoor environment:     Department of Public Health at Aarhus University and University of Copenhagen, Danish     Building Research Institute and the Technical University of Denmark.      Since asthma is the most common chronic childhood disease in Denmark and since the     development of allergies and asthma has high social and personal costs, it is important for     both society and the individual family, to find out whether simply improving the indoor air     quality by increased ventilation can lead to an improvement in asthma disease control.   "
93018|NCT02068560|"     There is substantial evidence that women throughout life have significantly lower plasma     levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this     is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no     significant difference in renal response parameters was found. This could be interpreted an     increased renal sensitivity in females compared to males. The theory of increased renal     sensitivity in females is supported by a few pharmacodynamic studies currently available on     this topic. However none of the studies was designed with the purpose of investigate the     gender difference.      The aim of this study is to investigate possible gender differences in the renal sensitivity     to dDAVP and the effect of age on these differences. This will be done by low dose graded     infusion of the synthetic AVP analog dDAVP.      Participants are 80 healthy volunteers equally distributed between four age groups, 8-10     years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.   "
93019|NCT02068547|"     The purpose of this research is to test if that combining bone marrow aspirate (removing bone     marrow with a needle) concentration with locally harvested (collected) autograft (patient's     own bone from another part of the body) for use as the bone graft results in equal rates of a     successful procedure (fusion), as compared to current best practice in high-risk patients     undergoing posterior cervical fusion.      Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft     results in equivalent rates of bony fusion, as compared to current best practice in high-risk     patients undergoing posterior cervical decompression and fusion.   "
93020|NCT02068534|"     The current study aims to explore the risk factors, protective factors, resilient factors,     and factors jeopardizing the recovery progress on survivors from charcoal-burning suicide. To     this end, an in-depth individual interview and Mini-Mental State Examination(MMSE) will be     used to acquire the first-hand information on the attempters. As well, a more comprehensive     neuropsychological test, WAIS III, will be administered at 3-month, 6-month, and 12-month     after the index suicide attempt.   "
93021|NCT02068521|"     Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan     administration.      Patients will be monitored for safety throughout their participation in the study. Safety     will be monitored by physical examination, inspection of injection sites, vital signs,     clinical laboratory determinations (including fasting glucose, insulin, and lipids), 12-lead     ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan),     PK/PD assessments, and immunogenicity assessments.      Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using     CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug     dictionary.   "
93024|NCT02068482|"     Diverticulosis of the colon is a frequent condition in adults in western countries and a     significant number of patients experience clinical symptoms even when the diverticulosis is     not complicated by diverticulitis.      Both central and mucosal immunity are altered in Uncomplicated Symptomatic Diverticular     Disease (USDD) and Rifaximin ameliorate clinical symptoms and normalize the immunological     abnormalities.      The Study Protocol is verify the modifications in the immunological pattern induced by     reducing bacteria related activation of immunity by Rifaximin treatment.   "
93025|NCT02068469|"     The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and     assay for detecting Strep A at the point of care lab compared to culture.   "
93026|NCT02068456|"     The purpose of this study is to evaluate the safety and efficacy of roflumilast in the     real-use conditions with its registered indications.   "
93027|NCT02068443|"     The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with     metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2     diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in     addition to diet and exercise therapy.   "
93120|NCT02067234|"     The goal of the current investigation is to determine whether the inclusion of a     parent/patient psychoeducational session in initial dermatology appointments with new     pediatric atopic dermatitis patients affects (a) extent of medical follow-up, (b) patient's     quality of life, and (c) parenting stress in comparison to treatment as usual for initial     pediatric dermatology appointments for new pediatric patients with atopic dermatitis.   "
93028|NCT02068430|"     This study will evaluate the Safety and Effectiveness of the UV-X System for Corneal Collagen     Cross-Linking in Eyes with Corneal Infection. The treatment of UV-X system is to use the     eyedrops of the riboflavin, also known as vitamin B2, and ultraviolet A (UVA) light. The eye     drops are placed in affected eye and then affected cornea is exposed to UVA.      UVA/riboflavin corneal collagen cross-linking was first used to treat patients in 1998 in     Dresden, Germany. Data to date obtained mostly by physicians outside the United States has     strongly suggested this treatment as an acceptable alternative, and many subjects have had a     lasting effect (no progression) 3-5 years after their initial treatment.   "
93029|NCT02068417|"     The objective of the pilot study is to assess the feasibility of a full randomised,     placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application     in patients with erectile dysfunction of vascular origin leads to a greater increase in     potency than in the control group.   "
93030|NCT02068404|"     Preterm birth is the leading cause of perinatal mortality and morbidity. According to WHO, 15     million children are born prematurely (gestational age < 37 weeks) in the world each year     while 7% of them die because of complications associated with prematurity. Despite constant     improvement of obstetrical care, the number of preterm births has increased over the last     decades and prematurity is still the most frequent cause of prenatal hospitalization in     industrialized countries.      The American College of Obstetricians and Gynecologists as well as the Royal College of     Obstetricians and Gynaecologists recommend nifedipine as a first-line tocolytic in case of     acute threatened preterm labour. Clinical experience show however an important variability in     treatment response among pregnant women. In spite of its large use in obstetrics as a     tocolytic agent, nifedipine is prescribed off-label. As a consequence no international     consensus on optimal dose schedule has so far been proposed.      Small sample size and heterogeneousness of tocolysis administration protocols make it     difficult to compare the little data available on the pharmacokinetics of nifedipine in     pregnant women. Nevertheless an important interindividual variability in concentrations has     been identified (CV=12-76%) but very few studies have investigated the possible reasons of     this variability in pregnant women. Genetic and environmental factors involved in drug     distribution and metabolism (e.g. enzymatic activity, CYP 3A5 genotype) might partially     explain variability in drug levels and therefore differences in treatment response.      The goal of this study is to quantify the variability in nifedipine pharmacokinetics and     identify potential genetic and non-genetic sources of variability in nifedipine     pharmacokinetics in pregnant women. The relationship between concentration and treatment     response will be evaluated and will serve to propose optimal dosage regimen to improve     efficacy and reduce side effects associated with this treatment.   "
93031|NCT02068391|"     Silent ischemic, also known as covert stroke vascular disease (CSVD), contributes to     neurological deficits that are caused by damage to small blood vessels in the brain. CSVD     occurs six to ten times more often that an acute stroke. It is misleading to think, however,     that CSVD is an inevitable part of getting old because people with CSVD are at high risk of     developing an acute stroke or dementia. In fact, people with more CSVD lesion volume are more     likely to develop day to day problems in planning, decision-making and speed of thinking.     Unfortunately, there are no proven therapies designed to address CSVD. We propose to test     whether aerobic exercise is an intervention that can combat CSVD because the disease is     fundamentally a blood flow problem that may be improved by aerobic exercise. We will recruit     CSVD adults with moderate to severe lesion burden and use magnetic resonance imaging (MRI) to     study the brain in terms of structure, perfusion and function. Participants will be randomly     assigned to either our established aerobic exercise program or a control stretching program.     Both groups will take part in lab exercise sessions, which are designed to monitor progress     and assess adherence to the program. The duration and intensity of their exercise will     increase as participants progress. We will use activity log books, phone calls and extra     booster exercise sessions, as needed, to maximize retention and adherence. We aim to show     that aerobic exercise increases cerebral blood flow (CBF) in frontal-subcortical grey matter,     supports regional tissue growth, and improves cognitive function in CSVD adults with     substantial risk of acute stroke and dementia. A positive outcome of this research will     provide strong support for additional clinical trials aimed at sustaining cognition and     maintaining independent living.   "
93064|NCT02067962|"     Juvenile idiopathic arthritis (JIA) is considered to be a multifactorial disease caused by a     combination of environmental factors and predisposing genetic factors. Twins studies found a     strong heritability (strong genetic factors) but genetic studies such association studies of     large cohorts of patient (GWAS or Genome Wide Association Study) have elucidated less than 20     % of the genetic basis of JIA. The vision of the genetics of multifactorial diseases has     recently changed revealing a large clinical and genetic heterogeneity of these diseases.     Indeed, the advent of next-generation sequencing identified non-multifactorial genetic     hereditary disease related to mutations in genes having strong effect on the onset of the     disease without real impact of environmental factors among the so called multifactorial     diseases (Parkinson's, diabetes, osteoarthritis, Alzheimer's, hypertension ...)The     investigators propose to study 30 families with several forms of JIA by next-generation     sequencing. Identifying the genetic basis of JIA in these families will help to better     understand the physiopathology of this disease and may help to the identification of novel     therapeutic targets for other patients with JIA.   "
93032|NCT02068378|"     Lung cancer is the second most common cancer in the United Kingdom with around 40,000 new     cases diagnosed every year. Lung cancer is associated with a very poor prognosis (<10%     patient survival at 5 years). New strategies are urgently needed to improve survival in this     group of patients.      The most effective and common treatment for lung cancer is radiotherapy (either alone or     combined with chemotherapy and/or surgery) and generally high doses of radiotherapy are given     to the tumour. However, increasing the radiotherapy dose carries an increased risk of damage     to the surrounding healthy tissue. Damage can be minimised by reducing movement within the     lung, caused by factors such as breathing and patient motion, during treatment.      This study tests a new medical device that has been developed to monitor and help patients     control their breathing and movement during treatment. Optical sensors will detect any motion     of the patient's torso and this will be fed back to the patient in the form of a visual aid     allowing them to regulate their breathing and maintain their ideal treatment position.      The device has already been shown to reduce motion in healthy volunteers. In this study the     investigators hope to demonstrate that the visual aids are tolerable in lung cancer patients.     The investigators additionally aim to show the device will help reduce movements of the chest     and also the lung tumour, leading to improvements in treatment results.   "
93033|NCT02068365|"     This is a multi-center, single-arm, open-label study on the virological response of chronic     HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on     nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate     the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at 24     weeks after the end of treatment.   "
93034|NCT02068352|"     The purpose of this study is to investigate the effectiveness and safety of 2 concentrations     of OPA-15406 compared to vehicle in subjects with atopic dermatitis.   "
93035|NCT02068339|"     Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)     activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1     (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the     development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some     research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in     SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of     lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c.     Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c     pathway in liver.   "
93036|NCT02068326|"     Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in     adolescents younger than 18 years according to the Diagnostic and Statistical Manual of     Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably     diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD     exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly     shown to be effective in treating adult BPD, but in the case of adolescents, only individual     MBT have been tested and found to be effective.      Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory     programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As     Usual (TAU) in treating adolescents with BPD or subthreshold BPD.      Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region     Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V     BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up     will be at three and 12 months.      Discussion: Early intervention is especially important in relation to personality     psychopathology and has long-term benefits for patients, their families and society. In     addition to being cost effective, using the group modality in the treatment of BPD may have     several advantages. This is the first Randomized Controlled Trial (RCT) to test the     effectiveness of MBT in groups for adolescents.   "
93037|NCT02068313|"     Phase II and III studies have demonstrated IMRT to be safe and standard practice for head and     neck cancers treated with radiotherapy. This study will be an extension to an earlier,     in-house, trial to allow continued recording of toxicities and outcomes in patients receiving     IMRT for head and neck cancers. This study will allow us to examine radiobiological modelling     for normal tissue complication probability and in particular, determining the dose threshold     for parotid glands. Our primary objective is to assess the potential effectiveness of     intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer     patients and determining threshold dose for whole parotid gland and superficial lobes of     parotid glands   "
93038|NCT02068300|"     The purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-D-glucitol     (1,5-AG) as a novel surrogate marker of hypoglycemia   "
93039|NCT02068287|"     Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the     inflammatory response. Experimental works demonstrated that Esmolol, an highly selective     beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono     centric, double blind, randomized clinical work in septic shock patients has shown that     Esmolol administration is safe and reduces effectively heart rate. However there are only     sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human     resuscitated septic shock patients treated by esmolol.   "
93040|NCT02068274|"     Opioids are an effective instrument for patients with acute and chronic pain. Their route of     administration ranges from transdermal to subcutaneous application through to Intravenous     Patient-Controlled Analgesia (IV-PCA).      The use of IV-PCA-pumps has considerable advantages including decreased delay in the     administration of opioids from the time requested, individual dose intervals, self -control     of their therapy, rapidity and ease of dose titration . These potential benefits, however are     balanced by the need for careful assessment of adverse effects, including decreased quality     of life because of the patient's sedation, constipation and possible episodes of bradypnoea     and desaturation, eventually leading to respiratory depression (RD) requiring treatment.     Often described safety features that help prevent overdosing are PCA bolus dose, delay, and     lockout interval.      Even though the risk of serious, potentially life threatening complications by using IV-PCA     without a background infusion was described to be very low (0.24%) compared to other methods     of opioid delivery , adverse effects like worrying degrees of hypoxemia and bradypnoea do     occur and often remain undetected due to the lack of continuous monitoring. One of the     possible causes of patient harm are medication errors associated with PCA administration, a     common form of PCA errors, which is a significant source of preventable patient morbidity and     hospital resource utilization.      The individual patient response to a particular dose of opioids depends on diagnosed or     unrecognized comorbidities. Clinical experience has shown that it is not possible to     prospectively identify all patients who may be at increased risk.      Conventional opioid monitoring protocol may fail to detect frequent episodes of bradypnoea     and desaturation measured by the respiratory rate (RR) and Saturation of Peripheral Oxygen     (SpO2) because even at a low respiratory rate SpO2 is usually maintained, so that pulse     oxymetry might fail to detect respiratory deterioration, particularly if a patient is     receiving supplemental oxygen.      Therefore, continuous monitoring could be considered more sensitive, especially if it     contains the measurement of Partial Pressure of Carbon dioxide (PCO2), which is a good     parameter for monitoring ventilatory function.      The 'gold standard' method to measure the arterial partial pressure of carbon dioxide (PaCO2)     is still the arterial blood gas analysis. But arterial sampling including catheterization or     intermittent arterial puncture is invasive and expensive and associated with pain and     discomfort for the patient. Therefore cutaneous carbon dioxide tension (PcCO2) measurement     was suggested to be used as a non-invasive surrogate measure of PaCO2.      SpO2, and tcPCO2, are important clinical parameters that should be used in conjunction with     each other. SpO2 reflects oxygenation, while tcPCO2 reflects ventilation; the first can still     be normal while the second may herald early changes in respiratory status. Capnography may     provide the earliest indication of opioid-induced respiratory depression. It is important to     monitor changes from a baseline tcPCO2 level. As the tcPCO2 level starts to increase, early     intervention and changes in medication can be made.      The present study aims to examine combined oxymetry and transcutaneous capnography using a     single earlobe sensor (V-Sign™, Sentec AG, Therwil, Switzerland) in chronic pain patients     treated with opioids where non-invasive monitoring of ventilation is needed because     ventilatory disturbances are suspected. This may, potentially, improve patient's quality of     life.   "
93041|NCT02068261|"     The purpose of this study is to evaluate the effects of a computerized working memory     training program on substance abuse, psychosocial functioning, cognitive performance and     psychiatric problems in adults with substance abuse and attention problems.   "
93065|NCT02067949|"     determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg)     plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient     from the societal perspective over one year.   "
93066|NCT02067936|"     The investigators study whether four equipotent combinations of propofol and remifentanil (as     predicted by interaction models for tolerance of laryngoscopy) result in identical     haemodynamic conditions, independent of their relative different balance between the     concentration of propofol and remifentanil.   "
93175|NCT02066493|"     The purpose of this study is to generate detailed insight into which therapies of giant     intracranial aneurysms are being conducted, to document the natural history and the outcome     of treatment over 5 years after inclusion into the Registry and to follow imaging data of     giant aneurysms over years after diagnosis.   "
93042|NCT02068248|"     Research over the past several decades have linked the intake of dietary fiber with lower     blood cholesterol levels. The distinction between soluble and insoluble fiber fractions     emerged shortly after and there is now a general consensus that soluble fiber possesses the     capacity to lower cholesterol. Since the discovery of the cholesterol lowering effects of     soluble dietary fiber, there has been much debate as to the degree of cholesterol reduction     from these fibers. In order to handle the inconsistencies a full and systematic review of the     published literature was conducted by Brown et. al (1999). Results from this meta-analysis,     concluded that 'increasing soluble fiber can make only a small contribution to lowering     cholesterol.'      Research is constantly progressing and new research findings may not always be consistent     with older data. For example, results from new research are now challenging the previously     approved health claims for soy foods and fatty acids. This is a major public health concern     because if clinical evidence is not reliable, it could lead to harm. Since the publication of     the meta-analysis by Brown et. al (1999) over a decade ago, scientists have continued to     research the effects of soluble fiber on cholesterol levels with new technology and trial     designs, therefore it is crucial to revisit the question and update the literature on the     effect of viscous soluble dietary fibers on serum cholesterol levels.      A series of meta-analyses will be performed to assess the link between viscous dietary fibers     and serum cholesterol levels. Nutritionists now consider fiber to be an integral part of diet     and disease. Results from these meta-analyses help address the question of whether viscous     soluble fibers have a role lowering serum cholesterol levels.   "
93043|NCT02068235|"     This study consists of a single-dose pilot phase and a randomized, two-way crossover,     single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of     the oral formulation (tablet) of ponesimod compared to an intravenous (i.v.) ponesimod     formulation. Three subjects will be included in the pilot phase and 12 subjects in the main     crossover phase.   "
93044|NCT02068222|"     The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and     ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.   "
93045|NCT02068209|"     The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during     outpatient hysteroscopy.   "
93046|NCT02068196|"     The goal of this study is to understand how ipilimumab is being used, its safety profile, and     the manner in which Adverse Reactions are managed in routine clinical practice. Another goal     is to identify predictive biomarkers. The study is an observational study and not intended to     test any hypothesis, but can be hypothesis generating.   "
93047|NCT02068183|"     The proposed study builds upon preliminary studies in self-selected populations to identify     opportunities for early identification of World Trade Center-related health consequences in     adolescents. If adverse health consequences are identified, proactive cardiometabolic and     pulmonary screening of exposed children may be indicated, with targeted interventions     intended to prevent development of chronic obstructive pulmonary disease, and adverse     cardiometabolic outcomes in adulthood.   "
93121|NCT02067221|"     The objective of this research is to investigate the surgical outcomes of minimally invasive     percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with     renal stone larger than 1cm.   "
93048|NCT02068170|"     A prospective, observational study in a university hospital (UZ Leuven). Patients are     included when they are treated with a potentional QT-prolonging drug: haloperidol for     delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin,     erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole,     voriconazole), methadone, tacrolimus and oral oncolytics.      An ECG is taken before the administration of the drug and 3-5 days after starting the drug to     investigate the change in duration of the QTc-interval. Risk factors for developing     QT-prolongation will be documented. Together with ECG2, an additional blood sample will be     collected to measure the blood concentration of the drug.   "
93049|NCT02068157|"     This phase II trial studies the effects of interstitial photodynamic therapy in patients with     head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination     of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During     treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may     be an effective treatment for head and neck cancer.   "
93050|NCT02068144|"     The purpose of this study is to determine the health benefits of cranberry extract in people     who are at risk for diabetes and heart problems.   "
93051|NCT02068131|"     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor     and anti-virus protein for injection plus capecitabine in treating patients with metastatic     colorectal cancer who have progressed after standard therapy.   "
93052|NCT02068118|"     Targeted population: Patients with heart failure causing hospitalization during the last     twelve months.      Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the     Telecardiology group than for the reference group (standard follow-up care). An 18 months     period of observation is required.      Main goal: To compare the rate of all cause deaths and hospitalizations of patients with     heart failure between the Telecardiology group and the reference group after 18 months of     monitoring.   "
93053|NCT02068105|"     This is a study to test the safety of ALKS 5461 in healthy adults.   "
93054|NCT02068092|"     This is a pilot study is evaluating the effect of hydroxytyrosol, a component of Olive oil,     on mammographic density in women at high risk of breast through assessing whether     mammographic density is reduced in women at high risk of breast cancer taking hydroxytyrosol     for 1 year compared with baseline imaging.   "
93067|NCT02067923|"     This study proposes to conduct a non-interventional, multi-center trial that will look at     C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who     received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal     antibody is a humanized antibody that is commonly used to prevent organ rejection. It was     give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly     diagnosed type 1 diabetes.      The overall hypothesis of this study is there will be less change in c-peptide levels of the     previously treated group versus the control group.   "
93055|NCT02068079|"     The purpose of this study is to evaluate the safety of combination therapy with vemurafenib     and trientine in patients with BRAF mutated metastatic melanoma.      Vemurafenib is a drug that is currently approved by the United States Food and Drug     Administration (FDA) and by the European Medicines Agency (EMA) to treat adult patients with     melanoma that has spread to other parts of the body or cannot be removed by surgery. It can     only be used in patients whose cancer has a change (mutation) in the BRAF gene.      Preclinical data suggests that use of a copper chelator (reducer) is a strategy to block     cellular signaling activity which would result in anti-tumor effects (slow tumor growth).     Trientine is a copper chelator and is FDA approved for the treatment of Wilson's disease (a     disease of copper metabolism) and is generally well tolerated. It works by binding to copper     to help remove it from the body. Trientine is not FDA approved for the treatment of melanoma     and its use in this study is investigational. Investigational means the study drug is still     being tested in research studies.      All patients will receive vemurafenib at 960mg PO twice daily with continuous dosing in     combination with trientine in escalating doses. The dose of trientine will depend on what     portion of the study.      In order to participate in the study, patients must test positive for the change (mutation)     in the BRAF gene.   "
93056|NCT02068066|"     Background: Physical activity is defined as any bodily movement produced by skeletal muscles     resulting in energy expenditure (Caspersen, 1985). According to classical work physiology,     energy expenditure was considered as basis for assessing the severity of manual work     (Grandjean 1991). Steele et. al. found blue collar workers to report significantly more     walking activity, daily step counts and MET min/week than professionals and white collar     workers. However, the energy cost of physical activity may not necessarily be equivalent to     body movement. Therefore, modern concepts include also other aspects reflecting the amount of     workload. Soer et. al. applied an evaluation system consisting 12 work-related tests to     establish functional capacity in healthy employees. The assessment included various lifting     and energetic tasks as well as coordination exercises. In occupational rehabilitation a     balance between workload and work capacity is necessary for professional reintegration. Thus,     it is of great value to evaluate a wide range of work requirements across occupational groups     in terms of energy expenditure, physical activity and aerobic capacity.      Aim: The aim of this study is to examine the amount of physical activity and energy     expenditure during a normal working day with focus on differences between occupational     groups.      Method: To analyze the situation in Switzerland, 300 healthy and full-time employed adults     between 18-65 years will be investigated in the Basel region. Participants will be stratified     by occupational category according to the ISCO-88 and will then be merged into 3 groups with     low-, moderate- and high-intensity occupational activity. By wearing the SenseWear Mini     Armband on 7 consecutive days, average daily energy expenditure, activity duration at     different intensities and step counts will be assessed during work-time. In addition,     individual's aerobic capacity will be determined by the 20-meter shuttle run test.      Outlook: This study is expected to provide detailed information about physical work     requirements with regard to professional reintegration. For developing adequate intervention     and treatment strategies, it is of great value to evaluate performance criteria across     occupational groups.   "
93057|NCT02068053|"     The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and     extent of elimination, as well as safety and tolerability of a single oral solution dose of     [14C] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.   "
93058|NCT02068040|"     The major goal of this proposal is to characterize the ability of epicatechin which a     component of dark chocolate to improve the        1. structural and functional features of skeletal muscle (SkM)        2. exercise capacity (as assessed by VO2 max)        3. parameters of diastolic heart function (as assessed by echocardiography)      We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead     to a significant improvement in exercise capacity and diastolic function.   "
93059|NCT02068027|"     The purpose of the study is to determine whether clonidine gel is an effective treatment for     reducing the pain associated with painful diabetic neuropathy.   "
93060|NCT02068014|"     Sleev gastrectomy is a procedure performed for permanent treatment of obesity. For the     procedure, cutting of the stomach is performed with differents long of stapplers.      The aim of the study is to determine wich long of stappler is applicable in any stage of the     procedure ans the variation expected.   "
93327|NCT02064491|"     The purpose of this study is to determine whether continuing erlotinib beyond disease     progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR     mutant disease or who have responded to EGFR TKI.   "
93061|NCT02068001|"     It has been suggested that obese people are more sensitive to sensory and rewarding effects     of food, aspects that mediate food preferences and intake. Individuals that underwent     Roux-en-Y gastric bypass surgery frequently report changes in food preference. They indicate     a decreased preference for highly rewarding energy dense foods. Changes in food preference     might be related to alterations in central (brain) mechanisms, related to reward sensing. The     smell and sight of food can be considered as anticipatory cues for the rewarding effects of     food intake. The aim of this study is to determine the effect of gastric bypass surgery on     (alterations in) food preferences. Secondly, this study aims at assessing the effect of     gastric bypass surgery on the brain reward response when exposed to sight and smell of food     stimuli with different sugar and fat contents.   "
93062|NCT02067988|"     Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic     disease or are excluded from liver-directed treatment because of extrahepatic disease.     Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic     disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The     efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic     177Lu-dotatate will be studied in a non-comparative phase II study. The study is an     interventional, treatment, non-randomized, open label, non-comparative, phase II study.     166Ho-RE will be performed via a catheter during angiography.   "
93063|NCT02067975|"     Kynurenic acid (KYNA) is a naturally occurring chemical in the brain. Studies with rodents     indicate that levels of KYNA can impact levels of the neurotransmitters glutamate and     dopamine. One way to reliably increase KYNA levels is by ingesting the amino acid tryptophan.     Tryptophan is a normal part of the human diet. Tryptophan gets metabolized/changed to other     chemicals in the body- including KYNA. By giving people 6 grams of tryptophan, the     investigators will be able to increase the KYNA level in a controlled way. The investigators     will then be able to study the effects of KYNA on neurotransmitters by using cognitive tests     and magnetic resonance imaging techniques (measuring brain activity and brain chemistry using     the MRI magnet). They will test people using tryptophan and also using a placebo to look for     differences. The investigators will test healthy controls and people with schizophrenia to     look for differences.   "
93068|NCT02067910|"     Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by     inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the     mouth. Furthermore, many patients experience extraglandular symptoms such as restricting     fatigue. Currently, biological agents have been introduced in various systemic autoimmune     diseases such as rheumatoid arthritis and systemic lupus erythematosus. No biological agent     has yet been approved for the treatment of pSS. In an open-label study, we have shown that     abatacept treatment of pSS patients has promising results (Meiners et al., 2014). Therefore,     the aim of this study is to evaluate efficacy and safety of subcutaneous abatacept treatment     in pSS in a larger and randomized clinical trial.   "
93069|NCT02067897|"     Ingrown toenails occur when the nail grows into the surrounding skin, resulting in pain and     infection. The most common procedure to treat this problem is a wedge excision (removal of     part of the toenail) and matricectomy (destruction of part of the nailbed with chemicals or     surgical instruments). This study will evaluate the effectiveness of an alternative technique     called the Vandenbos procedure (where the skin is removed and the toenail is left intact).     This procedure is currently being used by some of the pediatric surgeons at our hospital and     we want to evaluate our results up to 6 months after surgery. We believe that the true     recurrence rate will be greater than 0% but that recovery time and morbidity will be     acceptable to most patients.   "
93070|NCT02067884|"     This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in     measuring response in patients with breast cancer receiving chemotherapy before surgery. New     imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may     predict treatment response earlier and more accurately than contrast enhanced magnetic     resonance imaging.   "
93071|NCT02067871|"     -  The purpose of this study is to determine the effects of low-level laser therapy in          combination with neuromuscular electrical stimulation on neuromuscular (muscular          strength and morphology) and functional parameters (pain and functional tests) in          elderly with knee osteoarthritis.        -  The hypothesis is that the association of low-level laser therapy with neuromuscular          electrical stimulation could reduce joint pain associated with the inflammation and          consequently potentiates the effects of electrical stimulation on the muscular system.   "
93072|NCT02067858|"     The goals of this clinical research are to evaluate the outcomes and tumor response for early     stage non-small lung cancer (NSCLC) patients undergoing Stereotactic Body Radiation Therapy     (SBRT) using four dimensional (4D) Positron Emission Tomography (PET) and Computed Tomography     (CT), Cone-Beam Computed Tomography (CBCT), Real-Time Position Management (RPM™) and body     immobilization system (see figure 1). Specifically, the effect of image-guided SBRT treatment     on clinical tumor response rate, local control and progression-free survival will be studied.     This study will examine target volumes and relevant margins determined by an assessment using     4D PET and repeated 4D CT. These data will allow us to evaluate and determine the impact of     the body immobilization system on the planning target volume (PTV) margins, patient's     breathing pattern, target motion, and inter-treatment targets shifts.   "
93073|NCT02067845|"     The limited research that exists suggests that lesbian, bisexual and queer (LBQ) women are at     similar risk for sexually transmitted infections (STI) as heterosexual women. This is a     particularly important area to address, as literature highlights the convergence of sexual     stigma and gender-based sexual violence as elevating LBQ women's risk for HIV and STI     infection. However, recent Statistics Canada data indicated that: lesbians reported     significantly lower rates of Pap testing than heterosexual or bisexual women; lesbians and     bisexual women had higher odds of not having a regular doctor than heterosexual women; and     bisexual women had higher reported unmet health care needs than lesbian and heterosexual     women. These differences highlight the importance of implementing and evaluating     interventions to address STI risk among LBQ women; however, no published study exists of this     nature. A STI prevention intervention will be implemented with groups of LBQ women and WSW in     Toronto and Calgary. The study has 5 distinct components: 1) key informant interviews to     inform the development of the intervention training manual and survey questionnaire, 2)     pre-test; 3) intervention (6 group sessions during a weekend retreat); 4) post-test directly     following intervention, and 5) follow-up post-tests at 6 and 12 weeks. The study hypothesis     is that, compared to pre-intervention, participants who receive the group-based intervention     will report an increase in sexually transmitted infections (STI) knowledge post-intervention.     The secondary hypotheses are that, compared with pre-intervention, participants will     demonstrate higher mean scores of (a) safer sex self-efficacy; (b) STI testing; (c) safer sex     practices; (d) resilient coping, (e) self-esteem, (f) social provisions, (g) community     connectedness and (h) access to health care. We anticipated that compared to     pre-intervention, participants post-intervention would report lower mean scores of (a)     depression and (b) internalized stigma.   "
93074|NCT02067832|"     Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and     contributes significantly to morbidity and mortality in stem cell transplantation patients.      The research will look into identifying and validating cGVHD biological indicators     (=bio-markers) which will be evaluated whether they can predict a future development of the     disease.      The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be     present at the time of cGVHD diagnosis, will also be present at earlier time points, before     cGVHD develops.      Following validation, the bio-markers will be beneficial for finding those patients who are     in higher risk to develop cGVHD.      By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive     therapy might be applied in order to prevent or reduce the prevalence of the disease.   "
93075|NCT02067819|"     The purpose of this study is to assess the feasibility of a trial on an oral orthotic for     reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic     Disorder (CTD).   "
93076|NCT02067806|"     The present study aims to evaluate the relationship between spinal block with 1% solution of     2-chloroprocaine hydrochloride and the onset of all possible neurological adverse events,     with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome     (CES).   "
93077|NCT02067793|"     The purpose of this study is to evaluate the efficacy and safety of NRX-1074 following a     single intravenous dose in subjects with major depressive disorder.   "
93089|NCT02067637|"     Hypotheses and Specific Aims: There is limited data on the long-term consequences of cancer     therapy on young, reproductively aged cancer survivors. The investigators objective is to     characterize some of these effects in the cancer population.   "
93090|NCT02067624|"     The purpose of this study was to investigate the effect of Thai massage on pressure pain     threshold, pain intensity, wrist range of motion, grip strength and patient satisfaction in     patients with wrist extensor muscles latent Myofascial trigger points.   "
97102|NCT02015208|"     The purpose of this study is to determine if Ruxolitinib, an inhibitor of cytokine-signaling,     is effective in the treatment of patients with Chronic Lymphocytic Leukemia for whom     conventional chemotherapy is either too toxic or ineffective.   "
93078|NCT02067780|"     Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the world.     In a recent study, we showed that administration of levofloxacin is superior to placebo in     the treatment of decompensation of COPD; it is accompanied by a substantial reduction in     mortality and a significant reduction in the residence time in hospital.      In Tunisia, few data are available on the epidemiology of COPD decompensation. The choice of     antibiotic to be used in this situation is challenging to the clinician who must choose     between traditional antibiotics (cyclins, aminopenicillins, cotrimoxazole...) and new     antimicrobial agents. Recently, it has been emphasized the selection of patients for     treatment according to the degree of systemic inflammation (C-Reactive Protein). Indeed,     there would have a correlation between the tracheobronchial infection and elevated     inflammatory markers. As the elevation of these markers is proportional to the intensity of     the inflammatory reaction of the body, is based on the kinetics of these biomarkers in     antibiotic treatment seems logical. Thus, C-Reactive Protein allowed not only knowing when to     start antibiotics, but also through their kinetic, these markers can guide the duration of     therapy and shorten the duration of antibiotic therapy: a rate cut would ensure that the     antibiotic treatment was adopted.      The objectives of this randomized prospective and double blind study are to evaluate the     efficacy and safety of a short treatment of 48 with levofloxacin compared with treatment with     the same molecule during a time guided by monitoring markers of inflammation in patients     admitted to the emergency for exacerbation of COPD and to study the epidemiology of viral and     bacterial COPD decompensation.   "
93079|NCT02067767|"     Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable     regimen on the long-term. However this regimen comprises 2 pills per day.     Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per     day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP)     of high potency, higher genetic barrier to resistance, with a very good safety profile. The     objective of this study is to evaluate the virologic safety (maintenance of virologic     suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults     with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory     safety. Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK)     assessment will be performed in all patients in the first weeks after switch and 24-hours PK     in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching     to ABC/3TC/DTG.   "
93081|NCT02067741|"     SAKK 21/12 is a stratified, multicenter Phase II first in-human trial with transdermal CR1447     (4-OH-testosterone) and is directed to patients with endocrine responsive-HER2neg and     TN-ARpos metastatic or locally advanced breast cancer.      The trial will be conducted in Switzerland with max. 90 patients. CR1447 has a very good     safety and tolerability profile and combines two mechanisms of action, interaction with the     AR and the aromatase enzyme may have a higher activity than drugs with a single mechanism and     might offer the possibility of non-chemotherapy based endocrine therapy to the limited     treatment options in TN-ARpos BC. Transdermal application of CR1447 might have the advantage     to continuously release of 4-OHT into the blood stream, thus omitting a first pass effect.      In Phase II the main objective is to assess activity and to determine the efficacy and     tolerability of CR1447. Phase II will consist of two strata, into which patients will be     stratified according to their hormonal receptor status: Stratum A for patients with endocrine     responsive-HER2neg disease, regardless of their AR status and Stratum B for patients with     triple-negative and determined ARpos disease. Patients with triple-negative disease tested     negative for AR will be excluded from the trial.      In both strata patients will be treated with 400 mg of CR1447 until disease progression,     patients' wish or physicians' decision to end treatment. Biopsies of one defined metastatic     lesion in those patients who gave informed consent will be performed at baseline and within     the third week of treatment with CR1447.      Measurement of AR expression, expression of downstream targets of ERα, ERβ, PR, AR,     angiogenesis and other translational studies as described in this protocol should help     confirming the hypothesis of an increased benefit of CR1447 due to its dual action, efficacy     of topical application, tolerability and in deciding whether one should proceed to a large     randomized trial.   "
93082|NCT02067728|"     The main aim of the study would be to examine the effect of using a health behavior screening     tool and a brief patient centered conversation on health behavior goal setting during     well-child visits.   "
93083|NCT02067715|"     Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth     sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique     reduce the tooth sensitivity when compared to conventional technique, without alters the     bleaching efficacy.   "
93084|NCT02067702|"     Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will     examine the effects of non-pharmacological limb cooling on clinical and physiological     characteristics in patients presenting with ET at three different temperatures; and will     measure changes in tremor amplitude after cooling of the upper limb.   "
93085|NCT02067689|"     This study will evaluate the influence of non-invasive brain stimulation on different     elements of cognitive function in healthy persons between the ages of 18-90 years. It will     specifically use transcranial direct current stimulation (tDCS) to evaluate the relationship     between certain brain structures and cognitive abilities, like attention, working memory,     visual search, etc.   "
93086|NCT02067676|"     The purpose of this study is to assess the safety of increasing doses of a potential vaccine     against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This     study will also assess immune responses induced by the vaccine.   "
93087|NCT02067663|"     The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form     of contraception. The postpartum period is an important moment for contraceptive     intervention; however there are many barriers to women obtaining birth control postpartum.     The use of the IUD in the immediate postpartum setting offers many advantages and is     considered safe, but the risk of expulsion appears to be higher than with interval insertion.     Previous studies have shown the rate of expulsion of the copper IUD in the postplacental     period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel     IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While     studies related to the copper IUD use ring forceps or the operator's hand for placement of     the IUD, the only published study investigating immediate postplacental levonorgestrel IUD     insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore     ask the question, is there a difference in expulsion rates between levonorgestrel and copper     IUDs placed post-placentally when all providers undergo a standardized training, use a     standardized insertion technique, and when patient level characteristics are controlled by     randomization?      The investigators propose to perform a prospective cohort trial comparing the rates of     expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the     uterus within 10 minutes of the delivery of the placenta, using a standardized technique     (placement with a ring forceps or the operator's hand) after all providers undergo a formal     didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has     a higher rate of expulsion as compared to the copper IUD. Additional objectives include a     comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized     expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the     investigators will document the natural history of the location of the IUD within the uterus     when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks,     and 3 months postpartum, to better understand the relationship between position of the IUD     and subsequent expulsion.   "
93088|NCT02067650|"     Hardly any imaging studies specifically addressing the articular and periarticular structures     in MPS patients are available at this point. The investigators propose to do for the first     time a pilot study using musculoskeletal ultrasound in patients with various types of MPS.   "
93091|NCT02067611|"     This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled,     parallel group, proof of concept, and dose range finding study to evaluate the efficacy,     safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate     OA of the knee.      Objectives of the study:        1. To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in          subjects with osteoarthritis (OA) of the knee;        2. To assess the safety and tolerability of multiple doses of X0002 when administered as a          topical spray.   "
93092|NCT02067598|"     The purpose of this study is to determine the effect of scapular exercise on pain related     parameters including pain intensity, 24 hours pain intensity, pressure pain threshold,     anxiety and muscle tension in patients with scapulocostal syndrome.   "
93102|NCT02067468|"     Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human     papillomavirus (HPV) infection. These abnormalities have been historically detected by     cervical cytology, but recent evidence shows that HPV testing is superior to cytology to     detect cervical lesions that eventually will progress to cancer. Despite evidence,     conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is     recommended as a triage test for women with atypical squamous cells of undetermined     significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+     but higher than healthy population, and therefore it is important to provide appropriate     clinical management. However, there is no consensus of how to deal women with ASC-US and     therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2)     repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of     this study is to compare the effectiveness and the efficient among the strategies as well as     to evaluate the acceptability of the HPV testing in a real-life setting.   "
93093|NCT02067585|"     Bariatric surgery induce remarkable weight loss and improvement or resolution of type 2     diabetes. Obesity is the primary risk factor for type 2 diabetes, and 90% of all type 2     diabetics are obese. Type 2 diabetes resolves post-operatively in 84-98% after bypass and     48-68% after restrictive procedures.      Obesity leads to elevated plasma free fatty acids and subsequently to excessive accumulation     of triglyceride in peripheral tissues, which is an independent risk factor for insulin     resistance and type 2 diabetes. Bariatric surgery is associated with dramatic decrease in     plasma free fatty acids and other lipids.      This study will clarify the relationship of changes in fatty acid and other lipid metabolism     to improved insulin sensitivity after different bariatric procedures ('restrictive' -     laparoscopic adjustable gastric band and 'hybrid' - laparoscopic roux-en-y gastric bypass)     and compare them with non-surgical obese patients. This will allow the investigators to     refine indications for these procedures especially in patients with type 2 diabetes.      The investigators will analyze whether surgical bypass of the upper small bowel plays a     critical role in the resolution of type 2 diabetes and improvement in lipid metabolism. The     investigators will achieve this by comparing gastric banding and gastric bypass in a     collaborative research study involving obesity surgeons, physicians and lipid researchers.   "
93094|NCT02067572|"     This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining     good oral health among patients in palliative care. It is hypothesized that using the     mouthwash made from salvia will result in better oral health and more oral comfort than using     with conventional normal saline mouthwash.   "
93095|NCT02067559|"     The main objective of the study is to test the feasibility of the ICU diaries intervention in     the ICU. The investigators do not have sufficient power to detect differences in the     hypotheses below, but will use the present pilot study to inform sample size required to     adequately power a follow-up randomized control trial.      (1) The investigators hypothesize that subjects exposed to a psychoeducation condition will     have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing     treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in     the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those exposed     to both ICU diary + psychoeducation conditions, will have significantly reduced rates of PTSD     at follow-up. (3)The investigators hypothesize that participants exposed to the ICU diary +     psychoeducation condition will have significantly lower rates of PTSD compared to those in     the ICU diary alone condition.   "
93096|NCT02067546|"     Emptying disorders are of the most common causes of constipation. An adjustable toilet seat     was designed by  Shva-Nach Ltd company, and is designed to facilitate the angle sitting     position.      Its efficacy will be evaluated in the current study, on 50 volunteers who suffer from     constipation and meet the Rome 3 criteria for constipation.   "
93097|NCT02067533|"     The purpose of the present study is to determine the influence of position of soft tissue     repair (flexion versus extension) in post operative range of motion(ROM) and functional     outcome in patients who underwent primary total knee arthroplasty (TKA).   "
93098|NCT02067520|"     Introduction:      Cesarean section (C/S) is usually performed under spinal with preservative free morphine for     pain relief, but the investigators have a severe shortage of this formulation of morphine.     Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has     been used in spinals for postoperative pain relief and in pain pumps for relief of chronic     pain. No randomized controlled studies have evaluated intrathecal (IT) hydromorphone for post     C/S pain.      Methods:      This is a randomized double-blind controlled trial utilizing the up-down sequential     allocation method1,2 to find the best dose of IT hydromorphone that provides pain relief     following C/S. Patients will be given a morphine PCA pump for additional pain relief. Our     first patient will receive 200 mcg of IT hydromorphone. Pain, nausea, and itching will be     evaluated at 4, 8, 12 and 24 hours following the C/S via numeric rating scales; vomiting and     morphine use per hour will be recorded. Success will be a median morphine usage of less than     or equal to 1mg/hour in the following 16 hours. If a success, the next patient will be given     10 mcg less IT hydromorphone; if a failure, she will receive 10 mcg more. The study will end     after 5 successes.      Objective:      The primary objective is to find the optimal dose of IT hydromorphone for pain relief     following C/S. The secondary objectives are to define the incidence and severity of     hydromorphone's side effects and determine the duration of analgesia.   "
97978|NCT02003716|"     The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA     as a primary anamnestic from to identify subjects at risk of osteoporosis in a population     never screened before and never treated for this disease.   "
93099|NCT02067507|"     The primary aim of the project is to increase human papillomavirus (HPV) vaccine receipt     rates among low-income, ethnic minority adolescents (girls and boys 11-17 years of age) in     Los Angeles County. We will accomplish this goal by implementing and rigorously evaluating     interventions in multiple venues that serve our target population, including the Los Angeles     County Department of Public Health (LACDPH) and two large Federally Qualified Health Centers     (FQHCs).      Our hypotheses are:      Primary hypothesis:        1. The intervention group will have a higher rate of HPV vaccine initiation at follow-up          compared to the control group.           Secondary hypothesis:        2. The intervention group will have higher vaccine completion rates (3 doses) at follow-up          compared to the control group.   "
93100|NCT02067494|"     The purpose of this current randomized clinical trial is to determine the effects of     myofascial soft tissue release and kinesio taping on disability, pain, quality of life,     autonomic nervous system and oxidative stress indicators in chronic low back pain.   "
93101|NCT02067481|"     This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and     cardiorespiratory fitness after a diet and physical activity intervention in breast cancer     survivors and to asses possible relation between these changes.   "
93114|NCT02067312|"     The purpose of this study is to determine the effect of Thai massage on pain related     parameters including Pain intensity, 24 hours pain intensity, Pressure pain threshold,     anxiety, muscle tension, cervical range of motion, pain frequency, patient satisfaction and     side effect in patients with chronic upper back pain associated with myofascial trigger     points   "
93115|NCT02067299|"     The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to     persistent sleep) in participants with major depressive disorder who are stably treated with     selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer     from insomnia (inability to fall asleep).   "
93103|NCT02067455|"     Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths,     1% of public health expenditure each year in France. Heart transplantation remains the     standard of care in patients for which medical therapy is not sufficient. But heart     transplantation is a limited resource, as a result of donor shortages. It is therefore     possible to consider mechanical circulatory support for patients awaiting heart     transplantation or for those who are not suitable for transplantation. Left Ventricular     Assist Devices (LVAD) are portable pumps which help the left side of the heart to provide     appropriate cardiac output. in this type of device, right heart is not assisted and must     work on its own, LVADs are thus implanted in patients whose right ventricular function is     normal.      The aim of the REVADE study is to assess right ventricular echocardiographic parameters in     this population, especially on physical exercise, for a better understanding of right     ventricular adaptation to this long-term modified pressure pattern.   "
93104|NCT02067442|"     Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores     when given preoperatively. This study investigates if there is a difference between the     intravenous and the oral forms when given preoperatively to patients undergoing lumbar     microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores     or decrease opioid consumption during the first postoperative day compared to the oral     formulation.   "
93105|NCT02067429|"     This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI) in     correcting astigmatism in patient undergoing standard cataract surgery.      Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical.     Uncorrected astigmatism of greater than approximately 0.75 diopters (D) can cause visual     blurring, ghosting of images or halos. Over 20% of patients undergoing cataract surgery have     astigmatism which is likely to have been corrected by spectacles.      Cataract surgery involves the replacement of the natural opacifying crystalline lens with a     clear artificial plastic intra-ocular lens (IOL). The lens power can be selected to correct     the patient's glasses prescription. The most widely used IOLs only correct glasses at one     distance i.e. either near or distance. Residual astigmatism after cataract surgery will need     glasses for correction which is undesirable for many patients.      Limbal relaxing incisions (LRI) are circumferential partial thickness cuts to the clear     window of the eye (cornea) during surgery. These LRIs can correct corneal astigmatism and     have no additional risk of complications.      Alternatively, toric IOLs are available which correct astigmatism inside the eye. They have     been available for routine use in the last few years; technology has markedly improved and     the lenses have become cheaper.      Studies have suggested toric IOLs provide better vision after cataract surgery than the     regular IOLs. Toric IOL are widely used in the private practice and increasingly in the     National Health Service (NHS). LRIs are cost effective for treating astigmatism however their     predictability is believed to be lower than toric IOLs. As there are no randomised controlled     trials comparing the outcomes between LRIs and toric IOLs. This research will address this     gap in knowledge and accordingly from this research future practice will be able to provide     treatment to patients with information about the best outcomes.   "
93106|NCT02067416|"     Study of the assay, Mammostrat®. to verify its utility as a predictor or outcome tool to     determine whom would benefit from chemotherapy prior to surgery. Also could be used as a     clinical marker to identify patients with breast cancer who do not benefit from some     preoperative chemotherapies.   "
93107|NCT02067403|"     Pressure support (PS) is a commonly used mode of ventilation which is triggered based upon     the patient's own inspiratory efforts. For the most part, pressure support is well tolerated     by patients. However, because the trigger for pressure support is an inspiratory effort by     the patient, and because the resulting support is constant, the ventilator response can be     out of sync with the patient's needs. The problem of patient-ventilator asynchrony has been     documented to be large in approximately one quarter of patients who require mechanical     ventilation. Asynchrony is associated with increased or abnormal work of breathing (WOB) and     prolonged duration of mechanical ventilation. Diagnosing asynchrony at the bedside can be     challenging. Electrical activation of the diaphragm (Eadi) recording can provide clinicians     with a more accurate picture of patient-ventilator synchrony and may thus result in decreased     asynchrony and decreased or normalized work of breathing for the patient. The purpose of this     physiologic study is to evaluate the role of protocolized pressure support ventilation (based     upon Eadi) in comparison to standard pressure support ventilation.   "
93108|NCT02067390|"     Acute renal injury is a common complication of critical illness. Drug induced renal insult     compounds the degree of injury in many patients, and a great deal of research has focused on     prevention of this complication. Traditional biomarkers of renal injury like serum creatinine     and blood urea nitrogen content fail to consistently predict harm among patients at risk.     Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.   "
98341|NCT01998958|"     The purpose of this study is to assess the efficacy and dose response of intranasal     esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with     placebo in improving depressive symptoms in participants with treatment-resistant depression     (TRD).   "
93109|NCT02067377|"     This study will evaluate the use of a medical food, oral serum-derived bovine     immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a     wasting syndrome) improve their nutritional status and gain weight. The medical food is in     powder form and is mixed with a liquid such as water or orange juice and consumed by     swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the     nutritional status of cachexic patients with advanced stages of COPD.   "
93110|NCT02067364|"     An exploratory Fit & Function study of Continuous Real Time (CRT) ShuntCheck, a     non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in     hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins     Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize     device design.   "
93111|NCT02067351|"     There is evidence that mindfulness-based interventions (MBIs) such as meditation,     mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and     reduce stress in breast cancer survivors. These interventions are becoming increasingly     popular in cancer survivors. However, little is known about the feasibility and effect of     MBIs administered during the interval of time of chemotherapy, on QOL and stress. The     investigators are planning a MBI intervention study developed specifically for breast cancer     survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for     at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving     chemotherapy for breast cancer.   "
93112|NCT02067338|"     The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in     postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind,     placebo-controlled study   "
93113|NCT02067325|"     The purpose of this study is to determine the effect of Thai massage on electromyogram in     patients with chronic upper back pain associated with myofascial trigger points.   "
95537|NCT02035631|"     The main purpose of our study is to assess the effect of a lifestyle intervention combining     weight control, diet and physical activity on the risk of recurrences among breast cancer     patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.   "
93122|NCT02067208|"     Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these     insoles typically reduce knee abduction moments (KAM) - a variable associated with knee     osteoarthritis - and thus are believed to be beneficial for OA management, recent research     has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In     such cases, a medial wedge may be more appropriate.      The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months     for patients with knee OA. It is hypothesized that pain reduction will be directly related to     KAM reduction.      Forty-six participants with knee OA will be recruited to participate. Each will undergo     biomechanical gait analysis to determine the wedge type that most greatly reduces knee     adduction moments. In addition, each participant will undergo a Dual Energy X-Ray     Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series     of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury     history. Participants will be randomized into either a wait list control group (no insole) or     experimental group (medial or lateral wedged insole), and monitored for 3 months.      Changes to pain, function, comfort and physical activity from baseline to 3 months will be     assessed within the control and experimental groups. Regression analyses will be conducted on     the experimental group to determine if a relationship exists between reduced KAMs and reduced     pain over 3 months. Comparisons will also be made between the control and experimental     groups.   "
93123|NCT02067195|"     To compare the efficacy of 2 different hydration strategies, hydration according to clinical     guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI     undergoing primary PCI to investigate the possible beneficial role of periprocedural adequate     hydration.   "
93124|NCT02067182|"     Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of     atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC     in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm     JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in     these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the     ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent     cerebral embolic events in patients with a high risk for embolic events, free from AF after     successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration     of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation     of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score     ≥2 after the first pulmonary vein ablation for paroxysmal AF.   "
93125|NCT02067169|"     Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5%     of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol     studies. This prevalence vary with the organ transplanted and the degree of viral replication     and immunosuppression. Less data are available to date from real-life cohorts of patients,     and there is no systematic survey of resistance in Europe or in the US. Non response to     treatment concerns a larger group of patients and can result either from emergence of a     resistant strain (virological resistance), from inadequate dosage of antivirals, or a high     degree of immunosuppression, with a poor CMV immune response. The respective clinical impact     of virological resistance and clinical resistance (of pharmacological or immunological     origin) on graft outcome and long-term survival of patients has never been assessed. High     viral loads and persistent replication associated to prolonged exposure to antivirals are     known to favor the emergence of resistant strains. Though epidemiology of resistant strains,     role of multiple infections, impact of various mutations on degree of resistance to     antivirals and outcome remains to be further studied. Most studies are per-protocol studies     or short-term studies conducted on limited populations. There are no data in real-life of     transplanted patients at the era of enlarged prophylaxis except those from the French survey     for cytomegalovirus resistance cohort opened at the end of 2006. From the first data     collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of     virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer     outcome in case of virological resistance and to the absence of impact of prophylaxis versus     preemptive therapy, though larger populations and prolonged follow-up are requested to     fulfill all objectives.      We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large     number of patients and a prolonged follow-up, to gather data on resistance to antivirals in     real-life of transplant patients in an organized data bank, This cohort is in the continuum     of our previous cohort started in 2006, granted by the Hospital Clinical Research Program     Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.   "
93145|NCT02066909|"     This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in     healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days     (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese     healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the     safety/tolerability and PK data from the Western and Japanese populations.   "
93126|NCT02067156|"     Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50%     of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical     debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to     improve second-line therapy in GBM have met with only marginal success and there is a large     unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug     chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is     expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM,     but not by normal cells or blood vessels in normal tissue. It is believed that activation of     the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the     activity, safety and CNS exposure of G-202 in patients with recurrent or progressive GMB     receiving G-202 by intravenous infusion on three consecutive days of a 28-day cycle. Funding     Source - FDA OOPD   "
93135|NCT02067039|"     This study seeks to determine the public health impact of providing rapid HIV test kits to     men who have sex with men (MSM) so they may test themselves at their convenience. The study     will determine if men who receive the rapid HIV test kits report HIV testing at least three     times per year. This study will be conducted in four consecutive parts. The first three parts     are formative in nature to guide the development and implementation of Part 4 of the study.     The research study will use two different types of rapid HIV tests. The OraQuick® In-Home HIV     Test for oral fluid (FDA approved for home use) and Sure Check® HIV 1/2 Assay, currently     FDA-approved for professional use and distributed in the U.S. as Clearview® Complete HIV-1/2     Rapid Test. An Investigational Device Exemption will be obtained from the FDA to allow the     contractor to supply the Sure Check® HIV 1/2 Assay to study participants since it is not     approved for home use.   "
93136|NCT02067026|"     Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic     risk profiles and gut microbiota in subjects with high BMI      Primary objectives of the trial are to evaluate whether wheat Aleurone-rich food     supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary     metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile     acid and fecal sterol concentrations.      Secondary objectives are to evaluate whether wheat Aleurone-rich food supplementation     modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total     cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin     levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of intestinal     permeability in plasma; (8) inflammation      Study Design Placebo-controlled, randomized, double-blind parallel trial Criteria for     Enrollment Inclusion criteria: Aged 18-65 years; BMI >27 kg/m^2. Good General health.      Exclusion criteria: Fasting blood glucose >300 mg/dl; triglycerides >500 mg/dl; uncontrolled     hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long     term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic     substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco     smoking.      Methodology After a run-in phase of two weeks, participants will be randomized to receive     supplementation with either wheat Aleurone-rich food (27 g Aleurone/day) or placebo for 4     weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be     performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S.     di Dietetica e Nutrizione Clinica, St Chiara, Trento. Clinical tests, blood drawing, and     stool and urine collection will be performed during visits at the beginning and end of each     treatment period (T0 and T1) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento.     A 4 day-food diary record will be collected before visits T0 and T1.      Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food     questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL     cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14, LPS-binding     protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal microbiota     analysis.      Safety Assessments. Adverse events.      Statistical analyses. Post-intervention data will be compared by ANOVA using the General     Linear Model with baseline as a covariate. Data with a skewed distribution will be log     transformed before analyses. Simple and multiple linear regression will be used to determine     relationships between variables and independent t-tests performed to evaluate differences in     reported compliance between groups. Results will be expressed as mean +/- SEM and differences     will be considered significant at P < 0.05..      Duration of Dosing. Subjects will make three visits during the study (start of run-in phase -     visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week 6).     Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is     targeted.   "
93166|NCT02066610|"     The objectives of the study were to assess the serum selenium, zinc, and copper status and     plasma and white blood cell antioxidant enzyme activities of low birth weight infants     receiving selenium supplemented and non-selenium supplemented parenteral nutrition from     initiation of parenteral nutrition until discontinuation of preterm formula or hospital     discharge.   "
93128|NCT02067130|"     In patients with hereditary anemias (e.g. thalassemias), defective red blood cells are     produced due to an error in the genes, or DNA, that provide the instructions for their     synthesis. As a result, hereditary anemias are characterized by chronically low hemoglobin,     which is contained inside red blood cells and carries oxygen throughout the body. In more     severe cases, patients are dependent on frequent blood transfusions to replenish the     hemoglobin.      The body has limited ability to get rid of excess iron. However, with repeated blood     transfusions, the iron level in the body builds up because the red blood cells contain iron     as heme. Over time, the high level of iron accumulates in organs such as the heart, liver,     and pancreas causing heart problems, liver failure, and diabetes. As a result, patients who     receive multiple blood transfusions need to be monitored for iron overload, and be started on     medical therapy in a timely fashion to prevent organ damage.      Liver is usually the first and the most affected organ by iron accumulation, so knowledge of     its iron concentration provides estimate of total body iron load. Liver biopsy is the gold     standard in measuring the iron concentration in the liver, but it is invasive and cannot be     performed on routine basis. MRI is another option that can assess liver iron concentration     non-invasively, and is currently recommended for monitoring iron load on a yearly basis.     However, MRI has a high cost and is not easily accessible in Canada. The investigators aim to     determine if transient elastography (Fibroscan), which is a form of ultrasound that measures     liver stiffness, can accurately assess liver iron concentration.      Hypothesis:      Fibroscan reading correlates with MRI and serum ferritin in estimating hepatic iron     concentration.   "
93129|NCT02067117|"     This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC     FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot   "
93130|NCT02067104|"     This study is a single site double blinded Phase II study to evaluate the chemopreventative     effectiveness of vismodegib in the treatment of subjects at high risk for developing basal     cell carcinomas (BCC).   "
93131|NCT02067091|"     Patients presenting with acute ST elevation myocardial infarct urgently need     revascularization. Standard of care is establishing bloodflow through the coronary vessels     using thrombus aspiration catheter, and securing the result by using a metallic drug eluting     stent. New kinds of non-metallic bioresorbable stents are now available. They have however     challenges in structural strength.      The investigators want to compare the new bioresorbable scaffold with traditional metallic     stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120     patients. The investigators will use an imaging technique, optical coherence tomography, to     evaluate the results after 12 months.      The investigators also want to see if modern multislice computed tomography can give useful     information in the follow-up of stented coronary arteries after 12 and 24 months.   "
93132|NCT02067078|"     Purpose:      The purpose of this study is to evaluate the postoperative analgesic effect of a combined     Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the     tissue around the knee after surgery with knee replacement. In the combined nerve blocks we     use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone (protracted mixture)     and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is     that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain     and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and     lethargy compared to the current treatment with local infiltration analgesia.      Background:      Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven     procedure. The nerve blocks have the disadvantage that not only do they anesthetize the     sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve     block causes only stunning of sensory nerves to the knee region. The Obturator nerve block     causes both stunning of the sensory nerves to the knee region and the thighs inward leading     muscles, and does not affect the patient's mobilization capacity.      Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a     well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in     other studies, in addition to the local anesthetic agent, and has been shown to prolong the     effect of the nerve block. Saphenous and Obturator nerve block with all four drugs     Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated     in knee replacement surgery, and it is not known whether this method will provide better pain     treatment.      Method      The patient can receive one of three treatments, determined randomly:        -  A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline,          Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine          (normal saline).        -  B. Saphenous block with active anesthetics and both Obturator nerve block and local          block around the knee joint with placebo medicine (normal saline).        -  C. Both block with placebo medicine (normal saline) and local block around the knee          joint with effective local anesthetic.      Neither patient, investigator or staff around the patient will have knowledge of which     treatment the patient has received.      The blocks will be injected before the operation and local infiltration around the knee joint     will be given by the surgeon during the operation.   "
93146|NCT02066896|"     This study was designed to test the efficacy and safety of low laser therapy to treat the     xerostomia of patients with primary Sjogren's Syndrome.   "
93133|NCT02067065|"     Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the     administration of propofol by non-anesthesiologists, despite moderate quality evidence that     support its' use.      There is only one small trial of a direct comparison of propofol sedation by     anesthesiologists versus non-anesthesiologists.      Our aim is to compare the incidence of sedation related adverse events, the procedural     quality indicators, times (onset, recovery, discharge) and patient satisfaction between     non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist     propofol sedation.      A randomized clinical trial with the incidence of sedation related minor adverse events as     primary endpoint will be conducted. Secondary endpoints include procedure quality indicators,     propofol dosage and patient satisfaction.      A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90%     power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events     incidence, estimated from our pilot experience. The sample size was adjusted for a 2%     cross-over rate.      Informed and consenting patients undergoing colonoscopy examinations will be randomly     assigned to one of two arms. One group will be sedated by an anesthesiologist according to a     protocol of propofol mono-sedation. The other group will be sedated with propofol boluses,     according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a     3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained     in NAAP and exclusively dedicated to sedation and patient monitoring.   "
93134|NCT02067052|"     Vulvar cancer is a rare disease that is treated with surgery, radiation and chemotherapy.     When tumors are large (greater than 4 cm) or compromise the urethra (urine canal) and the     anus, or when it is in the groin lymph nodes, surgery alone is not always able to be     performed. In this circumstance, is necessary to add radiotherapy, chemotherapy or both .      So far it is not known the best sequence of treatment: surgery, chemotherapy or radiotherapy.     The radical surgeries usually need long recovery term both in the region of the vulva and in     the region of the groin lymph nodes. When it is performed, convalescence can delay other     treatments, like radiotherapy and chemotherapy. On the other hand, the use of radiotherapy     and chemotherapy as a first step treatment can result in a complete elimination of the     disease in at least 30% of the cases or substantial reduction of its size, allowing less     extensive surgery.      Investigators intend to use surgery, chemotherapy and radiotherapy in the treatment of vulvar     cancer, but in a sequence that has not been studied, in order to increase benefits of these     treatments, and reduce morbidity.      This study will be offered to patients who have disease of the vulva less than 4 cm (sentinel     lymph node), or greater than 4 cm, or illness that compromises urethra and anus, or patients     with disease in groin lymph nodes (glands).        1. On the eve of the surgery, investigators will inject dextran-70 labeled with          technetium-99 m. Only patients with tumors smaller than 4 cm will do this procedure.        2. On the day of the surgery, the groin lymph nodes will be removed from the inguinal          (groin) only. If lymph nodes are disease positive, the vulvectomy will not be performed          at this time. Patients will be treated with radiation therapy with concomitant          chemotherapy for approximately six weeks.        3. At the end of treatment with chemotherapy and radiotherapy, investigators will perform a          surgery to remove the remaining tumor in the vulva.   "
93137|NCT02067013|"     Clinical Retina research studies often collect aqueous samples in hopes of estimating levels     of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous     correlate. This study will collect vitreous and aqueous samples at the same time to evaluate     and compare drug and cytokine levels.      The overall objective of this study is to evaluate the molecular concentration of growth     factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from     individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to     proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to     macular degeneration, macular hole or neovascular glaucoma.   "
93138|NCT02067000|"     Validation of the patient perception questionnaire relating to CPAP use   "
93139|NCT02066987|"     the present study had two main aims. First, due to the current underconsumption of dental     brush adolescents, the investigators should apply a volitional intervention to increase oral     health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness     of action planning intervention and implementation intention will improve oral health     behavior in adolescents.   "
93140|NCT02066974|"     Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients     were presented with advanced disease. Percutaneous ethanol injection, radiofrequency     ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a     curative treatment and have achieved very limited success in eradicating large HCC or tumors     causing portal vein thrombosis. With the development of novel radiotherapy (RT) technique, RT     can be safely given to patients with larger tumor or portal vein thrombosis. However, RT     could achieve a tumor response rate of approximately 50 %. Currently, there was a paucity of     studies regarding a quantitative biomarker to predict tumor response or forecast the outcome     in advance. To optimize the therapeutic index, there is a need to seek effective biomarkers     for personal medicine because pretreatment AFP is not always useful as a surrogate marker in     some of the patients.      The present study is to investigate whether circulating tumor cell genome in peripheral blood     can be used to predict RT response in HCC. We will use the blood sample from patients with     locally advanced HCC receiving RT. By using next generation sequencing, We are going to     explore the quantity and quality changes of DNAs and RNAs in the patient's serum or plasma.     By this way, genomic expression in peripheral blood may play a key role in determining the     optimal therapeutic strategies for HCC patients by predicting tumor response to RT.   "
93141|NCT02066961|"     The purpose of this study is to describe patterns in disease management and to describe     clinical outcomes, as well as to identify factors influencing physician treatment decisions     including reason(s) for treatment choices and trigger(s) for treatment changes and to     document healthcare resource utilization used to manage treatment-related complications.   "
93142|NCT02066948|"     About two-thirds of adults in the United States are overweight or obese with likely adverse     health consequences. A Moderate weight loss by dieting and exercise is recommended to improve     health. We are interested to know whether eating dietary protein at different times of the     day influences changes in body composition, muscle and indices of health. The purpose of this     study is to examine the effects of within-day patterning of dietary protein intake (even vs.     skewed) on energy-restriction and resistance training-induced changes in body composition,     muscle size, appetite, and clinical health (including blood glucose and blood pressure).   "
93143|NCT02066935|"     The purpose of this study is identify the prevalence of non-adherence to immunosuppressives     in Brazilian renal transplant recipients, identify the factors related to non-adherence in     the studied population and identify the prevalence of non-adherence in the different regions     of the country.   "
93144|NCT02066922|"     The purpose of this study is to compare the change from baseline in central corneal curvature     at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.   "
93147|NCT02066870|"     The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably     develop acquired resistance. A great deal of research are focusing on this issue. Arsenic     trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and     other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the     resistance of tumor cells to chemotherapy and TKIs.   "
93148|NCT02066857|"     The purpose of this prospective randomized study is to add to the body of knowledge on the     treatment of minimally displaced distal radius fractures in patients over 60 years of age.     The investigators believe that treating minimally displaced distal radius fractures in people     over 60 with a removable splint and early range of motion will provide greater patient     satisfaction, fewer complications, and earlier functional returns to pre-injury for these     patients compared to those treated with a short arm cast which immobilizes the limb for at     least four weeks, and has been shown to lead to longer recovery and possible residual     stiffness. The investigators hope to provide sufficient evidence in directing treatment that     will give the most efficacious and the most satisfactory return of prior function to     patients. Since distal radius fractures in the elderly are common because of poorer bone     quality, the elderly proportion of the population is increasing, and controlling health costs     is of current concern, answering the question of which treatment produces the best results     for all these concerns is of increasing importance now.   "
93149|NCT02066844|"     The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study     is to collect data to compare the comfort and patient satisfaction of a hip injection     delivered via the Navigator compared to a standard needle injection. In addition, delivery     preparation will be compared between a Navigator injection and a standard hip injection. The     data collected from this pilot study will serve as the basis to design a larger multi-center     study.   "
93151|NCT02066818|"     Local anesthesia used for incision and drainage of abscesses is known to be painful.      We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable     lidocaine during incision and drainage (I&D) of skin abscesses.      Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine     patch during I&D of skin abscesses in the Emergency Department. Pain at presentation and     following the procedure was similar in both groups.   "
93152|NCT02066805|"     This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries     and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate     assessment of prescriptions and diagnoses, especially those related to cancer patients during     the first year post the initial market availability of XGEVA.   "
93153|NCT02066792|"     The purpose of this study is to examine the efficacy of 50 mg of d-cycloserine in comparison     to placebo (a pill containing no medication) for improving the effectiveness of     cognitive-behavioral therapy (CBT) in reducing symptoms associated with social anxiety     disorder. In addition, the study will examine whether the effectiveness of d-cycloserine     depends on the timing of the pill administration (i.e., 1- hour before the session or     immediately after the session) as well as the success of the CBT therapy sessions. The     investigators hypothesize that the tailored post-session DCS administration condition will     outperform the other conditions (pre-session DCS, placebo, and non-tailored post-session     DCS). This will be evidenced by short- and long-term improvements in social anxiety severity.   "
93154|NCT02066766|"     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the     current status of diabetes management, control, and complications in diabetic subjects in     Vietnam.   "
93155|NCT02066753|"     This PhD study is a sub study in a randomized clinical controlled multicenter trial named     TTH48 (ClinicalTrials.gov Identifier: NCT01689077).      The TTH48 trial examines prolonged mild therapeutic hypothermia (MTH) at 32-34°C in 24     versus 48 hours with the primary outcome Cerebral Performance Category after 6 month in     comatose out-of-hospital cardiac arrest patients.      THE OVERALL AIM OF THIS PhD STUDY IS TO INVESTIGATE THE CARDIAC FUNCTION AND THE HEMODYNAMICS     BY BIOCHEMICAL CARDIAC MARKERS, ECHOCARDIOGRAPHY, BY ANALYZING THE USAGE OF     INOTROPES/VASOPRESSORS AND BY ANALYZING ECG DATA FOR ARRHYTHMIAS IN THE 24 VERSUS 48 HOURS     MTH GROUPS.   "
93156|NCT02066740|"     The purpose of this study is to collect acute confirmatory data to evaluate technical success     and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery     system.   "
93157|NCT02066727|"     Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective     concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of     bladder tumor   "
93158|NCT02066714|"     Hand Foot and Mouth Disease (HFMD) is a common infectious disease in childhood. Several     enteroviruses are associated with the disease. However, since 1997, large outbreaks of HFMD     in Taiwan, Malaysia and Vietnam have seen unusual neurological complications such as     brainstem encephalitis with rare fatal outcomes. The pathogen associated with this severe     disease is Enterovirus 71.      In 2011, Vietnam had a large outbreak of Hand Foot and mouth disease resulting in 110,000     cases and 164 deaths. HFMD affects children during their early years of child development,     but there is limited information on what the potential long-term consequences are. Small     studies have suggested language and cognitive difficulties in more severe disease but this     has not been evaluated in a large cohort.      Internationally recognized and standardized assessment tools are not available for early     childhood in Vietnam. This project will translate and adapt the Bayley Scales of Toddler and     Infant Development 3rd edition (Bayley III) and Movement ABC, 2nd edition (MABC) into     Vietnamese as outcome measures.      This study will evaluate whether there are neurodevelopment difficulties following severe     HFMD. The study design is a prospective observational cohort study. Hospitalised children     with a clinical diagnosis of HFMD will be eligible to enroll. Written parental consent will     be required. Participants enrolled will be assessed 3 times over 18 months from discharge     from hospital into the study. Since there is no standardization of Bayley III or MABC for     Vietnam, a healthy cohort, age and sex matched to the least severe HFMD participants will be     recruited. This healthy cohort will follow the same assessment program over 18 months. A     total of 350 HFMD participants and 150 healthy children (matched to the least severe HFMD     participants) will be recruited.   "
93159|NCT02066701|"     This study is to identify potential markers from esophageal biopsies and brush cytology for     feasibility of use in stool specimens for detection of Barretts Esophagus.   "
93160|NCT02066688|"     Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and     methylation reactions as well as calcium and vitamin D are assumed to be effective in the     prevention of colorectal polyps and Colorectal cancer (CRC). The aim of this study is to     investigate the roles of FA as well as calcium and vitamin D in the prevention of CRC.   "
93161|NCT02066675|"     Phase II, non-randomized, two-stage study according to Bryant & Day The study enroll patients     with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard     chemotherapy (doxorubicin/epirubicin and/or ifosfamide)   "
93162|NCT02066662|"     The following trial hypothesis will be proved: In patients with atrial fibrillation and/ or     pulmonary embolism standard anticoagulant treatment with coumadin/phenprocoumon is associated     with accelerated coronary or valvular calcification as assessed by cardiac computed     tomography compared to the new anticoagulant therapy with rivaroxaban.   "
93163|NCT02066649|"     Subjects will be those individuals greater than 18 years of age with a diagnosis of cirrhosis     undergoing screening for esophageal varices. Eligible subjects will have a diagnosis of     cirrhosis and esophageal varices (graded as medium or large) with no prior history of     variceal bleeding. The diagnosis of cirrhosis will be based on clinical, radiologic, and/or     laboratory data. Patients will be randomly assigned using electronic medical records to one     of three treatment arms after screening esophagogastroduodenoscopy (EGD) has been performed     and large varices are identified. Primary outcome of the study will be the incidence of     variceal bleeding in patients receiving one of the following therapies for primary     prophylaxis of variceal bleeding: carvedilol, variceal band ligation (VBL), or both     carvedilol and VBL.   "
93164|NCT02066636|"     The purpose of this study is to estimate the incidence and characterize the outcome of high     grade, select adverse events in subjects with advanced or metastatic NSCLC treated with     Nivolumab.   "
93167|NCT02066597|"     Venous thromboembolism (VTE) is a common condition that occurs when a clot develops in one of     your veins. It affects 5% of the population and is the third most common circulatory     condition after heart attack and stroke. People who experience a clot in their vein can have     significant long term problems with swelling and discomfort. The investigators call this post     thrombotic syndrome (PTS). They can also be at increased risk of having another clot occur.     People who have ilio-femoral clots are more likely to have more severe leg swelling and pain     than those who have clots in smaller veins. They are also more likely to have problems     returning to their normal daily routines and may need more hospital visits.      The current standard of care involves treating patients with anticoagulants (blood thinners)     because it has a low risk of bleeding risk and is inexpensive. Blood thinners prevent the     clot from growing bigger while your own body dissolves the clot over time.      The type of clot you have is the most severe form of DVT. Some experts advise early removal     of the clot - resulting in symptom relief sooner and possibly reducing the risk of PTS. This     is in addition to the standard treatment with blood thinners.      There are currently two options for physically removing these clots. One method involves     placing an intravenous catheter into your leg and injecting medication directly where the     clot is situated. This dissolves the clot. This method is called Catheter Directed     Thrombolysis (CDT). The second method, Percutaneous Mechanical Thrombectomy (PMT), involves     placing an intravenous catheter into your leg and breaking down the clot mechanically and     suctioning it out of the vein - creating good blood flow again to your leg. Both methods     require injection of contrast dye and a special x-ray machine to see where the clot is and     ensure that the entire clot is removed.      CDT is very expensive and has an increased risk of major bleeding. PMT is much less expensive     and has a lower risk of bleeding. The doctors at The Ottawa Hospital do not typically     recommend CDT, nor do we commonly perform PMT for this patient population here.      The investigators would like to enroll 26 participants with ilio-femoral DVTs and perform PMT     to see if they can achieve better outcomes than for those who have just had our routine     treatment of blood thinners. The investigators are only conducting this study here at The     Ottawa Hospital, General Campus. They will follow the progress of participants for 6 months.     The device the investigators are using (Angiojet Ultra Thrombectomy System) is already     approved by Health Canada for this procedure.   "
93168|NCT02066584|"     The importance of glucose in culture media on fertilization and embryo development is still     controversial. Although it has been reported that glucose is essential for fertilization     process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of     glucose in culture media may cause developmental arrest of cleavage stage embryos. The aim of     this retrospective study is to examine whether exposure of sibling oocytes to different     concentrations of glucose in culture media has any further effect on IVF outcome.   "
93169|NCT02066571|"     Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's     disease patients, this is to confirm and further investigate the safety and efficacy using a     similar dose. The possible beneficial effects on cognition in mildly cognitively impaired     Parkinson's disease patients will also be tested, since this problem in Parkinson's disease     may be associated with decreased brain synthesis of norepinephrine (a neurotransmitter     associated with multiple brain functions).      During this 11 week study, droxidopa will be slowly titrated up to 600 mg daily. Walking and     freezing of gait will be evaluated and rated. Cognitive functions will be evaluated by a     computer-based program.   "
93170|NCT02066558|"     In this study the investigators will research the hypothesis that the gas carbon monoxide     induces headache and increases the blood flow velocity in the middle cerebral artery.   "
93171|NCT02066545|"     The primary objective of this study is to evaluate the safety and efficacy of once-daily     topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel     in subjects with inflammatory acne vulgaris   "
93172|NCT02066532|"     The purpose of this study is to examine the safety and efficacy of Ruxolitinib in combination     with Trastuzumab in treatment of HER2 positive metastatic breast cancer. Ruxolitinib (Jakafi)     is an Food and Drug Administration (FDA) approved treatment for myelofibrosis (a disease of     the bone marrow), but its safety and efficacy in breast cancer patients is not known.     Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer. The     safety and efficacy of both treatments given in combination is not known. It is hypothesized     that Ruxolitinib in combination with Trastuzumab will demonstrate efficacy in treating     Metastatic HER2 Positive Breast Cancer subjects, and will have a tolerable safety profile in     this patient population.   "
93173|NCT02066519|"     The purpose of this study is to demonstrate that a 3 months physical exercise programme     improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized     since at least 6 months under prednisone and/or azathioprine.   "
93174|NCT02066506|"     the first purpose of the study is to determine the adaptative mechanisms of right ventricle     (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital     heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms     are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives     are to evaluate these mechanisms using echography, arterial properties study and     neurohormonal levels   "
93176|NCT02066480|"     Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and     deterioration of bone microarchitecture , leading to increased fracture risk for low trauma,     such as spinal fractures or femoral neck .      It is estimated that 3 million people are living in France , particularly women , with an     incidence that increases with age .      This disease is a major public health issue in terms of morbidity and mortality , costs and     risk of recurrence (after a first fracture episode) , including risk factors are identified.      However, although bone densitometry is a reliable diagnostic tool and preventive treatments     are at our disposal, screening for osteoporosis is still insufficient .      The objective of our study is to improve the detection of osteoporosis in Hospital     Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone     densitometry or if risk factors are found. Based on the results , the patient will be sent in     rheumatology consultation for implementation of treatment if necessary .      Therefore included women hospitalized in medical services , gynecology, surgery and     orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women     who could answer a simple questionnaire and those previously treated for osteoporosis or have     already received a bone density there is less than 3 years old .   "
93231|NCT02065739|"     The purpose of this study is to assess the effects of repeated administration of 200 mg of     itraconazole on the single-dose pharmacokinetics of JNJ-42165279 in healthy male     participants.   "
94254|NCT02052375|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of     two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with     Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of     ASP2408.   "
93177|NCT02066467|"     The objective of this study is to collect clinical data on safety and performance of ACUITY     X4® leads when used in a standard clinical setting.      It is a prospective, non-randomized, observational multicenter study evaluating standard of     care.      For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse     events and basic parameters of the lead will be assessed. The cohort of subjects included in     this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to     receive an ACUITY X4® lead implant.      Study endpoints:      Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate     of freedom from loss of function or operative system revision due to unacceptable PNS     threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months     post-implant.   "
93178|NCT02066454|"     To evaluate:        -  the incidence of venous thromboembolic event (VTE)        -  the incidence of hemorrhagic complications, In a population of patients with myeloma who          are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral          anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day   "
93179|NCT02066441|"     The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly     individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D     level, bone formation, resorption, and mineral density, flexibility, balance, general     inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the     continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders     thought to now be related to low levels of vitamin D, which are some of the leading disablers     and killers of Americans. Americans also have difficulties with compliance to prescription     medications due to their toxicity and side effects. This study aims to learn more about how a     vitamin D nutritional supplement may improve nutritional status and enable the body to     normalize system functioning,which may improve the quality of life for people with vitamin D     deficiency. The results of this research will be used to determine if vitamin D is beneficial     for overall health among elderly individuals.   "
93180|NCT02066428|"     Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range     finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile     females.   "
93181|NCT02066415|"     To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly     migraine days   "
93182|NCT02066402|"     This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra     venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily     I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection     (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all     subjects.   "
93183|NCT02066389|"     This is a randomized, double-blind, parallel-group, placebo controlled, multicenter study to     assess the safety and efficacy of ABT-494 in subjects with active rheumatoid arthritis who     have failed Methotrexate alone.   "
93184|NCT02066363|"     Clinical background: Weight loss is a common problem in patients suffering from     gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with     weight loss is worse than that for weight stable patients. Malnutrition in cancer patients is     associated with a poor prognosis and is an important predictor of mortality. Supplementation     with home parenteral nutrition in aphagic and terminal patients has shown improved quality of     life, energy balance, body composition and prolonged survival.      Aim: The aim of this study is primarily to study the effects of supplementation with     parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean     body-mass and body composition. Patients found to be at nutritional risk will be included in     the study and will be randomized to either best supportive nutritional care or best     supportive nutritional care and supplemental Parenteral Nutrition.      Design: This study is a controlled, randomized trial with two parallel study arms. The study     will include patients with advanced GI cancers at nutritional risk, performance status 0-2     and with an expected survival of a minimum of 3 months.      A total of 100 patients are planned to be enrolled and randomized to either best supportive     nutritional care or best supportive nutritional care and supplemental parenteral Nutrition.      Primary endpoint is improvement of lean body mass, and by that improvement of quality of     life, performance status and cancer treatment tolerance.      Discussion: The planned study will provide important information about the effect of     parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative     treatment strategies are set up to improve quality of life as well as prolongation of life.     Parenteral nutrition in this patient group may indeed contribute to both these aspects of     palliation.   "
93193|NCT02066246|"     The aim of our study is to investigate if the use of the AirSeal insufflation system impairs     the lung function of patients less than a conventional system in patients undergoing     robot-assisted laparoscopic radical prostatectomy (RALP). Therefore we examine the lung     function before and after surgery.      As a second purpose of the study, in a subgroup, we investigate the influence of the gas     insufflators (AirSeal and conventional) on hemodynamics during surgery. Furthermore we study     the change in the lung perfusion-ventilation-ratio by using the electric impedance tomography     technique.   "
93194|NCT02066233|"     The purpose of this study was to evaluate whether a disposable nasal endoscope called E.G.     Scan II will visualize the esophagus as well as the standard test, sedated endoscopy.   "
93185|NCT02066350|"     Patients accepted for the waiting list for single pancreas transplantation suffer from severe     glucose instability with hyperglycemia due to diabetes type 1, but do not have significant     diabetes-related complications. Pancreas transplantation restores normoglycemia in diabetes     type 1 patients with unstable control of glycemia. Both hypo- and hyperglycemic events are     abolished, and 70-80 % of the patients obtain satisfactory HbA1c levels (HbA1c 5.0-6.0 %)     without the need of exogenous insulin. Endothelial dysfunction is considered as an early and     potentially reversible stage in the atherosclerotic process. The endothelium is involved in     homeostasis, leucocyte adhesion and vasomotor activity. Reduced endothelium-dependent     vasodilation is associated with increments in cardiovascular risk factors, and endothelial     dysfunction is a predictor for future cardiovascular disease. It has also been hypothesized     that endothelial dysfunction may be involved in the impaired glycemic control by reducing the     availability of glucose in peripheral muscles.Establishing normoglycemia by pancreas     transplantation alone in previously diabetic type 1 patients has recently been shown to     improve left ventricular ejection fraction, assessed by Doppler echocardiographic     examination. In diabetic patients receiving a new pancreas it is possible to assess the     effect of changing blood glucose excursions on cardiovascular risk factors, including     endothelial function, without the use of antidiabetic drugs (exclude pleiotropic effects).      The primary objective of the present study is to assess if endothelial function (assessed by     flow-mediated dilatation of arteria brachialis) is improved when hyperglycemia is reversed by     single pancreas transplantation in patients with type 1 diabetes.      Secondary objectives are to investigate the changes in the following parameters by reversal     of hyperglycemia by pancreas transplantation; Peripheral arterial tonometry, serum/plasma     concentrations of endothelial dysfunction markers, blood pressure, lipid and lipoprotein     concentrations.   "
93186|NCT02066337|"     To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional     periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and     superoxide dismutase (SOD) activity in patient with chronic periodontitis.   "
93187|NCT02066324|"     The purpose of this study is to collect urine samples from patients with fibrodysplasia     ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease     progression and for prediction of flare-ups of the disease. Disease related biomarkers in     these patients are currently unknown. This study aims to support the development of novel     therapy/ies for this disease.   "
93246|NCT02065544|"     This is a study of the effects of weight loss and exercise training on glucose control as     measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes.     Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months.     Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of     inflammation. The study hypothesis is that the program of weight loss and exercise will put     >50% of individuals into remission of their type 2 Diabetes as measured by a HBA1c of <     6.5%.   "
94255|NCT02052362|"     A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in     combination with each other and Ritonavir(r).   "
93188|NCT02066311|"     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease in which the body's immune     system attacks different parts of the body. SLE is characterized by inflammation that leads     to tissue damage in different organ systems. Any organ system may be involved, including the     skin, the joints, the kidneys, the nervous system, the heart, the lungs, and the blood. The     exact cause of SLE is not known. Patients with SLE often have elevated levels of anti-double     stranded DNA antibodies. These levels are often associated with disease flares and disease     severity. These antibodies can bind to tissue leading to organ damage. Preventing these     antibodies from binding to their targets may help decrease disease activity.      Protease inhibitors are medications that have been approved by the Food and Drug     Administration (FDA) for use in the treatment of HIV (human immunodeficiency virus).     Nelfinavir (also called viracept) is one of these protease inhibitors. Separate from their     anti-viral effects, protease inhibitors have been found to decrease inflammation. These     medications have been shown to interfere with binding of anti-double stranded DNA antibodies     to their targets and may decrease inflammation in SLE. This research study tests whether the     protease inhibitor, nelfinavir, will decrease anti-double stranded DNA antibody binding and     decrease disease activity.   "
93189|NCT02066298|"     Because approximately half of all mild-moderately-severe asthma is persistently     non-eosinophilic, it is important to determine prospectively if patients who are persistently     non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to     patients who are not persistently non-eosinophilic.   "
93190|NCT02066285|"     Phase II, open-label, non-randomized, international multicenter clinical trial with two     strata (SFT and EMC). 8 sites in Spain, 5 sites in Italy and 5 sites in France. Patients will     receive oral pazopanib at 800 mg once daily continuously. Patients will continue to receive     treatment until there is evidence of progressive disease, unacceptable toxicity,     non-compliance, withdrawn consent or investigator decision. The main goal is to determine the     objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) in     patients with unresectable, locally advanced or metastatic solitary fibrous tumor and     extraskeletal myxoid chondrosarcoma, using Choi and RECIST 1.1 criteria respectively.   "
93191|NCT02066272|"     Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of     Inflammatory bowel disease. Their common features include high efficacy but also     immunogenicity and increased infection risk. Since 2013, two generics or biosimilars of the     first anti-TNF have been registered in Europe, which long lerm safety profile needs yet to be     established.      This prospective, multicenter, observational cohort study will assess safety of treatment of     anti-TNF monoclonal antibodies in inflammatory bowel disease patients in Poland.      Eligible are consecutive patients in whom anti-TNF is started for Crohn's disease, ulcerative     colitis or indeterminate colitis between January 1st, 2014 and December 31st, 2015. Data to     be collected include demography, Montreal classification, indication to treatment, previous     treatment, operations, extraintestinal manifestations and concomitant diseases. Data on     response, tolerability and safety of anti-TNF and on concomitant treatment will be collected.     Adverse events logs will be completed. Majority of IBD centres in Poland, pediatric and     adult, academic and regional, have agreed to participate in the study.      As a result of the study, the frequency of adverse events in a cohort of Polish IBD patients     on various anti-TNFs will be established.   "
93192|NCT02066259|"     The OctavaColon tests are qualitative plasma tests that are indicated to people above 18     years of age suspected with colon abnormality. The blood tests will provide additional     information to the doctor in the course of colon cancer diagnosis for both normal population     and high risk population   "
93223|NCT02065843|"     This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina     mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of     asymptomatic, impacted mandibular third molars.   "
93195|NCT02066220|"     The study PNET 5 MB has been designed for children with medulloblastoma of standard risk     (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With     the advent of biological parameters for stratification into clinical medulloblastoma trials,     the ß-catenin status will be the only criterion according to which study patients will be     assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The     initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for     study entry are the same for both treatment arms.   "
93196|NCT02066207|"     The purpose of this study is to evaluate a pharmacokinetic drug interaction between     atorvastatin and fenofibrate in healthy subjects.   "
93197|NCT02066194|"     Endoscopic ultrasound (EUS) has evolved to become an important diagnostic tool and its     interventional role is rapidly expanding. In order to improve patient's comfort and     satisfaction during and after procedure, the use of sedation is usually recommended. However,     sedation may be associated with serious adverse events of including hypotension, aspiration     and respiratory depression. Moreover, the cost of performing the procedure would be increased     due to the costs of the medications and the need of additional personnel in monitoring of the     patient. As a result, the drive to seek alternative and safer approaches of pain-relief     during EUS is ever present. Electroacupuncture (EA) has been used in Traditional Chinese     Medicine (TCM) for more than 2000 years. The benefits and success of EA in treatment of acute     and chronic pain of various origins have been well-recognised. Many researches have been     performed to address the role of EA in treating pain and anxiety during OGD and colonoscopy.     However, only limited data is availabe in the Chinese and the Western literature concerning     the use of EA in EUS. Therefore it is worthwhile to conduct a well-designed study to evaluate     the role of EA in treating pain during EUS.   "
93199|NCT02066155|"     African Americans are twice as likely to have diabetes compared to their White counterparts     and experience higher rates of diabetes-related complications. Diabetes-related health     disparities underscore the need for effective, culturally tailored approaches to promote and     sustain diabetes self-management over time. Diabetes self-management education (DSME) is     effective in improving diabetes outcomes in the short-term. However, many adults with     diabetes cannot sustain achieved improvements without continued follow-up and support. The     2012 revisions of both the National Standards for Diabetes Care 6 and the National Standards     for DSME and Support emphasize the importance of providing both initial DSME and on-going     diabetes self-management support (DSMS) to assist people with diabetes in maintaining     effective self-management throughout a lifetime. While a great deal is understood about how     to provide effective, initial DSME, less is known about who, where, when, and how to provide     effective, sustained DSMS. One significant challenge is that DSME is a covered benefit in the     healthcare system, while DSMS is not. This ultimately limits access and availability of DSMS     programs, especially for low-income African Americans. Accordingly, there is critical need to     develop, evaluate, and understand effective DSMS models that are ongoing, patient-driven, and     embedded in the community.   "
93200|NCT02066142|"     Hypothesis The study aims to demonstrate at least equivalence, or non-significant difference     between TS and US in women with dense breast screened negative at 2D Mammography.      If the equivalence between TS and US will be demonstrated, US may be substituted by TS with     great benefits for the patients and for the healthcare resources.      Aims        1. Assess if TS may detect additional cancers in dense breast that approximate US detection          capability but with less false positive findings than US.        2. If TS detects new cancers in dense breast similarly to US (approximate rate or          marginally lower rate), evaluate the the true positive/false positive ratio.        3. Cost-analysis. In case of less false positives detected by TS, the true-positive / false          positive trade-off might be strongly in favour of TS with a great potential of costs          reduction.   "
93201|NCT02066129|"     The objective of this study is to determine whether, in children receiving low-dose inhaled     corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of     symptoms previously associated with upper respiratory illnesses and subsequent asthma     exacerbations reduces the rate of severe asthma exacerbations treated with oral     corticosteroids.   "
93202|NCT02066116|"     The investigators have developed the kinect-based upper extremity rehabilitation program and     designed this protocol to prove the efficacy of this program.      In brief, subacute stroke patients allocated to intervention group will receive the kinect     based-rehabilitation program plus conventional occupational therapy and patients allocated to     control group will receive the sham virtual rehabilitation plus conventional occupational     therapy, for 10 days.      20 patients with subacute stroke will be allocated into each group and after completing the     10 days intervention, they will be assessed by using objective assessment tools for upper     extremity function.   "
93203|NCT02066103|"     Assess the safety and feasibility of local oncological drug delivery into the bronchial wall     after recanalization of subjects with malignant airway obstruction. Safety and feasibility     (technical success) will be assessed.      This localized delivery is intended as an adjunct therapy and all subjects will receive     standard of care oncology therapy as determined by their treating physicians.   "
93204|NCT02066090|"     This research is planned to build a basis about the effect of acupuncture on serum metabolic     parameters in pre-menopausal obese women with economic evaluation.   "
93205|NCT02066077|"     1. To determine the influencing factors of modified electroconvulsive therapy (MECT);        2. To determine the influencing factors and reversibility of the cognitive impairment          caused by MECT;        3. To determine the duration of efficacy of MECT and its affecting factors.   "
93206|NCT02066064|"     The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition     colonoscopy with that of standard high definition colonoscopy.   "
93207|NCT02066051|"     The purpose of this study was to see if Intense Pulsed Light (IPL) can be used safely and     effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host     disease (GVHD). Current treatment options for this disease are limited.   "
93224|NCT02065830|"     The aim of this study will be to evaluate the safety and the efficacy of a new robotic     exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other     neurological disease with an impairment of lower limbs.   "
93225|NCT02065817|"     This is a pilot study to determine the optimum time and dose to draw blood samples using a     tracer for HDL kinetics.   "
93208|NCT02066038|"     EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, has been recommended as the     first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients'     progression-free survival. The OPTIMAl trial indicated that those who received TKI and     chemotherapy during the whole treatment window survived longest. Unfortunately, previous     studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed     to improve survival in unselected patients. To avoid the potential synergistic antagonism,     the FAST-ACT II trial committed a sequential strategy and find a superiority in the     combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the     continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could     obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.      On the basis of these and other studies, the investigators hypothesized that a better     sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out     window before chemotherapy) would be more efficacious than chemotherapy alone. In this study,     the investigators investigate the efficacy(PFS:progression free survival), safety, and     adverse-event profile of chemotherapy plus intermittent and maintenance of erlotinib, when     these drugs were used as first-line treatment in who had non-squamous lung carcinoma with     EGFR gene mutation in China.   "
93232|NCT02065726|"     Nutritional derangements are very common in cancer patients and negatively affect survival,     morbidity and quality of life. Intervention trials have demonstrated that nutritional     counseling can improve energy balance, nutritional status and quality of life in patients     undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of     cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events     such as an impairment of nutritional status and quality of life. The nutritional properties     of whey protein have recently raised attention. In view of the high content in cysteine these     proteins can positively stimulate the synthesis of glutathione which, in turn, could     contribute to the modulation of whole-body and cellular redox state. However, evidence on the     role of this dietary intervention in cancer patients is limited.   "
93209|NCT02066025|"     Octava has two versions, each with a different intend of use.      OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized     clinical laboratories. The product is used for two following indications:        -  Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed          mammography and were determined negative for breast cancer. Being moderately sensitive          (>55% sensitivity) the test is able to detect 55% of mammography false negatives. In          addition, being highly specific (>95% specificity) it supplies additional evidence for          true mammography negative result which will reduce examinees anxiety of being          misdiagnosed as a result of high false negative mammography rate (10-30%)        -  Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed          biopsy after positive mammography and the biopsy result was negative. Being moderately          sensitive (>55% sensitivity) the test is able to detect 55% of biopsy false negatives.          In addition being highly specific (>95% specificity) it supplies an additional evidence          for true biopsy negative result which reduces examinees anxiety of being misdiagnosed.      OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx     authorized laboratories. Intend of use of OctavBlue is the following:      • OctavBlue is indicated for women above 18 years old, who performed mammography and received     doubtful results. Being highly sensitive (>95% sensitivity) the test can help to reveal 95%     of positive cases; and being moderately specific (>55% specificity) - about half of negative     cases. The test is not intended to be used as a standalone diagnostic technique but to supply     additional information to a physician and help deciding about the further course of     diagnosis.   "
93210|NCT02066012|"     Dysmetabolic iron overload syndrome (DIOS), is a frequent hepatic iron overload associated     with metabolic syndrome. We hypothesize that this mild iron overload can induce a increased     macrophagic polarization towards inflammatory types, thereby contributing to cardiovascular     risk. Our main objective is to highlight the influence of iron overload on polarization     capacity of monocytes into alternative macrophages (called M2). We therefore compare     phenotypic markers of monocytes/macrophages between subjects with DIOS, metabolic syndrome     without iron overload and lean subjects.   "
93211|NCT02065999|"     This is a multi-centre prospective longitudinal cohort study with the aim of collecting and     storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug     resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs     for hepatitis C therapy.   "
93212|NCT02065986|"     This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP.      To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching     HIV, we need to do a large trial in which half the men do not receive Truvada for one year.     We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are,     whether they would be willing to wait a year before they can take it. The reason it may not     be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could     mean there was more chance of catching HIV and other infections.      As well as finding out if a large trial would be possible, this study will looks at other     factors including:        -  Whether people using PrEP change the number of partners they have sex with        -  Whether people using PrEP change how often they use condoms        -  Whether PrEP leads to higher rates of other sexually transmitted infections (STIs).      This information on changes in sexual activity over time is one of the most important aspects     of the study, because we have never collected this before in the UK. This means we don't know     what happens to people's sexual activity without PrEP! In October 2014 an interim analysis of     the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly protective     against HIV for gay men and other men who have sex with men (MSM) at high risk of infection.     The PROUD Trial Steering Committee announced that participants on the deferred arm of the     study, who had not yet started PrEP, should be offered the opportunity to begin PrEP ahead of     schedule. As a result, we changed the study design and offered all enrolled participants the     opportunity to access PrEP. All study participants will be followed up until study closure in     October 2016   "
93275|NCT02065167|"     The purpose is to assess the safety and feasibility of cellular therapy derived from bone     marrow, to help bone healing in patients with avascular necrosis of the hip.   "
93213|NCT02065973|"     Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety     and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV     infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each     based on a modified 3 + 3 dose-escalation study design. The study will be initiated with     Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose     of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides. All     subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and dose     escalation will be based on safety evaluation for determination of potential dose-limiting     toxicity (DLT).   "
93214|NCT02065960|"     Most women with early breast cancer are treated with breast conserving therapy (BCT),     consisting of breast conserving surgery (surgery to remove the cancer itself) followed by     radiation to the breast. This treatment can take time and is associated with its own side     effect profile. An innovative radiation technique called stereotactic body radiotherapy     (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical     organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been     successfully used for a number of cancers and it is proposed that it could be used to     eradicate breast cancer. This feasibility study will investigate the feasibility and safety     of treatment using SBRT in women with early stage breast cancer.      Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5     treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast     conserving surgery will be performed at 8-12 weeks after radiation to assess response to     treatment. The primary outcome of the study will be feasibility, meaning the ability to     deliver radiation treatment as planned. Secondary outcomes will include treatment related     toxicity and pathological response.      If this study shows that SBRT can be used to treat patients primarily, it will lead to     further evaluation of SBRT for early breast cancer.   "
93243|NCT02065583|"     This study will measure the accuracy of a disposable, non-invasive device for the continuous     monitoring of abdominal sounds, called the AGIS sensor (Acoustic Gastro-Intestinal     Surveillance) in predicting patients' intolerance to feeding (defined as severe nausea,     vomiting, or need to place a nasogastric tube within 4 hours of initiating a standard feeding     protocol) following abdominal surgery. This will be a pragmatic, observational study.   "
93215|NCT02065947|"     The purpose of the study is to investigate if paravertebral block for breast surgery may     improve postoperative analgesia and shorten length of hospital stay. Within a prospective     clinical trial sixty women (ASA I - III) undergoing unilateral mastectomy surgery with     axillary dissection are enrolled. Exclusion criteria are general infection and local     infection at the site of planned puncture, anatomic deformities of the thoracic spine,     coagulation disorders, allergy against local anesthetics or contrast agents, pregnancy or     breast-feeding and BMI ≥ 30 kg/m2.      Patients are randomly assigned to two groups, 30 patients each, by using block of four     method. Group I patients receive paravertebral block at spine level Th 4 via catheter; Group     II patients will have general anesthesia without nitrous oxide.      Paravertebral block (PVB) will be entirely performed by one person (1st author) with the     patient in prone position. In randomly selected patients the catheter localization will be     detected by fluoroscopy after injection of 0.5 ml contrast agent. The catheter positioned at     about 8 cm from skin level, a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with     adrenaline 1:200,000 will be injected sequentially 10 ml each while withdrawing the catheter     2 cm after the first and again 2 cm after the second injection. Then the catheter will be     removed. Low dose intraoperative sedation is provided with IV midazolam 2-3 mg, ketamine 0.5     mg/kg bolus and continuous propofol using target-controlled infusion (TCI) system aiming at     effect site concentration (Ce) of 1 - 1.5 mcg/mL to allow spontaneous breathing. In case     surgical approach is not tolerated, the regional block is graded insufficient, and it is     switched to general anesthesia.      At postoperative care unit (PACU) the pain score using visual rating scale (VRS) from 0 to 10     (worst imaginable pain) is assessed at rest and on movement of the shoulder every 15 minutes     until 60 minutes. Analgesia is provided by IV morphine 0.04 mg/kg boluses with a 15-min     dosing interval to maintain VRS - score < 3. Time to first analgesic demand and 24-hr     analgesics consumption is recorded as well as postoperative nausea and vomiting (PONV).     Complications are recorded including those related to the paravertebral block, such as     Horner's syndrome, epidural spreading, hypotension that is not related to another. Patients     will be checked 6, 12, and 24hr postoperatively for adverse effects, pain scores, and     satisfaction scores.   "
93216|NCT02065934|"     Clinical audit of in-hospital cardiac arrest management by in situ simulation      Objectives: correct latent safety threats, knowledge gap, and crisis resource management     (CRM)      Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation scale.     Exploratory outcomes: non technical skills, validated stress inventory, and questionnaire on     perceptions of the simulation and organisational changes needed.   "
93217|NCT02065921|"     1. Background Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease of          the lungs, which is most commonly caused by smoking. It is characterized as not fully          reversible airflow limitation, chronic cough and dyspnoea. Being the fourth leading          cause of death worldwide, COPD is an important public health challenge and can be          prevented and treated. It is estimated that at least 400,000 individuals in Switzerland          are affected by COPD. This number may increase in the coming years due to increasing          nicotine consumption.           In response to the rising trend, the Global Initiative for Chronic Obstructive Lung          Disease (GOLD) has established new guidelines on the global strategy for diagnosis,          management and prevention of COPD. Systematic diagnosis and stratification are crucial          for effective treatment measures.           As COPD is an irreversible and progressive disease, its treatment aims an early          detection and better management, which leads preventing progression. Disease management          programs have shown that only patients who understand their exacerbation symptoms can          benefit. Moreover, it is a major goal to improve health-related quality of life by          reducing symptoms and decelerating disease progression.           Spirometry is the golden standard for the diagnosis of COPD, to assess the severity of          the obstruction, and as a guide for optimal therapeutic measures.        2. Aim of the study The objective of this project is to establish a COPD cohort database to          allow high quality research on diagnosis, treatment, complication and progression of          COPD on long-term course.           Spirometry should be used consistently for the diagnosis and the monitoring of the          development of the disease. Using collected information such as spirometric data,          disease progression's data and therapeutic measures should help improve the management          and self-management of the patients.        3. Methods 3.1 Study design We are conducting a prospective cohort study, based on COPD          patients from northern and western Switzerland, who are managed under primary care          setting. Patients with mild to very severe COPD (GLOD stages I-IV) are enrolled in the          study.           Currently, 67 General practitioners (GPs) are participating in our Study. Each GP          recruits 1-20 patients with presumed mild to very severe COPD according to criteria of          the Global Initiative for Chronic Obstructive Lung disease [GOLD].           Patients' follow-up-visits occurs at 6-month intervals; their history, symptoms and          examination status is recorded. Data is entered into an online database either by the          physicians or by study team after receiving the collected data questionnaires by          facsimile.           Data collection includes demographic data, physical examination, spirometric parameters,          medical treatment and exacerbation history besides death.           A spirometer (EasyOne™, ndd Medizintechnik AG, Zürich, Switzerland) is used to assess          lung function. All participating physicians were instructed on the usage of the          spirometer and on how to complete spirometry according to the guidelines. For the          assessment of the severity of COPD, we use the spirometric data provided by the GPs. The          COPD severity is interpreted according to criteria of the GOLD committee.           3.2 Patient population Patients with newly diagnosed or existing COPD, who are managed          in primary-care practices.           3.3 Inclusion criteria             -  Tiffenau (FEV17FVC) < 70 without reversibility (Increase in FEV1 after inhalation               of a bronchodilator <200 ml and <12%).             -  Age: > 40 years             -  Both genders             -  Smokers or ex-smokers of at least 20 pack years.             -  Informed consent.           3.4 Archiving and Data Retention All study-related records such as medical records,          informed consent documents, information regarding participants who discontinued, and          other pertinent data will be maintained and therefore retained as long as required by          the applicable Swiss regulatory requirements (10 Years).           3.5 Data security The complete data of the study will be entered anonymously into a          database. The data is password-protected and can only be accessed by investigators and          study members.        4. Publication and authorship 4.1 Publication policy      Authorship credit is based on:        1. Substantial contribution to conception and design, acquisition of data, or analysis and          interpretation of data.        2. Drafting the article or revising it critically for important intellectual content.        3. Final approval of the version to be published. Each author should have participated          sufficiently in the work to take public responsibility for appropriate portions of the          content.   "
93218|NCT02065908|"     In the proposed project the investigators will asses whether changes in expression of     selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of     cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.   "
93219|NCT02065895|"     The purpose of this study is to test the ability of an advanced external Physiologic Insulin     Delivery (ePID) algorithm (a step by step process used to develop a solution to a problem) to     get acceptable meal responses over a range of gain. Gain is defined as how much insulin is     given in response to a change in a patient's glucose level.      This study also examines the effectiveness of the external Physiologic Insulin Delivery     (ePID) closed-loop insulin delivery computer software. The investigators would like to assess     whether fasting target levels can be achieved as the closed-loop gain increases or decreases,     and to evaluate the system's ability to produce an acceptable breakfast meal response.   "
93220|NCT02065882|"     The purpose of the study is to investigate pharmacokinetics, efficacy and safety of BT524 in     patients with congenital fibrinogen deficiency.   "
93221|NCT02065869|"     This study will evaluate pediatric patients with malignant or non-malignant blood cell     disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa     and beta cells that comes from a partially matched family donor. The study will assess     whether immune cells, called T cells, from the family donor, that are specially grown in the     laboratory and given back to the patient along with the stem cell transplant can help the     immune system recover faster after transplant. As a safety measure these T cells have been     programmed with a self-destruct switch so that they can be destroyed if they start to react     against tissues (Graft versus host disease).   "
93222|NCT02065856|"     This trial is an open, national, multi-centre trial. The trial will be initiated in December     2013 and subjects will receive treatment for 6 weeks.      Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with     immediate access to Adverse Events registered in the clinical database. The composition,     procedures and deliverables of the Clinical Safety Group will be detailed in a Safety     Agreement prior to trial start.   "
93226|NCT02065804|"     Groin hernia repair is a common procedure performed in approximately 2,000 patients per one     million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the     patients indicating that a large number of patients each year suffer from debilitating     reduction in health-related quality of life.      This study examines the effect of ultra-sound guided blocks with local anesthesia in the     groin in regard to pain relief and sleep quality.      The hypothesis of the study is that a block will confer significant pain relief to patients     with severe chronic pain following laparoscopical groin hernia repair.   "
93227|NCT02065791|"     The goal of this study is to assess whether canagliflozin has a renal and vascular protective     effect in reducing the progression of renal impairment relative to placebo in participants     with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and     macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled     daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor     blocker (ARB).   "
93228|NCT02065778|"     The purpose of this study was to study the safety and effect of stem cell therapy on the     functional recovery in patients with chronic stroke.   "
93229|NCT02065765|"     The treating physician/investigator contacts Lilly when, based on their medical opinion, a     patient meets the criteria for inclusion in the compassionate use program.   "
93230|NCT02065752|"     The purpose of this study is to assess the bioequivalence of the fixed dose combination (two     components combined in one tablet) of canagliflozin and metformin extended release (XR)     tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin     (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.   "
93233|NCT02065713|"     Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy of     synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has not     been previously studied in randomized controlled trials as a primary endpoint.      In this investigator initiated clinical trial the investigators aim to test the hypothesis     that the combination therapy of golimumab and methotrexate (MTX) will result in a significant     improvement of dactylitis in comparison with MTX monotherapy, in MTX naïve psoriatic     arthritis patients, at week 24. Similarly the efficacy on enthesitis, peripheral and axial     involvement, skin and nail psoriasis, inflammation and damage of the feet and hands assessed     by magnetic resonance imaging (MRI), composite indexes of disease activity, remission,     function and quality of life will be determined.      This is a national multicentre, interventional, double-blinded, placebo-controlled, parallel     design trial. 136 patients with active dactylitis, refractory to at least two systemic     non-steroidal anti-inflammatory drugs (NSAIDs), at optimal dosage, for 3 months will be     included and centrally randomized to golimumab in combination with MTX versus MTX     monotherapy, in a 1:1 ratio. The study duration will be 24 weeks.      The investigators expect the results from this trial will contribute to a better definition     of the treatment algorithm of PsA patients with dactylitis.   "
93234|NCT02065700|"     The primary objective of the study is to evaluate the long-term safety and tolerability of     filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.      Participants will be enrolled in this open-label long-term follow-up study after they have     completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204     (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and     tolerability) when taking filgotinib. During the course of the study, participants will also     be examined for long-term effects of filgotinib administration on disease activity     (efficacy), subjects' disability, fatigue, and quality of life.   "
93235|NCT02065687|"     This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin     hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating     patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better     by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel     and carboplatin is more effective with or without metformin hydrochloride in treating     endometrial cancer.   "
93236|NCT02065674|"     Objective: To ascertain whether homoeopathic medicine ABROMA AUGUSTA has a clinical role in     changing the Glycated Hb Level in Diabetes mellitus Type II.      Abstract:      Background: Type 2 diabetes mellitus (T2DM) is one of the most important epidemic diseases in     the world in this century, and accounts for 90% of cases of diabetes globally. Studies have     suggested that Abroma Augusta plays a role in acute controlling blood glucose level. The aim     of this study was to evaluate the efficacy of Abroma Augusta Ѳ in chronic control through     GlycatedHb (HbA1c %) in Diabetes Mellitus Type 2 (NIDDM) as a pretest post-test study.   "
93237|NCT02065661|"     EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The     devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the     device through a nasogastric (NG) tube and causing a color change in the device. The color     change is then compared to the reference indicator on the device to determine a pH value of     the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the     clinician from being exposed to the aspirate.        1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the          devices by comparing the reading on the 2 devices to a standard clinically approved pH          probe.        2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH          indicator could have been used to determine proper placement of the NG tube when          initially placed.   "
93238|NCT02065648|"     The purpose of the study is to compare non-contrast abdominal MR Angiogram (MRA) syngo NATIVE     sequence performed on a 3T Verio Siemens magnet to a standard contrast-enhanced MRA performed     as part of routine clinical care in patients with normal renal function to determine if the     non-contrast NATIVE sequence is a viable alternative to contrast enhanced MRA in patients     with renal insufficiency. There are no interventions--this is an observational study.   "
93525|NCT02061904|"     Prospective explorative study for the investigation of short-term and medium-term outcomes     regarding bone mineral density changes after revision hip arthroplasty making use of bone     impaction grafting. Outcome measurements will include objective and subjective clinical data,     complications and adverse events, radiographic data measurements recorded at several     postoperative intervals.   "
93239|NCT02065635|"     -  Nitric oxide (NO) is a free radical in gas state which plays an important role in a          variety of processes relevant to respiratory physiology. It represents a means of          detecting airway hyperresponsiveness and appears to have a strong correlation with the          eosinophilic infiltration of the airway. Patients who suffered bronchospasm or          laryngospasm intraoperatively or postoperatively showed higher levels of exhaled NO.        -  Propofol modifies NO production by stimulating the constitutive synthesis of NO and by          inhibiting the inducible production of NO. It seems to exert protective effects on acute          lung injury (ALI) in experimental models and it can possibly reduce exhaled NO. There is          also evidence that some intravenous anesthetic agents can influence chemotaxis of          eosinophils in vitro.        -  Variation of exhaled NO and eosinophils in surgical patients undergoing anesthesia has          not been studied before. Therefore, the aim of this study will be to investigate the          differential impact of maintenance of general anesthesia with propofol versus          maintenance with sevoflurane on exhaled NO and eosinophil blood count.   "
93240|NCT02065622|"     To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in     subjects with moderately to severely active Ulcerative Colitis.   "
93241|NCT02065609|"     The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with     89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.   "
93242|NCT02065596|"     This is a phase I/II study of patients with sickle cell disease. It aims to find out if     people with sickle cell disease can be cured by changing their immune system before they have     blood stem cell transplants. Doctors will give patients a new drug (fludarabine) to see if     this drug changes patients immune system and reduces the patient's cells (host) from     rejecting donor cells (graft) after the patient gets a Hematopoietic (blood) stem cell     transplant.   "
93244|NCT02065570|"     This study will evaluate higher versus standard adalimumab dosing regimens for induction and     maintenance therapy in subjects with moderately to severely active Crohn's Disease and     evidence of mucosal ulceration.   "
93248|NCT02065518|"     The purpose of this project is to compare three treatment regimens for knee injury to the     standard rehabilitation protocol: 1) NMES, 2) graduated strength walking (via a weighted     vest), and 3) NMES combined with graduated strength walking. Each treatment arm will be     supplemented by the standard of care and compared to a group who receive the standard     rehabilitation only.      The Study will compare the effects of NMES, Strength Walking and combined NMES/ Strength     Walking on strength, mobility, symptomatology, and Quality of Life (QOL) in military members     with knee injury to a standard rehabilitation protocol program only. All groups will     participate in standard rehabilitation protocol. The groups will be assessed over 18 weeks to     compare main and interactive effects over time.   "
93249|NCT02065505|"     To evaluate the efficacy of treatment with the Pilates Method in postural alignment and its     correlation with the respiratory capacity of individuals with hemiparesis, with the aid of     biomedical instrumentation, comparing the method performed in soil and therapy pool.   "
93250|NCT02065492|"     Children with thalassemia may have high iron levels after receiving blood transfusions. These     high iron levels can have damaging effects on the body, especially the heart. Conventionally     only chelation therapy was given for prevention of iron buildup in the heart. However,     current research has shown that another drug, amlodipine, also helps to slow down the     deposition of iron in the heart. This study is designed to see if patients receiving     amlodipine along with their regular chelation therapy have a slower rate of iron buildup in     the heart when compared with patients who are receiving chelation only.   "
93251|NCT02065479|"     Numerous studies have shown that pharmacodynamics (PD) response profiles vary among     clopidogrel treated patients and that individuals with reduced response have an increased     risk of recurrent ischemic events. There are multiple factors contributing to clopidogrel     response variability, including genetic variations of the cytochrome P450 (CYP) 2C19 enzyme.     In particular, loss-of-function (LOF) alleles of the CYP2C19 enzyme reduce transformation of     clopidogrel pro-drug into its active metabolite. Thus, patients carrying LOF alleles have     lower levels of clopidogrel's active metabolite as well as diminished platelet inhibition,     which translates into an increased rate of adverse cardiovascular events, particularly in the     setting of percutaneous coronary intervention (PCI). Prasugrel and ticagrelor are novel     generation P2Y12 receptor inhibitors characterized by greater PD potency and reduced ischemic     event rates compared with clopidogrel, and are not affected by CYP2C19 LOF polymorphisms.     However, to date there are limited head-to-head PD comparisons between these two new P2Y12     receptors blockers, and there are no studies assessing on how these agents behave among     CYP2C19 LOF carriers. The aim of the present study is to compare the PD effects of prasugrel     versus ticagrelor in patients undergoing PCI with CYP2C19 LOF alleles using the novel     point-of-care genetic testing Spartan RX-CYP2C19 which permits accurate and rapid     identification of CYP2C19 genetic status.   "
93252|NCT02065466|"     1.1. Primary Objectives      1. To determine if nab-paclitaxel and temozolomide can be combined with full dose of     bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic     malignant melanoma.        -  To define the MTD of the combination (Phase I component).        -  To determine progression free survival (Phase II component). 1.2. Secondary Objectives             1. To separately evaluate the response rate and duration of both the brain and               extra-cranial systemic metastases.             2. To define the toxicity of the regimen.             3. To tabulate the toxicity of the radiotherapy to the brain and compare with known               toxicities of radiotherapy to the brain in melanoma and brain metastases.             4. To use the data generated to plan definitive controlled clinical trials of the               combination.             5. To determine the overall response rate (Phase II component).   "
93323|NCT02064543|"     The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons     living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who     are able to provide informed consent will participate in the assessments.      Outcome variables include selected gait and balance parameters such as cadence, gait-cycle,     stride-length, stride-velocity, turning duration, turning steps, postural sway and     anticipatory postural control. These parameters will be measured by the portable inertial     sensors developed by APDM® and the Zeno/GaitRite.   "
93324|NCT02064530|"     the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to     bupivacaine on TAP block in patients undergoing lower abdominal surgery.   "
93253|NCT02065453|"     Over 600,000 hysterectomies are performed each year nationwide. Over 99% of these are     accomplished laparoscopically in the investigators current surgical practice to allow women a     quicker recovery than a traditional large incision. Disposable laparoscopic devices have been     developed to assist in the completion of hysterectomies. These disposable energy sources are     only used once, but offer an improved safety and energy profile in that they reliably control     bleeding with little damage to surrounding tissue and potentially save time. Reusable energy     instruments can be sterilized and reused for multiple cases. Operating room time is     expensive. The investigators calculate that if 6.7 minutes of time can be saved using the     disposable device, Ligasure (Covidien), versus the reusable Robi bipolar and Storz     Laparoscopic Shears, the time savings could justify the cost of the device.   "
93254|NCT02065440|"     To determine whether ebastine/pseudoephedrine is effective on subacute cough.   "
93255|NCT02065427|"     The purpose of this study is to determine wether a multi-factor intervention involving the     primary caregiver of a dependent patient, with the goal of improving his or her social and     family support and carried out by the professionals of the patient's regular PHCT, will     decrease the burden and increase quality of life for the primary caregiver.   "
93256|NCT02065414|"     Participants will be given special instructions about taking care of their teeth during the     18 hours before they come to the dentist's office for screening/baseline, 1 week, 2 weeks and     4 weeks. At that first visit, they will be examined by a dentist, who will examine their     mouths with a dental instrument to determine whether they qualify to participate in the     trial. Someone who works for the dentist will also take some oral measurements.      Participants who qualify to be in the study will receive a treatment for their gingivitis and     have an equal chance of being assigned to one of three treatment groups. Participants in all     three groups will be given toothpaste that is already available in stores. They will brush     their teeth twice daily in their regular manner. After brushing, participants in one group     will use an experimental mouth rinse that is not available in stores. Another group will be     given a mouth rinse to use that is already available in stores, and the third group will use     a placebo mouth rinse. After they receive their assigned products participants will be     supervised while they brush their teeth and rinse to ensure they understand exactly how to     use the products. Participants will be required to stay at the site 20 minutes after the     first use of product during visit 1 to monitor any potential allergic reaction. All other     brushing and rinsing over the next four weeks will be at home, but participants will be     required to keep a diary to record their brushing and rinsing times twice each day.      Participants will be required to bring their diaries and any left-over toothpaste and mouth     rinse with them for three more scheduled appointments after about 1 week, 2 weeks, and 4     weeks. At those appointments, the dentist will examine their mouths, make sure there are no     safety concerns, and examine again to get the measurements needed. One of the dentist's staff     members will take other measurements as well.      The study will determine the measured effects of the experimental mouth rinse on bleeding as     a result of gingivitis, and compare these results to the mouth rinse that is already     available.   "
93257|NCT02065401|"     The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after     administration of granule and tablet formulations of a deferitazole disodium salt to a     capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in     healthy adult subjects.   "
93258|NCT02065388|"     Purpose:      Warfarin is now the most commonly used oral anticoagulant. This drug has inter-individual     variability due to the genetic polymorphisms in the warfarin metabolizing enzyme, CYP2C9 and     warfarin target, VKORC1. The investigators' team developed a pharmacogenetic dosing algorithm     which can predict patients required warfarin dose, thus could prevent warfarin induced     warfarin adverse events.      Methods:      The investigators recruited patients with indications for warfarin, the genotypes of VKORC1     and CYP2C9 were determined by the hospitals and verified by National Center for Genome     Medicine. The investigators then randomized the patients to one of three arms: 1. Warfarin     dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic     Consortium (IWPC), 2. Algorithm developed by the Taiwan Warfarin Consortium and 3. Standard     of care. The investigators aimed to determine whether using genetic dosing algorithm can lead     to more stable dose and safer use of the drug.   "
93259|NCT02065375|"     This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic     Suspension in the treatment of patients who have inflammation and pain following ocular     surgery.   "
93260|NCT02065362|"     Patients have nasopharyngeal carcinoma (NPC). This study is a gene transfer research study     using special immune cells.      Most patients with NPC show evidence of infection with the virus that causes infectious     mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found     in the cancer cells of almost all patients with advanced stage NPC, suggesting that it may     play a role in causing the disease. The cancer cells infected by EBV are able to hide from     the body's immune system and escape destruction. We want to see if special white blood cells,     called T cells, that have been trained to recognize and kill special parts of EBV infected     cells can survive in patient's blood and affect the tumor.      We already have given EBV-specific cytotoxic T cells to 30 patients with active NPC and have     seen anti-tumor activity in 14 of 30 patients. We are now trying to find out if we can     improve this treatment.      First, we want to give T cells where more of the cells recognize at least two of the four EBV     proteins expressed on NPC cells. We call these cells NPC-specific cytotoxic T cells.      Second, we found that T cells work better if we add a receptor to the T cells called DNR     (Dominant Negative Receptor). DNR makes T cells resistant to TGFbeta, a factor secreted by     cancer cells that helps them escape being killed by the immune system. In this study we will     therefore place the DNR gene into NPC-specific T cells (DNR.NPC-specific T cells).      In other clinical studies using T cells, some investigators found that giving chemotherapy     before the T cell infusion can improve the amount of time the T cells stay in the body and     therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is     called lymphodepletion since the chemotherapy is specifically chosen to decrease the number     of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow     the T cells we infuse to expand and stay longer in their body, and potentially kill cancer     cells more effectively.      The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and     fludarabine. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used     for lymphodepletion in immunotherapy clinical trials.   "
93261|NCT02065349|"     The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock     (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or     postherpetic neuralgia determined by the change in the average daily pain intensity in     patients that initially respond favorably to treatment with ASP8477.   "
93262|NCT02065336|"     The purpose of this study is to determine whether ARC-520 in combination with entecavir is     effective in the treatment of patients with Chronic Hepatitis B Virus (HBV) Infection.   "
93276|NCT02065154|"     The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the     post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The     primary objective is to determine the incidence of grade II-IV acute GVHD following     Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide     (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and     mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination     of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the     safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation.     Disease recurrence and time to recurrence in patients receiving post-transplant     cyclophosphamide compared to historical control without post-transplant cyclophosphamide     (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset,     severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as     observation of Immune Reconstitution over time.   "
93263|NCT02065323|"     This study will evaluate if adding the investigational drug Dovitinib to standard androgen     ablation therapy (ADT) is beneficial in prolonging the time to disease progression in     patients with metastatic prostate cancer who are receiving ADT for the first time.      Dovitinib belongs to the class of drugs known as tyrosine kinase receptor inhibitors.     Tyrosine kinase receptor inhibitors have been shown to have anti-tumor effects and inhibit     new blood vessel formation. New blood vessel development is necessary for the growth and     spread of certain tumors, such as prostate cancer. It is thought that by inhibiting new blood     vessel formation, any existing or new tumors may be unable to grow. Dovitinib targets     existing cancer cells and also works to stop the formation of new blood vessels.      Patients will be randomly assigned to received ADT alone or ADT plus Dovitinib. ADT will be     administered per standard of care. Dovitinib will be taken by mouth once daily for 5     continuous days, followed by 2 days with no Dovitinib. This schedule will repeat and continue     until disease progression or removal from treatment for other reasons. Participants may start     ADT prior to entering the study; however, treatment with Dovitinib must begin no later than     120 days from the start of ADT.      Participants will be asked to donate blood samples for research purposes; this is an optional     part of the study. Research on blood samples will study circulating tumor cells and certain     biomarkers (proteins on cells) to increase the understanding of prostate cancer and explore     if certain biomarkers can help predict how tumors will react to treatment. Samples of     existing tumor tissue will also be examined for research purposes.   "
93264|NCT02065310|"     The purpose of this study is to see if the CEdG assay can produce internally consistent     results and initiate its validation as a biomarker for diabetes in humans.   "
93265|NCT02065297|"     The aim of this open, controlled, multicentre biomedical research study is to identify new     markers specifically associated with Horton's disease. This would make it possible to improve     the diagnosis and management of this disease.      Participation consists in taking one or several blood samples depending on the group     patients/controls.   "
93266|NCT02065284|"     Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic     auditory cues (like a beat) to help improve patients' movements, especially when walking.      The purpose of this study is to compare the effect on walking performance of a home based     walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without     RAS, or to RAS without walking exercise.      A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on     brain activity in patients with Multiple Sclerosis while performing mental imagery of     walking.   "
93282|NCT02065076|"     The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an     effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a     pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two     treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The     change in serum potassium levels will be compared in both treatment groups. The proportion of     subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also     be compared. Finally, side effects will be reported for each treatment arm.   "
93341|NCT02064309|"     The primary objective of this clinical investigation is to investigate the safety of     implantation of the human islet containing device Beta-Air in type 1 diabetic subjects.      The secondary objective of this clinical investigation is to investigate if the     transplantation of macro-encapsulated human islets within the Beta-Air device can provide     improved glycaemic control in type 1 diabetes patients with reduced incidences of     hypoglycaemic episodes.   "
93267|NCT02065271|"     Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and     accounts for a considerable part of health care costs. Herbal supplements are used in many     cultures for the prevention and treatment of many different conditions. Due to lack of     scientific proof, the application in western cultures are minimal. Animal studies have shown     that many constituents of such herbal supplements may have beneficial effects on several     important parameters known to be affected in T2D. Still, no scientific proof in humans is     available. We therefore aim to investigate the effect of 4-week herbal supplementation on     glucose metabolism, lipid metabolism, vascular function and inflammation in subjects with     increased fasting glucose levels or a decreased glucose tolerance.      Objective: The primary objectives are to investigate if 4-week herbal supplementation in     subjects with increased fasting glucose levels or a decreased glucose tolerance has a     positive effect on blood glucose levels and glucose tolerance. The secondary objectives are     to investigate if 4-week herbal supplementation in subjects with increased fasting glucose     levels or a decreased glucose tolerance has a positive effect on triglycerides (TG), total     cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels,     inflammation, adipose tissue and white blood cell gene-expression and AIX both fasted and     during an OGTT test.      Study design: This study is a randomized, double-blind, placebo controlled cross-over trial     in which two different treatments will be evaluated e.g. an intervention with the herbal     mixture and a placebo. Each person will obtain both treatments in random order for four weeks     with a wash out period of four weeks in-between. Fasting blood samples will be collected and     subjects will receive a OGTT, paralleled by a PWA before and after 4-week supplementation.      Furthermore, after 4-week supplement intake we will collect a urine sample and collect an     adipose tissue biopsy. The whole trial will last three months.      Study population: 26 overweight males and females 50-75yrs old with an increased fasting     glucose or with an impaired glucose tolerance.      Intervention: Two intervention periods of 4-weeks in which participants will take three times     a day a supplement of 500mg herbal or placebo.      Main study parameters/endpoints: Fasting blood glucose levels, glucose tolerance as     determined by an oral glucose tolerance test (OGTT), AIX, triglycerides (TG), total     cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, PWA,     adipose tissue an white blood cell gene expression and markers of inflammation .      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Subjects that will participate in the study will invest a total of 16.5 hours.     Blood collection by vena punctures/insertion of the venflon and the collection of an adipose     tissue biopsy can occasionally cause a local hematoma or bruise and some participants may     report pain or discomfort. The herbal supplements contain small amounts St. John's wort,     which may affect the function of liver enzymes. We will therefore monitor liver function     parameters during the supplementation period. Furthermore, subjects are excluded if they use     medication known to be affected by St. John's wort. Participant will donate 284ml of blood,     dispersed over 12 weeks.   "
93277|NCT02065141|"     The aim of the present study is to validate a new method in healthy volunteers and those     diagnosed with COPD and CHF that is able to measure protein digestion and absorption     simultaneously. This method is used to quantify digestion and absorption in patients who are     suspect of impaired digestion and absorption resulting in loss of nutrients.Findings may be     used to develop treatment strategies to improve protein digestion and absorption in these     patient groups.   "
93286|NCT02065024|"     Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps)     has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling     markers (formation and resorption). The present project aims to assess the influence of     technological treatment and genetic variability on the bioavailability and the health effects     of the added components (Ps, b-Cx), in particular to their potential role in prevalent     disorders.In vitro and in vivo studies will be carried out to this effect. In vitro and in     vivo studies (human intervention study) will be performed and cardiovascular, bone turnover     and inflammation markers will be evaluated. Additionally, an in vitro colonic fermentation     model and cell cultures will be used to explore anticarcinogenic effects and potential     cytotoxicity.   "
93268|NCT02065258|"     Background: Asthma is a chronic inflammatory airway disease characterized by reversible     obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and     breathing exercises have been demonstrated to benefit asthmatic patients; however, there is     no evidence comparing the effectiveness of the treatments. Objective: To compare the effects     of aerobic and breathing exercises on clinical control (primary outcome), psychosocial     morbidity and daily life physical activity (secondary outcome) in patients with     moderate-to-severe persistent asthma. In addition, thoracoabdominal kinematics, heart rate     variability and airway and systemic inflammation will be evaluated. The initial hypothesis     will be that both exercises present improved clinical control of asthma. Methods: Forty-eight     asthmatic adults will be randomly divided into 2 groups: aerobic (AG) and breathing exercises     (BG). All treatments will be performed twice a week for 3 months, totalizing 24 sessions of     40 minutes each. Both groups will complete an educational program consisting of 2 classes at     the beginning of the interventions. Before and after interventions, the following parameters     will be quantified: clinical control, health related quality of life, levels of anxiety and     depression, maximal exercise capacity, autonomic nervous imbalance, daily living physical     activity, thoracoabdominal kinematics, inflammatory cells in the sputum, fraction of exhaled     nitric oxide (FENO) and systemic inflammatory cytokines. Asthma symptoms will be quantified     monthly using diaries. Kolmogorov-Smirnov test will be used to analyze the data normality,     and a two-way ANOVA with repeated measures with appropriate post hoc test (Student Newman     Keuls) will be used to compare the inter and intra-groups differences   "
93269|NCT02065245|"     Before initiating the full randomized study, a Pilot Safety Phase will be performed. The     randomized portion of this trial will be conducted after a full review of the safety data     from the Pilot Phase by the Data safety monitoring board.      Following the Pilot Phase of fifteen (15) subjects, up to thirty (30) subjects are scheduled     to undergo infusion and meeting all inclusion/exclusion criteria will be evaluate at     baseline.      An additional twenty (20) subjects will be enrolled in a safety trial for antibiotic free     cells.   "
93270|NCT02065232|"     This is a pain survey study that will compare the level of discomfort experienced by breast     cancer patients after injection of either technetium-labeled sulfur colloid or     technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy     (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original     surgical plan will be asked to participate in this study and be randomized to receive either     technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection,     patients will complete pain questionnaires to measure the amount of discomfort they are     feeling during and after they receive the injection. There will be no change to the patient's     treatment plan other than the addition of pain questionnaires. The investigators' hypothesis     is that patients will feel less discomfort after injection of tilmanocept versus sulfur     colloid.   "
93271|NCT02065219|"     Groin hernia repair is a common procedure performed in approximately 2,000 patients per one     million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the     patients indicating that a large number of patients each year suffer from debilitating     reduction in health-related quality of life.      This study examines the effect of ultra-sound guided blocks with local anesthesia in the     groin in regard to pain relief and sleep quality.      The hypothesis of the study is that a block will confer significant pain relief to patients     with severe chronic pain following open groin hernia repair.   "
93272|NCT02065206|"     While few students may consider a career in research at baseline, receiving information from     peers via online social networks represents a potential way of reaching underserved minority     students.      This study addresses a critical problem in the process to diversify the pipeline of clinical     researchers - how to cultivate baseline interest in research among high achieving youth     before they participate in pipeline programs. We will seek to challenge existing paradigms of     studying effectiveness of interventions to promote entry of minority youth into clinical     research careers through testing a novel social media campaign that aims to increase interest     in research careers among schoolmates of students in a pipeline program. We are testing the     use of of peer-created and inspired videos about career choice as a novel way to develop     messages that have potential to influence teens.      Should this research program be successful, it will yield valuable insights for researchers     and educators who are attempting to train minority students about the importance of involving     youth in creating materials to recruit and retain minorities into pipeline programs and     educational programs targeted towards clinical research.   "
93524|NCT02061917|"     To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess quality     of life measures in smokers randomly switched from their usual brand of cigarette to one of     three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco); or (3) an     ultra-low machine yield tobacco-burning cigarette.   "
93273|NCT02065193|"     The China SCORE study is a prevalence study of Autism Spectrum Conditions (ASC) in 14 regions     in mainland China. It will include the following steps:        1. Large population-based screening This study will be conducted in urban areas but not          rural areas across mainland China. One city of each region will participate, and in          total there will be 14 cities for screening. Within each city, a number of 40 to 60          ordinary primary schools will be randomly selected from the defined region. All the          students who are in 1st to 4th grade will asked to participate in order to form a sample          of approximately 20,000 students.           Screening questionnaires The screening pack includes the Chinese CAST, the AQ-Child, the          AQ-Adult short version (10 items), and risk factors questionnaire. An information sheet          and consent form will be included in the pack as well.        2. Further assessments We expect approximately 5% on the CAST will score positive in          ordinary school population. Thus, for a 20,000 sample, we would expect 900 positives          (90% response rate). All the screen-positives and a random selected 5% from borderline          group will be invited for clinical assessment. The diagnosis of clinical assessment will          be divided into three categories: definite ASC, suspected ASC, and non-ASC. Then all the          children with clinical assessment results as definite ASC and suspected ASC and a          randomly selected 10-20 non-ASC will be invited for research diagnostic assessment using          the ADOS and ADI-R, as well as RPM as IQ test. After that, the consensus diagnosis          between ADOS/ADI-R assessment and the clinical diagnosis will be the final diagnosis.        3. Case identification in special schools All the children in special schools or training          institutes in study region will be asked to fill in the screening pack. The children who          do not attend any ordinary or special schools will be identified according to their          residential ID in the studied regions. All screen-positives in special education will be          assessed using the ADOS and ADI-R. Then those who met the criteria of ASC on ADOS or/and          ADI-R will be assessed by psychiatrists and the clinical diagnosis will be the final          diagnosis.      If we combine the prevalence of ordinary schools and special schools together, we will get an     estimate of the prevalence of ASC in school-population in China. If we combine all the cases     identified from schools and from residential records, we will generate an estimate of the     prevalence of ASC in the general population in mainland China.   "
93274|NCT02065180|"     This randomised controlled trial studies the effect of a commercially available nutritional     supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol     levels.   "
93278|NCT02065128|"     Irritable larynx syndrome (ILS) is a hyperkinetic laryngeal dysfunction that is characterized     by a persistent cough, voice changes, or breathing difficulties, which are often triggered by     an irritant. Diagnosis of ILS is difficult and typically made via a thorough review of the     clinical history and, occasionally, the patient's reaction to an odor-provocation test.     Standard treatment for ILS is behavioural therapy with a speech language pathologist (SLP),     which provides symptom improvement for most patients. However, currently, there are no     objective measures of the upper airway hyper-responsiveness in this condition to assist in     diagnosing and monitoring disease severity.      Since the cough is irritant-based, it is anticipated that patients with ILS will have a     hypersensitivity to the irritant capsaicin. Capsaicin is the active component of chili     peppers and is what makes them hot. The capsaicin cough challenge is a well recognized test     that involves inhaling different concentrations of capsaicin solutions to determine a cough     reflex sensitivity.      The purpose of this research study is to confirm that ILS patients have a hypersensitivity to     capsaicin compared to healthy volunteers. If a hypersensitivity is observed in ILS patients,     the second objective of this study will be to see if behavioural therapy improves the cough     reflex sensitivity in this patient population.   "
93279|NCT02065115|"     This study seeks to determine if cryoanalgesia in the form of ice application could be an     effective analgesic when applied before arterial puncture.   "
93280|NCT02065102|"     Coronary artery stenting has evolved as an effective treatment for angina and involves     stretching up narrowings within the heart arteries using a balloon (coronary angioplasty)     before implanting a small metal scaffold (stent) to splint the artery open. It is imperative     that stents are fully expanded when they are deployed. If not, then patients are exposed to     the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent     renarrowing (restenosis). One fifth of patients experiencing stent thrombosis will die and     70% will suffer a heart attack. Restenosis is associated with recurrent angina and heart     attacks.      Arguably, visualising stents and ensuring adequate stent expansion is most challenging in     patients with extensive hardening, or calcification, of the heart arteries. Optical coherence     tomography is a novel technique that utilises near-infrared light to look inside small blood     vessels in fine detail. It is 10 times more powerful than the best existing technique,     intravascular ultrasound.      The purpose of this study is to compare the utility of optical coherence tomography with     intravascular ultrasound in patients with heavily calcified heart arteries undergoing     rotational atherectomy and coronary stent insertion. It is hoped that the results of this     pilot study will provide proof-of-principle and justification for a larger clinical trial to     formally assess the role of optical coherence tomography to guide coronary angioplasty and     stenting in patients with heavily calcified coronary arteries.   "
93281|NCT02065089|"     We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma';     to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps     can be used to improve patient education.   "
93342|NCT02064296|"     The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on     patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is     effective for FM because it functions as a desensitization therapy, which when applied     repeatedly over multiple treatment sessions, gradually habituates the nervous system to     continuing pain and sensory signaling.   "
93283|NCT02065063|"     This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to     determine the recommended dose and schedule for the orally administered MEK inhibitor     trametinib, given together with the CDK4/6 inhibitorpalbociclib in subjects with solid     tumors. Multiple dose levels of each inhibitor will be tested to determine the recommended     dose and schedule. Part 2 will evaluate the effect of the combination on tumor biomarkers     safety, and anti-cancer activity in subjects with cutaneous melanoma that do not have a     change at BRAFV600. Approximately 100-200 subjects will be enrolled. All subjects will     receive trametinib and/or palbociclib until disease progression, death, consent withdrawal or     unacceptable adverse event (AE).   "
93284|NCT02065050|"     This study is being performed to evaluate whether a comprehensive discharge planning and     close follow up for one year can improve clinical outcomes and cut costs of care for patients     with poorly controlled diabetes. The study takes a high risk approach and is focused on     patients admitted to hospital for elective surgery with HbA1c >8%. Secondary goals include     improving teamwork and communication for clinicians within the team and teaching nurse     practitioners and physicians-in-training how to work effectively within interdisciplinary     teams. Investigators anticipate that the results of this project may lead to the following     benefits: 1) improved health outcomes for surgical patients with diabetes, 2) improved     strategies for better communication within interdisciplinary health care teams, and 3)     decreased health care costs.   "
93285|NCT02065037|"     Colorectal cancer is the second most common cancer in the world and the second leading cause     of cancer-related mortality. Colorectal cancers arise from precursor adenomatous polyps in a     well characterized adenoma to carcinoma progression. The removal of such precursor lesions     reduces colorectal cancer mortality between 30 to 50%. Colonoscopy is used for detection of     neoplastic polyps but significant miss rates of such lesions are reported. Methods to reduce     spasm of the colon have been investigated to increase adenoma detection rates including the     use of warm water irrigation and hyoscine butyl bromide. Carbon dioxide warmed to body     temperature is postulated to have spasmolytic effects. Administration of warmed carbon     dioxide during colonoscopy may improve polyp detection.      Objective: In this study, colonoscopy using warmed carbon dioxide insufflation will be     compared to standard room temperature air insufflation to see if there is a greater detection     of polyps per patient.      Methods: Patients undergoing colonoscopy for screening and surveillance indications will be     included and randomized to receive either room temperature room air or warmed carbon dioxide     (37 degrees Celsius). Endoscopists and patients will be blinded to the intervention. Data on     indication, preparation, sedation, withdrawal time will be recorded. Polyp detection rate     will be the primary outcome. Secondary outcomes will include adenoma detection rate and     advanced lesion detection rates.   "
93287|NCT02065011|"     Primary Objective:      To evaluate the long-term safety and tolerability of UshStat® in patients with Usher syndrome     type 1B      Secondary Objective:      To assess long-term safety and biological activity of UshStat®   "
93288|NCT02064998|"     The purpose of this study is to evaluate the efficacy of three mobile phone applications,     Promillekoll, PartyPlanner and TeleCoach among university student union members with     problematic drinking. Two trials are conducted, one a three-armed randomized controlled     study, and the second a two-armed randomized control study. Outcomes are measured in terms of     changes in problematic alcohol use at follow up 6,12 and 18 weeks after baseline data     gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of     alcohol consumption and give feedback of estimated blood alcohol concentration levels.     PartyPlanner also allows for planning an alcohol consumption event in advance and for later     comparison of the plan with actual consumption. Study 1 compares these two apps with a     control group. In Study 2, participants reporting alcohol consumption above the weekly     recommended level are redirected to randomized assignment to an in-depth app, TeleCoach,     which offers different exercises for reducing alcohol use. After 6 weeks the controls are     offered the TeleCoach intervention for 6 weeks, and the first intervention group loses app     access. In both studies, followup occurs 6, 12 and 18 weeks after baseline registration.      Hypotheses:      Study 1: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce     their alcohol use to a larger extent than the control group at follow-up compared to the     baseline level. 2. The planning function in PartyPlanner will be associated with an increased     decrease in alcohol consumption compared to only real-time use for Promillekoll.      Study 2: The proportion of participants with risky use above recommended levels will decline     faster in the group that receives the intervention first, in comparison to controls.   "
93289|NCT02064985|"     open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety     study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese     patients with stable coronary heart disease   "
93300|NCT02064842|"     The purpose of the study is to investigate the safety, tolerability, and pharmacokinetics of     TMC647055 in combination with ritonavir (Part 1); potential pharmacokinetic drug-drug     interactions between TMC435 and the combination of TMC647055 with ritonavir; and to evaluate     the short-term safety and tolerability when TMC435, TMC647055 and Ritonavir are     co-administered (Part 2) in healthy Japanese participants.   "
93301|NCT02064829|"     The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in     female patients with metastatic or locally recurrent breast cancer. In addition, the study     will compare the safety and tolerance of IG-001 and nab-paclitaxel during the bioequivalence     2-period crossover portion of the study. The study will also evaluate the long-term safety of     IG-001 over repeated cycles, up to 4 additional cycles of administration.   "
93290|NCT02064972|"     In consideration of the fact that the vascular endothelium has been shown to be a target of     GvHD in early stage and that the count of CEC may represent a marker of endothelial damage,     we want to evaluate the changes in CEC counts of patients affected by hematological disorders     undergoing allo-HSCT, as a function of endothelial damage. We will enroll 50 patients     affected by hematologic disorders undergoing allo-HSCT. Peripheral blood will be drawn before     (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant), upon     confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of GVHD     (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD). All patients will     also be checked for CEC at day + 28. CEC enumeration will be performed by using the     CellSearch® System and a flowcytometry procedure.      Through the conduct of this study, we expect to confirm our preliminary results on a larger     series of patients, and to evaluate the predictive role of CEC on the occurrence of GvHD and     prognostic response to treatment of GvHD. The possibility of early identification of patients     who do not respond to traditional treatments of GvHD, and for this reason at a higher risk of     morbidity and mortality, may allow greater individualization of the therapeutic program, for     example with the introduction as early as possible of alternative treatments. In addition,     the identification of patients at higher risk of non-responsiveness to steroid treatment,     would allow, through a closer monitoring, the early introduction of additional treatment     before the development of resistance/refractoriness to treatment of GvHD.      The present study takes the form of a prospective study. The primary endpoint is the     identification and enumeration of CECs in peripheral blood of patients with hematological     disorder undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint is     to define the prognostic and predictive value of the changes of CEC counts on the diagnosis     of GvHD and response to treatment.   "
93291|NCT02064959|"     This randomized, prospective trial will study the effect of very early cooling in patients     undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura     followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters     (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain     normothermia.      The primary objective is to determine if rapid induction of hypothermia prior to emergent     craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow     Outcome Scale-Extended (GOSE) at 6 months.   "
93292|NCT02064946|"     The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation     regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate     cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled     clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60     and older, beginning ADT, and scheduled to receive at least 6 months more of ADT.     Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin     D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin     and calcium supplement.   "
93293|NCT02064933|"     Wiskott - Aldrich syndrome (WAS) is a rare serious medical condition that causes problems     both with the immune system and with easy bruising and bleeding. The immune abnormalities     cause patients with WAS to be very susceptible to infections. Depending on the specific type     of primary immune deficiency diseases, there are effective treatments, including antibiotics,     cellular therapy and gene therapy, but studies of large numbers of patients are needed to     determine the full range of causes, natural history, or the best methods of treatment for     long term success.      This multicenter study combines retrospective, prospective and cross-sectional analyses of     the transplant experiences for patients with WAS who have already received HCT since 1990, or     who will undergo Hematopoietic cell transplant (HCT) during the study period. The     retrospective and prospective portions of the study will address the impact of a number of     pre and post-transplant factors on post-transplant disease correction and ultimate benefit     from HCT and the cross-sectional portion of the study will assess the benefit of HCT 2 years     post-HCT in consenting surviving patients.   "
93294|NCT02064920|"     This study aims to determine whether the Cogstate testing battery can detect improvements in     cognitive function in participants with mild AD. The primary hypothesis is that for one of     the Cogstate battery tests, One Card Learning (OCL), the standard deviation associated with     the change from baseline in OCL measurements after 12 weeks of donepezil and placebo     treatments is =<0.1   "
93296|NCT02064894|"     Pain management for children presenting to the emergency department (ED) with an injured limb     is often under-treated, even though it is known that broken arms and legs cause moderate to     severe pain. Further, children are less likely to receive appropriate pain medicine than     adults with similar injuries. This study aims to improve the pain treatment of children who     present to the ED with a suspected fracture, or broken bone or severe sprain. The     investigators will compare the use of 3 different possible medication combinations (ibuprofen     alone, oral morphine alone, or combined ibuprofen and oral morphine) to determine which     combination is the best at treating children's pain. The investigators also plan to verify     the safety of using these different drugs to treat children's pain.      The investigators strongly believe that children's pain should be optimally treated in the     ED. Adequately relieving children's pain is crucial, as inadequate pain treatment can have     both short and longterm effects on the child. It also generates unnecessary stress for both     the child and their caregivers/parents. Given this knowledge, the investigators feel that     their study has the potential to impact care provided in EDs, and improve pain management     safely, for children.   "
93297|NCT02064881|"     The aim of this study is to evaluate the effect of metformin glycinate vs metformin     hydrochloride on postprandial lipemia. 72 patients will be included, they will be randomized     and assigned into one of the two treatment groups: metformin glycinate 1240 mg BID or     metformin hydrochloride 1000 mg BID (36 patients per group). The patients will be followed     for 4 months.      Blood count, blood chemistry, liver profile, lipid profile, HbA1c, apolipoprotein B, oxidized     LDL, fibroblast growth factor 21, leptin, adiponectin, C-reactive protein, free fatty acids,     fibrinogen, Goodpasture Binding Protein (GPBP) and antioxidant activity of plasma will be     measured at baseline and 4 months.      Additionally, after a structured meal, the following parameters will be measured: glucose,     insulin, triglycerides, apolipoprotein B and oxidized LDL. (baseline and 4 months).     Throughout the study adverse events will be documented.   "
93298|NCT02064868|"     This is a multinational, multicenter, randomized, open-label study to confirm and expand the     efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30     micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for     Acute Heart Failure (AHF).   "
93299|NCT02064855|"     The purpose of this study is to evaluate fusion status and patient outcomes observed from use     of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the     literature reported outcomes of spinal fusion using autograft with posterior stabilization.   "
93303|NCT02064803|"     The incidence of unresectable and obstructive gastric cancer patients ranges in the     literature from 5 to 30 % . In such cases, gastro-entero anastomosis is traditionally     performed and can improve the quality of life by relieving the symptoms of impaired oral     intake without having a high surgical risk. Unfortunately, up to 25% of these patients may     develop impaired gastric emptying syndrome. Gastric partitioning was originally described by     Devine in 1925 as a method of antral exclusion and complete division of the stomach     accompanied by a gastro-entero anastomosis in the proximal gastric pouch for the management     of difficult duodenal ulcers. This procedure has been modified along the years and was     adopted for the palliative treatment of gastric cancer. The advantages of the partitioning     includes: better gastric emptying, avoidance of direct tumor invasion of the gastro-entero     anastomosis, less contact between the ingested food and the tumor with less blood lost and     improved survival. Retrospective not randomized studies have been published demonstrating the     effectiveness of the procedure.   "
93304|NCT02064790|"     Although some studies show improvement of pain and associated effects of pain with off-label     use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published     evidence so far. We propose to complete a year-long prospective, observational study as a     pilot to recruit 400 patients within the year and follow their pain level, function, and QOL     measures for 16 weeks to determine whether it is feasible to continue studying this group in     the future. We expect that pain, function, and quality of life will be improved in the group     of patients who are given neuropathic agents as an adjunct to other conservative treatments     compared to the expected 65% of patients with similar symptoms who are treated conservatively     without neuropathic agents. We do not expect a statistically significant difference between     the two neuropathic agents.      Since these drugs are currently used off-label, there is limited empirical evidence regarding     which agent is more efficacious compared to the other, and since their use in treating     radicular pain is based mostly on anecdotal evidence so far, prescription of one or the other     of these agents has been based on likely compliance (medication needed twice a day, three     times a day) or whether or not the patients' insurance will pay for one or the other. This     study will be a first step to better assist practitioners in counselling their patients on     use of these medications in radiculopathy, examining rates of discontinuation due to side     effects and what effects these medications have on perceived pain, function and quality of     life.   "
93305|NCT02064777|"     Our first aim is thus to investigate, retrospectively first and then prospectively, in de     novo pediatric (living donor) liver recipients, the tacrolimus in vivo and in vitro     metabolism and its variability with focus on pharmacokinetics, pharmacodynamics, and     pharmacogenomics and its evolution according to the age and transplant delay. Our second aim     is then to find better tacrolimus exposure markers for therapeutic drug monitoring (TDM) such     as Area Under the time-concentration Curve (AUC) or intralymphocytic (PBMCs) tacrolimus     concentration and a way to model and predict it without invasive tests in pediatric patients.      The final objective should be then to implement these findings in a more individualized and     comprehensive immunosuppression protocol and monitoring in order to maintain adequate and     well-balanced immunosuppression (preventing graft rejection while avoiding acute and     long-term side effects). This is particularly important for a pediatric population exposed     throughout their life to immunosuppressants.   "
93306|NCT02064764|"     The purpose of this clinical study is to evaluate the feasibility of performing both renal     nerve denervation and pulmonary vein isolation on the same patient with the intent of     characterizing both safety and effectiveness in a paroxysmal and persistent atrial     fibrillation population with hypertension. To assess safety, the study will measure the     occurrence of a composite safety endpoint and, to assess effectiveness, the study will     measure freedom of chronic treatment failure through a minimum of six months of follow-up.   "
93311|NCT02064699|"     Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high     morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R +     develop CMV. The number of available antiviral drugs is reduced and noticeable side effects     (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of     reduced doses that promote non-response to treatment and the emergence of resistance. In case     of neutropenia, there are more an increased risk of secondary rejection due to the reduction     of immunosuppressive treatment rendered necessary by the haematological reached.      Rational use of these molecules is necessary with essential today as the optimal duration of     prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection     reported in.   "
93339|NCT02064335|"     In this project the investigators like to develop a methodology to stimulate more physical     activity in inactive diabetic persons by an adapted physical activity program. An     individually oriented and medically adapted exercise plan will be set up. Participants will     be stimulated to be physically active in the long term, even when the coaching has been     finished.      In a randomized controlled trial the health effects of the coaching are studied in the short     and long term. This trial, in addition to a process evaluation by all stakeholders, gives     more information about the implementation of the project in Flanders.   "
93340|NCT02064322|"     The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for     fusion and pain reduction of the SI joint.   "
93312|NCT02064686|"     The goals : to develop and computerize equipment for measuring ITAE , compare the results     with TAEP Itae study the possible relationship between different markers of inflammation:     sputum eosinophils , FeNO , the ITAE and TAEP and see the influence spirometry or a     bronchodilator in measuring the ITAE .      It has designed a line of work studying the following aspects :      1. Comparison with TAEP ITAE in a group of healthy and stable asthmatics 60 patients , 30     asthma and 30 volunteers .      Two . Study of the relationship between the number of eosinophils in sputum, FeNO , the ITAE     and TAEP , 30 patients randomly FeNO , the ITAE and TAEP be measured.      Three . ITAE measurement before and after the spirometry test , 20 patients , in stable phase     will be measured before and after the ITAE spirometry .      April . ITAE baseline measurement and after administration of 400 micrograms of salbutamol ,     20 patients diagnosed with asthma , phase stable , they measure the ITAE before and fifteen     minutes after administration of salbutamol .      May . Measurement in patients Itae a bronchial provocation test with methacholine was     performed , 20 patients were measured and baseline Itae after administration of methacholine     .      6. Measuring Itae in patients during an asthma exacerbation and stable phase , 20 patients     during an exacerbation , the ITAE be measured. Already in clinically stable measurement is     repeated.   "
93313|NCT02064673|"     This is a prospective study to determine if the adjuvant use of Curcumin improves     recurrence-free survival.   "
93314|NCT02064660|"     Myopia is widely one of the three commonly detected refractive errors. Myopia is usually     managed by correction through glasses or contact lenses. Other alternative available include     surgery, drugs and acupuncture. There are various therapeutic approaches and different points     can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure     body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely     unknown. Furthermore, little information exists regarding the effects and safety of     acupuncture for degenerative myopia in children.      The investigators aimed to assess the overall effectiveness, safety of periocular acupressure     for children with myopia      The hypotheses of this study are as follows:      Periocular acupressure is effective for myopia progression delay.      The study aims to include 56 participants.   "
93315|NCT02064647|"     Continuous glucose monitoring (CGM) provides up to 288 blood glucose levels per day, updated     every 5 minutes and displayed in real-time on the insulin pump, which can be used to enhance     delivery of insulin through pump therapy. In addition this real-time CGM data includes trend     arrows which indicate when the blood glucose is rapidly falling or rising thus enabling the     pump user to make immediate adjustments in insulin delivery to prevent subsequent low or high     blood sugars. The trend arrows are displayed when the blood glucose is rapidly falling or     rising. For example, if the glucose is increasing by 1-2 mmol/L over 20 minutes, a single     upward arrow alerts the pump wearer, who can then decide to give a bolus of insulin or     increase the meal bolus. Should the glucose level be increasing at a rate greater than     2mmol/L over 20 minutes, 2 upward arrows are displayed and the user could decide to give a     larger bolus. The purpose of the bolus adjustment is to add insulin for the predicted rise in     glucose to prevent or reduce subsequent hyperglycemia. Similarly, a decrease in the insulin     bolus is advised if glucose levels are falling as evidenced by one or two downward arrows.      However, effective strategies for adjusting insulin boluses based on CGM trend arrows are     lacking. The JDRF CGM Study Group recommended that boluses be adjusted based on trend arrows     using a standard 10-20% increase/decrease of the total original recommended bolus dose (10%     for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose     calculated by the pump calculator (i.e. Bolus Wizard). However, the original recommended     bolus dose is dependent on the amount of food to be consumed (grams of carbohydrate) and the     current blood glucose (if above or below target range), as well as the amount of active     insulin, and therefore increasing or decreasing the total recommended bolus by 10-20% may     overcompensate for the trend arrows and result in postprandial hypoglycemia. Attempts to use     the10/20% formula within CHEO's large pediatric pump/CGM population resulted in low     acceptance and adherence by CGM users.      The CGM TIME Trial Study Group develop an innovative tool for adjusting boluses for CGM trend     arrows based on the patient's own insulin sensitivity factor (ISF). The Trend Arrow     Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/-     (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Use of the Trend Arrow Adjustment Tool     within the CGM TIME Trial appears to lead to more appropriate adjustment in bolus dosing, and     more effective prevention of subsequent hyper- and hypoglycemia. Furthermore, this tool     appears to have excellent uptake amongst the TIME Trial participants, with observations that     there is continued usage of the tool throughout the 12 month study, and greater satisfaction     with this component of CGM. However, the tool has not been systematically evaluated.      The proposed study will evaluate the Trend Arrow Adjustment Tool, to determine its     effectiveness in reducing postprandial hyper- and hypoglycemia, as well as parent,     child/youth satisfaction, and ease of use of the tool based on self-report measures.     Comparison will be made with the 10/20% bolus adjustment & also to no adjustments to meal     boluses (i.e. ignoring CGM trend arrows). Should use of the Trend Arrow Adjustment Tool lead     to more time spent within the target glucose range, this will have immediate clinical benefit     for patients, including improved quality of life, and potentially a reduction in HbA1c and     prevention of long-term complications.   "
93316|NCT02064634|"     This study investigates how gastrointestinal toxicity affects discontinuation of medication     given to patients with osteoarthritis in routine clinical practice.   "
93317|NCT02064621|"     The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of     Candesartan between free combination of Candesartan and Amlodipine and Candesartan     monotherapy.   "
93318|NCT02064608|"     Patients with localised prostate cancer can be treated by radical prostatectomy (prostate     gland removal surgery) or radiotherapy. Around 15% of men with prostate cancer are diagnosed     with high risk disease meaning they are more likely to suffer treatment failure, disease     progression and mortality. To date little progress has been made towards identifying     effective treatment strategies that might delay or prevent disease recurrence in this patient     population. Better identification of patients at high risk of relapse and improvements in     therapy are therefore research priorities.      A protein named Mammalian Target of Rapamycin (mTOR) is known to play an important role in     the development of prostate cancer. mTOR forms two protein complexes (mTORC1 and mTORC2) and     sends signals helping cancer cells to grow while controlling their energy use. Blocking the     function of mTOR, with an inhibitor such as AZD2014, might shut down the supply of energy     supply to tumour cells leading to reduced cell growth and potentially slowing the progression     of the disease.      The purpose of this study is to investigate the molecular pharmacology of AZD2014 treatment     given to patients with prostate cancer prior to radical prostatectomy. The feasibility,     safety and tolerability of a short course of AZD2014 will also be assessed.   "
93319|NCT02064595|"     The objective of this research is to prospectively evaluate a group of patients with shaft     compound fracture of the tibia, treated with a biplanar external fixator or locked     intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and     postoperative complications.   "
93320|NCT02064582|"     The study is being done to find out whether combining two FDA approved drugs along with     radiation therapy for the treatment of high risk localized prostate cancer is safe and well     tolerated.   "
93321|NCT02064569|"     The purpose of this study is to evaluate the safety and tolerability profile of ascending     doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.   "
93322|NCT02064556|"     The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of     Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.   "
93325|NCT02064517|"     Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium)     allows to obtain a better forecast of preservation of the tooth without complication than the     conventional technique with the creation of an apicale barrier in the MTA in 24 months.   "
93326|NCT02064504|"     GSK961081 is a novel bifunctional molecule that combines muscarinic antagonism and     beta2-agonism in a single molecule and is in development for the treatment of chronic     obstructive pulmonary disease (COPD). This is a randomised, open-label, six-way crossover,     single dose study. This study evaluates the drug delivery and systemic pharmacokinetics of     GSK961081 following concurrent administration of GSK961081 and fluticasone furoate via dry     powder inhaler (DPI) in comparison to GSK961081 DISKUS. There will be six treatment periods     and 7 days washout period in the study. Subjects will attend the unit in the morning for     dosing and will be resident until 12 hours post administration. All subjects will receive six     treatments.   "
93545|NCT02061644|"     We aim to investigate the effect of spinal anesthesia on intraocular pressure.   "
93329|NCT02064465|"     This is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of     lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed     tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal     numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or     lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be     collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours     post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse     events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days     post-dose.   "
93330|NCT02064452|"     This study will experimentally evaluate an internet-based version of the Triple P Positive     Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in     an interactive, video-enriched, and personalized format with 3-levels of flexible dosage, and     will compare it against usual community services. Thirty pediatric clinics involving 100     practitioners in 9 counties across western Washington will be recruited and randomized to     receive (a) access for their patients to the Triple P Online System and training in how to     effectively promote TPOS and advise parents on their children's behavior problems or (b)     Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate     referral for services in the community.   "
93331|NCT02064439|"     This is a multicenter, randomized, double-blind, event-driven, superiority study for     efficacy.      Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who     completed 6 or 12 months of treatment of anticoagulation are eligible for this trial   "
93332|NCT02064426|"     Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934     versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response     and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once     daily.   "
93333|NCT02064413|"     To evaluate the safety and successful placement rate of Essure Model ESS310 device and any     factors that may influence the successful placement rate of this device.   "
93334|NCT02064400|"     Little is currently known as to the predictive value of ultrasound in guiding the decision to     taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that     patients' views and opinions regarding their medications may have upon this. In this study,     patients with stable rheumatoid arthritis will undergo a simple examination of their joints     to look for any swelling or tenderness followed by an ultrasound scan to look for joint     inflammation. Half of the patients will also complete an interview to assess their views and     opinions of arthritis drug treatment. The study will be completed in a single patient visit -     no invasive tests will be performed, and no changes to treatment will be made.      This study is being conducted as part of a Masters degree from Newcastle University. The     results of this study will be used to inform the feasibility of inclusion of ultrasound     assessment within the design of a future PhD study to investigate potential markers of     remission in patients with rheumatoid arthritis.   "
93335|NCT02064387|"     This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the     therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that     express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely     administered to subjects with MM and with BCMA positive malignancies at doses where target     engagement can be demonstrated. This study will determine if adequate target engagement of     BCMA receptors translates into clinical benefit for subjects with MM and BCMA positive     lymphomas. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2     expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study     will enroll a total of approximately 80-95 subjects with relapsed/refractory MM or     BCMA-expressing hematologic malignancies. The maximum dose to be administered in this trial     will not exceed 5 milligram/kilogram(mg/kg).   "
93336|NCT02064374|"     This study will be a phase 1, open label, parallel group, three period crossover study to     evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of metformin     and on the safety and tolerability of dolutegravir and metformin. Subjects will have a     screening visit within 30 days prior to the first dose of study drug, three treatment     periods, and a follow up visit 7-14 days after the last dose of study drug. Eligible subjects     will be assigned to one of the two treatment cohorts. Subjects will receive metformin 500     milligram (mg) after every 12 hours (q12h) for 5 days in Period 1; metformin 500 mg q12h plus     dolutegravir 50 mg after every 24 hours (q24h) (Cohort 1) or 50 mg q12h (Cohort 2) for 7 days     in Period 2; and metformin 500 mg q12h for 10 days in Period 3. There will be no washout     periods between treatments. All doses of study drug will be taken following a meal. Safety     evaluations will be collected during each period. Serial pharmacokinetic (PK) samples will be     collected for metformin on the last day of each period and for dolutegravir on the last day     of Period 2.   "
93337|NCT02064361|"     The purpose of this study is to determine the impact of high intensity,anaerobic exercise, in     the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and     subtype of circulating microparticles, complete blood counts, and the quantification of     venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.   "
93338|NCT02064348|"     This trial is conducted in Europe. The aim of the trial is to evaluate the effect of     semaglutide on cardiac repolarisation in healthy subjects.   "
98342|NCT01998945|"     We will compare two programs that are designed to help older adults who have had fall     injuries manage anxiety and improve their level of functioning. We expect that both programs     will provide some benefit, but that one will promote better management.   "
93345|NCT02064257|"     A research project funded by the Australian Childhood Foundation (ACF) will be conducted in     Australian facilities of the ACF to evaluate the effectiveness of the Listening Project     Protocol (LPP) in children with a trauma history. The LPP is designed as a neural exercise     to reduce auditory hypersensitivities, to improve auditory processing of speech, and to     improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural     regulation of the middle ear structures to rehabilitate and to normalize the acoustic     transfer function of the middle ear structures. The current study is being conducted to     evaluate efficacy and feasibility of the LPP and will use objective measures to evaluate     changes in acoustic transfer function of the middle ears structures, auditory processing     skills, physiological state regulation, and sensory symptoms.   "
93346|NCT02064244|"     Bedside ultrasonographic assessment of IVC size and IVC collapsibility index can be used to     guide the management of patients with acute kidney injury with and without volume overload in     the intensive care unit   "
93347|NCT02064231|"     To assess the functionality and safety of the test products and also assess the products     ability to collect stool without interfering with the stoma.   "
93348|NCT02064218|"     First of all to evaluate the relationship between non-conventional biomarkers and essential     hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood     pressure control and non-conventional biomarkers in naive hypertensive patients   "
93349|NCT02064205|"     Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency     of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that     regulate satiety may play a role in weight management. Suppression of appetite may reduce     energy intake, which in return may lead to body weight reduction. This study aims to verify     the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight     and overweight women.   "
93350|NCT02064192|"     The EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic     Implantable Cardioverter Defibrillators (EU-CERT-ICD) is a modular research project to study     the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and     meta-analyses of existing evidence on the subject.   "
93351|NCT02064179|"     The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects     is routine in intensive care units around the country and world in children who have     undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after     repair. Most common protocols recommend heparin infusions after surgery with transition to     oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart     surgery requiring long-term antiplatelet therapy include those undergoing shunt placement for     single-ventricle palliation or establishment of pulmonary blood flow, valve replacements, or     coronary artery manipulation. Post-operative thrombosis after congenital heart surgery is     rare, but thrombosis can result in death. The routine use of aspirin in these patients is     intended to prevent the potentially catastrophic consequences of thrombosis. However, there     is no routine clinical assessment of the platelet inhibitory effect of aspirin; nor have     there been any prospective studies to assess the effectiveness of aspirin's antiplatelet     effect in children after congenital heart surgery. No data exists to suggest that the first     dose of aspirin transition from heparin infusion is either sufficient or insufficient in its     antiplatelet effect.      In this study, the investigators will evaluate the effectiveness of the first aspirin dose in     its antiplatelet effects after surgery for congenital heart disease. Degree of antiplatelet     effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping study     analysis. Thromboelastography is a clinical laboratory method of assessing whole blood     hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most     commonly used in patients at risk for bleeding or thrombosis and also to monitor antiplatelet     therapies (such as aspirin).      The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion     after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and     TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help     support the current practice of empiric aspirin therapy to prevent post-operative thrombosis     in children after congenital heart surgery.   "
93352|NCT02064166|"     Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative     disorders characterized by abnormal accumulation of α-synuclein. There is no effective     treatment that can slow down the disease progression and both disorders are associated with     severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and     memory in healthy and cognitively impaired non-diabetic adults.      The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322)     has shown that a single 40 international units dose of intranasal insulin improves     visuospatial memory in diabetes and control subjects.      This proposal includes randomized, double blinded, placebo-controlled trial of intranasal     insulin (40 international units daily) in treatment of PD and MSA.      The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the     study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of     cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of     the cognitive scale ratings.   "
93353|NCT02064153|"     Hemodialysis (HD) is widely used treatment for end stage renal diseases (ESRD) patients. The     chief aims of HD are solute and fluid removal. Decades of practice have improved HD care, but     more can be done to improve morbidity and mortality. Enhancing toxin removal is an important     consideration for improved patient outcomes. Also, decreasing the incidence of intra-dialytic     hypotensive (IDH) episodes (dominant in Singapore patient cohort) can significantly reduce     associated morbidities and mortality. A simple maneuver for clinicians is the dialysate     temperature. Literature suggests that a lower dialysate temperature (35ºC) results in reduced     hypotensive episodes by vasoconstriction. Conversely, higher dialysate temperature resulting     in higher blood temperature decreases the peripheral resistance, leading to increased toxin     removal, but may cause IDH episodes partly due to vasodilation. Optimal manipulation of the     dialysate temperature is therefore primary handles to obtain the improved patient outcomes.     In this study, the effect of dialysate temperature (cool vs. warm dialysate) on toxin removal     will be studied. In both the interventions, outcome measure will be patient hemodynamic     response and amount of toxins removed. The spent dialysate will be collected to study the     quantum of toxin removed.   "
93364|NCT02064010|"     This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects     with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a     randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing     levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of     90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and     safety profiles of SNC-102 in the target population.   "
93365|NCT02063997|"     The purpose of this study is to determine whether arhalofenate is effective in preventing     flares and reducing serum uric acid in gout patients.   "
93643|NCT02060370|"     The goal of this clinical research study is to learn more about the safety of giving     sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which     they receive no drug. Researchers want to learn more about the side effects of the drug and     the effects of a different dosing schedule.   "
93354|NCT02064140|"     Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary     infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development     of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high     (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV     is the conventional ventilation strategy to ensure lung protective ventilation (low tidal     volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the     development of respiratory muscle atrophy (due to disuse) and the need for high dose     sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and     respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes     and prolonged MV.      Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV     decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics,     and lowers consumption of sedatives. However potential disadvantages of supported ventilation     include generation of too high tidal volumes, especially in patients with high respiratory     drive. A previous study in healthy subjects has shown that titration of neuromuscular     blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining     adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with     adequate tidal volumes, in patients with high respiratory drive.   "
93355|NCT02064127|"     The investigators aim to evaluate in a retrospective study the performance of the Swiss     Emergency Triage Scale to identify at the door of the Emergency Department patients requiring     emergent intervention.   "
93356|NCT02064114|"     Study hypothesis:      Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an     obesity treatment after atrial fibrillation ablation.      Study design:      A prospective randomized, open-label clinical trial.   "
93357|NCT02064101|"     Previous studies have shown how triggered electromyogram (EMG) pedicle screw stimulation can     be used to effectively test correct pedicle screw placement in the lumbar and thoracic     vertebrae. Most papers agree that if more than 6mA of current are needed to elicit a response     the screw is correctly placed in the bone. If there is a response with less than 6mA there is     a strong likelihood of a breach of the pedicle wall or invasion of the spinal canal.     Typically this triggered EMG stimulation is done after all the screws have been placed with a     ball-tipped probe and is paired with intraoperative fluoroscopy to ensure correct placement     of the screws. Another method of testing the current for each screw is with a powered     screwdriver, which can stimulate and give a reading as the surgeon places each screw. Both of     these methods are currently used by surgeons, however the powered screwdriver has been found     to be a faster method. The investigator's aim with this study is to compare these two methods     of testing triggered EMG values. The investigators plan on doing this by testing each screw     with both the ball-tipped probe and the powered screwdriver, in order to see if there are any     statistically significant differences between the readings.   "
93358|NCT02064088|"     The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between     the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the     anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral     abdominal wall. The transversus abdominis plane block has shown promise for perioperative     analgesia, but data on the optimal dose regimen are limited.Following previous research of     optimal dose of local anesthesic solution, the investigators aim to evaluate if a volume     effect would lead to a better diffusion of the local anesthesic solution to the overall     nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of     0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for small volume group or 0,4 ml/kg of     0,1% levobupivacaine for high volume group).With the same dose of levobupivacaine, this     study aims to assess the impact of volume effect on analgesia efficiency as well as the     security as after ultrasound TAP block on one to five years' old children who undergo a     peritoneal-vaginal duct surgery.   "
93359|NCT02064075|"     Purpose:      - Vasospasm and secondary ischemia following subarachnoidal hemorrhage considerably affect     the clinical outcome. The purpose of this study is to determine whether crystalloid (Lactated     Ringer's solution) or colloid (hydroxyethyl starch) intravenous infusion is more effective in     the treatment of subarachnoid hemorrhage (SAH)      Treatment:      - Patients are randomly divided into two groups. Depending on the blood pressure of the     patients the members of the first group receive 15-50 ml/kg Lactated-Ringer's solution daily     as part of the treatment, while the others 15 ml/kg Lactated-Ringer's and 15-50 ml/kg     hydroxyethyl starch solution daily.      Measurements:        -  Neurological status of patients will be determined by the NIH Stoke Scale Score and the          Glasgow Coma Scale (GCS) on a daily basis.        -  The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow          Outcome Scale (GOS) 14 and 30 days following admission to our clinic.      Hypothesis:      -The prevalence of vasospasms, the mortality rate and the medium-term quality of life     following subarachnoid hemorrhage is improved if patients are treated with intravenous     colloid (hydroxyethyl starch) infusion compared to intravenous crystalloid infusion.   "
93360|NCT02064062|"     This study is looking at a new treatment, using the patient's own stem cells (the repair     cells of the body), to see whether this can help reduce pain and promote healing of the     Achilles tendon, without side effects.   "
93361|NCT02064049|"     The purpose of the study is to assess how feasible it is to treat and prevent the     transmission of Hepatitis C in the prison setting to achieve substantial reductions in the     incidence and prevalence of Hepatitis C.      It is hypothesised that a rapid scale-up of Hepatitis C Virus (HCV) treatment with     interferon-free Direct Acting Anti-virals (DAAs) in prison inmates will achieve a >50%     reduction in the incidence of HCV infection over a two year period in the prison setting.   "
93362|NCT02064036|"     We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate     following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively     and safely in a population of men with unfavorable intermediate and high risk localized     prostate cancer.      Our primary objective is to assess the feasibility and safety of a treatment strategy     incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant,     concurrent, and adjuvant androgen deprivation for a total of 28 months for men with     unfavorable intermediate or high risk localized prostate cancer.   "
93366|NCT02063984|"     This study will continue research designed to improve treatment outcomes for adolescent     substance use disorders by integrating neuroscience- and behaviorally-based treatments. In     particular, this project will be the first to evaluate whether Working Memory Training can     enhance cognitive function and reduce impulsive decision making to improve abstinence     outcomes. In addition, an adaptive abstinence-based incentive program will be evaluated as a     new method for intervening with those who do not respond to their first-line treatment.   "
93367|NCT02063971|"     The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing     cream used just after injection procedure and also the tolerance and the efficacy of the     F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002     placebo cream (comparison within subjects - half face method) to identify additional benefits     delivered by the product compared to a cosmetic procedure.   "
93368|NCT02063958|"     Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in     combination with everolimus.   "
93369|NCT02063945|"     Attention Deficit/Hyperactivity Disorder (ADHD) is one the most prevalent mental disorders     among children and adolescents, with a prevalence of 5% in western culture. The basics of the     disorder: inattentive and hyperactive/impulsive behaviors that manifest in a variety of     settings causing a dysfunction in everyday life. ADHD can be subdivided into three sub-types:     predominantly inattentive, predominantly hyperactive/impulsive or combined type. Common     co-morbidities of ADHD are disruptive disorders; Oppositional defiant disorder (ODD) being     the major one with about half of children with the combined sub-type ADHD and about a quarter     of children with the predominantly inattentive also suffering from ODD. Conduct disorder is a     co-morbidity for about a quarter of children with the combined sub-type ADHD. The     co-occurrence of these disorders is thought to have a negative effect on the outcome of both     of them.      Methylphenidate (MPH), short or long acting, is the mainstay of medical treatment for ADHD     patients, it's efficacy proven in a variety of studies. It should be noted that MPH has also     been proven to have a beneficial effect on children with disruptive behaviors. For children     with disruptive disorders Risperidone is the mainstay of medical treatment, and has been     proven in clinical trials.      To the best of their knowledge, a head to head study comparing these two drugs for the     treatment of pediatric patients with ADHD and co-morbidity of disruptive disorders was never     done before. The investigators aim is to examine the efficacy and tolerability of MPH vs.     Risperidone in this population. In addition, the investigators will apply DSM5's cross     cutting symptom measures scales is order to further define this unique subset of patients.      Disruptive mood dysregulation disorder (DMDD) is a new diagnosis in the latest version of the     diagnostic and statistical manual (DSM5). It's main features: sever recurrent temper     outbursts that are inconsistent with developmental level and occur on average three times a     week, the outbursts occur in at least two settings and the mood between outbursts is     irritable or angry. This diagnosis is in the differential diagnosis of ADHD with disruptive     disorders.   "
93370|NCT02063932|"     There might be a correlation between gastric mucosal microbiome and mucosal pattern     visualized by confocal laser endomicroscope.   "
93371|NCT02063919|"     The purpose of this study is to determine whether an association between endomicroscopic     pattern and colorectal mucosal microbiome exists.   "
93372|NCT02063906|"     Recently, the investigators face on the edges for treatment decision to decide adjuvant     systemic treatment, especially for patients who show discordance between stage and tumor     biology. The aim of this study was to compare the prognostic relevance of the TNM staging     system and intrinsic subtype in breast cancer patients who received curative surgery.   "
93373|NCT02063893|"     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors     into immunosuppressed mice, preventing an assessment on the immunologic interactions and     effects of CSCs. In this study, the investigators examined the vaccination effects produced     by CSC-enriched populations from histologically distinctmurine tumors after their inoculation     into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more     effective as an antigen source than unselected tumor cells in inducing protective antitumor     immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to     CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral     blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of     killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and     T cells were capable of selective targeting CSCs and conferring antitumor immunity.   "
93374|NCT02063880|"     Design: Randomized clinical trial involving hospitalized HIV-1 infected children. Children     will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy     (7-14 days). This trial will be unblinded.      Population: Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤     12 years of age.      Sample size: 360 children will be randomized (180 per arm).      Treatment: All infants will be treated with ART according to World Health Organization (WHO)     and Kenyan national guidelines.      Study duration: Enrollment into the study will occur over the course of 36-48 months and each     infant will be routinely followed for a maximum of 6 months.      Study site: Kenyan hospitals.      Primary hypothesis:      HIV-1 infected children hospitalized with severe co-infection either may be unsalvageable due     to too far advanced immunosuppression/co-infection or may benefit from urgent ART.      Secondary hypotheses:      Urgent ART during an acute infection could potentially result in increased risk of immune     reconstitution inflammatory syndrome (IRIS) or drug toxicities/interactions.      Specific aims:        1. To compare the 6 month all-cause mortality rate, incidence of immune reconstitution          inflammatory syndrome (IRIS), and incidence of drug toxicity in HIV-1 infected children          (≤ 12 years old) presenting to hospital with a serious infection randomized to urgent          (<48 hours) versus early ART (7-14 days).        2. To determine co-factors for mortality, IRIS, and drug toxicity. Potential cofactors will          include: baseline weight-for-age, height-for-age, weight-for-height (Z-scores), CD4,          HIV-1 RNA, type of co-infection, age, rate of viral load and CD4 change following ART,          immune activation markers, pathogen and HIV-1 specific immune responses.      Secondary aim: To determine etiologies of IRIS and to compare immune reconstitution to HIV,     TB, EBV and CMV following ART overall and in each trial arm.   "
93375|NCT02063867|"     The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality     improvement strategies to reduce multi-drug resistant organisms and healthcare-associated     infections in non-critical care units. The two strategies to be evaluated are:        -  Arm 1: Routine Care Routine policy for showering/bathing        -  Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing          for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen      Note that enrolled subjects represents 53 individual HCA Hospitals (representing ~190     non-critical care units) that have been randomized.   "
93376|NCT02063854|"     The present phase II/III, multicenter, randomized, double-blind, parallel group comparative     study is designed to evaluate the efficacy and safety of once-monthly oral administration of     NE-58095 delayed release (DR) tablets for 12 months in participants with involutional     osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5     mg tablets once daily for 12 months are set as the control group.   "
93377|NCT02063841|"     ERCP is associated with radiation exposure to the endoscopist and staff, which may be     significant at high volume programs despite the use of lead aprons. We hypothesize that     draping of the fluoroscopy image intensifier may significantly reduce staff radiation     exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable)     principle.   "
93378|NCT02063828|"     The purpose of this research study is to compare the effects of music and different levels of     device-guided breathing on anxiety and shortness of breath in lung cancer survivors.   "
93380|NCT02063802|"     The purpose of this clinical trial is to examine the effects of conjugated linoleic acid     (CLA) vs metformin along with an intervention program with healthy habits on body     composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular     and genetic changes in obese children.      Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass     index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.   "
93381|NCT02063789|"     Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined     the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune     diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared     to Ig 5% because it is expected the reduced hospitalization/treatment duration and less     adverse events related to volume overload.   "
93382|NCT02063776|"     Children on conventional haemodialysis (HD) die of heart disease. Also, they can be     malnourished and short. Haemodiafiltration (HDF) is a newer type of dialysis that achieves     better removal of toxins and excess fluid than HD. On HDF, adults have a longer survival and     children show improved growth, but mechanisms are not understood.      We will follow children in the UK and Europe to compare HDF and HD. We will monitor growth,     heart and blood vessel scans, blood markers and quality of life. If the 3H     (HDF-Hearts-Height) study shows reduced cardiovascular morbidity and better growth, HDF may     be adopted as the preferred type of dialysis in children.   "
93383|NCT02063763|"     This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and     Romiplostim as bridge therapy for splenectomy in adult patients with primary immune     thrombocytopenia.   "
93384|NCT02063750|"     Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in     patients with fibromyalgia (FM).      Material and Method: Sixty FM patients were randomized into two groups: an intervention group     (IG), in which patients performed muscle strength exercises using the Swiss ball, and a     stretching group (SG), in which patients performed stretching exercises. All patients     participated in 40-minute training sessions three times per week for 12 weeks. The IG     performed the following eight strengthening exercises using a Swiss ball: lateral rise,     simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row,     reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups     trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1     repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to     evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All     participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The     assessor was blind to patient allocation.   "
93385|NCT02063737|"     Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using     text-messaging impacts an emergency medicine clinician's Attitudes, Perceived Norms,     Self-Efficacy, Alertness Habits, Perceived Importance of Fatigue, Knowledge of     Sleepiness/Fatigue, and Perceptions of Environmental Constraints regarding behaviors that can     improve alertness during shift work.      Aim 2: To determine if text-messaging emergency care workers fatigue-reduction strategies in     real-time at the start and during shift work reduces worker perceived sleepiness and fatigue     at the end of shift work.   "
93386|NCT02063724|"     The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1     vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will     have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without     trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram,     laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine     administration.   "
93387|NCT02063711|"     Prenatal yoga has become a popular means of exercise during pregnancy.   "
93388|NCT02063698|"     This randomized pilot clinical trial studies whether auranofin will relieve pain following     paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is     a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being     studied to see if it will decrease pain following paclitaxel.   "
93389|NCT02063685|"     Recently, the availability of R has substantially changed therapeutic approach to FL     patients, since its combination with chemotherapy has improved response rates, progression     free survival (PFS) and overall survival (OS). Based on the results of recently completed     randomized studies the standard treatment for patients with FL should consist of an initial     therapy with R-CHOP combination followed by two-year maintenance with R. Although results of     randomized trials confirmed that this approach results in an improved patients' outcome and     made a step forward in the management of patients with FL, one important question that can be     raised is if this approach is really needed for all patients with FL or if some of them could     benefit from a reduced intensity treatment achieving the same results in terms of outcome and     survival . This question is of particular interest for newly diagnosed patients for whom     maintenance does not affect OS.      More recent data demonstrated that the outcome of patients with FL can be further predicted     by evaluating the quality of response to therapy studying minimal residual disease (MRD).     This project addresses the objective of evaluating if combining clinical response assessed on     FDG-PET scan and molecular response measured through MRD detection could permit to single out     groups of patients at different risk of progression and to consequently modulate maintenance     therapies, with the aim to provide clinicians a more rational use of the available diagnostic     and therapeutic resources.   "
93390|NCT02063672|"     To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of     femoropopliteal artery (SFA) in-stent restenosis (ISR).   "
93391|NCT02063659|"     The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on     the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA)     levels.   "
93459|NCT02062762|"     The main objective of the current study is to evaluate whether a mindfulness based     intervention delivered online can provide an effective resource for increasing psychological     well-being among students. In addition, explore potential mechanisms through which the     training lead to improvements by means of mediational analyses, with hypothesized variables     like positive/negative affect and attention regulation.   "
94256|NCT02052349|"     This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333 when     delivered within different sites of the gastrointestinal tract in 12 healthy subjects.   "
93392|NCT02063646|"     Several preliminary studies have shown that diet can have beneficial effects on cognitive     decline. Among food shown to have such effects are some polyphenols from selected botanicals.      Preclinical studies have concluded that polyphenols play a role in moderation of oxidative     stress and inflammation, increased neuronal signaling, and improved metabolic function among     other effects. Noteworthy, a positive and statistically significant association between the     midlife level of polyphenol intake and cognitive function assessed 13 years later was found     in a cohort of 2574 adults.      Several mechanisms may be involved in these positive effects of food polyphenols on cognitive     function in older adults: experimental studies suggest that polyphenols display     neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and     inducing neurogenesis, and might prevent age-related damage to the central nervous system     through their antioxidant and anti-inflammatory activities.      Based on these promising results, a food supplement from botanicals offering complementary     polyphenol profile was developed. This food supplement is aimed to aid at maintenance of     cognitive function in older adults.   "
93393|NCT02063633|"     Technologic advances in the field of radiation oncology have made in possible to deliver a     highly conformal and accurate radiation dose to a target tissue. Accompanying the rapid     implementation of these novel techniques is often a reduction in the radiation margins, which     reinforces the importance of accurate target delineation, and reduces the side effect of     therapy.      F-18 FDG PET/CT is widely used in oncology, including complete whole body staging, restaging     and monitoring of tumor response in different types of cancers. As to non-oncology     application, inflammation in almost any tissue will result in increased FDG accumulation.     However, the normal tissue with sparing radiation may show subtle change, and would be     difficult to be detected. FDG PET/CT was limited in the spatial resolution of 5 mm and low     FDG-avid disease. To be evaluation of the interval change of metabolic response before and     after radiotherapy of thoracic malignancies, we plan to initiate a prospective study trail     the takes advantages of recent technical advances of technique in 4-dimensional PET/CT (4-D     PET/CT) with respiratory gating system.      Respiratory motion creates artifacts in PET and PET/CT images, and can alter diagnosis. The     tumor edge would be blurred due to respiratory movement, and be underestimated the uptake     value. Also, semi-quantitative measurement, standard uptake value (SUV), combined with     parameters such as the lesion site and shape, which is commonly used to make the final     assessment of disease would be mis-estimated.      The study aims to investigate the correlation of 4-D PET/CT with respiratory gating methods     and free breathing PET/CT when processing primary thoracic malignancy and normal tissue     effect.   "
93394|NCT02063620|"     IVRA can be performed with many local anesthetics and adjuvant agents. In our study we     planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus     ketamine.   "
93395|NCT02063607|"     This is an open label, dose ranging, phase1a/1b clinical trial to study the safety,     Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy     volunteers and antiviral activity of once weekly Peglamda administration in combination with     daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the     study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and safety     in Hepatitis C naive patients.   "
93396|NCT02063594|"     This is a randomized, double-blind, single dose, dose-escalation study to evaluate the     safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection)     administered intravenously to healthy volunteers. In addition, computed tomography (CT) scans     will be acquired to measure radiographic density in regions of interest (ROI) at times from     3-5 hours and up to 72 hours following NCTX administration.   "
93397|NCT02063581|"     This Phase I, open-label, randomized, 2-period crossover study was designed to determine the     relative bioavailability of ipatasertib administered as capsule and tablet formulations to     healthy adult volunteers. Participants will be randomized to one of two treatment sequences     to receive a single oral administration of ipatasertib in tablet or capsule formulation     followed, after a washout period, by a single oral administration of ipatasertib in the     second formulation. Pharmacokinetics will be assessed, and standard physical and clinical     evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.   "
93398|NCT02063568|"     The purpose of this study is to evaluate the differences in blood clotting seen in healthy     patients given two different doses of oxytocin following cesarean delivery. The secondary     objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and     differences in blood loss with the two separate doses of oxytocin.   "
93399|NCT02063555|"     This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of     DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative     and HIV positive adults previously vaccinated with BCG. The goals of the trial are to     determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at     different dose levels, ranging from 0.1 to 1 mg.   "
93400|NCT02063542|"     Previous study demonstrated that the condition of central cholinergic nerve is important for     the postoperative cognitive dysfunction. In present study investigators hypothesized that the     acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative     cognitive changes in aged patients undergoing osteopathic surgery.   "
93401|NCT02063529|"     PURPOSE:      A primary aim of phase II FOCULM study is to explore whether cetuximab in combination with     FOLFOXIRI as first treatment could improve surgical conversion in patients with KRAS/NRAS     wild-type, unresectable liver - only metastases of colorectal cancer. The first secondary aim     is to evaluate the safety and tolerability of the chemotherapy of FOLFOXIRI plus Cetuximab     targeted therapy regimen in this patient population.      Secondary aims include determination of objective response rate, progression free survival,     quality of life and time to recurrence for patients undergoing complete resection and/or     ablation of liver.   "
93402|NCT02063516|"     To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and     Proseal LMA) and to observe any associated complications.   "
93460|NCT02062749|"     The goal of this clinical research study is to find the highest tolerated dose of heated     intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers also     want to learn more about the ways that pediatric and young adult colon cancer may be     different from colon cancer in adults.   "
93403|NCT02063503|"     There is a consensus that exercise therapy should be used as a therapy approach in CLBP but     little consensus has been reached about the preferential type of therapy. There occurs to be     a wash out effect because of the heterogeneous character of CLBP patients. Therefore there is     a need for the development of CPR's. Objectives for this trial are first, the derivation of     clinical prediction rules (CPR) to predict treatment response to three forms of exercise     therapy for patients with nonspecific chronic low back pain (CLBP). Secondly, to validate a     clinical prediction rule for the three forms of exercise therapy for patients with     nonspecific CLBP.      The study design is a Randomized controlled trial. Patients with non-specific low back pain     of more than three months duration are recruited at the Antwerp University Hospital. After     examination patients are randomly assigned to one of three intervention groups: motor control     therapy, general active exercise therapy and isometric training therapy. All patients will     undergo eighteen treatment sessions during nine weeks. Measurements will be taken at     baseline, nine weeks, six months and at one year. The primary outcome used is the Modified     Oswestry Disability Questionnaire. For each type of exercise therapy a clinical prediction     rule will be derived and validated. For validation the CPR will be applied to divide each     treatment group into two subgroups (matched and unmatched therapy) using the baseline     measurements. We predict a better therapy effect for matched therapy.      Never before a RCT design was performed for the development of a CPR for exercise therapy in     CLBP patients. Only one CPR was described in a single arm design for motor control therapy in     sub-acute non-radicular LBP patients. In this study, a sufficiently large sample will be     included in both the derivation and validation phase.   "
93404|NCT02063490|"     The study aim is to test the efficacy of one-year nurse-led interventions to improve the     medication intake behaviour of chronic dialysis patients. The investigators hypothesis is the     interventions leading to a 15% mean increase in intake, compared to standard care.   "
93405|NCT02063477|"     The objective of the study is to evaluate the effect of consumption of a food supplement rich     in procyanidins extracted from the bark of French pine, Oligopin®, on blood pressure of     people with mild / moderate degree of hypertension. Furthermore, the effect Oligopin®     consumption on markers involved in the development of hypertension, and endothelial function     in key enzymes that regulate blood pressure, inflammation and oxidation are considered. Also,     try to advance the understanding of the molecular mechanisms that regulate blood pressure.   "
93406|NCT02063464|"     Background:        -  Monocytes are a type of white blood cell found in human blood. They help the immune          system. Researchers have found that monocytes taken from the blood of healthy people can          kill tumor cells. Now they want to know if monocytes taken from the blood of people with          ovarian cancer can kill tumor cells.        -  In addition, native host anti-tumor cell mediated immune mechanisms may play a role in          clinical outcome of epithelial ovarian cancer; data indicate that the presence of          intra-tumoral CD3+ T-cells was shown to prognosticate improved outcome in advanced          ovarian cancer. Furthermore, non-cellular components in the blood, such as exosomes, may          influence outcome.      Objective:      - To see if monocytes taken from the blood of people with ovarian cancer can kill tumor     cells.      Eligibility:      - Women 18 years and older with ovarian cancer.      Design:        -  Participants will be screened with:        -  Medical history and physical exam.        -  Blood tests.        -  CT scan of the chest, abdomen, and pelvis and/or an MRI. For these scans, they will lie          in a machine that takes pictures of their body.        -  A small amount of blood (two tubes) will be collected by needle during one visit.   "
93407|NCT02063451|"     Obesity has reached epidemic levels in the United States, and is on the rise in many     industrialized nations. The rate of recidivism for long-term weight loss is substantial and     presents a critical problem given the importance of obesity as a modifiable risk factor for     diseases like type 2 diabetes. Further, the comorbidity of depression with diseases like     obesity, type 2 diabetes, and cardiovascular disease suggest that there may be an underlying     shared biology for diseases of metabolic dysfunction and emotional dysregulation. The shared     biology of these diseases may actually promote the precipitation and exacerbation of comorbid     conditions, impacting the success of treatment. Endogenous opioid systems regulate a number     of physiological and psychological processes including mood, energy management, and reward.     Endogenous opioid µ-receptor-mediated reward processing is thought to be involved both in the     short-term control of eating and hedonic food consumption, based on data in animal models.     The present proposal will examine the function of the µ-opioid receptor (MOR) system in lean     and obese human volunteers following an overnight fast and the change in µ-opioid receptor     occupancy (i.e., endogenous opioid release) following the consumption of a standardized meal     using PET imaging with the µ-selective radiotracer [11C]carfentanil. The obese individuals     will be retested in the fasting and fed state following a 15% weight loss with a Very Low     Calorie Diet. Further, the investigators will evaluate the function of the MOR system within     the context of the individual's metabolic and psychological profile including aspects of mood     and inhibitory control. This information will provide the neurobiological bases to develop     novel avenues of intervention based on individual variations in central mechanisms associated     with motivational systems and appetite and their potential role in weight regain.      The investigators hypothesize that overeating in chronically obese individuals will be     associated with a dysregulation of MOR system function, manifested by reductions in baseline     MOR availability (binding potential, BP) in limbic and reward circuitry, and lower release of     endogenous opioids after a standard meal, compared to lean volunteers. The latter is observed     as acute reductions in the BP measure after meal ingestion.   "
93408|NCT02063438|"     The purpose of this study is to examine pain associated with thoracotomy (incision made     during surgery to obtain access to your thoracic cavity) and how the closure technique may     influence postoperative pain. Two types of routinely selected thoracotomy closure techniques     will be examined; pericostal and intracostal sutures. The investigators hypothesize that     intracostal sutures will result in less postoperative and chronic pain as a result of less     compression of the intercostal nerve.   "
93409|NCT02063425|"     The objective of this study is to better characterize the mechanisms of action of fluoxetine     in motor recovery and more specifically to identify the neurophysiological substrate     underlying fluoxetine-induced motor recovery in stroke.      In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to     assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and     integrity.   "
93410|NCT02063412|"     The objective of this study is to compare the possible time savings from reduction of nursing     and pharmacy time to manage AEGC patients using capecitabine-based regimens versus     traditional intravenous chemotherapy in the Hong Kong public hospital setting.   "
93411|NCT02063399|"     The purpose of this study is to determine if the screening of nasopharyngeal carcinoma using     plasma Epstein-Barr virus DNA analysis would result in the down-staging of the NPC cases in     asymptomatic individuals.   "
93412|NCT02063386|"     To assess the absorption, distribution, metabolism and excretion of a single dose of 14C     labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if     formed, metabolites.   "
93413|NCT02063373|"     Treatment: five intro-articular Hyaluronic Acid injection      Assessment has two parts, that are as follow:        1. Postural stability and risk of fall assessment using Biodex stability index and Timed          up and Go test        2. Gait and stair climbing assessment using Vicon motion capture system synchronized with          four force plates.      For knee OA subjects, assessment was done in week one or before injection; and for healthy     controls one assessment was performed.   "
93414|NCT02063360|"     The purpose of this study is to determine if there is an interaction in healthy subjects     taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.   "
93415|NCT02063347|"     Both clinical and experimental studies demonstrate the importance of the pre-existing, ie     innate collateral supply in different vascular regions. Furthermore, pathophysiological     considerations and experimental data imply an important role for the association of     collateral function between different vascular regions.      STUDY HYPOTHESES 1. In the absence of atherosclerotic stenoses, there is a direct association     between the collateral function in the coronary, renal and peripheral circulation. 2. The     increase in plasma renin in response to a unilateral main renal artery balloon occlusion is     inversely related to its functional collateral supply. 3. The decrease in renal vein oxygen     saturation in response to a unilateral main renal artery occlusion is inversely related to     its functional collateral supply.   "
93416|NCT02063334|"     The purpose of the study is to investigate whether a high-dose vitamin D3 oral bolus (2000     micrograms) produces marked vitamin D receptor target gene expression response and whether     there is large inter-individual variation.   "
93417|NCT02063321|"     The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients     with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology     survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes,     type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of     prognostic factors leading to development of DME.   "
93418|NCT02063308|"     By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the     blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's     disease who take OAA for one month have any side-effects.   "
93419|NCT02063295|"     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of     beloranib in obese subjects with hypothalamic injury.   "
93420|NCT02063282|"     The investigators hypothesize that development of symptoms characteristic of Clostridium     difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of     non carriers and expect to find risk factors for development of symptomatic clostridium     difficile.   "
93421|NCT02063269|"     Butyrylcholinesterase (BuChE) activity is increasing in Alzheimer Disease (AD) process (Lane     et al., 2006). BuChE wild type has stronger butyrylcholine esterase activity than BuChE K     variant allele and this strong activity can affect AD brain negatively by choline depletion.     Rivastigmine has unique dual action - acetylcholine esterase inhibition and butyrylcholine     esterase inhibition. Therefore, rivastigmine can lower serum butyrylcholine esterase activity     and delay functional decrease of Fluorodeoxyglucose positron emission tomography (FDG PET)     images in AD patients with BuChE wild type allele by strong BuChE inhibition.      It suggests that rivastigmine can affect brain function differently by BuChE genotype in AD.     Therefore, we will try to find the different changes of serum butyrylcholine esterase     activity by ELISA and functional and structural changes of brain between BuChE wild type and     K-variant type by FDG PET and MRI pre and post images after 12 month use of rivastigmine.        1. Primary objective:             1. the mean changes of Standardized Uptake Values (SUVmean) in PET imaging             2. the mean changes of serum BuChE activity between BuChE wild type and K-variant               type.        2. Secondary objectives:             1. the mean changes of cortical thickness in brain MRI             2. the cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale               (ADAS-cog)             3. the cognitive changes in Mini-Mental State Exam (MMSE)             4. the daily function changes by Alzheimer's Disease Cooperative Study - Activities of               Daily Living (ADCS-ADL)             5. the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI)             6. the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes               (CDR-SB) between BuChE wild type and K-variant type.   "
93422|NCT02063256|"     Setting. Outpatient fertility clinic.      Aim. Investigate if a modification in nutritional habits may improve in the short term the     qualities of human sperm, testing two hypothesis:      i) that adding to the diet a natural whole food rich in polyunsaturated fatty acids (PUFA)      OR      ii) that reducing the intake of saturated fatty acids and increasing the consumption of PUFA     may affect beneficially sperm parameters.      Population. N. 100 hypofertile male subjects attending a fertility clinic.      Type of study. Interventional study. No drugs or pharmacologic supplementation will be     required nor allowed.      Two different type of intervention are scheduled:        -  Supplementation to western style diet with nuts, naturally rich in PUFA        -  Diet modification increasing intake of PUFA-rich foods and cutting the consumption of          food rich in saturated fats.      Protocol        -  Baseline visit and recruiting.        -  Informed consent        -  Randomized allocation to treatment group in a 1: 1 manner      Blinding. Investigators deputed to sperm analysis and statistician are blinded as to type of     intervention.      Phases:        -  i) basal        -  ii) after 15 weeks That interval is chosen because encompasses an entire spermatogenesis          cycle.      Outcomes. Primary        -  sperm count, concentration,morphology and mobility.      Secondary:        -  serum folate assay,        -  plasma PUFA (ALA, EPA, DHA) assay,        -  body weight and BMI variation      Statistics. A comparison for all sperm parameters (count,concentration,morphologic     abnormalities, mobility) will be carried out by an analysis within groups and within patient.   "
93423|NCT02063243|"     This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with     a argon gas based device in treating keloids and hypertrophic scars in population consisting     of all Fitzpatrick skin type patients   "
93424|NCT02063230|"     A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,     ARRY-142886) in patients with hepatic impairment and healthy subjects.   "
93425|NCT02063217|"     The purpose of this study is to change the concentration of amyloid-beta in human     cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.   "
93426|NCT02063204|"     A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,     ARRY-142886) in subjects with renal impairment and healthy subjects   "
93427|NCT02063191|"     This is a single center, non-randomized, unblinded study of patients who are followed at     Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated     diagnostic electrophysiology (EP) study with or without ablation. During the procedure,     events of atrial fibrillation, sinus rhythm and bundle branch block that may occur during the     course of the case will be saved electronically and analyzed offline. The stored data will be     evaluated off-line for changes in activation timing of the near and far field ventricular     signals of the stored events.      This proof-of-concept study will attempt to assess whether atrial fibrillation, or bundle     branch block can change activation timing compared to baseline sinus rhythm. If no     significant activation change is seen, then this finding can be used as a basis to     distinguish ventricular tachycardia from atrial fibrillation in future rhythm discrimination     methods.   "
93461|NCT02062736|"     The purpose of the study ( observational and prospective ) is to evaluate the efficacy and     tolerability of the methadone maintenance treatment in patients addicted to heroin. The     efficacy and tolerability are assessed by correlating to the adequacy of the dosage of     methadone. The patients will be observed for two years.   "
93428|NCT02063178|"     Purpose: This study aims to take the procedural and research-based lessons learned from a     pilot weight loss intervention (IRB # 13-02563-XP), conducted by The University of Tennessee     Health Science Center in 2013, and apply them to the current study of 204 active duty     military personnel. The pilot study translated and tailored the Look Ahead weight loss     intervention to an overweight/obese active duty U.S. Air Force population, while     accommodating the lifestyle and environment that is unique to military members and evaluate     materials and procedures used.      Rationale: Being overweight is now by far the leading medical reason for rejection in the     military. Unfortunately, the impact of weight problems on the military does not stop with     those turned away from military service. From 1998 to 2008, the Armed Forces Health     Surveillance Center reported the percent of active military members who experienced medical     encounters for overweight or obesity significantly increased. The estimated total days of     work lost from absenteeism associated with active-duty personnel who are overweight or obese     was 658,000. Using Department of Defense (DOD) estimates of average daily based, it was     estimated that overweight and obesity costs the DOD $103 million dollars in health care costs     annually. Note this estimate is for active duty personnel only. Furthermore, obesity is a     major cause for the discharge of uniformed personnel.      The current study is inspired by the successful Look Ahead trial, a behavioral science     obesity intervention treatment program that included: a collaborative approach, education,     behavioral support, and motivational interviewing. The unique nature of this weight reduction     study is significant. To our knowledge, there had not been a successful translation of a     highly efficacious obesity treatment in the military until The University of Tennessee Health     Science Center implemented a pilot version of the Fit Blue program for active duty U.S. Air     Force members in 2013. Following a successful pilot and extant results from the Look Ahead     trial, Investigators expect success during the full scale Fit Blue study.   "
93429|NCT02063165|"     The purpose of this study is to understand the role of a dietary oil to alter chronic disease     risk factors in women who are at risk for heart disease and/or diabetes. The investigator's     previous study showed that safflower oil reduced trunk fat mass in women with diabetes. The     investigators believe safflower oil can also attenuate criteria of metabolic syndrome through     reduction in trunk fat mass.   "
93430|NCT02063152|"     This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and     malignancies at other sites, after the detection of screening positives and the diagnosis for     primary cervical cancer.   "
93431|NCT02063139|"     Aim of the study is to investigate the short-term growth in children with asthma aged 5-11     years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20     micrograms per day   "
93432|NCT02063126|"     The main objective is evaluate to safety and efficacy of oral Reconnect ® (food     supplementation composed by Coenzyme Q10, NADH, phosphoserine y vitamin C) on the maximum HR     during an exercise test in CFS   "
93433|NCT02063113|"     The aim of this study is to determine whether the presence of vulnerability detected by     geriatricians is associated with treatment discontinuation in older patient. During the     comprehensive geriatric assessment realized before the decision-treatment, the following data     are recorded and their impact in the therapeutic changes will also be analysed: comorbidity,     age, depression, functional status, the cognitive impairment and malnutrition.   "
93434|NCT02063100|"     -Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of     patients with primary glomerulonephritis compare with Losartan potassium.   "
93435|NCT02063087|"     The investigators will test the impact of a decision aid, Head CT Choice, to determine if its     use improves parents' knowledge and engagement in decision making and safely decreases     healthcare utilization in children presenting to the emergency department with blunt head     trauma.   "
93436|NCT02063074|"     The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle     factors on bone health in young women over a 20-year time period. It is our primary     hypothesis that premenopausal women with irregular periods or endocrine issues related to     estrogen will have significantly poorer low back and hip bone health when compared to     regularly menstruating women. It is our secondary hypothesis that long-term assessment of     changes in endocrine function and lifestyle behaviors will assist in establishing risk     factors for osteoporosis in young women. This study will include 1000 premenopausal women.     The women will participate in the collection of a blood sample, bone scan, body fat measures,     and lifestyle questionnaires. In addition, we hope to use this initial study to develop a     group of women to follow throughout menopause, with additional visits occurring every 5 years     over the course of their life.   "
93437|NCT02063061|"     The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is     an effective treatment for erectile dysfunction.   "
93438|NCT02063048|"     The purpose of this study is to compare the effectiveness of text message-based support to     usual care at promoting weight loss in patients with pre-diabetes.   "
93439|NCT02063035|"     Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine     surgery will decrease the overall blood loss post-operatively. This reduction in blood loss     will reduce the need for transfusion. In addition it will also significantly reduce the cost     of the surgical procedure.      Specific Aim 1: The goal of this study is to quantitatively assess whether topical     application of tranexamic acid placed into the surgical wound during lumbar spine surgery     will decrease post-operative blood loss, thus lowering the need for blood transfusions. By     reducing the number of transfusions participants can avoid the well-known complications     associated with them. The investigators do not plan on measuring serum tranexamic acid     levels.      Several meta-analyses and level I studies have shown that intravenous (IV) administration of     tranexamic acid is effective in reducing postoperative blood loss and the need for     transfusion.   "
93440|NCT02063022|"     Controlled, randomized phase III study, with the intent of optimizing the treatment of not     metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs     intensive treatment. Both arms will receive an induction treatment followed by surgery     (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on     the basis of the response to the induction treatment (good or poor)   "
93456|NCT02062801|"     The combined spinal epidural (CSE) technique has become increasingly popular for labor pain     because of its rapid onset and superior first stage analgesia. However, increased risk for     early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various     factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine     administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody     has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of     CSE administration during labor. The purpose of this study is to measure the incidence of     EPFB after combined spinal epidural analgesia using standard definitions. The incidence of     EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the     time of CSE placement.   "
93441|NCT02063009|"     Perioperative hemodynamic optimization requires monitoring adapted to the risks of the     surgery and the patient. We currently use a local hemodynamic protocol based on the data of     the literature. According to this protocol, specific patients may require cardiac index and     central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with     the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich,     Germany). The technique is based on the injection of a cooled bolus of saline into a central     vein with a central venous catheter (CVC). The variation of temperature is measured with an     arterial femoral catheter and allows the assessment of the cardiac output according to     Stewart-Hamilton's theory. Many studies showed the reliability of this technique.      In our institute, most of the patients are fitted with a port for chemotherapy or parenteral     nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the     opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be     more difficult because of the port. It may be interesting to use the port for TPTD in order     to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by     the port was as reliable as the classical measurement with a CVC.   "
93442|NCT02062996|"     Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic     agent in over-the-counter decongestant sprays. It is used extensively at Nationwide     Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding.     Although there is generally limited vascular absorption, when administered in larger doses,     uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH     anesthesia department recently reported a case of oxymetazoline induced postoperative     hypertension in a three-year-old child following inferior turbinate reduction and     adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline     and insert a varying number of pledgets during surgical procedures or instill oxymetazoline     drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding     the method of administration and the absorption of oxymetazoline or the dose-response     relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies     would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric     population.   "
93443|NCT02062983|"     Early identification of patients at risk for cardiotoxicity represent a primary goal for     cardiologist and oncologist      From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function     though its operator dependent. The use of other technique such as endomyocardial biopsy, is     troublesome in clinical practice      Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left     ventricular ejection fraction (LVEF). This technique provides morphological, functional,     perfusion, and viability information in one assessment. It is expensive and time consuming     but id the diagnostic method of choice for patients with technically limited images from ECG     and in patients with discordant information that is clinically significant from prior tests   "
93444|NCT02062970|"     Septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in ICV.     Mortality associated to septic shock varies from 30 to 50%. It follows a systemic response of     the organism to a severe infection, associated with a circulatory failure marker by an     arterial hypotension and a vascular hyperactivity to vasoconstrictor agents.      The mechanisms involved on one hand an activation of white blood cells inflammatory system     and the vascular inflammatory system; and on the other hand on imbalance in hemostatis     characterized by an activation of the coagulation and an inappropriate fibrinolysis leading     to a disruption of microcirculation in the context of a disseminated intravascular     coagulation (DIVC).      This inflammatory and thrombotic cellular activation is strongly associated with the     phenomenon of vesiculation; leading to the production of cellular microparticles (MP) by     blood cells and vascular cells.      MP are membranous vesicles, resulting in the reassortment of membrane phospholides in     response to an activation of cellular apoptosis. They have been initially described as new     actors of hemostatis. Indeed, the expression of phospholipid serine and tissular factor (TF)     confer them a procoagulating activity, which increases in patients undergoing septic shock.      The finding of a fibriniolytic activity of the cellular MP suggests the existence of     compensating mechanisms with a procoagulating activity. This confers to MP a key-role in the     control of the coagulolytic balance.      Our recent researches suggest that endothelial and white blood cells MP produce in vivo     plasmin.      They carry into the main circulation a fibrinolytic activity which is partially beyond the     physiological inhibitors activity (PAI-1, x 2 antiplasmin). Preliminary findings show that     this ability of plasmin generation is important in patients affected with septic shock.      Our hypothesis is that an increase in plasmin generation by MP compensates the risk of     occurrence of microthrombosis, modulating therefore the vital prognosis of patients with     septic shock.      The coagulolytic balance of MP, which is resulting of their own procoagulating and     fibrinolytic activities could claim the status of new pronostic marker relevant in patients     with septic shock.   "
93445|NCT02062957|"     1. recruit 50 patients with atrial fibrillation and 30 controls        2. endovascular function assessment with Peripheral Arterial Tonometry (PAT)        3. follow up the occurence of AF   "
93446|NCT02062944|"     The significance of this clinical trial lies in its potential to increase the success of     immunosuppression (IS) therapy withdrawal in liver transplant (LT) recipients, thus     decreasing the negative impact of IS on their long-term outcomes. Lifetime immunosuppression     (IS) with standard agents, the calcineurin inhibitors (CNI) cyclosporine and tacrolimus     (TAC), is currently required at clinically recommended doses and trough levels to prevent     allograft rejection. However, this occurs at the significant expense of long-term CNI     toxicity, i.e. chronic kidney disease (CKD), hypertension, hyperlipidemia, diabetes,     infections and malignancy. With improvements in early graft and patient survival, long term     adverse IS effects have become increasingly important in this rapidly expanding patient     population. The strategies to reduce long term CNI toxicity include dose minimization that     still leaves patients on CNI therapy, conversion to non-CNI therapy, or even complete IS     withdrawal. The second approach, conversion to non-CNI IS therapy, is attractive in the     potential to stabilize or improve renal function and other CNI toxicities. One such     non-nephrotoxic IS agent, the mammalian target of rapamycin inhibitor (mTOR-I) SRL, has a     different mechanism of IS action and studies have shown that CNI to SRL conversion can     stabilize renal dysfunction with a low risk of rejection. Yet even with these possible     benefits, patients on SRL are still subject to lifetime IS therapy with side effects and     costs, highlighting the need to investigate the strategies that promote full IS withdrawal     without rejection (3rd approach), also known as 'operational tolerance'.   "
93457|NCT02062788|"     Elective colectomy procedures typically require bowel preparation starting 2 days prior to     the surgery. Osmotic laxatives such as Colyte® are administered 2 days prior, and Nothing by     mouth (NPO) is required 1 day prior to ensure no fecal residue is left in the bowel. Though     it may ensure a cleaner and safer surgery, this longer period of starvation increases insulin     resistance and may increase post-op complications. However, there is evidence that     administration of oral rehydration solution(ORS) prior to surgery reduces insulin resistance.     Our purpose is to evaluate the difference of insulin resistance in those who received ORS 1     day prior to surgery and those who did not.   "
93447|NCT02062931|"     Stem cells (SC) are the foundation cells for every organ, tissue and cell in the body. They     are undifferentiated blank cells that do not yet have a specific function. Under proper     conditions, they begin to develop into specialized tissue and organs. They are     self-sustaining and can replicate themselves for long periods of time. They have the     remarkable potential to develop into many different cell types in the body. They serves as a     sort of repair system for the body, they can theoretically divide without limit to replenish     other cells as long as the person is still alive. Premature ovarian failure (POF) is the loss     of ovarian function in women less than 40 years. It is associated with sex steroid     deficiency, amenorrhea, infertility and elevated serum gonadotropins. POF occurs in 1 % of     women. In majority of cases the underlying cause is not identified. Management essentially     involves hormone replacement and infertility treatment. This work aimed to evaluate the     therapeutic potential of Autologous MSC transplantation in women suffering from Premature     Ovarian Failure.   "
93448|NCT02062918|"     Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic     mechanical-postural low back pain.      Methods: A randomized controlled trial was carried out, involving 60 consecutively selected     patients with chronic low back pain randomly allocated to an intervention group (use of     abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the     baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion.     The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient     satisfaction (Likert scale); and number of anti-inflammatory pills ingested.     Intention-to-treat analysis was also used.      Hypothesis - abdominal belt will improve pain in chronic low back pain patients   "
93449|NCT02062905|"     The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained     release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the     treatment of the signs and symptoms of chronic allergic conjunctivitis.   "
93450|NCT02062892|"     The investigators hypothesize that switching kidney transplant patients on     tacrolimus/sirolimus long-term maintenance immunosuppressive drug regimens to     tacrolimus/everolimus, will not only be safe, but will lead to better kidney function than     patients staying on tacrolimus/sirolimus due to the lower potential of everolimus to enhance     calcineurin inhibitors toxicity and/or its ability to even reverse some of the negative     effects of calcineurin inhibitors on vascular endothelial and kidney function. To test this     hypothesis vascular endothelial biomarkers will be analyzed in blood plasma samples and     kidney dysfunction biomarkers in urine samples via liquid chromatography tandem mass     spectrometry to evaluate whether switching kidney transplant patients on tacrolimus/sirolimus     to tacrolimus/everolimus will lead to better kidney and endothelial function after one year     and two years.   "
93451|NCT02062879|"     This study will compare ketamine and hydromorphone as alternative patient-controlled     interventions for trauma-related pain. Patients receiving ketamine PCA are expected to     require less total and breakthrough opioid and to have similar or improved objective pain     scores. Patients receiving ketamine are also expected to have shorter duration of     supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary     toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is     further expected to be associated with decreased intensive care unit and hospital lengths of     stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and     lower report of chronic pain syndromes.   "
93452|NCT02062866|"     To compare healing time, scar size, aesthetic outcome, and complication rates following     second intention healing or purse string closure of surgical wounds on the trunk or     extremities. This study, will allow surgeons to make informed decisions on whether purse     string closure is superior to that of second intention healing and thus worth considering or     inferior and not worth performing.   "
93453|NCT02062853|"     The primary aim of this study is to evaluate the effects of prospective patient education on     patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment     of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms.     Specifically, this study aims to determine if prospective patient viewing of an educational     video delineating treatment effects and expectations improves patient satisfaction and     treatment completion rates.   "
93454|NCT02062840|"     The investigators have observed in an open trial that a single session of whole body     hyperthermia (WBH) induced rapid antidepressant effects that persisted for at least a week in     patients with major depression (MDD) severe enough to warrant inpatient hospitalization. In     addition to reducing depression, the single session of WBH induced a prolonged reduction in     mean core body temperature, consistent with basic science data from our group suggesting that     hyperthermia activates a skin-to-brain pathway that have been shown in animals to be     important for mood and body temperature regulation. Consistent with this known anatomy in our     preliminary study in depressed patients, reductions in core body temperature were highly     correlated with reductions in depressive symptoms over the same time period (one week post     WBH). Moreover, patients with higher mean core body temperature prior to treatment had     enhanced antidepressant effects. Because increased body temperature is an outcome of poor     functioning in the skin-to-brain pathway activated by WBH our data suggests that WBH may     actually sensitize this pathway in ways that promote changes in brain functioning known to     promote emotional well-being. The results of our first open trial have encouraged us to     conduct a larger, more rigorous placebo-controlled, double blind study of WBH for MDD, which     is currently underway at the University of Arizona Medical School. Missing from our     assessments in this ongoing double-blind study is any measure of the impact of WBH on brain     function. The current proposal addresses ths gap in our investigative portfolio by proposing     to conduct a second, randomized trial of active vs. sham WBH that will examine the impact of     WBH on measures of brain function known from prior studies to be important for both     depression and its treatment.   "
93455|NCT02062827|"     To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes     Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent     glioma To determine the safety and tolerability of the maximum dose for laboratory engineered     Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent     glioma   "
93458|NCT02062775|"     The purpose of this study is to determine if self-fixating polyester mesh will have lower     incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when     used for laparoscopic inguinal hernia repair.   "
93464|NCT02062697|"     Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies     in western civilized countries, with an estimated prevalence in Europe and the US of 752,600     in 2007 and 59,828 deaths annually.      State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum     cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is     low, and both tests are not effective enough at detecting EOC early enough to improve     clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological     confirmation. These findings underline the importance for an effective test for early     detection of EOC.      In the current project we will obtain a lavage of the uterine cavity. It will be investigated     whether cells from EOCs or genetic material from those cells can be detected in the lavage     fluid.      Aim of this study:      There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.   "
93465|NCT02062684|"     The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod     administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy     with persistent proteinuria of between 1-6 g/day.   "
93466|NCT02062671|"     In patients with polycystic kidney disease, pain may be resistant to drug therapy and may     reduce quality of life. This study investigate the effect of renal denervation on this pain.   "
93467|NCT02062658|"     This study investigates if a single dose of IV Ketamine can rapidly improve     Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with     a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response     Prevention (EX/RP). You will be compensated for your time and travel. Participants must be     between the ages of 18-55.   "
93468|NCT02062645|"     The population that will be included in this study, will be regular Turkish hypertensive     patients who are expected to consume sodium in high amounts. It is hypothesized that, in that     population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP)     control rate as expected from literature.   "
93469|NCT02062632|"     This randomized pilot clinical trial studies the effects of taking doxepin hydrochloride as     compared to placebo (inactive drug) in treating esophageal pain in patients with cancer     located in the chest area receiving radiation therapy to the thorax with or without     chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently     shown to be helpful for mouth pain in patients receiving radiation therapy. Doxepin     hydrochloride affects the surface of the esophagus, which may be helpful in reducing the pain     caused by radiation therapy.   "
93470|NCT02062619|"     Central alexia is a common reading disorder caused by stroke. Patients with central alexia     (CA) are slow to read and make frequent errors, and have additional problems with their     spoken language.      This study has 3 aims:        1. Investigating the neural networks that support reading in patients with CA Despite being          a relatively common syndrome, there have been no functional brain imaging studies of CA.          This project will use magnetic resonance imaging (MRI) and magnetoencephalography (MEG)          to understand which brain regions are damaged and whether preserved parts of the reading          network can be encouraged by therapy to support reading recovery.        2. Testing a new treatment for CA The research team has developed training software called          'iReadMore', which uses a crossmodal approach (written words paired with spoken words)          to train reading. This therapy has been shown to be effective in patients with a similar          form of reading disorder called pure alexia. The iReadMore software will be adapted to          address the reading deficit in CA, and the research will test whether it significantly          improves reading ability.        3. Using brain stimulation to enhance behavioural training Transcranial direct current          stimulation (tDCS) is a brain stimulation technique that has been shown to improve          language performance in healthy controls and stroke patients. This study will test          whether tDCS (delivered simultaneously with the 'iReadMore' therapy) significantly          enhances reading rehabilitation. Patients will be split into two groups: one will          receive a 4 week block of training plus real tDCS first, followed by a 4 week block of          training plus sham tDCS; the other group will receive the two therapy blocks in the          opposite order. Both groups will ultimately receive the same amount of behavioural          therapy and tDCS stimulation. Comparing the reading improvement over the real and sham          tDCS blocks will demonstrate whether tDCS enhances the behavioural improvements in          reading ability.      Hypothesis:      iReadMore reading therapy will significantly improve single word reading speed in patients     with central alexia.      tDCS brain stimulation will significantly enhance the effect of iReadMore therapy, compared     to sham stimulation.   "
93471|NCT02062606|"     To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction     demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as     compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the     treatment of Adolescent Idiopathic Scoliosis (AIS).   "
93472|NCT02062593|"     In this study the investigators will use careful scientific blinding of patient and their     subsequent healthcare staff so that the investigators can determine exactly how much     difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6     weeks blinded phase, all patients will be unblinded and the patients who had undergone sham     procedure will be offered the active therapy.   "
93473|NCT02062580|"     In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected     children develop AIDS and die faster in SSA than those in developed countries. Bacille     Calmette-Guerin (BCG) vaccine is given to infants at birth in SSA to protect them from severe     forms of TB. BCG is known to cause immune cells to be active and replicate faster. The immune     system of neonates also responds differently to BCG that to other vaccines and infections. We     hypothesize that the routine immunization of neonates with BCG contributes to generalized     immune activation in HIV-exposed infants resulting in skewed immune responses to vaccines and     infections and increased rates of disease progression in those infants that become     HIV-infected. However, delaying BCG until HIV testing is completed would result in     operational difficulties, and may not induce the appropriate immune response. Delayed BCG     would also render many HIV-exposed uninfected infants at high risk for disseminated TB. We     plan to assess immune cells in infants to determine the impact of the timing of BCG     vaccination on immune responses to tuberculosis (TB) and other vaccines. We will also compare     the immune activation and disease progression of those infants that become HIV-infected in     the BCG or control arms. Our results will provide key insights into the effect of BCG     vaccination on immune responses to HIV as well as inform the optimal timing of BCG     vaccination for HIV-exposed infants.   "
93474|NCT02062567|"     With this project the investigators wish to:        1. Test the reproducibility of Amlang's ultrasound classification by examining the intra-          and inter-rater reliability.        2. Investigate whether Amlang's ultrasound classification is able to predict which patients          are likely to develop complications when treated non-operatively.        3. Investigate whether Barfod's length measurement is able to predict which patients are          likely to develop complications when treated non-operatively.   "
93475|NCT02062554|"     BHS is a cohort study of consecutive myocardial infarction (MI) patients admitted within the     first 24 hours of symptoms and has been ongoing since May of 2006. The purpose of this study     is to assess for possible markers for increased risk after MI.   "
93476|NCT02062541|"     Background: Illness and hospitalisation, even of short duration, pose separate risks for     permanently reduced functional performance in elderly medical patients. Functional assessment     in the acute pathway will ensure early detection of declining performance and form the basis     for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results     rehabilitation should begin immediately after discharge.      The aim of this study is to investigate the effect of a systematic functional assessment in     the emergency departments (ED) of elderly medical patients with reduced functional     performance when combined with immediate post-discharge rehabilitation.      Method/design: The study is a two-way factorial randomised clinical trial. Participants will     be recruited among patients admitted to the ED who are above 65 years of age with reduced     functional performance. Patients will be randomly assigned to one of four groups: 1)     functional assessment and immediate rehabilitation; 2) functional assessment and usual     rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and     usual rehabilitation.      Primary outcome: 30-second chair-stand test administered at admission and two weeks after     discharge.      We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in     sustained or improved performance in comparison to regimen in which neither of these     interventions are offered.   "
93477|NCT02062528|"     The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes     frequency.   "
93478|NCT02062515|"     The purpose of this study is to determine whether Icotinib is efficient and safe in treating     advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.   "
93479|NCT02062502|"     This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella     Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™     2007 process. The primary hypotheses being tested are that antibody response rate and mean     antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior     to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by     VARIVAX™ NSP is acceptable.   "
93480|NCT02062489|"     The current study is a multicentre, randomized,double-blind, prospective clinical trial     stratified patients by the HER2 status of their cancer (negative or positive) which is     sponsored by the researchers. The trial is designed to evaluate the effectiveness of     tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer     patients. 688 female ER(ER-α)/PR negative, ER-β(wild type ER-β1) positive operable breast     cancer patients who had undergone neoadjuvant chemotherapy or directly modified radical     mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive tamoxifen (20     mg per day) or placebo (2# per day) within 6 weeks after postoperative chemotherapy and/or     radiation therapy if needed (according to 2013 NCCN breast cancer guideline). If the breast     tumor's HER2 is positive, the patient can receive targeted therapy (Herceptin) combined with     tamoxifen or placebo. The follow-up time will be eight years. The aim of this trial is to     evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β     positive operable breast cancer patients by comparing the DFS and OS between tamoxifen group     and placebo group and to determine whether the percentage of positive ER-β expression is     associated with the response to the hormone therapy in breast cancer.   "
93481|NCT02062476|"     Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic     disorders. We have shown that Nutramigen LGG accelerates tolerance acquisition in infants     with cow's milk allergy (CMA). The mechanisms of these effects are still largely undefined.     The effect of LGG could be related at least in part by the immunoregulatory role played by     LGG. This probiotic can balance the generation of cytokines possibly involved in IgE- or     non-IgE-mediated CMA (i.e., IL-4, IL-5, IL-10, IFN-γ , TGF-beta, and TNF-alfa), which can     contribute to modulation of inﬂammatory processes. We have demonstrated that children with     IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's     milk protein, and that tolerance is associated with a marked reduction of IL-13 production     and a concomitant increased frequency of IFN-γ releasing cells.      Epigenetics studies the heritable (and potentially reversible) changes of the genome     inherited from one cell generation to the next which alter gene expression but do not involve     changes in primary DNA sequences, highlighting the complexity of the inter-relationship     between genetics and nutrition. There are three distinct, but closely interacting, epigenetic     mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are     responsible for modifying the expression of critical genes associated with physiologic and     pathologic processes. The profile of epigenetic modifications associated with Th lineage     commitment, coupled with the sensitivity of the early developmental period, has led to     speculation that factors that disrupt these pathways may increase the risk of allergic     diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase     inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour     Th2-associated allergic differentiation. MicroRNAs are another structural components of an     epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has     been recently identified a specific Th2-associated miRNA (miR-21) that is critical for the     regulation of Th cell polarization.   "
93482|NCT02062463|"     This study is conducted to assess whether training participants on proper use of BF SPIROMAX     and Symbicort TURBOHALER will improve their device-handling technique and potentially improve     their treatment outcome, ie, better asthma control.   "
93483|NCT02062450|"     The purpose of this study is to demonstrate the performance and reliability of Tornier Dual     Mobility Cup used during primary total hip replacement or hip replacement revision surgery     at least 24 months post-insertion.   "
93484|NCT02062437|"     The aim of this study is to assess safety and general performance of total hip arthroplasty,     composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction     pair Biolox® Delta Ceramic.   "
93485|NCT02062424|"     The objective of this study is to test the effect of substitution dietary guidelines that are     specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in     the general Danish population.   "
93486|NCT02062411|"     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is     effective in the treatment of attention deficit and emotional, executive function and social     function dysregulation due to attention deficit disorder (ADHD).   "
93487|NCT02062398|"     The current study will evaluate the safety and performance of the BlueWind Medical Reprieve     System for the treatment of Chronic Painful Peripheral Neuropathy.   "
93522|NCT02061943|"     This is a study of patients with spasmodic dysphonia to determine how best to measure the     severity of the disorder in patients. It addresses which characteristics of speech are the     best indicator of whether or not a particular treatment has benefited a person with spasmodic     dysphonia. We hope to recruit 20 participants each at 2 different centers. The evaluation for     each participant will be done on a two visits, one just before and another several weeks     after treatment.   "
93488|NCT02062385|"     This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of     RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks     and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be     enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also     receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus     vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either     staggered or concomitantly with V260 or placebo. All participants will be followed for     efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of     participants. The primary hypothesis of the study states that V260 will be efficacious in     preventing any severity of rotavirus gastroenteritis as compared with placebo.   "
93489|NCT02062372|"     Currently, patients with a glioblastoma multiforme (GBM) are treated with a combination of     different therapeutic modalities including resection, concurrent chemo- and radiotherapy and     adjuvant temozolomide. However, survival is still poor and most of these tumours recur within     one to two years within the previously irradiated target volume.      The radiation target volume encompasses both the contrast-enhanced lesion on T1-weighted     magnetic resonance imaging (MRI), plus a 1.5 - 2 cm isotropic margin in order to include     microscopic speculated growth. These margins result in a high dose to surrounding healthy     appearing brain tissue. Moreover, the short progression-free survival indicates a possible     geographical miss. There is a clear need for novel imaging techniques in order to better     determine the degree of tumour extent at the time of treatment and to minimize the dose to     healthy brain tissue.      The development of Ultra-High Field (UHF) MRI at a magnetic field strength of 7 Tesla (T)     provides an increased ability to detect, quantify and monitor tumour activity and determine     post-treatment effects on the normal brain tissue as a result of a higher resolution, greater     coverage and shorter scan times compared to 1.5 T and 3 T images. Up to now, only few     investigators have examined the use of UHF MRI in patients with malignant brain tumours.     These studies show its potential to assess tumour microvasculature and post-radiation effects     such as microhaemorrhages.      This study analyzes the accuracy of the 7T MRI in identifying the gross tumour volume (GTV)     in patients with an untreated GBM by comparing biopsy results to 7T images. These biopsies     will be taken from suspected regions of GBM based on 7T MRI that do not appear as such on 3T     MRI. We hypothesize that with the 7T MRI the GTV can be more accurately and extensively     identified when compared to the 3T MRI.   "
93490|NCT02062359|"     Background:      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for     treating patients with melanoma that involves taking white blood cells from the patient,     growing them in the laboratory in large numbers, genetically modifying them, and then giving     the cells back to the patient. In a previous study, the NCI Surgery Branch used the     anti-ESO-1 gene and a type of virus (retrovirus) to make these tumor-fighting cells     (anti-ESO-1 cells). About half of the patients who received this treatment experienced     shrinking of their tumors. In this study, we are using a slightly different method of     producing the anti-ESO-1 cells selected for a specific cell type, which we hope, will be     better in making the tumors shrink.      Objectives:      The purpose of this study is to see if these tumor fighting cells (genetically modified     cells) that express the receptor for the ESO-1 molecule on their surface can cause melanoma     tumors to shrink and to see if this treatment is safe.      Eligibility:      -Adults 18 and older with cancer that has the ESO-1 molecule on tumor surfaces      Design:        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of          Health (NIH) clinical Center and undergo a history and physical examination, scans,          x-rays, lab tests, and other tests as needed        -  Leukapheresis: If the patients meet all of the requirements for the study they will          undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells.          {Leukapheresis is a common procedure, which removes only the white blood cells from the          patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the anti-ESO 1 cells and aldesleukin. They will stay          in the hospital for about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits take up to 2 days.   "
93491|NCT02062346|"     Patients with vasculitis commonly develop high blood pressure (hypertension) and this is     associated with an increased risk of heart disease. It is thus important to lower blood     pressure in those with hypertension. However, hypertension in vasculitis is inadequately     controlled with many currently available blood pressure lowering agents.      Endothelin is a chemical produced by blood vessels that contributes to the development of     hypertension. Higher than normal levels of endothelin are seen in patients with vasculitis.     By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the     investigators can hopefully treat hypertension in patients with vasculitis. The purpose of     the study is to ascertain whether endothelin receptor antagonists lower blood pressure and     improve blood vessel function more effectively in patients with vasculitis than those without     it.   "
93492|NCT02062333|"     The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on     Stapes Reflex and Distortion Product Auto Acoustic Emission.   "
93493|NCT02062320|"     The aim of this study is to compare the efficacy of analgesic methods after Caesarean Section     before and after Post Caesarean Acute Pain Service establishing.   "
93494|NCT02062307|"     The aim of this study is to investigate the markers of bone mineral metabolism in an     unconfounded group of patients with hypogonadism and to search for a relationship between     endothelial dysfunction and insulin resistance.   "
93495|NCT02062294|"     This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in     preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from     eligible patients will be collected for the 6 months following transplantation.   "
93496|NCT02062281|"     The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children     and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs),     meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in     China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children     and adults. The main objective of this study is to show that both vaccines can safely be     administered together without affecting the immune response of protecting against disease.   "
93497|NCT02062268|"     Conduct a KAP survey before and after intervention and describe the current knowledge,     attitudes and behaviors on drink driving in public and analyse the influential factors to     provide rational strategies to enhance the awareness on drink driving in public.   "
93498|NCT02062255|"     Obesity promotes worse outcome for post-menopausal breast cancer patients.   "
93499|NCT02062242|"     The purpose of this study is to evaluate the effectiveness of transvaginal electrical     stimulation, vaginal palpation, and vaginal palpation associated with posterior pelvic tilt     and contraction of accessory muscles in the acquisition of ability to contract the pelvic     floor muscles (PFM), as well as to evaluate the sexual function of women studied.   "
93523|NCT02061930|"     The aim of this study is to review the long-term soft tissue stability and the long-term     esthetic results of single crowns supported by tissue level implants placed in non-augmented     healed sites.      The hypothesis of the present study is that tissue level implants can achieve ideal esthetic     outcomes in non-augmented healed sites.   "
93500|NCT02062229|"     Infertility is a common problem, affecting perhaps one couple in six, the majority of whom     now seek medical care. It is becoming a social challenge because it is responsible for     personal and interpersonal discomfort and anxiety. A major obstacle to meaningful study of     the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence     or absence of a problem. Traditionally, the diagnosis of male infertility is facilitated by     the conventional assessment of the semen profile - constructed according to recognized     guidelines (i.e. WHO) and including pH, cell count and motility - but no specific biomarkers     are available.      We sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid     biomarker useful for the diagnosis of male infertility.   "
93501|NCT02062216|"     The primary objective of this study is to assess whether inflammatory receptors play a role     in the pathogenesis of atherosclerosis.   "
93502|NCT02062203|"     The main purpose of this study is to evaluate the effect of single oral therapeutic and     supratherapeutic doses of AKB-6548 on the QT interval.   "
93503|NCT02062190|"     Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters     in patients with schizophrenia taking antipsychotics?   "
93504|NCT02062177|"     Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for     gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for     providing optimal sedation regimen and avoiding under or oversedation. The objective of the     study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus     propofol NAPS.   "
93505|NCT02062164|"     The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery     is the only effective treatment to achieve sustained weight loss in adults with extreme     obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric     surgery is equally effective; however, due to the paucity of long-term data, the long-term     effects and risks are unknown. Thus, due to surgical risk and ethical implications, bariatric     surgery is considered experimental in Germany. Nevertheless, case volumes are increasing.      The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery     in the context of a structured preparation and follow-up program. The study is a subproject     of the study Medical and psychosocial implications of adolescent extreme obesity -     acceptance and effects of structured care (DRKS00004172). At 5 German university centers     (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are     participants in the overall project will be enrolled in a structured preparation and     follow-up program. The program is designed to improve adherence and compliance and will     result in comprehensive follow-up data. In addition to the data gathered in the overall     project, subjects participating in subproject 3 will undergo assessments pertinent to     bariatric surgery, as proposed in the American Teen-LABS study     (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison     will be made with BMI matched adolescents who participate in the overall project but do not     undergo bariatric surgery.      In November 2014 recruitment for the overall project was completed. However, patients     interested in bariatric surgery will still be recruited until September 2016. There     assessment will be the same as for patients recruited earlier. However, in an amendment in     December 2014, the frequency of assessment via questionnaire was reduced from biannually to     annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.   "
93506|NCT02062151|"     This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants     who require pharmacologic therapy at Tampa General Hospital (TGH). We intend to evaluate     acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and     methodological issues. We plan to also test and generate hypotheses in preparation to apply     for funding a larger randomized controlled trial.   "
93507|NCT02062138|"     The purpose of the study is to determine the effectiveness of new interventional approaches     in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that     active training programs are more effective in improving physical function than the passive     standard-of-care therapy.   "
93508|NCT02062125|"     This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how     common and if there are any risk factors for having calcinosis      2) to identify common complications associated with scleroderma-related calcinosis.   "
93509|NCT02062112|"     The purpose of this study is to determine whether the pattern of flavoring and drinking of     laxatives for colonoscopy can improve the experience of patients when they are undergoing     bowel preparation for the test.      Investigators hypothesize that patients will have a better experience if patients taste the     bowel preparation laxative with and without flavoring and then decide how they want to drink     the rest of the laxative since taste preferences vary widely from person to person.   "
93510|NCT02062099|"     Alzheimer's disease (AD) is the most common cause of dementia in elderly subjects. AD is     characterized by brain lesions like extracellular deposits of ß-amyloïd proteins in senile     plaques and intracellular neurofibrillary tangles of hyper-phosphorylated tau protein, both     of which are associated with the loss of neurons. The development of disease biomarkers for     AD (Tau, PhTau and βamyloid dosing in the cerebrospinal fluid, brain MRI, amyloid PET imaging     and fluorodeoxyglucose PET imaging) to identify the pathophysiological processes underlying     cognitive impairment biomarkers, have been incorporated into revised diagnosis guidelines.      Post-mortem human AD and AD animal model studies have reported inflammatory processes also     implicated in the neuropathology of AD, and upregulated levels of pro-inflammatory cytokines.      In vivo visualization of microglial activation has become possible with the development of     molecular imaging ligands (tracers) for use with positron emission tomography (PET). The     translocator protein (TSPO) formerly known as the peripheral benzodiazepine receptor (PBR), a     receptor located in the outer membrane of mitochondria, is upregulated during     neuroinflammation. So targeting TSPO with radiolabeled ligands for PET is considered as an     attractive biomarker for neuroinflammation.      The main aim of this pilot study is to quantify neuroinflammation, in terms of fixation and     distribution of [18F] DPA-714(Binding Potential BP), and to study its relationship with     amyloid load, measured with in [18F]AV-45 (Standard Uptake Values ratio) in cognitive     decline.   "
93511|NCT02062086|"     Current methods for the quantification of muscle mass are indirect, lack precision, and often     rely on expensive equipment that only provides limited (indirect) data on whole body muscle     mass. Dual energy X ray absorptiometry has emerged as a potential precise measure of lean     mass, easy to use in clinical practice and research. However, it assesses an indirect     measurement of total-body skeletal muscle mass and its clinical use for determination of     changes in muscle mass may be very limited due to instrumentation availability, particularly     in field studies, and cost. Moreover, these methods provide estimates of fat free mass that     is not skeletal muscle specific, and are influenced by changes in regional or total body     water content.      GlaxoSmithKline (GSK) has developed a novel technique using deuterium labeled creatine     dilution for the estimation of muscle mass and has begun clinical evaluation of this     muscle-measure in healthy young and older adults.   "
93514|NCT02062047|"     The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root     (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine     (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic     subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is     that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic     and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty     diabetic subjects with chronic periodontitis will be divided in the following therapeutic     groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours,     application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution     during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and     irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group:     SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be     evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing     depth, clinical attachment level, bleeding on probing and suppuration. At these same periods,     glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival     biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40     bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid     samples from two shallow and two deep sites will be evaluated for the levels of     cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.   "
93515|NCT02062034|"     The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant     therapy on progression, clinical regression, oxidative stress markers and mitochondrial     dysfunction in non-proliferative diabetic retinopathy.   "
93516|NCT02062021|"     Autoimmune diseases are diseases in which inappropriate immune responses that have the     capability of harming host cells play an important role. Evidence suggests that the presence     of certain autoimmune diseases such as rheumatoid arthritis or systematic lupus erythematosus     increase the risk of cardiovascular disease (CVD). However, this evidence is inconsistent for     autoimmune disorders and no systematic approach has been previously used to study the     relationship between a range of common autoimmune disorders and specific forms of     cardiovascular diseases such as myocardial infarction, intracerebral and subarachnoid     haemorrhage, or venous thrombosis.      The investigators will use linked electronic health records to investigate whether commonly     diagnosed autoimmune disorders are associated with increased risk of CVD development and     whether effects differ in men and women and change with age.   "
93517|NCT02062008|"     The purpose of this study is to understand how simultaneous PET/MR acquisition can provide     novel qualitative and quantitative biomarkers to guide clinical intervention and predict     prognosis of patients with cardiovascular disease.   "
93518|NCT02061995|"     Osteoporosis is a systemic skeletal disease characterized by low bone mass and     microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility     and susceptibility to fracture.      Osteoporosis is one of the most common and debilitating chronic diseases, and a global health     concern with a high prevalence not only in Western countries, but also in Asia and Latin     America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like     bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent.     Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass     and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black     et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of     pharmacological treatments, osteoporosis remains a significant health problem for patients     who do not respond to the available treatments or fail to comply with their regimens.      The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a     proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic     patients who do not respond to pharmacological treatments.   "
93519|NCT02061982|"     Subjects will perform experiments in an at home-setting. The effect of caffeine in coffee     will be tested in subjects with computer tests on attention and alertness. Comparison of the     results with published results from controlled experiments will indicate the effectiveness of     home experiments.   "
93520|NCT02061969|"     This is a study to determine whether glycemic control, as measured by change in HbA1c and     frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and     basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with     poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with     linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that     treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement     in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC     residents with T2D. We will also determine differences in clinical outcome, resource     utilization, and hospitalization costs between LTC residents with T2D treated with     linagliptin and basal and correction insulin. We will compare differences in complications     (infectious and non-infectious, neurological and cardiovascular events), emergency room     visits and hospitalizations between groups during the 6 months of intervention.   "
93521|NCT02061956|"     Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and the third most     frequent cause of death of cancer.Although with the development of medical science, more and     more patients diagnose HCC at early stage, a lot of patients with HCC still continue to     present with multiple tumors or port vein thrombosis. According to AASLD guidelines, these     patients could received transcatheter arterial chemoembolization (TACE) or new agents as     initial treatment. However, the intermediate group comprises a wide spectrum in terms of     liver function and extent of tumour, and this may explain the large differences in survival     reported for individual series.      A simple, pragmatic and reliable prognostic index based on objective measures would be of     value in providing information to patients, for stratifying patients entering clinical trials     and in making meaningful comparisons between series reported in the literature.The aims of     our study were (i) to identify predictors of survival in a cohort of patients undergoing TACE     or TAE for unresectable HCC, (ii) to develop and validate a simple scoring system and (iii)     to compare the new scoring system with the most frequently used prognostic systems for its     ability to separate high- and low-risk patients.   "
93526|NCT02061891|"     The aim of this study is to evaluate if acute invasive coronary evaluation and treatment     conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred,     subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation     myocardial infarction (NSTEMI) Acute coronary syndrome (ACS) Furthermore, in an observational     design the potential clinical benefit of coronary computed tomography angiography (CCTA) to     select patients for invasive investigation and treatment in the two treatment arms (acute vs     deferred) is evaluated.      The following main hypothesis will be tested:        -  Very early invasive coronary investigation improves clinical outcome in patients with          UAP/NSTEMI-ACS        -  CCTA performed before invasive coronary investigation will improve clinical management          of patients with UAP/NSTEMI-ACS   "
93527|NCT02061878|"     The primary objective of this proof of mechanism pilot clinical trial is to determine if the     RXR agonist bexarotene acts in humans to alter the CSF levels of apoE and alter the clearance     of Amyloid-Beta   "
93528|NCT02061865|"     The primary objective of the study is to investigate the safety of intravitreal (IVT)     REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).   "
93529|NCT02061852|"     The purpose of this study is to determine whether the medical device simeox is safe in the     treatment of respiratory diseases, in comparison with traditional physiotherapy.   "
93530|NCT02061839|"     Main objective is to show that a photoprotective sunscreen having a protection against the     visible light is more effective than a sunscreen having the same UVA AND UVB protection but     with a low (weak) protection against the visible, to prevent the relapses of the melasma     during the summertime.   "
93531|NCT02061826|"     The purpose of the study is to establish drug-induced liver injury databases in China, make     criteria for Chinese drug-induced liver injury patients and evaluate the application of     certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.   "
93532|NCT02061813|"     The purpose of the study is to determine the irritation potential of repeat applications of     abametapir lotion on normal skin.   "
93533|NCT02061800|"     The purpose of this study is to learn more about the effects of (classification determinant)     CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and     young adults. CD34+ stem cells are the cells that make all the types of blood cells in the     body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a     kind of white blood cell) against the recipient's body and organs. Study subjects will be     offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a     CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in     order to decrease the risk of acute and chronic GVHD.      This study involves subjects who are diagnosed with a malignant disease, that has either     failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who     will receive a peripheral blood stem cell transplant. A malignant disease includes the     following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast     crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile     Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's     and Non-Hodgkin's).   "
93534|NCT02061787|"     The application of cardiopulmonary exercise testing in assessment outcomes of patients with     pulmonary hypertension.   "
93535|NCT02061774|"     The purpose of this project is to study the effects of preoperative followed by scheduled     intravenous acetaminophen on pain control for 24 hours postoperatively after minimally     invasive 1 or 2 level transforaminal lumbar interbody fusion.   "
93536|NCT02061761|"     The primary objective of this study is to characterize the safety, tolerability and maximum     tolerated dose of BMS-986016 administered alone or in combination with Nivolumab to subjects     with relapsed hematologic malignancies. Co-primary objective is to investigate the     preliminary efficacy of BMS-986016 in combination with nivolumab in subjects with relapsed or     refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffuse Large B Cell lymphoma     (DLBCL)   "
93537|NCT02061748|"     This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct     comparative safety and effectiveness studies of dabigatran and warfarin using real world data     from Humana's health plan operations.   "
93538|NCT02061735|"     A combined set of quantitative skin imaging methods will quantitatively describe the natural     ontogeny and the response to standard treatments over time in patients with infantile     hemangiomas.   "
93539|NCT02061722|"     The aim of this study is to measure the availability of the PDE10A enzyme in Huntington     disease gene expansion carriers (HDGECs) using the recently developed radioligand     [18F]MNI-659. The study will be cross-sectional, examining HDGECs at different stages of the     disease (pre-manifest, stage 1 and stage 2), in comparison with Healthy Controls (HCs). The     HDGECs included in this study will be recruited from the large database of the REGISTRY     (NCT01590589) or ENROLL-HD (NCT01574053) studies.   "
93540|NCT02061709|"     The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at     reducing allergy symptoms in people who suffer from allergy to Ragweed pollen   "
93541|NCT02061696|"     The goal of the research study is to observe the clinical safety, effectiveness and patient     satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and     possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to     standard manual compression.   "
93542|NCT02061683|"     This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure     (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.   "
93543|NCT02061670|"     The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to     subjects suffering from both ragweed allergy and asthma.   "
93544|NCT02061657|"     The aim of this research work is to assess the effect of using single preoperative dose of     rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the     operation and possible operative complications   "
93572|NCT02061293|"     Several lines of evidence suggest that classic hallucinogens such as psilocybin can     facilitate behavior change in addictions such as alcohol dependence. The proposed     investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group)     contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the     context of outpatient alcoholism treatment.   "
93546|NCT02061631|"     Primary Objective:      To evaluate the overall response rate (including complete response and partial response) of     subjects treated with combination therapy docetaxel and cisplatin followed by the     chemoradiotherapy in patients with locally advanced head and neck cancer      Secondary Objective:      To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed     by the chemoradiotherapy in patients with locally advanced head and neck cancer   "
93547|NCT02061618|"     The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a     culturally-sensitive dance intervention is an accepted and effective physical intervention     for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if     Bollywood dance exercise improves diabetes outcomes in South Asian women.   "
93548|NCT02061605|"     The objective of this pilot study will be to obtain a clinical safety and efficacy endpoint     profile of laser tissue welding therapy for sealing the resected kidney surface after     laparoscopic partial nephrectomy required for removal of resectable benign or malignant renal     tumors in 10 patients.   "
93549|NCT02061592|"     To evaluate the clinical performance of daily disposable etafilcon A lenses.   "
93550|NCT02061579|"     The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the     optimal and feasible level of frequency of structured contact needed in a clinical setting     for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity     recommendations long-term.   "
93551|NCT02061566|"     Indoxyl sulfate (IS) is an anionic uremic toxin that is accumulated in the serum of patients     with uremia. In previous study, the investigators successfully induced AKI animal model. IS     enhanced intercellular adhesion molecule-1 (ICAM-1) expression in IL-1β-treated human     umbilical vein endothelial cells (HUVECs) that this may play a critical role in the     progression of AKI. However, the molecular mechanisms of ICAM-1 expression in IS-treated     IL-1β-treated HUVECs need to be elucidated. HUVECs incubated with 0.2 or 1 mM IS for 24 h did     not cause cytotoxicity. The IL-1β-induced ICAM-1 expression in HUVECs was significantly     enhanced by IS pretreatment. Furthermore, the regulation of adhesion molecule expression     involves a complex array of intracellular signaling pathways including mitogen-activated     protein kinase (MAPKs), reactive oxygen species (ROS) and transcriptional factors. A better     understanding of this might provide important insights into the prevention of AKI.   "
93552|NCT02061553|"     This investigation addresses emotional health in community dwelling persons with traumatic     brain injury (TBI). It is designed to test the efficacy of a novel behavioral treatment for     depression and anxiety symptoms. This treatment incorporates principles of Behavioral     Activation (BA), a promising treatment model for depression and anxiety after TBI, and     implementation intentions, a theoretically motivated method to enhance enactment of     goal-relevant behaviors via action planning. To maximize the impact of this intervention over     time, we use the low-cost, widely available technology of SMS, or text messaging, to promote     positive behavior change in accordance with planned goals and intentions. Participants are     randomized 2:1 to a condition using BA-based implementation intentions or to a control     condition in which participants receive SMS messages with self-selected motivational     statements.   "
93553|NCT02061540|"     The study is an open-label study in adults with primary sclerosing cholangitis to evaluate     the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.   "
93554|NCT02061527|"     To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the     setting of breast cancer treatment.   "
93555|NCT02061514|"     -  Major surgery can lead to postoperative disturbances in sleep patterns with subjective          deterioration of sleep quality according to patients' reports as well as objective          alterations of sleep architecture, as recorded by polysomnography        -  Factors implicated in postoperative sleep disturbances include but are not limited to          the severity of the surgical procedure, the neuroendocrine response to surgery,          inadequate treatment of postoperative pain and external factors interfering with sleep,          such as light, noise and therapeutic procedures        -  There are differences in the molecular mechanisms inhalational anesthetics and          intravenous agents affect different brain regions to induce anesthesia. Our hypothesis          is that these differences may also be evident during the postoperative period, affecting          brain functions which are involved in postoperative sleep architecture. So, the aim of          this study will be to assess the effect of two different anesthetic techniques (propofol          versus desflurane) of maintaining general anesthesia in patients subjected to similar          major operations        -  Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI),          regarding preoperative and long term postoperative sleep quality, sleep diaries          regarding early postoperative sleep quality and biochemical markers (cortisol, prolactin          and melatonin) regarding neuroendocrine response to surgery and disturbances in          endogenous circadian secretion associated with sleep   "
93556|NCT02061501|"     Visual cognitive deficits in children are frequent, with an impact on working and daily     activities. Optometric therapy may improve those functions, however few studies have been     performed.      We aim to evaluate the efficacy of such therapy by a comparative study between two groups of     children aged between 5 and 12 after 6 months of rehabilitation.   "
93557|NCT02061488|"     The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle     Point Model Predictive Control : SP-MPC)   "
93558|NCT02061475|"     Venipuncture and intravenous cannulation are the most common painful procedures, especially     for the penitents who must receive large diameter venous catheter before surgery. In present     study we would evaluate the safety and validity of lidocaine patches releasing such pain.   "
93559|NCT02061462|"     The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted     strategy to increase organ supply.   "
93560|NCT02061449|"     This study evaluates the safety and tolerability of the addition of immunostimulatory therapy     consisting of focal radiation with or without the Toll-like receptor (TLR) agonist Poly ICLC     in patients with cutaneous T-cell lymphoma (CTCL) receiving concurrent therapy with the     histone deacetylase inhibitor (HDACI) Romidepsin.   "
94257|NCT02052336|"     Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420     and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.      Secondary Objective(s): To assess the safety of the coadministration of multiple dose of     CJ-12420 and clarithromycin in healthy subjects   "
93561|NCT02061436|"     Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly     being performed in patients with advanced coronary artery disease, but there is limited     information on the techniques utilized and the procedural outcomes. The goal of this     multicenter, investigator initiated registry is to collect information on treatment     strategies and outcomes of consecutive patients undergoing CTO PCI among various     participating centers. The information collected will be used to determine the frequency of     CTO PCI performed at the participating sites and examine the procedural strategies utilized,     and the procedural (both immediate and during follow-up) outcomes.   "
93562|NCT02061423|"     The primary goals of this trial will be to determine the safety and immune activity of HER-2     pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease     post neoadjuvant therapy. Investigators will also explore the possibility of determining     whether circulating tumor cells can be used as surrogate to assess response to vaccination.   "
93563|NCT02061410|"     The purpose of this study is to determine the effects of neuromuscular electrical stimulation     (NMES) on neuromuscular and functional parameters in elderly with knee osteoarthritis.      The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve     healthy status of elderly with knee osteoarthritis.   "
93564|NCT02061397|"     The purpose of this research study is to see if simvastatin can be taken safely in patients     with either LAM or TSC, who are already being treated with everolimus or sirolimus. This is     the first step in looking at simvastatin as a drug that may help patients, by impacting the     growth and survival of cells that make up the lung lesions that cause problems in LAM and TSC     patients. The study also seeks to learn more about how simvastatin works, when given to     patients being treated with everolimus or sirolimus, and to evaluate the safety and any     potential benefit to patients taking this 2-drug combination.      The primary objective of this study is to determine the safety of simvastatin in the     treatment of LAM-S or LAM-TS in patients on a stable (for at least 3 months) dose of     sirolimus or everolimus.      Secondary objectives include:        -  To assess the effect of simvastatin on forced expiratory volume in 1 second (FEV1).        -  To assess the effect of simvastatin on forced vital capacity (FVC).        -  To assess the effect of simvastatin on diffusing lung capacity (DLCO).        -  To assess the effect of simvastatin on vascular endothelial growth factor -D (VEGF-D)          serum levels.        -  To assess the effect of simvastatin with questionnaire- based assessments of dyspnea,          fatigue, and quality of life (QOL).        -  Assess signs of clinical benefit.   "
93565|NCT02061384|"     Men with infertility and normal hormone levels have few options for fertility treatment.     Previous research work has suggested that men with infertility may have low levels of the     active form of Vitamin A, called retinoic acid, in their testes. We think that giving men     with low sperm counts retinoic acid may increase their sperm counts and improve their chances     of fathering a pregnancy. We want to see if retinoic acid administration over twenty weeks     can increase sperm production and help infertile men become fathers without the need for In     vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). We also want to see     if adding calcitriol with retinoic acid will improve sperm motility in a sub-set of subjects.   "
93566|NCT02061371|"     Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic     muscles of patients with sequelae of stroke.   "
93567|NCT02061358|"     The objective is to evaluate the safety and tolerability of a single-ascending oral dose of     UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption     and elimination following a single dose of UV-4B in healthy subjects.   "
93568|NCT02061345|"     Mild cognitive impairment (MCI) with ageing is thought in part to be related to reduced serum     sex hormones which is well-recognized, especially in females, but poorly understood.     International studies assessing hormone replacement therapy (HRT) to prevent/reduce MCI are     ongoing. MCI leads to morbidity, reduced quality of life and substantial healthcare costs.     The commonest therapeutically induced reduction in sex hormone level in men is treatment of     prostate cancer (PCa). PCa is androgen dependent and androgen deprivation therapy (ADT)     suppressing testosterone to castrate levels is key therapy for advanced disease. About one     million men worldwide have received ADT for PCa, mostly using luteinising hormone releasing     hormone agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps     4% of Caucasians may be castrated. MCI as a side effect of castration in men remains poorly     researched. This study aims to demonstrate that pathological changes occur in the brains of a     significant proportion of prostate cancer patients subjected to ADT that correlate with MCI     symptoms. Highlighting the pathological changes of MCI should improve understanding and     interventions for slowing/preventing MCI in PCa survivors. Brain scans employing positron     emission tomography (PET) imaging technique will be used to detect the presence of     pathological changes in the brain that relate to ADT induced MCI. MCI will be assessed by     neuropsychological assessments (standard paper-based questionnaires and online) and its     neural basis will be investigated using magnetic resonance imaging (MRI).   "
93569|NCT02061332|"     Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by     intranodal, intralesional, or both routes of administration. The primary objective will be     safety and administration with secondary objectives of immune activation and clinical     response.   "
93570|NCT02061319|"     The main purpose of our project is to see if a 12-week program of Nordic walking is better     than standard exercise therapy for increasing exercise capacity (measured by how far people     can walk in 6 minutes) and increasing quality of life (measured by having people fill out two     questionnaires). We will also see if Nordic walking: improves heart performance (measured by     heart ultrasound); improves how active people are (measured by an activity monitor);     increases aerobic fitness (measured by a treadmill test); improves body composition (measured     by waist size); and reduces hormone levels in the blood.   "
93571|NCT02061306|"     Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in     wheat, rye, and barley. It is well known that many factors contribute to the development of     CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we     will consider as many of these factors as possible and study how they each contribute to     disease development. If the investigators find that any one factor, or combination of     factors, increases the risk of developing CD, we will be able to apply this information and     help prevent or detect disease in high-risk children in the future.   "
93573|NCT02061280|"     Asthma is an inflammatory disease that imposes a significant burden affecting an estimated     300 million persons and 20% of all children worldwide. It is one of the most common chronic     diseases of childhood and is a leading cause of school absenteeism. There continues to be a     great need for clinical trials in asthma but traditional clinical trials are expensive and     reasons cited by patients for non-participation are extra inconvenience and logistical     barriers. Study designs which are patient centered and reduce trial costs are needed. The     long-range goal of this application is to transform the paradigm of clinical research into a     more efficient and cost-effective enterprise by capitalizing upon current widely used mobile     electronic means of communication and information transfer.      This innovative project is a streamlined clinical trial that will run concurrently with a     nearly identical traditional clinical trial, Long-acting Beta Agonist Step Down Study     (LASST) which will allow for direct comparison of processes and outcomes between the     streamlined and traditional approach. Children 12 to 17 years old with asthma will be     randomized to participate in this project (streamlined trial) or LASST (traditional trial).     In this proposal we will: measure comprehension of study information using an original     questionnaire, Research Participant Assessment (developed at Nemours), following a parental     permission/assent process delivered over the internet in a dynamic interactive multi-media     format (Specific Aim 1); measure the efficiency of participant driven data entry from home     into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality     of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad     (Specific Aim 2); test whether the streamlined approach has a trial effect by comparing the     differences in Asthma Control Test (ACT) scores following 12 weeks of study drug treatment in     children randomized to this project compared to LASST. We will collect effort reporting data     to compare personnel costs between the trials. If this streamlined project lacks a trial     effect and reduces costs compared to LASST, the methodologies would be generalizable to     studies which include adults and other diseases.   "
93574|NCT02061267|"     The metabolic syndrome may be defined as the constellation of cardiovascular disease (CVD)     risk factors that comprises obesity, type 2 diabetes, dyslipidemia, and hypertension. Lack of     habitual physical activity and certain dietary patterns, including high-saturated fatty acids     (SFA) intake, contribute to increase the risk of CVD, whereas the greatest risk reduction is     related with monounsaturated fatty acids (MUFA), mainly from olive oil, and omega-3     polyunsaturated fatty acids (PUFA). Vitamin B3, as a major substrate for nicotinamide     phosphoribosyltransferase (NAMPT), has also emerged as a nutritional intervention strategy     for prevention of CVD.      NAMPT has been shown to exert activities of central importance to cellular energetics and     innate immunity. Within the cell, NAMPT is the rate-limiting step in a salvage pathway of     nicotinamide adenine dinucleotide (NAD+) biosynthesis. By virtue of this role, it can     regulate cellular levels of NAD+ and thereby NAD+-consuming enzymes. NAMPT is also released     by a variety of cells, and elevated levels can be found in the systemic circulation of     subjects with a range of inflammatory disorders.      Recent evidences suggest that, primarily due to its high MUFA content, olive oil is useful as     an optimal fat for the modulation of CVD risk factors in the postprandial state. In addition,     NAMPT has been shown to correlate with triglycerides in the fasting plasma, and a potential     regulatory role for fatty acids on NAMPT expression has been proposed.      The global aim of the project is to assess whether olive oil (MUFA), compared to other     dietary fatty acids (SFA and omega-3 PUFA) and in association with vitamin B3 could have     benefits on NAMPT-related inflammation and atherosclerosis. We hope to provide important     novel insights on the relationship among dietary fatty acids, NAD+ metabolism, and metabolic     syndrome. This aim is expected to be achieved in one principal objective:      To elucidate the influence of olive oil (MUFA), butter (SFA) or fish oil (omega-3 PUFA) meals     supplemented by vitamin B3 on postprandial NAMPT modulation and its involvement on leukocyte     inflammatory response in subjects with metabolic syndrome.   "
93575|NCT02061254|"     Explorative study on a medical device with two steps. The first pilot step will be on 8     patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess     the feasibility of measures by high resolution transient elastography on these pathologic     skins, and to define 3 areas for measures.      The second step will be on 136 participants (48 healthy volunteers, 48 with venous     insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to     quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous     fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy     skin.   "
93576|NCT02061241|"     Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as     an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond,     with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders     has become the key research focus in CRT.      Targeting the position of the left ventricular (LV) pacing lead within the coronary vein     network has previously been shown to increase the proportion of responders to CRT. Several     techniques have been tried for targeting lead position, of which the best investigated are     the use of speckle-tracking echocardiography to target the lead position to the site of     latest mechanical activation of the left ventricle, and the use of invasive monitoring to     select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP     occurs. Both techniques are limited by groups of patients in whom the techniques are not     possible or provide limited useful information.      The relationship between these two measures is unknown - there are no previous studies that     have investigated correlation between the site of latest mechanical activation determined by     echo and the site of maximal AHR. It is likely that a hybrid technique using both of these     investigations might allow optimal lead positioning in more patients, or that if the     information is shown to be equivalent, more streamlined techniques can be designed.      This study will also be able to contribute towards several important secondary questions. In     particular the investigators will study the possibility of using non-invasive cardiac output     monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure     monitor wire. The investigators also wish to assess whether the site of latest mechanical     activation is changed by right ventricular pacing.   "
93577|NCT02061228|"     A randomised controlled open-label clinical trial to assess the effect of artificially     induced endometrial injury and repair during ovarian stimulation on the clinical pregnancy     rate of an antagonist downregulated in-vitro fertilisation cycle   "
93578|NCT02061215|"     Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions     and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal     transplant recipients who are CMV seropositive (regardless of donor serology). Viral load     measurements will be performed at baseline prior to transplant (within 1 week),and then at 3,     7 and 10 months after transplant. It is expected that the patient will receive anti-CMV     prophylaxis until 6 months post-transplant, so the latter two time points will reflect     responses after release from antiviral suppression. Each patient will serve as their own     control, with comparisons made between measurements at baseline and then at each timepoint.      Blood from 10 patients in each age group will be studied, to collect virologic and immune     response data:        -  CYTOF (broad array of measurements)        -  Tetramer assays (requires recipient HLA type of A1, A2, B7)        -  CMV viral load PCR        -  Response to pneumococcal antigens and inactivated influenza virus      In addition, clinical data will be collected at the time points indicated,particularly renal     function and the presence/absence of acute rejection.   "
93644|NCT02060357|"     The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity     Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting     stent (Boston Scientific), in patients with diabetes.      We plan to compare endothelial coverage and neointimal proliferation using OCT and compare     this data to published results from conventional stents.   "
93691|NCT02059746|"     This is an ancillary study to the JUMODA (National Prospective and Comparative Study on the     Mode of Delivery of Twins) study: please see NCT01987063.      The main objective of this study is to investigate the role of the mode of delivery (vaginal     versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months     post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.   "
93579|NCT02061202|"     The proposed research is designed to test the global hypothesis that inhaled corticosteroids     (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in     adults with SCD who wheeze, but do not meet criteria for a diagnosis of asthma. The specific     aims of this proposal are 1) Conduct a feasibility study - a randomized controlled trial of     ICS for adults with SCD who do not meet criteria for a diagnosis of asthma but report     recurrent cough or wheezing, 2) Measure the effects of ICS on biological correlates of     pulmonary inflammation (as determined by exhaled nitric oxide) and vascular injury (as     determined by sVCAM) in SCD, and 3) Compare properties of traditional and Bayesian adaptive     clinical trial design for therapeutic trials in SCD in preparation for designing a definitive     trial of ICS. These aims have the potential to 1) change the standard of care for individuals     with SCD and recurrent cough or wheeze, 2) provide insight into the pathogenesis of     non-asthmatic wheezing in SCD and its response to treatment, 3) explore the suitability of     innovative clinical trial designs to overcome the challenges that have hindered therapeutic     innovation for SCD.   "
93580|NCT02061189|"     This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3     Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific     exercise should promote motor skills of trained patients, as we have observed in different     mouse models. Patient's motor skills will be assessed using different scales including MFM     and Hammersmith.      This clinical trial attempts to develop a new non-invasive motor scale with sophisticated     instruments.      This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of     currently available scales.      In addition, the study attempts to validate a questionnaire on post-exercise physical     well-being.   "
93581|NCT02061176|"     A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open     Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the     study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.      Secondary endpoints are postoperative pain, complications, effect on anal continence,     recovery and return to normal activity, quality of life and health cost analysis.   "
93582|NCT02061163|"     To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can     accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's     disease.   "
93583|NCT02061150|"     Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict     criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS)     sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are     asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due     to risk factors alone, to determine the number of newborns having positive blood cultures,     and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.   "
93584|NCT02061137|"     The Trial Objective is to assess safety and efficacy of oral fingolimod (FTY720) in children     older than 6 years with Rett Syndrome. So far there is no established treatment for children     with Rett Syndrome. Therefore a positive result in terms of safety and first indications of     efficacy would path the way to a phase II clinical study with more patients to further test     the hypothesis that fingolimod treatment may slow down the regression of motor and language     skills.   "
93585|NCT02061124|"     Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute     essential components in the complex mechanisms regulating gut hormone secretion and glucose     homeostasis. At the same time, bile acids and gut bacteria are interdependent. Thus, it is     likely that modification of the enterohepatic circulation of bile acids can lead to changes     in gut hormone secretion or gut bacteria composition and consequently affect glucose     homeostasis.      The current study is a human interventional study with 7-day ingestion of a bile acid     sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is     to examine how (and if) bile acid sequestration can influence postprandial glucagon-like     peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2     diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a     phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with     chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic     control in patients with chronic kidney disease and type 2 diabetes.      The investigators hypothesize that higher luminal concentrations of bile acids in the distal     gut will elicit changes in the postprandial gut hormone secretion and gut bacteria     composition. The current study will help to clarify this hypothesis and improve our general     understanding of the association between bile acid circulation and signalling, gut hormone     secretion, gut bacteria and glucose metabolism.   "
93586|NCT02061111|"     Previously, studies have shown that children of women with thyroid autoantibodies experience     more birth complications and poorer health in their first days. Studies have also shown later     signs of cognitive developmental challenges (risk of attention deficit/hyperactivity     problems) among children of mothers with autoimmune thyroid disease. In Denmark there is no     formalized screening or treatment of subclinical thyroid disease - with or without Thyroid     Peroxidase Antibodies (TPO-antibodies) - among pregnant women.      The hypothesis of this study is that the offspring of women with subclinical thyroid disease     have a mitochondria-dysfunction which leads to more complications during birth, poorer health     and well-being in the early childhood. The investigators will test this by recruiting mothers     by a blood sample in the third trimester of pregnancy, screen the cord blood at birth and     later on test the children with Bayley test two times in the early childhood.   "
93587|NCT02061098|"     The investigators objective is to carry out a placebo-controlled, dose-response, randomized     clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular     disease risk in overweight adult subjects upon the consumption of pomegranate extract.      The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such     as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory     markers. The correlation between the effect exerted and the subjects' microbiota (capacity to     produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of     urolithins on the effects.   "
93645|NCT02060344|"     The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center     epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in     the prevalence and development of disease, and to identify risk factors playing a protective     or harmful role in Hispanics/Latinos.   "
93588|NCT02061085|"     Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and     tolerability of first line single agent Eribulin in patients with HER2-negative metastatic     breast carcinoma previously exposed to taxanes for early stage.      The primary objective of the study is to determine the median time to progression achieved     with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit     rate, time to treatment progression, duration of response and toxicity profile.   "
93589|NCT02061072|"     The aims of this trials are:        1. to collect published and unpublished individual classic pharmacokinetic data (individual          patient data from independent investigators and pharmaceutical companies)        2. to make available population pharmacokinetic models for the concentrates derived from          the data collected        3. to develop a web based application intended to use the above models to calculate          pharmacokinetic parameters for individual patients, and        4. to test the system functionality via simulation of the use of the prototype by use of          faked test data.   "
93590|NCT02061059|"     The purpose of this study is determine whether the use of plantar pressure measurements in     the production of customized therapeutic footwear for patients with diabetes and a history of     foot ulceration results in lower production costs and more pressure relief, compared to the     standard production. A secondary objective is to explore if a difference in durability can be     observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes     produced with and without plantar pressure measurements.   "
93591|NCT02061046|"     To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea     syndrome.   "
93592|NCT02061033|"     Patients with hemophilia who have the same level of deficient factor(s) may express different     severity of clinical presentation and bleeding tendency. Therefore a test which could     determine overall hemostasis rather than simple concentration of a single deficient factor     may correlate better with clinical phenotype in these patients.      The investigators will therefore study the usefulness of global hemostatic methods     (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot     structure) and microparticles in the prediction of severity of bleeding and estimation of     response to the treatment in patients with hemophilia.      Since hemophilia patients on prophylactic treatment virtually do not bleed, additional     patients who are treated on demand only will be included enabling to study possible     modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin     activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will     correlate both those factors and clinical severity with global hemostatic methods.      The investigators expect to prove that individual tailoring of the treatment, which may     enable lowering the prophylactic dose of factor concentrate without increasing the risk of     bleeding, is justified in some hemophilia patients. This approach would reduce the amount of     necessary factor concentrate in certain patients and decrease the cost (which represents     extensive burden for health care systems) of treatment without potential risk for the     patients.   "
93593|NCT02061020|"     Study of the effects of smoked cannabis consumption on performance on a driving simulator and     reaction time. The study aims to explore the relationship between concentrations of cannabis     in the blood, driving performance and reaction time.   "
93594|NCT02061007|"     The purpose of this study is to determine if magnetic resonance imaging (MRI) or positron     emission tomography (PET) imaging can be used to help doctors determine how much oxygen a     tumor is getting. Hypoxyprobe will be used to determine the levels of oxygen post-surgery in     the current study. If the study is successful, then imaging can be used to determine a     tumor's oxygen status even in patients who are not getting surgery.      Investigators want to find out how much oxygen is in the participants tumor based on how much     pimo is present, and correlate this with the results of their MRI and 18F-fluoromisonidazole     (FMISO) PET scan.      This study is also testing the investigational radioactive substance known as FMISO. FMISO is     used during PET scans to help doctors see how much oxygen a tumor is getting. Participants     might be asked to participate in an optional PET scan using FMISO.   "
93595|NCT02060994|"     Background: It is known that after Cesarean section is correlated with respiratory     complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.      Goal: The aim of the current study is to find out if these respiratory complications extend     to later life.      Methode: Reviewing the patients' medical file, and collecting data about respiratory     complication.   "
93596|NCT02060981|"     Investigators will conduct a randomized trial with patients, through one-on-one interviews,     to evaluate their understanding of and willingness to use a decision support tool and to     determine if receiving and discussing the decision support tool improves the likelihood that     a patient is adherent to a new antihypertensive medication.   "
93597|NCT02060968|"     The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in     Routine Clinical Practice   "
93598|NCT02060955|"     The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in     patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed     by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to     standard Bevacizumab/Irinotecan second line treatments for these patients.   "
93599|NCT02060942|"     Determining fluid responsiveness in critically ill patients by measuring mean systemic     filling pressure on the intensive care unit.   "
93600|NCT02060929|"     The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to     the medication) of intranasally (through the nose) administered esketamine using a device     with and without a nasal guide in healthy participants.   "
93601|NCT02060916|"     This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions     measured via continuous glucose monitoring and its adverse effect profile in humans.   "
93602|NCT02060903|"     The purpose of the study is to assess the efficacy, safety and tolerability of a single     application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the     scalp and hair for 10 minutes at home.   "
93689|NCT02059772|"     The primary objective of this study is to evaluate if a combination therapy with micropulse     diode laser treatment shows non inferiority on visual acuity within 12 months in comparison     to standard therapy (intravitreal injection of ranibizumab only).   "
93603|NCT02060890|"     This current study will use a new treatment approach based on each patient's tumor genomic     profiling consisting of whole genome sequencing, exome analysis, and RNA sequencing as well     as predictive modeling. This new treatment strategy has shown promising results in adult     patients with other solid tumors.      The current study will test the feasibility of a specialized Tumor Board assigning a     treatment plan within 35 calendar days of obtaining tumor tissue. The treatment plan will     take into consideration each patient's tumor molecular profile and predictive modeling as     well as prior history and treatment(s), and other medical conditions of the patient.   "
93604|NCT02060877|"     The purpose of this study is to gain insight in the distress experience and quality of life     of patients suspected of having a serious lung disease during the diagnostic phase and the     period between diagnosis and start of treatment   "
93605|NCT02060864|"     In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten     sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten.     Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal     fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have     completed 3 test days, a blind interim analysis is performed by a third party based on which     it is decided whether to proceed with the low AN-PEP dose.   "
93606|NCT02060851|"     There are wide variations in iron supplementation practices in NICU.Guidelines on paediatric     Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.In our     early study serum ferritin and TIBC were not statistically significant before and after     intervention by used the dose of intravenous iron.In our study,we find twhether iron combined     EPO can improve iron state in preterm.   "
93607|NCT02060838|"     Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease     post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. Blood     is drawn from our patients pre-bypass after obtaining the arterial line and administered back     to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin     with protamine. In our practice we noticed some variability in the impact of ANH on     postoperative bleeding; with some patients appearing to show more hemostasis after separation     from CPB than others. This is a prospective study to find out if there is an optimal time     period that guarantees the largest amount of functioning platelets and what is the best     practice for drawing and storing of ANH to guarantee the largest amount of functioning     platelets.   "
93608|NCT02060825|"     This project is evaluating the validity of regional saturation monitoring in evaluating     changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in     many institutions, including NCH. Advances in the technology and recent approval of the use     of CASMED devices for this purpose will allow us to use this technology more effectively. We     aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and     post operative period for the hybrid procedure and the balloon atrial septostomy procedure     (BAS).   "
93609|NCT02060812|"     Purpose: The purpose of this study is to compare the result of combined sono-guided     suprascapular nerve block (SSNB) and axillary nerve block (ANB) with isolated SSNB in     postoperative pain following arthroscopic rotator cuff repair. Our hypothesis was that SSNB     combined ANB would show a more effective anesthesia for arthroscopic rotator cuff repair as     compared with SSNB only.      Methods: Forty-two patients with rotator cuff tear who had undergone arthroscopic rotator     cuff repair were enrolled in this study. Among them, 21 patients were randomly allocated into     group I, and received SSNB and ANB with each 10mL ropivacaine. The other 21 patients were     allocated into group II, and received SSNB with 10mL ropivacaine and ANB with 10mL normal     saline. Visual Analogue Scale (VAS) pain score, patient's satisfaction (SAT), and Lateral     Pain Index (LPI), etc was checked at postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours.   "
93610|NCT02060799|"     Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing     discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms     patients can experience; and it is one of the main complaints in the patients presenting to     the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac,     pulmonary or metabolic etiologies or a combination of them, since several diseases can cause     dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary     disease (COPD).      Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in     heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure     (HF) is one of the most important causes of morbidity and mortality in the industrialized     world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general     European population. The incidence increases rapidly with age, and in Europe.     Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to     hospital have been adequately described, in Europe and in the United States. The Euro Heart     Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely     hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for     AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively.      This same sensation of breathlessness is what also drives patients with asthma and chronic     obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD)     exacerbation accounts for approximately 1.5 million ED visits in the United States per year.     It is the third most common cause of hospitalization, with an estimated 726 000     hospitalizations in 2000 in the USA. Previous studies have demonstrated important differences     between guideline recommendations and actual management of COPD exacerbation, either in the     ED or during hospitalization.      The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low     sensitivity of the clinical signs associated with the aging of the population and the variety     of underlying diseases. Little is known about the Epidemiology of dyspneic patients in the ED     at the European level. Diagnosis, prevalence and treatment of the patients may vary among     European countries.   "
93611|NCT02060786|"     This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison     with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.   "
93612|NCT02060773|"     To observe the effect of early goal directed therapy (EGDT) on hepatic perfusion in patients     with septic shock.      Hypothesis: Hepatic perfusion did not improved after EGDT in patients with septic shock.   "
93633|NCT02060500|"     Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of     medical therapy, many children are referred for surgical intervention. Techniques have     evolved over the last 50 years; however, benefits in children remain the center of debate in     many surgical forums. This is primarily owing to the high incidence of recurrence of reflux     and need for revisions later in life. Some clinicians theorize that the pathophysiology of     reflux in infants is different from that of the population at large, and that the traditional     operation may not be the best suited for this patient population. We propose a study to test     an alternative plication technique for modifying the gastro-esophageal junction at the Angle     of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve     which will limit reflux without disrupting the diaphragmatic crura, thus reducing the     incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are     too tight.   "
93614|NCT02060747|"     Harrington's metaphorical depiction captures the essence of the problem : Osteoporosis care     of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists,     primary care physicians and osteoporosis experts into which the fracture patient disappears.      The most effective way to achieve this goal is through implementation of coordinator-based     post fracture models of care. Exemplar models have been refered to as Fracture Liaison     Service (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) Osteoporosis Coordinator     Program (Canada [9,10]) or Care Manager Programs (USA [11,12]).      The objective of this trial is to assess efficacy of a new coordinator-based post-fracture     program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after     fracture thanks to an optimal recommendations practice to reduce the incidence of secondary     fractures.      Men and women are included aged over 45 years with fragility wrist and hip fractures.      Evaluation criteria are based on the evidence-based assessment (stratify risk, identify     secondary causes of osteoporosis, fracture evaluation), the medication adherence, others     prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number     of falls.      Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6     months   "
93615|NCT02060734|"     To determine the efficacy of lidocaine injection of trigger points versus subcutaneous     injection in patients with subacute whiplash associated disorder following injury.   "
93616|NCT02060721|"     Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used     for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)   "
93617|NCT02060708|"     Non-invasive human brain stimulation using weak transcranial direct‐current stimulation     (tDCS) has been thousands of times in research studies over the past fifteen years as a     therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises     in the context of daily physiotherapy), due to its safety, tolerability, convenience and     cost‐effectiveness. tDCS works by temporarily enhancing brain activity during performance of     a specific task, helping with learning and training.      The investigators will use magnetoencephalography (MEG) brain imaging to view the real‐time     effects of high definition (HD) tDCS on several brain areas involved in vision, hearing,     movement, and memory. The investigators hypothesize that changing the task (auditory, visual     or memory task) but keeping the position of the electrodes over the motor cortex will result     in modulation of brain activity in only the central target motor area, and not on non-target     temporal, occipital or pre-frontal areas.   "
93618|NCT02060695|"     The purpose of this study is to determine the temporal relationship between motor     fluctuations and non-motor fluctuations in persons with Parkinson's disease.      Observational study case-only   "
93619|NCT02060682|"     This registry will collect real-world clinical evidence on the performance, safety, and     usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved     labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow     Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS     Catheter. All subjects will receive diagnostic treatment according to clinical indications     and center standard practice.   "
93620|NCT02060669|"     Colorectal cancer (CRC) accounts for 10% to 15% of all cancers and is the second leading     cause of cancer deaths in Western countries. Approximately half of all patients develop     metastatic disease and become candidates for the palliative chemotherapy which has been     proved to prolong survival and improve quality of life (QOL) in patients with metastatic CRC.     The most active chemotherapy regiments include oxaliplatin or irinotecan combined with     fluoropyrimidines.      With overall survival in metastatic CRC nowadays routinely around 2 years, the same intensity     of therapy can hardly be maintained throughout the course of therapy. The continuum of care     therefore mandates changes in therapy, with treatment breaks or phases of less-intensive     maintenance therapy interspersed with periods of more-intensive therapy to control tumor     progression. Thereby, chemo-holidays conceivably reduce the cumulative toxicities of     chemotherapy, potentially prevent the unplanned, premature discontinuation of therapy,     preserve the ability to administer further phases of therapy, potentially maximize the time     on therapy, reduce cost, and could increase QOL for patients. Several trials have tested the     influence of chemo-holidays on patient outcome, with various rules on when to stop which     component of antitumor therapy as follows; 1) Completely stopping all therapeutic agents,     giving patients a completely chemotherapy-free interval (OPTIMOX-2, GISCAD), or 2) Stopping     only those agents associated with significant (cumulative) toxicity while continuing other     agents as maintenance therapy (OPTIMOX-1, Combined Oxaliplatin Neurotoxicity Prevention Trial     [CONcePT]).      Therefore, we'd like to test if capecitabine maintenance after 8 cycles of capecitabine     combine with oxaliplatin (XELOX) could prolong progression-free survival without     deterioration of QOL and toxicities in patients metastatic CRC.   "
93621|NCT02060656|"     This is a randomised, phase II open-labelled two-arm study comparing R-GEM-P and LR-GEM in     second-line treatment of Diffuse Large B-cell lymphoma. Eligible patients will be randomised     1:1 between R-GEM-P and LR-GEM.   "
93634|NCT02060487|"     This is a blinded study in adult patients with PAH evaluating the relative effects of     sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three     times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute     walking distance (6MWD) will be assessed.   "
93690|NCT02059759|"     The primary objective is to evaluate in ALS patients the regulatory T cell early response to     two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days     comparatively to placebo.   "
93622|NCT02060643|"     Some patients with head and neck cancer or benign tumours of the head and neck receive     radiotherapy to their neck as part of their treatment. The carotid arteries are often     included in the radiotherapy as collateral structures. There is some evidence to show that     radiotherapy to these blood vessels can result in thickening of the artery walls some years     after treatment and increased risk of stroke or TIA in the future.      Current research is now aimed towards detecting radiotherapy-related changes to the carotid     arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating     these blood vessels if possible. The question of whether or not the use of preventive     medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is     currently unanswered.      The aim of this study is to measure the thickness (intima-medial thickness) of irradiated     carotid artery walls and compare this to unirradiated arteries. There are many other causes     for thickening of arteries (such as high blood pressure, high cholesterol levels and     diabetes) and these may affect the ability to measure the effect of radiotherapy change to     the artery wall. In order to address this, it is ideal to look at this process in patients     who have only had one side of their neck treated and use the other side as a comparison. The     study will also be looking for earlier signs of radiotherapy-related changes, such as     stiffening of the artery wall, inflammation in the artery wall (a very early sign of     radiotherapy-related change) and some markers in the blood that may indicate that this     process is taking place.      The null hypotheses of this study are:        -  In irradiated carotid arteries, the mean intimal-medial thickness will be the same          compared to unirradiated arteries.        -  Serum biomarkers will not be elevated in radiation-induced carotid atherosclerosis.        -  Development of radiation-induced carotid atherosclerosis is not affected by risk factor          modulation (Aspirin, HMGCoA reductase inhibitors, smoking cessation).        -  There is no difference in carotid arterial wall strain in irradiated carotid arteries          versus unirradiated carotid arteries.        -  Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries          as an early marker of atherosclerosis.   "
93623|NCT02060630|"     This study will compare the effectiveness of best available surgical treatment with best     available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible     for both treatment options.   "
93624|NCT02060617|"     Recent research has shown that classifying patients with low back pain into treatment     subgroups results in better improvements than treating all patients with low back pain the     same. However, physical therapists may use different types of information to determine how to     classify their patients. One method uses patient characteristics that have been shown by     research to predict good results from a certain type of treatment. Another method uses     specific impairments that the physical therapist identifies in a clinical exam to determine     which treatment to provide. It is not currently known if one of these methods is better than     the other. The purpose of this study is to determine if research-based classification or     impairment-based treatment is more effective for treating patients with low back pain that     has lasted less than 90 days in terms of improvements in pain and disability. The results of     this study may help reduce the high financial cost associated with low back pain.   "
93625|NCT02060604|"     The addition of an anti-inflammatory agent could be a valid option for controlling choroidal     neovascularization, as simply inhibiting VEGF addresses neither the multifactorial     pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.   "
93626|NCT02060591|"     The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into     account pain control, narcotic consumption, narcotic-related side effects, outcomes measures,     and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis     to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay     and the need for physical therapy postoperatively, therefore, offsetting its higher price in     comparison with Marcaine.   "
93627|NCT02060578|"     Cancer is the second cause of over-one-year-old children mortality after accident. Survival     rate is more than 70%, but in some cases, curative treatments are not sufficient and     palliative support is implemented for those children in end of life.      Pediatric guidelines about the place of end-of-life care are varied. On European scale, home     is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development     program recommended home or initial hospital care unit. This program also supports     implementation of mobile team rather than specific hospital units.      In Brittany, a pattern of regional palliative care resource team has been implemented since     2005. In oncology, further to the guidelines, end-of-life place of care is often discussed     several times for each case. Sometimes occur a lot of returns between home and hospital,     psychological difficulties, and difficulties to offer adapted care conditions. Finally, less     than 30% of children in palliative care decease at home.      The primary objective is to identify main determinants of the place of palliative care in     pediatric oncology.      The secondary objective is to clarify the factors of change comparing to the initial planned     place.      Intervention :      Questionnaire completed by the parents Interview with the parents and the psychologist     (University Rennes 2)      Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative     phase, that means 136 to 186 parents.      Expected results and perspectives :      Using both quantitative and qualitative methods, expected results are the followings:        -  Identification of the objective and subjective factors, which influenced the decision of          the place of care.        -  Determination of the factors of change comparing to the initial planned place.      Once identified, main factors could be the ones to pay attention to in order to help for     initial decision, better anticipation of change of place and better guidance of palliative     care organization wherever, at home or in hospital.      Results would be new information for research on palliative care for children but also for     adults.      Finally, this work is part of an improving approach of palliative care, related to the     development of open-care hospital networks. We can expect some public health impacts with new     arguments to help for complementary recommendations.   "
93628|NCT02060565|"     The aim of this retrospective and prospective study is to evaluate the 20-year prognosis     value of non-invasive methods for the diagnosis of chronic liver disease for predicting     survival and complications of cirrhosis.   "
93629|NCT02060552|"     The aim of study was to assess the efficiency and safety of oral IL-1βinhibitor in     combination with urate lowering therapy on joint pain intensity,urate control, global     assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers     and symptoms improving related life quantity in gouty patients.   "
93630|NCT02060539|"     To obtain subjective and objective feedback on the clinical performance of Biofinity lenses     after at least two weeks daily wear in existing contact lens wearers compared with their     habitual lenses.   "
93631|NCT02060526|"     Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage     disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence     of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate, resulting     in progressive neurodegeneration. Symptoms are usually first noted in the 1st or 2nd year of     life, although definitive diagnosis is often delayed, with an average age of diagnosis of 4.5     years. The disease is characterized by developmental delays initially, followed by     neurological developmental arrest, then regression. These developmental deficits are     typically associated with severe behavioral disturbances. Patients have a significantly     reduced lifespan, with few surviving beyond the 2nd or 3rd decade.      The purpose of this study is to evaluate the safety and efficacy of recombinant human     heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis Type     III A Disease.   "
93632|NCT02060513|"     Military service members and the U.S. veteran population face a growing and serious health     threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling     pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria     are increasing significantly. They cause major complications and mortality, and drive up     healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can     actually pressure bacteria to develop resistance.   "
93635|NCT02060474|"     This therapeutical trial will be conducted in patients with the Allan-Herndon-Dudley Syndrome     (AHDS), which is mutations in MCT8.      MCT8 is a thyroid hormone (TH) transporter which is crucial for the transport of TH from the     blood into different tissues. Dysfunction of MCT8 results in a lack of TH (hypothyroidism) in     tissues that depend on MCT8 for TH uptake. This local hypothyroidism in the brain of these     patients causes severe psychomotor retardation.      In addition, TH serum parameters are highly abnormal in AHDS: high T3, low T4 and normal TSH     levels. The high serum T3 levels cause local hyperthyroidism in tissues that do not depend on     MCT8 for cellular transport of TH, resulting in a low body weight and reduced muscle mass.      Currently, no adequate treatment is available for the AHDS. A T3 analog that does not depend     on MCT8 for its cellular entry could, at least partially, restore the abnormalities found in     AHDS. Several in vivo, in vitro and animal studies have shown that the T3 analog Triac is a     very promising candidate:        1. Triac binds to the same TH receptors as T3;        2. Cellular uptake of Triac does not depend on functional MCT8. Hence, in AHDS patients          Triac will also be available in tissues that require functional MCT8 for TH uptake, e.g.          the brain;        3. In vitro studies have shown that neuronal cells differentiate equally well in the          presence of either Triac or T3;        4. In Mct8 deficient mice, Triac is taken up by the brain and suppresses serum TSH levels;          consequently, serum T3 and T4 levels were lowered;        5. Triac is the treatment of choice in patient with the resistance to thyroid hormone (RTH)          syndrome. Patient with RTH have high serum TSH and thyroid hormone levels, which shows          strong similarities to the profile found in AHDS patients; the longstanding experience          with Triac in RTH indicates its safety and tolerability .      Thus, Triac treatment could result in normalization of the abnormal serum TH values in AHDS     patients. Furthermore, Triac could replace the function of T3 in tissues that depend on MCT8     for TH uptake (e.g. brain).      The current trial will investigate if Triac treatment in ADHS patients        1. reduces the toxic effects of the high T3 levels        2. restores the local TH deficiency in brain.   "
93692|NCT02059733|"     This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients     with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients     with ET, and 10 patients with DT.   "
93636|NCT02060461|"     Laser in situ keratomileusis (LASIK) is a safe and effective method for treating myopia,     hyperopia and astigmatism. It is based on reshaping the cornea to focus the light closer to     the macula. This method includes two steps: a corneal flap creation, which can be performed     by a mechanical microkeratome or a femtosecond laser, and the reshaping of the cornea by     another laser (Excimer laser).      The corneal flap creation is a crucial step. Indeed, creating a flap weakens a large part of     the anterior stroma. The accuracy of the LASIK flap thickness is a key safety consideration     to reduce the likelihood of ectasia following LASIK. Femtosecond laser technology has     significantly improved the results of LASIK flaps, with increased predictability, lesser     induction of optical aberrations, and a better healing profile compared to microkeratome     flaps, with similar visual acuity results.      Femtosecond Laser technology has been extensively investigated for the last ten years for use     in refractive surgery. Actually, four femtosecond laser devices are available to perform     LASIK flaps, each of them having clinical benefits and limitations. A fifth, designed by     WaveLight AG/Alcon Laboratories, Inc. (Erlangen, Germany/Fort Worth, Texas), is approved for     human use by the United States Food and Drug Administration and has been just released in the     US market. Its unique technical aspects, optimized scanning algorithms, and user-friendly     patient interface, have already provided a high reproducibility for cutting three-dimensional     tissues structures in porcine corneas. Furthermore, the device has been shown to minimize     opaque bubble layer (OBL) formation. This condition is very common and responsible for a     delay in the treatment, since it can obstruct the eye tracker.      The objective of this study is to evaluate the visual outcome, accuracy, predictability and     complications of LASIK flap creation using the new Wavelight FS200 Femtosecond laser and     compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The     primary outcome to be evaluated is the flap thickness accuracy.   "
93637|NCT02060448|"     The overall aim of this study is to begin establishing an effective treatment for individuals     who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based     treatments that directly target this problematic behavior. Existing treatments that have     demonstrated initial promise in reducing NSSI consist of many skills embedded in complex     programs; therefore, the skill(s) responsible for improvements in NSSI are not clear.     Procedures that focus on one's emotions, particularly that aim to increase emotional     awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens     emotions), may be critical in effective NSSI treatment. The specific goals of this study are     to investigate the effects of two specific emotion-focused treatment elements on NSSI.     Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual     for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI     disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of     the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al.,     2011) will be adapted and delivered with the aim of reducing participants' non-suicidal     self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute     individual weekly sessions of emotion awareness training or cognitive reappraisal. The study     will use a single-case experimental design, and phase change will be determined based on each     participant's changes in non-suicidal self-injurious thoughts and behaviors.   "
93638|NCT02060435|"     The investigators analyzed clinical outcome in DLBCL patients according to age group to     define the impact of EBV status on the clinical outcome.   "
93639|NCT02060422|"     Psychological problems are prevalent among patients with drug-resistant epilepsy. The     bi-directional interaction between psychological well-being and seizure have been recognized     in recent years. Reduction of psychological stress has the potential to improve seizure     manifestation.      The present study uses an assessor-blinded prospective randomized controlled trial to     evaluate the efficacy of a mindfulness-based psychotherapy and an attentional-placebo social     support on improving psychological well-being, seizure control and cognitive performance     among adult patients with drug-resistant epilepsy.   "
93640|NCT02060409|"     In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate     the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2)     on the outcomes of 1st line decitabine treatment in MDS.   "
93641|NCT02060396|"     This study in healthy volunteers is the first step in developing a collaborative research     program, which seeks to test the hypothesis that chemopreventive effect of acetylsalicylic     acid (ASA) on colon cancer is due predominantly to its antiplatelet effect.      The following features of the clinical evidence are consistent with the platelet-mediated     hypothesis:        1. The apparent saturability of the chemopreventive effect of ASA at low doses given once          daily, found in long-term analyses of cardiovascular and adenoma recurrence randomized          clinical trial, as well as in the vast majority of observational studies performed in          different settings and with different methodology. A remarkably similar saturability of          the cardioprotective effect of low dose ASA given once daily is explained by the          irreversible nature of cyclooxygenase (COX)-1 inactivation in platelets, and limited          capacity of human platelets for de novo protein synthesis.        2. Given the short half-life of ASA in the human circulation (approximately 20 min) and the          capacity of nucleated cells to resynthesize the acetylated COX-isozyme(s), it seems          unlikely that a nucleated target could be suppressed throughout the 24-h dosing          interval.        3. One of the cardiovascular randomized clinical trial (Thrombosis Prevention Trial) in          which the chemopreventive effect of ASA was detected on long-term follow-up, involved          the administration of a controlled-release formulation of ASA (75 mg) with negligible          systemic bioavailability.        4. Enhanced platelet activation and thromboxane (TX)A2 generation in vivo has been          demonstrated in patients with colorectal cancer and in Familial Adenomatous Polyposis          patients.      So, the main objective of this study is to assess the extent of acetylation at serine-529 of     platelet COX-1 after the 1st and 7th dose of low-doseof enteric-coated ASA 100 mg daily.     Changes of this novel biomarker of ASA action will be correlated to other known parameters of     ASA PK and PD: i) Tmax, Cmax and AUC of ASA and salicylate in the peripheral circulation     after oral dosing; ii) time to obtain the maximal antiplatelet effect by ASA and its     persistence throughout the dosing interval as assessed by measuring the inhibition of     platelet COX-1 activity in whole blood ex vivo, the inhibition of platelet aggregation in     whole blood ex vivo and the inhibition of the systemic generation of TXB2.   "
93642|NCT02060383|"     The study aims to demonstrate that pasireotide-induced hyperglycemia can be effectively and     safely managed in majority of patients, including those with diabetes at start of pasireotide     treatment.   "
93646|NCT02060331|"     In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome     nocturia. The International Continence Society (ICS) defines nocturia as having to wake at     night one or more times to void. Though some of this nocturia may be secondary to obstructed     bladder emptying, the investigators hypothesize that in some women compression of the     bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of that     prolapse while the patient lays supine overnight results in nighttime post-obstructive     diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and     nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes     obstruction due to descent of the bladder floor which leads to compression of the bilateral     ureters between the uterus and the borders of the genital opening. No large prospective     studies, however, have evaluated the possible impact of this phenomenon on patients or the     possible post-operative changes following surgical correction of POP.      Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding diaries,     and urine studies, the investigators aim to evaluate the pre-operative and post-operative     voiding habits and urinary parameters of women with severe pelvic organ prolapse and     bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which surgically     obliterates the vaginal lumen to treat severe POP in properly counseled patients with >90%     satisfaction rates. Other treatments offered to women, such as the laparoscopic or open     sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension, also     offer high rates of success. The investigators aim to determine whether surgical correction     of severe pelvic organ prolapse, to be defined as either with colpocleisis, laparoscopic or     open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension,     results in improvement and/or resolution of nocturia and post-obstructive diuresis.   "
93647|NCT02060318|"     Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17     cells and other immune cell types) or biomarkers can be used to predict the response or lack     of response to treatment with Infliximab. If so, characteristics of the immune cells may also     unveil the mechanisms behind lack of response to Infliximab.      Design: a prospective, observational study with three arms. In the treatment group, 35     patients with Crohn's disease about to start Infliximab-treatment are recruited. They have     blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks     of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated     once. All treatment and follow-up are according to national guidelines, and data from this     study is not used by the clinicians.      Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is     investigated using flow cytometry. From plasma and serum samples, various proteins     (biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor     alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical     history) are extracted from various registries.   "
93648|NCT02060305|"     Primary Objective The efficacy of intra-articular bevacizumab injection for secondary     prevention of recurrent hemarthroses for hemophilia patients who has had target joints with     chronic synovitis. The safety profiles of intra-articular bevacizumab injection for     hemophilia patients.      Study Population Adult hemophilia patients who have had one or more target joints with     chronic synovitis and recurrent hemarthroses.      Investigational therapy: Intra-articular injection of Bevacizumab (20 or 40 mg/ 0.8 or 1.6     ml/ dose) every month (28 days) for up to 4 months, depending on the improvement of target     joint bleeding.      Study Design The estimated study period is between Jan 2014 and Dec 2015. Totally 10 joints     will be enrolled for this pilot study. Before enrollment, the joint(s) will be evaluated for     their severity both clinically (by 10-point Pain Score, range of motion for the target joint,     and World Federation of Hemophilia Score) and by MRI (using the compatible MRI scales     developed by International Prophylaxis Study Group [IPSG]). Intra-articular injection of     bevacizumab will be administered, after prophylactic factor supplementation, every month for     up to four injections. In the first four patients, 20mg of bevacizumab will be administered.     If there are no Gr 3 or Gr4 dose-limiting toxicities, bevacizumab dose will be escalated to     40mg in the other 6 patients. Before every procedure, the plasma and the synovial fluid     samples will be collected for VEGF quantification for the correlative biomarker study. After     completing the protocol treatment, the efficacy parameters as well as the safety profiles     will be evaluated.   "
93649|NCT02060292|"     Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to     severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and     is likely to profoundly influence an individual's ability to manage their disease.      In addition to cerebral small vessel damage and cognitive dysfunction, other organs such as     the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD.     Several large population studies have shown that COPD is a significant independent risk     factor for myocardial infarction, with the effect most marked in early, mild disease.      We propose to compare non-invasive MR brain imaging of white matter microstructure (diffusion     tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel     disease (cerebral microbleeds), in COPD patients to smokers without COPD. In addition we plan     to explore mechanisms of cerebral small vessel disease in COPD by looking for associations     between arterial stiffness, end organ vascular damage and cognitive function.   "
93650|NCT02060279|"     This is a pilot study of children between the ages of 8 to 11 years of age who are obese and     participating in an intense family based intervention with a family-focused multi-component     lifestyle intervention. In addition, a beta-carotene supplement will be administered to     randomized participants.   "
93651|NCT02060266|"     This trial is conducted in Europe. The aim of the trial is to investigate the absorption,     metabolism and excretion after a single subcutaneous dose of [3H]-semaglutide in healthy male     subjects.   "
93652|NCT02060253|"     This phase I trial studies the side effects and best dose of ganetespib when given with     paclitaxel, trastuzumab and pertuzumab in treating patients with human epidermal growth     factor receptor 2 positive (HER2+) metastatic breast cancer (MBC).   "
93653|NCT02060240|"     The purpose of the study is to see if a twelve-week exercise intervention in overweight or     obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved     skeletal muscle capillary blood flow by improving substances that dilate blood vessels and     result in improved insulin sensitivity.   "
93654|NCT02060227|"     The primary research question is to determine whether patients who undergo a stabilization of     the shoulder using a novel decision-making algorithm (ISIS Score) have improved     disease-specific quality of life at 1 year post-operatively, as measured by the Western     Ontario Instability Index (WOSI) compared with patients who undergo stabilization using a     conventional decision-making algorithm. Secondary outcomes include the American Shoulder and     Elbow Surgeon's (ASES) score, and difference in recurrence rates of dislocation between the     two decision-making algorithms.   "
94258|NCT02052323|"     The purposes of this study is to determine parasitological clearance rates by microscopy for     the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum     malaria.   "
93655|NCT02060214|"     Urinary urgency is the key symptom of overactive bladder (OAB). A critical barrier in     understanding OAB is the lack of a method to separate urgency that derives directly from     bladder filling or what we term tension sensor output and urgency that derives from     abnormal brain interpretation. The central hypothesis is that measureable biomechanical     parameters can directly affect the output (urgency) of the detrusor tension sensor.      The development of novel cystometric tests for the improved diagnosis and treatment of OAB     and for the potential identification of novel mechanistic targets in the pathophysiology of     OAB.   "
93693|NCT02059720|"     A multicentre, prospective, open-label clinical study, including a randomized controlled     study in low or intermediate-risk group patients, and a cohort study of maintenance treatment     with decitabine after ASCT.   "
93694|NCT02059707|"     The objective is to assess the effectiveness of permanent exclusion of the LAA with the     LARIAT RS Suture Delivery Device and accessories in AF patients.   "
93695|NCT02059694|"     To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local     anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.   "
93656|NCT02060201|"     The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and     Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral     administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered     orally together in the fasted state and to demonstrate the BE of Saxagliptin and     Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral     administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered     orally together in the fasted state. Demonstrating bioequivalence refers to showing that the     FDC tablet and co-administration of the individual components yield similar blood     levels/concentrations of the drug and are handled by the body similarly.   "
93657|NCT02060188|"     The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination     with other anti-cancer drugs, will result in meaningful tumor size reduction, in patients     with colon cancer that has come back or has spread, and who have a specific biomarker in     their tumors.   "
93658|NCT02060175|"     We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between     the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not     been evaluated yet for both the Cilotax and DESyne and we first sought to decide the     reference intervals using 40 samples (total 44 patients for each group considering 10%     drop-out rate) as the pilot study.   "
93659|NCT02060162|"     This is a prospective HIV cohort that aims to establish causes of liver disease among     HIV-infected individuals in Zambia, including viral hepatitis and alcohol.   "
93660|NCT02060149|"     The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB) is     still high, even if these patients received certain strong anti-infection treatment such us     the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining fluid     is mildly alkaline but airway acidification usually appears for the infection of XDRAB. The     hypothesis is offered that the biologic activity of XDRAB might be inhibited if the     circumstance including pH is changed. In the vitro study we observed that the inhibit effect     of antibiotics on XDRAB growth was improved significantly by alkaline solution within the     scope of physiology. So the aim of this clinical study is to explore the effects of     nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.   "
93661|NCT02060136|"     Urinary diaries have proven to be beneficial in assessing lower urinary tract symptoms     (LUTS), however they have not achieved widespread acceptance. The likely reason is the fact     that the pen and paper diaries are labor intensive for both patient (need to carry a pen and     paper and record each event) and doctor (need to transfer, summarize and analyze the data).      Hypothesis: Electronic voiding diary, would automate the recording and analysis of data,     expedite the process, improve its accuracy and cost effectiveness.      Electronic recording of lower urinary tract symptoms (SUF) uses wireless phone and web based     technologies to record LUTS remotely and store the data on a secure website which can be     accessed by the doctor or patient whenever needed. The goal of this study was to compare its     validity and reliability to the traditional micturition chart (MC) recording method - the     current gold standard where the patient records the time of micturition and degree of urgency     using a pen and paper.   "
93662|NCT02060123|"     The purpose of this study is to evaluate the effect of a qigong intervention program on     telomerase activity in Chinese women with a history of intimate partner violence.   "
93663|NCT02060110|"     The registry is designed to determine the long-term mortality and morbidity benefit as a     result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable     Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The     registry will collect data on patients that previously participated at MADIT-CRT sites within     Europe through five years of participation from their orginal enrollment in the MADIT-CRT IDE     study.   "
93664|NCT02060097|"     Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the     intrinsic aging process, and accounts for the majority of age-associated changes in skin     appearance. Reactive oxygen species (ROS) likely contribute to this process. Strategies     utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have     been examined.      Cocoa beans fresh from the tree are exceptionally rich in polyphenols, such as flavanol, and     have a higher antioxidant capacity. The present study is designed to investigate the effects     of long-term intake of a product rich in cocoa flavanols on facial wrinkles, hydration,     elasticity and photosensitivity.   "
93665|NCT02060084|"     Gut of newborn preterm is sterile, immediately by the mother and the surrounding environment     from microbial colonization. As the effects of diet, intestinal flora is rapidly changed.     Preterm children significantly delay in the establishment of normal flora,during     hospitalization because of no breastfeeding, use of antibiotics, enteral feeding delay,     combat disease and other factors. In this study, hospitalized preterm children for the study,     the prospective randomized double-blind controlled study, to find oral intestinal     bifidobacteria and lactobacilli and bifidobacteria subspecies composition and distribution,     and further show intestinal bacteria in premature children case group.   "
93666|NCT02060071|"     There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the     aortic valve.   "
93667|NCT02060058|"     The aim of this study is to explore the efficacy and safety of boceprevir -based triple     therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to     previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.   "
93668|NCT02060045|"     The objective of the investigators work was to evaluate the impact of 4 sequentially     implemented measures for preventing VAP in a major heart surgery ICU. The measures were a     specific training program, aspiration of subglottic secretions (ASS), introduction of an     inclinometer to improve the semirecumbent position, and reinforcement of oral care with     chlorhexidine.   "
93696|NCT02059681|"     The purpose of this study is to evaluate whether endocavitary intramyocardial injection of     autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events,     with follow-up assessments extending up to 1 year after enrolment.   "
93697|NCT02059668|"     The aim of this clinical research project is to validate the prognostic impact of potential     biomarkers on loco-regional control of locally advanced head and neck cancer after definitive     or adjuvant radiochemotherapy. The treatment is equal to the standard of care.      Potential biomarkers from a previous retrospective study will be validated in this     prospective study.   "
93669|NCT02060032|"     Background: Statins are the recently evolved agents that aid in periodontal regeneration and     ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are     specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The     present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2%     SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic     periodontitis.      Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV,     SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI),     modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level     (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic     defect depth reduction was evaluated using computer-aided software at baseline, 6 months and     9 months.   "
93670|NCT02060019|"     This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate,     valsartan and rosuvastatin in healthy male volunteers.   "
93671|NCT02060006|"     Background: Non-Steroid Anti-Inflammatory Drugs (NSAIDs) reduce pain and inflammation by     inhibiting cyclooxygenase, an enzyme in the pathway for formation of prostaglandins and     thromboxane. Prior studies have proven the role of ibuprofen (an NSAID) in modulating lung     injury and decreasing pulmonary damage in cystic fibrosis. While there has been an intense     effort by the scientific community to define the best treatment strategies for tuberculosis     immune reconstitution inflammatory syndrome (TB-IRIS), to our knowledge there is no available     study evaluating preventive strategies using anti-inflammatory agents for TB-IRIS, a highly     morbid complication in HIV-infected TB patients initiating antiretroviral therapy (ART).      Design and Methods: We propose to conduct a single center double-blind placebo-controlled     randomized trial to investigate the efficacy of daily self-administered Meloxicam (a NSAID)     versus placebo for prevention of Tuberculosis associated Immune Reconstitution Inflammatory     Syndrome (TB-IRIS). A total of 150 HIV-infected adults who are treated for Tuberculosis for     at least 2 weeks and about to initiate HIV treatment at Brewelskloof Hospital, Worcester, and     Tygerberg Teaching Hospital, Cape Town, will be randomized to one of the following     treatments: Meloxicam 7.5 mg tablet once-a-day, the experimental arm, versus Placebo tablet     once-a-day, the control arm, for 8 weeks. All patients will be followed up for 12 months.     Primary efficacy outcome: The decrease of the incidence of paradoxical TB IRIS by at least     20%; Primary safety outcome: The proportion of patients who temporarily or permanently     discontinue Meloxicam due to any adverse event (e.g. dyspepsia or gastro-intestinal upset).     Secondary outcomes are: 1) the proportion of patients in each arm with the following     indicators of TB-IRIS severity/quality of life (QOL) (degree of pain or discomfort >III,     presence of local or disseminated suppuration/abscess of any site, unscheduled clinic visits,     hospitalizations, missed more than a day at work, etc; 2) The incidence of other types of     IRIS (e.g. Kaposi Sarcoma or cryptococcal meningitis).      This study will provide important and novel data on the feasibility and efficacy of using a     cheap, widely available NSAID used in both developed and developing countries, as a     preventive intervention for TB-IRIS that could be quickly put into practice if proven to be     effective   "
93672|NCT02059993|"     Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous     study has suggested that OSA significantly increases cardiovascular morbidity and mortality,     especially in patients with pre-existing cardiovascular disease.The standardized treatment of     moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term trials     indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies have a     relative short duration with only but few more than one year. In our opinion, they are not     sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact of OSA     on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could     reduce blood pressure and improve metabolic disorder in patients with coronary heart disease     (CHD)and OSA.   "
93673|NCT02059980|"     Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are     characterized by the marked difficulty in inhibiting unwanted or inappropriate responses.     There is compelling evidence that poor response inhibition is a core cognitive feature of OCD     and its related disorders, but no effective intervention exists that directly attempts to     address this problematic cognitive deficiency. This study will examine the feasibility and     clinical utility of a computerized cognitive training program designed to improve response     inhibition among individuals diagnosed with OCD or trichotillomania.This training program     offers systematic practice of response inhibition in the form of a 40-level computer game.     Individuals with these conditions will be randomized to either 8 sessions of (a) computerized     response inhibition training (RIT) or (b) placebo computer training (PLT). We hypothesize     that RIT will outperform PLT in improving response inhibition capabilities and reducing     relevant clinical symptoms. In sum, this project is expected to generate important knowledge     to guide the development of effective computer-based treatment approaches that may help     reduce critical problems of existing treatments such as suboptimal patient retention and     treatment under-utilization, thereby improving overall treatment response rates among     individuals suffering from OCD and related conditions.   "
93674|NCT02059967|"     This phase I trial studies the side effects and best dose of image-guided adaptive radiation     therapy using active breathing control when given together with chemotherapy and simultaneous     integrated boost in treating patients with stage IIA-IIIB non-small cell lung cancer that     cannot be removed by surgery. Image-guided adaptive radiation therapy aims radiation therapy     right at the tumor so that higher radiation doses can be given without causing bad side     effects. Giving these higher doses may help control the tumor better. Breathing causes organs     and tissues, including the tumor, to move within the chest. Active breathing control may     reduce the volume that needs to be treated. Drugs used in chemotherapy, such as paclitaxel     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving image-guided adaptive radiation therapy     using active breathing control with chemotherapy and simultaneous integrated boost may be an     effective treatment for non-small cell lung cancer.   "
93675|NCT02059954|"     Hysterectomy for benign indication is one of the most common surgical procedures in women.     Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but     the proportion of laparoscopic (and robotic) hysterectomies is increasing.      This study will compare a range of clinical and subjective outcomes of vaginal vs. total     laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to     work as well as cosmesis, quality of life and sexual health.   "
93676|NCT02059941|"     Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury     (sTBI) is crucial to their survival and optimal recovery. The evidence-based Guidelines for     the Management of Severe Traumatic Brain Injury, 3rd Edition recommends use of intracranial     pressure (ICP) monitors to assess ICH and guide intervention. Unfortunately, only a small     percentage of the world has the resources and capability to routinely monitor ICP.      The objective of this proposal is to create and test guidelines for the treatment of severe     TBI in the absence of ICP monitoring.   "
93677|NCT02059928|"     In emergency situations, access to the venous system is essential in order to administer     fluids and medication and to monitor patients. When peripheral veins are difficult to access     or the patient's condition requires certain medications, or monitoring, central venous     catheters (CVC) are inserted. CVC placement introduces a much higher level of risk compared     to peripheral catheters. The technique of intraosseous (IO) infusion has been used by     healthcare professionals for several decades, but recently has gained wide popularity in the     emergency care settings. This technique allows providers to secure a needle in the bony     matrix at the ends of long bones (tibia and humerus) and infuse fluids and medications into     the intramedullary space. The ability to monitor a patient's blood pressure through an     intraosseous needle is unknown. The primary objective of this study is to describe the     relationship (ratio) of intraosseous pressure (IOP) values to standard pressure values,     including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial     pressure (MAP), and central venous pressure (CVP).   "
93678|NCT02059915|"     To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs.     Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers   "
93679|NCT02059902|"     Thermal injury results in one of the most intense and prolonged forms of pain the body can     experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and     their use in the perioperative period has been the mainstay of treatment; although medication     requirements in burn patients are often underestimated. More medication may not be the     answer, as relatively large doses of short acting opioids in the operative theater are     associated with greater postoperative opioid consumption and higher pain scores. Furthermore,     extensive use of opioids has resulted in the development of by hyperalgesia and allodynia.     Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic,     and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used     for perioperative pain management in a variety of surgical procedures. The design of this     study will examine if lidocaine will reduce the pain scores and narcotic utilization in     patients undergoing surgical procedures for burn injuries. The intervention group will     receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The     control group will get an equal volume of saline. The investigators will compare pain scores,     opioid use, and narcotic equivalents based on body weight and burn surface area (BSA)     grafted.   "
93680|NCT02059889|"     This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in     identifying and localizing tumors in patients with non-small cell lung cancer undergoing     radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify     where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results     of diagnostic procedures done before, during, and after radiation therapy may help determine     how the location and volume of tumors changes over time and predict how the tumor will     respond to therapy.   "
93681|NCT02059876|"     The purpose of this study is to determine the efficacy and safety of dose-dense(biweekly)     carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer.   "
93682|NCT02059863|"     A large number of children in developing countries lack access to known effective     interventions. Almost 9 million die each year before reaching their fifth birthday, and over     200 million children who survive fail to achieve their full growth or developmental     potential, trapping them in a cycle of continuing disadvantage. The goal of SPRING,     Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative approach     to close this access gap, in two of the worst affected countries India and Pakistan, using     community based agents. Extensive formative research will be carried out to help ensure that     the content and approach of the SPRING intervention is feasible, acceptable and     appropriately targeted. Findings will be reviewed at an intervention development workshop     with local and international stakeholders and experts, and the agreed intervention piloted     with a few community based agents and their supervisors. Cluster randomised controlled trials     will be carried out in each setting to evaluate the impact of SPRING on child growth,     development and survival. The programme will include process and economic evaluations to     provide information on the total cost of the intervention and its cost effectiveness, as well     as development of a framework with lessons learned for implementing SPRING in other     settings.   "
93683|NCT02059850|"     This phase I trial studies the side effects and best way to give NY-ESO-1 specific T cells     after cyclophosphamide in treating patients with advanced synovial sarcoma or myxoid/round     cell liposarcoma. Placing a gene that has been created in the laboratory into white blood     cells may make the body build an immune response to kill tumor cells. Drugs used in     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving NY-ESO-1     specific T cells with cyclophosphamide may kill more tumor cells.   "
93684|NCT02059837|"     This study is conducted to evaluate its morphologic reproliferating patterns in patients with     pterygium treated with the excision and conjunctival autograft.   "
93685|NCT02059824|"     The purpose of this study is to determine normal eyelid sensation distribution using a     Cochet-Bonett Aesthesiometer.   "
93686|NCT02059811|"     More than two-thirds of US adults with chronic kidney disease (CKD) have uncontrolled     hypertension. Both hypertension and CKD are major independent risk factors for cardiovascular     disease, which is the leading cause of death in the US. Fortunately, lowering blood pressure     to recommended treatment targets not only slows the progression of CKD, but also improves     cardiovascular outcomes. Controlling hypertension in this patient population, however, can be     quite challenging. A lifestyle modification that effectively reduces blood pressure in both     pre-hypertensive and hypertensive adults is the Dietary Approaches to Stop Hypertension     (DASH) diet.      The purpose of this pilot study is to (1) determine the extent to which the DASH diet lowers     blood pressure in hypertensive adults with moderate chronic kidney disease (CKD) (estimated     glomerular filtration rate [eGFR] 30-59 ml/min/1.73m2) and (2) establish that the DASH diet     can be safely consumed by this patient population.   "
93687|NCT02059798|"     Hypotheses:      Decompressive surgery of cervical myelopathy will improve bladder function.      Decompressive surgery of cervical myelopathy will improve sexual function.   "
93688|NCT02059785|"     This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study.     Chinese subjects with Ischemic Stroke.   "
93698|NCT02059655|"     The purpose of the study is to establish whether Bimatoprost eye drops are effective in     reducing proptosis in inactive thyroid eye disease (TED) patients and improving quality of     life in patients with TED. Current standard NHS treatment/care for inactive TED is artificial     tears (used as the placebo in this study) or surgery if appropriate.      The IMP is Bimatoprost eye drops PGF2α (0.03%). This is already licensed eye drops usually     used for glaucoma. Therefore the current trial's indication is outside its licenced     indication. The Investigational Medicinal Product (IMP) will be used according to its     licenced dosage and form. This is the first time that Bimatoprost will be used in the     treatment of TED   "
93699|NCT02059642|"     This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of     MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with     ADHD.   "
93700|NCT02059629|"     The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna     pacemaker family and the Sentus BP (bipolar) left ventricular lead.      Furthermore the new wandless RF telemetry function SafeSync and the handling of the Sentus     lead during implantation will be assessed.   "
93701|NCT02059616|"     The purpose of this study is to explore the optimal dose of fixed-dose combination of     candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the     combination therapy compared to each of the monotherapy in patients with essential     hypertension.   "
93702|NCT02059603|"     Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao,     Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after     laparoscopic colorectal surgery within a traditional perioperative care setting. Recent     evidence also suggested that a 'fast-track' perioperative program may help accelerate     recovery after colorectal surgery. As electroacupuncture is simpler to implement and less     labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to     fast-track program in reducing the duration of postoperative ileus and hospital stay after     laparoscopic colorectal surgery.      Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing     the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.      Design: Prospective, randomized, noninferiority trial.      Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic     resection of colonic and upper rectal cancer will be recruited.      Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture     with traditional perioperative care; or (B) fast-track program without acupuncture.      Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of     hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic     requirement, morbidity, and medical costs.      Conclusions: This study will determine if electroacupuncture is noninferior to fast-track     program in reducing the duration of postoperative ileus and hospital stay after laparoscopic     colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to     laparoscopic colorectal surgery because it is simpler to implement and less labor intensive     than fast-track program.   "
93703|NCT02059590|"     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product     (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage     product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled     prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of     BAL8728 in human plasma, urine and/or feces after a single intravenous dose of     pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815.     Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled     isavuconazonium sulfate will also be evaluated.   "
93704|NCT02059577|"     70 children and adults with autism spectrum disorders will be enrolled in a 1-year,     single-blind treatment study. Assessments will be conducted at the beginning and end of the     study, including measurements of nutritional, metabolic, and digestive status and assessments     of autism severity and overall functioning. Half of the participants will be randomized into     a treatment study, and half will be randomized to no changes in their current treatments.     Treatments will be added in a sequential manner over 12 months, including vitamin/minerals,     essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free     diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the     participants throughout the study.      A group of 50 neurotypical children and adults, of similar age and gender, will be included     for comparison.   "
93705|NCT02059564|"     A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label     Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator     on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus   "
93706|NCT02059551|"     Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an     alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE)     due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study     is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the     legs in patients with suspicion of PE.   "
94259|NCT02052310|"     The purpose of this study is to determine whether FG-4592 (roxadustat) is safe and effective     in the treatment of anemia in patients who have just begun dialysis treatment for end stage     renal disease.   "
93707|NCT02059538|"     Supported by state-of-the-art systems medicine competences including integrative     computational and functional genomics, the overarching goal of the trial is to investigate     the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis     of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective     will be to translate the clinical and fundamental based discoveries into new diagnosis and     preventive actions paving the way to novel modes of treatment in the successive stages of CMD     progression.   "
93708|NCT02059525|"     This study is part of the Search for a Treponema pallidum Antigen Test (SeTPAT) project to     study the proteomic, immunological, serological and clinical changes associated with pre- and     post-treatment syphilis infection in a way that could ultimately lead to the development of a     new ELISA and rapid diagnostic test of T. pallidum antigenaemia.      The general aim of this prospecive observational cohort study is thus to quantify a set of     target proteins with the highest diagnostic potential for the diagnosis of initial T.     pallidum infection and T. pallidum persistence. A test which could directly detect the     presence of T. pallidum antigens could represent a considerable advance over currently used     tests in the diagnosis of initial syphilis infection, its response to therapy and in the     diagnosis of syphilis reinfections. This prospective observational cohort study of     HIV-positive patients with a new diagnosis of syphilis infection will be conducted at the     HIV/Sexually Transmitted Infections (STI) Clinic at the Institute of Tropical Medicine,     Antwerp.   "
93709|NCT02059512|"     The purpose of this study evaluate the effect of the method of administration of autologous     bone marrow mononuclear cells for the duration of of functioning aorto-coronary bypass grafts     in the surgical treatment of coronary heart disease, to assess the degree of effectiveness     depending on the method of transplantation (intramyocardial, intracoronary).   "
93710|NCT02059499|"     This randomized phase III trial studies imiquimod or fluorouracil to see how well they work     compared to observation in treating patients with high-grade anal squamous skin lesions who     are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may     stimulate the immune system in different ways and stop tumor cells from growing. Drugs used     in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. It is not yet known     whether imiquimod or fluorouracil is more effective than observation in treating high-grade     anal squamous skin lesions.   "
93711|NCT02059486|"     The purpose of this study is to evaluate the impact of the Teen Choice program on reducing     the rates of unprotected sex of high risk youth in New York.   "
93712|NCT02059473|"     The purpose of this project is to compare operative repair of traumatically torn rotator cuff     tendon with physiotherapy in a randomized prospective study.   "
93713|NCT02059460|"     To study the impact of intra and post-operative Terlipressin infusion on the occurrence of     acute kidney injury after LDLT To investigate perioperative Neutrophil Gelatinase Associated     Lipocalin (NGAL) changes and study the effect of Terlipressin on NGAL blood levels   "
93714|NCT02059447|"     The principal hypotheses to be tested is that Mindfulness Based Cognitive Therapy (MBCT)     reduces the distressing impact of tinnitus to a significantly greater extent than a waiting     list control or relaxation therapy.      This study is a mixed design, with two groups assessed at a number of time points. The     primary outcome measure will be that of tinnitus distress, and secondary outcomes will be     taken of psychological distress and tinnitus loudness.      The outcome measures will be measured first at 8 weeks pre-treatment. All subjects then wait     for 8 weeks before being randomly allocated to either an 8 week course of Mindfulness-Based     Cognitive Therapy (MBCT) (Group 1) or an 8 week course of Relaxation Therapy (RT) (Group 2).     All participants will be assessed at two main time-points (pre and post-treatment). The     outcome measures will be repeated at 1 and 6 month follow-up points.   "
93715|NCT02059434|"     The purpose of this study is to assess the safety and tolerability of single doses of     LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to     severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of     LAS190792 to produce bronchodilation (opening of the airways).   "
93716|NCT02059421|"     The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and     Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in     survivors of critical illness. Subjects will be recruited following discharge from the     Intensive Care Unit (ICU) and followed for 6 weeks. All subjects will undergo objective     measurements of sleep quality and duration at baseline and at 6 weeks. Objective measurements     will be made by portable (home-based) sleep studies and will wear a watch that measures     sleep. Subjective measurements will be performed by sleep questionnaires: PSQI, Epworth     sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed at     baseline, 2 and 6 weeks. A blood draw and urine collection will be done at both baseline and     6 weeks.      The central purpose of this proposal is to perform a comparative-effectiveness study of a     complementary and alternative approach (Johrei therapy) and CBT-I in the treatment of sleep     disturbances in survivors of critical illness. The investigators hypothesize that, in     survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in improving     sleep quality (Pittsburgh Sleep Quality Index [PSQI] and sleep efficiency [measured by     polysomnography]).      A secondary objective is to compare the effect of Johrei therapy and CBT-I on systemic     markers of inflammation and urinary biomarkers of sleep and stress. The investigators     hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable     to CBT-I in reducing systemic markers of inflammation and urinary biomarkers of sleep and     stress.      A tertiary objective is to determine whether the presence of insomnia or other sleep     characteristics is associated with hospital readmissions within 30-days.   "
93717|NCT02059408|"     The overall hypothesis of this trial is that screening for chronic kidney disease, followed     by education or treatment program will improve blood pressure control among hypertensive     non-diabetic persons.   "
93735|NCT02059174|"     The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of     MK-1293 compared with a basal insulin (EU-Lantus™) in participants with Type 1 Diabetes. The     primary hypotheses are that the duration of action, pharmacodynamic profile, and     pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.   "
93718|NCT02059395|"     Background:      In cardiac arrest survival rates dramatically increase when bystanders are present and     initiate Basic Life Support (BLS). However, even though serious efforts have been made, skill     retention after a traditional time-based BLS course for laypeople remains suboptimal. In     contrast, a mastery learning-based educational approach was shown to be efficacious and might     be promising even for laypersons. Therefore the investigators aim to evaluate the impact of a     mastery learning-based BLS course on skills retention of BLS in laypeople.      Methods:      Forty laypeople without previous BLS experiences will be randomized into the traditional     time-based BLS course group (Control - TB group) or mastery learning-based group     (Intervention - ML group).      Both groups will receive BLS training consisting of 6 successive stations including diagnosis     of cardiac arrest, chest compression, ventilation, one-rescuer BLS, two-rescuer BLS and AED     use. In the ML group, subjects will deliberately practice and receive feedback at each     station until a pre-set target level is reached. Subjects will be allowed to proceed to the     next station only when they achieve the required target level of performance. In contrast,     participants of the TB group will be taught the same 6 stations in two hours, according to     standard American Heart Association BLS criteria. All subjects will have an assessment of     knowledge and skills immediately after teaching (immediate post-test) and at four months     (retention post-test).      Implications:      Previous research has shown that mastery learning-based education improves learners'     procedural skill performance. The investigators study will determine the impact of a mastery     learning-based BLS course on skill retention in laypeople.   "
93726|NCT02059291|"     ThIS study is to determine whether canakinumab is able to induce and maintain a clinically     meaningful reduction of disease activity in participants with Hereditary Periodic Fevers     (HPF) compared to placebo.   "
93719|NCT02059382|"     The purpose of this study is to inform the integration of mobile and social media components     into larger interventions aimed at increasing adherence and maintenance of physical activity.     Nearly half of the US population do not meet physical activity recommendations of ≥150     minutes of moderate activity per week. The use of smartphones to self track data and upload     that data to an online social network is becoming increasingly common and may be an effective     way to motivate physical activity adherence and maintenance. We are proposing a two phase     study to develop and evaluate a mobile health (mHealth) intervention that includes the use     of two existing technologies: 1) the RunKeeper mobile app to collect and upload exercise data     (distance, pace, time), and 2) the RunKeeper.com online social network as a place to analyze     uploaded data and engage with a coach and online community. Phase 1 (n=10) will iteratively     develop the mHealth intervention and phase 2 (n=30) will pilot the mHealth intervention     (participants will be randomized to either mHealth intervention (n=20) or control (n=10)) to     collect feasibility, acceptability and preliminary efficacy data. All participants will     attend a day-long ChiWalk/Run training to help them avoid potential injuries and meet their     coach and community in-person. All participants will also be asked to wear a FitBit     accelerometer from one week before the beginning of the intervention through one week after     the end of the intervention to collect total physical activity data. This data will be     uploaded automatically to the study data base. Primary outcomes will be total physical     activity as collected by the FitBit accelerometer (and the RunKeeper mobile app for the     intervention group) and secondary outcomes will be changes in psychological factors that may     mediate adherence to physical activity.   "
93720|NCT02059369|"     While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for     paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches     are used for substrate modification: linear lesions, ablation of complex fractionated atrial     electrograms (CFAE) or a combination of both. The aim of this study is to determine whether     there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE     ablation in combination or not with linear lesions in patients with persistent AF.   "
93721|NCT02059356|"     The purpose and objective of this study is to determine the prevalence of elevated ammonia     levels in subjects with cognitive impairment, and to observe if treating the cause of the     elevated ammonia level improves mental status. This study does not include any imaging,     treatment,or interventions, other than the blood draws. The blood draws will be taken to     assess blood ammonia level and liver function. If the the ammonia level is not elevated, no     further lab draws will occur. If the ammonia level is elevated, liver function is normal, and     a cause for the high ammonia level is revealed with a plan for clinical treatment by the     subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3     months after treatment. The main risk to subjects is related to the blood draw (i.e.     momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a     potential loss of confidentiality. A paired student t test will be done with the two later     blood to compare objective data.   "
93722|NCT02059343|"     Dexmedetomidine is increasingly used for sedation in children placed on cardiopulmonary     bypass for heart surgery. It is also often used after surgery and may be particularly helpful     for children with heart disease. In order for this medication to be helpful and to minimize     risks associated with taking the medication, it is important to provide correct dosing for     this medication. Based on evidence from studies of other medications used during heart     surgery, it is likely that dosing of dexmedetomidine while on cardiopulmonary bypass is     different from dosing in other settings. The purpose of this study is to evaluate how the     heart-lung bypass machine affects dexmedetomidine levels in the body.   "
93723|NCT02059330|"     This study will investigate the dose-proportionality of palbociclib pharmacokinetics in     healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will     receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days     between doses. Additionally, this study will investigate the effect of Japanese ethnicity of     palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level     between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian     subjects.   "
93724|NCT02059317|"     The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax,     an indicator of local dynamic stability) of chronic low back pain patients versus that of     healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low     back pain patients).   "
93736|NCT02059161|"     The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in     participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in     hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293     compared with participants treated with Lantus™.   "
93737|NCT02059148|"     Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days     apart. One dose will be given with a standard meal, one dose with a high-fat meal and one     dose without food. The study will evaluate the effects of the standard and high-fat meals on     how much drug gets into the bloodstream. Side effects will be documented. This study is     approximately 43 days, not including screening. Screening is required within 28 days prior to     the start of the study.   "
94301|NCT02051764|"     This study will evaluate the imaging characteristics of 18F-AV-1451 in subjects with a     previous 18F-AV-1451 scan in order to assess the rate of change of tau deposition over time.   "
93725|NCT02059304|"     The aim of this study is to examine the potential value of cervical length (CL) measurement     with embryo transfer catheter in the prediction of spontaneous preterm deliveries in     intracytoplasmic sperm injection (ICSI) cycles.      Preterm birth is the leading cause of perinatal death and handicap in children. It is clear     that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there     is an estimated two-fold increased risk following ICSI.      CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the     prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that     at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been     shown that the measurement of CL on pregnancy is an effective method for identification of     the group at high risk for PTD.      In embryo transfer, catheter is placed the through cervical canal. The method we will use in     this study, CL measurement with transfer catheter, will give more precise results than     measurement with ultrasound.      No study has been performed to evaluate the prediction of PTD by analyzing measurements of     CL, preconceptionally. Our study will be the first in this topic.      There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of     prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related     to the gestation at which treatment is initiated. If we know the risk of PTD before     gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that     also increase the relative risk of PTD, in ICSI pregnancies.   "
93729|NCT02059252|"     SmartMatrix™ is a single layer dermal replacement scaffold for full thickness skin     replacement. The scaffold consists of a porous matrix of cross-linked human fibrin plus     alginate that has been designed and optimised to facilitate wound closure and healing through     cellular ingress and rapid growth of new blood vessels.      This proof of concept study will involve patients with surgical wounds resulting from the     excision of basal cell carcinoma (BCC) and squamous cell carcinoma SCC).   "
93730|NCT02059239|"     This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not     respond to treatment or has returned after responding to previous therapy, and who are in     need of a stem cell transplant.      The purpose of this study is to test the safety and effectiveness of giving the drug     Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell     transplant for lymphoma that has not achieved a complete response to salvage (treatment used     for relapsed disease) chemotherapy.   "
93731|NCT02059226|"     Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a     disorder and serious enough to require treatment affects up to 10% of all youth by the age of     16. Anxiety disorders can have serious negative effects on a young person's personal     relationships, school performance, and family life. These disorders may not be discovered by     youth, parents and health care providers. Even if anxiety disorders are discovered, youth may     not get the right therapy. Anxious youth can become sick if their anxiety is not treated     properly.      The investigative team will carry out research to test Breathe, their new Internet-based     treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe     includes information materials and personalized homework assignments to help anxious youth     learn ways to manage anxiety.      This study is a pilot randomized controlled trial (RCT) with two groups, an     Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a     resource webpage (control group; considered treatment as usual for youth waiting for     services). The investigators will evaluate several methodological processes and outcomes     through the following objectives:        1. To evaluate the change in youths' anxiety (primary outcome) from pre- to post-          intervention.        2. To estimate recruitment and retention rates for a full-scale RCT.        3. To estimate a sample size for a full-scale RCT.        4. To define the minimal clinically important difference (MCID) for the primary outcome          measure.        5. To measure intervention acceptability.        6. To determine the use of co-interventions during the trial.        7. To conduct a preliminary economic analysis.   "
93732|NCT02059213|"     This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen     Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive     prostate cancer.      The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen     Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may     significantly increase the efficacy of ADT.   "
93733|NCT02059200|"     Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for     patients suffering from recurrent depression. Though a number of studies show that MBCT is     effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent     depressive patients, the chance of a new depression developing after end of treatment is     still considerable. Ergo, there is room for improvement.      Especially the development of a non-judging or compassionate attitude towards all experience     seems to mediate the treatment effect. It is therefore our expectation that a follow-up     intervention that focuses specifically on self-compassion could prove very useful in     elaborating on the effects of MBCT.      The research question of this research is therefore: what is the effect of compassion     training in people suffering from recurrent depression who have already received MBCT     training?   "
93734|NCT02059187|"     This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants     with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean     change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in     participants treated with MK-1293 compared with that in participants treated with Lantus™.   "
93738|NCT02059135|"     The purpose of the study is to assess the efficacy, safety and pharmacokinetics (PK) of     recombinant human antithrombin (ATryn) in addition to expectant management for the treatment     of preterm preeclampsia (PPE). Efficacy will be assessed by comparing the difference in     extension of gestational age from the time of randomization into the study until delivery     between ATryn and placebo treated subjects. In addition, the effect of ATryn on fetal and     neonatal clinical outcomes will be assessed. The PK characteristics of ATryn in the subjects     will be investigated by measuring AT activity levels in the mother during treatment and in     cord blood.   "
93739|NCT02059122|"     This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus     standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and     internationally.      The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early     stages of Dengue infection in patients with clinical symptoms consistent with Dengue     infection. This test is intended to be used on sera obtained within the first 7 days of     symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing     with a reference standard test.      Subjects will be patients who present with symptoms consistent with dengue infection, such as     fever and myalgia. After informed consent is obtained and the subject is screened for     eligibility, 2 diagnostic samples will be collected. The first will be collected within the     first 7 days of symptoms onset, and the second will be collected at least 7 days later,     between the 10th and 21st days post-onset of symptoms.      ELISA and reference tests will be performed by different operators who are laboratory staff     members. These staff members, blinded to each other's results, will evaluate the samples from     each method independently.   "
93758|NCT02058875|"     The overall goal of this study is to improve cardiovascular outcomes in transplant     recipients. The current standard immunosuppressive regimen in kidney transplant recipients     depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than     optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to     investigate the effects of reversing this paradigm. More specifically, the effect of using     maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or     Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.   "
93740|NCT02059109|"     The Belmont Rapid Infuser is a device currently approved to replace larger volumes of     necessary fluids such as blood in a fast and safe manner. The purpose of the study is to     evaluate proficiency and the retention of knowledge of how to use the device based on current     methods of training compared to revised training methods.      Hypotheses:        1. The use of the traditional method of training is not effective, predicting less then          half of staff will pass on the first attempt.        2. Restructured test with hands-on training as opposed to oral presentation only with a          written test will result in a pass rate of > 80%.        3. Staff members who work in pairs will perform better than working alone when setting up          the Belmont Rapid Infuser (BRI).        4. Retention at 3 months will be higher with the restructured training method than with the          traditional training method.   "
93741|NCT02059096|"     This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation     (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple     Sclerosis suffering from chronic pain of neurological origin.   "
93742|NCT02059083|"     The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in     adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary     outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for     cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number     of days used cannabis in the past 30 days).   "
93743|NCT02059070|"     Background: Outpatient continuous interscalene brachial plexus blocks are used to control     pain after shoulder surgery, with infusions of 0.125% bupivacaine or 0.2% ropivacaine. There     have been no studies comparing the effects of these two formulations. The major concern is     hemidiaphragmatic paresis, and since ropivacaine preferentially blocks sensory fibers, it may     cause less blockade of the phrenic nerve. This study was to evaluate the effects of     continuous interscalene brachial plexus infusions, with the hypothesis that respiratory     function is more affected by 0.125% bupivacaine than 0.2% ropivacaine, with equal effects on     pain relief.      Methods: All patients underwent baseline spirometry and ultrasound evaluation of     diaphragmatic excursion, followed by interscalene catheter placement for their surgery, then     randomized to receive a pump containing 0.2% ropivacaine or 0.125% bupivacaine. Patients     returned to the hospital the following day for spirometry, ultrasound reevaluation, and     evaluation of their pain level since discharge.   "
93744|NCT02059057|"     Crossover study for patients who were randomized to the Control Group in CLN0009.   "
93745|NCT02059044|"     One of the most common health care interventions in any healthcare setting is a medication     prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with     adverse drug events (ADEs). ADEs decrease patient health directly and can lead to     non-adherence, which in turn has negative consequences.      The investigators recently conducted a pilot project in which the feasibility and potential     utility of an information technology enabled outreach program for monitoring patients     receiving an outpatient prescription was tested. This intervention involved the use of an     interactive voice response system programmed to automatically call ambulatory care patients     following a prescription. If the system identified a potential medication problem, a     pharmacist was notified who contacted the patient, modified the therapy accordingly, and     informed a physician when necessary.      The pilot project included 568 patients with diverse illnesses in two Canadian cities. High     levels of patient and provider acceptability of the system were determined from 21 day     interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary     non-compliance events. Very few episodes of ameliorable ADEs were observed.      The investigators feel these results justify a randomized control trial to assess the     effectiveness of the intervention for improving patient centered outcomes. Ambulatory care     patients receiving incident prescriptions for one of four conditions (hypertension, diabetes     mellitus, depression, and anxiety) will be randomized to the intervention or routine care.     The investigators expect that the system will reduce the severity and duration of outpatient     ADEs and improve adherence to medication care.   "
93776|NCT02058641|"     This will be an exploratory, open-label, single sequence, two part study (Part A and an     optional Part B). The aim of this study will be to assess whether systemic inhibition of     Lipoprotein associated phospholipase A2 (Lp-PLA2) in humans, effected by 11 days of once     daily dosing to steady state with 160 milligrams (mg) of enteric coated (EC) darapladib, will     specifically reduce the number of macrophages and/or result in a higher proportion of M2     macrophages in skin blisters induced by cantharidin (a chemical agent that causes blisters).     In Part A of the study, a cohort of 8 subjects with type 2 diabetes mellitus will be     recruited. In Part B of the study, a cohort of 8 additional healthy subjects with matching     age (+/- 24 months) and gender to Part A may be recruited.   "
93746|NCT02059031|"     This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data     for selection of one of these tablet formulations for use in Phase 3. This is a     single-center, randomized, two part, open-label, crossover study in healthy adult subjects.     Part A is a randomized, open-label, 3-way balanced cross-over design in 24 subjects to assess     the oral bioavailability of two GSK1265744 sodium salt tablet formulations relative to the     current GSK1265744 sodium salt formulation being used in the phase IIb studies under fasting     conditions. Part A treatment periods will be separated by a 14 day washout. After completion     of Part A, preliminary PK data will be analyzed and a decision will be made based on     pre-specified criteria, as to which formulation will be used to conduct Part B. Fifteen     subjects who will have participated in Part A will participate in Part B and receive the     selected formulation with a moderate fat meal. All treatments will be administered as single     30 mg doses of GSK1265744. Safety evaluations and serial PK samples will be collected during     each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study     drug.   "
93747|NCT02059018|"     The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin     affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied     using the Dynamic Vessel Analyzer.   "
93759|NCT02058862|"     The purpose of this study is to determine if a home-based electrical stimulation (ES) program     is more effective than the standard of care (SOC) at improving quadriceps function,     functional outcomes, patient reported outcomes, and treatment compliance in patients     recovering from knee surgery. It is hypothesized that there will be significantly better     outcomes and compliance in ES group when compared to the SOC group.   "
93748|NCT02059005|"     This study will assess Specialized Community Disease Management (SCDM), an intervention which     employs various evidence-based strategies to engage substance using co-morbid patients while     in the hospital and follow them into the community via an empirically validated telephone     approach as well as contact with a trained community health worker peer specialist. The     investigators will first adapt and refine the core SCDM intervention with patient, provider,     and stakeholder input through an active community advisory board. The investigators will then     conduct a three-year, randomized controlled trial of 222 patients enrolled prior to hospital     discharge who are diagnosed with congestive heart failure, pneumonia, acute myocardial     infarction, chronic obstructive pulmonary disease, diabetes mellitus, or end-stage renal     disease, and a substance use disorder (SUD). Patients will be randomized to either the SCDM     intervention or Treatment as Usual (TAU), in which a team of nurse navigators and community     health workers follow patients (primarily by telephone) for 90 days post-discharge, but do     not address the specific needs of SUDs. The investigators will test the following four     hypotheses: (1) patients randomized to SCDM will demonstrate larger reductions in substance     use measured by urine-confirmed self-reported days using over the 6-month follow-up compared     to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty     substance abuse intervention and treatment sessions over the 6 month follow-up than patients     randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission     risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients     randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of     rehospitalization and use of acute emergency services than patients randomized to TAU.   "
93749|NCT02058992|"     The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem)     when used in the routine clinical setting in patients with sleep-onset difficulty associated     with insomnia.   "
93750|NCT02058979|"     Abstract The administration of an antibiotic preoperatively is an important intervention that     helps to reduce the risk of post-operative health-care associated infections (HCAI). These     include urinary tract, surgical site and blood stream infection. Based on the current     Surgical Infection Prevention Project, (SCIP) recommendations, the choice of the antibiotic     is based on the nature and site of the surgery and the presence of a β-lactam allergy (Table     1).      Currently, the antibiotic treatment for preventing surgical infections is administered as a     single bolus an hour before surgery, and every four hours after the initial dose. This     presents a concentration profile that has a high concentration after the bolus, but decays as     the kidneys remove the antibiotics. In this present study, investigators would like to     compare this traditional method of delivery to a constant infusion model that would sustain a     constant level of antibiotics that is defined by the difference between the rate of infusion     and rate of clearance.   "
93751|NCT02058966|"     Addiction to methamphetamine is a serious health problem. There are no medications that a     doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a     medication that could help people addicted to methamphetamine.      This study will see how entacapone works in healthy people who are given methamphetamine. We     think that the study drug will be well tolerated, and that it will prevent some of the     effects of methamphetamine that make it so addictive. We also want to see how differences in     people's genes may cause differences in the ways the study drug and methamphetamine work for     them.      The study has six total visits. The first visit is for screening. Tests and procedures will     make sure it is safe for subjects to participate.      The second visit is a familiarization day. Subjects will receive methamphetamine, but no     entacapone. This is done to make sure they can tolerate the drug and recognize its effects     before being given a second drug on the same day. Subjects will take surveys and computer     tests to see how the medications change mood, thinking, and liking the drug.      The final four visits are the actual study days. Subjects will be randomly assigned (like the     flip of a coin) to the different ways to get either 1) study medication or placebo (placebo     contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be     in all four groups during the study, which means that each day a subject will get a different     group.   "
93752|NCT02058953|"     The purpose of this study is to collect and bank samples of blood and tissues (such as brain     tissue or lymph nodes), as well as cerebrospinal fluid (CSF), which is the fluid that bathes     and cushions the spinal cord. The investigator will analyze DNA biomarkers in the samples.     The investigator hopes that by studying the biomarkers, he can develop tests in the future     that can detect central nervous system (CNS) metastasis in blood samples before they show up     on x-ray and develop medicines that can specifically target CNS metastasis.   "
93753|NCT02058940|"     The purpose of this study is to assess the feasibility of exenatide infusion for the     treatment of high blood sugars following acute brain injury.   "
93754|NCT02058927|"     This is an observational study of HIV-1 infected children starting antiretroviral therapy to     measure the magnitude and quality of general immune reconstitution and pathogen-specific     immune reconstitution to measles virus.   "
93755|NCT02058914|"     We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in     adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance,     triacylglycerol (TAG), and cholesterol concentrations.   "
93756|NCT02058901|"     The primary objective of this study is:        -  To determine the maximum tolerated dose (MTD) of sunitinib when administered once weekly          or once every two weeks.        -  To assess the safety and tolerability of sunitinib in a once weekly or once every two          weeks dose schedule.   "
93757|NCT02058888|"     The worldwide increase in the incidence of multidrug-resistant (MDR) pathogens is alarming.     Antimicrobial treatment is a risk factor for the isolation of MDR pathogens and can therefore     contribute to the observed trend. Differences in the degree of selection pressure caused by     various antimicrobials have not been systematically investigated until today. The aim of the     proposed project is the determination of the impact of antibiotic treatment on the copy     number of resistance genes in the human intestinal microbiome using metagenome shotgun     sequencing. The resistance gene count in the gastrointestinal tract will be determined in a     clinical cohorts of patients treated with either ciprofloxacin or cotrimoxazol as     monotherapy. The subsequent quantification and comparison of the selection pressure     facilitates the application of antibiotics with a lower potential to select for resistance.     To achieve this goal, a self-controlled, prospective observational epidemiological study will     be performed at two centres of the German Centre for Infection Research (Tübingen, Cologne).   "
93768|NCT02058745|"     This is a study to evaluate the effectiveness of using an established intervention for     depressive symptom management in conjunction with a needs-based caregiver intervention for     improving the psychological and physical health of family caregivers of persons recently     diagnosed with a Primary Malignant Brain Tumor.   "
93769|NCT02058732|"     Study the cervical spinal cord and brain over time to assess changes and differences in     subjects with amyotrophic lateral sclerosis.   "
93760|NCT02058849|"     The objective of the current proposal is to determine if concentrated beet root could improve     medical treatment compliance as defined by completion of radiotherapy and 3 cycles of     chemoradiation without dose reduction, preserve fat-free mass, and strength while reducing     mucositis. The investigators central hypothesis is that dietary nitrate supplementation in     head and neck cancer patients receiving aggressive medical care will improve compliance with     medical treatment by attenuating the loss of muscle mass and strength and reducing symptoms     (mucositis) associated with treatment compared to patients receiving standard care with     placebo.   "
93761|NCT02058836|"     The purpose of this research study is to determine if Botox injections will provide relief     from chronic testicular pain. In the study, the spermatic cord of particpants will be     injected with either Botox or a placebo of saline. Botox is currently used to treat other     urological conditions like overactive bladder and lower urinary tract problems. For these     conditions, Botox works by relaxing muscles in the affected areas. The investigators believe     that Botox will act similarly in the treatment chronic testicular pain.   "
93762|NCT02058823|"     The purpose of this study is to compare cardiovascular physiological adaptation to     intermittent hypoxia (IH) of nonobese healthy subjects. The exposure will be two periods of     two weeks (IH versus exposure placebo hypoxia). The investigators will use pharmacological     tools, peripheral vasodilator (amlodipine) or specific blocker of angiotensin receptor     (valsartan) versus the taking of a placebo. The allocation of the tool and the exhibition     will be randomized (HI / placebo, valsartan / amlodipine). The outcome measures evaluated     concern the cardiovascular system, systemic inflammation and tissular and glucose metabolism.      The investigators assume an increase in arterial resistance during the intermittent hypoxia     compared to the control group, these being dependent on sympathetic tone.      The investigators hypothesize that the metabolic alterations that will be observed after     experimental simulation (IH and fragmentation of sleep for 15 consecutive nights) will be     less severe in the valsartan group than in the amlodipine group in comparison with the     placebo group.      A serum bank and a gene bank will be performed for the requirements of subsequent studies if     necessary.   "
93763|NCT02058810|"     The pilot study aims to compare the results of using a new respirator (OPTIFLOW     TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of     patients who have been hospitalized due to acute heart failure. We expect a faster and more     effective stabilization after acute cardial decompensation among the patients with the     High-Flow-machine.      The study should show whether the use of High-Flow-Therapy leads to a relevant improvement in     terms of objective clinical parameters of heart failure like those for cardial-renal     syndrome, changes in the nt-pro-BNP, weight loss, changes in the diameter of the inferior     vena cava, in terms of the degree of shortness of breath and decompensation, and whether     subjective clinical symptoms like dyspnea and quality of life differ between the two groups     of patients.      The investigators see the primary outcome of the study as the improvement of the     cardial-renal syndrome as a sign of the more effective stabilisation compared to the standard     therapy. Furthermore, the investigators expect a quicker decrease in serum creatinine and an     improvement in the creatinine clearance through therapy with the High-Flow-Machine. In terms     of secondary outcomes of the study, the investigators are interested in also comparing e.g.,     the duration of hospital stays, 90-day mortality, and rehospitalisation within three months.     Here, the investigators expect a quicker improvement in the subjective shortness of breath of     the patients who are treated using the Hifh-Flow-Machine. Moreover, we believe that along     with the individual subjective improvements (quality of life survey), the patients will     experience a quicker release from the hospital and in this way, lead to a healthcare economic     improvement among patients with repeated hospitalizations who usually have chronic problems.      It is also of great interest to us, whether the biomarker BNP is an appropriate parameter for     determining the faster stabilization of the patient and whether the degree of improvement of     subjective dyspnea is correlated with the time needed until the patient has been stabilised.   "
93764|NCT02058797|"     The purpose of this study is to determine the efficacy of Coherence Therapy in treating     procrastination. For that, this intervention is compared to Cognitive-Behavioral Therapy     which was already proved to be efficacious in treating this problem. The method used is a     randomized controlled trial.   "
93765|NCT02058784|"     Open label study of Pracinostat will be tested to assess the effect of food on the     single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted     and fed conditions.   "
93777|NCT02058628|"     This is a randomized, comparator-controlled, single-blind, parallel-group study. The current     study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide     (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of     facial acne vulgaris. The results of the study will enable a better assessment of the safety     and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well     established treatment. Based on the data more evidence based recommendations will be possible     to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be     enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the     study will be over 12 weeks.   "
93766|NCT02058771|"     It is universally recognised that current methods for risk stratification of sudden cardiac     death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index     (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained     from a standard 12 lead ECG acquired during an invasive electrophysiological study.      In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified     subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%)     compared with those with an R2I2 <1.03 (11%) (P=0.004).      This study will use non-invasive techniques to acquire electrical restitution data: exercise     and pharmacological stress, and will incorporate body surface potential mapping to develop a     non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a     prospective, observational study.      HYPOTHESES:      PRIMARY:        1. R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.        2. The exercise stress protocol will create a dynamic range of heart rates that allows ECG          quantification of electrical restitution heterogeneity that correlates with invasive          R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a          dynamic range of heart rates that allows ECG based quantification of electrical          restitution heterogeneity that correlates with invasive R2I2 and is predictive of          VA/SCD.      SECONDARY:        1. A high-resolution electrical map acquired using body surface potential mapping will          correlate with R2I2 and these data can be included in the R2I2 calculation to improve          its prediction of SCD/VA.        2. Serial measurement of R2I2 will produce consistent values.   "
93767|NCT02058758|"     Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate     non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high     sensitivity because the intravenous MR contrast agent highlights regions with increased     vascularization and vascular permeability compared to normal breast tissues and benign     lesions.   "
93771|NCT02058706|"     This randomized phase II trial studies if enzalutamide added to standard luteinizing     hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate     cancer compared to the standard therapy of LHRH analogue and bicalutamide. Hormone therapies     stop the body from producing or block the effect of male sex hormones (testosterone).     Enzalutamide blocks the effect of male sex hormones which are responsible for the growth of     prostate cancer. Hormonal therapies that lower the level of testosterone are among the most     effective treatments for prostate cancer that have spread to other areas of the body     (metastasized). It is not yet known whether LHRH analogue therapy with bicalutamide is more     effective than LHRH analogue therapy with enzalutamide in treating prostate cancer.   "
93772|NCT02058693|"     In this Phase 4 trial we will study the safety, tolerability and efficacy of mixed salts     amphetamine (MSA), trade name Adderall, augmentation of antidepressant therapy for Major     Depressive Disorder (MDD) in depressed outpatient adults who are taking an antidepressant but     have not had complete resolution of their symptoms.      40 adult outpatients with MDD who failed at least one adequate trial of antidepressant     monotherapy will be consented in a 63-day, cross-sequential, multicenter study comprising two     treatment phases of 21 days each. The time frame from consent to baseline is 7 days. Patients     will receive placebo or MSA in Phase 1, and in Phase 2, participants will receive MSA. There     will also be a two-week follow up visit after the completion of Phase 2.      We hypothesize that MSA will be safe and well tolerated, and will improve the patient's     response to their antidepressant and provide superior symptom relief to antidepressant alone.     The primary outcome measure is the Massachusetts General Hospital Cognitive-Physical Function     Questionnaire (MGH-CPFQ).   "
93773|NCT02058680|"     This study is investigating the safety and efficacy of a vaccine directed against prostate     tumor cells. The researchers are interested in evaluating the safety and tolerability of the     vaccine, and the effects of the vaccine on survivability, time to measurable disease,     prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine.      Eligible patients include those with recurrent prostate cancer as shown by elevated levels of     PSA, although there is no evidence of tumors that are measurable by imaging studies. In     addition, to be eligible patients must have prostate cancer that either has not been treated     by hormonal therapy or is not responsive to hormonal therapy.   "
93774|NCT02058667|"     The purpose of this trial in addition to a dose finding study for concurrent Paclitaxel, will     be to establish a treatment algorithm for chest wall reirradiation. A nominal margin of at     least 5cm will be used on the protocol and extending it to 7cm. Considering the standard     treatment of breast cancer incorporates a cumulative dose of 60Gy, delivering an additional     50.4 Gy followed by a boost should target a total dose of 120 Gy.   "
93775|NCT02058654|"     This study will examine the impact of creatine supplementation on muscle function and     cognitive performance in young and older subjects.   "
93778|NCT02058615|"     Male partners of women with breast cancer experience distress, so we want to develop a way to     support them so they, in turn, can care for their wives. The purpose is to pilot test an     online male spouse transition toolkit (MaTT) that the research team has developed. The     specific aims are to: a) evaluate the Toolkit for ease of use, acceptability, and     feasibility, and; b) collect preliminary data to determine potential effectiveness of the     Toolkit in increasing hope, general self-efficacy and quality of life, and its potential     effectiveness in decreasing guilt scores for male partners of women with breast cancer     (stages 1-3).   "
93779|NCT02058602|"     This is a clinical study to characterise the lung function, airway morphometry, pharyngometry     and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF)     over a period of up to 6 months. Inhalation profiles will be recorded from patients with IPF     as they inhale during tidal breathing, and following two sets of instructions (maximal effort     and 'long, steady and deep' inhalation), across a range of airflow resistances that reflect     those of typical inhalers used to deliver medication to the lungs. Mouth and throat     dimensions will be measured using an acoustic reflectance Pharyngometer. Measurements of lung     function will be made using conventional sprirometry, plethysmography and diffusion, whilst     Low Dose High Resolution Computed Tomography (HRCT) will be used to scan the airways at two     lung volumes; functional residual capacity (FRC) and total lung capacity (TLC). Data from     HRCT will be used to reconstruct airway morphometry, and model inhaled particle deposition     within the lung. Overall, the study allows a further understanding of the IPF patient     population, using the data to assist in the development of new inhaled products for this     disease. Following up the patients with additional HRCT scans at 3 and 6 months will enable     the sensitivity of CT based criteria of disease progression to be compared with lung function     criteria. No investigational product will be used in this study.   "
93780|NCT02058589|"     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or     older who are receiving chronic immunosuppressive therapy.   "
93781|NCT02058576|"     The purpose of this study is to assess the bioequivalence of the second generation     dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available     commercial combination of dutasteride 0.5 milligrams (mg) and tamsulosin HCL 0.4 mg capsule     in healthy adult male subjects. Subjects in this study will receive either a single oral dose     of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a     single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL     0.4 mg capsule followed by a 28-day washout period both in fed state. The study will enroll     approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable     subjects. The total duration of a subject's involvement in this study is anticipated to be     approximately 12 weeks.   "
93782|NCT02058563|"     The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR     (Priorix®), comparing it to Mercks MMR vaccine (M-M-R®II), which is approved for use in the     US.   "
93783|NCT02058550|"     This randomized, pilot phase I trial studies whether phone or email reminders increases     vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they     undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive     material placed directly into or near a tumor to kill tumor cells. A reminder program may     help increase use of vaginal dilators and decrease long-term side effects following     brachytherapy.   "
93785|NCT02058524|"     The investigators are conducting an open-label study of fecal microbiota transplantation     (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot     study the investigators will evaluate the feasibility, safety, and tolerability of a single     application of FMT delivered colonoscopically. The investigators will also characterize the     impact of FMT on the microbiota of the recipient and determine if it correlates with the     microbiota from the FMT donor.   "
93786|NCT02058511|"     The study comprises of a series of pupillary measurements using infrared pupillometry in     patients undergoing arthroscopic knee surgery of any type.      Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary     reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is.     This may help to predict the amount of discomfort a patient will be experiencing after     emergence from general anesthesia.      In addition to measuring the pupillary reflex dilation, we will also measure oscillations of     pupil size before and after indiction of anesthesia, as well as during recovery. These     spontaneously occuring oscillations in pupil size, also called hippus, appear to be sensitive     to anesthetics and opioids. However, the effect of these drugs on hippus has not been     systematically addressed.      The aim of the study is        1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve          blocks will block the PRD. This would allow assessment of block success in the          anesthetized patient.        2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized          patient during and at the end of surgery with early postoperative pain scores and          subsequent analgesia requirements. Such correlation would allow to predict the amount of          postoperative pain before the patients emerge from general anesthesia.   "
93787|NCT02058498|"     Will adult liver transplant patients who are provided with physical activity (walking)     instructions increase their physical activity and perceive an improved quality of life?   "
93788|NCT02058485|"     Hypertensive patients' often severe hypotensive response after induction of anesthesia and     excessive increase in blood pressure to stresses such as laryngoscopy, intubation, surgical     incision and extubation. There are many publications in the literature of preoperative     evaluation of patients with hypertension and perioperative treatment of hypertension but is     not sufficient about anesthetic management of these patients. Purpose of our study, was to     investigate the haemodynamic effects of dexmedetomidine and midazolam used for premedication     in hypertensive patients relative to each other and according to the normotensive patients.   "
93789|NCT02058472|"     Study Design : randomized, open label, single-dose, 2-way cross-over design      Phase : Phase I   "
93791|NCT02058446|"     The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in     worldwide populations including Asian patients. The study primarily aims to evaluate the     effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in     Taiwan using a prospective, open-label, non-randomized approach.      The study also wants to investigate the safety of Amlodipine/Valsartan combination during the     6-week treatment period.   "
93792|NCT02058433|"     Platinum-based doublets including paclitaxel, gemcitabine, or docetaxel are standard 1st     regimens in Non-Small Cell Lung Cancer(NSCLC). The traditional method of individualizing     cytotoxic drug dose is by using body surface area(BSA), which is not correlated with the     ability of an individual to metabolize or excrete cytotoxic drugs, because it is not related     to liver function and is poorly correlated with glomerular filtration rate, and does not seem     to be a determinant of toxicity. Pharmacokinetic parameters such as area under the curve have     been shown to correlate with toxicity. The advantages of using a fixed dose of antineoplastic     agents for all of the patients are obvious. Pharmacokinetically guided treatment would avoid     severe adverse effects, which has not been sufficiently investigated in advanced NSCLC.First,     the investigators monitor the blood concentrations of paclitaxel and neutropenia blood     toxicity after chemotherapy with paclitaxel and carboplatin in patients of NSCLC and verify     suitable paclitaxel therapeutic window for Chinese patients. Then the investigators compare     safety and efficacy between individual paclitaxel dose adjustment based on the therapeutic     window compared with conventional dosage.   "
93793|NCT02058420|"     Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance     for bone fractures. Women are 4 times more likely to have osteoporosis than men because there     is no estrogen protection after menopause and women in general have lighter and thinner     bones. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be     good for the bone health in postmenopausal women. However, no study has ever been done the     role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop     a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss     in postmenopausal women. The purpose of the study is to examine the effect of 12-week     tocotrienols on bone measurements in postmenopausal women. Investigators plan to recruit     postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local     radio, newspapers, and TV scripts. We plan to enroll approximately 200 women to obtain 78     qualified women at the start of the study. After screening, qualified participants will be     matched by body weight and age, and then randomly assigned to no tocotrienols, low     tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline,     after 6, and after 12 weeks. Bone-related measurements will be recorded using blood and urine     samples. Investigators will monitor safety of subjects after 6 and after 12 weeks. Food     intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All     data will be analyzed statistically.   "
93817|NCT02058108|"     The purpose of the study is to assess the efficacy and safety of telbivudine at a dose of 20     mg/kg up to a maximum of 600 mg q.d. in compensated pediatric HBeAg-positive and negative CHB     patients aged 2 to <18 years with the indication of antiviral CHB treatment. This study is     part of the commitments of the pediatric development plan for telbivudine in Europe and US.   "
93818|NCT02058095|"     To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo     on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral     response to acute sodium loading in subjects with preclinical Diastolic dysfunction (PDD) and     renal (kidney) dysfunction   "
93819|NCT02058082|"     The purpose of this study is to determine whether couples undergoing IVF/ICSI with male     factor infertility, specifically with elevated sperm DNA damage, should testicular sperm     extraction be utilized to improve their reproductive outcomes.   "
93794|NCT02058407|"     This study is the first administration of GSK2793660 to humans and will evaluate the safety,     tolerability, PK and PD of single oral ascending doses of GSK2793660, and of repeat oral     doses of GSK2793660 in healthy subjects. The study will comprise two parts (Part A and Part     B). Part A will consist of two cohorts of subjects, each taking part in a three-way cross     over study, with ascending doses of GSK2793660 and placebo. Available safety, PK and PD data     will be reviewed before each dose escalation. This will be followed by a food-effect arm in     the cohort that received what is deemed to be the target clinical dose. Part B is planned to     consist of up to two cohorts of subjects, each taking part in one 14 day repeat dose study     period. Subjects will be dosed on Day 1 and then on Days 3-15. It is planned that two doses     will be evaluated. The dose(s) to be tested will be selected based on safety, PK, and PD from     Part A. The study is intended to provide sufficient confidence in the safety profile of the     molecule and information on target engagement to allow progression to further studies.   "
93795|NCT02058394|"     The purpose of this study is to investigate postoperative events in patients noted to have     retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in     those who did not.   "
93796|NCT02058381|"     Based on the evidence acquired in the post-menopausal setting with everolimus and on     pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and     buparlisib, in combination with endocrine therapy in hormone receptor-positive MBC, the     purpose of this phase Ib trial is to assess the maximum tolerated dose (MTD) and/or the     RP2D(s), to characterize the safety and tolerability, to determine the single and multiple     dose PK profile and assess the preliminary anti-tumor activity of alpelisib and buparlisib in     combination with tamoxifen plus goserelin acetate in premenopausal hormone receptor-positive     advanced breast cancer patientsgroup.   "
93797|NCT02058368|"     This is a multicentre, randomised, double-blind, parallel group study in Asian subjects. The     aim of the study is to investigate whether combination therapy with dutasteride and     tamsulosin is more effective than tamsulosin monotherapy for the improvement of symptoms and     health outcomes in an at risk population of benign prostatic hyperplasia (BPH) clinical     progression including older men (>=50 years), with moderate-severe symptoms of BPH, enlarged     prostates (>=30 cubicentimeter [cc]) and prostate specific antigen (PSA) >= 1.5 nanograms per     milliliter (ng/mL). Each subject who met the eligibility criteria at screening will enter a     four-week single-blind, placebo run-in period following which each subject will be randomised     into a 2 year double-blind treatment phase. The total study duration for each subject will be     up to 110 weeks.   "
93798|NCT02058355|"     This project aims to develop and evaluate the effectiveness of an Personalized Normative     Feedback (PNF) intervention via the internet, through a randomized clinical trial for alcohol     consumption among Brazilian college students, as well as evaluating the most effective     components of the PNF (normative and list of consequences). The sample is composed of college     students aged between 18 and 30 years. Participants allocated into four different groups:     control, full intervention (PNF), feedback with normative components (FN) and feedback with     list of consequences (FLC). The investigators will use the dismantling design to study the     most effective components. Participants will be followed-up at 1, 3 and 6 months.   "
94302|NCT02051751|"     Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis     when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety     and tolerability of the BYL719 and paclitaxel combination   "
93799|NCT02058342|"     Compared to other children, those with disability have additional challenges to being     physically active. Prader-Willi Syndrome (PWS) is a genetic form of childhood obesity that is     characterized by hypotonia, growth hormone deficiency, behavioral, and cognitive disability.     In children, the low prevalence of PWS (1 in 10,000 to 15,000 live births) makes group-based     physical activity (PA) interventions impossible. In contrast, the home environment presents a     natural venue to establish a PA routine for this population. The present high prevalence of     non-syndromal childhood obesity (one in four) and high physical inactivity rates, make     alternative approaches to increasing PA in this population an area of high interest.     Therefore, we have developed a 24-week home-based physical activity that could be suitable     for children and adolescents ages 8-15 with PWS as well as obese children without PWS ages     8-11 years. It is hypothesized that: 1) an age-appropriate 24-week home-based PA intervention     will increase PA levels in youth with PWS and without the syndrome but with obesity; 2) motor     proficiency, central sensory reception and integration, and body composition will     significantly improve in youth with and without PWS following completion of the home-based PA     intervention and 3) physical activity self-efficacy and quality of life will increase     significantly in youth with and without PWS who complete the home-based PA intervention. The     study participants are 115 youth ages 8-15 y (45 with PWS and 70 without PWS but categorized     as obese). The study utilizes a parallel design with the wait-listed control group receiving     the intervention after serving as control. Participants are expected to complete the PA     curriculum 4 days a week for six months including playground games 2 days a week and     interactive console games 2 days a week. Parents are trained at baseline and then provided     with a PA curriculum (Active Play at Home) and equipment to guide their implementation of the     program at home. Measurements of children and parent dyads are assessed at baseline and at     the end (week 24) of the intervention or control periods. Outcome measures include PA, body     composition, motor proficiency, central sensory reception and integration (subsample of     children only), quality of life and physical activity self-efficacy. PA intervention     compliance is monitored using mail-in daily self-report checklists.   "
93800|NCT02058329|"     The overall goal of the project is to reduce the incidence of post hip fracture morbidity and     mortality by conducting geriatric fellow periodic home visits.The assessment will be     multidisciplinary and will include assessments of functional status, depression,     environmental risks and medical conditions. This group will be compared against a group     followed by the usual standard of care post hip fracture.   "
93801|NCT02058316|"     Background Invasive pulmonary aspergillosis (IPA) remains an important cause of morbidity and     mortality among patients with hemato-oncological malignancies. Due to the crude mortality of     >90% in absence of adequate treatment, timely diagnosis and early start of antifungal therapy     are key factors in the successful treatment of IPA. Various studies have shown that early     initiation of antifungal therapy may improve IPA survival to above 70%. Diagnosis of IPA,     however, remains difficult as clinical signs and symptoms as well as radiological findings     are often unspecific and conventional culture methods lack sensitivity. In recent years     antigen testing has therefore become one of the cornerstones of IPA diagnostics.     Brochoalveolar lavage (BAL) Galactomannan (GM) testing is currently the most promising     approach for early detection of pulmonary infections by this fungus. However, limitations of     GM detection are assay turn-around time, which varies widely between centers (less than a day     to several days), and the need for appropriately equipped laboratories that routinely test     for this antigen. These limitations are overcome by the Aspergillus Lateral-Flow Device     (LFD), a novel point-of-care (POC) test for IPA diagnosis developed by Dr Thornton at the     University of Exeter, UK. This simple, rapid (15 min), single-use test can be performed in     rudimentary facilities using BAL specimens. In a retrospective single centre study we have     recently evaluated the LFD test in 39 BAL samples from hematologic malignancy patients and     solid organ transplant recipients. Sensitivities and specificities of BAL LFD tests for     probable IPA were 100% and 81%, respectively. Galactomannan levels in cases with negative LFD     were significantly lower than in patients with positive LFD (P <0.0001). We concluded that     the LFD test of BAL specimens is performed easily and provides accurate and rapidly available     results. Therefore, this new point-of-care test may be a very promising diagnostic approach     for detecting IPA in BAL specimens from haematological malignancy and SOT patients. For     routine clinical use, however, multicenter studies with larger sample sizes also from other     patient collectives are necessary. In this multicenter study we will evaluate the LFD test in     BAL samples.      Study Objectives Primary Objectives To evaluate the Lateral Flow Device test, a rapid (15     min), point-of-care test for IPA diagnosis using bronchoalveolar lavage (BAL) fluids from     patients at risk for IPA.      Secondary Objective To evaluate the potential of BAL Lateral Flow Device test for prognosis     in patients with IPA.      Study Design This is a prospective multi-center study conducted in three centers in Austria     (Graz, Vienna and Innsbruck) and one centre in Germany (Mannheim). In order to meet the     objectives an estimated number of 300 BAL samples from patients at risk for IPA (50 to 100     per centre) will be included in the study cohort. The Lateral Flow Device test will be     performed prospectively in BAL samples from the patients and results will be compared to GM     results, PCR findings, clinical/radiological findings as well as conventional culture     results. In addition, retrospective testing of BAL samples that were previously routinely     tested for GM will be performed in up to three participating centers (Graz, Innsbruck and     Mannheim) to ensure to reach the proposed number of 300 BAL samples. The treating clinicians     will not be informed about BAL Lateral Flow Device test results and the test will therefore     have no impact on patient management / treatment decisions.   "
93802|NCT02058303|"     The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a     shorter-acting nerve block to a traditional single-shot nerve block in patients having hand,     wrist or finger surgery.   "
93803|NCT02058290|"     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome     injectable suspension) to determine if total opioid consumption is reduced when using     EXPAREL, therefore possibly reducing total hospital costs.   "
93804|NCT02058277|"     This is an open label, randomized, single dose, one cohort, two sequence, two period     crossover study in healthy subjects. The primary objective of the study is to evaluate the     effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single     oral dose of bosutinib in healthy subjects.   "
93805|NCT02058264|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.   "
94096|NCT02054442|"     The investigators will perform a randomized phase II study to investigate if the addition of     cetuximab to MTX is beneficial for the patient. Because no data on this combination are     available the investigators will start with a phase Ib study to investigate the feasibility     of the schedule.   "
93806|NCT02058251|"     In comparison to the general population, military personnel and veterans are at increased     risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder     (PTSD). Despite promising developments in the past decade, the treatment of patients with     SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al.,     2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term     negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation     (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or     systemic OT administration decreases activation of the amygdala in response to visual     fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful     events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville     and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little     attention has been focused on whether OT decreases SUD vulnerability after exposure to     traumatic stress in preclinical or clinical studies. This clinical project will determine     whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and     decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier     Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.   "
93807|NCT02058238|"     To quantify potential short- and long-term benefits of robotically-guided minimally invasive     (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal     instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a     matching cohort of control patients, performed using a freehand technique, both in MIS and     open approaches.   "
93808|NCT02058225|"     The purpose is to study the effect of infant nutrition on brain development, as measured     using Magnetic Resonance (MR) techniques. The investigators will collect detailed information     about the diet of each of the infants, and seek to correlate this information with multiple     MR measurements, including structural imaging, diffusion imaging, and functional     connectivity. The MR scans will be performed at birth and 3 months of age. Dietary     information collected will include detailed food diaries describing the feeding habits of the     infants, and food frequency questionnaires to characterize the diet of the mother.   "
93809|NCT02058212|"     ROS plays an essential role in the pathogenesis of many reproductive processes. High     follicular fluid ROS levels are associated with negative IVF outcomes.      is plasma level of reactive oxygen species is affected by antioxidant treatment in     endometriotic women?   "
93810|NCT02058199|"     The investigators are attempting to compare the anticoagulant (blood thinning) effects of a     recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass     surgery to people who have not had this surgery. It is thought that gastric bypass may alter     the absorption of this medication, but this has not been previously studied.      The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers     who are in one of four groups        1. Non obese people who have not had a gastric bypass.        2. Obese people who have not had a gastric bypass        3. People who have had a gastric bypass        4. People who are planning to undergo gastric bypass surgery in the near future who are          willing to be studied before and after the bypass.      The study will involve taking a single low dose of rivaroxaban and multiple blood samples     will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be     measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban     will be compared between the different groups.   "
94303|NCT02051738|"     The purpose of the study is to evaluate the effect of food on the bioavailability (how much     medication is in your blood) of mebendazole from a single 500 mg oral dose of a     fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.   "
93811|NCT02058186|"     Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic     dermatitis patients (AD) resulted from the reduction of cathelicidin production in these     patients plays the important role in pathogenesis of this disease. Recently in vivo study has     showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin D     might be beneficial in atopic dermatitis.      Objective: To determine the effect of oral vitamin D supplement on clinical impact including     skin colonization of S. aureus in atopic dermatitis patients.   "
93812|NCT02058173|"     The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for     treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with     confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg     daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have     receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to     study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are     pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of     therapy (12 weeks) and at baseline, first, second and third month after receiving drug and     placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared     between groups.   "
93813|NCT02058160|"     Primary Objective:      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination     (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.      Secondary Objective:      To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin     glargine (with or without metformin) over a 30 week treatment period in participants with     type 2 diabetes.   "
93814|NCT02058147|"     Primary Objective:      To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone     and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c)     change from baseline to Week 30.      Secondary Objective:      To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio     combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin     treatment) over a 30 week treatment period in participants with type 2 diabetes.   "
93815|NCT02058134|"     The purpose of this study is to determine whether intra- and postoperative use of the     cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in     patients, who undergo open heart surgery (with cardiopulmonary bypass) and preoperatively     have an increased risk for bleeding.   "
93816|NCT02058121|"     The purpose of this study is to test if an ACT group intervention focusing on body image     enhances recovery and reduces relapse in patients treated at a specialised eating disorder     unit.   "
93820|NCT02058069|"     The Investigation will be conducted as a single-submission, multi-center study with approval     from and in compliance of the Western Institutional Review Board (WIRB).      The overall objective of this Investigation is to assess the safety and effectiveness of the     Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application.     Specifically, the study objectives are classified as follows:        -  Primary Objective: Surgeon assessment of standardized TKA complications both          intra-operatively and at short term follow up.        -  Secondary Objective: Radiographic assessment of post-operative limb alignment.        -  Supporting Objective: Patient assessment of post-operative function and satisfaction.   "
93821|NCT02058056|"     The main objective of this trial is to assess NCF after early HA-PCI concomitant to the     second cycle of CHT and to tRT for patients with LD SCLC.   "
93822|NCT02058043|"     DESCRIPTION OF RELATED QUESTION Cognitive disorders are frequently encountered and present a     major public health problem given the aging of the population.      There is not one, but several neurodegenerative pathologies individual differentiated.      Particularly distinguished is Alzheimer's disease (the most common), dementia lobar     fronto-temporal associated with semantic dementia (a disease with a particular tropism for     semantic memory and the anterior temporal lobe), and dementia with Lewy bodies.      To differentiate these pathologies is, for the clinician, is a major issue and the clinic may     not be enough.      The management and current diagnostics of atypical cognitive disorders, that is to say,     patients with clinical symptoms or neuropsychological testing results suggestive of a     neurodegenerative disorder other than Alzheimer's disease, are based largely on data imaging.      In the first intention, conducting imaging by MRI is recommended by the HAS, particularly to     search for treatable causes to these cognitive disorders (tumors, intracranial hemorrhage in     particular) but also to study the distribution of cerebral atrophy.      The sequences used are the sequences 3D T1, axial Flair, gradient echo axial T2 and coronal     T2 in the plane of hippocampi and also diffusion imaging.      Research has shown interest in the study of cerebral perfusion in cognitive disorders.      The HAS recommends not to inject contrast medium on MRI in this context. The sequence of     perfusion by tagging arterial protons or arterial spin labeling (ASL) does not use     exogenous contrast medium. This is available as a commercial product, CE marked, on most of     the recent clinical MRI scanners. This non-invasive technique, requiring no special     precautions (e.g. verification of renal function) is used in routine clinical practice at the     University Hospital of Rennes and in many centers. In the imaging of patients with dementia,     it is widely used as well as the 3D T1 sequences or diffusion imaging (International     Initiative ADNI) and is subject to optimization and harmonization of use in routine clinical     practice with the European COST AID actions.      The second intention, an isotope imaging by FDG-PET or study of perfusion SPECT can also be     performed. The interest of isotopic imaging (FDG-PET and SPECT) lies in the provision of     information metabolic nonexistent in MRI, with a superiority of FDG-PET compared with SPECT.     FDG-PET is the preferred examination and is carried out at CRLCC Eugène Marquis de Rennes in     this context.      The aim of our study is to compare the imaging of TEPFDG, a technique not morphological, and     ASL that, even if they do not study the same mode (metabolism for the first and perfusion for     the second) may depict consistent anomalies.   "
93823|NCT02058030|"     Background - The purpose of the present study is to evaluate the success and pharyngeal     trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway     insertion      Methods      - This prospective randomized, controlled study included 80 adult patients . In the 3 cm     (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6     cm height of pillow. The success rate at first and second attempt, insertion time, blood     staining on cuff, sore throat and hoarseness were assessed.   "
93824|NCT02058017|"     This is a lead-in dose escalation study to determine the safety, tolerability,     pharmacokinetics, maximum tolerated dose (MTD), and recommended Phase II dose of OPB-51602     administered on a weekly basis in subjects with advanced malignancies. Using the recommended     phase II dose, the efficacy and tolerability of OPB-51602 administered prior to definitive     chemoradiotherapy will be evaluated in locally advanced NPC patients. This study's     overarching goal is the development of STAT3 inhibitors as a novel class of anti-cancer     agents and the optimization of patient selection for STAT3 inhibitor therapy through parallel     biomarker studies. This study hopes to establish a therapeutic window for OPB-51602 in solid     tumours and will evaluate its potential as a targeted therapy of NPC, since this represents a     critical unmet clinical need. The development of predictive and pharmacodynamic biomarkers in     tandem with the clinical evaluation of OPB-51602 will be crucial to its therapeutic     advancement and will enable an understanding of the genetic contexts of responsiveness and     resistance to OPB-51602, which can in turn lead to the development of effective drug     combinations to overcome resistance.The study hypothesizes that OPB-51602, a first-in-class     STAT3 inhibitor, is efficacious in solid tumours with constitutively activated STAT3, such as     NPC.   "
93825|NCT02058004|"     In modern anesthesia practice, the application of cricoid pressure during intubation is not     infrequently used with the goal of preventing gastric-to-pulmonary aspiration. The evidence     to support this practice is very scarce, and there have recently been many reports in the     literature questioning the safety of cricoid pressure during intubation. Therefore, the goal     of this study will be to randomize those at risk for microaspiration to receive cricoid     pressure versus no cricoid pressure during intubation. We will specifically exclude those     patients thought to be at the highest risk of aspiration (it is considered standard of care     to perform cricoid pressure during intubation of this population). We will include those     patients with some risk factors for aspiration (it is not considered standard of care to     apply cricoid pressure during intubation of this population).   "
93826|NCT02057991|"     This randomized pilot trial studies mindfulness-based program in educating patients with     colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce     stress and fatigue in patients with colorectal cancer and their caregivers.   "
93827|NCT02057978|"     The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES     compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.   "
93828|NCT02057965|"     This study will test the hypothesis that MSCs in combination with Everolimus facilitate     Tacrolimus withdrawal, reduce fibrosis and decrease the incidence of opportunistic infections     compared to standard tacrolimus dose.   "
93841|NCT02057796|"     In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections     are leading causes of early death in patients who initiate antiretroviral therapy (ART) with     advanced immunodeficiency.      We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the     introduction of ART in HIV-infected adults with severe immunosuppression (CD4<100/mm3) and no     overt evidence of TB will reduce the risk of death and invasive bacterial infections. This     strategy will be compared to one of extensive TB testing using point-of-care tests (Xpert     MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only patients     with at least one positive test suggestive of TB.   "
93842|NCT02057783|"     Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a     physical activity program will optimize 24-hour blood pressure control in patients with     OSA-related resistant hypertension.   "
93829|NCT02057952|"     The main objective for this project is to identify effective methods of treating obesity in     at-risk populations. The investigators will be comparing weight loss from usual care, in     person, and video conference weight loss programs. The investigators will follow 210     participants for 12 months to see if they lose and maintain 2kg of weight. The investigators     will also compare the costs of video conference versus in person administered programs.      Potentially eligible participants will be identified based on data in the Regenstrief Medical     Records System or by referral from the Wishard HealthyMe weight loss program staff or a     Wishard Community Health Center (CHC) primary care provider. The PBRN staff will carry-out     initial recruitment. Following consent, a baseline assessment will be performed and each     participant will be randomized into one of three groups: usual care control, in person weight     loss or online video conference weight loss. At 6 and 12 months a follow up assessment will     be performed and compared to measures from the investigators baseline assessment. Total costs     for each program will be compared as well.      The weight loss interventions involve group meetings two times per week where education,     exercise, and social support are provided. Participants will also receive a detailed     education booklet. Those randomized to the in-person group will meet in the CHC and those in     the video-conference group will meet online in a multi-party video-conference. All     participants will receive usual CHC care.   "
93830|NCT02057939|"     The purpose of this study is to describe the 2 year progression-free survival in men with     recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard     androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have     recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in     the absence of metastatic disease on CT and bone scans. In addition to standard ADT and     radiation therapy, research participants will take enzalutamide once daily for six months. It     is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy     compared to the historical control data in a similar patients setting.   "
93831|NCT02057926|"     The main objective of this study was to evaluate the histological impact of treatment with     tetracycline (TTC) solution of two layers collagen membranes (CMs) bio-degradation, in ridge     preservation technique (RPT). Additionally, secondary objectives were to evaluate the effect     of TTC on bacterial colonization and inflammatory response. This is a randomized simple-blind     clinical trial. Consecutive patients referred to the Department of Periodontology at     Universitat Internacional de Catalunya (Barcelona, Spain), between November 2009 and April     2011, were included in the study. This study was based on data collected from 20 surgical     sites in 10 systemically healthy patients requiring 2 extractions with SPT. Before starting     the surgery, the two teeth of each selected patient were randomized in two groups. The test     group underwent RPT with CMs embedded with TTC solution (CMs TTC), and the control group was     performed without TTC solution (CMs NO TTC). Randomization was performed using SPSS software     (version 18, SPSS Inc., Chicago, IL, USA). In the test group, both membranes were first     dipped for 5 minutes in TTC solution (50 mg/ml). This involved the use of 250 mg tablets of     TTC and 5 ml of saline that were mixed in a sterile trough. A sample of the membrane used in     each SPT was retained as a negative control sample. The membrane sample was retrieved 7 days     after initial surgery. At 14 days the suture was removed and a new control was performed     within 1 month. A sample from the negative control, test and control group was analyzed from     each patient. The specimens were fixed in a 10% formalin solution, dehydrated in a series of     alcohols, embedded in paraffin, and sectioned in 4-5μ. The sections were stained with     hematoxylin and eosin and examined with an Olympus BH-2 optical microscope. The stained     sections were photographed with a digital camera mounted on an optical microscope at     magnification (x100, x200 and x400). According to the findings of the present study, we can     conclude that CMs exhibit rapid degradation when exposed to the oral environment.     Histological interpretation suggests that CMs immersed in 50mg/ml TTC solution delay the CM     degradation when exposed to the oral environment. Statistical evaluation did not show any     difference in bacterial colonization and inflammatory response, but the findings may also be     affected by the limited sample size.      The limits of the present study are the absence of histomorphometric analysis, the sample     size, and the lack of a long-term evaluation with clinical evidence of the advantages of this     technique. More clinical studies in humans are require to confirm the effect of TTC in CMs     degradation before we can make recommendations.   "
93832|NCT02057913|"     VinCaP is a multicentre single-arm phase II trial. 22 patients will receive Vinflunine     chemotherapy (Vinflunine 320mg/m2 given intravenously on day 1 of each cycle of 21 days, four     cycles to be given prior to formal re-staging).   "
93835|NCT02057874|"     This pilot clinical trial examines how well different imaging biomarkers acquired using     3-Telsa magnetic resonance imaging (MRI) methods perform in determining treatment response to     transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma. Compared to     conventional imaging, multi-parametric 3-Tesla MRI offers the ability to quantitatively     measure tissue structural, functional, cellular, and molecular properties, providing a more     robust, clinically relevant method for assessing cancer response to therapy.   "
93836|NCT02057861|"     In this study the investigators aimed to compare the time of antagonism and intensity of     effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic     patients.   "
93837|NCT02057848|"     Backgrounds/Aims: It was the aim to prospectively study the optimum regime of preventive     carbohydrate administration for prevention of hypoglycaemic episodes during a standardized     bout of physical activity.   "
93838|NCT02057835|"     BI 691751 is currently being developed to inhibit growth and prevent rupture of     atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in     patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to     investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and     Japanese male volunteers.   "
93839|NCT02057822|"     The ocular surface may be the seat of an inflammatory process in many pathology as vernal     keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells     themselves and the constituent cells of the target organ, are the main factors that cause     inflammation. The main objective of our study was to compare the concentration of 40     cytokines in vernal keratoconjunctivitis and in control subjects.   "
93840|NCT02057809|"     Developmental disability is a severe chronic disabled condition caused by mental or physical     impairments. Children with developmental disabilities may face life-long difficulties in     motor functioning, self-care, condition, communication, and independent living. They often     receive rehabilitation services to promote daily functions and participation in home, school,     and community lives.      Family-centered service has been considered as best practice in pediatric rehabilitation.     Therapists encourage children with developmental disabilities and their parents to     participate in decision making and implementing process of intervention, and provide     intervention plan that best fit their family needs. Research shows that for children with     developmental disabilities, family-centered services can enhance children's development,     decrease parenting stress, promote emotional wellness, and increase parental satisfaction to     services. Though the family-centered concept has been considered as relevant in pediatric     rehabilitation, there are still difficulties, as well as a lack of evidence regarding its     implementation in practice.      Reflecting the trend of family-centered medical care, the benefits of national health     insurance in Taiwan for early intervention outpatient care will emphasize on family-centered     intervention. The range of benefits may include communication with parents, parental     education, consultation and instructions for home programs. Besides, outcomes of     family-centered intervention will be treated as an important index for monitoring the quality     of medical services.      Given that there is a lack of investigation regarding the family-centered pediatric     rehabilitation, the purposes of this one-year research project are to investigate the     implementation of family-centered pediatric rehabilitation for children with developmental     disabilities and to identify related influencing factors. This study will provide empirical     evidence for family-centered services in Taiwan.   "
93843|NCT02057770|"     The purpose of this research study is to look at overall health status and how acute myeloid     leukemia (AML) responds to a stem cell transplant when followed with cyclophosphamide. Some     participants enrolling in this study may receive a transplant from a sibling, some may     receive a transplant from a matched unrelated donor, and some may receive what is called a     haploidentical transplant. A haploidentical stem cell transplant is a type of transplant that     occurs when a person who needs a transplant cannot find a donor who exactly matches their     tissue type (either among family members or through a matched unrelated donor). When no     matched donor is available, half-matched related (haploidentical) donors may be used.     Haploidentical donors are first degree relatives such as siblings, children, or parents.      People who undergo a stem cell transplant can experience complications such as rejection of     the stem cell transplant or severe graft-versus-host disease (GVHD). GVHD occurs when some of     the cells from the donor attack the recipient's tissues, resulting in mild, moderate, or even     life-threatening side effects to the recipient's skin, stomach, intestines, and liver.     However, recent research has shown that receiving cyclophosphamide after stem cell transplant     can improve the outcomes of the transplant, and that is the purpose of this study.   "
93844|NCT02057757|"     Respiratory viruses are a significant cause of hospitalization for respiratory tract     infections. This study will evaluate the safety, effectiveness, and tolerability of     nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are     hospitalized.   "
93845|NCT02057744|"     To quantify potential short- and long-term benefits of robotically-guided minimally invasive     spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching     group of control patients operated in a minimally invasive approach whether freehand or with     image guidance or navigation techniques.   "
93846|NCT02057731|"     The purpose of the study is to determine whether carrier status for any type of glycogen     storage disease (GSD) predisposes the carrier to GSD markers, like high cholesterol, by     testing blood, urine, and saliva samples.   "
93847|NCT02057718|"     This is an open label study in children with Progressive Familial Intrahepatic Cholestasis     (PFIC) designed to evaluate the safety and efficacy of LUM001. Efficacy will be assessed by     evaluating the effect of LUM001 on the biochemical markers and pruritus associated with PFIC.   "
93848|NCT02057705|"     This is a prospective, non-interventional, longitudinal study of the natural history and     function of approximately 60 patients with MTM from the United States, Canada and Europe. The     duration of the study, including the enrollment period, will be 36 months. Data from the     study will be used to characterize the disease course of MTM and determine which outcome     measures will be the best to assess the efficacy of potential therapies.   "
93850|NCT02057679|"     Acute cholecystitis (AC) is a very common complication of cholelithiasis, encountered in 20%     of symptomatic patients.      Nowadays laparoscopic cholecystectomy (LC) is the standard treatment in mild and moderates     forms of diseases and antibiotic therapy in the postoperatory of these patients remains under     discussion. However in the beginning, AC presents itself as an steril process, the     obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis,     as well as bacterial proliferation within the gallbladder lumen. Bactibilia was a significant     factor associated with total, as well as infectious, operative complications. Regarding this,     for some authors, monotherapy with amoxicillin clavulanic (AMC) would be the best treatment     after LC in patients with mild and moderate cholecystitis without intraoperative     complications such as bile peritonitis, cholangitis, gallbladder perforation or abscess. In     the other hand, others do not prescribe antimicrobial treatment after surgery in these     selected patients.      There is controversy regarding the postoperative treatment with antibiotics in patients with     mild and moderate cholecystitis and all the evidence about this topic.      Therefore, investigators decided to conduct a prospective randomized study in patients     undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer. The     patients will be randomized to receive AMC or placebo after surgery. With this study     investigators intend to prove that are no clinical differences in postoperative outcomes     between patients treated with AMC and placebo.      The primary aim of the trial is to assess that there are no benefits in the use of     postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a     laparoscopic cholecystectomy was performed.   "
93851|NCT02057666|"     To confirm the effect of tasquinimod in delaying disease progression or death as compared     with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer     (mCRPC).   "
93852|NCT02057653|"     As part of a quality assurance program, the Department of Anesthesiology implemented a     Goal-Directed Fluid Management training course for all physicians and nurses to provide     goal-directed fluid management. We intend to assess whether there has been any improvement in     patient outcomes by analyzing de-identified clinical information that are readily available     via the medical center electronic medical record system. The time-frame we are interested in     is one year before and one year after the Goal-Directed Fluid Management training curriculum     (June 15, 2011 to September 15, 2013).   "
93853|NCT02057640|"     This study will look at the safety and tolerability of the new drug MLN9708 in combination     with the existing drugs panobinostat and dexamethasone among patients with relapsed or     refractory multiple myeloma. This study will also look at the response and clinical benefit     of the treatment and the progression-free survival and overall survival of study     participants.   "
93865|NCT02057471|"     20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are     planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous     ferric carboxymaltose (FERINJECT).      It is hypothesized that intravenous iron supplementation is efficacious at raising     haemoglobin levels and reduced blood transfusion requirements.   "
93866|NCT02057458|"     Cystic fibrosis (CF) has many health consequences. A reduction in the ability to perform     exercise in patients with CF is related to greater death rates, steeper decline in lung     function, and more frequent lung infections. However, the physiological mechanisms for this     reduced exercise capacity are unknown. The investigators laboratory recently published the     first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is     reasonable to suspect that the blood vessels are involved with exercise intolerance in CF.     This study will look at how 1) blood flow and 2) artery function contribute to exercise     capacity in CF.   "
93854|NCT02057627|"     Maternal depression and mother-infant relationship dysfunction have reciprocal effects on     each other. An integrated approach addressing both problems simultaneously may improve     outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum     depression and facilitate optimal mother-infant relationships. The purpose of this pilot     study is to determine the feasibility, acceptability, and preliminary efficacy of PDP.     Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high     depression symptom levels) and their 6-week-old infants will be randomized to receive either     the PDP intervention or a control condition. The PDP intervention consists of 8 home-based,     nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based,     mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented     component focused on promoting positive mother-infant interactions. Control mothers will     receive usual care plus depression monitoring by phone. Data will be collected at baseline,     post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis     and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant     interaction.   "
93855|NCT02057601|"     The purpose of this study is to determine that periarticular levobupivacaine infiltration     after surgical fixation of fractured neck of femur will improve the early postoperative pain     sensation.   "
93856|NCT02057588|"     The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from     implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various     electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be     collected to characterize electrical conduction patterns during standard electrophysiology     exam.   "
93857|NCT02057575|"     To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its     individual components in patients with open angle glaucoma or ocular hypertension.   "
93858|NCT02057562|"     Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore     adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced     age and male gender are associated with the detection of adenomas. The same epidemiological     pattern can be found with regard to colon diverticula. Furthermore, western world countries     report higher incidences of both colorectal carcinoma as well as diverticular disease. It is     not known whether a correlation exists between both entities. Some recent data have     postulated higher adenoma detection rates in patients with concomitant diverticular disease     (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J     Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would     possibly affect recommendations regarding colonoscopy surveillance intervals for patients     with and without diverticular disease. The investigators therefore plan to conduct the     following trial.   "
93859|NCT02057549|"     Randomized controlled trial comparing haloperidol combined with conventional therapy and     conventional therapy alone in patients with symptomatic gastroparesis.   "
93893|NCT02057107|"     Compare the overall survival of patients with the addition of docetaxel to the overall     survival of patients treated with SBRT and cetuximab alone. In addition, we will determine     the difference in progression free survival (PFS), the rate of local recurrence (LR) and of     distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving     SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS,     LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment     and then randomized to either the control arm (cetuximab and SBRT only) or the experimental     arm (cetuximab, SBRT, and docetaxel).   "
93860|NCT02057536|"     The objective of this study is to determine if patients taking aromatase inhibitors (AI), who     are experiencing joint discomfort and stiffness, would have reduction in this discomfort and     stiffness by participating in a directed exercise program. The overarching objective is to     improve patient compliance with the medication and ultimately clinical outcome.      In this pilot study, we will utilize a scientific approach for proof of concept employing     both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and     subjective (patient perception) methods to support an evidence based clinical plan. Patients     will be divided into two cohorts. Group A will receive AI therapy with a directed exercise     program. Group B will receive AI therapy without a directed exercise program. Data will be     collected when both cohorts of patients enroll in the study, at the end of PT for Group A     and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT     evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that     includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression     scale, and pain level scale.   "
93861|NCT02057523|"     The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria     associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.   "
93862|NCT02057510|"     The purpose of this study is to measure the two-year rate of tooth loss in patients who have     received external beam radiation therapy with curative intent for head and neck cancer. The     study will also evaluate the sequelae of radiation therapy and oral complications that may     occur as a result to receiving radiation therapy.   "
93863|NCT02057497|"     G (guanine nucleotide binding) proteins associating with G protein-coupled receptors (GPCR)     are key players in the pathogenesis of obesity and diabetes and are targets of     pharmacotherapeutic inter-ventions. In addition, G proteins binding to GPCRs either directly     or permissively determine the efficacy of lifestyle interventions and drugs aiming at weight     management and diabetes treatment. Polymor-phisms of the fat mass and obesity-related protein     (FTO) gene have been also well characterised and linked to energy intake, body fat mass as     well as CVD risk and the susceptibility to weight-reducing interventions. Stratifying     patients according to G protein and FTO-related genotyping may enable a more accurate     prediction of individual disease courses and responses to therapeutic interventions in terms     of safety and tolerability as well as efficacy. Although the objectives primarily refer to     the analysis of G pro-tein and FTO-related genotypes, also other genes of potential relevance     for the evolution of obesity and/ or diabetes and the response to lifestyle and     pharmacological interventions may be analysed.   "
93864|NCT02057484|"     The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once     daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft     recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney     and liver allograft recipients.   "
93867|NCT02057445|"     The administration of allogeneic third party derived LMP specific-CTLs (special peripheral     blood cells from another person) that are made specific to fight EBV infection) in Children,     Adolescents and Young Adults (CAYA) with EBV-associated refractory or relapsed lymphoma will     be feasible ( able to be done), safe and well tolerated (no unexpected serious events will     occur). In addition, potential donors who are EBV positive will be enrolled to donate     peripheral blood to help build a bank of these specific EBV fighting cell lines.   "
93868|NCT02057432|"     This research study is a pilot study designed to evaluate magnetic resonance imaging-guided     therapy (MRT) as a possible treatment for breast cancer. In this pilot study, the     investigators are studying if it is possible to use intra-operative MRI to guide surgery. The     therapy takes place in the Advanced Multimodality Image Guided Operating (AMIGO) suite at     Brigham and Women's Hospital.      The purpose of this study is to investigate if it is possible to perform the breast     conserving surgery with the help of intra-operative magnetic resonance imaging in the     advanced multimodality image guided operating suite. It is hoped that intra operative MRI may     improve the surgeon's ability to know the exact margins of tumor. Currently, approximately     40% of women need to come back to the operating room and have the margins of the cancer     re-excised.   "
93869|NCT02057419|"     The purpose of this study is to answer the following questions: (a) how do sexual and     reproductive health (SRH) delivery method characteristics play a role in user preference for     specific SRH methods; (b) can we understand the interplay between salient SRH product     characteristics and effective use; (c) does effective use differ by indication (e.g., whether     the product is for contraception or lubrication); and (d) can this knowledge help product     developers better understand how to design new SRH products and develop behavioral (or     point-of-care) interventions to optimize use?   "
93870|NCT02057406|"     Omega 3 supplements will improve depressive symptoms to a greater extent than placebo in     heart failure patients with moderate to severe major depressive disorder.   "
93911|NCT02056873|"     The purpose of this study is to evaluate the effectiveness and safety of deep brain     stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS).      This investigation will (1) test the hypothesis that centromedian (CM) continuous brain     stimulation will be an effective, safe method for the treatment of tics in medication     refractory TS, (2) will define the intra-operative and post-operative physiological changes,     and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an     alternative to chronic DBS in TS.   "
93871|NCT02057393|"     The initial treatment for most people with melanoma involves wide excision of the skin and     sentinel node biopsy. As with other cancers, the status of the sentinel node provides     important prognostic information to the patient and physician. Sentinel node biopsy was first     developed using only a blue dye. Technetium99, a radioactive protein, was added later and     provides the ability to image the patient and identify relevant lymph node basins. For the     last 15 years or so, the standard method of SLN localization includes both tech99 and blue     dye. While the rates of localization overall are excellent, these methods each have     drawbacks. We are investigating a new method of finding sentinel nodes that uses a green dye     that has an infrared signal. Our hypothesis is that indocyanine green (ICG) and real time     lymphangiography is equivalent to technetium99 and methylene blue in identifying sentinel     nodes (SLN) in patients with melanoma.   "
93872|NCT02057380|"     The purpose of this study is to provide access to continued treatment for subjects who     participated in other Astellas sponsored trials and for whom the investigator feels the     subject may benefit from continued treatment.   "
93873|NCT02057367|"     Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid     consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared     to those who receive 0.9% normal saline solution (placebo).   "
93874|NCT02057354|"     The investigators are examining the effects of exercise and cardiovascular fitness on     cognitive processes, brain function, and the amount of several proteins in the blood. These     proteins include a hormone called cortisol, also known as the stress hormone, and a growth     factor called brain-derived neurotrophic factor (BDNF). The stress hormone cortisol is     produced by the adrenal glands. Stress, exercise, obesity, and other factors may influence     cortisol levels. BDNF is a protein that promotes the health of nerve cells in the brain and     in the body. It plays a role in the growth, maturation, and maintenance of these cells. The     amount of this protein in blood samples is therefore an indicator of healthy nerve cell     function. Here, the investigators are investigating if exercise improves brain function by     changing BDNF levels. Participation in this research study will take approximately 4 months.     During this time, participants will make four initial study visits. The first visit is for     informed consent and screening, the second and third visits are for baseline fitness testing,     and the fourth visit is for a blood draw, cognitive testing, and a functional Magnetic     Resonance Imaging (fMRI) exam. Functional MRI is a brain imaging technique that uses a     magnetic field to take pictures of the brain while a person performs a given task. It will     take up to approximately three weeks to complete these initial four study visits. Following     the four initial study visits, the exercise-training program will begin. Participants will be     randomized to one of two training programs: an aerobic exercise program and a non-aerobic     exercise program consisting of strengthening, balance and stretching exercises. The exercise     training program will last 12 weeks. There will be three one-hour exercise sessions per week.     After completion of the exercise-training program, participants will attend three follow-up     study visits. The first two follow-up visits are for fitness testing. The third and final     follow-up visit is for a blood draw, cognitive testing, and an MRI exam.   "
93875|NCT02057341|"     This is a Phase 2 pilot study, involving a 48-week treatment period, designed to test the     effectiveness of investigational study drug ARRY-371797 in treating patients with symptomatic     genetic dilated cardiomyopathy due to a lamin A/C gene mutation, and to further evaluate the     drug's safety. Approximately 12 patients from the US will be enrolled in this study.   "
93876|NCT02057328|"     Τhe effectiveness of newer angiotensin-II receptor blockers and cardioselective     beta-adrenergic blockers in treatment of arterial hypertension and in improvement of arterial     stiffness has been established in previous studies among the hypertensive population. The     present study is a comparison of the performance of two drugs, telmisartan and nebivolol, in     24h ambulatory blood pressure values and in the degree of arterial stiffness of patients with     stage I arterial hypertension.      Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement     devices and the method of pulse-wave velocity analysis. The effects of telmisartan and     nebivolol are going to be compared for a total time period of 12 months.      The aim of this project is to determine whether the expected decrease in arterial stiffness     of subjects with stage I arterial hypertension can be attributed to the blood pressure fall     solely, or to other factors as well. These factors are possibly dependent on the action of     these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral     vasodilatory actions.      The present study is going to be the first comparative test of the anti-hypertensive effects     of the two pharmaceutical substances in 12 months' time, and of the elimination of total     cardiovascular risk in terms of primary prevention of cardiovascular attacks.   "
93877|NCT02057315|"     This is a Phase 1/ Phase 2, 12-week, multi-center, randomized, double-blind, cross-over,     placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo     in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe     migraine headaches (2-8 per month).      This study is designed to describe the efficacy and safety of ELS-M11 as compared to placebo.   "
93878|NCT02057302|"     Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS),     which plays a dominant role in leading to CHD.      Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus).     It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino     acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in     a guideline for China adult dyslipidemia prevention.      This study aims to evaluate the benefit and side effect of Xuezhikang, a potential     alternative drug of statins, for patients with dyslipidemia, and thus provide further     evidence for clinical application.   "
93879|NCT02057289|"     The purpose of this research study is to examine the pharmacokinetics (the process by which a     drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when it     is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These     children are at high risk for developing invasive fungal disease due to their compromised     immunity and associated variable degree and duration of neutropenia. Currently, children who     receive micafungin are given daily or alternate day dosing. The investigators will give a ONE     TIME dose of micafungin and draw PK levels up to 96 hours post-infusion. The investigators     goal is to obtain comparable micafungin drug concentrations at the end of 96 hours (4 days)     as compared to lower dose at every 24 hour dosing. The investigators dosing proposal is     likely to be effective prophylaxis for immunocompromised patients and would broaden its     applicability to larger populations.   "
93880|NCT02057276|"     The purpose of this study is to determine whether Repetitive Transcranial Magnetic     Stimulation (rTMS) can augment occupational therapy in improving motor function in children     (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from     either stroke or cerebral palsy.   "
93912|NCT02056860|"     The purpose of this study is to test a lung air vibrator device for vibrating air inside the     lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting     lower airway infections using exhaled breath sample.   "
93881|NCT02057263|"     Vaccines are one of our most effective public health tools but many who need them don't     respond well and are not protected. Adjuvants boost immune responses and are commonly     included in vaccine preparations. Bisphosphonates are the most commonly prescribed treatment     for osteoporosis and may represent a new class of adjuvant. Bisphosphonates are well     tolerated with chronic administration and have very few adverse effects. Research suggests     that these medications can stimulate the immune system.      Bisphosphonates are of special interest in populations with impaired immunity and an     inability to amount protective antibody responses following immunizations. We propose a pilot     study to evaluate the clinical relevance of this finding in humans. We will study the effect     of bisphosphonates on quantitative humoral immune response to hepatitis B vaccine in healthy     older volunteers who have not previously received this vaccine.   "
93882|NCT02057250|"     Primary Objective:      To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid     arthritis (RA) participants.      Secondary Objective:      To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus     prefilled syringes (PFS).   "
93883|NCT02057237|"     1. The primary objective of this study is to assess the feasibility of treating patients          with metastatic castration resistant prostate cancer with mitotane. Secondary objectives          are to assess safety and tolerability as well as response rate of therapy        2. To assess the toxicity of Mitotane in men with HRPC        3. To assess the relationship between baseline serum adrenal androgens and their response          to Mitotane   "
93884|NCT02057224|"     Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in     addition to reducing blood pressure. The mechanisms are however unclear. The investigators     hypothesize that renal denervation alters adipose tissue function by reduced sympathetic     outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15     clinical patients undergoing renal denervation are recruited to the study investigating     anthropometry, peripheral blood samples, body composition, heart rate variability and     subcutaneous fat biopsies at baseline and 6 months after renal denervation.   "
93885|NCT02057211|"     This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to     preserve insulin production and beta-cell mass in recently diagnosed patients with type 1     diabetes mellitus. The hypothesis to be tested is that an increased number of circulating     mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune     process in islets causing progressive beta-cell death.   "
93886|NCT02057198|"     The overall aim is to characterize and to compare the extent and quantity of C. difficile     stool shedding, perianal colonization and environmental contamination in patients who     received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective,     randomized, microbiologic and molecular, study of environmental contamination from patients     with proven C. difficile associated diarrhea (CDAD).   "
93887|NCT02057185|"     Diseases do not only have a physical role in people's live, but they usually involve changes     in life as whole. They may modify the structure of the conjunction with life setting, thus,     deeply impacting relationships with others. While clinical results of new therapies for     hematological diseases are well documented in scientific literature in terms of prolonged     life expectancy or remission from disease, less is known about problems and barriers     preventing the return of patients with a chronic blood ailment to everyday life.      Indeed, there are no published data on this topic within the Italian context. The present     explorative study aims at identifying the main problems with which patients affected by a     Chronic Hematological Disease (CHD) deal when returning to everyday working life, factors     associated with work reintegration and, finally, to understand the need for facilitators     enhancing reintegration outcomes.      Results from this study will be also helpful to raise consciousness about the problem of     reintegration into the labour market of workers with CHD and to call for awareness campaigns     for the general public and health professionals.   "
93890|NCT02057146|"     Single operater pancreatico-cholangioscopy is performed through the working channel of     conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems     is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps.      Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation     of suspected premalignant lesions in the biliary duct and in the pancreas.   "
93891|NCT02057133|"     The main purpose of this study is to evaluate the safety of a study drug known as LY2835219     in combination with different therapies (letrozole, anastrozole, tamoxifen, exemestane,     exemestane plus everolimus, trastuzumab, or LY3023414 plus fulvestrant) for breast cancer     that has spread to other parts of the body.   "
93892|NCT02057120|"     The objective of the project is to investigate the influence of application of Kinesio Taping     in young athletes in football, muscle strength and muscle activation in the performance of     the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted a randomized,     placebo-controlled and double-blind. 24 individuals will be athletes who fit the criteria for     inclusion will be randomized into 2 groups (Placebo, Kinesio Taping Taping) and will be     submitted to the tests of Single Leg Hop Test, Triple Hop Test, the isokinetic evaluation and     electromyographic of Rectus Femoris dominant lower limb. Then the intervention shall be     carried out with application of Kinesio Taping for activation of rectus femoris muscle group     and placebo intervention Kinesio Taping with application of Kinesio Taping of transverse way     the rectus femoris without tension in the Placebo group Taping. The volunteers will be     re-evaluated 30 minutes after application of the technique and 12:0 am after with the same     tests for that later can be compared the results obtained in each group. Analysis: will be     achieved statistical tests and adopted a significance level of 5 percent   "
94323|NCT02051478|"     The purpose of this randomized clinical trial was to examine the widespread effects of     thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain     sensitivity and neck pain intensity in patients with chronic mechanical neck pain.   "
93894|NCT02057094|"     The purpose of this study is to evaluate the physiological consequences of extreme military     training and determine whether protein supplementation enhances recovery by promoting gains     in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist,     Escape (SERE) school at Camp Lejeune, North Carolina.      SERE school may be an ideal setting to assess nutritional interventions that promote recovery     from severe military operational stress, and identify innate or experiential variables that     may lead to increased levels of resilience in Warfighters. Our laboratory has recently     demonstrated the detrimental effects and stressful nature of SERE. Heart rates and     stress-related hormones increased dramatically, with concomitant reductions in circulating     anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which     probably included lean body mass. The effects of severe operational stress induced by SERE,     particularly the loss of lean mass, may degrade physical performance, increase injury risk,     and compromise military readiness. Under controlled laboratory conditions, consuming high     protein diets or supplemental high-quality protein promotes muscle protein retention,     enhances muscle protein synthesis, and protects lean body mass in response to stress. Whether     consuming supplemental protein promotes lean mass recovery and physiological resilience     following a 'real-world' military stress has not been determined. Further, the level of     supplemental protein necessary to optimize recovery from extreme military operational stress     has not been elucidated.      Up to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial.     Using complex body composition measurements, kinetic modeling of human metabolism, blood     sampling and cognitive and nutrition questionnaires, the consequences of SERE and the     efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will     be assessed.      We hypothesize that consuming a specially formulated, high-quality supplemental protein     ration item will speed recovery of lean body mass, physiological, and psychological     resilience following extreme military operational stress.   "
93895|NCT02057081|"     This project addresses the rehabilitation and mental health needs of married combat Veterans     post-deployed from Iraq or Afghanistan with a mild traumatic brain injury (mTBI) by providing     psychoeducation, communication and problem solving skills in a multifamily group (MFG)     setting. In this group, Veterans and spouses/cohabiting partners learn customized therapeutic     strategies to help compensate for mTBI deficits and promote Veteran community integration,     interpersonal and emotion regulation skills, and marital satisfaction. The effectiveness of     the skills-based MFG will be compared to that of a health education group which offers a     supportive environment and basic education without skills training through a randomized     clinical trial. As there is currently no family-based intervention for Operation Enduring     Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with mTBI offered within the VA spectrum     of services, this intervention fills a crucial gap in healthcare for our newest Veterans.   "
93896|NCT02057068|"     This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a     topic that has important implications for the safety, health, functioning and quality of life     of older Veterans living at home and being cared for by a family caregiver (CG). The purpose     of the first phase of this study is determine the relationship between CG and care recipient     (CR) sleep and describe the impact of dyadic sleep to daytime functioning and well-being for     Veterans and their caregivers. The information from phase 1 will inform the next study phase     in which the investigators develop and field test non-pharmacological, technology based,     sleep hygiene, exercise and meditation interventions to improve sleep in Veteran caregiving     dyads.   "
93897|NCT02057055|"     Recent research in the investigator's lab has shown that bacteria are present not only on the     outer surface of our skin, but also in the deeper components as well. In this study, the     investigator will study the bacteria present in different components of the skin including     the epidermis, dermis, subcutaneous fat, and hair follicle, and determine if and how these     bacteria change after repeated use of different commercially available hand soaps. It is     expected that the bacteria populations in the different skin components will change with the     use of different soaps.   "
93898|NCT02057042|"     The investigators will conduct a randomized clinical trial of Peer-Supported cCBT versus     enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at     three VA sites and their associated Community-Based Outpatient Clinics (CBOCs).   "
93899|NCT02057029|"     Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients'     anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.   "
93959|NCT02056249|"     The aim of this study is to use Positron Emission Tomography (PET) imaging to measure changes     in norepinephrine transporter (NET) concentrations in the brain and periphery of healthy     individuals during hypoglycemia.      We hypothesize that during hypoglycemia, NE levels will increase within the brain, especially     the hypothalamus, and this likely contributes to activation of glucose counterregulatory     responses. We further hypothesize that during hypoglycemia, NET concentrations in key     glucoregulatory regions will change in order to sustain or prolong sympathetic nervous system     activation of counterregulatory responses.   "
93900|NCT02057016|"     The primary objective of this study is to evaluate sustained clinical remission (for the     definition see below) in patients with inflammatory bowel disease receiving long-term (> 2     years) scheduled treatment with infliximab.      Secondary objectives include:        -  to identify predictors of sustained clinical remission during long-term infliximab          scheduled treatment        -  to identify predictors of loose of response during infliximab scheduled maintenance          treatment        -  to identify predictors for maintaining clinical remission in patients who discontinue          infliximab because of long-lasting steroid-free clinical remission        -  to evaluate percentage of surgery during and after treatment (total follow-up)        -  to evaluate safety of long-term infliximab scheduled treatment      List the clinical hypotheses      Infliximab is indicated and recommended in moderate to severe inflammatory bowel disease     patients who not tolerate or are not responsive to conventional therapies. Most of randomized     clinical trials about the use of infliximab in inflammatory bowel diseases are limited to 52     weeks and very few data come from some observational studies about results of prolonged (over     one year) treatment with infliximab. No validated predictors of sustained clinical remission     or loss of response are available so far. Moreover, few data are available about the     hypothetical reduction of IBD related surgery in the biological era.      In this proposal we suggest the following hypotheses:        -  infliximab scheduled treatment may be efficacious in maintain long-term clinical          remission;        -  among clinical, laboratory and endoscopic data some predictors of sustained clinical          remission during infliximab long-term scheduled treatment may be found;        -  among clinical, laboratory and endoscopic data some predictors of loss of response          during infliximab long-term scheduled treatment may be found;        -  among clinical, laboratory and endoscopic data some predictors of sustained clinical          remission after infliximab discontinuation because of long-lasting (> 6 months)          steroid-free clinical remission may be found;        -  maintenance of remission with infliximab may reduce rates of surgery over time;        -  long-term scheduled treatment with infliximab may be safe and well tolerated. Results          from this study may really help clinicians to make practical decisions in these          particular clinical settings.   "
93901|NCT02057003|"     The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens     in the clinical practice in HIV/HCV-coinfected patients.      Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is     different to what is observed in clinical trials in HIV/HCV-coinfected patients.   "
93902|NCT02056990|"     Athletes have to participate in screenings in order to reduce injuries. Up-to-now most     screenings are purely clinically based. Literature, however, indicates the importance of     knowledge on deviant movement patterns as possible risk factors for injuries. From this     perspective, the current project aims to measure movement patterns, gait and running in young     athletes to optimise training and prevent injuries.      2D- and 3d registration methods, force plate data and pressure plate data will be used to     document the performance of the athletes.   "
93913|NCT02056847|"     Primary Objective      : To evaluate that there is no different effect on HbA1c between routine lipid lowering     therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic     patients with impaired fasting glucose (IFG).      H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4      µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the     control drug (Pitavastatin 2 MG)   "
93914|NCT02056834|"     The primary objective of this study is to observe the safety, the radiological and clinical     outcomes of chronOS Inject after having been used as bone void filler in internal fixation of     proximal tibial fractures.   "
93903|NCT02056977|"     The purpose of this study is to:        -  Compare PEEP level selected by individualized PEEP titration by electrical impedance          tomography and PEEP level routinely used in post-operative cardiac patients with ARDS;        -  Compare the stability of the selected PEEP in both groups: individualized PEEP titration          by electrical impedance tomography and the Control group (default strategy currently          used in the institution)        -  Evaluate the agreement between the results of a rapid titration (total procedure          duration = 5 min) versus an already validated slow titration (total procedure duration =          40 min) of the same patient, sequentially. Specifically, degree of collapse and degree          of distention in each PEEP level, estimated by EIT;        -  Compare hemodynamic and oxygenation effects during the two maneuvers titration;        -  Evaluate the stability of the selected PEEP according to the rapid titration (minimum          PEEP capable of collapsing equal or less 1%) in the maintenance of three variables over          a four hour period: arterial oxygenation, respiratory system compliance, and degree of          collapse by EIT;        -  Compare these results (evolution of the three variables, within 4 hours) compared to          control (default strategy currently used in the institution) group.        -  Evaluate collapse amount determined by electrical impedance tomography (collapse < 1%)          and compares with collapse amount determined by pulmonary ultrasound during PEEP          titration and pulmonary recruitment maneuver .   "
93904|NCT02056964|"     The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical     decision aid for the care of patients with chest pain, in a real-world clinical setting.     This will be accomplished through the building of a transformative collaboration between     research, education, and health systems operations to more effectively and efficiently     provide patient care.   "
93905|NCT02056951|"     The primary aim of the study is to analyse the long-term effectiveness of an     interprofessional and interdisciplinary rehabilitation program named PASTOR, with a     biopsychosocial approach for participants with chronic non-specific low back pain (CLBP)     compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in     Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program     PASTOR would result in a significantly higher increase in functional ability 12 months after     completion of the program in comparison to the standard inpatient MOR. The investigators     further hypothesize that PASTOR would lead to significantly larger improvements regarding     pain-related cognitions, pain coping strategies, physical activity, health-related quality of     life, and back pain episodes compared to the standard inpatient MOR.   "
93906|NCT02056938|"     The primary objective of the following randomized open label trial is to demonstrate how low     immunological risk patients (no anti HLA immunization and first kidney transplantation) but     diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from     induction with ATG for preventing delayed graft function compared to Basiliximab.   "
93907|NCT02056925|"     · 2D Speckle Tracking echocardiography gained importance for the evaluation of ventricle     contractility. Many indications have been developed in child population. However, the     comparability of measurements between different software systems is not well defined. We     choose to compare two software systems very often used in paediatric subjects : Echopac by     General Electric and QLAB 9.0 by Philips. We offer a randomly second echocardiography to     children which have normal heart. We compare Strain and Strain rate results between the two     tests with a study of variability : ultrasound variability, operator variability, reader     variability.   "
93960|NCT02056236|"     The purpose of this study is to estimate the effect of medical treatment of     electro-encephalographic status epilepticus on neurological outcome of patients with     postanoxic encephalopathy after cardiac arrest.   "
95316|NCT02038517|"     This observational study is aimed at assessing insulin secretion and sensitivity by the use     of a mathematical modeling from oral glucose tolerance test in subjects with liver cirrhosis     undergoing orthotopic liver transplantation (OLT), before and at various time points after     OLT.   "
93908|NCT02056912|"     Human lipodystrophies (lipoD) represent a heterogeneous group of diseases characterized by     generalized or partial fat loss, with fat hypertrophy in other depots when partial.3, 4     Insulin resistance, dyslipidemia and diabetes are generally associated, leading to early     complications. Acquired lipoD can be generalized, resembling congenital forms, or partial, as     the Barraquer-Simons syndrome, with loss of fat in the upper part of the body contrasting     with accumulation in the lower part. The most common forms of lipoD are iatrogenic. In human     immunodeficiency virus-infected patients, some first-generation antiretroviral drugs were     strongly related with peripheral lipoatrophy and metabolic alterations. Genetic forms are     very uncommon: recessive generalized congenital lipoD result in most cases from mutations in     the genes encoding seipin or the 1-acyl-glycerol-3-phosphate-acyltransferase 2 (AGPAT2).     Dominant partial familial lipoD result from mutations in genes encoding the nuclear protein     lamin A/C or the adipose transcription factor PPARgamma. Importantly, LMNA mutations are also     responsible for metabolic laminopathies, resembling the metabolic syndrome and progeria, a     syndrome of premature aging. Molecular genetic bases of many rare forms of genetic lipoD     remain to be elucidated.   "
93909|NCT02056899|"     This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin     therapy on the rate of premature birth in women who have had preterm labor.   "
93910|NCT02056886|"     Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this     way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis     of a metastatic lymph-node invasion, mainly in the axillary field. Axillary surgery is     therefore mandatory at the diagnosis of breast carcinoma. For many years, in order to avoid     unnecessary complications due to extensive axillary surgery (for instance, arm enlargement by     lymphedema), a limited surgery is frequently performed on the first supposed invaded     lymph-nodes (LN) called sentinel LN technique; if the sentinel LN are not invaded,     extensive axillary surgery can be omitted. To decide it during the surgery, removed sentinel     LN are cut in 3 to 4 slices which are examined immediately as smears (cytology) or frozen     slices (pathology). However, due to hazard in cutting the LN, micro-metastases can be     misdiagnosed. That is why a recent molecular biology method has been developed in which the     total LN are crushed and blended, then analyzed by OSNA technique (One Step Nuclear Acid     analysis) so as to amplify and detect the mRNA coding for cytokeratin-19 protein witnessing     the LN metastatic invasion. A standardized automated technique is available with a mean time     of 30 to 50 minutes according to the number of analyzed LN.      In 12 international studies (2830 cases) the consistency between OSNA technique and final     pathology is of 91 to 98% and the sensitivity seems higher. Less than 5% of all breast     carcinomas cells don't express CK-19 protein.      The use of OSNA technique requires a dedicated machine and a skilled pathologist, increasing     slightly the operation time; however it allows to avoid the immediate and long-term     complications due to the radical LN axillary surgery in case of negativity of the sentinel LN     procedure. To date, the three techniques including extemporaneous examinations (OSNA or     classical methods) or not (classical pathological analysis) have their own advantages and     drawbacks.      SAGE study main objective is to compare these three techniques in terms of direct costs and     Quality of Life impacts. The superiority of any of these three techniques is not the purpose     of SAGE study, but the economic burden of OSNA technique in comparison with the 2 others in     the standard setting in France.      Quality of Life and Pain evaluations will be performed immediately after surgery and during     the 6 months after.   "
93967|NCT02056145|"     Evaluation of the combination of lateral femoral cutaneous nerve single shot and femoral     nerve single shot block as effective and safe alternative postoperative analgesic technique     after hip replacement surgery.   "
93915|NCT02056821|"     This study investigates if there are hemodynamic alterations in acute stroke that predispose     patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will     target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of     symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring     contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.   "
93916|NCT02056808|"     The purpose of this study is to determine whether increasing doses of SMT C1100 are safe,     well tolerated and achieve appropriate blood levels in patients with Duchenne Muscular     Dystrophy (DMD).   "
93917|NCT02056795|"     Introduction: Ankle sprains, the most common sports-related musculoskeletal injury, account     for approximately 25% of sports injuries. An estimated 40% of these individuals will progress     to develop chronic functional ankle instability (CFAI), which can significantly affect     athletic performance and activities of daily life. Stresses from the injury can damage the     ligaments, muscles, nerves and mechanoreceptors. It is widely accepted that ankle     proprioception is critical for balance and that individuals with CFAI demonstrate decreased     proprioception and altered muscular function, which impairs postural stability. The goal of     this study is to determine if a single application of electroacupuncture can have an     immediate positive outcome related to balance in individuals with CFAI.      Methods: This single blinded randomized trial will include 12 subjects receiving a single     application of electroacupuncture and 12 subjects in the placebo group receiving sham     electroacupuncture. Subjects aged 18-50 with a history of unilateral inversion ankle     sprain(s) and chronic symptoms of instability will be selected. Balance will be assessed pre-     and post-treatment using force plate data during a single-leg stance and via the Star     Excursion Balance Test (SEBT). GB-34 and GB-40 will be used for the experimental group and     non-traditional points on the medial aspect of the leg will be used for the sham     electroacupuncture group. Both will be connected to the electrical stimulation unit for 10     minutes. Results from this study may inform future research investigating the ability of EA     at decreasing the risk of ankle sprains, improving perceived stability, and reducing the risk     of subsequent degenerative changes.   "
93918|NCT02056782|"     A Pilot Study of ODSH in Acute Myeloid Leukemia   "
93919|NCT02056769|"     Patients with brain hemorrhage resulting from a ruptured aneurysm (SAH) are at risk of     developing a condition called vasospasm, one or two weeks after their hemorrhage. This is a     major cause of stroke and death following SAH. A special type of CT scan, called CT     perfusion, analyzes regional blood flow in the brain. We hypothesize that CT perfusion scans     performed on admission and day 6 post-hemorrhage will enable us to predict which patients     will go on to develop vasospasm.   "
93920|NCT02056756|"     Open-label phase Ib/II, multicenter, international non-comparative trial. This study is     designed to determine the safety and efficacy of the novel salvage regimen (CBd) followed by     a carfilzomib maintenance in patients with relapsed or refractory multiple myeloma.      Patients will be evaluated at scheduled visits in up to 4 study periods:      pretreatment, treatment, maintenance and long-term follow-up (LTFU).   "
93921|NCT02056743|"     The purpose of this study is to evaluate the possibility of drug interactions before and     after taking red ginseng or fermented-red ginseng by estimating metabolic rate of indicator     drugs for cytochrome P450 and P-glycoprotein.   "
95317|NCT02038504|"     The purpose of this study is to investigate whether enteral nutrition are effective in the     treatment of nonthyroidal illness syndrome among fistula patients.   "
93922|NCT02056730|"     The dialysis patient of chronic kidney disease and parathyroid hormone levels greater than or     equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to receive     medication and a control group that did not receive the medication. By group to receive in     those taking 25 mg per day to get the default dose and the dose is adjusted according to the     levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a     period of 12 weeks, the drug is between 25-75 mg dose , with a maximum dose of not more than     100 mg per day (weeks 3, 6 , 9).      After a follow-up treatment in weeks 12, 24 and 36 with an blood,ultrasound test parathyroid     glands , abdominal x-ray side . To evaluate the changes without the drug .Unless the track     during treatment the patients with low blood calcium levels over 8.4 mg per dL . No dose     adjustment . regpara while if blood calcium levels less than 7.5 mg per deciliter . Must be     stop taking medication for patients in the control group will receive standard treatment .     Which consisted of dose vitamin D sterol and parathyroid surgery . Unable to control the     level of parathyroid hormone with vitamin D sterol.      While participating in the research are not allowed to adjust the amount of vitamin D sterol     in the two groups . But the amount of dialysate calcium phosphate binders and can be adjusted     as appropriate to healthcare is fine .   "
93923|NCT02056717|"     The primary purpose of this study is to investigate the effects of dexamethasone on     inflammatory reactions after uterine artery embolization. The secondary purpose of this study     it to investigate the effects of dexamethasone on postembolization syndrome (severe pain,     nasea and vomiting).   "
93924|NCT02056704|"     The reason the investigators are doing this study is to compare the results of angiography     versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are     blocked.   "
93925|NCT02056691|"     This pilot study looks to explore the biological effects of exercise on cancer and muscle     cells using a two week exercise program (HIThigh intensity training) on 20 patients with     newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery.     Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the     feasibility of recruiting participants to and carrying out a two week preoperative exercise     program in patients with colorectal cancer.   "
93926|NCT02056678|"     The objective of this study is to determine if IV acetaminophen administered intraoperatively     can decrease the dose of narcotics required for adequate pain control and shorten recovery     time in the PACU specifically in obese patients at risk for obstructive sleep apnea.   "
93927|NCT02056665|"     RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF     MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)   "
93981|NCT02055963|"     The goal of this clinical research study is to learn if Minocin® (minocycline) can reduce     certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue,     and disturbed sleep). In this study, minocycline will be compared to a placebo.      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
93928|NCT02056652|"     Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The     incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at     less than 37 weeks gestation annually. The rate of PTB in the United States increased to     12.8% in 2006, and remains high compared to almost all other developed countries, despite the     introduction of many public health and medical interventions designed to delay PTB. Weekly     treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has     been shown to significantly reduce the risk of PTB and is currently recommended for women who     experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of     spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB     is likely to have a small effect on the overall rate of prematurity since only about 10% of     spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality     and morbidity in premature babies will only be achieved with increased precision in the     identification of women at risk of spontaneous PTB and through the development of an     effective prevention for this complication. Transvaginal ultrasound measurement of cervical     length is a reliable screening test for prediction of PTB. Although treatment with vaginal     progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women     still experience premature delivery and many women find daily administration of progesterone     to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may     be effective in preventing PTB. If effective this approach would be particularly appealing     because of the wide availability of pessaries, ease of use, and low cost. Unfortunately,     existing studies are inadequate to confirm effectiveness; a well designed, properly powered,     prospective randomized trial is warranted prior to widespread implementation in clinical     practice. We propose such a trial to study the effectiveness of the pessary in decreasing the     incidence of PTB in an inner city Philadelphia population.   "
93929|NCT02056639|"     Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall     perinatal mortality. Twins are at increased risk for PTB. The number of twins births has     risen substantially due to the increased use of assisted reproductive technology. The rate of     twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and     2004. The increased rate of PTB in twins is associated with increased morbidity and mortality     rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United     States are twins, as are one in six infants who die in the first month of life. Cervical     shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length     is a reliable screening test for prediction of PTB. There is currently no effective treatment     to decrease the incidence of PTB in women with twin gestations, but there is some evidence     that the use of a cervical pessary in women with a short cervix has promise. If effective     this approach would be particularly appealing because of the wide availability of pessaries,     ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm     effectiveness; a well designed, properly powered, prospective randomized trial is warranted     prior to widespread implementation in clinical practice. We propose such a trial to study the     effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia     population.   "
93930|NCT02056626|"     The proposed research is designed to determine if the application of classical conditioning     operations could influence the clinical effects of a regimen of antihypertensive drug     therapy. It will be determined if, capitalizing on conditioned pharmacotherapeutic effects,     patients can be effectively treated with smaller cumulative amounts of drug.   "
93974|NCT02056054|"     The purpose of this study is to provide insights into the cause, development and effects of     de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in     order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and     the need for re-transplantation.   "
93931|NCT02056613|"     Background:      - Pluripotent stem cells are cells that can be converted to any type of cell (muscle, nerve,     liver, etc.). Researchers are collecting blood samples to develop way to make a special cell     product called induced pluripotent stem cells (iPSCs). iPSCs may be used to repair or replace     organs and tissues, produce blood and immune cells for transfusion, or correct inherited     immune and blood diseases. iPSCs can be made from many kinds samples, such as skin, blood, or     hair. This is different from embryonic stem cells, which can only be derived from embryos.      Objectives:      - To develop new methods to make iPSCs; to identify better ways to collect, produce, and grow     them; and to make an iPSC bank.      Eligibility:      - Healthy adults and adults already in a treatment protocol who have a medical condition that     could be treated with iPSCs.      Design:        -  All participants will be screened with questionnaire, physical exam, and blood and HIV          tests.        -  All participants:        -  Will donate 4 tablespoons of blood. It will be taken by needle from a vein in their arm.        -  Participants already in another protocol:        -  Will have their blood collected, separated in a lab, and iPSCs grown in large numbers.          Some may have their sample given back to them as a treatment.        -  Samples will be kept in the study up to 5 years or until a participant withdraws from          the study or becomes ineligible to participate, or the study is closed. If participants          have not withdrawn their consent, they may be contacted in the future to donate again.   "
93932|NCT02056600|"     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of     gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component     administered in healthy male volunteers.   "
93933|NCT02056587|"     An estimated 10,000 metastatic renal cell carcinoma (RCC) patients receive first-line therapy     in the Russian Federation. Bevacizumab (Avastin) in combination with interferon-alpha (IFN)     is a recommended first-line treatment for metastatic RCC according to clinical     recommendations of Russian Ministry of Health from 15.07.2010. Two randomized phase III     trials (AVOREN, CALGB) showed that 50% of patients will progress on bevacizumab plus IFN     within 8.5 - 10.2 months and will need sequential therapy.      Everolimus (Afinitor) is a single agent which was evaluated and demonstrated efficacy in     randomized phase III study (RECORD-1) in metastatic RCC patients after failure of targeted     therapy. However, in this trial everolimus was compared with placebo for the treatment of     patients whose disease had progressed on treatment with sunitinib or sorafenib (n=227). Only     9% (n=24) of patients received bevacizumab. Thus, efficacy data of everolimus in patients     with disease progression on first-line bevacizumab is limited.      Evaluating the effectiveness of everolimus in metastatic RCC patients with failure on     bevacizumab with/without interferon alpha has a scientific and practical sense, and it is     important for Russian Federation.   "
93934|NCT02056574|"     This is a randomized, double-blind, placebo-controlled, single-dose study investigating the     safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing     endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients     with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed     with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of     the endovascular procedure on Day 1 of the study period. Subjects will undergo interim     procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.   "
94025|NCT02055378|"     To compare the effect of myopia control between patients treated with low-concentration     atropine eye drops combined with auricular acupoint stimulation and those treated with     atropine alone.   "
93935|NCT02056561|"     Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of     anesthesia and studies have shown that these anesthetics cause a variety of changes in     oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is     similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene     toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol     infusion anesthesia on the oxidant and antioxidant systems of patients undergoing     laparoscopic cholecystectomy.      Material and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II,     score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia     were included in the study. Patients were divided into 3 groups as total intravenous     anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n:     15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups     for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2%     sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50% air     and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for the     first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients     were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and after the     operation venous blood samples were taken to evaluate the levels of glutathion peroxidase,     total oxidants and antioxidants.   "
93936|NCT02056548|"     Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after     final chemotherapy and they revealed that many of the patients who stopped preemptive     antiviral drug within 6 months experienced viral reactivation. Based on the study results,     guidelines recommend that preemptive antiviral therapy should be maintained for at least 6     months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1~2 years or     longer after final chemotherapy without definite evidences, and this practice increases the     medical expenditure a lot. Therefore, the investigators are going to find out the proper and     safe duration of preemptive antiviral therapy which can be a good reference in the future     practice.   "
93954|NCT02056314|"     This study will compare a computerized tutorial to a brochure in terms of their education     impact of people who wish to end voluntary self-exclusion. Voluntary self-exclusion is a     program used by people who seek to bar themselves from further access to the casino or other     gambling venue. The Centre for Addiction and Mental Health (CAMH), in cooperation with     Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical     information to players who choose to reinstate and return to gambling. The goal of this study     is to determine if this new computerized tutorial decreases the harm of gambling experienced     by gamblers who are reinstated. For example, are they less likely to relapsing to problematic     levels of gambling.   "
93937|NCT02056535|"     The aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention     and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a     motivational intervention delivered by a Health Promotion Advocate, relative to standard care     with and without assessment, on a reduction in heavy drinking and alcohol-related problems in     the emergency department (ED) at the U.S.-Mexico border; and, 2) identify variables that are     related to effectiveness of the intervention and that predict successful treatment outcome.     Patients will be re-assessed by telephone at three and twelve months to evaluate outcomes.The     specific hypotheses to be examined in this proposal are: 1) the motivational interview will     lead to significantly greater reductions in the maximum number of drinks on an occasion and     in Rapid Alcohol Problem Screen (RAPS4) score at the 12-month follow-up compared to standard     care without assessment (those who screen positive but are not assessed) as well as compared     to standard care with assessment; 2) the motivational interview will lead to significantly     greater reductions in number of drinking days per week, average number of drinks per day,     maximum number of drinks on an occasion, RAPS4 score, and number of negative consequences of     drinking at 3-month and 12-month follow-up compared to standard care with assessment; 3) a     positive breath alcohol concentration (BAC) at the time of the ED visit and/or self-reported     drinking prior to the event resulting in the ED visit will be positively predictive of     effectiveness of the intervention; 4) attributing a causal association of drinking and the     reason for the ED visit will be positively associated with effectiveness of brief     intervention; 5) readiness to change (and stage of change) will be positively associated with     effectiveness of brief intervention; 6) risk taking/impulsivity and sensation seeking     dispositions will be negatively associated with effectiveness of brief intervention.   "
93938|NCT02056522|"     The use of MDS to access the presence of melanoma in the skin.   "
93939|NCT02056509|"     Airway management and maintaining adequate ventilation during cardiopulmonary resuscitation     (CPR) are important. The rule of 30:2 compression-to-ventilation ratios before endotracheal     intubation and keeping 1 breath every 6-8 seconds with advanced airway are generally accepted     according to 2010 Advanced Cardiac Life Support (ACLS) guideline. This recommendation     emphasizes on the timing and frequency of ventilation during CPR. However, poor clinical     evidence had been established concerning adequate volume, airway flow and pressure in each     cycle.      There are increasing evidence that hyperventilation during resuscitation reduces pulmonary     venous return and, therefore, compromises cardiac output and circulation. Another research     reported that using high flow oxygen mask alone during basic life support (BLS) results in     better survival rate and overall outcome compared with conventional positive pressure     ventilation.      Our study applies flowmeter to measure ventilation parameters as frequency, duration, exhaled     volume and airway pressure on intubated patients who received artificial ventilation during     CPR. The parameters will correlate with information from accelerometry and capnometry     simultaneously during resuscitation. . Investigators also focus on the influence of chest     compression, which increases intra-thoracic pressure considerably. This effect may act     against positive pressure ventilation and probably minimize the efficiency in each     ventilation or circulation..      Details about how to ventilate one patient during CPR include right timing, duration,     adequate volume and coordination are in debate. Unfortunately, current practice based on     clinical guidelines emphasizes little on this issue. Investigators are committed to refine     contemporary practices and hopefully improve qualities of resuscitation.      Investigators proposed the hypothesis that coordinate chest compression and ventilation may     minimize the increasement of airway pressure and improve the effect of circulation   "
93940|NCT02056496|"     Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized     by the human gut microbiota to yield a number of metabolites called urolithins (mainly     Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities.     However, the bioavailability of ellagic acid has been reported to be very low and the     existing studies are controversial so far. The investigators want to carry out a robust     (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of     pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be     administered. The investigators will analyze blood and urine samples using     UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:        -  The pharmacokinetics of EA.        -  The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins          production.   "
93941|NCT02056483|"     The purpose of this study is to examine if a psychosocial intervention including a nurse     navigator and systematic symptom screening may reduce psychological and physical symptoms as     well as health behavior after breast cancer.   "
93942|NCT02056470|"     Assess the safety and functionality of the Freedom Knee® system through a multi-center     clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data     for:        1. Range of Motion        2. Quality of Life measurements using Knee Society Scale (KSS)        3. Survivorship as defined by 'No Revision' of baseline implant        4. Quality of Life measurements using the WOMAC Score   "
93943|NCT02056457|"     The purpose of this study is to evaluate the effectiveness of selected healthy marriage (HM)     and responsible fatherhood (RF) grant programs, authorized by by the Claims Resolution Act of     2010. The programs are intended to improve the well-being of parents and families in domains     such as economic self-sufficiency, parenting, and healthy relationships.   "
94375|NCT02050802|"     The study is intended to demonstrate that macitentan does not have an effect on cardiac     repolarization exceeding the threshold of regulatory concern after repeated administration of     daily oral doses of 10 and 30 mg to healthy male and female subjects.   "
93944|NCT02056444|"     Bleeding during and after total hip replacement surgery is a primary concern to the surgical     and anaesthetic team. Tranexamic acid is a commonly-used drug that helps blood clotting and     decreases surgical bleeding. The investigators commonly administer the drug intravenously     prior to the procedure. Some patients are unable to receive the drug in this form, because of     risks related to blood clotting. The investigators know, from studies in total knee     replacement surgery, that the investigators can deliver tranexamic acid directly to the     surgical site (topically), with similar benefits and less of the drug absorbed into the     bloodstream, resulting in less risk to the patient. The investigators seek to find if similar     benefit in terms of reducing blood loss is seen using topical tranexamic acid in hip     replacement surgery. The investigators' hypothesis is that the topical form will be     equivalent, but not better than the intravenous form for reducing intra- and postoperative     bleeding. The investigators also expect to see decreased levels of tranexamic acid in the     bloodstream when it is administered topically.   "
93955|NCT02056301|"     The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling     pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be     the difference in pain scores at rest and with activity (coughing, deep breathing and     movement) during postoperative days 1 -5.   "
93956|NCT02056288|"     This study compares nerve blocks to IV pain medicines in children with broken arms. We are     trying to see if blocking the nerves in the broken arm results in better pain control and     less side effects than injections of morphine into a vein after surgery for a broken elbow.   "
93957|NCT02056275|"     To assess the effect of oral nutritional supplementation with dietary counseling versus     dietary counseling alone on growth of preschool children over a period of 90 days.   "
93958|NCT02056262|"     The primary objective of this study is to estimate the distribution of pathogenic species and     genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and     Assessment System) corresponding to the severity of dental caries among patients aged 3-45     years consulting in the Dentistry Departments of the Nîmes University Hospital and the     Montpellier University Hospital.   "
93945|NCT02056431|"     Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with     diabetes. People with painful DPN have trouble sleeping, participating in social events, and     conducting daily activities such as going to the store. Several prescription medications are     available for the treatment of DPN symptoms, but none work perfectly and all have side     effects that may be difficult for some patients.      When patients report their symptoms and side effects to their doctor, they provide the doctor     with important information to help them make adjustments to treatment that will help with     symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors     may encourage patients to make these changes on their own at home based on their experience     with therapy. However, patients may have a long time between visits to their doctor and may     have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit.      This clinical trial explores the possibility of computerized telephone calls to patients     (Interactive Voice Response, IVR, technology) to gather information about treatment     experiences that can then be reported to the doctor or used to guide patients to make changes     in how they take the medication. It addresses the following question: Can routinely asking     patients about their experiences with medications and using that information to encourage     clinically appropriate titration improve patient quality of life?      The investigators hypothesize that systematic collection and feedback of information about     DPN treatment preferences and experience from newly treated patients to their primary care     physician will facilitate treatment changes that improve patient outcomes   "
93946|NCT02056418|"     The pathogenesis of Crohn Disease (CD) is unknown, but there is evidence show that the     inadequate immune response or overreaction of the immune system against food antigens or     components of the commensal flora involve it. Corticosteroid therapy is effective for adult     patients with CD, but it has side effects and can't promote mucosal healing. In recent years,     Enteral nutrition (EN) is becoming primary therapy in induction and maintenance remission of     CD, especially in children. But the mechanism of EN in induction and maintenance remission of     CD is still unclear, and parts of patient have good clinical response to EN therapy while     other don't. So we design the study to explore whether EN treats CD by effecting intestinal     flora and whether the intestinal flora of patient with CD relates with clinical response.   "
93947|NCT02056405|"     Postoperative Ileus is defined as the transient postoperative functional inhibition of     propulsive bowel activity. The ethiology of this process can best be described as     multifactorial. In its pathogenesis different mechanisms are involved such as hormones and     neuropeptides, inflammation, narcotics and the Autonomic nervous system. Is one of the most     common causes of prolonged hospital stays after abdominal surgery, thereby increasing     health-care resource utilization. More importantly, it causes patient discomfort in the form     of nausea, vomiting, and stomach cramps. It has a variable duration but is usually solved in     3 to 4 days. Prolonged Ileus is associated with postoperative complications like an increase     on urinary and pulmonary infections, profound venous thrombosis and wound-site complications.      Mosapride is a prokinetic agent that acts as a selective serotonin agonist (5- HT4) that     facilitates acetylcholine release from the intrinsic plexus. This accelerates gastric     emptying and propulsive peristaltic movements on the lower intestines. Mosapride has no     action over the central nervous system therefore the lesser side effects like cardiac     arrhythmias and extrapyramidal symptoms. For being a safer drug we chose it to be the center     of our research.      Two randomized controlled trials studied Mosapride concluding it shortens PI after colorectal     surgery. However these trials took place on specific populations (Orientals) with less than     50 patients and only one of them included laparoscopic treatment specifically. Also the end     point of these studies didn't consider the impact of PI over hospital stay or costs to the     health system.      We therefore decided to conduct a prospective randomized study in patients undergoing     laparoscopic colorectal surgery for colon cancer. The patients will be randomized to receive     treatment or placebo after surgery. With this study we intend to prove that patients treated     with mosapride immediately after surgery suffer from shorter postoperative ileus with earlier     oral intake and shorter hospital stay.      The primary aim of the trial is to assess the effectiveness of the use of Mosapride in     shortening the duration of the Postoperative ileus in patients undergoing colorectal     laparoscopic surgery. The trial hypothesis is that the standardized use of Mosapride     immediately after colorectal laparoscopic surgery is safe and accelerates the recovery of     propulsive bowel activity, thereby shortening postoperative ileus and hospital stay.   "
93948|NCT02056392|"     Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc     interval in healthy male volunteers.   "
93949|NCT02056379|"     The study aims to analyze and compare the clinical effects of using inhaled budesonide or     intravenous dexamethasone in the treatment of postextubation stridor on children admitted to     the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert     Einstein.   "
93950|NCT02056366|"     The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in     people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the     nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may     cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.   "
93951|NCT02056353|"     Most critically ill patients are confronted with hyperglycaemia, which is associated with an     increased mortality and morbidity risk. Normalising these elevated blood glucose levels by     intensive insulin therapy may improve patient outcome, but is associated with an increased     risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised     software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia)     blood glucose control in critically ill patients than nurse-directed blood glucose control.   "
94026|NCT02055365|"     Vaccines have been responsible for preventing millions of deaths and extending the average     human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes     and associated functions that bring about protective immunity.This study aims to define     cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in     healthy individuals. The investigators hypothesize that many genes associated with innate and     adaptive immune functions are important for an effective HBV vaccine response.   "
93952|NCT02056340|"     Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in     the United States and causing as many as 500,000 deaths worldwide each year. Currently, there     are only a few treatments for influenza infection and none of these target inflammation that     can be caused by the virus. This study will test whether the anti-inflammatory effects of     statins, a class of drugs most often used to treat high cholesterol, will decrease the     severity of illness in patients who are infected with influenza by testing markers of     inflammation in the blood and recording resolution of influenza illness.   "
93953|NCT02056327|"     Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to develop     monitoring sensors that could be inserted into commercially available oral appliances in     order to monitor effectiveness of the oral appliances in treating sleep apnea.   "
93961|NCT02056223|"     Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in     preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin     or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA.     Aim of this randomized double-blind controlled study is to compare the efficacy and the     safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We     hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps     ameliorating the safety profile of the pharmacological treatment.   "
93962|NCT02056210|"     The objective of this study is to assess whether there are differences in the mobilization of     CD34+ cells and EPC in response to Mozobil in patients with diabetes mellitus compared to     subjects without diabetes. Currently, there are no non-invasive methods for the study of bone     marrow function in humans. This project aims to evaluate in patients with type 1 or type 2     diabetes mellitus the ability to mobilize CD34+ cells and EPC from the bone marrow to the     periphery in response to the exogenous mobilizing agent AMD3100 / plerixafor (Mozobil),     compared with a group of non-diabetic individuals. While it has been recently shown that     diabetic patients do not respond to mobilization induced by G-CSF (Filgrastim), the     investigators herein hypothesize that diabetic patients can adequately respond to     mobilization induced by Plerixafor   "
93963|NCT02056197|"     Motor control exercises have demonstrated a good option for recovery from chronic low back     pain. The purpose of this study is investigated the effectiveness of an exercise program for     trunk stabilization performed in stable and unstable surfaces for people with nonspecific     chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control group     will receive placebo treatment with shortwave; stable group will receive an exercise protocol     to stabilize the trunk on a stable surface and unstable group will receive the same exercise     protocol but performed on an unstable surface.      We hypothesized the unstable group will present pain reduction and functional improvement.   "
93964|NCT02056184|"     The purpose of this study is to determine whether therapy modifications (including addition     of ultrasound-guided treatment change) can change imaging results in patients with early     rheumatoid arthritis in a stable clinical disease activity state.   "
93965|NCT02056171|"     This study is designed to assess the safety and efficacy of quetiapine as treatment for     pediatric delirium.   "
93966|NCT02056158|"     In HIV+ cigarette smokers, with no prior history of pulmonary infections, emphysema is often     developed at an earlier age and is a significant cause of morbidity despite treatment with     antiretroviral drugs. Preliminary data gathered from HIV+ individuals that smoke cigarettes     strongly support the hypothesis that the combination of HIV infection and smoking creates     increased stress in the lower respiratory tract. To examine the underlying factors that     contribute to the accelerated development of emphysema in this cohort, samples from the lower     respiratory tract will be provided by HIV+ and HIV- subjects. The samples collected will     serve as biomarkers for assessing the onset of emphysema.   "
93968|NCT02056132|"     There is an urgent need for a noninvasive method to diagnose bronchial infections and     exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed     infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage     (BAL). However, some patients cannot produce sputum. At the same time the decision of when a     patient has an exacerbation continues to be very subjective. In this exploratory study, we     propose a new, noninvasive method to diagnose bronchial infections and to evaluate possible     markers of inflammation that can assist in a noninvasive way in the determination of     exacerbations.   "
93969|NCT02056119|"     Aerosol delivery during mechanical ventilation has long been a long debated topic. As     evidence- based knowledge about the delivery of aerosol to the lungs of mechanically     ventilated patients increases, one piece of the puzzle has remained unexplored; measurement     of clinically relevant outcomes. The primary aim of this research is to compare clinical     outcomes (ventilator- associated events (VAEs), length of stay (LOS) in intensive care unit     (ICU) and total days on mechanical ventilation) when using a traditional jet nebulizer versus     a newer generation vibrating mesh nebulizer during mechanical ventilation. The secondary aim     of this research is to identify source of bacteria by obtaining cultures of each nebulizer     and ventilator circuit and plating them for colony growth and identification.   "
93970|NCT02056106|"     This study compares two models for implementing antidepressant treatment in 10 HIV clinics in     Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized     model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine     depression screening at each clinic visit for all adult patients by trained expert patients     at triage, (2) training nurses to diagnose depression and prescribe and monitor     antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and     monitoring by hired study psychiatrists. The clinical acumen model also includes routine     depression screening and ongoing supervision, but it relies on the clinical acumen of trained     primary care providers to further evaluate and treat patients who show signs of depression at     screening, as opposed to a structured protocol. The primary aim is to test the hypothesis     that the nurse-driven protocolized model will result in greater uptake of antidepressant     treatment and better quality of depression care outcomes. The study will also test the     hypotheses that treatment of depression results in improved HIV treatment adherence, work     functioning and consistent condom use.   "
93971|NCT02056093|"     In spontaneously breathing mechanically ventilated patients, the adequacy between the     patient's demand and the level of respiratory support delivered by the ventilator is a major     clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist     ventilation (PAV) have been developed to adapt the level of assistance to the patient's     demand. These two modes have been compared to pressure support ventilation (PSV) but have not     been compared to each other.   "
93972|NCT02056080|"     A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit     of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive     Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January     2005 and December 2011   "
93973|NCT02056067|"     The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor     positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months     and are experiencing at least mild arthralgia originating during AI treatment, the yearlong     effect of exercise vs. attention control (health education), and on toxic side effects of AI.   "
93976|NCT02056028|"     The definition of biliary fistula is heterogeneous and the more accepted is that proposed by     the ISGLS. We devised a precise definition of post-resectional biliary fistula and a     well-established policy both for its disclosure and management.Aim was the validation of our     definition, and management of biliary fistula after hepatic resection in a large prospective     cohort of patients and its comparison with that of the International Study Group of Liver     Surgery (ISGLS).   "
93977|NCT02056015|"     This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to     assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of     [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic     Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their     treatment plan will be eligible for enrollment.   "
93978|NCT02056002|"     Fragmentation of care can lead to poor treatment adherence in patients with chronic medical     conditions which can, in turn, lead to adverse health consequences, poor quality of life, and     patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient     education, time delays in delivery of care, lack of adequate healthcare coordination, or     difficulty accessing various healthcare providers across a front desk which serves as a     healthcare bottle-neck. Better efficiency in healthcare delivery, with greater connectivity     through knowledgeable and trained peer volunteers and inexpensive cell-phones integrated by a     smart telephone exchange may alleviate some of the care and communication burden faced by the     healthcare system. Specifically, such community health education volunteers (peer-buddies)     who are experienced in managing their disease condition may be able to impart knowledge and     confidence to a recently diagnosed patient in a much more personalized manner than that of a     group therapy session. An additional important advantage is the peer-buddy's ability to     relate to the patient in a manner consistent with their social, ethnic, and cultural believes     without language barriers or differences that may stem from socioeconomic strata. We will use     sleep apnea as an example condition to test the effect of a peer-buddy helper (combined with     the universal availability of personal cell phones) on the problem of poor care coordination     and treatment adherence to the CPAP treatment for sleep apnea. Sleep apnea is a very common     condition that affects 7-12% of the US population, and if left untreated, can lead to poor     health and even death through its effects on high blood pressure, heart disease, stroke, and     motor vehicle accidents. Fortunately, CPAP therapy can lead to a 3-fold reduction in such     consequences, but patient adherence to such CPAP treatment is generally poor. We have     recently completed a small study that demonstrated improved usage of CPAP treatment by     patients receiving help from a peer-buddy with excellent results. We propose to further     enhance the peer-buddy community-volunteer concept in our proposed research by combining     this with cell-phone technology and a telephone exchange that improves access to healthcare     providers, technicians, and home care companies. We hope to show that active community     participation by experienced lay individuals assisted by the universal availability of     cheap cell-phones can improve the reach and effectiveness of our healthcare system in     improving the health and well-being of our patients. If successful, such an innovative and     community-based approach can be applied to other chronic medical conditions.      Hypothesis #1: We hypothesize that patients in the peer-driven intervention with interactive     voice response (PDI-IVR) group will experience a greater patient satisfaction (measured by     Likert scale64,70 and PACIC71,72) and perception of care coordination (measured by CPCQ72,73)     than patients in the usual care (control) group.      Hypothesis #2: We hypothesize that patients in the PDI-IVR group will experience a greater     CPAP adherence (measured by device download), patient activation (PAM), and self-efficacy     (SEMSA) than patients in the usual care (control) group.      Hypothesis #3: We hypothesize that patients in the PDI-IVR group will experience greater     improvements in HR-QOL (measured by FOSQ) vigilance (psychomotor vigilance testing) and blood     pressure than patients in the usual care (control) group.   "
93979|NCT02055989|"     This study is a phase I/II dose escalation trial designed to test the feasibility of     delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety     and possible improvement in outcome when the dose is increased.      This protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/     hypopharynx cancer patients. These two groups of patients are being treated differently and     will be analysed separately.      The primary objective of this Phase I sequential cohort study was to determine the     feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced     high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2     dose fractionation regimens.      DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions      DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily     fractions and elective nodal levels 54 Gy in 30 daily fractions   "
93980|NCT02055976|"     The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C)     lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two     weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a     stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose     LDL-C is not controlled.   "
94027|NCT02055352|"     To demonstrate the free combination of budesonide and indacaterol is as efficacious as     fluticasone and salmeterol in patients with COPD   "
93982|NCT02055950|"     Trends in organ donor pool are characterized by an increasing age and a shift towards     cerebrovascular diseases as primary causes of death. As a result, donors older than 60 years     nowadays represent more than one fourth of the entire donor pool in Italy. This, along with     an increasing number of patients on the waiting list for transplantation, prompted a growing     use of organs from subjects older than 60 years that would have been considered unsuitable     years ago. To improve graft outcomes, transplant of two older kidneys in the same recipient     has been proposed. To optimize allocation of these organs to single or dual transplantation,a     scoring system for kidneys, based on biopsy, with scores ranging from a minimum of 0     (indicating the absence of renal lesions) to a maximum of 12 (indicating the presence of     marked changes in the renal parenchyma) has been suggested. According to this panel, kidneys     with a score of 4 or lower are predicted to contain enough viable nephrons to be used as     single transplants, those with a score of 5, 6, or 7 can be used as dual transplants, kidneys     with a score greater than 7 are discarded. The survival of kidney grafts obtained from donors     older than 60 years and allocated for single or dual transplantation on the basis of biopsy     findings before transplantation was similar to that of single grafts from younger donors. To     further improve these results, set-up of strategies to preserve organs is crucial to save the     residual nephron mass and optimize outcomes of these marginal grafts. In this regard, over     the past 30 years two methods of kidney preservation have been developed. With cold storage,     the kidney is flushed once it is removed from the donor and placed in an ice-cooled container     with preservation solution. With the use of pulsatile machine perfusion, the kidney is     connected to a machine, which pumps a cold solution containing oxygen and nutrients through     the kidney. This process allows for metabolism to continue in the kidney with end products     being removed. The broad aim of the present study is to evaluate whether pulsatile machine     perfusion of kidneys from older/marginal donors may provide better outcomes than static     perfusion. To this purpose the outcome of recipients of perfused kidneys will be compared     with the outcome of historical controls receiving non-perfused kidney selected and allocated     on the basis of the same criteria and matched by gender, age and kidney histologic score.   "
93983|NCT02055937|"     The purpose of this study is to study the impact of the immediate implant breast     reconstruction for patients with mastectomy and postoperative chest wall radiotherapy   "
93984|NCT02055924|"     This is an open label, multicenter, dose escalation, phase Ib study to determine the     recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of     ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients     with B-cell malignancies. This dose escalation will be followed by an exploratory expansion     phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C).      During Part 1 Dose Escalation, the 3+3 design will be applied. Three doses of ibrutinib     (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation     Committee. Dose escalation will begin at dose level 1 = 420 mg.      The dose escalation will be performed for two types of associations in four separate groups :        -  Group A : ibrutinib D1-D21+ R-DHAP        -  Group B : ibrutinib D1-D21 R-DHAOx        -  Group Abis : ibrutinib D5-D18+ R-DHAP        -  Group Bbis : ibrutinib D5-D18 R-DHAOx      This dose escalation will be followed by an exploratory expansion phase in the same 2 groups     A/Abis and B/Bbis plus a third one including only mantle cell lymphoma (MCL) in first line     patients: group C. Patients included in the Group C will receive ibrutinib in combination     with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion     of each patient.   "
93985|NCT02055911|"     To evaluate the safety of intravitreal ranibizumab repeated injections in patients with     diabetic macular edema regarding maintenance of retinal ganglion cell function.   "
94000|NCT02055703|"     This study will be a single-center, open-label, drug-drug interaction study in healthy male     and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of     itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be     assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole     or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the     effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in     approximately 18 subjects. In Part C, the effects of donepezil administered in combination     with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in     approximately 24 subjects.   "
94001|NCT02055690|"     The first part of this study is to find the recommended dosages of a combination of two     drugs: pazopanib and fosbretabulin, which will be given to female patients with relapsed     ovarian cancer.      The second part of the study involves comparing the recommended dose of pazopanib and     fosbretabulin in combination against pazopanib alone in female patients with relapsed ovarian     cancer to determine whether the combination is more beneficial that pazopanib on it's own.   "
93986|NCT02055898|"     Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment     and other symptoms, is associated with neither a currently identifiable disease process nor     major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep     impairment is common in nearly everyone with CFS, with both daytime sleepiness and     unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be     that fundamental regulatory processes that control sleep are disturbed in CFS, leading to     different effects on sleep and daytime symptoms depending on the subject's prior sleep,     daytime routine, medication and other factors. The investigators contacts with patient groups     have indicated that patients are generally confident that on days when their sleep is better     they perform better in the day. There is growing evidence that deep, slow wave sleep (SWS) is     altered in CFS, and this may suggest impairment of build up of sleep pressure during the day.      The investigators wish to investigate whether enhancement of SWS, which is seen after a drug     called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function,     specifically sleepiness and mental performance. This is a safe and well-tolerated drug that     is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.      The investigators will study 12 patients diagnosed with CFS using international diagnostic     guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on     the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be     taken nightly, and the investigators will measure next-day sleepiness, mental performance and     fatigue, and compare drug and placebo nights.   "
93987|NCT02055885|"     In the literature, the effects of acute oxygen administration on exercise tolerance and     related symptoms have often appeared to be contradictory. Some investigations have reported     benefits from acute oxygen supply during exertion, including increased exercise performance,     reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have     reported no improvement. Recently, we advanced then the hypothesis that some patients would     be non-responders and even worsen under oxygen treatment. The preliminary results confirmed     our hypothesis since we demonstrated that while 56% of the patients were improved with     supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased     performance and increased dyspnea during endurance exercise with supplemental oxygen).     However, this was a pilot study offering preliminary insights and tentative conclusions that     must be confirmed in a larger case series.      The aims of this retrospective study was :        1. To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the          deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy          treatment) and non-LTOT patients who exhibit exercise desaturation.        2. To identify the predictive factors among the clinical data (i.e., anthropometric,          spirometric and gazometric data) and/or functional data recorded during rehabilitation          program   "
94114|NCT02054208|"     This combined phase 1/2a clinical trial is to investigate the safety, dose limiting toxicity     (DLT), and exploratory efficacy of three repeated intraventricular administrations of     NEUROSTEM® (human umbilical cord blood-derived mesenchymal stem cells) versus placebo via an     Ommaya reservoir at 4 week intervals in patients with Alzheimer's disease.   "
94115|NCT02054195|"     This study aimed to compare special guided training model with standard procedure on     insertion technique for post-placental intra uterine device that provides IUD location close     enough to fundal part of uterus to prevent expulsion   "
93988|NCT02055872|"     Critically ill patients usually require intravenous fluids to correct low blood pressure and     improve blood flow to vital organs. However, once the patient's blood pressure has improved,     these fluids can leak out into various organs, including the lung, kidneys, and skin. Excess     fluid in these tissues, called edema, has been associated with longer ICU stays and higher     mortality. Thus removing excess fluid is an important goal. The simplest way to treat edema     is to use diuretics, such as furosemide, which increase urine output.      To further improve urine output, patients are sometimes given albumin, a protein which helps     to suck fluid out from the tissues, and keep it in the blood vessel, where it can be filtered     in the kidney and removed in the urine. Although albumin is often used for this purpose,     there is little evidence to support it. A large randomized controlled trial is needed to     determine if albumin plus furosemide is truly more effective than furosemide alone in     critically ill patients with low levels of blood albumin. We will perform a pilot study to     assess the feasibility of such a trial.   "
93989|NCT02055859|"     Most vestibular schwannomas are benign and slow-growing. Based on that fact, conservative     management with serial imaging is a viable alternative. For patients who undergo treatment     because of tumor growth, progressive symptoms, or personal preference, options include serial     observation, microsurgical resection, fractionated stereotactic radiotherapy, and     stereotactic single-session radiosurgery.      Despite improved radiosurgical techniques and lower marginal doses, a recent report has shown     a somewhat disappointing 10-year actuarial hearing preservation rate of 44.5%, with hearing     loss developing as much as 6 years after.      Fractionation of the prescribed dose may takes some advantages from radiobiologic principles     to reduce toxicity and maintain tumor control.      Staged frame-based radiotherapy using a 12-hour interfraction interval was successfully used     at Stanford university and has shown a hearing preservation rate of 77% at 2 years of     follow-up.      The aim of the present protocol is to evaluate the hearing preservation, the local control     and toxicity after single-session (sSRS) or multi-session (3 fractions) radiosurgery (mSRS)     by using the frameless robotic CyberKnife® system (Accuray Incorporated, Sunnyvale, CA, USA).      In order to investigate about this a randomised controlled double harm (sSRS vs mSRS) trial     was designed.   "
94002|NCT02055677|"     Main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and     vegans with respect to their personality profiles, values and empathy through validated     questionnaires. Main hypothesis: vegans and ovo / lacto-vegetarians differ in their     personality, empathy and values   "
94003|NCT02055664|"     This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block     with continuous infiltration of ropivacaine versus placebo.      Procedure:      Once consent has been obtained, patients will be randomised into one of the two groups:     Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a     catheter inserted by the anaesthetist.   "
93990|NCT02055846|"     Prostate cancer (PC) represents one of the most common cancers in industrialized countries.     Patients with localized disease may be treated with surgery or radiation, while androgen     ablation is used as first-line therapy in patients with metastatic disease. While most     patients initially respond well to this hormonal therapy, they most ultimately become     unresponsive and recur within 2 years as androgen-independent prostate cancer (AIPC).     Recently, docetaxel-based regimens have demonstrated improved survival in men with AIPC in     two different, large, phase III studies. However, the median overall survival was prolonged     for only 2 or 3 months. Androgen independent (AI) progression involves variable combinations     of clonal selection, adaptive up-regulation of anti-apoptotic genes, ligand-independent     androgen receptor (AR) activation, alternative growth factor pathways, and immune system     escape. Additional therapeutic strategies targeting molecular mechanisms mediating     resistance, combined with immunotherapy must be developed. One strategy to improve therapies     in advanced PC involves targeting genes that are activated by androgen withdrawal, either to     delay or prevent the emergence of the resistant AI phenotype. Recently, a     scientist,identified Heat Shock Protein (Hsp27) as a highly over-expressed gene in AIPC.     Hsp27 knockdown using antisens oligonucleotides (ASO) and small interfering RNA (siRNA)     increased apoptotic rates and enhanced hormone- and chemo-therapy in PC. She developed and     patented a 2nd generation ASO targeting Hsp27 that has been licensed (investigational drug     called OGX-427) and clinical trials phase I/II is currently in process in PC. Despite OGX-427     efficiency, the functional role of stress induced Hsp27 in castration or chemotherapy-induced     apoptosis remains undefined. The purpose of this study is to elucidate the pathways leading     to Hsp27 action in androgen-independent prostate cancer in order to 1/ Increase the     pharmacological safety of OGX-427 and 2/find new specific therapeutic targets and treatment     strategy for androgen-independent prostate cancer .   "
93991|NCT02055833|"     In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with     impaired quality of life, reduced survival, more frequent treatment interruptions and dose     reductions. The international guidelines recommend early nutritional support in the presence     of nutritional risk, as it allows preventing or treating malnutrition and improving the     clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional     intervention trials in head-neck cancer patients have been conducted on small samples and did     not clarify the role of oral nutritional supplements (ONS). Accordingly, although current     guidelines recommend as grade A the use of ONS associated with dietary counseling for     head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still     needs to be evaluated in adequately sized and randomized clinical trials.   "
93992|NCT02055820|"     This is a multicenter, open-label, dose-finding study of venetoclax administered orally in     combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide,     doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's     Lymphoma (NHL). The study will consist of 2 stages: a dose-finding Phase Ib stage and a Phase     II expansion stage. In the Phase I portion of the study, participants will be randomized to     one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in     combination with G-CHOP (Arm B) and will explore the doses of venetoclax in combination with     R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP     and G-CHOP will be determined during the dose-finding stage. For the Phase II portion of the     study, the venetoclax dose for venetoclax + R-CHOP is on a non-continuous dosing schedule as     determined by the Phase Ib portion of the study based on safety and tolerability observed in     participants treated in the dose escalation portion of the study.   "
93993|NCT02055807|"     The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during     laparotomy will limit the development of atelectasis and therefore improve the aeration     score.   "
93994|NCT02055794|"     The goal of this research is to investigate three different methods of perineal skin closure     during second-degree perineal wound repair and determine which method is associated with the     least amount of patient pain.      Null hypothesis: There will be no difference in patient pain among the three different     methods for second degree perineal wound repair.   "
93995|NCT02055781|"     The primary hypothesis of the study is that treatment with either once-daily or twice-daily     pacritinib results in a greater proportion of patients with thrombocytopenia and     myelofibrosis achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than     treatment with Best Available Therapy, and a greater proportion of patients achieving a ≥ 50%     reduction in total symptom score from baseline to Week 24 as measured by the     Myeloproliferative Neoplasm Symptom Assessment Form 2.0.   "
93996|NCT02055755|"     The goal of this project to begin using a wound research database with clinical decision     support features at Winthrop University Hospital. A research database is an electronic     computer system that is used to collect patient information. Clinical decision support is the     ability for a computer system to provide medical assistance to the doctor through alerts and     recommendations based on the information entered. The investigators believe that use of a     wound clinical decision support tool, much like a drug, will improve healing in patients     diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness caused     by these wounds. In order to develop a useful clinical decision support tool, investigators     first need to develop a large research database to determine the data points important for     wound healing. The investigators will be using the data collected in this study for future     research and publication. Data will be reviewed to answer questions important to diabetic     foot ulcer healing and for the purpose of developing the clinical decision support alert     system.      After providing informed consent, participants will be asked a series of questions related to     their past medical history, and relevant wound data will be collected. Study staff will     photograph the wound at baseline, and once per week until the wound is completely healed, or     for a duration of six months.      Participants will be expected to return to Winthrop University Hospital for wound follow-up     on a regular basis, or as determined by the Principal Investigator.   "
93997|NCT02055742|"     To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10,     with male urine, female urine, physician-collected (medical professional) endocervical swabs     and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.   "
93998|NCT02055729|"     The main objective of this study is to characterize the evolution (over a period of 28 days)     of superficial and deep bacterial skin flora in patients with stage 3 or 4 sacral pressure     ulcers (bedsores). Changes in terms of pathogenic, potentially pathogenic and non-pathogenic     bacterial species at the intra-individual and population levels.   "
93999|NCT02055716|"     To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male     volunteers over 7 days with qd or bid dosing   "
98644|NCT01994993|"     The main purpose of this study is evaluate whether it is safe or not to use various     combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam,     gentamicin) in treating infants with complicated intra-abdominal infections   "
94004|NCT02055651|"     Introduction: As employees spent most part of their time at the worksite, it provides a venue     to address multiple individual risk factors and promote health. The America Heart Association     (AHA) defined cardiovascular health using as metrics smoking status, body mass index,     physical activity, diet, total cholesterol, blood pressure and fasting blood glucose.      Objective: Evaluate Bayer employees' cardiovascular health according to the AHA definition     and the acceptance to engage in lifestyle change programs.      Methods: By the time of the annual occupational safety periodic medical examination,     employees will receive an email with information about the cardiovascular health screening,     exams requisition (fasting blood glucose and total cholesterol) and a copy of the written     informed consent. If the employee accepts to participate, after providing a written informed     consent, he will be evaluated according to the AHA cardiovascular health metrics. Data will     be collected at the occupational safety electronic health record. After medical evaluation,     employees will receive a printed feedback with their cardiovascular health score and will be     referred to indicated lifestyle change programs (healthy weight, smoking cessation, diabetes     control, high blood pressure control, dyslipidemia control).      After 12 months we will evaluate the percentage of employees who accept to participate;     prevalence of the cardiovascular risk factors and distribution according to the AHA     classification in ideal, intermediate and poor; adherence to lifestyle change programs.   "
94005|NCT02055638|"     This study is designed to explore the safety and tolerability, and to compare the activity of     SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED).      Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a     two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will     be randomized to either SRX246 or Placebo treatment groups.      Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits     throughout the trial. The study results will be determined based on any changes observed over     the study period.   "
94116|NCT02054182|"     The purpose of this study is to determine whether vitamin D supplements given to children     aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will     improve symptoms and reduce the duration of hospitalization.   "
95538|NCT02035618|"     Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial     effects on scapular kinematics, myofascial pain and function in subjects with shoulder     impingement when compared to exercises only.   "
94006|NCT02055625|"     Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem     cell transplantation (HSCT), and is classified as acute (aGVHD) or chronic (cGVHD). aGVHD     onsets within the first 100 days after transplant or with clinical features including     erythema, liver dysfunction and oral mucositis, whilst cGVHD or persistent GVHD occurs in     approximately 30-60% of transplant patients who survive their first year . Long-term     five-year prognosis for cGVHD patients is poor with a 70% mortality rate. cGVHD manifests as     an autoimmune-like disease affecting multiple sites, including skin, mouth, eyes,     gastrointestinal tract, liver, and joints. The oral cavity is the second most common site to     be affected with symptoms in 45-83% of cases. In the mouth a diverse spectrum of clinical     features can be found for example mucosal lesions can affect almost any site, salivary gland     dysfunction and restricted mouth opening. Short-term patients can experience mucosal     sensitivity, malnutrition, problems speaking, increased caries risk, xerostomia, oral pain     and a diminished quality-of-life. Long-term complications include secondary malignancies and     perhaps early death. Clinical management seeks to alleviate the symptoms and improve     quality-of-life but 50% of patients fail front-line systemic steroid therapy. Oral cGVHD can     be treated with topical high potency corticosteroids and oral rinses, however these     treatments are not always effective and carry a risk of systemic absorption. Mesenchymal     stem/stromal cells (MSCs) resident in adult and fetal tissues, such as the bone marrow have     the capacity to form bone, cartilage, stroma, muscle and fat, are known to exhibit     immunosuppressive and immunoregulatory properties both in vivo and in vitro. MSC infusions     have been used to treat disorders such as osteogenic imperfecta, cardiovascular disease and     to heal large bony defects. Indeed, the immunosuppressive capacity of MSCs have led to     infusions being used as a second-line treatment for GVHD patients, and our group has shown     within a Phase II clinical trial, 55% aGVHD patients who failed front-line steroid treatment     responded to MSC infusion these studies are going with cGVHD patients. The goal of this     project is to perform a pilot study to determine whether MSC injections directly into mucosal     lesions in patients with oral cGVHD are able to alleviate the symptoms and facilitate the     reparative process.   "
94007|NCT02055612|"     The aim of the study is to find out prevalence of aged-related macular degeneration (AMD) in     Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of wet     form of AMD in relation to demographic data, patient´s anamnesis, nutrition, co-morbidities     etc.   "
94008|NCT02055599|"     The goal of this project to begin using a wound research database with clinical decision     support features at Winthrop University Hospital. A research database is an electronic     computer system that is used to collect patient information. Clinical decision support is the     ability for a computer system to provide medical assistance to the doctor through alerts and     recommendations based on the information entered. The investigators believe that use of a     wound clinical decision support tool, much like a drug, will improve healing in patients with     chronic wounds (wounds that fail to heal over the course of weeks) and ultimately lower the     risk of death and illness caused by these wounds. In order to develop a useful clinical     decision support tool, investigators first need to develop a large research database to     determine the data points important for wound healing. The investigators will be using the     data collected in this study for future research and publication. Data will be reviewed to     answer questions important to wound healing and for the purpose of developing the clinical     decision support alert system.      After providing informed consent, participants will be asked a series of questions related to     their past medical history, and relevant wound data will be collected. Study staff will     photograph the wound at baseline, and once per week until the wound is completely healed, or     for a duration of six months.      Participants will be expected to return to Winthrop University Hospital for wound follow-up     on a regular basis, or as determined by the Principal Investigator.   "
94009|NCT02055586|"     This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission     tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with     metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic     procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during     treatment.   "
94010|NCT02055573|"     Regular reading with young children strengthens the parent-child relationship and builds     their language, literacy and social emotional skills. Parent knowledge of normal variation of     infant crying and of the dangers of shaking a baby as well as their ability to cope with     infant irritability are likely factors in their successful adjustment to parenthood and the     prevention of this tragic act.      Purpose: Identify easily implementable interventions for economically disadvantaged mothers     in the newborn period which 1) Promote early literacy behaviors and early nurturing     parent-child relationships and 2) Increase mother's knowledge of normal crying patterns, the     dangers of shaking a baby and her ability to cope with parenting stresses.      Design/Methods: A convenience sample of 300 low income (insured by Medicaid) new mothers of     healthy singleton, full term infants in the level 1 mother/baby unit at Women & Infants     Hospital will be invited to participate in a Randomized Controlled Trial study of educational     videos and materials for parents. They will be randomized into one of two intervention     groups. 1) The Ready to Learn (RTL) arm will receive a DVD in both Spanish and English and a     bilingual booklet (both produced by Parents' action for Children) addressing the benefits of     reading, talking and playing with young children, as well as a new children's board book. 2)     The All Babies Cry (ABC) arm will receive a DVD in both, Spanish and English and a bilingual     booklet (both produced by VIDA) explaining crying as part of normal infant behavior,     highlighting signs of parental distress and providing strategies to sooth parents and their     children. We will enroll 75 mothers who speak Spanish primarily at home in each intervention     group, as well as 75 mothers who speak primarily English. The RTL mothers will serve as     controls for the ABC mothers and vice versa. Before reviewing the materials, mothers will be     asked to respond to a baseline interview with socio-demographic information, questions     regarding Early Literacy promotion, reading with children and their own reading habits as     well as general knowledge on the prevention of shaking a baby and handling their own stress.     Follow up phone interviews will be conducted by a bilingual research assistant blind to the     intervention status at 2-5 months post-partum containing similar questions. Consenting     mothers will receive a bag of diapers at the completion of enrollment interview as an     incentive for participating in the study. Data will be entered into Excel and transferred     into STATA for analysis. Frequency counts will be generated for demographic, literacy related     and parental knowledge and stress variables in the two intervention arms. Chi-Square and     T-tests will be used to compare literacy and parental knowledge outcomes for each     intervention group at both follow up interviews.      Hypotheses: 1) Mothers in the RTL branch will recognize the importance of reading to their     babies, initiating this activity at earlier ages and reading more often with them. 2) Mothers     in the ABC branch will gain an understanding of crying as part of normal infant behavior and     build strategies to sooth themselves and their newborns.   "
94206|NCT02053012|"     The investigators feel that children who have OSA or sleep-disordered breathing may have a     different reaction time than normal variants. Children who have OSA are known to have     behavioral and sleep patterns that are different. It makes sense their reaction time may be     different than normal as well. We plan to measure reaction times via a 10 minute psychomotor     vigilance test device in children who snore who are coming in for a sleep study or for     adenotonsillectomy.   "
94011|NCT02055560|"     The primary objective of this study is to evaluate whether the management of colorectal     cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU     related toxicities and improves outcomes compared to the current standard of care. A     secondary objective is to characterize the variability of 5-FU levels among CRC patients     managed with 5-FU exposure optimization testing and the impact of such management on 5-FU     plasma levels and drug doses during the course of chemotherapy.   "
94012|NCT02055547|"     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     MK-8521. The primary hypothesis is that MK-8521 is sufficiently safe and well-tolerated in     healthy, lean and obese males.   "
94013|NCT02055534|"     Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL)     amyloidosis and has been associated with mortality and impaired quality of life (QoL). We     investigated whether nutritional counseling is beneficial to the maintenance of nutritional     status and QoL in AL outpatients.   "
94014|NCT02055521|"     Composite tissue allotransplants (CTA) involve transplantation of various tissues including     vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. The     large majority of recipients have been maintained on immunosuppression therapy similar to     that used in solid organ transplantation that is associated with the complications usually     reported in solid organ transplantation. The question whether risks associated with     indefinite immunosuppressive are justified for a non-lifesaving procedure still remains     unanswered. At present no CTA recipient proved to be spontaneously tolerant with any     immunosuppressive protocol; indeed, until now all recipients who discontinued the     immunosuppressive therapy rejected their graft. On the other hand CTA recipients showed a low     incidence of chronic rejection despite the high incidence of acute rejection episodes.      For all these reasons it should be of great interest to minimize the immunosuppression in CTA     patients knowing their immunologic risk. The main outcome of this study is to search for     the signature of tolerance in recipients of hand or face allotransplantation testing     biomarkers previously identified in operational tolerant kidney transplant recipients.      These markers have been developed studying tolerant kidney recipients and they were already     tested in five bilateral hand transplantations and one face transplantation.      The present study will include hand and face allograft recipients transplanted at least one     year in several European institutions (Innsbruck, Lyon, Monza, Valencia): 11 bilateral hand     transplantations, 4 single hand transplantations and 3 face transplantations. All the     patients will undergo B cell phenotyping, TCR repertoire, molecular signature from     operational tolerance and a skin biopsy with immunohistochemical staining of the specimens in     order to show signs of acute or chronic rejection.      The results could provide a valid tool to detect operationally tolerant recipients as well as     recipients prone to develop chronic rejection.   "
94117|NCT02054169|"     Delirium is common in older emergency department (ED) patients and often remains     unrecognized. Existing instruments to detect delirium are often time consuming and therefore     not feasible in the busy ED setting In this study the investigators tested the feasibility of     the newly developed modified confusion assessment method (mCAM-ED).   "
94505|NCT02049112|"     The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of     our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness     as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® &     Biotene®) in patients with xerostomia due to chronic hyposalivation.   "
94015|NCT02055508|"     The investigators plan to evaluate, in a randomized, controlled phase III trial in patients     with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise     intervention program (EIP) on quality of life, physical functioning and immune function     parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases,     Heidelberg, over a time period of two years and followed up for a total of 12 months.      Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC     alone (besides a proper symptom and side effect management CMPC ensures the potential     influence of social contacts that can be anticipated for the patients in the intervention     group).      Our primary aims are to investigate whether a combination of a partly supervised (in- and     outpatient) and partly home-based endurance and resistance training improves quality of life     (QoL) and lowers levels of fatigue (evaluation via the standardized and validated     questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on     tumor specific immune responses. Biomarkers of immune function will be measured by cellular     immunity and cytokine and chemokine panels.      Further secondary outcomes include measurement of anxiety, depression and demoralization,     physical performance parameters (e.g. improvement in walk distance, muscle strength), as well     as overall and progression free survival analyses.      The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in     patients with advanced NSCLC with the results being utilized in the design of the here     proposed trial.      The investigators hypothesize that patients randomized in the exercise intervention group     will show improved QoL and reduced fatigue, as well as improved physical functioning and     increased tumor specific immune responses.   "
94016|NCT02055495|"     There is no consensus on the surgical treatment of unremitting, painful flatfeet in children.     Subtalar arthroereisis has gained notoriety although there is a paucity of literature on its     biomechanical effects. The goal of the investigators was to compare a group treated with     subtalar arthroereisis with another group undergoing lateral column calcaneal lengthening.     The investigators hypothesis was that the results of arthroereisis would be equivalent to the     more established method of calcaneal lengthening.   "
94017|NCT02055482|"     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a     general term that means that the kidneys are not functioning to their full potential. The     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to     produce erythropoietin.      The purpose of this extension study is to find out if the study drug, a tablet taken orally,     is safe and effective for the treatment of anaemia associated with chronic kidney disease.      The extension study will enroll up to 240 patients at multiple locations in Europe, Asia and     Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part     in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and     the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16     weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with     visits every 4 weeks. During these scheduled visits patients will undergo a number of     procedures to confirm efficacy and safety of the study drug, including measurement of heart     rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample     collection for laboratory tests.      The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this     research. This study will include subjects who either completed the treatment period in their     respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping     event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study,     subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension     study.   "
94018|NCT02055469|"     In patients with achalasia, the relationship between the perception of dysphagia, oesophageal     emptying, lower oesophageal sphincter (LOS) distensibility and oesophageal circular and     longitudinal muscle contraction is not clear.      We aim to characterize oesophageal circumferential and longitudinal muscle contractility and     LOS distensibility in patients with achalasia (either before or after treatment). This may     allow an understanding of the mechanisms underlying persistent dysphagia and delayed     oesophageal emptying after treatment.   "
94207|NCT02052999|"     The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of     Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea   "
94019|NCT02055456|"     Decrease in blood cell counts due to deficient bone marrow function, called bone marrow     failure, as well as some lung diseases, called idiopathic pulmonary fibrosis, can be caused     by genetic defects in telomere biology genes, eventually causing telomere erosion. These     disorders are collectively termed telomeropathies.      There is evidence that male hormones may improve blood cell counts in marrow failure, and     these hormones are able to stimulate telomerase function in hematopoietic cells in vitro. We     propose this study to the use of male hormone in patients with aplastic anemia and pulmonary     fibrosis associated with defects in telomeres.   "
94020|NCT02055443|"     The purpose of this study is to evaluate whether new novel markers from the clinical     electrocardiogram (EKG), which have been used as non-invasive measures of heart disease, can     detect coronary artery disease in patients with chest pain. The researchers are especially     interested in studying how changes in these unique waves evolve over time with rest and     activity. It is hoped that the findings will be helpful in differentiating patients with     cardiac chest pain at emergency departments from those with non-cardiac chest pain, as early     identification can accelerate treatment and save lives.      Eligible participants are those age 18 and older who have been referred for a nuclear stress     test at University of Pittsburgh Medical Center Presbyterian Hospital to rule out coronary     artery disease as part of their clinical care.   "
94021|NCT02055430|"     To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary     drainage in children   "
94022|NCT02055417|"     In this 3-year study, the investigators will develop and pilot test an intervention called     Personal Approaches to Treatment Choices for HIV (PATCH). PATCH is a brief intervention     designed to support participants' decision-making processes and enhance intrinsic motivation     to initiate ART, using motivational interviewing (MI) techniques. The intervention will be     targeted at HIV-positive African-American adults in inner-city Baltimore, Maryland who are     suboptimally engaged in care and who endorse conspiracy beliefs about HIV or low readiness to     begin ART. The specific aims are: (1) Develop and refine a manual for a brief MI intervention     to support ART decision-making and reduce the likelihood of ART refusal: (2) Evaluate the     feasibility and acceptability of implementing the PATCH intervention in a small sample of     individuals who are African-American, recommended for ART but who are not current taking it,     and who experience multiple barriers to ART adherence; and (3) Conduct a small randomized     controlled pilot to test the potential efficacy of the PATCH intervention in producing     positive attitudinal changes, including a reduction in conspiracy beliefs and perceived     barriers to ART and stated readiness to begin ART.   "
94023|NCT02055404|"     The purpose of this study was to select the size of the molded rotation mark for a new toric     contact lens by comparing the visibility of various molded rotation marks.   "
94024|NCT02055391|"     The purpose of this study is to determine whether a new weight loss treatment which     incorporates behavioral weight loss skills and skills for learning how to identify, manage,     and cope with emotions helps with weight loss and emotional eating in people who are     overweight and eat in response to emotions.   "
94028|NCT02055339|"     Preterm infants born before 28 weeks gestation are at risk for lung disease and require     oxygen and pressure to keep their lungs open. This usually involves a device called nasal     continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they     are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not     started due to concerns for choking. This may cause them to miss their window of learning and     may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from nCPAP     to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide enough     support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is another mode     of providing oxygen and pressure. It is equal to nCPAP in small babies transitioning off of     ventilators, but no studies have been done in older babies. We plan to compare the feeding of     babies orally using either nCPAP with LFO2 or HHHFNC in preterm babies born before 28 weeks     gestation who are now 34 weeks corrected gestational age. The goal will be the fastest time     to full oral feeds.   "
94029|NCT02055326|"     The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a     quit-smoking program that combines behavioral therapy with either yoga, or a health &     wellness program that serves as a contact control.   "
94030|NCT02055313|"     The main objective of this study is to explore experiences and insights from exceptional     patients, patients with cancer that were considered by their physicians as having exceptional     course of survival related to their specific disease state.      A secondary future objective of this study is to develop an international multicenter     registry and database documenting and examining the experience of patients with cancer that     were considered by their physicians as having exceptional course of survival related to their     specific disease state.   "
94031|NCT02055300|"     The purpose of this study is to evaluate the safety and tolerability of escalating single     oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of     escalating single oral doses of LY03005.   "
94032|NCT02055287|"     The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following     an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the     safety and tolerability and preliminary efficacy of LY03004 following intramuscular     injection.   "
94033|NCT02055274|"     The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following     multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate the     safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of LY03003     following intramuscular injections.   "
94039|NCT02055196|"     This phase I trial studies the side effects and best dose of genetically modified stem cells     when given together with irinotecan hydrochloride in treating patients with recurrent     high-grade gliomas. Irinotecan hydrochloride may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Placing a gene that has been created in the     laboratory into neural stem cells and injecting it into the brain may help irinotecan     hydrochloride kill more tumor cells once it reaches the brain.   "
94208|NCT02052986|"     The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will     correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.   "
94034|NCT02055261|"     The appearance of postural instability and gait disorders is a major turning point in the     evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to     L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced     outside mobility. There is no effective pharmacological treatment available for these     symptoms, and their pathophysiology is not well known : it is currently assumed that     non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these     patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic     nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to     L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the     origin of these axial symptoms, since the PPN participates in the maintenance of posture and     motion in primates. In PD patients, recent reports have suggested that low frequency     stimulation of the PPN may equally improve gait and posture. However, these results are     debatable due to methodological limitations, insufficient clinical evaluation and uncertain     anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six     advanced PD patients according to the usual criteria for STN DBS who are, however, unsuitable     for this operation due to gait and posture disorders. We will perform a randomized,     double-blind and cross over design (two months periods with and without DBS randomly assigned     to each patient). The targeting will be allowed by a a three-dimensional and deformable atlas     of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (MRI) of each     patient. Evaluations will comprise 1 month before surgery and in Off and On stimulation     condition:        -  clinical motor assessment in both Off and On drug state, including cardinal          parkinsonian signs, gait and balance        -  gait initiation physiological evaluation        -  cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN          stimulation may well represent a substantial improvement of our therapeutic options for          advanced PD patients suffering from debilitating gait and posture disorders unresponsive          to L-Dopa.   "
94035|NCT02055248|"     Background:      - Moebius syndrome limits the ability to make facial expressions like smile, frown or blink -     and move the eyes laterally. It can also cause speech, swallowing or breathing difficulties     and affect parts of the body, such as the limbs, jaw, muscles, or the heart. Some individuals     with Moebius can have intellectual impairment or behavior problems. Researchers want to study     the clinical features of individuals with Moebius or related disorders and explore the     genetic and/or environmental causes of these conditions.      Objective:      - To learn more about the genetics and clinical characteristics of Moebius syndrome and other     Congenital Facial Weakness disorders.      Eligibility:      - People ages 2 to 80 years with congenital facial weakness, isolated or combined with other     congenital anomalies, and their family members.      Design:        -  Participants with Moebius syndrome or other congenital facial weakness disorder will be          evaluated at the NIH Clinical Research Center over 3 to 5 days and undergo the following          procedures:        -  Medical and family history and physical examination, including body measurements and          vital signs.        -  Blood or saliva will be collected for genetic tests and to evaluate liver, kidney, heart          and hormonal      functions.        -  Eye examination, including having a video taken of their eyes moving.        -  Hearing evaluation.        -  Speech and language assessment, including swallowing studies.        -  Dental exam.        -  Detailed neurological evaluation, including electromyogram/nerve conduction and blink          reflex study.        -  Rehabilitation medicine evaluation, including muscle and tongue strength testing and          assessment of balance.        -  Neurocognitive and behavioral testing and questionnaires to assess quality of life and          copying mechanisms.        -  Imaging studies of their head, by magnetic resonance and diffusion tensor imaging          -MRI/DTI. Participants      will lie on a table that slides into a metal cylinder that takes images of internal body     structures using      magnets. Child participants may be sedated.        -  Some adults may have additional X-rays of their head or limbs, if there are abnormal          findings.        -  Medical photographs of the face and affected body parts may be taken.        -  Other specialized tests or consultations, as indicated.        -  Participants can choose to have a skin biopsy taken.        -  A follow-up visit will be offered to participants for review of genetic test findings          and possibly additional clinical tests, as indicated.      Family members of the patients will have a medical and family history and physical     examination. Blood or saliva will be obtained for genetic studies.   "
94047|NCT02055092|"     People diagnosed with young onset dementia are today mostly assigned to the same healthcare     services as people developing dementia at an older age. They and their families are however     in a quite different life situation, which is likely to generate different challenges and     specific needs for tailored healthcare services, of importance in maintaining their perceived     quality of life.      The investigators of this study wish to assess the factors influencing these families'     quality of life, their specific needs and their use of healthcare services by the use a     combination of quantitative and qualitative methods. The main aim of this study is to provide     better future healthcare services to these families, and to develop a programme for optimal     collaboration between specialist healthcare services and the local dementia teams.   "
94506|NCT02049099|"     To describe the current treatment practice during 12 months for previously treated patients     diagnosed with haemophilia A or haemophilia B.   "
95539|NCT02035605|"     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of     ALN-AT3SC in healthy volunteers and Hemophilia A or B patients.   "
94036|NCT02055235|"     Background:      - Different people perceive the same pain differently. Mood, attention, stress, and     personality affect how we feel pain. Researchers want to know whether people who do yoga     perceive pain differently than people who do not practice yoga, meditation, or martial arts.     They also want to study if cortisol, a stress hormone, relates to pain or brain differences.      Objective:      - To study the effects of yoga on the body s stress response, pain perception, and the brain     s structure and pain response.      Eligibility:        -  Right-handed adults 30 years and older who practice yoga regularly.        -  Healthy right-handed volunteers 30 years and older who do at least mild exercise but no          yoga or martial arts.      Design:        -  Visit 1: Participants will be screened with medical history and physical exam. They will          have blood and urine tests and electrocardiogram to measure heart activity.        -  At home, participants will wear a heart monitor for 1 day and collect 5 saliva samples          daily for seven days.        -  Visit 2: Participants will undergo tests in a chair or in a mock MRI machine. They will          lie on a table that slides into a cylinder.        -  A heating device will be placed on their leg and heated periodically for few seconds at          a time.        -  They will give saliva samples.        -  Heart rate, respiration, etc. will be monitored.        -  They will fill out questionnaires.        -  Visit 3: Participants will answer questions and repeat Visit 2 tests. Tests will be done          in the real MRI machine. The scanner makes loud knocking sounds. Participants will get          earplugs. Participants will be in the scanner about 1 hour with a coil over their head.   "
94037|NCT02055222|"     Despite the implementation of modern public health interventions, 1 in 5 adults in the United     States are either current or former smokers and remain at risk for the development of chronic     lung diseases. It is unknown how or why any one individual smoker can develop a wide range of     lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The     purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar     samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles     that correspond to divergent pathways in the expression of such proteins as the transforming     growth factor-beta1 (TGF- <=1). The information generated from this study will provide     insight into the pathogenesis of smoking-related lung injury and potentially allow for the     development of early therapeutic interventions....   "
94038|NCT02055209|"     Our objective is to develop a community-based cohort and novel genomic science resource for     defining the biological significance of ancestry-related genomic variation in     African-Americans within the GENE-FORECAST :GENomics, Environmental FactORs and the Social     DEterminants of Cardiovascular Disease in African Americans STudy. This resource will enable     our team to test the working hypothesis that race-ancestry differences in the burden of     cardiovascular disease (CVD) reflects the influence of a unique interplay between the     distinct genomic variation characteristic of African-Americans (AA) and the exposome of     social determinants and environmental factors that influence the pathogenesis of CVD in AA.     The specific aims are:      AIM I. To examine the associations between common or ancestry-related DNA variants and CVD     risk factors (e.g. hypertension) and phenotypes (e.g. coronary artery calcification) in     African-Americans (AA).      AIM II. To examine the associations between health behaviors or social-environmental factors     and CVD risk factors and phenotypes in AA.      The study is designed to create a cohort amenable to nested case-control analyses based on a     community-based sampling frame with a target size of approximately 1800 self-identified, US     -born, African-American (AA) men and women (ages 21-65) to be recruited over the next 5-6     years from the metropolitan Washington DC, Montgomery County (MC) and Prince George s County     (PG) areas to be recruited to the NIH Clinical Center. The initial participant recruitment     strategy involved two approaches: 1) a random-digit telephone screening survey targeting     study-eligible AA that will be consented and invited to an evaluation visit in the NIH     Clinical Center which we contracted with a well-established survey group (Southern Research     Group [SRG]); and 2) a community outreach effort to recruit participants into the Clinical     Center by leveraging marketing and the engagement of community-based leaders, organizations     and faith-based institutions in the area. We are no longer contracting with SRG but rather     focusing on community outreach and marketing for recruitment to the Clinical Center. The     contract with SRG was terminated after the first two years of the protocol due to low yield     of recruitment to the Clinical Center compared to community outreach.      Given the high burden of CVD among AA, this approach will yield a sample with normal     individuals as well as a high proportion of AA with CVD risk factors such as obesity and     hypertension that predispose to the eventual clinical signs and symptoms of CVD (e.g. heart     attack and stroke). Based on previous epidemiology studies, this protocol s participant     ascertainment approach and the target demographic profile; it is anticipated that the     prevalence of clinically manifest CVD (history of angina, heart attack or stroke) will be     less than 10-15% of the sample. All participants will undergo extensive evaluation in the     Clinical Center that includes: medical evaluation (e.g. anthropometrics, blood pressure),     laboratory tests (e.g. lipid levels, kidney function), social determinants profiles (e.g.     socioeconomic status (SES), perceived stress, discrimination, depression, perceived     neighborhood characteristics), blood/urine collection for deep-sequencing based omic analyses     (e.g. whole exome sequencing, and RNA-Seq), as well as testing for pre-clinical , biomarkers     of the pathobiological processes of CVD or CVD phenotypes (e.g. coronary artery     calcification, microalbuminuria, leukocyte telomeres, or vascular dysfunction). It is     anticipated that these deep sequencing efforts will yield novel ancestry-related DNA variants     associated with the CVD phenotypes; yet with unclear biological significance in elucidating     racial disparities in CVD. Accordingly, our protocol also includes a Genotype-to-Phenotype     (G2P) component that re- contacts subsets of the cohort based on their genotype (e.g. APOL1     chronic kidney disease risk alleles) for a call-back visit for more in-depth phenotyping and     characterization of the potential effect of the DNA variant of interest on human systems     biology. In some cases family members of the proband may also be invited to participate in     these G2P studies to further characterize the biological significance of these putative     functional DNA variants of interest.      The primary outcome variables involve well established CVD phenotypes: 1) CVD risk factors     (e.g. hypertension, dyslipidemia), 2) markers of pre-clinical CVD (i.e. coronary artery     calcification, coronary plaque burden by cardiac CT angiography (CTA), carotid plaque burden     by 3D ultrasound, vascular dysfunction, microalbuminuria, C-reactive protein, Vitamin D     levels). The protocol will assess exposures associated with CVD and relevant covariates     including: 1) social determinants (e.g. socioeconomic status (SES), perceived stress,     discrimination, and depression); 2) environmental factors s......   "
94074|NCT02054728|"     The purpose of this study is to assess hemodynamic effects of inspiratory muscle training     during routinely performed right-heart catheterization.   "
94040|NCT02055183|"     The purpose of the Registry will be to evaluate patient safety following Botulism Antitoxin     Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric     patients with a confirmed or suspected exposure to botulinum toxin. This Registry is intended     to serve as an active surveillance system to further assess the safety profile for BAT® and     to quantify the occurrence of unexpected adverse events, given that the current safety     database is considered too small to reliably identify unexpected risks.   "
94041|NCT02055170|"     The purpose of this study is to study the effect of hormone therapies (androgen pathway     modification) on the outcomes of patients with lung cancer. This information may be of     benefit for future treatment strategies, prevention and control.      In this study, the protein where testosterone binds, called the androgen receptor (AR), will     be measured in samples from the patient's biopsy and surgical tumor samples. The     investigators will look at a marker of how fast the cancer is growing (Ki67) before using     finasteride from your biopsy specimen. Finasteride will be taken from the day of consent     until the day of the patient's surgery. This marker will be measured again after using     finasteride from the surgical specimen. The investigators will be looking for a decrease in     the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that     this medication is blocking tumour growth.   "
94042|NCT02055157|"     This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in children     with achondroplasia. The primary objective is to assess the safety and tolerability of daily     BMN 111 administered to children with achondroplasia.   "
94043|NCT02055144|"     VeriStrat® is a pretreatment blood-based test correlated with clinical outcome after EGFR-TKI     therapy in non-small cell lung cancer (NSCLC) patients.      The investigators hypothesis is that VeriStrat could be also employed as a biomarker of     benefit from treatment with standard chemotherapy regimens in first line NSCLC patients.   "
94044|NCT02055131|"     This is a prospective study consisting in testing whether systematic use of aspirin is     beneficial for primary prevention of vascular access for hemodialysis attested by doppler     ultrasound exam. The investigators will study aspirin resistance in the population of     patients undergoing hemodialysis. The investigators will test sensibility of resistant     patients to aspirin dose escalation. PFA-100 is the biologic test used in this study to     define aspirin resistance.   "
94045|NCT02055118|"     Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical     parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg     for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have     previously received and tolerated a minimum of 4 months of therapy with Elaprase.   "
94046|NCT02055105|"     The goal of this study is to demonstrate the sensitivity and specificity of detecting     circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow     expression and modulation of levels in response to therapy in comparison to current     biomarkers.   "
94068|NCT02054806|"     This study will assess the efficacy and safety of pembrolizumab (MK-3475) administered to     participants with incurable advanced biomarker-positive solid tumors that have not responded     to current therapy or for which current therapy is not appropriate.      The study hypothesis is that administration of pembrolizumab to participants with some types     of solid tumors will result in a clinically meaningful response rate.   "
95749|NCT02032849|"     This is a randomized controlled trial compared two methods to drainage subglottic secretion     in prolonged intubated patients.After enrolled, patients are randomized assigned to     intermittent subglottic secretion drainage group and air-impingement manipulation group.   "
94048|NCT02055079|"     Sirolimus (SIR) has lead to a reduction of overall kidney size, a decrease in cyst density     and general tubular cell proliferation in animal models, and to a reduction of the increase     in creatinine and blood urea nitrogen by 34 and 39 percent respectively, as well as a     reduction of cyst proliferation, expressed by a 30 percent reduction of overall kidney     enlargement, a reduction in general cyst volume, and a reduction of the cyst volume density     in the renal cortex in humans.      However, despite promising data from animal- and in vivo studies, most mammalian target of     rapamycin inhibitor (mTOR-I) studies in patients with autosomal-dominant polycystic kidney     disease (ADPKD) produced only subtle if any clinically relevant effects on cyst growth and     the preservation of renal function.      In this study we will investigate if pulsed administration of SIR in a fixed weekly oral dose     of 3 mg over 24 months compared to placebo significantly reduces cyst growth and preserves     excretory renal function in patients with ADPKD and an estimated glomerular filtration (eGFR)     rate below 60 mL/min per 1.73m2.   "
94049|NCT02055066|"     This a first-in-human study of an antibody blocking the function of the oncogene c-met in     patients with cancer.   "
94050|NCT02055053|"     To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia     repair on post-operative pain.   "
94051|NCT02055027|"     Prospective study designed to identify factors that would predict patient adherence to CPAP     (Continuous Positive Airway Pressure) therapy.   "
94052|NCT02055014|"     New effective non-surgical treatments are needed for patients whose obesity and type 2     diabetes (T2DM) do not respond to current medical therapies. We propose a randomised     controlled trial of Endobarrier, an implantable intestinal device that separates ingested     food from contacting the first 60cm of intestine where sited and that mimics some of the     clinical effects of bariatric surgery (improved metabolic control with weight loss) with or     without continued use of the GLP-1 receptor agonist (GLP-1RA) Liraglutide 1.2mg vs     Liraglutide 1.8mg without the device in obese patients with T2DM who remain with suboptimal     glycaemic control despite current conventional diabetes treatment, in an NHS setting.      Seventy-two patients with T2DM and obesity (HbA1c≥7.5%, BMI≥35kg/m2) despite previous GLP-1RA     therapy will be studied over 24 months and randomised to receive Endobarrier with continued     Liraglutide 1.2mg for 12 months; Endobarrier alone for 12 months; or Liraglutide 1.8mg     without Endobarrier.      We will investigate potential mechanisms of action and their time course as part of the study     by repeated measures of: 1. insulin resistance measures, gut peptides, bile acids; 2. energy     intake and nutritional composition; 3. liver fat stores, 4. intestinal inflammation and     permeability measures.      The data will inform clinical use of the device and development of new treatments for T2DM     and obesity.   "
94053|NCT02055001|"     Atherothrombotic disorders account for 25% of all deaths among women and for substantial     morbidity and resource use in health care. Nonetheless, gender-related differences in the     epidemiology of cardiovascular disease (CVD) remain largely unexplained. Among mechanisms     that could account for such differences, the biology of platelets, which exert a pivotal     pathogenetic role in atherothrombosis, and of coagulation system are on investigation.      Thus, differences in platelet reactivity between women and men have been described using     several methods and in response to varying stimuli. Indeed, sex steroid hormones could be     involved in a different response of platelet to physiological response to agonists. The     finding that estrogen receptors are expressed in platelets makes these cells an excellent     model for studying the non-genomic effects of steroid hormones. Also coagulation cascade has     been reported to be influenced by sexual endogenous as well as exogeneous hormones (i.e     contraceptives) In particular, the impact of endogenous estrogens (menstrual cycle) on     platelet activity and on response to antiplatelets drugs in fertile women has never been     evaluated.      Accordingly, the goal of this proposal is to investigate relationship between platelet     function (assessed by aggregometry tests and markers of platelet activation in vivo such as     thromboxane production, CD40L and P- selectin levels) and sex hormones during physiological     regular menstrual cycles (28-30 days) in healthy pre-menopausal women aged from 18 to 40     years. Moreover, in a subgroup of healthy women free from antiplatelet drugs, will be planned     a proof of concept study to investigate if there will be variations, during a short term (1     month) low dose aspirin, in platelet reactivity according to the different phases of     menstrual cycle in 10 healthy premenopausal women aged from 18 to 40 years. Moreover, it will     be investigate effect of steroid hormonal pattern on residual platelet activity response on     treatment   "
94054|NCT02054988|"     Prasugrel is a potent thienopyridine antiplatelet agent that selectively and irreversibly     inhibits ADP-induced platelet aggregation mediated by the P2Y12 receptor. Prasugrel is a     prodrug that must first undergo biotransformation to its active metabolite via cytochrome     P450-mediated hepatic metabolism (CYP1A2). Clopidogrel is currently administered to several     million patients especially after coronary stenting. Clopidogrel has been shown to reduce     cardiovascular complications in patients with acute coronary syndromes and patients who have     undergone coronary stenting. The mechanism of action of clopidogrel's active metabolite     involves inhibition of the purinergic adenosine diphosphate (ADP) receptor P2Y12 on the     platelet membrane. Blockade of this receptor prevents uncoupling of the associated Gi2     protein which ultimately leads to increased platelet cyclic AMP (cAMP) formation.3 Cyclic AMP     is a key signaling molecule in inhibiting platelet aggregation, but its intracellular levels     are affected by several other commonly used compounds. For instance, methylxanthines, such as     caffeine, theophylline, and theobromine (an ingredient of chocolate), all cause elevation of     intracellular cAMP levels by inhibiting adenosine receptors (types A1 and A2) on the platelet     membrane. The effect of caffeine consumption on platelet reactivity depends on the caffeine     dose and duration of administration. Chronic caffeine consumption (≥7 days) appears to be     associated with inhibition of platelet aggregation, probably through upregulation of     adenosine receptors.The aim of this study was to examine the effect of acute caffeine     consumption, at a dose equivalent to commercial coffee drinks, on the antiplatelet effect of     clopidogrel and prasugrel, in patients with coronary artery disease (CAD).      Platelet function will be evaluated using a validated method: the VerifyNow System     (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical     detection system that measures platelet-induced aggregation.   "
94055|NCT02054975|"     This is a pilot randomized controlled trial of lower vs. higher dose vitamin D     supplementation in D-deficient asthmatic children, to determine necessary sample sizes for     outcome measures in a larger multisite study, and to examine possible relationships and     effect sizes between various biological markers that may be important to the pathophysiology     of childhood asthma.      Aims of the study are to:        1. Evaluate effect sizes for relationships between serum 25OH-vitD and omega-fatty acid          (FA) biomarkers, before and after supplementation with lower or higher dose vitamin D,          on immune function, and asthma severity.        2. Characterize changes in innate and adaptive immune function and inflammatory responses          in asthmatic D-deficient youth at baseline and after vitD supplements, by dietary          O6:O3FA status and vitD dose.   "
94081|NCT02054637|"     Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK)     secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing     almost completely bile salts output from the gallbladder. Somatostatine is also known to     decrease acid production with significant increase of intragastric pH. In this way,     somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder     emptying and decreasing acid secretion.      Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and     endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that     cannot be controlled with classic therapy.   "
94056|NCT02054962|"     Chronic problems after traumatic events are common in non-elderly adults. Previous studies     have shown that after minor motor vehicle collision (MVC), 10-30% of non-elderly adult     patients develop chronic regional pain (neck or back pain). In addition, up to 1/3 of     non-elderly adults will develop psychological sequelae, including posttraumatic stress     disorder, depression, and anxiety disorders. There have been no prospective studies examining     the frequency or predictors of persistent pain or psychological sequelae in older adults. The     proposed study seeks to determine the frequency of persistent pain, psychological sequelae,     and associated disability in older adults after minor MVC trauma and to identify candidate     predictors for a model of adverse outcomes after MVC in this population. 200 individuals over     65 years of age will be recruited from emergency departments in four states with no-fault     accident laws. Patients who meet inclusion criteria and who consent to the ED study will     undergo a 30-45 minute ED assessment of crash-related, psychosocial, and biological factors,     and complete telephone follow-ups at 2 weeks, 6 weeks 6 months, and 12 months. The wealth of     information gained from this study will be used to determine the frequency of adverse events     in older adults after MVC and to identify high risk elderly patients. These results will     inform subsequent development of secondary pharmacologic and/or behavioral interventions to     prevent chronic pain and psychological sequelae after traumatic events in older adults.   "
94057|NCT02054949|"     This is a study to find out whether the dietary amino acid supplement, N-acetyl cysteine     (NAC) is helpful in reducing the frequency of seizures in children with autism and comorbid     epilepsy whose seizures are not responding well to usual medical treatment. The study is also     looking to see if this supplement is helpful for immediate and ongoing treatment of symptoms     of irritability. Additionally, this study will also look to see if certain substances in the     blood that measure a specific type of stress on cells in the body can help tell us how NAC     may be helping.   "
94058|NCT02054936|"     To compare side effects and complications relating to use of warfarin or rivaroxaban,     tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively,     extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub and     supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two     randomized groups. Return visits to the operating room, length of stay, and VTE rates will     also be compared.   "
94094|NCT02054468|"     This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required     for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant     rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting.   "
94059|NCT02054923|"     Routine video recording of the colonoscopy examination has been proposed as a simple and easy     to implement method that could improve the quality of colonoscopy. The purpose of this study     is to investigate whether implementation of routine video recording of screening colonoscopy     withdrawal is effective as a means of supporting quality performance of colonoscopy. The     study will be performed in 8 screening centers within the framework of a national colonoscopy     screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP). Individuals     aged 55-64 years are eligible to participate in the PCSP. In the run-in period colonoscopy     quality measures will be monitored through a dedicated joint database. Then eligible     screening centres will be randomly assigned in a 1:1 ratio to the video recording group or     the control group. Screening centres assigned to the video recording group will receive     videorecorders and DVDs and will be asked to video record all screening colonoscopies (only     withdrawal). Control group will be allowed to record colonoscopies on demand only. Then , the     colonoscopy quality measures will again be monitored through a dedicated joint database. All     the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the     PCSP team.   "
94060|NCT02054910|"     This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus     Block (CPB) treatment in comparison to EUS without a pain block administered. All     participants will receive medications for pain as needed.   "
94061|NCT02054897|"     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety     of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes.     (SUSTAIN™ 1-Monotherapy).   "
94062|NCT02054884|"     There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have     been conducted to establish standard of care. Despite a sizable number of objective responses     induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival     has never been demonstrated.      This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in     combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic     efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are     not amenable to surgery.      A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the     study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A),     and 45 patients will receive paclitaxel monotherapy (Arm B).   "
94063|NCT02054871|"     This study aims to demonstrate if remote ischaemic preconditioning (RIPC) may confer renal     protection in patients undergoing peripheral angioplasty. Patients will be randomised to     receive RIPC and biomarkers for renal injury will be analysed post procedure to determine if     any protective benefit was obtained.   "
94064|NCT02054858|"     This study aims to assess if applying an ischaemic insult to an arm before giving intravenous     contrast will help decrease the incidence of developing contrast induced acute renal injury     in patients undergoing contrast-enhanced CT Scans.      The main research question is 'In adult in-patients undergoing contrast-enhanced CT scans,     does remote ischaemic pre-conditioning (RIPC) induced by brief arm ischaemia and reperfusion,     when compared to control, reduce the proportion of patients developing contrast-induced acute     kidney injury in the first 3 post-scan days? '.   "
94065|NCT02054845|"     Approximately 60% of the patients with Parkinson's Disease (PD) that receive Levodopa therapy     eventually develop response fluctuations in motor symptoms, such as rigidity, freezing and     akinesia. Patients experience an 'off'-period just before the next dose of dopaminergic     medication is needed, called the 'wearing-off'-phenomena. Wearing-off is also accompanied by     non-motor symptoms such as depression, anxiety, pain and thinking disability. Together, these     motor and non-motor symptoms have a major impact on the quality of life of patients and their     partner or caregiver.      Patients with wearing-off often experience severe anxiety and panic symptoms that are     incongruent with the severity of the motor symptoms during an 'off' period. These symptoms     include stress, dizziness, pounding/racing of the heart, dyspnoea and hyperventilation. This     type of anxiety is called wearing-off related anxiety (WRA) and might be a consequence of the     hypersensitivity towards somatic manifestations and effects of a wearing-off period. This     bodily misperception can have major consequences for the patient's feelings and behaviour.     The experienced anxiety is often not consciously linked to the wearing-off and is therefore     not well recognized by neurologists.      Treatment as usual in response fluctuations is physiotherapy, consisting of physical     exercises for mobility problems, freezing, dyskinesias, etc. This kind of training hardly     touches upon the mental aspects and the role of anxiety as integral element of the response     fluctuations. Cognitive behaviour therapy (CBT, including exposure in vivo) is sometimes used     to treat WRA, but seems to have unsatisfactory results since the changed body awareness is     not sufficiently addressed. Also, the methods used in cognitive therapies focus on the     elimination of WRA which is often not realistic since wearing-off symptoms will remain or     even increase during disease progression. As of yet, there are no known alternative     intervention options. This study focuses on a new intervention by integrating elements from     physiotherapy, mindfulness, CBT (mainly exposure), Acceptance and Commitment Therapy (ACT)     and psycho-education.      Objective: The current proposal aims at investigating the effect of a multidisciplinary     non-verbal intervention on the awareness and modulation of WRA to improve self-efficacy,     mobility, mood, and quality of life as compared to usual care.      Study design: Randomized controlled clinical trial.      Study population: Thirty-six PD patients who experience WRA.      Intervention: Patients with PD are randomly allocated into one of two groups (n= 18 each).     One group receives the experimental 'body-awareness therapy', while the second group receives     regular group-physiotherapy (treatment as usual). Both interventions will take 6 weeks in     which 2 sessions per week with a duration of 1,5 hour will be performed.      Main study parameters/endpoints: The General Self-Efficacy Scale is the primary outcome     measure and will be assessed prior to, directly after and 18 weeks after the intervention.   "
94066|NCT02054832|"     The aim of the present study is to determine if there is a change in quality and quantity of     sleep perceived by adults and children with GSD and their parents while starting a modified     UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate if     there is a change in quality of life perceived by adults and children and their parents with     Glycosade.   "
94067|NCT02054819|"     It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease     can benefit from curative therapy and extends beyond the very limited subset of     oligometastatic patients that have already been studied.   "
94110|NCT02054260|"     The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed     bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding   "
94069|NCT02054793|"     This research is being done to test the safety and anti-cancer activity of the combination of     an investigational drug called orteronel, with a drug called itraconazole in the treatment of     castration-resistant prostate cancer.      Orteronel is an investigational drug known as a 17,20-lyase enzyme inhibitor, meaning that it     blocks the formation of male sex hormones.      Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of     various fungal infections such as fingernail/toenail infections and other more serious fungal     infections. While it has shown evidence of activity against prostate cancer in prior studies,     it is not approved for use in cancer. The FDA is allowing the use of orteronel and     itraconazole in this research study. In addition to its antifungal properties, itraconazole     was discovered to function to block angiogenesis (blood vessel formation to tumors) to block     a cellular pathway thought to be important in prostate cancer known as the Hedgehog pathway.      Investigators hypothesize that blocking male sex hormone production with orteronel will     increase reliance on the Hedgehog pathway in prostate cancer cells which can then be blocked     with itraconazole and that the combination of these two drugs will be more effective than     either alone.   "
94070|NCT02054780|"     The purpose of this study is to compare the effectiveness of two types of counseling,     Psychosocial Counseling (PC) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), in     addressing outcomes of orphans and vulnerable children (OVC) including mental and behavioral     health, well-being, social support, and HIV risk behaviors. The study will be conducted in     Lusaka, Zambia.   "
94071|NCT02054767|"     The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and     mepivacaine in patients with irreversible pulpitis of mandibular molar.   "
94072|NCT02054754|"     The purpose of this study is to test the safety and observe the pharmacokinetics     (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy     male subjects following a single oral dose.   "
94073|NCT02054741|"     This cluster randomized clinical trial compares a geriatric assessment intervention with     usual care for reducing cancer treatment toxicity in older patients with cancer that has     spread to other places in the body. A geriatric assessment may identify risk factors for     cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.   "
94075|NCT02054715|"     This randomized clinical trial compares multimedia psychoeducation to print education in     preparing patients with cancer for decision making about clinical trial participation.     Multimedia psychoeducation includes a DVD and written materials with a combined focus on     knowledge and attitude change, and may be an effective method to help patients prepare for     decision making about clinical trial participation. It is not yet known whether a multimedia     psychoeducation is more effective than print education in preparing patients for decision     making about clinical trials.   "
94076|NCT02054702|"     The purpose of this study is to explore changes in efficacy, cognitive functioning, and     safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia   "
94077|NCT02054689|"     This is a research trial that seeks to break up the total radiation dose into multiple     smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may     make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and     possible costs will be described later in this document. This clinical trial is for people     who have had no prior whole brain radiation.   "
94078|NCT02054676|"     The purpose of this study is to evaluate validation and clinical assessment of the earlier     proposed clinical and radiological classification of the jawbone anatomy in endosseous dental     implant treatment.      Expected results.        -  high accuracy of proposed classification for proper implantation risk degree evaluation.        -  the proposed classification system based on anatomical and radiological jawbone quantity          and quality evaluation will be a helpful tool for planning of treatment strategy and          collaboration among specialists.        -  good interobserver reliability of clinical and radiological edentulous jaw segment          evaluation.        -  good reliability between radiological and intraoperative investigations and          postoperative data.   "
94079|NCT02054663|"     After a heart attack patients are routinely started on drugs to inhibit platelets. Ticagrelor     is a powerful anti-platelet drug with clinical benefits. However it must be discontinued in     some, because of increased risk of bleeding or intolerance. These patients need to be     transitioned to another agent, such as Clopidogrel. At present, there is no clinical     consensus on the optimal strategy for this switch. Some clinicians elect to give a bolus dose     of clopidogrel with 600mg, while others start directly with a 75mg daily dose, with no     evidence regarding the benefits or potential complications associated with each strategy. The     present proposal will evaluate the pharmacodynamics of 2 strategies with specialized platelet     function testing. We hypothesize that a bolus dose of clopidogrel during the switch will     confer better ischemic protection without increasing bleeding risk for patients undergoing a     switch in therapy.   "
94080|NCT02054650|"     The study hypothesis is based on osteopathic medical philosophy that: 1) the body is a unit;     2) the body has inherent self-regulatory mechanisms; 3) structure and function are     interrelated; and 4) rational treatment is based on an understanding and integration of these     concepts. Patients with type 2 diabetes mellitus often report more aches and pains than     people without diabetes. Because osteopathic manual medicine addresses dysfunction in the     musculoskeletal system, patients with both chronic low back pain and type 2 diabetes mellitus     may benefit from this non-pharmacological treatment to reduce their pain, thereby reducing     their stress and perhaps providing better clinical control for diabetes as demonstrated by     key markers such as hemoglobin A1c and kidney function. This study is an extension of     research completed in the OSTEOPATHIC Trial. Results of that study were published in the     Annals of Family Medicine in March/April 2013.   "
94111|NCT02054247|"     The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous     ultrasound treatments combined with splint therapy on patients with mild and moderate     idiopathic carpal tunnel syndrome   "
94112|NCT02054234|"     The objectives of this study is to assess the characteristics and frequency of adenovirus     conjunctivitis in a population of male and female patients from one year of age who present     signs and symptoms of acute conjunctivitis.   "
94082|NCT02054624|"     The purpose of this research study is to learn about ways to help overweight adults from     rural areas manage their weight and increase their physical activity. An important goal of     the study is to find out what type of follow-up program for weight management is necessary to     help overweight and obese people keep from regaining lost weight. The study will also look at     the ways that long-term weight-loss treatments affect blood pressure, blood fats (lipids),     blood sugar, and physical fitness.      You are being asked to be in this research study because increased weight and obesity are     major health problems in the United States. You have been identified as being overweight or     obese. People who are obese have an increased risk of developing health problems such as high     blood pressure, diabetes, and heart disease. The rates of being overweight and obese are     higher in rural areas of the United States than in urban and suburban areas of the country.   "
94083|NCT02054611|"     Without rigorous, high-quality training materials, the results of the LUNG-SAFE study     examining the global incidence and outcomes of severe lung failure (acute respiratory     distress syndrome [ARDS]) could be confused by either under-recognition of patients with, or     misclassification of patients without, ARDS. This problem has been previously identified with     the use of the prior ARDS definitions, particularly in patients with milder severity of     illness. Importantly, the chest x-ray criteria in the ARDS definition has demonstrated only     moderate reliability when applied by experts, although this can be improved through the use     of training radiographs (as will be used in this educational module). The investigators     hypothesize that the training from the educational module will allow more accurate diagnosis     of ARDS by data collectors/study coordinators participating in the LUNG-SAFE study.   "
94084|NCT02054598|"     This study is a multi-site randomized, controlled trial testing the effect of a combined     intervention that includes a colorectal cancer (CRC) screening decision aid plus patient     navigation in a diverse, primary care patient population in clinical sites in North Carolina     and New Mexico.      Our primary aim is to determine the effect of the intervention on CRC screening completion     six months after the index visit among all enrolled participants and among Latinos.     Secondarily, we will determine how this intervention affects screening-related knowledge,     self-efficacy, intent, and clinical communication, and examine whether these factors mediate     the effect of the intervention on screening test completion. Lastly, we will explore whether     insurance status, ethnicity, and patient language preference moderate the effect of the     intervention on screening.   "
94085|NCT02054585|"     Dehydration and refusal to eat and drink are common complaints in the Pediatric ED (Emergency     Department). Most of these children have had an unsuccessful trial of oral rehydration in     their community service, therefore are treated with IV rehydration. There is no consensus as     to which IV solution is the best one for rehydration. Children who are unwilling or unable to     eat and drink produce Keto bodies. Theoretically, addition of glucose to the IV solution     would prevent catabolic metabolism and reduce the keto bodies blood concentration which     should lead to a faster objective and subjective improvement of the child's condition.      The proposed study is a double blind randomized clinical trial. Children will receive either     NaCl 0.9% or NaCl 0.9% + 5% glucose randomly in numbered bags. The type of solution will be     known to the pharmacy only.      Study aims:        -  Primary aim: to compare the number of hospitalizations among dehydrated pediatric          patients treated with either one of the IV fluids mentioned above.        -  Secondary aim: To evaluate for the possibility of hypoglycemia secondary to          hyperinsulinism as a response to a rapid administration of glucose.      Study population: The study will include 700 children 6 month to 18 years of age. It will be     conducted over 18 months in the Pediatric ED of Carmel Medical Center.      Currently, data regarding the use of dextrose containing solutions is lacking. As dehydration     is one of the most common medical problems encountered by the physician in the pediatric ED,     it is of outmost importance to evaluate the optimal IV solution used in this setting.   "
94086|NCT02054572|"     The primary objectives of this study were to determine the rate, extent, and routes of     radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to     measure radioactivity concentrations in whole blood and plasma over time.   "
94087|NCT02054559|"     To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the     treatment of localized CD20 (+) diffuse large B-cell lymphoma   "
94088|NCT02054546|"     The purpose of this study is to analyze the new biomarkers (TIMP-2 and IGFBP-7) of tubular     renal cell damage for the prediction of the Cardiac Surgery Associated acute kidney injury.   "
94089|NCT02054533|"     Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last     ten years. Evidence now suggests that the most effective therapy early in the course of     Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing     medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab,     and certolizumab. However, many CD and UC patients still ultimately require surgery despite     the use of these medications. Side effects of the anti-TNF agents include increased risk of     infections due to their effect on the immune system. Little is known about how use of these     medications near the time of surgery may affect patients' risks of infection or other     post-operative complications. The only available studies on this topic have given conflicting     results. These studies have been limited by the fact that they have been small in size and     retrospective. Retrospective studies primarily involve chart review as the method of     identifying potential risk factors for infections and other complications after they have     already occurred. This method limits both the type and quality of information/data that can     be collected. The conflicting results have led to variance in practice patterns with regards     to management of anti-TNF agents, the timing of surgery, and even the types of surgery.      By enrolling patients at the time of their surgery, collecting extensive information may be     possible than previously studied on potential risk factors for both infectious and     non-infectious complications following surgery. Risk factors to be studied will include     individual patient characteristics, disease characteristics, surgical methods, novel     characteristics of CT scans and MRIs and extensive medication exposures. The primary     objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk     of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient     history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of     drug levels at the time of surgery has never been utilized in this way to evaluate the risk     of anti-TNF agents in IBD. However, this has been done to assess the risk of other     medications in different diseases.      If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD     patients undergoing surgery, change maybe needed in the way these medications are used around     the time of surgery. Additionally, by collecting comprehensive information on other potential     risk factors besides medication use patients at greatest risk for bad outcomes can be     identified and take protective measures when possible. The aims of this study address the     CCFA challenge to better define the risks of medical and surgical therapies to improve the     quality of care of IBD patients undergoing surgery.   "
94090|NCT02054520|"     The purpose of this study is to examine the effectiveness of immune checkpoint inhibitors     (drugs called ipilimumab, nivolumab, or pembrolizumab), either given alone, or in combination     with the experimental immunotherapy drug, dorgenmeltucel-L, for melanoma. We hypothesize that     this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage,     significant prolongation of progression-free, disease-free or overall survival compared to     the use of immune checkpoint inhibitors alone.   "
94091|NCT02054507|"     The main purpose of this study is to better evaluate prematurely born children cognitive     development at school age, with regards to birth conditions but also to social situation,     intra family relationships, and modalities of care.      The study will be divided into 3 parts:        1. Children born prematurely in our level III referral Center will undergo psychometric          evaluation at 8 to 11 years of age by routine cognitive test. The relationships between          cognitive scores and neonatal characteristics will be determined and compared to the          results of schoolmates born at term.        2. The quality of parent and child relationship will be evaluated by a standardized          questionnaire allowing the evaluation of persistent stress trauma related to premature          birth.        3. An anthropologic study of the utilization of care resources will also be performed          within the follow-up network taking care of these children.   "
94092|NCT02054494|"     HIV-infection is associated with an increased risk for cardiovascular disease. Especially     patients with low CD4+ counts have a higher incidence of structural heart disease. Myocardial     T1 relaxation time, as well as T1-derived extracellular volume fraction are relatively new     methods for non-invasive myocardial tissue characterization, including diffuse myocardial     fibrosis.      In our study HIV-patients with high and low CD4+ counts are examined on a 3T MRI scanner     (Ingenia 3T, Philips Medical, Best, Netherlands). Scanning protocol includes common SSFP     sequences, STIR imaging and LGE [Late gadolinium enhancement]. All HIV patients are treated     in the HIV outpatient clinic of the hospital's Internal Medicine department and have an     unremarkable history of cardiac disease. Patients are recruited from all over Germany. In     order to obtain reference values, a subgroup of healthy, age-matched controls is included in     this study.      Aim of this study is to show differences in T1- and ECV-values in the investigated subgroups.     In addition, we also want to create cut-off values for healthy and affected myocardium in     asymptomatic HIV-infected patients. This study could show whether myocardial T1 mapping is a     potential screening parameter for beginning heart disease as part of an HIV-infection, and     whether an application in routine diagnostic is reasonable.   "
94093|NCT02054481|"     The overall purpose of this trial is to assess clinical efficacy and safety of different     subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to     select doses for further clinical trials.   "
98645|NCT01994980|"     Hypothesis: 4 days of antibiotic therapy, as compared to 8 days, is equally effective and     results in decreased antibiotic exposure among surgical ICU patients with early VAP.   "
94097|NCT02054429|"     The purpose of this study is to determine the safety and efficacy of lowering glucose (blood     sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will     determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve     90-day functional and neurological outcomes in comparison to standard glycemic care in     patients with acute ischemic stroke. The study will involve treatment of 100 (50 intensive     insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8     hours of acute ischemic stroke who have undergone endovascular therapy.   "
94098|NCT02054416|"     In this clinical research study the investigators will test the efficacy of an innovative,     non-invasive methodology to reduce mortality and lower limb loss among high-risk     medically-underserved patients with cardiovascular disease in North Philadelphia.      Patients with cardiovascular disease and recent lower limb amputation will be treated with an     intermittent compression device on the remaining lower limb to prevent dual amputation.      The study hypothesis is that the study intervention will protect against further lower     limb-loss/death and reduce cardiovascular mortality in these patients (one year effect     against limb-loss/death).      This study may result in better secondary prevention strategies for disadvantaged urban     populations as well as the general population.   "
94099|NCT02054403|"     Rationale: Primary angle closure glaucoma (PACG) causes high rates of blindness, either by     means of a painful attack of acute angle closure glaucoma or unnoticed over a period of many     years. Patients with angle closure are particularly at risk but can be detected during an     ophthalmological examination and sent for early preventive (laser) intervention. Current     practice shows that patients at risk of PACG are frequently missed during routine     examinations. Moreover, new imaging techniques like swept source optical coherence tomography     (SS-OCT), are emerging with which the angle of the anterior chamber can be imaged in great     detail with no burden for the patient. These techniques are already used in clinical practice     and replace and complete part of the ophthalmic examination. However, in Caucasians, it is     not yet known to what extent angle closure is detected in regular care and can be detected     with this OCT device. There are few published data concerning angle closure and PACG in     Caucasians and its characteristics.      Objective: To quantify the presence of angle closure by gonioscopy in patients at risk of     angle closure on SS-OCT. Secondary objectives are to quantify the presence of an increased     intra-ocular pressure during the day or after dark provocation, to quantify morphometric     details of the anterior chamber, structural changes, and corneal endothelial cells and to     quantify the functional changes of the visual field.      Study design: prospective, observational, descriptive study. Study population: Caucasian     patients, presenting at the outpatient clinic of the University Eye Clinic Maastricht, aged     40 to 80 years, who are diagnosed with angle closure on SS-OCT.      Intervention (if applicable): Not applicable. Main study parameters/endpoints: The main study     parameter is assessment of the anterior chamber angle according to gonioscopy. Secondary     study parameters are the presence of an increased intra-ocular pressure (IOP) (>21 mmHg)     during the day or after dark provocation (IOP rise from baseline), morphometric details of     the anterior chamber, structural changes of the retinal nerve fiber layer, number of corneal     endothelial cells and functional changes of the visual field Hypothesis: It is hypothesised     that, based on its resolution and ease of use, SS-OCT is a suitable imaging technique to     identify patients with or at risk of angle closure. It will be of value as an additional     diagnostic instrument and may even replace gonioscopy.   "
94100|NCT02054390|"     Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the     present cohort study is to investigate whether ACEi therapy reduces the rate of     periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention     (PCI) among patients with metabolic syndrome.   "
94113|NCT02054221|"     Compare the results of reconstruction and mitral valve replacement in the surgical treatment     of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.   "
95750|NCT02032836|"     Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb   "
94101|NCT02054377|"     Cystic fibrosis (CF) is a progressive disease. Symptoms include coughing, poor lung     ventilation, recurrent infections, poor weight gain, diarrhoea, malnutrition, stress,     frustration, depression, irritability, worry, insomnia, behavioural issues and missed     school/work.      Tai chi, a Chinese form of exercise, uses slow choreographed movements, breathing exercises     and mindfulness. Research suggests tai chi can improve physical and emotional wellbeing for     various chronic conditions.      This study compares methods of teaching tai chi to 70 people with CF, and evaluates the     effect on symptoms and quality of life. Adults and children with CF will be recruited and     randomly allocated to an intervention group or a control group. The former will receive 8     individual face to face sessions of tai chi over a 3 month period and a video and handouts to     aid home practice. The latter will have routine care for the first 12 weeks, followed by 8     individual online sessions of tai chi over a 3 month period, and a video and handouts for     home practice.      Both groups will be encouraged to practice tai chi at home in the months following the taught     sessions.      Questionnaire data on how participants and their carers are coping with CF, any general     improvements in wellbeing, and differences in other clinical outcomes (medication etc.)will     be collected. Data will be collected at the beginning and end of the intervention, and at 6     and 9 months post intervention and differences between the 2 groups compared over time.      Feedback from on line focus groups will ask about their experiences, feasibility of learning     and practicing of tai chi, engagement with the process, perceived health impact, and     experiences of participation.      It is hoped that the study may show how Tai Chi can help people with CF to maintain their     health through mindful exercise, and improve troublesome symptoms like sleep and anxiety.   "
94102|NCT02054364|"     This study aims to investigate the feasibility of combining Cognitive Remediation Therapy     (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to     reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be     randomly assigned to one of two groups: one group will receive FBT and CRT, and the other     group will receive FBT and art therapy.   "
94103|NCT02054351|"     Advanced ovarian cancer is a high medical need indication. Cure is not available to these     patients and treatment has palliative intent. A proportion of advanced stage ovarian cancer     expresses substantial levels of Claudin 6 (CLDN6), a carcino-embryonic transmembrane protein,     which is absent from normal adult human tissue. IMAB027 is a monoclonal antibody that binds     to CLDN6. Preclinically IMAB027 was shown to inhibit tumor growth and to kill cancer cells by     antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This trial is     a first-in-human dose escalation and dose finding Phase 1 trial of IMAB027 in patients with     recurrent advanced ovarian cancer to assess the safety and tolerability, the     pharmacokinetics, the antitumoral activity and the immunogenicity of IMAB027.   "
94104|NCT02054338|"     The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to     paclitaxel and gemcitabine is based on the following points: the significant antitumour     activity of vinflunine in metastatic breast cancer (MBC) as single agent after     anthracycline-taxane exposure and recent phase I study results of the vinflunine plus     gemcitabine is at least additive and both drugs have a distinct mechanism of action; since     taxanes have been approved in the adjuvant setting and are widely used in the treatment of     early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first     line therapy for metastatic breast cancer.   "
94105|NCT02054325|"     It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%     hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included only     adult women with reticular veins on the side of the thighs and mild venous insufficiency     (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.   "
94106|NCT02054312|"     The investigators proposed a preliminary randomized control trial of Family Based     Interpersonal Psychotherapy (FB-IPT), a family-based adaptation of Interpersonal     Psychotherapy for Depressed Adolescents (IPT-A; Mufson et al., 2000). Forty-five     preadolescent children (ages 8-12) diagnosed with a depressive disorder will be randomized to     receive a 14-week course of FB-IPT or Client Centered Therapy (CCT), a supportive     nondirective psychotherapy that closely approximates treatment at usual in community mental     health clinics. In addition to assessing the feasibility and acceptability of randomization     and each of the treatment conditions, this project will evaluate the effects of FB-IPT and     CCT across multiple domains, including symptomatology and psychosocial functioning.     Preadolescents will be assessed prior to treatment, during treatment (Weeks 3, 7, 11), one     week post-treatment, and at 3 and 6 months post-treatment to compare changes in depressive     symptoms, global, social, and family functioning. Data on psychosocial risk factors     associated with onset and recurrence of preadolescent depression will be collected prior to     treatment and at specified intervals post-treatment in order to conduct exploratory analyses     on correlates of positive and negative treatment outcomes for Family Based IPT. This data     will be used to generate future hypotheses about potential mediators and moderators that will     be incorporated into an R01 application for an efficacy study of Family Based IPT.   "
94107|NCT02054299|"     The purpose of this study is to determine the effect of the organic cation transporter OCT1     polymorphisms on the pharmacokinetics of several drugs in order to explain efficacy and     adverse effects.   "
94108|NCT02054286|"     The objectives of this Phase I/II trial is to evaluate the safety, tolerability and     immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly     active antiretroviral therapies).      THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus):     lentiviral vectors. They are non-replicative and not infectious. They will be injected     intramuscularly, eight weeks apart. Three doses will be assessed and compared to placebo.      36 patients will be enrolled. Eligible patients must have an undetectable viral load and must     be treated by HAART for more than 12 months. They will be randomly allocated to one of the     study group and will receive the experimental drugs at one of the three doses or a matching     placebo.      Their anti-HIV treatment will be alleviated around each experimental drugs' administration to     enable THV01 efficacy. HAART will be resumed one week after the second injection. 15 weeks     after resumption, HAART will be interrupted. Patients will then be monitored every 2 weeks     for CD4+ T cell counts and viral load as well as for thorough assessment of the elicited     immune response. Stringent anti-HIV treatments resumption criteria have been implemented,     based on the CD4+ T cell counts and the viral load.      Statistical analysis will be performed once the last patient has reached his last visit (week     36 or earlier in case of early termination).      A long-term follow-up of all enrolled patients will be performed for 5 years post-prime     administration. This will provide additional data on the safety, on the immune response and     the potential long-term risks/benefits associated with THV01.   "
94109|NCT02054273|"     The objectives of this study is to assess the characteristics and frequency of adenovirus     conjunctivitis in a population of male and female patients from one year of age who present     signs and symptoms of acute conjunctivitis.   "
94118|NCT02054156|"     The purpose of this trial is to compare the effects of treatment with tobramycin solution for     inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6     months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory     culture. Specimens of blood and sputum or throat swabs will be taken during the study along     with pulmonary function testing. Participants will receive initial treatment with TIS     followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa     in addition to either azithromycin or placebo for 18 months.   "
94119|NCT02054143|"     Purpose:        -  The purpose of this study is to examine the effect of different carbon-dioxide          concentrations on cerebral CO2 sensitivity and the resistance and stiffness of systemic          arteries during anesthesia with sevoflurane. Sevoflurane is a widely and commonly used          inhalational anaesthetic, that is mainly used for the maintenance of general anesthesia.        -  Changes in the velocity of cerebral blood flow and arterial stiffness due to the          different exhaled carbon-dioxide concentrations will allow us to conclude how          sevoflurane affects these parameters during the course of the narcosis.      Instruments:        -  An ultrasound device called transcranial doppler (TCD) is used to measure the velocity          of blood flow within a main artery located inside the skull.        -  A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in          the radial artery, from which the stiffness of the systemic vessels can be concluded.      Measurements:      - Examinations with the ultrasound and tonometry devices are carried out once before the     operation, three times during the intervention, with different exhaled CO2 values and once     after the operation is completed.      Hypothesis:      - Sevoflurane alters cerebral carbon-dioxide sensitivity and the stiffness of systemic     arteries.   "
94120|NCT02054130|"     The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929     (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe     asthma.   "
94121|NCT02054117|"     Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other     complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early     phase involves the mechanical compression of brain tissue by the expanding hematoma. In a     later phase, brain swelling develops causing further compression that may lead to brain     herniation and death. This study investigates the neuroprotective role of haptoglobin, in     minimizing the development of brain swelling following intracerebral hemorrhage.   "
94122|NCT02054104|"     Background:      During recent years, cancer-testis (CT) antigens (CTA), particularly those encoded by genes     on the X chromosome (CT-X genes), have emerged as attractive targets for cancer     immunotherapy. Whereas malignancies of diverse histologies express a variety of CTAs, immune     responses to these proteins appear uncommon in cancer patients, possibly due to low-level,     heterogeneous antigen expression, as well as immunosuppressive regulatory T cells present     within tumor sites and systemic circulation of these individuals. Conceivably, vaccination of     cancer patients with tumor cells expressing high levels of CTAs in combination with regimens     that deplete or inhibit T regulatory cells will induce broad immunity to these antigens. In     order to examine this issue, patients with primary lung and esophageal cancers, pleural     mesotheliomas, thoracic sarcomas, thymic neoplasms and mediastinal germ cell tumors, as well     as sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to lungs,     pleura or mediastinum with no evidence of disease (NED) or minimal residual disease (MRD)     following standard multidisciplinary therapy will be vaccinated with H1299 tumor cell lysates     with Iscomatrix adjuvant. Vaccines will be administered with or without metronomic oral     cyclophosphamide (50 mg PO BID x 7d q 14d), and celecoxib (400 mg PO BID). Serologic     responses to a variety of recombinant CTAs as well as immunologic responses to autologous     tumor or epigenetically modified autologous EBVtransformed lymphocytes will be assessed     before and after a six month vaccination period.      Primary Objectives:      1. To assess the frequency of immunologic responses to CTAs in patients with thoracic     malignancies following vaccinations with H1299 cell lysate/Iscomatrix(TM) vaccines alone in     comparison to patients with thoracic malignancies following vaccinations with H1299 cell     lysate/Iscomatrix vaccines in combination with metronomic cyclophosphamide and celecoxib.      Secondary Objectives:        1. To examine if oral metronomic cyclophosphamide and celecoxib therapy diminishes the          number and percentage of T regulatory cells and diminishes activity of these cells in          patients with thoracic malignancies are at risk of recurrence.        2. To examine if H1299 cell lysate/Iscomatrix(TM) vaccination enhances immunologic response          to autologous tumor or epigenetically modified autologous EBV-transformed lymphocytes (B          cells).      Eligibility:        -  Patients with histologically or cytologically proven small cell or non-small cell lung          cancer (SCLC;NSCLC), esophageal cancer (EsC), malignant pleural mesothelioma (MPM) ,          thymic or mediastinal germ cell tumors, thoracic sarcomas, or melanomas, sarcomas, or          epithelial malignancies metastatic to lungs, pleura or mediastinum who have no clinical          evidence of active disease (NED), or minimal residual disease (MRD) not readily          accessible by non-invasive biopsy or resection/radiation following standard therapy          completed within the past 26 weeks.        -  Patients must be 18 years or older with an ECOG performance status of 0 2.        -  Patients must have adequate bone marrow, kidney, liver, lung and cardiac function.        -  Patients may not be on systemic immunosuppressive medications at time vaccinations          commence      Design:        -  Following recovery from surgery, chemotherapy, or chemo/XRT, patients with NED or MRD          will be vaccinated via IM injection with H1299 cell lysates and Iscomatrix(TM) adjuvant          monthly for 6 months.        -  Vaccines will be administered with or without with metronomic oral cyclophosphamide and          celecoxib.        -  Systemic toxicities and immunologic response to therapy will be recorded. Pre and post          vaccination serologic and cell mediated responses to a standard panel of CT antigens as          well as autologous tumor cells (if available) and EBV-transformed lymphocytes will be          assessed before and after vaccination.        -  Numbers/percentages and function of T regulatory cells in peripheral blood will be          assessed before, during, and after vaccinations.        -  Patients will be followed in the clinic with routine staging scans until disease          recurrence.        -  The trial will randomize 28 evaluable patients per arm to either receive vaccine alone          or vaccine plus chemotherapy in order to have 80% power to determine if the frequency of          immune responses on the combination arm exceeds that of the vaccine alone arm, if the          expected frequencies of immune responses on the two arms were 20% and 50%, using a          one-sided 0.10 alpha level Fisher s exact test.        -  Approximately 60 patients will be accrued to this trial.   "
94174|NCT02053428|"     Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating     gastroenteric access through the anterior abdominal wall for nutrition and/ or compression.     Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop     catheters via the push technique are both used at Interventional Radiology for PIG at our     institution. To date, there is no guideline for PIG and no direct comparison of two PIG     techniques. The proposed pilot study is to compare the two different types of PIG techniques     in head and neck cancer patients who require prophylactic enteral feeding by PIG. The purpose     of the study is to assess the feasibility of a large randomized clinical trial to compare     these two PIG techniques.   "
94123|NCT02054091|"     Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered     as the best for the digestive system followed by donor milk. Preterm infant formula is     related to more feeding problems and other gut complications in these babies, such as     necrotizing enterocolitis. Bovine colostrum contains higher amounts of protein, growth     factors and immuno-regulatory components (e.g. immunoglobulins), which has been used in many     other situations to promote health. The investigators plan to give bovine colostrum to     preterm infants with birth weights between 1000 and 1800 g, or born between 27+0 and 32+6     weeks of gestational age, in order to promote feeding and intestinal health in these babies.     This current study is a feasibility pilot study and the investigators hypothesized that     supplementing BC to MM (if available) is safe and tolerable when used within the first 10-14     days of life in preterm infants.   "
94124|NCT02054078|"     Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently     recognized as the most reliable method to control malignant pleural effusion is pleural fixed     or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but     there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as     chest infections, catheter migration and blockage etc. The investigators need a reliable     methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve     quality of life. The purpose of this study was to determine the efficacy and Safety of     intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions     (MPE) in patients.   "
94125|NCT02054065|"     This study proposes to expand upon previous research by studying the effects of a     urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs     with a large, randomized controlled trial within a three-hospital academic medical center.      Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter     days and decrease the number of catheter associated urinary tract infections (CAUTIs), but     will not affect the catheter re-insertion rate.   "
94126|NCT02054052|"     Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs     injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing     effect that produces pleurodesis, which is easy to cause severe chest pain despite of no     influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE.     Bevacizumab has been administrated locally in treating optic nerve sickness successfully by     anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in     treating MPE.   "
94137|NCT02053909|"     Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude     in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including     recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While     aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts     continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin     and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more     pronounced platelet inhibition, and may substantially improve graft patency following CABG     compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on     saphenous vein graft patency following CABG. In this context, the investigators seek to     compare vein graft patency between patients randomized to receive aspirin therapy, the     current standard of care, or ticagrelor treatment, starting in the early postoperative     period, and continuing for 2 years after CABG.   "
94138|NCT02053896|"     The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with     Type 1 Gaucher disease previously treated with Imiglucerase.   "
94139|NCT02053883|"     This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study     designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical     spinal cord injury. During the trial, high and low doses of Cethrin will be compared with     placebo.   "
94127|NCT02054039|"     - Postoperative pulmonary complications in patients undergoing cardiac surgery are a major     clinical problem, presenting negative impact on morbidity, mortality , length of hospital     stay and health care costs. Although physical therapy has been widely used as a resource to     improve lung function in the postoperative period, the adoption of routine procedures of     physical therapy needs be discussed.        -  Incentive spirometers are mechanical devices used to reduce postoperative pulmonary          complications. In general, they are activated by an inspiratory effort, visualized by an          uplifted plate or ball in a transparent cylinder during sustained inspiration.        -  Breath Stacking is a technique allowing the patient inhale a greater volume of air, kept          for a longer period of time using a one-way valve, thus promoting the accumulation of          successive inspiratory volume and preventing exhalation.        -  The objective of the study is to evaluate the effectiveness of two different techniques          of respiratory therapy on both reducing postoperative pulmonary complications and          improving lung function.        -  Type of study : randomized clinical trial        -  Hypothesis             1. Both techniques Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) and Breath               Stacking ( BS ) may present similar effectiveness on reducing pulmonary               complications, improving lung function and respiratory muscle strength ( MIP and               MEP), as well as reducing hospital stay .             2. Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) may be more effective than               Breath Stacking on reducing pulmonary complications, improving lung function and               respiratory muscle strength, as well as reducing hospital stay.   "
94128|NCT02054026|"     The purpose of this study is to evaluate the effectiveness of an eight-hour version of     Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number     of sexual partners, and pregnancy.   "
94153|NCT02053701|"     Magnetic resonance spectroscopy (MRS) allows non-invasive measurement of the concentration of     up to 18 metabolites in the brain (neurochemical profile).      The objective of this proposal is to develop new methods for high-field brain MRS (3 to 7     Tesla).      Our main hypothesis is that higher magnetic fields lead to improved spatial and temporal     resolution and improved quantification precision.      Aims        1. To obtain improved neurochemical profiles in the brain using single voxel proton MRS          at very high field (3 Tesla to 7 Tesla).        2. To develop new methods for proton magnetic resonance spectroscopic imaging (MRSI) to          obtain metabolic maps at very high field (3 Tesla to 7 Tesla).      Since this project is focused on technical development, only healthy volunteers will be     recruited (no patients).   "
94129|NCT02054013|"     Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older     than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such     as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual     dysfunction in some individuals. Medical therapy is usually the first-line treatment.     However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more     invasive treatment options have to be taken into consideration. In cases with moderate to     severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is     the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the     procedure is associated with a complication rate. The cumulative short-term morbidity rate is     around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring     transfusions and transurethral resection syndrome represent potentially serious threats to     elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a     minimal invasive alternative procedure, which can be performed in an outpatient setting with     rapid recovery and low morbidity.      The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH     compared to conventional and established TUR-P.   "
94130|NCT02054000|"     The goal of this study was to evaluate the acute effect of intracoronary administration of     tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow     phenomenon undergoing primary percutaneous coronary intervention (PCI).   "
94131|NCT02053987|"     An Early Supported Discharge (ESD) service for stroke is an evidence based intervention that     aims to enable a particular group of patients who have a mild to moderate stroke to be     discharged from hospital early and receive the same intensity of rehabilitation in their     home. Analysis of almost 1600 patients has demonstrated that ESD can reduce long term     dependency, decrease admission to institutionalized care as well as shorten hospital stay.     This model has also been shown to reduce death and institutionalized care at five years     (Fjaetoft et al, 2011) and has been shown to be cost effective (Saka, 2005.) A study by     National Heath Service (NHS) London showed that patient outcomes has not been affected by     being treated at home and that there have not been an increase in readmissions due to the     setting up of an ESD service.      However, those with moderate to severe strokes are often not eligible for ESD rehabilitation.      This study aims to offer twenty Camden residents an Enhanced Early Supported Discharge     service in which stroke survivors with moderate to severe impairments are eligible.     Participants will be recruited from the University College London Hospital (UCLH)l Hyper     Acute Stroke Unit and acute stroke units at UCLH and the Royal Free Hospital.      This study will compare health and economic outcomes of early Multidisciplinary stroke     rehabilitation in the community compared to traditional inpatient and community     Multidisciplinary rehabilitation for people with moderate to severe post stroke impairments.      We will also collect the views of the participants and their carers regarding being treated     at home.      The objectives are to discover:        1. What impact does the implementation of an Enhanced ESD service for stroke survivors with          moderate to severe impairments have on clinical and cost outcomes compared to an          unchanged care pathway in a neighbouring borough?        2. What are the staff, participant and carer views and experiences of an Enhanced ESD          service?   "
94132|NCT02053974|"     This study sought to investigate the whether spironolactone protects the heart against     anthracycline-induced cardiotoxicity.   "
94133|NCT02053961|"     The study is a double-blind study designed to evaluate the efficacy of deep transcranial     magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the     treatment of patients with tinnitus   "
94134|NCT02053948|"     The use of temporary stomas has been demonstrated to reduce septic complications after     colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to     reduce the number of complications secondary to ostomy takedowns, namely wound infection. The     aim of this study is to compare the rates of superficial wound infection, healing time and     patient satisfaction after pursestring closure vs gunsight skin incision and closure     technique closure.   "
94135|NCT02053935|"     This is a clinical study of a drug named dopamine and how it affects our bodies ability to     make and secrete insulin. Insulin is a hormone made in the pancreas that helps our body     regulate sugar levels. We think that this drug decreases the amount of insulin our body makes     and causes our sugar levels to be high. When you are critically ill there can be many adverse     effects if you have sugar levels that are too high.   "
94136|NCT02053922|"     The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective     Cesarean Section   "
94151|NCT02053727|"     The purpose of this study is to investigate whether the combination of abatacept along with     entecavir (the study drugs) is safe and effective in treating symptoms related to rheumatoid     arthritis (RA).      Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form,     is approved by the FDA for the treatment of RA. In this research, abatacept will be given by     injection. A subcutaneous injection is an injection given under the skin.      Entecavir, to be taken by mouth, is approved by the FDA for the treatment of hepatitis B.      The study is divided into the following time periods:      Screening Phase: Up to 4 weeks Randomized Double-blind Phase: 24 weeks Open-label Extension     Phase: 24 weeksFollow-up Phase: a phone call after Week 48      Each phase contains one or more study visits.   "
94140|NCT02053870|"     This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in     patients with lower respiratory tract infection (LRTI).      Patients will be recruited from a central Hospital and their demographic and anthropometric     data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will     be collected within 24h of the first appointment. Then, patients will be randomly allocated     to either conventional treatment or conventional treatment plus respiratory physiotherapy.     Conventional treatment will consist on daily medical treatment prescribed by the physician.     Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of     breathing retraining and chest clearance techniques, exercises for thoracic mobility,     expansion and flexibility, cardiorespiratory exercise training and education about the     disease.      It is expected that ALS will be responsive to changes in patients' lung function after     treatment. It is also expected that, by including a respiratory physiotherapy component in     the treatment of patients with LRTI, they will express more improvements in a shorter period     of time.   "
94141|NCT02053857|"     To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty     acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as     standard RUTF.   "
94154|NCT02053688|"     The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens,     made of silicone commonly used in the contact lens industry, on healthy eye with or without     astigmatism.   "
94643|NCT02047305|"     Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month     intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse     in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after     baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.   "
94142|NCT02053844|"     This project aims to assess the impact of a web-based health care cost and quality tool that     is being implemented by a health plan for its members. The study will focus on members     working for medium to large employers that have more than 90% of employees enrolled in     deductible and tiered network health plans. The study will use an interrupted time series     (ITS) design that includes random allocation of half of these employers to a study arm that     will receive enhanced promotion of the tool and a $500 lottery incentive for its use in order     to increase take-up. With these two study groups (a high-dose group receiving enhanced     promotion and a lottery, and a low-dose group receiving routine promotion of the tool), the     study will be able to evaluate whether access to a price transparency tool leads to reduced     costs and more value-driven member behavior, and whether extra promotion increases take-up.      Members in the high-dose group who use the tool will be eligible to enter a monthly lottery     to win a $500 prize during the 12-month intervention period. In addition to the lottery,     employers in the high-dose group will receive additional promotional strategies such as a     mailing and messages through the plan's member web portal to promote the tool and the     lottery, and e-mails and flyers for employers to promote the tool and lottery to employees.      The aims of this project are to: 1) examine take-up of the tool and factors that predict     take-up; and 2) to examine the impact of the tool on total and out-of-pocket health care     costs and utilization   "
94143|NCT02053831|"     In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted     and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater     surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.   "
94144|NCT02053818|"     To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of     standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing     coronary artery bypass with or without aortic valve replacement.   "
94145|NCT02053805|"     This will be a prospective diagnostic trial of screening for prostate cancer among men with     genetic predisposition.   "
94146|NCT02053792|"     This study will examine the long-term safety and efficacy of rIX-FP for the control and     prevention of bleeding episodes in children and adults with severe hemophilia B. The study     will include subjects who have not previously been treated with Factor IX products, subjects     who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major     non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study.      A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with     hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy     will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.   "
94147|NCT02053779|"     Purpose:The aim of this project is to prospectively determine whether a single dose of     GnRH-agonist administered at the time of implantation increases or not the reproductive     outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm     injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic     gonadotropin (hCG 1500 IU) the day of oocyte retrieval.      Acronyms:      GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing     hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic     sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing     GnRH-agonist OPU: ovum pick up NaCl: sodium chloride   "
94148|NCT02053766|"     This pilot study is a prospective, randomized clinical trial to evaluate the effect of     anesthesia in the mitochondrial dysfunction patient.   "
94149|NCT02053753|"     To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous     dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2     drug products.   "
94150|NCT02053740|"     Participants and study design:      Subjects were recruited and selected for uremic patients on maintenance hemodialysis (HD) who     informed us of their interest in the investigators study and were mentally capable to give an     informed written consent and willing to comply with study requirements. The inclusion     criteria were 18 years or older, with at least 3 months maintenance HD. The exclusion     criteria were malignancy, acute infection, gastrointestinal bleeding, pregnancy, and     inability to comply with the requirements of study.      69 respondents were enrolled in this trial. A single-center quasi-randomized controlled     clinical trial was designed based on the patients in the care of one attending physician.     Eligible subjects were allocated to study and control group, and the basic characteristics     between the experimental group and control group were matched. There was no significant     difference regarding gender, aged, education level, comorbidities between these two groups.     The experimental group was treated with Ren Shen Yang Rong Tang (R-S-Y-R-T) combined routine     western medicine, and the control group was treated with WM alone. The experimental group had     32 respondents and the control group had 37 respondents. The duration of use of R-S-Y-R-T was     6 months. Finally, there were 27 patients in the experimental group and 32 patients in the     control group completed the study. Blood investigation, including biochemical profiles and     inflammatory markers were checked at intervals 0, 2, 4 and 6 months form routine HD. The     questionnaire, for the assessment of quality of life (QOL) was evaluated at interval 0, and 6     months.   "
94152|NCT02053714|"     Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM).     Unfortunately, persons with mental illness and T2DM are less likely to receive recommended     diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to     microvascular and macrovascular complications later in life. Evidence-based diabetes     self-management education and support interventions have yet to be adapted for persons with     mental illness and there have been no randomized controlled trials (RCTs) to examine their     feasibility and efficacy. The purpose of this study is to assess the feasibility of     conducting a RCT of a diabetes self-management intervention for persons with severe mental     illness and T2DM.   "
94175|NCT02053415|"     The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change     the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the     total fatty acids) in the membrane in red blood cells. We investigate this at two different     doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil     intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid     composition, as well as product tolerance in healthy, young individuals.   "
94155|NCT02053675|"     Vasopressin is a vasopressor used in patients with septic shock. However, its systemic     hemodynamic effects and its microcirculation effects are not completely known and understood.     This study aimed to evaluate the effect of exogenous vasopressin on sublingual     microcirculation using the sidestream dark field technique and to correlate it with its     systemic effects. To this prospective interventional study, patients with septic shock were     included during the first 48 hours of use of catecholamine vasopressors, admitted to the     intensive care unit of a university hospital. Vasopressin was administered at 0.04 U / min     for one hour. Systemic hemodynamic measurements were obtained immediately before and 1 hour     after vasopressin. In addition, images of sublingual microcirculation were collected through     sidestream dark field technology. Further analysis with specific software was done after.   "
94156|NCT02053662|"     To develop a simple blood and urine test that we would perform before patients start their     treatment to predict the risk that their bladder cancer might come back. To develop this test     the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients     and follow them closely during and after treatment. This will include looking for changes in     proteins and genes that might play a role in bladder cancer biology. The investigators will     then compare the information obtained from the studies of blood, urine and cancer tissue     between patients that are cured and those whose cancer comes back. The knowledge about these     differences between patients can then potentially be used to develop a blood or urine test to     tell us who has a high risk for having bladder cancer come back.   "
94157|NCT02053649|"     Perinatal depression is a common and serious mood disorder that increases morbidity and     mortality in new mothers and results in poor infant/child outcomes. Current therapies often     fail to produce recovery or are poorly tolerated and many pregnant women seek     non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not     available. Expectant and new mothers who suffer from circadian rhythm disruption are at risk     for perinatal depression. This R34 Pilot Effectiveness Studies and Services Research Grant     seeks to test whether an Integrated Chronotherapy (IC) intervention can be implemented in an     outpatient psychiatry setting to improve treatment outcomes for patients with perinatal     depression. IC is a multicomponent treatment consisting of bright light therapy, sleep phase     advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC)     constructs of circadian rhythms, sleep-wake behavior, social rhythms, and arousal. We will     assess the feasibility, safety, and acceptability of an IC intervention for perinatal     depressin by testing the treatment in expectant mothers diagnosed with major depressive     disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual     care (UC, n = 20) or (b) IC+UC (n = 20). IC+UC will have pregnancy and postpartum components     and will be administered via an individualized case formulation approach tailored to each     patient. After a baseline assessment, IC will be prescribed during 5 dedicated clinical     visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will     consist of medication administered by a perinatal psychiatrist and/or psychotherapy. UC will     be quantified in both groups to evaluate differences between the IC+UC and UC groups. Mood     will be measured in both groups by blinded clinician interview and patient self-report. We     will assess the safety profile of the IC intervention with evaluation of side effects/adverse     events. Importantly, the study will also examine the putative mechanisms by which IC is     hypothesized to work and the dose of IC received by patients in the IC+UC group. All     participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of     pregnancy and postpartum weeks 2-6 to assess light exposure and sleep duration and timing.     Circadian phase (measured with salivary dim light melatonin onset) will be measured at     baseline during pregnancy (~30 weeks gestation), at 36 weeks gestation, and at postpartum     week 6. This pilot will allow us to refine the IC intervention for future integration into     various clinical settings and establish an infrastructue for a larger (R01-scale) trial,     including measuring acceptability of IC among UC clinicians and implementing web-based data     collection to facilitate data sharing in the planned R01. Perinatal IC could have major     public health impact due to the high prevalence of perinatal depression and its negative     effects on mothers and their children. This project represents a first step toward achieving     this goal, as it will provide the pilot data necessary to prepare for a larger scale     intervention study focused on providing non-pharmacologic therapies and improving outcomes     for women with perinatal depression.   "
94158|NCT02053636|"     The aim of the study is to evaluate the objective response rate (ORR) of single agent     lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with     11q amplification, or FGFR1-non amplified without 11q amplification.   "
94159|NCT02053623|"     Approximately one billion people suffer from hypertension worldwide. At least 10% of this     population, that is, 100 million people, also suffers from associated chronic conditions     namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF).     Personal interaction with medical practitioners (doctors) and review of published clinical     research confirms that current non-invasive automatic blood pressure (BP) monitors that rely     on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak     nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP     estimation can lead to wrong diagnoses and hence to complications such as stokes and heart     attacks.      The Sponsor is developing a novel non-invasive BP monitor that is similar to existing     automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in     conjunction with BP pulse data to provide better and more accurate measurements in the above     chronic conditions.      The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP     monitor against invasive BP measurements in a small group of patients who suffer from the     above conditions.   "
94160|NCT02053610|"     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of     (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles     of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and     day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or     rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil,     or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for     disease-progression and safety will be at least 5 years. In the US, this trial is     sponsored/managed by Genentech.   "
94161|NCT02053597|"     Recently, there has been a rising trend of delaying childbearing and hence more women are     diagnosed with breast cancer before completing their families. Given the continuous decline     in recurrences and death secondary to breast cancer and the reassuring data on the safety of     pregnancy following breast cancer more women are inquiring into the possibility of preserving     fertility following chemotherapy. The challenge remains in using a regimen that is devoid of     cyclophosphamide, but is as effective as the standard regimens that incorporate     cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP)     followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with     convincing results regarding its effectiveness in the early setting, and could be potentially     associated with less ovarian toxicity being devoid of cyclophosphamide.   "
95108|NCT02041221|"     Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound     SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the     safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending     doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.   "
94162|NCT02053584|"     The study is performed to evaluate the accuracy of blood glucose level results obtained from     fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference     equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the     lay-person.      The participants will review the Dario user manual and guide and will be requested to operate     the Dario BGMS and perform their own glucose blood test, after which they will be asked to     complete a questionnaire. As reference the participants will be tested by professional     caregivers both using the Dario BGMS and by YSI 2003.   "
94163|NCT02053571|"     The goal of this study is to evaluate an alternate approach, which involves using a 3D     puncture path overlay, to access the portal vein during a Transjugular Intrahepatic     Portosystemic Shunt (TIPS) procedure. The study should determine if the alternate approach     provides these benefits: improved safety of procedure, and reduced intervention time     (including reduction of radiation exposure), which benefits both interventional radiologist     and the patient.      During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the     vein above the collarbone in the neck) using fluoroscopy (x-ray) guidance. The shunt then is     inserted between the portal vein (vein that carries blood from the digestive organs into the     liver) to a hepatic vein (vein that carries blood away from the liver back to the heart).      In the standard approach, the interventional radiologist uses two-dimensional guidance (2D -     having the dimensions of height and width only) to locate the path between the portal vein     and hepatic vein. However, since these two veins do not connect, this method does not provide     information on the three-dimensional (3D) relationship between the two veins.      In the alternate approach, the physician will have the option of using 3D guidance to locate     the path. An on-table limited (small field of view) CT scan, used in combination with FDA     approved imaging software, will provide a 3D image demonstrating the relationship between the     portal vein and the hepatic vein. The 3D image is overlaid on the standard live x-ray images     to assist in needle guidance during the TIPS procedure.      The CT scan performed will be in place of the angiograms that are typically performed.     However, if the portal vein is not adequately seen in the CT images, the angiograms will be     done and there will be no overlay. The procedure will proceed using the standard approach.   "
94164|NCT02053558|"     It has been demonstrated that female patients have poor quality of surgical recovery compared     to male patients. Increased sensitivity to pain and increased susceptibility to postoperative     nausea and vomiting have been attributed as causal factors. Currently, few strategies have     been shown to improve quality of recovery in female patients undergoing laparoscopic     hysterectomy. A better recovery in female patients undergoing outpatient laparoscopy is     particularly desirable since those patients do not have access to potent intravenous     medications and nursing support after hospital discharge.      Our group has previously demonstrated that both TAP block and systemic lidocaine improve     quality of recovery after outpatient laparoscopic gynecological surgery. The TAP block,     however, requires expertise, equipment (ultrasound), and additional time to perform as     compared with a simple lidocaine infusion. It is currently unknown if a systemic lidocaine     infusion provides non-inferior quality of recovery when compared to TAP block for outpatient     laparoscopic gynecological surgery.      The main objective of the current investigation is to examine the effect of TAP block on     quality of recovery compared to a systemic lidocaine infusion. We hypothesize that systemic     lidocaine infusion would provide non-inferior quality of recovery when compared to TAP block     for outpatient laparoscopic gynecological surgery.      Significance: This is the first study to compare systemic lidocaine to TAP block with regard     to quality of recovery.      The research question; does systemic lidocaine provide similar quality of recovery as TAP     block for outpatient laparoscopy? The hypothesis; systemic lidocaine provides non-inferior     quality of recovery as TAP block for outpatient laparoscopy.      Research significance: It has been shown that females have poor surgical recovery compared to     males; this project intends to demonstrate that systemic lidocaine provides similar recovery     as TAP blocks but it does not require the expertise, equipment, and time needed to perform     TAP blocks.   "
94165|NCT02053545|"     Although a majority of children with leukemia and most hematological malignancies (Hodgkin's     and Non-Hodgkin's lymphomas) can be cured with conventional chemotherapy, a subset of     patients with resistant/recurrent high-risk disease are not cured with conventional treatment     regimens. Investigators hypothesize that HSCT from a partially matched donor can be safe and     effective for patients with very high risk hematologic malignancies when combined with     post-transplant cyclophosphamide for prevention of graft-vs-host disease (GVHD).   "
94166|NCT02053532|"     Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of the     amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to     abnormalities of hippocampal volume. In this pilot study we propose to use the combined     positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose     (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and     directly correlate the data with the intrinsic functional connectivity of brain circuits that     are responsible for social, emotional and cognitive processing in both individuals with PTSD     and group-matched trauma controls (TC) and healthy controls (HC). Once the machine is     validated, we will then use a more specific biomarker to better understand the neurochemical     factors that contribute to individual differences in PTSD. Thus, the data obtained from this     pilot study will guide our future molecular imaging studies. The link between general brain     function, specific molecular target and the intrinsic functional connectivity of brain     circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and     HC will be explored.   "
94167|NCT02053519|"     Evidence suggests that vitamin D may be directly or indirectly a co-factor for the efficacy     of Hepatitis C virus, (HCV), antiviral therapies. The level of vitamin D necessary for     optimum immune function is ill defined and many of those with HCV infection in Scotland are     below these levels. Vitamin D is a cheap and safe medication, so its addition to anti-viral     therapy should be highly cost-effective even if only a modest increase in SVR was achieved.     Given the Scottish HCV epidemic, the world leading government response to it and the     nationally low vitamin D levels, Scotland is perfectly placed to answer this question.     Therefore the investigators hypothesize that vitamin D supplementation will improve SVR and     propose a randomised controlled trial to test this hypothesis. The anticipated end of study     date for this study is April 2015   "
94168|NCT02053506|"     Physical and psychological stress on military personnel during training and operational     missions can suppress immune function. Creating superficial skin wounds via suction blisters     can be used to detect changes in immune function. The goals of this research are to: 1)     identify changes in immune function (blood measures and healing time of skin wounds) in     response to sleep restriction; and, 2) test the influence of a multi-nutrient beverage and     healthy bacteria (i.e., probiotics) on immune function (blood measures and healing time of     skin wounds) in response to sleep restriction.   "
94169|NCT02053493|"     A randomized, double-blinded, placebo-controlled crossover study to assess effect of     isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn,     tri-axial) accelerometry.   "
94170|NCT02053480|"     The purpose of this study is to describe the range and incidence of symptoms, treatments, and     complications related to pyruvate kinase deficiency (PKD). Eligible patients are those of all     ages with known PKD or with a hemolytic anemia and a family member with PKD. The study will     collect retrospective medical history, routine clinical care data, and quality of life     measures at baseline and annually for patients with PKD.   "
94520|NCT02048917|"     The purpose of this study is to find an optimal smoking cessation strategy in patients     undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky     by delivering high quality smoking cessation to all enrolled patients. This study will also     examine the feasibility of routinely implementing an array of smoking cessation strategies     for this patient population.   "
94171|NCT02053467|"     The consultation-referral process is complex, involving several steps including 1) the PCP     recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the     specialist, 3) referral letter and information sent to specialist, 4) appointment booked and     communicated, 5) patient visit(s) with the specialist and 6) communication back to the PCP.      There are many factors during this process which limit the effectiveness and efficiency of     patient care. These include inequitable access for patients and providers, long wait times     before specialist advice received/implemented, delayed communication and mismatched consult     expectations. These gaps result in significant breakdowns in transitions of care,     inappropriate treatment, patient dissatisfaction and potential harm. Moreover, not all     individuals are willing or able to travel to see specialists in a large academic medical     centre even when recommended by the PCP.      eConsultation has the potential for improving transitions in care through improved     communication ensuring that patients are seen by the right specialist, when necessary, with     the right information and in a timely manner. The goal of this project is to evaluate the     impact of eConsultation on specialist referral rates.   "
94172|NCT02053454|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)     of patisiran (ALN-TTR02) in Japanese subjects   "
94173|NCT02053441|"     In this study will measure differences in how muscle responds to both exercise and protein     supplements in healthy women aged 60-69. We are studying two different protein supplements- a     standard Whey Protein and a Leucine enriched supplement. Each patient would receive either     one of these.   "
94176|NCT02053402|"     The aim of this randomized double-blind placebo controlled study is to assess whether vitamin     D supplementation will improve control in South African children with persistent asthma at an     academic hospital.      The following hypotheses will be tested: Vitamin D significantly and directly correlates with     poor control of persistent asthma; Daily vitamin D supplementation for six months will result     in improved control of persistent asthma compared to a placebo.      It is intended to enroll 100 children between the ages of 6 to 12 years with persistent     asthma on inhaled therapy. The sample size calculations are based on the hypothesis that     vitamin D supplementation will result in a 25% improvement in asthma symptoms as measured by     the Asthma Treatment Assessment Questionnaire (ATAQ) and peak flow readings. The children     will be randomized into one of two groups; one group will be given 1200 IU of vitamin and the     other a placebo. The vitamin D or placebo will be given in the morning daily to each child     for six months. The children will be assessed monthly by the study physician, to evaluate for     signs of poor asthma control e.g. persistent cough and recurrent wheezing. The heights and     weights and peak expiratory flow meter readings will also be obtained monthly for six months.     Blood samples will be taken for Vitamin D levels, calcium, phosphorus levels at baseline,     third month and at the end of the study. All enrolled children will be required to produce     their tablet containers for pill counting on a monthly basis to ensure adherence.   "
94177|NCT02053389|"     This is an educational intervention study testing the effects of decision aids in promoting     patient participation in early stage prostate cancer treatment decision making. The purpose     of this study is to compare patient-physician communication between patients who receive a     DVD that models patient communication strategies vs. those who do not receive a DVD. All     patients will also receive a written decision aid that describes treatment options for early     stage prostate cancer. The Investigators hypothesize that the DVD will:        -  increase patients' perceptions of the importance of their preferences to their decision          making        -  increase patients' perceptions of their intention to discuss their values and          preferences with their urologists and radiation oncologists        -  increase patients' actual engagement with their physician during the clinical encounter        -  increase the concordance between patient decision making preferences and actual decision          making outcomes        -  increase long term satisfaction with decision on type of treatment selected        -  increase patient satisfaction with their decision and the decision making process        -  influence patient perception of his physician (e.g., trust) and of the diagnosis visit   "
94212|NCT02052934|"     A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and     immunogenicity of a multi-dose regimen in healthy adult volunteers. The study will be     conducted at Cincinnati Children's Hospital Medical Center (CCHMC). The primary objectives     assess the safety and tolerability of dmLT vaccine when administered in three doses     sublingually over a range of dosages in healthy adult subjects. The secondary objectives     assess long-term safety follow-up from immunization through Month 7 post vaccination,     following three SL doses of dmLT vaccine over a range of dosages and comparing with three     doses of a comparable dosage of oral vaccine. The study subject population is 52 healthy     adult male and female subjects, ages 18 to 45. Subject participation duration is     approximately 8 months with study duration of approximately 1.5-2 years, including 6-7 months     of follow-up.   "
94937|NCT02043470|"     The investigators propose using retinal oximetry to assess for abnormalities in regional     retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities     to changes in regional retinal function (i.e. visual field abnormalities). Since different     regions of retina receive different radiation doses, the investigators will assess for a dose     response as well.   "
94178|NCT02053376|"     As noted, multiple pathways, including epidermal growth factor receptor (EGFR), Ras, Raf,     Vascular Endothelial Growth Factor Receptors (VEGFR), and platelet-derived growth factor     (PDGFR) appear to be involved in cholangiocarcinoma tumor genesis. Overexpression of these     proteins has been shown to be associated with tumor stage, prognosis, and response to     therapy. However, therapies targeting a single pathway have shown no clear benefit. A number     of Phase 2 trials have been completed, or are underway, studying agents targeted to EGFR or     VEGF - both as monotherapy and in combination with chemotherapy. These have shown varying     increases in response rate, but have not found marked increases in progression-free or     overall survival. This suggests that inhibition of multiple pathways simultaneously may be     needed. Regorafenib, is an oral multikinase inhibitor targeting multiple tumor pathways,     which has showed effectiveness as a single agent in multiple solid tumors.      The primary objective of this clinical trial is to evaluate the progression-free survival     (PFS) of patients receiving regorafenib after failing first-line chemotherapy. Patients with     advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been     treated with and failed first-line chemotherapy will be treated with regorafenib (160 mg)     orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.   "
94179|NCT02053363|"     The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an     anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex,     reconstructive spinal fusion surgeries.   "
94180|NCT02053350|"     The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the     treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with     standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality     and recurrent disease.   "
94181|NCT02053337|"     ALLEVYN◊ Life and Mepilex™ Border are both layered foam dressings with a silicone adhesive     wound contact layer. Both are indicated for the same uses; however ALLEVYN◊ Life has a number     of attributes designed to meet a range of characteristics associated with principles of     wellbeing.      The aim for this evaluation is to assess, in a clinical setting and against a number of     identified criteria, the performance of the ALLEVYN◊ Life dressing compared to Mepilex™     Border in terms of characteristics of the attributes of wellbeing.      ◊ Trademark of Smith & Nephew      ™ All trademarks acknowledged   "
94190|NCT02053220|"     To assess the pattern of ColoAd1 viral delivery and viral expression within colon tumour     tissue when administered by intra-tumoural injection or within colon, non-small cell lung,     bladder and renal cell tumour tissues following ColoAd1 administration by intravenous     infusion.   "
94182|NCT02053324|"     The purpose of the study is to assess a new treatment for patients with liver tumor     metastases from colorectal cancer. The treatment has never been used in humans before. The     treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin.      AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while     [177Lu]DOTA-biotin is a new chemical compound resulting from the combination of the     DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an     atom which emits radiation.      AvidinOX will be injected directly into the metastases in the liver and [177Lu]DOTA-biotin     will be injected into the arm vein.      One specific property of AvidinOX is that it chemically links to the tumor tissues when it is     injected while maintaining the capacity to take up [177Lu]DOTA-biotin. Once locally bound in     tumor tissue, AvidinOX becomes an artificial receptor for intravenously injected     [177Lu]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue.      The treatment of liver metastases with local injection of AvidinOX and the following     intra-venous injection of [177Lu]DOTA-biotin could be simpler and more tolerable than the     current available treatments.   "
94183|NCT02053311|"     The main object of this multicenter, randomized, double-blind, placebo-controlled phase III     trial is to assess impact of maintenance of orteronel on disease progression and hence on     quality of life of patients with metastatic castration resistant prostate cancer pretreated     with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.   "
94184|NCT02053298|"     Glaucoma is an optic neuropathy in which the main risk factor is intraocular pressure (IOP).     The search for other variables involved in glaucoma pathogenesis and progression has     identified both systemic and ocular signs of vascular dysfunction in glaucoma patients, such     as migraine, peripheral vasospasm, systemic hypotension and cerebral microvascular ischemia.     Ocular blood flow studies using Color Doppler Imaging (CDI) technology has demonstrated blood     velocities and increased vascular resistance (RI) to exist in such patients when compared to     healthy controls. However, a CDI examination provides far more additional information, such     as arterial pulsatility (PI) and mean blood velocities (MFV). While these have been used for     decades now to study cerebral arteries vasoreactivity, little is known about how these     variables are changed in glaucoma patients. We have recently demonstrated that these     variables can be used to identify a change in the normal vascular activity when there is     increased resistance. In glaucoma patients, a cutpoint in RI of the retrobulbar arteries     could be determined beyond which PI increased significantly. This sharp increase in the PI     has been used as an indirect signal that the vessel's ability to buffer a decreased perfusion     pressure has been surpassed. The normal response to a decreased perfusion in a vascular     territory with autoregulation is an increase in dilation in the downstream microcirculation,     increasing cross section area in an attempt to keep a steady MFV. As PI is calculated using     the vessel's MFV [PI = (PSV-EDV)/MFV], it is highly sensitive to changes in this variable. As     such, the cutpoints we have identified in glaucoma patients are therefore an indirect     assessment of the vessel's autoregulation limit.      While our data could provide the rational as to why these RI values are associated with     progression, the clinical question arises as to whether these cutpoints can be modulated by     topical glaucoma therapy. As some medications such as carbonic anhydrase inhibitors have been     found to have a positive effect in disease progression in what appears to be a non-IOP     related effect, we considered the hypothesis that these drugs could have a positive impact on     the ocular's microcirculation vasoactive response, potentially enabling to keep a steady MFV     into higher values of vascular resistance.   "
94185|NCT02053285|"     Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As     tumors respond to treatment, preliminary data suggests that the blood volumes changes as     well. Investigators are therefore using DECT to test whether it can be used on radiation     treatment to rapidly assess response to treatment.   "
94186|NCT02053272|"     A study to compare the change in glycaemic control in participants with Type 2 diabetes when     treated with GWP42004 or placebo as add-on therapy to metformin over a period of 12 weeks.     The safety and tolerability of GWP42004 compared with placebo will also be assessed.   "
94239|NCT02052570|"     This is a qualitative study that will explore the experiences of school reentry following     Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents,     teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study will     involve four focus groups: children post -transplant, parents, teachers and PBMT providers in     an effort to understand the successes and challenges of returning to school following HSCT.   "
94952|NCT02043275|"     The purpose of this study is to determine if jump landing mechanics in young female athletes     can be improved with a resistance training intervention.   "
95109|NCT02041208|"     The purpose of this study es to determine hemoglobin variability in kidney transplant     recipients with chronic renal anemia.   "
94187|NCT02053259|"     The purpose of this study is to develop and evaluate adaptive goal setting and feedback     interventions (Adaptive Interventions) to promote physical activity behaviors and compare it     to static physical activity interventions (Static Interventions) using two levels of goal     setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures     (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All     four groups will receive the intervention via a semi-automated text message system developed     by the investigators study team.      The primary aim of this study will be to:        1. Evaluate whether the adaptive interventions result in greater change in physical          activity (pedometer-measured steps/day) compared to the static Intervention groups.          HYPOTHESES: Participants in the adaptive interventions will increase their steps/day          more than participants in the Static Intervention groups. The Adaptive Goals and          Reinforcement Group will outperform the other 3 groups.           The secondary aims of this study will be to:        2. Evaluate the effectiveness of the adaptive and static goal interventions in improving          anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES:          Participants in the adaptive interventions will show greater improvements in fitness,          lean and fat body mass, and serum biomarkers than participants in the Static          Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the          other 3 groups.        3. to assess participants' satisfaction with the overall program.   "
94188|NCT02053246|"     Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of     pulmonary hypertension (PH). Despite the severity of this disease, no established treatments     exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart     failure, but not used in patients with PH. Due to some additional properties it possesses,     the investigators believe nebivolol will improve disease severity in patients with PH     associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH     severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.   "
94189|NCT02053233|"     The robot assisted therapy is one of the new developed technologies for recovery after     stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery     after stroke.   "
94192|NCT02053194|"     The objective of this trial is to test the beneficial effect of a pharmacist-initiated     knowledge transfer intervention to both patients and prescribers on the discontinuation of     inappropriate prescriptions, compared to usual care. The investigators hypothesize that the     pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over     6-months compared to usual care. The intervention consists of simultaneously educating     consumers and providing physicians with an evidence-based pharmaceutical opinion on     inappropriate prescriptions.   "
94193|NCT02053181|"     The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in     subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the     quantity of cadazolid absorbed into the systemic circulation.   "
94194|NCT02053168|"     Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring     primary ventral and incisional hernias.   "
94195|NCT02053155|"     Implementation of a perioperative smoking cessation program with computer based patient     education increases the rate of short term (1 month) and long term (6 month) reduces the     incidence of perioperative complications in elective surgical patients.   "
94196|NCT02053142|"     This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response     to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.   "
94197|NCT02053129|"     This is a pilot pulmonary TB screening program done in three antenatal care clinics in     Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and to     determine the sensitivity and specificity of symptom-based TB screening.   "
94198|NCT02053116|"     A Phase 2a study to evaluate the effects of an investigational compound administered at 200     mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2     Diabetes Mellitus (T2DM).   "
94199|NCT02053103|"     A Phase 2a study to evaluate the effects of an investigational compound administered at 200     mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on     metformin background therapy.   "
94200|NCT02053090|"     This study is an acceptability and feasibility study of two adjunctive interventions: group     education with stretching; and group acupuncture. The study population will be women with     primary fibromyalgia who have not previously used acupuncture in the last 3 months. Both     interventions will be 10 weeks in length and will be conducted at the Oregon Health & Science     University. The primary hypothesis is that both arms will be acceptable and feasible in the     study population.   "
94201|NCT02053077|"     Identification of risks of the GlucoTab system in routine use.   "
94202|NCT02053064|"     P2-SAF-301 is an open-label interventional study without administration of investigational     product, evaluating the long-term safety and tolerability of intracerebral SAF-301 previously     administered to 4 patients with Sanfilippo type A syndrome.      The primary objective is to collect additional safety and tolerability data on intracerebral     SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.      The secondary objective is to further collect data to assess the effects of SAF-301 on     neurological and psychological status, and potential biological markers.   "
94240|NCT02052557|"     The purpose of the study is to evaluate the effect of Exparel on pain control and patient     outcome after colon resection. The investigators will evaluate the clinical course of the     patients who receive exparel as compared to the patients who do not receive exparel. Exparel     is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three     days. A long acting local anesthetic should provide better pain control than conventional     bupivacaine which has a 3.5 hour half-life.   "
94203|NCT02053051|"     This study aims to assess the safety and efficacy of a novel advanced bolus calculator in     subjects with Type 1 diabetes. Insulin bolus calculators have been developed to aid insulin     dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm     that requires five subject-specific parameters as input to generate a recommended bolus     insulin dose:        -  current blood glucose (mmol/L)        -  target blood glucose (mmol/L)        -  insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin)        -  total grams of carbohydrate in meals        -  insulin sensitivity factor (reduction in glucose per 1 unit of insulin)      The Diabetes Technology team at Imperial College have developed a novel advanced bolus     calculator. The complete integrated system consists of a commercially available smartphone     that holds the novel advanced algorithm. The system requires regular updates of cases derived     from retrospective blinded continuous glucose monitoring data and for this a commercially     available glucose sensor will be used. Each new case includes information about the problem     (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended     insulin dose) and outcome (blood glucose following a meal). The novel decision support     algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique     that tries to solve newly encountered problems by applying the solutions learned from solved     problems encountered in the past.      The end-product is therefore a subject specific insulin bolus calculator that continues to     improve with time. The project utilises commercially available glucose sensors and     smartphones (iPhone), integrated with a novel algorithm for insulin bolus calculation. The     aim of the ABC4D is to minimise high and low glucose excursions which are associated with the     complications of diabetes including blindness, kidney failure, nerve damage and     cardiovascular disease.      The clinical study has been designed to incrementally assess the device's ability to manage     meal time insulin requirements at breakfast and lunch in a controlled supervised clinical     environment over 8 hours (phase 1), followed by its use in the home environment over a 6 week     period (phase 2) and finally over a 6 month period (phase 3).   "
94204|NCT02053038|"     Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But     patients may have more than one narrowing and studies have shown that not all narrowings need     to be treated. To identify the narrowings that need treating cardiologists sometimes quantify     the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of the     pressure in the aorta to the pressure downstream of the narrowing).This technique requires     the administration of drugs that add cost and time to the procedure and in some countries are     simply unavailable. As a result despite the clear health and healthcare costs benefits of FFR     its use is limited to less than 5% of procedure. We have developed a new technique called the     instantaneous wave-free ratio (iFR) that does not require the administration of drugs for its     accurate assessment. It has been approved for use in this indication. This study aims to     compare clinical outcomes of patients whose treatment has been guided by iFR to those whose     treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as     FFR its adoption will permit the clear benefits of this approach of identifying the coronary     narrowings that really need treatment to be applicable to a much larger patient population     and further improve healthcare costs.   "
94205|NCT02053025|"     The purpose of this study is to investigate the effect of eating various levels of     mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in     overweight volunteers.   "
94209|NCT02052973|"     This study aims to evaluate the effectiveness of a varnish containing 15% of green propolis     on Streptococcus mutans in saliva and biofilm. Will be invited to join the study: children     8-10 years old, free of caries, without orthodontic appliances and without having undergone     antibiotic therapy until three weeks before the start of the study. Saliva will be collected     before, immediately after, 24 hours and 30 days after application of the varnish. The     collection of biofilm will be performed before, after, 24 hours and 30 days after application     of the varnish. Data will be collected and compared between periods.   "
94210|NCT02052960|"     The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients     with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in     combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).   "
94211|NCT02052947|"     One of the crucial challenges for the future of Alzheimer's disease (AD) therapeutic     approaches in elderly is to target the main pathological process responsible for disability     and dependency. However, a progressive cognitive impairment occurring after the age of 70 is     often related to mixed lesions of neurodegenerative and vascular origins. Whereas young     patients are mostly affected by pure lesions, aging favors the occurrence of co-lesions of     AD, vascular and Lewy body types. Pure DLB (Dementia with Lewy Body) and AD are distinct     disorders but they often coexist in old age patients, the Abeta pathology of DLB/AD cases     being different to that observed in patients with AD alone. Vascular dementia (VD) and AD     with cerebrovascular disease (AD+CVD) are the leading causes of dementia next to AD alone.     Lack of consensus persists about the diagnosis criteria for VD and AD+CVD, due in part to     their clinical, pathological heterogeneity and the multiple pathological subtypes.      We do not know the precise role and weight of each brain lesion type in the disability     progression in elderly. To target the actual pathological process, we need to disclose the     functional weight of AD, Lewy body and vascular lesion types in elderly. Most of the studies     report on functional and clinical abnormalities in patients with pure pathologies. Thus,     co-morbid processes involved in the transition from an independent functional status to     disability in the elderly with co-lesions still remain to be elucidated. Neuropathological     examination often performed at late stages cannot answer this question at mild or moderate     stages.      Brain MRI, Single Photon Emission Computed Tomography (SPECT) with DaTscan® and CSF     biomarkers help routinely in performing the diagnosis of pure or mixed lesions responsible     for dementia. The topography of the atrophy in MRI helps to provide information about the     etiological diagnosis. Medial temporal lobe atrophy on MRI has good discriminatory power for     AD compared to DLB and VD in pathologically confirmed cases. DaTscan® SPECT presents with     good sensitivity and specificity at early stages of DLB. The good diagnosis value of CSF     biological markers has led recently to their inclusion in the research diagnosis criteria of     AD. Low Aβ1-42 and high levels of total tau and hyperphosphorylated tau isoforms appear to be     the most sensitive and specific CSF biomarkers. Aβ1-42 is lowered in AD, as well as in other     neurodegenerative diseases like DLB, VD. The combination of MRI, particularly medial temporal     atrophy measures and vascular lesions on FLAIR MRI sequences, SPECT and CSF biomarkers seem     to be of incremental value for the diagnosis AD, VD, DLB and mixed profiles.      The aim of this study is to identify the biomarkers (MRI, SPECT-DaTscan® and CSF), and their     combination, that are the most predictive of functional disability in elderly presenting with     a progressive cognitive decline related to AD, DLB, VD and all mixed patterns.   "
94241|NCT02052544|"     To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to     aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing     heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k)     submission.   "
94242|NCT02052531|"     The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by     comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific     Corporation in patients with dermal pruritus.   "
94213|NCT02052921|"     With the possibility of pathological complete response in surgical specimens, some authors     have proposed non-operative management of the patient group, when re-staged after neoadjuvant     treatment, have complete clinical response. So far, this approach remains discussed in the     literature, and there are still many uncertainties that patients with clinical complete     response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of     radical surgical treatment. It is a still investigational approach and actually gained space     even for patients with very high or who refuse surgery after all clarifications surgical     risk.      Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and     distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant     chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who     underwent surgical rectal resection.      This will be a prospective, randomized, open label phase II of surgical resection versus     conservative treatment (observation) in patients with mid and distal rectal cancer who     achieved complete after neoadjuvant chemoradiotherapy combined with clinical response.      The main objective of this study is to assess whether conservative approach is similar to     rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum     in patients with complete clinical response after neoadjuvant therapy combined     chemoradiotherapy.      Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of     rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical     response after treatment with chemoradiotherapy for rectal tumors staged clinical and     radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors.      Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The     period for randomization of patients will be 12 weeks after the last dose of radiotherapy /     chemotherapy, so that we can properly assess the antitumor response as described above. After     randomization, patients in the surgical group will undergo resection of the rectum with     complete excision of mesorectal within 2 weeks after randomization.   "
94214|NCT02052908|"     This randomized phase Ib trial studies the side effects and best dose of naproxen in     preventing deoxyribonucleic acid (DNA) mismatch repair deficient colorectal cancer in     patients with Lynch syndrome. Chemoprevention is the use of certain drugs to keep cancer from     forming. The use of naproxen may keep cancer from forming in patients with Lynch syndrome.   "
94215|NCT02052895|"     This is an observational study to evaluate the diagnostic accuracy of presepsin levels to     discriminate between sepsis and SIRS upon presentation with critical illness compatible with     either sepsis or systemic inflammatory response syndrome (SIRS).   "
94216|NCT02052882|"     This study is to determine if using weekly romiplostim injections will improve the patient's     platelet count more effectively than simply waiting for the platelets to improve on its own,     and if romiplostim will also allow the patient to receive at least 2 further cycles of     chemotherapy without thrombocytopenia.   "
94217|NCT02052869|"     In endotracheal intubation, it is essential that the trachea is intubated and not the     esophagus. In suboptimal situations (outside an operating theatre), malpositioning of the     endotracheal tube occurs frequently and is often fatal. The diagnostic tools that are     available in the operating theatre are not appropriate for out-of-hospital situations because     of several reasons. Moreover, these methods mostly take some time to provide the desired     information and don't have optimal specificity and sensitivity. In order to allow fast     diagnosis of this potentially fatal complication, we have developed a fully-automatic     detection device to diagnose endotracheal tube malpositioning within 2 seconds.      A high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in     healthy patients and patients with pulmonary diseases (decreased pulmonary compliance).      A new stand-alone device with integrated sensors and microprocessor was developed that gives     immediate diagnosis, and stores data for subsequent research purpose. This device will be     evaluated in perioperative situations to demonstrate the high sensitivity and specificity in     patients in a clinical setting.   "
94336|NCT02051309|"     Adult daily smokers motivated to quit smoking will be randomized to extended-release     guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining     medication with brief behavioral support. The investigators hypothesize that the active dose     of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the     end of the 8-week treatment phase.   "
94218|NCT02052856|"     The purpose of this study is to evaluate the incidence and degree of bone tunnel widening     between two groups who have undergone anterior cruciate ligament reconstructive surgery. The     two groups have undergone different graft fixation methods: an interference screw/suspensory     button fixation hybrid technique, and an all-inside suspensory method fixation. Tunnels are     created at the time of surgery for graft placement and fixation, but have been known to     enlarge post-operatively. Little has been studied on the relatively new all-inside technique.     X-rays of the operative knee will be used to assess tunnel width. Secondary outcomes will     include clinical evaluation and outcome scoring questionnaires   "
94219|NCT02052843|"     The evaluation will examine whether the Steps to Success enhanced home visits are more     effective at delaying repeat pregnancies than are traditional Healthy Families home visits.   "
94220|NCT02052830|"     The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying     sexual initiation on adolescent males in Eastern Iowa.   "
94221|NCT02052817|"     The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and     has been shown to heal ulcers at a rapid rate in preliminary experience in patients with     plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based     on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates     of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the     Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates     will be determined clinically and by blinded, computer-assisted planimetry of digital images     over a 12 week period. The pressure on the plantar surface will be measured via a pressure     sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on     the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.   "
94222|NCT02052804|"     The objectives of this study are: 1) to design new diagnostic criteria used to accurately     define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk     factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular     mechanisms involved with the development and progression of HFpEF; 4) to design and test new     therapeutic strategies for patients with HFpEF.   "
94223|NCT02052791|"     The primary objective of this study is to examine the safety and tolerability of nusinersen     (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA)     who previously participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10     (NCT01780246). The secondary objective is to examine the plasma and cerebrospinal fluid (CSF)     pharmacokinetic(s) (PK) of nusinersen administered intrathecally to participants with SMA who     previously participated in ISIS 396443-CS2 or ISIS 396443-CS10.   "
94224|NCT02052778|"     The purpose of this study is to determine the safety of TAS-120 and determine the most     appropriate dose for the subsequent phase 2 safety and efficacy study in patients with     advanced solid tumors and multiple myeloma with genetic abnormalities.      The progression of cancers is caused by a complex series of multiple genetic and molecular     events leading to changes in the patients DNA. The fibroblast growth factor/fibroblast growth     factor receptor (FGF/FGFR) signaling pathway is important for normal organ, vascular and     skeletal development. However, FGFR gene abnormalities have been linked to various cancers.      TAS-120 is a highly potent, selective small molecule inhibitor of FGFR and is therefore is     being studied as a therapy for cancer.   "
94225|NCT02052765|"     Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology     of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time. Patients     presenting a Brugada syndrome are exposed to sudden cardiac death, although it's difficult to     predict patients at high risk. It is suspected that the type 1-ECG burden might be correlated     to the ventricular fibrillation risk of these patients, but there is no mean to record the     ECG over a long period of time.      The objective of the study is to evaluate the correlation between ST elevation on the     electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with the     AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients enrolled     in the study are patients already implanted with a defibrillator for their Brugada syndrome.     During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and surface ECG     will be compared to assess the detection of the typical ST-shift by the ICD.   "
94226|NCT02052752|"     5 Day study to assess how quickly a topical acne product begins to work.   "
94227|NCT02052739|"     The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in subjects     in super-refractory status epilepticus (SRSE).   "
94228|NCT02052726|"     This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85     years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at     either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups     (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is,     and also look at subjects' immune response to the vaccine.   "
94229|NCT02052713|"     The purpose of this study is to assess the bioequivalence of the second generation     dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available     commercial combination of dutasteride 0.5 milligram (mg) and tamsulosin HCL 0.4 mg capsule in     healthy adult male subjects. Subjects in this study will receive either a single oral dose of     the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a     single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL     0.4 mg followed by a 28-day washout period both in fasted state. The study will enroll     approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable     subjects. The total duration of a subject's involvement in this study is anticipated to be     approximately 12 weeks.   "
94230|NCT02052687|"     The purpose of this first-in human study is to demonstrate systemic and local tolerability     and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy     subjects.      The current study has been designed with three distinct parts. Part 1 focuses on safety and     tolerability of once daily application on the back, prior to moving forward and assessing the     safety and tolerability in more sensitive treatment areas in Part 2 or twice daily     application in Part 3.   "
98646|NCT01994967|"     Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose     of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in     spinal anesthesia.   "
94231|NCT02052674|"     The purpose of this study is to see if there are differences in urine drainage between two     types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The     difference between the two catheters is that one catheter is vented (the study catheter) and     the other is a standard non-vented catheter. The vented catheter may drain urine better than     a standard non-vented catheter.      If a vented catheter drains the bladder better than a non-vented catheter it may lower the     risk of retained urine in the bladder which could help prevent urinary tract infections.   "
94232|NCT02052661|"     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B     in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in     infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a     single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.   "
94233|NCT02052648|"     In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide     resistant) glioma patients. The overall goal of this study is to provide a foundation for     future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation     and temozolomide, or in combination with vaccine therapies.   "
94234|NCT02052635|"     The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in     rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute     coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with     bivalirudin.   "
94235|NCT02052622|"     To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of     submental fat   "
94236|NCT02052609|"     This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827     in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have     completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or     psoriatic erythroderma who have completed the Study 4827-004 (Study 004).   "
94237|NCT02052596|"     The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK     Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine     in adults aged 50 years or older compared to administration of vaccines separately.   "
94238|NCT02052583|"     Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival     ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication     with only a third of survivors . It is due to a series of phenomena involving     microcirculation disorders . Cerebral oximetry is a new technique to evaluate the     microcirculatory status . To this day it is used in cardiovascular surgery at risk of     cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia     and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the     outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of     action seem to change all the phenomena responsible for microcirculatory reperfusion     disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C.     However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.      The hypothesis of this study is that cerebral oximetry value will be different in patients     subjected to two different levels of therapeutic hypothermia in the aftermath of an extra-     hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying     the benefit of this technique.   "
94953|NCT02043262|"     The purpose of this study is to determine whether a special kind of rehabilitation offered to     home-dwelling older adults is effective with regards to functional ability and municipal     costs.   "
94243|NCT02052518|"     This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member,     35 group organization whose goal is to improve the health of children in Hartford, CT. In a     randomized control trial, the primary aim of this study is to test the initial efficacy of a     program of enhanced home visitation with neighborhood and community support to change     maternal behaviors related to infant nutrition (sweetened beverage/juice consumption,     breastfeeding and introduction of solids), parenting skills (establishing routines around     sleep, reading cues for hunger, satiety, television time) and family wellness (improving the     home food environment, enhancing physical activity). The investigators hypothesize that at 12     months of age, infants in the intervention arm will drink less sugar sweetened     beverages/juices, will have ingested solids at an older age, will have been breastfed longer     and more exclusively than infants in the control arm and will have less TV viewing, more     established sleep routines and greater soothability (primary outcomes).   "
94244|NCT02052505|"     The purpose of this study is to investigate the effect of nurse-led medication reviews on the     frequency, type and potential severity of PIP in psychiatric patients   "
94245|NCT02052492|"     Activated macrophages, present in excess during natural inflammatory responses, bear the     potential to kill and eradicate cancer cells. Macrophage activation has been demonstrated to     require the serum-borne vitamin D binding protein (known as Gc protein), as well as B and T     lymphocytes. However, in various cancer patients the Gc protein is deglycosylated by serum     α-N-acetyl galactosaminidase (Nagalase) secreted from cancer cells. This deglycosylated Gc     protein, lacking the N-acetylgalactosamine monosaccharide, cannot be converted to its form of     Macrophage Activating Factor, leading to immunosuppression rather than Macrophage activation     against cancer cells.      Efranat has developed cancer immunotherapy based on Macrophage Activating Factor produced     from natural Gc protein extracted from FDA approved healthy human plasma.      In this phase I study, the treatment is given as Intramuscular, once-weekly injection of     EF-022, for two courses, while each course is comprised of 4 injections.      The investigational treatment is expected to enhance immune response, thereby, improve     patient's well being, quality of life and disease control.      Primary objectives:        1. To determine the safety and tolerability of EF-022 and to define the maximal tolerated          dose (MTD) for potential administration.        2. To identify the Dose Limiting Toxicity (DLT) of EF-022.      Secondary objectives:        1. To determine the 'Recommended Phase 2 Dose' (RP2D) based on MTD data, immunological and          pharmacodynamics markers        2. To explore preliminary efficacy of EF-022 in advanced solid tumors according to the          'Response Evaluation Criteria in the modified Solid Tumors' (RECIST 1.1) and blood          levels of tumor-related markers known to reflect tumor burden.      Exploratory objectives:        1. To assess levels of immune-related factors in peripheral blood (determined by FACS          analysis), reflecting induced immunological activities, including but not limited to,          natural killer (NK), monocytes (M1 and M2) and T cell subpopulations (effector vs          regulatory, CD4+ and CD8+ cells), B cells (CD20), myeloid and dendritic cells etc.        2. To assess the change in serum levels of protein biomarkers in the blood.        3. To immunohistochemically assess and compare tumor derived tissue samples Pre and post          treatment. To analyze the infiltration of different population of cells into the tumor          bed.   "
94337|NCT02051296|"     The investigators are looking at whether peri-operative minocycline will reduce the duration     of pain after minor hand surgery: carpal tunnel release and trigger finger release.      The investigators' hypothesis is that minocycline will reduce post-operative pain.   "
94246|NCT02052479|"     The purpose of this research study is to see if there are differences between     African-American and Caucasian girls with Polycystic Ovary Syndrome (PCOS) in how their     bodies respond to a type of sugar, called glucose, the body's main source of energy. PCOS is     one of the most common endocrine disorders among females. Features can include anovulation     (eggs are not released from the ovaries) resulting in irregular menstrual periods, excessive     amounts of androgenic (male) hormones resulting in acne and hirsutism (excessive hair growth     on the face and body), and polycystic ovaries (small sac-like structures [cysts] on your     ovaries) seen on ultrasound. Girls with PCOS also have higher levels of insulin in their     bodies (called hyperinsulinism) but are not able to use insulin very well (called insulin     resistance) resulting in an increased risk of diabetes. Diabetes is when you have high levels     of glucose (sugar) in your blood. Many studies have looked at how bodies respond to glucose     and have shown that compared to Caucasians, healthy African-Americans produce much more     insulin (hyperinsulinism) but are not able to use it as well (insulin resistance) in     childhood, adolescence, and adulthood. Insulin is a hormone that helps glucose move from the     blood into the muscles for the body to use as energy. PCOS is associated with increased     levels of insulin (hyperinsulinism) and not being able to use it as well (insulin     resistance). So we want to see if there is a difference in insulin production (secretion) and     insulin resistance between African-Americans and Caucasians girls with PCOS. To do this, we     will look at blood glucose and insulin levels in response to giving glucose in     African-American and Caucasian girls who have PCOS. The results of this study may ultimately     help to more effectively target treatment therapy in individuals with PCOS that have     increased insulin secretion and/or increased insulin resistance.   "
94247|NCT02052466|"     The hypothesis is that computer simulated bony impingement of the bone surrounding the     spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional     (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical     scapular notching that develops following reverse total shoulder arthroplasty (TSA).   "
94248|NCT02052453|"     The purpose of this registry is to document incidence of electrical magnetic interference     (EMI), change in programmed parameters or device related events in patients with Pacemakers     (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring     electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol)     will be used.   "
94249|NCT02052440|"     Adult medical/surgical inpatient hospital care is more difficult and more expensive when     complicated by alcohol dependency (AD), especially for patients who develop alcohol     withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol     Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care     for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7)     has important clinical implications and requires pharmacological treatment. At present, there     are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a     GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with     multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol     dependency in preclinical and clinical studies. We propose to examine baclofen in the     prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize     that Baclofen, as compared to placebo, will significantly reduce the number of adult     inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72 hours     after enrollment. Further the investigators hypothesize that Baclofen, as compared to     placebo, will significantly reduce the need for symptom-triggered benzodiazepine     administration during the 72 hours of hospitalization. These hypotheses will be tested in     adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently     placed on the SEWS monitoring and treatment protocol. These patients will be randomized to     baclofen 10mg three times daily vs placebo.   "
94250|NCT02052427|"     This is a prospective, randomized, placebo-controlled, double blind safety and efficacy     clinical trial.   "
94251|NCT02052414|"     To determine Gralise in treating fibromyalgia pain:        -  efficacy        -  safety   "
94252|NCT02052401|"     The purpose of this study is to determine whether a home visit by an Occupational Therapist     is effective in reducing the rehospitalization rates in elderly patients after hospital     discharge.   "
94253|NCT02052388|"     The purpose of this study is to determine the safety and efficacy of three different dosing     regimens of brilacidin compared to daptomycin for the treatment of serious skin infections.     This study will aid in selecting the appropriate dose of brilacidin for later stage studies.   "
94260|NCT02052297|"     This is a methodology study to examine the quantification of GSK2634673F binding in humans,     with the aim of characterising a robust, non-invasive method to quantify the specific binding     signal for the alpha(V)beta6 protein in human tissues. This will be the first time that this     micro-dose ligand is administered to humans. The study will consist of three parts; Part A,     Part B and Part C. Healthy subjects will be recruited into Parts A and B of the study in     order to gain experience with the GSK2634673F positron emission tomography (PET) ligand and     to optimise the scanning procedures prior to administration to IPF patients in Part C.   "
94261|NCT02052284|"     Extremely low birth weight infants have significant water loss through their skin immediately     after birth. This significant fluid loss is because they have large amounts of fluids, have     immature skin and large surface area. Loss of fluids is associated with many complications.     The investigators hypothesize that application of sterile water to the skin of these infants     is associated with decreased fluid requirements in the first week of life , improve skin     integrity and decrease some complications of prematurity.   "
94262|NCT02052271|"     The purpose of this study is to determine whether transcranial cathodal direct current     stimulation (tDCS) delivered over the cerebellum can improve essential tremor.   "
94263|NCT02052258|"     Opiate dependence is a serious problem, and oxytocin has many properties which make it     attractive as a treatment for this type of substance dependence. This experiment will test     the effects of oxytocin on a variety of brain-based processes in patients with opiate     dependence. The investigators hypothesize that intranasal oxytocin in these conditions will     enhance emotional processing and will have beneficial effects on stress responses in     opiate-dependent patients.   "
94264|NCT02052245|"     This study aims for an in-depth characterization of human milk of mothers who delivered     prematurely to decipher differences with milk of mothers who delivered at the expected term,     with a particular focus on milk proteins   "
94265|NCT02052232|"     This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism     during fasting and feeding in healthy older subjects.   "
94266|NCT02052219|"     The purpose of this study is to compare the effect of blisibimod plus standard of care versus     placebo plus standard of care alone on the proportion of subjects achieving improvement in     renal disease parameters.   "
94267|NCT02052206|"     The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in     realization a computer assisted 3D planning compared to conventional 2D planning.   "
94268|NCT02052193|"     The BRAF inhibitors dabrafenib and vemurafenib belong both two a new class of potent     anti-cancer drugs and are highly efficacious in tumors harboring the BRAF V600E mutation.     Both drugs seem to be equally efficacious; however, their toxicity profile seems to differ.     Serious phototoxicity has been observed in ~ 30% of patients treated with vemurafenib and in     ~2 percent of patients treated with dabrafenib. These phototoxic reactions have developed in     spite of informing the patients of this possible adverse event and instructing them to     protect themselves. Manifestation of phototoxic reactions depends on the patient's habits of     exposure and their efforts to protect themselves. The true frequency of photosensitivity can     only be established by systematic photo-testing. In dermatology, standard test procedures     with different UV-wavelengths and dosages have been established and the primary goal of this     study will be to clarify the true rate of photosensitivity by these two BRAF-inhibitors.     Furthermore, systematic experience will be collected how to best protect patients from     phototoxic events. Dabrafenib and Vemurafenib are commercially available and considered     standard of care for BRAF mutant metastatic melanoma in Germany. As the number of patients     will not allow any conclusion with regard to efficacy or safety of vemurafenib, patients     randomized to vemurafenib in part 2 will only remain on study until completion of     phototesting.   "
94269|NCT02052180|"     The purpose of this study is to demonstrate improved pain control and outcomes in wrist     operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use     of the standard local anesthetic, Marcaine.   "
94271|NCT02052154|"     Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in     splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed     by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of     follow-up of 36 months.      The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes     common to the PCV and PPSV vaccines, selected because of their frequency in invasive     infections in adults in France and their potentially reduced susceptibility to penicillin     (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).   "
94272|NCT02052141|"     Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units     and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent     angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).      Secondary Objectives - To assess the safety and tolerability, characterize the     pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose     levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.   "
94273|NCT02052128|"     This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a     phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid     adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER)     formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the     immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After     enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D.     Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid     adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a,     the cohort will be further expanded by up to 19 more patients to a total of 29 patients to     confirm the efficacy and safety profile of onapristone in this selected patient population     (Stage 2b).   "
95751|NCT02032823|"     Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative     primary breast cancer who have completed definitive local treatment and neoadjuvant or     adjuvant chemotherapy   "
94274|NCT02052115|"     Overweight and physically inactive breast cancer survivors are at increased risk of breast     cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight     loss and exercise success include the long term effects such as fatigue, psychological     distress and impaired executive (cognitive) function.      This study will explore the variability in how breast cancer survivors respond to a     behavioral weight loss intervention. The primary objectives include determining the degree to     which success with a behavioral weight loss intervention in overweight breast cancer     survivors is explained by measures of executive function as measured with task performance at     6 and 12 months and associated brain function imaging (fMRI), collected at baseline     only.Additionally, the study is designed to determine the degree to which selected measures     of cancer-related symptoms account for variance in the success of breast cancer survivors at     6 and 12 months following entry into a behavioral weight loss and exercise intervention.   "
94275|NCT02052102|"     The study hopes to determine whether patients with left-sided breast cancer are at an     increased risk of cardiac changes due to radiation to the breast +/- Anthracycline-based     chemotherapy +/- Herceptin and whether a deep inspiration breath hold (DIBH) technique during     radiotherapy treatments would further reduce dosimetric dose to the heart as compared to the     conventional free breathing (FB) technique thus reducing cardiac toxicity as measured by     cardiac MRI using left ventricular end-diastolic volume (LVEDV) as a metric. Bio fluid     samples will also be collected to investigate specific biomarkers of breast cancer: BNP,     PIIINP and CITP   "
94276|NCT02052089|"     The purpose of this study is to find the optimal treatment method for chronic lateral     epicondylosis, and focused on the 'healing mechanism' and 'pain modulation' of degenerated     tendon.The hypothesis is that there will be significant difference between treatment groups     and control group (physiotherapy) and also there will be significant difference among     treatment groups.   "
94286|NCT02051959|"     -  Phantom limb pain (PLP) refers to pain in a limb that has been amputated or          deafferented. Phantom limb pain might be related to brain cortical plastic changes.        -  The purpose of this study is to determine the efficacy of a series of transcranial          direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation          method, in producing long-term reduction of phantom limb pain among amputees who          experience such pain.      This is a Crossover sham control.   "
94357|NCT02051036|"     This study aims to explore the feasibility of moxibustion as a supplementary intervention and     to assess the sample size for verifying the effectiveness and safety of integrative treatment     involving moxibustion compared with conventional treatment for patients with benign prostate     hyperplasia (BPH) accompanying moderate to severe lower urinary tract symptoms (LUTS).   "
94277|NCT02052076|"     In this study we will compare the health effect of two different meal patterns. In one     subjects will consume food according to an 'irregular meal pattern' (3-9 meals/day) and the     other 'regular meal pattern' (6 meals/day) for two weeks. The energy requirement of the     subjects will be calculated to maintain body weight during the study. Participants will be     provided with all the food to be consumed during the study. Initially, subjects will attend a     screening visit in which they will complete questionnaires on medical health, eating habits     and physical activity. Height, weight and waist circumference will be measured at this visit.     Thereafter, subjects will be assigned to a 2-wk period following one of the two     meal-patterns. There will be a 2-week period between the two interventions when subjects will     consume their normal diet and at the end of this, participants will undertake the next meal     pattern. During the two phases participants will be asked to wear an armband, which detects     movement and measures heat loss, to assess their energy expenditure and a blood glucose     monitoring device will be worn for three days. Before and after each 2-week intervention,     subjects will come to the lab and will be given a test drink and blood samples will be     obtained to evaluate the health effects of the meal patterns. Energy expenditure will be     measured by indirect calorimetry. They will then be offered an ad-libitum meal and be asked     to eat until they feel comfortably full. During each of the 2-week periods, participants will     be asked to record their food intake and record their appetite sensations on specific days.   "
94278|NCT02052063|"     The stapled transanal rectal resection (STARR) has recently been recommended for patients     with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall     intussusception.      The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for     endorectal resection of the distal rectum.      This technique significantly improves constipation. However, there are several reports of     new-onset faecal incontinence after STARR and urgency has been identified as the major     side-effect of this procedure.      Although this technique has become an important surgical option in the treatment of     obstructive defaecation syndrome, its impact on continence can be problematic and objective     data about parameters that predict its result are not yet available One study evaluated the     anal function after surgery in 30 patients. In this study, urgency or incontinence was     complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were     noticed in the endoanal exam performed at the follow-up.      No significant difference was observed in anorectal manometry. Even if data are not     statistically significant, resting and squeezing pressures are lower in those patients not     satisfied.      Currently, anal canal pressure measurements using ano-rectal manometry are the most common     means of assessment of sphincter function. Some studies have been looking at the concept of     distending sphincter regions as a better measure of its performance.      The functional lumen imaging probe (FLIP) is a novel technique which has the ability to     provide real-time images of the function of human gastrointestinal sphincter during     distension. This distensibility technique provides an important new way of studying the anal     canal and hence may have a role in testing sphincter competence in patients with disorders     after STARR procedure.      Twenty-eight patients will be enrolled in this study over a period of 36 months.      Preoperative assessment will include        -  clinical examination        -  the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL)          to rate anal incontinence        -  video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal          sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months          after surgery, and will include symptom evaluation (using the same standard          questionnaires for incontinence), clinical examination and investigation using anal          ultrasound and endoFLIP.      If we demonstrate that this surgical technique can cause anal lesions with decreased     sphincter competence, this may lead to a modification of the surgical technique especially in     patients at risk of developing postoperative anal incontinence.   "
94279|NCT02052050|"     The purpose of this study is to determine the effects of physical training program to improve     deep stabilizer muscle in colorectal cancer survivors   "
94280|NCT02052037|"     We propose a prospective, randomized, single-blind controlled crossover study to assess the     effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric     measures, and overall diet quality in adults with Type 2 diabetes.   "
94281|NCT02052024|"     The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause     muscle atrophy in spastic patients. The primary objective is to assess whether there is     statistically significant difference in muscle atrophy between the two groups over a one year     period.   "
94282|NCT02052011|"     The purpose of this study is to determine the effectiveness of Ranolazine for the treatment     chest pain from disease of small vessels of the heart also known as 'microvascular angina'.   "
94376|NCT02050789|"     Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to     debate how best to (re)structure postgraduate medical education.      There is concern that current restrictions may be detrimental to patient care and resident     training. To investigate these issues, the investigators will be conducting a one-year,     prospective randomized trial to examine how flexibility of duty hour requirements affects     patient care when compared to current resident duty hour requirements. Further information     about the study is available on the FIRST Trial website http://www.thefirsttrial.org/.   "
94377|NCT02050776|"     The purpose of this study was to study the effect of stem cell therapy on the course of the     disease in patients with Limb Girdle Muscular Dystrophy.   "
94283|NCT02051998|"     Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in     industrial countries. In the late stages of the disease, neovascular changes or the     development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by     the development of areas of outer retinal atrophy with continuous spread over time that is     corresponded to an visual field defect for the patient. The pathogenesis is still     incompletely understood. Despite the break-through in the treatment of neovascular AMD by     intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is     yet no treatment available to slow down or halt the disease process in GA. We and others have     demonstrated that the total GA area progression shows large differences between patients.     Potential factors influencing differential progression have been intensely studied: While     neither systemic nor genetic factors have been shown to influence GA progression, ocular     characteristics such as GA baseline size or phenotypic features of fundus autofluorescence     (FAF) abnormalities have been identified as risk characteristics for increased GA     progression. While these previous studies have mainly focused on the characterization of     total GA area progression, topographic directional spread has not been analyzed and relevant     predictive markers are yet unknown. There may be large differences in the local GA     progression. The primary objective of this study is to identify specific characteristics, for     the local GA progression. The knowledge of such risk factors may help to better understand     the pathogenesis of GA. The identification of predictive markers will allow for better     prognostic assessment of the individual disease process. The DSGA study is the extension     trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study     (NCT00393692).   "
94284|NCT02051985|"     The purpose of this study is to evaluate the feasibility and the short-term effects of an     early-start aerobic exercise training program on functional capacity, symptoms and     neurohormonal activation in chronic heart failure patients with recent acute hemodynamic     decompensation.   "
94285|NCT02051972|"     The objective of the study is to confirm clinical performance and safety of the Nanostim     leadless cardiac pacemaker system within its intended use and according to its instructions     for use.   "
94306|NCT02051699|"     The purpose of this study is assess the severity of osteoarthritic knee between one-leg and     both-leg standing radiograph in primary OA knee   "
94287|NCT02051946|"     The purpose of this study is to identify whether or not injection of a study drug (ethacrynic     acid) using the investigational Retroject device is able to lower eye pressures in patients     with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than     20/200 and intraocular pressures (IOP) >20mmHg on maximum medical therapy will be asked to     participate in the study. The first five patients will have the Retroject device placed over     their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the     eye for one minute. The second group of patients (3 total) will have the Retroject device     placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The     third group of patients (12 total) will have the Retroject device placed on the eye and then     will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a     balanced salt solution injection. All 20 patients will then return for intraocular pressure     measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the     patients will undergo pre and post intervention corneal endothelial assessments (endothelial     cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include     bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.   "
94288|NCT02051933|"     The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at     the time of surgery for pilon fractures, will improve ankle range-of-motion and     functionality.   "
94289|NCT02051920|"     Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of     myocardial diseases do not exist.      We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by     elastography.      This study will include 30 patients with cardiac disease whose rigidity varies with     underlying disease.      The purpose of this study is to evaluate the stiffness during open heart surgery.   "
94290|NCT02051907|"     The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in     reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by     comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema,     moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects     treated with the Aloe vera Gel (the control group). In addition, a comparison will be made     between subjects' self evaluation in the treatment group versus the control group. Safety     will be determined by the number and severity of Adverse Events Device-Related.   "
94291|NCT02051894|"     1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic     encephalopathy (HIE). Infants with this condition can suffer multiple organ problems. In     particular it can affect how their hearts pump blood around their body thus leading to a poor     blood supply to parts of their body such as the brain. This is known as circulatory failure     and can contribute to poor long term outcomes such as cerebral palsy. To try and prevent     brain damage these infants are treated with total body cooling, however this treatment can     further effect how babies pump blood around the body, but also how drugs which may be used by     in this condition are processed.      In order to assess and treat this condition doctors need to be able to accurately measure the     blood supply in an infant. However there is no agreement on how best to do this. This makes     decisions about when to treat an infant difficult. Sometimes doctors may want to use drugs     such as dobutamine or adrenaline but these drugs are unlicensed in babies.      This study proposes to observe the way babies circulatory problems are treated in babies with     HIE the in the first four days of life. In addition the study will look are two new     measurements of a babies blood supply to see if they are a better measure of when an infant     needs treatment. This will involve an ultrasound scan of the heart and measurement of the     baby's oxygen levels from a probe placed on their hand. The study will also look at how the     drug dobutamine is processed by babies. This will be done from two small extra blood tests.     The aim of the study is to help clinicians refine the identification and treatment of     circulatory failure in babies with HIE.   "
94389|NCT02050620|"     Using an observational prospective design, potential subjects will be identified and screened     for eligibility via medical record review of breast cancer patients scheduled for radiation     therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will be asked to     complete study questionaires prior to the start of radiation therapy and again during the     last week of therapy.   "
94292|NCT02051881|"     Investigating which receptors are involved in nutient sensing of enteroendocrine cells and on     nerve endings, gives further knowledge on the kind of nutrients responsible for the secretion     of gut hormones involved in satiety signalling. So far only little is know about the     distribution of potential nutient sensing receptors along the gastrointestinal tract. The     investigators are interested in the intestinal parts which highly secrete CCK and GLP-1. By     comparing these tissues, it is expected to further elucidate which receptors are important     for satiety signalling in the intestine.      Having this information gives rise to further reseach on how these receptors stimulate the     secretion of gut hormones. Moreover, knowing which receptors are involved in satiety     signalling, gives oppertunity for targeting these receptors to increase satiety and     influencing food intake.      The investigators aim to investigate the distribution of the above mentioned receptors, in     the following referred to as 'nutrient sensing receptors', which have been suggested to be     involved in satiety signalling, throughout the intestinal tract. For these receptors the gene     expression, localisation and protein expression will be determined at different locations.     This will be measured in intestinal mucosal biopsies of two locations in the duodenum, in the     terminal ileum, the ascending colon, the transverse colon and the descending colon.   "
94293|NCT02051868|"     Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy     treatment for patients with inoperable locally recurrent or metastatic disease. The aim of     this phase II study is compare two well known and largely used chemotherapy regimens -     Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will     set a standard of care for this disease and provide useful information for future Phase III     trials.   "
94334|NCT02051335|"     The purpose of this study is to determine whether scopolamine-induced cognitive impairment is     attenuated by the administration of roflumilast in combination with donepezil.   "
94335|NCT02051322|"     Comparison between three modalities of nebulization.   "
94294|NCT02051855|"     Circulatory failure can affect up to 50% of premature infants that are admitted to neonatal     intensive care. This can be because their heart muscle is not developed enough to send blood     to vital organs such as the brain. This can lead to severe short term problems such as kidney     failure and contribute to poor long term development such as cerebral palsy. In addition     babies born too early may need more time to adapt from a circulation that relies on the     placenta in the womb to one that is self sufficient.      Doctors need to be able to accurately measure the blood supply in an infant. However there is     no agreement on how best to do this. This makes decisions about when to treat an infant     difficult. Doctors may use drugs such as dopamine or dobutamine to help a babies circulation.     However these drugs have not been tested properly in babies older than 33 weeks gestation.      This study proposes to observe the way babies older than 33 weeks circulatory problems are     treated in the first three days of life. In addition the study will look at two new     measurements of a babies blood supply to see if they are a better measure of when an infant     needs treatment. This will involve an ultrasound scan of the heart and measurement of the     child's oxygen levels from a probe placed on their hand or leg. The study will also look at     how the drug dobutamine is processed by babies. This will be done from two small extra blood     tests. The aim of the study is to help clinicians refine the identification and treatment of     circulatory failure in premature babies.   "
94295|NCT02051842|"     Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant     systems. This state is frequently associated with chronic diseases like obesity, insulin     resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may     trigger the progression of fatty liver disease, from triglyceride accumulation to     inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative     stress, could be an important therapeutic target to lessen the severity of the disease. Until     now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but     therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic complex     of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can     reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in     alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver diseases share     molecular mechanisms in the generation of oxidative stress, the investigators propose     metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease,     prediabetic patients.   "
94296|NCT02051829|"     Comparison of preoperative screening score for OSA. In a preoperative population, comparison     of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.   "
94297|NCT02051816|"     Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically     ill patients. Procedural complications including failed attempts at intubation, esophageal     intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death     are common in this setting. While there are many important components of successful airway     management in critical illness, the maintenance of adequate arterial hemoglobin saturation     from procedure initiation until endotracheal tube placement is paramount as desaturation is     the most common factor associated with peri-intubation cardiac arrest and death.     Interventions that either shorten the duration of time required for tube placement or prolong     the period before desaturation may be effective in improving outcome. The high rate of     complications and the lack of existing evidence regarding the efficacy of current airway     management techniques in shortening the time to airway establishment or prolonging the time     to desaturation mandates further investigation. The primary hypothesis is that video     laryngoscopy will be superior to direct laryngoscopy in successful first attempt at     endotracheal intubation (defined by confirmed placement of an endotracheal tube in the     trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care     Medicine fellows after controlling for the operator's past number of procedures with the     equipment used. Also, the investigators hypothesize that the provision of apneic oxygenation     during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per     minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until     after completion of the procedure) will result in a higher arterial oxygen saturation nadir     (defined as lowest noninvasive oxygenation saturation value observed between the     administration of sedation and/or neuromuscular blockade and 2 minutes after successfully     secured airway or death) compared to no apneic oxygenation.   "
94298|NCT02051803|"     The long-term goal of this program of research is to develop and disseminate an efficacious     intervention for weight concern that will significantly increase smoking cessation rates     among women. The overall objective of this project is to develop this intervention and modify     it based on piloting and feedback to ensure its feasibility and acceptability. These     objectives will be accomplished by pursuing the following specific aim: 1) develop a     group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a     comparison health education (HE) program and pilot both treatments with three groups of 10     (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).   "
94299|NCT02051790|"     This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation     in the clinic and by expert readers.   "
94300|NCT02051777|"     To investigate the effect of different strategies for managing malnutrition in the community   "
94304|NCT02051725|"     -  Aging is associated with a progressive and generalized deterioration of physiologic          systems and greater incidence of chronic conditions, which ultimately translates into          functional impairment, disability and dependency.        -  Physical activity and exercise have been recognized as key pillars for the management of          chronic diseases in support of medical treatment, and essential to increase physiologic          function, but there is only limited evidence indicating increased physical function,          following exercise interventions. One of the greatest challenges in the science of aging          and exercise is to understand whether and to which extent exercise and active life-style          may postpone the onset of disability and/or reverse physical impairments.        -  Maintenance/improvements of physical function and mobility should be considered as          primary targets for independent living, active engagement in societal challenges, and,          more in general, when promoting active ageing.        -  The aim of this study is to collect preliminary data to identify the feasibility and          sustainability of an active life-style intervention in older adults with reduced          mobility receiving a preventive home visit from the public health care authority.        -  This study will represent the base for a larger phase III parallel group study          implemented in the public health care setting, with the specific aim of improving          physical function and delay the onset of functional impairment in older adults.   "
94305|NCT02051712|"     The aim of the study is I. To assess whether an individualized exercise training program is     superior as compared to usual care with respect to exercise tolerance, II. to assess whether     intervention tools that aim to increase exercise adherence are superior to an individualized     exercise training alone with respect to exercise tolerance and long-term effects, and III. to     identify biomarkers that that may be implemented into novel intervention tools aiming to     increase exercise adherence in patients with chronic heart failure.   "
94307|NCT02051686|"     This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or     hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia     for short-term use to reduce hemorrhage and the need for replacement blood during tooth     extraction. However, it has also been used extensively in severely injured patients after     major trauma and during elective hip and knee replacements. Previous studies indicate TXA may     reduce blood loss and the need for blood transfusions while being safe for use in most     patients. TXA is fairly inexpensive and easy to obtain.      The purpose of this study is to determine if TXA will make surgery in patients with pelvis     and/or hip socket fractures safer and more cost efficient.   "
94308|NCT02051673|"     Four subjects were treated under compassionate use provisions under this study with     facilitating cell therapy (FCRx)   "
94309|NCT02051660|"     Purpose of this randomized controlled trial is to test the efficacy of the individual     psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German     sample of patients with advanced cancer. The interventions aim is to reduce depression and     distress and support psychological well-being.   "
94310|NCT02051647|"     To investigate whether copeptin levels increase upon a psychological stress (i.e. written     examination) and whether copeptin levels measured immediately before the written examination     predict success of the examination.   "
94311|NCT02051634|"     The purpose of this research study is to explore the effects of fermented papaya preparation     (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of     life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot     study on FPP in older adults. If FPP is found to have a beneficial impact on systematic     inflammation in this study population (adults aged 70-100 years old), then this supplement     may be a potential treatment option to combat aging.   "
94312|NCT02051621|"     Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of     choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a     high success rate (5). It has been recognized that patients with typical atrial flutter often     complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the     close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a     question, if both arrhythmias are different forms of a common electrical phenomenon with     atrial fibrillation being the underlying clinical problem (6).   "
94313|NCT02051608|"     Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study     will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer     disease. Participants will be randomized to receive either gantenerumab subcutaneously every     4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if     on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).      A positron emission tomography (PET) imaging substudy will be conducted within the main     study. Eligible participants who provide separate informed consent will undergo PET imaging     scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain     amyloid load over time. The substudy's target sample size is 100 participants in each arm of     the main study.   "
94314|NCT02051595|"     Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely     used antibiotic for surgery in patients with an allergy to penicillin. During cardiac     surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used     and can lower the level of the antibiotic. The purpose of this study is to quantify the     change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified     ultrafiltration.   "
94315|NCT02051582|"     Thirty (30) orthopaedic surgeons from the University of Florida Department of Orthopaedics     and Rehabilitation will be recruited and enrolled in the study to determine whether having a     laser pointed on a fluoroscopy machine can significantly decrease the amount of radiation     exposure as measured while obtaining multiple views during surgery as well as decrease     radiation exposure and time to accomplish the goals of surgery.   "
94413|NCT02050308|"     The purpose of this study is to test the effectiveness of a culturally-tailored     Internet-based program that helps American Indian (AI) tribal college students quit smoking.   "
94316|NCT02051569|"     Rationale: Poor social functioning may contribute to major depressive disorder (MDD). Poor     serotonin function may also contribute to MDD. Recent research suggests that serotonin plays     a role in regulating human social behaviour. Therefore it would be intriguing to investigate     the role of serotonin in regulating the quality of everyday social interactions in a     population at risk for MDD. Human social behaviour can be reliably assessed in everyday life     using Ecological Momentary Assessment (EMA).      Objective: This study aims to investigate how an experimental increase in serotonin     influences social functioning in healthy adults with a first-degree family member diagnosed     with MDD. The primary goal is to investigate the role of serotonin in regulating everyday     social behaviour, measured using EMA. This will be done using oral supplementation with     tryptophan, the amino acid precursor of serotonin. Secondary goals are to determine how this     experimental manipulation influences people's feelings as well as their perceptions of     other's social behaviour following interpersonal events, and social cognitions at the end of     the day. An exploratory goal is to investigate if these effects are moderated by genes     thought to be involved in MDD.      The primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.   "
94317|NCT02051556|"     Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients     with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and     progression.      In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been     reported to be associated with FOG episodes. As the maintenance of gait depends on the     precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral     coordination may impair gait sequence, potentially causing freezing.      Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait     asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may     lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is     triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait.     Aim of the study was to evaluate how the modulation of asymmetry through physical therapy     might improve gait and FOG.   "
94318|NCT02051543|"     Insomnia is a highly prevalent condition and costly national public health problem and a     transdiagnostic risk factor for the development of a number of internalizing/emotional     disorders, as well as associated functional impairment. Interestingly, sleep treatments     appear to reduce anxiety and depression in addition to improving sleep. Given the substantial     individual and societal costs of insomnia and associated mental illness, there is an urgent     need to better understand the mechanism through which sleep treatments improve daytime     symptoms of depression and anxiety in order to enhance the efficacy of sleep treatments and     ultimately prevent the development of depression and anxiety disorders following the onset of     insomnia. Research suggests that sleep disruptions lead to emotional dysregulation, including     increased negative affectivity and decreased positive affectivity. This affective reactivity     may ultimately be related to the development of depression and anxiety. Despite the apparent     link between sleep and emotion regulation, studies have not investigated the influence of     sleep treatment on these affective dimensions. The investigators long term goal is to     increase understanding of the mechanism of action in sleep treatments in relation to changes     in positive and negative valence systems. The investigators immediate objective is to conduct     a pilot study investigating changes in mean levels and day-to-day instability of affective     dimensions following a brief behavioral intervention for insomnia tailored for veterans     (Brief Behavioral Treatment for Insomnia-Military Version. The specific aims include     developing a deeper understanding of the effects of behavioral sleep treatment on positive     and negative valence systems and testing a model in which affective reactivity modulates the     relation between sleep and internalizing symptoms. Both objective and subjective sleep data,     as well as measures of affective states and depression/anxiety symptoms, will be collected     pre and post-treatment in order to examine changes in sleep, affect and daytime symptoms over     the course of treatment and to test a model in which affective changes mediate the relation     between improvements in sleep and improvements in depression and anxiety. The investigators     hypothesize that sleep treatment will improve sleep, daytime symptoms and affective     reactivity and that changes in affect will mediate the relation between sleep and     internalizing symptoms.   "
94319|NCT02051530|"     Rationale: Major depressive disorder (MDD) is a psychiatric disorder whose onset, severity,     and duration are influenced by interpersonal factors. The serotonin system is known to     influence MDD risk. Recent research has suggested that serotonin may also play a role in     regulating social behaviour. Therefore, it would be interesting to study the role of     serotonin in responses to social stimuli in individuals at risk for MDD.      Objective: This project aims to study how changes in serotonin alter interpersonal     functioning in adults with or without a first degree family member diagnosed with MDD. The     primary goal is to investigate the effect of experimentally lowered brain serotonin levels on     empathic accuracy. Secondary goals are to determine how this manipulation influences verbal     and non-verbal communication, cardiovascular function in a social context, and mood. An     exploratory goal is to investigate how these outcomes are related to genes thought to be     involved in MDD.   "
94320|NCT02051517|"     The aim of this study is to expand the understanding of the vitreous, its solute chemistry,     and the normal relationship of that chemistry to the chemistry of the systemic circulation in     humans.      Sample human vitreous from patients undergoing vitrectomy surgery and compare to results of     metabolic chemistry panel from subject.      Allow the research team to extract .2ml sample of the .5ml - 1.0ml vitreous that is normally     extracted during a routine undiluted vitreous biopsy, a standard procedure performed for     various indications. Blood draw for metabolic chemistry panel (1-2 ml).   "
94321|NCT02051504|"     Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a     relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels,     reflecting poor long term glycaemic control. To explain this relationship, the indirect     effect of chronically high blood glucose levels on cardiovascular complications - and hence     on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if     HbA1c could also have a direct impact on aerobic fitness patients with Type 1 diabetes.     Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the     muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might     have deleterious effect on muscle mitochondrial capacity to use O2. The aim of this study is     to assess the effect of Type 1 diabetes and of HbA1c level on muscular oxygen delivery and     use and hence on aerobic fitness.   "
94322|NCT02051491|"     In preterm infants, endotracheal mechanical ventilation is well known to cause various forms     of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as     ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive     ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and     require intubation. A relatively recent mode of NIV is non-invasive high frequency     ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can be     ventilated effectively. However, its efficacy in comparison with other existing modes of NIV     remains unknown due to lack of appropriate studies. The investigators hypothesize that NIHFV     is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) in     preterm infants in preventing intubation following NCPAP failure.   "
94324|NCT02051465|"     Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in     2010 and worldwide has become the third most common cancer and second leading cause of cancer     related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and     endoscopic removal of the polyps prevents development of colon cancer.      Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal     resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically     difficult to perform, labor intensive, time consuming and carries higher risks of     complications (bleeding, perforations, etc.). The purpose of this study is to determine the     effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is     hypothesized that the use of this modified colonic overtube will simplify colonoscopic     removal of difficult polyps, decrease the time needed to complete the procedure and decrease     the rate of complications post endoscopic removal of large and flat colonic.   "
94325|NCT02051452|"     The aim of this study is to investigate whether methylphenidate (Ritalin) can actively induce     emergence from general anesthesia in patients having a pancreaticoduodenectomy (Whipple     procedure), a pancreatectomy, or a prostatectomy.   "
94326|NCT02051439|"     This study was designed to compare the party balloon assisted Valsalva with the conventional     Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence     duplex examination.   "
94327|NCT02051426|"     The efficacy of compounds having agonistic activity at the glycine site associated with the     N-methyl-D-aspartate receptor (NMDAR) is presently assessed in psychiatric disorders. In     contrast to NMDAR antagonists, the neuropsychiatric effects of NMDAR agonists in the healthy     human organism are not known. The investigators studied neuropsychiatric and neurochemical     effects of the NMDAR-glycine site obligatory co-agonist D-serine (DSR) in healthy subjects     using a randomized, controlled crossover challenge design including a baseline assessment day     and two treatment administration days (DSR and placebo in randomized order). Thirty-five     subjects aged 23-29 years participated in the study and received a 2.1g orally administered     DSR dose. The main outcome measures were the changes in scores of mood-related Visual     Analogue Scale (VAS), Continuous Performance Test - Identical Pairs (CPT-IP), and Rey     Auditory Verbal Learning Test (RAVLT).   "
94328|NCT02051413|"     Predictive factors and biomarkers of response to antidepressants in major depressive disorder     are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and     desensitize serotonergic and dopaminergic receptors. The study hypothesis is that     Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants     in major depressive disorder. In a controlled prospective open naturalistic monocentric     3-month study, 60 patients with a major depressive disorder requiring a treatment with     venlafaxine will be included and assessed before treatment, 1 month and 3 months     post-treatment. 20 controlled healthy subjects matched for age and gender will also be     assessed. The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral     Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be     assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.   "
94329|NCT02051400|"     The purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is equal     or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for novice     users in a simulated airway manikin.   "
94330|NCT02051387|"     Despite recent advances in the understanding and treatment of schizophrenia, this devastating     disease still affects one percent of world's population. Existing antipsychotics reduce     psychotic symptoms but are generally not very effective in treating so called negative     symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the     disease. Furthermore, a significant portion of patients is refractory to all current     treatments. Therefore new treatment strategies are needed.      Several studies suggest a strong association between schizophrenia and the endocannabinoid     system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of     the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is     known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient -     cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one     of the most effective modern antipsychotics, amisulpride, but it induced significantly less     side effects.      In this phase I safety study, the investigators will evaluate the pharmacokinetics,     pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new     tablet pharmaceutical preparation of cannabidiol in healthy volunteers.   "
94331|NCT02051374|"     Lumbar Degenerative Spondylolisthesis (LDS) is a slippage of one vertebra over another caused     by degeneration of facet joints, ligaments and intervertebral discs. Most patients suffer     from symptoms related to spinal stenosis, such as radiating pain to the lower extremities,     and typically increased pain in the lower limbs when walking upright and decreased when     bending forward.      There is a moderate grade of evidence for whether patients will achieve better outcome after     surgery when decompression is followed by fusion. In theory, fusion following decompression     should give more stability to the operated level, thus less pain and less progression of the     olisthesis. On the other hand, fusion procedures, in general, are associated with more severe     complications and postoperative mortality than decompression alone.      In summary, there is still insufficient evidence for performing fusion in addition to     decompression for patients with LDS. The investigators are planning a trial where the main     aim is to detect whether the intervention-related difference in outcome between decompression     alone (DA) and decompression followed by fusion with instrumentation (DF) is large enough to     justify the use of the fusion procedure. The proposed trial is a randomized, controlled,     multicentre, non- inferiority trial with two parallel groups, with 15 participating Norwegian     hospitals. The main analysis will be performed 2 years after surgery with long-term follow-up     planned at 5 and 10 years postoperatively.   "
94421|NCT02050204|"     Although the prevalence of family-friendly policies in US workplaces has increased     dramatically, few have been studied using scientifically sound designs. To address this, the     NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN     designed and conducted multiple pilot and feasibility studies. For Phase 2, the WFHN     implemented an innovative intervention based on Phase I pilot studies that is designed to     increase family-supportive supervisor behaviors and employee control over work, and to     evaluate the intervention using a group randomized experimental design. Customized     interventions were performed separately in workplaces of two separate corporate partners.   "
94332|NCT02051361|"     Coronary artery stents, particularly drug-eluting stents (DES), are used in the majority of     patients who undergo percutaneous coronary intervention (PCI) to improve symptoms in patients     with obstructive coronary artery disease. They function both to prevent abrupt closure of the     stented artery soon after the procedure as well as to lower the need for repeat     revascularization compared to balloon angioplasty alone . Stent restenosis and stent     thrombosis are potential complications of coronary artery stenting; their incidence is     highest in the first year after PCI. Stent restenosis, which occurs more frequently with bare     metal stents (BMS) than DES, may occasionally present as an acute myocardial infarction (MI).     Stent thrombosis is an uncommon but serious complication that often presents as death and is     almost always accompanied by MI, usually with ST-segment elevation. Patients are commonly     treated with dual antiplatelet therapy (DAPT) for the recommended duration for the particular     stent. DAPT (aspirin plus platelet P2Y12 receptor blocker) and significantly lowers the risk     of stent thrombosis.   "
94333|NCT02051348|"     Helicobator pylori (H. pylori) is a bacteria which survives in the lining of the stomach. An     estimated 50% of the world's population is infected with H. pylori. Developing economies,     such as in Southeast Asia, the Indian subcontinent and Latin America, have prevalence rates     of as high as 90%.      H. pylori infection often goes undiagnosed, as many sufferers do not experience any adverse     symptoms. Infection with H. pylori is described as not a disease in itself but a condition     that affects the relative risk of developing various clinical disorders of the upper     gastrointestinal tract.' Clinically relevant symptoms could include peptic ulcer, melena or     secondary conditions such as iron deficiency anemia or vitamin B12 deficiency.      There is evidence that probiotics can be beneficial for those with gastrointestinal diseases.     Pylopass contains the probiotic strain Lactobacillus reuteri, which was selected for its     anti-H. pylori characteristics and in clinical trials has shown to result in a reduction in     urease breath test values in subjects with H. pylori.      The objective of this study is to evaluate the ability of Pylopass to reduce H. pylori load     in subjects who are H. pylori positive.   "
94338|NCT02051283|"     HCC is classified as keratin (K) 19 positive or K19 negative. K19 is a biliary/hepatic     progenitor cell (HPC) marker only expressed in a subset of HCC with poor prognosis and high     risk of early recurrence after treatment; particularly in radio-frequency ablation (RFA).     These patients consequently show worse survival compared to patients with K19 negative HCC.      A recent publication has shown the value of pretreatment biopsy with K19 staining and     suggests that the role of routine biopsies in potentially curable HCC should be reconsidered.      However, currently, pretreatment biopsies are rarely performed in the diagnosis of HCC due to     the excellent performance of magnetic resonance imaging (MRI) in detection, diagnosis and     staging of cirrhotic livers.      Previous publications have indicated imaging patterns that may be associated with worse     prognostic tumoral parameters.      If MRI determined imaging parameters could indeed provide a surrogate marker for presence of     K19 and/or microvascular invasion as potential important prognostic factors in RFA of HCC,     these imaging parameters may thus hold prognostic information towards RFA treatment and     possibly predict treatment outcome. .      The purpose of the retrospective study is thus to evaluate MRI determined imaging parameters     at pretreatment MRI for their predictive value towards outcome (disease free survival) of     radio-frequency ablation for hepatocellular carcinoma.      If successful, pretreatment MRI parameters may be used for selecting patient with high risk     of unfavorable outcome after RFA and select the patients for more aggressive treatment such     as surgical resection or upfront transplantation.   "
94339|NCT02051270|"     One important issue in older adults with cognitive problems is the higher risk of fall due to     decreased motor function and balance. The objective of this study is to evaluate the     repercussions of mild cognitive impairment in balance in elderly.   "
94340|NCT02051257|"     This phase I trial studies the highest possible dose of memory enriched T cells that can be     given following standard stem cell transplant before unmanageable side effects are seen in     patients with B-cell non-Hodgkin lymphoma that has returned after previous treatment. A T     cell is a type of immune cell that can recognize and kill abnormal cells of the body. Memory     enriched T cells will be made from a patient's own T cells that are genetically modified in a     laboratory. This means that the T cells are changed by inserting additional pieces of     deoxyribonucleic acid (genetic material) into the cell to make it recognize and kill lymphoma     cells. Memory enriched T cells may kill the cells that are not killed by stem cell transplant     and may lower the chances of the cancer recurring.   "
94341|NCT02051244|"     The purpose of this study is to determine whether by measuring changes in the thickness of     the retinal nerve fibre layer (the photosensitive layer at the back of the eye) you could     predict if someone would develop Alzheimer's disease in the future. The measurement is made     by OCT (ocular coherence tomography), a noninvasive and relatively inexpensive test that uses     light waves to scan the back of the eye.   "
94514|NCT02048995|"     Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still     lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and     limited, and clinical decision making is less refined. Currently, the investigators are     investigating the effects of midday bright light therapy for the treatment of bipolar     depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar     Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a     possible biological mechanism which might explain response to light treatment in depressed     bipolar patients.   "
94342|NCT02051231|"     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide     and is caused most commonly by poor uterine muscle tone after delivery. The first line agent     used in the prevention and treatment of PPH is oxytocin, which acts by binding with oxytocin     receptors (OTR) found on myometrial cells to cause uterine contraction.      Women who require augmentation of labour with oxytocin because of inadequate labour     progression are at increased risk of PPH because they have received intravenous oxytocin     which exposes the uterus (and OTR) to doses greater than would normally be found without     medical intervention. This exposure results in OTR desensitization and decreased uterine     sensitivity to oxytocin which may lead to the use of much higher doses of oxytocin (up to 9x)     or other agents for preventing and treating PPH with the potential for causing serious     drug-related morbidity or fatality to the mother.      Currently, in women who have failed labour augmentation and need to have a Cesarean delivery,     it is not known if it would be beneficial to wait a certain period of time after     discontinuing intravenous oxytocin before proceeding with the operation. The goal of the     waiting time would be to allow the OTRs to recover and resensitize the uterus to the effects     of oxytocin to avoid the need for high doses or additional uterus-contracting agents.      Our hypothesis is that there will be a positive correlation between the magnitude of recovery     of the myometrium's response to oxytocin and the time elapsed from the desensitizing oxytocin     pretreatment (simulated labour augmentation).   "
94343|NCT02051218|"     The aim of the trial is to test the hypothesis that the benefit of denosumab is maintained if     administered only every 12 weeks as compared to every 4 weeks.   "
94344|NCT02051205|"     The purpose of the Parkinson's disease Registry (PDR) is to develop a nation-wide database of     persons with Parkinson's disease (PD) in Taiwan.   "
94345|NCT02051192|"     Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that     incorporate exposure therapy useful for treatment of anxiety disorders among typically     developing children. Although a large amount of data demonstrate the effectiveness of of BT     and CBT approaches for treating anxious youth, there is a gap in the literature for the     effectiveness of these approaches for children under the age of seven. Evidence increasingly     suggests that family factors such as accommodation and parenting style contribute     significantly to the presence of anxiety symptoms as well as treatment outcomes, particularly     in young children. These findings stress the importance of using a treatment approach in     which parents are directly involved in education, parent training, and generalization of     treatment effects. Therefore, this study aims to evaluate a new treatment program, parent-led     behavioral treatment, for children ages 3 to 7 years of age who have a principal anxiety     disorder diagnosis.   "
94358|NCT02051023|"     Hypothesis: Fluorometholone (FML) 0.1% eyedrops topically applied 4 times a day for 22 days     is more efficient than artificial tears (Liquifilm) in dry eye disease (DED) and ameliorates     the worsening of the disease after exposure to an adverse controlled environment.   "
94346|NCT02051179|"     The aim of this prospective, randomized clinical trial was to assess the effectiveness of     repair of localized clinical defects of amalgam restorations that were initially scheduled     for replacement of restorations. A cohort of 20 patients with 40 (Class I and Class II)     amalgam restorations, that presented one or more clinical features that deviated from the     ideal (Bravo or Charlie) according to USPHS criteria, were randomly assigned to either, the     repair or replacement group: A: repair n= 19 and B: replacement n=21. Two examiners who had     calibration exercised evaluated the restorations at baseline and ten years after according to     seven parameters: marginal occlusal adaptation, anatomic form, surface roughness, marginal     staining, contact, secondary caries, and luster   "
94347|NCT02051166|"     The purpose of this study is observe clinical practice including glucocorticoids treatment in     AECOPD in China.   "
94348|NCT02051153|"     This project aims to investigate the effect of modafinil on motivation, creativity, cognitive     performance, and subjective wellbeing in healthy participants. The main task for this     research project is to address how this novel stimulant acutely influences motivation,     divergent and convergent thinking, cognitive performance and subjective wellbeing in     non-sleep deprived healthy young adults.This is a randomised between-subjects parallel group     design study.      Based on the hypothesis that psychostimulants might enhance creativity through the increase     in of dopamine and executive planning in healthy adults , we predict that healthy individuals     who are in the modafinil condition will perform better in the motivation, creativity, and the     cognitive performance tasks. Furthermore, based on the evidence that modafinil increases     dopamine in the nucleus accumbens, putamen and the caudate, we expect specific subjective     well-being and pleasure enhancement associated with modafinil use in healthy young adults.   "
94349|NCT02051140|"     This study is being conducted to assess the effect of dietary strawberry supplementation on     cognition and mobility in older adults. It is hypothesized that plant compounds, present in     strawberries, may improve cognition and mobility by protecting against oxidative stress and     inflammation.   "
94350|NCT02051127|"     One of the biggest challenges of today is the high stress levels among employees in companies     and organizations. Physical exercise may be an effective preventive measure for     stress-related problems. This relatively simple and inexpensive action is believed to be     important for increasing and maintaining work ability and reduce the cost of stress-related     ill health in the workplace.      The aim is to investigate how regular physical exercise affects the individual's ability to     mentally and physiologically cope with stress. Acute stress physiological responses are     measured before and after a 6 -month intervention, where 100 untrained individuals are     randomized to either regular physical exercise or a control group.      The hypothesis is that exercise leads to lesser activation of the individual's stress     physiological systems and to an efficient physiological protection system. Mental ability to     handle stress is also studied as well as possible effects on the brain's cognitive functions.     From a work perspective, cognitive impairment due to high exposure to stress is a major     problem leading to substantial costs in businesses and organizations as a result of reduced     performance and production.      We believe that physical activity can alter and mitigate individual stress reactions. This     study brings new knowledge that can contribute to increased motivation to prioritize physical     activity in everyday life. The study could also provide evidence for businesses and     organizations of the benefits of engaging in interventions and fitness initiatives to     facilitate/enable increased physical activity in daily life for its employees. With an aging     population, we are expected to work longer, which poses a challenge as the ability to manage     stress and maintain cognitive abilities decline with age. For older employees, regular     physical activity could be an important factor directly affecting the prospects for a     sustainable working life.   "
94351|NCT02051114|"     Longitudinal study of patients with rheumatoid arthritis comparing measures of disease     activity with blood samples.   "
94352|NCT02051101|"     The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain,     collect biopsy samples and blood samples to characterize exosomes and metabolites from Port     Wine Stain.   "
94515|NCT02048982|"     The purpose of this study is to test whether physicians change their use of non-recommended     tests, procedures, or medications more in response to evidence based-guidelines, price     information, or an individual patient's story.   "
94353|NCT02051088|"     Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to     stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest     pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk     of amputation, to exercise-induced pain (intermittent claudication), limiting the patients     daily activities. Invasive treatments are often indicated to prevent amputations and to     alleviate symptoms. More than two thirds of these procedures are presently performed with     endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without     stent implantation).      In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents,     DES) reduce restenosis and improve clinical results for the majority of patients. Drug     eluting balloons (DEB) are a promising alternative, but there is still little evidence that     DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing     these new technologies in PAD have been reported in a few studies.      In this trial, we test the hypothesis that drug eluting (DE) technology is superior to     conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when     applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular     lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each     defined by the severity of peripheral arterial disease. Patients with critical limb ischemia     are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to     SWEDEPAD 2.   "
94354|NCT02051075|"     Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually     based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However,     fertilization rate with this method is still lower compared with ICSI using motile sperm. One     of the reasons for that is the immotile sperm inability to activate the oocyte Our research     hypothesis is that better fertilization rate can be accomplished in these cases by combining     PXN sperm activation with Ca ionophore oocyte activation.   "
94355|NCT02051062|"     The purpose of this study is to verify the pediatric dosing recommendations for BAT® in     pediatric patients that are treated with BAT® due to a confirmed or suspected case of     botulism. One 5 mL blood sample will be obtained within 24 hours post BAT® administration.     Study BT-011 will be run concurrently with the BAT patient registry (BT-010).   "
94356|NCT02051049|"     The purpose of this study is to assess the long-term safety follow-up of patients having been     treated with HepaStem.   "
94359|NCT02051010|"     The study will follow a descriptive design involving a survey. Data collection will involve     paper based questionnaires. The questionnaires have been developed in conjunction with breast     cancer support groups associated with the Irish Cancer Society and patients.   "
94361|NCT02050984|"     Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of     at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions     such as diabetes. A variety of studies showed that it cause significant weight loss, recovery     from diabetes and improvement in cardiovascular risk factors, such as blood pressure. The     recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with co morbidities     is a candidate for bariatric surgery. However, the patients with diabetes in Chinese has     lower BMI than that in west country. Therefore, this research is designed to observe whether     bariatric surgery reduce blood pressure in patients with diabetes and relatively lower BMI.   "
94362|NCT02050971|"     The purpose of this study is to test the safety and effectiveness of a whole own (autologous)     umbilical cord blood transfusion in the first 5 days after birth if the baby is born     premature <34 weeks and developed anemia of prematurity.   "
94363|NCT02050958|"     Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the     study drug) which it is proposed will have less of the side effects than are currently     reported with standard prescription strength Ibuprofen.      This study will compare the study drug to an already marketed formulation of prescription     strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body     and also by performing a specialist procedure called an endoscopy (or more specifically a     gastroscopy). The safety and tolerability of the study drug will also be assessed.      The study will involve approximately 44 healthy male and female subjects. Subjects will be     randomly assigned to receive either the study drug or reference product for 8 days. On Day 1,     subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will     receive 800 mg ibuprofen three times a day.   "
94364|NCT02050945|"     The purpose of the present project is to investigate the physiological effects of two     different types of exercise training in COPD patients. The patients will be examined before,     during and after 8 weeks of training to evaluate the effect of different types of skeletal     muscle stimulation on health related quality of life, 6 min walking distance, flow mediated     dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity,     fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will     test the hypothesis that:      Resistance training is superior to endurance training in patients with COPD   "
94516|NCT02048969|"     The purpose of this study is to test feasibility of measuring flumazenil-induced changes in     cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of     hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a     double-blind, placebo-controlled, randomized, cross-over design.   "
95814|NCT02032004|"     The primary objective of this study is to determine whether transendocardial delivery of     allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of     chronic heart failure due to LV systolic dysfunction.   "
94365|NCT02050932|"     Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron     deficiency anemia. However, absorption of OIS is often low and response is variable. To     overcome this, large doses are given but this may reduce compliance due to gastric     irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum     hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte     iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose     but the duration of the increase is uncertain: In a recent study conducted in our laboratory     it has been found to last approx. 24 h. Also, there are few data on how the increase in SHep     determines the absorption of further doses of oral iron. Is there a threshold SHep at which     subsequent iron absorption is sharply reduced? Better understanding of this relationship     would be valuable to design more effective and safer OIS regimens.      Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect     hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron     supplement dosages given at different times of the day (Study 2).      Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic     subjects will be excluded from the study. Thirty two subjects will be included with serum     ferritin <20 µg/L, C-reactive protein <5 mg/L and Hemoglobin >117 g/L. Subjects will be     randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day 1     (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron isotopes     54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will be     collected to monitor sHep and iron status markers.      Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for     better understanding of the iron-hepcidin relationship and this may enable design of more     effective OIS regimens.   "
94366|NCT02050919|"     This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation     therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue     sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride     and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation     therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination     chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue     sarcoma.   "
94367|NCT02050906|"     This randomized pilot clinical trial studies intensive diet and exercise or standard of care     in improving physical function and quality of life in patients with prostate cancer     undergoing androgen deprivation therapy. Diet and exercise may help improve physical function     and quality of life in prostate cancer patients. It is not yet known whether intensive diet     and exercise is more effective than standard of care in improving physical function and     quality of life in patients with prostate cancer undergoing androgen deprivation therapy.   "
94368|NCT02050893|"     Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid     responsiveness has significance in volume resuscitation for septic shock patients. As the     sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness     for the pharmacological effect of venodilation. However, the hypothesis has not been     certified clinically. In this research, the investigators aim to test the hypothesis that     Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock     patients.   "
94369|NCT02050880|"     The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance     to the RS-3000, assess the crossed precision of each study device and to assess the     transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000     Advance.   "
94437|NCT02049996|"     The purpose of this study is to to determine if there is a difference in patient related     outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse     repair compared to robotic-assisted repair.      We hypothesize that pain and quality of life following robotic-assisted repair will be     similar to that following vaginal reconstruction, when performed in conjunction with vaginal     hysterectomy.   "
94370|NCT02050867|"     Physicians and nurses working in non-mental health settings require tools to guide them in     recognizing patients at risk. While screening children and adolescents is emerging as a     priority of the Joint Commission, there are currently no suicide screening instruments     designed specifically for assessing suicide risk in a pediatric inpatient medical population.     Recently, our study team developed the Ask Suicide-Screening Questions (ASQ), a 4-item     suicide risk screening instrument with excellent sensitivity, specificity, and negative     predictive value for use in pediatric emergency departments (Protocol #08-M-N070). However,     use of the ASQ in an inpatient medical setting has not been tested. The aim of this study is     to determine the utility of the ASQ among pediatric medical inpatients in children s     hospitals. While most inpatients will not be at imminent risk for suicide, we hypothesize     that the ASQ will capture a number of patients who screen positive and are not only at risk     for suicidal behavior in the future, but are also experiencing significant emotional distress     and therefore warrant further psychiatric evaluation and follow-up treatment. This will be a     multisite study, comprised of medically ill inpatients at three non-NIH affiliated sites     (Children s National Medical Center, Boston Children s Hospital, and Nationwide Children s     Hospital), with a total sample size of 600 (200 per site). We will administer several short     measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief depression     screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all eligible     inpatients aged 10-21 years. The ultimate goal of this project is to provide non-mental     health clinicians with a brief, accurate assessment tool for detecting risk of suicide in     pediatric medical inpatients and in turn, connecting those in need with mental health     services. After validating the ASQ with pediatric medical inpatients, we will then examine     the practical implications of nurses administering the ASQ as standard of care during the     admission process on a pediatric medical inpatient unit. Future studies will focus on     validating the ASQ in non-English speaking patients, addressing a critical gap in suicide     prevention research. In addition, examining the long-term clinical impact of screening     general medical patients for suicide risk with the ASQ and linking those in need with mental     health services and/or other interventions will be important next steps.      Please note: This is a multi-site study that is being conducted at three non-NIH sites, all     children s hospitals, two of which have already received IRB approval (Boston Children s     Hospital and Children s National Medical Center) and one which is in the process of     submission (Nationwide Children s Hospital). No NIH patients will be enrolled at the Clinical     Center. Consent and patient data collection will take place on inpatient medical units at     those three sites; data will be sent to NIMH, and stored and analyzed here.   "
94371|NCT02050854|"     The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects     with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are     currently on treatment with oral aripiprazole.   "
94372|NCT02050841|"     The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas     in pediatric patients who require replacement of multiple coagulation factors. Replacement of     multiple coagulation factors in pediatric patients with acquired deficiencies due to liver     disease and in pediatric patients requiring cardiac surgery or liver surgery.   "
94373|NCT02050828|"     The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as     daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab     for 3 months in patients with diabetic macular edema.   "
94374|NCT02050815|"     This study is a phase I, multi-center, open-label, single oral dose, parallel group study to     assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy     subjects with normal hepatic function. Subjects will be assigned by hepatic function defined     by elevation of serum total bilirubin and serum AST as determined at the screening and     baseline visits. The study population will be healthy male and postmenopausal or sterile     female subjects who meet all of the inclusion and none of the exclusion criteria. A minimum     of 24 evaluable subjects (6 subjects per group) will be enrolled. The groups are: Group     1-healthy volunteers, Group 2-Mild hepatic impairment, Group 3-Moderate hepatic impairment     and Group 4-Severe hepatic impairment. Once approved for enrollment, participants will be     confined to the facility for 5 days, given a single dose of MEK162 and monitored for safety     assessments, labs and PK will be assessed.   "
94378|NCT02050763|"     Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few     interventions combining HIV and IPV prevention have been evaluated and none has significantly     decreased both outcomes.      A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters     (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone     (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by     Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard     of care HIV services alone.      Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study between     2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV and HIV     incidence. Secondary outcomes included past year intimate partner rape/forced sex, number of     total and extra-marital sex partners, alcohol use surrounding sex, condom use, discussion     about condom use, partner's disclosure of HIV status and respondent's disclosure of HIV     status. Analysis was by intention-to-treat. Modified Poisson regression was used to estimate     prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and secondary     outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of HIV     acquisition per 100 person years (py).      Our study had three research aims and related hypotheses.      Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization     from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the     impact of RHSP community services alone.      Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in     intervention vs. control arms.      Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in     intervention vs. control arms.      Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors     among men and women compared to the impact of RHSP community services alone.      Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the     intervention vs. control arms.      Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the     impact of RHSP community services alone.      Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.   "
94379|NCT02050750|"     This is an exploratory, translational, non-interventional and multi-centre biobank. The aim     of the development of such a biobank is to identify potential biomarkers that are indicative     of disease relapse.   "
94380|NCT02050737|"     This is an exploratory, translational, non-interventional and multi-centre clinical study.   "
94381|NCT02050724|"     Title ThoHSpEkt      Study Design Pilot Study concerning the technical operative methods and a phase II study     concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a     new indication)      Location Kantonsspital St.Gallen      Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules     with the help of free-hand SPECT.      Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be     operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is     not possible a switch to minithoracotomy is performed.      Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided     surgery      Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal)      Rational for patient number 10 patients for each group are enough to prove the feasibility,     to manage difficulties and to record complications      Duration approximately 24 months.   "
94438|NCT02049983|"     The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and     Performance in Laparoscopy.   "
94439|NCT02049970|"     the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during     supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine     providing prolonged analgesia after surgery.   "
94440|NCT02049957|"     This is a phase 1b/2 study of the safety and efficacy of MLN0128 in combination with     exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal     growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer that has     progressed on treatment with everolimus in combination with exemestane or fulvestrant.   "
94382|NCT02050711|"     The effect of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease     (COPD) has been based on systemic outcome measures, however, little is known about the     effectiveness of this intervention on patients' lung function. The forced expiratory volume     in one second (FEV1), despite of being the gold standard for assessing lung function in COPD,     is poorly responsive to pulmonary rehabilitation. Thus, an objective and responsive outcome     measure to assess the effect of pulmonary rehabilitation on lung function is needed.      Computerized respiratory sounds have been found to be a more sensitive indicator, detecting     and characterizing the severity of respiratory diseases before any other measure, however its     potential to detect changes after pulmonary rehabilitation has never been explored.     Therefore, this study aims to assess the effects of pulmonary rehabilitation on the     characteristics of computerized respiratory sounds in patients with COPD.      A randomized controlled study with one group undergoing pulmonary rehabilitation (n=25) and     other group receiving standard care (n=25) will be conducted. The pulmonary rehabilitation     program will included exercise training (3*week) and psychoeducation (1*week).      Computerized respiratory sounds, lung function, exercise capacity, quadriceps muscle     strength, health-related quality of life and health services use will be assessed in both     groups, at baseline, immediately post-intervention and at follow-ups (3 and 6 months after     PR).      Descriptive and inferential statistics will be used.      It is expected that significant changes occur on the characteristics of computerized     respiratory sounds in patients enrolled in the pulmonary rehabilitation group, in comparison     with patients receiving standard care. Thus, computerized respiratory sounds could provide a     simple, objective and non-invasive measure to assess lung function changes after pulmonary     rehabilitation.   "
94383|NCT02050698|"     Fifth metatarsal avulsion fractures are common and can usually be treated conservatively.     Symptomatic care consisting of protected weightbearing in a hard-soled shoe, air-cast walking     boot, or below-knee walking cast have been successful. Several papers reported that early     rehabilitation may decrease ankle stiffness, muscle and bone atrophy, and aids in early     return to activities. However, early motion of the ankle joint may have the risk of     displacement of the fifth metatarsal avulsion fractures. However, studies using hard-sole     shoe for protected weightbearing and allowing motion of the ankle joint had successful     results. Clapper et al. compared the results of hard-soled shoe and walking cast for a fifth     metatarsal avulsion fracture and reported that all avulsion fractures healed uneventfully and     that the results were similar between the two. However, this was not a randomized controlled     trial.      Devices such as air-cast walking boot, plaster slipper, or Jone's dressing can also be used     for the treatment. However, we decided to compare results of hard-soled shoe and short leg     walking cast for the treatment of a fifth metatarsal avulsion fracture.      We hypothesized that the 100mm visual analogue scale (VAS) assessed on 6 months after a fifth     metatarsal avulsion fracture treated with protected weightbearing in a hard-soled shoe is not     inferior to protected weightbearing in a short leg walking cast but is superior to short leg     walking cast with respect to time to return to normal daily life and patient's satisfaction.   "
94384|NCT02050685|"     Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the     results of a polysomnography (PSG). The different screening score studied are: STOP-BANG,     DES-OSA, P-SAP and OSA50.   "
94385|NCT02050672|"     In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI)     treatment is able to improve IVF outcomes.      In particular, retrieved oocytes will be randomly divided in two groups, one group will be     inseminated with MI treated semen while the other will be inseminated with untreated semen.   "
94386|NCT02050659|"     In patients with gastric cancer, traditionally a complete omentectomy is performed as part of     a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases     operation time significantly, especially in laparoscopic procedures. Patients remain more     vulnerable for peritoneal infections and intestinal adhesions following omentectomy.     Furthermore one can debate whether a complete omentectomy is indicated from an oncologic     viewpoint. In the present study we prospectively evaluated the presence of tumor load in the     greater omentum of patients with potentially curative gastric cancer.   "
94387|NCT02050646|"     The purpose of this study is to determine whether a salt restriction diet improves immune     parameters in patients with autoimmune hepatitis.   "
94388|NCT02050633|"     The objective of the protocol is to pursue the long-term follow-up of a large cohort of     severe traumatic brain injury patients. This outcome is to be described in terms of activity,     participation, quality of life, socio-professional outcome, economical consequences and     impact on caregivers, and in relation to health care provision.      Secondary objectives are to measure the impact on outcome of several predictive factors; to     evaluate evolution of patients since the last (four-year) evaluation.   "
94390|NCT02050607|"     Obesity is associated with changes in the composition and metabolic function of the gut     microbiota. Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or     fecal infusion, refers to the process of injecting a liquid suspension of stool from a     healthy donor into the gastrointestinal (GI) tract of a patient to cure a specific disease.     However, since the recently established concept of human gut microbiome and its significant     role in health and disease has caught on in the medical scientific world, this procedure has     gained a great pathophysiological strength, meaning not only the simple infusion of stools,     but the transplantation of a healthy gut microbiota in a patient with a disrupted one. In a     recent dutch experience, FMT from lean donors was able to increase the insulin sensitivity in     patients with metabolic syndrome.      Our primary aim is to evaluate if FMT from lean healthy donors, in association to lifestyle     changes, is able to reduce insulin-resistance more than lifestyle changes alone in patients     with metabolic syndrome.      All the patients with metabolic syndrome will receive lifestyle counselling (1400     kilocalories diet and physical activity encouragement), than will be randomized to FMT from     healthy lean donors by upper endoscopy (group A) or no treatment (group B)   "
94391|NCT02050594|"     The primary objective of the protocol is to identify and describe observed adverse events     (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study     period   "
94392|NCT02050581|"     In this prospective and retrospective chart review, investigators will evaluate the response     rates and duration of response for patients with relapsed and refractory idiopathic     thrombocytopenic purpura (ITP) who have been treated with rituximab and repeated courses of     dexamethasone. Investigators will also evaluate observed toxicities of the combination, and     characteristics associated with response.   "
94464|NCT02049645|"     Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy     subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is     hypothesized that sniff dogs may be used as a tool in screening cancer patients in health     examination. Trained dogs will sniff serum from participants who are attending the annual     health examination to identify potential or high risk subjects, and the results will be     compared with the outcome of the traditional health examination, and the high risk subjects     will be followed periodically for at least five years.   "
94393|NCT02050568|"     Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure     reflectometry (UPR), for measurements of pressure and cross-sectional area in the female     urethra. UPR has been able to separate continent women from women with stress urinary     incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The     method stands alone in its field.      9.5 % of all women undergo genital prolapse surgery during their lives (genital prolapse is     characterized by a portion of the vaginal canal protruding from the opening of the vagina).     However, 10-30 % of these women develop SUI after surgery, while approximately 40 % with     preoperative SUI actually experience an improvement in their condition. Efforts have been     made to predict the likelihood of a patient having SUI after genital prolapse surgery;     however the tests have shown disappointing positive and negative predictive values.      A mid-urethral sling is gold standard for treatment of SUI and to avoid SUI after genital     prolapse surgery, some clinics choose to treat all their patients with a sling,     simultaneously. However, not all patients with SUI require surgery and the sling is     associated with some risks, such as bleeding and bladder injury. There is no international     consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery.     Thus, there is great need for knowledge and know-how regarding the mechanism of continence in     women with genital prolapse, before and after surgery.      The hypothesis is that UPR may be used to uncover the changes in the female urethra before     and after genital prolapse surgery, revealing significant differences in the parameters in     women who develop SUI after surgery. UPR may become an important tool in the preoperative     assessment, helping clinicians give better information and guidance to their patients.   "
94394|NCT02050555|"     This study is designed to evaluate the effect of koji-extracted beverage fermented with     Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.   "
94395|NCT02050542|"     The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected     by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get     no lower rate of cancer detection than those obtained by 12 systematic transrectal     ultrasound-guided biopsies of the prostate.   "
94396|NCT02050529|"     Severe Hypertension in pregnancy demands urgent treatment because of high mortality &     morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden     hypotension and tachycardia. Labetalol because of combined α and β blocking effects lacks     these side effects. Cochrane systematic review could include only three trials of comparison     of hydralazine with labetalol. All three had sample size ranging from 20-60 obstetric,     including 19-30 pregnant women. This review could not conclude about comparative effects due     to insufficient data and suggested that further trials should compare hydralazine with     nifedipine or labetalol, and to report severe persistent hypertension and adverse     feto-maternal effects.      OBJECTIVES:1) To compare efficacy of labetalol versus hydralazine for control of pregnancy     related severe hypertension.2) To compare adverse maternal and fetal effects of the two     drugs.      3) Furthermore, to develop risk assessment model for response to treatment, in terms of     patient and disease characteristics.      STUDY DESIGN: Randomized controlled trial.      SETTING & DURATION OF STUDY: Gynaecology Unit I, Civil hospital Karachi over a period of 1     year.      METHODS: Total one hundred eighty patients with, severe hypertension(systolic blood     pressure(SBP)≥160 and/or diastolic blood pressure(DBP) ≥110 mm Hg) at greater than 28 weeks     of pregnancy or upto72 hours after delivery, will be enrolled. In each group 90 patients will     be allocated to intravenous labetalol or hydralazine using simple random sampling. Primary     outcome measures will be lowering of SBP to <160 mm Hg and DBP <110 mm Hg and severe     persistent hypertension. In addition maternal hypotension, tachycardia, bradycardia, adverse     effect on fetal heart, still birth and neonatal bradycardia will be measured.      EXPECTED OUTCOME: Efficacy and side effects of labetalol against hydralazine, in our     population will be determined. Assessment model for response to treatment, will help in     choosing a drug with better efficacy and minimal side effect profile for different patient     and disease profiles.   "
94397|NCT02050516|"     Does group culture using micro-well group culture dishes improve human blastocyst development     compared to single embryo culture?   "
94398|NCT02050503|"     An open-label, non-randomized study to assess the titration, safety and efficacy of     intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain     secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid     therapy for chronic pain.      Study objectives include assessment of breakthrough pain episodes related with food intake in     patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck     tumors   "
94399|NCT02050490|"     This study investigates whether the implementation of a symptom diary for reporting and     communicating chemotherapy-related symptoms improves symptom care and decreases symptom     burden in adult patients treated with chemotherapy.      The hypothesis is studied using a before-and-after design. First, symptom care and symptom     burden will be observed in a sample of patients not being offered a symptom diary. Next, the     symptom diary will be implemented at the participating hospital and symptom care and symptom     burden will now be observed in a new sample of chemotherapy patients.   "
94400|NCT02050477|"     Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a     prospective study of 100 patients   "
94517|NCT02048956|"     Knee osteoarthritis is a common condition characterized by pain and functional disability in     older people. Prevalence increases with age and is more frequent in older women. The aim of     this study was to assess the effects of an 8-weeks hydrotherapy training with elastic bands     on pain and functional disability in old people with knee osteoarthritis.   "
94401|NCT02050464|"     The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a four-year     IT-project funded through the European Union (EU). The project consortium involves a total of     21 universities and industrial partners from 10 European countries. The project delivers the     first patient-specific predictive models for early differential diagnosis of dementia and     their evolution. An integrated clinical decision support platform will be validated / tested     by access to a dozen databases of international cross-sectional and longitudinal studies. As     a part of the VPH-DARE@IT project, a new prospective cohort will be collected in Kuopio. This     prospective cohort will be used to test further the modeling approaches and tools developed     by using the retrospective databases.   "
94402|NCT02050451|"     The current study is designed to assess the impact of an enriched oral nutritional shake     (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove     a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a     segment of intestine is the standard of care for invasive bladder cancer. This operation has     a high complication rate and several studies have shown that this may be directly related to     poor nutrition.      The investigators believe that patients who consume an enriched nutritional shake before and     after surgery will improve their nutrition status and experience fewer complications, shorter     length of stay and less readmissions compared to those who do not.      Patients who are scheduled to undergo elective radical cystectomy will be eligible for     enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group     will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery     and the other will be offered a daily over-the-counter multivitamin for the same period of     time. The investigators will follow both groups for up to 30 days after their surgery and     compare clinical outcomes such as: complication rates, length of stay, readmission rates and     mortality as well as measure serum markers of nutrition status and assess changes in body     composition.   "
94405|NCT02050412|"     Measurement of skin reactivity of cat dander samples obtained by different methods.      Subjects will be assessed for the study by of a conventional skin prick test with a positive     (histamine), a positive (standardized cat dander extract) and a negative allergen control (a     diluent) if they fulfil all other in- and exclusion criteria, too.      A screening prick test will be performed in order to confirm positivity (cat dander allergy).      A scratch test will be performed in participants after a positive screening prick test, in     order to measure skin reactivity to cat dander, originating of three different body areas of     the cat. For this purpose, a small amount of cat fur in solution with distilled water will be     placed onto the volar aspect of both forearms after the skin has been scratched with a     scratch lancet. The distilled water in which the cat hair was solved before will serve as     negative control.      This procedure will be repeated with fur of the three different areas of the cat, always     using triplicates (nine samples per cat).      From each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).   "
94406|NCT02050399|"     Coronary artery disease (CAD) and diabetes mellitus (DM) may promote alterations in heart     responses during exercise or postural maneuver. Thus, the purpose of this study is to observe     the influence of different postures (supine, seated and standing) and different percentages     (15, 30, 45 and 60%) of the maximum voluntary contraction (MVC) of handgrip in the responses     of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean     arterial pressure (MAP), cardiac output (CO), stroke volume (SV) and peripheral vascular     resistance (PVR) in coronary patients with and without type 2 diabetes.   "
94407|NCT02050386|"     This is a study designed to look at how arousal levels in the brain change with age and how     these changes influence thinking, vision, hearing and physical function in people of advanced     age.   "
94408|NCT02050373|"     The aim of the study was to evaluate the effect of low-level laser therapy (LLLT) on the     severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory     cytokines, metalloproteinases and growth factors) levels in saliva and blood of hematopoietic     stem cell transplantation (HSCT) patients.   "
94409|NCT02050360|"     The purpose of this study is to determine whether on-demand sildenafil is effective in the     treatment of Raynaud's phenomenon.   "
94410|NCT02050347|"     Patients have a type of lymph gland cancer called Non-Hodgkin Lymphoma (NHL), acute     lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) (these diseases will be     referred to as lymphoma or leukemia). The lymphoma or leukemia has come back or has not     gone away after treatment (including the best treatment known for these cancers). Because     there is no standard treatment for this cancer at this time, subjects are asked to volunteer     to be in a gene transfer research study using special immune cells.      The body has different ways of fighting infection and disease. No one way seems perfect for     fighting cancers. This research study combines two different ways of fighting disease,     antibodies and T cells, hoping that they will work together. Both antibodies and T cells have     been used to treat patients with cancers; they have shown promise, but have not been strong     enough to cure most patients.      T cells can kill tumor cells but there normally are not enough of them to kill all the tumor     cells. Some researchers have taken T cells from a person's blood, grown more of them in the     laboratory and then given them back to the person.      The antibody used in this study is called anti-CD19. This antibody sticks to cancer cells     because of a substance on the outside of these cells called CD19. CD19 antibodies have been     used to treat people with lymphoma and leukemia. For this study, the CD19 antibody has been     changed so that instead of floating free in the blood it is now joined to the T cells. When     an antibody is joined to a T cell in this way it is called a chimeric receptor. The T     lymphocytes will also contain CD28, which stimulates T cells and makes them last longer.      Treatment with CD19/CD28 chimeric receptor-T cells has had activity against lymphoma and     leukemia when the cells are made from the patients affected by these diseases. In this study,     investigators are going to see if this treatment works even better when they make these cells     from a healthy stem cell donor. If investigators are not able to collect blood from the stem     cell donor, they will collect blood from the subject to make the CD19/CD28 chimeric     receptor-T cells.      These CD19/CD28 chimeric receptor T cells are investigational products not approved by the     FDA.      The purpose of this study is to find the biggest dose of chimeric T Cells that is safe, to     see how long T cells with this chimeric receptor last, to learn what the side effects are,     and to see whether this therapy might help people with lymphoma or leukemia after a stem cell     transplantation from a donor.   "
94411|NCT02050334|"     The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in     increasing doses. How long the drug remains in the body will also be calculated.   "
94412|NCT02050321|"     We propose to conduct a phase 2 study to assess whether the addition of acitretin to     vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC)     development, a known side effect of vemurafenib therapy, in patients with advanced melanoma.     Further, we seek a preliminary assessment as to whether the addition of acitretin to     vemurafenib enhances the clinical efficacy of this anti-melanoma agent.   "
94414|NCT02050295|"     Injecting local anesthetic to anesthetize a nerve or group of nerves (a 'nerve block') is an     effective way to eliminate pain during and after surgery. There are instances when it would     be beneficial to the patient for the nerve block to be resolved quickly rather than waiting     for it to naturally wear off. For example, a sciatic nerve block that freezes the lower leg     and foot typically takes over 18 hours to resolve on its own, and both the surgeon and     patient prefer to have motor function before discharge. The investigators wish to perform a     randomized, controlled trial to determine if infusion of a solution such as saline to 'wash     out' the nerve block after surgery can allow the patient to be pain-free while still being     able to move their leg and foot.   "
94415|NCT02050282|"     Breathlessness is a dangerous symptom. Preliminary data from national and regional Danish     databases show, that patients with shortness of breath in the ambulance have a very high     mortality. Breathlessness can be caused by many different conditions - but heart diseases and     lung diseases are dominant. The mortality is especially high in patients with breathlessness     caused by heart disease.      Distinguishing these different causes of breathlessness is a classical, often difficult,     discipline in medicine. Visitation and guidance of treatment in patients with breathlessness     in the prehospital setting relies on medical history and physical examination and as a     consequence prehospital treatment for breathlessness is often non-specific. The use of     heart-failure specific biomarkers may improve prehospital visitation and treatment of     patients with breathlessness.      We hypothesize, that        1. Supplementing the routine examination by prehospital anesthesiologist with measurement          of a biomarker for heart failure increases the proportion of patients with severe          shortness of breath caused by heart disease triaged directly to department of cardiology        2. This strategy does not increase the proportion of patients with severe shortness of          breath caused by non-heart disease triaged directly to department of cardiology   "
94416|NCT02050269|"     The objective of this study is to assess the feasibility of estimating the clearance of     iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal     function in the intensive care unit through analysis of rich iohexol plasma kinetics.   "
94466|NCT02049619|"     The purpose of this study is to determine whether pharyngeal packs can reduce nausea and     vomiting in patients undergoing orthognathic surgery.   "
94417|NCT02050256|"     Background: Optimizing the basic palliative care has been shown beneficial to patients in     end-of-life care, the general practitioner (GP) having a pivotal role in the health care     system, providing comprehensive and continued medical care.      The aim of the study is to investigate the effect of a complex intervention in general     practice on GPs' awareness of and confidence in providing end-of-life care.      Method: A follow-up study among 404 general practices in Central Denmark Region. The     participating general practices will get the opportunity to receive education in palliative     care and access to an electronic support, which provides advice on palliative care and an     overview of the palliative population in each medical practice. The education and the support     will focus on patients suffering from either metastatic cancer or chronic obstructive     pulmonary disease (GOLD stage 4).      The end-of-life care delivered by the GPs to their deceased patients will be analysed, based     on questionnaires to GPs and register data related to the deceased patients before and after     the intervention, .      Primary outcomes: Place of death of deceased patients, time spent at home, and number of     hospital admissions in the last three months of the patients' lives.      Secondary outcomes: Number and kinds of contacts between GPs and patients, use of relevant     medicine and of the 'Safety Box'. Finally GPs' confidence concerning palliative care will be     assessed in questionnaires.   "
94418|NCT02050243|"     Surgery is the cornerstone treatment of most pediatric CNS tumors, including astrocytomas,     ependymomas, medulloblastomas, and many other pathologies.      In most pediatric CNS tumors, the aim of surgery is maximal tumor resection, while preserving     neurological function. Extent of tumor residual has been shown to be a major prognostic     factor for progression free survival (PFS), and survival in several malignant and low-grade     tumors such as medulloblastomas, ependymomas, and astrocytic tumors.      5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of     various cancers. Following oral admission, during surgery, the tumor tissue is illuminated by     blue light. Tumor cells tend to metabolize 5-ALA to a porphyrin named protoporhyrin IX     (PpIX). PpIX reacts with the blue light and emits a pinky color (- fluorescence). This     enables the surgeon to better identify tumor cells and perform a more extensive resection.      Over recent years, many studies have proven the efficacy using 5-ALA for resecting various     intracranial and spinal tumors, thus achieving a better tumor control.      In the suggested study, we propose using the same technique for various pediatric central     nervous system tumors.      We will focus on the correlation between various pathologies and the fluorescence, trying to     deduce the role of 5-ALA in resection of specific pathologies.      Also, we will study the safety of 5-ALA use in the pediatric population.   "
94419|NCT02050230|"     Transfusion of stored blood has been associated with increased pulmonary vascular resistance     in lambs. The investigators hypothesize that transfusion of one unit of red blood cells     stored under standard conditions in intensive care patients will increase pulmonary arterial     pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh     red blood cells.   "
94420|NCT02050217|"     Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the     machine applies positive pressure throughout inspiration in proportion to the electrical     activity of the diaphragm (EAdi), Because ventilator functioning and cycling are under     control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance     patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance.     Among different interfaces, the pediatric helmet is better tolerated than facial or nasal     mask, thus requiring less sedation and allowing more prolonged ventilatory assistance     (5-6).To date, no data exist on the use of NAVA in infants during noninvasive ventilation.     The aim of this physiological study is to compare patient-ventilator interaction in infants     receiving NIV by NAVA and Pressure Support Ventilation (PSV) with helmet.   "
94518|NCT02048943|"     This phase I trial studies the highest and safest doses of dovitinib lactate, paclitaxel     albumin-stabilized nanoparticle formulation, and gemcitabine hydrochloride when given     together. Dovitinib lactate disrupts the activity of fibroblast growth factor receptors and     reduces cancer growth and spread. Gemcitabine hydrochloride and paclitaxel albumin-stabilized     nanoparticle formulation are anti-cancer drugs for treating many cancer types.   "
94422|NCT02050191|"     This study supports the development of a diabetes prevention and control community web     portal. The portal will feature an innovative personalized impediment profiling tool and     reward program. The program, Nutrition Navigation on-Line Edge, or NnoLEDGE, will be used     by community consortiums for weight loss and diabetic health interventions within their     communities.      The Specific Aims are:        1. Recruitment of local community organizations to participate as a community health          consortium        2. Development of a comprehensive community health web portal consisting of a web portal,          impediment profiler, community toolbox, and rewards system        3. Final evaluation of the system with regard to participants' attitudes and perceptions of          using NnoLEDGE as a tool for weight control and diabetes prevention to determine          feasibility.   "
94423|NCT02050178|"     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and     PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 will be     administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel (125 mg/m2) and     gemcitabine (1000 mg/m2) will be administered IV on Days 1, 8, and 15 of each cycle. The     planned dose levels of OMP-54F28 are 3.5 mg/kg and 7.0 mg/kg.   "
94424|NCT02050165|"     Proposed is a parallel-design randomized controlled trial to compare the effects of consuming     two types of snacks on a daily basis for a 12-week period on health outcomes, diet quality,     and self-reported satiety in a group of overweight adults. The types of snacks to be studied     are KIND snack bars with almonds and typical American snack foods).   "
94425|NCT02050152|"     The investigators are conducting a study to investigate the amnestic effects of 2 different     concentrations of nitrous oxide in children before induction of anesthesia in a prospective     double-blinded placebo controlled study.   "
94467|NCT02049606|"     This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet     and CENATONE tablet in the treatment of osteoarthritis of the knee.   "
95091|NCT02041442|"     The hypothesis is that the intrinsic electrical activity of the urinary bladder in response     to filling is detectable and can be mapped. This is a pilot study to evaluate the feasibility     of using cardiac electrical mapping catheters to measure bladder voltage in patients at the     time of routine urodynamic and cystoscopic evaluation.   "
94426|NCT02050139|"     Over the last decades, peritoneal dialysis has grown worldwide to become one of the most     common modalities of renal replacement therapy, particularly in developing or newly     industrialized countries, such as India, China, Korea, Turkey, Malaysia, Mexico and Brazil.     Peritoneal dialysis has been associated with an initial survival benefit compared to     hemodialysis, although this advantage becomes less apparent over time, likely due to the     progressive loss of residual renal function and the development of pathological alterations     of peritoneum . Recent results suggest that an antioxidant therapy by N-acetyl-cysteine oral     supplementation may improve residual renal function in peritoneal dialysis patients. This     finding may have major clinical relevance, as preserving residual renal function in     peritoneal dialysis patients has been associated with improved survival . Aim of the present     randomized, double-blind, crossover study is to confirm the preliminary evidence of the     beneficial effects of antioxidant agents on residual renal function by using the     L-enantiomeric form of cysteine in 10 prevalent peritoneal dialysis patients with residual     diuresis.   "
94427|NCT02050126|"     Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted     in 1 site.      Each subject will receive three treatments on one area that was randomly chosen. The other     area will be left untreated and will serve as a control.      The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide     laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated     scar side.   "
94428|NCT02050113|"     The purpose of this study is to evaluate the safety and efficacy of custom made devices,     Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular     grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms or     thoracoabdominal aneurysms who (1) have anatomy not suitable for endovascular repair using     grafts currently marketed in the United States,(2) are deemed unsafe to wait the required     time necessary for commercial endograft manufacturing, and (3) are at high risk for open     surgical repair.   "
94429|NCT02050100|"     The study goal is to collect blood samples from individuals at risk for lung cancer in order     to identify protein markers for diagnosis of lung cancer in the Chinese population.   "
94430|NCT02050087|"     The study is a prospective randomized controlled non-inferiority trial where we elucidate the     role of postoperative immobilization after arthroscopic rotator cuff repair.   "
94431|NCT02050074|"     Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug     metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).   "
94432|NCT02050061|"     Chronic venous insufficiency (CVI) is a common disease affecting mainly lower limbs leading     to significant impact on the quality of life. There is no study, to our knowledge, has     attempted to evaluate the impact of compression stockings on all patients with CVI. Our aim     is to estimate the prevalence of CVI in Qassim Region and to test the effectiveness of     compression stockings.   "
94433|NCT02050048|"     The purpose of this study is to examine whether giving large amounts of intravenous (IV)     fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis     (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious     complication of ERCP. Typically, a small amount of IV fluids are given during this procedure     (~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will     reduce the risk of PEP.   "
94447|NCT02049866|"     The purpose of this research study is to evaluate antiresorptive therapy with denosumab     (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal     women with idiopathic osteoporosis.      Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial,     A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in     Premenopausal Women (NCT01440803) may be eligible to participate in the current study, a     36-month open-label pilot study of denosumab (Prolia®, 60mg SC every 6 months).      The goals of the study are to estimate the effects of denosumab on central and peripheral, as     well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data     to inform the design of a future randomized study. This study presents the first opportunity     to study the effects of denosumab after TPTD in this unique and severely affected group of     young women.      Funding Source - FDA OOPD   "
94519|NCT02048930|"     The aim of this study is to compare the clinical effectiveness and cost-effectiveness of the     Easyhaler® (EH) device and other DPI devices commonly used in the UK in a UK primary care     asthma population of patients aged 6 to 80 years.   "
94435|NCT02050022|"     Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease that is characterized     by loss of lung function, leading to breathlessness, poor quality of life, loss in     productivity, and increased mortality. The World Health Organization estimates that COPD will     be the third leading cause of death worldwide by 2020, accounting for more than 7 million     deaths annually. COPD patients frequently experience 'lung attacks', during which     breathlessness, coughing, and sputum production dramatically increase, leading to urgent     office visits, emergency admissions and hospitalizations. Lung attacks reduce patient quality     of life and cost the Canadian health care system nearly $4 billion dollars each year in     direct and indirect costs. Lung attacks can be effectively managed if they are identified and     treated early, but symptoms of a lung attack often overlap with those of other common     conditions such as heart failure, pneumonia and even influenza. Because there are no tests     that can separate lung attacks from these conditions, doctors struggle to accurately diagnose     lung attacks at an early stage when drugs are most effective. This can lead to a delayed or     even incorrect diagnosis and inappropriate treatment. This research will address this     critical need. Our goal is to improve COPD patient care by developing new blood tests that     will help identify patients who are in the early stages of a lung attack. Doctors will be     able to use these tests to treat lung attacks at earlier stages than is currently possible.     These blood tests will enable doctors to personalize management of COPD to meet the needs of     the individual patient.      Hypothesis: New biomarker blood tests can be used to better identify and manage patients with     COPD.   "
94436|NCT02050009|"     This phase I trial studies the side effects and best way to give metformin hydrochloride,     carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or     primary peritoneal cancer. Drugs used in chemotherapy, such as metformin hydrochloride,     carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing.   "
94441|NCT02049944|"     The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of     cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the     current established dosing of 2 grams. The tissue and serum concentration values, when using     an increased prophylactic dose, can then be compared to our pilot study assays in hopes of     determining an optimal dosing for the obese and morbidly obese populations undergoing     cesarean delivery.      A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial     Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of     antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the     obese and extremely obese populations. The purpose of this research study is to evaluate     whether in increased dose of antibiotics given before cesarean delivery (3 grams of     cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum     (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an     effect on the levels of antibiotics in the tissues (a group of similar cells).      This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index     (BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of     prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC.     Researchers hope to enroll a total of 35 women overall.   "
94442|NCT02049931|"     The treatment outcomes in the treatment without brace would be non-inferior to those in use     of rigid or soft brace.   "
94443|NCT02049918|"     Collect de-identified, residual samples to support a clinical trial. Samples may be     prospectively or retrospectively collected. Overall Study Objective Obtain clinical     performance data to characterize clinical performance of the Respiratory Viral Panel on the     GenMark Sample-to-Answer Platform.   "
94444|NCT02049905|"     The purpose of this study is to determine the efficacy and safety of aldoxorubicin in     subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.   "
94445|NCT02049892|"     Does having a large diameter metal on polyethylene total hip replacement increase metal ion     release. Larger metal heads are thought to have increased torsional forces on the trunion     which would like release more metal ions. Increased metal ion levels have been associated     with adverse local tissue reactions. Are there any differences comparing these groups to a     dual mobility type total hip replacement.   "
94446|NCT02049879|"     The objective of this study was to objectively measure daily physical activity and     spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of     life, before and six weeks after an intra-articular corticosteroids injection in patients     suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis     were recruited. The intra-articular corticosteroid injection was given at the end of the     second week. Physical activity was objectively measured by an accelerometer worn by the     participants for eight weeks. In addition, the Western Ontario and McMaster Universities     Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials     were completed every two weeks to assess symptoms, quality of life and spatiotemporal     parameters of gait.   "
95648|NCT02034175|"     The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for     diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology     in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes     respiration (CSR).   "
94448|NCT02049853|"     Acute dyspnea is a common chief complaint of patients presenting to the emergency department.     Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high     as 10% during hospitalization and up to 30% within 6 months of follow-up. The Triple A     Initiative Study is designed to improve the coordination of care for patients with acute     dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the coordination of     care starting at the EMS level including point-of-care testing of the cardiac biomarker     NTproBNP will support preclinical and clinical diagnostic clarification. Treatment deriving     from earlier diagnostic clarification will reduce length of stay in the hospital, treatment     costs and improve patient's outcome.   "
94449|NCT02049840|"     This is a prospective, post-market, single arm, multicenter study comparing Baseline data to     the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence   "
94450|NCT02049827|"     Kidney transplantation is the treatment of choice for end stage renal disease (ESRD)     improving the quantity and quality of life for dialysis patients. Although prolongation of     graft survival in the short term by preventing the release is observed by immunosuppression     (IS) powerful, the longer-term survival has not improved . Indeed, the IS can not only have a     direct deleterious effect on the kidney transplant , but too weak IS can promote rejection,     and too strong, promote the emergence of a viral disease polyomavirus BK ( BKV ) . BK     nephropathy (BKVAN ) virus is accompanied by an irreversible impairment of the renal function     , leading to a loss of the graft followed by a premature return to dialysis in at least 50 %     of cases. Plasma BKV reactivation was observed mainly during the first year of     transplantation in 15% of patients and complications annually BKVAN concern about 5 % of     recipients . Currently , treatment options are very limited , only the decrease in IS shows a     partially effective when care is early . There is no specific antiviral effective treatment     of this disease . In addition, there is no way to predict which patients will develop BKV     reactivation BKVAN despite lower tax.      The diagnosis of interstitial nephritis BKV based on the detection of viral DNA by PCR and     plasma is confirmed by histological analysis of renal tissue . Plasma quantitative PCR (     qPCR) to measure the progression of the disease and therapeutic efficacy. Control of BKV     viremia is the direct antiviral immune response quality based primarily on a very effective     anti- T lymphocyte activity BKV reflection. In this context, the inhibition of lymphocyte     activation induced by IS blocks the establishment of T-cell responses anti- BKV in most     transplant, a very low presence of T lymphocytes is generally observed in these patients     anti- BKV (LYT - BKV) blood .      Our preliminary studies have validated in vitro a sensitive test to measure the functionality     of blood LYT - BKV. This test is used to evaluate the concentration and functionality of LYT     - BKV present in small volume of blood by measuring their specific proliferation after     stimulation with peptide cocktails BKV. Proof of concept of the feasibility of this test was     established on a small series of samples and highlights significant differences in lymphocyte     anti-BKV different patients.      Put to good use during the post-transplant follow-up, this type of test can provide the     clinician with valuable data to assess the quality of anti- BKV T response compared to the     intensity and type of IS treatment. Early identification of patients at risk of reactivation     of BKV, or at risk of BKVAN if BKV viremia observed , would adapt the therapeutic response     and monitoring arrangements at the fair. The objective of this project is to conduct a     feasibility study to assess the relevance of post-transplant monitoring of anti- BKV T     response of BKV viremic patients during the first year post- transplant. Immunological data     will be analyzed in relation to virological data and bioclinical data.   "
94451|NCT02049814|"     The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose     combined with Metformin in patients with type 2 diabetes mellitus (T2DM) by evaluating levels     of glycosylated hemoglobin.   "
94452|NCT02049801|"     This phase I trial studies the MEK inhibitor MEK162 to see if it is safe in patients when     combined with idarubicin and cytarabine. MEK inhibitor MEK162 may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162,     cytarabine, and idarubicin may be an effective treatment for acute myeloid leukemia.   "
94453|NCT02049788|"     The objective of this study is to compare the effectiveness of a low-GI diet program and a     standard counseling program in the treatment of obese Thai children.   "
94454|NCT02049775|"     Ulcerative colitis (UC) is a chronic inflammatory condition of unknown aetiology,     characterized by a diffuse confluent mucosal inflammation of the colon starting from the     rectum with a relapsing and remitting course. Conventional endoscopy was thought to be a     reliable parameter of disease activity, but microscopic inflammation can persist despite     normal mucosal findings. Histologically detectable inflammation is associated with a greater     risk of subsequent relapse. A flare in UC activity is difficult to predict, but a simple,     easily measured biological marker of relapse would be important in guiding the most     appropriate therapy.      Recent technological advances in fiber optics, light sources, detectors, and molecular     biology have stimulated development of numerous optical methods that promise to significantly     improve our ability to evaluate human epithelium in vivo. These methods, collectively termed     optical biopsy, are nondestructive in situ assays of mucosal histopathology using light     that can provide instantaneous tissue assessment. Narrow band imaging (NBI) is a novel     technique that enhances the diagnostic capability of endoscopes in characterising tissues by     using filters in a redgreenblue (RGB) sequential illumination system. This results in     improved mucosal contrast and detail.      UC always involves the distal colon and activity is usually greatest in rectosigmoid area.     This makes evaluation of the rectum and sigmoid an attractive marker in patients with UC.     Unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be     affected by systemic disease and would be acceptable test for patients and physicians.      We plan to evaluate THE rectosigmoid mucosa in patients with UC by flexible endoscope using     both white light and NBI endoscopy. These patients will be followed by for one year or until     they relapse, whichever comes first. The aim of our study is to develop endoscopic biomarkers     to predict relapse in acute and quiescent UC.   "
94455|NCT02049762|"     Thus far, no study has evaluated the impact on aspirin in addition to the newer and more     potent P2Y12 inhibitors, among ACS patients and current guidelines recommend dual     anti-platelet therapy consisting of aspirin and a novel P2Y12 inhibitor in this population.      Objective The investigators goal is to examine the effect of aspirin in addition to new     anti-platelet agent (ticagrelor\prasugrel) on platelet reactivity in comparison with placebo,     among ACS patients treated percutaneously.      Design The proposed study is a randomized-controlled, double blind trial, conducted among ACS     patients treated percutaneously. Eligible patients will recruited during hospitalization due     to ACS after percutaneous coronary intervention (PCI), and randomization by envelopes on 1:1     basis will take place a month after the index event, at a follow-up visit at the cardiac     clinic.      Platelet function and Endothelial function tests will be taken a month after the index event,     and at a 2 weeks periods following aspirin/placebo therapy, cross-over and return to     open-label aspirin.      End-points platelet function tests will be compared between aspirin and placebo therapy and     before and after the cross-over.   "
94456|NCT02049749|"     The purpose of this research study is to learn whether or not a brief parenting program     called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help     improve behavior problems in children who are 2-6 years old.   "
94457|NCT02049736|"     Chronic kidney disease (CKD) and chronic viral hepatitis due to hepatitis B virus (HBV) are     both major public health problems. Treatment of chronic HBV infection in CKD patients,     however, is not well defined because of insufficient data from clinical trials. Telbivudine     is a new antiviral that provides effective and sustained viral suppression in patients with     compensated chronic hepatitis B infection. Unlike other nucleotide and nucleoside analogues,     renal toxicity is uncommon in telbivudine, and dosage adjustment is not required in patients     with mild renal impairment. We propose to conduct an open-label single-arm study to evaluate     the effect of telbivudine on renal function and proteinuria in patients with chronic HBV     infection and mild-to-moderate renal impairment. Twenty patients with chronic HBV infection     and chronic kidney disease (estimated glomerular filtration rate 15 to 60 ml/min) will be     recruited. They will be treated with telbivudine, with the dosage adjusted according to thei     renal function, for 5 years. Serum HBV DNA, proteinuria, renal function, and urinary     inflammatory markers will be monitored.   "
94458|NCT02049723|"     -  1. Research topic: How much do patients with GERD know about their own disease in Korea?          (multicenter survey)        -  2. Questionnaires for multicenter survey:             1. Questionnaire 1 - include items for basic characteristics of participant patients             2. Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health               Services Research 2008;8:236 (Prof. Jorgen Urnes)        -  3. Subjects: patients with GERD in secondary or tertiary hospital        -  4. Participant institutes: GERD club members, The Korean Society of          Neurogastroenterology and Motility   "
94459|NCT02049710|"     The purpose of this study is to measure the effects of an interactive video on adolescent     risky behaviors and outcomes, with one video intended to reduce teen pregnancies and the     other intended to reduce automobile accidents.   "
94460|NCT02049697|"     The purpose of this study is to investigate the absorption, metabolic pathways and excretion     of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg     (0.5 mg/mL solution) of 14C-JNJ-39823277.   "
94461|NCT02049684|"     Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of     the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears     can be managed with arthroscopic or keyhole surgery. Very large or massive tears are     difficult to operate on and often have poor rates of healing. As a result surgeons have     investigated the use of products to improve the outcome of surgery on massive tears.      The product that the investigators are currently using to try to improve the outcome of     surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to     support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar     patches have found that recovery is improved and there is a lower rate of postsurgical     problems. The aim of this study is to look at whether using the patch improves pain and the     clinical function of the shoulder after surgery. In addition, the investigators would like to     understand how the patch works. To do this the investigators will scan (take images of) the     shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before     and after surgery.   "
94462|NCT02049671|"     Large population studies of hypopituitary adults (patients with pituitary gland failure) on     conventional hormone replacement, but not growth hormone, have an approximate two fold     increase in death rate (mortality). The vast majority of this excess mortality relates to     vascular disease. While it is possible that overreplacement with steroids, underreplacement     with thyroid hormones and sex hormone deficiency contribute, there are increasing data to     support a role for GH in the cause of the excess vascular risk. Although a number of     surrogates of vascular risk are described in patients with GH deficiency (GHD), how these     translate mechanistically into atherothrombotic (blockage of the arteries) disease has not     been fully elucidated.      This proposed study will analyse both traditional (body composition, serum lipids, handling     of sugars)and more complex markers (inflammation, procoagulation, fibrinolysis) of vascular     risk/disease. In addition the study will examine 24hr blood pressure, arterial wall     thickness, clot structure and function, as well as platelet action. Measurements will be     performed at baseline and will be reassessed after patients have been on a stable dose of GH     replacement for at least three months.      The results of the study will characterise risk factors for vascular disease, and take this a     step further to elucidate how these changes translate mechanistically in to vascular damage.   "
94463|NCT02049658|"     Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy     subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is     hypothesized that sniff dogs may be used as a tool in identifying cancer patients in the high     risk population or suspected patients. Trained dogs will sniff serum from participants who     are suspected to suffer from tumor by their physicians and not yet but will be diagnosed by     pathological examination.The results will be compared with the outcome of the pathological     examination.   "
95120|NCT02041065|"     Before liver transection patients are allocated to either waterjet or CUSA to divide the     liver parenchyma.   "
94468|NCT02049593|"     This phase I trial studies the side effects and the best dose of poly (adenosine diphosphate     [ADP]-ribose) polymerase (PARP) inhibitor BMN-673 when given together with temozolomide or     irinotecan hydrochloride in treating patients with locally advanced or metastatic solid     tumors. PARP inhibitor BMN-673 may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth and may help temozolomide and irinotecan hydrochloride work     better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as     temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving PARP inhibitor     BMN-673 with temozolomide or irinotecan hydrochloride may be an effective treatment for     patients with advanced solid tumors.   "
94469|NCT02049580|"     Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC     regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis     lymphomas.   "
94470|NCT02049567|"     Traditional lenses for cataract patients are monofocal, meaning they offer clear distance     vision, but that patients must wear eyeglasses or contact lenses in order to see clearly     things that are close to them, such as a newspaper.      The FluidVision™ lens that is being tested in this study is designed to allow patients to see     far objects as clearly as with a regular lens, and also to see near objects more clearly than     with a regular lens.   "
95649|NCT02034162|"     The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with     placebo in pediatric participants with Helminth infections.   "
94471|NCT02049554|"     The aims of the intervention are:        1. Assess the feasibility and effectiveness of preconception health care initiated by          pediatric clinicians on outcomes including women's access to primary care and          contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy          interval; and women's immunization rate, control of chronic illnesses, nutritional          status, smoking and substance use, mental health and violence exposure; child and family          health.        2. Assess the cost-effectiveness of preconception health care initiated in pediatric          practices.      The investigators will evaluate these outcomes with a clinic based trial comparing usual care     to preconception care intervention.   "
94472|NCT02049541|"     This phase I clinical trial studies the side effects and the best dose of     phosphatidylinositol-3-kinase (PI3K) inhibitor BKM120 when given together with rituximab in     treating patients with relapsed or refractory low-grade B-cell lymphoma. PI3K inhibitor     BKM120 may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.     Some block the ability of cancer to grow and spread. Others find cancer cells and help kill     them or carry cancer-killing substances to them. Giving PI3K inhibitor BKM120 with rituximab     may be an effective treatment for B-cell lymphoma.   "
94473|NCT02049528|"     The study is being conducted to compare how long 2 oral formulations (a reference and a test     formulation) of CC-122 stays in the body, and whether taking the test formulations with a     high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in     the study, one for each formulation and one for the test formulation + meal. The subjects     will be asked to fast for at least 10 hours before taking the capsule formulations. During     one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being     given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment     sequence which will determine the order in which the subject will receive the reference     formulation, the test formulation, and the test formulation + high-fat meal. Blood samples     will be taken at intervals during the study to assess the amount of drug at those time     points. Blood samples will also be collected at certain time points to determine the levels     of special proteins that may help explain how CC-122 work.   "
94474|NCT02049515|"     A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 monotherapy or     ofatumumab monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small     Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with IPI-145     or Ofatumumab in Study IPI-145-07.   "
94475|NCT02049502|"     The purpose of this study is to test whether Fecal Microbiota Transplant (FMT) is a safe and     effective treatment for people who have Ulcerative Colitis and have had an ileal pouch     anastomosis.      Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that may be caused by a     person's immune system responding in an unusual way to bacteria normally found in the gut.     Studies have shown that the gut bacteria in people with ulcerative colitis (UC) are different     from the gut bacteria in people without ulcerative colitis (UC). Often, people with     ulcerative colitis (UC) have fewer types of bacteria in their gut which can change the way     that person's immune system works.      This study is for people who have had a proctocolectomy with an ileal pouch anastomosis     (IPAA) to treat ulcerative colitis (UC). More than 50% of people who have had an IPAA will     develop a condition called pouchitis. Pouchitis is short or long-term inflammation of the     ileal pouch that was created in order to store waste from your intestines. Patients with     pouchitis are being asked to take part in this study.      Currently, antibiotics, probiotics and prebiotics are used to treat pouchitis. However, it     has been shown that probiotics are not very helpful once the patient stops taking them. In     addition, antibiotics may cause unfavorable side effects. Fecal microbiota transplantation     (FMT) is being studied as another form of treatment for patients with active pouchitis. Fecal     microbiota transplantation (FMT) or stool transplant involves receiving a single fecal     enema from someone who has volunteered to donate their stool.      There are two purposes of this research study:        1. To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for          patients with ulcerative colitis (UC) associated pouchitis        2. To study the changes within the bacteria in the gut in patients with pouchitis (before          and after study treatment) using stool, blood and urine samples   "
94476|NCT02049489|"     This study will evaluate a type of immunotherapy in which the patient's immune system will be     stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's     white blood cells. This vaccine will be tested in patients with recurrent glioblastoma to     assess safety, tolerability and clinical response. Patient's white blood cells (WBC) will be     collected from blood and cultured to yield autologous DC. The DC will be mixed with purified     peptides from the CD133 antigen. The DC vaccine will be given back to the patient over     several months. The goal is to stimulate the patient's immune system to CD133 to kill the     patient's glioblastoma tumor cells.   "
94497|NCT02049216|"     People with osteoarthritis (OA) of the knee attending The Alfred hospital will be invited to     participate in a randomised controlled trial comparing two different types of knee taping.     Both groups will also be prescribed an exercise program to assist in management of their knee     OA.      Hypothesis are as follows:        1. Participants treated with flexible tape with have greater reductions in pain and          improvements on timed performance based measures when compared to those treated with a          placebo tape.        2. Participants in both groups will have clinically significant improvements in pain and          timed performance based measures compared to their baseline scores.   "
94477|NCT02049476|"     The main purpose of this study is to evaluate whether or not the dexamethasone pellet     (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the     treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis in     which immunosuppressive drug therapy is indicated.      Uveitis is an inflammation inside the eye. Uveitis can decrease patients' vision if it is not     treated.      The dexamethasone pellet is an implant filled with a corticosteroid medicine. This therapy is     approved by the Food and Drug Administration (FDA) for the treatment of intermediate and/or     posterior uveitis.      In this study investigators want to see if using the implant together with systemic     immunosuppressive drug therapy can result in lower ocular side effect profile but is     effective enough to replace the use of high-dose systemic corticosteroids in the treatment of     active intermediate and/or posterior uveitis. Knowing the effectiveness and safety of these     treatments is important because the kinds of uveitis being studied usually need to be treated     for many years. This information may help researchers understand uveitis better and may     suggest ways of improving treatment.      Adult patients with intermediate and/or posterior uveitis for which immunosuppressive drug     therapy with high-dose corticosteroid is planned may join.   "
94478|NCT02049463|"     Purpose: To investigate the different sound spectrum of carotid arteries and to analyze its     relationship to the vessel disease, and to build a new biomarker about vascular disorder.      Methods: To record the carotid phonoangiography with digital stereoscopy and analysis the     spectrum with different algorithm such as FFT, wavelet, entropy, complexity, and HHT. The     results will be correlated and comparison to the finding in clinical, carotid Doppler and     duplex, CTA, MR, and catheter angiography.      Statistics:      The significance of difference between parameters was computed using t-tests or paired t-test     etc. A p value <0.05 is defined as significant.   "
94504|NCT02049125|"     The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated     lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney     injury (AKI) development in patients with cirrhosis and bacterial infection and to predict     response to AKI treatment with albumin and albumin with terlipressin in patients with     suspected hepatorenal syndrome.   "
94479|NCT02049450|"     Patients with severe thalassemia (thalassemia major) present with severe anemia that required     life-long transfusion therapy, spleen enlargement that led to increased transfusion     requirement, and other serious complications as early death, growth retardation, bone     deformations and iron overload due to blood transfusions. Splenectomy can significantly     reduce transfusion requirement in thalassemia patients, but it is associated with an     increased risk of serious complications such as sepsis and thrombosis. Preliminary     preclinical and clinical data suggested that JAK2 inhibition, by reducing spleen size, could     improve hemoglobin levels, thereby eliminating the need for splenectomy and reducing     transfusion requirement and related iron overload.   "
94480|NCT02049437|"     The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over clinical     trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving antiretroviral     therapy with suppressed viral replication and CD4+ T cell count ≥350 and ≤1,000 cells/mm3)   "
94481|NCT02049424|"     Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow     after post-transplantation cyclophosphamide   "
94482|NCT02049411|"     - Cognitive changes are related to aging, affecting the performance of older patients in the     solution of problems and the execution of tasks.      This phenomenon has been observed as a decline of neurophysiological domains, especially     memory, and the velocity of thought.        -  Anesthesia and surgery performed contributes to its development then, is named          post-operative cognitive dysfunction (POCD). The incidence varies due to conditions of:             1. Anesthesia and surgery.             2. The time elapsed after surgery.             3. The population studied, and the type of cognitive test employed.        -  The aim of this study is to evaluate the changes around the Short Portable Mental Status          Questionnaire (SPMSQ-E) after ketamine administration on ophthalmic surgery on the          common conditions of geriatric patients, —comorbid and settings as minor surgery—.   "
94483|NCT02049398|"     Background:      - Normal bacteria and other tiny organisms are found in healthy human mouths. These are     called oral microbiota. It is unclear exactly how the oral microbiota may affect health. For     example, if the microbial composition is abnormal, it may lead to mouth conditions like     periodontitis. Researchers want to study how the microbiota changes over time. This can help     them plan future disease studies.      Objectives:      - To see if and how oral microbiota change over time.      Eligibility:      - Forty adult employees of the National Cancer Institute Shady Grove.      Design:        -  For 12 hours before the first visit, participants will not eat or drink (except water).          They will not brush, floss, use mouthwash, chew gum, eat lozenges or candies, smoke          cigarettes, or chew tobacco.        -  At the first visit, participants will:        -  Be given a saliva collector. They will spit 2 mL of saliva into it.        -  Fill out an online questionnaire.        -  Every 2 months, participants will visit the clinic and repeat visit 1.        -  The study ends after 1 year.      Sponsoring Institute: National Cancer Institute   "
94498|NCT02049203|"     This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild     to moderate calcific aortic valve stenosis. The primary focus of these studies will be on     changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without     passing out), and determining whether treatment with Ataciguat results in significant     reductions in blood pressure in this patient population.   "
94499|NCT02049190|"     This is an open-label, randomized, parallel group two-stage phase 1-2 study with an     escalation and an expansion component. This study will evaluate an extended-release (ER)     formulation of onapristone in patients with prostate cancer in which Progesterone Receptor     (PR) may be contributing to tumor progression. A companion diagnostic to select patients     whose prostate cancer expresses the activated form of the PR (APR) is under development and     will be implemented in this study; it may be used to further enrich the selection of the     population based upon ongoing review of the results. Patients will be treated until     occurrence of an intolerable safety issue, treatment failure, if patient elects to withdraw,     or for non-compliance with either protocol-specified evaluations or onapristone treatment. An     additional cohort of patients will be included at the recommended phase 2 dose to gain     additional understanding of the onapristone safety profile and potential anti-cancer     activity.   "
94484|NCT02049385|"     Background:      - Depressed people appear to have problems regulating levels of a brain chemical called     glutamate than people who are not depressed. The drug diazoxide may help regulate glutamate     levels in people with depression. Researchers want to know if it can rapidly improve     depression symptoms. This would help many people with depression, because most medications     take a long time to work.      Objectives:      - To see if diazoxide can quickly improve depressive symptoms in people with     treatment-resistant major depressive disorder (MDD).      Eligibility:      - Adults 18 to 65 years old with MDD, who are currently depressed without psychotic features.      Design:        -  Participants will be hospitalized for the entire study, 11 13 weeks. They may be allowed          short leaves. Participants will be interviewed many times during the study. They will          also fill out questionnaires.        -  Phase I will last about 4 weeks.      <TAB>- Participants will be screened with lab tests, and psychiatric and medical history and     exams.      <TAB> - Participants will slowly go off current medications. They will be drug-free for 2     weeks.        -  Phase II will last about 8 to 9 weeks.        -  Participants will be monitored, answer questions, and give blood samples. They will          drink a glucose drink, give saliva samples, and have scans of their brains taken.        -  Participants will take the study drug daily by mouth for one 3-week session.        -  They will take a placebo daily by mouth for the other 3-week session.        -  There will be a drug-free period of 14 to 21 days between sessions.   "
94485|NCT02049372|"     Our aim was to establish a feasible method to prospectively register all tonsil     surgery-related complications and to find their possible predictive factors. Our long-term     objective is to create a surgical complication registration database, which would provide     valuable information for quality assurance and give us a benchmarking tool to improve the     results of this surgery in our department.   "
94486|NCT02049359|"     The purpose of this study is to determine the impact of two-way short message service (SMS)     on glycemic control in low-income, poorly-controlled adult diabetic patients.   "
94487|NCT02049346|"     * Background: Despite extensive use, to the best of our knowledge, no trial has     simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in     a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients.      * Patients and Methods: All haemodialysis patients in Qatar who were treated with short     acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to     continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous     erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. All groups were     assessed at the end of the study for safety and efficacy parameters.   "
94488|NCT02049333|"     The purpose of this study is to assess and compare the mechanical angle opening in patients     with angle closure due to a plateau iris configuration (elevated iris) using     phacoemulsification combined with endoscopic cycloplasty versus treatment with     phacoemulsification alone.   "
94489|NCT02049320|"     This is a descriptive retrospective study designed to measure the efficacy of remifentanil     sedation and the ability to perform frequent neurological examinations of patients with     traumatic brain injuries.   "
94490|NCT02049307|"     The purpose of this study is to evaluate the potential effectiveness of losartan (100mg     daily) for reducing inflammation and improving immune recovery.   "
94491|NCT02049294|"     The purpose of this study is to investigate whether addition of Omalizumab enables a     reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.      This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial     divided into two sequential study periods.      Period 1: After establishing the minimum dose of prednisone to maintain asthma control and     maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab     for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).      Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical     and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an     exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab     or placebo during the entire duration of the study but not continue the phase of steroid     reduction.   "
94492|NCT02049281|"     This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable     dose. The primary study hypothesis is that administration of vintafolide to participants with     advanced solid tumors will have acceptable safety and tolerability.   "
94493|NCT02049268|"     Nicotine and alcohol are frequently used together and their combined use contributes to more     than half a million deaths each year, with more alcoholics dying from smoking-related     diseases than from alcohol-related diseases. Using a new multi-modal MRI approach combined     with data fusion, the investigators propose to study how nicotine modulates alcohol-induced     changes in the function of brain circuits. The investigators hypotheses are:        -  functional connectivity (FC) in the reward network, containing components of the          mesolimbic dopamine system, will be altered by alcohol, and additional increases in FC          will be observed if nicotine is also present (e.g., additive effects).        -  co-administration of nicotine will counteract the effects of alcohol on FC in multiple          brain networks, including visual, sensorimotor and motor brain circuits, that may be          associated with the impairing effects of alcohol   "
94494|NCT02049255|"     Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical     correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months)     pain.   "
94495|NCT02049242|"     The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss     at open myomectomy.   "
94496|NCT02049229|"     The purpose of the prospective, randomized and a multicenter trial is to compare clinical     outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus     Synergy-EES.      Second objective is to explore whether the Optimax-BAS use is superior compared with     Synergy-EES use with respect of hard end points (cardiac death, MI and major bleeding).   "
94535|NCT02048709|"     This is an open-label Phase I study to evaluate the safety, tolerability, and     pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to     inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system     attack solid tumor cells more effectively.   "
95121|NCT02041052|"     A small gastric remnant after whipple resection improves gastric emptying and therefore     prevents the development of delayed gastric emptying.   "
94500|NCT02049177|"     Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important     questions remain however, regarding the role of specific types of HPV, their effect on     prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with     other risk factors (such as smoking and alcohol), and potential geographical differences in     the effect of HPV.      Via the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) study, which is     an international collaboartive case-control study conducted in 15 centres in 11 European     countries, and pooling our results with the HPV-AHEAD consortium, we will conduct a     systematic analysis of HPV subtypes known or suspected to be involved in head and neck     cancer. This will involve investigation of HPV risk by tumour site (oral, oropharynx,     hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by     exposure to other known or suspected carcinogens including tobacco, alcohol and medical     history.      It is intended that this work will contribute to the development of evidence that may feed     into treatment protocols for these cancers as well as evaluations of the feasibility for     extending HPV vaccine programs.   "
94501|NCT02049164|"     The purpose of this study is to determine the effective dose or dose range of AR08 in the     treatment of VMS in menopausal females.   "
94502|NCT02049151|"     This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in     subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated     either stable disease or objective response following primary concurrent chemo-radiotherapy     (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus     subjects treated with tecemotide-matching placebo.   "
94503|NCT02049138|"     This is a Phase 2, multicenter, open-label extension study in RA subjects.   "
94507|NCT02049086|"     This proposal will develop and test an indicated prevention strategy, Screening, Brief     Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM), in Veterans     who have filed a claim for a (military) service-connected injury for which they have     requested financial compensation. Although typically only an information-gathering,     forensic-styled examination, the Compensation examination is a crucial point of entry to VA     care. Objectives are:        1. To finalize the procedures, manual, and training materials of SBIRT-PM. The goals of          this stage will be (1) optimizing SBIRT-PM's appeal to Veterans concerned about their          musculoskeletal conditions and their Compensation claims; and (2) finalizing the          counseling materials and procedures.        2. To conduct a randomized clinical trial comparing SBIRT-PM to a no referral arm and a          pain module only arm.   "
94508|NCT02049073|"     Noise-induced hearing loss affects an estimated 5% of the worldwide population, with 30-40     million Americans exposed to hazardous sound or noise levels regularly. Sources of noise may     be occupational, blast noise, or recreational. Trauma to the inner ear can occur through     transient hearing loss or permanent hearing loss. Although hearing recovers after temporary     transient hearing loss, growing evidence suggests that repeated temporary transient hearing     loss may lead to a permanent hearing loss. Currently, there are no treatments and there are     no known medications that can be used clinically to prevent noise-induced hearing loss in     humans.      The long-term goal of this research is to find medications that can prevent noise-induced     hearing loss. The purpose of the present pilot study is to evaluate zonisamide and     methylprednisolone as medications to prevent temporary transient hearing loss in humans.   "
94509|NCT02049060|"     This is a prospective, open-label, mono-centric, phase I-Ib trial of Tivantinib in     combination with Pemetrexed and Carboplatin as first-line therapy in patients with advanced     or metastatic cancer suitable for a Carboplatin and Pemetrexed regimen as part of their     specific therapy.   "
94510|NCT02049047|"     Given the high expression of IGF-1R and pAKT proteins in thymoma tissues, able to sensitize     tumors to mTOR inhibition, and the anticancer activity of the mTOR inhibitors, clinical     evaluation in thymoma and thymic carcinoma seems to be very interesting.      Patients will receive continuous treatment with oral everolimus 10 mg once daily.      Efficacy and safety profile of Everolimus will be evaluated.   "
94511|NCT02049034|"     Glucagon-like-peptide-1 (GLP-1) analogues are a new treatment for type 2 diabetes, which have     recently been shown to have beneficial effects on weight, glycaemic control and postprandial     triglyceride concentrations. Postprandial hypertriglyceridaemia, which is associated with an     increased risk of cardiovascular disease, is a feature of type 2 diabetes.     Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of     very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher     molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are     synthesised in the intestine in response to an intake of dietary fat and contain the lower     molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor     signalling is required for the control of postprandial lipoprotein synthesis and secretion in     hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1 receptor     antagonist increased apoB-48 TRL production.      This study will investigate the effect of the GLP-1 analogue lixisenatide compared with     placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12     patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be     measured in a repeated meal study by labelling apoB-100 and apoB-48 and by labelling     triglycerides using stable isotope methodology. Glucose flux in response to a mixed fluid     meal will also be investigated using stable isotope methodology. Gastric emptying and post     heparin LPL activity will be measured.      The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease in     endogenous glucose output and an increase in glucose clearance by peripheral tissues as a     result of an improvement in insulin sensitivity.   "
94536|NCT02048696|"     Patients who have suffered a heart attack are at risk of developing worsening heart function     and heart failure. Exercise training has a beneficial effect on heart function and prevents     heart failure. The aim of the current study is to investigate the effect of exercise training     on heart function in patients who have suffered a heart attack.   "
94537|NCT02048683|"     Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with     control ICU patients.   "
95318|NCT02038491|"     Regional anesthesia is the cornerstone of modern postoperative analgesia, but concerns remain     about possible adverse effects and complication.      RICALOR Group Investigators developed a national registry to register the incidence of     regional anesthesia-associated complications and to identify possible risk factors.   "
94512|NCT02049021|"     Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still     do not respond properly to antipsychotic therapy. These patients are considered     treatment-resistant or refractory, and the best choice for them is clozapine. However, even     supported by the literature as the best known antipsychotic in terms of efficacy and rates of     response, a considerable number of patients will still not respond to this treatment,     remaining symptomatic and dysfunctional. These patients are classified as super-refractory     (clozapine-resistent). In these cases, augmenting strategies are necessary, and some have     been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and     electroconvulsive therapy (ECT). Some studies have favored ECT, but no definitive conclusion     has been drawn.      Objective: Test the electroconvulsive therapy efficacy and safety as augmenting strategy to     clozapine-resistant patients, as compared to placebo (sham ECT).      Methods: This is a pilot double blind, placebo controlled and randomized study to assess     electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory     schizophrenia. The ECT treatment will be delivered with either a MECTA SPECTRUM 5000Q or     4000Q device, and the procedure is under general anesthesia and monitorization, after     informed consent. The Hospital will follow national protocols and regulations on ECT. Sham     ECT consists in habitual patient preparation and sedation, without stimulation. Patients that     fit inclusion criteria will have their clozapine blood levels dosed and undergo structured     assessments at baseline, after 6 treatments and at the end of the cycle of 12 ECT sessions     (thrice a week protocol). The assessments will be based on CGI (Clinical Global Impression)     and PANSS (Positive and Negative Syndrome Scale) scales. All medication will be maintained,     except lithium carbonate.   "
94513|NCT02049008|"     The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians,     because there are no standardized protocols for efficient control of the disease. The aim of     this study is to evaluate the effect of multiple applications of antimicrobial photodynamic     therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients     diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a     split-mouth design study to either aPDT associated with scaling and root planning (SRP) or     SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength     associated with a phenothiazine photosensitizer. The applications will occur in four episodes     (days 0, 2, 7 and 14). All patients will be monitored for 90 days. Clinical assessment of     plaque index, probing depth, clinical attachment level and bleeding on probing will be     performed at baseline (pre-intervention period) and 30 and 90 days after the nsPT.     Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT)     and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard     hybridization. Gingival crevicular fluid samples will be collected (at baseline and 14, 30     and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of     Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained     will be statistically analyzed.   "
94521|NCT02048904|"     The people being asked to participate in this study have type 2 diabetes and abnormal levels     of protein in their urine. This indicates that they are starting to develop diabetic kidney     disease. The standard treatment for this is the use of one of two blood pressure medicines,     either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker     (ARB). However, these medicines are not always completely effective in stopping/reversing the     kidney disease. Some studies have previously suggested that another type of medicine, called     sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from     getting worse.      This study is being performed to test the effectiveness of sitagliptin as compared to a     placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it     will reduce protein levels in their urine. Protein levels in the urine are a marker of the     severity of kidney disease.   "
94522|NCT02048891|"     Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely,     human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the     natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural     cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To     induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing     hormone (GnRH) agonist can be given.      The purpose of this study is to find out which approach may work better in IVF patients who     experienced 4 IVF failures.   "
94523|NCT02048878|"     The purpose of this study is to determine whether individuals with chronic insomnia disorder     have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good     sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic     hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients     with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass     index (BMI) and race/ethnicity.   "
94524|NCT02048865|"     Cancer patients have an increased risk of developing blood clots in the veins compared to     non-cancer patients. Cancer patients who develop blood clots can lead to reduced life     expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most     effective way to decrease the complications associated with blood clots in the veins.     Although previous clinical trials have shown some benefit on the use of medication to prevent     blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive     in demonstrating that existing blood thinners significantly reduce the rate of blood clots in     cancer patients. One possible explanation relates to the fact that these studies have     included a large proportion of cancer patients who are a low risk of developing blood clots     in the veins. We are proposing to identify cancer patients who are at a high risk of     developing blood clots by using a validated tool at the time of their cancer diagnosis. The     identified high risk cancer patients will be asked to participate in a trial to test the     safety and efficacy of a new oral medication that has been used to prevent blood clots in     patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa,     Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will     receive the study drug and 287 will receive an inactive substance. Analysis will be performed     to assess the safety and the superiority of the study drug.   "
94525|NCT02048852|"     This study examines the potential effect of reducing nicotine content or menthol or both in     women of reproductive age, a vulnerable population identified by the FDA in need of further     research.   "
94640|NCT02047344|"     This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients     with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of     anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive     antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An     evaluable patient will have received at least one dose of antroquinonol and have a valid     baseline tumor assessment. Enrollment will continue until the target number of evaluable     patients has been enrolled.   "
94526|NCT02048839|"     SUBJECTS:      All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to     this follow-up study, with their children (age 3-5 years) and the father. The investigations     are carried out during two separate visits. The father receives mail questionnaires      OVERALL OBJECTIVES:        1. To determine the long-term effectiveness of a lifestyle intervention in high risk women          and their offspring             1. in reducing the incidence of T2DM and cardiovascular disease and their risk factors             2. in preventing obesity             3. on biomarkers             4. on genetic and epigenetics markers .        2. To study the association between maternal diet during pregnancy and metabolic markers in          the offspring at age 3-5 years.        3. To study the association between maternal exercise habits during pregnancy and metabolic          markers in the offspring at age 3-5 years.        4. To study the association between maternal a) glucose-insulin metabolism b) lipid          metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later          health outcomes in the mothers and their offspring.        5. To study the association between gut microbiota and markers of offspring health        6. To study the cost effectiveness of the intervention.      METHODS:      Maternal measurements        1. Height, weight, waist and hip circumference        2. Blood pressure, pulse        3. Body fat percentage        4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone          markers, DNA sample and inflammation markers        5. Fecal and hair samples        6. Diurnal salivary cortisol assessment        7. Background questionnaire: socioeconomic and health-related background        8. Health-related quality of life (15-D).        9. 3-day food diary and exercise diary       10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days       11. Psychological questionnaires       12. Pulse wave velocity (PWV) will be assessed       13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed      Paternal measurements        1. Background questionnaire (incl. height, weight, age)        2. DNA-sample (buccal)        3. 3-day food diary        4. Psychological questionnaires      Measurements of children        1. Body weight, height, blood pressure, pulse        2. Body fat percentage        3. Psychological questionnaires        4. Food and physical activities diaries        5. ActiGraph, assessment of physical activity and sleep for 7 days        6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and Calcium,          DNA-sample and samples for inflammation markers        7. Fecal, urine and hair samples        8. A copy of child welfare center card (e.g. data on growth, immunizations, health)        9. Endothelial function and pulse wave velocity (PWV)      TIMETABLE      Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2016     and results will be reported from 2016 onwards in international peer-reviewed journals.   "
94527|NCT02048826|"     The purpose of this study is to determine the effectiveness of training hand movement using     FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users     to play computer games using those movements.   "
94603|NCT02047825|"     Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact     and economic consequences. It is caused by damage to the myelin sheath, the protective     covering that surrounds nerve cells. Different areas are affected, including manual     dexterity, strength, coordination and function. The objective of this study is to evaluate     the improvement in these variables in patients with multiple sclerosis after a 8-weeks     intervention focused on upper limbs.   "
94529|NCT02048800|"     Every year around 70 children affected by cancer or life-threatening genetic diseases undergo     haematopoietic cell transplantation (HCT) within the Blood and Marrow Transplant (BMT) unit     at Great Ormond Street Hospital (GOSH).      One of the main goals of the BMT unit over the last decade has been to reduce the morbidity     and mortality related to HCT, and the group has become a world-leader in pioneering less     toxic transplants.      Fixed high doses of chemotherapy drugs are generally used to prepare children for HCT but     several studies have shown a correlation between the concentration of these drugs achieved in     the patient's blood, and the success or failure of the HCT procedure.      Recently a new drug, Treosulfan, has become available for use in patients undergoing HCT, and     GOSH has pioneered its introduction in children undergoing HCT. With promising early results,     Treosulfan has become the pre-HCT drug of choice, however, very little is currently known     about how the drug is metabolised and cleared from the body, particularly in children.      The investigators therefore plan to investigate the pharmacokinetic (PK) profile of     Treosulfan in children undergoing HCT at GOSH and define which parameters affect its     metabolism and clearance, and what blood levels are associated with a favourable outcome     (graft take without toxicity) or a poor result (graft rejection and/or toxicity).   "
94530|NCT02048787|"     To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral     dose in subjects with moderate and severe renal impairment.   "
94531|NCT02048774|"     Obesity is often cited as being inversely related with socioeconomic status (SES), although     the mechanisms linking social status with obesity are not well understood. Dietary restraint,     physical activity, and social mobility have been proposed as possible mechanisms. Although     there is some evidence of SES variation in the proposed mechanisms, evidence is mixed and     mostly observational. The purpose of this research is to determine if one's social position     influences eating behaviors. This study will attempt to determine this using a randomized, 2     parallel arm trial to determine the effects that social hierarchy positioning has on energy     intake. To prevent compromise in the integrity of data, the investigators will detail the     exact treatment condition (i.e., social positioning) after the data collection period.      Based on findings from previous animal and large clinical observational studies, there are     two complementary hypotheses tested in this study. First, it is hypothesized that being in a     lower social position affects one's perception of food availability by making the future     availability of food seem less certain. This uncertainty will lead to increased food     consumption. Second, it is hypothesized that being in a position of power will lower one's     food consumption, as previous research has found that individuals in power tend to east less     in groups. Understanding how social position influences food intake could help improve weight     loss/maintenance interventions by identifying unexpected factors that could limit the     intervention's effectiveness.   "
94532|NCT02048761|"     This study was designed as a randomized, controlled clinical trial to evaluate the efficacy     of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects     in chronic periodontitis in comparison with placebo gel.   "
94533|NCT02048748|"     Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may     provide benefits on health care costs and quality of life. Currently there is limited use of     remote monitoring for heart failure in Norway. The funding streams and the structure of the     norwegian health service is different from other countries that have tried remote monitoring     and therefore it is important to examine the utility of such services in Norway. The study is     a randomised controlled trial that will allow participants in the intervention group to use a     wireless weight scale and blood pressure monitor device that will send automatically the     measurements electronically and securely to the Heart Failure Outpatient Clinic of the     hospital.   "
94534|NCT02048722|"     The purpose of this study is to see whether a drug called regorafenib might be effective in     treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse     after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor.     Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer     cells might normally help the cancer cells grow or form new blood vessels that could feed a     growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain     cancers.   "
94538|NCT02048670|"     This pilot study is focused on what assistance an external prosthetic device, the     BalanceBeltTM can provide in the: 1) assessment and 2) treatment for patients with Chronic     Subjective Dizziness (CSD). The BalanceBelt has sensitive detectors for movement in the     anterior/posterior and medial/lateral planes and provides the person wearing the device     vibro-tactile feedback as to the persons orientation with respect to gravity. The device is a     full self contained device that is comfortably worn around the waist over a light weight     shirt. The device is non-FDA approved and is in its final stages of beta testing. Patients     with CSD do not have permanent vestibular deficits, but underutilize vestibular signals     because they develop visual or somatosensory dependence. The investigators expect the     BalanceBeltTM to reset this error by providing patients with reliable motion stimuli.   "
94539|NCT02048657|"     Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed.     The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a     soft, direct optical Foley airway stylet tool (FAST) and compared with the standard     introducer-tool (I-Tool).   "
95101|NCT02041312|"     Investigators have a plan to conduct nested case-control study to investigate the association     between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG),     apolipoproteins and gastric neoplasm. In addition, further analyses were performed to     evaluate the possible role of the serum cholesterol as a predictor for the differentiation     and prognosis of gastric neoplasm.   "
94540|NCT02048644|"     The investigator has recently studied markers of platelet activation in idiopathic pulmonary     fibrosis (IPF) and found that in IPF patients there is a significantly increased platelet     reactivity when compared with controls which is demonstrated by a concentration dependent     increase in platelet-monocyte complex formation, platelet P-selectin expression and platelet     fibrinogen binding in the presence of` the platelet agonists Adenosine diphosphate and L-     Threonyl- L- phenylalanyl- L- leucyl- L- leucyl- L-argininamide (TFLLR).      During platelet activation the platelets degranulate releasing numerous profibrotic cytokines     including Transforming growth factor beta and Platelet derived growth factor that are     recognised to be important in the pathogenesis of IPF. It is therefore plausible that the     observed increased platelet reactivity in IPF contributes to the fibrotic process through     local activation and degranulation with release of proinflammatory and profibrotic mediators     within the pulmonary circulation.      There is evidence that corticosteroid treatment may alter platelet adhesion, in a study of     spontaneously hypertensive rat (SHR) increased circulating glucocorticoid, suppressed     p-selectin expression. p selectin is a transmembrane protein present in the α granules of     platelets. P selectin has a crucial role in platelet aggregation and platelet-leukocyte     interactions, which are both potentially important mechanisms in the initiation and/or     progression of tissue injury and development of thrombosis. In a study of patients with     chronic obstructive pulmonary disease (COPD) exacerbation these were treated with either β     agonists alone or β agonist and 40mg prednisolone and compared with a control group. At     presentation the COPD patients had higher pulmonary artery pressure (PAP) higher p selectin     and fibrinogen levels but lower Antithrombin III levels (AT III). The pulmonary artery     pressure and fibrinogen levels were found to be significantly decreased in the steroid     treated group whilst the p-selectin levels further increased in the non steroidal therapy     patients.      Rationale for the Current Study      There is a significant unmet medical need for the treatment of IPF; the only medication     approved for treatment of IPF in the United Kingdom (UK) is Pirfenidone and outside the UK     there is none. The main goal of the current study is to evaluate the effect of Fostair on the     biomarkers of platelet activation in IPF disease which the investigator believes play a     pivotal role in the pathogenesis of IPF and whether this translates in to a clinically     beneficial effect of Fostair on IPF disease.   "
94541|NCT02048631|"     The aim of the study is to investigate post-surgery sensory impairment and life quality     changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6     months, 12 months, and 24 months, respectively   "
94542|NCT02048618|"     -  180 patients suffering from active Crohn's disease with evidence of mucosal ulceration          will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or          matching placebo once daily for 20 weeks in addition to their stable background          treatment.        -  During the course of the study, patients will also be examined for any side effects that          may occur (safety and tolerability), and the amount of GLPG0634 present in the blood          (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of          action-related parameters in the blood and stool (Pharmacodynamics) will be determined.          Also, the effects GLPG0634 administration on subjects' quality of life will be          evaluated.   "
94543|NCT02048605|"     Patients with Parkinson's disease (PD) will be trained using a cognitive behavioral     group-training-program to reduce stress and augment quality of life. An unspecific group with     the same amount and frequency of meetings is used as a control group. For the evaluation of     the training effects, scales to assess quality of life, analyses of psychopathological     variations as well as neurocognitive tests will be used. Protocol amendment in 1-2017:     addition of FU year 3 and year 5.   "
94544|NCT02048592|"     The primary objectives:      To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis        1. Safety of immunonutrition        2. The effect of immunonutrition on parameters of oxidative stress        3. The effect of immunonutrition on the inflammatory parameters        4. The effect of immunonutrition on nutrition status      Hypothesis      The high oxidative stress is present in patients with cystic fibrosis. Immunonutrition has     been shown to positively modulate oxidative stress in the different clinical setting however     it has not yet been evaluated inpatients with cystic fibrosis who frequently need some     support by means of enteral nutrition. We anticipate that the substitution of routine enteral     nutrition by immunonutrition will result in improving of oxidative stress parameters.   "
94554|NCT02048462|"     Many studies have shown that vigorous exercise increases the risk of developing vascular     thrombotic events and can result in sudden death during or immediately after exercise. The     outcome of these studies is biased by several confounding variables: subjects, type of     exercise, duration, intensity and especially the method used for the evaluation of the     hemostatic capacity. The goal of our study is to investigate the effect of strenuous exercise     with the Calibrated Automated Thrombogram (CAT) assay, which is an established tool in     detecting hyper- and hypocoagulabilty conditions. We modified the CAT assay to make it also     feasible to measure TG in whole blood (WB-CAT), not only to go one step closer to physiology     since all the blood cells are present, but also to avoid the centrifugation step. With our     study we would like to see whether the other blood cells also play a role in the increase in     TG. The objective is to investigate the effect of strenuous exercise (participation to the     Amstel Gold Race) on coagulation and haemostatic parameters. We hypothesize that strenuous     exercise induces a prothrombotic phenotype and that especially the tests involving blood     cells will be altered into a prothrombotic phenotype.   "
94641|NCT02047331|"     In this study, the aim is to compare the efficacy of Periarticular multimodal drug     injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee     arthroplasty.   "
94642|NCT02047318|"     The purpose of this extension study is to determine the long-term safety and tolerability of     an investigational treatment (LUM001) in children with ALGS who have completed participation     in the LUM001-302 study.   "
94545|NCT02048579|"     Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated,     parent-teen-teacher collaborative intervention for middle school students with ADHD and     academic impairment (STAND; Supporting Teens' Academic Needs Daily). [This model was chosen     because of its potential ability to promote treatment maintenance and generalizability across     school years, because parents will be taught to implement, monitor, and adjust intervention     components as needed. Key innovative components in the STAND intervention address previously     reported treatment barriers: 1) a parent-delivered academic intervention to promote     maintenance and generalization across school years, and to relieve some of the burden of     intervention delivery from teachers, 2) motivational interviewing to address parent     disengagement from and adolescent resistance to the treatment process, 3) multiple tailored     options for home-school communication, including a web-based support system, to facilitate     home-school communication, and 4) empowering parents by coaching them to effectively and     tactfully involve teachers in the treatment planning and monitoring process in order to     increase teachers' willingness to support the child's academic needs. To study the     feasibility and preliminary efficacy of the STAND treatment model,] two cohorts of 42 middle     school students with ADHD will be recruited (total N=84) and randomly assigned to participate     in STAND or a treatment-as-usual monitoring group. All participants will complete intake,     mid-treatment, post-treatment, [and follow-up] assessments designed to monitor academic     functioning, [intervention feasibility, compliance, and satisfaction].      Aim 1: The proposed study will evaluate the efficacy, [maintenance, and cross-school year     generalization] of a parent-teen-teacher collaborative intervention (Supporting Teens'     Academic Needs Daily; STAND) vs. treatment as usual to increase the academic functioning of     middle school students with ADHD. Intervention effects on ADHD symptomatology and impairment,     grade-point-average (GPA), [organization, daily planner use], homework completion, teacher     ratings of academic functioning and classroom behavior, and the parent-teen relationship will     be examined.      Aim 2: The proposed study will examine the acceptability and feasibility of the STAND     program. Parents and teens will report on [satisfaction, barriers to treatment participation,     therapeutic alliance, and treatment credibility] throughout the intervention and follow-up     period. [Therapists will also complete ratings of parent and adolescent engagement and     compliance with treatment procedures] will be collected from participants in the program.     Parent, teen, and teacher compliance with intervention procedures will also be measured in     order to assess feasibility. Treatment fidelity measures will also be collected in order to     measure clinician adherence to the manualized STAND procedures.      Aim 3: The proposed study will also explore ways to improve home-school communication during     the middle school years. To this end, families will be given options regarding the modality     of communication with teachers, and parent, teen, and teacher preferences for medium of     intervention delivery will be examined (i.e., web-based, email, paper/pencil).   "
94546|NCT02048566|"     Hemodynamic management of critically ill patients is a constant challenge in the intensive     care unit (ICU). Commonly used monitoring parameters to guide hemodynamic management     generally consist of measurements of pressures (systemic and pulmonary artery pressures,     cardiac filling pressures) and flow (cardiac output measurements using a thermodilution     method). However, cardiac filling pressures and flow data have known limitations and might     not accurately represent cardiac preload and contractility. Hemodynamic management of     critically ill patients based on these parameters might therefore not be optimal and delay     stabilisation of the patient, leading to negative outcomes and increased use of resources.      Visualization of the heart using echocardiography offers the advantage of direct measurement     of cardiac volumes and systolic function. Echocardiography has been established as a tool to     evaluate the causes of hemodynamic instability in ICU patients by the visualization of     cardiac chambers, valves and pericardium and cardiac functional abnormalities. A repeated     echocardiographic assessment could potentially provide useful additional information     resulting in more rapid resolution of hemodynamic instability. Using conventional TTE and     TEE, however, limits the feasibility of such an approach due to a lack of time and     availability of appropriately trained staff.      In recently published studies the feasibility of hemodynamic monitoring and safety of hTEE     was demonstrated. In the context of a prospective quality review assessment, the     investigators showed that the echocardiographic examinations using hTEE were of sufficient     quality in a majority of examined ICU patients and that the inter-rater reliability between     the intensivists and a trained cardiologist was substantial. However, as of yet studies     assessing the impact of hemodynamic monitoring by hTEE on relevant patient outcomes are not     available. Given the associated costs for the hTEE device and the ultrasound probes and the     additional resource requirements for training and application, the efficacy and efficiency of     hTEE monitoring in comparison to standard monitoring should be established.   "
94547|NCT02048553|"     Background: Despite the widespread use of external ventricular drainage, revision rates and     associated complications are reported between 10-40%. Current available image-guided     techniques using stereotaxis, endoscopy or ultrasound for catheter placements remain     time-consuming techniques. Recently, a phone-assisted guide with high precision has been     described. The development of an easy-to-use, portable, image-guided system could reduce the     need for multiple passes and improve the rate of accurate catheter placement. This study aim     to compare prospectively in a randomized controlled manner the accuracy of the freehand pass     technique versus an an easy-to-use, portable mini-tablet-assisted guide for ventriculostomy     catheter placement.      Methods/Design: This is a single center, prospective, randomized, trial with blinded endpoint     (ventricle catheter tip location) assessment. Adult patients with the indication for     ventriculostomy, as proven by computed tomography (CT), will be randomly assigned to the     treatment group or the control group. In patients of the treatment group, ventriculostomy     will be performed using a mini-tablet-guided assistance based on preoperative CT imaging.     Patients in the control group will receive standard free-hand ventriculostomy using     anatomical landmarks. The catheter may be placed for external drainage or internal     (ventriculoperitoneal) shunting in both groups. The primary outcome measure is rate of     correct placements of the ventricular catheter, defined as a score of 1 to 3 on grading     system for catheter tip location on postoperative CT scan. Primary outcome will be determined     by one of the authors (NS) blinded for treatment allocation. We aim to include 320 patients     in 3 years.      Secondary Outcome Measures include 1) Frequency of placements required, 2) Frequency of     completed placements within the ventricle of the perforated part of the tip of the catheter,     3) Frequency of very early and early shunt failures (revision of the ventricular drainage     within 24 hours / within three weeks, 4) Frequency and Percentage of complications     (procedure-related and nonsurgical) within three weeks, 5) Length of the trajectories from     the dura level to the foramen of Monroe, the angle in the coronal plane towards midline (a)     and towards the target (b) at the respective entry point, 6) ventricle size (the frontal     occipital horn ratio (FOHR) and the width of the lateral ventricle in the coronal plane     between the medial wall of the corpus callosum and the septum), 7) Differences (angles,     distance of catheter tip from target) on the tablet-guided planned and postoperative     trajectory on control computer tomography within 48 hrs (CT).      Discussion: Here, we present the study design of a single center prospective randomized     controlled trial to investigate whether tablet-guided application ventriculostomy is superior     to the standard free hand technique. The strengths of this study are: 1. the prospective,     randomized interventional character testing a new easy-to handle guided versus free-hand     ventricular catheter placement, and 2. the power calculation is based on catheter accuracy     using an available grading system for catheter tip location and calculated with use of recent     study results of our own population, supported by data from prominent studies.   "
94548|NCT02048540|"     Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0     resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough.     Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy     has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator     of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to     evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF)     versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness     indicator.      Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1)     to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin,     85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2,     d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles     postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was     detected every 8 weeks. All patients signed the informed consent.   "
94549|NCT02048527|"     Sequential culture media were introduced in order to meet the changing requirements of the     developing embryo in vitro. However, there has been renewed interest in the use of     single-step media, which allow the embryo itself to choose the necessary nutrients while     maintaining a more stable culture environment. Previous studies suggest that sequential media     do not appear superior to single-step media.   "
94550|NCT02048514|"     The purpose of this clinical study is to evaluate the safety and device performance of the     Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal     abdominal aortic aneurysms.   "
94551|NCT02048501|"     The purpose of this study is to gain a better understanding of the mechanism of weight regain     through gut hormone (substances in the gut that control various functions of the digestive     organs) and energy expenditure (the amount of energy a person uses to complete bodily     activities).      Our hypothesis is that gut hormone response might be different among subjects who are able to     maintain weight loss and subjects with weight regain.      For this study, investigators will measure fasting and postprandial (happening after a meal)     gut hormones, bile acid, amino acids, vitamin B, vitamin D, myokines and adipokine levels in     obese individuals who are at least 2 years after a Roux-en-Y gastric bypass (RYGB).     Investigators will also measure resting metabolic rate (RMR) (the amount of energy expended     daily) and body composition (the proportion of fat, muscle, and bone of an individual's     body). The subjects body composition will be analyzed, including fat mass and fat free mass,     by a Dual-Energy X-ray Absorptiometry (DEXA). This study will provide more information     regarding the effect of RYGB on gut hormones, adipokines, bile acids, amino acids, and energy     expenditure and body compositions.   "
94552|NCT02048488|"     TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer,     including:        1. Anaplastic lymphoma kinase (ALK)        2. The tropomyosin-related kinases TRKA, TRKB, and TRKC      This is a sequential, open-label, non-randomized study with dose escalation in Phase 1,     followed by expansion at a recommended phase 2 dose.   "
94553|NCT02048475|"     To study the behavior of EEG during changing desflurane concentrations.   "
94570|NCT02048254|"     -  To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to          treat inoperable salivary gland carcinoma.        -  To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat          inoperable salivary gland carcinoma.   "
99090|NCT01989130|"     The purpose of this study is to determine if immediate availability of GeneXpert® CT/NG test     results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia     and to assess changes in clinician management decisions with real-time test results.   "
94555|NCT02048449|"     Title:      Inter-rater reliability of the reflux finding score based on endoscopic laryngeal findings in     the diagnosis of laryngopharyngeal reflux disease      Participants:      Voluntary participants after invitation among members (a total of about 40     gastroenterologists) of Gangwon Branch of Korean Society of Gastrointestinal Endoscopy and an     otorhinolaryngologist      Primary endpoint:      Interrater reliability (Kappa coefficient) on the sum of reflux finding score more than 7     points between an otorhinolaryngologist and gastroenterologists (7 points means the cut-off     value for the diagnosis of laryngopharyngeal reflux disease)      Secondary endpoint:      Agreement (%) on 8 items of reflux finding score for laryngopharygeal reflux among     gastroenterologists   "
94556|NCT02048436|"     The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system     Respiration Rate technology.   "
94557|NCT02048423|"     1. Investigate the safety and effectiveness of a single dose of IV Ketamine for adolescents          with suicidal ideation and depression. It is hypothesize that Ketamine will be well          tolerated and significantly reduce depressive symptoms and suicidal ideation.        2. Explore whether decision making as measured by the Iowa Gambling Task changes before and          after Ketamine infusion. It is hypothesize that IV Ketamine infusion will significantly          improve the decision making ability a measured by the Iowa Gambling Task in adolescents          that are suicidal.   "
94558|NCT02048410|"     Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to     evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a     combination of probiotic and prebiotics and amine in the treatment of children affected by     familial hypercholesterolemia (FH).   "
94625|NCT02047539|"     The primary objective of this study is to determine whether aspirin is effective in     alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The     investigators further aim to determine whether it may delay or prevent the onset of psychosis     in those currently experiencing CHR symptoms. As secondary measures the investigators aim to     collect laboratory studies of inflammation markers and genetic samples to determine whether     certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.   "
94559|NCT02048397|"     The effect of Pulmonary Rehabilitation in patients with bronchiectasis (BC) is not     sufficiently studied. The aim of this study is to assess the clinical and biological response     of a Pulmonary Rehabilitation Program (PRP) for 12 weeks in BC vs PRP plus hyperproteic oral     nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB).      Methods: single center randomized controlled trial, parallel treatment design: Participants     will be randomized assigned either will receive (n=14) PRP for 60 minutes, two supervised     sessions per week in the hospital and one unsupervised session at home vs PRP (n=14) plus ONS     (one can per day).      Outcome assessments will be performed at baseline, 12 weeks and 24 weeks:      1.- effort capacity &#8211;cardiopulmonary exercise test-, 2.- body composition     (anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance, phase     angle), 3.- peripheral muscle strength (dynamometry and respiratory -PEM (maximum expiratory     pressure)and PIM (minimum expiratory pressure)-), 4.- spirometry, 5.- respiratory symptoms     (bronchorrhea, dyspnoea, exacerbations),6.- level of physical activity (IPAQ questionnaire     plus objective physical activity (WGT3X)), 7.- quality of life (QOL-B-Spain) ,     8.-psychological symptoms (HASD) and 9.- biological markers of inflammation (leptin,     adiponectin, interleukin-6, tumor necrosis factor-alpha, ultrasensitive C-reactive protein,     GPR55 (G protein-coupled receptor 55) RNAm (messenger ribonucleic acid) expression in white     blood cells) and oxidation (total antioxidant capacity, superoxide dismutase activity,     8-iso-prostaglandin F2a, Thiobarbituric acid reactive substances).   "
94560|NCT02048384|"     This is a phase 1b, multi-center, open label, randomized study to evaluate the safety and     feasibility of administering metformin with or without rapamycin after disease stabilization     on chemotherapy in subjects with metastatic PDA.   "
94561|NCT02048371|"     Although regorafenib was approved for use in patients who had progressive GIST despite     imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been     examined in a systematic fashion in patients with other forms of sarcoma.      Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and     evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like     sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as     regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule     oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have     overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most     of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth     factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a     common mechanism of action of several of these agents.   "
94562|NCT02048358|"     In this first in human study the aim is to assess the safety, pharmacokinetics and     pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and     active comparator- controlled 3-way crossover study in 18 healthy male subjects (part 1).     Furthermore, the findings obtained from part 1 will be extended and confirmed in a subsequent     parallel open label study in 18 healthy male and 12 MS patients and an open label study with     methylprednisolone as comparator in 12 female volunteers (part 2).   "
94563|NCT02048345|"     The aim of this study is to understand the behavior of posaconazol gives as a suspension and     solution in the gastrointestinal tract in human volunteers. The investigators know that     supersaturation for this compound can be achieved by the influence of the gastrointestinal     tract: The acid environment of the stomach creates a optimized environment for the basic     compound to reach a high solubility, while the neutral environment of the small intestine     creates a low solubility environment for the compound. The transit from stomach to small     intestine gives the opportunity for the drug to create a supersaturated solution. Giving the     drug as a solution to the healthy volunteer makes sure that precipitation is not occurring in     the stomach and that precipitation has to happen in the small intestine. After all,     supersaturation is a state that is not thermodynamic stable and always will want to     precipitate. Giving the drug as a suspension to the healthy volunteers, can make it possible     that still some particles of the drug are not in dissolution and that those particles will     flow to the small intestine where other particles easily can bind to. This will make that     almost the whole supersaturated solution is immediately precipitated.      The investigators want to give the suspension by the authorized drug called Noxafil. On the     other hand an aqueous solution will be made by adjusting the pH to 1.2 (which is conform with     the pH of the stomach) and given to the volunteers by the stomach catheter. This 2     formulations will be tested in a fasted state and a fed state (by giving 2 Ensure plus shakes     to the volunteers before the experiment starts). After intake of the formulation, gastric and     duodenal fluids will be aspirated by the catheters and analyzed at their laboratory. So the     four conditions the investigators want to study are:        1. 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water          in a fasted state        2. 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil) in          247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a fasted          state.        3. 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water          in a fed state (by giving 20 minute before intake of the formulation, 2 ensure plus          shakes)        4. 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil) in          247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a fed          state (by giving 20 minute before intake of the formulation, 2 ensure plus shakes).      By getting more knowledge about the behavior of posaconazol (interplay supersaturation /     precipitation) more insights can be achieved for the development of supersaturating drug     delivery systems.   "
94564|NCT02048332|"     In this research study, we want to learn more about the use of donor-derived cytotoxic     T-cells (CTLs) to treat viral infections that occur after allogeneic stem cell transplant. A     cytotoxic T cell is a T lymphocyte (a type of white blood cell) that kills cells that are     infected (particularly with viruses). Allogeneic means the stem cells come from another     person. These CTLs are cells specially designed to fight the virus infections that can happen     after a bone marrow transplant.      We are asking people who have undergone or will undergo an allogeneic stem cell transplant to     enroll in this research study, because viral infections are a common problem after allogeneic     stem cell transplant and can cause significant complications including death.      Stem cell transplant reduces a person's ability to fight infections. There is an increased     risk of getting new viral infections or reactivation of viral infections that the patient has     had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV) and adenovirus     (ADV). There are anti-viral medicines available to treat CMV, EBV and ADV infections, though     not all patients will respond to the standard treatments. Moreover, treatment of viral     infections is expensive and time consuming, with families often administering prolonged     treatments with intravenous anti-viral medications, or patients requiring prolonged     admissions to the hospital. The medicines can also have side effects like damage to the     kidneys or reduction in the blood counts, so in this study we are trying to find an easier     way to treat these infections.   "
94583|NCT02048085|"     This study involves doing platelet function testing in patients who have undergone     fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of     care to restore blood flow in blocked arteries as soon as possible after the Heart attack     in rural health center where access to cardiac catheterization is one hour away. Fibrinolysis     is done by the emergency room physician in a timely fashion to minimize the damage of the     myocardium. Additionally anti-platelet regimen as adjuvant for patient undergoing     fibrinolysis has been well studied in many trials. In this study investigators will use     clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by     measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs     (Pharmacokinetics).   "
94565|NCT02048319|"     Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the     general population, typically not causing any symptoms or complications. However, in a small     subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea     occur.      Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients with     a large dominant liver cyst. However, studies reported early fluid reaccumulation and     relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately     leading to re-interventions. In this respect, somatostatin analogues are promising agents     known for its volume reducing effect in patients with polycystic liver disease.      In this study the investigators want to evaluate the effect of combining aspiration     sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue Pasireotide.      The investigators hypothesize that administrating pasireotide before and after aspiration     sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater     reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst     recurrence and subsequently lower need for re-interventions.   "
94566|NCT02048306|"     The purpose of this study is to explore the impact of Family-based pulmonary rehabilitation     (PR) on patients with chronic obstructive pulmonary disease (COPD) and their family members.      Dyads (patient and respective family member) will be randomly allocated to either a     Family-based PR group or a Conventional PR group. PR programs will consist of exercise     training and psychoeducation. In the Family-based PR program, both patients and family     members will participate in psychoeducation sessions. In the Conventional PR group, only     patients will be included. In both groups, exercise training sessions will be exclusively for     patients.      It is expected that, by including patients with COPD and their family members in Family-based     PR, they will become more competent and confident in the management of the disease, thus     reducing the overall impact of COPD on patients and family members' well-being.   "
94567|NCT02048293|"     Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded     molecules of Remifentanil have been marketed in Colombia, and several reports by     anesthesiologist indicate that there are differences in the physiologic response of patients     to these molecules. The investigators hypothesized that unbranded molecules of remifentanil     require higher doses to obtain desired physiological responses as compared to the branded     molecule.   "
94568|NCT02048280|"     Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the     diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount     of support provided is determined in part by the NAVA level, where a higher NAVA level will     provide higher level of support and unload more of the work of the diaphragm. The purpose of     this study is to compare the optimal NAVA level in neonates while on mechanical ventilation     while intubated and after being extubated.   "
94569|NCT02048267|"     Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic     chronic pancreatitis such as analgesic medication, inhibition of gastric acid production,     enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and     endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting     benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic     chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on     the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not     available in literature.      Although it is well known that pain is the main symptom of chronic pancreatitis, it has until     now been assessed in very common and varying categories. Pain, however, is only one aspect of     the large variety of sensitive facets of daily life. In addition to an improvement in pain     symptoms and the preservation of pancreatic exocrine and endocrine function and other     parameters, occupational rehabilitation of these mostly young patients and quality of life     also should be considered in the evaluation of surgical outcome in alcoholic and     non-alcoholic chronic pancreatitis.      In this prospective study, we intend to find out if there are any differences in the surgical     outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic     pancreatitis.We also plan to see if there are differences in the histopathology in these two     disease settings.   "
94571|NCT02048241|"     Children with explosive aggression are often rejected by their peers, placed in special     classroom, and contribute to family discord. When psychotherapy and family therapy is     unsuccessful, medications are often used. Current medications are stimulants (e.g.     methylphenidate, dextroamphetamine), anticonvulsants (e.g. Divalproex) and antipsychotics     (olanzapine, risperidone). At this time, the available medications are of limited usefulness,     either because they do not always work or because they have side effects such as weight gain     or insomnia. There is a clear need for new medications to treat explosive aggression when     psychotherapy is unsuccessful.      The hypothesis of this study is the medication Intuniv when combined with psychotherapy will     be more helpful to children with explosive aggression than placebo combined with     psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA     for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor is     it an anticonvulsant, nor is it an antipsychotic.      The children in this study will be between the ages of 6 and 12 and meet Diagnostic and     Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for     Intermittent Explosive Disorder.   "
94572|NCT02048228|"     Clopidogrel, in addition to aspirin, is the cornerstone of therapy in patients suffering from     Acute coronary syndrome. However, the platelet inhibitory response to clopidogrel varies     substantially among individuals. Several loss‐of‐function polymorphisms have been identified     that may influence clinical outcome in patients presenting with acute coronary syndromes     (ACS) who are treated with clopidogrel. However their contribution to high on-treatment     platelet reactivity (HPR) in clopidogrel treated Chinese patients is less known. As far as we     know, ticagrelor is not dependent on gene-based metabolic activation and demonstrated greater     clinical efficacy than clopidogrel in a recent secondary prevention trial. we will conduct an     interventional study to compare the antiplatelet efficiency between clopidogrel and     ticagrelor by the guidance of CYP450 2C19*2 (CYP2C19*2) , using Taqman genotyping method.   "
94573|NCT02048215|"     Brief Summary This trial was part of a sub-project targeted to diet, thermogenesis and     obesity of a larger multicentre study named Interaction between nutritional,     social-behavioral and metabolic factors for prevention of cardiovascular disease: development     of nutritional strategies on general population.      Ephedrine and caffeine (EC) combination has been widely used in human obesity treatment. It     is known that this drug increases the metabolic rate in both animals and humans. Ephedrine is     an agonist of both α and β-adrenoceptors; moreover, it induces norepinephrine release from     sympathetic neurons. Caffeine increases both norepinephrine and dopamine release and     stimulates the neuronal activity in several brain regions. We hypothesize that EC treatment     might exert a specific effect on lipolysis and thermogenesis by stimulation of beta-3     adrenoreceptors on adipose tissue and by stimulating uncoupling of oxidative phosphorylation,     i.e. energy being dissipated as heat rather than being converted to adenosine triphosphate     (ATP)      Our study is a double-blind, placebo-controlled, 4-week trial to investigate the effect of     hypocaloric diet alone or coupled to EC treatment of morbidly obese women on thermogenesis,     expression of UCP 3 (in muscle tissue) and of beta-3 adrenoreceptors (in adipose tissue).     Subjects are randomly assigned to EC (200/20 mg) or to placebo administered three times a day     orally together with a energy-deficit diet (70% of resting energy expenditure), starting one     month before undergoing bariatric surgery. Primary study endpoints are weight change analysed     by intention to treat, changes in resting energy expenditure, UCP3 (long and short isoform),     messenger ribonucleic acid (mRNA) levels in rectus abdominis and immunostaining for beta-3     adrenoreceptors in subcutaneous and omental adipose tissue. Also plasma epinephrine,     norepinephrine, triglycerides, free fatty acids, glycerol, TSH, free thyroxine (fT4), free     triiodothyronine (fT3) fasting glucose, insulin and homeostasis model assessment (HOMA)     index, are measured at baseline and at the end of treatments.   "
94574|NCT02048202|"     The study will compare intervention by Infant Aquatics to infant massage. The intervention in     both methods will start at 36 weeks gestational age for 3 months and will consist of sessions     with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18     months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive     behavior scales.   "
94575|NCT02048189|"     This is an open multicentre, randomized study to compare two treatment arms. One arm called     intensification of multiple injections in which the patient will receive one supplementary     injection of LEVEMIR®: that is to say 5 injections per day, and an arm called continuous     insulin infusion via an external pump with APIDRA®.      In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved     metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia     curve noted during the continuous glycemia recording; an improvement in quality of life     compared with treatment using multiple injections.   "
94576|NCT02048176|"     Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior     fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of mutism     1-6 days after surgery that can spontaneously improve on average from 7-8 weeks later. Few     patients recover normal speech. Most of their speech continues to be marked by dysarthria,     dysfluency and slowed rate. Researchers have not identified the pathophysiologic mechanism     for PFM nor have they found a cure. Despite the improvements in speech, patients with PFM     have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few studies     have looked at long term outcomes of patients affected by PFM. We propose to survey patients     who developed PFM after resection of a medulloblastoma to determine long term effects of PFM     on patient's quality of life.   "
94577|NCT02048163|"     The purpose of this study is to compare the incidence of nausea and vomiting following short     intermittent versus prolonged intermittent infusion of meropenem.   "
94578|NCT02048150|"     This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen     (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in     visualization of the prostate. Attaching a fluorescence, a substance that emits radiation     that is visible, to the anti-PMSA antibody and injecting it into the body may help identify     the tumor when specialized microscopes are used.   "
94579|NCT02048137|"     In the study we test whether transcranial direct current stimulation can reduce the     perception of pain in patients with chronic inflammatory bowel diseases.      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in     patients with chronic inflammatory bowel diseases.   "
94608|NCT02047760|"     There is increasing evidence that examining our eyes can tell us a lot of information about     our health, and systemic diseases. We want to study what eyes can reveal about serious     neurodegenerative diseases like multiple sclerosis, and motor neurone disease, by analysing     the retinal images from a simple non-invasive eye scan, that is already being routinely used     to provide immediate clinical information in this group of patients.   "
94580|NCT02048124|"     Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle     Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological     (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a     new needle named ProCor was developed in the hope of obtaining core samples and thus     increase diagnostic yield.      Objective: In this research project, we propose to conduct a prospective trial to compare the     results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor     needle (25gP).      EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a     randomisation sequence will set in order to determine which of the two needles will first be     used (25S or 25P).      The cytological or histological diagnoses will be made; . for histological diagnosis, the     pathologist will first establish the presence or absence of a tissue core (defined as a     measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen:     cellularity (score 1 poor; score 2 good; score 3 excellent),[14] sample bloodiness     (score 1 minimal;score 2 moderate; score 3 significant, and the presence or absence of     malignancy(positive / negative / suspicious / inconclusive).      Results for continuous variables will be summarized using mean ± SD, . and categorical     variables using proportions. The 25S and 25P groups will be compared using Chi-square test     for categorical variables and, Student t test for continuous variablesTwo-sided p values less     than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v     15.0 (SPSS Inc., Chicago IL) statistical software.   "
94581|NCT02048111|"     To evaluate the safety (acute adverse effects associated with infusions, and inhibitor     development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding and     control of hemorrhaging during prophylaxis of IB1001 in subjects with hemophilia B.   "
94582|NCT02048098|"     The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3     hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable     pregnancy   "
94593|NCT02047955|"     The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on     designated commercially available Tornier Shoulder repair products. In addition, this study     will provide performance data for use in education, marketing materials, peer-reviewed     publications and support research and development of future products.   "
94584|NCT02048072|"     This study is designed to primarily evaluate the impact of Gilenya (Fingolimod) on the     autonomic nervous system in patients being treated for the first time with Gilenya     (Fingolimod). Effects on the cardiovascular system will be studied as well. The study is     conducted to answer the question, if, and if yes, what impact the treatment with Gilenya     (Fingolimod) has on the autonomic nervous system. To our knowledge little is known about the     effects of Gilenya (Fingolimod) on the autonomic nervous system. We do know of rare, but     potentially clinically and therapeutically relevant cardiovascular adverse events of Gilenya     (Fingolimod). From a scientific point of view the mechanisms by which this is mediated are of     interest. Maybe a better understanding of these mechanisms might even be of clinical     relevance (e.g. risk stratification).      The impact of Gilenya (Fingolimod) on the autonomic nervous system is quantitavely measured,     using a state-of-the-art technique. Non-invasive blood pressure measurement is performed with     the Finometer Pro (Finapres Medical Systems, NL) under different paradigms (breathing at     rest, deep breath, valsalva maneuver, active standing). In addition the sympathetic skin     reaction is performed. The non-invasive blood pressure measurements are done by continuous,     plethysmographic blood pressure measurement at the index finger, while the patient is     performing the tasks mentioned above. By interpreting the blood pressure curve, heart rate     and blood pressure variability are calculated. The sympathetic skin reaction consists of     measuring the change of electric conductibility of the skin (palms and soles) after an     electric stimulus of a peripheral nerve. These parameters allow to assess the functionality     of four important autonomic functional systems (orthostasis, sympathetic adrenergic,     sympathetic cholinergic, parasympathetic cholinergic). Normative data has been acquired in     our lab.      Our hypothethis is, that there will be a change of heart rate variability at t4,5h compared     to baseline (t0) for the parameter RMSSD under normal breathing.   "
94585|NCT02048059|"     This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in     breast cancer patients with recurrent brain metastases.   "
94586|NCT02048046|"     Patients with heart and/or lung failure are some of the sickest patients in our hospital     systems. In severe cases they often need long periods of specialist care in Intensive Care     Units (ICU) in Australia and New Zealand. Extracorporeal Membrane Oxygenation (ECMO) is an     extremely specialised and costly form of life support, only being utilised when a patient is     close to death as a last resort to save their life. This form of life support has been used     for many years in babies and children but is relatively new for adults. Whilst there is     evidence emerging of the positive effects of ECMO in adults, there is a lot that is unknown     and further research is required.      Another essential therapy that assists patients in their recovery from illness is the     provision of artificial nutrition. This liquid formula is delivered into the stomach or as a     nutritionally rich fluid provided into the vein. Until recently nutrition was     under-emphasised in the critically ill, however, it has now become clear that targeted     nutrition can positively affect a person's outcome and is vital during long periods of     intensive care hospitalisation.      There is very limited data on how nutrition affects the outcomes of ECMO patients (positive     or negative). We know from limited studies that these patients receive less nutrition than     other patients, something that is particularly concerning given that less nutrition leads to     a longer hospital stay and has been linked a with higher hospital mortality. We also think     that adult patients on ECMO need more nutrition as they appear to lose more weight than     patients with other illnesses in intensive care; however this has not been confirmed. It is     thus essential that we understand the effects of this relatively simple but vital therapy on     these very sick patients.      This study proposes to collect information on the current feeding practices in patients on     ECMO and describe the factors that inhibit or allow provision of nutrition so that we can     understand the issues that exist, develop strategies to improve delivery of nutrition and     determine areas for further research.   "
94587|NCT02048033|"     Prospective multicenters randomized study to compare the efficiency and the socioeconomic     impact of the endoscopic management (Overstitch technique) of weight regain after gastric     bypass surgery to non invasive treatment   "
94588|NCT02048020|"     This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with     paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV     oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill     tumor cells. Giving paclitaxel and carboplatin before radiation therapy with paclitaxel may     kill more tumor cells.   "
94589|NCT02048007|"     The long-term goal of this study is to more precisely define the role of mass azithromycin     treatments as an intervention for reducing childhood morbidity and increasing growth, and for     the potential selection of antibiotic resistance. The investigators propose a set of 3     cluster-randomized trials comparing communities randomized to oral azithromycin with those     randomized to placebo. To assess the generalizability of the intervention, investigators will     monitor for antibiotic resistance, which could potentially limit adoption of mass antibiotic     treatments. The investigators will also assess several measures of infectious diseases. The     investigators hypothesize that mass azithromycin treatments will reduce childhood morbidity     and will be accompanied by an acceptable level of antibiotic resistance.   "
94590|NCT02047994|"     Currently no ideal preventive modalities are available for reducing gastric-cancer caused     mortality in organized population-based application. The primary objective of the study is to     determine if H.pylori screening followed by eradication of positive subjects and endoscopic     follow-up of those with serological evidence of atrophic gastritis reduces mortality from     gastric cancer in middle-aged people in high-risk areas. The GISTAR study is a multicenter     randomized study of H.pylori eradication and pepsinogen testing for prevention of gastric     cancer mortality. Altogether 30.000 individuals aged 40-64 years will be enrolled, providing     90% study power to detect at least 35% reduction in gastric cancer mortality at 15 years of     follow-up. Participants will be randomly allocated to one of two groups. In the active     investigation/management group those positive for H.pylori will be offered eradication     therapy and individuals with decreased pepsinogen I/II ratio will be invited for endoscopy.     The control group will receive standard health care. The primary endpoint for this trial will     be the mortality difference from gastric cancer between the two groups at 15 years or when     enough cases accumulate to demonstrate a statistical difference. The study is expected to     provide valuable information on the utility for reduction in gastric cancer mortality of: 1)     H.pylori eradication in adults on a population-basis, including subjects who may already have     pre-malignant lesions; and 2) pepsinogen testing in screening settings. A pilot study of     3,455 individuals prior to the main trial was conducted from October 2013 to December 2016.   "
94591|NCT02047981|"     Our long-term goal is to more precisely define the role of mass azithromycin treatments as an     intervention for reducing childhood mortality. We propose a single multi-site     (multi-country), cluster-randomized trial comparing communities randomized to oral     azithromycin with those randomized to placebo. We hypothesize that mass azithromycin     treatments will reduce childhood mortality.   "
94592|NCT02047968|"     The objective of the study is to examine whether a combination of wake therapy, light therapy     and sleep time stabilization as a supplement to standard treatment can reduce depressive     symptoms in patients admitted at two psychiatric wards at Aarhus University Hospital,     Risskov. Seventy-four patients will be randomized either to this intervention or to a control     group receiving treatment as usual. Furthermore, it will be examined whether the duration of     admission can be reduced in the intervention group. Finally, the aim is to identify     predictors of good effect of the intervention.   "
94594|NCT02047942|"     Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to     long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction     in subjects with cardiovascular disease. However, the majority of cardiac patients do not     engage in enough physical activity to obtain benefits or in the long-term struggle to     maintain a physically active lifestyle. There is a need for innovative rehabilitation methods     aiming at increasing longer-term adherence and hence more sustained effects on health related     physical fitness. One strategy might be the use of home-based training in combination of     telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical     trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based     rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with     telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical     fitness. It is hypothesized that patients randomized to a home-based training program with     telemonitoring guidance will demonstrate higher levels of physical activity at one year of     follow-up, resulting in higher levels of physical fitness, compared to patients who have been     enrolled to the supervised center-based cardiac rehabilitation program or control group.     Ninety patients will be randomized to Home-based training, a center-based cardiac     rehabilitation program or an advice only group (= control group). Assessment will be     performed at baseline, immediately at completion of the intervention and at one-year of     follow-up and will include measurements of exercise tolerance, cardiovascular risk factors,     physical activity, muscle strength, endothelial function, health-related quality.   "
94595|NCT02047929|"     Asthma is a common disease that affects people of all ages and has significant morbidity and     mortality. Poor outcomes and health disparities related to asthma result in part from the     difficulty of disseminating new evidence and paradigms of care delivery such as shared     decision making (SDM) into clinical practice. This study will evaluate a novel mechanism for     dissemination of an evidence-based SDM Toolkit for asthma care in primary care practices. The     study is ideally suited to study dissemination methods because it will leverage a partnership     between an established consortium of practice based research networks (PBRNs) and an advanced     Medicaid Network.      This study will evaluate a novel dissemination process (FLOW) to spread an Asthma Shared     Decision Making Toolkit to practices within a Medicaid network using a consortium of     practice-based research networks (NCNC). The knowledge gained from this proposal and the     partnerships formed between practice-based research networks and NC Medicaid will facilitate     widespread dissemination to almost 300 practices.   "
94596|NCT02047916|"     The current definitions of neonatal shock/circulatory failure are outdated and inaccurate.     This makes the development of evidence based protocols for its treatment very difficult.     Furthermore these definitions often rely on invasive methods of monitoring in patients such     as an arterial line. Since the advent of functional echocardiography in neonatology there has     been increased interest in non-invasive measurements of neonatal circulatory failure. However     research in this field has been confined to premature infants.      The purpose of the this research is to look at non invasive methods of assessing an infants     circulatory status in infants older than 33 weeks gestational age in order to fill the     knowledge gap here and help in the development a new definition of neonatal circulatory     failure.   "
94597|NCT02047903|"     This observational study will investigate the efficacy, safety, tolerability and symptom     control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally     advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the     treating physician has decided to initiate treatment with GIOTRIF in first line according to     the local label, will be followed up for approximately 24 months.   "
94598|NCT02047890|"     This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety,     tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in     Japanese subjects with advanced malignancies.   "
94609|NCT02047747|"     The purpose of this study is to determine the disease response, survival, and side effects of     an experimental drug called dacomitinib in progressive brain metastases.   "
94599|NCT02047877|"     The purpose of this study has two major goals: 1) to measure the amount of two specific     hormones interleukin (IL)-10 and interleukin (IL)-12p70 in mucous and blood; and 2) compare     the hormone levels in two specific areas of the lung called the trachea (upper airway) and     the bronchioles (lower airway). The hormones IL-10 and IL-12p70 are cytokines, special     hormones cells use to communicate with each other during inflammation or infection. Cytokines     can be measured in mucous and blood. The balance of one cytokine compared to another help     doctors to understand how people respond differently to infection. Unfortunately, the amount     of IL-10 and IL-12p70 is not known in children, especially children with a lung infection. In     addition, we do not know if the balance of these cytokines differ in various regions of the     lung. We believe the balance of IL-10 and IL-12p70 is similar whether measured in the upper     or lower airways.   "
94600|NCT02047864|"     Osteoporosis is an important health problem, costing the Canadian health care system over $2     billion per year. Loss of bone mineral and bone fragility is especially prevalent in     postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic.     Creatine monohydrate is a nutritional supplement that is often combined with strength     training to increase strength and muscle mass. The investigators recently completed a pilot     study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate     significantly improved hip bone mineral density during a 1-year resistance training program.     In our current proposal the investigators want to determine whether creatine combined with     strength training can have an even larger effect on bone mineral density at the hip if given     over 2 years in a large group of postmenopausal women (n=240). The investigators also want to     determine whether this leads to reduced fractures in these women for up to a year after     completing the creatine and strength training program.   "
94601|NCT02047851|"     The purpose of this study is to determine whether acupuncture is helpful for patients with     joint pain associated with psoriasis   "
94602|NCT02047838|"     This retrospective case-control study was performed in an Academic centre for the diagnosis     and treatment of endometriosis. It included patients with recurrent unilateral endometriomas     who were previously operated for the same condition (cases) and patients without recurrency     who previously underwent surgery for unilateral endometrioma (controls). The primary outcome     of the study was to assess the impact on ovarian reserve of second surgery for recurrent     unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum     anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta     estradiol level and antral follicle count (AFC).   "
94604|NCT02047812|"     Introduction      'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which     are known to carry a significant risk of mortality and morbidity. Previous work has shown     considerable inter-hospital variation in emergency laparotomy outcomes within the United     Kingdom. It is unknown whether there are significant differences in outcomes following     laparotomy which may be explained by differences in hospital procedural volume.      Aims      The aim of this study is to compare emergency laparotomy outcomes in Scotland as they vary by     hospital procedural volume.      Methods      This research study is a retrospective observational enquiry which will utilise     administrative data from the Information Services Division (ISD) of NHS National Services     Scotland. Patient episodes will be identified by a set of procedure codes for emergency     laparotomy.      The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary     outcome measures will be 30 day readmission rate, 30 day re-operation rate and length of     stay.   "
94605|NCT02047799|"     The prevalence and incidence of cardiovascular disease (such as Hypertension) increases     exponentially with age (McDermott, 2007;) These diseases account for 30% of the global     mortality (WHO, 2011). Vitamin D (VD) insufficiency affects as many as half of otherwise     healthy adults in developed countries (Holick, 2007). VD is implicated in the control of     blood pressure (BP) through inhibition of the renin-angiotensin system (Yamshchikov, 2009),     although the role of VD supplementation for prevention and treatment of the HTA is     controversial.The purpose of this study was to investigate if VD supplement in elderly people     reduces the levels of BP.   "
94606|NCT02047786|"     Introduction      Appendicectomy (or appendectomy in US usage) is the single most commonly performed emergency     surgical operation performed on British children. Previous investigation of outcomes     following appendicectomy has suggested that specialist surgeons and high volume centres have     fewer negative appendicectomies (i.e. the appendix found to be non-diseased), although     there has not been consistent association found between hospital type or surgeon experience     and complication rate or admission rate.      Scotland has 3 dedicated children's surgery centres but straightforward children's surgery     such as appendicectomy is also carried out in the country's general surgical centres.     Appendicectomy outcome variations have not been explored in the Scottish National Health     Service (NHS).      Aim      This study will compare appendicectomy outcomes in children between Scotland's specialist     paediatric centres and general surgical centres.      Methods      This is a retrospective study of all appendicectomies performed in Scotland during the period     from 1st January 2001 - 31st December 2010, on children aged 2 - 12 years old. It will use     routinely collected administrative data from the Information Services Division of NHS     National Services Scotland.      The study will compare risk-adjusted 30 day/in-patient mortality, 30 day re-admission rate,     30 day re-operation rate, post-operative length of stay and negative appendicectomy rates.   "
94607|NCT02047773|"     From the British Thoracic Guidelines1 and a PUBMED search there are no randomised controlled     trials exploring optimum antibiotic duration for chest infections. The standard course of     intravenous antibiotics for exacerbations of bronchiectasis is 14 days. This is a preliminary     open labelled study to assess whether it is feasible to stop treatment earlier (day 8 or day     11) if the bacterial load is low or absent at days 7 or day 10 (it takes 24 hours for the     results to be processed). All patients will therefore have a minimum of 7 days intravenous     antibiotics. The intravenous antibiotic chosen is routinely used for exacerbations in     bronchiectasis.      Our hypothesis is that patients could have personalised treatment and be able to stop     antibiotics when the sputum bacterial load is low (<10^6 colony forming units/ml (cfu/ml)).   "
94610|NCT02047734|"     The purpose of this study is to determine whether RPC1063 is effective in the treatment of     relapsing multiple sclerosis (RMS).   "
94612|NCT02047708|"     Many patients with scleroderma have damage to their kidneys caused by the disease. There is     limited evidence for treatments to prevent this damage or stop it progressing. Blocking a     substance in the blood called endothelin has helped treat some aspects of scleroderma. The     purpose of this study is to see how effective a new endothelin blocker called Zibotentan is     in treating patients who have scleroderma and have gone on to develop reduced kidney function     as a complication. It will be given in addition to the accepted treatments used for     scleroderma. There will be three parts to this study each for a different group of patients:        -  ZEBRA 1 for patients with mild or moderate kidney disease caused by scleroderma        -  ZEBRA 2A for patients with a more severe, acute form of kidney disease caused by          scleroderma (scleroderma renal crisis) who do not require dialysis        -  ZEBRA 2B for patients who have had scleroderma renal crisis and are on dialysis   "
94613|NCT02047695|"     The purpose of this study is to investigate whether a particular form of migraine, migraine     with aura, is associated with structural changes in the brain   "
94626|NCT02047526|"     This non-interventional, prospective, multi-centric, cross-sectional study is aimed to     observe clinical practice in India in managing Heart Failure patients & to check one year     outcome in HF patients. A total of 5 visits will be conducted during the study. There will be     a baseline visit followed by four follow-up visits to assess the outcomes   "
94614|NCT02047682|"     Static postures, repetitive work tasks, and work stress increase the risk for musculoskeletal     disorders and sickness absence. Objective measurements of occupational loadings - EMG for     muscular activity, EEG for cognitive activity, ECG for cardiovascular activity and heart rate     variability, actigraphy for bodily movements - may provide useful early indicators of     muscular, cognitive and cardiovascular overload.      The aim of this study is to investigate the effect of an individually tailored     bio-psycho-social intervention strategy versus usual care ergonomics and standard physical     exercises (reference group) on these risk factors in lab technicians with a history of     work-related musculoskeletal pain.   "
94615|NCT02047669|"     Musculoskeletal disorders and stress of employees remain a major problem in many occupations.     The aim of this study is to investigate the effect of an individually tailored     bio-psycho-social intervention strategy versus usual care ergonomics and standard physical     exercises (reference group) on musculoskeletal pain, work disability, and stress in lab     technicians with a history of work-related musculoskeletal pain.   "
94616|NCT02047656|"     This study is designed to enable optimal dose selection of LFF269 for potential future     studies by providing additional information about the compounds safety, tolerability,     pharmacokinetic and pharmacodynamic profiles.   "
94617|NCT02047643|"     Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of     exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D).     However, since patients with T1D often do not make exercise-related adjustments to their     insulin regimen, our group has developed an algorithm to initiate pump suspension in a     user-independent manner upon projecting exercise-associated hypoglycemia. The current study     seeks to test the efficacy of this algorithm by asking users to participate in a sports camp     while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate     monitor (to detect exercise), which will communicate electronically to a pump shutoff     algorithm. On one of the days the algorithm will be used, while on the other day their normal     insulin rate will continue for comparative purposes.      The investigators hypothesize that the use of an accelerometer-augmented computer algorithm     for insulin pump suspension during exercise will result in significantly fewer episodes of     hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without     a pump suspension algorithm.   "
94618|NCT02047630|"     The purpose of this study is to evaluate and compare efficacy and tolerability of the     brand-name latanoprost and one of its generic version in subjects with primary open angle     glaucoma or ocular hypertension.      This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are     two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one     eye and the generic version in the other one. In the second period, drops are switched from     one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0     (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of     second period). Variations of intraocular pressure in each eye will be evaluated.   "
94619|NCT02047617|"     Critically ill patients frequently develop muscle weakness due to critical illness-related     acute neuropathy and/or myopathy. This disorder is associated with difficulties in weaning     from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased     mortality rates. In addition, many patients continue to suffer from decreased exercise     capacity and quality of life for months to years after the acute event.      Besides controlling risk factors, no specific prevention or treatment exists. Recommendations     advice to start early with active and passive exercise in critically ill patients (1). Having     critically ill patients alert and engaged in progressive rehabilitation leading to     mobilization, despite the use of life support therapies may reduce muscle atrophy and lead to     improved strength and physical function (2).      This randomized controlled trial was designed to investigate whether a daily training session     using a tilt table, started early in stable critically ill patients with an expected     prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps     force and functional autonomy at ICU and hospital discharge compared to a standard     physiotherapy program.   "
94620|NCT02047604|"     A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of     Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate     Response to Disease-Modifying Anti-rheumatic Drug(s).   "
94637|NCT02047383|"     The acute respiratory infection is the fourth most common cause of hospital stay between     elderly people. The purpose of this study is to evaluate the repercussion of hospital stay in     hospitalized patients with a respiratory infection.   "
94638|NCT02047370|"     Physical therapists have traditionally included various forms of manual therapy among the     therapeutic approaches to respiratory conditions. The aim of this study was to evaluate the     effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion and     spirometric values in patients diagnosed with asthma.   "
94621|NCT02047591|"     The 3rd governmental plan of fighting against the pain favored the development and the     evaluation of the efficiency of the non pharmacological methods. Its results always showes a     lack of knowledge of these methods and the utility to pursue the researches.      In the department of pediatric surgery of the university hospital of Limoges, the     relaxing-touch is one of these methods which is more and more used. The healthcare staff     noticed the beneficial effects of such an empirical method in terms of comfort and quality of     life for the children.      In 2011, a pilot study led in this department showed that, in spite of the usual treatment,     the removal of the Redon's drain remains painful for 25 % of the children (score on the pain     scale > or = 4). This result convinced the medical team to write a protocol of research from     the following hypothesis: the implementation of a protocol of the Redon's drain removal     associated to the relaxing touch and usual treatment could lead to a decrease of the acute     pain for a 7 to 17 years old child.   "
94622|NCT02047578|"     To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan,     fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.   "
94623|NCT02047565|"     This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2     treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded),     randomized, placebo controlled, sequential descending prothrombin complex concentrate dose, 2     sequence, 2 period crossover study. In both parts of the study, the assessor of BD and BV     will remain blinded. In Part 2 of the study, both the subject and the clinic staff involved     in study conduct will be blinded (with the exception of the pharmacist or nurse who prepares     the blinded individual treatments from open-label supplies). The study programmer and     statistician will also be blinded to treatment assignment. The Sponsor will remain unblinded     for both parts of the study.   "
94624|NCT02047552|"     The purpose of this trial is to determine if the combination of goal directed iron     supplementation and hepcidin mitigation can safely eliminate both the serum and bone marrow     iron debt of anemic, critically ill trauma patients with functional iron deficiency.   "
94627|NCT02047513|"     NEONAX is an interventional, prospective, randomized, controlled, open label, two sided     survival phase II studies against a fixed survival probability, with an unconnected analysis     of the results in both experimental arms.      Determining the impact of 2 cycles of Perioperative nab-paclitaxel/gemcitabine followed by     surgery and 4 cycles of adjuvant nab-paclitaxel/gemcitabine or 6 cycles of adjuvant     nab-paclitaxel/gemcitabine on the Disease free survival (DFS) rate at 18 months post     randomization   "
94628|NCT02047500|"     This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety,     tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine     and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or     metastatic pancreatic adenocarcinoma.   "
94629|NCT02047487|"     This is a randomized, open controlled multicenter phase II clinical study. The SPSS     statistical software estimation of sample size, selection of the initial treatment of locally     advanced head and neck squamous cell carcinoma in 120 patients, such as to achieve the     desired results, considering expanding the clinical, according to the proportion of 1:1 were     randomly divided into two groups, all patients were taken, docetaxel + cisplatin 2 cycles of     induction chemotherapy 、Concurrent chemoradiotherapy（tomotherapy+cisplatin）, The experimental     group was added with AVASTIN.   "
94630|NCT02047474|"     This phase II trial studies how well combination chemotherapy before and after surgery works     in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as     leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed. Giving these treatments     after surgery may kill any tumor cells that remain after surgery.   "
94631|NCT02047461|"     This study will include a screening period, a 6-month treatment period, and a 60-month,     long-term extension period.   "
94632|NCT02047448|"     The purpose of this pilot study is to determine if medication adherence is improved by a     transitional care pharmacy practice model designed to integrate hospital and community     pharmacists in the care and education of patients with heart failure or COPD who are     discharged from a community hospital to home. The hospital and community pharmacists will     collaborate with each other, the patient, and other practitioners including the primary care     physician, nurse, and case manager to prevent and correct medication-related problems and     attempt to improve patient outcomes especially during the error-prone transition from     hospital to home.   "
94633|NCT02047435|"     Social relationships are important to people and it affects their quality of life, morbidity     and mortality.      This is a randomised controlled trial studying the effect of including older people with     impaired social relationships and a perception of loneliness at workshops, at The Storm P.     Museum - a museum about the well known Danish cartoonist Robert Storm Petersen.      The hypothesis is, that by including older lonely people with a impaired social participation     in these workshops, they will increase the participants health related quality of life. The     investigators also hypothesis, that the intervention will improve the participants perception     of loneliness, social participation and physical function.      The intervention consist of a series of workshops at the Storm P. Museum. At these workshops     the participants will create memory material for nursing home residents with dementia. The     museum staff will facilitate a process of storytelling, using events, significant stories and     artistic works by Storm P. and encourage the participants, by means of the narrative     interview method to share similar stories from their life.   "
94634|NCT02047422|"     To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure     patients   "
94635|NCT02047409|"     The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve     activity muscle is an efficient index for the prognosis of patients with heart failure.   "
94636|NCT02047396|"     To comprehensively characterize Left Ventricular (LV) remodeling after Myocardial Infarction     (MI) in the community, study the association between patterns of remodeling and biological     pathways and examine the association between the predictors of remodeling and heart failure     after Myocardial Infarction.   "
94644|NCT02047292|"     Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and     normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA)     procedure. It is recognized that increased head-neck ratio results in increased ROM due to     the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs     of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers     or sawbones) or using mathematical modeling in computer simulations. These studies are     limited by the lack of soft tissues and muscle activations in the models. This study will     clinically assess the effect of prosthetic head diameter on patient capability of performing     movements which require extreme arcs of motion of the hip joint. Therefore, the research     questions are:        -  What role do soft tissues play in limiting ROM?        -  Can prosthetic impingement really occur in a well positioned THA?        -  Can a bigger head diameter alone reduce the risk of impingement?   "
94645|NCT02047279|"     The purpose of this study is to estimate left atrial volume reduction surgery concomitant     with the maze procedure and mitral valve repair/replacement in patients with atrial     fibrillation with an enlarged left atria.   "
94646|NCT02047266|"     The purpose of this study is to compare three different revascularization strategies in     patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.      The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass     grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump     coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events     (MACCE) and procedural success.   "
94647|NCT02047253|"     This study will test how effective the drug, Carfilzomib, reduces progression of prostate     cancer in patients who have previously received chemotherapy and androgen inhibitors.     Carfilzomib is approved for multiple myeloma but is not approved for prostate cancer.     Therefore, it is considered investigational. Other approved methods of treatment for     metastatic prostate cancer have demonstrated only modest benefits. Novel and tolerable agents     are necessary to make further gains and extend overall survival.   "
94648|NCT02047240|"     We have several ways to appropriately determine renal function in healthy patients and in     several diseases, in cirrhotic population we dont have a precise tool that has sufficient     precision that reflects glomerular function, although it has been reported that cystatin C,     because of its nature could improve diagnostic accuracy to determinate the renal function in     this population.      The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived     formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99     (diethylene-triamine-pentaacetate- technetium-99) as gold standard.   "
94649|NCT02047227|"     This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to     assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone     [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular     development as part of an assisted reproductive technology (ART) treatment cycle in poor     ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of     Human Reproduction and Embryology (ESHRE) criteria.   "
94650|NCT02047214|"     The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and     efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have     glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide     (TMZ) therapy and that has progressed following prior bevacizumab therapy.   "
94651|NCT02047201|"     To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT)     based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck     squamous cell carcinoma.   "
94652|NCT02047188|"     Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular     architecture on lesion surface.The histology of early colorectal lesions could be predicted     under NBI view.However,its capability for estimating invasion depth remains to be     verified.The study is based on the hypothesis:NBI can predict histology and invasion     depth,combined with the verification of microvessel count and MMP-7 expression.   "
94653|NCT02047175|"     The purpose of this study is to evaluate the drug-drug interaction of     CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)   "
94654|NCT02047162|"     The purpose of this study is to learn whether bismuth subsalicylate can reduce use of     antibiotics among adults with diarrhea in Pakistan.   "
94655|NCT02047149|"     Prospective nonrandomized phase I study      The purpose of this study is to determine safety and efficacy of zileuton when added to     dasatinib in patients with chronic myelogenous leukemia (CML).   "
94656|NCT02047136|"     Histamine is a biologically active component that can be found in many foods and beverages.     Intake of excessive histamine from foods or beverages, can trigger symptoms including     urticaria. A low histamine diet has been recommended as one of the possible treatments for     patients with chronic urticaria. There are very few studies to confirm the effectiveness of     such diets and, to the investigators' knowledge, none from Asia where high histamine     containing meals are often eaten (personal observations). The objective of the present study     is to investigate the therapeutic effect of low histamine diet in relieving symptoms in     patients with chronic urticaria with or without angioedema, and / or pruritus (U/A/P). The     investigators hypothesize that following a low histamine diet for 4 weeks, the symptoms of     patients with chronic U/A/P should improve.   "
94668|NCT02046980|"     To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation     in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal     semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.   "
94669|NCT02046967|"     Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a     very high success rate. It works by heating and thereby obliterating the vein. Steam ablation     is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis     of this study is that steam ablation is as effective as laser ablation, but that it results     in better secondary outcomes (e.g., lower pain scores).   "
95102|NCT02041299|"     This research is being done so that we can look at the safety and efficacy of deferiprone in     people with sickle cell disease or other anemias. Deferiprone is a drug that removes iron     from the body. We will be comparing deferiprone with deferoxamine, another drug that removes     iron from the body.   "
94657|NCT02047123|"     Flax (Linum usitatissimum L.) is an economically important oilseed. Lifestyle and diet are     the first line interventions to reduce the short-term and long-term cardiovascular risk     factors. Due to its high content of lignans, α-linolenic acid (LNA) and fiber, flaxseed has a     beneficial effect on CVD risk factors, components to decrease the risk of cardiovascular     disease. Objective: To determine the effect of the consumption of flax seed yogurt on the     women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce     the small dyslipidemia. The investigators performed an intervention including 133 women (age=     25-70 years). Participants were randomly and double-blind distributed into three groups:     Group 1 (n= 30) consumed flaxseed (FS), yoghurt (Y) and diet (D), Group 2 (n= 32) volunteers     consumed (Y) + (D) and Group 3 (n=27) consumed only diet. All groups followed a limit     levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol and     triglycerides and were determined at the beginning and end of a 30-day test. As a result,     group 1 presented significantly reduced total cholesterol levels. Correlation analysis     indicated that the intake of (FS) could explain the flaxseed effect of the variation of the     cholesterol and TG in this group. Altogether, this study concludes that consumption FS exert     a positive impact in total cholesterol level and TG   "
94658|NCT02047110|"     The overall purpose of the trial is to assess the clinical efficacy of three different     subcutaneous doses of BI 655066 in adult patients with AS, in order to provide clinical proof     of concept and to select dose (s) for confirmatory clinical trials.   "
94659|NCT02047097|"     The primary objective of the study is to determine the incidence, type, and pattern of     serious adverse events (SAEs), including but not limited to infections (including     opportunistic infections), hepatic events, malignancies, and renal events, and of adverse     events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl     fumarate (DMF). Secondary objectives of this study in this population are as follows: To     determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical     practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl     fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in     routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score     and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl     fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work     productivity.   "
94660|NCT02047084|"     Given the propensity for venous leg ulcers to become refractory, long standing lesions,     incorporating active biologic grafts into the standard compression therapy, has shown to     accelerate wound healing.      The two products to be compared in this study are both commonly used for the treatment of     venous leg ulcers. Apligraf is considered a medical device by the FDA, and was cleared for     the treatment of venous leg ulcers in 1998. It is a staple for the treatment of venous leg     ulcers, and is widely used throughout the United States. It is composed of a type 1 collagen     matrix in which human foreskin-derived neonatal fibroblasts are grown, and over which human     foreskin-derived neonatal keratinocytes are then cultured and allowed to stratify.      TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem,     from an organ donor who has cleared the standard safety screenings. It is classified by the     FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA     specifications, and cryopreserved, until it is delivered to the clinic for application to the     foot ulcer. It is also a widely used treatment for diabetic foot ulcers.      TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a     substantial proportion of the population. Venous leg ulcers (VLU) account for 40-70% of lower     extremity wounds. The standard of care for treatment of VLU's in wound centers in the United     States is compression therapy combined with application of biologic graft materials to the     wound bed.      This study may assist physicians who treat VLU's by comparing efficacy and costs of two     commonly used biologic graft materials for VLU's in a randomized prospective study. In     addition to standard compression therapy, this investigation will be a head-to-head study     comparing widely used bio-engineered skin substitute (Apligraf) to cryopreserved, human skin     allograft (Theraskin). There is no randomized, prospective data comparing these two graft     options in the treatment of VLU's.   "
94661|NCT02047071|"     The purpose of this study is to determine whether Continuous Positive Airways Pressure (CPAP)     improves quality of life, cardiovascular (blood pressure) and metabolic profile (glucose and     lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea (OSA).   "
94662|NCT02047058|"     The purpose of this study is to determine whether Q cells separated from the glioma sample     are determinants in treatment response and prognosis of glioma patients   "
94663|NCT02047045|"     This trial is primarily aimed to compare the effect and safety of electro-acupuncture and     prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture     is no inferior to prucalopride? Besides, the investigators will also mainly confirm the     superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3~6     months? Then, assess the patients' acceptance of electro-acupuncture.   "
94664|NCT02047032|"     A noninferiority randomized controlled trial aimed at comparing the effect and safety of     electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed     urinary incontinence (MUI).   "
94665|NCT02047019|"     This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106     (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate     control of blood pressure with candesartane alone.      Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five     weeks of the study to assess blood pressure control with candesartan given alone.      Patients with an insufficient therapeutic response to candesartan alone (defined by mean     seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will     be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine     / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor     the treating physician will know which treatment is given (double-blinded design).This part     of the study will last eight weeks.   "
94666|NCT02047006|"     Rivaroxaban is a recently developed factor Xa (FXa) inhibitor for the prevention and     treatment of thromboembolic disease. There are no data on dose adjustments in patients with     severe chronic renal failure. It's use is therefore not recommended in this patient     population. The present study aims to asses in 12 hemodialysis patients that require     prevention of deep vein thrombosis:        1. the AUC and Cmax of 10 mg rivaroxaban        2. the effect of 10 mg rivaroxaban on coagulation assays        3. the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa          levels        4. the safety and tolerability of rivaroxaban   "
94667|NCT02046993|"     To test the hypothesis that hypertensive patients who participate in smart phone based     telemonitoring of BP will conduct more home blood pressure monitoring, better self management     behavior and greater reduction in blood pressure and better self management behaviour from     baseline to 6 months follow up than those patients receiving enhanced usual care.   "
94670|NCT02046954|"     Compromised tissue oxygenation during surgery may negatively influence patient outcome.     Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia     and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative     pericardia effusion and/or tamponade may further compromise cardiac function. Today,     hemodynamically instable patients are often monitored by means of pulmonal artery catheters     or transpulmonary thermodilution. However, these methods only allow quantification of     functional limitations. Underlying causes may be investigated by relatively recent technology     through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that     also provide the possibility of continuous monitoring. It has been reported that a training     program consisting of six hours may enable physicians who are unexperienced in the field of     echocardiography to apply this new method. Up to now, there is no evidence whether this     methods is associated with improved postoperative outcome.      Therefore we hypothesize that continuous hemodynamically focussed transesophageal     echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its     application may decrease hospital expenses (secondary hypothesis).   "
94671|NCT02046941|"     The study will use MRI brain imaging to identify brain changes associated in stroke patients     after they receive speech-language treatment for their speech difficulties.   "
94672|NCT02046928|"     This study will assess the efficacy, safety and pharmacodynamic markers of the study drug,     A6, in patients with CLL and small lymphocytic lymphoma (SLL).   "
94673|NCT02046915|"     Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens     combining novel agents and alkylating agents. However, in applying this approach the patients     are at substantial risks of a critical myelosuppression. Pomalidomide demonstrates     significant activity in combination with Dexamethasone in relapsed or refractory multiple     myeloma. This trial is an attempt to further improve the efficacy of     Pomalidomide/Dexamethasone as well as to balance efficacy and toxicity. Integration of     Cyclophosphamide in the treatment in case of suboptimal response or first evidence of     progressive disease has the aim to significantly increase duration of treatment that should     have a positive impact on PFS. It is furthermore an attempt to optimize the potential of     Pomalidomide in the antimyeloma efficacy. Based on the recent findings, that myeloma is a     disease with a wide clonal heterogeneity, combination treatment in case of suboptimal myeloma     control might lead to a more effective suppression especially of aggressive subclones and     might reduce early resistance. In addition, with the goal of keeping the individual patient     as long as possible under an effective IMiD treatment, the potential of the drug might be     optimized according to the current view of maintenance treatment resulting ideally in an     outgrowth of indolent clones in the bone marrow niche.   "
94674|NCT02046902|"     The goal of this study is to gather input from patients who have undergone PCI, their family     and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the     decision aid is to deliver information, including individualized estimates of patients'     restenosis risk, in an understandable format that would be informative and assist in     decision-making for patients undergoing PCI.   "
94675|NCT02046889|"     The objectives of this study are to 1) demonstrate the effectiveness of the innovative     bicycle training program in teaching youth with DS and ASD how to ride a standard two wheel     bike, and 2) determine the effects of the treatment on health related performance measures,     physical activity level, patterns of sleep behavior, psychosocial outcomes, and community     participation. The hypotheses to be tested in this study are: 1) there will be a significant     treatment group difference (EXP vs CON) in the number of participants who demonstrate the     ability to ride a two wheel bicycle in favor of the EXP group following the first year of     training. 2) At the end of the second year of training when the CON group receives the     bicycle training program, there will not be a group difference in the number of riders who     learned to ride. 3) At the end of the first year, there will be a significant treatment group     difference (EXP vs CON) on the health related performance measures, average time spent in     moderate and moderate to vigorous physical activity, patterns of sleep behavior (sleep onset,     frequency of night waking), self and parent perceptions of bicycle riding ability, and     community participation (number of community activities engaged in, frequency of community     participation, number of people they participate with outside of the parents, the number of     community locations in which they participate), in favor of the EXP group. 4) At the end of     the second and third year, the CON group will demonstrate a significant improvement in all of     these measures (a significant improvement from the pre-training measures to the 12 and 24     month measures). 5) At the end of the third year, the EXP group will demonstrate a     significant group difference on all measures compared to the CON group but the magnitude of     the difference will be less than was observed in hypothesis 3 at the 12 month measurement     before the CON group received their training. These hypotheses will be tested separately for     the DS and ASD groups.   "
94676|NCT02046876|"     Chronic neck pain (CNP) is defined as pain or intense discomfort in the lateral or back of     the neck with an establishment and/or persistence period of over 12 weeks.      The socio-economic system is seriously affected by chronic neck pain due to direct and     indirect costs on the health system Physical exercise is used to improve physical function     and reduce the symptoms of pain and stiffness due to chronic neck pain.      It has been demonstrated that therapeutic exercise in water is effective to improve     functional capacity and symptoms in patients with chronic neck pain. In adition, health     education and posture is an important component of the overall treatment of neck pain.      Interventions that integrate physical activity, adapted swimming and health education as an     intervention for chronic neck pain sufferers have not been found. Furthermore the aim of this     study is to analyse the effect of a physiothperapy treatment that combine adapted swimming,     therapeutic exercise and health education in patients with chronic neck pain.      Hypothesis: the present intervention will be an effective tool to treat patients suffering     chronic neck pain.      Methods: chronic neck pain patients from a community-based centre will be recruite     participate in this prospective study.      Intervention: 60 min session: 30 min of land exercise dedicated to improve mobility, motor     control, resistance and strengthening of the neck muscles, 30 min of adapted swimming with     aerobic exercise keeping neutral neck position by using a snorkel. Health education will be     provided by the physiotherapist before and during the sessions using a decalogue on chronic     neck pain and constant repetition of brief advice.      Study outcomes: disability (Neck Disability Index), physical and mental health state and     quality of life of patients (SF-12 and EuroQoL 5D respectively).      Differences between baseline data and that at the 8-week follow-up were calculated for all     outcome variables.      Statistical Analysis: descriptive statistics. Analysis of the normal distribution of the     variables using the KS-test. Comparison of variables pre - post intervencición: T-Student for     parametric variables and Wilcoxon test for non parametric variables.      Data will be analysed descriptively and for statistical significance using Statistical     Package for the Social Sciences (SPSS) (version 17.0 for Windows, Illinois, USA).   "
94677|NCT02046863|"     The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders     such as Parkinson's disease has been well established; however, there is a great disparity in     outcomes among DBS recipients due to varied postoperative management, particularly concerning     the choosing of an optimal set of programming parameters from the thousands of possible     combinations. This study will evaluate the use of motion sensor based assessments to develop     a functional map and algorithms to automatically determine a set of programming parameters     that maximize symptomatic benefits while minimizing side effects and battery consumption.   "
94678|NCT02046850|"     Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244;     ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers   "
95103|NCT02041286|"     The purpose of this study is to determine if subjects who have diabetes can operate the     Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid     glucose results.   "
94679|NCT02046837|"     Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive     androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but     has many side effects. Researchers have shown that exercise, specifically one-on-one     supervised exercise improves many of the side effects of ADT. However, exercise programs for     men on ADT are not widely available. More questions need to be answered in order for exercise     programs to become part of PC treatment. First, can programs that require fewer resources,     such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do     exercise-related benefits continue beyond the structured exercise program? And what makes     people continue exercising? Third, which exercise program is most cost-effective?      In this study, the investigators will compare: (a) group supervised in-centre; (b) home-based     supported; and (c) 1:1 supervised in-centre exercise programs to see which program is most     effective for men with PC on ADT. The investigators will also look at what motivates people     to continue to exercise both during a structured program and after the program is complete     and will examine which exercise program is most cost-effective.      The investigators will ask men with PC on ADT that are being treated at either Princess     Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in     the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3     exercise programs. All programs will include the same type of exercises (aerobic, resistance     and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day     (as tolerated) for the length of the program (6 months). The investigators will look at how     men with PC on ADT respond to the exercise program by measuring quality of life (QOL),     fatigue and different physical measures before, during, and after the exercise program.      Although the investigators know that supervised one-on-one exercise is most effective at     improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial     and more financially responsible. This study will allow the investigators to begin to answer     these questions so that structured exercise programs become a regular part of PC treatment.   "
94680|NCT02046824|"     Cell savers are routinely used in our hospital during off-pump coronary artery bypass     grafting to retrieve and wash blood that is lost during the operation. This washed blood is     retransfused to the patient in order to prevent allogeneic blood transfusion. However, little     is known about the rheologic properties and oxygen transport capacity of the washed red blood     cells and the effects of retransfusion of this blood on microcirculatory blood flow and organ     damage in the patient. For cell savers 3 different operating principles exist. The most     common one uses discontinuous blood washing with a spinning bowl that is intermittently     filled with blood, processed and emptied. A second one uses a continuous blood washing     principle with a rotational disk. A third one is intermediate using features of both the     discontinuous bowl technology and the continuous rotational disc technology.      The investigator hypothesize that the operating principle has effects on the rheologic     properties and oxygen transport capacity of the washed blood.      Previous research suggested that in particular the deformability and oxygen carrier     properties of the red blood cells are affected. As a consequence, red blood cells may block     small blood vessels, which affects microcirculatory blood flow and tissue oxygenation. This     may lead to organ damage.   "
94681|NCT02046811|"     The objective of this study is to determine the impact of a 12-month patient activation and     education intervention on skin cancer early detection practices among childhood cancer     survivors treated with radiation. This randomized controlled trial uses a three-group design.      Our specific aims are to: (1) Determine the impact of a Patient Activation and Education     intervention with and without physician activation and teledermatology on skin cancer early     detection practices, (2) Determine the impact of the intervention on time to diagnosis, and     (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.   "
94682|NCT02046798|"     This study measures how much of the trial drug enters the body and how long it takes for the     body to remove it via the feces and urine. In addition, the different breakdown products     after a single oral dose of radio-active ASP3652 will be identified.   "
94683|NCT02046785|"     The purpose of this study is to determine whether hemodynamic measures vary in angles bedside     before and after volume challenge.   "
94684|NCT02046772|"     A single blind, randomized, with blinded evaluation by third parties clinical trial is     carried out to assess the analgesic efficay of the addition of morphine chloride to a low     dose solution of spinal local anaesthetic compared to a standard dose spinal anaesthetic in     the haemorrhoid surgery.      The objective of this clinical trial is to assess if the experimental treatment is as     efficacy as the standard treatment in the anesthetic and analgesic effects with less side     effects, greater and earlier mobility after surgery and shortened the hospitalization.   "
94685|NCT02046759|"     The aim of the study is to compare the effect of asthma care by clinical pharmacist     intervention versus routine care on asthma control.   "
94687|NCT02046733|"     Despite the fact that the majority of the patients with limited disease SCLC will respond     very well to the standard treatment, a great proportion will relapse within 12 - 24 months.      Several studies in patients with lung cancer suggested a possible favourable association     between the increased presence of immunologically active cells in the tumour and survival.     Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy     cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have     shown activity in a broad range of cancers, including SCLC.      The aim of the current study is to investigate the efficacy (how well the treatment works)     and tolerability (how severe the side effects are) of the standard treatment (chemotherapy     and radiotherapy) alone, compared with the standard treatment followed by nivolumab and     ipilimumab in patients with limited SCLC.   "
94718|NCT02046330|"     We propose a clinical study of medial forebrain bundle DBS as a treatment in 10 patients with     treatment refractory depression (TRD). Data from the University of Bonn indicates that     surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients     with depressive disorders, and suggest that DBS at the same site may also reduce     symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the     US population and of those at least 10-15% do not benefit from therapies hence why we must     explore new treatments. The Activa® systems manufactured by Medtronic Neurological will be     used in this study. Study subjects will be between the ages of 22 and 65 years of age and     suffer from TRD, have failed multiple treatment regimens, including ECT, and remain     symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study     investigating DBS, targeting the MFB.   "
94759|NCT02045797|"     GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II     Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study     designed to select the optimal dose by further characterizing the safety, tolerability and PK     of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care to     treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure     infections (ABSSSI). The selected dose will be used in future studies.   "
94688|NCT02046720|"     The bispectral index (BIS) is commonly used in anesthesia to evaluate the depth of sedation.     Numerous studies in adults have shown good correlation between bispectral index values and     depth of sedation regardless of the hypnotic drug used. Requirements of intravenous and     inhalational hypnotic agents to suppress consciousness decrease with age. A study showed that     the loss of consciousness (LOC) was obtained with lower concentrations of sevoflurane in     elderly than in young adults, but at identical BIS values, so that BIS would predict depth of     sedation better than drug monitoring. This result incited the use of bispectral index     monitoring to overcome the significant pharmacological variability, especially in elderly.     Nevertheless, another research with a comparable methodology during propofol-induced     anaesthesia provided higher BIS values at LOC in elderly compared to younger patients. In     these two trials, LOC was defined differently: either by absence of verbal response     corresponding to loss of eyelash reflex (LOER) or by absence of response to prodding [(OAA/S)     <2)]. Otherwise electromyographic activity (EMG) was not taken in account. As high EMG level     (greater than 50 decibels) could create subtle artifact signal pollution without necessarily     being displayed as artifacts, this would be misinterpreted by the BIS algorithm as EEG     activity and assigned a spuriously increased BIS value.      The main objective of our study was to specifically evaluate BIS values according to age     during propofol-induced sedation. LOC was measured by obtaining an OAA/S score <2 (OAA/S2),     or a deeper sedation criterion: loss of eyelash reflex (LOER). The secondary objective was to     specify the influence of EMG on the displayed BIS values and its age-related modifications.   "
94689|NCT02046707|"     This is a single-centre open randomized parallel-group study. Patients will be selected at     random to be included in group 1: eccentric rehabilitation or group 2: conventional     rehabilitation.      In addition, a group of healthy volunteers aged between 20 and 85 years will also be     recruited. This group will make it possible to evaluate, during the two exercise sessions,     mechanisms of adaptation linked to eccentric exercise vs concentric exercise.   "
94690|NCT02046694|"     This research is being done to determine if allopurinol can change the metabolism of the oral     chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute lymphoblastic     leukemia (ALL). 6-MP is originally started at a standard dose in children with ALL, but the     dose is adjusted according to the absolute neutrophil count (ANC). Occasionally, 6-MP doses     need to be increased in order to get the ANC into a specific target range. Also, increasing     the 6-MP dose can lead to unwanted side effects, such as inflammation of the liver as shown     by increases in laboratory values (ALT, aspartate aminotransferase (AST), bilirubin), nausea,     and abdominal discomfort. Previous studies in children with inflammatory bowel disease has     shown that combining allopurinol with 6-MP can decrease side effects associated with high     doses of 6-MP and also increase the efficacy of 6-MP. Allopurinol is approved by the Food and     Drug Administration for the treatment of tumor lysis syndrome in ALL. Through this research     study, we hope to show that the combination of allopurinol and 6-MP will be safe, tolerable,     and effective in children with ALL.   "
94691|NCT02046681|"     Half of the people over the age of 65 are not functioning at their optimal level because of     interference from pain. > 50% of older adults had taken prescriptions of pain medication     beyond a 6-month period. In Emergency Department 80% of visits involving conditions with     painful component. The study aims to observe and check side effects of most frequently pain     killers prescribing at home to patients over 65 years old after a visit in emergency     department.   "
94692|NCT02046668|"     This pilot study will obtain preliminary evidence on which to base sample size calculations     for a future trial of whether spironolactone (an aldosterone blocker) reduces knee pain in     older people with symptomatic OA knee when given in addition to usual analgesia. Aldosterone     is known to be pro-inflammatory, and spironolactone suppresses cytokine production in chronic     arthritis. This application builds on previous work by the applicants showing that     spironolactone significantly improved quality of life (particularly pain) in frail older     people. The investigators will recruit 86 people (aged 70 years or over) with well-defined OA     knee to 25mg spironolactone daily or to matching placebo for 12 weeks. The primary outcome is     the between group difference in change in WOMAC pain sub-score at 12 weeks. Secondary     outcomes are the WOMAC stiffness and physical function subscales and health related quality     of life (EQ-5D). Morning cortisol levels will be measured to assess the effect of     mineralocorticoid receptor blockade on glucocorticoid levels, which may mediate the     anti-inflammatory effect of spironolactone; and urinary CTX-II, and serum matrix     metalloproteinase-3 (MMP-3) will be measured as biomarkers as both are sensitive to the     effects of pharmacological interventions for osteoarthritis.   "
94693|NCT02046655|"     Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily     recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the     higher circulating FSH activity during the first days of stimulation. For this reason, the     use of corifollitropin alfa might be beneficial in poor responders in whom the number of     oocytes retrieved is crucial for success.      The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment     compared to daily recFSH in terms of the number of oocytes retrieved in a defined population     of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using     gonadotrophin releasing hormone (GnRH) antagonists.   "
94719|NCT02046317|"     For bone fracture injuries, particularly femur fractures, the femoral nerve block (FNB) can     provide a fast and effective means to control pain. However, this method is not always     employed due to the fact that positioning the needle and therefore the block can be time     consuming and challenging, and if not precisely placed, the nerve block results in poor pain     control. Traditional methods for nerve blockade include the blind technique and use of a     peripheral nerve stimulator (PNS). Unfortunately, neither of these methods provide a reliable     guide for needle placement and can lead to intraneural placement and/or failed attempts.      Hypothesis: When ultrasound technology is implemented in this procedure it may improve the     success rate when compared to other techniques by providing real-time visual guidance. This     may result in a faster and prolonged pain relief reducing the amount of analgesics needed.   "
94720|NCT02046304|"     The goal of this clinical research study is to find the highest safe dose of gemcitabine that     can be given with radiotherapy before surgery to treat sarcoma. This study will also look at     how well this treatment controls sarcoma.   "
94694|NCT02046642|"     Maternal rest in left lateral decubitus position increases fetal urine production rate which     in turn increases the estimated amniotic fluid volume (AFV) in uncomplicated pregnancies. The     estimated AFV increases faster at initial periods, particularly during the first, second and     third 15 minute periods of the maternal rest in the left lateral position. Although at each     successive 15 minute period the estimated AFV continues to increase, the increase rate is     always less in the following period. The AFV increase curve resembles the characteristics of     a saturation curve and finally the estimated AFV increase stops approximately at the second     hour.      Although maternal rest in left lateral decubitus position increased the estimated AFV in the     previous studies, the sole effect of left lateral position or the sole effect of rest was not     evaluated, and the results of resting in another position is not known. In addition, it is     hard for a pregnant woman to maintain the left lateral position continuously.      Rest in the prone position is not practical for a pregnant woman, particularly after the     first trimester of the pregnancy and supine position may cause several hypotension related     symptoms including nausea, anxiety, lightheadedness, shortness of breath, perspiration,     tachycardia and urge to change position. Thus, right lateral position may be an alternative.      The purpose of this study is to analyze the effect of maternal rest in the right lateral     decubitus position on estimated amniotic fluid volume in comparison with the left lateral     position. Because, in both groups the mothers rested, our secondary aim was to obtain data     for the contribution of maternal rest to the AFI increase observed in the previous studies.   "
94695|NCT02046629|"     Primary Objective:      To assess the pharmacokinetic (PK) parameters of teriflunomide after a single oral dose of 14     mg administration in Chinese healthy subjects      Secondary Objective:      To assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in     Chinese healthy subjects   "
94696|NCT02046616|"     This open-label, single-arm study will evaluate the safety, efficacy, and tolerability of     subcutaneously administered RoActemra/Actemra (tocilizumab) in monotherapy or in combination     with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs)     in patients with active rheumatoid arthritis who are naïve to RoActemra/Actemra. Patients     will receive RoActemra/Actemra 162 mg subcutaneously weekly for 24 weeks.   "
94697|NCT02046603|"     This open-label study will evaluate the efficacy and safety of RoActemra/Actemra     (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs     in patients with active rheumatoid arthritis and an inadequate response to to current     non-biologic DMARD therapy or the first anti-TNF agent. Patients will receive     RoActemra/Actemra 162 mg subcutaneously weekly for 52 weeks.   "
94698|NCT02046590|"     There is a worldwide trend to minimally invasive interventions, which results in increasing     numbers of interventions performed outside of the operating room. Currently, approximately 12     to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this     anaesthetic activity is increasing.      Many of these interventions need supplementary comfort measures to have relaxed patients and     high success rates. Endoscopic retrograde cholangio-pancreatography (ERCP) is performed     >50,000 times per year in the U.S.,and is a typical minimally invasive intervention that     needs patient sedation.      There is a controversy about the optimal comfort intervention in minimally invasive     interventions and in particular in ERCP. Two different approaches to insure patients' comfort     have been proposed: general anaesthesia with endotracheal intubation and mechanical     ventilation or sedation with spontaneous ventilation.      Well-performed studies on sedation versus general anaesthesia using a randomized controlled     trial design with observer blinding will contribute to improve the decision-making for the     optimal comfort measures in minimally invasive procedures. At our knowledge such a randomized     controlled trial has not been reported before. The investigators hypothesize that deep     sedation without tracheal intubation will achieve similar success rates for ERCP as general     anaesthesia and will have similar rates of harmful postoperative effects.      The primary aim of this trial is to demonstrate that the success rate of ERCP is not inferior     in patients randomized to deep sedation without orotracheal intubation vs general anesthesia     with orotracheal intubation. Secondary aims include a comparison between randomization groups     of patient safety, patient and endoscopist satisfaction, duration of patient recovery and of     anesthesia procedure.   "
94699|NCT02046577|"     The main purpose of this study is to determine whether weekly oral vitamin D supplementation     is effective to prevent acute respiratory tract infections in children. The hypothesis of the     study is that vitamin D supplementation reduces the incidence and severity of acute     respiratory tract infections in children.   "
94700|NCT02046564|"     To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination)     compared to sertraline monotherapy in patients with major depressive disorders who have     responded incompletely to sertraline monotherapy.   "
94701|NCT02046551|"     The purpose of this study is to evaluate atomoxetine's effects on the rewarding and     reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise     healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the     negative effects of nicotine.   "
94702|NCT02046538|"     The purpose of this study is to establish the safety of Zaltrap in patients who undergo     pre-operative chemotherapy with Zaltrap. The investigators hypothesize that Zaltrap my impact     colorectal cancer growth and metastasis.   "
94703|NCT02046525|"     Ten healthy volunteers will be recruited to receive either an autologous stool transplant or     a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly,     and safely, restore a patient's fecal microbiome after antimicrobial exposure.   "
94704|NCT02046512|"     The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus     GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in     patients on broad spectrum antimicrobials.   "
94705|NCT02046499|"     This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the     prevention of post partum haemorrhage in patients undergoing caesarean section   "
94721|NCT02046291|"     This is a single institution, phase I dose escalation study of weekly romiplostim post     umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by     day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive     measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose     as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8,     and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim     determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to     identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20%     or less.   "
94722|NCT02046278|"     A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the     anal verge.   "
94760|NCT02045784|"     The objective of this study is to define the amount of dietary iodine needed per day during     the first six months of life. The hypothesis is that the current recommended iodine intake in     infants is set too high.   "
94706|NCT02046486|"     This is a single-center, prospective, randomized, single-blind, investigator initiated,     pharmacokinetic/pharmacodynamic study of parallel design.Patients with ST elevation     myocardial infarction (symptom onset<12 hours), undergoing primary percutaneous coronary     intervention, who are P2Y12 inhibitor naïve, will be randomized after informed consent,     immediately after diagnostic coronary angiography, in a 1:1 ratio to either:        -  Ticagrelor 180mg loading dose, in the form of 2 whole tablets administered per os in the          supine position (standard administration)        -  Ticagrelor 180mg loading dose, in the form of 2 tablets crushed and dispersed in          purified water and administered per os with 1-minute-stay in a 60-70 degrees          semi-upright sitting position Platelet reactivity assessment will be performed at          randomization (Hour 0) and at 0.5, 1, 2, 4 and 6 hours after randomization, using the          VerifyNow assay, in platelet reactivity units (PRU). The cutoff >208 PRU will be used          for definition of high platelet reactivity (HPR). All platelet reactivity assessments          will be performed by a physician blind to the actual treatment given. Additional blood          samples will be collected at the same time points for pharmacokinetic analysis. These          samples will be collected in vacuum tubes with lithium heparin and will be kept in ice          until centrifugation (3000 rpm at 4°C for 10 min, within 30 min of sampling). The          resultant plasma will be transferred into a plain polypropylene tube (screw cap) and          stored at or below -20°C until analysed.   "
94707|NCT02046473|"     To determine if ultrasound measurements can accurately measure the blood pressure of flow     across a stent that has been placed in a portal vein to reduce portal vein pressure known as     Transjugular Intrahepatic Porto-Systemic shunts or TIPS.   "
94708|NCT02046460|"     The primary objective is to demonstrate the non-inferiority of treatment with ASA to     anti-coagulant treatment with vitamin K antagonists in patients after a cervical artery     dissection (CAD).   "
94709|NCT02046447|"     The main purpose of this study is to investigate primary cervical dystonia as compared to     healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by     examining cognitive measures, physical measures, and structural and functional magnetic     resonance imaging (MRI).      The secondary aim of this study is to investigate a specific drug therapy for primary     cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug,     trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by     physicians as a treatment for symptoms of primary cervical dystonia.   "
94710|NCT02046434|"     This is a Phase I clinical trial of the FDA approved drug Glycerol Phenylbutyrate to see if     phenylbutyrate can increase the removal of alpha-synuclein from the brain into the     bloodstream. Alpha-synuclein forms abnormal protein deposits in dopamine neurons and is     believed to cause the death of brain cells, leading to Parkinson's Disease.   "
94711|NCT02046421|"     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and     mifepristone when given together with carboplatin in treating patients with breast cancer     that is metastatic or cannot be removed by surgery or recurrent or persistent ovarian     epithelial, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as     carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Steroid hormones can     cause the growth of cancer cells. Hormone therapy using mifepristone may fight breast and     ovarian cancer by lowering the amount of steroid hormone the body makes. Giving carboplatin     and gemcitabine hydrochloride together with mifepristone may be an effective treatment for     breast, ovarian epithelial, fallopian tube, or primary peritoneal cancer.   "
94712|NCT02046408|"     This study tests the use of handheld computer tablets to promote the integration of 5A's     (Ask, Advise, Assess, Assist, Arrange) for smoking cessation in academic and community     primary care clinics. Although most patients receive the ask and advise steps, only     slightly more than half are assessed for readiness to change, less than half receive     assistance in changing, and only 9% have an arranged follow-up. While the large majority     of primary care providers support the 5A's model, negative attitudes and the lack of time,     knowledge, and cessation skills are common obstacles. Alternate service delivery systems that     address these obstacles and evidence-based strategies to promote their implementation are     needed to improve provider adherence and 5A's fidelity.   "
94713|NCT02046395|"     The purpose of this study is to study the effect of blocking the renin angiotensin system on     urinary free light chain excretion as compared to urine microalbumin creatinine ratio in     subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a     biomarker of earlier detection of kidney function impairment in subjects with diabetes     mellitus.   "
94714|NCT02046382|"     This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen     among cesarean section patients. The study hopes to find out if patients who receive     scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain     scores and use less narcotic pain medication than patients who do not receive IV     acetaminophen.   "
94715|NCT02046369|"     A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and     adolescents with bipolar I depression   "
94716|NCT02046356|"     The investigators aim to investigate the related risk factors and the independent risk     factors of early recurrence, the rate of disease free survival and the rate of recurrence,     furthermore, develop a rating system of risk factors.   "
94717|NCT02046343|"     The purpose of this study it to determine if a promotora-led intervention that takes a     comprehensive, multi-level, community-based approach to promoting physical activity (PA) is     effective among a particularly underserved segment of Latinas. We hypothesize that Latinas in     the promotora-led PA Intervention will significantly increase minutes per week of     moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control     group.   "
94723|NCT02046265|"     The project is a clinical behavioral research project based at University of Pennsylvania.     The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and     theory-based health promotion intervention to enhance cervical cancer prevention among young     women ages 18-26 living in economically disadvantaged urban communities. The investigators     will evaluate the intervention for feasibility, acceptability and preliminary efficacy.   "
94724|NCT02046252|"     Substance use, particularly the compulsive behaviors associated with addiction, lead to     unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment     failure. High on the list of disorders leading to non-adherence is heroin addiction as a wide     range of impulsive, high-risk behaviors accompanies it. The science of adherence would be     improved by developing new methods to prevent relapse to heroin addiction, especially methods     that can be used in settings that are not limited by the aims to test such a method using an     implantable naltrexone formulation (IN) that is approved in Russia and blocks opioid effects     for 3 months. The efficacy of the IN should be better than oral naltrexone (ON) because it     does not depend on daily behavior to take a tablet and maintains a constant plasma level for     months, which should result in sustained blockade, less relapse, and better ART adherence and     treatment response.   "
94725|NCT02046239|"     Closure of the skin after liver resection (surgery to remove part of the liver) may be     achieved by one of several methods. The standard method at our institution is to use     stainless steel staples to adjoin the two sides of skin. Alternatively, a continuous     absorbable suture may be used to sew the skin together.      The ideal method of closure should be safe, effective, associated with minimal patient     discomfort and have a good cosmetic result. At present, there is no scientific evidence to     describe which method is most suitable following liver resection.      The primary aims of this study is to investigate which method (subcuticular sutures vs     staples) offers the best result in postoperative rate of (1) skin infection, (2) skin     dehiscience (separation of skin) and (3) time taken to perform skin closure. In addition, we     are interested in which method is best for patient satisfaction and cosmetic appearance and     which method is most cost effective.   "
94726|NCT02046226|"     A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen     Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.   "
94727|NCT02046213|"     The purpose of this study is to determine the metabolism and excretion of [14C]E2006 in     healthy male subjects.   "
94728|NCT02046200|"     Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the     development of effective treatments for AUDs represents an important public health objective.     Repositioning, i.e. using existing approved drugs for other indications, represents a fast     and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved     antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting     that it may be useful in the treatment of AUDs in humans. The goal of this project is to     provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to     treat AUDs.   "
94729|NCT02046187|"     This study aims to see if reducing blood sugar and increasing ketones (a metabolic product     that comes from using fats for energy) can increase survival and enhance the the effects of     standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM).     These changes occur from use of a ketogenic diet. This research has 2 goals:        1. Show that patients can tolerate the diet and maintain low blood glucose and high blood          ketone levels.        2. Show if this diet enhances the effectiveness of standard treatment by prolonging          survival of patients with a GBM.   "
94730|NCT02046174|"     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for     patients with advanced colorectal cancer that no longer responds to standard therapies.      The treatment is being evaluated for its effect on tumor growth. It consists of the placement     (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or     stop the growth of tumors in experimental animals and veterinary patients. It has been tested     in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II     studies in patients with colorectal, pancreatic or prostate cancers are in progress   "
94731|NCT02046161|"     The quality of colon preparation plays a crucial role in colon cancer prevention, especially     for right side colon. So far, colon cleansing is still not adequate in up to 10-30%     colonoscopies and leads to increase risk of missed neoplasm.Recent literature on colonoscopy     preparation revealed the dosage, timing and dietary restriction could influence colon     preparation quality. Previous study demonstrated colon cleansing on the day of colonoscopy     had better cleansing quality. However, the ideal colon preparation is not yet determined. the     investigators herein consider the in-hospital setting of colon cleansing room can ensure     better colon cleansing timing, colon preparation evaluation reliability and patient's     compliance of colon cleansing. Therefore, the investigators design a prospective randomized     controlled trial to compare cleansing quality between the setting of colon cleansing room and     the standard colon preparation.   "
94732|NCT02046148|"     Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in     healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific     antibodies in infants, placental transfer from the pregnant women to the infant and levels of     antibodies in the breast milk.   "
94733|NCT02046135|"     The proposed study will investigate the effect of sodium bicarbonate on the prevention of     acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The     investigators hypothesize that the occurrence of acute kidney injury will be less in children     treated with sodium bicarbonate in the perioperative period when compared to placebo. The     specific aims of this proposal are as follows:      1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in     pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate     on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether     treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid     balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To     determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.   "
94757|NCT02045823|"     To demonstrate clinical substantial equivalence of 3D OCT-1 Maestro as comparable to the     commercially available iVue and NW-300. Also, to demonstrate clinical substantial equivalence     of 3D OCT-2000 Maestro as comparable to the commercially available NW-300.   "
94758|NCT02045810|"     Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption.     It has not been tested on small children. The aim of this study is to measure, whether there     is a difference in nosiception measured by SPI in a group receiving local anesthetics prior     to operation compared to group receiving plasebo.   "
94734|NCT02046122|"     The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from     HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease     (GVHD) or increased treatment-related mortality. The Investigator further believes that this     will improve outcomes of elderly patients with high-risk AML or MDS compared to chemotherapy     alone, and that that this benefit will be even greater in donor-recipient pairs that share     maternal-fetal microchimerism or non-inherited maternal antigen (NIMA) mismatch. A large part     of this trial will include immune function assays as well as assessments of efficacy,     toxicity, and GVHD. Because this therapy may be a tolerable alternative to allogeneic     hematopoietic stem cell transplantation (alloHSCT) for elderly patients, the Investigator     will validate functional measurements (e.g. Comprehensive Geriatric Assessment (CGA)) with     biologic correlates (cytokine and genomic profiles) and clinical outcomes.   "
94735|NCT02046109|"     The objective of this trial is to compare the success (as assessed by a pre-defined set of     outcome) of failing composite resin restorations that are repaired using diamond bur induced     surface abrasion, to those that are completely replaced.      It is hypothesized that both treatment will have comparable success rate.   "
94736|NCT02046096|"     This prospective, multicenter, single-arm clinical study will further evaluate the safety and     effectiveness of Cook's permanent and retrievable inferior vena cava (IVC) filters     (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in     patients in need of temporary or permanent IVC filter placement for the prevention of     pulmonary embolism.   "
94737|NCT02046083|"     The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction     of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the     interest of a prolonged maintenance therapy   "
94738|NCT02046070|"     This is a phase 2, multicenter, open-label study in patients with Newly Diagnosed Multiple     Myeloma (NDMM) who have not received prior systemic treatment for multiple myeloma (MM) and     who are ineligible for high-dose therapy (HDT)-stem cell transplantation (SCT) due to age     (ie, ≥ 65 years) or comorbid disease(s) or with Relapsed and/or Refractory Multiple Myeloma     (RRMM)).   "
94739|NCT02046057|"     The purpose of the study is to determine if it is possible to identify and perform a needle     biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in     the lymph nodes under the arm without making an operation necessary.      The rationale for this study is that for patients without enlarged lymph nodes under the arm,     sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to     the lymph nodes under the arm. While the complications from a sentinel lymph node dissection     are less than that of a complete axillary lymph node dissection, sentinel lymph node     dissection still carries small risks of arm swelling, decreased movement, fluid collections,     nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do not contain     cancer. The investigators hope to develop a method to find cancer in the axillary lymph nodes     and avoid the complications of an operation.   "
94740|NCT02046044|"     Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure     patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70     beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.   "
94741|NCT02046031|"     To explore the rule of absorption, distribution, metabolism and elimination after intravenous     administration of Ginkgolides Meglumine Injection healthy subjects. The plasma drug profiles     will be important to assess the potential clinical drug-drug interactions.   "
94742|NCT02046018|"     In Sub-Saharan Africa (SSA), many children die from diarrhoea, acute respiratory illness     (ARI) and malaria, despite well- recognized, inexpensive and highly effective treatments,     since health access and human resources are limited. Healthy Child Uganda (HCU) is a     Ugandan-Canadian partnership that since 2003, has developed, implemented and evaluated a     Village Health Volunteer (VHV) program in 175 rural villages. Volunteers, selected by peers,     provide health education and refer sick children. Volunteer retention (94%) and significant     decreases in child deaths are remarkable. Now, HCU wonders whether VHV scope can extend to     provide treatment for sick children using Oral Rehydration Salts (ORS)/Zinc, antibiotics, and     antimalarials. Use of lay providers in this capacity, called integrated community case     management (iCCM), has been proposed as a potential inexpensive solution to SSA's human     health resource crisis.      PRIMARY QUESTION: In rural southwest Uganda, can iCCM provided by lay volunteers, improve the     proportion of children with diarrhoea receiving ORS/Zn, ARI receiving antibiotics, and     fever/malaria receiving antimalarials? Secondary study questions consider VHV capacity to     prescribe appropriate drug, dose, duration; iCCM acceptance by family, and VHV; VHV     retention/motivation; program cost. Selected VHV will be iCCM trained then receive treatments     for distribution. Qualitative and quantitative methods including household surveys, and focus     groups will consider pre/post intervention differences and differences in control and     intervention populations. A research short course and micro research grants (~ $3000 to     multidisciplinary groups pursuing relevant questions) will promote health system evaluation     capacity. Lessons learned are critical as SSA countries move forward in planning for     increased iCCM programming.   "
94743|NCT02046005|"     The purpose of this study is to understand how personalized risk factors for rheumatoid     arthritis (RA) may impact willingness to change behaviors associated with RA. The     investigators have developed a personalized risk estimator for RA based on demographics,     family history, biomarkers and behaviors related to RA risk. Eligible participants have a     first degree relative with RA but do not have RA themselves. Participants who meet     eligibility and consent to the study will be randomized to receive either standard     information about RA, the online personalized RA risk tool, or the online personalized RA     risk tool with guidance from a health educator. Participants will be followed to measure     willingness to change RA risk behaviors. The investigators hypothesize that participants who     receive the online personalized RA risk tool and health education will be more willing to     change RA risk behaviors compared to participants that receive standard RA information.   "
94773|NCT02045615|"     The purpose of this study is to make clear how difficult it is to remove osteosynthesis     materials afterwards, so surgeons will think twice before inserting intramedullary nails.     Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has     become.   "
94744|NCT02045992|"     Heart failure patients represent a group of individuals at higher risk for cardiac     arrhythmias. There is a perception that caffeine consumption may represent an increase in     this risk. Although the medical staff and health professionals suggest a reduction in the     intake of this substance to patients considered at risk, there is no scientific proof for     this recommendation.      Some animal studies suggest a possible association between arrhythmias and caffeine use with     higher doses, but this finding did not appear in human studies. In particular, little is     known about the association between caffeine consumption and arrhythmias in patients with     heart failure, especially at higher doses of consumption.      More specific and safe guidelines on caffeine consumption are needed.   "
94745|NCT02045979|"     Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish     pharmacokinetic similarity of BI 695501 to adalimumab.   "
94746|NCT02045966|"     The primary purpose of this study is to assess the effect of the     Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the     pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess the     effect of the DCV 3DAA FDC [DCV 3DAA FDC = fixed dose combination formulation of 3     direct-acting antivirals (3DAA) (DCV 30 mg, ASV 200 mg, and BMS-791325 75 mg)] + BMS-791325     75-mg single-agent tablet on the Pharmacokinetic (PK) of the cocktail CYP and transporter     probe substrates.   "
94747|NCT02045953|"     The VENTOLIN Mini-Spacer is being developed in order to support patients in the Emerging     Markets and Asia Pacific regions who do not have access to affordable spacers. The aim of     this exploratory study is to investigate whether the systemic exposure for fluticasone     propionate (FP) and salmeterol observed with the VENTOLIN Mini-Spacer is comparable to the     systemic exposure for FP and salmeterol observed with the Trudell Aerochamber Plus spacer for     both FLIXOTIDE and SERETIDE Metered Dose Inhaler (MDI) products. There will be four study     periods in the study and all participants will receive four study treatments during the     study. The total duration of study including screening, treatment period, washout period, and     follow-up period will be 58 days. Study is planned to enroll 20 healthy subjects.      VENTOLIN is a registered trademark of GlaxoSmithKline. FLIXOTIDE is a registered trademark of     GlaxoSmithKline. SERETIDE is a registered trademark of GlaxoSmithKline.   "
94748|NCT02045940|"     This study is the first administration of GSK2881078 to humans. The intention of this study     is to provide sufficient confidence in the safety of the molecule to inform progression to     further repeat dose and proof of concept studies. This study will include approximately 52     subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess     the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of     GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5)     will include three cohorts of 12 healthy male subjects to examine the safety, tolerability,     PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total duration     of the study including screening and follow-up, is not expected to exceed 70 days.   "
94749|NCT02045927|"     This study looks to assess whether monitoring sedation status in mechanically-ventilated     Medical Surgical Intensive Care Unit (MSICU) patients using Bispectral index (BIS)     monitor-augmented sedation monitoring as opposed to Richmond Agitation Sedation Scale (RASS)     score is associated with decreased duration of mechanical ventilation.      Investigators hypothesize that using BIS monitors to help monitor depth of sedation in     mechanically ventilated ICU patient will result in a decreased duration of mechanical     ventilation when compared to solely utilizing clinical sedation scales such as RASS.   "
94750|NCT02045914|"     The aim of this study is to evaluate calcium ionophore solution on fertilization rate of     patients during intracytoplasmic sperm injection who have poor ovarian reserve   "
94751|NCT02045901|"     The primary objective of this study is to compare the efficacy of Diclegis for the treatment     of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with     placebo.      The secondary objective of this study is to compare the safety of Diclegis in pregnant     adolescents aged 12 to 17 years with placebo by assessing differences in the severity and     occurrence of maternal adverse events (AEs).   "
94752|NCT02045888|"     To evaluate the safety and feasibility of adipose-derived regenerative cells injected into     tears of the hamstring muscle.   "
94753|NCT02045875|"     40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20,     will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3     months. These intervention subjects will receive medication use feedback at each visit, while     the control group will receive the standard of asthma care. Those interventional subjects     with Dulera adherence<60% will receive feedback based on an asthma adherence disease     management model protocol, Asthma Adherence Pathway. Intervention clinicians will been     trained in Motivational Interviewing to reduce subject ambivalence about medication use. The     primary hypothesis is that subjects who receive medication monitoring and Motivational     Interviewing adherence strategies will have better asthma control, as measured by the Asthma     Control Questionnaire, than the control group.   "
94754|NCT02045862|"     The purpose of this study is to examine how well the combination of two medicines     (solifenacin succinate and mirabegron) work compared to each medicine alone in the treatment     of bladder problems, and how safe they are for long term use.   "
94755|NCT02045849|"     This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study     will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation     compared to the reference capsule formulation under fasted conditions. The effect of food on     the pharmacokinetics (PK) of a single dose of the tablet formulation will also be assessed.     Part 2 will evaluate the effect of repeat doses of itraconazole on the pharmacokinetics of     GSK2140944 following a single dose. A decision will be made whether to use the current     capsule formulation or the new tablet formulation in Part 2 based upon the safety and PK data     obtained from Part 1. Part 3 is conditionally based upon progression of the tablet     formulation from Part 1 and will evaluate the effect of food on the safety, tolerability, and     pharmacokinetics of the tablet formulation following multiple doses in elderly healthy     subjects.   "
94756|NCT02045836|"     The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the     GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax     23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™     vaccine immune response will also be evaluated.   "
94761|NCT02045771|"     The study's primary goal is to assess the effectiveness of behavioural activation in reducing     depressive symptoms and re-integrate patients with depression into their personal and     professional lives thus improving quality of life and helping in attaining and maintaining     remission of depression. It is aimed at helping patients re-engage with several life areas     that they may have lost in the course of depressive illness. The intervention is centred on     behavioural activation (BA) with complementary interventions including recreation activities,     and behavioural modifications. The study question is: in patients with depressive disorder     attending a specialized hospital based mood disorders clinic, does the addition of     behavioural activation program delivered in a group format improve depressive symptoms and     quality of life compared to treatment as usual after 18 weeks of treatment? Study     investigators hypothesize that behavioural activation is an effective treatment for     depressive disorder in patients with depression.   "
94762|NCT02045758|"     This study will compare blood collection from the forearm using an investigational device     TAP20-C to blood collection from the fingertip.   "
94763|NCT02045745|"     The purpose of this study is to analyze the safety and feasibility of the implantation of     autologous mesenchymal stem cells (MSCs) expanded in vitro and administered directly in the     lung line of suture as a treatment for patients at risk of postoperative air leaks after lung     resection.   "
94764|NCT02045732|"     PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an     antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially     involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the     progression of the disease.   "
94765|NCT02045719|"     Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and     antitumor properties. Patients and methods: This prospective phase II study will assess the     effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals     with advanced solid tumors, with no further therapeutic options and with at least 2 months     life expectancy. In addition, several biochemical and inflammatory parameters will be     analyzed.   "
94766|NCT02045706|"     There are many trials measuring the impact of service work on volunteers themselves, but few     studies measuring the impact of service on the local people. The purpose of this trial is to     determine whether US and Ugandan health volunteers can make a measurable impact on the health     of rural Ugandan villagers.   "
94767|NCT02045693|"     The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed     dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in     subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with     the stable dose of Buprenorphine.   "
94768|NCT02045680|"     The use of laparoscopic surgery is continuing to increase in colorectal resection and     expected reach 80% in the next 10 years. Although laparoscopic (keyhole) or minimally     invasive surgery can lead to faster recovery it can also put significant stresses on the     patient's heart and cause fluctuations in blood pressure due to the extreme headdown     positioning and abdominal insufflation of carbon dioxide gas.      We have performed several surgical cases under deep neuromuscular block and this has allowed     surgery to operate at lower abdominal pressures (from 14 down to 8 mmHg). This put less     strain on the heart and allowed higher cardiac outputs.      This study will look at whether deep neuromuscular block is beneficial for patients by        1. Increasing oxygen delivery, measured using oesophageal doppler monitoring of          cardiovascular variables intraoperatively        2. Allowing surgery at lower abdominal insufflation pressures if they have a deep block        3. Reducing patient's analgesic requirements postoperatively in recovery and at 4 hours   "
94769|NCT02045667|"     The main objective of this study is to explore whether multiple trials with individual     patients (N-of-1 trials) can produce a reliable evidence base for coverage decisions on     clinical and cost-effectiveness of drug treatment for patients with rare diseases. As a case     study, we will study the clinical and cost-effectiveness of Mexiletine in patients with     Non-Dystrophic myotonia. The results of this analysis will be compared with the results     obtained from a recently published international, multi-centre, randomized,     placebo-controlled trial of Mexiletine in patients with Non-Dystrophic Myotonia     (clinicaltrials.gov Identifier: NCT00832000).      The secondary objective of this proposal is to assess whether mexiletine improves myotonia     measured (both quantitatively and qualitative) in patients with non-dystrophic myotonia.   "
94770|NCT02045654|"     To assess the efficacy of decitabine and identify predictors for response to decitabine     therapy.   "
94771|NCT02045641|"     One of the most common postoperative complications after open cardiac surgery is fluid     accumulation between the pleural membranes or in the pericardial sac. This study investigates     the consequence of such fluid accumulations on physical performance, recovery-time, cardiac     and respiratory complications, and quality of life. Half of the participants will be followed     closely and offered fluid drainage at a low threshold, and half of the participants will     follow the current postoperative regimen.   "
94772|NCT02045628|"     Although obesity surgery is currently the most effective method for achieving weight loss,     not all patients lose the desired amount of weight and some show weight regain. Previous     pilot work by the lead researcher shows that successful weight loss is associated with the     amount of investment the patient feels that they have made in their operation. For example,     those who feel that it has taken more time and effort to organise, has cost more money, has     been more disruptive to their family, social and work lives and has caused pain are more     likely to lose weight after their operation. Therefore, it seems as if the greater the sense     of investment, the greater the motivation to make the operation a success. The present study     aims to build on these findings by encouraging weight loss surgery patients to focus on the     investment they have made, thus making their investment more salient to them. Using a trial     design, half the patients will be asked to rate and describe the investment they have made in     their operation just before surgery (focusing on the time and effort to organise the surgery     etc) and 3 months after surgery (focusing on time off work for recovery, disruption of family     and friends, pain of surgery, pain of having the stitches removed etc). All patients will     record their weight, beliefs about food, intentions to change their behaviour and actual     eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. The impact of     the investment based intervention will then be assessed to explore whether focusing on the     investment involved in having surgery improves patient health outcomes by one year.   "
94776|NCT02045576|"     SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are     position dependent, defined as having an AHI, which is at least twice as high in supine     sleeping position compared to the AHI during sleep in other positions. Standard therapy for     patients having mild or moderate POSA is treatment with an Oral Appliance Trainer (OAT).     Recently a new device Sleep Position Trainer (SPT) is been introduced especially for patients     with POSA.      Objective: To compare the effect of positional therapy with the SPT versus OAT on     polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible     learning effect that might occur with POSA patients using the SPT for positional therapy over     a long term.      Study design: Randomised controlled trial Study population: The participants of the research     will be recruited from the departments of Otolaryngology and Clinical Neurophysiology, Saint     Lucas Andreas Hospital, Amsterdam, the Netherlands.      Participants will be males or females older than 18 years with diagnosis of positional OSA.      Intervention: The SPT is a sensor positioned in an elastic band attached around the body. The     SPT measures the body position and vibrates when the patient lies in supine position. Oral     appliance therapy (OAT) is an intra-oral prosthesis, which holds the mandible in a protrusive     position. Because of this position more pharyngeal space will be available and the AHI will     decrease. After randomisation the first group (n=45) will sleep for a period of 90 +/- 2 days     with the SPT every night. The second group (n=45) will also sleep for a period of 90 +/- 2     days only with OAT. After this period the PSG is repeated. Long- term outcome in AHI is     measured by repeating the PSG after 1 year. Main study parameters/ endpoints: Primary     endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of     sleeping supine sleep position, without disturbance of the sleep quality.      Secondary endpoints: Outcome of Quality of Life questionnaires; EQ-5D, ESS, FOSQ and MFIQ.      Compliance and learning effect will also be evaluated for the time period of 3 and 12 months.     Finally cardiovascular parameters like blood pressure, pulse rate and BMI/neck circumference     will be assessed.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The risks for patients participating in this study are negligible.     Inconveniences of the SPT can be discomfort caused by irritation of the band, difficulties     with an increased sleeping period on the side or difficulties sleeping with the SPT. This can     be compensated by the expected improvement of sleep quality caused by the therapy. Possible     side effects of OAT may be discomfort in the jaw, sensitivity of the teeth and a dry mouth.     Withdrawing from this therapy means immediate relief of inconveniences.   "
94777|NCT02045563|"     -  Our research hypothesis is to show that a certain number of genetic polymorphisms of the          proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the          development of steatosis in patients with Type 2 diabetes.        -  We also wish to evaluate more thoroughly lipid anomalies associated with the presence of          steatosis, notably with regard to monocyte expression of LDL receptors. We hypothesize          that hepatic steatosis is accompanied by activation of transcription factors involved in          lipogenesis, notably SREBP factors. The activation of these factors could cause an          increase in the expression of LDL receptors, leading to increased LDL catabolism.        -  Chronological description of the study During an outpatient consultation at the          endocrinology department, diabetic patients, programmed to undergo an examination to          assess their diabetes will be invited to participate in the study. Once written informed          consent has been provided and clinical data has been recorded, patients with type 1 or          type 2 diabetes will have standard biological examination, which is systematically done          in such patients (Fasting glycemia, HBA1c, aspartate aminotransferase, alanine amino          transferase, Gammaglutamyl-transferases, PAL, bilirubin, blood proteins, albuminemia,          Total Cholesterol total, HDL cholesterol, triglycerides, Sedimentation Rate, C-reactive          protein, fibrinogen).      As well as the systematic biological tests, 3 additional tubes will be taken to screen for     genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1,     Apolipoprotein A - II).      IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to     look for the presence of liver steatosis and to measure carotid intima-media thickness.   "
94778|NCT02045550|"     To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy     leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the     duration of the bronchitis episodes, on the severity and the additional drug demand. A     prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.   "
94779|NCT02045537|"     Study to determine the incidence of Bone Fractures in HIV infected patients in Spain   "
94780|NCT02045524|"     The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205 injection     at 10 mg dose administered by intramuscular injection using various injection techniques in     healthy male and female volunteers after a single dose administration.   "
94781|NCT02045511|"     The primary purpose of the study is to develop and test the preliminary efficacy of a     first-in-kind community-based intervention to provide affordable, accessible and effective     hearing health care to low-income, minority older adults.   "
94782|NCT02045498|"     Compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest     patients in both groups with and without capnography feedback   "
94783|NCT02045485|"     Background:      Several reports have demonstrated an association between psoriasis and cardiovascular     diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers     used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess     homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias.      Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient     psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG     and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis Area     and Severity Index (PASI).   "
94784|NCT02045472|"     The purpose of this study is to assess the safety, tolerability, immunogenicity and     pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.   "
94794|NCT02045342|"     This study will investigate the effects of hydrothermally modified starch (SuperStarch) in     adults. SuperStarch, originally developed as a drink for children with glycogen storage     disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended     periods. Therefore, it could be beneficial to exercise and mental performance, and could     possibly have fat loss effects by increasing feelings of fullness. In this study, measures     will be taken in 25 men to assess mental function, appetite, and metabolism to determine the     processes involved in possible fat loss.   "
94795|NCT02045329|"     The normal bacteria that inhabit the human nose, also known as the nasal microbiome, may     serve as a host defense mechanism against colonization and infection by Staphylococcus     aureus, including methicillin resistant S. aureus (MRSA). Mupirocin is a topical     antibacterial agent that may be used to clear nasal colonization with S. aureus, and reduce     risk of S. aureus infection. The impact of mupirocin on the normal nasal microbiome is not     known. We hypothesize that the nasal microbiome is changed by mupirocin. Our study aims to     define the nasal microbiome before and after decolonization therapy with mupirocin.   "
94785|NCT02045459|"     For part of this study, we are collecting information from patients that have been     experiencing the symptoms mentioned above. We are taking this information and creating a     chest pain registry to follow trends and compare different patients having similar symptoms.     We hope to gain insight into the quality of life, symptoms, and cardiac events of those who     are having similar symptoms. The type of information we will collect includes: demographics,     quality of life, levels of anxiety related to angina pain and cardiac events occurring within     a 2 year period of time.      In addition, we are performing a cardiac stress MRI for research purposes to look at the     blood flow in the small vessels in your heart. During the stress cardiac MRI, we will give     you a medication called Regadenoson (Lexiscan) which stresses your heart by dilating the     blood vessels to your heart. This drug is approved by the U.S. Food and Drug Administration     (FDA) for this purpose. We will then be able to measure the myocardial perfusion reserve     (MPR) which is a measure of blood flow through the small blood vessels to see if an abnormal     MPR and small blood vessel disease is associated with an increased risk of cardiovascular     events, such as heart attack. At this point, there is no specific therapy for small vessel     disease. In addition we have phase II of this study which is to determine if exercise and     intensive medical therapy together compared to intensive medical therapy alone improves pain     from the heart and improves overall quality of life.   "
94786|NCT02045446|"     The core hypothesis to be tested is that the use of consolidative SBRT followed by     maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary +     5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.   "
94787|NCT02045433|"     The purpose of this study is to determine whether SABR boost therapy is effective in women     with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI)     or genitourinary (GU) toxicity.   "
94788|NCT02045420|"     The purpose of this study is to use non-invasive Magnetic Resonance Imaging (MRI) scans to     investigate venous insufficiency, brain iron levels and white matter hyperintensities (WMHs)     to determine if there is direct correlation with Idiopathic Parkinson's Disease (IPD).      Idiopathic Parkinson's disease (IPD) is the second most common neurodegenerative disease     after Alzheimer's disease and it affects roughly 0.1% to 0.3% of the population. The risk of     having IPD increases with age and the median onset age is about 60 years. The etiology of IPD     remains unknown. Generally, Parkinson's patients show a reduction of dopamine levels in the     deep grey matter of the brain over time. Many clinically diagnosed cases of IPD are     associated with white matter hyperintensities (WMH) and elevated brain iron levels.     Furthermore, in the last few years there has been an increasing interest in the role of veins     in neurodegenerative diseases. More attention has been paid to the extracranial veins as     being potential sources of venous hypertension. The obstructed veins are thought to cause     venous insufficiency. By using MRI techniques, the investigators can not only obtain     qualitative vascular information but also quantitative arterial and venous blood flow     measurements.   "
94789|NCT02045407|"     The purpose of this study is to assess the reliability of computed tomography angiography     (CTA) to diagnose brain death, face of several conditions that make impossible to define such     diagnosis using clinical criteria exclusively.   "
94790|NCT02045394|"     Haemoptysis is the coughing up of blood originating from the respiratory tract. It is a     common and worrying clinical symptom which can be due to different aetiologies including lung     cancer, tuberculosis, COPD, bronchiectasis, pneumonia, acute bronchitis or unknown origin     (cryptogenic haemoptysis). Epidemiology and optimal diagnostic approach are largely unclear.     Aims of this study are to define current epidemiology and to provide the best diagnostic     approach by providing a diagnostic algorithm.   "
94791|NCT02045381|"     Currently, appropriate patients undergo MRI imaging with immobilization and sequences     optimized for diagnostic radiology purposes. Using a mutual information algorithm, these     images are then registered to a treatment planning CT obtained with custom immobilization to     minimize intra-and inter-treatment motion and positional variation. This image registration     process is time-consuming and introduces additional layers of geometric uncertainty into what     should be a highly precise treatment planning process. However, it is necessary, since     radiation dose calculations cannot be performed on MRI data due to the lack of crucial     density information. The investigator envisions CT-less treatment planning, using only MRI,     due to superior imaging characteristics, fully integrated into the radiation oncology clinic.     This study will begin this process.   "
94792|NCT02045368|"     This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in     patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV     infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Treatment continues until disease     progression, unacceptable toxicity, or patient refusal. Assessment of response will be     confirmed with imaging studies performed at the end of cycle 2 +/- 7 days, and every 2 weeks     thereafter.   "
94793|NCT02045355|"     Health effects of fish consumption have been demonstrated in epidemiological studies and in     controlled intervention studies in a number of different population groups, however,     randomized controlled studies on the effect of fish consumption in elderly are sparse. Many     studies have focused on n-3 fatty acids instead of fish as a food and therefore, many health     effects have only been related to the effect of n- 3 fatty acids. The elderly are a     heterogeneous population group and therefore difficult to study. In order to reduce     heterogeneity, it is advisable to focus on elderly with specific needs. Elderly who     experienced a hip fracture can serve as a model for an advanced ageing process, as these     patients typically experience a huge inflammatory response, immobilisation and a reduction in     muscle mass. Increased fish intake is believed to have effects towards inflammation and a     reduction in muscle mass. Therefore, we want to test whether increased fish intake can have     positive health effects in elderly who experienced a hip fracture.      Main hypothesis:      Increased fish intake (salmon, cod, pelagic fish), in comparison to meat, will increase     mobility, muscle strength and mobility in frail elderly.      Objectives        1. To evaluate the health effects of fish consumption in frail elderly The effect of a          dietary intervention with fish on mobility, muscle mass and strength in elderly who          experienced a hip fracture has not been shown before.        2. To demonstrate the feasibility of dietary intervention in elderly We want to show that a          dietary intervention with fish or control meals is feasible in elderly. The meals (4          portions of fish per week or control portions of meat) will be delivered to their homes.      Description of work and role of participants This is a randomized clinical trial (RCT) on the     effect of fish consumption on mobility in elderly who experienced a hip fracture. Elderly who     experienced a hip fracture but were able to walk without support by a person before the     fracture, will receive, after being randomized to two groups, fish or meat to be used in cold     or warm meals at 4 days per week for a period of 16 weeks. Measurements will be taken at     baseline (when patients have left the rehabilitation center), after 4 weeks and after 16     weeks. Measurements at 4 and 16 weeks after inclusion will be at their homes or in the     outpatient clinic.   "
95104|NCT02041273|"     A relative bioavailability study of commercial palbociclib free base hard capsules to the     isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different     fasting conditions.   "
94796|NCT02045316|"     The etiologic agent responsible for the development of preeclampsia remains unknown.     Aquaporins, members of integral membrane proteins, are responsible of water molecules     movements through the plasma membrane channels, energy metabolism and associated with changes     in cellular volume during apoptosis.      İn such placental pathology as preeclampsia, characterized with superficial implantation and     increased apoptosis leading to a relative hypoxia between mother and fetus, the hypothesis of     aquaporins important role in energy homeostasis and apoptosis maybe suggested.   "
94797|NCT02045303|"     Wound healing rate is higher when contact ultrasound therapy is followed by noncontact     ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies     requiring selective debridement, as compared to either Sonoca-180 or MIST Therapy alone.   "
94798|NCT02045290|"     Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a     sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1     Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will     improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic     euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to <20     year olds with BMI >85th percentile ( total daily insulin dose >0.7 units/kg, and HbA1c     7.0%-9.9%).   "
94799|NCT02045277|"     The objective of the study is to evaluate the safety and efficacy of a topical lotion   "
94800|NCT02045264|"     This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of     icatibant administered to adult Japanese subjects.   "
94801|NCT02045251|"     Over the years, it has become clear that the first-line triple therapy is losing efficacy     worldwide. A capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg     bismuth subcitrate potassium, and 125mg tetracycline was made available.      The efficacy of the Pylera capsule was studied in a randomized control trial, in which a     quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard triple     regimen. In the study, 3 three-in-one capsules were taken four times daily (after meals and     at bedtime).      Given the above, we aim at assessing the effectiveness of fewer pills per day of the Pylera     capsule (3 Pylera capsules supplemented with the addition of amoxicillin and esomeprazole     twice daily; sum of 10 pills/day for 10 days) in the eradication of H. pylori.   "
94802|NCT02045238|"     Acute viral bronchiolitis is an extremely common childhood disease, responsible for     approximately 17% of childhood admissions to hospital per year, with an annually cost that     reaches U$ 500 million.      Despite being a well known disease among pediatricians, there are few, if any, effective     treatment options apart from oxygen supplementation and adequate hydration.      The purpose of this study is to determine wether nebulized hypertonic saline (3%) is more     effective than normal saline (0,9%) when used in repeated doses during the first 24 hours of     in-hospital treatment.   "
94803|NCT02045225|"     Men who have sex with men (MSM) bear a disproportionate burden of the Human Immunodeficiency     Virus (HIV) epidemic in Canada, and HIV incidence appears to be rising among Canadian MSM     (1). MSM comprised nearly half (44.1%) of new positive HIV tests in 2009 (2). Among MSM in     Ontario, from 2001 to 2006, HIV diagnoses increased 26% (3). Given the alarmingly high HIV     prevalence rates among MSM in North American cities, there is a critical need for HIV     prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated     in interpersonal situations, is a reliable risk factor for unprotected anal intercourse (UAI)     among MSM (4 and 5). Social anxiety is highly modifiable via cognitive-behavioural therapy, a     form of psychotherapy (6). Social anxiety may also increase substance use in sexual     situations, which is another risk factor for HIV among MSM (7 and 8). As such, an     empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The     present study will provide Phase I trial data for a novel and innovative HIV prevention     intervention for MSM. This is a proposal to test a novel integrated HIV prevention     intervention that combines empirically supported treatments for social anxiety with HIV risk     reduction counseling to reduce HIV sexual risk behaviour.   "
94804|NCT02045212|"     The study objectives are to assess any changes in visual acuity and visual field observed     following the administration of RPh201 during an overall treatment period of at least 13     consecutive weeks with an option to extended the treatment phase to another 13 weeks (26     weeks total), and at the follow-up visit at 3 month after end of treatment in patients with     optic nerve neuropathy.   "
94805|NCT02045199|"     The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in     the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.   "
94806|NCT02045186|"     The purpose of this research study is to determine whether and when patients with human     papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and     chemotherapy clear their human papilloma virus infection.   "
94807|NCT02045173|"     The purpose of the study is to compare, three months after implantable     cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D),     the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with     similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable     impedance-based respiration sensor (AHIAS).   "
94808|NCT02045160|"     In this study, we aim to investigate the incidence of the adverse reactions, the     effectiveness and the gene polymorphism associated with the plasma level of     sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole,     sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate     the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.   "
94818|NCT02045030|"     This is a Phase II multi-center exploratory study to identify biomarkers predictive of     clinical response to aflibercept in patients with metastatic colorectal cancer who have     failed first-line therapy, consisting of an oxaliplatin-containing regimen in combination     with bevacizumab. Patients will consent to a needle core biopsy of a liver metastatic lesion     prior to starting treatment and blood samples will be collected from study patients during     treatment.      An exploratory pharmacoeconomic analysis will be performed to evaluate productivity loss,     quality of life and resource utilization while on treatment with aflibercept.   "
100052|NCT01976533|"     This is a historical cohort study with retrospective collection of data comprising all Nordic     patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is     to determine prognostic factors for mortality and morbidity.   "
94809|NCT02045147|"     There is overwhelming evidence that patients with multiple chronic illnesses need better     self-management skills. Discharge from the hospital may not be the most opportune time to be     teaching patients these self-management skills. There are several different care transition     models being used across the country; however we know that not every patient needs the same     type or amount of an intervention. The purpose of this pilot study is to examine the effects     of delivering a home based care transitions intervention (HBCTI) with four different groups     tailored on cognition and level of patient activation compared to usual care (UC) on the     outcomes of health care utilization (HCU) and health outcomes: patient-reported health     status, assessment of care for chronic conditions, and quality of life in adult patients with     multiple chronic diseases dismissed to home from an acute care facility. Our working     hypothesis is that patients in the HBCTI groups compared to the UC group will have lower HCU     and improved outcomes (patient-reported health status, assessment of care for chronic     conditions, and quality of life).   "
94810|NCT02045134|"     Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after a     cardiac surgery. Both systemic inflammation and oxidative stress play a role in the     initiation of POAF after a cardiac surgery. Epidemiological studies show a significant     inverse correlation between cardiovascular risk and consumption of polyphenol-rich foods     (PRFs), due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic     components. The main objective of this study is to evaluate the effect of polyphenol-rich     food supplementation on post-operative atrial fibrillation (POAF) in patients undergoing an     open heart surgery (mainly coronary artery bypass grafts (CABG) and valve replacement or     repaired (VR))   "
94811|NCT02045121|"     Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about     300,000 patients annually (UK and USA). Lung and breast cancers account for majority of     malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as > 90% of     patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling     and impairs quality of life. Median survival ranges between 4-6 months. Although     thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the     standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy,     and talc is the most effective agent. For successful pleurodesis to occur the underlying lung     must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%.     Symptomatic patients require hospitalization for these procedures which are likely to fail if     trapped lungs are encountered, and pose significant burden to health services. Tunneled     indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access     to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at     ambulatory setting without hospital admission. Case series have demonstrated long-term safety     of IPC even in patients undergoing chemotherapy with acceptable complication rates. By     keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of     patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc     pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to     determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in     hospitalizations, adverse events and healthcare costs, and if it improves quality of life.     The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc pleurodesis, and     endpoints include hospitalization days till death or end of study, adverse events, quality of     life, and healthcare costs.   "
94812|NCT02045108|"     The overarching goal of this study is to determine whether combined cognitive training and     Transcranial Direct Current Stimulation (tDCS) reduces drinking in high-risk drinkers. To     this end, specific study purposes are: 1) replicate previous findings that cognitive     retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced with     tDCS, and 3) investigate the neural changes that result from cognitive retraining and tDCS.     We hypothesize that those participants who receive alcohol avoidance cognitive training will     have greater reductions in drinking. In turn, those participants who receive a higher level     of applied tDCS during alcohol avoidance response training will have better avoidance     learning, as well as, a larger reduction in drinking behavior. Finally, those participants     receiving a higher level of applied tDCS will have more neuronal response associated with     alcohol avoidance during the brain imaging session.   "
94813|NCT02045095|"     This is an open-label, multicenter, phase 1, dose escalation study with expansion cohorts     that will evaluate the safety (establish the MTD and inform the RP2D), tolerability, PK,     pharmacodynamics, and antitumor activity of MLN7243 in patients with advanced malignant solid     tumors.   "
94814|NCT02045082|"     The purpose of this study is to compare a corneal sampling realized by a flocked swab     (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab     164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes     simplex epithelial keratitis will be the primary objective of this study.   "
94815|NCT02045069|"     This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and     Safety of Ivermectin in Children and Adult patients with Dengue Infection.   "
94816|NCT02045056|"     The purpose of this study is to assess the safety and efficacy of gemfibrozil in modulating     microRNA-107 levels for the prevention of Alzheimer's disease in subjects with intact     cognition and mild cognitive impairment   "
94817|NCT02045043|"     Arrhythmias remain a major health problem, causing at least 250,000 deaths annually in the     United States. Pharmacological treatments often do more harm than good, and device therapies     are limited by high cost and effects on quality of life. Ion channel mutations cause rare     inherited arrhythmopathies, but account for only a small fraction of patients with life-     threatening arrhythmias and sudden death. Most arrhythmias occur during myocardial ischemia,     following myocardial infarction, and in patients with poor left ventricular (LV) function of     any etiology. Aside from ejection fraction (EF), few clinically useful indicators to stratify     the risk of sudden death have been identified. The role of subtle difference in ion channel     expression and/or structure in predisposing patients to arrhythmias and modulating the risk     of sudden death is unknown.      In this study, we are prospectively testing whether polymorphisms in ion channels and ion     channel modifying genes are associated with arrhythmias in a population with internal     cardioverter-defibrillators (ICDs) and poor LV function. We will test the hypothesis that     functional polymorphisms in the coding sequences and promoter regions of cardiac genes (e.g.     ion channels, beta-adrenergic receptors) predispose individuals to arrhythmias and /or heart     failure progression.      We hope to identify genetic predictors for the common forms of sudden cardiac death. This     would allow the identification of a subpopulation of heart failure patients that would     benefit most from ICD placement.   "
95863|NCT02031367|"     The object of this study is to compare the effect of PRP versus Corticosteroid injection on     pain in patients with Greater Trochanteric Pain Syndrome up to 12 months after treatment. It     is believed that PRP will be as good as corticosteroids for short term pain relief, and will     produce longer lasting pain reduction.   "
94820|NCT02045004|"     Despite an ongoing controversy in the scientific literature, the link between anesthesia and     dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an     association of surgery with a reduction in brain volume. With the present prospective cohort     study, we would like to reproduce and verify these results, and investigate a possible     association with the postoperative cognitive performance.      We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months     after major non-cardiac surgery and determine cognitive functions at the same time.      Study hypothesis:        1. Surgery under general anesthesia in elderly patients is associated with a loss of gray          matter.        2. The degree of cognitive dysfunction is associated with the loss of grey matter in brain          areas relevant for cognitive functions.   "
94821|NCT02044991|"     The purpose of this study is to see if pelvic girdle pain can be more effectively treated     with the use of injectable anti-inflammatory medication plus physical therapy compared with     physical therapy and a saline injection.   "
94822|NCT02044978|"     16 patients will be included. Each patient receives 2 dental implants. One of them is coated     with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance     frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in     each patient are compared. We expect to find an early improvement (higher resonance     frequency) in the coated implant.   "
94823|NCT02044965|"     Although clean intermittent catheterization (CIC) remains the mainstay to ensure complete     low-pressure bladder emptying in neurogenic bladder (NB) patients, this forms a vehicle for     bacterial entry and colonization of the urinary tract, which can lead to recurrent urinary     tract infection (RUTI) and renal damage. Up to 25% of NB patients on CIC suffer from RUTI and     daily, low-dose antibiotic prophylaxis is widely prescribed to prevent these infections.     Unfortunately, this therapeutic option is not evidence-based and can be associated with a     higher risk of RUTI secondary to development of antibiotic resistance. In addition, many     children suffer from a range of adverse reactions and emergence of drug resistant organisms.     Moreover, recent studies have shown that antibiotics cause a major disruption in the human     microbiome, potentially leading to long term major problems.      Probiotics are live microorganisms, which when administered in adequate amounts confer a     health benefit on the host. There is evidence that probiotics restore microbial homeostasis     in the vagina, reduce the risk of pathogen ascension into the bladder, and modulate immunity     to better protect the host. Probiotic strains, including Lactobacillus rhamnosus GR-1,     Lactobacillus reuteri B-54 and RC-14, have been shown to be safe and efficacious in an oral     formulation or as a vaginal suppository in improving the microbiota profile of the vagina and     decreasing the risk of RUTI. Various mechanisms appear to be involved, including modulating     antimicrobial and inflammatory defenses, up-regulating protective mucin production and     reducing the pressure on pathogens to acquire antibiotic resistance genes. A randomized trial     comparing probiotics to antibiotic prophylaxis in children with vesicoureteric reflux showed     equivalent reduction in the incidence of RUTI and development of new renal scarring. In     addition, down regulation of inflammatory cytokines can potentially favorably alter bladder     function and prevent bladder fibrosis.      Investigators at London Health Sciences Centre (LHSC) have the opportunity to acquire     clinical data that would strengthen the case for probiotics to be integrated into pediatric     urology practice for managing CIC and RUTI. This would be the first such study in pediatric     NB patients.      The main objective of this study is to determine whether the use of probiotics (lactobacilli)     can decrease the impact of adverse side effects and the antibiotic resistance that is seen     with the prolonged use of antibiotics for patients with neurogenic bladder conditions.   "
94824|NCT02044952|"     The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in     the treatment of Crohn's disease for induction remission and compare the therapeutic effect     with patients who received mesalazine.   "
94825|NCT02044939|"     The primary objective of the study is to assess the improvement of daily activity in subjects     with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation     program.      The secondary objectives are the following:        -  assess the improvement of daily activity at several times : 2, 6 and 12 months after the          beginning of a pulmonary rehabilitation program        -  assess the improvement of exercise capacity by tests used in medical practice        -  assess the correlation between daily activity and exercise capacity        -  assess the improvement of dyspnea        -  assess the improvement of quality of life and psychological state   "
94826|NCT02044926|"     Purpose:      To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm     with malignant change according to international consensus guidelines 2012.      Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main     pancreatic duct size of larger than 10 mm will be significant.   "
94827|NCT02044913|"     The primary objective of this study is to test in a randomized controlled trial if     aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare     approach in the treatment of depression and anxiety.   "
94828|NCT02044900|"     The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes     for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes     evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation     index) and heart rate variability (HRV) indexes.   "
94829|NCT02044887|"     Objective: To assess the effectiveness of an intervention in Primary Health Care to increase     the physical activity (PA) and improve cognitive state and cardiovascular risk in patients     with dementia and their relative caregivers.      The results can be used to improve the technical characteristics of the devices that record     the physical activity of patients with dementia make marketing easier   "
94830|NCT02044874|"     In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo     will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12)   "
94831|NCT02044861|"     ACT-PFK-158 is a novel anti-cancer agent that inhibits glucose uptake in cancer cells. The     primary objective of the study will be to determine the maximum tolerated dose (MTD) and to     describe any dose limiting toxicity. The secondary objectives of the study will be to     determine the safety profile of the drug, to determine the pharmacokinetic profile, to     identify any anti-tumor activity, and to determine the pharmacodynamic profile of     ACT-PFK-158.   "
94832|NCT02044848|"     This study will assess the safety and efficacy of secukinumab on the preservation of     pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.   "
94865|NCT02044419|"     To compare the relative bioavailability of lomitapide when administered by sprinkling the     contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral     intact capsule dose of 20 mg lomitapide in healthy subjects.   "
94866|NCT02044406|"     To investigate the safety, tolerability, pharmacokinetics (including dose proportionality     assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising     dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus     the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI     1181181 (Bioavailability/Food effect (BA/FE) part)   "
94833|NCT02044835|"     • Background: Since evidence show that renal-artery stenting did not confer a significant     benefit with respect to the prevention of clinical events when added to comprehensive,     multifactorial medical therapy in people with atherosclerotic renal-artery stenosis[1], the     aim of our study was to confirm Fu-zheng-qu-zhuo (FZQZc) oral liquid, a herbal medicine,     combined with optimal medical therapy of internal medicine (OMT), including anti-platelet     therapy and other protocol-driven medical therapies to control blood pressure and glucose and     lipid levels in accordance with guidelines,resulted in greater renal function protection in     patients with atherosclerotic renal artery stenosis ( ARAS) compared with OMT alone.      Methods : A randomized, placebo-controlled, single centre clinical design. Sixty patients     with diagnosed atherosclerotic renal artery stenosis and had chronic kidney disease stage 3     will be recruited, and will be randomized into two groups in a 1:1 ratio ( FZQZ and placebo     Group, 30 respectively). FZQZ Oral liquid or placebo 20 ml every time, three times a day for     different groups, meanwhile, all participants in both treatment groups received OMT, 6 months     therapeutic period. Serum creatinine, estimated glomerular filtration rate(eGFR), urine     protein, and cardiovascular and renal events (a composite end point of death from     cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive     heart failure, progressive renal insufficiency, or the need for renal-replacement therapy)     will be compared between the Groups as the outcome.   "
94834|NCT02044822|"     The primary objective of this study is to evaluate overall response rate (ORR) following     treatment with idelalisib plus rituximab in participants with previously untreated chronic     lymphocytic leukemia (CLL) with 17p deletion.      An increased rate of deaths and serious adverse events (SAEs) among participants with     front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in     combination with standard therapies was observed by the independent data monitoring committee     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data     and terminated those studies in agreement with the DMC recommendation and in consultation     with the US Food and Drug Administration (FDA). All front-line studies of idelalisib,     including this study, were also terminated.   "
94835|NCT02044809|"     The purpose of this trial is to investigate a novel treatment for cannabis dependence:     cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for     moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims     to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use     over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can     offer an effective treatment for cannabis dependence.   "
94836|NCT02044796|"     This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride     when given together with filgrastim, cladribine, and cytarabine and to see how well they work     in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that     is newly diagnosed, has returned, or does not respond to treatment. Drugs used in     chemotherapy, such as filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride,     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading.   "
94837|NCT02044783|"     Sedentary older adults are more likely to develop physical function impairments than active     older adults. Physical function measured by slow usual gait speed predicts the risk of future     falls, disability, institutionalization and mortality. Behavioral physical activity     interventions have improved physical activity and physical function, but have not generally     been implemented where they may have the most impact -- primary care settings. In part, this     is due to the limited time and training for clinical staff to screen for physical function     impairment and to treat with physical activity counseling. The proposed scientific goal is to     overcome these barriers by adapting an evidence-based screening tool and telephone-based     physical activity intervention into primary care settings.      Aim1: Among older adults who screen positive for physical function impairment, to determine     the estimated intervention effect size of a 12-week behavioral intervention on physical     activity and physical function.      Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care     group.      Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.      Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and     Aim 1 intervention, to evaluate standard implementation science process metrics of reach,     acceptability, and implementation   "
94838|NCT02044770|"     The primary objective of this clinical study is to describe the initial clinical experience     with ENSEAL® G2 Articulating Tissue Sealer in laparoscopic colectomy, quantifying and/or     qualifying how its articulation feature enables optimization of vessel sealing through     improved access, approach, and visibility. This is an observational study of device usage     being conducted to report initial experience with the ENSEAL ART device. It is not intended     as hypothesis testing.   "
94839|NCT02044757|"     The purpose of this study to investigate the addictive properties of soda and other sugar     sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that     participants who were regularly consuming sweetened and caffeinated beverages will experience     symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB     withdrawal period.   "
94840|NCT02044744|"     The purpose of this study is to determine the impact of primary care referrals to community     physical activity programs for overweight and obese youth aged 6-18 years on objectively     measured physical activity and cardiorespiratory fitness, as well as other cardiovascular     health indicators. We hypothesize that physical activity referrals will result in higher     levels of physical activity and fitness.   "
94841|NCT02044731|"     The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session     childhood obesity intervention for African American families among children aged 5-12 years.     We hypothesize that children participating in the program will experience a reduction in BMI.   "
94867|NCT02044393|"     Investigation of the relative bioavailability of a single dose of BI 691751 when given alone     and together with itraconazole; safety and tolerability   "
94868|NCT02044380|"     The main aim of this study is to evaluate the safety and tolerability of afatinib in patients     with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal     Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR-Tyrosine     Kinase Inhibitor (TKI)   "
94842|NCT02044718|"     An adverse event (AE) is defined as unintended injury or complication, which results in     disability, death or prolongation of hospital stay, and is caused by healthcare management     (including omissions) rather than the patient's disease. Retrospective record reviews in     several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience one     or more AEs. A patient with an AE may require a higher level of care. Although all AEs are     important, preventable AEs that result in an upgraded level of patient care are of particular     concern. In this study it's defined as an unplanned admission to intensive care unit (ICU) or     a Mobile Emergency Team (MET) intervention. The objectives of this study are to determine the     incidence of (preventable) adverse events requiring ICU admission or MET intervention and to     assess the level of harm of each AE.   "
94843|NCT02044705|"     The purpose of this study is to evaluate the impact of the 10-week Active and Healthy     Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.   "
94844|NCT02044692|"     The objective of this study is to evaluate the long term safety and efficacy of once weekly     dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis     II) Patients   "
94845|NCT02044679|"     Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide     range of fluid intake behaviors   "
94846|NCT02044666|"     This study is intended to collect safety and effectiveness data on the Cook Micronized Small     Intestinal Submucosa (SIS)   "
94847|NCT02044653|"     The primary objective of study is        -  Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2        -  Part B : To evaluate the proof of concept (POC) of GX-E2   "
94848|NCT02044640|"     This is a retrospective chart review meant to identify any factors that are correlated with     and may possibly lead to postoperative nausea and vomiting in order to predict need for     longer hospital stays and potentially decrease postoperative nausea and vomiting.   "
94849|NCT02044627|"     This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002     and the routes and rates of excretion of [14C]-ETC-1002   "
94850|NCT02044614|"     1. To assess the feasibility and safety of applying a 12-week course of adjuvant          low-frequency icodextrin-based peritoneal dialysis to an ongoing regimen of          thrice-weekly in-center hemodialysis.           Hypothesis: Icodextrin-based peritoneal dialysis can be safely and feasibly implemented          in the context of ongoing thrice-weekly in-center hemodialysis.        2. To measure the effects of a 12-week course of adjuvant low-frequency icodextrin-based          peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis on:          inter-hemodialytic weight gain, achievable hemodialytic dry weight, total body water,          ambulatory blood pressure, serum phosphorus, and pre-to-post hemodialysis changes in          serum potassium and pH, and Kidney Disease Quality of Life-SF physical functioning,          energy fatigue, and general health scores.      Hypotheses: Addition of adjuvant icodextrin-based peritoneal dialysis will:        1. reduce inter-hemodialytic weight gain*        2. enable achievement of lower hemodialytic dry weight        3. reduce total body water        4. improve ambulatory blood pressure control        5. reduce serum phosphorus        6. minimize per-hemodialytic changes in serum potassium and pH        7. have favorable effects on indices of physical function and global health             -  Indicates co-primary outcomes.   "
94851|NCT02044601|"     The goal of the Phase I part of this clinical research study is to find the highest tolerable     dose of onartuzumab that can be given with erlotinib and standard chemoradiation (paclitaxel     and carboplatin) to patients with NSCLC.      The goal of Phase II is to learn if onartuzumab plus erlotinib and chemoradiation can help to     control NSCLC. The safety of this drug will also be studied.   "
94852|NCT02044588|"     To determine the safety of using kidney organ from hepatitis B surface antigen positive     donor, the author conducted the single-center, prospective study of the use of these kidneys     for recipients who have protective level of hepatitis B surface antibodies.   "
94853|NCT02044575|"     Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over     the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based     sepsis therapy bundles) the mortality of septic shock remains high and causes high     socioeconomical burden of disease.      The purpose of this pilot study is to evaluate the design and conduct of a projected full     scale clinical trial.   "
94854|NCT02044562|"     The purpose of this study is to evaluate whether dietary nitrate supplementation could     improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent     chemo-radiation therapy.   "
94855|NCT02044549|"     to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of     Postpartum hemorrhage after cesarean section   "
94856|NCT02044536|"     The optimal number of biopsy and the detection rate of neoplastic lesions are not     established. The aim of this study is to assess the current practice pattern and effect of     training in upper endoscopic biopsy.   "
94857|NCT02044523|"     Liver fibrosis is an important public health problem, with a substantial morbidity and     mortality due to progression to cirrhosis and hepatocellular carcinoma. All causes of chronic     liver disease may lead to fibrosis. The traditional diagnostic approach requires a biopsy for     assessing the severity of liver disease prior to therapy.      However, liver biopsy has several limitations: cost, sampling error, and procedure-related     morbidity and mortality. Considering the high prevalence of viral hepatitis and nonalcoholic     fatty liver disease, a condition often associated with obesity and type 2 diabetes, there is     an urgent need for noninvasive screening, diagnosis and monitoring strategies of chronic     liver disease severity.      Our team has the expertise to investigate ultrasound-based and magnetic resonance-based     elastographic methods for the noninvasive staging of liver fibrosis.      The primary objective of this cross-sectional study is to compare the sensitivity of     elastographic methods for detecting histology-determined significant fibrosis.      The secondary objectives are to compare the diagnostic accuracy of these elastographic     methods and the influence of potential confounders (inflammation, steatosis and iron     deposition) on their diagnostic accuracy.   "
94869|NCT02044367|"     To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of     dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran     etexilate as capsule following oral administration. To evaluate acceptability and     palatability of Pellets sprinkled on food and Oral Liquid Formulation   "
94858|NCT02044510|"     The proposed study is a randomized, double blind placebo controlled multicenter study to     determine the effectiveness of mirabegron in the treatment of neurogenic bladder dysfunction.     Patients will be randomized into one of two trial arms: mirabegron 25mg for two weeks, with     escalation to 50mg for the remaining 8 weeks, or matched placebo capsule for two weeks, with     placebo escalation for the remaining 8 weeks. Each of these trial arms will be stratified     based on whether the patient is already taking an anticholinergic medication or not. The     study will treat a total of 144 patients (72 with placebo, 72 with mirabegron). The study     hypothesis is that mirabegron will result in a statistically superior (increased) urodynamic     bladder capacity.      The study duration is 12 weeks, with a 1-4 week run in period where no active or placebo     treatment will be administered. The primary outcome measure will be based on an increase in     urodynamic bladder capacity. Secondary outcome measures will be additional urodynamic     parameters, urinary symptom scales, urinary quality of life indices, and voiding diary     results.      Patients who are over 18 years of age with a diagnosis of multiple sclerosis or spinal cord     injury will be eligible to participate. All eligible patients will have urodynamic studies     performed within 4 weeks of trial enrollment, and at the end of study (week 9-10). Adverse     events and study outcomes will be assessed at predefined study time points.   "
94859|NCT02044497|"     Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of     pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used     in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it     does in the body) and pharmacodynamics (how it works) have not been well established in     children. Some children, because of their specific genetic make-up, may metabolize the drug     more quickly and therefore may be at risk for more side effects in the commonly prescribed     dose. We would like to find out more about how this drug is absorbed, metabolized and     excreted in children. In order to study these aspects, we would like to give oxycodone to     surgical patients at Boston Children's Hospital then measure its metabolic activity and also     perform a genetic analysis. The genetic testing is specifically to analyze the following     genotypes only: cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4), which     represent the differences in cytochrome P450 metabolism of oxycodone.   "
94860|NCT02044484|"     This research, co-sponsored by the Centers for Disease Control and Prevention and the     National Institute of Mental health, is conducted at six HIV clinics in the U.S. The research     examines the effect of a clinic-based multi-component intervention delivered to HIV patients     when they attend clinic for primary care. The study tests the hypothesis that the     intervention will improve the viral load status of patients and improve attendance for HIV     primary care.   "
94861|NCT02044471|"     Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the     treatment of end-stage heart failure, affording patients significantly improved quantity and     quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide,     with nearly 1,000 at the Texas Heart Institute (THI). Despite the benefits from LVAD therapy,     one major weakness is the high frequency of late strokes, reported up to 19%. CF LVADs     minimize or remove the pulsatility within the blood system, introducing a new and     incompletely understood physiology.      Increased sympathetic (fight or flight nervous system) tone secondary to lack of pulse in     the blood system can cause high blood pressure, with subsequent hemorrhaging strokes     (bleeding into the brain) are one possible explanation for this high adverse event rate in CF     LVAD patients. A simple intervention to decrease the increased sympathetic tone is called     ischemic conditioning; a sphygmomanometer (blood pressure cuff) is placed on the patient's     arm to compress a major artery (ischemia) with subsequent release of the cuff (reperfusion)     for set periods of time. This has been shown to reduce blood pressure and major adverse     cardiovascular events in other patient populations.      We plan to conduct a trial to evaluate this intervention, ischemic conditioning, in patients     with CF LVADs. We hypothesize that IC will cause a reduction in blood pressure and strokes in     this patient population.   "
94862|NCT02044458|"     Study Design:      Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary     Purpose: Treatment      Detailed Description      The utilization of a Foley catheter for induction of labor is well established. There are two     techniques readily used for placing a Foley catheter. The most common method is under direct     visualization of the cervix during a sterile speculum examination and the other method is to     place a catheter during a digital cervical examination.      Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to     maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The     Foley catheter plus rigid stylette technique seems to be an efficient and safe method for     labor induction. However, to our knowledge there is no study that assesses the difference     between the standard digital placement of a Foley catheter versus the digital placement of a     Foley catheter with stylette.   "
94863|NCT02044445|"     During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is     administered to trigger the final follicular maturation before oocyte retrieval, in an     attempt to mimic the physiologic effects of LH. The hCG is administered when more than three     follicles ≥17mm in mean diameter have developed.      The time interval between hCG administration and oocyte retrieval is of critical importance     since the time after luteinizing stimulus is a period of intense processes including the     start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.      The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to     avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown     that significantly more high quality embryos have been obtained with a prolonged     hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be     beneficial in improving oocyte quality and achieving optimal maturation.      Currently there are no data on the effect of the time interval between hCG administration and     oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to     determine whether there is any difference in in vitro fertilization outcome when oocyte     retrieval takes place at 36 h or 38 h following hCG administration   "
94864|NCT02044432|"     The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at     least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at     least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to the     respective control group (waitlist).   "
94870|NCT02044354|"     Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as     second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has     demonstrated a survival benefit versus mitoxantrone in patients progressing during or after     Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have     different toxicity profiles.      Many patients who are receiving Jevtana for second-line treatment indicate they prefer this     agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail     changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was     associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than     Taxotere in first-line setting.      The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the     patient preference between two standard treatments for first-line metastatic kidney cancer.     Despite similar PFS improvements over placebo in phase III trials, results clearly showed     that patients preferred pazopanib over sunitinib.      A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in     first-line setting with overall survival as a primary end-point. Assessing patient preference     between Jevtana and Taxotere would contribute to further identify differences between these     two taxanes and clarify which one of these two taxanes should be used for second-line     chemotherapy and perhaps for first-line chemotherapy in the future.      Assessing patient preference between the two taxanes might be less biased in the first-line     setting where patients have no previous experience with a taxane.   "
94871|NCT02044341|"     Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear     infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The     patient or caregiver will measure the amount of ear pain before and after the ear drops to     establish if the medicated ear drops decrease the amount of pain more than the placebo ear     drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be     used up to 4 days, as needed for ear pain.   "
94872|NCT02044328|"     Adjuvant therapy has been proved effective in treating earlier stage or less advanced     non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as     adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The     primary endpoint is disease-free survival.   "
94873|NCT02044315|"     The aim of the present study is to investigate whether increasing detection zones can     effectively reduce inappropriate ICD therapies in primary prevention patients.   "
94874|NCT02044302|"     The investigators hypothesize that in mastectomy patients with breast reconstruction, the     addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the     acute and chronic setting, compared to traditional pain management techniques which rely     almost exclusively on opioid analgesics and sedatives like diazepam (valium). This     expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will     produce muscle relaxation, the combination of which will target different sites of pain     generation, thus producing better analgesia. We also hypothesize that additional benefits may     accrue from this regimen including decreased nausea and vomiting, sedation and constipation     as a result of diminished opioid use1.   "
94875|NCT02044289|"     The purpose of this study is to (a) measure how brain structure, metabolism (how the brain     uses energy), and function predict response to electroconvulsive therapy (ECT) for treatment     of depression; and (b) measure how ECT changes brain metabolism and function. We will ask you     to undergo magnetic resonance imaging (MRI) at three sessions: (1) prior to your first ECT     therapy session, (2) after having 4-6 ECT therapy sessions, and (3) approximately two months     following your first ECT therapy sessions.   "
94877|NCT02044263|"     Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior     Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a     negligible number of patients with insomnia receive this treatment. One potential way of     improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new     method for delivering CBT-I and it is not known how effective online treatment is compared to     face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I.     Because of the great advantage of online treatment in both availability and cost, the trial     is designed as a noninferiority trial.      Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with     CBT-I as delivered face-to-face by a therapist.   "
94878|NCT02044250|"     Objectives :      To compare the efficacy and safety of clopidogrel monotherapy with aspirin monotherapy in     patients who received dual or triple antiplatelet therapy for 1 year (± 6 months) after     drug-eluting stent implantation for coronary artery disease      Patient Enrollment :      5530 patients enrolled at 55 centers in Korea      Patient Follow-up :      Clinical follow-up will occur at 1, 12 and 24 months.      Primary Endpoint :      Composite endpoint of MACE and major bleeding      Secondary Endpoint :      Device-oriented composite outcome including TLR (target lesion revascularization), TVR     (target vessel revascularization), stent thrombosis, and minor GI (gastrointestinal)     complications   "
94879|NCT02044237|"     Online study for patients with trichotillomania. 4 main hypothesis.        1. Alexithymia and Trichotillomania correlated and regression analyses find association          between them        2. we will be able to find patient who have never been treated before. Those will suffer to          the same amount as previously treated patients        3. Decoupling will be more helpful than progressive muscle relaxation        4. different constructs of emotion regulation will show different trait and state          characteristics in patients with trichotillomania   "
94880|NCT02044224|"     The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE     procedures for solid tumours   "
94902|NCT02043925|"     Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a     QT-prolonging drug is added to a medication profile that already contains a potential     QT-prolonging drug. An ECG is taken before the administration of the new drug and a week     after starting the new drug to investigate the change in duration of the QTc-interval. Risk     factors for developing QT-prolongation and blood concentrations of potassium and creatinine     are documented.   "
95864|NCT02031354|"     The purpose of this study is to determine if administration of supplemental chloride in the     form of lysine chloride to patients with congestive heart failure will affect their     neurohormonal profile as well as response to diuretics.   "
94881|NCT02044211|"     Depression is highly prevalent among patients with heart failure (HF) and associated with     lower levels of health-related quality of life and physical functioning, and higher risk of     rehospitalization and mortality, and higher health costs. This Project will compare the     effectiveness of a blended telephone-delivered collaborative care intervention for treating     both HF and depression to: (1) collaborative care for HF-alone (enhanced usual care; eUC);     and (2) doctors' usual care for depression (UC). If proven effective and cost-effective,     the potentially more powerful, scalable, efficient blended care approach for treating HF     and co-morbid depression could have profound implications for improving chronic illness care     and stimulate development of blended interventions for treating other clusters of related     medical conditions.   "
94882|NCT02044198|"     The purpose of this study is to evaluate an experimental malaria vaccine for its ability to     prevent malaria infection or disease in a blood-stage challenge model (when volunteers are     infected with malaria parasites using malaria-infected red blood cells). The vaccine being     testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve     the body's response to a vaccination) called AS01B.      The aim is to use this protein and adjuvant to help the body make an immune response against     parts of the malaria parasite. This study will enable assessment of:        1. The ability of the vaccine to prevent malaria infection.        2. The safety of the vaccine in healthy participants.        3. The response of the human immune system to the vaccine.      This will be done by giving participants three vaccinations and then exposing them to malaria     infection by transfusing a small number of red blood cells infected with malaria under     carefully regulated conditions. Participants will be followed closely to observe if and when     they develop malaria. If the vaccine provides some protection against malaria, participants     will take longer to develop malaria than usual or will not develop malaria at all.      The study will enrol 15 participants to be vaccinated and then challenged with malaria in     addition to recruit 15 individuals to be control subjects.   "
94883|NCT02044185|"     Acute Graft-versus-host disease(aGVDH) after allogeneic hematopoietic stem cell     transplantation is one of the meaningful issues in aspect of patient's recovery and survival.     in recent years, the understanding of the pathology of GVHD is much important to prevent or     treat aGVHD. additionally, (oral) mucositis is one of the problems in patients with high dose     chemotherapy, and mucositis by high-dose chemotherapy is related to HMGB-1 as proinflamtory     cytokines. HMGB1 is a nuclear protein acts as a transcription factor, but, if it was released     to the outside of cells by damaged cell or necrotic tissues, it works as cytokines for     promoter of inflammation and cancers. at this point, there are no reported articles about     correlation of HMGB1 and aGVHD in human. recently, we have seen excessive secretion of serum     HMGB1 in mouse model, then base on this results, we will check correlation of HMGB1 and     aGVHD/ oral mucositis in human.   "
94884|NCT02044172|"     RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy     uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor     may not need treatment until it progresses. In this case, active surveillance may be     sufficient. It is not yet known which treatment regimen is more effective for localized     prostate cancer.      PURPOSE: This randomized phase III trial is studying active monitoring to see how well it     works compared with radical prostatectomy or radiation therapy in treating patients with     localized prostate cancer.   "
94885|NCT02044159|"     Approximately 20,000 children per year in North America present to the hospital with severe     shock. Children who develop this condition have very low blood pressures and as a result may     suffer damage to their internal organs and may even die. Some children with this condition     may significantly benefit from the use of steroids but steroids in such patients may also     have potential side effects. Therefore it is important to study the use of steroids carefully     in these children. The STRIPES research program will examine the effectiveness and safety of     steroids in children. Before conducting a large, randomized controlled trial (RCT), a pilot     study (STRIPES Pilot Study) will be conducted in multiple sites across Canada. The STRIPES     Pilot Study will allow testing of the STRIPES study protocol in a smaller group of patients.   "
94886|NCT02044146|"     In patients with heart attacks, the treatment of choice is to restore blood flow with     percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages).     After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications     block full function of the platelet cells, which are responsible for clotting. Despite their     use, patients after PCI are at risk for heart attacks, sudden clotting of stents or death. A     major contributor may be resistance to clopidogrel. New more potent drugs, which can overcome     the resistance, are now available; however, they come with an increase chance of severe     bleeding and costs. An ideal solution would be to identify at-risk patients and selectively     treat them with more potent drugs, while lower-risk patients continue with clopidogrel. This     type of strategy (personalized strategy) would decrease heart attacks and death (compared to     clopidogrel), while also preventing bleeding complications (compared to treating all patients     with the new drugs).      Of resistant patients, many carry genes (inherited units) that prevent proper absorption of     clopidogrel. Our group has developed and tested a new bedside genetic test, which identifies     carriers of at-risk genes. However, this technique alone does not identify all at-risk     patients. Consequently, we have now devised a novel tool, which combines genetics with     patient characteristics to identify high-risk patients.      The present study combines this new tool into a strategy for personalized treatment. Patients     with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies: a) new     personalized strategy, b) clopidogrel strategy (previous standard drug) or c) ticagrelor     strategy (stronger approved drug). The function of the platelet cells will be measured at 1     month to determine potential benefits. Evaluation of this new personalized strategy is     important for improving patient outcomes after PCI. The hypothesis is that patients receiving     a personalized strategy will have decrease risk for future heart attacks and bleeding.   "
94887|NCT02044133|"     The study will be proposed to man entering the prison of La Roche sur Yon. Participants will     be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6     months after the entry and the second arm will carry only a dosage six months after entry.      the purpose of the study is to determine the interest of dosage of vitamin D in biological     assessment of entry into prison house.   "
94888|NCT02044120|"     The purpose of this study is to define the dose-limiting toxicities and maximum tolerated     dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of     temozolomide in patients with pre-treated incurable Ewing sarcoma.   "
94903|NCT02043912|"     In this epidemiological point prevalence study, medication profiles of patients with     haloperidol treatment will be checked for drug interactions with risk of QT-prolongation.     Additional clinical risk factors for developing QT-prolongation and safety measurements will     be documented.   "
94904|NCT02043899|"     This study aims to show that 3-dimensional PET/CT imaging with a new novel PET tracer (called     [124I]mIBG) can detect as many or more sites of neuroblastoma (a type of childhood cancer)     compared to the recommended 1-dimensional routine scans (called [123I]mIBG planar     scintigraphy).   "
94889|NCT02044107|"     This project applies a randomized community design to test the effectiveness of health center     level co-packaging and counseling messages to improve provider and caregiver behavior in the     treatment of diarrhea with zinc & oral rehydration salts (ORS) and treatment of pneumonia     with zinc & antibiotics in children aged 2-59 mo old. We will evaluate the adherence of     caregivers in 10 health posts in 5 municipalities randomly assigned to receive the health     center level co-packaging and counseling messages in addition to current standard care, by     comparing them with the caregivers in 10 health posts in 5 municipalities randomly assigned     to the receive only the current standard of care. Cost-effectiveness of co-packaging at the     health-center level, as a means of improving provider treatment and counseling practices and     caregiver adherence, will be evaluated.      The main objective is to establish the effectiveness of a facility level co-packaging and     counseling messages for increasing the adherence by caregivers of children aged 2-59 mo old     to the prescribed 10 day treatment with zinc to complement ORS for the treatment of diarrhea     and zinc to complement the antibiotics for the treatment of pneumonia diagnosed and treated     in public health posts.      Specific Quantitative Objectives:      • To determine if visible co-packaging with pre-tested counseling messages:        -  Improves adherence of caregivers of children towards the prescribed zinc treatment.        -  Improves knowledge, awareness or attitudes of caregivers of children and health          providers at public health care centers towards the prescribed zinc treatment.        -  Results in overall increase in health care-seeking for the treatment of diarrhea and          pneumonia at public health care centers.      Specific Qualitative Objectives:        -  To establish the perception, attitudes and experiences of caregivers towards the visible          co-packaging with pre-tested counseling messages to promote the prescribed zinc          treatment.        -  To establish the perception, attitudes and experiences of health providers at public          health care centers towards the visible co-packaging with pre-tested counseling messages          to promote the prescribed zinc treatment.        -  To establish the perception, attitudes and experiences of children aged 4 to 5 years old          towards the visible co-packaging with pre-tested counseling messages to promote the          prescribed zinc treatment.   "
94890|NCT02044094|"     This is a multiple-dose study in non-treatment seeking male and female subjects with moderate     to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of     Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block     exogenous opioids.   "
94891|NCT02044081|"     The focus of the study is to evaluate the safety of multiple study drug administrations and     the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will     compare a liquid and gel product applied in different modes.   "
94892|NCT02044068|"     Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral     therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual     activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical     HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The     study hypothesis is a major reduction of the risk of HBV vertical transmission.   "
94893|NCT02044055|"     HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV     DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication.     Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about     vertical HDV transmission are old, justifying a new study.   "
94894|NCT02044042|"     Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to     10%). Spontaneous viral clearance in infected children during childhood can occur, but data     about this phenomenon are scarse, justifying the study.   "
94895|NCT02044029|"     This non-drug, single center, 24-week, longitudinal study in ambulant spinal muscular atrophy     (SMA) patients and in age- and gender-matched healthy volunteers will assess the detection of     disease progression by magnetic resonance imaging (MRI) and the Muscle Function Measure (MFM)     test.      Each participant will be evaluated in three testing sessions: at baseline, at Week 12 and at     Week 24. Both patients and volunteers will undergo MRI scans. Patients will additionally     undergo testing of motor function and have blood samples taken for Survival of the Motor     Neuron (SMN) genes, proteins and mRNA analysis.   "
94896|NCT02044016|"     The purpose of this study is 1) to develop and validate a new measurement to assess the     length of the Achilles tendon after rupture, and 2) to examine if goniometer measurement of     the ankle joint is a better method.   "
94897|NCT02044003|"     The study is intended to evaluate the safety and feasibility of using the Intact Vascular     (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System)     in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.   "
94898|NCT02043990|"     Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the     machine applies positive pressure throughout inspiration in proportion to the electrical     activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test     the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV     delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with     Acute Respiratory Failure.   "
94899|NCT02043977|"     Insomnia is a widespread condition in which approximately one-third of adults in the United     States are symptomatic with 6% of the population meeting the diagnostic criteria for     insomnia. There is an increased risk of insomnia in certain segments of the population     including women, middle-aged and older adults, shift workers and individuals with medical or     psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to     those who report other serious illnesses such as major depression and congestive heart     failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric     disorders, medical and neurologic disorders. It can impair cognitive and physical     functioning.      Propofol is an approved drug administered intravenously for use in the induction and     maintenance of anesthesia or sedation. Some research suggests that propofol when administered     as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening     and the integrity of behavior following waking.      This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct     care of a Board Certified Anesthesiologist, dedicated to the study involving participants who     have refractory chronic primary insomnia and have not responded to conventional pharmacologic     therapies within the past 90 days. Each qualifying participant will receive an IV infusion of     the study medication for 5 consecutive nights. Assessments including polysomnography with     completion of questionnaires will occur at screening, Days 1 through 5 of study product     administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day     180.   "
94900|NCT02043964|"     This is a multicentric and prospective study for the validation of a diagnostic method in     multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that     can be recognized in order to help in the diagnosis of this pathology and that could possibly     replace the lumbar punction which is an invasive method. Semi-automatic and automatic     techniques of isoelectric focusing will be developed for analyzing data from tears. These     results will help in the identification of markers of this disease.   "
94901|NCT02043951|"     The registry will enroll patients with claudication or critical limb ischemia and     angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be     treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to     the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.   "
94905|NCT02043886|"     Postprandial hypotension carries a risk of significant morbidity and morbidity including     syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy     consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of     which are suboptimal and poorly studied.      The study hypothesis is that administration of Acarbose will decrease the drop in blood     pressure and increase in heart rate in response to food in people with Type 2 diabetes.      Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and     delaying gastric emptying.      This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the     meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one     meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo.     Order of treatment assignment will be done in randomized fashion. A total of approximately     200 cc of blood will be drawn during each meal test.   "
94906|NCT02043873|"     Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess     the longevity of repairs to localized clinical defects in composite restorations that were     initially scheduled to be treated with a restoration replacement Methods: 28 patients aged 18     to 80 years with 50 composite restorations were recruited.Restorations with clinically     diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were     randomly assigned to the Repair (n = 25) or Replacement (n = 25) group, the quality of the     restorations was scored according to the modified USPHS criteria. A Wilcoxon test was     performed for comparisons between the same groups (CI=0.05). A Friedman test was utilized for     multiple comparisons between different years of the same group.   "
94907|NCT02043860|"     In this phase I trial, patients with multiple myeloma will receive standard high dose     melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will     include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will     increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients     enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.   "
94908|NCT02043847|"     In this phase I trial, patients with relapsed or refractory multiple myeloma will receive     standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant     conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3     phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is     reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose     will be 9Gy.   "
94909|NCT02043834|"     The aim of the present study is to evaluate an innovative virtual reality-based balance     training intervention for improving clinically relevant motor performances (balance and gait)     in older adults.      We hypothesize that the virtual reality-based balance training intervention will improve     balance and gait performances in older adults compared to a control group receiving usual     care only.   "
94910|NCT02043821|"     Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy     are candidates for an convenient maintenance treatment.   "
94911|NCT02043808|"     The objective is to assess the safety and effectiveness of new dabigatran and warfarin     patients diagnosed with NVAF in the US DoD population.   "
94912|NCT02043795|"     The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable     Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects     with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of     the tibial arteries.   "
94913|NCT02043782|"     The aim of the investigation was to investigate the performance and safety of a new ostomy     product   "
94914|NCT02043769|"     The Pediatric Enhanced Surveillance Study is a three part study of HIV-infected infants and     children in South Africa to examine, clinical, immunologic, virologic, metabolic,     psychosocial and behavioral outcomes. This study has two parts: (1) comprehensive     de-identiﬁed records review of all HIV-infected children enrolled in at the pediatric     Wellness and ART clinics at the ﬁve study sites; and (2) a prospective cohort surveillance     study with active consented enrollment with 12-24 months of follow-up. As part of the     prospective cohort, the study will aim to collect outcomes on children lost to follow-up,     including causes of death through review of death certiﬁcates in the clinical chart and     through verbal autopsy reports. The study will provide insights into overall outcomes for the     larger pediatric patient populations in the province and South Africa. This work is designed     in collaboration with the provincial health authorities of the Eastern Cape Department of     Health (EC), The International Center for acquired immune deficiency syndrome (AIDS) Care and     Treatment Programs (ICAP) South Africa and Center of Disease Control (CDC)-South Africa in     support of the South African National ART Program for Children and aims to collect and     analyze accurate, relevant and useful information that will be available on children seen at     facilities. For the prospective cohort study, we will aim to enroll 400 children newly     initiated on ART at 5 health facilities in the Eastern Cape of South Africa who will be     actively followed for up to 24 months.   "
94915|NCT02043756|"     The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD),     and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.   "
94916|NCT02043743|"     Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary     ovarian insufficiency (this is the most accurate term as some women may still conceive),     premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to     function adequately in a woman younger than 40 years, in its role either as an endocrine     organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism,     and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer     responding to circulating FSH by producing estrogen and developing fertile eggs) in women     younger than 40 years. This condition occurs in approximately 1% of women and it has     important physical and psychological consequences/impact in those patients.      The purpose of this study is to investigate the role of the transplantation of bone marrow     derived stem cells into ovarian tissue for treatment of premature ovarian failure and to     assess their ability to differentiate into germ cells.   "
95105|NCT02041260|"     Phase II, non-randomized, open-label study to determine the efficacy of cabozantinib as a     firstline treatment for patients with differentiated thyroid cancer (DTC). Subjects will     receive drug at a starting dose of 60mg PO QD. Subjects can receive drug as long as they     continue to derive clinical benefit or until they experience unacceptable drug-related     toxicity.   "
94917|NCT02043730|"     Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment     approaches to locally advanced pancreatic cancer management.      Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic     cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a     progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting     activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and     gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.   "
94918|NCT02043717|"     The investigators study is designed to test the hypothesis that correction of vitamin D in CF     patients can increase their lung function and decrease the number of their pulmonary     exacerbations.   "
94919|NCT02043704|"     This randomized controlled trial will evaluate the effects of perioperative intravenous (IV)     acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing     vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive     either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive     1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control     group will receive placebo saline infusions at the same time intervals. All subjects will     receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS)     regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to     discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects     receiving IV acetaminophen will have lower VAS scores and decreased total narcotic     consumption in comparison to the control group.   "
94920|NCT02043691|"     This is a single-center study to evaluate the safety and effectiveness of three     investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular     Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving     the visceral vessels.      The three investigational devices offer an endovascular approach to treat complex aortic     pathologies that cannot be treated with commercially available devices. This customized,     endovascular approach has the potential to decrease hospital length of stay, pulmonary     complications, and in-hospital mortality.   "
94921|NCT02043678|"     To determine if the addition of radium-223 dichloride to standard treatment is able to     prolong life and to delay events specific for prostate cancer which has spread to the bone,     such as painful fractures or bone pain which needs to be treated with an X-ray machine.   "
94922|NCT02043665|"     The purpose of this trial is to assess the ability of CVA21, either alone (Part A) or in     combination with pembrolizumab (Part B), to reach and to replicate in existing tumors (while     sparing normal cells) and to establish a safe multi-dose schedule of the virus for the     treatment of solid tumors where enhanced expression of ICAM-1 and/ or DAF receptor occurs.      This trial consists of 2 sequential parts: VLA-009 (Part A) conducted only in the UK and     employed CVA21 as a monotherapy in NSCLC, castrate-resistant prostate cancer, melanoma and     bladder cancer. VLA-009 (Part B) conducted in the US, AUS and UK employs CVA21 with     pembrolizumab in NSCLC and bladder cancer.      Both VLA-009A and VLA-009B are open-label, multi-center, ascending dose escalation (3+3     design) dose-finding and signal-seeking studies.      Part A of the study is now complete and closed to enrolment. Part B is currently enrolling.   "
94923|NCT02043652|"     Background: The World Health Organization recommends that antimalarial treatment policies be     evaluated every few years to check their efficacy. P. vivax malaria is the most common     species in Brazil and cases are concentrated in the Amazon Region in Brazil.      Objectives: Assess the efficacy of chloroquine and primaquine for the treatment of P. vivax     infections in Cruzeiro do Sul, Acre, Brazil.      Methods: An in vivo drug efficacy study will be conducted in Cruzeiro do Sul, Acre State,     Brazil. A total of 117 study participants ≥5 years of age with parasitologically confirmed P.     vivax monoinfections will be treated under supervision with chloroquine (CQ) for three days     at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National Malaria     Control guidelines. For patients with normal glucose 6 phosphate dehydrogenase activity     levels, investigators will add primaquine at dose of 0.5mg/Kg per day for 7 days. Clinical     and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate     drug efficacy and for a total period of 168 days (6 months) to evaluate chances of     recrudescence, relapse, or reinfection. Blood samples will be taken to measure the CQ levels     in blood on Day 7 and day of failure, if occurring in the initial 28 days of follow up. In     addition, a blood sample will be collected on filter paper on first day and on day of     suspected failure to help differentiate parasite genotypes using techniques based on     polymerase chain reaction. Results from this drug efficacy study will be used to assist the     Brazilian Ministry of Health in assessing their national malaria treatment policy for P.     vivax malaria.   "
94924|NCT02043639|"     In this study, the goal is to find out if the clinicCompanion™ is effective in measuring     range of motion when compared to the goniometer. Currently, the goniometer is an approved     device to measure range of motion by the FDA, but the clinicCompanion™ is not.   "
94925|NCT02043626|"     Our long-term objective is to reduce the rates and risk of childhood obesity via school-based     nutrition and physical activity policies. Using a randomized design, we propose to monitor     and evaluate how Connecticut's first-ranked District Wellness Policy, in the New Haven Public     School district, is implemented and determine its impact on children's obesogenic behaviors,     weight outcomes, and school performance. This study is designed to significantly advance     empirical research on school wellness policies and to provide important evidence to guide     future interventions in schools and communities - translating science to improved health of     the public.   "
94926|NCT02043613|"     The study is designed to investigate the effect of physical surroundings on the effect of     exercise therapy for knee and hip pain.   "
94927|NCT02043600|"     The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention     compared to self-care on quality of life, stress, psychological health, and physiological     parameters in 77 patients with ulcerative colitis.   "
94928|NCT02043587|"     The objective of this protocol is to improve survival for adults with acute lymphoblastic     leukemia or acute lymphoblastic lymphoma by reducing systemic and central nervous system     (CNS) relapse with acceptable toxicity using intensive chemotherapy with liposomal cytarabine     (Depocyt®) CNS prophylaxis.   "
95106|NCT02041247|"     The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV     patients receiving standard of care antiretroviral treatment.   "
94929|NCT02043574|"     Strokes are very common in the United States and occur more in the elderly. The number of     strokes is likely to double in the next 50 years. Many stroke survivors are sedentary and     have a poor dietary intake, which results in abnormalities in fuel utilization (eg     carbohydrate versus fat). This study will examine the effects of dietary modification and     treadmill training on fuel utilization and physical function. We will study skeletal muscle     oxidative stress in chronic stroke patients and the ability to employ dietary modification     and exercise training to reverse these abnormalities in this ethnically diverse population.   "
94930|NCT02043561|"     The aim of this study will be to investigate the effect of rectal distension, controlled by     electronic barostat, on cognitive control ability in healthy subjects. We will use the Stroop     task and an intertemporal choice task as standard instruments. Like bladder control and     rectal control, both Stroop task performance and intertemporal choices - though very     different tasks at the surface - are dependent on the conflict monitoring function of the     anterior cingulate cortex. The Stroop task requires the naming of the print color of a series     of visually presented color words, and reaction time and error rates are typically used as     performance indicators. When word color and word meaning do not match, performance of the     task (color naming) requires the inhibition of a (near) automatic response (word reading).     The intertemporal choice task consists of a series of choices between a sooner smaller     monetary reward and a larger but later reward. The choices are constructed such that they     allow the estimation of a discount parameter, which is an index for the level of     impulsiveness manifested by the participant at the time the choices are made.      The hypothesis is that the inhibition induced by the urge generated during rectal distension     will improve cognitive inhibitory performance, as has previously been shown for bladder     filling.   "
94931|NCT02043548|"     The purpose of this multi-center pilot study is to determine if the drug tocilizumab     (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM)     and dermatomyositis (DM).   "
94932|NCT02043535|"     Myocardial perfusion imaging (MPI) is a nuclear scan using a radioisotope to see blood flow     to the muscles of the heart when the heart is at rest and when it is under stress. The stress     test in MPI can be done using medications, such as adenosine, that dilate coronary arteries     and increase blood flow. Similarly, elevated carbon dioxide (CO2) levels in the blood, or     hypercapnia, also dilates arteries and increases blood flow. Thornhill Research Inc. has     developed the RespirAct ™ Gen4 sequential gas delivery system used to control CO2 levels in     the blood. The RespirAct ™ Gen4 can deliver precise amounts of CO2 through a mouthpiece for     inhalation to increase CO2 levels in the blood and thereby increasing blood flow like during     stress.      The objective of this study is to compare the differences in blood flow through the arteries     of the heart during stress with hypercapnia and adenosine MPI. The imaging will be done using     positron emission tomography (PET) with the radioisotope, or tracer, called Rubidium (Rb-82).     The Rb-82 is given through a pump, or elution system.      The investigators hypothesize that hypercapnia will induce a stress-to-rest increase in     myocardial blood flow by a factor of 2 or more in myocardial regions supplied by non-stenotic     arteries in normal volunteers and participants with coronary artery disease.   "
94933|NCT02043522|"     This study is being done with a radioisotope, 123I-mIBG (Adreview), to develop a nuclear     diagnostic imaging test for patients with decreased heart function which can be used to     predict the progression of the heart disease and provide the appropriate clinical treatment.     The types of patients to be studied include patients who have had a heart attack where heart     muscle may be damaged and patients diagnosed with heart failure who have enlarged hearts.     Both conditions may cause poor muscle contraction and disturbances in electrical signal     conduction. There will also be a control group of participants with no evidence of heart     disease.      123I-mIBG has been shown to be effective in assessing the areas of the heart being activated     involuntarily by the sympathetic nervous system (SNS). 123I-mIBG is an iodine based     radioisotope that is chemically similar to norepinephrine (NE) in the heart. NE is     responsible for the way the SNS regulates heart functions such as heart rate and the force of     heart contractions. NE acts automatically to maintain a homeostasis or balance within the     SNS. The amount of 123I-mIBG, mimicking NE, that appears on the nuclear image using the     heart-to-mediastinum ratio (H/M ratio), was predictive of the progression of heart failure,     arrhythmias (irregular heartbeats) and cardiac death.      Two different types of single photon emission computed tomography (SPECT) imaging will be     used: standard SPECT and cadmium-zinc-telluride (CZT) SPECT. The investigators hypothesize     that CZT SPECT will have greater H/M ratios than standard SPECT imaging.   "
94934|NCT02043509|"     The overall aim of the study is to estimate the likely impact of the MiQuit text message     based smoking cessation service for pregnant smokers and to establish robust estimates for     the key factors which would be required in order to design a larger definitive trial of this     intervention(MiQuit).      These key factors include: the range of recruitment rates in different centres; quit rates     amongst participants; feasibility of assessing smoking status of participants in later     pregnancy; and the likely effect of MiQuit when women are offered this in National Health     Service (NHS) settings.   "
94935|NCT02043496|"     The purpose of the study is to test a newly developed individual psychotherapy treatment for     binge eating disorder in adults. This treatment is a type of individual psychotherapy called     Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their     behaviors, feelings, thoughts about themselves, and relationships. This new treatment is     being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help     (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework     assignments along with sessions with a therapist. The primary hypothesis of this     investigation is that ICAT will be associated with greater reductions in binge eating at end     of treatment and follow-up compared to CBTgsh.   "
94936|NCT02043483|"     Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely     metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no     molecular markers for this physiopathological connection have been identified.      This project aims to determine non-invasive biomarkers that may allow better comprehension of     the metabolic consequences of OSAS, as well as assess the effect of Continuous positive     airway pressure (CPAP) on these metabolic parameters.      This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems     to further explore the mechanisms behind OSAS, as well as the effect of the treatment with     CPAP.   "
94938|NCT02043457|"     The Investigational Weight Management Clinic at the University of Michigan was created to     identify strategies that will result in cost-effective, long term weight management for     overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size     fits all' philosophy is untenable with a complex disease such as obesity. The clinic will     serve as a portal for patients to choose standard clinical care or to explore alternatives     from a variety of clinical studies offered through the clinic. These studies will include     further investigations into nutrition, the biological basis of weight and weight management     and protocols using approved and experimental pharmaceuticals.   "
94939|NCT02043444|"     Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm     cells by positive testicular extraction and those with a negative extraction.   "
94940|NCT02043431|"     The purpose of this study is to develop a biobank containing samples of 2,000 patients     treated in a tertiary cardiology hospital containing electronic medical records and genetic     data in genome-wide scale for performing genetic association studies for validation and     development of medical decision routines that help the clinical management of heart failure     patients.   "
94941|NCT02043418|"     This study aims to assess the long-term outcomes of children infected with HIV, having     participated in the ANRS 12140 PediacamI study, in terms of: clinical and immunovirological     response to ARV therapy, long-term ARV tolerance, and the impact of family environment and     lifestyle on adherence to ARV treatment.   "
94942|NCT02043405|"     The investigators will use exercise training and weight loss to discover localized lipid     species related to diabetes risk in people.   "
94943|NCT02043392|"     Anastomosis of intestine or other viscera currently requires open or laparoscopic surgery and     is often the most difficult, time-consuming, and expensive part of many operations. We have     developed a device (Magnamosis) that may create compression anastomoses more easily,     quickly, and less expensively than sutures or staples. The Magnamosis device consists of two     23-mm diameter, convex-concave, radially symmetric ring magnets encased in polycarbonate. One     magnet is placed in the lumen of each viscus to be joined, the magnets self-align, and a     compression anastomosis is achieved by tissue remodeling. We have completed extensive     pre-clinical studies in animals and have shown that Magnamosis can be used to accomplish     gastrojejunostomy, jejunojejunostomy, duodenal-colostomy, and colo-colostomy safely and     effectively using available endoscopic and minimally invasive surgery techniques. We are now     conducting a small first-in-human study to obtain clinical data in support of the safety and     early feasibility of the Magnamosis device.   "
94944|NCT02043379|"     The purpose of this study protocol is to determine if administering Intravenous     Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced     hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes     (i.e., infection, fluid overload, and associated morbidities).   "
94945|NCT02043366|"     Purpose:      To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a     combination of both received before anesthesia induction.      To evaluate and examine the incidence of adverse effects with the purpose of selecting the     optimum dose.   "
94946|NCT02043353|"     Sleep-disordered breathing in children is characterized by recurrent events of partial or     complete upper airway obstruction during sleep, resulting in disruption of normal gas     exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom is     snoring or noisy breathing. Sleep Disordered Breathing (SDB) is a wide spectrum of disorders     that includes primary snoring, UARS and OSA. The main etiology for SDB in children is     enlarged tonsils and adenoids and therefore the first line of treatment in pediatric SDB is     adenotonsillectomy.      The objectives of this study are:        1. To investigate the natural history of primary snoring        2. To investigate the effect of seasonality on SDB severity        3. To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in          children        4. To characterize the children referred for repeated PSG following adenoidectomy or          adenotonsillectomy and the indications for second PSG evaluation.   "
94947|NCT02043340|"     In recent years, there has been a growing interest in the use of dental lasers for treatment     of periodontal diseases. Commercially available photodynamic therapy for periodontal diseases     utilizes methylene blue as a photosensitizer. In this study, the effects of a novel     photosensitizer dye, indocyanine green (ICG), as an adjunct to nonsurgical treatment of     chronic periodontitis will be evaluated.   "
94948|NCT02043327|"     The aim of this study is to create simulation-based tests with credible pass/fail-standards     for two different fidelities of colonoscopy models        1. virtual reality simulator        2. physical model simulator To create pass/ fail standards for certification   "
94949|NCT02043314|"     The recommended treatment for latent tuberculosis infection for adults is a daily dose of     isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The     treatment duration and the high pill burden compromised patient adherence to the treatment.     The Brazilian National Programme for Tuberculosis requested the development of a new 300mg     isoniazid formulation. The aim of the study is to compare the bioavailability of the     isoniazid 300mg new formulation and three 100mg tablets of the reference formulation.      The study is a randomized, single dose, open label, fasting, two-phase crossover     bioequivalence study with a wash out period of 7 days (>7 half-life) in 28 healthy human     volunteers. For the determination of isoniazid in human plasma, the investigators developed     and validated a sensitive, simple and rapid HPLC-MS/MS method.      This will support the strategy adopted by the Brazilian National Program for Tuberculosis for     the treatment of latent tuberculosis. The new formulation will increase patients' adherence     to the treatment and quality of life. Medical doctors in Brazil should become aware of the     new formulation and the new treatment strategy in order to prescribe the right medication and     avoid errors that could result in a high frequency of adverse events. Future research studies     should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact     on the cure rate.   "
94950|NCT02043301|"     This study aims to characterize the single dose pharmacokinetics of PF-04950616 following     subcutaneous injection to the abdomen, upper arm or the thigh.   "
94951|NCT02043288|"     This clinical trial is designed to evaluate the impact of the addition of NC-6004 to     gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic     cancer in Asian countires.   "
94954|NCT02043249|"     In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in     the age of 3-5 month after birth the infant start to develop them by himself.      In preterm infants the starting point of the level of the IgG's is lower from the level of     term infants.      Delayed cord clamping /milking it was prooved in many researches as benificial in terms of :     levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by     means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing entero     colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking it will     increse the level of IgG's in preterm infants. The end point hypothesis is that delayed cord     clamping /milking cause to less fever disease or hospitalization it the neonats.   "
94955|NCT02043236|"     This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health     in men receiving androgen deprivation therapy (ADT).   "
94956|NCT02043223|"     The purpose of this study is to evaluate the effect of post-partum maternal vitamin A     supplementation on breast milk bioactive compounds and immune status, growth and morbidity of     children in the first four months of life.   "
94957|NCT02043210|"     The investigators are conducting a randomized clinical trial of our new web-based version of     the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) in Spanish. This     program specifically designed for Spanish-speaking substance users to evaluate its     effectiveness relative to standard outpatient counseling at the Hispanic Clinic. The     computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting     examples of effective use of coping skills in a number of realistic situations in video form,     and providing opportunities for patients to practice and review new skills while receiving     substance use treatment.   "
94958|NCT02043197|"     Prospective, multicenter, non-comparative, observational program to describe prevalence of     depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the     severity of anxiety and depression, sleep state, and cognitive function.   "
94959|NCT02043184|"     Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals of     this study are to improve adherence to oral chemotherapeutic medications and self-management     of symptoms among cancer patients. More than 40 oral agents currently are on the market with     projections that in three years 30% of the cancer treatment agents will be delivered in oral     form. As a result, patients must assume responsibility for taking medications and     self-management of associated side effects.      This longitudinal randomized trial tests and compares 'two strategies' for improving patient     adherence to their oral cancer medication prescriptions to standard care. Both strategies     incorporate symptom management support using an interactive voice response system (IVR) for     symptom assessment and a printed evidence-based Medication Management and Symptom Management     Toolkit (Toolkit) with helpful strategies and information for symptom management.      We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this     study. Recruiters will identify patients as they are prescribed oral cancer medications,     present the study to the patient, and ask them to consent to be part of the study.      Study Aims Following are the Aims of the study.        1. Cancer patients assigned to the intervention will have greater adherence to their          prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12 (sustained          effect).        2. When compared with patients receiving weekly assessments only, patients receiving weekly          assessments plus daily adherence reminders and printed symptom management strategies for          4 weeks will report: lower symptom severity during weeks 2-4 that will be sustained at          weeks 5-8, and at 12 weeks.      Two exploratory aims are assessed:        1. To test how patient characteristics (age, sex, depression), dose variation, symptom          severity, and concurrent infusion therapy moderate the impact of the novel intervention          on adherence at 4, 8, and 12 weeks.        2. To test the impact of the novel intervention on dose alterations, emergency department          visits and hospital admissions over the 12 weeks in order to support the translation of          this system into oncology practices.   "
94960|NCT02043171|"     Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is     accompanied by a loss of muscle function which can lead to diminished quality of life and     more importantly can lead to serious fall requiring medical treatment. The investigators     hypothesize that the combined supplements of Calcium-HMB and Vitamin D will lead to decreased     falls and to improved quality of life (QOL) for older adults. The investigators further     hypothesize that the addition of a modest exercise regimen to these supplements will enhance     the synergistic effects of both Calcium-HMB and Vitamin D.      Subjects will consume the dietary supplement 2 times per day for 12 months. Tests will     consist of the following: a) strength of subjects' legs and elbow by Isokinetic Dynamometer;     b) body composition; c) hand-grip strength by hand-grip dynamometer; d) functional mobility,     balance and agility (Get-Up and Get-Up-and-Go tests); e) filling out questionnaires; and g)     having blood drawn for biochemical measurements. Testing will be performed at the baseline (0     months) and at 3, 6, 9, and 12 months.   "
94961|NCT02043158|"     The goal of this research study is to learn about diet and exercise habits, emotions, and     social support in the lives of women with ovarian cancer.   "
94962|NCT02043145|"     This post marketing surveillance study in Korea will evaluate the safety and efficacy of     BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of     care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar     lines in clinical practice.   "
94963|NCT02043132|"     To the Investigators' knowledge, TXA has not been studied in the setting of reverse total     shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing     perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this     study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates     in patients undergoing reverse total shoulder arthroplasty.   "
94975|NCT02042976|"     The purpose of the study is to determine the efficacy of mindfulness-based cognitive therapy     (MBCT) as an add-on to pulmonary rehabilitation (treatment as usual, TAU) in chronic     obstructive pulmonary disease (COPD).      The investigators hypothesize that compared to treatment-as-usual, the add-on of MBCT will     result in improved psychological (anxiety, depression) and physical outcomes (physical health     status, activity level, inflammatory markers). Furthermore, the investigators will explore     the possible moderating role of individual differences in sociodemographic and     disease-related characteristics and the perceived quality of the therapeutic alliance, as     well as the mediating role of mindfulness, breathlessness catastrophizing, self-efficacy, and     self-compassion for the hypothesised effect.   "
94976|NCT02042963|"     KNOW-KT (KoreaN cohort study for Outcome in patients With KT: A 9-year Longitudinal cohort     study of the Korean adult KT patients), funded by Korea Center for Disease Control and     Prevention (KCDC) was established in 2012 by a group of transplant physicians, transplant     surgeons, nephrologists, epidemiologists, and biostatisticians in Korea.      We aimed to establish an adult KT cohort, to investigate the renal allograft outcomes,     mortality, complications, and to explore traditional or nontraditional risk factors for     morbidity and mortality. We established a bio-bank to integrate clinical and biological     information. Here, we report design and method of the KNOW-KT.   "
94964|NCT02043119|"     Currently, healthy mothers willing to breastfeed their babies are discharged from the     hospital on an average 2 days after a vaginal delivery or 3.5 days after a C-section, at a     time where breastfeeding is far to be well established. Following discharge, women can access     breastfeeding support from Public Health Units, lactation consultants, health care providers,     and Internet (e.g. from breastfeeding associations). Despite the current support, duration     and exclusivity rates of breastfeeding drop precipitously in the first weeks and months after     birth.      We have obtained funding from the Ontario Ministry of Health and Long Term Care to evaluate     the efficacy and cost effectiveness of a post-partum clinic based in the community. This     clinic, staffed by a family physician (in the morning), a registered nurse and a lactation     consultant, will provide breastfeeding support during the first month after delivery as well     as ensure a safe transition from hospital to the community for mothers and newborn babies.     The clinic, affiliated with TOH, will be found at Harmony Medical Centre, 152 Cleopatra     Drive, located south-west of downtown, a 15 minute drive from the Civic campus and 20 minutes     from the General campus. The Harmony Clinic has abundant parking (free on the street or a     small fee inside the associated lot) and is fully accessible.      In its initial phase, the future clinic would enroll only women willing to participate in a     research program to evaluate this new program. The clinic will be opening in November 2013     and currently (July - October 2013) we are conducting a pilot study to test feasibility of     recruitment and test the surveys and database for this project. Women will be recruited at     the Ottawa Hospital (General and Civic campus) and randomized to either receive standard-care     or to be given access to the post-partum clinic and be discharged within approximately 24     hours following a vaginal delivery or 48 hours following a C-section. They will have an     appointment booked at the breastfeeding clinic within 48 hours after discharge for maternal     and neonatal care as well as breastfeeding support. Enrolled women will have access to     additional clinic visits for one month after delivery. Information will be collected from     their medical chart as well as through surveys that will be sent to them at 15 days, 30 days     and 3 months after delivery. We will compare the data and information on the experience of     women who attended the breastfeeding clinic and those who did not attend the clinic. With     this data we will be able to determine if this type of breastfeeding clinic is beneficial to     new mothers and their newborn babies and if it really does increase the exclusive     breastfeeding rate at 3 months (primary outcome).   "
94965|NCT02043106|"     Participants will be asked to complete three different tests (standing, stepping and assisted     walking) and will experience three different experimental conditions during each test. The     three conditions are types of vibratory plantar cutaneous stimulation, which include no     vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory     stimulation. In the first condition, participants will experience no stimulation applied to     any part of the body. In the second condition, a submaximal vibratory stimulus will be     delivered at 90% of the participant's threshold to the surface of the foot. In the third     condition, a supramaximal vibratory stimulus will be delivered at three times the     participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and     supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is     positive then this protocol will also be presented in incomplete spinal cord injuried     participants.   "
94966|NCT02043093|"     The purpose of this study is to evaluate the impact of the school-based Sources of Strength     program in reducing suicidal behaviors in the population of high school students and     determine how the program works (mechanisms of change). Sources of Strength trains diverse     high school students as Peer Leaders, who conduct school-wide prevention messaging activities     with ongoing adult mentoring designed to increase positive coping norms and practices,     help-seeking and increase youth-adult connections. Sources of Strength is expected to enhance     school coping practices, increase help-seeking among distressed and suicidal youth, and     reduce the number of students in the population who attempt suicide. A total of 40 high     schools in primarily rural and micropolitan regions of New York State and North Dakota will     participate in this study that uses a randomized wait-listed design.   "
94967|NCT02043080|"     This is a study to evaluate Xpert MTB/RIF as the first-line TB diagnostic test in     HIV-infected adults and pediatric patients as a means to obtain faster, more accurate TB     diagnosis.   "
94968|NCT02043067|"     This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV     clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).   "
94969|NCT02043054|"     There are recent advances in therapies for the treatment of Type 2 Diabetes Mellitus (T2DM)     which include the GLP1 analogues and the DPP IV inhibitors. Both of these therapies target     the incretin system using different methods to elevate/maintain circulating levels of GLP1 to     subsequently achieve improved blood sugar control. Interestingly, GLP1 analogues have been     reported not only to improve blood sugar control but to additionally induce weight-loss and     emerging experimental evidence has shown it may have beneficial effects on the heart's     structure and function. Due to the profile of this condition being a lot worse and younger     patients having greater CVD risk, a therapy offering multiple positive effects, in particular     the potential cardiometabolic effects, make this line of therapy attractive in this patient     population.      The aim of this research is to investigate the cardiometabolic effects of Liraglutide (GLP1     analogue) compared to that of its clinically relevant comparator Sitagliptin (DPP IV     inhibitor).   "
94970|NCT02043041|"     We will invite a convenience sample of up to 45 enrolled subjects to participate in an     optional, self-administered blood specimen collection procedure to determine optimal     procedures for collection.   "
94971|NCT02043028|"     To perform chest compression (CC) in the kneeling posture in hospital, we designed a stage     with stairs, named the 'kneeling stool', on which a CC performer kneels beside a patient on a     bed.This work is the validation study to demonstrate that the kneeling stool could be used     for high quality hospital cardiopulmonary resuscitation (CPR) with the kneeling posture. We     hypothesized that the quality of chest compression with a kneeling posture using the kneeling     stool is equal to or superior to CC with a standing posture using the height adjustment     mechanism of the bed.   "
94972|NCT02043015|"     The purpose of this study is to evaluate the acceptability and uptake of a combination     package of biomedical, behavioral and community-level HIV prevention interventions and     services for men who have sex with men (MSM) in South Africa.   "
94973|NCT02043002|"     Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an     active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is     primary seen in patients harboring a mutation in the EGFR. However, 10-15% of patients does     not harbor a mutation but respond as well. Identifying these patients is a problem and     methods are lacking.      Studies have shown that an early 18F FDG-PET might can predict response and outcome in these     patients, but further studies are needed to confirm these findings.   "
94974|NCT02042989|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of MLN9708 and vorinostat that can be given to patients with advanced solid     tumors. The safety of these drugs will also be studied.   "
94977|NCT02042950|"     The goal of this clinical research study is to learn if carfilzomib can help control relapsed     or refractory MCL. The safety of this drug will also be studied.   "
94979|NCT02042924|"     This is a pilot sub-study of patients receiving myeloablative transplant using total body     irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The     objective of this stub-study is to estimate the heterogeneity in cellular proliferation     (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using     whole body water-fat MRI) using positron emission tomography imaging. This will be used to     design future trials as well as to determine the feasibility of PET and MRI imaging.   "
94980|NCT02042911|"     The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day     intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic     leukemia.   "
94981|NCT02042898|"     TRICS-III is an international, multi-centre, open-label randomized controlled trial of two     commonly used transfusion strategies in high risk patients having cardiac surgery using a     non-inferiority trial design.   "
94982|NCT02042885|"     The purpose of this study is to determine the tolerability profile of OPB-111001 and to     determine the most suitable dose of OPB-111001 in patients with advanced cancer   "
94983|NCT02042872|"     In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on     preservation of regional and total skeletal mass (DXA).      Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI,     as evidenced by serial densitometry determinations (DXA).   "
94984|NCT02042859|"     The purpose of this study is to determine whether the use of an FDA approved endoscopic     bipolar catheter (EndoHPB) will ablate tissue in malignant tumors within the pancreatic     ducts.   "
94985|NCT02042846|"     The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying     ultrasonic energy. This provides an intimate bond between implant and bone delivering     immediate stability.      The purpose of this study is to evaluate the surgical and clinical outcome of the     SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.   "
94986|NCT02042833|"     This observational study will evaluate patients' perception of treatment with     erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis.     Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin     beta) will be followed for 6 months.   "
94987|NCT02042820|"     In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry     eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an     in vivo metric to measure inflammatory changes in the central cornea. The objective of the     current study is to assess inflammatory response changes in the peripheral cornea and the     conjunctiva by analyzing epithelial immune cell density and morphology in these areas and     then correlating the IVCM findings to clinical signs and symptoms to establish novel     objective imaging biomarkers.   "
94988|NCT02042807|"     To evaluate the effect of MCS® compared with placebo in reducing the risk of     biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of     treatment.   "
94989|NCT02042794|"     Liver resection is an operation to remove the diseased part of the liver. The liver is     supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75%     respectively of the total blood flow with 50% oxygen from each vessel. During liver resection     it is standard practice to clamp both vessels(Pringle's manoeuvre), so as to avoid bleeding.     Clamping both the vessels deprives the unaffected liver from nutrients required for survival.     Reinstating the blood supply causes further damage by pouring harmful substances into the     liver, which accumulate during the clamping. We hypothesize that not clamping the oxygen rich     hepatic artery will cause less damage to the liver.      Our aim is to compare the Pringle manoeuvre with portal vein clamping, to identify if the     latter will result in less tissue injury and thereby fewer complications. Initially we aim to     conduct a pilot study. The main objective is to ensure that patients can be successfully     recruited and that data capture is complete. The secondary outcomes will be development of     infective complications by 30 days following surgery, bleeding and blood transfusion     requirements, heart/chest complications, recovery of liver functions, growth of remnant     liver, death within 30 days following surgery, length of high dependency unit/hospital stay     and quality of life at 3 months after surgery.      There is published literature on the safety of this method and in the event of any     intraoperative problems, the procedure will be converted to the standard Pringle manoeuvre.     The Liver Unit at St James's University Hospital has four surgeons performing around 270     liver cancer resections per year, of which nearly 160 are for bowel cancer spread.     Considering the team's experience in research and liver surgery, we believe it is well placed     to conduct the trial in a safe and efficient manner.   "
94990|NCT02042781|"     This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused     PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the     study will explore whether PG545 exposure results in changes to chemicals produced by the     body that are associated with cancer growth and spread.   "
94991|NCT02042768|"     Peritoneal Dialysis (PD) is a commonly used treatment for end stage renal failure, and the     most commonly used dialysate contains unphysiological amounts of glucose, a high proportion     of which is absorbed. Recent analysis of the Global Fluid Study, has established that in     non-diabetic prevalent patients on PD a random glucose level is dependent on dialysate     glucose load and is a predictor of death. By utilising clinical data and additional     biosamples collected for the NIHR funded PD-CRAFT study, the investigators aim to confirm     this finding, define the relationship between dialysate glucose exposure according to     prescription regimes and glycaemia, define the most useful biomarker to monitor glycaemia ,     and establish the role that impaired insulin sensitivity plays in blood glucose levels.     Furthermore the investigators will explore the hypothesis that insulin resistance is     associated with disturbance of the carnitine/acetyl-carnitine equilibrium that might benefit     from intra-peritoneal carnitine supplementation.      PD-CRAFT is an observational cohort study of 3000 prevalent PD patients collecting detailed     clinical data, including glucose exposure and samples of dialysate. and blood which will be     stored in the UK BioCentre. Follow up is for up to 2 years or endpoint (death, technique     failure).      Multivariate regression will be used to establish determinants of the non-fasting blood     glucose and other measures of glycaemia, in particular different dialysis regimes, (e.g.     modality, dwell lengths, fill volumes, and dialysate type and concentration specifically     seeking to identify prescriptions that minimise the systemic effects) combined with measures     of insulin resistance. The investigators will establish whether blood glucose predicts     survival in an adjusted analysis (~300 endpoints needed) using Cox regression and explore the     relationship of other biomarkers to survival.   "
94992|NCT02042755|"     The principal objective of the study is to determine the visual acuity at far, intermediate     and near distances tested with optotypes at different distances from the eyes and tested with     defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.      Secondary objective will be to test the glare and contrast sensitivity.   "
95107|NCT02041234|"     Investigators aim to show that Roux-en-Y Gastric Bypass (RYGB) is superior to best medical     treatment in reaching well-defined treatment end points in Asian subjects of BMI 27-32 with     type 2 Diabetes (DM2). Investigators also hope to show that successful RYGB will reduce     resource utilization in the near term with similar projected reduction over the medium to     long term.   "
94993|NCT02042742|"     A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2.     Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with     3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an     8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the     consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The     endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical     markers), inflammatory markers and nutritional status were evaluated before and after each     phase. Previously a pilot study was completed with no placebo (n=30) to determinate the     effective dose of Functional Supplement.   "
94994|NCT02042729|"     The purpose of this study is to investigate the safety and pharmacokinetics of new patch     formulation (tape) of E2022 by conducting patch test.   "
94995|NCT02042716|"     Preterm birth and perinatal events related can interrupt microscopic maturation of the     developing white matter leading to diffuse injury and subsequent neurocognitive impairments.     Brain maturation can be studied using diffusion tensor imaging but is difficult to assess     early after birth, repeatedly and at the bedside. Supersonic Shear wave Imaging (SSI) could     be of interest in this clinical setting. This technique, already investigated in adults     (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.      Objective:      To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm     infants and to correlate to gestational age.      Methods:      SSI is a quantitative stiffness imaging technique based on the combination of a remote     palpation induced into tissues by the radiation force a focused ultrasonic beam and an     ultrafast ultrasound imaging sequence. Such ultrafast frame rates permit to track in real     time the displacements induced by the propagation of the resulting shear waves. For each     pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the     local shear elasticity (characterizing the stiffness in kPa). In this study, we will use a     new generation of ultrafast ultrasound scanners (Aixplorer®, Supersonic Imagine, Aix en     Provence, France) with a linear L10-2 probe (256 elements, 6 MHz) in neonates born between 25     and 40 weeks' gestation (n=100). Three separate acquisitions will be obtained for each area     of interest both on right and left sides and stiffness was measured using a unique ROI of 2.5     cm².   "
94996|NCT02042703|"     The purpose of this study is to use a special eye imaging technique, anterior segment optical     coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye     that helps you to see clearly by directing images of light onto the back of your eye) and     note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has     many ways of showing up in the eye, including the formation of deposits in the eye, shakiness     of the lens that can complicate cataract surgery, and a higher chance of developing a type of     glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure     exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the     eye without requiring contact with the eye. We will compare lens images of subjects with     exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts.     This type of imaging could be used in patients with known diagnosis of exfoliation syndrome     to track disease progression and see how they respond to possible treatments. We also hope     that with this imaging technology we can detect early changes in currently unaffected eyes,     which could be useful for predicting which patients may develop the disease.   "
94997|NCT02042690|"     The survival of adult patients with standard-risk acute lymphoblastic leukemia(ALL) need to     improve. We want to compare the efficacy of haplo-identical hematopoietic stem cell     transplantation (HSCT) with chemotherapy for adult(age:18-39 years old) ALL patients in first     phase of complete remission (CR1)   "
94998|NCT02042677|"     This evaluation is being conducted to determine user perception of a new flat one-piece skin     barrier compared to their normal barrier.   "
94999|NCT02042664|"     Glucagon-like peptide-1 (GLP-1) receptor agonist are new treatment of type 2 diabetes, they     lower blood glucose level (by enhancement of glucose-dependent insulin secretion and     suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing     of gastric emptying. Beneficial effects of GLP-1 and GLP-1 receptor (GLP-1R) agonists on     cardiovascular function have been suggested. They improve biomarkers of CV risk, decrease     systolic blood pressure, improve endothelial function and have beneficial effects on     myocardium. Nevertheless, few studies have analysed the effect of GLP1 treatment on     myocardial function in type 2 obese diabetic.      Myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes     mellitus. It was recently shown that 16 weeks of caloric restriction in obese patients with     diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac     output, normalized stroke volume, LV mass and normalized end diastolic volume), and diastolic     function. However, no study has evaluated the impact of Glucagon-like peptide-1 (GLP-1)     receptor agonist in obese diabetics on myocardial TG content.      Recent studies have suggested that increased epicardial adipose tissue (EAT) could be an     important risk factor for cardiac diseases. We and others have already evidenced a     correlation between the volume of epicardial adipose tissue and the presence or the severity     of coronaropathy. The impact of weight loss on the volume of EAT or the characteristics of     EAT is mostly unknown.   "
95008|NCT02042547|"     Before la surgery:      Transthoracic cardiac echography will be done systematically, to measure among other things     the size of the left atrium.      During surgery:      Surgery under extracorporeal circulation: tissue samples will be harvested from the right     atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before     declamping of the aorta (T1= post-ischemia sample).      Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG     (T0) and a second sample after CABG (T1).      In parallel with the harvesting of cardiac tissue, blood samples will be taken at different     times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the     anesthetists.      After the surgery:      Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an     observation notebook. The biological samples will be analysed immediately and the biological     data obtained will be recorded in the observation notebook.   "
95660|NCT02034019|"     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular     lens implantation.   "
95000|NCT02042651|"     Introduction:      Chronic pelvic pain with unknown pathology is a condition that affects both men and women.     the condition is defined as pelvic pain lasting for a minimum of 6 months without any known     etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity     extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount     of energy approximately 5 cm under the skin of the patient without damaging the skin. This     have been shown to increase blood flow and accelerate healing which could also be beneficial     in chronic pelvic pain patients.The purpose of this study is to investigate the effects of     LIESWT on chronic pelvic pain.      Methods:      All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.      The investigators anticipate to include 100 chronic pelvic pain patients in the study.      included patients will be randomized into two groups: active treatment or sham treatment.      All patients will be required to provide a urine sample and a semen sample prior to final     inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo     a digital rectal exploration and finally all patients is required to provide an informed     consent in order to be included in the study.      A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive     the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each     treatment consists of 3000 shockwaves applied to the perineum with a energy density of     0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.      Participants will fill out a questionnaire one week before the treatment, one week, four     weeks, and twelve weeks after the last treatment.      Possible gains from this study:      The investigators hope to provide further evidence for this treatment and consequently be     able to offer the treatment as an alternative to the very limited array of treatments     existing for this group of patients today.      Ethics, funding, and publication:      The study is performed in compliance with the Helsinki declaration. External funding have     been applied for but not yet received. Participants will be informed of sources of external     funding. The result of the study will be published as soon as possible, preferably in a     peer-reviewed international journal.   "
95001|NCT02042638|"     Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic     hypogonadism.   "
95002|NCT02042625|"     Low body temperature (hypothermia) is often observed in anesthetized patients. Mild     hypothermia increases complications such as surgical blood loss, postanesthesia recovery and     the duration of hospitalization. To assess body temperature and minimize hypothermia-related     complications, it is important to have accurate and reliable methods of measuring     intraoperative core temperature. Common practice is to insert a nasopharyngeal (back of the     throat from the nose) probe through one of the nostrils. However, there is no consensus or     guideline regarding how deep the nasopharyngeal probe needs to be inserted. This study is     being done to determine the insertion depth (or range of depths) that best approximates core     temperature, which is temperature of the vital organs, e.g. heart, liver and lungs.      Participation in the trial will occur on the day of surgery. The subject will be asked to     breathe through one nostril and then the other before receiving anesthesia. The less     congested nostril will be selected for study. If there is no difference, then the     investigator will use the right nostril.      Once under anesthesia, an esophageal temperature probe will be inserted to serve as a     reference core temperature, which is used routinely in surgery. Then the nasopharyngeal probe     will be inserted into the nostril.      Both nasopharyngeal and esophageal temperatures will initially be recorded 45 minutes after     anesthetic induction. The nasopharyngeal probe will then be withdrawn 2 cm and after a     3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be     recorded. The nasopharyngeal probe withdrawal sequence will be repeated, 2 cm at a time,     until only 2 cm remains in the nostril. There will be a total of 10 sets of nasopharyngeal     and esophageal temperatures obtained.   "
95003|NCT02042612|"     Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients   "
95004|NCT02042599|"     Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute     kidney failure   "
95005|NCT02042586|"     The investigators believe that the application of non-linear methods of analysis using the     ganglion and neural network technique will make it possible to analyse all of the complex     data obtained in patients with hip osteoarthritis before and then after total hip     replacement, and should allow us to identify a combination of objective variables to classify     the surgery as  successful  or  unsuccessful .      To this end, the study will take place as follows:      Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis     of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor     activity carried out between 6 months and 1 year after the THR Step 5: Data analysis   "
95006|NCT02042573|"     Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of     patients with depression, is responsible for a decrease in the expression of the C-FOS and     DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be     explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS     causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate     with the antidepressant effect [Hausmann, 2000].      According to this hypothesis, the genetic effect related to medical antidepressant treatments     deserves to be studied because we could observe:        -  either a decrease in the expression of the C-FOS and DUSP1 genes related to the          antidepressant effect of the medical antidepressant treatment,        -  or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral          activation due to the medical antidepressant treatment.      In summary, we wish to determine the validity of this hypothesis by comparing the genetic     effect of rTMS with that of medical antidepressants to know if:        -  this genetic effect is specific to rTMS or common rTMS and medical antidepressants        -  this effect correlates with the clinical improvement induced by rTMS and by medical          antidepressants        -  this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic          response to rTMS and antidepressants (early decrease in gene expression)        -  the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor          of therapeutic resistance to rTMS and/or medical antidepressants.   "
95007|NCT02042560|"     This is a multicentre, open, case/control study aiming to investigate in a quantitative and     functional manner the different populations of immune cells in auto-immune thrombopenia with:        1. Disturbed T lymphocyte response             1. TH1 response predominant over TH2 response             2. Implication of TH17 L             3. Quantitative and/or functional deficit of regulatory T L             4. Involvement anti-apoptotic mechanisms of TL        2. Disturbed B lymphocyte response             1. Hyperactivation of B lymphocytes and involvement of memory BL             2. Secretion of autoantibodies        3. Implication of ImC and disturbance of the pDC/mDC ratio        4. Study of splenic immune cells (TL, BL, DC)      The study will in no way modify the investigation procedures (diagnostic and therapeutic     strategy), which will be carried out as usual.      Blood samples related to the study will be taken in the context of a pathology investigation     and will not require an additional puncture.      Spleen samples will be obtained with the consent of the patient if therapeutic splenectomy is     planned, which is usually proposed to patients with ITP.   "
95009|NCT02042534|"     Rationale Acute ischemic stroke due to atrial fibrillation (AF) carries a high risk for early     recurrence. In acute stage, guidelines recommend aspirin, but do not recommend     anticoagulation due to the increased risk of intracranial bleeding. Since, aspirin has a     limited efficacy of preventing recurrent stroke in AF, expert consensus suggests early     anticoagulation in non-severe stroke with AF. The current practice for acute ischemic stroke     patients with AF is delayed warfarin administration with aspirin use for non-minor stroke or     immediate warfarin administration (sometimes with heparin bridging) for minor stroke.     However, conventional anticoagulation with warfarin in acute ischemic stroke with AF has the     following limitations: 1) risk of intracranial bleeding particularly in acute stage, 2)     delayed action and transient paradoxical thrombogenic tendency due to the inhibition of     protein C, resulting in the risk of early recurrent embolic stroke, and 3) prolongation of     hospitalization waiting for full anticoagulation. In contrast, as compared to warfarin,     rivaroxaban is advantageous for reduced risk of intracranial bleeding and immediate     anticoagulation efficacy.      Goal The current trial will examine whether early initiation (within 5 days from stroke     onset) of rivaroxaban as compared to conventional warfarin would reduce intracranial     bleeding, recurrent embolic stroke, and hospital stay in patients with acute ischemic stroke     due to AF.   "
95010|NCT02042521|"     The purpose of this study is to determine whether a dietary supplement (DS) is effective in     protecting against sad mood during early cigarette withdrawal. This study will also assess     whether the dietary supplement will be well tolerated during early cigarette withdrawal.   "
95011|NCT02042508|"     This single-centre study was carried out in collaboration with the Cardiovascular Research     Laboratory of Harvard University (Boston, USA). This preliminary study does not include a     control group.      The aim of this study was to investigate the effect of a hybrid reconditioning programme     (electrostimulation of the lower limb muscles associated with voluntary strengthening of the     upper limbs) on a specially developed rowing machine in patients presenting stabilized     paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic     capacity (VO2max) between the start and end of the 9-month reconditioning programme.   "
95012|NCT02042495|"     The investigators will explore the chemopreventive role of metformin. The purpose of this     study is to determine whether, among patients with endometrial cancer, treatment with the     currently approved insulin sensitizing drug metformin increases or decreases pathway     activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa     study of metformin to be used to the pre-operative period of women diagnosed with endometrial     cancer by comparing their endometrial biopsy specimens taken at their initial visit and after     4-6 weeks of treatment of metformin on the day of their surgical staging.   "
95013|NCT02042482|"     The purpose of this study is determine whether combination Q10 , L-carnitine and multivitamin     and mineral complex is effective in treatment of patients with low and intermidiate1-2 risk     Myelodysplastic syndrome   "
95014|NCT02042469|"     Enrollment of patients in CR may be impacted by their levels of awareness and attitude toward     participation. Our study aims at assessing the awareness and willingness to participate in CR     and identifying the barriers and influencing factors for participation.      A cross-sectional study was performed using an interview-based questionnaire composed of     close-ended questions conducted by trained research coordinators. Descriptive statistics,     univariate and multivariate analyses were applied.   "
95015|NCT02042456|"     This study is investigating whether automated whole breast ultrasound can improve detection     of cancer in breast cancer screening when used as a supplement to mammography or as a     supplement to digital breast tomosynthesis   "
95016|NCT02042443|"     This randomized phase II trial studies how well trametinib or combination chemotherapy works     in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot     be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin     calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It     is not yet known whether giving trametinib is more effective than combination chemotherapy in     treating patients with biliary or gallbladder cancer.   "
95017|NCT02042430|"     This pilot clinical trial studies epacadostat before surgery in treating patients with newly     diagnosed stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.     Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
95018|NCT02042417|"     We compare two POC-tests (INRario2 and CoaguChek) for the INR with the laboratory. Therefore,     we take bloodsamples (capillary and venous blood) and put it on the tool. After the     measuring, a number is shown = INR.      We develop a Bland-Altman-plot for the correlation between the tool value and the laboratory     value to illustrate the applicability in the clinical daily routine.   "
95019|NCT02042404|"     The EarLens System is an assistive hearing device that is intended to provide amplification     for the treatment of patients with sensorineural hearing impairment. The purpose of this     multi-center definitive study is to assess the safety and efficacy of the EarLens System for     subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully     activated system in their daily lives for a 4 month period of time. This study is designed to     support US and International marketing applications to commercialize the EarLens System. The     main efficacy hypothesis is that the EarLens System will be shown to improve speech     understanding in quiet.   "
95020|NCT02042391|"     Post-transplant lymphoproliferative disorders (PTLD) differ clinically from lymphoma in the     general (immunocompetent) population due to their higher incidence and their frequent     association with Epstein-Barr virus. Previous clinical trials have shown their remarkably     good response to rituximab as well as to chemotherapy.      The PTLD-1 trial demonstrated the efficacy and safety of sequential immunochemotherapy with 4     courses of rituximab IV followed by 4 cycles of CHOP chemotherapy. Compared to trials of     rituximab monotherapy in PTLD, median overall survival was extended from 2.4 to 6.5 years.     Compared to previous trials of chemotherapy, complications were reduced. In addition, we     noted that those patients who already had a good response to the first four cycles of     rituximab did better overall than those who did not. As a consequence, the PTLD-1/3 trial     introduced risk-stratification in sequential treatment according to the response to the first     4 courses of rituximab monotherapy. Those patients with a complete remission went on to     receive four further courses of rituximab whereas those who did not received rituximab and     CHOP chemotherapy. Interim results have demonstrated that it is safe to restrict chemotherapy     treatment in this manner and thus established the concept of treatment stratification based     on the response to rituximab.      The PTLD-2 trial is the next step in the development of this strategy. Compared to the     PTLD-1/3 trial, the key difference is the use of subcutaneous instead of intravenous     rituximab application. Interim results from an ongoing trial of patients with follicular     lymphoma (NCT01200758) have shown that subcutaneous administration results in increased blood     levels and in non-inferior remission rates. Furthermore, the stratification strategy is     refined based on observations from the previous PTLD-1 and PTLD1/3 trials: Risk groups are     now defined not only based on response to rituximab therapy but also on the international     prognostic index (IPI, a well-established lymphoma risk score) and the transplanted organ.     The major advantage of this new stratification is an extended low-risk group that is eligible     for subcutaneous rituximab monotherapy: Patients with a low risk of disease progression,     defined as those who achieve a complete remission after the first four courses of     subcutaneous rituximab monotherapy and those with an IPI of 0 to 2 who achieve a partial     remission at interim staging, will go on with rituximab monotherapy. Patients with high IPI     who achieve a partial remission, patients with stable disease at interim staging and     non-thoracic transplant recipients with progressive disease at interim staging will be     considered high risk. These patients will go on with 4 cycles of rituximab plus CHOP     chemotherapy similar to the PTLD-1/3 protocol. Thoracic transplant recipients refractory to     rituximab will be considered very high risk and will go on with rituximab subcutaneous plus     alternating chemotherapy with CHOP and DHAOx.      The trial hypothesis is that the new protocol will improve the event-free survival, a measure     integrating unfavorable events such as death, disease progression and treatment     complications, particularly infections, in the low risk-group compared to the results of the     PTLD-1 trial. In very high-risk patients data from the PTLD-1 and PTLD-1/3 trial have shown     that the current treatment is not sufficient to control the disease. Death due to disease     progression was observed in more than 80% of patients. Here, rituximab combined with     alternating chemotherapy cycles of CHOP and DHAOx (+GCSF) may increase treatment efficacy     with an acceptable toxicity profile.      In summary, the PTLD-2 trials tests if the substitution of subcutaneous for intravenous     rituximab and an updated stratification strategy that deescalates treatment for those at low     risk and escalates treatment for those at very high risk can further improve the overall     efficacy and safety of PTLD therapy.   "
95021|NCT02042378|"     The purpose of this study is to determine whether oral rucaparib is effective in the     treatment of patients with locally advanced or metastatic pancreatic cancer and a known     deleterious BRCA mutation.   "
95022|NCT02042365|"     The primary purpose of the study is to test the feasibility of a protocol of enhanced     recovery after surgery for reducing the total length of hospital stay in a large scale     setting   "
95023|NCT02042352|"     The primary aim of the present study is to investigate the vaginal microbiota of infertile     women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and     a PCR method supported with conventional Gram staining.      We hypothesize that the molecular based tests will prove more efficient than conventional     Gram staining and that they have a place in future IVF diagnostics.   "
95024|NCT02042339|"     Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient     pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an     increase of total oxygen in the body. The elevated tissue levels of oxygen may persist for     hours, instigating healing processes in wounds caused by disturbances in of perfusion in     small vessels, a condition often found in patient with diabetes.      We plan a prospective, double-blind randomized clinical study in 80 patients with chronic     diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO     at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be     identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number     of monitoring and imaging procedures will be done, cells in the bloodstream indicating     improved healing will be determined.      Hypothesis: HBO will instigate the healing process in the majority of patients with chronic     diabetic leg ulcer, provided the patency of the large vessels is given.   "
95025|NCT02042326|"     The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to     decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).      Sirolimus has properties that reduce the activity of the immune system (immunosuppressant),     to fight against the proliferation of cancer cells (anti- tumor) and also reduce the     proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant     patients to prevent organ transplant rejection. Many animal and laboratory studies were     carried out and demonstrate in particular the activity of sirolimus on vessels. It is this     anti- vascular effect that could help treat arteriovenous malformations.   "
95026|NCT02042313|"     Esophagectomy is a major surgical procedure often associated with significant morbidity and     mortality and significant level of postoperative pain. In contrast to open esophagectomy     where epidural pain control has been considered as a gold standard and could be crucial in     affecting outcome the analgesic scheme for minimally invasive esophagectomy (MIE) is yet to     be established. We would like to compare continuous epidural analgesia and continuous     paravertebral block combined with single shot subcostal transversus abdominis plane (TAP)     block in the analgesic effects, levels of cytokines, and postoperative complications in     patients receiving MIE.   "
95027|NCT02042300|"     The purpose of this study is to evaluate effectiveness and safety of XIENCE xpedition/Alpine     in Routine Clinical Practice   "
95028|NCT02042287|"     Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age.     Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and     homogenous and has a fishy smell especially after intercourse. It is of importance to treat     women with BV, as this condition is associated with serious risks, such as an increased risk     of preterm birth in pregnant women, and particular vulnerability to the acquisition of     sexually transmitted disease (STD). The pathophysiology of BV consists of changes in the     microbiologic composition of the vaginal flora. The treatment of choice for BV is oral     metronidazole for 7 days. Although the available antibiotic therapies produce good results in     the short term, symptomatic BV persists or recurs at 3 months in up to 50% to 70% of     patients, with long-term recurrence approaching 85%. An alternative treatment option may be a     vaginal acid gel which aims to optimize the vaginal milieu. The aim of this pilot study is to     assess the efficacy of Gynofit® vaginal gel (lactic acid and glycogen) compared to oral     metronidazole in the treatment of BV.   "
95029|NCT02042274|"     Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide     cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of     fish oil supplements has been reported to reduce blood triglyceride levels, and influence     glucose homeostasis and whole-body inflammation. However, recent evidence highlights     important gaps in our understanding with respect to the impact of fish oil supplements on     health; specifically, not everyone responds to these supplements in the same manner. The goal     of this research is to explore how an individual's genetic make-up may modify their response     to fish oil supplements.   "
95030|NCT02042261|"     Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs,     individualized therapy using plasma drug concentrations and minimal inhibitory concentration     (MIC) determination may be of importance. This concept is defined as therapeutic drug     monitoring (TDM).      In this pilot study our hypothesis is that the ratio between MIC and drug concentration data     is correlated to the bacterial load measured as time to positive liquid culture (TTP).      In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with     pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis     will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12     weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained     at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate     samples. Clinical follow up according to WHO criteria will be performed 1 year after     completion of treatment.   "
95031|NCT02042248|"     The purpose of this study is to:        -  find out the intensity and duration of the immune response after multiple injections of          the investigational study product AGS-004 made from one's own dendritic cells and one's          own strain of HIV;        -  understand the changes in the body's HIV DNA , and HIV-1 RNA in peripheral and resting          CD4+ cells prior to and following administration of AGS- 004.        -  find out if low levels of HIV virus that are not detectable by standard HIV RNA assays          will decrease following the administration of AGS-004.        -  find out if it is safe to give individuals with HIV multiple injections of AGS-004 made          from the person's own dendritic cells and their own strain of HIV.        -  find out if administration of AGS-004 decreases the amount of latent HIV infection in          resting CD4 cells   "
95074|NCT02041663|"     Use of brain natriuretic peptide to evaluate the cardiac function in the course of     meningococcal septic shock or severe sepsis.   "
95075|NCT02041650|"     This protocol describes a pilot study intended to test the hypothesis that patients with     acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective     antithrombotic treatment without stent implantation, thereby avoiding both early and late     complications related to percutaneous coronary intervention (PCI).   "
95076|NCT02041637|"     The purpose of the study is to evaluate the outcome and to determine predictive factors of     patients admitted in a context of acute liver failure without identified cause.   "
95032|NCT02042235|"     In studies of children born at term, language delay at the age of 2 years exhibits a     spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no     recommendation for speech therapy before the age of 3 years. However, for term-born children,     parent-implemented language interventions conducted during the third year of life have     already shown a positive short-term effect on language skills. In these interventions, a     skilled interventionist, generally a speech therapist, teaches parents how to use specific     language strategies with their child.      The investigators' hypothesis is that such parent-implemented interventions would be     particularly appropriate at short and medium term for the improvement of linguistic     performances in very preterm children, a population with a high prevalence of early language     delay. Currently, there is an opportunity to partly nest an intervention trial in a national     prospective population-based cohort of very preterm children, the EPIPAGE (Etude     EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies     born alive in France in 2011. This situation provides considerable methodological advantages.   "
95033|NCT02042222|"     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This     can result in painful episodes, serious infections, chronic anemia (a decrease in the number     of red blood cells), and damage to body organs. Hydroxyurea therapy offers significant     benefits for infants, children, and adolescents with sickle cell anemia. These include a     reduction in the frequency of pain crises and acute chest syndrome (inflammation of the     lungs) and an increase in hemoglobin (the oxygen-carrying protein) in the blood. Patients on     hydroxyurea who receive a maximum tolerated dose (MTD) that is specific for them have greater     clinical benefit than those who receive a standard lower dose. There is, however, no way     currently to predict the MTD for individual patients. As such, MTD for each patient is     currently determined by gradual increases in the dose over several months. This process is     time-consuming, requires monthly clinic visits, and delays the benefits of hydroxyurea     therapy.      Our research group has come up with an equation that could be used to predict each patient's     MTD using baseline clinical and laboratory measures before starting hydroxyurea treatment.     The purpose of this research study is to compare the use of our equation for predicting MTD     to the current standard practice of gradually increasing the hydroxyurea dose until MTD is     reached. We want to see if the use of our predictive equation will allow us to achieve MTD     faster and with no more side effects than with the standard practice.   "
95034|NCT02042209|"     Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious     illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality     remains high: half of the deaths occur during the first two hours. The benefit of an early     diagnosis of ACS in term of morbidity and mortality is well established. Identification of     the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital     emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is     thus a key element of the prognosis.      The aim of the study is to build a telephone predictive score of ACS at the triage of calls     for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will     authorize the validation of a unique score or two distinct scores for men and women.   "
95035|NCT02042196|"     As women get older and go through menopause, levels of the female reproductive hormone     estradiol decrease to low levels. Also with aging, the functioning of the arteries declines.     Over time this vascular dysfunction can lead to health problems such as high blood pressure     and heart disease. This study is being done to help determine what causes arteries to become     unhealthy in postmenopausal women, who have low levels of the female reproductive hormone     estradiol. In this study we will test whether low levels of tetrahydrobiopterin (BH4), a     natural substance in the body that can cause the arteries to expand, explains why arteries     become unhealthy in women with low levels of estradiol. To answer this question, we will     study how vascular function changes with a medication that causes a short-term increase in     BH4 levels when estradiol is lowered with a medication, compared to when estradiol is normal.     We will also determine whether the administration of the antioxidant vitamin C, along with     the medication to increase BH4 levels, will normalize vascular health in perimenopausal and     postmenopausal women, and in women who have their estradiol levels lowered.   "
95036|NCT02042183|"     A study of the efficacy and safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to <     18 years diagnosed with Functional Constipation   "
95037|NCT02042170|"     The purpose of this study is to assess dosing requirements and establish the efficacy of     SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as     multi-center, randomized, active comparator-controlled, parallel, open-label.      45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of     daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the     other arm received daily hGH at 0.37 mg/kg/week.      Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And     patients randomized to daily hGH group injected for 6 days a week.      Patients visited study centers five times, firstly at screening (Visit 1), at randomization     (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for     follow-up (Visit5).   "
95038|NCT02042157|"     Our expectations (hypotheses) are:      Primary outcome        1. Regular bidet use will improve quality of life around elimination in adults with          impaired functional status. Functional status will be measured by activities of daily          living (ADL).        2. Regular bidet use by adults with impaired functional status will improve the quality of          life around toileting for their caregivers.           Secondary        3. Regular bidet use will reduce the incidence, frequency and severity of constipation (as          measured by self-report) in adults with impaired functional status.        4. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult          women with impaired functional status.   "
95077|NCT02041624|"     The purpose of the present study is to describe patient's perception of quality of life and     effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.   "
95078|NCT02041611|"     The primary goal of this study is evaluate T cell immune status and immune reconstitution and     the association with specific cytokines in patients with newly diagnosed HGGs undergoing the     standard RT/TMZ and adjuvant TMZ.   "
95079|NCT02041598|"     The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community     Health Worker (CHW) intervention to improve diabetic management and control among     Bangladeshis with diabetes in New York City (NYC).   "
95039|NCT02042144|"     This study is a prospective observational cohort study. The study will be conducted in     routine clinical practice settings. It is planned to enroll 1000 patients with metastatic     Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for     metastatic disease and for whom a decision has been made by the physician to treat with     regorafenib according to local health authority approved label. It is the aim of this     observational cohort study to further characterize safety and effectiveness of regorafenib in     routine clinical practice setting. Healthcare resource utilization in the routine provision     of care is becoming increasingly important from a health economics and outcomes research     perspective. Therefore, another aim of this observational cohort study is to capture     healthcare resource associated with the management of treatment emergent adverse events in     the real world setting. The primary objective of this study is to further characterize safety     of regorafenib use in routine clinical practice settings. The secondary objective of this     study is to assess the effectiveness of regorafenib in routine clinical practice settings as     measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate     (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.   "
95040|NCT02042131|"     The purpose of the proposed study is to identify the most effective brief interventions for     reducing short-term risk for suicide attempts in real world military triage settings, and     to identify potential mechanisms of change underlying the interventions' impact on subsequent     suicide attempts. We will randomize 360 patients to one of three commonly-used crisis     interventions delivered as routine care in the mental health triage system: (1) Treatment As     Usual (TAU); (2) Standard Crisis Response Plan (S-CRP); or (3) Enhanced Crisis Response Plan     with Reasons For Living (E-CRP). The following hypotheses will be tested:        1. The enhanced crisis response plan (E-CRP) intervention will contribute to significantly          decreased risk for suicide attempts and hospitalization during follow-up relative to the          standard crisis response plan alone (S-CRP) and treatment as usual (TAU).        2. The standard crisis response plan (S-CRP) intervention will contribute to significantly          decreased risk for suicide attempts and hospitalization during follow-up relative to          treatment as usual (TAU).        3. Greater ambivalence about suicide and faster recall of reasons for living will mediate          the relationship between intervention and reduced risk for suicide attempt during          follow-up.   "
95041|NCT02042118|"     The purpose of this study is to compare the use of a laryngeal mask airway (LMA) vs.     face-mask ventilation (FMV) during first-line neonatal resuscitation in Mulago Hospital,     Kampala, Uganda.   "
95042|NCT02042105|"     This is a post-marketing, observational, non-interventional, multi-central study of patients     with non-small cell lung cancer (NSCLC), with data collected prospectively from medical     records at inclusion. The primary objective is to obtain the epidemiologic data of anaplastic     lymphoma kinase (ALK)-positive in unselected Chinese patients with NSCLC.   "
95043|NCT02042092|"     This study is a cross sectional comparison of the Color Doppler Ultrasonography (CDUS) and     Magnetic Resonance Angiography (MRA) in patients diagnosed with sLVV. The supraaortic large     vessels (aorta, carotid, subclavian, vertebral, and axillary arteries) and the temporal     arteries of fifty patients suffering of sLVV will be examined by CDUS and MRA. The images     will be evaluated by 2 blinded experts (one for CDUS and one for MRA). In addition, the     intima media complex (IMC) thickness of the large vessels and temporal arteries will be     measured by CDUS in 100 sex and age matched controls to the sLVV patients. Blood samples from     patients and controls will be collected in order to perform genetic and cytokine analyses.   "
95044|NCT02042079|"     The purpose of this study is to evaluate the feasibility of endoscopic full-thickness     resection with laparoscopic assistance.   "
95045|NCT02042066|"     Low intensity shockwaves have been proven in animal and human studies to increase tissue     perfusion, promote angiogenesis and tissue regeneration and improve neural function.      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients     with resistant hypertension.   "
95046|NCT02042053|"     This study intents to provide an initial evaluation of the utility of positron emission     tomography and magnetic resonance (PET/MR) imaging measures for the prediction of     immunological response to Sipuleucel T (SipT) therapy.   "
95047|NCT02042027|"     The purpose of the study is to test the investigational drug Gamunex-C on the growth of blood     vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the Moran     Eye Center at the University of Utah.      The cornea is the clear outer front part of the eye. In corneal neovascularization, blood     vessels grow over the cornea. Corneal neovascularization and ocular anterior segment     inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent     scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is     also a well recognized risk factor for corneal graft failure. In its natural state, the     cornea is a site of immune privilege well suited to tissue transplantation. Once     vascularized, there is direct exposure of corneal antigens to circulating host immune     mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation     Study].      Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause     irreversible scarring or destruction of the optical elements of the eye, which can compromise     vision.      Current standard of care for such conditions includes use of topical steroids and sometimes     immunosuppressants (e.g., cyclosporine). These do not address a common underlying corneal     neovascularization or melting.      This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment     of corneal neovascularization in the setting of corneal transplantation with     neovascularization. Candidates for corneal transplantation with corneal neovascularization in     one or more quadrants crossing more than 0.5mm over the limbus will be identified for     inclusion in our study.   "
95048|NCT02042014|"     To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are     benefitting from treatment with QTI571.   "
95080|NCT02041585|"     The DC PROMIS Study (also known as the Discharge Patient Reported Outcomes Measurement     Information System Study) is a study to see the effect of patients' social, physical and     mental function on their health after hospital discharge.   "
95081|NCT02041572|"     The study has two goals. First to develop a computer-based intervention meant to alter     cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test     the intervention in a small sample of veterans for feasibility and acceptability.   "
95049|NCT02042001|"     Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been     associated with persistent central nervous system symptoms or mild or even asymptomatic     neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is     beneficial among patients who experience mild or asymptomatic neurocognitive/neuropsychiatric     adverse events during EFV has not been explored yet.      The proposed pilot study will examine whether switching from EFV-based regimen to single     tablet regimen TDF/FTC/RPV is associated with neurocognitive/neuropsychiatric improvement     among HIV-infected patients with mild/asymptomatic neurocognitive impairment or     neuropsychiatric symptoms during EFV-containing antiretroviral treatment.      Patients under stable treatment with EFV, confirmed HIV-1 RNA viral load < 50 copies/mL and     altered scores in depression, quality of sleep or anxiety tests and/or alteration in 1 or     more domains as assessed by neuropsychological assessment, will be randomized to immediate or     deferred (12 weeks) switch to TDF/FTC/RPV. Neurocognitive and neuropsychiatric tests will be     repeated after 12 and 24 weeks of follow-up and variations will be compared between groups.   "
95050|NCT02041988|"     In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce     opioids administration during major urological surgery   "
95051|NCT02041975|"     To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals   "
95052|NCT02041962|"     This study will determine if a version of the chronic care model for individuals with mood     disorders seen in small or solo practices can improve patient health.   "
95053|NCT02041936|"     The purpose of this study is to evaluate the short and intermediate term outcomes of the     NanoKnife Irreversible Electroporation System when used to treat unresectable pancreatic     cancer. In addition, the study will evaluate the efficacy of this device in treating symptoms     of unresectable pancreatic cancer. The NanoKnife, System has been commercially available     since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has     received FDA clearance for the surgical ablation of soft tissue. It has not received     clearance for the therapy or treatment of any specific disease or condition.      Irreversible electroporation (IRE) has the potential to dramatically widen the treatment     options for patients with pancreatic cancer. It provides a minimally invasive procedure that     could potentially avoid radical surgery for smaller lesions, and it could potentially offer     palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients with     locally advanced unresectable disease.   "
95054|NCT02041923|"     Premature infants are at high risk of suboptimal health and development. This randomized     clinical trial evaluated the impact of a developmentally based intervention, H-HOPE     (Hospital-home transition: optimizing prematures' environment), for infants born between     29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE     will improve infant behavior, mother care for the infants, mother-infant interaction and will     reduce health care costs.   "
95055|NCT02041910|"     Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia     affects about 1% of the male population and may be seen in up to 20% of male infertility     situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm     production severely disturbed to absent. FSH levels tend to be elevated (hypergonadotropic)     as the feedback loop is interrupted. The condition is seen in 49-93% of men with Azoospermia.     The purpose of this study is to assess the ability of bone marrow derived stem cells to     differentiate into germ cells and their role in treatment of testicular Azoospermia   "
95056|NCT02041897|"     It is still controversial about the necessity of endoscopy ultrasound guide fine needle     aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is     to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.   "
95057|NCT02041884|"     The purpose of this study is to further evaluate the treatment for adults with ADHD used in     our previous study (clinicaltrials.gov ID NCT01659164). It will now be converted to therapist     supported, internet-delivered cognitive behavioral therapy (iCBT) with an additional     smartphone application and evaluated through a randomized controlled trial during 12 weeks.     The patients will be randomized to one of three conditions        -  an active treatment group where the intervention is based on cognitive - and dialectical          behavioral therapy (CBT and DBT) and the mobile app.        -  an active ICBT-treatment based on psychoeducation, a CBT stress-reduction program and          Applied Relaxation, and        -  treatment as usual (TAU) / waiting list.      The main objective of the study is to evaluate if both of the treatment conditions will show     better outcomes than TAU regarding decreased ADHD symptoms and increased functioning and life     quality.      Another objective is to evaluate if the group receiving the active iCBT treatment (based on     CBT and DBT) will show better outcomes in comparison to the control group regarding ADHD     symptoms, overall functioning and life quality.   "
95058|NCT02041871|"     To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity     after liver resection for cancer.   "
95059|NCT02041858|"     Alarm fatigue, a lack of response to an alarm due to desensitization, is a national problem.     The problem of alarm desensitization is multifaceted and is related to a high false alarm     rate, poor positive predictive value, lack of alarm standardization and the large number of     medical devices with built in alarms in use today. Cardiac monitor alarms are intended to     notify the healthcare practitioner that a clinical crisis is imminent. However, hundreds of     physiologic monitor alarms occur on monitored units each day. As a result, practitioners are     highly vulnerable to alarm fatigue which has resulted in serious harm to patients and death     due to staff inattention from alarm signal desensitization. Research indicates that 80-99.4%     of monitor alarms are false or clinically insignificant. Alarm hazards is the number one     medical device technology hazard of 2012 and has been listed by ECRI (Emergency Care Research     Institute) among the top 3 medical device hazards for the past three years (ECRI, 2011).     Delivering actionable alarm information to care providers is challenging given the     significant number of false alarms.      Ideally, alarms should activate for events in greatest need of clinical attention without     increasing the risk of adverse patient outcomes. This is not the case with current monitoring     technology which is designed for high sensitivity and low specificity. Practitioners must use     clinical intuition for determining how conservatively alarms should be set to be most useful.     There is no research evidence to support how best to set alarms without affecting patient     outcomes.      Quality improvement studies performed at The Johns Hopkins Hospital have demonstrated that     the frequency of alarm signals can be reduced by more than 50% through an altered set of     alarm parameters. This reduction in alarm signals has lead to an increase awareness of alarms     that do occur as well as create a quieter, healing environment for patients. Although this     change was not associated with a noticeable increase in adverse patient events, this     important outcome was not rigorously studied.      The specific aims of this pilot study is to determine if decreasing the number of alarms by     using an altered set of alarm parameters has an effect on patient outcomes in an intensive     care unit.      This project may have a significant impact on patient safety. A decrease in noise at the     bedside may result in less distraction to caregivers and may have a positive effect on     patient recovery. It is expected that the altered set of monitor default parameters will     result in a decrease in audible alarms without increasing clinically significant adverse     patient events.   "
95060|NCT02041845|"     The majority of patients with limited disease small cell lung cancer (SCLC) experience     recurrent disease despite receiving concurrent chemoradiotherapy. New agents and     dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts     for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local     control and thus reduce the recurrence rate and prolong survival. Positron emission     tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone     scan. More precise localization of tumors leads to more accurate definition of target volumes     for TRT and reduce the radiation dose to normal tissue. A large proportion of patients     relapse and die within one and two year after therapy. Few patients survive longer than three     years. Thus, two-year survival is considered a clinically highly relevant measure of     efficacy.      The aim of this study is to compare two schedules of TRT with respect to local control,     progression free survival, overall survival, toxicity and health-related quality of life. In     addition patients who have the best outcomes and tolerate chemoradiotherapy will be     characterized (e.g. clinical characteristics, blood biomarkers, body composition).   "
95061|NCT02041832|"     Using implantable loop recorder the investigators wish to detect atrial fibrillation in high     risk patients and compare it to the results using conventional Holter monitoring. The     hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The     investigators want to detect those people so they can receive appropriate anticoagulation     treatment. The patients will get a comprehensive workup including ecg, echocardiography and     blood tests.   "
95062|NCT02041819|"     Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor     (EGFR),has been shown to be effective and safe in some studies with head-neck     cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety     than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus     nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The     investigators then initiated a phase II clinical trial with Nimotuzumab plus     Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced     esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.   "
95063|NCT02041806|"     The purpose of this study is to determine if Peripheral Nerve Block scoring systems are     effective in predicting the achievement of intra-operative anaesthesia and post-operative     analgesia.   "
95064|NCT02041793|"     This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage     for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure     will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary     outcomes will be complications, recurrence and cost analysis between the two methods.   "
95065|NCT02041780|"     The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or     associated, are effective methods to assess liver fibrosis in children.   "
95066|NCT02041767|"     The purpose of this study is to demonstrate the prostatic diffusion in significant     concentration of ertapenem achieved after a pre-operative single administration.   "
95067|NCT02041754|"     The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several     studies demonstrating their efficacy, we are conducting this study to look into the efficacy     and safety of this novel combination of three fibres, in appetite regulation, aiming to     reduce the appetite.   "
95068|NCT02041741|"     This study aims to assess the effects of two different types of interventions aimed at     increasing happiness in the Flemish general population as compared to individuals that     receive no intervention.   "
95069|NCT02041728|"     The investigators are going to test if it is possible to detect early dementia with the     digital game memory. The investigators are going to test 15 healthy people and 15 patients     with early dementia.      The test consists of playing the game memory several times. While playing, several     parameters are stored.      The investigators are going to test if any correlation can be found between these parameters     and the cognitive state of the person as tested by the Mini-Mental status examination.   "
95070|NCT02041715|"     Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending     dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.   "
95071|NCT02041702|"     The aim of this study is to assess the safety and efficacy of the SJM MRI conditional pacing     system in subjects undergoing Cardiac Magnetic Resonance Imaging.The study hypothesis is that     cardiac MRI scan will not affect the performance of the SJM MRI conditional pacing system     when special conditions are met. Comparing with the control group,freedom from MRI     scan-related complications and the electronic performances such as pacing threshold,sensing     amplitude should be similar.   "
95072|NCT02041689|"     Thousands of children are diagnosed with cancer each year, many of whom will achieve long     term survival due to advances in treatments and technologies. However, when a child is first     diagnosed, they are confronted with a wealth of new and unfamiliar medical information that     they must integrate in order to understand their diagnosis and treatment plan. Little is yet     known about how children with cancer experience learning about their diagnosis and treatment     in the hospital setting, or the individuals and materials that may help to facilitate the     child's developing understanding. This information could help to identify or guide     educational and supportive child life interventions to help children with cancer better     understand their illness and its treatment.      This observational study will collect data about how children currently learn about their     cancer diagnosis and treatment in the hospital setting. The interventions used do not seek to     change the health outcomes of the participants in this study. The observational data     collected may serve to improve how future patients learn about their cancer-related     diagnosis.   "
95073|NCT02041676|"     The main objective is to show by a randomised controled therapeutic trial comparing in two     parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the     duration of non invasive respiratory support in the group treated by chest physiotherapy as     compared to the control group. The secondary objectives are to evaluate the duration of     oxygen dependence, the duration of hospitalisation and the proportional advent of     bronchopulmonary dysplasia.      These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic,     treated by non invasive respiratory support after weaning off from mechanical endotracheal     ventilation benefitting form a social security system and for whom the appropriate parental     authority are non opposed.   "
95082|NCT02041559|"     Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid     rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone     reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal     ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of     remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect     in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The     purpose of this study is to investigate the remifentanil effect on renal function during     robot assisted prostatectomy.   "
95083|NCT02041546|"     Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in     newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change     the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or     bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes     in MAS.   "
95084|NCT02041533|"     The purpose of this study is to show that Nivolumab will improve progression free survival in     subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared     to chemotherapy   "
95085|NCT02041520|"     Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in     the prevention of complications in seropositive for HIV patients. However, they develop some     manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing     cardiovascular risk.      Clinical trials in general population and in patients on hemodialysis have demonstrated a     significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are     believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially     triglycerides. Also in general populations it has been described a benefit effect of omega 3     acids on oxidative stress.      Objective: to know the effect of omega 3 acids on different markers of oxidative stress in     seropositive HIV patients.      Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV     patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They     will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or     placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and     stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid     peroxidation products) will be evaluated.      Sample size was calculated according to different variables. We selected the biggest one     calculated for a difference in nitric oxide of 25% after treatment between groups and a     standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of     31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost,     a sample size of 35 per group was considered.   "
95086|NCT02041507|"     The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC)     appears to be related to the quality of the procedure, and the incomplete removal of lesions     has been shown to increase the subsequent risk of developing a colon cancer.      Some studies suggest that small polyps with advanced histology are more common in the right     than in the left colon (right colon proximal to splenic flexure, left colon distal to the     splenic flexure). The average size of polyps in the right colon with advanced pathology or     containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm,     P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to     right-sided polyps with advanced histology or that harbor malignancy. These presumptive     precursors of cancer are smaller and possibly more easily obscured by residual feces, and     more likely to be missed at colonoscopy.      Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water     immersion (WI), characterized by suction removal of the infused water predominantly during     the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction     removal of infused water predominantly during the insertion phase of colonoscopy.      In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI)     in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the     proximal colon.      In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis     that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC     screening patients. Confirmation of the primary hypothesis will provide evidence that WE     enhances the quality of screening colonoscopy.      We also hypothesize that WE may be more effective in detecting proximal colon adenomas than     WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal     colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for further     testing that WE may provide a strategy to improve prevention of colorectal cancer by     increasing detection of adenomas in screening colonoscopy.      Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases     of colonoscopy will be done by different investigators. The second investigator will be     blinded to the method used to insert the instrument, thus eliminating possible bias about     procedure related issues.      Several secondary outcomes will also be analysed.   "
95087|NCT02041494|"     Hernias are often treated using a prosthetic mesh to add support to the healing wound.     Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data     regarding which type of mesh to use is limited. The purpose of this study is to compare the     effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin     (called a biologic prosthetic), and one that is made in a laboratory (called a synthetic     prosthetic). This study will include some patients who have an infection in/near the hernia,     and other patients who do not have an infection. We expect the synthetic mesh to be     associated with a higher rate of early post-operative surgical site infection and fluid     collections (seromas), while we expect the biologic mesh to be associated with a higher rate     of recurrence.   "
95088|NCT02041481|"     This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given     together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with     advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more     tumor cells.   "
95090|NCT02041455|"     Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse     musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and     headache are also commonly associated with the syndrome .      Although the etiology of this syndrome is not well defined yet, it means involve multiple     mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid     and altered circadian variation in sympathetic - parasympathetic balance, consistent with     changes in sympathetic hyperactivity at night .      The immune - pineal system, formed by the integration of the adrenergic and immune systems     pineal gland, appears to be involved in the genesis of the dysfunctions found in     fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep.     Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in     patients with fibromyalgia.      The present study aims to evaluate the relationship of immune - pineal system in the process     of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that     participate in the pathophysiological process of this disease.   "
95092|NCT02041429|"     This phase I/II research study is evaluating a combination of drugs called paclitaxel and     ruxolitinib as a possible treatment for inflammatory breast cancer. Ruxolitinib is a newly     discovered drug that has been shown to block a pathway (called the IL6/JAK/Stat pathway) that     may be important in cancer, including breast cancer. Blocking this pathway may stop cancer     cells from growing. Ruxolitinib has been approved by the FDA for patients with bone marrow     disease, and this is the first study using this drug in combination with paclitaxel for     breast cancer. Paclitaxel (also called Taxol) is an FDA drug approved for breast cancer     patients. Paclitaxel works by blocking the small microtubules inside cancer cells and     preventing cell growth. Information from laboratory experiments suggests that ruxolitinib     might also have effects on breast cancer.These studies have shown that ruxolitinib may make     paclitaxel more effective.   "
95093|NCT02041416|"     The goal of this study is to determine the feasibility, reliability, and validity of     administering the Geriatric Assessment Tool using these two different computer based survey     platforms, REDCap and Support Screen. The development of a computer based Geriatric     Assessment Tool has the potential to improve research and clinical practice by providing an     efficient user friendly means to collect and analyze data for geriatric oncology patients.   "
95094|NCT02041403|"     An observational trial aiming to verify whether does any relationship exist between renal     resistive index and postoperative outcome in major high risk surgery   "
95095|NCT02041390|"     Endoscopic implantation of plastic or covered metal stents is widely used in a variety of     benign pancreaticobiliary diseases, including duct stricture, large or difficult stones, bile     or pancreatic juice leak, etc. There are some late-stage adverse events after stent     insertion, such as stent occlusion, proximal or distal migration, secondary duct injury and     failure of stent removal, etc. The longer the stents were inserted, more likely the adverse     events would happen.      Although the optimal time of stent placement has not been well established, it has been     recommended that plastic stent should be removed/exchanged within 3-4 months and covered     metal stent be removed within 6 months. However, it was not uncommon that patients with stent     implantation did not follow the recommendation of further stent management by endoscopists.      Many methods have been used to improve the adherence of patients in medical service. With the     advance of mobile technology and popular use of mobile phones, it was believed that the     patient-centered outcome could be improved by mobile telecommunication with the timely     support of a patient by a health professional. Thus we hypothesize that mobile technology,     reminding the patients the necessity of stent management in time by short message service     (SMS), might increase the patient adherence in patients with benign pancreaticobiliary     diseases after ERCP.   "
95096|NCT02041377|"     The purpose of this study was to determine if subjects who have diabetes can operate the     Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid     glucose results.   "
95097|NCT02041364|"     Fatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand     the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective     study with breast cancer patients receiving adjuvant chemotherapy.   "
95098|NCT02041351|"     There is clinical benefit of docetaxel administered to patients who have progressed to 3 or     more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using     docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic     responses are obtained that it never received taxanes.   "
95099|NCT02041338|"     There are no standard neodjuvant regimens adapted according to the different subtypes of     breast cancer. This is a phase 2, randomized study to evaluate several regimens in different     subtypes of breast cancer.   "
95100|NCT02041325|"     This is a research study to determine if the study drug lenalidomide will increase the body's     immune response, which is the body's response against infections or tumors, to hepatitis B     vaccine in patients with plasma cell diseases which include multiple myeloma, monoclonal     gammopathy of unknown significance (MGUS) and Waldenström's Macroglobulinemia. It is not a     study to see if lenalidomide is an effective treatment for plasma cell disease.      Participants in this study have multiple myeloma or other plasma cell disease and have never     been vaccinated with hepatitis B vaccine. One of the effects of the drug lenalidomide is to     alter the immune system and thereby increase immune response. It also has some effect against     cancer cells; therefore, in theory, it may reduce or prevent the growth of cancer cells.      In this study, one-half of the subjects will be chosen at random to receive the study drug     and the other half will take a placebo pill (a sugar pill that looks the same as the real     medication). This is a double blind study where neither the subjects nor the investigators     know whether the patient receives the study drugs or placebo pills. The effects of the active     drug lenalidomide will be compared to the effects of the placebo. The results from this study     will be also be compared with a similar but separate study to be done on individuals without     known disease.      This study expects to enroll 64 subjects and will be carried out at the Boston VA Healthcare     System and the Dana Farber Cancer Institute.   "
95110|NCT02041195|"     The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC)     injectable formulation of RM-493 in healthy obese subjects on mean percent body weight loss     and other weight loss parameters, as well as Pharmacokinetic (PK) profile. The study is     designed to evaluate the efficacy and tolerability of RM-493 administered once or twice     daily. The study drug (RM-493 and placebo) will be administered in a blinded fashion.   "
95111|NCT02041182|"     Pediatricians are supposed to talk about youth violence at all heath supervision visits,     however these types of conversations rarely occur. There have been no studies assessing tools     to prompt these discussions. The goal of this study is to see if electronic pre-visit     questionnaires (PVQs) prompt patient-provider discussion of youth violence (YV) in the     primary care setting. Additionally, patient-provider characteristics are explored as     mediators to youth violence discussions, as well as feasibility and acceptability of the PVQ     by patients and providers.      Adolescents ages 13 to 21 who come to the Hasbro Primary Care Clinics for annual physicals     will be recruited. A baseline phase was conducted to look at how often providers ask about     health-related teen behaviors, assessed by exit survey. The experimental period will involve     adolescents completing health-related behavior PVQ, given to their doctor prior to the visit.     Exit survey will assess topics discussed. Experimental group will differ from control group     based on PVQ containing extra questions about youth violence.   "
95112|NCT02041169|"     Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease.     Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is     primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues     demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD     patients induces a worsening of patients' symptoms and a severe limitation of their walking     capacity, contributing to an impairment of their quality of life. Despite maintaining a     sufficient walking activity is essential for these patients, LEPAD patients lower their     physical activity, which worsen the disease and potentially contribute to increase the risk     of cardiovascular events and deaths.      In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high     variability of the patients' walking capacity (i.e., walking distances between two stops     induced by lower limbs pain). Results suggested that in most patients previous stop duration     before each walk was a predictor parameter of this walking variability. Whether there is an     optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never     been studied.      This study is a prospective, cross-sectional study in exercise pathophysiology.      The main goal is to determine, following a walk that induces ischemia, the influence of the     recovery duration on the subsequent walking performance in LEPAD patients.      Secondary goals are :        1. To determine the nature of the relationship between the recovery duration and subsequent          walking performance.        2. To study the relationship between exercise ischemia, pain evolution and previous          recovery duration.        3. To determine whether the experimental procedure influence the determination of an          optimal of minimal recovery duration.        4. To study the influence of recovery duration on walking capacity from community-based          measurement.      It is expected to determine for the first time an optimal recovery duration that would     maximize the walking capacity of LEPAD patients.      In the medium term :        -  To give indications to the LEPAD patients to manage their pain in the community without          lower their physical activity.        -  To limit the functional decline of LEPAD patients.        -  To influence the quality of life and cardiovascular mortality. This would deserve          furthers studies.   "
95113|NCT02041156|"     The investigators' purpose is to study which exercise training modality: aerobic physical     activity in conjunction with either resistance training or balance training, is most     beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]).     Furthermore, our purpose is to evaluate the long-term effects of exercise training on     functional status, cardiovascular morbidity, blood pressure control, heart rate variability,     cardiac function, inflammation, body composition, nutritional status, progression of uraemia     and health related quality of life. This interventional study is prospective, randomized and     controlled comprising 150 prevalent and incident patients from our outpatient clinic.     Patients are invited to participate in the study consecutively, irrespective of basic     functional status. At start patients are randomised either to resistance or balance training     and the programme is adapted and individualised to each patient's actual physical status and     ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping     the intensity constant at a level of somewhat strenuous to strenuous on the Borg scale     rate of perceived exertion. The total observation period is 12 months with checks every four     months. Although exercise training is a recommended therapy in CKD, there is a lack of     medical and scientific evidence on optimal prescription. We hope that this study will provide     evidence-based knowledge on exercise prescription and its effects on various risk factors in     CKD patients. Finally, if patients achieve a higher degree of physical functional capacity     they should be able to maintain an autonomous lifestyle, resulting in considerable reductions     in societal costs for care and transportation.   "
95114|NCT02041143|"     This trial is an exploratory study in order to determine whether the ingestion of one type of     protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the     extension of the post-prandial window of anabolism during the night by increasing whole body     protein balance as well as muscle protein fractional synthesis rate (FSR).   "
95115|NCT02041130|"     Investigators will test a new approach to a form of heart failure (HF) with no current     treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have     preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These     stiff hearts pump strongly but fill inefficiently resulting in poor exercise capacity and     high death rates. Treatments that help when heart pumping action is poor are of no benefit in     HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the     kidneys (renal denervation; RDN) has been able to reduce BP in patients with high BP     resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys,     heart and circulation this treatment has promise in HF. The investigators will compare     effects of RDN and standard medical treatment on heart function, exercise capacity and     quality of life in 144 patients with HFPEF   "
95116|NCT02041117|"     1. It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of          Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing          LDL-C level to or less than 70mg/dl.        2. Ischemic stroke patients will be enrolled within 1 month after stroke onset.        3. Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.   "
95142|NCT02040779|"     This is a randomized, double-blind, placebo-controlled parallel-group study. Participants     will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage     of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI     placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators     will remain blinded to randomized treatment assignment during the study.      The study consists of 3 periods:        -  run-in period: Screening visit (SV) to randomization visit (RV), 14-21 days (2-3 weeks)          prior to study start        -  double-blind treatment period: RV through the final treatment visit, 85±3 days or 12          weeks after study start.        -  follow-up period: a follow-up visit/telephone call, 7±3 days after the treatment period          ends.   "
95117|NCT02041104|"     The purpose of this study is to investigate if daily consumption of barley beta-glucans     impact on lipid and glucose metabolism and on intestinal microbiota in a population with     metabolic syndrome. It is assumed that two month intervention with beta-glucans will improve     some clinical signs of metabolic syndrome and alter composition of intestinal microbiota.     Variation in microbiota composition will be investigated with emphasis on Bacteroidetes and     Firmicutes ratio. Furthermore it is presupposed that consumption of beta-glucans will     stimulate growth of beneficial intestinal bacteria from genus Lactobacillus and     Bifidobacteria and consequently effect production of short chain fatty acids in population     with metabolic syndrome. Moreover it is presupposed that two-month consumption of     beta-glucans will have influence on glucose metabolism and will consequently improve insulin     resistance within people with metabolic syndrome. It is assumed that two-month consumption of     beta-glucans will improve specific plasma lipid content in population with metabolic     syndrome.   "
95118|NCT02041091|"     The purpose of this study is to evaluate the amount of tabalumab in the blood after it is     given by two different injection methods - A traditional syringe or a spring loaded syringe     for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.   "
95119|NCT02041078|"     Intrahepatic division of the hepatic vein is associated with less blood loss than     extrahepatic dissection and division of the right hepatic vein.   "
95122|NCT02041039|"     Food aromas are a part of foods' flavor, and can promote overeating. Alcohol consumption also     stimulates appetite, and contributes to overeating while under alcohol's acute effects.     Knowing the brain regions that respond to food aromas and alcohol, and how they are modified     by the amount of body fat and alcohol exposure, will provide critical information about the     neural systems that underlie loss of control of eating. Therefore, the main hypotheses of     this study are that: A) Lean and obese subjects have different brain responses to food aromas     that enhance desire to eat, and B) Acute alcohol intoxication i) enhances the brain's     response to food odors, and ii) affects brain systems that inhibit or terminate eating. To     test these hypotheses, we have modified functional magnetic resonance imaging (fMRI)     paradigms successfully used to study alcoholic drink aromas in subjects at risk for     alcoholism.   "
95123|NCT02041026|"     We hypothesis that intake of probiotic yogurt reduces absorption of AFB1 in the gut and     subsequently reduce AFM1 and aflatoxins adduct, the biomarker in human urine and blood     respectively. We have demonstrated that yogurt made using weisella cibiria NN20 isolated from     fermented dough made from pearl millet in eastern part of Kenya sequestered upto 42% of     aflatoxin available in our invitro texts.   "
95124|NCT02041013|"     The research goal is to explore the use and effects of a custom-recordable audio discharge     instruction card (Talking Card) in the pediatric health care setting. This study will address     a primary, experimental research question: can pediatric asthma control be improved through     the distribution of a custom-recorded audio asthma instruction card to parents at the health     provider's office? Secondary, descriptive objectives will be to evaluate feasibility of     Talking Card delivery and to collect and summarize parental reactions to the design and use     of the audio discharge instruction card.      The specific aims of this study are:        1. To compare the change in mean Childhood Asthma Control Test (C-ACT) scores for children          aged 4 through 11 years with uncontrolled asthma receiving a custom-recorded asthma          instruction card to the change in mean C-ACT scores for those receiving usual care.        2. To measure the use and impressions of a custom-recordable audio asthma discharge          instruction card among primary caregivers of children with uncontrolled asthma through          quantitative and qualitative survey questions.      The investigators hypothesize that:      1) Asthma control in children 4 through 11 years of age with uncontrolled asthma, as measured     by the C-ACT, will improve to a greater extent among those receiving a custom-recordable     audio discharge instruction card than among those receiving usual care.   "
95125|NCT02041000|"     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the disease pathology of patients with     diagnosed with chronic obstructive pulmonary disease (COPD).   "
95126|NCT02040987|"     A thorough QT study of AZD3293   "
95127|NCT02040974|"     Our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the     symptom scores (RSS), visual analog scale (VAS) and medication scores (MS) and the impact on     quality of life with rhinoconjunctivitis quality of life questionnaire (RQLQ) in allergic     rhinitis patients sensitized to different allergens. Also the development of new     sensitizations and asthma during the immunotherapy were determined.   "
95128|NCT02040961|"     The double tube ETView is particularly innovative as it includes an integrated optical fiber     to visualize the carena. This study aims to verify if if its use avoids the requirement of a     fibreoptic bronchoscopy.   "
95129|NCT02040948|"     The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7     device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of     stroke volume (esophageal Doppler) to detect the response to a fluid challenge.   "
95130|NCT02040935|"     This single-arm, open-label, local multicenter study will evaluate the safety and     tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device     (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early     breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).   "
95131|NCT02040922|"     The principal research objective is to determine the impact of antibiotic use on the risk of     developing long term bowel symptoms after infection with the germ Campylobacter.   "
95143|NCT02040766|"     This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week     study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160     mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in     pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo.   "
95132|NCT02040909|"     Newborns admitted to an intensive care unit often require artificial ventilation. For that     purpose an endotracheal tube needs to be placed into the trachea, a procedure named     endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop     moving and to relax in order to enable the success of the procedure. For this sedation an     anesthetic agent named propofol is often used. The used dose of propofol has not been     properly studied and as a consequence patients are under- or over -sedated and propofol leads     to side effects such as hypotension.      The current study aims to find the most appropriate dose of propofol for newborns of     different gestational ages and of different post-natal ages. We will use propofol in     different doses and after each 5 included patients per age group we will analyze whether the     dose needs to be increased or decreased. The effect of the propofol will be extensively     monitored and we will study the level of sedation, the quality of intubation, the stability     of the patient en the occurrence of side effects.      At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.   "
95133|NCT02040896|"     The primary objectives are:        1. To investigate which healthcare workers and other individuals contribute to the decision          to order computed tomography (CT) scans for emergency department (ED) patients.        2. To investigate the specific reasons healthcare workers and other individuals order or          request CT scans for ED patients.        3. To determine the frequency of clinically important actions following CT scan results.      Once the drivers of ED CT utilization are identified, interventions including education,     incentives for compliance with evidence-based best practices, and interventions for     noncompliance could be targeted appropriately.   "
95134|NCT02040883|"     Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve     Cognitive function in Schizophrenia   "
95135|NCT02040870|"     A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics,     safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with     locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement. Patients must     have demonstrated progression during or after crizotinib treatment whether or not previously     treated with cytotoxic chemotherapy. Approximately 100 patients will be enrolled. For the     first 15 patients enrolled in this study, patients will have an additional 5-day PK run-in     period before treatment period. The pharmacokinetics profile of LDK378 in Chinese adult     patients with ALK-rearranged NSCLC will be evaluated.   "
95136|NCT02040857|"     This research study is evaluating a drug called Palbociclib in combination with endocrine     therapy as a possible treatment for hormone receptor positive breast cancer.        -  Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks          activity of two closely related enzymes (proteins that help chemical reactions in the          body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a          pathway, or a sequence of steps which is known to regulate cell growth. Laboratory          testing has suggested palbociclib may stop the growth of hormone receptor positive          breast cancer.        -  Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation.          During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor.          It is standard of care for premenopausal women to take tamoxifen and for postmenopausal          women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone          receptor positive breast cancer.   "
95137|NCT02040844|"     The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in     cat allergic subjects for up to five years after the start of administration of treatment.     The study is an optional follow-up study to a phase III double-blind, placebo controlled,     Cat-PAD study; no further investigational product is administered.   "
95138|NCT02040831|"     Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around     the world. This study will evaluate the safety and immune response to an RSV vaccine in     RSV-seronegative infants and children.      This study is a companion study to IMPAACT 2000.   "
95139|NCT02040818|"     Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream     infections that arise from the catheter. There are several management options for treatment     of such an infection, though the best option is not clearly delineated. Standard of care     options include exchanging the catheter for a new one over a guide-wire and instilling a high     concentration of an antibiotic directly into the catheter lumen. The investigators are     planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1.     Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new     one. Both these options have comparable cure rates as shown in the medical literature. After     obtaining informed consent, patients will be randomized to either treatment arm and will     continue to receive all other standard medical care.      Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel     antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is     non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related     bacteremia.   "
95140|NCT02040805|"     This study proposes to compare two forms of treatment for Hoarding Disorder (HD), a common     and impairing neuropsychiatric syndrome that has a profound impact on the lives and     functioning of individuals, families, and society. Specifically, we will compare a novel     community-based group treatment led by individuals from the community who are not mental     health professionals to the current standard of care treatment for Hoarding Disorder,     cognitive behavioral therapy, conducted by psychologists in a group setting. We hypothesized     that both treatment types will be similarly effective in reducing hoarding severity.   "
95141|NCT02040792|"     This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product     when administered once daily for 28 days using a jet nebulizer to patients with moderate to     severe chronic obstructive pulmonary disease.   "
95166|NCT02040467|"     The goal is to collect information on each patient treated with proton beam radiation     therapy.   "
95242|NCT02039479|"     The primary hypothesis of this confirmatory study is that lithium therapy will acutely     decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive     episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim     is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo     plus TAU, results in a significantly greater decrease in suicidal ideation and/or behaviour     over 5 weeks in inpatients with MDE.   "
95144|NCT02040753|"     In Denmark and the western world, there is an increasing prevalence of obesity probably due     to a combination of inadequate daily physical activity and a high energy intake. One approach     to achieve weight loss and change life style is to participate in an intensive supervised     prolonged life style modification course. The immediate effect is often positive, but over     time the overall effect is limited as the majority will not maintain weight loss and a     changed life style.      In this study we will analyse the results of the intensive lifestyle intervention as it has     been practised at Ubberup Folk High School over the last 13 years. As some people have     several stays at Ubberup Folk High School we want to we have a special interest in the effect     of repeated lifestyle intervention.      Research question:      What is the effect of several lifestyle interventions on weight loss maintenance?      The study design is retrospective and descriptive and will be based on a lifestyle     intervention, as it has practiced in a real life setting at Ubberup folk high school.   "
95153|NCT02040636|"     Primary objective:        -  To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed          combined with component pertussis and inactivated poliomyelitis vaccine grown on vero          cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with          component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV)          and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age.      Secondary objective:        -  To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at          11-14 years of age results in detectable immunologic interactions between components of          the two vaccines.   "
95154|NCT02040623|"     -  To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to          subjects evaluated by objective and subjective measures.        -  To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for          12 weeks to subjects.   "
95145|NCT02040740|"     An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23     (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children     are scarce. Currently it is assumed that meeting mineral requirements for the skeleton serves     the body's overall needs. However, it is not clear as to whether this is true, particularly     with growth. The contribution of dietary factors directly linked with the bone/kidney axis     through measurement of intake (via 24hr recall) and kidney nutrient clearance (via serum and     urinary analysis) will be included in investigations. Findings will serve as a springboard     for delineating more specific mechanisms by which these systems become disordered and are     influenced by diet. It is expected that adequacy of nutrients known to have a central role in     bone function will optimize the hormonal milieu through crosstalk with the kidney.      This effort will allow ongoing investigation in detecting and treating disturbances in     mineral metabolism related to kidney disease, specifically in the pediatric population and     broaden the understanding of kidney disease itself, as well as that of chronic diseases in     which kidney health is of importance, such as diabetes and osteoporosis. Findings of this     research may stress the importance of achieving dietary adequacy essential for establishing     optimal body composition trajectories, particularly puberty.   "
95146|NCT02040727|"     This project will evaluate the impact of resistance training on the synthesis and release of     hormones and growth factors from the musculoskeletal system and the extent to which the     communicative capacity influences glucose homeostasis In turn, the contribution of glucose     regulation on the musculoskeletal system will also be evaluated. This small study will serve     as a pilot/feasibility study to define a protocol for implementation of a resistance training     intervention in the pediatric population. To establish feasibility, this study population is     limited to overweight African American boys ages 7-11 years.      In light of well-established accolades of resistance training, historical recommendations for     avoidance among the pediatric population have deterred implementation of resistance training     interventions in young adolescents. However, contemporary data indicating a profound benefit     of resistance training to the skeletal system in pre-adolescents has led to the Academy of     Sports Medicine, as well as various other pediatric health interest groups, to support     supervised programs incorporating resistance training in young children, emphasizing large     muscle and core strengthening. To date, such trials have not been conducted in the pediatric     population   "
95147|NCT02040714|"     Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a     significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon     enough to have a sufficient number of patients from a single institution to perform a     definitive prospective study comparing the results of current treatments. The present study     will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP)     Disease and collect information regarding their presentation, treatment, and outcomes in the     course of receiving currently available treatments.      This study seeks to compare the outcomes of current treatments in the management of different     age groups (ages 1-6, 6—8, 8—11, >11) of patients with Perthes disease at two- and five-year     followup and at skeletal maturity. For each age group, two to three common treatment regimens     currently used by practicing pediatric orthopaedic surgeons will be compared. The     intervention a patient receives is determined through physician preference. Physicians pick     an intervention for each age group and treat each patient with the same intervention.   "
95148|NCT02040701|"     The purpose of the study is to measure markers of inflammatory and oxidative stress known to     be associated with cardiovascular morbidity in snoring children.      In addition, to measure markers of local inflammation and to evaluate the response to     treatment.   "
95149|NCT02040688|"     Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36     months of age. If left untreated, bedtime problems and night wakings can negatively impact     the daytime functioning and behavior of the child, as well as the entire family.      Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from     children with physiological difficulties in ingesting food, through picky eaters to full     fledged infantile feeding disorders.      We have recently shown that feeding and eating difficulties are more prevalent among children     with behavioral insomnia of childhood and that sleep problems are more frequent in children     with feeding disorders.      We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that     children with sleep or feeding disorder have increased rate of Sensory intergration disorder     (SID) compared with healthy controls.   "
95150|NCT02040675|"     The purpose of this study is to validate a novel method of diagnosing arrhythmias using the     NAVA catheter-positioning screen in patients who have a NAVA catheter in place.   "
95151|NCT02040662|"     Thoracic surgery correlates with significant pain in postoperative period. In order to     alleviate the pain various combinations of pharmaceuticals and administration methods are     employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain     various operation techniques are used. In traditional thoracotomy epidural anesthesia remains     a golden standard. Epidural anesthesia however demands high skills to be performed correctly     and presents an increased risk of grave complications. In videothoracoscopic (VATS)     operations paravertebral blockade can be employed, yet there is no certainty if its efficacy     after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single     site study to test the hypothesis, that continuous paravertebral blockade is as efficient in     postoperative pain reduction as continuous epidural blockade and possesses a higher safety     profile.   "
95152|NCT02040649|"     Through many years, the standard care has been to use continuous sedation of critically ill     patients during mechanical ventilation. However, preliminary randomised clinical trials     indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA     trial is an investigator-initiated, randomised, clinical, parallel-group, multinational,     superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway     and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical     ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at     trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation     on posttraumatic stress disorder after discharge from ICU.      Our hypothesis is that critically ill patients who are not sedated during mechanical     ventilation will have less posttraumatic stress disorder after discharge.   "
95155|NCT02040610|"     This study is being proposed to evaluate the use of moderate hypofractionated proton therapy     in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as     gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to     conventional proton therapy regimens. It is thought that this regimen will produce comparable     findings and would result in substantial health care cost savings, as well as, be more     convenient for patients.   "
95156|NCT02040597|"     The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after     single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with     different level of renal impairment in comparison with matching healthy volunteers. Moreover,     the safety and tolerability of the study drug will be also evaluated.   "
95157|NCT02040584|"     Assuming greater efficacy in the prevention of acute rejection in the EVR arm with     minimisation of TAC levels, the hypothesis of the present trial is that the introduction of     EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function     compared with standard therapy with TAC-MMF.   "
95158|NCT02040571|"     The overall aim of the study is to evaluate the performance of Artificial Pancreas or Closed     Loop Glucose-Sensing Insulin-Delivery system in comparison to current best available     technology represented by Sensor Augmented Pump Therapy (SAPT) in patients with Type 1     Diabetes.   "
95159|NCT02040558|"     This is a multicenter, open-label, dose escalation study of MNK-010 in subjects with advanced     solid malignancies who have failed conventional therapy. The safety, tolerability,     pharmacokinetic (PK) profile, and preliminary antitumor activity of ascending doses of     MNK-010 will be evaluated in subjects with advanced solid tumors.   "
95160|NCT02040545|"     This study aims to determine the performance of a salivary hormone competitive immunoassay     for monitoring patients during treatment for infertility.   "
95161|NCT02040532|"     The broad goal of this study is to obtain pilot data to determine the tolerability and     preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime     vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at     night in peri- and postmenopausal women. We hypothesize that the majority of participants     will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of     nighttime VMS will improve on low-dose gabapentin dosed at bedtime.   "
95162|NCT02040519|"     Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive     bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to     conservative treatment. Success rates range from 70 to 80%, and good long-term results are     reported. The working mechanism of SNM is not completely understood, and the only prognostic     factor for good response to this treatment is a successful test stimulation period. There is     no consensus on the duration of this test stimulation period. The experience in our clinic     during test stimulation period is that for responders it takes up to one week to achieve     maximal effect, after the system is turned 'on'. On the other hand the investigators notice     that after turning the neuromodulation system 'off', it will take a few hours for symptoms to     return to the baseline situation. The fact is: no information concerning the so called time     of onset and time of offset (or popular called: wash-in / wash-out) of sacral     neuromodulation is available in current literature.   "
95163|NCT02040506|"     This study will examine the safety and tolerability of IGN523 administered as an IV infusion.     The main purpose of the study is to determine the maximum tolerated dose (MTD), which is the     highest dose that does not cause unacceptable side effects of IGN523 in patients with acute     myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities     (the side effects that prevent further increases in dose) of IGN523. In addition, the     pharmacokinetic profile and anti-leukemia activity of IGN523 will be assessed. A recommended     Phase 2 dose (RP2D) of IGN523 will be identified, on the basis of safety, pharmacokinetic     (PK), and pharmacodynamic (PD) data.   "
95164|NCT02040493|"     This is a physician sponsored multi-center, non-randomized, prospectively enrolling data     collection study of patients with early stage breast cancer treated with electronic     brachytherapy at the time of surgical resection of the cancer in the operating room. The     radiation therapy treatments will be administered with electronic brachytherapy using the FDA     cleared Xoft Axxent System.   "
95165|NCT02040480|"     This study is being conducted to measure the relative bioavailability of the original gelatin     capsule formulation and a new formulation, immediate release (IR) tablet of Afuresertib     (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up Periods. A     subject's total time involved in the study will be approximately 9 weeks. The study will     enroll approximately 18 healthy volunteers.   "
95167|NCT02040454|"     The objective of this study is to evaluate the safety and effectiveness of the use of     intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous     dialysis access fistula stenosis.      A fistulogram will be performed in standard fashion. The diagnostic component will include     evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or     graft, plus venous return up to the heart. The location, vessel size, lesion diameter and     percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at     this point.      All patients will then receive standard therapy for their stenosis. This will include     intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond     poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations)     will be stented. Stent selection will be based on clinical setting. Initial stent treatment     will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include     initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard).     Documentation of location and type of treatment for each lesion treated will be recorded.      Once standard treatment is completed, the operating surgeon will be informed of the results     of randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, the     whole fistula vein outflow segment of the fistula will be treated with paclitaxel.      The full length of the radial artery from 1 cm of its origin to fistula anatomosis will be     treated with paclitaxel. In addition the anastomosis and first 4 cm of the fistula vein will     be treated. Paclitaxel solution treatment of each lesion encountered will be attempted until     the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter     and length of the vessels treated. Maximization of the length of vessel and lesions treated     will be undertaken when there are more lesions than can be accommodated by the 12 mg, 10 ml     dose available.      A 5 F sheath, 20 cm in length, will be used to administer the paclitaxel. This will be     advanced from its distal position in the radial artery over the guidewire so that the tip of     the sheath is in the proximal radial artery.      Prior to removal of the sheath, a final angiographic study of all areas treated is performed     to document patency and lesion appearance. Any additional lesions identified with this study     are then treated appropriately following standard technique.      For the control group, instead of paclitaxel administration, a sham treatment period of 10     minutes is allowed to elapse followed by the performance of the final completion angiogram.     Any additional lesions identified with this study are then treated appropriately following     standard technique.      All patients will follow the same follow up evaluation schedule   "
95190|NCT02040155|"     This is an observational study. The purpose is to determine the feasibility of using a novel     nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of     brachytherapy treatment. Women with gynecologic cancers treated with brachytherapy as part of     their standard therapeutic regimen will represent the study population.   "
95168|NCT02040441|"     This is a prospective, multicenter, randomized, double blind, placebo-controlled and a     prospective observational study.      This study will be conducted at 13 study centers in various European countries. Approximately     3500 participant between 18 to 75 years old with Type 2 diabetes mellitus and     normoalbuminuria will participate in the study. The study period is 3 years (excluding the 6     week screening period). Depending on the risk score of the urinary protein pattern,     participants will be stratified into an observational group or an interventional group.     Either 5 (low risk pattern, observational group) or 15 (high risk pattern, interventional     group) office visits of 1-3 hours duration are scheduled.      The interventional group will be allocated into one treatment group either receiving     spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The     allocation to one of the two treatment groups will be done by a random distribution procedure     established before the study start.      The results of the urine sample from the Screening visit has been analysed and the urine     proteomic pattern is determined to be either low- or high risk pattern and will determine the     further study program.      Participants with a low-risk pattern (observational group) (approximately 80%):      During the next three years, participants will attend an annual project visit, were regular     diabetes care will be performed and three urine samples will be analysed for albuminuria.      Participants with a high-risk pattern (intervention group) (approximately 20%):      Participants with a high-risk pattern will be randomization to either spironolactone     treatment or placebo. The treatment is one tablet for oral use to be ta en once a day for the     next three years. Four times each year (every 13th week) a study visit will be conducted     including examination of three urine samples for albuminuria.      This study aims to:        1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that          the urinary proteome test identifies patients with a high risk for development of          microalbuminuria.        2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in          high-risk patients can reduce progression to microalbuminuria in comparison to placebo,          on the top of standard treatment in a randomized double-blind, placebo-controlled          multicenter study.   "
95169|NCT02040428|"     The objective of this study is to evaluate the safety and effectiveness of the EVARREST™     Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.   "
95170|NCT02040415|"     The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to     eperisone HCl in efficacy and safety.   "
95171|NCT02040402|"     Pneumonia is one of the most prevalent diseases in infants and children. The incidence of     pneumonia in children less than 5 years old is about 34-40 cases per 1000 in Europe and     America and more than 2 million children die of pneumonia annually. It was reported that     Streptococcus pneumoniae accounted for 13%-53% of lower respiratory tract infections in     different age group of infants or children. In addition, 7%-9% of bacterial meningitis was     due to Streptococcus pneumoniae infection. In addition, children infected with Streptococcus     pneumoniae often transmit the pathogens to adult. As a result, it is evident that     Streptococcus pneumoniae presents a heavy burden to paediatrics practice.      Vaccination of 7-valent pneumococcal conjugate vaccines is effective in preventing     Streptococcus pneumonia .Routine use of PCV7 in the US has rapidly reduced rates of invasive     pneumococcal disease in children. The impact of the vaccine was noted within 1 year of     introduction. According to Centre for Disease Control's (CDC) Active Bacterial Core     Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years     dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80     to 4.6 per 100,000. Currently there are two immunization schedules: manufacturer recommended     the 3+1 schedule and many countries adopted a 3 dose schedule, either 3+0 or 2+1 schedules.     In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month) plus     one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that two     doses may provide similar direct protection to three conjugate doses during infancy, it is     recommended to give two doses during infancy plus a booster dose 12 months in some European     countries including United Kingdom.      In this trial, the immunogenicity of the 3+1 schedule and the 2+1 schedule of 7-valent     pneumococcal conjugated vaccine in young infants will be compared.   "
95172|NCT02040389|"     The aim of this study is checking impact of visual guidelines (picture book) and tutoring in     pediatric urologic surgery   "
95173|NCT02040376|"     A placebo controlled double blind crossover trial of metformin in 30 children treated with     radiation for medulloblastoma - the most common malignant brain tumour. The investigators     will use tests of thinking and learning and brain imaging techniques to examine whether     metformin can enhance cognition or promote brain repair following radiation-induced brain     injury.   "
95174|NCT02040363|"     COPD patients experiment a peripheral muscle dysfunction which impact their exercise     tolerance and health-related quality of life. The capillary to fiber interface is reduced and     impact the exercise capacity of the patients. While exercise training induce a physiological     angiogenesis, we have recently observed that there was a blunted muscle angiogenesis after     training in COPD patients. This could be the consequence a an inadequate training duration or     intensity. Aim of the study: Compare the muscle micro-vascular response to training     (capillary-to-fiber ratio) at 5 and 10 weeks, in sedentary healthy subject trained at the     intensity of the ventilatory threshold (60-65% of VO2max), versus :- COPD patients trained at     a similar intensity (60-65% of VO2max)- COPD patients trained at a similar absolute intensity     (90% of VO2max).   "
95175|NCT02040350|"     To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide     poisoning (Organophosphorous poisonings)   "
95176|NCT02040337|"     The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire     differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy     controls.   "
95177|NCT02040324|"     We measure in this study lung function of 100 patients immediately after major lower     abdominal surgery. We compare lung function, when either endotracheal intubation, or     laryngeal masks are used for airway protection during surgery. The hypothesis is that the use     of laryngeal masks is associated with less impairment of lung function in the immediate     postoperative phase.   "
95178|NCT02040311|"     The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192     mg daily) as compared to placebo in maintaining weight loss in obese subjects who     participated in an eight week intensive non-pharmacologic weight loss program.      The primary efficacy endpoint will be the percent change in body weight from enrollment visit     to week 60.   "
95179|NCT02040298|"     The main purpose of this study is to assess clemastine as a remyelinating agent in patients     with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of     clemastine, originally approved as first-generation antihistamine, in patients with multiple     sclerosis. Study procedures will include assessments for evidence of remyelination in the     anterior visual pathway and in the brain using electrophysiologic techniques and magnetic     resonance imaging. The study will also assess the robustness and stability of this clinical     effect in patients taking clemastine for up to 3 months. Patients in this study can remain on     their standard disease modifying treatment during the course of the study. However, patients     cannot participate in any other investigational new drug research study concurrently.   "
95180|NCT02040285|"     The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography     Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient     tolerability and acceptance.   "
95276|NCT02039037|"     Chronic nonspecific low back pain is a major health and socioeconomic responsible for a high     rate of employee absenteeism and reduced functional performance. The use of acupuncture as an     alternative therapy in the treatment of low back pain and electroacupuncture to enhance the     treatment has been effective; however, there is little evidence of the effectiveness of one     over the other.   "
95181|NCT02040272|"     Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2300     people in the UK are diagnosed with mesothelioma each year and the average survival is     approximately 17 months. Exposure to asbestos is the most common cause although the cancer     does not usually become apparent until 30-40 years after exposure. Anti-cancer drugs     (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing     surgery (pleurectomy decortication) surgery is undertaken. However, it is not known if this     surgery, in addition to chemotherapy, can increase survival and improve the quality of life     for patients. The aim of the MARS2 study is to determine if it is feasible to enrol patients     with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and     lung-sparing surgery. Patients will be followed up regularly at their usual clinic visits for     to 5 years. Patients will be asked to complete a Quality of Life Questionnaire at these     visits. Tissue samples will be taken at the time of diagnosis and at surgery (if they are     randomised to surgery) for mesothelioma research central storage and blood samples will be     taken at the clinic visits up to 12 months for mesothelioma research central storage. If we     can show the feasibility of recruitment we will apply to continue the study to include more     patients in order to determine if lung-sparing surgery improves survival and quality of life     for mesothelioma patients.   "
95182|NCT02040259|"     The purpose of the Trevo® Retriever Registry is to collect real world performance data of the     Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing     thrombus in patients experiencing ischemic stroke.   "
95183|NCT02040246|"     The prevalence of diabetes is up to 11.6% according to the data released in 2013 by the China     Noncommunicable Disease Surveillance Group.Less than 40% of all diagnosed-diabetes were well     controlled.Among all kinds of antidiabetic medications, metformin is recommended as the     first-line antihyperglycemic management for type 2 diabetes. Insulin secretagogue,repaglinide     is still one of the most widely used antidiabetic medications in China. However, there were     few studies comparing the effects of these two medications on glycaemic control in Chinese     patients with type 2 diabetes.   "
95184|NCT02040233|"     This is a study to investigate the safety, tolerability and early effects on cardiac function     of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will     be applied once daily over 7 days in addition to standard therapy including a beta-blocker.     The aim of the study is to assess if a 7 day treatment with BAY1067197 is well tolerated when     given on top of standard therapy for heart failure. Furthermore, the study aims to assess if     cardiac function improves in the early course of therapy.   "
95185|NCT02040220|"     This is a prospective, non-interventional, multi center post-authorization safety study that     includes patients with a diagnosis of CRVO. The investigator will have made the choice of     treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert     prior to enrolling the patient in this study.      The observation period for each patient starts when therapy with EYLEA is initiated. The     enrollment period is 2 years. Patients will be followed for a time period of 2 years or until     it is no longer possible (e.g. lost to follow-up) within the 2 years.      For each patient, data are collected as defined in the case report form at the initial visit,     follow-up visits and final visit, either by routine clinical visits (as per investigators     routine practice).      There will interim analysis of study data: 6 months after last patient first visit and     J-PSUR(Japanese-Periodic Safety Update Report )   "
95186|NCT02040207|"     The purpose of this research study is to test the safety and local tolerance of repeated     treatment with AM-101.   "
95187|NCT02040194|"     The purpose of this research study is to test the safety and effectiveness of the study drug,     AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an     injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with     tinnitus can take part in the study, if their tinnitus started within the last 3 months or     within the last >3 to 6 months.   "
95188|NCT02040181|"     It's important to dose according to renal function in who has impaired kidney function. There     are two common methods estimating renal function: one is creatinine clearance estimated by     Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by     Modification of Diet in Renal Disease (MDRD) equation.      The previous study (not published) showed that CG underestimated 24 hour measured urine     creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to     establish a estimated creatinine clearance equation fitting in Taiwanese.      Besides, there are lots of studies discussing difference between CG and MDRD. We have found     that MDRD overestimated CG in patients who were older or thin. Therefore, we want to analysis     which characteristics of patients the difference are largest or smallest.   "
95207|NCT02039934|"     High intensity interval training is applied for several diseases.      Hypothesis: High intensity interval training improves insulin sensitivity in patients with     type 2 diabetes.   "
95208|NCT02039921|"     The study aims to describe the changes of combination antiretroviral therapy and the causes     that motivated them.   "
95243|NCT02039466|"     Postoperative pulmonary complications following abdominal surgery are frequent and associated     with increased morbidity and mortality and hospital length of stay. Pressure controlled     ventilation will improve oxygenation indices , hemodynamics during anesthesia for     laparoscopic colectomy, decreasing postoperative pulmonary complications.   "
95189|NCT02040168|"     Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU).     Its use requires almost always the establishment of a sedation. Sedation is a generic term     for all procedures, pharmacological or not, ensuring physical and psychological comfort and     the safety of patient admitted in intensive care units.      An inadequate sedation, insufficient or excessive, has common side effects, as increase of     the duration of mechanical ventilation and of hospital-acquired infections (in particular,     ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or     accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD).     All these complications increase mechanical ventilation time and ICU length of stay. Several     studies in adult's population have shown that the implementation of a sedation algorithm     allowed to decrease the incidence of these complications.      We hypothetized that the duration of mechanical ventilation would be reduced by a     nurse-implemented sedative management protocol.   "
95191|NCT02040142|"     This is a clinical study investigating the new treatment of surgery combined with     intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the     peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved     by the U.S. Food and Drug Administration (FDA)for many different cancers including     gastrointestinal cancer. Giving mitomycin C via the intraperitoneal route is not FDA approved     and is an investigation therapy. Cytoreductive surgery plus intraperitoneal chemotherapy can     be offered as standard of care outside of a clinical trial. However, since this is an     unproven and potentially more effective but a more toxic approach, the investigators are     performing this procedure under an IRB approved clinical trial in order to better evaluate     the risks and benefits of this approach.      A standardized, evidence-based approach is currently lacking for patients with peritoneal     surface malignancy from gastrointestinal origin. A clinical trial with surgical quality     assurance and modern hyperthermic intraperitoneal chemotherapy incorporating critical     assessment of disease burden, determinants of complete cytoreduction, treatment-related     toxicity, quality of life and survival is imperative. Theoretically, cytoreductive surgery is     performed to treat macroscopic disease, and hyperthermic intraperitoneal chemotherapy is used     to treat microscopic residual disease with the objective of removing disease completely in a     single procedure.   "
95192|NCT02040129|"     This study was conducted to evaluate changes of reduction of corneal astigmatism with toric     intraocular lens(IOL) in congenital cataract.   "
95193|NCT02040116|"     The purpose of this study is to evaluate the impact of rapid infusion rituximab on the     incidence of infusion-related reactions in patients with Autoimmune Diseases.   "
95194|NCT02040103|"     Patients admitted to the intensive care unit are at high risk of developing clots in the     veins of the lower extremities. The objective of this study is to examine whether the use of     a device that provides intermittent compression to the legs in addition to the use of     low-dose blood thinners, provides an additional protection when compared to the use of blood     thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose     blood thinners to prevent clots are candidates for this study. Patients who are enrolled will     continue to receive blood thinners but some will additionally receive the leg compression.     The additional use of leg compression may provide protection from clots. The main side effect     is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah     International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and     Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada,     Australia, Brazil and possibly other countries. The study started July 2014 and is to     continue for 4 years.   "
95195|NCT02040090|"     The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in     comparison with HRIG comparator product. 2. To assess whether KamRAB interferes with the     development of self active antibodies when given simultaneously with active rabies vaccine,     as compared to the HRIG comparator product, also given in conjunction with the active rabies     vaccine.   "
95196|NCT02040077|"     Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in     the general population. Fatal OD from opioid analgesics specifically has increased over 400%     between 1999 and 2008, and nonfatal overdose occurs at a rate 3-7 greater than fatal OD.     Unintentional opioid OD is a public health crisis in several societal populations including     drug users, patients being treated for chronic pain, elderly individuals, adolescents, and     children. Educational interventions have been developed to increase knowledge regarding     opioid OD risk factors, symptoms, and appropriate responses, however no randomized controlled     evaluations of these interventions have been conducted. Within-subject evaluations report     immediate and sustained increases in participant knowledge and behavior change, yet these     programs suffer from limitations that may limit their widespread dissemination. Thus, there     is an urgent, critical need to develop an opioid OD educational intervention that can be     accessed by a broad audience, and produces immediate and sustained gains in knowledge in an     easily administered and cost-effective way. This study will develop a web-based,     computerized, interactive, opioid OD education training program that will incorporate     multi-media learning components and fluency training to produce knowledge gains. This program     will be evaluated using a randomized, controlled comparison of the active intervention     against two control interventions. Participants will be recruited from a brief inpatient     detoxification (n=75), will receive the intervention immediately upon completing the     detoxification (post-treatment), and will complete 2 follow-up visits to evaluate sustained     knowledge. The primary outcome will be percent change from baseline on a knowledge test that     is administered immediately before and after the intervention, and at a 1 and 3-month     follow-up visit. Secondary outcomes will include self-reported behavior change and     participant acceptance of the intervention. The study hypothesis is that participants who     receive the primary intervention will evidence the largest increase in knowledge gain and     retention over time, compared to the control groups. The rationale and public health benefit     of this research cannot be understated- this project will make available a brief,     empirically-supported intervention that can be administered quickly and easily within     hundreds of settings (e.g., treatment centers, prisons and jails, needle exchange centers,     primary care offices, schools), and to diverse patient populations (e.g., drug users, chronic     pain patients, elderly, student, children, parents). These outcomes are expected to have a     positive impact because they will provide cheap, easily-administered intervention strategy     that will help reduce the current national epidemic of opioid OD, and will expand the use of     computerized interventions to address public health issues more broadly.   "
95215|NCT02039830|"     The recommended treatment for urinary incontinence (UI) in women is individualised pelvic     floor muscle (PFM) training, a costly and resource-intense approach; one Canada is currently     unable to meet. This non-inferiority randomized control trial seeks to determine if     group-based PFM training is as effective as individualised PFM training for treating UI in     women 65 and over, and to establish the cost-effectiveness of both. Demonstrating that     group-based treatment is at least as good as individualised one-on-one treatment and more     cost-effective would warrant including group-based PFM training as a first-line UI treatment.   "
95209|NCT02039908|"     Although stimulant medication is a well-established treatment for ADHD, it is often necessary     for doctors to increase the dose over time to maintain the benefits of the medication. While     medication can be very effective for improving symptoms of ADHD during the first year of use,     it has not been found to significantly improve the long term course of children with ADHD.     For example, in large research studies, groups of children who take medication for ten years     do not have consistently better academic grades than groups of children who never used     medication (individual results will vary from child to child).      In order to help children with ADHD achieve the best possible outcomes, it is important for     doctors to study why this happens. One possible reason is development of tolerance to the     medication. Tolerance means that a drug's effects decrease when it is taken consistently over     time, so that an increased dose is needed to continue showing effects. Some doctors believe     that children who take stimulant medication for ADHD develop tolerance to it which would     explain why benefits may not persist over time, but no research studies have been done to     measure whether this occurs. This study aims to see if children show a tolerance effect to     stimulant medication and whether that tolerance can be prevented by taking short breaks from     the medication called medication holidays.   "
95197|NCT02040064|"     This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib     and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an     activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as     Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety and     tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and to     establish a recommended phase 2 dose. Secondary objectives include evaluation of,     pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab     combination. The exploratory objectives are to evaluate biomarkers that may correlate with     activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib.      The biological rationale for such a study is that even though the disease is progressing it     is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR     TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can     potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation     of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today     no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover,     patients may have received chemotherapy and the likelihood of chemosensitivity is very low.     So, the association of Gefitinib with immune checkpoint blockade is very attractive and may     result in clinical benefit in NSCLC with EGFRmut.   "
95198|NCT02040051|"     The purpose of this study is to assess the effect of sound insulation and music therapy on     the comfort of mechanically ventilated patients admitted to intensive care unit measured by     the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)   "
95199|NCT02040038|"     The purpose of this study is to determine whether participation in virtual environment which     incorporates real-time diabetes self management and support (DSMT/S) is associated with     positive changes in behavior and metabolic outcomes as compared to traditional web-based     DSMT/S.   "
95200|NCT02040025|"     The purpose of this proposed Department of Defense study is to evaluate the effect of     Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood     pressure of type 2 diabetic patients receiving EECP therapy.   "
95201|NCT02040012|"     Objectives:      Primary Objectives        -  To investigate the safety and tolerability of single ascending doses of AZP- 531 in          healthy volunteers.        -  To investigate the safety and tolerability of single and multiple ascending doses of          AZP-531 in overweight/obese volunteers.        -  To investigate the safety and tolerability of single and multiple ascending doses of          AZP-531 in patients with type 2 diabetes mellitus.      Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after     single and multiple doses.      Exploratory Objectives      • To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of     blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated     ghrelin (UAG)   "
95202|NCT02039999|"     Despite its commonplace use in respiratory medicine the mechanism whereby inhalation     challenge with a variety of mild acid aerosols produces a dose related and predictable cough     is unknown. In this proposal the investigators wish to use established cough challenge     methodology to explore the mechanism of action of agents provoking cough both in health and     disease.      The hypotheses to be tested include:        -  Intracellular changes in pH, rather than extracellular changes, are key in the          activation of TRP receptors, the main sensor for provoking cough.        -  ATP acting through P2X channels is the mechanism of increased nerve excitability          underlying cough hypersensitivity.   "
95203|NCT02039986|"     This study is aimed at better understanding the impact of ivacaftor upon insulin and incretin     secretion and glucose tolerance in patients with Cystic Fibrosis with a glycine (G551D)     mutation. Investigators hypothesize that treatment with ivacaftor improves insulin secretion     in individuals with CF.   "
95204|NCT02039973|"     Although there is a significant burden of depression among HIV-positive women in Tanzania,     there is a critical gap between the needs of this population and the integration of mental     health and PMTCT-plus services. The long-term intent of the research is to bridge this gap     with the overall goal to examine the potential for successful integration of enhanced mental     health care and brief group interventions among HIV-positive women receiving PMTCT-plus     services and to evaluate a combination of evidence-based approaches for treatment of     depression in this vulnerable population in Tanzania.   "
95205|NCT02039960|"     Bupropion hydrochloride was first approved on 30 December 1985 in United States for     depression and is currently approved in 80 countries. Bupropion has also subsequently been     approved for smoking cessation and for seasonal affective disorder.      Cumulative exposure to bupropion is estimated at approximately 97.3 million patient exposures     up to 31 December 2012.      Bupropion hydrochloride is a weak catecholamine reuptake inhibitor predominantly affecting     serotonin, norepinephrine and dopamine. Its mechanism of action and its structural     similarities to diethylpropion, amphetamines, and cocaine, bupropion resembles stimulants in     many respects, leading to concerns about potential abuse of the product.      Abuse potential had been part of the Benefit Risk Management Plan for bupropion up until 2003     and at that point, had no longer been regarded as a potential risk that required     additional/further evaluation outside standard pharmacovigilance monitoring. The current     European Risk Management Plan also states that standard pharmacovigilance monitoring applies     to abuse potential. Monitoring has shown a recent increase in the number of spontaneous     reports from the Adverse Event reporting System (AERS) of drug abuse.      The bupropion team agreed that although the numbers of abuse reports was small relative to     the total number of reports for bupropion in OCEANS, there was sufficient information in AERS     to warrant investigation of the potential effect on public health.      To investigate the degree of misuse and abuse of bupropion (including non-oral routes of     administration) in the United States, the Drug Abuse Warning Network will be used to examine     the study period 2004-2011.   "
95218|NCT02039791|"     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck     (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phaseⅡtrial     is designed to assess the resection rate and pathological complete response of nimotuzumab     plus carboplatin and paclitaxel in patients with cervical cancer.   "
95210|NCT02039895|"     Radiation therapy, Total skin electron beam therapy (TSEBT), achieves a high response rate     and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial region.     One the most widely used TSEBT techniques consists of six dual fields initially developed at     Stanford University. However, deviations occur from the prescription dose up to 40% and the     surface dose inhomogeneity as much as 90% in body areas such as the perineum and eyelid.      Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length     of up to 160 cm, continuously in a helical pattern without the need for field junction. Using     HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSEBT technique     to increase dose delivery and decrease toxicities possibly. Recently, we published the     possibility of helical irradiation of the total skin (HITS) by physical proving and showed     the clinical results of HITS successfully for a woman with T cell lymphoma failure by     chemotherapy, topic UV irradiation and local radiotherapy (RT) to overcome the surface dose     inhomogeneity by conventional RT.      Here, investigators will enroll the stage I-IV cutaneous T-cell lymphoma (CTCL) of     International Society Cutaneous Lymphomas (ISCL)/U.S. Cutaneous Lymphoma Consortium     (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are     candidates for TSEBT by recommendation of National Comprehensive Cancer Network Guidelines     (Version 4.2011, Mycosis fungoid/Sezary syndrome) or who are refractory or not feasible to     the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy,     and Accutane® (Isotretinoin) or chemotherapy to receive HITS to replace TSEBT. Additionally,     we will compare the advantages and disadvantages between the plan of HT and conventional RT     for TSEBT.   "
95211|NCT02039882|"     Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by     significant coronary artery disease on cardiac catheterization/revascularization or     reversible defect seen on stress test. Each year approximately 8-10 million patients undergo     an emergency department evaluation for possible acute coronary syndrome (ACS) in the United     States Up to 8%of patients who have myocardial infarction (MI) are inadvertently discharged.     Unnecessary admissions for presumed myocardial disease result in health care costs that are     estimated to exceed 5 billion dollars annually Currently, the cardiac biomarkers troponin and     Creatine phosphokinase (CPK-MB), in conjunction with ECG changes are used to evaluate a     patient routinely for ACS. However, these tests have limitations for identifying most     patients who have ACS in a rapid fashion. Purine molecules such as inosine and hypoxanthine     and have been shown to also be biomarkers of acute MI. High pressure liquid chromatography     (HPLC) is the traditional method of analysis of these purines. The HPLC method however     requires hours to assess biomarkers, as do the more traditionally used troponin and CK-MB     methods.      Recently, the investigator has developed a rapid chemo luminescence method for detecting     purine biomarkers. This modality can provide an expeditious (requires less than 4 minutes to     complete analysis), bedside method of analysis for ACS through routinely acquired blood     samples. In this study the investigator will compare the results of the chemo luminescence     method with the gold standard HPLC method, and results of the traditional cardiac markers     troponin and Creatine phosphokinase (CK-MB) in patients undergoing an evaluation for ACS.     Details of noninvasive and invasive cardiac assessments performed as part of the routine     evaluation by the clinician for myocardial assessment and intervention in conjunction with     biomarker assessment will be obtained. The investigator hypothesize that the rapid chemo     luminescence biomarker assessment will identify patients with ACS faster than traditional     diagnostic methods.      The goal of this study is to assess the role of rapid assessment of purine biomarkers in     identifying patients who may have ACS.   "
95212|NCT02039869|"     The purpose of this study is to find out if people who have non-erosive reflux disease (NERD)     have changes the investigators can see with a microscope (called confocal endomicroscopy)     that is used during endoscopy (a camera scope evaluation of the inside of your stomach and     swallowing tube). Traditionally the investigators have used trials of acid blocking     medications (PPIs), endoscopy and measurements of acid in the swallowing tube (the esophagus)     to determine if the investigators think acid is causing troublesome symptoms. The medical     community believes that these symptoms are due to increased spaces between the cells that     make up the swallowing tube. The investigators can directly see those spaces with a new     microscope that the investigators can pass through the camera scope.      Participants will be assigned to take one of two medications omeprazole and sucralfate (both     approved medications for stomach symptoms) to treat their symptoms and record how well the     treatment works. The investigators then will look to see if the microscope can predict which     medication will work best for patients in the future. The investigators also plan to measure     the acid levels in your swallowing tube and do a camera evaluation of your swallowing tube     and stomach as this is standard for patients with your symptoms. The investigators will     compare the results of those studies to the microscope findings.   "
95213|NCT02039856|"     VA has undertaken a major initiative to transform care through implementation of Patient     Aligned Care Teams (PACTs). Based on the patient-centered medical home (PCMH) concept, PACT     aims to improve access, continuity, coordination and comprehensiveness using team-based care     that is patient-driven and patient-centered. However, how VA should adapt PACT to meet the     needs of special populations, such as women Veterans, is yet to be worked out. The main goal     of this study is to develop and test an evidence-based quality improvement (EBQI) approach to     adapting and implementing PACT for women Veterans, incorporating comprehensive women's health     care in gender-sensitive care environments, thereby accelerating achievement of PACT tenets     for women Veterans and reducing persistent gender disparities in VA quality of care.   "
95214|NCT02039843|"     Service Dogs are trained to assist people with disabilities to accomplish tasks which permit     the individual to be more functional in their home and social environment. Often the dogs are     trained to help in the completion of activities of daily living and instrumental activities     of daily living. Service Dogs are efficacious for individuals with disabilities, such as     vision limitations, spinal cord injury and hearing problems. In addition, some mental health     outcomes have improved with the introduction of a Service Dog. A research study was mandated     in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for     Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies     Program, the proponents have designed a research study to effectively meet the demands of the     Bill and to provide timely research into an evolving field.   "
95217|NCT02039804|"     Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve     pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient     clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter     major, overlying the lateral aspect of the hip. When pain is persistent after conventional     therapies, anesthetic and corticosteroid (CS) injections can provide short term to     intermediate relief of pain, but relapse is common. Only one retrospective study showed the     efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain     release is significant with large effect sizes for both treatment. However, the efficacy of     CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is     significant compared to CS (p<0.05).      In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the     treatment of trochanteric bursitis.   "
95337|NCT02038244|"     In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for     integrative medicine on pain, disability, quality of life, satisfaction with life,     depression, and anxiety will be investigated. Furthermore the influence of potential process     variables will be evaluated.      Effects will be measured after completion of the program (2 weeks), and at 6 months follow up     after start of the program.   "
95219|NCT02039778|"     There are preliminary studies that suggest that radiation therapy to areas of the brain     containing cancer stem cells (in addition to the area where the tumor was surgically treated)     may help patients with high-grade brain tumors live longer. The purpose of this study is to     determine whether the addition of stem-cell radiation therapy to the standard chemoradiation     will further improve the outcome. The investigators will collect information about the     patient's clinical status, disease control, neurocognitive effects, and quality of life     during follow-up in our department.      The purpose of the study is to improve the overall survival patients with newly diagnosed     malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The     investigators will also measure how patients treated with this novel method of radiation     therapy do over time in terms of disease control, potential neurocognitive side effects,     overall function, and quality of life.   "
95220|NCT02039765|"     To characterize the plasma pharmacokinetics and safety profile of brimonidine following a     single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution     0.025% for 7 days in healthy, adult subjects.   "
95221|NCT02039752|"     The purpose of this study is to evaluate long-term prognoses of patients with multivessel     coronary disease treated medically or surgically or percutaneously in real world practice.   "
95222|NCT02039739|"     The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting     Stent in Routine Clinical Practice   "
95223|NCT02039726|"     The primary objective of the study is to determine whether quizartinib monotherapy prolongs     overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine     kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have     relapsed within 6 months, after first-line AML therapy.   "
95224|NCT02039713|"     The purpose of this study is to evaluate effectiveness and safety of DESyne in Routine     Clinical Practice   "
95225|NCT02039700|"     This study will assess the absolute bioavailability of a single oral dose of lesinurad and     evaluate the pharmacokinetic (PK) parameters of lesinurad and [14C]lesinurad in healthy adult     male subjects.   "
95226|NCT02039687|"     The purpose of this study is to determine whether ARA 290, a new class of compound, is     effective in the treatment of the neuropathic symptoms of sarcoidosis. Brief interaction of     ARA 290 with the innate repair receptor results in anti-apoptotic and anti-inflammatory     activities in myriad of cells, tissues and organs throughout the body to activate repair     mechanisms and accelerate healing, including the nerve damage that can be associated with     sarcoidosis. In this study, subjects with sarcoidosis and symptoms of small fiber neuropathy     will administered ARA 290 or placebo by subcutaneous injection daily for 28 days. In addition     to monitoring the safety of the treatment, the symptoms of the subjects will be assessed with     several questionnaires, function tests, and measurement of nerve fibers in their cornea and     skin (via a non-invasive test and a biopsy, respectively). The total participation time for     each patient will be 16 weeks.   "
95227|NCT02039674|"     The purpose of this study is to determine safety, tolerability, and efficacy of pembrolizumab     (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable     or metastatic non-small cell lung cancer (NSCLC   "
95228|NCT02039661|"     The effect of lidocaine spray on pain relief during endometrial sampling.   "
95229|NCT02039648|"     Periodontitis is a biofilm depended oral infection. It leads to inflammatory destruction of     periodontal tissues and if left untreated to tooth loss. Porphyromonas gingivalis (P.g.) is     one of the major pathogens associated with the onset and progression of periodontitis.     Previous in vitro studies have shown that a proanthocyanidin-enriched extract from Rumex     acetosa L. inhibits the adhesion of P.g. and acts in a cytoprotective manner. Since the the     bacterial adhesion to oral mucosa cells is a pivotal step for the P.g. mediated tissue     destruction, its inhibition may be helpful in preventing the colonization with P.g. or its     eradication in P.g. infected patients. Therefore, the aim of this controlled, randomized and     double blinded study was to analyze the effects of a Proanthocyanidin-enriched extract from     Rumex acetosa L. on the intraoral colonization with Porphyromonas gingivalis in individuals     harboring P.g. intramurally.   "
95230|NCT02039635|"     Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean     Red Ginseng is effective compared with a placebo in chemotherapy.      The purpose of this study is to determine whether Korean Red Ginseng is effective in the     treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)   "
95231|NCT02039622|"     The study is multicenter, post-authorization, observational and ambispective   "
95263|NCT02039206|"     To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar     deficits in patients with SCA3 and to establish its safety in this population.      Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may     induce significantly therapeutic effects in patients with SCA3 and will pave the way for     establishing a novel and effective treatment for this disorder.   "
95232|NCT02039609|"     In the post-genomic era, a major challenge for health research is to understand the complex     interactions among genetic, environmental and lifestyle factors including dietary intake.     Unfortunately, such initiatives are hampered by the lack of accurate dietary intake     assessment methods for large studies. The newly emerging field of metabolomics offers unique     possibilities to characterize individual food intake, dietary patterns and effects of dietary     intervention in large studies. The investigators propose to develop a platform to detect     broad metabolomic responses to food intake in controlled trials as well as to use targeted     metabolomics approaches to characterize dietary intake in longitudinal studies. Our     laboratory has a long history of developing methodology for assessing nutritional status and     effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy     Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern     metabolomics equipment and competence in bioinformatics, and use this in the context of     nutrition research. To their knowledge, the investigators are among the first groups in the     country to develop skills in metabolomics to assess dietary intake and effects of nutrition     on metabolism, and probably the first to use two complementary platforms with both     mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should     be useful to nutritional scientists nationally as well as internationally.   "
95233|NCT02039596|"     In the post-genomic era, a major challenge for health research is to understand the complex     interactions among genetic, environmental and lifestyle factors including dietary intake.     Unfortunately, such initiatives are hampered by the lack of accurate dietary intake     assessment methods for large studies. The newly emerging field of metabolomics offers unique     possibilities to characterize individual food intake, dietary patterns and effects of dietary     intervention in large studies. The investigators propose to develop a platform to detect     broad metabolomic responses to food intake in controlled trials as well as to use targeted     metabolomics approaches to characterize dietary intake in longitudinal studies. Our     laboratory has a long history of developing methodology for assessing nutritional status and     effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy     Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern     metabolomics equipment and competence in bioinformatics, and use this in the context of     nutrition research. To their knowledge, the investigators are among the first groups in the     country to develop skills in metabolomics to assess dietary intake and effects of nutrition     on metabolism, and probably the first to use two complementary platforms with both     mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should     be useful to nutritional scientists nationally as well as internationally.   "
95234|NCT02039583|"     The purpose of this study is to investigate whether there has been a change in low birth     weight and perinatal and infant mortality following the July 2007 introduction of a ban on     smoking in public places and workplaces in England.   "
95235|NCT02039570|"     This case series aims to find out in a group of female patients suffering from haemorrhoids,     how many of them have pelvic vein reflux that feeds into their haemorrhoids.      This will be done by examining their ovarian and internal iliac veins for reflux, using a     transvaginal scan.   "
95236|NCT02039557|"     This is an observational study that will monitor patient's clinical outcomes. A patient can     enroll in the NiCord® Long Term Follow Up Protocol only after the informed consent has been     signed, and he/she has completed the study specific follow-up.   "
95237|NCT02039544|"     A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi     Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi     Deficiency and Blood Stasis)   "
95238|NCT02039531|"     HYPOTHESIS:      The application of plasma rich in growth factors (PRGF) will improve the quality of life and     functional capacity of patients diagnosed with knee osteoarthritis, providing better     functional results than conventional treatment with viscosupplementation.      OPERATING ASSUMPTIONS      Following the initial administration of three doses of PRGF interspersed every 15 days,     applied via intraarticular, patients will present an improvement in functional test (WOMAC     and Lequesne scales) of 15% or more after 6 and 12 months compared to the control group with     patients treated with hyaluronic acid.   "
95239|NCT02039518|"     The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine     Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined     With Platinum Based First-line Chemotherapy   "
95240|NCT02039505|"     This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,     parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002     (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or     severely active ulcerative colitis.   "
95241|NCT02039492|"     Background: In hypertension, a highly prevalent disease, up to 10-15% of hypertensive     patients have uncontrolled blood pressure despite a regimen of ≥ 3 drugs, which is known as     resistant hypertension (RH). Cardiovascular prognosis in patients with RH is worse than in     controlled hypertensives. Efferent renal sympathetic nerves play an important role in volume     homeostasis and blood pressure. A novel minimally invasive technique based on the use of     selective radiofrequency renal sympathetic denervation has shown promising preliminary     results for the treatment of these patients. On the other hand, some patients with RH could     improve their blood pressure control by adding spironolactone, an antagonist of aldosterone     receptors.      Objective: To evaluate the efficacy of radiofrequency renal sympathetic denervation in     patients with RH, as compared with the addition of spironolactone to the therapeutic regimen     at baseline.      Method: interventional, prospective, randomized, open study, of a cohort of 50 patients with     RH, with office systolic blood pressure ≥ 150 mmHg and also with 24h systolic blood pressure     ≥ 140 mmHg, despite treatment with ≥ 3 drugs in adequate doses, one of them a diuretic, and     whitout treatment with either spironolactone or eplerenone. Patients will be randomized (1:1)     to renal sympathetic denervation treatment or spironolactone (50mg), performing determination     of office blood pressure and 24h-ABPM at pre-randomization, 1, 3 and 6 months, as well as     laboratory tests, echocardiography, measurement of carotid intima-media thickness and central     blood pressure measurement at pre-randomization and after 6 months.   "
95661|NCT02034006|"     The primary objective of the study is to investigate current criteria driving re-treatment in     patients affected by CNV secondary to PM and experiencing a relapse of the disease after the     first administration of ranibizumab.   "
95244|NCT02039453|"     During sedative colonoscopy, use of propofol have been increased world wide. The onset time     of propofol is shorter than midazolam. However the most popular additive pain killer,     pethidine show different pharmacodynamic feature. The pethidine has longer onset time than     propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of     fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl     was not studied. Therefore, we designed this study to compare both drug to check satisfaction     of this drug.   "
95245|NCT02039440|"     The purpose of this study is to determine whether there are persisting antibodies against     Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or     confirm mathematical models accordingly.   "
95277|NCT02039024|"     The primary objective of this protocol is to investigate the monoaminergic     (dopamine、serotonin、and norepinephrine ) nervous system and amyloid deposition in Parkinson's     disease patients with non-motor symptoms (focus on impulse control disorders and dementia) by     novel 18F-DTBZ and Florbetapir F-18 PET imaging.      This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and     monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group.      Investigators will also analyze monoaminergic function by18F- DTBZ PET in PDI group.   "
95246|NCT02039427|"     Sore throat is one of most frequent complaints related to general anesthesia with tracheal     intubation. Although sore throat is regarded as a minor and short-lasting discomfort after     surgery, its incidence and intensity in high risk patients such as female gender, head and     neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative     recovery and give patient dissatisfaction.      Even though the pathophysiology of post-intubation airway symptoms is not completely     clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has     been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly     used strategy to prevent postoperative airway discomfort after intubation. The preoperative     administration of dexamethasone has been reported to reduce the incidence and severity of     postoperative sore throat, but it is accompanied with the adverse effects such as     hyperglycemia, delayed wound healing and increased infection in surgical patients. Ketorolac,     non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used for     postoperative pain control and has anti-inflammatory effect.      Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in     comparison to dexamethasone after thyroidectomy in female adult patients   "
95247|NCT02039414|"     Regular maternal physical activity leads to the delivery of lighter, leaner infants. Higher     birth weights and childhood obesity are both strong predictors for adult obesity, suggesting     that the impact of maternal physical activity on the future health of a child is substantial.     However, the mechanisms underlying the relationships between maternal physical activity and     improved infant outcomes are unclear. Thus, the purpose of this project is to measure two     potential contributing factors: maternal fat metabolism and maternal oxidative stress     profiles. The investigators believe that maternal physical activity leads to beneficial     alterations in maternal fat metabolism and oxidative stress profiles. Further, the     investigators believe that both maternal fat metabolism and oxidative stress levels are     related to infant outcomes such as obesity and insulin resistance. Therefore, exercise will     improve maternal metabolic factors that can lead to improvements in infant outcomes. The     investigators will compare these factors between obese inactive pregnant women and obese     active pregnant women. This study design will allow us not only to determine the effect of     physical activity on maternal and neonatal pregnancy outcomes, but also to establish whether     obesity or physical inactivity should be a primary area of focus when prescribing pregnancy     interventions in clinical practice.   "
95248|NCT02039401|"     The purpose of this study is to determine the safety and tolerability of intramuscular     injections of VM202 at different injection sites in people with amyotrophic lateral     sclerosis.   "
95249|NCT02039388|"     The current study aims at answering the scientific question, whether exfoliated cells from     STICs get transported into the uterine cavity via the fallopian tube, and whether it is     possible to detect those cells in the lavage fluid from the uterine cavity and proximal     fallopian tubes.      To address this question, the investigators will study 20 lavage samples and their 20     corresponding STIC-positive tissue samples in women who opt for risk-reducing bilateral     salpingo-oophorectomy (rrBSO) because of increased risk of high grade serous carcinoma of the     pelvis (HGSC) (mostly carrying a BRCA mutation), without a history of tubal occlusion for     sterilization. Women who opt to have the fallopian tubes removed but the ovaries preserved     are eligible for the study too, as are women who opt for rrBSO plus hysterectomy.   "
95250|NCT02039375|"     Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for     treatment of acute ischemic stroke. In the United States, IV tPA is typically administered in     the Emergency Department (ED) for patients presenting with acute ischemic stroke within 4.5     hours of symptom onset. It is current practice that post-tPA patients are monitored in an     intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in part     due to frequent vital sign and neurological monitoring that is currently the standard of     care. However, rigorous evidence to support this practice is largely lacking. In a     retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and     Johns Hopkins Bayview Medical Center (JHBMC), we have shown that most patients who have ICU     needs in the first 24 hours after tPA administration develop such needs by the end of the tPA     infusion. Patients without ICU needs by the end of the tPA infusion, do not require further     ICU resources if their presenting NIH Stroke Scale (NIHSS) is below 10. This study is a     prospective clinical trial that aims at establishing the first proof-of-concept and     feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and that do not need ICU     care by the end of the tPA infusion, can be monitored safely in a non-ICU setting with a     novel monitoring protocol. Identifying post-tPA patients who can be safely monitored in a     non-ICU environment may improve cost-effective utilization of ICU resources and reduce the     length of hospitalization for stroke patients.   "
95251|NCT02039362|"     The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around     30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using     tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from     Western countries are needed.   "
95345|NCT02038140|"     The primary objective of this study is to obtain implant survivorship and clinical outcome     data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary     or revision total ankle arthroplasty. The assessment will include implant survivorship and     clinical performance measured by pain and function, quality of life data, radiographic     parameters and survivorship.   "
97064|NCT02015702|"     This study was intended to test the effects of adding a one-on-one educational intervention     taught by a physician to a physician during their clinical work to improve their acceptance     and satisfaction with a new inpatient electronic health record and ordering system.   "
95275|NCT02039050|"     In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or     blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the     airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic     antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a     new LAMA called aclidinium has been approved for use in COPD. There are potentially important     differences between these two medications that might have an impact on the treatment of COPD     patients.      In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD.     The main comparison will be done using a very sensitive breathing test called impulse     oscillometry   "
95252|NCT02039349|"     Background:      - Hormones are naturally occurring chemicals in your body. Ghrelin is a hormone that is     mainly produced by the stomach and stimulates appetite. Some studies suggest it may stimulate     alcohol craving and use. Drugs have been developed that block ghrelin. Researchers want to     know if people can tolerate a particular drug that blocks ghrelin. It will be given at two     dose levels, combined with alcohol.      Objective:      - To determine if a drug that may decrease alcohol consumption when given along with alcohol     is safe and tolerable.      Eligibility:        -  Healthy adults 21 65 years old who have 14 (women) to 21 (men) drinks a week.        -  No one of childbearing potential can participate.      Design:        -  Participants will have 3 inpatient clinic visits; each will last 4 days.        -  They will have physical exam and blood and urine tests.        -  They will have breath tests for alcohol and smoking.        -  They will answer health and mood questions.        -  Researchers will measure their reaction to smelling alcohol and tasting a sweet drink.        -  They will eat only the food provided by the clinic. They will keep a food diary 1 day          before each stay.        -  They will be randomly assigned to take the study drug or placebo 5 times each stay.        -  On Day 3, they will drink alcohol after taking the drug. They will give many blood          samples that day through a tube inserted in their skin.        -  Smokers can take smoke breaks. Once, they will smoke a cigarette through a device.        -  One week after the last stay, participants will have a follow-up visit to answer          questions.   "
95253|NCT02039336|"     This is a phase I/II multi-center open-label proof of concept study, consisting of two parts.     Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the     combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant     (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized     comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy     in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy     the progression free survival of patients with KRASm NSCLC will be doubled.   "
95254|NCT02039323|"     The purpose of this study is to determine the feasibility of a novel method to assess     antiretroviral efficacy for protection against HIV-1 infection in vaginal and cervical tissue     biopsies.   "
95255|NCT02039310|"     The investigators proposes a prospective cohort study in patients with high risk bladder     cancer who have opted for radical cystectomy. The investigators aim to correlate     pre-operative measures of body composition, cognitive and functional status with impaired     survival at 6 months after cystectomy. Impairment in this context will be a compilation of     several specific objective measures including: 1) death from any cause, 2) major complication     (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5)     global well-being. The study team believes that Impairment Free Survival is an important     endpoint as it accounts for many aspects of a patient's functional status that might alter a     patient's choice to proceed with radical surgery.   "
95256|NCT02039297|"     In this multicenter project, we will introduce AWARE (electronic interface) Using a     cloud-based technology . The goal of this project is to improve compliance with best practice     through the use of a new acute care interface with built-in tools for error prevention,     practice surveillance and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic     System: Ambient Warning and Response Evaluation).The goal of this project is to develop and     test a novel acute care interface with built-in tools for error prevention, practice     surveillance, decision support and reporting (ProCCESs AWARE - Patient Centered Cloud-based     Electronic System: Ambient Warning and Response Evaluation). In preliminary studies, these     novel informatics supports built on an advanced understanding of cognitive and organizational     ergonomics, have significantly decreased the cognitive load of bedside providers and reduced     medical errors. Using a cloud-based technology, AWARE will be uniformly available on either     mobile or fixed computing devices and applied in a standardized manner in medical and     surgical ICUs of five geographically diverse acute care hospitals predominantly serving     Medicare and Medicaid patients. The impact of ProCCESs AWARE on processes of care and     outcomes in study ICUs; expected to enroll more than 10,000 critically ill patients during     the study period.   "
95257|NCT02039284|"     Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and     loss of dexterity are the major problems in patients with CP. A novel virtual cycling     training (VCT) program for lower limb was to enhance promising muscle strength through     promoting the participant compliance and motivation. Sensory electrical stimulation(SES) of     whole hand is a novel technique and is commonly used to treatment of spasticity for patients     with stroke. Constraint-induced therapy (CIT) is a method for treating developmental     disregard and learned non-use of affected limb and improving motor efficiency, functional     performance, and activities of daily living for patients with CP.   "
95258|NCT02039271|"     The aim of the present study is to determine if the use of music as an intervention can be     utilized, in conjunction with normal pharmacological treatment, in decreasing pain and     increasing patient satisfaction, in male and female total knee replacement patients, from the     age of 50 and 70, during the first 48 postoperative hours after surgery. It is the hope that     this study can add to current research addressing the pain relief needs of orthopedic     patients following total knee replacement surgery using music listening as an adjuvant     therapy.   "
95259|NCT02039258|"     The purpose of this study is to assess the effect of coadministration of a high-fat meal on     the oral bioavailability of a fixed dose combination of Canagliflozin/extended release     Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in     healthy participants.   "
95260|NCT02039245|"     The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2     Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150     mg/1,000 mg each) following once-daily oral dosing in healthy participants.   "
95261|NCT02039232|"     The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw     System in the lumbar spine.   "
95262|NCT02039219|"     The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in     patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals     with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a     product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been     shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may     improve liver condition in individuals with alcoholic hepatitis.   "
95264|NCT02039193|"     Background: Psychotherapy is an effective treatment for generalized anxiety disorder in     comparison to no-treatment controls. Instead of creating more and more new overall     treatment-packets within a medical meta-model, a complementary approach to investigate     clinical research designs may lie into the understanding of already effective     psychotherapies. Treatment manuals and protocols allow a relatively high degree of freedom of     therapists' behaviors on how to implement the overall treatment manuals. There is a lack of     systematical knowledge of how therapists have to customize these overall protocols. The     present design experimentally examines 3 types of conducting a 15 session time-limited     cognitive-behavioral therapy (CBT) protocol and its relation to the therapists' protocol     adherence and treatment efficacy.      Methods/design: This trial investigates 3 different types of how to customize a     well-introduced CBT-protocol using dyadic peer tutoring methodology (primings). The     individuals with GAD are randomly assigned to 3 priming conditions (resource priming vs.     supportive resource priming vs. adherence priming). Participants' treatment allocation is     performed randomly, therapist's assignment to the peer tutoring partner and the priming     condition is based on mutual agreement. Treatment outcomes are assessed at following levels:     Observer based in-session outcomes, post-session outcomes from session 1 to 15, treatment     outcome at post assessment and at 6-months follow-up assessments.   "
95265|NCT02039180|"     This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single     doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered     with a washout period of at least 1 week between the doses to investigate the relative     bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral     solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations     compared to the oral solution of AZD3293.      The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the     study. AZD3293 is being developed for the treatment of Alzheimer's disease   "
95266|NCT02039167|"     The purpose of this study is to evaluate the superiority of left atrial appendage occlusion     in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the     frequency of occurrence of at least one bleeding classified as moderate or major within 24     months.   "
95267|NCT02039154|"     The purpose of this study is to determine whether vigorous exercise training 4-5 days/week     for 2 years in sedentary middle aged men and women (ages 45-64) will improve cardiac and     vascular compliance to a degree equivalent to life-long exercisers and the sedentary young.     Sedentary aging is associated with impaired diastolic function, which can lead to heart     failure. However, if exercise training can be implemented early enough in life while     cardiovascular plasticity still exists, then functional capacity can be maintained,     preventing heart failure.   "
95268|NCT02039141|"     The purpose of this study is to examine the effects of 12 week lifestyle intervention on     diabetes risk in obese Latino adolescents.   "
95269|NCT02039128|"     In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d     krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed.      Primary objective is to determine if a 12 week supplementation with krill oil increases     tissue levels in erythrocytes (omega-3 index) significantly more than fish oil after dose     adjustments to EPA and DHA levels.   "
95270|NCT02039115|"     Complete endoscopic resection of early neoplastic BE is a curative procedure. However, a     significant proportion of patients develop symptomatic esophageal strictures following CBE,     and this limits the technique, particularly for circumferential and longer segment disease.     Oral steroid therapy may reduce stricture formation; thereby allowing CBE to be performed     with minimal associated morbidity.   "
95271|NCT02039102|"     Studies examining the sex differences in the epidemiology and morbidity patterns of asthma     show that the rates of disease severity, healthcare utilisation, and poor quality of life are     considerably higher in women than in men, and this has been attributed to endogenous and     exogenous sex hormonal factors. Studies examining the impact of use of hormonal     contraceptives on the risk of asthma and asthma-related conditions are few, yet findings are     conflicting.      In the present study, the investigators utilize data from the Scottish Health Survey, a     national representative sample, to investigate the associations between current use of     hormonal contraceptives and the prevalence of self-reported doctor-diagnosed current asthma     and wheezing symptoms in Scottish women. The investigators hypothesize that while current use     of any hormonal contraceptives and combined oral pills are associated with higher prevalence     of asthma and asthma outcomes, current use of progesterone-only contraceptives is not     associated with asthma. A secondary aim of the current study is to examine whether there is     evidence of any biological interaction between use of hormonal contraceptives and BMI in     relation to the risk of asthma and asthma outcomes.   "
95272|NCT02039089|"     This study will be a single-center, multiple-dose, randomized, double-blind,     placebo-controlled, parallel-group study in healthy male and female subjects. The study will     consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and     Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be     conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by     the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel     with the 10-mg cohort of Part A, with the possibility of overlap.   "
95273|NCT02039076|"     This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of     avatrombopag following a single administration of avatrombopag in the fed and fasted     condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat,     high calorie breakfast will be used to assess the fed condition.   "
95274|NCT02039063|"     This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to     evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of     E6011. A total of 24 subjects will enroll into four cohorts. Six subjects per cohort will     receive repeated intravenous administration of E6011.   "
95346|NCT02038127|"     Comparison of        -  Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore        -  Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott,          USA        -  Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent          Medtronic, USA in patients with coronary artery disease treated with percutaneous          coronary intervention   "
95278|NCT02039011|"     Asthma is a common condition which produces a significant workload for general practice,     hospital outpatient clinics and inpatient admissions. Asthma is caused by inflammation of the     airways which irritates the muscles around the airways causing them to constrict. The     mainstay of asthma treatment is inhaled steroids. If the patients' symptoms are still not     adequately controlled, then a long-acting beta agonist (LABA) inhaler which relaxes the     muscles in the airways and opens it up is frequently added to the inhaled steroids. Despite     this, a substantial proportion of asthmatic patients still do not achieve adequate control of     their symptoms. Recent studies have shown when an alternative inhaler called a long-acting     muscarinic antagonist (LAMA) is added to a LABA - it reduced the number of asthma     exacerbations (flare-ups) and improved airway narrowing.      The mannitol challenge is a test of airway 'twitchiness', an important feature of asthma.     There have been no previous studies assessing the combined effects LABA and LAMA inhalers on     mannitol challenge. The mannitol challenge is particularly relevant as it mimics stimuli     encountered in real life which provoke an asthma attack.      The investigators propose to directly compare indacaterol, a new once-daily LABA with     indacaterol plus tiotropium, a once-daily LAMA, as add-on treatment to inhaled steroids in     persistent asthmatics using the mannitol challenge. The investigators hope that this study     will help us understand how the combination of a LABA and LAMA might help protect against     flare-ups.   "
95279|NCT02038998|"     Stroke is one of the leading causes of death and disability worldwide. More than 85% of     strokes are due to blood vessel occlusion resulting in partial destruction of the brain     parenchyma. Current protocols try to re-establish blood circulation as soon as possible     through chemical and/or mechanical interventions but new strategies are needed.      Periodic acceleration (pGz) is a non-invasive method consisting in the application of a     rocking movement to the patient that ultimately will induce the release of beneficial     chemicals from the vascular endothelium (the cells lining the inside of the blood vessels).     Application of pGz in an animal model of stroke resulted in a dramatic reduction of     associated brain damage.      This trial will investigate whether stroke patients exposed to pGz experiment significantly     higher recovery than patients that remained static during their treatment.   "
95280|NCT02038985|"     The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green     (ICG) dye (Firefly), compared to standard white light imaging in 2D and 3D, for accurate     visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis     resection procedure.   "
95281|NCT02038972|"     To determine if autologous human umbilical cord blood infusion in children with acquired     hearing loss is safe, feasible, improves inner ear function, audition and language     development.   "
95282|NCT02038959|"     Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care     enhanced with educational materials to usual care, educational materials, and the delivery of     specialty care via telemedicine into patient's homes. The study's specific aims are the     following:        1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the          homes of individuals with Parkinson disease who have limited access to care;        2. To show that such an approach can improve quality of life;        3. To establish that the telemedicine can enhance the quality of care; and        4. To demonstrate that this remote approach to care saves time, reduces travel, and          decreases care partner burden.   "
95283|NCT02038946|"     The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by     independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in     subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating     agent.   "
95284|NCT02038933|"     The purpose of this study is to determine whether Nivolumab is effective in the treatment of     DLBCL in patients that have failed or are ineligible for ASCT   "
95285|NCT02038920|"     This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,     parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002     (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or     severely active Crohn's disease.   "
95286|NCT02038907|"     The purpose of this study is to select the optimal formulation of the norovirus vaccine from     different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant     (3-O-desacyl-4'-monophosphoryl lipid A) for further development.   "
95287|NCT02038894|"     The purpose of this research study is to compare the safety and effectiveness of three     commonly used techniques for delivering anesthesia during a procedure known as     esophagogastroduodenoscopy.   "
95662|NCT02033993|"     The purpose of this study is to compare the effects on urothelial cancer of nab-paclitaxel     compared to paclitaxel to treat this disease.      This research is being done because currently there is no effective treatment for urothelial     cancer that has progressed after prior chemotherapy.   "
95288|NCT02038881|"     The main purpose of this clinical trial is to generate additional safety data in a highly     immunocompromised population. HIV-infected persons are considered excellent candidates to     represent the highly immunocompromised population for enrolment in this trial. Additionally,     the immune system's response (protection against smallpox as measured by the amount of     antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All     participants in this trial will be randomly and evenly assigned to one of three groups to     receive two, three or four injections. Group 1 will receive the standard regime consisting of     one dose at each vaccination time point, Group 2 will receive two doses at each vaccination     time point and Group 3 will receive a booster vaccination 12 weeks after the first dose of     the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation in the trial     is scheduled to last up to 48 weeks.   "
95289|NCT02038868|"     The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with     benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.   "
95299|NCT02038738|"     Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The     68Ga-DOTATATE PET Scan is a novel scanning method that may have improved sensitivity and     resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will     be imaged with this agent and it will be compared to conventional imaging methods to     determine the safety and efficacy of this radiopharmaceutical.   "
95290|NCT02038855|"     Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for     Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and     intervention project designed to improve the quality of care for Latino patients with     comorbid mental health and substance use problems. We will first test a screening of comorbid     problems with patients identified in mental health as well as primary health care. Building     on that work, we will test the feasibility, acceptability and efficacy of the Integrated     Intervention for Dual Problems and Early Action (IIDEA) intervention addressing mental     health, substance use, and prevention of HIV, as well as a smoking cessation supplement. The     project is being conducted in Massachusetts as well as at two sites in Spain. As such, the     proposed ILRP multi-site international project is a critical step towards developing models     of integrated care for the large and diverse Latino migrant population and more broadly     towards understanding how best to integrate evidence-based assessment and treatments for     co-occurring substance and mental health problems and HIV risks.   "
95291|NCT02038842|"     The development of a safe and effective HIV-1 vaccine strategy would probably be the best     solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost     immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus     relevant to pursue the development of different candidate vaccines in prime-boost vaccine     strategies to identify the most promising prime-boost combinations and to integrate     scientific inquiry into trial protocols from the beginning to maximize learning     opportunities.   "
95292|NCT02038829|"     Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium     bromide 400 mcg 2x a day will be given as an active comparator.   "
95293|NCT02038816|"     Myelodysplastic syndromes are common blood disorders that can affect as many as one in 1000     Canadians over the age of 65. They are characterized by low blood counts that require     frequent blood transfusions. The development of iron overload in these patients is     inevitable. The iron deposits in vital organs such as the heart and the liver and can lead to     organ dysfunction. Deferasirox is a well-studied drug that helps remove iron from the body.     Most people with this disorder die due to progression of their disease to acute leukemia     through multiple mechanisms. Iron overload in patients with myelodysplastic syndromes has     been shown to be associated with shorter survival, and potentially a higher chance of     leukemia. In a certain sub-group of higher risk patients, the drug azacitidine has been shown     to decrease the chance of progression to leukemia and death from it. Thus, it is presently     the standard of care for these patients. However, 50% of higher risk patients are still     unresponsive to this medication, leaving a large group of patients for which other treatment     options are emergently needed. Given that a large proportion of higher risk MDS patients fail     to respond to azacitidine, and the evidence that iron deposition may lead to increased     leukemic transformation, we would like to study whether iron removal from the body with     deferasirox potentiates azacitidine in its effects on overall survival, as well as the chance     of leukemia transformation. This question needs to be addressed in a randomized controlled     trial, and the first step is a preliminary study to determine if the combination of     azacitidine and deferasirox has any biologic effect. This study will determine whether this     combination leads to blood count improvement over azacitidine alone. If this drug combination     ultimately proves more useful than azacitidine alone with respect to survival, this has the     potential to impact the care of a large proportion of patients with myelodysplastic     syndromes.   "
95294|NCT02038803|"     Inhaled tobramycin is a Cystic Fibrosis Foundation recommended effective treatment for     individuals with cystic fibrosis for the management of Pseudomonas aeruginosa airway     colonization and improves the FEV1 and reduces the number of acute pulmonary exacerbations of     CF. Patients typically use the inhaled tobramycin for a period of 28 days. Unfortunately, the     standard nebulizer method for delivering tobramycin inhaled solution (TIS) is time-consuming     and may result in missed therapy doses and suboptimal care. A new inhaled formulation and     delivery device, the TOBI Podhaler (TPI), is a quicker, more efficient method of     administering inhaled Tobramycin. This new pocket-sized disposable inhaler is maintenance     free, requires no refrigeration or power source, and should greatly increase patient mobility     and improve time management.   "
95295|NCT02038790|"     The primary objective of this study is to compare overall patient preference for either     Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual     film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7     mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs     like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of     time.   "
95296|NCT02038777|"     This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients.     PF-04449913 will be administered orally as a single agent in patients with select advanced     hematologic malignancies, or in combination with LDAC [Low-Dose Ara-C] or cytarabine and     daunorubicin in previously untreated patients with AML [Acute Myeloid Leukemia] or high-risk     MDS [Myelodysplastic Syndrome].   "
95297|NCT02038764|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.   "
95309|NCT02038608|"     Parkinson's disease is characterized by a large number of non motor, especially     neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and     serotoninergic systems dysfunction is suggested by several studies. In addition, the     serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies     have analyzed the abnormalities of these two neurotransmission systems at disease onset, in     de novo PD patients. Furthermore, the parallel evolution of the degeneration of the     dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the     present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role     of the serotoninergic and dopaminergic systems dysfunction in motor and non motor     manifestations in PD, at different evolution stages.   "
95298|NCT02038751|"     The growing evidence showed that the OSA is a heritable complex genetic disease where the     genetic basis contributed the development of OSA and its sequel. The phenotyping of OSA     include high level and intermediate level. The former indicates the AHI, and later includes     craniofacial morphology, ventilator control, obesity, and sleepiness vulnerability.      Many studies tried to determine the association of candidate genes with OSA through     association studies. However, the results were conflicting. We identified 37 candidate genes     involved in six biologic pathways of OSA reported in previous literatures, including     oxidative phosphorylation, cell signaling, apoptosis, cellular adhesion and motility, cell     cycle, and cytokine/chemokine.      To investigate the association between phenotype and genotype of OSA, we conducted this     cross-sectional study by recruiting the patients of moderate-severe OSA (index proband) and     their first and second-degree family members, and friends and their family members (control     family) and using candidate genes reported in the literature and whole genome SNP array for     genotype approach.   "
95300|NCT02038725|"     Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment     and treatment can reduce the risk. Several international guidelines recommend a test, the     ABCD2 score, to identify TIA patients with low and high risk for stroke. The main purpose of     this study is to investigate stroke risk after TIA in both short (1 week) and long term (3     months/1 year), and to assess whether the Age, Blood pressure, Clinical features, Duration of     TIA, Diabetes (ABCD2) score is a sufficient tool for predicting stroke risk. Secondary aims     are to explore whether adopting imaging modalities (ultrasound, MRI) and biological markers     of blood into a risk score could improve the predictive value of the ABCD2 score and still be     feasible in a daily clinical practice. Further on overall risk factors in TIA patients, and     the incidence of other vascular events will be studied. A substudy designed as a randomised     controlled trial evaluates pharmaceutical counseling in a subset of participants.     Cost-benefit analysis, and a long-term follow-up (5 years) is planned.   "
95301|NCT02038712|"     Binge Eating Disorder (BED) may be associated with he development of obesity. However, the     pathogenesis of BED is currently unclear, thus making the development of treatment and     prevention strategies for BED difficult. Differences in the mechanisms regulating food intake     may go some way to reveal potential mechanisms for BED.The purpose of this study is to     investigate the responses of key gut-derived hormones that are associated with the regulation     of food intake and functional brain activity to food cues using fMRI in BED patients and     weight matched controls.   "
95302|NCT02038699|"     ONC201 is a new potential drug that kills cancer cells but not normal cells in laboratory     studies. This clinical trial will be the first evaluation of ONC201 in humans and will enroll     patients with advanced cancer. This trial includes a phase I portion that will evaluate the     safety of ONC201 and the recommended dose for the phase II portion. The phase II portion will     evaluate the initial efficacy profile of ONC201 in select types of cancer.   "
95303|NCT02038686|"     1. Introduction:           Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma          Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an          intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is          performed to compare the outcome treatment of these unstable fractures of the proximal          part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm).        2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer          complications than Long PFN-A           Main Objective: Is defined as Total number of complications between PFN-A short and          PFN-A long. Outcome measures were subdivided into preoperative, perioperative and          post-operative. Follow up data at four weeks, three months and one year.           Secondary objectives: Complete and uneventful radiological and clinical healing of the          fracture. Revision operations (related to the failure of primary treatment) and          mortality. Baseline characteristics were documented pre-operatively: Outcome measures          were subdivided into intra-operative, post-operative and follow up data at four weeks,          three months and one year.        3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and          31-A3 fracture of the proximal part of the femur will be randomized, at the time of the          admission, to fixation with use either a short PFN-A or a long PFN-A.   "
95304|NCT02038673|"     The objectives of this study are to determine the tolerability, safety, pharmacokinetics     (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in patients with solid tumors.   "
95305|NCT02038660|"     The purpose of this study is to evaluate long-term effectiveness and safety of patients with     coronary disease treated with drug eluting balloon in real world practice.   "
95306|NCT02038647|"     This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study     designed to is to determine if the combination treatment can improve progression free     survival (defined as the time from the date of randomization to the date of first     documentation of disease progression or death, whichever occurs first) when compared with     placebo + paclitaxel.   "
95307|NCT02038634|"     The investigators aim to perform a prospective study to evaluate the effectiveness of blind     corticosteroid injections to US-guided injections for the treatment of de Quervain's disease.     The results of the study will be used to validate current injection protocols or support the     incorporation of ultrasonography to treat the disease.   "
95308|NCT02038621|"     To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of     advanced gastric cancer (AGC)   "
95310|NCT02038595|"     This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing     the norepinephrine transporter.   "
95311|NCT02038582|"     The purpose of this study is to determine efficient, scalable, evidence-based strategies to     link HIV positive individuals to care and HIV negative individuals to prevention measures,     such as voluntary male circumcision.   "
95312|NCT02038569|"     An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial     in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.   "
95314|NCT02038543|"     Primary hyperoxaluria is an inborn error of metabolism that results in marked overproduction     of oxalate by the liver. The excess oxalate causes kidney failure and can cause severe     systemic disease due to oxalate deposition in multiple body tissues.      Metabolic pathways that lead to oxalate are poorly understood, but recent evidence suggests     that hydroxyproline may play a role. Sources of hydroxyproline include the diet and bone     turnover. If hydroxyproline can be confirmed as a significant factor in primary     hyperoxaluria, diet modification might be of value in reducing the severity of disease.      This protocol, in which hydroxyproline labelled with a cold isotope is infused intravenously     in patients with primary hyperoxaluria, will allow the researchers to measure the amount of     oxalate produced from hydroxyproline. The contribution of hydroxyproline metabolism to the     amount of oxalate excreted in urine in will be able to be determined for patients with each     of the known types of primary hyperoxaluria.   "
95315|NCT02038530|"     This is a cohort study that will assess a new diagnostic management strategy for suspected     Deep Vein Thrombosis in outpatients.The new diagnostic strategy is designed to reduce the use     of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week     after an initial normal test.   "
95319|NCT02038478|"     The design of the study incorporates the following features:        1. This is a phase II study to determine the safety and therapeutic potential of a new          transplant approach (disease-free survival, graft versus myeloma effect) and to evaluate          its toxicity profile (immediate toxicity, graft-versus-host disease, graft rejection,          mortality) in a patient population with severe congenital anemias.        2. The patient cohort to be studied: Those patients with severe sickle cell disease and          thalassemia who have risk factors for high mortality and morbidity related to their          disease        3. Transplant Conditioning Regimen - Immunosuppression without myeloablation: Patients will          receive conditioning sufficient to allow donor lympho-hematopoietic engraftment without          complete marrow ablation. If the graft is rejected, the patient will reconstitute          autologous marrow function. We will use a combination of low dose irradiation,          Alemtuzumab (Campath®), and sirolimus.        4. Peripheral blood hematopoietic progenitor cell (PBPC) transplant: An unmanipulated          peripheral blood stem cell collection from a filgrastim (G-CSF) stimulated HLA-matched          donor should improve the chance of engraftment because of the high stem cell dose (5 x          106/kg CD34+ cells) and the presence of donor lymphocytes. To reduce the risk of GVHD,          patients will receive sirolimus before and after the transplant. The sirolimus will be          tapered as necessary to minimize any graft versus host disease while still maintaining          adequate chimerism.   "
95320|NCT02038465|"     The aim of the study is to assess the efficiency of SenseCam® in patients with schizophrenia     by comparing two cognitive remediation methods of autobiographical memory.Patients and     control participants will be invited to carry SenseCam® during 7 hours per day minimum and     for 4 successive days. Each ending day when carry SenseCam®, they will be asked to go to the     laboratory where 4 types of interventions will be successively done according to the     randomization: 1) a simple visual retrospective procedure (SVR), 2) a visual retrospective     procedure coupled with a specific cueing intervention (VR-SC), 3) a verbal retrospective     (VbR) and 4) no intervention (control condition).The testing phase will take place 14 days     after the last day of data collection and will consist in a cued recall task and a     recognition task using the pictures obtained by the SenseCam® of the participants.According     to our hypotheses, the vividness of memories will be higher in events subjected to the VR-SC     procedure than in events subjected to the SVR and VbR procedures. This effect is expected for     both patients with schizophrenia and controls participants. Since strategies to enrich memory     details will be explicitly given to the patients when using the VR-SC procedure, we assume     that patients will be able to normalize their scores.   "
95321|NCT02038452|"     Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median     nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling     or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day     things.      There have been several studies into the best treatment of patients with severe symptoms of     CTS who are referred to a hospital for treatment. However, little is known about the best     treatments for patients with mild to moderate symptoms who visit their GP but do not require     hospital treatment.      The study will investigate whether a steroid injection is clinically effective in reducing     symptoms and improving function in the short term (6 weeks) compared to a night splint in     people consulting with mild to moderate CTS in primary care.We will study the effects of     these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will     also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.      The study will take place in up to 50 GP practices and hospital clinics across the UK.     Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been     present for at least 6 weeks will be eligible for inclusion.      The steroid is a drug called DepoMedrone. This drug is already widely used to treat CTS. In     this study, one injection will be given. The splint is made of elastic and has an aluminium     bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6     weeks. Each participant will receive either a single steroid injection or a splint, and will     be asked to complete up to 5 questionnaires over 2 years.   "
95361|NCT02037932|"     The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm     occlusion and retreatment rates as well as adverse event rates in patients undergoing     balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and     second-generation MicroVention hydrogel coils for treatment of previously treated or     untreated ruptured and unruptured intracranial aneurysms.   "
95322|NCT02038439|"     Translation of new knowledge from research into evidence-informed health care is a shared     obligation of the clinical and the scientific communities. Unfortunately, studies of quality     of care continue to show that this goal is substantially unrealized. One main barrier is lack     of quick and easy identification, appraisal and synthesis of current best evidence.     Clinicians' information have 5 to 8 questions about individual patients per daily shift, but     face a large volume of 3000 articles published every day, accessible in many scattered     resources.      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,     Canada) has developed and implemented McMaster Premium LiteratUre Service Federated Search     (MPFS), an online search engine that provides a unique 1-stop search and organized access to     current best evidence in daily practice. However additional barriers need to be overcome for     clinicians to actually search and use this evidence in their practice. Theses include     logistical barriers (time constraints, forgotten questions), as well as educational barriers     (eg, lack of awareness of the architecture of evidence, limited searching skills, and lack     of reference standards among peers for finding best evidence).      This randomized trial seeks to test 3 innovative online interventions among clinicians     registered to MPFS to overcome these barriers and increase the quantity and quality of     searching for current best evidence to answer clinical questions. These interventions build     on effective models for the teaching of clinical skills at the point of care, so that     clinicians are facilitated in using the search engine as a clinical tool, and perceive     evidence retrieval skills as true clinical skills.   "
95323|NCT02038426|"     Purpose:        -  Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects,          athletes or not        -  Comparison of the ultrasound semiology of enthesitis in the 3 populations        -  Comparison of the MASEI scores in the 3 populations   "
95324|NCT02038413|"     Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the     potential to inflict maximum damage on tumors with minimum collateral damage to neighboring     healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than that     of conventional radiotherapy (RT) with photons, it is necessary to establish whether these     higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the     situations in which PT outperforms conventional photon treatment is needed.      In a previous ROCOCO study (lung stage I-IIIB) an inhomogeneous group of patients with regard     to tumor stage and size was included1. Conformal radiotherapy and Intensity Modulated     Radiotherapy were used in the comparison. In this study patients with smaller tumors are     included (stage I). A stereotactic treatment schedule and more advanced treatment techniques,     such as CyberKnife, RapidArc, IMRT and Tomotherapy, are eligible for these kind of lesions.     As a result the comparison as demonstrated in our previous study maybe invalid. We propose to     investigate to what extend proton and 12C-ion therapy decrease the amount of irradiated     normal tissue compared to state of the art photon modalities in stage I lung cancer patients.   "
95325|NCT02038400|"     Otitis media are the consequence of bacterial infection. They are characterized by middle ear     inflammations with a collection of fluid behind the eardrum. The effusion stagnates in the     middle ear, can increase acute infection and induce tympanic membrane and inner ear damages.     Delay in language learning can be observed in affected children as well as hearing problems     e.g. constant hearing loss. The two main forms of chronic otitis are otitis media with     effusion (OME) and atelectasis with or without retraction pockets.      To date, insertion of tympanic ventilation tubes (tympanostomy) is the most effective     treatment for otitis media with effusion that has failed to respond to conservative drug     treatments; and for delaying the progression of serious atelectasis. When a first tube did     not allow complete recovery, recurrence is then observed and insertion of new tube is needed.     The repeated tube insertions increase risks linked to general anesthesia and increase rate of     sequelae/complications, such as tympanic membrane perforation.      Kinetube® is a CE-marked medical device, marketed in France and Europe since April 2002. This     device improves the neuronal control mechanism of the pharyngotympanic (Eustachian) tube,     regulating middle ear pressure. This could be an alternative for patients having recurrence     and needing repeated tube insertion, as studies had shown that Kinetube® improved the opening     of the Eustachian tube in patients with otitis media with effusion (OME) and atelectasis.      These previous clinical studies have shown the feasibility of the use of Kinetube® in     clinical practice. A larger clinical study with a high level of evidence must be performed to     show therapeutic efficacy of the Kinetube® in chronic otitis compared to ventilation tube     insertion.   "
95326|NCT02038387|"     Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are     characterized by a spectrum of pathological conditions ranging from an early stage of     inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular     carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large     differences in age and ethnic groups, while it is well known that HCV infection is a major     cause of chronic liver disease in Western countries.      For both diseases the progression of liver damage is in close correlation with the lifestyle     of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was     shown that feeding imbalances may have implications in altering the normal immune functions     of the subjects, suggesting that the metabolic and the immune systems are closely related to     each other. Although it is well known the negative role of obesity on the progression of     NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to     the immune response is not yet fully understood. Insulin resistance, altered lipid     metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are pathogenic     mechanisms that induce liver damage and its progression, both in NAFLD and in HCV infection.      Recent studies suggest that the evolution of viral infections and chronic inflammation in     NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17     (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV     infection in the activation of Th17 cells and in the alteration of some of their functions,     will allow to shed light on the pathogenic mechanisms underlying the progression of     immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17     cells may have a role in the diminished response to therapy in patients who have high     cholesterol levels.      If the results will confirm our hypothesis, this study will provide useful informations for     the clinical management of patients with both steatosis and chronic HCV infection. The data     obtained can also be used for the development of new therapeutic strategies directed to     modulate the antiviral immune response.      All patients will undergo clinical and instrumental assessment depending on the type of     pathology. Patients will be required to follow a normocaloric low cholesterol diet for a     period of 30 days.      The prospective clinical study does not present any form of additional risk for the patients     and will be conducted in accordance with the principles established by the Declaration of     Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require     any additional costs.   "
95362|NCT02037919|"     Women who receive Nexplanon immediately post abortion will be significantly more likely to be     using the device 6 months after the procedure than those assigned to receive the device 2-4     weeks after the procedure.   "
95327|NCT02038374|"     Asthma is the most common chronic respiratory disorder in children. Despite significant     advances in understanding of asthma, available therapies fail to alter the natural history     and progression of the disease. Airway epithelial cells are continuously exposed to and     injured by environmental irritants, such as viruses and pollutants, and as such are ideally     situated to orchestrate airway function in response to these stimuli.      Severe or difficult-to-treat asthma in children is a complicated disorder characterized by     ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid     treatment. Although severe asthma is likely a heterogeneous disorder, affected children     similar clinical features, including gas trapping, bronchial hyperresponsiveness, and     aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in     children with severe asthma are not uniform : some investigators have found increased     eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with     neutrophil activation.      Given the heterogeneity of the inflammatory response in children with severe asthma,     additional methods to distinguish severe asthma are needed.   "
95335|NCT02038270|"     The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff     manometer, combined with NIRS technology. The accuracy of the signal is dependent on the     degree of vascular unloading, which takes an period before optimal unloading is reached. The     evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the     absolute and relative inaccuracy of the nexfin as a function of the time is determined     compared to the invasive blood pressure (IBP).      Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of     noninvasive blood pressure to predict the IBP.   "
95336|NCT02038257|"     The purpose of this study is to:        1. Compare two different techniques in the melanocyte keratinocyte transplant procedure:          Use of carbon dioxide laser versus use of dermabrasion        2. Compare two different dressings in the melanocyte keratinocyte transplant procedure:          vaseline impregnated gauze versus collagen dressing   "
95328|NCT02038361|"     Acute leukemias are a heterogeneous group of malignancies characterized by the abnormal     proliferation of a cell clone in the bone marrow, having as origin lymphocytic or myeloid     lineage. The repertoire of mutations that determine the leukemic transformation, complex and     variable depending on the tumor type and progression of the disease, combined in the same     cell of balanced and unbalanced chromosomal aberrations, point mutations and epigenetic     abnormalities.      The project presented here is part of a comprehensive approach to diagnosis of hematologic     malignancies of children. Using comparative genomic hybridization on microarray (or array-     CGH) and transcriptome analysis by microarray, two innovative techniques for a comprehensive     analysis of the genome and transcriptome , offer new perspectives identifying molecular     defects . These techniques provide new elements in the identification of acute leukemia at     diagnosis may identify new prognostic factors to optimize the care of patients.      This project involves both the Department of Medical Genetics (Prof. N. LEVY ) regarding the     identification of genomic abnormalities associated with childhood leukemia , the Laboratory     of Hematology of the Hospital de la Timone ( Prof. Pierre Morange ) in terms of the     phenotypic characterization of tumor cells, and the Onco - Hematology Pediatric Department     (Prof. Michel Gerard ) which provides diagnosis, treatment , monitoring and the bone marrow     of children with hematologic malignancies . The following project is mainly focused on the     identification of genomic abnormalities (deletions and duplications) and abnormalities in     gene expression to identify a genetic profile ensuring a better classification within the     different groups risk .      The project we propose is centered on the identification of genomic abnormalities , changing     the number of copies of certain regions of the genome or determining loss of heterozygosity ,     and the identification of changes in the level of gene expression by using two analytical     techniques, comparative genomic hybridization on microarray (or array- CGH) and expression     studies with microarrays . The data generated will , for the identification of  molecular     signatures  , the classification of patients according to prognosis , variations in     treatment response and survival.      The originality of this project lies in the use of these new tools in the diagnosis of     hematological malignancies in children. This pilot study will be conducted with commercial     Affymetrix , will develop the chips ' processing' , dedicated , enriched probes corresponding     to genes involved in leukemogenesis , with high discriminatory power in identifying these     signatures.      The data published in the specialized literature from the study of large series of patients     show that microarrays provide important information for the diagnosis and therapeutic     management of patients. It is for this reason that in the end we hope to integrate these     analyzes in routine diagnosis to complement other analyzes ( phenotyping , identification of     fusion genes and sequencing) in order to further characterize the abnormal cells leukemia and     establish an  identity card of leukemia .   "
95329|NCT02038348|"     Melanoma incidence is increasing in most developed countries. At the metastatic stage, the     prognosis is usually poor. Major advances have been obtained over the last 3 years with the     development of therapies targeting the MAP kinases pathway.      Vemurafenib (zelboraf®) is approved in France since 2012 as first treatment of metastatic     melanoma carrying a B-RAF mutation.      For growth, the tumor needs an adequate supply of nutrients to allow the synthesis of     macromolecules and a contribution in carbon elements to ensure the production of energy. The     nutrition demand is met through greater availability of nutrients via tumor angiogenesis and     through increased intracellular penetration of nutrients via specific upregulation of     transport systems and metabolic pathways.      Scanner is the imaging method most commonly used for the evaluation of therapeutic response.     Such a method gives a morphological indication but does not evaluate the metabolic response.      With the development of functional imaging techniques and the advent of positron emission     tomography (PET), it is now possible to obtain an assessment of the metabolic activity of     tumors. The use of 18F-FDG to assess therapeutic responses to targeted therapies is fairly     recent. The advantage of this approach is well documented for GIST and non-small cell lung     cancer. In melanoma, the metabolic response to 18F-FDG is much faster than the response to     TAP scanner.      18F-FDG tracer that targets glucose metabolism, is the most sensitive functional imaging in     melanoma, which has hindered the development of other tracers such as 18F-FDOPA and 18F-FLT.     The 18F-FDG TEP can thus be used in the initial staging and follow-up of the disease, a     situation in which it can replace the TAP scanner, additional brain imaging remaining     necessary.      The use of metabolic imaging to study the response to targeted therapies in melanoma has been     the subject of only one publications. There was a trend toward improved progression-free     survival in patients with high metabolic response at day J15.      For melanoma, the diagnostic sensitivity of PET 18F-FDOPA is lower than that of 18F-FDG (64%     versus 95%). In contrast, the 18F-FDOPA tracer has the advantage of allowing a brain     assessment, which is critical in melanoma that gives frequent metastases in the central     nervous system. There has never been any evaluation of the metabolic response to targeted     therapies such as BRAF inhibitors PET with 18F-FDOPA.      The investigators propose to conduct a monocentric prospective preliminary study to explore     the potential usefulness of the metabolic PET imaging with 18F-FDOPA in the evaluation of     metabolic response of B-RAF mutated metastatic melanoma treated with vemurafenib.   "
95330|NCT02038335|"     This study is being done to understand if using birth control causes changes in the immune     cells within the reproductive tract of healthy women. Immune cells are important because they     help prevent infections from starting and help fight infections that have started. Immune     cells are also the type of cells that HIV (human immunodeficiency virus) infects so     understanding more about them will help to better understand how to prevent the spread of     HIV.      Immune cells will be studied from the reproductive tract of women who want to start using one     of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the     levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon®     or Nexplanon® ) and the copper IUD.   "
95331|NCT02038322|"     This is a clinical study designed to validate the usability and safety of the     over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease     of use of The Stork™ Conception System and the instructions for use. In addition to     usability, results for safety, including vaginal   "
95332|NCT02038309|"     Study of persistent platelet reactivity during acute coronary syndrome. Patients are included     at admission to the hospital. Platelet aggregation is evaluated by platelet function testing     after blood sampling during hospitalization. No changes in treatment is planned.   "
95333|NCT02038296|"     To evaluate local tumor control and survival rate after repeated transarterial     chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC)     patients.   "
95342|NCT02038179|"     We propose a novel intervention for reducing BP that could have a preferential impact in     patients with hyperuricemia and gout. There is a great need for new anti-hypertensives,     particularly among those with gout. The proposed study is novel in its plans to investigate     the physiologic mechanisms through which urate contributes to vascular disease and by which     ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the     described benefit of lowering serum urate extends beyond the adolescent population previously     studied into young adults, 2) test whether a urate-lowering approach will benefit individuals     that do not yet meet the current definition of hyperuricemia and do not have gout, and 3)     begin to explore potential mechanisms for the higher prevalence of hypertension among     African-Americans. If successful, this work could translate to the standard of clinical care     and to health care recommendations for the population as a whole.   "
95334|NCT02038283|"     Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong     Kong and the second leading cause of cancer death in this population. Several screening     strategies has been associated with improved survival and may affect patients' health-related     quality of life (HRQOL). HRQOL impact should be used to adjust for survival in terms of     quality adjusted life years (QALY) in the evaluation of cost-effectiveness of any     intervention including screening.      Objectives: to determine the HRQOL and health preference of patients with different stages of     colorectal neoplasm, and to determine the most cost-effective CRC screening strategy for     increasing QALYs.      Design and Subjects: A longitudinal survey to collect data on HRQOL associated with     colorectal neoplasm for Markov modeling on cost-effectiveness of CRC screening. A stratified     sample of 420 patients with colorectal polyps and different stages of CRC will be recruited     from colorectal clinics of Queen Mary Hospital for health preference and HRQOL assessment.     The HRQOL over time will be measured at baseline, 6 and 12 months later. Health preference     data will be integrated with cost and effectiveness data obtained from the literature to     determine the cost-effectiveness of currently recommended CRC screening strategies by Markov     modeling.      Main outcome measures: The primary outcome measure is the SF-6D health preference value and     QALYs. Secondary outcomes are the SF-12v2 and FACT-C scores. The outcomes will be compared     between patients with different stages of colorectal neoplasm. Markov modeling study will     estimate the expected QALYs gained and incremental cost-effectiveness ratio for each CRC     screening strategy.      Results: The study will provide information on HRQOL of patients with colorectal neoplasm to     guide health services. The Markov Model will identify the most cost-effective CRC screening     strategy for Hong Kong Chinese, which can inform policy makers and the public for the     prevention of CRC of the population.   "
95338|NCT02038231|"     The goal of study is to develop and test a parenting-focused version of mindfulness     intervention (Parenting Mindfully) to reduce parent stress and prevent adolescent substance     use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that Parenting     Mindfully (PM) will decrease prevent adolescent substance use and HIV risk behaviors and     intentions. Secondarily, PM will improve parenting, and decrease adolescent stress responses.   "
95339|NCT02038218|"     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated     antineoplastic activities in patients with advanced cancers - melanoma, lung, breast and     glioblastoma multiforme (GBM) involving the CNS during a Phase I study. These findings     support the preclinical responses seen in mice bearing intracerebrally implanted human breast     and GBM tumor xenografts. Toxicity was acceptable - hyperbilirubinemia (in patients with     liver disease and/or liver metastasis). No hematological, renal, cardiovascular, behavioral     or cognitive impairment/neurotoxicities were noted during the Phase I human trial or in     previous pre-clinical studies.      The drug is available for use as a soy bean oil/egg yolk lecithin/glycerin water emulsion;     the latter continues to be chemically and biologically stable and safe.      Patients with advanced lung, breast and melanoma cancers spread to the CNS and primary CNS     malignancies will be eligible for enrollment and treatment, providing the required blood and     other eligibility requirements are met. The trial will be 2-tiered - patients with liver     involvement vs. non-liver involvement will be treated with different doses of the drug.      The trial is open and patients are currently being enrolled and treated with the protocol.   "
95340|NCT02038205|"     A prospective cohort follow-up study design is undertaken. Both males and females with mild     to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and     undergo follow up studies for data collection. Controls will also be seen for a one time     visit.   "
95341|NCT02038192|"     Hope is important for family/friends of persons with dementia residing in Long Term Care     Facilities. Our research team has developed a program (Living with Hope) to increase hope and     quality of life of family caregivers. The Living with Hope Program involves a) viewing the     Living with Hope film which features caregivers of persons with dementia describing their     hope and b) a hope activity entitled Stories of the Present. A new Living with Hope film     entitled Connecting with Hope has been produced and will be used in this pilot study. The     purpose of this pilot study is to evaluate the feasibility and acceptability of the Living     With Hope Program and collect preliminary data on the effectiveness of the Living with Hope     Program for family members of persons with dementia residing in Long Term Care.      30 participants will be recruited from St. Joseph's Auxiliary hospital, the Alzheimer's     Society of Alberta, and the Alberta Caregivers Association in Edmonton based on inclusion     criteria. Participants will be randomly assigned to one of three groups: treatment (Watching     a film on hope and Stories of the Present for one month); low dose group (Stories of the     Present only); or usual care group. In all groups measures of hope, quality of life,     self-efficacy and guild will be collected at visit 1, day 7, day 14 and one month in addition     to demographic information. Participants in group 1 and 2 (treatment group) will be asked to     describe what they were thinking about when doing the hope activities on day 7, 14 and one     month using qualitative interviews. At one month all participants will be interviewed using     open ended audio-taped questions to help evaluate the study procedures   "
95343|NCT02038166|"     The purpose of this study is to determine if acquired (partial) Cystic Fibrosis Transmembrane     Conductance Regulator (CFTR) deficiency contributes substantially to the pathogenic     mechanisms underlying Chronic Rhinosinusitis (CRS), creating a localized environment that     impairs mucociliary clearance (MCC).   "
95344|NCT02038153|"     This phase I/II trial studies the side effects and best dose of lenalidomide and how well it     works in treating older patients with acute myeloid leukemia who have undergone stem cell     transplant. Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing.   "
95347|NCT02038114|"     This study will test the impact of newly created and available symptom management patient     education brochures on symptom burden [measured via the Edmonton Symptom Assessment System     (ESAS)], health-related quality of life [measured by the European Organisation for Research     and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)], patient satisfaction     with care [measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire     (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient     Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)], self-efficacy, and     knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are     designed for oncology patients in order to provide a response to symptom screening and are     now a standard part of care. Symptom screening occurs at each visit as patients are required     to fill out ESAS, that asks about their experience with the occurence and severity of     symptoms. The intent of the patient brochures are to acknowledge the screen, validate the     symptom and provide knowledge of self-management strategies for symptoms. The brochures also     provide information to patients about when and how to seek further help from their oncology     team. The hope is that patients will experience a useful response to their screen with all     levels of symptoms-from 0-10 in severity      It is hypothesized that the addition of patient education symptom management pamphlets on 7     of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety,     fatigue, dyspnea and pain) will provide new and meaningful information which will build     knowledge, validate the patient's experience of the symptom, lead to increased satisfaction     with care, improved self efficacy in managing and accessing help for the symptom and     therefore improved health related quality of life.   "
95348|NCT02038101|"     This study is an international, prospective, multi-centred, investigator blinded, randomized     control trial of an educational and feedback-based intervention vs. usual care to study the     proportion of inappropriate TTEs ordered by clinicians in ambulatory care.      The American College of Cardiology collaborated with the American Society of Echocardiography     to develop its Appropriate Use Criteria (AUC) for Echocardiography in 2007, and were updated     in 2011.      We created an innovative education and feedback-based intervention that we hypothesize will     reduce the proportion of inappropriate TTEs ordered in clinical practice. Our objective is to     prospectively study the following intervention in a multicentre, randomized control trial     format to determine if this intervention will reduce inappropriate TTEs and the number of     TTEs ordered in practice.      The study will take place at multiple hospitals in Canada the United States. Participants     include cardiologists and primary care providers (both general internal medicine and family     practice) who provide ambulatory care.      Once cardiologists and primary care physicians are recruited for the study, they will be     randomized into one of two arms: 1) Intervention group, 2) Control group.      A physician's TTE ordering information will be ascertained by review of the individual TTE     order and by review of the patient's medical record. Trained research coordinators at each     site will review the TTE order for indication and review the patient record to ascertain     clinical circumstances regarding the TTE order. The individual research coordinator will     review this information using the 2011 AUC and classify the TTE as Appropriate (A),     Inappropriate (I) or Uncertain (U), and assign the TTE order the most appropriate indication     number accordingly. Research Coordinators will be blinded to which physicians are in the     intervention or control group.      Research Coordinators at each site will be responsible for individual physicians' TTE order     classifications but will be blinded to study group. Once monthly TTE orders are classified     and collated, this information will be transmitted to the central research laboratory, where     a research coordinator will collate all of the results and transmit monthly feedback reports     to individual physicians. The control group will order TTEs as is their usual practice.   "
95349|NCT02038088|"     The purpose of this study is to determine whether the general anesthesia immunosuppressive     could effect hepatitis B Virus replication   "
95350|NCT02038075|"     The primary purpose of this study is to compare the effectiveness of brief     cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal     ideation and attempts (regardless of Axis I or II diagnosis) among active duty military     personnel. The standard null hypothesis will involve tests conducted comparing improvement     following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary     outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide     attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation,     intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along     with remission of psychiatric diagnoses. Secondary purposes include the prospective     investigation of suicide risk factors and warning signs to explore these variables' ability     to predict subsequent suicidal behavior following an index attempt.   "
95351|NCT02038062|"     Ischemic preconditioning is defined as protection from cell damage induced by prolonged     ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce     ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective,     randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of     the calf measurable by near-infrared spectroscopy. In addition to this, the effect of     sevoflurane preconditioning on ischemia of the calf is measured.   "
95352|NCT02038049|"     The aim of this study is to determine if a monoclonal antibody VAY736 can reduce disease     activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo. The study     will also provide the first safety and tolerability information for VAY736 in RRMS patients.   "
95353|NCT02038036|"     This trial will compare the efficacy and safety of ruxolitinib to Best Available Therapy     (BAT) in patients with polycythemia vera (PV) who are hyroxyurea (HU) resistant or intolerant     and do not have a palpable spleen.   "
95354|NCT02038023|"     To determine the percentage of women who achieve anemia correction after a single dose of     1000mg of low molecular weight iron dextran(infed).   "
95355|NCT02038010|"     The purpose of this study is to see whether a combination of two different drugs -     trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating     metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab)     linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called     HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this     study is considered standard treatment for the type of cancer in this study. Participants in     this study have already been treated with trastuzumab and chemotherapy in the past, and their     cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth)     that the researchers think may help T-DM1 to work better.   "
95356|NCT02037997|"     The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy     in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR -     TKI Resistance of EGFR Mutations   "
95357|NCT02037984|"     This study is designed to assess the effect of different dose levels of pneumococcal     polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and     infants.   "
95358|NCT02037971|"     The purpose of this study is to determine the effectiveness of exercise training on improving     sleep in patients with systemic lupus erythematosus.   "
95359|NCT02037958|"     We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced     haemodynamic variability during insertion compared to the tracheal tube, whilst still     maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected     patients.   "
95360|NCT02037945|"     The main purpose of this study is to determine the distribution of 18F Fluorocholine     (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor     regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if     applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.   "
95363|NCT02037906|"     Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal     and ureteral calculus disease. In vitro studies suggest that progressive increase in     lithotripter energy output voltage could produce the best overall stone comminution in     comparison with constant or deescalating energy output. However, it is possible that the     beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked     any marginal benefits for energy output escalation. The Escalating SW method adds the benefit     of less renal tissue injury.      Research Significance:The present study will signifies and evaluates the stone free rates of     three groups of patients with renal stones treated with different SWL energy outputs     (Escalating, Constant and Reduction energy output).      Research Objectives: The aim of this research project is to study the effect of dose     adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and     to optimize the conditions for successful Shock Wave Lithotripsy.      Research Methodology: This clinical trial will be conducted at a tertiary care university     hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for     eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant     dose). Parameter of the three groups will be compared to detect the treatment difference.   "
95364|NCT02037893|"     The primary objective is to compare the effect of treatment with a combination of ear     solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute     otitis media.   "
95365|NCT02037880|"     The purpose of this study is to assess rates of decline in motor and cognitive functional     measures, and to assess potential biomarkers, in order to identify potential outcome measure     appropriate for use in therapeutic clinical trials.   "
95372|NCT02037789|"     Low back pain (LBP) is one of the most common medical problems encountered in daily life; it     is related to disability and work absence and accounts for high economical costs in Western     societies.      Low-back pain is a diverse group of mixed pain syndromes (neuropathic and nociceptive) with     different molecular pathologies at different structural levels displaying similar clinical     manifestations. Currently, there are limited biomarkers (mostly imaging) or clinical findings     that can be used objectively to help the physician in precise anatomic diagnosis leading to     the safest and most cost-effective treatment for the patient (reduction of direct and     indirect costs and improvement of treatment efficacy).      The main aim of this trial is to identify all omics biomarkers associated with     susceptibility to chronic/persistent LBP and its different pathophysiology.   "
95366|NCT02037867|"     Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver     disease is now the 3rd leading cause of premature death in the United Kingdom. The majority     of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes,     injecting drug use) and therefore reversible if caught at a precirrhosis stage. However,     current liver function blood tests are poor inadequate, and subsequently a large burden of     liver disease is currently missed.      A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which     identify liver disease accurately at earlier stages of scarring. The identification of liver     disease in the community, where previous studies have discovered a large burden of previously     unidentified but significant liver disease, is therefore a feasible place to develop new     liver disease investigation pathways using these noninvasive markers.      In collaboration with the Department of Health, Nottingham University Hospitals have     commenced a pilot community liver disease pathway in two General Practices in Nottingham in     February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2     diabetes)are invited to take part in the pathway. Patients undergo a simple blood test     (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver     stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan     values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary     findings show that the pathway accurately identifies patients with early liver scarring and     previously unidentified significant liver disease. The participating General Practitioners     have also noted a striking number of patients finally engaging in important lifestyle changes     following pathway implementation. A second phase of the pilot pathway, in 2 Inner City     General Practices with a total practice population of c.14,000 patients commenced in June     2013.      We have subsequently designed this cohort study, where pilot participants will be consented     for follow up over a long period. We will assess future liver-related and cardiovascular     events (including death), and perform qualitative patient interviews to assess the reasons     for and persistence of lifestyle changes after liver disease investigation. We hypothesize     that stratification of liver disease in the community will unearth a significant amount of     previously undetected but significant chronic liver disease. Moreover, we will evaluate     whether stratification of liver disease using these tests predicts future liver and     cardiovascular disease and death, and whether stratification has an impact on patient's     future lifestyle choices.   "
95367|NCT02037854|"     The purpose of this study is to assess whether food ingredient(s) affect glycemic and     insulinemic responses.   "
95368|NCT02037841|"     Asthma is the most common chronic disease of childhood and is responsible for large portion     of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways allow     for optimal delivery of care and may result in decreased length of stay, leading to important     economic benefits. Weaning of asthma medications prescribed for asthma exacerbation is not     standardized in the current model of care. Currently, weaning is performed by ward     physicians; in a teaching hospital, this most often done by residents staff. Differences in     practice between different physicians, delays in patient assessment and adjustment of     doctor's orders, likely prolong the hospital stay for children admitted with asthma.      This study's main objective is to determine the effect of a nursing-driven clinical pathway     on children's length of stay when admitted to hospital with a diagnosis of acute asthma     exacerbation. The pathway will allow nurses to wean a specific type of     medication(β2-agonist), as compared to the current standard of care, which dictates that a     physician writes an order to wean the medication. Number of administered β2-agonist     treatments will be compared between both groups, as well as asthma-related health care     utilization within two weeks of hospital discharge. Nursing, physician, and patients'     satisfaction with the pathway will be evaluated, and a cost minimization analysis will be     performed.      This study has the potential to improve resource use efficiency, increase patient safety by     avoiding administration of unnecessary medications, and ameliorate quality of care by     standardizing the care of children admitted to the hospital with a diagnosis of acute asthma     exacerbation. The results of the study will be disseminated across the Canadian Health Care     System with the goal of improving outcomes of children admitted to hospitals with acute     asthma exacerbations.   "
95369|NCT02037828|"     Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of     chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis.     Previous studies have found that accelerated loss of forced expiratory volume in 1 second     (FEV1.0) in an individual is considered an indicator of developing COPD. This functional     predictive system, due to lower sensitivity, is very difficult to discover high-risk     population and earlier stage of the disease. The inflammation occurs earlier than the lung     function impairment. Therefore, early detection of the inflammation may theoretically predict     the occurrence of COPD and thus may guide early intervention.      Proteomics techniques and protein chip techniques provides us high throughput screening     method to figure out characteristic inflammatory or metabolic markers of a diseases. It can     be used for searching the biomarkers relating to lung function loss. EBC is collected from     exhaled gas and is a good non-invasive method for exploring the pathologic process of the     airways.      Thus we designed this study to identify potential biomarkers associated with rapid lung     function decline. This study is divided into two parts: 1) screening potential biomarkers     between stable COPD and healthy individuals; 2) verifying significant biomarkers of first     part in a community-based nested case-control population for 2 years.   "
95379|NCT02037698|"     The revascularization of chronic total occlusion of coronary arteries (CTO) is the most     challenging procedure for the coronary intervention. For the initial period for CTO     intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated     with low procedural success rates about 70%. Recently, the success rate of the recanalization     of CTOs has been raised in several studies.      Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting     coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in     contrast to conventional coronary angiography, reducing the deferral rates from CTO     intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help     to determine revascularization strategy and estimate the procedure time, leading to lower     procedural complications. We suggest that success rates and clinical outcome of intervention     of CTO lesion can be improved by pre-procedural CCTA.   "
95370|NCT02037815|"     Osmotherapy has been used as the medical treatment for brain edema and intracranial     hypertension in critically brain injured patients. Measurement of serum osmolality during     osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid     side effect. Serum osmolality is often measured in laboratory by cryoscopic technique as the     reference method. However, in clinical setting, routine measurement of serum osmolality is     not feasible at bedside, either in intensive care unit (ICU) or neurosurgical ward.     Therefore, clinicians usually estimate serum osmolality by using equations derived from serum     osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical     analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol or     hypertonic saline will be used in patients after craniotomy, and serum osmolality will be     measured before and during drug infusion. Investigators hypothesize that the correlation of     measured and calculated serum osmolality is better during infusion of hypertonic saline than     mannitol.   "
95371|NCT02037802|"     pain control in pediatric renal transplant is a major concern. the main goal during     anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to     that of the adult donor. epidural analgesia is thought to be very effective in pain control.     this study emphasises the ease of application of epidural catheter via the caudal route to     the lower thoracic level; avoiding possible complications that may arise from lumbar or     thoracic routes, and its effects on hemodynamics when using analgesic doses of local     anesthetics and narcotics.   "
95373|NCT02037776|"     The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to     placebo in Japanese subjects with Functional Dyspepsia (FD).   "
95374|NCT02037763|"     This is a prospective observational cohort multinational clinical study. There are no     biomarkers to help predict in which patients acute low back pain (LBP) will transform into     chronic low back pain (CLBP). Human variability and different common comorbidities complicate     the picture and make stratification of patients into correct subgroups difficult. However,     drugs act by targeting specific molecular pathways and are therefore efficient only in a     subgroup of patients sharing common molecular pathology and common genetics. Both CLBP and     disc degeneration are known to be heritable. Little investigation has taken place for genetic     variants in CLBP. The main aim of this trial is to identify omics biomarkers associated     with the transition from acute (single episode of low back pain) to persistent/chronic LBP     (pain lasting more than 12 weeks).   "
95375|NCT02037750|"     The purpose of this study is to conduct a randomized effectiveness trial to determine whether     adding a preventive intervention at the transition from elementary to middle school is     effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use,     participation in HIV- risking sexual behavior, delinquency, mental health problems, and     school failure for young adolescents in foster care. The proposed LINKS intervention marries     the goals of child welfare and educational systems. The aims are: a) to determine the     effectiveness of the LINKS intervention on key behavioral health and school adjustment     outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement     failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to     examine cost effectiveness and cost avoidance of LINKS.   "
95376|NCT02037737|"     The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients     with inadequate response to one or more conventional Disease Modifying Against Rheumatism     (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate     over 2 years and reasons of discontinuation   "
95377|NCT02037724|"     The consequences of iron deficiency anemia in women are enormous, and especially in     developing countries, as the condition adversely affects both their productive and     reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators     among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement,     and 2) determine the suitable level of food supplement needed to prevent/reduce iron     deficiency anemia among women in developing country settings.      A double-blind, randomized, controlled, intervention trial will be implemented in women of     childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency.     After screening potential subjects (up to 500 expected), approximately 30 will be recruited     into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in     ferritin as significant between the two time points at 80% power and alpha value of 0.05.     Subjects who meet the inclusion criteria will be randomized into the four groups consisting     of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate     (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich     supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks     while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12     consecutive weeks.   "
95378|NCT02037711|"     Pain after laparoscopic surgery has been associated with surgical manipulations, including     intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching,     diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas     in the abdominal cavity after surgery. These effects may result in the irritation of     peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures     in pediatrics.      The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation     can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not     always be uniform throughout the peritoneal surface. Many methods were tried for     intraperitoneal application of local anesthetics in laparoscopic surgery such as local     anesthetic (LA) instillation and LA nebulization.      -But these methods are not widely used in pediatrics upon our knowledge   "
95380|NCT02037685|"     Statins are cholesterol lowering medications that reduce the risk of cardiovascular events.     However adherence to these medications has been found to be lower among minorities, a group     particularly vulnerable for heart disease.      The purpose of this study is to compare the efficacy of a phone based behavioral intervention     to mailed educational materials regarding how to control cholesterol and other risk factors.     We hypothesized that the behavioral intervention will improve adherence to statins by 15%.   "
95381|NCT02037672|"     The purpose of this study was to determine whether combined treatment with     phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than     metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome     (PCOS) who had been previously poor responders regarding weight reduction on metformin     monotherapy. The investigators anticipated greater changes in body weight in patients on     combined treatment than in those on monotherapy with metformin.   "
95382|NCT02037659|"     The purpose of having a database is to collect data related to endoscopic ultrasound     procedures performed by Indiana University EUS physicians; specifically, for the treatment of     gastric variceal bleeding This data will be used for research purposes only to determine the     clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The     physicians will also be able to better understand the patient's condition and disease process     that may lead to improved standard of care and improved patient management.   "
95383|NCT02037646|"     The main aim of this study is to determine whether there is a difference in time to diagnosis     of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to     prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT     and appointment-based referral).   "
95384|NCT02037633|"     The purpose of this study is to compare two analgesic methods performed preoperatively to     assist positioning patients for performance of spinal anesthesia, namely fascia iliaca     blockade and intravenous fentanyl.   "
95437|NCT02036944|"     The purpose of this study is to determine if patients with unexplained iron deficiency have     underlying diseases processes such as celiac disease.      It is hypothesized that selectively screening patients with unexplained iron deficiency will     reveal previously undiagnosed etiologies, including celiac disease and other causes of iron     malabsorption along with various sources of occult GI blood loss.   "
95438|NCT02036931|"     The primary purpose of this study is to evaluate the clinical and radiographic performance of     the G7 Acetabular Cup System.   "
95385|NCT02037620|"     In this study, we would like to demonstrate that epidural stimulation can be used to recover     significant levels of autonomic control of the cardiovascular and respiratory function as     well as the ability to voluntarily control leg movements below the injury level. This     intervention would provide an immediate therapeutic alternative to individuals who now have     no recourse for treatment.      Rationale:      We propose to determine the functional gain that can be achieved in voluntary control of     movements below the level of injury and autonomic nervous system function as a result of     activation of spinal circuits with epidural stimulation (ES) in humans with complete motor     paralysis. In addition to the scientific advances, the proposed experiments are essential to     translating this therapeutic approach to a larger scale, which is needed to have a meaningful     clinical impact. ES for recovery of neurological function in patients with severe SCI is not     widely used because of uncertainty regarding the mechanisms of action and convincing evidence     of efficacy in a larger numbers of subjects. Our approach will allow us to determine specific     types of ES needed for voluntary movement and autonomic nervous system dysfunction which lays     the groundwork for expedient translation to larger numbers of individuals with SCI.      Current clinical methods of diagnosis of clinically complete SCI may not be sensitive enough     to detect residual functional synapses across the lesion. We propose to use a series of     neurophysiological approaches that can detect different sources of supraspinal influence on     spinal circuitry and identify specific pathways including vestibulospinal, reticulospinal,     corticospinal and long propriospinal pathways that may remain viable or emerge with ES and     task specific training after complete motor paralysis. Such residual connectivity would be     identified by the presence of voluntarily controlled movement or evoked motor potentials     occurring only in the presence of epidural stimulation. Identifying the essential     supraspinal-spinal pathways needed to recovery these voluntary movements will advance our     knowledge of human neural control of movement and provide critical information for developing     repair and regeneration strategies and in determining the type and severity of patient that     could benefit most readily in regaining voluntary control using epidural stimulation.   "
95386|NCT02037607|"     The purpose of this study is to determine how frequently children undergoing elective     neurosurgical procedures develop blood clots in the deep veins of the legs while     hospitalized. The information gained from this study will help us determine when children     children need to receive therapy to help prevent this type of blood clot from forming.   "
95387|NCT02037594|"     This study identifies social and behavioral factors likely to influence PrEP acceptability     and adherence among men who have sex with men (MSM), and collaborates with a community health     center to evaluate a two-stage intervention to improve PrEP decision-making, as well as     persistence and adherence for those who chose to take PrEP.   "
95388|NCT02037581|"     Improvement of clinical long-term outcome through the implementation of early detection and     intervention within a specialized network of integrated care (ACT and hometreatment) for     adolescents and young adults with a first episode of psychosis between 12 and 29 years.   "
95389|NCT02037568|"     PURPOSE: As this is a randomized controlled trial, all subjects receiving stress management     psychoeducation will be expected to obtain a new set of coping skills that will allow them to     better deal with the stressors of caregiving for an allogeneic HSCT patient. It is expected     that improving caregiver status will improve patient quality of life.   "
95390|NCT02037555|"     This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The     purpose of this study is to determine the safety and effectiveness of human-derived     antithrombin III (AT-III [Human]) supplementation prior to high-risk, non-emergency, cardiac     surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who     meet the study eligibility criteria will be randomized to receive either AT-III (Human) or     placebo.   "
95391|NCT02037542|"     The purpose of this study is to test the hypothesis that an intervention of lifestyle     modification will positively impact women with breast cancer who are overweight and/or obese.     To that end, our primary endpoint is to examine the effects of a practical lifestyle     intervention that can be implemented by overweight or obese women (BMI greater or equal to     25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI     over the course of the study.   "
95392|NCT02037529|"     This is a two arm Phase III trial in first and second-line HER2 negative patients with     locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS),     and the objective is to test for the superiority of eribulin mesylate over standard weekly     paclitaxel. Patients will be randomized between the experimental and control arm with equal     allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status,     and line of therapy. Subjects will continue protocol directed therapy until documentation of     disease progression, development of unacceptable toxicity, or withdrawal of consent. Those     who discontinue study treatment without radiological progression will be followed with repeat     imaging studies every 12 weeks. All subjects will be followed until death, withdrawal of     consent, or study termination.   "
95393|NCT02037516|"     The purpose of this study is to determine if residual weakness after weight loss surgery     leads to an increased risk of respiratory complications in the postoperative period.   "
95394|NCT02037503|"     Suicide attempts are a serious concern worldwide. Currently, existing drugs take about three     weeks to show effect on suicidal thoughts and drives. Recent evidence suggests that     intravenous Ketamine exerts a rapid effect in suicidal patients, even after a single     injection. We aim to examine whether oral Ketamine is a safe and effective treatment in     suicidal patients. Following a suicide attempt, patients will be randomized into a group that     will be given Ketamine for 21 days and one that will receive placebo, and assessed using     questionnaires and brain scans. We expect early improvements in suicide scales in the     Ketamine group.   "
95395|NCT02037490|"     This is a randomized controlled pilot trial of a peer-based, social media intervention to     prevent obesity in infants.   "
95396|NCT02037477|"     The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses     of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls     (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the     CYP2C19 extensive metabolizer (EM) genotype.   "
95397|NCT02037464|"     The purpose of this study is to determine the chemopreventive properties of capsaicin, the     active compound in chili peppers, in prostate cancer patients enrolled in the active     surveillance program or patients scheduled to undergo radical prostatectomy.   "
95439|NCT02036918|"     This study aims to evaluate patients with metastatic castrate-resistant prostate cancer     (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune     activation in lymph nodes and peripheral blood.   "
95440|NCT02036905|"     The objective of this pilot study is to determine the feasibility of a large-scale trial. The     primary objective is to determine if manipulation applied to the cervical and thoracic spines     is more effective than mobilization applied to the cervical and thoracic spines for the     management of patients with mechanical neck pain.   "
95398|NCT02037451|"     Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems     deficit. The clinical symptoms of Parkinson's disease include the following motor tasks:     difficult in initiating movement, performing rhythmic movement or serial movement, the     ability of learning motor movement is also affected. The primary treatment for Parkinson's     disease is medical treatment; surgery is used if in need. Rehabilitation such as physical     therapy, which aims to improve patient's quality of life and functions, is a non-invasive     treatment and value for PD patients. Auditory cue is a technique that widely applied on     training patients with Parkinson's disease, and some researches revealed that auditory cueing     could improve motor performance. However, the mechanism under this treatment technique is     still unknown.      This study is to investigate the effect of auditory cueing on rhythmic finger movement in     patients with Parkinson's disease. To investigate the mechanism under auditory cueing,     neurophysiological data such as motor cortex excitability and blood flow in cortical cortex     will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared     spectroscopy (NIRS).   "
95399|NCT02037438|"     Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART     DOCS) will develop and evaluate a new approach (patient-centered outcomes and     coordinated-care management [PCCM]) for the diagnosis and treatment of sleep disorders.     Specialized and pertinent information and resources regarding sleep disorder management will     be developed and made available through an online portal, allowing patients to make informed     health care decisions, and providers to assist patients in achieving what they feel are the     most important goals regarding their care. Half of participants will be randomized into the     conventional diagnosis and treatment (CONV) arm and the other half into the patient-centered     outcomes and coordinated-care management (PCCM) arm. Validated objective and subjective     assessment measures will be administered at intervals throughout a 13 month participation     period in both the CONV and PCCM arms to determine whether the new PCCM approach for sleep     medicine results in increased patient satisfaction, quality of care, and improved health     outcomes. Qualifying participant will be 18 years of age or older, presenting with a new     sleep disorder. Patients will be enrolled for 13 months and will receive no monetary     compensation.   "
95400|NCT02037425|"     To obtain a patient specific understanding of response to treatment with onabotulinumtoxinA     by collecting and correlating pre and post treatment subject specific history, clinical     outcomes, and histological changes.   "
95401|NCT02037412|"     The investigators hypothesized that ticagrelor may enhance endothelial healing after DES     implantation by increasing adenosine concentrations by the inhibition of adenosine uptake     into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent     of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal     thickness) 3 months after DES implantation by optical coherence tomography (OCT)   "
95402|NCT02037399|"     Besides major ESD-related complications, minor adverse events after ESD are also commonly     noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with     ESD or gastric polypectomy are thought to be associated with transmural burn or transmural     air leak. How control localized pain for patients who suffered from pain after ESD is     appearing as new medical interests. There are few studies about management strategy for pain     after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various     clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy     of glucocorticoids for reducing pain after surgery has recently been investigated.     Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally     reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous     effect through stable serum concentrations. If pain was partially associated with acute     inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD     based on previous studies. we aimed to assess the efficacy of single dose postoperative     intravenous dexamethasone for pain relief after ESD.   "
95403|NCT02037386|"     Intervention for coronary bifurcation lesion is about 10~20% of entire percutaneous coronary     intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at     bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore,     occlusion of side branch frequently occurred during PCI. Several techniques to prevent     occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side     branch stent is developed to treat coronary side branch lesion and composed of proximal,     connecting and distal parts. In vivo study performed in pigs showed effective H-side branch     stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of     coronary side branch lesion.   "
95404|NCT02037373|"     Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in     patients undergoing orthotopic liver transplantation (OLT). The primary objective is to     assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™     versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma     products).   "
95405|NCT02037360|"     The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training     smartphone application on smoking cessation in smokers ages 18 to 65 years.   "
95406|NCT02037347|"     To test the ability of palifermin (a recombinant human keratinocyte growth factor) to     decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis     and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is     extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal     tract, respiratory and genitourinary systems.   "
95407|NCT02037334|"     Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy     will be compared between women with term vs. preterm delivery. We aim to demonstrate that     biomechanical data (ASP and CCI) might complement morphological data (CL) to improve     prediction of preterm delivery. It is expected that women with preterm delivery will show     stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical     consistency index) measurements are performed at mid-pregnancy: detection at this time point     is useful for therapy and biomechanical modifications are already significant so to enable     differentiation by biomechanical measurements (ASP and CCI).   "
95441|NCT02036892|"     Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching +     smartphone-based health promotion software) will have significantly better Hemoglobin A1c     levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the     control arm (health coaching alone).   "
95408|NCT02037321|"     Vegetarian diets have been associated with a reduced risk of preventable diseases such as     type 2 diabetes and cardiovascular disease. These effects may be mediated through direct or     indirect pathways. Although the high intakes of nuts, legumes, dietary fibre, whole grains,     and unsaturated plant oils have each individually been associated with lower risk of type 2     diabetes and cardiovascular disease, so too has the displacement of red meats, processed     meats, and saturated animal fats. One of the most important considerations in moving from     animal-based diets to more plant-based diets is the replacement of animal proteins (e.g.     meat, fish, dairy, eggs) with vegetable proteins (e.g. legumes, nuts, and seeds). It is     unclear whether this particular replacement alone results in advantages for metabolic and     cardiovascular health. To improve evidence-based guidance for dietary guidelines and health     claims development, we propose to conduct a series of systematic reviews and meta-analyses of     the effect of plant-based protein in exchange for animal protein on blood lipids, glycemic     control, blood pressure, body weight, uric acid, markers of non-alcoholic fatty liver disease     (NAFLD), and kidney function and injury. The systematic review process allows the combining     of the results from many small studies in order to arrive at a pooled estimate, similar to a     weighted average, of the true effect. The investigators will be able to explore whether the     effects of replacing animal-based protein for plant-based protein hold true across different     sexes, age groups, and background disease states and whether the effect depends on the     protein source, dose, or background diet. The findings of this proposed knowledge synthesis     will help improve the health of Canadians through informing recommendations for the general     public, as well as those at risk of heart disease and diabetes.   "
95409|NCT02037308|"     The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events,     proposed to be due to reduced nitric oxide production by eNOS reported in some but not all     studies. We hypothesise that beetroot-enriched bread interacts with the Glu298Asp     polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite,     particularly in carriers of the T allele, which have been associated with lower eNOS activity     and increased risk of hypertension.   "
95410|NCT02037295|"     The prevalence of obesity has risen to epidemic proportions in the world, resulting from both     excessive energy intake and low levels of energy expenditure. The effect of nutrient     absorption on energy balance, that is, the relative amount of nutrients consumed vs. the     amount excreted in stool, has been reported only in small studies in which energy waste in     feces and urine between lean and obese individuals was not found to be different. New studies     have shown that bacteria in the gut may play an important role in calorie absorption. We have     recently shown that leaner individuals absorbed more calories when overfed compared to when     they were given a diet with just enough calories to maintain their own weight. Our studies     have also found that overfeeding also changes the kinds of bacteria found in the gut. In lean     individuals, these changes in gut bacterial communities with overfeeding were associated with     changes in how many calories were absorbed. Our results are similar to those seen in other     studies in animals and humans that suggest a role for gut bacteria in weight gain and     obesity. To try to better understand the role of gut bacteria in absorbing food, we propose     to investigate 1) whether energy loss (as measured in stool and urine) changes following     over- and underfeeding relative to body size and 2) whether changes in the gut bacteria,     induced by an antibiotic medication, affect nutrient absorption and glucose tolerance. We     plan to study 24 healthy non-smoking volunteers age 18 45 years old, not taking any     medications (including medications for weight loss, antibiotics or probiotics) for the     examination. All participants will be admitted to the Clinical Research Unit for 31 days.     During their stay, subjects will be fed a weight maintaining diet for 3 days, followed by two     experimental diets (150% and 50% of weight maintaining calories) in a random order. After     this, volunteers will be randomly assigned to one of two groups: group 1 will take oral     antibiotic medication; group 2 will receive pills that look the same but will not contain any     active medication (placebos). Feces (stool) will be collected throughout the study.     Additionally, twenty four-hour urine collections will take place each day of the experimental     diet period and when stool is collected on the antibiotics. The energy content of these waste     products as well as that of the diet (using duplicate plate analysis) will be measured by     bomb calorimetry. Bacterial components in feces will be extracted by repeated fractional     centrifugation to obtain bacterial mass and by using 16S rDNA-based oligonucleotide probes to     obtain data on gut bacteria. Primary results will examine how many calories remain in stool     during relative over- and underfeeding and whether changes in gut bacteria, induced by an     antibiotic medication, affect nutrient absorption and glucose tolerance....   "
95411|NCT02037282|"     Despite currently available antivirals, influenza causes significant morbidity and mortality,     with 226,000 excess hospitalizations and 30,000-50,000 deaths each year in the United States     alone, and more therapies are needed in the armamentarium of anti-influenza medications     including humoral immunity-based agents.      This study will evaluate the pharmacokinetics of an anti-influenza hyperimmune intravenous     immunoglobulin. Beginning with a low dose, subjects will receive anti-influenza intravenous     immunoglobulin (FLU-IVIG) and evaluated on Study Days 0, 3, 7, 14, and 28. The safety and     tolerability is evaluated using symptoms, clinical laboratory tests, and pharmacokinetics.     Utilizing serum antibody responses as determined by hemagglutination inhibition (HAI) assays,     the dose will be escalated as immunogenicity is established.   "
95412|NCT02037269|"     This study is a prospective, cross-sectional observational single centre study to assess the     feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide     local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using     the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a     light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera.     This study will measure the correlation between margin status of the WLE specimen and the     metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System     and by histopathology. This is a pilot study to assess feasibility before proceeding to a     pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical     practice.   "
95413|NCT02037256|"     This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the     combination of bortezomib and G-CSF (filgrastim) in multiple myeloma and non-Hodgkin lymphoma     patients. Giving chemotherapy before a peripheral stem cell transplant stops the growth of     cancer cells by stopping them from dividing or killing them. After treatment, stem cells are     collected from the patient's blood and stored. The stem cells are then returned to the     patient to replace the blood-forming cells that were destroyed by the chemotherapy.   "
95414|NCT02037243|"     An estimated 2.2 million children under the age of 5 years die from diarrheal disease each     year. Most of the burden of diarrheal disease is thought to be preventable with improvements     in sanitation, water quality, and hygiene. Large scale interventions promoting these     behaviours have either not been rigorously tested or have not produced sufficient change to     warrant being rolled out at scale.      Research into the determinants of hand washing behaviour has identified disgust and shame as     key motivators. Evidence supports the theory that disgust is a natural behavioural reaction     to objects carrying disease risk, thus it may act as a key motivator for other health related     behaviours such as water treatment. Whether this knowledge can be harnessed to increase the     efficacy of hand washing and safe water campaigns in Bangladesh or elsewhere has yet to be     rigorously tested.      The investigators will develop an intervention that utilizes disgust and shame eliciting     messages to promote hand washing with soap and point of use water treatment in low income     housing compounds of urban Dhaka. The investigators will test the efficacy of this     intervention against a more traditional public health intervention based on increasing     knowledge of health risks and germ transmission using a randomized controlled trial. The     study sample will be broken into the following four arms.        1. Standard Public Health Intervention with Water Treatment        2. Standard Public Health Intervention with Water Treatment & Hand Washing        3. Disgust and Shame Based Intervention with Water Treatment        4. Disgust and Shame Based Intervention with Water Treatment & Hand      This design will allow us to compare outcomes for hand washing and water treatment between     both standard public health interventions and disgust and shame based interventions as well     as test the overall efficacy of the program comparing with the control. Data will be     collected from all compounds at baseline, three month midline and at the six month endline     giving us the practical and analytical benefits of a longitudinal dataset.      Compounds will participate in interactive, educational safe water and/or hygiene promotion     meetings. For the Disgust and Shame group, these meetings will emphasize disgust and shame     related to unsafe water and/or hygiene practices, whereas the Standard group's meetings will     resemble a more typical public health intervention explaining the risks and methods of     contamination.      At the first meeting, compounds will receive a one month free trial of the latest compound     based chlorine dispenser model to treat their drinking water. A randomly selected half will     also receive a one month free trial of the latest compound based handwashing station. At the     end of the month, there will be a sales meeting in which the investigators will measure     compound members' willingness to pay for the trialled products by giving them the opportunity     purchase and keep the hardware in a Becker-DeGroot-Marschek (BDM) style auction.      In assessing the impact of the interventions, the investigators are primarily interested in     whether the prevalences of safe water and hygiene behaviours differ by treatment arm and over     time. The best measurements for approximating behaviour prevalence are physical observations     (presence of residual chlorine, hand cleanliness inspections), structured observation of     behaviour, rapid physical observations (physical state of hardware/drinking water),     self-report of water treatment and hand washing behaviour and willingness to pay for     necessary products. The investigators will also attempt to measure and track changes in     personal determinants of behaviour such as feelings of disgust and shame related to hand     washing and water treatment behaviours.   "
95415|NCT02037230|"     The investigators' long-term goal is to improve the survival of patients with pancreatic     cancer by enhancing the efficacy of gemcitabine-radiation by adding the Wee1 inhibitor     MK-1775.   "
95436|NCT02036957|"     Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar     erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash,     peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers ,     photosensitivity reactions, swelling of the face and purple) . The impact in patients'     quality of life is great, so We had decided to conduct a randomized clinical trial to     evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient     treated with capecitabine .      Design: Randomized clinical trial phase II, in parallel and double-blind groups      Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will     initiate treatment with capecitabine monotherapy.      Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary     diagnosis, capecitabine monotherapy, sign the informed consent.      Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint     (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by     a logistics regression model   "
95416|NCT02037217|"     A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial     MRI-guided focused ultrasound (MRgFUS) treatment of patients with medication-refractory     movement disorders, namely Essential Tremor (ET).      This study is designed as a prospective, single site, single arm, nonrandomized study.     Assessments will be made before and three months after MRgFUS for clinical symptom relief,     quality of life (QoL) improvements, and safety of MRgFUS in the treatment of ET. Similarly,     QoL measures will be obtained using Quality of Life in Essential Tremor (QUEST)     questionnaire. Relative Safety will be evaluated using a common description of Significant     Clinical Complications for patients treated in this study. This study will be performed on     the 3T MR scanners.      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the     targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion     created in the ventralis intermedius nucleus of the thalamus.      The treatment begins with a series of standard diagnostic MR images to identify the location     and shape of tumor to be treated. The ExAblate computer uses the physician's designation of     the target volume to plan the best way to cover the target volume with small spots called     sonications. These treatment spots are cylinder shaped. Their size depends on sonication     power and duration. During the treatment, a specific MR scan, which can be processed to     identify changes in tissue temperature, provides a thermal map of the treatment volume to     confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,     and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing     1000-element phased array transducer) positioned above the subject head. The ExAblate     transcranial system also includes means to immobilize the subject head, cool the interface     water, and software for CT analysis and phase correction computation.      The ExAblate transcranial system is an experimental device and is being investigated in this     study.   "
95417|NCT02037204|"     Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead     to functional disability and osteoarthritis. Cartilage cell therapy using autologous     chondrocyte implantation (ACI) has been established as the first advanced treatment therapy     medicinal product. Although this technique has achieved good mid-term results, it is a costly     and extensive two-stage procedure which is limited by the number of chondrocytes obtained by     biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a     need for improvement. A new cartilage repair technique should aim at decreasing surgical     trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or     improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and     dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic     phenotype of dedifferentiated articular chondrocytes. In addition, preserving the     pericellular matrix of chondrocytes improves cartilage formation. These chondrons     (chondrocytes with their pericellular matrix) have shown improved cartilage formation when     combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with     fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This     will reduce patient morbidity and improve patient care through immediate transplantation of a     potent cell-based cartilage product. This is a phase I/II prospective monocenter study to     evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage     lesions of the knee.   "
95418|NCT02037191|"     Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult     with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and     efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in     the treatment of severe types of AA.   "
95419|NCT02037178|"     The main objective of this study is to evaluate the inter-observer concordance when measuring     the maximum value of the external antero-posterior diameter of the sub-renal aorta (both     cross-sectional and longitudinal ultrasound views are measured). The first measure is made by     a general practitioner in private practice; second reading are made by an expert in vascular     medicine.   "
95420|NCT02037165|"     -  To investigate the influence of different doses of BI 1026706 on the primary endpoint          (PtP-amplitude LEP in UV skin) compared to placebo.        -  The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.        -  Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin          treatment        -  Exploration of the pharmacokinetics of BI 1026706        -  Exploration of safety and tolerability of BI 1026706   "
95421|NCT02037152|"     The purpose of this study is to test a smartphone-based mindfulness training program for     chronic pain. Research participants use a 20 minute app-guided audio program six days per     week. The study hypothesis is that training in this technique over a period of four weeks     will reduce pain interference with daily life activities. This study does not require any     travel or in-person contact with research staff-- all elements of the study are completed on     the participant's smartphone.   "
95422|NCT02037139|"     Hearing loss screening rates in for older persons in primary care clinics are very low even     though hearing loss is relatively common for older persons. When diagnosed with hearing loss     older persons are often reluctant to follow through. This study involves a prospective     controlled trial comparing the effectiveness of three primary care based protocols for older     adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to     and use of hearing health care services. The protocols will compare: 1) screening only     (standard care control); 2) screening plus an illustrated educational brochure; and 3)     screening plus an in-person educational intervention and an illustrated educational brochure.     Screening will be done by primary care personnel. Participants will be tracked for 8 months     to assess outcomes.   "
95423|NCT02037126|"     The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of     psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of     psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine     involvement (e.g., criminal involvement).      MRI assessment is a unique aspect of this study. As a potential biological mechanism of     psilocybin's effect includes changes in default mode network functional connectivity     (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are     mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate)     abnormalities have been shown to play a role in cocaine addiction, we will determine if     psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.   "
95459|NCT02036658|"     The purpose of the study is to investigate the immediate and longer-term impact of     Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR)     for patients with Social Anxiety Disorder.   "
95460|NCT02036645|"     The purpose of this study is to assess the safety, drug levels and effects on the body of 1     or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy     elderly people.   "
95488|NCT02036268|"     This is a randomized study of standard versus extra ostomy education.   "
95424|NCT02037113|"     This is a prospective, single-center study. The patients with peripheral arterial disease who     underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal     aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be     enrolled in the study. All patients who participated in the study will be treated according     to standard of care.      HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on     peripheral artery intervention.      SPECIFIC AIMS        1. To determine intravascular ultrasound parameters of stent deployment and outcomes of          Femoro-popliteal Disease        2. To determine clinical risk factors and outcomes of Femoro-popliteal Disease        3. To obtain data that will eventually support development of a predictive model for ISR in          Femoro-popliteal Disease      METHODOLOGY Visit 1: After consent is given      The subject will receive standard follow-up care. A member of the research team will collect     information such as the subject's age, sex, ethnicity, and medical information from the     subject's medical record.      Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+-     2 weeks)      The subject will complete standard follow-up appointment at TTUHSC. This may include a     Doppler ultrasound.      A member of the research team will record information such as medications, ultrasounds, and     need for additional care related to the subject's stent.      The subject will complete the questionnaire on leg pain and mobility.   "
95425|NCT02037100|"     SDB has been identified as an important risk factor for insulin resistance and the metabolic     syndrome.      In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to     improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c).      In children, there are only 3 studies that have examined the relations between SDB, obesity     and the metabolic syndrome.      In order to further understand the relative contribution of SDB to the development of     impaired glucose homeostasis and metabolic abnormalities we aim to investigate the prevalence     and severity of SDB in children with T2DM compared to obese children without T2DM. The     investigators hypothesize that SDB will be more prevalent and more severe among obese     children with T2DM compared with the general obese pediatric population.   "
95426|NCT02037087|"     It is hypothesized that delivering short messages (SMS) to pregnant women can improve     maternal and newborn health outcomes. This pilot offers mothers-to-be in rural China free     daily short messages (SMS) via cell phone. The aim is to advise them on (a) good household     prenatal practices (GHPP) and (b) care seeking (CS) in order to improve the quality of life     for mothers and newborns.   "
95427|NCT02037074|"     This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral     dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308     administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic     regimen.   "
95428|NCT02037061|"     This is a randomized controlled trial to determine if intraoperative local analgesia     administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by     patients postoperatively after SSL colpopexy.      Hypothesis: Local analgesia administered at the level of the sacrospinous ligament can lessen     the gluteal pain felt by patients postoperatively after SSL colpopexy.   "
95429|NCT02037048|"     This phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil     followed by surgery and response based concurrent chemotherapy and radiation therapy works in     treating patients with cancer of the esophagus, gastroesophageal junction, or gastric cardia.     Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil,     paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x     rays to kill tumor cells. Giving chemotherapy followed by surgery and response based     chemotherapy and radiation therapy may kill more tumor cells.   "
95430|NCT02037035|"     This study is looking at the mechanisms underlying the behavioral effects of ketamine in     healthy and depressed individuals.   "
95431|NCT02037022|"     This is a research study examining the effectiveness of a pivotal response treatment package     (PRT-P) in targeting language skills in young children with autism.   "
95432|NCT02037009|"     In France, cataract surgery is the most frequent surgical procedure, performed with local     anesthesia and most often very light techniques using eye-drops. Technical improvements of     surgical and anesthesic procedures have led many countries to implement alternative     surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic     surveillance (doctors or nurses) should be qualified in anesthesia.      In this study, the investigators aim to assess the feasibility and safety of a centralised     monitoring station outside of the operating rooms, as an alternative to the presence of 1     anesthetic nurse in each operating room.   "
95433|NCT02036996|"     The objective of this study is to collect heart rate, respiration data and motion data of     patients admitted to sleep lab and to determine the current accuracy level of the EarlySense     system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab     in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter)     that are currently used in the sleep lab among different population (Obese, patients with or     without apnea, patients with or without arrhythmia). It is emphasized that no interpretations     or clinical decisions will be made based on data received from the ES study device.   "
95434|NCT02036983|"     Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with     dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under     direct visualization will be compared it to a standard anesthetic technique (control)     following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are     hypothesizing that the bilateral TAP block and preperitoneal instillation of local     anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction     and post-operative pain control when compared to a standard anesthetic technique (no regional     technique).   "
95435|NCT02036970|"     This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in     patients with pulmonary hypertension to determine the recommended dose range, evaluate the     change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone     methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung     disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO     Group V PH following 16 weeks of study participation.   "
95442|NCT02036879|"     The objective of this study is to investigate the impact of hormones on lung disease in     Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and     healthier lives than they did 20 years ago. However, females have been shown to have a     survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The     hypothesis is that estrogen and/or progesterone negatively impact lung health in CF.     Therefore, understanding the impact of sex hormones (including the use of birth control     pills) on the disease process is increasingly important. The purpose of this study is to     determine if lung function, respiratory symptoms, or various markers of lung health change     during different phases of the natural ovulatory cycle in order to understand if estrogen or     progesterone hormones are impacting the disease relative to fluctuations in men with stable     testosterone levels. The research objectives of this project are to:        -  Determine if lung function, respiratory symptoms, or various markers of lung health          change during different hormonal phases of the ovulatory cycle in women.        -  Determine if men change lung function, respiratory symptoms, or various markers of lung          health over time.        -  Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and          improve lung health.   "
95443|NCT02036866|"     To determine differences in thigh muscle function in individuals with and without knee     arthritis, and also determine the effectiveness of common physical therapy interventions on     clinical and patient oriented outcomes.   "
95444|NCT02036853|"     This study is being done to assess the safety and long-term efficacy of triheptanoin in     patients with Glut1 DS over a 4-year treatment period. Glut 1 is a protein that helps     transport glucose to the brain. Glucose is the brain's primary source of energy. Glut 1 DS     prevents this protein from being effectively produced causing starvation of the brain.      This study is being done to assess the safety and long-term efficacy of triheptanoin in     pediatric patients with Glut1 DS over a 4-year treatment period. Glut 1 is a protein that     helps transport glucose to the brain. Glucose is the brain's primary source of energy. Glut 1     DS prevents this protein from being effectively produced, causing deprivation of energy to     the neurons of the of the brain.      Glut1 DS is a severely debilitating disease characterized by seizures, developmental delay     and movement disorder. There are currently no approved treatments specific to Glut1 DS.     Treatment generally includes medications for control of seizures. The use of a ketogenic diet     can be effective in controlling seizures when medications are ineffective or provide     insufficient control. However, the ketogenic diet may be very difficult for patients to     maintain for long periods of time, and there may be negative secondary long-term effects of     ketogenic diet.. Triheptanoin is metabolized to molecules that can provide an alternative     energy source to the brain, and appears to help in controlling seizures without many of the     difficulties of the ketogenic diet.      Eligible patients may be those who have been diagnosed with GLUT1 DS, and have discontinued     or are not currently on ketogenic diet, or are able to tolerate triheptanoin if they have     been treated or are currently being treated with triheptanoin and do not qualify for any     other clinical trial.   "
95445|NCT02036840|"     The proposed research project will retrospectively review the anesthetic records over the     past 5 years and identify patients who present with a history of penicillin allergy or     allergy to an antibiotic in the penicillin family. The reason for that history and the facts     on which that allergy are noted will be determined. Additionally, the choice of antibiotic     prophylaxis will be recorded and any adverse effect to that antibiotic noted. We will also     note whether appropriate timing of the antibiotic is achieved.   "
95446|NCT02036827|"     The purpose of this study was to investigate whether there is any difference in incidence of     shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate     neuromuscular block and deep neuromuscular block.   "
95663|NCT02033980|"     Recently, a new category classification (NICE classification) using non-magnified NBI has     been proposed. We design this multicenter study to evaluate the reliability and validity of     the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both     image and real-time process.   "
95447|NCT02036814|"     The aim was to test if interpersonal relationships group strategies provided by nursing can     promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in     hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A     10 patients (8 women), underwent to a health educational orientation program     (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings).     Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days     during 4 months (3 meetings). Both groups received the same content guidelines (healthy     lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline     (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL     questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30     days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120     days.   "
95448|NCT02036801|"     Aim of this study is to assess lung specific elastance in a population of pediatric patients     with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a     pediatric population of ICU patients with healthy lung which are treated with mechanical     ventilation for other clinical purposes.   "
95449|NCT02036788|"     Esophageal pressure measurement, obtained with the use of an esophageal balloon catheter, is     fundamental to assess mechanical characteristics of the respiratory system during mechanical     ventilation. The correct positioning of the catheter (usually at the medium third of the     esophagus) is crucial for an accurate measurement of esophageal pressure. Usually the correct     positioning of the catheter is verified with an occlusion test (If the patient is breathing     spontaneously) or with thoraco-abdominal compressions (if the patient is sedated and     paralyzed). Aim of this study is to compare the accuracy of these two methods at different     PEEP and esophageal catheter positions.   "
95450|NCT02036775|"     To characterise pharmacokinetics and assess the relative bioavailability of two new oral     formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and     Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg   "
95451|NCT02036762|"     THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE     PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND     SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE   "
95452|NCT02036749|"     The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael     Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local     anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized,     controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after     cesarean delivery will be compared with a placebo control group of 20 patients to investigate     analgesic consumption, pain level, opioid related side effects and mobilization.   "
95453|NCT02036736|"     The recovery of cognitive and psychomotor functions is best performed under anesthesia after     desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.      The principal objective is to compare the cognitive and psychomotor status of patients     recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)     using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory     (visual verbal learning test) made SSPI.   "
95454|NCT02036723|"     GALATIR is a double blind randomized clinical trial comparing efficacy and safety of BCD-021     (bevacizumab) and Lucentis® (ranibizumab) in patients with neovascular wet age-related     macular degeneration. The purpose of the study is to demonstrate the non-inferiority of     efficacy and safety of BCD-021 compared to Lucentis®.   "
95455|NCT02036710|"     Background: Physicians do not have a unified, scientifically tested theory of causation for     obesity and its comorbidities, nor do they have explanations for the mechanics of the     metabolic/bariatric surgery procedures. Integral to proffered hypotheses are the actions of     the hormones glucagon-like peptide (GLP-1), peptide YY (PYY), and leptin.      Study objective: To obtain blood levels of GLP-1, PYY, and leptin after stimulation of the     terminal ileum and cecum by a static infusion of a food hydrolysate in morbidly obese     patients undergoing a duodenal switch procedure.      Methods: Plasma levels of GLP-1, PYY, and leptin were obtained at 0, 30, 60, 90, and 120     minutes after instillation of 240 ml of a food hydrolysate into the ileum or cecum.   "
95456|NCT02036697|"     We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central     venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a     higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of     hypotension, and compare pain control and maternal satisfaction during and after cesarean     section.      We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia     for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster     recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by     self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to     interact with baby in the OR.   "
95457|NCT02036684|"     Radical prostatectomy is the most common and effective treatment for localized prostate     cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects,     such as urinary incontinence, sexual dysfunction, and reduced physical function that     collectively diminish health-related quality of life which may persist for up to two years     postoperatively. The primary objective of this trial is to assess the feasibility of     conducting of a multi-site randomized controlled trial to test the effect of a comprehensive     prehabilitation program versus standard care for men with prostate cancer undergoing radical     prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy     in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle     exercises) will report better health-related quality of life, urological symptoms, and     physical fitness, physical activity, and pain, as well as a shorter postoperative length of     stay than participants receiving standard preoperative care (pelvic floor muscle exercises     alone). Our secondary objective is to report estimates of efficacy on several clinically     important outcomes for this population that will be used for sample size calculations in an     adequately powered trial.   "
95458|NCT02036671|"     The objective of this study is to evaluate the safety and efficacy of the FLEX System when     used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with     Chronic Kidney Disease (CKD) who require hemodialysis vascular access.   "
95461|NCT02036632|"     First, this study will investigate the viability of 24-hour eye patching as a potential     treatment modality for CSR. Second, this study will assess a potential physiologic     explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will     aid in ameliorating disease severity and disease duration.   "
95462|NCT02036619|"     The General hypothesis is that the IADPSG screening strategy for gestational diabetes (GDM)     will lead to an important increase in the work load and the prevalence of GDM in Belgium but     that this might not be cost effective concerning the prevention of adverse pregnancy     outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for     women diagnosed with the two-step screening strategy.      In this prospective multicentric cohort study, women will be universally screened for     pregestational diabetes and GDM at the first prenatal visit during the first trimester by     measuring the fasting plasma glucose. In the second trimester, women without diagnosis of     diabetes or GDM in the first trimester, will be universally screened for GDM using the 50g     glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT) with the IADPSG     criteria for GDM. Diagnosis of GDM will be based on the 75g OGTT.   "
95463|NCT02036606|"     Racing thoughts relate to subjective acceleration of thinking which has been essentially     associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of     racing thoughts in major depression seems to differ from rumination and pure manic racing     thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative evidence     is consistent with the existence of these two kinds of thought overactivity related to mood     disorders. In order to evaluate this and better understand the psychopathological and     cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a     34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a     number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the     relationship between mood disorders and creativity, it is likely that thought overactivity is     related to increased creativity. We aim at evaluating this relationship through the French     version of the Cognitive Processes Associated with Creativity scale (CPAC).   "
100217|NCT01974375|"     The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100     mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to     the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.   "
95464|NCT02036593|"     The Specific Aims for CATCH: PATH are:      Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a     multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase     opportunities for active living, specifically walking groups, in three communities in     Detroit.      Specific Aim 2: To promote cardiovascular health through implementation and evaluation of a     multilevel CBPR intervention (i.e., organization, community, policy levels) to promote     leadership development, community action, and policy level change to enhance neighborhood     environments that support and sustain active living.      Specific Aim 3: To maintain and evaluate the HEP CBPR partnership engaging members of the     partnership in providing scientific and community oversight for all aspects of the CATCH:     PATH project.      Specific Aim 4: To disseminate preliminary results and develop a comprehensive Dissemination     Plan to share research findings through community and peer reviewed outlets to assure     translation of results from this multilevel CBPR intervention into programmatic and policy     efforts to improve heart health in eastside, northwest and southwest Detroit.   "
95465|NCT02036580|"     The purpose of the study is to evaluate the safety and tolerability of multiple-doses of     tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.   "
95466|NCT02036567|"     This longitudinal observational study will attempt to objectively measure pain with an     experimental, non-invasive device. Patients and volunteers will receive a baseline screening     with psychophysical tests and questionnaires. Investigators will apply the device to measure     pain during routine clinical care and correlate patients pain ratings and analgesia     requirements to that measured by the device. A more standardized approach with experimental     pain stimuli will be pursued in human volunteer studies.   "
95467|NCT02036554|"     To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in     comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset     Diabetes Mellitus after transplantation in the renal allograft recipients   "
95468|NCT02036541|"     To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with     refractory glaucoma.   "
95469|NCT02036528|"     The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus     oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to     moderately infected foot ulcers in diabetic patients.   "
95470|NCT02036515|"     This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment     of participants with type 2 diabetes mellitus who have inadequate glycemic control on     metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C     (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo     with an underlying hypothesis that addition of treatment with ertugliflozin provides greater     reduction in A1C compared with the addition of placebo; the primary objective will be tested     for both 5-mg and 15-mg doses of ertugliflozin.   "
95471|NCT02036502|"     This is a study of pembrolizumab (MK-3475) in combination with lenalidomide and low-dose     dexamethasone in participants with refractory or relapsed and refractory Multiple Myeloma     (rrMM), and in combination with carfilzomib and low-dose dexamethasone in participants with     relapsed or refractory Multiple Myeloma (rMM).      This study is being done to find the maximum tolerated dose (MTD)/maximum administered dose     (MAD) and recommended Phase 2 dose (RP2D), and to evaluate the safety and tolerability of     pembrolizumab when given in combination with standard of care (SOC) treatments in     participants with rrMM or rMM. Preliminary efficacy data will also be assessed. The primary     study hypothesis is that these combinations are sufficiently well tolerated to permit further     clinical investigation.   "
95472|NCT02036489|"     Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL     treated with a pediatric protocol.   "
95473|NCT02036476|"     This is an open-label, non-randomized, phase 2 study to assess the feasibility of using     cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after     platinum-based therapy.   "
95541|NCT02035579|"     Sports-related concussions are common in adolescent-athletes. Prolonged recovery after     concussion or post-concussion syndrome (PCS) is a public health problem. This project will     determine the effectiveness of an aerobic exercise program for management of PCS and it will     evaluate the influence of exercise on biologic correlates of PCS.   "
95474|NCT02036463|"     Duchenne muscular dystrophy (DMD) is a progressive neuromuscular disease for which no     curative treatment has yet been identified, making it important to slow progression and     improve the quality of life among affected boys and young men. Treatment with corticosteroids     is standard of care for patients with DMD five years old and older, due to the robust     observation that this intervention lengthens the interval prior to loss of ambulation but is     associated with many side effects. This clinical trial will be conducted in the youngest age     group able to receive corticosteroids orally and on whom study outcomes are measurable, ages     3 to 7 years. This is a randomized, double blinded, double masked, placebo-controlled     clinical trial that will explore whether better synchronization of corticosteroid     administration with the circadian rhythm will provide improved tolerability and at least     comparable efficacy to current standards in which corticosteroids are always given in the     morning. Furthermore, the trial provides a unique opportunity to rigorously evaluate     corticosteroid effects in the young DMD patient, both for efficacy as compared to placebo and     as a study of the impact of corticosteroid chronotherapy, or delayed release, on increased     tolerability over standard therapy. The main hypothesis is that synchronization of the timing     of corticosteroid dosing will improve medication tolerability in children, while maintaining     (non-inferiority) the efficacy of corticosteroid. The study also offers a unique opportunity     to measure several biomarkers as well as novel genetic modifiers that may further impact the     response to corticosteroid in DMD.   "
95489|NCT02036255|"     The objective of our study is to investigate whether the substitution of the standard locking     solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U     25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis     patients with a history of TCC dysfunction requiring urokinase therapy.   "
95874|NCT02031224|"     This is a prospective single center randomized controlled trial with a total duration of 18     months aiming to evaluate the effectiveness and the safety of a very low protein diet     supplemented with ketoanalogues of essential aminoacids in reducing the progression of     chronic kidney disease (CKD) in patients with advanced CKD.   "
95475|NCT02036450|"     The LOOP study aims to clarify whether stroke and peripheral emboli can be prevented by     monitoring the heart rhythm with a small device (called a loop recorder). The recorder which     is placed under the skin on the front of the chest wall allows monitoring of the heart rhythm     24-hours a day 7 days a week.      The study has 6,000 participants with risk factors for stroke (age >70 years, and at least     one of the diseases: diabetes, hypertension, heart failure or previous stroke) but without a     history of atrial fibrillation, of which 1,500 will have a loop recorder implanted and 4,500     will be included in a control group. Participants are randomised to receive a loop recorder     or not (control).      If a participant has atrial fibrillation of more than 6 min duration the study participant     will start oral anticoagulation therapy according to local guidelines.   "
95476|NCT02036437|"     To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone     for labor induction.   "
95477|NCT02036424|"     To determine if there is visual benefit with Ozurdex treatment every three months compared to     monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator     hypothesizes more frequent administration of Ozurdex in patients that have persistent     diabetic macular edema will result in a more rapid and sustained improvement of visual acuity     and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.   "
95478|NCT02036411|"     100mg clomiphene citrate used for ovulation induction. The investigators take blood sample at     3 and 10 days of menstruation and count AMH and inhibin B.   "
95479|NCT02036398|"     Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL)     with nephrostomy placement and double J stent and PCNL with double J placement only without     nephrostomy.   "
95480|NCT02036372|"     The incidence of diabetes mellitus type II is increasing. More and more patients who need     surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering     protocols and the proven negative effects of hyperglycaemia. There is no evidence for the     optimal glucose lowering protocol.      This study investigates the optimal intraoperative treatment algorithm to lower glucose in     patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing     intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1     (liraglutide, LG) treatment.   "
95481|NCT02036359|"     To compare clinical response (complete response and partial response) by RECIST) rates by     RECIST between erlotinib monotherapy and docetaxel plus cisplatin chemotherapy   "
95482|NCT02036346|"     One of the main reasons for hospital readmission in ileostomy patients is fluid and     electrolyte abnormalities. Prospective observational studies have suggested an occurrence     rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium     and fluid through their stoma effluent. In addition studies have shown that ileostomy     construction is a risk factor for renal impairment, occurring secondary to dehydration.      Encouraging patients to increase total fluid intake seems to be a common mistake in clinical     practice as this can dilute sodium levels even more, causing greater sodium depletion. In     terms of addressing the problem a few small studies have used isotonic drinks of various     compositions showing increased electrolyte absorption.      Other dietary complications sometimes include hypomagnesaemia and decreased absorption of     B-12 and folic acid, however due to the integrity of the small intestine other nutrient     malabsorption is unlikely to occur. As far as body composition is concerned obesity has been     shown to be a risk factor for peri- and postoperative complications in colorectal surgery     (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining     measures that can prevent readmission for dehydration and other nutritional considerations     related to this group of patients is definitely required.      Hypothesis:      The administration of an oral rehydration solution will allow a significant decrease in     dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.   "
95483|NCT02036333|"     The purpose of this study is to determine whether there is a difference in cerebral     oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and     healthy controls.   "
95484|NCT02036320|"     The purpose of this clinical trial is to compare the overall lens fit acceptance of two     different soft contact lenses in an Asian population.   "
95485|NCT02036307|"     This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the     other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood     pressure, and fasting triglyceride levels.   "
95540|NCT02035592|"     The purpose of this study is to determine the dose-dependent impact of 6 month freeze-dried     blueberry powder intake on insulin sensitivity and resistance, cardiovascular disease risk     factors, and lung and cognitive function in overweight and obese participants with metabolic     syndrome. We will also examine acute post-prandial effects of blueberry intake (at baseline     and at 6-months).   "
95486|NCT02036294|"     This study involves development and testing of a patient and family-centered transitional     care program for patients who are hospitalized with Chronic Obstructive Pulmonary Disease     (COPD) exacerbations. The study intervention includes tailored services to address individual     patients' biopsychosocial needs, starting early during hospital stay and continuing for 3     months post hospital discharge.      The study hypothesis is that compared to usual care, the study intervention will : a) Improve     patient health- related quality of life and survival, and reduce use of hospital and     emergency room visits; b) result in improved patient experience, self- confidence, and     self-care behaviors; c) result in improved family caregivers coping skills, self-confidence,     and problem solving skills to address patient barriers to care and treatment.   "
95487|NCT02036281|"     The subjects will be treated with a single dose of SP-SAP. They will receive the study drug     SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and     required to stay in the hospital for 24 hours for precautionary care. Their vital signs will     be monitored and recorded immediately following the injection. After the catheter has been     removed, the following assessments will be made physical exam including motor and sensory     functions, and electrocardiogram. A neurologist will be available for consultation as needed.      Beginning dose of SP-SAP will be 1 -mcg for the first cohort.      Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into     the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities     between cohorts.      Study duration will be up to 6 months from the start of SP-SAP administration.   "
95490|NCT02036242|"     It is common for obstetric anesthesia using opioid supplement to local anesthetics for     epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the     necessity of the supplement of opioid to lacal anesthetics during this process based on the     concept that opioid addition can enhance and prolong the analgesic effect of local     anesthetics. However, we unavoidably encounter many opioid-associated side effects during the     labor delivery. In addition, usage of opioid increase the medical cost for each patient. We     herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can     produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor     pain control.   "
95491|NCT02036229|"     The purpose of this study is to determine whether 0.5% ivermectin cream is effective in the     treatment of demodicidosis (including papulopustular rosacea)   "
95492|NCT02036216|"     Circulating free cell DNA (cfDNA) is extracellular fragmentation of nucleic acids that occurs     both in plasma and serum. This kind of DNA which derived from the apoptotic/necrotic cells or     the lysis of circulating tumor cells (CTCs) can be detectedin the patients with a variety of     diseases. Emerging evidence suggests that cfDNA from patients exhibits characteristicchanges     of tumors, suchas mutations, insertions/deletions, methylations,microsatellite aberrations,     and copy number variations, etc. All of these reveal a visible difference between the benign     conditions, and thus may be useful in the diagnosis of cancer, identification of targeted     therapy, monitor responses to treatments, and early detection of relapse. The purpose for     this study is to explore these characteristic changes in the patients withhepatocellular     carcinoma (HCC) and expect to guide targeted therapy and identify non-invasive biomarkers of     cancer diagnosis and prognosis which can be easily isolated from the circulation.   "
95493|NCT02036203|"     This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD     compared to the standard T shaped copper IUD, the TCu380.      Participants will be followed for one year and quality of life measurements will be measured     during this period as well.   "
95494|NCT02036190|"     The long-term objectives of this ancillary application are to characterize a subpopulation of     smokers with auto-reactive T cell response, to validate immunodiagnostic assays that could     detect emphysema, and to find molecular signatures for pathogenic T cell development in a     well-characterized cohort participating in SPIROMICS (UCSF center).   "
95496|NCT02036164|"     Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation     (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We     will investigate if ACT has survival benefit over CCRT alone.   "
95497|NCT02036151|"     The study was designed to determine whether maternal xylitol consumption through regular     chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and     dental plaque levels of their children.   "
95517|NCT02035891|"     The study aims to assess：        1. whether low-dose colchicine could reduce microalbuminuria in patients with type 2          diabetes and microalbuminuria who have been receiving stable treatment of          angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACEI/ARB) for          at least 3 months;        2. whether low-dose colchicine decreases carotid intima-media thickness(IMT) in patients          with type 2 diabetes and microalbuminuria;        3. whether low-dose colchicine slows the progression of microvascular complications in          patients with type 2 diabetes and microalbuminuria;        4. whether low-dose colchicine reduces the risk of cardiovascular events in patients with          type 2 diabetes and microalbuminuria.   "
95498|NCT02036138|"     The growing incidence of obesity and type2 DM globally is widely recognized as one of the     most challenging contemporary threats to public health. Uncontrolled diabetes leads to     macrovascular and microvascular complications, including myocardial infarction, stroke,     blindness, neuropathy, and renal failure in many patients. The current goal of medical     treatment is to halt disease progression by reducing hyperglycemia, hypertension,     dyslipidemia, and other cardiovascular risk factors. Despite improvements in pharmacotherapy,     fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and     maintain therapeutic thresholds, particularly for glycemic control. Observational studies     have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and     cardiovascular risk factors in severely obese patients with type 2 diabetes Few randomized,     controlled trials have compared bariatric surgery with intensive medical therapy,     particularly in moderately obese patients (defined as those having a BMI of 30 to 34.9) with     type2 DM. Accordingly, many unanswered questions remain regarding the relative efficacy of     bariatric surgery in patients with uncontrolled diabetes. This randomized, controlled,     prospective multicenter study was designed to compare intensive medical therapy with surgical     treatment (LRYGB or LSG) as a means of improving glycemic control in moderately obese     patients (BMI 30-34.9) with type- 2 DM.   "
95499|NCT02036125|"     The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid     injection in reducing symptoms caused by carpal tunnel syndrome.   "
95500|NCT02036112|"     An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision     (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE     versus Individual ELAPE.   "
95501|NCT02036099|"     Based on the literature on dementia and driving, and on knowledge tools available to date     including one from our current work, a Driving in Mild Dementia Decision Tool (DMD-DT) will     be adapted and tailored to guide physicians in their decisions to report a driver with mild     dementia to the provincial licensing agency. The DMD-DT intervention will include a) an     algorithm-based computerized clinical decision support system (CCDSS) for facilitating     driving assessment and physicians' reporting to provincial transportation authorities, b) an     individualized educational package for patients and caregivers about dementia and driving and     driving cessation, and c) a modified reporting form to provincial driving regulatory     authorities. Months 1 to 6: The DMD-DT will be tailored and adapted to practice with the     input of the co-investigators and knowledge-users who represent the perspectives of     physicians, patients and their caregivers, as well as transportation authorities. Pilot     testing will be done, and input from focus groups of knowledge-users will refine the     intervention. Physicians will be recruited to participate in a clinical trial of the DMD-DT.     Months 7-18: A parallel-group cluster randomized controlled trial (RCT) will be conducted to     compare the effects of the DMD-DT to a legislation reminder on recommendations for reporting     to the licensing agency. The effects of the DMD-DT on the doctor-patient relationship will be     further explored in focus groups and interviews with physicians. Months 19-24: The knowledge     obtained from the study will be used to generalize and sustain use of the intervention beyond     Ontario, Canada, and to disseminate the information to knowledge-users. The primary outcome     measure is the filing of a report to the Ministry of Transportation of Ontario, indicating     that the physician has a concern about the patient's health condition (i.e. mild dementia).     The primary outcome of the study is the difference in reporting between the DMD-DT and     control arms. Since the current reporting rate is low, approximately 13%, from a public     health point of view, the primary outcome expected is that physicians in the DMD-DT group     will report more patients with mild dementia than those in the control group.   "
95502|NCT02036086|"     This study will evaluate the clinical and pathological response to vemurafenib and     cobimetinib in the neoadjuvant treatment of patients with histologically confirmed, BRAF V600     mutation-positive Stage IIIB and C melanoma. 20 patients will be treated with vemurafenib and     cobimetinib for 2 months. Then they will be assessed for surgery. Patients will undergo     surgery and subsequently resume taking vemurafenib and cobimetinib after recovery from     surgery. Patients will undergo radiation therapy if appropriate then continue vemurafenib and     cobimetinib. The maximum treatment period is 12 months. After 12 months of treatment,     patients will be followed for disease recurrence and survival during for a total of 5 years.   "
95503|NCT02036073|"     EPO has been safely used for prevent preterm anemia and recent studies have shown the     neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The     aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg     higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on     neurodevelopment in preterm infants; to detect biological indicators and explore the     neuroprotective mechanism of EPO.   "
95504|NCT02036060|"     Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading     cause of men cancer death in the United States. Hormonal therapy remains a first-line     treatment for metastatic prostate cancer. Initial responses to hormonal therapy with chemical     or surgical castration are quite favorable, however, most patients will progress to a     castration-resistant phase of the disease. Docetaxel is the primary chemotherapeutic option     for patients with mCRPC.      Abiraterone is a novel, selective, irreversible, and potent inhibitor of     17-[alpha]-hydroxylase/17,20-lyase (CYP17) enzymatic activity that has recently been     demonstrated to further reduce testosterone levels in the blood to undetectable range (< 1     ng/dL) and is suggested to reduce de novo intratumor androgen synthesis. Abiraterone     demonstrated activity in castration resistant prostate cancer patients previously treated     with docetaxel chemotherapy. Recently, results of a phase III trial comparing abiraterone     plus prednisone vs placebo plus prednisone in asymptomatic and without visceral metastasis,     castration-resistant metastatic prostate cancer patients, demonstrated a better radiological     progression free survival for abiraterone treated patients and a trend towards a better     survival was clear for abiraterone treated patients.      No clinical evidence exists about efficacy of chemotherapy and antiandrogen therapy     combination. All trials have been performed in patients in which LHRH agonist treatment was     continued although there is not clear evidence about efficacy of hormonal treatment. Some     retrospective studies suggest that androgen deprivation treatment should be maintained in     chemotherapy treated patients. Abiraterone has been proved to suppress androgen levels to     negative values, and to add efficacy to castration hormonal therapy. Combination of     abiraterone with docetaxel chemotherapy seems promising adding efficacy to only docetaxel     chemotherapy. A randomized phase II study comparing docetaxel + prednisone + abiraterone to     docetaxel + prednisone in mCRPC in patients treated previously with abiraterone, seems     promising to explore addition of efficacy to taxotere after abiraterone hormonal treatment.   "
95505|NCT02036047|"     The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal     polyps, resulting in an increase in the complete resection rate and a decrease in the adverse     events.   "
95506|NCT02036034|"     The investigators hypothesize that this modified ophthalmic draping will reduce the     accumulation and rebreathing of carbon dioxide during eye surgery.   "
95518|NCT02035878|"     The proposed project will investigate the effects of probiotics on anxiety and associated     psychological and physiological factors in humans. The therapeutic potential of probiotics     for reducing anxiety and other factors associated with a disrupted microbiome will be     assessed in a double-blind placebo-crossover design. Based on the research findings to date,     it is hypothesized that probiotics will reduce anxiety and depressive symptoms.   "
95519|NCT02035865|"     The investigators aim at characterizing neuropsychiatric consequences of heart     transplantation (HTX) and at assessing the impact of depressive symptoms after HTX on     mortality and cardiac allograft vasculopathy (CAV).   "
95520|NCT02035852|"     The study will compare two different size MRI's of a brain tumor.   "
95521|NCT02035839|"     To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3     different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.   "
95507|NCT02036021|"     Mortality related with cardiac arrest in anesthetized children has diminished over several     decades from 2.9 per 10000 anesthesias in 1961 to 0.21 per 10000 anesthesias in 2007.(1) Even     though the mortality rate related to pediatric anesthesia is much lower than before,     respiratory complications related with peri-operative cardiac arrest are as high as 27%     according to the Pediatric Peri-operative Cardiac Arrest (POCA) Registry.(2).Therefore,     peri-operative respiratory event (PRE) in pediatric anesthesia such as laryngospasm, stridor,     bronchospasm, desaturation and reintubation are crucial.      Stridor and reintubation occur after the children are extubated, mostly in the PACU period.     Laryngospasm, stridor, bronchospasm and wheezing can lead to desaturation and the need for     reintubation. Those PRE, especially peri-operative desaturation, can prolong PACU stay     especially if PRE develops in the PACU.(8,9) PRE occurring during the intraoperative period     can also prolong PACU stay if children are observed at PACU and not transferred directly to     the intensive care unit (ICU). Some children require oxygen therapy in the PACU and continue     at the ward. Some need endotracheal tube intubation with spontaneous breathing or are placed     on mechanical ventilator. Thai AIMS (10) reported that desaturation at PACU was associated     with re-intubation, prolonged mechanical ventilation and unplanned ICU admission. Oxygen     supplement need, prolonged mechanical ventilation or unplanned ICU admission can produce     extra days of hospitalization or increase the cost of hospitalization from extra-cost payment     eg; oxygen therapy, mechanical ventilator, cost of ICU stayed.      Furthermore, the short-term sequelae regarding cost of hospitalization of children who     develop PRE has never been evaluated or compared with the cost in children who do not develop     PRE. Higher cost of hospitalization after occurrence of PRE in anesthetized children will     have an impact to the hospital policy maker. Minimizing PRE can save on the cost of hospital     care to the public hospital or other health sectors.      Therefore, we would like to compare days of hospitalization and cost differences of     hospitalization between children who develop PRE and children who do not develop PRE at a     tertiary care hospital in southern Thailand   "
95508|NCT02036008|"     The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a     useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver     metastases compared to the standard agent gadobutrol (EcGd, Gadovist).   "
95509|NCT02035995|"     Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes     and it is responsible for the morbidity of both mother and child. The aim of this study was     to determine retinal findings of gestational diabetes mellitus (GDM).   "
95524|NCT02035800|"     Broca II is the prolongation of the original study name BROCA. In BROCA study, only 25     patients participated and it was not enough to concluded clearly our hypothesis.   "
95525|NCT02035787|"     Purpose: This is an open label, single-arm, single-center study of the addition of metformin     to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable     non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1     endometrial adenocarcinoma (EC; n=15).      Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not     candidates for surgical management, and therefore are planned to start standard of care     treatment with the LR-IUD      Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until     disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial     endometrial biopsies will be performed, as per standard of care, to assess disease status.   "
95875|NCT02031211|"     Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic     Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient     symptoms if given in early CRPS.   "
95510|NCT02035982|"     There are few pharmacological treatments available for Alzheimer's disease, including drugs     called cholinesterase inhibitors: donepezil, galantamine, and rivastigmine. In research     trials, cholinesterase inhibitors have been shown to improve memory and problem behaviours in     people with mild to moderate Alzheimer's disease. However, these benefits may not extend to     the real-world when taking into account nursing home and health care costs. There is less     information on the use of cholinesterase inhibitors in people with severe Alzheimer's     disease. In Canada, only donepezil is recommended for the treatment of severe Alzheimer's     disease. However, there is no information on whether the benefits that donepezil provides to     people with severe Alzheimer's disease are sustained over the long term. Moreover, while the     tolerability of cholinesterase inhibitors is generally acceptable, their use is not     completely harmless. Common side effects include nausea, diarrhea, insomnia, vomiting, muscle     cramping, fatigue and loss of appetite.      In Ontario, cholinesterase inhibitor users tend to remain on these medications for two years     or more and often until death. The current cholinesterase inhibitor guidelines provide     details on what medication should be used, when it should be started and how it should be     monitored, but there is less clarity on when it is safe and appropriate to stop treatment.     The cessation of cholinesterase inhibitors in patients no longer appearing to display any     clear benefits may help to lower the risk of unpleasant side effects, lower the use of     multiple medications, and reduce the costs of caring for individuals with Alzheimer's     disease. However, the cessation of cholinesterase inhibitor therapy may run the risk of     deterioration in memory, worsening or development of behavioural symptoms and the placement     of additional demands on professional and unpaid caregivers.      There is a clear need for guidelines when to stop cholinesterase inhibitor treatment,     especially for patients in whom the benefits of not be on the medication will outweigh the     risks. The purpose of this study is to address this issue by collecting data which may be     helpful in predicting which types of patients may benefit from stopping cholinesterase     inhibitor treatment. Understanding when, and for whom, it is appropriate to stop     cholinesterase inhibitor treatment will influence the field of pharmacology in the treatment     of Alzheimer's disease.   "
95511|NCT02035969|"     This project aims to assess the effect of group peer support to children with HIV in relation     to adherence, virological treatment failure as well as physical development. A randomised     controlled trial (RCT) will be used where HIV+ children on antiretroviral treatment (ARV) and     their caretakers are randomized into either enhanced treatment support (ETS) through peer     supporters or the conventional treatment (CT) according to the guidelines of The National     AIDS Control Program. The treatment strategies will be assessed and compared in relation to     virological treatment failure as primary endpoint, immunological and clinical (AIDS events     and mortality) as secondary endpoints as well as treatment adherence and physical     development. The results from this project will lead to an increased knowledge in relation to     the impact of enhanced treatment support on adherence, virological suppression and resistance     development for children with HIV and have an impact on HIV treatment policies and guidelines     for Pediatric HIV in low-income settings globally.   "
95512|NCT02035956|"     Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of     intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or     without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma   "
95513|NCT02035943|"     In this study the investigators want to comare safety and efficacy of two different metods to     administrate insulin during parenteral nutrition.   "
95514|NCT02035930|"     The study was done to evaluate the effects of the follicular and luteal phases of the     menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50     during propofol anesthesia, in patients with and without preoperative intravenous     dexmedetomidine .   "
95515|NCT02035917|"     this study will perform to compare the results and functional outcomes of tibial plateau     fractures treated with non-locking and locking plate fixation.   "
95516|NCT02035904|"     The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion     with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate     breast reconstruction: this is a double blind, randomized, parallel group study. The study     moves from the concept that nociceptive stimulus last further than 48 hours after surgical     intervention: long term analgesia is necessary to provide a real benefit to the patient and     provide central sensitization. Intralesional catheter is placed at the end of surgery. In the     first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25%     5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS >4. From the second     postoperative day morphine PCA is removed and patients are randomized to receive     levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with     rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (Patrol).     Intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of     non-use.      Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed;     pain physicians also care about any catheter-related or drug-related side effect, registering     number of total boluses. Patients are provided with a home diary for pain scores to be filled     and brought back when surgical visit is performed. A phone interview at 1 and 3 month is     performed to investigate pain chronicization.      Surgical evaluation is provided, also to establish any catheter-related infective or healing     complication.      Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure     rehabilitation process.      A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to     understand differences in return to a normal quality of life and to social activities between     the two groups.   "
95535|NCT02035657|"     This is a single arm, open-label, single center study evaluating the safety, feasibility,     clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell     carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own     immune system in attacking the cancer cells.   "
95522|NCT02035826|"     Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite     strong evidence that reducing low-density lipoproteins (LDL) with statins successfully lowers     CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment when     indicated, and more than 50% of patients stop taking statins within one year of ﬁrst     prescription though such therapy typically should be life-long. In this study, we will test     the effectiveness of different financial incentives in increasing statin use and reducing LDL     cholesterol among patients with poor cholesterol control who are at very high risk for CVD.     The application of conceptual approaches from behavioral economics offers considerable     promise in advancing health and health care. We will test these approaches among patients at     very high risk of CVD at Harvard Vanguard Medical Associates. Using a 4-arm,     cluster-randomized controlled trial, we aim to answer these questions: [1] How does the     provision of patient incentives compare to no incentives at all? [2] Is success with patient     incentives improved by increasing the financial amounts? [3] Are results sustained after     incentives and other interventions are withdrawn?      Study Objectives and Hypothesis      Aim 1: To evaluate the effectiveness of varying patient incentives on improvement in LDL     cholesterol relative to usual care during a 3-month intervention among patients at high risk     of CVD. H1: Each of the incentives will be more effective than usual care in reducing LDL     cholesterol.      Aim 2: To evaluate the relative effectiveness of those intervention arms superior to control     in reducing LDL cholesterol. H2: Higher incentive amounts for patients will be more effective     than lower incentive amounts.      Aim 3: To evaluate the impact of each effective intervention in sustaining adherence and     reduced LDL after the 3-month intervention period.      Aim 4: To conduct a rigorous process evaluation to examine why some incentives were more     effective than others and to address other factors relevant to broader implementation.   "
95523|NCT02035813|"     Several studies have indicated that determining prevalence and number of circulating tumor     cells (CTCs) at various time points during treatment may be an effective tool for assessing     treatment efficacy in metastatic breast cancer (MBC). However, even if the prognostic value     of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in     predicting treatment response needs further investigation. DETECT IV is a prospective,     multicenter, open-label, phase II study in patients with HER2-negative metastatic breast     cancer and persisting HER2-negative circulating tumor cells (CTCs). Additional research on     CTC dynamics and characteristics will provide a better understanding of the prognostic and     predictive value of CTCs and is one step into a more personalized therapy for MBC.   "
95526|NCT02035774|"     Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate     their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of     the hand. The investigators think that this supination is caused by lateral rotation in the     shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is     innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal     positioning of the hand for surgery on the dorsal side of the hand may be achieved by     performing a SSN block (SSNB) in addition to the LSIB.   "
95527|NCT02035761|"     Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA     there is degeneration (progressive loss) of nerve cells in several brain and spinal cord     regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia,     incoordination, falls, slowness) to autonomic (fainting, bladder incontinence, sexual     dysfunction) to sleep problems (dream enactment, sleep apnea).      This research aims to help us better understand the patterns and timing of nerve degeneration     relatively early in the disease, and how this affects symptoms and progression. For instance:        1. Does MSA affect certain nerves that stimulate heart pumping? If so, does the severity of          loss of heart nerves affect disease progression and survival?        2. It is thought that MSA does not affect memory and thinking much, unlike other diseases          (such as Parkinson's). Is this accurate? Is there loss of nerves that transmit          acetylcholine (a neurochemical important in mental functioning)?        3. What can we learn about mood and sleep in MSA, through visualizing the serotonin system          in the brain? How does this relate to symptoms that subjects report in these often          underappreciated areas?      To answer these and other questions, investigators will take images of specific nerves in the     brain and heart using Positron Emission Tomography (PET) scans. Such imaging gives us     information that cannot be obtained from MRIs and CT scans. We will measure the levels of     several nerve cell types: serotonin, acetylcholine, and norepinephrine. Subjects will also     have many standardized assessments including quality-of-life and symptom assessments,     neurological examination, autonomic assessments, neuropsychological assessments, coordination     tests, and even assessments of vision and sense of smell. By pooling these results from many     MSA patients, and comparing with other diseases (such as Parkinson's disease) we hope to gain     a better understanding of what is happening early in MSA. Such knowledge could be very     valuable in future efforts to develop better therapies in this rare disease.   "
95528|NCT02035748|"     The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin     (JETREA®) over a 6-month follow-up period.   "
95529|NCT02035735|"     The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the     superficial extension of these tumors.   "
95530|NCT02035722|"     Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for     patients with wet age-related macular degeneration (AMD) An disadvantage of this technique is     the anxiety and discomfort which patients often experience due to the idea of getting a     needle in the eye. In addition, a recent case study indicated the importance of patient     education in achieving positive outcomes from intravitreal injections of anti-vascular     endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether     visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the     treatment, and lessen the impact of socioeconomical status on their understanding of the     treatment and prognosis.   "
95531|NCT02035709|"     Treatment of postoperative pain with hydromorphone (a strong analgesic) using     patient-controlled analgesia with target concentrations in blood compared to conventional     patient-controlled analgesia after planed cardiac surgery   "
95532|NCT02035696|"     To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to     < 48 months of age   "
95533|NCT02035683|"     The purpose of this study is to test whether an early metabolic response, measured by PET/CT     scan after the first cycle of chemotherapy, is able to predict which patients with advanced     NSCLC have a better prognosis.   "
95534|NCT02035670|"     The purpose of this study is to determine whether two-step method of diagnostic strategy is     effective in the diagnosis and treatment of fever of unknown origin (FUO). (TSMD research, a     pilot study) Fever of unknown origin (FUO) is a fever in excess of 38.3◦C continued for more     than 3 weeks, and its cause could not be identified by tests during hospitalization for more     than 1 week [1]. As diagnostic techniques such as imaging technology and clinical tests have     been developed and outpatient access to diagnostic tests have improved, the FUO is defined as     a shortened period where the cause could not be revealed despite diagnostic tests during     three visits to the outpatient department or during 3 days of hospitalization [2]. FUO can be     caused by many diseases, and causes can vary depending on region and time period. FUO was     first reported in the medical literature 80 years ago. Since then, the causative diseases     have greatly changed with changes in the social environment and widespread use of diagnostic     imaging. The causes of FUO, according to traditional diagnosis and treatment, could be     divided into four principal groups: infections, non-infectious inflammatory diseases (NIID,     including rheumatic diseases and vasculitic diseases), neoplasms, and other diseases. Despite     the development of various diagnostic techniques, 34-51% of FUO patients remain undiagnosed     [3,4]. In China, over-reliance on antibiotics for disease therapy and infection prevention     are common phenomena in traditional treatment of FUO[5].      Two-step method of diagnostic strategy is a method to diagnose FUO disease. First step is to     differentiate FUO according to the onset of disease and invasive pathogens. Second step is to     further differentiate FUO according to trends of disease and inflammation scores. The     diagnosis of FUO can be difficult for both patients and their physicians. Depending on the     experience and qualifications of the treating physicians, time to reach a diagnosis can vary.     Two-step method of diagnostic strategy would afford a standard method for physicians to     diagnoses the FUO.      So many reports of FUO have also been published in China, but have been limited to     single-facility or limited-region studies; no nationwide studies have yet been conducted.     Moreover, few assessments of tests used in the diagnostic evaluation of FUO have been     reported. In particular, few studies have assessed the clinical usefulness of tests such as     serum procalcitonin or positron emission tomography (PET) in China, although these tests are     now frequently used.      We therefore will conduct a multicenter collaborative retrospective and prospective     （randomized and controlled ）study of patients with FUO at hospitals affiliated with China's     Ministry of Health. This is the first nationwide study in China on diseases causing FUO and     the diagnostic workup, and identified diseases that should be considered when evaluating FUO     in China. In addition, we will investigate the rate of performing various tests in the     current diagnostic workup of FUO.      Classical FUO was diagnosed based on the definition by Durack et al[6] in patients meeting     all of criteria 1-4 below.      1. Fever with axillary temperature ≥38°C at least twice over a ≥3-week period. 2. Unknown     cause after three outpatient visits or during 3 days of hospitalization.      3. Not diagnosed with immunodeficiency before fever onset. 4. No confirmed HIV infection     before fever onset. The data described below were collected. No additional testing was     performed in this study due to insufficient data.        1. Patient characteristics: sex, age, concomitant disease, medical history and medication          history.        2. Clinical findings: subjective symptoms and objective physical findings.        3. Blood tests: blood count, biochemical examination and inflammatory markers (C reactive          protein (CRP), erythrocyte sedimentation rate (ESR), procalcitonin, etc.).        4. Results of blood cultures if performed.        5. Results of imaging studies and endoscopy if performed.        6. Results of cytology, histology, genetic testing or autopsy findings if performed.        7. Final diagnosis, day of diagnosis and outcome. This study is safety for no drug involved          to determine the effectiveness of two-step method of diagnostic strategy in the          diagnosis and treatment of fever of unknown origin.   "
95536|NCT02035644|"     The aim of the present study is to evaluate the efficacy and safety of Jinlida granules in     patients with inadequately controlled type-2 diabetes and dyslipidemia under life style     intervention.   "
95542|NCT02035566|"     People living in rural areas are at increased risk for poor health outcomes due to: long     distance to health care facilities, less available health care resources such as primary care     and specialty services, transportation problems, higher elderly population, poverty, high     uninsured rates and the lack of timely access to new technologies. Called Telehome Care     (THC), in the form of equipment in the home, may provide an innovative and potentially     cost-effective solution to enhancing chronic disease management services using technology and     may influence the reduction in emergency department (ED) visits and hospitalizations in rural     areas. However, telehealth research is still in its infancy, it is not well understood, and     is often done without an overarching scientific framework. The provision of in home health     monitoring and health education also may be a potential population based health research tool     for chronically ill patients. Demonstration of the possible benefits, patient acceptance and     satisfaction with THC requires a scientific approach as is used in this study.   "
95543|NCT02035553|"     This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in     patients with Alzheimer's disease psychosis.   "
95544|NCT02035540|"     This is a prospective, non-randomized, single-arm, multicentre surveillance study to be     conducted in Europe. The Surveillance is designed as a study, where        -  ESPOIR PV (pulmonary valve) is prescribed in the usual manner in accordance with the          terms of the approval.        -  The assignment of the patient to a particular therapeutic strategy is not decided in          advance by this Surveillance Protocol but falls within current practice and the          prescription of ESPOIR PV is clearly separated from the decision to include the patient          in the Surveillance.        -  No additional diagnostic or monitoring procedures shall be applied to the patients        -  and epidemiological methods shall be used for the analysis of collected data.      Evaluation of decellularized human heart valves for pulmonary heart valve replacement in     comparison to current valve substitutes. Safety endpoints include cardiovascular adverse     events, time to re-operation, re-intervention and explantation. Efficacy endpoints include     freedom from valve dysfunction and hemodynamic performance.   "
95553|NCT02035410|"     Cardiovascular implantable electronic device (CIED) infections have been increasing out of     proportion to the number of devices implanted We investigated recent trends and possible     causes of the increasing numbers of Cardiovascular implantable electronic device infections.   "
95703|NCT02033460|"     The purpose of this study is to know which combination of treatments are the most effective     in patients with non-specific neck pain. Study design: This is a single-blind randomized     controlled trial. (outcomes assessor). Study population: Men and women aged 18 to 60 years     old with neck pain for at least 12 weeks. Interventions: 3 groups will be treated for a     period of 4 weeks (8 sessions total; 2 per week).   "
95545|NCT02035527|"     This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and     docetaxel when given together with cisplatin and to see how well they work in treating     patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs     used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by     making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and     docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck.   "
95546|NCT02035514|"     Immunomodulatory therapies to treat the relapsing-remitting phase of multiple sclerosis (MS)     are designed to ameliorate the inflammatory processes that mediate the damage to the central     nervous system (CNS) and to delay progression of the disease. To date, there is no effective     means to stop the progression of disease and induce remyelination. Adult stem cells therapy     show great promise and is rapidly developing as alternative therapeutic strategy. We propose     the use of bone marrow-derived autologous Mesenchymal (BM-MSC) Stem Cells transplantation to     treat patients with relapsing-remitting MS (RRMS), despite immunomodulatory therapy. Taking     advantage of the potential that MSC possess strong immunomodulatory properties thought to     play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and     that may stimulate repair and regeneration of lesions, we plan a trial of a single injection     of autologous BM-MSC into eight patients. First, we aim to assess the feasibility, safety and     tolerability of autologous MSC therapy in RRMS. Second, we plan to evaluate the effects of     BM-MSC transplantation on MS disease activity by clinical, neurophysiological, immunological     and imaging assessments. Autologous MSC will be obtained from bone marrow aspirates, purified     by culture and characterized by surface antigen expression. A single dose of autologous     BM-MSC will be injected intravenously. Clinical, neurological and immunological assessments     will be scheduled at baseline (before BM-MSC transplantation) at 1, 3, and 6 months after     transplant. The imaging will be performed at 3 and 6 months after transplant. Proposed trial     will enable us to ascertain whether autologous BM-MSC transplantation is a feasible and safe     procedure, and whether BM-MSC can establish an environment of immune tolerance and through     the local production of neurotrophic/growth factors, might induce neuroprotection and     improvement in CNS function.   "
95547|NCT02035501|"     The purpose of the study is to investigate if treatment with L-Tyrosine improves selected     outcome measures of TNNT1 myopathy.   "
95548|NCT02035488|"     Bronchiectasis is a persistent and frequently progressive condition characterized by dilated     and thick-walled bronchi retaining sputum. The main symptoms of bronchiectasis are cough and     chronic sputum production. Until now, most patients with non-CF bronchiectasis receive     inhaled tobramycin every other month, by use of a nebulizer. However, this delivery system     has several disadvantages, like a low lung deposition and pollution with tobramycin in the     surrounding environment. With an efficient dry powder inhaler (DPI), a three to six fold     higher lung deposition compared to a nebulizer can be obtained. Therapy with a DPI is also     less time consuming compared to nebulisation. We will investigate dry powder tobramycin (DP     tobramycin) in a novel device in patients with non-CF bronchiectasis. The main objectives of     this study are to investigate the pharmacokinetic properties of DP tobramycin at different     dosages together with the local tolerability of DP tobramycin via the Cyclops® at different     dosages.   "
95549|NCT02035475|"     The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da     Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical     transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of     the instrument. Their use in this study will be to perform tissue transection during PLND     such that the intended use is within the FDA-approved domain for this instrument.     Investigators intend to identify whether its use for PLND reduces lymphoceles given that the     device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels     encountered during PLND. Because the instrument is new and has been FDA approved for less     than one year, there is no published literature regarding its use to date.      Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the     incidence of screening detected lymphoceles on that side. Investigators propose a total     sample size of 120 patients.   "
95565|NCT02035254|"     In this project, individuals at risk for cardiovascular disease who are looking to lose     weight or increase your level of activity, are offered access to an online lifestyle     management program.      Participants will use the website daily to improve their eating and exercise habits as well     as other aspects of healthy living. They will be asked to participate in online challenges to     motivate them to make lifestyle changes. Participants will meet with a health professional 3     times within the 6 month time period as well as receive monthly guidance and support by phone     or email for the website.   "
95550|NCT02035449|"     Difficult conditions and critically ill and injured patients may complicate endotracheal     intubation in the pre-hospital setting. The incidence of complications increase when two or     more endotracheal intubation attempts are needed.      The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal     intubation after the introduction of the McGrath MAC Video laryngoscope as the primary airway     device for pre-hospital endotracheal intubation.      Hypothesis:      • In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the     rate of difficult PHETI (defined as more than one intubation attempt needed to secure a     patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in     pre-hospital intubations.   "
95551|NCT02035436|"     Through many years, the standard care has been to use continuous sedation of critically ill     patients during mechanical ventilation. However, preliminary randomised clinical trials     indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA     trial is an investigator-initiated, randomised, clinical, parallel-group, multinational,     superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway     and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical     ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at     trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation     on delirium during admission and cognitive function after discharge from ICU.      Our hypothesis is that critically ill patients who are not sedated during mechanical     ventilation will have better cognitive function after discharge.   "
95552|NCT02035423|"     The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high     school students of both genders from different districts of Tehran, the Iranian capital, in     winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of     the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that     contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of     vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D     levels were checked in a subgroup before and after the intervention.   "
95554|NCT02035397|"     One possible angle for treating obesity could be slowing down the gastric emptying time. By     prolonging the gastric emptying time, the person would ideally experience increased sensation     of satiety, and in the long run reduce food intake. If such a treatment provides a clinically     significant weight loss, this could be an alternative for surgical procedures, avoiding the     risk for perioperative complications as well as complications in the long run.      There are now several pilot studies documenting that intragastric treatment with botulinum     toxin A (BTA) can be effective, although the treatment perspective is short and do not     include repeated injections. However, they demonstrate that BTA-injections are safe for the     patient. The treatment is administered by endoscopy.   "
95555|NCT02035384|"     This study is conducted in Europe, and North and South America. The aim of this study is to     provide additional documentation of the immunogenicity, and obtain additional clinical data,     of turoctocog alfa in the setting of normal clinical practise in patients previously treated     with a factor VIII agent (FVIII).   "
95556|NCT02035371|"     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic     (the exposure of the trial drug in the body) properties of FIAsp (faster-acting insulin     aspart) in children, adolescents and adults with type 1 diabetes.   "
95557|NCT02035358|"     In this Phase 1 Trial investigators plan to establish the MTD of HyperAcute®-Renal (HAR)     immunotherapy in subjects with clinically metastatic renal cell carcinoma.   "
95558|NCT02035345|"     This is a research study to determine if administering carboplatin at a slower rate when     re-treating recurrent ovarian cancer patients prior to the development of a hypersensitivity     reaction will decrease the frequency and severity of future hypersensitivity reactions.   "
95559|NCT02035332|"     The primary objective of this study is to evaluate the use of the Aurora Ablation System in     reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events     will be assessed along with an assessment of the reduction of uterine bleeding as measured by     a pictorial blood loss assessment chart (PBLAC) or menstrual diary.   "
95560|NCT02035319|"     In this research study investigators want to learn more about capillary malformations which     are also known as port wine stains.      Investigators are asking children with capillary malformations (port wine stains) to be in     the research, because investigators do not have a good idea of what to expect from the     current treatments of these malformations. These malformations are treated with laser as     clinically indicated and there are no standardized methods to assess improvement.   "
95561|NCT02035306|"     To answer the question whether a non-invasive haemaglobin measurement is clinically useful,     reliable and accurate as compared to taking a blood sample and checking the haemaglobin level     at the laboratory or in a blood gas analyser. This study will take place in a     multi-disciplinary ICU of critically ill patients.   "
95562|NCT02035293|"     A standardized diagnostic strategy of pulmonary embolism will be applied to eligible     patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer     assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of     the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed     for 3 months.   "
95563|NCT02035280|"     As the population continues to age, the prevalence of spinal deformity surgery for older     patients is increasing. Questions regarding the suitability of these patients to undergo     large spinal procedures and whether the outcomes merit the risks involved are not well known.   "
95564|NCT02035267|"     The objectives of this study are to explore the safety and efficacy of subcutaneous     injections of ATX-101 relative to placebo, in the submental area.   "
95590|NCT02034929|"     The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope     and helps to flatten large mucosal folds during withdrawal.      The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection     rate during colonoscopy.      The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp     detection.   "
95566|NCT02035241|"     The purpose of the study was to investigate how herbs and spices affect acute/postprandial     glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative     capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy     volunteers. We hypothesize that certain herbs and spices added to a standardized meal will     improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers,     compared with a similar meal without the corresponding plant materials.   "
95567|NCT02035228|"     The purpose of this study is to determine whether transcutaneous electrical stimulation     applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to     reduce hyperinflation in patients with chronic obstructive pulmonary disease.   "
95568|NCT02035215|"     The purpose of this study is to evaluate the efficacy and safety of combination therapy of     omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia   "
95569|NCT02035202|"     The purpose of this study is to evaluate the effectiveness of a mobile real-time cognitive     behavioral intervention for serious mental illness (SMI) and to identify the facilitators,     barriers, and costs of implementation. We would like to determine whether the addition of a     mobile phone monitoring software program to a brief behavioral intervention for bipolar     disorder or schizophrenia improves symptoms arising from the disorders. In this study we will     be assessing the feasibility, acceptability and short term effect of the mobile phone     enhanced intervention for bipolar disorder and schizophrenia.   "
95570|NCT02035189|"     An observational study in evaluating the clinical impact of procalcitonin on the care of Stem     cell transplant recipient and its performance as an adjunct in the diagnosis and     prognostication of Infectious processes   "
95581|NCT02035046|"     Gitelman syndrome is a salt wasting tubulopathy caused by mutations in the SLC12A3 gene     coding for the thiazide sensitive sodium chloride cotransporter. This disease mimics the     chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to     normal blood pressure, hypocalciuria and hypomagnesemia. The purpose of this study is to     determine whether the heterozygous carriers present the metabolic risks and/or the benefits     of this disease.   "
95571|NCT02035176|"     Autism Spectrum Disorders (ASD) feature impairments in social interaction and communication.     Drug and behavioral treatments for ASD are undergoing rapid development, yet our diagnostic     tools are not suitable for efficacy assessment. The Autism-Diagnosis Observational Schedule     (ADOS) is a clinical interview with the child and the gold standard for diagnosis. However,     this test is subjective, course grained and costly, precluding repeated tests of the same     child to assess treatment efficacy and large-scale control assessments of typically     developing (TD) children. For these reasons, the ADOS can impede imaging and genetic     research.      In light of these concerns, the Oregon Animation Test for Social Reciprocity (OATS) will be     developed to evaluate distinct autistic behavioral phenotypes, including joint attention,     empathy, imitation, and lack of narrative coherence. The main idea of OATS is that animated     characters and social scenarios are presented on a computer screen while the responses of the     child are recorded by video camera, microphone, and eye-tracking equipment. Animations are     used to test each behavioral phenotype of autism. The long-term vision for OATS is to     evaluate behavioral and physiological responses of autistic children, including heart rate     variability, pupil dilation, and EEG. Our first objective is to use existing animations to     build an OATS Prototype that discriminates autistic from normal children (Aim 1). From     these results, and use of a defined library of still frame posed images, we will design our     own animation platform to assess differences between autistic and normal children (Aim 2).   "
95572|NCT02035163|"     Atrial fibrillation after coronary artery bypass graft is a common complication.      The investigators have thought that the mechanism of temporarily postoperative atrial     fibrillation is closely related to the autonomic nervous system imbalance.      In a last several years, cryoablation was substituted for atrial incision in many reports to     simplify the maze procedure.      However, there has been no comparative study to delineate the feasibility of the use of     cryoablation.   "
95573|NCT02035150|"     Regular breakfast consumption may help lower body weight reduce body fatness and improve     cardiovascular disease risk factors. However, the best kind of breakfast to consume to     achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress     appetite, lower body weight and improve cardiovascular disease risk factors compared with a     no-fiber breakfast.   "
95574|NCT02035137|"     This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG)     and compare their effects on tumor response and associated side effects, to determine if one     therapy is better than the other for people diagnosed with relapsed or persistent     neuroblastoma.   "
95575|NCT02035124|"     Although there have been advances in the treatment of patients with metastatic     castrate-resistant prostate cancer (mCRPC), all patients eventually develop resistance to     available therapy. Docetaxel is the accepted first-line agent followed by cabazitaxel in the     post-docetaxel phase. In this study the investigators propose to evaluate BKM120, a PI3K     inhibitor, with cabazitaxel in the treatment of patients with advanced prostate cancer.   "
95576|NCT02035111|"     The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule     treating Migraine Headache.   "
95577|NCT02035098|"     The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in     improving the quality of pain management in hospitalised cancer patients. This is a     before-after cluster phase II study performed in medicine, oncology and respiratory disease     hospital wards. The Pac-IFicO programme is a complex interventions with multiple components.     The primary end-point of the study is the proportion of cancer patients with severe pain.   "
95578|NCT02035085|"     Six female patients (>18 years of age, pre-menopausal) who have had loco-regional (lumpectomy     and radiation) therapy for breast carcinoma and have been at least one-year disease free will     undergo liposuction, the autologous SVF cell fraction will be isolated and labeled with     CS-1000 in the operating room without entering cell culture, which will then be returned to     the patient at the site of breast grafting. Patients will receive a pre-screening MRI .     Patients will have an MRI scans over a period of 1 month at Johns Hopkins. Follow-up MRIs at     6,12, and 18 months will also be performed. Only at Johns Hopkins with fluorine being done as     part of this investigational study. By performing fluorine MRI and quantification of 19F     signal, we hypothesize that the engraftment of transplanted cells can be tracked in ways not     possible before, using the total fluorine signal as surrogate marker for cell persistence and     survival. We expect that a clinically successful outcome (maintenance of breast contour and     volume) will be positively correlated with cell survival. The outcome of this study may pave     the way for using 19F MRI cell tracking as a new tool for stem cell therapy in a variety of     clinical applications.   "
95579|NCT02035072|"     Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus     oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer.      Protocol code: IRST157.01      Phase: II      Study Design: monocentric, prospective, open-label not randomized trial.      Description of Study Treatment: radio-chemotherapy schedule        -  GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every          2 weeks for 4 cycles.        -  Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session          per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy          cycle.        -  Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy.      Objectives:      Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary     objective = the control of IM (internal margin) intra-fraction.      Step B: primary objective = to evaluate the proportion of the resectable patients after     radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of     combinated treatment;overall survival (OS); local progression free survival (LPFS) and     progression free survival (PFS).      Statistical Considerations:      Step A:      Assuming that the probability to observe a toxicity involving the radiotherapy treatment     discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for     toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be     observed in 11 patients, the treatment can be considered safe with a probability > 90%. If 1     toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more     patients needs to be recruited. If no further toxicity involving the radiotherapy treatment     discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%.      If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or     2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will     be observed, the study will be stopped because not safe and another kind of radiotherapy     schedule must be designed.      Step B:      If the radiotherapy treatment will be considered no toxic, the study will continue in Step B     : the goal of this phase II study is to increase the proportion of resectable patients of at     least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design     (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years,     and a further one-year period of follow-up is requested. If at least 7 patients out of 40     enrolled will be resectable, the hypothesis that the proportion of resectable patients will     be less or equal to P1 (P1=the proportion of resectable patients with the new     radio-chemotherapeutic treatment) will be refused and the treatment could be considered     active.   "
95580|NCT02035059|"     The objective of the study is, if an early oral glucose tolerance test combined with maternal     history, condition and multiple biomarker analysis can be used to detect gestational diabetes     mellitus in the first trimester (12-14 weeks of gestation).   "
95594|NCT02034877|"     This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65     years of age and in Indian children 6 to 17 years of age.   "
95582|NCT02035033|"     Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone     mass. The first step in the prevention and treatment of Op is ensuring adequate intake of     calcium and vitamin D . While calcium supplementations clearly slow bone loss in both     sexes,their effects on fracture risk are less certain. In contrast to the above a recent     randomized, placebo controlled trial in 1471 postmenopausal women (mean age 74) reported in     the BMJ (2 February 2008) found an increased rate of vascular events in healthy older women     receiving calcium supplementation. The mechanism is not clear .we are trying to identify a     possible correlation between calcium intake and calcium cardiac scoring .   "
95583|NCT02035020|"     The primary objective of this study is to investigate whether the treatment with IFN gamma     can induce significant accumulation of frataxin in FRDA patients, a possibility suggested by     pre-clinical evidence in an animal model of the disease.   "
95584|NCT02035007|"     The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac     Output)-derived transpulmonary thermodilution technology in patients with heart diseases.   "
95585|NCT02034994|"     The main objective is to evaluate the effects of a multicomponent, school-based intervention     combining change in nutritional behaviors with after school physical activity activities in     reducing the excessive weight gain in schoolchildren.   "
95586|NCT02034981|"     This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy     and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients     with identified activating molecular alterations in the crizotinib target genes. A cohort is     defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET     amplification).      For each cohort a two-stage design will be implemented. In the situation where expected     accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors     will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic     tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that     the target number may not be achievable in a reasonable timeframe; for these cohorts, the     alpha and beta errors will be fixed at 15%. Consequently three different statistical designs     will be a priori considered according to the expected response rate and incidence.   "
95587|NCT02034968|"     There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is     advantageous for advanced esophageal cancer patients in combination with chemotherapy or     radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with     greater efficacy,and with greater concentration in tumor tissue compared with normal     tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of     nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.   "
95588|NCT02034955|"     This study will ultimately aim to evaluate the side effects of treatment by asking 20     subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan     adapted after the first week of treatment to account for changes in the target shape. These     patients will be asked to complete toxicity scores and a quality of life questionnaire at the     start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of     radiotherapy. These results will be used to determine the feasibility of the proposed     approach, and obtain early estimates of improvements in uncertainty margin requirements for     this population of patients.   "
95589|NCT02034942|"     Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and     strength. This can attribute to prolonged admission, prolonged mechanical ventilation,     increased mortality and might have a negative impact on the physical function, degree of     independence and quality of life. The pathophysiological background for the loss of muscle     mass as well as possible effective treatment is still not well established. In the     NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily     wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never     been assessed whether non-sedation reduces the loss of muscle mass and strength.      Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on     physical function after discharge from ICU.      Hypothesis: that non-sedation during ventilator-treatment will improve the physical function     after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.   "
95613|NCT02034630|"     To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan,     fludarabine conditioning regimen in genetic rare disease   "
95591|NCT02034916|"     The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of     talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast     cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to     either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:        -  Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for          metastatic disease with disease progression > 8 weeks following the last dose of          platinum; or        -  Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic          disease and who have had no prior platinum therapy for metastatic disease   "
95592|NCT02034903|"     The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been     shown to vary greatly, and is influenced by individual provider practice. The clinical effect     of varying milk temperatures on preterm infant feeding tolerance has not been well studied.     The purpose of this study is to examine the effect of warming method, water bath versus     commercial warmer and its impact on feeding tolerance. Sample population will include     eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care     Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the     study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to     a control (water bath) or experimental (commercial warmer) group using a randomized sampling     scheme. After warming, and just prior to feeding, milk temperatures will be taken and     recorded by a trained data recorder. Feeding tolerance will be measured based on gastric     residual volume and length of time required to achieve full feeds. Based upon the available     evidence, the study investigators hypothesize that warming feeds to a consistent temperature     range using commercially available milk warmer will improve feeding tolerance and decrease     time to full feedings in preterm infants.   "
95593|NCT02034890|"     Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt     to reduce the incidence of urinary tract infections in patients after orthotopic neobladder     reconstruction.   "
95596|NCT02034851|"     Hypothesis: Administration of corticoids (dexamethasone) together with the conventional     antibiotherapy in the acute phase of a febrile urinary tract infection could reduce the risk     of renal scarring after 6 months of the primo-infection.      Primary objectives:To evaluate the reduction in incidence of renal scarring after 6 months of     a acute pyelonephritis between the control group (conventional therapy plus placebo) and     intervention group (conventional therapy plus dexamethasone.      Design: Multicentre randomized clinical trial,placebo controled, including children between 2     months and 14 years with a acute pyelonephritis proven by a acute phase DMSA     (dimethylsuccinic acid ). A total of 180 children in to parallel groups (intervention and     placebo) will be included.   "
95597|NCT02034838|"     This is an open-label, single group study to determine the pharmacokinetic profile of     atazanavir 300 mg daily boosted with ritonavir 100mg daily in HIV-infected patients over a     period of 9 days.      Ritonavir and atazanavir are protease inhibitors used to treat HIV. However, ritonavir, when     used at low doses (up to 100mg) does not have HIV activity, but will enhance (boost) the     blood concentrations of other drugs like atazanavir.      Recently, a study showed that taking 50mg of ritonavir administered in an oral solution led     to similar blood concentrations of atazanavir than when given with 100mg of ritonavir.     Potential benefits associated with a lower dose of ritonavir may include a reduction of side     effects such as upset stomach and an improvement in cholesterol level. This study will look     at the amount of atazanavir into your blood when given with ritonavir in a tablet formulation     at 50mg or 100mg with standard atazanavir dose (300mg).   "
95598|NCT02034825|"     This prospectively designed retrospective clinical utility study will evaluate urologists'     treatment recommendations before and after reviewing Decipher results for selected patient     cases.   "
95599|NCT02034812|"     This clinical utility study is based on a review of real but de-identified and randomized     patient cases and aims to evaluate radiation oncologist's treatment recommendations before     and after reviewing the results provided by the Decipher test. The primary intent is to help     guide development and design of future clinical utility studies for Decipher.   "
95600|NCT02034799|"     The objective of this study is to observe the clinical utility and performance of Bioseal     when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma     surgery.   "
95601|NCT02034786|"     Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by     loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of     normal tissue surface. Millions of plastic and reconstructive surgeries are performed     annually to repair soft tissue defects due to trauma, tumor resection and congenital defects.     Surgical options for lipoatrophy, the lipodystrophy type characterized by subcutaneous     adipose tissue atrophy, include: Transfer of autologous fat, Dermis - fat graft, Skin flaps     and Commercially available fillers.      Currently, the most commonly filler agent used for the lipodystrophy treatment is     polymethylmethacrylate, considered permanent and with a history of short- and medium-term     adverse effects. Biocompatible and temporary filler agents such as hyaluronic acid,     polylactic acid and collagen have been used for over 25 years for cosmetic purposes and in     lipoatrophies. More recently, the use of autologous fibroblasts proved to be efficient     solving acne scars and enabling dermis regeneration. Studies in mice showed that the     combination of pre - adipocytes with a biomaterial is much more effective in tissue     reconstitution than the injection of adipose tissue only, providing volume and also     stimulating cell proliferation and differentiation with increased production of extracellular     matrix.      This project aims a phase I clinical trial of a filler agent, composed of mesenchymal stem     cells derived from autologous adipose tissue associated with hyaluronic acid.   "
95602|NCT02034773|"     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses     of CC-220 in healthy subjects and to evaluate the relative bioavailability of a formulated     CC-220 capsule   "
95603|NCT02034760|"     Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65     years old) are recruited as subjects.      Upon inclusion, each individual will be randomized into one of the five groups stratified     according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy     Resistance Training (N=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50),     Protein Collagen (N=40-50) and Carbohydrate (N=30-35). The individuals randomized into one of     the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded     to the supplement content.      Assessments will be performed at Baseline (before intervention start), and after 6 and 12     months of intervention and again at 18 months (after 6 months of follow up).      The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12     months of intervention.      The primary hypothesis is that by applying the intension-to-treat analysis, the Light     Intensity Training group will increase quadriceps muscle cross sectional area just as much as     the Heavy Resistance Training group. The two training groups will gain more muscle mass than     the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate     groups that will loose quadriceps muscle cross sectional areas.   "
95604|NCT02034747|"     This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney     transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with     corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized     into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower     dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2     will receive the same corticosteroid dose for 24 weeks with Advagraf ®.   "
95605|NCT02034734|"     The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF)     pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects.     Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in     healthy young Caucasian male subjects and to assess the safety and tolerability of multiple     doses of ASP3652 in healthy young Caucasian male subjects.   "
95715|NCT02033304|"     In spite of identical analgesic protocols, parturients suffer different levels of pain     postoperative lay. In this study we hope to identify factors which influence the perception     of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.   "
95606|NCT02034721|"     Intense, eccentric resistance exercise causes muscle damage, soreness, inflammation, and a     loss of muscle function. Protein-amino acid supplementation before, during, and following     damaging resistance exercise may reduce muscle damage and accelerate recovery. This study     will determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo)     before, during, and after a 90-minute bout of eccentric exercise attenuates exercise-induced     muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speeds recovery of     muscle function, and maintains immune function in NASCAR pit crew athletes (Hendrick Motor     Sports).   "
95607|NCT02034708|"     The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as     compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of     overall lesion visualization and characterization (off-site assessment).      270 patients will be randomized between 2 arms defining the sequence of administration of the     contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14     days in between.      Each patient will, therefore, receive two MRI during his/her participation in the study.      The two arms consist in :        -  Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI.        -  Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI.      Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems.      MRI examinations will be evaluated centrally by blinded independent readers for the main     evaluation criterion.   "
95608|NCT02034695|"     Diabetes mellitus (DM) is one of the major cause of morbidity and among the top 10 causes of     deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has     initiated service improvement through introducing the risk assessment and management     programme (RAMP) to improve the quality of care (QOC) for DM patients in general outpatient     clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to     inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the     University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the     QOC of the programme.      The Action Learning and Audit Spiral methodologies to measure whether the target standard of     care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital     will be invited to complete a structured evaluation questionnaire. The data of all patients     who have enrolled into the RAMP for more than one year will be included in the evaluation on     the process and outcomes of care.      One thousand two hundred and forty-eight age and disease matched control patients who have     not been enrolled into the RAMP programme will be selected for the comparison in the outcomes     of care. A hundred and thirty participants will be followed up by telephone to evaluate the     effect of the programme in quality of life (QOL), patient enablement, and global rating of     change in health condition at baseline and 6 months after enrolment. Data on the process of     care will be retrieved from the HA medical records.      Main Outcome Measures: The primary outcomes are the proportion of participants who have     received the criterion process of care, and achieved the target HbA1c and blood pressure     levels.      Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC     criteria will be calculated. The changes in the clinical and patient reported outcomes of     RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample     t-test. The clinical outcomes between RAMP subjects and control group will be compared by     independent sample t-test or Chi-square test.      Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible     areas for quality enhancement will be identified.      Conclusion: The results of this study will provide empirical evidence on whether the HA's     RAMP programme can achieve improvement in QOC for DM patients. The information will be used     to guide service planning and policy decision making.   "
95609|NCT02034682|"     The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced     electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming     solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the     effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using     near-infrared spectroscopy (NIRS).   "
95610|NCT02034669|"     This study is designed to assess the safety and effect of autologous adipose derived stem     cell (ADSCs) transplantation in acute spinal cord injury patients.        1. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and          the complication after ADSCs transplantation.        2. To evaluate the effect of ADSCs isolation and expansion procedure.        3. To determine if functional outcome is improved following ADSCs transplantation in acute          spinal cord injury patient, using pre-transplantation spinal cord function as the          control.   "
95611|NCT02034656|"     The purposes of this study are to investigate the patterns of BCR-ABL mutations in CML and Ph     positive ALL patients with imatinib resistance during the year of 2001-2009 in Asian     institutes.   "
95612|NCT02034643|"     Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase     tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the     tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe     insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and     double-lumen tube.   "
95614|NCT02034617|"     When becoming a parent of a preterm infant there is an increased risk of stress. There are a     number of studies showing that parental stress has a negative impact on their engagement with     their child. Other studies, on the other hand, show that different intervention programs with     the aim to strengthen the relationship can decrease parental stress and hence affect the     parent-infant interaction in a positive way. Structured intervention programs for preterm     infants have also been successful in improving the infants' cognitive functions.      The investigators have developed a program with the aim to strengthen the parent-infant     interaction for late preterm infants. The observational program is called LiMoNid. Our     hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them     a deeper understanding of their child. They will hopefully develop more skills on how to     communicate with their child; to see, interpret, understand and approach the child, which can     lead to an improved parent-child interaction. Parental stress may also be reduced by     increased understanding and control. Regarding the child itself, we hypothesize that the     psychological development will be affected depending on the communication with the caregiver     and depending on the support it has received in expressing its feelings and needs. The     emotional regulation should be strengthened by such an intervention.      The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child     interaction.   "
95615|NCT02034604|"     This study is designed to evaluate efficacy and safety of naftopidil in patient with     neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.   "
95616|NCT02034591|"     The purpose of this study is to assess the bioavailability of Apixaban oral solution     administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban     administered as crushed tablet through a nasogastric tube relative to Apixaban solution     administered orally in healthy subjects.   "
95617|NCT02034578|"     The purpose of this study is to assess the bioavailability of Apixaban solution administered     through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban     solution administered orally in healthy subjects   "
95619|NCT02034552|"     The primary objective in this study is to evaluate bone scan response at Week 24 based on the     quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223 dichloride in     combination with abiraterone acetate or enzalutamide will be investigated. The study will     evaluate radiological progression free survival, overall survival, and skeletal events. This     study will also explore the clinical utility of different imaging modalities (whole body     quantified technetium-99 bone scan, DW-MRI and NaF PET-CT scan) and will have a separate     central radiological review for applicable secondary and exploratory imaging endpoints. All     subjects will be randomized as assigned randomly by the IXRS system in a 1:1:1 ratio into one     of the treatment arms: radium-223 dichloride alone, 50 kBq/kg (55 kBq/kg after implementation     of NIST update) every 4 weeks for up to 6 doses; radium-223 dichloride, 50 kBq/kg (55 kBq/kg     after implementation of NIST update) every 4 weeks up to 6 doses together with abiraterone     acetate 1,000 mg daily and prednisone 5 mg bid; radium-223 dichloride 50 kBq/kg (55 kBq/kg     after implementation of NIST update) every 4 weeks up to 6 doses together with enzalutamide     160 mg daily.The study will consist of screening, treatment and follow-up periods. Study will     continue until disease progression as determined by investigator, or when patient meets     criteria for withdrawal from study. Subjects in treatment arms with abiraterone/prednisone or     enzalutamide will have the option to continue taking oral study therapy until the end of the     study (2 years from the last dose of radium-223 dichloride) if the investigator deems the     subject may benefit and there is no clinical or radiological progression. Subjects who     discontinue all study treatment prior to 2 years from last radium-223 dichloride treatment     will enter active follow-up. During the active follow-up period, the subject will have a     safety visit at the clinic every 12 weeks from the EOT for up to 2 years from the last dose     of radium-223 dichloride. Beyond 2 years from last radium-223 dichloride treatment,subjects     will enter long-term follow-up and will be followed via phone contact at intervals to assess     for safety (hematological toxicity and new primary malignancies) and overall survival. A     separate long-term safety follow-up study protocol is planned. Once implemented, the study     subjects surviving after the end of the active follow-up will be transitioned to this     separate long-term safety follow-up protocol.   "
95620|NCT02034539|"     In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important     goal which can normally only be achieved after sufficient treatment of the underlying     ischemia (revascularization either by an operation, e. g. bypass, or a catheter     intervention). After successful revascularization everything should be done to improve wound     healing because this regularly takes weeks up to several months. One possibility to speed up     healing could be treatment with the VADOplex device which delivers an automatic intermittent     painless compression of the sole of the foot thereby increasing perfusion of the leg. This     system can be easily operated by patients themselves and at home.      Our goal is to prove that the VADOPlex system accelerates healing up and improves quality of     life.   "
95621|NCT02034526|"     Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and     associated with an increased risk of stroke and death. Within the first two years after     pacemaker implantation almost half of the patients are diagnosed with AF. Studies have     indicated that an increased amount of stimulation from the pacemaker in the atria is     associated with an increased amount of AF.      The aim of the present study is to test the hypothesis that a reduction of stimulation from     the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.   "
95622|NCT02034513|"     This trial is conducted in Europe and the United States of America (USA). The aim of the     trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine     (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1     diabetes.   "
95623|NCT02034500|"     This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of     a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different     dosages by different routes (intradermally, intranasally or intramuscularly) in healthy     adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB vaccine is     evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an aluminum     hydroxide suspension having the same concentration as study vaccine formulations. A total of     52 eligible subjects will be assigned to one of three sequential cohorts as follows:      Cohort A) 0.1 μg ID and 5 μg IN Cohort B) 1 μg ID and 20 μg IN Cohort C) 10 μg ID, 80 μg IN     and 5 μg IM Within each cohort, in an observer-blind fashion, subjects will be randomized to     receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen     concentrations) or GAHB placebo. Specifically for IN and ID administration routes, a Data     Safety Monitoring Board will be in place to receive a summary of all safety data obtained     during one week follow-up post-first vaccination with the lower dose. Based on evaluation of     the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether     the next cohort should be vaccinated with higher antigen concentration or not.      Expected duration of the study for an individual subject is 9 months. Each subject will be     followed-up for 6 months after the 3rd vaccination   "
95625|NCT02034474|"     Randomized, double-blind clinical trial of tocilizumab vs. placebo as add-on treatment for     residual positive, negative, and cognitive symptoms in schizophrenia. The primary study     hypothesis is that individuals receiving tocilizumab will show greater improvements in their     PANSS total scores than those taking placebo.   "
95626|NCT02034461|"     The investigators will study basic physiology of human peripheral nerves using high-count     microelectrode arrays implanted into peripheral nerves of patients with limb amputations or     peripheral nerve injury. These microelectrodes will be custom-made and are not available for     commercial distribution. The investigators hypothesize that recording neural signals from a     large number of microelectrodes will provide selective motor information in high enough     numbers to allow control over future artificial devices with many moving parts, i.e.     artificial limbs with shoulder, elbow, wrist, and/or individual fingers that move. These     studies will also investigate to what extent microstimulation of nerve fibers can provide     sensory feedback from a prosthetic limb.      The investigators will also conduct up to three acute surgeries where a Utah slanted     Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb     amputations. These acute implantations will provide Dr. Hutchinson with human surgical     experience in implanting USEAs and evaluating the containment system we will be using to     immobilize the implanted USEA in the nerve.   "
95627|NCT02034448|"     An observational registry to monitor the outcome of CRRT in adults with acute kidney injury.   "
95628|NCT02034435|"     Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone     system impairs glycemic control via effects on insulin sensitivity and insulin secretion.      Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone     system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor     dependent mechanism.   "
95641|NCT02034266|"     Nerves are made of different fats including omega-3s and omega-6s; however, dietary intakes     of omega-6s are very high and omega-3 intakes are very low. We hypothesize that omega-3     supplementation will stop diabetes related changes in cornea nerve structure in patients with     type 1 diabetes to stop the development of nerve injury associated with future risk of     neuropathy, and reflect changes in the degree of nerve injury over time. As such, we     anticipate that patients in the study will maintain Corneal Nerve Fiber Length (CNFL), the     primary outcome measure.   "
95629|NCT02034422|"     Hypertension affects 37% of the Veteran population, making it the most common medical     condition treated by the VA Health Care System. Physical activity is the first line of     defense in the treatment and management of hypertension. However, individuals with     hypertension have impaired muscle blood flow and exhibit exaggerated increases in blood     pressure during exercise (exercise pressor reflex or EPR) leading to exercise intolerance and     increased risk of stroke and heart attack. The cause of these impairments is not known, but     it is highly likely that free radical production and the subsequent increase in oxidative     stress plays a significant role. Two aims are proposed; Aim 1 will identify the physiological     consequences of elevated oxidative stress in hypertension, and Aim 2 will utilize an     antioxidant treatment to ameliorate the effects of an exaggerated EPR allowing the safe     performance of a clinical exercise rehabilitation program which will then, itself, attenuate     the EPR and reduce hypertension.   "
95630|NCT02034409|"     The purpose of this exploratory trial is to investigate whether PLIUS is potentially     effective as a disease and symptom modifying intervention in patients with early knee OA.   "
95631|NCT02034396|"     Currently, there is no standard approach for the treatment of patients with venous stasis     ulcers, and no means of accounting for the genetic factors that may contribute to a patient's     response to different therapeutic interventions. In order to determine whether, or to what     extent, genetic profiling of venous stasis ulcers can stratify patients according to their     potential for disease progression or healing, and guide preventive strategies and levels of     therapeutic interventions, the study will involve retrospective genetic profiling of patients     with a healed or persistent venous stasis ulcer as a means of determining the efficacy of     current therapies, and to establish a future prospective evaluation of treatment algorithms     based on genetic phenotype and variation. Results obtained from the 2 aforementioned groups     of participants will be compared with those of a control group of participants who have no     history of venous ulcer nor peripheral vascular disease.   "
95632|NCT02034383|"     The objective of this study is to measure the effect of processing (roasting, slicing, or     grinding) on the energy value of almonds in the human diet and study molecular mechanisms     that may help explain the beneficial health effects of almonds.   "
95633|NCT02034370|"     Obstructive Sleep Apnea (OSA) is when a person stops breathing repeatedly during sleep.     Breathing stops because the airway collapses and prevents air from getting into the     lungs.This airway closure results in a decrease in the amount of oxygen that is in the blood.     Anesthetics given during surgery are known to increase the tendency for a patient's airway to     close immediately after surgery in the recovery room and to reduce the amount of oxygen in a     patient's blood immediately after surgery. These two factors combined could have a profound     effect on a patient's well being after surgery.      Recent advances in general anesthesia, pain medications, and surgical techniques have made     outpatient surgery more common. Due to the increase in outpatient surgeries, pain management     techniques that will work efficiently and for longer periods of time are necessary. One of     these techniques is a nerve block, which coats the nerve with a numbing medication and blocks     all pain from that area. Nerve blocks are routinely used along with general anesthesia for     outpatient surgeries and help reduce or eliminate the need for IV or oral pain medicine after     the surgery. Nerve blocks can provide good pain relief with early recovery and fewer side     effects (nausea, vomiting, etc.) related to narcotic pain medicines.      Unfortunately, there are no studies that look at the effect of anesthesia and nerve blocks on     breathing patterns and oxygen saturation levels after discharge from outpatient surgery. We     therefore propose to study the changes in lung function tests and blood oxygen levels after a     nerve block and general anesthesia for outpatient shoulder surgery. We would like to conduct     a home sleep study including measuring oxygen levels while subjects are sleeping, before,     during and after surgery, and test lung function both before and after surgery to see if     there are any differences.      We will recruit 10 subjects with eligibility based on clinically indicated shoulder surgery     and a nerve block. The study will be non-interventional during surgery.      It is possible that future screening for out-patient shoulder surgery includes preoperative     overnight oxygen saturation measurement to identify patients at high-risk of changes in     oxygen levels. These patients may benefit from hospital admission after surgery for close     observation. Thus, this study could have significant implications for patient safety and     resource utilization.   "
95634|NCT02034357|"     The purpose of this study is to determine the impact of sleep and breathing problems during     sleep on memory, attention, and general well being (quality of life) in people with Parkinson     Disease.   "
95635|NCT02034344|"     The purpose of this study is to obtain skin, blood, and urine samples from patients with     active cutaneous lupus lesions and from healthy participants.   "
95650|NCT02034149|"     This study is being implemented for 3 aims. The first has been to conduct a systematic     literatures review on CKD intervention models and their effectiveness. Findings have been     adopted in our intervention program. The second purpose is to establish a practical     management model or an intervention model for CKD patients and high risk population with the     18-month of follow-up.In the third year, we will use social perspective point to evaluate the     costs and the benefits of intervention.   "
95651|NCT02034136|"     Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters     such as cholesterol, blood pressure and glucose.      Randomized Control Trial.   "
95636|NCT02034331|"     Persons with spinal cord injury (SCI) are at an increased risk for metabolic disorders,     including that of insulin resistance. As a result of neurological injury, they often have     impaired mechanisms that regulate blood vessel function below the level of injury. Insulin,     which facilitates the transport of glucose into muscle cells, is also capable of regulating     skin blood flow, with insulin resistance reducing perfusion. Although beyond the scope of     this proposal, the possibility exists that impaired microvascular skin blood flow responses     due to insulin may further predispose to ischemia of the skin at pressure points of bony     prominence. This perturbed cutaneous vascular response may place persons with SCI at risk for     the development and poor healing of pressure ulcers due to microvascular dysfunction     secondary to neurologic and metabolic disorders.      Primary Aim: To determine the association between systemic insulin sensitivity and     insulin-mediated vasodilatation below the neurological level of injury.      We hypothesize that individuals with systemic insulin sensitivity compared to those with     insulin resistance will have greater insulin-mediated vasodilatation and an associated     proportional increase in cutaneous blood perfusion. Thus, intact and appropriate     endothelial-mediated regulation by insulin will be operative despite sub-lesional     neurological impairment in insulin sensitive individuals with SCI. However, because of the     absence of the SNS-mediated insulin action on the microvasculature (i.e., insulin-mediated     sympathetic withdrawal), it is being hypothesized that the vasodilatory response to     iontophoresis with insulin in insulin sensitive subjects with SCI will be less than that     observed in neurologically intact controls with insulin sensitivity.      Secondary Aim: To compare peak microvascular perfusion responses to endothelial-dependent     vasodilatation by iontophoresis with acetylcholine to insulin.      We hypothesize that the peak blood perfusion responses to iontophoresis with insulin will be     comparable in magnitude to that of acetylcholine in individuals with greater systemic insulin     sensitivity. This will be in contrast to individuals with systemic insulin resistance who     will demonstrate a diminished response to iontophoresis with insulin when compared to that of     acetylcholine. Because of SNS impairment, the peak vasodilatory response observed to these     interventions will be lower in the group with SCI.   "
95637|NCT02034318|"     The purpose of this research study is to learn about a possible association between cardiac     denervation (the breaking down of nerves in the heart) and the development of fatigue in     Parkinson's disease (PD).   "
95638|NCT02034305|"     This study is to determine whether physiologic measures (peak cough flow, measures of     respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict spontaneous     cough clearance (as measured by a nuclear medicine study) in children with neuromuscular     disease. It will also determine whether airway clearance is augmented by high frequency chest     wall oscillation.   "
95639|NCT02034292|"     Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and     clopidogrel.   "
95642|NCT02034253|"     The early stages of schizophrenia are associated with significant decreases in social and     intellectual abilities, with more declines in chronic disease. Studies have identified     relationships between duration of untreated psychosis (the duration between the onset of     positive symptoms and treatment) and worse long term outcomes. However, the neurobiology of     this phenomenon and its implications for response to antipsychotic medications remain poorly     understood.      Glutamatergic excess altering brain connectivity might provide an explanation for why those     with longer duration of untreated psychosis have worse clinical outcomes. The investigators     propose to use neuroimaging to study 67 first episode psychosis subjects before and after     sixteen weeks of treatment with risperidone, a common antipsychotic. We will measure (1)     glutamate and (2) structural and functional brain connectivity and test the hypotheses that     glutamatergic abnormalities are present in first episode patients and that longer duration of     untreated psychosis is associated with greater connectivity abnormalities that set the stage     for poor response to treatment. 67 demographic-matched controls will also be recruited as a     comparison group - healthy controls will not receive antipsychotic medication.      The investigator's previous studies have made progress in the understanding of abnormalities     in the glutamate system and brain connectivity in unmedicated patients with schizophrenia and     modulation of these by antipsychotic medication. Two indices of glutamatergic dysfunction     have been identified. While antipsychotic medications appear to modulate glutamate, the     disturbance in the relationship between metabolites is not restored with treatment. In     addition, the investigators found that both structural and functional connectivity     abnormalities in unmedicated patients with schizophrenia predict patients' response to     treatment.      To the investigator's knowledge, no other group has performed a study that uses a combination     of complementary neuroimaging techniques that will allow generating a broad characterization     of glutamatergic function and brain connectivity in first episode psychosis and change with     treatment. The results of the proposed studies could suggest a mechanism by which the     duration of untreated psychosis is associated with poor treatment response which might lead     to new interventions to target the illness.   "
95643|NCT02034240|"     Patients with severe infection and sepsis are in high risk of hypo perfusion and therefore     organ affection. Temporary or permanent kidney failure is a common complication in these     patients. Today's golden standard for kidney failure detection is creatinine levels rising     and / or oliguria. The investigators hypothesize that an even more sensitive biomarker;     neutrophil gelatinase associated lipocalin(NGAL) in urine can predict kidney injury before     creatinine levels rise. In recent studies NGAL in urine seem to be a sensitive biomarker in     these patient to predict kidney injury, but the time factor for sampling optimally is not     known. In this pilot study the investigators sample the urine at admission within the first     hour of hospitalization to investigate if NGAL can be used as a predictor in an emergency     setting.   "
95644|NCT02034227|"     The purpose of this study is to determine if the experimental drug, SG2000 is safe and     tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and     acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who     are not candidates for other types of standard therapy.   "
95645|NCT02034214|"     The SHAZ! study was a randomized trial that compared a package of life skills education,     reproductive health care services, and economic livelihood development to a control package     of life skills education and reproductive health care services alone. SHAZ! enrolled young     women 16 to 19 years old who had been orphaned and who were currently out of school and not     infected with HIV. Individuals participated in the project for up to two years.   "
95646|NCT02034201|"     Methamphetamine dependence is a serious public health problem, with methamphetamine abusers     being at risk for significant morbidity and mortality, including HIV. To date, no medication     or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder.     This clinical trial will examine whether lisdexamfetamine shows promise in alleviating     withdrawal symptoms and preventing relapse relative to placebo in recently-abstinent     methamphetamine dependent individuals. Findings of this study will not only shed light on     whether lisdexamfetamine may improve upon treatment for this disorder but also inform future     medication development strategies for improving treatment for drug dependence disorders.     Discovering efficacious limited risk interventions that show more robust, longer-term     outcomes would be beneficial both to the individual and society.   "
95647|NCT02034188|"     Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once     per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS)     patients.   "
95652|NCT02034123|"     GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase     1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity. This is     a phase I, open-label, multi-center, non-randomized, 2-part first time in human (FTIH) study     for GSK2879552. Part 1 is a dose escalation phase to determine the recommended phase 2 dose     (RP2D) for GSK2879552 based on the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) profiles observed after oral administration of GSK2879552. Any dose     level(s) may be expanded up to 12 subjects in order to collect additional data on PK and     PD.The safety and PK/PD data will be reviewed prior to the dose decision, and the dose     escalation will be guided by the Neuenschwander -continuous reassessment method (N-CRM).     Built-in safety constraints are in place to prevent exposing subjects to undue risk of     toxicity. Once RP2D is identified, an expansion cohort (Part 2) of up to 30 subjects will be     enrolled to further evaluate the clinical activity and tolerability of GSK2879552 in subjects     with relapsed/refractory SCLC.   "
95654|NCT02034097|"     Foretinib (GSK1363089) is an investigational, oral, multikinase inhibitor involved in     invasion, migration, and angiogenesis. This is a phase II, open label, uncontrolled,     parallel, multi-cohort, multicenter 2-stage study to assess the safety and efficacy of     foretinib and erlotinib combination therapy and foretinib monotherapy in genomic     subpopulations of Non-Small-Cell Lung Cancer (NSCLC) subjects.   "
95689|NCT02033642|"     The first purpose of this randomized controlled trial is to test the efficacy of a     24-session, 6-month family-based behavioral intervention (FBBI) - as compared to a delayed     treatment group which later receives the same FBBI - that targets weight loss in     adolescents/young adults with intellectual disability aged 15-22 years. The second purpose of     this randomized controlled trial is to examine the efficacy of a 12-session, 6-month     Maintenance intervention that targets maintenance of weight loss in the same population of     adolescents/young adults with intellectual disability. The Maintenance condition follows the     completion of each FBBI group and involves a re-randomization to either the Maintenance     intervention or no further intervention. Outcome measures include Body Mass Index (BMI),     waist circumference, physical activity/sedentary behavior (measured via accelerometry),     dietary patterns (3-Day Food Records), self-efficacy and psychosocial characteristics     (Adolescent Depression and Anxiety Scale). Hypotheses are that (1) participants in the FBBI     condition will lose more weight (reduced BMI) than participants in the delayed treatment     condition, and that (2) participants in the Maintenance condition will maintain weight lost     (reductions in BMI) or experience less weight regain, as compared with participants who     receive no further intervention following FBBI.   "
95655|NCT02034084|"     Previous studies have shown that the transradial cardiac catheterization has decreased not     only bleeding complications related to the access site and procedural discomfort but also     morbidity and hospitalization as compared to transfemoral approach. At present, the right     radial approach (RRA) is the first choice routinely for coronary angiography and     interventions in daily clinical practice despite more marked subclavian artery tortuosity     than left radial approach (LRA). Although LRA has been thought to be more direct access to     the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and     cerebrovascular complications compared with RRA, the application of LRA for coronary     intervention is still low. Moreover, several studies have also obtained conflicting results     showing no difference in procedural success rate compared LRA and RRA using Judkins     catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and     feasibility for coronary angiography and interventions in real world practice and few data of     randomized control trial are available.      The aim of this study was to randomly investigate and compare the safety and feasibility of     LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.      The investigators will enroll consecutively for 2 years all patients undergoing coronary     diagnostic procedures through trans radial approach.      The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy     time, dose of radiation including cumulative air kerma and dose area product, contrast volume     and the incidence of vascular complications.   "
95656|NCT02034071|"     • This is a single-center, open-label, single-arm study with a double-blind,     placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of     about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about 2.4     mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5.1 mg/kg (maximum dose of 507.5 mg). These DCCR doses are     equivalent to diazoxide doses of 1.03, 1.66, 2.28, 2.9, and 3.52 mg/kg. The administered dose     will be as close to the mg/kg dosing as can be achieved by the available dose strengths of     DCCR. Patients will be up-titrated at each visit at the discretion of the investigator. All     patients will be continued in the double-blind, placebo-controlled, randomized withdrawal     extension. Any patient who showed an increase in resting energy expenditure and/or a     reduction in hyperphagia from Baseline through Day 55 or Day 69 will be designated a     responder, whereas all others will be designated non-responders. Responders will be     randomized in a 1:1 ratio either to continue on active treatment at the dose they were     treated with on Day 69 or to the placebo equivalent of that dose for an additional 4 weeks.     Non-responders will continue open label treatment during the extension.   "
95657|NCT02034058|"     The primary objective of this study is to evaluate the rate of stroke and/or death in     patients treated with the Wingspan Stent System, according to the Indications for Use, within     72 hours post procedure.   "
95658|NCT02034045|"     Initiatives aimed at reducing Emergency Department (ED) wait times and improved community     health initiatives are major priorities in Canada. Three of the most common chronic diseases     worldwide are Diabetes Mellitus (DM), Congestive Heart Failure (CHF) and Chronic Obstructive     Pulmonary Disease (COPD). These diseases are on the rise and currently cost the Canadian     health care system billions of dollars every year including the cost of hospitalizations and     ED visits. The existing health care system does not have the resources and manpower to     effectively care for these patients in the future.      Paramedics are currently employed to provide Emergency Medical Services in remote, rural and     urban settings in Canada.      They are highly trained health care practitioners that are mobile in the community and     currently work in a physician medically delegated act model and therefore are positioned to     take on new collaborative roles to deliver patient care in the community setting. Increased     community paramedic care could decrease the utilization of the health care system resources     for patients with chronic disease. Using a randomized control trial design we will attempt to     answer the question of whether whether non-emergency community paramedics conducting home     visits to undertake assessments and evidence-based treatments of patients in partnership with     family doctors will decrease the rate of patient hospitalization.   "
95664|NCT02033967|"     Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This     procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke     volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload.     The investigators try to evaluate the relationship between CVP and SVV during CVP-guided     vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced     hypovolemia using the SVV calculated from the validation study will be tested (feasibility     study).   "
95665|NCT02033954|"     To collect confirmatory data in support of the safety and performance of the ArtVentive     Medical Group Endoluminal Occlusion System.   "
95666|NCT02033941|"     Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia. Our     proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD     subjects. As secondary measures, we will also provide the essential human data to guide the     design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration     in AD patients.   "
95667|NCT02033928|"     The purpose of this research study is to describe a patients' fitness before and after     treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of     measuring a patient's current quality of health. With surveys, questionnaires and blood     tests, we hope to create a tool that will give a good picture of patients' ability to     tolerate treatment. In the future, we hope to devise the best treatment for a patient based     on their fitness.   "
95690|NCT02033629|"     The development of target effect-site controlled concentrations (TCI) of remifentanil have     gained increasing acceptance during cardiac surgery as regarding the resulting of hemodynamic     stability and early extubation. The use of low-dose opioid technique has been progressively     used nowadays because of its ceiling effect to attenuate cardiovascular responses to noxious     stimuli. We hypothesize that the use of low target remifentanil effect site concentrations     may provide comparable shorter times to tracheal extubation and hemodynamic stability to the     use of high remifentanil Ce during target-controlled propofol anesthesia for cardiac surgery.   "
95790|NCT02032316|"     A prospective, single-center, single-arm, trial to demonstrate safety and device performance     of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man     clinical study in a small human population.   "
95668|NCT02033915|"     Suicide attempters or people with self-harm have a high percentage in seeking medical     services before and after their suicidal or self-harm behaviour compared to general     population. Studies revealed that apart from psychiatric services, they were more likely to     seek help from doctors of various units (e.g. emergency departments, general medicine,     medical-surgical units) across different healthcare systems (i.e. hospitals or district     clinics). Besides, suicide event was possibly heard on in-patients of psychiatric or     non-psychiatric units. People with self-harm experienced poor communication with healthcare     personnel, and they perceived staff's lacking knowledge about suicide as serious problems. In     Taiwan it was also found that emergency nurses and general practitioners were in need of     improving negative attitudes and enhancing knowledge towards suicidal behaviour. From the     point that nurses are the healthcare personnel that spend the most time with in-patients     compared to others in the hospital, suicide risk assessment training may enhance nurses'     attitudes and ability of risk awareness and assessment towards people with self-harm, which     may in turn significantly increase the identification rate of the high risk group for     suicide. Currently there is a lack of suicide training program as a reference for nursing     education in Taiwan. The study therefore aims to strengthen suicide risk assessment ability     among clinical nurses through interactive discussion groups. Using quasi-experimental design     with randomized cluster sampling strategy, a case vignettes will be used for suicide risk     assessment together with other measurements regarding suicide knowledge and attitudes for     both experiment and control groups before and after the training course.   "
95669|NCT02033902|"     The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel)     as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.   "
95670|NCT02033889|"     This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes     mellitus and inadequate glycemic control on metformin monotherapy. The primary study     hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for     ertugliflozin is greater than that for placebo.   "
95671|NCT02033876|"     This study will evaluate whether bile acids are able to increase insulin sensitivity and     enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance     glycemic control. These observations will provide the preliminary data for proposing future     therapeutic as well as further mechanistic studies of the role of bile acids in the control     of glycemia in T2DM.   "
95672|NCT02033863|"     To collect confirmatory data in support of the safety and performance of the ArtVentive     Medical Group Endoluminal Occlusion System.   "
95673|NCT02033850|"     Background: Subcortical Vascular Dementia (VaD), consequent to deep brain small vessel     disease (SVD), is the most frequent form of VaD. The term vascular mild cognitive impairment     (VMCI) defines a transitional state between normal ageing and VaD. Attentional deficits are a     common finding in patients affected by VMCI or subcortical VaD. At present, no drug treatment     is available to prevent vascular dementia in patients with VMCI or to improve cognitive     performances of this large group of patients. Cognitive rehabilitation is directed to achieve     functional changes by reinforcing, strengthening, or reestablishing previously learned     patterns of behavior, or establishing new patterns of cognitive activity or compensatory     mechanisms.      A hierarchical model of attention has been used to build the Attention Process Training-II     (APT-II) programme.      The APT-II programme effectiveness have been demonstrated in traumatic brain injury and     post-stroke rehabilitation, but there is an increasing interest in the study of cognitive     rehabilitation in pathological processes that evolve over time, such as chronic     cerebrovascular diseases (CVD).      Aims: The purpose of this study is to investigate whether the APT-II programme could be a     useful tool in the rehabilitation of attention in individuals affected by VMCI with SVD, and     if so, whether the improvement in performance is generalized to functionality in daily     activities and quality of life.      Main Expected Results and Impact: Considering that the APT-II contains specific exercises to     facilitate generalization to daily life, the skills that are learned by each patient during     the rehabilitation programme should be generalized to daily activities.      Furthermore, the improvement of cognitive skills should also improve patient's overall     quality of life because these learned skills are applicable to real-life situations. The main     expected results are: 1) an impact of APT-II on disability, everyday cognition, quality of     life, and performance on attention tests at short and long term after rehabilitation     programme ending as compared with standard care; 2) a reduction of the risk of transition to     dementia at 1 year follow-up as compared with control group.   "
95674|NCT02033837|"     The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical     indications and appropriateness of cardiac CT has not been adequately investigated. The     purpose of the survey is to assess the distribution of appropriateness ratings and test     outcomes of cardiac CT with second-generation ADCT.   "
95675|NCT02033824|"     The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue     formation in craniectomy patients as well as facilitating reoperation and repair.     Specifically this study compares craniectomy without dHACM application to craniectomy with     placement of dHACM between the galea and dura over dural suture line and/or exposed     parenchyma.   "
95676|NCT02033811|"     Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic     alternative to surgical valve repair (PMVR) in high risk patients.      The aim of this registry is to collect prospectively and systematically clinical research     data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end     observational study to assess the characteristics and outcomes patients with severe mitral     regurgitation undergoing PMVR.   "
95678|NCT02033785|"     Holmium laser prostatectomy will enhance voiding function.      Holmium laser prostatectomy will enhance sleep quality.      Holmium laser prostatectomy will enhance renal function.      Holmium laser prostatectomy will enhance erectile function.      Holmium laser prostatectomy will enhance the health-related quality of life.   "
95679|NCT02033772|"     The study is primarily a descriptive study examining the physiological, ventilatory,     surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic     surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2     (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.   "
95701|NCT02033486|"     Screening for breast cancer improves early detection of aggressive cancers and has been shown     to reduce breast cancer related mortality. Currently, mammography is the most effective way     of detecting early stage, non palpable breast cancers. However, mammography only reveals the     breast structure, and cannot say much about the breast physiological state. We propose     Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly technique that     is non-invasive and does not use non-ionizing radiation. TOBI uses near infrared light and by     measuring how such light passes through the breast, images of blood volume and hemoglobin     oxygenation can be obtained. In this study, TOBI is combined with digital breast     tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the TOBI-DBT     combined images can be used to diagnose breast cancer with significantly improved sensitivity     and specificity compared to DBT alone.   "
95680|NCT02033759|"     We propose to study the impact of BIA screening on anxiety and primary prevention strategies     for lymphedema development among patients with recent surgery for breast cancer. Currently,     professional societies recommend scheduled follow-up visits to screen for lymphedema after     recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified     lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk     reduction strategies, measurement of the affected limb with a tape measure, and physical     inspection for physical changes consistent with lymphedema. In the proposed study, patients     will be randomly assigned to the addition of BIA screening vs. usual care. At each screening     visit, all patients will be assessed for their current lymphedema risk behaviors, as outlined     by the National Lymphedema Network (7). To evaluate anxiety levels, all patients will be     asked to fill out the Beck Anxiety Inventory, a validated screening tool used in prior     studies of patients with breast cancer (8,9). This questionnaire will be administered at each     follow-up lymphedema screening visit, and the baseline will be administered at the     preoperative visit. For patients randomly assigned to BIA screening, this involves the     placement of adhesive electrodes on the each wrist and an ankle, followed by connection of     the electrodes to the BIA machine, which then uses a painless electrical impulse to measure     impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2     upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk behaviors     and anxiety levels between those patients with vs. without BIA screening.   "
95681|NCT02033746|"     Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on     buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6     weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality     of life and decrease drug cravings ultimately while facing everyday life stressors.   "
95682|NCT02033733|"     After successful resuscitation from cardiac arrest, cooling the whole body is a well     established treatment that improves the chances of the brain recovering. This however, has to     be done within a certain time-frame from the arrest. The purpose of this study is to explore     the best way of dosing the muscle relaxing medications that are given during the cooling     process.      Hypothesis: In the context of our institutional therapeutic hypothermia protocol,     cisatracurium infusions lead to faster drops in core temperature when compared to     cisatracurium prn boluses alone.   "
95683|NCT02033720|"     After successful resuscitation from certain types of cardiac arrest, total body cooling is     now a well established treatment that improves the chances of the brain recovering. This     however, has only been definitively proven after a certain type of cardiac arrest that is     ventricular fibrillation / ventricular tachycardia. The purpose of this study is to explore     if total body cooling is beneficial for patients recovering from another type of cardiac     arrest that is pulseless electrical activity.      HYPOTHESIS:      Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological     outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison     to asystole.   "
95684|NCT02033707|"     This non-treatment study will investigate the effects on mood and performance caused by     hallucinogens and other psychoactive compounds.   "
95685|NCT02033694|"     The purpose of this study is to enhance medical knowledge of the causes of future coronary     problems. Many studies in patients who have already experienced a coronary problem point to     the danger associated with plaques that are rich in cholesterol. This study determines if the     near-infrared method of detection of these fatty plaques can predict future events. If     dangerous plaques can be identified, there are many treatments already available that could     be tested for their ability to prevent coronary events.   "
95686|NCT02033681|"     The aim of this study is to know the characteristic of one-per-mil tumescent solution in     regards of the optimal time delay to achieve optimal visualization of operation field in hand     and digit surgery.      Hypothesis:        1. Epinephine in one-per-mil concentration by tumescent injection technique will provide          faster decrease in oxygen saturation compared to normal saline solution injected by          tumescent technique.        2. Epinephrine in one-per-mil concentration by tumescent injection technique will provide          effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay.        3. Epinephine in one-per-mil concentration by tumescent injection technique causes no          finger necrosis as normal saline solution injected by tumescent technique.   "
95687|NCT02033668|"     This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous     (SQ) administration for subsequent studies with GSK933776 by characterizing the safety,     tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM     and SQ administration in healthy volunteers. Such alternate routes of administration may     provide more options in the selection of an efficacious dose for subsequent development in     patients with geographic atrophy. There will be four treatment arms in the study and     participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The     planned number of evaluable participants for this study is 24 with 6 participants completing     all critical assessments in each of the four treatment arms. The total duration of     participation from screening to follow-up for Treatment Arms A, B and D (single dose of     GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat     dose of GSK933776) will be approximately 134 days.   "
95688|NCT02033655|"     The purpose of the trial is to assess the effects of combining regular, generous intakes of     high quality protein (primarily from lean pork and other animal source proteins) with calorie     restriction on functional status and lean muscle mass in frail, obese, women who participate     in a 6 month intervention and 9 month intervention.   "
95702|NCT02033473|"     The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The     apelin and its receptor, which is named apj, are expressed in many tissues including     sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.      Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of     investigation, demonstrating for the first time in mouse models that apelin exerts a     glucose-regulating in vivo action. The investigators propose a translational clinical     research project whose goal is to provide the proof of concept of the favorable influence of     apelin on insulin sensitivity in humans.   "
95691|NCT02033616|"     This is a double-blind study in which approximately 99 study patients will be randomized in a     2:1 ratio to receive either ovapuldencel-T (autologous dendritic cells loaded with irradiated     autologous tumor cells in GM-CSF) or MC (autologous PBMC in GM-CSF). Patients eligible for     treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line     has been established, (3) who have undergone leukapheresis, (4) are scheduled for primary     adjuvant chemotherapy, and (5) have an ECOG performance grade of 0 or 1.      The primary endpoint of this trial is death from any cause with the metric of overall     survival (OS) from the date of randomization. Progression-free survival (PFS) will be a     secondary endpoint and will be calculated as the time from the date of randomization for     treatment until subjective tumor progression or death. Progression will be subjectively     defined by the treating physician, and is expected to be based on tumor marker levels (e.g.     CA-125) and/or imaging. Secondarily, we will also define PFS and OS from the date of     debulking surgery.      Patients will be stratified into (1) platinum-resistant, based on progression during adjuvant     chemotherapy or detectable disease at the conclusion of adjuvant therapy or (2)     platinum-sensitive, with no evidence of disease (NED) at the conclusion of adjuvant therapy     (per elevated blood CA-125 and/or tumor markers and/or detection of disease by physical     examination or imaging).      Summary of Stratification and Treatment Plan Platinum Sensitive Platinum Resistant     Ovapuldencel-T Arm Ovapuldencel-T + Paclitaxel Ovapuldencel-T+ Secondary Adjuvant therapy MC     Arm Mononuclear cells + Paclitaxel Mononuclear cells + Secondary Adjuvant therapy   "
95692|NCT02033603|"     Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the     knee which is increasingly performed as the population ages. It is a painful surgery and one     of the methods to reduce post-operative pain is performing a regional anaesthesia technique.     The current practice is to perform a femoral nerve block (FNB) which blocks the nerves     supplying the knee joint and the thigh muscles (quadriceps). This provides effective     analgesia. However, it also results in weakness of the quadriceps and may result in falls     post-operatively.      Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is     hypothesised to provide as effective analgesia, with less quadriceps weakness compared to     FNB, hence potentially reducing the risk of falls post-operatively.      Investigators aim to study if the analgesia provided by ACB is as good as FNB while     preserving quadriceps strength.   "
95693|NCT02033590|"     The objective of this study is to prospectively observe clinical and economic outcomes with     the use of SERI® in direct-to-implant breast reconstruction.   "
95694|NCT02033577|"     Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass     operation) gives better results on body weight in the superobese. We do not yet know whether     it is beneficial to exclude more of the proximal small bowel or more of the distal. Side     effects of bypassing can also be different.      Study aims at clarifying possible differences in effects and side-effects of these two     surgical-technical variations.   "
95695|NCT02033564|"     The purpose in this study is to determine whether there is a difference in the incidence of     postoperative sore throat when using the GlideScope™ versus a traditional intubation blade     involving patients that are not anticipated to have a difficult airway.   "
95696|NCT02033551|"     This is an extension study to evaluate the safety of Veliparib monotherapy or in combination     with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI)     in subjects with solid tumors.   "
95697|NCT02033538|"     Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and     safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in     neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was     to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound     paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell     carcinoma.   "
95698|NCT02033525|"     The present proposal has the objective to assess whether the addition of autologous ex vivo     expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury     rehabilitation program is contributing in creating the proper healing environment for the     meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of     the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The     conduction of this clinical trial will, in addition of having the aim of improving the     patient's quality of life, contribute to consolidate an emerging new type of therapy which is     still under development.   "
95699|NCT02033512|"     There is a dilemma and a permanent debate about side effects on drugs administered orally.     The first-pass metabolism is related with many side effects, since the metabolites of these     compounds affect the course of human physiology. Conventional hormone therapy by oral route     has been used for relieving menopausal symptoms. Transdermal estrogens have not been used     extensively in Brazilian women with menopausal symptomatology, however; recently a previous     long term study has indicated no increased risk breast cancer or vasomotor disorders in     menopausal women, using transdermal HRT.   "
95700|NCT02033499|"     For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin,     decisions regarding self-monitoring of blood glucose (SMBG) are unclear. SMBG testing is a     resource intensive activity without firmly established patient benefits. While SMBG holds     great promise for sparking favorable behavior change, the potential for no benefit or even     patient harm must be acknowledged. Possible negative effects on patient quality of life must     be more closely examined along with the speculative benefits of SMBG in non-insulin treated     T2DM. Among studies examining this issue a general consensus is evolving; while SMBG may or     may not be useful, its value can only be fully appreciated when the SMBG results are provided     to patients in a useful manner. The overarching goal of this proposal is to assess the impact     of three different SMBG testing approaches on patient-centered outcomes in patients with     non-insulin treated T2DM within the real-world, clinic setting. In this pragmatic trial, 450     patients will be randomized to one of the following three SMBG testing regimens: 1) no SMBG     testing, 2) once daily SMBG testing with standard patient feedback consisting of glucose     values being immediately reported to the patient through the glucose meter, and 3) once daily     SMBG testing with enhanced patient feedback consisting of glucose values being immediately     reported to the patient PLUS automated, tailored feedback messaging. The first two arms     represent common SMBG testing approaches. The third arm is an enhanced, patient-centered     approach to SMBG testing. SMBG values will be evaluated at routine clinic visits over 52     weeks.   "
95704|NCT02033447|"     Men with early prostate cancer face a number of options which lie at the extremes of care. On     one hand, active surveillance involves monitoring the disease and on the other, immediate     treatment involves surgery or radiotherapy. The difference between these two strategies in     terms of reducing the chance of a man dying from his disease is small. Not only is the     benefit small, surgery or radiotherapy carry significant side-effects. These occur because of     damage to surrounding tissue resulting in incontinence of urine (1 in 5), erectile     dysfunction (1 in 2) and back-passage bleeding, diarrhoea or discomfort (1 in 10).      The investigators have been working on new forms of treatment that use heat, light or cold to     destroy tissue and minimise treatment-related harms. The investigators have not yet found one     that delivers the ideal treatment. The ideal treatment is one that can be done under local     anaesthetic, can effectively destroy areas of cancer, limit damage to surrounding tissues, is     repeatable, and adaptable to future discoveries such as molecular targeting of cancer cells.      The investigators think magnetic thermoablation may be able to deliver on these ideal     attributes. Magnetic thermoablation involves injecting magnetic iron nanoparticles directly     into the cancer. When a magnetic field is applied close to them, these nanoparticles heat up     to very high temperatures that kill cells. Magnetic thermoablation does not use x-rays or     surgical incisions. The investigators have done a lot of the preclinical work already to     develop this type of treatment. The investigators now need to develop a system that can be     used to treat prostate cancer. However, before the investigators can do this, they need to     test whether the magnetic nanoparticles actually stay where they are injected. The     consequences of them moving to areas that they should not can be serious. First, the     nanoparticles could move away from the cancer which means the cancer will not be heated     effectively. Second, the nanoparticles could move to sensitive structures around the prostate     (back-passage, bladder, sphincter muscle controlling urine flow, nerves controlling     erections). If this happens, damage of those sensitive structures could occur leading to     side-effects.      The investigators propose a study to try and find out what happens to those nanoparticles.     The study will involve approaching men who are having their prostates removed by radical     surgery. If these patients agree to participate, the investigators will inject their prostate     with varying amounts of nanoparticles. The investigators will NOT heat them up. The     investigators will use special scans and, once they have had their surgery, to look at the     pathology specimens to see where the nanoparticles have gone. The actual nanoparticles are     not harmful but the process of injection can carry a small amount of harm. If the     nanoparticles stay where they are injected, the investigators will then be able to run     another study in which we treat men who have prostate cancer with magnetic thermoablation.   "
95705|NCT02033434|"     The investigators hypothesize that intra-nasal ketamine, for analgesia of patients with     moderate to severe pain in an alpine setting, will provide a clinically significant reduction     in pain and provide an effective and feasible alternative to intravenous opioids.      The investigators wish to know:        1. Is our study protocol feasible to study INK in a mountain, prehospital care environment?        2. What estimate can be made of recruitment rates?        3. Does studying the use of INK interfere with or delay care at Whistler/Blackcomb?        4. Is intra-nasal ketamine an effective and safe method for controlling pain in our study          population and setting?        5. Does intranasal ketamine provide a clinically significant reduction in pain or do          patients require additional IV narcotics for extraction?        6. Are there any significant changes in vital signs after administration of intra-nasal          ketamine        7. Does the use of intra-nasal ketamine reduce time of patient extraction and transport in          the alpine pre-hospital setting?        8. Are there any long term sequelae of INK at one week?   "
95706|NCT02033421|"     The recommended length of antibiotic treatment to patients with infective endocarditis is 4-6     weeks. All patients receive the same dosis except for those with renal impairment who receive     a smaller dose. For Beta-lactam antibiotics, a plasma concentration above the minimal     inhibitory concentration (MIC) for at least 50% of the time in a dosing interval maximize     bactericidal activity. To estimate the time for which the antibiotic concentration is above     the MIC (T>MIC) and to see if there might be a relationship between the concentration of     antibiotics and possible side-effects, toxicity and treatment failure, all patients admitted     with infective endocarditis will be followed and have two blood tests withdrawn once a week     during antibiotic treatment, an expected average of 5 weeks.   "
95707|NCT02033408|"     the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut     microbiome. The results of previous studies on the effectiveness of antibiotics and fecal     macrobiota transplantation (FMT) are contradicting.      Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe     colitis in an addition to standard corticosteroid therapy (UC and isolated UC-like Crohn's     colitis). The secondary aim is to assess the outcome of FMT in those not responding to five     days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant     disease to at least two immunosuppressive medications, may be treated with either     interventions.   "
95708|NCT02033395|"     This observational study follows subjects who have been exposed to a traumatic event and are     at risk of developing PTSD symptoms. Participants are recruited within six hours of a     traumatic event, and, starting from the recruitment session, are then examined on six set     points of time within a period of thirteen months. The examinations include both biological     studies of cortisol in hair, blood and saliva, and psychological examinations and     questionaires that assess the development and severity of PTSD symptoms.      The novel method of sampling hair cortisol allows investigators to retroactively estimate the     mean levels of blood cortisol during the tree months prior to the sampling.      The study aims at further illuminating the correlation between cortisol levels both prior and     following a traumatic event, and the development and severity of PTSD symptoms   "
95709|NCT02033382|"     This study will identify and evaluate relevant biomarkers and structural brain imaging for     understanding potential biological illness related mechanisms in medication-naïve subjects     with early psychosis before and after initiation of antipsychotic medication   "
95710|NCT02033369|"     This study aims to determine whether ventral striatal dopamine release is a mechanism of     reward motivation in major depression, whether dopamine release is low in depression, and     whether DA release and reward motivation predict response to dopamine-targeted treatment with     pramipexole.   "
95711|NCT02033356|"     The aim of this prospective dose finding study is to estimate the minimal effective volume     (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal     block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use     an MRI scan to evaluate the main objective and ensure spread to the distal part of the     adductor canal.   "
95712|NCT02033343|"     The purpose of this study is to monitor movement of the prostate during radiotherapy and     adjust the radiation beam to account for any motion seen. This will increase the radiation     dose to the prostate and decrease the dose to the rectum and bladder.   "
95713|NCT02033330|"     In this study, the bioavailability of a specific orange peel extract is tested. The     composition and morphology of the test product is altered compared to the generic product,     which is used as a control. Due to intellectual property issues, more information cannot be     given at this moment. Also the difference in bioavailability between a capsule and a lozenge     is tested. The hypothesis is that the bioavailability of the altered extract will be improved     compared to the control.   "
95714|NCT02033317|"     This study assessed the pharmacodynamic effects of patiromer on serum potassium in     participants on hemodialysis.   "
95716|NCT02033291|"     Cerebral small vessel disease (cSVD) encompasses all pathological processes that affect the     small vessels of the brain. On brain-MRI cSVD is characterized by structural brain     abnormalities such as white matter lesions (WMLs). Clinically, cSVD is related to acute     syndromes as lacunar stroke but also to more chronic health problems such as cognitive     decline. Recent literature suggests that a disrupted blood brain barrier (BBB), leading to     elevated BBB permeability, may play a pivotal role in the aetiology of cSVD and lacunar     stroke. The BBB is a complex system of neuronal, glial and vascular cells which main function     is to shield the brain from toxic components and regulate the homeostasis. Elucidating the     role of the BBB may have far reaching consequences for the treatment of cSVD patients and the     reduction of recurrence rate of the disease. This could lead to a better quality of life     among cSVD patients and reduce the economic burden on society. Currently the exact     contribution and extent of a possibly defective BBB in cSVD remains largely unclear, due to     the lack of a reliable method to accurately quantify the BBB permeability in cSVD patients.     As a result, the current treatment consists of treating the cardiovascular risk factors,     often with poor results.      Quantification of the BBB permeability provides an objective measure of the integrity of the     BBB and as such aids the study of the role of the BBB. The aim of this study is to realize a     clinically applicable MRI-method to quantify the BBB permeability. Moreover, the method can     be used to study the involvement of BBB disruption in other neuropathologies including     Alzheimer's disease, vascular dementia, hypertension and diabetes.      Primary Study Objective:      To realize a clinically applicable quantification of BBB permeability using DCE-MRI by     determining the reproducibility of the DCE-MRI method      Secondary Study Objective:      To achieve the shortest scan duration without compromising the reliability of the BBB     permeability quantification.      Hypotheses:        1. Using an optimized DCE-MRI method to quantify the BBB permeability, the BBB permeability          can be reliably determined in cSVD patients.        2. The scan duration can be shortened without compromising the reliability of the BBB          permeability quantification.   "
95717|NCT02033278|"     Clinical trial phase II-III, double-blind, randomized, controlled with placebo. There is     sufficient preliminary evidence to consider intracoronary injection of bone marrow progenitor     cells as a viable, safe and beneficial treatment in patients with dilated cardiomyopathy,     although the biological mechanism of action of bone marrow cells in the myocardium is not     known. In this project we propose to investigate comparatively and from a biological and     clinical point of view the applicability of regenerative therapy with autologous bone marrow     cells in patients with dilated cardiomyopathy.   "
95747|NCT02032875|"     This trial was open to participants who had received a liver transplant or had cirrhosis due     to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were     followed for 24 weeks post treatment. Under certain conditions, the treatment duration could     have been extended for cirrhotic participants. The study tested the efficacy and safety of     this combination for treatment of HCV in cirrhotic and post transplant patients.   "
95718|NCT02033265|"     Axillary brachial plexus block (freezing the nerves in armpit) is commonly performed as a     primary anesthetic technique for the elbow/ forearm or hand surgery. These nerves are     identified using ultrasound and nerve stimulator (by stimulating the nerves using a small     current through the needle). Axillary brachial plexus block has been shown to result in     better pain relief, less nausea, vomiting and early discharge from hospital. The use of these     nerve blocks have also shown to decrease the duration of hospital stay, decreased side     effects of opioids painkillers and better satisfaction scores over the conventional use of     intravenous and oral pain medications. These beneficial effects are particularly useful for     patients who are overweight or obese. A study by Hauouz et al published in Anesthesia and     Analgesia in July 2010 suggests that the success rate of brachial plexus block is lower for     obese and overweight patients. However, ultrasound guidance was not used for performing     axillary brachial plexus block in this study. We propose that with usage of ultrasound     guidance the success rate of brachial plexus block will be similar in obese and non-obese     patients.      In this study, we want to compare the success rate of axillary brachial plexus block for     obese and non-obese patient groups. We would also like to look at performance time,     complications and patient satisfaction for our study population.   "
95719|NCT02033252|"     This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture     therapy on persistent allergic rhinitis patients complicated with asthma.   "
95720|NCT02033239|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting     insulin aspart (FIAsp) in subjects with type 1 diabetes.   "
95721|NCT02033226|"     The objective of this study is to evaluate the anti-inflammatory and anti-infective     properties of amniotic membrane (AM) when used for guided tissue regeneration (GTR) in     periodontal bone defects.   "
95722|NCT02033213|"     An exploratory single-centre randomized clinical trial was performed in order to investigate     whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary     gas exchange and tissue perfusion.   "
95723|NCT02033200|"     The purpose of this study is to see if Stendra causes any changes in vision, eye pressure,     pupil dilation, and color vision in healthy males.   "
95724|NCT02033187|"     Healthcare-associated infections are a major cause of morbidity among critically ill     patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum     antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections.     The purpose of this study is to evaluate the effect of daily bathing with disposable     chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable     standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated     infections in critically-ill patients.      Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will     result in reduced rates of healthcare-associated infections in patients admitted to intensive     care units (ICU).   "
95725|NCT02033174|"     Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will     decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in     healthy people after a five days period.   "
95726|NCT02033161|"     This pilot-study aims to evaluate the treatment effects and feasibility of an     internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.   "
95727|NCT02033148|"     This phase I trial studies the side effects and best dose of icotinib hydrochloride in     treating patients with advanced cancers. Icotinib hydrochloride may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
95728|NCT02033135|"     This randomized clinical study is intended to evaluate the use of Zilver PTX stents for     treatment of thigh atherosclerosis.      Research question: Is there an adjuvant benefit of angioplasty and stenting using the new     paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone     in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal     lesions suitable for endovascular management.   "
95729|NCT02033122|"     Exercise training has been proposed as adjunctive therapy in asthma to improve many clinical     outcomes; however its effects on bronchial hyperresponsiveness (BHR) and inflammation,     characteristic features in asthma, remains poorly understood. We aim to investigate the     effects of aerobic training on BHR (primary aim) and systemic inflammation (secondary aim).     In addition, clinical control and health related quality of life (HRQoL) will be also     assessed.   "
95730|NCT02033109|"     This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse     transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the     prevention of HIV infection in women. This is the first in-human of PC-1005 (MIV-150/zinc     acetate in a carrageenan gel), the first study in which females will be exposed to MIV-150,     the first time MIV-150 will be administered topically, and the first time MIV-150 will be     administered intravaginally.   "
95731|NCT02033096|"     Follow-up, Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202   "
95732|NCT02033083|"     Primary objective: To study the difference in dilation and evacuation (D&E) procedure time     following overnight cervical preparation with laminaria or Dilapan-S™. The investigators     hypothesize procedure time will be less with Dilapan-S™.      Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1)     initial cervical dilation before D&E; (2) need for mechanical dilation to accomplish D&E and     ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete     the D&E procedure without further cervical preparation; (5) complications; (6) pain and other     side effects; (7) patient acceptability; and (8) provider acceptability.   "
95733|NCT02033070|"     The purpose of this study is to provide a tool for physicians to compare outcome data related     to the use of the HALO Ablation Systems. This study is a single-center patient registry which     will contribute to a framework for treatment and follow-up of patients with Barrett's     Esophagus.   "
95748|NCT02032862|"     Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application     over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot     flushes daily and a Hyperhidrosis Scale score ≥ 2   "
95734|NCT02033057|"     Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or     neuropathy which difficulties both the process of extubation and the functional recovery. The     objective of this project is to analyze the effect of muscle electrostimulation (ESM) on     muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a     single center, prospective, randomized trial to be held in the ICU of  Universitarian     hospital La Fe in collaboration with the service of Neurophysiology of the hospital. All     patients undergoing sedation and mechanical ventilation (with an expected duration longer     than 48h) and without any of the exclusion criteria detailed in the Methodology section will     be included in the study. The intervention will consist of a muscular electrostimulation with     the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5     per side) following established protocols, at least 5 days a week. We will evaluate muscle     strength by Medical Research Council scale, functional capacity by Barthel scale and     Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic,     echographic and histologic parameters will be measured. The process of extubation will be     performed following an established protocol, the duration will be collected as the same     manner as ICU.   "
95735|NCT02033044|"     Study design was a multicenter, randomized, rater-blind clinical trial. There were     two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific     cognitive rehabilitation group intervention (CR) compared with a psychoeducational group     intervention (PE) in subjects with Borderline Personality Disorder (BPD).   "
95736|NCT02033031|"     Retinal vein occlusion (RVO) is the second leading cause of retinal vascular disease in     patients older than 50 years.The prevalence varies from 0.7% to 1.6% in the literature.      Visual recovery depends on ischemic damage of the retina, the occurence of macular edema (ME)     and the development of neovascular glaucoma. The occurence of ME is the main reason for     visual loss and frustrates visual recovery among patients with both central or branch RVO.      Therapeutic options that have been used and discussed over the years are the treatment with     anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution.     Furthermore, surgical options like vitrectomy and radial optic neurotomy were used.     Panretinal photocoagulation and grid pattern photocoagulation had established as additional     tool to induce chorioretinal anastomosis. Nevertheless, the effectiveness and the evidence of     these different treatment options could not be verified and remains mostly unknown.      Nowadays, intravitreal anti-VEGF application had become the treatment of choice for ME     secondary to RVO. Multi-center studies have already shown the effectiveness of anti-VEGF     treatment to reduce intraretinal fluid and retinal hemorrhages (BRAVO, CRUISE).     Unfortunately, often high numbers of re-treatments become necessary over the years. In our     knowledge, there are no reports showing more than 3 years treatment effects of antiangiogenic     drugs in patients with BRVO. However, the results of treatment effect longer than 3 years are     important, as the mean age < 70 years with an onset of BRVO has been estimated in about 60%     of all cases. In addition, most patients with regard to the application of anti-VEGF     treatment in real clinical setting, there is only rare experience concerning need of optimum     time duration for follow-up at the departments. Hence, the present study aimed to evaluate     the long-term clinical outcomes, safety and therapeutic benefit of a flexible dosing regimen     of intravitreal anti-VEGF therapy in patients with ME secondary to BRVO.   "
95737|NCT02033018|"     The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal     injections (IVT) in CNV secondary   "
95738|NCT02033005|"     Breast feeding is believed to be beneficial to long-term health but how these effects are     mediated is unknown. I suggest that this may be through effects on body composition and     metabolism.      I will compare adipose tissue and liver fat deposition in healthy, full term breast and     formula fed infants babies shortly after birth and around 12 weeks.   "
95739|NCT02032979|"     The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles     of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2     FSHD study. For this, the investigators relied on observational components: FSHD2 patients     appear more often present with psychiatric comorbidities and seem to have lower cognitive     performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small     sample population of patients. It seems to exist mainly executive dysfunction associated with     attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low     in relation to their socio-educational and compared with patients FSHD1 level.   "
96013|NCT02029417|"     This phase II trial studies the side effects and how well omacetaxine mepesuccinate,     cytarabine, and decitabine work in treating older patients with newly diagnosed acute myeloid     leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth.   "
95740|NCT02032966|"     Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an     ankle fracture in which both the tibia and the fibula are broken. This would alleviate the     need for another incision, plate, and screws to repair the fibula. The purpose of this study     is to help determine if surgically repairing only the tibia fracture will lead to equivalent     clinical outcomes when compared with surgical repair of both bones.      The hypothesis of this study is that operative stabilization of the medial malleolus fracture     only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the     ankle, will lead to equivalent clinical outcomes and functional scores as those treated with     operative stabilization of both malleoli and/or all malleoli.   "
95741|NCT02032953|"     The purpose of this study is to find out whether adding insulin after current colorectal     cancer surgery promotes making and keeping proteins in the body, and to find out whether or     not this effect can be further increased by increasing the amount of protein given.   "
95742|NCT02032940|"     The purpose of the study is to create MR images using an investigative technique called pulse     sequences with new computer software programs. The sequence will allow us to image vessels     without injecting contrast agents.   "
95743|NCT02032927|"     Osteoarthritis is a common joint disorder in the elder population.The current treatment     options include both a non-pharmacological approach (physiokinesitherapy, diet) or if this     fails, a pharmacological approach that relies in the first instance on drugs such as     paracetamol, non-steroidal anti-inflammatory (including inhibitors of cyclo-oxygenase).     However, the use of these drugs is limited, by the roof effect concerning analgesia, and by     the potential side effects. When pharmacological treatments with non-opioid medications fail,     and a moderate-to-severe pain reduces the quality of life of the patient, international     guidelines suggest the use of opioid drugs.   "
95744|NCT02032914|"     Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions,     the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not     evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of     cryptogenic pyogenic liver abscess by colonoscopic examination.   "
95745|NCT02032901|"     To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus     (HCV) Genotype 3 infection   "
95746|NCT02032888|"     A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the     treatment of hepatitis C virus and HIV coinfection.   "
95752|NCT02032810|"     The purpose of this study is to find out if an investigational drug called panobinostat can     be given safely with another drug called ipilimumab. Investigators want to learn more about     the side effects of this combination of drugs using different doses of panobinostat and the     same dose of ipilimumab.   "
95753|NCT02032797|"     The aim of the study is to determine whether 5 or 7 days of progesterone supplementation     before transfer of a day 5 cryopreserved thawed embryos in an artificial cycle results in a     significant higher pregnancy rate.   "
95754|NCT02032784|"     Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or     ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.   "
95755|NCT02032771|"     Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of     3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their     facial skin appearance.      Hypothesis: The SST will improve the appearance of the wrinkles/elastosis and/or pigmentation     by at least 1 on the FES scale or ≥50% in category scale at 3 months follow-ups in at least     50% of the study population.   "
95756|NCT02032758|"     The investigators will investigate golfers with visual evidence of an involuntary movement     while putting before and after treatment with a low dose of propranolol.   "
95757|NCT02032745|"     A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based     chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively     evaluate the microarray-based, genomic test as a predictor of axillary lymph node response.     Also, to determine whether the probability of achieving negative axillary nodes, is     sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to     support omitting axillary dissection.   "
95758|NCT02032732|"     Pediatric joint infections are a common diagnostic dilemma encountered by treating     orthopaedic surgeons. No single test is sensitive or specific enough to stand alone in     determining the presence of joint infection.      The purpose of this study is to test the usefulness of a chemical test strip to detect     infection in fluid that is removed from a joint (intra-articular aspiration) in pediatric     patients. The test strip measures an enzyme called leukocyte esterase, which has been shown     to be useful in detecting the presence of infection in fluids from other parts of the body.     This study will assess the efficacy of the leukocyte esterase test as a diagnostic tool for     evaluating pediatric joint infections. The hypothesis of the study is that a positive     leukocyte esterase test identifies a septic joint in pediatric patients undergoing     intraoperative joint aspiration.   "
95759|NCT02032719|"     Patients who receive smartphone-assisted health coaching will have a significantly lower 24     hour ambulatory blood pressure mean than patients who receive just health coaching   "
95760|NCT02032706|"     The purpose of this study is to assess the accuracy of Night Shift in the detection of supine     sleep and efficacy of vibro-tactile feedback in restricting supine sleep.   "
95800|NCT02032186|"     The investigators propose a preventive strategy that may reduce the risk of placental     vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or     stillbirth)and mother (e.g., the hypertensive disorders of pregnancy), and which, in turn,     should reduce the need for indicated preterm delivery. This strategy is a multicenter,     randomized double-blind, placebo-controlled clinical trial (RCT) comparing magnesium citrate     supplementation with placebo, each starting at 12 to 20 weeks gestation and continued until     delivery. Magnesium citrate is a safe and inexpensive compound that is easily absorbed by the     intestinal tract. The results of this RCT may be especially relevant in low and middle income     countries that have high rates of prematurity, and limited resources for acute newborn and     maternal care.   "
95801|NCT02032173|"     To evaluate a new treatment regimen with a spaced out follow-up after an initial intensive     treatment phase in patients with reduced visual acuity due to diabetic macular edema (DME).   "
95761|NCT02032693|"     The investigators are conducting this research because they want to determine if a dietary     supplement, called Everycell™, has an effect on the functioning of the study participants'     cells. The results of this research will be used to help develop additional strategies for     trying to fight the effects of aging. The primary purpose of this study is to determine the     effectiveness of Everycell™ compared to placebo (a pill that does nothing) on DNA damage,     inflammation, stress, and related factors. Taking Everycell™ is not a medical prescription,     treatment, or cure for any known disease or condition.      Helping patients' nutritional status is important to prevent the continued worsening of     chronic diseases and also to counteract the effects of aging. Americans also have     difficulties with compliance to prescription medications due to their toxicity and side     effects. This study aims to learn more about how a dietary supplement may improve nutritional     status and enable the body to normalize cellular functioning, which may improve quality of     life. The results of this research will be used to determine if Everycell™ is beneficial for     overall cellular health and to counteract the effects of aging.   "
95762|NCT02032680|"     As specified in the VA Uniform Services Handbook, Family Psycho-Education (FPE) treatment     must be available to all Veterans with schizophrenia who could benefit, and their family     members. This includes those receiving care at Community Based Outpatient Clinics (CBOCs),     and at Psychosocial Rehabilitation and Recovery Centers (PRRCs), whether provided on site, by     referral, or by telemental health. However, less than 5% of VA medical centers offer FPE.     Clearly, a major challenge is to devise ways to deliver mental health treatments and services     to Veterans who need them in ways that meet their needs and preferences. The proposed project     will compare the use of a website to deliver FPE to that of in-person delivered FPE. The     findings could have profound implications for the VA's ability to improve the reach, use,     appeal, and effectiveness of FPE for Veterans with schizophrenia, by using an e-health model     that facilitates family involvement.   "
95763|NCT02032667|"     This study will be investigating an innovative and exciting way to increase physical activity     in children between the ages of 9 and 12 years old. Families will be provided with a     state-of-the-art exercise bike and video game console to have in their homes. The video games     will provide a variety of play including racing, puzzle solving, collaborative play, team     play and competitive play. We will be comparing whether a 'multi-player' condition has a     greater adherence compared to a 'single-player' condition.   "
95764|NCT02032654|"     Cellulitis is among the most common infections leading to hospitalization, yet the optimal     duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of     antibiotics, which is the current standard of care. Recently it has been shown that     antibiotic treatment for pneumonia and urinary tract infections can safely and significantly     be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis     with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no     difference in outcomes when patients hospitalized with cellulitis are treated with either a     short-course (6 days) or standard-course (12 days) of antibiotics.   "
95765|NCT02032641|"     The purpose of this study is to determine the efficacy of the 1064nm Neodymium yttrium     aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar     after direct brow lift.   "
95766|NCT02032628|"     Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators     will demonstrate a dose-response relationship between volume of aerobic exercise and changes     in DNA methylation over four months among previously sedentary women.      Specific aim 2. There are no published data on the extent to which positive effects of     exercise on methylation might decay if exercise is not continued. The investigators will     gather data on the natural history of methylation decay after training.   "
95767|NCT02032615|"     To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of     anemic subjects longitudinally.      To quantify the demographics of subjects attending anemia testing camps through LBWR and to     explore correlations with the demographics data.   "
95768|NCT02032602|"     Background: Non-specific shoulder pain has a high prevalence in older adults and provokes     functional alterations. Besides, there are difficulties for its clinical diagnosis, lack of     effectiveness in the treatment and not much evidence is found regarding invasive physical     therapy techniques in this population.      Purpose: To determine the efficacy of a single physical therapy intervention with deep dry     needling on latent and active myofascial trigger points in older adults with non-specific     shoulder pain.      Methods: Pilot Study, Single Blind Randomized Controlled Clinical Trial on 60 subjects aged     65 and over, will be diagnosed with nonspecific shoulder pain. The study will be approved by     the Clinical Research Ethics Committee of the area. Sample will be recruited at their home     and at a care center, and randomly will be distributed in Experimental Group (n=30), which     will be received a session of Deep Dry Needling on an active and a latent Myofascial Trigger     Points of the infraspinatus muscle; and Control Group (n=30), receiving a session of Deep Dry     Needling only on an active Myofascial Trigger Point. A blind examiner will be evaluated Pain     Intensity, Pain Pressure Threshold (anterior deltoid; extensor carpi radialis brevis) and     Grip Strength, before, immediately after intervention and after a week of treatment.   "
95791|NCT02032303|"     Study design Investigators aim to perform a prospective, single-center,     investigator-initiated, randomized study to compare the Adenosine-induced coronary     vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous     Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary     Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive     a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation     myocardial infarction these drugs will be administered only when the coronary anatomy will be     known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass     grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In     patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be     administrated before the procedure, according to the European Society of Cardiology     guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler     Flow Wire before the stent implantation and after the procedure at baseline and 2-minute     later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140     ug/Kg/min with 2 minutes interval between infusions.      Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to     maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio     between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in     patients with acute coronary syndrome, without an increased risk of adverse events for     patients neither adjunctive costs for the National Health System.      Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will     be measured in venous blood collected at the end of the procedure. . In patients requiring a     second Percutaneous Coronary Intervention, for example for multivessel disease, all these     measures will be repeated in the same manner.   "
95769|NCT02032589|"     Past research has shown that items self-generated by an individual, such as words or     concepts, are remembered better than items that are simply read or heard. The current study     seeks to demonstrate the effectiveness of using the principles of the generation effect in a     treatment intervention to improve memory and functional performance in individuals with     Multiple Sclerosis who have learning and memory difficulties.The main purpose of the study is     to conduct an experimental investigation on the effects of a self-generation strategy     treatment, embedded within practice of various activities ranging from laboratory tasks (e.g.     words and concepts) to functional tasks (e.g. activities of daily living). The treatment to     be tested is geared toward helping patients selfdiscover their own strengths and abilities     while using self-generation to be able to utilize it independently in everyday life     situations.      Design: The proposed pilot study is a randomized clinical trial. Participants: Participants     will include forty (40) persons with MS, between the ages of 18 and 65, who demonstrate     memory impairments. Half of the participants will receive the self-generation training while     learning different types of tasks (experimental group) and half of the participants (control     group) will be asked to learn the same information but will receive a conventional practice     (e.g. repetitions).      Expected results: We expect that participants undergoing the self-generation-training     intervention will show better memory performance, functional performance, quality of life,     and satisfaction with treatment and life compared to participants in the control condition.   "
95770|NCT02032576|"     Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive     therapy (ECT) response. Although ECT is highly effective for treatment of patients with major     depressive episode, a high rate of relapse/recurrence is a major problem after     discontinuation of ECT. The purpose of this study is to examine the factors related to the     response of ECT, to predict ECT response early, and to investigate the clinical predictors     affecting the time to relapse/recurrence after ECT.      Methods: Patients with major depressive episode who require ECT treatment will be enrolled.     ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17)     and other scales will be assessed before ECT, after every 10 days, till to an expected     average of 50 days, and monthly during the 6-month follow-up period. Other measures also will     be performed before the first ECT, at an expected average of 50 days, and at the end of     follow-up period. Predictors of the response and relapse/recurrence after ECT and early     prediction of ECT response will be obtained by statistic methods.   "
95771|NCT02032563|"     We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after     neoadjuvant therapy (chemo- or hormonotherapy)   "
95772|NCT02032550|"     The purpose of this study is to develop a preference based decision aid to assess the     treatment preferences of prostate cancer patients, and to analyze the interaction of     treatment preferences, type of treatment received and their relationship with health related     quality of life, satisfaction with care, decision regret, and psychological health of men     with localized prostate cancer.   "
95773|NCT02032537|"     Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced     chronic kidney disease (CKD) and end-stage renal disease (ESRD).      Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli     pharmaceutical company developed a topical cream based on active plant extracts for treatment     of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled,     randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort     of CKD and ESRD patients.   "
95774|NCT02032524|"     Primary Objective:      Long-term safety and pharmacokinetics (PK) of neoGAA      Secondary Objective:      Long-term effect of neo-GAA on pharmacodynamic and exploratory efficacy variables   "
95775|NCT02032511|"     This study is designed to compare the effectiveness and ease of use of two commonly used     NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.   "
95815|NCT02031991|"     This study is to prove that the handling (also referred to as pharmacokinetics) of the     following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United     States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is     similar in healthy male volunteers after receiving a single intravenous dose of either drugs.      During the course of the study, the similarity in pharmacokinetics will be assessed by     sampling the levels of drug in the blood, and by comparing these levels among the different     administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability,     and immunologic response to the administered drugs will also be evaluated throughout.   "
95776|NCT02032498|"     The revision of our data shows that since its introduction in our institution (Jules Bordet     Institute) in 1998 (until 2010, the year of the last review of cases), 53 patients underwent     neoadjuvant therapy before selective sentinel lymph node dissection followed by conventional     axillary dissection.      The analysis of these cases shows that:        -  The lack of demonstration of sentinel lymph nodes observed in 8 cases (6 cN0) is          associated in 75% of them with a pN+ status        -  If scintigraphic imaging is positive (demonstration of the sentinel lymph nodes: 35          cN0 and 10 cN+), our results appear favorable with a single false negative SLN result          (False Negative Rate = 1/20 or 5%).      Therefore we propose additional technique for LN detection by indocyanine green, we     hypothesize that the combination of two different injections improves the technique of     sentinel lymph node biopsy.   "
95777|NCT02032485|"     The purpose of this study is to determine if Near-Infrared fluorescence imaging is an     effective approach to detect the colorectal tumoral tissues and peritoneal implants in     colorectal cancer patients.   "
95778|NCT02032472|"     Background: Hypertension in adults is the factor most prevalent cardiovascular risk and     motivates further inquiries, generating a very high cost of medical care.      Objective: To evaluate the monitoring of well-controlled hypertensive patients Pharmacy     Offices. Hypothesis: the monitoring of these patients through the Office of Pharmacy will be     as effective in obtaining good control of blood pressure as it is to obtained through health     centers. Design: Multicenter randomized controlled trial along one year of follow up.     Location: the city of Cerdanyola del Vallès (Barcelona). Participants: All patients diagnosed     with hypertension and good control criteria in the past year. Arms: Health centers (control)     and Pharmacy Offices (intervention). Outcome variable: blood pressure under good control     along the monitoring   "
95779|NCT02032459|"     Vitamin D is present in food either naturally or by fortification and included in nutritional     supplements. It is also synthesized photochemically by the skin from ultraviolet B radiation.     Vitamin D synthesis varies by season and with latitude as well as according to intensity of     skin pigmentation. Recent research in the United States found lower circulating levels of 25     (OH) D, the primary indicator of vitamin D status, among minority women who were either     pregnant or in their reproductive years. The extent to which maternal vitamin D has an     influence on the course and outcome of human pregnancy remains to be more completely studied.     We propose to use the HPLC method to assay cholecaliferol (vitamin D3) and ergocalciferol     (vitamin D2) to assess maternal vitamin D status. This will be accomplished by analyzing     existing fasting samples and data derived from the 2001-2006 cohort (N=1141) of young, low     income minority gravidae from Camden, New Jersey to determine:        1. The prognostic importance of maternal vitamin D status for birth weight, gestation          duration and poor pregnancy outcomes (low birth weight, preterm delivery, fetal growth          restriction).        2. The relation of maternal vitamin D status to important complications of pregnancy          (gestational diabetes and pre-eclampsia).        3. The relationship of maternal vitamin D status to maternal diet and supplement use,          season of year, ethnicity, overweight/obesity, and other maternal characteristics.   "
95780|NCT02032446|"     MESENCHYMAL STROMAL CELLS (MSC) have shown promising albeit not always consistent therapeutic     effects in the treatment of severe steroid-resistant acute Graf versus Host Disease.     Remarkably, in all reported clinical studies the toxicity of Mesenchymal stromal cells     administration has been found consistently negligible. The investigators believe that     Umbilical Cord (UC) derived Mesenchymal stromal cells may represent a stronger     immunosuppressive tool for such clinical emergency and no data suggest any change in the     safety profile of these cells. For this reason, and in the best interest of the patient, the     investigators plan to test the safety and activity of Umbilical Cord Mesenchymal stromal     cells when given sequentially to another partially effective treatment of steroid resistant     acute graf versus host disease such as Pentostatin.   "
95781|NCT02032433|"     CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone     (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention     of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high     affinity partial agonist indicated for maintenance treatment of opioid dependence, as     pharmacotherapeutic aids to recovery.      The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment     programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or     BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72     hours after their last opioid).      The primary goal of the study is to estimate the difference, if one exists, between XR-NTX     and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence)     during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus     BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore     demographic and, clinical, and genetic predictors of successful treatment and moderators of     differential effectiveness (i.e., what variables may help clinicians choose which of these     treatments is best for a given patient).), and (3) collect a limited dataset to permit     analyses of economic costs and benefits of the two treatments.   "
95782|NCT02032420|"     Volunteers will watch a training video demonstrating how to place a needle in the correct     position while keeping it visible. Later the volunteers will be placed in front of a set up     identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk     needle into 3 targets in a standardized homemade phantom a total of three times.   "
95783|NCT02032407|"     This study will evaluate the effect of dapsone gel in female subjects with skin of color     (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.   "
95784|NCT02032394|"     This study is conducted to determine and compare the effect of applying Povidone-iodine and     Chlorhexidine solutions for perinea washing on bacteriuria rate and type in patients with     urinary catheter in intensive care unit.   "
95785|NCT02032381|"     Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of     malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric     allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to     evaluate the prevalence and course of PFT abnormalities before and after transplant, and to     detect risk factor for PC.   "
95786|NCT02032368|"     Circulating tumour cell (CTC) count could reflect the effect of postoperative transarterial     chemoembolization (TACE) on hepatocellular carcinoma (HCC) recurrence.   "
95787|NCT02032355|"     Maternal hypotension is a common side effect after spinal anesthesia for cesarean     delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and     blood pooling in blocked areas of the body respectively, are main causes of spinal     anaesthesia-induced hypotension during Caesarean delivery.      Cardiac output, which has shown to be a better predictor of organ and placental perfusion     than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the     maternal population.This is largely because of the lack of availability of accurate and     reproducible noninvasive measurement techniques. Up to now, preventing hypotension has     continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements as     markers of cardiovascular status, because these are more easily measured.      Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension     during spinal anaesthesia, would also have a positive and significant association.   "
95788|NCT02032342|"     Selective lobar blockade (SLB) is a specific technique that allows collapse of the operated     lobe during thoracic surgery while the other lobes are ventilated. It is associated with the     improvement of arterial oxygenation during one lung ventilation (OLV) for thoracic with     providing adequate surgical access. The purpose of this study is to compare the efficacy of     three bronchial blockers, namely an Arndt® wire-guided endobronchial blocker, a Cohen     Flexi-tip endobronchial blocker or a Fuji Uni-blocker, for achieving selective lobar     collapse.   "
95789|NCT02032329|"     The purpose of this study is to assess efficacy of a pre-commercial device capable of     activating both the ankle plantarflexor and dorsiflexor muscles using electrical stimulating     during treadmill-based gait training for stroke patients.   "
95792|NCT02032290|"     The administration of these drugs is realized according to the European Society of Cardiology     guidelines.      All patients will be pretreated with aspirin 300 mg orally, heparin iv to maintain an     activated clotting time of >250 sec, and a loading dose of ticagrelor (180 mg) or clopidogrel     (600 mg) immediately before the revascularization. The list of assignment to ticagrelor or     clopidogrel will be generated by a computer according to a 1:1 randomization. Primary     Percutaneous Coronary Intervention will be performed according to standard clinical practice     using femoral or radial artery Judkins approach via six or seven French heath insertion.     After crossing the target occlusive Lesion, coronary stenting will be performed based on     standard practice. Patients subsequently will receive heparin for 48 hr, aspirin 100 mg     daily, and clopidogrel (75 mg/day) or ticagrelor (90 mg twice daily) for at least 12 months.     Other adjunctive pharmacotherapy in Intensive Care Unit will be administered according to     operator discretion. All patients will provide written informed consent before entering the     study.      Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as     standard practice. Then, all the pre-, intra-, and post-procedure data patients will be     collected in a database.      Investigators aim to perform a prospective, single-center, investigator-initiated, randomized     study to compare the Adenosine-induced coronary vasodilatation after the loading dose of     Ticagrelor either Clopidogrel during the Percutaneous Coronary Intervention. Patients with     Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the     study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180     mg) or Clopidogrel (600 mg). Coronary Flow Reserve will be recorded by intracoronary Doppler     Flow Wire before the stent implantation and after the procedure at baseline and 2-minute     later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140     ug/Kg/min with 2 minutes interval between infusions.      Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to     maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio     between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in     patients with Acute Coronary Syndrome, without an increased risk of adverse events for     patients neither adjunctive costs for the National Health System.      Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will     be measured in venous blood collected at the end of the procedure. In patients requiring a     second Percutaneous Coronary Intervention, for example for multivessel disease, all these     measures will be repeated in the same manner.   "
95793|NCT02032277|"     This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of     veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant     chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.   "
95794|NCT02032264|"     To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy.     All viable blastocysts will be biopsied and cryopreserved for future transfer. After the     final embryo is cryopreserved, patients will be randomized to either the intervention group     or the control group. Patients and doctors are blinded to the randomization until study     completion. A Double Embryo Transfer (DET) will be performed with either screened or     unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in     cases where only one embryo is available for transfer.   "
95795|NCT02032251|"     This study is a randomized, double blind, controlled clinical trials assess the efficacy of     the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.   "
95796|NCT02032238|"     Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a     prospective study using Bevacizumab.   "
95837|NCT02031705|"     It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in     preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus     ablation on atrial fibrillation itself is unclear.   "
95838|NCT02031692|"     The purpose of this study is to determine whether the supplementation of vitamin D and     calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin     D deficiency/insufficiency.   "
97065|NCT02015689|"     The purpose of this study is to examine the impact of different message framing (i.e.,     communication strategies) on parents' intentions to vaccinate their infants for measles,     mumps, and rubella. We hypothesize that information specifically emphasizing various benefits     of MMR vaccination will have different impacts on parents' reported levels of intention.   "
95797|NCT02032225|"     Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leucoencephalopathy     (CADASIL) is an archetypal small vessel disease of the brain caused by dominant mutations in     the NOTCH3 receptor. Cardinal vascular lesions include deposition of granular osmiophilic     material (GOM) within the basal lamina of smooth muscle cells, progressive smooth muscle cell     loss, and fibrosis of the media. Pathogenic mutations alter the number of cysteine residues     in the extracellular domain of NOTCH3 (Notch3 ECD), leading to its abnormal accumulation in     the GOM deposits. Vascular smooth muscle cell has been identified as the primary target cell     in this disease. Pathophysiological processes leading from NOTCH3 mutations to smooth muscle     cell loss remain poorly understood.      The investigators propose to study these mechanisms by reprogramming skin cells to become     stem cells and then differentiating them to vascular smooth muscle cells.      The hypothesis of this study is that the differentiated smooth muscle cells will display the     characteristic features of CADASIL, ie, Notch3 ECD accumulation and GOM deposits.   "
95798|NCT02032212|"     Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are     otherwise known as electronic cigarettes. These may look like conventional cigarettes but do     not contain tobacco.      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or     glycerol), nicotine, water, and flavours.      This trial is to evaluate the pharmacokinetic profile of an EVP.   "
95799|NCT02032199|"     A central goal of health care is to maximize patient functioning and well-being. This has     prompted measurement of health-related quality of life (HRQOL) that encompasses physical,     psychological, and social functioning. While obese people have generally impaired HRQOL,     people seeking bariatric surgery for obesity appear to have poorer HRQOL than obese     individuals seeking non-surgical treatment or obese individuals not seeking weight-loss     treatment. HRQOL improves significantly after bariatric surgery, but often with large     individual variations in outcome. As gastric bypass is an invasive procedure with     irreversible influences on eating behaviour and possible serious adverse events, it is     important to identify potential risk factors for a poorer long-term result. In Denmark,     bariatric surgery is free of charge for patients fulfilling the Danish Health and Medicines     Authority guidelines, which until 2011 were in line with international guidelines. However,     in 2011 access to surgery was dramatically restricted and the annual number of operations     reduced from 0.9 per 1000 inhabitants (2010) to 0.2 per 1000 inhabitants (2012). The     restrictions involved a tightening of the criteria for patients without manifest obesity     comorbidities, raising lower body mass index (BMI) threshold from 40 to 50 and increasing the     lower age limit from 18 to 25 years (11). It is not known whether patients fulfilling the     tighter criteria benefit more from surgery than patients who only met the previous criteria.      This study assessed HRQOL changes associated with Roux-en-Y gastric bypass with follow-up     over an average of 22 months. The aim was to explore whether postoperative HRQOL variations     were associated with identifiable socio-demographic or clinical characteristics. In     particular, whether HRQOL changes differed for patients fulfilling the current Danish     criteria and patients only fulfilling the previous criteria.   "
95823|NCT02031887|"     The primary objectives of this trial are:        -  to show differences in the colonization of the gastrointestinal tract with the bacteria          Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the          test or a control product        -  to investigate whether there is equivalence in growth between the four different groups          of infant described above.   "
95802|NCT02032160|"     The purpose of this study is to generate an exploratory training set of data and to identify     predictive biomarkers (a measurable biological response that predicts something) of innate     and adaptive responses to immunisation of two vaccines utilizing different adjuvant     technology given according to approved schedules to healthy adult volunteers. The vaccines     are model agents selected as they match antigens but have discordant adjuvants, have a known     immunogenicity profile, assays are freely available to measure responses, and they are safe     to administer to healthy adults at the doses and schedules proposed. This study will strive     to correlate biomarker activity with observed immunological responses to vaccination and if     successful, these biomarkers could be used in early stage clinical trials to optimize     selection of vaccine candidates with a profile that will be most likely to be effective once     they are in generalized use.   "
95803|NCT02032147|"     Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy     for cancers, and may have a devastating effect on the patient's quality of life (QOL).     However,CRN was once regarded as a progressive and irreversible disease, no standard therapy     has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF)     to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been     published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective     study to test the efficacy of NGF for CRN.   "
95804|NCT02032134|"     The increasing need for blood components and the increasingly careful donor selection     procedures, make the availability of blood components very reduced, in particular for     platelets that are currently administered preferably fresh or cryopreserved, only in     emergency conditions.      Exceeding this limit through the spread of use of cryopreserved platelets in the common     clinical practice, might help clinicians to avoid wasting valuable products and face periods     of particular shortage of donors Some studies already published in the literature over the     last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved     platelets .      The main objective of the proposed study is to evaluate the efficacy and safety of platelets,     cryopreserved with DMSO using a a new method, in patients with severe thrombocytopenia.      This is the in vivo phase of a study where availability and efficacy of cryopreserved     platelets has been assessed in vitro.   "
95805|NCT02032121|"     Survivors of childhood cancer have an increased risk of death from cardiovascular disease due     to both the therapies they received while undergoing treatment and diet and lifestyle     factors. The nature of cardiovascular risk and the interaction between treatment affects and     cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as     well as measure of blood vessel stiffness (both of which are predictive of early heart     disease) in 100 pediatric cancer survivors and 100 control children. Characterization of     vascular inflammation and stiffness in long-term survivors will allow for the development of     future interventions to decrease inflammation through both pharmacologic and lifestyle     modifications.   "
95806|NCT02032108|"     Strategies to reduce the burden of diabetes in Rwanda, like in other resource poor settings,     include involving diabetic patients in their own care and targeting modifiable risk factors     through adopting appropriate dietary and lifestyle habits. According to previous research     carried out in developed countries, lifestyle modifications may have effect on the     development of diabetes and prevention of its complications.      However, direct evidence to show whether lifestyle intervention is beneficial for diabetic     patients in resources limited countries like Rwanda is an open question. Though in these     countries, access to healthy diet is claimed to be the barrier of implementation of     therapeutic lifestyle based initiatives, we hypothesize that knowledge gaps are more     important barriers than access to healthier diets and other lifestyle habits. We therefore     would like to carry out this intervention to assess the effects of lifestyle education     programs on glycemic control among people with diabetes followed up at CHUK.   "
95807|NCT02032095|"     It is intended to examine the safety and efficacy of desensitization therapy by GB-0998     (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of     pre-transplant desensitization. Patients with positive FCXM-T after performing twice double     filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.   "
95808|NCT02032082|"     Ex vivo lung perfusion (EVLP) is not a new concept and has been widely used to study lung     function in small animals. It also has been shown to be a useful technique to evaluate lungs     from donation after cardiac death (DCD) (Yeung, Thorac Surg Clin, 2009). It has been recently     demonstrated successful application of an acellular EVLP technique in optimalizing lung     function ex vivo for an extended period of time. Following 12 h of normothermic EVLP,     patients were transplanted and demonstrated immediate life-sustaining function with promising     short-term evolution (Aigner, Am J Transplant, 2012; Sanchez, J Heart Lung Transplant, 2012;     Cypel, N Engl J Med, 2011).      Lung donation obtained after carbon monoxide intoxication has been recognized as excellent     organs because of less general inflammation and less primary graft dysfunction after     procedure. In a murine model of brain dead, carbon monoxide inhalation at a low concentration     (50 to 500 parts per million (ppm)) exerts significant cytoprotection in several lung injury     models via its vasodilatation, anti-inflammatory, and anti-apoptotic properties (Dong, J     Heart Lung transplant, 2010). The carbon monoxide inhalation down-regulates pro-inflammatory     cytokines (TNF-alpha, IL-6) along with the increase of anti-inflammatory cytokine (IL-10) in     recipient serum. The inhalation significantly decreases cell apoptosis in lung grafts,     inhibiting mRNA and protein expression of intercellular adhesion molecule-1 (ICAM-1) and     caspase-3 in lung grafts (Zhou, Chin Med J, 2008).      Apoptotis and inflammatory processes may, in part, concern alveolar tissue. Research in the     field of biomarkers is now opening new perspectives with the development of non-invasive     tests allowing for monitoring inflammation and damage in the deep lung. Blood tests (Bernard,     Toxicol Appl Pharmacol, 2005) measuring lung-specific proteins (pneumoproteins) such as Clara     cell protein (CC16) and surfactant-associated proteins (A, B or D) are now available to     evaluate the permeability and/or the cellular integrity of the pulmonary epithelium. These     dosages may constitute an interesting way for monitoring the quality of the lung before     implantation.   "
95809|NCT02032069|"     Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung     transplantation, shares key clinical and pathological features with acute lung injury and its     more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung     injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung     edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft     dysfunction has been less thoroughly explored. We will try in this study de determine the     rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.   "
95810|NCT02032056|"     The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided     for 6 mo, on the prevalence of infections and allergic manifestations in small children, and     how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children     are enrolled during 2 winter seasons.   "
95811|NCT02032043|"     Approximately 4,000 people will participate per year. The study population will include     females and males over 5 years of age who live in filariasis and onchocerciasis endemic     areas. Subject selection will not be based on health status.      Two sites will be studied, and each study will last for 4 years. Participants will be studied     only once in cross-sectional surveys. Some subjects may be included in more than one annual     population survey, but this is not a longitudinal study.      Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic     filariasis and onchocerciasis, and investigators will compare the impact of these MDA     schedules on soil transmitted helminth infections. MDA will be administered by others     (Ivorian Ministry of Health).      The investigators will test the hypothesis that semiannual mass drug administration (MDA) is     superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for     control of soil transmitted helminth (STH) infections.        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug          administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.        2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug          administration (MDA) for elimination of onchocerciasis in these populations.        3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)          infection in these populations.   "
95812|NCT02032030|"     Based on limited published epidemiological data, up to an alarming 1 in 50 surgical     inpatients die within 30 postoperative days. Based on our own data from the B-Unaware     (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality     among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and 1-year     mortality among high-risk surgical patients may be as high as 10%. Short- and     intermediate-term postoperative mortality is therefore a pressing public health concern.     Similarly, postoperative major morbidity - including delirium, stroke, myocardial infarction,     atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia, respiratory     failure, loss of functionality, and chronic pain - occurs commonly and affects a substantial     proportion of surgical patients, critically ill patients and patients undergoing procedures     for chronic pain. Many factors associate strongly and independently with postoperative     mortality and major morbidity: patient age, functional status, comorbid medical conditions,     and duration and invasiveness of surgery, among others. It is a strategic priority to     identify pre- and intraoperative risk factors that are subject to modification.   "
95813|NCT02032017|"     The purpose of this study is to investigate whether revalidation following total hip     replacement through the percutaneous approach is faster or better than following the     anterolateral approach. We assume this would be the case since it is possible to spare a     large part of the gluteus medius muscle with the percutaneous approach.   "
95816|NCT02031978|"     The goal of the study is to be a current examination of infant and toddler feeding practices     among families receiving WIC services. It has been more than 10 years since the last study of     such feeding practices, and in the interim important changes have taken place in the WIC     program, in society, and in the science of nutrition. The study will include exploration of     breastfeeding practices and support, more general feeding practices, nutritional intake of     infants and toddlers, transitions in infant and toddler feeding practices, early precursors     of obesity, and family factors that may influence all of these nutrition-related issues. It     will also explore characteristics of the WIC program in selected sites, and how these relate     to infant and toddler feeding decisions and practices. This study is important both to update     knowledge about the WIC population, and to uncover possible new avenues of inquiry regarding     early childhood obesity.   "
95817|NCT02031965|"     This phase I trial studies the side effects and the safety of injecting HSV1716 (a new     experimental therapy) into or near the tumor resection cavity. The injection will be done at     the time of surgery. HSV1716 is a virus that has a gene which has been changed or removed     (mutated) in such a way that lets the virus multiply in dividing cells of the tumor and kills     the tumor cells.   "
95818|NCT02031952|"     The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC)     patients in clinical practice. While many patients suffered the recurrence without the     evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the     value of preventive resection of regional lymph node for those patients. Recently, more and     more studies had found the incidence of lymph node metastasis was higher in autopsy specimen     than those in operable patients.      This project is a prospective randomized controlled trial, planning to compare hepatectomy     with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC     patients, to reach a further understanding of the role of lymphadenectomy.   "
95819|NCT02031939|"     Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence     in locally advanced rectal cancer, systemic failure remains a predominant issue probably due     to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment.     Induction chemotherapy is one of the most studied strategies. However, the efficacy of     induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our     previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant     chemoradiotherapy can improve response rate of rectal cancer patients, but the results have     not been confirmed in clinical trial. Whether this new kind of treatment can optimize     neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in     clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.   "
95820|NCT02031926|"     Healthy subjects will be trained to used correctly a positive expiratory pressure device. The     aim of the study is to evaluate te reproductibility of the correct used of the device after     training   "
95821|NCT02031913|"     Hepatic steatosis and insulin resistance are associated with severity of fibrosis in     non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical     significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is     not well established. The aim was to investigate the relationship between insulin resistance,     hepatic steatosis, and fibrosis in patients with CHB.   "
95822|NCT02031900|"     This is a single center, single arm, open label observational trial of patients undergoing     EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to     position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to     identify and discriminate abnormal areas of tissue from normal.   "
95824|NCT02031874|"     Immunosuppressed patients are at increased risk for complications of influenza infection,     including secondary pneumonia and are recommended for annual influenza vaccination. Thus, the     appearance of a novel subtype of influenza A virus designated as 2009 swine H1N1 virus has     added an extra layer of complexity in the immunization regimen in this population. In     general, susceptibility to swine H1N1 infection among young population is higher as young     adults and children completely lack protective titers. According to the Center for Disease     Control (CDC), 70 percent of people hospitalized with H1N1 have been high risk cases,     including persons 65 years of age or older, or people with compromised immune systems as     observed during HIV infection. This has prompted CDC to include HIV infected children to be     one of the five groups to be vaccinated with the new H1N1 vaccine (National Center for     Immunization). Currently no information exists about the nature of the immune response to the     vaccine against H1N1 swine-origin influenza virus (S-OIV) in HIV infected children. It is     unknown whether HIV impairs the immunogenicity of the vaccine predisposing this population to     infection with S-OIV. Thus, a pilot proposal is being undertaken to study the mechanism of     H1N1 vaccine protection in HIV infected children, by investigating the correlation of     infection status with seroresponse, duration of response and development of influenza-like     illness following vaccine. Additionally we will establish whether we can identify immune     signatures by characteristic gene expression patterns correlating with the vaccine     immunogenicity that can be predictive of efficacy for good and suboptimal vaccination     regimen. Data generated will be used to initiate a comprehensive study on the immunogenicity     of the influenza vaccines in HIV-infected children and youth, which is critically important     to address the health care needs of this vulnerable population.   "
95825|NCT02031861|"     The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran)     with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate     essential hypertension.   "
95826|NCT02031848|"     By doing this study, researchers hope to learn whether a person's motivation for food is     different after he or she loses weight, and if imaging techniques such as fMRI can be used to     predict whether the person will maintain that weight loss over time.   "
95851|NCT02031523|"     It is a multi-center, double -blind, placebo -controlled, randomized post-marketing study in     Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in     the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.   "
95852|NCT02031510|"     The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block     will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.   "
95853|NCT02031497|"     The purpose of this study is to determine whether consumption of carbonated drinks containing     sweeteners affect insulin sensitivity.   "
95854|NCT02031484|"     This study is intended to compare the new Carnation patch monitoring system with the Zio     patch, which represents the current standard for continuous recording of the ECG over     extended periods.   "
95827|NCT02031835|"     The purpose of this current prospective study is to assess the effects of body weight support     treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training     intervention aim at improving: quality of life, walking capability, spasticity, functions in     every day life, bone mass density and related hematological factors. The examination     consisted of (1) neurological classification by ASIA standard neurological classification of     spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified     Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury     II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life-     BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone     mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue     consistency by full body DXA scan, (8) skeletal system health associated blood factors     (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid     hormone) by hematological tests. The results will be collected and evaluated using     statistical software (i.e. SPSS).   "
95828|NCT02031822|"     Headache is one of the most common reasons for patients to access healthcare. Greater     occipital nerve (GON) block with local anesthetic and steroid has been described for the     management of primary headache refractory to conventional treatment. Two ultrasound     (US)-guided techniques for greater occipital nerve (GON) block have been described for the     management of refractory headache syndromes: a proximal technique performed at the level of     the second cervical vertebra and a distal technique performed at the level of the superior     nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two techniques     in patients with refractory headaches.   "
95829|NCT02031809|"     This study investigates the most common major complications that result in unplanned     additional surgery in patients undergoing vats anatomical resections. Several high-volume     European centres participate. The purpose is to quantify these major complications, discuss     the steps that can be taken to prevent these events, how they can be dealt with, be it by     vats or conversion   "
95830|NCT02031796|"     The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular     Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for     use during transcatheter aortic valve implant (TAVI) procedures. CAVAREC utilizes the same     x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to     allow CAVAREC will occur during the TAVI procedure and after the TAVI device is implanted. If     you already have a surgically-implanted TAVI device and are having a cardiac catheterization,     then an extra set of images will be acquired after your clinical care is complete, but before     you leave the procedure room. The CAVAREC image processing algorithm will be implemented on     an off-line workstation after the TAVI procedure is complete. After the TAVI procedure,     CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT and     cardiac CT images from Radiology. The results of this study will be used to direct further     development of CAVAREC toward the end goal of providing improved imaging capabilities to     guide TAVI procedures.   "
95831|NCT02031783|"     The primary objective is to show that multiple transportable carbohydrate ingestion is more     effective in improving endurance performance compared to single transportable carbohydrate     ingestion.   "
95832|NCT02031770|"     Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney     disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic     acidosis is a common complication of CKD resulting from an inability of the diseased kidney     to excrete the daily dietary acid load and it is associated with all-cause mortality in     patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium     bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not     been evaluated. The investigators propose a prospective, randomized, controlled, open-label     14-week crossover pilot study examining the effect of treatment of metabolic acidosis with     oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV     with metabolic acidosis.   "
95833|NCT02031757|"     Gait dysfunction often occurs following stroke, neurological or musculoskeletal disease,     injury and surgery. One of the consequences of such deficit is an increased risk of fall and     injury. A gait training regime that incorporates controlled perturbation has been found to     reduce falls in elderly population but the effectiveness of such training has yet to be     studied.      The aim of this study is to evaluate the effectiveness of specific controlled dynamic     perturbation training, during gait, on gait rehabilitation, fear of falling and falling with     gait impaired individuals. Perturbation will be performed using a specifically designed     system that provides small, controlled and unpredictable perturbations during treadmill     walking.   "
95834|NCT02031744|"     This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety     and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with     treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung     cancer (NSCLC). Patients will be randomized in a 2:1 ratio to receive either MetMAb + Tarceva     or placebo + Tarceva. Tarceva (150 mg) will be given orally once daily, and MetMAb (15 mg/kg)     will be given intravenously every 3 weeks. Treatment will continue until disease progression,     unacceptable toxicity, a decision to discontinue, or death occurs. Total study length is     expected to be around 36 months.   "
95835|NCT02031731|"     This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in     chinese patients with locally advanced or metastatic solid tumors. Patients will be divided     into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be     treated sequentially, starting with the lowest dose. MetMAb will be administered     intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1     year, whichever occurs first, in the absence of disease progression.   "
95836|NCT02031718|"     This study will develop and evaluate the efficacy of an Internet-based education program     incorporating virtual coaching. For this study, the virtual coach will consist of online     videos aimed at providing acne education and promoting behaviors that support healthy skin.     The use of Web-based technologies and virtual coaching in acne-related patient education is     novel, and may significantly improve clinical outcomes and quality of life in acne patients.     We hypothesize that an interactive Internet-based education and counseling program will be     more effective than Internet-based education alone in improving clinical outcomes and quality     of life in acne patients.   "
95839|NCT02031679|"     The investigators are recruiting for a chronic hives study. This research is being done to     test whether an investigational drug called AstraZeneca drug (AZD)1981 may be helpful for     treating people with Chronic Idiopathic Urticaria who continue to have symptoms despite     taking antihistamines. The word investigational means that AZD1981 is not approved for     marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of AZD1981     in this study.      People with chronic hives lasting for at least 6 months and without a known cause may join.     The study involves 6 visits over 8 weeks. Approximately 48 participants expected to take part     in this study at the Johns Hopkins Asthma and Allergy Clinic. All participants will be     treated with the study medication and/or placebo for 8 weeks.      The results of this trial may have a benefit others with Chronic Idiopathic Urticaria who     don't respond well to antihistamines by generating experience and data to support the design     of a larger, multicenter trial investigating the efficacy of AZD1981 in treating     antihistamine refractory CIU.   "
95840|NCT02031666|"     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the     medication) and relative bioavailability (the extent to which a medication or other substance     becomes available to the body) of JNJ-56021927 when administered as 7 test tablet     formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927 in     healthy male participants under fasted conditions at a single dose of 240 mg.   "
95841|NCT02031653|"     To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction     (BOO) in men with benign prostatic hyperplasia.        1. Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level          of accuracy without the morbidity and expense of invasive Pressure flow study.        2. Penile cuff test may be particularly useful in the counseling of patients prior to          benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a          penile cuff test can be reassured that surgery has a high chance of resulting in          symptomatic benefit   "
95842|NCT02031640|"     This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group,     12-week study in male and female patients, 12 years of age and older, with persistent asthma.   "
95843|NCT02031627|"     Proof of principle study in order to determine if there is a difference in treatment effect     across the 3 study groups when treating lower extremity lymphoedema using a pneumatic     compression device.   "
95844|NCT02031614|"     Although phlebotomy is routinely performed in blood donors, and seemingly does not have     significant health risks, it is highly relevant to know what the effect of phlebotomy is on     immunity. Alterations in immunity due to phlebotomy could have beneficial effects, like the     suppression of the low grade inflammatory process that contributes to atherosclerosis, but in     theory could also contribute to a suppressed innate immune response that could increase the     risk of infection. This is not only relevant for blood donors, but also for patients     suffering from blood loss and for daily clinical practice in which blood is routinely drawn     of patients for laboratory determinations.   "
95845|NCT02031601|"     Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine     kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment     for patients with non-small-cell lung cancer (NSCLC).      Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be     randomly assigned to combination therapy group (receiving four cycles of docetaxel or     pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or     Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib,     daily). All patients were continued to receive TKI until progression or unacceptable to     toxicity or death. The primary endpoint was progression-free survivial (PFS).      Expected results: PFS of combination therapy group will be prolonged to nineteen months while     PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy     group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months.      Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as     first-line treatment will prolong PFS and OS for patients with NSCLC.   "
95847|NCT02031575|"     The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate     the effectiveness of using text messages to improve the knowledge, communication, and     attitudes about reproductive health among female adolescents in Greater Accra senior high     schools. Previous research as well as qualitative work conducted by the Investigators shows     that there are significant gaps in knowledge about reproductive health including on topics of     pregnancy, sexually transmitted diseases, and contraception among secondary school students     in Greater Accra. These gaps contribute to unwanted pregnancy and spread of sexually     transmitted diseases. At the same time, phone ownership and use among young people has spread     rapidly, especially in urban areas such as Accra. The Study on Mhealth and Reproductive     Health (SMART) will seek to use mobile phone messages to increase awareness of these     reproductive health issues among female adolescents in Accra. The objectives of SMART are to     evaluate whether the messages can increase knowledge, increase communication, and improve     attitudes towards reproductive health among adolescents in Greater Accra. By conducting a     randomized controlled trial, we will be able to statistically evaluate if the messages have     had any effect on improving outcomes for adolescents in the areas of knowledge,     communication, and attitudes. This work can help guide future programs that can scale up this     intervention and ultimately improve the health and wellbeing of adolescents across Ghana.   "
95848|NCT02031562|"     This study evaluates the effect of standard of care treatments (physical therapy versus     manual therapy) in older adult patients who have balance problems with or without low back     pain.   "
95849|NCT02031549|"     We will investigate potential correlation between SpermComet DNA fragmentation assay results     and IVF cycle outcome.   "
95850|NCT02031536|"     This randomized phase II trial studies how well everolimus works in treating patients with     pancreatic neuroendocrine tumors metastatic to the liver previously treated with surgery.     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Giving everolimus after surgery may kill any tumors cells that remain.   "
95855|NCT02031471|"     This open-label, single-arm study will evaluate the efficacy, safety and tolerability of     subcutaneously administered tocilizumab in monotherapy and/or in combination with     methotrexate and other non-biologic disease modifying anti-rheumatic drug (DMARDs) in     participants with active rheumatoid arthritis (RA) who are naïve to tocilizumab. Participants     will receive tocilizumab 162 milligram (mg) subcutaneously weekly for 24 weeks. Participants     who complete the core study achieving at least a moderate European League Against Rheumatism     (EULAR) response at Week 24 may enter the extension phase and receive for a further 28 weeks     at the most.   "
95856|NCT02031458|"     This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in     participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer     (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3     weeks as long as participants are experiencing clinical benefit as assessed by the     investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration     attributed to disease progression.   "
95857|NCT02031445|"     Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and     safety study in subjects with mild to moderate atopic dermatitis.      Following the double blind period, subjects will be allowed to continue treatment with     topical MRX-6 Cream 2% in an open-label extension. Demonstrate the efficacy of MRX-6 Cream 2%     compared to Vehicle for the treatment of the signs and symptoms of atopic dermatitis and     demonstrate the safety of MRX-6 Cream 2% for the treatment of the signs and symptoms of     atopic dermatitis.   "
95858|NCT02031432|"     The purpose of this trial is to find out how well cebranopadol is tolerated and how often,     and which, adverse reactions occur when it is taken every day for a longer period of time. In     addition information will be collected how cebranopadol affects pain and well-being in     patients suffering from cancer-related pain.   "
95859|NCT02031419|"     First study, at multiple clinical centers, exploring the effects of different combinations of     compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma     (DLBCL)   "
95860|NCT02031406|"     A significant portion of avoidable healthcare expenditures has been attributed to preventable     hospital readmissions; thus, reducing hospital readmission rates has become a national     healthcare agenda item. Despite much study of this topic, efforts to date have not been     especially fruitful in either predicting which patients will require hospital readmission.     Preventing readmissions has been even more difficult.      We recently examined a pharmacist intervention that assessed patients' medication literacy     and adherence at hospital admission. In this retrospective data, low medication adherence     levels were predictive of hospital readmission. There was a non-significant trend between low     medication literacy and increased hospital readmissions.      We have now decided to prospectively study this intervention. Prospective study will allow     for several improvements on our prior work.        1. We have consulted the literature to more carefully examine existing instruments to          measure medication adherence and literacy. Based on this review, and based on our prior          results, we have made adjustments to these instruments which should improve reliability,          validity, and granularity.        2. In our retrospective work, our intervention of pharmacist counseling was not randomized.          Although there were large differences in readmission rates between the patients selected          to receive counseling and those who were not thought to require it, there may have been          unmeasured confounding variables. Randomizing this intervention will greatly enhance the          likelihood that we are comparing two similar groups of patients.   "
95861|NCT02031393|"     The purpose of this study is to determine whether we can establish different markers suc as     mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood     and more un the first trimester, in order to screen for twin pregnancies that are more likely     to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.   "
95862|NCT02031380|"     The purpose of this study is to evaluate the usability of a medication management support     system for glaucoma patients self-administering eye drops named iDropper. The iDropper system     is a home-based ocular medication management system that reminds, instructs, dispenses, and     records eye drop medication usage. The iDropper system will be evaluated among a cohort of     glaucoma subjects self-administering eye drops for 4-weeks.   "
95865|NCT02031341|"     Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus.     It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle     interstitium plays a role in this process.      We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle     interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes     mellitus.   "
95886|NCT02031068|"     To test the safety and feasibility of a new treatment for adolescents who are slow to recover     from a sport-related concussion, the investigators are conducting a randomised controlled     trial comparing treatment as usual with an active rehabilitation program that involves     sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive     visualisation techniques.   "
95887|NCT02031055|"     The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass     balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or     [14C]TPI.   "
95888|NCT02031042|"     The purpose of this study is to investigate if sentinel lymph node biopsy is a reliable     staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast     surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the     sentinel lymph node is free of metastasis.   "
97066|NCT02015676|"     This study will define an optimal chemotherapy dose regimen of Myocet in combination with     paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose     regimen in patients with metastatic or locally advanced breast cancer and HER2     overexpression. The anticipated time on study treatment is 3-12 months.   "
95866|NCT02031328|"     You have been asked to consider participating in the study because you have a cancer of the     prostate, which is to be treated with external beam radiation. You have chosen or felt not to     be a good candidate for just watching your cancer. As your doctor has informed you, this     involves delivering small amounts of radiation daily over several weeks. Normally, a small     field directed to the prostate gland is given for 7.5 - 8 weeks. In total, 39 days of     radiation are delivered. There is now growing evidence that prostate cancer cells may be     killed more effectively if higher doses of radiation are delivered everyday (known as     hypofractionation). However, the downside to such a strategy is the potential to cause more     side effects because normal organs (such as the rectum and bladder) are also exposed to the     higher doses. Stereotactic ablative radiotherapy (SABR) is a high-precision technique which     has the ability to deliver radiation in a more focused manor, meaning that the radiation dose     can be sculpted to the prostate gland, while minimizing the amount of radiation to the     bladder and rectum.      A certain amount of movement of the prostate normally occurs within the body. To make sure     that the prostate will not be missed, a margin of tissue around the prostate also needs to be     treated. Although a wide margin will ensure that the prostate is included, it will also cause     more normal tissue to receive high doses of radiation. This, in turn, would result in more     side effects. To reduce the margin needed around the prostate, and side effects, tiny gold     seeds measuring 3.0 x 1.2mm will be inserted into the prostate which can be seen using a     special type of X-Ray camera called a portal imager during treatment. This will allow for     targeting of the prostate gland more precisely so that a significantly smaller margin of     normal tissue will need to be treated. By using gold seeds in conjunction with SABR, there is     the potential to safely deliver a more intensive dose of radiation to the prostate gland     without increasing the amount of side effects.      In other studies where shorter and more intense courses of radiation have been given using     similar high-precision techniques, the side effects of treatment have indeed been no worse     than the usual techniques. Over the last 7 years, Sunnybrook researchers have treated over     three hundred prostate cancer patients on various research protocols with SABR. In those     protocols, patients received 5 SBRT treatments over 29 days and this is currently being     compared to 5 SBRT treatments over 11 days in an ongoing randomized study. In the United     States, several groups have investigated the 5 SBRT approach in 11 days or less and early     findings suggest a good tolerance.      The study is being done to determine the side effects, quality of life and efficacy of     2-fraction adaptive SBRT technique (2STAR) in the treatment of low and intermediate risk     prostate cancer. All participants will receive the same dose and fractionation scheme.   "
95867|NCT02031315|"     Background The burden of sudden death (SD) in sub-Saharan Africa is unknown. The aim is to     assess the incidence, etiology and patient characteristics of SD in a sub-Saharan country.     Methods The Douala-SD study is a prospective, multicenter, community-based registry     monitoring all cases of SD occurring in index areas of Douala city. Investigators will use     the definition of SD as natural death occurring within 24h at the onset of symptoms.     Demographic, clinical, electrocardiographic and biological variables (when available) of     victims will be recorded. All deaths occurring in residents of health areas of interest will     be checked for past medical history, circumstances of death, and autopsy (if possible).     Conclusion This maiden Douala-SD study will provide comprehensive, contemporary data on the     epidemiology of SD in a sub-Saharan African country and will help in the development of     strategies to prevent and manage SD in Africa.   "
95868|NCT02031302|"     The purpose of the RESPOND post market study is to collect real world clinical and device     performance outcomes data with the Lotus Valve System used in routine clinical practice to     demonstrate that the commercially available Lotus Valve System is a safe and effective     treatment for patients with severe calcific aortic stenosis.   "
95869|NCT02031289|"     We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac     surgery. The study will answer the question of whether preoperative treatment of anemia or     iron deficiency indeed improves transfusion needs (primary outcome) and important clinical     outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of     inclusion and exclusion criteria was deliberately chosen short so that this patient group     largely reflects today's clinical practice .        -  Trial with medical product   "
95870|NCT02031276|"     This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled,     parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19     antagonist monoclonal antibody, in patients with moderately to severely active Crohn's     disease.   "
95871|NCT02031263|"     The investigators will find out if bronchial thermoplasty shows efficacy in reducing acute     exacerbation and improving quality of life for uncontrolled asthma in Korea through this     research. US FDA approved this procedure and CE mark was taken in Europe. Many procedure was     performed in Western countries.      Korean FDA have approved this procedure in 2013. However, no procedure was performed in     Korea, and the data is rare in Asian countries. In this study, investigators will examine the     efficacy of this procedure in Korean asthmatics.   "
95872|NCT02031250|"     This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC)     patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be     resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced     Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and     surrounding normal tissues will be maintained.   "
95873|NCT02031237|"     This study aims to assess changes in vascular permeability in the brain tumor, and in the     surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).   "
96063|NCT02028767|"     The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed     dose combination tablets compared to tablets administered together in healthy male and female     volunteers under fed conditions.   "
95876|NCT02031198|"     This follow-up study continues to observe patients who have completed the phase 1 trial of     AADvac1, for another 18 months.      Long-term safety and behavior of the immune response to AADvac1 over time are the main points     of interest.      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is     the main constituent of neurofibrillary tangles (NFTs), and is intended to be a     disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.      As this study is a Phase I study focused on tolerability and safety, efficacy will be     assessed in an exploratory manner.   "
95897|NCT02030925|"     This study is meant to assess the effect of IW-3718 as an added treatment to ongoing     once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience     symptoms of their gastroesophageal reflux disease (GERD).   "
95944|NCT02030314|"     Chlorthalidone might offer an effective, safe and inexpensive anti-hypertensive treatment for     kidney transplant patients who have resistant hypertension on multi-drug therapy. We will     collect initial data on the safety and efficacy of Chlorthalidone in the treatment of     patients with resistant hypertension.      To Examine the efficacy of chlorthalidone as an anti-hypertensive agent in the treatment of     resistant hypertension among stable kidney transplant recipients   "
95877|NCT02031185|"     Due to disparities in childhood obesity, interventions for physical activity promotion and     obesity prevention for low socioeconomic and racial/ethnic minority children and adolescents     are vital to address disparities across the lifespan. Mobile health applications (mHealth     apps) are a rapidly growing and promising approach for interactive and individualized     interventions for disease prevention. Smart phones are a promising platform to reach     racial/ethnic minority and lower income groups due to high rates of adoption of smart phone     usage among these groups When paired with wearable sensing devices, mHealth apps for smart     phones can collect data and provide feedback to users in real time. In a study among     university students regarding mHealth apps, participants expressed interest in the ability     to record and track behaviors and goals and the ability to acquire advice and information 'on     the go'. For physical activity in particular, wearable physical activity monitors designed     for consumers that objectively measure and display data related to an individual's physical     activity on smart phones through mHealth apps have become widely available and affordable.     These wearable devices wirelessly upload data and provide users with physical activity data     visualization and goal setting features that can be customized for each user via     internet-based applications for smart phones, tablets, and/or computers. While several     internet-based behavioral programs to promote pediatric physical activity have been reported     in a recent review, none examined wearable sensing devices coupled with mHealth apps.     Similarly, a 2013 review on mHealth technologies for physical activity assessment and     promotion reported no studies that used wearable sensing devices for intervention delivery     and called for research to evaluate feasibility.      The Primary Goal is to conduct a pilot randomized controlled trial (RCT) of the FitBit Flex,     a popular wearable physical activity sensing device that allows data visualization and goal     setting on smart phones. The target population will be adolescents ages 14-18 years old in     the Seattle-metro area (n=40) with approximately 50% from low income households or belonging     to a racial/ethnic minority. We will target this older age group since they have the lowest     levels of physical activity among the pediatric population. This pilot study will provide     feasibility and preliminary data for a future R01-funded RCT of the Flex mHealth device and     app.   "
95878|NCT02031172|"     This research is being done to to see if changes in visual reading function correlate with     changes in optical and retinal image quality. We hypothesize that changes and deterioration     in tear film quality and dynamics may have a negative effect on reading function.      People with or without dry eye syndrome may enroll.   "
95879|NCT02031159|"     Hypothermia is common in patients undergoing general anesthesia. There have been several     negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body     core temperature. The aim of this study is to see if this method is comparable in terms of     correlation, accuracy, precision and practicability to commonly used sublingual and     nasopharyngeal temperature monitoring.   "
95880|NCT02031146|"     Treponema pallidum, the bacterium that causes syphilis, invades the central nervous system in     about 40% of patients with syphilis. This happens early after infection. Patients with     neuroinvasion are at risk of developing serious neurological complications, including vision     or hearing loss, stroke and dementia. Because neuroinvasion can happen without symptoms, the     only way to identify it is by performing a lumbar puncture (LP) to examine cerebrospinal     fluid (CSF).The overall hypothesis to be tested in this study is that a strategy of immediate     LP, followed by therapy based on CSF evaluation, results in better serological and functional     outcomes in patients with syphilis who are at high risk for neuroinvasion.   "
95881|NCT02031133|"     Study SPC3649-207E is designed as an extension study to the prior protocol to provide     additional long-term safety and efficacy information for subjects participating in Study     SPC3649-207.   "
95882|NCT02031120|"     The aim of this study is (1) to assess the incidence of suspected drug allergies in a     pediatric hospital and the proportion in which these reactions are confirmed to be allergic;     (2) to evaluate the diagnostic values of the different allergy tests available; (3) to     investigate the pathophysiology of drug allergies, particularly by investigating the role of     viruses, and by performing HLA typing and a gene expression profile both in the acute phase     of the reaction and 2 months later.   "
95883|NCT02031107|"     Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation can     induce significant and sustained improvements in functional outcome. However the effect is     inconsistent and difficult to predict, in particular in the subacute phase after stroke.     Although several different stimulation techniques are available, it is unknown which is     suitable for which patient.      Objectives: This study has three main objectives:        1. To compare the effects of two techniques of non-invasive brain stimulation (cTBC,          continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on          clinical recovery in patients with subacute stroke.        2. To assess the effect of these brain stimulation techniques on brain organization with          non-invasive imaging.        3. To find clinical and neural predictors of responsiveness to brain stimulation therapy.      Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3     groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding     stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical     therapy. Before and after the treatment period, standardized assessments of sensorimotor     function areas are obtained together with electroencephalography and functional magnetic     resonance recordings. These recordings will be used to analyze and compare the neural effects     of each treatment modality.      Clinical Implication: The results of this study might help optimize and individualize     stimulation treatment for patients with subacute stroke. It may hence facilitate the transfer     of brain stimulation therapy to routine clinical practice.   "
95884|NCT02031094|"     This observational study will measure resting energy expenditure in patients who have     undergone liver resection and compare methods of measuring resting energy expenditure.   "
96064|NCT02028754|"     This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the     treatment of dry eye after cataract surgery.   "
95885|NCT02031081|"     The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort     include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis     slows digestion, it can lead to malnutrition and make controlling blood sugar even more     challenging for diabetics. Mild cases of gastroparesis can be helped with dietary and     lifestyle modifications but treatments for more severe symptoms are limited. There are     several drugs called pro-kinetics available in Canada though results vary among patients and     these often cause significant side effects. Recently, a drug called Prucalopride was approved     for use in Canada to treat constipation. It has pro-kinetic properties and has been shown to     cause few side effects. The investigators propose to test prucalopride as a treatment for     gastroparesis by recruiting 30 patients from the Calgary area who have gastroparesis. The     investigators will test the effects of this treatment by alternating 28 days of active     treatment with prucalopride with 28 days of treatment with a non active placebo adding a two     week break in between treatments. The order of the treatment will be randomized and neither     the patients nor the investigators will know whether they are receiving the active treatment     or the placebo until the study has been completely finished. The investigators will measure     the effects using questionnaires that assess patient symptoms such as nausea and pain as well     as quality of life during two gastric emptying tests and throughout the treatment periods.     The effectiveness of the active treatment will be evaluated by comparing the extent of the     change in symptoms before and after treatments and the difference in gastric emptying times     as compared to the placebo treatment. The investigators will also monitor and track all     possible side effects that patients experience during the study.      Study Hypotheses      In patients with gastroparesis:        1. Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined by          the change in cumulative meal-related symptoms. (primary endpoint).        2. Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo.          (secondary endpoint).        3. A correlation exists between the effect of prucalopride on gastric emptying rate and          symptom improvement.   "
95945|NCT02030301|"     The purpose of this study is to test the safety and effectiveness of two experimental     therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).   "
95889|NCT02031029|"     It has previously been reported that men with prostate cancer are 1 ) reduced quality of life     after diagnosis and treatment, 2 ) neuroticism increases the reduction in QoL related to     treatment side effects, and 3) often have very involved and active spouses who seems to have     been handed over / taken over parts of the men's responsibility for their own health. We     postulate herein a new hypothesis that the stress level is elevated when harbouring     undetected prostate cancer. We will investigate whether those who are diagnosed with prostate     cancer already in beforehand have an increased degree of masculine stress ( experience of not     living up to their own perception of the ideal man ) and neuroticism in the typology. We will     examine different personality and QoL questionnaires for patients with elevated PSA, and     compare those whose clinical assessment later reveals prostate cancer, with three control     groups: 1) men with elevated PSA who are not diagnosed with prostate cancer, 2) men with     normal PSA treated for benign prostate enlargement and 3) patient with substantial risk of     colorectal cancer (CRC) who undergo colonoscopy, with regard to increased level of masculine     stress and the personality trait neuroticism.   "
95890|NCT02031016|"     This study will investigate the influence of intra-operative use of remifentanil versus     fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via     sternotomy. Secondary quantitative sensory testing is performed to determine thermal and     electrical detection and pain threshold and the difference in pain variability scoring.     Postoperative pain scores, analgesic use, genetic variances and costs are measured.   "
95891|NCT02031003|"     -  The primary objective of the study was to compare stool composition (stool soap and          non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of          infants randomized to receive either standard formula, or 1 of 2 innovative formulas          containing a new fat blend or the new fat blend plus fiber.        -  The secondary objectives were to evaluate among the feeding groups, stool          characteristics (stool consistency and frequency), GI tolerance assessed by the Infant          Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and          8-hydroxy-2'-deoxyguanosine [8-OHdG], and urine osmolality and specific gravity).        -  The primary safety objective was to describe the frequency of adverse events (AEs) among          the formula-fed (FF) groups.        -  The secondary safety objective was to describe anthropometric measures (weight, length,          and head circumference) among the feeding groups.   "
95892|NCT02030990|"     1. Purpose To evaluate the use of mitomycin-C (MMC) as an intraoperative adjunct during          photorefractive keratectomy (PRK), its effect on postoperative healing and its ability          to reduce the postoperative topical steroid course after the surgery.        2. Research Design This is a single-center, prospective, comparative cohort study.        3. Hypothesis There will not be a significant difference in the refractive corrections          amongst the treatment groups, 12 months after surgery.        4. Objectives The primary study objective is to compare the effect of intraoperative MMC          and a postoperative short topical steroid taper of 3 weeks, intraoperative MMC and a          rapid topical steroid taper of 1 week, and a more commonly accepted postoperative          regimen of a 2 month long topical steroid taper without any intraoperative MMC. The          primary endpoint evaluated will be objective estimates of refractive error (WaveScan          WaveFront™ System) at 12 months post-surgery. Secondarily, the extent of haze formation          will be evaluated objectively using densitometry maps generated by automated Scheimpflug          imaging of the cornea (Pentacam®). Furthermore, the subjective vision from the patients'          perspective will be evaluated by questionnaires.   "
95893|NCT02030977|"     To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory     factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients     who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly     allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be     advised to adherence our diet and exercise program too. At the first and the end of the     intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis     will be assessed and compared between groups.   "
95894|NCT02030964|"     This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV     chemotherapy medicines called cyclophosphamide and topotecan.        -  To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and          topotecan without causing severe side effects.        -  To find out the side effects seen by giving DFMO at different dose levels with          celecoxib, cyclophosphamide and topotecan.        -  To measure the levels of DFMO in the blood at different dose levels.        -  To determine if your tumor gets smaller after treatment with DFMO, celecoxib,          cyclophosphamide and topotecan.        -  To determine if specific gene changes in you or your tumor makes you more prone to side          effects or affects your tumor's response to the combination of DFMO, celecoxib,          cyclophosphamide and topotecan.        -  To determine if the amount of normal chemicals in your body called polyamines go down in          response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more          likely to have a good response to the treatment if they do.   "
95895|NCT02030951|"     Feeding that circumvents the oral cavity drastically alters the infant's feeding experience     (pre, intra and post feeding) and may lead to oral feeding difficulty. It is estimated that     35 - 40% of infants exhibit oral feeding difficulty. Consequences include delayed oral     feeding, growth failure, and inadequate mother-infant interaction. Behaviors related to the     feeding experience include behavioral state transitions, orally directed behaviors, hunger     and satiation cues, and social interactive behaviors. It is unknown whether these early     behaviors differ for hospitalized infants who receive long term tube feedings when compared     with infants fed orally or whether alterations in these behaviors can be early indicators of     later oral feeding difficulty. Documentation of these missing or altered behaviors is needed     prior to the development and testing of interventions to prevent oral feeding difficulty.      For 75 hospitalized infants with long term tube feedings, this research will: 1) describe the     range of early feeding behaviors encompassing the feeding experience; 2) identify the change     in early feeding behaviors throughout hospitalization; 3) compare the early feeding behaviors     of infants with and without oral feeding difficulty at 12 months corrected age (CA); and 4)     compare parent perception and provider assessment of feeding, for infants with and without     oral feeding difficulty.      We will document infant behaviors surrounding the feeding experience during tube feedings     weekly during hospital stay. Throughout the first year of life, infant growth, parent     perception and clinician assessment of infant feeding and infant and maternal behavior during     feeding will be evaluated to document the occurrence of oral feeding difficulty, allowing for     a comparison with early in hospital feeding behaviors. To analyze for changes over time, we     will use Generalized Linear Mixed Models (GLMM) for repeated count (Poisson) and     frequency/categorical (logistic and multinomial logistic) outcomes (e.g., frequency of infant     behaviors). Understanding the constellation of these behaviors and when they begin, will     guide the development of interventions whose goal will be to alleviate the long term     consequences of oral feeding difficulty, inform clinical practice, and reduce cost.   "
95896|NCT02030938|"     An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support     in subjects undergoing revision augmentation surgery for increased nipple to inframammary     fold distance.   "
95898|NCT02030912|"     A randomised, open labelled study design is selected in order to determine the emergence and     persistence of antibiotic resistant bacteria in humans and on the composition of the     indigenous microbiotas at various body sites. These will involve the administration to     volunteers of minocycline and amoxicillin- a control group will receive a placebo.     Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse     events, vital signs, will be evaluated. The objectives of metagenomic analysis are:        -  To identify the in vivo molecular mechanisms responsible for antibiotic resistance and          its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome          analysis.        -  To determine the impact of the use of antimicrobial agents on the oral resistome        -  To determine the impact of the use of antimicrobial agents on the faecal resistome        -  To determine the ecological impact of the use of antimicrobial agents on the relative          abundance of phylotypes of the indigenous oral microbiota        -  To determine the ecological impact of the use of antimicrobial agents on the relative          abundance of phylotypes of the indigenous faecal microbiotas   "
95899|NCT02030899|"     The use of plate in addition to autologous bone is better then stand alone cage fusion     regarding fusion rate and segmental lordosis.   "
95900|NCT02030886|"     The purpose of the study is to assess the relationship between IOP pattern as recorded over     24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and     conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal     range is called ocular hypertension (OHT). In a previous study, it has been shown that OHT     patients who progress to glaucoma (converters) have at baseline and prior to any conversion,     IOP patterns that more closely resemble those of established early primary open-angle     glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer     to those of healthy control subjects. The study has been planned to recruit at least 48     eligible patients (24 converters and 24 non-converters).   "
95901|NCT02030873|"     The purpose of this study is to investigate the effect of virtual simulation training on     mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance     assessment using a final-product analysis approach and to explore the role of cognitive load.   "
95902|NCT02030860|"     This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to     target the microenvironment in resectable pancreatic cancer to determine the effect of     targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of     gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic     cancer through an assessment of cellular and imaging markers.   "
95903|NCT02030847|"     This is a single center, single arm, open-label phase II study to determine the efficacy and     safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors     expressing tandem TCR and 4-1BB (TCR/4-1BB) co-stimulatory domains (referred to as CART-19     cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.     Inclusion criteria are designed to include adult patients aged greater than 18 with B cell     ALL, relapsed or refractory, with no available curative treatment options (such as autologous     or allogeneic stem cell transplantation) who have limited prognosis (greater than 12 weeks     survival expectancy) with currently available therapies. The study product is CART-19 cells     transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a     single i.v. infusion of 1 to 5 x 108 transduced CAR T cells.   "
95904|NCT02030834|"     Phase IIa study to estimate the efficacy of a single infusion of autologous T cells     expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR /4-1BB)     costimulatory domains (referred to as CART-19 or CTL019 cells) in non-Hodgkins Lymphoma (NHL)     patients. The duration of active protocol intervention is approximately 24 months from     screening visit. The protocol will require approximately 48 months to complete.   "
95905|NCT02030821|"     The purpose of this study is to determine the relative effectiveness of two drug agents,     Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of     action. These agents are used to decrease blood loss that is a result of major surgery, like     total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total     hospitalization. Both TXA and Amicar are both currently used in the care of patients     undergoing total joint arthroplasty.      Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study     including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit     and hemoglobin, and complications will be collected during the hospitalization stay.      Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing     intraoperative blood loss and the need for transfusion post-op than Amicar.      A detailed cost analysis will show that the overall cost of performing the operative     procedure, including transfusions, OR time, and total costs associated with admission cost     will be more decreased with Amicar as compared to TXA.   "
96065|NCT02028741|"     The purpose of this study was to explore the immediate effects of transversrse vertebral     pressures (TVP) to the thoracic spine on cervical range of motion and pain in subjects with     neck pain,   "
95906|NCT02030808|"     Although the administration of muscle relaxation is essential standard of care for thoracic     procedures, it could cause long-reversal times and postoperative residual curarization (PORC)     increasing length of post-anesthesia care unit (PACU) stay and hospital costs. Sugammadex     offers new perspectives to reduce the incidence of PORC. Unfortunately it is not available in     many countries because of its significantly high cost. We hypothesized that the use of     target-controlled remifentanil infusion (TCI) with the non-muscle relaxant (NMR) would be     associated with comparable surgical conditions and reduced total costs compared with the use     of neuromuscular blockers during thoracotomy.      After ethical approval, 66 patients scheduled for elective thoracotomy under sevoflurane     anesthesia with TCI remifentanil will be included in this prospective, randomized,     single-blind, controlled study.      Patients will be randomly assigned to receive cisatracurium or saline (n = 33 for each group)     throughout the procedure. Laryngoscopy and intubating conditions, intraoperative modified     thoracic surgery rating scale (Table below), incidence of light anesthesia, and use of     vasopressors and anesthetics, clinical recovery, incidence of PORC, PACU and hospital stays,     and total costs will be recorded.   "
96119|NCT02028026|"     The purpose of this study is to determine whether vilazodone is more effective than     citalopram for the treatment of anxious depression. We will use neuroimaging to see whether     there are changes in the brains of patients receiving the drug vilazodone that are different     from those of citalopram. These changes may show that vilazodone affects the brain     differently than most other kinds of standard antidepressant medications.   "
95907|NCT02030795|"     The use of wire-guided Arndt® endobronchial blocker does not gain widespread acceptance     during video-assisted thoracoscopy (VATS) because it takes longer time to collapse the     operative lung especially in patients with chronic obstructive lung disease (COPD). The use     of a disconnection technique for deflation of Arndt® blocker had a comparable degree of lung     collapse with the use of double-lumen tubes. However, it carries a risk of blood or infected     secretions contaminating the dependent lung.      We hypothesise that the use bronchial suction of through a barrel part of a 1-mL insulin     syringe attached to the suction port of the bronchial blocker would be associated with     comparable time to optimum lung collapse with the disconnection technique.      After ethical approval, 58 patients with spontaneous pneumothorax scheduled for elective VATS     using Arndt blocker® for lung separation will be included in this prospective, randomized,     double-blind study.      Patients will be randomly assigned to deflate the blocker with either disconnecting the     endotracheal tube from the ventilator for 60 s. prior to inflation of the bronchial blocker     allowing both lungs to collapse, or attaching -20 cm H2O of suction to the suction port of     the blocker through the barrel part of a 1-mL insulin syringe (n = 29 for each group).   "
95908|NCT02030782|"     This randomized effectiveness trial evaluates a quality improvement intervention aimed at     providing access to evidence-based depression treatments (particularly cognitive-behavior     therapy for depression and or pharmacotherapy) through primary care for youth ages 13-21, as     compared to enhanced usual care. The major hypothesis is that the quality improvement     intervention will be associated with improved outcomes, relative to enhanced usual care.   "
95909|NCT02030769|"     Lugol's solution staining was regarded as a gold standard to detect early superficial lesion     during esophageal cancer screening using endoscopy. However, the sensitivity and specificity     were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was     previously shown to improve the visibility of gastrointestinal tract. It's unknown if the     pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A     randomized double-blind clinical trial was designed to investigate whether or not pronase     might improve detection rate of early esophageal lesion, especially high grade dysplasia and     early cancer by improving the esophageal visibility.   "
95910|NCT02030756|"     This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus     sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated     Individuals   "
95911|NCT02030743|"     The purpose of this study is to determine if training visual attention improves balance and     mobility, and reduces falls in older adults.   "
95912|NCT02030730|"     This study investigates the impact of a Triple P Seminar Series on positive parenting for     universal prevention of behavioural and emotional difficulties in a general Greek sample of     parents with children aged 2 to 12. It is predicted that, compared to an attention control     condition, parents randomised to the Seminar Series will report lower levels of children's     disruptive and emotional difficulties at post-intervention. At the same time, it is     postulated that parents will show a decrease in dysfunctional discipline styles, greater     feelings of self-efficacy as well as lower levels of distress. Lastly, it is hypothesized     that the effects observed at post-intervention will remain at the 6-month follow-up.   "
95913|NCT02030717|"     The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can     be better than epidural anesthesia during and after open surgery for renal cell carcinoma.     Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus,     shorten the hospital stay and rehabilitation of the patients.   "
95914|NCT02030704|"     To determine the ability of semi‐automated plaque assessment in cardiac computed tomography     angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of     patients at intermediate risk for coronary artery disease (CAD).   "
95915|NCT02030691|"     Respiratory distress is the main cause of morbimortality in preterm and term neonates. In     most of the case, these babies required the use of positive end expiratory pressure (PEEP)     delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is     widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation     (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.      We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with     respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these     devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy     (NIRS).   "
96080|NCT02028546|"     The purpose of this study is to determine the hydration effect of various regimens of skin     bathing and moisturizer application on atopic dermatitis   "
96081|NCT02028533|"     This is a pilot feasibility study assessing the tolerability of chronic administration of     intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are     actively using cocaine.   "
95916|NCT02030678|"     A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic     breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic     breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is     Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade     Adverse Events 、overall survival.All the patients will recieve this therapy till disease     progress or other occurrence of withdrawal standards.   "
95917|NCT02030665|"     Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana     dependence is not fully effective. In the current proposal we are exploring the idea that     more tailored teaching of coping skills may result in improved outcomes for     marijuana-dependence than those seen thus far. Participants will be 275 men and women meeting     criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of     4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or     IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two     weeks prior to treatment, for a weekly period during treatment, for another week after     treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions,     the information gathered from the pretreatment and during-treatment ES periods will provide     data for a functional analysis of patients' drug use and urges to use. It is hypothesized     that IATP conditions will yield significantly better coping skills acquisition than SMET-CB     conditions, both at posttreatment and at extended follow-ups, and that change in coping     skills will predict better outcomes for the IATP conditions   "
96155|NCT02027558|"     The purpose of this study is to determine whether a novel intervention combining cognitive     behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence     program provided by allied health personnel for older Veterans with obstructive sleep apnea     and comorbid insomnia improves nighttime sleep, PAP adherence, mood and health-related     quality of life.   "
95918|NCT02030652|"     The nasal CPAP (continuous positive airway pressure), is a technique of noninvasive     ventilation commonly used in neonatal intensive care units, and has recently been used in     association with nasal intermittent mandatory ventilation (NIPPV - intermittent Nasal     Positive Pressure Ventilation), which consists of the application of respiratory positive     pressure cycles during the application of nasal CPAP, resulting in high pharyngeal pressures.     The NIPPV has advantages over traditional CPAP, including the prevention of atelectasis,     improved respiratory mechanics and decreased work of breathing in premature infants. A     refinement of this technique is the use of positive pressure breaths associated with nasal     CPAP synchronously in relation to the newborn's inspiratory effort (SNIPPV - Synchronized     Nasal Positive Pressure Ventilation).      Synchronization allows that the cycles of inspiratory positive pressure provided by the     ventilator coincide with the inspiratory effort, increasing the system efficacy. The Neurally     Adjusted Ventilatory Assist (NAVA) is a mode of partial ventilatory support based on the use     of electrical activity of the diaphragm (Edi) to control the mechanical ventilator. The     ventilatory assistance starts according to respiratory needs of the patient, its use in very     low birth weight infants showed an improvement in patient-ventilator interaction, even in the     presence of leak around the endotracheal tube. This prospective randomized, clinical trial     aims to evaluate, in preterm infants with gestational age lower than 34 weeks with     respiratory failure treated with noninvasive ventilatory support, the impact of SNIPPV with     neural adjustment (NAVA) on success ventilation and the need for endotracheal intubation when     compared to treatment with traditional CPAP.   "
95919|NCT02030639|"     The purpose of this study is to gain an understanding of how the experimental anti-cancer     drug, rigosertib, is metabolized in the body and excreted in the urine and feces after it is     given as an intravenous infusion. In addition, the study will be carefully monitored to see     if any side effects occur.      A radioactive drug is used in this study because it is easier and more accurate to measure     radioactivity than to use more complicated and less sensitive chemical tests for the drug.   "
95920|NCT02030626|"     The present study aims to compare directly the efficacy of two noninvasive neurostimulation     techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical     current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.   "
95921|NCT02030613|"     The purpose of this study is to determine the optimal dosage of etanercept in patients     treated for idiopathic juvenile arthritis   "
95922|NCT02030600|"     This trial is conducted in the United States of America (USA). The aim of the trial is to     compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with     or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects     with type 2 diabetes.   "
95923|NCT02030587|"     This is a prospective randomized controlled study comparing laparoscopic adrenalectomy (LA)     versus image-guided percutaneous radiofrequency ablation (RFA) in treating     aldosterone-producing adenoma.      The objectives of this study are to        1. compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma.        2. compare the treatment success rates of LA and RFA during follow-up for primary          aldosteronism.   "
95924|NCT02030574|"     The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for     approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce     the size of the cancer in your bladder before surgery and can also help to reduce the chance     that your bladder cancer will come back (metastasize) in other parts of your body after     bladder surgery.      This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose     of this study is to test the effects, good and bad, of low dose weekly cisplatin and     gemcitabine.   "
95925|NCT02030561|"     This study will determine the safety and efficacy of expanded activated autologous NK cells     administered after Trastuzumab in patients with HER2-positive breast or gastric cancer. It     will also provide valuable insights of the role of NK cell infusions in adult solid tumors.   "
95926|NCT02030548|"     The aim of the study is to evaluate surgery-related bleeding and mortality in patients     needing acute coronary artery bypass grafting with or without valve replacement during dual     antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel,     Ticagrelor)   "
95927|NCT02030535|"     The primary objective of this study is to evaluate the efficacy and safety of orally inhaled     tiotropium and olodaterol as both a fixed dose combination and a free combination with     respect to lung function and ECG parameters   "
95928|NCT02030522|"     This is a prospective cohort treatment intervention study (n=200) whereby U.S. service     members and veterans with symptoms of PTSD will undergo 2-5 sessions of ART delivered by     Florida licensed mental health professionals trained in ART. The 3 study aims are to: (i)     evaluate among U.S. service members and veterans overall, and within specific subgroups, the     magnitude of change in symptoms of PTSD following treatment with ART; (ii) evaluate the     sustainability of treatment response with ART; and (iii) evaluate the cost effectiveness of     ART compared to prolonged exposure (PE) therapy in the treatment of symptoms of PTSD.   "
95929|NCT02030509|"     Head and neck cancer would be suitable for quick diagnostic programs because their initial     symptoms are easy detectable and the curation rates in the initial stages are very high.      Actually the stages at diagnosis are about 30% in initial stages and 70% in advanced stages.      The hypothesis of this study is that a program for quick referral of patients with symptoms     of head and neck cancer would help early diagnosis.   "
95942|NCT02030340|"     Various systems to measure intravesical and intrarectal pressure during urodynamic testing;     especially cystometry, exist. Water filled tube -systems are the most commonly used and     should be regarded as the contemporary standard. A water filled system is however sensitive     to tube and or patient movement artefacts and prone to erroneous calibration. Air charged     catheters are less sensitive to patient and especially tubing- movements, and calibrate     easier. However, in vitro tests have demonstrated that air charged catheters respond somewhat     slower and relatively damped, especially to rapid pressure changes as in (simulated)     coughing, in comparison with water filled systems. The clinical relevance of these     observations is unknown.      This is a study to compare the technical reliability and clinical applicability of the two     types of catheter systems for cystometry in a synchronous double catheter testing procedure     in a prospective group or patients scheduled for urodynamic investigation.   "
95930|NCT02030496|"     BACKGROUND:      Fractures of the distal radius are common and account for an estimated 17% of all fractures     diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal     radius fractures are considered to be relatively harmless, inadequate treatment may result in     impaired function of the wrist. The consequences of post-traumatic loss of function are     comprehensive, both on an individual and a social level, and have long been underestimated.     Despite the substantial implications, no evidence-based treatment method yet exists. Good     results have been described both in patients treated conservatively and surgically.     Nevertheless, 60% of all fractures redislocate after conservative treatment at which point     surgical reduction and fixation is the treatment of choice. Recently, the use of volar     locking plates has become more popular. This type of osteosynthesis employs a volar approach     to the wrist and provides immediate stable fixation of the reduced fracture. This stability     allows for early mobilisation and may therefore result in an improved regain of function. The     aim of this study is to compare the functional outcome following surgical reduction and     fixation with a volar locking plate with the functional outcome following closed reduction     and plaster immobilisation at one year follow-up in patients with displaced extra-articular     distal radius fractures.      DESIGN:      This single blinded randomised controlled trial will randomise between open reduction and     internal fixation with a volar locking plate (intervention group) and closed reduction     followed by plaster immobilisation (control group). The study population will consist of all     consecutive adult patients who are diagnosed with a displaced extra-articular distal radius     fracture which has been adequately reduced at the Emergency Department. The primary outcome     (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score     (DASH). Since the treatment allocated involves a surgical procedure, randomisation status     will not be blinded. However, the researcher assessing the outcome at one year will be     unaware of the treatment allocation. In total, 90 patients will be included in this trial     which will be conducted in the Academic Medical Centre Amsterdam and its partners of the     regional trauma care network.   "
95931|NCT02030483|"     Our hypothesis is that treating relapsed or refractory multiple myeloma with PD 0332991     (Palbociclib) in combination with lenalidomide will result will be both effectively inducing     myeloma plasma cell death as well maintaining a favorable side effect profile.   "
95932|NCT02030470|"     Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues     leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for     periodontal diseases display more or less pronounced persistence of periodontal tissue     infection, inflammation, and destruction. The therapeutic additional value of photodynamic     anti-infectious treatment remains controversial. The objective of this study is to evaluate     the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment     outcomes and to define its specific therapeutic indications.   "
95933|NCT02030457|"     This study is designed to compare the systemic exposure of orally inhaled beclomethasone     dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.   "
95934|NCT02030444|"     The overall aim of this study is to compare standard staging of lung cancer (which includes     clinical examination, CT, MRI, bone scan and PET-CT) with comprehensive staging - which     includes the new staging methods (PET-MRI and systematic mapping of mediastinal and hilar     lymph nodes using endobronchial ultrasound) with respect to disease stage and outcomes of     therapy.   "
95935|NCT02030431|"     A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared     with three cancellous screws, for osteosynthesis of femoral neck fractures   "
95936|NCT02030418|"     Prospective, non-randomized, single-arm, international multicenter, clinical safety and     effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR     pacemaker.      Following completion of enrollments in the IDE, patients will continue to be enrolled in the     continued access phase of the study under the same protocol.   "
95937|NCT02030405|"     This phase 2 trial studies how well ixazomib(MLN9708) works in treating patients with     relapsed or refractory acute myeloid leukemia. Ixazomib may stop the growth of cancer cells     by blocking some of the enzymes needed for cell growth.   "
95938|NCT02030392|"     This trial aims to compare two training programs for children suffering functional abdominal     pain. These two programs are comparable in number of sessions and group sizes, but show     differences in content (very focused on pain management vs. more general information and     support). Focus of the trial is the evaluation of Stop the pain, which has shown high     effectiveness in one first trial. This time, five clinics, experienced in diagnosis and     treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are     eligible. The programs imply six weekly group sessions for the children and 2 parent     evenings. The study group assumes that participation in Stop the pain will reduce pain     experience and will improve the children's quality of life and coping strategies - up to 12     months after training.   "
95939|NCT02030379|"     The investigators will leverage e-technologies to provide an online version of the Question     Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time     prioritizing of patient questions as well as the seamless delivery of these questions to     their treating physician (and other members of their clinical team) via the VCU Health System     (VCUHS) patient portal, and the electronic medical record (EMR) prior to a consultation to     discuss a clinical trial   "
95940|NCT02030366|"     Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such     as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in     patients who can benefit from evacuation procedures can lead to worse brain injury, worse     outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive method     for diagnosis of TBI severity in the field. In this study we will examine the feasibility of     using this a multifocal chromatic pupillometer for monitoring TBI, by examining the pupillary     response to multifocal chromatic stimuli in intracranial pressure (ICP)-monitored severe TBI     patients. As control, normal subjects will be tested for pupillary responses using this     device.   "
95941|NCT02030353|"     The purpose of this study is to test the feasibility of two 6-month behavioral interventions     for weight gain prevention (self-regulation plus activity monitoring or self-regulation)     among African American breast cancer survivors along with a delayed control group.     Participants will be 45 African American post-treatment breast cancer survivors. Intervention     content will be delivered online with one face-to-face individual meeting. Weight, clinical     and psychosocial measures will be assessed at baseline, 3 and 6 months. It is hypothesized     that it is feasible to deliver the two weight gain prevention interventions among African     American breast cancer survivors, and participants in the two intervention groups will have a     lower magnitude of weight gain at 6-month follow-up relative to those in the delayed control     group.   "
95943|NCT02030327|"     To analyse differences in protein expression in multiple trauma patients for identification     of potential biomarkers to predict organ dysfunction.   "
97067|NCT02015663|"     To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation     Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic     fibrosis.   "
95946|NCT02030288|"     This project will involve the development and initial evaluation of a promising     computer-based intervention to improve the primary care management of risky alcohol use among     Veterans. The intervention uses a Relational Agent, an on-screen person that establishes a     relationship with the Veteran to promote positive health behaviors. This study will determine     how Veterans interact with this system, how it can be tailored to Veterans' preferences, and     its potential effect on risky drinking. If ultimately proven effective, the Relational Agent     will have several impacts on Veterans and their health care, including:        -  (1) lower rates of risky drinking in Veterans        -  (2) improved rates of brief counseling for Veterans with excessive alcohol use        -  (3) increased proportion of Veterans referred to Mental Health for alcohol disorders        -  (4) improved care for Veterans with low levels of health literacy.      This study directly supports Secretary Shinseki's Transformational Initiative to employ     state-of-the-art information technology to improve quality and access of Veterans' health     care.   "
95947|NCT02030275|"     The purpose of this study is to determine the effectiveness of RXI-109 in reducing the     recurrence of hypertrophic scar formation following elective revision of a pre-existing     hypertrophic abdominal scar.   "
95948|NCT02030262|"     The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride)     is better than the other in epiretinal membrane peeling surgery. Both are already used for     this surgery and this study will tell us if one is better than the other.   "
95949|NCT02030249|"     The aim of this study is to investigate possible enduring effects of a standard 2-month     weight loss program on appetite regulation, bone homeostasis and muscle strength in younger     and older adults, as well as the impact of differences in dietary composition during weight     maintenance.   "
95950|NCT02030236|"     Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees     Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain     function after return of spontaneous circulation when someone has been resuscitated from     cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.      The device is a prototype cooling vest. The investigators anticipate that this will be useful     in ambulances, helicopters and emergency departments where there is a need for a portable,     safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient     use device able to reduce body temperature by at least 1 degree Centigrade an hour to     initiate cooling. What the investigators are doing in these trials is to demonstrate that the     investigators can cool people and to get the best design possible for patient use. That means     some of the initial prototypes will not resemble what we expect the eventual device to look     like. The investigators will be undertaking the initial trials on 30 normal volunteers.   "
95951|NCT02030223|"     This prospective, randomized, double blinded, placebo-controlled study is designed to     evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis     plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair     with a mesh under general anaesthesia, and how the efficiency of early postoperative     analgesia achieved correlates with the risk of developing a chronic pain state, a not     uncommon condition after this type of surgery.   "
95952|NCT02030210|"     RAND/UCLA modified Delphi study on quality indicators for STEMI to determine the     appropriateness of quality indicators retrieved from literature and guideline review. We aim     to engage 20 cardiologists and 20 nurses with relevant experience in the care for STEMI     patients.   "
95953|NCT02030197|"     The purpose of this study is to examine the effects of an innovative program, entitled CRISP     (Community Integration for Socially Isolated Patients), on improving self-efficacy and     assessing whether improved self-efficacy helps to reduce depression and loneliness of people     with MS.   "
95972|NCT02029950|"     This phase I trial studies the side effects and best dose of pomalidomide after combination     chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or high-risk     myelodysplastic syndrome. Drugs used in chemotherapy, such as cytarabine, daunorubicin     hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Pomalidomide may kill cancer cells by stopping blood flow to the cancer and by     stimulating white blood cells to kill cancer cells. Giving more than one drug (combination     chemotherapy) and pomalidomide may kill more cancer cells.   "
100309|NCT01973166|"     The purpose of this study is to compare the investigational medical grade laser device to a     marketed medical grade laser device for effectiveness in lightening or clearing unwanted     tattoos. This study will also compare any side effects from treatment with the devices.   "
95954|NCT02030184|"     There are two parts to this trial. The first study will evaluate increasing doses of Re188     P2045 in patients with advanced small cell lung cancer that has recurred after initial     therapy or in patients with other advanced neuroendocrine cancers that have progressed after     therapy.      Re188 P2045 is designed to attach to type 2 somatostatin receptors that are frequently     expressed in those cancers and then the radioactivity from Re188 will kill the cancer cell.     Only patients who have cancers that can be seen when Tc99 P2045 is administered (also seeks     out the SSTR2, but Tc99 images, but does not treat the cells) will be treated.      Therefore, this approach maximizes the possibility that patients will benefit from treatment     in that only those who have cancers that have the target will undergo treatment. The primary     purpose of this study will be to determine the highest dose of Re188 P2045 that can be safely     administered.      The second study will open after the conclusion of the first. Patients will first undergo the     scan with Tc99 P2045 and then be treated with topotecan for three days. Topotecan is a     standard chemotherapy drug that is approved for second line therapy for small cell and     frequently used for other neuroendocrine cancers. Following that, patients will then be     re-evaluated with the Tc99 P2045 scan and if it demonstrates that the tumor is positive for     SSTR2, then patients will receive Re188 P2045. The goal of this study is to determine the     highest dose of Re188 P2045 that can be safely administered after topotecan as well as to     determine if topotecan will increase the chance that the tumor will express SSTR2.   "
95955|NCT02030171|"     Effect of three therapeutics strategies on the restriction of the participation of patients     with a chronic back pain : multidisciplinary is it the key component ?   "
95956|NCT02030158|"     This is the statistical analysis plan for an individual patient data meta-analysis (IPDMA) of     three EGDT clinical trials.   "
95957|NCT02030145|"     The primary goal of this line of research is to see if realistic manipulative protocols can     be developed to produce sustained reductions in residual volume and improve pulmonary     function parameters in people with Chronic Obstructive Pulmonary Disease (COPD).   "
95958|NCT02030132|"     Employers are increasingly looking for opportunities to motivate sedentary employees to     become more physically active. Workplace walking programs have had mixed success and     typically show most improvement among participants that are already fairly active at a     baseline. The goal of this study is to determine whether a financial incentive program can     motivate sedentary employees to increase the number of steps they walk per day to meet a     minimum threshold.      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed     by 3 months of follow-up without incentives. Secondary outcomes will include the average     steps walked per day.   "
95959|NCT02030119|"     Employers are increasingly looking for opportunities to motivate sedentary employees to     become more physically active. Workplace walking programs have had mixed success and     typically show most improvement among participants that are already fairly active at a     baseline. The goal of this study is to determine whether a financial incentive program can     motivate sedentary employees to increase the number of steps they walk per day to meet a     minimum threshold.      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed     by 3 months of follow-up without incentives. Secondary outcomes will include the average     steps walked per day.   "
95960|NCT02030106|"     This is a prospective cohort, enriched with women with a prior term birth, of singleton     pregnancies who will be followed for the outcome of preterm birth. The main exposure of     interest is the characterization of the cervico-vaginal microbiota. Women will be recruited     from a population seeking routine obstetrical care at obstetrical practices at Penn. They     will have three research visits during pregnancy to complete questionnaires and collect     samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the     prenatal events and timing of delivery.   "
95961|NCT02030093|"     Alcohol dependency is the second most common psychiatric disorder and a major public health     concern. As addictive disorders and now thought to be chronic disorders for many patients     there is a need for the development of expanded treatment approaches. Because relapse is more     often the rule than the exception the importance of continuing care after an initial phase of     treatment is evident. Studies investigating telephone-based continuing care for patients with     alcohol dependence have shown to be an effective form of step-down treatment after a previous     stabilisation treatment program and provide extended recovery support. Therefore, the     investigators hypothesize that alcohol abstinent patients who received high-frequency     telephone-based or sms-based continuing care show significantly less relapses respectively     more abstinent days six and twelve months after in-patient treatment compared to patients who     receive low-frequency or no telephone-based continuing care.   "
95962|NCT02030080|"     Employers are increasingly looking for opportunities to motivate sedentary employees to     become more physically active. Workplace walking programs have had mixed success and     typically show most improvement among participants that are already fairly active at a     baseline. The goal of this study is to determine whether a financial incentive program can     motivate sedentary employees to increase the number of steps they walk per day to meet a     minimum threshold.      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed     by 3 months of follow-up without incentives. Secondary outcomes will include the average     steps walked per day.   "
95963|NCT02030067|"     The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects     with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to     estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory     pancreatic or advanced bladder cancer).   "
95973|NCT02029937|"     The overall objective of this multicenter trial is to determine whether the use of a     low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the     efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This     is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3, 500)     microscope device which can be used during upper endoscopy to image the gastrointestinal     epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at     RICE University and provides >1000X magnified images of the esophageal mucosa.   "
95964|NCT02030054|"     Statin interference has been suggested among the mechanisms of reduction of the antiplatelet     effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of     rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery disease     undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a single-center,     prospective, randomized, crossover study conducted in the Department of Heart and Great     Vessels Attilio Reale, Sapienza University, Rome, Italy. All consecutive patients undergone     PTCA in our institution in the period between July 2013 and December 2013 will be eligible to     be enrolled.      Patients will be offered to participate to the trial at time of 1-month post-angioplasty     follow-up visit.patients receiving dual antiplatelet therapy (prasugrel 10 mg or brilique 90     mg x 2 plus aspirin 100 mg) after percutaneous coronary intervention. Patients were randomly     assigned to rosuvastatin (20 mg day) or atorvastatin (40 mg day) for 30 days. After 1-week     wash-out period to avoid any carryover effect, cross-over was performed, and patients were     switched to the other drug which was continued for 30 days.      Platelet function will be evaluated using a validated method: the VerifyNow System     (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical     detection system that measures platelet-induced aggregation. Platelet function will be     measured with the VerifyNow P2Y12 test at baseline and after 30 days from rosuvastatin or     atorvastatin administration.      Platelet reactivity will be expressed in P2Y12 reaction units (PRU). PRU values >208 are     suggestive of high platelet reactivity.   "
95965|NCT02030041|"     Statins along with lifestyle modifications including exercise are commonly prescribed to     patients with type 2 diabetes. American diabetes association recommends using     moderate-intensity statin and lifestyle therapy for patients with diabetes aged ≥40 years,     even without additional cardiovascular disease(CVD) risk factors.. Myopathy is a well known     adverse effect of statins, which occurs in 1-7% of patients. The spectrum of statin-related     myopathy ranges from common benign myalgia to rare but life threatening rhabdomyolysis. Being     lipophilic, simvastatin diffuses nonselectively into extrahepatic tissues such as muscle,     leading to higher incidence of myopathy among statin users.      In addition, simvastatin attenuates the exercise-induced increase in cardiorespiratory     fitness, and reduces the skeletal muscle mitochondrial content and oxidative capacity in     humans. Impaired cardiorespiratory fitness and mitochondrial function is possibly due to     reduction in Coenzyme Q10, which is a component of the electron transport chain and is     indispensable for generation of adenosine triphosphate (ATP) during oxidative phosphorylation     in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors     interfere with the production of mevalonic acid, which is a precursor in the synthesis of     coenzyme Q10.      Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has     been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the     oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression).     Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and     mitochondrial function by improving the enzymatic machinery involved in oxidative     phosphorylation which is blocked by statin. This study is being done to look for the effect     of vitamin D supplementation on simvastatin-mediated change in exercise-mediated     cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2     diabetes   "
95966|NCT02030028|"     The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease     the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking     medications prescribed by their physician and are still experiencing disease symptoms.      ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis     since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite     its FDA approval there is very limited data on its how well ACTH gel works in improving the     symptoms of people with RA.   "
95967|NCT02030015|"     The investigators hypothesize that a combination therapy using miglustat and the ketogenic     diet for infantile and juvenile patients with gangliosidoses will create a synergy that 1)     improves overall survival for patients with infantile or juvenile gangliosidoses, and 2)     improves neurodevelopmental clinical outcomes of therapy, compared to data reported in     previous natural history studies. The ketogenic diet is indicated for management of seizures     in patients with seizure disorders. In this study, the ketogenic diet will be used to     minimize or prevent gastrointestinal side-effects of miglustat. A Sandhoff disease mouse     study has shown that the ketogenic diet may also improve central nervous system response to     miglustat therapy (see Denny in Citations list below). Patients with infantile and juvenile     gangliosidoses commonly suffer from seizure disorders, and use of the ketogenic diet in these     patients may therefore also improve seizure management.   "
95968|NCT02030002|"     The purpose of this study is to compare bonding time, bond survival, amount of adhesive     remaining on the tooth surface after bracket debonding, and time required for adhesive     remnant cleanup between a new flash-free and a conventional adhesive resin for orthodontic     bracket bonding.   "
95969|NCT02029989|"     The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care     (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome.     Subjects were also randomized to either an Extended Treatment Group (ETG) defined by     receiving comprehensive medication management (CMM) pharmacist interventions or a Usual     Treatment Group (UTG) receiving no CMM interventions. All subjects were recruited from three     community mental health clinic settings in Minnesota.   "
95970|NCT02029976|"     Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight     management program to reduce excess weight gain among children, 8 to 12 years old who are     overweight and at risk of overweight by increasing healthy dietary practices and physical     activity levels and decreasing sedentary practices.      Primary Hypothesis: Relative to the control condition, the children receiving the     intervention will have a significantly lower body mass index (BMI), following implementation     of the 9-month intervention, controlling for baseline values.   "
95971|NCT02029963|"     The purpose of this study is to investigate the use of repetitive transcranial magnetic     stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known     to be an effective treatment for major depressive disorder, but there is also evidence that     it may be effective in the maintenance of remission following treatment. However, it is not     yet clear what maintenance strategy will yield the best outcome in preventing relapse.      In this study, eligible patients who have finished one full course of rTMS for treatment of     major depression will be randomized into three groups: (i) cluster rTMS, (ii) taper rTMS, and     (iii) treatment as usual. The 'cluster rTMS' group will receive two weeks to daily rTMS six     months after the completion of their regular rTMS treatment, the 'taper rTMS' group will     receive three sessions a week for two weeks followed by two sessions a week for two weeks     immediately following their regular rTMS treatment, while the 'treatment as usual' group will     receive standard follow-up care from their own psychiatrist and/or primary care doctor.      The investigators hypothesize that the group with cluster treatment will show significantly     lower relapse rates in depressive symptoms as compared to the other groups.   "
95974|NCT02029924|"     The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the     duration of action of insulin lispro due to a facilitation of the absorption of the insulin     after subcutaneous injection.      The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in     subjects with Type 1 diabetes under a dose of 0.2 U/Kg.      This trial is a single-center, randomised, double-blinded, two-treatment, two-period     cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus.     Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2     U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.   "
95975|NCT02029911|"     This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical     study is designed as a non-inferiority study to assess the effectiveness of the Aurora     Endometrial Ablation System compared to an objective standard. Safety will be evaluated by     determining the number and percentage of subjects who experience one or more of serious     adverse events.   "
95984|NCT02029794|"     Cervical cancer remains a public health burden, particularly in developing countries such as     sub-saharan Africa where the infrastructure for organized screening programs does not exist.     As a result, other screening modalities (visual inspection with acetic acid) are the standard     of care in such regions. It is now known, persistent infection with an oncogenic Human     papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing     HPV testing is a potential, safe and effective alternative to cytology testing (The Pap     smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs.     VIA in a cohort of women from Kisenyi, Uganda.   "
96414|NCT02024178|"     This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients     undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and     diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning     technology for the purpose of determining its ability to identify sites of prostate cancer at     the time of prostate ultrasound.   "
95977|NCT02029885|"     To demonstrate that non-invasive renal denervation is safe and shows a net difference in     blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.   "
95978|NCT02029872|"     This research is being done to learn more about an approach to remove Methicillin resistant     Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient     settings and among their household members and sexual partners.      MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make     people very sick. The bacteria have been seen in a high number of persons in the Baltimore     area and in hospitals throughout the country. MRSA can be spread from person to person,     particularly in homes and among family members and sexual partners.      There are three things the investigators hope to learn from this research study:      First, the investigators want to find a way to prevent MRSA infections in outpatient     settings. By asking questions, the investigators want to look at the things that may increase     the risk of having this type of bacteria in you and your family members.      Second, the investigators have soaps and oral rinses (Chlorhexidine) and medications     (antibiotics; Mupiricin ointment) that have been shown to be effective at removing MRSA. The     investigators want to determine if these antibiotics and soaps are best used for everyone in     the household or only the individual with known MRSA.      Third, as the investigators, we want to learn more about the bacteria by looking at it on the     inside. The investigators will do laboratory tests on samples we collect, to learn how MRSA     bacteria grow, reproduce and how it develops to behave differently than other types of MRSA     bacteria.   "
95979|NCT02029859|"     Main objective:      Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a     population of obese patients .      Secondary objectives :        -  Identify risk factors for OSA during pregnancy (age, parity, high blood pressure,          snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .        -  Compare perinatal morbidity among obese patients with OSA in late pregnancy with          case-controls.        -  Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.      Material and methods      Characteristics of the study:        -  Interventional biomedical research        -  Prospective Multicenter nonrandomized study      Flow chart        -  Patients will be included between 30 and 36 weeks of amenorrhea (WA) .        -  Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck          circumferrence, treated high blood pressure.        -  As recommended in France, the main test results during the pregnancy follow-up will be          recorded.        -  At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.        -  Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA.          This screening can be performed as an outpatient.        -  In case of proven OSA patients will be offered an appropriate care by today's standards.        -  Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months          after childbirth in case of OSA during pregnancy.   "
95980|NCT02029846|"     This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients     conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology     Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen     base solely on traditional drugs, a regimen including newer drugs will achieve glycemic     target faster and induce less hypoglycemia, weight gain, and other side effects, over the     short run.   "
95981|NCT02029833|"     The objectives of the study are to examine the health benefits of dietary canola oils on body     composition, specifically on android fat, and weight management. COMIT II will also include     analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body     composition. Measurement of endothelial function, inflammatory, adiposity, and insulin     sensitivity biomarkers will be done to determine the positive health impact of the changes in     body composition achieved through canola oil consumption.   "
95982|NCT02029820|"     The purpose of this study is to determine whether hydration with intravenous saline matched     with urine output, using the device RenalGuard is superior to standard hydration with saline     to prevent contrast-induced nephropathy.   "
96075|NCT02028611|"     There were many studies which examined the availability of inverted gray-scale chest X-ray     for increasing the detection of lung nodules. In emergency medicine, rib fracture is an     important part for patient's disposition, so investigators designed this study to evaluate     the availability of inverted gray-scale chest X-ray for the detection of rib fracture.   "
95983|NCT02029807|"     The investigators have developed a system based on a pulse oximeter, a tablet, and an     algorithm running on the tablet that analyzes the pulse oximeter waveform.      The algorithm that runs on this system should be able to accurately keep track of blood loss     during blood donation. The investigators will compare the algorithm with the blood loss     tracked by a device called a flow meter.      The algorithm that runs on this system should be able to accurately keep track of stroke     volume changes. The investigators will compare the algorithm with the stroke volume changes     tracked by a device called a CCNexfin.      The algorithm that runs on this system should work whether it's in place for the whole blood     donation, or if it's placed after the blood donation has started. The investigators will use     two pulse oximeters for the system on each hand and compare one that is used for the whole     blood donation versus one that is not used for the whole blood donation.   "
97132|NCT02014805|"     The purpose of this study is to determine whether postoperative conformal radiotherapy are     effective in the treatment of Masaoka stage II-III B type thymoma.   "
95985|NCT02029781|"     SUMMARY      Rationale: A diagnostic laparoscopy is a frequently used method to confirm the diagnosis     appendicitis. However until recently evidence-based laparoscopic criteria for determining     appendicitis were not defined. If there is any doubt about the presence of appendicitis the     appendix is usually removed. In a single centre prospective pilot study on 134 patients the     investigators were able to define the Laparoscopic APPendicitis (LAPP) score. In the current     study the investigators will validate the LAPP score in order to decrease the negative     appendectomy rate by 50%. Eventually the score should lead to a decrease in morbidity.      Objective: To decrease the negative appendectomy rate by 50%.      Study design: A multicenter prospective validation study      Study population: All patients, ≥18 years, operated with a diagnostic laparoscopy for the     clinical suspicion appendicitis. Sample size calculation, performed by a statistician/     epidemiologist of the Trial Coordination Centre, showed the need to analyse 778 patients.      Intervention (if applicable): Patients operated on appendicitis in 2008 and 2009 (n=843),     were retrospectively analysed for negative appendectomies. This cohort will serve as the     control group. In this control group no intervention was given, as the LAPP score was not yet     defined.      In the 778 prospective analysed patients, the LAPP score will be used during a diagnostic     laparoscopy. With the LAPP score the investigators intend to halve the number of negative     appendectomies.      Main study parameters/endpoints: A decrease in the negative appendectomy rate from 9% to 5%.     This decrease should not lead to an increase in missed appendicitis (occurring within 30     days), defined as requiring a surgical re-intervention or as an appendicitis or appendicular     infiltrate on an ultrasound or CT-scan.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The risk of implementation of the LAPP score is minimal. In theory, the use of     the LAPP score might lead to an increase risk in missed appendicitis. This might lead to an     increase in morbidity.   "
95986|NCT02029768|"     Hypothesis 1: A quantifiable difference in inflammatory cytokines exist in women with burn     injury and this correlates with clinical markers of outcome      Hypothesis 2: The amount of adipose tissue contributes to the severity of cellular immune     response (CMI) dysregulation in response to burn injury      Skin-fold caliper measurements will be taken on consented patients (both male and female) to     determine body fat percentage. Serum samples will be obtained from these patients. The level     of inflammatory cytokines in the serum will be measured to determine if there is a link     between body fat percentage, pro-inflammatory cytokines and the ability of women to survive     burn injury.   "
95987|NCT02029755|"     Postoperative analgesia is an important part of the anesthetic care. According to the recent     studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer     side effect. For example, combining intravenous, intramuscular or oral analgesics with     transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the     multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.      For abdominal surgery, both local infiltration and TAP block target on relieving somatic     pain. Local anesthetic wound infiltration is easy to perform with low risk. As the     advancement of ultrasound technology, performing the TAP block also becomes easier, safer and     more accurate. But whether LA infiltration or TAP block is better for the multimodal     analgesia regimen remains unclear.      This study is to compare the postoperative pain score, opioid consumption, side effects, and     quality of recovery between these two analgesic methods in patients undergoing abdominal     surgery. The investigators hypothesized that TAP block may be more effective than LA     infiltration as a part of the multimodal analgesia, and can improve the recovery after the     abdominal surgery.   "
95988|NCT02029742|"     The investigators propose that culturally aligned community-based interventions in our     multi-ethnic sickle cell disease (SCD) population, augmented by task-focused communication     technology, can improve self-managed adherence to hydroxyurea (HU) by decreasing barriers to     use, supporting parent-youth partnerships for chronic disease self-management and reinforcing     the behavior of daily medication use. Culturally aligned community health workers (CHW) are a     well-established means to support chronic disease self-management by underserved families, in     partnership with medical homes. CHWs can identify and address multiple barriers and reinforce     developmentally appropriate self-management to help youth reach and maintain their best fetal     hemoglobin (HbF) levels. However, this strategy alone may be insufficient to achieve daily HU     adherence. The investigators therefore propose a feasibility trial to test the feasibility     and acceptability of a structured intervention of CHW support to address existing barriers to     improve HU use, augmented by daily cue-based parent and youth text message reminders, to     efficiently extend CHW family support and reinforce family partnerships for self-management.   "
95989|NCT02029729|"     This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum     tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients     with advanced solid tumors that are refractory after standard of care therapy for the     disease. The results of this study will help provide clinical information for the design and     conduct of further clinical studies with RTA 408 in cancer patients.   "
96008|NCT02029482|"     This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1     study. Sixteen subjects in two groups (at least 40% of subjects of either male or female     sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to     100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending     doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60     mg, 80 mg, and 100 mg.   "
96009|NCT02029469|"     It is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are     treated with the Ascension® HRA. Its purpose is to measure and document the outcomes     associated with implanting the Ascension HRA prosthesis. Patients will be periodically     assessed to collect data related to safety and effectiveness endpoints at the following     intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5     year, and 10 years.   "
96010|NCT02029456|"     The aim of the present study was to assess the effects of low-dose (25mg) prolonged     administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital     mortality and outcomes in patients with massive PE.   "
95990|NCT02029716|"     This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a     novel small molecule which suppresses oxidative stress and inflammation. In this study, the     safety, local pharmacodynamics (PD), and systemic pharmacokinetics (PK) of RTA 408 will be     evaluated following topical application of RTA 408 Lotion to healthy volunteers. This study     will be conducted in three parts. In Part A of the study, healthy volunteers will have RTA     408 Lotion Vehicle and RTA 408 Lotion (0.5%, 1%, and 3%) applied to a small skin surface area     (four individual 4-cm2 sites; 16 cm2 total area) twice daily for 14 days to assess the local     skin tolerability, local PD, and systemic PK of these treatments. Part B will be conducted     after completion of Part A and will assess the safety, tolerability, local PD, and systemic     PK of RTA 408 Lotion applied topically twice daily for 14 days to a larger skin surface area     (~100 cm2). Part C will be conducted after completion of Part B and will assess the safety,     tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically twice daily for     28 days to a larger skin surface area (~500 cm2). The maximum tolerated drug concentration in     Part A will be used in Part B and Part C.      Approximately 32 healthy adult volunteers will be enrolled in this study with 12 volunteers     in Part A and 10 volunteers each, in Parts B and C.   "
95991|NCT02029703|"     The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance     and performance, resulting in improved knee function and pain when compared to a group that     receives a sham injection (an injection that does not have medicine) only before a     standardized physical therapy regimen over 10 weeks.   "
95992|NCT02029690|"     A study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme in     patients with histologically proven advanced malignant pleural mesothelioma (MPM), advanced     peritoneal mesothelioma (in dose escalation cohort only), non-squamous non-small cell lung     carcinoma stage IIIB/IV (NSCLC), metastatic uveal melanoma, hepatocellular carcinoma (HCC),     glioma and sarcomatoid cancers   "
96023|NCT02029287|"     The purpose of this study is to determine whether the Hospital-Community-Family-Care     Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and     costs of the subjects with CHF.   "
95993|NCT02029677|"     The purpose of this research study is to determine how changes in levels of obesity-related     hormones in the gastrointestinal tract following Laparoscopic Adjustable Gastric Banding     (LAGB) surgery may lead to a decrease in appetite and weight loss. Learning exactly how the     Lap Band works may help us to develop new, less invasive treatments for morbid obesity. This     knowledge may also lead to the development of preventive, cost-effective treatment     strategies. As a control subject, participants will provide a comparison for changes in these     hormones with medical weight loss compared to weight loss after LAGB surgery.   "
95994|NCT02029664|"     The purpose of this study is to determine the possibility of gait pattern change via visual     feedback among patients with stroke. Also, the optimal visual feedback would be chosen from     this study.   "
95995|NCT02029651|"     The purpose of this study is to determine whether novel upper extremity rehabilitation system     for patients with stroke(e-glove system) are effective in the rehabilitation compared to     conventional occupational therapy   "
95996|NCT02029638|"     The purpose of this study is to find out if the study treatment will allow people to accept     their new kidney and be able to stop taking anti-rejection medications.   "
95997|NCT02029625|"     The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration     of rosuvastatin and ezetimibe.   "
95998|NCT02029612|"     The goal of this research study is to compare 2 different phone-based programs for quitting     smoking for people with HIV/AIDS.   "
95999|NCT02029599|"     The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi     granules in subjects with Rheumatoid Arthritis.   "
96000|NCT02029586|"     This is a controlled study to determine the effectiveness and safety of MB12066 in the     treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.   "
96001|NCT02029573|"     The purpose of this study is to explore the efficacy and safety of Atorvastatin in     combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed     by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The     anticipated time on study treatment is until disease progression, and the target sample size     is 32 individuals.   "
96002|NCT02029560|"     To evaluate effect on cardiovascular system(blood pressure) when Thrupas® capsule is     administered every day for 12 weeks in patients with Lower Urinary Tract Symptoms suggestive     of Benign Prostatic Hyperplasia   "
96003|NCT02029547|"     This study is designed to validate the Japanese electronic florbetapir (18F) interpretation     training program intended for post-approval implementation in Japan.   "
96004|NCT02029534|"     This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the     prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that     80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20     mg.   "
96005|NCT02029521|"     Many individuals with cystic fibrosis experience growth failure. The reasons are not clear,     but inflammation of the gut in these patients seems to be one important reason. Glutathione     is important to normal function of the intestine and lungs. Glutathione functions to decrease     inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets trapped inside     of cells, so it cannot travel to the surface of the cells and perform its proper function.     Moreover, glutathione has been shown to improve nutritional status in patients with AIDS and     cancer.      Investigators hypothesize that supplementation of oral glutathione to pediatric individuals     with cystic fibrosis could improve growth failure.   "
96006|NCT02029508|"     The purpose of this study was to compare the treatment effectiveness of three different     methods for posterior semicircular canal benign paroxysmal positional vertigo. The included     methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.   "
96007|NCT02029495|"     The primary objective of this study is to evaluate the efficacy of brodalumab, compared to     placebo, in subjects with psoriatic arthritis.   "
96011|NCT02029443|"     This study is evaluating the safety and efficacy of a new Bruton tyrosine kinase (Btk)     inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small     lymphocytic lymphoma (SLL)   "
96024|NCT02029274|"     This study investigates the dose response relationship for the efficacy and safety of BAF312     compared to placebo in active DM patients over a treatment period of 6+6 months and to     determine the minimum dose required for a maximal clinical effect. The study is composed of 2     periods: a double-blind period I with BAF312 administered at different daily doses (0.5, 2,     10 mg and placebo) and a fixed-dose Period II in which BAF312 will be administered at the     dose of 2 mg daily .   "
96025|NCT02029261|"     The purpose of this study is to examine important and significant problems, that of insulin     resistance and muscle wasting after burn injury.   "
96014|NCT02029404|"     We will enroll patients submitted to feet elective orthopaedic surgery that require analgesia     through continuous peripheral nerve block (CNPB) of the sciatic nerve. All catheters will be     placed by anaesthesiologists experienced in ultrasound in prone positioning. The patients     will be randomized in two groups with technique of sealed envelopes.      In the tibial -peroneal nerve (TPN) group we will position the catheter within the confluence     of peroneal and tibial nerve.      In the tibial nerve (TN) group we will proceed , previous local anaesthesia, to insert a     catheter medially to tibial branch of the sciatic nerve according to in plane approach.      We will analyze A: the difference in consumption of local anesthetic in the two different     groups B: the difference of insensate limb in the post-operative home as described by     Ilfeld(inability to perceive the sense of touch throughout the area of distribution of the     sciatic nerve) C: rate of foot drop D: numeric rate scale (NRS) for pain assessment, rate of     dislodgment of the catheters, patient satisfaction, need for intervention by the     anesthesiologist after discharge.   "
96015|NCT02029391|"     Musculoskeletal dysfunction is considered as a major public health problem affecting about     one third of the adult population. Myofascial pain syndrome (MPS) characterized by myofacial     trigger points as well as fascia tenderness are thought to be the main cause of     musculoskeletal dysfunction. The aim of the treatment for musculoskeletal dysfunction is to     reduce pain and restore normal function. Clinically, some evidence supports the application     of kinesio tape in these patients. The underlying mechanism, however, is not clear. The     investigators goal was to validate proposed mechanism of kinesio tape in these patients. The     primary outcome are muscle stiffness, pain intensity and sensitivity.   "
96016|NCT02029378|"     Guillian-Barre Syndrome (GBS) is the most frequent cause of acute neuromuscular weakness in     the Western World and can occur at any age. GBS is a rpadily progressive 'inflammatory'     disorder of the perihperal nerves often leading to sever paresis of the limbs. Most GBS     patients also have sensory disturbances (tingling or dull feeling) and pain. Some patients     also have double vision or problems with swallowing. GBS mau also involve the respiratory     muscles, leading to insufficient ventilation and admission to an intensive care unit. GBS     pateints have a vairable prognosis; 20-30% require mechnical ventilation for a period ranging     from weeks to months, 20% are unable to walk after 6 months nad 3-5% dies. Progression of     weakness in GBS is usually rapid and reaches its peak within 4 weeks in the majority of     patients, but many develop their maximum deficit within 2 weeks. Thereafter, the patients     have a variable prognosis.      GBS is a treatable disorder. Intravenous immunoglobulin (IVIg) 2g/kg administered in 5 days     was shown to be effective when administered within the first two weeks after onset of     symptoms, and is considered the treatment of choice by most experts in the field. Although     the standard treatment for GBS is a single course of IVIg (2g/kg administered in 5 days),     many patients fails to recover abd remain with substantial disability. Patients with GBS and     especially those with a poor prognosis potentially may benefit from more powerful abd when     possible a more mechanistically rational therapy.      Recent experimental evidence suggests that complement activation palys a crucial role in the     development of neuromuscular weakness in GBS making complement inhibitors and regulators     attracive therapeutic targets. Our hypothesis is that Eculizumab, with its function as a     complement inhibitor, will be very effective in preventing progression of weakness in     patients with GBS.   "
96017|NCT02029365|"     In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility     remains  unexplained . Among the causes of female infertility , there are the eating     disorders, as well as sexual disorders , these two cases may be linked. In addition, data     from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding     behavior of infertile women is more often disturbed than the general population. Moreover,     the notions of desire for a child and maternal representations seem essential to address in     the comprehensive care of women with infertility but also TCA integrating all conflicting     issues reactivated at the time of motherhood. However, little work has been done on this     subject. Thus, we propose a study on the desire for children and the eating disorders to     infertile women, to update epidemiological data, but also to better characterize this     particular patient population. Perspectives of this work are to improve screening measures     and support through a joint work of doctors reproductive and psychiatrists.   "
96018|NCT02029352|"     Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in     Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the     Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10%     annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for     men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%).      A simplified classification of BCC includes the following three histological subtypes:     nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs)     differ from the other subtypes as they tend to appear at a younger age, usually occur on the     trunk and are often multiple. This subtype has the fastest growing incidence.      A characteristic feature of BCCs is their low risk to metastasize, though if untreated they     may induce considerable functional and cosmetic morbidity as they are locally invasive.     Surgery is the first treatment of choice for BCC. However due to the rising incidence and the     extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as     they grow down from the epidermis into the superficial dermis and therefore are easily     accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or     5-fluorouracil cream are available topical treatments for sBCC however their tumour free     survival rates are not equal to the higher tumour free survival rates of surgical treatment.     Next to the efficacy, the now available topical treatments are associated with local skin     reactions at the treatment site, mainly erythema and erosion (imiquimod cream and     5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for     additional or alternative non-invasive topical treatments.      The active constituents of green tea are promising as they are supported to have     anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies.     The so-called polyphenols known as catechins are the active constituents of green tea and the     catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is     thought to have a cytotoxic effect on skin cancer cells and has the availability of     inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a     role in inactivation of β-catenin signalling, an important component of the WNT pathway.      Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the     species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins     (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the     US Food and Drug Administration (FDA) for genital warts in adults.      There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial     we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in     humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo     for the topical treatment of sBCCs.   "
96019|NCT02029339|"     The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually     avoided in infected or critical colonized wounds. To our observation, the additional     continuous irrigation tube attached beside the suction tube in the NPWT system could provide     the effective drainage by reducing the occlusion of suction tube, enable effective     debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by     providing relatively moist ambient. At our institutions, the modified system combined with a     triple-tube device to allow a continuous instillation became more active and efficient. The     study is to investigate if a continuous triple-tube instillation and suction could improve     the outcomes of acute severely infected open abdomen.   "
96020|NCT02029326|"     Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by     obtaining a level of sensitivity down to single tumor cells without compromising specificity.     This allows assessment of multiple TKI treatment targets, their activation status, as well as     down stream signaling proteins using very tiny amount of tissue that can be obtained by FNA     or CTCs.      We planned this study to explore biomarkers predictive of clinical response to     cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We     will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor     changes in the RTK activation status during cetuximab treatment using circulating tumor cells     and analyze correlation between the quantity of circulating tumor cells and treatment     response to cetuximab.   "
96021|NCT02029313|"     The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled,     2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic     Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in     Healthy Male Korean Subjects   "
100331|NCT01972880|"     To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a     two-way crossover method in non-elderly healthy male subjects. In addition, the safety of     these products will be assessed.   "
96022|NCT02029300|"     There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In     general, nasal intubation by any conventional method may be the preferred choice for certain     procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth     opening. If nasal intubation is not indicated or preferred, then oral intubation is usually     performed.      This study is looking to explore whether or not the nasal route significantly improves the     ease and time for successful fiberoptic intubation compared to the oral route in children     less than or equal to 2 years of age. This study will also examine if operator experience     influence time to tracheal intubation with either route?      The investigators hypothesize that the nasal route of fiberoptic intubation will be faster     than the oral route, for both the trainee and the expert, and that there will be minimal     differences between experts and trainees with nasal fiberoptic intubation.   "
96026|NCT02029248|"     Anorectal malformations, occurring approximately 1 in 5000 live births, mainly involve the     distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from     the minor and easily treated with an excellent functional prognosis, to those that are     complex and often associated with a poor functional prognosis.      Despite the better knowledge of the anatomy and physiology and the improvement of surgical     management after birth, fecal and urinary incontinence can occur, due mainly to deficient     nerve supply.      The quality of life of such patients is largely unknown in this country. The aim of the     investigators study is to propose specific and generic questionnaires to the patients     registered in the national database, correlated to their anatomical and functional status. A     better understanding of such correlations should allow improvements in their medical and     social management.   "
96027|NCT02029235|"     The purpose of this research study is to find out which combination of pain medications     following surgery work the best and result in the fewest side effects.   "
96028|NCT02029222|"     Patients with lung cancer may develop a second primary tumor or recurrent disease after     previous radiotherapy. Surgical salvage therapy is the mainstay of therapeutic options.     However, in case of irresectable disease, re-irradiation should be considered. Also in the     postoperative setting, re-irradiation is considered after surgical salvage in case of     features in the pathology specimen indicating a high risk for subsequent recurrence. However     after re-irradiation, there is a high risk of 43% grade 3 (late) toxicity at 5 years     (including possible fatal complications) and a relatively low chance of locoregional control     of 50% at 5 years. One out of three patients survives re-irradiation without recurrence and     severe complications. Improvements in both the risk of radiation-induced complications and     the oncological outcome are thus warranted.      Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the     potential to inflict maximum damage on tumors with minimum collateral damage to neighboring     healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than that     of conventional radiotherapy (RT) with photons, it is necessary to establish whether these     higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the     situations in which PT outperforms conventional photon treatment is needed. Publications on     this topic are rare. The only recent publication has analyzed the results of 37 NSCLC     patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy [Kruser     in press].      We propose an in silico trial to investigate to what extend proton and 12C-ion therapy     decrease the amount of irradiated normal tissue in lung cancer patients treated with     radiotherapy after an initial radiotherapy treatment.   "
96029|NCT02029209|"     1. To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in          the phase II study of anlotinib in patients with advanced non-small cell lung cancer.        2. To clarify the meaning of peripheral markers and blood perfusion parameters in vivo          tumor in predicting the effect of anti-angiogenic therapy.   "
96030|NCT02029196|"     Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are     otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems.     These may look like conventional cigarettes but do not contain tobacco.      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or     glycerol), nicotine, water, and flavours.      This trial is to evaluate the safety of an e-vapour product.   "
96031|NCT02029183|"     Ischemic stroke is a kind of common disease with great harm. In acute stage of stroke there     is sharply increasing morbidity of sleep apnea hypopnea syndrome. Our suppose that treatment     with noninvasive ventilation for patients with acute ischemic stroke should improve the     functional prognosis（measuring with 90d modified Rankin score）.   "
96032|NCT02029170|"     Unstable ankle fractures are commonly treated operatively. After operative reduction and     fixation of the fractures, there are varying rehabilitation regimes that include     non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or     brace, or early protected weightbearing in a rigid cast. Several papers reported that early     weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return     to activities. However, early weightbearing may have the risk of displacement of the fixed     fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear.     We hypothesized that the ankle function assessed on 12 months after operation of an ankle     fracture with early weightbearing is not inferior to non-weightbearing but is superior to     non-weightbearing with respect to time to return to normal daily life and time to full     weightbearing.   "
96033|NCT02029157|"     The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with     hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic     chemotherapy regimen including sorafenib.   "
96034|NCT02029144|"     Dydrogesterone has been widely used worldwide for various gynecological and obstetric     indications:        -  Dydrogesterone is effective in cycle regulation treatment.        -  Dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (HPO)          axis in the recommended dosage.        -  Dydrogesterone might have non-negative effect on glucose and lipid metabolic.   "
96035|NCT02029131|"     Evaluation of the effectiveness of an individually educated exercise program for the lower     back at home in employees over a period of 20 weeks.      We hypothesize that regular exercise for the lower back results in greater improvements of     low back strengths compared to controls.   "
96036|NCT02029118|"     Hypothesis: acupoint application is effective for managing chronic stable angina pectoris.     Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints     for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200     participants will be included. Four arms: herbal medicine application on acupoint group ,     placebo application on acupoint group , herbal medicine application on non-acupoint group and     placebo application on non-acupoint group.   "
96037|NCT02029105|"     In this study, the investigators analyzed the efficiencies of hyaluronan, osteopontin,     C-ERC/mesothelin, N-ERC/mesothelin and syndecan-1 serum levels, both individually and in     combination, in distinguishing malignant pleural mesothelioma patients from patients with     metastatic malignant pleural diseases, benign pleural diseases, and benign asbestos pleurisy.   "
96077|NCT02028585|"     This study aimed to investigate the effects of low-fat milk consumption on metabolic     parameters and biomarkers related to inflammation, oxidative stress, and endothelial function     in Korean adults with metabolic syndrome.   "
96038|NCT02029092|"     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to     long-term complications range from rather immediate elastic coil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),     designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis     rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS     substantially reduced the incidence of abrupt artery closure, but restenosis still occurred     in about 20 to 40% of cases, necessitating repeat procedures.      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by     adding an antiproliferative drug (directly immobilized on the stent surface or released from     a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS     with systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease.      Therefore this observational registry has been designed for the clinical evaluation of the     ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the     collection of clinical evidence for the clinical performance and safety of ORSIRO drug     eluting stent system in daily clinical practice.   "
96039|NCT02029079|"     Malnutrition increases the risk of complications and predisposes ti infections through     impaired immune response and wound healing. Healthcare costs related to the management of     malnourished patients is estimated to be more than double the amount spent managing non-     malnourished      The objective of this study is to examine the effect of newly developed energy and     nutrients-dense beverage product on the nutritional status among patients at risk of     malnutrition.   "
96040|NCT02029066|"     This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As     safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body     temperature) will be recorded.   "
96041|NCT02029053|"     This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring     to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is     designed to release glycerol. The study will assess the duration of lubrication/     moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and     participant satisfaction of the device.      Study participants will insert the intravaginal ring and leave it in place for an initial 7     days and then repeat this process a 2nd time. Participants will respond to questionnaires,     complete a daily diary and come in for 4 separate study visits. Each study visit will involve     a brief vaginal exam.      Upon removal of the initially inserted device (7 days after first study visit), participants     will insert a second device for an additional 7 days and undergo the same evaluation.   "
96042|NCT02029040|"     This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department.     The primary objective is to determine whether nebulized 3% hypertonic saline is more     effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency     department.   "
96043|NCT02029027|"     The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator,     during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI     (composed predominantly of stress UI), that responded to physiotherapy were included in this     study in two parallel groups. The groups followed a self-reeducation program, with or without     GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based on the     rate of women for whom the benefit of the initial perineal reeducation was maintained.   "
96044|NCT02029014|"     The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial     appendage closure system in patients with non-valvular atrial fibrillation who cannot be     treated with Warfarin.   "
96045|NCT02029001|"     MOST is a phase II trial conducted in adult patients with an advanced solid tumor in     progression after at least 1 prior treatment regimen. The study aims to assess whether a     12-week treatment with a targeted therapy selected based on the alteration(s) detected in the     tumor is sufficient to stabilize the disease compared with a longer treatment, for all     patients presenting this alteration, regardless of the primary disease site or cancer type.     All the targeted therapies administered in MOST study already obtained a marketing     authorization (MA) but will be evaluated in indications other than those defined in their MA.      Each patient enrolled will receive the matching targeted therapy during 12 weeks (induction     treatment). At the end of this period:        -  patients with a tumor response will continue the targeted therapy,        -  patients in progression will discontinue the targeted therapy and will be withdrawn from          study and oriented towards standard treatments        -  patients with a stable disease at 12 weeks will be randomized in order to determine if          they continue or stop the targeted therapy.      About 80 patients will be treated in each of the 5 treatment groups opened to enrollment,     each group corresponding to an available targeted therapy.   "
96046|NCT02028988|"     This research study is evaluating a drug called enzalutamide in combination with external     beam radiation therapy as a possible treatment for prostate cancer. Presently, when     participants receive hormonal therapy with radiation therapy for prostate cancer, medications     are given to reduce testosterone levels in the blood stream. This leads to side effects such     as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose     of this study is test another form of hormonal therapy with radiation therapy. The medication     called enzalutamide will be used with radiation therapy. Instead of lowering testosterone,     enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used     with radiation will lower the PSA without causing the side effects associated with     medications that lower testosterone in the blood stream.   "
96187|NCT02027142|"     This study included women referred to two academic centres for the diagnosis and treatment of     endometriosis (cases) and women referred to our Institutions because of routine gynaecologic     consultations (controls). In this age-matched case-control study, the aimdy was to assess     quality of sleep, the average daytime sleepiness and insomnia in patients with endometriosis     by using three different self-reported questionnaires.   "
96047|NCT02028975|"     Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is     accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to     determine in healthy humans whether the orosensory perception of fatty acids is followed by a     modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1,     secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue     (leptin, ghrelin, adiponectin).      We also aim to determine whether the hormonal response induced by orosensory stimulation by     lipids is modified:        -  in patients with type 2 diabetes        -  in obese non-diabetic patients We expect to show an increase in biological markers          biological, and more particularly in certain digestive hormones such as Pancreatic          polypeptide, GIP, GLP-1…after stimulation of the lingual lipid receptor, CD36. We will          also determine whether or not this response is modified in patients with type 2 diabetes          and in obese non-diabetic patients.      We also wish to measure the subjects' gustatory detection threshold for a fatty acid     (linoleic acid), and to determine whether there is a relationship between the orosensory     perception threshold for linoleic acid and the physiological status of the subjects. In order     to achieve this, the thresholds for healthy subjects will be compared with thresholds for     obese and diabetic subjects. Expected results: the threshold of detection for linoleic acid     in healthy subjects will be lower than that in obese or diabetic patients.   "
96048|NCT02028962|"     The research aim is the development, implementation and evaluation of the first computer     tailored smoking cessation progam for Romanian adult smokers. It will be implemented among     smokers from Romania aged 20-60 years. The participants will beneficiate of tailored     information received in letters generated by using sophisticated computer algorithms,     allowing the creation of highly individualized messages that address each individual's unique     needs, motivations and beliefs related to smoking .      Program implementation will comprise of :        1. ''diagnosis'' by means of questionnaires at the individual level of characteristics that          are relevant for a person's smoking behavior        2. development of the ''message library'' that contains all education messages that may be          needed        3. development of an ''algorithm'', a set of decision rules that evaluates the diagnosis,          selects and generates messages tailored to the specific needs of the individual user        4. generating of personalized letters for each participant        5. sending of theses personalized letters to the participants. The participants will          receive three personalized letters during a period of six months after registration into          the program.      The effects of the program will be evaluated with a randomized controlled trial which will     assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy     and quiting attempts at 6 months after the enrolment into the program.      A process evaluation will assess participants' opinion about the program.   "
96049|NCT02028949|"     Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor     prognosis as there are no recommended curative treatments. Chemoembolisation is the most     widely used treatment in these patients, but this technique can prove to be toxic.     intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective     therapeutic approach, without deteriorating liver function.      The rationale for this treatment can be resumed as follows:        -  HCC are vascularised via the hepatic artery system        -  The IHA perfusion of anthracyclines leads to high elimination via the liver with low          systemic concentrations        -  The absence of embolisation reduces toxicity        -  the toxiciity profile of idarubicin is well known and the drug is widely used for the IV          treatment of leukemia        -  idarubicin is the most cytotoxic drug for tumor cell lines.        -  The in vitro cytotoxicity of idarubicin is 100% at low concentrations        -  Lipiodol can stay in contact with tumor tissue for several weeks after injection and act          as a vector for the drug        -  The idarubicin-lipiodol is more stable than lipidol emulsions usually given by          intraarterial injection        -  The emulsion is more stable with idarubicin than with other anticancer molecules        -  Sequential inclusion in accordance with the continual reassessment method makes it          possible to increase inclusions at a target toxicity level while reducing inclusions at          doses that are too low or too toxic The aim of the treatment is to improve survival.   "
96050|NCT02028936|"     Many epidemiological and clinical studies have suggested the negative effect of oxidative     stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in     patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.      Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary     supplementation with polyphenols in high-risk patients could diminish the harmful     consequences of oxidative stress.      The aim of this study is to show that the daily consumption of grape juice rich in     polyphenols  R@isol , has a positive impact on the oxidation/antioxidation balance in     healthy volunteers.   "
96051|NCT02028923|"     This phase III study aims to show that topical morphine low doses treats localized pain in     chronic wounds, intense and rebellious to systemic analgesics included or not opioids.   "
96076|NCT02028598|"     The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of     co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the     effects after single oral administration in Korean healthy male volunteers.   "
96078|NCT02028572|"     Glaucoma is an optic neuropathy characterised by progressive degeneration of retinal ganglion     cells and axons that leads to nerve fibre loss, optic disc cupping, and consecutive     glaucomatous visual field defects. It is considered to be one of the major causes of     blindness worldwide.      It is a well accepted fact least 25 - 40% of retinal ganglion cells need to be lost before     statistically detectable visual field defects appear on automated visual field testing, which     is also consistent with post-mortem histologic findings in glaucomatous eyes. Since the     damage associated with glaucoma is irreversible, and retinal nerve fibre layer loss is     considered as an early sign of glaucomatous damage, its early detection and prevention is     warranted. Retinal nerve fibre layer studies can be undertaken through non - invasive,     reproducible technologies such as optical coherence tomography, scanning laser polarimetry     etc.      The purpose of the study is to evaluate the relationship between visual fields and retinal     nerve fibre layer thickness as measured by Cirrus spectral domain optical coherence     tomography with visual fields by Humphrey Field Analyser (HFA) in early and moderate primary     open - angle glaucoma.   "
96079|NCT02028559|"     A feasibility study to test the ability to move kidney stones using a modified ultrasound     system. It is the goal of our technology to move the stone fragments to a location within the     kidney to improve their chances of passage, and thus reduce the occurrence of additional     symptomatic events and retreatment.   "
96052|NCT02028910|"     Acute gastroenteritis is a common disease especially in children. With bronchiolitis and     influenza, she participated widely in weight of winter epidemics that causes problems every     year our health care system, particularly in the pediatric emergency and inpatient since they     are the second leading cause of hospitalization in children. The main symptoms of viral acute     gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes     severe dehydration, the most common cause of hospitalization. There is no specific treatment     for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix     ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment     of acute gastroenteritis virus is symptomatic and is generally based on the use of oral     rehydration solutions (ORS) whose administration is limited by the frequent presence of     vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute     gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are     ineffective in practice, very few studies in this indication and encumbered side effects.     Several drugs have long been used in children to fight against severe vomiting associated     with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and     ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act     both on the enteric nervous system by blocking serotonin receptors. Several     placebo-controlled trials suggest that ondansetron is effective in reducing the number of     vomiting in children emergency consultant for acute gastroenteritis. However, the method used     in these tests and the number of children enrolled has not yet demonstrated the efficacy of     ondansetron on the number of admissions, the number of emergency and return the cost /     benefit ratio of this treatment. In addition, several studies reported the occurrence of     watery stools more frequently in children treated with the placebo group.      Evidence that ondansetron is well tolerated and effective for reducing the severity of     vomiting during acute gastroenteritis pediatrics winter could support the use of this     treatment in routine pediatric emergencies.      This study is a clinical trial, multicenter, controlled versus placebo whose main objective     is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children     with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after     signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria     for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron     (active) or placebo. The study does not alter the usual care of the child to the emergency     room. After passing emergency, patients will be followed in the study for 8 days, through a     phone call home to J3 and J7. The total duration of patient participation in the study is 8     days, including 4 hours emergencies (usual transit time to emergencies).   "
96053|NCT02028897|"     This study will compare two alternative embryo culture systems. Embryos from each patient     will be randomly assigned to one of two systems. One group will be cultured conventionally in     oil-covered droplets in dishes. The other group will be assigned to an enclosed system.   "
96054|NCT02028884|"     The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,     pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD   "
96055|NCT02028871|"     This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in     reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.   "
96056|NCT02028858|"     This is a prospective, observational study designed to describe the effects of Cannabis on     Parkinson's Disease tremor.   "
96057|NCT02028845|"     1. Background             -  Advanced guidewires with a U-shaped tip could effectively cross the long or               multi-occlusive segment smoothly and go into the distal outflow vessel.             -  The guidewire looping technique is a safe and effective method for the               recanalization of the occluded lesions in infrapopliteal vessels.        2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped          guidewire in achieving successful deep biliary cannulation.        3. Design           - Prospective randomized trial.        4. Setting:           - Tertiary-care medical center        5. Patients           - This study will involve 192 patients with biliary diseases which require endoscopic          retrograde cholangiopancreatography.        6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a          straight-tipped guidewire        7. Main outcome measurements - Compare the cannulation success rate, the duration of the          cannulation, immediate and late complications.   "
96058|NCT02028832|"     This study will investigate if adding complementary therapies such as acupuncture, massage     and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such     as patient symptoms, cost, safety, satisfaction and length of stay.   "
96059|NCT02028819|"     Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human     T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+     lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and     HIV-infected individuals showing safety and efficacy for suppressing HIV replication.   "
96060|NCT02028806|"     This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as     first-line treatment for metastatic pancreatic cancer in China.   "
96061|NCT02028793|"     National Health Insurance Administration, Taiwan has provided a protocol for community     pharmacist to offer home pharmaceutical care for the patients with high health expenditures.     Since community pharmacists need to visit patients for consultation and check their     medications, it has been thought to have pressure for them in various areas. This study     intends to investigate the factors related to the pressure and intention for leaving this     protocol. The hypothesis are that community pharmacist who works longer, has economic     pressure, and longer year of practice will have higher pressure and strong intention for     leaving.   "
96062|NCT02028780|"     The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI     655075 following intravenous administration of single rising doses of BI 655075 when     administered alone and after administration of dabigatran.   "
96120|NCT02028013|"     Bioresonance is the big promise of the medical technology of the future because it stimulates     the self-regenerating system of the body by affecting the body`s most essential procedures.     The big advantage is that its multiple and there are no harmful side effects. This therapy     teaches something to the body what in a younger and healthier state it had already     Bioresonance is based on the scientific principle that metabolism within cells is influenced     by one's electromagnetic field.      We start to use bioresonance technology in management of erectile dysfunction , premature     ejaculation, decreased libido.   "
96066|NCT02028728|"     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to     long-term complications range from rather immediate elastic coil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),     designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis     rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS     substantially reduced the incidence of abrupt artery closure, but restenosis still occurred     in about 20 to 40% of cases, necessitating repeat procedures.      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by     adding an antiproliferative drug (directly immobilized on the stent surface or released from     a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS     with systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease.      Therefore this observational registry has been designed for the clinical evaluation of the     ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the     collection of clinical evidence for the clinical performance and   "
96067|NCT02028715|"     The investigators' goal in this planned prospective, randomized, patient blinded study is to     compare our standard of care as the control group to an experimental group in which patients     receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8     doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will     include amount of rescue opioids required, time to return of bowel function, length of     hospital stay, cost effectiveness, and patient satisfaction. The hypothesis is that the     addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease     the incidence of associated gastrointestinal side effects including nausea, vomiting,     bloating, and constipation. The hope is that it will affect the final outcome of quicker     return of bowel function, increased patient satisfaction, shortened hospital stay and prove     to be an overall more cost effective postoperative pain management approach.   "
96068|NCT02028702|"     To investigate the reported health benefits (lipid profile, inflammatory factors,     cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment     on women suffering from both menopause related primary (hot flushes, night sweats, sleep     disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid     metabolism) symptoms.   "
96069|NCT02028689|"     This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of     metformin and furosemide in healthy, adult male subjects.   "
96070|NCT02028676|"     The two original objectives were to determine in HIV-infected children initiating     antiretroviral therapy (ART):        1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of          disease progression or death as routine laboratory and clinical monitoring (LCM) for          toxicity (haematology/biochemistry) and efficacy (CD4)?        2. Whether induction with four drugs from two ART classes followed by maintenance with          three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse          transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical          outcome?           Two secondary objectives were to determine        3. Whether changing from twice daily lamivudine+abacavir to once daily lamivudine+abacavir          after 48 weeks on ART will have a similar outcome in terms of virological suppression          and will result in improvements in adherence to ART?        4. Whether stopping daily cotrimoxazole prophylaxis in children over 3 years of age who          have been on ART for at least 96 weeks has a similar outcome in terms of hospitalisation          or death as continuing daily cotrimoxazole?   "
96071|NCT02028663|"     The purpose of this study is to investigate the optimal dose and administration methods of     CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally     administered CJ-12420 to esomeprazole 40mg.   "
96072|NCT02028650|"     The relapse leukemia patients after transplantation were divided into two groups randomly.     Group D1: patients received first-donor stem cells infusion(DSI) treatment with or without     chemotherapy; group D2: patients received second-donor DSI treatment with or without     chemotherapy. The second donors were preferably donors who were genetically related and had     more HLA-match locus. The re-induction chemotherapy regimen was primarily MAT(mitoxantrone,     cytarabine, Teniposide ) for acute myeloid leukemia (AML) and VMCLD(vincristine, Teniposide,     cyclophosphamide, L-Asparaginase, Dexamethasone) for acute lymphocytic leukemia (ALL), and no     graft versus host disease(GVHD) prevention was conducted pre- and post- therapy.   "
96073|NCT02028637|"     Introduction: Recently it has involved the role of TLR (toll-like receptors) in the     pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of     Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in     IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could     open new therapeutic expectations.      Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and neutrophils     in peripheral blood and induced sputum from asthmatic patients   "
96074|NCT02028624|"     Aim of the present study was to evaluate the effect of different lifestyle intervention     administrations, in increasing adherence to the Mediterranean diet in a group of patients     with RA living in the Mediterranean basin, and, thus, in improving parameters related to     subjective and objective disease markers, including plasma adiponectin concentrations.   "
96082|NCT02028507|"     This is an international (5 countries) randomized phase III study with 2 cohorts, patients     will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2:     fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125     mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3     weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous NSAI     (letrozole or anastrozole) defined as: recurrence while on or within 12 months after the end     of adjuvant treatment or progression while on or within 1 month after the end of treatment     for MBC. Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or as     first line for MBC. Patients must have measurable disease according to RECIST 1.1 or bone     lesions, lytic or mixed, in the absence of measurable disease.   "
96083|NCT02028494|"     The purpose of this study is to compare the efficacy of a novel schedule of an oral     anticancer drug, capecitabine, in patients with metastatic breast cancer.      Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is     an optimal dosing schedule for this drug and previous studies done al Memorial Sloan     Kettering Cancer Center support the tolerability of this scheme.      This definitive, randomized trial comparing the efficacy of the new dosage with the     conventional dosing schedule in patients with metastatic breast cancer is necessary and we     hypothesize it will be superior in terms of efficacy.      Dosing schedules based on mathematical predictions for optimal drug delivery based on     efficacy rather than toxicity could facilitate more rapid and economical drug development.     This trial is a proof of principle trial of the highest priority.   "
96084|NCT02028481|"     Macular hole is a hole formation which takes place in the center of the retina. Such a hole     needs surgical steps in order to close. Closure of the macular hole will lead to a     substantially improvement of vision in most cases. Following macular hole surgery a tamponade     of intraocular gas is normally injected in order to keep the macula dry for the postoperative     period. Postoperative face down position for a week was earlier standard. Several authors     report of good closure rates with both air tamponade or lack of face down positioning. In     this study standard pars plana vitrectomy with peeling of the internal limiting membrane     (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down     positioning will not be used. Only macular holes less than 400 μm will be included.   "
96085|NCT02028468|"     Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly.     During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been     increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a     MIS approach.   "
96086|NCT02028455|"     Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For     this reason, we are attempting to use T cells obtained directly from the patient, which can     be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T     cell to recognize and kill the leukemic cell through the recognition of CD19, a protein     expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a     phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well     as to determine the efficacy. The phase 1 cohort is restricted to those patients who have     already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all     patients regardless of having a history of HCT.   "
96087|NCT02028442|"     This is a multicentre, open-label, Phase I/II study of enadenotucirev in patients with either     solid tumour of epithelial origin not responding to standard therapy or for whom no standard     treatment exists (Phase I dose escalation stage Single cycle), mCRC not responding to     standard therapy (Phase I dose escalation Repeat cycle cohort expansion stage ), mCRC not     responding to standard therapy or advanced or metastatic bladder cancer not candidate for     chemotherapy (Phase Ib) or mCRC in stable disease or partial response after 3-4 months of     first line standard of care chemotherapy (Phase II).   "
96088|NCT02028429|"     The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase     inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal     hepatic encephalopathy (MHE) as proposed in different studies.      This study would also assess the role of improvement of cognition as a means of improvement     in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks.      This study may prove and provide important therapeutic strategy for cognition impairment in     patients with MHE.   "
96089|NCT02028416|"     Acquired Aplastic anemia is one of the most frequent reason of bone marrow failure in East     (Pakistan).        -  The first treatment option is Allogenic Bone Marrow transplantation which is an          expansive treatment option and also require a full matched HLA identical donor, hence          hardly 25% of our affected patients get opportunity for BMT.        -  The second line treatment option caters a large chunk of patients (severe and non-severe          AA) along with those who lack HLA identical donor.      Previously many protocols had been used in past for ATG+CsA Treatment, this treatment     protocol especially addresses the two different regimens of ATG to study its efficacy,     durability and long-term effects. Following doses would be used:        -  CsA+ATG @ 10mg/kg for 3 days        -  CsA+ATG @ 10mg/kg for 5 days   "
96090|NCT02028403|"     People infected with HIV may have low levels of the virus in their body, even if they are     taking HIV medications. This study will evaluate the safety, pharmacokinetics (PK) (which is     how the body interacts with drugs), and immune response to BMS-936559, a drug that will be     administered by an intravenous (IV) infusion, in HIV-infected people receiving combination     antiretroviral therapy (cART) who have viral load levels below the limit of detection.   "
96091|NCT02028390|"     The purpose of this study is to test and evaluate how well a medical imaging device that     takes both visual and thermal pictures of wounds or body surface areas of interest can help     collect added information about the wounds or body surface areas of interest in a wound     clinic.   "
96092|NCT02028377|"     This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify     hidden metastatic disease or identify patients with borderline or locally advanced disease.   "
96210|NCT02026843|"     This study was conducted to investigate the levels of angiogenic factors and anti-angiogenic     factors in the aqueous humor of patients with diabetic retinopathy.   "
96211|NCT02026830|"     To determine the causative microorganisms and their antibiotic sensitivity patterns in     diabetic patients with a foot infection in Turkey.   "
96093|NCT02028364|"     This is a prospective, single arm trial in which patients with locally advanced or metastatic     endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal     aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction     with exemestane 25mg orally daily until disease progression or treatment discontinuation for     any other reasons. Tumour, metastatic lesions and blood samples will be collected during the     treatment period. Genomic analysis on metastatic tumour tissue specimens and liquid     biopsies will help to identify patients who benefit of this treatment regimen. The main     objective is to evaluate if early metabolic response (MR) using FDG-PET/CT is associated with     progression free survival (PFS) this population.   "
96094|NCT02028351|"     Purpose of The Study:      The purpose of this study is the following:      A)To gather age-related normative visual acuity data for the Vimetrics Central Vision     Analyzer (CVA, Vimetrics, LLC, Media, Pa) B)To gather visual acuity data for patients with     known ocular problems, including cataract and maculopathy.      C)To correlate and compare the CVA visual acuity findings with the acuity measured with     standard LogMAR acuity charts viewed under similar conditions of contrast and lighting   "
96095|NCT02028338|"     To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in     HIV-uninfected adolescent females, when inserted once every 4 weeks during 12 weeks of study     product use   "
96096|NCT02028325|"     The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and     the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.   "
96097|NCT02028312|"     A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel     0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in     subjects with dry eye.   "
96098|NCT02028299|"     An echocardiogram using Definity contrast can provide the same information as the standard     right heart catheterization.   "
96099|NCT02028286|"     The purpose of this study is to characterize the pharmacokinetics of once daily topical gel     and confirm that steady state conditions are reached under maximal use conditions following 3     weeks of daily applications.   "
96100|NCT02028273|"     This study is being done to measure the number of brain cells that grow in the brain     throughout our lives while determining an effective way to complete this with an MRI     (Magnetic Resonance Imaging) scanner. The number of these brain cells may be affected by     cocaine use. Researchers are trying to understand the long-term effects of cocaine use on the     brain.   "
96101|NCT02028260|"     This is a randomized, double-blind, placebo controlled study of 30 patients. Patients who     qualify, as per the inclusion criteria (RASS greater than -3, less then +1, CAM positive,     present gastric access) will either be given 200mg of modafinil or an identical,     indistinguishable placebo. The placebo and study drug will be distributed by the hospital     pharmacy. Once enrolled, each patient will be reassessed every morning to determine     appropriateness for drug administration. If the RASS is less than -3 (i.e. comatose) or     greater then 0 modafinil will not be given. He/she will then be assessed each morning     thereafter. Due to the stimulant-like actions of modafinil, the drug will be administered     only in the morning. Patients will be assessed for delirium at least twice a day; trained     personnel using the Confusion Assessment Method (CAM) will do the assessment. Qualification     for a delirium free day will be no positive CAM screens for 24 hours following drug     administration. Additional data such as days on mechanical ventilation and progression to     tracheotomy will also be collected hypothesizing that patients who take modafinil will have a     shorter time to extubation therefore avoiding the need for a tracheotomy. Post-discharge from     the unit, but within 48 hours, patients will be asked to participate in a survey (The     Richards-Campbell Sleep Questionnaire (RCSQ) assessing their perception of daytime and     nighttime sleepiness in the intensive care unit as well as their overall perception of rest.     Their functional capacity will also be evaluated at this time and compared to their     pre-morbid baseline. The hypothesis tested is that Modafinil restores sleep cycle synchrony     in the ICU therefore increasing delirium free days and improving ICU outcomes.   "
96102|NCT02028247|"     Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD),     contributing to substantial distress and impairment. The goal of this study is to examine the     effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for     addressing anxiety in youth with ASD.   "
96103|NCT02028234|"     Clopidogrel and Prasugrel are pro-drug necessitating conversion in active metabolites through     CYP 450 system (CYP), particularly CYP3A and CYP2C19 isoforms.      These drugs are platelet purinergic receptor antagonists, known as P2Y12. The link between     active metabolite of Clopidogrel and Prasugrel to P2Y12 receptor prevents ADP receptor     activation and inhibits several events leading to conformational change of platelets,     therefore facilitating their activation and aggregation, that is the basis of acute coronary     syndromes. Proton pump inhibitors (PPI) are actually considered principal agents reducing     gastroenteric bleeding risk associated to antiplatelet therapy. Nevertheless the interaction     between PPI and antiplatelet therapy has been object of interest. Several studies     demonstrated PPI reduce efficacy of clopidogrel on platelet reactivity. Only few data about     Prasugrel are available showing a minor effect of PPI on its antiplatelet activity than     clopidogrel. Differing from prasugrel and clopidogrel, ticagrelor is a direct inhibitor of     P2Y12, not necessitating biotransformation in the liver; therefore its interaction with PPI     remains unclear. Interaction between omeprazole and clopidogrel seems related to high     inhibitory activity of PPI on CYP2C19, interfering with the conversion of clopidogrel in its     active metabolite.   "
96117|NCT02028052|"     The objective of this study is comparing the attributable procedural time of Endobronchial     Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar     lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the     time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes     will include total number of sampled lymph nodes, average number of needle aspirations per     lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.   "
96118|NCT02028039|"     The goal of this clinical research study is to learn if IPI-145 can help to control the     disease in patients with ALL. The safety of the study drug will also be studied.   "
96212|NCT02026817|"     To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and     co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.   "
96104|NCT02028221|"     Overweight and obesity are well established risk factors for breast cancer that develop after     menopause. The increased postmenopausal breast cancer risk in women who are overweight or     obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly     used medication in diabetics to stabilize blood sugar. Association studies and laboratory     studies have shown its potential to reduce the risk for development of cancer, including     breast cancer. Recent pilot clinical studies in breast cancer patients suggest that metformin     may only be effective in overweight or obese women with metabolic disturbances. We propose to     conduct a clinical study of metformin in overweight or obese premenopausal women with     metabolic disturbances. Study participants will be randomly assigned to receive metformin or     placebo for 12 months. The study will evaluate whether metformin can result in favorable     changes in risk features that have been associated with increased breast cancer risk. The     risk features that will be examined in our study include breast density, certain proteins and     hormones, products of body metabolism, and body weight and composition. The study should help     determine the potential breast cancer preventive activity of metformin in a growing     population at risk for multiple diseases.   "
96105|NCT02028208|"     The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test     allergens to the marketed petrolatum reference allergen.   "
96106|NCT02028195|"     Check your health is a prevention intervention designed to create awareness and action on     health condition with focus at physical activity at a population-level to 30-49 years of age.     It consists of a behavioural and clinical examination followed by either (I) referral to a     health promoting consultation in general practice (II) targeted behavioural programmes at the     local Health Centre or (III ) no need for follow-up; stratified after risk-profile. The CORE     trial (Check your health) aim to investigate effectiveness on health and social outcomes of     the preventive health check and to establish the cost-effectiveness according to life years     gained; direct costs and total health costs. A pragmatic cluster randomised controlled trial     has been established to meet the aims and in total 10.600 individuals from 35 practices have     been randomized in to two groups that will be invited in 2013-14 and 2017-18 respectively.     The group offered the preventive health check in 2013-14 will constitute the intervention     group and the group examined in 2017 - 18 the control group. A follow up of the intervention     group in 2017 - 18 will provide data for the intention to treat analysis revealing the     effect. Outcome measures are level of physical activity, risk of getting cardiovascular     disease, sick leave and labor market attachment.   "
96107|NCT02028182|"     The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test     allergens to the marketed petrolatum reference allergen.   "
96108|NCT02028169|"     This post marketing observational study is designed to provide the initial data on work     impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and     clinical response during treatment with anti-TNF agents.   "
96109|NCT02028156|"     This is a non-randomized, single-group, multi-center, two phased study to evaluate formula     intolerance.   "
96110|NCT02028143|"     Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of     Radiofrequency Ablation of Atrial Fibrillation   "
96111|NCT02028130|"     Atrial fibrillation (AF) affects as many as 1 in 16 people over the age of 65 and reduces the     quality of life of large numbers of people in the UK and around the world. Catheter ablation     is a minimally invasive treatment that has been developed to help eliminate AF. Recent     studies have identified that a particular area of the heart, namely the left atrial appendage     (LAA), which is a pouch in the left atrium (small collecting chamber of the heart), may be     the main source of AF in many cases. There is a clear lack of knowledge about the structure,     anatomy, function and electrical properties of the LAA, which is fundamental to furthering     our understanding and management of AF.      In addition, it is well known that AF significantly increases the risk of stroke. The     majority of strokes occur due to blood clots forming in the LAA. Traditionally, the most     effective treatment to minimise the risk of stroke has been to thin the blood with agents     such as warfarin. This therapy requires regular blood tests at much inconvenience to patients     and increases the risk of bleeding complications. Recently, a large study demonstrated that     use of an implanted device (Watchman®) to occlude the LAA is as effective as warfarin in     preventing stroke and confers a lower mortality rate.      We aim to investigate whether it is safe and feasible to ablate the LAA and to implant a     Watchman® device during the same procedure in patients who are in atrial fibrillation all of     the time.   "
96112|NCT02028117|"     This study is a phase I/II open label clinical study in patients with platinum-resistant     epithelial ovarian cancer. The Phase I part of the study will determine the dose of     enadenotucirev to be recommended for further studies and will examine primarily the safety     and tolerability but also the pharmacokinetics of administering enadenotucirev     intraperitoneally. Once the dose of IP enadenotucirev to be used in combination with IV     weekly paclitaxel has been determined, the phase II stage will begin as an open label dose     expansion of that regimen. The phase II stage aims to determine whether intraperitoneal     enadenotucirev has a risk benefit profile that supports further investigation in the     treatment of patients with platinum-resistant epithelial ovarian Cancer.   "
96113|NCT02028104|"     The purpose of this study was to study the effect of stem cell therapy on common symptoms in     patients with Traumatic Brain Injury   "
96114|NCT02028091|"     Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial hypertension     theoretically changes pulse wave velocity.   "
96115|NCT02028078|"     Primary objective is to investigate the feasibility and stability of determining the     endogenous glucose production during a hypoglycaemic clamp in type 1 diabetes mellitus     subjects by a stable tracer to tracee ratio with an enrichment of 4% and a variation below     +/-30%.      Population: twenty type 1 diabetic subjects      Study design: Single-center, open, non- randomized, pilot-study   "
96116|NCT02028065|"     The purpose of this study is to assess the potential for hypersensitivity symptoms upon     repeat exposure to sugammadex. Healthy participants will be randomized to one of three     treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will receive     3 single intravenous (IV) doses of their randomized treatment, with an approximately 5-week     washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be     confined at the study center from the day before each dose until completion of the 24-hour     post dose assessments.   "
96121|NCT02028000|"     The study is looking at women undergoing cesarean section delivery of their baby. The purpose     of this research study is to determine what type of skin closure after cesarean section helps     decrease pain level the most and improves the appearance of the incision site.      The study hypothesis is to determine if skin closure with absorbable subcuticular staples     leads to improved cosmesis and/or decreased post-operative pain.      Participants in the study will already be scheduled for a cesarean section for delivery of     their baby. They will be randomized into one of three groups, 1) Insorb (absorbable     subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their     cesarean section. Information that will be recorded includes amount of pain medication usage     while in the hospital after cesarean section, daily patient rated pain score until discharge     from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks     after surgery.   "
96122|NCT02027987|"     1. Background:           Preliminary studies have suggested that valproate acid (VPA) may promote neuron          survival, inhibit apoptosis, decrease the neuron function deficit in cerebral ischemia,          and promote the brain functional recovery after traumatic brain injury (TBI). Besides,          in the guide of prevention and treatment of epilepsy in 2007, VPA was one of the          antiepileptic drugs which were suggested to prevent early epilepsy after TBI (less than          7 days).        2. Objectives:           Our main objective was to evaluate whether VPA could protect brain and improve recovery          of brain function after severe TBI. The secondary objective was to explore whether VPA          could prevent late epilepsy after severe TBI (more than 7 days).        3. Methods:      We would enroll 160 patients who were in a vegetative or minimally conscious state 4 to 16     weeks after TBI and who were receiving inpatient rehabilitation. Patients were randomly     assigned to receive VPA or placebo for 4 weeks and were followed for 2 weeks after the     treatment was discontinued. The rate of functional recovery on the Disability Rating Scale     (DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over the     4 weeks of treatment (primary outcome) and during the 2-week washout period with the use of     mixed-effects regression models.   "
96123|NCT02027974|"     The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for     total hip replacement surgery.   "
96124|NCT02027961|"     The purpose of this study is to determine the maximum tolerated dose and the safety profile     of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in     subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type     BRAF, respectively.   "
96125|NCT02027948|"     Patients with esophageal and gastroesophageal junction (GEJ) cancer often have weight loss,     swallowing problems, and poor appetite. This may affect their ability to tolerate cancer     treatment.      The purpose of this study is to see if the researchers can apply a set of nutrition     guidelines designed specifically for patients with cancer who are older than 65 years of age.     The questions will allow them to assess the nutritional status and make appropriate     referrals. If the patients are having swallowing problems or losing weight, the researchers     want to address the nutritional problems early in the course of their treatment.   "
96126|NCT02027935|"     The goal of this clinical research study is to learn about the safety of giving CD8+T cells     with ipilimumab, cyclophosphamide, and IL-2 (aldesleukin). Researchers also want to learn if     this combination can help to control metastatic melanoma (melanoma that has spread).      This study is divided into 2 parts: leukapheresis and treatment. In the leukapheresis part,     blood cells will be collected from you to be made into modified CD8+T cells and given back to     you in the treatment part.      CD8+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,     and they are designed to find melanoma cancer cells and may kill them.      Ipilimumab and aldesleukin are designed to increase the immune system's ability to fight     cancer.      Cyclophosphamide will be used at a very low dose to weaken the body's natural defense against     the T-cell transplant, so that the transplanted T-cells have a chance to grow and multiply.   "
96127|NCT02027922|"     The study is to compare the prophylactic and therapeutic clinical effectiveness of two     fluoride varnishes in children at high caries risk.      It was hypothesized, the use of Fluor Protector S (I) fluoride varnish in children with     deciduous teeth at high risk of caries (P) reduces caries and the activity/remineralisation     of carious enamel spots (transformation of White Spot Lesion into D (decay)) (O), similarly     to what occurs after the use of Duraphat varnish (C).   "
96128|NCT02027909|"     Providing ideal rate response to patients should improve their quality of life and ability to     execute activities of daily living.      Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to     specify an activities of daily living (ADL) response rate and an exertion response rate.     There is much data to support the target heart rate for an exercise response but the data to     support the programming of the ADL rate is lacking.   "
96129|NCT02027896|"     HIP ATTACK is an international randomized controlled trial of 1200 patients with a hip     fracture that requires a surgical intervention. This trial will determine the effect of     accelerated medical clearance and accelerated surgery compared to standard care on the 30-day     risk of a major perioperative complication (i.e., a composite of mortality, nonfatal     myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis,     nonfatal stroke, and nonfatal life-threatening and major bleeding).   "
96130|NCT02027883|"     As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing     implant time is critical. Also, patients receiving biventricular ICDs are sometimes more     unstable and minimization of sedation time is crucial. Multiple induction attempts, with a     1-Joule shock, can cause disruption in lead position. Therefore limiting the number of     attempts will allow for better lead stability throughout the procedure and a more     straightforward implant process.      Investigator proposes a detailed documentation of success rates from various Ventriculart     Fibrillation induction methods during implant of Medtronic defibrillation capable devices.   "
96131|NCT02027870|"     The study aims to further assess the safety, efficacy and the performance of its delivery     system of the new generation Sirolimus-eluting stent of JWMS up to five years.   "
96213|NCT02026804|"     The purpose of this study is to find the incidence of mental disorders during different     periods of pregnancy and its associated factors and consequences.   "
96214|NCT02026791|"     Since the laryngeal mask airway (LMA) was designed and introduced into a clinical setting, a     supraglottic airway device is widely used because it has advantages such as manipulation of     the device when inserting it is easier than that of an endotracheal tube and it causes less     postoperative sore throats. Insertion of an LMA can be performed relatively easily and safety     at an appropriate depth of anesthesia when compared with the insertion of an endotracheal     tube because an LMA is inserted without using a laryngoscope and without causing stimulus to     the vocal cords and the trachea. Hence, an LMA may be useful in cases of coronary artery     disease and a carotid endarectomy where stabilization of the cardiopulmonary function is     important. In addition, an LMA is hemodynamically stable not only in the induction of     anesthesia but also in the arousal of anesthesia and thus less dangerous to a cardiovascular     disease patient. LMA may be useful also to patients having chronic obstructive lung disease     because the patients have an excessively sensitive airway and ventilation is difficult to     perform in them. Therefore, in elderly patients having a prevalence for cardiovascular     disease or chronic obstructive lung disease, use of an LMA, which stimulates the airway less,     may provide hemodynamical stability and reduce relevant complications or side effects. LMA     Supreme which is newly designed in such ways has been proven to be superior to the     conventional LMA Classic in terms of easy insertion and oropharyngeal sealing. A study which     compared LMA Classic and LMA Supreme with adult subjects showed that LMA Supreme had a     superior insertion success rate and better oropharyngeal leak pressure (OLP) than those of     LMA Classic. Another newly developed supraglottic airway device is I-gel. In I-gel, which is     a disposable, latex-free LMA, a soft, gel-type cuff made of a thermoplastic elastomer     replaces the inflatable cuff of other LMAs. Thus, I-gel has an advantage that, once it is     installed, it requires no additional clinical manipulation such as cuff inflation or cuff     pressure monitoring. A comparison of I-gel with LMA Classic and other disposable supraglottic     airway devices produced by various manufactures in adult subjects showed that the clinical     properties were similar with respect to easy insertion, time required for installation,     laryngopharynx leak pressure, and degree of glottis exposure observed with a fiberoptic     bronchoscope. Thus, I-gel is expected to be a supraglottic airway device which may replace     the conventional LMA Classic. The elderly are known to have an upper airway anatomically     different from that of younger adults depending on age. A study conducted with CT showed that     normal elderly people had a wider upper airway than that of younger males or middle-aged     males and that elderly with accompanying sleep apnea had a wider upper airway than that of     younger males in all regions including the nasopharynx, oropharynx, and hypopharynx.     Therefore, because the upper airway of the elderly is wider and longer, a different     supraglottic airway device guide may be necessary. Our previous studies showed that the     single time success rate was significantly lower, the insertion was more difficult, and the     insertion took a longer time when the LMA classic was used in elderly patients than in     younger adult patients. However, there is no available guide for the use of a supraglottic     airway device or for a supraglottic airway device more appropriate for elderly patients.     Moreover, no study has been ever conducted with regard to such a guide.      Therefore, in this study, the clinical usefulness of I-gel and LMA Supreme, which are the     newest supraglottic airway devices, was verified in elderly patients. It was also verified     which of the two devices is better to use as a supraglottic airway device.   "
96132|NCT02027857|"     Brain edema is the main reason for the disability and lethality in traumatic brain injury,     which is the most difficult part of emergency rescue. Recently, there is no medical equipment     to monitor the early brain edema in clinic. We have found that Electrical impedance     tomography (EIT) can perform the real-time and bedside monitoring of brain electrical     impedance after single-dose mannitol treatment, which may be a new strategy for the     surveillance of brain edema. In this study, we would like to compare the application in     traumatic brain edema between EIT and Noninvasive intracranial pressure (ICP) monitoring,     including the progress of brain edema, the relationship between impedance and ICP, and the     improvement for the patients' prognosis. EIT would probably be a new image strategy for the     treatment of traumatic brain injury.   "
96133|NCT02027844|"     Nearly 50% of young children undergoing surgery exhibit high level of anxiety during     induction of anesthesia because of exposure to unfamiliar environment and people and     separation from parents. Increased preoperative anxiety may impact postoperative behavior     changes such as emergence agitation, separation anxiety and sleep disturbance. Although some     pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during     induction of anesthesia, previous studies have reported conflicting results. Recently the     distraction using video game or animated cartoon has been reported to reduce anxiety of young     children during induction of anesthesia. However, it was still undetermined whether     distraction has its own ability to reduce children's anxiety separated from parental presence     because they evaluated the effect of video method in the parental presence. The investigators     design to investigated the efficacy of distraction with watching cartoon, parental presence     and combined with watching cartoon and parental presence on reduction of anxiety during     inhalational induction of anesthesia using sevoflurane. In addition this study includes     long-term effect of each intervention such as postoperative emergence agitation and     postoperative behavior change in children.   "
96134|NCT02027831|"     The purpose of this study is to determine if NIR fluorescent imaging is an effective approach     to detect the margins of head and neck tumours or lymph nodes draining the tumour   "
96135|NCT02027818|"     We will observe if ICG fluorescence correlates with margins of breast tumours after iv     injection of the contrast agent   "
96136|NCT02027805|"     In this study, a combination of two antibodies both conjugated to a cell-killing toxin     (so-called immunotoxins) will be evaluated. The antibodies are directed against T-cell     antigens 'cluster of differentiation 3 antigen' (CD3) and CD7. Previous in vitro studies have     demonstrated that this particular immunotoxin-combination, named T-Guard, acts     synergistically in eliminating T cells with a preference for killing activated T-cells. In a     subsequent clinical pilot-study, T-Guard has generated encouraging results when applied as     third-line therapy for patients suffering form steroid-resistant acute Graft-versus-Host     Disease (GVHD). Extensive biological and clinical responses could be noted in the absence of     severe acute toxicities. Building on these results, the current study aims at evaluating the     safety and efficacy of T-Guard for treating steroid-resistant GVHD when administered in an     earlier phase of the disease process, i.e. as second-line instead of as third-line therapy.   "
96137|NCT02027792|"     This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms     in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be     randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel     daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire     on pain, disability, quality of life and pressure pain sensitivity.   "
96138|NCT02027779|"     This study primarily will address the safety and secondarily will assess efficacy of     GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a     GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).   "
96139|NCT02027766|"     Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and     to prevent sports injuries. It is not known if stretching affects pain sensitivity. The     purpose of this study is to investigate if a 4 week daily stretching protocol alters pain     sensitivity.      The investigators hypothesize that stretching reduces pain sensitivity.   "
96140|NCT02027753|"     Primary Objective:      To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin     glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea      Secondary Objectives:        1. To assess the efficacy by adding insulin glargine        2. To assess insulin dose        3. Safety   "
96141|NCT02027740|"     This prospective cohort study of an almond-enriched diet (within the overall context of Asian     Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM     almond-enriched balanced diet improves glycemic measures and CVD risk factors.   "
96142|NCT02027727|"     The purpose of this study is to determine which early infliximab pharmacokinetic level is     most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.   "
96143|NCT02027714|"     The purpose of this study is to gather information needed to develop a large prevention trial     to decrease the risk for HIV transmission among HIV-discordant couples (where one person is     HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would like to learn     more about men, women and couples in Lesotho and what they think about various topics related     to HIV, including HIV testing and counseling, male circumcision and HIV treatment.      There will be three parts to the study including 1) a survey 2) focus group discussions; and     3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited     to participate in the survey. Women who answer the questionnaire will also be asked to     participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be     conducted. Thirty men from the community will be recruited to participate in an in-depth     individual interview.   "
96154|NCT02027571|"     The reasons for the epidemics of diabetes and prediabetes, and why individuals from certain     populations suffer at higher rates are not well known. In the Pathobiology and Reversibility     of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and     Caucasians whose parents have type 2 diabetes will undergo repeated testing to determine what     factors lead to the occurrence of prediabetes, and whether race still plays a major role in a     setting where everyone being studied has one or both parents with diabetes. The PROP-ABC     Study also will test the hypothesis that the ability of intensive lifestyle intervention to     reverse prediabetes and return people's metabolism back to normal is dependent on how long     people have had prediabetes.   "
96144|NCT02027701|"     This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose     of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with     regard to safety and efficacy.      Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a     CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will     have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for     up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose     IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment.     Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed     a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP     relapse within 4 weeks, they will be withdrawn.      The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).   "
96145|NCT02027688|"     Preterm infants face many feeding challenges during hospitalization which can prolong     hospitalization, raise parental anxiety and can lead to medical instability. The Feeding     Progression study will randomize preterm infants to one of two currently accepted oral     feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect     data on oral feeding success, milk transfer, sucking strength, growth and medical     complications.   "
96146|NCT02027675|"     In a society where exercise is prescribed by physicians to increase physical condition,     improve dietary habits and reduce cardiovascular risk, the impact of exercise, acute or     chronic, and diet in inflammation and immunity is unknown. Specific populations can have     different responses towards acute and chronic exercise. Moreover specific conditions, like     the type of meal ingested, can interfere with these responses. The true effect of     pre-competitive meal exercise in the immunity and inflammatory response is unknown. Acute     physical inactivity periods, commonly happens during daily life, related to work or acute     illness. New evidence points out that it induces immediate metabolic and endocrinological     changes, these can might also be associated with changes in immune response.      Aims of this project are:        1. to assess the effect of the precompetitive meal on the inflammatory, neuro-immune and          metabolic response to exercise;        2. to assess the effects of sedentary behaviour on inflammatory, neuro-immune and metabolic          response;        3. to assess differences in changes between healthy, asthmatic and obese subjects   "
96147|NCT02027662|"     Phosphate binders are crucial to the control of elevated phosphate levels in patients with     chronic kidney disease. With the new formulation of granules the pill burden of patients is     sought to be reduced.      This study is about efficacy and safety of the new drug formulation and compares it to the     old formulation which are film-coated tablets.   "
96148|NCT02027649|"     By an invasive technique keratin 14 has been identified as a prognostic factor in bladder     cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be     used as a diagnostic and prognostic marker for this cancer.   "
96149|NCT02027636|"     Our study tested the effectiveness of a combined cognitive behavioral therapy (CBT) and care     manager intervention offered either by telephone or face-to-face with depressed Latinos     identified in primary care. Eligible patients were randomized after baseline to one of three     conditions; 1) ECLA-T (telephone) intervention, 2) ECLA-F (face to face) intervention, and 3)     usual care. Usual care was considered care as usual in the participating clinic for a patient     screening or depression. The ECLA-T intervention was based on a     telephone-plus-care-management intervention that has been shown to be effective in decreasing     depressive symptoms and increasing client satisfaction and self-perceived global improvement,     as compared to usual care in depressed patients in primary care settings.   "
96150|NCT02027623|"     Exercise is one of the primary interventions used with people with chronic, mechanical low     back pain. It is unknown, however, which exercise is best for which person, which exercises a     person will adhere to and for how long, and the effect of adhering to a specific type of     exercise on how the person functions, particularly in the long run. The purpose of this study     is to examine if the short- and long-term effects are different between 1) commonly     prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized     practice in daily functional activities that are difficult or painful to perform. Adherence     to the different interventions, the relationship between adherence and outcomes,as well as     the effect of a booster intervention also will be examined.   "
96151|NCT02027610|"     Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young     children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation     (VAS) from 6-59 months of age to reduce the risk of death in countries where VAD is common.     Such countries include Bangladesh, where this study is being conducted. While providing VAS     at 6 months is recommended, providing VAS at birth may also decrease the risk of death since     newborn infants are also at risk of VAD. VAS presumably reduces infant mortality by improving     the immune response to infection and immunization. Vitamin A particularly affects the     development and function of T cells, which develop in the thymus and are a key component of     the memory response to infection and immunization. Vitamin A is important for development of     an important class of T cells, regulatory T-cells, in the intestine. Regulatory T-cells     prevent over-reaction of the immune system to substances the immune system might otherwise     treat as harmful such as food or the healthy bacteria in the intestine. VAD could disrupt the     normal colonization of the infant's intestinal tract and cause a condition called dysbiosis     where abnormal bacteria flourish and adversely affect the infant's immune system. Dysbiosis     may disrupt the immune response to injectable and oral vaccines. VAS at birth may prevent     dysbiosis and thus improve immune function, response to vaccines, and child survival. The     investigators recently completed an intervention trial in Bangladeshi infants (NCT01583972)     examining the effect of VAS at birth on immune function and response to vaccines administered     from birth to 14 wk of age. The present study will recruit infants who completed NCT01583972     when they are from 12 to 24 m of age to determine if VAS at birth affects the responses to     these same vaccines when they are measured during the second year of life. The investigators     will examine the effect of VAS at birth on gut microbiota measured early in infancy and     during the second year of life, and explore the association of the gut microbiota with     vaccine response. Mothers of study infants will participate in the study because the breast     milk oligosaccharide content strongly affects gut microbiota composition and the secretor     status of the mother, which can be determined from maternal FUT2 genotype, strongly affects     breast milk oligosaccharide content.   "
96152|NCT02027597|"     This study investigated if computer games can be effective at changing the way children take     care of their teeth. We a museum exhibit with 3D virtual reality games called Attack of the     S. Mutans! Our hypothesis was that children who played the games and visited the exhibit     would show improved attitudes about oral health, which would translate into improved brushing     and self-care habits.      In this randomized controlled study with school children aged 8-12, we compared the outcomes     for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on     classroom presentation about virtual reality being used for healthcare; Group 3) Received     no-treatment.   "
96153|NCT02027584|"     To study concentrations of choline, its metabolites, and phospholipids in cord blood and     remnants of clinically indicated blood samples   "
96156|NCT02027545|"     Systematic efforts to improve colorectal cancer screening use in the VA Healthcare System     have resulted in an increase in not only appropriate, but also inappropriate use of     screening. The purpose of this study is to test a new, more patient-centered approach to     colon cancer screening. In older individuals (ages 70 to 75) who are due for screening, the     investigators will provide education on the benefits and harms of colon cancer screening. But     instead of simply providing these patients with average information about these benefits,     the investigators will give them information that takes into account their personal     characteristics (e.g., age, gender), overall health, and screening history and therefore     applies to them more personally. The investigators will also work with the health system to     create time and space for patient and doctor to discuss whether screening is the right choice     for each individual. This way, patients can make an informed choice about what is right for     them, with the help of their doctor. In the future, the results of this study will help     patients make more informed screening decisions, especially when the benefits of screening     may be uncertain for them personally.   "
96157|NCT02027532|"     The purpose of this study is to compare the incidence rate of infection in surgical patients     with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the     peri-operative period.      The hypothesis of this study is that patients undergoing surgical treatment for closed     fractures who are treated prophylactically with Vancomycin will have a lower incidence rate     of infection than patients who are treated prophylactically with Cefazolin.   "
96158|NCT02027519|"     The purpose of this study is to gather information needed to develop a large prevention trial     to decrease risk for Human Immunodeficiency Virus (HIV) transmission among HIV-discordant     couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho. The     protocol team would like to explore new strategies for increasing the number of partners who     receive an HIV test and whether this increase in testing also results in identifying     HIV-discordant couples. These couples would be the focus of the future large prevention     trial, therefore it is critical that the protocol team explore effective strategies for     identifying and recruiting these couples. Men and women (index participants) who are     attending Antenatal Care (ANC),Tuberculosis (TB) and antiretroviral therapy (ART) clinics     will be recruited for this study. If they agree to take part, a testing team will visit their     household and offer all adults staying in the house the opportunity to conduct a self-test     for HIV. Seventy-ﬁve index participants will be enrolled into the study and have their homes     visited by the testing team. The number of household members tested will depend on the number     of people living in each household.   "
96159|NCT02027506|"     The electrocardiogram (ECG) is a simple and non-invasive bedside diagnostic tool with a     well-established role in the diagnosis of (CAD). Many studies have found that the admission     of ECG provides important prognostic information in patients admitted with chest pain. For     instance, T wave inversion in anterior or inferior location and or ST-segment depression has     been associated with high incidence of CAD.   "
96160|NCT02027493|"     Egypt has the highest prevalence of hepatitis C virus infection in adults (up to 20%) and     children (up to 5.5%). The major genotype (90%) is type 4. Pegylated interferon-alpha-2a or     -2b and ribavirin have been used in small numbers of hepatitis C virus-infected children with     sustained virological response being higher in genotypes 2 and 3 than in genotypes 1 and 4.     Genotype 4 is has been described as difficult-to-treat genotype. Several attempts to modify     treatment protocols have been tried in adults in an attempt to achieve higher rates of     sustained virological response. Shortening injection interval and/or treatment duration     prolongation have been tried with variable outcome reports.      A novel Hansenula- derived pegylated interferon alpha 2a: 20 Kilo dalton (Reiferon Retard)     has been used over the last 4 years in the Egyptian market.      We aimed to investigate the safety and efficacy of Reiferon retard plus ribavirin customized     regimen in hepatitis C virus-RNA seropositive Egyptian children. Forty six children with     chronic hepatitis C virus aged 3-19 years were selected from 3 hepatic tertiary centers.      Clinical and laboratory evaluation were undertaken. Quantitative polymerase chain reaction     (PCR) for HCV-RNA was done before starting treatment, at 4, 12, 24, 48, 72 weeks during     treatment and 6 months after stoppage of treatment. All patients were assigned to receive a     weekly subcutaneous injection of pegylated interferon alpha 2-a ( Reiferon Retard) plus oral     Ribavirin daily for 12 weeks ,then cases were divided according to PCR results into 2 groups.      Group I: Patients who continued treatment on weekly basis: this group included patients who     had negative PCR at week 12 as well those who had positive PCR without any change in viremia.     Group II: Patients who continued treatment on a 5- days schedule: this group included     patients who had any decrease in viremia at week 12.      Patients who were PCR-negative at week 48 and had at least one PCR-positive test during     therapy were assigned to have an extended treatment course of 6 months duration.      The occurrence of adverse effects was assessed during treatment and follow up   "
96161|NCT02027480|"     The aim of this study is to develop and follow a cohort of human immunodeficiency virus     (HIV)-infected adults who are starting HIV drugs at health facilities in Kenya. Blood and     urine samples will be collected from all participants in order to establish a sample bank of     samples in order to further the understanding of the levels of inﬂammatory biomarkers and     coagulation biomarkers in African patients and the effect of taking HIV drugs on these     biomarkers. This study will enroll and follow 685 men and women who are starting HIV drugs     and collect blood and urine specimens from them at 4 study visits. These samples will be     frozen and stored for future testing related to inﬂammatory and coagulation biomarkers.   "
96162|NCT02027467|"     Combination of various herbs is known to promote mobilization of hematopoietic stem cells.     Hence the current study has been intended to study the effect of Stem Alive® on mobilization     of stem cells. Stem Alive® include ingredients like green tea, ashwagandha, etc which are     known to be used as traditional medicine. They are also tested qualitatively in academic and     nutritional science research centers throughout the world and which substantially according     to those studies stimulate the augmented availability of circulating hematopoietic cells.     This study is projected to investigate the mobilization of stem cells on healthy human     volunteers.   "
96163|NCT02027454|"     This study is being conducted to comply with the Food and Drug Administration (FDA)     recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization     effects through electrocardiographic evaluation. Therefore, this study will evaluate the     effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead     continuous digital data in healthy adults. This study will evaluate the effect of three doses     of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to     placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity     of the study in detecting QTc change. This study consists of three treatment periods (each     separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last     dosing. The total duration of study including follow-up visit will be approximately 62 days.     Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical     assessments.   "
96164|NCT02027441|"     The purpose of this study is to gather information needed to develop a large prevention trial     to decrease risk for Human immunodeficiency virus (HIV) transmission among HIV-discordant     couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho.      The protocol team would like to explore new strategies for increasing the number of partners     who receive an HIV test and whether this increase in testing also results in identifying     HIV-discordant couples. These couples would be the focus of the future large prevention trial     therefore it is critical that the protocol team explore effective strategies for identifying     and recruiting these couples.      Men and women (index participants) who are attending antenatal (ANC) and Tuberculosis (TB)     clinics will be recruited for this study. If they agree to take part, a testing team will     visit their household and offer all adults staying in the house the opportunity to receive an     HIV test.      Three hundred index participants will be enrolled into the study and have their homes visited     by the testing team. The number of household members tested will depend on the number of     people living in each household.   "
96165|NCT02027428|"     Maintenance treatment of advanced stage squamous cell NSCLC   "
96166|NCT02027415|"     The study hypothesis is that drinking different juices will affect the body's responses to     air pollution. Subjects will be exposed to air pollution during a 2-hour car ride on the NJ     (New Jersey) Turnpike. Each subject will be asked to do this twice. Before one car ride, the     subject will be asked to drink orange juice. Before the other car ride, the subject will be     asked to drink beet juice. Samples of blood and exhaled breath will be collected before,     immediately after, and 24 hours after each car ride. Levels of nitrites/nitrates will be     measured in the blood and breath.   "
96167|NCT02027402|"     During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely     insert a drain. However, no consensus has been reached regarding the need for drainage in     these cases, and the use of a drain remains controversial. This study is coordinated to find     out the surgical outcomes and perioperative morbidity according to the insertion of drain     after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain     after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects     on the postoperative morbidity.   "
96168|NCT02027389|"     The objective of this study is to evaluate the impact of the Alere&#8482; PBP2a test combined     with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in     hospitalized patients with sterile site S. aureus infection.   "
96169|NCT02027376|"     This is a single-arm, open-label, phase Ib study. In this trial, patients with Triple     Negative (TN) Advanced Breast Cancer (ABC) will be treated with increasing doses of LDE225     and docetaxel to determine the MTD (Maximum Tolerated Dose), DLT (Dose Limiting Toxicity) and     RP2D (Recommended Phase II Dose) of the combination.      Eligible patients with hormonal receptors negative and HER2 negative ABC will be included and     treated with docetaxel intravenously in every three weeks cycles. LDE225 will be administered     orally at three dose levels 400, 600 and 800mg QD (a -1 dose level is included just in case     dose de-escalation is needed). Treatment will be repeated on day 1 of a 21-day cycle until     radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.      The investigators propose to develop a phase Ib trial with the combination of docetaxel with     LDE225 in TN ABC patients to define the safety, tolerability and RP2D, as well as to have     some information about the efficacy of the combination.      Primary Objective:      To determine the MTD and RP2D of LDE225 administered orally in combination with docetaxel in     TN ABC patients.      Primary End-point:      To determine the incidence rate of DLT within the first two cycles of LDE225 in combination     with docetaxel at each dose level.      Secondary Objectives:        -  To determine the safety and tolerability of LDE225 given in combination with docetaxel.        -  To characterize the effects of LDE225 in combination with docetaxel on QTc intervals and          their correlation with systemic drug exposure.        -  To evaluate the efficacy of the combination of docetaxel with LDE225 in TN ABC patients.        -  To evaluate the Pharmacokinetics (PK) of the combination of docetaxel with LDE225.      Secondary End-points:        -  Safety will be assessed by standard clinical and laboratory tests (hematology, serum          chemistry). Adverse events grade will be defined by the NCI CTCAE v4.0.        -  Changes in QT/QTc from baseline ECG values and correlation with systemic drug exposure.        -  The efficacy endpoints are Time To Progression (TTP) and Objective Response Rate (ORR).          TTP is measured from the initiation of treatment till disease progression and ORR is          defined by RECIST 1.1 criteria as complete response rate + partial response rate.        -  The PK will determine whether LDE225 influences the pharmacology of docetaxel. Blood          samples will be taken at the times defined in the protocol.      Exploratory Objectives:        -  To study potential predictive biomarkers of efficacy by evaluating activation of Hh          signaling pathway and related pathways.        -  To analyze the pharmacodynamic (PD) treatment effects on the expression of Smo related          biomarkers and Hg target genes in correlative samples.        -  To correlate biomarker, PD and PK findings with efficacy and toxicity data.      Exploratory End-points:        -  Hh gene expression signature associated to pathway activation (at least Shh, Smo, Ptch1,          Ptch2, Gli1, Gli2), analyzed in tumor samples.        -  Changes in Smo related pathway biomarkers (at least Gli1) in skin and blood correlative          samples.        -  Pharmacodynamic and biomarker analysis results will be correlated with PK findings,          efficacy and toxicity data.      Demographics and Baseline Characteristics:      Standard descriptive statistics, such as the mean, median, range and proportion, will be used     to summarize the patient sample and to estimate parameters of interest. Ninety-five percent     confidence intervals will be provided for estimates of interest wherever possible.      Safety Analyses:      Adverse events data and serious adverse events will be reported in frequency tables (overall     and by intensity). The safety analysis will be performed in the population that has received     at least one dose of the drugs.      Efficacy Analyses:      Response will be analyzed in patients with measurable disease that have received at least one     dose of the drugs.      TTP will be evaluated in all patients that have received at least one dose of the drugs.      Study population:      Patient with hormonal receptors negative and HER2 negative ABC.   "
96170|NCT02027363|"     Colorectal cancer is one of the most common malignant tumors, with the morbidity of     approximate 100 million cases per year. About 40% of patients present with metastatic (stage     IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion     will ultimately develop metastatic disease.      5-Fluorouracil（5-FU) was the only efficacious treatment for metastatic colorectal cancer     before the nineties of the 20th century, and afterwards as the discovery of chemotherapy such     as oxaliplatin, irinotecan and capecitabine, response rate as well as survival had been     improved greatly.      Most of advanced colorectal cancer will progress after first-line treatment; therefore,     seeking an efficient and low toxic maintaining regimen to prolong PFS becomes a hot topic in     oncologic field. Some clinical researches demonstrated that maintaining treatment followed     first-line treating advanced NSCLC could extend PFS and OS. In metastatic colorectal cancer,     patients receiving 5-FU/leucovorin(LV) maintaining therapy experienced significantly longer     PFS than that stopped chemotherapy after six cycles of FOLFOX4 in OPTIMOX2 study. One phase     II study shown that median PFS was 13.9 months, and median OS was 31 months in 30 patients     receiving first-line treatment of six- month FOLFOX4 followed by UFT as maintaining treatment     . A non-randomized small sample study conducted in department of medical oncology of Sun     Yat-Sen University Cancer Center indicated that patients receiving first-line treatment of     XELOX followed by capecitabine as maintaining therapy has significantly prolonged median TTP,     comparing with the non-maintaining treatment patients,(14months vs. 9 month, respectively).      Above all, so far, there is no data to demonstrate that regular 4-6 month chemotherapy     followed by maintaining treatment could prolong TTP and OS for advanced colorectal cancer.     Capecitabine is effective for colorectal cancer, and was approved as palliative treatment for     advanced colorectal cancer and adjuvant chemotherapy; in addition, with its relative less     frequency of side effects and convenient oral administration, capecitabine as maintaining     regimen could be prone to be accepted by patients. Therefore, our study is designed to     investigate that capecitabine as maintaining treatment after first-line palliative     chemotherapy could improve TTP and OS for patients with advanced colorectal cancer through a     perspective randomized clinical study.   "
96171|NCT02027350|"     Until now, diagnosis of constriction was based on pressure changes of ventricle by     conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This     study will provide answers to persisting questions about volume changes during respiration in     patients with constrictive pericarditis by directly measuring both right and left ventricular     volume.   "
96172|NCT02027337|"     We investigate parameters of hemocoagulation and lipoperoxidation in women using combined     oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg     ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants   "
96173|NCT02027324|"     There are approximately 1.4 million cesarean deliveries in the United States each year, and     an average of 1250 elective cesarean deliveries each year at the Brigham and Women's Hospital     (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH, approximately 2%     of patients are diagnosed with a surgical site infection (SSI). Because SSI is associated     with significant morbidity and increased cost of care, numerous guidelines exist to guide     preoperative administration of prophylactic antibiotics. However, there are no     recommendations for the choice of antiseptic solution for prevention of SSI. Among the     currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease     SSI in non-obstetric surgeries. However, the time required for CA to dry (~ 3 min) to     minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery.     Many institutions use povidone-iodine, another antisepsis preparation that does not require     the mandatory drying time. Our randomized study aims to compare the incidence of SSI in     patients receiving either CA or PI during elective cesarean delivery, and we hypothesize that     CA would be associated with a lower incidence of SSI.   "
96174|NCT02027311|"     Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A     receptor has been known that it maintains the appropriate sedative levels and affects little     effects on respiratory system.      The investigators are now trying to investigate that etomidate with meperidine combination     regimen is superior to the midazolam with meperidine more effective and less harm on sedation     during the ERCP procedure.   "
96175|NCT02027298|"     The primary purpose of this pilot study is to evaluate the efficacy and safety of Abatacept     in subjects with Sjogren's Syndrome (SS). This clinical trial study will enroll and treat 15     subjects with active moderate and severe inflammatory arthritis associated with primary     Sjogren's syndrome (pSS) and secondary Sjogren's sybdrine (sSS) with Rheumatoid Arthrits     (RA). All subjects will receive Abatacept weekly by Subcutaneous (SC) dosing. Subjects will     receive Abatacept by SC injection of 125 mg on day 1 and followed by 125 mg SC weekly     thereafter.   "
96176|NCT02027285|"     The study Nutritional trial with fortified milk in 65+ years old subjects is a part of a     complex research project and multi-sectoral development (MIAO 50) with the participation of     University Research Institutes and small and medium Italian enterprises.      The general objective of the call is to promote the collaboration between the best scientific     knowledge, both epidemiological and experimental, and the most advanced technologies to     develop foods with a nutritional profile adequate to the needs of consumers with an age over     50 years old, which are easy to use and make it possible to eat in a healthy manner, complete     and balanced and also meets the quality and flavors of traditional Italian.   "
96177|NCT02027272|"     This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more     quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome     (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or     steroid will receive standard therapy to include magnesium sulfate, blood pressure     medications and diuretics. We hypothesize that the addition of dexamethasone to standard     therapy will accelerate CNS recovery more quickly than standard management without     dexamethasone.   "
96178|NCT02027259|"     The purpose of this study is to determine whether group visits with added behavioral     activation (BA) for depression will have a greater clinical impact than our standard group     visits without BA for depression in reducing the risk of future coronary events as measured     by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms     as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.   "
96179|NCT02027246|"     The aim of this study was to study the effect of stem cell therapy on common symptoms of     spinal cord injury patients.   "
96180|NCT02027233|"     This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised     with laboratory-confirmed influenza through a network of hospitals in France.   "
96181|NCT02027220|"     RATIONALE: Bortezomib may stop the growth of myeloma cells by blocking proteasome activity.     Cyclophosphamide and dexamethasone may work in different ways to stop the growth of myeloma     cells by stopping them from dividing or by killing the cells. Granulocyte Clone Stimulating     Factor (G-CSF) possesses the ability to mobilize the plasma cells to detach from myeloma     niche, so as to promote drug sensitivity.      PURPOSE: This phase Ⅱ trial is to study how well combination of G-CSF, bortezomib,     cyclophosphamide and dexamethasone works in treating patients with multiple myeloma.   "
96182|NCT02027207|"     Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional     epidemics seen during times of floods, cyclones or any natural disaster. It affects all age     groups with the majority of fatal cases occurring in children . Therefore, immunization     against cholera remains an important public health component in the prevention and control of     the disease .The current two-dose regimen of the internationally available oral cholera     vaccines (OCV) create a logistical and programmatic challenge for use in national programs or     during epidemics ,so it is important to determine if a single dose vaccine will be protective     in regions where cholera is endemic. If the vaccine is found to be efficacious following a     single dose, this will have profound implications for the use of the vaccine in areas with     limited resources particularly in complex emergencies where a multiple dose regimen is     difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability'     and allow the vaccine to be used for outbreak control, especially in difficult settings where     the risk of cholera is extremely high and provisions for clean water and sanitation are not     available. With low OCV production rates, larger populations could be immunized against     cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate     the inclusion of a global stockpile strategy.      The study design is a two-arm individually randomized double-blind placebo-controlled trial.     The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or     placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study     treatment centres from 7 days to 6 months after dosage and whose identity is confirmed     through home visit.   "
96183|NCT02027194|"     The aim of this study is to test and compare the effectiveness between three groups -     Cure-Allergic Rhinitis Syrup (CS), Yuk ping fung San (YS) and placebo groups - of adolescents     (nursing students) with Allergic Rhinitis (AR) in improving their symptoms of AR, body     constitution pattern and health-related quality of life.      • The hypothesis are to test the effectiveness of the CS treatment on these students' AR     symptoms and quality of life at immediately, one month and two months after completion of the     4-week intervention, when compared with the YS treatment and placebo group.        1. Cure-Allergic Rhinitis Syrup (CS) group will show significantly reduction of AR symptoms          over the 2-month follow-up, when compared to those in YS and placebo groups.        2. CS group will indicate a healthier body constitution pattern over the follow-up, when          compared to those with YS and placebo group.        3. CS group will indicate significantly greater improvement of their quality of life over          2-month follow-up, when compared to those with YS and placebo group.   "
96184|NCT02027181|"     Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver     automatically oxygen in the emergency department in a patient population admitted for acute     respiratory failure.      Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses     and medical personnel and there are advantages to use this system. In comparison with the     common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a     better control of the oxygen saturation in function of designed target, reducing the     desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical     way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse     personnel.   "
96185|NCT02027168|"     This study will examine the impact of manual physical therapy on endocrine function in women     diagnosed as being infertile due to elevated follicle stimulating hormone (FSH) levels (10     mIU/mL or higher) on days 2-5 of their menstrual cycle. It is hypothesized that the manual     physical therapy will decrease FSH levels.   "
96186|NCT02027155|"     This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV     doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.   "
96415|NCT02024165|"     The specific goal of the proposed research is to develop a reliable, non-invasive fetal and     maternal heart rate and contraction monitor that is unaffected by obesity and requires less     nursing intervention than the tocodynamometer and Doppler ultrasound.   "
96188|NCT02027129|"     Recent data from large trials of high-frequency high frequency oscillation (HFO) without a     cuff leak vs, lung-protective conventional ventialtion (CMV) failed to show any HFO-related     benefit with respect to outcome. A possible explanation is that HFO increases the probability     of right ventricular dysfunction due to the combination of high mean airway pressures (mPaws)     and hypercapnia. In contrast, available preliminary data on low-frequency HFO-tracheal gas     insufflation (TGI) with cuff leak vs. CMV are suggestive of an HFO-TGI related benefit.     Low-frequency HFO-TGI with a cuff leak is associated with relatively low mean tracheal     pressures and adequate control of PaCO2. Thus, the investigators intend to test the     hypothesis that low frequency HFO +/- TGI with a cuff leak is associated with better right     ventricular function relative to high-frequency HFO without a cuff leak.   "
96189|NCT02027116|"     To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in     chronic hepatitis C patients   "
96190|NCT02027103|"     Oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay     of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups     of hypoglycemic medications that while function via different pathways, mare both effective     in short- and long-term glucose control. These medications diminish or delay long term micro-     and macrovascular complications associated with T2DM although at different rates. Excessive     insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM     subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis     formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to     modify successive CAD risk via direct and indirect amelioration of insulin     resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects     of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a     group of Iranian adults with newly diagnosed T2DM.   "
96191|NCT02027090|"     We hypothesize that higher dose icotinib is related with better efficacy. The primary     objective is to compare the progression-free survival of higher dose and routine dose of     icotinib in treating pretreated advanced non-small cell lung cancer patients with stable     disease after 8-week routine dose icotinib treatment.   "
96192|NCT02027077|"     Obesity is a major risk factor for disease and a public health problem. Recent information     suggests that while it is possible for most overweight adults to lose a substantial amount of     weight, maintaining the weight loss for any extended time (2 to 3 years) is very difficult.     This is because trying to maintain big changes in exercise and/or eating behaviour is very     difficult in today's environment that makes sustain big changes in behaviour (Example: eat     allot less or exercise allot more) very hard. In fact at this time health professionals are     unsure of how best to help overweight adults maintain big behavioral changes for long periods     of time. In response, we propose that making smaller changes in eating and exercise habits     every day may be possible in today's environment and if so, small weight changes may be     possible to maintain for long periods of time. This study is designed to assess whether     making small changes in eating and exercise behavior will be associated with sustained weight     loss over three (3) years. The results of the study may have important implications for     development of public health messages and clinical guidelines for prevention and treatment of     obesity through small changes in both exercise and eating habits.   "
96193|NCT02027064|"     molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell     transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.      Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.      the study is to evaluate the safety and efficacy of interferon for the intervention of     molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell     transplantation (allo-SCT)   "
96194|NCT02027051|"     This study aims at better understanding the genetic structure of the Armenians, an old     population whose genetics has not been the subject of many studies. We will study 500     individuals whom grandparents originate from different regions of Armenia. Each individual     will be genotyped using a large panel of genetic markers. Principal component analysis will     be used to analyze the genetic structure of this population.   "
96195|NCT02027038|"     Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of     limb muscles and ground reaction forces are different in patients with sacroiliac joint pain,     as compared to healthy controls.      Hypothesis II: The application of pelvic belts alters the alignment of the pelvic bones, the     electromuscular activation of the limb muscles or ground reaction forces.      Hypothesis III: The effects proposed in hypothesis II are different in patients with     sacroiliac joint pain, as compared to healthy controls.   "
96196|NCT02027025|"     Study of SPARC1103 in subjects wirth spasticity   "
96197|NCT02027012|"     REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the     percutaneous therapeutic treatment of medication-resistant hypertension in China.The primary     objective is to assess the efficacy performance of the Vessix™ Renal Denervation System for     the treatment of medication resistant hypertension on the basis of the hypothesis that the     percutaneous therapeutic renal denervation for the treatment of medication-resistant     hypertension using the Vessix™ Renal Denervation System will reduce systolic (SBP) and     diastolic blood pressure (DBP) at 6- month compared to baseline as accessed by office-based     blood pressure measurements.   "
96198|NCT02026999|"     The purpose of this study to determine the effectiveness of sugammadex in septoplasty     patients whose mask ventilation would be difficult after extubation.   "
96215|NCT02026778|"     Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea and     vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as     ondansetron. Involvement of multiple types of receptors and factors may be a reason for     inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1     receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness. Dizziness     is one of the cause of nausea and vomiting. This study is to compare the effects of     ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk patients     receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after gynecological     laparoscopic surgery.   "
96216|NCT02026765|"     The purpose of this study is to obverse the effect of this type lens in the same as     traditional aspheric intraocular lens at the same time, whether can further improve the     effects of operation.   "
96199|NCT02026986|"     Tear film consists of three layers including outer lipid layer, aqueous layer and inner mucin     layer.1,2 Lipid layer protects the aqueous layer of tear film from evaporation and mucin     layer adhere the tear film to ocular surface. Aqueous layer, which is produced in lacrimal     glands, is the most important in the health of ocular surface. Reduction of aqueous tear     secretion results in the disruption of homeostasis at ocular surface and leads to dry eye     syndrome.2 Dry eye syndrome is a common ocular surface disease associated with symptoms of     eye discomfort, grittness and visual disturbance.1,2 Dry eye syndrome disrupts normal     homeostasis at the ocular surface resulting in epithelial damage, epithelial cell apoptosis,     loss of goblet cells, and squamous metaplasia.1-3 The changes and inflammation of ocular     surface subsequently lead to tear instability, which causes an increased tear osmolarity and     aggravates the inflammatory cascades. This leads to a vicious cycle.2 The regulation of tear     film secretion is under neural and hormonal control.4 Dry eye syndrome has been associated     with diverse and multiple causes, including depressive disorder, drugs, hormonal status, and     systemic diseases.2 Sleep deprivation (SD) is known to cause profound impair¬ments in     executive function and vigilant attention.5,6 It is also reportedly associated with autonomic     and endocrine functioning7-9 and has been shown to increase blood pressure and stress hormone     levels and decrease parasympathetic tone.10,11 Tear secretion is regulated by neurological     factors and hormones,12 and so SD may have an effect on the tear film and ocular surface.     However, only a few studies have evaluated the effect of sleep on the tear film and ocular     surface.      In this study, we investigated the effect of SD on the tear film and ocular surface.   "
96200|NCT02026973|"     Endogenous estrogens maintain growth hormone (GH) secretion in postmenopausal women by     potentiating endogenous GH-releasing hormone (GHRH) drive and restraining somatostatin     inhibition of GH release.   "
96201|NCT02026960|"     The primary objective is to evaluate methods for AGS-003 production from surgical (stage I)     and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU     cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other     GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from     total tumor RNA isolated from tissues obtained by core needle tumor biopsy.   "
96202|NCT02026947|"     The aim of this study is to investigate whether sodium benzoate is superior to placebo in     decreasing symptoms among patients with attenuated/transient psychosis. A total of 140     patients will be randomized in 1:1 ratio to receive sodium benzoate 1 g/day or placebo for 12     weeks. Concerning statistical power, the number of patients is sufficient to obtain     statistical significance for a clinically meaningful effect size of 0.40 (Cohen's d). The     primary outcome measure is change in PANSS sum score of delusions, hallucinations,     suspiciousness and conceptual disorganization (the PANSS items that are inclusion criteria)     at week 12. Change in CGI score at week 12 is the other primary outcome measure. The     secondary outcome measures are change in PANSS total score at week 12, CGI score at week 24,     and GAF at weeks 12 and 24.   "
96203|NCT02026934|"     CliniMACs is an investigational device used to select and enrich stem cells. The device will     select the stem cells with CD34+ protein. The participant will be infused with the CD34+     selected cells in the hopes that it will help the participant engraft. Engraftment is when     transplanted stem cells resume production of healthy blood cells.   "
96204|NCT02026921|"     A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive     relapse of epithelial ovarian, peritoneal or tubal cancer.      Hypothesis: Treatment with this combination in second line is safe and with a low frequency     of neurologic side effect.   "
96205|NCT02026908|"     This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate     artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to     benign prostatic hyperplasia (BPH).   "
96206|NCT02026895|"     The main objective is to identify new virulence factors produced by Staphylococcus     lugdunensis that can be associated with clinical sign of severe infections and identified     symptoms. The methodological approach is based on the comparison between the production of     toxins by a given S. lugdunensis isolate classified in patients groups according to the     infection clinically defined. Each group will be compared to the presence or not of studied     virulence factors. Clinical features associated with toxin activity are not known for S.     lugdunensis. This comparative approach is based on the hypotheses that drove to the     definition of patient groups and their clinical criteria. However, in the absence of the     evident correlation between production of toxins and kind of infection, the statistical     evaluation will be completed by a multi-varied analysis. This approach has not been choosen     first because of the multiple parameters that undergo during infection that may reveal     relationships without true correlation. About the number of included patients in each defined     group, if one of them does not reach the expected count, we still might extend inclusions to     3-6 months more. The presence of severe infections without usually defined risk is     intriguing. For these last patients, we have planned, after their individual consent to     achieve an exome sequencing. The obtained data will be compared to available resources for     the human genome. By filtering data through usual protocols, we hope to able to focus onto     few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S.     lugdunensis without defined risk.   "
96207|NCT02026882|"     The Supreme Laryngeal Mask Airway (SLMA) is a single use supraglottic device that provides a     good seal for positive pressure ventilation and good first attempt insertion rate of 98% in     low risk patients undergoing elective Caesarean section. It has a double aperture design that     facilitates the introduction of an orogastric tube to aspirate gastric contents.      The primary study hypothesis is the first attempt insertion success rate of SLMA use in     urgent Caesarean section.   "
96208|NCT02026869|"     Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay in     achieving pregnancy. Certain drugs may help improve ovarian activity in such women as     metformin. Oral administration of metformin is accompanied by undesirable side effects. The     vagina proved to be a good alternative to the oral route for other drugs. Using metformin     through the vagina and avoidance of such side effects, while maintaining its effectiveness,     would help women to better tolerate this drug.   "
96209|NCT02026856|"     This study looked at parenteral administration of selenium to septic patients and     subsequently monitored dynamic changes of selected activities of antioxidant enzymes and the     development of clinical status.   "
96217|NCT02026752|"     The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1)     infected individuals that have viral loads across the dynamic range of the Aptima HIV-1     assay. The plasma samples will be tested in a method comparison study to support the approval     of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method     comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing     the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New     Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1     assay.   "
96218|NCT02026739|"     The study hypothesized that a relative low oxygen concentration (40%) supplemental would be     advantageous to protect the pulmonary function of patients, comparied with conventional high     oxygen concentration (80%). Therefore we raise this prospective randomized controlled     research.   "
96219|NCT02026726|"     The purpose of this observational study is to show whether a standard oral steroid dose pack     can be used as a screening tool to assess the effectiveness of a subsequent epidural steroid     injection (ESI). If an oral steroid does not give a patient significant temporary relief of     pain from a herniated lumbar disc then an epidural steroid injection will not either.     Therefore the risk and expense associated from the interventional pain management procedure     for those patients could be avoided and other treatment modalities pursued.   "
96220|NCT02026713|"     All consecutive patients undergone PTCA in the period between July 2013 and December 2013 are     eligible to be enrolled. Study population are divided in :      Group 1: smokers on dual antiplatelet therapy with ASA (100 mg once a day) and Prasugrel (10     mg die); Group 2: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and     Ticagrelor (90 mg twice a day); Control group: smokers on dual antiplatelet therapy with     ASA(100 mg once a day) and Clopidogrel (75 mg once a day).      Platelet function is evaluated using a validated method: the VerifyNow System (Accumetrics     Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system     that measures platelet-induced aggregation. These value are measured Platelet function,     measured with the VerifyNow P2Y12. All patients on chronic dual antiplatelet therapy (>1     month) quit smoking for a 2 weeks period. Therefore PRU values are obtained at baseline (at     the enrollment time) and after 2 weeks after smoking cessation. Platelet reactivity are     expressed in P2Y12 reaction units (PRU). PRU values >240 are suggestive of high platelet     reactivity.      Primary outcomes: P2Y12 reaction units (PRU) at baseline and two weeks after quitting     smoking.   "
96221|NCT02026700|"     We intend to evaluate the efficiency and tolerability of a barrier cream (bariederm) in     protecting hands of individuals with hand dermatitis, either due to allergy or irritation. We     believe that the use of the cream would benefit with the skin.   "
96222|NCT02026687|"     The purpose of the study is to compare epidural analgesia and intrathecal analgesia for     explorative laparotomy through a middle-line incision for gynecological cancer in a fast     track program to se if there is any difference in recovery. Length of stay is analyzed     together with self-rate quality of life.   "
96223|NCT02026674|"     The FloRite™ device is a disposable urine flow meter, indicated for use in a home setting.      The device provides Urofowmetry measurements, similar to clinic's measurements. Clinic-based     uroflowmetry has some flaws; the setting is artificial and often it is difficult to void at     the desired moment. Moreover, a single measurement of the voided parameters is a poor     representative of the patient condition due to high variability of the measured parameters.     Performing multiple Urofowmetry measurements provides representative and more accurate     results, in a more patient-friendly, cost effective method.   "
96224|NCT02026661|"     To determine the association of factors affecting the clinical pregnancy and live birth rates     in patients undergoing in vitro fertilization (IVF) who received intracytoplasmic sperm     injection (ICSI) and/or laser assisted hatching (LAH) or neither.      After applying the inclusion and exclusion criteria, a total of 400 women who underwent IVF     between January 2007 and December 2010 were included in the analysis. Patients were divided     into 4 groups; 1) those that did not receive ICSI or LAH, 2) those that received ICSI only,     3) those that received LAH only, and 4) those that received both ICSI and LAH. Univariate and     multivariate analyses were performed.   "
96225|NCT02026648|"     Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed     countries over the past 40 years, however, there has also been an increase in relative and     absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix     over the same period.      Our understanding of the natural history and optimal management of AC is limited. It appears     that AC and SCC of the cervix behave differently. They are different in epidemiology,     prognostic factors, and patterns of failure after similar treatments. Available data suggest     that they may also differ in their response to treatment. We postulate that new treatment     strategies specifically tailored to AC should be explored.      However, there is few data about outcome of cervical cancer in Taiwan. So we propose this     proposal for retrospective analysis of clinicopathological parameters and outcomes in     patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous     carcinoma.   "
96226|NCT02026635|"     A research study to determine if heart failure can be medically managed using data collected     from cardiac monitoring devices   "
96227|NCT02026622|"     The main objective is to compare the physiological reactivity (heart and respiratory rates,     galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion     between depressive subjects, subjects remitted from depression and control subjects.   "
96228|NCT02026609|"     Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients     with cirrhosis and refractory ascites. However, mental changes known as hepatic     encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE     after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess     the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also     predispose patients to HE. The aim of the present study is to assess if both the OGC and     psychometric tests can accurately predict the development of overt HE after TIPS. Patients     will be studied before TIPS and followed after TIPS for the development of HE. The role of     muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be     investigated.   "
96241|NCT02026440|"     The VioOne Oral Fluid Sample Collection Device can be used to collect human oral fluid     samples for detection of cotinine using an ELISA cotinine assay.   "
96229|NCT02026596|"     Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about     1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a     mortality rate of 12 % acutely and 40 % of patients die within a month from admission to     hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most     survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from     the insult.      Despite the advances in neurosurgical and -radiological techniques and intensive care, the     mortality and morbidity rates in SAH have not changed in recent years. There is still only     limited understanding of the mechanisms of secondary insults causing brain injury after SAH.      In this study the investigators are aiming to clarify the timescale and mechanisms     contributing to the secondary insults. The investigators also explore usability of novel     biomarkers to guide treatment of the patients suffering from SAH.   "
96230|NCT02026583|"     1. Study Objectives 1) Primary Objective: Progression-free survival 2) Secondary          Objectives:             1. overall survival             2. response rate             3. incidence, nature and severity of all adverse events             4. lipid lowering effect of simvastatin             5. exploratory biomarker analysis : angiopoietin 2, BiP (Binding protein), Hsp (Heat               shck protein) 90α        2. Study hypothesis In our recent in vitro study, addition of simvastatin to bevacizumab          reduced proliferation, migration, invasion and tumor formation of endothelial cell.          Moreover, colorectal cancer cell media which was treated with simvastatin combined with          bevacizumab inhibited endothelial cell invasion and it was associated with decreased          mediator of angiogenesis, such as angiopoietin 2, BiP and HSP 90α.. Treatment with          bevacizumab and simvastatin more reduced the growth of xenograft tumors compared with          bevacizumab alone.        3. Assessments 1) Safety : physical examination, vital signs, body weight, ECOG (Eastern          Cooperative Oncology Group) performance status, clinical laboratory evaluation          (chemistry, blood cell count) and any AE (adverse effect) graded by using CTCAE (Common          Toxicity Criteria for Adverse Effects ) v 4.0 2) Efficacy : progression-free survival          and overall survival will be collected. Response rate according to RECIST (Response          Evaluation Criteria in Solid Tumors) 1,1 guideline will also be evaluated 3) PFS          (Progression free survival): time from randomization to tumor progression or death 4) OS          (Overall survival) : time from randomization to death or last follow-up 5) Biomarker          analysis; The correlation between blood level, protein expression of angiopoietin 2,          BiP, Hsp90α and clinical response will be explored.   "
96231|NCT02026570|"     Objectives: The purpose of this study is to investigate attentional (internal vs. external)     focus effects on persons with amputation to perform a defined compensatory movement to reduce     the likelihood of a fall. An internal focus of attention directs a person's conscious     attention to their body's movements, whereas an external focus of attention directs a     person's conscious attention to the effects of their movements or specific features in the     environment. Numerous experiments have investigated the effects of an internal and external     focus of attention on motor performance and the findings are in favor of an external focus of     attention. In our work, we propose a motor learning research experiment to evaluate     attentional focus strategies on the rehabilitation outcomes of learning and adaptation to the     new proprioceptive information for persons with a recent transtibial amputation.      Research Design and Methodology: For this pilot study, six participants with recent     unilateral transtibial amputation will be recruited. Four participants will receive internal     and external focus of attention training methods while the other two (control group) will     receive standard prosthetic training instructions. The experiment will be conducted in three     phases: Phase 1 -- Baseline Performance Test, Phase 2 -- Training sessions, and Phase 3 -     Learning Test. The training will utilize a vibrotactile device designed to generate tactile     sensations at the skin-socket interface simulating contact of the prosthesis with the     environment. The sensation simulates a perturbation that signals a potential fall event.     During the experiment the augmented sensory information will be introduced randomly while     participants walk at a preferred pace on a level surface. Movement kinematics and kinetics of     the body will be recorded for analyses using a motion capture system with force plates.      Finding: It is hypothesized that the external focus of attention condition will outperform     the internal focus of attention condition when responding to perturbations. The external     focus of attention condition will yield faster response time and show improved compensatory     responses compared to the internal focus of attention group by producing a greater lateral     displacement of the artificial limb relative to the line of progression. In addition, the     external condition will demonstrate a greater step length and step height than the internal     focus of attention condition when provided with a perturbation.      Clinical Significance: Current practices within the field of Physical Therapy reveal that     there is little therapeutic intervention for fall prevention. Instructions are traditionally     provided on how to reduce the risk of falling through preparation of a room or obstacle     avoidance or on the proper way to fall to decrease injury. However, there are no protocols     for providing a prosthetic user with compensatory strategies to avoid a fall after a     perturbation occurs. The research findings can result in improved training protocols, which     can improve rehabilitative outcome.      Impact/Significance: The growing number of prosthetic users presents a need for improved     patient care and effective prosthetic training and rehabilitation methods. Complimentary to     the mission of the VA, the results of this research could enhance the quality of patient care     and further assist these patients toward becoming prosthetically rehabilitated.   "
96232|NCT02026557|"     To describe mortality among children with congenital heart defects in Norway   "
96233|NCT02026544|"     The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic     Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.   "
96234|NCT02026531|"     The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At     present cardiac catheterisation is the cornerstone investigation in these patients where it     is used to establish disease severity and estimate prognosis. It is an invasive procedure     which is expensive and not without risk to the patient. Despite the multitude of tests     performed, identifying those patients with PH who have a poor diagnosis can be difficult. The     aim of this study is to improve the assessment of patients with PH using novel magnetic     resonance techniques.   "
96235|NCT02026518|"     Fasting blood specimens will be taken from the patients with IBS that have inclusion     criteria. First, the objectives and method of study will be explained to the patients and     informed consent form will be taken from them. They will be divided into 4 groups by an     adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress     questionnaires will be completed before and after intervention. During 6 weeks, they will     receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the     other placebo form, both of them and placebo of both. At the end, body mass index ( BMI),     serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut     permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen     receptors will be determined.   "
96236|NCT02026505|"     The purpose of this study is to learn more about how a drug commonly used to treat multiple     myeloma can affect the heart.      In this study, the investigators will learn whether a drug called how a drug (called     bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of     the standard treatment and its effects on multiple myeloma is not being studied here.      The investigators want to learn whether damage occurs to the heart after taking bortezomib     for multiple myeloma, whether it is reversible, and we can predict damage to the heart before     it occurs.   "
96237|NCT02026492|"     The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to     the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced     bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured.   "
96238|NCT02026479|"     The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have     obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic     injection is the latest findings in clinical work and a new noninvasive way of administration     which is gradually expanding research. The aim of this experiment is to verify and explore     the efficacy and safety of the postauricular injection treatment with different doses of     Glucocorticoids.   "
96239|NCT02026466|"     This is an observational registry, sponsored by Saint Luke's Hospital. This study is to be     conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies     and procedures. The overall objective is to address current gaps in knowledge regarding     CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.   "
96240|NCT02026453|"     We will test two interventions to improve the accuracy of medication histories obtained at     hospital admission. The interventions will target elderly and chronically ill patients prone     to erroneous medication histories and resultant medication errors. For targeted patients, we     will test the effect of using pharmacists and pharmacy technicians to obtain an initial     medication history. This will be studied using a randomized controlled trial of usual care     (which involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy     technicians to obtain an admission medication history.      Our overarching hypothesis is that by leveraging pharmacists and pharmacy technicians we can     minimize admission medication history errors and related downstream events.   "
96242|NCT02026427|"     The participants were hospitalized in Orthopedic and Traumatology Departments in Military     Institute of Medicine, Warsaw, Poland.      The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and     (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered     during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder     catheterization was perform during the surgery were excluded from the study.      The participants were randomly divided into the study and control groups. No oral     premedication was administered. All the patients were asked to empty their urinary bladders     before arrival to the operating theatre. When the standard monitoring (continuous     electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous     premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric     0.5% solution of bupivacaine hydrochloride was performed.      In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride     was administered intramuscularly. The decresed intravascular volume was corrected with     cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay     scale, level of sedationt was obtained with midazolam and/or propofol. All the participants     received a questionaire in which we asked the questions about (1) the duration of anesthesia,     (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower     abdomen, (4) the incidence of the urinary bladder catheterization and time to     catheterization. On the next day after the surgery the questionaires were collected. In     cases, when the patient's dischaged from the hospital was planned during the weekend, he or     she was asked to pass on the questionaire to the nurses.   "
96243|NCT02026414|"     PrimaVie (Natreon Inc), is a a purified and standardized shilajit extract for nutraceutical     use. Research indicates that PrimaVie® has targeted action for increasing energy,     revitalization and anti-aging. Findings on a recent murine study revealed that PrimaVie (PV)     significantly changed the expression of genes related to muscle function (unpublished data).     Based on these facts, it was thought of interest to study the effect of PrimaVie and exercise     training on human skeletal muscle adaptation.      The objective of the study is to determine effect of PrimaVie supplementation and combined     PrimaVie supplementation and exercise on changes in muscle gene expression related to muscle     function. Two hypothesizes have been made, oral supplementation of PrimaVie twice a day for     12 weeks will influence gene expression in the skeletal muscle of pre-obese to obese humans,     oral supplementation of PV will act with treadmill exercise training to favorably impact     skeletal muscle gene expression. The participants will have a total of 3 visits over 12     weeks. During each visit will include measurement of height, weight and vital signs, 2     tablespoons of blood will be draw from left or right arm, and muscle biopsies (using biopsy     needle) will be collected under the use of local anesthetics. The blood and muscle biopsies     will be used for all lab related procedure.   "
96244|NCT02026401|"     The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in     patients with Primary Biliary Cirrhosis.   "
96245|NCT02026388|"     This study is being done to obtain samples from patients with primary hyperoxaluria,     cystinuria, adenine phosphoribosyl transferase (APRT) deficiency, and Dent disease, and from     their family members, for use in future research.   "
96246|NCT02026362|"     To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group'     in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in     China.   "
96247|NCT02026349|"     The purpose of this study is to determine if favipiravir is effective in reducing the time to     resolution of influenza symptoms.   "
96248|NCT02026336|"     Patients with persistent asthma have different inflammatory phenotypes. The electronic nose     is a new technology capable of distinguishing volatile organic compound breath-prints in     exhaled breath among different pulmonary diseases.      Question of the study. Is the electronic nose breath-print analysis able to discriminate     among different inflammatory asthma phenotypes?   "
96249|NCT02026323|"     Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic     ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term     risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical     stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve     insulin sensitivity. Whether these findings can be translated into women with PCOS has not     been investigated. Therefore, this study aims to evaluate whether acupuncture improves     insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis is     that acupuncture with combined manual and low-frequency electrical stimulation of the needles     improves insulin resistance, induces ovulation and improves quality of life.   "
96250|NCT02026310|"     All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and     evidence is sufficient.At the same time the basal insulin injection once a day are more and     more widely used in diabetes patients in China.      This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes     patients with inadequate glycemic control with combined therapy of metformin and basal     insulin.   "
96271|NCT02026037|"     The investigators propose to develop and pilot-test a short-term cognitive-behavioral     treatment (CBT) for hospitalized survivors of acute burns, in order to reduce posttraumatic     symptoms before they consolidate into long-term posttraumatic stress disorder (PTSD). This is     important because approximately one third of burn survivors develop PTSD after discharge.     PTSD is associated with extended psychological suffering and a greater need for medical     services in the future. Although there are treatments for chronic PTSD, there are far fewer     interventions available to treat acute posttraumatic symptoms before they develop into this     disorder, and none to date has focused on adult burn survivors. The little research available     on other forms of trauma suggests that interventions developed to treat PTSD may be helpful     in preventing PTSD when used in the first weeks following a trauma.      The investigators will develop a six-session intervention package for use with patients at     the Los Angeles County + University of Southern California Burn Center. The intervention will     translate CBT principles that have been validated with trauma survivors, but will be adapted     to hospitalized burn patients. After manual development, we will pilot-test this treatment on     15 patients who are medically stable, and not critically ill, intubated, or delirious.     Treatment will consist of three 50-minute CBT sessions per week, involving     mindfulness-focused relaxation training, graduated exposure to memories of the burn,     psychoeducation, and cognitive restructuring. Assessment will include standardized tests of     posttraumatic stress, anxiety, and depression, administered at the initiation and termination     of treatment, and at one-month follow-up. Also assessed will be number of hospital days to     discharge and participant satisfaction with treatment. We will evaluate the overall     feasibility of conducting a study on PTSD prevention in burn survivors, as measured by     initial recruitment success, subsequent dropout rates at the end of treatment and at the     one-month follow-up, and participant satisfaction. These data will then be used to support a     subsequent application for funding of a larger-scale randomized clinical trial (RCT) study.   "
96251|NCT02026297|"     The aim of this study is to characterize the coagulation changes, using thromboelastography     (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically,     TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo     before surgery, during elective cesarean delivery, and 2 hours postpartum.      Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing     interest in multimodal approaches to blood conservation during cesarean delivery.     Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown     to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global     coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not     been elucidated.      This study will be conducted as a randomized, double-blind, controlled trial with two study     arms: control (60 patients); and treatment (60 patients).      Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral     sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and     noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum     hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT),     prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum     amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured     throughout surgery as per standard of care. Patients will all receive IV lactated Ringers'     (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of     less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal     anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and     hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general     anesthesia conversion, general anesthesia planned), indications and medication doses used     will be noted for analysis.      Immediately following induction of anesthesia and prior to skin incision, infusion of study     solution will be initiated.      Study solutions will consist of:        1. Control group: 100 mL 0.9% normal saline (NS).        2. Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will          be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual          estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured          throughout the study. All routine care lab values will be noted. At minimum, one lab          panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen,          platelet count, aPTT, PT, and TEG).   "
96252|NCT02026284|"     The investigators aim to evaluate the preferences for anaesthesia methods of gravid women who     are to deliver baby by caesarean section, the rates of general anaesthesia and regional     anaesthesia, the reasons for preferences of general anaesthesia and regional anaesthesia and     the factors affecting these preferences.      A questionnaire consisting of 20 questions were applied to gravid women applying for delivery     by elective caesarean operation, at Ankara University Faculty of Medicine Hospital for     Gynaecology and Obstetrics between February 2010 and February 2011, in order to study the     anaesthesia technique the patients prefer and the reason behind their preferences. Those     gravid women who accepted to take part in the study were provided information about the     questionnaire and their oral and written approvals were obtained.   "
96253|NCT02026271|"     This research study involves two investigational drugs, veledimex, an activator ligand     (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12     (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by     enhancing the ability of the immune system to kill tumor cells and may interfere with blood     flow to the tumor.      The main purpose of this study is to evaluate the safety and tolerability of a single tumor     injection of INXN-2001 given in combination with oral veledimex.   "
96254|NCT02026258|"     The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure     will have a transient acceleratory effect on the rate of tooth alignment and the overall     treatment time. In addition, the subjects in the piezotome-corticision orthodontics group     will experience a different level of pain, comfort, and satisfaction as opposed to the     conventional orthodontics group.   "
96255|NCT02026245|"     In this study we will compare two electronic goniometric gloves to see if they can be used in     research on joint movement in arthritis.      One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other     is a glove that we have specially designed and developed for use in people with arthritis.     Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints.      We aim to find out if the gloves are accurate and if they can be worn and used without too     much discomfort by people with arthritis.   "
96256|NCT02026232|"     The basic plan of the study is to randomize otherwise healthy subjects with type 2 diabetes     to hydroxychloroquine, 200 mg twice daily or placebo.   "
96257|NCT02026219|"     Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than     clopidogrel and is associated with less interindividual variability. In the PLATO trial, it     was found to be superior to clopidogrel with respect to cardiovascular outcomes and total     mortality without increasing the risk of bleedings.      More potent and reversible receptor bindings are possible explanation for the superior     outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has     previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake     in tissue level and can induce adenosine triphosphate (ATP) release from human red cells,     which both stimulate vasodilation of in red blood cells.   "
96258|NCT02026206|"     The purpose of this study was to evaluate the effectiveness of a self-therapeutic approach of     skin adhesive low-level light therapy (LLLT) in females with primary dysmenorrhea (PD).   "
96259|NCT02026193|"     The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because     of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the     investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the     introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to     freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.      The purpose of this study is to compare the outcome of these two approaches.   "
96272|NCT02026024|"     Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1     (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by     boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly     controlled Type 2 diabetes patients. This study is designed to understand the pharmacological     effects and genetic variation of incretin based therapy on type 2 diabetes.   "
96273|NCT02026011|"     This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene     on biobehavioral and neural markers of response to naltrexone in individuals of East Asian     descent, an ethnic group most likely to express the positive predictive allele.   "
96274|NCT02025998|"     The objective of this proposal is to advance medication development for alcoholism by     conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and     phosphodiesterase inhibitor, for alcohol use disorders.   "
96275|NCT02025985|"     The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in patients     with advanced or metastatic gynaecological cancers by disease control rate (complete response     (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed     according to RECIST 1.1 criteria).   "
96260|NCT02026180|"     Vascular access complications can occur during or after cardiac or peripheral arterial     catheterization. These complications increase patient morbidity and mortality, as well as     healthcare costs. Several strategies and devices have been employed to decrease the risk for     vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access     and vascular closure devices. Randomized trial data has failed to demonstrate that     fluoroscopic guidance reduces common femoral artery access complications. While meta-analysis     data has demonstrated that vascular closure devices decrease time to arterial hemostasis,     increase patient mobilization and facilitate earlier patient discharge, they do not reduce     the incidence of vascular complications as compared to hemostasis achieved with manual     pressure. Ultrasound guidance has been shown to facilitate femoral artery access and reduce     femoral artery vascular complications. A new device, the Micropuncture Kit (Cook Medical,     Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to the     standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for the     purpose of decreasing vascular access complications has not been examined in a randomized     study to date.      The present study is a 552 patient randomized controlled clinical trial that will help     determine whether femoral arterial access obtained using the Micropuncture Kit will reduce     the incidence of vascular access complications compared to the standard 18 gauge needle.      The specific aim of this proposal is to compare the rate of femoral artery access     complications using the Micropuncture Kit vs. standard femoral artery access.      It is our hypothesis that the incidence of femoral artery access complications will be lower     among patients in whom the Micropuncture Kit is used.   "
96261|NCT02026167|"     The objective of this study is to test the effectiveness of a collaborative care approach to     improving outpatient treatment for inactivity, chronic pain and depression as a way of     improving overall Quality of Life for patients with SCI.   "
96262|NCT02026154|"     The study objective is to clarify the grounds of heart exertional dyspnoea stenocardia in     patients with well-controlled stage I or II hypertension according to European Society of     Hypertension, without changes in epicardial coronary arteries in CT coronary angiography and     normal resting echocardiography result, and to assess of potential early markers of heart     hypertrophy and failure in patients with hypertension.   "
96263|NCT02026141|"     Dexmedetomidine has been often used for procedural sedation. It has also has been shown to     have a pain sparing effect. Therefore the investigators propose that if Dexmedetomidine is     used for sedation in total knee replacements done under spinal anesthetic, the patients will     have less pain up to 24 hours after the procedure.   "
96264|NCT02026128|"     Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide     micrometer (one one-thousandths) scale imaging of biological tissue. This allows excellent     assessment of the white blood and inflammatory cells seen in uveitis, an inflammation of any     or all parts of the uvea (iris, ciliary body, choroid).   "
96265|NCT02026115|"     The study purpose is to compare usual hospice care and PAINRelieveIt groups for effects on:     (1) patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and     misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250     cancer patient-caregiver dyads receiving hospice care; and (2) nurse outcomes (obtained     appropriate analgesics for patient) in a sample of hospice nurses. The investigators     hypothesize that at posttest, controlling for pretest data and compared to the usual care     group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and     pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a     larger proportion who report satisfaction with pain intensity and whose nurses obtained     appropriate analgesics for the patients' pain.   "
96266|NCT02026102|"     The purpose of this study is to test the acceptability and feasibility of a toolkit of     patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.   "
96267|NCT02026089|"     The purpose of the study is to learn more abou how the immune system responds to the     chickenpox vaccine in adults who had never had chickenpox as a child and were then vaccinated     as an adult. The study aims to learn more about the strength and duration of the protection     provided by the vaccine in adults, and to observe the immune response to an additional dose     of chickenpox vaccine in adults who had received the vaccine at least 5 years earlier. This     is especially relevant to workers in a hospital who may be exposed to chickenpox.   "
96268|NCT02026076|"     This study will seek to determine if 1) the manual unloading test is reliable, and 2)if the     immediate response to traction can be determined by using a simple unloading test in     standing. The study wil be completed in two parts: 1) a small pilot sample (n=10) to asses     both intra and inter tester reliability, and 2) a consecutive sample of 30 patients with low     back pain which does not travel below the knee. All subjects will rate their pain on a 100 mm     line both at rest and in their most painful direction of movement. A therapist will then     unload the patients spine to determine if they feel any relief. All subjects will then     undergo a 15 minute bout of intermittent lumbar traction, 30 sec on, 10 sec off at up to 50%     body weight. Following traction, all subjects will again rate their pain on a 100 mm line.     Subjects will be grouped by response to the initial manual unloading test and assessed for     within and between group differences. The study hypothesis is that the manual unloading test     is reliable, and that responders to mechanical traction can be accurately identified using a     manual unloading test.   "
96269|NCT02026063|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     orally administered telotristat etiprate.   "
96270|NCT02026050|"     the aim of this study was to investigate the analgesic efficacy of intra articular     dexamethasone administration for arthroscopic shoulder surgery.   "
96276|NCT02025972|"     This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic     umbilical cord blood therapy for children with cerebral palsy.   "
96301|NCT02025647|"     Innerview can address some of the challenges of integrating mental health and primary care by     accurately and reliably collecting mental health evidence and activities directly from     patients, and then organizing and automating that evidence and activity into reports for     providers and care teams that support diagnosis, treatment planning and monitoring of the     mental health issues within a practice population.   "
96277|NCT02025959|"     Getting better sleep in the hospital is especially important due to a variety of adverse     health effects that can potentially worsen patient recovery.      To address these concerns and improve sleep in US hospitals, we aim to develop the SIESTA     (Sleep for Inpatients: Empowering Staff to Act) program as an educational intervention     designed to prepare hospital staff to assist patients in obtaining better sleep in hospitals     and recognize the importance of screening for sleep disorders. The major educational goals of     this proposal is to develop and pilot test an online educational program (SIESTA) which aims     to train and motivate medical professionals to provide better sleep for hospitalized     patients.      We will utilize data from an ongoing sleep study, performed by the research team at the     University of Chicago that looks at how adult patients are able to sleep while they are in     the hospital, as a means of education for the participating medical staff.   "
96278|NCT02025946|"     In case of severe ankle arthritis, the two common surgical treatments are tibiotalar     arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it     remains difficult to determine which operation is the better solution for end stage ankle     arthritis.      The purpose of the present study is to analyze patient's outcome after each type of ankle     surgery and to describe the decision making process.   "
96279|NCT02025933|"     It has previously been seen that increased fish intake improves the metabolic health of     overweight and obese adults, and animal protein improved metabolic health of obese rats. In     this project the investigators will investigate whether increased intake of fish or meat     improve metabolic health in children aged 9-12 years as well when replacing processed food.     The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic     health in children as measured by glucose tolerance, lipid metabolism and inflammatory     markers.   "
96280|NCT02025920|"     It has previously been observed that increased fish intake improves the metabolic health of     overweight and obese adults, and animal protein improved metabolic health of obese rats. In     this project the investigators will investigate whether increased intake of fish or meat     improves metabolic health in overweight/obese adults aged 20-55 years when replacing     processed food. The hypothesis is that increased intake of unprocessed fish or meat will     improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and     inflammatory markers.   "
96281|NCT02025907|"     The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to     placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have     inadequate glycemic control on maximally or near-maximally effective doses of metformin and     sitagliptin.   "
96282|NCT02025894|"     The purpose of this study is to identify risk factors for thromboembolic and /or infectious     complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous     Catheter (PCVC). A better understanding of the risk factors for these complications in this     population would then allow interventional studies to be proposed to assess the benefit of     prophylactic procedures in a sub-group of patients at most risk.   "
96283|NCT02025881|"     The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a     phase II trial, and ii) a dose-finding part.      The Phase II trial is an open label, non-randomized, multicentre trial without control group.     A Bayesian approach will be used to analyse the EFS, assuming a cure model. We will use three     prior distributions of the EFS; (1) an enthusiastic prior distribution, (2) a pessimistic     prior distribution, and (3) a non-informative prior distribution. As the patient outcomes in     the trial will be recorded, the subsequent distribution of the outcome probability under     experimental treatment will be computed by applying Bayes' theorem, which yields an estimated     EFS probability with a 95% credibility interval (measure of Bayesian precision). Two interim     analyses are planned to monitor the efficacy data (early stopping rules for futility or     inefficacy).      The final analysis of efficacy will be made on an intention to treat basis, including all     recruited patients, 3 years after recruitment of the last patient.      Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with     Busilvex for the last chemotherapy course in patients in complete response after     intensification chemotherapy treatment, a dose-finding subtrial will be performed to address     this issue (Phase I part). The dose escalation of cyclophosphamide will be performed using     the Continual Reassessment Method in a Bayesian framework.   "
96284|NCT02025868|"     Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire,     Mali and Senegal, West Africa.      HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be     recruited and followed in two phases:        -  First, a 12-week intentive adherence reinforcement phase, during which patients will          continue 2nd-line ART, be seen repeatidly for counseling and educational training on          adherence, and be offered the possibility of phone, SMS and home visit contacts with          social workers;        -  Second, a 48-week phase, during which:             -  Patients successfully resuppressed at the end of the first phase will continue               2nd-line ART and adherence reinforcement;             -  Patients with persitent virologic failure will switch to a darunavir/r +               raltegravir-based 3rd-line ART.      Genotype resistance tests will be performed retrospectively on frozen samples. The main     outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64     weeks.   "
96300|NCT02025660|"     Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is     likely to increase survival in patients with severe sepsis.      Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving     survival and the recovery of organ function in patients with severe sepsis. This will be     assessed with the help of the following        -  Mortality in the two arms        -  Daily SOFA scores        -  Ventilator free days        -  Time-to-vasopressor withdrawal        -  ICU length of stay        -  Hospital length of stay METHODS This will be a proof of the concept study to assess the          effect of Mycobacterium w in combination with standard therapy versus standard therapy          alone on the inflammatory profile in sepsis due to gram negative infection. A total of          25 patients will be enrolled in each group. The patients will be randomized in balance          to receive either test drug or its placebo along with the standard of care   "
96338|NCT02025166|"     To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following     surgical abortion.      The medication will be given at the time of the procedure. Following the abortion, pain level     will be evaluated.   "
96285|NCT02025855|"     The purpose of this study is to determine if administering methadone to mechanically     ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions     of sedatives and analgesics will decrease the time of mechanical ventilation, when initiated     within 48 hours of their admission. Patients meeting enrollment criteria will be randomly     assigned to receive methadone or placebo in addition to standard care. Methadone is a long     acting pain medication that is approved by the Food and Drug Administration (FDA) to manage     withdrawal from opioids and moderate to severe pain. Both of these indications are a frequent     concern for critically ill patients that require mechanical ventilation. These patients often     require intravenous (IV) opioids to manage the pain they experience due to their illness,     procedures, and mechanical ventilation. During this time patients can develop physical     dependence, which leads to withdrawal symptoms when the opioids are stopped or the dose is     reduced. These symptoms can include agitation, pain, diarrhea and several others. Currently     this is managed by a slow reduction in the dose of the IV opioid, but this can lead to     prolonged time on mechanical ventilation, which has been associated with increased morbidity.     Administering oral methadone to patients experiencing withdrawal symptoms has been shown to     reduce and even eliminate these symptoms in the outpatient setting. This should also benefit     patients in the ICU experiencing withdrawal from intravenous opioids required during their     stay. It may allow for the other opioids to be discontinued more quickly, allowing for a     shorter duration of mechanical ventilation.      The level of pain and sedation will be assessed between groups randomized to either methadone     or placebo in addition to current intravenous sedative and analgesic agents. The duration of     mechanical ventilation will be assessed between both groups. Opioid withdrawal symptoms may     manifest or be mistaken for delirium symptoms. ICU delirium is often managed with     antipsychotic medications. To assess if methadone can reduce the need for antipsychotic     medication, all administered antipsychotic doses will be recorded and total consumption will     be compared between the two groups. Methadone has been associated with abnormal heart rhythms     in rare instances. To ensure patient safety, data from the heart monitor will be collected     and compared between the two groups to assess for QT interval prolongation.   "
96286|NCT02025842|"     To evaluate the impact of liver fibrosis and other variables [e.g., age, sex, virological     response (VR), and previous resistance to nucleoside/nucleotide analogue (NUC) therapy] on     Hepatocellular carcinoma incidence in an Italian population of genotype D HBeAg-negative CHB     patients treated with long-term NUC therapy.   "
96287|NCT02025829|"     The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs)     are central to the disease pathology in CF. This will be determined by demonstrating that     IL-17 PMNs are present in the CF airway, correlate with lung function measures, and decrease     in patients being treated with IV antibiotics for a pulmonary exacerbation.   "
96288|NCT02025816|"     Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents     of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these     devastating infections      Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be     used for standard clinical analysis of bacterial species present or stored for later RNA     sequencing. RNA sequencing will identify bacteria that are present within the infection site     that may not be detected using standard culture techniques as well as reveal bacterial gene     expression profiles within the NSTI site. Medical charts will also be reviewed for basic     patient information as well as wound care management practices. We hope to identify bacterial     species commonly present in these types of infections as well as risk factors predisposing     individuals to NSTI's.   "
96289|NCT02025803|"     The purpose of this exploratory study is to investigate the safety and determine the maximum     tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced     solid tumors for which the patients have no available therapy likely to convey clinical     benefit.   "
96290|NCT02025790|"     The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of     achalasia cardia.   "
96291|NCT02025777|"     Study Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of     the colon mucosa in UC Disease patients. This study is designed to evaluate the yield and     clinical impact of IBD capsule in detecting lesions associated with UC Disease and to     determine the agreement between PillCam Platform with the IBD capsule and optical colonoscopy     in the evaluation of UC disease extent.      Primary Scientific Objective To evaluate the agreement between PillCam IBD system and optical     colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis, Left-sided     colitis, Pancolitis)      Proposed Design Established UC disease patients whose clinical condition suggests ongoing     disease activity, aged 18 years and up, who have no evidence of symptomatic stricture or     other obstruction that would prevent capsule passage will be enrolled in this study.      Patients will undergo bowel prep, followed by a PillCam IBD capsule examination and     colonoscopy examination.      The Rapid videos will be evaluated by two readers, each from a different site, the     colonoscopy videos will be evaluated by two other physicians, at the sites      INCLUSION CRITERIA      All subjects must fulfill all of the following inclusion criteria:        -  Patients ages 18 years and up        -  Patient has known UC according to physician discretion        -  Patient has at least one positive inflammatory marker from the following:             -  ESR             -  CRP             -  CBC        -  Patient is indicated and eligible for a standard of care colonoscopy examination        -  Patient agrees to sign consent form      EXCLUSION CRITERIA      The presence of any of the following will exclude a patient from study enrollment:        -  Crohn's Disease        -  Antibiotic Associated Colitis        -  Stool positive for O&P (C&S within 3 months of enrollment)        -  Other known infectious cause of increased symptoms        -  Known intestinal obstruction or current obstructive symptoms, such as severe abdominal          pain with accompanying nausea or vomiting.        -  Definite long stricture seen on radiological exam.        -  Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during          the 4 weeks preceding enrollment        -  Suspected GI stricture, followed by patency capsule study or other imaging study that          could not prove patency of the GI tract.        -  Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6          months, other than uncomplicated procedures that would be unlikely to lead to bowel          obstruction based on the clinical judgment of the investigator.        -  Patient is expected to undergo MRI examination within 7 days after ingestion of the          capsule.        -  Patient with known gastrointestinal motility disorders.        -  Subjects with known or suspected delayed gastric emptying        -  Patient suffers from any condition, such as swallowing problems, which precludes          compliance with study and/or device instructions.        -  Patient has Type 1 or Type II Diabetes.        -  Patient has any allergy or other known contraindication to the medications used in the          study.        -  Patient has any condition, which precludes compliance with study and/or device          instructions.        -  Women who are either pregnant or nursing at the time of screening, or are of          child-bearing potential and do not practice medically acceptable methods of          contraception.        -  Concurrent participation in another clinical trial using any investigational drug or          device.        -  Patient suffers from a life threatening condition        -  Patients with history or clinical evidence of renal disease and/or previous clinically          significant laboratory abnormalities of renal function parameters.   "
96292|NCT02025764|"     The prophylactic APC right after colonic EMR doesn't mean the complete coagulation of visible     vessel because of injection material.      The aim of this study was to evaluate the clinical feature of the visible vessels in ulcer     base over time after prophylactic APC in colonic EMR.   "
96293|NCT02025751|"     The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray     compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.   "
96294|NCT02025738|"     Data on the perioperative management of patients cardiac implantable electronic devices     (CIEDs) is limited and published guidelines rely mainly on the experience of the     cardiologists and anesthesiologists who manage these patients. Depending on the device type     and patient's dependency, these guidelines recommend the intraoperative magnet use,     reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable     method) has become the standard approach in many centers, while CIED reprograming by trained     personnel is required in most centers. Therefore, our objective is to compare in a     prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS     reprogramming vs. no intervention (in the appropriate subjects)   "
96295|NCT02025725|"     The purpose of this study is provide confirmation of the safety and efficacy of     Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic     gastroparesis in adult women.   "
96296|NCT02025712|"     The purpose of this study is to determine whether exemestane plus everolimus are effective in     the treatment of patients who have achieved disease stabilization after induction     chemotherapy for hormone-receptor positive metastatic breast cancer.   "
96297|NCT02025699|"     The TAILORED-Treatment consortium was established to develop new tools aimed to increase the     effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the     emergence of antimicrobial resistance in children and adults.   "
96298|NCT02025686|"     The hypothesis of this investigation is to observe if HBO have an anti-inflammatory effect in     humans induced by tonic heat stimulation. It has been shown in animal studies with rats that     HBO could reduce the paw edema induced by carrageenan as an inflammatory agent. The authors     are not aware of similar studies in human subjects investigating this effect of HBO. Aim: To     investigate the anti-inflammatory effect of HBO by reducing the hyperalgesia induced by heat     stimulation in healthy subjects and promote future research and understanding of the     anti-inflammatory processes in humans. The primary endpoint is a reduced area of secondary     hyperalgesia after HBO.   "
96299|NCT02025673|"     Betatrophin is a newly identified hormone that promotes pancreatic beta cell proliferation,     improves glucose tolerance and regulates lipids metabolism. A recent study showed that     circulating concentrations of betatrophin doubled in type 1 diabetes. The objective of this     study is to investigate the association of serum betatrophin levels with the progression of     diabetic retinopathy in patients with type 2 diabetes and the level of betatrophin in     gestational diabetes patients and pregnant women.   "
96416|NCT02024152|"     This study is to investigate the pharmacokinetics (PK) together with the safety and     tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in     comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in     healthy male and female volunteers after a single dose administration.   "
96302|NCT02025634|"     The purpose of this randomized, placebo controlled, single blind study is to determine if     postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are     reduced with the administration of IV acetaminophen when compared to a control group.     Particular focus will be on the postoperative opioid consumption. In addition, we will     ascertain if the total time the participant is in the PACU differs in those who receive the     IV acetaminophen versus those who do not.   "
96303|NCT02025621|"     A study to evaluate levosimendan compared with placebo in reducing the composite event rate     of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist     (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on     cardiopulmonary bypass (CPB).   "
96304|NCT02025608|"     The purpose of this study is to explore whether patients with restless legs syndrome (RLS)     differ from healthy subjects in daytime and night time autonomic function and cardiovascular     risk markers and whether 4 week treatment with pramipexole affects autonomic function and     cardiovascular risk markers in patients with RLS.   "
96305|NCT02025595|"     The aim of this study is to investigate the effects of genetic and environmental risk factors     on central nervous system (CNS) reward and satiety circuits in the etiology of obesity. The     investigators will also investigate to what extent the alterations in CNS reward and satiety     circuits are a cause or a consequence of the development of obesity.   "
96306|NCT02025582|"     Idiopathic Toe Walking (ITW) is a diagnosis normally of exclusion and likely, consequently,     is approached in vastly varying ways of intervention, including serial casting, Botox     injections and physical therapy. There is some evidence in the literature that children with     ITW can somewhat correct their lack of heel-strike gait pattern at least temporarily. Kinesio     Taping (KT) method is an intervention that is used in the outpatient physical therapy setting     for various conditions such as post-operative edema, muscle facilitation of weakened rotator     cuff muscles, and functional corrections in children with torticollis. This pilot study will     strive to determine if KT may be effective by providing proprioceptive and neuromuscular     re-education through thermal and mechanical fascial impositions, thereby improving passive     joint range of motion (ROM) through reduction of passive muscle stiffness and improving     ambulation through neuromuscular re-education in children with idiopathic toe walking. We     will quantify passive muscle stiffness of the gastrocnemius and opposing anterior tibialis     using non-invasive Shear Wave Elastography (SWE). Further we look at the kinematics and     kinetics of the child's ankle during the gait cycle to further determine any effect(s) of KT     on functional walking outcome measures. The intent is that the results from this study will     serve as a platform from which to expound look at the long-term, if any, effects of KT on the     muscle property and gait cycle pattern in children with ITW.   "
96307|NCT02025569|"     This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of     chronic ankle instability.   "
96308|NCT02025556|"     The purpose of this study is to determine whether monthly subcutaneous administration of     LBR-101 is safe and provides migraine prevention in subjects with high frequency episodic     migraine.   "
96309|NCT02025543|"     The purpose of this multi-site research is to validate a rapid magnetic resonance based     confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron     concentrations.   "
96310|NCT02025530|"     The United Kingdom has one of the highest rates of stillbirth in Europe, with more than 4,000     stillbirths every year; which equates to more than 11 deaths every day. Furthermore, this     rate has changed very little over the last 20 years. This loss of life and the adverse     psychological consequences urgently needs addressing.      A recent New Zealand study investigating modifiable factors associated with stillbirth (the     Auckland Stillbirth Study) found that mothers who did not go to sleep on their left side had     a twofold risk of late stillbirth (≥28 weeks gestation) compared to mothers who did go to     sleep on their left side. These novel findings need urgent confirmation.      This proposed study aims to confirm or refute these findings and to ascertain whether a     preventative programme should be introduced. This proposed study aims to confirm or refute     the findings of the Auckland Stillbirth Study.      Participants will be recruited from maternity units in the Midlands and North of England (led     by centres in Liverpool, Manchester, West Yorkshire and Birmingham). 291 women with a     singleton late stillbirth without congenital abnormality will be interviewed by research     midwives shortly after the birth. A control group of 580 women with ongoing pregnancies will     be interviewed at a gestation group matched to that at which stillbirths occurred. These data     will determine whether an intervention study should be considered. If there is a causal     relationship between maternal sleep position and late stillbirth we estimate that upto 37% of     late stillbirths might be prevented.   "
96311|NCT02025517|"     Treadmill gait training combined with cognitive tasks in Parkinson's disease.   "
96312|NCT02025504|"     Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete     colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due     to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such     obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and     impact patient experience and tolerance. The investigators propose to evaluate the efficacy     of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance     of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants     undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for     the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be     performed per usual operating procedures. The primary outcome will be time to distal extent     (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of     ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator     and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise     comparisons between groups with respect to primary and secondary outcomes.   "
96339|NCT02025153|"     To determine whether central sensitization is a mechanism of CPSP (chronic postsurgical pain)     in women who will develop CPSP compared to women with no CPSP after hysterectomy. This     mechanism is illustrated by a higher pain score in experimental pain models such as tonic     heat stimulation, increased evoked mechanical temporal summation and increased wound     hyperalgesia.   "
96313|NCT02025491|"     Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with     increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular     and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of     lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40%     of the cases.      DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been     documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte     de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of     high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to     relevant drug toxicity, high morbidity due to a long lasting disease, with an important     socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate     than historic cure rates of pentavalent antimony in the treatment of disseminated     leishmaniasis.   "
96314|NCT02025478|"     The investigators hypothesize that children receiving human milk will maintain a greater     diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in     the blood compared with children not receiving human milk.   "
96315|NCT02025465|"     Atrial Fibrillation and atrial flutter (AF/FL) is the usually irregular beating of the heart     and is a rapidly growing cause of hospitalization. Between 1993 to 2007 AF/FL     hospitalizations have increased 203% compared to a 71% increase for all hospitalizations.     Changing procedure management such as ablation, transesophageal have had a minimal impact on     the trends and there is a need to evaluate Emergency Department (ED) management options of     AF/FL that may decrease hospitalizations.      The most commonly used medications to control heart rate are metoprolol (MET), a beta     blocker, or diltiazem (DT), a calcium channel blocker. Beta blockers are medications that     cause the heart to beat more slowly and with less force. DT also helps blood vessels open up     to improve blood flow. Both DT and MET are used alone or together with other medicines to     treat severe chest pain (angina), high blood pressure (hypertension) or rapid heartbeat. Both     are equally acceptable according to recent guidelines for AF/FL. There are limited studies     comparing MET to DT for rate control for AF/FL.      The initial goal for AF/FL management in the Emergency Department is usually rate control.      The most commonly used rate control medications are metoprolol (MET), a beta blocker, or     diltiazem (DT) a calcium blocker. Three major guidelines, including the American College of     Cardiology (ACC) and the American Heart Association (AHA) indicate beta blockers and DT are     equally acceptable medications for rate control in AF (3,4,5) assuming no contraindications.      There are limited studies comparing beta blockers (BB) to DT for rate control for AF:        1. Demircan, et. al., compared bolus intravenous BB and DT in 40 patients over a 20 minute          period. No follow-up information after 20 minutes was reported. No attempt was made to          look at intermediate or long term results. No patients converted to normal sinus rhythm          over this short treatment period and there was slightly more rate decrease at 20          minutes, with DT versus BB (6).        2. Time from medication administration to heart rate and rhythm control. Additionally,          currently guidelines consider BB or DT medications to slow AF/FL; however, there are          some suggestions that BB may not only slow heart rate in AF/FL (as does DT) but also          increase all AF/FL conversion from AF/FL to normal sinus rhythm(2), and aid in          maintaining normal sinus rhythm (NSR) after cardioversion (10). With recent onset AF/FL          occurring within 48 hours prior to the arrival to the ED, approximately 50% of AF/FL          patients convert to normal rhythm spontaneously within 24 hours after arrival to the ED          (6), making evaluation of current limited studies difficult. Thus, the investigators          wish to examine the effect of initial medication strategy on time to NSR in a larger          sample than has been previously performed.        3. A randomized study of 48 patients in China reported significantly slower heart rate up          to 20 minutes with DT 10mg IV versus metoprolol 5mg IV but not after 30 minutes (7).        4. A retrospective study of post-operative coronary bypass patients showed the intravenous          administration of the BB, esmolol, to be more effective than DT for rate control and          conversion of AF/FL (8).        5. Hassan et al reported no difference in conversion to regular rhythm with esmolol verses          DT in a small, under powered, randomized study of fifty ED patients (9). Conversion to          sinus rhythm occurred in 10 patients (42%) in the DT group compared with 10 patients          (39%) in the esmolol group (P = 1.0). There were no statistically significant          differences in heart rate between the two medications at 1, 6, 12, and 24 hours after          initiation of esmolol or DT infusion.      Examples of such well quoted strategy trials are the COURAGE trial published in the New     England Journal of Medicine and the PROMISE Trial, a worldwide multi-centered study that is     nearing completion goal of 10,000 patients of which, Charleston Area Medical Center (CAMC)     has enrolled approximately 100 patients. In this trial, patients being evaluated for chest     pain will be randomized to two treatment strategies and subsequent outcomes will be recorded.      Strategy trials do not attempt to manage treatment after an initial management strategy has     been determined by randomization, but, whether the initial treatment affects long-term     outcomes.      This will be a prospective, randomized study comparing the outcomes of a strategy using     either MET or DT in patients with AF presenting to the Charleston Area Medical Center (CAMC)     ED. After presentation and receiving consent, the patient will be randomized to receive     either MET or DT.   "
96316|NCT02025452|"     Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have     viral gastroenteritis and so not treated with antibiotics - but they may indeed have a     treatable cause for their illness. We will conduct a randomized trial to see if rapid testing     using novel methods to identify potentially treatable causes of diarrhoea leads to improved     outcomes. We will also be randomizing children to probiotic therapy versus placebo (the     standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed     study is a pilot trial, necessary before embarking on a large multi-centre trial.   "
96317|NCT02025439|"     The purpose of this study is to examine the safety and efficacy of repetitive transcranial     magnetic stimulation (rTMS) combined with Amantadine relative to rTMS Alone and Amantadine     Alone for persons in chronic states of seriously impaired consciousness. The hypothesis is     that provision of rTMS+Amantadine will provide a safe yet synergistic effect that induces or     accelerates functional recovery.   "
96318|NCT02025426|"     Phenylephrine administration is associated with reductions in CO and SctO2 compared with     ephedrine when used for blood pressure management in women with pre-eclampsia undergoing     cesarean delivery under spinal anesthesia.   "
96319|NCT02025413|"     The primary objective of the preliminary lead-in study is to determine whether circulating     tumor cells in patients with metastatic progressive castration-resistant prostate cancer or     metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based     ferrofluid (N-cadherin or O-cadherin based).      The primary objective of each comparative cohort (second stage, prostate cancer) is to     compare the non-detection rate of circulating tumor cells between the standard and novel     methods.   "
96320|NCT02025400|"     The investigators have previously reported on patient utilization of an eRehab patient     education web portal that utilizes streaming, clinician prescribed video instruction to     motivate and inform patients in self-care of their orthopedic condition, focusing on the     importance of a home exercise program. The greatest barrier to patient use of this web-based     home exercise treatment plan was the initial access to the program. The purpose of this study     is to compare an Internet-based patient education rehab portal (eRehab) to formal physical     therapy (PT) in terms of patient costs and outcomes.   "
96321|NCT02025387|"     Examine whether the measurement and feedback of physical activity increase the physical     activity in women who underwent midline incision, gynecological surgery   "
96322|NCT02025374|"     Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with     hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for     analgesics in patients undergoing elective cesarean section. Our hypothesis is that     hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic     conditions compared to hyperbaric bupivacaine.   "
96323|NCT02025361|"     Transrectal ultrasound guided prostate biopsy (TRUS-Bx) is the gold standard method for     prostat cancer diagnosis. Cancer detection rate is an important issue in TRUS-Bx. Effective     biopsy protocol is necessary to enhance cancer detection rate during the procedure. Patient     tolerance may improve the protocol effectiveness and quality.      Adequate patient tolerance with optimal local anesthesia may enhance cancer detection rate in     TRUS-Bx.   "
96324|NCT02025348|"     This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.      The study will characterise the performance of IntelliCap® by evaluating the plasma     concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from     IntelliCap® with three different release profiles and the plasma concentration and     pharmacokinetic profile of the same probe drug after a single dose of an oral solution.   "
96325|NCT02025335|"     CMV is one of the most important opportunistic infection in transplant recipients. In South     Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity     for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the     risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific     cell-mediate immune response before solid organ transplantation will further categorize the     patients into high or low risk of CMV development after solid organ transplantation. The     investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant     candidates to predict the development of CMV infection after kidney transplantation.   "
96326|NCT02025322|"     This study aims to investigate the effectiveness of an in-person peer mentoring and health     literacy intervention on improving medication adherence, HIV-1 viral load, CD4+ T lymphocyte     counts, and HIV medical appointment attendance among newly-diagnosed and/or medication     non-adherent HIV-positive individuals, compared to standard of care provider/staff-delivered     education.   "
96350|NCT02025010|"     This study is comparing the safety and effectiveness of abiraterone acetate alone, followed     by the addition of prednisone (when the participant's disease worsens or the physician feels     it would lessen symptoms of toxicity) versus the current approved treatment regimen which     involves the concomitant use of prednisone in conjunction with abiraterone acetate.     Additionally, this study is also examining why participants stop responding to treatment with     abiraterone acetate by evaluating blood and tissue.   "
96327|NCT02025309|"     Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the     effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its     activity by encapsulating these. Likewise, some other steroid hormones and drugs like     flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that     methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in     this study we aimed to compare the recovery times from recuronium-induced muscle relaxation     after reversal with sugammadex between patients who receive intraoperative methylprednisolone     or not.      After institutional review board (IRB) approval and informed consent, 100 patients will be     enrolled in this prospective, single center, controlled study. Anaesthesia will be induced     with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance.     Patients will be divided into two groups (Group M, n: 53 and group C, n: 47,     methylprednisolone administered group and control group respectively) according to the     requirement of methylprednisolone administration which is dictated by the type of the     surgical procedure. Neuromuscular blockade will be monitored using calibrated train-of-four     (TOF-Carescape B 650 NMT, GE, Connecticut, USA). Once rocuronium-induced neuromuscular     blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of     sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9     at the ulnar nerve. The time to recovery of TOF to 0.7 and 0.9 will be compared in both     groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U     test.   "
96328|NCT02025296|"     Recently, we generated a new multidisciplinary ubiquitous healthcare system by upgrading our     clinical decision supporting system (CDSS) rule engine, and integrating a physical     activity-monitoring device and dietary feedback into a comprehensive package. We hypothesize     that individualized multidisciplinary u-healthcare service combined with exercise monitoring     and dietary feedback will result in better glucose control with less hypoglycemia in an     elderly population.   "
96329|NCT02025283|"     The aim of this study is to compare early and long term efficacy of lumbar radiofrequency     nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed     previous conventional therapy. Medical records of 37 patients undergoing targeted disc     decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were retrospectively     examined.Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Functional Rating Index,     Backache index, Oswestry Lumbar Back Pain Disability Index, Rolland-Morris Lumbar Back Pain     Questionnaire scales were used before treatment and 1,6,12 months after the procedure. North     American Spine Society Satisfaction Scale was used at 12th month after the procedure.   "
96330|NCT02025270|"     In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic     patients in a trial to enhance and activate the spermatogonial stem cells of the testis and     aiming to produce motile sperm.   "
96331|NCT02025257|"     The purpose of this study is to investigate the effects of exercise for patients with     coronary artery disease (CAD) aged 80 years and older, with special reference to maximum     aerobic capacity, muscle endurance, physical functioning, level of physical activity, health     related quality of life, anxiety, depression and endothelial function, compared to a control     group.   "
96332|NCT02025244|"     Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of     esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner     surface. The prognosis and treatment of these tumors depend on their correct diagnostics and     mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps biopsy     of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching deeper     layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the diagnostics     of Upper gastrointestinal Submucosal Tumors.   "
96333|NCT02025231|"     The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to     patients with recurrent high-grade glioma who have previously received radiotherapy and to     determine the best dose and treatment regimen. Positron emission tomography (PET) using an     amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The     study examines, in four sequential treatment groups, the effect of dose, hypofractionation     and treatment volume on toxicity. Upon completion of the phase I part, the study progresses     to phase II where the best dose- and treatment regimen will be chosen for treatment.   "
96334|NCT02025218|"     To evaluate the effect of re-administration of gefitinib to EGFR-mutated NSCLC patients who     had been treated with at least one line of TKIs followed by another line of treatment     (non-TKI)   "
96335|NCT02025205|"     The aim of this prospective, randomized, controlled, one-way crossover study is to assess and     compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in     patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12     months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm     after the 6-month visit and will be followed up for 6 additional months.The primary objective     is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary     objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index)     changes, target lobe volume reduction, as well as safety outcomes.   "
96336|NCT02025192|"     The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended     phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of     tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both     capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.   "
96337|NCT02025179|"     This extension study will only enroll individuals who have completed one year of treatment in     the parent protocol Effect of Teriparatide, Vibration and the Combination on Bone Mass and     Bone Architecture in Chronic Spinal Cord Injury (NCT01225055). This study will allow those     individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent     study to be treated for a second year and will allow those individuals who received     teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy.     This study will determine if two years of exposure to teriparatide will result in a greater     increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects     will be evaluated at 6 and 12 months after initiating treatment with measurement of bone     density as well as bone markers of formation and resorption.   "
96340|NCT02025140|"     • Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness     of pain control in children can be influenced by child characteristics .      Objectives: The Purpose of the study is to compare the pain perception and the effectiveness     of anesthesia between the computer-controlled local anesthetic delivery system (CCLAD) and     the traditional inferior alveolar nerve block (IANB) in pulptomies of the mandibular second     primary molars.      Materials and Methodology: The study sample includes 90 healthy children who are selected     randomly from the R4 electronic filing system in King Abdulaziz University Hospital (KAUH)     with age range from 5-9 years. The child is required local anesthesia for pulpotomies in the     mandibular second molars. The sample will be divided randomly to one of these 3 groups: group     A is composed of 30 patients who will be anesthetized by the traditional IANB. Group B     includes 30 patients will be anesthetized by the IANB using CCLAD. While, the remaining 30     patients will be assigned in group C and will be anesthetized by periodontal ligament     injection anesthesia using the CCLAD. The pain perception levels after the injection is     assessed by a Wing-Baker faces pain scale. Effectiveness of the anesthesia during each step     in pulpotomy is measured using Sounds, eyes and motor (SEM) scale. After the treatment by 24     hours parents will be contacted by the telephone to ask about the presence of postoperative     pain or lip biting. Statistical analysis is carried out using SPSS version 16.00.   "
96341|NCT02025127|"     Septic shock represents the body's dysregulated response to an infection, manifesting as     persistent hypotension (mean arterial pressure < 70 mmHg) despite intravenous (IV) fluid     resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting     millions of people around the world each year In critically ill patients without shock,     provision of enteral nutrition within 24-48 hours has shown to preserve intestinal     epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance     immune function, and preservation of tight cell junctions to reduce permeability. These     benefits of enteral nutrition are postulated to prevent downstream complications of     nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data     addressing this question are lacking.      There is a paucity of data on the timing and role of enteral nutrition in septic shock.      Specific aim 1: To examine the effect of enteral nutrition of >50 kcal/day but <600 kcal/day     compared to no enteral nutrition initiated with 24 hours of admission on the number of     intensive care unit free days' in patients with septic shock.      Hypothesis 1: The investigators hypothesize that amongst mechanically ventilated patients     with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day     but <600 kcal/day, as compared to no enteral nutrition, improves the primary outcome of     number of intensive care unit free days'.      Specific aim 2: To examine the effect of enteral nutrition of >50 kcal/day but< 600 kcal/day     initiated with 24 hours of admission on in-hospital mortality, mechanical ventilator free     days, time to 50% reduction in vasopressor dose, and time to initiation of physical therapy     in patients with septic shock.      Hypothesis 2: The investigators hypothesize that amongst mechanically ventilated patients     with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day     but <600 kcal/day, as compared to no enteral nutrition, decreases mortality, duration of     mechanical ventilation, time to 50% reduction in vasopressor dose, and time to initiation of     physical therapy.   "
96342|NCT02025114|"     This is an open-label, non-randomized, multicenter phase Ib/II study, which is composed of a     phase Ib dose escalation part and a phase II dose expansion part. Patients will receive     selumetinib in combination with gefitinib 250mg daily. This study will enroll EGFR-mutated     NSCLC patients who have developed acquired resistance to EGFR TKI treatment.   "
96343|NCT02025101|"     Description of the phenomena Slow Coronary Flow (SCF), according to the data that has been     collected from patients hospitalized with specific criteria. Clinical follow-up of these     patients to determine whether they suffered from any cardial or psychological disorders that     might be a result of SCF.   "
96344|NCT02025088|"     Acne scars have high prevalence, significant impact on quality of life and are a therapeutic     challenge for dermatologists. Previous studies have shown promising results for the treatment     of acne scars with non-ablative fractional laser and microneedling, however there are no     studies comparing the these techniques. Therefore, the objective of this study is to compare     the effectiveness of treatment of atrophic acne scars on the face with non-ablative     fractional erbium laser and microneedling.   "
96345|NCT02025075|"     The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on     global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic     surgery. Furthermore, we will investigate if the level of NMB influences intraoperative     hemodynamic and cerebral oxygenation.   "
96346|NCT02025062|"     The intervention tested in this research project aims to reduce this inequality by improving     the management of elderly head and neck cancer patients with a specific management. Indeed,     the treatment of elderly head and neck cancer patients has specificities concerning treatment     options, their tolerance, psychological management, nutritional and functional status, and     support needed at home. To assess the overall needs of the elderly patients, an assessment     known as comprehensive geriatric assessment (CGA) can be performed by a geriatrician with     extensive testing and questionnaires. This assessment is long and requires an experienced     geriatrician. It leads to the development of an individualized treatment plan (physiotherapy,     psychological follow-up, support at home, nutritional management ...) and follow-up to adapt     the necessary cares for the duration of the cancer treatment. The CGA utility has been     studied in elderly patients with nonmalignant diseases. Studies have shown that CGA allowed     improving survival and maintaining the elderly at home.   "
96347|NCT02025049|"     Inflammation of the pancreas often leads to severe damage not only to the pancreas but also     to other organs in the abdomen as well as to complications in organs further away like the     lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe     inflammation of the pancreas, can mitigate the development of processes that can lead to     serious complications of this disease.   "
96348|NCT02025036|"     A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with     cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But     in China because of its toxic reaction, most of patients stop the halfway. Because low     toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely     used in clinical.      The purpose of this study is to confirm the difference of Capecitabine plus with or without     oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for     esophagus squamous cell carcinoma. A total of 630 patients will be accrued from China within     2 years. The primary endpoint is overall survival and the secondary endpoints include     progression-free survival, response rate, pathologic complete response rate and adverse     events.   "
96349|NCT02025023|"     Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection     of triamcinolone (steroid) and incision and curettage for treatment of chalazia.   "
96417|NCT02024139|"     This study investigates whether chewing sugar-free chewing gum can reduce pain associated     with braces treatment. The study collects pain scale records for 10 consecutive days after     placement of braces. No changes to patients routine braces treatment is done. All materials     used are available over the counter.   "
96351|NCT02024997|"     The overall aim of this study is to investigate a novel dual instance planning method to     make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment     planning.      Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and     expiration (EXP) positions and characterize the changes in geometric relationships between     the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and     bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification     of patients who may benefit from the dual instance planning method.      Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single     instance breath hold, and the novel dual instance anatomical information. We hypothesize that     use of the dual instance method will lead to improved plans, demonstrated by the ability to     increase dose to the target, while maintaining the clinically-accepted normal tissue dose     constraints.   "
96352|NCT02024984|"     INTRODUCTION Polycystic ovary syndrome (PCOS) is one of the most common female endocrine     disorders (Fauser et al., 2011). It is a complex, heterogeneous disorder of uncertain     aetiology, but there is strong evidence that it can, to a large degree, be classified as a     genetic disease (Fauser et al., 2011). Genetic and environmental contributors to hormonal     disturbances combine with other factors, including obesity (Diamanti-Kandarakis et al.,     2006). Ovarian dysfunction and hypothalamic pituitary abnormalities contribute to the     etiology of PCOS (Doi et al., 2005).      It produces symptoms in approximately 5% to 10% of women of reproductive age (12-45 years     old). It is thought to be one of the leading causes of female subfertility (Goldenberg and     Glueck, 2008).      Its prevalence has increased with the use of different diagnostic criteria and has recently     been shown to be 18% (17.8 ± 2.8%) in the first community-based prevalence study based on     current Rotterdam diagnostic criteria (March et al., 2010).      AIM OF THE WORK The study will compare the luteal phase (early) administration of clomiphene     citrate to the conventional (late) administration of the same drug in the follicular phase as     regards ovarian response in PCOS.      Research Question What is the difference between administration of clomiphene citrate in the     luteal phase and the follicular phase for ovulation induction in women with PCOS? Research     Hypothesis Luteal phase administration of clomiphene citrate protocol gives better results     than conventional administration of clomiphene citrate in the follicular phase as regards     ovarian response in PCOS.   "
96353|NCT02024971|"     The purpose of this study is to investigate the safety and efficacy of long-term use of     pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in     patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride     combined with metformin hydrochloride is considered suitable.   "
96354|NCT02024958|"     Energy expenditure (EE) in critically ill patients is highly variable depending on the     initial severity of the disease and treatments. Clinicians need to measure EE by indirect     calorimetry (IC) to optimize nutritional support. IC devices available on the market have     insufficient accuracy for clinical and research use. A new IC is being developed to meet     these needs.      Objectives: Validation of a reliable and easy-to-use IC device.      Primary objective:      • Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC     devices in intubated ICU patients on mechanical ventilation      Secondary objectives:        -  Accuracy of EE measurements in ICU patients of spontaneous breathing        -  Accuracy of EE measurement during ~30 min. vs. the sum of 6 periods of 60 min/12 hrs        -  Accuracy of EE measurements in ICU patients on non-invasive mechanical ventilation      Design: Prospective, controlled, observational multicenter study.      Subjects: 182 ICU patients.   "
96355|NCT02024945|"     The purposes of this study were to assess Quality of Life (QoL) and urination urge,     incontinence, and micturition frequency including nocturia after 4 and 12 weeks treatment     with propiverine.   "
96356|NCT02024932|"     The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh     muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).   "
96357|NCT02024919|"     Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of     epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE     constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in which     coronary artery stenosis or severe valvular heart diseases are not present. CAE represents     not only an anatomical variant but also a clinical constellation of coronary artery disease     (CAD) like association with myocardial ischemia and acute coronary syndromes. Patients with     CAE without significant coronary narrowing may still present with angina pectoris, positive     stress tests, or acute coronary syndromes. Impaired epicardial and microvascular perfusion     were demonstrated in ectatic coronary arteries.      Myocardial blush grading (MBG) technique has been utilized in various conditions such as     acute myocardial infarction, coronary artery ectasia, syndrome X and idiopathic dilated     cardiomyopathy to evaluate myocardial perfusion.      There is still no consensus for management of CAE. Previously improvement of coronary flow     has been demonstrated by mibefradil in patients with slow coronary flow. A new trial is     needed to explore the effect of calcium channel blockers (CCB) in isolated CAE. Diltiazem     improves myocardial perfusion by blocking calcium channels in coronary arteries. This agent     has been widely used in coronary catheter labs to prevent and treat no-reflow.      The current study with prospective design was therefore set up to assess whether epicardial     flow and tissue level perfusion would be improved by diltiazem in myocardial regions     subtended by the ectatic coronary arteries among patients with isolated CAE.   "
96358|NCT02024906|"     The purpose of this study is to help the researchers understand if using a soy supplement     impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.   "
96359|NCT02024893|"     -  Shoulder pain and dysfunction are common problems in overhead sports, due to extreme          ranges of motion and repetitive loading. Predisposing factors include inadequate range          of motion (ROM), such as a reduction in total ROM or a shift of balance between internal          and external rotation. Such a shift may be the result of soft tissue adaptations to the          activity demands, or reflect a structural outcome of Humeral retroversion. A shift in          the range of motion may be detrimental to the rotator muscle function, which may create          another risk factor for shoulder injury.        -  The purpose of this study is to document shoulder range of motion, humeral retroversion,          rotator muscle strength and fatigue in several groups of overhead athletes undergoing a          routine pre season screening once a year, and investigate the interaction between those          factors in the different groups.   "
96360|NCT02024880|"     In-vitro fertilization (IVF) treatment involves development of multiple follicles following     ovarian stimulation, oocyte retrieval and embryo transfer (ET). ET is the final and most     crucial step of IVF treatment.      The ET catheter has to pass through the endocervical canal to go into the uterine cavity     through the internal os. The endocervical canal may be filled up with mucus or blood. Embryos     trapped in the mucus or blood after the passage of the endocervical canal may not be able to     implant into the endometrium. Guardia™ Pro Protective ET catheter is designed to allow the     safe passage of embryos through cervical mucus and blood as its outer sheath protects the     embryo through entry and then opens in petals to further advance the inner catheter and     gently place the embryo.      The hypothesis of this study is that the pregnancy rate is significantly higher after ET     using protective ET catheters.   "
96361|NCT02024867|"     The objective of this study is to determine if there is a difference in treatment failures     and recurrent skin infections when patients are given 3 or 10 days of antibiotics for     uncomplicated skin abscesses after they have been surgically drained.   "
96362|NCT02024854|"     The aim of the study is to investigate physiological response, social/emotional response and     general movements in preterm infants when they are given skin-to-skin contact with the mother     (intervention) or standard care (incubator) right after delivery. Preterm infants will be     randomized to either intervention or standard care group. Data on body temperature, blood     glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the     infant will be video-recorded during the first 24 hours and at three months of age for     analysis of the general movements.   "
96363|NCT02024841|"     Phase I study on the maximum tolerated dose (MTD) and the recommended dose (RD) of     intraperitoneal docetaxel combined with intravenous cisplatin and oral TS-ONE in gastric     cancer patients with peritoneal carcinomatosis   "
96364|NCT02024828|"     The purpose of this study was to test the effect of four randomly assigned approaches to oral     feeding transition on feeding outcomes in preterm infants.   "
96365|NCT02024815|"     Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma     (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the     course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is     achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized     trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and     recalcification for patients with painful bone metastases from solid tumors. The role of     different palliative radiotherapeutic regimens for MM is not well established due to lack of     clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic     regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.   "
96366|NCT02024802|"     There has been a significant increase in the number of prescriptions being filled for Custom     Compounded Pain Creams. This study serves to evaluate the patient perception and satisfaction     with this type of pain therapy allowing us to identify any statistically relevant     relationships that may exist between this type of therapy and patient pain perception. A     secondary goal would be to identify any significantly relevant relationships that may exist     between this change in pain perception (if any) and the patients overall sense of well-being.     The investigators' null hypothesis is that greater that 85% of people will see an significant     decrease in perceived pain levels and greater than 85% increase in patient overall sense of     well being.   "
96367|NCT02024789|"     This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study     will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome.     Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally     twice daily for 26 weeks.   "
96368|NCT02024776|"     Despite recent advances, morbidity and mortality associated to major abdominal surgery is     significant. A poor physical condition and functional status reduces the ability of a person     to cope, mentally and physically, with hospitalization and surgery and may compromise     functional recovery, potentially leading to postoperative complications and death.     Prehabilitation aims to enhance functional capacity preoperatively for better toleration of     surgery and to facilitate recovery and eventually the prognosis of the surgical patient.     Whereas the benefits of cardiopulmonary fitness programs are well established, the     accessibility, sustainability of effects, and impact on the surgical outcome of these     programs are unsolved issues. Wellness programs based on integrated care services supported     by Information and Communication Technology (ICT) can overcome such limitations. The     investigators hypothesized that a prehabilitation program, inducing beneficial effects on     exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT     support may contribute to increase the adherence and sustainability of this intervention.   "
96369|NCT02024763|"     The aim of this study was to evaluate the impact of a classroom teachers' educational     intervention on 1st and 2nd grades children's physical activity level and energy expenditure     during physical education classes in elementary public schools, in São Paulo, Brazil.   "
96384|NCT02024568|"     Paclitaxel is chemotherapeutic agent used in many of the most common anti-cancer regimens.     Its use is frequently associated with moderate to severe muscle and joint pain that may     persist for several days after the treatment. This side effect, known as Arthralgia-Myalgia     Syndrome, has a significant impact on the quality of life and functional abilities of those     receiving the treatment, and is not alleviated by many of the interventions attempted for     that purpose.      Sporadic reports suggest that a drug called gabapentin may be effective in the management of     this adverse effect. Observations from our practice indicate that pregabalin, which possesses     similar biological activity to that of gabapentin, may also be useful in preventing and     treating paclitaxel associated myalgia - arthralgia.      The current study represents an initial evaluation of the hypothesis that pregabalin may be     beneficial in the management of the symptoms due to the Arthralgia-Myalgia Syndrome. The     investigation will be carried out in the format of a small scale, randomized, placebo     controlled trial with patients receiving paclitaxel in the course of standard treatment for     breast cancer.   "
96385|NCT02024555|"     The primary purpose of this study is to investigate the efficacy and safety of oral     antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We     suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic     pulmonary sarcoidosis participants.   "
96370|NCT02024750|"     Children with type 1 diabetes face complex self-management regimens which make adherence     challenging and ultimately result in poor blood sugar control. Several common barriers     interfere with diabetes control such as limited knowledge or challenges with staying     motivated. Efficacious strategies exist to improve diabetes self-management including, but     not limited to, diabetes education or family therapy. Patients and families often do not     access these strategies, in part due to healthcare systems-based issues such as     accessibility, provider availability, or insurance coverage.      A family-centered approach has been suggested to tailor diabetes care to provide improved     outcomes for each child. Family-centered care engages the family in the decision-making about     the child's health and well-being. In this study we will take a family-centered approach to     providing diabetes self-management by identifying families' unique self-management barriers     through a 10-minute survey tool called PRISM (Problem Recognition in Illness     Self-Management). Based upon the results of PRISM, we will provide tailored self-management     resources (interventions) to meet the family's needs. We will coordinate group-based delivery     of the resources with routine diabetes clinic visits. These group-based resources will be     delivered in four 75-minute sessions over a year.      The primary goal of this study is to compare the effectiveness of family-centered tailoring     of diabetes self-management resources with the untailored approach of usual care. We     hypothesize that the family-centered model of care with tailored resources will improve the     outcomes of glycemic control and quality of life among children with type 1 diabetes and     their parents.   "
96371|NCT02024737|"     Chronic Obstructive Pulmonary Disease (COPD) is a leading and still increasing cause of     disease and death worldwide, affecting those in both developed and developing countries. This     imparts a massive burden of ill health, in turn imposing huge healthcare costs to society.      For effective treatment of COPD (as opposed to providing short term relief) early disease     must be targeted. The small airways of the lung (those less than 2mm) are the first affected     in COPD, but current methods to assess their function are relatively insensitive. There is     therefore a need for new, accurate methods for detection of small airway dysfunction with     sensitivity to shortterm change and regional discrimination.      In previous studies with hyperpolarised (HP) 3He MRI in smokers with normal pirometry and     patients with early stage COPD, we showed sensitivity to early changes in lung ventilation     and structure. The hyperpolarised gas MRI technique is safe. In particular, the lack of     ionizing radiation permits patients to be imaged on multiple occasions. This and its inherent     sensitivity to regional lung ventilation and function make it an ideal imaging tool for the     assessment of novel lung therapies for diseases of the small airways.      The purpose of this pilot study is to determine short and long term reproducibility of a     comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI     and lung physiology measurements in patients with moderate to severe COPD.      In addition,how sensitive the imaging techniques are to changes in lung function after     treatment with a standard (bronchodilator) inhaler will also be assessed.      This pilot study will serve as a platform for future larger scale studies, aimed at better     understanding of and intervention in early COPD.   "
96372|NCT02024724|"     Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by     unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal     nerve. Current treatment strategies include oral medications as first line therapy with     surgical interventions reserved for those patients who are refractory to medications or     unable to tolerate medication side effects. Despite these current treatment options, many     patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine     adjustment of the needle tip and direct observation of the medicine.      Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic     nerve pain with great success. Steroids can be short or long acting in duration with varying     side effects. If there exists a difference in duration of action, using the longer acting     drug will provide a greater period of symptom relief for the patient and may allow the     patient to undergo fewer interventional procedures.   "
96373|NCT02024711|"     The purpose of this multicenter, prospective, randomized clinical study is to determine the     safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract     extraction and intraocular lens (IOL) implantation surgery.      EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal     endothelium and other intraocular tissues, and to manipulate tissues during surgery.      EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments     during cataract extraction and intraocular lens insertion.   "
96374|NCT02024698|"     The objective of this study is to compare the clinical performance of ProClear 1-Day versus     1-Day Acuvue Moist each for one week of daily disposable wear.   "
96375|NCT02024685|"     This is a psychosocial/behavioral study and does not involve administration of any treatment     or diagnostic procedures. We will use a randomized trial to test the hypothesis that a     decision analysis model that provides individualized estimates of quality-adjusted     disease-free survival for each of the treatment options for clinically localized prostate     cancer will lead to higher quality treatment decisions congruent with a patient's values     leading to improved decisional regret and treatment satisfaction. In this trial, all patients     would be evaluated at baseline for their utilities for various clinically important health     states. The control arm will receive counseling regarding treatment options using standard     patient-physician interactions and nomogram-predicted probabilities of treatment outcome for     the various treatment options and they will be unaware of the decision analysis     recommendation. The treatment arm would be counseled using standard patient-physician     interactions and they would also be provided with a personalized treatment recommendations     based on the decision analysis model prior to treatment selection. The primary endpoint of     this study will be regret-free survival at 2 years after treatment. There will be a 1:1     randomization. A random permuted design will be used to assure approximate balanced number of     patients in the two groups over time.   "
96386|NCT02024542|"     Research the genetic and biomechanical markers of human adipose tissue on patients with     morbid obesity. Additional tissue/fluid collection is also gathered during the time of     surgery.   "
97712|NCT02007200|"     This phase II clinical trial studies how well soy isoflavones work in preventing head and     neck cancer in patients with stage I-IV head and neck cancer undergoing surgery.     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy     isoflavones may prevent head and neck cancer recurrence.   "
96376|NCT02024672|"     Intrauterine devices (IUDs) are one of the most effective reversible forms of contraception,     and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy.     IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal     or cesarean birth. This practice has been shown to be safe, and is recommended by the     American College of Obstetricians & Gynecologists, the World Health Organization and the U.S.     Center for Disease Control. Immediate postpartum IUD placement has the advantage of providing     contraception at a time that the woman is already accessing medical care, avoiding potential     loss to follow up or risk of unintended pregnancy. Additionally, women who have anesthesia     for delivery have reduced pain at the time of IUD placement compared to having the IUD placed     at the postpartum follow up appointment. Immediate postpartum IUD placement is a relatively     new practice in the US and little is known about the expected appearance of IUDs inside the     uterus taken with an ultrasound when they have been placed at the time of delivery. It is     less likely that IUD strings will be visible at the cervix after immediate postpartum IUD     placement due to subsequent uterine involution, which makes it important to monitor correct     positioning of the IUD via ultrasound. This study will document normal changes in the     positioning of the IUD visualized via ultrasound, and determine if a correlation exists     between IUD position and risk of expulsion. Ultrasound surveillance to document IUD position     and distance from the fundus, will be performed at 6 weeks, 3 months and 12 months after     placement. Symptoms of menstrual bleeding and pain will also be recorded in order to     determine if they are correlated with IUD position.   "
96377|NCT02024659|"     This randomized, double-blind, placebo-controlled clinical trial enrolled subjects with     eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation     suspension or placebo for 14 days. Visual analogue scales (VAS）of nasal symptoms, endoscopic     polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp     samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and     tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry;     and frequencies of different inflammatory T cell infiltration by flow cytometry. this study     is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation     suspension via transnasal nebulization by clinical and immunologic assessments. As outcome     parameters for remodeling, differences in the expression of collagen and albumin were     investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs     expression differences in nasal polyps were investigated to explore underlying mechanisms of     tissue reconstitution.   "
96378|NCT02024646|"     The primary objective of this study is to evaluate the efficacy of brodalumab, compared to     placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the     efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is     to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.   "
96379|NCT02024633|"     Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable     safety profile in subjects with locally advanced, unresectable or metastatic pancreatic     adenocarcinoma.The primary objective is to determine the safety profile of icotinib in     combination with gemcitabine in subjects with locally advanced, unresectable or metastatic     pancreatic adenocarcinoma.   "
96380|NCT02024620|"     Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for     increasing the adherence of individuals to psychotherapy treatments which may subsequently     increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for     real-time tracking of behavior and have the ability to provide prompt feedback and reminders     in a convenient, readily available technology. The immediacy and convenience of apps may be     responsible for the observed improvements in adherence on the part of the patients relative     to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy.     These features are relevant to behavioral activation (BA) protocols, the effects of which are     often attenuated by failure to adhere to regular practice and tracking of behavior. The Mood     Coach app is a BA protocol developed to provide a convenient means of planning and tracking     activity, and monitoring mood responses to scheduled increases in activity. This project     evaluates the utility of this app as an adjunct to standard BA treatment. The investigators     predict that participants assigned to the BA+app condition will demonstrate greater adherence     to the BA treatment compared to the standard BA condition. The investigators also predict     that the participants in the BA+app condition will report greater satisfaction with the app     compared to the standard BA protocol that utilizes paper and pencil materials.   "
96381|NCT02024607|"     This is an open label, multi-center, Phase 1/2 dose escalation study of BBI608 administered     in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with     and without bevacizumab, or regorafenib, or irinotecan.   "
96382|NCT02024594|"     Visiting anxious and fearful children is an inevitable prospect of the daily work of every     dentist who treats pediatric patients. Dentists have been using a wide variety of     non-pharmacological and some pharmacologic techniques to assist them in the management of     children with anxiety. One strategy which seems promising for pain control in stressful     medical situations is teaching the child to use behavioral and cognitive coping skills or a     combination of both techniques. An alternative technique to non-pharmacologic approaches in     children being anxious and lacking in cooperative ability is sedative technique such as     nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation     and combinations of cognitive-behavioral strategies in eliminating children's uncooperative     behaviors and dental anxiety, the aim of this study was to compare the effectiveness of     inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral     therapy to reduce dental anxiety in preschool children.   "
96383|NCT02024581|"     This trial will examine the safety, tolerability and efficacy of one strength of East Indian     sandalwood oil (EISO) in a cream base compared to a placebo for treatment of molluscum     contagiosum in pediatric subjects. Trial participants will be asked to apply study medication     twice a day for sixty (60) days. Efficacy will be evaluated by clinical staff and patients     will be asked to assess tolerability as well as any improvement experienced during the trial.   "
96413|NCT02024191|"     Oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal     cancer. The dose limiting side effect of oxaliplatin is neurotoxicity. In this study we aimed     to determine whether glutamine has role in prevention of oxaliplatin induced neuropathy.   "
96387|NCT02024529|"     This is a randomized, placebo-controlled, double-blind study in which 500 patients with     osteoarthritis (OA) knee pain will be randomized to Ampion or placebo and followed for 20     weeks. The clinical effects of treatment on OA pain will be evaluated during clinic visits at     6, 12, and 20 weeks using WOMAC® osteoarthritis Index and the Patient's Global Assessment of     disease severity (PGA). Safety will be assessed by recording adverse events, concomitant     medications, physical examination, vital signs and clinical laboratory tests.   "
96388|NCT02024516|"     The aim of this study is to examine the effects of concentrated pomegranate juice on serum     lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients     aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day     concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements,     3-days food-record questionnaire ,physical activity and fasting blood samples were collected     at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a,     IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The     participants are asked not to change their regular diet, medicine and activity during the     study.   "
96389|NCT02024503|"     Imaging of the ischaemic penumbra with a particular diffusion-weighted imaging (DWI)/     perfusion-weighted imaging (PWI) mismatch is a promising approach to the selection of     patients with acute ischaemic stroke for trials of intervention. The investigators want to     apply multimodal resonance imaging methods such as functional magnetic resonance imaging (     fMRI), diffusion tensor imaging (DTI), arterial spin labeling (ASL) to guide treatment and     predict the prognosis of stroke.   "
96390|NCT02024490|"     Respiratory distress syndrome (RDS) of the newborn, also called as hyaline membrane disease,     is the most common cause of respiratory distress in premature infants, correlating with     structural and functional lung immaturity. The pathophysiology of RDS is complex. Immature     type II alveolar cells produce less surfactant that causes an increase in alveolar surface     tension and a decrease in compliance. This resultant atelectasis lead to pulmonary vascular     constriction, hypoperfusion, and lung tissue ischemia. RDS and prolonged ventilation and     associated systemic/lung injury may also contribute to long term oxygen dependency and may     result in bronchopulmonary dysplasia (BPD). Vitamin D is a fat-soluble steroid hormone that     primarily contributes to the maintenance of normal calcium homeostasis and skeletal     mineralization. In addition to its classical role in bone metabolism, vitamin D deficiency     has been associated with impaired pulmonary function, increased incidence of viral and     bacterial infections and inflammatory lung diseases. Although exact mechanisms are not fully     understood, vitamin D appears to impact on a variety of inflammatory and structural cells     within the lung including macrophages, lymphocytes and epithelial cells. To our best of     knowledge, no study has evaluated the effect of vitamin D levels on the severity and presence     of RDS in preterm infants. Therefore, the aim of this study is to evaluate the possible role     of maternal/neonatal vitamin D levels on RDS development in preterm infants. We also aim to     determine the possible association between maternal/neonatal vitamin D levels and the     incidence of BPD and other neonatal morbidities.   "
96391|NCT02024477|"     Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels     which may contribute to heart disease. Endothelial Progenitor Cells(EPCs) are found in the     blood . Research has shown that improving the survival of these special blood cells may     decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart     disease. Saxagliptin is an FDA(Food and Drug Administration) approved prescription medicine     used along with diet and exercise to lower blood sugar in people with Type 2 diabetes. It is     in a class of diabetes medication called DPP-4 inhibitors. DPP-4 inhibitors have been shown     to increase EPCs in patients with Type 2 diabetes.      Hypothesis: We believe poor viability and function of EPCs in early diabetes ultimately     affects the repair and regeneration of the endothelium and that prompt intervention using     saxagliptin with another oral hypoglycemic agent, Metformin, may reduce or reverse     cardiovascular risk by improving EPC survival and function above and beyond adequate glucose     metabolism control.   "
96392|NCT02024464|"     This clinical trial compares two implantable devices intended to lower the pressure inside     the eye of glaucoma patients. One of the two devices will be implanted immediately following     cataract surgery and the placement of a posterior chamber intra-ocular lens.   "
96393|NCT02024451|"     Myofascial pain syndrome is common in Rehabilitation clinic. The pain occurs asymmetrically     in isolated or regional muscles, and is associated with acute muscle strain or chronic muscle     overuse. Myofascial pain is characteristics with localized muscle tenderness, palpable     intramuscular taut band, typical referred pain, and local twitch response.      Treatment of myofascial pain syndrome includes physical therapy, stretch exercise, dry needle     insertion and trigger point injection. Acupuncture originated from ancient Chinese medicine     which involves the insertion of fine needle to stimulate specific points of the body along     the 12 meridians. The mechanism of pain relief may be initiated by activation of both spinal     segmental and supraspinal centers. Acupuncture is commonly used for pain relief.      Recently, radial shock wave has been shown to be effective in the treatment of chronic     musculoskeletal pain, including calcific tendinitis, epicondylitis, and plantar fasciitis.     The energy and pressure produced by radial shock wave is focused on the treated     musculoskeletal tissue. The mechanism of action has been hypothesized that the energy could     result in analgesic effect and stimulation of angiogenesis and healing response and then     relief of the symptoms. The effectiveness of radial shock wave on treatment of myofascial     pain was reported by Jeon and colleagues in 2012.      The aim of this study is to compare the efficacy of acupuncture and radial shock wave therapy     in patients with myofascial pain syndrome.   "
96394|NCT02024438|"     For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for     chemotherapy. Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse     effects which even result in discontinue of chemotherapy, especially for patients suffered     from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane     of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced     neurotoxicity(OIN). But it did not certificated by phase III trial. A phase III trial is     needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium     Injection for prevention OIN at gastric cancer.   "
97713|NCT02007187|"     The purpose of this study is to determine the efficacy and safety of Danhong injection in the     treatment of unstable angina pectoris.   "
96395|NCT02024425|"     The purpose this study is to evaluate the therapeutic effect of a functional bioactive     supplement associated with a hypocaloric equilibrated diet to treat obese and overweight     individuals. The functional bioactive supplement, containing antioxidant extracted from     rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to     satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as     well as to weight loss.   "
96396|NCT02024412|"     The morbidity of colorectal cancer(CRC) is 10%～15% in China.mFolfox6 has become one of the     standard regimes for metastatic colorectal cancer (mCRC). Neutropenia and oxaliplatin-induced     neurotoxicity are the most common adverse effects which even result in discontinue of     chemotherapy, especially for patients suffered from heavily acute neurotoxicity.     Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II     clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not     certificated by phase III trial. Investigators designed the phase III trial to investigate     the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN     at colorectal cancer.   "
96397|NCT02024399|"     This project will address the important area of childhood obesity and the risk of     cardiovascular disease associated with obesity. This is a serious health concern since     children who are overweight or obese are prone to other medical conditions including high     blood pressure, abnormal lipid profiles,and type 2 diabetes. Although exercise and nutrition     programs are recommended, evidence for the efficacy of these programs in improving     cardiovascular health is lacking.      Specific Aims: a) improve cardiovascular risk factors, b) increase physical fitness levels,     c) improve lean body mass, d) enhance QOL of the child e) influence adherence rates to     exercise and a healthy lifestyle change both during and beyond the conclusion of the program.      Hypothesis 1a: Compared to baseline and matched controls, children randomized to a 10 week     multidisciplinary fitness and nutrition program will show significant improved levels of     cardiovascular risk factors.      Specific Aim 2: To determine if a multidisciplinary fitness and nutrition program, when     compared with a matched, WLC group will show a change in whole body assessment including a     decrease in fat mass, an increase in percent lean body mass, and a decrease in percent body     fat, as measured utilizing dual-energy X-ray absorptiometry Hypothesis 2a: Compared to     baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and     nutrition program will show improved whole body assessments including.      Specific Aim 3:To determine if a multidisciplinary fitness and nutrition program, when     compared with a WLC group will show improved levels of fitness. Hypothesis 3a: Compared to     baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and     nutrition program will show significant improvements in fitness including.   "
96398|NCT02024386|"     During ascent to high altitude there is a physiologic response to hypoxia that results in an     elevated pulmonary arterial pressure associated with decreased exercise performance,     altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat     is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in     the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of     altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy     volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated     pulmonary artery pressures found in conditions of high altitude, allowing observation of the     effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and     exercise performance. Prior to entering the hypobaric chamber, subjects will have radial     arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery     pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise     tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer     (exercise bike) before and after administration of riociguat. If, after administration of     riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is     improved and observed pulmonary artery pressures are lower than those measurements seen prior     to administration of riociguat, this could lead to development of a prophylactic and/or     treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical analysis     will compare the variables of pulmonary artery pressure, radial arterial pressure,     ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after     administration of the drug riociguat. The investigator's hypothesis is that riociguat will     decrease pulmonary artery pressure and improve gas exchange and exercise performance at     altitude.   "
96399|NCT02024373|"     To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic     subdural hematoma (CSDH).   "
96400|NCT02024360|"     The purpose of this research is to investigate the effectiveness of a community health     worker-based program as an adjunct to clinical services regarding childhood obesity     management. This family-centered program will be delivered in the community and homes of     enrolled families. The primary outcome will compare change in age-gender specific     body-mass-index (BMI) z-score (zBMI) over time. All Denver Health children and families will     be enrolled at study inception and receive the intervention in 1 of 5 defined 6-month stepped     wedge engagements. The intervention lasts for 6 months and the time prior to engagement in     the intervention will serve as the control period. Intervention construct validity will be     evaluated using data on diet, activity, and fitness. The primary goal is to examine the     effect of the intervention in reducing the zBMI in the index patient and secondarily on any     participating family members. We will test effectiveness among demographic groups     under-represented in prior studies, including very young children and Latinos. Results from     this study will inform future intervention modifications and permit effect size estimation     and power calculations for future randomized trials that include a community health     worker-based obesity prevention and treatment program. During the course of the study, an     obesity registry will be designed and implemented within an integrated safety-net healthcare     system to measure primary obesity outcomes in a low-income population and conduct analyses.     The community health worker will be using several new technologies (e.g., text messaging and     patient relationship manager [PRM]) as an adjunct when working with an obese child and     his/her family. Targeted training for clients, providers and CHW will be part of the     prevention strategies implemented during the grant period, these will include motivational     interviewing. All of these (i.e., obesity registry, technologies and training) will have an     evaluative component.   "
96401|NCT02024347|"     Liver cirrhosis is an advanced stage of chronic liver diseases, which is often associated     with various complications, namely esophageal and/or gastric varices, ascites, hepatocellular     carcinoma (HCC). It is well known that the risk of complications varies even among cirrhotic     patients, as those with more advanced disease would have more complications and poorer     survival rates. Liver stiffness measurement (LSM) with transient elastography is found useful     to identify cirrhotic patients with higher risk of portal hypertension and presence of     varices . Recently, spleen stiffness measurement (SSM) with the same machine was found     accurate to predict portal hypertension and esophageal varices.      Investigators hypothesized that a new screening strategy guided by LSM and SSM (LSSM) values     (LSSM-guided) is non-inferior to conventional strategy in terms of detection rate of     clinically significant esophageal and/or gastric varices for patients with liver cirrhosis in     an open-labeled randomized controlled trial.      Consecutive patients with compensated liver cirrhosis will be invited for the study. Patients     fulfilling the study criteria will be randomized into LSSM arm (upper endoscopy only     performed to patients with high LSM or SSM values), and control arm (upper endoscopy     performed to all patients). Patients randomized into LSSM arm will undergo transient     elastography examination; those with high LSM or SSM results will be referred for upper     endoscopy examination for to screen varices. Patients randomized into control arm will be     directly referred for upper endoscopy examination.   "
96402|NCT02024334|"     A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of     refractory juvenile idiopathic arthritis.      Patients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos     will be added to conventional treatment for three months. therapeutic responses will be     evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.   "
96403|NCT02024321|"     The purpose of this study is to determine the relationship among TPN, tumor and blood     glucose.   "
96404|NCT02024308|"     The purpose of the study is to determine whether Fludarabine in combination with cytarabine     is more effective than high-dose cytarabine in post-remission therapy for patients with     AML1-ETO acute myeloid leukemia.   "
96405|NCT02024295|"     To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with     cholestasis.   "
96406|NCT02024282|"     Acute illness is the most common presentation of children attending ambulatory care settings.     Serious infections (e.g. meningitis, sepsis, pyelonephritis, pneumonia) are rare, but their     impact is quite large (increased morbidity, mortality, induced fear in parents and defensive     behaviour in clinicians). Early recognition and adequate referral of serious infections are     essential to avoid complications (e.g. hearing loss after bacterial meningitis) and their     accompanied mortality. Secondly, we aim to reduce the number of investigations, referrals,     treatments and hospitalisations in children who are diagnosed with a non-serious infection.     Apart from the cost-effectiveness, this could lead to less traumatic experiences for the     child and less fear induction for the concerned parent. Finally, we aim to support the     clinicians to rationalise their antibiotic prescribing behaviour, resulting in a reduction of     antibiotic resistance in the long run.   "
96407|NCT02024269|"     This will be an open-label, non-randomized multi-center study of adipose stem cell (ASC)     implantation. ASCs will be derived from the patient's adipose or fat. Liposuction using local     anesthesia and syringe collection will be performed to collect the adipose tissue specimen     for subsequent processing to isolate the stem cells. The cells will be delivered via needle     injection into the eye.   "
96408|NCT02024256|"     The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate     and cold water-soaked pads on perineal pain and swelling following vaginal delivery.      Assessment of appropriateness for each patient to take part in the study will be performed     approximately 2 hours following delivery. Those patients who consent to participate in the     trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in     the study group will receive treatment with pads soaked in a cold aqueous solution of     magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive     treatment with pads soaked in cold water.      Nurses will initiate treatment according to the group to which the patient was randomized.     Said pads will be given the patients routinely 5 times a day at regular times.      A physician will assess the perineal swelling according to visual (photographed) scale in     which severe, moderate, light and no swelling will be defined. Measurement of swelling in     centimeters (maximal length and breadth); photography, by a medical photographer or the     examining doctor, of the perineal area with a centimeter ruler, before, during and after     treatment (photography is dependent on patient approval and is not a precondition to     participation in the trial.); and additional examination, on the above basis, will be     performed regarding hemorrhoids in the event that a patient has complained of such.      A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to     the patient being given the pad and an hour following treatment. An additional assessment by     the same method will be performed regarding hemorrhoid pain. Any analgesia administered will     also be recorded.      Likewise, for follow-up purposes a blood test for serum magnesium concentration will be taken     before and after treatment.      Period of follow-up will be 48-72 hours from childbirth.   "
96409|NCT02024243|"     Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound     edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing     outcome in a setting of standard clinical care.      Aim of the study: To determine whether elevated miR-210 in the epidermis of ischemic human     wound edge tissue is associated with poor healing outcome in a setting of standard clinical     care.      This study will last 14 weeks. Adult patients, who are non-diabetic or tightly controlled     diabetic, and, who have chronic venous leg ulcers, that are not infected and have been     open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be     recruited from the OSU Wexner Medical Center Comprehensive Wound Center (CWC). On days 0, 14     and 28, patients will have the following performed: measurements and photographs taken of     their wound; TCOM (transcutaneous oxygen measurement) or ABI to measure the amount of oxygen     in the wound tissue; and two 3-mm punch biopsies from the same wound/ulcer. Biopsies will not     be taken if the wound has closed by day 14 or day 28. Additionally, patients' medical records     will be reviewed throughout the study to obtain information about the patient (age, sex,     race/ethnicity, current medications, TCOM, would location and type, other illness/diagnoses,     wound care treatment and instructions, nutritional status based on albumin levels), and at 14     weeks after enrollment to determine the final status of the wound (healed or not healed).      There will be a total of 5 visits for this study (6 total visits for patients with open     wounds on day 28 of the study). Visits will occur on days 0, 7, 14, 21 and 28.   "
96410|NCT02024230|"     Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who     underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the     prevention of cardiogenic embolism including cerebral infarction in AF patients. However, the     combined antithrombotic therapy has been reported to increase the risk of major bleeding for     AF patients after coronary stenting, New anticoagulant drugs that hardly interact with other     drugs and do not need frequent blood tests have become commonly used. The purpose of this     study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the     efficacy and safety for AF patients after coronary stenting.   "
96411|NCT02024217|"     To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in     Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary     endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of     regime, disease free survival(DFS) and overall survival(OS).   "
96412|NCT02024204|"     The purpose of this study is to understand why patients in the World Trade Center program     have continuing breathing problems. This study will improve investigators understanding of     breathing problems among individuals with World Trade Center exposure by allowing them to     review and monitor medication use, lung function, and examine other conditions that can     contribute to problems with breathing. The findings from the study will help investigators     understand why some people have persistent lower respiratory symptoms (breathing problems)     after their exposure to World Trade Center dust and fumes, and may help guide better     management and treatment of these symptoms.   "
97753|NCT02006667|"     This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous     Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The     anticipated time on study treatment is until disease progression.   "
96418|NCT02024126|"     Osteoarthritis (OA) is one of the most common form of chronic diseases in the adult     population, and approximately 800 000 people in Sweden (population of 9 million people)     suffer from this disease, which causes joint pain, stiffness, swelling, loss of function and     sick leave. There is increasing evidence that exercise therapy is effective for patients with     knee OA. However, there is little knowledge on long-term effects and what type of exercises     dosage is most effective. In this present clinical trial, which is a Nordic collaborative     project with researchers from different research groups in Sweden and Norway, we intend to     investigate short and long-term effects comparing high dosage exercise therapy (each     treatment lasting 80 to 90 min) vs. a relatively low dosage exercise program (25 to 30 min)     in patients diagnosed with knee OA. Patients in both intervention groups receive three     treatments a week for 12 weeks making a total of 36 treatments. Primary outcome is     pain-ratings and function (The Knee Injury and Osteoarthritis Outcome Score (KOOS)).     Secondary outcome concerns various health-ratings and objective functional tests. Regarding     predictors for outcome, we plan also to investigate different psychosocial variables as well     as patient's beliefs regarding exercise.      Patients are being assessed by blinded assessor at inclusion, at end of intervention (3 mo),     and at six and 12 mo after end of treatment. We plan to include a total of 200 subjects from     primary health care settings, two in Norway and two in Sweden, with radiographic-verified     knee OA with knee pain and decreased function. The patients have to be within the 45 to 85     age group. Patients are excluded if they have been scheduled for knee surgery or have some     other form of illness/disease that limits the exercise tolerance (e.g. heart disease or     systemic/metabolic diseases or chronic obstructive airways disease). A major goal is to grade     exercises so that they are performed pain-free or close to pain-free in both intervention     groups. The principle of deloading is used to meet this goal using a high number of     repetitions in sets as pain modulation. The results from this study will give new information     about the effectiveness of graded exercise therapy in patients with knee OA, and new     knowledge if outcome can be related to the exercise dosage performed.   "
96419|NCT02024113|"     Lung cancer is the most common cancer in men and the fourth most common cancer in women     worldwide. Until today no effective method permits the early detection of lung cancer.     Consequently, lung cancer is often diagnosed owing to symptoms of advanced disease. To     address this problem, detection methods with an improved sensitivity and specificity are     urgently needed.      Over the past decade, accumulating evidence shows that the metabolism of cancer cells differs     from that of normal cells. More specifically, the entire metabolism of cancer cells is     reorganized or reprogrammed to increase anabolic reactions that induce cell growth and     survival. Metabolic reprogramming during the development of cancer is driven by aberrant     signaling pathways due to the activation of oncogenes and the loss of tumor suppressor genes.     Furthermore, the microenvironment of the tumor plays a role in metabolic reprogramming. The     altered cancer metabolism is characterized by an increased glycolysis, the production of     lactate and the biosynthesis of macromolecules, such as proteins, lipids and nucleotides.     Cancer cells have a high glycolytic rate and eliminate most of the glucose-derived carbon as     lactate rather than oxidizing it completely via oxidative phosphorylation, a phenomenon known     as the Warburg effect. The breakdown of glucose and other nutrients leads to a high energy     production and provides the Krebs cycle with intermediates, which consequently are allocated     to metabolic pathways that support biosynthesis. Metabolites are the end products of cellular     metabolism and are therefore closely related to the observed phenotype. Disturbances in     biochemical pathways which occur during the development of cancer consequently provoke     changes in the metabolic phenotype. As a result, low-molecular weight metabolites are very     attractive biomarkers for different cancer types. Nuclear magnetic resonance (NMR)     spectroscopy enables the identification and quantitative analysis of complex mixtures of     metabolites, as in plasma and serum, without an extended sample preparation.      The present study aims to determine the metabolic phenotype of lung cancer by means of proton     (1H)-NMR spectroscopy. Once the phenotype determined (training cohort), this has to be     validated by an independent cohort.   "
96420|NCT02024100|"     The study is to identify the effectiveness of Eprosartan on pulse pressure in hypertensive     patients with metabolic syndrome      -Definition of pulse pressure (PP): Difference between systolic and diastolic blood pressure     produced one heart beat.   "
96421|NCT02024087|"     The purpose of this study is to evaluate the safety and tolerability of dalantercept plus     sorafenib in patients with advanced hepatocellular carcinoma (HCC) to determine the     recommended dose level of dalantercept in combination with sorafenib.   "
96422|NCT02024074|"     The objective of this study is to evaluate the usefulness of Tc-99m Sestamibi Molecular     Breast Imaging as an imaging modality for breast cancer screening.      Tc-MBI has shown significantly higher sensitivity and equivalent specificity in the detection     of breast cancer among high risk women when compared to mammography. However, there is little     published data comparing Tc-MBI to MRI for evaluating extent of disease in women with known     breast cancer.      The study will target twenty (20) women with newly diagnosed breast cancer who are scheduled     to undergo biopsy of additional suspicious lesions that were identified on standard of care     contrast- enhanced breast MRI. Prior to the biopsy, these subjects will receive a Tc-MBI scan     of the breast. The results from both imaging methods will be compared to histological     findings. These results may be used to design larger and more comprehensive studies with an     overarching goal to determine if there is a role for Tc-MBI in the pre-operative evaluation     of patients with known breast cancer.   "
96423|NCT02024061|"     The purpose of this study is to analyse if a multidisciplinary approach including peers is     effective in the treatment of obesity in adolescence.   "
96424|NCT02024048|"     The purpose of this study is to evaluate choroidal thickness and volume during the third     trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group     of women   "
96425|NCT02024035|"     The purpose of this study is to do health economic evaluation of tomotherapy and dynamic     arctherapy (2 techniques exist: RapidArc and Vmat).      This study evaluate also local disease control after 18 months in patients with an ENT     epidermoid carcinoma and treated by tomotherapy orarctherapy .      The number of patients required in this study is: 300:        -  Number of patients treated with tomotherapy: 120        -  Number of patients treated with dynamic arctherapy RapidArc: 120        -  Number of patients treated with dynamic arctherapy Vmat: 60      This is a prospective; multicentric and non randomized study.   "
96426|NCT02024022|"     This study aims to compare a standard approach to bowel preparation for colonoscopy (using     sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients     are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG     depending on patient-related factors. The study aims to compare patient-related outcomes such     as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep     quality in the two study groups.   "
96443|NCT02023801|"     This is a clinical study without a formal hypothesis. The primary objective of the study is     to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal     menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due     to benign causes for whom childbearing is complete or no longer wish to retain fertility.   "
96444|NCT02023788|"     This is a 5-year long-term follow-up study of open label, single-center, phase I clinical     trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with     bronchopulmonary dysplasia.   "
96445|NCT02023775|"     Prospective, longitudinal, open-label, multicentre, observational, non-comparative national     study using an exhaustive registry of implantations over a given period.      This study is requested by French Health Authorities for reimbursement renewal, to maintain     reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in     France.   "
96427|NCT02024009|"     This study will evaluate the role of increasing radiotherapy dose and addition of nelfinavir     to chemoradiotherapy (CRT) in patients with inoperable pancreatic cancer that has not spread     beyond the pancreas.      Currently in the United Kingdom (UK), either chemotherapy alone or chemotherapy followed by     CRT can be used in the management of inoperable pancreatic cancer that has not spread. CRT     consists of 25-30 radiotherapy treatments in combination with chemotherapy. Although this     treatment is effective in controlling local symptoms and slowing down the pace of cancer, in     most cases it is unable to shrink it enough to make it operable. Some of the reasons for this     could be the lack of oxygen and lack of blood flow within the tumour making it resistant to     the effects of CRT. This study will investigate whether increasing the dose of radiotherapy,     or increasing the oxygen and blood supply to the tumour by giving nelfinavir, or a     combination of both, can improve outcomes. We also want to know what the additional     toxicities from such intensive approaches are.      All participants will initially receive 12 weeks of chemotherapy, and those with stable or     responding disease will receive further study treatment. The treatment allocation to 1 of the     5 options outlined below will be done at random by computer and neither the doctor nor the     patient can choose the treatment option. The process of randomisation ensures that all     treatment arms are equally balanced in terms of patient and tumour characteristics, and to     reduce the possibility of bias.      The study will consist of 2 stages. In the 1st stage we aim to find the right dose of     nelfinavir to combine with CRT, and this will require around 27 participants of whom up to 18     will receive nelfinavir together with CRT. In the 2nd stage, we want to find out the benefits     of this approach over and above standard treatments and therefore we will recruit the order     of 262 participants and allocate 170 to 1 of the 5 following treatment arms:      Arm A: Nelfinavir together with CRT Arm B: CRT (without nelfinavir) Arm C: Nelfinavir     together with CRT (but using a higher than conventional dose of radiotherapy) Arm D: CRT     without nelfinavir (but using a higher than conventional dose of radiotherapy) Arm E:     Chemotherapy alone (without radiotherapy) Participants who are ineligible or refuse     randomisation will be treated as per local standard but will remain in the study for follow     up at 26, 39 and 52 weeks. Their data will contribute to an Overall Survival (OS) analysis.   "
96428|NCT02023996|"     This study is divided into two groups. The purpose of the first group (Group 1) was to find     the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how long     it stayed in the blood, and to see how well it was tolerated. From what the investigators     have learned from Group 1, patients in Group 2 no longer need serial scans or serial blood     draws.      For Group 2, the patient will receive the injection of 89Zr-DFO-trastuzumab and will be     monitored following the injection. The patient will be asked to return for a picture 5-8 days     after injection to determine how well the study drug attaches to your tumor and how well it     is tolerated   "
96429|NCT02023983|"     The aim of the study is to prove that early discharge (within 72 hours) in selected group of     patients after myocardial infarction with elevations of ST-segment is feasible and safe   "
96430|NCT02023970|"     Cardiac valve disorders are widely spread in the general population and represents the third     most frequent cardiovascular illness after coronary disease and arterial hypertension. In     this context, aortic valve stenosis (the central pathology in this project) is the most     common form of valve disease. Cardiac valve replacement is in the vast majority of cases the     first line therapy for degenerative heart-valve diseases. These are represented by mechanical     and bioprosthetic valve (BHV). In the vast majority of cases, BHV are derived from animals     and from a biological standpoint are classified as xenografts. BHV are severely penalised by     a premature structural damage, with ultimate valve failure occurring around 10 years after     surgery in 5 to 30% of cases, depending on the type of BHV used. Several factors [including     dyslipidaemia, gender, valve position] may contribute to the ultimate failure of the BHV and     there has been increasing evidence recently of a substantial immune reaction elicited by the     implanted BHV. This immune response is still poorly understood. It may lead to adverse immune     reactions and this will be thoroughly investigated by the TRANSLINK team. In this light, the     TRANSLINK project aims to provide the necessary data to demonstrate beyond any reasonable     doubt the central role of the anti-BHV immune response in the premature failure of BHV and to     provide efficient strategies to enable safe implantation of BHV valves in currently     unsuitable candidates   "
96431|NCT02023957|"     The current protocol pertains to the evaluation of the interactive computer-assisted     screening (iCAS) tool through a pilot randomized control trial. The purpose of this     evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection     of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic     stress disorder/alcohol dependence), and patients' discussion on mental health.   "
96432|NCT02023944|"     Interventions aimed at disseminating information about cognitive aging and lifestyle factors     that contribute to successful cognitive aging, in addition to providing broad cognitive     skills training, may improve the psychological wellness and day-to-day functioning of the     aging Veteran population. This 12-week course aims to teach older Veterans (age 50+) about     brain aging, lifestyle factors that contribute to successful aging, and techniques that can     boost cognition in daily life.   "
96433|NCT02023931|"     A pilot study has been designed to determine (primary objective) if three brief interventions     with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including     NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data     and preliminary effect size for specific Nrf2 targets, as measured in serial buccal cell     scrapings, will be determined during the course of 3-day exposures to three BSE regimens.     These data will inform the design of a randomized, phase II chemoprevention trial in patients     with HPV-negative HNSCC.      Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and     female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear     Institute or the Hillman Cancer Center. This may include patients with benign disease or     their friends/family members, or friends/family members of patients with cancer; 2)     Professionals, staff, or students at the University of Pittsburgh.   "
96434|NCT02023918|"     Growth hormone is well known to cause changes in glucose regulation. People with Laron     syndrome are born without the growth hormone receptor and are protected from diabetes. Mice     who are engineered without the growth hormone receptor are similarly protected from diabetes.     Conversely, people who have excessive amounts of growth hormone, such as patients with     acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment     with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the     growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been     explored as a possibility for the treatment of type 2 diabetes or insulin resistance in     people without acromegaly. In this study, the investigators hope to study the metabolic     effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is     expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum     free fatty acids.   "
96455|NCT02023645|"     Past research suggests that retinal lutein levels are related to cognitive function as     measured via behavioral tests. The goal of the present study is to investigate the     relationship between lutein and cognitive function in a wider variety of the population     (young, healthy adults and older adults), using a wider variety of methods (behavioral     testing and neuroimaging).   "
96435|NCT02023905|"     The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001,     also known as Afinitor®) alone or with temozolomide has on the patient and the patient's     low-grade glioma. Everolimus is being investigated as an anticancer agent based on its     potential to prevent tumor cells from growing and multiplying. Specifically, there is a     protein called mTOR that we think helps many tumors to grow, and everolimus blocks the effect     of mTOR. Temozolomide is also an anticancer agent that prevents tumor cells from growing and     multiplying. About 159 people total will take part in this study. Patients will be assigned     to one of three treatment groups depending on the results of some tests done on their tumor.     Each group will have 53 patients in it. 2 groups will receive treatment with everolimus     alone, while the third group will receive treatment with both everolimus and temozolomide. In     this study, patients will be assigned to one of 3 treatment arms based on two characteristics     of their tumor, called 1p/19q (this is a test of the tumor chromosomes) and p-PRAS40     (this is a test of a pathway in the tumor called mTOR). If the patient's tumor is 1p/19q     intact and p-PRAS40 positive, the patient will be assigned to Treatment Arm 1, and the     patient will receive everolimus alone. If the patient's tumor is 1p/19q intact and p-PRAS40     negative, the patient will be assigned to Treatment Arm 2 and the patient will receive     everolimus and temozolomide. If the patient's tumor is 1p/19q co-deleted, regardless of the     p-PRAS40 result, the patient will be assigned to Treatment Arm 3, and the patient will     receive everolimus alone.   "
96436|NCT02023892|"     Healthy subjects take single dose of 80mg atorvastatin, then measured their circulating     endothelial microparticles and flow-mediated vasodilation in the brachial artery by     ultrasound at different time points.   "
96437|NCT02023879|"     Primary Objective:      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of     alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin     lipid modifying background therapy or as monotherapy in comparison with placebo in     participants with primary hypercholesterolemia not treated with a statin.      Secondary Objective:        -  To evaluate the effects on other lipid parameters of alirocumab 150 mg Q4W versus          placebo.        -  To evaluate the safety and tolerability of alirocumab 150 mg Q4W.      Alirocumab 75 mg Q2W was added as a calibrator arm.   "
96438|NCT02023866|"     Patients with mitochondrial diseases, who are ≥ 2 years old and < 18 years, will be included     in this study. It is anticipated that approximately one half of subjects will have     genetically confirmed Leigh Syndrome. Up to 25 patients will be enrolled if there is no     toxicity up to the level of 1.3 g/m2/day of RP103. Interim analyses will occur after 4 and     then 12 subjects complete the study through Week 24. If the study is not stopped early, final     analysis will occur after 25 subjects have completed through Week 24.   "
96439|NCT02023853|"     20 consecutive adult implant patients, presenting the signs of peri-implant mucositis     (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial     peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of     supporting bone ≤30% compared with the situation after implant placement) will be included.      Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic     ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5     minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder     applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time     the subgingival delivery of metronidazole gel will be provided. After instrumentation,     patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.      At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated:     Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).   "
96440|NCT02023840|"     Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of     local metronidazole in the treatment of periodontal pockets.      20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of     their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be     enrolled. For each patients four sites will be considered for the study, and two sites will     be allocated in the test group and two sites will be allocated in the control group. In the     test group, ultrasonic debridement of the pocket will be performed using a piezoceramic     ultrasonic device with the a tip connected to the handpiece for 5 minutes/pocket. Then, it     will be followed by the subgingival use of erythritol powder 2x5 seconds/pocket. At this time     the subgingival delivery of metronidazole gel will be provided. In the control group, the     same protocol will be used except for the use of a placebo instead of metronidazole. After     instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.      At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated:     Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).   "
96441|NCT02023827|"     Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders     themselves. However, research assessing the efficacy of interventions for young offenders     show, on average, only small effects on recidivism, substance abuse, and other behavioral     outcomes. A major problem with existing interventions is that they tend to neglect individual     differences in motivation and readiness to make positive changes. In earlier research, we     used an empirically validated model of behavior change, the Transtheoretical Model (TTM, the     stage model), and expert system technology to develop the Rise Above Your Situation program     (RAYS), a prototype of a multimedia computerized tailored intervention designed as an adjunct     to traditional juvenile justice programs. The intervention delivers assessments and     individualized feedback matched to readiness to stay out of trouble with the law and quit     alcohol and drugs. At the end each session the program also generates a helpgiver report that     summarizes the youth's feedback and presents concrete, easy-to-implement strategies     helpgivers can use to reinforce stage-matched concepts. In the current research, the goals     are to complete development of the computerized tailored intervention; develop training and     other support materials for helpgivers; and assess the efficacy of the intervention package     in a randomized clinical trial involving 700 medium- to high-risk court-involved juveniles     aged 13-17 recruited by 54 probation officers randomly assigned to treatment or standard     care. Primary outcomes will be criminal recidivism and substance abuse abstinence at 6 and 12     months follow-up.   "
96442|NCT02023814|"     Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution     between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest   "
96446|NCT02023762|"     Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a     therapeutic alternative to surgical valve repair in patients who are at high risk and     unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia,     but the MitraClip® is also feasible in deep sedation.      The aim of this study is to investigate the safety of deep sedation in patients undergoing     the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia     influences procedural time and in-hospital stay.   "
96447|NCT02023749|"     This study aimed to investigate the effects of nut consumption on metabolic parameters and     biomarkers related to inflammation, oxidative stress, and endothelial function in Korean     adults with metabolic syndrome.   "
96448|NCT02023736|"     This study is a comparison of client outcomes in two different types of psychotherapy     treatment. In one condition clients will receive treatment-as-usual (TAU); the therapy that     they would normally receive. In the other condition clients will receive treatment-as-usual     but in addition their therapist will have access to empirical feedback on client progress.     Clients in the feedback condition will fill out weekly online questionnaires, and their     therapists will have access to a website that feeds back the results of these questionnaires.     The purpose of the study is to understand the impact of providing such feedback to     therapists. Participating therapists at 4 sites will offer all of their clients the     opportunity to participate, and participating clients will be randomly assigned to either     condition. This should result in a representative sample of client seeking treatment at these     4 Chicago-area clinics.   "
96449|NCT02023723|"     This study is designed as a safety assessment to determine the cardiac and hemodynamic     effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and     blood pressure measurements. It will evaluate the use of a consumer available product that is     classified as a dietary supplement by the FDA.   "
96450|NCT02023710|"     Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment     for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study in     patients with previously untreated metastatic mucosal melanoma to characterize the efficacy     and safety of bevacizumab when combined with carboplatin plus paclitaxel.   "
96451|NCT02023697|"     This study will assess different doses and regimens of radium-223 dichloride on the incidence     of symptomatic skeletal events. Eligible subjects must have castration resistant prostate     cancer with 2 or more skeletal metastases documented within 8 weeks of randomization.     Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen     of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update)     injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after     implementation of NIST update)injections every month for 6 months or an extended duration     regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month     for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for     a minimum of 2 years, at which point they will enter a long term follow-up period during     which they are seen every 6 months for up to 7 years after the last dose of radium     dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic     visit. Pain and analgesic use data will be collected every 4 weeks through Week 48.     Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest     CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue     every 12 weeks thereafter until disease progression is documented in either the bone or in     soft tissue. Radiological imaging will be evaluated by blinded central review.   "
96452|NCT02023684|"     The aim of this study is to evaluate the effect of ropivacaine and lidocaine irrigation at     the surgical bed on postoperative pain relief and breathing parameters in laparoscopic sleeve     gastrectomy.   "
96453|NCT02023671|"     The study proposed by SSCVD Allogeneic Stem Cells of this Hospital provides for the     collection of a series composed of patients with multiple myeloma undergoing allogeneic stem     cell transplants at our center in the period 2000-2011.      This collection is carried out with retrospective investigation , through the review of paper     and electronic records and data cards already collected as part of clinical trials conducted     by our own Division and approved by the Ethics Committee of Management.      The purpose of data collection is particularly retrospective analysis of the incidence of     extramedullary relapse , the response in flow cytometry immunophenotypic and clinical     response of the disease , will also be taken into consideration for overall survival ( OS) ,     event-free survival (EFS) , the cumulative incidence of treatment-related mortality and     graft- versus-host disease ( GVHD ), acute and chronic.      The data were processed in a completely anonymous and as provided by law. The results of the     study will not result in any diagnostic or therapeutic intervention on patients still alive.   "
96454|NCT02023658|"     Despite significant increases in global health investment and the availability of low-cost,     efficacious interventions designed to reduce mother to child HIV transmission in low and     middle income countries with high HIV burden, the translation of these scientific advances     into effective delivery strategies has been slow, uneven and incomplete. As a result,     pediatric HIV infection remains largely uncontrolled. Enhancing the implementation of pMTCT     interventions through contextually appropriate systems analysis and improvement approaches     can potentially reduce drop-offs along the pMTCT cascade, leading to dramatic improvements in     infant and maternal outcomes. The goal of this proposal is to develop a model for systematic     assessment and improvement of pMTCT services in sub-Saharan Africa. In specific aim 1, we     will identify health system factors and service delivery approaches associated with high and     low performing pMTCT services in Côte d'Ivoire, Kenya and Mozambique. In specific aim 2 we     will adapt evaluate the feasibility and impact of a systems analysis tool and associated     performance enhancement approach for pMTCT services in Côte d'Ivoire, Kenya and Mozambique.     This systems analysis tool and associated performance enhancement approach is currently being     developed and piloted for pMTCT services in Mozambique. The results of this implementation     research are expected to generate knowledge of global health significance, and by     disseminating the study results and intervention tools through the broad PEPFAR network, can     rapidly impact pMTCT service delivery enhancements across the highest need countries.   "
97754|NCT02006654|"     To establish efficacy of Lu AE58054 as adjunctive therapy to acetylcholinesterase inhibitors     (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).   "
96456|NCT02023632|"     Regular physical activity is associated with a diverse range of physical and mental health     outcomes, with the effects being particularly pronounced among older adults. Despite these     health benefits, involvement in physical activity has been found to decline over the course     of adulthood with older adults in particular risk of inactivity. A growing body of evidence,     however, suggests that group-based settings that are sensitive to both the age-composition     and gender-composition of their constituent members may represent an opportune means of     supporting the improved adoption and maintenance of older adults in physical activity     programs. The overall purpose of this feasibility trial is to test the effectiveness of a     group-based physical activity program for older adults that is sensitive to both     age-congruent and gender-congruent contextual factors, in supporting their sustained     involvement in physical activity.   "
96457|NCT02023619|"     The purpose of the study was to identify corneal epithelial- and stromal-thickness     distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography     (SD-OCT).      Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal     epithelial and stromal thicknesses for identification of a pattern characteristic for early     keratoconus.   "
96458|NCT02023606|"     An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and     Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers   "
96459|NCT02023593|"     This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line     treatment for metastatic esophageal carcinoma.   "
96460|NCT02023580|"     Although HIV testing and highly effective antiretroviral therapy (ART) have improved survival     with HIV, the relatively low level of ART adherence presents a significant public health     challenge in terms of the potential to transmit HIV. Preventing transmission in virally     unsuppressed HIV+ MSM who have unprotected anal intercourse (UAI) with serodiscordant     partners can have a great public health impact. As new HIV infections in MSM have been     attributed in part to increased access to sex partners online, it is critical to deliver     behavioral interventions to HIV+ MSM online to reach many high-risk men at a relatively low     cost.      The investigators' theoretically-grounded HIV prevention videos about UAI, HIV disclosure,     and testing in MSM were rigorously evaluated among MSM recruited online. Findings indicated     significant reductions in UAI and significant increases in HIV status disclosure at 3-month     follow-up, compared to baseline. In a subsequent online, randomized controlled trial (RCT)     for MSM, investigators found significant reductions in UAI among MSM in the video arm at     60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including     serodiscordant UAI (SDUAI) at 60-day follow-up, compared to baseline. Based on these     findings, investigators worked with POZ.com (POZ), the largest website for HIV+ individuals,     to test whether they could recruit ethnically diverse HIV+ MSM and were very successful. The     investigators have identified a potentially highly effective and feasible risk reduction     intervention approach for HIV+ MSM.      With the commitment of POZ and a strong team of experts, the investigators propose to refine     our intervention by editing our 3 HIV prevention videos into short doses for 10 online     sessions (including boosters); targeting HIV+ MSM who are virally unsuppressed; monitoring     self-reported clinical indicators (i.e., viral load); targeting online recruitment by     race/ethnicity to enroll equal numbers of HIV+ White, Black and Hispanic MSM for balanced     representation; improving retention with incentives and a proven online platform; including     educational information about ART adherence; and cost and cost-effectiveness analyses for     potentially averted HIV infections to determine health-related cost savings. Online, the     investigators will recruit and follow a national sample of 1,500 high-risk, virally     unsuppressed HIV+ MSM for 12 months.   "
96461|NCT02023567|"     Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high     recurrence rate, suicide rate and disability rate. It's reported that the global burden     caused by MDD will be up to the second rank among all the disease burdens by 2020. China is     also confronted with the daunting challenges against MDD. It's assessed that the monthly     incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate     is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current     therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis     of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering     the diversity of weights on genetic factor and environmental factor in MDD, in this project,     the investigators aim firstly to explore the effect of genetic-environmental interactionon     the pathogeny of MDD for classifying MDD into genetic type, environmental type and     others based on a case-control study. We next conduct the neurobiological, neurocognitive     and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the     salient endophenotypes for establishing the diagnostic models of MDD . The investigators     further analyse the changes of these indicators after 8 weeks'medication to select the     potential predictors for therapeutic evaluations and interventional options in MDD patients.     Finally, the investigators continue a 2-year follow-up study to test and verify the     predictors of prognosis in MDD patients.   "
96462|NCT02023554|"     Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere     with the pharmacokinetics of many other drugs that are metabolised by this enzyme like     theophylline.The aim of this study is to determine whether azithromycin can effect     theophylline metabolism in patients.   "
96463|NCT02023541|"     Assess progression-free survival and overall survival of proton beam therapy (PBT) for     patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported     outcomes of PBT for esophageal cancer at 6 months following chemoradiation and     physician-reported toxicity of PBT for esophageal cancer.   "
96464|NCT02023528|"     Based on the Medicare data, the 5-year survival of dialysis patients is only 39%. This is     lower than that of stage IIIB breast cancer (54% 5-year survival). The annual mortality of     dialysis patients is ~ 23% compared to <0.1% in the United States general population. Even     kidney transplant recipients have a substantially higher mortality (~7%) compared to the     general population. Consequently, the life-expectancy of dialysis and transplant populations     is much lower than that of the general population. Cardiovascular events are the leading     cause of death in dialysis patients and malnutrition is also a strong risk factor for death.     The current proposal is to develop a prospective registry of incident dialysis patients at     the University of Utah dialysis program to examine cardiovascular and nutritional factors in     dialysis patients. This registry will include clinical and administrative data. In addition,     blood samples will be stored for future analyses.   "
96465|NCT02023515|"     The purpose of this study is to learn the impact stress may have on weight management and     emotional eating.   "
96704|NCT02019355|"     The main purpose of this study is to determine the effectiveness of a new combination therapy     for actinic keratosis. This study investigates a new indication for an FDA-approved topical     medication, calcipotriol, for treatment of actinic keratosis, including how well it works and     how safe it is when used in combination with the standard of care medication (5-fluorouracil)     for the skin condition.   "
97755|NCT02006641|"     To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic     treatment of patients with mild-to-moderate Alzheimer's disease (AD).   "
96466|NCT02023502|"     Objective: The primary objective of the study is the comparison of protein concentrations     between patients with stress urinary incontinence (SUI) and healthy controls.      Aim: This pilot study aims to determine a possible altered protein profile in women suffering     from SUI, compared to healthy women and therefore to discriminate a potential protein     biomarker for SUI.      Main outcome measure: mass spectrometric measuring of urinary proteomic secretome in diseased     and healthy subjects (sequence coverage and number of identified proteins)      Trial design: Prospective case- control study      Setting: Department of Gynecology and Obstetrics of the Medical University of Vienna in co-     operation with the Core Facilities Proteomics of the Medical University of Vienna      Population: Twenty female patients with SUI and twenty healthy patients who attend the     outpatient clinic of the Department of Obstetrics and Gynaecology, Medical University of     Vienna (sample size calculation FDR 0.05, power of 80%, assumed proportion of true H0 0.95,     assumed standardized effect size of 1)      Methods: Examinations to be carried out: patient history, provocative stress test, ICIQ short     form questionnaire, residual urine volume (ultrasound) and urine analysis (dipstick testing).     A urine sample is obtained from the patient after spontaneous micturition, to which protease     inhibitor will be added immediately. Two serum blood vials (each 9ml) are taken from a     peripheral vein of the patient for routine laboratory and further research.      Proteomics analysis will be performed using chromatographic separation (LC) with mass     spectrometric detection (MS).   "
96467|NCT02023489|"     Background:      Type 2 diabetes mellitus is a main risk factor for cardiovascular disease and heart failure,     in part due to diabetic cardiomyopathy. However, the association between intracellular lipid     accumulation and (myocardial) functional impairment is likely more complex than originally     imagined. Recent studies suggest that not fat per se, but the content of saturated or     unsaturated fatty acids might predict the development of cardiac steatosis and myocardial     dysfunction.      In addition skeletal muscle and hepatic glycogen metabolism is impaired in patients with     diabetes mellitus. Data from animal experiments suggest a relevant role of myocardial     glycogen stores in ischemic preconditioning. Due to methodological limitations so far data on     myocardial glycogen stores and myocardial lipid composition in humans are missing.      Hypothesis:      In addition to total ectopic lipid deposition in the myocardium, myocardial lipid     composition, i.e. the relative abundance of saturated and unsaturated fatty acids, and     impaired myocardial glycogen metabolism may play an important role in the development cardiac     lipotoxicity leading to diabetic cardiomyopathy.      Pancreatic endocrine function and myocardial morphology and function is altered in patients     with heterozygote inactivating mutations of the CaSR-gene / FHH.      Aims:        -  Metabolic virtual biopsy of the myocardium for identification of specific patterns of          intracellular lipid composition and myocardial glycogen metabolism as possible critical          determinants of metabolic cardiomyopathy        -  Characterization of the metabolic interplay between the myocardium, skeletal muscle,          liver and adipose tissues in different stages of development of type 2 diabetes compared          to patients with calcium sensing receptor mutation      Methods:        -  1H/13C and 31P magnetic resonance spectroscopy and imaging for measurements of          myocardial, skeletal and liver lipid and glycogen content, abdominal adipose tissue          distribution and composition, ATP synthesis and myocardial functional parameters        -  Mixed meal tolerance tests to trace the postprandial partitioning of substrates between          insulin sensitive tissues (myocardium, skeletal muscle, liver, adipose tissue).        -  Hyperinsulinemic-hyperglycemic glucose clamp (HHC) with enrichment of the infused          glucose with the stable isotope [1-13C]glucose to trace the incorporation of circulating          glucose into myocardial glycogen      in healthy insulin sensitive volunteers, prediabetic insulin resistant volunteers with     impaired glucose tolerance, healthy subjects, patients suffering from type 2 diabetes     mellitus, patients suffering from type 1 diabetes and patients with heterozygote mutation in     calcium sensing receptor.   "
96468|NCT02023476|"     Nerve injury is a serious potential complication associated with the clinical use of     exsanguinating tourniquets in surgery. Recently, a novel narrow tourniquet has been proposed,     with the claim that it may cause less compression of the nerves. We performed an in vivo     comparison of a standard wide tourniquet with the new, narrow tourniquet. Our study     specifically looked at neurologic markers in the upper extremity.   "
96469|NCT02023463|"     This phase I trial studies the side effects and best way to give enzalutamide, radiation     therapy, and hormone therapy in treating patients with intermediate or high-risk prostate     cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as     enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses     high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone     therapy may be an effective treatment for prostate cancer.   "
96470|NCT02023450|"     Study Rationale:There is recent evidence that HIV protease inhibitors (HIV-PI) can improve     pulmonary hemodynamics in experimental models of pulmonary arterial hypertension (PAH). There     is also experimental evidence that both TLR4 and high mobility group box 1 (HMGB1)     participate in the pathogenesis of experimental pulmonary hypertension. A recent high     throughput screen for inhibitors of HMGB1 induced macrophage activation yielded HIV-protease     inhibitors (PIs) as potent inhibitors of HMGB1 induced cytokine production. Based on the     experimental evidence we propose a trial to determine whether HIV-PIs will alter the     pathobiology of PAH.      Study Objectives:The main objective of this study is to determine whether saquinavir and     ritonavir (SQV+RIT) which have a well-characterized safety profile in humans will reduce bio     markers of inflammation and pulmonary artery pressures in patients with PAH.      Study Hypothesis:We hypothesize that the HIV-PI, SQV+RIT, will reduce circulating parameters     of inflammation including HMGB1, IL1-beta, IL-6, IL-8, IL-10, TNF-alpha and CRP. Our end     points will be changes in these parameters from baseline over the duration of the study.We     hypothesize that treatment with SQV+RIT will reduce pulmonary artery(PA) pressure of patients     with PAH as measured by echocardiography.      Study Design:This is a single center open label phase 0 study to evaluate the effect of SQV     +RIT in patients with IPAH. Subjects with IPAH(N=20) will be enrolled into a study, which     will be divided into 3 cohorts and entail the administration of HIV protease inhibitors in     three doses. The first cohort (n=3) will receive a starting dose of SQV 0.3 mg/kg twice daily     in combination with RIT 0.03 mg/kg twice daily. If the first dose is well-tolerated, the     second cohort (n= 3 ) with IPAH will be given doses of SQV 3 mg/kg and RIT 0.3 mg/kg twice     daily. If the second dose is well-tolerated, the last cohort (n= 14 ) with IPAH will be given     doses of SQV 15 mg/kg and RIT 1.5 mg/kg twice daily.   "
96471|NCT02023437|"     This clinical study is a prospective, post-market-clinical-follow-up study to investigate the     long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study     follow-up extension to the Study #1304 titled as A Multi-centre, Multi-surgeon, Randomized,     Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of     Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation     Procedure.   "
96483|NCT02023281|"     The purpose of this study is to examine the effects of exercise on the symptoms of depression     using serum levels of serotonin, catecholamine's, Alpha EEG asymmetry, and self-report of     symptoms as markers.      In an attempt to further understand the mechanisms of improved mood through exercise; this     study will examine the known factors that contribute to depressed mood in a single study     using serotonin and catecholamine levels via blood serum and EEG slow wave asymmetry. Such     information can be useful in understanding the overall neurological components of depression     and the effects of exercise on the brain in depressed individuals that would make the     prescription of exercise a viable treatment option.   "
96484|NCT02023268|"     Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to     severe Dry Eye Syndrome   "
96485|NCT02023255|"     The purpose of the study is to evaluate the safety and tolerability of multiple dose     administration of JNJ-39393406 in young healthy participants, and subsequently in healthy     elderly participants.   "
96486|NCT02023242|"     This clinical trial compares two implantable devices intended to lower the pressure inside     the eye of glaucoma patients.   "
96472|NCT02023424|"     Primary Objective: To test the hypothesis that 6 months treatment with glatiramer acetate     (GA) decreases epileptiform activity in young girls with Rett syndrome.      Primary Safety Objective:To evaluate the safety and tolerability of 6 months treatment with     GA in these patients.      Secondary Objectives:        1. To test the hypothesis that 6 months treatment with glatiramer acetate (GA) improves          respiratory dysfunction.        2. To evaluate the effect of GA treatment on general behaviour communication, hand          stereotyping, feeding, sleep and other autonomic symptoms: gastrointestinal and cardiac.        3. To assess the effect of GA treatment on bodily development.      Primary Endpoint:Improvement of epileptiform activity as recorded in a 24-hours EEG.      Primary Safety Endpoint:Frequency and severity of treatment-related AEs (including safety lab     parameters).      Secondary Endpoints:        1. Improvement in the scoring of breath holds and hyperventilation, as measured with          non-invasive respiratory inductance plethysmography (NoxT3 device) and parents' diaries.        2. Changes in general behaviour, communication, feeding and motor skills as assessed by the          investigator (based on Kerr and Naidu validated severity scores) and recorded in          parents' diary.        3. Decrease in seizure frequency as reported in parents' diary.        4. Improvement in sleep schedule as recorded in a sleep diary.        5. Change in height and weight. Population:Ten girls, 6 to 15 years old, diagnosed with          Rett syndrome (RTT) Study Design:This is a single - center, exploratory, open-label,          study in 10 girls diagnosed with RTT. The study will consist of four parts: Screening          and baseline assessments, initial and final dose-setting period, treatment period and          end-of study follow-up.      Investigational Product:Glatiramer Acetate (Copaxone® , Teva Pharmaceutical Industries Ltd.)     Sample Size Consideration: The planned sample size of 10 patients was considered adequate by     the investigator for this phase I exploratory proof-of-concept study. The study is not     expected to show statistical significance or statistical power, only a trend for the study     endpoints. Each patient will serve as her own control.      Duration of Study: Approximately 8 months per patient (including up to 2 weeks pre-treatment     assessment, 6 months initial dose and treatment periods and end-of study visit).      Overall study duration: the study is expected to be completed within 12 months (dependent on     rate of recruitment).   "
96473|NCT02023411|"     Diabetic foot represents a major medical , social and economic problem worldwide.      Charcot's neuroarthropathy, being a common cause of diabetic foot, has been an intriguing     topic of research for endocrinologists, podiatrists and surgeons. After its first description     by JEAN-MARTIN CHARCOT in 1868, many theories have been put forward regarding its     pathophysiology , but not much research has been done for its prevention and treatment ,     specially the inactive stage.      The course of Charcot 's neuroarthropathy is triphasic , with the diagnosis being usually     missed in the active stage, henceforth the patients often come to us with a deformed foot. As     a consequence , the osteoclastic activity in active stage renders the foot bones     demineralized and weak, thus being susceptible to fracture and fragmentation.      Teriparatide is recombinant human (1-34) parathyroid molecule that has been approved for     post-menopausal osteoporosis and in men with primary or secondary osteoporosis. It acts by     preferentially stimulating osteoblast over osteoclast activity resulting in new bone     formation and an increase in the rate of bone remodeling which manifest as an increase in     skeletal mass and bone mineral density .      Keeping the pathophysiology of Charcot's foot in mind, teriparatide may be used as potential     treatment for inactive Charcot's neuroarthropathy but there are no studies or randomized     trials in this setting, till date. We hypothesize that teriparatide may increase the     remodeling of foot bones in Charcot's neuroarthropathy, improve bone mineral density,     subsequently leading to a reduction in the risk of fractures and progression of deformities.     This study plans to compare the effects of teriparatide in diabetes patients with inactive     Charcot's foot in a placebo controlled design.   "
96474|NCT02023398|"     Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving     3 cm or greater average waist circumferential reduction in HFT group of subjects relative to     the base line and 1 cm or greater reduction relative to the average waist circumferential     reduction of the Placebo group.   "
96475|NCT02023385|"     Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving     3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to     the base line and 1 cm or greater reduction relative to the average waist circumferential     reduction of the Placebo group.   "
96476|NCT02023372|"     The purpose of this study is to determine whether NuCel is effective in promoting spinal     fusion in degenerative disease of the lumbar spine.   "
96477|NCT02023359|"     An observational study in patients with advanced ER+, HER2 negative breast cancer, who are     treated with everolimus and exemestane in combination. The objective of the study is to     assess the safety pattern of everolimus in a real world setting.   "
96478|NCT02023346|"     The purpose of this study is to learn more about the understanding patients with brain tumors     have of their disease and their communication with their physician. Ultimately, we hope to     use these findings to improve communication between patients and their doctors.   "
96479|NCT02023333|"     The purpose of this study is to evaluate the good and bad effects when regorafenib is used     instead of standard combination chemotherapy. It is not known if taking regorafenib versus     standard chemotherapy will have better, worse or the same results.   "
96480|NCT02023320|"     The purpose of the present study is to evaluate the effect of blueberry dry powder on     glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose     tolerance test (OGTT), or HbA1c) in subjects with prediabetes.   "
96481|NCT02023307|"     This study will evaluate and measure the Vloc suture's ability to elevate the mid-face when     using a short flap, short incision technique in during a traditional face-lift. The objective     of this study is to assess the suture's potential in elevating the mid-face when a     traditional Lifestyle facelift is performed. We hypothesize that the Vloc suture will elevate     the mid-face more effectively when using a short flap, short incision technique on a     traditional facelift.   "
96482|NCT02023294|"     Bariatric surgery has been established as the best treatment for morbid obesity, compared     with diet or medical treatment. Laparoscopic approach have improved the results of this     surgery in terms of postoperative pain, reduction in the number of complications and hospital     stay, as well as better cosmetic results. Conventional laparoscopic technique requires five     to seven abdominal incisions to facilitate placement of the multiple trocars. New Single     Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one     incision is needed for the introduction of all trocars. Altough this technique can be     performed with conventional laparoscopic instruments, new devides have been developed for     facilitate this operations by SILS. The investigators think that reducing the number of     incision would decrease the postoperative pain and improve cosmetic results in our patients,     being a safe and technically feasible intervention supported by these special devices.   "
96487|NCT02023229|"     Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have     decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory     cytokines.      We hypothesized that branched chain aminoacids can improve nutritional status and delay     episodes of hepatic encephalopathy   "
96488|NCT02023216|"     Gastro-esophageal reflux (GER) is a common condition among preterm infants, due to several     physiological promoting factors. To limit the potentially harmful widespread of     pharmacological treatment, a step-wise approach, which firstly applies conservative     strategies, is currently considered the best choice to manage GER in the preterm population.     Among the most common conservative strategies, postural measures seem to represent an     effective measure to reduce GER features in symptomatic preterm babies, whereas feed     thickening is almost ineffective. Non-nutritive sucking (NNS) is a care strategy largely     applied in the Neonatal Intensive Care Unit (NICU) settings. The act of swallowing is both     reported to trigger the onset of transient lower esophageal sphincter relaxations (TLESRs),     thereby eliciting to GER episodes, and to promote the esophageal clearance of refluxate.     Hence, a possible effect of NNS on GER features might be hypothesized.      This observational, prospective and explorative study primarily aims to explore the effect of     NNS, applied by means of a pacifier, on acid and non-acid GER features, evaluated in     symptomatic preterm infants (gestational age ≤32 weeks) undergoing a diagnostic combined pH     and multiple intraluminal impedance (pH-MII). The secondary aim of this study is to evaluate,     in the subgroup of patients with recurrent GER-related apneas, the effect of NNS on     cardiorespiratory events, defined as bradycardias and total, central, obstructive, mixed     apneas and detected by a simultaneous polysomnographic monitoring.   "
96489|NCT02023203|"     Inguinal hernia repair is one of the most commonly performed surgeries around the world. It     accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of     27% in males and 3% in females. Since the modern concept of surgical hernia repair described     by Bassini in 1887, with the technique that bears his name, several techniques have been     developed in the last century in order to improve surgical outcomes after inguinal hernia     repair.      Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach     were described and developed, until Lichtenstein described the tension-free hernioplasty     concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable     Improvements were observed with this technique in terms of recurrence, pain, and discomfort     in comparison with previous tension repairs. Considerable advantages over open repair have     been obtained with the introduction of minimally invasive surgery to inguinal hernia repair,     in terms of patient comfort and recurrence rates.      Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by     Lichtenstein. First generation meshes were manufactured using more material and for this     reason they have been described as heavyweight meshes. New generation meshes have been     designed with less material in order to diminish the inflammatory response and foreign body     reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes.     The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size     of the pore and lately it has been reported that one of the main aspects related to     prosthetic materials is pore size. Large pore meshes use less material, consequently they     have been associated with a better tissue ingrowth. The large pore of lightweight meshes is     conditioned by the less amount of material used.      All previous studies compare both light and heavyweight polypropylene meshes But in order to     get a proper comparison of the behavior of meshes in the inguinal region it is important to     include the material and the pore size. The aim of our study is to compare patient-reported     outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE) vs     a small pore polypropylene mesh (SP-PPL).   "
96490|NCT02023190|"     Liver transplant is the goal treatment for every patient with end-stage chronic liver     disease.      Quality of life improves after transplant because the main complications of end-stage liver     disease disappear, but due to immunosuppression other alterations appear such as metabolic     alterations, weight gain, among others.      Body composition and nutritional status can be affected do to post-transplant pharmacologic     therapy.   "
96491|NCT02023177|"     A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they     have proven to be useful in prognosticating severity of the disease and mortality. However,     PhA needs specific validation in different ethnic groups. The aim of this study was to     evaluate the PhA cut-off value that would best define malnutrition and predict mortality in     patients with liver cirrhosis.   "
96492|NCT02023164|"     This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical     study of JDP-205 injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic     equivalent), in approximately 36 patients with acute urticaria requiring treatment in     Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.   "
96493|NCT02023151|"     This research is being done to test whether differences in blood cells at baseline (start of     the study) can be used to predict how well omalizumab will work in a patient. Omalizumab     (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma.     Studies show that omalizumab improves the symptoms of asthma but some people experience     better improvement than others.   "
96494|NCT02023138|"     There is a lack of evidence about the best method to involve the patient and population (IPP)     into clinical practice guidelines (CPG) development. The goal of this pilot study is to     document the acceptability, feasibility and effectiveness of two methods for the implication     of patients with a traumatic brain injury (TBI) in CPG development. Method: A single blind,     randomized crossover trial will be performed with patients having a TBI. Participants: A     convenience sample of 20 patients a) with a moderate-to-severe TBI (Glascow Coma Scale <13),     b) living with a TBI for two to four years, c) French-speaking, d) able to use a computer and     e) able to participate in a two-hour group meeting will be recruited among the members of the     Associations TCC Des Deux Rives. Procedures: The patients will first receive a in-person     training on guidelines and IPP. They will be randomized into Group 1 or Group 2 by a     researcher blinded to experimentation. They will experiment either group discussion (control     intervention) or a Wiki (experimental intervention). Phase 1: A week after the training,     Group 1 participants will be invited to a discussion group animated by an experimented     moderator, where they will be asked to discuss a CPG recommendation chosen by the research     team in an existing CPG. The participants will be asked : 1) about their opinion of the     recommendation; 2) if they have a preference in regard to the recommendation ; 3) if they     have some modification, correction or addition to bring to this recommendation. In the mean     time, Group 2 participants will receive an email presenting a link to a Wiki. They will be     invited to answer the same three questions as Group 1, but using a Wiki platform. The     patients will have a week to interact and answer the questions; recalls could be sent by     email if required. At the end of Phase 1, participants of both groups will fill a     questionnaire documenting the acceptability of the method experimented. Phase 2: As per the     crossover design, the Group 1 participants will then be assigned to the Wiki intervention and     the Group 2 participants will be assigned to the discussion group intervention. The procedure     will be repeated with a second recommendation. At the end of Phase 2, the patients will be     asked to answer a short survey to validate their preferences about the two methods. Tools:     The acceptability of the methods will be evaluated with a questionnaire adapted from Sidani     and al. and validated with three TBI individuals. The feasibility of the intervention will be     evaluated using a) the number of participants who reached the group or the Wiki, b) the     number of participants who completed the intervention c) the number of support interventions     required in the group and in the Wiki. The effectiveness of the two methods will be evaluated     by submitting the adapted recommendations to a panel of expert clinicians evaluators blinded     to the methodologies of recommendations adaptation. They will be invited to rate the clarity,     accuracy, appropriateness and usefulness of the recommendations. Analysis: Feasibility     indicators will be reported using descriptive statistics. Within-subject analysis using     non-parametric statistics will be performed to assess the acceptability of the two methods.     AC1 coefficient of raters' agreement will be calculated on the expert evaluation scores, and     the effectiveness of the methods will be compared using appropriate non parametric statistics     to. Impact: This pilot trial will be the first one to evaluate methodologies for involving     disabled individuals into CPG development.   "
96495|NCT02023125|"     This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2)     on the single oral dose pharmacokinetics of alectinib in healthy volunteers.      Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or     BA) in which they will receive a single, oral dose of alectinib per period separated by at     least 10 days. Each participant will receive single, oral doses alectinib given under fasted     conditions (Treatment A) or following the ingestion of a high fat, high calorie meal     (Treatment B) as determined by their assigned sequence.      Participants in Group 2 will be given a single, oral dose of alectinib following a standard     meal. After a washout period of at least 10 days, they will receive an oral dose of     esomeprazole (40 mg) once daily for 6 days. On the 6th day of esomeprazole administration, a     single, oral dose alectinib will be given after ingestion of a standard meal.      In all groups, pharmacokinetics will be assessed in the 4 days following alectinib     administration.   "
96496|NCT02023112|"     This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and     cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of     ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic     HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects     with and without compensated cirrhosis.   "
96497|NCT02023099|"     This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies:     Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2     (SS2) will be open label and enroll subjects with compensated cirrhosis.   "
96552|NCT02022384|"     In this explorative study immunological changes during tumor therapy will be analyzed in     patients with malignant glioma. Immunophenotyping before and during therapy is used as     analysis method. Thereby immune cells are quantitatively and qualitatively detected from     patient's blood at continuous time points. Additionally relevant mediators like cytokines,     danger signals and chemokines are analyzed by other methods. Obtained results may give     information about the effects of therapy on immunological processes and immune cells and may     help to find immunological based predictive or prognostic tumor markers and to define time     points for including additional immune therapy in the future.   "
96498|NCT02023086|"     This study aims to evaluate blood oxygenation at the optic nerve head in relation with visual     field losses observed in many Fabry patients. Data collected will allow to evaluate if there     is a link between these two entities.      Study will last up to 2 years during which a limited number of Fabry patients will be     compared to a control group to confirm any relationship between blood flow and field losses,     and to see if these results vary over time.      HYPOTHESIS      1. Fabry patients will present significant differences in visual fields compared to control 2     There will be variability of the visual field defects on the long term but not on the short     term 3 Blood oxygenation will be higher for Fabry patients 4 Blood volume at the optic nerve     head will be the same for both groups.   "
96499|NCT02023073|"     The use of lasers in medicine in general, and diagnosis and treatment in ophthalmology in     particular, increased significantly. Making retinal surgery using lasers have become     increasingly common. The goal: to diagnose eye diseases safely   "
96500|NCT02023060|"     The objective is to observe trends in patient characteristics and outcomes after aortic or     mitral transcatheter heart valve replacement over time.   "
96501|NCT02023047|"     This is an open label study. The study will consist of 2 treatment group: coated Nifedipine     suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated     Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2).     Approximately 30 subjects will participate into this 8-week study. The primary objective is     to examine the dose effect of coated Nifedipine suppository on Anal fissure pain and healing.   "
96502|NCT02023034|"     Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few     studies describe the effects the virtual exercises on the clinical and functional outcomes in     this disease.      Objectives: To analyze the effectiveness of virtual exercises on functional exercise     capacity, fatigue and quality of life in patients with PD.      Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups:     group of virtual exercises associated with conventional exercises (n = 10) and control group     with conventional exercise group (n = 10).      The following variables are evaluated: functional exercise through walking test in 6 minutes,     fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life     Questionnaire-PDQ-39.   "
96503|NCT02023021|"     Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than     5%. About 25% of patients have the opportunity for radically surgical resection when     diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical     trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced     overall survival for patients who have undergone surgery to remove their tumor.     Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies     showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival     and overall survival of metastatic pancreatic cancer patients. The present study is intended     to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel     as adjuvant chemotherapy in treating patients with pancreatic cancer after curative     resection.   "
96504|NCT02023008|"     This pilot clinical trial studies interactive gentle yoga in improving quality of life in     patients with stage I-III breast cancer undergoing radiation therapy. Interactive gentle yoga     may improve the quality of life in patients with breast cancer undergoing radiation therapy.   "
96505|NCT02022995|"     Protein arginine methylation is an important process, which regulates diverse cellular     functions including cell proliferation, RNA stability, DNA repair and gene transcription.     Based on literature search, protein arginine methyltransferase (PRMT) indeed plays important     roles in colon cancer pathophysiology. The PRMT expression level is involved in colon cancer     patient's survival and has been suggested to be a prognostic marker in colon cancer patients.     Recently, our group found a novel methylation on epidermal growth factor receptor (EGFR),     which affected EGFR downstream signaling. investigators further observed the methylation     event on EGFR not only regulated tumor growth in mouse xenograft model but also influenced     cetuximab response in colon cancer cell lines. To further study the clinical correlation     between EGFR methylation and cetuximab response, we propose to detect EGFR methylation level     in paraffin embedded tissue samples from colorectal cancer patients with or without cetuximab     treatment by IHC staining and analyze its correlation with cetuximab response. This study     will provide an insight to the strategy of colorectal cancer therapy.   "
96506|NCT02022982|"     This research study is evaluating the experimental drug palbociclib in combination with     another experimental drug PD-0325901 as a possible treatment for cancers with KRAS mutations,     particularly for those which started in the lung.   "
96507|NCT02022969|"     Even though experimental lung injury in animal experiments is the best analogy for the     changes in the patients, it has to be considered that kinetics may vary between species. An     important question to answer is how common PaO2-oscillations occur in patients and how     injurious they might be. A limitation to the detection of PaO2-oscillations is a sensing     device that detects the oscillations at very high temporal resolution. In previous studies a     fiberoptic probe was used, which was measuring PaO2 based on oxygen-sensitive fluorescence     quenching with a time resolution up to 10 Hz (8, 13, 14). This method is not feasible in     patients. Previous studies have shown that PaO2-oscillations are translated into the     peripheral hemoglobin oxygen saturation (SpO2). Given a technology that has a time resolution     that is high enough (i.e. >1 Hz), measurement of SpO2-oscillations would be a valid approach     to detecting and quantifying cyclical recruitment and derecruitment in a non-invasive fashion     in patients on the ICU. The Masimo Rad-8 pulse-oxymeter provides such a method. In the     current study it is planned to deteted SpO2-oscillations in the post-operative patients on     the ICU.   "
96508|NCT02022956|"     The purpose of this study is to evaluate the PK properties, tolerability, and safety of     lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old   "
96613|NCT02021578|"     The primary aim is to prevent depression in youth and parents in a single, integrated family     intervention.      Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have     significantly fewer onsets of depressive episodes and lower levels of anxious/depressive     symptoms as compared to children in the Written Information (WI) condition.      Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly     lower for those in the FDP program as compared to those in the WI condition.   "
96509|NCT02022943|"     The Alzheimer's Prevention Registry (www.endALZnow.org) will collect contact and demographic     information on individuals. The objective is to provide information the latest news and     advances in Alzheimer's prevention research, and to inform enrollees about research studies     in their community. Enrolled individuals will receive regular email communications. As     research studies become available, individuals will be notified via email with information as     to how proceed should they be interested. Registry enrollees are under no obligation to     participate in a research study. Study opportunities may include surveys, healthy lifestyle     interventions (e.g., diet, exercise), memory & thinking tests, brain scans, and     investigational drug trials. To join the Registry, please visit www.endALZnow.org   "
96510|NCT02022930|"     The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy     for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and     long lasting pain relief for up to six months with a single IA injection.   "
96511|NCT02022917|"     This study is to determine the feasibility of postoperative platinum-based chemotherapy plus     adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval     surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.   "
96512|NCT02022904|"     This is a minimal risk correlative clinical blood-drawing protocol. The objective of this     lead in pilot component is to determine whether Circulating Tumor Cells (CTC's) can be     captured using the novel mesenchymal-marker based Near Infrared-Emissive Polymersomes     (NIR-EPs), the PSMA-based NIR-EP, and the epithelial EpCAM-based NIR-EP. If successful, the     capture method will be evaluated further in the larger comparative study.   "
96513|NCT02022891|"     Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long     care. In children, the disease may cause intense pain and other severe complications. Studies     show that sources of stress, as well as complex psychological and intercultural issues     associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model     used is systematic psychological and medical care. Our hypothesis is that this care is     beneficial for both the children and their families as seen in improved quality of life and     positive impact on medical symptoms.   "
96514|NCT02022878|"     Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing     coronary angiography. The presence of an untreated CTO has been related to adverse clinical     prognosis, both in stable angina and acute myocardial infarction, and is often associated     with persistent symptomatic angina. Depending on their symptomatic and functional status as     well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy     combined with coronary revascularization.      The potential benefits of percutaneous coronary intervention (PCI) in CTO include symptom     relief, improved left ventricular function, and potentially a survival advantage associated     with success when compared with failed revascularization. Of note, marked advances in     endovascular techniques and device technology have resulted in substantial improvements of     procedural success rates of PCI in CTO.      In spite of these advances, the vast majority of patients with CTO are still being managed     medically or referred for coronary bypass surgery rather than PCI. The most common reason for     deferring PCI in patients with CTO appears to be the uncertainty of predicting the procedural     outcome of percutaneous revascularization. Further barriers to attempting CTO by PCI include     the difficulty of gauging the time required for the procedure and the use of resources.      The CT-RECTOR (Computed Tomography REgistry of Chronic Total Occlusion Revascularization)     study was designed to evaluate the application of coronary computed tomography angiography     (CTA) for the prediction of procedural outcome of PCI in CTO in an international patient     population. The main purpose of this multicenter registry is to develop a noninvasive     CTA-based prediction tool (CT-RECTOR Score) for grading CTO suitability for PCI.   "
96515|NCT02022865|"     The main causes of adverse pregnancy outcome(s) are reported to be maternal infection and     placental, foetal, or uterine pathosis. Maternal infection and placental pathosis appear to     be the most important causal factors, possibly causing pre-term labour, premature pre-term     membrane rupture, or result in medically induced pregnancy interruption. There are reports of     a link between poor maternal periodontal health and composite adverse pregnancy outcome of     pre-term low birth weight (PLBW). however, the reason for such correlation is still not     clear.      In the current study the investigators will try to follow a possible path between periodontal     infection and uterus physiology, by signaling out inflammatory markers that may leak from the     gingival fluid into the serum and from there to the amniotic fluid.      the investigators will collect GCF, serum and amniotic fluid from patients undergoing     elective amniocentesis and analyse inflammatory markers in the collected samples.   "
96516|NCT02022852|"     Compared curative effect，safety and compliance between concurrent chemoradiotherapy and     chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.   "
96517|NCT02022839|"     We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill     patients candidates to liberation from mechanical ventilation in predicting weaning outcomes.     The analysis will be taken in two times: immediately before and at the and spontaneous     breathing trial.   "
96518|NCT02022826|"     This protocol is designed to validate use of the SPM for diagnosis of delayed gastric     emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on     patient management in the gastroparetic populations. Patients with symptoms of gastroparesis     will be recruited.      Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the     presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for     each technique.   "
96519|NCT02022813|"     Having previously demonstrated that supplemental parenteral nutrition to complete an     insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical     illness, by reducing infectious complications, the present trial aims at investigating the     underlying carbohydrate and protein metabolism changes, as well as the immune and     inflammatory modulations associated with this improvement.   "
96705|NCT02019342|"     The purpose of this study is to determine        1. whether intraoperative hypotension or hypertension is independently associated with          postoperative mortality and morbidity        2. whether quality improvement interventions implemented at the University of Michigan and          at Washington University:             1. decrease the extent and duration of intraoperative hypotension and hypertension.             2. are associated with decreased postoperative mortality and morbidity.   "
96520|NCT02022800|"     In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral     tumor, there is currently complex clinical situations in which the clinic and Magnetic     Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive     diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at     least 3 months in order to clarify the situation, with a potential delay in diagnosis and     therefore therapeutic care. The contribution of cerebral molecular imagery could allow for     new additional information to be brought in or to increase the confidence index in the     diagnosis in order to comfort the therapeutic collective attitude proposed in the     multidisciplinary meeting (MM).      3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid,     Position Emission Tomography (PET), allows for the studying in vivo of the proteic     transmembrane transport in gliomatous tissue; active transport happens through a     sodic-independent canal, increased in malicious transformations, and in which kinetics can     give an indication regarding the development of the primary tumor.      In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in     the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is     independent of the state of integrity of the BBB and whose only function is metabolic tissue     activity. This method of imagery thus appears as a promising contribution to conventional     imagery.      Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose),     similar to the largely used glucose in oncologic molecular imagery, exploration of harmful     glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless     in a healthy cerebral cortex, with the exception of striatal physiological fixation used as a     level of reference. The best performances in terms of positive and negative predictive value     were defined in the literature with a tumor/striatum threshold of 1.      According to the latest and current European recommendations, turning to PET when caring for     high-level gliomas patients can be proposed in the evaluation of therapeutic responses.     However, very few studies have evaluated the in-practice current clinical contributions of     PET and put it into perspective with classic clinical radiological data.   "
96521|NCT02022787|"     This study was designed as a pilot study to try and find a Chemokine that may be specific for     renal cell carcinoma   "
96522|NCT02022774|"     The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in     patients with hypertension   "
96523|NCT02022761|"     This is a single centre, randomized, double-blind, placebo-controlled, single ascending dose     study, in which the safety and pharmacokinetics of laninamivir octanoate administered by     inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic     asthma.   "
96524|NCT02022748|"     A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and     tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal     function.   "
96525|NCT02022735|"     The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on     walking in patients with Parkinson's disease that have had DBS. While DBS improves     Parkinson's disease (PD) symptoms and walking in many patients in some of the patients     walking problems persist. This study aims to find out what are the best stimulation     parameters of the DBS in order to improve walking.   "
96526|NCT02022722|"     The purpose of this study is to evaluate which treatment option for pelvic floor pain allows     for improved sexual function.   "
96527|NCT02022709|"     The purpose of this study is to evaluate the efficiency of SSRIs（Selective Serotonin Reuptake     Inhibitor） ,ERP（Exposure and Response Prevention） and the combination of the two therapies     for OCD(Obsessive-Compulsive Disorder) patients ,at the same time, to find out the biological     or psychological predictors of treatment response in Chinese population.   "
96528|NCT02022696|"     This is a clinical gene transfer study that aims to verify the safety and efficacy of the use     of the EFS-ADA lentiviral vector to introduce the human adenosine deaminase (ADA) gene into     the hematopoietic progenitors of patients affected with severe combined immunodeficiency due     to ADA deficiency. The EFS-ADA vector expresses the human ADA cDNA under the control of the     elongation factor alpha short promoter (EFS). In addition, this protocol will examine the     effects of the ADA gene transfer on the immune system of treated patients. Patients with ADA     deficiency and ineligible for matched sibling allogeneic bone marrow transplantation are     eligible to participate in the study. To increase engraftment and selected advantage or     gene-corrected cells, busulfan will be used as a cytoreductive agent. Enzyme replacement     (PEG-ADA) will be discontinued 30 days after infusion of gene-corrected cells. CD34+     hematopoietic progenitors will be isolated from the patient bone marrow, peripheral blood or     cord blood, exposed to lentiviral vector-mediated gene transfer and re-infused into the     patient through a peripheral vein. Clinical, immunological and molecular follow-up studies     will assess safety, toxicity, and efficacy of the procedure.   "
96529|NCT02022683|"     To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr     Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous     emphysema patients in a controlled trial design setting.   "
96530|NCT02022670|"     The proposed research will determine the effectiveness of nitrite, a naturally occurring     compound in the body, for improving the health and function of arteries in middle-aged and     older adults. The study also will provide insight into how sodium nitrite therapy improves     artery health by determining the physiological mechanisms (biological reasons) involved.     Overall, the proposed research will provide important new scientific evidence on the     effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases     with aging.   "
96531|NCT02022657|"     The primary objective of this study is to define the mean, variance, and dose proportionality     for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of     daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil fumarate (as     Truvada®). With this information, a model will be established to predict adherence rates to     TFV-DP using DBS. Forty-eight healthy HIV-uninfected adult participants who are at low risk     for HIV infection will be randomized to one of 6 sequences consisting of two directly     observed dosing regimens, 33%/67%, 33%/100%, 67%/33%, 67%/100%, 100%/33%, and 100%/67% with     each dose regimen lasting approximately 12 weeks, separated by an approximately 12 week     washout period. DBS will be collected at regular intervals, including during the washout. The     hypothesis of the study is that levels of TFV-DP in DBS will predict adherence rates in the     preceding 1-3 months.   "
96532|NCT02022644|"     This is a dose-toleration study designed to investigate and determine the maximum tolerated     dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered     directly into the tumor using a process called convection-enhanced delivery. (CED)   "
96706|NCT02019329|"     This randomized, double-blinded, placebo-controlled study will investigate the safety,     tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to     psychiatrically stable patients with schizophrenia receiving risperidone.   "
96533|NCT02022631|"     The investigators will conduct a parallel two-armed, non-inferiority randomized trial     comparing new alternative formats of summary of findings tables (SoF) tables with current     formats. The investigators will contact Cochrane review users by email and will ask them to     fill a questionnaire developed using the Survey Monkey online system. The survey will     include questions about baseline information (demographic characteristics, background, number     of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then,     participants will be stratified (health professional, guideline developer, researcher) and     randomly assigned to one of the two SoF table formats, either the alternative (Table A) or     the current one (Table C). Participants will be asked to answer questions to determine     understanding, accessibility, and satisfaction with the formats to which they were     randomized. Finally, the investigators will show them the table format to which they were not     initially allocated in order to test their preference for either one.   "
96534|NCT02022618|"     Objectives: To analyze the influence on the presence of target organ damage renal, cardiac     and vascular of peripheral and central blood pressure, retinal vessels caliber, oxidative     stress and polymorphisms of genes VAV-2-3 in hypertensive subjects.      Methodology: A cross- sectional design we will performed . Population: 486 hypertensive     patients. Target organ damage will be assessed by tests recommended in 2013 European     guidelines of hypertension. Blood pressure office and ambulatory, retinal caliber     vassels,oxidative stress and polymorphisms VAL -2-3 will be measurement.   "
96535|NCT02022605|"     Previous studies have demonstrated that coached EMS practice at the beginning of ERCP     training could improve the trainees' skill. However, it is not known whether continuously     coached practice using EMS can provide additional benefit.   "
96536|NCT02022592|"     A goal directed , demand-driven administration of sedative drugs is an integral part of every     intensive care treatment. During long-term application of sedatives, Midazolam is the most     commonly used sedative in Europe.      One major objective is the problem of oversedation and agitation during an intensive care     treatment due to the lack of controllability of available substances.      The Love-Mi RCT investigates the clinical controllability of Midazolam versus the newly     available intravenous drug Lormetazepam.   "
96537|NCT02022579|"     A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested     to define cancerous from non-cancerous lesions in the breast.   "
96538|NCT02022566|"     Physical activity level is measured at baseline and after 3 and 12 months after structured     information and individually adapted exercise for patients with osteoarthritis in hip or     knee.      The hypothesis of this study is that a supported self management of osteoarthritis program     will increase the level of physical activity in patients with osteoarthritis in hip or knee.     The second hypothesis is that patients with osteoarthritis in knee will increase their level     of physical activity more than patients with osteoarthritis in hip.   "
96539|NCT02022553|"     AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment     of patients with locally advanced rectal cancer using endovascular methods and reservoir and     plastic surgery.      TASKS OF RESEARCH.        1. To assess the immediate and long-term results of combined (chemoradiation and surgical)          treatment for locally advanced rectal cancer.        2. To make a comparative evaluation of the results of independent surgical and combined          (chemoradiation and surgery) treatment of patients with locally advanced rectal cancer.        3. To examine functional results of surgical treatment with the formation of neosphincter          and neorectum in patients with colorectal cancer..        4. To study features of blood supply to the rectum from the pools of the inferior          mesenteric and internal iliac arteries, using the method of selective angiography, in          connection with the development of endovascular treatment of rectal cancer.        5. To develop and introduce into clinical practice method of one-stage selective          intra-arterial oil chemoembolization of upper, middle and lower rectal arteries in          patients with locally advanced rectal cancer, who have a contraindication to          preoperative radiotherapy.        6. To assess the immediate and long-term results of combined (endovascular and surgical)          treatment for locally advanced rectal cancer.        7. To optimize tactics of combined treatment of locally advanced rectal cancer by          developing an algorithm of using chemoradiotherapy and endovascular interventions in the          preoperative period.      NOVELTY OF RESEARCH.        1. As a result of research will be designed and implemented a new method of selective          intra-arterial chemoembolization in rectal arteries preoperatively in patients with          locally advanced rectal cancer.        2. Substantiated high effectiveness of the proposed technique for the removal of colonic          obstruction and, as a consequence perform radical surgical treatment of these patients.        3. First developed dosage and concentration of chemotherapeutic agent and embolic agent for          safe injection when performing selective intra-arterial chemoembolization of rectal          arteries.        4. Developed complex techniques of selective intra-arterial chemoembolization of rectal          arteries preoperatively in patients with locally advanced rectal cancer.        5. Will be made a comparative analysis of the postoperative period and the evaluation of          the quality of life of operated patients Obtained data will be presented for use in          clinical practice. POSSIBLE APPLICATION AREAS. Results of the research designed for use          in the treatment process of departments of Coloproctology, oncology, as well as the          educational process of higher and secondary medical institutions.      EXPECTED EFFECTIVENESS.      It is expected that the use of this method of treatment of patients with locally advanced     rectal cancer in clinical practice will provide pronounced effect:        1. Medical and social - improving the quality of care, preservation of social activity of          patients, reducing mortality;        2. Economic - reducing the time of patients' treatment and reducing the number of          therapeutic manipulation;        3. Science and Technology - improving of the training level of medicine workers in the          treatment of patients with rectal cancer.   "
96540|NCT02022540|"     The objective of this study is to assess the safety and tolerability of topical ocular     PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with     neovascular Age-Related Macular Degeneration (AMD).   "
96541|NCT02022527|"     The combined Antiplatelet and Anticoagulant treatment decreased thrombus formation and     overall mortality. Also the initiation of an efficacious early anticoagulation protocol is     important because of its potential impact on the rate of early thromboembolic complications     after mechanical valve implantation. An important question that remains to be answered is     whether the combination would be cost effective than Warfarin alone, with a reduction in     major bleeding. In addition, the knowledge about its cost-effectiveness has not yet been     established in Egypt. The aim of this trial based economic evaluation is to conduct a     cost-effectiveness analysis for combination of low-dose Aspirin and Warfarin versus Warfarin     alone in prosthetic valve patients from the medical provider perspective specially that a     misconception is still existed between the physicians in Egypt that the cost of complications     is not worthy so our main aim is to test the cost of complications.   "
96542|NCT02022514|"     Clinical trial phase III, prospective, controlled, randomized, open.      We hypothesize work that patients with chronic coronary occlusion and poor myocardial     viability who failed to recover ventricular function after subjecting coronary     revascularization with new techniques of recanalization, could achieve an improvement of     ventricular function if given further regenerative treatment with mononuclear cells from     autologous bone marrow.      To test this hypothesis we designed a prospective, randomized clinical trial in patients with     recanalized chronic occlusions and ventricular dysfunction.   "
96543|NCT02022501|"     The purpose of this study is to assess the safety, tolerability, bioactivity and     pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in     subjects with late stage exudative age-related macular degeneration.   "
96719|NCT02020382|"     The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon     (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and     non-IBD colitis)   "
96544|NCT02022488|"     Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral     midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children,     undergoing urological surgery with sevoflurane anesthesia was included in the study. All the     children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then     enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were     given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given     10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline     group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask     acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with     Pediatric Anesthesia Emergence Delirium score.   "
96545|NCT02022475|"     Primary objective      -Change in Fatigue Assesment Score (FAS) between the first visit (baseline) and 28 (+maximum     7) days after oral administration of 100 000 E vitamin D (Cholecalciferol).      Secondary objectives        -  Effect of oral administration of vitamin D on serum vitamin D levels (25-Hydroxy-Vitamin          D = Colecalciferol), PTH, Calcium, and Phosphate as compared to placebo.        -  Efficacy of vitamin D (Colecalciferol) administration on fatigue using the short          self-developed FCA-Test        -  Safety of 100 000 E oral vitamin D (Colecalciferol) administration as compared to oral          placebo. Laboratoty parameters such as serum calzium and phosphate levels and the number          of adverse events compared to placebo will be used for safety monitoring.        -  Efficacy of oral administration of vitamin D (Cholecalciferol) on plasma FGF-23,          Sclerostin and Klotho levels compared to placebo.   "
96546|NCT02022462|"     The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of the     general population, meaning that those with a serious mental illness die, on average, 25     years earlier than those without an SMI. These deaths are largely attributed to preventable     medical conditions, many of which are more common in the SMI population.      The Bridge intervention is a peer navigator model that was developed to target factors that     negatively impact healthcare access, utilization, and outcomes among individuals with serious     mental illness (e.g., severe mood disorders and psychotic disorders). This intervention     targets male and female, adult consumers across races/ethnicities and has been utilized by     Pacific Clinics (Southern California's largest behavioral healthcare agency) and the     Department of Mental Health of Los Angeles County to improve the health and quality of life     for their consumers.      Investigators will test the comparative effectiveness of a peer navigator intervention (the     Bridge) to treatment as usual. The Bridge navigator intervention is designed to teach SMI     consumers the skills to engage health care providers and to overcome motivational deficits in     order to improve their health and healthcare use. The specific aims of this application are:        1. To use randomized methods to examine the effectiveness of the Bridge intervention on the          health care utilization, satisfaction with care, health status, and health care          self-management for a sample of individuals with severe mental illness receiving public          mental health services in the community;        2. To use randomized methods to examine the effectiveness of the Bridge intervention on          psychological and social well-being for a sample of individuals with severe mental          illness receiving public mental health services in the community.      Up to 146 participants in an Full Service Partnership (FSP) clinic operated by Pacific     Clinics will be recruited to participate in an approximately 24 month long study of Bridge     navigation. Participants will be randomly assigned to either treatment as usual (waitlist) or     immediate intervention with the Bridge.      Participants in both groups will complete three assessments (baseline, 6 months, 12 months)     and statistically compared over time. Staff stakeholders (n = 20) will also be interviewed at     baseline and every three months of the study in order to ensure that the intervention is     being implemented appropriately.   "
96547|NCT02022449|"     To explore maternal biological (activation of the hypothalamic-pituitary-adrenal axis) and     behavioral (smoking, sleep behavior, exercise and alcohol use) pathways of     intervention-related decreases in inflammation. Hypothesis: The intervention group will show     decreased levels of cortisol and improved health behaviors from pre- to post-intervention     when compared with the control group. We will also explore whether intervention-related     changes in these parameters predict symptoms of illness. Exploratory Aim 2. To explore     psychological pathways of intervention-related decreases in distress among mothers, including     the perception of social support and the use of behavioral coping strategies that are     components of the intervention. Hypothesis: Increases in perceived social support and use of     active behavioral coping strategies will be associated with intervention-related decreases in     symptoms of depression, anxiety and psychological stress.   "
96548|NCT02022436|"     The goal is to non-invasively study the metabolic processes within the aortic wall that are     thought to explain progression to clinical manifestations of an aortic aneurysm.      Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast     ultrasound, coupled with serum biomarker measurements will allow the identification of the     vulnerable aortic wall and patients who are at risk of AAA growth or rupture.   "
96549|NCT02022423|"     With the aging of the American population, the numbers of adults with peripheral arterial     disease (PAD) will increase significantly over the next several decades. Patients with PAD     are at increased risk for morbidity and mortality including both cardiovascular and all-cause     mortality. While regular physical activity reduces risk for vascular events and is     recommended for treatment of PAD patients, few patients meet recommended goals. Exercise     programs which increase long-term adherence to walking can be an important contribution to     PAD treatment. Our Internet-based intervention, with an online community builds on a walking     enhancement program developed by members of our team and is shown to improve adherence among     patients with vascular disease such as coronary artery disease (CAD). Using a randomized,     controlled trial study design, we propose to test an automated Internet-based walking program     with a social media component, to improve long-term adherence to walking while increasing     walking distance, and health-related quality of life, among patients with PAD. Participants     will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an     Internet-based walking program, 3) a combination of telephone counseling and Internet-based     walking program, or 4) a usual care group. The Internet-based walking program with a social     media component has been shown to increase both adherence to walking and overall walking     duration in populations with chronic complex conditions such as CAD and diabetes. There is a     strong need to develop interventions, easily generalizable to a real-world population, to     improve the reach of lifestyle interventions which result in improved physical function and     adherence to regular exercise among complex medical patients. High risk patients such as     those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.   "
96550|NCT02022410|"     The purpose of the study is to prospectively evaluate patients who underwent total knee     arthroplasty (TKA) using the Cumulated Ambulation Score (CAS)   "
96551|NCT02022397|"     General anaesthesia mandates artificial ventilation and tracheal intubation in order to     provide patients with artificial breathing. Difficulties related to ventilation and     intubation remain the leading cause of morbidity and mortality in general anaesthesia,     essentially due to inaccuracies in pre-operative detection of anatomical factors predisposing     to difficult airways. In this project investigators will develop image and video-processing     technologies software solutions to allow automatic recognition of anatomical features playing     a key role in identification of difficult ventilation and intubation, leading to     modifications in pre-operative anaesthesia management assessment and therefore increase     patients' safety.   "
96720|NCT02020369|"     The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate     dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the     treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor     VIII/IX   "
96553|NCT02022371|"     The purpose of this study is to carry out very detailed genetic testing on prostate cancer     cells. The reason to do this is because researchers do not fully understand        -  How prostate cancer develops        -  Why some cancer cells spread and others do not        -  Why some cancer cells respond to treatment and others do not      Researchers and doctors know that 1 in 3 of the male population over the age of 50 has cancer     cells in their prostate. However, most of these men will never know they have it and it will     not affect their quality of life or their life expectancy. However, some cancers can be     aggressive. These are more likely to spread outside of the prostate and cause problems.     Doctors do not have an accurate way to tell the difference between aggressive cancer and     those which will not cause any problems. Even within one prostate some tumours are aggressive     and others do not cause a problem during the lifetime of a patient. In fact, even within one     tumour, different cells may behave differently. In other words, one part of the tumour may be     aggressive and spread, whilst another part of the same tumour does not. This project will try     to find out more about what makes different tumours and different parts of the same tumour     aggressive or harmless.      It is important to find out what makes some cancer cells spread and others stay where they     are. For the investigators to do this they need to collect fresh samples of cancer tissue     from the prostate and from different areas of a tumour within the prostate. This is because     biopsies used to diagnose or exclude cancer by the hospital laboratory are not good enough to     give investigators detailed genetic information. These biopsies have been put into a chemical     called formalin which reduces the quality of the genetic information.      Investigators are therefore asking patients who are undergoing prostate biopsies as part of     their normal care to allow them to take additional biopsies for the purpose of this study.     This may be the first time patients are having biopsies. Or, patients may be having biopsies     after treatment that has been given for the cancer and the doctors are concerned the     treatment is not working.   "
96554|NCT02022358|"     Methotrexate is one of the most effective chemotherapy drugs in the treatment of osteosarcoma     and some other types of bone sarcoma which are treated the same way as osteosarcoma. However,     it frequently leads to sore mouth, tummy pain and increased risk of developing infections.      The investigators try to save or rescue normal cells from the side effects of methotrexate     by giving a drug called folinic acid. Folinic acid is started 24 hours after methotrexate and     given regularly until methotrexate levels are really low and not dangerous to normal cells     anymore. Despite this rescue, side effects are still a problem and many patients are not well     enough to receive subsequent chemotherapy on time. Almost half of the planned chemotherapy     cycles are not given on time due to methotrexate side effects.      In this study the investigators will examine if adding a drug called glucarpidase to folinic     acid is helpful. Glucarpidase is an enzyme that inactivates methotrexate in the blood stream.     Lower methotrexate concentration in the blood stream leads to fewer side effects. The     investigators would like to see if glucarpidase helps patients to have their chemotherapy on     time, by reducing the side effects of methotrexate.   "
96555|NCT02022345|"     To evaluate the introduction of Percutaneous Coronary Intervention without Onsite Surgery in     the largest state, California (CA) began a pilot PCI program in 6 hospitals without onsite     cardiac surgery and then compared the PCI results in the pilot hospitals with results in 120     non-pilot hospitals. The pilot program qualification incorporated appropriate planning and     rigorous hospital, operator, patient, and lesion selection criteria.   "
96556|NCT02022319|"     Background: The main goal of diagnosing thyroid nodules is to differentiate the few malignant     from the large background of benign lesion. Currently available pre-operative tests are     unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary.     Therefore there is a need to develope the available diagnostic tools for the pre-operative     diagnostic work-up of thyroid nodules.      The study will investigate a novel ultrasonographic technique called Shear Wave Elastography     (SWE) in the pre-operative evaluation of thyroid nodules.      Hypothesis:      1) SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and     intra-observer reliability and day-to-day variation.      The study will be conducted as part of a larger PhD study, and an evaluation of the     diagnostic value of thyroid SWE will be evaluated in a larger study.      Perspectives:      An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can     reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the     economic and surgical resources.   "
96557|NCT02022306|"     This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD)     study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy     subjects.   "
96558|NCT02022293|"     Patients with head and neck cancer who underwent irradiation have a higher risk of developing     severe carotid stenosis, and eventually develop to transient ischemic attack or stroke.     However, it's still not clear whether early intervene in vascular risk factors is benefit for     patients after radiotherapy.      Our study aimed to evaluate the feasibility and safety of atorvastatin for preventing NPC     patients after radiotherapy from severe carotid stenosis. In a randomized, double-blind,     placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled     from six centers in Guangdong Province and randomized 1:1 to atorvastatin group or placebo     group.   "
96559|NCT02022280|"     In this randomized controlled crossover study, the investigators propose to test the     hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric     dimethylarginine (ADMA), which is a marker of endothelial dysfunction. The authors propose to     evaluate ADMA concentrations and vascular function analysis in healthy volunteers and adults     with a history of cardiovascular disease given PPI vs placebo for four weeks each.   "
96560|NCT02022267|"     Patients with clubfoot treated with the Ponseti method from a prospective database are     evaluated using gait analysis including a foot model and a disease specific instrument score     and compared to a group of healthy children.   "
96561|NCT02022254|"     This trial is conducted in Europe and Asia. The aim of the trial is to investigate the     influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of warfarin and     pharmacokinetics of metformin in healthy subjects.   "
96562|NCT02022241|"     Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte     maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian     hyperstimulation syndrome (OHSS) in high-risk patients.      However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH)     level post trigger with single injection of GnRH agonist, which might be related to the     shorter duration and lower amount of LH induced by GnRH agonist.      Our aim is to study repeated injection of GnRH agonist for preventing OHSS and maintaining     clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH     antagonist protocol.   "
96634|NCT02021305|"     Purpose So far anatomical abnormalities (mostly congenital) were, in the majority of the     patients, associated with urinary track infections. In this study the researchers will try to     investigate the role of TLRs as molecular interactions between bacterial virulence and host     response.      TLRs are important mediators in the development of the natural immunity against bacteria.     They recognize microbial pathogen associated molecular patterns and alert the host's immune     system to the presence of invading microbes   "
96563|NCT02022228|"     Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte     maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian     hyperstimulation syndrome (OHSS) in high-risk patients.      However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH)     level post trigger with single injection of GnRH agonist, which might be related to the     shorter duration and lower amount of LH induced by GnRH agonist.      Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for     preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled     ovarian stimulation in GnRH antagonist protocol.   "
96564|NCT02022215|"     The purpose of the study is to determine the safety and efficacy of high and low strength of     ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.   "
96565|NCT02022202|"     The purpose of this research study is to better understand the reasons why or why not breast     cancers are destroyed by standard chemotherapy. This information will be used to develop new     and better cancer therapies.   "
96566|NCT02022189|"     This study is being done to obtain pathology reports from all patients in the Dent disease     registry who have had a kidney biopsy. The investigator will collect the biopsy slides and     reports in an attempt to determine if they have any common findings.   "
96567|NCT02022176|"     The purpose of this study is to determine the effects of sodium nitrate on resting metabolic     rate, glucose uptake and formation of reactive oxygen species in humans.   "
96568|NCT02022163|"     A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging,     placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2     intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy     adults, 18-60 years of age.   "
96569|NCT02022150|"     Ascites is a frequent complication of liver cirrhosis, initial treatment consists on     diuretics intake, however, as the disease progresses this complication becomes more severe,     consequently other therapeutic options are used.      Paracentesis is indicated when severe ascites is present and it should be accompanied by     albumin infusion.      Nutritional status is generally affected in patients with liver cirrhosis, even more patients     with severe ascites show decreased energy intake due to gastric compression.   "
96570|NCT02022137|"     As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans     have shown prebiotic effects, and have shown to improve function of the digestive system,     control and induce glycemic effect satiety. Therefore the impact of the fermentation of such     prebiotic in the gut may contribute to improving health and quality of life of patients with     MHE.   "
96571|NCT02022124|"     Patients will be randomized to receive open-label (honestly described placebo) immediately at     baseline or be eligible to receive the open-label treatment three weeks after the baseline     measurements. Therefore all patients will be eligible to receive open-label placebo treatment     for their chronic low back pain during the course of the study.   "
96572|NCT02022111|"     To provide better care and preventive services for people with both depression and diabetes,     the investigators propose to develop and test whether interventions to reduce depressive     symptoms can be integrated into routine diabetes clinics in India. The investigators will     gather feedback from patients in India through focus group discussions and individual     interviews so they can culturally-adapt a model of combined depression and diabetes care. The     investigators will then evaluate the effectiveness and costs of this care model in a trial at     three diabetes clinics in India. It is expected that results from this study can guide how to     incorporate mental health care into routine diabetes clinics in low-resource settings.   "
96573|NCT02022098|"     The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become     common, particularly in the treatment of cancer. Because traditional trials are designed to     evaluate one agent at a time, the evaluation of therapies in combination requires specialized     trial designs. In place of the traditional separate phase I and II trials, this trial uses a     single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of     combination dose levels, and select the optimal combination dose.      Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and     radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and     neck cancer. The trial begins with an initial period of dose escalation (Phase I) to     investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in     combination with CRT.      Using the MTD determined in the Phase I portion, the randomized phase II trial in 94     participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to     evaluate the efficacy and safety of Debio 1143.   "
96574|NCT02022085|"     The rationale behind this post-market clinical follow-up investigation is to collect data     regarding the usability and clinical performance of the Baha Attract System in subjects with     hearing impairment that are candidates for Baha surgery:        -  to evaluate the efficacy of the Baha Attract System in terms of hearing performance          compared to the unaided situation and compared to a pre-operative test situation using          the sound processor on a Baha Softband;        -  to evaluate the mid- and long-term safety of the Baha Attract System.   "
96575|NCT02022072|"     Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of     this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory     vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital     capacity (VC) according to pathology and severity of pulmonary damage of patients with     neuromuscular diseases. The methodology consists in realize VC by support of     inspiratory/expiratory pressures, while the patient is passive and realizing a maximal     inspiratory/expiratory effort simultaneously, with the aid of mechanical     insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and     the non-inclusion criteria are those for an insufflation. The study hypothesis is that long     term insufflation/exsufflation device use could improve thoracopulmonary mobility.   "
96635|NCT02021292|"     Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for     treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).   "
96636|NCT02021279|"     The primary objective of this study is to assess the safety and effectiveness of MatriStem     Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ     prolapse. Patients are evaluated throughout a 3 year follow-up period.   "
96576|NCT02022059|"     Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT)     is although a common act. Unfortunately, this procedure can be painful. Also, many patients     will need many NGT re-insertion. Therefore, the investigators need to increase the     acceptability of this procedure by increasing comfort during NGT passage. Professionals     guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP     (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using     local anesthesic without ordering their use. However, NGT tube insertion is often put without     pre-medication in the face of an accumulating body of evidence indicating that local     anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these     studies have been done in the emergency room with NGT of a bigger gauge and for many reasons     except enteral nutrition.      The investigators primary objective of this prospective monocentric study is to evaluate the     efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before     NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary     objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of     NGT insertion using Likert scale, numbers of try, time of procedure, complications like     tracheal insertion and success of the insertion using thorax x-ray.      The study will be held in CHU Nice at nutrition unit support. After signed consentment,     patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B     (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes     before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at     the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient     will have to answer a questionnaire. Pain will be grade using visual analogue scale     immediately after the procedure. Demographic data and complications will be note by the     investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be     34 patients by group. If the investigators find a benefit, this can change their practice and     guidelines.   "
96577|NCT02022046|"     Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan.     Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric     oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase     inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as     a methylation biomarker.      In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may     affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor.     S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase     (MTHFR), a folate metabolism enzyme can regulate methylation pathway.      The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene     methylation can serve as biosignature to predict CVD in children with CKD children.   "
96578|NCT02022033|"     The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity     as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a     better regimen in the adjuvant setting for patients with resected pancreatic cancer. This     protocol will obtain preliminary data on safety and disease-free and overall survival     following administration of FOLFOX-A for patients with resected pancreatic cancer.   "
96579|NCT02022020|"     This study is being conducted to collect data on the management of gastrointestinal and     urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran     etexilate.   "
96580|NCT02022007|"     The objective of the present proposal is to compare the clinical, endocrine and metabolic     effects of therapy with combination saxagliptin and metformin to saxagliptin and metformin     monotherapy in women with PCOS and prediabetic hyperglycemia (IFG, IGT or IFG/IGT).     Saxagliptin is an oral dipeptidyl peptidase IV (DPP-4) inhibitor whose mechanism of action is     to prolong the duration of blood glucagon-like peptide (GLP-1) and glucose-dependent     insulinotropic polypeptide (GIP) levels by inhibiting their degradation and thereby     augmenting insulin secretion. This study will serve as a pilot investigation to open     perspectives for future studies to explore the potential of combining anti-diabetic drugs     with different mechanisms of action in in patients with PCOS and impaired glucose regulation     (IGR), especially ones for whom standard treatment with metformin is less effective.   "
96581|NCT02021994|"     The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with blood     pressure monitor device.      The cuff range is as follows:      15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm   "
96582|NCT02021981|"     This quality improvement project is focused on improving hypertension care delivery processes     in ambulatory clinical practices, 5 in Illinois and 5 in Maryland for a total of 10 practice     sites.The primary aim of this quality improvement project is to improve blood pressure     control among patients receiving routine care for hypertension in a diverse group of     ambulatory clinical practices. A secondary aim is for American Medical Association (AMA) and     Johns Hopkins Medicine (JHM) quality improvement staff to figure out the best way to help     clinical practices in achieving improved blood pressure control, including working to     increase the use of home blood pressure monitoring.   "
96583|NCT02021968|"     Dengue viruses can cause dengue illness ranging from a mild illness to life-threatening     disease. The purpose of this study is to evaluate the protective effectiveness of a dengue     virus vaccine in healthy adults.   "
96584|NCT02021955|"     This clinical trial is designed to determine whether an intervention that provides     information to primary care providers about gaps in care for their patients recently     discharged from hospital for COPD can reduce hospital re-admissions and mortality and improve     their patients' quality-of-life.   "
96585|NCT02021942|"     This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230     LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka     II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The purpose     of this trial is a proof of concept.   "
96586|NCT02021929|"     The main purpose of this clinical trial is to determine the safety and effects of the study     drug, sorafenib, in adults diagnosed with hepatopulmonary syndrome (HPS). The study will     evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood     and the function of the lung vessels.   "
96587|NCT02021916|"     To provide appropriate collection, storage, and distribution of specimens and medical data to     local investigators who have approved IRB protocols for their specific research purposes.   "
96637|NCT02021266|"     This is a single patient expanded access protocol to investigate the effects of a second dose     of facilitating cell-enhanced hematopoietic stem cell product.   "
96721|NCT02020356|"     The primary purpose of the protocol is to demonstrate that the use of music therapy may make     it possible to discontinue at least one of neuroleptic treatment in patients with AD or     related symptoms complicated by behavioral disorders such as agitation and aggressiveness     evaluated using the Neuropsychiatric Inventory (NPI).      The study hypothesis is that music therapy may have a positive impact on patients with AD     complicated by behavioral disorders by reducing the intensity of oppositional behaviour and     aggressiveness and allowing a diminution of neuroleptic treatment.   "
96588|NCT02021903|"     Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's     disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It     is a major complain and represents a socially relevant problem as unintended episodes of     sleep can also occur while driving for example. Arterial hypotension is frequently observed     in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness     is known to occur preferentially when patients are having arterial hypotension whatever the     cause (i.e. postprandial period, administration of hypotensive medication such as dopamine     agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness.     We have observed this association in an on-going epidemiological survey Hyperglycaemia     induced by oral glucose load - a standardized model simulating food intake during a meal -     provokes arterial hypotension in the majority of Parkinson's disease patients with     dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated     by this fall in blood pressure.   "
96589|NCT02021890|"     to test the metabolic and clinical effects of a 6-month program of dancing in subjects with     type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units.     Self-selection of the leisure time activity program was allowed to increase adherence to the     physical activity programs.   "
96590|NCT02021877|"     Adult patients, age ≥ 18 years, with clinically diagnosed mild, moderate or severe brain     trauma will be asked to participate in the study. This prospective database will consist of     400 subjects with TBI, 200 from both TUCH and Cambridge Addenbrooke's Hospital. In addition,     100 controls will be recruited, with 50 from both centres.This study is a prospective     clinical observational study with detailed data collecting. All patients will be treated     according to the accepted, standardized, existing guidelines that are based on national and     international recommendations. New treatment interventions will NOT be evaluated during the     data acquisition for this study.   "
96591|NCT02021864|"     -  Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D          will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and          25(OH)D less than 30ng/ml will be entered to study. .        -  Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe          preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios,          parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive          and immunosuppressive drugs.        -  Participants will randomly assigned in to two groups of intervention and control groups          .Randomization will be done by random number generator. Intervention group will receive          weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing          elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily          prenatal multivitamin.        -  At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during          study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length,          weight, head circumference ) will be compared between two groups.   "
96592|NCT02021851|"     Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The     incidence can be as high as 80 percent in high-risk patients. Investigators designed this     randomized, double- blind, single-center study to compare the efficacy of the combination of     dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic     surgery.      Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years     patients scheduled for laparoscopic surgery were included in this study. Anesthesia was     induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen /     air mixture in all patients. Remifentanil was continuously infused during surgery. Patients     were randomly divided into two groups. Patients in the dexamethasone and aprepitant group     (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia     and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the     dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to     aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the     last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of     anesthesia.      PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The     blindly evaluated primary outcome was complete response. The secondary outcomes were     incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid     consumption within 24 hours after surgery. Statistical analyses were performed using     Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered     statistically significant.Investigators hypothesized that the antiemetic efficacy of the     aprepitant and dexamethasone combination is superior compared with ondansetron and     dexamethasone combination following the laparoscopic surgery.   "
96593|NCT02021838|"     In collaboration with the National Institute of Justice (NIJ) and the Office for Violence     Against Women (OVW) the Yale University team will evaluate the implementation process and     impact of the U.S. Department of Justice's Domestic Violence Homicide Prevention     Demonstration Initiative. This evaluation seeks to draw critical findings and potential     lessons from the combined experience of the sites including: 1) how the models work in     different communities; 2) the barriers and facilitators to implementing the models; and 3)     outcomes of the model delivery. The evaluation team will also disseminate the findings with     the goal of informing replication.   "
96594|NCT02021825|"     The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2     years. Dosage was adjusted according to side effects. Neurological assessment including the     determination of the Expanded Disability Status Scale (EDSS) score and ophthalmologic     evaluations were performed every 3 months and during relapses. Flow cytometric analysis,     brain and spinal cord MRI was performed at baseline, 6, 12, 18, and 24 months.   "
96595|NCT02021812|"     The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic     Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta     (DTA)   "
96596|NCT02021799|"     The purpose of this study is to determine whether a difference exists in the gut, oral,     vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy     and obese pregnant women. In addition, the investigators are setting out to determine if a     micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of     under-nourished pregnant women.   "
96597|NCT02021786|"     This study aims to evaluate the effects of a mobile phone-based dietary and physical activity     intervention on body fatness, dietary intake and physical activity of preschoolers   "
96598|NCT02021773|"     The purpose of the study is to determine whether monthly subcutaneous administration of     LBR-101 is safe and provides migraine prevention in patients with chronic migraine.   "
96662|NCT02020941|"     This phase II trial studies how well carfilzomib works in treating patients with multiple     myeloma in first relapse or refractory to first-line therapy. Carfilzomib may stop the growth     of cancer cells by blocking some of the enzymes needed for cell growth.   "
96599|NCT02021760|"     -  Trial objective: To test the hypothesis that remote per-postconditioning in connection          with primary PCI will reduce myocardial infarct size patients with STEMI.        -  Trial Design: Placebo controlled randomized study with parallel groups        -  Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at          risk determined by Cardiac Magnetic Resonance (CMR) day 4-7        -  Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium          at risk determined by CMR at 6 months.        -  Global left ventricular function determined by left ventricular ejection fraction          determined by CMR.        -  Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular          volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day          180.        -  Safety Parameters: Major adverse cardiovascular events.   "
96600|NCT02021747|"     Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers     to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization     towards a distinct phenotype associated with impaired host defense function against Mtb and     that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage     (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.   "
96601|NCT02021734|"     There are certain categories of diseases which are more prevalent in the Arab world due to     increased rates of consanguinity in relatively isolated populations. The goal is to discover     these mutations by using next-generation human genetics tools.   "
96602|NCT02021721|"     Hypothesis: To identify new gene mutations that can be related to patients with idiopathic     male factor infertility.      Primary Objective: To detect possible genetic abnormalities in families with more than one     sibling with male infertility.      Secondary Objective: To evaluate using next generation DNA sequencing in cases of infertility   "
96603|NCT02021708|"     The purpose of this study is to learn about the effects of smoking shisha on the lungs, when     compared to the effects of smoking cigarettes or of not smoking. The investigators hope to     learn more about how shisha smokers should be monitored and treated once diseased.   "
96604|NCT02021695|"     With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the     investigators intend to measure the changes in DNA methylation and gene expression in blood     monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are     persistent or can be reversed by improving diabetes control.   "
96605|NCT02021682|"     Alzheimer's disease (AD) is the most common cause of dementia and currently has no disease     modifying treatments or simple accurate diagnostic tests. The goal of this project is to     study how amyloid-beta (a protein thought to cause AD) is made, transported and cleared in     the human body. Better understanding of these processes may lead to improved understanding of     AD, earlier diagnosis and a way to evaluate treatment.   "
96606|NCT02021669|"     The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to     determine whether antidepressant augmentation with two grams of EPA omega-3 per day is     superior to antidepressant therapy alone for major depression in patients with coronary heart     disease (CHD).   "
96607|NCT02021656|"     The primary objectives of this study are to evaluate the efficacy, safety and tolerability of     treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in     treatment-naive and treatment-experienced participants with chronic genotype 1 Hepatitis C     Virus (HCV) infection.   "
96608|NCT02021643|"     This study will evaluate the safety and efficacy of sofosbuvir+ribavirin (RBV), +/- pegylated     interferon, in treatment-naive and treatment-experienced adults with chronic genotype 1, 2, 3     or 6 HCV infection.      The study will be conducted in China, Hong Kong (HK), Korea, Taiwan, and Vietnam.     Participants will be enrolled in the study for 12, 16, or 24 weeks of treatment.   "
96609|NCT02021630|"     This proposal is designed to examine the impact of bariatric surgery on the health of     patients and their families. The shared environment of spouses/cohabitating partners suggests     that patients' families are exposed to the extensive diet and lifestyle changes required of     patients following bariatric surgery.   "
96610|NCT02021617|"     -  To evaluate infusion flow rates attainable when using the proximal humerus and proximal          tibia IO vascular access sites.        -  To evaluate the intraosseous infusion physiology when using the proximal humerus and          proximal tibia IO infusion sites.        -  To further evaluate the relationship between IO and venous blood when used for          laboratory testing.        -  To determine the time from IO needle insertion to IO access established.   "
96612|NCT02021591|"     The main hypothesis of this research is that use of an informatics intervention for     problem-solving in diabetes management, Mobile Diabetes Detective (MoDD), by individuals with     type 2 diabetes will lead to positive improvements on a number of primary and secondary     outcomes related to their health and their management of diabetes. The primary outcomes are a     reduction in individuals' glycolated hemoglobin (HbA1c), improvement in their problem-solving     abilities, and self-care behaviors. Secondary outcomes include a reduction in individuals'     fasting blood glucose (BG); improvement in individuals' self-efficacy, and in emotional     aspect of living with diabetes. We hypothesize that primary and secondary outcome effects     will be sustained at three months and twelve months. Exploratory outcomes include a decrease     in individuals' Cardiovascular Risk (Body Mass Index, Blood Pressure, Total, low-density     lipoprotein (LDL) and high-density lipoprotein (HDL) Cholesterol levels, and Framingham     Cardiovascular Risk Score). We also hypothesize that improvements in clinical outcomes     (HbA1c, fasting BG and Cardiovascular Risk) will be mediated by the improvements in     problem-solving abilities and self-efficacy.   "
96614|NCT02021565|"     The CG ASSIST Project is a four-year study for older Veterans with transfer impairments and     informal caregivers. CG ASSIST is an in-home training program for dyads designed to teach     Veterans how to safely, skillfully, and (when possible) independently perform Activities of     Daily Living involving transfers. Experts (OTs) who provide this training will also     recommend, provide, and install assistive technology devices such as grab bars, bed rails,     and toileting aids as needed. Research assistants conduct home visits with the dyads pre and     post intervention to determine the effects of the program on Veteran and caregiver quality of     life measures (burden, depression, task efficacy, lifespace).      Half of the couples in this study will receive the training from the expert remotely through     a tele-video conferencing device. Research assistants will bring the device to participants'     homes and assist in the training session.   "
96615|NCT02021552|"     The specific aim of this is to establish a cohort of severely injured patients admitted to     our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from     3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms     (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest     risk for developing complicated sepsis and death.   "
96616|NCT02021539|"     The hypothesis tested is that the physical changes associated with cervical ripening result     in a detectable decrease in rigidity. The main objective of this study is therefore to     determine whether the measured elastographic rigidity of cervical tissues in addition to     cervix size can be used to predict delivery within the next 48 hours (creation of a     prognostic score).   "
96617|NCT02021526|"     This is a single-site, open-label, phase II trial of C7, a food supplement or medical food,     for the development of treatment outcome measures for glucose transporter type I deficiency     (G1D). The primary outcome measures are: 1. Safety and tolerability of C7 as measured by     changes in comprehensive blood work, including lipid and free fatty acid panels,     self-reported side effects and clinical exam; 2. Changes in brain metabolic rate by MRI and     EEG measurements during C7 treatment; and 3. Maintenance of ketosis in G1D patients on     ketogenic diet, as measured by serial ketone levels during treatment initiation.   "
96618|NCT02021513|"     This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus     and lupus nephritis patients. We propose to recruit and consent SLE patients who will be     randomized to either receive the study drug, an over the counter fish oil supplement, or a     placebo that contains olive oil. They will have a baseline metabolomic profile (blood test),     nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI     lupus disease activity assessments completed at the time of study medication distribution.     Once 6 months of either the study drug or placebo is completed, then pill counts, assessments     of experience/adherence (including side-effects, adverse effects, complaints, and     un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and     metabolomic profile will be assessed. The study duration for each patient will be 6 months     from initiation of the study drug. It is hypothesized that patients receiving the fish oil     supplement will have improvement in their metabolomic profile. Additionally it is     hypothesized that patients receiving the fish oil supplement will have improvement in disease     activity, fatigue, and quality of life assessments.   "
96619|NCT02021500|"     A study to collect survival data on patients previously enrolled in Abraxane pancreatic     cancer study CA046.   "
96620|NCT02021487|"     The study aims to investigate the presence of a substance in the blood called prokinecitine,     which is released by the heart when a heart attack occurs. Several venous blood samples at     the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the     concentration of this substance in the blood. The usefulness of this new blood marker is     going to be determsined to seek if it would be of help to better diagnose or estimate the     gravity of heart infarction after a heart attack.   "
96621|NCT02021474|"     This is a prospective multi-center, randomized, double-blind, two treatment period,     placebo-controlled study in subjects with migraine headache requiring prophylactic treatment.     The patients will be randomized to receive either histamine dihydrochloride sc or placebo     (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures will be     assessed at selected dosing segments during the 16 week treatment phase and 4 weeks (week     20), 8 weeks (week 24) after the last Injection.   "
96622|NCT02021461|"     The purpose of this study is to investigate the taste preference in children of 3 different     flavours of the ESL oral suspension.   "
96623|NCT02021448|"     Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict     the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects   "
96624|NCT02021435|"     1. Research background           - High blood pressure is one of the most important risk factors to cardiovascular          diseases (CVDs). Reducing population blood pressure can control CVD incidence and lower          mortality effectively. Much research has proven that adjusting for Na and K intake level          can reduce blood pressure. According to the China Salt Substitute Study, the systolic          blood pressure of intervention group which used salt substitute is 5.4 mmHg lower than          that of control group. Life expectancy in Tibet is 67 years old. It is estimated that          the use of salt substitute among population in Tibet can reduce total mortality in Tibet          by 20%. China Salt Substitute Study in Tibet (CSSS-Tibet), found that salt substitute is          effective in lowering both systolic and diastolic blood pressure and offers a simple,          low-cost approach for hypertension control among Tibetans in China (unpublished          results). However, the study focused on hypertensive patients, the effectiveness of          hypertension control by providing free salt substitute to the entire population remains          unknown, and a large-scale trial is needed.        2. Objectives           - Primary objective is to observe the effect of providing salt substitute on population          blood pressure in Tibet. Secondary objective is to observe the effect of such          intervention on population mortality, cardiovascular mortality and life expectancy. In          addition, the data collected from high-risk population (sub-group) in the study will be          used in China Salt Substitute and Stroke Study (SSaSS). Also, serum cholesterol and          random blood glucose of people over 60 in Tibet will be collected.        3. Method             -  The study is a open, cluster-randomized, controlled trial.             -  30 villages with 15 to 35 households each and a distance of at least five               kilometers in between will be selected from Damxung county and Maizhokunggar               county. The two counties have an average altitude of over 4000 meters in Tibet               Autonomous Region.             -  All selected villages will be randomly assigned to intervention group or control               group on a 1:1 ratio.             -  All household in the selected villages will be recruited if they meet the               eligibility criteria. Approximately 4,500 participants will be enrolled             -  Intervention group receives free salt substitute. Control group will continue to               buy their own normal salt. Both group will receive the same health education on               salt reduction.        4. Outcome - Primary outcome is blood pressure. Secondary outcomes include total mortality,          cardiovascular disease mortality, life expectancy, serum cholesterol level of people          over 60, and random blood glucose level of people over 60.   "
96625|NCT02021422|"     The study's overall objectives are to evaluate the safety of anakinra in combination with     standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as     to collect preliminary immune modulation and clinical activity information, overall survival,     and serious adverse events related to the study drug.   "
96666|NCT02020889|"     The purpose of this randomized, double-blind study is to investigate the efficacy and safety     of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared     with placebo over a 52-week study treatment period in subjects with relapsing or refractory     Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy     including background corticosteroid therapy with or without immunosuppressive therapy. During     the treatment period, in accordance with standard of care, corticosteroid dose will be     tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as     Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day     prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid     requirement.   "
96626|NCT02021409|"     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a     general term that means that the kidneys are not functioning to their full potential. The     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to     produce erythropoietin.      The purpose of this study is to find out if the study drug, a tablet taken orally, is safe     and effective for the treatment of anaemia associated with chronic kidney disease.      The study will enroll 120 patients at multiple locations in Europe, Asia and Australia.     Participation will involve a screening visit and between 12 and 15 study visits scheduled     over a period of approximately 5 to 7 months. The estimated total duration of study treatment     will be 16 weeks. During these scheduled visits patients will undergo a number of procedures     to confirm efficacy and safety of the study drug, including measurement of heart rate and     blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for     laboratory tests.      The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this     research.   "
96627|NCT02021396|"     The main objective is to show that splenic embolization improves salvage rate one month in a     population of splenic trauma patients closed with a high risk of hemostasis of splenectomy   "
96628|NCT02021383|"     Investigators are conducting a randomized controlled trial with overweight and obese college     students on the University of Minnesota campus. The primary outcome will be weight loss     measured 12 months after study enrollment (corresponds to 10 months after the end of     treatment).   "
96629|NCT02021370|"     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a     general term that means that the kidneys are not functioning to their full potential. The     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to     produce erythropoietin.      The purpose of this study is to find out if the study drug, a tablet taken orally, is safe     and effective for the treatment of anaemia associated with chronic kidney disease.      The study will enroll 120 patients at multiple locations in Europe, Asia and Australia.     Participation will involve a screening visit and between 12 and 14 study visits scheduled     over a period of approximately 5 to 7 months. The estimated total duration of study treatment     will be 16 weeks. During these scheduled visits patients will undergo a number of procedures     to confirm efficacy and safety of the study drug, including measurement of heart rate and     blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for     laboratory tests.      The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this     research.   "
96630|NCT02021357|"     The project aims to assess the effects of treatment proprioceptive through the use of     hyperboloid on the intensity of pain, muscle activity, severity and joint mobility in     subjects with TMD. Treat will be a blind randomized clinical trial. Will be recruited     volunteers aged between 18 and 40 years, with myofascial pain and arthralgia according to the     Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly     divided in two different groups, the first group constituted by treatment with hyperboloid     associated with the exercise of proprioceptive tongue on the hard palate and the second     group consists of treatment with hyperboloid. The Treatment protocols will be applied for 12     sessions, the volunteers will be evaluated in three stages: before applying the treatment,     immediately after the first session and after the last session   "
96631|NCT02021344|"     Most college students with mental disorders do not receive treatment, and over 80% of those     who die by suicide have never made contact with campus mental health services. Knowledge,     stigma, and other health beliefs represent significant barriers to help-seeking for many of     these students. However, there have been no large-scale intervention studies for reducing     these barriers to mental health treatment on college campuses. This project will fill this     gap by determining whether a community mental health education program, Mental Health First     Aid (MHFA), is an effective method to increase number of students who seek mental health     services on college campuses. MHFA is an international, 12-hour training program that has     been shown to increase knowledge of mental illnesses and their treatments, decrease stigma,     and increase helping behaviors in community members. However, it has not been tested in a     college setting in the United States. To determine the effectiveness of MHFA in US colleges,     the proposed project will involve a randomized control trial of the MHFA training program on     32 campuses representing a range of higher education institutions, from community colleges in     rural areas to research universities in large, urban areas. The MHFA training program will be     administered to peer supports such as residential advisors. Administrative data from campus     mental health services and pre- and post-intervention surveys will be used to collect outcome     data on service utilization, knowledge, attitudes, and other measures. Data analyses will     focus on identifying changes in students' behaviors, knowledge, and attitudes toward mental     illnesses that can be attributed to the MHFA training. In addition to testing a novel and     timely mental health intervention for college students, this project will result in improved     data collection measures for college populations, and will lay the foundation for stronger     connections and future collaborations between diverse campus communities. If the MHFA program     is successful in reducing stigma and increasing general on-campus awareness and early     treatment of emerging mental health problems, then it may provide a cost-effective means for     enabling more students to seek early treatments for developing mental health problems.   "
96632|NCT02021331|"     The purpose of this study is to compare two different techniques of placing dental implants:     1) removing the tooth and placing the implant immediately and 2) removing the tooth and     placing both the implant and a temporary crown immediately. Both procedures currently are     accepted methods for replacing missing teeth but direct comparisons of the two procedures are     lacking. The results of this study should aid clinicians in selecting the best implant     placement technique for their patients.   "
96633|NCT02021318|"     This study is conducted to explore a new therapy for anemia in patients with chronic kidney     disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which     contains iron) is important for the transport of oxygen in your blood. The purpose of the     study is to see if Roxadustat is effective and safe to treat anemia in patients with chronic     kidney disease. Roxadustat will in this study be compared to darbepoetin alfa, a commercially     available medicine for treatment of anemia (tradename Aranesp).   "
97133|NCT02014792|"     Studies suggest that dietary omega-3 fatty acids influence the extent to which the time     interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated     with increased risk of sudden cardiac death (SCD). The purpose of this research is to     investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid     levels in patients who have recently commenced haemodialysis.   "
96638|NCT02021253|"     Surgical resection is one of the curative treatment modalities for HCC. Limits are     postoperative septic and liver functional complications related to an increase in bacterial     translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and     bacterial degradation products from the intestine to the portal circulation. The endotoxemia     secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO).     NO is also a potent inducer of membrane instability, responsible for an increase in the     permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a     worsening of bacterial translocation.      Probiotics are live microorganisms which when administered in adequate amounts, provide a     health benefit on the host ((Health and Nutritional Properties of Probiotics in Food     Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data     from experimental and clinical literature show a significant effect of probiotics on the     improvement of liver function and a decrease in infectious complications in patients with     chronic liver disease. The proposed study would evaluate the effect preventive and     therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic     inflammation promotes postoperative complications.   "
96639|NCT02021240|"     Low dose sub-anaesthetic dose of ketamine has been shown to reduce postoperative pain and     analgesic consumption. However, due to the heterogeneous results, the standard dosing regimen     has not been available. Recently, its effect in postoperative outcomes and the development of     post-operative surgical pain has also been suggested.      Ketamine has been shown to reduce post-operative early inflammation especially serum IL-6.     Therefore, study in its effects in post- operative pain and outcomes due to inflammation is     suggested. Only few clinical studies assessed post-operative pain are related to     inflammation.      Pain after third molar surgery is a good model of postoperative acute inflammatory pain.      A previous study showed that there was no benefit to administer ketamine before or after oral     surgery for pain relief. However, other studies demonstrated that ketamine used as sedative     or local ketamine in third molar surgery could reduce postoperative dental pain, swelling and     trismus.      Postsurgical facial oedema is difficult to quantify accurately as it is three dimensional.     Over the years, various measurement techniques have been tried to measure oedema objectively.     These include direct linear measurement using tape or flexible rulers across fixed soft     tissue landmarks, standardized stereophotographic measurements, computerized tomography (CT),     magnetic resonance imaging (MRI), ultrasonography (US) and three - dimensional (3D) laser     scanning. Recently, three dimensional image reconstructions using a reversed engineering     technique has been developed and is used in the manufacturing industry. This technology could     be applied in a clinical setting for monitoring soft tissue changes.      In this study, the investigators will aim to study the use of sub-anaesthetic dose of     ketamine in post-operative dental pain and recovery outcomes.      The investigators hypothesise that post-operative pain after Bilateral Third Molar under     General Anaesthesia is less in patients receiving sub-anaesthetic does of ketamine before     incision. The magnitude of this effect will be compared with a positive control group     (dexamethasone) as well as a placebo group (normal saline). Further, the investigators aim to     demonstrate whether ketamine can reduce post-operative facial oedema and other post-operative     outcomes.   "
96640|NCT02021227|"     The occurrence of an acute respiratory failure necessitates mostly admission to ICU and     mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for     the majority of patients. Many reasons may contribute to weaning , extubation failure and     prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV,     may represent a main factor and early rehabilitation may reverse these conditions and improve     the success of weaning from MV.The objective of this study is to evaluate the effect of an     early chair sitting (while the patient is awake but still mechanically ventilated) on weaning     from mechanical ventilation and ICU mortality.      Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV     for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule:     the studied group (20 patients): chair-sitting group will be transferred from bed to arm     chair for at least 1 hour and once a day; the control group will stay in bed until     extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality,     ICU length of stay are assessed and compared between groups. Expected results: Early chair     sitting would decrease MV duration, number of extubation failure, nosocomial infections and     ICU mortality. Feasibility and safety of this intervention will also be evaluated and also     the related work load.   "
96641|NCT02021214|"     In the present study, investigator will investigate the effects of methylphenidate (40 mg) on     mPFC activity in healthy male volunteers during fear extinction using functional magnetic     resonance imaging (fMRI). Additionally, investigators will examine the effects of     methylphenidate during aversive interoceptve arousal. The present study will help to identify     brain structures and networks involved in anxiety and will give insights for methylphenidate     as a possible adjunct to behavioral therapy for patients with anxiety disorders. Further,     this study may provide important information about the possible use of fMRI to help the     development of drugs for the treatment of anxiety disorders.   "
96642|NCT02021201|"     This comparison is made between the effects of sertindole and risperidone on vulnerability     indicators in schizophrenia. More specifically: the effects of these two antipsychotic     compounds on basic processing of incoming information is studied. The investigators expect     that the newer antipsychotic sertindole to be more effective in restoring information     processing in schizophrenia patients than risperidone.   "
96643|NCT02021188|"     This VISION study aims to investigate the role of inflammation in atherosclerosis using 68Ga-     DOTATATE PET, and to validate 68Ga-DOTATATE PET imaging for the detection and quantification     of vascular inflammation in the aorta, coronary and carotid arteries. This study will test     the hypothesis that in subjects undergoing carotid endarterectomy for symptomatic plaques,     there will be a positive correlation between carotid artery 68Ga-DOTATATE PET signal and the     underlying degree of carotid inflammation measured by immunohistochemical analysis.   "
96663|NCT02020928|"     Setting: Oral mucositis is a very common complication of cancer treatment, accounting, often     at increased risk for infections and even the interruption of treatment, interfering with the     prognosis of the disease. The low intensity laser therapy has been proposed as an alternative     for the treatment and prevention of this side effect, with good results in terms of clinical     and functional, speeding up the process of wound healing and reducing pain.      Objective: To evaluate the effectiveness of using low power laser in the prevention of oral     mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow     transplantation.      Methods: There will be a Clinical Trial Randomized, double-blind study to evaluate the     effectiveness of using low power laser in the prevention of oral mucositis in patients with     hematological cancer, undergoing chemotherapy for bone marrow transplantation. Participate in     the study, patients who are in the condition mentioned above accepting participate and have     aged over 18. Will be excluded from the study patients who have autoimmune disease, which     present sensitivity to laser or who have already started treatment for oral mucositis prior     to this study.The study variables are:-independent variable: whether or not the red laser of     low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy regimen,     type of blood cancer. For determining the association between the independent variable and     the dependent will be used chi-square tests of association (Pearson) and Fisher's exact test,     if necessary. Will calculate the risk ratio (RR) as a measure of relative risk, with the     confidence interval at 95% (IC95%).Also be calculated NNT (number needed to treat to obtain     benefit) and NNH (number needed to harm getting). Will be adopted a significance level of 5%.     The project was approved by the Ethics and Research iMIP. All patients will be appropriately     informed about the objectives of the project and will only be included if they voluntarily     agree to participate by signing the consent form.      Keywords: laser, prevention and control; oral mucositis, bone marrow transplant.   "
96644|NCT02021175|"     Cigarette smoking remains the leading preventable cause of morbidity and mortality in the     United States. In Los Angeles, rates of morbidities due to cigarette smoking follow     prevalence. While the rate of cigarette smoking in Los Angeles County among youth is at     historic lows, prevalence is not uniform: Cigarette smoking is pervasive among residents who     have significant economic disparities. Prevalence is also among the highest in the world for     Korean school-aged youth and substantially higher numbers of Korean American youth smoke     cigarettes. To date, smoking prevention efforts in Korea have had mixed results as they are     not interesting to youth and are not interactive.      This project will assess an interactive, culturally adapted, tailored smoking cessation     intervention delivered through the internet and cell phone. Using technology, the     investigators seek to increase the reach and access of our intervention and facilitate     cessation without in-person sessions, a factor that limits smoking cessation interventions     for youth. Youth are energetic users of electronic media, lending support to the delivery of     treatment through technology.      The investigators predict that subjects assigned to the intervention will demonstrate     statistically higher rates of smoking abstinence and longer retention in the cessation     program compared to those assigned to the standard of care condition. Subjects reporting     higher levels of smoking exposure, lower motivation, poor mental health, disadvantaged     neighborhoods, and lower levels of acculturation to American culture will also have lower     quit rates at each follow-up visit.   "
96645|NCT02021162|"     This study aims to assess the effect of Gilenya on brain pathology and cognitive impairment     over 6, 12, and 24 months in patients with relapsing MS using MRI, clinical data, and     neurological assessments. Healthy controls will also be followed over 6, 12, and 24 months     using the same measures.   "
96646|NCT02021149|"     According to the 2005 National Comorbidity Survey-Replication study, approximately 20.9     million American adults, or 9.5 percent of the population over the age of 18 suffer from mood     disorders including major depressive disorder, chronic, mild depression and bipolar disorder.     Major depressive disorder (MDD) is predicted to be the second leading cause of disability     worldwide by the year 2020; sub-clinical mood disturbances impact many additional people and     are a major reason people seek psychotherapy services. The economic burden of depression in     the United States is significant: $83.1 billion in 2000 and increasing. Much of this burden     comes from the high rate of sub-optimal treatment outcomes associated with the disorder.     Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate treatment, and     up to 20% of patients will fail to adequately respond to all currently available     interventions. Moreover, current treatments come at the cost of significant central nervous     system (CNS) side effects, further highlighting the need for more effective treatments with     fewer side effects. To address these pressing clinical issues, the investigators will conduct     a placebo controlled, clinical trial to determine if Whole Body Hyperthermia (WBH) enhances     the effects of psychotherapy compared to psychotherapy alone in medically healthy patients     with moderate to severe mood disorders. The investigators plan to recruit a sample of 24     medically healthy individuals with mood problems who will be randomized to examine whether     WBH enhances the effects of psychotherapy. To determine acute and sustained effects of WBH     +psychotherapy on mood disorders, the study will include basic psychiatric     questionnaire-based assessments at three therapy sessions prior to a single session conducted     while receiving one of two intensities of WBH treatment. Subjects who elect not to conduct a     therapy session in the WBH chamber will still be able to complete study questionnaires at all     therapy sessions. This study challenges the existing paradigm by determining if peripheral     afferent sensory pathways can be accessed to enhance the treatment of mood disorders and thus     avoid problems of exposing all of the brain to non-selective drugs.   "
96647|NCT02021136|"     The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace +     standard treatment versus standard treatment alone in terms of last 24-hour pain relief after     6 weeks. in patients with medial knee osteoarthritis.   "
96648|NCT02021123|"     Because anidulafungin is generally well tolerated and appears to have limited interaction     with other drugs, it is a potential important agent in the treatment of invasive fungal     infections. Although anidulafungin is approved for the treatment of invasive candidiasis in     adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese     patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as     well as other echinocandins) in this specific patient population is still largely unknown.     During endoscopic gastric bypass surgery, patients are more prone to various kinds of     infection, justifying the prophylactic use of anidulafungin in this specific cohort of     patients.      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic     gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard     anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be     compared to the pharmacokinetics in a normal-weight group.   "
96649|NCT02021110|"     Rationale: Polycystic liver disease (PLD) is a rare disorder characterized by >20     fluid-filled hepatic cysts. Polycystic livers are present in the combination with renal cysts     as a manifestation of autosomal dominant polycystic kidney disease (ADPKD), or isolated in     the absence of renal cysts as autosomal dominant polycystic liver disease (ADPLD or PCLD).     PLD patients are confronted with symptoms caused by the mass effect of their polycystic liver     every day for the rest of their life. There is no standard therapeutic option for symptomatic     PLD patients. Current options are fairly invasive or their efficacy is only moderate.      Preliminary data in our research lab have shown that ursodeoxycholic acid (UDCA) inhibited     the proliferation of polycystic human cholangiocytes in vitro through the normalization of     the intracellular calcium levels in cystic cholangiocytes. The investigators also found that     daily oral administration of UDCA for 5 months to PCK rats, an animal model of ARPKD that     spontaneously develops hepato-renal cystogenesis, resulted in inhibition of hepatic     cystogenesis.      The investigators hypothesize that UDCA is an effective therapeutic tool in reducing liver     volume in PLD.      Objective: First, to demonstrate whether UDCA-therapy is effective in reducing total liver     volume in PLD patients. Second, the investigators want to assess if UDCA modifies quality of     life. Finally, the investigators want to assess safety and tolerability.      Study design: International, multicenter, randomized, controlled trial Study population: 34     subjects (18 ≤age ≤ 80 years) suffering from symptomatic polycystic liver disease with     underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts on CT-scan and liver     volume of ≥ 2500. Symptomatic is defined as ECOG-PS ≥ 1 and having at least three out of ten     PLD symptoms.      Intervention: The patients will be randomized (1:1) into two groups. One group of patients     will receive 15-20mg/kg/day UDCA for 24 weeks. The other group will receive standard care.      Main study endpoint: Proportional change of total liver volume in UDCA treated patients     versus non treated patients, as assessed by CT at baseline and 6 months.      Main secondary outcome variables:        -  To demonstrate whether UDCA-therapy changes absolute total liver volume        -  To demonstrate whether UDCA-therapy changes gastro-intestinal symptoms measured by a          GI-questionnaire        -  To demonstrate whether UDCA-therapy changes quality of life as measured by SF-36        -  To demonstrate which proportion of patients has any reduction in total liver volume          after 24 weeks        -  To demonstrate whether UDCA is well tolerated        -  To demonstrate whether UDCA-therapy changes absolute total kidney volume (TKV).   "
96650|NCT02021097|"     The purpose of this study is to evaluate the contraceptive efficacy and safety of an oral     contraceptive containing a combination of LNG 100mcg/EE 20mcg compared to LNG 150mcg/EE 30     mcg.   "
96664|NCT02020915|"     Ultrasound guided placement of the knife intersphincteric increases accuracy and safety     during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is     divided.   "
96665|NCT02020902|"     This is a post-marketing surveillance study on a marketed cetrizine hydrochloride     formulation.   "
97172|NCT02013297|"     The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic     radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.   "
96651|NCT02021084|"     Colchicine is the drug of choice to treat patients with Familial Mediterranean Fever (FMF ),     some of the patients treated with colchicine may suffer from gastrointestinal (GIT) adverse     effect such as diarrhea and abdominal pain especially in the higher dose.      5-10% of the patients with FMF that have been treated with colchicine may have partial or no     response to this therapy.      Aim of our study: the aim of our study is :.1to evaluate the efficacy of probiotics in     reducing the number of adverse effect in patients with FMF that are being treated with     colchicine and suffering from GIT adverse effect.      .2 To evaluate the efficacy of probiotics in reducing the number of FMF attacks in children     with FMF that has been treated with colchicine with only partial response.      Methods: the study will be done among children (5-17 years old) with FMF that are currently     followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that     are being treated with colchicine and suffering from either GIT adverse effect or partial     response to colchicine.      The study is design to be double blind placebo control, in the first 3 month patients will be     with no therapy and will be required to record all there FMF episodes and their GIT adverse     effect, in the second period the patients will be randomly divided into two groups 1.patients     that will received placebo (group 1) and the 2. Probiotics group - patients will received     probiotics (Bio -25 including 11 types of bacteria L.acidophilus, B.bifidum , L.rhamnosus,     L.lactis, L.casei, B.breve, B.thermophilus, B.longum, L.paracseis, L.plantarum, B.infantis),     both for three month, during this period patient will be required to record their     gastrointestinal symptoms and other symptoms that may be related to FMF.   "
96652|NCT02021071|"     Philips Healthcare has added a virtual path planner to the current commercially available     XperGuide software platform and that has the potential to significantly reduce dose during     image-guided needle interventions.   "
96653|NCT02021058|"     Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula     on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding     intolerance   "
96654|NCT02021045|"     There is increasing evidence that renal replacement therapy (= continuous veno-venous     hemodialysis) generates cerebral microembolism which is detectable on transcranial Doppler     ultrasound.      The aim of this study is to monitor patients with transcranial Doppler under two conditions:     during hemodialysis and in a hemodialysis-free interval (in each period cerebral embolic load     is detected during 30 minutes).      The study hypothesis is that during hemodialysis the cerebral embolic load is significantly     higher than in the hemodialysis-free interval.   "
96655|NCT02021032|"     The primary objective of the post-marketing study is to collect safety and effectiveness data     for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information     will be used to evaluate the occurrence of any long-term side effects from the treatment. The     collection of long-term effectiveness data on subjects treated with Prolieve® will provide     information on the long-term effects of treatment and time to re- treatment (any treatment     initiated for BPH since Prolieve' treatment, including a second treatment with Prolieve).   "
96656|NCT02021019|"     Sympathetic activation is a hallmark of end-stage renal disease and adversely affects     cardiovascular prognosis. Hypertension is present in the vast majority of these patients and     plays a key role in the progressive deterioration of renal function and in the exceedingly     high rate of cardiovascular events. Selective catheter-based renal denervation has been shown     to be safe and effective in attaining improved and sustained blood pressure control in     patients with resistant hypertension and normal renal function. The investigators hypothesize     that catheter-based renal denervation is a safe and effective intervention to achieve     sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive     End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular     outcomes.   "
96657|NCT02021006|"     The exact role of urinary tract infection in the appearance of chronic kidney disease is     unclear. Children with congenital malformations of kidney and urinary tract have the higher     risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can     reduce the risk of urinary tract infection in children with these malformations, this study     will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B     will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic     prophylaxis reduce the risk of urinary tract infections in these children and if urinary     tract infections influence the appearance of renal damage.      Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral     reflux and that urinary tract infections, in morphologically normal kidneys, will not result     in chronic renal failure.   "
96658|NCT02020993|"     There is a need for a biochemical marker in addition to clinical condition which will help     the physician to understand the clinical progress of the disease.      Urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not     been evaluated for respiratory distress in newborn.      The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory     diseases in newborns by a controlled trial.   "
96659|NCT02020980|"     The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections     in relieving pain, in a broad population of patients who suffer pain as the primary problem     associated with spasticity. Thus, this study will help to expand the information that is     available regarding the impact of BoNT-A treatment in routine clinical practice conditions.      Treatment goals can vary greatly from one patient to another and there is no unique, single     outcome that reflects the treatment benefits in all the cases. Therefore, this study with     special focus on the achievement of therapeutic goals, will allow the identification of each     patient's specific goals regarding the improvement of the functional outcomes, the quality of     life and patient well-being.   "
96660|NCT02020967|"     The primary objective of the protocol is to define percentage of patients with acromegaly in     relation to the total number of screened patients with confirmed clinically significant set     of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I,     Growth Hormone, Oral Glucose-Tolerance Test [IGF-1, GH, OGTT]) and instrumental examination     methods (Magnetic Resonance Imaging [MRI]).   "
96661|NCT02020954|"     The purpose of this study is to determine whether electrocardiogram, echocardiography,     cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and     clinical outcome.   "
96701|NCT02019394|"     To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady     state   "
96667|NCT02020876|"     This clinical utility study pilot is based on a review of real but de-identified and     randomized patient cases and aims to evaluate Urologists' treatment recommendations before     and after reviewing the results provided by the Decipher test. This is a pilot study and the     primary intent is to help guide development and design of future clinical utility studies for     Decipher   "
96668|NCT02020863|"     The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid     administration system to deliver fluids using feedback from standard operating room     hemodynamic monitors. In standard anesthesia care the rate of IV fluid administration to the     patient is determined by the anesthesiologist caring for the patient. In this study protocol,     the rate of fluid administration will be determined instead by the closed-loop (automated)     control system under the supervision of the anesthesiologist. The system will independently     decide when to give fluid and at what rate; the supervising anesthesiologist will monitor the     system to ensure appropriate volumes are being delivered and to intervene if necessary.   "
96669|NCT02020850|"     The Toe-Brachial Index (TBI) that has been using in our laboratory is 0.6, but the average     value we measured in normal individuals is about 1.0, furthermore, we can not find out the     reference of TBI that is currently being used. The purpose of this study is to determine the     more accurate value of TBI and Ankle-Brachial Index (ABI). In this study, all participants     will be required to fill out a demographic questionnaire before the blood pressures test. All     participants will have their toe, ankle and brachial systolic blood pressure measurements to     obtain the TBI and ABI.   "
96670|NCT02020837|"     This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of     postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous     micro-anastomosis in the distal arm will result in the reduction of volume and improvement in     quality of life of patients with post-mastectomy lymphedema   "
96671|NCT02020824|"     Virtual reality is currently used as a therapeutic strategy in common phobia as agoraphobia     or acrophobia, since it permits to have a better control (on occurrence of events or on the     environment) during the therapy than in in vivo therapy. Our hypothesis here is that we can     improves the therapeutic effects of the virtual exposure by giving control to acrophobic     patients during their exposure.   "
96672|NCT02020811|"     The study will evaluate the functionality of IMMAGES , an intravenous infusion device system,     in patients hospitalized in Bait Balev hospital. The study will aim to determine how the     IMMAGES system integrates within IV infusion therapy regime and what are the advantages and     disadvantages, if any, of using this system within the prescribed setting.   "
96673|NCT02020798|"     The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.   "
96674|NCT02020785|"     Phosphorus-based food additives are commonly used by food manufacturers for many     applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these     additives can significantly increase an individual's daily phosphorus intake, little is known     about the effect of dietary phosphorus on kidney health. In this study, the investigators     will first lower baseline phosphorus intake to about 1000mg/d by educating participants to     avoid foods with phosphorus additives. Then, participants will be randomized to a higher     phosphorus period (~2gm/d) and a lower phosphorus period (~1gm/d) by providing unaltered,     commercially-available food/beverage products with and without phosphorus additives.      The investigators hypothesize that participants will have higher urine albumin excretion and     fibroblast growth factor-23 during the higher phosphorus period compared to the lower     phosphorus period.   "
96675|NCT02020772|"     Patients who suffer from musculoskeletal pain often have more than one diagnosis. These     patients mostly have to wait a long time for the doctor's examination and treatment, and they     also often have a sick leave for a long period of time. The investigators expect that     treatment and follow-up by an coordinating interdisciplinary team can improve these patients     opportunity to function, increase their quality of life, and decrease their pain. The purpose     of this study is to investigate if use of a coordinating interdisciplinary team in primary     health care will result in reduced sick leave compared with practice as usual, and give fewer     referrals to specialized health services and private rehabilitation centers. Research data     will be obtained from the patients journals, questionnaires, and clinical examinations..   "
96676|NCT02020759|"     Neurological complications are frequent during extracorporeal membrane oxygenation (ECMO)     representing a crucial factor for patient outcome. However, to date there is no consensus     with regard to optimal neurological monitoring of patients undergoing ECMO.      The aim of this study is to monitor patients using transcranial Doppler (TCD) ultrasound and     near-infrared spectroscopy (NIRS) during ECMO therapy.      The study hypothesis is that TCD and NIRS technology are sufficient tools to detect cerebral     embolism and hypoperfusion during ECMO therapy.   "
96702|NCT02019381|"     Recently two distinguished committees, Institute of Medicine (IOM) and The Endocrine Society     have proposed different intake guidelines for Calcium and Vitamin D. We wish to compare the     effects of both of them on calcium metabolism and bone turnover. We propose a one year     randomized double blinded study for the same.   "
96703|NCT02019368|"     This is a randomized, double-blind, placebo controlled, crossover study to determine the     antioxidant effect of aged garlic extract. This study will also compare the oxidative status     in heavy smokers with that in non-smokers.   "
97173|NCT02013284|"     The purpose of this study is to determine a relationship between a person's flora/bacteria in     their gut (the intestinal microbiome) and their risk of cardiovascular disease. Investigators     will look at inflammatory markers in the blood and also look at the genome of the bacteria in     the gut.   "
96707|NCT02019316|"     BioSteel Sports Drink (BSD), a proprietary blend of branched chain amino acids, taurine, and     B vitamins, has increased its popularity among professional and amateur athletes. BioSteel     claims that BSD attenuates muscular and mental fatigue, and enhances recovery when consumed     before and during intense exercise. To date, the efficacy of BSD on attenuating muscular and     mental fatigue, and enhancing recovery during repeated bouts of intense exercise is unknown.     In a blind crossover study, participants will be subjected to sprint interval exercise     followed by muscular and cognitive function testing under two conditions: BSD and     isoenergetic control.   "
96677|NCT02020746|"     The main objective of this study is to assess the safety and the efficacy of EscharEx in     preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower     extremity ulcers and traumatic/post operative wounds.      This study will be a multi-center, assessor blinded, randomized, controlled study intended to     demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control     treatment in patients with hard to heal wounds.      72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound     (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between     5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled     into the study.      Patients will undergo a 1 week screening period (2 visits) which will include: record of     demographics, medical history and concomitant medications, vital signs, physical examination,     clinical laboratory tests, wound photography and assessments and questionnaires (wound status     and quality of life). During this period wounds will be treated by standard treatment per the     decision of the physician. During this screening period, subjects whose study wound size     (surface area) decreases by more than 20 percent will be excluded. Following completion of     the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle     debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10     applications or until complete debridement is achieved, whichever occurs first. In stage 2     (24 patients): Treatment will be performed for up to 8 applications or until complete     debridement is achieved, whichever occurs first. Following each application the wound will be     washed, photographed and assessed for wound size, removal of nonviable tissue and change in     granulation tissue (by digital planimetry software), wound status, and safety parameters.     Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline     gauze (except when successive 24h or 48h treatments are performed, in the second stage).     Following completion of the debridement treatment period, patients will be treated according     to standard procedures and evaluated (wound assessments) once a week until complete wound     closure for up to 12 weeks from last application (up to 12 visits). Only during the first     stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits)     follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will     be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For     patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For     patients enrolled at the second stage, if wound closure was achieved at the 12 weeks     follow-up, additional visit will be performed 2 weeks later to confirm wound closure.   "
96678|NCT02020733|"     The aim of this study is to compare the metal cannula routinely used in our clinical practice     with intrauterine hysterosalpingography catheter as a probable alternative device in a     prospective, single-blinded, randomized study.   "
96679|NCT02020720|"     This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission     tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such     as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.   "
96680|NCT02020707|"     This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized     nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma that     cannot be removed by surgery or with cancer of the cervix, endometrium, ovary, fallopian tube     or peritoneal cavity. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading.     Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by     targeting certain cells. Giving paclitaxel albumin-stabilized nanoparticle formulation and     bevacizumab may kill more tumor cells.   "
96681|NCT02020694|"     Hypovitaminosis D is highly prevalent in the general population, particularly in obese     individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved     in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it     has been reported that individuals with low vitamin D levels are at increased risk for     cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of     cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of     these lifestyle interventions. The purpose of this study is to assess whether vitamin D     supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile     of overweight/obese subjects to a greater extent than diet alone.   "
96682|NCT02020681|"     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the     treatment of early buccal carious lesions compared to placebo.   "
96683|NCT02020668|"     Despite leading cause of morbidity, treatment strategies for Rheumatic diseases are geared     almost exclusively toward medical-pharmacological area away from offering the patient the     possibility of an interdisciplinary approach to their disease.      Present study test whether treatment of physiotherapy reduces stiffness and pain inherent in     rheumatic disease and improve their quality of life related to health.   "
96684|NCT02020655|"     Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin     and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas     exposed to pressure, shear and friction. Shear- force is an important contributing factor and     wound dressing are possibly capable to reduce shear force at the skin. At this moment there's     no good marker to detect the effect of shear- force at the skin. A potential marker could be     cytokines (IL-1α) which are released after mechanical loading of the skin. A previous study     have shown a significant increased level of IL-1α after the application of pressure. We want     to investigate if these cytokines are significant increased after the application of shear-     force at the skin.      Objective: The objective of this study is to gather knowledge about cytokine concentrations     (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to     use this knowledge in the future to investigate if different prophylactic wound dressings are     capable to reduce shear force at the skin. This could be interesting in the prevention of     pressure ulcers.      Study design: With the use of a special developed shear- force model are we going to     administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy     volunteers for 30 minutes. As a control we ware going to put the shear- force model at the     other arm without the application of shear- force. Before the use of the shear- force model     we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb     cytokines from the skin. After the use of the shear force- model we will perform cytokine     measurements again. Then we will extract the cytokines from the Sebutape with the use of     ELISA.      Study population: 10 Healthy volunteers Age 18- 30 years      Primary outcome: IL-1 α concentration (pg/ml)   "
96685|NCT02020642|"     The purpose of this study is to investigate the effect of renal transplantation on fluid     overload and its consequence on the severity of obstructive sleep apnea, in patients with end     stage chronic kidney disease. It aims further to investigate the relationship between     overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.   "
96686|NCT02020629|"     In hypoglycemia, there is a counterregulation to restore glucose levels. An important part of     this counterregulation is the release of the hormone glucagon. Since the GLP-1 receptor     agonist lixisenatide has been shown to be associated with a low risk of hypoglycemia, this     study examines whether lixisenatide affects the glucagon response to hypoglycemia.   "
96687|NCT02020616|"     The purpose of this study is to investigate the safety and effectiveness of the study drug     known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be     given in different doses as an injection under the skin. The study is expected to last up to     6 months for each participant. Participants may remain on stable-dose metformin as prescribed     by their personal physician.   "
96688|NCT02020603|"     Endoscopic high-frequency soft coagulation is available for the management of bleeding or     nonbleeding visible vessels during endoscopic submucosal dissection. However, its efficacy on     peptic ulcer bleeding has not been elucidated so far. The aim of this study was to evaluate     the efficacy of hemostasis with soft coagulation using hemostatic forceps by comparing it     with argon plasma coagulation (APC) in a prospective, randomized trial.   "
96689|NCT02020590|"     Fracture healing is a complex physiological process caused by interaction of cellular     elements, cytokines and signaling proteins, which results in the formation of new bone. There     is for now no universally accepted approach to evaluate the progression of fracture healing.     Typically, a fracture is considered as a delayed-union when the bone has not united within a     period of time that would be considered adequate for bone healing. Delayed-union suggests     that union is slow but will eventually occur without additional surgical or non-surgical     intervention, whereas non-union is defined as the cessation of all reparative process of     healing.      The incidence of impaired healing is estimated to range from 5 to 10% of all long bone     fractures, depending on the fracture site, the type and degree of injury, among other     factors. Currently the treatment of choice remains bone allograft or autograft. This     procedure shows in general good results but requires an invasive surgery of several hours     under general anesthesia, followed by a few days of hospitalization. Because of this, major     complications have been reported in up to 20-30% of patients.      The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a     proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union     fractures of long bones. In this study, delayed-union is defined at the time of screening as     an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset     of the fracture.   "
96690|NCT02020577|"     The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of     dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will     involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous     histology, recurrent/ metastatic squamous cell carcinoma of head and neck and other advanced     solid tumours (except sarcomas).   "
96691|NCT02020564|"     The purpose of this research study is to investigate the effectiveness of a technique     designed to improve processing speed (i.e. the amount of time it takes to process     information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how     well this technique can help people with TBI increase their processing speed and their     ability to function better in everyday life.   "
96692|NCT02020551|"     Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol     and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested     whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.   "
96693|NCT02020538|"     This primary aim of this study is to test the impact of a strategy of perioperative     chloride-restriction through intravenous (IV) fluid therapy on the incidence of acute kidney     injury after cardiac surgery.      A prospective, open-label, single-centre 4-period sequential study of varying strategies of     perioperative IV fluid composition will test the hypothesis that a perioperative protocol for     the administration of chloride-poor intravenous fluids compared to chloride-rich intravenous     fluids will reduce the incidence of AKI after adult cardiothoracic surgery.   "
96694|NCT02020525|"     -  We have previously reported the results of the primary and secondary outcomes of a          randomized study aiming to investigate the impact of a restrictive transfusion protocol          on the magnitude of reduction in blood transfusion in a typically mixed general surgery          population subjected to major abdominal surgery.        -  The main finding of that study was a reduction in red blood cell usage with the          implementation of a restrictive transfusion regimen. This was achieved without adversely          affecting clinical outcome in the population studied.        -  The aim of this secondary analysis performed on a subgroup of 20 patients from the          original study was to determine whether there are any differences in the postoperative          immunologic response, as expressed by the production of inflammatory mediators, between          a restrictive approach to red cell transfusion and a more liberal strategy.   "
96695|NCT02020512|"     This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma     and ocular hypertension.   "
96696|NCT02020499|"     This is a long term study to evaluate common therapeutic algorithms and possible predictive     parameters for Somatuline Autogel treatment in patients with Acromegaly.   "
96697|NCT02020486|"     This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment     Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the     clinical study ward the day before starting the study drug administration (Day -1) for PK and     safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47     (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1),     Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature     water   "
96698|NCT02020473|"     End-of- life care is a major issue in medical ethics with life support technology progress.     Intensive care may prolong the dying process in patients who have been unresponsive to the     treatment already provided. Withholding or withdrawing of life support (WLS) care was     introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult     and affected by several factors including not only disease severity but also ethics,     religion, culture, and legal background. In western countries, advance directives had an     important role to WLS for dying patients and honor patient autonomy. However, the illegality     of advance directives in Korea and Korean culture under Confucianism, requiring children to     do the best to treat their parents in the name of filial piety make physicians and family     members difficult to WLS in terminally ill patients.      Additionally, WLS in intensive care unit had been usually decided without official     documentation before the final legal decision by Supreme Court in Korea. Scanty information     exists about end-of-life practices because informed consents of WLS were taken after the     legal decision.      Thus, we aimed to investigate the current status of informed consent at the time of decision     to WLS and difference between WLS group and non-WLS group in Korea.   "
96699|NCT02020460|"     The study will examine the feasibility of Direct Dorsal Column Stimulation using existing     Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory     evoked potentials (SSEPs), stimulator settings required, improvement in quality of life and     use of pain medications.   "
96700|NCT02019407|"     Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block     in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be     composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with     CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010     expert consensus guideline.   "
96708|NCT02019303|"     To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy     (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed     invasive breast cancer or suspected invasive breast cancer.      Hypothesis: FNA and CNB have equivalent diagnostic accuracies      In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each     consented patient. The two samples will be evaluated separately by different pathologists     blinded to the material in the other sample.      The results of the biopsies will be compared to the gold standard (lymph node excision).   "
96709|NCT02019290|"     This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study     examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy     volunteers.      A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight     fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and     after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be     co-administered on Day 15, after an overnight fast.      Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15     days.   "
96710|NCT02019277|"     This open-label, multicenter, phase IIIb study will assess the safety, tolerability and     efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), subcutaneous (SC)     trastuzumab (Herceptin), and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as     first-line therapy in participants with HER2-positive metastatic breast cancer (mBC). All     participants will be treated with 3-week cycles of pertuzumab IV (840 milligrams [mg] first     dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams per 5 milliliter [mg/5     mL]). The taxane treatment regimen will be determined by the investigator. Participants will     continue therapy until disease progression, unacceptable toxicity, or the participant     withdraws consent, whichever occurs first. Time on study treatment is up to 2 years.   "
96711|NCT02019264|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in     overweight and obese subjects with CV disease and/or multiple CV risk factors.   "
96712|NCT02019251|"     The goal of this study is to evaluate the utilization of conventional 'thermally' polarized     perfluorinated gases mixed with oxygen as inhaled inert contrast agents to image the airway     spaces in subjects who have undergone single or double lung transplantation. This is an open     label study expanding on current work here at Duke. Images will be obtained using 19F MRI     during wash-in and washout for evaluation of ventilation efficiency.   "
96713|NCT02019238|"     Pulmonary vein isolation (PVI) combined with empiric ablation of either common sites of     non-PV triggers of Atrial Fibrillation (AF) and locations that may sustain stable AF sources     should be more efficacious than PVI combined with ablation of only documented non-PV triggers     of AF in achieving long-term arrhythmia control in patients with persistent or long standing     persistent AF.   "
96714|NCT02019225|"     The purpose of the TiME Trial is to determine whether dialysis facility implementation of a     minimum hemodialysis session duration of 4.25 hours (versus usual care) for patients with     end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis has     benefits on mortality, hospitalizations and health-related quality of life.      The trial also aims to demonstrate the capacity to conduct a large, pragmatic clinical trial     in partnership with two large dialysis provider organizations.   "
96715|NCT02020434|"     RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem (RPX2014)to     treat bacterial infections, including those due to multi-drug resistant bacteria.   "
96716|NCT02020421|"     The current standard of care for rehabilitation of patients with aphasia after stroke is     conventional speech and language therapy (SLT). Due to economic realities on most stroke     units, SLT can often not be given with optimal intensity in the first weeks after the stroke.     Developing new adjuvant therapies which may render SLT sessions more effective is thus one     approach to improve rehabilitation outcome. Recent functional imaging studies in post-stroke     aphasia have shown that the recruitment of brain regions in the unaffected hemisphere seems     to be an inferior strategy for recovery of language function as compared to re-activation of     brain regions in the vicinity of the infarct. Non-invasive brain stimulation techniques, such     as repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current     stimulation (tDCS) are new methods to modulate brain activity. Evidence from our own     feasibility study in sub-acute stroke suggests that these new techniques, when applied in     conjunction with conventional SLT, may help to normalize brain activation patterns and might     yield better rehabilitation outcome than SLT alone. With NORTHSTAR, we propose a multicenter     proof-of-concept study to investigate the safety, feasibility and efficacy of these new     non-invasive brain stimulation methods as adjuvant therapies for subacute post-stroke     aphasia.      Our goal is to determine the most effective brain stimulation modality to decrease inhibition     onto the left side of the brain. We will assess if a combination of brain stimulation and     speech and language therapy will improve language recovery. We will quantify language     recovery (expressive and comprehensive skills) using specific tests, commonly used by speech     and language therapists.      We will invite patients recently admitted to the stroke unit of the study centers to     participate in our research project. Once patients consent to our study we will randomly     assign them to one of three experimental groups. For 12 days, all groups of patients will be     setup with brain stimulation during their usual rehabilitation sessions. Two of those groups     (treatment groups) will each receive a different type of brain stimulation (rTMS and tDCS),     in the third group, patients will not receive real stimulation (placebo group). By comparing     the extent of aphasia recovery between groups, we will determine the benefits attributable to     brain stimulation relative to SLT alone.   "
96717|NCT02020408|"     This study will use brain imaging technologies to measure several neurotransmitters     (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our     impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN)     and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to     use a challenge with brain imaging that will stimulate dopamine release which we hypothesize     will generate anxiety rather than pleasure in AN, and will help explain why AN restrict     eating in order to reduce anxiety. This study will help to understand the unique puzzling     symptoms in eating disorders and contribute to finding better methods for identifying     effective treatments for these often relapsing and sometimes chronic disorders.   "
96718|NCT02020395|"     The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide     (GLP)-1 responses to a test meal in lean and obese individuals.   "
96858|NCT02018380|"     Osteoarthritis (OA) is a progressive, chronic disease affecting more than 20 million     Americans. There is no known cure for OA and management includes pain control and prevention     of functional decline.      Purpose: To investigate the immediate effects of a shock absorbing insole (SAI) placed in the     shoe on knee pain, functional mobility and lower extremity biomechanics.   "
96997|NCT02016573|"     This is a study investigating the safety and usefulness of the Renal Denervation Procedure in     reducing high blood pressure in people whose blood pressure is not adequately controlled     despite already being treated with 2 blood pressure lowering drugs. This study is designed to     compare the effects renal denervation to a usual care group.   "
96722|NCT02020343|"     America's preferential consumption of high-fat/high-sugar foods is a driving force in the     current epidemic of obesity and insulin resistance. Recent scientific observations suggest     that the taste of food may play a role in how the body processes the food eaten in a meal.     The intestine may play a central role in all aspects of dietary fat metabolism, from initial     encounter with taste buds in the mouth to eventual triglyceride (TG) storage in the body.      The investigators hypothesize that elevated blood fats in insulin resistance are a result of     elevated intestinal-TG secretion and poor communication of this organ to the rest of the body     after meals.      In this study, meal feeding and sensory studies will be performed to determine whether the     mechanism of taste-associated intestinal signaling leads to higher levels of blood fats after     meals in 24 healthy, insulin resistant and type 2 diabetic subjects. Individuals will consume     special meals the night before the tests and participate in sensory tests in the morning to     analyze the effect of taste.      The goal of this work is to understand how insulin resistance may cause impaired signaling     between the taste buds and the intestine to result in an elevation in blood lipids, which     increases the risk for other chronic diseases. This study will generate data for a future     study to understand how diabetes treatment affects this process.   "
96723|NCT02020330|"     This is a randomised two arm study, comparing artemether-lumefantrine 3 days and 5 days     treatment. Patients will be randomised in blocks of ten to one of the two treatment arms. The     standard regimen is twice daily for three days with a delay of at least eight hours between     the first and second doses. A single of primaquine will be given to all patients on the first     day of treatment for gametocytocidal activity. The initial treatment will be given under     supervision, all other subsequent doses will be given to the patient to the taken at home.     Patients will be followed up for nine visits over forty two days.   "
96724|NCT02020317|"     To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia     alerts during potassium-increasing drug-drug-interactions.   "
96725|NCT02020304|"     The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have     a shorter period of pain relief than that maintained at room temperature. The temperature of     the dose of medication will be measure with an infrared thermometer immediately prior (within     5 minutes) to administration.   "
96726|NCT02020291|"     The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in     the formation and dissemination of tumours. The present project focuses on the critical role     of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer     disease.      WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which     mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby     acting anti-metastatic. The aim of the present clinical phase 1 trial is to establish the     recommended dose for a clinical phase 2 study and thereby further develop Foxy-5 as a first     in class anti-metastatic cancer drug. Foxy-5 is designed to inhibit the development of     metastasis by reducing the motility of cancer cells and should thereby increase the survival     rates of patients with solid malignant tumours.   "
96727|NCT02020278|"     The objective of this trial is to provide 6 months of safety follow-up for children and     adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who have previously     participated in a tolvaptan hyponatremia trial, and to assess the efficacy of tolvaptan in     increasing serum sodium for those subjects who receive optional continuing tolvaptan     treatment of variable duration (up to 6 months).   "
96728|NCT02020265|"     EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols,     Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more     amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in     operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly     developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference     between the groups in regard to their emotion regulation capability will be tested by fMRI     with regard to amygdala activation following EEG-NF LMI as well as two stress challenge     tests.   "
96729|NCT02020252|"     The purpose of this research study is to test a touchscreen computer program, which allows     patients to see information on a computer screen regarding cancer care, and specifically     clinical trials. The purpose of this research is to help the investigators learn more about     how to use technology in the medical setting to improve health outcomes.   "
96730|NCT02020239|"     The investigators goal is to optimise physical activity interventions to help previously     inactive women improve their body shape and composition. Many people seeking to lose weight     or improve body composition initiate an exercise programme. The most common recommendation of     an exercise intervention for someone attempting to manage their weight, has been to     'prescribe' the recommended 150 minutes of exercise per week (World Health Organisation),     often using one mode of exercise. An alternative approach might be to offer a portfolio of     activities, from which the exerciser can pick and choose, to facilitate greater amounts of     physical activity. The problem with this is how do you account for the different intensities     of walking, washing the car, playing badminton, cycling, jogging, etc? In this study, the     investigators will try to overcome this barrier by allocating a number of physical activity     points to each activity. Using this physical activity points system, participants will be     provided with a points target that they can meet using any combination of activities.      The investigators research aim is therefore to compare this points-based system against the     traditional 5x30minute prescription (and sedentary control) for their ability to help     previously inactive women to drop a dress size, increase fat burning, positively change their     body composition and tone their tummy.   "
96731|NCT02020226|"     The Primary objective of this study is:      1. To determine the cardiac safety of TH-302 in patients with advanced solid tumors      The Secondary objectives are:        1. To assess the pharmacokinetics (PK) of TH-302        2. To evaluate whether there is an association between plasma exposure to TH-302 and its          active metabolite, Br-IPM, and effects on cardiac repolarization        3. To assess the safety and antitumor activity of TH-302 in patients with advanced solid          tumors   "
97174|NCT02013271|"     To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long     TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA   "
96732|NCT02020213|"     Invasive Aspergillus infection (IAI) occasionally occurs in immunocompromised people. Except     administrating empirical anti-fungal agent, using objective parameters to support the     tentative diagnosis of an IAI in order to make the anti-fungal treatment more specifically is     also important. At present, serum galactomannan (GM) test is the less-invasive, non-cultural,     and time-saving examination for augmenting a diagnosis of Aspergillosis. It was suggested by     Infectious Disease Society of America (IDSA) 2008 as a screening and monitoring tool for     Aspergillosis , and the cut-off value was adjusted to 0.5 by USA FDA . However, in clinical     practice, GM seems not to have good predicted value even the sensitivity and specificity are     declaimed more than 80% . Other controversial issues include the reproducibility of GM5 and     the effect of piperacillin-tazobactam or other antibiotics on the accuracy of GM baseline In     this study, serum GMs are examined in two conditions, one is collected for establishing a     baseline and the other is collected after piperacillin-tazobactam administration. We hope to     confirm the validity of GM baseline and the effect of piperacillin-tazobactam on GM value in     Taiwan.   "
96733|NCT02020200|"     The purpose of the study is to explore the effect of MPH on working memory, attention and     decision making in adults with BD in remission or in depressed state. The results will be     compared to findings in healthy adults and adults with ADHD. The investigators hypothesize     that MPH will incur improved performance in all measures.   "
96734|NCT02020187|"     Congenital myopathies are clinical and genetic heterogeneous disorders characterized by     skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout     their life. However, progression of symptoms is rare. There are no specific treatments for     congenital myopathies. Training has been shown to benefit several other muscle diseases with     weakness, but the defect in congenital myopathies involves contractile proteins of the     sarcomere, why the effect of training is uncertain in these conditions. The investigators     will therefore investigate the effect cycle-ergometer training for 30 minutes, three times     weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital     myopathy patients, who do not train, will serve as controls for the trained patients. The     study starts and ends with a test day, where efficacy based on VO2max, performance in     functional tests and a questionnaire will be assessed.   "
96735|NCT02020174|"     The purpose of The Preeclampsia Registry is to collect and store medical and other     information from women who have been medically diagnosed with preeclampsia or a related     hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome,     their family members, and women who have not had preeclampsia to serve as controls.     Information from participants will be used for medical research to try to understand why     preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of     new treatments.   "
96736|NCT02020161|"     Therapeutic guidelines for treatment of patients with de novo APL to be used by every     institution that wants to follow them. All patients who are reported may be retrospectively     analyzed   "
96737|NCT02020148|"     The goal of this research study is to understand the relationship between the hormone     oxytocin and postpartum mood. Based on previous research, the investigators hypothesize that     lower plasma oxytocin concentration during pregnancy will predict a greater likelihood of     postpartum depression. Second, it is expected that oxytocin concentration in the third     trimester will show an inverse relationship with the severity of depressive symptoms at 4 - 6     weeks postpartum.      Potential participants in the study will be screened for eligibility during their third     trimester of pregnancy, using a combination of questionnaires. Those who are eligible for     participation will have one blood sample drawn at this time, and then be asked to complete a     follow up questionnaire at 4-6 weeks postpartum to assess for depressive mood symptoms. This     follow up questionnaire can be completed either in person or on the telephone. Anyone who is     interested in receiving help for their mood at any point in the study will receive referrals.   "
96738|NCT02020135|"     PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured     by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane     Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC. Subjects who have     participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator     are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC     2301 extension study. Subjects who are benefiting from treatment may be able to receive up to     an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.   "
96739|NCT02020122|"     To utilize the plasticity of the central pain pathways in order to (i) shift individuals with     a pro-nociceptive pain modulation profile towards an anti-nociceptive one, and (ii) assess     its relevance in minimizing pain-derived morbidity.   "
96740|NCT02020109|"     Retrospective evaluation on the effect of splenic irradiation on clinical and hematological     response and toxicity in patients with chronic lymphatic leukaemia (CLL).   "
96741|NCT02020096|"     Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block     performance. It allows direct visualization of nerve structures, needle guidance in real-time     to the target, and observation of local anesthetic diffusion. Some case series have     demonstrated significantly faster onset time for interscalene blocks, supraclavicular blocks     and axillary brachial plexus blocks under ultrasound than with conventional techniques.     Ultrasound guidance also enhances the quality of popliteal sciatic nerve block at the     popliteal fossa compared with single injection, nerve stimulator-guided block using either a     tibial or peroneal endpoint. Despite this impressive profile, the application of the     ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that     lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is     equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar     plexus block is traditionally performed using surface anatomical landmarks and nerve     stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of its     deep anatomic location and the acoustic shadow of the overlying transverse processes.     Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of the     lumbar paravertebral region with the ultrasound beam being insonated through the     intertransverse space (ITS) and directed medially toward the intervertebral foramen     (PMTS-ITS) may overcome the problem of the acoustic shadow and allow clear visualization of     the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar plexus     blocks has not been studied extensively and its advantages are not validated in a clinical     study. Thus, we designed this prospective, randomized, subject and assessor blinded,     parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar plexus     block combined with nerve stimulation and a conventional technique on time required to     readiness for surgery in patients undergo knee arthroscopy surgery.   "
96742|NCT02020083|"     The purposes of this study are to determine whether transporters expression levels and drug     interaction between TDF and FTC could contribute to modulate the placental transfer of this     drug or. To test this hypothesis, an ex vivo model known as the perfused ex vivo cotyledon     model allows to reproduce the conditions of the third trimester of pregnancy   "
96743|NCT02020070|"     The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab     with degarelix before surgery to remove the prostate, followed by more degarelix and     ipilimumab after the surgery, will have on prostate cancer.      The goal of this trial is to assess the safety and efficacy of a multimodality approach     combining hormones and immunotherapy in prostate cancer populations that are considered     incurable and standardly treated with hormones alone, and represent clinical states prior to     development of castration-resistant disease. There are 2 cohorts. The first will use     ipilimumab and degarelix prior to and following radical prostatectomy in men with newly     diagnosed, oligometastatic, castration-sensitive disease. The second cohort will include men     who have already received definitive local therapy with radical prostatectomy but have since     experienced biochemical and/or metastatic recurrence.   "
96744|NCT02020057|"     To our knowledge, there has been no information on in vivo clinical results of posterior     cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated     whether the clinical and radiographic results, incidence of post fracture of the tibial     polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and     the incidence of osteolysis would be similar between posterior cruciate-substituting total     knee prostheses using conventional and highly cross-linked polyethylene.   "
96745|NCT02020044|"     The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK     and Ultra-thin DSAEK) for corneal transplantation.   "
96746|NCT02020031|"     The purpose of this study is to determine whether or not giving a lower dose of antibiotics     (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing     infection than the current standard dose which is given intravenously (IV) through a wrist     vein.   "
96747|NCT02020018|"     Does a wound vac dressing prevent wound infection after heart surgery?   "
96748|NCT02020005|"     The primary aim of this study is to determine menthol smokers' perception, product     preference, and pattern of use across six products including, mint-flavored nicotine gum;     non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler.     Participants will undergo an orientation and baseline assessment followed by a 2-week product     sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use     during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed     by one week of abrupt withdrawal of the product. This study design was successfully used in a     study we conducted that examined the smokers' preference for a variety or oral tobacco     products.   "
96749|NCT02019992|"     To determine the plasma levels of mtDNA in ICU department patients with and without sepsis     and evaluate their association with severity, systemic inflammation and outcomes. Plasma from     control, septic and severe septic patients will be collected. The level of mtDNA and systemic     cytokine will be measured.   "
96750|NCT02019979|"     Metformin is thought to activate AMP-activated protein kinase (AMPK), a major sensor of     cellular energy levels and a key enzyme limiting cellular growth during times of cellular     stress. Once activated, this enzyme restricts anabolic processes such as protein, cholesterol     and fatty acid synthesis and inhibits mTOR, a protein kinase responsible for unregulated     growth. MTOR is upregulated in a variety of tumors, including NSCLC providing rationale to     take advantage of this pathway with metformin.   "
96751|NCT02019966|"     Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine     (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy.     In Korea, primarily owing to limited subsidization policy in the health insurance system,     many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg     monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients,     rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with     suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available     in Korea for patients who had difficult-to-treat antiviral resistance owing to prior     treatment failures. However, which is the better has not been evaluated yet. A long-term     efficacy and safety of TDF-based rescue therapies in real practice for those patients should     be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near     future.   "
96752|NCT02019953|"     The overall approach to the study is to assess the feasibility of recruiting African     Americans to participate in several health-promoting programs and to compare health outcomes     among the three interventions.   "
96753|NCT02019940|"     This open label study will evaluate the safety and efficacy of riluzole in patients with     PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient,     with a one month follow up at week 16.   "
96754|NCT02019927|"     Transcorneal Electrical Stimulation (TES) using the OkuStim® device delivers electrical     impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the     retina may help to preserve visual acuity and/or the visual field.   "
96755|NCT02019914|"     The purpose of this study is to evaluate the effects of treating Obstructive Sleep Apnea     (OSA) with continuous positive airway pressure (CPAP) therapy on symptoms of post traumatic     stress disorder (PTSD). The study hypotheses are that CPAP use will improve PTSD symptoms     overall and that CPAP use will improve sleep quality and duration, nocturnal symptoms related     to PTSD, mood, daytime sleepiness, sleep-related quality of life, and general health     perception.   "
96756|NCT02019901|"     Purpose: To compare a nurse-led clinic including person-centered care and tight control with     care as usual in patients with rheumatoid arthritis (RA) and moderate/ high disease     activity.      Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high     Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month     randomized controlled study with a 6 month open follow-up. Intervention group (N=60):     Nurse-led visits every 6th week, with structured person-centered care and evaluation of     disease activity. If disease remission is not reached, pharmacological treatment including     both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and     biologics) is modified according to a predefined algorithm. The control group (N=60) is     treated according to care as usual with visits to physician every 6th month. Outcome     measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary     outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue,     sleep and satisfaction.   "
96757|NCT02019888|"     The accurate assessment of auditory status is critical for planning treatment for Veterans     with hearing loss to include medical and audiological management. Current physiologic tests     of auditory function in the standard clinical audiological test battery for Veterans have     limited sensitivity in detecting some middle-ear disorders, and do not include a direct test     of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of     absorbance for improved sensitivity in the assessment of middle-ear function including     acoustic reflex testing. The addition of WB tests of cochlear function included in the WB     test battery provides an opportunity to improve audiological diagnosis of a range of hearing     disorders in Veterans. The automation provided by the WB test battery could provide     additional benefits in reducing the duration of the evaluation, leaving more time for     evaluation of test findings and counseling. Results from this study may lead to the     improvement of audiological care for Veterans with hearing loss.   "
96758|NCT02019875|"     The purpose of this study is to determine whether changes in the activity of the enzyme     CYP3A4 can change the Vitamin D and bone mineral homeostasis.   "
96759|NCT02019862|"     Clinical and radiological 2 years results of TRJ® Hip Stem.   "
96760|NCT02019849|"     Twelve months follow-up of implant survival and clinical and radiological follow-up of     Plasmafit® Cup.   "
96761|NCT02019836|"     Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with     or without accompanying bacteremia in the first month of life which is still an important     cause of morbidity and mortality. Vitamin D is a fat-soluble steroid hormone that primarily     contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In     addition to its classical role in bone metabolism, vitamin D also has immunomodulatory     effects on immune function. Although some studies reported a link between vitamin D     deficiency and critical illness in adults, a direct relationship has not been directly shown     yet. However, to the best of our knowledge, no study evaluated the association between EOS     and maternal/neonatal vitamin D levels. The objective of this prospective study is to     determine the possible role of maternal and neonatal plasma vitamin D levels on EOS     development in term infants. We also aim to evaluate possible effect of the severity of     vitamin D deficiency on EOS development in the study population.   "
96762|NCT02019823|"     General synopsis for SMS-text Adherence Support (*StAR) Study and associated preparatory and     pilot work      Background: High blood pressure is an important risk factor for heart disease, stroke and     chronic kidney disease. Clear evidence exists that for individuals with high blood pressure     (hypertension) lowering blood pressure really reduces this risk. One of the critical factors     in the long term control of blood pressure is the regular use of effective antihypertensive     medications. In South Africa, poor treatment adherence (attending clinic, re-filling     prescriptions, and regularly taking hypertension tablets) is known to be an important and     alterable risk factor for uncontrolled high blood pressure and its complications (heart     disease, stroke and chronic kidney disease). SMS-text messages have been shown to improve     clinic attendance and medication adherence for some diseases (like HIV and TB) in other     low-resource settings. It is not clear whether SMS-text messages to support treatment     adherence have an effect on long-term blood pressure control. The acceptability,     sustainability and scalability such technology also remains to be determined.      Aim: To investigate if a system of SMS-text messages to support treatment adherence is more     effective than usual care for controlling high blood-pressure.      Objectives: The main objective is to test whether advice and support given by SMS-text,     either by providing information (informational) or by allowing a two-way communication     (interactive) improves control of blood pressure at one year compared to usual care.      Additional objectives include assessing whether the interventions have an effect on,        -  Clinic attendance        -  Prescription refill adherence        -  Self-reported medication adherence        -  Hypertension related illness or death        -  Patient empowerment      Study design: Single centre randomized three-arm parallel group trial As it is not clear how     best to support treatment adherence for people with hypertension we need to compare the     different ways this might be done. Eligible patients who provide written consent will be put     into one of three groups and then compared. The groups are selected by a computer which has     no information about the individual (i.e. by chance). Participants in each group will get     different types of SMS-text messages and these are compared.      Study interventions:        -  Enhanced usual care In addition to their usual clinical care participants will receive          the pre-randomisation Welcome to the *StAR Study SMS-text, a Happy Birthday SMS-text          on their date of birth and up to six additional SMS-text messages containing study          specific information and thanking the participant for taking part in the study.        -  Informational SMS-text messages In addition to enhanced usual care, participants          allocated to the informational SMS-text support group will receive semi-tailored          structured adherence-support (including clinic appointment and medication pick-up          reminders, medication adherence support and hypertension-related education.)        -  Interactive SMS-text messages In addition to enhanced usual care and informational          SMS-text messages, SMS-text messages sent to participants in the interactive SMS-text          group will contain a prompt to respond which will guide participants to additional          SMS-text based resources.      Outcome measures: The main outcome measure is mean blood pressure measured at one year.     Additional outcomes include the proportion of participants with controlled blood pressure     as well as measures of clinic attendance, prescription refill adherence, self-reported     medication adherence, hypertension related illness or death, and patient empowerment.   "
96763|NCT02019810|"     Severe traumatic brain injury with increased intracranial pressure can lead to decreased     cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to     bad prognosis. It is not yet established whether increasing cardiac output in these patients     can lead to an increase in cerebral blood flow, although there are some arguments in favor of     this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will     improve cerebral blood flow in patients with severe traumatic injury and high cerebral     pressure.   "
96764|NCT02019797|"     This study examines pharmacological preconditioning and post conditioning of desflurane by     comparing cardiac troponin release in patients receiving either desflurane or propofol for     the aortic valve surgery.   "
96765|NCT02019784|"     Patients with cirrhosis are particularly prone to infection which is frequently a precipitant     of hepatic encephalopathy, renal failure and circulatory collapse. Bacterial infections are     of particular concern in patients with cirrhosis because they are poorly tolerated. Sepsis     and associated endotoxaemia whereby bacteria produce inflammatory particles occur in     approximately 40% of hospitalized patients with cirrhosis and is a major cause of death.      Gut-derived and blood-borne pathogens can induce an inflammatory response within the liver     and spleen, which are the major organs that remove bacteria and their endotoxin (such as     lipopolysaccharide - LPS and bacterial DNA itself) from the bloodstream. Several mechanisms     have been identified and proposed in this process which depends upon a balance between the     barrier functions of the gut and the 'detoxifying' capacity of the liver. People with     established liver cirrhosis have been shown to have escape of endotoxin into the bloodstream     produced by bacteria that reside in their intestines, which becomes more permeable or     'leaky'.      Gut dysfunction is defined by changes in the types of bacteria within the gut and in overall     permeability allowing bacterial products which would otherwise be contained within the gut to     travel into the bloodstream and lymphatic system with detrimental effects elsewhere in the     body. This passage of bacterial products is termed bacterial translocation, and it's effects     on the liver and general immune system can be then be measured.      It has now become recognised that certain types of white blood cells such as neutrophils and     monocytes become dysfunctional and this predisposes to infection and may also have a more     direct pathogenic role in hepatic encephalopathy. Thus neutrophil and monocytes may be a     novel pharmacotherapeutic target in a condition where current therapies such as bowel     aperients (e.g. lactulose) are inadequate. A therapeutic strategy utilising Rifaximin, a     non-absorbable antibiotic, to modulate gut bacterial which produce ammonia, a chemical known     to be important in the cause of hepatic encephalopathy, could potentially lower gut-derived     systemic inflammation, endotoxaemia, infection and organ dysfunction in this population     improving outcomes and prolonging transplant-free survival.      We therefore plan to test if Rifaximin positively affects markers of immune dysfunction in     patients with liver cirrhosis experiencing chronic hepatic encephalopathy after 30 days of     treatment, as our primary research question.      Positive results from this study would support further trials into the potential benefit of     using Rifaximin to improve immune function, as well as reduce the recurrence of hepatic     encephalopathy, in patients with liver cirrhosis.   "
96766|NCT02019771|"     Hypothesis: Men who have sex with men (MSM) are at higher risk for sexually transmitted     diseases. Currently, free testing for sexually transmitted diseases is only being performed     in urine samples. Investigators hypothesize that the rates of both gonorrhea and chlamydia     will be higher when testing includes more than one anatomical site (rectum and oropharynx).      The aim of the study is to estimate the rates of asymptomatic Chlamydia and/or Gonorrhea in     the oropharynx, rectum and urethra (urine) of HIV infected men who have sex with men at the     specialty care center of the University of Nebraska Medical Center and compare to the rates     in Douglas County, using nucleic acid amplification tests.   "
96767|NCT02019758|"     Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose     inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms,     which medication provides a more durable treatment response, and whether biomarkers can     predict treatment response.      Participants: A total of up to 200 16-80 year old patients with a new diagnosis of     eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a     target of 122 randomized.      Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical     trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will     generate data for all three Aims   "
96982|NCT02016768|"     There is a relationship between CSM and hypertension, probably a cause/effect relationship,     and investigators term this type of hypertension cervicogenic hypertension. Abnormally     functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate     and inhibit parts of the central and autonomic nervous systems as part of a chronic stress     response, which causes hypertension and migraine. This theory is now being expanded to     encompass both CSM and essential hypertension, the idea being that these two conditions are     intimately related.   "
96768|NCT02019745|"     Chronic exposure to (cigarette smoke) CS causes biological changes, including airway     remodeling and changes in baseline gene expression profiles at the level of the epithelium.     Our own data indicate that chronic exposure to CS suppresses the ability of epithelial cells     to enhance antiviral gene expression in response to influenza infection and activate host     defense responses. While there is a large body of evidence supporting the notion that     exposure to CS causes significant changes in host defense responses, which may be linked to     permanent changes in epithelial cells at the genomic level, it is not known whether new and     emerging tobacco products have similar or distinct effects.      Using live attenuated influenza virus (LAIV) inoculation in human volunteers, this study will     compare influenza-induced responses in non-smokers (NS), cigarette smokers (CS), e-cigarette     smokers (EC), hookah smokers (HS), and Little Cigar smokers (LCS) in vivo. This will be done     by analyzing nasal viral titers, antiviral defense responses, inflammatory mediator     production, and markers of immune responses for LAIV-induced responses between the different     groups of volunteers.   "
96769|NCT02019732|"     This is a database study to quantify the burden of multiple mild outcomes (i.e., those that     result in visits to a physician's office) attributable to influenza in the United States,     stratified by age group, geographic region and influenza subtype for selected influenza     seasons.   "
96770|NCT02019719|"     This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin     (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic     kidney disease (CKD). It is anticipated that the data generated will enable selection of the     starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This     study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a     follow-up visit approximately 4 weeks after completing treatment.   "
96771|NCT02019706|"     Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have     ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol     excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found     initially despite very detailed and extensive imaging, including studies such as computed     tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the standard     dose of indium-111 pentetreotide ([(111)In-DTPA-D-Phe]-pentetreotide). The sensitivity and     specificity of structurally based imaging studies depends on anatomic alterations and the     size of the tumor. In contrast, positron emission tomography (PET) and somatostatin ligand     (like octreotide) imaging detect pathologic tissue based on physiologic and biochemical     processes within the abnormal tissue. This protocol tests the ability of     [(18)F]-L-3,4-dihydroxyphenylalanine ((18)F-DOPA) PET, Octreoscan and another somatostatin     imaging analogue, (68)Ga-DOTATATE-PET, to localize the source of ectopic ACTH production. The     study also examines whether administration of the glucocorticoid antagonist mifepristone can     improve the sensitivity of the (68)Ga-DOTATATE PET/CT.   "
96772|NCT02019693|"     Background:        -  Papillary RCC is the second most common histologic subtype of kidney cancer, accounting          for approximately 10-15% of cases        -  Type 1 papillary RCC occurs in both sporadic and hereditary forms, which are          histologically identical. Non familial type 1 papillary RCC can present as both solitary          renal tumors and as bilateral, multifocal disease        -  There are no standard agents of proven efficacy for patients with advanced papillary      RCC.        -  Patients with disease localized to the kidney are managed surgically while patients with          advanced/unresectable disease are usually managed in the community with VEGF pathway          antagonists or mTOR inhibitors.        -  Activating mutations of MET were identified in the germline of affected HPRC patients,          who have a predilection for the development of bilateral, multifocal type 1 papillary          RCC. Somatic MET mutations have been found in a subset of patients with non-inherited,          sporadic papillary renal carcinoma        -  The investigational agent INC280 is a selective MET inhibitor lacking activity against          the VEGF pathway        -  This is a proof-of-concept study using INC280 in patients with papillary RCC to test the          idea that effectively blocking the HGF/MET pathway will lead to clinical activity in          patients with papillary renal cell cancer      Objectives:      Primary Objective:      -To determine the overall response rate (RECIST 1.1) in patients with papillary renal cell     carcinoma treated with single agent INC280      Eligibility:        -  Diagnosis of hereditary papillary renal carcinoma (HPRC) or sporadic papillary renal          cell carcinoma (RCC)             -  Patients with bilateral multifocal disease can have tumors localized to the kidney               or have metastatic disease             -  Patients with sporadic papillary RCC (but without multifocal disease) should have               advanced disease that is considered unresectable        -  ECOG 0-2        -  Measurable disease        -  Adequate organ function        -  No active brain metastases        -  Prior therapy             -  No more than 3 prior lines of systemic therapy             -  Prior therapy with a MET inhibitor is allowed as long as the patient has not had               progressive disease while receiving the agent      Design:        -  This is a phase 2 single center non-randomized trial.        -  The study will be conducted using a Simon 2 stage minimax design. Initially 13 evaluable          subjects will be recruited. If there are no responses to therapy, the study will be          terminated. If there is at least 1 response an additional 7 evaluable subjects will be          accrued.        -  The two-stage minimax design is based on assuming an ineffective response rate of 5% and          a targeted effective response rate of 25%. We also assume that the probability of          accepting an ineffective treatment and the probability of rejecting an effective          treatment are each 10%.        -  Subjects will be dosed orally at a starting dose of 600 mg twice daily.        -  The overall response rate (complete response + partial response) will be determined.   "
96773|NCT02019680|"     Background:      - Heart disease is the leading cause of death in the United States. Eating fruits and     vegetables with chemicals called flavonoids may protect against heart disease and improve     blood flow to the heart. They are found in blackcurrant berries. Oils found in fish and     mussels called omega-3 fats have also been shown to protect the heart. Researchers want to     know if blackcurrant extract and omega-3 fats can improve blood flow, which may increase     blood to the heart. They also want to learn about the health of blood vessels and how the     heart works.      Objective:      - To learn if blackcurrant extract and omega-3 fats will improve blood flow and make the     heart beat stronger.      Eligibility:      - Healthy adults 55 to 75 years old.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Visit 1 will take 6 7 hours.        -  Participants will have physical exam and blood and urine tests.        -  A small device like a microphone will be placed on their arm to take pictures of blood          vessels. A blood pressure cuff will be tightened on their arm and more pictures will be          taken.        -  Blood pressure cuffs will be placed on their arms and legs. They will be tightened at          the same time and blood pressure will be measured.        -  Participants will answer questions about their eating and exercise.        -  Every 8 weeks, participants switch from taking blackcurrant and/or omega-3 tablets to a          placebo to no tablets. <TAB>        -  Every 8 weeks, they will have another shorter clinic visit that will repeat most of          visit 1.   "
96827|NCT02018783|"     The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for     immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One     hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups     according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate     and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate     nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to     the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline,     immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used     to assess the sensitivity level.   "
96774|NCT02019667|"     Objective:      To perform a clinical trial assessing the safety, tolerability and efficacy of the GABA(B)     receptor antagonist SGS-742 in patients with SSADH deficiency.      Study Population:      Twenty-two children and adults with SSADH deficiency.      Design:      Double-blind, cross-over, phase II clinical trial. SGS-742 is a GABA (B) receptor antagonist     that has shown to be safe and well-tolerated in clinical trials in adults with cognitive     impairment. In addition, preliminary data in the SSADH knockout mouse model suggest efficacy     in this specific syndrome. The primary outcome measure will be a change in the Auditory     Comprehension subtest of the Neuropsychological Assessment Battery Language Module score; the     secondary outcome measure will be a change in cortical excitation and inhibition measured by     transcranial magnetic stimulation (TMS). Additional evaluations will include neurological and     neuropsychological examinations, magnetic resonance spectroscopy and CSF collection to     measure GABA levels. The trial will have a baseline phase in which each patient will undergo     a neurological examination and a neuropsychological evaluation. During the subsequent     treatment phase, patients will be randomized to SGS-742, supplied by IRIX Pharmaceuticals,     and based on weight given a maximum tolerated dose not to exceed 600 mg t.i.d. orally, or     placebo, each for 6 months. Patients will then have repeat TMS, neurological and     neuropsychological evaluations, followed by cross-over to the alternate treatment arm, and     re-evaluation after 6 months.      Outcome Measures:      The primary outcome measures for drug efficacy will be performance on neuropsychological     testing and responses to parent questionnaire. The secondary outcome measure will be TMS     parameters of cortical excitation and inhibition. The outcome measures for safety will     include clinical examination and neuropsychological tests.   "
96775|NCT02019654|"     Objective: A traumatic brain injury (TBI) places individuals at high risk for developing     posttraumatic stress disorder (PTSD). TBIs account for the onset of PTSD in approximately     700,000 Americans each year. Depression and post-concussive syndrome (PCS) are also common     and often comorbid with PTSD. However, even in this group, there is a high-level of     inter-individual response to traumatic brain injuries, suggesting that a better understanding     of the mechanisms underlying this risk would be of great value in directing preventive     interventions. The reasons for this heterogeneity are undoubtedly multi-factorial, and     involve a complex interplay between genetic and environmental factors, that we may be able to     understand through peripheral biomarkers and central examination of neuronal functioning. We     suggest that DNA methylation may be a putative biomarker of psychiatric risk, as it reflects     long-term changes in the function of the gene and may shape the recovery ability of the TBI     patient through changes in cell function. In addition, differential proteomic response,     including the function of the neuroendocrine system, likely relates to changes from     epigenetic modification in both neurons and immune cells, which may contribute to the risk     for the onset of PTSD as well as depression and PCS. We have previously shown that both PTSD     and depression are associated with endocrine alterations, leading us to question if this     biological change may underlie vulnerability for the onset of PTSD as well as depression and     PCS following a TBI. In support of the idea of shared vulnerability, patients with a TBI also     often display endocrine function alterations. In addition, sleep disturbance is common     following TBI and is a core symptom of PTSD depression and PCS, suggesting that sleep may     contribute to psychiatric and neurological recovery from a TBI. This line of research is     essential, as current treatments to prevent or treat psychiatric risk following TBI are often     ineffective, and even treatment of PCS is limited. This poor understanding results in our     limited ability to reduce the risk for compromises in the health and well-being of patients     who sustain a TBI.      Study population: Participants with a moderate or mild TBI (n=100) will be followed for a     period of one year.      Design: This is a natural history study that will recruit patients within 30 days of a     mild/moderate TBI, and will follow them over a one year period, with follow-up at 1, 3, 6 and     12 months following the TBI. Biological profiles including the concentration of inflammatory     proteins and neuropeptides, and DNA methylation will be examined. An optional structural and     functional magnetic resonance imaging (fMRI), and a hydrocortisone stimulation test will be     used to evaluate the role of neuronal and neuroendocrine functioning following TBI.      Outcome measures: The primary outcomes of interest are the biological changes that occur     following TBI which are associated with the onset of psychiatric disorders of PTSD, and     depression, as well as the onset of PCS. The secondary aim is to examine neuronal mechanisms     that underlie the risks for these disorders through the use of fMRI. Additional aims will     determine the role of psychological resilience traits in recovery and also how sleep relates     to recovery and psychiatric risk.   "
96776|NCT02019641|"     Interstitial lung disease (ILD) is the result of over 200 etiological pathways arising from     several different insults to the lung parenchyma: inhaled substances, drug side effects,     connective tissue disease, infection, and malignancy. The disease can also be of idiopathic     origin. If prolonged, the resulting inflammation causes permanent and progressive fibrotic     reorganization of the parenchyma and small airways, which reduces the distensibility of the     lung and impedes O2 and CO2 exchange.      This study is a randomized controlled trial to determine the safety and efficacy of aerobic     exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary     hypertension. In an uncontrolled study, we observed more efficient cardiorespiratory     function, increased physical work capacity, and improved health-related quality of life     following aerobic exercise in this study population. Serious adverse events resulting from     aerobic exercise training were not observed and our work to date has established plausibility     for the efficacy of aerobic exercise training and its safety for patients with ILD.   "
96777|NCT02019628|"     The present study investigated the effect of RBAC on natural killer cell activity (NKCA) and     the production of cytokines and growth factors over 4 weeks among healthy adults.   "
96778|NCT02019615|"     In this study researchers will apply transcranial direct current stimulation (tDCS) for 5     consecutive days in chronic patients in minimally conscious state (MCS).      2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each     stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised     (CRS-R). A final assessment will be done one week after the end of the sessions to assess the     long term effect of the tDCS.   "
96779|NCT02019602|"     The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from     pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating     the concentration of CZP in the plasma of infants at birth.   "
96780|NCT02019589|"     This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled,     parallel group, multiple-dose design.      The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period     (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and     Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be     performed at the following time points:      Screening Period:      • Screening Period (approximately 42 Days)      Open-Label Estrogen Priming Period (Run In Period):        -  Visit 1 Baseline (Cycle 1, Day 1)        -  Telephone Interview (Cycle 1, Day 28 [- 3 d to ±1d])      Blinded Treatment Period:        -  Visit 2 Randomization (Cycle 2, Day 12 [±2d])        -  Visit 3 Interim (Cycle 3, Day 12 [±2d])        -  Visit 4 End of treatment (Cycle 3, Day 24 [±1d])      Follow-Up Period:        -  Visit 5 Follow-Up (Approximately 10 days after the last treatment)        -  Telephone Interview (Approximately 2-4 weeks after completion of progestin course) (Only          applies to subjects receiving an approved progestin therapy for proliferative          endometrium, as determined by biopsy.)   "
96781|NCT02019576|"     Stereotactic radiotherapy (SRT) is a newer type of focused radiation therapy that precisely     and accurately delivers high dose radiation to a tumour, while sparing much of the nearby     normal organs. The use of stereotactic radiotherapy results in high rates of tumour     destruction with minimal side effects which are very well tolerated. Often stereotactic     radiotherapy has been used to try to cure patients who have an early stage cancer which has     not spread, but there is less experience with using it in patients with cancer which has     spread.      The purpose of this study is to measure how well stereotactic radiotherapy can destroy kidney     cancer tumours which are no longer being controlled by Sunitinib and to measure how much     longer such an approach will allow patients to stay on Sunitinib before needing to switch to     another medication. Stereotactic radiotherapy will be used to treat only the growing tumours     and then patients will continue with Sunitinib.   "
96782|NCT02019563|"     To compare radiographic and clinical outcomes and survival of mineral trioxide     aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital     primary maxillary incisors.   "
96783|NCT02019550|"     This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to     evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with     relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up     to 10 weeks (including screening and treatment periods). The treatment period will last 8     weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections     using the Rebiject II® device.   "
96784|NCT02019537|"     The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with     subacromial impingement disease   "
96785|NCT02019524|"     This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate     binding protein vaccines E39 and J65. The study target population are patients with breast or     ovarian cancer diagnosis who have been treated and are without evidence of disease.     Disease-free subjects after standard of care multi-modality therapy will be screened and HLA     typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted     to HLA-A2+ patients (approximately 50% of the U.S. population).   "
96983|NCT02016755|"     The purpose of the study is to confirm the feasibility of study procedures and the     tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)   "
96786|NCT02019511|"     It has been shown that a single high dose of steroid before surgery may reduce pain the first     48 hours after insertion of a new joint in the knee, a so called total knee arthroplasty     (TKA). Consequently, this has been introduced as standard treatment of most patients at     several Danish orthopedic departments. Although there are some concerns about the possibility     of increased risk of prosthesis infections, this has not been proved in previous studies.     However the studies are few, have limited number of patients and are not done using a     standardized perioperative set-up.      This study is made to monitor the safety of a single high dose steroid injection before TKA,     with regards to prosthesis infection within one year of surgery.      We hypothesize that there will be no increase in infections in patients receiving steroid     injection before TKA compared to a historical cohort of patents who did not receive a steroid     injection before their TKA.   "
96787|NCT02019498|"     The aim of the pragmatic randomized study is to evaluate whether additional relaxation     technique is more effective in the reduction of chronic low back pain compared to usual care     alone.   "
96788|NCT02019485|"     The purpose of this study is to evaluate bioequivalence (biological equivalence of two     formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg     tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg,     prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted     (without food) conditions.   "
96789|NCT02019472|"     The primary objective is to investigate the efficacy of sirukumab monotherapy compared with     adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are     intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate     or who are inadequate responders to methotrexate.   "
96790|NCT02019459|"     Smokers with schizophrenia (SWS) infrequently attempt and attain sustained smoking abstinence     and have a 25-year shorter lifespan due to smoking-related illness. This study will examine     whether reducing the nicotine content of cigarettes to non-addicting levels is a viable     method of reducing smoking in this population. Smokers will be randomized to one of two     experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine     content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use,     biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal     symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking     topography.   "
96791|NCT02019446|"     Fungal infections of the toe affect one in three people with diabetes. Current treatments for     fungal toe infections include oral medications, but these drugs often interact with other     common medications. We are studying a new treatment for fungal toe infections involving the     use of a laser device. We will compare to the standard treatment which is a type of     antifungal medication. This laser has been tested in small numbers of patients with minimal     side effects. There will be 60 participants selected for our study, of which 30 will receive     standard treatment and the rest will receive laser treatment.   "
96792|NCT02019433|"     Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment     Structan®   "
96794|NCT02019212|"     The purpose of this study is to evaluate the quality and prognostic ability of low dose     99mTc-tetrofosmin Myocardial Perfusion SPECT Imaging.   "
96795|NCT02019199|"     This study is a research initiative established to explore the use of magnetic resonance     imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation     therapy.   "
96796|NCT02019186|"     The endothelium is the lining of the blood vessels that helps prevent damage to the vessels.     The endothelium does not function as well as it should in adolescents with type 1 diabetes.     This causes future diabetes complications. Adolescents with diabetes also have abnormalities     of the cells that repair the endothelium. These abnormalities may be due to damage caused by     intermittent hyperglycemia. This studied is designed to study whether low dose, combined     Vitamin C and E supplementation improves endothelial function and repair in adolescents with     type 1 diabetes.   "
96797|NCT02019173|"     The purpose of this study is to determine        1. if it is practical to treat moderately to severely brain injured patients who have          problems with their balance and mobility in a group boot camp (3 days a week, 6          hours/day for 4 weeks) exercise class.        2. If they show improvements compared to 4 weeks of not receiving this treatment        3. If electronic daily monitoring of their center of foot pressure during a standardized          balance task will allow us to see small changes in ability.      A baseline assessment of all outcome measures will be performed. This will be repeated 4     weeks later. The intervention will be delivered (4 weeks) and a follow up assessment of all     outcome measures will be performed one week later. A follow up of the Primary outcome     measure, the PART-O participation questionnaire will be done 12 weeks later.      Participants will attend group therapy consisting of a variety of exercises designed     specifically to target balance and mobility deficits and based on the concept that through     Repetitive Functional Task Practice (RFTP), recovery of function can occur as the result of     neural adaptation. Exercises will be both individualized (delivered in a circuit) and group     activities. Supervision and guidance will be provided by a registered Physical Therapist and     a Rehabilitation Assistant. During the intervention, the amount and type of RFTP, any adverse     events, and any need for extra staff will be recorded on a daily basis. As well, a     standardized individualized task will be performed with center of foot pressure recording on     a daily basis.      Analysis: changes in outcome measures immediately after the non-intervention compared to the     after the intervention period will be statistically determined to estimate efficacy of this     treatment model. Descriptive measures of RFTP time/day, staffing levels/day and adverse     events will be used to support feasibility and safety of this model.   "
96841|NCT02018601|"     The main objectives of the trial are the efficacy and safety of intercostal nerve block in     the midaxillary line versus paravertebral block, both guided by ultrasound in patients     scheduled for not reconstructive breast surgery.   "
96842|NCT02018588|"     Our objective is to determine the requirement for the amino acid tryptophan in school age     children using the indicator amino acid technique.   "
96843|NCT02018575|"     Our objective is to determine the metabolic availability of Lysine in white maize using the     indicator amino acid oxidation (IAAO) technique in adult men.   "
96828|NCT02018770|"     The present study aims to evaluate the effect of phototherapy with the combination of     different sources of light on pain, activity of temporal and masseter muscles, bilateral and     joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and     double-blind clinical trial. Individuals participate with myogenic temporomandibular     disorder, being allocated into 4 groups randomly and stratified by the method of sealed     envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography,     and visual analog scale and algometry. The protocols will be used in a single session and     will be evaluated in four different moments. The variables that will be investigated are     pain, muscle activity and joint mobility. The analyses of the data will be performed by     adopting a significance level of 5%.   "
96798|NCT02019160|"     -  Aim: This randomised controlled trial will systematically compare the efficacy of a 25%          AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting          caries teeth among preschool children when applied at half-yearly intervals over a          30-month period.        -  Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement          will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical          trial. Approximately 2,400 kindergarten children will be screened and at least 826          children with caries will be recruited. This sample size is sufficient for an          appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of          α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into          2 groups to treat their caries over a 30-month period: Group A - biannual application of          a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of          a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted          at 6-month intervals to assess whether the caries are arrested. Information on          confounding factors such as oral hygiene habits will be collected through a parental          questionnaire.        -  Possible results and implications: As the first of its kind, this study would help to          determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting          childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride,          respectively, than 38% SDF, their use would be more favourable than SDF in young          children.   "
96799|NCT02019147|"     Despite recent advances in the care of mothers and newborn infants, many infants     (approximately 20 per 1000 live births) continue to need resuscitation at birth. A proportion     of these infants will have sustained significant injury through interruption of their blood     and oxygen supply prior to delivery (perinatal asphyxia). In 2-3 babies per 1000 this will     lead to brain swelling and the risk of long term brain injury called neonatal     hypoxic-ischaemic encephalopathy (HIE). HIE remains a cause of neonatal death and long term     disability. Early and accurate prediction of outcome would allow us to intervene during the     window of the first 6 hours following birth, prior to secondary reperfusion and secondary     brain injury. Estimating severity of injury can be difficult in newborn infants. Condition at     birth does not predict neonatal, or longer term outcome. Biomarkers which could be measured     at the time of birth and analysed at the bedside would offer these infants the best chance of     timely and effective intervention. Through the BIHIVE study we have identified a number of     predictive biomarkers in hypoxic-ischaemic encephalopathy. These markers are present in     umbilical cord blood and have been identified through proteomic and metabolomic analysis of a     stored biobank of samples from a recruited cohort of infants with perinatal asphyxia and     hypoxic-ischaemic encephalopathy. We now wish to validate these biomarkers in an additional     cohort, and will continue to explore new biomarkers in our stored biobank of umbilical cord     samples. In addition we wish to assess our ability to predict neurodevelopmental and     behavioural outcome in these infants. In this way we will determine the most robust     biochemical and clinical markers for the prediction of early and medium term outcome in HIE.     This study will establish the evidence base and validation of these biomarkers to the point     where they can be developed into a bedside diagnostic algorithm which can be used in the     labour ward to immediately identify those infants at risk of HIE in time to prevent secondary     damage.   "
96800|NCT02019134|"     The aim of the pragmatic randomized study is to evaluate whether additional relaxation     technique is more effective in the reduction of chronic neck pain compared to usual care     alone.   "
96801|NCT02019121|"     Investigators aim to retrospectively research patients undergoing renal transplants that     received dexmedetomidine perioperatively to see if dexmedetomidine use protects renal     function. Investigators hope to elucidate any association between renal transplant patients     and perioperative dexmedetomidine administration, these include (but are not limited to) UOP,     Cr/GFR, morbidity, mortality, in hospital complications and failure rate. Investigators will     research both living and cadaveric renal transplants.   "
96802|NCT02019108|"     Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian     adults. Excessive and unbalanced loads passing through the knee joint have been implicated in     the progression of OA. Typical conservative treatment of OA has focused on increasing daily     activity, without consideration for the underlying joint loading. This study aims to compare     a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during     walking - a measure shown to reduce joint loading and OA disease progression - while     increasing walking time/distance, with a standard walking program that aims to increase     walking time/distance. It is predicted that the walking program focusing on increasing     toe-out will provide greater reductions in self-reported knee pain and a greater reduction in     unfavorable knee joint loading.   "
96803|NCT02019095|"     In a recent experimental study, the investigators showed that the growth factor Activin A is     expressed in the lungs of rats with the acute respiratory distress syndrome (ARDS) at levels     that are comparable with those determined in the bronchoalveolar (BAL) lavage fluid from     patients with ARDS. In the same study, the administration of the Activin A inhibitor     Folistatin resulted in attenuation of the histological damage of the ARDS-afflicted rat lung.      The precise role of Activin A/Folistatin in acute respiratory failure associated with acute     lung inflammatory pathology has not been elucidated yet. Therefore, the purpose of the     present, observational study is to investigate the role of Activin A/Folistatin in     respiratory failure due to ARDS and/or ventilator-associated pneumonia (VAP), also in     relation with other biochemical markers, such as cytokines and surfactant-related proteins.   "
96804|NCT02019082|"     This study aimed to investigate the effect of low intensity cathodal direct current on the     release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic     foot ulceration.   "
96805|NCT02019069|"     This phase II clinical trial studies how well liposomal cytarabine-daunorubicin CPX-351     (CPX-351) works in treating patients with relapsed or refractory acute myeloid leukemia or     myelodysplastic syndrome. Drugs used in chemotherapy, such as liposomal     cytarabine-daunorubicin CPX-35, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing.   "
96806|NCT02019056|"     The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the     Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease     and Alcoholic Hepatitis.   "
96807|NCT02019043|"     This study aims to enhance syphilis testing among HIV-positive men who have sex with men     (MSM), so that more men will undergo testing, they will test more often, and more cases will     be treated early. The intervention will combine syphilis tests with the standard HIV blood     tests that are routinely done every 3-6 months for persons in care at hospital-based HIV     clinics in Toronto and Ottawa, Canada.   "
96808|NCT02019030|"     The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton     electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation     medication.   "
96809|NCT02019017|"     Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary     symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial     sweating. The headache is believed to be the most intense of all headaches and among many is     totally disabling and of great personal and social consequences. For a small group of     patients with episodic and most chronic form, drug therapy has little effect. For them,     surgery can be a solution.      Neuroradiology has found evidence of a possible original activation of cluster headache from     the portion of the brain called hypothalamus. Furthermore, an activation of the     parasympathetic nervous system through the sphenopalatine ganglion, which may also explain     some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of     Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve     signals being blocked. The duration of such a blockade is believed to be 3-9 months.      The purpose of the present study is to develop and evaluate a new surgical procedure with     injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the     symptoms of refractory cluster headache with a minimal invasive procedure.      The main objective of the project is to determine the safety of BTA injection in the area of     the sphenopalatine ganglion of refractory cluster headache and detect the adverse events.     Secondary objectives are to identify the changes of headache attacks by the method used.   "
96810|NCT02019004|"     The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A)     versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical     lines between the eyebrows) wrinkles.   "
96811|NCT02018991|"     The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce     allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM)     with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM     in DES with newer-generation polymers designed to improve biocompatibility are unknown.   "
96812|NCT02018978|"     This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce     population-level HIV incidence. The study design is a two-arm community randomized controlled     trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV     center which will provide free HIV testing and counseling, (b) Educational activities related     to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime     provision of a small amount of food or health products for sex partners of persons testing     positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A     post test support club for persons infected with HIV, (f) An income generation training     program for people testing positive for HIV, (g) Transportation assistance in visiting the     HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h)     Counseling and transportation support for those on medical treatment for HIV to assist them     in attending scheduled appointments, and receiving and taking their medications as     recommended by the clinic staff. The study will take place within two communities located in     Kisarawe district, Tanzania. The intervention will occur over an 18-month period with     outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals     in the intervention community will have a lower incidence of sexually transmitted infections     (STIs) than those in the control community.   "
96813|NCT02018965|"     There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels     and enable HIV-infected individuals to live longer. However, some participants taking     anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing AIDS     and non-AIDS-related complications.      ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3.     Niacin is effective in reducing cholesterol levels in the blood. This drug has been known for     a long-time to treat dyslipidemia and it is used to improve favourably all the lipoprotein     risk factors for artherosclerotic disease, particularly in HIV-infected patients. Recent     scientific research shows that regular consumption of niacin-rich foods may also provide     protection against Alzheimer's disease and age-related cognitive decline.      The purpose of this study is to find out:        1. If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could          reduce T cell immune activation and enhance CD4 recovery;        2. If ER niacin can improve your quality of life and your neurocognitive functions   "
96814|NCT02018952|"     The aim of this trial is to study the interest of ultrasonography among patients with septic     arthritis.      Currently, ultrasonography is useful for detecting small fluid effusions, for examining     otherwise inaccessible joints, such as the hip and for helping the joint aspiration.      Accurate assessment of disease activity and joint damage in septic arthritis is important for     monitoring treatment efficiency and for prediction of the outcome of the disease.      Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or     tomography for the detection of joint effusion and for differentiation between bone and soft     tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more     than 75%.      However, MRI is expensive and not rapidly accessible.      Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can     be used to assess the presence and extent of inflammation, destruction, and tissue response.      The objective is to describe, using ultrasonography, the abnormalities joint structure     influenced the septic arthritis evolution and prognosis.      The investigators hope, at the end of this study, to evaluate ultrasonography interest in     septic arthritis and to establish ultrasonography prognosis factors to predict treatment     efficiency and functional outcome.   "
96815|NCT02018939|"     The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF     (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System)     and intermittent hemodialysis.   "
96984|NCT02016742|"     The purpose of this study is to characterise the pharmacokinetics, safety and tolerability of     RDC5 given as a single dose to healthy volunteers at a number of different dose levels   "
96829|NCT02018757|"     The purpose of the study is to determine whether transarterial chemoembolization containing     arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular     carcinoma.   "
96929|NCT02017457|"     The present project is a multicenter, phase II trial which aims at evaluating if the     administration of azacytidine (Vidaza®) combined to donor lymphocyte infusion (DLI) could     improve the response rate to DLI in the population of patients with relapsed acute myeloid     leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic hematopoietic stem cell     transplantation.   "
96817|NCT02018913|"     Alzheimer's disease (AD) and vascular dementia (VaD) are the most common forms of dementia.     Yet, the cause of these diseases is still unknown. A potentially important initiating factor     is a disrupted blood-brain barrier. This can initiate cerebral microangiopathy, which has     frequently been associated with VaD. Nevertheless, also in most AD patients a substantial     increase of vascular damage has been observed. The present study investigates the correlation     between blood-brain-barrier breakdown and cognitive decline in AD and VaD. An innovative     dynamic contrast-enhanced MRI scan that has recently been developed and tested at our     institute, will be used to measure blood-brain barrier permeability.      Objective: We will investigate the relationship between this permeability measure and (i)     cognitive performance and (ii) the status of MRI visible cerebrovascular pathology (i.e.     white matter hyperintensities, lacunar infarctions, microbleeds) in the most common forms of     dementia.   "
96818|NCT02018900|"     In the present pilot study, the investigators will study the effects of a novel synbiotic,     which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain     fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the     gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that     the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and     modulate the immune system in humans.   "
96819|NCT02018887|"     The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it     causes any side effects. The study will also measure how much of the study drug gets into the     blood stream and how long it takes the body to get rid of the study drug. This is the first     time that this study drug is being given to participants. This study is for research purposes     only and is not intended to treat any medical condition.   "
96820|NCT02018874|"     In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a     high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown     synergistic activity in combination with targeted agents or chemotherapy including     gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different     tumor types with molecular alterations. This may validate the anti-tumor activity of the     LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.   "
96821|NCT02018861|"     Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to     find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor,     INCB050465, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1     inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. INCB050465     inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.   "
96822|NCT02018848|"     The goal of this study is to investigate an attention training program for participants with     Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task     with picture stimuli related to washing and checking paired with neutral pictures.      Participants are randomly assigned to an experimental and a placebo-control group. After a     minimum of 4 weeks of attention training we expect to find differences between participants     of the experimental and the control group in terms of attention bias, OCD symptoms, anxiety     and depression.   "
96823|NCT02018835|"     Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the     stress of exercise may offer early diagnostic indicators in patients suffering from valvular     disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining     importance in providing prognosis among those patients. However, decreased signal to noise     ratio in the images and increased motion-related artifacts during exercise stress     echocardiography have been reported, with a lack of reproducibility of results and a the     limitation of its availability only in reference centers. In our laboratory, we are able to     perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end     of the patient table, previously described in healthy volunteers.      The first aim of our study is to demonstrate the safety and the feasibility of our MRI     protocol in selected patients with asymptomatic severe organic mitral regurgitation, to     assess left ventricular volumes and function, and regurgitant volume in comparison to     exercise cardiac echography.      Besides, few recent studies sustain the relevance of novel markers of central aortic function     (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore     vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the     premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic     stiffness would be useful for risk assessment and preventive follow-up strategies in young     asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and     non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore,     this technique should be able to evaluate the effect of drugs on aortic stiffness change in     trials, before and after drug therapy, more relevant than the classic change in aortic     diameter measurement.      The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate     local and regional heterogeneity in aortic functional parameters (distensibility, compliance     and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by     MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and     to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave     velocity estimation by applanation tonometry.   "
96824|NCT02018822|"     This double blind randomized controlled prospective clinical trial will compare the clinical     success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply Caulk)     and an experimental urethane dimethacrylate resin based composite resin (Dentsply Caulk) for     wear resistance, staining and marginal seal using modified Ryge criteria to evaluate the     posterior restorations for 24 months in duration   "
96825|NCT02018809|"     To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence     Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by     an electronic pill bottle.      Hypothesis: Subjects with a MAP receiving daily adherence feedback will have the highest     statin adherence of any arm, as measured by pill bottle data.   "
96826|NCT02018796|"     The study will be conducted in 4 sites and will examine how a simplified outpatient medical     abortion procedure using mifepristone and misoprostol, with the option to take mifepristone     at a place of woman's choosing, works in Kazakhstan. The investigators intend to demonstrate     the efficacy of oral administration of 200 mg mifepristone and sublingual administration of     600 µg misoprostol with gestations through 70 days, as well as the acceptability of this     method. Research questions include:        1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by          600 µg sublingual misoprostol and used in gestations of up to 70 days?        2. Is medical abortion procedure consisting of two visits acceptable to women in          Kazakhstan?        3. Are the side effects associated with sublingual use of misoprostol acceptable to women?        4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of          their choosing?   "
96985|NCT02016729|"     Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute     myeloid leukemia.   "
96830|NCT02018744|"     This registry has been designed as a multicenter, single arm, open label, post-market     registry study with consecutive, eligible patient enrollment at each site. All subjects     undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects     will be followed up to discharge discharge, and as per institutional standard of care     thereafter through to 5 years (total follow-up commitment). This registry of the Nellix     System, which has received the market authorization of the European Union (Conformité     Européenne, CE-certification) in a real world patient population treated in a multicenter     setting will provide an assessment of the generalizability of the approach and System.      Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered     candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the     study.   "
96831|NCT02018731|"     The purpose of the study is to compare the effects of L-citrulline and metformin and their     combination therapy on muscle function and force in patients with Becker muscular dystrophy     (BMD).   "
96832|NCT02018718|"     The aim of this study is to demonstrate and quantify the micro architecture and micro     vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and     arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow     parameters will be registered before and after the long-distance run on the lower leg. Axial     T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory     markers will be collected in blood and urine samples and compare with both MRI and     Near-infrared spectroscopy (NIRS).   "
96833|NCT02018705|"     For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an     endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM).     Studies show promising short and mid term results for POEM. At present, POEM is considered a     promising new technique with the potential to become a standard achalasia treatment. For this     to happen, long-term comparative data with LHM is required. Therefore,the intention for this     study is to investigate the short and long-term efficacy of POEM for the treatment of     achalasia as it was performed in international centers and compare outcomes with database     assessment of LHM.   "
96834|NCT02018692|"     The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is     effective in the treatment of retinitis pigmentosa in adolescent patients.   "
96835|NCT02018679|"     Topical photodynamic therapy with methyl-aminolaevulinate (MAL-PDT) has been introduced as an     alternatively attractive procedure for BCC. Er:YAG ablative fractional laser (AFL) treatment     removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no     studies have directly compared the efficacy of Er:YAG AFL-PDT and MAL-PDT in treating nodular     BCC in Asians.   "
96836|NCT02018666|"     This is a multicenter, prospective, randomized, open-label study which compared two     ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter     is considered as the reference ventilatory mode) in patients admitted to the ICU for acute     respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize     patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous     ventilation.   "
96837|NCT02018653|"     The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can     help to stop your diarrhea. Researchers also want to know if this drug can help decrease the     duration of your diarrhea.      In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like     the study drug but it is not designed to treat any disease or illness. It is designed in this     study to be compared with the study drug to learn if the study drug has any real effect.   "
96838|NCT02018640|"     Use of tobacco is very high among Alaska Native pregnant women. The investigators are     conducting a three phase study. The first study is nearly completed and involved measuring     biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a     qualitative study to translate the biomarker findings to an intervention.   "
96839|NCT02018627|"     This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris     Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs.     micro-doses of Glucagon for Injection (Eli Lilly).   "
96840|NCT02018614|"     Acute pain is responsible for unnecessary suffering. Among elderly patients, acute pain is     frequent and underestimated, especially when these patients have cognitive disorders. The     expression of pain is then modified and the conventional tools for evaluating pain cannot be     used. Thus the existence of pain must be detected on the basis of a behavioural assessment.      It is nonetheless necessary to have the assistance of standardised and validated tools. In     France, the Doloplus Group has proposed a scale called Doloplus, validated in January 1999,     and is now proposing a new scale for acute pain, Algoplus that has been validated in French     (4). Doloplus has been recently translated and validated in 5 languages and an identical     methodology will be used in this protocol.      Internationally, although several teams are working on the development of scales that can be     used for non-communicating elderly subjects, there is as yet no validated tool for acute pain     assessment.      Considering 1- the lack of tools at an international level and 2- the frequent request from     many practitioners worldwide, the Doloplus group has offered to validate the Algoplus® scale     in 5 foreign languages, English, German, Spanish, Italian, Portuguese. A rigorous methodology     with the help of a statistician will be used in this validation process.   "
96856|NCT02018406|"     The purpose of our study is to determine the safety and efficacy of the combination of     erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients with     neurological diseases. To be specific, our clinical study is expected that the combination     injection of EPO and G-CSF shows neurotrophic and neuroprotective effects by facilitating     endogenous repair process in patients with neurological diseases including stroke, cerebral     palsy, or atypical parkinsonism. Therefore, we will apply our original treatment technique in     patients with neurological diseases, which is expected to overcome current ethical and     technical limitations of less evidenced functional recovery, hematological changes, and side     effects. Eventually, We will establish a comprehensive clinical background about neurotrophic     and neuroprotective effects of this hematopoietic growth factors therapy.   "
96857|NCT02018393|"     This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe     haemophilia A and inhibitors.   "
96844|NCT02018562|"     Verbal communication is vital to critically ill mechanically ventilated patient's quality of     life (Hess, 2005). Patients who have a tracheostomy tube may be able to communicate using a     speaking valve, however, some patients may not be able to tolerate cuff deflation for use of     speaking valve. There are talking tracheostomy tubes that do not require cuff deflation to     facilitate speech in this population. Unfortunately, not all candidates are offered these     options due to lack of awareness. Recently, at our institution, there has been an increase in     the use of these tubes to facilitate speech. One of the talking tracheotomy tubes that has     proven to be effective is the Portex Blueline Ultra Suctionaid (BLUSA).      In 2010, we conducted a retrospective review of 4 cases and found that BLUSA tracheostomy     helped facilitate communication in this unique population (IRB #: NA_00041547). We would now     like to formally conduct a prospective pilot study to evaluate the feasibility of measuring     outcomes of patients with a BLUSA using a pretest-posttest research design.      Communication empowers patients and allows healthcare staff to obtain a more accurate     assessment of patients' condition and tailor care accordingly. Identifying the predictors of     speech intelligibility and the impact of BLUSA on quality of life will promote communication     between patients and healthcare providers.      Study Hypothesis: Determine the impact of a talking tracheostomy tube on quality of life in     patients requiring prolonged mechanical ventilation in the hospital.   "
96845|NCT02018549|"     Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile     through the NEXThaler device in adult COPD patients with varying degrees of airflow     limitation   "
96846|NCT02018536|"     The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic     (what the body does to a medication) of GSK2336805 alone and with the co-administration of     TMC435 in healthy Japanese participants.   "
96847|NCT02018523|"     The purpose of this study is to investigate the safety and efficacy of maintenance therapy     with daily low dose lenalidomide in patients with stage IIIB/IV non-small cell lung cancer     (NSCLC) after first line chemotherapy. Investigators expect this treatment approach will     delay disease progression by boosting the patient's anti-tumor immune response. Investigators     hypothesize that 10 mg/day of lenalidomide can be administered safely as maintenance therapy     and improve progression free survival time.   "
96848|NCT02018510|"     The proposed study is a first-in-man phase I study that aims to evaluate the safety,     tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and     its antiretroviral activity in HIV-infected subjects.   "
96849|NCT02018497|"     The essential arterial hypotension and allostasis registry is a prospective, observational     research that has the purpose of demonstrating that essential blood pressure (BP) disorders     and the associated comorbidities are a result of the inappropriate allostatic response to     daily life stress. This required a functioning brain orchestrating the evaluation of the     threat and choosing the response, this is a mind-mediated phenomenon. If the response is     excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify     the allostatic pattern, which in turn will play an important role in the development of the     comorbidities.      To do so, consecutive patients of any age and gender that visit a cardiologist's office in     Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP     and allostasis and follow them in time to see what kind of diseases develops the most     (including BP) in the follow up according to the categorization of the characteristic chosen     and after adjustment for confounder's variables. In addition, stress events with their date     are registered.      HYPOTHESIS      The causes of the diseases are multifactorial.      Physical, biochemical, psychological, social, and cultural dimensions of development     dynamically interact to shape the health development process.      A person´s health depends on their:        1. Biological and physiologic systems        2. External and internal environment (a) physical, b) internal behavioural and arousal          state as registered by the brain.        3. Their interaction.      The allostatic mechanisms to the internal and external stressors (allostatic load) involves a     network composed by:        1. Functional systems; mediated by:             1. The Autonomic Nervous System             2. The endocrine system             3. The immune system        2. Structural changes: whenever the internal and/or external stressors are long lasting          and/or strength enough, they may induce changes in:             1. Epigenetic, endophenotypes, polyphenism.             2. Plasticity        3. The interaction between a) and b).      The network response do not affect exclusively the BP, propitiating the development of     comorbidities, which may prompt strategies for prevention, recognition and ultimately,     treatment.      The allostatic model defines health as a state of responsiveness.      The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis)     and psychological (psychostasis) abilities. It is proposed that both components behave in     similar direction and magnitude.      Immune disorders may be associated with the development of cancer. High BP population has a     higher sympathetic and lower vagal tone, this has been associated with a decrease in the     immune´s system function.      Resources and energy depletion: Terms like weathering have been used to describe how     exposures to different allostatic loads gradually scrape away at the protective coating that     keeps people healthy. It is postulated that High BP individuals have more resources and     energy.   "
96850|NCT02018484|"     Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of     the knee especially when it affects only the medial femoro-tibial compartment. To place the     prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence     the position of the different elements of the prosthesis and the limb alignment. It is known     that good positioning of the prosthesis is the key of a good survival of the implants. To     guide the blade of the saw, cutting guides are used. The position of these guides gives the     final position of the cuts. At present, two main techniques are used to position the guides:     the conventional one, not very costly but not very accurate, and the navigated procedure,     which is more accurate but also more expensive and more invasive. Since few years, patient     specific cutting guides are used in total knee replacement with encouraging results and more     recently in uni compartmental knee replacement with no scientific proof of efficiency.      This study aims to validate the procedure of patient specific cutting guides.   "
96851|NCT02018471|"     Diagnostic tests have a deep emotional impact on oncology patients. Anxiety and worries can     lead people to avoid screening tests, with high risks for health. A single arm, pilot study     was organized to evaluate the feasibility and efficacy of psychological counselling for     cancer patients who demonstrated anxiety for diagnostic tests. The hypothesis was that taking     part in Psychoeducative Training could offer a new modality to reduce anxiety, before and     during tests, and also the possibility to reinforce coping strategies.   "
96852|NCT02018458|"     The primary objective of this study is to determine the safety and feasibility of combining     cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy.      The secondary objectives of this trial are to determine pathologic complete response rates;     disease-free survival; to assess immune biomarkers of immunity (antigen-specific CD8+ T cell     immunity and TH2 T cells) in breast cancer biopsy specimens and blood samples in patients     receiving DC vaccinations; and to assess the feasibility of immunizing LA TNBC and ER+/HER2-     BC patients with patient-specific tumor antigens.   "
96853|NCT02018445|"     The objective of this study is to prospectively evaluate the performance of Integra Accell     Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as     compared to local autograft.   "
96854|NCT02018432|"     Main adverse events of Roflumilast are weight loss, loss of appetite, insomnia, headache,     diarrhea, vomiting, and nausea. Although the majority of these adverse reactions were mild or     moderate. They occurred mainly at the beginning of therapy and mostly resolved with continued     treatment around for two weeks according to experiences of clinicians. These adverse events     occur more often in Roflumilast 500 μg than 250 μg, having negative impact on compliance of     patients at the early stage of treatments.      Thus, investigators aim to compare the drop-out rates between the usual dosage (Roflumilast     500 μg once daily) and the dose escalation (Roflumilast 250 μg once daily for 4 weeks and     then escalating dose of 500 μg once daily).   "
96855|NCT02018419|"     This phase I/II study is designed to compare different treatment schedules of a personalized     anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion     with intra-tumor immunotherapy. The cryoablation causes the tumor to release tumor-specific     antigens into the surrounding environment. The injection of bioengineered allogeneic immune     cells, AlloStim(TM), into the lesion is designed to modulate the immune response and educate     the immune system to kill other tumor cells.   "
96885|NCT02018029|"     Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in     patients with refractory symptomatic chronic heart failure with reduced ejection fraction     (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically     ameliorated. They are called the non responders. Patient selection seams to be one of the     key to improve the efficiency of CRT. This protocol try to assess positive predictive factors     to CRT by a multimodal approach.   "
96859|NCT02018367|"     The overall goal of the study is to determine whether imaging with the low-cost High     Resolution Microendoscope(HRME) will increase the efficiency and yield of the current     standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide     an in-vivo optical biopsy that will be comparable to gold standard histopathology and allow     the endoscopist to make a more informed decision about whether to obtain a biopsy or even     perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).   "
96860|NCT02018354|"     The purpose of this study is to compare outcomes (failure, function, strength, range of     motion and quality of life) between patients who receive the usual anterior cruciate ligament     (ACL) reconstructive surgery and patients who receive anterior cruciate ligament     reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the     outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young     individuals who return to pivoting contact sports following ACL reconstruction. This study is     designed to look at whether or not adding this extra tendon repair reduces the risk of graft     failure in this population.   "
96861|NCT02018341|"     A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be     carried out on 30 healthy adult volunteers. The remedy used for the proving will be     administered in a potency of 30C. The remedy being used is a common homeopathic remedy     commercially available in the US, but the exact remedy is not disclosed to participants.The     purpose of the proving is twofold: 1) to determine if there is a difference in symptoms     between those receiving an active versus placebo medicine, and 2) to see if there is a     difference in gene expression between those who receive the homeopathic remedy or placebo. It     is hypothesized that participants receiving the active medication will have more symptoms     characteristic of the remedy and have specific patterns of gene expression in whole blood     that are different from those in placebo recipients. Participants will record symptoms in a     diary for 3 days prior to administration of study medications, during 3 day of its     administration and for 3 days following completion of the study medication. Blood will be     drawn for gene expression studies on the day that the study medication is started and again     after taking the study medication for approximately 48 hours. An additional, optional blood     draw for possible future analysis of gene expression will be done at the end of the study     period.   "
96862|NCT02018328|"     Background and Aims        -  H.pylori is a common human pathogen by which almost 50% of the world population is          infected. According to the accepted guidelines, once H.pylori infection has been          diagnosed,first line therapy with three drugs should be given. The triple treatment          includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is          only 70-80%.        -  Curcumin has many beneficial merits and it was also been demonstrated to be efficient in          inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether          addition of Curcumin to the standard triple therapy will increase the eradication rate          of H.pylori infection.      Methods        -  150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology          department and will be positive for H.pylori according to urease test and then by          gastric biopsy, will be included. The patients will be randomized to two different          treatments, according to binomial distribution. 75 patients will be treated with the          standard triple therapy for 10 days and the other 75, will be treated for 10 days, with          triple therapy combined with Curcumin that will be given three times a day.        -  During the treatment the patients will complete an adverse effect's questionnaires. 6          weeks after the completion of the treatment the patients will undergo urea breath test          to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds          or proton-pump-inhibitor until the second urea-breath-test.        -  We will compare the eradication rate and the adverse effects between the two groups by          using SPSS   "
96863|NCT02018315|"     The purpose of this trial is to determine if an alternative energy source will impact brain     metabolism in a disorder characterized by glucose metabolism failure in the brain.      The central hypothesis tested in this investigation is whether circumventing impaired glucose     metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors     through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC)     through alternative metabolic pathways.   "
96864|NCT02018302|"     This protocol provides ongoing access to triheptanoin for patients who did complete an     initial pilot protocol, and provides the opportunity to collect long-term safety data from     patients treated with triheptanoin.   "
96865|NCT02018289|"     The abdominal closure with triclosan coated suture will reduce superficial surgical site     infection.   "
96925|NCT02017509|"     This is an observational study of tumor samples and MRI imaging in patients with colorectal,     melanoma, breast, renal cell, lung, bladder, head and neck, ovarian and thyroid cancers. A     tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see     if it is possible to predict patients' response to treatment.   "
96926|NCT02017496|"     The study explores the safety of breast conserving treatment (BCT)(defined as complete     removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.   "
96877|NCT02018133|"     The purpose of this study is to identify genes that are responsive to paricalcitol (active     vitamin D) therapy. Scientists have found that over 30 different types of cells in the body     respond to vitamin D therapy, including blood vessels. Low levels of vitamin D may reduce the     amount of calcium in the blood, increase the amount of parathyroid hormone (PTH) and cause     the parathyroid gland (small gland located in the neck) to get bigger which is called     secondary hyperparathyroidism (SHPT). Also, low levels of vitamin D may worsen the heart     disease seen in dialysis patients. Paricalcitol, a man-made active vitamin D, is a     replacement for vitamin D for preventing and treating SHPT. Studies that followed patients on     dialysis have found: (1) differences in death rates between those who received active vitamin     D compared with no activated vitamin D, and (2) a survival benefit in chronic kidney disease     (CKD) patients receiving paricalcitol, over calcitriol (natural active vitamin D).     Researchers have considered that giving paricalcitol to people with (CKD) may also prevent or     slow the progression of heart disease.      Currently, physicians can only tell how well the vitamin D is working by measuring PTH     concentrations. This study aims to identify markers in the blood that can be used to     determine the efficacy of Vitamin D therapy.   "
96866|NCT02018276|"     Studies have attempted to control pain and increase patients' recovery satisfaction following     many kinds of operations by using as small an opioid analgesic dose as possible and adding a     nonopioid analgesic to reduce the side effects of narcotic analgesics. Among nonopioid     analgesics, lidocaine and magnesium are drawing attention, having been shown to be helpful in     controlling postoperative pain by lowering pain hypersensitivity to surgical stimuli.     Lidocaine acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor. An     intraoperative intravenous injection of lidocaine has been reported to improve postoperative     pain control by reducing postoperative pain and opioid consumption. Another report showed     that an intraoperative intravenous injection of lidocaine improved the quality of     postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy     patient. In addition, a review article on the effect of intraoperative intravenous injection     of magnesium found it to be an effective analgesic that may be added to conventional     opioid-based therapy because it generally reduces opioid consumption, decreases pain     assessment for 24 hours after surgery, and lacks severe side effects in relation to magnesium     administration. However, there has been insufficient research comparing the intraoperative     intravenous injection of lidocaine or magnesium in terms of which is more helpful for general     functional recovery and decreased postoperative pain. Recently, the scope of research on     anesthesia has come to embrace postanesthetic recovery; to help patients return to daily     life, the research trend is now shifting from the improvement or resolution of a specific     symptom to the measurement of general recovery. Postoperative recovery is a complicated     process related to such catamnestic factors as physiological end-points, the incidence of     adverse events, and changes in psychological status. A widely used method to measure     postoperative recovery is the Quality of Recovery 40 (QoR-40) survey. The QoR-40 includes a     total of 40 questions that may be divided into five sub-categories: emotional state, physical     comfort, psychological support, physical independence, and pain. The respondent answers each     question on a 5-point scale, with one being worst and five being best. The QoR-40 takes 6.3     minutes on average to complete and is known to have good test-retest reliability, internal     consistency, and split-half reliability. With respect to anesthetic recovery, the QoR-40 has     been used in various studies to investigate how the surgery type, anesthesia method,     administration of an additional drug, and gender affect anesthesia and surgery. The validity     of the QoR-40 for research purposes has already been established.      Therefore, in this study, we investigated the intraoperative intravenous injection of     lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in     the functional recovery of thyroidectomy patients after general anesthesia.   "
96867|NCT02018263|"     This study looks to explore the feasibility, sensitivity, validity, and specificity of a     Remote Wireless Sensor Network (RWSN) approach to the detection of cocaine use/intoxication     in the inpatient human laboratory, as well as in the outpatient setting (real world).     Lastly, we look to design an algorithm for reliably detecting cocaine use in real-world     settings and inference techniques for understanding the relationship between cocaine use and     user contexts.   "
96868|NCT02018250|"     This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when     delivered intramuscularly (i.m.) to the anterior thigh.   "
96869|NCT02018237|"     The purpose of this research study is to learn more about how high fructose corn syrup, a     sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without     nonalcoholic fatty liver disease. Eligible participants will be studied before and after     eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn     syrup) for four weeks.   "
96870|NCT02018224|"     The intention is to compare 60 patients with Achilles tendon rupture, who where randomized in     1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop     technique either without augmentation or with one central down-turned gastrocnemius fascia     flap (Silfverskjöld). Postoperative care was identical for both groups; A brace allowed free     active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to     neutral for the first three weeks. Weight bearing was limited for six weeks. To compare these     treatments, we use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and     MRI. Mean follow-up time is 14 years.      Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide better     result than would end-to-end suture repair with use of the Krackow locking loop surgical     technique in long-term follow up.   "
96871|NCT02018211|"     Numerous techniques are reported to enhance recovery following intense exercise, however     there is equivocal support for such claims. A novel technique of neuromuscular electrical     stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which     could enhance recovery following exercise. The present study examined the effects of NMES,     compared to graduated compression socks on muscle soreness, strength, and markers of muscle     damage and inflammation following intense intermittent exercise.   "
96872|NCT02018198|"     The purpose of this study is to investigate FebriDx, a point-of-care, non-invasive, rapid     diagnostic test, at identifying an immune response to viral and bacterial infection related     to an acute community acquired febrile upper respiratory infection, as compared to expert     clinical reviewers' evaluation in conjunction with the results of clinical standardized     microbiologic and laboratory testing.   "
96873|NCT02018185|"     In a preliminary pilot study, the investigators tested the efficacy of rTMS over the medial     prefrontal cortex in symptom profiles of obsessive compulsive disorder (OCD) patients. This     study revealed considerable benefit in using rTMS for the treatment of OCD.      In the current proposal, in a randomized clinical trial, the investigators aim to further     evaluate the efficacy of rTMS in OCD in a larger sample size and for a longer period. Studies     into the efficacy of rTMS in other psychiatric disorders such as depression have consistently     shown that extension of the treatment to four weeks significantly increased the effect size.     In the pilot study, the investigators applied rTMS for only two weeks. Although all patients     consistently showed improvement in their symptoms, none of them showed complete remission of     their OCD. Here, the investigators hypothesize that longer duration of rTMS treatment will     have greater benefit in OCD symptom reduction.   "
96874|NCT02018172|"     The study is performed to collect long-term data on the treatment adherence and patient's     acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in     patients with a growth hormone deficiency or Turner's syndrome.   "
96875|NCT02018159|"     This post-marketing, multi-center prospective study will be conducted in a open-label,     non-interventional setting, for women seeking fertility treatment and will describe     morphokinetic de-selection parameters in human embryos.   "
96876|NCT02018146|"     Failed mask ventilation poses an increased risk of de-oxygenation to the patient undergoing     general anesthesia. Nasopharyngeal ventilation may be a valid alternative for mask     ventilation allowing for better oxygenation during the induction phase of general anesthesia.     Oxygenation may be maintained better in case of difficult mask ventilation. This study     evaluates this alternative method in comparison with the standard method of mask ventilation.      General Design This is a randomized, controlled, cross over study. Patients will be     randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation or     vice versa.      Primary Study Endpoints We will test the hypothesis that ventilation via a nasally placed ETT     is superior in its efficacy (as measured by tidal volume) to routine facemask ventilation in     patients undergoing general anesthesia and endotracheal intubation for their surgery.   "
96879|NCT02018107|"     In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET     perfusion scans are more useful in helping radiologists determine whether liver tumors were     successfully destroyed by the heating or freezing procedures (ablations) than other scans     currently available to radiologists, such as CT scans and MRI scans.      The currently available scan (usually a CT scan with contrast dye) is not always effective in     showing how completely the tumor has been destroyed. The ammonia PET scan is a different way     of looking at how much tumor has been destroyed. This study will compare the standard scan     (CT scan) with the ammonia PET scan.   "
96880|NCT02018094|"     -  Lower limb amputations are performed usually as a last resort in patients with acute and          chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes or,          infection.        -  In the period 2003-2008 there were approximately 5,000 amputations per year in the UK.        -  The Centre for Disease Control defines a Surgical Site Infection (SSI) as an infection          within 30 days of an operation or up to one year if an implant is left in place and the          infection is related to an operative procedure.        -  Figures from the Surgical Site Infection Surveillance reported that the highest rate of          surgical site infection was reported in association with lower limb amputation at 13.1%.        -  There is a clear under-representation and the infection rate within our institution is          approximately 25% which reflects the infection rate reported in a recent trial by Sadat          et al (22.5%)        -  Prevention of surgical site infections is of paramount importance to patients,          healthcare providers and policy-makers, as they impact on morbidity and mortality and          have significant time and cost implications.        -  Currently there is NO CONSENSUS as to what the best practice is towards antibiotic          administration in such patients. From a questionnaire-based audit we performed including          vascular departments across the entire country, practice varies in both course duration          (single dose → 5 days antibiotic course) as well as choice of antibiotics.        -  The guideline at our institution suggests the 5-day course of antibiotic prophylaxis.          The course duration varies depending on the clinical picture as well as microbiology          results and recommendations.        -  There are no randomised control trials that have investigated this aspect of patient          care. We have set up one such trial and through it, we are looking to establish a          standard practice which will hopefully be as beneficial as possible to the patient but          also cost-effective for NHS.   "
96881|NCT02018081|"     The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients     suffering from pneumonia with taking into account physio-pathological parameters. 2. to     verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory     Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory     Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this     study.   "
96882|NCT02018068|"     Perineural injection of local anesthesic is currently the reference method for the treatment     of post operative pain in a patient undergoing major orthopedic surgery. Postoperative pain     is a dynamic phenomena in every patient. It is classified as intense during the first     postoperative hours after surgery, and decreases in a non-linear manner over the days     following the procedure. PCA (patient control analgesia) infusion of local anesthesic allows     an adaptation of the local analgesia doses to the evaluated pain scores, as well as permit a     decrease in adverse events related to the continuous infusion technique (motor or sensory     blockade, paresthesia, etc.). The physician can also modify the pump settings according to     the postoperative rehabilitation plan.The use of new communication techniques such as     telemedecine may be of interest in reducing treatment onset time and optimizing pain     management. The remote control consists to change the settings of the pump after if the     anesthesiologist was informed in real time (via a smartphone or a tablet) on patient pain     level, sensory and motor blockades. The physician goes to a dedicated website (Micrel     CareTM). and makes the necessary changes by remote control via a GPRS (General Packet Radio     Service) connexion. The aim of this prospective, comparative, multicentric trial is to     compare the effectiveness of patient management through two communication modalities: remote     control versus bedside care.   "
96883|NCT02018055|"     The purpose of this study is to evaluate the efficacy and safety of clopidogrel in stabilized     patients with acute myocardial infarction (AMI) who performed percutaneous coronary     intervention (PCI) with drug-eluting stents (DES) compared with ticagrelor.      In this study, 3,288 patients with AMI who underwent PCI with DES and took dual antiplatelet     therapy as aspirin and ticagrelor during 1 month from index PCI will be randomized to aspirin     and ticagrelor versus aspirin and clopidogrel during 11 months.   "
96884|NCT02018042|"     Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune     disease. In this disease, the immune system mistakenly destroys the hair follicle, causing     hair to fall out. Despite many people having this disease, research into its cause and into     new, better ways to treat Alopecia Areata has lagged far behind other similar diseases of the     immune system. Currently, there are no Federal Drug Administration approved drugs for     Alopecia Areata.      Abatacept (made by Bristol-Myers Squibb) is a safe intervention known to effectively treat     rheumatoid arthritis, another autoimmune disease, by fighting inflammation. There are some     genetic and chemical similarities between those with active rheumatoid arthritis and Alopecia     Areata, suggesting that treatment with the same drug is likely to be effective. In mice     specially designed for testing drugs for the treatment of human alopecia, this medication     worked to prevent the disease Alopecia Areata from starting.      To test Abatacept, we are going to treat 15 patients with moderate to severe Alopecia Areata     for 6 months. Each person enrolling into this study will receive the active study drug. The     effectiveness of the medication will be measured by changes in hair re-growth as determined     by physical exam and photography, as well as by patient and physician scoring. Patients will     be followed for another 6 months off of the drug to see if the effects of treatment last and     if there is delayed response. We have recently changed the study to allow testing of     abatacept in a few patients with alopecia totalis and universalis.      Small scalp biopsies and peripheral blood will be taken at the beginning of the study before     treatment and then after 4,12 and 24 weeks. The chemical analysis of these skin samples and     blood will help us to understand how the disease happens, how the treatment works, and     perhaps even guide us to better treatments in the future.   "
96886|NCT02018016|"     Background      Appendicitis is a common condition which represents a significant resource burden for the     Scottish National Health Service (NHS). It is unknown whether there are significant     differences in Scottish appendicectomy (appendectomy) outcomes which may be explained by     hospital volume. In many studies, hospital procedural volume has been shown to be predictive     of surgical outcomes.      Aims      The aim of this study is to compare appendicectomy outcomes in Scotland as they vary by     hospital procedural volume.      Methods      This research study is a retrospective observational enquiry which will utilise     administrative data from the Information Services Division (ISD) of NHS National Services     Scotland. Patient episodes will be identified by a procedure codes for appendicectomy. A 10     year period will be studied, from January 2001 to December 2010.      Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission     rate, 30 day re-operation rate, length of stay and negative appendicectomy rate.   "
96887|NCT02018003|"     The purpose of this study is to assess the women's quality of life, who accepted     chemotherapy,radiotherapy, concurrent radiochemotherapy or who didn't accept therapy, after     operation.   "
96888|NCT02017990|"     This study will evaluate the association between n-3 polyunsaturated fatty acids and patient     and graft survival. The association between other fatty acids and mortality and graft loss     endpoints will also be evaluated.   "
96889|NCT02017977|"     Introduction      'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which     are known to carry a significant risk of mortality and morbidity. Previous work has shown     considerable inter-hospital variation in emergency laparotomy outcomes within the United     Kingdom. It is unknown whether there are significant differences in outcomes following     laparotomy which may be explained by geographic factors.      Aims      The aim of this study is to describe emergency laparotomy outcomes in Scotland as they vary     by the urban-rural nature of the patient's home location and travel time from hospital.      Methods      This research study is a retrospective observational enquiry which will utilise     administrative data from the Information Services Division (ISD) of NHS National Services     Scotland. Patient episodes will be identified by a set of procedure codes for emergency     laparotomy, and the urban-rural classification of patients will be derived from postcode     data. Travel time from hospital will also be derived from postcode data. The investigators     will study a 10 year period from January 2001 to December 2010.      The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary     outcome measures will be 30 day readmission rate, 30 day re-operation rate and post-operative     length of stay.   "
96890|NCT02017964|"     This phase II trial studies how well combination chemotherapy works in treating younger     patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in     chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.   "
96891|NCT02017951|"     Introduction      Appendicitis is a common condition which represents a significant resource burden for the     Scottish National Health Service (NHS). It is unknown whether there are significant     differences in outcomes following appendicectomy which may be explained by geographic     factors.      Aims      The aim of this study is to describe appendicectomy outcomes in Scotland as they vary by the     urban-rural nature of the patient's home location and travel time from hospital.      Methods      This research study is a retrospective observational enquiry which will utilise     administrative data from the Information Services Division (ISD) of NHS National Services     Scotland. Patient episodes will be identified by a procedure code for appendicectomy, and the     urban-rural classification of patients will be derived from postcode data. Travel time from     hospital will also be estimated through postcode data. The investigators will study a 10 year     period from January 2001 to December 2010.      Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission     rate, 30 day re-operation rate, length of stay and negative appendicectomy rates.   "
96892|NCT02017938|"     Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past     researches indicated that more than half of the individuals with PD demonstrated fatigue     symptom. The severity of fatigue was also correlated to the quality of life in individuals     with PD. Finding the contributions of the central and the peripheral factors to fatigue,     building reliable fatigue indexes, and developing an effective training program for     individuals with PD are very important.      The purpose of this project is to develop non-invasive method to monitor central and     peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training     paradigm, and to evaluate the long term training effect in individuals with PD.   "
96893|NCT02017925|"     This randomized clinical trial studies pulmonary rehabilitation in improving lung function in     patients with locally advanced non-small cell lung cancer undergoing chemoradiation.     Individualized exercise rehabilitation programs may reduce breathing problems and improve     quality of life in patients with non-small cell lung cancer. It is not yet known whether     pulmonary rehabilitation is more effective when started during or after cancer treatment.   "
96894|NCT02017912|"     This is a multi-center, randomized, double blind, placebo controlled study to evaluate the     safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting     Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS .      MSC-NTF cells are a novel cell-therapeutic approach which is expected to effectively deliver     Neurotrophic factors, which are potent survival factors for neurons, directly to the site of     damage.   "
96927|NCT02017483|"     Lots of studies suggest that children with ADHD have deficits in facial emotion recognition,     especially for the negative emotion. But there were arguments for this deficit is a secondary     problem due to the general attention impairment in ADHD, or a specific social cognitive     processing to ADHD. The objectives of this study are to investigate that association between     the deficits in facial emotion recognition and the emotional attention processing in ADHD. In     this study, the investigators use the emotion attentional bias and emotional go / no go     paradigm to answer this question.   "
96986|NCT02016716|"     The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone     mineral density (BMD) in postmenopausal women with osteoporosis.   "
96987|NCT02016703|"     Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a     clear beverage, compared with placebo (saccharose) in 4-6 year old children.   "
96895|NCT02017899|"     This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of     5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB     vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at     enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of     placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same     concentration as study vaccine formulations. A total of 50 eligible subjects will be assigned     to one of five sequential cohorts of 10 subjects each.      Within each cohort, in an observer-blind fashion, subjects will be randomized to receive     three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen     concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive a     summary of all safety data obtained during one week follow-up post-first vaccination with the     lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board will     make a recommendation, as to whether the next cohort should be vaccinated with higher antigen     concentration or not.      Expected duration of the study for an individual subject is 9 months. Each subject will be     followed-up for 6 months after the 3rd vaccination.   "
96896|NCT02017886|"     To evaluate the effect of daily ingestion of the probiotic Lactobacillus reuteri on the     levels of secretory IgA and the cytokines Il1-beta, IL-6, IL-8 and IL-10 in saliva of healthy     young adults.   "
96897|NCT02017873|"     The main objective of this study is to evaluate the effectiveness and longevity of color and     Tooth sensitivity of patients undergoing home whitening peroxide 10% carbamide ( Whiteness     Perfect , FGM , Joinville , Santa Catarina , Brazil) , and the relationship with the     cigarette use for tooth whitening. They will be selected 120 patients with incisors darker     than A2, higher plants will be divided into 2 groups per center (n = 30 ) , GE - Group     Experimental ( smoking) and GC - Group Control ( non-smoking) . For the two groups will be     used Carbamide peroxide 10% for 3 hours daily for a period of 3 weeks. Color will evaluated     through the Vita Classical scale and Vita Easyshade Spectrophotometer in the periods: Home ,     for tooth whitening (1st , 2nd and 3rd week) and post- whitening ( 1 week and 1 month , 2 and     3 months). Patients recorded the perceived sensitivity through Numerical Analogue Scale (NRS     ) with values from 0 to 4, where 0 = no sensation, 1 = mild, 2 = moderate, 3 = severe and 4 =     significant , also in the Visual Analogue Scale (VAS ), with values from 0 to 10 where 0 = 10     = severe tenderness and sensitivity. for color analysis will be made two-way ANOVA (group vs.     treatment time ), being Over time the repeated measure ( α = 0.05). Test will be held on     Tukey to contrast the average ( α = 0.05). The sensitivity will be evaluated by the Fisher     exact test . It is expected that there is no difference on the effectiveness of home     whitening and tooth sensitivity between smokers and nonsmokers.   "
96898|NCT02017860|"     The purpose of this study is to collect and assess long-term safety of everolimus in patients     who are currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD&MA     study that has reached its study objectives, are not progressing on the current study     treatment as defined by the parent protocol and are unable to access everolimus treatment     outside of a clinical study. Parent studies eligible to participate in the roll-over study     will be decided by Novartis. Investigator initiated trials (IITs) will not be included. The     primary objective of the parent study must have been reached and the parent study must be in     the process of being completed and reported.   "
96899|NCT02017847|"     Aim of this study is to identify intensity cut off points for physical activity in a     population over the age of 70.   "
96900|NCT02017834|"     The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also     indicate it may result in faster surgery. A recently published randomized study from our     group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer     any reduction in OR time. The present study investigates the utility of the harmonic scalpel     in resections involving removal of oral cavity tissues as well as the neck. Oral cavity     resections are especially prone to blood loss and we believe the harmonic scalpel will confer     benefits in this type of surgery, potentially reducing the need for blood transfusion.   "
96901|NCT02017821|"     Physical health does not have a high priority in today's treatment of patients with substance     use disorder (SUD) patients have a poor physical health not only due to injuries related to     the substance abuse, but also because of the lifestyle that addiction causes. There are today     few studies that provide information about SUD patients' physical health. One of the     project's aims is to document the physical health of SUD patients in treatment, using     objective measures. After completion of various physical tests, an 8 week period of high     intensity aerobic training intervention will follow. It will be investigated if the SUD     patients are able to engage and participate throughout the whole training intervention, to     what degree the participants improve their physical health and the effect of physical health     improvement on substance abuse treatment.   "
96902|NCT02017808|"     This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the     evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated     with GA and in healthy controls.   "
96903|NCT02017795|"     Objectives:      The disease being studied is asthma. The main objective of this study is to assess the     feasibility of the recruitment goals and also the logistical issues related to use of     tele-health technology in developing electronic asthma action plan (eAAP) and communicate     with asthma patients in a time period of 24 months. The goals are: 1) enable asthma patients     to self-manage their asthma symptoms. The secondary, 2) help care providers to intervene     appropriately based on the patient's health status. The secondary objective is to explore the     cost-benefit and cost-effectiveness of the proposed technology. Our research group proposes     to complete a feasibility study, with an interim analysis for a formal power calculation and     then acquire ethics to report these results and study design with anticipated publication     prior to proceeding with a full randomized controlled trial to assess the efficacy of this     intervention. The outcome measure will be assessed and data will be presented in a 24-month     time frame.      Aims and goals:      The main aim of our proposed study is to assist asthma patients to practice asthma     self-management at home that will eventually enable them to control their asthma, and     specifically, prevent asthma exacerbation. Therefore, the ultimate goal of our proposed study     is to improve patient health outcome via enhancing patient-physician interaction and using a     more practical asthma action plan model (eAAP) that could be followed easily by the patient     and their doctor.      Our hypothesis is that asthma patients who have access to the electronic online action plan     complimented by weekly text messages to reinforce adherence will have a reduced rate of     asthma exacerbation. We further hypothesize that these subjects will have an improvement in     secondary measures including quality of life, better asthma control and patient satisfaction.     We also anticipate that such an approach in asthma management will be cost-effective as     outlined below.   "
97768|NCT02006472|"     This is a multicenter, multinational, randomized, parallel-group, double-blind,     placebo-controlled, does range finding study to compare the efficacy and safety of different     doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's     Disease (HD).   "
96904|NCT02017782|"     The aim of the study is to provide information which may help to improve the quality of the     life of persons exposed to indoor environments in Danish dwellings.      The experiment will document if dust and ozone contribute to deterioration of indoor air     quality and to the occurrence of symptoms and health effects.      The study is aimed at testing the hypothesis that the presence of ozone potentiate the health     and comfort effects of dust exposure in the indoor environment.      Testing this hypothesis will be based on the following questions:      Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause     unwanted health effects either by themselves or by interaction?      If so, does the presence of ozone potentiate the expected irritative effects of dust?      The challenge of these hypotheses will be made as a controlled experiment on humans in a     climate chamber under controlled exposure conditions.      This controlled human experiment should be able to substantiate the findings from the     intervention studies.      Furthermore, they ideally reflect something relevant to the general public and therefore     should have maximum public appeal and application possibilities.   "
96905|NCT02017769|"     We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in     maintenance treatment with immunoglobulin   "
96906|NCT02017756|"     Stroke is the first and the fourth leading cause of death in the United States and China,     respectively. Disruption of cerebrovascular vulnerable atherosclerotic plaque is the major     etiology of ischemic stroke. Therefore, early detection and treatment of vulnerable plaques     occurring at the feeding arteries to brain (cerebral arteries) will be helpful for prevention     of stroke.      Atherosclerosis is a systemic disease that usually affects multiple vascular beds. Previous     studies have shown that these high risk lesions in different segments of cerebral arteries     (intracranial and extracranial arteries) might be racially specific. It is reported that, in     stroke patients, intracranial vulnerable plaques are prevalent in Asian populations whereas     atherosclerosis more frequently involves extracranial carotid arteries in American subjects.     However, these findings are based on angiographic imaging approaches via measuring arterial     luminal stenosis. Because the atherosclerotic plaque often appears as outward expansion,     namely positive remodeling during progression, measuring luminal stenosis will underestimate     the disease severity. Hence, directly viewing the plaque in the vessel wall is strongly     suggested in order to objectively evaluate the cerebrovascular vulnerable plaque.      High resolution, black-blood magnetic resonance (MR) imaging has been widely used to     accurately characterize carotid vulnerable plaque in the last two decades. The aim of using     MR black-blood techniques is to suppress the blood signal (black) to enhance the signal     contrast between the vessel wall and blood in the arterial lumen. Excellent agreement has     been achieved between MR imaging and histology in identification of plaque components, such     as intraplaque hemorrhage and lipid core. For assessing carotid plaque, MR imaging is     superior to computed tomography and ultrasound imaging techniques due to its advantages     including noninvasive imaging, lack of ionizing radiation, excellent soft tissue resolution,     and multi-parametric image acquisition.      The Investigators hypothesize that there are specific characteristics in carotid vulnerable     plaques in Chinese patients with ischemic cerebrovascular events such as ischemic stroke and     transient ischemic attack (TIA). This study seeks to investigate the characteristics of     vulnerable plaque in carotid arteries using high resolution, black-blood MR imaging in     patients with recent TIA or ischemic stroke.      This is a cross-sectional, multicenter study. A total of 1000 patients will be recruited from     more than 10 different hospitals across China within 3 years. All patients will undergo MR     imaging for brain and carotid arteries within two weeks after symptom onset. The prevalence     of carotid vulnerable plaque and its correlations with brain ischemic lesions, traditional     risk factors, and regional distribution of China will be determined.   "
96907|NCT02017743|"     This study is a multicenter post authorization observational study. Cancer patients diagnosed     with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH     and the data will be recorded. Since this is an observational study there are no specific     treatment protocols, i.e., patients will be treated according to the best investigator's     criteria. Treatment protocol will be based on the routine treatment practice of the involved     investigator. Patients to enroll will be cancer patients diagnosed for VTE and who are able     to receive outpatient LMWH treatment. There will be no specific hypothesis to be tested.   "
96908|NCT02017730|"     The purpose of this study is to assess the safety and tolerability of a novel positron     emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement of     availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this     tracer to assess LPA1 receptor occupancy using [11C]BMT-136088 in the human lung following     oral administration of Bristol Myers Squibb (BMS)-986020.   "
96909|NCT02017717|"     The purpose of the study is to compare the efficacy and safety of nivolumab administered     alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain     cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab     administered alone or in combination with ipilimumab in patients with different lines of GBM     therapy.   "
96910|NCT02017704|"     This research is being done to compare the effectiveness of high dose endorectal     brachytherapy (END-HDR) and the standard treatment option of chemoradiation with Capecitabine     in the treatment of cancer of the lowest part of the bowel (rectum).   "
96911|NCT02017691|"     Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS     5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery     and respiratory support based on both measurements in preterm neonates during the first 15     minutes after birth.      Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who     require respiratory support will be eligible for the study.      Design: A prospective two-centre randomized controlled pilot feasibility study      Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine     non-invasive monitoring in the first minutes of resuscitation. In addition during the first     15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2     measurements will be used to guide supplemental oxygen support and respiratory support during     the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide     supplemental oxygen support and respiratory support during the first 15 minutes after birth.      Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2     measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm     neonates during the first 15 minutes after birth      Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or     >90th centile.   "
96912|NCT02017678|"     This is a single-arm open-label Phase 2 study in patients with peritoneal carcinomatosis of     ovarian origin that are not eligible for curative treatments. Patients will receive 5 weekly     IV infusions of JX-594 until radiographically determined progressive disease. Patients will     be allotted in a 1:1 ratio to undergo a laparoscopy and tumor biopsy 10 days after dose 1 or     10 days after Dose 5. Patients will be monitored on study until evidence of progression or     death or for 12 months post treatment.   "
97544|NCT02009397|"     The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both     ipilimumab and GM-CSF are intended to work with the body's own immune system to attack     melanoma cells in the body. This study will also demostrate how safe the combined drugs are     when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which     cannot be removed by surgery.   "
96913|NCT02017665|"     Worldwide, central nervous system infections such as inflammation of brain (encephalitis),     inflammation of meninges (meningitis) and sudden onset of weakness of muscles which maybe     infectious in origin result in significant illness and death and healthcare costs. Vast     majority of central nervous system infections remain without an identifiable cause. There is     also concern about new and emerging infections.      This study thus intends to fill in the gaps in knowledge with regards to central nervous     system infections in Singapore to give a thorough description of burden of causes of central     nervous system infections and detection of outbreaks of new pathogens. Patients suspected of     central nervous system infection will be recruited from 5 restructured Singapore hospitals     and their blood and other clinical specimens will be sent for testing. Patients will also be     followed up to assess long term outcomes and socio-economic costs of these infections. This     will help clinicians, policymakers and public health officials in estimating financial and     societal costs of CNs infections in Singapore.   "
96914|NCT02017652|"     CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue     oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements.     This monitor was recently FDA cleared for use on adult subjects.   "
96916|NCT02017626|"     The aim of this study is to investigate the safety and tolerability of Subcutaneous     Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish     parvalbumin (mCyp c 1) quantified in mass units:      To establish a safe dose of the candidate hypo-allergen in human subjects and To study the     pharmaco-dynamics of the hypo-allergen administered to human subjects.      The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish     allergic patients allocated into three different groups of eight.   "
96917|NCT02017613|"     The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K     delta/gamma inhibitor in patients with hematologic malignancies.   "
96918|NCT02017600|"     Investigator will assign 53 patients who had been histologically proven localized squamous     cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2     on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every     3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete     treatment per protocol and complete resection will be the primary variant to evaluate in our     study.   "
96919|NCT02017587|"     The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from     approximately 40 chronic HBV for biomedical research program led by VGTI Florida.   "
96920|NCT02017574|"     Stroke is one of the leading causes of chronic disability in Veterans. Stroke is associated     with significant loss of mobility, increased risk of falling, cardiovascular disease,     depression and neuro-cognitive impairment. These deficits negatively impact the independent     completion of the Activities of Daily Living (ADLs). Task-oriented training has emerged as     the dominant therapeutic intervention in the rehabilitation of chronic stroke victims. The     effectiveness of these interventions may be enhanced through facilitation of implicit     knowledge rather than explicit knowledge. Specifically, implicit learning increases retention     and improves transfer of the improved motor function outside of the lab environment.     Moreover, implicit motor control reduces the burden imposed on cognitive resources as the     skill is performed automatically (i.e. do not have to 'think' about it). The amount and type     of feedback individuals receive while learning a new task (or relearning in the case of     rehabilitation) has been shown to influence the type of learning (i.e. implicit or explicit).     Thus the purpose of the current study is to determine the effect of different types of     feedback during motor learning on the learning type and the resultant impact on functional     outcomes (i.e. motor performance, retention, and cognitive workload) in chronic stroke     patients.   "
96921|NCT02017561|"     Metabolic syndrome (MS) is a cluster of risk factors for cardiovascular disease with     increasing prevalence worldwide and insulin resistance is central to its pathophysiology and     multi-organ deleterious effects. One of the most affected organs, the heart, undergoes a     remodeling process with an increase in fibrous tissue that impairs global cardiac function.     Considering that myocardial fibrosis increases myocardial stiffness, one important     determinant of diastolic function, it probably contributes decisively to subclinical left     ventricular diastolic dysfunction (DD) and heart failure with preserved ejection fraction in     patients with MS.      Since insulin resistance is a dominant player in the pathophysiology of MS, improvement of     the metabolic profile of these patients with metformin might be associated with favorable     remodeling of myocardial structure and an improvement in myocardial function. Metformin is a     widely used drug to treat type 2 diabetes mellitus and is considered an option in the     treatment of high-risk non-diabetic patients with MS, in addition to lifestyle counseling     including a healthy diet and physical activity.      In this way, we aim to: i) assess if treating non-diabetic patients with MS and DD with     metformin in addition to lifestyle counseling decreases cardiac fibrosis and improves     diastolic function and assess its impact in functional capacity and health-related quality of     life (HRQoL); ii) evaluate if biomarkers of cardiac remodeling and inflammation are     predictive factors of response to metformin treatment in these patients.      This is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial (scheduled     follow-up of 24 months) with 2 arms: lifestyle counseling only and lifestyle counseling plus     metformin (maximum dose of 1000mg twice daily).      The primary endpoint will be change in change in mean of septal and lateral early diastolic     mitral annular velocities (E') (at the end of the 24 months of follow-up).      The secondary endpoints will include a composite of major cardiovascular events; diastolic     function parameters at rest; plasma levels of insulin, glucose, insulin resistance index,     NTproBNP, high-sensitivity C-reactive protein, tumor necrosis factor-α (TNFα), tissue     inhibitor of matrix metalloproteinase type 1 (TIMP1) and growth differentiation factor-15     (GDF-15); functional capacity; epicardial, pericardial and abdominal adipose tissue volumes,     and coronary calcium score; HRQoL.   "
96922|NCT02017548|"     In a multicenter, randomized clinical trial of default options in advance directives among     patients with incurable diseases, we will determine whether this simple and readily scalable     intervention can improve patients quality of life and reduce resource utilization without     reducing the number of days that patients are alive and living outside of an acute-care     hospital.   "
96923|NCT02017535|"     The purpose of the study is:        1. To find out how long teenagers getting talk therapy (interpersonal psychotherapy) for          depression should get therapy before the therapist decides whether or not the teenager          is improving enough, and        2. To compare two ways of providing treatment to teenagers who have not improved enough.   "
96924|NCT02017522|"     In a study of Cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to     examine inflammation.   "
96928|NCT02017470|"     This research focuses on health needs, constructed meanings of health, and meaningful health     promotion tactics among women who are heart disease patients. Women with heart disease are     considered as a highly vulnerable group for cardiovascular disease-related deaths in     Singapore. Because the culture-centered approach has previously demonstrated that     community-driven participatory processes of the Culture-Centered Approach (CCA) foster     positive changes in health outcomes, this project highlights involvement of community members     in developing effective health promotion regarding heart health. Rather than relying solely     on interventions created by outside experts, The investigators aim to engage in Heart Health     promotion that is meaningful through the involvement of these community members in processes     of change.      Thus, the investigators seek to engage these women who are heart disease patients in     developing a heart health intervention that is beneficial to them. Through in-depth     interviews, focus groups, the formation of advisory boards, and community-wide dialogue     workshops led by these women, the investigators seek to identify specific heart health     promoting strategies and tactics that are meaningful to the lived experiences of the women.     As part of the overall solution, this project will work alongside the Women's Heart Health     Clinic to create training materials and disseminate findings based on our analysis.      Methodology:      As far as the methodology, the investigators are using the Culture-Centered Approach (CCA) as     well as using biomedical measures for evaluation. First, an advisory board will be formed to     inform each step of our methodology and data analysis. First, the investigators will     randomize one group of patients into the control group and one group into the experimental     group. The investigators will conduct baseline measures for both groups. For the control     group, the investigators will measure biomedical data at 3 times (3 months, 6 months, and 12     months). For the experimental group, the investigators will create advisory board that will     consist of approx. 4 physicians and 6 patients. In-depth interviews will be conducted with     women who have experienced CVD and who live in Singapore. Each interview will last a maximum     of 90 minutes. Interviewees will be asked questions about how they understand health, their     health experiences, and the obstacles they face in accessing health care in Singapore. Data     from the interviews will be analyzed with the advisory board and will be used to guide     discussion for the focus groups of women in the experimental group.      Focus group sessions, each lasting a maximum of 90 minutes, will be conducted with the     patients in the experimental group. In each session, the participants will collectively     develop potential solutions for the issues that emerged during the earlier interviews.During     the one-year period of study, a participant in the experimental group can participate in one     or many of the one-on-one interviews, focus groups, or other activities planned based on the     feedback of the participants. Based on the information given in the interviews, advisory     board meetings, and focus groups, an intervention will be designed and carried out for the     experimental group. This group will also be evaluated at 3 time points (3 months, 6 months,     and 12 months) in addition to baseline.   "
96930|NCT02017444|"     Assessing the safety and effectiveness of a 11-βhydroxysteroid dehydrogenase type 1 inhibitor     (AZD4017), in a placebo controlled trial, in acute idiopathic intracranial hypertension (IIH)     IIH is a condition of young, overweight women with characteristic raised intracranial     pressure (pressure around the brain) leading to papilloedema (swelling of the nerve supplying     the eye), visual loss and headaches. Medical literature (Cochrane review) demonstrates there     is little evidence for the treatments used for IIH. Weight control appears the most effective     method of improving symptoms but weight loss is difficult to maintain. 11β-hydroxysteroid     dehydrogenase type 1 (11β-HSD1) is an enzyme which regulates local steroid levels and our     previous research suggests it may influence the production of brain fluid(cerebrospinal fluid     or CSF). 11β-HSD1 levels fall with weight loss and this is associated with with decreased     intracranial pressure.      Our primary outcome is to determine whether AZD4017, an inhibitor of 11β-HSD1, will reduce     the pressure in the brain and as a consequence improve IIH. Patients are eligible to enter     the study if they are between 18-55 years old with acute (<6 months) IIH, signs of active     disease (papilloedema and raised CSF pressure (>25 cmH20)), no other major illnesses and have     no plans for pregnancy during the study period.      This is an MRC funded single centre, phase II, double-blinded, randomised control drug trial.     It will be conducted at the University Hospital Birmingham and the University of Birmingham     will act as Sponsor. Eligible participants will be randomly assigned to AZD4017 or a placebo     ('dummy' with no active drug) for 3 months with a follow up a month later. Investigations     during the study will include bloods, urine samples, pregnancy tests, lumbar punctures, DXA     scans and small fat/skin biopsies. Participants will benefit from increased monitoring and a     potential improvement in their condition.      We hypothesise that specific inhibition of 11β-HSD1 will decrease intracranial pressure and     consequently treat patients with IIH, thus opening a new and entirely novel therapeutic     avenue.   "
96931|NCT02017431|"     The study probes the effects of combined exposures to diesel exhaust and allergens on lung     function and on the immune system, specifically focusing on the ability of a particle     depletion technique to attenuate effects we and others have seen previously. Individuals are     exposed to either filtered air (FA), carefully controlled levels of diesel exhaust (DE) or     particle-depleted diesel exhaust (PDDE) in our exposure chamber, after which the     investigators will administer an inhaled allergen challenge. 48h later, a procedure called     bronchoscopy is used to collect samples from the lungs. After 1 month, the entire procedure     is to be repeated with one of the alternate exposures. This will be repeated 4 times (4     exposures; 2 filtered air, 1 diesel exhaust, 1 particle-depleted diesel exhaust)   "
96932|NCT02017418|"     This study was designed to test whether two zeaxanthin formulations (supplements containing     different nutritional compounds with zeaxanthin and omega fatty acids being the primary     ingredients of interest) influenced visual motor function. Visual motor function refers to     the processing speed of the visual system and how individuals respond behavioral to visual     stimuli (e.g., reaction time).   "
96933|NCT02017405|"     The purpose of this study is to determine the digestibility of serum-derived bovine     immunoglobulin protein isolate in healthy adults. The information generated may help     elucidate SBI's mechanism of action.   "
96934|NCT02017392|"     The purpose of this study is to determine whether the compound lidocaine cream is effective     in preventing postoperative agitation in patients with endotracheal intubation for general     anesthesia.   "
96935|NCT02017379|"     This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs     (Drugs which are known to speed up the emptying of the stomach or in other words to move the     blood out of the stomach faster) given before endoscopy to patients with upper     Gastrointestinal bleeding compared to patients who will not receive either of these     medications before their endoscopy.   "
96936|NCT02017366|"     It is well known that there is a considerable postoperative weight loss in patients     undergoing esophageal resection for cancer.      We believe that this weigh loss can be limited by administering postoperative enteral feeding     (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.      We hypothesize that patients undergoing esophageal resection for cancer will have a better     overall survival with postoperative additional enteral feeding than when on regular oral diet     alone.   "
96937|NCT02017353|"     This therapy aims to determine whether curcumin can inhibit tumor induced inflammation in     patients with endometrial carcinoma. In addition, curcumin could possibly induce a better     functioning of chemotherapy and a decrease in toxicity from chemotherapy. Various studies     have demonstrated that curcumin can have an effect on tumor growth and the development of     metastases.   "
97263|NCT02013089|"     Hypothesis: Different patients have different biomarkers, if doctors know about the     biomarkers of patients; they may be able to prescribe a regimen that is better suited to the     patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and     Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if     the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer     who had failed from all standard and available regimens.   "
96938|NCT02017340|"     Alzheimer's disease (AD) is an ever-increasing public health concern among the aging     population and is the most common form of dementia affecting more than 15 million individuals     worldwide and around 5 million Europeans. The direct and indirect costs of AD and other     dementias amount to more than €440,000 million each year (www.alz.org, 2010).      Even modest therapeutic advances that delay disease onset and progression could significantly     reduce the global burden of the disease and the level of care required by patients. While     there are symptomatic-based drug therapies available for AD, these medications do not prevent     the disease process itself. There is therefore an imperative to develop new treatments for AD     that have disease modifying effects. This double-blind placebo controlled study will test the     efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment     period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a     licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in     mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical     studies with this medication have shown stabilization of cognitive decline and reduced     incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female     patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities     and frailty will be included in the study. If this trial is successful, nilvadipine would     represent an advance in the treatment of AD patients and would have a major impact on the     health and social care costs incurred in Europe by this neurodegenerative disorder.     Furthermore, the creation of the NILVAD network will support future clinical trials and     research innovation in AD across Europe.   "
96998|NCT02016560|"     This is a cross-sectional and longitudinal study that will evaluate imaging characteristics     of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and     Alzheimer's disease (AD) subjects.   "
96939|NCT02017327|"     Primary objective:      The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01%     and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival     hyperaemia in the worse eye at Day 84.      The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).   "
96940|NCT02017314|"     The aim of the study is to observe if any correlation between Body mass index and VAS values     exists in patients who has gone under abdominal surgery.      Group I : Patients with BMI<30 Group II: Patients with BMI between 30 and 34.9 Group III:     Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V     : Patients with BMI >50      After the end of surgery patients will be extubated and in the recovery room morphine PCA     (patient-controlled analgesia) treatment will be started according to their adjusted body     weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment.     VAS values and Delivery and Demand of the PCA and additional need for analgesics will be     recorded in the first 48 hours.   "
96941|NCT02017301|"     Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often     present with malnutrition, and due to the in-hospital stay, their nutritional intake can vary     widely, with several periods of fasting, and sometimes insufficient nutritional support.     Therefore patients are prone to develop malnutrition or, the already present malnutrition     worsens its status.      Our aim is to evaluate the daily changes in nutritional status in patients with acute     decompensation of cirrhosis and evaluate the changes in plasma and serum biomarkers.   "
96942|NCT02017288|"     Background:      - Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer     develops over several years, beginning as white or red patches in the mouth or throat that     become growths. It can also cause a condition that leads to rigidity of the cheeks. The     growths can be identified when a doctor looks into a person s mouth. It is currently not     clear why some people with abnormal growths progress to cancer while others do not.     Researchers want to better understand why some patients with early abnormal growths get late     abnormal growths. They also want to understand why some people get abnormal growths again,     even after they receive treatment.      Objectives:      - To understand why some people with precancerous lesions in their mouth develop cancer while     others do not.      Eligibility:      - Adults 21 years and older, some with abnormal growths in the mouth, some without any, and     some with head and neck cancer.      Design:        -  Participants will visit a hospital in Taiwan 2 times.        -  At the first visit, participants will answer questions about their health, lifestyle,          and family medical history. A doctor will examine the participant s mouth and take a          small piece of any growth they see. They will do this with a brush. They will also          photograph the participant s mouth. Participants will also give blood and saliva          samples, plus a small sample of a mouth rinse.        -  Participants who are diagnosed with a late abnormal growth that is not cancer will          return for a second visit. They will answer the same questions and undergo the same          procedures as at the first study.   "
96943|NCT02017275|"     PANDA III is sought to investigate the safety and efficacy of a PLGA-polymer with     electro-grafting base layer sirolimus-eluting stent (SES) versus a PLA-polymer SES at 12     months follow-up.   "
96944|NCT02017262|"     This project addresses the important public health need to reduce ethnic disparities in     depression care by pilot testing and refining a culturally tailored, low-cost intervention     for improving both depression and general medical outcomes among Latinos in safety net     primary care settings. Cuerpo Sano, Mente Sana is a newly developed, lay-led, group     self-management intervention that educates and empowers patients in their own health care and     has the potential for widespread implementation and sustainability in primary care because it     is responsive to patient, provider, and system preferences and needs. After completing an     assessment of study clinic sites, we will conduct a pilot test of Cuerpo Sano, Mente Sana     with 30 low-income, Spanish-speaking primary care patients. After reviewing pilot findings,     we will revise the intervention and study plan, and will conduct a second pilot trial. After     reviewing findings from this second trial, we will finalize the intervention and study plan     in preparation for larger studies to test Cuerpo Sano, Mente Sana versus other interventions     for addressing depression among Latinos in safety net primary care.   "
96988|NCT02016690|"     This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014     and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and     effectiveness of palivizumab for the prevention of serious lower respiratory tract infection     caused by RSV in participants 24 months of age and under, who have an immunocompromised     medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other     types of immunodeficiency; HIV infection; recovering from organ or bone marrow     transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants)     or who have Down syndrome.   "
96945|NCT02017249|"     The purpose of this study is to learn more about the ability of a substance called arginine     to improve the functioning of the immune system in people with a certain type of brain tumor.     This could lead to improvements in a type of treatment for brain tumors called immunotherapy.     The immune system includes organs, cells, and substances in the body that fight infection and     disease. Immunotherapy is a type of treatment that uses the immune system as a tool to seek     out and destroy abnormal cells. Immunotherapy requires that the immune system be working     properly. Arginine is a normal component of protein (an amino acid) that we all consume in     foods such as red meat, poultry, fish, and dairy products and that our bodies can make.     Arginine helps the immune system function normally. Recent research has shown that certain     types of brain tumors decrease the amount of arginine in the body leading to impaired immune     system function. This may interfere with the ability of immunotherapy to fight abnormal     cells. We would like to see if giving people with brain tumors arginine in powder form will     make their immune systems work better.   "
96946|NCT02017236|"     The purpose of this study is to evaluate to determine the effect of food on the PK of a     single dose of 600 mg Volitinib and its two major metabolites in healthy subjects.   "
96956|NCT02017106|"     Varicose veins of the leg often have superficial tributaries, which are often symptomatic and     a major reason for coming to the doctor. When treating the main varicose vein inside the leg,     some doctors prefer to remove these tributaries while others prefer to leave them. This trial     aims to see if it is better to remove these veins at the time of the first laser procedure or     better to leave them and only remove them when asked.   "
96947|NCT02017223|"     This project proposes to use mobile devices to develop new tools for pediatric obesity     prevention and treatment targeting underserved minority adolescent populations at high risk     for obesity and related diseases. We will use off the shelf, validated and wearable wireless     sensors to measure physical activity, blood pressure, sleep, heart rate, galvanic skin     response and blood glucose levels and communicate the measured information to a mobile phone     using a wireless interface. This will deliver a record of behavior and health data that is     time-stamped, synchronized, and geographically localized using GPS to a secure server. Data     will then be analyzed and displayed to participating health professionals to provide them     with readily interpretable records of continuously monitored energy expenditure, recorded and     synchronized with other essential biological, behavioral and geographical data. To accomplish     this project, 50 African American and Hispanic youth (50% female, ages 12-17) will be     recruited into the research in advisory capacities, to test the sensors during development,     and to wear the sensors for three non-contiguous weeks. To test the sensors prior to use with     minority youth, 30 college students age 18 and above will be recruited to try out the sensors     in and outside of the laboratory in order to make sure that all sensors are in perfect     working order before testing them in minority youth populations. An advisory group of medical     professionals will be assembled to guide us through the process of developing a web interface     that will ensure that the right information will be displayed in an easily interpretable     fashion. The advisory group will participate in regular meetings to develop and test the web     interface. Using the data acquired, health professionals will be able to visualize average     amounts of physical activity, sleep, sedentary behaviors (daily or weekly) as well as daily     patterns. Average blood glucose, heart rate, and stress levels (daily or weekly) as well as     daily patterns will also be available. Practitioners will be able to see when and where     activity and metabolic events are occurring, enabling preemptive and preventive strategies as     well as targeted interventions to prevent and treat pediatric obesity in underserved and     at-risk minority youth.   "
96948|NCT02017210|"     People who are overweight and/or obese usually are insulin resistant and so are at risk of     type 2 diabetes. However, research has shown that some overweight and/or obese people remain     insulin sensitive and healthy despite their weight.      The investigators hypothesise that insulin-sensitive overweight and/or obese people maintain     their insulin sensitivity and metabolic health over time. The investigators also hypothesise     that the preservation of insulin sensitivity will be determined by key metabolic factors.   "
96949|NCT02017197|"     The purpose of this study is to assess whether the switch from branded to generic warfarin or     between different generic warfarin tablets may cause fluctuation in the results of     coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing     them to unnecessary risks.   "
96950|NCT02017184|"     Soldiers are required to perform and maintain alertness in difficult environmental     conditions. The sensor examined in this trail may indicate body core temperature elevation     during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting     and walking in thermoneutral and hot environments with two core temperature sensors. The     results obtained from them will be compared.   "
96951|NCT02017171|"     Despite improvements during the past 20 years in blood glucose and blood pressure control,     diabetic kidney disease remains one of the most important causes of health problems in     patients with diabetes. Novel treatments to complement blood glucose and blood pressure     control are urgently needed. The goal of this study is to see whether a medication called     allopurinol may help prevent loss of kidney function among people with type 1 diabetes.     Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a     disease characterized by arthritis, especially of the foot joints. There is evidence     suggesting that allopurinol might also be useful in people with diabetes who have normal or     moderately impaired kidney function to decrease the risk of developing advanced kidney     disease in the future. To prove this beneficial effect of allopurinol, we will be conducting     an international clinical trial at eight diabetes centers, enrolling approximately 480     patients with type 1 diabetes who are at increased risk of developing kidney disease.     Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for     three years, during which they will be followed through periodical visits. To prevent any     possible bias, neither the participants nor the clinical staff knows who is taking     allopurinol and who is taking the placebo. Kidney function will be measured at the beginning     and at the end of the treatment period to see whether patients taking allopurinol experience     a slower loss of kidney function over time as compared to those taking the inactive pill. If     this trial is successful, the reduction in health problems resulting from the prevention or     delay of kidney function loss due to the use of allopurinol would have a major impact on the     lives of type 1 diabetic patients as well as on society at large, significantly reducing the     human and financial costs associated with diabetic kidney disease. Because of the emphasis on     early intervention, the proposed trial, if successful, will establish a new paradigm in     treatments to slow or prevent progression towards end stage kidney disease in type 1 diabetes     far beyond anything achieved to date.   "
96952|NCT02017158|"     The purpose of this study is to develop, disseminate, and evaluate a web-based nutrition and     gardening game using interactive, multiplatform and mobile gaming, rich narrative, a     pedagogical agent, meaningful play, and experiential learning to prevent/treat obesity in     minority 3-5th grade youth and their families.   "
96953|NCT02017145|"     The purpose of the current work is to determine the efficacy of the re-application of     surgical prep solution in decreasing surgical site bacterial contamination following lower     extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding     the surgical site during the initial healing phases would theoretically decrease the rate of     infection in high-risk persons.   "
96979|NCT02016807|"     RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an     effective single therapy approach for the management of chemoradiation mucositis, treating     and preventing its occurrence in the oral cavity, esophagus, stomach, small and large     intestine.      PURPOSE: This observational multi-phase trial is studying how well polymerized (cross-linked)     sucralfate malate paste (ProThelial) works to prevent and treat mucositis in adult patients     who are to receive or have received chemo/radiation therapy that have caused or is     anticipated to cause mucositis in the oral cavity, esophagus, stomach, small or large     intestine. The Phase IV study addresses prevention and treatment in the oral cavity. The     Phase I study addresses prevention and treatment in the esophagus, stomach, small and large     intestine.   "
96954|NCT02017132|"     Pomegranate has gained widespread popularity since the health effects of the whole fruit, as     well as its juices and extracts, have been studied in relation to a variety of chronic     conditions such as hypertension, diabetes, obesity, cancer and cardiovascular disease.      The fruit consists of peel, seeds and berries or arils. The peel is rich in minerals and     compounds such as polyphenols, but is not an edible part of the plant. In order to harness     the benefits of all parts of the fruit, the whole fruit can be crushed and powdered and then     easily consumed as pomegranate extract capsules.      Pomegranate has been shown to be effective at reducing cardiovascular disease risk factors,     particularly with respect to decreasing blood pressure and increasing insulin sensitivity.     Dietary polyphenols may also suppress body fat growth. Recently, positive effects on fat     reduction have been shown using pomegranate and its extracts. In animal models it has been     shown for both extract and leaf that there were significant decrease in food consumption and     body weight, inhibiting the development of obesity. In the few human studies, there appeared     to be a trend towards a reduction in waist circumference and fat mass, plus a halt in body     weight increase, for both juice and seed oil.      This parallel, double blinded, randomised, placebo controlled trial aims to confirm previous     results concerning the effect of whole pomegranate fruit on biochemical and physiological     markers using a new pomegranate extract and to conduct original work to explore its effect on     body weight, measurements and fat mass. Any similar interventions have not been double     blinded or used pomegranate in extract form. Changes in physiological and biochemical markers     will also be investigated.      The study hypothesis is that pomegranate extract will reduce BMI and body weight, fat mass,     body measurements and blood pressure.   "
96955|NCT02017119|"     Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a     first line treatment for HE, but the adherence to this treatment is relatively low, due to     side effects such as diarrhea, distention, etc.   "
96957|NCT02017093|"     The purpose of this pilot study was to explore the impact of enhancement of the velocity     component error in the course of reaching movements of the impaired/hemiparetic limb in an     acute stroke subject. We hypothesized that the method would shift velocity profiles toward     the optimal, resulting in a reduction in error. A prototype robot. This robotic device system     has a two-dimensional motor, basic measurement capacities, and a robotic arm which is engaged     to the subject's upper-limb in a sitting position.      The enhancement of the velocity component error would shift velocity profiles toward the     optimal, resulting in a reduction in error.   "
96958|NCT02017080|"     Non invasive methods: maternal antithyroid antibodies and ultrasound measurement of the fetal     thyroid gland could be an important tool for detecting fetal thyroid dysfunction in mothers     with autoimmune thyroid disease.   "
96959|NCT02017067|"     Previous studies have demonstrated that resistance training (RT) is beneficial to increase     muscle strength, improve functional ability and the ability to rapidly produce force, known     as the contractile rate of force development (RFD) in older adults. However, much less     research has focused on the effect of RT on the lower extremity muscle strength, contractile     RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially     for osteoporosis (OP) (or osteopenia) or knee osteoarthritis (KOA). Therefore, the purpose of     this study was to investigate the effect of RT on the lower extremity muscle strength, RFD     and impulse in middle-aged and older people with musculoskeletal conditions, especially for     OP and knee OA (KOA). The investigators hypothesized that such a training program would lead     to induce not only specific muscle strength enhancement but also an increment in contractile     RFD and impulse.   "
96960|NCT02017054|"     The purpose of this study is to assess the feasibility of performing repetitive coronary     angiograms via the radial approach   "
96961|NCT02017041|"     The purpose of this study is to evaluate the usability of an interactive smartphone     application (app) designed to engage and support patients receiving bup/nal.   "
96962|NCT02017028|"     The aim of this study is to investigate the relation between the previous presence of     endothelial dysfunction and the development of radial artery vasospasm during the     trans-radial coronary evaluation.   "
96963|NCT02017015|"     The purpose of this study is to determine the safety and efficacy of nab-paclitaxel combined     with gemcitabine in Chinese patients with metastatic pancreatic cancer.   "
96964|NCT02017002|"     Esophagectomy for esophageal cancer is a technically complex procedure which is associated     with high perioperative mortality, even in high volume centers[1]. To facilitate the     postoperative recovery of esophagectomies patients by reducing surgical trauma, an increasing     number of surgeons have attempted minimally invasive esophagectomy (MIE) to treat patients     with esophageal cancer.[2-10] However, there is no consensus regarding the optimal method for     performing an esophagectomy with the minimally invasive surgical technique. In addition, the     benefit of this approach has not been well confirmed based on the limited retrospective     comparative studies at the present time [3, 11-12], although its potential benefit improving     the immediate postoperative including the total morbidity and pulmonary complication has been     demonstrated by meta-analyses[13]. Especially it is unclear whether adding laparoscopic     procedures in MIE can contribute to further improvement of the perioperative outcome of the     patients.[3] Previously, the investigators have found that adding of laparoscopic procedure     in performing the esophageal reconstruction procedure after VATS esophagectomy can provide     further benefit in reducing the postoperative major complications and fasten the     postoperative recovery16. For the most cases, the patients was receiving tri-incision     esophagectomy, i.e. VATS esophagectomy in the chest, laparoscopic gastric mobilization in the     abdomen and left cervical esophagogastrostomy. In such circumstances, a cervical incision was     required for esophagogastrostomy after esophagectomy and gastric mobilization. However, for     the patients with lower-to mid third esophageal cancer, some surgeon performed Ivor Lewis     esophagectomy, which performing the esophagogastrostomy in the chest after gastric     mobilization without cervical incision wound. Although both of these procedures have been     demonstrated to be feasible and safe, there is much debate about the advantage and     disadvantage of these two approaches. For tri-incision esophagectomy, patients have the     chance to have cervical lymph node dissection and the esophagus can be resected up to the     neck. However, it is more time-consuming and associated with more surgical trauma by adding a     cervical incisional wound and more tissue dissection around the cervical trachea as compared     to that done by Ivor Lewis esophagectomy. In contrast, for the Ivor Lewis esophagectomy, the     resection of esophagus was limited to the level of thoracic inlet and cervical lymph node     dissection was impossible unless a neck incision was further created. However, it takes less     time in performing the whole procedure by saving a neck incision.   "
96965|NCT02016989|"     The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It     is a double blinded comparison of epithelial defect in two groups of patients randomized     between CACICOL20 and physiological salt solution.   "
96966|NCT02016976|"     The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%)     cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a     permanent pacemaker.   "
96980|NCT02016794|"     Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment     may require anterior decompression and fusion, which usually is established with a cage     implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.   "
96967|NCT02016963|"     This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in     healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months     ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable     female subjects) will receive a second dose of raxibacumab equal to that of the previous dose     >= 4 months following the first dose. Subjects will remain in house from Day 0 until Day 1     and will be followed for 70 days after receiving the second dose of raxibacumab. Raxibacumab     has been shown to provide improved survival in rabbit and monkey anthrax spore challenge     studies. Preliminary data from our rabbit pivotal efficacy study showed significant survival     benefit for raxibacumab over placebo. Exposure to anthrax and resulting clinical disease can     occur more than once, especially in individuals who do not develop protective immunity.     Hence, if clinically indicated for the treatment of anthrax, there may be a requirement for     the repeat administration of raxibacumab. The rationale of the study is to evaluate the     immunogenicity and safety of repeat administration of raxibacumab with a >= 4 month interval     between dosing.   "
96968|NCT02016950|"     Investigators seek to observe the long term patterns of arrhythmias detected by permanent     pacemakers.   "
96969|NCT02016937|"     In our study we aimed to compare the lactation process by mothers who were undergoing     elective Caesarian section under general anesthesia, spinal anesthesia, epidural anesthesia     and normal vaginal birth.   "
96971|NCT02016911|"     This trial is conducted in Europe. The aim of the trial is to investigate the     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of     oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic     impairment compared to subjects with normal hepatic function.   "
96972|NCT02016898|"     The primary focus of this study is to assess intraocular pressure and complication rates     between patients who receive mitomycin-C using a sponge versus no-sponge.   "
96974|NCT02016872|"     The purpose of this study is to help researchers investigate if a new imaging agent named     18F-FMISO can predict if patients with lung cancer will respond to standard therapy, as well     as whether disease will reoccur in the future. The study will also investigate whether a     18F-FDG PET scan in the middle of radiation treatment can predict if lung cancer will respond     to standard therapy. Information obtained from this study may help doctors design future     studies in which they may target tumor areas that do not respond to therapy or may likely     reoccur in the future.   "
96975|NCT02016859|"     Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed that     this value may be another prognostic factor in critically ill patients such as those admitted     to ICU, or those with neutropenic Fever.      The purpose of the study is to check if the IPF may be used as a prognostic Factor in these     patients   "
96976|NCT02016846|"     Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity.     However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose     metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will     improve glucose metabolism in patients with high risk for diabetes morbidity, treated with     glucocorticoids.   "
96977|NCT02016833|"     This study is a clinical study aiming at establishing immunological assays for the     qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune     responses in cancer patients. Such a study will allow the development of suitable     immunological tools to be used in assessing response in a subsequent phase I study aiming at     evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing     tumors. In addition, this study will help defining the baseline cancer-associated immune     responses in the selected patient population.      Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this     study.      WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex     vivo and cultured IFNg ELISpot as well as tetramer staining.   "
96978|NCT02016820|"     The colonic microbiome is essential in health and disease, and is highly dynamic during the     first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor     antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the     pediatric colonic microbiome are unknown. This study will determine whether acid suppression     with these medications affects the microbiome of otherwise healthy children who are     prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the     duration and magnitude of microbiome changes.   "
96989|NCT02016677|"     The purpose of the study is to collect data regarding the aesthetic outcomes of patients who     had breast reduction surgery and /or mastopexy in terms such as scaring, patient     satisfaction, breast ptosis assessment including taking photographs and filling     questionnaires.   "
96990|NCT02016664|"     Oral ketamine is increasingly used by doctors to both reduce the amount of narcotic pain     medication consumed and to improve chronic pain management in difficult cases. How much is     absorbed when taken orally, as opposed to intravenously ,is unknown. Ketamine may cause     sedation, and occasionally cognitive impairment. Therefore, there are safety concerns     associated with its usage as an out-patient may engage in activities where cognitive     impairment is dangerous,such as driving. This study is designed to measure the plasma     concentrations of ketamine and its active metabolite, norketamine, in people taking low dose     oral ketamine for chronic pain. The goal of the study is to verify that low dose oral     ketamine produces plasma concentrations below the level associated with toxic symptoms,and     thus can be safely used long-term for the treatment of chronic pain .   "
96991|NCT02016651|"     Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving     mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific     marker for aspiration. The objective of this study is to examine if TA pepsin will change     when ventilated premature infants are positioned in two different positions; on their back     vs. on their right side.   "
96992|NCT02016638|"     Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in     causation of pregnancy related disorders is yet to be determined. OSA can complicate     pregnancy given the risk factors of weight gain, upper displacement of the diaphragm, and     hormonal-induced hyperaemia of the nasopharyngeal passages. SDB confers the risk of     hypertensive disorders of pregnancy and is associated with adverse maternal and foetal     outcomes.      The study would involve pregnant females which would be prospectively followed in pregnancy     and post partum to know the prevalence of sleep disorders in pregnancy. Diagnosis of sleep     disorders would be confirmed by overnight polysomnography and ambulatory blood pressure     monitoring. Pregnancy outcomes, both maternal and fetal would be recorded and its relation     with sleep disorders in pregnancy would be analysed.   "
96993|NCT02016625|"     The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir     (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus   "
96994|NCT02016612|"     Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help     shape and hold the breast up on the chest preventing re-stretching and bottoming out of the     breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be     measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D     Imaging system reporting the amount of breast tissue above and below the nipple level.   "
96995|NCT02016599|"     Prematurity is a very important problem in this country. Prematurity can cause problems with     organ (such as the brain, heart, kidneys) growth and development. A very important part of     keeping premature babies healthy is ensuring good blood flow to all of these organs.      Some premature babies have problems with their hearts and getting enough blood out to the     rest of their bodies. This problem is referred to as hypotension (low blood pressure) and is     found by looking at blood test values and while examining the baby. These babies will need     medications to help their heart deliver blood to all of the important areas in their bodies.      Babies who have hypotension requiring medications tend to have more problems than premature     babies that don't need hypotension medication. Some of these problems include a higher risk     of bleeding into their brain, kidney problems, liver problems, intestinal (gut) problems     causing difficulty tolerating feeds, and a very dangerous infection of their intestines. Some     long term effects include hearing loss, developmental delay, and learning problems in the     future that are worse than other premature babies who did not have hypotension. Hypotensive     premature babies also have a higher risk of death.      The cause of hypotension in the first week of life is still not known. We know that babies     have to get used to being in the outside world instead of in the womb. A lot of changes with     the heart and lungs have to happen for them to not be affected by that transition. If we     could gain a better understanding of those changes, we might be able to prevent some of these     issues from happening.      This study will look closely at premature babies with and without hypotension to assess the     heart and lung changes in the first week of life. To do this, we will use monitoring machines     and tests to get a better idea of all the changes that happen. This information will help all     neonatologists who care for premature babies.   "
96999|NCT02016547|"     Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of     symptoms onset. Efficacy of this therapy is limited in the setting of large artery     occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions     (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is     linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits     IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90%     with last generation devices. A recent meta-analysis has shown that the best candidates for     thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is     increased in association with antiplatelets such as abciximab. The aim of the study was to     assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI     score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical     trial versus the gold standard for acute ischemic stroke revascularization strategies using     IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy     with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms     onset.   "
97000|NCT02016534|"     This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG     337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal     adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the     objective response rate of AMG 337 by tumor type.   "
97029|NCT02016157|"     In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as     an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis     and for short-term effects on the periodontal microflora.   "
97030|NCT02016144|"     This study is intended to find the optimal length of pre-inserted ETT for nasal fiberoptic     intubation and the equation to predict it.   "
97769|NCT02006459|"     We want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated     glucose disposal. In order to do so we will perform oral glucose tolerance tests and     isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy     controls.   "
97001|NCT02016521|"     In humans, the primary means of cooling the body during exercise is through the evaporation     of sweat from the skin surface. Clothing represents a layer of insulation that hinders the     evaporation of sweat from the surface of the skin. It follows that clothing that imposes the     least amount of resistance to evaporative heat loss may prove beneficial to the     thermoregulatory, physiological and perceptual response to exercise, particularly in elite     endurance-trained athletes. Thus, the purpose on this study is to examine the influence of     wearing a sportswear garment made of a fabric (100% nylon) with superior evaporative     characteristics on detailed thermoregulatory, cardiorespiratory, metabolic and perceptual     responses to maximal exercise testing at normal room temperature and relatively humidity in a     group of 25 endurance-trained cyclists and triathletes aged 20-60 years. It is hypothesized     that wearing a garment made of 100% nylon will improve exercise performance (e.g., exercise     endurance time) and that this improvement will reflect improvements in thermoregulatory,     cardiorespiratory, metabolic and perceptual responses to exercise. Athletes will be recruited     via contact with coaches of the McGill University Cycling and Triathlon teams as well as     through contact with coaches of competitive cycling and triathlon teams/training groups in     the Montreal and surrounding area. Initial contact will consist of a thorough explanation of     the study procedures and pre-screening for the inclusion/exclusion criteria prior to study     consent by the Principal Investigator and/or his delegate, either in person or by telephone     or email. Eligible participants will visit McGill's Clinical Exercise & Respiratory     Physiology Laboratory on 3 separate occasions over a period of 10-14 days. Visit 1 will     include a maximal incremental bicycle exercise test for familiarization purposes and to     determine maximal power output (MPO). Visits 2 and 3 will include a constant-power-output     bicycle exercise test at 85% MPO under one of two conditions, in randomized order: (1) while     wearing a garment made of 100% polyester, i.e., placebo; and (2) while wearing a garment made     of 100% nylon, i.e., cooling fabric. At rest and during exercise at visits 2 and 3, detailed     assessments of core body temperature will be made using a temperature sensor placed into the     esophagus, while skin temperature and other physiological and perceptual parameters will be     measured using standard techniques.   "
97002|NCT02016508|"     The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of     unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with     geographic atrophy secondary to age-related macular degeneration.   "
97003|NCT02016495|"     To evaluate whether a combined supplementation of magnesium and lipoic acid is able to     significantly reduce the incidence of uterine contractions and related episodes of     hospitalization in pregnant women.   "
97004|NCT02016482|"     This study is being conducted to assess the safety and efficacy of adalimumab in participants     with nail psoriasis.   "
97005|NCT02016469|"     The purpose of this study is to evaluate the effect and safety of pectin and fecal microbiota     transplantation on patients with inflammatory bowel disease. The investigators hypothesize     that patients who take pectin can promote the migration of probiotics in intestine     engraftment, reduce pathogenic agents'adhesion to intestinal mucosa, cut down the     inflammation, and to maintain intestinal flora diversity and steady state in a long time.   "
97007|NCT02016443|"     Herniorrhaphy is the most frequent general surgical procedure. There are moderate pain     complaints after herniorrhaphy. Besides causing discomfort to the patients, pain, can delay     recovery and discharge and cause cognitive dysfunction and difficulty with returning to     normal daily activity.      A combination of analgesics with different effect sites can reduce the doses needed and     analgesic related side effects which is called multimodal analgesia .      Opioids, acetaminophen, nonsteroid anti-inflammatory drugs and cox-2 inhibitors, alfa-2     receptor agonists, steroids, gabapentin and pregabalin have been used for this purpose(4).      Tizanidine is an alfa-2 receptor agonist, and is used for musculoskeletal pain conditions.     Tizanidine reduced the local anesthetic requirement in spinal anesthesia.      The aim of this study is to investigate the hypothesis that: Tizanidine can reduce the pain     scores, analgesic consumption, analgesic related side effects and provide early return to     normal daily activity compared to placebo after inguinal herniorrhaphy.   "
97008|NCT02016430|"     Our group has recently identified the association between gut-flora-mediated carnitine and     phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and     cardiovascular risk. This study investigates the ability for dietary intervention to modulate     TMAO levels.   "
97009|NCT02016417|"     The present study is a randomized, control, phase II study of locally advanced nasopharyngeal     carcinoma (NPC) treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel，cisplatin     regimen plus 5-Fluorouracil (TPF) induction chemotherapy followed by concurrent     chemoradiotherapy.   "
97010|NCT02016404|"     The purpose of this study was to investigate the effects of low-sodium, high-potassium     condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.   "
97011|NCT02016391|"     The purpose of he study is to evaluate effects of dexmedetomidine on pain during     radiofrequency ablation of liver and kidney tumours.   "
97012|NCT02016378|"     This study investigates the effect of a computerized approach/avoidance retraining (aka     cognitive bias modification) over and above treatment as usual for adolescents in treatment     for substance use disorders. The computerized training entails viewing pictures of drug and     non-drug related stimuli, and then using the computer to make the drug pictures smaller and     the non-drug pictures larger. Participants will also take part in an EEG/event-related brain     potential assessment at the beginning and end of treatment to identify brain measures that     are associated with treatment response.   "
97013|NCT02016365|"     The primary objective for this study is to evaluate the efficacy of doxycycline +     ursodeoxycholic acid (UDCA) on disease progression in Transthyretin Amyloidosis (ATTR)     subjects with cardiomyopathy with or without neuropathy.   "
97014|NCT02016352|"     PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal     fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100     patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.   "
97015|NCT02016339|"     The purpose of this study was to compare the effects on sleepiness, quality of life,     depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP     adherence, 2 years after CPAP initiation.   "
97049|NCT02015897|"     The objective of this study is to investigate if Complete Decongestive Therapy is equally     effective whether it includes manual lymphatic drainage or not in the treatment of     lymphoedema among patients with breast cancer.   "
97545|NCT02009384|"     This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and     Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42     patients with radiographically measurable melanoma who have received at least one cycle of     Denileukin Diftitox will be enrolled and treated in the study.   "
97016|NCT02016326|"     The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to     an increased yield of adenomas in the colon among a population at increased risk for CRC.      Primary Outcome:      Adenoma Detection Rate (ADR — No. of colonoscopies at which one or more histologically     confirmed adenomas were found divided by the total no. of colonoscopies performed in the same     time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan     enhanced Colonoscopy.      Secondary Outcomes:        -  Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan          colonoscopy through out the entire colon.        -  Adenoma Detection Rate (ADR) in the right colon during the Second look, irrespective          of imaging modality.        -  Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were          found(regardless of the histological type) divided by the total no. of colonoscopies          performed in the Same time period) for each arm of the study in Right colon and          throughout the entire colon.        -  Mean number of adenomas per procedure for each arm of the study in right colon and          throughout the entire colon.        -  Mean number of polyps per procedure for each arm of the study in right colon and          throughout the entire colon.        -  Number of neoplastic lesions for each arm of the study in the right colon and throughout          the entire colon and number of neoplastic lesions missed on 1st pass of right colon.        -  Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study        -  Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the          study        -  Proportion of patients with Sessile Serrated Adenoma in each arm of the study        -  Proportion of patients with invasive cancer in each arm of the study        -  Presence or absence of learning effect while using this technology given that use of          I-Scan may train the human eye to better identify adenomas even without image          enhancement.   "
97017|NCT02016313|"     The purpose of this study is to determine whether physiotherapy is effective in the treatment     of a group of tinnitus patients with neck complaints.   "
97018|NCT02016300|"     The study will examine clinical and radiographic outcomes of microfracture surgery (a common     technique to address isolated areas of cartilage loss) in the knee used with or without     unloader bracing. Randomly selected patients will wear an unloader brace, which is designed     to take pressure off the area of the knee which underwent repair, for several weeks after     surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.      The surgery performed will be the same for all patients      The length of follow up and schedule of post-operative MRI will be the same for all patients.      The only difference in groups will be presence of absence of brace wear.   "
97019|NCT02016287|"     Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and     majority of them were intolerable to combined chemotherapy in China. In the investigators     phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and     efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a     definitive treatment for unresectable or medically inoperable tumors in ESCC patients.     However, not only the combination with chemotherapy, but also the boundaries of the clinical     target volume (CTV) are not internationally defined. The investigators then initiated a     prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as     the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy and     safety of the combination.   "
97020|NCT02016274|"     Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients     resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded     before, the combination of paclitaxel with cisplatin showed good tolerance and efficacy to     esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive     treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only     the combination with chemotherapy, but also the boundaries of the clinical target volume     (CTV) are not internationally defined. The investigators then initiated a prospective phase     II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line     treatment in metastatic esophageal carcinoma to observe the efficacy and safety of the     combination.   "
97021|NCT02016261|"     Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted     depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)   "
97022|NCT02016248|"     The purpose of this study is to determine the side effects and how effective CyberKnife     stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The     CyberKnife system is a new type of radiation machine that uses a special system to precisely     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be     minimal. The purpose of this evaluation is to see if this treatment will help patients with     your condition and to evaluate the effect of this treatment on your quality of life over     time.   "
97023|NCT02016235|"     Patients with Dent disease have suppressed levels of FGF 23 which contributes to     hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with     phosphorus may reduce hypercalciuria.   "
97024|NCT02016222|"     In the primary progressive multiple sclerosis, the detection of oligoclonal bands in     cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal     fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands     detection in tears is possible and useful for the diagnosis of multiple sclerosis.   "
97025|NCT02016209|"     platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer     (NSCLC) especially in lung squamous cell carcinoma has a better tumor response rate and     safety than solvent-based paclitaxel.However, the safety and efficacy is uncertain in     neoadjuvant therapy.   "
97026|NCT02016196|"     TIPS has been used for 20 years, as a means of reducing portal pressure in patients with     cirrhosis and portal hypertension related complications. TIPS proved more effective than     alternative treatments in controlling or preventing variceal bleeding and refractory ascites.     The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE).     Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of     previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of     post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.   "
97027|NCT02016183|"     To evaluate the safety and efficacy of long-term use of candesartan cilexetil /     hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD&HD in hypertensive     patients in the routine clinical setting   "
97028|NCT02016170|"     Recently, two new oral P2Y12 antagonists have been approved for clinical use: prasugrel, a     third generation thienopyridine, and ticagrelor, a first in class     cyclopentyltriazolopyrimidine (CPTP). These agents have been shown to be associated with more     potent platelet inhibitory effects compared with clopidogrel. In addition, both agents have     shown to be superior to clopidogrel in preventing recurrent ischemic events in the setting of     acute coronary syndromes (ACS). Understanding how to switch patients from prasugrel to     ticagrelor is an unmet need of clinical interest. The proposed PD investigation will have a     prospective, randomized, parallel design aimed to show that switching patients from prasugrel     to ticagrelor provides similar levels of platelet inhibition.   "
97031|NCT02016131|"     Re-hospitalization or re-intervention is sometimes necessary to treat type I and type III     endoleaks after EVAR for its persistent increasing of pressure in aneurysm lumen. Color-coded     quantitative digital subtraction angiography (CQDSA) provides an easy and quick way to     post-process the traditional digital subtraction angiography (DSA) which converts the peak     time of the maximal contrast medium intensity into a single polychromatic image. With the     help of CQDSA, a quantitative evaluation of the endoleak hemodynamics and a risk analysis of     the type I or type III endoleak could be performed during the EVAR procedure. This approach     may offer an objective assessment of the needs for immediate re-intervention, conservative     therapy or treatment endpoint in the future.   "
97032|NCT02016118|"     The purpose of this study is to assess the effectiveness and costs associated with the     intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS)     compared to the current standard management of recurrent urinary tract infections in adult     women diagnosed with recurrent urinary tract infections (RUTI).   "
97033|NCT02016105|"     The aim of the study is to demonstrate equivalent efficacy and similarity in the safety     profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type     psoriasis.   "
97034|NCT02016092|"     There are approximately one million Americans who live with Parkinson's disease with 50,000     new cases per year and this rate is expected to rise with an aging population. The underlying     pathophysiology and disease understanding of PD still remains elusive due to a combination of     disease complexity and lack of predictive capability of existing models.      The Berg Interrogative Biology™ discovery platform has demonstrated a unique capability in     producing drug targets and biomarkers that truly represent a disease phenotype. It has been     able to catalyze molecules now in late stage clinical trials in cancer and many pre-clinical     candidate therapeutics and biomarkers in endocrinology and central nervous system (CNS)     diseases. The platform is able to decipher normal versus disease signatures by integration of     data sets from the genome, metabolome, proteome, and lipidome in an agnostic manner that is     subjected to Bayesian Artificial Intelligence informatics. The resulting nodes are then put     back into wet-lab validation before proceeding to proof-of-principle pre-clinical testing.      By utilizing clinical data and specimens obtained by the medical specialists at The     Parkinson's Institute, along with Berg's Interrogative Biology™, this study aims to discover     a disease biomarker enabling the creation of a diagnostic test for Parkinson's disease.   "
97035|NCT02016079|"     The primary purpose of this study was to assess the effectiveness of omega-3 supplementation     on behavior problems in children.   "
97036|NCT02016066|"     The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the     drug) and immunogenicity (ability of a particular substance to provoke an immune response in     the human body) of CR6261 in Japanese healthy participants   "
97037|NCT02016053|"     500 patients with normal renal function will be prospectively studied and incidence, spectrum     and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients     with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be     prospectively studied for 1 year. Also biomarkers will be studied and validated as early     predictors of AKI (Acute Kidney Injury).   "
97038|NCT02016040|"     To evaluate the rate of patients without cancer detected by biopsies performed six months     after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®).      Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one     year. Evaluate the cost of hemi-ablation HIFU treatment.      A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory)     offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven     localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or     T2b ). Precise mapping and characterisation of the disease will be established using     multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.   "
97058|NCT02015780|"     To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic     control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in     participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4 or     5 on dialysis.   "
97059|NCT02015767|"     A patient registry to capture real life data and demonstrate the performance of roflumilast     (Daxas®) in a standard clinical practice.   "
97203|NCT02014077|"     This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to     reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is     that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less     complications and shorter hospital stay.   "
97039|NCT02016027|"     AIMS & OBJECTIVES To evaluate the effectiveness of administering of Carica folia mother     tincture to healthy individual's Platelet count.      Sample Details:- Students, Doctors and non-teaching staffs of Father Muller Homoeopathic     Medical College are taken up for the study. A minimum of 60 persons will be selected and will     be divided into two groups, Control & Experiment by lottery method.      Voluntary participation in the study is expected. 30 persons in each group. One group will     receive Carica folia mother tincture and other group will receive placebo.      Complete Blood count including platelet count will be measured for all 60 subjects before     commencing the study.      The drug namely Carica Folia mother tincture will be procured from Father Muller Homoeopathic     Pharmaceutical Division which compiles with the standards of Homoeopathic Pharmacopeia of     India.      Daily dosage -30 drops of Carica Folia mother tincture in 30 ml of distilled water morning     and night for 3days.      On 4th day complete blood count including platelet count will be estimated for all 60     subjects.      Research Methodology and Statistics:      Pre &Post with Control Design is done. Data from the sample is collected and is subjected to     Paired 't' test and unpaired 't' test.      HYPOTHESIS:-      Null hypothesis:      No significant changes in complete blood count and platelet count before and after the     intervention.      Alternate hypothesis:      There is significant variation in complete blood count and platelet count before and the     intervention.   "
97050|NCT02015884|"     At the hospital, the attacks against health professionals are becoming commonplace, making     working conditions difficult. The ophthalmological emergencies are a perfect testing ground     to evaluate the effectiveness of a series of original actions to prevent the occurrence of     violence against healthcare workers. The main objective is to measure the impact of an     integrated prevention of the occurrence of antisocial behavior or attacks against the     healthcare workers.      The prevention program combines five interventions (steps): 1) a computer sorting algorithm     and specific screens for calling patients in waiting rooms, 2) a clear signage to direct     patients between waiting rooms, treatment rooms and administrative et medical offices, 3)     Posts information on the activity of emergency services displayed on screens, in the waiting     rooms, 4) a mediator/go-between/conciliator, 5) and a dummy surveillance camera.      This is an interrupted time series study. All patients admitted to the ophthalmological     emergency unit of a university hospital located in Lyon, France, are included in the study,     from June 2013 to Sept 2015   "
97040|NCT02016014|"     Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first     step, and to evaluate the effect of adding this new tool of information and communication     technologies (ICT), to a standardized intervention to increase adherence to nutritional     recommendations of the Mediterranean diet and increase physical activity as primary endpoint.     Analyze adherence and intervention results from a gender perspective. Methodology:     Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at     assessing the effects of adding an TIC tool, developed for the Smartphone application     (intervention), in support of behavioral and educational recommendations (control) in the     increased physical activity and adaptation to the Mediterranean dietary pattern. Population:     1215 included subjects younger than 70 years from the project EVIDENT who agree to     participate. Measurement and interventions: Physical activity will be assessed with the     accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire     of adherence and a food frequency survey. It will also assess vascular structure and     function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media     thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED)     and exercise (based on PEPAF project), will be common to both groups. The intervention group     will be added training and use of an application on a Smartphone designed to promote healthy     eating and increased physical activity.   "
97041|NCT02016001|"     to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention     after 18 months of randomized controlled trial.   "
97042|NCT02015988|"     To test the hypothesis that early (within 5-21 days after index event) administration of     combined lipid-lowering therapy in extremely high risk population of patients with type 2     diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary     syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict     requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG     with diabetes.   "
97043|NCT02015975|"     Depending on the fracture pattern of patellar fractures tension band wiring, interfragmentary     screw fixation or combinations are common treatments. But there are several problems     associated with these techniques as fracture dislocation or loosening and perforation of the     wire. Furthermore an anatomic reduction with stable fixation in comminuted fractures is     almost impossible to achieve.      A new option in the treatment of patellar fractures is the locking plate osteosynthesis,     which provides a more stable fixation and higher mechanical strength in biomechanical tests     compared to classic tension band wiring. Due to various screw positioning a stable fixation     in comminuted fractures can be achieved and an early functional treatment with full weight     bearing reduces the loss of knee-motion. Furthermore a removal of the osteosynthesis seems     not to be essential anymore and the blood supply is not to be compromised.      Because of the absent of clinical evidence investigators want to evaluate the clinical     outcome after locking plate osteosyntheses in patellar fractures and compare patient     satisfaction, functional motion, complications and number of revisions with common     treatments.   "
97044|NCT02015962|"     Null hypothesis: There is no difference in the efficacy of IVPR and EPR during an episode of     hypokalemia.      Alternate Hypothesis: There is a mean difference of 15% in Serum Potassium levels between the     two groups.      Objective: To compare the efficacy EPR and IVPR for treatment of hypokalemia (measured as     change in serum potassium levels in milliequivalent/L after potassium replacement)   "
97123|NCT02014922|"     Dry eye is a very common condition that most often affects women and the elderly, and can be     caused when the eyes do not produce enough tears, or when the tears evaporate too quickly.     Although there isn't a simple cure for dry eye, there are numerous products on the market     that attempt to help relieve some of the discomfort caused by this condition. Some of these     products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications.     The purpose of this study is to evaluate the performance of a combination of TheraTears®     products, and to compare them with the product(s) you have been using.   "
97045|NCT02015949|"     Traumatic brain injury (TBI) is the most common cause of death and disability in young     adults. Patients can experience significant problems with concentration, attention, and     memory (so called 'cognitive impairments') following TBI. These cognitive impairments can     drastically impact on a patient's well-being, and can lead to significant economic and social     consequences. Roughly a quarter of TBI patients improve but an equal number deteriorate over     time. The investigators know little about why patients vary so much in how they recover.     Crucially, the investigators have no treatments to improve brain functioning or recovery     after TBI.      Trials investigating ways of protecting the brain just after injury have been disappointing.     An alternative strategy, however, is to improve the function of brain regions that remain     intact, but that function inefficiently after TBI. The investigators know that dopamine (a     chemical in the brain) is known to influence many brain functions and the investigators know     that pathways in the brain that use dopamine are affected by TBI.      In humans, drugs that increase dopamine in the brain, such as methylphenidate, are sometimes     used to enhance cognitive function after TBI, but the response to treatment can be highly     variable between patients. Therefore, what is needed in the clinic is a way to target the use     of these drugs to patients who are likely to respond.      In a single centre study, the investigators will use SPECT (Single Photon Emission     Tomography) imaging to measure dopamine levels in the brain. MRI (Magnetic Resonance Imaging)     scans will assess brain structure and function. The investigators will test whether treatment     with methylphenidate improves cognitive functions in TBI patients who have ongoing cognitive     problems, whether the mechanism involves a normalisation of brain functioning and whether     brain dopamine levels can predict the magnitude of any improvement in symptoms.   "
97046|NCT02015936|"     The purpose of this study is to understand if a home-based physical activity program can     improve symptoms and physical function among patients with advanced stage cancer.   "
97047|NCT02015923|"     Main outcome: Assess the impact of cancer-related survival at 2 years in patients with     unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery     followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and     mortality in patients treated with resection of the primary tumor. Assess complications and     meed for surgery in patients treated with systemic chemotherapy only during the course of the     disease. Identify and describe the complications related to chemotherapy and toxicity in the     short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30     and QLQ-CR29. To study prognostic survival factors.      Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to     evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV:     chemotherapy alone versus primary tumor resection plus chemotherapy.      Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical     resection of the primary tumor in stage IV colorectal patients with unresectable synchronous     metastases increases by 14% overall survival compared to patients receiving systemic     treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).   "
97048|NCT02015910|"     The primary objective of this study is to compare the rate of healing as well as percent of     wounds healed in Type II diabetic patients with chronic foot ulcerations receiving     sitagliptin versus placebo.      The hypothesis for this study is that subjects receiving daily doses of sitagliptin in     combination with their regular antihyperglycemic medications will result in increased healing     rates as well as a greater number of healed wounds as compared to subjects receiving placebo     and their regular antihyperglycemic medications.   "
97051|NCT02015871|"     This trial is an open-label, multi-centre, single arm extension for the 000006 trial in     Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day     intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous     (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients,     who received goserelin treatment in the main trial, will get a degarelix starting dose (240     mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this     2-year extension trial is to collect long-term safety and tolerability data for the one-month     dosing regimen.   "
97052|NCT02015858|"     Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the     measurement of skin conductance.      Withdrawal of chest tube can be painful and the purpose of the study was to compare     auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.   "
97053|NCT02015845|"     The objective of this study is to evaluate the effectiveness of Accuvein to facilitate     placement of peripheral intravenous catheters in obese patients. This clinical protocol is     designed to determine whether using Accuvein increases the ease and efficiency of venous     cannulation (as perceived by the operator), decreases the time to effective cannulation, and     decreases the patient's perception of the pain.   "
97054|NCT02015832|"     Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in     the functional assessment of patients with new coronary 3-vessel-disease who undergo     percutaneous coronary intervention (PCI)   "
97055|NCT02015819|"     This phase I trial studies the side effects and determines the best dose of genetically     modified neural stem cells and flucytosine when given together with leucovorin for treating     patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in     the brain. The neural stem cells that are being used in this study were genetically modified     express the enzyme cytosine deaminase (CD), which converts the prodrug flucytosine (5-FC)     into the chemotherapy agent 5-fluorouracil (5-FU). Leucovorin may help 5-FU kill more tumor     cells. The CD-expressing neural stem cells are administered directly into the brain. After     giving the neural stem cells a few days to spread out and migrate to tumor cells, research     participants take a 7 day course of oral 5-FC. (Depending on when a research participant     enters the study, s/he may also be given leucovorin to take with the 5-FC.) When the 5-FC     crosses into brain, the neural stem cells convert it into 5-FU, which diffuses out of the     neural stem cells to preferentially kill rapidly dividing tumor cells while minimizing     toxicity to healthy tissues. A Rickham catheter, placed at the time of surgery, will be used     to administer additional doses of NSCs every two weeks, followed each time by a 7 day course     of oral 5-FC (and possibly leucovorin). This neural stem cell-based anti-cancer strategy may     be an effective treatment for high-grade gliomas.      Funding Source - FDA OOPD   "
97056|NCT02015806|"     The aim of this study is to determine whether adherence to oral maintenance medications     differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox,     or none of these devices, with the hypothesis that low-touch devices improve adherence over     control and that the increase in adherence is agnostic across devices.   "
97057|NCT02015793|"     The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of     adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese     subjects with Crohn's disease.   "
97060|NCT02015754|"     Purpose:      The purpose of this study is to determine the feasibility and safety of using small beads     (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat     patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded     with irinotecan (DEBIRI-M1), and used to administer transarterichemoembolization (TACE).      Eligibility:      Patients with liver cancer from colorectal cancer.      Study Overview/ Treatment:      DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to     deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows     for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the     targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into     the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and     more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and     blood tests (to include assessment of liver function and tumor markers) and by imaging     (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will     be exited from the study and followed for survival. Once exited from the study they will     continue to be eligible to receive DEBIRI, should it be recommended.   "
97061|NCT02015741|"     The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic     parameters. Nowadays it can be evaluated by several monitoring methods, derived from     electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton,     USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical     Devices Inc., Cleveland, OH 44103, USA).      Use of such devices is discussed in aged patients. The purpose of this study is to compare     Bispectral Index and NeuroSENSE during awake periods and during natural sleep.   "
97062|NCT02015728|"     This research study is a Feasibility clinical trial. In this trial, researchers are trying to     figure out whether a medication can be chosen based on rapid testing done on tumor tissue.     Information from a feasibility or pilot trial will hopefully help researchers plan larger     trials in the future to determine the effect of this therapy.   "
97063|NCT02015715|"     This randomized, double-blind, placebo-controlled, single ascending dose study will assess     the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and     Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to     receive a single oral administration of RO6864018 or placebo. Total study duration for each     participant is up to 9 weeks.   "
97068|NCT02015650|"     Concomitant radio-chemotherapy has become a standard therapy for advanced squamous cell     carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis,     increase in combination with radiotherapy. Mucositis, as a painful inflammation and     ulceration of the oral mucosa, limits patient´s treatment plan. Studies showed that one third     of the patients discontinued Chemotherapy because of the side effects. Accordingly to these     side effects, patients eating habits get limited. This requires an increase of pain     medication, mostly an opioid derivate, which causes side effects too, which requires other     symptomatic medication. This requires a change of nutrition from hard to pappy food and at     further impairing, liquid food is needed. A central vein catheter has to be done for parental     nutrition and a gastrostomy for enteral nutrition, which means risk of haemorrhage and     increased risk of bacteraemias and sepsis for the patient. This would mean a decrease of     general condition and a dose reduction or treatment stop is needed. Accordingly, the results     are treatment delay and prolongation of hospital stay.      Risk of the study will be the known side effects of the products: Mitomycin-C,     5-Fluorouracile, Cetuximab and radiation therapy. These are listed in the particular product     description and the description of radiation thera-py. Another risk would be that the primary     objective cannot be fulfilled. So the patients would have a lower quality of life than     expected. Following benefits are expected.      Benefit for patient:        -  Decrease of mucositis and side effects caused by mucositis, also xerostomia, taste          disturbances, dietary restrictions, dysphagia        -  Decrease of pain medication and side effects caused by pain medication        -  Decrease of surgical intervention (gastric tube, central venous catheter) and risks          caused by the interventions (sepsis, bacteraemia, bleeding, injury of heart and stomach,          etc.)        -  Improving of patients social functioning, social eating, social contact        -  No interruptions of therapy        -  Increase of life quality        -  Weight stabilization      Benefit for clinical practice:        -  Increase of compliance        -  Fulfilling of complete therapy        -  Hospital stays as planned   "
97069|NCT02015637|"     The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin     versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated     cervical, urethral, rectal, or pharyngeal gonorrhea.   "
97070|NCT02015624|"     This register will evaluate the use of different antithrombotic therapies, combinations of     different drugs routinely used during any stage of hospital admission, with their timing,     dosage and mode of administration, in patients with a diagnosis of Acute Coronary Syndrome in     the Italian Coronary Care Unit during a study period of three weeks   "
97071|NCT02015611|"     The purpose of this study is to see if vitamin D supplementation improves muscle function.   "
97072|NCT02015598|"     Obstructive sleep apnoea syndrome (OSAS) is characterised by repeated episodes of upper     airway occlusion during sleep.It can cause cycles of hypoxia reoxygenation. And it was     postulated that intermittent hypoxia seems to resemble ischemia-reperfusion.Many study     suggest that ischemia-reperfusion represents an oxidative stress causing increased generation     of reactive oxygen species, especially superoxide anions.It is one of the most important     mechanisms of cardiovascular diseases, including hypertension, coronary artery disease and     cerebrovascular accident complication with OSAS.So many individuals approve OSAS is an     Oxidative Stress disease.      Continuous positive airway pressure (CPAP) is the first-line of treatment method in     moderate/severe OSA.But poor adherence to CPAP treatment is very common.The failure rate with     CPAP treatment is more than 50%.So we are searching a new treatment for that patients.     Carbocysteine is a antioxidant.It can not only scavenges the free radicals but also     replenishes glutathione(GSH)which is has double antioxidant capacity. However, Carbocysteine     is cheaper than other which has double antioxidant capacity drugs,such as     N-acetylcysteine.The purpose is to evaluate efficacy of oral intake of Antioxidant     Carbocysteine witch can reduce oxidative stress and improve the symptom of OSAS.It recover     the imbalance in the oxidant-anti-oxidant status may reduce cardiovascular abnormalities in     Patients with OSAS.   "
97124|NCT02014909|"     Part I will evaluate the pharmacokinetic profile and safety of KTN3379 over several doses     with the objective of defining a Phase 2 dose in patients with advanced malignancies. Part II     will evaluate the pharmacokinetic profile and safety of KTN3379 in combination with other     targeted agents and obtain preliminary evidence of anti tumor activity in specific types of     cancer. Patients will continue receiving KTN3379 alone or in combination until disease     progression or toxicity that necessitates discontinuation (whichever comes first).   "
97170|NCT02013323|"     The present clinical trial was designed to investigate the clinical and microbiological     effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and     root planing (SRP) in the treatment of chronic periodontitis (CP)   "
97073|NCT02015585|"     The edentulism and use of inadequate dentures, unstable and with teeth worn because long     period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of     occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa     relation. The reline of the denture base and the use of interocclusal appliance prior to     definitive rehabilitation could have influence on these functional aspects. However, there     are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two     treatments in reestablishing these functional aspects. The, aim of this study is to evaluate     whether the denture base reline and the use of interocclusal appliance prior to final     rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete     denture wearers. For this controlled, crossover, randomized and blinded clinical trial, 30     volunteers, totally edentulous, complete denture wearer over a period of five year, will be     selected. The volunteers will be randomly allocated into three subgroups (n= 10) and will     receive the following treatments: Control (C)Volunteers will receive new complete denture     without any previous intervention in their old complete denture; Relining Denture     (RD)Volunteers will be submitted to the relining of the base of the their old complete     denture and after 30 days of usage and before the replacement of the new complete denture, an     evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to     the treatment with interocclusal appliance and after 30 days of usage and before the     replacement of the new complete denture, an evaluation will be performed. Volunteers will be     evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi     arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical     dimension by Willis compass and photographic record. These evaluations will be performed at     three periods, T0 baseline; T1 after application of randomized treatment, reline denture and     interocclusal appliance); T3 after final rehabilitation. The control group will be evaluated     only at periods T0 and T3.   "
97074|NCT02015572|"     Low back pain (LBP) is a recognized public health problem with high life time prevalence.     Medical treatment may reduce the physical and mental discomfort, while it has not been able     to improve the possibilities for retaining or return patients with LBP to work.      This is an occupational intervention study for patients with LBP and physically demanding     work, who are at risk of drop out of labour; a randomized controlled trial designed to test     the effectiveness of an early intervention for retaining subjects with LBP attached to the     labour marked. A work place modification intervention combined with moderate physical     activity is given in the intervention group additional to LBP treatments according to best     practice recommendations for general practice.      The study population consists of patients in self-reported physically demanding, who are sick     listed or at risk of sick leave due to LBP. Outcome will continually be collected during the     intervention as well as 6 and additionally at 12 months follow up.      The primary aim is to evaluate if an occupational intervention with focus on early workplace     orientated counselling and work place intervention can retain subjects with physically     demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.      The secondary aims are to identify prognostic factors of an occupational intervention using     the baseline and follow-up participant-rated outcomes: pain, physically function, generic     health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with     intervention, clinical examination and MRI findings. Among these variables, we also aim to     identify subjects, who will benefit from such an occupational intervention, and the subjects,     who already have a good prognosis and therefore have no need for a larger scale intervention.   "
97075|NCT02015559|"     This randomized phase II trial studies how well mucoadhesive oral wound rinse works in     preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone     receptor (PR)-positive metastatic or locally recurrent breast cancer that cannot be removed     by surgery receiving everolimus. Mucoadhesive oral wound rinse may help prevent symptoms of     stomatitis, or mouth sores, in patients receiving everolimus.   "
97076|NCT02015546|"     This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10     mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from     generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S.     FDA for the treatment of major depressive disorder in adults. The purpose of this study is to     evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability     (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As     vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent     the recurrence of depression, for the purposes of this study it is considered     investigational. The word investigational means that the study drug is still being tested     in research studies and has not been approved for this use by the FDA.   "
97077|NCT02015533|"     The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the     drug) and immunogenicity (ability of a particular substance to provoke an immune response in     the human body) of CR8020 in japanese healthy participants   "
97078|NCT02015520|"     The primary purpose of this study is to identify an appropriate dose of study medication.   "
97079|NCT02015507|"     To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the     pharmacokinetics of VX-661 when administered in combination with ivacaftor   "
97080|NCT02015494|"     One dose of escalating strengths of an investigational influenza vaccine VAX2012Q     (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for     tolerability and immunogenicity in healthy adults 18-40 years of age.   "
97081|NCT02015481|"     The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous     Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.   "
97082|NCT02015468|"     A prospective, randomized study investigating the possible benefits of immediate mobilization     and frequent physiotherapy following a wrist fracture treated by volar plating.      The current study will test the following null hypothesis:      There is no significant difference between patients who receive a cast for the first 2 weeks     postoperatively and then instructions in home exercises and patients who receive a cast for     2-3 days postoperatively and then have frequent sessions with a physiotherapist following     volar locked plating for a extraarticular distal radius fracture, as evaluated by     self-reported satisfaction after 3 months.   "
97083|NCT02015455|"     The overall goal of the Lumbar Image Reporting with Epidemiology (LIRE) is to perform a     large, pragmatic, cluster randomized controlled trial to determine the effectiveness of a     simple, inexpensive and easy to deploy intervention - insertion of epidemiological benchmarks     into lumbar spine imaging reports - at reducing subsequent tests and treatments. The     investigator's main hypothesis is that for patients referred from primary care providers,     inserting epidemiological evidence in lumbar spine imaging reports will reduce subsequent     diagnostic and therapeutic interventions, including cross-sectional imaging (MR/CT), opioid     prescriptions, spinal injections and surgery.   "
97151|NCT02014558|"     The objective of this study is to assess the safety and tolerability, including the maximum     tolerated dose, of ASP2215 in subjects with relapsed or treatment-refractory acute myeloid     leukemia (AML). This study will also determine the pharmacokinetic (PK) parameters of     ASP2215.   "
97084|NCT02015442|"     AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men     with liver fat levels below 5%      DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4     week wash-out period. Dietary intervention will be based on iso-energetic substitution of     sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high     sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK     intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy     intake. Otherwise the macronutrient balance in both conditions will be based on UK average     habitual intake.      POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2, with     normal liver fat levels (<5%) and fasting plasma glucose and no evidence of insulin     resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal     disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of     subjects to range from sedentary to a maximum of meeting the UK minimum activity     recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2     units per day.      TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by     completion of a 7-day food diary and be asked to wear an accelerometer armband to assess     physical activity before each intervention week. Resting energy expenditure will also be     assessed by indirect calorimetry.      7 day dietary interventions: Participants will be resident at the clinical research facility     at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food     will be provided at the facility. At the weekends, participants will have to leave the unit     but food will be provided for those two days so that the diet can be continued at home.      At the start and end of each 7 day intervention: Weight, height and waist circumference will     be taken; percentage liver fat and total and regional body composition will be measured by     MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood     pressure.   "
97085|NCT02015429|"     The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to     together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response     to the meal compared to a meal without yellow pea components and reduce food intake at a meal     served 2 hours later.   "
97086|NCT02015416|"     This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical     safety and immune response of IDC-G305 when injected intramuscularly in patients with     unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant     NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's     immune system to fight the spread and growth of cancer for patients whose tumors include the     NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer     may be considered for the trial.   "
97087|NCT02015403|"     Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences)     emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care     Unit) in view of upper GI bleed randomized to two groups      GROUP A : 70 Patients will receive standard care + NAC infusion for 72 hours      GROUP B : 70 Patients will receive standard care only      NAC will be given at following rate :      Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then     continuous infusion of 6.25 mg/kg for the remaining 67 hrs   "
97175|NCT02013258|"     Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of     oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of     this study is to determine if oxytocin (OT) administration will improve some of the aspects     of Prader-Willi syndrome that are particularly troublesome for children and their families     (the insatiable appetite and social behaviors).      The research questions are:        1. Does intranasal oxytocin cause any side effects in children with PWS?        2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?   "
97836|NCT02005575|"     The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the     effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine     solutions on the duration of pain relief and post operative pulmonary function.   "
97088|NCT02015390|"     The United States Department of Defense (DoD) is funding exciting new research at the     University of Texas Medical Branch (UTMB) Department of Orthopaedic Surgery and     Rehabilitation that can be a major improvement in the treatment of extremity trauma involving     segmental bone loss. These devastating injuries occur frequently in both civilians and the     military. They typically result from motor vehicle accidents, high-energy fractures, gunshot     injuries, and blast injuries, but also from the surgical removal of a bone segment because of     infection or tumor. Despite many modern medical advances in this area, bone healing that can     adequately replace bone loss and restore pre-injury limb function is extremely difficult to     achieve. Existing standard treatment procedures are exceedingly complicated, require highly     specialized equipment and clinical skills, and usually require many surgical procedures over     many months or years. Despite these effort and costs, major complications usually occur with     all the standard treatment options, the patient's ability to return to an acceptable     functional status is typically low, and, therefore, many of these patients have their limbs     amputated.      The UTMB Department of Orthopaedic Surgery and Rehabilitation will conduct a DoD-funded     clinical trial to determine and compare the advantages of two new and innovative surgical     bone defect treatment techniques that can be significantly more effective for wounded     warriors or civilian patients and with these conditions. One treatment method, called the     Masquelet Technique, involves two-stage surgery: the first one to create a biomembrane     around the defect by applying a cement spacer, and then the second one for cement spacer     removal and defect bone grafting. The other method, developed by UTMB physicians, is the     Cage Technique and it comprises one-stage surgery in which a special hollow, fenestrated,     titanium cage filled with bone graft is implanted in the defect. Initial clinical experience     with both of these techniques has been very promising, but to date, there has been no     prospective clinical study comparing the two new methods of defect treatment. Identifying an     optimal surgical bone defect reconstructive technique would significantly improve the     clinical outcomes of patients with these challenging conditions.   "
97089|NCT02015377|"     The overall objective of FAME is to examine the metabolic and behavioral links between     dietary intake and its subsequent effects on circulating appetite regulating hormones and     physical activity levels in Hispanic and African American adolescents.   "
97099|NCT02015247|"     Pathogenesis of hip dysplasia Hip dysplasia is multifactorial in origin influenced by genetic     and intrauterine factors, such as mechanical (rump presentation and oligohydramnios) and     hormonal factors1. To ease the passage through the birth canal, the hip joint is quite mobile     perinatally. Postnatally, the laxity of the ligaments will subside and the femoral head will     normally position itself deeply in the acetabulum2. The theory is that if the femoral head     does not migrate sufficiently into the acetabulum, dysplasia may develop because the matrice     to stimulate acetabular growth is not correctly positioned. Normally, at birth the femoral     head sits deep in the acetabulum held by surface tension of the synovial liquid. The growth     and the hemispherical morphology of acetabulum are dependent on the presence of a normally     growing and correctly placed spherical femoral head that works as a convex matrice. If for     some reason the normal development is disturbed pre- or postnatally, pathologic relations may     develop between the femoral head and the acetabulum3, leading to hip dysplasia.      Purpose of this research project is to investigate if the correction of the acetabulum is     accurately performed when the surgeon use navigation equipment during PAO.   "
97152|NCT02014545|"     This is a randomized, double blind placebo controlled study to evaluate safety and efficacy     of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy     (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.   "
97090|NCT02015364|"     Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8     affects the functional outcome and patient reported outcome after treatment of acute Achilles     tendon rupture.      Type of study      Randomized, controlled trial (RCT). 130 patients will be included.      Time schedule      Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years      Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are     treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage     is changed to a removable orthosis and full weight bearing is allowed.      Patients who choose to participate in the trial will - through randomisation - be placed in     one of the two groups:        1. The intervention group: Must perform controlled mobilization-exercises from the          beginning of week 3.        2. The control group: In line with the current treatment regimen the patients must keep the          boot on at all times and they are not allowed to move the ankle.      Treatment protocol for the two groups is similar concerning orthose, removal of wedges and     weight-bearing. The only difference is that patients in the intervention group are instructed     to do ankle exercise.      Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12     months. The study's primary endpoint is at the 12 month mark.      Population Patients who are treated for acute Achilles tendon rupture at Copenhagen     University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to     participate are treated according the standard regimen (non-operatively without early     controlled movement of the ankle joint).      Number of patients 65 patients will be included in each group (a 130 patients in total).   "
97091|NCT02015351|"     Efficacy of monthly intravitreal anti-vascular endothelial growth factor (VEGF) associated to     systemic immunosuppression in patients with Vogt-Koyanagi-Harada Disease and choroidal     neovascularization. Minimum follow-up 12 months. Endpoints: 6 and 12 months of follow-up.     Outcome measures: improvement of VA, decrease in central foveal thickness as measured by     Optical Coherence Tomography (OCT) and absence of intra/subretinal fluid.   "
97092|NCT02015338|"     Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to     determine the brain area that controls hand function will not differ from TMS-guided     determination of individual motor hotspots. In children with hemiparesis, however, those two     locations will diverge. The prediction is that TMS will best guide tDCS interventions   "
97093|NCT02015325|"     The objective of the study is to evaluate the impact of the Planet Water Foundation's     intervention to improve Water, Sanitation and Hygiene related illness for reducing     absenteeism and diarrheal episodes among school children resulting in improvement of their     learning performance and ultimately long term economic prosperity.   "
97094|NCT02015312|"     Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid     light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest     posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.   "
97095|NCT02015299|"     Diabetes is associated with an increased risk for developing premature macrovascular     complications. The process of irreversible subclinical damage to the vasculature already     starts during its preceding stages. Dipeptidyl peptidase (DPP)-4 inhibitors have been shown     to attenuate vascular damage in preclinical studies. Off-target effects on adipose tissue     inflammation, liver steatosis and atherosclerotic plaques have been extensively documented in     animal studies.      Based on these considerations the investigators hypothesize that early therapy with the DPP4     inhibitor linagliptin in subjects with treatment naive type 2 diabetes will lead to     beneficial effects on arterial stiffness as measured by pulse wave velocity.   "
97096|NCT02015286|"     This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term     Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth     hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via     easypod™.   "
97097|NCT02015273|"     This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long     Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for     growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN®     via easypod™.   "
97176|NCT02013245|"     The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential     substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation     in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight     against the current world epidemics in tuberculosis and resistance to anti-TB drugs.   "
97546|NCT02009371|"     The purpose of this study is to investigate the efficacy and safety of light-emitting     diode(LED) light therapy on Chinese patients with Depressive Episodes of Bipolar Disorder and     to gather prime research data and application parameters of LED light source which is not     currently available in China.   "
97098|NCT02015260|"     Objective To assess the efficacy of the topical application of Nitric Oxide, delivered using     acidified nitrite.      Design Multicentre, randomized, controlled, dose ranging trial. A control arm and three doses     of acidified nitrite applied topically for 12 weeks with a further 12 weeks of follow up.      Setting The trial setting was in European genitourinary medicine clinics      Participants Male and female volunteers over 18 years of age with between 2 and 50     ano-genital warts, 328 were screened for eligibility and 299 subjects from 40 centres were     randomised.      Exclusions Pregnancy; concomitant Sexually Transmitted Disease; internal warts requiring     treatment other than surgery /laser; diabetes ; Human Immunodeficiency Virus-positive,     immunosuppressed and/or using immunosuppressive therapies; drug abuse.      interventions compared        -  Control Placebo nitrite cream and placebo citric acid cream twice daily        -  A) 3% sodium nitrite + 4.5% citric acid creams twice daily        -  B) 6% sodium nitrite + 9% citric acid creams once daily        -  C) 6% sodium nitrite + 9% citric acid creams twice daily      Outcomes        -  Primary proportion of patients with complete clearance of target warts Secondary        -  Time to clearance        -  Wart area        -  Wart count        -  Patient and investigator assessment of efficacy        -  Safety        -  Tolerability        -  Adherence   "
97100|NCT02015234|"     This was an open-label, extension trial designed to evaluate the long-term safety over 12     months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia.     Patients recruited into this trial were those who had successfully completed the double-blind     study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they     received during the double-blind study.   "
97103|NCT02015195|"     The purpose of the study is to attempt to determine which treatment from commonly used     treatments is the best at reducing pain and redness of the skin after a sting from a     Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.      Jellyfish stings are a common occurrence in many parts of the world causing significant     morbidity to persons stung by jellyfish while participating in marine activities whether     commercial or recreational. Much debate and confusion exist both in the medical literature     and the common recommendations regarding how to treat persons stung by jellyfish.     Specifically concerning what topical treatments are most efficacious at decreasing     envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst,     decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal     recommendations and past studies have referenced numerous different topical treatments for     jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits,     ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old     wine, salt water, cold packs, hot water, and commercial products such as Stingose and     Stingaid. Conflicting data exists regarding what works and what does not for nematocysts     discharge, skin erythema, and pain reaction.      The investigators would like to investigate which treatment is best out of some of the more     commonly studied treatments for reducing pain and erythema.      The investigators would like to complete a research study to try to bring some reasonable     evidence to the field treatment of jellyfish stings, namely, the decontamination process     (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).      The questions asked are as follows:        -  What topical treatments for jellyfish stings actually decrease the amount of          inflammation seen on a macroscopic level on the skin of humans?        -  What topical treatments for jellyfish stings actually decrease the sensation of pain in          humans?        -  Do topical chemical treatments cause different outcomes when exposed to the above          parameters?        -  Do different species of jellyfish nematocysts react differently based on the type of          topical chemical treatment used? What is the variation of effects of topical treatments          based on the species of jellyfish sting?      Specifically, the investigators will be stinging human subject on both arms with a segment of     tentacle for approximately 2 minutes. This will be followed by no treatment on one arm     (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium     bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%),     isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will     include pain and erythema.   "
97104|NCT02015182|"     The aims of this study are to determine population PK parameters of bupivacaine in children     following TAP block using a population-based PK approach, and to evaluate the influence of     patient covariates on drug disposition.   "
97105|NCT02015169|"     We planned this study to investigate the efficacy and safety of XELOX (capecitabine and     oxaliplatin) plus lapatinib treatment in HER2-positive gastric cancer patients with liver     metastasis.   "
97106|NCT02015156|"     This study is to prove that there is no difference in the number of healthy male volunteers     that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24     hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab     sourced from the United States (trastuzumab-US). The study will also compare the safety of     both drugs.   "
97107|NCT02015143|"     The purpose of this study was to investigate the reliability and validity of the bipolar     index (BPX) to diagnosis bipolar disorder, and to verify the stability of it in identifying     bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar     disorder in natural status.   "
97177|NCT02013232|"     Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents     and atypical antipsychotics such as risperidone. Recent studies have suggested that     aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics.     Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with     aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with     risperidone.   "
97108|NCT02015130|"     The prevalence of Type 2 diabetes (T2D) is rising rapidly worldwide. In Denmark approximately     8% of adults have T2D and more than 25.000 are diagnosed each year. This has vast     consequences for society and the patient.      Standardized treatment aiming at normalizing blood glucose and hypertension comparable to     healthy individuals, have been tested in large studies. The effect on cardiovascular disease     and other complications have been modest at best and one study showed an increased mortality     with intensive treatment. The standardized treatment often results in polypharmacy, which     increases the risk of patients discontinuing treatment.      We propose a new approach to treatment of T2D, where the patients' individual characteristics     are considered. The aetiology of the diabetes can be different, which warrants different     treatment. Many patients have concomitant illness which can affect the way the patient is     treated. A tight regulation of blood glucose can in some patient constitute a risk of adverse     effects, especially hypoglycemia. In that sense individual targets for the treatment are     important. Effective lifestyle treatment has importance for a successful outcome and we     therefore offer an application that can help the patient and the physician organizing     activity individually.      The objective of individual treatment is to choose the most effective medication. If a     prescribed drug does not have the desired effect it should be replaced with a different drug.     The overall goal is to reduce the number of substances and side-effects, but simultaneous     improve treatment and reduce the incidence of cardiovascular and other diabetes-related     complications. This will in turn result in improved quality of life and improved adherence to     treatment.      The potential effect of individual tailored treatment of T2D is to improve the guidelines of     treatment, not only to improve the patients' health, but also to reduce the socioeconomic     consequences of the growing T2D prevalence   "
97109|NCT02015117|"     This phase I trial studies the side effects and best dose of trametinib with or without whole     brain radiation therapy in treating patients with brain metastases. Trametinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs, such as     trametinib, may make tumor cells more sensitive to radiation therapy. Giving trametinib with     whole brain radiation therapy may be a better treatment for brain metastases.   "
97110|NCT02015104|"     Background:      - Many cancers produce two particular proteins. The immune system can target these to attack     the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the     body sees the proteins as foreign invaders and attacks them. Researchers will test PANVAC on     people with high grade non-muscle invasive bladder cancer. They will give it to people who     have not responded to the usual treatment, bacillus Calmette-Guerin (BCG) over several weeks.     They want to see if PANVAC plus BCG is better than BCG alone.      Objective:      - To compare the effects of PANVAC plus BCG therapy, to BCG therapy alone.      Eligibility:      - Adults 18 and older with high grade non-muscle invasive bladder cancer who failed at least     1 course of BCG.      Design:        -  Participants will be screened with blood and urine tests and abdominal scans.        -  Participants will be randomly assigned to get BCG only or BCG plus PANVAC.        -  They will have up to 10 visits over 15 weeks. Most of these are part of usual cancer          care.        -  They will have blood and urine tests.        -  All participants will get BCG in 6 weekly injections.        -  One group will also get PANVAC in 5 injections over 15 weeks.        -  Between weeks 17 and 20, participants will undergo tests of the tumor area as part of          their usual care. They will have cystoscopy, exam under anesthesia, and bladder biopsy.          Results will be used to evaluate the different treatments.        -  Participants will have quarterly follow-up visits for up to 2 years.   "
97153|NCT02014532|"     The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and     root planing in patients with chronic periodontitis leads to host inflammatory response     modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open     new vistas in treatment of chronic periodontitis.   "
97111|NCT02015091|"     Background:      - People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease     if later exposed to normal malaria parasites. Scientists have discovered how to make the     weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if     people who receive the vaccine get malaria after being bitten in a controlled setting (a     controlled human malaria infection, CHMI).      Objective:      - To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting.      Eligibility:      - Healthy adults 18 45 years old.      Design:        -  Participants will be screened with medical history, physical exam, blood and lab tests,          and EKG.        -  Participants will be split into 8 groups, to be in the study for 3 12 months.        -  Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or          muscle.        -  Participants will keep a health diary and be contacted by phone.        -  For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5          minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be          exposed to malaria more than once.        -  After CHMI, participants will visit the clinic very frequently (including daily visits          for 12 days) for 28 days.        -  Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical          history may also be repeated        -  Participants who develop malaria will be treated immediately at the clinic. Standard          treatment takes 72 hours. Malaria symptoms may last up to 3 days.   "
97112|NCT02015078|"     Despite broad awareness of the role that diet plays in increasing obesity risk, adherence to     public health recommendations for maintaining healthy eating is low. Insights gained from     weight loss intervention trials find that trial participants report difficulty in restricting     calories, dissatisfaction with the pace of weight loss, inability to control eating, low     palatability of recommended foods and strong food cravings. Indeed, recent systematic reviews     provide empirical support that these subjective experiences that trial participants describe     likely represent eating-related traits or phenotypes . While amassing evidence supports     individual variation in these eating-related traits, to date there has been no systematic     effort to characterize robust eating-related phenotypes. Proposed is a Sub-study initially     planned to be piggy-backed on a planned Study being conducted by investigators at the     University of North Carolina (UNC-- Linnan, Dilworth- Anderson & Evans). The UNC Parent Study     was a feasibility study using community-based participatory research (CBPR) approaches to     explore possible intervention strategies aimed to reduce the burden of chronic disease and     cancer among African American families. The NHGRI-led eating behavior Sub-study is proposed     to be integrated with the UNC Parent Study (hereafter referred to as Phase 1). The additional     aims of the Sub-study (hereafter referred to as Phase 2) are to gain understanding of whether     we can characterize clusters of eating-related behaviors that may be associated with     adherence to weight management and weight outcomes. This current protocol lays out the     specific qualitative activities planned for Phase 1 which include conducting structured     interviews with Black Family Reunion organizers (N=8) and a sample of reunion participants     (N=40). We also describe the larger quantitative survey proposed for Phase 2. Pending the     feasibility of the sub-study with the African-American community, we will collect information     on eating-related behaviors in a large sample of individuals (N=350). If the initial     assessments (Phase1) prove that this is not a viable study to be conducted in that setting,     we will consider other population groups and other settings.      We are also considering Phase 3 activities if we identify clusters of eating-related     phenotypes within individuals. Amended IRB applications will be submitted prior to launching     Phase 3.   "
97187|NCT02014285|"     Examination of serial muscle ultrasounds and muscle sampling within the population of ICU     patients who require mechanical ventilation for acute respiratory failure, will lead to the     ability of investigators to link specific baseline comorbidities, drugs, or fluid     administrations, to the onset and duration of architectural changes within muscle and     correlate ultimately with muscle function. With this study, we will be better able to     understand the relationships between the pattern of resolution of the muscle architectural     abnormalities within the context of multiple other clinical abnormalities and therapies     present and rendered to ICU patients.   "
97113|NCT02015065|"     Background:      -Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in     one of their proteins called SDH. Vandetanib is a cancer drug that has been approved to treat     thyroid cancer and has been used with some success in other tumors that have a similar loss     of SDH. Researchers want to see if this drug can also decrease tumor growth in people with     WT-GIST.      Objectives:      -To test whether the study drug will benefit people with WT-GIST.      Eligibility:      -Adults and children 3 years old and older with WT-GIST.      Design:        -  Researchers will test participants tumor tissue to confirm it is the wild type of GIST.        -  Participants will be screened with a medical history, physical exam, and blood tests.          They will also have electrical recording of the heart (ECOG) and scans of the tumor.        -  Participants will take the study drug in 28-day cycles. Their doctor will decide how          many cycles they can complete.             -  They will take the study drug once every day and record it in a diary.             -  On Day 14, they will also visit their doctor to look for side effects.        -  Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood          pressure check, and blood tests. These tests will then be done periodically for as long          as they are in the study.        -  Before cycle 4, scans will be done to check the size of the cancer. Most of these will          be repeated every 3-6 cycles.        -  When they stop taking the study drug, participants will return to the clinic for a          physicial exam and blood tests.   "
97114|NCT02015039|"     Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of     botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of     rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with     a specific type of occupational therapy will be better than BoNT alone for treating these     patients. Additionally, studies on WC were hampered by the lack of objective, validated     rating scales. In this pilot study, we will assess the value of a new scale compared with     older scales.      Study population: The study population will consist of 12 WC patients (accrual ceiling of     16).      Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6     patients will receive BoNT therapy plus occupational therapy. The physical therapy will     involve specific exercises of finger movements in the direction opposite to the patient s own     dystonic movements, during the writing task. The movements will be isometric against splints     made to suit the individual patient. The final outcome will be assessed after 20 weeks of     treatment. Patients will be evaluated on several scales, including the writer s cramp rating     scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The     primary outcome will be based on patient reported subjective scale and the secondary outcomes     will be assessed by four blinded raters of the videotapes, done both before and after     treatment.      Outcome measures: The primary outcome is to show additional improvement from baseline with     BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a     patient-rated subjective scale. The secondary outcomes are to show improvement in scores of     WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program.     Additionally, the scores obtained from WCRS and WCIS will be compared.   "
97115|NCT02015026|"     Background:        -  Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per million          people per year. It has a very poor prognosis with an overall 5-year mortality rate of          75 - 90% and an average survival from the time of diagnosis of 14.5 months.        -  The treatment of choice for a localized primary or recurrent tumor is surgical          resection.      Patients with recurrent or metastatic disease are infrequently curable by surgery alone.        -  As with most solid tumors, chemotherapy options have limited benefit, although          platinumbased therapies have response rates of 25 to 30%. To date no targeted therapy          has been shown to be of any value in this disease.        -  The natural history of ACC can vary greatly with some patients surviving only months          while others can live with disease for years. The basis for these differing clinical          presentations is not known. While one cannot exclude an immune or other host component          as responsible for the diverse clinical courses, it is also possible that there may be a          genetic basis for this phenomenon. A bio-specimen repository will be a major step          towards more comprehensive studies of this very rare and unusual tumor, and allow us to          begin to characterize subgroups within the disease.        -  Patients with rare tumors seek expert advice in the management of their care. Dr. Fojo          has such expertise and is frequently asked to consult in the care of ACC patients          throughout the world. A natural history study would establish a more formal mechanism          for such referrals, while allowing the systematic collection of epidemiologic data as          well as much needed tumor samples.      Objective:      -To characterize the natural history of adrenocortical cancer, and in the process, collect     blood, and tissue samples to study genetic/biochemical pathways involved in the development     and progression of adrenocortical cancer (ACC).      Eligibility:        -  Patients greater than or equal to 12 years of age with biopsy-proven ACC        -  Patients greater than or equal to 12 years of age suspected of having ACC      Design/Schema:        -  Patients will be offered clinical consultation with treatment recommendations, including          standard of care and clinical trial options. Computed tomography scans of the thorax,          abdomen and pelvis will be performed for staging purposes as indicated; occasionally,          magnetic resonance imaging will be performed for the visualization of lesions in the          liver, spine, or other anatomic sites.        -  Medical histories will be documented and patients followed throughout the course of          their illnesses, with particular attention to patterns of disease recurrence and          progression, response to therapies, duration of responses and hormone production in          patients with hormone production as a manifestation of their disease. Tumor growth rates          will also be calculated throughout the course of the disease.        -  Blood and tumor samples will be obtained at baseline and at follow-up intervals when          surgery is indicated. Tumor samples may include samples harvested at other facilities          during or prior to enrollment on this trial.        -  Genetic and epigenetic analysis of tumors and in selected cases expression array          analysis will be performed.   "
97154|NCT02014519|"     The purpose of this study is to perform a epidemiological survey of the adult population in     Hungary to calculate the seroprevalence of pertussis.   "
97155|NCT02014506|"     Purpose of study: This phase I/II trial is to evaluate the safety and feasibility of     TCRαβ-depleted graft from haploidentical family donors in treating children and adolescents     with malignant or non-malignant diseases.   "
97116|NCT02015013|"     Idiopathic CD4 lymphocytopenia (ICL) is a rare syndrome defined by consistently low CD4 T     cell counts (<300/mm3) without evidence of HIV infection or other known immunodeficiency.     Patients with ICL are at risk for opportunistic infections typically associated with HIV/AIDS     such as disseminated cryptococcal infection and severe human papillomavirus-related     dysplasia. More than 20 years since the description of ICL, its etiology, pathogenesis, and     management remain unclear. In this study we propose to administer the combination of     granulocyte colony stimulating factor (G-CSF) and plerixafor to ICL patients and healthy     volunteers with the objective of harvesting mobilized CD34+ hematopoietic progenitor cells     (HPCs) by apheresis for transfer into immunocompromised mice and for study with in vitro     assays. The mice studies would serve to investigate thymic development, survival, and     trafficking of the mobilized human cells within murine lymphoid and non-lymphoid organs.      HPCs are used for various therapies and there is an increasing use of agents that stimulate     the bone marrow to produce progenitor cells and move them into the bloodstream where they may     be harvested by apheresis. Not all patients respond to GCSF with vigorous HPC mobilization.     The binding of chemokine receptor CXCR4 to stromal cell derived factor (SDF-1 or CXCL12) is     an important interaction between a hematopoietic progenitor cell and its marrow environment.     Plerixafor is a CXCR4 inhibitor which blocks binding to SDF-1 resulting in the release of     hematopoietic progenitor cells (CD34+) into peripheral circulation. In pharmacodynamic     studies of plerixafor in conjunction with G-CSF compared to G-CSF and placebo, a two-fold     increase in CD34+ cell count was observed.      Due to the important role CXCR4 plays in immune cell trafficking and its potential role in     the pathogenesis of ICL, we propose as a secondary objective to assess peripheral CD4 T cell     and CD34+ hematopoietic progenitor cell numbers and functions in ICL patients compared to     controls following G-CSF and plerixafor administration.      Study participants will be screened within 12 weeks prior to the study period. Eligible     participants will receive G-CSF for 5 days with hospitalization on Day 4 for plerixafor     injection followed by apheresis on Day 5. Participants will return for examinations and blood     draws on Days 8 and 12.   "
97117|NCT02015000|"     The treatment of pterygium is still quite controversial. Previous studies using a large     incision for pterygium excision and a large graft and has reported a very low recurrence rate     with the P.E.R.F.E.C.T. technique. However, the P.E.R.F.E.C.T. technique is a relatively     lengthy procedure and may not be suitable for patient with limited conjunctival reserve.     Thus, we try to evaluate the final outcome of a sutureless amniotic membrane transplant     technique combining the extended pterygium excision in hope to avoid the complication of the     P.E.R.F.E.C.T. for PTERYGIUM technique.   "
97118|NCT02014987|"     About 31% of the Danish population participates regularly in running. The positive health     benefits of running have been well documented in the literature. Unfortunately, running has     been connected with a high risk of injuries.      Running related injuries can cause a long rehabilitation and may even force the runner to     quit running permanently. To ensure that running can be practiced as a safe exercise activity     prevention must be considered.   "
97119|NCT02014974|"     Background: Worldwide injuries from trauma accidents represents a major population problem.     The World Health Organization (WHO) has deemed this problem as one of the most important     global priorities, calling 2011-2021 the Global Road Traffic Safety Decade. Despite this,     there is little empirical data in low and middle-income countries quantifying the burden of     fractures and the current practice of care.      Methods: We conducted a multicenter, prospective observational study of patients sustaining     fractures or dislocations who presented to an orthopaedic fracture unit at 14 hospitals in     India. A representative sample of patients were recruited during an 8-week period starting on     October 1, 2012. Patients were followed up to 30-days in hospital or until discharge to     determine if they suffered any outcomes. Primary outcomes included total mortality,     reoperation, and infection.   "
97120|NCT02014961|"     Quest for modifier genes associated with ventricular arrhythmias in presence of a cardiac     sodium channel gene (SCN5A-delPhe1617) mutation.   "
97188|NCT02014272|"     This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual     reference drugs in healthy volunteers.   "
97189|NCT02014259|"     This trial is conducted in Europe. The aim of the trial is to investigate the     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of     oral semaglutide in subjects with various degrees of impaired renal function compared to     subjects with normal renal function.   "
97121|NCT02014948|"     The lumbar spine is currently one of the most affected areas by nociceptive processes ,     referred back pain, which can be provided from a herniated intervertebral disc . Such     conditions are considered a public health problem , since considerably affect the population     , mainly young adults , which may lead to functional disability and absenteeism . Soon , his     treatment involves high costs and rehabilitation time indefinite , generating great     scientific interest focused on the search for new techniques that can provide an acceleration     of functional recovery of these individuals .      Thus , the establishment of evaluation protocols that provide quantitative data concerning     the functional capacity is of utmost importance . From the electromyographic analysis , one     can measure the electrical activity of muscle and identify abnormal patterns of response. For     the identification of kinematic changes becomes useful equipment capable of recording the     speed and angle of movement, as the accelerometer . Another evaluation method applicable to     cases of herniated disc and back pain is the force platform to quantify the ground reaction     force during the stance phase of the movement . Also , the quality of life should be taken     into account as routinely observed psychological impairment involving issues related to     vitality, emotional and social aspects , which can be identified through the questionnaire of     quality of life ( SF -36 ) .      With regard to physical therapy intervention , we seek to use resources to compose promising     treatment program along with conventionalexercises. A novel therapy in the treatment of back     pain is the whole body vibration , as it promotes increased range of muscle spindles via     increasing the tonic vibration reflex and consequently improving the mechanism of involuntary     muscle control . Thus , the association between an accurate assessment , exercises and     therapy vibratory seeks early rehabilitate individuals affected by back pain or herniated     disc , delaying or even avoiding surgery .   "
97122|NCT02014935|"     The poor eating habits and sedentary lifestyle of young people can reflect on structural     changes in adult life, leading to vascular brain diseases. The cerebrovascular accident (AVC)     represents the second cause of death throughout the country. Presents rapid development of     clinical signs, providing focal disorders or brain function. It is necessary to the knowledge     and development of new treatment techniques that may minimize the sequelae caused by the AVC,     which is a common disease and of great impact on public health, represents the main cause of     adult neurological disability, affecting the basic functions of the limbs, motor control and     balance, strength and mobility, which involves changes in daily life and low self-esteemIn     addition to the high cost of treatment and in the long run.      Thus, this study aims to analyze the response of low intensity laser on the prevention of     pain and fatigue induced in rectus femoris, vastus of patients with sequelae of spasticity     associated with effects on the laser promotes on muscle performance and muscle activity.      It is believed that this study get positive results as regards the increase of time     antecedent to muscular fatigue associated with the skeletal muscle performance, so that the     normotonics muscles gain strength and overcome the resistance of hypertonic muscles. In this     way, it is expected that after the application of low intensity Laser Therapy (LILT) occurs     to the adequacy of spasticity, muscle function the gain that had provided the highest quality     of physiotherapy care.      It is known that treatment with the laser on the skeletal musculature, presents positive     results and on the peak torque, by means of the skeletal muscle performance and consequently     gain increase muscle performance (LEAL JUNIOR et al, 2010; ALMEIDA et al, 2011).      Armed with this information you can infer that the low intensity laser therapy on the spastic     muscle, would result in improving muscle performance, with an increase of pre-stressing,     improving the functional capacity of individuals under the exercises imposed by physical     therapy. In this way, the sessions will take more satisfactory results which jointly provided     better quality of life for these patients.   "
97125|NCT02014896|"     The proposed study will validate the clinical use of new biomarker blood tests to identify     blood components that may differentiate between diverse stroke etiologies and clinical     outcomes as listed below:        1. Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes,          when hemorrhagic stroke is ruled out.        2. In cases of ischemic strokes of unknown or cryptogenic etiology, determine the ability          of biomarker blood tests to predict etiology between cardioembolic and large artery          atherosclerotic.        3. In cases of cardioembolic ischemic stroke, further differentiation of cardioembolic          ischemic strokes into those caused by atrial fibrillation (AF) and those not caused by          AF.        4. Differentiate transient ischemic attacks (TIAs) from acute ischemic strokes.        5. Differentiate TIAs from non-ischemic transient neurological events (TNE) with similar          symptoms.   "
97126|NCT02014883|"     The purpose of this project is to study the efficacy of triheptanoin oil in patients with     GLUT1 deficiency syndrome.   "
97127|NCT02014870|"     The primary objective is to determine the dose level of live, wild-type A/California/ H1N1     2009 virus that has an appropriate safety and illness/infectivity profile to be used as an     influenza virus, challenge strain in future intervention studies.      Illness parameters were collected by subject symptom scores as well as by physical     examination. Virus parameters were measured by PCR and cell culture assay (performed by     VisMederi srl).   "
97128|NCT02014857|"     Increased levels of cytokines in GCF have been demonstrated in smoker subjects with chronic     periodontitis. It is not surprising that increased levels of inflammation associated     molecules in GCF has been observed in smokers with periodontitis. However, it is not clear if     smoking has an influence on these parameters in periodontally healthy individuals. In the     present study, it has been hypothesized that smoking might affect the levels of GCF MMPs and     growth factors in young adults with periodontal health.   "
97129|NCT02014844|"     This is a pilot study to determine the efficacy and safety of aldoxorubicin in subjects with     glioblastoma who have progressed following surgery and prior treatments.   "
97130|NCT02014831|"     The purpose of this study is to evaluate the efficacy and safety of Cetuximab in metastatic     penile carcinoma   "
97134|NCT02014779|"     Objectives: This study will evaluate the efficacy of internet-based relapse prevention with     therapist support, as compared to face-to-face therapy at an employee assistance program. The     design is a two-armed randomized controlled design, and outcomes are measured in terms of     changes in problematic alcohol use, as well as depression and quality of life.      Method: Participants with problematic alcohol use who, after an initial evaluation consisting     of five face-to-face sessions with a licensed psychologist where alcohol and collateral     problems are extensively assessed, are recommended treatment for problematic alcohol use.     Consenting participants will be randomized into one of two groups: 1. Internet delivered     relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol     use, depression and quality of life as well as information on user satisfaction will be     gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.      Our hypothesis is that the internet-based program with therapist support and the face-to-face     therapy will be equally effective in reducing alcohol use (non-inferiority).   "
97135|NCT02014766|"     We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide     similar analgesia after shoulder surgery.   "
97136|NCT02014753|"     To treat patients with acute myocardial infarction, primary percutaneous coronary     intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium     stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard     drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated     by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent     placement, along with observation of changes over time in the target vessel. The     relationships between OCT findings and the time course of platelet aggregation and between     OCT findings and the occurrence of major cardio- cerebrovascular events will also be     elucidated.   "
97137|NCT02014740|"     The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®),     on the fat surrounding the heart.Excessive amount of the fat around the heart is common in     people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an     injectable prescription medicine that can improve blood sugar control in adults with type 2     diabetes.   "
97138|NCT02014727|"     The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 µg     dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel® in healthy European adults     not previously exposed to the parasite P.falciparum and in healthy African adults exposed to     the parasite. The safety and the tolerability of the vaccine will be assessed on the rate of     solicited and unsolicited events/reactions. The safety profile will include local and     systemic reactions/events as well as the biological safety, based on a clinically significant     change of the baseline value of the main biological criteria.   "
97139|NCT02014714|"     Obstructive Sleep Apnea (OSA) is a common clinical problem with a reported prevalence of 2%     to 4% in the general population. The incidence was double on patients who had a diagnosis of     OSA going for orthopedics surgery.      Little literature composed mostly of case reports or small retrospective case-control studies     exist examining the use of intrathecal opioids on outcomes in OSA patients is inconclusive.     The primary objective of this study is to compare the post operative respiratory effect after     single dose intrathecal morphine and intrathecal fentanyl on orthopedics patients who     suspected or undiagnosed obstructive sleep apnea.      Hypotheses      Undiagnosed OSA patients who received intrathecal morphine are more likely to have     respiratory events post-operatively.   "
97140|NCT02014701|"     The goal of this study will be to assess the incremental benefit of myocardial contrast     echocardiography for the assessment of regional wall motion abnormalities and infarct-related     artery in patients presenting with their first NSTEMI.   "
97141|NCT02014688|"     This study is being initiated to create a normal database including measures of optic nerve     head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg     Spectralis OCT device.   "
97142|NCT02014675|"     This registry is designed to gather further evidence, in addition to the SD01 Master Study,     for the safety and efficacy of the SD01 ICD lead.   "
97143|NCT02014662|"     An isolated bout of unaccustomed maximal eccentric exercise is associated with muscle force     loss for 2-4 days, mild reversible muscle tenderness, and ultra-structural damage to the     muscle fibers, elevation of muscle proteins in serum, and a detriment in range of motion.     This single center, pilot study is designed to optimize conditions for the robust measurement     of functional deficits after muscle damage and to identify markers of repair over 22 days to     inform future intervention studies. The primary measure will be limb force (assessed     electronically from the ergometer), previous studies have demonstrated that functional     measures return fairly rapidly, usually between 2-4 days. Additionally, several biomarkers of     muscle function will be measured over 22 days, as well as changes in protein synthesis in     biopsy samples Deuterium-labelled water (D2O) will be consumed by all study participants from     Day-3 through Day 22 to aid in quantifying newly synthesized proteins.   "
97144|NCT02014649|"     This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data     of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also     explore virology and efficacy endpoints.   "
97145|NCT02014636|"     This is an open-label, 2 part study of pazopanib and/or MK 3475 in treatment naïve subjects     with advanced RCC. Part 1 consists of a Phase I dose escalation of pazopanib + MK 3475     followed by an expansion cohort to determine the maximum tolerated regimen and the     recommended Phase II dose. Part 2 is a randomized 3-arm Phase II study to evaluate the     clinical efficacy and safety of pazopanib + MK 3475 as compared to single-agent pazopanib and     single-agent MK 3475. The objectives of this Phase I/II study are to test the safety and     tolerability of pazopanib in combination with MK 3475, and study the clinical efficacy of     pazopanib in combination with MK 3475 in subjects with advanced RCC as compared with     single-agent pazopanib and single-agent MK 3475.      Following the Urgent Safety Measure (USM) released on February 09, 2017, the phase II (Part     2) portion of this study will not commence.   "
97202|NCT02014090|"     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by     percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External     Counterpulsation (EECP) with regard to coronary collateral growth.   "
97146|NCT02014623|"     Allergic diseases represent a major health issue worldwide and epidemiological studies in     Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy     (genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay     treatment of allergic rhinitis is allergen avoidance and pharmacotherapy for symptom relief.     Allergen immunotherapy offers the advantages of specific treatment with long lasting     efficacy, and can modify the course of disease. However, use of this treatment is restricted     by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes     of allergen administration than the current conventional subcutaneous route (SCIT) have been     investigated including the sublingual route (SLIT) and recently sublingual tablets for pollen     allergy immunotherapy became available. The tablets are safe and easy to use and contain     pollen extracts from 5 of the most common allergy-causing European grasses but include     ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and     south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not     fully understood. The investigators propose conducting a longitudinal open label study to     investigate the immunological changes that occur with the 5 grass pollen sublingual     immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects.     The investigators will investigate the induction of relevant T cell regulatory immune     mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4.     Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will     be examined. This project will provide important fundamental knowledge on which to inform     decisions for the greater application of this treatment for subjects with moderate and severe     allergic rhinitis.   "
97147|NCT02014610|"     The complete blood count is a commonly performed blood test, and previous small studies have     suggested that the counts of some types of white blood cell in the complete blood count may     be related to the onset of cardiovascular diseases such as stroke and heart attack. This is     of interest because this information may help to predict strokes or heart attacks and may     guide new therapies which act on white blood cells to reduce the risk of cardiovascular     disease.      The hypothesis is that counts of particular types of white blood cell are associated with a     range of cardiovascular diseases.   "
97148|NCT02014597|"     The purpose of this study is to determine if an optokinetic contrast detection device is     sufficient to measure contrast sensitivity and to distinguish between patients with and     without glaucoma.   "
97149|NCT02014584|"     Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase     inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction     and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled,     parallel-group study to assess the impact of dutasteride treatment on sexual function as well     as subject satisfaction with hair growth and quality of life in men with AGA. This study will     consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks,     and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of     double-blind, placebo controlled treatment and 24 weeks of open-label treatment with     dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a     change in erectile function at the end of treatment.   "
97150|NCT02014571|"     GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment     of chronic hepatitis C virus (HCV) infection. The purpose of this study is to investigate the     effects of GSK2878175, at different doses in men and women infected with chronic hepatitis C     virus. The study will investigate how much of the drug gets into the blood stream and how     long the body takes to get rid of it. The study will also investigate if GSK2878175 has any     important side effects. The study will also measure what effect GSK2878175 has on the     hepatitis C virus infection after taking the study medication for 2 days. Approximately 44     people will take part in this study. Depending on the type of chronic hepatitis C infection a     subject will be enrolled into 1 of 4 groups randomly. Each group will participate in one     dosing session. One dosing session consists of GSK2878175 or a placebo (sugar pill) given     once per day for 2 days.      Group A, B, and C is made up of 8 participants per group. In each of these groups 6     participants will receive GSK2878175 and 2 participants will receive placebo. Group D is made     up of 20 participants. 15 participants will receive GSK2878175 and 5 participants will     receive placebo. The treatment groups will be dosed in sequence. Group A will be the first to     take the study medication, then Group B, and so on. The plan is to dose subjects in Group A     with 10 mg, Group B with 30 mg, Group C with 60 mg, and Group D with 60 mg of GSK2878175 or     placebo. The next treatment group's actual dose will be decided after looking at the results     from the previous group. The doses may therefore be higher or lower than planned depending on     the previous group's results. The number of participants enrolled in the next group may also     change depending on the results from the previous group.   "
97264|NCT02013076|"     The aim of the prospective cohort study is to: (1) document the magnitude of response to oral     corticosteroids administered to children presenting to the emergency department with moderate     or severe asthma and (2) quantify clinically available potential determinants of the response     to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental     tobacco smoke (ETS), gene polymorphisms, and their interactions.   "
97156|NCT02014493|"     Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature     respiratory center and having respiratory distress. CPAP requires intensive care monitoring     and special qualified staff. Continuous positive pressure makes a constant noise around the     child and can lead to an uncomfortable environment.The fixture of the binasal prongs can     cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered     important for the child.      Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive     care units.HFNC is considered to be easy to apply and a more comfortable respiratory support     for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified     air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from     intensive respiratory support, to prevent respiratory distress and as a respiratory support     after extubation.      There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is     to investigate the preterm infants respiratory effort by measuring electrical activity in     diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a     scoring system inspired by Silverman- Andersen retraction score. It is expected that measured     electrical activity in the diaphragm, measured respiratory parameters combined with bedside     observations provide applicable knowledge about preterm infants respiratory effort in     transition from CPAP to HFNC.   "
97157|NCT02014480|"     This is a multicenter, randomized, double-blind, 3-way crossover study to evaluate the lung     function response to UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.525 mcg, administered     once-daily via a novel dry powder inhaler (NDPI) over 14 days in subjects with COPD.      The study consisted of Run in Phase (5 to 7 days), Treatment Phase (made up of 3 treatment     periods of 14 days each separated by 10 to 14 days Washout Period) and Follow-up Phase (7 to     9 days after completion of final visit or premature discontinuation). Eligible subjects will     be randomized to a sequence of UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.5/25 mcg such that     all subjects will receive each treatment.      Serial spirometry assessments will be conducted on Day 1 and Day 14 and trough spirometry     will be conducted on Day 2 and Day 15 of each treatment period. On Day 1 and 14 of each     treatment period vital signs will be assessed and adverse event (AE)s will be recorded     throughout the total duration of the study (approximately 12 weeks).   "
97158|NCT02014467|"     This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12     month treatment in Chinese postmenopausal women with osteoporosis at increased risk of     fracture.   "
97159|NCT02014454|"     The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops     in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm     newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will receive     propranolol eye drops treatment until retinal vascularization will be completed.      Propranolol concentrations will be measured on dried blood spots during the first 3 days of     treatment and at the steady state. Cardiovascular and respiratory parameters will be     continuously monitored. Blood samplings checking metabolic, renal and liver functions will be     performed periodically, as well as cardiac function, in order to verify the treatment safety.     Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment,     the ROP progression and the possible complications.   "
97160|NCT02014441|"     The primary objective was to estimate the proportion of participants with detectable     talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after     administration of talimogene laherparepvec within the first 3 cycles.   "
97161|NCT02014428|"     To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the     treatment of atrophic vaginitis.   "
97162|NCT02014415|"     The investigators hypothesize that there is liver injury (inflammation, fibrosis, cirrhosis)     in adults with Alpha-1 Antitrypsin Deficiency (AATD), which is asymptomatic,     under-recognized, and undiagnosed. In addition, the investigators believe that the genetic     and environmental factors that play an important role in the development of alpha-1     antitrypsin (AAT) liver disease, can be identified by comparing a cohort database of clinical     disease information to linked biospecimen and DNA samples.   "
97163|NCT02014402|"     This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin     (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft     tissue, and spinal surgical procedures.   "
97164|NCT02014389|"     Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma     patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and     long wavelength stimuli should be significantly lower compared to healthy participants in     areas of visual field defects in retinal dystrophy and Glaucoma patients.   "
97165|NCT02014376|"     The purpose of this study is to assess whether SD-101 cream (3% or 6%) is effective in     treating the lesions in subjects with Simplex, Recessive Dystrophic, or Junctional     Epidermolysis Bullosa.   "
97166|NCT02014363|"     To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline     in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.   "
97167|NCT02013362|"     Phase I portion:      To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic     acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine     the recommended dosage. Also, to evaluate pharmacokinetics.      Phase II portion:      To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen     determined in the phase I portion. The primary efficacy endpoint shall be objective response     rate (ORR).   "
97168|NCT02013349|"     To evaluate the long-term safety and performance of the DESolve Novolimus Eluting     Bioresorbable Coronary Scaffold System   "
97169|NCT02013336|"     This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The     goal is to find the highest dose of MM-398 that can be given safely when it is used together     with the chemotherapy drug Cyclophosphamide.   "
97178|NCT02013219|"     This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics     of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in     participants with NSCLC.      This study has two stages. In the erlotinib group, the combination treatment will be given to     participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor     (TKI)-treatment-naive, advanced (nonresectable) NSCLC in a safety-evaluation stage and to     participants with previously untreated EGFR mutation-positive, advanced NSCLC in an expansion     stage (Stage 2). In the alectinib group, for both the safety-evaluation and expansion stages     (Stages 1 and 2), the combination will be given to participants who are treatment-naive with     anaplastic lymphoma kinase (ALK)-positive advanced NSCLC.      In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) by mouth (PO)     once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28     consecutive days during Cycle 1 and on Days 1 through 21 of each cycle thereafter. The     starting dose of atezolizumab will be 1200 mg, administered every 3 weeks (q3W) starting on     Day 8 of Cycle 1. If the starting regimen for a combination treatment is not tolerated,     alternative doses and/or schedules of erlotinib and atezolizumab or alectinib and     atezolizumab may be tested to determine potential recommended Phase 2 dose (RP2D) for that     combination treatment. In Stage 2, a potential RP2D and schedule for each combination     treatment will be investigated in an expansion cohort.      For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the     treating investigator. Study treatment will be discontinued in participants who experience     disease progression or unacceptable toxicity, are not compliant with the study protocol, or,     in their opinion or in the opinion of the investigator, are not benefiting from study     treatment. However, in the absence of unacceptable toxicity, participants with second-line or     greater NSCLC who are still receiving atezolizumab at the time of radiographic disease     progression may be permitted to continue study treatment. Time in the study is expected to be     approximately 15 months.   "
97179|NCT02013206|"     This study will evaluate the efficacy and safety of Tarceva in two groups of patients with     non-small cell lung cancer who have not been pre-treated with chemotherapy. One group,     consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other     group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a     maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.   "
97180|NCT02013193|"     The primary objective of this study is to prove the superior performance of the Ranger™     paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions     when compared to non-coated balloons at six months post-procedure when comparing Late Lumen     Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by     angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger     DCB study devices is lower than the %-mean loss of luminal diameter after treatment with     uncoated PTA balloon control devices.   "
97181|NCT02013180|"     Although Prostate Specific Antigen (PSA) is a useful marker for early detection of the     prostate cancer, its specivity is not sufficient. Several PSA variations were defined in     order to increase the specivity of the test, but they aren't much more effective than the PSA     alone for detection of disease.      In older studies reported that, serum and prostatic tissue zinc levels decreased in prostat     cancer disease.      In our study we aimed to establish the utility of serum zinc, PSA, free PSA/PSA (fPSA/tPSA),     zinc/PSA, levels for early detection of the prostate cancer.   "
97182|NCT02014350|"     To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse     Shoulder Stystem.   "
97183|NCT02014337|"     This is a study to assess the safety of the combination of mifepristone and eribulin in     patients with metastatic or locally advanced unresectable breast or other specified solid     tumors, and determine preliminary efficacy of the combination of mifepristone and eribulin in     patients with metastatic or locally advanced unresectable Triple Negative Breast Cancer     (TNBC). The structure for the study is a single arm, non-randomized, open-label, multicenter     trial with no control group. The study will be conducted at up to 11 sites, with up to 40     evaluable patients   "
97184|NCT02014324|"     Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most     frequent cause of cancer death. Accurate staging is important because it directs treatment     and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two     techniques have a complementary diagnostic range and the combined procedure is suited for     assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is     indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the     combined procedure). Second, frequently only one or two, by imaging suspected lymph node     stations, are sampled (ie. targeted approach).      Objectives: main and secondary:        1. Complete endosonographic (combined endobronchial and esophageal) staging using a single          EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.        2. Systematic mediastinal staging results in improved locoregional staging compared to          PET-CT directed assessment of the mediastinum (ie targeted approach).      Study population: Patients with potentially operable and resectable NSCLC are eligible if     there is an indication for mediastinal nodal sampling. Patients have an indication for     EBUS-TBNA.      Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same     session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET     imaging and on subsequent ultrasound are sampled.      Main study endpoint: The main study parameter is the sensitivity for locoregional disease     (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in     comparison with EBUS staging alone.   "
97185|NCT02014311|"     The aim of this study is to assess whether the clinical management of patients with recent     acute-onset chest pain without acute coronary syndrome may be optimized by a combined     coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic     strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for     invasive testing will be performed within 2 weeks after hospital discharge.      The following main hypothesis will be tested:      - Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in     a safe and optimized, cost-effective invasive treatment strategy   "
97186|NCT02014298|"     BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel     mature burn scars.      OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn     scars after NAFL-treatment.      HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and     functional appearance.      METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are     randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded     evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment     Scale; 1 = normal skin, 10 = worst imaginable scar).   "
97229|NCT02013739|"     The purpose of this study is to describe insulin resistance in a general chronic heart     failure population, in combination with muscle strength, body composition and cardiac     function.      It is assumed that insulin resistance is increased in CHF patient, and that this is related     to decreased muscle strength and decreased lean tissue mass.   "
97190|NCT02014246|"     Background:      There are two basic types of movement disorders. Some cause excessive movement, some cause     slowness or lack of movement. Some of these are caused by mutations in genes. On the other     hand, dementia is a condition of declining mental abilities, especially memory. Dementia can     occur at any age but becomes more frequent with age. Researchers want to study the genes of     families with a history of movement disorders or dementia. They hope to find a genetic cause     of these disorders. This can help them better understand and treat the diseases. This study     will not be limited to a particular disorder, but will study all movement disorders or     dementias in general. This study will perform genetic testing to identify the genetic causes     of movement disorders and dementia. Today, genetic testing can be done to analyze multiple     genes at the same time. This increases the chances of finding the genetic cause of movement     disorders and dementias.      Objectives:      To learn more about movement disorders and dementia, their causes, and treatments.      Eligibility:      Adults and children with a movement disorder or dementia, and their family members.      Healthy volunteers.      Design:      Participants will be screened with medical history and blood tests. Some will have physical     exam.      Participants will give a blood sample by a needle in the arm. This can be done at the clinic,     by their own doctor, or at home. Alternatively, a saliva sample may be provided if a blood     sample cannot be obtained.      Participants can opt to send an extra blood sample to a repository for future study. Genetic     test will be done on these samples. The samples will be coded. The key to the code will     remain at NIA. Only NIA investigators will have access to the code key. Participants can     request to receive results of the tests.      Participation is generally a single visit. Participants may be called back for extra   "
97191|NCT02014233|"     Nerves are the rate limiting factor that control muscle function. However, it is unknown if a     nutritional supplement can change the nerve-muscle interaction, and therefore alter human     performance. This study will be the first to examine the effects of omega-3 supplementation     on neuromuscular function in trained individuals.   "
97192|NCT02014220|"     Potato is one of the world's most popular foods and is widely accepted as a staple food. The     objective of this study is to determine the effect of consuming potato chips from different     cultivars on blood glucose, subjective appetite and food intake. It is hypothesized that the     chips produced from various potato cultivars will differ in their effect on blood glucose,     satiety and food intake.   "
97193|NCT02014207|"     Potato is one of the world's most popular foods and is widely accepted as a staple food. The     objective of this study is to determine the effect of altering commercial blanching and     cooling times during manufacture of frozen fries produced by the on blood glucose, satiety     and appetite. It hypothesized that the processing regime predetermines the physiologic     responses to ingested product and therefore it is possible to produce healthier product lines     of potato fries.   "
97194|NCT02014194|"     Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no     significant improvement is reached in about 30% to 40% of patients. Thus, the development of     new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in     capturing the attention of an individual compared to a neutral stimulus - has been     extensively studied. Already training attentional bias modification has been shown effective     in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate     knowledge on attentional bias in individuals with OCD through the use of a standardized     protocol developed for OCD; 2 - available to the scientific community the first specific     paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a     training protocol for reversing attentional bias in individuals with OCD.   "
97195|NCT02014181|"     Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation     and oxidative stress - a byproduct of daily stress the human body faces everyday and     especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a     mutation in sodium and chloride transport channels that results in pancreatic insufficiency,     chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic     inflammation and oxidative stress are a part of the chronic exacerbations that are a part of     cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and     antioxidative properties can help dampen these stressors on the CF lung and potentially     result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved     well-being.   "
97196|NCT02014168|"     This is a single blinded placebo controlled phase I study, to assess the safety and     immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the     Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18     and over.   "
97197|NCT02014155|"     Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ®     through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles,     the chief of these being the diaphragm which is which objectified the improvement of its     function . To monitor the action of the respiratory muscles can be used several tools such as     manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles,     or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity     of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of     45 individuals obtained by random convenience and divided into three groups, COPD     participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained     Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not     Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze     the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength,     lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual     will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at     baseline.      Hypothesis:        1. The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP)          in COPD patients regardless of whether they are enrolled in a program of pulmonary          rehabilitation (PR).        2. TMI alters the breathing pattern in COPD patients regardless of whether they were          entered into a PR program.        3. Patients with COPD who do not participate in a PR program have higher handgrip strength          compared to patients who did not participate in a PR program.        4. There is decreased activity of the sternocleidomastoid muscle due to increased activity          in the diaphragmatic muscle fibers after a period of TMI.        5. TMI in COPD patients participating in a program RP produces greater increase in MIP, the          handgrip strength, improves breathing pattern and a greater reduction in the activity of          the SCM muscle and diaphragm than in those who did not participate in a program RP.        6. There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood          pressure and increased oxygen saturation at the end of the TMI.        7. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the          training period.   "
97198|NCT02014142|"     Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS     placement on efficacy will also be examined.   "
97200|NCT02014116|"     The main purpose of this study is to see how safe the investigational drug known as LY3009120     is and whether it will work to help people with advanced cancer or cancer that has spread to     other parts of the body.   "
97201|NCT02014103|"     Conduct a retrospective study to evaluate the impact of generic conversion in adult     transplant recipients on post transplant outcomes one year prior to conversion to one year     post conversion. Variables for analysis will include but not limited to incidence of     rejection, hospital admission, changes in renal function, changes in transplanted organ     function. All tacrolimus levels and dose changes during this period will be collected and     compared. Additional pharmacokinetic modeling of this data will be performed for comparison.      The prospective study will compare othe relative bioavailability and steady-state     pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study     including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.   "
97204|NCT02014064|"     Methamphetamine (MA) abuse is a national public health concern. People who are dependent on     MA have problems with mental functions (e.g., learning, remembering, focusing attention,     solving problems). Such problems can interfere with their treatment for MA abuse, and thereby     may promote continued drug use. While the effects of MA have been studied in rodents and     non-human primates, its effects on the human brain have not been well characterized.      This is a study of nontreatment seeking individuals who use MA compared to individuals who do     not use MA(control participants). The study has three goals: 1. it aims to identify the brain     regions and pathways that may contribute to the problems of MA abusers in performing mental     tasks; 2. it will serve as a double-blind, placebocontrolled,within-subjects study to     determine the safety and tolerability, and positive effects of MA in MA-abusing volunteers     treated with atomoxetine or placebo; 3. It aims to compare the brain activity as measured by     structuraland functional magnetic resonance imaging (fMRI). These are noninvasive brain     imaging procedures, that will be used to study brain function while control and MA using     participants take atomoxetine or placebo and perform tests of memory and concentration.      MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the     participants to proceed with the study they will participate in two inpatient phases of the     study that will occur in the UCLA research setting, the General Clinical Research Center. The     first inpatient stay will be 15 days, and the second will be a 9 days stay that includes drug     administration and assessments. There will be at least a two week interval between inpatient     phases. During the inpatient phases participants will receive alternating study drugs;     atomoxetine or placebo and four sessions of IV MA administration or placebo.      The study schedule for control participants will include a 1-day outpatient screening and two     phases of outpatient administration of atomoxotime or placebo with a two week study drug free     interval between the phases. Four to five of the outpatient study visits will involve     cognitive tests and brain imaging studies.   "
97205|NCT02014051|"     The purpose of this study is to investigate tolerability when SyB C-1101 is orally     administered twice daily for 14 consecutive days to the patients with recurrent/relapsed or     refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum     tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics     and antitumor effects will also be investigated.   "
97206|NCT02014038|"     Health status information and physical activity level will be collected longitudinally on a     large group of individuals who are ultramarathon runners at the time of enrollment to     determine if very high levels of physical activity alter health risks compared with sedentary     or moderately active lifestyles.   "
97207|NCT02014025|"     The purpose of this study is to compare short-term and long-term efficacy of laparoscope     hepatectomy and open hepatectomy, evaluate the safety and efficacy of laparoscope hepatectomy     the PHC with a tumor size of 5～10㎝,and provide class B evidence based medicine for     laparoscope hepatectomy for PHC with a tumor size of 5～10㎝.   "
97208|NCT02014012|"     Arterial stiffness has been suggested as an independent risk factor for the development of     coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established     index to quantify arterial stiffness. Therefore, we try to investigate the correlation     between PWV values and cardiovascular complications like stroke, acute renal failure, or     perioperative myocardial infarction after cardiac surgery.   "
97209|NCT02013999|"     Using the upper extremity rehabilitation program developed by virtual reality would help the     recovery upper extremity function in patients with stroke.   "
97210|NCT02013986|"     Etomidate is an unique drug used for induction of general anesthesia and sedation. Adrenal     cortical inhibition by etomidate has received much attention. However wether the circadian     rhythm and pulse secretion pattern of cortisol in children are the same as that in adults is     not known. Moreover, the effect of etomidate on circadian rhythm changes and clinical     outcomes has never been carefully studied in children undergoing surgery. Our hypothesis is     that etomidate can relieve the changes of circadian rhythm of salivary cortisol in children     for 24-48 hours，and this does not make clinical outcomes worse postoperatively.   "
97211|NCT02013973|"     The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro     fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone ),     in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI (BMI=body     mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than does     assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12 oocytes     during COH.   "
97212|NCT02013960|"     1. Comparison between the duration of time from the beginning of cervical preparation until          abortion, between sublingual misoprostol and the combination of sublingual misoprostol          with laminaria for second trimester medical termination of pregnancy (TOP).        2. Comparison between the adverse event rate following Sublingual misoprostol only vs.          Sublingual misoprostol and laminaria given for pregnancy termination.        3. Comparison between the levels of satisfaction rate of women who underwent pregnancy          termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.   "
97213|NCT02013947|"     The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia,     dyslipidemia and hypertension) and it is a risk factor for the development of type 2 diabetes     and atherosclerotic cardiovascular disease. There are several definitions for the metabolic     syndrome. The AHA/NHLBI (American Heart association/National Heart Lung Blood Institution)and     IDF (International Diabetes Federation)2009 criteria are frequently used to comparing data     from studies. Prevention or reduction of obesity and lifestyle modification with physical     activity is the main therapeutic goal in patients with metabolic syndrome. Recent studies     have shown that exercise in moderate altitude or in moderate hypoxia improved glycemic     parameters. The influence of training in moderate altitude on circulating metabolites and     hormones in terms of substrate utilization is unclear. The adiponectin seems to play an     important role in the homeostasis of adipose tissue and in the pathogenesis of the metabolic     syndrome and physical activity seems to have a positive effect on adiponectin concentrations.     In this study with randomized controlled pretest-posttest-design we want to investigate the     effects of physical activity in moderate hypoxia on biomarkers of metabolic syndrome.   "
97214|NCT02013934|"     The objective of this study is to assess the benefit and tolerability of a probiotic product     in subjects with increased susceptibility to common cold.   "
97230|NCT02013726|"     Primary:      In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI     (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in     detecting breast cancer than breast tomosynthesis.      Secondary:        1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly          classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.        2. In women with heterogeneous or dense breast tissue, the area under the receiver          operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast          tomosynthesis.        3. Combining the use of MBI and breast tomosynthesis will provide performance superior to          either technology alone, as manifest by a superior ROC curve area.   "
97215|NCT02013921|"     Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in     different cancer types.      It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it     to the overall calculation of physical activity in clinical practice.      To assess the AP, two types of methods are validated : the subjective method using a     questionnaries and objective method using a pedometer , accelerometer or measures calorimetry     .      Subjective method shows , good acceptability by patients and low cost but can sometimes lead     to poor estimation of the level of activity.      Objective methods obviously increase the accuracy of assessments but are more difficult to     use for epidemiological studies , less accepted by the patient and more expensive.      In this study the investigators will measure the spontaneous Daily Physical Activity by both     methods andd evaluate the correclation.   "
97216|NCT02013908|"     Acupuncture is widely used for managing acute and chronic pain conditions. In the context of     an emergency department (ED), patients often present with non-emergent acute pain symptoms.     This may result in a delayed triage process and inefficient emergent management. An     integrative patient-care approach in emergency departments has been explored that may improve     patient satisfaction and promote efficient use of healthcare resources for non-emergent     patients in the ED. This implies there is a potential role for acupuncture in such contexts.     The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an     add-on intervention for patients with non-emergent acute musculoskeletal pain and primary     headaches in an ED setting.      Hypotheses of this study are as follows:        1. A single session of add-on acupuncture, with standard ED management, can reduce pain          levels in non-emergent acute pain, compared to standard ED management alone.        2. A single session of add-on acupuncture to standard ED management can reduce additional          consumption of healthcare resources for management of non-emergent acute pain, compared          to standard ED management alone.      This study aimed to include 40 participants, 20 in the acupuncture plus standard ED     management group and 20 in the standard ED management alone group.   "
97217|NCT02013895|"     Preoperative evaluation of future remnant liver function is critical for patients undergoing     hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening     postoperative hepatic failure, and its underestimation can lead to a lost opportunity for     potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has     been estimated preoperatively using computed tomography (CT) volumetry. CT can provide     precise anatomical information, and the remnant liver volume, measured by CT volumetry, has     been reported to be an effective predictor of hepatic dysfunction after hepatectomy. However,     the indirect estimation of liver function by CT volumetry is reliable only when the function     is assumed to be homogenous over the whole liver.   "
97218|NCT02013882|"     We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of     O2:N2O 1:1 L/min with desfluraene 12%.      The objective of this study is to identify time to achieve alveolar concentration of     desflurane at1, 2, 3, 4, 5 and 6%.   "
97219|NCT02013869|"     To study the Flow-I breathing circle during low flow general anaesthesia, whether this     non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar     concentration) and lower consumption of inhaled agent   "
97220|NCT02013856|"     Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease     (CVD). The protective effect may be ascribed to compounds contained within these foods,     called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of     flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine.     There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially     alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the     acute and chronic effects of apple derived flavanols on some risk markers for CVD.   "
97221|NCT02013843|"     In the present study the effect of a community-based treatment of overweight and obese     children is analyzed. The treatment-method is based on the principals and the method used in     the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by     the change in body mass index standard deviation score, change in blood pressure standard     deviation score, quality of life and concentration of fasting blood lipids and glucose during     one year of treatment.   "
97222|NCT02013830|"     This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus     intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The     anticipated time on study treatment is 3-12 months.   "
97223|NCT02013817|"     This study will evaluate the efficacy and safety of intense combination treatment including     MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients     with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5     years.   "
97224|NCT02013804|"     This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514)     to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in     adult subjects with solid tumors.   "
97225|NCT02013791|"     This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in     patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied     in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will     participate in Stage 2 of this study.   "
97226|NCT02013778|"     Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the     oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial     chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3     design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort     of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.   "
97227|NCT02013765|"     This study will evaluate the efficacy and safety of intravenous Herceptin in patients with     metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The     anticipated time on study treatment is until disease progression.   "
97228|NCT02013752|"     The purpose of this study is to determine whether a modified perineum protection device can     reduce tearing during delivery.   "
97770|NCT02006446|"     In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need     to be improved in order to increase the success of assisted reproduction treatments.      The aim of this study is to determine whether the presence of sperm head vacuoles is     associated with sperm DNA alterations.   "
97231|NCT02013713|"     The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes     suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at     increased cardiovascular risk.      The frequency of familial hypercholesterolemia in cardiologic is little studied and remains     unknown, and there is little data on the profile of patients, diagnostic methods and     management.      Main objectives:        -  Establish a monitoring patients with hypercholesterolemia Family cardiology in France        -  Characterize the Family hypercholesterolemia in cardiology, including assessing the          frequency of the most severe forms, which are at higher cardiovascular risk.   "
97232|NCT02013700|"     This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in     followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot     phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem     cells and in the randomized phase subjects will receive either allogenic mesenchymal stem     cells or matched placebo.   "
97233|NCT02013687|"     This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate     the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant   "
97234|NCT02013674|"     Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI     scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase     II study intended to gain additional safety and efficacy assessments among two dose levels     previously studied in a phase I setting.   "
97235|NCT02013661|"     The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening     among four types of suture one week after periodontal surgery.   "
97236|NCT02013648|"     This is a randomized phase III open-label, multicenter trial evaluating standard induction     therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose     cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML   "
97237|NCT02013635|"     Cerebral venous thrombosis is considered as a rare type of stroke with an annual incidence of     3 to 4 per million people. It occurs generally in young patients (mean age of occurrence = 40     years) and principally in young females (75%) generally in pregnancy or oral contraceptive     use situations.      The onset may be acute (less than 2 days), subacute (between 2 and 30 days) or chronic (more     than 30 days). The clinical presentation is highly variable and includes patients with only a     mild headache, others with focal neurological deficits and a few with a dramatic syndrome and     a coma. Moreover the evolution can be very different with unpredictable outcome: more often     it is favorable with a low mortality rate, but in some cases it can be a worse course. The     aim of this study is to evaluate the correlation of some biological markers: thrombin     generation test and D-Dimers (marker of fibrin generation and degradation) with the type of     onset or the wide spectrum of clinical presentations or the different modes of evolution.      All patients over 16 years ago may be included in the program when CVT diagnosis is proved by     magnetic resonance angiography (MRA). For each included patient, there are four blood assays:     the first just at the time of diagnosis and before the beginning of treatment, the second     before the beginning of the oral anticoagulant treatment. The third assay is done in the     third month at the time of a MRA. The last assay is made one month after the end of the     anticoagulant treatment or in 12th month after the beginning of the disease if the treatment     goes on.      For each sample, the investigators perform a thrombin generation test and a D-Dimers     measurement.   "
97238|NCT02013622|"     The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole     monotherapy in the improvement of early-episode schizophrenia through the assessment of     social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as     episodes occurring ≤ 5 years after the onset of the first episode.   "
97239|NCT02013609|"     To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment     in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective     serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI)     response in a school or work environment.   "
97240|NCT02013596|"     The purpose of this study is to compare the effect of TEAS pretreatment and treatment on     hepatic and renal dysfunction induced by pneumoperitoneum in patients undergoing laparoscopic     surgeries.   "
97241|NCT02013583|"     The purpose of this protocol is to create a registry for patients diagnosed with Glucose     Transporter Type 1 Deficiency (G1D), or patients experiencing symptoms consistent with G1D     but not yet diagnosed, to enter medical information for physicians and other health     researchers to analyze to increase the understanding of G1D and any sub-diagnoses.   "
97242|NCT02013570|"     The purpose of the present study is the clinical assessment of the efficacy of preincisional     peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children     undergoing adenotonsillectomy.   "
97243|NCT02013557|"     Purpose: The purpose of this study is to see whether a text-message reminder system will     increase the number of women who complete their diabetes screening after delivery.      Study Design: Prospective randomized control trial      Hypothesis: Gestational diabetics will be significantly more likely to follow up with their     postpartum screening for diabetes if they receive text-message reminders to set up their lab     appointment compared to those who receive usual care.   "
97244|NCT02013544|"     The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on     symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects     exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.   "
97245|NCT02013531|"     The purpose of this study is to investigate the efficacy and safety of flexibly dosed     adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety     symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor     (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.   "
97261|NCT02013115|"     Infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome     usually need the second or more pulmonary surfactant and is easier to developing to     Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome,     Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is     Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of     Brochopulmonary dysplasia.   "
97246|NCT02013518|"     A total of 200 home dwelling participants, who fulfil the inclusion criteria, Alzheimer's     disease, will be recruited from three hospitals in Norway.      The intervention is based on a standardized manual, and consists of 11 weekly one-hour     sessions, which are organized into six thematic modules.      The content of each session is specified by a treatment manual, which additionally consists     of worksheets, suggestions for homework in between sessions and letters to the caregivers     (the German manual: Werheid & Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner &     Tonga, not published). The treatment will be conducted by experienced health staff (nurses,     psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge     about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the manual     before study inception, participate in a two-day training seminar and will regularly be     supervised.      The control condition will be offered treatment as usual at the participating the memory     clinics.      The hypothesis is that the participants in the intervention group will report less depression     and increased self efficacy as compared with the control group.      We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to     examine the feasibility of the study protocol and do want to include these patients in the     study population.   "
97247|NCT02013505|"     The investigators hypothesised that a video based patient education will help patients     understand the process of colon cleansing prior to a colonoscopy procedure and hence will     result in clean colons that will may help physician perform a better quality examination.   "
97248|NCT02013492|"     This pilot trial studies propranolol hydrochloride in treating patients with locally     recurrent or metastatic solid tumors that cannot be removed by surgery. Propranolol     hydrochloride may slow the growth of tumor cells by blocking the use of hormones by the tumor     cells.   "
97249|NCT02013479|"     Our aim is to investigate if selenium supplementation versus placebo adjuvant to the standard     treatment with levothyroxine (LT4) in patients with autoimmune thyroiditis will lead to     improved thyroid specific quality of life, and reduced autoimmune activity. The trial will     include 472 participants (2 X 236) from four clinical trial sites.   "
97250|NCT02013466|"     In this study healthy older adults are requested to consume 4 different high-protein     nutritional supplements. Each subject will visit the site 4 times and at every visit they     will consume 1 of the 4 products after which a series of blood samples will be taken. The     blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours     after consumption.   "
97251|NCT02013453|"     The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to     standard chemotherapy can improve progression free survival in patients with head and neck     cancer.   "
97252|NCT02013427|"     This study is designed to examine brain properties for placebo response in chronic back pain     patients. The investigators have preliminary data indicating that, in blinded clinical trial     studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can     be subdivided into placebo responders and non-responders, and these differences are     PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical     utility and that its properties can be studied by human brain imaging techniques. In Phase I     of the study, the investigators seek to identify brain imaging parameters that predict the     propensity for the placebo response in an independent CBP cohort. In Phase II, the     investigators will evaluate the interaction between placebo response and medication treatment     in individuals stratified as placebo responders versus non-responders. This research is     designed to critically assess the neurobiology of placebo analgesia for chronic pain in a     partially-blind clinical trial.   "
97253|NCT02013414|"     The objective of the proposed study is to evaluate a new, molecular image directed,     three-dimensional (3D) ultrasound guided biopsy system in human patients. The current biopsy     uses ultrasound imaging as guidance. However, the procedure uses two-dimensional (2D)     ultrasound images and has sampling errors thus some cancers can be missed from the standard     2D image-guided biopsy. In this study, an FDA-approved ultrasound device will be used to     obtain three-dimensional (3D) images of the prostate from a commercially available ultrasound     scanner. The clinician can use the 3D images to guide biopsy, record the core location of the     biopsy sites, and perform re-biopsy to the same sites in a patient follow-up examination.     This system can also use images from magnetic resonance imaging (MRI) or positron emission     tomography (PET) and then fuse PET or MR images with 3D ultrasound images to guide the needle     to a suspicious tumor target as seen on MRI or PET. We think that this fusion targeted biopsy     technology will help to improve the accuracy of the current systematic biopsy approach for     prostate cancer detection.   "
97254|NCT02013401|"     The central aim of this study is to assess mother-infant communication via behavioral,     physiological, and affective indices under conditions where distal stressors may not be     directly detectable by the infant.   "
97255|NCT02013388|"     A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of     N91115.   "
97256|NCT02013375|"     Related donor stem cell transplantation using the alemtuzumab/ TBI platform has been shown to     be a safe strategy to cure severe sickle cell disease. However, due to a lack of suitable     donors, many patients cannot benefit from this strategy. Alternative donor sources are     desperately needed to fill this gap. Nearly all patients will have a haploidentical family     member who would be able to donate. The use of post transplantation cyclophosphamide has     greatly improved the outcome of haploidentical stem cell transplantation. The investigators     propose to combine this with alemtuzumab/TBI conditioning.   "
97257|NCT02013167|"     The primary objective was to evaluate the effect of blinatumomab on overall survival when     compared to standard of care (SOC) chemotherapy.   "
97258|NCT02013154|"     A study to evaluate the safety and tolerability of DKN-01 in combination with weekly     paclitaxel in participants with refractory/recurrent esophageal, gastro-esophageal junction     and gastric cancer.   "
97259|NCT02013141|"     This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children,     and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV)     over 60 minutes   "
97260|NCT02013128|"     The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in     combination with Ibrutinib in patients with advanced hematologic malignancies.   "
97262|NCT02013102|"     The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment     of Myelodysplastic Syndrome.   "
97265|NCT02013063|"     A small proportion of patients with lung cancer present with a solitary pulmonary nodule     (SPN). This is an important group of patients because if it is lung cancer, presentation as a     SPN represents early disease, which following surgery has a high 5 year survival rate.     However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical     guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give     more information about the SPN and may indicate if it is likely to be lung cancer. However in     many cases it does not and current practice is to monitor the SPN with a series of CT scans     over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If     no changes are observed over 2 years the SPN is considered not lung cancer. This is both     expensive for the National Health Service (NHS) and worrying for the patient in terms of     monitoring CT costs and delayed treatment due to length of time to diagnosis.      This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast     Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN     and the investigators will look to see if information from either scan or combined     information from both scans may be better in the diagnosis of early stage lung cancer. The     investigators will also undertake a review of previous studies that have used these scans and     use data from both the review and the trial to look at the cost effectiveness of using DCE-CT     in the diagnosis of SPN.      The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires     a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or     within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take     place to normal NHS care, however we will collect clinical and outcome data over the next two     years.      The study is coordinated by Southampton University clinical trials unit. Recruitment between     January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected     by the end of 2018.      The study is funded by the NIHR-HTA   "
97266|NCT02013050|"     To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment     for the treatment of head and neck cancer.   "
97267|NCT02013037|"     All individuals who receive a heart transplant are at risk for developing antibody-mediated     rejection (AMR). An antibody is a protein produced by the body's immune system when it     detects a foreign substance, called an antigen. The mechanism of an antibody is to attack an     antigen. In antibody mediated rejection, antibodies will attack the transplanted heart,     causing injury to the heart. The purpose of this investigation is to determine if a study     drug, called Eculizumab (Soliris), prevents antibody-mediated rejection in patients with high     antibody production and prolongs long-term cardiac transplant survival.   "
97268|NCT02013024|"     Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to     slow freezing.   "
97269|NCT02013011|"     This study is to evaluate effects of recruitment maneuver in patients undergoing robotic     assisted radical prostatectomy.   "
97270|NCT02012998|"     To evaluate the immune response to Hepatitis B virus in children who have been primed with     HEXAVAC or INFANRIX HEXA 10 years ago.   "
97271|NCT02012985|"     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering     urinary oxalate levels in patients with primary hyperoxaluria.   "
97272|NCT02012972|"     For national antiretroviral therapy (ART) programs, the most important health system goals in     reducing morbidity and mortality among HIV-infection patients are to initiate treatment as     early as eligibility criteria allow and to achieve the highest possible long-term retention     of patients on ART. In South Africa, cohort data have consistently found high attrition among     ART patients, with the combined cumulative outcomes of death and loss to follow up averaging     25-40% over the first five years after ART initiation. Like many other middle income     countries, South Africa also faces very high rates of non-communicable diseases (NCDs) and     NCD risks. Despite this, there are virtually no studies looking at interactions between ART     and NCDs, and none that have considered the effect of NCDs and NCD risk factors on achieving     the second health system goal mentioned above: long term retention on ART.   "
97273|NCT02012959|"     The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases     and maintains serum sodium concentrations in children and adolescent subjects with euvolemic     or hypervolemic hyponatremia.   "
97274|NCT02012946|"     This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing     major non cardiac surgery, during and after the continuous infusion of levosimendan or     dobutamine.   "
97275|NCT02012933|"     Lambert-Eaton Myasthenic Syndrome (LEMS) is a rare autoimmune disorder which affects the     nerve-muscle junction. The major symptoms of LEMS are progressive muscle weakness. Many     patients experience other symptoms like dry mouth or impotence. Congenital Myasthenia (CM) is     an inherited disorder with similar affects and symptoms.      3,4-Diaminopyridine (DAP) is an experimental drug that has improved strength in some subjects     with (LEMS). There are no other accepted treatments for LEMS and DAP has relatively few side     effects.   "
97276|NCT02012920|"     The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics     and activity of VT-464, a lyase-selective inhibitor of CYP17, in patients with     castration-resistant prostate cancer (CRPC).   "
97277|NCT02012894|"     Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to     laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the     relationship between LSG and GER the majority reported only changes in symptoms and     manometric data, while assessment of GER using 24-hour pH monitoring is lacking.      The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.   "
97278|NCT02012881|"     The purpose of this study is to determine the effect of a four months school-based physical     activity intervention on cognition, academic achievement, physical activity and aerobic     fitness in 12-15 year old adolescents.   "
97279|NCT02012868|"     Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients     undergoing bariatric surgery.      Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of     them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However     these studies are biased by a huge number of drop outs. The drop out rate in the studies are     around 60 percent.      The Investigators state that the prevalence of OSA among patients undergoing bariatric     surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is     significant on severity of OSA. The Investigators state that we can perform a study without a     huge number of dropouts.   "
97287|NCT02012764|"     This is a 12-month, prospective, observational cohort trial involving Primary Care Trusts     (PCTs) wishing to take part in the study and the Early Arthritis Clinic (Anti-CCP sub-clinic)     at Chapel Allerton Hospital. The approximate duration of subject participation will be 12     months and the approximate total duration of the study will be 10 years. Patients who have     not developed inflammatory arthritis within the 12 month period will have the opportunity to     continue follow up within the clinic on an annual basis with additional visits as clinically     indicated until the development of IA.   "
97280|NCT02012855|"     The increase in fat (i.e. triglyceride) in the blood after a meal is a well-established risk     factor for heart disease (Nordestgaard et al. 2007). Endurance exercise is beneficial for     improving the blood lipid response to a subsequent meal; that is, the appearance of fat     (triglyceride) in the blood is less after a meal if endurance exercise was performed shortly     before (i.e. within half a day) of the meal (Petit et al. 2003). This benefit of exercise is     unfortunately negated if the after-exercise food choice to replace the calories expended     during exercise is one containing high glycemic index carbohydrates. For example, if a high     glycemic index carbohydrate is consumed after an evening exercise session, the exercise no     longer has an effect of lowering triglyceride in the blood after a meal consumed the next     morning (Harrison et al. 2009; Burton et al. 2008). Very rarely do people perform an exercise     session and then fast until their next meal hours later. The more common practice is to     consume food immediately after the exercise to enhance recovery and because hunger is     stimulated with exercise. Consuming carbohydrate with a low glycemic index has been shown to     reduce the level of fat in the blood following a subsequent meal (Gruendel et al. 2007). To     date, no studies have examined the effects of consuming a low-glycemic index meal after     exercise on the blood fat response to a subsequent meal. The specific objective of our     research is to determine the effect of consuming low glycemic index lentils after an     endurance exercise session on the blood fat (triglyceride) response to a subsequent meal.     Twenty-five overweight or obese men will have their blood triglycerides measured four times     over six hours after a high-fat morning meal following four different conditions, in a     randomized, counterbalanced, cross-over design (i.e. the 25 subjects will each participate in     all four conditions, where the order of conditions for each person is randomized): 1) After     exercise (90 minutes of moderate intensity walking) is performed the evening before, followed     by caloric replacement with a high-glycemic index meal (i.e. white bread and instant mashed     potatoes); 2) After the same exercise is performed the evening before, followed by caloric     replacement with a lentil-based meal; 3) After the same exercise is performed the evening     before, followed by fasting; 4) After a no exercise/ no meal condition (i.e. control     condition). In addition to measuring blood triglycerides we will measure blood insulin, free     fatty acid, high density lipoproteins, low density lipoproteins, and glucose levels as these     are also related to cardiovascular disease risk and may be altered with exercise and lentil     consumption. We will also measure the muscle's ability to burn fat (i.e. fat oxidation) by     assessing respiratory gases (oxygen consumption and carbon dioxide output) after the high-fat     meal because we expect exercise and lentils to increase fat oxidation. Our expected results     are that consuming lentils after endurance exercise will lower the blood triglyceride     response to a subsequent meal compared to exercise alone or when high-glycemic index     carbohydrates are consumed after the exercise.   "
97281|NCT02012842|"     The aim of this study is to evaluate the effect of periodontal treatment on systemic     inflammation and quality of life of individuals with metabolic syndrome. There will be a     randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes     (Hospital de Clinicas de Porto Alegre) and outpatient dental clinic of the Faculty of     Dentistry, Federal University of Rio Grande do Sul (UFRGS), who have a diagnosis of metabolic     syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it     will be immediately periodontal treatment (test group) and another arm which will be held     later periodontal treatment (control group). The study will last six months , and after this     period, the control group will receive the same treatment to the test group . A     socio-demographic questionnaire will be applied by a trained interviewer , so that data on     income, education , behavioral habits , medical and dental history . Complete periodontal     examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3     and 6 months after periodontal treatment . In addition to the tests required for the     diagnosis of metabolic syndrome , will be asked the same blood tests at 3 and 6 months after     periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides ,     C-reactive protein). Aliquots of plasma from blood collected in each experimental point are     stored at -80 ° C for analysis of interleukin- 6, Tumor Necrosis Factor- α (TNF-α) , Glucagon     Like Peptide-1 (GLP-1) and adiponectin. At each clinical examination will be collected     gingival crevicular fluid , supra and subgingival biofilm . Versions of the questionnaires     validated in Brazil (OHIP-14)and WHOQoL Bref will be applied to assess quality of life at     baseline and after 6 months of the study . The primary outcome will be change in glycated     hemoglobin and secondary outcomes will be changes in serum fibrinogen and C-reactive     protein.The hypothesis of this study considers that periodontal treatment can alter the serum     levels of C-reactive protein, fibrinogen and glycosylated hemoglobin in patients with     metabolic syndrome and thereby contribute to improved quality of life. The objective of this     study is to evaluate the effect of periodontal treatment on systemic inflammation and quality     of life of individuals with metabolic syndrome.   "
97282|NCT02012829|"     Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient     interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC)     screening in France The qualitative data indicated that improvement was needed in     patient-centered communication. Educational material was developed based on these     triangulated data with two different scenarios to improve communication with patients: one     for a compliant patient, another for a non compliant patient The hypothesis is that a brief     intervention on GPs can improve the patients' participation rate to colorectal screening      Method : cluster randomized control trial (cluster unit : GPs practices) With a brief     intervention on a randomized population of GPs in the district of Val d'Oise Inclusion     criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal mass     screening   "
97283|NCT02012816|"     The Centre for Infectious Disease Research in Zambia (CIDRZ) and researchers from the     University of North Carolina at Chapel Hill (UNC) have partnered to pilot an peer-referral     incentive program to increase voluntary medical male circumcision (VMMC) uptake in Zambia.     The program allows each man coming for circumcision to refer up to 5 uncircumcised men in     their social network for VMMC services and receive a monetary reward for each successful     referral. The peer-referral program offers several advantages over traditional     demand-creation approaches that rely on employing mobilizers or community health workers     (CHWs). The amount of the monetary incentive will be analogous to the amount of incentive     that CHWs might receive for comparable effort, making the program suitable for large-scale     expansion. The effect of the peer-referral program on uptake of VMMC services will be     evaluated using a rigorous methodology proposed by UNC researchers.   "
97284|NCT02012803|"     The intention is to compare prospectively operative and conservative early functional     rehabilitation protocol in treatment of total achilles tendon rupture. To compare these     treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of     life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items     (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of     motion between ankles, subjective result, isokinetic calf muscle strength). The investigators     also study MRI-imaging for both legs and compare including achilles tendon elongation and     muscle volume correlations to Leppilahti-score results between these two treatments.     Follow-up time is 18 months.      Hypothesis is that operative treatment offers no benefit in comparison conservative     treatment, with identical rehabilitation protocol.   "
97285|NCT02012790|"     Migraine is a widespread, debilitating, chronic pain disorder and a major public health     challenge. Most conventional, pharmaceutical treatments fail to give satisfactory long-term     relief and their repeated use can have important side effects. This project involves     implementation of substantial dietary changes in adults with migraine. Our goal is to test     the hypothesis that a causal relationship exists between migraine symptoms and the amount and     proportions of foods consumed containing defined amounts of polyunsaturated fatty acids.      Significant findings supporting the hypothesis will lead to a major shift in both prevention     and management of migraine and other chronic pain disorders. Emphasis is on low-cost, health     improvement strategies utilizing specific dietary modifications for pain management, based on     solid clinical research evidence.   "
97286|NCT02012777|"     Propanolol is a beta blocker which has been found to inhibit the ability of epinephrine to     upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose of     this pilot study is to administer one dose of propanolol to children with sickle cell disease     and to measure pre and post dose red cell adhesion. The hypothesis is that a single dose of     propanolol will decrease red cell adhesion to laminin and endothelial cells as compared to     baseline.   "
97288|NCT02012751|"     The Nevus doctor is a dermatoscopy based computer decision support tool to assist general     practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the     program Nevus doctor is to help GPs increase their diagnostic accuracy, in particular     regarding the selection of suspicious PSLs that need biopsy or referral to specialist health     care for further assessment. The aim of this study is to investigate the diagnostic     performance of the decision support tool in a primary care setting in Norway. We hypothesize     that the diagnostic accuracy of the computer program Nevus doctor is better than the     performance of the GPs.   "
97289|NCT02012738|"     Escalating violence is omnipresent in South African townships and can be traced back to two     core mechanisms: a trauma-related hyper-arousal and a positive rewarding perception of     violence. In the past, there was no therapeutic intervention available addressing both,     trauma and the so-called appetitive aggression. The University of Konstanz has developed a     culturally sensitive and scientifically based short-term intervention for the treatment of     traumatized patients, the Narrative Exposure Therapy (NET), that has proven its effectiveness     in various randomized clinical studies in different war-affected populations. Recently, the     NET has been adapted for the forensic offender rehabilitation (FORNET) by also addressing the     perpetration of violence related to a self-rewarding perception of the exposure with     violence. It has shown to be effective in reducing the number of committed offenses in a     perpetrator sample in Burundi and to reduce PTSD symptoms in a perpetrator sample in the     Democratic Republic of the Congo. In this study, we investigated the therapeutic efficiency     of FORNET in a randomized clinical control trial with a sample of former offenders of the     townships of Cape Town. In addition to the previous studies, we specifically addressed the     context of ongoing stress and linked our findings to epigenetic markers of stress and     violence. Participants were followed over a period of up to 25-months post-treatment. The     FORNET was also disseminated to local staff of our collaboration partners from the South     African Universities and an organization working in the townships to warrant sustainability     of the therapeutic intervention.   "
97290|NCT02012725|"     This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced     steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current     clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP     cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients.     Participants will not receive a study drug or placebo and will not be randomized. A total of     250 participants will be enrolled into this study.   "
97291|NCT02012712|"     Purpose: To examine the impact of a personal health record (PHR) on medication use safety     among older adults.      Background: Online PHRs have potential as tools to manage health information. We know little     about how to make PHRs accessible for older adults and what effects this will have.      Methods: A PHR was designed and pretested with older adults and tested in a six-month     randomized controlled trial. After completing mailed baseline questionnaires, eligible     computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or     serve as a standard care control group (n=273). Follow-up questionnaires measured change from     baseline medication use, medication reconciliation behaviors, and medication management     problems.   "
97292|NCT02012699|"     The objectives of this project at UNMC and other IRB approved sites is to implement and     maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository     for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core     support services for future IRB approved multidisciplinary research on cancer and other     chronic diseases carried out by members of the Fred and Pamela Buffett Cancer Center as well     as internal and external research collaborators from different participating     institutions/centers.   "
97293|NCT02012686|"     The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation     (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after     thyroidectomy.   "
97294|NCT02012673|"     Rationale:      The combined data from 3 studies outside the Unites States investigating the Lung Volume     Reduction Coil system (RePneu LVRC) showed statistically significant improvements in     pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post     treatment. 24 months post treatment the improved pulmonary function and exercise capacity are     slightly decreasing. Retreating the patient with the LVR coil system in other parts of the     lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity     and quality of life and may reduce the rate of decline.      Objective:      To investigate the safety and feasibility of re-treating patients with severe Chronic     Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.   "
97295|NCT02012660|"     The objective of this study is to explore the relationship between moderate to severe     hyponatremia and heat.   "
97296|NCT02012647|"     The purpose of this study is to examine the brain changes in people with Parkinson's Disease     (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not     have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and     challenging. Deep brain stimulation is an established surgical treatment that is effective     for the treatment of PD, but the details of why it helps are not known. In order to achieve     maximum benefits from this treatment, it is important to understand how it changes the brain.     Specifically, the investigators will study electrophysiology, which is the study of how the     brain conducts electrical messages to the rest of the body. To do this, the investigators     will use transcranial magnetic stimulation (TMS), which is a painless and non-invasive     procedure. They will also conduct motor physiology experiments of the upper and lower limbs     to collect data about skeletal muscle movement. The data from this study will help explain     whether the electrical changes in the brain have any relation to the physical benefits     patients with Parkinson's Disease sometimes receive from DBS surgery.   "
97297|NCT02012634|"     A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic     Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer   "
97298|NCT02012621|"     The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate     (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a     TFV-based regimen. Using DBS will allow the investigators to assess this simple method to     measure drug exposure in the clinical setting. The investigators hypothesize that TFV-DP     levels will be lowest in individuals with a detectable viral load and highest in those with     viral suppression.   "
97300|NCT02012595|"     AIM: Investigate wether there are differences in the parasympathetic nervous system in     Parkinsons patients compared to controls.      MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous     system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged     40-80 in our study. The participants will receive a careful medical examination, including a     neurological examination, as part of the inclusion process. The subjects also have an MRI     scan of the brain. Then PET/CT scans with [11C]donepezil are conducted - once for the upper     abdominal region and once for the head region. For evaluating the function of the     parasympathetic nervous system gastric emptying time, heart rate variability and salivary     flow will be measured. These measureless will be correlated to the PET findings.      PERSPECTIVES: The study will potentially result in the development of a PET ligand for     imaging the parasympathetic nervous system. This will have applications for research in     Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic     nervous system is involved   "
97301|NCT02012582|"     In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and     pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with     moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males)     receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts     (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study     for all patients will be Day 14; adverse events and concomitant medications will be     documented throughout the study.      Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of     metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of     VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure     heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG,     laboratory examinations (clinical chemistry, liver function, haematology/coagulation,     urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined     in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure     (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline,     pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy     Intensity Level (TIL).   "
97302|NCT02012569|"     The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the     bleeding time in the donor site of skin grafting.   "
97303|NCT02012556|"     The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1)     profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated     administration once daily for 14 consecutive days. Secondary objectives include the     evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous     injections.   "
97304|NCT02012543|"     The administration of agar jelly may increase the number of defecation and the volume of     feces, and then may improve fecal condition in chronic constipated patients.   "
97305|NCT02012530|"     Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid     Intra-articular Knee Injections for Early Cartilage Defects in the knee.      Study hypothesis: We start with the hypothesis that both treatments are equally effective.      Trial Design: The participating patients will be divided into two groups, each group     receiving either one of the treatment modalities. This study will be randomised. Both     procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The     post-operative rehabilitation process will be the same for both groups.      Trial Participants: All participants will be from patients attending Professor Shetty's     clinic at the Spire Alexandra Hospital.      Planned Sample Size: 50 patients in each group      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3     months following the surgery by visits to the clinic and assessed clinically. The surgical     outcomes will be measured by by IKDC, KOOS and Lysholm scores.      Planned Trial Period: Two to three years      Primary Objective: To establish superiority, if any, of either procedure over the other by     studying pain relief, improvement in function.      Primary Endpoint: At the end of the 2 year follow up for all participating patients.   "
97306|NCT02012517|"     The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing     breast reconstruction who have drains placed for several days after surgery is controversial.     In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment     prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours     cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains.     Patients will sign an informed consent form prior to the surgery and will be randomized to     one of the antibiotic regimens. Patients will be closely followed up to one year after     surgery. The number of surgical site infections according to the NNIS criteria and loss of     breast implants will be compared between the two groups.   "
97307|NCT02012504|"     The primary objective is to evaluate the improvement of antidepressant monotherapy on     depressive and anxiety symptom in Chinese patients who meet Diagnostic and Statistical Manual     of Mental Disorders, Fifth Edition (DSM-5) criteria for the comorbidity of major depressive     disorder (MDD) and generalized anxiety disorder (GAD)   "
97308|NCT02012491|"     The purpose of the study is to compare the effectiveness of combination treatment     (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol     (standard of care) for the management of early pregnancy failure.   "
97334|NCT02012153|"     The general aim of the present study is to test a cell therapy with autologous ex-vivo     expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor     kidney transplant recipients. MSCs will be prepared accordingly to established protocols,     starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4     months before kidney transplant. From these samples, MSCs will be expanded in Good     Manufacturing Practice (GMP) approved facilities and used for the present study in patients     undergoing kidney transplantation.   "
97335|NCT02012140|"     Ticagrelor therapy has been shown to reduce the rates of cardiovascular events and all-cause     mortality compared to clopidogrel therapy in patients with acute coronary syndromes (ACS).     The benefit of this study would be to demonstrate that ticagrelor therapy is associated with     equivalent platelet inhibition irrespective of the disease status in patients undergoing PCI.   "
97336|NCT02012127|"     The purpose of this study is to describe most characteristic association of signs and     symptoms present at the time of acromegaly diagnosis.   "
97309|NCT02012478|"     Despite advances in medical therapy for diabetes, significant numbers of patients fail to     achieve adequate blood glucose control. Diabetic patients who engage in more self-care     behaviors have better glycemic control, as measured by HbA1C. Patient activation, defined     as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the     performance of these self-care behaviors.      There is a growing literature on diabetes behavioral change interventions; however     interventions are often developed and implemented without consideration of patients readiness     to engage in lifestyle changes. Additionally, patient-tailored interventions require     intensive clinical and financial resources, making them difficult to integrate into clinical     practice. Mobile text messaging (SMS) programs have been successfully used to promote smoking     cessation, alcohol cessation, and weight loss in diverse patient populations. SMS     interventions for diabetes have also been developed, but they have been designed primarily to     provide feedback on blood glucose management, rather than to motivate behavioral change. The     few studies that included motivational content as a primary feature, did not tailor their     intervention to a patient's readiness for change or rigorously describe their motivational     intervention, and show limited efficacy.      To address these concerns, we will perform a three-month randomized controlled pilot study to     develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to     patient level of activation for patients with poorly controlled type II diabetes.   "
97310|NCT02012465|"     There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced     elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly     high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior     study by Muthala et al. (unpublished data) found a relationship between insulin requirements     needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In     this pilot study, through an endocrine consult team, a weight-based, steroid dose-based     insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients     requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.   "
97311|NCT02012452|"     The purpose of this study is to examine whether tobacco affects recovery from PTSD. There are     3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects     treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco     compared to those who continue to use and (3) to explore how tobacco use and tobacco     withdrawal symptoms change during PTSD treatment.   "
97312|NCT02012439|"     Chronic pain is a pervasive, serious problem for many individuals with multiple sclerosis     (MS) that is typically inadequately treated by medications alone. There is a critical need to     develop and evaluate innovative psychosocial interventions that have the capacity to     effectively target the multidimensional nature of MS pain. Cognitive Therapy (CT) is one     psychosocial treatment that has been found to be a potentially beneficial treatment for     chronic MS pain. This approach teaches patients to identify and replace unhelpful thoughts     about pain with helpful, more adaptive thoughts. In addition, over the past decade there has     been a steady upsurge of research examining mindfulness meditation-based therapies for the     treatment of medical conditions, including symptoms associated with MS. Mindfulness mediation     involves training the mind to disengage from automatic thinking patterns to mindfully     perceive, in a non-judgmental manner, one's moment-to-moment experiences. This meditation     technique teaches patients to become aware of thoughts, emotions, and physical sensations and     to recognize that these are transient experiences that can be mindfully perceived, accepted     and let go. A promising, more recent trend in treatment development research is the     integration of tradition CT with mindfulness-based meditation, an approach referred to as     Mindfulness-Based Cognitive Therapy (MBCT). To date, we are the only research group that has     adapted and tested a manualized MBCT approach for the treatment of painful medical     conditions. Thus, the proposed pilot randomized controlled trial aims to utilize     state-of-the-art research methodology to evaluate traditional Cognitive Therapy (CT) compared     to an innovative, newly developed Mindfulness-Based Cognitive Therapy (MBCT) protocol for the     treatment of chronic pain in individuals with multiple sclerosis. This study will answer     three primary questions: (1) Do these treatments work to improve chronic pain for individuals     with MS and do these treatment also improve associated symptoms such as depression, fatigue,     and engagement in daily activities?; (2) How do these treatments work in individuals with MS,     i.e., what factors underlie improvement in outcomes during treatment?; and (3) What are the     individual person characteristics that best predict outcome? This will be the first study to     examine MBCT within an MS population. The results will lead to the emergence of a novel, much     needed additional psychosocial treatment option for patients with chronic MS pain.   "
97313|NCT02012426|"     The aim of the current study is to demonstrate that a commercial weight management diet (i.e.     low energy density) influences satiation, hunger and satiety and leads to lower energy intake     during ad-libitum meals and over a full day. We further seek to demonstrate the     sustainability of this effect following 12- week weight loss on the weight management     program.        -  We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater          fullness and reduced desire to eat compared to standard meals.        -  We hypothesise that the commercial weight management program will lead to greater weight          loss compared to control program.        -  We hypothesise that formulated meals (high consumer acceptance) will improve hedonic          control over eating (lower wanting for high fat food)        -  We hypothesise that the commercial weight management program will improve hedonic          control over eating (reduced experience food cravings)   "
97314|NCT02012413|"     PST (pulsed signal therapy) is a unique form of pulsed electromagnetic field therapy (PEMF)     for stimulating healing of damaged structures such as cartilage, bones and soft tissues. The     physical effect of the pulsed electromagnetic field (PEMF) has been focus of research in     various studies, with cartilage being the most studied, and which has demonstrated an     increase in the synthesis of proteoglican and collagen in vitro. This is an randomized,     controlled and double blind clinical trial. The main objective is to evaluate clinical     improvement regarding anterior knee pain after PST intervention in patients with patellar     condropathy.   "
97315|NCT02012400|"     The purpose of this study is to assess the effects of regular exercise on physical fitness,     asthma control, and quality of life among adult asthmatics.   "
97316|NCT02012387|"     To demonstrate the efficacy and safety of Omalizumab in a new indication, that is cholinergic     urticaria.   "
97355|NCT02011880|"     The purpose of this clinical research study is to learn if the clinical effects of combined     Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in     improving the quality of life and shrinking and slowing the growth of the cancer in women     with breast cancer bone metastasis.   "
97457|NCT02010541|"     The first purpose of this study is to is to compare metabolic control of type 1 diabetes     among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose     sensor, and children who use only insulin pump; the investigators will also determine dietary     habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing     illness in the family, in both groups of children.   "
97317|NCT02012374|"     In this study the investigators are examining the effectiveness of intensive speech therapy     in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses     constrained or unconstrained to speech. Both treatments involve massed practice     communicating, using intensive language action therapy 3 hours/day, 5 days/week for two     weeks, followed by six months of a home practice program. One treatment stresses spoken     responses as the preferred expressive modality during intensive therapy. Before and after     treatment, and following the home practice program and a period of no practice, the     investigators will administer several tests and discourse samples to examine changes     associated with the treatments. Participants will also undergo structural and functional MRI     testing at these time points. The investigators will also attempt to quantify the degree to     which improvements following intensive language therapy and home practice correlate with     changes in Quality of Life measures as perceived by both participants with aphasia and their     significant others. It is hypothesized that, whereas both treatments will lead to     improvements in naming practiced words and communicating, outcomes will be enhanced for the     group randomly assigned to the constraint condition. Moreover, performance will be enhanced     on words practiced during the home practice program, including those that were not practiced     during intensive therapy. Improved naming will correlate with modulation of 'signature'     language and attentional networks, whose variability will depend on remaining viable brain     structures. Initial severity and site/extent of lesion should predict patients' ability to     transfer gains in naming to improvements in discourse.   "
97318|NCT02012361|"     The purpose of this study is to determine whether breathing in helium reduces indications of     injury to the skeletal muscle seen in blood tests after knee replacement surgery.      The ability to reduce the risk of skeletal muscle injury may help improve patient safety by     providing protection to the area of the body having its blood supply interrupted during a     particular surgery.   "
97319|NCT02012348|"     This study will recruit up to 10 healthy volunteers. An avirulent strain of S. pyogenes will     be applied to their forearms after washing each of their forearms with different types of     soap, one with an antimicrobial compound, and the other without an antimicrobial compound.     After several hours of incubation, the subject's forearms will be swabbed for bacteria. The     forearms will then be cleansed with antibacterial soap and water followed by 70% ethanol. The     bacterial swabs will be analyzed and compared between the different soaps that were used to     cleanse each digit prior to the application of S. pyogenes. The investigator expects the     number of bacteria surviving on the skin of forearms washed with antimicrobial soaps will be     fewer than with control soap.   "
97320|NCT02012335|"     The purpose of this study is to determine whether combination of ketamine plus     electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.   "
97321|NCT02012322|"     Goal: The investigators propose to test the feasibility of giving the supplement coenzyme Q10     (Q10) improves symptoms and subjective health in an aging population.      Rationale: Direct empirical evidence has supported benefit of Q10 to many symptoms such as     fatigue, muscle pain, and cognition. In addition, Q10 has also been reported to benefit other     symptoms including headaches, sleep disturbances, and breathing problems. This provides a     strong rationale for testing whether Q10 will have similar benefit to these symptoms in an     aging population.      Method: 44 aging subjects will participate. The design is a 9 month, randomized,     double-blind, placebo-controlled crossover study. Each subject will be crossed over between     high dose Q10 (300mg), low dose Q10 (100mg), and placebo, receiving each agent for 3 month     periods. Neither subjects nor investigators will know which substance each subject is     receiving in which phase. Subjects will be randomly assigned to one of six arms.      Assessments: Assessments will include feasibility of study, subjective quality of life,     energy, and metabolic and lipid panels. Analyses will show whether Q10 led to improvements     when compared to placebo; whether higher Q10 doses improved outcomes more than lower doses;     and whether people with certain symptoms or characteristics get more benefit than people with     other symptoms or characteristics.   "
97323|NCT02012296|"     This partially randomized phase I/II trial studies the side effects and best dose of     enzalutamide and mifepristone when given together and to see how well they work in treating     patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth of     prostate cancer cells. Antihormone therapy, such as enzalutamide and mifepristone, may lessen     the amount of androgens made by the body. It is not yet known whether enzalutamide is more     effective with or without mifepristone in treating patients with prostate cancer.   "
97324|NCT02012283|"     This study is being done to determine the differences in liking of vegetables between     individuals based on a variety of variables, and to see if flavoring various vegetables     differently with spices changes the intake of those vegetables.   "
97370|NCT02011685|"     This study will assess the comparative effectiveness, cost-effectiveness and sustainability     of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450     high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood     pressure telemonitoring supplemented with individualized, culturally tailored telephone-based     nurse case management will have greater effects on blood pressure reduction and stroke     recurrence and, while it will be more costly, it will also be more cost-effective than home     blood pressure telemonitoring alone. Results of this study will provide strong empirical     evidence to inform clinical guidelines and practice, which may lead to reductions in stroke     disparities in the United States.   "
97356|NCT02011867|"     The custom made device was produced by Med-El Company. It has a cork like stopper instead     of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of     different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm     (contact space 1.3 mm). It was used in 50 patients with different inner ear malformations.     Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with     initial prototype of the cork electrode had to be revised because of persistent oozing around     the electrode. Another patient had slow extrusion of the electrode most probably due to CSF     (cerebrospinal fluid) pulsation and had to be revised. Both patients had no more CSF fistula.      CSF fistula in inner ear malformations is a serious situation which may lead to recurrent     meningitis. The new cochlear implant electrode with cork stopper looks promising in     preventing the postoperative CSF leak around the electrode.   "
97325|NCT02012270|"     Principles= Prevention of incision hernias by primary closure of mid line laparotomies with     the best-evidenced suture techniques.      Background:      Surgical practice of abdominal wall closure continues to rely largely on tradition rather     than high-quality level I evidence. Incisional hernia after laparotomy for treatment of     abdominal aortic aneurysm (AAA) has a high incidence.      At this moment the best results in a prospective randomised clinical trial considering     incision hernia rates and wound infections, have been reported by the surgeons from the     Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least     4/1 and using many small stitches will be described in the protocol as the Principles     Technique. We want to explore if these results can indeed prevent incision hernias     significantly if implemented with training and tutoring.      Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to     learn the Principles, will be asked to monitor a cohort of AAA patients using their current     sutures and surgical techniques. Some of the vascular surgeons will undergo training and if     wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA     patients will be closed according to the Principles and monitored. The results of these 120     patients will be compared to the control group consisting of patients closed with the     conventional technique by non--‐trained surgeons. Primary endpoint:The incidence of incision     hernias at 12 months will be determined by clinical examination.      Data management and ownership:      The data will be collected on a paper form and will be introduced is a database (SPSS     Statistics, IBM) from which statistical analysis will be made.   "
97326|NCT02012257|"     AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior     alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to     second premolar teeth of one quadrant can be anesthetized. The aim of the present study was     to evaluate the efficacy of AMSA nerve block injection at an anterior and a posterior     positions compared to commonly administrated site.   "
97327|NCT02012244|"     The purpose of this study is to compare postoperative immune function (e.g. NK cell activity)     of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based     anlagesic regimen after laparoscopic colorectal surgery   "
97328|NCT02012231|"     The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics     (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional     objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension     Cohorts (Phase IIa portion).      The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective     tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with     advanced BRAF-mutated cancers.   "
97329|NCT02012218|"     The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects'     subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who     have responded inadequately to preceding adjunctive drug therapy.   "
97330|NCT02012205|"     Background: Persistent nonspecific low back pain (PNSLBP) is one of the most common low back     pains worldwide. Many interventions were tried including wet cupping which is commonly used     for pain conditions in Saudi Arabia and other parts in the world but without solid scientific     evidence.      Aims: This study aims at determining safety and efficacy of wet cupping for treating PNSLBP.      Methods: This is a randomized wait-listed controlled clinical trial. Eligible patients with     history of at least 3 months of PNSLBP will be randomized in to two groups, 45 patients each.     The first group will be given wet-cupping treatment at two acupuncture points of urinary     Bladder (BL) meridians among the BL23, BL24 and BL25, 6 times within 2 weeks. The second     group will serve as a control group. Usual care, including providing brochures for exercise,     general advice for PNSLBP and acetaminophen, will be allowed in both groups. Separate     assessors participated in the outcome assessment. Investigators will use the 0 to100     numerical rating scale (NRS) for pain, the McGill Pain questionnaire for pain intensity (PPI)     and the Oswestry Disability Questionnaire (ODQ), and to assess acetaminophen use and safety     issues.      Expected Results: To provide data on the safety and effectiveness of wet cupping in treating     PNSLBP and open the way for integrative medicine in Saudi Arabia   "
97331|NCT02012192|"     Epithelial ovarian cancer (EOC) is the most lethal gynaecological malignancy causing 41900     deaths annually in Europe. The predominance of aggressive Type II tumours, which are     characterised by a high frequency of p53 mutations, and primary or acquired resistance to     platinum-based chemotherapy profoundly contribute to the high mortality rate. With current     standard therapy the median overall survival of metastatic platinum-resistant (Pt-R) ovarian     cancer patients is only 14 month. There is a pressing need for more effective, innovative     treatment strategies to particularly improve survival in this subgroup of EOC patients. This     is a drug strategy targeting a central driver of tumour aggressiveness and metastatic     ability, namely mutant p53, via an innovative new Hsp90 (heat shock protein 90) inhibition     mechanism. The most advanced, second-generation Hsp90 inhibitor will be used, Ganetespib. The     first part (Phase I) of the GANNET53 trial will test the safety of Ganetespib in a new     combination with standard chemotherapy (Paclitaxel weekly) in Pt-R EOC patients. The second     part (randomised Phase II) will examine the efficacy of Ganetespib in combination with     standard chemotherapy versus standard chemotherapy alone in EOC patients with Pt-R tumours.   "
97332|NCT02012179|"     SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate     the efficacy of a low sodium containing diet on a composite clinical outcome composed of of     all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department     visits. The hypothesis of this study is that patients following a low-sodium containing diet     will have fewer clinical events (fewer hospital readmissions or emergency department visits,     longer survival) than those randomized to Usual Care.   "
97333|NCT02012166|"     This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single     oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on     treatment assignment in young healthy male participants. In Part 2 of this study, sequential     single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment     assignment will be evaluated. The primary hypothesis of the study is that at least one dose     of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo     following the infusion of glucagon, Sandostatine®, and basal insulin.   "
97337|NCT02012114|"     Preventing late onset of Cystinosis such as neurological complications and improving     compliance to cysteamine treatment remain major challenges in management of subjects with     cystinosis.      This study is designed to describe the relationship between compliance of patients with     cystinosis treated with cysteamine and treatment efficacy and to understand the     pathophysiologic mechanism of neurological disorders. Is cysteamine crossing the blood brain     barrier? What is the impact of cystine accumulation in Cerebro Spinal Fluid and Central     Nervous System? Our Primary objective is to study the relationship between compliance of     patients treated with cysteamine and the WBC cystine level.      Secondary, the study will assess relationship between compliance to cysteamine and its     neurological consequences.      The expected duration of the study is 48 months. The enrolment period is 24 months and the     study participation of each subject is 24 months. Eligible participants are male and female     (age > 4 years) with confirmed diagnosis of cystinosis and receiving any oral cysteamine     treatment: Cystagon or RP103.      The compliance under cysteamine is measured using electronic devices, accountability of study     treatment, and information in patients' diary. Specific memory and visuoperceptual tests are     performed at the beginning and at the end of patients'participation. Nuclear Magnetic     Resonance spectroscopy is used to detect possible sites of cystine accumulation in the CNS     and their relationship with compliance to cysteamine treatment. NMRS is also used to     establish a relationship with the neuropsychological status of the subject.      To describe absorption, distribution and elimination of cysteamine, and its metabolic     pathways, and to determine the concentration effect and dose effect relationship, blood     samples are performed at each study visit. A lumbar puncture is also proposed to participants     to verify if cysteamine is crossing the blood brain barrier. New tools are used to compare     metabonomic networks in patients with cystinosis and their controls.   "
97338|NCT02012101|"     The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV),     playing the role as a rescue therapy , are effective in relieving exertional dyspnea in     stable severe COPD patients.   "
97339|NCT02012088|"     The Phase II study proposed here assesses the hypothesis that replacing doxorubicin by     Myocet® in the R-CHOP regimen would yield comparable antitumour efficacy with a lower     cardiotoxicity for first-line treatment in elderly patients with non-localised     DLBCL/Follicular lymphoma grade IIIb   "
97340|NCT02012075|"     The aim of present study is to evaluate the efficacy and safety of Extended-Release     Carvedilol Sulfate versus Sustained-release Metoprolol Succinate in Patients With Mild or     Moderate Chronic Heart Failure.   "
97341|NCT02012062|"     The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute     treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally     advanced NPC. Three hundreds and twenty patients will be recruited into this study.   "
97342|NCT02012049|"     The purpose of this study was to conduct the bioequivalence (biological equivalence of two     preparations of a drug) test in healthy adults with Risperdal OD Tab. 2mg of Janssen Korea     as the investigational drug and Risperdal Quicklet Tab. 2mg as the control drug.   "
97343|NCT02012036|"     The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder     Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients     undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical     practice.   "
97344|NCT02012023|"     Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality     associated with anastomotic leakage (AL) in patients with high risk factors on AL who are     undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate the     efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed to     protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were     compared to those of the loop ileostomy (LI) method.      In fact when we told the patients about the tube ileustomy's effect and risk, almost all the     almost all of my patients like to choose tube ileustomy(I have study this method for long     time and have good expeience, and my patients either choose tube ileostomy directly or let me     do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and     have no control group.   "
97345|NCT02012010|"     This study is to perform a randomized controlled trial of comparing the manual syringe     infusion method with the conventional pump infusion method to clarify if the manual syringe     infusion method really needs less amount of distension medium.   "
97346|NCT02011997|"     This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to     evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus     Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.   "
97347|NCT02011984|"     Non-randomized multicenter post-market study to confirm the long-term safety and     effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent     system for revascularization of de novo stenotic lesions in the superficial femoral artery in     100 compliant patients suitable for stent angioplasty.      The CE-approved device will be used according to its intended use. Beyond the standard of     care no further interventions are scheduled. Therefore, this trial is subject to the     exception to the rule §23b of the German Medical Device Act (MPG), which includes the     national implementation of EC directive 93/42/EEC.   "
97348|NCT02011971|"     Pilot studies in healthy volunteers and in patients with epilepsy to assess the potential     efficacy and safety of different dosages of vinpocetine in improving cognition.   "
97349|NCT02011958|"     The overall objective of this trial is to identify a safe and effective treatment for     visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients.      Patients will receive either Ambisome alone or Ambisome in combination with Miltefosine.      Patients who do not undergo treatment failure will be given a VL prophylactic treatment with     Pentamidine one month after the end of the study treatment.   "
97351|NCT02011932|"     The purpose of this study is to determine the progression of chronic hepatitis C patients     infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease     progression in chronic hepatitis C.   "
97352|NCT02011919|"     This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate     the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device      Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast     fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the     HIFU using the TH-One device   "
97353|NCT02011906|"     The aim of this study is to determine the effects of omega 3 supplementation and its     concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the     expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in     the patients with coronary artery disease   "
97354|NCT02011893|"     The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for     the treatment of chronic intractable pain of the trunk and/or limbs.   "
97357|NCT02011854|"     Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor     of limb function recovery.This research aims to observe the effect and safety of Acupuncture     and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke     Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community     hospital.   "
97358|NCT02011841|"     The aim of this study is to evaluate whether long-term rifaximin administration reduces     spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.   "
97359|NCT02011828|"     The objective of this study is to determine the effects of cholecalciferol treatment on     inflammation and insulin resistance, in patients on hemodialysis that are previously treated     with paricalcitol.      Cholecalciferol is produced by the action of sunlight on a cholesterol precursor in the skin.     This compound is then converted to calcidiol (25(OH) D3) in the liver, whereupon calcidiol is     converted in the kidney to calcitriol (1,25(OH)2D3), the active form of vitamin D. However,     recently it has been shown that deficiency of either calcidiol or calcitriol is associated     with inflammation, insulin resistance and increased mortality in the general population.     Furthermore, when both calcidiol and calcitriol were deficient, the mortality risk was much     higher than the deficiency of either alone. A possible explanation is that some of the     non-renal tissues might critically depend on the endogenous conversion of calcidiol to     calcitriol and not on circulating levels of calcitriol. Thus, low circulating levels of     calcidiol might be associated with tissue level functional calcitriol deficiency despite     adequate circulating levels of calcitriol.      Therefore, the hypothesis is that:        1. In non-diabetic hemodialysis (HD) patients treated with therapeutic doses of          paricalcitol (an analog of calcitriol), calcidiol deficiency is associated with          inflammation and insulin resistance and        2. In calcidiol deficient, non-diabetic HD patients with inflammation and treated with          therapeutic doses of paricalcitol, cholecalciferol will reverse the calcidiol deficiency          and thereby, reduce inflammation and insulin resistance.      Interleulin-6 (IL-6) is thought to play a central role in insulin resistance by     down-regulating glucose transporter-4 messenger RNA. Furthermore, IL-6 levels are     significantly negatively associated with calcidiol levels, therefore will be measured as the     primary outcome.   "
97360|NCT02011815|"     The purpose of this study is to explore the possible association between the circadian     disruption and cancer progression.   "
97361|NCT02011802|"     Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an     acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients     may experience lengthy healing times resulting in considerable morbidity and disruption to a     young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and     at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).      The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to     Alginates that are standardized dressings after pilonidal sinus excision during a period of     75 days. The main objective is to show a difference of 20% of wounds completely healed in 75     days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to     70% of wounds healed with Sorbact TM.   "
97362|NCT02011789|"     Limonoids are compounds found in citrus juices, seeds and peel. Some research shows that they     reduce blood cholesterol and also reduce the incidence of several forms of cancer. Although     these compounds are part of the natural human diet, the dose required to provide health     benefits and the risks associated with the intake of high doses by humans have not been     studied. This study will examine metabolism, safety, lipid-lowering and anti-inflammatory     effects of limonoids. The dose of limonoids in this study is equivalent to that found in six     8 oz glasses of orange juice per day. The investigators hypothesize that limonin glucoside     supplementation will reduce total cholesterol, LDL cholesterol, ratio of LDL and HDL     cholesterol, number of LDL particles, and serum markers of inflammation.   "
97363|NCT02011776|"     The purpose of this study is to evaluate the effectiveness of fluorometholone combined with     sodium hyaluronate eye drops in the treatment of Sjögren syndrome.   "
97364|NCT02011763|"     The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to     confirm the good safety profile of the vaccine.      Primary objective:        -  To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6          months apart, in subjects aged 12 months to 15 years.   "
97365|NCT02011750|"     This is an exploratory study in Egypt that will combine a treatment trial among early course     schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically,     the study will test the provocative results from animal studies indicating an impact of     Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether     exposure to TOX is associated with other cognitive and behavioral changes, as well as changes     in overall social function. We will also explore the relative efficacy of Sodium Valproate     (Depakote, DEP) in improving clinical and overall social function among TOX exposed and     unexposed patients.      Hypotheses        1. At baseline, TOX exposure is associated with increased novelty seeking, clinical          severity, and impaired cognitive and overall social function in patients with SZ.        2. Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in          SZ, particularly among TOX exposed SZ patients.        3. Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP          and TH levels).   "
97366|NCT02011737|"     The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil     75mg once daily for the improving clearance of ureteral or renal stones.   "
97367|NCT02011724|"     The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg     ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful     VLU.   "
97368|NCT02011711|"     Clinical study to determine if hormonal contraceptive use effects cells that fight infection     (i.e., immune cells).   "
97369|NCT02011698|"     this study has the aim to analize the correlation between three different methods of mesh     fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and     recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy   "
97379|NCT02011568|"     This trial is currently a single-center, randomized, double-blind investigator initiated     prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The     plan is to expand the trial shortly as a multi-center project. The patients for this study     will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The     aim of this study is to determine whether neurologic outcomes at six months are improved with     moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH)     following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC     defined as the resumption of sustained perfusing cardiac activity.      The primary outcome will be the proportion of patients experiencing death or a poor     neurologic outcome at six months after out of hospital cardiac arrest.   "
97371|NCT02011672|"     Background: Recent advances in science have established a fundamental role for low grade     chronic inflammation in mediating all stages of most of the non-communicable diseases     associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy     and its components are known to exert beneficial effects on postprandial hyperglycemia. This     study investigates if dairy, normal and enriched, can reduce chronic inflammation via     improvement in glucose regulation.      Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose     regulation and postprandial inflammation with the effect of a standard milk drink, within a     population of overweight, apparently healthy subjects.      Study design: The study is designed as a double-blind randomized placebo-controlled parallel     trial during 7 weeks, during which the test and reference products will be consumed at home.      Main study parameters/endpoints: The difference in absolute change in fasting blood plasma     concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in     postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the     treatment period, between subjects consuming the test and reference product.   "
97372|NCT02011659|"     To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic     patients undergoing laparoscopic surgery after scheduled administration of intravenous     Ramosetron during hospital stays.        -  Randomized controlled arm : Placebo versus Ramosetron injection        -  Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs          after surgery   "
97373|NCT02011646|"     Few obesity prevention programs have produced weight gain prevention effects that persist     over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in     duration, making implementation difficult and costly. The 2010 US Preventative Services Task     Force (USPSTF) recommendations for treating child & adolescent obesity state that programs     should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and     behavioral counseling, and that programs with < 25 hr usually do not produce improvements.     The implication is that, if centers cannot provide this level of service (as most cannot), it     is not worth providing any kind of treatment at all. In extreme exception to this, an     intensive 3-hr non-restrictive obesity prevention program involving participant-driven     healthy lifestyle improvement plans designed to bring caloric intake and output into balance     (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset     relative to alternative interventions and assessment-only controls through 3-yr follow-up. We     propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of     primarily low SES, minority adolescents and young adults who are overweight and report body     dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk     factors for obesity. We will test the hypothesis that participants assigned to the Healthy     Weight vs. control intervention will have significantly lower BMI and % body fat during     follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and     eating disorder symptoms. 300 adolescents and young adults at high risk for future weight     gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder     symptomatology will be randomized to Healthy Weight or weight control educational video.     Participants will complete assessments of BMI, body composition, potential mediators, and     other outcomes at pretest, posttest and 6--mo follow-ups (in yr 1). Thus, to refute the     USPSTF recommendations statement, we propose to show that a 6-hr intervention led by graduate     students can produce significant reductions in risk for both obesity and eating disorders,     suggesting this inexpensive and brief intervention could and should be rolled out nationwide.      Primary Aim: To test the hypothesis that Healthy Weight will significantly reduce increases     in BMI, % body fat, and risk for onset of obesity during follow-up.      Secondary Aim: To test the hypothesis that Healthy Weight will significantly reduce body     dissatisfaction, depressive symptoms, and eating disorder symptoms.      NOTE: THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER   "
97374|NCT02011633|"     To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and     co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state,     respectively.   "
97375|NCT02011620|"     Type 2 diabetes mellitus (DM) is becoming a leading global epidemic. DM affects several     systems in the body. Most of the complications encountered in DM are attributed to     uncontrolled hyperglycemia or poor glycemic control. Hyperglycemic stress tends to damage the     inner lining of the small blood vessels (endothelium). Normally, the endothelium releases a     chemical substance called nitric oxide (NO) which relaxes the blood vessels and also prevents     blockade of these vessels. Therefore damage to the endothelium (endothelial dysfunction)     results in diminished levels of NO which ultimately leads to occlusion of these small blood     vessels (microvascular occlusion). Microvascular occlusion of vessels supplying the eyes,     kidneys and nerves leads to serious complications like diabetic retinopathy, nephropathy and     neuropathy.      Of late, the skeletal system has emerged as another vulnerable target of diabetic     microvascular disease. Patients with DM have an increased risk of developing fractures.     Certain predisposing factors like diabetic neuropathy and visual disturbances (retinopathy     and cataract) increases the likelihood of fractures in DM. More recently, evolving research     has demonstrated NO's prospective role in bone preservation. Earlier studies have also     validated the use of nitrates (donor of NO) in improving bone strength and reducing the risk     of fractures.      So far no study has investigated the effect of nitrates on endothelial function and bone     microarchitecture in patients with diabetes. The investigators therefore propose to     investigate the influence of nitrates on endothelial dysfunction and bone integrity in     patients with type 2 diabetes. 40 patients with type 2 DM will be recruited into the study;     20 patients will receive 20 mg of oral isosorbide mononitrate daily and the other 20 will not     receive the study drug. The investigators hope to demonstrate an improvement in endothelial     function (by measuring skin blood flow) and bone integrity (by measuring markers of bone     formation and bone resorption and bone mineral density - BMD) following 6 months of nitrate     therapy.   "
97376|NCT02011607|"     We propose to collect the data of vital signs and anesthesia medications administered in a     subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be     analyzed to see any relation between the preoperative risk factors, procedure, type of     anesthesia and the airway intervention. The adverse events that will be automatically     recorded and later analyzed will be number of apnea episodes (described as no respiration for     at least 30 seconds) duration of each apnea, number and duration of each desaturation event     (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less     than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway     interventions that will be recorded will be anything other than considered being routine.     This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to     facilitate face mask ventilation. We also propose to monitor their awareness/depth of     sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain     waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between     any unwanted events and the sleep depth.   "
97377|NCT02011594|"     There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is     advantageous for advanced esophageal cancer patients in combination with chemotherapy or     radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to     advanced esophageal cancer patients is not known.   "
97378|NCT02011581|"     The purpose of this research study is to learn more about how our body produces sugar, breaks     down fat for fuel, and makes insulin (the major hormone that controls the production of blood     sugar and fat breakdown) during a 24-hour day and how body fat and muscle are involved in     these processes.   "
97426|NCT02010944|"     This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose     combination (FDC) tablets containing solifenacin succinate and mirabegron with the     co-administration of single entity tablets (SET), at three dose strengths.   "
97427|NCT02010931|"     A retrospective analysis of historical data looking at relapse free survival and overall     survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia     patients.   "
97380|NCT02011542|"     The overall objective is to determine whether Visbiome will improve 1) intestinal symptoms of     Irritable Bowel Syndrome (IBS) and 2) non-intestinal symptoms (fatigue, joint pain, insomnia,     general stiffness and headache) associated with IBS. All of these symptoms are part of the     Gulf War (GW) illness.   "
97381|NCT02011529|"     This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for     patients with schizophrenia. The aim of this innovative mental health center-based team     intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients     with poorly controlled type 2 diabetes. The study will be conducted in two phases over the     2-year grant period.      Phase 1. Development of the adapted TEAMcare intervention and training of team members.      Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients     at Harborview Mental Health Services with schizophrenia and poorly controlled type 2     diabetes. The intervention involves the management of subjects' diabetes, hypertension, and     hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at     supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).      The primary aim of this pilot research grant is to evaluate the feasibility of implementing     this complex intervention, in order to guide the design of a larger scale efficacy study     (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month     follow-up visits for the 40 subjects enrolled in this feasibility trial.   "
97382|NCT02011516|"     Studies show that certain reminders of drug use such as the sight of someone using marijuana,     pictures of blunts, particular moments throughout the day, prompt marijuana users to smoke     marijuana. We are measuring the brain and behavioral responses of marijuana dependent     individuals to these reminders (cues) We will examine brain responses during cue exposure and     determine whether these responses are associated with treatment outcome.      We are testing the hypothesis that the medication baclofen reduces brain responses during     marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is     FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional     magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana     cues. fMRI is a painless technique that takes special pictures of the brain (or other parts     of your body). It does not involve radiation or injections.      Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50%     chance of receiving baclofen. Neither the participant nor study personnel will know whether     participants are receiving baclofen or placebo. Participants will also receive twice weekly     psychosocial treatment with a certified clinician. Twelve weeks of treatment will be followed     by a 12 week follow up.   "
97383|NCT02011503|"     The overall objective of this study is to evaluate the effectiveness of dehydrated human     amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with     venous leg ulcers (VLUs).   "
97384|NCT02011490|"     The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg     intravenous (IV) dose of sugammadex in participants with moderate and severe renal     insufficiency compared to that in participants with normal renal function. The study consists     of two parts. In Part 1, participants with renal insufficiency and healthy participants will     be administered study drug by IV bolus injection into a peripheral vein. In Part 2,     participants with renal insufficiency and healthy participants will be administered study     drug as an IV bolus into a peripheral vein, through an IV catheter connected to IV tubing     with injection port. Subjects who participate in Part 1 of study may be enrolled in Part 2,     which would reduce the overall number of participants enrolled for the study.   "
97385|NCT02011477|"     The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of     neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural     stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.   "
97386|NCT02011464|"     Pain control after knee replacement requires analgesia to both the top (anterior) and bottom     (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion.     The investigators want to to examine if giving Exparel into the posterior portion will give     better pain relief.      Hypothesis: There is no difference in, the use of analgesics or the length and quality of     analgesia and no decrease in the time to be able to accomplish simple to complex knee     movements using Exparel infiltration when compared to controls.   "
97387|NCT02011451|"     The hypothesis is that 95% pure EGCG can protect brain cells in patients with Multiple     Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate     (a chemical that reflects the number of neurons and their metabolism) over one six between     people with MS treated with EGCG at a dose of 400mg twice a day and people with MS treated     with a matching sugar pill.   "
97428|NCT02010918|"     The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg     Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate     Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee     Osteoarthritis.   "
97429|NCT02010905|"     Rationale: The prevalence of adult patients with congenital heart disease (CHD) has steadily     increased over the last decades, due to the advances in cardiac surgery. A large number of     these patients cope with right ventricular (RV) volume or pressure overload, largely caused     by residual lesions after cardiac surgery in childhood. Previous RV overload due to pulmonary     regurgitation in Tetralogy of Fallot (TOF) can lead to RV dysfunction. These findings warrant     close surveillance of RV function, and adequate and evidence-based pharmacological therapy to     reduce both morbidity and mortality in this young patient group. The     renin-angiotensin-aldosterone system (RAAS) is activated in patients with ventricular     failure, irrespective of the effected (left or right) ventricle. Angiotensin converting     enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB's) are drugs which act as     inhibitors of RAAS. Previously, large trials have demonstrated the beneficial effect of     angiotensin converting enzyme (ACE) inhibitors on morbidity and mortality in patients with     acquired left ventricular (LV) dysfunction. ARB's have a similar effect as ACE inhibitors in     patients with acquired LV dysfunction but discontinuation because of side effects such as     cough is less frequent. In TOF patients with RV overload due to pulmonary regurgitation,     pulmonary valve replacement leads to a decrease in RV size and pulmonary regurgitation.     Current guidelines advise empiric use of RAAS inhibitors for right ventricular dysfunction in     adult patients with congenital heart disease. However, the actual effect of RAAS inhibition     on right ventricular dysfunction in adult TOF patients without severe valvular lesions has     not been sufficiently investigated. Therefore, we set-up the proposed study, and hypothesize     that ARB's have a beneficial effect on RV ejection fraction in adult TOF patients with RV     dysfunction without severe valvular lesions.      Objective: to improve RV ejection fraction in adult TOF patients with RV dysfunction without     severe valvular lesions.      Study design: a prospective, multicenter, double-blind, randomized, placebo-controlled trial.     Follow up two years Study population: adult patients with Tetralogy of Fallot with right     ventricular dysfunction, defined as right ventricular ejection fraction < 50% and without     severe valvular lesions Intervention: patients are randomized to receive either losartan 150     mg once daily, or placebo in the same regimen. Main study parameters/endpoints: the primary     endpoint is difference in change in RV ejection fraction, determined by cardiovascular     magnetic resonance imaging (CMR), between the treatment and the control group at two years     follow-up.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: All investigations, except blood analysis, are non-invasive and free of risk.     The burden for the patients mainly consists of the time that is consumed by the visits to the     clinic. At these visits time will be consumed by: history taking and physical investigation     (15 minutes); quality of life score (15 minutes); laboratory tests (6 times venopuncture,     total amount of blood withdrawn approximately 90ml). Cardiopulmonary exercise testing     (1hour), echocardiography (15 minutes) and CMR (45 minutes) are part of regular medical care.     Adverse effects from losartan are usually limited and consist of dizziness due to     hypotension, renal impairment, hyperkalemia and liver impairment. We expect no change or an     increase in RV function in the intervention group compared to the control group over the     two-year follow up period, which would be a great benefit for this young study population.   "
97455|NCT02010567|"     This trial will enroll patients with locally advanced rectal cancer (resectable and     non-resectable).The phase Ib dose escalation portion of trial is designed to determine the     maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies     capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP)     formulation of camptothecin. These results will determine the recommended phase II dose     (RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to evaluate     the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and radiation     therapy prior to surgery.   "
97475|NCT02010307|"     aggressive periodontitis is an inflammatory disease which damage the teeth supporting     structures mostly in young patients. and has genetic basis.      a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this     disease, and found to damage leukocytes by using a specific leukotoxin.      in the research the investigators are aiming to find molecular and immunological basis to     aggressive periodontitis.   "
97476|NCT02010294|"     The main objective of the study is to characterize the virulence factors of SGA and identify     immunological and / or genetic factors predisposing to infections in children hospitalized     with invasive GAS infection.   "
97388|NCT02011438|"     Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and     impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both     social anxiety and depression in adolescents; it includes relational (e.g., social exclusion)     and reputational (e.g., spreading rumors) forms of peer victimization. Currently, there are     no preventive interventions for adolescent SAD. Also, effective preventive interventions for     adolescents have not yet integrated a focus on both social anxiety and depression or targeted     specific peer risk factors. Interventions for depression and for bullying have not addressed     IPV, which is less observable than overt victimization (e.g., threats, physical acts).      Thus, the Peers Emotions and Relationships (PEERS/UTalk) intervention, will take an     integrated approach to reducing risk for SAD and depression by modifying and adapting an     evidence-based intervention for depression, Interpersonal Psychotherapy- Adolescents Skills     Training (IPT-AST), that focuses on improving interpersonal skills and managing conflict. We     will add a) elements of anxiety-based treatments (e.g., exposures) and b) strategies for     handling challenging peer experiences. PEERS/UTalk will have a positive focus and will target     adolescents who report elevated symptoms of social anxiety and/or depression and high levels     of IPV.      Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial:      Aim: Evaluate PEERS/UTalk. We will screen adolescents and conduct a pilot randomized trial of     PEERS (U Talk) versus an Education/Support (ES) condition with up to 60 high-risk     adolescents.      Hypothesis 1: Both PEERS/UTalk and ES conditions will demonstrate: (a) feasibility via rates     of participation and study completion, (b) intervention credibility via adolescents' ratings     of acceptability and satisfaction, and (c) high rates of clinician fidelity to the respective     manuals.      Hypothesis 2: Adolescents randomized to PEERS/UTalk will show improvements in primary     outcomes (less IPV, fewer symptoms of social anxiety and depression, improved clinician     ratings) relative to those in the ES condition.      Hypothesis 3: The benefits of PEERS/UTalk over ES will be apparent on the secondary outcomes     of increased quality of close friendships, increased peer support.      Exploratory Aims: We will examine: (1) the durability and persistence of PEERS/UTalk     intervention effects versus ES on primary outcomes at 6-month follow-up and (2) potential     moderators of response to the PEERS/UTalk intervention, recognizing that there are power     limitations in doing so.   "
97389|NCT02011425|"     Previous studies have shown that contractions of the jaw-closing masseter muscle (MAS) often     occur shortly after respiratory events during sleep in obstructive sleep apnea (OSA)     patients. Although it has been hypothesized that such non-specific motor activations may     contribute to restoration of a compromised upper airway during respiratory events, proper     physiological understanding of MAS contractions in patients with OSA is lacking. MAS     contractions are usually associated with the termination of respiratory events, but these     contractions do not always occur after respiratory events. Therefore, the above-stated     hypothesis that non-specific motor activations of the jaw-closing masseter muscle (MAS) may     contribute to restoration of a compromised upper airway during respiratory events is not     accepted yet. Further, Kato et al. concluded from a recent study that MAS contraction is an     orofacial manifestation of a general motor reaction to arousal occurring during sleep in OSA     patients. This suggests that MAS contraction after a respiratory event is dependent on the     arousal response rather than on the respiratory events per se.   "
97390|NCT02011412|"     The investigators hypothesize that a risk score composed of age, sex, and the components of     commonly ordered laboratory panels will be predictive of mortality in trauma patients, and     will help improve clinicians' ability to make more accurate mortality predictions at the time     of admission.   "
97391|NCT02011399|"     Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for     controlling electronic devices using only brain signals.      The Mu rhythm is a naturally occuring wave produced by the brain. This research project will     determine how to best train subjects to use the Mu rhythm for computer control.   "
97392|NCT02011386|"     The study investigates different criteria for remission based on MRI and circulating     biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with     axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates     factors that affect disease activity, function and participation by use of different     questionnaires.   "
97393|NCT02011373|"     Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but     incurs problems of tolerance of implanted material. As an alternative to stapling and     suturing, which cause vaginal erosion, we present a fixation technique using a sterile     synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will     assess efficacy in terms of 12-month failure of prolapse correction.   "
97394|NCT02011360|"     The overall objective is to explore the mechanisms by which macronutrients regulate food     intake and weight gain in Prader Willi Syndrome (PWS).      Previous studies from the investigators' labs suggest that the increased appetite of PWS may     be triggered or maintained by an increase in the levels of ghrelin, an appetite-stimulating     hormone produced primarily by the stomach. This study will compare the effects of low     carbohydrate diet versus low fat diet on levels of ghrelin, appetite suppressing hormones and     markers of insulin sensitivity in patients with PWS.      The investigators hypothesize that the low carbohydrate diet will suppress plasma active     ghrelin and increase appetite-suppressing hormones to a greater degree and for longer     duration than the low fat diet and will thereby reduce hyperphagia and increase satiety. The     investigators also hypothesize that the low carb diet will improve hormonal and metabolic     markers (fatty acids, amino acids and organic acids) of insulin sensitivity and inflammatory     cytokine profiles of children with PWS.   "
97395|NCT02011347|"     The objective is to evaluate the sparing effect of ketamine on the dose of propofol.   "
97396|NCT02011334|"     This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and     efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease     modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America with     an inadequate response to non-biologic DMARDs.   "
97397|NCT02011321|"     Vasospasm occurs frequently after aneurysmal subarachnoid hemorrhage and can lead to strokes.     The investigators will investigate if infusion of a novel drug, clevidipine, will decrease     vasospasm during the infusion and post infusion period using transcranial doppler monitoring     of patients with subarachnoid hemorrhage and moderate severity vasospasm   "
97398|NCT02011308|"     The purpose of this study is to compare safety and efficacy of Green Light PVP     (Photoselective Vaporisation of the Prostate) compared to TUR-P.   "
97399|NCT02011295|"     The purpose of this study is to determine the clinical efficacy of the application of bone     marrow aspirate concentrate (BMAC) as a supplement to microfracture in the treatment of     osteochondral lesions of the talus (OLTs).   "
97448|NCT02010658|"     The objective of this prospective randomized trial is to ascertain whether the use of a     cognitive aid improves adherence to best published practices for the management of simulated     patients regarding perioperative cardiac evaluation and management.   "
97449|NCT02010645|"     The goal of this clinical research study is to learn if eltrombopag given in combination with     decitabine can help to control advanced MDS. The safety of this study drug combination will     also be studied.   "
97400|NCT02011282|"     We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in     critical care patients, can decrease the impact or severity of the critical illness myopathy     (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect     the incidence density rate of nosocomial pneumonia in the ICU.      Patients will be divided into two groups, Group A and Group B chosen at random. In Group A     conventional physiotherapy will be applied while in Group B, ENMS will also be applied     additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will     be 1 hour, it will be applied before the start of the physiotherapy per day of     hospitalization and for 10 days in each patient.      The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will     undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori     Trichrome will be used to determine the existence or absence of myopathy. In addition the     ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3),     thus achieving a separation of myopathy and neuropathy.      The primary outcome of the study will be the incidence of myopathy in both groups, at day     12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing     this rate by 50% in the intervention group using statistical power equal to 0.80 up to a     level of p <0.05, 12 number of patients will be required in each group.   "
97401|NCT02011269|"     This is a randomized, blinded, multicenter study to assess the safety and treatment effect of     12 weeks of Trichuris suis ova in subjects diagnosed with moderate to severe chronic plaque     psoriasis.   "
97402|NCT02011256|"     The purpose of this study is to determine the frequency of atrial fibrillation in patients     with transient ischemic attack (TIA). Patients suffering TIA will have their heart rhythm     extensively monitored with 72-hour Holter-monitoring and an implantable loop-recorder.     Furthermore, the patients will be examined with echocardiography, coronary calcium-score and     biomarkers with the purpose to predict which subjects at risk for developing atrial     fibrillation.   "
97403|NCT02011243|"     The main objective of this study is to estimate the incidence and prevalence of Internal     Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position     2) strictly greater than 20 ° in a population of advanced-level handball players over a     training season.   "
97404|NCT02011230|"     Pain after tonsillectomy remains a key barrier during the post operative period. The     published return rate to the emergency department for hydration and pain control is     approximately 4%. If we can demonstrate decreased pain or decreased visits to the emergency     department post tonsillectomy, patient experiences will be improved and health care dollars     spent will be decreased. We will attempt to improve hydration status by encouraging     consumption of a novel isotonic hydration solution that is currently commercially available.      Our study hypothesis is that patients provided an isotonic hydration solution and     instructions on avoiding dehydration post operatively will have improved pain control and     decreased emergency department visits.      Improvement in hydration status has the potential of decreasing emergency room visits and     subsequent decrease in spending of healthcare dollars. Additional benefits of post-operative     hydration may include decrease in pain and decrease in post-operative bleeding rates.      A new isotonic hydration solution with an improved flavor profile (Hoist®) has recently     become commercially available. Itis very similar to that of Pedialyte, a commonly used     rehydration solution. Pedialyte was designed for rehydration of infants and small children.     It has a taste that is not acceptable to many adults and older children.      This study will implement the use of Hoist as suitable rehydration solution. This study is     designed to define the relationship between improvement of patient's hydration through     provision of a rehydration solution during the post operative period and decrease in     complications requiring return to the emergency room, including dehydration and bleeding, as     well as improvement in overall pain control.   "
97405|NCT02011217|"     The aim of this study is to contribute to a better understanding of how dietary fibre in rye     affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads     affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We     will also investigate microstructural properties of the crisp breads with microscopy, as well     as to characterize the food products with respect to the content of dietary fibre and certain     bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are     related to changes in insulin and glucose levels, appetite related hormonal signals and     microstructural properties to verify findings from previous studies.   "
97406|NCT02011204|"     This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The     trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular     diseases, and healthy volunteers to see if the EIM device can measure disease in muscle     tissue.   "
97407|NCT02011191|"     Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal     disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in     ESRD and because the vitamin biotin is dialyzable, the investigators examined the     relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of     biotin deficiency in those with and without RLS (Study 1) and to determine the effect of     biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due     to ESRD.   "
97450|NCT02010632|"     The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the     platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid     metabolite between generic and reference clopidogrel products in Thai healthy volunteers   "
97451|NCT02010619|"     To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when     compared to a control group consisting of supportive therapy.   "
97456|NCT02010554|"     Between 15-20% of MS patients decide not to initiate disease modifying therapies after being     diagnosed with MS. For this study, we will develop a telephone-based talk therapy     intervention and then conduct a randomized controlled trial. Patients will be assigned to     either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control     condition. We hypothesize that patients undergoing phone therapy will be more likely to     indicate they are interested in initiating disease modifying medications than patients given     brief education and treatment as usual.   "
97408|NCT02011178|"     Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney     failure,heart disease and premature death. Unfortunately, the best medical therapies     available for DKD today are ultimately unable to prevent its progression, especially in obese     patients.Surgical rerouting of food within the gut with a gastric bypass operation (RYGB),     improves diabetes and some of its complications.      The investigators propose to investigate whether RYGB in combination with best medical     therapy in patients with DKD and obesity prevent further deterioration of kidney function     over a 3 years follow up period.      Study design: This is an international collaboration with leading centres in Sweden and     Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer to     be randomly assigned to receive best medical therapy with RYGB or best medical therapy     without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney     function. Yearly measurements of kidney function will then be done over a period of 3 years     as a primary outcome to determine whether differences in DKD can be detectable. The study     will also examine and compare a) safety of the interventions, b) the health economic impact     on direct healthcare costs and Quality of Life in patients as well as c) the value of a new     marker of DKD in determining which patients are most likely to benefit from surgery.      Overall the study will strengthen the evidence base guiding clinical decisions about the     usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD     in patients with obesity and diabetes.   "
97409|NCT02011165|"     The macular hole formation takes place in the centre of the retina. A closure of the macular     hole is believed to take place if the central retinal area is kept dry in the postoperative     period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the     supine position in the first postoperative days. The investigators use the tennis ball     technique where a tennis ball is fastened in the back of the night shirt in order to help     patients compliance in avoiding the supine sleeping position. The investigators have     developed a positioning measuring device which can measure the extent of supine positioning     time. Patients are to sleep two nights with the positioning measuring device, one night with     a tennis ball in the back of the night shirt and one night without. Hereby the investigators     search new knowledge concerning patients compliance and verification of the tennis ball     technique.   "
97410|NCT02011152|"     The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate     during spinal anesthesia on duration of spinal block and postoperative pain.   "
97411|NCT02011139|"     Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on     the quality of life, functional ability, and mortality, with a prevalence rate as high as     20-25%. However, it is hard to use anti-depressant due to the safety issue, and there has     been little data so far particularly in terms of randomized clinical trials. Here, we     investigate the effect of cognitive-behavioral group therapy for enhancing mental health and     quality of life in patients with ESRD.   "
97412|NCT02011126|"     This phase II trial studies the side effects and how well imetelstat sodium works in treating     younger patients with relapsed or refractory solid tumors. Imetelstat sodium may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
97413|NCT02011113|"     The purpose of this study is to evaluate the efficacy and safety of pomalidomide in     combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.   "
97414|NCT02011100|"     Carnosine is a naturally occurring compound with a potential health benefits. In animal     studies, carnosine supplementation reduces manifestation of chronic civilization diseases,     regulates subclinical inflammation, protein glycation and lipid & glucose metabolism. Our     preliminary data showed the relationship between insulin resistance and carnosine content in     human skeletal muscle. Based on these unique results we plan to perform intervention study     aimed at identifying effects of carnosine on insulin sensitivity and secretion, which might     reduce the development of T2D in obese. Similar metabolic effects of vitamin D3 were     associated with expression of specific miRNAs. Circulating miRNAs related to carnosine action     are unknown. The putative positive effects of carnosine on insulin sensitivity and secretion     in obese patients might have a tremendous impact in prevention of type 2 diabetes.     Identification of miRNAs associated with carnosine action could provide predictors of     successful therapy.   "
97415|NCT02011087|"     This clinical trial studies bioelectrical impedance phase angle in predicting treatment     outcome in patients with extensive stage small cell lung cancer receiving first-line     chemotherapy. Diagnostic procedures, such as bioelectrical impedance analysis, may help     predict a patient's response to treatment for small cell lung cancer.   "
97416|NCT02011074|"     Preoperative anxiety can be detected via structured and standardised screening by the State -     Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The     investigators evaluate the relation of perioperative anxiety and heart rate variability, also     the impact of general anesthesia on the change of heart rate variability.   "
97417|NCT02011061|"     Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed     tomography angiography (CCTA). A novel approach to potentially overcome this limitation is     coronary calcium subtraction.      The primary hypothesis of the study is:      - Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to     conventional CCTA on a per-patient basis   "
97452|NCT02010606|"     The purpose of this study is to test the safety and effects of a special type of a cancer     vaccine called a 'dendritic cell vaccine' in patients with either newly diagnosed or     recurrent glioblastoma. The goal of this dendritic cell vaccine is to activate a patient's     own immune system against their tumor. This study utilizes a patient's own immune-stimulating     dendritic cells that are isolated in a procedure called leukapheresis. In a laboratory, these     dendritic cells are treated in a way that is designed to promote an immune response against     cancer stem cells. Then the dendritic cells are injected under the skin in a series of     vaccinations, with the goal of activating an immune response against cancer stem cells in the     tumor.      To qualify for this study, patients must have very little to no residual tumor visible on a     recent MRI. In addition to the vaccines, patients with newly diagnosed glioblastoma will     receive standard temozolomide chemotherapy and radiation therapy. Patients with recurrent     glioblastoma will not receive any treatment other than the vaccines as long as they are     participating in this study, unless they were previously treated with bevacizumab, in which     case they will be allowed to continue receiving bevacizumab.   "
97418|NCT02011048|"     One of five patients undergoing open abdominal surgery develops an abdominal wall defect     (incisional hernia) as a late complication. A fraction of these are giant hernia with a     fascial defect beyond 10 cm. These patients are physically severely impaired, and surgical     treatment is complex.      Correction of giant incisional hernias including a relatively new and minimally invasive     technique, (endoscopic components separation) offers promising results. This procedure allows     the abdominal muscles to be joined centrally restoring the integrity of the abdominal wall.      The treatment of patients with giant hernia is now centralized at Bispebjerg Hospital     allowing for a joint study between surgeons, pulmonologists, and sports medicine researchers     to define the functional and biophysical outcome from hernia repair. We hypothesize that the     abdominal muscle function is significantly optimized after restoration of the abdominal wall     using this technique, and that muscular function is crucial for the postoperative quality of     life. Moreover, we want to assess whether this operation specifically optimizes the function     and protein synthesis of the abdominal wall muscles, and exerts a beneficial effect on lung     function. Finally, we will investigate if the patients with giant incisional hernia may be     identified by an altered composition of their connective tissue as compared with patients who     do not develop incisional hernia.      This is a prospective study of two patient groups: 1) Patients with a giant incisional hernia     and 2) controls undergoing open surgery on other indications. Assessment is done pre- and     perioperatively and after 1 year including muscular function, lung function, abdominal wall     anatomy as provided by CT-scan, and quality of life. Specified biopsies from muscles and     connective tissue are examined for muscle fiber size/type and structure by various methods,     including electron microscopy and atomic force microscopy. Lung function is monitored by     blood gas concentrations, Chronic Obstructive Pulmonary Disease Assessment Test     questionnaire, and regular spirometry analyses. The studies are carried out by Ph.D. student     Kristian Kiim Jensen, and supervised by professor in surgery Lars Nannestad Jørgensen,     professor in sports medicine Michael Kjær and professor in pulmonary medicine Vibeke Backer.   "
97419|NCT02011035|"     This study is designed to test the safety and efficacy of Colflex, an oral spray created by     Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and     sore throats, as well as dental and oral health changes.   "
97420|NCT02011022|"     * The pharmacokinetics of MTX were assessed with regards to the relevance of several     different patient specific factors in 291 pediatric patients, who were administered with high     dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear     mixed effects modeling.   "
97421|NCT02011009|"     Bacterial resistance to antibiotics is a major public health problem. The epidemiology of     enteric bacteria including E. coli is changing rapidly with the global spread of a resistance     mechanism type beta-lactamase extended spectrum (ESBL), responsible for resistance to almost     all penicillins and cephalosporins. The resistance is up to 75% for Quinolones, 67% for     Cotrimoxazole and 30-50% for Aminoglycosides.      The main phenomena causing this problem are:        -  The selection pressure by antibiotics, in their use in humans or animals        -  The hand transmission via the digestive reservoir (faeces)        -  Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic          support (plasmid)      In this context, we decided to implement a cross-border study to improve and accelerate the     management, diagnosis and treatment of patients with ESBL in close collaboration between     medical and paramedical staff in hospitals, laboratories and private medical offices.      The objective of this study is to standardize diagnostic and therapeutic measures allowing a     better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in     the PACA region and Liguria by providing a tool : The Kit ESBL.      The  ESBL ToolKIT (also translated into Italian) includes:        -  Information on epidemiological data        -  A checklist edited for extra-hospital use (private practitioners, health care units          other than hospitals)        -  A checklist edited for hospital use        -  A leaflet BMR for the patient explaining the problematic as well as hygiene measures        -  Therapeutical protocols for hospital use and extra hospital use        -  An sample letter for the attending physician      The objective of this prospective multicenter cohort study is to evaluate the use of this     kit, and to measure its impact on:        -  The prescription of appropriate antibiotics        -  The measures taken to prevent man to man transmission        -  The quality of information provided to the patient      In this context we are also performing a multicentre prospective interventional cohort of     HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum     ß-lacatamase-producing bacteria) carriers.      We will also try to determine if other sexually transmitted infections associated (syphilis,     gonorrhea and chlamydia) are contributing factors to ESBL carriage.      So far there is no data documented on ESBL-carriage in a population of HIV-positive patients.   "
97422|NCT02010996|"     The great saphenous vein is the most commonly used material in coronary vascular bridging     operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the     incision open groin to ankle. This operation may damage the lymphatic, cause lymph     circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around     hematoma and other a series of symptoms.Based on some studies and our experience that vacuum     assisted closure （VAC）is effective in complex wound failures following Stripping saphenous     vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary     bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC     application on postoperative complications and wound healing after Stripping saphenous vein     in Coronary bypass in comparison to conventional suction drain.   "
97423|NCT02010983|"     Patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell     carcinoma (ESCC). Early diagnosis of ESCC is essential, and detection of an earlier     dysplastic stage is preferred. Endoscopic detection is however difficult and often delayed.     Chromoendoscopy with Lugol dye increases detection rates dysplasia and ESCC to 91-100%. The     aim of this study was therefore to evaluate a screening program using chromoendoscopy with     Lugol to detect dysplasia in patients with idiopathic achalasia.      A second objective is to study the relationship between foodstasis and the development op     dysplasia   "
97424|NCT02010970|"     This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction     study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on     the single-dose PK of AZD3293 and the effects of coadministration of single- and     multiple-dose AZD3293 on the single-dose PK of midazolam. The study will also evaluate the     safety and tolerability of single and multiple oral doses of AZD3293, alone and in     combination with itraconazole, diltiazem, and midazolam in healthy young subjects.AZD3293 is     being developed for the treatment of Alzheimer's disease   "
97425|NCT02010957|"     Adrenal masses are highly prevalent and detected with high frequency by conventional imaging.     Conventional imaging often fails to rule out a malignant lesion. Accordingly, most hormonally     inactive adrenal masses removed by surgery are benign adenomas for which surgical removal is     unnecessary and poses an avoidable risk to the patients. We hypothesize that the combination     of FDG-PET and 123I-Iodometomidate imaging has the potential to noninvasively identify benign     adrenocortical adenomas with high accuracy, thereby avoiding unnecessary surgery. Uptake of     123I-Iodometomidate by the adrenal mass demonstrates the presence of CYP 11B enzymes which     specifically bind metomidate with high avidity establishing the adrenocortical origin of the     lesion, while low uptake of FDG-PET in an adrenocortical lesion establishes its benign nature     and excludes the presence of adrenocortical cancer (ACC). The proposed trial will assess the     sensitivity, specificity, positive and negative predictive value of the combined imaging for     the diagnosis of adrenocortical adenoma. A secondary focus is on the performance of the     combined test for differentiating ACC from non-ACC lesions. We expect that the results of our     trial will help to greatly reduce the need for surgery in hormonally inactive adrenal masses.   "
97430|NCT02010892|"     This is a prospective observational cohort study that will collect data from the point of     referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years).     The data collected will allow estimation of the success of any intervention (in terms of     reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks     associated with the three procedures. Clinical outcomes in the three treatment groups will be     described.      Aims      We aim to answer the following questions:        1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the          risk of aneurysm growth, dissection, rupture, permanent neurological injury or death?          What is the effect on quality of life (QoL)?        2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what          is the risk of growth, dissection, rupture, permanent neurological injury or death?        3. How does QoL change from pre- to post intervention?        4. Can aneurysm or patient related predictors of good/poor treatment outcomes be          determined?        5. What is the most cost-effective strategy in:             1. Patients eligible for either ESG or OSR?             2. Patients eligible for either ESG or best medical therapy (BMT)?             3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?        6. What further research is required? What would be the most important research to pursue?   "
97431|NCT02010879|"     Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses,     there is lack of data on the function of platelets in ductal closure. Information on     functions of platelets in ductal closure may change the known model for ductus arterioses and     may affect the treatment modalities.   "
97432|NCT02010866|"     The purpose of this study is to study whether distressed medical residents, fellows, and     faculty health professionals benefit from completing online an anonymous and interactive     screening of stress, depression, substance use, and suicidal thoughts. The screening and     ability to interact online with a clinician anonymously are hypothesized to increase     willingness to come for counseling in person. Suicide risk factors are expected to be lower     once the distressed medical trainee or faculty member receives treatment.   "
97433|NCT02010853|"     The transient global amnesia, in which the memory disorder is massive, transient and pure,     offers a unique model for exploring episodic memory. Topographic MRI can reveal a focal and     selective lesion located on the CA1 region of the hippocampus better visible between 48h and     72h after onset of the episode.      There is therefore a real dissociation between structural lesions witch are minimal or     non-existent and the massive memory disorder. This suggests that functional impairment goes     far beyond the structural damage in this condition. To our knowledge, no study has been     performed to identify this functional impairment using resting state fMRI.      Thus, investigators wish to study the neural networks involved in memory impairment during     the acute phase of transient global amnesia using resting state imaging. This technique     appears to be modern and adapted to these patients population. Investigators hypothesize that     despite limited structural lesions, a large functional network is impaired compared to that     observed in a group of healthy subjects. investigators believe that the alteration of the     functional network will explain the depth of memory impairment observed.      The main aim of this study will be to identify functional impairment in the patient group vs.     control group during the acute phase of transient global amnesia (TGA) using resting state     imaging.      Patients potentially eligible will be informed during their arrival to the emergency unit. If     the patient is eligible and would like to participate, information will be given. For the     patients willing to participate, inclusion and exclusion criteria will be verified. Two     imaging exams (topographic MRI and resting state fMRI) and neuropsychological assessment will     be performed during three visits.   "
97434|NCT02010840|"     Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation     program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital     relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year     postpartum than those who receive the usual perinatal care.   "
97435|NCT02010827|"     We want to investigate how lack of glucagon suppression during an oral glucose tolerance test     in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.   "
97436|NCT02010814|"     Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS     is characterized by increase levels of testosterone, unwanted hair growth, adiposity,     irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and     cardiovascular diseases. Women with PCOS are reported to have increased levels of stress     hormones, which may be associated with decreased quality of life. Increased testosterone     levels in women may decrease the risk of osteoporosis. The aim of the present study is to     measure levels of stress hormones in urine and describe quality of life using questionnaires.     In addition we aim to characterize body composition and bone architecture using DXA and     ExtremeCT.      As part of the project, a Biobank with fasting blood samples from participants is     established.   "
97454|NCT02010580|"     Subjects will be randomized in a ratio of 1:1 to receive either 60 mg of ospemifene (Osphena,     Shionogi, Florham, NJ) or placebo tablet. Placebo tablets will be identical in appearance and     packaging will be identical for the two pills. The participants will be instructed to take     one tablet in the morning with food for twelve weeks. Basic demographic information will be     obtained on all participants. All women will undergo a pelvic examination, and questionnaires     regarding pelvic floor dysfunction and sexual function before and three months after     treatment. 3-D ultrasound with Doppler blood flow analysis will be performed before the     patient is started on the treatment. 3 months after treatment, the 3-D ultrasound with     Doppler blood flow analysis will be repeated. Four areas will be measured:        1. The urethra in exactly the same section at the same level with the same setups.        2. 3 and 9 O'clock position        3. 6 o'clock position        4. Clitoral blood flow Doppler blood flow will be visualized using the Doppler color mode          of the ultrasound machine and will be applied for the assessment of the vascularity          pattern. Additionally, we will record a film with the use of Color Doppler in a video          file. The transducer will be immobilized at one selected section and record a ten          seconds of film. This film will be further analyzed in special software called Pixel          flux after the examination. Dr. Pawel Wieczorek and Dr. Magdalena Wozniak will read          these deidentified video files in a randomized fashion based on their previous research          experience with similar video interpretations of pelvic color Doppler imaging [8-11].   "
97437|NCT02010801|"     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is     one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in     Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than     8000 people died of this cancer every year in Taiwan. A majority (70%to 85%) of patients     present with advanced or unresectable disease. In contrast, small liver cancers can be cured     with an appreciable frequency. Five-year disease-free survival exceeding 50% has been     reported for surgical resection, and for the inoperable patients who do not have vascular     invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an     alternative curative therapy. However, the main drawback of RFA is its limitation to tumor     size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels,     could not be ablated completely.      Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can     ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor     effect does not result from thermotherapy, so is also not diminished by adjacent vessels.     Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment     for live cancers. The system has received CE mark approval in 2008 and FDA approval in 2010.     However, there is no experience in using IRE fro tumor ablation in Taiwan. In this study, the     investigators will perform intraoperative IRE for the patients with liver cancers who are     scheduled to receive hepatectomy in our hospital, and the investigators will evaluate the     ablate effect of tumors on specimens, and the effect of adjacent vessels. The investigators     will appraisal the clinical feasibility and advantage of the system by this study.   "
97438|NCT02010788|"     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and     efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic     detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by     anticholinergic drugs.   "
97439|NCT02010775|"     This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type     A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).   "
97440|NCT02010762|"     The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection.     Postoperative recurrence of the disease is virtually inevitable and continues to be one of     the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments     to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents appear     promising but are hampered by immunogenicity, side effects and high cost.      Vitamin D has recently received a lot of scientific attention and was found to have strong     anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients     appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in     medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally     missed its endpoint because of lack of power.      The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in     the prevention of postoperative recurrence.   "
97441|NCT02010749|"     The primary objective of the study was to compare the growth parameters of children     approximately 2* years of age, who as infants were randomized to receive either a     lower-protein formula (experimental formula; EF) with 12.8 g/L protein or a standard     formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of     life. The secondary objective was to describe diet and nutrient intake in this cohort of     children. The exploratory objectives were to describe stool microbiota in a subset of this     cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and     minerals) in a second subset of this cohort.      (* The mean age of subjects was 33.0 months due to a delay in the study start-up.)   "
97442|NCT02010736|"     The purpose of this study is to observe the behavior of kinematic variables in children with     spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with     ankle loading.      The children underwent a single treadmill training session with ankle loading. The kinematic     parameters were assessed in three phases: before training (PRE); immediately after training     (POST); and 5 minutes after the end of training (FOLLOW UP).      The investigators hypothesized that the treadmill gait training with additional lower limb     loading would be a disturbance capable of modifying the locomotor strategy of children with     SHCP, by the increase in kinematic parameters in the swing phase of gait.   "
97443|NCT02010723|"     The purpose of this study is to compare two therapeutic procedures in the treatment of     isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and     avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.   "
97444|NCT02010710|"     In women judged to require continuous electronic fetal heart rate monitoring (EFM) during     their labour, does the addition of decision support software to aid the interpretation of the     intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is     not introducing a new form of labour monitoring; it is evaluating the addition of     decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: No     decision-support - CTGs with no additional interpretation (UK standard care), compared with:     Decision-support - CTGs with the decision support software running that will alert     clinicians to the presence of abnormalities in the CTG in real time. How the labour is     managed is entirely up to the recruiting unit and the woman; however the allocation of     decision-support or no decision-support is determined randomly by the Guardian™ system.   "
97445|NCT02010697|"     This study examines whether nonsmokers can be mobilized to help smokers quit. We will test,     via mail campaign, whether targeting nonsmokers can be equally effective in increasing     smokers' quit rate as targeting smokers directly. The hypothesis is that both targeted     interventions will lead to a higher quit rate than a control group, which receives one set of     self-help materials. Each of the targeted intervention groups receives 10 mailings. Smoking     status of all three groups will be measured at 3 and 7 months post randomization.   "
97446|NCT02010684|"     In this project, investigators examine the impact of a mood treatment enhanced diabetes     self-care intervention for depressed, low-income Latino diabetics. The investigators     hypothesize that the mood treatment enhancement will lead to significant improvement in both     diabetes and depression outcomes as compared with the self-care intervention alone.   "
97447|NCT02010671|"     We are surveying women who have had a previous cesarean section at the time of entry into     prenatal care for their next pregnancy about their thoughts related to a trial of labor after     cesarean (TOLAC) or repeat c-section.   "
97458|NCT02010528|"     Parents have an important role in child's diabetes management. Many studies show that     parental psychological stress and family dynamics are associated with parental     diabetes-related distress and treatment outcomes among children and adolescents with type 1     diabetes.      The aim of this study is to analyze diabetes distress (diabetes-related parenting burden and     fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life,     positive and negative affect and adult attachment relationship pattern), family hardiness and     characteristics of children with type 1 diabetes in a sample of mothers and fathers of     children and adolescents with type 1 diabetes of ages up to 18 years.      In this study it is hypothesized that:        1. greater parental fear of hypoglycemia and diabetes-related burden are associated with          lower family hardiness and worse psychological well-being parents and higher HbA1c          levels in children and adolescents with type 1 diabetes;        2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower          psychological well-being comparing to fathers.        3. parents of children and adolescents with type 1diabetes will report greater anxiety,          lower psychological well-being and family hardiness comparing to parents of children          without diabetes.      Standardized and validated questionnaires will be used to determine: parental fear of     hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being,     adult attachment relationship pattern and family hardiness.      The investigators will also measure parent daily involvement in child's diabetes management,     frequency of blood glucose monitoring and parent general satisfaction with glycemic control.     Objective measures such as child's HbA1c level and experience of severe hypoglycemia episode     will also be obtained. These measures will be correlated with other research variables.   "
97459|NCT02010515|"     This prospective single-center study is an observational risk stratification trial in about     250 patients with standard indications for ICD treatment.      Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current     guidelines recommend their use for primary and secondary prevention of sudden cardiac death     (SCD). However, a large number of patients never receive an appropriate therapy from their     device. In contrast, electrical sorm and multiple ICD shocks occur in other patients.      Thus, identification of predictors for survival or ICD shocks is necessary for improved     patient selection and optimized therapeutic strategies.      Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave     alternans (TWA) and Holter ECG including premature ventricular contractions (PVC),     non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and     deceleration capacity, as well as clinical variables is possible, but not implemented in     clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD     for primary or secondary prevention of SCD following current guidelines.      Patients will be prospectively followed and the predictive value of the risk markers     mentioned above to predict all-cause mortality or appropriate ICD shocks will be     investigated.   "
97460|NCT02010502|"     To examine the effects of two forms of beetroot juice supplementation on exercise performance     in trained cyclists.   "
97461|NCT02010489|"     BACKGROUND: Obesity is a global epidemic and Canada has one of the highest obesity rates in     westernized countries. Obesity has many health related complications, including high blood     pressure, high cholesterol, diabetes, sleep apnea and osteoarthritis. Bariatric surgery is     the most effective way of achieving long-term weight loss and treating the complications of     obesity. There is good evidence to support the relationship between physical activity and     weight loss following bariatric surgery. While the period leading up to surgery is considered     an important opportunity for lifestyle modification, evidence to support recommendations for     a supervised preoperative exercise intervention is lacking.      OBJECTIVES: The objective of this study is to measure the short and intermediate-term     benefits of a preoperative exercise intervention on patients awaiting publicly funded     bariatric surgery in Manitoba. The primary outcome will be improvement in general exercise     capacity as measured by change in 6-minute walk test (how far a person can walk on a flat     surface in 6 minutes). Other outcomes will include excess weight loss, change in body     composition, strength testing and irisin bloodwork & muscle biopsy.      HYPOTHESIS: It is hypothesized that preoperative exercise will result in improved exercise     capacity and general fitness in the short and intermediate-term post-bariatric surgery.      METHODS: Patients who are awaiting publicly funded bariatric surgery in Manitoba will be     offered the opportunity to participate in a randomized study between usual preoperative care     (n=35) and usual care plus a supervised exercise program (n=35). Usual care will involve     multidisciplinary evaluation and preoperative counseling with a kinesiologist. In the     intervention group, patients will participate in a 12-week supervised exercise program at the     Reh-fit Centre.      RESULTS: The study will determine the short and intermediate-term benefits of a preoperative     exercise intervention on general fitness and exercise capacity as well as weight loss     post-bariatric surgery. It is an important opportunity for collaboration between a     multidisciplinary health care team and a medically-certified community fitness centre.     Currently there are approximately 200 patients undergoing public bariatric surgery annually     in Manitoba. If this study demonstrates a benefit to preoperative exercise, the results will     be used to support an application to Manitoba Health for routine implementation of a similar     intervention for all patients awaiting publicly funded bariatric surgery. It will also be     used to support an application for a larger multi-institutional study of preoperative     exercise at several Canadian bariatric centres.   "
97462|NCT02010476|"     Type 2 diabetes mellitus has been associated with an about 2-fold increase in risk of     Alzheimer's disease (AD). Patients with AD have been reported to have reduced insulin     sensitivity. It may be hypothesized that, compared to insulin sensitive subjects otherwise     similar in general health and body habitus, insulin resistant subjects are more likely to     have cerebrospinal fluid (CSF) indicators of incipient AD pathology, abnormalities in CSF     peptides related to insulin signaling and glucose homeostasis, and possibly other metabolites     that are associated with a risk of AD. The objective of this study is to examine the relation     of insulin resistance and the concentrations of CSF biomarkers. The results of this study may     be useful in the detection of the subjects who are at risk for cognitive decline and AD.   "
97463|NCT02010463|"     This study aims to support the hypothesis that brain processes underlying reward processing     and impulse control contribute to obesity and to adherence in a new exercise regimen.   "
97464|NCT02010450|"     This study is a pilot study to test the effectiveness of incentive items to increase     compliance of infant safe sleep practices among caregivers.   "
97465|NCT02010437|"     Leaking valves in the veins of the legs causes veins to become large and bloated. These     swollen veins are called varicose veins and are a very common problem, affecting more than     a third of all adults in the UK. Varicose veins reduce people's quality of life by causing     problems such as pain, itching and restless legs. Varicose veins may also damage the skin     over time causing problems such as bleeding, skin colour changes, eczema and even break-down     in the skin which is called an ulcer. Newer, key-hole methods of treating leaky veins have     been developed as an alternative to surgery and can be performed under local anaesthetic with     the patient awake. Rather than cuts in the skin, these minimally invasive techniques are     performed through tiny stab wounds; little larger than needle holes. The varicose vein is     then destroyed from within, usually using heat to burn the inside of the vein. These     procedures are popular; with a rapid recovery and a very high success rate. However these     methods also require the vein to be surrounded by a large volume of dilute local anaesthetic     which can to be slightly painful to administer. A technique called Foam sclerotherapy     involves the injection of a drug which has been mixed into a foam. This goes into the vein     and causes it to stick shut. This procedure is near painless to perform as very few, small     local anaesthetic injections are required; however the chance for a successful treatment     first time are lower and patients may need to return for repeat treatments to successfully     treat the vein.      The aim of this study is to see whether the success rates for this technique can be improved.     One method catheter directed foam sclerotherapy involves the delivery of the foam through a     catheter (a long very thin tube), so that large lengths of vein can be treated through a     single hole. The final method ClariVein again uses a catheter; but this time the catheter     has a small wire on the end which spins around inside the vein; similar to an edge strimmer     in the garden; except it irritates the vein: rather than cutting it. This irritation makes     the vein more susceptible to the drug which can again be applied directly to the vein wall     whilst it is still active. Early results show that this final method is very successful;     however the equipment is more expensive than for the other two.      This study will randomly allocate willing participants with varicose veins to receive one of     these three treatments to see whether the two newer treatments can improve the success rates     and quality of life improvements seen with foam sclerotherapy, whilst also allowing near     painless treatment, without significant complications, at an appropriate cost.   "
97547|NCT02009358|"     The goals of this research were to conduct a mental health intervention study for reducing     self-reported depression and anxiety among migrant workers in a labor-intensive industry in     China and to assess the effectiveness of the integrated mental health interventions aimed at     promoting the mental health of migrant workers in labor-intensive industries in China.   "
97466|NCT02010424|"     In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are     cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of     blastocysts can be observed. This tendency, i.e. improved embryo development in group     culture, has also been demonstrated in other mammalian species, such as mouse, cat and human.     The main reason for this beneficial outcome of group culture has been ascribed to the     presence of autocrine factors, which are factors secreted by preimplantation embryos that act     upon the embryo itself or the neighboring embryos .      Although group culture systems are common in in vitro production systems for animal embryos,     it is rarely done in human settings, where individual follow-up of the embryo during the     whole culture period is of utmost importance. Recently a CE-labelled culture device has been     designed for human embryos, that allow to combine the benefits of both group culture     approaches and individual culture. The WOW dish is commercially available by Primo Vision and     consists of 9 small microwells on the bottom of the plate, so that the embryos can be     cultivated individually in a microwell, but covered by the same drop of culture medium.      In this clinical randomized trial, 158 patients will be included of which half of the     fertilized oocytes will be cultured individually (standard culture system) and half of the     fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture.     The aim of this study is to increase the number of blastocysts suitable for transfer or     cryopreservation by culturing the embryos in WOW dishes.   "
97467|NCT02010411|"     The hypothesis being tested is that inhibition of the enzyme known as elastase in the airways     of patients with cystic fibrosis will help decrease the number of bacteria. Alpha1     antitrypsin, an elastase inhibitor, will be given to patients with cystic fibrosis by aerosol     therapy twice in 1 day and sputum will be collected to measure the density of bacteria   "
97468|NCT02010398|"     The purpose of this study is to determine whether, in patients with multiple sclerosis     presenting with marked asymmetry of strength, training the less-affected limb with a     Cross-Training approach may induce a meaningful transfer of strength with neurophysiological,     functional and clinical correlates, to the contralateral, more-impaired limb.   "
97469|NCT02010385|"     Among all the existing ways to treat obesity (lifestyle, pharmacological), Roux-en-Y gastric     bypass (RYGB) surgery is currently the most effective. It results in long term weight loss     maintenance, significant remission of obesity-related comorbidities and decreased overall     mortality. It also induces changes in gastrointestinal hormones responses, with an increase     of anorexigenic hormones GLP-1, and PYY.      Although successful, the mechanisms for RYGB-induced weight loss are not completely     understood. The RYGB does result in increased satiation, decreased calorie intake and     decreased preferences for sweet and fatty foods. Previous work from our lab has shown using     progressive ratio task (PRT) that RYGB specifically decreases the appetitive behaviour for     sweet and fat stimuli but not for vegetables. The reasons for this change in appetitive     behaviour after the surgery remain unknown. They may be triggered by changes in gut hormones,     conditioned taste aversion (negative post-ingestive effects) or changes in serum bile acids     levels.      This study aims to assess whether RGYB-induced gut hormone changes contribute to the decrease     in appetitive behaviour for sweet and fatty foods observed after the surgery.      This is a double blind controlled study comparing the effect of blocking gut hormones with     somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be     carried out. Appetitive behaviour will be measured using the progressive ratio task.      The investigators hypothesize that blocking the gut hormones in obese patients with RYGB will     increase their appetitive behaviour for sweet-fat candies.   "
97470|NCT02010372|"     The overall purpose of this study is to evaluate the use of features of the New York State     Immunization Information System (NYSIIS) by various types of primary care practices and     determine how best to promote the use of IIS features and functionality. The primary goal is     to promote the use of NYSIIS for immunization quality improvement (QI) in the practice     setting. Customized training sessions will be conducted by study staff to educate practices     on NYSIIS' enhanced features.   "
97471|NCT02010359|"     This study is a clinical trial designed to assess whether fish oil treatments are effective     in the prevention of obesity-related fat tissue (adipose) inflammation. Specifically it     addresses the hypothesis that fish oils treatments will reduce signaling by chemokine     pathways (fractalkine and MCP-1) important in adipose tissue for the recruitment and     activation of certain white blood cells (macrophages). The study is a double-blind     placebo-controlled trial of the fish oil Lovaza from GlaxoSmithKline (omega-3-acid ethyl     esters; a combination of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid     (DHA)) in obese non-diabetic adults, to determine if Lovaza decreases markers of inflammation     and macrophage activation in adipose and blood and understand the mechanism by which fish     oils affect inflammation.   "
97472|NCT02010346|"     The aim of this longitudinal randomized investigation is to determine the long-term effects     of early headgear treatment on craniofacial structures and dental arches, compared to     treatment started later, during the most active growth period in Class II patients.      The aim was further to find out the possible benefits and the burden of early treatment to     the patients and parents of these common malocclusions, when compared to groups treated     later, but with the same methods as much as possible.      The hypothesis is that the timing of treatment has significant effects on orthodontic     treatment total time, the general outcome of the treatment, and the compliance of the     patient.   "
97473|NCT02010333|"     The primary purpose of the study is to evaluate safety and tolerability of a single     application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to     evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric     population.   "
97474|NCT02010320|"     Dosing of tacrolimus is challenging due to the large inter-individual variation in its     pharmacokinetics. The investigators have developed a pharmacokinetics population model that     can be used to estimate individual doses of tacrolimus in renal transplant recipients. The     model will be prospective tested in a randomized clinical trial.      The hypothesis is that the computer model is superior to experienced transplant physicians in     reaching and keeping the patients in the target range of tacrolimus.   "
98199|NCT02000830|"     The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin     (Stanate) on the health, growth, and development of patients who received a single dose of     stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control     (placebo plus PT) group in clinical trial 64,185-204.   "
97477|NCT02010281|"     This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of     magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain     intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with     peripheral neuropathic pain.      The medical device of study: transcranial magnetic stimulator (TMS).   "
97478|NCT02010268|"     This study aims to evaluate a clinico-biological predictive score, associating the faecal     calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.   "
97479|NCT02010255|"     This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus     ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic     genotype 1 or 4 hepatitis C virus (HCV) infection.        -  Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;        -  Cohort B: post-liver transplant, with or without cirrhosis;        -  Group assignment within cohorts is based on severity of liver impairment at screening          (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence          of disease for fibrosing cholestatic hepatitis (FCH) groups)        -  Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.   "
97480|NCT02010242|"     NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic     complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4     inhibitor.      The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients     with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone     system.   "
97481|NCT02010229|"     The purpose of this study is to identify what factors -either individual or related to the     type of management received- influence the maternal outcomes in pregnant women at high risk     for placenta accreta i.e , women with placenta praevia and previous caesarean.      This population-based study conducted in 8 French regions will also provide valid estimation     of the incidence of placenta accreta among all parturients and among at risk women.     Finally, a psychological evaluation of these women up to 1 year after delivery will provide     information on the impact of these conditions on women, beyond somatic complications.   "
97482|NCT02010216|"     This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra     (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8     mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic     therapy, for 12 weeks.   "
97483|NCT02010203|"     This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label,     safety study. Patients will have previously received 3-6 instillations of weekly intravesical     Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose     intradermal (1*10^6 cells) HS-410 monotherapy. In Phase 2, patients will be assigned to     treatment groups based on whether they will receive induction BCG in the typical post-TURBT     window. If the investigator plans to administer BCG, patients will be randomized to one of     three blinded (physician-patient), placebo-controlled groups and receive either intradermal     placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in     combination with induction and maintenance intravesical BCG. If patients will not receive     BCG, they will be enrolled into an open-label, non-randomized group and receive high dose     (1*10^7 cells) intradermal HS-410 monotherapy.   "
97484|NCT02010190|"     This is an observational study that will collect data from adult survivors of childhood     cancer and compare it to data collected from age- and gender-matched controls for the purpose     of assessing vascular risk among cancer survivors.      Advances in cancer therapies have led to increasing numbers of adults previously treated for     a pediatric malignancy, many of whom experience late adverse health-related sequelae and are     at risk for developing chronic conditions related to their prior therapy. The epidemiology of     many end-organ toxicities has been described, yet the pathophysiologic mechanisms of injury     are incompletely understood. One mechanism may be damage to the circulatory system, in     particular the endothelial layer, initiating an inflammatory state leading to dysfunction and     premature atherosclerotic disease. This process may begin and significantly progress in a     sub-clinical nature for many years prior to manifesting as a cardio- or cerebrovascular     event. Using established and novel biomarkers predictive of atherosclerotic disease combined     with unique measurements of vascular function, this study will assess pre-clinical vascular     disease in a population of childhood and adolescent cancer survivors. The goals of this     project are to investigate the effects of cancer therapy on the vascular system and acquire     new knowledge with which to risk-stratify survivors and plan interventional studies to     prevent or reduce premature vascular morbidity and mortality.   "
97485|NCT02010177|"     To assess the ability of baseline clinical parameters and imaging modalities to predict short     and long term left ventricular function and clinical outcome of subjects with low-gradient,     severe aortic stenosis.      To assess the impact of aortic valve replacement as compared to medical therapy on clinical     outcome of patients with low-gradient, severe aortic stenosis.      To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities     on the assessment of AS severity and definition of low gradient severe aortic stenosis.   "
97486|NCT02010164|"     Delaying first childbirth is a progressive trend in the developed societies. Several theories     tried to explain the reproductive aging, in purpose to hasten it. One of the theories include     mitochondrial dysfunction with aging. In this study we will investigate the potential of     treating elderly IVF patients with CoQ10, a mitochondrial stimulator, to improve follicle     cells' properties.   "
97487|NCT02010151|"     The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and     Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac     arrest (OHCA).   "
97488|NCT02010138|"     Eligible patients who were scheduled for surgery for idiopathic macular hole (MH) were     equally randomized to small extent group or large extent group depending on the extent of     internal limiting membrane (ILM) to be removed. The ILM was peeled in round shape with the     radius of either 0.75-disc diameter or 1.5-disc diameter according to the group. The primary     analysis was conducted to identify the difference of functional and anatomical outcomes     between the two groups. Subsequent analysis was performed to reveal the relationship between     the functional and anatomical outcomes.   "
97489|NCT02010125|"     This study will evaluate the bio-mechanical and biochemical abnormalities in acute     ACL-injured knees over time. Data will be collected through advanced quantitative MR imaging,     functional testing, and bio-specimen collection. Researchers will collect this data from the     time of baseline visit, which is within 28 days of injury, through the temporal sequence of     post-operative or post-injury recovery and return to activity.      The hypotheses for this study are (1) that T1ρ and T2 will be significantly elevated in the     lateral side of ACL-injured knees immediately after injury (indicating damage caused by     initial injury), and will not fully recover at 6-month, 1-year follow ups; (2) that T1ρ and     T2 will be significantly elevated in the medial side of ACL-injured knees at 1-year     follow-up; and (3) that differences in the bio-marker expression patterns can be correlated     with the initial MRI findings, which would provide information regarding the full spectrum of     intra-articular pathology and the subsequent clinical outcomes.   "
97490|NCT02010112|"     A new method of breath collection for testing for Helicobacter Pylori infection has been     developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy     results to prove its accuracy.   "
97491|NCT02010099|"     Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product     (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).      Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control     product usage: according to label, 3-4 times daily application to rectal region.      At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge,     swelling, itching, discomfort and painkiller usage.      Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing     treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are     examined by study physician who assesses hemorrhoid severity.   "
97492|NCT02010086|"     The study is a randomized controlled trial to examine the efficacy of individual cognitive     behavioral therapy (CBT) relative to a standard community treatment, in youngsters with     autism spectrum disorder (ASD). The individual CBT program has been tailored over the last     five years to the clinical needs of high-functioning youth with ASD.   "
97493|NCT02010073|"     We wish to prospectively assess the burden of, management and therapeutic approaches to, and     outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the     winter months in both the northern and southern hemispheres. We wish to specifically examine     the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic     respiratory failure.      Why?      The purpose of this study is to provide new and current data on the disease burden of acute     hypoxemic respiratory failure and ARDS. It will answer the following questions:        -  What is the frequency and disease burden of acute hypoxaemic respiratory failure in          winter?        -  What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory          support?        -  What is the incidence of ARDS based on the Berlin definition within this patient cohort?        -  What is the mortality from ARDS within this cohort, and how does this vary based on ARDS          severity?        -  What is the natural history of ARDS?        -  What are the key patterns of therapeutic resource utilization, particularly approaches          to sustain gas exchange, in these patients?      When?      The study is performed over a 4 week period between February 1st and March 31st 2014 in the     Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.      What data is required?      A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory     failure requiring ventilatory support, with a more detailed dataset collected on patients     diagnosed with ARDS.   "
97494|NCT02010060|"     This study will determine the health benefits of combining exercise training and increasing     the amount of physical activity in daily life on the fat around the abdomen, weight, fitness     and sensitivity to insulin. Volunteers will participate in one of three groups for 6 months:     1) a control group, 2) exercise training only, or 3) exercise training and increasing     physical activity outside of training. The exercise training will follow the public health     recommendations for exercise (150 minutes/week of moderate exercise). The group increasing     physical activity along with exercise training will be asked to increase physical activity in     their daily life (up to 3,000 step/day above their current levels through the use of step     counters), and meetings focused on behavior modification. The investigators hypothesize that     combining aerobic training and additional physical activity after training will have the most     profound reduction on waist circumference and body composition.   "
97495|NCT02010047|"     The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung     cancers. Testing for this gene is important because there are drugs known as ALK inhibitors     that have been shown to significantly delay the progression of ALK-mutated lung cancers.     There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy     tissue. One method involves making slides and staining them to detect the ALK protein. This     is called immunohistochemistry. Another method called fluorescence in situ     hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung     cancer. Although both these tests are widely used to test for ALK gene abnormalities, the     techniques may not always find the ALK gene mutation because they are not sensitive enough or     not enough cancer cells are present in the lung biopsy.      This study is being performed to determine if a technique called quantitation polymerase     chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung     cancer biopsy tissue.   "
97496|NCT02010034|"     This study is being done to determine if an investigational study drug called Omegaven can     help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN     is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are     unable to drink fluid or eat food by mouth.   "
97558|NCT02009215|"     We propose to evaluate the community-level impact of intermittent preventive treatment (IPT)     for malaria in schoolchildren on clinical outcomes and malaria transmission, using a     cluster-randomised design in Jinja, Uganda. Dihydroartemisinin-piperaquine (DP) will be     administered to schoolchildren monthly for up to six rounds of treatment during one school     year. Outcomes will be measured using surveys of communities, schoolchildren, and mosquito     vectors. Our proposal also includes health service research to evaluate the potential     feasibility of taking the programme to scale, which will guide future research and     implementation of the intervention, and help shape policies in Uganda and elsewhere in     Africa.   "
97497|NCT02010021|"     Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is     prevents cells from producing estrogens. This should assist with the slowing of growth of     tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction     pathway.      The objectives of this study will look at the differences between the cellular destruction     pathway before and after letrozole use, and the differences in the cellular destruction     pathway in participants that have received letrozole versus those who did not. The study will     also look at a gene in all participants called Ki67. This gene is associated with the rate of     tumor cell growth. The study will measure the levels of Ki67 and compare them to the amount     of activation of the cellular destruction pathway.      Participants in this study will have undergone a diagnostic biopsy of their breast tissue.      In order to meet these objectives, one group of participants (Arm A) will not receive     letrozole. Tissue leftover from their diagnostic biopsy will be treated with RAD001     (Everolimus) in the laboratory and the effects of this drug on the cellular destruction     pathway will be studied.      The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum     of 21 days. They will have a second tumor sample taken as part of their surgical procedure     completed to remove the tumor tissue. Any differences in the cellular destruction pathway     before and after exposure to letrozole will be measured.   "
97498|NCT02010008|"     ¡Fortaleza Latina! is a multi-level randomized trial to increase participation in mammography     screening among Latinas who seek care at a community health center in Western Washington.      In partnership with the partnering community health center, we have obtained lists of women     patients aged 42 to 74 years old who had not had a mammogram in the last two years and     resided within defined radii of the four clinics. Baseline and one year follow-up surveys     will be obtained by in person home interview. Participants are randomized within clinic to     intervention or comparison group. The intervention consist of two motivational interviewing     sessions, one in person in the home, and one telephone follow-up. The study hypothesis is     that a higher proportion of participants in the motivational interviewing arm will obtain a     screening mammogram within the study period than those in the comparison arm.   "
97499|NCT02009995|"     BACKGROUND Resistance exercise training with free weights or weight machines clearly improves     glucose (sugar) control in type 2 diabetes (T2D). However, many patients with T2D would     prefer not to attend an exercise facility, for reasons of cost and/or convenience.     Coinvestigator Jonathon Fowles has developed and pilot-tested a home-based exercise program     for people with T2D using resistance bands. However, the effects of resistance-bands training     (on glucose control in T2D have not been evaluated in a high-quality randomized trial.      SPECIFIC AIMS To determine the effects of six months of progressive home-based resistance     bands training (RBT) versus no RBT in people with T2D on blood glucose control (HbA1c,     primary outcome), waist circumference, heart disease risk factors, and quality of life.      METHODS A total of 100 T2D participants will be randomized to 2 arms: home-based RBT (RBT-H)     or aerobic training only (ATO). Both groups will accumulate 150 minutes per week of aerobic     exercise such as walking. The resistance exercise workout includes 12 exercises, targeting     all major muscle groups. RBT-H subjects will complete most exercise at home with periodic     supervision.      SIGNIFICANCE The global burden of type 2 diabetes is increasing, and complications of the     illness occur primarily in those whose glucose control is fair or poor. If exercise training     with resistance bands improves glucose control, it could be beneficial to the large numbers     of patients who cannot travel to a gym or cannot afford gym membership. If resistance     exercise is then adopted by more patients, it is likely that the morbidity associated with     type 2 diabetes will be decreased. This is particularly true if such training also improves     quality of life, and more people are thus inclined to continue exercising in the long term.   "
97500|NCT02009982|"     The purpose of this study is to evaluate the effectiveness of cardioneuroablation for the     treatment of neurocardiogenic syncope (NCS), also known as vaso-vagal syncope. Syncope is a     general term for passing out spells and neurocardiogenic syncope is a specific form of     passing out spells caused by sudden drops in heart rate or blood pressure. Although the     specific mechanisms of NCS are not well understood, it is believed that some people are prone     to developing passing out spells in specific situations such as standing up for a long period     of time, pain or nausea. In these situations, the body reacts with a paradoxical reflex which     leads to a drop in blood pressure and heart rate and causes passing out. Certain types of     medications are used to treat NCS including beta-blockers, midodrine and florinef, among     others. However, none of these medications are particularly effective at preventing passing     out spells and many people continue to have episodes despite trying different medications.      Cardioneuroablation is a new form of treatment for NCS. The term ablation means using a wire     to make small electrical burns in the heart. Ablation has been used for many years to treat     other electrical disturbances in the heart but the use of ablation to treat NCS is a new     application. The goal of cardioneuroablation is to identify areas within the heart which are     believed to initiate the reflex which triggers the drop in heart rate and blood pressure that     leads to passing out. In preliminary studies, it has been suggested that cardioneuroablation     may be significantly more effective than medications at preventing passing out spells for     people with NCS.      Hypothesis: Cardioneuroablation of vagal inputs in the left atrium may serve as an effective     treatment modality for the prevention of NCS by blunting the initial trigger of the cascade     that leads to symptoms and syncope.   "
97501|NCT02009969|"     The purpose of this study is to compare abdominal weight gain and fat distribution to changes     in brain morphology in people taking antipsychotic medications.   "
97502|NCT02009956|"     To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent     System and the DESyne BD Novolimus Eluting Coronary Stent System   "
97513|NCT02009813|"     Obesity is an epidemic in Western society and is the biggest risk factor for insulin     resistance and type 2 diabetes. The investigators have recently shown that exposure to     hyperbaric oxygen (HBO) leads to an increase insulin sensitivity in males ubjects and that     this improvement can be measured in all men, not just those with diabetes. The aim of this     study is to investigate the time course of this effect and explore the mechanisms involved.     The investigators suspect that insulin sensitivity as measured by     hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour     hyperbaric oxygen exposure, and that the improvement will be measurable in females as well as     males.   "
97514|NCT02009800|"     This randomised clinical trial aims to determine whether an immunization schedule comprising     two doses of Gardasil administered six months apart is non-inferior to a schedule comprising     three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18     infections that persist for at least six months, up to ten years after the initial     vaccination.      The study hypothesis is that the two-dose schedule would offer similar protection as that of     a three-dose schedule against persistent HPV-16/18 infections.   "
97515|NCT02009787|"     The investigators planned to research the effect of vitamin D supplementation as an adjuvant     therapy for patients with hypercholesterolemia.   "
97503|NCT02009943|"     The inflammatory response associated with surgical critical illness rapidly induces a     functional iron deficiency, characterized by hypoferremia, decreased transferrin saturation     (TSAT), hyperferritinemia, and iron-deficient erythropoiesis (IDE). This functional iron     deficiency both contributes to intensive care unit (ICU) anemia and increases the packed red     blood cell (pRBCs) transfusion requirement.      The goals of iron supplementation of critically ill surgical patients are to reverse the     serum iron debt, eliminate IDE, improve anemia, and decrease pRBCs transfusions. Issues     surrounding iron supplementation of this patient population include formulation, dose, route     of administration, and mitigation of the complications of iron overload, including infection.      The investigators first randomized clinical trial (RCT) of iron supplementation of critically     ill surgical patients compared enteral ferrous sulfate 325 mg thrice daily to placebo     (NCT00450177). Although a significant reduction in pRBCs transfusion requirement for the iron     group was observed, low injury severity, intolerance of enteral medications, and a     predominance of traumatic brain injury limited generalizability. In a second multicenter RCT,     the investigators compared intravenous iron sucrose 100 mg thrice weekly to placebo among     critically ill trauma patients (NCT01180894). Iron supplementation at this dose increased the     TSAT only marginally (and not above the normal range) and increased the serum ferritin     concentration significantly; however, there was no effect on IDE, anemia, or pRBCs     transfusion requirement. In no instance did iron supplementation increase the risk of     infection, despite a relatively high incidence of marked hyperferritinemia (serum ferritin     concentration > 1,000 ng/mL) in the iron group.      The severity of both the serum and bone marrow iron debts observed in these trials led us to     investigate alternative dosing schemes that deliver larger quantities of bioavailable iron     safely. Ferric carboxymaltose (FCM) is a novel iron-containing complex that allows for the     administration of a large replenishment dose of iron (up to 750 mg) over a short infusion     period. Several pharmacodynamic properties of FCM render it appealing for use in the     treatment of functional iron deficiency associated with surgical critical illness, including     a short infusion time, a controlled, sustained delivery of iron to target tissues over a     relatively long period of time (up to one week), and minimal hypersensitivity reactions.     Increased efficacy and comparable safety have been reported for FCM as compared to iron     sucrose for treatment of outpatients with iron-deficiency anemia. There are currently no data     regarding the efficacy of FCM for the indication of functional iron deficiency associated     with surgical critical illness.      The aim of the current pilot trial is to compare two novel dosing schemes for treatment of     function iron deficiency in surgical ICU patients, both of which involve delivery of a larger     total dose of iron as compared to both NCT00450177 and NCT01180894. The investigators     hypothesize that iron supplementation with FCM, as compared to both iron sucrose and placebo,     is more effective and equally safe for replacing the serum iron debt.   "
97504|NCT02009930|"     Hypothesis: Enlisted military members with 10 or more years of service and at least one     cardiovascular risk factor will demonstrate a higher risk of future cardiac events as     assessed by coronary artery calcium scoring than the risk calculated by the Framingham Risk     Score.   "
97505|NCT02009917|"     Protein is a major structural component of all cells in the body. The nutritional importance     of protein is because of their amino acids. 9 are called essential and 11 are called     non-essential, based on whether we need to get them from diet. This classification is based     on studies done using older techniques. Recent studies suggest that these so called     non-essential amino acids play important roles in our body's health. For the first time, this     proposal defines an experimental design to examine non- essential amino acid/nitrogen     requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO)     technique.      The objective of the current study is to examine the application of IAAO technique to     determine the non-essential amino acid/nitrogen requirement in adult humans.   "
97506|NCT02009904|"     Phenylketonuria(PKU)is a rare condition caused by the body's inability to properly breakdown     an amino acid called phenylalanine(PHE), due to a missing enzyme, phenylalanine     hydroxylase(PAH). When the enzyme is missing and/or not functioning properly, it increases     the level of PHE in the body. High levels of PHE can cause severe brain damage or nerve     damage unless the children are on a strict low PHE diet. A low PHE diet restricts the intake     of protein rich foods and can pose a significant burden to both the patient and the family.      Investigators at the University of British Columbia and British Columbia Children's Hospital     will examine the phenylalanine metabolism in children with PKU using a simple breath test.      Patients (5-18y) receiving standard clinical care at the BC Children's Hospital's Biochemical     Diseases Clinic will be enrolled.The study will be conducted twice on each patient. Baseline     measurements will be performed at the beginning of each study for each patient.The Physician     in charge will then prescribe the standard dose of sapropterin dihydrochloride (Kuvan®)     (20mg/kg/d) or otherwise as deemed appropriate by the physician-in-charge. The test will be     repeated a week (minimum) after the beginning of treatment with the prescribed dose.      The investigators propose that children who are responsive to sapropterin dihydrochloride     (Kuvan®) will have increased 13CO2 in breath after treatment, and those who do not respond     will have no change in the 13CO2 in the breath before and after treatment.      As a comparison to the experimental group, age and gender matched healthy controls will also     be studied. The test in healthy controls will be performed once without any intervention, and     is only used as a comparative value.   "
97507|NCT02009891|"     To determine in women undergoing IVF who are at high risk of multiple births (>35%), as     calculated by the application of a predictive model - IVFsingleTM, if single embryo transfer     will lead to both comparable clinical pregnancy rate (CPR) and other secondary outcomes such     as live birth rate (LBR) and cumulative live birth rate (cLBR) in comparison to DET while     reducing the incidence of multiple births (a secondary outcome measure).   "
97508|NCT02009878|"     This is a study to evaluate how the body handles and metabolizes (PK) the various doses of     the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the     content of salt in blood and urine   "
97509|NCT02009865|"     This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy     and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects     with severe hypertriglyceridemia. The study consists of an approximately 8-week screening     period that includes a diet and lifestyle stabilization and washout period and a 12-week     treatment period.   "
97510|NCT02009852|"     The Role of microRNA-29b in the Oral Squamous Cell Carcinoma   "
97511|NCT02009839|"     The main aim of this study is to examine the effectiveness of a web-based CBT protocol     (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The     researchers hypothesized that the Meeky Mouse program would be associated with higher     frequency of speaking behaviors, lower levels of anxiety, greater improvements in     clinician-rated severity of mental illness, and higher clinician-rated improvement scores at     post-treatment.   "
97582|NCT02008903|"     The overall goal of this study is to develop a novel minimally invasive device, the     Esophageal String Test (EST) to monitor esophageal inflammation during treatment of the rare     disease Eosinophilic Esophagitis (EoE) in a safe and efficacious manner.      This study is broken down into 2 specific aims:      Specific Aim 1: Identify the EoE Biomarker Panel (EBP) that will improve the sensitivity and     specificity of the EST for documenting esophageal inflammation in a 1-hour time point.      Specific Aim 2: Validate the ability of the EST EBP to monitor therapeutic efficacy in a     1-hour sampling time.      Funding Source - FDA OOPD   "
97516|NCT02009774|"     Adenomas and hyperplastic polyps are polypoid lesion and may occur at any location in the     colon. At the present moment, all polyps should be resected endoscopically, although only     adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This     approach enables the conduction of microscopic investigations of the lesions. By today, only     the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps.     Some studies have investigated the value of the socalled optical biopsy method. Optical     biopsy means the visual assessment of the polyp and the determination of a diagnosis solely     on behalf of optical criteria. This method is conducted in real time during colonoscopy. If     it can be shown, that endoscopist using optical biopsy are able to predict histopathological     diagnoses of colonic polyps sufficiently this would possibly lead to simplification of     diagnostic procedures. For instance, it would be conceivable to resect hyperplastic polyps     and small adenomas and discard them without further assessment by a pathologist.     Gastroenterological societies demand for a 90 percent accordance between diagnoses set by     endoscopists and pathologists as a prerequisite for the implementation of the optical biopsy     method.      In this study we want to proof that the use of a new narrow-band imaging (NBI) tool (Exera     III, Olmpus) is capable to rise accuracy of optically ascertained diagnoses of colonic     polyps. NBI is a light filter tool which can be activated by pressing a button at the     endoscope. NBI function leads to an endoscopic picture which appears blue and enables     endoscopists to better assess surface structures and vascular patterns.      In a prospective randomised multicenter setting we plan to conduct colonoscopy in 380     patients. Half of the patients will be examined without use of NBI (control arm). In these     cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool.     If polyps are detected in patients belonging to the intervention arm NBI will be used and     optical diagnosis will be determined using the NICE (NBI International Colorectal Endoscopic)     classification. All polyps will be resected and send to pathology for further microscopic     assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in     both groups. Our hypothesis is, that by using the new NBI tool accuracy (accordance between     optical and histopathological diagnosis) can be increased from 78% to 90%.   "
97517|NCT02009761|"     BI 655064 will be administered subcutaneously once weekly in patients with immune     thrombocytopenic purpura (ITP) for up to 12 weeks.   "
97518|NCT02009748|"     Previous studies suggested that vitamin D deficiency is highly prevalent in cirrhotic     patients and is related to the degree of liver dysfunction as well as mortality. In     gastrointestinal disorders, vitamin D absorption can be highly reduced.      We herein aim to investigate the efficacy of oral vitamin D supplementation in cirrhotic     patients with vitamin D insufficiency.   "
97519|NCT02009735|"     To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza     Virus detection, the investigators conduct a prospective clinical study. In comparison with     results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators     evaluate the performance of virosensor , including reproducibility, sensitivity, specificity,     and cross-reaction. The potential factors which may interfere with the results would be     investigated. With such technique, the investigators hope to make early diagnosis and give     Enterovirus 71 and Influenza Virus patients early treatment to reduce the complications and     case-fatality rate.   "
97520|NCT02009722|"     Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve     pain control after cesarean delivery. In this study, the investigators are going to determine     the doses of each of those medicines that provides optimal pain control to women undergoing     cesarean delivery while limiting side effects related to those medicines. The investigators     hypothesize that the doses of hydromorphone and morphine that provide optimal pain control     without significant side effects will be 100 micrograms and 150 micrograms, respectively. The     investigators further hypothesize that at each respective optimal dose, side effects will be     less in the hydromorphone group.   "
97521|NCT02009709|"     The primary objective of this study is to determine the effectiveness and safety of corneal     collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.   "
97522|NCT02009696|"     The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the     ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.   "
97523|NCT02009683|"     In this study the investigators aim to build a model to predict the maintenance of sinus     rhythm (SR) after successful direct current cardioversion (DCC) incorporating standard     predictors such as echocardiographic parameters, clinical parameter and 12-lead ECG     parameters and new parameters, including 17-lead ECG, Oesophageal-ECG and single nucleotide     polymorphisms (SNPs). Using this novel integrated prediction model will help in the     identification of patients who will maintain SR after cardioversion. Another innovative     aspect of our study is the use of daily rhythm monitoring using a versatile device     (MyDiagnostick®). The clinical impact this study will have is that it helps the cardiologist     to make a patient tailored strategy in the treatment of AF as advocated by the guidelines and     to prevent exposing patients not likely to maintain SR to the potentially harmful side-effect     of a rhythm-control strategy.      Primary objectives To show that a model incorporating the novel predictors 17-lead ECG,     Oesophageal-ECG and SNPs is superior to existing models in predicting maintenance of sinus     rhythm after successful DCC in patients with persistent AF.      Secondary objectives To assess the predictive value of new predictors (the Oesophageal-ECG,     17-lead ECG and SNPs) for maintenance of SR after successful DCC separately.      To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs)     for time to recurrence of AF.      To assess the predictive value of predictors with respect to complete failure of     cardioversion.      To assess the predictive value of predictors with respect to cardiovascular morbidity.      Hypothesis The investigators hypothesise that a model incorporating the novel predictors the     17-leads ECG, Oesophageal-ECG and SNPs performs significantly better than existing models     using only clinical, echocardiographic and ECG parameters on a standard 12-lead ECG in     predicting maintenance of SR after successful DCC. In addition the investigators hypothesise     that Oesophageal-ECG is the best single predictor for maintenance of SR after successful DCC.   "
97524|NCT02009670|"     In this placebo controlled, double-blind, randomized crossover study the investigators will     investigate in overweight/obese healthy male volunteers whether inulin administration will     increase intestinal SCFA production, thereby investigating whether this will lead to acute     metabolic effects.   "
97525|NCT02009644|"     The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the     Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic     Aneurysms (AAA).   "
97526|NCT02009631|"     This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac     repolarization in patients with solid tumors who's cancer has recurred or is no longer     responding to current treatment.   "
97527|NCT02009618|"     To evaluate the efficacy of Rifaximin therapy started prior to completion of advanced     examination procedure (before colonoscopy) of patients pre-diagnosed with irritable bowel     syndrome, and implement it into clinical practice.   "
97528|NCT02009605|"     This study is designed to evaluate the efficacy of icotinib at routine dose in previously     treated non/light-smoking patients with advanced squamous cell lung cancer.   "
97529|NCT02009592|"     Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it     encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually     leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life style,     type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease progression.     Research on the role of gut-liver axis in the pathogenesis of NAFLD has been slowly     accumulating over the past few years. Endotoxemia resulting from intestinal bacterial     overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve     as a potential therapeutic target in NASH. In this regard, we have aimed to test the efficacy     of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects in relation     to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis that     Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and     partial alleviate from NAFLD/NASH.   "
97530|NCT02009579|"     Indication:      Treatment of subjects with advanced (FIGO stage IVB) or recurrent cervical cancer, prior     radiochemotherapy or neo-adjuvant chemotherapy is allowed.      Study design:      This is a phase II randomized, double blind and placebo controlled trial evaluating the     efficacy of Nintedanib/placebo in combination with the standard carboplatin and paclitaxel     followed by Nintedanib/placebo maintenance in the treatment of patients with advanced or     recurrent cervical cancer.      A total of 120 patients will be randomized between the experimental and control arm in a 1:1     ratio. Randomization will be stratified for 1previous chemotherapy for metastatic disease     (yes/no) and 2disease status (Stage IVB primary versus recurrent disease).      Experimental arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel     (175 mg/m2) and Nintedanib 200 mg BID followed by Nintedanib maintenance until progression or     for a total maximum duration of 120 weeks.      Control arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175     mg/m2) and placebo 200 mg BID followed by placebo maintenance until progression or for a     total maximum duration of 120 weeks.      Subjects without evidence of disease progression after completion or discontinuation of the     study treatment will be followed until radiographic disease progression, withdrawal of     consent or death.   "
97531|NCT02009566|"     Surgical sponges can be accidentally left inside patient's bodies. We are working on special     tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the     surgeons forget to remove a sponge from a patient, they'll be able to detect these special     tags in an x-ray.   "
97532|NCT02009553|"     Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is     that pre-procedural explanation note about the test may reduce the anxiety level of the     patients.   "
97533|NCT02009540|"     Overactive Bladder (OAB) is a chronic condition caused by instability of the detrusor or     bladder muscle, which gives rise to symptoms of urinary urgency and often urinary     incontinence. Idiopathic Detrusor Overactivity (IDO) is a subset of OAB where the cause for     the bladder muscle instability is unknown.      OAB is usually treated by conservative measures or with oral medications eg.     anticholinergics. Injection of onabotulinum toxin A (onaBoNT-A) into the bladder wall is     licenced in the treatment of refractory IDO where oral medications fail. The injected toxin     paralyses the bladder by blocking the ability of certain (motor) nerves to communicate with     the bladder muscle. As these nerves are mainly concentrated in what is known as the body of     the bladder this is traditionally where the injections are given.      In addition to its action on motor nerves, onaBoNT-A also affects sensory nerve pathways.     Recent studies show that IDO is caused by both motor and sensory nerve dysfunction, therefore     injecting the trigone, a part of the bladder where sensory nerves are particularly dense,     may be of clinical benefit. Three studies comparing trigone versus trigone-sparing injection     of botulinum toxin in the treatment of IDO have been carried out. One of these indicated a     significant benefit in targeting the trigone and the other two did not show any difference.      Our study aims to examine if injection of onaBoNT-A into the trigone alone will provide     symptom and functional improvement in patients with IDO by comparing peritrigonal injection     of onaBoNT-A with the traditional method of injection which spares the trigone.   "
97534|NCT02009527|"     The present project is designed to test the hypothesis that arginase contributes to     endothelial dysfunction induced by ischemia-reperfusion in patients with coronary artery     disease.   "
97535|NCT02009514|"     The purpose of this study is to investigate differences in glycemia        -  during the whole hemodialysis day and the whole freeday        -  during hemodialysis, during the evening and the night after hemodialysis and at the same          time intervals during the freeday in an unselected type 2 diabetic patient group using          both glucose-containing and glucose-free dialysate.   "
97536|NCT02009501|"     This study would like to determine if using negative pressure wound therapy with an     instillation of .125% Dakins is more effective than using negative pressure wound therapy     alone on biofilm removal, disruption and elimination in chronically infected lower extremity     wounds.   "
97537|NCT02009488|"     The purpose of this study is to assess changes from baseline in insulin sensitivity, hepatic     fat content and beta cell function after approximately 24-25 weeks of treatment with     canagliflozin compared to placebo in participants with type 2 diabetes mellitus (T2DM) with     inadequate glycemic (blood sugar) control on metformin monotherapy or on combination therapy     with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor.   "
97538|NCT02009475|"     The aim of the present study is to evaluate differential lactate removal kinetics in heart     failure patients that are trained according to 2 different exercise protocols:      (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT)   "
97539|NCT02009462|"     Artefill is an injectable facial filler device that is currently approved by the FDA for the     correction of nasolabial folds. This study seeks to examine the use of Artefill in the     treatment of HIV associated facial lipoatrophy. Facial lipoatrophy (facial fat loss) related     to HIV is a stigmatizing condition characterized by loss of facial fat, most notably in the     cheeks and temples.   "
97540|NCT02009449|"     This is a first-in-human, open-label, dose escalation study to evaluate the safety and     tolerability of AM0010 in patients with advanced solid tumors, dosed daily subcutaneously as     a monotherapy or in combination with chemotherapy or immunotherapy.   "
97541|NCT02009436|"     This pilot phase I trial studies the side effects and best dose of azacitidine in treating     patients with lung cancer that is stage IV or has returned after previous treatments     (recurrent). Azacitidine is a drug used in chemotherapy that may stop tumor cells from     growing or spreading by activating genes that help prevent cancer growth, called tumor     suppressor genes. As people age, these genes are silenced by a chemical reaction that occurs     naturally in the body, or by exposure to environmental factors such as smoking. Azacitidine     may help reverse this process and restore the function of the tumor suppressor genes.     Delivering azacitidine directly into the lungs by inhalation may work better in treating lung     cancer.   "
97542|NCT02009423|"     The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to placebo.   "
97543|NCT02009410|"     maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion     of fat, sugars and proteins) in diabetes type II   "
97548|NCT02009345|"     Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder     associated with premature CAD. In Canada, the burden of disease is estimated to be     approximately 83,500 patients. The goal of this initiative is to create a registry of     subjects with FH across Canada. Rare diseases of lipoprotein metabolism will also be     included. Using a hub and spoke model, the registry will be extended in various communities     to link primary care physicians with provincial academic centers. The registry will include     clinical, biochemical and demographic information. Specimens (plasma/serum and DNA) will be     collected for biobanking. We propose a three-tier registry: local, provincial and     Canada-wide, which will be completely anonymized. The registry will be made available for     clinicians to manage patient care, identify relatives for screening and treatment (cascade     screening), to provide advice to general practitioners and to support collaborative studies     in biomedical, clinical, health outcomes and health economics research. The data extracted     for the provincial portion of the database will allow administrative database research that     will provide important information to key stakeholders and permit allocation of resources. It     will also allow a sound and uniform rationale for the use of novel therapeutic agents and     provide expert advice to regulatory agencies. At the Canadian level, the database will allow     clinicians and researchers to determine the burden of disease and the long-term effects of     treatment. Through the creation of a Canada-wide network of academic clinics, integrating     lipid specialists, endocrinologists and cardiologists, the Canadian FH registry will lead to     significant benefits for FH patients, clinicians and researchers, biopharmaceutical industry     and government.   "
97549|NCT02009332|"     Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety     and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer   "
97550|NCT02009319|"     The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of     mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain     ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue     diagnosis as a gold standard.   "
97551|NCT02009306|"     When patients are dying they become unable to take oral medication and if they develop     symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of     medication. If they are at home this requires that a District Nurse is called and it can take     a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful time for     the patient and family.      There are 2 drug preparations which could potentially be given by family members in the home:      Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms     this would give much quicker symptom control for patients and might mean the District Nurse     visit was not needed.      In advance of a community based randomised trial of these modes of administration, it is     important to assess the feasibility of such an approach in terms of carer acceptability and     patient tolerability as well as determine appropriate sample sizes and sampling methods.     There are 2 work packages which would help assess feasibility of a community trial:        1. An open label randomised controlled trial comparing the use of PecFent with or without          Epistatus versus standard subcutaneous breakthrough medication for the management of          breakthrough pain (with or without agitation) in dying hospice patients who either          remain in the hospice or go home.        2. A qualitative interview study to capture the thoughts of relatives of these patients          about the use of these preparations.   "
97552|NCT02009293|"     In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients     with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice.     The hypothesis is that Pirfenidone will decrease cough and increase quality of life.   "
97553|NCT02009280|"     The aim of this study is to investigate whether propofol based total intravenous anesthesia     reduces incidence of acute kidney injury following the lung transplantation under     extracorporeal membrane oxygenation   "
97554|NCT02009267|"     A retrospective chart review study analyzing the benefits of patient controlled analgesia,     thoracic epidural analgesia, and paravertebral nerve block catheters in patients having     surgical repair of pectus excavatum using the Nuss procedure.   "
97555|NCT02009254|"     Potato is one of the world's most popular foods and is widely accepted as a staple food. The     objective of this study is to determine the effect of consuming instant mashed potatoes with     and without fat on glycemic response, subjective appetite and food intake. It is hypothesized     that mashed potato with added fat (as it is usually consumed) will result in lower glycaemic     response and subjective appetite, and reduced subsequent food intake.   "
97556|NCT02009241|"     Lymphangioleiomyomatosis (LAM) is a rare disease in which reduced exercise capacity is     frequently present. The mechanisms applied are airflow obstruction, abnormal diffusion     capacity and dynamic hyperinflation (DH).      Pulmonary rehabilitation (PR) has proved benefit in improving exercise tolerance, dyspnea,     and quality of life in chronic obstructive pulmonary disease. There are no studies evaluating     the impact of PR in patients with LAM.      The hypothesis under study is that PR determine improvement in exercise capacity, dyspnea,     quality of life, muscle force, functional limitation and DH in these patients.   "
97557|NCT02009228|"     Minimally invasive surgery has become the standard treatment for many gynecologic disease     processes. In the last decade, numerous studies have demonstrated that laparoscopic     approaches to various gynecologic oncology conditions-particularly for early-stage     endometrial and cervical cancers as well as select pelvic masses-is feasible and results in     shorter hospital stays, improved quality of life and comparable surgical and oncologic     outcomes to abdominal staging.For instance, the typical gynecologic robotic surgical     procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an     even less invasive alternative to conventional laparoscopy surgery has been developed:     laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port     laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive     surgery while minimizing the potential morbidity associated with multiple incisions.     Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate     that the techniques are feasible provided that both optimal surgical technical expertise with     advanced skills and optimal instrumentation are available. Recently, several publication     showed the single port laparoscopic surgery is feasibility in gynecologic surgery including     oophorectomy, cystecomty, and myomecomty. To our knowledge, the sample size of recent     publication about single port surgery including cystectomy and myomecomty is small.     Furthermore, these studies lack the comparison of single port and convectional laparoscopic     surgery. Base on our recent study demonstrated that either the single-port or the     conventional approach can be used for LAVH, but the single-port LAVH technique yielded less     postoperative pain (Chen et al., Obestet Gynecol, 2011). The purpose of this study was to     assess the feasibility of single port laparoscopic surgery in the treatment of benign     gynecologic disease.   "
97559|NCT02009202|"     Colonoscopy is a routinely performed examination of children and adolescents in the     diagnostic process of inflammatory bowel disease (IBD). It is necessary that the bowel is     clean so the colonoscopy can be optimally performed. The cleansing of the bowel by means of     laxatives prior to the examination is, however, considered difficult by many children.     Getting smaller children to cooperate and to drink a substantial volume of laxative fluid     prior to the examination can be particularly difficult. There are several possible cleansing     procedures and combinations of procedures for the cleansing of the colon, for example by     means of polyethylene glycol and sodium picosulphate, which are the two most commonly used     methods. Cleansing by means of polyethylene glycol can, due to the necessary intake of a     substantial quantity of fluid, be particularly frustrating for patients. Often the only way     to carry out the preparation is with the insertion of a nasogastric tube, which can cause     discomfort for some children. Cleansing the colon by means of sodium picosulphate, which     involves an intake of a small quantity of fluid, has been suggested to be a good sufficient     method resulting with a satisfactory result in terms of bowel cleanliness. However, studies     have so far encompassed only a smaller number of children and further studies are needed to     confirm that there is no difference between the two methods in terms of resultant bowel     cleanliness.      The purpose of this randomized controlled study is to compare preparation by means of     polyethylene glycol and preparation with sodium picosulphate prior to colonoscopy in     children.      One hundred children scheduled for colonoscopy in southern Sweden will be randomized into     either patient group 1 (for preparation with polyethylene glycol) or patient group 2 (for     preparation with sodium picosulphate). For the random sampling, data-driven selection will be     implemented. A CONSORT Flowchart (2012) will be encompassed by the study. To assess the     cleanliness of the intestinal tract (and volume of fluid in the intestine), the Ottawa Scale     will be used (Rostom & Jolicoeur, 2009). All colonoscopy examinations will be performed by     the same paediatric gastroenterologist, to whom no information about which preparation method     was used by each child will be disclosed. Furthermore, the gastroenterologist will, meet with     the children first after the investigation has been completed. All information regarding the     investigation will be given to the patient by the admitting physician. During the colonoscopy     the gastroenterologist will evaluate the intestinal cleanliness and submit the reports in     sealed coded envelopes to the nurse in charge of the patient.   "
97560|NCT02009189|"     Taurolidine alone or in combination with citrate have been proposed for locking the catheter     to reduce the number of catheter infections. As there is not enough evidence to give     recommendations in this regard, the study tested the hipothesis that taurolidine improves the     outcome of long term paretneral nutrition.   "
97561|NCT02009176|"     The purpose of this study is to compare short-term and long-term efficacy of two surgical     methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical     method from the pathology and cytology.   "
97562|NCT02009163|"     To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and     placebo, as measured by the number of binge days (defined as days during which at least 1     binge episode occurs) per week as assessed by clinical interview based on subject diary and     Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by     the end of the Open-label Treatment Phase.   "
97563|NCT02009150|"     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology     using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D     metabolic maps and based on sophisticated machine learning technology, provides objective     risk assessment for the presence of malignant tumor. The procedure is non-invasive,     comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional     MIRA is unaffected by breast density and is therefore ideal for evaluating patients with     mammographically dense breasts.      The purpose of this clinical study is to assess the ability of this novel technology to     detect clinically occult breast cancer in a cohort of women that are at high risk for breast     cancer.      We hypothesize that the combination of screening mammography and metabolic screening (3D     MIRA) will result in significantly higher breast cancer detection rates.   "
97564|NCT02009137|"     Expected Total Number of Subjects        -  Level of significance, alfa 0.05        -  Power 0.80        -  Mean difference between two treatments is assumed 35        -  Standard Deviation is assumed 35.        -  Follow-up loss is assumed 20%        -  N=34(each group:17)   "
97565|NCT02009124|"     The purpose of this study is to study the effect of stem cell therapy on common symptoms in     patients with spinal cord injury.   "
97566|NCT02009111|"     Couple CARE for Parents is a couple-focused intervention that addresses interpersonal     processes within relationships and promotes relationship and parenting skills among couples     with a newborn. Couple CARE for Parents uses an approach developed in Australia that was     designed to be fairly easy and cost-effective to disseminate widely (i.e., home-visitation     and video- and telephone-assisted skills training). It has demonstrated efficacy for     significantly enhancing couples' relationship satisfaction in three Australian randomized     trials.      Arresting the normal decline of satisfaction of new parents to near-clinical levels is     noteworthy because relationship dissatisfaction is one of the strongest predictors of partner     physical assault. Managing relationship conflict is critical to the health and well-being of     both parents and their children. Given the high prevalence of partner physical and emotional     aggression (a precursor to the more serious form labeled intimate partner violence [IPV])     in new parents) among perinatal parents, the need for efficacious prevention services is     acute.      This randomized, controlled trial will test if couples with a newborn who receive Couple CARE     for Parents report significantly less IPV than control couples who do not receive the     program. This is a prevention trial. No couple will report ever having experienced IPV. All     couples will have three empirically documented risk factors for the development of IPV: youth     (each couple will have at least one partner under 30 years of age), parenting a newborn, and     psychological aggression in the past year.      The project has the following aims: (1) Determine the outcomes of Couple CARE for Parents.     The investigators hypothesize that, among other positive outcomes, couples who receive Couple     CARE for Parents, compared with those who do not, will report at follow-up (a) less IPV; and     (b) less partner physical and emotional aggression. (2) Identify factors that may contribute     to reduction in IPV and in physical and emotional aggression (e.g., communication skills,     conflict behaviors, parenting expectations, , quality of adult attachment, partner     attributions, child abuse potential, family income, marital status, parenting stress, infant     difficultness).   "
97577|NCT02008968|"     Several studies showed that hyperuricemia is an independent risk factor for development of     diabetes mellitus. However none of the previous studies have investigated the effect of     lowering serum uric acid levels on insulin resistance of which is also named as prediabetes.     With this background in mind, we aimed to test the effect of lowering serum uric acid level     with allopurinol on insulin resistance.   "
97578|NCT02008955|"     The lysine requirement of elderly female subjects 65-75 years old will be 40-45 mg/kg/day.   "
97579|NCT02008942|"     This study will determine if aspirin from PL2200, an investigational product, gets into the     blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to     prevent blood clots as effectively as enteric coated aspirin, when administered to patients     with diabetes   "
97580|NCT02008929|"     To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative     liver resection on the patient with advanced HCC who has high risk of recurrence.   "
97583|NCT02008890|"     Was to demonstrate superiority of secukinumab compared to placebo in patients with moderate     to severe chronic palmoplantar pustular psoriasis with respect to the palmoplantar pustulosis     Psoriasis Area and Severity Index 75 response rate   "
97651|NCT02008006|"     The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine,     etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for     first and second chemosensitive relapses in patients with follicular lymphoma (World Health     Organisation (WHO) grade 1, 2, 3a).   "
97567|NCT02009098|"     Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum     infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS     infections is 7-10%. The most common infections are endometritis, Urinary tract infections     (UTI) and wound infections (WI).      Prophylactic antibiotics are effective in preventing postoperative infections and national     guidelines recommend that antibiotics should be administered as a single dose immediately     before surgical incision. CS is an exception to this pre-incision administration approach.     National guidelines recommend administration of antibiotics after umbilical cord clamping to     avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic     prophylaxis for CS suggest that prophylactic antibiotics administered before incision     compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two     Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on     the baby and on late infection in the mother.      This study is a double-blinded randomized controlled trial with a concurrent Health Economic     Assessment. The study will examine the effect of change in timing of prophylactic antibiotics     on the rate of post-CS infections (endometritis, UTI and WI). The study will be performed at     the obstetric departments at Odense University Hospital (OUH), Hvidovre Hospital (HH) and     Hospital South West Jutland (HSWJ) in collaboration with the Department of Clinical     Microbiology, OUH, to ensure that the most appropriate antibiotic regime is used.     Furthermore, collaboration with a neonatologist will ensure appropriate assessment of     neonatal outcome.      The investigators plan to enroll the first patient at OUH February 2013. HH and HSWJ will     follow with a couple of months delay. The inclusion period is scheduled to last until the     investigators have 2844 participants, who have answered the questionnaire. The investigators     expect to complete the inclusion period in October 2014 (last patient last visit, LPLV).     Microbiological analyzes and data processing is expected to be completed one year after the     LPLV. The study population is all women delivering a child by CS during the project period,     at Department of Gynaecology and Obstetrics of OUH, HH and HSWJ.      Objective: Investigate whether and by how much antibiotics administered 15-60 minutes before     incision versus after umbilical cord clamping reduces the rate of postpartum infections in a     Danish population of women undergoing CS.      Hypothesis: Antibiotics administered pre-incision will result in fewer postoperative     infections than antibiotics administered after the umbilical cord is cut.      Hypothesis: Antibiotics administered before incision are cost-effective, compared to     administration after umbilical cord clamping, measured by post-CS infection and as cost per     Quality Adjusted Life Year (QALY).   "
97568|NCT02009085|"     In this study a fluorescent contrast dye is applied to a suspicious skin lesion.      Images are acquired and processed. The information is used to develop a prediction model for     the presence of malignant transformation in the skin.   "
97569|NCT02009072|"     Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical     management techniques and high rate of post-operative recurrence. The investigators aim was     to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in     management of primary pterygium.   "
97570|NCT02009059|"     In pre-hospital care, there are few non-invasive thermometers that are proved both robust and     accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based     thermometer on patients undergoing thoracic surgery in deep hypothermia.   "
97571|NCT02009046|"     This study examines the effectiveness of the Sexuality Education Initiative (SEI), a     comprehensive, multi-component, rights-based sexuality education program developed and     implemented by Planned Parenthood Los Angeles for high school students. The primary goal of     the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high     schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive,     rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy     component, (3) a parent education component, and (4) clinical services linkages. It is     hypothesized that the 12-session classroom curriculum is more effective than a 3-session     control sex education curriculum. It is also hypothesized that the full SEI package (all four     components) is more effective than the control condition (control curriculum and clinical     services only).   "
97572|NCT02009033|"     The purpose of this study is to investigate the effect of thin fluid with starch versus thin     fluid without starch on coagulation in elective surgery when the patient is normovolæmic     during operation.   "
97573|NCT02009020|"     Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse     pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med     2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz     technique, a non-invasive measurement device is now available commercially. In this study,     the reference technique based on arterial measurement and a respiratory variation monitor     (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a     clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure     and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1:     307-10)   "
97574|NCT02009007|"     Liberal fluid administration is one of risk factors of developing acute lung injury (ALI) in     thoracic surgery. Therefore, the investigators try to restrain fluid administration, and in     the case of intraoperative hypotension, the investigators often administer vasoactive agents     or inotropes. One lung ventilation (OLV) which is routinely employed for thoracic surgery     decrease arterial oxygenation and oxygen delivery to brain can be also decreased. In this     study, the investigators compared dopamine and phenylephrine in respect to maintaining     cerebral oxygen saturation in major thoracic surgery. The investigators hypothesis is that     dopamine is better than phenylephrine to maintain cerebral oxygen saturation in thoracic     surgery.   "
97575|NCT02008994|"     Genes are the basic instruction book for the cells that make up our bodies and are made out     of DNA. Many research studies are done to find the best possible way to treat patients with     cancer. Recently there has been a great deal of interest in developing new anticancer agents     that are more targeted to a patient's individual genetic information, as well as diseases     caused by defects in a person's genes.      Identification of precisely which treatments to use against a specific patient's tumor is     challenging. In this study, four cutting-edge technologies will be used to identify genomic     (information we get from DNA and RNA) and proteomic (information we get from proteins)     targets for the treatment of your tumor. These four tests will be used together to gather     information about your tumor giving doctors and scientists a better understanding of the     structure of your tumor and what the best treatment or combination of treatments may be for     you. The therapy you receive to treat your tumor will be based on your medical history,     previous treatments for your disease if applicable, current state of health, and the findings     from these four tests. The therapy you ultimately receive will be selected by your doctor in     consultation with a panel of experts in cancer and cancer genomics (the Treatment Selection     Committee).   "
97576|NCT02008981|"     This is a research study on the effect of some commonly used blood activating herbal     products on platelet function and coagulation profile, ie whether it causes an increase in     bleeding tendency, either used alone or in combination with Aspirin which is a commonly used     anti-platelet drug.   "
97581|NCT02008916|"     The purpose of this study is to generate 16-week efficacy data, as well as up to 3-year     efficacy, safety and tolerability data in subjects with active AS despite current or previous     NSAID, DMARD and/or anti-TNF therapy.   "
97584|NCT02008877|"     Phase 1: To assess the safety, tolerability, and maximum tolerated dose (MTD)/ recommended     dose of ganetespib when administered in combination with sirolimus in patients with     refractory or relapsed sarcomas including unresectable or metastatic sporadic or     neurofibromatosis type 1 (NF1) associated MPNST. Phase I enrollment has been closed.      Phase 2: To determine the clinical benefit of ganetespib in combination with sirolimus for     patients with unresectable or metastatic sporadic or NF1 associated MPNST.   "
97585|NCT02008864|"     Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in     patients with end stage renal disease. It affect up to 90 percent of patients with end stage     renal disease. Several hypotheses have been postulated for the possible underlying etiology,     but none is conclusive. Aside from kidney transplantation, which is only definitive     treatment, therapeutic approaches have largely been empirical, and no firm evident‐base     treatments are available. The main goal of therapy remains to minimize severity of pruritus.     In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this     study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a     double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may     attenuate uremic pruritus by decreasing serum IL‐2, IFN-γ and TNF‐α.   "
97586|NCT02008851|"     The purpose of this study is to determine if selected renal cells, obtained by biopsy from a     patient with chronic kidney disease (CKD) and Type 2 Diabetes (i.e., autologous cells) can be     safely implanted back into the patient.   "
97587|NCT02008838|"     To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile     in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot     study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or     placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups     will be advised to follow an energy balanced diet and physical activity recommendations.     Parameters related to metabolic syndrome and insulin resistance will be measured every 7     weeks during the study course.   "
97588|NCT02008825|"     We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG     will:        1. enhance delineation of the stomach anatomy and the surgeon's appreciation of the extent          of gastric volume to be removed;        2. increase the safety profile of the patient (i.e., reduce the likelihood of accidental          stapling of the orogastric tube or bougie);        3. reduce the incidence of OR contamination/infection transmission;        4. streamline OR workflow, resulting in reduced OR time; and        5. ensure consistent and reproducible staple lines.   "
97589|NCT02008812|"     To develop a real-time diagnostic technique with Ad sensor for Adenovirus detection, the     investigators conduct a prospective clinical study. In comparison with results from direct     sequencing of Adenovirus, the investigators evaluate the performance of Ad sensor , including     reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which     may interfere with the results would be investigated. With such technique, the investigators     hope to make early diagnosis and give Adenovirus patients early treatment to reduce the     complications and case-fatality rate.   "
97590|NCT02008799|"     Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately     1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy reveals     that these men have Sertoli cell-only pattern, maturation arrest, or hypospermatogenesis.     Until recently, it was assumed that men with non-obstructive azoospermia were untreatable.     Indeed, these patients were often referred to as being sterile or having testicular     failure. We start to use stem cell in treatment of such patients by injecting the stem cell     at the testis and the testicular artery in one group and at the testis only in other group   "
97591|NCT02008786|"     An emerging cause of heart attack in young women is a dissection (or tear) in the coronary     arteries. Many of these young women continue to have chest pain long after the tear has     healed and this is thought to be due to problems with their small blood vessels of the heart     (or microcirculation). We want to determine whether commonly used medications for coronary     artery disease including statins (for cholesterol) and angiotensin-converting enzyme     inhibitors (for blood pressure) reduce chest pain and improve small vessel function in these     patients.   "
97592|NCT02008773|"     The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in     comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working     (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who     are HSV-1 positive and early in the course of schizophrenia.      We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative,     will demonstrate significant valacyclovir efficacy for visual and working memory.   "
97593|NCT02008760|"     The aim of this project is investigation of patients' with chronic pain self-rated quality of     life, ADL function and level of pain before and after 3 months of intervention with N-3 fatty     acids from krill in combination with vitamin D3. Furthermore, the compliance of the patients     and the effect of the intervention on the patients' vitamin D status and cardiovascular risk     factors are studied.   "
97594|NCT02008747|"     Atrial fibrillation and chronic neuropathic pain are adverse events occurring after     posterolateral thoracotomy for lung resection. The continuous application of magnesium     sulphate may have a prophylactic effect. The investigators record the incidence of atrial     fibrillation during a seven day period after thoracotomy as well as the incidence of chronic     neuropathic pain during a three months period, comparing one group with a continuous     application of magnesium sulphate against one group without magnesium sulphate.   "
97595|NCT02008734|"     This is a Phase II study trying to identify whether short term treatment with PD0332991     yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at     surgery- or induces senescence as determined by SABG expression (IHC) in tumors from patients     with early breast cancer non-candidates for neoadjuvant hormonotherapy or chemotherapy, as     compared to no treatment.   "
97638|NCT02008175|"     Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive     steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual     acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young     patients.      The investigators intend to evaluate the effectiveness of conventional collagen cross linking     in young patients diagnosed with keratoconus.   "
97596|NCT02008721|"     MSA is a rapidly progressive disorder with an average survival time of about 7 years after     the first clinical manifestation. No potent symptomatic treatment is currently available. A     disease-modifying therapy does not exist either. The growing understanding in recent years of     the underlying pathological mechanisms of the disease allows the development of new treatment     options that have a modifying effect on the disease progression. Therefore, treatments are     urgently required that effect the central underlying pathological mechanism, which appears to     be the intracellular aggregation of toxic oligomers of α-synuclein.      EGCG, a polyphenol found in green tea, has shown to inhibit the formation of toxic     α-synuclein oligomers in vitro and has shown to transform α-synuclein-oligomers in non-toxic     oligomer species. There is also evidence for a neuroprotective effect in MPTP-mouse models of     PD and is an antioxidant and iron chelator. There are currently 63 clinical studies     (http://clinicaltrial.gov) in which EGCG was applied for various indications, such as     Multiple Sclerosis, various forms of cancer and Huntington's disease. All of which have shown     good tolerability and safety with the applied doses of EGCG of up to 1200 mg per day,     demonstrating the safety of the drug under controlled clinical conditions (see 5.3.1 for     hepatotoxicity in uncontrolled conditions).      These data provide a solid rationale for testing in a clinical trial if supplementation of     EGCG can interfere with the core disease mechanism in MSA and consequently retard the     clinical progression of the MSA-related disability.   "
97597|NCT02008708|"     The objective is to test the effectiveness of a village-led microfinance program, Pigs for     Peace, on health, household economic stability, and reintegration of trauma survivors to     family and community.      The five-year experimental trial will use mixed-methods to address the following aims:        1. Determine the effectiveness of a village-led microfinance program on participants health          and reintegration in intervention households compared to participants in delayed control          households. Health and reintegration will be measured at baseline and six, twelve, and          18-months post-baseline using self-report in both intervention and delayed control          groups. We hypothesize that at six, twelve and 18 months post-baseline participants in          intervention households will have improved health and increased reintegration to          families in comparison to participants in control households.        2. Determine the effectiveness of a village-led microfinance program on household economic          stability in intervention households compared to delayed control villages. Household          economic stability will be measured at baseline and six, twelve and 18 months post-          baseline using self-report in both intervention and control households. We hypothesize          that at six, twelve and 18-months post-baseline the intervention households will have          improved household economic stability in comparison to control households.        3. Examine the role of a village-led microfinance program on village-level health,          economics, stigma and reintegration of survivors and their families in intervention and          delayed control villages. Village members (n=5 in each village, n=50 total) will          complete a baseline and 18 month post-baseline qualitative interview to examine the role          of microfinance on village-level health, economics, stigma and reintegration in both          intervention and control households.   "
97598|NCT02008695|"     The investigators will test the effectiveness of a youth-led animal husbandry microfinance     program, Rabbits for Resilience, combined with the adult microfinance, Pigs for Peace (PFP),     program on youth, family and community resilience outcomes. The following aims will be     completed over the five-year longitudinal, mixed-method, cluster randomized community trial:      Specific Aim 1: Determine the relative effectiveness of a youth-led microfinance combined     with the adult microfinance on youth and family resilience outcomes (reduced mental health     distress, increased economic stability, improved family functioning) compared to a youth-led     microfinance only and adult microfinance only approaches.        -  We hypothesize that at six, twelve and 18-months post-baseline youth and adults in          households in the youth-led and adult microfinance approach will report improved          individual and family resilience outcomes compared to households in the youth-led          microfinance only and adult microfinance only approaches.      Specific Aim 2: Determine the relative effectiveness of a youth-led microfinance combined     with PFP microfinance on community resilience (e.g. social capital and participation in     community groups by youth and adults) compared to youth-led microfinance only and adult     microfinance only approaches.        -  We hypothesize that at 18-months post baseline in households in the youth-led and adult          microfinance will report improved community resilience compared to households in the          youth-led microfinance only and adult microfinance only approaches      Specific Aim 3: Determine if changes in youth resilience (caregiving ability, empathy and     outlook for the future) mediate the relationship between youth engagement in microfinance and     outcomes, as measured by reduced mental health distress, improved family functioning and     improved social capital.      Specific Aim 4: Examine youth perspectives on resilience in the context of multiple     adversities (war, poverty, loss of family, displacement, victimization). Youth participants     (N=50, ages 10-15 years) will be invited (with parent/caregiver consent) to complete at     baseline and 18 month post-baseline qualitative interview/group discussion to examine     individual, family and community resilience and what that they perceive as key to buffering     the negative health and social consequences of prolonged conflict and other adversities.   "
97599|NCT02008682|"     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and     safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese     subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible     subjects will continue their metformin background treatment during the trial.   "
97600|NCT02008669|"     Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of     disability after injury accidents in young adults. Among the many symptoms, fatigue is very     common with a significant impact on quality of life. Also, the disability caused by multiple     sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as     proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often     deficient in this population with consequences in physical performance such as endurance and     muscle strength. We propose to study the link between fatigue and shortcomings encountered in     a defined population of MS patients.   "
97601|NCT02008656|"     The study is designed to test the hypothesis that patients with Locally advanced rectal     cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision     (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival     (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT),     Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).   "
97602|NCT02008643|"     The number of studies concerning health related quality of life (HRQL) in children with food     allergy is very limited.      Only one study to date has compared HRQL of a group of children with food allergy to data     published on general population and other chronic diseases. This study concluded to lowest     HRQL scores in food allergic children compared to type 1 diabetes mellitus with important     impact on scores concerning social activities.   "
97614|NCT02008487|"     This study will test a special powder for ulcers caused by a variety of conditions such as     pressure that sometimes happen when a person is at the end of life. The powder will be     applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People who     are being cared for by hospice or palliative care organizations will be invited to be in the     study. The study will also find out if the powder is easy to use by caregivers as well as     improving the comfort and quality of life of the person who has the ulcer.   "
97615|NCT02008474|"     The purpose of this study is to examine different types of monetary incentive paradigms for     weight loss.   "
97616|NCT02008461|"     The investigators have conducted a prospective, double-blind, randomized study to assess the     comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus     botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were     assessed with the use of an implanted monitoring device (IMD).   "
97639|NCT02008162|"     To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe     emphysema and analyze relationships between bronchoreversibility response and     semiquantitative computed-tomography based emphysema severity measures.   "
97740|NCT02006836|"     Food intake has a great influence on blood glucose of patients with diabetes. This study was     designed to determine the glycemic index (GI) of a particular pomelo named Majia pomelo and     its effects on postprandial glucose (PPG) excursions in both healthy subjects and patients     with type 2 diabetes (T2DM).   "
97603|NCT02008630|"     The overall research aim of this study is to investigate changes in measures related to the     risk of falls among elderly with dementia participating in animal-assisted interventions.     Also relatives' experience of own and the elderly's situation during and after the     intervention will be examined. The design will be a prospective and cluster randomized     multicenter trial, but mixed-methods will be used to target different outcomes. The study     population will be elderly (age above 65) at day care centers diagnosed with dementia, or     having a cognitive deficit. The intervention will consist of 30 minutes sessions with     animal-assisted activity or animal-assisted therapy two times a week for 12 weeks in groups     of 4-6 participants. Control groups will receive treatment as usual. Research questions:        1. Is there an effect in use of ordinary and optional medication among elderly persons with          dementia at day care centers participating in animal-assisted interventions compared to          a control group?        2. Is there an effect on social interaction, quality of life, activeness and wellbeing          among elderly persons with dementia at day care centers participating in animal-assisted          interventions compared to a control group?        3. Is there an effect on balance among elderly persons with dementia at day care centers          participating in animal-assisted therapy compared to animal-assisted activity or a          control group?        4. Do relatives of elderly persons with dementia at day care centers experience a change in          their own and the elderly's situation after the intervention compared with before the          intervention started?   "
97604|NCT02008617|"     Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide     analgesia for the front of the knee. Postoperatively, these patients will often report pain     in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee     results in blockade of the genicular nerves of the posterior knee. These nerves originate off     of the tibial and common peroneal nerves and their blockade will result in improved posterior     knee pain relief and may decrease narcotic consumption compared to patients who receive the     same infiltration with normal saline.   "
97605|NCT02008604|"     The aim of the study is to verify the hypothesis that the microbial colonisation of the gut     is changed in patients after stroke and that the gut microbiome of severely affected stroke     patients differs from that of patients with only a short disruption of blood circulation in     the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in     stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of     stroke-associated changes in the microbiome with immunological parameters will be analyzed.   "
97606|NCT02008591|"     The primary objective of this study is to compare the onset and duration of the initial dose     of medications given through three different epidural (conventional epidural, combined spinal     epidural and dural puncture epidural) techniques for labor pain relief.      The secondary objective of this study is to compare the fetal effects of these three epidural     labor analgesia techniques.   "
97607|NCT02008578|"     The purpose of this randomized, double-blind, placebo-controlled trial of intravenous     hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine     the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed     following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a     larger study that will be powered to compare Flu-IVIG with placebo for efficacy.   "
97608|NCT02008565|"     The study is a multi-center, randomized, placebo controlled trial with participants     randomized into one of four groups:        1. placebo/usual care (educational pamphlet)        2. loperamide/usual care (educational pamphlet)        3. placebo/anal exercises with biofeedback        4. loperamide/anal exercises with biofeedback      The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be     compared between treatment groups using linear regression.   "
97609|NCT02008552|"     More than 5 million persons in France exposed, in last years, to the taking of the     Benfluorex.      Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks     Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients     developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed     during years without developing the slightest anomaly.      The hypothesis is the existence of a particular genetic susceptibility at the patients having     developed a valvulopathy continuation in the exposure in this medicine.      Existence of one varying genetics with strong effect. The purpose is to identify involved     genetic factors.   "
97610|NCT02008539|"     To evaluate the safety and tolerability of MSC_apceth_101.   "
97611|NCT02008526|"     Participants receive culturally relevant and specifically tailored text messages based on the     behavioral change theoretical constructs of Social Support Theory, Health Belief Model, and     Social Cognitive Theory. Participants are randomized into one of three conditions for an     8-week intervention period: Group 1: culturally relevant theory-based text messages     interactively transmitted by peer health educators (TXT-PHE); or, Group 2: the same     culturally relevant theory-based text messages transmitted by automation (TXT-Auto); or,     Group 3: assessment-only (AO) control with no theoretically based text messages. Participants     in all three conditions receive brief weekly text-message assessments on their     methamphetamine use and HIV sexual behaviors in the previous seven days. Data related to     intervention costs as well as relative exposure to each theoretical construct will be     examined to determine cost- and mechanism-effectiveness, respectively. The randomized     three-group design uses repeated assessments at baseline, at the end of the 8-week     intervention period, and at 3-, 6-, and 9-month post randomization follow-up. This study will     determine the differential immediate and sustained effects of transmitting theory-based text     messages by PHE (TXT-PHE) versus by automation (TXT-Auto), compared to an assessment-only     (AO) control condition among out-of-treatment, methamphetamine-using MSM for reductions of     methamphetamine use and HIV sexual risk behaviors. It is hypothesized that there will be     significantly greater reductions in methamphetamine use and HIV sexual risk behaviors from     text messages transmitted by PHE than by text messages transmitted by automation, which in     turn will produce significantly greater reductions than the AO condition (PHE > TXT > AO). In     addition, this study will determine the cost-effectiveness of TXT-PHE vs. TXT-Auto compared     to AO for reducing methamphetamine use and HIV sexual risk behaviors. The investigators     hypothesize that the TXT-PHE intervention will prove more cost-effective than TXT-Auto in     reducing methamphetamine use and HIV sexual risk behaviors, while the TXT-Auto condition will     prove more cost effective than the AO condition in reducing these same outcomes (PHE > TXT >     AO).   "
97612|NCT02008513|"     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02     vaccinations in patients with Alzheimer's disease. Patients, who have already participated in     AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in     the clinical trial is 19 months.   "
97613|NCT02008500|"     Aim of this study was to assess and compare the efficacy of a commercially available novel     herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a     placebo and non herbal potassium nitrate over a period of 12 weeks.   "
97617|NCT02008448|"     The investigators have conducted a prospective, double-blind, randomized study to assess the     comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions     (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with     persistent or longstanding persistent AF. Results were assessed with the use of an implanted     monitoring device (IMD).   "
97618|NCT02008435|"     The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in     overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing     the risk of developing weight-related health consequences. One-on-one DPP sessions, however,     are costly and the group-delivered DPP version, the Group Lifestyle Balance program (GLB), is     less effective (4% average loss of body weight). The aim of this two-arm parallel randomized     controlled trial is to increase the effectiveness of the GLB by integrating habit formation     techniques, namely if-then plans and their mental practice, into the program. The study will     provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting     weight loss and in reducing weight-related risk factors for chronic health problems.   "
97619|NCT02008422|"     The primary objectives of this control, single-center clinical study of EndostarTM Injection     with/without SOX protocols to treat advanced gastric cancer were to evaluate the clinical     response rate of Endostar injection concomitant with SOX on patients with advanced gastric     cancer, observe the progression-free survival time (PFS) of tumor and evaluate the safety and     tolerance of Endostar injection, while the secondary objectives were to observe the influence     of Endostar injection on chemotherapy-induced adverse reactions and evaluate the overall     survival time of EndostarTM injection concomitant with SOX on patients with advanced gastric     cancer by evaluating the response rate (RR) clinical benefit rate (CBR), progression-free     survival (PFS) and overall survival (OS).   "
97620|NCT02008409|"     The primary goal of the study is to evaluate the safety of the EndoLift Liver Retractor as an     internal laparoscopic liver retraction device. The secondary goals of the study are to     evaluate the efficacy of the EndoLift Liver Retractor as an internal laparoscopic liver     retraction device and to identify 'best practices' for device utilization.      This study evaluates the use of a specific type of liver retractor (EndoLift). Liver     retractors are often necessary during MIS procedures, but this retractor is the only device     which is deployed internally (NOT requiring additional skin punctures/incisions for placement     of the liver retractor device). All patients undergoing minimally invasive surgery (MIS) at     Duke Regional Hospital will be approached.      The new device is expected to have a minimal risk safety profile. The investigators believe     that these risks are no more than would be encountered by using any other commercially     available retraction device available on the market today. Data will be collected and     analyzed by the identified investigators. Continuous variables will be analyzed via T-test     and Chi-square analysis will be applied to discontinuous variables. Statistical analysis     software such as SPSS® will be utilized when necessary.   "
97621|NCT02008396|"     This randomized, double-blind study is intended to test the safety and feasibility of using     3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy, compared with placebo, to treat     social anxiety in autistic adults. Subjects will be randomly (by chance) assigned to receive     placebo or MDMA during two experimental sessions. The first six subjects in the study will be     randomized to placebo (2) or 75 mg MDMA on the first session and 100 mg MDMA on the second     session (4). The next six subjects will be randomized to placebo (2) or 100 mg MDMA on the     first session and 125 mg MDMA on the second session (4). The study will explore whether two     doses of MDMA, combined with selected therapeutic activities, can reduce social anxiety. The     study takes place in Los Angeles, California and requires about 15 visits to the study     location over several months. Study subjects will meet with the investigators three times to     prepare for the MDMA sessions, and they will meet with them on three occasions and receive     daily phone calls for safety monitoring for a week after each session. Blood samples will be     collected at baseline, two hours after drug administration during the second experimental     session, one month and six months after the second experimental session to measure amounts of     the hormones oxytocin, arginine vasopressin and cortisol in plasma. Subjects will return six     months after their second experimental session for measurements of and social anxiety and     other symptoms and an interview. Subjects will learn what they received at this visit.     Subjects who received placebo can go through treatment again to have two sessions with MDMA,     the first with 75 mg and the second with 125mg MDMA. Social anxiety, anxiety, depression,     stress, self-esteem, empathy, and quality of life will be measured before and after     experimental sessions.   "
97622|NCT02008383|"     There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2)     the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. In the     Combination Dose Finding cohort and the Combination Expansion cohort, we will combine     cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer     (CRC). In the Monotherapy MET Amplified cohort, we will screen at least 50 patients for MET     gene amplification (MET amplification). Patients with MET amplification will receive     cabozantinib only (monotherapy).      The primary objective of this open-label phase Ib trial are:        1. To determine the maximum tolerated dose and the recommended phase II dose for the          combination of cabozantinib and panitumumab in patients with KRAS wild-type metastatic          colorectal cancer and        2. To identify the objective response rate (ORR) of cabozantinib monotherapy in patients          with prospectively identified MET amplified metastatic colorectal cancer.      The secondary objectives are:        1. To describe the non-dose limiting toxicities of cabozantinib and panitumumab.        2. To describe the clinical activity (ORR, PFS, OS) of cabozantinib and panitumumab.        3. To describe the safety and tolerability of cabozantinib monotherapy in patients with MET          amplified colorectal cancer.        4. To describe the clinical activity (PFS, OS) of cabozantinib monotherapy in patients with          MET amplified colorectal cancer.   "
97623|NCT02008370|"     The investigators are presently using Exparel, a slow released local anesthestic, in patients     undergoing minimally invasive cardiac surgery. The primary objective of this study is to     assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to     provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac     surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the     subject's overall postoperative pain scores and postsurgical analgesic use.   "
97624|NCT02008357|"     The purpose of this study is to test whether an investigational drug called solanezumab can     slow the progression of memory problems associated with brain amyloid (protein that forms     plaques in the brains of people with Alzheimer Disease [AD]).   "
97625|NCT02008344|"     The purpose of this study is to determine if favipiravir is effective in reducing the time to     resolution of influenza symptoms.   "
97626|NCT02008331|"     The interest on gastrointestinal (GI) dysfunction in CKD has been growing in the last years.     it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic     microinflammation by promoting gut dysbiosis and bacterial translocation in the blood.     Another mechanism by which GI dysfunction contributes to systemic symptoms in CKD is related     to metabolic activity of the dysbiotic microflora growing in the gut of these patients to     generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has     strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in     CKD. In the present paper the investigators investigated the effect of a probiotic/prebiotic     mixture on plasma p-cresol concentrations and GI symptoms and in CKD patients not on dialysis     yet.   "
97627|NCT02008318|"     The purpose of this study is to investigate the effect of the study drug known as LY2157299     on red blood cells in participants with myelodysplastic syndromes (MDS). Participants with     different degrees of disease (very low, low, and intermediate risk) will be studied. The     study treatment is expected to last about 6 months for each participant.   "
97628|NCT02008305|"     Interventional Neuroradiology replaces surgery. This technology requires various exposition     to X rays : number of X rays photographs, radioscopy, distance between patient and detector,     speed of acquisition of X-rays photographs, high tension and intensity.      The manipulator must find the right balance between quality of photographs and dose delivered     to the patient (optimization).      Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and     long life expectancy with risks. So, it is fundamental to optimize the dose delivered during     the procedures.      The investigators propose to analyse a study comparing two protocols of optimization of     doses. The investigators' hypothesis is that the protocol experimented in this trial allows     less radiation of the children, compared to the usual protocol.   "
97629|NCT02008292|"     The purpose of the study is to measure the sensitivity of NCFHEB binding to changes in     endogenous acetylcholine levels in healthy smoking and nonsmoking subjects, and in     schizophrenic smoking and nonsmoking subjects. We hypothesize that physostigmine-induced     elevated ACh levels will lead to a reduction in the availability of nicotinic receptors for     the binding of the radioligand. We hypothesize there will be greater increase in ACh level     (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects.     We hypothesize there will be greater increase in ACh level (or greater reduction in radio     tracer binding) in smoking as compared to nonsmoking subjects with schizophrenia, but the     extent of this change will be different than in controls.      We are also measuring the sensitivity of PHNO binding to changes in dopamine levels in     healthy smoking and nonsmoking subjects before and after amphetamine challenge.   "
97630|NCT02008279|"     The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated     in both Japanese and Caucasian men as well as to understand how the body absorbs and removes     the study drug after being injected or infused into the body.   "
97631|NCT02008266|"     This non-interventional, descriptive, cross-sectional and multicenter study will examine the     treatment of rheumatoid arthritis progressing for less than two years in the Algerian     population. Current drug therapy as well as disease status and patient function will be     assessed.   "
97632|NCT02008253|"     To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to     correct keratoconus on eyes with prior refractive surgery.   "
97633|NCT02008240|"     The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided     aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with     ultrasound visible hydrosalpinges undergoing IVF-ET.   "
97634|NCT02008227|"     This global, multicenter, open-label, randomized, controlled study will evaluate the efficacy     and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared     with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer     (NSCLC) after failure with platinum-containing chemotherapy. Participants will be randomized     1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as     participants are experiencing clinical benefit as assessed by the investigator, i.e., in the     absence of unacceptable toxicity or symptomatic deterioration attributed to disease     progression.   "
97635|NCT02008214|"     Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a     (IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on 54     to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected     patients. A previous study on HCV monoinfected patients showed that the addition of     pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased     SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV     coinfected patients.      On the other hand, other factors such as host genetics, have proved to influence treatment     response on HCV infected patients. The best described genetic factor so far is the     interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype     provides an almost twice increase on SVR than the rest of the genotypes.      Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline     addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV genotype     1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism rs12979860.      HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy (HAART),     with at least 8 months on undetectable HIV viral load and T helper cells count of 200 or     higher will be included. Patients will be randomized on one of two groups:        -  Group A: IFN alpha 2a + RBV + PTX        -  Group B: IFN alpha 2a + RBV + placebo      Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks     (for non rapid responses). Outcome measures will be the following:        -  SVR rate 24 weeks after the end of treatment        -  Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient          elastography and the AST to platelet ratio index (APRI index)        -  IL28B rs12979860 genotype      The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a     and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate     and fibrosis progression irrespectively of IL28B rs12979860 genotype.   "
97636|NCT02008201|"     The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a     group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the     effect that supplementation may have during the course of a year.      The study is a double blinded parallel study design.   "
97637|NCT02008188|"     The purpose of this study is to use an Advisory/Automated Adaptive (AAA) Control system for     insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate     the system's ability to significantly improve blood glucose levels. This protocol represents     a culmination of prior clinical trials in development of this AAA control system and benefits     from the synthesis of those components.   "
98209|NCT02000700|"     The purpose of this study is to evaluate the pharmacokinetics (blood levels) and     pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children     and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other purposes     are to investigate safety and assess the ease of swallowing the tablets.   "
97640|NCT02008149|"     Following a complete spinal cord injury (SCI), individuals experience progressive bone loss,     especially in the legs, with up to 70% of persons with SCI sustaining a fracture at some     point during their lifetime. Fractures following SCI are costly to treat and more than half     of patients experience a medical complication, requiring extended hospitalization, resulting     in a substantial impact on their quality of life. To reduce the incidence of fractures, more     effective rehabilitation strategies to prevent bone loss are needed. The goal of this     research is to determine if bone health can be preserved using an indoor rowing exercise     program in which the leg muscles are electrically stimulated using several, small surface     electrode pads that are placed on the skin on the front and back thigh muscles. An     encouraging case study has recently shown remarkable bone preservation in one individual with     SCI who participated in an electrical stimulation rowing program, however, whether other     individuals with SCI can achieve the same benefit is currently unknown.   "
97641|NCT02008136|"     This protocol is a prospective, open label, pilot study examining the utility of three     established pain questionnaires (the Visual Analogue Scale (VAS), Neck Disability Index     (NDI), the Oswestry Low Back Pain Questionnaire and two novel pain scale devised by the PI)     as well as their relationship to three novel quantitative tools to measure the effect of     botulinum toxin injections for neck pain and back pain. The three novel methods for measuring     neurotoxin effect are: muscle twitch patterns using surface electromyography (sEMG), cervical     and lumbar range of motion using a neck and low back inclinometer, and skin surface     temperature readings using an infrared imaging camera.   "
97642|NCT02008123|"     The purpose of this study is to determine whether adding primidone will improve the     metabolism of clopidogrel thereby increasing metabolite levels within the blood stream and     platelet response to clopidogrel in patients who were previously found to lack adequate     response to clopidogrel. This information could help overcome clopidogrel resistance in     patients who are at risk for stroke or transient ischemic attack (TIA).   "
97643|NCT02008110|"     Preliminary data suggest a potential role for monitoring and up-titrate pharmacological     therapy of plasma levels of antigen carbohydrate 125 (CA125) following and admission for     acute heart failure (AHF).      This study will evaluate the effect of a CA125-guided management strategy versus standard     therapy on the composite endpoint of 1-year all-cause mortality or readmission for AHF in     patients recently discharged for AHF.   "
97644|NCT02008097|"     The goals of this study are to evaluate the efficacy of the B-flow capability on the LOGIQ E9     system in three clinical focus areas.        1. Liver transplant patients: Improved real-time visualization of liver vessels is needed          to improve diagnosis and assessment following stenting or angioplasty.        2. Renal artery disease: Improved real-time visualization of the renal arteries would          enable a more rapid and accurate assessment of renal artery disease (stenosis,          dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal artery          interventions.        3. Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta          perfusion and assay for potential ischemia.   "
97645|NCT02008084|"     The purpose of this pilot study is to learn what study factors are important in designing a     large, full-scale study of the effects of TRIA-662 on serum triglycerides (TG) and     high-density lipoprotein cholesterol (HDL-C) levels. In this study, patients will first enter     a Single-blind, dietary-controlled baseline period and receive 1000 mg placebo or active drug     three times daily with meals (i.e., breakfast, lunch, and dinner) for 6 - 8 weeks. If the     qualify to continue, they will then receive up to 2000 mg of active or placebo drug for an     additional 14 weeks. Active drug will be given to 48 patients and placebo drug will be given     to 16 patients. However, neither the patients not the clinic staff will know which patients     are on active or placebo drug until the end of the study.   "
97646|NCT02008071|"     The purpose of this study is to conduct a pilot randomized controlled trial, to determine     whether providing financial incentives for meeting daily step goals (a) increases the daily     step counts of participants, (b) increases compliance with the overall program (including     diet recommendations), and (c) increases weight loss.   "
97647|NCT02008058|"     This is a single-arm observational longitudinal study in of patients with metastatic     castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and     other symptoms.   "
97648|NCT02008045|"     The purpose of this study is to collect and compare information from cranial ultrasounds,     magnetic resonance imaging scans, neurological exam and neuropsychological assessments of     children. The investigators hope that the information collected in this study will help with     early screening, diagnosis and treatment of brain injury in newborns as well as identify a     connection between MR imaging (MRI-magnetic resonance imaging, MRS-magnetic resonance     spectroscopy) and neurodevelopmental outcome.   "
97649|NCT02008032|"     Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast     tomosynthesis) and conventional 2-D digital mammography devices with regards to patient     comfort and radiologist preference in women with breast implants.      Participants: Women with breast implants undergoing routine 2-D digital mammography.      Procedures (methods): 50 female subjects with breast implants undergoing conventional     screening mammography will be recruited to have a single view s-DBT in the mediolateral     projection. We will perform a patient preference study and radiologist reader study composed     of radiologists who have experience evaluating tomosynthesis images. A short survey will be     given to each patient about their preference in modality with respect to comfort. Each reader     will review the images and score the ease of interpretation, and their confidence of     interpretation.   "
98210|NCT02000687|"     This is a single-center, prospective, open label study in islet transplant recipients     following islet graft loss.   "
97650|NCT02008019|"     The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this is     a rare occurrence, and patients with incomplete resection have very poor therapeutic options.     In this context, it becomes important to find new therapeutic strategies to slow down tumor     progression and to reduce tumor size before resection.      Pre-clinical and clinical data suggest that EVEROLIMUS should be efficient as adjuvant and     neo-adjuvant therapy in chondrosarcoma.      Then, investigators propose a phase II, randomized, open label study compounded by 3 arms     (1:1:1) to assess efficiency of EVEROLIMUS as neo-adjuvant therapy in patients with primary     or relapsed chondrosarcomas :      ARM 1 = No treatment; ARM 2 = 2,5 mg Everolimus/day; ARM 3 = 10 mg Everolimus/day.      The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn   "
97652|NCT02007993|"     The aim of the proposed controlled clinical trial is to evaluate the effect of photodynamic     therapy (PDT) on the formation of volatile sulfur compounds (VSCs) from coated tongue and its     action on the severity of halitosis in adolescents using different treatment protocols.      HYPOTHESIS        1. - Null hypothesis: There is no change in halitosis following the use of photodynamic          therapy.        2. - Experimental hypothesis: There is a reduction in halitosis following the use of          photodynamic therapy alone or in combination with a tongue scraper.   "
97653|NCT02007980|"     The aim of this study is to identify the root cause for the significant discolouration of     Boston Scientific Percuflex based stents.   "
97654|NCT02007967|"     The overall objective of this proposal is to examine the feasibility and accuracy of     non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals     referred for transcatheter aortic valve implantation (TAVI).   "
97655|NCT02007954|"     The purpose of this study is to determine the feasibility and safety of using small beads     (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat     patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with     doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE)     DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to     deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows     for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the     targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into     the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and     more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and     blood tests (to include assessment of liver function and tumor markers) and by imaging     (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will     be exited from the study and followed for survival. Once exited from the study they will     continue to be eligible to receive the smaller beads (DEBDOX), should it be recommended.   "
97656|NCT02007941|"     The purpose of this study is to assess between the renal impaired patients and normal renal     function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When     prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of     instructions.   "
97657|NCT02007928|"     We propose a prospective multicenter study, whose originality lies in the inclusion of the     naive child and adolescent population. Its purpose is to evaluate the incidence of adverse     events related to the use of l antipsychotic drugs in children and adolescents with no     history of taking such drugs.      The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years,     (3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28 days     without taking antipsychotic before or with a history of antipsychotic over a maximum period     of three consecutive months and discontinued for at least 6 months.      Therapeutic monitoring during the 12 month study period will include clinical assessments and     laboratory testing. These assessments will be performed before treatment (at inclusion), and     at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.   "
97658|NCT02007915|"     To determine the safety and effectiveness of pamidronate in patients with radiographically     proven avascular necrosis which are the result of unstable (acute) slipped capital femoral     epiphysis, traumatic proximal femur fractures, traumatic hip dislocations, or idiopathic in     nature.   "
97659|NCT02007902|"     The primary aim of this study is to investigate the relationship between early plasma protein     levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims     are the following: i) to evaluate maternal and neonatal factors affecting plasma protein     level at birth; ii) to evaluate the relationship between plasma protein level and albumin     level on the first day of life; iii) to evaluate the association between early     hypoproteinemia and neonatal mortality and morbidity in very preterm infants.   "
97660|NCT02007889|"     Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux     (VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in     treatment of acute infection.The pathogenesis of APN is related to bacterial     virulenece,immune response,tissue factors,apoptosis and production of free radicals that lead     to fibrosis and renal scarring. Oxidative stress in renal cells may be a critical factor in     the pathogenesis of pyelonephritis whereas pharmacological management of the oxidative stress     response may provide a therapeutic effect in preventing renal pathologies. Animal model show     that L-carnitine alleviated oxidative stress, and acute renal inflammatory injury can be     prevented much more effectively by carnitine in addition to conventional antibiotic treatment     in pyelonephritis.This study is a simple randomized clinical trial (RCT) evaluating the     effect of L-carnitine in addition to antibiotic on preventing renal scaring after acute     pyelonephritis in children. Simple non- blind randomized clinical trial on 78 patients in 2     groups (intervention & control) is conducted.Children aged 1 month to 10 years with positive     urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based     evidence in favor of acute pyelonephritis were enrolled into a clinical trial. Patients were     excluded if they had neurogenic bladder, systemic hypertension, obstructive uropathy.     Patients in Intervention group are administered 50 mg/kg/day carnitine in divided 2-3     times/day (maximum 3 g/day) in addition to antibiotic regimens and patients in control group     received antibiotic regimens. Primary outcome is the development of renal scar by doing DMSA     renal scan on the 7th day of admission and six months after the intervention and compared     between groups and secondary outcome is the incidence and severity of pyelonephritis and     response to treatment.   "
98211|NCT02000674|"     All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the     pre hospital emergency context will be included in order to compare the use of     succinylcholine vs Rocuronium for prehospital emergency intubation.   "
97661|NCT02007876|"     In this pilot study a group of older adults undergoing midline laparotomy for     gastrointestinal malignancy will participate in a mobility and activity training (MAT)     program. MAT is designed to advance functional mobility and physical activity and spans the     pre-operative, inpatient, and post-operative period. Patients undergoing abdominal surgery     will be randomized to MAT versus control usual care and evaluated at their first appointment     4 weeks preoperatively (baseline), immediately prior to surgery, on hospital discharge, and 6     weeks post operatively. We hope to prove that abdominal surgery patients undergoing MAT will     show less decline and earlier recovery in functional activity, and trunk and thigh muscle     strength mass. This study is uniquely innovative in that it links functional activity     assessment and training and analysis of trunk morphomics (muscle mass) in exploring     mechanisms of post-operative recovery. Results from this pilot will be used to determine an     effect size for the recruitment of a larger cohort and to study key surgical outcomes,     including surgical complications, operative symptoms, hospital length of stay, and cost of     care.   "
97662|NCT02007863|"     Unrelated Cord Blood (UCB) transplant in children is a viable stem cell transplant modality     for patients with leukemia and myelodysplasia. UCB is now considered Standard Of Care in     cases where a suitable living bone marrow donor is not available. The survival of UCB is     similar to Matched Unrelated Marrow Transplant. This study is considered Research since UCB     is not a licensed product and requires investigational new drug (IND). THERE ARE NO SPECIFIC     RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell     treatment modality to pediatric patients who may require it after a conditioning regimen that     excludes Total Body Irradiation.   "
97663|NCT02007850|"     Quadriceps muscle strength is an important determinant of quality of recovery in elderly     patients after total knee arthroplasty. We try to compare the quadriceps muscle strength     change between 0.2 % ropivacaine continuous fixed femoral infusion and patient controlled     femoral analgesia group.   "
97664|NCT02007837|"     Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major     causes of maternal mortality worldwide, especially in low and middle income countries. This     trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin     D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced     hypertension in women at risk. Secondary and tertiary objectives include other maternal and     neonatal outcomes.   "
97665|NCT02007824|"     Study objective The purpose of this trial is to evaluate the efficacy and safety of the     investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic     wound.   "
97666|NCT02007811|"     The reconstitution of a functioning immune system after allogeneic stem cell transplantation     takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current     conditioning regimes. During the period of intense immune suppression the patients are     extremely susceptible to bacterial, fungal and, most importantly, viral infections.The     adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance     humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with     B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will     evaluate the functionality of the transferred B-lymphocytes in the patient.   "
97667|NCT02007798|"     An excellent recovery profile is critical for neurosurgical anesthesia. Rapid awakening,     smooth blood pressure and heart rate (HR), a higher degree of coordination, painless or mild     pain, as well as better tolerance to endotracheal intubation can avoid can increased     intracranial pressure, elevated blood pressure and rapid HR caused by emergency choking,     suffocation and agitation, and can reduce postoperative cerebral edema and the risk of     bleeding. In addition, it is easy for surgeons to timely evaluate postoperative patients'     neurologic function based on the excellent recovery from anesthesia. Up to now, there are     many methods and drugs to improve the quality of recovery period, but each of them has some     flaws. Dexmedetomidine, an emerging anesthetic adjuvant, exhibits a stable hemodynamic     recovery period, and cannot affect evaluation of neurological function with both the sedative     and analgesic effects. We propose the following hypotheses: (1) A small dose of     dexmedetomidine can be intravenously injected into patients subjected to craniotomy under     general anesthesia, in order to improve the recovery profiles and reduce the incidence of     emergence agitation. (2) Dexmedetomidine can reduce postoperative pain.   "
97668|NCT02007785|"     The purpose of the study will be to determine the effects of the Cognitive Orientation to     daily Occupational Performance (CO-OP) as a treatment program for individuals with     Parkinson's disease-related cognitive impairment. The potential effects of the CO-OP on     successful engagement in meaningful activities will be examined from participants' and     live-in caregivers' perspectives. Effects of the CO-OP on participant-perceived     health-related quality of life and caregiver burden will also be evaluated.      Hypotheses:        1. Training with the CO-OP will have an effect or multiple effects on participation in          meaningful activities and health-related quality of life for individuals with          Parkinson's-related cognitive impairment.        2. Training with the CO-OP will have an effect or multiple effects on caregiver burden and          health-related quality of life for caregivers of individuals with Parkinson's-related          cognitive impairment.   "
97669|NCT02007772|"     The purpose of this trial ist to investigate the difference of the efficacy of two systems     for breath support in patients with COPD.   "
97670|NCT02007759|"     The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation     (NMES) will provide a more efficient method of treating neonates with dysfunctional oral     feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates     at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG)     and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral     feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.   "
97698|NCT02007395|"     Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due     to its capability to detect and remove precancerous lesions. However, polypectomy is     associated with complications, such as bleeding and perforation, with an estimated overall     incidence of about 10%, with polyp size and right-sided location considered as major risk     factors. Aim of present study was to prospectively evaluate the early and delayed (30-days     follow-up) complications of polypectomy in a multicenter regional Italian real practice     setting   "
97671|NCT02007746|"     Patients with sickle cell disease many have a number of systemic complications, including     liver problems. Some of these liver problems lead to liver fibrosis/cirrhosis, secondary to     chronic blood transfusions. The purpose of this study is to investigate FibroScan readings in     patients with sickle cell disease and iron overload secondary to blood transfusions, and to     correlate the FibroScan results with Ferriscan. A comparison with the results of FibroScan to     patients with Sickle cell without known liver disease, who have never been on chronic     transfusions and with normal liver function profiles will also be made.The primary hypothesis     is that the results of FibroScan will correlate with the results of Ferriscan and liver     biopsy.   "
97783|NCT02006277|"     This study is intended to evaluate the sensory attributes and estimate the relative     bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses     by swirl and spit (Cohort 1) or will receive five oral single 250-mg doses with a washout     period of at least 14 days (Cohort 2).   "
97672|NCT02007733|"     Diarrhea is the second leading cause of death in children worldwide, and accurately assessing     dehydration status remains a crucial step in preventing morbidity and mortality from this     disease. While children with severe dehydration require immediate treatment with intravenous     fluids, children with mild to moderate dehydration have a significant reduction in hospital     length of stay and fewer adverse events when treated with relatively inexpensive oral     rehydration solution (ORS). While several clinical scales have been developed for assessing     dehydration in children, these scales have never been prospectively validated in a low-income     country setting, where the vast majority of diarrhea morbidity and mortality occurs in     children.      The investigators hypothesize that new clinical and ultrasound-based tools will improve the     diagnosis of severe dehydration in children with diarrhea in low-income countries, reducing     the morbidity and mortality that occurs as a result of under-diagnosis of severe dehydration     as well as the adverse events and inappropriate utilization of scarce resources that occurs     as a result of over-diagnosis of severe dehydration.   "
97673|NCT02007720|"     The purpose of the study is to evaluate the efficacy, safety and tolerability of intravenous     infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.   "
97674|NCT02007707|"     The goals of the study are to develop smoking cessation intervention using lay health worker     (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in     Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a     two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108     dyads of a smoker and a family member from the same household. The hypotheses are:      H. At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive     the proposed ―Quit Smoking For a Healthy Family Intervention, a Family-based Intervention     (FI), will be more likely to achieve biochemically verified 7-day point prevalence of smoking     abstinence when compared to those receiving an attention control intervention (CI).      H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit     attempt than those in CI.      H3. At 6-month, FI participants will be more likely to report using a recommended     evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation     medications, advice from health professionals) than those in CI   "
97675|NCT02007694|"     Recent advances in animal research have identified pharmacological agents that appear to both     accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine     hydrochloride (YOH). A finding in animal literature is that the administration of YOH during     extinction trials accelerates fear reduction and may convert ineffective exposures in to     successful ones. It is thought that the mechanism of enhanced emotional memory is through     elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized     controlled trial claustrophobic participants underwent exposure in combination with YOH or     placebo. The YOH group showed significantly better results on anxiety improvement than the     placebo group. In a more recent study with participants with fear of flying no additional     benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies     by enhancing the dose of YOH in combination with VRET and by extending our experimental     design with another group which receives propranolol in combination with VRET. Propranolol is     β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy     humans. In this randomized controlled trial a between groups design is chosen to further     characterize the differential within and between trial extinction and to enhance possible     between groups effects. Sixty participants with fear of flying or fear of heights will be     randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus     Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three     sessions of VRET over a period of two weeks.   "
97676|NCT02007681|"     The main purposes of this randomized cross-over trial are to test if a 3h/day reduction of     time spent in sedentary behaviour (SB) through breaking up hourly and shifting it for     standing and walking behaviours would substantially increase total (TEE) and PA energy     expenditure (PAEE) compared to a week of habitual prolonged SB, in male and female     overweight/obese inactive (which do not attained MVPA recommendations) and sedentary desk     workers. Specifically using an experiment design our main aims are: a) to determine the     impact of reducing SB on TEE and PAEE; b) to analyse the independent effects of interrupting     SB through breaks and the overall reduction in SB on TEE and PAEE; c) To analyse the     determinants for the overall reduction in SB; d) If the changes occurred in TEE and PAEE were     dependent on specific covariates.   "
97677|NCT02007668|"     Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo     Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive     the correct application of the method described. The placebo group will receive a medical     adhesive tape. The control group will not receive any form of intervention.   "
97678|NCT02007655|"     The primary objectives of this study are:        -  To estimate the incidence rate of unexpected adverse events        -  To characterize the bleeding events and assess risk factors of bleeding        -  To identify ancillary baseline variables that may also be associated with adverse          outcomes   "
97679|NCT02007642|"     The study patients are patients suffering from primary or secondary immunodeficiencies     investigated in the Hospital Necker for a suspected infectious disease.      The study purpose is to assess the performance of a High Throughput Sequencing method, the     PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic     diagnostic approach.      The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible     for an infectious disease episode and will also evaluate the delay of obtention of results     compared to the classic diagnostic approach.   "
97687|NCT02007538|"     In the diagnosis of lung cancer, the cytological sample obtained during Bronchoscopy (FBS),     has an increasingly important role in the characterization of malignancy. The cytological     sample can be harvested during bronchoscopy by bronchial brushing, bronchial lavages or fine     needle aspiration. Immunocytochemical staining allows not only to discriminate between small     cell lung cancer versus non-small cell lung cancer (NSCLC), but also to identify the     expression of specific markers such as TTF-1, CK7, CK20, 4A4, 34βE12 and p63. Thin Prep is a     technique for cytological assay already validated and largely used in the immunocytochemical     determination of gynaecologic specimens. Further Studies are required to asses the accuracy     of this technique compared to conventional smear in cytological airway samples obtained by     fine needle aspiration.   "
97680|NCT02007629|"     BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and     may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary     arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved     the right heart function without unacceptable side effects. Here dose of Riociguat will be     adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary     Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg     Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on     previous evidence and on the different modes of action an improvement of exercise capacity,     heart function and quality of life may be expected if PDE5i treatment is transitioned to     riociguat.      Where Riociguat is pending market approval or reimbursement once the treatment phase is     completed drug can be made available for another 18 months (Extended Drug Supply Phase -     EDSP) under study conditions. Patients may also transition at the end of the maintenance     period or any time during the EDSP to any program that is intended to provide riociguat until     drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named     patient program. Study termination is also possible at any time.   "
97681|NCT02007616|"     The ageing of the population will inevitably lead to a growing number of older people living     alone and in need of care. Given the high cost of geriatric care, a critical research issue     is exploring ways to improve or maintain cognitive and functional status in old age.     Unfortunately, it has been shown that training those specific cognitive processes most     sensitive to ageing (such as speed of processing or working memory), produces only limited     beneficial effects. However, research also suggests that factors such as cognitive     engagement, physical activity and social context may act as more general modulators of     cognitive decline. This project is a longitudinal study with experimental and control groups.     It is inspired from the engagement model of cognitive optimization suggesting that a     lifestyle marked by social and intellectual engagement may mitigate age-related declines on     cognitive functioning. It uses new cutting-edge information computing technology (ICT)     solutions to improve or simply maintain cognitive functions in the elderly. This research     investigates how the treatment reduces the effects of cognitive age-related decline in     executive control processes and episodic (explicit) memory using behavioral and imaging     measures. The results will provide significant knowledge on the potential of new ICT     technologies to delay, compensate, and even prevent common chronic problems experienced by     the elderly population. The hypothesis is that cognitive training with video-games through     ICT solutions will promote brain and mental health and independence. Ultimately, the     objective is to contribute to the understanding of factors that help avoiding the (personal     and economic) consequences of long-term care in geriatric institutions.   "
97682|NCT02007603|"     The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and     amoxicillin/clavulanic acid during intermittent haemodialysis.   "
97683|NCT02007590|"     To investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure,     increases six minute walk distance (6MWD) and reduces exertional breathlessness in patients     with severe chronic obstructive pulmonary disease (COPD).   "
97684|NCT02007577|"     The possibility that obesity-associated inflammatory changes may play a role in the     pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that     salicylates might represent a useful treatment to improve glucose tolerance. Several studies,     performed in patients with 2DM, as well as in nondiabetic, obese individuals, have     demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but     have not led to a coherent view as to the mechanism(s) involved.      In this research proposal we will use specific methods to quantify insulin mediated glucose     uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance     (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the     insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers     to identify those individuals who are sufficiently insulin resistant to be enrolled in this     study. We will then use the graded glucose infusion technique in these insulin resistant     subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline     measurements, salsalate or placebo will be administered for one month to the participants,     after which time the IST and the graded glucose infusion will be repeated to quantify and     compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus     placebo. These results will provide for the first time quantitative data of the effect of     salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic     individuals.   "
97685|NCT02007564|"     The research activities funded through PAR Dissemination and Implementation Research in     Health in grant R21NR011112 Legacy Intervention Family Enactment (LIFE) have been varied     and highly successful. The LIFE project was designed with three primary objectives. Aim 1 was     to assess the efficacy of LIFE as delivered by Retired Senior Volunteers (RSVs) on palliative     care patients': (a) mood and emotional experience; (b) physical symptom burden; and (c)     experience of meaning. Aim 2 was to assess the efficacy of LIFE as delivered by RSVs on one     primary family caregiver's: (a) caregiving stress; (b) mood and emotional experience; and (c)     experience of positive aspects of caregiving. Aim 3 was to assess the ability of RSVs to     deliver LIFE effectively.      Although hospice and palliative care social workers frequently use reminiscence and creative     activities with their patients 16, such interventions need to be more accessible to patients     and families transitioning from community, hospital, and palliative care settings. If hospice     or palliative care is not chosen as a treatment option, few means of delivering therapeutic     reminiscence-based interventions exist. This represents a significant gap in practice and in     the psychosocial palliative care intervention literature. Kazdin and Blase (2011) argue     cogently that the community need for mental health services far outstrips the number of     providers available to assist those in distress. They call strongly for new intervention     delivery modes targeting prevention and treatment to alleviate suffering. Hence, the purpose     of the present study was to evaluate the effectiveness of retired senior volunteers (RSVs),     who are available nationally through the National Senior Corp Program, to deliver a     three-session reminiscence and creative activity intervention previously found effective in     improving palliative care patient and caregiver outcomes (Allen, 2009; Allen, Hilgeman, Ege,     Shuster, & Burgio, 2008). We hypothesized that palliative care patients and their caregivers     in the RSV-delivered intervention group would demonstrate improved emotional and spiritual     functioning relative to a supportive contact control group. If successful, this mode of     treatment delivery (e.g., RSV intervention) would represent a significant step toward     translation and greater access at earlier disease stages of therapeutic psychosocial     interventions for individuals near the end of life and their family members.   "
97686|NCT02007551|"     The purpose of this study is to evaluate the impact of a psychosocial and nutritional     intervention, entitled RelAte, on cooking and mealtime behaviours of older adults who are     living alone and at risk of social isolation. The intervention will be delivered in the home     of participants by a trained volunteer of a similar age.   "
98658|NCT01994811|"     The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research     study that examines the lifestyles, eating habits, and health behaviors associated with     cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.   "
97688|NCT02007525|"     The investigators propose to pilot test a six-week yoga program among adults with peripheral     arterial disease (PAD). Participants (n=50) will be randomized to a six-week yoga     intervention (n=25) or wait-list control (n=25). The yoga intervention will include a weekly     yoga class currently used among cardiac rehab patients at the University of Michigan Health     System, together with home-based practice sessions. Participants will perform treadmill     testing at baseline and 6 weeks to assess walking capacity. The primary outcomes of interest     include 1) acceptability of the program by participants, 2) feasibility of recruitment, 3)     change in maximal walking distance, 4) change in claudication symptoms, and 5) change in     health-related quality of life (HRQOL). The investigators expect this will inform us on the     acceptability and feasibility of a larger proposal examining yoga in PAD patients. These data     will also inform on the effect size in maximal walking, and HRQOL, which will be used to     estimate the sample size needed for a larger R01 level proposal.      Study hypotheses:      Hypothesis 1: Participants will find the yoga program acceptable with low drop-out rates     (<15%), excellent attendance (>80% classes attended), and good completion of the home-based     practice sessions (self-report >80% completed).      Hypothesis 2: The yoga intervention will be feasible for a larger study based on numbers of     potential participants approached, and those who consent to participate vs. those who do not.      Hypothesis 3: Increases in maximal walking distance and pain-free walking distance (from     baseline to 6 weeks) will be greater in the participants randomized to the yoga intervention     compared to the control group.      Hypothesis 4: Self-reported claudication symptoms will be reduced to a greater degree (at 6     weeks) among participants randomized to the yoga intervention compared to the control group.      Hypothesis 5: Increases in HRQOL (from baseline to 6 weeks) will be greater in the     participants randomized to the yoga intervention compared to the control group.   "
97689|NCT02007512|"     The purpose of this study is to determine if enzalutamide given in combination with     exemestane is safe and effective in patients with advanced breast cancer.   "
97690|NCT02007499|"     The investigators hypothesized that pre-arrival instructions would increase the likelihood of     bystanders performing Cardiopulmonary Resuscitation (CPR).   "
97691|NCT02007486|"     Dyspnea (breathlessness) on exertion is the most prevalent and distressing symptom of heart     failure (HF). Nevertheless, the mechanisms of dyspnea in HF remain poorly understood. Thus,     the general aim of this pilot study is to advance our understanding of the mechanisms of     activity-related dyspnea in patients with HF. Studies will be performed in patients with     mild, moderate and severe HF (n=24) as well as in healthy, age- and sex-matched control     subjects (n=8). We will test the hypothesis that the increased prevalence and severity of     activity-related dyspnea in HF reflects the interaction between an exaggerated drive to     breathe and the inability of the respiratory system to meet this increased demand. Detailed     physiological and perceptual responses to bicycle exercise will be examined and compared,     first, between HF patients and healthy control subjects and, second, across patients with     varying degrees of HF severity. The results from this preliminary study will be used to help     design future studies in this patient population.   "
97692|NCT02007473|"     The objective of this non-interventional study is to gather data on adverse reactions     occurring with Methylene Blue plasma administered in a routine clinical practice environment;     to know more about their characteristics and behaviour and the possible factors that may     influence their presentation and evolution.   "
97693|NCT02007460|"     Osteoporotic fractures are an extremely common and serious public health issue which     contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in     bone strength combined with an increase risk of falls (associated with decline in muscular     function with age) are the main determinants of fracture risk. Exercise that is novel and     involves impact loading has the potential to improve bone strength and neuromuscular function     (strength, power and balance). It is thus imperative to evaluate potential benefits of     exercise in older people. The musculoskeletal responses to exercise may also be influenced by     vitamin D status. It is the purpose of this study to consider the influence of a one year     unilateral (one limb) high impact exercise programme on musculoskeletal health, specifically     bone structure, muscle strength and power in older caucasian men. It is also the purpose of     this study to determine whether this differs according to vitamin D status. The findings will     reveal whether exercise can improve bone health and/or neuromuscular function, and whether     improvements are dependent upon vitamin D status.   "
97694|NCT02007447|"     This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum     Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life     and disruptive behaviors.      Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive     behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills,     quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with     the use of oxytocin.   "
97695|NCT02007434|"     The objectives of this study are to determine the safety of deoxycholic acid subcutaneous     (SC) injections in the submental area and to evaluate the effects of four interventions,     relative to placebo in the submental area, particularly with regard to assessment and     management of pain, bruising, and swelling/edema.   "
97696|NCT02007421|"     SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of     human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more     than 90% of anal cancer.      Gay men are over 20 times more likely than others to develop anal cancer.      SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will     provide important information to guide the possible future introduction of anal cancer     screening programs for gay men.   "
97697|NCT02007408|"     Objective: The investigators sought to investigate the analgesic efficiency of lidocaine     spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray     combination in patients undergoing first-trimester surgical abortion.      Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108     women with the request of pregnancy termination.The subjects were randomly assigned into four     groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and     placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard     Visual Analog Scale (VAS).   "
98659|NCT01994798|"     This registry is designed to assess the clinically relevant benefits of balloon angioplasty     and stenting in superficial femoral and popliteal artery, using rapid exchange technology.   "
97724|NCT02007044|"     You are being asked to take part in this study because you have chronic lymphocytic leukemia     (CLL) with a chromosomal abnormality (17p/TP53 deletion) or CLL that has come back after     treatment.      The goal of this clinical research study is to learn if the combination of ibrutinib and     rituximab can help to control CLL better than ibrutinib alone. The safety of these treatments     will be also studied.   "
97804|NCT02005991|"     This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's     Disease, distributes in the brain after one dose of PF-05212377 is administered orally to     healthy volunteer subjects. The study will also evaluate the safety and tolerability of     PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.   "
97699|NCT02007369|"     According to the Census & Statistics Department, there are still 659,300 daily smokers     (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers to     quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but they     could not maintain abstinence. Relapse prevention is aimed at providing interventions to     prevent relapse after starting the abstinence status. This pilot single-blind randomized     controlled trial (proof of concept study) will test the effectiveness of social networking     services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for     a qualitative interview for the design of intervention. Then, the pilot-RCT trial will     recruit 120 participants who have recently quitted smoking, and they will be randomly     allocated to 2 intervention groups and one control group. The 2 intervention groups will be     arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group     moderators and sharing quitting experience with other participants. All participants will     receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3     months and 6 months. The primary outcome is the self-report relapse rate (Relapse is     tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT among     the 3 study arms.   "
97700|NCT02007356|"     To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed     virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent     infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment     refractory post-transplant viral infections. The CCS has already been successfully used in     clinical studies in Germany and United Kingdom (UK).   "
97701|NCT02007343|"     This study aims to assess how large an additional disease burden and what extra costs are     generated by antibiotic resistance in patients suffering from infections caused by     gram-negative bacteria, such as Escherichia coli and Pseudomonas aeruginosa, in hospitals in     the Netherlands.   "
97702|NCT02007330|"     Systemic lidocaine administration may improve postoperative pain and recovery after     laparoscopic inguinal hernia repair in pediatric patients   "
97703|NCT02007317|"     This study is single-arm, none randomized, open label, two-dose-cohorts, single center     clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients     with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned     surgical excision of the lesion.   "
97704|NCT02007304|"     The purpose of is to determine the preventive effects of Chinese herb supplement with panax     ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness     and vascular reactivity by using a double-blind randomized control design and to examine the     effects of a 12-week progressive eccentric resistance exercise training on arterial     elasticity and vascular reactivity, and whether a long-term supplementation would ameliorate     arterial stiffening effects elicited by exercise-induced inflammation and improve endothelial     function.   "
97705|NCT02007291|"     Life expectancy in Brazil has increased markedly over the last 30 years. Hence, age-related     disorders, such as Alzheimer's disease (AD), warrant special attention due to their high     prevalence in the elderly. Pharmacologic treatment of AD is based on cholinesterase     inhibitors (ChEI) and memantine, leading to modest clinical benefits both in the short and     long-term.      However, clinical response is heterogeneous and needs further investigation. Objective: To     investigate the rate of response to ChEI in AD after three months of treatment. Methods:     Patients with mild or moderate dementia due to probable AD or to AD associated with     cerebrovascular disease were included in the study.   "
97706|NCT02007278|"     The purpose of this study was to compare the effect of a fixed dose combination of     vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in     glycemic variability in patients with type 2 diabetes who have not achieved adequate control     of their disease prior to treatment with metformin monotherapy in optimal doses.   "
97707|NCT02007265|"     The purpose of this study is to determine whether simple, evidence-based clinical screening     be quickly and feasibly implemented (>85% of patients in an average of <6 minutes) in     large-volume urgent transient ischemic attack (TIA)/stroke clinics to identify individuals at     high risk for the three most common and devastating post-stroke co-morbidities (depression,     obstructive sleep apnea and cognitive disorders).   "
97708|NCT02007252|"     This study was designed to assess the safety, tolerability and efficacy of ACZ885 on     aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA). The purpose of the     study was to provide data to enable decisions regarding the further development of ACZ885 for     subjects with abdominal aortic aneurysms. The design of this study addressed the primary     objective of evaluating the change in aneurysmal size in subjects with AAA as a result of     treatment with ACZ885.   "
97709|NCT02007239|"     This study seeks to determine the efficacy of tocilizumab (TCZ) in patients with     hemophagocytic lymphohistiocytosis (HLH) and high cytokine levels (proteins involved in     inflammation) in an attempt to decrease the damage caused by these proteins; and secondarily     to assess its safety and impact on disease activity.   "
97711|NCT02007213|"     Patient reported outcomes (PROs) instruments are often used to measure meaningful treatment     benefit or risk in clinical trials. PROs allow patients voices to be heard in ways that     assist healthcare clinicians to address treatment effects and individual patient preferences.     Unfortunately, infants and young children, especially those with a debilitating disease, such     as neuromuscular disorders (NMD), may be less able to provide clear and concise information     about treatment effects. In this case, we often defer to parents and guardians (to be     referred to collectively as parents throughout protocol) to provide their perception of their     child s overall health and wellbeing. Including parents in the assessment process recognizes     the unique knowledge parents have of their child s development, reinforces their central role     in implementing interventions, and aids in their ability to make better-informed healthcare     decisions [1]. Yet, most parent-reports for young children are confined to overall quality of     life (QoL). While QoL is an important area of assessment, its meaning varies among different     ages and populations, and its results are often not precise enough to reveal small     differences within samples [2]. A more specific area of concern in children with NMD is     early-onset muscle weakness leading to difficulties in motor function.      The current lack of patient-centered, sensitive measures (based on motor function and item     difficulty hierarchy) that are suited for repeated assessments in infants and young children     with NMD represents a major obstacle to the rapid translation of promising therapeutic     interventions from preclinical models to clinical research studies. Multiple clinical outcome     measures used at a single time-point for capturing a child s functional status are     burdensome, difficult to interpret and do not provide us with comprehensive, meaningful     information to detect changes following an intervention [3]. Psychometric measures that can     be completed by parents make it possible to collect a considerable amount of data over many     time-points rather than being limited to a single clinical observation. Moreover, a     parent-observational measure that focuses on their child s functional performance in their     real-life will maximize the ecological validity of measures of motor development used for     clinical trials.      Objective: To develop a parent reported observational measure of motor development in infants     and young children, which will serve as a complimentary tool to clinical observation by     reporting motor function as observed in the home setting and which will be used in clinical     trials.      Study population: Parents of children aged 0-5 with neuromuscular disease and neuromuscular     experts in pediatrics.      Design: Qualitative (parent interviews, focus groups) and quantitative study (analysis of     newly developed questionnaire)      Outcome Measures: parental responses to phone interviews, neuromuscular expert responses to     focus groups, parental responses to cognitive interviews, validity and reliability of newly     developed questionnaire   "
97725|NCT02007031|"     Wintertime is associated with increased morbidity and mortality and a majority is related to     cardiovascular causes, such as myocardial infarctions, heart failures, and strokes. It is     also known, that both acute and long-term cold exposure increase blood pressure and cardiac     workload, and this may contribute to the observed excess morbidity and mortality during the     cold season.      Although the effects of cold on blood pressure are known among healthy people, these     responses among risk groups, such as hypertensive people, are not established. In addition,     changes in cardiac electrical activity or autonomic regulation are largely unknown. The     cardiovascular responses in the cold could be different among hypertensive people because of     disturbances in the circulatory regulation or function, such as aortic stiffening and     increased vasomotor tone of peripheral arteries due to endothelial dysfunction associated     with the disease. To assess this, a controlled experiment employing a cold exposure similar     to everyday winter circumstances in a subarctic climate was performed.   "
97784|NCT02006264|"     This prospective, randomized, single-blinded, placebo controlled trial will examine the     safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF)     vaginal ring when used continuously for 14 consecutive days.      The primary objective is to assess the safety of TDF vaginal rings when used continuously for     14 days by healthy, HIV-uninfected, sexually abstinent women, as compared with a placebo     vaginal ring.   "
97714|NCT02007174|"     Blockade of vascular endothelial growth factor (VEGF) with bevacizumab has been used to treat     abnormal vascular conditions of the anterior segment of the eye. In pterygium, anti-VEGF     agents have been recently proposed as primary treatments, such as perioperative adjuvants, as     well as treatments for pterygia recurrences after surgery. The aim of the present study was     to prospectively evaluate the effect of three subconjunctival bevacizumab injections in     patients with an early pterygium recurrence. Materials and Methods: The current study was a     non-randomized single central trial. The method of ensuring allocation concealment was     sequentially numbered. Patients with an early pterygium recurrence were selected and invited     to participate in the study. Recurrence was defined as the presence of corneal vessels with     concomitant conjunctival hyperemia within the first trimester after primary pterygium     removal, and only patients with primary pterygium recurrence were included. Patient related     factors such as pregnancy, women seeking to become pregnant, and lactating women were     excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05     ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were     photographed at the third, sixth and twelfth months after the last bevacizumab injection.     Photographic analyses were performed taking into account two pterygium areas: the first     measure included only the vessel area in the corneal surface, while the second measure     included, both, conjunctival and corneal vessel area (corneal-conjunctival area of     hyperemia). Neovascularization area of each pterygium was determined using digital slit lam     pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the     lesion.   "
97715|NCT02007161|"     Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of     healthy volunteers.   "
97716|NCT02007148|"     Second-line chemotherapy represents an option in gastric cancer, especially for patients with     adequate performance status. Two randomized phase III trials comparing 2nd-line docetaxel     with best-supportive care have reported a benefit in favor of chemotherapy. Capecitabine is a     fluoropyrimidine carbamate, which has a broader spectrum of antitumor activity than other     fluoropyrimidines. In gastric cancer xenografts. metronomic capecitabine inhibited     angiogenesis, growth of gastric cancer and improved survival with less toxicity. Given its     potential low toxicity, the combination of docetaxel and metronomic capecitabine needs to be     evaluated to assess efficacy and tolerability in patients with advanced gastric cancer     previously treated with a fluoropyrimidine-based and platinum-based chemotherapy.   "
97717|NCT02007135|"     The purpose of this study is to determine the concurrent validity of a newly developed     pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator     in the stimulation of muscle proprioceptors.   "
97718|NCT02007122|"     The study will be conducted to investigate the pharmacokinetics of ceftaroline during     continuous and intermittent renal replacement therapy.   "
97719|NCT02007109|"     Pediatric research in the management of nausea has been limited by the absence of a reliable     method to quantify the intensity of this subjective symptom. In adults, the visual analog     scale (VAS) is an accurate tool, but this has not been shown to be reliable in young     children. A scale is a series of points made on a line that will be used for measurement; a     mark on the far left of the line shows little pain and the mark on the far right means alot     of pain.   "
97720|NCT02007096|"     The purpose of this study is to determine if a Transabdominal Plane Block will decrease     patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical,     incisional) hernia repair with mesh.   "
97721|NCT02007083|"     Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a     compression of the the neural and vascular structures in the spinal canal. This often gives     neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today     the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical     treatment is well documented by several clinical trials, and a Cochrane review article from     2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical     solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the     literature of which surgical method that gives best long term clinical results. The     investigators are therefore planning a Randomized Controlled Trial, where they will compare     clinical and radiological results of three different surgical methods for LSS. The main     outcome of this study is to answer which surgical method that gives the best long term     clinical results. And, secondary outcome is to find out how much increase of the Dural Sac     Cross Sectional Area is needed to give a long time relief of the patients` symptoms.   "
97722|NCT02007070|"     This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in     participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for     programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab     will result in a clinically meaningful Overall Response Rate (ORR).   "
97723|NCT02007057|"     Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The     postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic     surgery but does not provide a satisfactory postoperative analgesia . The locoregional     anesthesia is recommended and includes several techniques: the interscalene nerve block, the     suprascapular nerve block, intra-articular injection of local anesthetic and subacromial     infiltration. The interscalene nerve block is currently the gold standard for anesthesia and     postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% .     However it must be carried out by teams experienced in the locoregional anesthesia because it     is operator -dependent. The suprascapular nerve block is a simple technique that can be     performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less     invasive than the interscalene nerve block and exposing the patient to fewer complications.     However, his interest was not assessed in the repair of tendons of the rotator cuff. The main     hypothesis of this study is that the suprascapular nerve block is as effective as the     interscalene nerve block in the prevention of early postoperative pain after arthroscopic     repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the     analgesic consumption while reducing the risk of complications related to regional     anesthesia.   "
98296|NCT01999569|"     The purpose of the study is to establish that sustained estrogen levels are the driving force     for the LH surge, and are thereby necessary for ovulation to occur. We predict that by     reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit     ovulation from occurring.   "
97726|NCT02007018|"     The purpose of this study is to determine, in patients who undergo an elective colorectal     resection through a midline laparotomy incision, whether the use of negative pressure wound     therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces     the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The     investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as     well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return     visits related to SSI.   "
97727|NCT02007005|"     The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of     abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder     cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor     remission and the influence on the one-year recurrence rate.   "
97728|NCT02006992|"     Effects on weight and weight gain will be monitored in healthy term infants fed assigned     infant formulas.   "
97729|NCT02006979|"     In rodents, a single bout of exercise prior to injection of a chemotherapy agent used to     treat breast cancer prevents or attenuates a number of markers of cardiac injury. This study     will investigate whether this finding translates to human breast cancer patients.     Participants scheduled to receive chemotherapy for breast cancer will be randomized to     exercise or no exercise 24 hours prior to every chemotherapy treatment. The effect on cardiac     function will be compared between groups noninvasively by echocardiography and     electrocardiography and a venous blood draw at baseline before chemotherapy, after the first     treatment and at the end of chemotherapy.   "
97730|NCT02006966|"     Systemic lidocaine infusion may improve the patients' chronic post surgical pain after     video-assisted thoracic surgery   "
97731|NCT02006953|"     The purpose of this study is to determine the best way to feed children after they have a     gastrostomy tube placed. The study compares bolus feeding to continuous feeding.   "
97732|NCT02006940|"     The study is devoted to the comparative analysis of the data received in patients with lung     pathology using new method of probe-based confocal laser endoscopy of distal airways and two     reference methods: high resolution computed tomography and morphology.   "
97733|NCT02006927|"     The goal of this study is to evaluate electrical stimulation of nerves responsible for     erectile function after surgery to remove the prostate (prostatectomy). Electrical     stimulation of the nerves responsible for erectile function is experimental. The     investigators hypothesize that the subjects can tolerate nerve stimulation.   "
97734|NCT02006914|"     This research is to investigate the nutritional supplement chromium picolinate. The     investigators are testing to see how effective this supplement is in treating insulin     resistance associated with HIV disease.   "
97735|NCT02006901|"     Introduction: This observational study is designed to test the equivalence between the     clinical effectiveness of microdecompression and laminectomy in the surgical treatment of     central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for     spinal surgery in the elderly, and as the oldest segment of the population continues to grow     its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or     wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was     formerly the standard treatment. In recent years a growing tendency towards less invasive     decompressive procedures has emerged. Many spine surgeons today perform microdecompression     for central lumbar spinal stenosis.      Prospectively registered treatment and outcome data are obtained from the Norwegian Registry     for Spine Surgery (NORspine).   "
97736|NCT02006888|"     The purpose of this study is to determine whether IBI-10090 injection is effective in the     treatment of inflammation associated with cataract surgery.   "
97737|NCT02006875|"     To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is     getting a popular idea. Previous studies seemed to support its effects on facilitating motor     recovery after stroke. This study focuses on the motor recovery of lower extremities.     Investigators conducted the study to evaluate the treatment effect of rTMS on the functional     performance of lower extremities in terms of postural control, balance, and mobility in     stroke patients. Investigators hypothesized that these performances could be improved through     the better motor control of lower extremities caused by rTMS.   "
97756|NCT02006628|"     A study to compare the change in symptom severity in patients with schizophrenia or related     psychotic disorder when treated with GWP42003 or placebo, added to existing anti-psychotic     therapy over a period of six weeks. Secondary objectives are to evaluate the effect of     GWP42003 on quality of life and cognition and to assess the safety and tolerability of     GWP42003.   "
97757|NCT02006615|"     We hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield     ability to upregulate the function of primary motor cortex and prefrontal cortex that play     key roles in motor and frontal memory processing.   "
98660|NCT01994785|"     This study will provide capnography monitoring during routine upper endoscopy and colonoscopy     with moderate sedation in order to see if it improves safety.   "
97738|NCT02006862|"     This clinical observational study aims to investigate the efficacy of olanzapine (Villamos ®)     in accordance with the instructions attached thereto in standard clinical practice, followed     by the physician to the patient.      This is a multicenter, non- interventional observational study , 6-month period without     preparing the patient to take the usual his medication . A total of 3 scheduled visits :     Visit 1 to Day 0 ( integration , base ) , Visit 2 at month 3 and Visit 3 at month 6 ( = end     of treatment) .      The purpose of the study is to demonstrate the efficacy and safety of olanzapine in patients     who are indicated . Will be monitored and recorded all the different concomitant therapy .     The treatment of each patient is an individual designated by the physician , according to     standard clinical practice and without any intervention research purpose .      During the six months of observation patients visit the clinic at the beginning (day 0 ),     intermediate ( 3 months ) and end (month 6). The purpose of these visits is regularly     monitored by their doctor for senile dementia and their behavior .   "
97739|NCT02006849|"     The purpose of this research study is to determine if the study drug H.C. Acthar gel slows     the progression of your kidney disease. This drug is a steroid-based medicine with fewer side     effects than other steroids used for treatment of kidney diseases similar to APOL1     nephropathy.   "
97741|NCT02006823|"     This study will explore ways to improve the effectiveness of patient Self Management at a     time when genetic test results guide new treatments that will dramatically increase the     possibility of cure of the hepatitis C virus.The study will also focus on the interactions     between provider and patients and the ways that technical work, adaptive work and adaptive     leadership foster patient self-management.This proposed 2 year exploratory mixed-methods 12     longitudinal case study will explore patients' and providers' explanations for how and why     they engage in technical work, adaptive work, and adaptive leadership and the ways in which     these strategies promote or pose barriers to patients' self-management of Chronic Hepatitis C     in the context of the new genetic test results and treatments. Specific aims are to:      1: Examine how technical work, adaptive work and adaptive leadership influence patients'     perceptions of their likelihood of cure and how this work relates to self-management during     12 to 24 weeks of treatment for Chronic Hepatitis C. Research questions are: 1.1) How do     patients describe their interactions with the providers? 1.2) How do these interactions shape     patients' perceptions of the likelihood of cure? 1.3) How do patients' understanding of their     interactions with the provider promote the use of or pose barriers to self-management during     treatment?      AIM 2: Describe providers' use of technical work, and adaptive leadership approaches during     clinical encounters,to include nurse education visits. Research questions are:      2.1) What technical work, and adaptive leadership approaches do providers use when sharing     treatment information with patients during the clinical encounters. 2.2) What explanations do     providers give for how and why they use technical work and adaptive leadership approaches?     AIM 3: Describe the trajectories of illness perceptions(Control/Cure sub-scale - Illness     Perception Scale), symptoms (M.D. Anderson Symptom Inventory) , viral load, and     self-management (Patient Activation Measure) in relation to patient and provider reports of     technical work, adaptive work, and adaptive leadership from the index clinical encounter to     the follow-up treatment response encounter (ranging from 12 to 24 weeks).   "
97742|NCT02006810|"     The main objective is to develop and validate new endothelial function markers discriminating     and reproducible by assessing the ability to reveal changes in endothelial function in     response to positive and negative nutritional stimuli.   "
97743|NCT02006797|"     This study will evaluate the impact of a communication between hospital pharmacist and     community pharmacists in addition to drugs reconciliation procedure at discharge. It will be     conducted in 21 french public hospitals.   "
97744|NCT02006784|"     This is an open label, pilot, observational, prospective study of the safety of inactivated     influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted     during the 2013-2014 influenza season. The study will test conventional and novel biomarkers     to assess disease flare and vaccine response and will also collect self-reported     signs/symptoms in reactogenicity diaries during the 14 days after vaccination.   "
97745|NCT02006771|"     This one-year randomized crossover study is proposed to compare the changes of postprandial     oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese     adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of     POS differ with meals from different cultures. Four cultural meals are chosen, namely     Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence     of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and     Northern Chinese population.   "
97746|NCT02006758|"     The purpose of this observational study is to further evaluate the safety and performance of     the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled     hypertension in clinical routine practice.   "
97747|NCT02006745|"     The purpose of the study is to explore the treatment of patients with acute hepatitis C     infection (infection acquired within the last 6 months) who are also infected with human     immunodeficiency virus (HIV).   "
97748|NCT02006732|"     The objective of this study is to assess the efficacy and safety of 12 weeks once daily     treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler)     compared with tiotropium and placebo in patients with COPD.   "
97749|NCT02006719|"     The objectives of this study are to assess the safety, effectiveness, and immunogenicity of     AA4500 in the treatment of adhesive capsulitis.   "
97750|NCT02006706|"     This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in     patients with active rheumatoid arthritis who have had an inadequate response to at least 1     DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15,     and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.   "
97751|NCT02006693|"     The objective of this study is to evaluate the AqueSys XEN Implant for the treatment of     moderate primary open angle glaucoma patients when medications have failed to control     intraocular pressure (IOP). Effectiveness will be evaluated by comparing medicated     preoperative, intraocular pressure to postoperative values. Additionally, the number of IOP     lowering medications subjects are on at each study visit will be compared to preoperative     medication.   "
97752|NCT02006680|"     The best way to measure whether treatment of children with central precocious puberty is     working is to do a hormone stimulation test (leuprolide stimulation test) that requires     injection of a medication and multiple blood draws to see if the hormonal response is     suppressed (blocked). The hypothesis of this study is that random measurement of the free     alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that     stimulate puberty, will provide an adequate alternative to the leuprolide stimulation testfor     monitoring efficacy of pubertal suppression with Supprelin LA®.   "
98673|NCT01994616|"     This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids     and hypertrophic scars in a large population of mixed Fitzpatrick skin types.   "
97758|NCT02006602|"     This will be an open-label, randomized, single dose, two-way crossover study. Each subject     will participate in both treatment periods and will receive single oral doses of candesartan     cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods     will be separated by a washout period of at least 7 days and no greater than 14 days. This     study aims to determine the relative bioavailability of a 16mg test formulation tablet of     candesartan cilexetil (GW615775) compared to an 16mg reference tablet of candesartan     cilexetil in healthy adult subjects. ATACAND is a registered trademark of the Astra/Zeneca     group of companies.   "
97759|NCT02006589|"     This will be an open-label, randomized, single dose, two-way crossover study. Each subject     will participate in both treatment periods and will receive single oral doses of candesartan     cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods     will be separated by a washout period of at least 7 days and no greater than 14 days. This     study aims to determine the relative bioavailability of an 8mg test formulation tablet of     candesartan cilexetil (GW615775) compared to an 8mg reference tablet of candesartan cilexetil     in healthy adult subjects. ATACAND is a registered trademark of the AstraZeneca group of     companies.   "
97760|NCT02006576|"     The Prostaglandin Inhibition for Emphysema (PIE) study will determine if a currently     available therapy, ibuprofen 600 mg three times daily, can block PGE production in the lower     respiratory tract and if this results in improvement in measures of lung repair function.   "
97761|NCT02006563|"     -  Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging          (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose          delivery in the treatment of brain tumors.        -  If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is          related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion          is located in the MTV area that is outside of the CTV.        -  Alternatively, if CTV > MTV, then the difference in volumes is related to higher          treatment toxicity.   "
97762|NCT02006550|"     Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out     normal cells, causing morbidity and ultimately mortality. The cancer stem cell theory     suggests that most tumors undergo a process of differentiation through which a relatively     rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of     cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result     of this cellular diversity, one or more cells within the tumor are likely to be resistant to     therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key     feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the     original intervention. The cellular programs driving the uncontrolled proliferation of many     solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in     CSC. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs     will be effective in the treatment of cancer. The investigators' research program focuses on     the elucidation of signaling mechanisms, control of cellular processes and discovery of small     molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental     to CSCs. Our preliminary results identified a novel Notch associated protein NACK that     functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human     solid tumors and is required for cell survival and tumor growth in notch -dependent tumor     cells. The investigators' aim is to further interrogate the link between Notch and Nack.   "
97763|NCT02006537|"     This study will investigate the safety and pharmacokinetics (PK) of a single dose of     GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and     age on drug exposure. The biliary metabolites in healthy young males will be investigated     using the Entero-test after a single oral dose of GSK2256294. This study will be conducted in     two cohorts (Cohort 1 and Cohort 2). Cohort 1 is open label in order to characterise the PK     profile of GSK2256294 in healthy young males and also to investigate the biliary metabolites     of GSK2256294. Cohort 2 uses a crossover design to allow comparison of the PK parameters of     GSK2256294 between in the fed and fasted state within subject and also to compare the PK     parameters of GSK2256294 between male and female subjects. A washout period of a minimum of 2     weeks has been chosen to allow and adequate washout of GSK2256294.   "
97764|NCT02006524|"     Silent atrial fibrillation is an important cause of unnecessary strokes. If diagnosed and     treated in time with anticoagulants, many disabling strokes can be prevented. In order to     improve the diagnosis of atrial fibrillation the MyDiagnostick is developed; a user friendly     and easy to use stick that diagnoses atrial fibrillation in one minute. During influenza     vaccination, many patients who are also at risk for atrial fibrillation visit the general     practice. This offers an ideal opportunity for screening for atrial fibrillation. The study     investigates the yield of screening for atrial fibrillation with the MyDiagnostick during     influenza vaccination (newly detected atrial fibrillation with corresponding CHA2DS2-Vasc     score).   "
97765|NCT02006511|"     Wound complications associated with surgical incisions range from minor to life threatening.     Surgical site infections occurring usually occur within 30 days and are one of the most     common surgical complications. Perigraft infections in groin wounds can be devastating. Even     superficial wounds can progress to deep wounds resulting in graft infection, need for     explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had     favorable results on closed wounds in trauma populations. Similarly, negative pressure wound     therapy has had positive benefits in closed incisions such as sternal wounds following     cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to     allow easier application of negative pressure therapy to closed wounds. Application of the     PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure     (VAC®) therapy with the added benefits of protecting the wound from contamination and     bolstering the wound edges for better approximation and consequently better aesthetic     outcome. However, no comparison between negative pressure therapy as a dressing and standard     wound dressings exists.      The purpose of this study is to assess the efficacy and safety of topical negative pressure     therapy application with Prevena™ versus standard of care wound therapy on closed groin     incisions in high risk patients undergoing vascular surgery.   "
97766|NCT02006498|"     This is a randomised study to examine whether high dose Sillymarin will be able to help     improve fat-induced liver damage in the liver. The study hypothesis is that high dose     Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better     than placebo.   "
97771|NCT02006433|"     The Investigators propose an investigation of the safety of deep brain stimulation (DBS) for     the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI).      Aim 1 is to determine whether DBS in the periaqueductal/periventricular gray region (PAG/PVG)     of the brain at analgesic intensities produces any systemic or neurological adverse effects     in patients with longstanding SCI (>1 year), either immediately or as a result of prolonged     application for up 40 weeks.      Aim 2 is to determine whether acute application of DBS in the PAG/PVG influences the severity     of spontaneous ongoing pain caused by longstanding SCI.      Aim 3 is to determine whether DBS in the PAG/PVG affects stimulus-evoked or persistent     hypertension (a major sign of autonomic dysreflexia) in chronic SCI patients.      Aim 4 is to determine whether prolonged PAG/PVG stimulation (for 40 weeks) leads to     cumulative changes in chronic pain severity or in the motor or autonomic symptoms of chronic     SCI patients.   "
97785|NCT02006238|"     This is a prospective, randomized, double-blind, crossover study. The purpose of this study     is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in     menopausal women. This study will require all prospective participants to fill out a week of     Hot Flash Diary to determine eligibility before beginning the study. All prospective     participants will be assessed for hot flash frequency, hot flash distress and hot flash     severity according to their perception in the Hot Flash Diary during the experimental period.   "
97772|NCT02006420|"     Scleroderma as well as numerous other rheumatologic conditions can affect the skin.     Scleroderma in particular involves skin thickening and hardening. Currently, evaluation of     skin involvement by scleroderma is assessed based on a combination of physical examination     and histologic assessment after biopsy. The investigators propose to measure skin hardness     using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear     wave velocity imaging (ARFI/SVI). The investigators hypothesize that ARFI/SVI may be able to     distinguish normal skin from skin affected by scleroderma (and other rheumatologic     conditions) as well as perhaps quantify the amount of fibrosis in the dermis. Such a     radiologic biomarker could be used to help confirm the diagnosis of scleroderma as well as to     follow patients over time and assess response to therapy and progression of disease.   "
97773|NCT02006407|"     This is a pilot study to assess the changes in white matter, in the brain, in response to     radiation therapy and correlate these changes with later declines in cognitive function.   "
97774|NCT02006394|"     Clinical and rodent studies have demonstrated the impact of specific dietary factors in     modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and     cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and     glycemic index. The investigators know from previous studies in the literature that reducing     the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results     in improved metabolic indices and reduced inflammation. These improvements can be observed     even within the context of persistent obesity. The investigators will implement a     reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and     reducing inflammation in obese subjects with the metabolic syndrome. The active diet will     include reduced glycemic index foods together with omega-3 fats and polyphenol supplements.     The primary hypothesis is that the dietary combination of reduced glycemic index foods,     omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more     efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese     subjects with the metabolic syndrome.   "
97775|NCT02006381|"     Measuring basal levels of plasma oxytocin in individuals with typical development across     childhood and adolescence using both extracted and unextracted EIA methods.   "
97776|NCT02006368|"     The purpose of this study is to determine the life span and functional characteristics of     platelets derived from whole blood that has been stored in a refrigerator for up to 21 days.     Currently, platelets are separated from red cells shortly after donation and stored at room     temperature for no longer than 5 days. This study is considered experimental because; 1) we     will be keeping platelets in the original whole blood donor unit in the refrigerator, and 2)     we will be reinfusing a small portion of that donation back into the study-subject-donor and     tracking how many of the transfused platelets from that unit circulate in the     study-subject-donor in the hours and days after transfusion.   "
97777|NCT02006355|"     This study aims at comparing continuous local anesthesia and femoral nerve bloc for total     knee arthroplasty in terms of post-operative recovery.   "
97778|NCT02006342|"     To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with     intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for     ICU admission compared to IV insulin with delayed administration of SQ glargine for the     treatment of diabetic ketoacidosis (DKA).   "
97779|NCT02006329|"     Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver dysfunction     worldwide. NAFLD may progress to nonalcoholic steatohepatitis (NASH) and in turn to     cirrhosis. To date, the detailed pathogenic mechanism of NAFLD including steatosis and NASH     is not fully characterized, although it is regarded as a hepatic manifestation of the     metabolic syndrome, sometimes it occurs in the absence of a metabolic syndrome. Based on     conventional models of two-hit and multi- hit hypothesis of NAFLD, the dysregulated lipid     metabolism and insulin resistance are considered as the first hit of the liver and the     following second hit or multi-hit likely involves oxidative stress, lipid peroxidation,     increased inflammatory responses, induced hepatic fibrosis and apoptosis. This emphasizes the     multi-factorial pathogenesis of NAFLD and the necessity to treat NAFLD with diabetes-like and     multimodal strategy. Several changes in dietary intake have occurred in the past few years,     including increased energy intake (24%), and increases in added sugars, flour and cereal     products, fruit, added fats and total fat intake. The increasing prevalence of NAFLD is     probably directly affected by the contemporary epidemics of obesity, unhealthy dietary     pattern, and sedentary lifestyle. Currently, there are two major categories of NAFLD therapy:     lifestyle interventions and pharmaceutical therapies, lifestyle interventions in terms of     diet and physical activity are regarded as safe and effective, while pharmaceutical     interventions showed limited efficacy with unknown safety in the long term ,therefore, the     first line of treatment is lifestyle modification. Although lifestyle intervention dose     positively affects NAFLD, it has limitations. Patients adherence to dietary intervention is     50%, while those who do adhere, find it difficult to maintain after 12 months. ).     Mediterranean diet has been shown to be effective in reducing NAFLD, liver steatosis and     improve insulin sensitivity. Acupuncture has been found as an effective treatment for     improving quality of life in various medical conditions , including hepatitis . Acupuncture     combined with life style intervention has been found effective in the treatment of obesity,     metabolic syndrome in terms of weight, lipid regulation, glucose levels and various markers     of inflammation. Acupuncture's effect on NAFLD has yet to be studied.      We suggest that acupuncture combined with life style intervention can be an effective     treatment for NAFLD.   "
97780|NCT02006316|"     The purpose of this study is to evaluate whether clinical varicoceles are associated with     abnormal semen parameters and whether varicocelectomy could improve the semen parameter in     patients unrelated with infertility.   "
97815|NCT02005848|"     A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the     Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New     Onset Type-1 Diabetes.      The study objectives are:        -  To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes        -  To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes          pediatric and young adult population.   "
97781|NCT02006303|"     The primary objective is to assess whether prostatic artery embolization has a similar     efficacy and safety profile as GreenLight PVP in treating patients with urinary retention     secondary to benign prostate hyperplasia (BPH). Subjects who consent will be randomized to     either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.      The primary endpoint of efficacy of the procedure is measured by the ability of the patient     to void. The secondary endpoints recorded will include patients' satisfaction measured by     International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual     urine volume (PVR) and prostate specific antigen (PSA) will be measured at 3, 6, and 12     months post treatment. Also, reduction in prostate volume is considered by MRI     preoperatively, 3 months and 12 months.   "
97782|NCT02006290|"     The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects.     Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be     evaluated.   "
97786|NCT02006225|"     Plerixafor has been intensively used in recent years for harvesting autologous stem cells     from lymphoma and myeloma adult patients. Its use is indicated after failure to harvest with     GCSF alone. Nevertheless, in the pediatric population its appliance is less well established     and the indications are less well confirmed .Several disease states and diagnoses may prompt     the anticipation of difficulties in harvesting stem cells using GCSF only. Such patients may     benefit utilizing plerixafor in first-line rather than exhausting the stem cell niche with     GCSF alone and only than go for plerixafor as second-line rescue procedure.      In this study we propose to examine the applicability and feasibility of harvesting     autologous stem cells by means of GCSF + plerixafor in first-line measure for pediatric     patients with specific indications.   "
97787|NCT02006212|"     Neurologic complications after cardiac surgery range over a wide spectrum including     postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular     accidents (CVA). The incidence of these neurologic events varies depending on the type of     surgery and the population studied. The incidence of PD and/or POCD is further influenced by     the type of the neurologic tests used. Moreover, the timing of these tests seems to influence     the results. Intraoperative cerebral monitoring is gaining importance in the anesthesia     field. Recent findings have pointed out that cerebral hypoperfusion on one hand and deep     levels of anesthesia on the other hand are major sources of adverse neurological outcomes,     both of which can be detected with different non-invasive cerebral monitors.The present     investigators are currently using the NeuroSENSE®, a processed electroencephalogram (pEEG)     monitor together with cerebral near-infrared spectroscopy (NIRS) on a daily basis in every     cardiac patient.      This large, prospective, observational study will investigate whether the short- and mid-term     neurologic outcome of adult patients undergoing cardiac surgery are in line with observations     made on the basis of the pEEG monitor NeuroSENSE® and cerebral NIRS.   "
97788|NCT02006199|"     Hypothesis of this study is that mindfulness meditation would decrease the severity of     obsessive-compulsive symptoms.   "
97789|NCT02006186|"     US children's active commuting to school (ACS; walking or cycling to school), previously     common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity     epidemic, which disproportionately affects low-income and ethnic minority children. Programs     to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity and     related chronic disease risk are necessary. The Bicycle Train is an innovative program in     which children cycle to and from school led by adults. Bicycle Trains provide another option     for ACS, especially for children who live too far to walk to school. No randomized controlled     trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent     of children who cycle to school is sub-objective PA-14 of US Healthy People 2020.      The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among     low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent     accelerometer and GPS data and validate algorithms to identify and measure physical activity     intensity and duration for children's cycling compared to heart rate monitors.      Our Specific Aims will be to:      SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot     cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned     full-scale cluster RCT (b) promoting their participation, and (c) identifying     barriers/facilitators to their participation; and SA2) validate algorithms examining     concurrent accelerometry and global positioning system (GPS) data to identify and measure     children's physical activity intensity and duration while cycling compared to the criterion     standards of heart rate monitoring and direct observation      Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to     test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be     determined to be feasible if:      FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle     Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on     average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data     have high agreement, i.e. >90% agreement, with heart rate data/direct observation in     distinguishing children's cycling-related physical activity duration and intensity from other     physical activities and riding in a motor vehicle   "
97816|NCT02005835|"     The purpose of this study is to determine if enhanced support for women and their families     within facilities and/or through community outreach will result in improved retention in the     continuum of PMTCT care.   "
97817|NCT02005822|"     The objective of the trial is to investigate whether early treatment with oral valganciclovir     of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can     prevent progression of hearing loss.   "
97818|NCT02005809|"     Gastroenterologists often follow up second look endoscopy after endoscopic submucosal     dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure     sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after     endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the     investigators try to identify the hypothesis prospectively in this study.   "
97790|NCT02006173|"     This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed,     single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan     University Hospital Research Ethics Committee. The aim of this post-marketing study is to     evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the     effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential     loss to follow-up, the minimum enrollment was statistically determined to be 40 patients.      The study was estimated to be held one and half year including a 0-2 weeks screening period,     a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms     will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF)     severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets     of randomized numbers are used, patient numbers and treatment numbers. Participants with odd     patient numbers will be assigned to nasolabial group and those with even patient numbers will     be assigned to nasolabial&cheekbone group. Participants receive experiment treatment     (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with     normal saline) in the other side of the face randomly depending on the treatment numbers.     Both physicians and participants are only blind to the treatment assignment. 30 minutes after     the injection, a post-photograph will be used to evaluate NLF severity scale scores and     global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the Visual     Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction will be     collected from patients. The effectiveness analyses compare NLF severity scale scores and     GAIS based on photograph records from physicians, as well as participant questionnaires for     each group on every visit. The safety assessment evaluates any recorded adverse events     following the device treatment.   "
97791|NCT02006160|"     Cognitive impairment is common in multiple sclerosis (MS) and has devastating impact on     functional activities. There is great demand for medications that will enhance cognitive     capacity in MS patients. To date, there is no evidence for improvement in cognition following     treatment with aminopyridines, but the few studies on the topic included neuropsychological     (NP) tests as secondary or tertiary outcomes, and were methodologically flawed. Dalfampridine     may enhance cognition by direct pharmacological mechanisms, and should have effects on motor     outcomes as in prior studies. By combining cognition and motor outcomes in the proposed     study, the investigators will evaluate if the same patients with positive effects show     beneficial responses on motor outcomes including physical activity and if such motor outcomes     mediate and/or moderate cognitive improvements with dalfampridine   "
97792|NCT02006147|"     The purpose of this study is to determine whether ProDex provides an ideal, safe,     long-acting, dexamethasone sodium phosphate (DSP) delivery system for the treatment of     macular edema due to retinal vein occlusion (RVO).   "
97793|NCT02006134|"     Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in     common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most     knowledge about them comes from adult patients. Severe disease requires aggressive     life-saving treatments with steroids and some cancer drugs which can themselves cause damage,     and increase risks of cancer and severe infections. Conversely, milder disease can be treated     with less toxic drugs. Different classification and scoring tools are used to define the     types and severity of vasculitis and to measure damage caused by disease or drugs. These in     turn help direct how aggressively to treat a patient and to measure outcome. None of these     tools however have been assessed in children and the best balance of disease and treatment     risks against outcome for children is not known. Although causes of these diseases in     children and adults are probably the same, the effects of the disease and the response (good     and bad) to drugs will differ in growing children. Because specialists may see only one new     child with vasculitis each year, obtaining enough information to learn about childhood     vasculitis requires cooperation. We will use an international web-based registry to which     doctors from 50 or more centers can contribute patient data. We will determine the features     which help better classify and diagnose children compared to adults. Through the web we will     collect and analyze information on patients similarly classified and scored so that most     successful treatments can be identified. Children with vasculitis are less likely to have     diseases associated with aging, alcohol and smoking etc., and therefore may be a better group     in whom to study the underlying biology of vasculitis. We will use this opportunity and     collect spit, blood and tissue from registry patients for laboratory study with an aim to     find biomarkers to better classify, define and direct optimal treatment and outcomes.   "
97794|NCT02006121|"     The main purpose of this study is to investigate the efficacy of apomorphine subcutaneous     infusion compared to placebo in advanced Parkinson's Disease patients.      The secondary purpose of this study is to investigate the safety and tolerability of     apomorphine subcutaneous therapy.   "
97795|NCT02006108|"     The goal of this study is to develop a non-invasive imaging test for in vivo detection of     kidney transplant rejection. The hypotheses are that 1) Ferumoxytol-MRI can generate accurate     estimates of tissue iron concentrations and tissue macrophages. 2) The signal given by a     renal allograft on Ferumoxytol-MRI demonstrates significant differences between rejected and     non-rejected transplants.   "
97796|NCT02006095|"     Carotid revascularization can significantly reduce the risk of stroke in patients with severe     carotid stenosis; however, it has been associated with cognitive decline in 25% of the older     adults who undergo the procedure. Characterizing risk factors for cognitive decline following     carotid interventions and individualizing treatment strategy based on those risks can     minimize procedure-associated cognitive dysfunction. Neuroimaging techniques that     characterize white matter integrity and regional hypoperfusion have the potential to provide     sensitive brain structure indicators that may be associated with memory decline following     revascularization procedures. In this protocol, we hope to determine how cerebral blood flow     and baseline white matter abnormality in the vulnerable region modify the frequency and     cognitive effect of microembolization following carotid revascularization procedures.   "
97797|NCT02006082|"     The purpose of this study was to evaluate the effects of telemedicine video-consultation     (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among     patients with chronic obstructive pulmonary disease (COPD). Our secondary aims were to assess     the impact of TVC on the length of recurrent hospital stays and time to re-admission within     12 months follow-up after TVC. We also wanted to evaluate the patient satisfaction related to     TVC.   "
97798|NCT02006069|"     The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing     (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac     Resynchronization Therapy (CRT) after 6 months.   "
97819|NCT02005796|"     In this study, the postprandial glycemia and insulinemia caused by boiled potato with     blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch,     is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids     and their metabolites is studied in plasma and urine.   "
97820|NCT02005783|"     To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with     EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The     aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by     EC/TC regimen during chemotherapy.   "
98023|NCT02003131|"     Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived     mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or     injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for     inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4     radiographic OA severity.   "
97799|NCT02006056|"     The primary objective of the study is to examine the efficacy of Ondissolve for the     prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in     patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for     painful bone metastases. The study population will be 30 patients seen in the RRRP at the     Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic     for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each     day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8     hours later the same day. Patients undergoing multiple fraction radiation therapy will take     Ondissolve on weekends or holidays in between treatment. Secondary objectives include to     evaluate key secondary endpoints related to RINV, and to investigate the ease and length of     administration of protocol medicine. We hypothesize that Ondissolve will be effective in the     prophylaxis of RINV, and the ease of use and administration will provide an appropriate     delivery method for those unable to tolerate the oral form of ondansetron.   "
97800|NCT02006043|"     evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or recurrent     NSCLC with EGFR wild type and without c-met expression   "
97801|NCT02006030|"     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been     used to treat patients that have cancers that require arginine. In this study, the     investigators will evaluate the response rate, as determined by the revised International     Working Group recommendations.   "
97803|NCT02006004|"     Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo     or secondary AML in the PETHEMA Group institutions. This study is a non-interventional     research regarding diagnosis and therapeutic approach   "
98916|NCT01991418|"     In pre-clinical study, we found that serum thioredoxin reductase activity harbours huge     difference after any kind of treatments, so we hypothesis that serum activity of thioredoxin     reductase may be a warning markers in excised non-small lung cancers, serum activity of this     enzyme may elevated before CT scan   "
97805|NCT02005978|"     Acromegaly is caused by increased production of growth hormone (GH) from a usually benign     pituitary tumor. The disease causes a number of complications including disturbances in     glucose metabolism and about 25% of the patients develop diabetes. Most patients are cured     upon surgery alone, but many require additional medical treatment, and in rare cases     radiotherapy. A disadvantage of radiotherapy is a risk of radiation damage to nearby areas     such as the hypothalamus. The true extent of irradiation induced hypothalamic dysfunction,     however, remains uncertain.      Data have shown significant improvement and often normalization of glucose metabolism upon     surgical cure from acromegaly, whereas data suggest that such improvement is less likely in     patients receiving additional radiotherapy.      The hypothalamus is part of the so-called 'gut-brain axis', where gastrointestinal hormones     through interaction with the hypothalamus plays a significant role in the regulation of     appetite and glucose metabolism. Incretins are the most prominent gastrointestinal hormones     involved, with the incretin-effect referring to food-induced insulin secretion, which in     healthy subjects is responsible for up to 70% of the insulin response after oral glucose     intake. The investigators hypothesize that radiation conditional influence of the     hypothalamus may compromise the gut-brain activity and thereby affect the incretin-effect and     gastrointestinal-mediated glucose disposal (GIGD; i.e. sum of all gastrointestinal-derived     factors that contribute to glucose metabolism) in patients with acromegaly. The aim of the     study is to investigate the long term effect of surgery with or without additional     fractionated radiation therapy on glucose metabolism as assessed by incretin-effect and GIGD     in acromegaly, in order to identify possible associations with treatment modality.      The study population include 24 acromegalic patients who have previously received (N=12) or     did not receive (N=12) pituitary irradiation as part of their treatment, and 12 matched     healthy controls.   "
97806|NCT02005965|"     The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic     Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary,     multi-centre study. However, there were differences in patient outcome, dependent upon the     position of the tumour in the rectum and its height above the anal verge. Whilst the outcome     was excellent for patients who underwent an anterior resection, the outcome, based upon     margin involvement and quality of the specimen, was poor for patients who underwent an     abdomino-perineal excision for low rectal cancer.      It is proposed that accurate MRI staging pre-operatively will allow the correct patients to     receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection     margins appear threatened so that the operation can be modified to take this into account.     The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM     positivity rate in low rectal cancer and to assess the difference in global quality of life     at two years post surgery in patients according to plane of surgery with or without sphincter     preservation.   "
97807|NCT02005952|"     Still not well resolved access, execution and interpretation of spirometry in primary care     medicine. This seriously affects the quality of care of chronic respiratory diseases.      OBJECTIVE: To compare the effectiveness of two methods for quality control in performing     spirometry in primary care teams (EAP) participating in the Healthcare Process Chronic     Obstructive Pulmonary Disease (COPD ) (multidisciplinary program between primary care     medicine and hospital for improved care COPD).      METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality     control of spirometry in each EAP randomize into three branches:        1. Supervision from the pulmonary function laboratory of the Hospital ; computer.        2. Program incorporated into automated spirometer.        3. Spirometric usual practice (control group without any support on the quality ).          Spirometry EAP participants include year follow-up study . All sites use the same model          spirometer and have received the same previous training . In a 2nd phase results          implementing the most effective method shown in the 1st phase was studied.      EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the     quality spirometry.      POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early     detection (secondary prevention ) , the diagnosis of the severity and developmental control     of COPD.   "
97808|NCT02005939|"     Biophenols can act as powerful antioxidants. Pomegranate (Punica granatum) provides a rich     and varied source of biophenols with the most abundant being ellagitannins, tannins,     anthocyanins, ellagic and gallic acids. Interest in antioxidant polyphenol-rich pomegranate     products has increased in recent years with growing reports of potential health benefits.     Pomegranate biophenols have been noted to lower systolic blood pressure, salivary stress     hormones and increase insulin sensitivity in previous trials involving participants who have     cardiovascular disease, but few studies have been conducted recruiting healthy volunteers,     and those have made use of pomegranate juice rather than extract.      The aim of this parallel study is to investigate the effect of pomegranate extract     supplementation on blood pressure, lipid profiles, salivary stress hormones, insulin     sensitivity, body composition and the perceived quality of life in healthy volunteers over 4     weeks.      It hypothesizes that consumption of biophenol-rich Pomegranate extract could increase insulin     sensitivity and perceived quality of life while decreasing blood pressure, body measurements     and stress hormones in healthy individuals.   "
97809|NCT02005926|"     -  This is a phase II, prospective, single-center, non-randomized, non-controlled study.        -  Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer.          The potentially increasing false negative rate of SNB was concerned if the sonographic          abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB          in breast cancer with sonographic abnormal axillary lymph nodes.   "
97810|NCT02005913|"     The best strategy to prevent colorectal cancer (CRC) death lies in early detection and early     treatment at the local disease status of tumor. After curative resection of tumor, there are     about 5~10% of stage I, 20~30% of stage II and 40~50% of stage III patients suffering     metastasis during subsequent follow-up periods. Although carcinoembryonic antigen (CEA) is     the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic     patients, it is difficult to use CEA as biological marker to identify the population with     high recurrent risk in patients with early-stage cancer because lower than half of patients     with early-stage cancer do not have CEA elevation. For improving the survival of patients     with early-stage CRC, we need effort to search more useful biological markers to predict the     risk of tumor recurrence and to select out patients with high recurrent risk to receive     preventive adjuvant therapy.      Circulating tumor cells (CTCs) in the blood play an essential role in cancer metastasis.     Hence, the detection of CTCs and subsequent analysis can potentially revolutionize the cancer     care ranging from screening, diagnosis, monitoring, to drug selection and so on. In the past     decade, many methods using magnetic beads (CellSearch), filtration (RareCelletc), or flow     cytometry have been developed but all of them have the shortcomings from low sensitivity, low     purity, to unable to retrieve cells for downstream molecular analysis and cell culture.     Recently, a biomimetic affinity based microfluidic platform has overcome abovementioned     technical challenges. Importantly, by using only 2 ml of peripheral blood, Sinica's team has     shown that the enumeration of CTCs increases with the CRC disease progression, where the mean     CTC counts are 3, 15, 29 and 60 per ml for the stages I, II, III and IV, respectively. The     results imply that monitoring CTC enumeration serially may serve as a prediction marker to     identify the CRC patients with high probability of recurrence. The aims of this study are     toestablishing CTC platform standard operation protocol (SOP) that leads to certification of     ISO 13485 and to establish CTC criteria and evaluate its prediction power of early detection     of colorectal cancer recurrence.   "
97811|NCT02005900|"     Highly active antiretroviral therapy (HAART) is able to cause lipid metabolism and glucose     homeostasis alterations, which are associated to the redistribution of body fat. Alterations     in lipid and carbohydrate metabolism contribute to the development of a highly atherogenic     profile, which together with altered fibrinolysis markers and increased presence of     proinflammatory cytokines in blood (especially tumor necrosis factor alpha) that comes     associated to the success of HAART can cause the development of accelerated atherosclerosis.     Docosahexaenoic acid (DHA) is a polyunsaturated fatty acid that has demonstrated its ability     to reduce triglyceride levels; modify cholesterol fractions and increase the size of LDL     particles thereby configuring less atherogenic plasma profile. Additionally, administration     of DHA has shown antiinflammatory and hypotensive activity, which contributes to reduce the     risk of cardiovascular complications in these patients. At a molecular level, DHA acts as a     stimulator of the nuclear receptor PPAR-gamma, which has been described to induce an increase     in adipocyte differentiation. Furthermore, the anti-inflammatory effects induced by DHA, can     decrease the elevated levels of TNF-alpha, which has been implicated in the pathogenesis of     body fat redistribution in HIV infected patients undergoing HAART. Therefore, the hypothesis     of this project is that DHA will be able to produce lipid-lowering, anti-inflammatory,     hypotensive and profibrinolytic effects, which all together should improve atherogenic     profile of patients with HIV-1 infection receiving HAART. In addition, their proprieties as     PPAR agonist can improve the redistribution of body fat present in many of these patients.     The study of the activity of DHA on dendritic cells and monocytes should indicate the absence     of immunosuppressive effect of DHA in the context of HIV-1 infection.      In summary, DHA is a natural product, from the omega 3 polyunsaturated fatty acids, the     therapeutic properties of which have been described in recent years and has shown     cardio-vascular and metabolic beneficial effects, without recognized side effects. The highly     purified DHA administration at high doses could be able to reverse, at least partially, lipid     abnormalities associated with HAART and to exert a beneficial effect on fat redistribution in     HIV-infected patients treated with HAART. To ensure non deleterious immunological treat in     these sensitive poly-medicated patients, substantial changes in the functionality of     dendritic cells and monocytic will be studied.   "
97812|NCT02005887|"     The purpose of the this study is to investigate the anti-tumor activity and tolerability of     the study medications Degarelix and Triptorelin in premenopausal women receiving preoperative     treatment with Letrozole.   "
97813|NCT02005874|"     The purpose of the study is to collect valuable data on the role of controlled humidity,     temperature, airflow, and visual tasking in altering the tear film protein composition. The     results from this preliminary study will help to explore the role of tear film markers in     inflammatory and disease conditions. This can also be extended to understand the role of the     tear film in protecting the ocular surface when individuals are exposed to low humidity     environments which may incite discomfort symptoms.   "
97814|NCT02005861|"     BACKGROUND Osteochondral lesions are defects of the cartilaginous surface and underlying     subchondral bone of the talar dome.      The use of concentrated bone marrow derived cells has been gaining successful results with     arthroscopic implantation, since it is possible to transplant not only mesenchymal stem cells     but also accessory cells that support angiogenesis and vasculogenesis by producing several     growth factors.      OBJECTIVES Objective of this project is to identify the critical points of the regenerative     treatment of osteochondral lesions of the ankle, in order to develop a standard and     predictable procedure able to overcome the drawbacks of the previous techniques.      METHODS Our program is to evaluate and follow 140 new patients with focal osteochondral     lesion of the talus. The surgical procedure will be executed as following: the day before the     surgery the platelet gel will be produced. The day of the surgery bone marrow will be     aspirate from the posterior iliac crest and concentrated directly in the operating room by     centrifugation, in order to obtain 6 mL of concentrate containing nucleated cells.      Then a standard ankle arthroscopy will be performed. The scaffold will be loaded with 2 ml of     bone marrow concentrate and cut into an appropriate shape.      After the scaffold implantation platelet gel will be sprayed on the top of implant, in order     to provide extra growth factors and to improve the stability of the implant.      All patients will be examined clinically preoperatively, at 3, 6, 12, 24 and 36 months and at     maximum follow-up. Different score scales will be used to objectivate the clinical results     (AOFAS, SF-36, VAS). X-rays and MRI scan will be also taken preoperatively, and MRI will be     executed at 12, 24 and 36 months of follow-up. In particular, a new qualitative MRI called T2     mapping will be performed at 24 months.      EXPECTED RESULTS We expect to highlight the effectiveness of the arthroscopic bone marrow     derived cells (BMDCs) transplantation in a long term follow up study, with particular     attention to identify the patient population that can gain the maximum benefit from this     treatment, avoiding expensive and unnecessary procedures that too often are performed.   "
97834|NCT02005601|"     We are investigating the impact of duloxetine (Cymbalta), a serotonin and norepinephrine     reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the     investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores     2 weeks after TKA.   "
97821|NCT02005770|"     Serious concern about the role of anesthesia in tumor recurrence has considerably risen over     years, but the lack of surrogate markers for tumor spreading made trials addressing this     issue difficult to realize. In breast cancer patients CTC positivity has been recently     recognized as an independent prognostic factor. In this respect, we postulated that in a     first step changes in the number of CTC after general anesthesia would help to determine the     effect of anesthesia on this tumor marker.   "
97822|NCT02005757|"     The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and     50mg tid in active rheumatoid arthritis patients unsuccessfully treated with     disease-modifying antirheumatic drug.   "
97823|NCT02005744|"     The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with     impaired hepatic function compared with normal hepatic function.   "
97824|NCT02005731|"     This is a prospective, pilot study for assessing the safety and efficacy of the treatments     performed with Renova (LI-ESWT) on symptomatic ED patients.   "
97825|NCT02005718|"     Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial     dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated     the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.   "
97826|NCT02005705|"     Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow     Blatchford score of zero will be randomly assigned to further care in the inpatient vs.     outpatient setting. The hypothesis of this study is that patients who are managed as     outpatients will require interventions at a rate not higher than those managed as inpatients     and will have lower direct healthcare costs.   "
97827|NCT02005692|"     The study is designed to test the DynaSense system, which is a patient movement and     orientation monitoring system. The study is intended to determine that:        -  the DynaSense system identifies patients that are not turning adequately on their own          and therefore require caregiver-assisted turns.        -  the DynaSense system identifies patients that are turning adequately on their own and          therefore do not require a caregiver-assisted turn.        -  the DynaSense system helps ensure compliance with an institution's established patient          turning protocol.   "
97842|NCT02005497|"     The proposed project will answer key questions about implementing evidence-based health     promotion interventions at small and low-wage worksites. Small, low-wage worksites will be     randomized to receive HealthLinks (a free American Cancer Society program to disseminate     evidence-based interventions), HealthLinks+ (which will include creating worksite wellness     committees as part of the program), or to serve in a delayed control group. This approach     will identify successful strategies for implementing evidence-based interventions at low-wage     worksites to improve workers' cancer screening, healthy eating, physical activity, and     tobacco cessation.   "
97828|NCT02005679|"     In France the prevalence of pre-lingual deafness is between 1 and 1.4 per 1000 habitants, and     according to very conservative estimates, about 44 000 deaf persons use the sign language.     Additionally, the prevalence of dementia in France is close to 1% (850 000 dements for a     total population of 65 millions). The prevalence of dementia in pre-lingual deaf adults has     also been described and is between 1 and 1.4 /100 000 habitants.      The Mini Mental State Examination (MMSE) of Folstein is a test recommended to perform the     cognitive evaluation for the detection of mental disorders including dementia, and a     consensual French version exists prepared by GRECO (Group of Research and Cognitive     Assessments). However, to date, there are no simple, rapid and validated screening tests to     study cognitive disorders in deaf persons who use the sign language. The only tests available     allow a late diagnosis avoiding an optimal treatment of the patients.   "
97829|NCT02005666|"     This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo     Controlled, Three Arm Clinical Study.      The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate     1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of     Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo     respectively.      Total study duration will be for a period of 78 days which includes treatment duration of 77     days.      850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria     mentioned in the protocol.   "
97830|NCT02005653|"     Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as     standard treatment for the clearance of W. bancrofti infection. It takes about one year for     the individuals to completely clear the microfilaria from the blood. It takes another two to     four years to clear the antigen. The aim of the present study is to shorten the time taken     for clearing the Mf and antigen from the blood either by co-administration or sequential     administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a     randomized, double blind, controlled clinical trial to study the efficacy of these drug     combinations in complete clearance the Mf and antigen from the blood in shorter span of 180     days and 365 days respectively.   "
97831|NCT02005640|"     The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus     TEE) in transcatheter aortic valve implantation on the prevalence and severity of     paravalvular regurgitation.   "
97832|NCT02005627|"     About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the     nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the     eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts for     approximately 7 times more doctors' appointments than asthma. The standard treatment for hay     fever consists of treating the symptoms with a nasal spray and an antihistamine. However, in     a survey taken in a UK general practice less than 40% of patients with hay fever reported     good symptom control with this standard treatment. For those patients with hay fever whose     symptoms are not well controlled by treatment with antihistamines and nasal sprays,     subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract for a     period of 3-5 years) is an effective alternative, and is approved in the UK on a named     patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed,     including grass pollen allergen tablets. These have been shown to be highly effective in the     treatment of hay fever, with the additional benefit of being convenient for patients, given     that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium København     (ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the treatment of     troublesome grass pollen induced hay fever. The aim of this research is to investigate the     effects of the AIT treatment on the immune system over time - which changes are taking place     and when in the course of treatment. This will provide insight into the complexities of the     development of allergen-specific immune tolerance - how harmful allergic responses against     innocuous substances such as grass pollen can be overridden.   "
97833|NCT02005614|"     The purpose of this study is to collect prospective data for use as a comparator for future     subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife     radiosurgery.   "
97837|NCT02005562|"     This study will compare the incidence of acute clinical or subclinical rejection between     immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug     monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in     kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and     early discontinuation of steroids. Patients will be randomized to one of the two treatment     arms. The anticipated time on study treatment is 52 weeks.   "
97838|NCT02005549|"     This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and     Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will     be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time     on study treatment is 3-12 months.   "
97839|NCT02005536|"     The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive     Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.      Primary Objective:        -  To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one          month following the vaccination dose with SP059 as 2nd booster      Secondary Objectives:        -  To investigate seroprotection rates (percentage of subjects presenting poliovirus          neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points,          Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of          individual titer ratio (GMTR).        -  To investigate the safety after dosing of SP059 as 2nd booster.   "
97840|NCT02005523|"     The purpose of this study is to see if use of RNS60 during hip labral repair surgery     decreases pain and improves functional capacity post-operation.   "
97841|NCT02005510|"     The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV)     screening kits is effective in increasing uptake of cervical cancer screening and early     detection and treatment of cervical neoplasia in underscreened women.   "
97843|NCT02005484|"     This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or     advanced gastric cancer with disease progression during platinum-based or     5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until     disease progression.   "
97844|NCT02005471|"     This is an open-label, multicenter, randomized, Phase III study to investigate the efficacy     and safety of venetoclax in combination with rituximab (venetoclax+R) compared with     bendamustine in combination with rituximab (BR) in participants with relapsed or refractory     chronic lymphocytic leukemia (CLL). Participants will be randomly assigned in 1:1 to receive     either venetoclax+R (Arm A) or BR (Arm B).   "
97845|NCT02005458|"     This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and     safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia   "
97846|NCT02005445|"     This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for     obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including     impact on exercise capacity, disability, and quality of life.   "
97847|NCT02005432|"     Objectives:      Primary objective:      To evaluate the effects on retinal morphophysiology of full scatter single target panretinal     photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both     combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR)     alone in patients with proliferative diabetic retinopathy (PDR).      Primary outcome:      The primary endpoint for this study is the mean change in the total area of active retinal     neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to     week 48.      Secondary objectives:        -  To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in          central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and          oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on          the peripheral visual field by static perimetry (30:2 strategy), from baseline to week          48.        -  To assess the incidence of adverse events during the study.      Strategic goal:      In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to     determine what would be the best association of PRP + anti-VEGF for proliferative diabetic     retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better     regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG     response and visual field).   "
97848|NCT02005419|"     Pancreatic cancer represents the most lethal of the common malignancies with a 5-year     survival rate of less than 5%. For patients who are eligible for potentially curative     resection, despite mortality and morbidity rates after surgery have improved, the recurrence     rate is up to 85% within 2 years. Data from clinical trials indicate that adjuvant     chemotherapy enhances 5-year survival to ~25% for patients who have undergone surgery to     remove their tumor; and gemcitabine is the standard regimen of chemotherapy. Metformin is the     first-line treatment for type 2 diabetes mellitus. Literatures reported that metformin might     inhibit tumor growth by blocking some enzymes needed for cell growth. Some retrospective     studies have revealed that diabetic patients taking metformin were less likely to develop     pancreatic cancer. Additionally, pancreatic cancer patients treated with metformin showed a     better survival than those without metformin. In this study, the researchers intend to     investigate the activity and safety of the combination of gemcitabine and metformin in     treating patients with pancreatic cancer that have removed by surgery.   "
97849|NCT02005406|"     Testing the efficacy and safety of the WEI Nasal Jet.   "
97850|NCT02005393|"     The study is intended to test the image quality of the FICE system to the predicate device,     Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.   "
98024|NCT02003118|"     This proof of concept study will be a placebo controlled, randomised, double blind, parallel     study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of     osteoarthritis (OA) pain in the knee.   "
97851|NCT02005380|"     The focus of this work is to explore the use of modern mobile technology to enable people     with Alzheimer's disease to improve their abilities to perform activities of daily living and     hence to promote independence and participation in social activities. This work also aims at     reducing the burden on caregivers by increasing the AD patients' sense of competence and     ability to handle behavior problems.   "
97852|NCT02005367|"     A person-centered substance use treatment component, the Natural Recovery Program, was     developed in a residential substance use treatment setting. The Natural Recovery Program is     comprised of small group therapy combined with pursuit of hobbies. The study examined     treatment retention, treatment completion and satisfaction of participants of Natural     Recovery compared to those who participated in core residential treatment activities alone.   "
97853|NCT02005354|"     The approach of this study will be to answer the question does high-frequency stimulation     Trans-Cutaneous Electrical Nerve Stimulation (TENS) alleviate the pain experienced during the     bone marrow sampling procedure in addition to the standard analgesia given (ie. local     anaesthetic with or without inhaled nitrous oxide).      Null hypothesis: TENS does not alleviate the pain experienced during the bone marrow sampling     procedure in addition to the standard analgesia given   "
97854|NCT02005341|"     The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler   "
97855|NCT02005328|"     The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability     of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia     associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation     (hyposialia) induced by chronic drug intake.   "
97856|NCT02005315|"     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and     PK of vantictumab when combined with nab-paclitaxel and gemcitabine.   "
97857|NCT02005302|"     Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness     of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet     treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.   "
97873|NCT02005094|"     1. To investigate the inflammasome response of inflammatory and resting macrophage derived          from healthy human participants by stimulation using MAC or MAB bacilli.        2. To compare the difference of inflammasome response of inflammatory macrophage by MAC/MAB          bacilli stimulation between MAC/MAB-LD patients and the colonizers.        3. To study the diagnostic aid from immunological markers in inflammasome response in          inflammatory macrophage stimulated by MAC/MAB.   "
97858|NCT02005289|"     This phase II trial studies how well anti-cluster of differentiation (CD)19 monoclonal     antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or     previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma, or     prolymphocytic leukemia. Monoclonal antibodies, such as anti-CD19 monoclonal antibody     MOR00208, can block cancer growth in different ways. Some block the ability of cancer to grow     and spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Giving anti-CD19 monoclonal antibody     MOR00208 and lenalidomide may kill more cancer cells.   "
97859|NCT02005276|"     Employers are increasingly looking for opportunities to motivate sedentary employees to     become more physically active. Workplace walking programs have had mixed success and     typically show most improvement among participants that are already fairly active at a     baseline. The goal of this study is to determine whether a financial incentive program can     motivate sedentary employees to increase the number of steps they walk per day to meet a     minimum threshold.      Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or     more is achieved. We will assess outcomes each week for 3 months using incentives followed by     3 months of follow-up without incentives. Secondary outcomes will include the average steps     walked per day.   "
97860|NCT02005263|"     Disease of the fallopian tubes is one of the most common reasons for infertility. The most     common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses     concurrent uterine disease. We propose using a less painful technique (through modified     office hysteroscopy) for tubal assessment that can be performed in the office rather than     hospital radiology and that uses gold standard technology for identifying coexisting uterine     conditions.   "
97861|NCT02005250|"     The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and     one year after treatment for a thyroid functional disorder   "
97862|NCT02005237|"     Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there     are no available treatments to improve cognition in this patient population. Some evidence     from animal studies and small clinical trials suggest that aerobic exercise might     beneficially affect cognitive function in MS. The aim of this randomized-controlled trial is     to explore if an aerobic exercise training program can enhance cognition in MS. In addition,     we will employ neuroimaging markers to determine if exercise alters measures of brain     structure and function.      Patients will be randomly assigned to either a 3-months exercise program (bicycle ergometry,     2-3 session per week) or a waitlist control group. The primary endpoint of the study is a     test of verbal learning and memory. Secondary endpoints include neuroimaging markers of     functional and structural connectivity in the brain. We hypothesize that exercise will     improve verbal learning and memory and beneficially affect measures of brain connectivity.   "
97863|NCT02005224|"     Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on     bout of exercise in combination with either a normal diet or a LCHF diet, in relation to     glucose metabolism, insulin sensitivity, lipid profile and body composition.   "
97864|NCT02005211|"     This study consists of two parts, ie, single dose part with young healthy subjects (Part 1)     and single and multiple dose part with elderly healthy subjects (Part 2), to assess the     safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and     multiple ascending dose administration to healthy subjects.   "
97865|NCT02005198|"     This study is conducted in the United States of America (USA). The aim of the study is to     assess the minimal important difference (MID) of the TRIM-AGHD.   "
97866|NCT02005185|"     Anesthesia for more than 120 minutes given to children less than 2 years of age without     coexisting diseases of the central nervous system or the heart cause long-term impairment of     recognition memory.   "
98025|NCT02003092|"     The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902     identified in the phase 1 to treat subjects with triple negative breast cancer.   "
97867|NCT02005172|"     In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14     day event monitor with the use of both devices simultaneously. We will also examine by means     of a questionnaire the compliance, ease of use and patient satisfaction for each device.      Hypothesis:        1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to          diagnosis of the arrhythmia responsible for a patient's symptoms.        2. The AliveCor monitor will have better compliance and acceptability compared to the 14          day event monitor, and thus there will be a greater number of days with recordings from          the AliveCor monitor.   "
97868|NCT02005159|"     Provide scientific and validated data to help International Authorities to set susceptible to     antibiotics cut-off points in bacteremia by Enterobacteriaceae   "
97869|NCT02005146|"     Define the patients who lost HBsAg, studying the loss predictive factors and if there was     suspension of treatment, study the evolution after that   "
97870|NCT02005133|"     To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior     treated wet AMD patients managed in 'real wold' clinic settings.   "
97871|NCT02005120|"     Malignant pleural effusion (MPE) is a common complication of advanced non-small cell lung     cancer (NSCLC). Bevacizumab, a humanized monoclonal antibody against vascular endothelial     growth factor (VEGF), has been shown to be efficient in suppressing the accumulation of     pleural fluid. The other widely used treatment for MPE is recombinant human endostatin.   "
97872|NCT02005107|"     This study is being conducted to evaluate how the body absorbs and processes the immediate     release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are     1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate.     Non-surgical controls will also be enrolled based on a matching criteria to post gastric     bypass subjects. Participants will be asked to complete two 12-hour study days approximately     11 days apart. This study will enroll up to 30 participants.   "
97874|NCT02005081|"     The purpose of this single-center, prospective, randomized study is to determine the fusion     rates along with the clinical outcomes of commercially available bone graft substitutes     Actifuse mixed with bone marrow aspirate (BMA) versus autograft mixed with demineralized bone     matrix (DBM), in subjects who require anterior cervical corpectomy (ACC) spinal fusion in     patients experiencing cervical spondylotic myelopathy (CSM).   "
97877|NCT02005042|"     Lack of physical activity is associated with negative health outcomes, including obesity,     diabetes, and cardiovascular disease. There are calls from NIH and medical organizations to     integrate the use mobile devices, such as smartphones, to provide e-health interventions to     patients in their daily life. Referred to as Ecological Momentary Interventions [EMI], these     innovative mobile methods provide an opportunity for researchers and clinicians to offer     tailored intervention material to people at specific times and in specific settings when they     may be most in need of such support. To our knowledge no study has used objective ambulatory     assessment data to deliver EMI. This preliminary work is to demonstrate the feasibility, and     test preliminary efficacy, of using a Bluetooth accelerometer to provide real-time feedback     on a smartphone to increase objectively measured steps (i.e., increase activity). A     within-person design will be used, including assessment, intervention, and follow-up phases.     During the assessment phase objective physical activity (using accelerometers) will be     collected. In the intervention phase participants will also receive real-time feedback     throughout the day regarding their total steps and personalized step goals. Objectively     measured steps and disease status measures will be used to evaluate efficacy.   "
97878|NCT02005029|"     Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa     (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse.     Gastroparesis effects how the levodopa is absorbed and used by the body. This study will     explore the possibility of using Erythromycin, a drug commonly used (off label) for     gastroparesis, along with levodopa to determine if there is improved levodopa absorption and     motor function.   "
97879|NCT02005016|"     This study examines aphasia treatment response among Veterans and non-Veterans living with     aphasia. It seeks to identify cognitive and neural factors which are predictive of positive     response to treatment targeting naming impairments in aphasia. It also examines the     dose-response relationship for naming treatment. More broadly, it seeks to determine who     aphasia therapy works best for, and how much aphasia therapy is sufficient to achieve     positive treatment response.   "
97880|NCT02005003|"     To examine the cognitive and metabolic effects of a probiotic supplement that is readily and     already available for purchase in public drug stores. This study is a double-blinded     randomized cross-over placebo-controlled intervention study. Participants will be randomized     to receive either the probiotic supplement or the placebo during the first intervention     period which will last 2 weeks. This will be followed by a washout period, after which they     will proceed to the second intervention period, also lasting 2 weeks and also followed by a     washout period.   "
97899|NCT02004756|"     Primary Objective: To determine if impairments in cardiac and musculoskeletal function and     metabolism exist in Fontan children.      Secondary Objectives:        1. To determine if impairments do exist, are they related to exercise capacity.        2. To determine if a 12-week exercise training intervention improves cardiac and/or          musculoskeletal metabolism.      Hypothesis: The investigators hypothesize that abnormalities in cardiac and skeletal function     are evident, influence exercise capacity, and can be improved with exercise training.   "
97881|NCT02004990|"     The overall goal of this study is to improve the standard of care in treating young children     who often suffer from chronic caries (dental decay). Current standard of care for children     under 12 years old includes a dental cleaning and fluoride treatment. Often this dental     cleaning includes a 'dental prophylaxis' with a pumice based paste delivered by a small     rubber-like cup that rotates on a slow-speed dental handpiece. The procedure of this dental     prophylaxis removes the gross levels of plaque around the supragingival tooth surfaces. After     this prophylaxis, a fluoride treatment is delivered. The National Maternal and Child Oral     Health Resource Center at Georgetown University has published (Bertness J, Holt K) an     extensive publication proving that 5% sodium fluoride varnish has become the 'standard of     care' for fluoride treatment in children. This study includes this fluoride standard of care.      Prior to the administration of this standard of care fluoride treatment, a separate step of     cleansing the tooth after the dental prophylaxis is added. This study uses a cleansing     procedure of 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.      The primary aims of this study are:        1. to measure the changes in overall plaque levels after using a 10% povidone iodine (PI)          cleansing prior to fluoride varnish (FV) application.        2. to measure the short term changes in the oral microbial ecology of dental plaque after          10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.   "
97882|NCT02004977|"     The goals of this intervention study are to implement best practice strategies to expand and     promote the school breakfast program and test the impact upon student participation rates     among a) all 10th and 11th grade students and among a randomly selected cohort of 800     students b) total diet and body mass index and percent body fat inin 16 rural Minnesota     school districts.      School-wide Primary Aim: Improve participation in the school breakfast program among high     school students. Hypothesis: School-wide school breakfast program participation will be     higher in the intervention versus comparison group.   "
97883|NCT02004964|"     Protocol to screen potential subjects for islet transplantation   "
97884|NCT02004951|"     Over the past years, endovascular interventions have become an important part of treatment in     patients with peripheral arterial disease.1 Indication for endovascular repair of     femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1     Enlargement of endovascular therapy indication was based on patient choice for a less     invasive technique and evidence based medicine. Consequently, TASC classification of lesions     has been modified to reflect increased evidence for endovascular treatment of more extensive     femoropopliteal lesions, and indication for endovascular repair has been enlarged to more     severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions     which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the     interventionalists have at their disposal a huge tool box. Evaluation of these tools is     crucial to determine the right treatment strategy to avoid further reinterventions and     overcosts.      The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent     (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of above-the-knee     intermediate length femoropopliteal lesions.      From hospitals in Europe (France, Switzerland) we will randomly assign patients with     symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent     or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).   "
97885|NCT02004938|"     Project Aims: The purpose of this study is to determine the size of the right internal     jugular vein (RIJV) in children with normal respiratory physiology during the respiratory     cycle and evaluate the reliability of those measurements.      Hypothesis: Ultrasound measurements of internal jugular vein collapse of children can be     reliably measured in the respiratory cycle.      Intervention: We will ensure that the patient is not having any respiratory symptoms or signs     of dehydration. A clinical asthma score will be assigned using the Modified Woods pulmonary     index scoring system. The Gorelick Dehydration Scale with also be calculated.      Using bedside ultrasonography with the Sonosite Titan ultrasound machine, each measurement     will be taken with the subject lying in bed with the head of the bed elevated at 45 degrees     with the subject's head in the neutral position and then turned 45 degrees leftward.     Measurements of the internal jugular vein at maximal inhalation and exhalation will be     recorded. Reliability calculations will be assessed.   "
97886|NCT02004925|"     Pneumoperitoneum could be due to life threatening conditions and its quickly diagnosis is     important in the emergency department (ED). Signs and symptoms are non-specific and     radiography has low accuracy in the acute setting. Computed tomography (CT) is considered the     gold standard, however it is not a cost-effective option in the vast population of patients     with abdominal pain. Ultrasonography is able to detect as little as 2 ml of free air, however     diagnostic accuracy of ultrasonography remains unclear. This study evaluates the accuracy of     ultrasonography for the diagnosis of pneumoperitoneum, the most accurate abdominal scan and     the most accurate echographic sign for the detection of free air.      Methods Consecutive patients presenting to ED for acute abdominal pain and with a diagnosis     of pneumoperitoneum at CT or at surgery (study group) and a similar number of patients     without a diagnosis of pneumoperitoneum (control group) undergo abdominal ultrasonography in     a standardized protocol that include 10 scans for each patient registered on a video of 5     seconds. The videos are randomly reviewed by 4 sonographers and by 2 physicians with no     experience in ultrasonography blind to final diagnosis and to all clinical data with the aim     of detecting for each scan pneumoperitoneum. Accuracy of ultrasonography for the diagnosis of     pneumoperitoneum will be calculated considering CT or surgery as gold standard. Furthermore     intra and interobserver agreement and the accuracy of each ultrasonographic sign and scan     will be calculated.   "
97887|NCT02004912|"     Our hypothesis is that an on-site mentoring program for staff at primary health care centers     in northern Karnataka, will improve the quality of maternal, neonatal and child health care,     and improve clinical outcomes.   "
97959|NCT02003963|"     The purpose is to evaluate the feasibility of a 12-week exergaming dance program for     adolescent girls. This study combines dancing, video games, and a full body work-out to test     if video games can increase physical activity and promote healthy weight in adolescent girls.     We hypothesize that girls who play the dance exergames, versus those in the control group,     will lose weight, decrease body fat and visceral fat, improve cardiovascular health, increase     physical activity, and improve psychosocial health including self-confidence and quality of     life.   "
97888|NCT02004899|"     Epidural analgesia is the most effective form of labor pain relief. Low doses of local     anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as     epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids     for labor have been shown to decrease motor block (leg weakness or temporary paralysis),     without affecting labor pain relief. However, onset of pain relief can be delayed with these     low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose of     local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain     relief.      There is some evidence that the addition of more fentanyl to the epidural bolus dose of     bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both     medications are safe for you and your baby.      This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50     mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief.      The study hypothesis is that the onset of epidural labor analgesia will be shortest with the     larger fentanyl epidural bolus.   "
97889|NCT02004886|"     This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in     participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will     reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.   "
97890|NCT02004873|"     The purpose of this clinical study is to evaluate the safety and efficacy of the Micra     Transcatheter Pacing System and to assess long term performance.   "
97891|NCT02004860|"     Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses,     affecting mainly the face and scalp. It would be important to have a maintenance treatment     for severe forms of seborrheic dermatitis witch is both effective and relatively well     tolerated to reduce the frequency of relapses, prolong remissions obtained after attack     treatment and reduce the use of topical steroids.   "
97892|NCT02004847|"     The purpose of this study is to determine the efficacy and safety of a blue light device for     treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an     untreated control plaque. Additionally, two intensities of blue light are compared.   "
97893|NCT02004834|"     The purpose and the goal of this paper is to show whether the application of a combination of     two local anesthetics, as opposed to the application of one local anesthetic at paravertebral     block changes the hemodynamic variable. It is therefore a prospective randomized double-     blind study, where we do a clinical trial in patients ASA(American Society of     Anesthesiologists) 1 and 2 statuses between 18 and 80 years of age, using the ultrasound in     plane technology.Upon arrival of patients in the unit for preparation procedures for     anesthesia we set the ECG(electrocardiograph), noninvasive blood pressure, oxygen saturation,     and arterial cannula in the radial artery After sterile washing of the dorsal surface,     paravertebral space was identified with ultrasound using 8 Hz(hertz) linear transducer probe     then needle position was confirmed with neurostimulation at the level of 2.0 - 5.0     mA(milliampere). When muscle contraction persisted at 0.4mA(milliampere), the anesthetic was     applied in levels of Th 2, Th3, and Th 4 (7,0 milliliters per level). We applied the 0.5 %     levobupivacaine and 2 % lidocaine, 7,0 milliliters of mixture per level in one group, while     only 0.5 % levobupivacaine also 7,0 milliliters. by level in the second one. After that, the     invasive hemodynamic monitoring was placed on patients and the induction with 1 % propofol     2-2.5 mg/kg.and Vecuronium 0,08 mg/kg. was performed with the application of supraglottic     airway gel of appropriate size. The maintenance of anesthesia and sedation will be conducted     with Propofol 1 % continuously ( 25-150 mcg / kg / min.)The measurements will be taken every     5 minutes during the first hour of the application of paravertebral block, then every 15     minutes during the second hour and if the operation takes more than two hours, the     measurements are performed every 30 minutes. Postoperatively, invasive hemodynamic monitoring     will be removed in post-anesthesia recovery room together with the arterial cannula and the     patient will be sent to the hospital ward with non-invasive hemodynamic monitoring (blood     pressure, pulse, saturation) until the termination of the blocks.Statistical methods, By     comparing two target groups, we analysed the strength of the test with following assumptions:     X2 difference test, the expected difference in variances in stroke volume between groups of     60%, α significance level of 0.05, and the minimum statistical test strength of 85%. The     required total sample should include at least 80 patients, that is, 40 per group.Data will be     presented in tables and graphs. Descriptive statistics of examined variables with appropriate     measures of central tendency will be made. Smirnov -Kolmogorov test will assess the normality     of data distribution. According to the received results, the appropriate parametric and / or     nonparametric tests will be used. Comparisons of quantitative values between the two groups     will be analyzed using the independent t-test or Mann-Whitney U test. Dependent values within     each group will be analyzed using analysis of variance for repeated measures or Friedman     test. Differences in categorical values will be analyzed by X2 test. The appropriate     regression model will be made in order to predict the variability of stroke volume in which     the dependent variable will be a variation of the stroke volume, while relevant clinical     values will be taken as predictor variables. All P values smaller than 0.05 will be     considered significant.      This research is to present the main results - the existence of the significant change in     Stroke Volume Variation (SVV) between groups using invasive hemodynamic monitoring, the     changes of Stroke Volume Variation(SVV) depending on the time from the application within     groups, differences in volume compensation of crystalloids and colloids and the need for the     application of vasoactive drugs. Furthermore, as a secondary results we will present the time     to maximal block development, the duration of post operative analgesia, patient satisfaction     and time needed for the full recovery from the block.   "
97894|NCT02004821|"     The purpose of this study is to evaluate the molecular differences between a group of     Constitutionally Thin (CT) subjects and a group of controls.   "
97895|NCT02004808|"     NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea     treatment.The study hypothesis is that NETs formation by neutrophils has a role in the     induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte     count in children with sickle cell anemia is a bad prognostic sign due to NETs formation     supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might     prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil     count and inhibiting NETs formation.   "
97932|NCT02004327|"     1. Objective After single dose in healthy adults the capacity of the Group for DW1029M          evaluate the pharmacokinetic characteristics.        2. Indication Diabetic kidney disease        3. Efficacy             1. Primary                  -  AUClast, AUCinf, AUClast/D, AUCinf/D                  -  Cmax, Cmax/D             2. Secondary                  -  Tmax, t1/2, CL/F, Vz/F        4. Safety             1. Adverse Event Monitoring             2. V/S, EKG, Laboratory Test, P/E   "
97896|NCT02004795|"     This is a boron neutron capture therapy (BNCT) combined with image-guided intensity     modulation radiotherapy (IG-IMRT) for patients with previously irradiated and locally     recurrent head and neck cancer. The primary end points are treatment toxicities and response     rate. The secondary endpoints are time to tumor progression, progression-free survival,     overall survival and change quality of life.      Head and neck(H & N) carcinomas that recur locally after conventional irradiation pose a     therapeutic challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture     reaction that occurs when non-radioactive boron is irradiated with neutrons of thermal energy     to yield high energy alpha particles and recoiling lithium nuclei. The effect of alpha and     7Li is primarily limited to boron-containing cells. Preferential uptake of boron into     cancerous tissue is achieved using boron carriers such as a derivative of phenylalanine,     boronophenylalanine (BPA). After administration of BPA by intravenous infusion, the tumor     site is irradiated with neutrons, the source of which is currently a nuclear reactor, like     the Tsing Hua Open-Pool Reactor (THOR), a 2MW research reactor at National Tsing Hua     University (NTHU) in Taiwan. Since it is a target radiotherapy, low complication rate after     BNCT can be obtained. However, further local recurrence after BNCT for recurrent H & N cancer     was reported in several publications.      Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional     imaging, during a course of radiation treatment, used to direct radiation therapy utilizing     the imaging coordinates of the approved radiation treatment plan. IGRT such as Cone-Beam CT     (CBCT) using an On-Board Imager (OBI) enhance delivery and further improve outcomes as the     treatments create a higher level of precision. By combining BNCT and IG-IMRT, we expect to     procure high control rate of recurrent H & N cancer with acceptable toxicity. This study will     be the first BNCT plus IG-IMRT trial to treat head and neck cancer in Taiwan.   "
97897|NCT02004782|"     Barretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer.     Oesophageal cancer is aggressive, with a 5 year survival of only ~15%. High risk Barretts     mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic mucosal     resection (EMR) during gastroscopy. If patients can be effectively treated by EMR while they     have premalignant or early malignant disease, it is a curative procedure.      Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue     development in the oesophagus, leading to stricture formation and difficulty swallowing     (dysphagia). If a safe and effective method could be found to reduce this risk, the treatment     options for early oesophageal cancer would be greatly improved. CBE is performed as a two     stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised, doubleblind study,     eligible and enrolled patients are randomised after the 1st stage CBE to receive either     prednisolone tablets or placebo. Inclusion criteria are patients with short segment (<3cm     circumferential disease) Barretts oesophagus with high grade dysplasia or early cancer. The     treatment period is for 6 weeks after both CBE sessions. Prednisolone is given in a reducing     dose over the 6 weeks, starting at 40mg daily.      The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be     performed as required for dysphagia secondary to symptomatic oesophageal stricture formation     persisting for ≥2 days, or complete dysphagia for any time period. Endoscopic surveillance     with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to     assess for complete removal of Barretts mucosa.      Following two stage CBE, stricture rates without preemptive therapy in noncircumferential,     circumferential <2cm, and circumferential <3cm disease, are estimated to be 30%, 50% and 70%     respectively. The investigators predict a 50% reduction in stricture rate with oral steroid     therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of     significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop     out rate, a total of 126 patients are required. The study will be performed at five     Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.   "
97898|NCT02004769|"     Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic     gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease     are to be recruited in the study. In the current study, the efficacy and safety of     Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients     with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate     precision rather than controlling type I&II error. Assuming the target PFS is 6.7m, 60     patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will     be enrolled.   "
97984|NCT02003638|"     This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and     favorably affect circulating levels of endothelial progenitor cells and microparticles in     people with atherosclerotic disease on chronic statin therapy.   "
97900|NCT02004743|"     Sunnybrook Health Sciences Centre is Canada's largest trauma centre, treating 1,100 patients     annually. A traumatic experience can lead to post-traumatic stress disorder, which increases     hospital stays, emergency visits and disability. Despite developing leadership to manage a     Code Orange mass trauma, Sunnybrook lacks guidelines in the psychological management of     patients who have experienced trauma. The department of psychiatry currently holds a     Traumatic Brain Injury clinic and PTSD services for youth but lacks both immediate     intervention, prevention and adult services. This research will enable us to gain best     evidence expertise to develop guidelines as well as a sustainable PTSD treatment program,     with clear outcomes to assess effectiveness, psychiatric morbidity, use of healthcare,     disability and substance abuse.      The five world-expert-consensus intervention resilience based principles will be     operationalized in guidelines for the management of trauma patients, their caregivers and in     routine nursing and trauma team care from the Emergency to the ward, and discharge, through     to outpatient care. It is hypothesized that this will improve the psychological recovery of     patients at risk of developing PTSD after a traumatic injury. In addition, early screening     and intervention for increased risk of PTSD will be implemented one month after the trauma.     It is hypothesized that such trauma informed psychological management, early screening and     expert treatment using prolonged exposure will reduce hospital stays, functional disability,     as well as longer-term psychiatric morbidity, including substance abuse.   "
97901|NCT02004730|"     The purpose of this study is to determine whether patients with diffuse or multivessel     coronary artery disease may benefit from the percutaneous implantation of the device ABSORB     in larger extent with respect to the general population of patients undergoing percutaneous     treatment of coronary artery disease.   "
97902|NCT02004717|"     This is an open-label, sequential dose escalation and expansion study to evaluate the safety,     tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid     tumors.   "
97903|NCT02004704|"     The primary objective of this study is to obtain data regarding the safety of olipudase alfa     in patients with acid sphingomyelinase deficiency (ASMD) who are exposed to long term     treatment with olipudase alfa.      The secondary objectives of this study are to obtain data regarding the efficacy of olipudase     alfa and to characterize olipudase alfa pharmacodynamics (PD) and pharmacokinetics (PK)     following long-term administration.   "
97933|NCT02004314|"     This study will evaluate the effect of chloroquine in individuals infected with HIV.     Researchers will aim to determine if chloroquine treatment in participants whose viral loads     are suppressed on combination antiretroviral therapy (ART), results in improved immune     activation and CD4 cell recovery.      The study will recruit 20 individuals and will last approximately 44 weeks. Eligible     participants will receive an oral dose of chloroquine (250 mg) once daily from week 8 through     week 32. All participants will be asked to have rectal biopsy samples (week 0 and week 32) to     study T cell immune activation in the mucosa rectal site.   "
97904|NCT02004691|"     Primary Objective:      The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa     (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for     52 weeks in adult patients with acid sphingomyelinase deficiency (ASMD) by assessing changes     in 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the     United States [US] only, in association with patient perception related to spleen volume as     measured by splenomegaly related score (SRS)); and 2) infiltrative lung disease as measured     by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO).      Secondary Objectives:        -  To confirm the safety of olipudase alfa administered intravenously once every 2 weeks          for 52 weeks.        -  To characterize the effect of olipudase alfa on the patient perception related to spleen          volume as measured by the SRS after 52 weeks of study drug administration. (For the US,          the effect of olipudase alfa on the splenomegaly related score is part of the primary          objective).        -  To characterize the effect of olipudase alfa after 52 weeks of study drug administration          on the following endpoints assessed sequentially:        -  The effect of olipudase alfa on liver volume;        -  The effect of olipudase alfa on platelet count;        -  The effect of olipudase alfa on fatigue;        -  The effect of olipudase.alfa on pain;        -  The effect of olipudase alfa on dyspnea.   "
97905|NCT02004678|"     DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus.     This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor     unblinded), placebo‑controlled, randomized, 2‑part, sequential, single ascending dose, single     center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of     single oral dose of DS‑1150b in healthy subjects and subjects with Type 2 Diabetes Mellitus.   "
97906|NCT02004665|"     to evaluate the incidence of delirium in patients with acute coronary syndrome and its     correlation with adverse events   "
97907|NCT02004652|"     The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of     gastrointestinal function in patient undergoing major gastrointestinal surgery. The     investigators hypothesize that patients who take prucalopride after major gastrointestinal     surgery will have shorter duration of postoperative ileus.   "
97908|NCT02004639|"     Trismus Prevention, Diagnosis and Management: Radiotherapy Planning, Early detection, and     Physical Therapy Intervention   "
97909|NCT02004626|"     This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind,     Multicenter, National, Non-inferiority.      Its purpose is to determine the noninferiority in efficacy of an investigational product in     relation to the product available in the market intended of treating pressure ulcers.   "
97910|NCT02004613|"     Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery   "
97919|NCT02004496|"     Health care has an increasingly demand for mobile applications (App), but studies are rare,     which explore the added value and benefits for patient and physician. Patients in different     disease groups or physicians from different specialties are likely to have different demands.     Research should focus on selected groups to better understand their individual demands. Our     study intends to identify the added value of mobile symptom tracking in a selected subgroup     of patients. We designed an App for breast cancer patients, who receive ambulant chemotherapy     in a breast center. The patients track regularly their well-being and adverse events (AE)     with the smartphone- or web-app and share it with the physician in the medical consultation.     The data entry was designed to meet patient needs based on previous usability testing.      The reporting of AE and well-being are standardized according to the definitions by CTCAE 4.0     and ECOG-Index to ensure the reliability of patient self-reporting.      The primary outcomes are the number of reported AE, the influence on their subjective     well-being and the acceptance of context specific information. We will include 150     participants in this study. The calculated power is 91% respectively 80% for a 10 %     improvement of well-being and a 2.2 increase of detected AEs.      The results will be compared to patients without App and to patients with App but without     shared information.        -  Trial with medical device   "
97911|NCT02004600|"     The hereditary dystrophic epidermolysis bullosa are genodermatosis responsible of a poor     adhesion of the epidermis to the dermis pulling a large mucocutaneous fragility and recurrent     spontaneous or posttraumatic bullous detachment. They are caused by mutations in the COL7A1     gene encoding for the collagen VII.      No curative treatment is avaible. The main cause of patients death is the development of     squamous cell carcinoma, sometimes multiple and paticularly aggressive in repeated healing     part. The photodynamic therapy (PDT) is one of technical reference of multiple actinic     keratoses lesions for adults, which are also pre-epithelioma lesions. The PDT is well     tolerated even by the elderly and requires only a single session.      The main objective of this study is to determine the efficiency of the photodynamic therapy     in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis     bullosa (DEB). The secondary objectives are to evaluate the tolerance of this treatment in     terms of pain and healing, and to evaluate the contribution of confocal microscopy in the     diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis     bullosa. The main evaluation criterion is the cutaneous biopsy before and after (M2) a PDT     session of an epidermal dysplasia area. The secondary criteria are the evaluation of the pain     during the PDT session and the healing of the cutaneous lesion at M0, M2 and M4 (lesion area     and healing time) and correlation histology / MC. Each patient with a suspicious lesion will     be biopsied. In case of agreement for this protocol, there will be 1 PDT session followed by     a consultation of control at 2 and 4 months after the end of treatment.   "
97912|NCT02004587|"     The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an     additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy     White subjects will be investigated.   "
97934|NCT02004301|"     This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male     volunteers. This study is designed to correlate the gastrointestinal transit behaviour of     delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption     profiles.      We will be looking at:        1. The behaviour of the tablets (when, where and how quickly they break up)        2. The gastric emptying time of the tablets (when they leave the stomach)        3. The gastrointestinal transit of the tablets (how long they take to travel through the          gut)        4. Blood levels of the drug (diclofenac)   "
97913|NCT02004574|"     The combination of calcipotriol and betamethasone dipropionate used in an ointment     formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the     short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation     (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and     marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp     psoriasis vulgaris.      Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by     normalizing the reproduction cycle of skin cells. It also relieves itching associated with     psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp     psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012.      Since patient compliance is one of the important factors in achieving effective outcomes in     the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance     compliance and treatment outcomes as well as to provide a safe and effective therapeutic     option.   "
97914|NCT02004561|"     Determine the short and long term safety and efficacy of the Gastric bypass , laparoscopic     sleeve gastrectomy, and Gastric banding (LAGB) on severely obese adolescents. The procedure     selection is made by the patient or patient and guardian. This is not a randomized trial.   "
97915|NCT02004548|"     Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of     daily oral administration of metatinib tromethamine in subjects with solid tumors;     Investigate the influence of food on pharmacokinetic parameters.      Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral     administration of metatinib tromethamine in subjects with solid tumors; To observe     preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive     biomarkers at MTD.   "
97916|NCT02004535|"     The objective of this study is to investigate benefits of binaural hearing for     non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric     candidates are patients with severe to profound hearing loss in one ear and better hearing in     the other ear. (One ear is deaf and the other ear has better hearing and in most cases uses a     hearing aid.) The investigators hypothesize that cochlear implantation of the poorer ear     provides a functional increase in word and sentence understanding in quiet or noise,     perceived benefit, localization ability, and other measures of auditory performance relative     to use of the better hearing ear alone.   "
97917|NCT02004522|"     A Phase 3 clinical trial to examine the efficacy of IPI-145 monotherapy versus ofatumumab     monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or     Small Lymphocytic Lymphoma (SLL).   "
97918|NCT02004509|"     Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and     systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these     patients. The detection of asymptomatic AF episodes is a challenge and the real rate of     occurrence of these episodes remains unknown. The rate of stroke is high among patients who     have received a pacemaker and this device can detect subclinical episodes of rapid atrial     rate, which correlate with electrocardiographically documented AF. The net benefit of     anticoagulant treatment is well established in patients with clinical AF but data about     anticoagulation in subclinical AF setting is unknown. The aim of this study is to assess the     impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable electronic     device (CIED) intensive monitoring, on the incidence of stroke and systemic embolism and     correlate the AF episodes detected by CIED with thromboembolic events. Methods: This is a     prospective, randomized, unicentric, parallel clinical study in patients with     atrioventricular pacemaker, defibrillator or cardiac resynchronization therapy devices in     sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial     fibrillation, range from 0 to 6) ≥ 2 . Patients will be randomized to the intervention group     - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a     1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a     period of 36 months. Group I patients will be submitted to device data collection every 2     months, while the Group II patients will be managed conventionally. Patients from Group I     with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with     clinical AF of both arms. Device data from Group II patients will not be analyzed until they     achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary     endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial     infarction, cardiovascular hospitalization and bleeding rates. Expected outcome: It is     expected that anticoagulation therapy of subclinical AF directed by CIED intensive monitoring     will reduce the incidence of stroke and systemic embolism comparing to patients with     non-diagnosed subclinical AF.   "
97920|NCT02004483|"     Investigators will analyzed systolic and diastolic function during and after ischemia induced     by percutaneous coronary intervention.Also will be analyzed a local work index during acute     ischemia induced by percutaneous coronary intervention.   "
97921|NCT02004470|"     The use of laparoscopy in gynecologic surgery has been well established to decrease     morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional     open abdominal surgery. However, the laparoscopic technique is associated with post-operative     shoulder pain.      We hypothesize that a combination of intraperitoneal saline lavage and active suction removal     of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of     post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.   "
97922|NCT02004457|"     Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public     health concern because reduced commitment to care puts PLWHA at risk for illness progression,     death, and transmission of HIV to others. This project will develop a novel treatment, brief     acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV status as a     pathway to reducing engagement barriers. The clinical and public health impact of this     project will be the development of a simple, low-cost, disseminable intervention that     enhances longitudinal commitment to care so PLWHA can obtain effective medical treatments     that will prolong survival and improve quality of life. We hypothesize that individuals     randomized to brief ABBT will showed increased longitudinal attendance of primary care     appointments.   "
97929|NCT02004366|"     A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure     will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication     or low dose insulin prior to their admission.      This study is a prospective, randomized, open label trial to compare the safety and efficacy     of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin     regimen of glargine once daily plus rapid-acting insulin before meals. Both of these     treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart,     lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.      The patients will be monitored for their blood sugars while the hospital.      If patients are agreeable to participate in the discharge part of the study, the     investigators will randomized them to a treatment group based on their admission HbA1c. The     investigators will follow these patients for 3 months with phone calls and clinic visits, and     will monitor their blood sugars. This is to compare the efficacy of linagliptin and our     discharge treatment algorithm in controlling blood sugars as out patients.   "
97923|NCT02004444|"     JC virus is a benign virus which infects approximately up to 90% of the normal adult     population. However, it may be reactivated in people who have a decreased immune function as     in HIV infection, cancer, chemotherapy, transplant recipients, or in MS patients treated with     natalizumab (Tysabri). In these patients, JC virus can cause a severe brain disease called     Progressive Multifocal Leukoencephalopathy (PML), for which there is no cure.      As of September 2013, 400 MS patients in the world, who have been treated with natalizumab,     have developed PML. The risk of PML is approximately 5 patients in 1000 after 24 months on     the drug. Researchers do not know exactly in which cells of the body the virus lives but it     has been isolated from the blood, urine, cerebrospinal fluid (CSF), and from the brains of     patients with immunosuppression.      In this study, the investigators wish to determine precisely where the virus lives, and how     the body prevents it from causing brain disease.      Because of the association of PML with natalizumab, the investigators would like to see if     there is a difference in the amounts of virus in blood, urine, and CSF found in MS patients     treated with natalizumab or those treated with different medications for MS, or those not     treated at all. The investigators hope that this knowledge will allow us to find better ways     of preventing the development of PML as well as treatments for patients with PML.   "
97924|NCT02004431|"     The experience of pain is common among hospital inpatients. Orthopaedic surgery often results     in significant pain, which may last for some time. About one in eight people will experience     long-term or chronic pain after surgery, which can impact on quality of life and mood. Some     risk factors are known for chronic post surgical pain (CPSP) and these include patient     factors, surgical factors and anaesthetic factors. We know that mood problems (anxiety and     depression) increase the risk of CPSP. What is not known is how short term changes in mood     are related to the experience of pain after surgery and how this impacts on CPSP. This study     is designed to investigate the relationship between both short and long-term mood problems     and short and long-term pain and quality of life after orthopaedic surgery. The study will     provide valuable information to allow us to design a psychological intervention, which might     reduce the risk of short-term post surgical pain and CPSP.      This study also aims to measure a number of other variables, which may be related to CPSP     including medication use, other medically unexplained symptoms and catastrophic thinking in     response to pain.      All patients having planned orthopaedic surgery will be asked to enter the trial. Those     consenting to involvement will complete a questionnaire assessing the variables described     above. They will be divided into two groups depending on whether they have significant pain     on the day after their surgery. As the primary aim of the study, the rates of significant     anxiety or depression will then be compared between these two groups.      Secondary outcomes will be assessed by a questionnaire sent to the patients at 6 months after     their surgery. Descriptive statistics will be produced for all the variables and use to model     a future study, which would assess the effect of a psychological intervention on acute and     chronic post surgical pain.      Our hypothesis is that patients are more likely to experience acute anxiety and depression or     display catastrophic thinking if they suffer significant post-surgical pain. The study is     powered to reliably detect a three-fold difference in the prevalence of psychopathology     between patients with and without acute pain on day 1 after elective orthopaedic surgery.   "
97925|NCT02004418|"     Patients with localized prostate cancer are routinely treated with radiation therapy to the     entire prostate gland. The investigators can identify where the cancer is concentrated in the     prostate gland using a newer specialized imaging technique called 11C Choline PET (stands for     choline positron emission tomography). This is different from the older type of PET scan that     has been used in the past (called FDG PET) which has not been as accurate as the new PET scan     for identifying where the cancer is in the prostate gland. It has also been shown that     delivering higher doses of radiation to prostate cancer cells in the prostate have resulted     in better cure rates in patients with prostate cancer. Therefore for goal number one the     investigators want to give higher radiation dose to the prostate cancer cells. But the     challenge has been that delivering higher doses of radiation to the prostate gland may also     increase the chance of complications from the higher doses of radiation to the rectum,     bladder and surrounding area. Therefore for goal number two the investigators want to     minimize radiation dose to the rectum, bladder and surrounding area. 3-Tesla Magnetic     Resonance Imaging (3T MRI) is a new kink of scan that will be used in this study to identify     the urethra in the prostate so that the investigators can minimize the radiation dose to the     urethra. The investigators believe the 3T MRI scan is able to point to the areas of cancer     that may be able to predict how well the treatments may work, as well as which areas of the     tumor appear to be responding to failing.      In this study, the investigators will keep the dose of radiation to the rectum and bladder as     low as possible while increasing radiation dose to parts of the prostate with more cancer     cells. The investigators will compare the cure rates in this study with the cure rates of     other patients receiving the standard treatment in which the same dose of radiation is     delivered throughout the prostate gland. The investigators will also compare the rates of     complications in this study with the rates of complications in patients receiving the     standard treatment in which the same dose of radiation is delivered throughout the prostate     gland.   "
97926|NCT02004405|"     Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many     symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits     potentially mediated through changes in autonomic modulation. Strengthening is one of the     less studied exercises in FM, and the acute and chronic effects of strengthening on the     autonomic system remain unknown. The objective of this study is to assess the effects of     strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of     life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly     selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity     of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different     exercises. The primary outcomes will be pain measured using the Visual Analog Scale (VAS) and     the Heart Rate Variability (HRV) analysis. Other outcomes will be assess: fitness measured by     treadmill test, the sit and reach test (Wells and Dillon's Bench), handgrip dynamometry; and     quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate     Trait-State Inventory (IDATE), a short-form health survey (SF-36). Statistical analyses and     ethical procedures: The visual analog scale (VAS) for pain will be the primary measure used     to determine sample size. Statistical significance will be set at 5% and power of 80%. These     led to at least 58 participants to be randomized. The main hypothesis is that strengthening     exercise is a better treatment than flexibility exercise to improve pain, HRV and quality of     life. In all measures tested we will consider the null hypothesis (H0) as being the point of     equality between groups tested and H1 the point of difference. Bilateral tests were carried     out adopting a 5% level of significance. The normality of the results will be tested using     the Shapiro-Wilk test. Student's t-test for paired samples will be used to perform     intra-group comparisons at different times, when the data were normally distributed, and the     nonparametric equivalent of Student's t-test (Wilcoxon test) will be used when the data show     an asymmetrical distribution. To compare the data between the STRE and FLEX groups, ANOVA for     repeated measures will be used, followed by post-hoc Bonferroni's test.   "
97927|NCT02004392|"     This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled     studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study     EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive     EVP-6124 for an additional 26 weeks.   "
97928|NCT02004379|"     Know through routine clinical practice the effectiveness and safety of current treatment of     hepatitis C virus, genotype 1, for patients who have never been treated and for patients who     have been previously treated   "
97956|NCT02004002|"     The purpose of this proposal is to determine whether dietary protein restriction has     beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men     and women.   "
97930|NCT02004353|"     The purpose of this study is to collect patient related benefit data following treatment for     permanent hearing loss with a hearing implant from the company Cochlear over a period of 2     years post treatment.      Assessment of benefits is based on standard questionnaires of hearing ability and quality of     life in general.   "
97931|NCT02004340|"     The purpose of this study is to determine whether transcutaneous auricular vagus nerve     stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.   "
97935|NCT02004288|"     The aim of this study is to investigate whether Lactobacillus reuteri could have a beneficial     role in treatment of children and adolescents with Anorexia nervosa who develop motility     disorder due to the malnutrition regarding the normalization of the motility, as well as the     possible role of probiotics on nutritional recovery, especially on bone health.   "
97936|NCT02004275|"     This randomized phase I/II trial studies the side effects and best dose of pomalidomide and     ixazomib when given together with dexamethasone and to see how well pomalidomide and     dexamethasone with or without ixazomib works in treating patients with refractory multiple     myeloma. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the     immune system in different ways and stop tumor cells from growing. Ixazomib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet     known whether pomalidomide and dexamethasone are more effective with or without ixazomib in     treating multiple myeloma.   "
97937|NCT02004262|"     Test the safety, immune response and efficacy of GVAX pancreas vaccine (with     cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with     previously treated metastatic pancreatic adenocarcinoma   "
97938|NCT02004236|"     Interventional, prospective, randomized, double-blind, placebo-controlled and parallel     assignment study, in which patients with Autism Spectrum Disorder (ASD) are two types of     intervention by transcranial random noise stimulation (tRNS), to improve verbal fluency and     empathy.   "
97939|NCT02004223|"     Current standard treatment for prostate cancer involves giving patients approximately 40     doses of radiotherapy, one dose per day over an 8 week period. The purpose of this study is     to assess the effects of giving two separate high doses of a special type of precision     radiotherapy to the prostate and then 5 weeks (instead of 8 weeks) of standard radiotherapy.      Hypothesis: It is safe to give patients an extra two doses of high-precision radiotherapy     prior to commencing a shorter period of standard radiotherapy for prostate cancer.   "
97940|NCT02004210|"     The aim of this study is to compare the efficacy of conventional transarterial     chemoembolization(TACE) and transarterial radioembolization in patients with unilobar     advanced hepatocellular carcinoma.   "
97941|NCT02004197|"     Helicobacter pylori is strongly associated to the development of gastrointestinal disorders.     Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted     in significant eradication failure. Clinical trial was conducted to see the efficacy of     current quadruple and phytomedicine-based therapies for the eradication of H. pylori     infection and relief in its associated symptoms in Pakistan.   "
97957|NCT02003989|"     HIV patients may suffer sooner from aging than average population, including brain aging. Our     hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in HIV     patients, this loss could be detected earlier by a thinning down of retinal nerve fiber layer     (RNFL), compared to non HIV patients of the same age.   "
97958|NCT02003976|"     The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving     optimized non-surgical treatment plus surgical realignment of the tibia, or optimized     non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months     follow-up will suggest favourable changes in patients undergoing surgical realignment when     compared to patients receiving non-surgical treatment only.   "
97942|NCT02004184|"     Non-small-cell lung cancer (NSCLC) accounts for a majority (approximately 85%) of lung cancer     cases. Patients with localized disease can be cured through surgery, but only 20 % are     operable.For the majority of patients with advanced disease, palliative cytotoxic     chemotherapy remains the recommended therapy. Chemotherapy prolongs survival and improves     quality of life.      The recommended first-line therapy is 4-6 courses of a platinum in combination with a third     generation compound (e.g. gemcitabine, vinorelbine, docetaxel, pemetrexed, paclitaxel). After     first-line therapy, it has been recommended to observe the patients and offer second-line     chemotherapy at disease progression.      Regimens for second-line therapy include docetaxel or pemetrexed monotherapy. Pemetrexed is     less toxic and superior to gemcitabine in non-squamous NSCLC, whereas docetaxel is the     recommended second-line therapy in squamous cell carcinoma.      The results of the studies of maintenance pemetrexed therapy are encouraging; the observed     survival benefit is clinically relevant and relatively large considering the poor survival in     patients with advanced NSCLC. Furthermore, pemetrexed appears to be well tolerated. There     are, however, several limitations to the studies that have been conducted: Relatively few     elderly patients and no PS 2 patients were enrolled - and not all patients on the     control-arms received pemetrexed at progression.      The overall aim of this study is to investigate whether immediate maintenance pemetrexed     therapy prolongs survival compared to observation and pemetrexed therapy at progression in     patients with advanced NSCLC. Furthermore, it will be explored whether patients with     'performance status' 2 and elderly ≥ 70 years tolerate and benefit from maintenance therapy;     and what characteristics and blood biomarkers are associated with sensitivity and     tolerability of such therapy.   "
97943|NCT02004171|"     Electronic cigarettes have shown promise but have yet to proven effective for smoking     cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who     are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The     investigators hypothesize that electronic cigarettes will be comparable to the nicotine     inhaler in terms of smoking cessation.   "
97944|NCT02004158|"     In this proof-of-concept study, the investigators will assess the ease and usefulness of a     positive psychology program in patients with acute coronary syndrome and less-than-optimal     adherence to health behaviors. The investigators believe that positive psychology (a field     that studies boosting positive emotions rather than simply reducing negative emotions) will     help this cardiac population to be more healthy. The investigators want to determine whether     this positive psychology program has the potential to be an adjunctive treatment for cardiac     populations.   "
97945|NCT02004145|"     In this study, the investigators will perform an exploratory randomized trial of Positive     Psychology (PP). The trial will consist of 50 participants and will compare the impact of a     phone-based PP intervention vs. an attentional control condition, in Major Depressive     Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a     12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12     weeks.      Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP     intervention in this high-risk population.      Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP     and with follow-up data from at least 80% of subjects). The ratings of ease and subjective     helpfulness of the exercise and other mental states as measured before and after each PP     exercise will be more than 6 out of 10 and higher than the same ratings obtained from     subjects in the control condition.      Specific Aim #2: To examine the impact of the six-session PP intervention on positive     psychological well-being.      Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores     on scales of optimism (measured via the Life Orientation Test-Revised [LOT-R]), gratitude     (Gratitude Questionnaire-6 [GQ-6]), and positive affect (Positive Affect Negative Affect     Schedule [PANAS]) at 6 and 12 weeks.      Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide     risk factors.      Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness     Scale [BHS]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk     Tracking scale [CHRT]), and depression (Quick Inventory of Depressive Symptomatology—Self     Report [QIDS-SR]) at 6 and 12 weeks.      We will also measure impact on readmission and suicide attempts to assess these key outcomes.   "
97946|NCT02004132|"     The study involves application of Axiron to each underarm. The study will evaluate the     transfer of testosterone from underarms to the clothing items that the participant is wearing     and other fabric items washed with participant's' clothes. The study is approximately 6 days,     not including screening. Screening is required within 28 days prior to the start of the     study.   "
97948|NCT02004106|"     This open-label, multi-center, dose-escalation study will evaluate the safety,     pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic     Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The     study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single     participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]).     Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every     2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw,     q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will     only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the     investigators, is in favor of the participants. Participants will be treated until disease     progression, unacceptable toxicity or withdrawal from treatment for other reasons or death     for a maximum duration of 24 months.   "
97949|NCT02004093|"     This study will evaluate the efficacy and safety of pertuzumab in combination with     carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian     cancer. The anticipated time on study treatment is 3-12 months.   "
97950|NCT02004080|"     CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI)     care in the ICU setting   "
97951|NCT02004067|"     In the present study the investigators aim to determine the efficacy of an immunomodulating     topical medication, compared with a topical lubricant, on the treatment of dry eye disease     (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative     DED.   "
97952|NCT02004054|"     The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable     symptom to evaluate in pathologies affecting the optic nerve   "
97953|NCT02004041|"     The purpose of this study is to test whether VLY-686 can reduce chronic pruritus in subjects     with treatment-resistant pruritus associated with atopic dermatitis in comparison with     placebo.   "
97954|NCT02004028|"     This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery)     study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects     will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days. Pre- and     post-treatment biopsies and blood samples will be collected. The purpose of this study is to     assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor     response rate to VS-6063 (defactinib) will be also be assessed.   "
97955|NCT02004015|"     Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis     (abdominal echography) in the first minutes of after general anesthesia induction.      Primary End Point: proportion of patients with a score of motion = 0   "
97960|NCT02003950|"     Craving differs from hunger because it occurs even when a person is in a satiated state and     in the absence of an energy deficit. Craving is usually triggered by specific foods and may     be attributable to certain sensory properties of foods. Foods that are craved are often     regarded as less healthy choices, and are higher in energy content. Chocolate is one of the     most commonly reported foods craved by people in this country. Together, craving for     chocolate has been suggested to be a possible cause of weight gain and access to chocolate     therefore needs to be restricted.      However, it remains unknown if restriction may induce maladaptive eating behaviors of     chocolate cravers. The anticipation of going on a diet has been shown to cause restrained and     disinhibited eaters to react by consuming more chocolate. In this study, we will examine if     this response is also found in chocolate cravers when they are asked to undergo three weeks     of chocolate restriction. This study will also examine chocolate cravers' response after the     chocolate restriction is lifted. We hypothesize that chocolate consumption of cravers will     increase both before and after chocolate restriction is imposed. We also hypothesize that     chocolate craving is specific to the food rather than its sweet taste, and that chocolate     cravers are less willing to substitute chocolate for salty snacks, natural snacks, and sweet     non-chocolate snacks during the restriction.   "
97961|NCT02003937|"     Spinal muscular atrophy type III, (SMAIII) is a disease in the nerve cells in the spinal cord     which leads to to progressive muscle weakness and atrophy. No effective treatment is     available for SMA. We have previously shown that patients with muscular dystrophies improve     oxidative capacity (VO2max), muscle strength and daily function by aerobic conditioning.     Patients with SMAIII share many clinical features with these conditions, although the     mechanism of muscle weakness is different. In this study, we investigated how patients with     SMAIII respond to aerobic training.      6 patients and 9 healthy age- and sex-matched controls completed a 12 weeks training program.     Subjects performed a total of 42 training session of 30 min on a stationary cycle ergometer     at home. The work intensity was moderate and set to match a target heart rate.      Training induced an increase without inducing muscle damage. However, training-induced     fatigue was a major complaint in all patients, and caused one patient to drop out, increased     the need for sleep in three patients and two had to modify the training program.      The fatigue limits the use of this therapy. The training-induced fatigue, which is not     encountered in muscle diseases, warrants investigations into alternative training methods to     improve quality of life in patients with SMAIII.   "
97962|NCT02003924|"     The purpose of this study is to assess the safety and efficacy of enzalutamide in patients     with non metastatic prostate cancer.   "
97963|NCT02003911|"     Asthma is a chronic lung condition in children, and often requires hospitalization for acute     exacerbations. Azithromycin has been used successfully in other chronic lung diseases,     including cystic fibrosis. Despite limited clinical evidence, some pediatricians use     azithromycin in children hospitalized with asthma, citing either treatment of atypical     pathogens or its proposed anti-inflammatory properties. We propose a clinical trial to     determine if azithromycin will shorten length of stay in children hospitalized with acute     asthma exacerabations.   "
97964|NCT02003898|"     The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic     MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.   "
97965|NCT02003885|"     The purpose of this study is to determine desflurane's dose-dependent effect on left     ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of     lateral mitral valve annular velocity at three different desflurane concentrations would be     analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery     patients   "
97966|NCT02003872|"     This is an open-label trial investigating the effect of Spatz 3 intragastric balloon on     weight loss on obesity and associated co- morbidities.      The study aim is to evaluate the effect of the intra gastric balloon on weight reduction and     on related co- morbidities during 1 year of balloon implantation and a year following     explantation.   "
97967|NCT02003859|"     Studies over the past two decades have convincingly demonstrated the role of barrier     dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that     optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess     mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be     predictive of disease relapse in adult IBD patients. The purpose of the current study is to     determine the predictive value of pCLE findings in pediatric IBD patients.   "
97968|NCT02003846|"     There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal     intensive care units (NICU) use an underwater bubbling system and others use a ventilator to     generate the pressure. There is no right or wrong way to generate the pressure and both     methods are approved and accepted.      The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each     for a defined time period and reviewing the infant's vital signs. The investigators expect     that the pressure generated by bubble CPAP will be better and lead to improved vital signs.   "
97969|NCT02003833|"     Anecdotal evidence suggests that patients' skin quality may improve as a result of     poly-L-lactic acid injection. While this is not the primary goal of such treatments it is     often seen and described as so called Sculptra glow.      The aim of this study is to evaluate the effect of repeated subcutaneous injections of     poly-L-lactic acid (Sculptra Aesthetic) on skin quality.      Participating subjects will be part of the study for about 15 months. There will be an     initial treatment period of up to 12 weeks, followed by a 12-month follow-up period. There     will be a total of 7 scheduled visits.      This study is a double-blind, randomized study. Double-blind means that neither the     subjects nor the study doctor will know who is receiving Sculptra Aesthetic or placebo.     Randomized means that the group subjects will be placed in is decided by chance, similar to     drawing numbers out of a hat or flipping a coin. Subjects will have a 1 out of 2 chance of     receiving the active study drug. After the completion of the study, if subjects are assigned     to the control (placebo) group they will receive free injections with Sculptra Aesthetic same     as the treatment group.   "
97998|NCT02003456|"     Positron emission tomography (PET) scans can be used to evaluate whether parts of the heart     muscle are alive but receiving inadequate blood supply. This study involves the use of two     radiotracers that will measure whether heart muscle cell are alive and quantify the blood     supply to the heart muscle.   "
97970|NCT02003820|"     We hypothesize that oral hygiene habits in children 8-12 years of age can be improved using     video format Social Story intervention techniques. The purpose of this study is to     investigate the effectiveness of video format social stories used to inform and educate     children and parents about proper dental hygiene technique over a 6 week intervention period.     We will measure the success of intervention using data collected from clinical exams and     caregiver/participant surveys. Evaluation of data collected will be used to determine the     effectiveness of the intervention.   "
97971|NCT02003807|"     The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of     gastrointestinal tract. Therefore there is growing evidence that IBS could occur after     gastroenteritis. However, little is known about the incidence of IBS after acute     diverticulitis. We thought that post diverticulitis status could induce IBS because     diverticulitis was also bowel inflammatory disorder. This survey was designed to identify     incidence of post-diverticulitis IBS and risk factor in Korea.   "
97972|NCT02003794|"     To study the result of intravenous fluid in patients with acute ischemic stroke within 72     hours.   "
97973|NCT02003781|"     Set the prospective cohort (CMERC-HI) to study the known and novel etiologies and related     factors for predicting clinical outcomes in Korean patients with high risk cardiovascular     disease.   "
97974|NCT02003768|"     The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of     intracranial pressure (ICP). Previous studies have proposed that ultrasonographic     measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP.     The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure     and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol     based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).   "
97975|NCT02003755|"     Cerebral palsy (CP) is a group of disorders of the development of movement and posture but     often changing motor impairment syndromes. The spastic subtypes are the most common     manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease     of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of     presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with     CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated     range of motion could reduce muscle's activation effectively. The polyarticular movement     training might increase joint range of motion and reduce the muscle activation. But the     polyarticular movement training is difficulty for some individuals with CP. The single joint     movement training may achieve the same effect as the polyarticular movement training. The     purpose of this study was to investigate the effects of continuation passive range of motion     (CPM) training whether could get the improvement of soleus hypertonia in individuals with CP.   "
97976|NCT02003742|"     The purpose of the this international, multicenter, randomised, single-blind, parallel group,     Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided     intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower     Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients     not adequately controlled by medical therapy with α-blockers, as assessed by a change from     baseline in the International Prostate Symptom Score (IPSS) total score.   "
97977|NCT02003729|"     The SIESTA Home Sleep Study is a pragmatic, multi-centre randomized single-blinded two arm     trial, assisted by a Decision Analytic Model, primarily designed to assess the accuracy,     effectiveness and cost-effectiveness of diagnosing OSA assisted by ApneaDx™ as compared to     PSG as a reference standard.   "
97979|NCT02003703|"     Hepatitis B virus infection is a common occurrence among patients with HIV. Effective     vaccines are available, but there's some uncertainty regarding specific dosages, specially     among those who have not responded to an initial vaccination. The purpose of this study is to     determine the effectiveness of a simplified immunization schedule compared to a high-dose     one.   "
97980|NCT02003690|"     Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed     suicide in adolescence, and is further associated with poor psychosocial functioning,     substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for     other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of     pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet,     little is known about effective psychotherapy approaches for this population, and none     expressly target suicidality. An efficacious, cost-effective psychosocial intervention for     adolescents with bipolar disorder has great potential to decrease the substantial morbidity,     mortality and costs associated with adolescent bipolar disorder.   "
97981|NCT02003677|"     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the     investigated drug on the body)properties of FIAsp (faster-acting insulin aspart) in geriatric     and younger adult subjects with type 1 diabetes.   "
97982|NCT02003664|"     This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the     efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence.     The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of     cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine     brain mechanisms of relapse/recovery, participants will complete fMRI sessions before,     during, and after treatment. Brain responses to specific probes of reward and inhibition will     be used as biomarkers predicting drug use during and after the treatment.   "
97983|NCT02003651|"     The primary objective of this study is to evaluate the effectiveness of ingesting an     alkylamide-rich echinacea root product (Quick Defense, Gaia Herbs) for 2 days immediately     following each onset of acute respiratory illness (ARI) symptomatology during a 12-week     period in the winter and early spring in women.      Hypothesis: Subjects randomized to Quick Defense compared to placebo over a 12-week period     will experience reduced ARI symptomatology, both acutely during each ARI episode and     collectively over the entire 12-week study period.   "
97985|NCT02003625|"     This research study is evaluating a drug called meloxicam to see if it provides a benefit to     people receiving Autologous Hematopoietic Stem Cell Transplantation (AHSCT).      The participant is currently scheduled to receive an AHSCT, which is a procedure that removes     blood-forming stem cells (cells from which all blood cells develop) from the body. These stem     cells are stored and later given back to the participant by a process called apheresis. This     is a standard procedure to treat certain blood diseases such as lymphoma and multiple     myeloma. However the use of meloxicam with this procedure is considered investigational.      Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) which is given to decrease fever,     swelling and pain that may come with inflammation. It has been approved by the FDA for the     treatment of arthritis however it has not been approved for use in people receiving AHSCT.      This study will compare the combination of meloxicam with a drug called G-CSF (also called     neupogen), to the combination of G-CSF with an agent that has no medicine (placebo). G-CSF is     a substance that causes blood stem cells to change or increase in number when given to people     undergoing AHSCT. The researchers would like to learn if giving meloxicam in combination with     G-CSF to people before they undergo AHSCT will increase the number of stem cells available in     the blood to collect and make the collection process easier.   "
97986|NCT02003612|"     A retrospective analysis of historical data looking at hematological remission and survival     in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.   "
97987|NCT02003599|"     Breast neoplasm is the second most common type in the world. Radiation therapy is a key     component in the treatment of breast cancer. Acute skin reaction is one of the most common     side effects of radiation therapy. Several studies were performed for prophylaxis of this     adverse event, however, until this moment there is no consensus for clinical practice .     Second meta-analysis , the ideal candidate for the radiodermatitis prevention would be an     agent capable of repairing damage to DNA or agents that promote cell proliferation . The low     power laser promotes tissue repair ( reduces inflammatory phase and induces collagen     synthesis ) . Its use in the treatment of adverse events of cancer treatment is well     established in two situations : in the prophylaxis and treatment of mucositis and in the     treatment of lymphedema . The purpose of this study is to use the low power laser in patients     with breast cancer undergoing radiotherapy treatment to evaluate the effects of Laser InGaAIP     660Nm in preventing radiodermatitis.   "
97988|NCT02003586|"     The study is designed to determine the extent to which foods containing a plant-based     ingredient affect blood glucose and hormonal response in healthy subjects.   "
97989|NCT02003573|"     Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety     and pharmacokinetics of different volasertib administration schedules in combination with     decitabine in previously untreated AML patients >= 65 years of age who are considered     ineligible for standard intensive therapy, or patients with relapsed or refractory AML     regardless of prior treatment status.      MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of     volasertib in combination with decitabine in previously untreated patients with AML >= 65     years of age and considered ineligible for standard intensive therapy.   "
97990|NCT02003560|"     The purpose of this study is to determine in a phase II clinical trial whether accelerated     partial breast irradiation after breast conserving surgery using 3 dimensional external beam     radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive     breast cancer patients is safe without causing serious late radiation side-effects.   "
97991|NCT02003547|"     A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3     Ophthalmic Formulations of AMA0076 in Healthy Subjects   "
97992|NCT02003534|"     This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle     glaucoma and ocular hypertension.   "
97993|NCT02003521|"     We hypothesized that the ability of the Lung Flute to enhance mucus clearance from the lower     airways could be used to improve asthma control, if the device is used on a chronic basis.     The primary end point of the study is the comparison of Asthma Control Test (ACT) - a     validated questionnaire for asthma control and exhaled NO before, during and after using the     lung flute. Several secondary end points were assessed for efficacy and safety, including     health status, spirometric lung function, stepping down controller therapy and daily     albuterol use.   "
97994|NCT02003508|"     This study will examine how common HPV infection is in teenage males in Australia before and     after the introduction of universal school based vaccination of males in Australia.   "
97995|NCT02003495|"     The purpose of this observer-blind study is to evaluate the safety, reactogenicity and     immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6     years-old children.   "
97996|NCT02003482|"     Anatomical changes that take place during Intensity modulated radiation therapy (IMRT)     treatments for cancers of the head and neck cause significant dosimetric changes.   "
97997|NCT02003469|"     Background and Rationale Cardiovascular disease is highly prevalent in the kidney transplant     population, accounting for approximately 40% of all deaths and significant morbidity. The     morbidity and mortality experienced by kidney transplant recipient's results from an excess     of pre-transplant risk factors that are exacerbated by kidney transplantation along with the     development of novel risk factors. Hypertension (HTN) is the most consistent cardiovascuar     disease risk factor in transplant recipients..      A large number of studies have been done in the general population comparing ambulatory blood     pressure monitoring (ABPM) to casual, office based and home measures of blood pressure (BP).     The results have clearly demonstrated that ABPM gives a more accurate representation of BP     and arguably should be used as part of routine patient care. ABPM has been shown to reveal     patients both with white-coat and with masked HTN, nocturnal HTN and lack of nocturnal     dipping. Ambulatory BP measures afford us a non-invasive, highly accurate way to evaluate and     treat kidney transplant recipients.      Live kidney donors (LKD) have significantly expanded the supply of critical organs. Of     paramount importance of course has always been donor safety. As a result, candidates are     known to be healthy at the time of donation. Ambulatory blood pressure monitoring allows a     unique opportunity to examine the effects of live kidney donation on the blood pressure     profiles of LKD.      Methods Study Design: Prospective, 5-year, single center study of ABPM, cardiovascular and     graft outcomes in incident and prevalent live kidney donors, kidney and kidney-pancreas     transplant candidates and recipients.   "
97999|NCT02003443|"     The primary objective of this project is to determine whether self-administered acupressure     is an effective and feasible self-management strategy for older adults with symptomatic KOA.     Participants will be randomized to three treatment groups: pain-relief acupressure, sham     acupressure, and usual care (UC). The two acupressure groups will be taught to administer     pain-relief and sham acupressure, respectively, on themselves 5 days/week for 8 weeks. The     usual care group will not be required to change any of their treatment practice. Outcome data     will be collected at baseline, and the 4th and 8th week after baseline.   "
98000|NCT02003430|"     The purpose of this study is to investigate the association between the Independent     Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA)     and poor tolerance to radiation treatment in older and younger patients with non-ovarian     gynecological cancers.   "
98001|NCT02003417|"     This study will evaluate the proportion of prostate cancer patients receiving external beam     radiation therapy (EBRT) and androgen deprivation therapy (ADT) with controlled blood sugars     (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total     cholesterol, LDL, HDL, triglycerides) at baseline, 3 months, and 12 months after completing     radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary     and preventive care as well as patient-reported quality of life and satisfaction with care     among these patients will be evaluated at baseline and 12 months.   "
98002|NCT02003404|"     This purpose of this study is to look at three commercially available ostomy barriers on     peristomal (around the stoma) skin. Repeated barrier application and removal over years     causes changes to the skin that the investigators wish to investigate. The primary objective     is to measure peel force on normal skin and peel force on peristomal skin, with the intent of     determining if differences occur. The study hypotheses is that no differences exist.   "
98003|NCT02003391|"     The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with     travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with     open-angle glaucoma or ocular hypertension.   "
98004|NCT02003378|"     Some patients' heart rates do not increase as needed during activities and exercise, which     can make them feel tired and fatigued easily. The patients in this study have a pacemaker     with a FDA approved rate response sensor, which senses activity level by sensing motion     (through a component known as an accelerometer) and/or breathing changes (known as minute     ventilation). These changes in motion or breathing make the pacemaker increase the patient's     heart rate. This study is being conducted to see which rate response sensor is better (motion     driven or breathing driven). The study is also investigating whether optimizing the sensor     based on the individual patient will give better results in terms of increasing the patient's     exercise capacity. The hypothesis is that rate responsive pacing driven by the minute     ventilation sensor results in improved functional capacity compared to accelerometer in     chronotropically incompetent patients.   "
98005|NCT02003365|"     This study will be an open-label, single administration design, conducted in patients with OA     of the knee.      Patients will be enrolled sequentially with 8 to 10 patients per Cohort as follows:      Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16     Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12     Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12      Each patient will be evaluated for up to 12, 16 or 20 weeks following a single     intra-articular (IA) injection of FX006 at 10 mg or 40 mg or TCA IR 40 mg, depending on the     assigned Cohort. Following the screening visit, safety will be evaluated at three (3)     out-patient visits and synovial fluid will be collected at Day 1 for baseline measurements     and the Final Visit for drug concentration measurements.   "
98006|NCT02003352|"     Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering from     post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators will     study PTSD treatment in military Veterans who have suffered traumatic brain injuries.     Investigators will use 1 independent specialty treatment centers that utilize a specific     novel methodology of PTSD treatments and study the clinical outcomes of veterans who have     suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD.     Investigators hypothesize that the treatment of PTSD will have a significant outcome with     neurological physical and vestibular rehabilitation when compared to psychological or     psychiatric therapy. This study will use gold standard measurement scales and compare changes     in the scales after treatment to evaluate the treatments.   "
98007|NCT02003339|"     For patients who are suffering from hepatocellular carcinoma and are treated with     radioembolization, the purpose of this study is to analyse parameters of functional MRIs that     are modified early and to detect parameters that vary significantly after treatment.   "
98008|NCT02003326|"     The objective is determine the strain measured at the bedside could be a dynamic prognostic     marker of during Acute respiratory Distress Syndrome (ARDS).   "
98009|NCT02003313|"     The purpose of this double-blind study is to evaluate the safety, reactogenicity and     immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30     years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135     Meningococcal Polysaccharide Vaccine.   "
98010|NCT02003300|"     The primary aim is to confirm the efficacy of a new non-invasive method for measuring the     oxygen uptake during general anesthesia of patients undergoing surgery under cardiopulmonary     bypass. The method has already been successfully tested in the laboratory under controlled     conditions. In the patient group chosen, oxygen uptake is simultaneously calculated, for     comparison purposes, from monitoring measurements made routinely as part of normal patient     care in these cases, using a pulmonary artery catheter - an invasive technique from which     severe complications occasionally arise, including death.      A secondary aim is to elucidate the time course of uptake of the anaesthetic vapor,     isoflurane, during this kind of surgery.   "
98011|NCT02003287|"     The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of     Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration     when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in     the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal     penetration and tracheal aspiration in breastfeeding NICU infants.   "
98012|NCT02003274|"     BACKGROUND. Optimal glucose control can prevent/relent tissue damage in patients with type 1     diabetes mellitus (T1DM). Ongoing efforts aim at developing closed loop control (CLC)     algorithms linking subcutaneous continuous glucose monitoring (CGM) and insulin delivery     (CSII). Substantial improvement towards an effective artificial pancreas system is still     needed, especially in the regulation of post-meal glucose. Application of metabolic control     analysis (MCA) can unveil and quantify distortions in the system properties of the     glucose-insulin (pump) system (GIS), by measuring the coefficients of control (CCs) of     glucose. Our approach rely on previous experience with our previous pilot protocol     (NCT01800734).      AIM. We will outline and compare features of GIS in T1DM patients and in healthy controls     during differently sized breakfast meals and during 24-hour periods. The reproducibility of     our approach will also be assessed.      METHODOLOGY. Three protocols will be carried out. All T1DM patients will be on CGM/CSII     therapy. In all three protocols, study 1 will be an euglycemic insulin clamp in T1DM patients     and a frequently sampled intravenous glucose tolerance test (IVGTT) in healthy controls.        -  Protocol 1: 10 T1DM patients on CGM/CSII and 10 control subjects will ingest a mixed          meal of different size (320 and 640 kcal) on two separate occasions.        -  Protocol 2: 5 T1DM patients will ingest two repeat 320 kcal meals, whereas other 5 T1DM          patients will ingest two 640 kcal meals on two separate occasions.        -  Protocol 3: 10 T1DM patients and 10 controls will be monitored for 24 hours, during          which they will ingest 3 mixed meals.      Substrate (including CGM)/hormone responses will be measured in all studies. Comprehensive     single meal and 24-hour models of GIS will be built, MCA will be applied and the CCs of     glucose assessed, thereby allowing to outline and to compare the CCs of glucose between     patients and controls.      EXPECTED RESULTS. Our data will be of use in devising novel clinical strategies in T1DM,     including, but not limited to, development and refinement of CLC algorithms along the path     towards an effective artificial pancreas system.   "
98013|NCT02003261|"     This study is to examine the superiority of the combined treatments of transdiagnostic     cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with     the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms     among depressive and anxiety disorders.   "
98014|NCT02003248|"     The proposed study is to evaluate the safety and initial effectiveness of the ExAblate     Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with dyskinesia of     Parkinson's Disease (PD)        -  Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated          with ExAblate Transcranial MRgFUS treatment of dyskinesia of PD        -  Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial          MRgFUS treatment of dyskinesia of PD.Efficacy will be determined utilizing the UPDRS-IV          for dyskinesia in PD from examinations at baseline and every 3-Months post-ExAblate          treatment.      This study is designed as a prospective, single-site, single arm, nonrandomized study.     Assessments will be made before and three months after MRgFUS for clinical symptom relief,     quality of life (QoL) improvements, and safety of MRgFUS in the treatment of LID. Relative     Safety will be evaluated using a common description of Significant Clinical Complications for     patients treated in this study. This study will be performed on the 3T MR scanners.   "
98015|NCT02003235|"     The study will evaluate the effect of Reviview™, a dichoptic video display device for     administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.      The effect of the treatment will be measured by the change from baseline in Visual acuity and     in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.   "
98018|NCT02003196|"     Morbidity and mortality of ICU patients is increased by the development of a     immunosuppression systemic (IS). This IS develops in the early hours of hospitalization and     is responsible for severe infections, including viral reactivations (Cytomegalovirus or     Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and     mortality in intensive care units. In clinical practice, they are searched at the onset of     organ failure or unexplained fever. The investigators wish to conduct this research in the     stroke patients to assess the predictive power of these viral reactivations on the duration     of mechanical ventilation.   "
98039|NCT02002910|"     To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided     treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide     change and to analyze the cost-effectiveness of its dual diagnosis.      To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score     evaluated physiological assessment of coronary stenosis and its clinical effectiveness.   "
98019|NCT02003183|"     The project is designed to assess early diagnosis of Chronic Traumatic Encephalopathy (CTE),     a neurobehavioral syndrome manifested by failed relationships, marriages, and businesses,     emotional disturbances, depression, alcohol and substance abuse, and suicide attempts and     completions. CTE typically begins after a latency period of several years following single or     repeated Traumatic Brain Injuries (TBIs). A history of cerebral concussion may or may not be     present.      This study builds upon prior work at UCLA using Positron Emission Tomography (PET) to     identify normal and abnormal functional patterns in the brain by studying persons with a     history of TBI including but not limited to: amateur and professional athletes, active and     veteran members of the armed forces, as well as victims of motor vehicle and work accidents,     and physical battery/domestic violence.      This project aims to expand these findings to the population at large. Identification of the     syndrome is critical for identifying potential individuals who are most likely to benefit     from potential prevention and treatment.   "
98020|NCT02003170|"     The purpose of this study is to systematically evaluate the results of medical investigations     to identify symptom and biological patterns and common etiologies of neurodevelopmental     disorders.   "
98026|NCT02003079|"     Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the     cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous.     CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a     result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function     properly, which can lead to recurrent infection and swelling of the sinus walls. When     symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis     (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain     or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of     individuals in Canada and has been found to be associated with poor quality of life. In the     CF population the life expectancy is increasing but chronic disease like CRS is becoming     increasingly prevalent. Investigators currently do not know the impact that CRS has on the     health-related quality of life in adults with CF and how many suffer from symptoms. The     investigators aim to determine the impact of CRS among adults with CF, in order to gain a     better understanding of chronic disease among these individuals. The investigators strongly     feel this research will improve the referral processes between Respirologists and     Otolaryngologists, thereby improving treatment and quality of life for patients.   "
98027|NCT02003066|"     Investigators hypothesized that goal-directed fluid therapy using stroke volume variation     will improve postoperative recovery in patients undergoing free flap reconstruction after     head and neck cancer resection. Investigators will compare the effect of goal-directed fluid     therapy using stroke volume variation on recovery in patients undergoing free flap     reconstruction after head and neck cancer resection.   "
98028|NCT02003053|"     Inspiratory muscle training (IMT) is an intervention used with success in the outpatient     setting within the COPD population. Use of IMT is also theoretically possible during     mechanical ventilation. This study will determine if the IMT excercise will increase Maximum     Inspiratory Pressure and will also assess the feseability and safety of the study.   "
98029|NCT02003040|"     The purpose of this study is to investigate the utility of Venus 1000 in predicting 30-day     hospital readmissions for acute decompensated heart failure. Secondary outcomes will include     correlation with NT-proBNP and weight both at admission and discharge from hospital   "
98030|NCT02003027|"     The aim of this prospective non-randomized study was to assess the efficacy and safety of     endomyocardial botulinum toxin injection in left ventricle for preventing episodes of VT     Storm.   "
98031|NCT02003014|"     To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos     tablets) in combination with biguanides (for 12 months after the start of pioglitazone     tablets treatment) in patients with type 2 diabetes mellitus.   "
98032|NCT02003001|"     The aim of this prospective non-randomized study was to assess the efficacy and safety of     endomyocardial botulinum toxin injection in left ventricle for preventing ventricular     arrhythmias.   "
98033|NCT02002988|"     The aim of this prospective non-randomized study was to assess the efficacy and safety of     endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left     atrium for preventing drug-resistant paroxysmal atrial fibrillation.   "
98034|NCT02002975|"     This study is designed to determine the onset of new cerebral and cardiovascular events and     changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on     long-term pioglitazone (Actos Tablets) treatment.   "
98035|NCT02002962|"     The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum     toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the     radiofrequency ablation of atrial flutter.   "
98036|NCT02002949|"     The purpose of this randomized study is to determine if the home SDHD is a suitable     alternative to conventional dialysis performed in a dialysis center for patients suffering     from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD).      The adequacy of this alternative dialysis technique confirms that the SDHD at home is a     viable option for patients coming from HAPD/CAPD and indeed support the clinical benefits of     home SDHD compared with those of conventional dialysis: lowering blood pressure and lower use     of antihypertensive drugs , improving the quality of life, maintenance of residual renal     function related to a reduced risk of death and reduction in operating costs of dialysis and     patient transport.   "
98037|NCT02002936|"     This is an extension study to investigate long term safety and efficacy of SyB C-1101 when     orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who     have completed 6 cycles in the study 2012002 whose purpose is to investigate tolerability of     SyB C-1101 when administered orally in patients with recurrent/relapsed or refractory     myelodysplastic syndrome.   "
98038|NCT02002923|"     The investigators have conducted a prospective, double-blind, randomized study to assess the     comparative safety and efficacy of two different treatment strategies, PVI only versus PVI     plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed after     follow-up of at least 1 years with the use of an implanted monitoring device (IMD).   "
98040|NCT02002897|"     The study aims at evaluating the efficacy of the fractional carbon dioxide laser as a new     modality for treatment of localized scleroderma and to compare its results with the well     established method of UVA 1 phototherapy.   "
98041|NCT02002884|"     The purpose of this study is to determine whether injections of Botulinum toxin type A into     muscles of one or both arms alone or in combination with injections into one or both legs are     effective and safe in treating children/adolescents (age 2-17 years) with increased muscle     tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.   "
98057|NCT02002676|"     Patients in critical illness frequently present hypermetabolism， which can extremely increase     the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely increased     REE will improve ICU patients' outcome   "
98058|NCT02002663|"     The aim of the study is the identification, comparing continuous infusion of local     anesthetics and steroids intralesionally with the current gold standard therapy (PCA), of the     effective dose of local anesthetics and steroids within 7 days following abdominal surgery in     order to halve the consumption of opioids and give the best pain control with a lower     incidence of side effects and persistent chronic pain (at 1 and 3 months) We also plan to     measure the peripheral inflammation and oxidative stress by analyzing the pro-inflammatory     cytokines and anti-inflammatory properties.      Another objective is to investigate the combined effect of polymorphisms of genes related to     pain sensitivity, and the correlation with the development of the inflammatory response and     the incidence of chronic post-surgical pain (CPSP), which will be considered to validate the     genotype-phenotype correlations.      The intralesional catheter will be placed within the operating field by the surgeon at the     end of the procedure.        -  first postoperative 24 hours: ropivacaine 0.2%-methylprednisolone 1 mg/kg/die infusion          (10ml/h) in the wound. Rescue dose with morphine via intravenous PCA (0.5 mg/ml, bolus 1          mg, lock-out 5 min, max 20 mg in 4 hours)        -  from 24 hs to 48 hs: ropivacaine 0.2%-methylprednisolone 1 mg/kg/die infusion (10ml/h)          or saline 0.9% 10 ml/h in the wound. Rescue dose with morphine via intravenous PCA (0.5          mg/ml, bolus 1 mg, lock-out 5 min, max 20 mg in 4 hours) . from 48 hs to 7th day:          ropivacaine 0.2% or saline 0.9% via patient controlled intralesional analgesia (PCIA) (2          mg/ml, bolus 20 mg, lock-out 60 min, max 80 mg in 4 hours). Rescue dose Tramadol 100 mg.      The first assessment will be by the anesthetist pre-operatively, to verify the patient     eligibility.      All patients will be evaluated at the end of surgery (T0) and after 3-6-12-24-36-48 hours     after surgery. Further evaluations are scheduled every 24 hours until the seventh     postoperative day. At each assessment will be recorded: Numeric Rating Scale (NRS) at rest,     NRS at movement (NRSm) - defined as pain at deep inspiration and cough - ; blood pressure,     heart rate, respiratory rate, nausea (PONV scale), need of rescue analgesics and presence of     any complications.      On the 7th postoperative day, the patient will be reassessed by both pain clinicians and     surgeon; the surgeon will remove the catheter.      At 1 month and 3 months after surgery, the patient will be evaluated through phone interview     to investigate pain persistence.      Inflammatory response analysis will be performed on the first 15 patients in each group (for     a total of 30 patients). Before awakening of the patient the surgeon will insert a     microdialysis catheter in the fat adjacent to the surgical wound with sterile technique. The     microdialysed liquid will be collected in dedicated tubes directly in the infusion pump. The     sample of the first hour will be discarded to avoid that microtrauma of catheter positioning     influences the study. Sampling will be performed every 6 hours the first day, and every 12     hours in the second and third day. Serum samples will be collected to compare systemic with     regional samples. All samples will be stored at -80 ° C until sampling. Concentrations     quantification of different cytokines will be analyzed by ELISA Parma Unit will analyze VNTR     (variable number of tandem repeats) polymorphism of the ADRB2 gene, directly related to the     risk of chronic persistent postoperative pain development; Pavia Unit will take care of     genotyping of polymorphic sites in the following genes: OPRM1 (mu-opioid receptor 1), COMT     (catecholamine O-methyl transferase), UGT2B7 (UDP-glucuronyl transferase), IL1Ra (interleukin     1receptor alpha). From the blood samples will be extracted DNA and RNA using standard     procedures. RNA will be retained for possible future studies on the expression of genes of     interest. The DNA will be used instead for the study of genetic polymorphisms.      In this study the formation of free radicals, particularly superoxide will be assessed     together with lipid peroxidation in both serum and urine, The 8- deoxyguanosine and     Poly-ADP-ribose polymerase (PARP), the presence of nitrotyrosine.      Blood samples and urine tests will be carried out before the start of surgery , before the     bolus of morphine and local anesthetic , at 24 h after the end of the intervention and 48 h     after end of the intervention   "
98042|NCT02002871|"     Monocenter, randomized, intraindividual, open label, exploratory study comparing 4 weeks of     treatment with 453nm blue light with no treatment in patients with Eczema. Patients will be     screened up to 28 days before start of treatment. During the screening visit, the purpose and     procedures of the study will be explained to potential patients and informed consent will be     obtained. In addition, fungal superinfection of the target area will be examined using direct     preparations and mycology cultures. At the baseline visit, patients with Eczema will be     determined and all inclusion and exclusion criteria will be assessed. For eligible patients,     two comparable treatment areas will be randomized to treatment with blue light (target area)     or to serve as untreated control area. After randomization, patients will receive treatment     of the target area with 3 applications per week at the investigational site for a total     treatment period of 4 weeks. During those 4 weeks, safety and effectiveness assessments will     be performed at weekly intervals. After end of treatment, the patients will be followed-up     for another 2 weeks. In case no full resolution of adverse events occurred at the 2 week     follow-up visit, a follow-up call will be performed after another 2 weeks. Treatment     responses will be photo documented   "
98043|NCT02002858|"     The primary aim of this research study is to enhance smoking cessation outcome among smokers     with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An     educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An     integrated smoking cessation, and anxiety and depression management treatment program (SDAT).     Both treatments also utilize nicotine replacement therapy.   "
98044|NCT02002845|"     A retrospective multicenter investigation of the use of the da Vinci® Surgical System in     Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and     effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor     procedures.   "
98045|NCT02002832|"     A randomized, double-blind, double-dummy, parallel-group and multicenter study to investigate     lurasidone in treatment of schizophrenia compared with risperidone   "
98046|NCT02002819|"     Patients with Alzheimer's disease (AD) can have seizures in addition to losing their memory     and other mental functions (referred to as cognitive functions). The seizures, and other     examples of overactive electrical activity in the brain that is not noticeable, contribute to     the loss of cognitive function. Studies in animal models of AD suggest that a drug that     prevents seizures called levetiracetam may reduce neuronal over-excitation and improve     cognition. Based on this evidence, the investigators propose to determine if levetiracetam     can be used to treat patients with AD. The investigators developed novel instruments for this     population that will also be used in future large-scale clinical trials.      The current study will last for 12 weeks and will involve people with AD. Participants will     be initially examined with an overnight brain wave study to assess for silent epileptic     (seizure-like) activity. Presence of epileptic activity on the screening exam is not required     to enter the trial. Participants will then be assigned to groups in a randomized manner. One     group will receive levetiracetam for 4 weeks, then no drug for 4 weeks, and then placebo for     4 weeks. For another group, the order of treatments will be reversed. The cognitive abilities     of participants will be retested every 4 weeks and compared to those at the beginning. The     cognitive tests include a virtual-reality navigation test of memory and computerized tests of     mental flexibility and problem solving. The participants will be monitored with a     magnetoencephalogram (MEG) with simultaneous EEG (M/EEG) at each visit. M/EEG is a highly     effective non-invasive method for identifying brain regions of epileptic activity. The     investigators will need to recruit 36 randomized participants to test the study hypotheses.     This study will take place at the University of California, San Francisco (UCSF) Memory and     Aging Center, which is a large referral site for dementias, and the Department of Radiology.     The overall goal of the study is to demonstrate that levetiracetam provides cognitive benefit     in AD, particularly in patients who have silent epileptic activity.   "
98047|NCT02002806|"     This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo     for pain control in subjects with pancreatic cancer.   "
98048|NCT02002793|"     This study aims to standardized the process of mini-invasive abdominal draniage of SAP in     early stage.To determine the indications and occasion.   "
98049|NCT02002780|"     This research project has two goals. The first goal is to find one or more questionnaires     that can accurately identify children who are experiencing high levels of stress or emotional     health issues during a regular clinic visit. The second goal is to find out whether children     who are experiencing stress or emotional health problems are able to attend a day camp     programme and complete activities at home that are designed to help them cope better with     stress. We also want to find out if the day camp and home activities are helpful.   "
98050|NCT02002767|"     This study is to evaluate the single-dose pharmacokinetics (PK), safety, and tolerability of     GS-5816 in participants with severe renal impairment using matched healthy participants as a     control group.   "
98051|NCT02002754|"     This study aim is to observe the response to Bambuterol Hydrochloride tablets treatment in     subjects with eosinophilic bronchitis .      The investigators hypothesize:      A few of subjects with EB have some responses to Bambuterol Hydrochloride tablets therapy.      Most of subjects with CVA respond well to Bambuterol Hydrochloride tablets therapy   "
98052|NCT02002741|"     The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to     ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.   "
98053|NCT02002728|"     The purpose of this study is to evaluate a methodology for detecting early forming cavities     in children that is more accurate and reliable than the gold standard used by dentists around     the world. The new method uses an electrical current device to detect early enamel mineral     loss before it can develop into a cavity. The manual gold standard is for a dentist to probe     the surfaces of the teeth with a fine pick, searching for areas of defect.   "
98085|NCT02002312|"     To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with     advanced clear cell renal cell carcinoma using RECIST criteria.   "
98086|NCT02002299|"     The purpose of this study is to investigate the invasive front in growth mode (expanding or     infiltrative) and dedifferentiation (tumor budding) and comparing these with the tumor     surface (polypose or flat) + / - ulceration in surgical specimens at colorectal cancer.   "
98054|NCT02002715|"     This study aims to observe the therapeutic effect of different treatment course with inhaled     corticosteroids in eosinophilic bronchitis patients.      The investigators hypothesize:        1. Cough score will be improved after treatment with longer treatment course with inhaled          corticosteroids in EB patients.        2. The sputum eosinophil percentage will be decreased and recovered to normal level          (Eos%<2.5%) with longer treatment course with inhaled corticosteroids in EB patients.        3. The rate of recurrence after treatment will be decrease with longer treatment course          with inhaled corticosteroids in EB patients   "
98055|NCT02002702|"     This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety,     tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and     30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy,     in approximately 45 Japanese AHF patients.   "
98056|NCT02002689|"     The purpose of this signal seeking study is to determine whether treatment with LDE225     demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic     malignancies to warrant further study   "
98059|NCT02002650|"     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in     high risk patients was considered a standard method to prevent PEP. However, the risk     factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just     for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to     determine whether routine using of rectal indomethacin is more effective than the conditional     strategy.   "
98060|NCT02002637|"     The objective of this study is to evaluate the safety and technical feasibility of implanting     the Latella Implant System in the treatment of patients with medial osteoarthritis of the     knee.   "
98061|NCT02002624|"     The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the     clinical and radiologic results of primary total knee arthroplasty (TKA) using     patient-specific versus conventional instrumentation.   "
98062|NCT02002611|"     The purpose of this study is to evaluate a pharmacokinetic drug interaction between     lobeglitazone and warfarin in healthy subjects.   "
98063|NCT02002598|"     This study is designed to define dose-limiting toxicity and determine preliminary evidence of     efficacy of Carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients     with newly diagnosed multiple myeloma (MM).   "
98064|NCT02002585|"     Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use     of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney     disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Renal     denervation is a modern endovascular method used to treat resistant hypertension. The method     is being extended to other groups of patients, where the sympathetic tone is increased beyond     resistant hypertension. Because of the character of the disease, we hypothesize that renal     denervation can reduce or prevent progressive deterioration of kidney functions in this     patient population. The aim of this clinical study is to show that renal denervation has     protective effects on the progression of chronic renal insufficiency.   "
98065|NCT02002572|"     The SIMOVI project is a collaboration between our Department of Maxillofacial Surgery (CHU     Amiens) and the Biomechanical bioengineer Research Department and Roberval Labs     (Technological University of Compiègne). The question raised is the extent to which a facial     mimic can be evaluated objectively. In today's clinical practice, the investigators use     grading systems based on muscular scale or testing, in order to evaluate a facial muscular     disorder. This assessment remains subjective because the investigators are deducing from     surfacing cutaneous deformations the movement quality of the solicited muscle.      This qualitative approach is therefore an approximate approach and deserves to be better     thought to plan a surgical treatment which involves mimic facial muscle (as rehabilitation of     facial palsy, cleft palate for example), to monitor the results, and to follow the recovery     and progress in physiotherapy care.      The aim of this study is to correlate external soft tissue movement (essentially cutaneous)     during facial mimic with internal movement (essentially facial mimic muscle) using     qualitative and QUANTITATIVE indicators, and to perform a biomechanical model of selected     mimic face's movement using the precedent data.   "
98066|NCT02002559|"     This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for     diagnosis of early esophageal cancers among high risk patients.   "
98067|NCT02002546|"     1. In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I          as measured by the i-STAT immunoassay reliably identifies and excludes an acute          myocardial infarction.        2. In chest pain patients with suspected acute coronary syndrome whose baseline troponin is          above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured by          the i-STAT immunoassay accurately discriminates between acute myocardial infarction and          non-acute myocardial infarction troponin elevations.   "
98068|NCT02002533|"     This randomized phase II trial studies how well brief behavioral therapy works in improving     sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep     disorder counseling may reduce fatigue and insomnia as well as improve the well-being and     quality of life in patients with breast cancer who are undergoing chemotherapy.   "
98087|NCT02002286|"     This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T     cell immune activation and immune activation in HIV-infected immunological non-responders.     The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV     immunological non-responders.   "
98088|NCT02002273|"     The objective of this randomized study is to compare the effect of two controlled chest tube     protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or     segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous     studies have suggested that the amount of negative pressure used at the level of the chest     drainage device may affect the duration of air leak, but the results have been inconsistent,     however as revealed in more recent studies understanding of the physics of chest drainage     devices may have been confounded by lack of regulation of the pleural pressure.      In addition, experimental studies have shown that fluid drainage may be affected by the     degree of negative pleural pressure applied.   "
98069|NCT02002520|"     Pain is the way our brain interprets certain bodily sensations. It is very difficult to     describe or to put into words as perception and tolerance of pain varies widely between     individuals. It is known that age, gender and past experience and memory of past experience     all contribute to patients' feelings of discomfort and tolerance of pain, but the reason why     some patients actually do not experience any pain at all post surgery is still unknown.      Because pain affects every person at some point in their lives, it is of utmost importance     that we can find more effective analgesic methods, and provide analgesia tailored to an     individual's need as well as discovering new methods which may be able to identify those     individuals who are more prone to suffering serious, or chronic pain. It has been proposed     that epigenetic modifications may play a role in sensitivity to analgesia and response to     trauma, such as post surgery. The effects of epigenetic changes on key genes and the role     this plays in analgesia sensitivity and pain perception is deserving of further research.      Epigenetics is a growing field of study in which there are genetic modifications that do not     involve changes to base sequences in a gene, but that result nonetheless in changes to gene     expression. It has long been known that changes in gene expression play an important role in     the establishment of pain states. But it is not known whether a priming injury can induce     lasting epigenetic marks which would result in an increase in both postoperative acute pain     and the risk for chronic pain. Only by fully understanding these epigenetic mechanisms will     we be able to offer better drugs for the treatment of pain, and to identify those at high     risk of postoperative pain and postsurgical chronic pain.      The purpose of this study is to determine whether severity of pain following surgical     procedures, such as third molar surgery is related to baseline methylation status of the     promoter region of IL-6 and TNF-α and changes in methylation status post surgery.   "
98070|NCT02002507|"     Our hypothesis is that there will be a decrease in internal jugular venous flow in the park     bench position when compared to the supine position. There will also be a change in blood     flow between the right and left internal jugular veins in the park bench position. In     particular, there will be a greater reduction of flow on the dependent side. However, the     internal jugular venous flow will be the same in both the prone and supine positions.   "
98071|NCT02002494|"     Our hypothesis is that there will be a decrease in internal jugular venous flow in the park     bench position when compared to the supine position. There will also be a change in blood     flow in the between right and left internal jugular veins in park bench position,     particularly there will be a greater reduction of flow on the dependent side. However, the     internal jugular venous flow will be the same in both the prone and supine position.   "
98072|NCT02002481|"     Investigation of the influence of narrowness and unusual circumstances on the CPR-quality   "
98073|NCT02002468|"     Denmark has a higher incidence of cervical cancer than other Nordic countries, although all     Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or     asymptomatic invasive cancer.      Annually 40 000 women receives an abnormal or inadequate test result and a follow-up     recommendation.      However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical     Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress     into cancer.      Delayed follow-up is found in situations where women either consciously or unconsciously     postpone follow-up, or because of organizational aspects of the screening program, where     communication regarding test results can fail either in content or with delay.This study will     evaluate two interventions designed to increase follow-up:        1. A letter with the test result and potential recommendation for follow up will be sent to          the women (RCT). The intention is to ensure that all women will be notified about the          test result, quickly, homogenously and in layman's written language, still with the          opportunity to contact or be contacted by the general practitioner, if there is special          needs. Furthermore, it is assumed that general practitioner consultations regarding          delivery of normal test results will decrease, so that cost savings is a potential side          benefit        2. Electronic reminder to the general practitioner if women have not had the recommended          follow up, giving the general practioner´s an opportunity to remind the women (retro          perspective cohort study).      The results will be of great importance to the future organisation of cervical and colorectal     cancer screening programmes in Denmark, but will also have international interest because of     their similar challenges.   "
98074|NCT02002455|"     Prostate cancer (PCa) is currently the most common neoplastic disease among men in     well-developed countries with 350 000 new cases diagnosed annually in Europe and 4 800 in     Finland. Due to widespread use of serum prostate specific antigen (PSA) in asymptomatic men,     most patients present initially with localized disease. Radical prostatectomy, radiotherapy     (RT) and active surveillance are the most common management options for patients with     localized PCa. Proper preoperative staging for patients with adverse features on biopsy who     are candidates for radical prostatectomy is urgently needed. For elderly men external beam RT     is the preferred modality which can be safely performed utilizing modern techniques such as     intensity modulated and image guided radiotherapy (IMRT and IGRT). Since randomized studies     suggest a dose response effect beyond 78-80 Gy newer techniques aim at dose escalation     provided that toxicity can be controlled. Therefore, ultra high dose IMRT/IGRT requires     visualization of intracapsular disease which will receive the highest dose. Taken together,     the use of accurate anatomical and functional imaging modalities are essential for planning     both nerve sparing radical prostatectomy and ultra high dose IMRT/IGRT Fluorine-18 labeled     L-leucine analogue 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) has shown to     preferentially accumulate in PCa and its nodal metastases. By assisting in localization of     intraprostatic and pelvic disease FACBC with hybrid positron emission tomography/computed     tomography (PET/CT) or magnetic resonance imaging (PET/MRI) has potential to improve     selection of patients for robot-assisted radical prostatectomy and IMRT/IGRT.      Anatomical MRI at 1.5 Tesla (T) compared with transrectal ultrasound has demonstrated a     higher sensitivity for tumor detection but almost the same specificity, stressing the need     for additional metabolic MRI. Advanced application of MRI such as proton magnetic resonance     spectroscopy (1H MRS), diffusion weighted imaging (DWI) and dynamic contrast enhanced imaging     (DCE-MRI) are increasingly being used for detection and characterization of PCa. The use of     3T scanners and multiparametric MRI (mpMRI), consisting of anatomical MRI, DWI, 1H MRS and     DCE-MRI, demonstrated very promising result for staging and detection of PCa.   "
98075|NCT02002442|"     The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse     with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or     saline solution on bacterial contamination in the buccal vestibule when used preoperatively     using the real-time Polymerase Chain Reaction (qPCR).      We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in greater     reduction of bacterial counts than with essential oil-based, cetylpyridinium chloride, or     saline mouthwashes.      The secondary aim of this study is to evaluate the effect of the tested mouthwashes in     reducing the bacterial counts over time.      We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in a     reduction of bacterial counts for longer duration than with essential oil-based,     cetylpyridinium chloride, or saline mouthwashes.   "
98089|NCT02002260|"     This study is a randomized clinical trial comparing the levonorgestrel intrauterine system     (LNG-IUS) to combined oral contraceptives (COCs) for treatment of heavy menstrual bleeding.     This study is designed to be conducted within the context of a patient's     standard/usual/typical care from their primary gynecologic care provider. We hypothesize     that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related     quality of life and will be associated with fewer treatment failures and greater     cost-effectiveness at one year. To test these hypotheses, we plan to enroll 59 women from     several sites who present for gynecologic care and self-report heavy menstrual bleeding into     a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy     menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic     disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or     COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.   "
98076|NCT02002429|"     Background: Facet interventions are the second most commonly performed procedure in pain     clinics throughout the U.S, including in the military. Currently, there is no clear consensus     regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve;     MBB) are the best way to diagnose and treat facetogenic pain, or even whether or not to     perform diagnostic/ prognostic blocks.      Hypothesis: IA blocks will provide better relief than MBB, but MBB may better select patients     for radiofrequency denervation.      Purpose: Objective 1: Determine which prognostic block is the best predictor for RF     denervation outcome; Objective 2: To determine whether adding steroids to IA or MBB may     provide intermediate or long-term benefit to a subset of individuals.      Research Design: Randomized, comparative-effectiveness study      Methodology /Technical Approach: A total of 225 patients with non-radicular chronic low back     pain (LBP) with suspected facetogenic etiology will be randomized in a 2:2:1 ratio to one of     3 groups:      Group 1 will receive IA blocks with steroids and LA Group 2 will receive MBB with steroids     and LA Group 3 will receive MBB with only saline      Those individuals who obtain significant (≥ 50% in groups 1 and 2,3) but temporary (<     1-month) relief will undergo radiofrequency (RF) denervation at their 1-month follow-up. In     group 3, those patients who do not experience pain relief at 1-month will undergo RF     denervation regardless of the pain relief they experience (as many practitioners in the     military and civilian practices do without diagnostic blocks).1-3 Participants in Groups 1     and 2 who experience prolonged relief from their diagnostic/ therapeutic blocks with LA and     steroids will not undergo RF denervation until their pain returns. Those individuals who     experience prolonged relief lasting > 6 months will be given the option of repeating the     diagnostic/ therapeutic block. In Groups 1, 2 and 3 patients who experience prolonged relief     from the diagnostic blocks, follow-up visits will be at 1-month, 3-months and 6-months after     the block, or until their pain relief wears off. In those who undergo denervation based on a     positive block, follow-ups will be performed 1, 3 and 6-months after the denervation provided     they continue to experience significant (> 50%) relief at each follow-up. Those individuals     who fail to experience significant relief after denervation will be unblinded and exit the     study per protocol.   "
98077|NCT02002416|"     The MET oncogene encodes the receptor tyrosine kinase (RTK) for hepatocyte growth factor     (HGF) and controls genetic programs leading to cell growth, invasion and protec¬tion from     apoptosis. Although the definitive role of MET oncogene is yet to be determined in     carcinogenesis of gastric cancer, overexpression and amplification of c-Met has been     demonstrated in gastric cancer cell lines. In addition, approximately 10-20% of gastric     cancer tissues and up to 40% of the scirrhous histological subtype were shown to harbor     increased MET gene copy numbers. Importantly, PHA-665,752, a selective c-Met kinase inhibitor     showed significant reduction of established tumor mass in mouse xenografts with GTL16, a     gastric cancer cell line with >10-fold MET amplification. Another pivotal study showed that     gastric cancer cells with MET amplification were extremely sensitive to PHA-665,752 and     implicated a potential role of c-Met protein in developing theranostics in gastric cancer.     More and more data indicated that c-Met was an important prognostic factor in gastric cancer.      Gastric cancer is a heterogeneous disease. Does the expression and amplification of c-Met in     the primary lesion differ from the metastatic disease? Does the expression and amplification     of c-Met in the early disease differ from advanced disease? Till now there is no related     report.      Purposes:        -  Compare the expression and amplification of c-Met between primary lesion and metastatic          lesion together with clinical characteristic, to explore the relationship of c-Met          expression and metastatic pattern        -  Compare the expression and amplification of c-Met between early stage and metastatic          stage, and to explore the role of c-MET in the development of carcinoma   "
98091|NCT02002234|"     A single-centered, randomized, controlled clinical trial comparing standardized medical care     alone with standardized medical care and decompressive hemicraniectomy to determine the     effectiveness of decompressive surgery more definitively in patients with clinical signs of     infarction of the Middle Carotid Artery (MCA) territory.   "
98078|NCT02002403|"     The drug being tested in this study is low doses of Optina (formerly known as Danazol)     (DMI-5207) that may be an effective treatment for diabetic retinopathy and diabetic macular     edema (DME). Laboratory studies have demonstrated that low doses of this drug may treat     diabetic retinopathy and diabetic macular edema by two important ways, decreasing blood     vessel permeability (related to leaking and edema) and by decreasing the formation of new     leaky blood vessels. Optina is not approved by Health Canada for the treatment of diabetic     macular edema but higher doses of Optina are approved by Health Canada for treatment of     endometriosis (growth of cells similar to those that form inside of the womb that grows     outside of the womb) and fibrocystic breast disease (a condition of the breast tissue).     Higher doses of Optina have also been approved in the United States and many other countries     since the mid-1970s in the treatment of men and women with hereditary angioedema (a disease     which causes swelling in parts of the body) in addition to endometriosis and fibrocystic     breast disease in women.      All of the Optina doses that will be used in the current study are less than half of the     typical starting doses for the approved indications. This can be compared to high-dose     aspirin that is used to treat, for example, headache, while low-dose baby aspirin is used     to reduce blood clotting. Similarly, Optina has two different effects at high and low dose.     The low doses for this study have been selected based on the laboratory studies mentioned     above.      The purpose of this study is to investigate the safety and effectiveness of low doses of     Optina in the treatment of macular edema due to diabetes, and also to test if it helps to     slow the development of macular edema.   "
98079|NCT02002390|"     Stroke is one of the main severe disease of public health importance. Increasing evidence     suggests that inflammatory mechanisms plays a significant role in stroke. So, immune targets     are supposed to be an effective one. The sphingosine-1-phosphate receptor regulator     Fingolimod(FTY720)is an effective immunology modulator which has been widely used in     autoimmune disease and has been testified effective on stoke animal models.   "
98080|NCT02002377|"     SHIFT-2 is a national, multi-center, non-randomized, open label trial of aflibercept in     patients with wet age related macular degeneration who have incomplete response with     routineranibizumab treatment.   "
98081|NCT02002364|"     In patient who are predicted to be difficult to intubate with a standard direct laryngoscope     well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i).     Patients are randomly assigner to a single- or a multiple- use flexible optical scope.      We hypothesize that intubation is obtained equally effective with both types of flexible     scopes   "
98082|NCT02002351|"     This monocentric registry should provide information on the extent how patients with     pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment.     The data may provide a basis for further prospective studies showing the treatment of     patients with pulmonary diseases especially by physical activation.   "
98083|NCT02002338|"     A study to research the post-operative results according to the chosen surgical technique and     evaluate the refractive changes before and after the excision of pterygium.   "
98084|NCT02002325|"     The purpose of this study is to clarify efficacy and safety of MRI-based intravenous     thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having     acute ischemic stroke with unknown time of symptom onset.   "
98090|NCT02002247|"     The aim of the investigators' research program is to investigate the effects of perioperative     high dose selenium supplementation in high-risk cardiac surgical patients undergoing     complicated open heart surgery. The investigators hypothesize that the therapeutic strategy     tested in this randomized trial may contribute to a fewer complications, less organ injury     and fewer deaths. Before the investigators conducted the large definitive trial, they     conducted a pilot study to assess the feasibility of the protocol, and are rolling the pilot     patients into the definitive trial.   "
98092|NCT02002221|"     The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid     add-on therapy to improve overall glycemic control in patients with T2DM inadequately     controlled by insulin, with or without concomitant metformin treatment. It was agreed with     PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety     data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.   "
98093|NCT02002208|"     The purpose of this study is to determine whether OC000459 is in reducing disease severity     and preventing flares in people with moderate to severe atopic dermatitis (AD).   "
98094|NCT02002195|"     Elderly patients are generally underrepresented in the study populations of combination     chemotherapy trials. In gastric cancer patients, oxaliplatin has shown a more favorable     toxicity profile than cisplatin. A combination chemotherapy of 5-fluorouracil (5-FU) with     oxaliplatin, mainly FOLFOX regimens, has been investigated in numerous phase II studies,     using different doses and schedules, and has shown considerable antitumor activity. Insofar     as toxicity is concerned, significant toxicities, including myelo-suppression and peripheral     neuropathy, are a major issue for elderly patients. A modified FOLFOX regimen by omitting the     administration of bolus 5-fluorouracil have shown a good profile of activity and tolerability     in the elder population. This study evaluates the efficacy and safety of a modified FOLFOX (m     FOLFOX) regimen for up to 8 cycles followed by capecitabine maintenance in elderly patients     with metastatic gastric cancer and presenting associated disease(s)   "
98095|NCT02002182|"     Some cancers may be related to an infection with a virus, such as the Human Papilloma Virus     (HPV). HPV related Oropharyngeal cancer (HPVOPC) accounts for 80% of oropharynx cancer cases     in the United States. HPVOPC has better prognosis than patients with HPV negative oropharynx     cancer. In many hospitals, the standard of care treatment for oropharyngeal cancer is surgery     and/or radiotherapy with or without chemotherapy. While chances of survival for most patients     with HPVOPC is very good, current treatments are associated with short- and long-term side     effects which can be severe. In pre-clinical research using animal models of cancer,     vaccination targeting the HPV virus has been found to cause tumor regression. Thus,     approaches which target the unique characteristics of HPV-infected cancer cells, such as     therapeutic vaccination, are attractive strategies for potentially reducing radiotherapy and     chemo radiotherapy regimens (and thus decreasing toxicity) and enhancing long-term disease     control.      The purpose of this study is to see if an experimental vaccine, ADXS11-001, is effective in     stimulating the body's defense system against HPV-positive oropharyngeal squamous cell     carcinoma before transoral (through the mouth) surgery. The experimental product ADXS11-001     uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically     modified such that the risk of getting an infection is significantly reduced. Several     research studies have already been conducted with ADXS11-001 in men and women with cancer. So     far, approximately 675 doses of ADXS11-001 have been given to 263 patients with HPV     associated cancers.   "
98096|NCT02002169|"     Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis     (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit     showering but not increase infection risk.      Research question: Is it feasible to conduct a randomized control trial comparing the rate of     CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC     care alone with 6 month follow up? Study Design: This pilot study is a multi-centre     randomized control trial. Eligible participants will be randomized to STP versus standard     care after meeting predefined criteria to confirm healed tunneled CVC exit site.      Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the     CRB rate documentation in the satellite setting, percentage of patients screened, recruited,     educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated     patients in the control arm).      Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south     central Ontario, Canada.      Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit sites.      Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each     measure of feasibility has its statistical threshold for success. If the threshold is reached     in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible.      Discussion: A pilot feasibility study of the larger study is critical due to the potential     challenges associated with recruitment, compliance and contamination.   "
98097|NCT02002156|"     The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent     tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more     effectively to a subsequent infection with TB.      Many studies have shown that BCG is effective in reducing deaths from TB disease,     particularly in children. However, there is also evidence that in countries with a relatively     high death rate, BCG reduces this death rate but by more than would be expected by its effect     on TB alone. This controversial but important finding warrants further and serious     consideration. One possibility is that BCG, in addition to stimulating the immune system     against TB, also has a positive effect on the way the immune system works more generally.     This might mean a more effective response to serious infections that are completely unrelated     to TB, or the ability to respond better to other routine childhood vaccines, or to maintain     such responses for longer. In these examples, the timing of BCG administration in relation to     other vaccines could be crucial.      This study will recruit 30 healthy babies who would not routinely be offered the BCG vaccine     in the UK within the first week of life. Babies will be assigned at random to one of three     groups of ten babies each. BCG will be given to one group of babies around birth, one at     three months old and the last group will not get BCG during the study. Babies will stay in     the study until 13 months old and have five blood tests over this period.      This preliminary study will look at the participants' blood to see if there are differences     in the immune system, or its response to the MenC childhood meningitis vaccine or the pattern     of genes activated after BCG has been given.   "
98147|NCT02001506|"     Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and     sequential treatment of anthracyclines followed by taxanes, which has shown superior     pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now.     Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3     cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01     trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable     efficacy and further reduce the duration of neoadjuvant chemotherapy.   "
98098|NCT02002143|"     Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in     those aged over 65 years. Treatment such as medication, healthy nutritional choices & body     weight management, as well as physical activity can reduce the impact of diabetes.      Older patients with type 2 diabetes can potentially benefit from Group Appointments, in which     8-12 patients share one appointment of about 60-120 minutes with a team of health     professionals.      The team of investigators (3 people) will see the 'Group' 4 times/yr for two years. Their key     measure of success will be control of glycosylated hemoglobin - HbA1C.      To address their primary and secondary research objectives the investigators will focus upon     patients aged 65 years or older who have T2DM and who are being treated with oral     hypoglycemic agents and diet, or diet alone.      The investigators will compare patients randomized to (A) eight Group Appointments over a 24     month period (i.e., 4 per year), led by a primary care physician [Intervention] with, (B)     patients randomized to eight traditional one-to-one usual care appointments also provided by     a primary care physician (Individual Appointment; [Control]). The investigators will compare     (A) and (B) on selected clinical, patient-rated, and economic outcome measures.      SIGNIFICANCE: Seven Canadian provinces already have Group Appointment billing codes for     physicians who lead Group Appointments. If the study's proposed health care innovation     demonstrates benefits, it would be possible to 'roll out' / 'scale up' the model province- or     nation-wide in Primary Care settings.   "
98099|NCT02002130|"     Type I Diabetes is an auto immune disease in which the body's immune system attacks and     destroys the insulin-producing beta cells of the pancreas. Therefore, children affected by     this condition present with high blood sugars. This condition affects 1:400/500 persons     worldwide.Type I Diabetes, previously known as Juvenile Diabetes,usually strikes in     childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there has been     no treatments that can arrest, or reverse the ongoing beta cell destruction. We hypothesize     that GABA, a naturally occurring substance, has the potential to reduce the inflammation and     protect the pancreatic beta cells from autoimmune destruction. GAD-alum may contribute to the     preservation of residual insulin secretion in patients with recent onset, Type I Diabetes.   "
98100|NCT02002117|"     The logical next step is to integrate molecular profiling into the care of all patients with     NSCLC.   "
98101|NCT02002104|"     The replacement of autologous blood vessels by artificial grafts is urgently needed in     clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most     clinically used artificial blood vessels because of its chemical and mechanical stability.     But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts     have a high failure rate of 40% in three years in vivo because of the functional lack of an     intact endothelial cell layer. Here we developed a two-step modification including chemical     etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg.     cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE     grafts. Functional peptide immobilization significantly increased the adherence and growth of     HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to     evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days     implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were     demonstrated by SEM and histological analysis. These preliminary data showed the potential to     grow an intact endothelial layer to improve the patency rate of the modified ePTFE grafts.   "
98102|NCT02002091|"     -  It is a prospective,observational, cohort study        -  The main purpose of the study is to assess the prevalence of diabetic chronic          complications in newly diagnosed type 2 diabetics in suburban area of Algiers.        -  The secondary purpose is to study the impact of diabetic renal complications as a risk          factor on the atherothrombotic events.   "
98103|NCT02002078|"     Corrosive substance ingestion in childhood is a public health issue in developing countries     and several management protocols were proposed to prevent esophageal strictures. The role of     corticosteroids in preventing corrosive-induced strictures is controversial. The     investigators' aim is to study the influence of high doses of corticosteroids to prevent     esophageal strictures.   "
98104|NCT02002065|"     The purpose of this follow-up study is to evaluate the five-year immune persistence of one     injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.   "
98105|NCT02002052|"     Concurrent chemoradiotherapy is the standard treatment for locally advanced, unresectable     non-small cell lung cancer, but carries a risk of radiation pneumonitis of approximately 30%,     and is associated with a decline in pulmonary quality of life.      Standard radiation planning aims to optimize dose to the anatomic lung volume, without     consideration of the differences in regional lung function. Functional lung avoidance     radiotherapy aims to reduce radiotherapy dose to regions of functioning lung, instead     depositing dose in areas of lung that are not well-ventilated. Functional lung regions are     determined using noble-gas MRI and co-registered to the radiotherapy planning CT scans.     Functional lung avoidance radiotherapy has been demonstrated to be feasible, and this trial     aims to compare outcomes between standard radiotherapy (with concurrent chemotherapy) vs.     functional lung avoidance radiotherapy (with concurrent chemotherapy).   "
98106|NCT02002039|"     Whether Erythropoietin improves the neurological outcomes of neonates with perinatal     asphyxia.   "
98107|NCT02002026|"     This trial will address the effect of uterine artery ligation during Cesarean section in     cases with placenta previa to decrease blood loss.   "
98108|NCT02002013|"     Translating reliable evidence on fluid resuscitation of intensive care patients into clinical     practice - Improving patient outcomes and containing public health costs   "
98141|NCT02001584|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and     obese (Part B), otherwise healthy subjects.   "
98132|NCT02001701|"     Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is     due to an abnormal separation of the vitreous gel from the surface of the retina and macula.     The current, gold-standard treatment for this condition involves surgery performed in the     operating room that involves risk such as bleeding, infection, cataract, and retinal     detachment. It has been previously shown that a less invasive intravitreal injection of a gas     bubble performed in the office may also treat vitreomacular adhesion with less risk than     surgery.      The purpose of this study is to determine the effect of an office-based injection of an     intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.   "
98109|NCT02002000|"     Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in     general practice. The possible causes are numerous and sometimes nonspecific. In some cases,     the etiologic investigation of patients with non-systematized and chronic musculoskeletal     pain can not highlight any organic cause. Several studies have shown a link between these     symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D <     20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D     supplementation with few side effects. Nevertheless, it remains unknown and vitamin D     deficiency is rarely considered as a possible etiology in patients with chronic pain. We     hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal     pain and deficient in vitamin D could improve painful symptoms. We aim to perform a     double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain     improvement after vitamin D supplementation.   "
98110|NCT02001987|"     This two part, multi-center, open-label, single-arm study will evaluate the efficacy and     safety of RoActemra/Actemra as a monotherapy or in combination with non-biologic disease     modifying antirheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid     arthritis who have an inadequate response or are intolerant to non-biologic DMARDs or     biologic therapy. 162 mg RoActemra/Actemra will be administered once a week by subcutaneous     injection for up to 76 weeks.   "
98111|NCT02001974|"     This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile of     orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal growth     factor receptor-2) negative metastatic breast cancer patients.   "
98112|NCT02001961|"     This will be a cross-sectional, observational study.      Null hypothesis:      There is no difference in the amount of extracellular volume (ECV or scarring) in the hearts     of patients with heart failure as compared to control subjects.      Heart failure occurs when the heart muscle has become too weak to work properly. It is     associated with an increase in the amount of connective tissue (collagen) which replaces dead     heart muscle cells (scarring). Currently a biopsy of the muscle is the only way to measure     the amount of scarring. This is invasive and rarely done in children. Because of this, it is     difficult to measure the amount of scarring in a particular patient or disease process, which     is important for improving our understanding and treatment of the disease.      Cardiac magnetic resonance imaging (MRI) is a non-invasive imaging tool which is routinely     used to look at areas of local scarring in heart muscle. Because the scarring is so     widespread in paediatric patients, we have not been able to use this method previously. Now     new imaging techniques allow us to look at widespread scarring but these have not yet been     validated in children.      We plan to use late gadolinium enhancement (T1 mapping) to measure the amount of scarring in     patients with heart failure (we have evidence that their heart biopsies show increased     amounts of scar tissue) and children having MRI scans for other reasons. We will use measures     of function including echocardiography and 6 minute walk test to compare to the amount of     scarring. This will help us to know whether the amount of scarring will be clinically useful.      We will look at the amount of various proteins in the blood of patients and control subjects     which are related to the scarring and cell death processes. We already use blood tests to     monitor heart failure and these tests may help us to refine our testing and improve timing of     treatment (e.g. transplantation).      This study will help us to design further research in this field.   "
98113|NCT02001948|"     The aim of this study was to compare the effects of two different doses of intrathecal     morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block     regression times, postoperative analgesia and the severity of side effects, for inguinal     hernia repairs.   "
98114|NCT02001935|"     The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms     effect metabolism of theophylline in chronic obstructive pulmonary disease patients.   "
98115|NCT02001922|"     Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory     disorder characterized by acute exacerbations that contribute to physical impairment and     increased healthcare use and costs. Given the increasing burden of this disease in terms of     morbidity, disability, mortality and costs, innovative care models centered on patients and     aiming at improving quality and comprehensiveness of care are needed. Effective     implementation and evaluation of chronic disease management - integrated care(CDM-IC)     programs, in the real world context is of great importance.      Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and     effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of     Valais.      Design: The evaluation plan of this study will combine both quantitative (controlled     before-after study design) and qualitative methods (focus groups with COPD patients and     practicing healthcare professionals).      Setting: French-speaking part of the canton of Valais.      Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease,     non-institutionalized and residing in the canton of Valais. The control group of patients     will be constituted of age and gender-matched COPD patients from the Swiss COPD cohort study.      Measures:      Quantitative part:      Primary outcomes: Generic and disease-specific health-related quality-of-life and all-cause     hospitalizations (past 12 months)      Other outcomes:        1. Processes of care        2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC          instrument)        3. Measure of self-efficacy (intermediary outcome)        4. 6-minutes walking test, nb of COPD exacerbations, % of current smokers        5. Healthcare utilization: unscheduled ambulatory care visits        6. Care satisfaction        7. Measures of the process of implementation of the intervention      Qualitative part: At 12 months: conduct of two focus groups of participating COPD patients,     and of two focus groups of participating healthcare professionals.   "
98116|NCT02001909|"     To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy     male subjects   "
98117|NCT02001896|"     This 2 arm study will compare the efficacy and safety of treatment with erlotinib     intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage     IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR)     Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and     cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day     15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib     monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease     progression, and the target sample size is 60 individuals.   "
98118|NCT02001883|"     The primary objective of this study is to compare the efficacy and tolerability of low-dose     statin therapy vs. the association between a low-dose statin and a nutraceutical-based     protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be at     high-risk.   "
98142|NCT02001571|"     The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the     body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s)     with mild or moderate hepatic impairment and matched control Participants with normal hepatic     function.   "
98119|NCT02001870|"     As age increases the chances for a woman to become pregnant decrease as well spontaneously as     through assisted reproductive technologies (ART). For the treatment of unexplained     infertilities two techniques can be used: intra-uterine insemination (IUI) and in vitro     fertilization (IVF). The aim of the present study is to compare the efficiency in term of     delivery rate of IUI and IVF in couples in whom the female age is over 37 years.   "
98133|NCT02001688|"     To evaluate different doses of Kamada-API for Inhalation on the levels of alpha     1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to     assess the safety of the treatment in subjects with Alpha-1 Antitrypsin Deficiency.   "
98485|NCT01997073|"     Specific Aims: 1) Measure exhalation enthalpy in patients receiving conventional positive     pressure ventilation during stable hemodynamic conditions. 2) Measure exhalation enthalpy in     patients following change from two-lung ventilation to one-lung ventilation while minute     ventilation remains constant.   "
98120|NCT02001857|"     Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node     involvement in prostate and bladder cancer. The main complication of PLND is development of a     lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal     edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence     of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between     12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in     surgery for improvement of haemostasis and to promote tissue sealing. They could reduce     lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge     itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to     prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing     transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer     surgery.   "
98121|NCT02001844|"     Modern modular foot-orthoses systems allow an integration of the cost and efficiency benefits     afforded by the use of pre-formed semi-rigid FOs components, while simultaneously allowing a     high degree of individualisation of prescription. Such systems, while popular, still remain     unproven. Recent studies in paediatric rheumatology have made a contribution in developing     guidelines with regards to pharmacological intervention in arthritic children. In addition,     specific drug therapy protocols have been published to effectively help general     practitioners, physiotherapists and ophthalmologists to successfully treat children with JIA     patients (BSPAR 2006; Hull 2001; NICE guidelines 2002). A Cochrane systematic review on     treatment of pes planus, highlighted that children with JIA were excluded as a group from     most of the studies (Ashford et al. 2005). At present little evidence exists for the     podiatric management of children affected by this disabling pathology, especially for     orthotic management. This research has provided evidence to support the use of readily     available off-the-shelf FOs in treating JIA children.   "
98122|NCT02001831|"     The aims of the present study are:      i. To conduct a population study of body composition, muscle function and ability to     undertake activities of daily living in elderly Irish individuals      ii. To investigate the effect of a six month period of nutrition supplement support on lean     tissue mass, and muscle and cognitive function in individuals aged 70 to 80 years.   "
98123|NCT02001818|"     The treatment of CML and the expected survival has been revolutionised since the introduction     of tyrosine kinase inhibitors (TKIs) such as nilotinib. Despite their effectiveness, these     drugs will never totally remove CML affected cells from the body. In order to achieve this     goal, and potentially enable CML patients to live without the daily need for TKIs, other     features of the patient's immune system may need to be harnessed. One possibility is using     externally administered interferon (IFN) to augment the response induced by the TKI.      This study will assess the response in terms of length of survival, detection of minimal     disease levels and time until disease worsens in patients with chronic phase CML who are     taking nilotinib and pegylated Interferon. Patients will commence taking nilotinib for 3     months, and once tolerated, will simultaneously be treated with injected pegIFN for up to 2     years. Patients can continue taking nilotinib beyond this time providing they are receiving     benefit. Options are available for patients to decrease or increase their dose or to switch     to another TKI, imatinib, to ensure a balance between drug effectiveness and minimal side     effects is achieved.   "
98124|NCT02001805|"     The investigators wish to compare very active runners in healthy untrained control subjects     on a number of parameters.      The project aims to understand the underlying mechanisms by which physical inactivity causes     diseases. This the investigators will study the full spectrum of physical activity, from the     most inert of the most active people. The investigators have already collected muscle     biopsies and established stem cells from people with Type 2 diabetes, obese healthy and     normal weight healthy. In this study, the investigators will establish a cohort of highly     physically active marathon runners. In a case-control design, the investigators compare     muscle stem cell function across the entire spectrum of physical activity / inactivity.   "
98125|NCT02001792|"     The purpose of this study is to determine the effects of patient positioning during     colonoscopy on patient safety and diagnostic outcome.   "
98126|NCT02001779|"     Stenting the malignant biliary obstruction is considered to be the preferred palliation     modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical     indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated     the safety and technical feasibility of an irradiation biliary stent insertion in patients     with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in     relieving jaundice and extending survival when compared to a conventional biliary     stent.However,the small sample size,the population distribution of two groups will influence     the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric     study was designed to prospectively compared the responses to the treatment with this     irradiation biliary stent versus the conventional biliary self-expandable stent in patients     with inoperable malignant biliary obstruction.   "
98143|NCT02001558|"     The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure     ulcers compared to sterile saline among persons with spinal cord injury.   "
99899|NCT01978535|"     This study is designed to investigate whether the treatment of non-anemic iron deficiency     with intervenous iron sucrose will result in decreased symptom reporting and improved     cardiovascular indices in adolescents (age 12-21) with Postural Orthostatic Tachycardia     Syndrome (POTS).   "
98145|NCT02001532|"     Background      The prevalence and incidence of type 2 diabetes is increasing globally. A common complication     of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders     like myocardial infarction, stroke and kidney failure. Methods to detect early subclinical     stages of macro-vascular disease are not yet available in a clinical setting.      Hypothesis      Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic     information when evaluating risk profile for patients with diabetes type 2.      Aim      The aim of the project is to investigate the association between arterial stiffness and the     occurrence and development of vascular complications in patients with type 2 diabetes.     Specifically we want to investigate:        1. in a cross-sectional study, the association between arterial stiffness and subclinical          atherosclerotic changes in the coronary arteries assessed by computed tomography (CT)          and        2. in a longitudinal study, the predictive value of arterial stiffness on the development          of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and          nephropathy assessed by urine analysis.      Methods      The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100     age- and sex matched controls. The study participants were enrolled between 2008-2011 and     extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white     matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we     will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned     measurements. Furthermore, CT is used to investigate the coronary plaque burden of the     participants (Agatston Score and Segment Involvement Score).      Results and Perspective      This project adds new insight into arterial stiffness as a predictor of the progression of     micro- and macrovascular complications in patients with type 2 diabetes, and can potentially     improve risk stratification and early strategies of intervention in this patient group.   "
98127|NCT02001766|"     Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor     tissue perfusion and function as well as an increased risk of cardiovascular events. ATP,     which is released from the red blood cells, contributes to the regulation of the blood flow     and studies have shown that red blood cells taken from T2D patients have an impaired ability     to release ATP. However, it is not known whether the changes in the ATP system is an     underlying cause of the poor tissue perfusion observed in T2D. The purpose of project 1 is to     test the hypothesis that the deterioration in blood flow in T2D is caused by a reduced     release ATP from red blood cells, and to test if pharmacological manipulation of cAMP will     normalize ATP release, plasma ATP levels and thereby blood flow.      Furthermore, epidemiological studies show a clear link between regular exercise and a reduced     risk of serious cardiovascular disease. The extent to which a physically active lifestyle may     improve endothelial function in T2D is unknown. Regular physical activity improves     vascularization and induces an anti-inflammatory environment. Both the angiogenic and     anti-inflammatory effects of physical activity is in part mediated by substances released     from the active muscle. These muscle-derived substances are classified as myokines and have     paracrine, autocrine and endocrine effects and may thereby affect distant tissues. The     purpose of the project 2 is to investigate whether high intensity interval training may     reverse endothelial dysfunction in T2D through increased release of ATP and myokines. In     individuals with T2D we will determined blood flow in the muscle tissue using advanced     ultrasound. In addition, using intravascular and intramuscular microdialysis we will     determine ATP levels in blood and in the muscle interstitium.   "
98128|NCT02001753|"     Magnetic resonance (MR) imaging is a widely used and well-established noninvasive medical     diagnostic imaging tool. By using a static and a gradient magnetic field in combination with     a radiofrequency field (RF), MR provides excellent contrast among different tissues of the     body. Although long-term effects on human health from exposure to strong static magnetic     fields seem unlikely, acute effects such as vertigo, nausea, change in blood pressure,     reversible arrhythmia, and neurobehavioural effects have been documented from occupational     exposition to 1.5 T. Cardiac MR (CMR) imaging requires some of the strongest and fastest     switching electromagnetic gradients available in MR exposing the patients to the highest     administered energy levels accepted by the controlling authorities. Studies focusing on     experimental teratogenic or carcinogenic effects of MR revealed conflicting results. Since     CMR is emerging as one of the fastest growing new fields of broad MR application, it is of     particular concern that a recent in vitro study with CMR sequences has reported on     CMR-induced DNA damages in white blood cells up to 24 h after exposure to 1.5 T CMR.     Therefore, we hypothesized that CMR can induce the damage of endothelium and endothelial     progenitor cells in type 2 diabetes   "
98129|NCT02001740|"     Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to     affect 25% of the general population. Many forms of treatment have been advocated for frozen     shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid,     manipulation under anesthetic and arthroscopic releases. There is no general agreement in     favour of one form of treatment, and the response to a particular treatment varies in     different series. A few randomized controlled trials appear in the literature. Most of these     showed improvements with steroid use, but the results were not always statistically     significant. One randomized control trial reported superior results in favor of arthrographic     joint distension with steroid compared to a saline placebo. To our knowledge there have been     no other similar randomized trials to support these results. The objective of this study is     to determine if arthrographic distension of the shoulder joint with steriods is an effective     treatment modality for adhesive capsulitis as compared to injection with local anesthetic and     contrast alone. The study design is a placebo-controlled, double blind clinical trial where     participants will undergo distension arthrogram of the shoulder and be randomized to receive     either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and     contrast alone.   "
98130|NCT02001727|"     Aims:        1. Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on the          prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on dyspepsia          related health-care consumption and quality of life.        2. To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination          of these conditions and the effect on quality of life, prognosis and dyspepsia-related          health care expenditure.      Methods:      In 1998-99 20.000 individuals, age 40-65 years, identified by their civil registration     number, were allocated by a computerized randomized procedure to HP-screening group and     control group. All participants received a questionnaire at inclusion, 1-year and 5-year and     now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life. In     addition we will obtain information from registers on, comorbidity, use of endoscopies and     prescription medication. An economic evaluation is done alongside the randomized trial.      The primary unscreened group is invited to HP test (13C-urea breath-test) in order to analyze     the effect of HP-screening according to HP-status      Expected results:      The study will provide information on the long-term effect of HP-screening and eradication in     a population. The study will provide information about the long-term effect on incidence of     peptic ulcer in an aging population that is likely to have an increased consumption of ASA     and NSAID. Furthermore the study will generate knowledge about the long-term prognosis of     dyspepsia and reflux in the population (dyspepsia and reflux. Preliminary results from the     5-yr follow-up (13) showed that is has a great influence on quality of life and the     dyspepsia-related health care consumption, whether the individual has solely reflux, solely     dyspepsia or a combination of both symptoms.      Long-term follow-up and further analyses of these findings could have great impact on     management and treatment of individuals with symptoms. It is important to focus on groups; in     which the symptoms have the greatest influence on quality of life of the individual. This     finding has not been displayed in other studies.   "
98131|NCT02001714|"     This three-site randomized controlled trial compares the effectiveness and cost-effectiveness     of a group-administered behavioral treatment program to no treatment. Women with stress,     urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated     clinically at each of three study sites, and random assigned to one of two treatment arms: 1.     Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential     to reach a larger population of older women with urinary incontinence, not only in the     traditional medical settings, but also in community settings. The investigators hypothesize     that group behavioral treatment will be more effective than no treatment. The investigators     hypothesize that the group treatment will be cost-effective compared to no treatment.   "
98146|NCT02001519|"     Achievement of pathologic complete response is important prognosticator to predict long term     outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to     be investigated whether addtional pathologic complete response is achieved for those triple     negative breast cancer patients who recieved 4 cycles of adriamycin with     cyclophosphamide(AC4) but did not reach clinical complete response during the course of     neoadjuvant therapy.   "
98134|NCT02001675|"     Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring,     maintaining and/or enhancing muscular performance. From a practical point of view, NMES can     elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism) or     by the recruitment of motoneurons in the spinal cord through the depolarization of sensory     axons (central mechanism). It is noteworthy that NMES parameters widely affect the balance     between transmission along these two pathways. Conventional NMES is usually delivered using     short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and high stimulus     intensities so that the large antidromic volley in motor axons ensures that the evoked     contraction will be driven largely by the direct depolarization of motor axons beneath the     stimulation site with no or little involvement of central nervous system. On the contrary,     when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to 100 Hz)     (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism and the     corresponding force (recently referred to as extra force) is significantly (three times)     larger than the conventional NMES-induced force. This extra force is supposed to represent     the central contribution from the recruitment of spinal motoneurons by the evoked afferent     volley given that no additional force was observed during a complete anesthetic block of the     nerve proximal to the stimulation site. Despite the obvious differences in terms of     activation of the neuromuscular system between conventional and WP-HF NMES, the functional,     metabolic and cortical responses associated to both protocols remain to be determined   "
98135|NCT02001662|"     The investigators want to explore the analgesic effect of Adductor Canal Blockade (a     peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The     investigators hypothesize that the nerve block will have an abrupt analgesic effect.   "
98136|NCT02001649|"     Suicidal behaviors is known to aggregate in families. The purpose of this study is to     evaluate association between common polymorphisms in genes important for neurobiological     pathways linked to suicidal behaviors and suicide attempt among adolescents patient.   "
98137|NCT02001636|"     Obese patients, who underwent bariatric surgery, are at risk to develop protein malnutrition.     The aim of this study is to evaluate the influence of postoperative protein supplementation     on weight reduction, body composition and protein status.   "
98138|NCT02001623|"     The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed     population of patients with specified solid tumors   "
98139|NCT02001610|"     Commercial probiotics can be delivered in numerous forms. The two most common delivery forms     are similar to the two product formats to be tested. It has been demonstrated using in vitro     testing that probiotic organisms that are unprotected from gastric exposure may not survive     that exposure and therefore may not remain viable throughout the rest of the GIT.     (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro     testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule     will survive gastric exposure. It is anticipated that this difference in in vitro gastric     survivability will translate to improved digestive tract survivability that can be     demonstrated using fecal recovery techniques.      The commercial product to be tested in this clinical trial has been in the market for over 17     years. However, it is not known what effect this commercial product has on the commensal     probiotic population in the gut and particularly in the lower bowel where much of probiotic     benefits are believed to be largely realized. Also, it is not known what effect the     commercial product has on the total commensal microbiota or fecal pH. While commercial     probiotic products have been largely aimed at benefits related to improved health, they also     have the potential to change overall gut microbiota (probiotics as well as all others)     composition and activities. Learning what happens to the overall gut microbiota can be a     helpful step in establishing the potential health benefits of the probiotic class of     organisms in the test products.   "
98140|NCT02001597|"     Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment     for prostate cancer. The state of the art radical prostatectomy involves a robotic     laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D     visualization of the surgical site and improved dexterity over standard laparoscopic     instruments. While the long term prognosis of prostate cancer patients who undergo radical     prostatectomy has improved significantly over the past two decades, there remain significant     rates of disease recurrence and complications.      The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be     deployed and used easily during surgery, can be registered to the robot coordinate systems     with high accuracy, and can be controlled from the surgeon's console, in order to improve the     visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer     probability map that can be used to make decisions on surgical margins.      The investigators objectives are        1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical          prostatectomy        2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate and          peri-prostatic tissue from the surgical console      This is an observational study; trans-rectal ultrasound will be used to visualize the     prostate and periprostatic structures during surgery but the standard of care will not be     affected by this ultrasound imaging.   "
98144|NCT02001545|"     RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study     which will include patients hospitalized for ACS within 24 hours of symptom onset and who     have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or     non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the     short-term (at the end of the first month after index event) antithrombotic management     patterns in a real-life setting for patients hospitalized with an acute coronary syndrome.   "
98148|NCT02001493|"     Antiangiogenics are the mainstay of treatment in patients with metastatic renal cell     carcinoma. Conventional clinical end-points, used to measure efficacy with chemotherapeutic     agents, have not been helpful in monitoring the efficacy of antiangiogenic therapy.     Increasing numbers of predictive and pharmacodynamic biomarkers are being investigated that     are useful surrogates for clinical response and also to identify patients early on who will     benefit from this class of agents. This is valuable in avoiding unnecessary toxicity in     patients and also in reducing cost implications of this expensive group of drugs.      The investigators wish to explore the variability of baseline metabolomic profile in the     blood and urine of patients with mRCC and characterise the inter-subject and intra-subject     variability. The study of the baseline levels has not been performed in this cohort     previously. This is extremely important in interpreting the emerging data of changes in the     levels of the various biomarkers from various trials. This will in turn help in the     development of future targeted therapies, especially Phase I/II studies where an early     demonstration of target modulation is vital. This study will also help to identify the number     of patients required for appropriate statistical evaluation in pharmacodynamic studies to     assess biological activity, optimisation of dosing, and investigation of potential mechanisms     of resistance. Study of the urinary and blood metabolomic profile in conjunction will give us     an insight into the potential use of urine as a diagnostic and prognostic tool.      OBJECTIVES GOAL The main objective of the study is to determine the change from baseline in     metabolomic profiling in patients with clear cell renal cell carcinoma 1 month after     nephrectomy or antiangiogenic treatment during 2 months   "
98149|NCT02001480|"     Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic     nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest that     beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population.     However, no results from large-scale clinical outcome trials with beta-blockers exist in this     patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be     justified due to potential harmful side-effects such as AV-block or hypotension. In addition,     we are lacking identified ECG surrogate parameters for SCD in this high-risk population and     on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions.      Therefore, the present study will identify surrogate parameters of SCD in hemodialysis     patients with T2DM and in an interventional trial investigate the suppressive effect of     beta-blockers on these identified ECG markers.   "
98150|NCT02001467|"     Simulation-based training lead to improvements in learning compared to no intervention but     little is known of the effects on organizational improvements that are relevant to patient     care. This study focused on the effects of training midwives in performing cervical     ultrasound scans on continuity of care when managing pregnant women with symptoms of     premature onset of labor. Our hypothesis is that simulation-based training can be used to     decrease the number of shifts in primary responsible health care practitioner as midwives     that are trained in cervical ultrasound scans may manage the patient encounter without     engaging a second practitioner (i.e. an obstetrician).   "
98151|NCT02001454|"     The purpose of this study is to compare attitudes and knowledge of the staff of various     departments in our Medical Center in regards to pain treatment. With the results of our     survey we will then draw up a protocol on pain management.   "
98152|NCT02001441|"     This project will examine the relationship between physical activity levels, brain structure     and memory function in adults with Mild Cognitive Impairment (MCI) aged 60 to 75. The study     will follow 30 adults with age-associated memory impairment or MCI over the course of 18     months. During this time, subjects' physical activity levels will be measured regularly and     related to both the thickness their hippocampus and to their memory performance. Subjects     will be recruited and screened for major health problems at UCLA. Physical activity will be     tracked for two weeks using accelerometers at baseline and every 6 months during the study.     At baseline and at the end of the study, subjects will undergo a structural MRI brain scan to     measure hippocampal thickness, as well as a neuropsychological evaluation to measure memory     function. The study will seek to determine the relationship between physical activity level,     hippocampal thickness and memory performance in older adults with age-associated memory     impairment.   "
98153|NCT02001428|"     The purpose of this study is to assess the effectiveness of different malaria control     strategies in the first year of life.      The effectiveness of delivering an intermittent screening and treatment programme with     dihydroartemisinin-piperaquine (DHP), linked to local immunization programmes, will be     compared to the current practice of passive case detection of malaria.      This study has two objectives:        1. To assess the effectiveness of intermittent screening and treatment with          dihydroartemisinin-piperaquine (DHP) administered at 2, 3, 4 and 9 months of age          compared with the current practice of passive detection and treatment for malaria in an          area with high drug resistance levels to both P. falciparum and P. vivax.        2. To evaluate the safety, efficacy and population pharmacokinetics of DHP in children          under 1 year of age.   "
98154|NCT02001415|"     The purpose of this study is to determine the efficacy of different lens treatments (normal     spectacle lens, ortho-K, & Myovision) on myopia control in Chinese adolescent patients.   "
98155|NCT02001402|"     A follow-up intervention for the climacteric symptoms of nurses in Peking   "
98156|NCT02001389|"     This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose-     and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting     phosphodiesterase 10 (PDE10)] by EVP-6308.   "
98240|NCT02000297|"     This study is conducted to determine whether a new synthetic bone substitute is better than     allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy in     terms of postoperative pain, postoperative bleeding, operation time and bone healing. The     investigators hypothesized the new synthetic bone substitute would bring better outcomes in     the outcome variables mentioned above.   "
98170|NCT02001207|"     In critical illness, patients are highly stressed and should have elevated cortisol (stress     hormone) secretion to adapt to stress. Dysfunction of this system is referred to as critical     illness-related corticosteroid insufficiency. Free cortisol (unbound form) which is mainly     responsible for its physiologic function is difficult to measure. We hypothesized that the     salivary cortisol, which can be obtained by noninvasive methods, can more accurately evaluate     adrenal function of critically ill patients.   "
98297|NCT01999556|"     The purpose of this study is to obtain high quality specimens for molecular studies for the     identification and characterization of genetic mutations involved in the pathogenesis of     familial myeloid malignancies. Specimens obtained will be de-identified, linked to basic     clinical data, and sent to Washington University (Division of Oncology, St. Louis, MO) for     molecular analyses. Some specimens sent to Washington University may also be used for quality     control analyses.   "
98157|NCT02001376|"     Background and Purpose: Fitness is the foundation for health and quality of life for     individuals. Recent changes in lifestyle and eating habit in Taiwan have significantly     increased the prevalence of metabolic syndrome that may lead to poor fitness and subsequent     coronary artery disease, cardiovascular disease and diabetes. Although workers at the     National Taiwan University Hospital (NTUH) have undertaken regular health fitness     examination, the examination did not include the posture and movement analysis and no     exercise intervention was provided to those with metabolic syndrome. This study is therefore     aimed to conduct comprehensive health fitness examination for workers at NTUH and to examine     whether exercise intervention could decrease the risk factors and enhance fitness in those at     risk or with metabolic syndrome. Methods: This study will consist of two parts. In the first     part, 1102 workers at NTUH will be administered comprehensive fitness examination (body mass     index, waist circumference, muscle strength, flexibility, balance, cardiopulmonary test, and     posture and movement analysis) and will be assessed with the Physical Activity Readiness and     the Perceived Musculoskeletal Pain Scale and the International Physical Activity     Questionnaire. Those workers who are at risk or have metabolic syndrome (N=240) will be     assigned into the control, home-based exercise, and intensive exercise group with 80 in each     group with their will. The home-based exercise group will receive exercise instruction     biweekly for three months; the intensive exercise group will receive moderate aerobic     exercise and strengthening exercise three times a week for three months. The other workers     who are insufficient fitness status (N=240) will be assigned into the control, home-based     exercise, and intensive exercise group with their will. The home-based exercise group will     receive exercise instruction biweekly for a month; the intensive exercise group with 80 in     each group will receive moderate aerobic exercise and strengthening exercise three times a     week for a month. Descriptive statistics will be used to estimate the prevalence of 1, 2 and     ≧3 metabolic risk factors, and poor fitness. One-way analysis of variance (ANOVA) will be     used to examine the relation between metabolic syndrome risk factors and fitness. One-way     ANOVA will be used to compare the demographic characteristics of the control, home-based     exercise, and intensive exercise group. Two-way ANOVA repeated measures will be used to     examine the metabolic syndrome risk factors and fitness in the three groups across time.     Clinical relevance: Our results will help understand the health fitness of workers at NTUH     and will assist in establishing effective exercise program for those at risk or with     metabolic syndrome.   "
98158|NCT02001363|"     The investigators planned to research the cardioprotective effects of intravenous liraglutide     on reperfusion injury.   "
98159|NCT02001350|"     To use carotid ultrasound to screen 20-30 patients with longstanding or resistant     hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish     a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and     will give insight into the prevalence and specific location of carotid plaque at the     bifurcation in this patient population.   "
98160|NCT02001337|"     The purpose of this study is to create a prospective cohort of subjects with increased     probability of being diagnosed with pancreatic cancer and then screen this cohort for     pancreatic cancer   "
98161|NCT02001324|"     This is an observational study to determine the effect of various treatments prescribed by     healthcare providers for heavy menstrual bleeding on bleeding related quality of life (as     measured by the Menstrual Bleeding Questionnaire) and to compare electronic and paper-based     modes of data collection.   "
98162|NCT02001311|"     This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in     orthodontic patient to reduce caries risk and the possible consequential effect of this use     on the orthodontic brackets used for the treatment.      The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in     orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic     brackets.   "
98163|NCT02001298|"     The purpose of this study is the comparison of the cardiovascular effects of remifentanil and     nitroprusside for controlled hypotension   "
98164|NCT02001285|"     The purpose of this study is the comparison of the effect-site concentration of remifentanil     for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial     intubation during propofol-remifentanil total intravenous anesthesia.   "
98165|NCT02001272|"     The current standard of first-line chemotherapy in advanced ovarian cancer is the combination     of carboplatin AUC 5mg/mL/min and paclitaxel 175 mg.m-². This combination is feasible in     selected elderly patients such as those included in prospective trials. These trials,     however, include a minority of the elderly population. In wider selection of patients >70     years old, the standard carboplatin-paclitaxel regimen has been shown to induce an excess of     toxicity and premature treatment stopping. For elderly patients thought to be vulnerable and     at high risk of toxicity with the standard 3-weekly carboplatin-paclitaxel regimen, other     options are used in routine practice. One option is to delete paclitaxel and treat elderly     patients with carboplatin as a single agent. An alternative is to use the     carboplatin-paclitaxel regimen in a weekly schedule for both drugs such as reported by the     MITO (Multicentre Italian Trial in Ovarian Cancer).      To date, there is no randomized trial which could give us some evidence of how to select     patients who could benefit most of one or the other regimen described above. The 4th Ovarian     Cancer Consensus Conference has indeed recognised the medical unmet need of adapted therapy     for elderly patients with ovarian cancer and the necessity of additional research in this     population.      Recently, GINECO has described a Geriatric Vulnerability Score (GVS) in a population of     elderly patients with advanced ovarian cancer included in a specific multicenter phase II     trial. The best proportional hazard model fitting for overall survival identified the     following geriatric covariates score as being poor survival risk factors: ADL score <6, IADL     score <25, HADS score >14, albuminemia <35g/L and , lymphopenia <1G/L. GVS is the sum of     these risk factors for each patient. Using a cut off of 3, the GVS identified a group of     patients at high risk of severe toxicity, early cessation of treatment, unplanned     hospitalization and adverse outcomes.      This international multicentre randomized phase II trial will compare the success rate of     delivering 6 courses of chemotherapy with evidence of efficacy and without premature     termination for progression, death or unacceptable toxicity of three different chemotherapy     regimens in a selected population of elderly patients with a GVS ≥ 3:        -  Arm A: Paclitaxel 175mg/m²/3 hours, I.V. and carboplatin AUC 5, I.V. every 3 weeks        -  Arm B: Carboplatin monotherapy AUC 5 or 6 every 3 weeks        -  Arm C: Weekly paclitaxel 60 mg/m²/1 hour and weekly carboplatin AUC 2 (d1, d8, d15 every          4 weeks)      The total number of patients to be enrolled is 240, ie 22 in each arm (total = 66) at the     first step, then 58 more by arm (total=174) after interim analysis.   "
98166|NCT02001259|"     The purpose of this study is to determine efficacy of epidural steroid for postoperative pain     control after TKA   "
98167|NCT02001246|"     The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body     bridging (MBB) for anger management compared with the Real Deal anger management program, in     helping adolescents control or reduce their anger.   "
98168|NCT02001233|"     The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and     safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total     10,000 healthy infants volunteers aged from 6 to 35months old.   "
98255|NCT02000102|"     Patients with diabetic macular edema who were switched to aflibercept after having been     treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual     acuity and anatomic outcomes.   "
98169|NCT02001220|"     During weaning the work of breathing is transferred from the ventilator back to the patient.     Approximately 40% of the time on ventilators is spent weaning. Studies support the use of     screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to     identify weaning candidates. Once daily screening is the current standard of care. With     respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant     opportunity exists to screen patients more frequently, conduct more SBTs, and reduce the time     spent on ventilators and in the ICU.      The study is seeking to identify the optimal screening frequency to minimize patients'     exposure to invasive ventilation. The RELEASE Trial will evaluate a simple a simple     construct: more frequent screening will result In earlier identification of weaning     candidates, more frequent SBT's, and less time spent on ventilators and in the ICU. More     frequent screening is an appealing intervention because it is sensible, low risk, and     represents a cost effective use of current resources. This simple intervention holds promise     as a strategy that could change clinical practice, enhance the care delivered to critically     ill adults, and improve clinically important outcomes.   "
98171|NCT02001194|"     Employers are increasingly looking for opportunities to motivate sedentary employees to     become more physically active. Workplace walking programs have had mixed success and     typically show most improvement among participants that are already fairly active at a     baseline. The goal of this study is to determine whether a financial incentive program can     motivate sedentary employees to increase the number of steps they walk per day to meet a     minimum threshold.      Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or     more is achieved. We will assess outcomes each week for 3 months using incentives followed by     3 months of follow-up without incentives. Secondary outcomes will include the average steps     walked per day.   "
98172|NCT02001181|"     The study is being conducted to evaluate the efficacy, safety and tolerability of 2%     tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic     dermatitis compared to placebo (vehicle) BID for 4 weeks.   "
98173|NCT02001168|"     -  Lung cancer is one of causes of the malignant tumor-associated death on a global scale,          in which the surgery is the only effective approach in patients with non-small cell lung          cancer (NSCLC). As present, the total postoperative 5-year survival rate of NSCLC is          40%, while only 4%～15% patients can benefit from adjuvant chemotherapy[1]. American          National Comprehensive Cancer Network (NCCN) manual recommends that adjuvant          chemotherapy can be performed on NSCLC patients in phase Ⅱ～ⅢA.        -  In order to assure the necessity of adjuvant chemotherapy on NSCLC patients in phase ⅠB          or which kind of patients would benefit from it after the establishment of new staging,          a multi-subject group of lung cancer set up a perspective, randomized, open clinical          trial to explore whether adjuvant chemotherapy was effective on NSCLC patients in phase          ⅠB under new staging policy, and to collect the characteristics of patients who could          benefit from the treatment and the better adjuvant drugs after operation.   "
98174|NCT02001155|"     A test that was common in the 1960's and was used to detect primary open angle glaucoma was     the water drinking test (patients drank 1 quart of water to stress the fluid drainage     mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently     this test has been demonstrated as a predictor of peak eye pressure during the day. The     purpose of this study is to compare the results of the water drinking test between eyes that     have undergone trabeculectomy and eyes that have undergone tube shunt surgery.   "
98175|NCT02001142|"     One of the main objectives of this study will be to assess potential differences in important     risk factors associated with Metabolic Syndrome in overweight adults who do not participate     in a regular exercise program compared with overweight individuals who do exercise regularly.     In addition, we will determine the effects of a single, modest session of exercise on the     body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults     vs. obese adults who live a physically active lifestyle. Our study focuses on identifying     mechanisms responsible for improved insulin action related to regular exercise and to provide     novel targets for preventing and treating type 2 diabetes.   "
98176|NCT02001129|"     This study aims to examine the effectiveness of three different ways of helping patients     attend their recommended eye care appointments.   "
98177|NCT02001116|"     A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO     was established, for the implementation of a WHO Project to improve the quality of pediatric     care in the referral hospitals. The pilot regions selected for this intervention are the     three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH     project will be implemented at a first stage in a group of 10 pilot hospitals, randomly     selected among the existing hospitals in the above cited regions. Pilot Hospitals will be     compared to control hospitals, which are the hospitals in the region not receiving the     intervention, using a pre-defined set of indicators of quality of care. The results of the     present evaluation on the pilot hospitals will provide data that will inform the MOH on how     better to scale up this project at a national scale.   "
98185|NCT02001012|"     Preliminary studies have supported the background efficacy of local standard anti-malarial     medications in the treatment of uncomplicated knowlesi malaria, however there are no current     WHO treatment guidelines for this infection. There are both health cost benefits to a more     rapidly acting agent, and due to difficulties with microscopic identification there may be     more effective treatment for all malaria species if an aligned treatment guideline could be     supported. We are currently conducting a separate RCT using a similar protocol evaluating     artesunate-mefloquine versus chloroquine for uncomplicated P. knowlesi malaria. However     artemether-lumefantrine should also be compared against chloroquine due to the fact it is     also a first line anti-malarial recommended in Malaysia, and there are potential differences     in efficacy due to the different administration, absorption and half-life of     artemether-lumefantrine.      The investigators aim to test whether the fixed combination of artesunate-mefloquine is     superior to chloroquine in order to define the optimal treatment for both uncomplicated P.     knowlesi infection in both adults and children in this region.   "
98256|NCT02000089|"     Johns Hopkins clinical research office quality assurance group will monitor and audit this     study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal     monitoring at their site.   "
98178|NCT02001103|"     The specific aim of this project is to test if memantine add-on therapy will be helpful for     patients with first episode schizophrenia who present with or without cognitive impairments     and negative symptoms, to examine the efficacy and safety of memantine as an adjuvant agent     to their ongoing maintenance therapy with atypical antipsychotics. Our objectives include:        1. Test memantine add-on by 2 different dosages comparing to a placebo-controlled group of          clinically stable first episode schizophrenic patients who are under second-generation          antipsychotic maintenance therapy. The results will give us information regarding          effective dosage and the profile of adverse drug reactions while using on this          population.        2. Examine whether the effect of memantine add-on will be affected by any significant          baseline clinical variables or predisposed cognitive deficits. That is to say, if          memantine will only demonstrate adjunctive effect on those who are cognitively impaired          or its effect is independent from baseline cognitive functioning or the severity of          baseline psychopathology.        3. Examine the changes in negative symptoms as the secondary outcomes to see if such a          cognitive enhancing effect to be concurrent with an improvement in negative symptoms or          independent from changes in negative symptoms.        4. Treat the changes in positive symptoms and other clinical outcomes, such as readmission,          being employed/going back to school, and psycho-social functioning scores as the          tertiary outcomes to examine the effectiveness of memantine add-on.   "
98179|NCT02001090|"     This study examines the flow mediated dilation (FMD) of the brachial artery before and after     cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough     obstructing blood flow with a cuff around the forearm for five minutes. FMD is measured     before surgery and on the first morning after the operation.   "
98180|NCT02001077|"     This is a single-center, randomized controlled trial study design. Enrolled participants had     comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral     intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The     study intervention period lasted eight weeks. The objective of the study is to examine the     impact of two behavioral treatments on sleep and pain and to better understand what causes     chronic pain and chronic sleep disturbance.   "
98188|NCT02000973|"     The investigators designed a prospective, randomized, placebo-controlled study to determine     whether thoracic epidural anesthesia(TEA) with different local anesthetics has different     influences on the propofol dose during induction.   "
98181|NCT02001064|"     Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of     therapeutic results, the benefit of ART increases as adherence improves. Consequences of     suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and     more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous     co-occurring conditions and therefore take many medications making adherence to multiple drug     regimens more difficult. A mobile application capable of improving medication adherence among     HIV-infected persons would be highly useful.      The investigators propose an intervention study designed to address these potential     mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The     current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone     application titled Care4Today v2.0 versus standard of care to improve medication adherence     to ART over a 4-week period with 60 HIV+ participants.      The pilot RCT consists of 60 HIV+ persons who are at risk for ART medication nonadherence.     Using random assignment, 30 HIV+ participants will be assigned to medication adherence     improvement via Care4Today app as compared to 30 HIV+ participants assigned standard of     care.      The investigators will assess the effectiveness and acceptability of the app in improving     objectively measured ART adherence (i.e., via medication event monitoring system caps) over a     4-week period via a pilot RCT with 30 HIV+ persons assigned to the Care4Today intervention     and 30 HIV+ persons assigned to standard of care.   "
98182|NCT02001051|"     Background:      - Adrenal tumors are a common kind of tumor. Some of these secrete extra cortisol into the     body, which can lead to diabetes, obesity, and other diseases. Some people with extra     cortisol will show symptoms like bruising and muscle weakness. Others will show no signs.     This is called subclinical hypercortisolism. Some of these adrenal tumors become malignant.     Researchers want to know the best way to treat people with subclinical hypercortisolism. They     want to know if removing the tumor by surgery reduces the long-term effects of the disease.      Objectives:      - To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity,     osteoporosis, or cholesterol, and cancer detection.      Eligibility:      - Adults 18 and older with an adrenal tumor and high cortisol levels.      Design:        -  Participants will be screened with medical history, blood tests, and a CT scan.        -  Participants will have a baseline visit. They will have blood and urine tests and 7          scans. For most scans, a substance is injected through a tube in the arm. Participants          will lie still on a table in a machine that takes images.        -  Participants will have surgery to remove their tumor. Some will have surgery right away.          Some will have surgery 6 months later, after 2 follow-up appointments.        -  Participants will have 4 follow-up visits in the first year after surgery. They will          have 2 visits the second year, then yearly visits for 3 years. At each follow-up visit,          they will have scans and blood tests.   "
98183|NCT02001038|"     Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot     deformities are frequent complications in CMT patients and orthopaedic surgery is often     required. As yet there are no systematic studies on the management of orthopaedic     complications in CMT patients and the current approach varies between centres. This study is     a survey with the aim of understanding the current surgical approach to orthopaedic     complications in CMT.      The target population includes orthopaedic surgeons who perform surgical procedures for foot     deformities in CMT patients attending centres participating in the Inherited Neuropathies     Consortium (INC).   "
98184|NCT02001025|"     The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a     greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure     of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study     assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion     and edge dissection after ABSORB implantation compared to the XIENCE stent.   "
98186|NCT02000999|"     The purpose of this prospective study is to compare the diagnostic utility of two techniques     (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary     strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging     follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this     the investigators will ask study participants to have a small volume of fluid obtained from     the bile duct sent for additional testing at RedPATH. In some patients additional brushings     will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is     increased procedure duration).      The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity     and accuracy when compared to cytology +FISH in patients with biliary strictures.      Primary aim:      To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and     brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology     for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve     as the gold standard for diagnosis of malignancy.      Secondary aims:        1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH          and DNA analysis) are used.        2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with          cytology, FISH and DNA analysis.   "
98187|NCT02000986|"     This clinical trial studies dietary and exercise interventions in preventing cardiovascular     disease in younger survivors of childhood cancer. Eating a healthy diet and exercising     regularly may reduce the risk of cardiovascular disease in younger survivors of childhood     cancer.   "
98189|NCT02000960|"     Glucose transporter deficiency syndrome (Glut1-DS) is a form of pediatric epilepsy caused by     a genetic mutation that disrupts the body's ability to process food from the child's diet     into sugar (energy) needed to support brain function. Children with Glut1-DS experience     seizures that are not controlled by anticonvulsant medications, as well as delays in     cognitive and motor development. Currently, Glut1-DS is treated with the ketogenic diet, a     high-fat, low-sugar diet that provides the brain with an alternate source of energy. Despite     the significant improvement of seizures upon this diet, seizure control is incomplete in a     majority of children, and they continue to experience problems with brain development. Our     team of researchers and clinicians with expertise in metabolic diseases, neurology,     pediatrics, biochemistry, and genetics believes that there is an opportunity to achieve     CURE's goal of No Seizures/No Side Effects for children with Glut1-DS by investigating the     use of a new treatment option that is designed to compensate for the underlying biochemical     deficiency thought to contribute both to the seizures and to the impaired brain development     associated with Glut1-DS. The proposed treatment involves incorporating a special type of     oil, called triheptanoin, into the ketogenic diet as a way to make up for a specific     biochemical deficit affecting kids with Glut1-DS that the standard ketogenic diet fails to     address. Our goal is to do a pilot study to test the safety and effectiveness of this     promising new treatment option in a small group of children with Glut1-DS.   "
98190|NCT02000947|"     The purpose of this study is to determine if MEDI4736 will be adequately tolerated in     combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).   "
98191|NCT02000934|"     This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult     participants with advanced solid tumor and lymphoma malignancies. This study will be the     first to administer TAK-659 to humans. The participants population during dose escalation     (Part A) will consist of adults previously diagnosed with any form of a solid tumor or     lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no     longer effective. This first-in-human (FIH) study will include 5 dose expansion cohorts in     refractory and/or relapsed Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma     (DLBCL), indolent Non Hodgkin Lymphoma (iNHL), Mantle Cell Lymphoma (MCL), Post Transplant     Lymphoproliferative Disorder (PTLD) (Part B) following completion of dose escalation (Part     A).   "
98192|NCT02000921|"     The main focus of this study is to determine the use of nicotine-containing products across     the three experimental conditions. Subjects will be monitored to determine their continued     use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or     cessation of all tobacco containing products.   "
98193|NCT02000908|"     This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of     photobiomodulation therapy using the Realief Therapy system. The patients will be randomized     in a 3:4 ratio to treatment or sham arms.   "
98194|NCT02000895|"     Infants born preterm and of low birth weight are known to be at increased risk for early     onset of cardiovascular and renal disease in adult life. This has been related to low nephron     mass due to inadequate or early termination of glomerulogenesis in utero and during the     perinatal period. Risks for subsequent development of hypertension and kidney disease include     proteinuria, excessive weight gain during early life with insulin resistance and supplemental     high calorie feedings. The long-term goal is for early diagnosis of those infants who are at     risk for future development of hypertension and kidney disease so that the investigators     might intervene to potentially avert progression to adult disease. The objective of this     clinical trial is to acquire data on the natural history of neonatal kidney function and size     in infants born preterm during the first 2 years of life. This will be done through the use     of standard serum and urine markers as well as non-invasive ultrasound technology. The     central hypothesis of this clinical trial is that a subgroup of patients born preterm and of     low birth weight will demonstrate early markers of kidney injury including elevated serum     cystatin C, proteinuria and low kidney size. This hypothesis has been formulated on the basis     of preliminary data from our group studying this question retrospectively in older children     born prematurely who have developed overt kidney disease. The rationale for the proposed     research is to develop early serum and demographic markers of pre-clinical kidney disease so     that early intervention can occur. The proposed clinical trial is innovative because it will     investigate the risk factors for kidney dysfunction at a pre-clinical stage with the idea of     gaining more knowledge regarding therapeutic interventions. In addition, the study will     assess serum cystatin C as a surrogate test for glomerular filtration rate which could     indicate worsening kidney function at an earlier stage than serum creatinine.      The proposed research is significant because it is expected to identify at-risk patients for     future renal impairment and to prospectively monitor the persistence of proteinuria and its     effect on kidney function in the short term.   "
98195|NCT02000882|"     This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in     breast cancer patients with brain metastases.      Both capecitabine and BMK120 have previously shown activity in patients with breast cancer.     Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a     preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).   "
98230|NCT02000427|"     The primary objective is to evaluate the rate of complete remission/complete remission with     partial hematological recovery (CRh*) in adults with relapsed/refractory Philadelphia     chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive     blinatumomab.   "
98196|NCT02000869|"     People with CKD have higher prevalence of cardiovascular disease. The mechanism behind this     increased risk is complex but there is strong evidence that changes in arterial stiffness     play a central role. Arterial stiffness as measured by aortic pulse wave velocity (aPWV) and     augmentation index (AIx), is a surrogate marker of cardiovascular organ damage, and is     signiﬁcantly associated with the future risk of clinical events. In addition, aPWV is an     independent and powerful predictor of all-cause and cardiovascular mortality in patients on     dialysis. Reduction of aPWV, mainly by use of an ACE-inhibitor results in an improved     survival in dialysis patients. These findings suggest that arterial stiffness is not merely a     marker of arterial damage but a potentially reversible factor contributing to mortality in     dialysis patients. There is strong evidence that arterial stiffness increases as glomerular     filtration rate (GFR) falls. Conversely, arterial stiffness has also been established in a     number of studies as a significant risk factor for CKD progression.      In addition to arterial stiffness, elevated central aortic blood pressure and central pulse     pressure have been shown to increase the risk of progression of CKD to ESRD. Central blood     pressure is more strongly related than standard BP measured at the brachial arteries     (brachial blood pressure) to concentric left ventricular hypertrophy and carotid artery     hypertrophy as well as to future cardiovascular events.      Cardiovascular disease remains the foremost cause of death post-kidney transplant. Although,     successful kidney transplant has been shown to improve arterial stiffness post-transplant, we     do not know to what extent the pre-transplant arterial stiffness and central aortic blood     pressure and their improvement post-transplant impact the cardiovascular and allograft     outcomes. In addition, it is unclear what transplant related factors are associated with     improvement in arterial stiffness and central aortic blood pressure post-transplant.      The goals of our study are:        1. To determine if pre-transplant central blood pressure and aortic stiffness impact          post-transplant cardiovascular and kidney allograft outcomes.        2. To determine whether the changes in central blood pressure and aortic stiffness          post-transplant impact cardiovascular and kidney allograft outcomes.        3. To determine the factors associated with improved central aortic blood pressure and          arterial stiffness post-transplant.   "
98197|NCT02000856|"     The study is a single center randomised, double-blind, placebo-controlled crossover study to     assess the effects of beetroot juice in patients with pulmonary arterial hypertension.   "
98198|NCT02000843|"     Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to     repair broken eardrums. The Heermann approach is a well recognized procedure, in common     clinical practise for years.      The new approach has been used in patients after informed consent was obtained from each     patient.   "
98298|NCT01999543|"     The study is designed to determine the extent to which a plant-based ingredient on different     food formats affect blood glucose responses in healthy subjects   "
98200|NCT02000817|"     The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of     intravenously administered otelixizumab. In addition, the C-peptide decline in new onset type     1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be     investigated with a view to identifying trends and early immunological biomarkers which could     predict response in halting/slowing Beta-cell destruction in this patient population.      This exploratory study will explore the safety and tolerability between the well tolerated     but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which     efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr     Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the tolerability     dose response is considered a necessary first step to determining the therapeutic index of     otelixizumab.   "
98201|NCT02000804|"     This study is to evaluate pharmacokinetics (PK), pharmacodynamics (PD) and safety of 160 mg     enteric-coated micronised free base darapladib in healthy Chinese subjects.   "
98202|NCT02000791|"     it is compared that laryngeal mask insertion with standard technique and laryngoscopic     technique   "
98203|NCT02000778|"     The overall prevalence of Ovarian Cancer in the United States according to the US SEER     Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the     gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV     it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less     than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age     and decreases with numbers of pregnancies.      The prognosis for many carcinomas is dependent on the extent of surgical resection. At     present, the ability to perform a complete resection with negative margins is limited by the     investigator's ability to palpate and visualize the tumor and its borders. In many cases, a     more radical resection than necessary is performed in order to provide assurance that     negative margins are achieved. This approach may also increase complication rates, as well as     short- and long-term morbidity. It is desirable to improve visualization of primary tumors     and occult metastases in real time, during surgery. The use of fluorescent probes that     recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under     investigation.      Ovarian cancer is a prototypic disease for this type of clinical imaging system called     intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen     and typically involve extensions or implants onto pelvic or abdominal organs or membranes.     Tumor debulking surgery is common early in the disease process as many of the tumors can be     identified by appearance or feel in the skilled surgeon's hands. The major problems are that     tumors can be diffuse and numerous, of various sizes, and often not readily visible in the     surgical field.      Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this     receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist     at the FR-alpha with potential uses for imaging and targeted therapeutic     strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens     examined by immunohistochemistry, so prior treatment is unlikely to affect utility of     FR-alpha agonists as imaging or therapeutic agents.   "
98204|NCT02000765|"     This is an open-label, non-randomized, two-period, cross-over, mass balance study that will     evaluate the recovery, excretion, and pharmacokinetics of a single intravenous (IV) dose of     [14C]-GSK2140944 (Period 1) and a single oral dose of [14C]-GSK2140944 ( Period 2) in 6     healthy male subjects. The results from this study will aid in the design of future clinical     pharmacology studies such as the thorough corrected QT interval study, special population     studies (renal, hepatic, critically ill patients), potential drug interaction studies, and     will help to establish safe and efficacious intravenous and oral dosing regimens.   "
98205|NCT02000752|"     In this study, a single blind randomized trial is carried out in order to compare placental     detachment times when Ren Mai 6 is stimulated and when a different placebo point is used. So,     a lower detachment time is assumed to be related to a higher uterine contraction, and,     therefore, a decrease in the hemorrhage postpartum. We focus on measuring the time it takes     to placental delivery due to the fact that, if this point promotes the uterine contraction,     then the placental delivery will be produced in a short time. Thus, this technique could     decrease the hemorrhage postpartum.      The principal outcome of the study is the placental expulsion time. This time is measured by     the midwife who is responsible of the birth, and it considers the time passed between the     delivery of the newborn and the complete expulsion of the placenta.      Concerning the secondary outcomes, the application of real acupuncture in Ren Mai 6 point,     and sham acupuncture in the placebo point are considered. Their study is derived from the     statistical analysis of the results of the principal outcome. The existence of pain related     to the treatment and the degree of satisfaction of the mother is also a secondary outcome,     analyzed by the survey that the midwife carries out no more than 2 hours after the labor. At     last, it is important to highlight that the degree of satisfaction of the midwife is also     considered as a secondary outcome, since it is registered in the same survey.   "
98257|NCT02000076|"     The main purpose of this study is to investigate the effects of partial sleep deprivation     (PSD) on resting state brain connectivity, emotional contagion, empathy, and emotional     regulation.   "
98206|NCT02000739|"     Genetic mutations associated with cancer are being discovered and new treatments are being     created to treat people whose cancer tumors have certain genetic mutations. Genetic     sequencing of a tumor can be done, and in this study that information is sent to a company     called N-of-One. They will match each patient's tumor's genetic profile to targeted     therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of     FDA-approved drugs, or use of experimental drugs in clinical research studies open at various     locations in the region.      The purpose of the study is to compare the length of time it takes for a tumor to grow in     people who receive the standard treatment for metastatic cancer to the length of time it     takes for a tumor to grow in people who receive a drug specifically targeted for their     cancer's genetic mutation.      Investigators will do a kind of genetic testing called DNA sequencing. Everyone who takes     part in this trial will have genetic testing done on their cancer tumor tissue here at     Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above.      The treatment participants get will depend on the results of the DNA sequencing and the     availability of targeted therapies that match the genetic profile of the tumor identified by     the DNA sequencing.      If there is no genetic mutation that can be identified with current DNA sequencing,     participants will receive the standard treatment for metastatic cancer.      If there is a genetic mutation that can be identified with current DNA sequencing and a drug     has been developed for this mutation, participants may be able to receive that drug. If there     is more than one drug available, the participant and his/her oncologist will decide which is     the best one for the participant.      Because there are many drugs that may be used in this study, the investigator cannot advise     in advance whether or not the drug a participant might receive has been approved by the U.S.     Food and Drug Administration (FDA).   "
98207|NCT02000726|"     Current medical therapies for depression take weeks to achieve full efficacy, and are     ineffective in many patients or cause intolerable side effects, emphasizing the need for a     deeper understanding of depression and its treatment. Identifying early brain biomarkers of     treatments responses seems necessary to improve antidepressant treatment outcome. In this     study we aim to detect early brain responses to a fast acting antidepressant-like treatment     administered intravenously during a Real-Time Neurofeedback functional magnetic resonance     imaging (MRI) Task to predict antidepressant treatment outcome in depression. At completion     of the neuroimaging task, participants will enter a placebo-controlled clinical trial with a     selective serotonin reuptake inhibitor (SSRI).   "
98208|NCT02000713|"     The investigators want to know if magnetic resonance imaging can accurately provide an early     diagnosis of amyotrophic lateral sclerosis (ALS).   "
98565|NCT01996020|"     Transfontanellar Doppler can measure the velocity at both the carotid artery and the anterior     cerebral artery during cardiopulmonary bypass in congenital heart disease patients. This     study can provide reference value of appropriate cerebral blood flow velocity during     pediatric cardiac surgery.   "
98212|NCT02000661|"     Fractional flow reserve (FFR) is a test that can be performed at the time of heart     catheterization. It measures the change in pressure across a narrowing in the heart artery     during high flow situation, and provides reliable information about the functional severity     of the narrowing. FFR measurements accurately predict whether a stent is needed, and is     considered an excellent test before placement of stents to treat narrowed heart arteries.     However, FFR is not used in every case because of the extra time needed and the associated     device costs. Cardiac Services BC (an agency of Provincial Health Services Authority) is     sponsoring this study to find out if FFR should be used in most cases (routine), rather than     the current selective approach.   "
98213|NCT02000648|"     Observation study of patients with chronic rhinitis or chronic urticaria in Thailand   "
98214|NCT02000635|"     The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011     was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence     (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated     with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide range     of symptoms: the most frequent form is a flu-like syndrome but more severe forms are     described as meningitis, uveitis and classical severe presentation such as lung bleedings and     liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of the     disease.      Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic     confirmation during the first week of development and before the appearance of the first     antibody.      If the microagglutination test (MAT) is considered the gold standard test for diagnosis of     leptospirosis. However it requires rending samples to the referent National center for the     leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the     second week of illness. A second sample is required 15 days after the first one, to confirm     the diagnosis.      In clinical practice , the technique of real-time PCR for the detection and quantification of     pathogenic Leptospira during the first week of illness . The technique of diagnosis of     leptospirosis by real-time PCR has been implemented and tested in 2007 at the University     Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of     antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days,     regardless of the severity of the disease. The evolution of leptospiremia treated patients     has not been studied to date.   "
98215|NCT02000622|"     This open label, randomised, controlled, multi-centre phase III study will assess the     efficacy and safety of single agent olaparib vs standard of care based on physician's choice     of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2     mutations.   "
98216|NCT02000609|"     The study aim is to compare the pharmacodynamic effects (cardiovascular effects- primary     variable: Heart rate over 4 hours post dosing- ) after administration of BDP and formoterol     administered as CHF 1535 100/6 NEXThaler DPI or CHF1535 pMDI at two different dose levels.   "
98217|NCT02000596|"     This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in     women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally     advanced and/or metastatic breast carcinoma.   "
98218|NCT02000583|"     The purpose of this study is to learn about the possible benefits of aerobic exercise in     controlling or reducing the amount of amyloid present in the brain, reducing changes in brain     structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in     individuals that have amyloid deposits and are at risk to develop AD.   "
98219|NCT02000570|"     Intraoperative optimization of cardiac output using goal directed fluid challenge is     associated with better outcome. Dynamic preload dependence indicators are well validated     during surgery in supine position. Positioning from supine to sitting position under     anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values     of dynamic preload dependence indicators during surgery in sitting position are unknown. The     objective of this prospective study is to evaluate ability of three dynamic preload     dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and     PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.   "
98220|NCT02000557|"     The present day social setup considers facial charisma as an important physical     characteristic. The facial characteristics of an individual are measured through     anthropometry, photogrammetry, computer imaging and cephalometric radiographs. Cephalometric     radiographs offer significant diagnostic information regarding the association between the     dental and skeletal structures. By means of photogrammetric measurements, a fresh diagnostic     resource is accessible to the orthodontist which permits an intangible, radiation free     attainment of measure points of soft tissue with no instrumental expense and radiation to the     patient.      Orthodontic patients range from adolescents to senior citizens and originate from an     assortment of populations, thus an extensive series of representative norms will be ideal.     Knowledge of the normal dentofacial outline of every group will make certain better success     of treatment to set up the best possible facial agreement. Hence, it is extremely important     to assess the soft tissue profile of a patient as it is one of the most vital components of     orthodontic diagnosis and treatment planning.      The purpose of the present study is to evaluate the photographic characteristics of soft     tissue facial profile of patients with class II malocclusion as ethnic differences have been     found to be reported in the literature. It is hypothesized that soft tissue facial     characteristics on lateral profile photographs and lateral cephalometric radiographs in a     sample of local population with class II malocclusion are closely related.   "
98221|NCT02000544|"     The purpose of this clinical research study is the design of a novel modular hybrid system     extracorporeal circulation circuit for open heart procedures that could easily be converted     from a closed to a semi-closed circuit according to the indication. This could expand the     potential of minimal extracorporeal circulation and could ultimately become the new standard     circuit in performing every type of cardiac surgery.   "
98299|NCT01999530|"     The purpose of this study is to find out whether short term treatment with a antihypertensive     medication prazosin, can influence the levels of a dopamine in the brain. We will examine the     levels of dopamine in the the brain using Positron Emission Tomography (PET) and Magnetic     Resonance Imaging (MRI). We hypothesize that there will be no significant changes in dopamine     levels in healthy individuals taking prazosin.   "
98576|NCT01995877|"     To determine if laying down or standing up changes the diameter of the inferior vena cava.   "
98222|NCT02000531|"     This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin     combination chemotherapy as the first-line treatment for patients with non-small-cell lung     cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.      This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a     second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients     previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease     progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will     be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles     until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).   "
98223|NCT02000518|"     Acute neurological deficit in metastatic spinal cord compression is an emergency condition in     radiation oncology. Despite some reports about the high efficacy of radiation treatment for     oncological emergencies, a standard of care is not well defined, especially the time interval     of immediate RT after deficit, and neurological outcome with respect to poor survival in     non-small cell lung cancer patients. The objective of this trial is to investigate     neurological outcome after emergency radiotherapy in metastatic spinal cord compression of     non-small cell lung cancer patients with acute neurological deficit.   "
98224|NCT02000505|"     Comparison of various methods to improve the quality of CPR   "
98225|NCT02000492|"     Inactivity among schoolchildren is a challenge to public health and for the municipality in     particular. This study´s aim is to evaluate the cognitive and physical as well as social and     fitness adaptations, and learning outcomes of short- and long term ball training for 9-11     years old girls and boys, and to determine to what extend the organisation (5x12 minutes og     3x40 minute a week) and type of training (ball games, circuit training or running) influence     the magnitude of response.   "
98226|NCT02000479|"     The purpose of this study is to investigate the effects of a combined training programme on     insulin resistance, exercise tolerance, muscle strength, body composition and cardiac     function in chronic heart failure patients.      It is assumed that the above mentioned clinical parameters will improve due to physical     exercise.   "
98227|NCT02000466|"     The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy     outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The     Registry requires voluntary, prospective reporting of eligible pregnancies by patients and     health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent during     pregnancy or within 28 days preceding conception, potential confounding factors (such as     exposure to other medications) and information related to the outcome of the pregnancy will     be collected prospectively.   "
98228|NCT02000453|"     This is an open label exploratory study to investigate the safety of 400 milligram (mg )     twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative     colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up     to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6     out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week     2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows     for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the     safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory     tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead     electrocardiogram (ECG), physical examination, and adverse event reporting. These are     standard measurements to evaluate safety.   "
98229|NCT02000440|"     This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate     the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21     subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive     proteinuria as indicated by a Urinary protein/creatinine Up/c ratio >=2 gram/gram (g/g) or 24     hr urine protein >=2 g/day. Losmapimod will be orally administered twice daily over a 24-week     treatment phase followed by a 12-week follow-up for safety and relapse assessments.   "
98231|NCT02000414|"     Peritoneal infection is still a frequent complication in peritoneal dialysis patients . In     France, It contributes to the technique failure, responsible for about 20% of cases of     transfer in hemodialysis. The risk of direct mortality is estimated at 1 to 6% according to     studies. Peritoneal infection is involved in the dysfunction of the peritoneal membrane.      Based on the recommendations of the International Society for Peritoneal Dialysis, the     intraperitoneal route is preferentially recommended. For many antibiotics, pharmacokinetics     (intravenous and intraperitoneal) was studied and protocols for IP administration were     validated.      Daptomycin, is a cyclic lipopeptide natural, active only on Gram-positive bacteria. It is     presented as an alternative to vancomycin in infections resistant pathogens. The stability of     daptomycin in peritoneal dialysis fluids (PDF) has been tested, and antimicrobial activity as     well.      Seven patients were treated with daptomycin intraperitoneally successfully. But no study has     reported pharmacokinetics of daptomycin via the IP route. We propose a pharmacokinetic study     of daptomycin administered intraperitoneally in 12 patients on CAPD and with Gram-positive     peritoneal infection.   "
98232|NCT02000401|"     Intranasal Ketorolac tromethamine has a potential role as a short term pain management tool     for Interstitial Cystitis without the risk and undesirable effects of narcotics.   "
98233|NCT02000388|"     To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine     (SPRIX) as an option for pain management in post vasectomy patients.   "
98267|NCT01999946|"     The purpose of this study is to compare the effectiveness of extended-release naltrexone     (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC     jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort,     which will result in a naturalistic comparison of XR-NTX vs. an established jail-based     methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse     among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among     XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will     compare related opioid treatment outcomes post-release across all arms.   "
98234|NCT02000375|"     A phase II non randomized study evaluating the role of Androgen Receptors as Targets for     therapy of pre-treated postmenopausal patients with ER/PgR-negative/AR-positive or ER and/or     PgR-positive/AR-positive metastatic breast cancer.      Study Design: Multicentric, Open-label not randomized trial.      Description of Study Treatment:      Daily oral administration of DHEA (Dehydroepiandrosterone) at the dosage of 100 mg/die in     combination with a daily oral administration of anastrozole at dosage of 1 mg/die or     letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without     interruption until discontinuation for progression of disease, unacceptable toxicity or     discontinuation/withdrawal of participants from study treatment.      Number of Subjects:      12 patients per group in the first step; if the number of responders is greater or equal to     2, recruitment will continue up to a total of 35 patients (per group).      For the biological part, we will evaluate:        1. Correlation between AR expression and clinical and biological features (tumor size,          nodal status, histotype, grading, proliferative index, ER, PgR, HER2)        2. Evaluation of AR expression on primitive and/or metastatic site in the two distinct          populations of patients: ER/PgR- negative/ARpositive and ER-positive and/or          PgR-positive/AR-positive        3. Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic site (when it is          possible) and comparison with the same features of primitive tumor.        4. CTCs analysis in term of molecular characteristics (gene expression and mutations) and          functionality (vitality and tumorigenicity).        5. Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline          before study treatment and at the moment of discontinuation of treatment.   "
98235|NCT02000362|"     The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with     moderately active Crohn's disease after injection for 28days.      The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of     FURESTEM-CD Inj. which is based on Crohn's disease activity index(CDAI)<150 after injection.   "
98236|NCT02000349|"     The investigators propose to perform a clinical randomized trial to evaluate the effect of a     frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation     rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next     Generation Sequencing (NGS).   "
98237|NCT02000336|"     Although cortisone is widely used in the treatment of patients with early rheumatoid     arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon     starting dosages and placebo in the treatment of patients with early active rheumatoid     arthritis on the background of the established therapy with methotrexate. In total 450     patients will be included into the study. Two different treatment arms starting with 10 or 60     mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In parallel,     all patients start medication with methotrexate, usual dosage 15 mg/week. Primary efficacy     endpoint is progression of radiographic damage after one year compared to baseline. Safety     monitoring is performed.   "
98238|NCT02000323|"     to compare different time points for enteral nutrition in SAP patients   "
98239|NCT02000310|"     The lysosome is a specialized part of the cell that functions to degrade metabolic wastes in     the cell. Defects in the functioning of the lysosome result in accumulation and subsequent     storage of such metabolic wastes. These defects lead to conditions known as lysosomal storage     diseases (LSD). LSDs are caused by inherited genetic mutations and there are over 40     genetically distinct lysosomal storage diseases. Within each specific lysosomal storage     disease there are variances in severity of disease, age of onset, and clinical presentation.     Though the genetic mutations contributing to the disease have been largely clarified, the     molecular and cellular mechanisms that contribute to variations in each distinct LSD remain     unclear. With this study we intend to better understand at the cellular and molecular level     how the accumulation and storage of metabolic wastes in the lysosome affect the clinical     manifestation of LSDs, to detect changes in these mechanisms upon treatment administration,     and to correlate these results to genetic information. The knowledge obtained from this     research study could lead to better ways to diagnose and treat lysosomal storage diseases.   "
98258|NCT02000063|"     A single long-term follow up assessment of an established multi-centre, prospective     longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes     4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.   "
98241|NCT02000284|"     Researchers at Arkansas Children's Hospital Research Institute are conducting a study about     mitochondrial function in children. The study involves 2 visits to Arkansas Children's     Hospital with fasting blood draws and behavioral assessments.      ENROLLMENT IS LIMITED AT THIS TIME TO MITOCHONDRIAL DISEASE AND TYPICALLY DEVELOPING     POPULATIONS      Patients may be eligible to participate if he or she is between the ages of 0‐17 years      And falls into one of the following groups:        -  Is Typically Developing with no known problems OR        -  Has a history of Developmental Delay OR        -  Has been diagnosed with an Autism Spectrum Disorder OR        -  Has a history of a Mitochondrial Disease.      There is no cost for visits or study‐related exams. Participants will receive gift cards as     compensation for their time.      For further information, please contact the program manager, John Slattery, at     jcslattery@uams.edu or 501-364-3556   "
98242|NCT02000271|"     Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little     data to support the practice, purported benefits include reduced pelvic fluid accumulation or     blood loss. Patients often complain of discomfort associated with the packing or its removal.      This randomized controlled trial seeks to document differences in subjective impressions of     pain in women undergoing vaginal repairs treated with and without packing. The investigators     also aim to assess differences in postoperative fluid collection in those with and without     packing.   "
98300|NCT01999517|"     Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography     that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is     used during coronary angiography to see the coronary arteries. It has been shown that     exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some     high risk patients it progresses into renal failure.      This research study offers a new possible option to prevent CIN. We propose that if     intravenous nitroglycerin is given before the procedure it may lower the chances of     developing contrast-induced nephropathy.   "
98243|NCT02000258|"     Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate     ligament (ACL) reconstruction were associated with each other so that MRI-based graft     invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability     of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of     the knee.      Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB)     ACL reconstructions. Two independent examiners made the clinical examinations at the two-year     follow-up: clinical examination of the knee, KT-1000, International Knee Documentation     Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI     evaluations were made by two musculoskeletal radiologists separately and the means of these     measurements were used.   "
98244|NCT02000245|"     The purpose of this study is to evaluate the effect of verbal expression of sympathy and     touch on anxiety of patients undergoing fiberoptic bronchoscopy   "
98245|NCT02000232|"     Measure if FDA regulation of Colchicne in 2009 has resulted in safer use in clinical     settings.      Our study will assess the impact of this Initiative on colchicine use and will provide data     that supports its continuation and expansion.   "
98246|NCT02000219|"     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering     plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.   "
98247|NCT02000206|"     A prospective, randomized, patient-blinded comparison of the safety and efficacy of conscious     sedation by propofol/alfentanil with propofol/ketamine in patients undergoing flexible     fiberoptic bronchoscopy.   "
98248|NCT02000193|"     This is a prospective, single arm phase II study to evaluate the efficacy and safety of     fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal     HR positive advanced breast cancer.   "
98249|NCT02000180|"     It is hypothesized that a progressive simulated learning strategy will result in better     global clinical performance (e.g., technical, communication) and transfer of endoscopic     skill, as compared with a high-fidelity simulation strategy.   "
98250|NCT02000167|"     The purpose of this study is to determine whether a relationship exists between gene     deletion(s) specific to the mitochondrial electron transport chain and presentation of     clinical characteristics in patients with Phelan-McDermid Syndrome (PMS).   "
98251|NCT02000154|"     This is an extension study study to investigate long term safety of SyB L-1101 when     administered intravenously every 4 weeks to the patients who have completed 8 cycles in the     study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered     intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome.     Antitumor effects will also be investigated in this study.   "
98252|NCT02000141|"     To enhance understanding of the risk factors for AMN, improve lesion assessment and     prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce     complications of WF-EMR and improve the understanding of the progression of large lesions to     cancer   "
98253|NCT02000128|"     1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management          versus experiential way on clinical outcome in peritoneal dialysis patients.        2. Design: prospective,randomized,controlled,single center study        3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is          associated with increasing hazard of death and cardiovascular events. Bioimpedance          analysis is a safe, and easy way, which appears to be more useful and sensitive than          other techniques for assessing volume status in dialysis patients. Therefore we          hypothesize that more concise and strict fluid management guided by BIA may help to          improve patients' survival, decrease cardiovascular events and hospitalization rate.        4. Objects: incident and prevalent patients with overhydration status.             1. anticipated cases:240             2. arms: all the patients are randomized into two arms.(BIA group/clinical group)             3. observational time:12 months        5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival,          cardiovascular events, peritonitis, residual renal function.   "
98254|NCT02000115|"     The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical     study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter     Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.   "
98268|NCT01999933|"     The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb)     cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or     concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the     patients received whole pelvis radiation and were divided into three groups according to     adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent     chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant     chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side     effects will be evaluated according to Standard WHO response criteria, and NCI common     toxicity criteria for adverse events(NCI-CTC-AE) V3.0.   "
98269|NCT01999920|"     The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a     receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week     treatment course.   "
98301|NCT01999504|"     The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut     hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along     the lines of the world Health Organisation dietary recommendations   "
98259|NCT02000050|"     Phase II study of up-front chemotherapy and neo-adjuvant shortcourse radiotherapy for     resectable rectal carcinoma.      Study Design: Phase II, open-label, single-arm, multi-centre study.      STUDY PRODUCT,DOSE,ROUTE,REGIMEN AND DURATION OF ADMINISTRATION:        1. Neoadjuvant Treatment (pre-operative chemo-radiotherapy regimen):           FOLFOX4* 2 cycles (WK1+WK3) - Tomotherapy** (WK5) - FOLFOX4* 2 cycles (WK7+WK9)           * Oxaliplatin 85 mg/m2 iv: day 1 Levofolinate 100 mg/m2 iv: day 1-2 5-fluorouracil 400          mg/m2 iv in bolus and 600 mg/m2 iv infusion over 22h: day 1-2 Every cycle will last 2          weeks (approximately 48 hours of treatment infusion and 12 days of rest).           ** 25 Gy in 5 consecutive fractions, one fraction per day in 5 days on CTV (Clinical          Target Volume) at the isodose of the 95% of the total dose. The treatment plan will be          elaborated at the work-station dedicated to the Helicoidal Tomotherapy. The treatment          could be planned also with linear accelerator with IGRT-IMRT technique or VMAT          technique.        2. Restaging (week 11)        3. Surgery (week 12-16) with Total Mesorectal Excision (TME)        4. End Of Treatment (week 16-32)        5. Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy          should be 8 weeks):        6. FOLFOX4* 8 cycles (every 2 weeks)      Study Duration: about 5 years. Enrollment period: 36 months. Treatment period: about 8     months. Follow-up: 1 year.      NUMBER OF SUBJECTs:      · Step A: a maximum of 6 patients. 6 evaluable patients are needed to assess toxicity. If 1     toxicity resulting in discontinuation of treatment will be observed in 6 patients, the     treatment can be considered safe (with a confidence > 90%).      If 2 or more toxicity resulting in discontinuation of treatment on 6 patients, the study will     be stopped because not safe and another type of radiotherapy schedule must be designed.      · Step B: a total of 50 patients is required to be recruited in 2 years (including patients     enrolled in Step A).      The goal is to achieve a proportion of at least 15% of patients with a complete pathological     response with the new radiochemotherapeutic treatment.   "
98260|NCT02000037|"     It is known that the care that is offered to overweigh of class I obese people leads to an     initial weight loss.      However, after 12 months, people start to gain their weight back. French National Authority     for Health suggests that physicians warn their patients against restrictive diets that can     are the origin of weight's fluctuation can be health threatening. This weight regain is     linked to numerous factors, mainly dietary compensation phenomenon tied to cravings (Lecerf,     2013. Obésité : pourquoi les regimes échouent-ils ? Nutr Clin Metab (in press)).      Due to the difficulties to keep the weight loss, it seems interesting to consider     alternatives like reflexotherapy. This method seems to act in reducing the dietary urges     causes by stress, by cravings or by frustration.      This technique would allow to re-establish normal hormones' or neurotransmitters'     concentrations mainly involved in the food intake.      This could be a complementary response to the limits of the classic treatments for weight     maintenance management, but it needs to be confirmed by a specific study.   "
98261|NCT02000024|"     This study is a randomized pilot study to assess the applicability of the Weight Watchers     model for lifestyle modification to the primary prevention of type 2 diabetes. The approach     developed by Weight Watchers to achieve weight loss is based on similar nutritional     principals and techniques used in the Diabetes Prevention Program (DPP) lifestyle     intervention; monitoring food intake, exercising calorie control, setting modest weight loss     goals and using physical activity.   "
98262|NCT02000011|"     The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic,     hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical     resection. For patients aged of 70 years old and more, this surgery is associated to an     increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive     geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be     complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old     patient population without cancer, CGA associated with a geriatric intervention plan (GIP)     allows autonomy preservation, decrease of institution admission, and survival improvement.     The reference study showed that a CGA associated to a GIP improves survival of old patients     who had a cancer surgery. However this study included patients from 60 years old and the GIP     consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.      We propose to perform a prospective and randomized study to evaluate the impact of a CGA with     GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer     resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8     distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status,     depression, cognitive function and social status. The impact of such a strategy on autonomy     and survival has never been studied.   "
98263|NCT01999998|"     Chemotherapy followed by radiotherapy is used to treat early stage lymphomas with excellent     cure rates. However, a significant proportion of these patients develop cancers and heart     diseases years later as a result of the radiotherapy. Therefore, there is a move to reduce     radiation exposure without compromising cure rates. Radiotherapy is planned using a CT scan     taken following chemotherapy when many of the original sites of the lymphoma are no longer     visible using a CT scan taken following chemotherapy when many of the original sites of the     lymphoma are no longer visible.      In order to safely minimise the volume treated with radiotherapy it is necessary to     accurately reconstruct the extent of the lymphoma prior to chemotherapy on this 'planning' CT     scan. A PETCT prior to chemotherapy is the best way of demonstrating the original extent of     the lymphoma, but is taken in a different position to the radiotherapy treatment position.     This aim of this study is to explore whether a PETCT scan taken prior to chemotherapy in the     radiotherapy treatment position, in conjunction with advanced software to combine this scan     with the subsequent radiotherapy planning CT, can be used to more accurately identify the     lymphoma target. The study aims to recruit up to 20 patients with early stage Hodgkin     lymphoma or high grade nonHodgkin lymphoma. A routine staging PETCT will be followed at the     same session by a PETCT in the radiotherapy treatment position appropriate radiotherapy     immobilisation devices. Participation in the study will not affect treatment decisions or the     radiotherapy planning process. The PETCT in the radiotherapy planning position will be made     available to the treating clinicians. The process of planning radiotherapy will not be     systematically altered by the study. The study is aimed at determining how to improve the     radiotherapy planning process in the future, in the hope of a reducing in the long term side     effects of treatment whilst retaining high cure rates.   "
100215|NCT01974401|"     in this study , effectiveness of supragingival irrigators containing chlorhexidine is     compared with routine oral health measures in patients with blood dyscrasia whom can not use     effective oral health measures(e.g brushing ) due to their systemic condition(e,g,neutropenia     ,thrombocytopenia,..)   "
98264|NCT01999985|"     The purpose of this study is to:        -  Find out if the study drugs Afatinib and Dasatinib can be safely given together to          patients with lung cancer        -  Learn how these two drugs work in cancer cells when they are combined        -  Learn more about the side effects of these two drugs when combined        -  Find the highest doses of the study drugs Afatinib and Dasatinib that can be given          safely without causing serious side effects   "
98265|NCT01999972|"     Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of     patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment,     while the majority of patients will eventually develop evasive resistance. It is proposed     that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor     (HGF or scatter factor) contribute to VEGF inhibitor resistance, such that combining a c-MET     inhibitor with a VEGF inhibitor will provide additional clinical activity compared to VEGF     inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in     combination with the VEGF inhibitor, axitinib.Since this will be the first study of axitinib     given in combination with crizotinib, the study will primarily assess the safety and     tolerability of the combination regimen.   "
98266|NCT01999959|"     To demonstrate a possible beneficial impact of pertubation we designed a randomized     prospective study, in which uterine washing was administered prior to insemination in     patients diagnosed with unexplained infertility.   "
98270|NCT01999907|"     Viral infections are the main cause of asthma attacks in preschoolers, an age group with the     highest rate of emergency visits due to asthma. While high doses of inhaled or oral     corticosteroids provide benefits, these have been associated with adverse outcomes. Most     asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children.     Low vitamin D level has been linked to more frequent and more severe asthma attacks as well     as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D     supplements can reduce the number of asthma attacks triggered by viral infections in     children. Unfortunately, most people forget to take vitamin D every day during the fall and     winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth.     This has been shown to safely and effectively increase vitamin D levels in children. The     investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase     the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared     with placebo in preschool-aged children with asthma. This six-month pilot randomized     controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising     vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled     participants; and (3) identify problems that may call for protocol changes.   "
98271|NCT01999894|"     The purpose of this study is to evaluate the long-term safety and tolerability of memantine     in the treatment of autism in pediatric patients.   "
98272|NCT01999881|"     This randomized pilot clinical trial studies exercise intervention in improving quality of     life and exercise capacity and reducing inflammation and oxidative stress in patients with     lung cancer and their support persons. Exercise therapy may help improve quality of life, may     increase exercise capacity, and may reduce inflammation and oxidative stress in patients with     lung cancer and their supporters.   "
98273|NCT01999868|"     The purpose of this study is to determine if the use of ustekinumab, followed by abatacept,     will prevent relapse in people with moderate to severe plaque psoriasis.   "
98274|NCT01999855|"     For many years, it is known that asthmatics have more often dysphonia. However, no study has     so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.      The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time,     inhaled corticosteroids have been considered as responsible for organic abnormalities of the     vocal cords. We hypothesized that women with asthma have more often dysphonia, and that     dysphonia is rather functional origin.   "
98275|NCT01999842|"     The purpose of this study is to evaluate the safety and immunogenicity of different     formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.   "
98276|NCT01999829|"     Atrial fibrillation remains a major cause of morbidity following cardiac surgery with     cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong     endogenous vasodilating agent has been involved in cardiac surgery-induced atrial     fibrillation, via A2A receptors modulation.      The effects of caffeine on the inducibility of atrial fibrillation are actually well-known,     leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical     study has demonstrated that coffee drinking was inversely associated with total and     cause-specific mortality.      The investigators therefore examined the preventive effects of oral caffeine on valvular     surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also     evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A     adenosine receptors modulation.   "
98277|NCT01999816|"     The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign     intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and     associated surgeries in adults with spinal cord injury, and (2)assess the intervention's     cost-effectiveness and potential cost savings and its effects on participants' quality of     life.   "
98278|NCT01999803|"     This is a phase I, multicentre randomised, double-blind, placebo-controlled trial to assess     the safety and tolerability of continuous i.c.v. administration of sNN0029 infusion solution     at a dose of 4µg/day in patients with Amyotrophic Lateral Sclerosis (ALS).   "
98292|NCT01999621|"     Investigators will evaluate determinants of the patients' care type : palliative, medical or     intensive care. The place of patient or family on care's decision will be noticed.     Investigators will evaluate 3 month-survival and patients' feelings (visit with a     psychologist) according to type of care they benefited.   "
98360|NCT01998711|"     Aims:      To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive     impairment, assisted by family members or friends. To equip persons with mild cognitive     impairment with specific skills to prevent memory failures and improve the capacity of     patients and families to cope with everyday memory difficulties.   "
98361|NCT01998698|"     The investigators would like to assess whether monovision correction of multifocal lens     insertion provides more satisfaction to cataract patients following an uncomplicated     phacoemulsification surgery.   "
98279|NCT01999790|"     Grave's ophthalmopathy is the most common cause of orbital disease in adults. The clinical     presentation may vary between sub clinic symptoms to severe ones. The eyelid retraction is     one of the most important signs of Grave's ophthalmopathy and can lead to cosmetic and     functional problems.      The eyelid retraction can be found in the inflammatory stage and in the chronic disease, when     it is stable. It can be described when the upper lid is contouring the superior limbus or     positioned above that. This condition can lead to dry eye symptoms, exposure keratitis and     cosmetic issues. The treatment can may be surgical or medical.      The medical treatment are usually based on controlling thyroid function and in the use of     steroids, both are not specific for the lid retraction, but for the inflammation that is     common in the disease.      In the longstanding disease, surgery is the most efficient treatment. There are several     described techniques, they are based on the concept of weakening the muscles that act on lid     elevation (levator and Muller Muscle).      Basically the techniques can be divided in two groups: the first with an anterior approach     (with skin scar in the lid sulcus) and the second using a posterior approach (through the     conjunctiva).      In the literature there is no consensus in deciding the best technique, regarding cosmetic     results, incidence of complications, hypo or hypercorrection.      In this trial we propose to compare two distinct techniques that are already in clinical use.     The blepharotomy uses a cutaneous approach and the other a conjunctival approach.      The patients will be divided in two randomized groups and surgical expected outcomes,     cosmetics outcomes and complications occurrence will be compared.   "
98280|NCT01999777|"     This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared     with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased     seizure activity.   "
98281|NCT01999764|"     This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on     adults with impaired dark adaptation.   "
98295|NCT01999582|"     To determine the optimal route of administration, dose level, and safety of intravenous and     subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on     hemodialysis.   "
98390|NCT01998321|"     the Purpose of this study was to evaluate the short term outcome of patient specific     instrument (PSI) in cases of bilateral simultaneous total knee arthroplasty (TKA) for knee     osteoarthritis with sever varus   "
98283|NCT01999738|"     Phase 1A/B, multicenter, open-label, non-randomized, dose-escalation oncology study to     evaluate the administration of EC1456 in advanced solid tumors. In part A, EC1456 will be     dose escalated on 4 concurrently enrolling schedules. FR-positive expression on a     99mTc-etarfolatide scan is not required for inclusion in Part A.      Part B of the study will confirm the maximum tolerated dose (MTD) and the recommended Phase 2     (RP2) dose of EC1456, and evaluate the efficacy of EC1456 in NSCLC all subtype patient     populations with FR-positive cancer in up to three schedules (i.e., twice weekly, once     weekly, and four times weekly). FR-positive expression on a 99mTc-etarfolatide scan is     required for inclusion in Part B.      Minimum length of patient participation is anticipated to be 10 weeks (two 3-week cycles     followed by a 30 day follow-up period).   "
98284|NCT01999725|"     The primary objective of the study is to determine the safety of single doses of orally     administered EDP-788.      Secondary objectives of the study are:        -  To describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after single          doses of orally administered drug        -  To estimate the bioavailability of EDP-788 capsules relative to an oral liquid          suspension        -  To estimate the effect of co-administration of food on the absorption of EDP-788   "
98285|NCT01999712|"     The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left     side of the heart of patients with severe heart failure that are awaiting heart     transplantation or are not transplant candidates. However, while LVAD supports the left side     of the heart, the right side must work on its own. Sometimes the right side does not recover,     a condition called right ventricular failure (RVF). This complication increases mortality,     prolongs hospitalization, requires additional procedures, and increases costs. Several risk     factors and scores have been proposed to identify patients at risk for RVF. However, these     methods have proven inadequate; one out of three patients is still experiencing right     ventricular failure after LVAD surgery.      Echocardiography, an established noninvasive method to see the heart without radiation or     risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray     to answer with this American Heart Association funded project are:        1. Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF          and poor quality of life so we can better select patients for LVAD surgery?        2. Can echocardiography before scheduled LVAD surgery tell us the course of right          ventricular function after implantation so we can potentially take additional measures          and prevent RVF?      To answer these questions, we will record images of the heart with echocardiography before     LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for     90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record     the course of right ventricular function with echocardiography.      Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD     recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of     life in suitable patients. However, implantation requires a major surgical procedure with     associated risks and considerable resources. Thus, careful patient selection is necessary to     minimize risk for patients and maximize benefit for patients and society. Our long-term goal     is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer     alternatives to patients at increased risk for complications and (2) potentially, inform     earlier LVAD implantation in patients with weakening right ventricular function.   "
98286|NCT01999699|"     This study will investigate the response of the immune system to a hepatitis B (HB) vaccine     in healthy adults 50 to 70 years of age. This study is partially funded by the National     Institute of Allergy and Infectious Diseases.   "
98287|NCT01999686|"     This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6     months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of     DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive     parameters.   "
98288|NCT01999673|"     The primary purpose of this research study is to see whether adding bavituximab (an     investigational drug) to the standard chemotherapy drug docetaxel, will improve the results     of the treatment for non-small-cell lung cancer.   "
98289|NCT01999660|"     A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation     therapy in prostate cancer patients   "
98290|NCT01999647|"     This study was designed to assess whether the injection of local anesthetic into the nerve     (intraneural), as opposed to around it (perineural), requires a shorter time to develop     surgical anesthesia of the lower leg.      The investigators will compare the two types of injection using the same drug, so as to     determine if there is an actual difference onset time. They will also examine the overall     success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent     orthopedic surgery.      The safety of these procedures will be examined by in-hospital and phone-call follow-up     contacts.   "
98291|NCT01999634|"     The aim of this study is to monitor by microdialysis the postoperative outcomes in order to     identify anastomotic leaks after rectal surgery.   "
98293|NCT01999608|"     The role of vitamin D deficiency in female reproduction remains controversial. Early     retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels     on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two     retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy     rates with an effect mediated through the endometrium.      Taking into account that knock-out experiments have shown that vitamin D receptor null mice     not only experience uterine hypoplasia but also impaired folliculogenesis, it might be     hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian     reserve. This may be further supported by previous reports demonstrating that serum 25-OH     Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced     reproductive age.      The aim of this study is to examine through a large set of prospectively recruited infertile     women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted     biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).   "
98294|NCT01999595|"     The purpose of this study is to determine the antalgic of surface electrical stimulation with     pulse frequencies and pad sizes on blunting pressure pain on healthy human due to various     temporal and spatial summations of the stimulation.   "
98302|NCT01999478|"     The study is testing a new, safe and effective way for the early detection of colon cancer.     The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS). This is an optic     probe which is a small device that uses light (not laser) to assess the colon lining. This     probe will be used before colonoscopy to identify subjects who do and do not have     precancerous changes in the colon by capturing the light reflected back from the rectal wall     and that will be assessed without the need for colonoscopy and bowel preparation (colon     cleaning). This device may detect early cancerous changes in colon tissue with higher     accuracy than current tests.   "
98303|NCT01999465|"     Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the     affected arm, results from damage in the prenatal period to the nerves extending from the     spine to the arm. Proper stretching and exercise of the joints and affected arm from the time     of diagnosis can greatly assist in the development of healthy movement of the limb.     Additionally, neuromuscular electrical stimulation has been shown to be an effective     treatment in other neural disorders and therefore its effectiveness in NBPP is worth     studying.      In the case of NBPP patients, the loss in normal arm function can be observed very early.     Young patients will often neglect using the affected arm or modify motions to avoid the use     of the biceps muscle, specifically in hand to mouth actions such as gripping a bottle or     placing toys or other objects in the mouth. A goal of this study is to test the effectiveness     of NMES on the biceps muscle in improving the participant's ability to perform normal hand to     mouth actions. Additionally, biceps muscle Medical Research Council (MRC) strength and active     range of motion (AROM) will be tested to examine the increase of useful arm movement.      The subjects of this study are newborns between the ages of 3-6 months who are already a part     of the University of Michigan Brachial Plexus program. Parents of the children will be     trained to perform the neuromuscular electrical stimulation therapy at home using the EMPI     Continuum unit for 30 minutes each day and monthly follow up appointments will be performed     be the research occupational therapists throughout three month study period.      Parents of the participants will complete a questionnaire before and during the study period     to help analyze for confounders and gather data regarding parent compliance and NMES     effectiveness. To detect the effectiveness of NMES, two cohort groups using standard units     and sham units will be recruited and compare with data analysis.      The investigators predict that the NMES will effectively improve the ability of the neonate     to increase use of the affected arm, specifically in hand to mouth movements and other     aspects of biceps MRC score and AROM.   "
98304|NCT01999452|"     Background Paleolithic diet is a modern dietary regimen based on food eaten during the     Paleolithic (2.5 million-10.000 years before present); lean meats, fish, shellfish, fruits,     vegetables, root vegetables, eggs and nuts. Food that was not eaten during the Paleolithic is     avoided; cereals, dairy products, salt, refined sugar and fat. The rationale for Paleolithic     diet is based on the lack of type 2 diabetes and associated diseases among hunter-gatherer     populations. Our group have previously studied effects of Paleolithic diet in an     observational study in humans, an intervention study in animals and two intervention studies     in patients with type 2 diabetes or lowered glucose tolerance and ischaemic heart disease.     Our intervention studies showed significant improvement of glucose tolerance, HbA1c, blood     lipids, blood pressure, weight, waist circumference and satiety on Paleolithic diet compared     with a Mediterranean-type diet and diabetes diet. Studies by other research groups on healthy     individuals found that Paleolithic diet lowered weight, waist circumference, blood pressure,     PAI-1, blood lipids and ectopic lipid deposition, and also improved glucose tolerance and     insulin sensitivity.      Purpose and aims Our goal is to study effects of Paleolithic diet compared to recommended     diet on risk factors, morbidity and mortality from type 2 diabetes and associated diseases in     a sufficiently large and well executed study to be included in basis for future dietary     recommendations.      Project descriptions SwePaD is a study with an initial 18 month long randomized cross-over     dietary intervention on 150 patients with type 2 diabetes where the whole study population     upon finishing the initial dietary intervention is studied as a cohort for another 5 years.     The initial 18 month long dietary intervention compares 6 months on Paleolithic diet with 6     months on recommended diabetes diet separated by 6 months wash-out period. After the initial     18 month long dietary intervention the study participants are recommended to follow     recommended diabetes diet with implementation of optional elements from a Paleolithic diet     for the remaining 5 years of the study.      The intervention, in the form of diet information, will be given orally and written by the     study participant's own diabetes nurse or doctor, based on similarly designed written     information on the two diets. The same intervention was successfully used in our pilot study.     The study participants will otherwise receive usual treatment.      Power calculations show that 126 participants are needed to obtain significant results with     80% power at the 95% significance level for the primary outcome HbA1c. The pilot study with     the same intervention but slightly healthier participants than the average patient in     Diabetesregistret showed significant results on HbA1C with only 13 participants.      Secondary outcomes are fasting glucose levels, weight, waist circumference, blood pressure,     blood lipids, urinary albumin, diabetes retinopathy, smoking, physical activity,     monofilaments (detection of peripheral neuropathy) and health related quality of life     assessed by the health survey questionnaire SF-36. Primary and secondary outcomes as well as     medication will be registered before and after each intervention diet. Data on primary and     secondary outcomes, morbidity and mortality from type 2 diabetes and associated diseases will     be retrieved for up to five years after participants' completion of the dietary intervention     from the Diabetes register, Cause of Death Register (Dödsorsaksregistret) and the Hospital     Discharge Register (Patientregistret) and compared to expected outcome from a statistical     model based on the Diabetes register (A new model for 5-year risk of cardiovascular disease     Cederholm et al 2011) and/or a matched control group from the Diabetes register.      Participants will be recruited nationwide through information to health care personnel in     primary health care and hospital diabetes clinics and to patient organisations. Participants'     registration, intervention and data gathering will be administered by the participants' own     diabetes nurse or doctor via REDCap, a web based tool for secure electronic data capture     hosted on secure servers with daily back-up by the Library and IKT department of the medical     faculty at Lund University.      Dietary evaluation will be made using four day weighed food records on paperforms before and     after each intervention diet and 6 months after the last intervention.   "
98305|NCT01999439|"     To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive,     radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and     stiffness) and response to treatment in children and adolescents with newly diagnosed     eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food     impaction.   "
98306|NCT01999426|"     Emergency on-call respiratory physiotherapy cover for children in intensive care is     frequently provided by physiotherapists who ordinarily work in non-respiratory areas. This     has produced concerns about the safety and efficacy of on-call treatments and is widely     recognised as an important clinical governance issue affecting services throughout the     National Health Service (NHS).      The aim of this study is to investigate whether emergency on-call respiratory physiotherapy     services provided in the paediatric intensive care unit (ICU) are safe and effective. Further     it will explore whether there are any quantifiable differences between specialist and on-call     physiotherapy treatments.      The study is a randomised, cross-over study design. Infants and children who are likely to     require at least 2 physiotherapy treatments in one day are recruited to the study. Both     physiotherapy airway clearance treatments are administered during a 12 hour period, with at     least 2 hours between treatments. One is administered by a respiratory physiotherapist who     works regularly in the ICU and one by a physiotherapist on the on-call rota, who normally     practises in a non-respiratory clinical area. Treatments are performed in a randomised order     and outcomes measured before, during and after treatments.      Physiotherapy staff who consent to participate in the study include:      Specialist respiratory physiotherapists who regularly work in the ICU Non-respiratory     physiotherapists on the on-call rota who normally work in a non-respiratory areas but cover     the ICU overnight and at weekends.      Patients include:      the study aims to recruit 80 infants and children (ages 0 to 16 years), who are in the     paediatric intensive care unit and        1. Require full mechanical ventilation and are well sedated        2. Are likely to require at least two physiotherapy treatments within the day of the study          (assessed by an independent senior respiratory physiotherapist) and        3. Whose parents or carers consent for them to participate in the study. Respiratory          mechanics, arterial blood gases, oxygen saturation and peak pressures are recorded          before and after each intervention Forces applied during manual techniques, flow,          pressure and volume during manual lung inflations, volume of saline and selection and          order of treatment components are recorded during treatments Adverse events occurring          during or up to 30 minutes after physiotherapy are also recorded.   "
98307|NCT01999413|"     Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to     daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of     Younger patients (under 61 years) with high-risk cytogenetics.   "
98308|NCT01999400|"     This study is designed to provide data to the FDA correlating pharmacokinetics with local     availability of medications within the gastrointestinal tract. This study will support the     establishment of scientifically based standards for evaluating drugs which act locally within     the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the     plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are     correlated with the concentrations in gastrointestinal fluids; and (2) improve the     physiologically based models for drug absorption from the intestine. Information from this     study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro     correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of     mesalamine products.   "
98309|NCT01999387|"     Food allergy is a potentially life threatening condition. The current practice consists of     elimination diet and injectable epinephrine in case of a reaction.      Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and     peanuts.      We conduct an oral immunotherapy program with ~500 patients so far. In this study we intent     to follow patients who completed the program and assess their allergy status and quality of     life.   "
98329|NCT01999114|"     The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr     buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo     in healthy male and female subjects.   "
98310|NCT01999374|"     Since its inception, the Diabetes Research Institute (DRI) has made significant contributions     to the field of diabetes, pioneering many of the techniques used in diabetes centers around     the world. Through several clinical trials, DRI has demonstrated that diabetes can be     successfully reversed as a result of islet cell transplant.      Over the years the following protocols in islet cell transplantation have been initiated:     2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210.      All of the studies listed above will be source of study subjects for this study.     Approximately 30 subjects are expected to be enrolled and followed in this trial.      After islet-cell transplantation in the parent studies, each subject receives maintenance     immunosuppressive medications.      The purpose of this protocol is to collect additional follow-up for safety and efficacy from     subjects with graft function after their completion in their parent study. It is expected     that most subjects will retain measurable islet function and, in the islet-alone studies,     continue to receive immunosuppressive medications at the time of completing their parent     study.   "
98311|NCT01999361|"     This is a single-center, prospective, open label study in islet transplant recipients after     complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.   "
98312|NCT01999348|"     The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD     (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in     accordance with physician standard clinical practice. All treatment decisions lie with the     physician.   "
98313|NCT01999335|"     The purpose of Phase 1 of the study is to determine the maximum tolerated dose and assess the     safety, tolerability and activity of oprozomib in combination with pomalidomide and     dexamethasone in subjects with primary refractory or relapsed and refractory multiple     myeloma.      The purpose of Phase 3 of the study is to compare the key outcome measures for subjects with     primary refractory or relapsed and refractory multiple myeloma who are randomized to either     oprozomib or placebo in combination with pomalidomide and dexamethasone.   "
98314|NCT01999322|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and     insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII)     system in adult subjects with type 1 diabetes.   "
98315|NCT01999309|"     Rationale: There is ample evidence that inflammatory processes play a role in the     pathophysiology of schizophrenia. Although Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)     have been shown to be able to reduce symptoms in these patients, these drugs either have     unfavourable cardiovascular side effects or are otherwise not well tolerated. Moreover,     patients with schizophrenia already tend to have an increased cardiovascular risk. The     combination of well-established vascular protection and reduction of inflammation by     simvastatin offers a highly attractive potential to further improve the treatment of     schizophrenia and related disorders.      Hypotheses: Daily treatment with 40mg simvastatin in addition to antipsychotic treatment     reduces psychotic symptoms, improves cognition, attenuates brain volume loss, and decreases     the risk for metabolic syndrome as well as for movement disorders, when compared to placebo.      Objective: The primary objective of this trial is to investigate the proposed beneficial     effect of simvastatin as compared to placebo when given for one year in addition to     antipsychotic medication to patients with psychotic disorder. We expect lower symptom     severity as measured with the PANSS (Positive and Negative Syndrome Scale) and less cognitive     decline as measured with the BACS (Brief Assessment of Cognition in Schizophrenia).Secondary     objectives are assessment of general functioning, presence and severity of metabolic syndrome     and degree of movement disorders, and assessments of brain volume. Lastly, we examine various     immunological parameters in serum and peripheral blood mononuclear cells and the experience     of childhood trauma.      Study design: Randomized placebo-controlled double-blind trial.      Study population: 250 men and women, between 18 and 50 years of age, diagnosed with     schizophrenia, schizoaffective or schizophreniform disorder (DSM-IV 295.*) or psychosis NOS     (not otherwise specified) (298.9). Onset of first psychosis no longer than 3 years ago.      Intervention: Patients will be randomized 1:1 to either 40 mg simvastatin or placebo daily,     in the form of identical tablets.   "
98316|NCT01999296|"     All patients undergoing laparoscopic visceral and gynecologic procedures using the combined     bipolar and ultrasonic vessel sealing and dissection device Thunderbeat are entered in a     prospective registry. Data will be analysed concerning the safe use of the instrument and     perioperative blood loss.   "
98317|NCT01999283|"     Exercise has been found to be effective in alleviating back and neck pain. Two exercise     methods which are available in the community in a group format are Yoga and Pilates. While     there is some research on the efficacy of these exercise methods for low back pain, there is     no definitive research on the use of Yoga or Pilates group exercise for individuals with     chronic cervical pain.This study investigated the effect of group Yoga and Pilates exercise     compared to a wait-listed control group on impairments and function related to neck pain for     individuals with chronic cervical pain.   "
98318|NCT01999270|"     To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.   "
98319|NCT01999257|"     The investigators have developed a new website to educate persons of Ashkenazi Jewish     ancestry about their increased risk for having children with certain genetic conditions, and     the genetic testing the investigators offer. This study aims to pilot the website to find out     whether it is effective and to learn what the investigators can improve.      Participants in the study will be assigned to one of two conditions:        1. Standard in-person genetic counselling session to learn about inheritance of Ashkenazi          Jewish genetic conditions and genetic testing. Participants will fill out two short          questionnaires, one before and one after the genetic counselling session. They will then          be given a requisition form to undergo blood draw for genetic testing at the Montreal          General Hospital test centre.        2. Use of a web-based pre-test genetic counselling tool to learn about inheritance of          Ashkenazi Jewish genetic conditions and genetic testing. They will fill out two short          questionnaires, one before, and one after using the web-based tool. They will then be          electronically sent a requisition form to undergo blood draw for genetic testing at the          Montreal General Hospital test centre.      In both conditions, genetic test results will be communicated by telephone once they are     available. Participants' genetic test results will not be used in any way for the study.   "
98330|NCT01999101|"     The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD     patients and to assess the influence of Px-104 on hepatic fat.   "
98362|NCT01998685|"     This study aims to assess if different anesthetic techniques can affect coagulant factors in     patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).   "
98363|NCT01998672|"     The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102     in healthy subjects after 7 days multiple oral dosing.   "
98320|NCT01999244|"     Despite continued research on effective interventions, obesity remains a major public health     issue in the United States. Current treatments, including behavioral weight management     programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited     reach, reducing the ability of these treatments to address the population-wide scope of the     obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and     provide targeted feedback offer promise to help larger groups of individuals to lose weight.     Despite the commercial popularity of these products, however, little research has been     conducted to evaluate their impact on excess body weight or to determine how they should     ideally be implemented. Two key questions need to be addressed. First, is use of     self-monitoring technology sufficient to produce weight loss, or must this technology be     combined with interventionist contact? Second, how cost-effective is a technology-based     intervention, with and without interventionist contact? The current study is small     prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to     a technology only condition (TECH) and a technology plus interventionist support condition     (TECH+INT). All participants will all be given basic weight management information knowledge     and randomized to one of three conditions. Participants in the self-guided self-monitoring     condition (SC) will receive traditional paper self-monitoring logs, a standard body weight     scale, and a pedometer and calorie book; participants in the technology-based condition     (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and     will track caloric intake via an associated website; and participants in the interventionist     contact condition (TECH+INT) will receive the same technology as in the TECH condition,     combined with weekly interventionist contact delivered via telephone. We will compare the     impact of each condition on weight loss and investigate preliminary cost-effectiveness.   "
98321|NCT01999231|"     In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis     Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.      24 healthy adults were included as study objects, they were randomly divided into four groups     of different Recombinant Allergen EC dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6     person/dose) for single arm intradermal injection.      The main examination items :vital signs (breathing, heart rate, blood pressure, body     temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after     injection, skin reactivity (redness and/or induration) diameter of injection sites,local     reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse     events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films     before and 7 days after intradermal injection .      Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in     humans, which can provide a safe dosage range for phase II clinical study.   "
98322|NCT01999218|"     This study will evaluate the efficacy and safety of the addition of ertugliflozin     (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who     have inadequate glycemic control on metformin. The duration of the trial will be up to     approximately 122 weeks. This will include a 1-week screening period, an up to 13-week     wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week     double-blind, active comparator-controlled treatment period, and a post-treatment telephone     contact 14 days after the last dose of study drug. The primary hypothesis of this study is     that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated     with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in     participants treated with the addition of glimepiride.   "
98323|NCT01999205|"     The participants are twelve small or middle-sized companies. Baseline information about the     company's practices and employees' physical activity is collected in November 2013 with     questionnaires and accelerometers. A team is nominated in each company to develop company's     practices in relation to promoting physical activity and reducing sedentary behavior among     employees. The teams are supported with materials and meetings and the opportunity to obtain     physical activity services from the regional offices of the Finnish Sports Confederation. The     development process is carried out in Fall 2013 and the actions to promote physical activity     and to reduce sedentary behavior are implemented in the companies during spring and fall     2014. The follow-up evaluation with the same measures as at baseline will be conducted in     November 2014 and depending on financing possibly also in November to assess the maintenance     of the actions.   "
98324|NCT01999192|"     The purpose of this study is to determine the efficacy and safety of three different     Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active     rheumatoid arthritis and an inadequate response to MTX alone.      The overall study duration is 24 weeks followed by a 24 week extension phase.   "
98325|NCT01999179|"     The goal of the pilot study is to determine if a multicenter prospective cohort study of     cancer patients with blood clots associated with catheters is feasible. Cancer patients with     catheter-related thrombosis treated with one month of anticoagulation will be evaluated for     for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of     recurrent thrombosis.   "
98326|NCT01999166|"     This study will investigate the genes responsible for osteoarthritis. Individuals with     osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible     for this study. Family members may also participate.      Patients will talk with investigators who will explain the study and its possible     implications for the patient and family and answer questions. The patient's medical records     will be reviewed, a personal and family history will be taken, and a physical examination     will be done. Two procedures may be done including blood sampling (which will be used for DNA     (genetic) studies) and X-rays (to define osteoarthritis grade).      If no known mutations responsible for osteoarthritis will be detected, participating family     members will be interviewed by telephone about their personal and family health history and     will have a blood sample drawn for DNA testing, and X-rays.   "
98327|NCT01999153|"     The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at     the thin skin graft donor site.      For Patient needing a thin skin graft < 320 cm2, randomization will be done in 2 groups, one     receiving the standard treatment (20 mL of physiologic serum) during the surgical     intervention in topical use to recover an alginate dressing (Algosteril)and the other receive     20 mL of Naropein during the surgical intervention on alginate dressing.      The hypothesis of the study is the administration of ropivacaine will decrease the     post-operative pain compared to physiologic serum   "
98328|NCT01999140|"     The ICD Registry™ is a nationwide quality program that helps participating hospitals measure     and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and     cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry     captures the characteristics, treatments, and outcomes of patients receiving (ICDs).     Patient-level data is submitted by participating hospitals on a quarterly basis to the     American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry     (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to both     a volume peer group (number of ICD patients submitted annually) and the entire ICD registry     data set.   "
98331|NCT01999088|"     Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods:     intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated     by a 4 weeks wash-out interval during which subjects returned to their usual diet:      During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM)     products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and     meat derivatives had to be excluded from the diet.      During the C period, volunteers consumed identical amounts of meat products that did not     include functional ingredients (Control Meat (CM)).      Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey breast     (FT)), were manufactured mixing the meats with the patented formula® (P200402755.2004). The     amount of supercritical rosemary extract, deodorized salmon oil and vitamin E used was     respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.      Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were     prepared without addition of the functional ingredients.   "
98332|NCT01999075|"     Duchenne Muscular Dystrophy is complicated by weak breathing muscles and lung infections.     Lung volume recruitment is a technique performed using a face mask or mouthpiece and a     hand-held resuscitation bag to stack breaths, inflate the lungs and help clear the airways of     secretions by increasing the forcefulness of a cough. We believe this will slow down the     steady loss of lung function, prevent lung infection, and improve quality of life. Our aim is     to compare the outcome of a group of individuals with DMD treated with standard care to     another group that also receives lung volume recruitment. If effective, this study will     change clinical practice by including twice-daily treatment as part of the standard of care     for individuals with DMD, in order to improve their lung health and quality of life.   "
98333|NCT01999062|"     In the proposed research study, we are investigating the feasibility of integrating automated     planning tools to MR images acquired using a novel MR-guided linac, for on-line adaptive     radiation treatment. However, these on-line automation tools require further technical     refinement and clinical validation. The goal of this research proposal is to develop an     on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an     approach will provide early stage breast cancer patients timely access to high-quality     adaptive treatments without exposure to additional ionizing radiation.   "
98334|NCT01999049|"     The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients     who are blind from retinal degeneration - retinitis pigmentosa. These patients have no     alternatives. Patients typically can achieve ambulatory vision.   "
98335|NCT01999036|"     Evaluation of the impact of bystander CPR, prehospital resuscitation protocols, and hospital     post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of     Arizona.   "
98336|NCT01999023|"     Chronic renal disease is now the tenth leading cause of mortality Taiwan. It is worth to     study the effect of low protein formula on the retardation of failing renal function,     decrease plasma homocysteine and oxidative stress and further increase antioxidant capacities     in patients with chronic kidney disease. The purpose of this study is going to investigate     the effects of protein formula on renal function, homocysteine , oxidative stress and     antioxidant capacities in patients with chronic kidney disease. One hundred and twenty     patients with end stage renal disease (stage 2~4) who meet the inclusion criteria will be     recruited from Taichung General Veterans Hospital, Taichung. Participant patients will be     blinded and randomly assigned to either the placebo (n = 60) or low protein formula (n = 60)     for 12 weeks. Data on demography, anthropometry and medical history will be collected, and     fasting blood samples and 24 h urine samples will be obtained at week 0, 12 and 24 during     intervention period. The levels of hematological, plasma and erythrocyte PLP, plasma     pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum vitamin B-12,     homocysteine, lipid peroxidation indicators, glutathione, total antioxidant capacity and     antioxidant enzymatic will be measured. Twenty-four hour urine volume will be recorded and     urine creatinine and urea nitrogen will be analyzed. Creatinine clearance rate will be     measured. Hopefully, the results of this study could provide more pictures on beneficial     effects of low protein formula on renal function, plasma homocysteine, oxidative stress and     antioxidant capacities in patients with chronic kidney disease.   "
98337|NCT01999010|"     Mood journaling is a cornerstone of self-management in major depressive disorder (MDD).     Research over the last decade has shown that electronic mood journals are superior to paper     ones. One potential advantage of mental health telemetry (MHT), which use cell phones to     collect mood journal data, is that electronic journal data can easily be converted into     graphical records, allowing people living with MDD to readily spot trends, correlations, or     patterns in ways that would be quite challenging using paper diaries. This information should     make it easier to recognize and evaluate changes in mental health status -- the first two     steps in the process of self-management. The investigators will develop and deploy a     visualization module for patients with which to explore their own MHT data sets on the same     cell phones which they record their journals, and test the investigators hypotheses that     their enhanced MHT system will (i) improve patients' ability to self-manage MDD and (ii)     enhance their quality-of-life.      The study is a non-randomized, un-blinded, A-B-A' (modified single-subject withdrawal design,     with user choice of treatment or withdrawal in the A' stage) study, to explore the utility of     MHT as a tool for enhancing self-management and QoL for persons living with MDD. The aims of     this study are to explore the impact of MHT on subjects' self-management and QoL, and to     gauge participants' perceptions of MHT's utility.   "
98338|NCT01998997|"     To address the feasibility of implementing a randomized, educational intervention to prevent     delirium, directed at family members of hospitalized older (70 years of age or older) medical     in-patients. Specifically rates of recruitment and acceptance rates of such an intervention     to family members will be assessed. An estimate of the effect size of this intervention will     also be calculated. This is a pilot study. The investigators hypothesize that this     intervention will be feasible and agreeable to family members to perform, with acceptance     rates exceeding 80%.   "
98339|NCT01998984|"     This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2     trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily     treatment for 2, 3 or 4 consecutive days compared to vehicle gel   "
98340|NCT01998971|"     The purpose of this study is to evaluate the safety, tolerability, and dose regimen of     daratumumab when administered in combination with various treatment regimens for the     treatment of multiple myeloma.   "
98343|NCT01998932|"     Chronic venous ulceration of the lower limb poses a significant problem to patients and     healthcare providers alike. 1% of the population of Western countries have either an open or     healed chronic venous ulcer.      However, the pathophysiological abnormalities are not entirely clear in how raised venous     pressure translates into the changes seen in the skin culminating in an open ulcer. The     standard treatment of this condition in the United Kingdom is to undertaken compression     bandaging of the lower limb.      In order to further their knowledge of venous ulceration, the investigators seek to determine     the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing     the groups into healing and non-healing wounds, the investigators may be able to demonstrate     a difference in the biological profile.      This work may provide insights into predicting who will respond to treatment and targets for     treatment in the future.   "
98602|NCT01995539|"     The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose     Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients     in India with type 2 diabetes to get a better understanding of their patient's metabolic     fluctuations, and support appropriate therapeutic intervention.   "
98344|NCT01998919|"     This study will evaluate the efficacy and safety of sequential administration of Tarceva and     gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer.     Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4     week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The     anticipated time on study treatment is until disease progression or unacceptable toxicity.   "
98345|NCT01998906|"     This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing     regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women     with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel     observational study patients with HER2-negative disease will receive the same chemotherapy     without Herceptin.   "
98346|NCT01998893|"     This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with     relapsed low-grade centroblastic centrocytic non-Hodgkin`s lymphoma. Patients will receive     once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a     second time in case of relapse (defined as progression after complete or partial response).     The anticipated time on study treatment is <3 months.   "
98347|NCT01998880|"     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of     obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles     of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles     2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv     infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil     alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression     and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.   "
98348|NCT01998867|"     1. To develop a database containing matched information from dynamic tests of postprandial          glycemic control (OGTT or MMTT), results of a broad panel of fasting biomarkers, and          clinical information related to diabetes risk obtain through subject interview.        2. To use the database to identify fasting biomarkers and associated algorithms to best          predict parameters derived from dynamic tests (OGTT or MMTT) such as Insulin Glucose          Tolerance (IGT), impaired first phase insulin response, etc., controlling for clinical          information such as current medication use.   "
98349|NCT01998854|"     Study is intended to evaluate the one-year safety and clinical status of patients treated for     symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio     frequency (RF) ablation system. Particular attention will be directed to recording safety     outcomes including incidence of uterine cavity synechiae. In addition, information on quality     of life will be collected.      Overall study duration (first patient enrolled through last patient exit) will be comprised     of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment,     and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an     individual patient, once enrolled, will be approximately 1 month for baseline observations     and treatment scheduling, and 12 months for follow up after treatment for a total duration of     approximately 13 months.   "
98350|NCT01998841|"     This randomized, double-blind, placebo-controlled, parallel group, adaptive study will     evaluate the efficacy and safety of crenezumab versus placebo in individuals who carry the     PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive     impairment due to AD or dementia due to AD and are, thus, in a preclinical phase of AD.     Participants will be randomized 1:1 to receive either crenezumab or placebo subcutaneously     every 2 weeks for 260 weeks. The study will also include a cohort of PSEN1 E280A mutation     noncarriers who will be dosed with placebo only.   "
98351|NCT01998828|"     This open-label study is to determine the safety and efficacy of momelotinib in participants     with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet     received treatment with a Janus kinase (JAK) inhibitor.   "
98364|NCT01998659|"     The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102     in healthy subjects after single oral dosing.   "
98365|NCT01998646|"     The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of     single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This     study will also explore the effect of food on the PK of ASP4058.The food-effect crossover     group was open-label treatment with no placebo control.   "
98391|NCT01998308|"     Study design:      Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model:     Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.      Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.      Primary outcome measures:        -  Lower extremity functional scale        -  Visual analogue scale        -  Range of motion        -  Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December          2012 Estimated study completion date: June 2013 Estimated primary completion date:          December 2013   "
98352|NCT01998815|"     The purpose of this study is to examine how physical activity and lifestyle factors influence     postoperative recovery and postoperative complications after bariatric surgery.      The hypothesis is that physically active people, with a healthy alcohol consumption and non     smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations     and fewer re-operations, fewer complications as well as a faster recovery after a surgical     procedure.      The investigators also hypothesize that possible risk factors for non-surgical postoperative     complications e g abdominal discomfort are also life-style related factors such as smoking,     high alcohol consumption, low level of physical activity, as well as other risk factors such     as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of     anxiety and/or depression, difficulties with coping with the changed food intake regimen     after obesity surgery, and generally high sensitivity for painful-sensations and nausea.      First aim of this study is to investigate how life style factors prior to obesity surgery are     related to hospital stay, sick-leave, immediate postoperative complication rates and the rate     of resumption of QoL and normal physical function.      The second aim of the study is to identify risk factors for the development of chronic     abdominal discomfort and dumping symptoms after obesity surgery.   "
98353|NCT01998802|"     This is a phase III double-masked, randomized, controlled study evaluating the efficacy of     EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects     with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up     to approximately 50 centers in the United States will be screened, enrolled into the study.   "
98354|NCT01998789|"     The purpose of this study is to evaluate the efficacy of an everolimus conversion (EVR)     protocol as compared to the standard tacrolimus (TAC) based protocol in liver transplant     recipients, as determined by renal function, rejection rates, and progression to fibrosis (in     HCV positive subjects). Additionally, safety profile and tolerability of these regimens will     be assessed.   "
98355|NCT01998776|"     ASA is the most commonly drug used worldwide for prevention of cardiovascular diseases.     However, ASA is increasingly recognized as a culprit for small bowel bleeding. Small bowel     bleeding is notoriously difficult to diagnose because it is beyond the reach of conventional     endoscopy. The advent of wireless, video capsule endoscopy has revolutionized the     visualization of small bowel. Capsule endoscopy is a pill that contains a tiny camera for     capturing pictures of the small bowel after being swallowed. Currently, capsule endoscopy is     a recommended noninvasive approach of identifying the source of small bowel bleeding.      Management of ASA-associated small bowel bleeding is a major clinical challenge since there     is not a single effective treatment for small bowel ulcer, and continuation of ASA increases     the risk of recurrent small bowel bleeding. However, discontinuation of ASA exposes patients     to thrombotic complications. Suppression of prostaglandin synthesis is an important mechanism     of ASA-induced small injury. Consistent with this theory, preliminary data from a case series     showed that misoprostol, a prostaglandin analog, healed small bowel ulcers in ASA users.     However, the efficacy of misoprostol in healing ASA-associated small bowel ulcers has not yet     been confirmed by prospective randomized trials.      This double-blind clinical trial tests the hypothesis that misoprostol can heal small bowel     ulcers in Aspirin users complicated by small bowel bleeding.   "
98356|NCT01998763|"     This is a double-blind, randomized, placebo-controlled trial. Based on inclusion and     exclusion criteria, 400 eligible volunteers, who were 20-45 years, with 25-hydroxyvitamin D     between 12.5-50 nmol/L and BMI between 18.5-28 kg/m2, were enrolled and randomly assigned to     placebo or 2000 IU/d vitamin D3 arm, after taking placebo for one week. The study protocol     was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University,     Shanghai and all participants provided written informed consents.In this 2-arm RCT we aimed     to systematically investigate the effect of:        1. vitamin D3 supplement on serum 25(OH)D levels and the modifying factors;        2. genetic and non-genetic variants on vitamin D bioavailability;        3. vitamin D3 supplementation on metabolic profiles and circulating bone-turnover markers   "
98357|NCT01998750|"     This study aims to investigate genetic causes of early childhood obesity.      We will enroll children with severe early onset obesity (BMI > 99th percentile) diagnosed     prior to 6 years of age. We will ask questions about their health, eating behavior and     perform a brief physical examination. We will collect saliva or blood to perform genetic     testing. We will also invite family members to participate in the genetic study.   "
98358|NCT01998737|"     Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture     risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are     diagnosed only after several fractures. Furthermore, the progressively aging population will     increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic     patients are not diagnosed and does not receive treatment for their condition.      In this study we aim to investigate the strength of Density Index (DI) for prediction of     proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI     for osteoporosis diagnostics by using the International Society for Clinical Densitometry     guidelines. In addition we aim to investigate how many additional women would be identified     for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to     DXA.      The investigators will start and organize a multicenter study in 5 osteoporosis clinics in     Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal     women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the     FRAX questioinnaire will be asked from everybody attending the study.      Clinical hypotheses:        1. Cortical bone thickness is decreased in osteoporosis.        2. Patient age, weight and height are related to BMD status and therefore are needed in BMD          estimation (Density Index).        3. Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.        4. Fracture risk factors (FRAX) and point-of-care bone density measurement together have          significantly higher sensitivity and specificity for osteoporosis/treatment decisions          than one method alone.   "
98359|NCT01998724|"     The main purpose of this study is to determine the feasibility and effects of a 6-month tai     chi exercise program as compared to a 6-month group walking program and standard care for     patients with COPD that have recently completed a pulmonary rehabilitation program.   "
98366|NCT01998633|"     HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation,     polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent     primary immune disorders that are typically fatal without Hematopoietic Cell Transplant     (HCT). However, transplant is often complicated by inflammation, infection and other     co-morbidities. In addition, these disorders have been shown to be cured with partial     chimerism, making them an ideal target for the use of reduced intensity approaches, where a     portion of patients may not achieve full donor chimerism, but instead achieve stable mixed     chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with     decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH     (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and     unstable chimerism remain challenges. An institutional case series from Cincinnati Children's     Hospital demonstrated full or high-level chimerism and improved durable engraftment using     intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the     efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH     as well as other primary immunodeficiencies where allogeneic transplant with RIC has been     shown to be feasible and stable chimerism is curative.   "
98367|NCT01998620|"     This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients     with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.   "
98368|NCT01998607|"     Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is     well-recognized in patients with advanced cancer. Detailed information regarding this risk is     specified in the Summary of Product Characteristics (SPC). The statements in the SPC are the     most important mechanism for minimizing the risk for ONJ. The study objective is to measure     the knowledge of oncology practitioners prescribing XGEVA® regarding the content pertaining     to ONJ in the SPC after commercial availability.   "
98369|NCT01998594|"     The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space     created by removal of the trapezium improves the subject's outcome and subsequent     functionality of the basilar joint arthroplasty procedure.   "
98370|NCT01998581|"     This is a multicenter, double-blind, randomized, controlled study of the safety and     effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and     perioral enhancement.   "
98371|NCT01998568|"     The investigators conduct this study to access the effect of corneal edema (the investigators     are particularly interested in those who have the clinical central corneal edema) on the     variation of intraocular pressure values measured by 3 commercial-available tonometers     compare to the current gold standard tonometer; Goldmann applanation tonometer.   "
98372|NCT01998555|"     The purpose of this study is to evaluate medical cost-effectiveness, reduce the psychological     risk factors( including hostility, anxiety, depression, and perceived stress) in coronary     artery disease (CAD) patients and enhance the regulation of the autonomic nervous system     (including respiration rate, heart rate, distal blood vessel pulse, and finger temperament)     through web-based cognitive -behavioral group therapy.   "
98373|NCT01998542|"     The purpose of this study is to determine the safety and tolerability of personalized     anti-cancer vaccine AlloVax(TM) in Subjects with confirmed recurrent or metastatic squamous     cell carcinoma of the head and neck (SCCHN) who cannot be treated with surgery, chemotherapy     or radiation. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell     Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as     an adjuvant. The combination of CRCL and AlloStim(TM) is designed to provide all the key     components necessary to develop tumor-specific immunity creating the inflammatory environment     necessary to overcome the HNC immunosuppressive environment, breaking tumor immune tolerance,     and provision of specific HNC antigens for generation of a specific adaptive anti-tumor     response.   "
98374|NCT01998529|"     The goal of this clinical research study is to find the highest tolerated dose of heated     cisplatin that can be given to patients with lung tumors. The safety of this drug will also     be studied.   "
98375|NCT01998516|"     Scientific Background      Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest     which focuses on personality traits and abilities enabling people to cope with both their own     feelings as well as those of others. The Mayer-Salovey-Caruso-Emotional-Intelligence-Test     (MSCEIT) (1) represents a valid and reliable instrument which exclusively covers the     emotional components of social cognition. Recent findings indicate, that social cognitive     impairments are useful vulnerability indicators and that EI could be an endophenotype for     schizophrenia and bipolar I disorder (BD I). To confirm the endophenotype theory, studies     concerning EI in relatives of schizophrenia and bipolar patients are needed. To date, studies     on EI in BD patients as well as in first degree relatives of patients with schizophrenia or     BD haven`t been conducted yet. Accordingly, the current study focuses on the four categories     assessed by the MSCEIT and aims to compare the task performance of patients, their first     degree relatives and healthy control subjects. We assume that the task performance of     relatives lies between that of patients and controls. The confirmation of this assumption     would verify the trait marker hypothesis and could be a next step to identify a heritable     endophenotype for schizophrenia and BD.      Hypotheses      Compared to healthy control subjects patients suffering from schizophrenia or BD I show     deficits in EI. Siblings of patients with schizophrenia or BD I show deficits in EI and their     task performance lies between that of patients and healthy controls. Deficits in EI are more     pronounced in schizophrenia patients than in patients with BD I and are more pronounced in     siblings of schizophrenia patients than in siblings of patients with BD I. Independently of     diagnosis, deficits in EI affect patients' functional and subjective outcomes.      Methods      Emotional Intelligence will be examined using the MSCEIT in patients with schizophrenia,     siblings of schizophrenia patients, patients with BD I, siblings of BD I patients and healthy     volunteers matched for age, sex, and educational level. Structured clinical interviews     according to DSM-IV (M.I.N.I. + SCID II) will be carried out to assure the diagnosis of     schizophrenia or bipolar disorder as well as to detect (comorbid) Axis I and Axis II     psychiatric disorders (patients, siblings, control subjects). Functional outcome will be     assessed by using the GAF (Global Assessment of Functioning Scale) and the PSP (Personal and     Social Performance Scale), subjective quality of life will be examined using the BELP     (Berliner Lebensqualiätsprofil). The MWT-B (Multiple choice vocabulary test) will be used to     assess premorbid intelligence.   "
98376|NCT01998503|"     This randomized phase III trial is studying the side effects and how well giving induction     therapy with bortezomib and dexamethasone followed by autologous stem cell transplantation     (ASCT) compared with ASCT alone in treating patients with newly diagnosed renal AL     amyloidosis. In this prospective, randomized control study, patients with newly diagnosed AL     amyloidosis who met the criteria for ASCT were randomized to receive 2 cycles of BD as     induction therapy followed by ASCT (BD+ASCT) (arm 1) or to receive ASCT alone as an initial     treatment (arm 2). Hematologic and organ responses were evaluated every 3 months after ASCT.     All the patients should be followed up for 12 months.   "
98392|NCT01998295|"     Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia     and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is     not known whether the problem exist in Tanzania. This study assessed parasite clearance time     and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among     children with uncomplicated malaria.   "
98377|NCT01998490|"     The overall research aim of this study is to investigate changes in measures related to the     risk of falls among elderly with dementia participating in animal-assisted or robot-assisted     interventions. In addition the study will investigate how knowledge transfer occurs among     involved health personnel, and how knowledge is refined and transformed as practical     competence. The design will be a prospective and cluster randomized multicenter trial, but     mixed-methods will be used to target different outcomes. The study population will be elderly     (age above 65) at nursing homes diagnosed with dementia, or having a cognitive deficit. The     intervention will consist of 30 minutes sessions with animal-assisted activity or     robot-assisted activity two times a week for 12 weeks in groups of 4-6 participants. Control     groups will receive treatment as usual. Research questions:        1. Is there an effect in use of ordinary and optional medication among elderly persons with          dementia at nursing homes participating in animal-assisted or robot-assisted          interventions compared to a control group?        2. Is there an effect on agitation, restlessness and depression among elderly persons with          dementia at nursing homes participating in animal-assisted or robot-assisted          interventions compared to a control group?        3. Is there an effect on social interaction, activeness and wellbeing among elderly persons          with dementia at nursing homes participating in animal-assisted or robot-assisted          interventions compared to a control group?   "
98378|NCT01998477|"     The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18     years of age who are at risk of complications of influenza disease due to underlying     diseases.   "
98379|NCT01998464|"     Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the     retina, the tissue that lines the inside of the eye. This inflammation may occur on its own     or as a result of an infectious, cancerous, or inflammatory disorder.      Optical coherence tomography (OCT) is an imaging technology that can perform non-contact     cross-sectional imaging of retinal and choroidal tissue structure in real time. It is similar     to ultrasound imaging, except that OCT measures the intensity of reflected light rather than     sound waves.      The purpose of this study is to see if non-invasive OCT technology can diagnose retinal     vasculitis as well as the more invasive fluorescein angiography, which requires an injection     of dye into the vein of an arm of a patient. The study will also compare the mapping of blood     vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT.   "
98380|NCT01998451|"     We found a new Double sphincter which located in the neck of gallbladder，we supposed it may     be related to control pressure of bile duct.Its formation is related to genetic factors.   "
98381|NCT01998438|"     Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease     perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is     still unknown. We use three different doses to find which is the optimum dose of tranexamic     acid in cardiopulmonary bypass cardiac surgery.   "
98382|NCT01998425|"     The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung     cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion     of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating     immune escape in NSCLC patients.   "
98383|NCT01998412|"     The study will include any patient treated with Iluvien at designated sites in European     countries where marketing authorization has been granted in order to obtain broader safety     and usage information.   "
98384|NCT01998399|"     The purpose of this study is to determine if the drug ticagrelor will be an effective     treatment for patients with severe community acquired pneumonia. The primary objective is to     reduce all-cause mortality in the ticagrelor group compared to the placebo group.   "
98385|NCT01998386|"     The specific objective of this study is:        -  Evaluate and quantify colorimetric changes in young permanent anterior teeth;        -  Compare the efficiency and efficacy of three gels used for self-administered home          whitening and an over the counter whitening strip;        -  Analyze the increase in dental sensitivity in adolescent patients submitted to home          whitening with 6% and 7.5% hydrogen peroxide with and without the addition of calcium          (whitening strips);        -  Assess sensitivity, comfort and acceptance of whitening strips by patients;        -  Assess patient satisfaction with the method and material used for home whitening.   "
98386|NCT01998373|"     Abstract      Background:      It is documented that some patient education interventions, preferably with a behavioral     component included, may improve pain, disability and moods Purpose of the study: the purpose     of this study was to improve the quality of life and reduce pain in rheumatoid arthritis     patients.      Methods:      Patients were allocated to a patient training intervention group and patient without training     intervention group. Both groups received routine treatments while the patient training     intervention group, in addition to the routine treatments received training booklets and     participated in the training workshop. All the extracted data from the written questionnaire     were collected and analyzed using SPSS software.   "
98387|NCT01998360|"     This study will evaluate a new, minimally-invasive surgical circumcision technique for men,     which is easy to learn and perform, is safe, and is associated with high patient satisfaction     and excellent cosmetic results.   "
98388|NCT01998347|"     There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus     5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to     40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical     trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as     effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with     cisplatin is evaluated by median survival time, progression free survival,and response rate.   "
98389|NCT01998334|"     Systemic Inflammatory response syndrome(SIRS) is common in patients with severe acute     pancreatitis (SAP) in early stage. Continuous Blood Purification (CBP), especially Continuous     Veno-Venous Hemofiltration(CVVH) is proved to have an important role in SAP patients to     control SIRS. But the detail treatment for this is controversial. In this study, the     investigators aim to evaluate the different effects of three kinds of treatment protocols     which is CVVH 6h,continuous venovenous hemodiafiltration(CVVHDF) 6h,CVVH 10h for first three     days in SAP patients. Compare the vital sign, SIRS parameters, and others between these three     groups. This study will try to find a better way for CBP in patients with SAP   "
98393|NCT01998282|"     DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are     collaborating on a project financed by carbon credits that will distribute household-based     water filters and high-efficiency cook stoves to approximately 600,000 households in Rwanda.     Prior to the full roll out of the campaign, the implementers are conducting research in     connection with a distribution among 2000 households in western Rwanda. The objective of this     matched cohort study (Phase 1B)are to investigate whether the filters and stoves delivered in     October 2012 are still performing and in use, to determine whether they are associated with     reductions in exposure to pathogens from drinking water and stoves, and to assembly     information on health and other conditions necessary for the design of a large scale health     impact evaluation.   "
98394|NCT01998269|"     The study objective is to develop and test a Measure of Drug Self-Management for use in     clinical settings among patients with hypertension and diabetes.      While medication non-adherence is a highly recognized public health and patient safety     concern, it is rarely assessed in a routine and consistent manner in clinical settings. With     the aging of the US population and rising rates of chronic disease, an increasing number of     adults are being prescribed multi-drug regimens that require greater self-management skills.     Despite the complexity of medication use, adherence has most commonly been measured as a     limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has,     over time, simplified how we think of prescription (Rx) medication use and directed attention     away from the full range of tasks associated with effective Rx self-management. The field of     health literacy research has deconstructed these tasks in considerable detail in recent     years, and can offer insight into a more comprehensive measurement of patients' outpatient Rx     use.      There is a clear need for a brief, yet inclusive, measure of adherence that can be used in     clinical settings to routinely assess patients' use of complex Rx regimens. Such an     assessment could be used to guide clinicians in addressing specific patient challenges to     safe and appropriate medication use. In response to this need, our study proposes to develop     a new assessment of medication self-management. This unique measure will utilize health     literacy best practices to promote patient comprehension and ease-of-use; it will also be     tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the     tool will be available in both English and Spanish to support use among diverse patient     populations. Our study aims are to:        1. Develop and refine a Measure of Drug Self-Management (MeDS) prototype.        2. Inform the content, structure and delivery of the MeDS through targeted discussions with          patients, providers and information technology specialists.        3. Test the reliability and validity of the MeDS among patients with diabetes and          hypertension      H1: The MeDS will strongly correlate with other self-report adherence measures.   "
98395|NCT01998256|"     Though AV optimization has become a cornerstone in optimization of patients with a cardiac     resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients     with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical     practice. Some patients with a BIC pacemaker have a too short AV delay (AVD), secondary to an     important interatrial conduction delay (IACD), which can lead to an atrial dyssynchrony     syndrome. Others have a too long AV delay, also leading to a suboptimal diastolic filling     time. Some patients may not need an optimization. Our aim was to evaluate the effect of AV     optimization in all comer ambulatory patients with a BIC pacemaker on clinical outcomes, with     a correlation to atrial pathophysiology, since until now existing evidence only emphasizes a     possible hemodynamic benefit of this non invasive intervention.   "
98396|NCT01998243|"     Introduction: bariatric surgery shows an important morbidity and there are some reports that     have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity.      Patients Methods: Since 2009 we are performing a randomized and prospective study to assess     the usefulness of (IGB-BIB®) before bariatric surgery [sleeve resection (SR) or gastric     bypass (GB)] group A vs a control group B with the same type of surgical procedures but     without preoperative IGB-BIB. All patients coming for both groups were followed at 4-week     intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the     dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight     loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more     than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least     30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and     hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery was     associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB     failure.Intragastric balloon failure was considered when the weight loss is less than 10%     from the initial weight. We defined severe complication whenever the patient had to be     admitted in the hospital after discharge, new surgeries or transfusions were required or the     hospital stay was longer than 7-10 days.   "
98397|NCT01998230|"     The purpose of this study is to determine the feasibility of early oral food intake     postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence     confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with     esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in     patients with esophagectomy, the preference for this modality also rests on the traditional     but undocumented reluctance to allow food at will. These assumed hazards of allowing normal     food in the immediate postoperative period have not been scientifically tested and should be     viewed against both the benefits and side effects of any artificial feeding modality. Whether     early oral feeding after esophagectomy affects the incidence of life-threatening surgical     complications, shortens the recovery time of bowel function and the postoperative hospital     stay, improves postoperative quality of life in comparison with artificial feeding modality     remains unclear. The investigators compared a routine of allowing liquid food at will from     the first day after surgery with a routine of nil-by-mouth and enteral nutrition for the     first 7 postoperative days. The main endpoint is the incidence rate of complications.   "
98398|NCT01998217|"     Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an     effective approach for stone drainage and pain relief, and general or epidural anesthesia has     been reported for such procedure. Single infusion of remifentanil has been described in ESWL     of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover,     single infusion of remifentanil might induce several complications, such as postoperative     nausea and vomiting. The investigators attended to investigated whether combination of     flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.   "
98399|NCT01998204|"     Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The     investigators clinical experience showed a trend of delayed emergence among patients     undergoing deep brain stimulator (DBS) implantation and pulse generator placement under     general anesthesia. Abnormal pharmacodynamics might be present among these patients, which     had never been investigated.   "
98400|NCT01998191|"     TITLE A randomized controlled trial to assess the best method for evaluating avoidable     mortality in hospitals using medical record review.      DESIGN Randomised controlled trial This trial will be conducted in concordance with the     CONSORT guidelines for randomised controlled trials.      AIMS Compare explicit versus implicit case review methods for detecting avoidable mortality     in patients who have died in hospital Assess the accuracy and efficiency of physicians versus     nurses in detecting avoidable mortality in patients who have died in hospital      OUTCOME MEASURES Rate of adverse event detection between explicit and implicit review methods     Type of adverse event detection between explicit and implicit review methods      Kappa score of agreement for inter-rater reliability for the above outcomes:        -  Between individual reviewers within using the same review method        -  Between different reviewer types.      PARTICIPANTS Physician reviewers and nurses No patient participation. Case records of     patients who had inpatient hospital mortality will be reviewed.      ELIGIBILITY Over 18, Able to consent, English Language Speaking, Able to participate in case     note review training, appropriate level of clinical experience.      DURATION 2 years with extension if required and reviewed.   "
98401|NCT01998165|"     The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva     /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during     maintenance of general anesthesia.   "
98402|NCT01998152|"     The purpose is to study the effect of individualized nutritional counselling compared to     usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal     cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment     intensity, physical functioning, quality of life and survival will be studied.We hypothesize     that patients in the intervention arm benefit from individualized nutritional counseling.   "
98403|NCT01998139|"     Sepsis is a major global health problem, leading to substantial morbidity and mortality     despite medical care. The initial diagnosis of sepsis is a clinical challenge, as it is based     on nonspecific systemic criteria. Excessive endothelial activation is a cardinal feature of     sepsis and contributes to microvascular leak, edema, circulatory shock and organ failure.     Activated endothelial cells shed endothelial microparticles (EMPs) which can be measured in     plasma and are found at low levels in healthy subjects. Elevated EMPs have been reported in     sepsis, but whether their effect is beneficial or deleterious is unclear. In this context, we     hypothesize that circulating EMP levels can be assessed as a biomarker differentiating sepsis     from non-sepsis critical illness. This may also suggest that EMP levels correlate with 30-day     mortality. We propose to measure circulating EMPs at ICU admission in subjects with suspected     sepsis. Final diagnoses will be adjudicated using standard criteria and 30-day mortality     ascertained. Subjects determined not to have sepsis will serve as the control group. EMP     levels will be correlated with diagnosis to ascertain the utility of EMP levels as a     diagnostic biomarker for sepsis. For those subjects with proven sepsis, EMP levels will be     correlated to 30-day mortality to assess EMP level as a prognostic marker in sepsis.   "
98404|NCT01998126|"     The goals of the overall study are to evaluate a recommended phase 2 dose and the short and     long term toxicities of the combinations. This is a modified phase I trial of immune     checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib or     erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma kinase)     or EGFR (epidermal growth factor receptor) mutation.      The goals of the overall study are to evaluate a recommended phase 2 dose and the short and     long term toxicities of the combinations.   "
98405|NCT01998113|"     Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's     trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM),     additional studies of oral agents for the treatment of GDM have been published     (observational, randomized controlled trials (RCT), and trials using other drugs like     metformin).      Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4     RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs,     the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing     metformin vs insulin).      Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the     evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize     this evidence using meta-analysis tools. Specifically, investigators aim at producing     distinct meta-analyses for each one of the three drug comparisons. This information is not     available in the literature since the most recent systematic reviews specifically dealing on     oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or     have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)   "
98406|NCT01998100|"     The purpose of this study is to examine the efficacy of exercise + therapy to therapy alone     to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing     symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition the     two strategies (i.e., exercise + therapy and therapy alone condition) will be compared in     terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to     support the survival of existing neurons and stimulate the growth of new neurons and     synapses. BDNF is important to learning and memory in general and therefore may be associated     with the learning and memory as it relates to PE and corresponding symptoms PTSD improvement.   "
98437|NCT01997697|"     Recent studies show that overweight people have a greater sensitivity to the rewarding aspect     of food due to the disturbance of the dopaminergic system. These perturbations lead to a     greater amount of food to satisfy this rewarding aspect. Then, this rewarding aspect to food     would also facilitate food intake related to emotions, whether they are positive or negative.     However, the food intake in response to emotions can be modulated by physical activity. But,     there are no interventional studies in the literature examining the behavioral and biological     factors related to emotional eating together with the fact, there are few data on the     explanatory mechanisms. The purpose of the study is to evaluate the predictive factors of     emotional eating 6 months after a behavior change program adapted to the motivational state     and to identify the its underlying mechanisms   "
98603|NCT01995526|"     The main purpose of this study is to evaluate how the body processes the study drug known as     insulin peglispro and how the study drug affects blood sugar in healthy male Japanese     participants. This study will also evaluate safety of the study drug. The study will last up     to 46 days for each participant, not including screening.   "
98407|NCT01998087|"     In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third     have stopped, and by six months only half are still providing any human milk for their     babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers     exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of     exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other     pregnancy and parenting related written information is routinely provided to expectant     couples. In our study we would like to find out whether providing written breastfeeding     information in pregnancy and breastfeeding focused support phone calls during pregnancy and     after the birth of the baby result in better outcomes than providing general     pregnancy/parenting information and support phone calls. This will be tested by randomising     women, attending their primary health care provider for routine antenatal visits between 20     and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an     intervention focused on general pregnancy and parenting issues, and to a non-intervention     control group. Women will be followed-up for 6 months after the birth of their baby and data     will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy,     breastfeeding difficulties, social support and attitudes toward infant feeding.   "
98408|NCT01998074|"     The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly     developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.   "
98409|NCT01998061|"     There have been reports suggesting that continuous administration of epidermal growth factor     receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual     disease progression was observed after the establishment of clinical benefit from EGFR-TKIs.     However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not     been formally evaluated.   "
98410|NCT01998048|"     Glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the     scapular glenoid plate especially in the anteroinferior direction. Surgical treatment of     shoulder instability aims at restoration of shoulder stability. The purpose of this trial is     to investigate the difference in outcome after arthroscopic Bankart operation compared with     open Latarjet operation in the treatment of a residual instability after a traumatic primary     dislocation in young males.   "
98411|NCT01998035|"     This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I     followed by a disease focused phase II.      The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and     dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in     patients with lymphoma. The safety and toxicity of this combination will be evaluated     throughout the entire study.      If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is     established, the phase II part of the study will be initiated.      Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and     romidepsin for patients with relapsed or refractory T-cell lymphomas.   "
98412|NCT01998022|"     Numerous studies highlight the insufficiency of blood pressure control in treated     hypertensive population [1].      As shown in the MONICA study, increased cardiovascular mortality is found in Alsace compared     to other french regions. The incidence and prevalence of diabetes and obesity are likely     explanatory factors leading to this excess mortality [2].      Furthermore, the incidence and prevalence of alsacian patients with end-stage renal failure     (ESRD) is also higher than the national average. The high prevalence of diabetes,     hypertension and obesity in this population is also probably responsible for the high     prevalence of ESRD [3].      Opportunities to prevent the progression of kidney disease involve an optimal control of     treatable evolutionary factors.      Beyond control of diabetes and obesity, optimization of blood pressure control are an     important factor to consider, as national and international guidelines recommend lower blood     pressure targets in this population [4]. Knowledge of the disease and treatment goals are a     key component of hypertensive patient management. Studies have shown that the knowledge of     hypertensive disease and therapeutic targets were correlated with treatment compliance and     with the rate of blood pressure control [5]. Patient education and participation of     non-medical actors (nurses, pharmacists, …) are likely to improve the management and     treatment compliance of these patients [6]. To our knowledge, no investigation has been     performed in our region to determine the epidemiological characteristics, the knowledge level     and blood pressure control in the population of hypertensive patients. The main objectives of     this observational study are to evaluate, in a treated hypertensive population:      the knowledge level of the blood pressure treatment goals, the impact of patient knowledge on     this blood pressure control, the potential impact of the patient's comorbidities on his blood     pressure control.      Such a study should provide the basis for the feasibility of a large survey.   "
98413|NCT01998009|"     The objective of this study is to compare the performance characteristics or accuracy of     different in-home screening tests for colorectal cancer (fecal occult blood tests), among     patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria     and agree to participate in the study are asked to perform one guaiac and two immunochemical     fecal occult blood tests at home prior to their colonoscopy. After the patient has completed     and sent in the test kits, the patient then undergoes their previously scheduled colonoscopy.     Accuracy and performance characteristics for each type of fecal occult blood test, including     sensitivity, specificity, test positivity rate and positive predictive value for advanced     colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be estimated by     comparing the fecal occult blood test results with the results of the colonoscopy.   "
98414|NCT01997996|"     Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP)     where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia, TVM     are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M (Trademark)     is based on a highly flexible material which is partially absorbable. We suggest that     PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used     for the treatment of younger and/or sexually active women. This study observes women who are     routinely treated with PROLIFT+M with regard to their sexual function before and after the     surgery. The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.   "
98415|NCT01997983|"     The investigators believe that this study is of importance of several aspects:        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the          current instillation mode.        2. It will demonstrating safety of intravesical instillations of BTX mixed with TC-3 gel in          IC patients        3. If proved effective or partially effective, this mode of treatment will serve as a basis          for large feasibility study exploring its safety and efficacy aspects.   "
98416|NCT01997970|"     This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when     implementing active workstation at offices compared to conventional office work. The primary     hypothesis is that this implementation will lead to a significant increase in time spent     walking per day.   "
98604|NCT01995513|"     The purpose of this study is to determine if continued treatment with Enzalutamide is     effective in patients with metastatic prostate cancer.   "
98417|NCT01997957|"     Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world     and causes death of about 600000~1000000 people each year. Since 1990s, hepatic carcinoma has     become the second carcinoma killer in China. Surgical resection or liver transplantation is     the only method possibly able to cure hepatic carcinoma. However, due to multiple tumors or     poor hepatic function reserve in cirrhosis, surgical treatment is suitable for only a small     portion of patients (11.9%-30.1%). Therefore, in clinical practice, transarterial     chemoembolization (TACE) or transarterial embolization (TAE) is a preferential and standard     treatment of unresectable advanced hepatic carcinoma and has notable advantages in     controlling local tumors of the liver. Hepatic arterial infusion of oxaliplatin after TACE     can significantly increase the local doses of chemotherapeutic agents in the liver, kill     micrometastases and residual foci after embolization and demonstrate outstanding efficacy for     treating concomitant portal and hepatic vein tumor thrombi. S-1 is a chemotherapeutic agent     with convenient use and definite efficacy and, when used concomitantly with TACE,     theoretically can not only effectively control intrahepatic foci but also prevent and control     extrahepatic metastatic foci. However, this hasn't been verified in clinical application.     This study is intended to investigate efficacy and safety of the combination treatment so as     to provide a more effective and safety way for treating patients with advanced hepatic     carcinoma (Barcelona stage-C patients with concomitant portal vein tumor thrombi or     extrahepatic metastasis).   "
98418|NCT01997944|"     This is an open label study that will be conducted at a single site in China to evaluate the     safety,tolerability and PK/PD profile of multiple dose of recombinant human serum     albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration     of study participation is up to 22 weeks for each subject,including 4 weeks screening period.   "
98419|NCT01997931|"     This prospective randomised controlled trial was designed to assess the effectiveness of the     Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions     in mechanically ventilated ICU patients.      The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS)     monitoring will receive less sedation then those receiving standard sedation management.      The secondary hypotheses are:        1. Patients with BIS have fewer ventilation days than those receiving standard sedation          management.        2. Level of sedation administered will differ according to the critical care experience and          qualification of the nurse.   "
98420|NCT01997918|"     Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell     transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing an     alternative donor is often advocated to maximize chances of a graft versus tumour (GVT)     effect. We and others published that success of this strategy when using an alternative human     leukocyte antigen (HLA) identical donor is limited, at least when acute leukemia is the     underlying disease. The aggressivity of the rapidly proliferating leukemia seems to prevail     over GVT effects. A more potent alloimmune response is observed following haploidentical     HSCT, especially early after haploidentical HSCT. This might be related to a fast and large     expansion of natural killer (NK)-cells. Their alloreactive effect might translate into higher     rates of tumor control. On the other hand, non-relapse complications (treatment related     mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment     and due to delayed immune reconstitution after haploidentical HSCT. The use of a     haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor     has been so far only systematically evaluated in small retrospective single center reports.     Thus, in this multicenter study we aim to collect data on the extent to which participating     centers employ haploidentical transplantation in the situation of relapse after HSCT2.   "
98421|NCT01997905|"     This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when     placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose     is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who     are unable to take Oral Anticoagulants.   "
98422|NCT01997892|"     To describe the time course of hemoglobin concentration in EU hemodialysis patients switched     from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa     (Aranesp).   "
98423|NCT01997879|"     The purpose of this study is to assess systemic safety and absorption of AR-13324 in healthy     volunteers.   "
98424|NCT01997866|"     Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services     and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the     STOP-BANG Scoring Model. (STOP-BANG stands for Snoring, Tiredness, Observed Apnea, Blood     Pressure, Body Mass Index, Age, Neck Circumference, Gender.) Patients with high risk of     Obstructive Sleep Apnea (OSA) will be referred for evaluation and treatment of Sleep Apnea.     They will be followed to determine if treatment of Sleep Apnea improves their quality of life     and decreases their utilization of the Hospital and Emergency Department (ED).   "
98425|NCT01997853|"     Omega 3 fatty acids is one such dietary supplement, known to modulate the host response in     chronic conditions like cardiovascular diseases, rheumatoid arthritis, ischemic     cerebrovascular diseases, osteoporosis by producing Resolvins and protectins without showing     any inadvertent effects.Addition of systemic Omega 3 Fatty Acids with SRP may enhance the     therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory     properties. If proven, this can be used as a routine treatment modality.   "
98426|NCT01997840|"     Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination     with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory     multiple myeloma.      Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide     and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma   "
98438|NCT01997684|"     The use of colonic stenting with elective surgery has been suggested as an alternative     management for acute malignant colonic obstruction, as emergency surgery has a high risk of     morbidity and mortality.      However, the available body of literature addressing their benefit in this setting is     contradictory.      The purpose of this study is to determine the efficacy and safety of colonic stenting with     elective surgery versus emergency surgery in the management of acute malignant colonic     obstruction.   "
98641|NCT01995032|"     The purpose of the study is to show that the intake of L-citrulline and metformin improves     muscle function and delay of progression in patients with Duchenne's muscular dystrophy.   "
98427|NCT01997827|"     Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns     and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment     alternatives. Implant therapy is sometimes impossible, however, because of patient-related     risk factors or economic issues. In such cases therapy with an FDP requires extensive removal     of tooth structure to provide enough space for the restoration and to ensure mechanical     retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or     no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand     for minimal invasiveness and have been used clinically successfully. Sometimes, however,     patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since     the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed     while speaking or smiling or account for a colour change of the abutment teeth. Such patients     profit from an all-ceramic RBFDP. Today, the clinical performance of metal-based and     all-ceramic RBFDPs has not yet been evaluated under randomized controlled conditions. The aim     of this pilot study is to calculate the sample size that allows us to accept the hypothesis     that metal- and all-ceramic RBFDPs are similar regarding their clinical performance with     adequate statistical power.   "
98428|NCT01997814|"     Addition of systemic herbal immunomodulators with scaling & root planing (SRP) may enhance     the therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory     properties. If proven, herbal immunomodulators can be used as an adjunct to SRP.   "
98429|NCT01997801|"     In this prospective double-blinded study, The investigators compared acute postoperative pain     and rescue analgesic demand during postoperative period after robot thyroidectomy between     ketamine and placebo groups.   "
98430|NCT01997788|"     To evaluate the efficacy and the safety of the intrathecal morphine injection in the open     nephrectomy.   "
98431|NCT01997775|"     The purpose of this study is to determine whether metformin is effective in lowering plasma     IL-6 level and improving the treatment response in patients with non-small cell lung cancer   "
98432|NCT01997762|"     The purpose of this study is to determine if resveratrol supplementation preserves beta cell     function and insulin sensitivity in post-partum women following a first diagnosis of     gestational diabetes. We hypothesize that daily supplementation with resveratrol will     preserve beta cell function and insulin sensitivity.   "
98433|NCT01997749|"     The purpose of this controlled, randomized intervention is to investigate whether a fat-based     (ketogenic) diet given for a week has a positive effect on blood sugar, mortality and     function in patients hospitalized with acute stroke compared to the effect of a usual diet.      The study hypothesis is that a ketogenic diet and reduced availability of glucose to the     brain cells will reduce the volume of neuronal damage in the brain and improve function.      The intervention will take place at the neurological units of Glostrup and Bispebjerg     Hospital in Denmark.   "
98434|NCT01997736|"     The purpose of this study is to collect preliminary safety and effectiveness data evaluating     the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic     paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.   "
98435|NCT01997723|"     Obstructive Sleep Apnea (OSA) is under-diagnosed and is associated with increased     cardiovascular morbidity and mortality. Laboratory-based overnight polysomnography (PSG) is     the gold standard in clinical practice to diagnose OSA but has availability, cost, and     resource limitations. In the last decade, an alternative diagnostic strategy, Portable     Monitoring (PM) has emerged with the goal of reducing expense and delays in clinical     management. In contrast to PSG, PM maybe performed unattended in homes, utilize different     neurophysiologic and cardiorespiratory parameters, and may synthesize these data differently.     PM is feasible and is approved by Centers for Medicare and Medicaid Services (CMS) in the     United States. However, the diagnostic utility of PM in minority and underserved populations     is not defined.      African-Americans are more severely affected by hypertension and cardiovascular disease (CVD)     than other ethnic groups and OSA is more common in this population. OSA is a treatable cause     of hypertension. Despite this the impact of timely interventions for OSA on health outcomes     and risk reduction specific to African Americans is unknown.      Purpose of this research: In view of the vulnerability of this population and the potential     for improvement in healthcare access for OSA with home-based diagnosis, this study aims to     establish the feasibility and identify the potential advantages and limitations of home-based     diagnosis of OSA in a high-risk urban African-American population including veterans with     frequently limited access to healthcare.      Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard     laboratory-based PSG in effectively diagnosing OSA in urban African Americans.   "
98436|NCT01997710|"     Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns     and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment     alternatives. Implant therapy is sometimes impossible, however, because of patient-related     risk factors or economic issues. In such cases therapy with an FDP requires extensive removal     of tooth structure to provide enough space for the restoration and to ensure mechanical     retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or     no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand     for minimal invasiveness and have been used clinically successfully. Sometimes, however,     patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since     the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed     while speaking or smiling or account for a colour change of the abutment teeth. Such patients     profit from an all-ceramic RBFDP. Today, the clinical performance of different all-ceramic     RBFDP designs has not yet been evaluated under randomized controlled conditions. The aim of     this pilot study is to calculate the sample size that allows us to accept the hypothesis that     the two designs tested are similar regarding their clinical performance with adequate     statistical power.   "
98478|NCT01997164|"     The primary objective of the study is to investigate the safety and tolerability of     intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular     degeneration (AMD), and separately in patients with diabetic macular edema (DME).   "
98439|NCT01997671|"     OBJECTIVE: To evaluate the impact of an intervention addressed to health professionals to     improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular     disease and reducing expenditure in this respect.      DESIGN: a cluster randomized clinical trial, not blind; Data were obtained from medical     records and other primary care databases.      SETTING: 279 primary health care teams in Catalonia (Spain), centers managed by Catalan     Health Institute (ICS)      SUBJECTS: Population from 35 to 74 years, free of cardiovascular disease, who have been     started on lipid-lowering therapy during 2 consecutive years of study.      INTERVENTION: Practitioners in the intervention group may have access, whenever they want and     through the computerized medical record program, to personalized information on their     assigned patients who have started treatment of cardiovascular primary prevention with     lipid-lowering. This information is updated monthly for 12 consecutive months.Information     will be presented in two different and complementary ways to each practitioner: asynchronous     information (the patient is not present when the practitioner receives the information) and     synchronous information (the patient is present when the practitioner receives the     information).      VARIABLES:        1. Primary Outcomes are:             -  Variable RETIRA: new lipid-lowering treatments initiated during the year prior to               the intervention, seen as inadequate and withdrawn during the intervention period.             -  Variable EVITA: New lipid-lowering treatments started during the intervention               period and considered as inadequate.        2. Secondary Outcomes are:             -  Variable COST: total cost of the inadequate new lipid-lowering treatments.             -  Variable RECORD: recording of the cardiovascular risk.      2.Other variables:        -  Principal: intervention/control group assignment of health professional.        -  Patient variables: demographic and clinical.        -  Professional variables: quality of care indicators.      STATISTICAL ANALYSIS: Descriptive analysis, agreggated at health professional level, will be     performed and subsequently multilevel analysis techniques will be used to estimate the effect     of intervention according to hierarchic data structure and, in particular, patient variables     effect.   "
98440|NCT01997658|"     Background: Reducing postoperative complications remains a dominant challenge for all     clinicians. By minimizing the incidence of adverse outcomes, health care costs and patient     recovery can be improved. A number of studies have documented that fewer postoperative     adverse events occur with the preoperative use of glucocorticoids (GC). Two small manuscripts     support the use of GC with particular reference to liver resection.      Major hepatectomy can be associated with numerous adverse outcomes (hemorrhage, bile leak,     liver failure, wound infection other infectious complications). This rate approaches 54% in     some trials. Additionally, the liver is responsible for numerous metabolic functions and     actively participates in the acute phase response via the generation of inflammatory     mediators and cytokines. Glucocorticoids play an important role in suppressing the     over-synthesis of pro-inflammatory cytokines and therefore may assist in reducing     postoperative complications. These pro-inflammatory cytokines recruit leukocytes at the site     of injury, leading to hepatic parenchymal cell damage. Decreasing pro-inflammatory cytokine     ratio may therefore reduce hepatic damage.      Methods: The investigators will complete a randomized controlled trial evaluating the     incidence of postoperative complications and overall hospital length of stay in adult     patients following preoperative vs. no administration of 500 mg of methylprednisolone (MP)     within 30 minutes of starting a hepatectomy. This trial will employ block randomization and     intention to treat protocols. Four HPB surgeons at University of Calgary will participate in     the trial with a planned inclusion of all patients scheduled to undergo hepatectomy in a     period of 2 years.      Analysis: Standard statistical analysis will include normally or near-normally distributed     variables reported as means and non-normally distributed variables as medians. Means will be     compared using the student's t test and medians using the Mann-Whitney U test. Differences in     proportions among categorical data will be assessed using Fischer's exact test. A p value <     0.05 will represent statistical significance for all comparisons.      Hypothesis: Preoperative GC administration will decrease the incidence of postoperative     complications and overall hospital length of stay following hepatectomy.      Potential Impact: Health care utilization and economics are an expanding area of importance.     Reducing post-hepatectomy complications are crucial to this end.   "
98441|NCT01997645|"     Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the     third and fourth decade of life. According to Parks classification fistulas have been divided     into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple     fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high     (transsphincteric) fistulas it may affect anal continence seriously.      Therefore sphincter preserving procedures should be preferred in these cases. Rectal     advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication     with high success rate in cryptoglandular fistulas. However, this technique is technically     demanding and results can be expert depended with wide spread of healing rates (24-100%) in     individual studies as referred in recent systematic review.      Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple     sphincter preserving technique. The success rate varies between 40-95% with low overall     incontinence rate (6%).      The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment     of high perianal fistulas.   "
98442|NCT01997632|"     The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that     only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that     contains the 3 serotypes of polio). This safety evaluation will be done in young adults.      If the study vaccine appears to be safe, it will be tested at a later stage in the target     group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the     purpose is to use the study vaccine in the future to protect young children against Polio     serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young     children to come to a complete eradication of Polio is needed. The standard use of Imovax to     protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio     vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has     been developed.      The duration of the study will be approximately 6 months. 120 subjects between 18 and 45     years of age will participate in Belgium.      During the study there will be 2 groups of subjects. Subjects will be assigned by chance to     one of these groups. One group will receive one single injection of the study vaccine m-IPV2     HD (which contains only serotype 2), the other group will receive one single injection of the     standard polio vaccine IPV, Imovax (which contains the 3 serotypes).      After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked     to come to the study centre one more time for the second visit (on Day 8, which is 7 days     after the first visit). They will also receive 2 follow-up phone calls for approximately one     month and 6 months after vaccination.   "
98443|NCT01997619|"     Complex ventral hernia repair is a significant surgical challenge with high frequencies of     both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in     2010 recommendations regarding grading and technique of repair, which we have followed since     November 2011.The purpose of the this study was to evaluate our results after biologic mesh     repair of complex hernias.   "
98479|NCT01997151|"     This program of research tested the effectiveness of an iPad delivered multiple behavior     intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It     was hypothesized that the intervention would reduce the number of health behavior risks     reported by pregnant women in the treatment group. The target behaviors of the intervention     are smoking cessation and relapse prevention, stress management, and fruit and vegetable     consumption.   "
98480|NCT01997138|"     This project investigates the relation between acute pain and local inflammation. Pain     reported by the patients for knee arthroscopy are compared with local changes in inflammatory     mediators by using microdialysis technique. Patients with moderate-to-severe pain are     included in a randomized placebo-controlled trial of anakinra given intra-articularly.   "
98444|NCT01997606|"     Product information:      Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected     for their ability to clean up house dust mite allergen along with other allergen types.      Study design:        -  Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers          will be compared to untreated, classical bedding covers (placebo).        -  Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the          subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months          (=period A) and, after a wash out period of 1 month, the untreated covers (set          B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will          first use the untreated set (set A=placebo) and, after a wash out period the Purotex          impregnated covers (set B=Purotex).        -  Randomized: The subjects will be randomly assigned to one of the 2 treatment arms.        -  Double blind: both the subjects and the investigators will not know to which treatment          arm the subjects are assigned.      Study hypothesis:      We want to investigate:        -  if there is a reduced concentration of HDM allergen in Purotex covers compared to          untreated covers in real life        -  if patients with allergic rhinitis to house dust mite use the Purotex covers, they          experience an improvement of their quality of life and sleep, and an improvement of          their allergic symptoms and global discomfort   "
98445|NCT01997593|"     The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of     ropivacaine in children undergoing laparoscopic surgery.   "
98446|NCT01997580|"     To explore electrophysiologic parameters and biomarkers predicting treatment response of     patients with major depressive disorder To explore electrophysiologic parameters and     biomarkers predicting suicide risk of patients with major depressive disorder   "
98447|NCT01997567|"     The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial,     whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with     ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total     30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day     elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores),     postoperative opiate consumption, and time to discharge from the postanesthesia care unit.     Differences between groups with respect to postoperative quality of life and functional     scores will also be evaluated.   "
98448|NCT01997554|"     The aim of this research project, which is realised with the partnership of the enterprise     Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an     earlier screening of hypothyroidism. A serum bank will be conserved in the Centre de     Biologie Sud (Groupement Hospitalier Lyon Sud).      The serum samples will be assayed locally for the usual medical support to patients and after     they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the new     diagnostic test. The results obtained from the two techniques will be compared.      The validation of this new TSH test represents a major advancement, since it could bring in     the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic     patients with subclinical hypothyroidism.   "
98449|NCT01997541|"     There will be a difference of the insertion depth between the types of the endotracheal tube.   "
98450|NCT01997528|"     Oxygenatuion and decarboxylation during different settings (steps of blood flow and sweep gas     flow) of extracorporeal gas exchange by ILA Activve using a jugular 22French double lumen     cannula are measured.   "
98451|NCT01997515|"     Laparoscopic surgery for gastric reduction is frequently associated with high levels of     postoperative pain. Postoperative pain is very often treated with opioids. However large     doses of opioids can result in respiratory depression with hypoxemia especially in high risk     patients with obstructive sleep apnea. since a large group of patients undergoing surgery for     gastric reduction surgery also have obstructive sleep apnea, it is expected that these     patients are also at high risk for postoperative respiratory depression and hypoxemia.      Intraoperative ketamine has been used as an effective multimodal agent to reduce     postoperative pain. However, ketamine alone has not been examined to improve postoperative     pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is     unknown if the use of intraoperative ketamine can lead to better overall quality of recovery     in the same patient population. In addition, ketamine has been shown to improve ventilation     but it remains to be determined if the intraoperative use of ketamine will result in less     postoperative hypoxemic events.      The main objective of the current investigation is to examine the effect of intraoperative     ketamine on postoperative quality of recovery after gastric reduction surgery. The     investigators hypothesize that subjects receiving ketamine will have a greater global quality     of recovery score than the ones receiving saline. The investigators also seek to determine if     intraoperative ketamine would decrease the incidence of postoperative hypoxemic events in the     same patient population.   "
98452|NCT01997502|"     This protocol is a request from Masimo to assist in the collection of data to be used to     further refine the accuracy of the monitor's algorithm.   "
98453|NCT01997489|"     Fabry disease is a recessively inherited disorder due to systemic storage of abnormal     metabolites (ceramide trihexocide, in particular) caused by lack of the lysosomal enzyme     α-galactosidase. Though X-linked, in patient series there are often equal numbers of males     (hemizygotes ) and females (heterozygotes, probably caused by a mutation in one allele and an     inactivation on the other allele in the X chromosomes), and many clinical features are     shared.      Abnormal storage in endothelial and smooth muscle cells explains morbidity, including a     shortened life expectancy. This is due to age dependent ischaemic manifestations that affect     heart, kidney and brain. Angiofibroma is an early cutaneous manifestation, and painful     acro-paresthesias express juvenile neuropathy.      Cornea verticillata is an almost obligate ophthalmic finding. The brown-yellow Bowman     membrane related corneal deposits and teleangiectatic conjunctival vessels are early     ophthalmic slit-lamp markers of the disorder; further there can be subtle lens opacities.     Fundus vessel tortuosity is observed in many patients, in particular of the retinal venules,     but best corrected visual acuity (BCVA) is usually normal.      After the introduction of enzyme substitution therapy in 2001, ophthalmic examinations were     scheduled as regular part of the general evaluation of the Fabry patients at Rigshospitalet,     Denmark. A 10-year ophthalmic state of arts was part of oral presentations at a Copenhagen     conference in December 2011. In contrast to the common occurrence of systemic vascular     sequels, only one patient in the series had suffered severe visual loss; this was unilateral     and occurred years before institution of the enzyme therapy. In 2013, however, another young     male presented a similar retinal event. Sporadic cases of visual loss are reported in the     literature, but in larger Fabry series ocular vascular catastrophes appear the exception to     the rule.      Following the introduction of enzyme substitution, we found it of interest to present our     nationwide Danish experience. We focused on retinal vessel morphology and the relation to     systemic morbidity.   "
98454|NCT01997476|"     The purpose of this study is, to develop a standard of care protocol using the combination of     EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate endoscopic     sessions). The desired outcome is to diagnose CP and to establish an acceptable protocol for     performing this combined technique. It is expected that combining these procedures will     eliminate redundant portions of the procedures, reduce repeat visits to the hospital, reduce     total recovery time for the patient, and will decrease the associated costs of separate     procedures. Chronic pancreatitis (CP) is an irreversible, disease in which the pancreas     becomes fibrotic ( thickened and scarred). Symptoms almost always include pain, and as the     pancreas becomes progressively more fibrosed (thickened), pancreatic hormonal function is     compromised with diarrhea and weight loss. However, while most physicians can readily     diagnose patients with severe CP, early CP or minimal-change CP is difficult to detect,     often due to the lack of radiologic findings, laboratory tests and classic symptoms. As a     result, clinicians are searching for diagnostic tools which will allow for earlier, accurate     detection of this disease, with the hope that appropriate therapy can be initiated before     extensive thickening and scarring of the pancreas occurs.      Diagnostic tools to evaluate the pancreas include Endoscopic Ultrasound (EUS),     hormone-stimulated endoscopic pancreatic function tests (ePFT) and Secretin stimulated     Endoscopic Pancreas Function Test (sPFT) using pancreatic fluid (containing bicarbonate)     obtained from the duodenum (the part of the intestine where the stomach opens into the small     bowel). EUS is increasingly being used as a diagnostic and treatment tool in pancreatic     disease. Currently, hormone-stimulated ePFT is considered the best way to diagnose chronic     pancreatitis (long-lasting inflammation and scarring of the pancreas), and removes the need     for biopsy or surgery. It is also sensitive in detecting mild disease.      These procedures are standard of care (the normal care you would receive) for the evaluation     of CP. The purpose of this study, is to develop a standard of care protocol using the     combination of EUS, ePFT, and sEUS during one endoscopic session, instead of three separate     endoscopic procedures.   "
98455|NCT01997463|"     The investigators hypothesize that school-based, direct supervision of daily controller     therapy will result in more effective asthma control, as assessed by the Asthma Control     Questionnaire than usual care. Additionally, as the result of enhanced asthma control and     resulting decrease in health care utilization, school-based, direct supervision of daily     controller therapy will result in lower cost per quality-adjusted life year (QALY) gained     than usual care.   "
98456|NCT01997450|"     This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live     attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza     Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.   "
98457|NCT01997437|"     The proposed protocol will involve the replacement of the trachea using a synthetic     bioengineered scaffold seeded with autologous mononuclear cells as an intraoperative solution     for patients with with benign and malignant laryngo-tracheal diseases or other terminal     conditions of the trachea.      Tracheal transplant is indicated as the only therapeutic alternative in cases where     instrumental, endoscopic and other evaluations show that the length of residual healthy     airways (about 6 cm or longer than 50% of the airway length) and the localization and     extension of the obstruction make it impossible to perform a surgical resection of the     pathological segment.      In addition to tracheal surgical transplant techniques, this protocol requires knowledge and     experience with autologous cell preparation as well as scaffold seeding procedures.   "
98458|NCT01997424|"     This study will evaluate the association of non-alcoholic fatty liver disease and diabetes     mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive     the following examination:        -  Transient Elastography and Controlled Attenuation Parameter using the FibroScan        -  blood examination including biochemical markers The statistically calculated sample size          needed is 340 patients.   "
98459|NCT01997411|"     The purpose of this study was to assess how glucagon administered as a puff into the nose     (AMG504-1) works in children and adolescents compared with commercially-available glucagon     given by injection. In addition, the safety and tolerability of glucagon given as a puff into     the nose was evaluated.   "
98460|NCT01997398|"     There is a growing trend in functional neurosurgery toward direct anatomical targeting for     deep brain stimulation (DBS). This study describes a method and reports the initial     experience placing DBS electrodes under general anesthesia without the use of microelectrode     recordings (MER), using a portable head CT scanner to verify accuracy intra-operatively.   "
98461|NCT01997385|"     The aim of this study is to assess the impact of adapted Automated Peritoneal Dialysis(APD)     sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill     volumes in comparison with conventional APD prescribed a standard continuous cycling     peritoneal dialysis on the efficacy of dialysis.   "
98462|NCT01997372|"     Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by     pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte     globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more     and excellent overall survival. However ,there are no clinical trials to illustrate the     response and complete remission rate with different doses of ATG.And there are no data     reported on children with SAA so far.   "
98463|NCT01997359|"     The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.     However more than half the patients who need HIV treatment are still not receiving     antiretroviral therapy (ART). This can lead to early death from AIDS. Additionally, many     patients start ART late after the HIV disease is very advanced. This results in high death     rates soon after starting ART. The factors that contribute to late ART initiation are still     unclear. This study will identify factors that help patients to enroll or prevent them from     enrolling into HIV care and starting ART on time. We will examine the characteristics of all     patients initiating ART at study sites. We will also look at potential risk factors among     patients who initiate ART late (cases) compared to patients who initiate earlier (controls)     at 6 HIV care and treatment clinics in Ethiopia. Data will be collected using 2 methods:        1. Face-to-face interviews with participants using questionnaires        2. Obtaining clinical data from the electronic patient-level database      Identifying factors that help patients to start or prevent them from starting ART on time     will help to direct interventions, programs and policies to reduce early death.   "
98481|NCT01997125|"     The purpose of this clinical study is to allow the investigation of the Neural Bridging     System for participants with tetraplegia to assess if the investigational device can     reanimate a paralyzed limb under voluntary control by the participant's thoughts.   "
98482|NCT01997112|"     The purpose of this study is to examine if chronic paracetamol dosing increases blood     pressure in patients with known high blood pressure.   "
98483|NCT01997099|"     The purpose of this study is to describe the home healthcare organization ambulatory infusion     pump programming workflow and the process that was followed to introduce the new CADD®-Solis     VIP System to each home healthcare organization or facility. In addition, this study will     characterize the overall clinician (Phase 1) and patient (Phase 2) ease of use and     satisfaction with the CADD®-Solis VIP System.   "
98464|NCT01997346|"     The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.     However more than half the patients who need HIV medicines are still not receiving this     antiretroviral therapy (ART), and this can lead to early death from AIDS. One of the problems     in this region is that patients start ART late, after the HIV disease is very advanced. This     results in high death rates soon after ART initiation. The way clinic-level factors, such as     the way services and referrals are organized, how referrals are regarded, counseling messages     and record-keeping, contribute to late ART initiation is unclear. As the second phase of a     3-phase NIH-sponsored project, this study will identify clinic-level enablers and barriers to     timely enrollment into HIV care and ART initiation. A cross-sectional qualitative study will     be conducted at 4 selected HIV care and treatment clinics and the health facilities in which     they are located in Ethiopia. Data will be collected using 4 methods:        1. Data abstraction        2. Key informant interviews with clinic personnel        3. Observation of post-test counseling sessions in the VCT clinic        4. Observation of provider-patient interactions in the care and treatment clinic          Identifying modiﬁable health facility-level predictors of late ART initiation will          facilitate implementation of interventions, programs and policies that will increase the          number of patients who enroll in HIV care and initiate ART early. Additionally, results          will inform the design of the third phase of the NIH-project referenced above.   "
98466|NCT01997320|"     Three months intervention study, investigating the effect of nutrient supplementation     (including 20g of milk protein) twice daily with or without additional heavy resistance     exercise three times weekly on muscle size, structure and function in 30 subjects at least 83     years of age.      Primary hypothesis is that the group conducting exercise improves muscle size, structure and     function.   "
98467|NCT01997307|"     The Ladies ACS study will investigate the relation between age at menopause and severity of     coronary artery disease in menopausal women with acute coronary syndromes and clinical     indication to coronary angiography.   "
98468|NCT01997294|"     Statins have been approved to benefit patients underwent percutaneous coronary intervention     (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential     Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI     treatment.   "
98469|NCT01997281|"     The aim of this study is to assess whether dietary fiber-enriched cereals effect on     postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or     glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2     diabetes mellitus.   "
98470|NCT01997268|"     The purpose of this study is to investigate the effects of SC401B (ethyl esters of     eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg     EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia     (triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). SC401B capsules also contain certain     surfactants that may aid in the absorption of EPA and DHA. Based on the results of     pharmacokinetic studies of healthy human subjects, unlike Lovaza®, EPA and DHA in SC401B are     bioavailable in both the fasted and fed states.      The protocol specified primary endpoint is the difference from the placebo group in the     percent change in TG concentration from baseline to week 12 for groups receiving 2, 4, or 6     capsules of SC401B per day. The protocol specified secondary endpoints include percent     changes from baseline to week 12 for total cholesterol (TC), LDL-cholesterol (LDL-C),     HDL-cholesterol (HDL-C), and non-HDL-cholesterol (non-HDL-C). Additional exploratory     variables include VLDL-cholesterol (VLDL-C), LDL-cholesterol particle size, apolipoprotein     (Apo) A1, Apo B, Apo C-III, and lipoprotein-associated phospholipase A2 (Lp-PLA2).      An additional objective is to determine the tolerability and safety of SC401B 2, 4 and 6     capsules per day for 12 weeks. Adverse events for SC401B and placebo including burping, fishy     taste, upset stomach, loose stools, stools with fishy smell or any other self-reported     observations will be evaluated. Additional safety measures will include changes in liver     enzymes (AST/ALT) occurring from baseline to week 12 for groups receiving 2, 4, and 6     capsules of SC401B and placebo.   "
98471|NCT01997255|"     Sturge Weber Syndrome (SWS) is a rare disease that affects the patient's brain and causes     benign (non-cancerous) tumors to grow in the brain. One of the symptoms of SWS is epilepsy.     People with epilepsy have seizures. Some patients may also have eye problems and a red mark     on their facial skin.      This study is being done to find out if the study drug, everolimus, is safe and has helpful     effects in patients with SWS who have seizures and are not responding to their current     anti-epileptic medication.      The study drug, everolimus (Afinitor®), is supplied by Novartis Pharmaceuticals Corporation.   "
98472|NCT01997242|"     The SAS registry will include any patient with previous coronary stenting undergoing any type     of surgery or operative endoscopic/endovascular procedure at the participating Centers. The     relevant clinical, procedural and outcome data (within index surgical admission and at 30     days) will be entered in a specifically designed electronic case record form (eCRF).   "
98473|NCT01997229|"     The purpose of this study is to determine if eculizumab is safe and effective for the     treatment of refractory generalized Myasthenia Gravis.   "
98474|NCT01997216|"     The purpose of this study was to compare binocular high contrast, high illumination (HC/HI)     visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX®     AQUA MULTIFOCAL contact lenses when worn for 9 hours.   "
98475|NCT01997203|"     Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon     (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects.     The purpose of this study is to determine the effect of vitamin D on liver affection in such     patients.   "
98476|NCT01997190|"     This is a phase I study of intrapleural AdV-tk therapy in patients with malignant pleural     effusion (MPE). The primary objective is to test the safety of intrapleural AdV-tk therapy.     Secondary objectives are to evaluate clinical efficacy and biologic activity   "
98477|NCT01997177|"     Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion     analysis. In order to develop a non-biased tool to monitor competence.   "
98729|NCT01993875|"     To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as     compared to matching placebo, when administered orally to subjects with chronic idiopathic     constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of     fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of     subjects.   "
98486|NCT01997060|"     In Denmark and the western world, there is an increasing prevalence of obesity probably due     to a combination of inadequate daily physical activity and a high energy intake. One approach     to achieve weight loss and change life style is to participate in an intensive supervised     prolonged life style modification course. The immediate effect is often positive, but over     time the overall effect is limited as the majority will not maintain weight loss and a     changed life style.      The purpose of this study is therefore to characterize the physiological factors that     determine/influence the capacity to maintain weight loss and a healthy lifestyle after a     prolonged lifestyle intervention.      We have the following research questions:        1. Are there physiological traits and characteristics that mediate better adherence to          lifestyle changes and weight loss?        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict          success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after          intervention?        3. How does gender and age influence the capacity to maintain the lifestyle induced          adaptation in muscle and adipose tissue and maintaining weight loss?      The study design is a longitudinal intervention and will be based on a lifestyle     intervention, as it is practiced in a real life setting at Ubberup folk high school.   "
98487|NCT01997047|"     Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children     under the age of 5 years, every year. This is more than the number of children dying from     AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for     managing serious respiratory diseases in children are 30 years old and are greatly in need of     updating. The successful establishment of useful clinical management criteria for children     with respiratory diseases will have benefits for children in low resource regions around the     world. The goals of the study are:        -  To determine if children with respiratory distress can be reliably diagnosed under          low-resource conditions.        -  To identify the clinical tests that best differentiate pneumonia from wheezy diseases.          These will be used to establish updated diagnostic criteria for common pediatric lung          diseases that broaden the current pneumonia algorithm by adding another for wheezy          illnesses.        -  The ultimate objective is to improve the management and outcome of acute respiratory          conditions in children.        -  Investigators also wish to test the efficacy of a locally developed cell phone oximeter          probe in a low resource setting.   "
98488|NCT01997034|"     In Denmark and the western world, there is an increasing prevalence of obesity probably due     to a combination of inadequate daily physical activity and a high energy intake. One approach     to achieve weight loss and change life style is to participate in an intensive supervised     prolonged life style modification course. The immediate effect is often positive, but over     time the overall effect is limited as the majority will not maintain weight loss and a     changed life style.      The purpose of this study is therefore to characterize the physiological factors that     determine/influence the capacity to maintain weight loss and a healthy lifestyle after a     prolonged lifestyle intervention.      The investigators have the following research questions:        1. Are there physiological traits and characteristics that mediate better adherence to          lifestyle changes and weight loss?        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict          success in maintaining weight loss and lifestyle changes?        3. How does gender and age influence the capacity to maintain the lifestyle induced          adaptation in muscle and adipose tissue and maintaining weight loss?      The study design is cross-sectional and will be based on a lifestyle intervention, as it is     practiced in a real life setting at Ubberup folk high school. The investigators will recruit     former participants of this lifestyle style intervention. 50 % who maintained a weight loss     and a healthy life style and 50 % who did not.   "
98489|NCT01997021|"     Increasing physical activity in older adults has important implications for treating obesity     related metabolic conditions, however the interaction of aging- and obesity-related declines     in physical function may make adding structured exercise particularly challenging for this     group. Given these challenges, an alternative prescription to traditional structured     exercise, may be short bouts of intermittent walking scattered throughout the day - this may     be an effective strategy to increase physical activity, reduce sedentary behavior, and     improve glycemic control in overweight/obese older adults. The purpose of this project is to     determine how interrupting sedentary time with short bouts of moderate intensity walking     affects important metabolic outcomes in older, overweight adults. It would also be of     interest to compare the effects of short, frequent interruptions in sedentary behavior to a     traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes     (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims     of the proposed research are to 1) Determine the effect of performing short bouts of     moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to     uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of     interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m     walk (CW)) on metabolism.      The investigators hypothesize that interrupting sedentary time with intermittent walking will     improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as     effective at improving metabolism as a single continuous 30 min walk.   "
98490|NCT01997008|"     This is a feasibility/pilot test of a set of positive affect skills provided online to HIV     positive people with elevated depressive symptoms - a Center for Epidemiological Studies     Depression Scale D (CES-D) score > 10. The investigators will test the feasibility of     recruitment, retention and acceptability of these skills in an online delivery format,     determine feasibility and acceptability of daily emotion assessments via text messaging and     assess efficacy of these skills for improving psychological well-being this population.   "
98502|NCT01996852|"     This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer.     144 patients and partners will participate in the study. The purpose of this study is to test     a new treatment that combines a cognitive-behavioral intervention with medication and a     vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic     elements that enhance compliance with medical treatment and increase sexual activity through     enhancement of the sensual pleasure of sex and partner support.   "
98503|NCT01996839|"     The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate     ophthalmic gel   "
98492|NCT01996982|"     This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of     a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at     University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The     proposed research on human subjects will provide data that will be used to improve a     specialized human heat transfer technique/device. By stimulating specialized blood vessels     (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase     local blood flow and thus greatly increase the potential for effective heat transfer between     the environment and body.      The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a     practical, safe, and effective method to raise or lower body temperature in critically ill     patients.   "
98493|NCT01996969|"     Regorafenib is a valuable treatment option for metastatic colorectal cancer patients who have     progressed after prior standard treatments. Prior progression-free survival data suggest that     there could be a distinct subgroup of patients that may benefit from regorafenib. The aim of     this study is to identify predictive biomarker of regorafenib in terms of its efficacy.   "
98494|NCT01996956|"     The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume     variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac     surgery.   "
98495|NCT01996943|"     Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it     has been associated with ethanol use. Understanding how ethanol affects the electrical     properties of the heart and induces AF has important public health implications. The     objective of this research is to investigate the mechanistic relationship between ethanol and     atrial fibrillation in humans by performing a placebo controlled study looking at the     electrical properties of the heart in patients receiving intravenous ethanol or placebo. The     investigators hypothesize that ethanol increases the susceptibility of human myocardium to     atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute     setting.   "
98496|NCT01996930|"     Kidney failure is a devastating illness requiring treatment with dialysis or transplantation     to preserve life. Individuals unable to have transplants are managed by peritoneal dialysis     (PD)or haemodialysis (HD). PD involves the placement of a soft, flexible plastic tube     (catheter) into the abdomen, allowing dialysis fluid to be drained in and out of the     peritoneal cavity. This catheter exits from a hole in the abdomen and occasionally patients     can have complications at this exit site. One possible complication is over-granulation.     Over-granulation occurs as the wound attempts to heal and the skin around the exit site     becomes red,'wet','bumpy' and stands 'proud' of the surrounding skin. An over-granulating     exit site can lead to discomfort, pain, bleeding and harbour infection. More serious     complications include dialysis failure, sepsis and death. There are several ways to treat     over-granulation but there is limited research evidence to demonstrate which treatment is     best. The study aims to compare current standard treatment which involves the application of     silver nitrate by qualified nursing staff to chemically burn the tissue away, with an     alternative treatment which involves the application of steroid impregnated tape to the area     of over-granulating tissue by the patient themselves.   "
98497|NCT01996917|"     This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with     subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the     final skin layer of one breast will be closed with subcuticular suture while the other breast     will be closed with Prineo™. The treatment will be randomized to left or right breast.     Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™     group, with each patient serving as her own control. For this study, the resident will close     one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this     study of incision closure under conditions as similar to normal conditions of closure.   "
98498|NCT01996904|"     The purpose of this study was to report actual percentage of subscapularis tear in     concomitant with supraspinatus tendon tear (with or without infraspinatus tear) and     investigate the amount of contribution of subscapularis repair as to the outcome of whole     rotator cuff repair in terms of its clinical and radiologic aspects.   "
98499|NCT01996891|"     The purpose of this study is to evaluate the effects of a diet that is low in glycemic load     and abundant in fiber, fruits, vegetables, legumes and omega-3 fatty acids     (anti-inflammatory diet) on pulmonary function in pediatric patients with asthma. The     primary endpoint will be change in forced expiratory volume in one second in response to the     diet intervention. Secondary outcomes will include additional spirometry measures, fraction     of exhaled nitric oxide, and assessment of symptomatic asthma control. In addition, we will     identify potential physiological mechanisms relating diet with lung function, including     changes in systemic inflammation, insulin sensitivity, and intestinal microbiome composition.   "
98500|NCT01996878|"     To observe and analyze the correlation between Single Nucleotide polymorphisms (SNPs) and the     incidence of Parkinson's disease in Taiwanese.   "
98504|NCT01996826|"     The goal of this study is to investigate whether using bevacizumab (Avastin®) is both safe     and effective at decreasing the likelihood of a high-risk corneal graft rejection. Patients     who are high-risk for rejection have blood vessels growing from the white of the eye into     the cornea (clear, front region of the eye). The medication is used at the time of surgery     and in the weeks following surgery. Participants have a 50/50 chance at receiving the active     study medication or a placebo medication.   "
98505|NCT01996813|"     Shoulder arthroscopy is one of the most commonly performed orthopaedic procedures and it is     often done with the patient in the upright, or beach chair position (BCP).      There have been multiple reported complications associated with the BCP, including cerebral     ischemia, loss of vision, ophthalmoplegia, stroke, and even death. It has been reported that     patients with a body mass index (BMI) of 34 or greater are as much as 12 times more likely to     experience cerebral desaturation events (CDEs) compared to non-obese patients. CDEs in the     upright position are hypothesized to be partially related to reduced cardiac preload due to     venous pooling in the lower extremities which is exaggerated in obese patients. This     prospective observational study aims to determine if the use of compression stockings in     obese patients undergoing shoulder arthroscopy in the BCP can reduce the incidence,     frequency, or magnitude of CDEs experienced by the patient. We predict that compression hose     will help to reduce cerebral desaturation events.   "
98506|NCT01996800|"     This study explores the effectiveness of chiropractic and neuromuscular reeducation as     complementary and alternative medicine treatment approaches for autism. Our investigation     maintains the following three hypotheses:        1. Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in          children.        2. Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will          reduce the presentation of autistic symptoms in children.        3. The presentation of autistic symptoms in children will significantly differ between the          treatment groups of spinal manipulative therapy and spinal manipulative therapy in          unification with neuromuscular reeducation.   "
98507|NCT01996787|"     The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti     Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals Limited)     by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.)      Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens     maintenance, care and storage.   "
98508|NCT01996774|"     Many authors propose the strict avoidance of allergenic food as the only treatment for     children known to be allergic to certain food. However, it has been observed an increase of     the frequency and severity of the allergic accidents in these children in the long term.     Other teams have suggested treating these allergies (in particular peanut allergies) by     controlled and progressive reintroduction of the allergenic food. A good tolerance and a     prevention of allergic reactions consecutive to the ingestion of the same allergenic food     were observed. The immunological mechanisms of this type of treatment are not well known.      A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg     allergies after this kind of treatment. Certain experiments realized in mice models testing     the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ ,     CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading     to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating     allergies by the reintroduction of the allergenic food, the immunological mechanism of     acquisition of tolerance is associated to variations in populations of lymphocytes and in the     activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied     in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children     without antecedents of allergy or familiar atopy.   "
98509|NCT01996761|"     This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized,     double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute     stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the     efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio     of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of     FMA at baseline) in patients with subacute stroke.   "
98510|NCT01996748|"     The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment     of otic eczema.   "
98511|NCT01996735|"     Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the     extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular     uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can     contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in     patients with an acute myocardial infarction. In the current research proposal, we aim to     investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by     ENT inhibition.   "
98512|NCT01996709|"     The purpose of this study is to assess improvement of palpebral roughness and associated     symptoms with 3 months use of Clear Care®.   "
98513|NCT01996696|"     In current clinical practice, an acceptable standard treatment for locally advanced prostate     cancer is radiation therapy in combination with hormone therapy (called Treatment B or Group     B in this study). However, despite our best treatments, there is a risk that the prostate     cancer may eventually return. As well, the hormonal therapy that is given to treat the     prostate cancer is known to cause some harmful effects, with some patients using the hormones     gaining weight, developing diabetes, having increased cholesterol levels, having increased     blood pressure, and/or heart problems.      This study is looking at whether Metformin, a drug that is commonly used to treat diabetes,     can prevent patients from developing some of the harmful effects of the hormonal therapy. In     treating diabetes, Metformin is known to decrease patients' sugar levels and also prevents     patients from gaining weight, decreases their cholesterol levels, decreases the number of     heart problems and allows patients to live longer. As a result, the researchers in this study     are hopeful that Metformin will also be beneficial for men with prostate cancer on hormonal     therapy by preventing them from developing these problems.   "
98514|NCT01996683|"     safety and efficacy of different iron chelation therapy in transfusion dependent     beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.   "
98515|NCT01996670|"     We hypothesis a period of early NCPAP before surfactant treatment is effective for treating     RDS and preventing BPD in very premature infants.   "
98516|NCT01996657|"     The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve     replacements is still controversial due to the different risk profiles of thrombophilia and     bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or     prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.      This study was to evaluate whether elevated D-dimer levels could help to determine the     intensity of oral anticoagulation in patients with mechanical heart valve prostheses.   "
98517|NCT01996644|"     This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication)     augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The     investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be     reduced more in the DCS relative to placebo condition (c) participants in the DCS condition     will have a greater increase in Body Mass Index.   "
98518|NCT01996631|"     Oxidative stress(OS), inflammation, and endocrine-disrupting chemicals(EDC) were all thought     as important markers that will impact on female reproductive function. However, the     cause-result correlations between above parameters were still unclear. Investigator plans to     design a study to evaluate the OS, inflammation, and EDC and their impact on the menstrual     cycle and reproductive hormone in Taiwanese women. Ferritin is a ubiquitous intracellular     protein that is essential for the regulation of iron homeostasis. Serum ferritin level is a     widely available clinical biomarker used to estimate body iron status. Iron is a strong     pro-oxidant, and high body iron levels are associated with an increased level of OS that may     elevate the risk of type 2 diabetes. Mildly elevated body iron stores are associated with     statistically significant elevations in glucose homeostasis indexes. Furthermore, patients     with elevated iron stores present not only insulin resistance but also metabolic alterations     that put them at increased risk of cardiovascular disease. Increased serum ferritin levels     have been found in women with Polycystic Ovary Syndrome(PCOS). Serum ferritin were highly     correlated with menstrual cycle and androgens level in women. Homocysteine, a     sulfur-containing amino acid formed during the metabolism of methionine, exerts cytotoxic     effects on the vascular endothelium. Hyperhomocysteinemia has been established as an     independent risk factor for thrombosis and cardiovascular disease, and it may partially     account for the increased risk of cardiovascular disease associated with insulin resistance.     Elevated total plasma homocysteine levels have been established as an independent risk factor     for thrombosis and cardiovascular disease. Studies related to homocysteine and PCOS have     reported inconsistent results.      Chronic low-grade inflammation has emerged as a key contributor to the pathogenesis of PCOS     and obesity. A dietary trigger such as glucose is capable of inciting OS and an inflammatory     response from mononuclear cells of women with PCOS, and this phenomenon is independent of     obesity. The correlation between inflammatory markers and reproductive endocrine disturbance     and consequent complications should be important.Both OS and EDC had been associated with     PCOS.      BPA, one of EDC, is an environmental estrogen used in the synthesis of plastics, is a     high-volume production chemical with widespread human exposure. BPA was been reported in     several female reproductive disturbance. However, the pathological pathway of BPA impact on     female reproductive system had not been well-understood. Reactive oxygen species have a role     in the modulation of gamete quality and gamete interaction. Persistent and elevated     generation of ROS leads to a disturbance of redox potential that in turn causes OS. The first     part of our study is aim to evaluate the OS impact on the biochemical parameters in women     with PCOS; the secondary part of our study is to investigate the BPA on the clinical and     biochemical of women with PCOS; finally, investigator plans to test the hypothesis that BPA     might increase OS and then elevated ROS in women with menstrual disturbance, furthermore, the     role of OS and BPA impact on insulin resistance and metabolic disturbance will be also     investigated.      OS, inflammation, and EDCs are all important factors impact on the reproductive competence in     women. To clarify above problems are critical importance. Investigator then conduct this     study to demonstrate those problems. Study and control cases will be included. Serum total     oxidant status, inflammatory biomarkers, total antioxidant status, BPA, and     clinical/biochemical parameters will be obtained for all cases. OS and BPA will be evaluated     with all clinical/biochemical parameters for all subjects.   "
98519|NCT01996618|"     Investigate whether ranolazine, a novel anti-anginal agent with antiarrhythmic properties,     has a role in the management of symptomatic ventricular premature beats.   "
98520|NCT01996605|"     The purpose of this study is to determine the effect of intrathecal oxytocin on areas and     intensity of hyperalgesia and allodynia induced by topical capsaicin.   "
98521|NCT01996592|"     Many factors influence the development of persistent pain after CS (chronic pain) as well as     post-partum depression. We are attempting to use trajectory pain methods in an attempt to     identify those at risk for the development of persistent pain post delivery using a daily     method of contact for the determination of pain scores. Assessments are also done evaluating     satisfaction of pain management and maternal/infant bonding opportunities. Physical activity     is monitored by subject's wearing a Fitbit with correlation being done with pain scores     obtained over 60 days postop with eligible subjects..   "
98522|NCT01996579|"     Lactoferrin is a protein that is a component of the immune system. It has many properties     that could make it the ideal agent for the prevention of hospital-acquired infections.     Lactoferrin has antibacterial properties (is able to kill or stop the growth of disease     causing bacteria and fungal organisms), it improves immune function, and can increase the     growth of beneficial bacteria in the bowel. Lactoferrin has been approved by Health Canada as     a Natural Health product and is sold in health food stores as a supplement. However, given     the potential beneficial effects of Lactoferrin, it requires further study as to its effects     in acutely and seriously ill patients. One potential use which has not been studied is for     the prevention of infections in critically adult ill patients. The aim of this study is to     determine the utility of Lactoferrin in this patient population.      The Lactoferrin that the investigators will be using in this study is extracted from cow's     milk, where it naturally occurs. Cow lactoferrin has similar properties as that normally     produced in the human body. This study is being conducted to determine how well a solution of     Lactoferrin given orally and through a feeding tube helps to prevent infections and     inflammation in critically ill patients in addition to usual care and other measures that are     known to be partially effective for the prevention of infections.   "
98523|NCT01996566|"     Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic     acids will be explored. Prior work indicates that there may be a learning effect in measuring     detection thresholds for free fatty acids. This study is designed to determine the number of     visits necessary to attenuate this learning effect and also to test whether this effect     continues across different types of fatty acids or is specific to each fatty acid. This will     aid in understanding how many visits are required to obtain reliable data and if less     expensive fatty acids can be used to attenuate learning before testing thresholds for more     expensive fatty acids.   "
98524|NCT01996553|"     The purpose of this study is to establish the rate of radial artery occlusion post     transradial cardiac catheterization through different modalities.      The study hypothesis is that specialized imaging can provide specific information to help     identify hand complications after cardiac catheterization through the wrist.   "
98525|NCT01996540|"     Title: The role of early systematic best palliative care versus on request palliative care     consultation during standard oncologic treatment for patients with advanced gastric or     pancreatic cancers: a randomized, controlled, multicenter trial.      Description of Study Treatment:        1. Interventional arm Patients will receive standard oncologic care and will be assigned to          early systematic best palliative care. They will meet a member of the palliative care          team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative          care team member every 2 weeks until death. Patients assigned to this experimental arm          will be evaluated if the total of palliative care visits between T0 (day of enrollment)          and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by          the General guidelines for palliative care: specific attention will be paid to assessing          physical and psychosocial symptoms, establishing goals of care, assisting decision          making regarding treatment, and coordinating care on the basis of the individual needs          of the patients.           The doctor expert in palliative care, with regular visits in the experimental arm, must          be a physician dedicated full time to palliative care, that can directly prescribe drugs          and other interventions, and with a particular attention to physical, psychological, and          spiritual needs.           Palliative care doctor must have the possibility to decide about organizational          arrangements.           He has to perform the palliative care visit according to Temel indications.        2. Standard arm Patients will receive standard oncologic care and will be assigned to on          request palliative care consultation. They will be not scheduled to meet with the          palliative care service unless a meeting will be requested by the patients, the family,          or the oncologist. After the time of evaluation (T1) patients will be followed by the          palliative care services as needed.      Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ±     3.      Patients will receive standard antineoplastic treatment in both arms of the study according     to best clinical practice in each participating centre.   "
98526|NCT01996527|"     This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in     measuring treatment response in patients with high-grade glioma. New diagnostic procedures,     such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in     measuring treatment response in patients receiving treatment for high-grade gliomas.   "
98527|NCT01996514|"     We hypothesized that FA in a TV program watched during a meal, would block satiety responses     to pre-meal energy consumption and delay satiation in OW/OB but not in NW boys and girls.     Food intake was measured at 30 min following a glucose (1 g of glucose/kg body weight) or     sweetened noncaloric beverage with or without the presence of food advertisements. Subjective     appetite will be measured as well.   "
98528|NCT01996501|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets     (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a     washout period during fed study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
98529|NCT01996488|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets     (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a     washout period during fasted study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
98530|NCT01996475|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd.,     India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest     Laboratories Inc, USA] . Dosing periods were separated by a washout period during fed study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
98531|NCT01996462|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd.,     India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest     Laboratories Inc, USA] . Dosing periods were separated by a washout period during fasted     study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
98532|NCT01996449|"     Hypertensive patients often show an exaggerated rise in blood pressure during exercise     through overactivity of the exercise pressor reflex. An increasing body of evidence suggests     a role for aldosterone in augmenting the exercise pressor reflex in hypertensive humans. We     hypothesize that this effect of aldosterone is mediated by its direct action on the central     nervous system and that administration of mineralocorticoid receptor antagonists constitute     an effective treatment for EPR overactivity in hypertension, independent of reductions in     resting BP.   "
98533|NCT01996436|"     The primary objective of the study is to determine the optimal intra-arterial drug treatment     regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal     subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days     post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.      We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is     more efficacious than single agent treatment cerebral vasospasm therapy.      All procedures done as a part of this study are standard hospital care procedures done to     treat cerebral vasospasm and all drugs to be used are FDA approved.   "
98534|NCT01996423|"     The purpose of this study is to determine whether oral vitamin D supplementation improves the     clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate     the effects of vitamin D supplementation on several key aspects of the immune system of     children with atopic dermatitis.   "
98535|NCT01996410|"     The goal of this study is to determine if acupuncture improves multiple symptoms associated     with chemotherapy on the MD Anderson Symptom Inventory (MDASI): nausea, vomiting, fatigue,     anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and     peripheral neuropathy (see statistical section). The investigators hypothesis is that     acupuncture will result in lower MDASI scores over the course of chemotherapy for the     acupuncture group vs. control group.   "
98536|NCT01996397|"     Exploratory, prospective, interventional, non-randomized single-center research study to     compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG     to augmentation of left ventricular contractility (LV dP/dt max) at different pacing     configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will     be compared to pre operative cardiac ultrasound and MRI metrics.   "
98537|NCT01996384|"     The investigators research project is a randomized, controlled, single-blinded, feasibility     pilot study. The investigators will study the feasibility of a novel treatment for women with     Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a     numbing agent and common first treatment for this disorder. Acupuncture is a treatment     commonly used for other pain disorders. The investigators will compare two types of     acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine     cream. Researchers want to determine if acupuncture is acceptable and convenient to women     with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream     will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.   "
98538|NCT01996371|"     The purpose of this study is to compare the healing of the patients spine at 24-months     following surgery and screw placement among 3 groups. The doctor will also compare clinical     outcomes and the immediate and delayed medical and surgical complications among the 3 study     groups. The goal of this study is to determine if treating patients with one of the 3 groups     is better than the others.   "
98539|NCT01996358|"     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as     rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by     sugammadex. The investigators compare the intubating conditions, incidence of postoperative     myalgia (POM) as well as patient satisfaction for these two muscle relaxants.   "
98540|NCT01996345|"     The purpose of this study is to perform a large multi-center randomized trial comparing the     role of vaginal pessary versus expectant management in women with placenta previa between     22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Secondary outcomes will     assess duration of antepartum admission, total blood loss, gestational age at delivery, type     of cesarean delivery, and a composite neonatal outcome. The hypothesis is that the use of a     vaginal pessary in patients presenting with placenta previa between 22-32 weeks will decrease     delivery prior to 36 weeks as compared to expectantly managing these patients.   "
98541|NCT01996332|"     This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced     NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated     time on study treatment is 3-12 months.   "
98542|NCT01996319|"     This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on     pulmonary function and average physical activity levels in patients with moderate to severe     Chronic Obstructive Pulmonary Disease (COPD).   "
98543|NCT01996306|"     The primary purpose of this study is to determine the non-inferiority of overall survival     XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as     Second-line therapy in Patient with Metastatic Colorectal Cancer.   "
98544|NCT01996293|"     This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during     pregnancy for women with Bipolar Disorder. The investigators predict that the concentration     of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum.     Because the concentration of the medication is likely to decrease during pregnancy, it is     important for doctors to know how much they should increase a patient's dose in order to     prevent worsening of Bipolar symptoms. In this study, the investigators will ask that     participants complete up to five overnight visits to our clinical research unit where their     blood will be drawn every couple of hours, through an IV catheter, to measure how the     concentration of lamotrigine (Lamictal) changes over time. Participants will be compensated     for their time.   "
98556|NCT01996137|"     An exploratory clinical study on a Variable Speed and Sensing Treadmill system(VASST) for     hemiparetic gait rehabilitation after stroke.      Building upon the positive results of VASST I conducted in 2012, VASST II will be an open     label pilot trial of 11 subjects screened for eligibility by TTSH medical and rehabilitation     team Study hypotheses : Training on VASST may result in a gain of +40% - 50% for distance     walked and +10-20% of gait speed compared to baseline and response rate of 85% and serious     adverse event rate of <10%.   "
98545|NCT01996280|"     Culturally-tailored empirically-based interventions are needed because Latinos suffer a     greater burden of alcohol-related health disparities and negative social consequences     compared to other racial/ethnic groups, are less likely to initiate and to remain in     treatment, and are more likely to live in communities with a high density of alcohol outlets.     Pilot data from the PI's (New Investigator) K award (AA014905), which will serve as the basis     for the current proposed larger-scale study, demonstrated that culturally tailored     motivational interviewing (CTMI) outperformed motivational interviewing (MI) that was not     tailored to the needs of Latino heavy drinkers. The public health impact of this study will     be to develop a program of early screening and brief intervention to reduce hazardous     drinking among Latinos, to minimize the burden of illness and social consequences that     disproportionately affect Latino communities.   "
98546|NCT01996267|"     This study compares two schedules of upfront chemotherapy in HER positive breast cancer.   "
98547|NCT01996254|"     The purpose of this study is to determine if electrical stimulation (small levels of     electricity) can safely and effectively reduce post-amputation pain. This study involves a     device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to     nerves in the residual limb. The SPRINT System includes a small wire (called a lead) that     is placed through the skin in the upper leg. It also includes a device worn on the body that     delivers stimulation (called the SPRINT Stimulator).   "
98548|NCT01996241|"     This cluster Randomised Control Trial is evaluating an intervention to support adolescent     girls from marginalised communities in northern Karnataka State, South India to complete     secondary school, thereby reducing their vulnerability to HIV infection from early marriage     and entry into sex work at young ages. The intervention will test innovations to address both     supply and demand side barriers to girls' completion of secondary school, and will have     long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV.      School-based constraints will be addressed by improving academic outcomes through teacher     training and academic support to students; addressing gender-related and skill-based gaps     among teachers; training of local female teachers; and increasing the content knowledge of     secondary school teachers. Demand side barriers will be addressed by reducing economic     pressures that households face to withdraw girls' from school; building appreciation and     value of girls' education; building family and community accountability for school     attendance; creating safe spaces for girls and strengthening their agency; and engaging boys     in promoting and supporting girls' education.      Primary stakeholders will include teachers and students, especially adolescent girls in the     school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will     include school development and management committees (SDMCs), families, boys and the     communities that are served by the schools. 80 village clusters (40 intervention; 40 control)     were randomly selected from 125 village clusters in Bagalkot and Bijapur districts. The     intervention will be implemented with village communities and high schools in 40 village     clusters in Bagalkot and Bijapur districts. The intervention will be implemented in     collaboration with the Department of State Educational Research and Training (DSERT),     Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE),     Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.   "
98549|NCT01996228|"     Type 1 diabetes (T1D) is an autoimmune disease that usually occurs in children and reduces     their pancreatic islet beta cells and thereby limits insulin production. Millions of     individuals worldwide have T1D, and the number of children with diagnosed or undiagnosed T1D     is increasing annually. Insulin supplementation is not a cure. It does not halt the     persistent autoimmune response, nor can it reliably prevent devastating complications such as     neuronal and cardiovascular diseases, blindness, and kidney failure. A true cure has proven     elusive despite intensive research pressure over the past 25 years. Notably, Dr.Zhao and his     team have successfully developed a groundbreaking technology Stem Cell Educator therapy (Zhao     Y, et al.BMC Medicine 2011, 2012). To date, clinical trials in adult patients have     demonstrated the safety and efficacy of Stem Cell Educator therapy for the treatment of T1D     and other autoimmune-associated diseases. Here, the investigators will evaluate the safety     and efficacy of Stem Cell Educator therapy in children with type 1 diabetes.   "
98550|NCT01996215|"     This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients     with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function.     The study team will assess whether the brain signatures associated with specific cognitive     deficits differ in older adults with and without AMD.   "
98551|NCT01996202|"     This is a pilot study assessing the safety of the combination of ipilimumab administered     concurrently with radiotherapy for patients with locally advanced or unresectable melanoma     and patients at high risk for recurrence after resection.   "
98552|NCT01996189|"     The primary objective is to compare the difference in the pain score in radial arterial     puncture using the insulin needle versus the standard 23G hypodermic needle.   "
98553|NCT01996176|"     The purpose of the study is to test an intervention aiming to reduce sitting time during work     hours among office workers.      Expectations according to outcome measures: Sitting time reduced by 1 hour pr. day (primary).     Number of prolonged periods reduced by 1 pr. day (primary). Number of breaks increased by 3     pr. day (primary). 20 % of participants report a reduction of musculoskeletal pain     (secondary). A reduction in waist circumference of 1 cm (secondary). A reduction of 0.5 % in     bodyfat (secondary).   "
98554|NCT01996163|"     Postoperative pain is a major concern in routine management of children admitted to pediatric     intensive care treatment. There are significant negative physiological and psychological     ramifications of postoperative pain such as impairment of cardiac function due to     tachycardia, restlessness in an intubated patient requiring increase dosage of sedative and     paralytic drugs and reduced patient cooperation in the healing process.      The main body of evidence dealing with gender differences in pain perception and treatment     stems from studies in the adult and adolescent population as the gonadal hormones have a     central role in the way one experiences pain The hypothesis of this study is that there is a     difference in the perception of pain, the amount of analgesia used and the response to pain     medication between male and female infants undergoing craniosynostosis repair or untethering     of cord.   "
98555|NCT01996150|"     This is pilot, mechanistic study to address whether bleach baths given to adult subjects with     atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus, will     significantly alter their skin microbiome and in so doing improve their skin barrier,     diminish expression of inflammatory proteins in the skin and improve itch. To answer these     questions the investigators will perform a 3-month, pilot, investigator-initiated,     single-center, open-label clinical study. This study will allow us to test the following     hypothesis: 1) that bleach baths will normalize skin barrier function, 2) that bleach baths     will diminish the local inflammatory response in the skin, and 3) that bleach baths will     improve validated measures of itch (also called pruritus).   "
98730|NCT01993862|"     The purpose of this study is to determine whether it is safe to send patients home from the     hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.   "
98557|NCT01996124|"     Chronic Obstructive Pulmonary disease (COPD) is one of the major clinical entities that     causes thousands of deaths every year all over the world and weights a lot on the health care     system of every country in terms of direct and indirect costs. The physiopathological     modifications that characterise COPD are represented by irreversible (sometimes partially     reversible) airflow obstruction, and bronchiolar inflammation. Lungs that develop emphysema     lack of elastic recoil and imply increased resistances and airflow obstruction due to loss of     lung parenchyma and supporting elastic structures. All these modifications produce air     trapping and so lung hyperinflation. The latter is precisely the cause of the symptoms and     particularly dyspnoea which is often heavily perceived by COPD patients and that drives to     the limitation of daily activities. Lung hyperinflation and the other alterations that occur     in COPD imply gas retention and increase in pulmonary vascular resistances. Considering that     the rib cage has limited elastic properties, the effects of gas trapping and lung parenchymal     damage on mediastinum and particularly on heart mechanics is indisputable. Together with     alveolar hypoxia, lung hyperinflation is responsible for the development, as the disease     progresses, of the cor pulmonale. Tha latter causes pulmonary hypertension and increased     mechanic load during right heart chambers contraction and relaxation. Those alterations may     effect left heart chambers too.      Airflow obstruction in COPD is usually treated by inhaled bronchodilators and     corticosteroids. The main and most used bronchodilators are represented by beta 2 agonists     (short, long and ultra-long acting) and anticholinergic inhalatory drugs, which can be also     short, long and ultra long acting. Among ultra long acting beta 2 agonists, indacaterol is     characterised by quick onset of action (5 minutes), and guarantees an effective     bronchodilation duration of 24 hours. It is also known that it has an important effect on     reducing lung hyperinflation decreasing residual volume and consequently allowing an increase     of inspiratory capacity. The purpose of our study is to evaluate the effects of indacaterol     on lung hyperinflation in COPD subjects of any stage and with lung air trapping, and the     consequent potential effects on heart performance evaluated by cardiac trans thoracic echo     color doppler.   "
98558|NCT01996111|"     This is a prospective, controlled, randomized, blinded and comparative, single-center     clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis     symptoms that have received standard of care versus treatment with differing amounts of     injectable dehydrated human amnion/chorion membrane micrografts(dHACM).   "
98559|NCT01996098|"     The purpose of this study is studying icotinib following chemotherapy to see how well it     works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC     harboring EGFR mutation.   "
98560|NCT01996085|"     Arterial hypertension (AH) is an important clinical social and economic problem. In the     pathogenesis of AH increased BP is a result of complex mechanisms i. e. fluid retention,     increased vascular resistance and hyperkinetic heart function. Impedance cardiography (ICG)     is a simple and safe, non-invasive method of hemodynamic monitoring which allows simultaneous     assessment of i. e. BP, cardiac index, heart rate, the fluid content in the chest and     systemic vascular resistance.      The detailed effect of treatment based on ICG has not been evaluated so far in the long-term     observation and for other clinically relevant parameters, such as central blood pressure,     left ventricular hypertrophy, metabolic disturbances, parameters of antioxidative-oxidative     balance and endothelial function. Therefore, the following main objectives of the study were     defined:        -  Evaluation of usefulness of impedance cardiography in optimizing treatment of patients          with hypertension in the area of reduction and control of blood pressure, hemodynamic          parameters, biochemical markers and quality of life.        -  Evaluation of complex pathophysiological mechanisms associated with hypertension          including hemodynamic, anthropometric, psychological and biochemical parameters as well          as the effect of antihypertensive treatment on these phenomena.      The study will be randomized (1:1), prospective and controlled in parallel with conventional     treatment. The subjects will be divided into groups according to the pre-established random     order:        1. empiric group (GE), in which treatment choice will be based on clinical data and current          guidelines        2. hemodynamic group (HD), in which treatment choice will be based on clinical data and          current guidelines considering hemodynamic parameters established with ICG method.      All patients will undergo a detailed examination three times: before treatment, then after 3     and 12 months of treatment.      The authors expect that the study will consolidate the importance of ICG in the diagnosis of     patients with AH. Simultaneous multiparametric evaluation of the subjects guarantees a unique     and innovative results which can enhance our knowledge in pathophysiology of AH and     reversibility of adverse mechanisms associated with this disease.   "
98561|NCT01996072|"     Primary hyperparathyroidism is a significant medical and public health problem in the world     and affects approximately 100,000 new patients in the United States alone. If left untreated     this can lead to renal stones, osteoporosis, fatigue, and depression. The best treatment for     primary hyperparathyroidism is surgical parathyroidectomy. However surgical parathyroidectomy     can be difficult due to the variant location of the parathyroid glands. Up to 5% of patients     leave the operating room without surgical cure.      Primary hyperparathyroidism is an ideal disease to investigate intraoperative fluorescent     imaging. This would allow surgeons to identify the parathyroid glands and resect the     suspicious parathyroid glands. Folate receptor (FR) has been found to be over-expressed in     parathyroid tissue and not thyroid issues. An ideal surgical treatment would combine     FR-specific fluorescent tracers with intraoperative imaging. It is important to note that FR     is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the     choroidal plexus. Thus, the false positive detection rate is expected to be extremely low.      A group well known to us in the Netherlands has completed a pilot study utilizing a     folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in     Mayo have subsequently performed this study on 20 more patients without any serious adverse     events (personal communication). They report excellent sensitivity and specificity with this     technique with only grade 1 side effects (allergic reaction). All side effects reversed when     the injection was halted. Patients with a history of allergic reactions to insect bites     should not participate (fluorescein is derived from the firefly insect, folate is an     essential vitamin).      A fluorescent contrast agent (folate-FITC or EC17) will be used to determine if it will     localize to the primary tumor nodule(s) or mass(es) of patients undergoing parathyroid     surgery.   "
98562|NCT01996059|"     The purpose of this study is to find out whether the nutritional status of patients     undergoing Functional Jejunal Interposition is better than those with Roux-en-Y After Total     Gastrectomy for Gastric Cancer. To find a better reconstruction for patients who received     total gastrectomy.   "
98563|NCT01996046|"     This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer     that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start     of new breast cancer hormone treatment and again at 12 weeks after treatment start. The     baseline uptake and change in uptake after the repeat scans will be compared to clinical long     term outcomes such as time to progression and overall survival. In addition the uptake will     be compared to the incidence of skeletal related events that are common occurrences in     patients with cancer that has spread to the bones.   "
98566|NCT01996007|"     Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and middle     ear infections), blood poisoning, and meningitis. It is frequently carried by people in back     of the throat without symptoms. Pneumococcal carriage in the Thames Valley region has been     studied over the last 12 years with carriage rates having been shown to be reflective of     disease potential and hence vaccine effect. During this time pneumococcal vaccines have been     introduced into the routine immunisation schedules of this community. The PCV7 (A vaccine     against 7 types of pneumococcus) vaccine has subsequently been noted to have had a     significant impact in reducing vaccine serotype carriage and disease. Herd protection     (indirect protection of unvaccinated individuals) has also been implicated with vaccine     serotypes not being carried in parents of vaccinated children. The most common serotype     carried since the introduction of PCV7 is 19A, which is included in the PCV13 vaccine (A     vaccine against 13 types of pneumococcus). PCV13 has superseded PCV7 in the routine     immunisation schedule, however its impact on carriage and disease in this community is yet to     be evaluated.   "
98567|NCT01995994|"     To assess the accuracy, safety, and influence of sampling site of Real-time continuous     glucose monitoring system (Medtronic Guardian).   "
98568|NCT01995981|"     This study is a phase IV post registration prospective observational feasibility study in     patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for     patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide.        -  This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose          fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker of          pazopanib treatment effect in patients.        -  It also studies pazopanib pharmacokinetics to see if there are differences between          elderly and younger patients.      The primary objectives are:        -  To evaluate whether early metabolic response is correlated to clinical benefit.        -  To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics.      The secondary objectives are:        -  To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib          therapy) is correlated with pazopanib exposure.        -  To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib          therapy) is correlated with the histological subtypes.   "
98569|NCT01995968|"     The main objective is to assess the role of antenatal detection of fetal growth restriction     (FGR) on stillbirth, by a case-control study in a population-based sample of small for     gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and     Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of     French customised birth weight curves.      Our secondary objectives are        -  to identify determinants of antenatal detection of FGR among a representative sample of          SGA births, with a special interest in the definition of FGR. Our hypothesis is that          births who are SGA by customised birthweight curves and non-SGA by population          birthweight curves, are not detected antenatally, despite the current strategy including          the use of umbilical Doppler.        -  to analyse prenatal care of a subsample of SGA stillbirths with and without detection of          FGR by a confidential enquiry.   "
98570|NCT01995955|"     The proposed study is to validate a new non-invasive imaging technique for evaluation of     cardiac microciculation in coronary artery disease with a comparison with validated technique     invasive, which is measure of index of myocardial resistance.   "
98571|NCT01995942|"     Extramural venous invasion (EMVI) is the spread of microscopic tumour cells into the veins     around the tumour. Rectal cancer treatment has improved greatly over recent years. However,     it is important for us to learn as much about the tumours as possible in order to develop     newer therapies. Current treatments may benefit from new genetic information relating to the     cancer. We hope to identify genetic differences in certain types of rectal cancer which will     allow future treatments.   "
98572|NCT01995929|"     The esophago-gastro-duodenoscopy is an endoscopic examination technique of the upper GI-tract     which was founded by the German surgeon Johann Freiherr von Mikuliicz-Radecki at the end of     19th century. By this means, the luminal site of the esophagus, stomach and duodenum may be     visualized after inserting a flexible endoscope through the mouth (transoral access). By the     rapid technical development in the last years smaller flexible video endoscopes have been     developed allowing also an alternative access to the upper GI-tract via the nose (transnasal     access).      Patients with dysphagia are referred to physicians of different disciplines     (gastroenterology, surgery, ear, nose, and throat (ENT) medicine, radiology, neurology)     performing a variety of endoscopic and non-endoscopic techniques. Mostly, the endoscopic     examination of the esophagus is done in sedated patients in left lateral examination. Typical     findings during esophagoscopy might be tumors, strictures, achalasia or diverticula.      Patients suffering from neurogenic dysphagia often get caught in the trap: they find     themselves somewhere in the space between gastroenterologist, neurologist, ENT-specialist and     radiologist. This dilemma might be due to a lack of pathophysiological knowledge among many     physicians and an inability to directly visualize the esophageal phase of deglutition. In     sedated patients lying in left lateral position, endoscopists may receive a very limited     impression of the function of the different phases of swallowing since this endoscopic access     is a rather static one.      The focus of our observational study are patients with suspected neurogenic dysphagia. These     patients shall be examined by transnasal endoscopy applying an ultrathin video endoscope with     an outer diameter of 3.8 mm (BF-3C160, Olympus Europe). Patients are examined in sitting     position while ingesting water and food of different consistencies (functional endoscopy).     Diagnostic shall be completed and correlated by videofluoroscopy, high-resolution manometry     and assessment of the clinical signs. Beside feasibility and safety as primary endpoints,     secondary endpoints shall be the assessment of pathologic endoscopic findings in patients     suffering from neurogenic dysphagia. The study is approved by the local Ethics Committee (AZ     2010-214-f-S).   "
98573|NCT01995916|"     This study has been funded by National Institute of Mental Health (NIMH) to compare two     behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric     disorder (PMDD). Both of these interventions will be run in a group format, meaning that you     will be part of a group of other women who have a menstrual mood disorder. Both of these     interventions will be run by experienced mental health professionals and both interventions     have been shown to be effective in reducing mood symptoms, increasing a sense of well-being,     and helping individuals cope with stress. While it is expected that both interventions to be     associated with some benefit, this study is designed to see which is better for women with a     menstrual mood disorder.   "
98574|NCT01995903|"     To combine several brain imaging techniques to develop a new diagnostic test to help with     earlier diagnosis of amyotrophic lateral sclerosis.   "
98575|NCT01995890|"     The Nevanac product information insert says that it can cause increase in eye pressure in     5-10% of patients. There is very little published literature on the effect of topical     Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report     this effect with a working hypothesis that there is no increase in eye pressure following use     of Nepafenac eye drops.   "
98586|NCT01995747|"     Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial fluids,     treatment of many allergic disorders remains an unmet medical need. Omalizumab was approved     for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may not be     effective for patients with much higher serum IgE levels, such as those with atopic     dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly     and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX     mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including     IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to activate     B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B lymphoblasts,     and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by anti-CεmX treatment     would inhibit the formation of IgE-producing plasma cells, resulting in a long-term     attenuation of IgE synthesis that would eventually lead to a desensitized state in allergic     patients.   "
98587|NCT01995734|"     The present study is planned as an expanded treatment protocol to provide acromegalic     patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory     approval for pasireotide is sought.   "
98577|NCT01995864|"     The study represents the research component of a broader initiative entitled RedeAmericas.     RedeAmericas (RA) is a collaborative effort of investigators from six cities across Latin     America (Buenos Aires, Cordoba, Medellin, Neuquen, Rio de Janeiro, and Santiago) and Columbia     University in New York.      This is a pilot Randomized Controlled Trial (RCT) of Critical Time Intervention—Task Shifting     (CTI-TS). It is designed to address a fundamental gap in the services offered by mental     health clinics. These clinics are the primary locale for outpatient treatment of individuals     with severe mental disorders in the urban areas of Latin America, and they offer some basic     and important clinical care such as pharmacologic treatment onsite. Generally these clinics     also have a major limitation; they have inadequate resources and training for the provision     of in vivo community-based services, that is, services delivered outside of the clinic     facility in homes or elsewhere in the community. In most urban areas, they also have weak     links to primary health care and are not easily accessible to much of the population.      CTI-TS, is a task shifting intervention that at the service user level provides support for     better community living and promotes social integration, and at the system level strengthens     the connections between mental health and primary care clinics. CTI-TS is a time-limited     9-month intervention provided at the critical time when a person is first offered services at     a mental health clinic. During this period CTI-TS workers forge relationships that will shape     the continuing use of services and enhance the potential for recovery over the subsequent     course of time. The overall goal of CTI-TS is to improve the lives of those with severe     mental disorders who receive community-based mental health care.   "
98578|NCT01995851|"     Overall, this study will determine (1) the effect of vaccine type (FluMist vs. TIV) on     immunization rates, (2) assess the feasibility of school immunization clinics, and (3) inform     a larger study to understand the effects of these two vaccines on reducing influenza.   "
98579|NCT01995838|"     This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled,     parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia.     Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25     mg) or placebo.   "
98580|NCT01995825|"     In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in     patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food     and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and     patients with epilepsy have believed that brand and generic lamotrigine have had clinically     significant differences in efficacy and tolerability. The brand name and generic tablets have     been shown to be the same when blood levels were measured in healthy volunteers without     epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study     will do this comparison, by switching patients between brand and generic in a very structured     manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other     comparisons will also be made secondarily, looking for any differences in adverse effects and     seizure control.   "
98581|NCT01995812|"     Physical activity is an important lifestyle modification for individuals with high blood     pressure. It is part of national cardiac care guidelines for hypertension management that     recommends, along with prescribing medication, lifestyle modification be promoted for     improved dietary intake, and participation in about 150 minutes of moderate exercise a week.     Native Hawaiians and other Pacific peoples (NHPP) have among the highest risk for the heart     disease, with mortality rates twice other ethnic groups. In many minority populations,     including NHPP, hypertension develops at an early age, is more severe and is less likely to     be controlled. Despite the ability of physical activity to reduce blood pressure, the     majority of U.S. population, do not meet physical activity recommendations and new     interventions that can improve accessibility and adherence, particularly among at-risk     minority populations are needed.      In this research, Hypertension and Hula: Ola Hou Pilot Study, we plan to evaluate a     culturally relevant intervention that uses hula and is consistent with the goals of     recommended physical activity for improved lifestyle - moderate-intensity, prolonged physical     activity cumulatively at about 150 minutes per week. Hula, the traditional dance form of     Native Hawaiians, is commonly practiced in Hawai'i as a cultural practice, form of creative     expression, and exercise that is structured on controlled, rhythmic movements. Combining     aspects of meditation, music, self-awareness with low-impact aerobic exercise, traditional     hula may be particularly suitable to individuals with limited mobility and fitness and within     the recommended paradigm for exercise training and secondary prevention of coronary artery     disease (CAD). We anticipate a hula and heart health education program will be particularly     appealing to Native Hawaiians and other Pacific people (NHPP) including Pacific Islanders and     Filipino who suffer from a significant disparity in cardiovascular health.      Specifically, we will determine if individuals with poorly managed hypertension and     randomized to a 12-week hula and heart health education intervention will demonstrate better     blood pressure levels, functional capacity, and exercise tolerance (6-minute walk test) than     individuals randomized to a usual care group. We will also assess if the individuals in the     hula intervention report better health-related quality of life, stress management,     perceptions of discrimination, and exercise self efficacy.   "
98582|NCT01995799|"     Ferumoxytol is an example of a 'smart' magnetic resonance contrast agent that consists of     ultrasmall superparamagnetic particles of iron oxide (USPIOs) and is avidly taken up by     macrophages. Through a previous work, the investigators have established that USPIOs can     identify inflammation in the wall of abdominal aortic aneurysms and that this is associated     with a three-fold increase in the rate of aneurysm growth. The utility of ferumoxytol for     imaging cardiovascular inflammation in other areas of the body has yet to be established but     Dr Alam has established uptake of USPIOs in the penumbra and infarct zone of the myocardium     in patients with a recent myocardial infarction. The investigators wish to assess USPIO     uptake in patients with recent acute myocardial infarction and identify the time course and     determinants of cellular tissue inflammation. This will be the first clinical study to     examine the ability of USPIOs to image myocardial inflammation following acute myocardial     infarction.   "
98583|NCT01995786|"     The aim of the study is to evaluate clinical and economic impact of Goal Directed Fluid     Therapy according to NICE haemodynamic protocol. Haemodynamic parameters were assessed using     automated pulse contour analysis (Flotrac/Vigileo®). A specific dedicated software has been     developed to perform clinical and expenditures data collection, both retrospective and     prospective data are archived.   "
98584|NCT01995773|"     Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women     with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual     cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of     life.      In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels,     cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical     activity and quality of life is studied in 40 healthy women. The results will be compared     with results from studies on women with PCOS in order to investigate any differences in these     parametres.   "
98585|NCT01995760|"     The purpose of this study is to evaluate which is the most appropriate parameter correlates     with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.   "
98588|NCT01995721|"     Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening     condition resulting in surgical interventions. The maturing and disintegrating papillomas are     the sources for the subsequent HPV relapses and immunization might slow down or even prevent     this ongoing process.      After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3     relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to     the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT     examinations to assess response to vaccination.   "
98589|NCT01995708|"     The purpose of this study is to see if the investigator can help the immune system to work     against myeloma.      This study will see if a vaccine made with altered dendritic cells will make T cells work     against tumor cells. The stem cells collected for the transplant will also be used to grow     dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then     will be injected under the skin. The investigators will do lab studies before and after the     vaccination to find out if the vaccine is working.   "
98590|NCT01995695|"     H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease     in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of     a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose     of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.   "
98591|NCT01995682|"     The study is to evaluate the feasibility of the NLA tool, a combined assessment of     nutritional and physical functional status, to provide personalized advice for the     independence and mobility of elderly.   "
98592|NCT01995669|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of GA101 (obinutuzumab) and lenalidomide that can be given to patients with     indolent NHL. The study will also look at how well the two drugs work together to control the     disease.   "
98593|NCT01995656|"     The main purpose of this study is to evaluate the safety and tolerability of the study drug     known as LY3108743 in healthy participants and in participants with type 2 diabetes.      The study will also investigate how LY3108743 affects the levels of blood sugar and other     naturally occurring substances (e.g. hormones that control the way sugar is used) in the     body, how much of the study drug gets into the blood stream, and how long it takes the body     to get rid of it.      Information about any side effects that may occur will be collected. The study is expected to     last approximately 7 to 8 weeks for each participant.      The study will have up to 3 parts. Participants may enroll in only one part.   "
98594|NCT01995643|"     The proposed study aims to investigate that consumption of grape seed extract (GSE) would     improve antioxidant status and impaired insulin action following consumption of a     pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects.   "
98595|NCT01995630|"     The purpose of this study is to evaluate differences in the depth of focus after implantation     of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation     of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to     emmetropic patients due to a larger amount of spherical aberrations.   "
98596|NCT01995617|"     GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a     randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male     and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized     in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo,     respectively. Each subject will receive up to 3 doses at 4 week intervals.      Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after     their last dose.   "
98597|NCT01995604|"     The purpose of this study is to evaluate the efficacy of dHACM (Dehydrated Human Amnion     Chorion Membrane) for reducing time to healing when used in post-laser recovery following     ActiveFX™ and DeepFx™ fractionated ablative CO2 laser resurfacing of the face.   "
98598|NCT01995591|"     Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine     Green injections around the tumour in pieces of colectomy from patients with colon cancer.   "
98599|NCT01995578|"     The purpose of this study is to learn if 5'-Azacitidine will help to lower the risk of the     disease coming back after a stem cell transplant in patients with MDS and AML. This study     will also be looking at the side effects of this medicine.      5'-Azacitidine is an FDA approved drug for treatment of MDS and AML, as well as patients     whose disease came back after transplant, where it helped going into remission. It is unclear     if 5'-Azacitidine can prevent the disease from coming back after transplant. This study will     help show if getting 5'-Azacitidine soon after transplant can lower the risk of your disease     coming back.   "
98600|NCT01995565|"     This prospective investigation studies changes in regional cerebral hemodynamics and     oxygenation as a function of cardiac output and blood pressure in intensive care patients.   "
98601|NCT01995552|"     The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%)     patients in the acute phase (at discharge from hospital after index MI) and chronic phase (at     8-10 weeks after index MI) and to correlate with patients at high risk of all-cause mortality     or sudden cardiac death (SCD) at 1 year.   "
98605|NCT01995500|"     The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR     Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison     to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute).      The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary     endpoint of angiographic in-stent late loss at 6 months.   "
98606|NCT01995487|"     The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to     the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion     failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary     endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.   "
98618|NCT01995331|"     Severe aplastic anemia (SAA)is characterized by the depletion of hematopoietic precursors     associated with life-threatening complications. High-dose cyclophosphamide has been found to     yield a complete response (CR) in adults and children with SAA.However, the optimal dosage of     cyclophosphamide for patients in childhood remains unclear. So we explore the ideal dosage of     cyclophosphamide for the treatment of children with SAA.   "
98607|NCT01995474|"     Endoscopic ultrasound and fine needle aspiration are useful tools for the diagnosis and     staging of pancreatic cancer. One potential limitation is contamination when needle traverses     the gastrointestinal tract under continuous negative pressure. Gastrointestinal tract     contamination can lead to misinterpretation of FNA specimens. We propose a technique to     eliminate any remaining negative pressure during EUS-FNA and therefore decrease     gastrointestinal tract contamination. Our hypothesis is that briefly untwisting the syringe     from the biopsy channel after a specimen is obtained eliminates any remaining negative     pressure in the FNA needle and therefore reduces GI tract contamination of EUS-FNA specimens,     and will lead to improved diagnostic accuracy of this important clinical technique.   "
98608|NCT01995461|"     The most common forms of injection used for the treatment of degenerative lumbar spinal     stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar     epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid     injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly     in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections     do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a     bilateral TESI would probably be more beneficial.      To date, there have not been any well designed prospective studies to determine the     effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC.     Therefore, the goal of this prospective, non-randomized case-series outcome study is to     evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving     function in patients with DLSS. The hypothesis is that BTESI at the level below the most     stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and     improves function in patients with DLSS.   "
98609|NCT01995448|"     Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many     clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if     they are considered separately. The extensive experimental data which have been published     contrast with the hematological data collected by the physician at patient's bedside     especially regarding neutrophils and platelets levels. When there is no obvious clinical     sign, a biological tool reflecting the patient's immune status could be useful to understand     the physiopathology of Sepsis and to predict the progression of the disease in the patient.     On the long-term it could also help to define management strategies.   "
98610|NCT01995435|"     Correlating the accuracy of a refraction done over telemedicine to that of a standard     refraction, with a study hypothesis that the results will be equivalent.   "
98611|NCT01995422|"     The main objective of this study is to evaluate the effect of a 12 weeks adapted physical     activity program (active walking) on depression by analyzing the dynamics of emotional and     cognitive functioning. The secondary objectives are to test the effects of a physical     activity on functional performance and to highlight psychological mechanisms.   "
98612|NCT01995409|"     Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight     and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to     maternal smoking or contact with second-hand smoke.      The purpose of this study is to test the feasibility of delivering and evaluating the     effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women     and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke.     The intervention will be delivered through routine antenatal and postnatal healthcare     settings provided by midwifery and health visiting services.      The intervention consists of educational materials to be given to the woman and a     conversation held between the woman and midwife/health visitor about protecting the baby from     second-hand smoke. The development of the intervention has been informed by the views of     health professionals and service users, incorporates behaviour change theory and has drawn on     other SFH materials developed for other settings. Different parts of the intervention will be     delivered at different points along the antenatal and postnatal care pathway. 200 pregnant     women and their newborns will be recruited.      We will measure salivary cotinine levels to assess the level of exposure to SHS in women and     urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the     delivery of the intervention to test the feasibility of delivering, and methods to evaluate     the effectiveness of the intervention.      Feasibility study outputs:        -  A standardised, acceptable, feasible and appropriate health education intervention to          protect unborn and newborn babies exposure to second-hand smoke at home, capable of          being integrated into routine midwifery and health visiting practice        -  A trial protocol to evaluate the effectiveness of the intervention on unborn and newborn          babies' exposure to secondhand smoke.   "
98613|NCT01995396|"     In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal     anastomoses is the gold standard. However, in patients with a weak sphincter and fecal     incontinence or in patients with severe co-morbidity and reduced general condition, this     operation is not suitable.      In these situations there are two other radical surgical options, Hartmanns procedure and the     Abdominoperineal excision that can be performed with intersphincteric dissection to minimise     perineal complications.There are no data on which of these procedures that are best suited     for these patients with fecal incontinence or severe co-morbidity( at risk for     life-threatening anastomotic leak). In this randomized study we intend to compare     postoperative complications within 30 days after these two procedures and also late     complications and quality of life after one year postoperatively.   "
98614|NCT01995383|"     This single-center, randomized, placebo-controlled, double-blind study will assess the     safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two     parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to     placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of     RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants     will subsequently receive a single IV dose of RO6836191 for further analysis.   "
98615|NCT01995370|"     To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol     (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for     secondary prevention of ischemic stroke in high-risk patients for stroke   "
98616|NCT01995357|"     The influence of the baseplate adhesive type, shape and application is investigated with     regard to the degree of leakage.   "
98617|NCT01995344|"     This is a two arm, open-labelled phase II randomised trial of Tumour Infiltrating Lymphocytes     (TIL) in metastatic melanoma patients given with preconditioning chemotherapy and     Interleukin-2 (IL2). Eligible patients will undergo surgical tumour excision from which TIL     will be derived, cultured and expanded. Patients will receive preconditioning chemotherapy     with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5     to day -1. The autologous TILs will be re-infused on day 0 and the patients will receive up     to 12 doses of intravenous High Dose Interleukin-2 (HD-IL2) or Low Dose Interleukin-2     (LD-IL2) depending on the randomised arm.      The primary objectives are response rate assessed and compared by CT scans carried out at     week 6, week 12 and at 12 weekly intervals thereafter and the evaluation of feasibility and     tolerability of TIL therapy with HD-IL2 versus LD-IL2.   "
98620|NCT01995305|"     Fanconi anemia is a rare autosomal or sex linked recessive genetic disease. The disease is     characterized by bone marrow hematopoiesis failure, multiple congenital abnormalities, and     susceptibility to neoplastic diseases. The cells of FA patients are extremely sensitive to     MMC and DEB. The symptoms and ages of FA patients are different, so by comparing the exome of     FA patients and their parents, the mutations that were accumulated in FA patients could be     found, and these genes might be sensitive to repairment and be important for hematopoiesis     maintainance.   "
98621|NCT01995292|"     The purpose of this study is to determine whether modified spray as you go technique using     the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for     the patient.   "
98622|NCT01995279|"     The aim of the present project is to examine the effects of single session of French ear     acupuncture on pain sensation and on postural control in individuals with chronic low back     pain.      We hypothesize that:      I) The application of French ear acupuncture at specific points to reduce low back pain would     decrease pain intensity in patients with chronic low back pain.      II) The pain reduction would be greater for those individuals with low back pain who receive     application of French ear acupuncture at specific points to reduce low back pain compared     with patients who receive placebo treatment.      III) The application of French ear acupuncture at specific points to reduce back pain will     have positive effect on the performance of the postural control system.   "
98623|NCT01995266|"     Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon     alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV)     Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks     post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen   "
98624|NCT01995253|"     The aim of this study was to find functions for estimating energy expenditure in free-living     conditions. This method was based on accelerometry data acquired from a smartphone worn in a     trouser pocket. The developed functions have been compared to the estimations provided by two     research devices named Armband and Actiheart.   "
98625|NCT01995240|"     Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at     an early stage. Preferably, these markers could be determined non-invasively and provide     insight into the biology of pancreatic cancer. Several MR techniques can serve for this     purpose. However, optimalisation of these techniques is needed and their reproducibility     should be assessed.   "
98626|NCT01995227|"     The purpose of this study is to determine the safety and the immunological, radiological, and     pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with     refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC     treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized     anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen     prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two     components provides a vaccine designed to bring out an immune response capable of finding and     killing the tumor cells.   "
98627|NCT01995214|"     Delirium is defined as an acute onset and fluctuating course of mental status change with     inattention and an altered level of consciousness. Delirium in the postoperative period can     be divided into emergence delirium and postoperative delirium, based on the time of onset     (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious     problem affecting the safety of patients and medical personnel. Clinical studies demonstrated     that postoperative delirium is associated with worse outcomes such as prolonged hospital     stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a;     Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the     development of postoperative delirium, including patient's medical condition, administration     of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson     & Eiseman, 2008; Deiner & Silverstein, 2009). Sevoflurane anesthesia have been reported to be     associated with more emergence delirium in pediatric patients, when compared with propofol     anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on     postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that     propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with     sevoflurane anesthesia.   "
98642|NCT01995019|"     The hypothesis is that a single dose intra-articular injection of corticosteroids are     effective in relieving temporomandibular arthralgia pain.      The purpose of the study is therefore to evaluate the effect of a single dose intra-articular     methylprednisolone vs. placebo in a month perspective on subjects with unilateral arthralgia     of the TMJ.   "
98694|NCT01994330|"     Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic     stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has     received the name of Heye´s syndrome.      We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve     replacement surgery will reduce blood loss and transfusion rate.      this was a pilot study   "
98628|NCT01995201|"     This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously     administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with     methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis and an     inadequate response to non-biologic DMARDs or to one anti-TNF. In Phase 1, all patients will     receive RoActemra/Actemra 162 mg subcutaneously (sc) weekly for Weeks 1 to 24, with or     without methotrexate or other non-biologic DMARDs. For Part 2, patients who achieve sustained     clinical DAS28-ESR remission at Weeks 20 and 24 will be randomized to receive     RoActemra/Actemra 162 mg sc either weekly or every 2 weeks for Weeks 24 to 48, with or     without methotrexate or other non-biologic DMARDs. Patients who do not achieve sustained     clinical remission but achieve low disease activity (DAS-ESR </= 3.2) will continue the     initial treatment of RoActemra/Actemra 162 mg sc weekly for Weeks 24 to 48, with or without     methotrexate or other non-biologic DMARDs.   "
98629|NCT01995188|"     This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of     DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous     Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused     DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The     combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab     [Avastin] in three dose expansion cohorts.   "
98630|NCT01995175|"     The purpose of this study is to assess the incidence and associated healthcare utilization of     RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of     age, and also to assess the accuracy of a newly developed LRTI case definition and severity     scale compared to two existing definitions. The study will also assess the population     attributable risk percent of RSV LRTI on the development of wheeze and asthma from 0 to 6     years of age.   "
98631|NCT01995162|"     The aim of this study was to validate functions for estimating energy expenditure in     free-living conditions. This method was based on accelerometry data acquired from a     smartphone worn in a trouser pocket. The developed functions have been compared to the     estimations provided by two research devices named Armband and Actiheart.   "
98632|NCT01995149|"     Background: Lipid lowering response to weight loss in subjects with genetic hyperlipidemias     and overweight or obesity and its effect on cholesterol metabolism has not been studied.      Objective: To explore the effects of weight loss on lipid values and cholesterol metabolism,     by measuring circulating non-cholesterol sterols, in overweight or obese subjects with     genetic hypercholesterolemias.      Design: The investigators conducted a 6-months weight loss intervention in subjects with the     diagnosis of familial hypercholesterolemia (FH) or familial combined hyperlipidemia (FCHL),     body mass index >25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid     lowering drugs in the previous 5 weeks. They were advised to follow a hypocaloric diet with a     deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated from     the person's resting energy expenditure and activity level. Anthropometric data, biochemical     analysis including lipids, apolipoproteins and non-cholesterol sterols were evaluated at     baseline, 3 months and 6 months.   "
98633|NCT01995136|"     The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004%     ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.   "
98634|NCT01995123|"     The purpose of this study is to examine whether behavioral activation as an adjuvant to     standard smoking cessation treatment improves smoking cessation outcomes among veterans with     PTSD relative to a comparably intense combination of standard smoking cessation treatment +     health and smoking education. It is expected that behavioral activation will produce more     successful results than health and smoking education when paired with standard smoking     cessation treatment.   "
98635|NCT01995110|"     The study will quantitatively evaluate the metabolic response of normal weight and obese     subjects to three high-fat meals differing in caloric dose by analysing the postprandial     blood transcriptome.   "
98636|NCT01995097|"     Primary Aim: To test the efficacy of a SMS text-based scheduled gradual reduction (SGR) and     counseling intervention to promote smoking cessation in the late third trimester.      Hypothesis: The rate of smoking cessation in the late third trimester among women in the SGR     Support Messages arm will be higher than among women in the Support Messages arm.      Secondary Aim 1: To assess the effect of the SGR intervention on biochemically validated     prolonged abstinence and smoking reduction during pregnancy.      Secondary Aim 2: To assess the effect of the SGR intervention on smoking abstinence at three     months postpartum.      Secondary Aim 3: To assess the effect of the SGR intervention on the rate of preterm birth.   "
98637|NCT01995084|"     Several studies have shown that tumour hypoxia may have a negative impact on the outcome of     anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of     treatment may serve as a predictive marker to determine treatment efficacy at an early stage.     Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging     with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue,     3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol     (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be     clinically implemented for response prediction, the reproducibility of the technique should     be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine     what change in parameters between two examinations can be considered relevant in an     individual patient. Assessment of reproducibility becomes even more important in early     response monitoring since the changes in the tumor induced by the treatment may be smaller     during the treatment compared to response monitoring after completion of treatment. Also, as     image quality of 18F-HX4-PET increases with increasing time intervals after injection,     determination of the optimal time point for measurement of hypoxia is warranted.   "
98638|NCT01995071|"     The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of     ABT-493 and ABT-530 in adults with genotype 1 HCV.   "
98639|NCT01995058|"     This study is designed to evaluate the safety and efficacy of combining abiraterone (with     prednisone) with cabozantinib in chemotherapy-naïve subjects with bone-metastatic     castration-resistant prostate cancer (CRPC).   "
98640|NCT01995045|"     The aim of this study is to evaluate if patients receiving a steroid (triamcinolone     acetonide) combined with local anesthesia and antibiotic following retina surgery have better     postoperative pain control those receiving local anesthesia and antibiotic alone.   "
98643|NCT01995006|"     The planned study is a single-center, randomized, open-label parallel group study in 16     healthy male subjects. Study subjects will be randomly allocated either to the metamizole     group (1) or to the naproxen group (2). All participants will start with a low sodium diet     (approximately 50 mmol Na+ per day) 7 days before the first drug intake and maintain the diet     until the end of the study (14 days in total). Salt-depletion is an accepted model to enhance     production of vasodilatory prostaglandins and to increase renal sensitivity to prostaglandin     inhibition. On the first day of treatment (Day 1), a single dose of metamizole or naproxen     will be administered to investigate the effects after a single dose and to collect single     dose pharmacokinetic profiles. Starting on Day 2, all participants will receive therapeutic     doses, i.e. 1000 mg metamizole 'ter in die' (TID, three times a day) or 500 mg naproxen 'bis     in die' (BID, twice a day) for one week and on Day 7 pharmacokinetics and pharmacodynamics     effects will be assessed under near steady-state conditions.      The primary objective is the characterization of the renal effects of metamizole by     determination of the glomerular filtration rate (GFR) using the inulin clearance. Secondary     objectives are the characterization of the urinary excretion of prostaglandin E2 (PGE2) and     the prostaglandin I2 (PGI2) metabolite 6-keto-prostaglandin F1 (PGF1)alpha as well as the     urinary excretion of sodium and potassium.      Overall, clinical experience suggests better renal tolerability of metamizole possibly due to     less potent COX-inhibition compared to classical nonsteroidal antiinflammatory drugs     (NSAIDs). If this could be confirmed, metamizole would be a valuable alternative for     treatment of painful conditions in patients with impaired renal function. Therefore, the aim     of this study is to examine the effects of metamizole on renal function in comparison with     the non-specific COX-inhibitor naproxen.   "
98647|NCT01994954|"     The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase     rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth     compared to standard oxygen management protocols.      Evidence-based specific consensus guidelines for home regulated oxygen management do not     currently exist. Current strategies for infants requiring outpatient supplemental home oxygen     include brief checks of oxygen status during monthly clinic visits. Although the infants stay     on monitors, no data in between visits is obtained to ensure that infants can maintain oxygen     levels after weans are made. Before finally allowing oxygen to be removed, many centers also     require an overnight sleep study in the hospital, to make sure that the infant's oxygen     levels stay safe when the infant is in deep sleep. Because these methods rely solely on     assumptions rather than individually recorded data, an infant's time on supplemental oxygen     may be prolonged or insufficient. This study will evaluate both the currently used accepted     therapy and a method of weaning that involves recording and sending oxygen data for analysis     in between clinic visits.      Premature infants who require home oxygen therapy at time of discharge who meet eligibility     criteria will be randomized into two arms:      Arm A (Standard therapy): Infants' oxygen will be increased, decreased, or maintained based     on brief structured assessments during monthly clinic visits.      Arm B (Recorded Home Oximetry (RHO)): Infants will have the same monthly clinic assessments     as in Arm A, but also will utilize Recorded Home Oximetry (RHO) to potentially increase,     decrease or maintain oxygen between monthly visits.      Parents of all infants will be interviewed using structured quality-of-life questionnaires at     the beginning and ending of the oxygen management process. Health care utilization (emergency     department visits and rehospitalizations) and growth will be assessed 6 months after     discontinuation of oxygen.      The investigators overall objective is to determine whether Recorded Home Oximetry (RHO) can     improve caregiver quality of life, and can shorten Home Oxygen Therapy (HOT) duration and     eliminate need for polysomnogram, without compromising safety. The investigators will     determine respiratory-related re-hospitalizations, emergency department (ED) visits, and     growth parameters to confirm safety of the proposed weaning strategies.   "
98648|NCT01994941|"     This study aims to compare the outcome between genotype guided versus clinical guided     approach in selection of oral P2Y12 receptor blocker in Chinese patients suffering from acute     coronary syndrome.   "
98649|NCT01994928|"     Preoxygenation is routinely performed before endotracheal intubation. In the intensive care     unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that     high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic     respiratory failure, is equally effective in preventing the development of hypoxemia during     intubation. In this prospective randomized study preoxygenation using high flow nasal cannula     oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic     respiratory failure.   "
98650|NCT01994915|"     Chronic obstructive pulmonary disease is a chronic condition involving an impairment in     functionality and in the execution of activities of daily life. The hypothesis of this study     is that an occupational therapy intervention added to a physiotherapy program and a medical     treatment increase the functionality and the quality of life of patients with chronic     obstructive pulmonary disease.   "
98651|NCT01994902|"     The aim of the investigation was to investigate the performance and safety of a new ostomy     product.   "
98652|NCT01994889|"     This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily     dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with     either transthyretin genetic variants or wild-type transthyretin resulting in amyloid     cardiomyopathy.   "
98653|NCT01994876|"     To investigate the performance and safety of two newly developed convex 1-piece ostomy     appliances   "
98654|NCT01994863|"     The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse)     in reducing leakage (4-point scale) compared to Standard of Care.   "
98655|NCT01994850|"     This is a Phase I/II multicenter single arm non-randomized open label study of the     investigational drug, brentuximab vedotin, given in combination with routine chemotherapy     (rituximab, cyclophosphamide, doxorubicin and prednisone) every 3 weeks for a total of 6     cycles.   "
98656|NCT01994837|"     A Phase 2, Open-Label, Multicenter study evaluating the preliminary efficacy and safety of     ABT-199 administered orally in patients with AML.   "
98657|NCT01994824|"     Graft-vs-host disease (GVHD) causes substantial mortality, morbidity and poor quality of life     after blood or marrow transplantation (BMT). In Alberta, we use antithymocyte globulin (ATG,     given on days -2, -1 and 0) in addition to methotrexate and cyclosporine for GVHD     prophylaxis. In spite of that, ~40% patients develop significant GVHD (grade 2-4 acute GVHD     or chronic GVHD needing systemic immunosuppressive therapy). ATG at the dose we typically use     (4.5 mg/kg) is relatively non-toxic. At higher doses, ATG could increase the likelihood of     posttransplant infections or relapse. Thus an extra dose of ATG (on top of the routine 4.5     mg/kg) might be justified only for patients at high risk of developing significant GVHD. In     our experience, low serum level of interleukin-15 (IL15) and high serum level of     interleukin-2 receptor alpha (IL2Ra) on day 7 predict development of significant GVHD. Here     we will test whether, compared to historical/concurrent controls, an extra dose of ATG (3     mg/kg on day 8) given to patients with low IL15 or high IL2Ra on day 7 reduces the incidence     of significant GVHD, and improves survival free of relapse and GVHD, and quality of life.   "
98661|NCT01994772|"     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for     250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of     life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the     initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the     improvement of mortality and neurological outcome has been achieved over the last decade     thanks to the systematic implementation of a period of targeted temperature control between     32 and 34 ° C in patients who benefited from the realization of at least one electrical     external shock.      There are theoretical and clinical arguments to think that achieving the same way a period of     targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest     with a non- shockable rhythm on arrival can also benefit from this procedure. However other     arguments are against this hypothesis including an increase in the risk of infection ,     worsening of the patient's hemodynamic status with no benefit to him. To answer this     question, we conduce a randomized multicenter study testing the potential improvement of     neurological outcome through this procedure targeted temperature control between 32.5 and     33.5 ° C in these patients.   "
98662|NCT01994759|"     The purpose of this study is to determine whether reduced load to patients with plantar     fasciitis (reduced standing, walking, landing) together with either controlled heavy     resistance training or glucocorticosteroid injection or a combination thereof is the best     treatment.   "
98663|NCT01994746|"     The primary objective of this study is to assess the effectiveness and safety of 3 mg     glucagon (AMG504-1) administered as a puff into the nose compared with commercially-available     glucagon given by injection.   "
98664|NCT01994733|"     Patients with end-stage renal disease (ESRD) who have elevated serum phosphate (P) levels     have significantly higher mortality rates compared to those with normal P. In patients     receiving conventional dialysis regimens, serum P may be lowered through dietary intervention     and use of P binders, though these have potentially important side effects and may adversely     impact quality of life. Whether lowering P, and / or targeting specific P levels improve     survival and clinical outcomes is unknown. Despite this uncertainty, over 90% of patients     with ESRD receive P lowering therapy and guidelines for the care of patients with ESRD are     increasingly calling for more aggressive phosphate lowering. This intensive P lowering     results in extra medications (and their associated side-effects), and higher health care     costs. We are uncertain whether the intensification of P control results in measurable     benefits to patients with ESRD. The overall goal of this pilot trial is to evaluate the     feasibility of conducting a randomized controlled trial of intensive vs liberalized phosphate     control among hemodialysis recipients.   "
98665|NCT01994720|"     The primary objective of the study is to compare the effect of 90-day treatment with     ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily     maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300     mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance     dose for the remainder of the study) for the prevention of major vascular events (composite     of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or     transient ischaemic attack (TIA).   "
98666|NCT01994707|"     The investigators aim to definitively show if human myocardium can be remotely     preconditioned. In the writings there are no experiments that would prove that the remote     preconditioning protocol effects on the higher protection of the human myocardial cells,     against the ischemia-reperfusion injury.      120 patients referred for coronary artery bypass grafting (CABG) procedure with use of     cardiopulmonary bypass are planned will be included to the research. Patients will be     randomized (1:1) to one of two groups: remote preconditioning or placebo intervention. On     the day of surgery, after induction of anesthesia remote preconditioning will be elicited by     3 cycles of 5min inflation (ischemia) and 5 min deflation (reperfusion) of blood pressure     cuff on the right arm. In the control group the blood pressure cuff is going to be placed on     the upper limb but the preconditioning protocol will not be carried out. On cannulation for     CPB, right atrial appendage and myocardial biopsies of the left ventricular will be     harvested. The investigators will study: (1) resistance of myocardium to hypoxia/reperfusion     injury in in vitro experiments, assessed in isolated right atrial pectinate muscle trabeculae     (2) induction of apoptosis and status of mitochondria in myocardium after the period of     ischemia, and reperfusion in vitro (3) amount of myocardial necrosis in-vivo induced by     period of ischemia and reperfusion during CABG as assessed by postoperative myocardial     necrosis markers release (4) the systolic function of the myocardium at the postoperative and     the kidney function in the postoperative period evaluated by the creatinine clearance; (5)     induction of apoptosis and status of mitochondria in myocardium after the period of ischemia,     and reperfusion during coronary artery bypass grafting, assessed in myocardial.      There is going to be an ability to define does the remote preconditioning influence on the     occurrence of apoptosis in the human myocardium in the in vivo conditions and does it     influence on the postoperative course in patients undergoing cardiac surgery procedures. The     investigators will try to study if remote preconditioning modify induction of apoptosis and     its structure in response to injury. In case the effect of remote preconditioning is not     measurable in ex-vivo assessment, the future attempt at implementing this phenomenon in     clinical practice may be futile and should not be continued until the effect can be confirmed     in controlled experimental setting.   "
98667|NCT01994694|"     People with ADHD often engage in risky behaviors, such as dangerous driving, substance abuse     and gambling. Current behavioral economy theories differentiate between risk perception and     risk attitude. This study aims to measure both risk taking and risk perception in adults with     and without ADHD. It is hypothesized that people with ADHD show decreased risk perception,     accounting for their risky behavior. In contrast, it is hypothesized that people with ADHD do     not show increased risk attitude, namely, they are not risk seeking.   "
98668|NCT01994681|"     Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the     Spectrosense EVA system, which is combination of a gas chromatography (GC) and software     algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the     best discrimination between Pancreatic Cancer sick population and healthy population. The     gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.   "
98669|NCT01994668|"     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg     lorazepam intravenous administration in healthy Japanese adult subjects.   "
98670|NCT01994655|"     Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.   "
98671|NCT01994642|"     The objective of this study is to compare the relative efficacy and safety of the test     formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the     already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic     suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent     tympanostomy tubes.   "
98672|NCT01994629|"     Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross     reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old     healthy toddlers.   "
98674|NCT01994603|"     This trial will pilot test intervention strategies to increase utilization of HIV testing and     gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV     sexual transmission in the general population in Russia. The study will assess whether     external (cost, convenience) or internal factors (low perception of own risk, reluctance to     identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested     and if peer support impacts their decision. A randomized experimental manipulation, comparing     opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed     by a second-chance testing offer will be used to inform these questions. The answers will     enable the international research team to engineer and then test an HIV testing promotion     strategy in Russia. The project will collect preliminary data for a larger study to develop     an evidence-based program to reduce the HIV transmission in this high risk population.   "
98675|NCT01994590|"     The goal of this clinical research study is to learn if adding dovitinib to the combination     of abiraterone acetate and prednisone may help to control metastatic CRPC. The safety of this     drug combination will also be studied.   "
98676|NCT01994577|"     Blood tests may be able to quickly identify and exclude patients that are having a heart     attack. Using these tests in the Emergency Department (ED) may lead to faster treatment, a     reduced wait time, and quicker discharge for patients presenting with symptoms suggestive of     a heart attack.   "
98731|NCT01993849|"     To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC)     in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy     on young adults who bite their fingernails. It is proposed that NAC will help decrease     fingernail biting.   "
98677|NCT01994564|"     Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons     (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter     the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual     field defects at certain locations. Furthermore, the retinal nerve fiber layers from     different receptors for different colors are ordered in a special manner as well. Thus, it is     possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia).      At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or     only in end-stage glaucoma.      By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma     and in different stages of the disease will be investigated.   "
98678|NCT01994538|"     This study will investigate the treatment of urinary tract infection in men. Specifically,     the investigators are looking to see if shorter duration of antibiotics (7 days) is any worse     than longer duration of antibiotics (14 days). The investigators will also study whether     longer treatment leads to an increase in antibiotic resistant bacteria in the large intestine     (colon), or an increase in drug side effects.   "
98679|NCT01994525|"     This study is to assess the safety, tolerability, and biomarkers of protection in healthy     malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either     infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected     (mock-immunization).   "
98680|NCT01994512|"     A national randomized multicentre trial (RCT) where decompression is compared with     decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two     adjacent lumbar levels with or without degenerative olisthesis. The material is stratified     for the existence of degenerative olisthesis >3mm. Monitoring is performed with clinical     results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT     and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null     hypothesis is that there is no difference in results between the two interventions.   "
98681|NCT01994499|"     Infectious pleural effusion is a classic complication of pneumonia and often require pleural     drainage.      There is no consensus between surgical drainage and medical drainage indication in first     intention to treat an empyema.      Usually surgery is proposed in second intention after failure of medical drainage.      Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The     morbidity of this approach is very low with good results and become the gold standard in     different pleural diseases. The medical drainage can be also very efficient but its results     depends of the evolution of the pleural effusion. The rate of failure is estimated around     25%.      Then, the aim of our study is to compare surgical drainage and medical drainage in first     intention. The first end-point will be the hospital stay (day). Hospital discharge will be     strict, following different objective criteria of healing allowing comparison between these     two approaches of drainage.      To answer this question we will randomized 50 patients in 2 years with a multicenter     recruitment.   "
98682|NCT01994486|"     This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with     genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in     combination with sofosbuvir (SOF) for 12 weeks.   "
98683|NCT01994473|"     This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its     metabolite SEP-363854 in male and female subjects with schizophrenia.   "
98684|NCT01994460|"     The current standard short-course treatment for pulmonary TB requires 6 months to complete.     This long duration of treatment increases the likelihood of side effects while decreasing     patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against     refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as     well as the possible adverse effects of its long-term use, it is rational to use linezolid     instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB.     Through randomized controlled trial, the investigators will evaluate the hypothesis that the     use of linezolid instead of ethambutol will increase the sputum culture conversion rate by     15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be     randomized to the following three arms at a 1:1:1 ratio: Arma 1 (control arm), Arm 2     (linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of     ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of treatment     (liquid media).   "
98705|NCT01994187|"     Investigate the current situation of carotid stenosis therapy in China. Establish the data     bank of carotid stenosis revascularization (CAS and CEA) in China ,in order to get best     quality control of the therapy, as well as confirm the standard treatment for carotid     stenosis.      Understand situation about the adverse events occurs after the revascularization (CAS and     CEA), evaluate the health economics .   "
98685|NCT01994447|"     Project Summary: One of the challenges facing pediatric researchers is the need to balance     decreasing funding with the time and human resource costs associated with enrolling children.     In order to address this, the Emergency Department (ED) research team developed an innovative     model for subject enrollment and consent using highly trained and supervised undergraduate     students. From a human resources perspective, utilizing students is more cost effective than     the traditional research nurse model. However, a concern with this method is the adequacy of     parental understanding of study information for informed consent. The aim of this project is     to determine if the use of students is at least as good as the more costly gold standard of     experienced research nurses. The validation of this innovative student model will enable     child health investigators to better meet parent's needs and increase the efficiency of     pediatric research.      The primary objective of this study is to measure parental comprehension of informed consent     information using an innovative undergraduate research assistant program compared to consent     using the traditional research nurse model. We hypothesize that parental comprehension of the     informed consent information process when approached by undergraduate students will be     comparable (or not worse) than when consent is obtained by a research nurse.   "
98686|NCT01994434|"     Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of     this study are to report a series of 9 patients with pure ulnar nerve deep branch compression     by a ganglion and to evaluate the outcome following a surgical treatment. According modified     Bishop's scoring system, the investigators would evaluate postoperative results of this     uncommon nerve lesion.   "
98687|NCT01994421|"     Background: Kinesiotaping (KT) is an elastic therapeutic tape developed in the 70's by Dr     Kenso Kase for prevention and treatment of sports injuries. Research shows that through     activation of skin receptors KT improves blood and lymph flow, increases proprioception,     helps relieve pain, facilitates joint and muscle alignment, and enhances muscle function.     Despite the increasing popularity of KT, uncertainty remains regarding, in particular, its     effectiveness in improving strength.      Purpose: The purpose of the current study was to investigate the short-term effects of KT on     muscle strength when applied to the quadriceps muscles of healthy subjects.      Methods: A randomized controlled trial with 52 healthy subjects was conducted. Subjects were     tested under four different conditions: a) facilitating Kinesiotape, b) inhibiting     Kinesiotape, c) classical tape with no elastic properties, and d) no-taping across four     different sessions. The parameters of interest were: quadriceps and hamstrings maximal     strength and power using vertical jump tests (squat jump and countermovement jump), and peak     concentric and eccentric knee torque (using isokinetic test protocol).   "
98688|NCT01994408|"     High blood pressure leads to heart attacks and strokes which can be prevented by blood     pressure-lowering medication. However, the current office-based prescription of one pill and     one dose at a time is ineffective. the investigators want to pilot-test a more effective     patient-centered treatment approach, where patients will receive a prescription with gradual     but automatic weekly increases of dose and number of pills. Patients will measure their blood     pressure with an iPhone compatible cuff, which transmits readings to the doctor or     pharmacist, who will stop escalation when the desired blood pressure level is reached. The     investigators hypothesize that the intervention will decrease the time to control blood     pressure and increase the overall rate of blood pressure control. Therefore, this new     treatment model could prevent heart attacks and strokes, and reduce healthcare costs.   "
98689|NCT01994395|"     Hypothesis/Specific Aims:      The purpose of this study is to determine the effect of training with the Stride Management     Assist (SMA) device vs. Impairment based physical therapy (IPT) on descending corticospinal     drive to the lower limb muscles in patients post stroke. The investigators hypothesize that     long-term SMA use would strengthen the connections between the motor areas of the brain and     the lower limbs. Specifically, individuals in the SMA group will show higher corticospinal     excitability of the lower limb muscles compared to those in the IPT group.   "
98690|NCT01994382|"     This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070)     that may be given in patients with relapsed/refractory chronic lymphocytic leukemia or     non-hodgkin lymphoma   "
98691|NCT01994369|"     Breast cancer is the most common cancer and the second cause of cancer mortality in women.     There are approximately 200,000 new cases of breast cancer a year. Classically, breast     cancers are divided into two groups, invasive and non-invasive. A mainstay of the treatment     of both of these types is surgical resection not only for therapeutic purposes but also for     diagnostic purposes. Breast conserving therapy includes surgical lumpectomy and     post-operative radiation. However, despite best surgical practices, when patients undergo BCT     anywhere from 20 - 40% of these patients have margins positive for cancer. This leads to     increased rates of reoperation which are quoted to be as high as 30% and increased local     recurrences.      There is an over expression of folate receptors located on the surface of many human     carcinoma nodules.Specifically for breast cancer up to 33% of all breast cancers over express     the folate receptor.      Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, targets folate     receptors over expressed in certain cancers such as breast cancer, and could help in better     identifying the margins of the cancer thereby achieving negative margins.   "
98692|NCT01994356|"     As many as one-third of female healthcare providers use intrauterine contraception (IUC), but     only about 8 percent of US women overall do. This begs the question: Might physician     self-disclosure of personal IUC use increase IUC use among patients? However, the positive or     negative impact of physician self disclosure on IUC uptake or patient satisfaction is     generally unknown. The purpose of this study was to evaluate if physician self-disclosure of     personal IUC use increases patient use of IUC or impacts patients' satisfaction with their     clinical encounter.   "
98693|NCT01994343|"     Chronic pelvis pain is very common between adult women. Significant progress is made in     clarifying the multifactorial model of chronic pain pathogenesis, but a more complete     assessment is important in order to improve the therapeutic approach. The purpose of this     study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.   "
98727|NCT01993901|"     The principal aim of this study is to prospectively assess if Clinical Specialist Radiation     Therapist (CSRT) led telephone follow up after treatment with lung Stereotactic Body     Radiation Therapy (SBRT) has an impact on patient symptom burden as assessed by Edmonton     Symptom Assessment Scale (ESAS) scores.   "
98695|NCT01994317|"     This study aims to compare an algorithm for IV sedation dosing to the current standard of     care in patients undergoing first trimester surgical abortion. The primary outcome is     subjects' pain score with suction curettage on a 0-100 21-point scale. Secondary outcomes     include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain     ratings, incidents of side effects and adverse events, the frequency of additional doses of     medication, recovery room time, and physician assessment of and satisfaction with pain     control. Investigators hypothesize that this algorithm will result in improved pain control,     decreased frequency of additional medication doses, improved patient and physician     satisfaction, without differences in side effects, adverse events or recovery room time.   "
98696|NCT01994304|"     PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in     preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental design     with data collection from 34 facilities across six intervention districts and four control     districts. The study with a sample of 137,000 births has 88% power to detect 15% reduction in     intrapartum mortality. Data on this was collected over a period of 17 months (November 2013     to April 2015).   "
99091|NCT01989117|"     Osteopathy is an alternative healthcare that seems effective in relieving the pain of     patients. The main purpose of this study is to evaluate the efficacy of preoperative     osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The     secondary objectives are to assess pain during the first postoperative month on a VAS and     knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy     will decrease postoperative pain and increase knee function.   "
98697|NCT01994291|"     The study hypothesis under test is that administration of the CCR2/5 antagonist has the     potential to be as effective as the current treatment options for subjects with diabetic     macular edema. The current treatment option for these subjects is an injection directly into     the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be     just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and     might be able to provide an alternative mechanism to treat Diabetic Macular Edema.   "
98698|NCT01994278|"     The aim of this study is to observe whether a brushless cleaning device can be equally as     effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people     an alternative to bristle brush cleaning if they find they are brushing too hard. The     hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless     methods in conjunction with flossing.   "
98699|NCT01994265|"     Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to     thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in AF     patients, despite effective, remains beyond desired levels because of interactions with food     and fluctuations in blood levels. Because of a more stable anticoagulation state, Dabigatran     may offer better protection against thrombotic phenomenon and, consequently, mitigate the     process of cognitive and functional compromise.   "
98700|NCT01994252|"     Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are     encountered with an increase in death and suffering. When both these two conditions occur in     a patient, the patient's prognosis is poor with a reduced quality of life and impaired heart     function. These patients have enlarged hearts, specifically the left ventricle (major pumping     chamber), which impairs the heart's pumping capacity, leading to symptoms such as fatigue,     shortness of breath from any type of exertion, and swelling, usually of the feet and ankles.      In these HF patients who are in AF all of the time, who would otherwise be a suitable     candidate for an implantable defibrillator to prevent sudden cardiac death, we would like to     determine whether adding pacing of both ventricles will reduce heart size (left ventricular     end systolic volume index LVESVi) as measured by ultrasound, which can improve its function     and help the heart pump more efficiently.      Other studies have shown that adding pacing to both ventricles is of benefit in HF patients     with mild to moderate symptoms and have a regular heart rhythm. The Investigators now want to     explore if this therapy will benefit those patients with a permanent irregular heart rhythm     (AF).   "
98701|NCT01994239|"     The purpose of this study is to select the best therapeutic strategy in studying the     effectiveness of the association of a short duration hormonal therapy and radiotherapy     compared with radiotherapy alone, in patients with a detectable PSA after radical     prostatectomy.   "
98702|NCT01994226|"     Gout is the most common cause of inflamed joints affecting 1.4% of adults in the UK. Most     patients are treated entirely in general practice yet primary care management is frequently     suboptimal. Acute attacks of gout are excruciatingly painful and require urgent drug     treatment to reduce inflammation, most commonly with antiinflammatory drugs(NSAIDs) or     colchicine. In primary care, NSAIDs are most commonly used but can cause serious side effects     such as stomach ulcers and heart disease, particularly in the elderly. Patients frequently     require repeat prescriptions for recurrent attacks of acute gout increasing the risk of     drug-related side-effects. Low-dose colchicine is popular amongst rheumatologists as it is     effective and well tolerated. However, general practitioners (GPs) prescribe colchicine     infrequently, probably because in the past the recommendation was for high doses to be     prescribed which commonly caused severe diarrhoea. Recently, prescribing recommendations for     colchicine have changed, advocating a lower dose regime.      Currently there is no evidence regarding whether NSAIDs or low-dose colchicine is the best     treatment for acute gout. This trial will be the first direct comparison of the effectiveness     and side effects of a NSAID (naproxen) and low-dose colchicine to treat acute gout in primary     care. Naproxen will be used in this trial because it has been shown to be as effective as     oral prednisolone for the treatment of acute gout, is safer than other commonly used NSAIDs     such as diclofenac and indomethacin, and is inexpensive.      Patients consulting their GP with an acute attack of gout in up to 100 general practices will     be invited to participate. Treatment success will be assessed by comparing pain reduction     between the two drugs. The trial will also monitor side effects, quality of life, and cost     effectiveness.   "
98703|NCT01994213|"     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and     Flt3. Phase I study has shown that the toxicity is manageable.      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in     patients with advanced or metastatic Gastroenteropancreatic Neuroendocrine Tumor.   "
98704|NCT01994200|"     While thyroid cancer is generally associated with a favourable prognosis, there is a     discrepancy with how important if not traumatic its impact can be on patients. Quality of     life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an     optimal period for a preventive intervention. The goal of this study is to evaluate the     impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid     cancer patients, including a dedicated nurse who will provide important psychoeducational     elements identified in previous focus group studies of thyroid cancer patients, i.e.,     information on: the physical illness; the emotional impact of being newly diagnosed with     thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine     treatments and its associated safety precautions, nutrition and dietary considerations; and     how the cancer diagnosis can be an opportunity to make important lifestyle changes and     establish new life-priorities.   "
98728|NCT01993888|"     To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch     (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during     hepatic surgery.   "
98706|NCT01994174|"     The objective of this research is to determine the effects of anti-VEGF drugs (bevacizumab,     ranibizumab or aflibercept) on aqueous humor dynamics (AHD) in patients with retinal vascular     disease. The underlying hypothesis is that anti-VEGF drugs increase intraocular pressure     (IOP) by increasing aqueous inflow, decreasing uveoscleral outflow or both. The specific aim     is to evaluate the changes produced in AHD after 3 monthly injections of anti VEGF agents.   "
98732|NCT01993836|"     This study will examine the hypothesis that changes in the cognition (i.e. thinking and     memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers     Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF),     and/or changes in brain connectivity. The investigators will also examine whether different     types of anesthesia have different effects on these CSF markers of Alzheimers disease, or     different effects on thinking and memory after anesthesia and surgery, or differential     effects on the correlation between cognitive changes and CSF marker changes.   "
98733|NCT01993823|"     The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of     otomycosis   "
98707|NCT01994161|"     This trial is an prospective, government-funded registration study that will observe the     safety and effectiveness of intracranial stenting for preventing stroke during a mean     follow-up of 12 months in patients with symptomatic stenosis of a major intracranial artery     (MCA, carotid, vertebral, basilar). This trial will be launched by Xuanwu Hospital, Capital     University of Medical Science, with 20 collaborators participating. Enrollment will begin in     2013, and it aims to have a sample size of 840 subjects in 2 years. The trial is scheduled to     complete in 2015.      As we know, SAMMPRIS is flawed with defect in design, heterogeneity in experience and     credentials of operators and high rate of complication; Whether the interventional therapy     for symtomatic intracranial artery stenosis is effective or not remained resolved. This trial     has been modified based on SAMMPRIS in order to acquire the data for China: Technique,     experience, and credential of the operators are closely related with perioperative     complications in PTAS. The investigators select 50 large-scale medical centers for     participation on the basis of geographical distribution. All the participants are ranked as     top in China. They have the most experienced surgeons or interventionist in China, and are     fully qualified for this trial. This will guarantee the success and safety of technique,     maintain the continuity of operator's experience, and make the complication rate as low as     possible.   "
98708|NCT01994148|"     laparoscopy has been increasingly applied in patients with abdominal trauma , as an     diagnostic and therapeutic modality. However, its clinical benefits are still under     evaluation. The aim of this study is to prospectively assess the feasibility and safety of     this technique in the management of traumatic gastrointestinal injury.   "
98709|NCT01994135|"     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the     blood glucose levels. After a meal or drink, blood glucose levels rise until it reaches a     peak concentration usually after 30 minutes. When the body senses the increase in blood     glucose, a hormonal process involving insulin takes place to ensure that the glucose is taken     up from the blood for storage and where it is needed for energy in the body. This process     then brings about a decrease in the concentration of glucose until it reaches approximately     the starting concentration. The original concentration of glucose is attained approximately 2     hours after eating or drinking a carbohydrate food or sugary drink respectively.      Different carbohydrates and sugary drinks have different effects on blood glucose response     depending on the amount as well as the type of carbohydrate. Those that give rise to a high     glucose response compared to a reference carbohydrate (usually glucose) are said to be high     glycaemic index (GI) foods and those with a lower glucose response compared to a reference     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.(1)      Research has shown that diets that give rise to a high glucose response are associated with a     number of abnormalities like increased metabolic syndrome (2). Metabolic syndrome mostly     comprises of insulin resistance and glucose intolerance which gives an increased risk of type     2 diabetes. (3) It also gives rise to other conditions like high blood pressure (arterial     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.     (4) Research has also shown that foods/drinks which raise blood glucose levels gradually (low     GI) rather than rapidly (high GI) have health benefits which include reducing the risk of     metabolic syndrome (5). In vitro studies have shown that polyphenols found in fruits,     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can     lower the blood glucose levels. (6)      This research will determine whether the presence of polyphenols in the diet has any lowering     effect on the blood glucose levels and hence the glycaemic index of foods. This will be     determined by asking volunteers to consume polyphenol rich drink/food together with white     bread and determine the glycaemic response. The GI of bread will be determined initially as a     reference.      Analysis will be done by measuring blood glucose response to white bread alone as reference     and then to white bread with test sample containing polyphenols and then determine GI and see     how the GI of bread will be affected. Other analyses to be done are plasma insulin, glucagon,     gastric inhibitory polypeptide (GIP) and glucagon like peptides-1 (GLP-1) as they all relate     to glycaemic response.      Study hypothesis is that glucose metabolism will be affected.      NOTE:        1. Only healthy participants undertook the study (Hence metabolic syndrome participants not          part of the study)        2. Only glucose and insulin were analysed in the plasma (hence GIP, GLP-1 and glucagon not          part of end points)   "
98710|NCT01994122|"     The purpose of this study is to examine differences in selected psychiatric/psychological     variables between a sample of unemployed young adults who have dropped out of high school and     a sample of college students.   "
98711|NCT01994109|"     This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea     (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected     directly into the salivary glands. MYOBLOC has been shown in previous trials to safely     decrease saliva production, thereby demonstrating its potential as a safe and effective     treatment for troublesome sialorrhea.   "
98712|NCT01994096|"     Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the     presence of risk factors. It is known that in critically ill patients, alterations in     function of various organs and body systems can influence the pharmacokinetics and hence the     plasma concentration of a drug. A study of caspofungin in ICU patients has found a high     inter- and intra-individual variability in caspofungin concentration. Factors that caused     subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and     hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin     among patients with a higher disease severity score.      As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur     in critically ill patients and an adjusted dosage might be necessary in these patients.   "
98713|NCT01994083|"     The purpose of this study is to investigate the safety and tolerability of IX-01 after     multiple doses, and to determine how the body handles IX-01.   "
98723|NCT01993953|"     This study is a four armed randomized controlled trial (RCT) where the main purpose is to     investigate the effect on muscle strength and changes in body composition in overweight (BMI     ˂ 25) not regularly exercising women aged 18-65, after 12 weeks of Body Pump (BP), compared     with an inactive control group. The study will also measure energy expenditure during one     session of BP. At the same time, the project will investigate the effect on muscle strength     and changes in body composition in group training with, respective without, a personal     trainer (PT).      H0: There`s no different between the groups after 12 weeks of Body Pump and traditional     strength training with and without a personal trainer on muscle strength and muscle mass in     adult overweight females.      H1: There is a different between the groups after 12 weeks of Body Pump and traditional     strength training with and without a personal trainer on muscle strength and muscle mass in     adult overweight females.   "
98724|NCT01993940|"     The purpose of this study is to evaluate the efficacy and safety of naldemedine in the     treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who     are not using laxatives.   "
98753|NCT01993563|"     The aim of the study is to evaluate whether a graded rehabilitation approach including     Implicit and explicit motor imagery training and mirror therapy is more effective than other     treatments commonly provided in a neuro-rehabilitation department.   "
98754|NCT01993550|"     The goal of this project is to examine the physical and psychological health benefits of a     novel, telephone-delivered symptom management intervention for advanced lung cancer patients     and their family caregivers.   "
98714|NCT01994070|"     Atrial fibrillation (AF) is the most common type of irregular heartbeat in emergency     department (ED) patients. If the irregular heartbeat has been present for less than 48 hours,     there is a chance that emergency treatment can convert the heartbeat into normal rhythm.      There are currently two options for accomplishing this; both are widely and safely used in     EDs. Each has its advantages and disadvantages. This study will compare the two methods. (1)     Patients are given an intravenous medication called procainamide; this converts patients into     a normal heart rhythm around 50% of the time. (2) Patients are sedated (put to sleep with a     general anesthetic) for about ten minutes, while an electrical current is conducted across     the chest; this converts patients into a normal heart rhythm around 90% of the time.      Procainamide can cause low blood pressure in about 10% of patients; this is usually corrected     by administering intravenous fluids. Sedation can cause low blood pressure in about 10% of     patients, and breathing trouble in about 10% of patients; this is usually corrected by     administering intravenous fluids, and administering more oxygen, respectively. In thousands     of patients studied around the world, there does not appear to have been a reported stroke or     death as a result of these procedures.      A physician will choose one method, but if it fails, will move to the next method. There are     thus two options. (1) Chemical conversion, followed by electrical conversion; and (2)     Electrical cardioversion, followed by chemical cardioversion. These options both have a 90%+     chance of converting AF into a normal heart rhythm. However, the investigators believe that     an electrical-chemical sequence will be faster than a chemical-electrical sequence, while     both will be equally safe.      If patients agree to take part in the study, they will be randomized to one of the two     options. They will have their breathing, oxygen levels, blood pressure, and heartbeat     monitored for their entire ED stay.      The investigators plan to enrol 86 patients at five hospitals over the course of about one     year. The primary outcome of ED length-of-stay, as well as secondary outcomes, such as     conversion to normal rhythm, and adverse events (such as trouble breathing or low blood     pressure) will be documented. In addition, an investigator will contact you at three and     thirty days after your visit to make sure that there are no problems. Importantly, although     the principal and site investigators will be aware of the primary outcome, attending     emergency physicians who actually provide patient care will NOT be aware of the primary     outcome--otherwise this could bias patient management.      When the study is finished, the results will be given to the writing committee merely as the     A and B arms, and not specified as either the chemical-first or electrical-first     arms. The writing committee will compose two manuscripts, (1) assuming that A is the     chemical-first arm and B the electrical-first arm, and (2) assuming that A is the     electrical-firstarm, and B the chemical-first arm. After both manuscripts have been     approved by all authors, the blinding will be removed and only the correct manuscript     submitted for publication.   "
98715|NCT01994057|"     For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy     has been widely accepted since the success of crizotinib administration based on EML4-ALK     fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive     mutations.From clinical points of view ,individual differences often occur between different     patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and     adverse drug reaction was significantly influenced by the pharmacokinetic factors and     pharmacodynamic factors.In this research ,we try to establish a more sensitive method to     detect sensitive mutations in plasma and discover the correlation between somatic and     germline mutations , trough concentration and EGFR-TKI drug effect, the association between     ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo     and in vitro research is also crucial for rational explanation for these clinical phenomenon.   "
98716|NCT01994044|"     Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some     may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task     Force (2008) found no existing evidence for positive effects of fusion operations in such     patients. Some of them, however, present with symptoms that might indicate pain from a motion     segment, possibly the disc. Our aim was therefore to test this possibility by performing a     randomized study comparing cervical fusion and multimodal rehabilitation in chronic WAD     patients.      Methods: Patients with a specified symptomatology, all with pronounced symptoms for long     periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal     rehabilitation (24 pat.). All patients were investigated before start of the study and at     follow-up approximately two years after treatment by four independent examiners from     disciplines usually involved in treating WAD patients. The patients also gave their own     assessments of the treatment results. Seven patients in each group did not undergo the     allocated treatment for various reasons.   "
98717|NCT01994031|"     The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel     liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome     injection and paclitaxel injection and to value the effectiveness for cancer treatment.   "
98718|NCT01994018|"     The correlation between relapses in MS and vitamin D intake will be examined.   "
98719|NCT01994005|"     The scope of this project was to provide evidence that better contraceptive choices are made     with more effective counseling as well as improvement in patients' contraceptive knowledge.     Specifically we wanted to evaluate the use of social media as a means for effective patient     counseling.   "
98720|NCT01993992|"     Post-operative delirium had multiple risk factors, such as pre-operative anxiety status,     post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by     parental accompanying until the children put to sleep. However, references indicate that     parental anxiety can increase the post-operative delirium. Heart rate variability was used to     measure the anxiety status of parents. We think sympathetic tone elevation measured by heart     rate variability may not induce by anxiety alone, thus we want to explore this question by     using Stat-Trait Anxiety Inventory questionnaire.   "
98721|NCT01993979|"     POUT is a multi-centred randomised controlled phase III trial. 345 patients who have     undergone nephro-ureterectomy, are surgically staged pT2-pT4, N0-3 or are pT1 and node     positive, and who are fit for adjuvant chemotherapy, will be randomised to four cycles of     adjuvant platinum based chemotherapy (experimental group) or surveillance (control group).     Participants will be followed up according to routine practice.      Primary endpoint: Disease-free survival (DFS)      Secondary endpoints:        -  Overall Survival        -  Metastasis free survival        -  Incidence of bladder second primary tumours        -  Incidence of contralateral primary tumours        -  Acute and late toxicity        -  Treatment compliance        -  Quality of life   "
98722|NCT01993966|"     Urothelial carcinoma (UC) is the most common cancer of urinary tract. Patients with     metastatic UC are usually treated with systemic chemotherapy. There still existed 30% to 50%     of advanced UC not responsive to cisplatin-based chemotherapy; the prognosis for patients     with metastatic UC remains poor.   "
98725|NCT01993927|"     To determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent     progression to type 2 diabetes mellitus in patients with impaired glucose tolerance in the     routine clinical setting.   "
98726|NCT01993914|"     The etiologies of varicose veins and the progression to more serious forms of chronic venous     disease and identification of appropriate diagnostic tests to better aid patient management     by identifying individuals who may benefit from more aggressive treatment and/ or     prophylactic measures.   "
98780|NCT01993212|"     This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men     with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm     Concentration Following Treatment with the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.   "
98734|NCT01993810|"     This randomized phase III trial studies proton chemoradiotherapy to see how well it works     compared to photon chemoradiotherapy in treating patients with stage II-III non-small cell     lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a     high dose of radiation directly to the tumor, such as photon or proton beam radiation     therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in     chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon     chemoradiotherapy in treating non-small cell lung cancer.   "
98735|NCT01993797|"     To evaluate the correlation between clinical and ultrasound findings in children presented     with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis     that will correlate with specific clinical outcomes.   "
98736|NCT01993784|"     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in     the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     efficacy has been shown in adult with head and neck cancer. The study assessed the safety and     efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients     with locally advanced or metastatic esophageal squamous cell carcinomas.   "
98737|NCT01993771|"     This is a prospective, observational study, aimed to establish changes of bispectral     bilateral system in both cerebral hemispheres during a total intravenous anaesthesia during     breast surgery in the woman. By placing two Bispectral bilateral sensors (BIS), one on both     frontal lobes, and another on both parietal lobes, we wanted to evaluate differences between     frontal and parietal areas, when the patient is awake and during the anaesthetic procedure.   "
98738|NCT01993758|"     This study aims to determine whether the lower tourniquet pressure, which is set by adding     120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet     inflation, are efficient and safe during total knee arthroplasty, compared with the     conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet     inflation.   "
98739|NCT01993745|"     The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in     critical illness patients   "
98740|NCT01993732|"     The purpose of this study is to retrieve and cryopreserve ovarian tissue from females     undergoing a treatment that may lead to irreversible loss of ovarian function.   "
98741|NCT01993719|"     Background:        -  The NCI Surgery Branch has developed an experimental therapy that involves taking white          blood cells from patients' tumors, growing them in the laboratory in large numbers, and          then giving the cells back to the patient. These cells are called Tumor Infiltrating          Lymphocytes, or TIL and we have given this type of treatment to over 400 patients with          melanoma.        -  In this trial, we are determining if there is a difference in the response between          patients who have received prior anti-PD1 treatment to those who have not received this          prior ant-PD1 treatment.      Objectives:      - To determine if there is a difference in the rate of response between patients who have     received prior anti-PD1 and those who have not.      Eligibility:      - Individuals at least 18 years and less than or equal to 70 years of age who have metastatic     melanoma.      Design:        -  Work up stage: Participants will be screened with a physical exam and medical history.          Blood and urine samples will be collected.        -  Surgery: Surgery or biopsy will be performed to obtain tumor from which to grow white          blood cells. White blood cells will be grown from the tumor in the laboratory.        -  Leukapheresis: Participants will have leukapheresis to collect additional white blood          cells. (Leukapheresis is a common procedure which removes only the white blood cells          from the patient.)        -  Treatment: Participants will receive standard dose chemotherapy to prepare their immune          system to accept the white blood cells. Participants will receive an infusion of their          own white blood cells grown from tumor. They will also receive aldesleukin for up to          five days to boost the immune system s response to the white blood cells. They will stay          in the hospital for about 4 weeks for the treatment.        -  Follow up: Patients will return to the clinic for a physical exam, review of side          effects, lab tests, and scans about every 1-3 months for the first year, and then every          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2          days.   "
98748|NCT01993628|"     Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative     pathologies. They differ in their expression, their evolution but share same features which     make their diagnosis uneasy.      Constructional apraxia has been described in both disease.The underlying mechanisms have been     less studied and could be different in AD and LBD.      The definition of the constructional apraxia is purely descriptive and few models are     inconclusive.      It is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities,     executive functions and working memory as well as purely constructive skills.      Regarding to different studies, visuo-perceptive abilities are more severely impaired in LBD     than in AD and are considered as an early onset sign of the disease.      Executive functions deficits are documented in AD and LDB and could contribute to the drawing     impairment.      It is possible to compensate the planning disorders in giving patient the best strategy to     use.      If drawing impairment persists, they should result of others mechanisms like     visuo-perception, visuo-spatial or constructive deficits.      The investigators suggest that giving the best planning strategy will help more AD patients     who are supposed to fail in raison of an executive impairment, than the LDB group who is     supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral     areas involved in constructional apraxia.   "
98742|NCT01993706|"     Background:      - VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV).     Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or     treat HIV infection. In this study they want to know if the study drug is safe if taken in a     vein or under the skin. Taking VRC01 in this study will not protect against HIV infection.      Objectives:      - To see if VRC01 and placebo are safe and well tolerated.      Eligibility:      - Healthy adults 18 to 50 years old.      Design:        -  Participants will be screened with medical history, physical exam, and lab tests.        -  Participants will be randomly divided into 4 groups. VRC01 or the placebo will be given          in weeks 1 and 4. Blood samples will be taken several times after each VRC01 or placebo          dose.        -  Three groups will receive VRC01 by needle into a vein with an IV pump. It will take          about 1 hour and it is done in the hospital.        -  One group will receive either VRC01 or the placebo by needle into the fatty tissue under          the skin, usually the belly. It will take up to 20 minutes and it is done in the          hospital.        -  Participants will stay in the hospital overnight after receiving the medication and have          about 14 clinic visits over 4 months. Most clinic visits last about 2 hours.        -  Participants will keep a symptom diary after receiving the medicatino.        -  Participants can volunteer to have mouth, rectal, and genital samples taken throughout          the study.        -  The study will last 8 months.   "
98743|NCT01993693|"     The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound     device to reduce pain and increase mobility for subjects with knee osteoarthritis.   "
98744|NCT01993680|"     Disabling symptoms of blood pressure dysregulation, impaired swallowing and digestion are     common amongst Parkinson`s patients. So far the exact pathophysiology for this is not fully     understood. There are results from pathological analyses that the autonomic nervous system is     also affected by the accumulation of alpha-Synuclein and that this might even happen in very     early stages of the disease process (Qualman et al., 1984; Wakabayashi et al., 1989;     Wakabayashi et al., 1990; Bloch et al., 2006).      Blood pressure dysregulation is a common autonomic symptom in Parkinson`s patients and     treatment - currently most often achieved with Fludrocortisone - often leads to supine     hypertension (Plaschke et al., 1998; Braune et al., 1999; Magerkurth et al., 2005).      There are studies in patients with autonomic failure that indicate that Pyridostigmine     bromide might be an alternative treatment option without causing disabling supine     hypertension (Singer et al., 2003; Sandroni et al., 2005; Singer et al., 2006; Yamamoto et     al., 2006).      Delayed gastric emptying is also an autonomic symptom associated with Parkinson`s disease. By     the elevation of the cholinergic tone with Pyridostigmine bromide the investigators also     expect to alleviate symptoms of delayed gastric emptying and obstipation, possibly even     facilitating the uptake of dopaminergic medication through the gut (Sadjadpour, 1983;     Bharucha et al., 2008).      Therefore the investigators designed a monocentric randomized, controlled, double blind,     crossover phase II trial to show non-inferiority of the effect of pyridostigmine bromide vs.     fludrocortisone on symptoms of autonomic dysregulation in Parkinson`s disease.   "
98745|NCT01993667|"     Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude     illness. The medication is effective in preventing acute mountain sickness (AMS), high     altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is     via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis     which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the     urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude     disorders.      Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to ascending     in elevation. Side effects include tingling of the fingers and toes and perioral numbness     which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a mild     diuretic, frequent micturition may occur leading to interruption of daytime activities as     well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is     normally discontinued 2 days after the user has reached their highest elevation or a plateau     in elevation.      A lower dose may be just as effective in preventing high altitude illnesses while preventing     the disconcerting side effects resulting from its use. A smaller dose has not been studied,     however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg     twice daily.   "
98746|NCT01993654|"     This study aims to validate the use of laser in vivo confocal microscopy as an early     diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy     of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection     for early detection of tumor recurrence, and to evaluate the use of in vivo confocal     microscopy in evaluation of response to treatment. The modified technique with Heidelberg     Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography     (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of     benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired     melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in     vivo as preliminary studies have shown.   "
98747|NCT01993641|"     The purpose of this open label study is to determine whether combining pracinostat (study     drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in     Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent     hypomethylating agent (HMA), and to provide additional safety and efficacy data.   "
98749|NCT01993615|"     The purpose of this study is to compare the outcomes for patients that receive two different     treatments used for FAI (Femoroacetabular Impingement). The programs are 1) a 6-week     supervised physical therapy program and 2) arthroscopic surgery. Enrollment is limited to     patients that have already been determined surgical candidates. The study is following     patients for a 2-year period.   "
98767|NCT01993381|"     The most common toxicity of chemotherapy is nausea and vomiting, and appropriate management     of these toxicities can help patients improve tolerance for chemotherapy. Anti-emetics     including dopamine antagonist, serotonin antagonist, and substance P antagonist administered     to patients according to emetogenic risk of chemotherapeutic drugs. However, patients don't     always experience same nausea and vomiting for the same drugs. Therefore, it is important to     determine the biomarker to predict chemotherapy-induced nausea and vomiting. Some biomarkers     studies were done during the chemotherapy. However it is not definite evidence of relations     between biomarkers and chemotherapy. We will hope to find any predictive biomarker of CINV.   "
98750|NCT01993602|"     The lung expansion techniques are widely used to prevent postoperative pulmonary     complications. However, the effect of each technique on thoracoabdominal mechanics after     abdominal surgery and if it influences the rate of postoperative pulmonary complications     remains unknown. The investigators hypothesis is that the lung expansion technique that more     increases lung volume after abdominal surgery, will be the most efficient in preventing     postoperative pulmonary complication after abdominal surgery. The investigators objectives     will be to compare the effect of different lung expansion techniques on lung volumes and     activation of inspiratory muscle, and prevention of pulmonary complications in patients     undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective     abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35),     continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS,     n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The     thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications     will be evaluated by a researcher who did not know to which group each patient belongs.   "
98751|NCT01993589|"     Patients frequently experience pain from moderate to severe during gynecologic procedures.     This study is a prospective, randomized, placebo-controlled trial and aimed to investigate     the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous     paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage     procedure.   "
98752|NCT01993576|"     The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to     detect the margine of the breast tumoral tissue.   "
98755|NCT01993537|"     Patients will undergo at baseline and regular intervals:        -  clinically indicated bloodwork/urine and echocardiogram testing        -  biomarker studies      Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient     and severely deficient. Normal and mild vitamin D levels will receive no treatment while     severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D     treatment. They will be seen in the heart failure clinic every 6 months. The patients will be     followed for 26 months.   "
98756|NCT01993524|"     The purpose of this study was to determine whether supplementation of standard antibiotic     therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences     recurrence of bacterial vaginosis/vaginitis.   "
98757|NCT01993511|"     Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose     metabolism leading to remission of type 2 diabetes early after surgery. However the     mechanisms for this improvement remain uncertain. The aim of this study is to investigate the     changes in insulin sensitivity and beta-cell function 1 week and 3 months following RYGB     using oral and intravenous test.   "
98758|NCT01993498|"     The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to     generate predictors of chronic toxicity in patients with non-metastatic breast cancer.      The project will include four specific aims :        1. To develop a database of chronic treatment related toxicity in a cohort of 20 000 women          with stage I-III breast cancer (= non metastatic), whatever these treatments are          (surgery; radiation therapy; chemotherapy …)        2. To describe incidence, clinical presentation, and outcome of chronic toxicities over a          maximum of 8 years.        3. To describe the psychological, the social and the economic impacts of chronic          toxicities.        4. To generate predictors for chronic toxicities in order to prevent them, based upon          biological criteria.      The expected impact of these toxicities, when identified, will be to improve quality of life     and to decrease health cost, by the early identification of patients at high risk of     toxicity. Such early identification could lead to prevent toxic effect by: a. developing     prevention strategies, b. substituting toxic treatment by a non (less) toxic one.      Also, such cohort will offer a quantification of the impact of treatment toxicity, that could     be further used to quantify medical usefulness of strategies that aim at decreasing treatment     toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen     etc…)   "
98759|NCT01993485|"     Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with     a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the     8th decades. AVS is independently associated with atheroclerosis risk factors and clinically     apparent CV disease indicating that the degeneration of the aortic valve may represent an     atheroclerosis-like process involving both, the aortic valve as well as the vascular system,     respectivel. It is still unknown whether the endothelial function is affected as an     manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS     downstream of the valve, or other factors beyond physical pressure effects.      The investigators hypothesized that altered haemodynamics may at least partly be responsible     for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study     is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI)     affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as     markers of endothelial integrity.   "
98760|NCT01993472|"     The purpose of this study is to determine the efficacy and safety of Andrographolides     combined with Capecitabine in treatment of elderly patients with locally advanced or     recurrent or metastasis inoperable colorectal cancer   "
98761|NCT01993459|"     The purpose of this study is to determine whether Midazolam given pre-operatively to patients     undergoing abdominal surgery improves the quality of recovery.   "
98762|NCT01993446|"     The purpose of this study is to determine whether DRM02 is safe and effective in the     treatment of rosacea when applied twice daily for 6 weeks.   "
98763|NCT01993433|"     The purpose of this study is to determine whether DRM02 is safe and effective in the     treatment of plaque psoriasis when applied twice daily for 6 weeks.   "
98764|NCT01993420|"     The purpose of this study is to determine whether DRM02 is safe and effective in the     treatment of atopic dermatitis when applied twice daily for 6 weeks.   "
98768|NCT01993368|"     Periodontitis are inflammatory diseases characterized by the destruction of the     tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are     described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the     severity and rapidity of bone loss, much more important for AP than CP. In both forms, the     link with uncontrolled activation of the immune system is largely admitted. Despite the     physiopathology of CP is fairly well studied, very few data are available regarding AP. The     investigators aim is to understand the severity of AP by analyzing the proportion and action     of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of     periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will     be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).   "
98769|NCT01993355|"     Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes     for patient disability and a general recurrent cause for medical consultation with high costs     to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although     this treatment is aimed to reduce disability, pain severity and pain-related     anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive     and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of     this pathology that takes into account psychosocial aspects that might be modulating pain is     necessary.      Material and methods: This project aims to assess the efficacy of two complementary     interventions to standard physical therapy, such as relaxation techniques and     cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among     patients with CLBP. It is hypothesized that groups receiving these complementary     interventions will significantly improve their adherence to physiotherapy and the control of     their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and     better HRQoL.      For these purposes, a pre-post longitudinal design will be carried out, with follow-up     assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided     into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation     techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral     intervention).      Expected impact: Study results are not available yet. However, if working hypotheses are     confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This     approach is expected to benefit HRQoL among these patients implying a significant short-mid     term reduction of public health costs.   "
98770|NCT01993342|"     The purpose of this study is to determine the concentration of different adipocytokine     (adiponectin, leptin, resistin, visfatin, osteopontin) and an inflammation classic markers as     Interleukine 1 beta, tumor necrosis alfa, interleukine 6 and high sensibility reactive c     protein in the synovial fluid of knee osteoarthritis patients, and compare with the     inflammation detected with ultrasonography evaluation of the joint. In last years, some     studies appeared focusing on the role of adipocytokines in osteoarthritis and they correlated     adipocytokines with cartilage degradation and x-ray degree; in our study we will focused in     the importance of adipocytokines in the inflammatory changes more than in joint destruction.   "
98771|NCT01993329|"     This is a randomised, double blind, double-dummy, placebo-controlled, three way crossover,     single centre study in subjects with asthma undergoing inhalation of methacholine and ATP to     assess the PC20 response of two dose levels of gefapixant (AF-219) compared with placebo.   "
98772|NCT01993316|"     Neurofeedback can be described as a form of biofeedback which is based on recording brain     activity; usually by using scalp EEG. Neurofeedback has been used for 40 years as a     therapeutic treatment for many neurological conditions including epilepsy, attention deficit     hyperactivity disorder and also to improve mental performance in healthy subjects.     Participants can see their brain activity via the EEG readings and receive positive     feedback (visual or auditory) to help them consciously shape their brain waves into the     desired patterns.      sLORETA, which is speciliazed computer program to analyze EEG results, will be used in     conjuntion with EEG to study the effect of neurofeedback on the brain activity of healthy     subjects.      In this study we will investigate the effect of neurofeedback training using sLORETA, which     is a specific method to measure brain waves. We will measure the effect on both brain     hemispheres both before and after neurofeedback training.   "
98773|NCT01993303|"     Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure and     extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D Rb-82     PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (~20 mCi) processed     using a Monte-Carlo driven scatter correction algorithm against conventional higher dosage     (~50 mCi) 2D Rb-82 PET MPI.   "
98774|NCT01993290|"     Ultrasound-guided (USG) brachial plexus (BP) block efficacy at the Supraclavicular (SCL),     Lateral- Infraclavicular (LIC) and Axillary (AX) level: Randomized, observer-blinded study of     the single-penetration multiple-injection-technique.   "
98775|NCT01993277|"     The study is an open-label comparative effectiveness clinical trial evaluating the impact of     three neuromodulation treatment devices to improve the mental health and sobriety status of     recovering substance abuse patients. We intend to enroll 200 patients to give us a sufficient     number of subjects for the planned comparisons. Following informed consent and baseline     assessment, patients will be randomly assigned to receive either 1) 15 40-minute sessions of     Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device, once-per-day within     a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace Stimulator, another CES     device, twice-per-day within a 3-week time-frame; 3) 15 40-minute sessions of the DAVID     Delight, an audio-visual stimulation device (AVS), once-per-day within a 3-week time-frame;     OR 4) the control-group condition of 15 40-minute relaxation therapy sessions once-per-day     within a 3-week time-frame. All subjects will then be reassessed at the end of the 3 weeks of     treatment and again 1, 3, and 6 months later. In addition to the assigned treatments, all     patients will also receive the standard array of services that are provided by Behavioral     Health of the Palm Beaches (BHOPB) including as clinically appropriate, psychiatric     medication management and Eye Movement Desensitization Response (EMDR) therapy. Patients     diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed to determine their     suitability for EMDR and if suitable, will receive 2 or more EMDR sessions. Patients without     PTSD do not receive EMDR therapy.   "
98776|NCT01993264|"     Cardiac disease in children may start early in life and evidence of cardiac disease can be     seen during prenatal life. A variety of diseases diagnosed during fetal life can put children     at risk for cardiac disease. The accurate assessment of cardiac function is important in     these patients. A type of imaging scan called fetal echocardiogram is used to measure the     contractility or squeeze of the heart. The fetal echocardiogram is a painless test and     completely non-invasive.      This study aims to recruit women and fetuses to determine if this imaging scan can be used     throughout the pregnancy to measure heart squeeze and develop normal values to help doctors     better diagnose fetuses who may have cardiac disease before they are born.   "
98777|NCT01993251|"     Although behavioral disorders origins in autistic children are still unclear, they seem to be     influenced by sleep disorders. Results of studies performed on sleep quality in autistic     children showed a high prevalence of sleep disorders in these children, estimated between 50     and 80% compared to children with typical development and insomnia is one of the sleep     disorders most frequently reported by autistic children's parents. Others studies showed     circadian rhythm disorder in autistic children which could be the consequence of genetic     abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission     modulation.      Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of     sleep proposed for insomnia treatment and circadian rhythm disorders.      Two major recent studies (not yet published) in the United States and in England seek to show     the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing     sleep disorders.      It is therefore interesting and important to conduct a parallel study to assess the melatonin     effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…),     but on sleep quality (number of nocturnal awakenings).      The strength of this study lies in the combination of several measurement tools to assess the     melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography),     biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of     insomnia severity, rating scale autistic disorder) as well as possible side effects.      The primary objective is to determine the most effective dose of melatonin to improve sleep     quality in autistic children.   "
98778|NCT01993238|"     The objectives of this study are to evaluate the safety and effectiveness of procedural     analgesia for improvements in tolerability of treatment with the Liposonix System.   "
98779|NCT01993225|"     This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men     with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm     Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.   "
98781|NCT01993199|"     Upper gastrointestinal subepithelial tumors are frequently encountered during     esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by     algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography     alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient     accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of     subepithelial tumors.      Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection     technique and multiple endoscopic biopsies were performed.      The investigators will perform deep biopsy in subepithelial tumor.   "
98782|NCT01993186|"     UX007 is more effective than placebo for the reduction of seizures in patients with Glut1 DS,     as measured by the reduction from baseline in frequency of generalized or partial-onset     seizures, including: Generalized Tonic-Clonic, Generalized Tonic, Generalized Clonic,     Generalized Atonic, Partial/Focal with Secondary Generalization, Myoclonic, Myoclonic Atonic,     Myoclonic Tonic, Complex Partial/Focal, Absence and Simple Partial/Focal Motor seizures   "
98783|NCT01993173|"     The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to     local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in     participants in China.      Primary objective:        -  To describe diphtheria and tetanus seroprotection rates and pertussis booster response          rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups),          local DT vaccine (in children), and local Td vaccine (in adolescents and adults).      Secondary Objectives:        -  To further describe in each group the immunogenicity of the study vaccines at baseline          and 1 month after vaccination.        -  To describe the safety of the study vaccines   "
98784|NCT01993160|"     This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging     patients with high risk prostate cancer.      Study Hypothesis:      FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as     compared to conventional imaging.   "
98785|NCT01993147|"     The purpose of this study is to learn more about the brain circuits involved with effortful     control in healthy adult participants. Study participants will be given either     methylphenidate (also known as 'Ritalin')which is an FDA approved, most widely-used     medication given to those diagnosed with Attention Deficit Hyperactivity Disorder (ADHD)or a     placebo, which is a sugar pill. Each participant will also perform some computer tasks that     have been shown in previous studies to require effortful control while undergoing an fMRI     (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain.     Our goal is to learn more about the brain mechanisms by which methylphenidate improves     effortful control.   "
98786|NCT01993134|"     The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients     with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology     services of the Onofre Lopes University Hospital attached to the Federal University of Rio     Grande do Norte.   "
98787|NCT01993121|"     The objective of the current proposal is to evaluate the importance of blood vessel     dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and     their contribution to the gender differences observed in exercise capacity. Importantly,     treatments that improve blood vessel function in persons with type 2 diabetes can be used to     directly assess whether impairment in blood vessel function and ultimately exercise     performance, can be improved and whether the degree of improvement differs between the sexes.      Hypothesis 1. Uncomplicated type 2 diabetes more adversely affects exercise capacity in women     than men.      Hypothesis 2. Blood vessel function and cardiac function are more significantly impaired in     women with type 2 diabetes than men and contribute to the gender differences in exercise     capacity.      Hypothesis 3. Restoration of blood vessel function will improve exercise capacity more in     women than men with type 2 diabetes.   "
98838|NCT01992458|"     The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention     of sudden cardiac death has been introduced later in France than in other parts of the World.     Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.   "
98788|NCT01993108|"     The goal of this research is to understand the functioning of 'regulatory circuits' in the     brain. These are brain circuits which allow a person to regulate their attention, regulate     their behavioral responses, and regulate their decision-making. We are also interested in how     the stimulant medications methylphenidate and naltrexone affect these regulatory circuits.     Methylphenidate is a widely-used, FDA approved medication used to treat Attention Deficit     Hyperactivity Disorder (ADHD) and is also known as Ritalin. Naltrexone is an FDA approved     medication used to help treat alcohol and substance abuse.      This research study will use a scanning technique known as functional magnetic resonance     imaging (fMRI)which takes a special kind of picture of the brain that enables us to see the     brain at work. Adult participants will be given a one-time dose of either methylphenidate,     naltrexone,or placebo before each fMRI scan session. There are three total fMRI scan     sessions. Therefore, each participant will receive each possible medication/placebo only     once.      Thus, using the fMRI technique, our main purpose for this research is to better understand     the functioning of regulatory circuits in conditions such as ADHD and alcohol dependence.     This research may one day help us develop better treatments for these disorders.   "
98789|NCT01993095|"     The purpose of this study is to test the effectiveness of a DVD-delivered, home-based     six-month physical activity intervention for people with Multiple Sclerosis.   "
98790|NCT01993082|"     The purpose of this study is to determine whether an aerobic training intervention will alter     markers of immune cell aging, improve exercise capacity and blood pressure and decrease     psychological distress over 24 weeks in 32 caregivers compared to 32 age-matched wait list     control caregivers.   "
98809|NCT01992835|"     After an allergen challenge, the allergic inflammatory response disappears spontaneously. The     initiation of the resolution of the inflammatory response is now recognized as a dynamic     process, involving active biochemical programs that enable inflamed tissues to return to     homeostasis. Recent data established key roles of different specific lipid mediators in the     endogenous counter-regulation of inflammation and activation of resolution. Only little is     known about kinetics of these specialized pro-resolving lipid mediators during acute allergic     inflammation. Therefore, the primary propose of our study is to characterize the temporal     evolution of cellular inflammation and specific lipid mediators after allergen challenge.   "
98791|NCT01993069|"     The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with     mild post-traumatic and chronic tension-type headaches.      Study Aims:        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild          post-traumatic and chronic tension-type headaches experience, assist in decreasing          headaches and associated symptoms?        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild          post-traumatic and chronic tensions-type headaches experience, assist in improving          quality of life?        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild          post-traumatic and chronic tension-type headaches experience, improve mood?        -  Do the effects of yoga on symptoms, mood, and quality of life maintain 2 months post          completion of treatment?   "
98792|NCT01993056|"     According to available data the injury rate in male veteran soccer is high. Interventions to     prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and     consists of several exercises with an overall-length of about 20 min. This study shall     investigate the influence of 11+ on injury incidence and Functional Movement Screen     (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a     relationship between FMS-Score and injury incidence. For this purpose the 11+-program is     accomplished under supervised conditions over one regular season in a randomized-controlled     study design. Injuries are documented via questionnaires in accordance with the     FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.   "
98793|NCT01993043|"     Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular     endothelium growth factor (VEGF) is an important component of this disease. The goal of     treatment is to reduce the production of VEGF in the immature retina and to eliminate the     abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral avascular     retina is the treatment standard. Intravitreal injection of anti-VEGF antibody Bevacizumab     (IVB) has been used clinically off-label as an alternative therapy. However, VEGF is     important for the development of neurons and vessels in the systemic organs in premature     infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream. It is     unclear if the systemic absorption of Bevacizumab is dose related, and the short and longterm     effects on ocular and systemic systems, especially neurological development. In this study,     our goals are to establish the pharmacokinetics of Bevacizumab in the premature infant and to     compare the short and long-term vision and neurodevelopmental outcomes of infants treated     with IVB compared to laser ROP.   "
98794|NCT01993030|"     The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical     Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix     Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.   "
98795|NCT01993017|"     The purpose of this study is to examine, in a randomized controlled trial, the benefits and     costs of the American Heart Association's (AHA) advisory for depression screen and treatment     of post-acute coronary syndrome patients.   "
98796|NCT01993004|"     MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in     many human diseases. The purpose of this pilot study is to determine if microRNA expression     is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis.   "
98797|NCT01992991|"     The purpose of this study is to investigate the effect of transcranial stimulation for upper     limb training of patients with sequelae from an intracranial hemorrhage.      Patients receive five days of upper limb occupational therapy training in combination with     real or sham stimulation. Patients complete the Jebsen Taylor Hand Function Test before,     after and 7 days later. The intervention takes place at patients' home address.   "
98798|NCT01992978|"     Surgical resection is the most effective treatment of primary and secondary liver tumors.     Technical innovations have mainly focused on minimizing bleeding during transection of the     hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are     associated with increased postoperative morbidity and mortality.     Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread     acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the     prognosis of HCC patients，especially for those with cirrhosis，is still controversial.     Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy     versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of     HCC patients with cirrhosis.   "
98799|NCT01992965|"     The purpose of the study is to evaluate the effect of real-time continuous glucose monitoring     system on glucose control and outcomes of critically ill patients.   "
98839|NCT01992445|"     Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated     suicide attempt.   "
98800|NCT01992952|"     This is a two stage study, with an initial dose escalation phase I study and subsequent     double blind randomised phase II controlled trial. Eligible patients are post-menopausal     women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should     be suitable for endocrine treatment, but have received no more than 3 previous lines of     endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also     have had progressive disease during treatment with an aromatase inhibitor. Following the     dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either     placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once     daily.      Patients will receive fulvestrant in combination with either placebo or AZD5363 until disease     progression. Patients may continue to receive fulvestrant and AZD5363/placebo treatment even     after the last trial visit.   "
98810|NCT01992822|"     The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the     clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists in     the evaluation of the experimental sensitivity to mechanical pain (pressure application on     the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21 days),     and to put the results in relation to the clinical improvement and the psychometric     evaluations (depression,fibromyalgia impact questionnaire, catastrophism).   "
99092|NCT01989104|"     The purpose of this study is to measure and link cadence (number of steps taken in a minute)     to intensity of physical activity (e.g., low-intensity, moderate-intensity,     vigorous-intensity) in children and adolescents (6-20 years-old), and to identify the cadence     values corresponding to children's and adolescent's behavior during simulated free-living     activities.   "
98801|NCT01992939|"     This is the second part of a research study in order to determine if using a specialized     pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and     heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD),     vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and     pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled.     SaO2 and pulse readings are important to maintain patient stability during diagnostic     testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2 and     pulse are important to monitor in order to be able to compensate for any decrease in patient     oxygen saturations during hemodynamic monitoring.      The primary aim of this study is to determine if using a specialized pulse oximetry probe     with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse     readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to     readings obtained from an arterial blood gas.      The hypothesis is using a specialized pulse oximetry probe with external heat pack will help     obtain more accurate pulse oximetry readings consistent with values obtained with an arterial     blood gas.   "
98802|NCT01992926|"     Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney     disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise     and fatigue. The current accepted practice is often to administer erythropoietin-stimulating     agents (ESAs), which act like the body's natural hormones to stimulate the production of red     blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests     that they are not as safe as previously thought. In this study, we seek to test a decision     aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of     the decision aid is to reduce patient confusion, improve their satisfaction with their care,     improve their knowledge of kidney disease, and ultimately bring more clarity to patients     about a controversial but ubiquitous drug.      The decision aid will be about 1 page long and will include questions and information that     might help the patient be more active and informed regarding the choice of a course of ESA     therapy. We will ask patients to answer questions before and after their clinic visits     regarding their satisfaction and confidence in their treatment and their knowledge of kidney     disease; we will ask some of the same questions 3 months after the clinic visit. We will     compare patients who are counseled using the decision aid to patients who are not. We     anticipate total experiment running time to be approximately 5 months to recruit and follow     up on all patients.   "
98803|NCT01992913|"     Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive     skills, social skills, and functional skills (like employment). There is a new form of     cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that     specifically addresses the cognitive, social, and functional deficits of     schizophrenia/schizoaffective disorder. This study is to compare iCBT to the usual care (UC)     that Veteran's receive. The investigators will compare iCBT to UC in subjects with     schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE)     program, and evaluate whether iCBT is more helpful in improving job performance, and other     areas of functioning, both right after treatment, and 6 months after the end of treatment.   "
98804|NCT01992900|"     There is a need for paediatric formulations that permit accurate dosing and enhance patient     compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations     are available on the market. Thus, a new water dispersible formulation of eurartesim has been     developed for oral administration.      Aim of this study is to provide data on pharmacokinetic profile, safety and efficacy of this     new paediatric formulation and compare it with the crushed film coated tablet in infant     patients (6 to ≤12 months of age) suffering from uncomplicated Plasmodium falciparum malaria.      Furthermore, a Pharmacokinetic/Pharmacodynamic(PK/PD) modelling will be built up to establish     PK/PD relationship in adult and paediatric populations.   "
98805|NCT01992887|"     Retention of patients in HIV care following diagnosis and enrollment is critical to the     long-term success of HIV care and treatment scale-up. The goal of this study is to better     understand the factors that influence retention and engagement in HIV care among adult     patients who are enrolled in HIV care and are not yet eligible for antiretroviral therapy     (ART). The study will be conducted at four HIV care and treatment clinics (CTCs) in Kagera     Region, Tanzania. This is a mixed-methods study with both qualitative (interviews) and     quantitative (surveys) data collection. Our findings will be important towards designing     programs that help patients remain in HIV care.   "
98806|NCT01992874|"     This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over     trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in     cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial     extension phase).   "
98807|NCT01992861|"     This clinical trial studies magnetic resonance imaging (MRI) and positron emission tomography     (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer.     MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used     to create detailed pictures of areas inside the body. PET is a procedure in which a small     amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make     detailed, computerized pictures of areas inside the body where the glucose is taken up.     Comparing results of diagnostic procedures, such as MRI and PET, done before, during and     after radiation and chemotherapy may help doctors predict a patient's response to treatment     and help plan the best treatment.   "
98808|NCT01992848|"     Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an     estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with     atherosclerotic plaque burden and cardiovascular mortality. Mechanisms underlying isolated     CAC have not been as yet been fully explained. MicroRNAs (miRNAs), known to act as regulators     of gene expression, have also emerged as powerful biomarkers in the diagnosis and prognosis     of cardiovascular disorders and may be used in the detection of CAC. We aim to investigate     the potential for a microRNA-signature in patients with CAC by performing a prospective,     case-controlled study to identify pathways associated with CAC in humans. Previous research     has demonstrated an inverse relationship between CAC and bone mineral density (BMD),     suggesting that these processes may be linked. In a further substudy we plan to define the     relationship between CAC and BMD as well as a number of markers of bone metabolism.   "
98811|NCT01992809|"     Nonalcoholic fatty liver disease (NAFLD) is a clinical and pathological condition, whose     spectrum can range from steatosis to steatohepatitis and cirrhosis, in patients without a     history of alcohol abuse. Nonalcoholic steatohepatitis (NASH), the severe form of (NAFLD),     has emerged as a clinically important type of chronic liver disease in industrialized     countries and is characterized pathologically by hepatocellular ballooning, Mallory's     hyaline, scattered inflammation and perisinusoidal fibrosis. NASH associated with cirrhosis     can decompensate into subacute liver failure, progress to hepatocellular cancer and reoccur     post transplantation.In the absence of established treatment, therapy is generally directed     to treatment of risk factors for metabolic syndrome. Recently, some studies have been     demonstrated that Polyunsaturated fatty acids (PUFAs), omega3 type, could reduced TNFalfa,     IL6, aminotransferases, insulin resistance and steatosis verified by ultrasound. Neverthless,     this is the first study that evaluate liver histology after six months of PUFA (omega3) in     the treatment of patients with NASH.   "
98812|NCT01992796|"     The investigators propose a clinical study of irbersartan for the early treatment of severe     sepsis patients with elevated predicted risk of death between. This study will evaluate     whether early administration of the the angiotensin receptor blocker irbersartan provides     significant reduction of 28 days mortality and multi organ failure incidence to patients with     severe sepsis.   "
98813|NCT01992783|"     The aim of this study is to evaluate whether supplementation with resistant starch improves     biomarkers associated with antioxidant status and insulin resistance in subjects with     overweight and obesity.   "
98814|NCT01992770|"     Background:      This study is based on an innovative stepped-care protocol for the management of     musculoskeletal pain in primary care, which is evaluated in a RCT. The intervention have two     core features: it is theory-driven and include systematic tailoring of treatment content. The     tailoring is based on a combination of empirically supported behavioural and medical     determinants of pain-related disability and patients' individual perceptions on personal     goals, facilitators and barriers for health behavior change. In this application, the     intervention is labelled tailored behavioural medicine intervention (TBM).      Objectives:      The aim is to compare effects and cost-effectiveness of a stepped care model including advice     and tailored behavioral medicine pain treatment (experimental condition) with a stepped care     model including advice and physical exercises (comparison condition) for patients with low     back and neck pain and/or widespread pain including fibromyalgia in primary care. A further     aim is to characterize patients who benefit/do not benefit from the respective steps i.e.     treatments varying in dose and content.      Methods:      A stratified randomized stepped care design is applied. Stratification is based on primary     care center and patient risk profile. A consecutive selection is performed at primary care     centers in southern, central and northern Sweden. According to power analysis, 364     participants should be recruited to allow for sub-group analyses. After having received a     minimal intervention (step 1) comprising 'stay-active advice', participants scoring >90 on     the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) are randomly allocated to an eight-week     treatment in step 2. The experimental condition includes supervised physical exercises     integrated with either (a) graded activity, or (b) hierarchical graded exposure depending on     risk profile, i.e. absence or presence of pain catastrophizing and fear-avoidance beliefs.     The comparison condition includes supervised physical exercises irrespective of risk profile.     Primary outcome is pain-related disability complemented with a comprehensive set of secondary     outcomes adhering to the IMMPACT recommendations. Assessments will be made by personnel     blinded for treatment condition at baseline, after step 1 and 2 respectively, and at 12- and     24-month follow-ups.   "
98815|NCT01992757|"     This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF)     levels on cardiopulmary bypass during cardiac surgery can provide information on coagulation     status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements   "
98816|NCT01992744|"     The purpose of this study is to evaluate the correlation between varying levels of     neuropeptides and birth outcomes. Neuropeptides are substances (proteins) produced in the     body in very small amounts but without which the nervous system cannot function properly, and     which might have a role in the health of a newborn. As part of this study, we are collecting     blood samples from pregnant women.      Neuropeptides and hormones can be measured in blood. This study will involve three blood     draws from the participants arm. Demographic information will also be requested, and     participants will be asked to complete questionnaires about their mood and personal     experiences at each visit.      Our hypothesis is that participants with lower levels of brain-derived neurotrophic factor     (BDNF) will be at increased risk for poor birth outcomes.   "
98817|NCT01992731|"     Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged     38-42 years.   "
98818|NCT01992718|"     To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to     benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by     evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging),     ultrasound and ultrasound with elastography).   "
98819|NCT01992705|"     Primary Objective: To determine the rate of downstaging to resectability in patients with     borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative     therapy.      Secondary Objective(s):        1. To assess the disease-free-survival, overall survival, time to recurrence and site of          recurrence in patients with borderline resectable pancreatic cancer receiving          preoperative FOLFIRINOX followed by SBRT        2. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with          resectable pancreatic cancer        3. To determine the radiologic and pathological response associated with preoperative SBRT          and FOLFIRINOX therapy        4. To assess quality of life through and after treatment using the FACT-Hep questionnaire   "
98820|NCT01992692|"     Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of about     3% in patients older than 65 years. Anesthesia in PD patients has been focused by several     studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian     medication or Parkinsonian symptoms. However, our previous experience showed that the     patients undergoing pulse generator placement were more prone to be involved in delayed     emergence in the recovery room, which had been not reported yet. We speculated that PD     patients might be a special population with abnormal pharmacodynamic characters of     anesthetics, though no related evidence could be found to support this hypothesis. Therefore,     in this project we investigated whether remifentanl requirement to inhibit patients' response     to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator     placement was different from non-PD patients undergoing intracranial surgery for reasons     other than PD.   "
99261|NCT01986868|"     This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can     identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other     substances found in the blood) seen on coronary computed tomography angiography(CCTA) and     evaluate whether there is a relationship between the adverse plaque characteristics and the     presence of coronary artery wall inflammation.   "
98821|NCT01992679|"     There is growing evidence that exercise-based rehabilitation results in improvements in     mobility and participation in persons with multiple sclerosis (MS). However, the vast     majority of the scientific evidence in support of this view is based on persons with MS who     have minimal mobility impairment. This is partially due to the lack of accessible exercise     equipment and facilities available to persons with severe mobility limitations.      One option available to persons with severe mobility limitations is body weight supported     treadmill training. Indeed, this rehabilitation approach has been utilized with some success     in various clinical populations, such as stroke and spinal cord injury, and is believed to     target neuroplasticity. Specific to persons with MS, body weight supported treadmill training     has shown great promise in improving quality of life, symptoms and functional mobility in two     small (n=4 and n=6) pilot investigations. However, previous research has been hampered by     methodological limitations including small sample size, lack of a control group and limited     training sessions. Consequently, no firm conclusion regarding the benefit of body weighted     supported treadmill training in persons with MS can be drawn. The proposed project seeks to     determine if twenty-weeks of body weight supported treadmill training leads to improvements     in physiological function, mobility and quality of life in persons with MS with severe     mobility limitations. The outcomes of this project have the potential to lead to new     rehabilitation approaches capable of improving function and quality of life in persons with     advanced MS.   "
98822|NCT01992666|"     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology     includes genet-ic and environmental factors. It is rare in children as compared to adults.     The severity may be related to greater involvement of genetic factors in children. The impact     of genetics in the development of SLE is important, and the risk of recurrence in siblings     evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8 rheumatoid     arthritis, thereby indicating high impact of genetics in SLE.      Recently, the group of Professor Yanick Crow in Manchester and other teams has identified new     forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite     lupus.      Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene,     which therefore represents the first genetic cause of SLE. The team of Professor Crow also     identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal     enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in     two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of     SLE. These new genes SLE were identified through research of germ-line mutations in cases of     lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing     characterization of a novel gene of SLE in a family and we have identified a second locus     identified in another family. The identification of these genes provides a better     understanding of the mechanisms regulating immune tolerance in humans. The frequency of these     genetic forms is not known. There is very little data on the immunological phenotype of these     patients.      This is a clinical study to investigate the genetic and immunological abnormalities     associated with pediatric SLE. The aim are to:        -  study the genetics of pediatric SLE (or syndromic or family) and to search for mutations          in the known genetic lupus or new genes in collaboration with Professor Yanick Crow.        -  study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE          (or syndromic or family) in the large Rhône- Alpes- Auvergne area.   "
98823|NCT01992653|"     This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability,     pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with     rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy)     in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses     of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of     rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP).     Participants will be treated for a total of six or eight cycles in accordance with local     institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin     in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2     dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is     combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at     MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.   "
98824|NCT01992640|"     During laparoscopic surgery, muscle relaxants are often administrated in order to ensure     acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.      The degree of muscle relaxation is monitored by use of an acceleromyography and at the end of     surgery another drug - Neostigmine- is given to reverse the muscle relaxation. However,there     may still be a blockade of up to 70% of the receptors.      This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged     hospitalization.      This study will describe changes in balance and subjective muscle weakness after laparoscopic     surgery.      The primary hypothesis is that sway area is increased 30 min after extubation compared to the     preoperative value.   "
98825|NCT01992627|"     This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the     treatment of elbow epicondylosis   "
98826|NCT01992614|"     PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary     purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and     pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.   "
98827|NCT01992601|"     This clinical trial is designed to compare the pharmacokinetic characteristics of combination     and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also     investigate drug interaction between separate and combination administration.      Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day     administration, 16 days washout after 6th day of administration.      The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over     design during 2 each period.      The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a     cross-over design during 2 each period.   "
98828|NCT01992588|"     This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the     investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin     aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin     infusion (CSII).   "
98913|NCT01991457|"     The goal of this research is to test if the conditioning regimen, fludarabine and total body     irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment     regimen for ALL patients older than 40 years of age and/or younger patients with high risk     medical conditions. The primary objective is to establish the efficacy of allo HCT in older     ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also     assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative     FluTBI conditioning regimen.   "
99301|NCT01986348|"     This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral     Selinexor in patients with recurrent gliomas.   "
98829|NCT01992575|"     Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of     these conditions, retinal vein occlusions are the most common. Vision loss can occur as a     result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid     build-up at the macula).      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal     and choroidal tissue structures in real time. It is similar to ultrasound imaging, except     that OCT measures the intensity of reflected light rather than sound waves.      The purpose of this study is to see if non-invasive OCT technology can changes due to retinal     vein occlusions as well as the more invasive fluorescein angiography, which requires an     injection of dye into the vein of an arm of a patient. The study will also compare the     mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein     angiography and OCT. These studies will be evaluated to see how they relate to vision loss.   "
98830|NCT01992562|"     This is a phase 4 study being conducted at the Ohio State University Department of Neurology     Multiple Sclerosis Research Program. The purposes of the study is to administer a single shot     of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or     spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain     from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has     not responded to other pain medicines. Study Hypothesis: We intend to determine if a single     shot trial (SST) of intrathecal (IT) ziconotide will temporarily reduce pain in these     patients. In the proposed study, patients will receive two injections, one of which is the     ziconotide and one which is a placebo. They will be blinded and not know which order they     receive the treatment versus placebo. The results of this clinical trial will provide a     focused examination of ziconotide efficacy and safety in patients with painful neuropathies     or myelopathies that have not been effectively treated with other pain medications. Moreover,     the use of a single shot trial (SST) IT injection in the outpatient setting will provide     evidence for application of this technique in outpatient neurological clinical practice,     thereby improving access to this specific patient population. Ziconotide is currently FDA     approved for this indication and route of administration. Therefore, a study design that     improves the feasibility of ziconotide trialing specifically in the neurology clinic (that     is, single shot administration) is being used in order to ensure its broader use by     neurologists who routinely care for neuropathy and myelopathy patients. Information from this     study will also inform future studies of predictors for long term efficacy after pump     placement.   "
98831|NCT01992549|"     The purpose of the study is to collect long-term data on the inhibitor development rate of     Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.   "
98832|NCT01992536|"     The purpose of this extension study is to evaluate the immunogenicity and safety of a booster     dose of a MenABCWY vaccine, administered 24 months after completion of the primary     vaccination series, in subjects who previously received the same vaccine formulation in study     V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the     primary vaccination and 12 months after the booster dose will also be evaluated in these     subjects.      In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations     (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously     received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV).     These subjects will be followed for safety and immunogenicity for 12 months after vaccination     in study V102_03E1.   "
98833|NCT01992523|"     The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the     superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill     both orally administrated in decreasing residual platelet reactivity 1 hour after the     administration among 70 patients with STEMI (ST segment elevation myocardial infarction)     undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.   "
98834|NCT01992510|"     The study was conducted to investigate how postural changes including sitting, supine, and     LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone     oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes     and the fellow eyes in each body position.   "
98835|NCT01992497|"     Effect, tolerance and safety of a supplementation with a probiotic on the risk of     gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants     born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the     formula-fed and in the breastfed feeding groups.   "
98836|NCT01992484|"     The aims of the study are to:        -  explore whether platelet reactivity in patients treated wih novel platelet inhibitors is          associated with clinical outcome        -  investigate whether a therapeutic window exist for novel platelet inhibitors        -  investigate the incidence of adverse events under treatment with novel platelet          inhibitors in the real life clinical scenario        -  investigate the association between genetic polymorphisms, inflammation, platelet          reactivity and clinical outcome        -  investigate synergistic effects between aspirin and novel platelet inhibitors   "
98837|NCT01992471|"     The purpose of this study is to find out what kinds of information people would like to     receive from a new kind of genetic testing, and how they respond to this new kind of testing.   "
98840|NCT01992432|"     This study will use advanced MRI techniques to characterize the changes that occur to the     structure and functionality of the brain in older breast cancer patients receiving adjuvant     chemotherapy, and determine the relationship between the brain changes and severity of     chemotherapy toxicity. Our results will be an early step towards identifying neuroimaging     markers of aging, breast cancer and chemotherapy treatment, and will contribute to our     understanding of the underlying pathophysiology of cognitive changes and chemotherapy     toxicity in vulnerable, older adults with cancer. Furthermore, the work will lay the     foundation for future, larger scale clinical studies of cognitive changes and chemotherapy     toxicity in the aging cancer population.   "
98841|NCT01992419|"     The purpose of this study is to measure an improvement in the detection rate of cardiac     arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for     non-medical operators who receive emergency calls.   "
99302|NCT01986335|"     The objectives of this study were to analyze the immunogenicity and reactogenicity of     DTP/HB/Hib (Bio Farma) combination vaccine.   "
98842|NCT01992406|"     Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access     routes give the opportunity to reduce surgical access trauma leading to a more painless     surgery and enhancing a fast postoperative recovery. Experience with transvaginal     laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that     such NOTES procedures are feasible and safe. The complication rate to conventional     laparoscopic procedures is similar. Since transvaginal access is impossible in men, an     alternative route is missing. There are experimental studies and small case series reporting     the feasibility of transrectal anterior resection. However any prospective feasibility study     demonstrating the safety of the procedure and functional outcomes (sphincter function) are     missing. This study investigates the feasibility, practicability, safety and subjective as     well as functional outcome of transrectal hybrid-NOTES anterior resection.   "
98843|NCT01992393|"     For this project we propose to refine the psychosocial intervention developed in phase one,     based on input from key stakeholders, and to test the feasibility, acceptability and     preliminary efficacy of the intervention. The proposed project addresses unmet public health     needs for a historically hard-to-reach group of individuals with epilepsy and comorbid     serious mental illnesses, and as the intervention is an adjunct to care that individuals with     serious mental illness are already receiving, and uses staff already likely to be present in     a care system, it is ideally suited for real-world implementation in people with epilepsy     and serious mental illness (E-SMI).      The purpose of this study is to try and engage individuals with E-SMI to actively participate     in illness self-management and treatment adherence that are crucial in minimizing the     morbidity and mortality associated with both chronic mental disorders and chronic     neurological conditions.   "
98844|NCT01992380|"     This study will test if two 18F-AV-1451 PET scans up to 4 weeks apart in healthy volunteers,     MCI and AD subjects provide the same results.   "
98845|NCT01992367|"     This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the     safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of     ASLAN003 in healthy subjects   "
98846|NCT01992354|"     The PET/MR device components and accessories are under development in order to optimize,     validate and improve the design including improving the quality of images. The purpose of     this study is:        -  Aim 1: Perform iterative evaluations of the device (including features and components)          to optimize device performance and assess feasibility of new features;        -  Aim 2: Perform activities in support of design validation as needed for regulatory          submission;        -  Aim 3: Evaluate device complaints and analyze potential causes.   "
98847|NCT01992341|"     The purpose of this study is to evaluate the pharmacokinetics of paclitaxel when given alone     and in combination with AMG 386 to determine whether AMG 386 alters the pharmacokinetics of     paclitaxel   "
98848|NCT01992328|"     Immunoglobulin G deficiency subtypes in patients with asthma six months once a month     intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on     reducing the frequency of asthma exacerbations appreciate.   "
98849|NCT01992315|"     Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose     tissue, continues to be the tissue of choice in repairing soft tissue defects due to     traumatic or other defects. Current autologous fat transfer techniques, however, have a     number of limitations including significant donor site morbidity, unpredictable resorption,     and the potential for requiring revision. Thus, an off-the-shelf material that retains the     mechanical and biological properties of adipose tissue would be ideal for the reconstruction.      Extracellular matrix (ECM)-based biomaterials have the potential to be a non-immunogenic     biological scaffold for adipose tissue engineering for repair of soft tissue defects. Our     collaborators have recently generated a novel tissue-derived material to improve soft tissue     reconstruction. The final, processed adipose tissue does not contain cellular components, yet     retains the native architecture and bioactivity of the original adipose tissue. The tissue is     then further processed into particles to create an injectable implant. In preclinical models,     we have demonstrated that human adipose tissue can be decellularized by mechanical processing     with preservation of matrix ultrastructure. Histologic analysis two-weeks after implantation     into rats showed minimal inflammatory reaction and good tissue integration of the     decellularized, dilipidized, adipose derived-ECM.      The goal of the study is to 1) evaluate the safety and compatibility of the soft tissue     implant, and 2) determine the efficacy of this ECM replacement in soft tissue injuries after     6 weeks. Specifically, the volume of the soft tissue defect will be determined before     implantation and at multiple time points over the following 6 weeks. We hypothesize that the     decellularized adipose ECM will retain at least 50% volume and surface area after 6 weeks. If     our results are promising, decellularized adipose derived-ECM may be a viable alternative to     autologous tissue transplantation for correction of soft tissue deformity.   "
98850|NCT01992302|"     In this study we tried to elucidate the factors associated with the development of a rapid     cycling course in bipolar disorder patients, in a prospective and longitudinal design, and     the role of antidepressants. The identification of risk factors is extremely relevant from     the clinical point of view. We hypothesized that rapid cycling bipolar disorder is associated     with more chronicity, poor outcome, and more antidepressant prescription.   "
98851|NCT01992289|"     The goal of the ECP-002e extension study is to continue the evaluation of all EDI200-treated     ECP-002 subjects up to age 10 yrs. No additional study drug administration is planned. The     efficacy evaluations will incorporate growth and development parameters, frequency of     infections and hospitalizations, and age-appropriate assessments of ectoderm-derived organ     function. The safety evaluations will include physical examinations, adverse events and     concomitant medication documentation, and laboratory testing. Funding Source - FDA OOPD   "
98852|NCT01992276|"     The purpose of this study is to evaluate the rate of decline in quantitative viral load     measured in hospitalized patients with Influenza A infection   "
98853|NCT01992263|"     The goal of this study is to understand the effects of vitamin D supplementation on     immunological outcomes among patients with tuberculosis.   "
98854|NCT01992250|"     This study examines the use of cryoablation as an alternative to surgery in the treatment of     early stage invasive breast cancer. The hypothesis is that cryoablation will complete     ablation and destroy the tumor in a selected population of women who may otherwise be     adequately treated with surgery.   "
98914|NCT01991444|"     Registry study to evaluate the predictive value of a comprehensive geriatric assessment with     regard to the outcome of a transcatheter aortic valve Implantation.      It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best     suited to predict the therapeutic success of a heart valve Implantation in elderly ( > 80     years) Patient. Possible participants are all Patient of 80 years or above for whom the     implantation of a Edwards Sapien XT aortic valve is planned   "
98855|NCT01992237|"     With the perception that lung protective ventilation with regard to low tidal volume     ventilation and limiting airway pressures improves outcome in ARDS (acute respiratory     distress syndrome) and that the development of new technical devices of extracorporeal lung     assist systems with lower complication rates support establishment of lung protective     ventilation strategies these systems are more and more frequently used. All critically ill     patients with and without ECLA (extracorporeal lung assist)/ECMO (extracorporeal membrane     oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and     higher mortality risk. Besides inflammation malnutrition is known as one of the main risk     factors. Over and underfeeding should be prevented. However nutritional aspects of patients     on extracorporeal lung assist are hardly investigated. Up to now changes in metabolic rates     induced by ECLA/ECMO are poorly described. Factors like work of breathing, changes in cardiac     output and septic state are influencing energy metabolism but until now there is no tool for     measuring energy expenditure in clinical routine for patients on ECLA/ECMO. Indirect     calorimetry is a simple device only for patients without ECLA/ECMO system. Oxygenation and     CO2 (carbon dioxide) elimination by the lung assist system can be calculated but is not     implemented to clinical routine. The combination of indirect calorimetry and calculation of     lung assist function at the same time would give us the chance to adapt nutrition rates to     energy expenditure. This may prevent muscle wasting and weakness. This pilot study will     include 40 participating patients during 8 month investigating nutritional therapy adapted to     energy expenditure calculated by O2 and CO2 turnover rates in patients on ECLA or ECMO     systems. The investigators aim is to describe a calculation to set nutrition targets in ECMO     patients. Second the investigators will describe level of nutritional needs under     consideration of different mechanical ventilation states. Third O2 consumption and CO2     elimination will be used to estimate cardiac output.   "
98856|NCT01992224|"     Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most     common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and     intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And     mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to     initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and     conventional MV, and we hypothesize that early MV may be a better treatment option.   "
98857|NCT01992211|"     The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability     of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to     evaluate the food effect of Pharmacokinetic profile of BCWP_C003 after administration.   "
98858|NCT01992198|"     Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate     (meropenem) therapy,which one is better.   "
98859|NCT01992185|"     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the     safety and efficacy of Photocil in the treatment of vitiligo.   "
98860|NCT01992172|"     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the     safety and efficacy of Photocil in the treatment of atopic dermatitis.   "
98861|NCT01992159|"     The purpose of this study is to determine if treatment with romosozumab increases bone     mineral density in Japanese women with postmenopausal osteoporosis.   "
98862|NCT01992146|"     Recent studies have focused on the role of endogenous opioids on central sensitization.     Central sensitization is known to be impaired or altered in chronic pain conditions, as     fibromyalgia or chronic tension headache.      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone     administration after resolution of an injury. This suggests latent sensitization.      In the present study, investigators hypothesize that a high-dose target-controlled naloxone     infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a     unilateral primary open groin hernia repair procedure. Investigators aim to show that latent     sensitization is present in humans and is modulated by endogenous opioids.   "
98863|NCT01992133|"     Gestational Diabetes Mellitus (GDM) and vitamin D deficiency are related to insulin     resistance and impaired beta-cell function, with heightened risk for future development of     diabetes. The investigators hypothesize that vitamin D supplementation to women with previous     gestational diabetes may improve glucose metabolism.   "
98864|NCT01992120|"     The primary objective of the proposed study will be to determine if a multi-modality teaching     curriculum utilizing high-fidelity simulation and didactic lecture will result in sustained     improvement by internal medicine residents in written knowledge and clinical performance when     compared to residents receiving a curriculum utilizing only didactic lecture. The     investigators hypothesis is that the addition of high-fidelity simulation to a traditional     didactic lecture curriculum will result in sustained and superior written knowledge and     practical performance when compared to a group receiving only didactic lecture on the same     topic. Specifically, the investigators will be assessing internal medicine resident knowledge     and performance in the area of sepsis in the hospitalized patient, and will shape the     investigators teaching curriculum around this focus.   "
98865|NCT01992107|"     Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than     4 years old to less than 18 years old.   "
98866|NCT01992094|"     Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and     above.   "
98867|NCT01992081|"     This study will test two instruments to measure physical activity in COPD patients: A     questionnaire and two small physical activity monitors .Patients will be randomized to either     receive the telecoaching program in addition to usual care or only the usual care. Study will     include around 510 patients in 5 countries in Europe.   "
98868|NCT01992068|"     The purpose of this study is to prospectively assess the feasibility of high-resolution     manometry to identify radiation-induced changes in esophageal motility and contractility or     function in patients undergoing radiation therapy for the treatment of locally advanced     lung cancer.   "
98934|NCT01991184|"     This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics     of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's     lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed     in subsets of patients.   "
98915|NCT01991431|"     This is an international multi-center, prospective, observational registry with consecutive     patient enrollment intended to determine outcome Parameters within 30 days after transaortic     transcatheter aortic valve replacement.   "
98869|NCT01992055|"     This Clinical Trial is a pilot study being conducted to study the impact of a specific     cognitive rehabilitation program, Goal Management Training (GMT), in adult patients with     executive dysfunction and associated problems in everyday functioning. The intervention     program will also include relaxation training and psychoeducation regarding brain injury on     everyday functioning, emotional status, and executive functioning. Goal Management Training     focuses on teaching individuals strategies to compensate for executive functioning deficits     and is based on a theory of goal neglect resulting in disorganized behavior following frontal     lobe injury. It emphasizes strategies for self-monitoring and self-evaluation in everyday     life. Given its goal-oriented emphasis, focus on individual everyday difficulties, and     reports of improvements in self-reported executive failures and mood, GMT appears to be an     ideal intervention treatment for individuals with executive and functional deficits.      Given the emphasis of goal-oriented rehabilitation on reducing the impact of cognitive     impairment on daily functioning, rather than attempting to restore cognitive abilities, a     reduction in subjective reports of psychological distress is anticipated. This hypothesis is     consistent with existing literature revealing reduced reports of annoyance and executive     difficulties on self-report inventories. Improvements on tests of sustained attention and     visuospatial problem-solving, as well as small effects on additional measures of planning,     are also anticipated.   "
98870|NCT01992042|"     This research study provides a novel opportunity to examine the intra-prostatic tumour     inhibitory effects of statins in men with prostate cancer undergoing surgery.   "
98871|NCT01992029|"     The principal goal is to demonstrate that a specific pattern of microRNA (miRNA) expression     can be correlated with the definite diagnostic of Amyotrophic Lateral Sclerosis (ALS). The     investigators will use biological sample (from muscle biopsy, Cerebrospinal Fluid (CSF) and     blood sample) collected in three control populations: definite ALS patients according to El     Escorial diagnostic criterion, control patients without any neurological disease having an     orthopedic surgery for shoulder disease, and control patient explored for peripheral     neuropathy and myopathy. A second goal will correlate the miRNA pattern to the severity     and/or progression rate of the motor neurons define as the progression rate of the     Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score/year.   "
98872|NCT01992016|"     This pilot clinical trial studies fludeoxyglucose F18 (FDG)-positron emission tomography     (PET) in imaging patients with prostate cancer treated with ranolazine. Diagnostic     procedures, such as FDG-PET, may help find prostate cancer and find out how far the disease     has spread. Giving ranolazine may enhance FDG-PET imaging by increasing the amount of glucose     available for uptake by the scan.   "
98873|NCT01992003|"     The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb     Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level     analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood     hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.   "
98874|NCT01991990|"     This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics     effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and     survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV)     RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil     kinetics data will be collected for all subjects up to Day 10 of the study. Following the     last study visit on Day 10, all subjects will attend two further safety follow-up visits on     Day 28 and Day 56.   "
98875|NCT01991977|"     This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission     tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing     radiation therapy. Comparing results of diagnostic procedures done before and during     radiation therapy may help doctors predict a patient's response to treatment and help plan     the best treatment.   "
98876|NCT01991964|"     The hypothesis of the study is that laryngeal US can accurately and reliably diagnose     laryngomalacia in infants with congenital stridor.      Stridor is a respiratory noise caused by partial obstruction of the large airways at the     level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor     is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold     standard. However, FLB under sedation has some drawbacks as it requires venous access, use of     sedative agents, may cause discomfort for the patient and is costly.      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique.     It allows for dynamic assessment of moving structures in an awake patient and the results can     be easily displayed and recorded.   "
98877|NCT01991951|"     We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no difference     in thromboembolic or bleeding events between patients with short term warfarin therapy (2     weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after     procedure).   "
98878|NCT01991938|"     This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR     kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This     clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2     (Expansion). The purpose of this study is to evaluate the safety (including the recommended     Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the     anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how     subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor     biopsies (in consenting subjects), and blood samples.   "
98879|NCT01991925|"     Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality     of life and the delivered quality of care in the hospital.   "
98880|NCT01991912|"     The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity     .This is further magnified by the disease being more common in elderly with associated     medical comorbidities and being usually global involving multiple levels.The purpose of this     study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic     Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.   "
98935|NCT01991171|"     Forty-eight female patients will be randomized into three groups to receive the Kinesio     taping, placebo Kinesio taping and control group. The group Kinesio taping receive the     correct application of the method described. The placebo group will receive a placement     without tension. The control group did not receive any form of intervention.   "
98881|NCT01991899|"     It is a clinicaltrial Phase III , randomized, double -blind , 4-arm (390 each one):      This study will include 1560 children and will use 3 batches of vaccine produced by Bio -     Manguinhos with viral bulk of GSK combined measles , mumps and rubella applied in healthy     children 12-15 months of age, and 01 batch of MMR to reference( GSK ), applied in healthy     children aged 12-15 months old . The vaccine is administered as MMR 1st dose.      Two hypotheses are tested :        1. Consistency of production ( equivalence between batches )of 3 batches of vacines(TV1,          TV2 , TV3 Bio- Manguinhos). Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro), ie,          the measles, mumps and rubella in Brazil is as immunogenic and safe as the measles,          mumps and rubella reference, already used in routine NIP (production          Bio-Manguinhos/FIOCRUZ with viral concentrate, bulk, GSK).           The MMR vaccine (Bio-TV) will have the same composition (vaccine strains) and the same          method of production of MMR (TV-GSK): Wistar RA27 / 3 rubella, Schwarz strain of measles          vaccine, and strain RIT 4385 - derived from the Jeryl Lynn strain of mumps vaccine.           As 2nd dose, children receive the vaccine tetraviral measles-mumps-rubella-varicella,          aged 15-18 months, according to the guidance of the National Immunization Program.        2. Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro):the measles, mumps and rubella          vaccine in Brazil is as immunogenic and safe as the measles, mumps and rubella          reference, already used in routine NIP (production Bio-Manguinhos/FIOCRUZ with viral          concentrate, bulk, GSK).      Returns for blood sampling will be scheduled for 51 days, ranging from 42 to 60 days after     dose of MMR vaccine dose and after tetraviral. We will colect the firt blood sample before     the first vaccination too.      It will describe the major adverse events observed after vaccination , comparing their     frequency in groups of MMR vaccine with the Brazilian reference vaccine .   "
98882|NCT01991886|"     Recent large studies have shown that not all premature babies need to be intubated (have a     breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant     routinely. Those studies showed that even very small babies can be safely supported using     nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using     nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to     breath, albeit with additional support to reduce their work of breathing. However nCPAP has     some drawbacks, including that it can cause skin damage to the nose, and that the heating and     humidification of the gas is not always sufficient. We have been using, for over 5 years, a     different system to support babies after routine intubation. This is another type of     noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision     Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV     and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior     to nCPAP in respect it does not cause nose damage and its heating and humidification is     excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard     commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born     less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation.     This study is important to establish the feasibility of using nHF immediately after birth.   "
98883|NCT01991873|"     This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate     the progression-free survival during maintenance therapy.      Eligible patients will be treated within a 12-week induction therapy. Those patients     achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction     treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive     chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of     progression, re-induction treatment will be started.   "
98884|NCT01991860|"     A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at     moderate-to-high risk of PONV.   "
98885|NCT01991847|"     The purpose of this study is to determine the feasibility of a one year exercise training     program in post-surgical patients with colon cancer.   "
98886|NCT01991834|"     Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents     numerous advantages over laparotomy, among them lower rates of surgical site infection and     less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted     and performed by most gynecologists. However, there isn't literature evidence to support the     routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic     surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis     in gynecological laparoscopies not including opening hollow viscera.   "
98887|NCT01991821|"     A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at     moderate-to-high risk of PONV.   "
98888|NCT01991808|"     This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and     after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial     cancer.   "
98889|NCT01991795|"     The purpose of this study is to compare the effect of ticagrelor versus placebo in patients     with Type 2 Diabetes Mellitus.   "
98890|NCT01991782|"     The purpose of this study is to determine whether telemedicine video calls for follow-up     visits between patients and their orthopaedic trauma surgeons has an impact on patient     satisfaction, quality of life, and treatment adherence. This study will also assess the     feasibility of telemedicine as a medium for follow-up visits.   "
98891|NCT01991769|"     The purpose of this study is to examine whether exercise reduces the postprandial effects of     an unhealthy meal on heart function and endothelial function.      Both healthy people and type 2 diabetes subjects will during three days either carry out two     different sessions of exercise training or not before ingesting an unhealthy meal high in     saturated fat and fast carbohydrates. The two different exercise training modes used are high     intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise     training in advance of an unhealthy meal will improve endothelial- and cardiac function in     healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects     on the endothelium more than MIT.   "
98892|NCT01991756|"     The primary objective of the study is to evaluate the acute safety of deploying and     implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for     endovascular repair.      Secondary objectives are to evaluate the acute and longer-term safety and performance of the     Altura Endograft through 5 years.   "
98893|NCT01991743|"     We plan to conduct a prospective, single blinded, randomized clinical trial to assess the     impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction     during, external version for breech fetal position and the incidence of vaginal vs. Cesarean     delivery.      The research aim of this project is to determine the ideal neuraxial dosing strategy to     maximize success of external cephalic version (ECV).      The research questions, does a combined spinal-epidural (CSE) of a higher dose result in     greater success in converting a breech presentation to vertex during external cephalic     version (ECV).      The hypotheses of this project is that CSE at higher dose will result in greater ECV success     than analgesic dosing.      The research significance:Increasing the success and comfort of ECV for fetal malpresentation     may help decrease the cesarean section rate.   "
98894|NCT01991717|"     Cataract surgery is among the world's most frequently performed operations. It involves     removal of an opaque lens from the human eye and implantation of an artificial lens. The     operation is performed under local anaesthesia using ultrasound technology, by which the lens     is emulsified and removed by suction.      Femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can     improve the quality of cataract surgery and provide a new best possible standard of quality.     In contrast to the conventional method the capsulotomy and the fragemntation are fully     automatically performed with a femtosecond laser. In addition, the lens is fragmented by the     laser, which substantially facilitates its removal and reduces the operation time.      Study to investigate whether the femtosecond laser cataract surgery causes any significant     differences in clinical outcomes as compared to the conventional, manual continuous     curvilinear capsulorhexis (CCC).      Effective phako time (EPT) is defined as duration of phakoemulsifikation of the crystalline     lens.      EPT of conventional surgery at intraoperative visit > EPT oflaser-assisted surgery at     intraoperative visit   "
98895|NCT01991704|"     In order to determine whether the 'incubation of craving' phenomenon also occurred in     alcoholics, investigators employed an experimental approach to investigate the time course of     cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four     groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced     alcohol craving . Another group including 19 patients was repeatedly tested for the     cue-induced alcohol craving at the above abstinence days. Other psychological and     physiological measures were administered at the four abstinence time points.   "
98896|NCT01991691|"     This study is a single arm feasibility study. Patients that have been diagnosed with     carcinoma and are undergoing chemotherapy have to document chemotherapy associated side     effects on a regular basis by means of a tablet-based online questionnaire. Goal of the study     is to find out if patients that are undergoing chemotherapy are willing to document     chemotherapy associated side effects by means of a tablet-based online questionnaire.   "
98897|NCT01991678|"     The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with     mild, moderate, or severe hepatic impairment.   "
98898|NCT01991665|"     A failed operative vaginal delivery is associated with increased risk of maternal and     perinatal complications. It is very important the determination of the fetal head position     prior to instrumental delivery.      Generally,diagnosis of the fetal head position is made on transvaginal digital examination by     delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of     studies on the accuracy of digital examination but the general consensus is that     reproducibility is low and diagnostic uncertainty remains high even for operators with much     experience.      As the traditional clinical evaluation has many limitations, a new tool capable of increasing     diagnostic objectivity and accuracy would be of great interest.      The aim of our study was to evaluate, in a prospective study, if the complementary use of     ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play     a role in labor outcome.   "
98899|NCT01991652|"     Significant progress has been made in the treatment of Wilms tumor in high income countries,     where survival is now around 85% - 90%. Survival in low income countries is much lower;     specific challenges include late presentation, malnutrition, less intense supportive care     facilities and failure to complete treatment.      A comprehensive treatment guideline was introduced in Malawi in 2006 which included     nutritional support and social support to enable parents to complete treatment. Survival has     increased to around 50%; 95% of children completed their treatment. A multi-disciplinary     group of African clinicians and 'state of the art' experts produced a consensus treatment     guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be     implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes,     expecting about 200 new patients per year.      The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete     treatment and <10% treatment related mortality. Other research questions include efficacy and     toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology     and central review pathology in stratifying postoperative chemotherapy.   "
98900|NCT01991639|"     Background: In elderly subjects frailty and malnutrition are very common and can lead to     serious health hazards, increase mortality, morbidity, dependency, institutionalization and a     reduced quality of life. In Austria, the prevalence of frailty and malnutrition are     increasing steadily and are becoming a challenge for our social system. Physical training and     adequate nutrition can invert it.      Methods/Design: In this randomized, controlled trial 80 malnourished, frail,     community-dwelling patients (≥ 65 years) are recruited. Additionally, 80 lay volunteers (≥ 50     years) named buddies are recruited and subsequently trained regarding health enhancing     physical activity and nutrition in three standardized training sessions. These buddies visit     the malnourished, frail subjects at home twice a week for about one hour during an initial     period of 10-12 weeks. While participants allocated to the intervention group (n=40) conduct     intervention to improve their fluid intake, their protein and energy intake, perform strength     training and try to increase their baseline activities, the control group (n=40) only gets     home visits without any special intervention. After 10-12 weeks, both, the intervention and     the control group, receive the nutrition intervention and the physical training. Health,     nutrition and frailty status, physical fitness and body composition and chronic inflammation     of buddies and frails are recorded before the intervention, after 10-12 weeks, and after 6     and 12 months.      Discussion: To the investigators knowledge this trial is the first of its kind to provide     nutrition and physical activity intervention to malnourished, frail, community-dwelling     subjects by trained lay buddies, in which the health status of buddies is also expected to     improve. This study assesses the effectiveness of such an intervention. If successful, the     intervention offers new perspectives for the management of frailty and malnutrition.   "
98901|NCT01991626|"     Previous studies on iron absorption have focused on the effects on the addition of iron     absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic     phytic acid removal through phytase. The investigators want here to investigate the effects     of fat on iron absorption with and without the addition of exogenous phytase as a potential     iron absorption enhancer in lipid nutrient supplements (LNS) products compared to     micronutrient powder(MNP) products.      Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to     induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric     density of a meal by increasing its fat content might enhance iron absorption by delaying     gastric emptying, gastric acid secretion and increasing Fe stomach residence time.   "
98902|NCT01991613|"     We hypothesize that premature infants who receive their mothers' expressed breast milk     supplemented with liquid protein early in their hospitalization will have a growth velocity     in the first 28 days of life that is 20% greater than the growth velocity of premature     infants that do not receive protein fortification.   "
98903|NCT01991600|"     Iron deficiency is the most common micronutrient deficiency in the world today, affecting     more than 60% of the global population (www.who.int/nut/ida.htm). The two main strategies for     the prevention and treatment of iron deficiency involve fortification of food with iron, or     direct supplementation with iron tablets. Simple iron salts (e.g. ferrous sulphate) are well     absorbed but at supplemental levels (and potentially at lower levels, as used in food     fortificants) can induce free radical activity resulting in gastrointestinal side effects and     systematic oxidative stress. As a result, supplementation has poor compliance and improvement     in iron status is compromised. Ferric salts are less inclined to produce side effects and     although they are relatively well absorbed at fortification levels in food, they are poorly     absorbed at the higher supplemental doses. Because certain components of food, such as     organic acids, can facilitate ferric iron absorption, we now wish to determine whether     dietary organic acids may similarly enable efficient absorption of supplemental ferric iron     while preventing the formation of non-transferrin-bound iron (NTBI) which is a proxy for free     radical activity. Our strategy is to use an iterative process between in vitro and in vivo     experimentation, aimed at identifying the best choice of organic acid and the optimal ratio     of iron:organic acid. The study was a cross-over, single-dose comparison against     standard-of-care therapy (namely ferrous sulphate) in mildly iron deficient anaemic women.     Both the investigational products and the active comparator were administered as a single     dose on 2 different occasions, i.e. the investigational products on the first study visit and     the active comparator 14 days later on the second study visit.   "
98904|NCT01991587|"     A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging,     placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single     intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine     administered to healthy adults 18-49 years of age.      A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30     subjects to receive one injection of either a low, a medium, or a high dose level of VLP of     the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM)     phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).   "
98905|NCT01991574|"     Ferric hydroxide adipate is a ferric iron supplement containing iron hydroxide and a dietary     organic acid that was developed at MRC Human Nutrition Research. We aim to determine if the     ingestion of ferric hydroxide adipate with food induces a reduction in urinary phosphate     concentration, compared with the administration of placebo plus the same food on a different     occasion. We hypothesise that ferric hydroxide adipate binds some phosphate ions in the     gastrointestinal tract, which prevents part of the phosphate load in a meal from being     absorbed. On another visit, calcium will be given with the same food, as a positive control,     since this element is well known to restrict dietary phosphate absorption through the     formation of insoluble calcium phosphates in the gut lumen. We will compare urinary phosphate     concentrations after co-ingestion of the calcium salt and food versus urinary phosphate     following ferric hydroxide adipate and the same food. Additionally, the calcium data will be     compared with placebo data, since a significant reduction in urinary phosphate concentrations     after calcium treatment will confirm the suitability of the study design.      Finally, iron absorption from the ferric hydroxide adipate treatment will be determined by     labelling this preparation with 58Fe and measuring day 14 erythrocyte 57Fe:58Fe.      The study design is: Three-way cross-over volunteer absorption study. Volunteers will not be     told which treatment they receive (placebo, ferric hydroxide adipate, or supplemental     calcium). Researchers co-ordinating the study on a day to day basis will be aware of     treatment allocation, but analysts will not be told which samples correspond to which     treatments.   "
98906|NCT01991561|"     A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the     Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine     adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in     healthy adults 18-60 years of age.   "
98907|NCT01991548|"     This four center international study will include two United Kingdom National Health Service     centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate     subject acceptance of a new insulin pump and transmitter together with the accompanying     training materials. Descriptive data from participant questionnaires and device uploads will     be evaluated.      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of     age upwards, who currently use an insulin pump in the management of their type 1 or type 2     diabetes, will be invited to participate. Each subject will be trained on the study device     and then use it for approximately four weeks. During this time there will be three in-clinic     visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of     this period, they will revert back to their original insulin pump and complete a     questionnaire on the study pump training materials, features and usability.   "
98908|NCT01991535|"     The purpose of this study is to determine whether breathing pattern (specifically the     inspiratory time/total respiratory cycle value) has an influence over the response to the     noninvasive mechanical ventilation.   "
98909|NCT01991522|"     Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning     colonoscopy typically learn the procedure experientially but simulation based teaching is     increasingly being integrated into training programs. The optimal manner to teach colonoscopy     on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based     colonoscopy with self-directed learning on simulators.   "
98910|NCT01991509|"     The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101     when administered intravenously or subcutaneously to healthy volunteers.   "
98911|NCT01991483|"     This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in     hemodialysis participants. This study will involve multiple doses of LY2928057 given during a     6 week period either after a participant discontinues or reduces treatment to stimulate red     blood cells. This study will last up to 26 weeks for each participant.   "
98912|NCT01991470|"     The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance     in pediatric patients with insulin requiring diabetes at the beginning, middle and end of     sensor wear.   "
98936|NCT01991158|"     The purpose of this study is to evaluate the efficacy and safety of High dose of Methotrexate     combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line     treatment in patients with de novo extranodal NK/T cell lymphoma.   "
98917|NCT01991405|"     Background:      Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe     than normal cognitive changes due to old age, and less severe than dementia. Reduced working     memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have     indicated that WM can be improved trough computer based training.      Objectives:      The objective of the study is to evaluate if working memory training is effective in     improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training     relates to structural changes in the white and gray matter of the brain, assessed by     structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and     progression to dementia will also be investigated.      Patients and Methods:      The proposed study is a blinded, randomized and controlled trail that will include 90 elderly     patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either     training or a placebo version. The intervention is computerized working memory training     performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI     will be performed before, 6 and 12 months after training.      Relevance:      Currently there is no known treatment available for mild memory impairment/MCI, and few     studies on specific cognitive training in MCI-patients have been performed. The proposed     study has received funding from a Norwegian Health Region. If computer based training results     in positive changes to memory functions in MCI patients this may represent a new,     cost-effective treatment. Secondly, evaluation of training induced structural changes to grey     or white matter may improve our understanding of the mechanisms behind effective cognitive     interventions in MCI patients.   "
98918|NCT01991392|"     Nasogastric decompression was routinely used in most major intra-abdominal operations.     Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting,     and gastric distension). Would and respiratory complications, and to reduce the incidence of     anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric     decompression following elective abdominal surgery has been increasingly questioned over the     last several years. Many clinical studies have suggested that this practice does not provide     any benefit but could increase patient discomfort and respiratory complications. Furthermore,     meta-analyses have concluded that routine nasogastric decompression is no longer warranted     after elective abdominal surgery.      Elective abdominal surgery without nasogastric decompression was initially tested and then     widely used on patients with colorectal surgery.However, after upper gastrointestinal     operations such as gastrectomy, nasogastric has been considered necessary to prevent the     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of     colectomy. In spite more and more studies reported of no need of nasogastric tube after     abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of     lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy     include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive     destruction and potential risk of gastric stasis after PD. However, our pilot study of     retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD     at our hospital showed more than 90% of patients had less than 200cc/day NG drainage amount     within postoperative day three. Theoretically, these patients might not need a nasogastric     tube after pancreaticoduodenectomy. Therefore, investigators propose a prospective     multicenter randomized trial to assess the need of a nasogastric tube after PD.   "
98919|NCT01991379|"     The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and imatinib     on the patient and on Gastrointestinal Stromal Tumor (GIST).   "
98920|NCT01991366|"     The aim of this observational study is to evaluate the in hospital and 6 month outcomes of     the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients     undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction     in a large tertiary referral center.      It is hypothesized that Glycoprotein IIb/IIIa inhibitor use during primary Percutaneous     Coronary Intervention for ST-elevation myocardial infarction/ acute myocardial infarction is     superior to unfractionated heparin alone or bivalirudin alone. Additionally, after propensity     matching this superiority remains.   "
98921|NCT01991353|"     This study will compare meniscal healing with or without platelet rich plasma. The     assessments will include validated, disease specific, patient oriented outcome measures, MRI     arthrogram (MRA). Results of this study will help ascertain whether PRP improves meniscal     healing rates.      Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.   "
98922|NCT01991340|"     This observational study will assess the safety of Herceptin (trastuzumab) in patients with     HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed     for up to 4 years.   "
98923|NCT01991327|"     The primary objective of this study is to assess the drug-drug interactions of Androxal with     cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy     male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and     tolerability of Androxal will be determined in healthy male subjects administered Androxal 25     mg daily for 3 days.   "
98937|NCT01991145|"     This randomized controlled study aims to evaluate the efficacy and safety of allogeneic     umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.   "
98924|NCT01991314|"     Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20%     patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized     by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron     into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise     when total body iron levels rise and protect against iron overload; conversely, in iron     deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins     (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD.     Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it     may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality     of life and fatigue scores comparable to those seen in malignancy.      IBD diagnosed in adolescence interferes with growth, education and employment as well as     psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high     prevalence of psychological distress, particular depression. Limited historical, and our own     data suggest that children and adolescents with IBD are more anaemic than adults, and less     often treated with oral iron. What is not clear is whether the apparent under-utilisation of     oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns     about possible side effects including worsening disease activity.      To address these questions, the investigators propose a comparative study of 6 weeks of oral     iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients     will be given oral iron supplementation. Before and after iron therapy, the investigators     shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived     stress, mood and fatigue; iron metabolism, including serum hepcidin.   "
98925|NCT01991301|"     The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a novel     biological agent used in the treatment of multiple myeloma in preventing graft-versus-host     disease, after stem cells transplantation from unrelated donors.   "
98926|NCT01991288|"     We hypothesize that preoperative saphenous nerve block (SNB) in combination with     periarticular local infiltration provides better post operative pain relief (POPR) profile as     compared to local infiltration alone   "
98927|NCT01991275|"     This study will investigate the efficacy and safety of intrathecal morphine for the patients     undergoing robot-assisted prostatectomy   "
98928|NCT01991262|"     Protocol Title: A Nationwide Epidemiological, Non-Interventional Study Evaluating an     Educational Support Program for Improving Treatment Adherence in Patients with Hepatitis B     Viral Infection      Objective(s): The primary objectives of the study are to assess:        -  HBV treatment adherence rate in patients enrolled in the Support Program        -  Adherence rates at 6m, 12m.      The secondary objectives are to assess:        -  Adverse events rate and profile.        -  Actual treatment duration and dose taken vs. prescribed.        -  The impact of SMS reminders.      Study Design: Eligible patients will be randomized into one of four groups: Group 1 shall     receive both a weekly phone call from a supporter and a daily SMS reminder. Group 2 will     receive a weekly phone call only. Group 3 will receive a daily SMS reminder only and group 4     (Control) shall receive no support.      Study Population: Adult newly diagnosed with Hep B patients, eligible to begin treatment with     first line therapy.      Data Collection Methods:        1. Supporter's documentations of patient's self assessment.        2. Drugs dispense data from pharmacies        3. Pills count.   "
98929|NCT01991249|"     Acute leukemias are a heterogeneous group of hematologic malignancies. They result from     clonal expansion of immature cells whose number is greater than 20% in bone marrow. Childhood     acute leukemias are the most common pediatric malignancies. In Europe and the United states,     they represent about 35% of childhood cancers. 80% of them are acute lymphoblastic leukemia     (ALL) and 15-20% of acute myeloid leukemia (AML). Current treatments allow a cure in about     80% of ALL, while this level is only 50% in AML.Acute leukemia diagnosis is based on the     multidisciplinary exploration of leukemia cells by different techniques:        -  Cellular: cytology, immunophenotyping and cytochemistry        -  Cytogenetic: conventional (karyotype) and molecular (FISH) cytogenetic        -  Molecular: RT-PCR and RQ-PCR      Cytogenetic studies are performed at time of acute leukemia diagnosis. Indeed, the WHO 2008     classification of acute leukemia is based largely on the presence of recurrent cytogenetic     and molecular abnormalities. The most frequent chromosomal aberrations have been associated     with specific clinical and biological characteristics and are now used as diagnosis and     prognostic markers. These chromosomal abnormalities affect genes involving in the     leukemogenesis process. These rearrangements are of several types:        -  Fusion genes causing :             -  Repression of transcriptional activity of genes involved in differentiation of               hematopoietic cells (AML1-ETO, PML-RARA…)             -  Deregulation of signal transduction pathway (eg BCR-ABL chimeric protein with               constitutive tyrosine kinase activity)             -  Changing in the state of chromatin condensation resulting changes of transcription               (MLL gene rearrangements in 11q23, MOZ en 8p11…)        -  Deregulation of genes expression: chromosomal rearrangements can sometimes induce          deregulation of adjacent genes to the breakpoint. For example, inv(3)(q21q26) or          t(3;3)(q21;q26) induce over expression of transcriptional factor EVI-1.        -  Loss of function due to deletion of variable size in genomic regions containing genes          with a role in the differentiation, apoptosis, or cell proliferation (eg IKZF1, PAX5…)      In addition to the karyotype, which allows to have a global view of the genome; FISH, a     targeted technique, is used to highlight invisible abnormalities on karyotype (cryptic     abnormalities) or the time of karyotype failure. However, conventional and molecular     cytogenetic techniques do not highlight any abnormalities (eg different partners involved in     the formation of fusion genes in particular for MLL gene rearrangement, mutations) hence our     interest in next generation sequencing.Indeed, the high throughput targeted sequencing     messenger RNAs (RNA-seq) has the avantage of allow identification of different types of     mutations in a single test, with exception of epigenetic mutations. The importance of RNAs     sequencing rather than DNA genomic is the one hand, a very significant decrease in the volume     of sequences to analyze because transcribed mRNA genes represent about 5% of the genome size     and secondly, a better identification of chimeric genes. The RNA-seq has used as a research     tool in hematologic malignancies. The purpose of this project is to use innovative technology     to develop a new diagnostic and prognostic new tool in hematological malignancies. 50 acute     leukemias will be tested and results will be analyzed according to three criteria:        -  Quantity, quality and relevance of information provided for the diagnosis, monitoring          and therapeutic management compared to a conventional strategy        -  Period required to obtain results and methods to decrease the analysis time so that          results can be integrated into therapeutic decisions.        -  Economic evaluation, which will calculate the cost of this diagnosis option and assess          the cost/benefit ratio In future, other innovative approaches will be implemented (study          of imbalances genomic abnormalities by array-CGH, transcriptome analysis with          micro-array, and study of methylome) to identify the molecular signature of each          leukemia and set of informative abnormalities for diagnosis, prognosis and treatment of          disease and monitoring of residual disease.   "
98930|NCT01991236|"     1.0 Title: The Efficiency and Effectiveness of Video-Based Education for Dermatology     Patients Qualifying for Chronic Treatment with Systemic Corticosteroids      2.0 Background: Past studies have shown that the use of educational videos has been effective     in increasing patient education and satisfaction. These studies suggest that such video tools     may enable an office to be significantly more efficient.      3.0 Objective: The Emory University Department of Dermatology has created an educational     video as part of clinical care. The objective for Phase I of the study is to collect     information about dermatology patients' baseline knowledge about corticosteroid and/or     corticosteroid sparing medication treatment using an online (or written copy) questionnaire.     The objective for Phase II of the study is to determine the effect of a video on dermatology     patient knowledge. The objective for Phase III of the study is to determine the office     efficiency of the video in patients requiring long-term oral corticosteroid and/or     corticosteroid sparing medications. Secondary objectives of the study are to determine     patient and physician satisfaction with the video as an educational tool.      4.0 Patient Selection: Phase I and Phase II: Patients who arrive to clinic during a     participating physician's clinic day at the Emory Dermatology Department. Phase III: Patients     who require treatment with long term oral corticosteroids at the Emory University Department     of Dermatology Clinic as determined by their treatment physician.      5.0 Recruitment: All patients arriving to clinic on a study day will be given an     informational opt-out sheet. All patients will be eligible to complete Phase I and Phase II:     (steroid questionnaire only and steroid video or verbal education plus questionnaires). Only     patients who require long term oral corticosteroid treatment will proceed to Phase III: of     the study. Physicians will be recruited from the Emory Dermatology Department.      6.0 Assessment: Patients in Phase I will complete to the pre-education questionnaire online     (or a written copy). Their results will be compared with baseline results from patients in     Phase III: who undergo treatment with steroids. Patients in Phase II or III will be     randomized to two groups. Control patients will receive verbal discussion of corticosteroid     treatment. Phase II control patient education will be using a script developed by study     physicians and delivered by study personnel. Phase III patients who qualify for long term     systemic steroid will have verbal education by their doctor as usual. Video patients will     receive an educational video instead, and will write down any remaining questions after     viewing for their doctor to address as soon as possible. After verbal or video education,     both groups will take a post-education questionnaire and patient satisfaction surveys online.     Phase II is then complete. In Phase III, both groups will follow-up at least 1, 3, and 6     months after beginning treatment. At follow-up, their doctor will ask about current     corticosteroid dose and frequency, willingness to transition to a steroid-sparing method, and     compliance with preventative measures during treatment. Patients will complete the same     post-education questionnaire online again at these visits. Physicians will also complete     satisfaction surveys online at 1, 3, and 6 months from study start, and then every 6 months.      6.1 Sample size: The sample size for Phase I is unlimited until the last Phase II patient     completes enrollment. Emory plans to recruit a total of 80 patients to participate in Phase     II of this study (40 per group).      6.2 Participant time burden: Phase I only: 5-10 minutes Phase II and III: 30-35 minutes     Physicians: 20 minutes   "
98931|NCT01991223|"     To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder     discomfort   "
98932|NCT01991210|"     This randomized, multicenter, open-label study will evaluate the safety and efficacy of     DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal     cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A     2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per     meter-squared (mg/m^2) IV every 4 weeks.   "
98933|NCT01991197|"     The primary purpose of this study is to determine if sitagliptin (Januvia®) improves     psoriasis severity after 16 weeks of treatment in 20 participants with both psoriasis and     type 2 diabetes mellitus. We will compare the change in psoriasis severity in 20 participants     treated with Januvia® to 20 participants treated with 16 weeks of a comparator drug     (gliclazide, Diamicron®). Participants will be recruited from two centres and after a 4 week     washout period will be followed prospectively for 36 weeks. Participants will be stratified     by centre, psoriasis severity and obesity status after which they will be randomly allocated     to Arm A or Arm B. Participants will be treated with either Januvia® and Diamicron® matched     placebo capsules (Arm A), or Diamicron® and Januvia® matched placebo tablets (Arm B) for 16     weeks and then proceed to an open-label phase where all participants will receive Januvia®     for a further 16 weeks.      Both the research participants and the investigators will be unaware of the trial arm to     which the research participant has been allocated (double-blind study). Research participants     will be prohibited from making any changes to the dose of medications used to treat     psoriasis. If a participant's plasma glycated haemoglobin level (HbA1c) (reflects a     participant's glucose control over the previous 3 months) is above 64mmol/mol eight weeks     after commencing one of the study investigational medicinal products (IMPs) insulin therapy     will be used to improve glycaemic control.      Participants will be assessed at 9 study visits over 40 weeks. Participants will complete     questionnaires, have a medical history recorded and physical examination, blood sampling and     skin biopsies taken (in a small number of willing participants at 3 visits).      The following endpoints will be analysed:      Changes in psoriasis severity at 16 and 32 weeks; changes in validated quality of life     scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs,     time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes     in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic     profiles that predicts best response to sitagliptin therapy.      We hypothesize that sitagliptin therapy decreases psoriasis severity.   "
98938|NCT01991132|"     Non-contact meibography is a useful tool in assessing the health of meibomian glands in     patients. Instead of using normal light in contact meibography, non-contact meibography     utilises infra-red (IR) light. IR light is shined on patients' inverted eyelids and a special     camera then allows visualisation of the structure of the meibomian glands, including the     ducts and acini. Currently, images taken via non-contact meibography are manually analysed by     a skilled clinician.      Knowledge of the health of meibomian glands is useful, especially in the diagnosis of     Meibomian Gland Dysfunction (MGD). Studies have shown that MGD is one of the most common     causes of evaporative dry eye.      Mediview 2.0 is a software that has been programmed to semi-automatically classify meibograph     images taken via non-contact meibography. This software is collaboration with Shanghai     MediWorks Precision Instruments Co., Ltd. The algorithm used was developed by a collaboration     between Agency for Science, Technology and Research (A*STAR) and Singapore Eye Research     Institute (SERI).      This current study aims to validate the diagnostic accuracy of Mediview 2.0 in assessing the     health of meibomian glands of patients, against a trained clinician. We aim to recruit 100     participants for this study.      Once this software is found to be valid, a trained technician could be taught how to capture     the images and hence leaving the doctors with more time to focus on clinical assessment and     treatment instead. Therefore, this study has the potential to increase efficiency in the     clinics.   "
98939|NCT01991119|"     the purpose of this study is to compare the ability of propafenone and dronedarone to     maintain sinus rhythm after DC cardioversion   "
99109|NCT01988883|"     A common complaint among patients with Postural Tachycardia Syndrome (POTS) is brain fog or     difficulty concentrating. This problem is poorly understood.      The purpose of this study is to better understand the cognitive dysfunction associated POTS,     and to determine optimal treatment strategies for this condition. In this study, the     investigators will test the hypothesis that acute administration of the psychostimulant drug     modafinil can improve seated measures of cognitive function in patients with POTS.   "
98940|NCT01991106|"     The prevalence of paediatric obesity has increased over the last two decades and with it, an     increased diagnosis of lifestyle-related diseases in children and adolescents. High intensity     interval training has recently been explored as an alternate to traditional aerobic exercise     in adults with chronic disease and has potential to induce rapid reversal of subclinical     disease markers in obese children and adolescents.      High intensity interval training has recently been explored as an alternate to traditional     aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of     subclinical disease markers in obese children and adolescents.      Goal: The primary aim of this randomised controlled trial is to evaluate the effectiveness of     a high intensity interval training intervention on myocardial function, vascular function and     visceral adipose tissue in obese children and adolescents at baseline, three and twelve     months.      Method: Multi-centre randomised controlled trial of 100 obese children and adolescents in the     cities of Trondheim (Norway) and Brisbane (Australia). Participants will be randomised to (1)     high intensity interval training, (2) moderate intensity continuous training or (3) nutrition     advise. Participants will partake in supervised exercise training and/or nutrition     consultations for 3 months. Measurements for all study endpoints will occur at baseline, 3     months (post intervention) and 12 months (follow up).      Scientific Significance : This randomised controlled trial will general substantial     information regarding the effects of exercise intensity on paediatric obesity, specifically     the cardio-metabolic health of this at-risk population. It is expected that communication of     results will allow for more robust and realistic guidelines regarding exercise prescription     in this population to be formed while outlining the benefits of high intensity interval     training on subclinical markers of disease.   "
98941|NCT01991093|"     Antiplatelet therapy with aspirin-clopidogrel reduces the risk of cardiovascular episodes     after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes.     However, a significant number of patients experience recurrent events while on such therapy.     The individual response to dual antiplatelet therapy is not uniform, and consistent findings     across multiple investigations support the association between a lower degree of platelet     inhibition, high on-treatment platelet reactivity, and the occurrence of atherothrombotic     events [1, 2]. Particularly in diabetic patients, clopidogrel resistance is more prevalent     compared with non-diabetics [3,4], which seems to contribute to the increased     atherothrombotic risk in these patients compared with those without diabetes mellitus (DM)     [5]. A number of platelet function instruments have now become available that are simple to     use and can be utilized as point-of-care (POC) instruments in order to monitor antiplatelet     therapy and potentially assess the risk of a recurrent event [6].   "
98942|NCT01991080|"     The immune system plays an important role in the fight against cancer. According to certain     studies, Levels of cytokines secreted by the immune cells were found as predictors of     prognosis and survival among cancer patients, as well as disease recurrence. Previous     studies, including meta-analyses, reported that chronic emotional stress or depression were     associated with higher levels of pro-inflammatory cytokines. Practicing relaxation was found     to decrease psychological symptoms among cancer patients, such as depression, anger,     hostility and anxiety symptoms, as well as physical symptoms.      Wheatgrass juice is an extract squeezed from the mature sprouts of wheat seeds (Triticum     aestivum). Currently, there are only a few laboratory and medical studies that examine the     beneficial effects of wheatgrass consumption. Controlled clinical trials have found that     wheatgrass juice may reduce chemotherapy-induced myelotoxicity, accompanied by fever and     infection without harming the chemotherapy effectiveness among breast cancer patients6.      Aims        1. To examine the differences in immune measures (serum and micro-particles levels of the          cytokines IL-6, IL-8, IL-10 and IL-12), and in physical and psychological well-being          measures (anxiety, depression, pain, fatigue, nausea) at three time points and between          two intervention methods (biofeedback-assisted relaxation and wheatgrass consumption)          and between the intervention groups vs. a control group, among colorectal cancer          patients.        2. To assess the mediating role of optimism, perceived control and well-being measures          (anxiety, depression, pain, fatigue, nausea) among colorectal cancer patients in the          relations between the interventions (biofeedback-assisted relaxation and wheatgrass          consumption) and the immune measures (serum and micro-particles levels of cytokines          IL-6, IL-8 IL-10 and IL-12 ), and the mediating role of well-being measures on the          relations between optimism and perceived control with immune measures.      Methods Participants will include 120 colorectal cancer patients aged 18+, with Eastern     performance status of ≤ 2 and disease stage II or III, who receive adjuvant chemotherapy of     Capcitabine or FU-5 treatment, conjoined with Oxaliplatin, or Capcitabine alone following     curative surgery at Rambam Health Care Campus. The estimated number of participants was     calculated based on Green's equation (1991): 50+8X 7 A comparison between the two treatment     groups, as well as a comparison between each treatment group and the control group (80     subjects) will allow inclusion of up to four background parameters in each of the     regressions, according to Green's equation.   "
98943|NCT01991067|"     Patients undergoing allogeneic blood and marrow transplantation (HSCT) experience a prolonged     period of dysfunctional immunity. Systematic reimmunization is necessary at appropriate time     intervals following transplantation to re-establish immunity. Vaccination practices after     HSCT remain varied and data sparse. Tick-borne encephalitis (TBE) is one of the most severe     infections of the central nervous system caused by a tick-borne flavivirus. There is no     specific treatment, and prevention with the vaccine is the only intervention available. To     assess the efficacy of TBE vaccination in adult allogeneic HSCT recipients compared to an     age-matched and sex-matched control group of healthy volunteers without previous TBE     vaccination, a prospective open-label phase II pilot study on humoral and cellular immune     responses after use of TBE vaccine (FSME Immun) will be performed. As primary end point the     outcome of the neutralization test (NT) against TBE will be assessed in a total of 26 HSCT     patients one year after HSCT and in 26 healthy volunteers, namely four weeks after the second     vaccination. Therefore, the number of subjects with NT titres against TBE virus >10, assumed     to be the threshold for antibody-mediated protection will be evaluated. As secondary     endpoints, antibody concentrations of TBE enzyme-linked immunosorbent assay before and four     weeks after the second and third vaccination and antibody concentrations of NT against TBE     four weeks after primary immunization. To evaluate cellular immune responses, lymphocyte     proliferations assays and cytokine detection assays will be performed. In a subgroup     analysis, these secondary endpoints will be compared between healthy volunteers, HSCT     patients without immunosuppressive treatment and HSCT patients receiving immunosuppressive     agents. Additionally, immune reconstitution by analysis of peripheral blood lymphocyte     subsets and serum immunoglobulin levels will be evaluated prior to vaccination, after twelve     weeks and prior to the third vaccination in HSCT patients only.   "
98944|NCT01991054|"     Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health.     There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2     diabetes.      The purpose of this study is to evaluate the effect of high dose vitamin D supplementation     (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D     deficient patients with non-optimally controlled type 2 diabetes mellitus.   "
98945|NCT01991041|"     This is a registry study, where sites will enter patients with LGS who require a modification     in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change     of one drug to another). This will include patients who are started on rufinamide. Patients     will be reviewed according to local practice, but it is envisaged that review will occur at     approximately one month, three months and six months, and then every six months. Upon entry     to the registry baseline details concerning disease severity, diagnosis, prior therapy, and     developmental assessment will be recorded. On each subsequent visit the patient (usually     through their caregiver) will be asked about current medication, general seizure profile, any     seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related     events), and healthcare resource utilisation.   "
98982|NCT01990560|"     The purpose of this study is to determine whether mifepristone is an effective treatment for     hyperglycemia due to mild hypercortisolism.        -  To test the hypothesis that GR blockade with mifepristone will decrease the severity of          metabolic syndrome features as measured by waist circumference, lipid profile, body mass          index, blood pressure and insulin resistance, measured by HOMA-IR score.        -  To test the hypothesis that GR blockade with mifepristone will improve QoL, depression          and anxiety scores, measured by validated assessments, in patients with mild          hypercortisolism.   "
99134|NCT01988545|"     to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and     cardiac parameters   "
98946|NCT01991028|"     OligoG is a new potential treatment which is being developed by AlgiPharma AS (a     Norwegian-based company) with an aim to help people with cystic fibrosis in the future.      OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to     reduce mucus thickness and improve mucus clearance. It could also have the benefit of     reducing the incidence of infections.      Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three     consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups     tolerated the medication well, with no treatment related issues reported. The dose     administered in this study is lower; patients who complete the study will receive, in total,     186 mg of OligoG in two divided doses.      A new dry powder formulation of OligoG has been developed so that patients can use an     inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is     much quicker and more practical for the patient.      In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and     nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is     a well-established medical imaging technique. A small amount of radioactive material will be     added to both the dry powder and nebulised solution. The radiation emitted will then be     detected by taking images using a device known as a gamma camera. The procedure is relatively     easy and non-invasive.      The purpose of this study is to help answer the following research questions:        -  How do the OligoG dry powder and nebulised solution distribute in the lungs of patients          with cystic fibrosis?        -  How much of the formulation gets to the deep lung?        -  How much of the formulation remains in the devices used for administration?   "
98947|NCT01991015|"     The goal of this study is to better understand gender differences in end-of-life     communication between physicians and patients with advanced cancer in the hospital.   "
98948|NCT01991002|"     The scientific literature shows a quantitative relationship between diet combined with     physical activity as a long term weight reduction modality and an important factor in weight     maintenance.      Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term     maintenance.      Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and     biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.   "
98949|NCT01990989|"     The aim of the present study is to evaluate candidate variables,including Cytochrome P450     2C19(CYP2C19) genotypes, clinical and demographic variables,to establish a simple risk score     that can be easily adopted by clinicians to identify patients who are at risk for HPR and     composite cardiovascular outcomes in Chinese Han patients treated with dual antiplatelet     therapy.   "
98950|NCT01990976|"     The safety of guided practice of physical activity in myopathies is increasingly accepted,     including muscular dystrophies. In facioscapulohumeral dystrophy (FSHD), one of the most     common muscular dystrophy, the aerobic training showed its physiological and functional     efficiency without affecting the quality of life of patients. The issue of exercise therapy     extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use     of a training program combining endurance exercise targeted exercises and strength is even     more relevant.      To complete the multidimensional assessments be managed by each team ( physiological     assessments, functional tissue and quality of life) it is relevant to continue , for a     descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy     (MRI and Nuclear Resonance Imaging (NMR) spectroscopy ).   "
98951|NCT01990963|"     Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using     Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data of     brain tissue after patients with severe brain trauma   "
98952|NCT01990950|"     This post-market study is approved by the US FDA to evaluate the long-term safety and     performance of the Zenith® Fenestrated AAA Endovascular Graft.   "
98953|NCT01990937|"     Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy     ?   "
98954|NCT01990924|"     Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS)     vs. conventional 15 FPS for reduction of operator and patient radiation dose during     diagnostic coronary angiography and percutaneous coronary intervention via the transradial     approach.      Background: Transradial approach for cardiac catheterization is potentially associated with     increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation     exposure.   "
98955|NCT01990911|"     The autonomic nervous system plays an important role in the precipitation of AF in     structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent     new-onset AF.      Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency     energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that     RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and     improvement of diastolic dysfunction follow as a consequence of afterload reduction and     renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial     pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci     originate.      Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by     reducing afterload. These synergistic mechanisms may prevent new-onset AF.   "
99019|NCT01990079|"     The primary goal of the study is to evaluate the use of a new smart phone application in     preventing relapse to smoking among people with PTSD. The technology intervention will     combine a mobile system to reward non-smoking, smoking cessation counseling, smoking     cessation medications, and use of the smart phone app. The primary aim is to evaluate how     effective this intervention is in preventing smoking relapse compared to another intervention     that does not include the app.   "
99086|NCT01989182|"     This is a multicenter, prospective, randomized, controlled study being conducted in China to     evaluate improvement of lung function after treatment with the Spiration Valve System as     compared to medical management in the control group. The control group will be evaluated in     the same manner as the treatment group.      The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the     airways of one lung. It is used to redirect air from the less healthy to the more healthy     parts of the lung. This helps to reduce over-inflation and may improve overall lung function     and quality of life for people living with emphysema.   "
99087|NCT01989169|"     A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in     Healthy Adult Subjects   "
98956|NCT01990898|"     This is a study for patients that have a condition called Interstitial Cystitis, also known     as Painful Bladder Syndrome. Patients would have tried at least two different therapies,     unsuccessfully,(eg. medications, pelvic floor physical therapy)      The purpose of this research project is to study the immunosuppressive drug Cyclosporine in     patients with Interstitial Cystitis to assess how well it works, what the side effects are     and what is its mechanism of action. Cyclosporine is a drug that is FDA-approved to prevent     organ rejection after kidney, liver, and heart transplant but is not approved by the FDA for     Interstitial Cystitis. Several research studies have been published showing that Cyclosporine     can improve the symptoms of Interstitial Cystitis, that it works better than a placebo     (sugar pill or inert treatment) and that it works more effectively than Pentosan     Polysulfate (Elmiron), which is an FDA approved therapy. The dose of Cyclosporine used in     these studies on Interstitial Cystitis are much lower that the doses used to prevent     rejection in transplant patients.      Based on these studies, the American Urological Association has recently published treatment     guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure of     other more conservative therapies and medications. Nevertheless, much is not known about     using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the     ideal dose, how best to monitor for side effects and in particular whether kidney damage can     occur at the low doses used in these studies. In this study, to examine the mechanism of     action, blood and urine samples will be collected before, during and after therapy to look at     biomarkers, chemical substances that can be associated with inflammation and tissue injury.     We will also test effects of therapy on skin sensation and pain perception because the     molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct pain     signals.      This study is only being done at the Cleveland Clinic and will involve about 30 patients with     Interstitial Cystitis.   "
98957|NCT01990885|"     The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single     oral administration and in repeated oral administration to well-controlled celiac patients.     Another purpose is to evaluate if BL-7010 is absorbed by the body or not.   "
98958|NCT01990872|"     This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial (RCT)     aims to examine the impact of various levels of habitual calcium intake on dietary vitamin D     requirements in older adults stratified by calcium intake. This will provide new data on the     impact of different levels of calcium intake, ranging from low/moderate to high, on winter     serum 25(OH)D levels, and their utilization and catabolism in adults.   "
98959|NCT01990859|"     The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese     subjects with advanced melanoma   "
98960|NCT01990846|"     To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat     escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects   "
98961|NCT01990833|"     For non-healing ulcers, abnormal periods of wound healing processes: inflammation,     proliferation and remodelling, are believed to lead to chronic wounds. As a chronic stalled     wound, investigators hypothesized that these glue-assisted closure (GAC)-failed     enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by     excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the     chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.   "
98962|NCT01990820|"     Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease.     Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of     the throat) is performed since the adenoid pad may trap germs that enter a child's body and     can get so swollen with bacteria that they become infected themselves. Functional endoscopic     sinus surgery (FESS) and adenoidectomy are currently the most common surgeries performed on     children with this disease. Another treatment is adenoidectomy and irrigation of the     maxillary sinus without FESS. New technology has emerged using a balloon catheter to dilate     (open) the sinus passage in addition to the adenoidectomy and irrigation. This study seeks to     answer if children with chronic rhinosinusitis who undergo adenoidectomy with balloon     dilation of the maxillary sinus passage and irrigation experience improved quality of life     outcomes compared to children with chronic rhinosinusitis who undergo an adenoidectomy with     maxillary sinus irrigation without dilation of the sinus passage.   "
98963|NCT01990807|"     The cure rate for childhood acute lymphoblastic leukemia (ALL) has increased significantly in     recent decades and expected cure rates now exceed 85%. In recent years, Tyrosine Kinase     Inhibitor(TKI) has improved outcome of Philadelphia chromosome positive (Ph+)ALL . But in     some high risk groups, The prognosis of patients is still very bad and the relapse rate is     high. Clearly, new therapies are urgently needed to prevent and /or treat relapsed ALL.   "
98964|NCT01990794|"     The purpose of this study is to investigate steady-state cobalt levels following dietary     supplementation for 90 days with 1 mg cobalt/day (as cobalt chloride in solution) in healthy     adult volunteers.   "
98965|NCT01990781|"     Post operative sore throat (POST) following tracheal intubation is a common problem causing     dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and     dexamethasone has been used independently for this purpose. However, there is no study     assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The     purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine     dexamethasone combination on the incidence and severity of POST.   "
98966|NCT01990768|"     Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the     prehospital setting in patients with moderate to severe TBI (GCS score ≤12).      Primary hypothesis: The null hypothesis is that prehospital administration either of two     dosing regimens of TXA in patients with moderate to severe TBI will not increase the     proportion of patients with a favorable long-term neurologic outcome compared to placebo,     based on the GOS-E at 6 months.      Secondary aims: To determine differences between TXA and placebo in the following outcomes     for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing     regimens of TXA:        -  Clinical outcomes: ICH progression, DRS at discharge and 6 months, GOS-E at discharge,          28-day survival, frequency of neurosurgical interventions, and ventilator-free,          ICU-free, and hospital-free days.        -  Safety outcomes: Development of seizures, cerebral ischemic events, myocardial          infarction, deep venous thrombosis, and pulmonary thromboembolism.        -  Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway          mediators and degree of clot lysis based on TEG.      Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS     ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg,     prehospital IV or intraosseous (IO) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown),     EMS transport to a participating trauma center.      Exclusion: GCS=3 with no reactive pupil, estimated time from injury to hospital arrival >2     hours, unknown time of injury, clinical suspicion by EMS of seizure activity or known history     of seizures, acute MI or stroke, CPR by EMS prior to randomization, burns > 20% TBSA,     suspected or known prisoners, suspected or known pregnancy, prehospital TXA given prior to     randomization, subjects who have activated the opt-out process when required by the local     regulatory board.      A multi-center double-blind randomized controlled trial with 3 treatment arms:        -  Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram          IV maintenance infusion initiated on hospital arrival and infused over 8 hours.        -  Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo          maintenance infusion initiated on hospital arrival and infused over 8 hours.        -  Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance          infusion initiated on hospital arrival and infused over 8 hours.   "
99034|NCT01989884|"     Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma   "
99078|NCT01989286|"     The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of     this study is to evaluate the spine, the posture and the psychomotor state in children who     were diagnosed with infant plagiocephaly.   "
98967|NCT01990755|"     Background. Treatments of eating disorders result too often in partial psychological and     physical remission, chronic course, dropout, relapse and death, with no fully known     explanations for this failure. In order to clarify this problem, we conducted a three     branches study to identify the biochemical background of cognitive-behavioral psychotherapy     (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy     with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma     homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol     (MHPG) for noradrenalin secretion, and platelet [3 Hydrogen]-Paroxetine-binding Bmax and Kd     for serotonin transporter function. The data were then compared with psychopathological and     physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on plasma     HVA, MHPG and [3 Hydrogen]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging, and 22 BN     inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and     17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine (5 mg/day)     in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated measures for the     changes between basal and post-treatment biological and psychological parameters, two-way     ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups,     Spearman's test for the correlations between basal and final changes in the psychological and     biological scores.   "
98968|NCT01990742|"     One in three Americans dies in a nursing home (NH) or in a hospital, shortly following     transfer from a long-term care facility. The proportion of deaths occurring in NHs is     projected to increase to 40% by 2020. Excellence in palliative and end-of-life (EOL) care     must become a priority for these long-term care institutions. However, findings from NHs     point to high incidence of pain and poor management of other symptoms and excessive reliance     on hospitalizations, indicating inadequate EOL care quality. Expert opinion and research have     suggested that poor EOL quality in NHs may be due to lack of palliative care training among     staff and absence of EOL care protocols or guidelines, but research demonstrating that     attention to these factors improves outcomes is absent. While dedicated care teams have been     shown to improve outcomes for NH residents in need of specialized care, the impact of     palliative care teams in improving resident outcomes has remained largely unstudied and     untested. This will be the first randomized controlled trial to evaluate the impact of     palliative care teams (PCTeam) on resident and staff outcomes, and care processes, in NHs.      Our objective is to demonstrate, using a randomized controlled trial design and a difference     in difference analytic approach, that nursing home-based palliative care practice guidelines     implemented through PCTeams will improve quality of care processes and outcomes for residents     at the end of life.      We will adapt existing palliative care guidelines for EOL care, endorsed by the National     Quality Forum (NQF), to the NH environment, deploy the adapted practice guidelines through a     PCTeam model, and evaluate the effectiveness of this intervention on resident EOL outcomes     and staff care processes and outcomes. The specific aims (SA) will address the following     questions:      SA 1: Is PCTeam intervention effective in improving NH residents' EOL outcomes?      SA 2: Is PCTeam intervention effective in improving NH staff EOL care processes and outcomes?      In the context of these specific aims we will test the following hypotheses:      H1: Residents in NHs in the intervention arm, compared to the control, will achieve better     EOL risk-adjusted outcomes and care processes with regard to:        -  Pain        -  Dyspnea        -  Depression        -  In-hospital deaths        -  Hospitalizations        -  Advance directives      H2: Direct care staff in NHs in the intervention arm, compared to the control, will achieve     better EOL processes and outcomes measured by:        -  Assessment of EOL symptoms        -  Delivery of EOL care        -  Communication/coordination among providers        -  Communication with residents/families        -  Teamwork effectiveness        -  Staff satisfaction      H3: Family caregivers of decedent residents in the intervention NHs, compared to the control,     will report receiving more patient and family centered care as measured by higher levels of     satisfaction with:        -  Shared decision making between providers, the patient and the family        -  Care that is respectful of the patient wishes and dignity        -  Attention to the emotional and spiritual needs of the family.           31 NHs in upstate New York have been recruited for the study (letters of support).          Stakeholders include residents, family members, staff, policy makers, and others. The          intervention will deploy theTeamSTEPPS, a team development model created by the          Department of Defense and the Agency for Healthcare Research and Quality.   "
98969|NCT01990729|"     To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment     of non-specific low-back pain of lumbosacral localization in ambulatory care.   "
98970|NCT01990716|"     We will quantify one of the lipid compounds (5,6 epoxy eicosatrienoic acid (5,6 EET), 5,6-     EpoxyEicosaTrienoic acid) in colonic biopsies of Inflammatory Bowel Disease patients. We will     evaluate its possible use as a pathological activity biomarker and its potential as a     therapeutic target.      We hypothesized that 5,6-EET is present in human colonic tissues in varying quantities     depending on the pathological state of the IBD patient.   "
98971|NCT01990703|"     We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth     on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish     to breastfeed, and are willing to participate in the study will be randomly assigned to     either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks     later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery     between those who get the IUD placed early or later.   "
98972|NCT01990690|"     To predict the effect of antioxidants in cases of oligohydramnios   "
98973|NCT01990677|"     To test the effect oral eplerenone versus placebo in patients with central serious     chorioretinopathy .   "
98974|NCT01990664|"     This study is an open-label, multi-site study. The total number of subjects was 200. The     duration of this study was approximately four weeks. The primary objective was to assess what     percentage of lapsed contact wearers, who have discontinued use of their contact lenses for     greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly     replacement daily wear lenses (spherical and toric designs).   "
98975|NCT01990651|"     The purpose of this study is to assess whether the detection of circulating tumor cells (CTC)     could be used as a tool to earlier diagnose, more accurately predict treatment response /     failure and predict overall survival in non-small cell lung cancer (NSCLC) patients   "
98976|NCT01990638|"     The purpose of this study was (1) to compare the peak exercise capacity and left ventricular     diastolic function between patients with and without diabetes and (2) to investigate the     interrelation among peak oxygen consumption, left ventricular diastolic function, blood     sugar, and lipid profile.   "
98977|NCT01990625|"     In many low-income countries, the use of ultrasound by medical officers and non-physician     health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a     new intervention requiring authoritative investigation. The primary hypothesis to be assessed     in this study is that antenatal ultrasound screenings performed by medical officers and     non-physician health care staff will significantly reduce a composite outcome consisting of     maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource     settings. Underpinning this hypothesis are two assumptions. The first assumption is that     antenatal detection of complicated pregnancies will lead to appropriate referral at the right     time for complicated pregnancies to comprehensive emergency obstetric and neonatal care     (EmONC) facilities. The second assumption is that ultrasound's introduction will increase     antenatal attendance leading to greater rates of institutional delivery. To assess these     underlying assumptions beyond the composite end point, this study will investigate the health     system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates,     institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC     facilities, cesarean section rates (both planned and emergent) and an assessment of medical     officers and non-physician health care provider ultrasound competence and training quality.   "
98978|NCT01990612|"     A randomized clinical trial to assess whether elective induction of labor at 39 weeks of     gestation compared with expectant management will improve outcomes.   "
98979|NCT01990599|"     Airway management of patients undergoing thermal coagulation of the Gasserian ganglion is     very delicate. This is because of the specific operation site and moreover patients should     recover quickly from anesthesia to follow verbal intraoperative commands of the surgeon.     Endotracheal intubation or laryngeal mask of course hinders the patient from speaking. An     obvious alternative airway management, as performed in this preliminary study, is a     nasopharyngeal placed tube.      The purpose of the present study is to objectify the gas exchange in patients during this new     ventilation technique.   "
98980|NCT01990586|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release     Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period     during fed study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
98981|NCT01990573|"     Three arm randomized controlled trial to evaluate the efficacy of a single dose of     intraoperative methadone in reducing post-operative pain and opioid consumption in     adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the     pharmacokinetics of IV methadone in children (0.4 and 0.5 mg/kg).   "
98983|NCT01990547|"     The main purpose of this study is to determine whether functional magnetic resonance imaging     (fMRI), can distinguish between service members with and without traumatic brain injury     (TBI), as well as those with posttraumatic stress disorder (PTSD) who receive either virtual     reality exposure therapy (VRET) or PTSD treatment other than exposure therapy. The     investigators and other investigators have previously identified changes in function in     multiple regions of the brain in combat veterans with PTSD, and the investigators have also     seen that structural changes in the white matter associated with combat TBI are also linked     with changes in function, and in turn with PTSD symptoms. However, the investigators need to     confirm these findings in larger numbers, and also need to discern whether fMRI can     distinguish if there is something significantly different about those who have PTSD after TBI     vs. those in whom it does not follow a TBI. Finally, the investigators have previously     demonstrated that exposure therapy ameliorates the functional changes in the brain induced by     PTSD, but the investigators do not know if similar changes occur with other forms of therapy,     so the investigators seek to compare the two directly. It is our expectation that the     findings will better inform the choice of therapy for service members with combat-related     PTSD, with or without TBI.   "
98984|NCT01990534|"     This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy     and safety of brentuximab vedotin as a single agent in adult participants with histologically     confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma who have not received a     prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or     multiagent chemotherapy at the time of study entry.   "
98985|NCT01990521|"     Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate     cancer compared to men in the general population.      Standard of care screening for men with a BRCA mutation includes PSA testing and digital     rectal examination (DRE), the same as with men in the general population.      This study is being done to assess whether there is value in using MRI as a screening tool to     detect prostate cancer at an earlier stage than may otherwise be detected using standard of     care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this     specific population at high risk for aggressive disease.   "
98986|NCT01990508|"     Approximately 15% of the US population is enrolled in the Supplemental Nutrition Assistance     Program (SNAP), and 50% are children. Although the goal is to improve nutritional health,     preliminary data suggest that enrollment in SNAP is associated with obesity and metabolic     risks and that SNAP reimburses $4 billion annually for sugar-sweetened beverages (SSBs). This     pilot project tests an innovative strategy to reduce purchase of non-nutritive, SSBs by     low-income families with children by combining targeted point-of-purchase education with a     randomized trial of financial incentives to discourage purchase of unhealthy beverages. The     study will take place at a mid-size grocery store that is located in a low-income, Latino     community and where 30% of purchases are made with SNAP. Targeted beverage education will be     provided to all study subjects with a traffic-light system to identify healthy and unhealthy     beverages at the point-of-purchase. Individual beverage purchases will be tracked by     electronically stored cash register sales. Supplementary validation of beverage consumption     will be assessed by 24 hour dietary recall. Aim 1 is to conduct a randomized controlled trial     to compare purchase and consumption of SSBs by families assigned to a financial incentive to     reduce purchase of SSBs with families assigned to control (no incentives). Aim 2 is to     compare the purchase of SSBs by families in both arms during the study period when they are     exposed to the traffic-light system to a baseline period prior to traffic-light education.     Results of this project will provide pilot data for larger scale interventions to promote     healthy choices among low-income families.   "
98987|NCT01990495|"     The majority of individuals with advanced ESRD have reduced exercise capacity in part due to     decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater     incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of     muscle mass in ESRD are not understood very well. This study is designed to determine the     effectiveness of an exercise program on improving muscle mass, exercise capacity and quality     of life in persons with ESRD. In addition, the study will attempt to better understand why     muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and     whether the response to exercise can be enhanced with nutrient supplementation.   "
98988|NCT01990482|"     A delay in the return of normal bowel function with the passage of flatus and feces is one of     the most important factors affecting early recovery and discharge in patients undergoing open     complete staging surgery for gynecological malignancies. A prolonged hospital stay increases     the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and     total hospital costs.      The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel     function in patients undergoing abdominal complete staging surgery for gynecological     malignancies.   "
98989|NCT01990469|"     After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in     a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing     stable doses of glimepiride in combination with metformin for 24 weeks.   "
99035|NCT01989871|"     The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting     from transition to oral feeding (33 weeks corrected age) will result in less episodes of     apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten     hospitalization duration in the short term.      In the long term AIF will result in higher scores on the Griffith's developmental scales,     decreasing parental anxiety and feeding disorders .   "
99118|NCT01988766|"     The purpose of this study is to compare the difference in thrombosis as a result of internal     jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is     hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ     catheters verses PICC lines.   "
99088|NCT01989156|"     Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk     Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by     apparently adult healthy smokers results in a reduction in the levels of biomarkers of     exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).   "
99089|NCT01989143|"     This single and multiple ascending dose study is a first in human assessment of PF-06480605.     The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.   "
98990|NCT01990456|"     Due to lack of studies on mechanical ventilation strategies in patients with severe Acute     Respiratory Distress Syndrome (ARDS) supported with Veno-Venous Extra-Corporeal Membrane     Oxygenation (VV ECMO), ventilator settings in this patient population are set arbitrarily.      In this two-phases prospective, interventional, pilot study we hope to gain physiologically     relevant data on two aspects of mechanical ventilation in patients with severe ARDS supported     with VV ECMO: (1) the use of tidal ventilation and (2) the level of Positive End-Expiratory     Pressure (PEEP).        1. PHASE 1: impact of tidal ventilation on VILI (10 patients) We hypothesized that a CPAP          strategy that minimizes end-tidal pulmonary stress and strain mitigates VILI compared to          the current mechanical ventilation practice that employs tidal ventilation in patients          with severe ARDS on ECMO.           In this first phase we will test whether administering a distending inspiratory pressure          to produce tidal ventilation is superior to a strategy where only continuous positive          airway pressure (CPAP) is applied for ventilation induced lung injury (VILI) mitigation,          as assessed by its impact on biotrauma (serum cytokines) and physiologic measurements.        2. PHASE 2: impact of PEEP on VILI (10 patients) We also hypothesized that adjusting PEEP          to maximize respiratory system compliance reduces VILI in patients with severe ARDS on          ECMO.      In the second phase we will therefore gain more insight as to whether a strategy that     utilizes a PEEP level that correspond to best compliance is beneficial over Zero     End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma     (serum cytokines), physiologic parameters, and right ventricular function (transesophageal     echocardiographic assessment).      Because ARDS patients supported with VV ECMO can be hemodynamically unstable, the use of     imaging techniques that require transport, such as computed tomography, is limited.     Therefore, bedside imaging techniques, such as pleural and lung ultrasound (PLUS) and focused     bedside cardiac ultrasonography, are important tools for clinicians who care for these     patients. This study will allow us to learn whether these techniques are feasible and valid     in this patient population.      Furthermore, the knowledge gained from this study will allow us to assess the rationale and     feasibility of performing a similar larger, randomized study in the future.   "
98991|NCT01990443|"     The primary objective of this study is to assess the absolute bioavailability of reslizumab     following administration of a single subcutaneous (sc) dose to healthy non-Japanese     participants   "
98992|NCT01990430|"     Exercise training has been established as a feasible and safe intervention during or after     neoplastic treatment in breast cancer patients. Numerous studies have shown that exercise can     prevent and control various treatment-related side effects including functional limitation,     physical capacity, anxiety and sleep disturbance. In the long-term, an active life style has     been demonstrated to increase survival in women, who maintain a moderate level of exercise     per week (30 or 75 minutes of brisk walking 5 days per week).      Specifically, active breast cancer survivors have a 51-85% lower cancer specific mortality     and 33-82% lower all cause of mortality. But despite this, most breast cancer patients reduce     their physical activity levels during and after cancer treatment. In 2010, a roundtable     meeting of American College of Sport Medicine published guidelines for cancer survivors,     defining that the recommended amount of exercise was 150 minutes per week of aerobic exercise     of moderate-intensity and 2 or 3 days per week of strength training that included exercise     for major muscle groups. But only 30-47% of breast cancer survivors follow these exercise     recommendations.      In most clinical settings, information by the oncologist to keep physical active is part of     the recommendation. Yet some breast cancer patients find it difficult to begin or maintain     the minimal activity levels recommended by the experts. A typical obstacle includes lack of     directions from experts, which can assure the safety and feasibility of the exercise that     they perform. Moreover, important personal aspects can have major influence on the exercise     preference, including certain food choice and dietary intakes, education level or the     preference of a face-to-face exercise counseling by a professional.      A cancer diagnosis is recognized as teachable moment, where patients are particularly     motivated for lifestyle changes. So it is important to approach the patients with adequate     interventions that consider the different needs in order to get a healthier behavior among     the breast cancer patients.      Taking this into account, the hypothesis of this pilot project is that a guided integrated     group exercise program, which includes an educational program on healthy life style, will     increase the adherence of breast cancer survivors to exercise and a healthy diet. Therefore     the aim of this pilot study was to investigate if a comprehensive and specific group exercise     program, which includes dietary and exercise information, could increase leisure-time     exercise in women with breast cancer.   "
98993|NCT01990417|"     The present study aimed to analyze the influence of passive stretching before and after     strength training on flexibility of the hamstrings in people who work out   "
98994|NCT01990404|"     Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and     oxygen is used in the emergency medical care of the trauma, burns, during transport of     patient with pain. None randomized study has validated the use of premixed nitrous oxide and     oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the     efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with     out-of-hospital severe acute pain   "
98995|NCT01990391|"     The purpose this research is to check the effect of Brazil Nuts consumption in oxidative     stress, metabolic abnormalities and microvascular endothelial function dyslipidemic and     hypertensive patients.   "
98996|NCT01990378|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release     Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period     during fasted study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
98997|NCT01990365|"     Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low     back pain. But there are only part of patients with acute OVFs, because some patients do not     have low back pain although OVFs occurred.   "
98998|NCT01990352|"     Primary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on     response when metastatic breast cancer patients are treated with DNA damaging chemotherapy     agent, compared to historical controls      Secondary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on     tumor progression when metastatic breast cancer patients are treated with DNA damaging     chemotherapy agent, compared to historical controls   "
98999|NCT01990339|"     To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic     improvement in gastroesophageal reflux disease patients with dyspepsia symptoms   "
99000|NCT01990326|"     This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on     excess submental fat, also known as double chin. The study will also assess the safety and     tolerability of XAF5 Gel.   "
99001|NCT01990313|"     The purpose of this study is to provide objective measurements of abnormal movements of the     body in correlation with neural activity of the brain and track how these change over time.     This may allow for the development of objective evaluation of the neural activity causing     abnormal movements, which may lead to the ability of the DBS system to stimulate the brain by     sensing the abnormal neural activity that is causing abnormal movements.   "
99002|NCT01990300|"     The purpose of this study is to examine the safety and efficacy of long-term use of     alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus     determined as warranting combination therapy with alogliptin benzoate and pioglitazone     hydrochloride   "
99003|NCT01990287|"     The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation     with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.   "
99258|NCT01986907|"     The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients     affected by wet age related macular degeneration (wAMD).   "
144656|NCT01390961|"     Comfort is compared between two allergy drops   "
99004|NCT01990274|"     The purpose of this study is to compare two different methods of intensified tuberculosis     (TB) case finding in the community. These methods all involve the use of a mobile clinic to     reach people with TB symptoms who are not able to readily access clinic services. A standard     diagnostics package consisting of smear microscopy and culture (with smear result available     the next day) will be compared with a novel diagnostics package involving point-of-care     sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result),     sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects     only). The primary outcome is a comparison between the number of culture +ve subjects on TB     treatment in each group at the end of two months. A secondary aim is an evaluation of the     accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims     include using chest X-rays obtained during the study to develop and validate of an     computer-aided diagnosis (CAD) software package for TB (together with collaborators in the     Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations     in the urine of those with TB.   "
99005|NCT01990261|"     This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR)     participants treated with Tarceva after at least one failed chemotherapy treatment, and the     impact of prior chemotherapy treatments.   "
99006|NCT01990248|"     This multi-center, prospective, observational safety study will evaluate the safety and     effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated     patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be     collected for 2 years.   "
99007|NCT01990235|"     The objective of this proposal is to test whether a multi-media website     (www.prepareforyourcare.org) that is focused on preparing older adults for communication and     medical decision making can help people engage in advance care planning.   "
99008|NCT01990222|"     The goal of this study is to develop and test a mobile web application to optimize early     stimulant medication treatment for children receiving care for Attention/Deficit     Hyperactivity Disorder (ADHD) in a publicly-funded mental health clinic.   "
99009|NCT01990209|"     The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75     percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may be     a target in patients with advanced breast cancer. Breast cancer patients whose tumors do not     express the ER, PR or HER2 (triple negative) have very few options for treatment. Orteronel     is being developed as an endocrine therapy for relevant hormone-sensitive cancers such as     prostrate cancer and breast cancer. Triple-negative metastatic breast cancer patients with AR     expression could potentially benefit from anti-androgen therapy like orteronel.   "
99010|NCT01990196|"     Prostate cancer is the most common cancer in men and the second leading cause of cancer death     in men. The purpose of this research study is to compare prostate cancers treated with     hormone therapy versus prostate cancers treated with hormone therapy plus drugs that directly     target cancer cells.   "
99011|NCT01990183|"     Stroke and other neurological conditions affect the population of infants in percentages that     cannot be considered marginal. Preterm infants are the highest infants at risk for     neurological damage. Currently, infants have rehabilitation sessions few times a week in     rehabilitation centres but according to basic neuroscience it would be necessary to provide     them with an early, intensive and multiaxial intervention. One option to reduce the cost of     the entire European Healthcare System while increasing the practice of rehabilitation is to     devise therapies and technologies that can be administered at home by caregivers and     telemonitored by rehabilitation staff. The aim of this proposal is to promote early     intervention in the first year of life and to reinforce therapy by CareToy: a portable low     cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy     while reducing the cost. The smart system is based on a common baby gym, composed of     different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the     infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring     and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and     promoting postural control. Each module will also incorporate built-in signal processor,     memory and wireless communication. A fourth telerehabilitation module completes the system     that allows the system to remotely communicate with the rehabilitation staff for monitoring     and assessing the rehabilitation techniques. CareToy and the effectiveness of home     rehabilitation based on this system will be validated by clinical trials on at least 50     preterm infants. The result of this project could have a large impact. CareToy may become a     commercial product, manufactured on a large scale and distributed not only in rehabilitation     centres but also at homes, sold or rented by the Health Care System to families as a     therapeutic tool for care intensity.   "
99012|NCT01990170|"     The purpose of this study is to determine long term healing rates of chronic venous ulcers     (CVU) after ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR)     and to relate recurrence of CVU to evidence of recanalisation and the presence of superficial     or deep venous reflux   "
99013|NCT01990157|"     This study is in two stages:      Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in     patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough     effective.      Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected     TAB08 dose in extended patient population with active Rheumatoid Arthritis in which     methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.   "
99014|NCT01990144|"     The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine     (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as     frail according to CGA.   "
99015|NCT01990131|"     The purpose of this study is to test the effectiveness and usability of multiple     computer-based treatments for mood and anxiety relevant risk factors. The target of the     treatment is related to cognitive stress, which has been shown to be associated with a     variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal     ideation, and substance use disorders.   "
99016|NCT01990118|"     The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the     standard treatment Neoral® for a treatment period of 6 months in stable renal allograft     transplant recipients with respect to drug levels, dosage, and acute graft rejection and     other adverse events.   "
99017|NCT01990105|"     FINFIB 2 is an observational investigator-driven study that seeks to examine current     treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that     the treatment of atrial fibrillation has improved since the introduction of new     antiarrhythmic drugs and anticoagulants.   "
99018|NCT01990092|"     The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and     nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic     peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks     of treatment, and long-term effects will be evaluated over the duration of a 48 week     treatment period.   "
99020|NCT01990066|"     Implementation of a home based exercise program to reduce functional decline, cancer related     fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient      Problem:      Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology     patient undergoing chemotherapy?      Support:      Fatigue and its impact on QOL is a major concern with the elderly patient receiving     chemotherapy. When compared to younger adults QOL is more important than gain in survival for     elderly patients. (Eyigor, et al., 2010).      The National Comprehensive Cancer Network recommends exercise as the most effective     intervention for cancer related fatigue.      Methods:      This is a single institution randomized controlled study to evaluate a home based exercise     program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be     randomized to the intervention group or to the control group receiving usual care.      Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of     strength and aerobic activity, utilizing a follow along exercise DVD and patient log to     assist with compliance.      The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6     minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the     NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment     of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following     cycle 6 (completion).      Conclusion:      PT directed home exercise program may improve CRF, functional decline, and QOL in elderly     gynecologic oncology patients undergoing chemotherapy.   "
99021|NCT01990053|"     Standard treatments for depression in specialty care settings are effective but resources for     delivering empirically supported psychotherapies are often limited. Computerized cognitive     behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that     might help expand services in psychiatric settings, however, little is known about its     efficacy in this population. The present study aims to establish the efficacy of a     internet-delivered cCBT program (Beating the Blues) plus email and telephone support for     depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an     assessment procedure designed to identify moderators of treatment effectiveness.   "
99022|NCT01990040|"     This is a global prospective, observational, multi-center registry to evaluate the long-term     safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide     in a routine clinical setting. The registry will also evaluate the long-term clinical     outcomes in patients with SBS. SBS patients treated and not treated with teduglutide will be     enrolled.   "
99023|NCT01990027|"     The SKSC is a continuous database with the objective of a standardized diagnosis and     monitoring of patients with kidney stones as well as the establishment of a Biobank.   "
99024|NCT01990014|"     The objective of this protocol is to evaluate the quality of life and functional disability     in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke     who received a decompressive craniotomy in the acute phase. Patients who have given their     consent to be evaluated at least two years after their stroke and their operation in a single     visit by clinical examination and procurement of standardized scales. Will be measured the     quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of     life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The     existence of predictive parameters of long-term evolution will be searched in determining the     existence of a correlation between demographic data and baseline characteristics of the     stroke on and the evolution of the quality of life.   "
99025|NCT01990001|"     The broad objective of this research is to determine whether a quick, simple intervention     will increase utilization of contraceptive reminders and adherence to short‐term     contraceptive regimens. Such an intervention could be implemented easily with no additional     resources into a busy clinical practice.   "
99026|NCT01989988|"     The investigators would like to conduct a randomized clinical trial to compare the efficacy     of diabetes treatment between different gastric bypass procedures involving type 2 diabetics     patients with BMI from 27.5 to 35 kg/m2   "
99027|NCT01989975|"     The purpose of this study is to evaluate the performance, patient satisfaction and safety of     connectivity gateway device CareLink Connect, transferring CGM data from a VEO insulin pump     to CareLink online (every 5th minute) and thereby making it available for patients or Care     Partners individual web connected devices such as smartphones, tablets and PCs.   "
99028|NCT01989962|"     Education for Equity (E4E)intervention intends to improve care delivery through a well     designed educational program that address not only the issues of diabetes care delivery to     Aboriginal patients with diabetes, but also the issues of effective cross-cultural and     culturally safe communication between healthcare providers and Aboriginal patients, and the     issues related to effective implementation of appropriate chronic disease management programs     for Aboriginal patients in a range of practice settings. The purpose of this study is to     evaluate the effectiveness of the E4E education program through measuring patient clinical     outcomes, patient experience with their doctors, and the changes in physicians' approaches to     care perceived by Aboriginal diabetic patients.   "
99029|NCT01989949|"     This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult     subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving     seven (7) doses of 1.0 mg/kg IV TP-434.   "
99030|NCT01989936|"     To determine the tolerability and efficacy of eletriptan in patients who had discontinued     oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous     clinical treatment (not a controlled trial).   "
99031|NCT01989923|"     This feasibility study will compare two smoking cessation methods, traditional nicotine     replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in     patients with gynecological conditions.   "
99032|NCT01989910|"     A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based     combination therapy in treatment-naïve patients with HIV-1 infection.   "
99033|NCT01989897|"     This is a double-blind study with respect to the diluents used, with patients known to be     allergic to the specific allergen tested. Three study sites will be involved, each testing     one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the     allergen in question will be tested with serial three-fold dilutions to determine the ID 50     and relative extract potency using the method described by Turkeltaub.   "
99036|NCT01989858|"     The study addresses two primary questions, according to its factorial design:        -  to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a          post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a          post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study);        -  to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical          CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX          Study).      The study has a 2x2 factorial design, thus consisting of two independent, following specific     eligibility criteria and with different randomization scheme studies, the Timing Study and     the RTX Study.      Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials     conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which     is considered operable.      In the Timing Study patients fulfilling the eligibility criteria will be randomized with a     1:1 ratio to receive:        -  peri-operative CHT (Arm A) or        -  post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be          randomized in the RTX      Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other treatment.     This is possible since the randomization will be done in two steps: the first for the Timing     Study for all the participating centres (peri-operative CHT vs. post-operative CHT) and the     second one for the RTX Study, only for those centres with the radiotherapist willing and able     to participate (post- surgical CHT-RTX vs. no other treatment). Thus the following four arms     will be generated:        -  peri-operative CHT (Arm A)        -  post-operative CHT (Arm B)        -  peri-operative CHT + post-operative CHT-RTX (Arm C)        -  post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more          than one hundred experimental centres. Follow-up F(-up) procedures and timing of the          visits will be consistent with current clinical practice.      Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in     the RTX study.   "
99037|NCT01989845|"     Rivaroxaban has been developed in the various clinical settings, prevention of venous     thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial     fibrillation, and in the treatment of acute coronary syndromes. And, in the     EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs,     rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT. However,     there has been limited experience of rivaroxaban with secondary VTE prophylaxis in cancer     patients. Although cancer-associated DVT or PE was included in previously mentioned EINSTEIN     programs, only approximately 5% of the total populations were cancer patients in these     studies. Thus, investigators could not automatically translate the results of these studies     into the real practice management of cancer-associated VTE patients. Moreover, until now, new     oral anticoagulants, including dabigatran and rivaroxaban, have been compared to long-term     warfarin therapy, which were well-known inferior agent, but not low molecular weight heparin.     In this sense, investigators feel that new oral anticoagulants, particularly rivaroxaban,     should be re-investigated in this highly specific patients group. Therefore, investigators     are planning to conduct a prospective study evaluating the efficacy and safety of rivaroxaban     in Korean patients with cancer-associated VTE.   "
99038|NCT01989832|"     The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized     use of immunosuppressive drugs. However, graft survival at ten years has not improved since     then; this may be explained in part by the toxicity of these drugs, viral infections, and     other comorbidities (diabetes, cardiovascular diseases …).      According to transplant center, strategies for the combination of immunosuppressive drugs are     different, and probably involve a difference in the global cost of patient management. There     is no recommendation in France to establish similar practices.      EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal     transplant patients.   "
99039|NCT01989819|"     Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often     involving the central and peripheral nervous systems. Fifteen to twenty percent of patients     with the primary Sjögren's syndrome have neurological complications involving the peripheral     nervous system. Although some patients have large fiber neuropathy, around forty percent of     patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic     studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms,     some have been shown to have small fiber neuropathy (SFN). A recent study proved that more     than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.      The aim of this study will be to investigate the occurrence of small fiber neuropathy in     patients with pSS and neuropathic pain with normal electromyographic studies and to determine     the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or     auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is     a valuable tool to diagnose small fiber neuropathy and the method has been widely validated.     A skin biopsy will be performed in patients and control and will allow quantification of     small fiber density in skin sample along with measurement of sweat gland innervation.     Moreover, pathophysiological studies will be carried on in order to evaluate the causal     relationship between cellular and humoral inflammation and small fiberneuropathy.      Recent studies have pointed out the inconstant efficacy of both corticosteroid and     immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small     fiber neuropathy in these patients may help designing new therapeutic strategies.   "
99040|NCT01989806|"     Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility and     higher chance to develop cardiopulmonary diseases, which leads to poor quality of life and     shorter life expectancy. Different modalities were developed aiming at mobility restoration     in SCI patients and robotic assisted body weight supported treadmill training is one of the     latest technique in recent years. Yet there are scarce studies to investigate its     effectiveness. The purpose of this study is to investigate the effectiveness of     robotic-assisted body weight supported treadmill training on mobility and cardiopulmonary     function of patients suffering from SCI by a randomized controlled trial.      80 patients suffering from incomplete SCI will be recruited for an 8-week training program.     They will be randomized into either robotic assisted body weight supported treadmill training     group or passive lower limb mobilization training group. The training effects will be     measured by Walking Index for Spinal Cord Injury version II, lower extremity motor score,     lower limb Modified Ashworth Scale, robotic gait system, gait analysis and gas analysis under     sub maximal exercise stress test.      Through the study, we intent to find the effectiveness of robotic-assisted body weight     support treadmill training on walking and cardiopulmonary recovery with patients suffering     from incomplete spinal cord injury.      The hypothesis of the study is:      Compared to the control group, robotic-assisted body weight supported treadmill training     leads to a greater improvement in walking ability and cardiopulmonary functioning.   "
99119|NCT01988753|"     This study is being conducted to develop new techniques for early diagnosis of liver disease.     These techniques are: Shearwave Elastography (SWE) ultrasound and blood biomarkers.      SWE ultrasound uses high-frequency sound waves to view soft tissues such as muscles and     internal organs and measure stiffness. An ultrasound creates computer images that show     internal body organs, such as the liver or kidneys, more clearly than regular x-ray images.      Biomarkers are biological molecules found in the blood that provide important information     about liver disease.   "
99041|NCT01989793|"     This research study is being done to see whether losartan can prevent the decrease in     strength associated with aging.      Muscle loss is associated with aging and has multiple symptoms such as weakness, slowness,     and fatigue (tiredness). Older adults with muscle weakness have a higher risk of falls and     disability. In addition, the loss of independence for older adults can lead to a poorer     quality of life.      Recently, it was discovered that losartan, a medication commonly used to treat high blood     pressure, had slowed the strength decline seen in older mice. In addition, it allowed injured     mice skeletal muscle to heal faster. Therefore, we would like to see if losartan can do the     same for older adults.      Losartan is approved by the Food and Drug Administration (FDA) for the treatment of high     blood pressure, heart failure, and to protect the kidneys in diabetic patients. Losartan is     not FDA-approved to prevent the decrease in strength associated with aging.      In this study, participants age 70 and older will be asked to take losartan or a placebo to     see if losartan can help prevent loss of muscle strength. A placebo is a substance that looks     like the study drug but that contains no active ingredients.   "
99042|NCT01989780|"     To evaluate optimal usage of bevacizumab to compare which is better, continuing bevacizumab     and paclitaxel or switching to hormonal maintenance therapy followed by     bevacizumab+paclitaxel after induction therapy of bevacizumab+paclitaxel.      To examine biomarkers such as monitoring markers of study treatment as exploratory analysis.   "
99043|NCT01989767|"     The hypothesis was that education of rehabilitation officers who were responsible for     rehabilitation back to work for sick-listed individuals in screening for mental disorders and     psychiatric topics would increase the rate of return to work and reduce the number of     sicklisted days   "
99044|NCT01989754|"     The purpose of this study is to assess the effect of canagliflozin compared to placebo on     progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard     care but with inadequate glycemic control and at elevated risk of cardiovascular events.   "
99045|NCT01989741|"     -  hypothesis: sleep restriction in healthy subject trigger alteration of decision making          associated with immuno-inflammatory changes        -  inclusion criterias: healthy subjects, men, under 35 years, BMI<26, no sleep troubles,          intermediate chronotype        -  design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction          (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).        -  parameters: decision making tests, reaction time, wakefulness test, biological          parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure        -  control of sleep restriction: continuous polysomnographic survey   "
99046|NCT01989728|"     The hypothesis was that a large fraction of individuals with common mental disorders were     undetected in long-term sickness and that detection of the disorders by screening, a     psychiatric diagnostic examination and feedback to the individuals, primary care, and     rehabilitation officers improved return to work, improved quality of life and reduced     psychological distress.   "
99047|NCT01989715|"     Postural balance on both feet, characteristic of the human species, is possible by the     tension of muscle of the whole body from toes to head.      Body position depends on many inputs such as vision, vestibule, skin receptors, states of     muscle tension receptors. Information is integrated in a complex nervous system via the     ascending and descending pathways. The information is then analyzed to provide feedback on     body position. Any variation of body position, induces a variation of the center of pressure.     Impaired body positioncan cause pain (back pain, neck pain) or long-term deformation     (including scoliosis or kyphosis).      Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle     chain that controls posture. Incorrect positioning of the jaw in the three directions of     space seems to create an asymmetric masticatory muscles activity and thus destabilize the     muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery     could alter the body posture via changing the activity of the masticatory muscles.      However, nowadays no clear link has been demonstrated between maxillas repositioning and body     posture modification.      The purpose of this study is to highlight the link between posture and jaws position, by     analyzing the variation of the masticatory muscles activity and, the changes in body center     of pressure before and after orthognathic surgery of jaws standardization.      In this study each patient will be evaluated in terms of occlusion and body posture before     surgery and after surgery (2 months) by the same protocol. The surgery will be performed in     the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry     department - Prof. Salvadori La Timone Hospital, Marseille.      The assessment includes the body posture study with a stabilometric platform (eyes open /     eyes closed and with / without tooth contact), and analysis of the head orientation relative     to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact ) are     devoted to check the evolution of the developed forces, and hand strength will be recorded     using a dynamometer.      All these data will be recorded for all the patients. Patients will be divided into four     subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular     retrognathia and (4 mandible repositioning.      Statistical analysis is aimed at validating or not the hypothesis of changes in body posture     caused by surgical maxillas repositioning.   "
99048|NCT01989702|"     The aim of the present study was to examine the efficacy of a probiotic-based product on     either reducing hypertension or preventing a high normal blood pressure from reaching     hypertensive levels.   "
99049|NCT01989689|"     The investigators plan to measure the health of the vascular system of subjects taking     Etanercept for the treatment of plaque psoriasis.   "
99050|NCT01989676|"     The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of     PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union     (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast     cancer in the first-line treatment setting. The hypothesis to be tested in this study is that     the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.   "
99051|NCT01989663|"     This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial     assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will     be randomized to gel or film, tenofovir or placebo. This study will provide additional     information in the evaluation of vaginal films containing microbial agents in humans. In     addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy     challenge model will be compared.      This study is the first study assessing the safety of tenofovir film in humans. Tenofovir     film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl     cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose     (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical     settings.      While the tenofovir film has not been studied extensively in preclinical studies, there are     favorable safety data from the macaque study and a substantial body of research with     tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical trial     for the following reasons:        -  No safety concerns were note in the tenofovir film macaque trial.        -  The toxicity of tenofovir administered vaginally has been studied extensively. No          clinically significant toxicity associated with this route of administration has been          observed to date.        -  All of the active ingredients of the tenofovir film have been tested in pre-clinical          toxicity studies; therefore, the influence of these ingredients on the toxicity profile          of tenofovir has been adequately evaluated and has been shown to result in no local or          systemic effects.        -  The individual components of the tenofovir film have been adequately evaluated and have          been shown to be safe.   "
99052|NCT01989650|"     Recent research has suggested that endoscopist fatigue may significantly affect the polyp     detection rate. There have been no studies on interventions that may reduce endoscopist     fatigue and therefore improve colonoscopy performance.      We want to determine whether a break in the middle of colonoscopy session would maintain a     more stable adenoma detection rate   "
99053|NCT01989637|"     It is important to identify and evaluate foods, such as strawberries, that can improve     established and emerging cardiovascular risk factors, such as postprandial lipid and glycemic     responses, and vascular health. Postprandial derangements may affect multiple metabolic     pathways that lead to increased arterial stiffness. Research has demonstrated the potential     of strawberries to ameliorate postprandial responses to a high fat/high glucose meal. Further     research is needed to demonstrate this effect in better controlled clinical studies and     explore whether metabolic effects lead to improved arterial health.      The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry     powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including     lipids, insulin, glucose, and arterial stiffness and central blood pressure. The     investigators hypothesize that the bioactive components of strawberry powder will attenuate     postprandial lipemic and glycemic responses, as well as improve measures of arterial health.   "
99054|NCT01989624|"     Few data are currently available in the literature on pancreatic adenocarcinoma in France.     About 8,000 new cases each year in France. The 5-year survival for all stages combined is     <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.      Epidemiological characteristics at diagnosis, the impact on the survival of recent advances     related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy     (FOLFIRINOX) are mispriced in real life.      The development of new drugs and the development of Phase II and III require a better     understanding of the state of this disease in the country.      The main objective is to describe the characteristics of the pancreatic adenocarcinoma at     diagnosis in France and make an inventory of diagnostic practices and support.   "
99055|NCT01989611|"     A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the     acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine /     tenofovir disoproxil fumarate (FTC / TDF) administered orally, once daily, to MSM and     transgender women . The demonstration project aims to include 400 participants over 12     months, with 200 at IPEC-Fiocruz, 100 at CRT-SP and 100 at USP.   "
99056|NCT01989598|"     This phase II trial studies how well trametinib and Akt inhibitor GSK2141795 work in treating     patients with multiple myeloma that has come back (relapsed) or that does not respond to     treatment (refractory). Trametinib and Akt inhibitor GSK2141795 may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth.   "
99057|NCT01989585|"     This partially randomized phase I/II trial studies the side effects and best dose of     dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients     with v-raf murine sarcoma viral oncogene homolog B (BRAF) mutant melanoma or solid tumors     that have spread to other parts of the body or cannot be removed by surgery. Dabrafenib,     trametinib, and navitoclax may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
99058|NCT01989572|"     This randomized phase III trial studies sargramostim (Granulocyte-macrophage     colony-stimulating factor, GM-CSF) or vaccine therapy alone to see how well they work     compared to sargramostim and vaccine therapy together in preventing disease recurrence in     patients with locally advanced or stage IV melanoma that has been removed by surgery.     Sargramostim may stimulate the immune system in different ways and stop tumor cells from     growing. Vaccines made from peptides may help the body build an effective immune response to     kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy     are more effective alone or together in preventing recurrence of melanoma.   "
99059|NCT01989559|"     This pilot clinical trial studies booster vaccination in preventing disease recurrence in     previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made     from peptides may help the body build an effective immune response to kill tumor cells.     Giving booster vaccinations may make a stronger immune response and prevent or delay the     recurrence of cancer.   "
99060|NCT01989546|"     Background:        -  The poly (ADP-ribose) polymerase (PARP) family of enzymes is critical for maintaining          genomic stability by regulating a variety of DNA damage repair mechanisms.        -  BMN 673 is a PARP inhibitor with greater in vitro activity than any other PARP inhibitor          currently in development. BMN 673 has been shown to cause single-agent synthetic          lethality in BRCA1/2- and PTEN-deficient cell lines, and has potent antitumor activity          in animal models of tumors harboring mutations in DNA repair pathways.        -  BMN 673 is showing promising single-agent activity in patients with advanced ovarian and          breast cancer harboring deleterious BRCA mutations.        -  This pilot study will evaluate the pharmacodynamic effects of BMN 673 on DNA damage and          apoptosis markers in tumor biopsy tissue.      Primary Objective:      -Determine the pharmacodynamic effect of BMN 673 in tumor biopsies from patients with     advanced ovarian, breast, or other solid tumor and deleterious BRCA mutations.      Secondary Objectives:        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with          advanced ovarian or primary peritoneal carcinoma and deleterious BRCA mutations.        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with          advanced breast carcinoma and deleterious BRCA mutations.        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with          advanced solid tumor (other than breast or ovarian) and deleterious BRCA mutations.      Eligibility:        -  Adult patients with documented deleterious BRCA 1 or 2 mutations with histologically          confirmed ovarian, primary peritoneal, breast, prostate, pancreas, gastric or other          solid tumor whose disease has progressed following at least one standard therapy or who          have no acceptable standard treatment options.        -  No major surgery, radiation, or chemotherapy within 4 weeks prior to study enrollment,          and recovered from toxicities of prior therapies to at least eligibility levels.        -  Age greater than or equal to 18 years of age; ECOG performance status less than equal to          2        -  Adequate organ function.        -  Willingness to undergo tumor biopsies.      Study Design:        -  BMN 673 will be administered orally each day in 28-day cycles.        -  Dosing will be at the established recommended Phase II dose of 1000 mcg/day each day for           28 days.        -  We plan to accrue a total of 12 evaluable patients per cohort for a total of 36          patients. To allow for some patients who will not be evaluable, the accrual ceiling is          42 patients.        -  Tumor biopsies will be mandatory at baseline (pre-dose), and then approximately 3-6          hours post BMN 673 on day 8. An optional tumor biopsy may also be collected at time of          disease progression.      SCHEMA        -  BMN 673 is administered orally each day in 28-day cycles        -  Tumor biopsies will be performed at baseline (pre-treatment) and 3-6 hrs post dose on          cycle 1 day 8. An optional tumor biopsy may also be collected at time of disease          progression. Tumor biopsies will be evaluated for PAR levels, DNA damage response          markers such as >=H2AX, cleaved caspase 3, ERCC1, pNbs1, XPF, RAD51, and pT1989ATR, and,          as indicators of ATR/ATM activation, chk1 and chk2        -  Blood samples for CTC analyses will be collected at baseline (pre-treatment), on cycle 1          day 1(3-6 hours post dose), on cycle 1 day 8 (3-6 hours post dose), and on cycle 2 day 1          (3-6 hours post dose)        -  Blood samples for PK analysis will be collected on cycle 1 day 1 pre-dose and 0.5, 1, 2,          3, 4, 6,8, and 24 hours post-dose, on cycle 1 day 8 (3-6 hours post dose), and on cycle          2 day 1 predose and 3-6 hours post dose.   "
99061|NCT01989533|"     Background:      - Vaccines create resistance to disease. This study tests experimental human immunodeficiency     virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines     stimulate an immune response against HIV. This means the body works to fight infection.     Researchers want to see if different ways of giving the vaccines cause different immune     responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause     cold symptoms or mild eye infections.      Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their     entire household and intimate contacts must participate.      Objective:      - To test the safety of experimental HIV vaccines.      Eligibility:      - Healthy adults 18-49 years old.      Design:        -  Participants will be screened with medical history, physical exam, and blood and urine          tests.        -  Participants will receive the vaccine 3 times over 6 months. Each time, they will have a          physical exam and blood and urine tests. Samples will be taken from their nose, rectum,          and cervix.        -  Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic          staff will observe them for 1 hour.        -  Some participants will receive the vaccine swabbed in their throat. They will get dose 1          at the hospital and stay there for 1 week. They will have medical tests and nose swabs.          Doses 2 and 3 will not require a hospital stay.        -  Participants will have 7 follow-up visits over 6 months, with a physical exam and blood          tests. Samples will be taken from their nose, throat, and rectum.        -  Household and intimate contacts will have 4 clinic visits over 8 months, with a physical          exam and blood tests.   "
99062|NCT01989520|"     Study to investigate relative bioavailability of up to five different formulations of AZD5069   "
99076|NCT01989312|"     The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial     plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block     alone.      Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular     only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S     will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of     lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve     blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and     motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5     minutes starting at the 10th minutes. The imaging, needling and performance times will be     recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic     time will be noted.   "
99063|NCT01989507|"     The purpose of this study is to determine the efficacy, acceptability and unintended     consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past     year substance use disorders (SUD). The primary aim of this study is to determine whether 6     weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more     smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of     toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of     substance use and substance cravings (drugs and alcohol) because this is relevant to the     safety of these products among smokers with SUD. Secondary aims are to study effects on     cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random     assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender,     degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided     with smoking counseling. Assessments over 6 months will assess effects both during the 6     weeks of using research cigarettes and after return to usual cigarettes. The importance is in     determining the viability and safety of this public health strategy in terms of effects on     both smoking and other substance use in a highly addicted population, which is essential to     determine before the FDA implements this policy.   "
99064|NCT01989494|"     This study will measure and compare the physical activity of the anesthesiologists during     routine daily work in the operating room as determined by the pedometer-counted steps and to     estimate the average daily physical activity by using a seven day exercise recall survey.   "
99065|NCT01989481|"     The purpose of this observational study is to investigate the preoperative and operative     factor of pain and functional outcome at one years following total knee arthroplasty and     spinal surgeon.   "
99066|NCT01989468|"     The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,     as well as up to 3-year efficacy, safety and tolerability data in subjects with active     Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),     disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis     factor alpha (TNFα) therapy.   "
99067|NCT01989455|"     Single center, randomized, double-blind, placebo-controlled, adaptive sequential     ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of     single doses of deferiprone administered by intravenous infusion to healthy males and     females. A bioavailability comparison will be included.   "
99068|NCT01989442|"     The study aims to investigate efficacy and safety of nasal mask and prongs used in     non-invasive ventilation in newborns by using esophageal pressure transducer.      The parameters including ventilation duration, hospitalization duration, pulmonary outcomes     and side effects will be evaluated.   "
99069|NCT01989429|"     M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of     plaque psoriasis and is being developed as a topical ointment formulation (M518101)      Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque     psoriasis.      Based on the results of previous phase II trials the phase III trial has been designed to     evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger     population of patients with stable plaque psoriasis.   "
99070|NCT01989416|"     The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing     of colonization of multi-drug resistant bacteria in intensive care unit patients.   "
99071|NCT01989403|"     The investigators report management of lumbar disc herniation with severe sciatic pain using     an integrative complementary and alternative medicine approach with a 5 year follow-up.   "
99072|NCT01989364|"     Background: The Apparent Diffusion Coefficient (ADC) acquired by Diffusion Weighted Imaging     (DWI-MR) has been shown to correlate with cellular density. The ADC is indicative of Gross     Tumour Volume (GTV), and preliminary data shows that the dynamics of DWI volumes during     treatment (shrinkage) as well as dose to DWI volumes has impact on treatment outcome.      Hypoxic tumour cells within the primary tumour have been identified to have prognostic     importance for local control Tumour hypoxia is caused by insufficiency of the tumour     vasculature leading to both chronic diffusion limited and acute flow limited hypoxia.     Radioresistant hypoxic cells diminish the rate of local control, and the hypoxia driven     increase in metastatic potential of the tumour and lowers the rate of distant disease     control. Functional imaging has the potential to visualise radioresistant tumour subvolumes.     PET scanning (18F-FAZA) is hypothesized to visualise hypoxic tumour subvolumes, and dynamic     contrast enhanced (DCE) MR imaging has been used to quantify the extent of poor perfusion     regions within cervical tumours.      Objectives:      Primary:      Sensitivity and specificity of functional imaging (18F-FAZA PET (optional), T1w, T2w, DWI-MRI     and DCE-MRI) to identify tumours with good and bad response to radio-chemotherapy      Secondary:      Determining whether there are differences in bias between centre. The difference in bias will     be assessed for the T1 and T2 scans and the Ktrans and ADC maps.   "
99073|NCT01989351|"     The study purpose is to examine polymorphism of genes associated to post-operative persistent     pain and to verify the possible association between genotype phenotype and ADRB2 polymorphism     in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2 in VAS>4     patients and to compare it to those with VAS<4.   "
99074|NCT01989338|"     To investigate relationship between HV deformity and position of rearfoot joints, and its     effects on the quality of life, pain, and related functional status in women with bilateral     hallux valgus (HV).   "
99075|NCT01989325|"     This is a Phase 2 study during which patients with advanced multiple myeloma will receive     either carfilzomib alone (single-agent) or carfilzomib in combination with investigational     study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of     both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will     be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease     progression occurs. Approximately 75 patients from the US will be enrolled in this study.   "
99077|NCT01989299|"     Heart failure with preserved ejection fraction (HFPEF) is a large medical problem, for which     no drug or device has a recommendation in current heart failure guidelines. Sudden cardiac     death is suggested as the most common cause of death in HFPEF patients, although data is     sparse. Use of an Implantable Loop Recorder (ILR) may be useful in patients with HFPEF to     evaluate the incidence of sustained ventricular tachyarrhythmias. If ventricular     tachyarrhythmias are seem frequently, treatment with an Implantable Cardioverter     Defibrillator (ICD) may be an option in the future.   "
99079|NCT01989273|"     This is a study of patients admitted with major traumatic injuries. Such patients may develop     inadequate circulation to the organs as a result of internal blood loss. Early detection of     internal blood loss can be difficult as physical examination alone may miss patients with     significant blood loss. Some patients with internal bleeding will arrive with low blood     pressure; these patients are usually given 2 liters of intravenous fluid to determine if     their blood pressure will recover. If the blood pressure does not rise or if it drops again     later, the blood loss can be assumed to be severe, and the patient will likely need     transfusions, surgery and other interventions. However, this fluid treatment method can lead     to delays and complications as some patients may initially respond but then continue to     bleed. The inferior vena cava (IVC) is the large vein draining blood from the lower body to     the heart. The inferior vena cava is known to empty when the patient has had significant     blood loss. The vena cava diameter can be seen using ultrasound. This study intends to     perform ultrasound to examine the vena cava diameter on patients just after arriving with     major trauma. The hypothesis of the proposed study is that an ultrasound assessment protocol     of inferior vena cava diameter and collapsibility can detect and aid management of     non-compressible hemorrhage in major trauma victims. After the patient has been given the 2     liter intravenous fluid treatment, the inferior vena cava diameter will be measured again. A     third examination 8-24 hours after admission will determine if the inferior vena cava     diameter has returned to normal. We propose that measuring the inferior vena cava in this     manner can predict those patients who are likely to continue bleeding and require     interventions such as surgery. Early detection in these patients may avoid delays in     treatment, complications and excess mortality. Because this examination is done with handheld     ultrasound machines, it could be done outside hospitals and in military combat casualty care.   "
99080|NCT01989260|"     Endometriosis is a common gynaecological condition which typically present with pelvic pain     and fertility problems. It is caused by tissues which are similar to the lining of the womb     growing inside the women's pelvis. Severe endometriosis is most effectively treated using     keyhole surgery. During the operation, endometriosis tissue is removed. However, following     successful removal of endometriosis, women may still experience pain because the ovaries     sometimes become stuck to the bottom of the pelvis due to post-operative scarring. We want to     see if coating one of the ovaries in an anti-scar tissue gel stops the post-operative     scarring.   "
99081|NCT01989247|"     The purpose of this study is to investigate whether citizens experiencing symptoms of anxiety     and depression will benefit from a self-management training program with respect to: 1)     Self-efficacy, and 2) Symptoms of anxiety and depression, and 3) Self reported measures of     Health Related Quality of Life (HRQoL)   "
99082|NCT01989234|"     This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811     capsules in patients with chronic idiopathic constipation. Following a 2-week baseline     period, approximately 320 eligible patients with <3 complete spontaneous bowel movements     (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the     following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a     2 week follow-up period.      The objectives of this study are:        -  To assess the efficacy of YKP10811 once daily at relieving constipation and associated          symptoms in subjects with chronic idiopathic constipation.        -  To determine the safety and tolerability of YKP10811 once daily in subjects with chronic          idiopathic constipation.   "
99083|NCT01989221|"     The aim of this study is to determine the efficacy of Sancuso® (granisetron transdermal     system) 3.1 mg/24 hours in improving symptoms of nausea and vomiting in patients with     gastroparesis. This will be a prospective open-label study using Sancuso® to treat symptoms     of nausea and/or vomiting in patients diagnosed with gastroparesis. Symptomatic patients with     diabetic or idiopathic gastroparesis with nausea and/or vomiting will be enrolled. The     Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) will be used to capture the     severity of symptoms, including nausea and vomiting, at baseline for one week. Patients will     then be treated with Sancuso®. Patients will continue to fill out the GCSI-DD on a daily     basis while undergoing treatment with Sancuso® for two weeks. To determine if Sancuso®     treatment helps improve symptoms of nausea and vomiting, the symptoms at baseline will be     compared to symptoms after the first week and the second week of treatment. Thirty patients     diagnosed with gastroparesis (approximately 15 with diabetic and 15 with idiopathic     gastroparesis) will be treated on an open label basis with Sancuso®. The goal of this study     is to demonstrate the efficacy of Sancuso® in treating nausea and/or vomiting in     gastroparesis patients. Safety information will also be collected regarding any adverse     effects. If the results are encouraging, as we expect them to be based on personal     experience, a larger double blind study would be appropriate.   "
99084|NCT01989208|"     Patients with heart failure are reported to have lower levels of hydrogen sulfide in their     blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule     that has been shown to have a number of beneficial effects and thus the low levels may     contribute to the disease. This trial is testing whether a medical food product of synthetic     sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.   "
99085|NCT01989195|"     The investigator hopes to introduce a novel MRI contrast agent with SeeMore ™ that directly     defines viable myocardium. Identifying viable myocardium non-invasively using cardiac MRI is     still a moving target and a question we plan to answer more definitively with the SeeMore ™     contrast. Though well tested in small and large animals and Phase I & II clinical trials, the     investigators would like to determine the efficacy of the SeeMore contrast further in a     clinical setting.      SeeMore is a new manganese (Mn)-based intravenous imaging agent being developed to enhance     magnetic resonance imaging (MRI). While Mn has long been known to have desirable magnetic and     kinetic properties for MRI, use in humans was not initially possible due to cardiovascular     depression and electrocardiogram (ECG) changes, including prolongation of PR and QTc     intervals, associated with intravenous administration [1-5]. SeeMore provides Mn in a form     that maintains the desired magnetic and kinetic properties while overcoming the     cardiovascular toxicity of Mn. SeeMore is taken up into heart cells (primarily via addition     of calcium to avoid cardiotoxic effects; please refer to US patent #5,980,863). The potential     to distinguish healthy heart tissue from unhealthy heart tissue based on a specific sustained     pattern of enhancement provides a basis for evaluating the performance of SeeMore in heart     patients. It may be possible to enhance the utility of MRI for heart disease through the use     of an imaging agent that is specifically taken up into heart cells. SeeMore is the only     cardiac-specific agent being developed for this purpose. Unlike nuclear perfusion agents,     SeeMore is not radioactive and does not require special handling, shielding, transport or     storage. In addition, the specific pattern of enhancement achieved in the heart muscle     persists over time, offering potential benefits over the nonspecific extracellular agents     currently available for MRI or X-ray/CT procedures. This feature allows full use of the high     resolution of MRI, since there is not a trade-off of high spatial resolution for temporal     (first-pass) resolution. It is anticipated the features offered by SeeMore along with the     high resolution, three dimensional attributes of MRI will result in higher accuracy than is     available with other current modalities in practice, including stress echocardiograms,     cardiac MRI using gadolinium contrast and nuclear studies such as SPECT and PET. This will be     evaluated in this study and serve as the basis for pivotal registration studies.      All components of SeeMore™ are USP and are approved for use as drugs in man, orally and/or     intravenously.   "
99120|NCT01988740|"     The finding that ischemia-modified albumin (IMA) is increased in pre-eclamptic pregnancy     suggests a role for IMA as a potential biomarker for abnormal placental development related     to miscarriage.This study was undertaken to evaluate IMA levels in women with recurrent     pregnancy loss (RPL).   "
99754|NCT01980420|"     Improved results for sleeve gastrectomy could be possible if more was known about the     surgical / mechanical factors that affect outcome.   "
99093|NCT01989091|"     Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain catheter     patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in dialysis     patients using a central venous catheter (CVC) for vascular access.      The study is a prospective, randomized, site unblinded/sponsor blinded, clinical study of a     minimum of 300 dialysis patients using a central venous catheter (CVC) for vascular access.     Patients will be randomized 1:1 to receive either the investigational medical device (B-Lock     or IMD) or active control heparin (5000 U/mL) (ACH) and observed for a minimum of 45 days or     a maximum of 273 (expected average 160 days). IMD or ACH will be instilled into the catheter     lumens (dual lumen catheters) at the end of each dialysis session and removed prior to the     initiation of the next dialysis session.      The primary objectives of this study are:        -  To demonstrate the safety of B-Lock in dialysis patients        -  To demonstrate the non-inferiority or, if proven to be non-inferior, superiority of          B-Lock relative to ACH with respect to maintaining catheter patency as defined by the          use of recombinant tissue plasminogen activator for maintaining adequate blood flow          through the dialysis catheter        -  To demonstrate the superiority of B-Lock relative to ACH with respect to the incidence          of CLABSI   "
99094|NCT01989078|"     Sickle cell nephropathy (SCN) is a progressive complication of sickle cell disease (SCD) that     begins in childhood and results in renal (kidney) failure and early mortality in nearly 12%     of adults with hemoglobin SS (HbSS). The potential for prevention and reversal of kidney     damage in SCD is not known. Albuminuria is a commonly used biomarker of glomerular damage;     however the correlations of albuminuria with specific measurements of glomerular function and     pathophysiology have not been determined. The investigators hypothesize that in patients with     persistent albuminuria despite treatment of SCD with hydroxyurea, losartan will reverse     kidney dysfunction in early stage nephropathy and ameliorate progressive kidney dysfunction     in more advanced nephropathy. The primary aim is to study the acute and longer-term effects     of losartan (study drug) on specific glomerular functions in children and adults with SCD who     have persistent albuminuria. Research glomerular function tests will be done at study entry     (prior to taking losartan), 1 month, and 1 to 2 years after starting losartan therapy     (participants may take losartan for up to 24 months). In addition, participants are seen each     month in clinic and assessed by their regular clinical team. The second aim is to assess the     correlation of changes in albuminuria after 1 month of losartan with changes in direct     measurements of glomerular function at 12-24 months, thus determining if the magnitude of the     initial decrease in albuminuria in response to losartan predicts sustained improvements in     renal function.   "
99095|NCT01989065|"     Outpatient childhood obesity treatment has limited efficacy. This study aims to improve the     health habits of parents of obese 5-12 year old children enrolled in the Duke Healthy     Lifestyles Program by delivering educational and supportive text messages to the parent's     mobile device.   "
99096|NCT01989052|"     This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent     malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at     Duke. The Primary Objectives are:        -  Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with          lomustine among patients with recurrent malignant glioma (World Health Organization          (WHO) grade III or IV) who have not been previously treated with bevacizumab.        -  Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with          lomustine) compared to lomustine alone in patients with recurrent WHO grade IV malignant          gliomas that have not been previously treated with bevacizumab based upon 6-month          progression free survival (PFS6).      Note: This study was terminated early due to funding issues. At the time of termination, the     study was still in Phase 1 and no MTD for the combination of CTO and lomustine had been     determined for this population. Phase 2 will not proceed.   "
99372|NCT01985425|"     The purpose of this pilot study is to determine the feasibility of comparing colchicine to     placebo for the prevention of new onset atrial fibrillation in patients undergoing general     thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.   "
99097|NCT01989039|"     FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or     central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade     chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS.     However, obesity is also associated with increased inflammatory markers. Obesity is per se     associated with increased adipose expression and plasma levels of leptin, lower expression of     adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory     markers and cardiovascular risk in women with PCOS, body weight status should be considered.     Investigator therefore conduct this retrospective study to evaluate the insulin     resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and     non-obese women.   "
99098|NCT01989026|"     Recent studies show that BCG vaccination reduces neonatal mortality by more than 40%. This     effect cannot be explained by prevention of tuberculosis, which is very rare among infants.     The protective effect of BCG vaccination is seen already within the first week. It seems that     BCG provides a non-specific beneficial immune modulation - thereby reducing overall     mortality. Mortality is very high among newborns admitted to the neonatal intensive care     unit. If BCG has immediate beneficial effects on the immune system, vaccinating children with     BCG as early as possible may save lives. The investigators will test this hypothesis in a     randomized trial among newborns in Guinea-Bissau, randomizing newborns admitted to the     neonatal intensive care unit at the National Hospital 1:1 to BCG immediately or at discharge     (usual practice).   "
99099|NCT01989013|"     We are studying & researching the effect of CranioSacral Integrative therapy on Parkinson's     Diseased Patients for 3 months. With a therapeutic induction via manual CranioSacral     integrative therapy for 90 minutes per session with a total of 2 session divided equally in a     month (biweekly intervention). At the end of 3 months each patient will have total of 9 hours     of CranioSacral Integrative therapy induced, we will document the symptoms and shortcomings     of the patients at evaluation, before and after therapeutic treatment on a measured scale     ranging from 1-10. Finally graphically and statistically measure the quality of change in the     symptoms at the end of 3 months and provide executive summary of the research finding, which     the investigators expect to be a positive one.   "
99100|NCT01989000|"     Pancreatic cancer is a highly lethal disease. Patients with resectable or borderline     resectable disease may benefit from preoperative radiochemotherapy. However, only a subset of     patients will respond to this potentially toxic and expensive treatment. Therefore, novel     predictive markers are needed to determine treatment efficacy at an early stage. Preferably,     these markers could be determined non-invasively and provide insight into the biology of     pancreatic cancer. Pancreatic cancers are heterogeneous tumors. The tumor microenvironment is     often characterized by large amounts of stroma, hypovascularization, and hypoxia. As these     three factors can all contribute to treatment resistance, a quantitative assessment of these     markers may aid in the prediction of response to preoperative radiochemotherapy. Moreover,     these assessments may have prognostic value. Finally, further insight into the interrelation     of these aspects of the tumor microenvironment can contribute to the evaluation of new     targeted treatment options. Tumor cellularity and extracellular matrix composition can be     assessed non-invasively in vivo by diffusion weighted magnetic resonance imaging (DWI) and     tumor vascularity can be assessed by dynamic contrast enhanced magnetic resonance imaging     (DCE-MRI). Finally, tumor hypoxia can be evaluated by T2* MRI and PET-CT, using the     18F-labeled hypoxic marker HX4.      Objective of the study:      The primary aim of the study is to assess whether DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT     predict overall survival in patients with pancreatic cancer treated with surgery and adjuvant     chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy.     Secondary aims of the study include the assessment of the predictive value of DWI, DCE-MRI,     T2*, and 18F-HX4-PET/CT for pathological response to neoadjuvant chemoradiation, the     correlation of DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT with histopathological assessment of     tumor stroma, vascularization, and hypoxia, and the assessment of the predictive value of     these histopathological markers for overall survival.   "
99101|NCT01988987|"     Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated     with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to     30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after     delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is     essential because serious health problems can result.      Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks     after delivery for women diagnosed with GDM in order to identify those with continued DM or     impaired glucose metabolism. However, approximately half of these women do not get glucose     testing after delivery. The ability to test women while they are still hospitalized after     having a baby could greatly increase diagnosis, care and treatment of women with abnormal     glucose metabolism.      Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to     four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks after     delivery.   "
99102|NCT01988974|"     The purpose of this study is to determine the psychometric properties of the Knowledge,     Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS) and to generate critical,     practical knowledge about the feasibility of conducting a randomized trial to test the effect     of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of Atrial     Fibrillation (AF).   "
99103|NCT01988961|"     The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set     panel (a genetic test) in predicting response to golimumab treatment in participants with     moderately to severely active ulcerative colitis (UC).   "
99104|NCT01988948|"     Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The     high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The     introduction of vaccination against two major oncogenic genotypes of HPV raises questions     about genotype replacement because of the existence of other oncogenic types not targeted by     the vaccine. A better understanding of natural history of HPV infection and interaction     (competition, synergy) between genotypes are required in order to anticipate this phenomenon.      The aims of this study are to characterize HPV infection in young female students and to     follow up HPV infection and co-infection dynamics with different genotypes, taking into     account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the     determination of factors influencing the development of persistent cervical HPV infections.      The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from 18     to 20 years-old, all registered at the Universities of Bordeaux or Versailles Saint-Quentin     (UVSQ). The 3-years follow-up includes completion of a self-administrated questionnaire     regarding sexual behaviour, socio-demographic characteristics, access to health-care services     and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for     the detection and genotyping of HPV (every 3 months). Previously, a pilot phase study (2     visits in 3 months of interval) is set up on 50 young female students from UVSQ in order to     test feasibility.      This study will provide data to gain insight into the possibility of type replacement.     Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV     incidence and factors associated with HPV infection and co-infection ; Partners recruitment     would allow us to follow HPV transmission dynamics among couples, and in particular, HPV     exposure in young adult women. The HPV research won't be limited to virus detection in     samples but will indicate the presence or absence of HPV infection.      Finally, additional genetic studies could be conducted in order to study genetic     susceptibility to HPV infection, to chronic HPV infection and to co-infection.      This research project is part of the i-Share program funded by the Investissement d'Avenir     cohort call.   "
99440|NCT01984541|"     The objective of this study is to determine the biological activity of Artemisia vulgaris     allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house     reference preparation (IHRP).   "
99105|NCT01988935|"     Research shows that people with PTSD are more likely to smoke than people without PTSD. It     also shows that people with PTSD have more difficulty at attempts to quit smoking. This study     is part of a program aimed at finding out how best to help smokers quit who also have PTSD.     One option is to give patients standard smoking cessation treatment including nicotine     replacement and cognitive behavioral therapy. Another option is to give patients the standard     smoking cessation treatment in addition to treatment for their PTSD symptoms (called     prolonged exposure). However, it is not known which method works better. In order to answer     this question, patients will be assigned by chance to one of two groups. One group will be     given standard smoking cessation treatment to help quit smoking. A second group will be given     the standard smoking cessation intervention to help quit smoking in addition to a form of     psychotherapy called Prolonged Exposure to reduce symptoms of PTSD. The patients will be     randomly assigned (by chance) to one of these groups. If the patient is assigned to the     smoking cessation only condition and the patient still has PTSD symptoms after the last study     visit (week 30) the patient will be offered treatment for your PTSD symptoms (Prolonged     Exposure) at no cost. The patient's participation will help the investigators determine if     treating PTSD symptoms enhances the ability of standard smoking cessation to help people quit     smoking.   "
99106|NCT01988922|"     This research study will determine if genetic variation in CYP2B6 affects how the body     metabolizes ketamine.   "
99107|NCT01988909|"     The objectives of the study are to evaluate the safety and efficacy of open label treatment     with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated,     non-severe cutaneous leishmaniasis (CL).   "
99108|NCT01988896|"     This is a Phase Ib, open-label, multicenter study designed to assess the safety,     tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of     atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral     dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no     standard therapy exists.   "
99303|NCT01986322|"     The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib     (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.   "
99110|NCT01988870|"     The purpose of this study is to evaluate an investigational way to provide radiation therapy     to treat breast cancer at the time of surgery.      Traditionally, the recommended treatment for early stage breast cancer is surgery to remove     the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of     the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can     be associated with damage to other tissues including the skin. Recent technological advances     have made it possible to provide radiation treatment during the breast cancer surgical     procedure. This procedure is called intraoperative radiation therapy (IORT). The University     of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging     technology into the IORT procedure in order to provide delivery of radiation directly to the     needed areas and to avoid radiation to other tissues.   "
99111|NCT01988857|"     This study will evaluate the safety and reactogenicity of GSK Biologicals' combined     reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when     given as a single injection to 6-10 year old children. Data that are available globally on     the age group from four to six years of age will be used to bridge the age gap in this study     and aid in the registration of the vaccine for children from the age of four years.   "
99112|NCT01988844|"     Cerebral palsy is the leading cause of physical disability among children. Manual dexterity     and upper limbs functionality is limited between these children. The purpose of this study is     to stablish a specific profile of school children with cerebral palsy based on the upper     limbs assessment.   "
99113|NCT01988831|"     Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to     an earlier detection of the primary tumour and a better prognosis, but melanoma remains an     aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies     compared groups of patients diagnosed with primary melanoma and treated with betablockers for     another indication to patients who never received betablockers. In these three studies, the     outcome of the disease is significantly better for people under betablocker treatment with a     decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate     the efficacy and the tolerability of an adjuvant treatment with propranolol for patients     suffering from a primary melanoma with a high risk of recurrence.   "
99114|NCT01988818|"     The primary objective of this investigation is to evaluate the performance of a self-adhesive     absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of     the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in     comparison to a standard wound dressing The secondary objectives are to evaluate:        -  the performance of the dressing        -  the comfort, conformability and the acceptability of the dressing        -  pain before, during and after dressing removal        -  the overall cost regarding dressing wear time, time to do dressing change and personal          resources needed   "
99115|NCT01988805|"     This study is intended to collect blood from healthy individuals to investigate whether     variations in immune-related (inflammasome) genes affect how the immune cells found in the     blood can help fight infections and prevent diseases.   "
99116|NCT01988792|"     The purpose of this study to find out how safely we can add extra nutrients to human milk at     different feeding volume.   "
99117|NCT01988779|"     The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis     (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms     and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral     antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily     intranasal antibiotic irrigations. The two treatments will be compared to see if there is any     difference in patient outcomes. This will help guide treatment strategies for patients with     CRS in the future.   "
99441|NCT01984528|"     The objetive of this study is to determine the minimum amount of Alternaria alternata     allergen extract producing in a positive skin reaction.   "
99121|NCT01988714|"     The purpose of this study is to investigate the usefulness of neuroscience-guided cognitive     training combined with community-based supported employment for people with schizophrenia.     The investigators will examine the effectiveness of moving our study of neuroplasticity-based     restorative targeted cognitive training out of the laboratory and into the community setting;     and the investigators will also investigate its utility in enhancing functional outcome in     chronically mentally ill adults who are participating in supported employment.   "
99122|NCT01988701|"     This research trial studies lymphocyte profiles and activation status in patients with     graft-versus-host disease. Studying samples of blood in the laboratory from patients with     cancer may help doctors identify and learn more about biomarkers related to graft-versus-host     disease.   "
99123|NCT01988688|"     This study will test the safety and effectiveness of deep brain stimulation (DBS) for     patients with a big or very big problem with tinnitus (a sensation of noise in the head).   "
99124|NCT01988675|"     This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early     changes in white matter (in the brain) and the blood-brain barrier resulting from radiation     therapy.   "
99125|NCT01988662|"     This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with     neovascular Age-related Macular Degeneration following treatment with Ranibizumab or     Aflibercept.      Free plasma VEGF-A level was measured in this study .   "
99135|NCT01988532|"     This study is conducted in the United States of America (USA). The aim of the study is to     assess the impact of pain on functional impairment and quality of life in adult persons with     hemophilia (PWH) with and without inhibitors with joint bleeding.   "
99212|NCT01987505|"     This open-label, single-arm, phase IIIb study will evaluate the safety of switching from     intravenous (IV) to subcutaneous (SC) administration of MabThera/Rituxan during first-line     treatment for patients with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large     B-cell lymphoma (DLBCL) who have already received at least one full dose of MabThera/Rituxan     IV. Patients with FL will be given 1400 mg MabThera/Rituxan SC during induction therapy (once     monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400     mg SC of MabThera/Rituxan will be given to patients with DLBCL once monthly for 4-7 cycles.     Treatment duration is expected to last up to 7 months for patients with DLBCL and up to 32     months for patients with FL.   "
99126|NCT01988649|"     Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In     addition,oxytocin have an important roles in sexual reproduction , in particular during and     after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin     has been commonly used to improve breastfeeding in lactating women. A review of safety , side     effects and subjective reaction to intranasal oxytocin in human research in 1529 subjects did     not review any differences from placebo. The vast majority of basic science studies suggested     a large effect of oxytocin in minimizing acute pain.4 Few studies have demonstrated an     association between plasma levels of oxytocin and pain in humans. No studies have examined     the effect of intranasal oxytocin on pain sensitivity and threshold. Since addictive     properties of oxytocin have not been described, the drug may have important application in     the management of acute and chronic pain.      The main objective of the current investigation was to evaluate the effect of intranasal     oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that     intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain     threshold compared to intranasal saline .      Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain in     humans.   "
99127|NCT01988636|"     Background:      - Malaria is caused by small germs carried by mosquitoes. People can get malaria if an     infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the     blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year.     About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to     find a safe vaccine that helps prevent malaria.      Objectives:      - To see if a new malaria vaccine is well tolerated and effective.      Eligibility:      - Healthy adults 18 35 years old who are not pregnant and live in Mali.      Design:        -  Participants will be screened with medical history, physical exam, and blood test. They          will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record          the heart s electrical signals.        -  Study participation will last about 1 year.        -  Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ          vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses          of placebo.        -  Doses will be given through a needle in the arm directly into the bloodstream. Then          participants must stay at the clinic for 2 hours.        -  After each dose, participants will return to the clinic several times for blood tests          and physical exam.        -  A week before the first dose and 2 weeks after the last, participants will take a full          course of anti-malaria drugs.        -  If a participant gets malaria during the study, they will take another course of          anti-malaria drugs.   "
99128|NCT01988623|"     The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the     treatment of communication deficits in children with intellectual disabilities. By collecting     information about parent and child functioning before and after PRT, The investigators will     be able to determine whether the intervention is effective in improving child communication     and reducing parent stress.   "
99129|NCT01988610|"     The purpose of this study is to study the effect of cortisol,a stress hormone in the body, on     memory and attention in people with a history of depression, but who are not in the midst of     a current depressive episode.      Cortisol may affect parts of the brain associated with memory and attention directly. It may     also indirectly affect the brain by controlling how much insulin the body makes. Insulin is     thought to impact cognition by changing the amount of sugar available in certain parts of the     brain.      The investigators are studying this question by giving patients a medication, called     Mifepristone, which reduces cortisol's effect on the brain. The investigators will compare     results from several groups of people, including differences between men and women, and     between those with and without insulin resistance.   "
99130|NCT01988597|"     Dry eye syndrome is a very common condition with multiple etiologies that includes systemic     and ocular disease that causes reduction in the production of tears, as well as increase in     tears evaporation. As a result of the various etiologies and large variability of dry eye's     clinical sign, it has been a challenge for practitioners to have a consistent system to     classify dry eyes and to have an appropriate and accurate measurement to quantify the     severity of dry eyes and its impact on patients' quality of life.6 To date, no study which     evaluates the extent of questionnaires correlates with changes in quality of life. With this     cross sectional interview study, we aim to determine the efficacy of the questionnaires as a     practical tool in our future clinical trials at our center.   "
99164|NCT01988155|"     The purpose of this research study is to determine if Astym® treatment is an effective     treatment for patients with Achilles pain. The usual treatment for this condition is a     specific exercise program that has been previously shown to be effective. The research team     is trying to determine if combining Astym with the exercise program is more effective than     exercise program only.      The main hypothesis for this study is that Astym plus eccentric exercise will be more     effective than eccentric exercise alone at improving pain and function in patients with     insertional Achilles tendinopathy.   "
99131|NCT01988584|"     The purpose of this study is to compare the safety and effectiveness of two types of stem     cells,(either banked cord blood or bone marrow), in children between the ages of 2 to 10     years with CP. 15 children with banked cord blood at CBR and 15 children without banked cord     blood will be enrolled into the study. The study involves one baseline/treatment visit and 3     follow-up visits at 6 months, 12 months, and 2 years. Five children in each group will be     randomized to a placebo control group at the baseline/treatment visit. Parents will not be     told if their child received stem cells or a placebo until the 12 month follow-up visit. At     that time parents may elect to have their child receive the stem cell treatment; either bone     morrow harvest or umbilical cord blood if banked with CBR. All study visits will be conducted     at the UTHealth Medical School and Children's Memorial Hermann Hospital in Houston, Texas.      As of 1/21/2014 we have met our enrollment limit for children without banked cord blood     undergoing bone marrow harvest for stem cells.   "
99132|NCT01988571|"     The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily     decreases the chance of developing heart problems in women receiving adjuvant     anthracycline-based chemotherapy for breast cancer.   "
99133|NCT01988558|"     The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and     preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.   "
99136|NCT01988519|"     Pancreatic resection is the only potentially curative modality of treatment for pancreatic     neoplasm. The mortality associated with this procedure decreased rapidly in the past decades.     However, the morbidity associated with pancreatic resection remains high. The main reason for     postoperative morbidity is postoperative pancreatic fistula (POPF), which is regarded as the     most ominous complication following pancreatic resection. Its reported incidence varies in     the surgical literature from 10% to >30%.      Recently published studies showed that the placement of intraoperative drains, manipulation     with the drains, timing of removal of the drain, and especially the type of drain, have     significant effect on the postoperative complications, and especially POPF.      Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two     most commonly used systems are closed suction drainage and closed gravity drainage. Open     systems have been abandoned in most centers as they are obsolete.      Our hypothesis is that the closed suction drain will have better results as it is more     effective than the gravity drainage. However, some surgeons claim that the suction system can     actively suck the pancreatic juice through the anastomosis or suture and thus promote the     development of POPF.      The aim of this study is to compare closed suction drains and closed gravity drains after     pancreatic resection in a randomized controlled study.      The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point     is the postoperative morbidity.   "
99137|NCT01988506|"     TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in     a set of 12 autoimmune and auto-inflammatory diseases, with the aim to select diseases in     which further therapeutic development will be performed. Extensive biological- and     immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct     processes responsible for the breakdown of immunological tolerance in these pathologies and     (ii) to discover potential biomarkers of the IL2 response.   "
99139|NCT01988480|"     The objective of this study is to compare two surgical procedure to place implant in severely     resorbed posterioir part of the maxilla.   "
99140|NCT01988467|"     The aim of this study was to compare the acute effects of second hand smoke exposure between     nasal and oral breathing and to assess the potential protective role of the nose during acute     exposure, in exposure conditions similar to those within a bar where smoking is permitted.   "
99141|NCT01988454|"     The primary objective of this pilot study is to characterize the profile of lipoprotein,     inflammatory, and metabolic markers of cardiovascular disease in obese adolescents as     compared to normal-weight age-matched controls.   "
99142|NCT01988441|"     Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver     disease worldwide. It is not known why only some obese subjects develop NAFLD. In recent     years, a growing body of evidence showed a crucial role of autophagy in in the regulation of     liver fat storage. The purpose of this study is to determine whether autophagy     pathway-related genetic polymorphisms affect NAFLD.   "
99150|NCT01988337|"     This is a three year single site clinical evaluation of a FDA approved (510(k):K100062)     lesion penetrating resin used to infiltrate and hamper progression of proximal carious     lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon,     Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The     study is designed as a randomized, controlled, prospective clinical trial with a three year     follow-up evaluation period.      The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2     study lesions. The patients will be evaluated at six time points over a period of 3 years.     Lesion status and caries risk will be monitored at 6-month intervals, while radiographic     evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.   "
99165|NCT01988142|"     After spinal cord injury (SCI), the muscular property altered due to the immobilization     adaptation. The purpose of this study was to investigate the effect of remobilization with     continuous passive exercise on the adapted paralyzed muscle properties after SCI.   "
99442|NCT01984515|"     The purpose of this study is to implement an evidence-based Referral Management System that     will address patient and system-level barriers to the uptake of evidence-based psychotherapy     for PTSD by Veterans Affairs primary care patients.   "
99907|NCT01978431|"     Examine the interaction between stimulants, such as cocaine and methylphenidate, and     impulsivity.   "
99143|NCT01988428|"     Sepsis is one of the most frequent reasons for referral to emergency departments (EDs)     worldwide. The incidence of sepsis is likely to rise in the upcoming years. Sepsis has a     tendency to become more serious when left untreated with a high mortality rate, exceeding     even those of myocardial infarction and stroke. Therefore, much effort has been put in to     start with appropriate therapy as early as possible. Early goal-directed therapy (EGDT) in     the emergency department with fluid resuscitation, administration of     vasopressors/vasodilators and intravenous antibiotics in patients with severe sepsis and     septic shock has indeed decreased mortality substantially. Emergency medical services (EMS)     personnel have already made a significant difference in improving care for patients with     acute coronary syndrome, multiple trauma and stroke. Patients with severe sepsis or septic     shock could also benefit greatly from timely pre-hospital care. Earlier recognition and     initiation of treatment by EMS personnel may improve survival even more.      Interestingly, the first hour of ED presentation seems to be the most critical hour.     Administration of antibiotics and fluid resuscitation in the pre-hospital setting will reduce     the time to administration substantially. In adults, to the best of our knowledge, no studies     on the effect of pre-hospital administration of antibiotics have been performed. In children     with meningitis, some uncontrolled studies show contradictory results, most probably due to     bias by severity. We propose a non-blinded randomised multicentre clinical trial study on the     efficacy of early, pre-hospital intravenous administration of broad spectrum antibiotics     (ceftriaxone), which are effective against a wide variety of infectious pathogens that cause     most common community-acquired infections) in patients referred to the ED with suspected     severe sepsis or septic shock.      Objective: To evaluate whether early, pre-hospital administration of antibiotics, together     with training of ambulance personnel in recognizing and initiating treatment reduces 28-day     mortality in patients referred to the ED with suspected severe sepsis or septic shock      Study design: Non-blinded randomized multicentre clinical trial nested within a stepped wedge     design      Study population: All patients above the age of 18 years, with suspected severe sepsis or     septic shock and transferred to the ED by ambulance, are eligible for study inclusion      Intervention: prehospital antibiotics (ceftriaxone 2000 mg intravenously)      Main study parameters/endpoints: 28-day mortality, hospital length of stay, admission to     intensive or medium care unit (ICU/MC), time to administration of antibiotics. Follow up of     one year. QoL after one month after discharge.   "
99144|NCT01988415|"     The purpose of this clinical trial is to demonstrate that treatments generated by an     investigational algorithm reduces spherical aberration compared to currently available     iDesign treatments.   "
99304|NCT01986309|"     There some evidence regarding the effect of lidocaine for the prevention of nausea and     vomiting in adults.   "
99305|NCT01986296|"     The goal of this prospective, non-randomized, single-arm, single site, feasibility study is     to develop and collect data to evaluate the safety and initial effectiveness of this     treatment using this ExAblate transcranial System in the treatment of Medication-Refractory     OCD.   "
99145|NCT01988402|"     Traditional teaching holds that starting allopurinol during an acute gout attack will prolong     the attack. Recent expert opinion from the American College of Rheumatology Guidelines is     that allopurinol may be started during an acute, treated gout attack. This study is designed     to test the hypothesis that allopurinol does not prolong an acute, treated gout attack.     Patients will either take allopurinol capsules or and identical capsule containing no     allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being     treated with other standard measures. During the study, neither the patient nor the examiner     will know what pills are being taken. The time to resolution of the attack is the primary     outcome measure. Pain level, serum uric acid level, and complications of therapy will also be     monitored. A minimum of 32 patients completing the study are needed for a meaningful     conclusion.   "
99146|NCT01988389|"     There is now considerable scientific evidence that a diet rich in fruits and vegetables could     improve human health. Apples are among the most frequently consumed fruits in the world.     Epidemiological studies have linked frequent apple consumption with several health benefits     including a reduced risk of cardiovascular disease. Apples are an important source of     polyphenols and fiber and their beneficial effects could be attributed to this content;     however, their impact on our health is not clear. Although, there are some studies that have     reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies     have explored the impact on vascular function and gut microbiota. The objective of the     current study is to assess whether a regular apple consumption, reduces total cholesterol     levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic     subjects compared with a control, sugar matched commercial clear apple juice squash.   "
99147|NCT01988376|"     Background/Purpose: This is a large scale, multicenter randomized clinical trial to assess     the feasibility of using SurePath® in cervical cancer patients after radiation therapy by     comparing the incidence of unsatisfactory smear and the accuracy of detecting cervicovaginal     lesions between the SurePath® and the conventional smear.      Patients and Methods: The investigators will invite all women who had received radiotherapy     for cervical cancer in the investigators outpatient clinics. All enrolled cases will ask to     receive randomly the SurePath® or the conventional smear.      Expected Results: The investigators will get the incidence of unsatisfactory smear and the     accuracy of detecting cervicovaginal lesions between the SurePath® and the conventional smear     in patients who underwent radiotherapy.   "
99148|NCT01988363|"     This study is designed to answer the question of whether injection of the greater occipital     nerve at its proximal origin, near the C2 vertebrae, using ultrasound guidance is effective     in improving pain in human subjects.      HYPOTHESES        1. Ultrasound (US) guided greater occipital nerve (GON) injections are effective at a          novel, proximal C2 location in live, human subjects, measured by improvement in visual          analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes          post-injection, 2-weeks post-injection, and 1-month post-injection .        2. Ultrasound (US) guided injection of the greater occipital nerve (GON) at a novel, C2          location is effective at improvement of both occipital neuralgia and cervicogenic          headache demonstrated by improvement in visual analog scale (VAS) pain scores          pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection,          and 1-month post-injection. We further hypothesize that the mean improvement in VAS          scores at 1-month post injection will be greater than 2 units.        3. Ultrasound (US) guided injection of the greater occipital nerve (GON) at novel, proximal          C2 location in live, human subjects appears safe.   "
99149|NCT01988350|"     Pancreatic insufficiency is a condition in which there is a decrease in the production and     release of enzymes made in the pancreas, which causes nutrient malabsorption. There are many     chronic diseases that can lead to pancreatic insufficiency. In the early stages of this     disease, a patient may not experience any symptoms, and the prevalence of pancreatic     insufficiency may be underestimated. Smoking has long been recognized as a cause of disease     in many organs in the body. Cigarette smoke causes inflammation and damages tissue, including     the pancreas. Studies have shown that smoking is an independent risk factor for pancreatic     cancer and chronic pancreatitis. It has also been shown that the more a person smokes, the     worse his disease will be. Additionally, there are studies that show that smokers have     nutritional deficiencies. There are observational and retrospective studies that suggest that     pancreatic insufficiency may also be caused by smoking. However, this has not been     established, and the relationship has not been examined in a controlled manner. This study     examines the relationship between smoking and pancreatic insufficiency in patients who do not     have other pancreatic diseases.   "
101049|NCT01963468|"     The purpose of this study is to evaluate the effects of early intervention on language skills     for children with hearing loss.   "
99151|NCT01988324|"     Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in     treatment-decision making. Patients with ER-positive tumors can be treated with     anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy.     Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging     (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast     cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of     tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic     breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular     imaging of tumor AR- and ER-expression may well be of value for future treatment     decision-making.   "
99166|NCT01988129|"     Firefighters work some of the most demanding schedules known under highly stressful and     demanding conditions. The need to work frequent extended shifts and long work weeks leads to     acute and chronic partial sleep deprivation as well as misalignment of circadian phase. Sleep     disorders are common, costly, and treatable, but often remain undiagnosed and untreated and     it is likely that a significant proportion of firefighters suffer from undiagnosed sleep     disorders which will further impair their sleep and exacerbate fatigue.In the current     proposal, we aim to address the health, performance and safety issues related to fatigue in     firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue Management     Program (CFFMP) that we have termed 'Operation Healthy Sleep.'   "
99152|NCT01988311|"     This is a pilot study to finalize methods for a larger study being planned for the future.     This research is being done to characterize performance of tasks, brain functioning, and the     effects of psilocybin in individuals with a long-term meditation practice.      There are three different parts of the pilot study:        1. Effects of psilocybin on psychological function: This version of the pilot study will          involve 1 or 2 day-long psilocybin sessions, and several meetings and data assessment          visits. You will make a total of about 5 to 10 visits to our research unit (the BPRU on          the Johns Hopkins Bayview Campus).        2. Performance on behavioral and cognitive tasks: This version of the pilot study will          involve completing various behavioral and cognitive tasks at our research unit. You will          make a total of about 1-10 visits to our research unit (the BPRU on the Johns Hopkins          Bayview Campus).        3. Brain functioning: This version of the study will involve 1 to 3 brain imaging (MRI)          measurements. You will make a total of about 2 to 5 visits to our research unit (the          BPRU on the Johns Hopkins Bayview Campus). The MRI measurements will be taken at the          F.M. Kirby Research Center at the Kennedy Krieger Institute (across the street from the          Johns Hopkins Hospital).      People who are between the ages of 25 and 80 years old, who have a current, regular     meditation practice, and who meet the medical requirements may join.   "
99153|NCT01988298|"     Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity,     especially in developing countries. Postpartum hypertension can be related to persistence of     gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could     develop de novo secondary to other causes. The available data in the medical literature have     primarily focused on antenatal and peripartum management. There are few data regarding the     evaluation in women who are diagnosis with postpartum hypertension. Some medications that     cause vasoconstriction are often used for pain relief, in women having perineal lacerations,     episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal     antiinflammatory drugs that are associated with vasoconstriction and sodium and water     retention, this drugs can result in severe hypertension.      The purpose of this study is to evaluate maternal postpartum hypertension in women with     severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.   "
99154|NCT01988285|"     Purpose: To validate our previously developed model of risk factors for diagnosis of     eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in     diagnosis and monitoring of treatment of EoE. Participants: Up to a total of 800 participants     (approximately 400 with EoE and 400 without EoE) who are referred for upper endoscopy.     Procedures: This is a prospective cohort study. Patients will be compared with newly     diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after     treatment, and also reassess untreated controls. Data collection will include questionnaire     results, blood collection, and tissue collection (esophageal biopsies performed during upper     endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the     candidate biomarkers. Patients will be compared with newly diagnosed EoE to non-EoE controls,     obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated     controls. Data collection will include questionnaire results, blood collection, possible     saliva collection, possible urine collection, and tissue collection (esophageal biopsies     performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the     presence of the candidate biomarkers, including eotaxin-3 and IL-13.   "
99155|NCT01988272|"     The goal of this study is to develop imaging based methods to accurately determine the energy     absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy with I-131     tositumomab . The administration of the radioactive, iodine-131 labeled, monoclonal antibody     I-131 tositumomab, (also known as Bexxar) is part of the patient's clinical treatment     protocol. For the absorbed dose measurement, investigators at the University of Michigan are     evaluating a new Nuclear Medicine SPECT/CT imaging system . This new camera combines a CT     imaging system in addition to a Nuclear Medicine SPECT scanner. CT scans allow the doctors to     see a high quality picture of your internal organs. The Nuclear Medicine SPECT scanner allows     the doctors to see the uptake of the radioactive I-131 including the tumor sites. The     improved imaging using the SPECT/CT enables more accurate calculation of the energy absorbed     by tumor tissue and bone marrow. Using the results from these calculations and clinical     follow up data, the researchers will investigate the relationship between the absorbed dose     to the tumor and the patient's tumor response as well as the relationship between the     absorbed dose to the bone marrow and the bone marrow toxicity. These relationships can     potentially be used in the future by doctors to help determine how much radioactive I-131 to     administer to each patient to get optimal results.   "
99156|NCT01988259|"     To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an     apparatus to examine head-neck-coordination was constructed.      Two different surgical techniques will be compared:      Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open     approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well     as 3 and 12 month follow-up.      Hypothesis is that patients after MIS-approaches perform better in their     head-neck-coordination as patients with open approaches.   "
99157|NCT01988246|"     To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in     patients with diabetic retinopathy in the prevention of macular edema following cataract     surgery.   "
99158|NCT01988233|"     Investigators propose a randomized controlled trial (RCT) to test the efficacy of the revised     4-month BAILAMOS© program for improving lifestyle PA and health outcomes (physical and     cognitive function, self-reported functional limitations, disability) in sedentary older     Latinos at risk for disability relative to an attention control group.   "
99209|NCT01987544|"     Home ergometer training combined with online monitoring and regular telephone support could     prove to be a cost-effective method to improve physical performance and quality of life in     COPD patients.      The primary objective of the study is to demonstrate a significantly higher daily workout     time in patients that are monitored during home ergometer training with telephone support     compared to conventional home ergometer training. Consequently we expect an increased quality     of life related to the illness and a decreasing BODE-Index. A post-interventional lower     BODE-Index correlates with a reduced risk of hospitalisation and mortality.   "
99159|NCT01988220|"     Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory     deficits. Sensory impairments are often overlooked in the therapeutic setting, although they     lead to slower motor recovery.      Working hypothesis: The overall goal of this study is to examine the effectiveness of a     sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke     patients with sensory impairments. We assume that subjects to both groups will make progress,     which will be more significant in the experimental group.      Methods: Study population and design: Sixty individuals with chronic sensory impairment     following a stroke will be recruited. Patients will be randomly assigned to sensory     retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45     minute long intervention sessions, carried out within a 6 weeks period, and a home exercise     program. The person conducting the assessments will be blind to the treatment allocation of     the subjects. Outcome measures: The efficacy of the intervention will be determined in     relation to the International Classification of Functionality (ICF) developed by the World     Health Organization and will include assessments at the three domains defined by this model:     1. Body structure and function - determined by measures of the sensory capacity of the lower     more affected limb; 2. Activities - determined by measures of balance and gait; 3.     Participation - determined by measures of well-being and social reintegration.      Two new outcome measures, for ankle and knee position sense and for texture discrimination of     the foot, will be developed within this study. Data reliability measures on healthy     population, and test - retest measures in post stroke population with be collected.      Intervention: The experimental group will be treated by a perception learning oriented     protocol for sensory reeducation, to improve identification, localization and discrimination     of sensory stimuli, including electrical stimulation, texture and hardness discrimination and     position sense training. The control group will receive the same stimuli without the     attentive learning and discriminating component.      Importance: Scientific proof and focused recommendations for a potent therapeutic method for     the post-stroke population, allowing them better participation and quality of life.      Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.   "
99160|NCT01988207|"     The purposes of the proposed study are: a) to determine whether Flow Phonation can decrease     Laryngeal Resistance (Rlaw) in patients with Muscle Tension Dysphonia (MTD); and b)establish     the relationship between changes in measures of Rlaw and phonatory airflow to endoscopic,     perceptual, acoustic, and handicap assessment ratings. MTD can have a debilitating effect on     individuals who rely on their voices the most—teachers, preachers,salespeople,     singers—costing them time, money, and even their jobs. It can lead to vocal fatigue, pain,     and complete loss of voice. While treatments have emerged with some promising effects, no     treatments have proven to have long-term benefits to all patients. Our preliminary data     demonstrate Flow Phonation training resulted in significant decreases in Laryngeal Resistance     to phonatory airflow with associated improvements in voice quality and voice handicap     ratings. Sample size for our pilot study was small; no control group was utilized; and     outcome measures were limited. In the proposed investigation, a larger sample will be     obtained, a control group of participants receiving only Vocal Hygiene Training will be used     for comparison during the first 3 weeks, and a wider range of outcome measures will be     included over a longer period of time (1 year).   "
99161|NCT01988194|"     Many hospitalized patients experience pain during their hospital stay, and less than half     report adequate pain relief. Common treatments for pain include opioid medications, which     have associated side effects and complications. Research has shown that acupuncture is     effective for surgical, postoperative and cancer-related pain, nausea, and vomiting. More     research is needed on the effectiveness of adding acupuncture to routine care for     hospitalized patients. The objective of this study is to examine the effectiveness of     acupuncture delivered in a real-world setting according to the principles of traditional     Chinese medicine among hospitalized patients to manage pain and other symptoms. 250     hospitalized participants will be randomized in a 1 to 1 ratio to receive either 1) usual     care or 2) usual care with acupuncture offered (125 in each group). The primary outcome     measure will be change in daily pain intensity. Data on other symptoms, such as nausea,     vomiting, anxiety, and depression, as well as functionality and quality of life will be     collected in person, on a web-based survey, or via telephone follow-up. The aims of the study     are to examine the effectiveness of acupuncture to manage pain and other symptoms among     hospitalized patients; to evaluate the impact of acupuncture on patient satisfaction among     hospitalized patients; and to estimate costs and cost-effectiveness of acupuncture among a     subset of hospitalized patients.      The investigators hypothesize that compared to hospitalized patients receiving usual care     alone, hospitalized patients receiving acupuncture will have:        1. decreased pain severity        2. higher patient satisfaction   "
99162|NCT01988181|"     As kidney function declines, the ability to maintain water balance is impaired and is most     often treated with hemodialysis. The removal of excess water in hemodialysis often leads to a     sudden drop of blood pressure and causes symptoms of dizziness, light-headedness, cramping,     and chest pain. This sudden drop in blood pressure has been linked with complications of     heart attacks, strokes and even death. Research has focused on different ways to prevent     dangerous drops in blood pressure during hemodialysis. One way is the use of blood volume     monitoring biofeedback technology to monitor the patient's relative blood volume and     automatically reduce the amount of fluid that is being removed when the blood volume is low     to prevent the drop in blood pressure from occurring. This type of biofeedback device is     currently available on some hemodialysis machines and while this approach appealing, it is     not clear how effective this form of biofeedback is in preventing the drops in blood     pressure.      We plan to determine if the use of biofeedback based on the changes in the patient's blood     volume will reduce the number of sudden drops in blood pressure that occur during     hemodialysis. To do this, we will compare patients treated with this technology to current     hemodialysis practices and follow them for important adverse outcomes. The result of interest     will be the frequency of hemodialysis sessions complicated by a sudden symptomatic drop in     blood pressure. We also plan to monitor the amount of water in the different body     compartments, blood pressure, blood pressure medication use, markers of heart function, and     patient symptoms and quality of life.      We hope that by providing information on this technology we can reduce the sudden drops in     blood pressure in hemodialysis, the associated rates of serious disease or death, and improve     patient quality of life.   "
99163|NCT01988168|"     The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by     determining the patient recruitment rate and participation rate. The objective of the     full-scale trial is to determine the optimal method of skin closure after Caesarean delivery     in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion     of the placenta, seen typically after rupture of membranes with ascending polymicrobial     bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of     Caesarean delivery to skin closure with either staples or sutures. The women will be followed     at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site     infection and wound disruption, as well as evaluation of the scar and other secondary     questions.      The investigators hypothesis is that closure of skin with sutures will have a rate of wound     infection that is no higher than the rate of wound infection when closing skin with staples.     The investigators also hypothesize that closure with sutures will have a decreased rate of     wound disruption, increased patient satisfaction and decreased length of hospital stay     compared to skin closure with staples.   "
99293|NCT01986452|"     Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor     acceptance and adherence. There is a great potential to significantly improve the treatment     and care of these patients in a time economic way by telemonitoring the therapy in home     environment.      This study is planned to prove that telephone consultancy and motivation in times of recorded     decreasing CPAP therapy usage can improve adherence, neurological function and quality of     life.   "
99167|NCT01988116|"     The purpose of the study is to learn more about how treatment with vitamin D can affect iron     metabolism and blood levels of two hormones that control iron levels, hepcidin and     hemojuvelin in people with chronic kidney disease (CKD).      Iron is an essential mineral which is a major component of proteins that carry oxygen in the     blood. Problems with iron metabolism can lead to low blood levels (anemia), which can     commonly happen in people with CKD.      New research over the last decade has uncovered a new hormone called `hepcidin', which is     made in the liver and released into the blood. Hepcidin controls how much iron is in the     blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to     be high in people with CKD, and a recent small study in people with normal kidney function     showed that treatment with vitamin D decreased hepcidin levels.      Another protein, known as `hemojuvelin', has been recently discovered and is also thought to     control the amount of iron in the blood. The relationship between vitamin D and hemojuvelin     has never been studied before.      In this study, investigators would like to examine the effects of vitamin D on iron     metabolism and blood levels of hepcidin C and hemojuvelin in individuals with CKD.   "
99168|NCT01988103|"     This study will test the clinical effectiveness and safety of two orally administered doses     of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type     psoriasis.      Apremilast (CC-10004) is a new oral agent that is under clinical development for the     treatment of inflammatory autoimmune disorders such as psoriasis, psoriatic arthritis,     ankylosing spondylitis, rheumatoid arthritis, and Behçet disease.   "
99169|NCT01988090|"     This study is being done to look at the difference, if there is a difference between two     different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is     caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients.     The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent     aromatase inhibitor arthralgia (AIA).   "
99170|NCT01988077|"     A rationally designed combination of adoptive T cell therapy and ipilimumab could strongly     increase the proportion of CR patients, as well as the durability of response, as compared to     ipilimumab or TIL alone. The investigators hypothesize that the combination of those two     important modalities could result in a durable (≥ 1 year) complete response rate of 30% in     stage IV melanoma patients.   "
99171|NCT01988064|"     The aim of this study is to compare the efficacy of group training using a tutorial film and     one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in     the pulse rhythm in patients with cardiovascular diseases.   "
99172|NCT01988038|"     The design and establishment of the Polycystic Kidney Disease (PKD) Data Repository does not     require, and may be constrained by, a narrowly conceived hypothesis. However, the PKD     Repository has been designed to include demographic, clinical, biochemical, and genetic data     that will further explore the natural history of the disorder and assess the factors that are     likely to be associated with the progression of disease and the incidence of complications     including renal failure, cardiovascular disease, and stroke.   "
99173|NCT01988012|"     A multi-center, open-label single-arm study to evaluate the efficacy and safety of     tocilizumab administered as a single, weekly injection in adults with rheumatoid arthritis.     Combination therapy with methotrexate or other non-biologic disease modifying anti-rheumatic     drugs (DMARDs) was permitted.   "
99174|NCT01987999|"     The purpose of this study is to confirm the findings of an early study with prostate cancer     and to expand our knowledge of treating prostate cancer using an     Adenosine-5'-triphosphate(ATP)inhibitor.   "
99175|NCT01987986|"     To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of     edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.   "
99176|NCT01987973|"     The investigators hypothesize that the use of an allograft adjuvant to partial repair will     lead to improved shoulder outcome measure scores compared to partial repair alone in massive     rotator cuff tears.   "
99177|NCT01987960|"     To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or     sertraline (SER) on PTSD symptoms.   "
99178|NCT01987947|"     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will     assess the efficacy and safety of additional quilizumab therapy in adult patients with     Chronic Spontaneous Urticaria resistant to antihistamine treatment.   "
99179|NCT01987934|"     Oral cancer represents the sixth most common cancer worldwide whilst in Pakistan it ranks the     second most common cancer in either gender. Histologically, over 90% of oral cancer lesions     are squamous cell carcinomas which are diagnosed on the basis of histopathological analysis.     However, proliferation kinetics and nucleolar status are not clearly delineated by routine     H&E examination; thus making use of various proliferation markers imperative for the purpose.      Nuclear organizer regions (AgNORs) are associated with proliferative activity and represents     as a diagnostic aid in oral malignancies. Similarly, methyl green pyronin (MGP) stain has     also been valuable as a complement in routine histopathological studies of several neoplastic     entities.      Morphometric techniques offer an opportunity to quantify nuclear changes associated with     malignancy and may provide an objective basis for grading the tumors. The present study is     planned to analyze the morphometric parameters of the MGP stain in oral squamous cell     carcinoma, and in their various histological grades, and to assess if the MGP staining     parameters could give information on the aggressiveness of the malignant lesions of oral     cavity.      Sections from thirty cases of squamous cell carcinoma along with thirty cases of normal oral     mucosa will be evaluated for methyl green pyronin (MGP) and AgNOR staining. Morphometric     analysis of various MGP staining and AgNOR parameters would be performed using micrometer.     Statistical analysis of the results will be carried out using SPSS. Quantitative variables     will be expressed as mean ± Standard Deviation. Frequencies and percentages will be given for     qualitative variables.      It is hypothesized that oral squamous cell carcinoma will exhibit significantly higher MGP     staining and AgNOR staining parameters than normal mucosa of the oral cavity.   "
99443|NCT01984502|"     The feasibility of reducing fractions in early-stage laryngeal cancer has not previously been     prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose     fraction reduction study.   "
99210|NCT01987531|"     The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic     performance in patients with right ventricular dysfunction after open cardiac chamber cardiac     surgery.   "
99211|NCT01987518|"     French cohorte about polyposis digestive diseases   "
99306|NCT01986283|"     This study will determine the relative abuse potential of intact and chewed PF-00345439     (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release     (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.   "
99307|NCT01986270|"     The objective of this study was to compare the efficacy, toleration and safety of eletriptan     40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with     an acute migraine.   "
99180|NCT01987921|"     Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in     critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in     children is limited by single center retrospective data and inconsistent diagnostic and     stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a     composite of early injury signs and risk of disease, will predict severe subsequent AKI in     critically ill children and 2) the incorporation of urinary biomarkers into the renal angina     scoring system will improve the prediction of the severe injury. The AWARE study is conducted     to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill     children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI     criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry     will create the largest ever repository of information available on AKI in children.   "
99181|NCT01987908|"     Sickle cell disease (SCD) is a genetic blood disorder characterized by the presence of     sickle-shaped red blood cells. In the U.S. and the U.K. this occurs primarily in persons of     African origin. There is only one drug (hydroxyurea) approved to manage SCD, but it is not     fully efficacious and can produce medically significant side effects. Aes-103 is being     evaluated as a novel agent for the long term management of SCD. By directly reducing the     sickling process, Aes-103 has a different mechanism of action than hydoxyurea. The active     ingredient in Aes-103 is 5-hydroxymethyl furfural, a naturally occurring small molecule that     is chemically related to glucose.      This study will evaluate the safety and pharmacokinetic profile of two dosing regimens of     Aes-103 for up to 28 days in up to 50 adult subjects with stable SCD compared with subjects     receiving placebo.   "
99182|NCT01987895|"     This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin     in subjects with Clostridium difficile-associated diarrhea (CDAD).   "
99183|NCT01987882|"     The primary purpose of the project is to evaluate the effectiveness of different intervention     strategies to prevent or relieve symptoms associated with hip instability in children with     severe cerebral palsy, using the validated Caregiver Priorities and Child Health Index of     Life with Disabilities (CPCHILD©) questionnaire as the primary outcome measure of     health-related quality of life for this population.   "
99184|NCT01987869|"     Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis     gravid arum.   "
99185|NCT01987856|"     Single embryo transfer (SET) has been advocated as a means of reducing the risk of multiple     pregnancies, but has meant a reduction in pregnancy risk per embryo transfer. Embryo     aneuploidy has been cited as the primary reason for the low embryo implantation achieved in     human IVF. In the majority of IVF programs embryo selection has mainly been based on the     microscopic assessments embryo. Culturing embryos to the blastocyst stage as a selection     mechanism has seen an increase in implantation rates, presumably indicating that     morphologically normal blastocysts formed by day 5 of culture may have a reduced aneuploidy     rate. Morphological normality does, however, not completely preclude aneuploidy, with many     transferred and cryopreserved embryo bearing factors that may hold an increased risk for     implantation failure and miscarriage.      To select the conditions for single blastocyst transfer that will significantly improve     reproductive outcomes; increased implantation, reduced pregnancy loss and increased live     birth rates.   "
99186|NCT01987843|"     The primary objectives of the study are:        -  To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with          moderate to severe chronic plaque psoriasis.        -  To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to          severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on          Psoriasis Area and Severity Index (PASI).   "
99187|NCT01987830|"     This research study is exploring how the blood vessels in the participant's tumor change from     treatment with bevacizumab, and how these changes affect the way their tumor absorbs     temozolomide (TMZ).      The pilot part of this study is to evaluate the use of [11C] temozolomide PET (TMZ-PET) scans     and MRI scans to tell investigators more about how standard treatment with bevacizumab     affects the blood vessels in the participant's tumor, and how these changes affect the way     the participant's tumor absorbs temozolomide. Investigational means that the role of     TMZ-PET scans is still being studied and that research doctors are trying to find out more     about it.      Bevacizumab is approved by the U.S. Food and Drug Administration for use in people with the     participant's type of cancer. It works by blocking signals on a specific protein called     vascular endothelial growth hormone (VEGF), which plays a role in promoting the growth of     spread of tumor blood vessels. Bevacizumab is an anti-VEGF' agent because it is designed to     slow the growth of the participant's cancer.      Since anti-VEGF agents also affect normal blood vessels in the brain, they can inhibit the     way other drugs used in combination with bevacizumab are delivered to the tumor. Researchers     are looking for how bevacizumab affects delivery of chemotherapy, in this case temozolomide.      In PET scans, a radioactive substance is injected into the body. The scanning machine finds     the radioactive substance, which tends to go to cancer cells.      For the PET scans in this research study, the investigators are using a radioactive substance     called [11C] temozolomide, which is chemically identical to the prescription drug TMZ. TMZ is     FDA approved as a chemotherapeutic agent in cancer but [11C] temozolomide is an     investigational agent.      In this research study, participants will receive standard treatment with bevacizumab and     oral temozolomide as well as standard MRI scans. In addition, participants will undergo     TMZ-PET scans before and after treatment with bevacizumab. The first TMZ-PET scan will occur     7-13 days after starting treatment with oral temozolomide but before beginning treatment with     bevacizumab, day 1 after starting treatment with bevacizumab and 1 month after starting     bevacizumab. TMZ-PET scans will be given at the same time as a vascular MRI, which will     evaluate the changes in tumor blood flow, blood volume, and how receptive blood vessels are     while also measuring how much TMZ is in the brain.   "
99188|NCT01987817|"     This is a multi-center, randomized, double-blind placebo controlled study of efficacy and     safety of characterized peanut oral immunotherapy in peanut allergic individuals.   "
99189|NCT01987804|"     Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a     consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an     increased pH, which creates an environment more susceptible to infections . The mucosal     epithelium shows signs of severe senile atrophy and cytological examination demonstrate     increased number of the basal and parabasal cells and reduced number of superficial cells .     Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally     persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically     via the posterior pituitary. The most well known effects of oxytocin are its roles in female     reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to     exert positive effects on the proliferation of human vaginal mucosal cells from     postmenopausal women, an effect which could be attributed either to the direct stimulation of     new cell formation or to an increased production of other growth factors. The primary     objective is to investigate the dose relationsship of topical administrated Vagitocin on the     vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after     baseline.   "
99190|NCT01987791|"     To compare the safety and efficacy of 12 months of low dose prednisone with low dose     cyclosporine combined with entecavir in patients with thrombocytopenia associated with     HBV-related cirrhosis.   "
99191|NCT01987778|"     Today's women will live more than a third of their lives after menopause, i.e. with a changed     hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported     by about 75% of all women around menopause and may impair well-being, mental state, daily     activities and night sleep. Vasomotor symptoms are less prevalent in women who participate in     regular physical exercise. It is, however, still uncertain if physical exercise reduces     vasomotor symptoms.      The purpose of this randomized controlled study is to establish possible beneficial health     effects from 15 weeks of supervised resistance training (RT) on postmenopausal women.     End-points include effects from RT in postmenopausal women on        1. clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of          Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass,          browning of fat),        2. diagnostic variables (production of myokines as irisin, immunological markers) and        3. genetic variables (length of telomeres).      The control group will be offered resistance training after the intervention period.   "
99192|NCT01987765|"     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and     efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who     are treated with Relestat as standard of care in clinical practice.   "
99193|NCT01987752|"     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and     efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients     with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta     blockers treated as per standard of care in clinical practice.   "
99194|NCT01987739|"     This was a six-way crossover study with six single-dose treatment sessions. The profile of     acute effects on abuse potential measures of different almorexant doses was compared to that     of placebo and two doses of zolpidem   "
99195|NCT01987726|"     This pilot clinical trial studies comprehensive gene sequencing in guiding treatment     recommendations in patients with metastatic or recurrent solid tumors. Studying samples of     blood and tissue from patients with cancer in the laboratory may improve the ability to plan     treatment.   "
99196|NCT01987713|"     Methods: This study will be a three-year mixed methods study, including the identification of     obesity issues among children with chronic conditions in the first phase study     (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study     (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle     intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry,     healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit     will be conducted. By using the literature review, meta-analysis and focus-research     approaches to develop a healthy lifestyle intervention protocol in the second year program.     The protocol will be tested on a sample of school-age children with asthma, to develop a     school-based and family-involved healthy lifestyle intervention. Finally, the protocol will     be undertaken on children with asthma aged 10-15, by using an experimental (pretest-posttest)     design with repeated follow-ups. The research subjects will be randomly assign to condition     of receiving intervention or control; the measurement of the outcome across 4 observations,     to assess both group differences (experimental comparison), and changes within groups. The     interventions consist of healthy diet (X1), regular exercise (X2), and booster energy     balance-related behaviors (BEBRB) (X3). The observations start from baseline (O1), then have     three observations (O2, O3, O4) at 3-month interval respectively. Outcome indicators include     height, body weight, waist circumference as well as healthy life style modification present     by diet record, exercise diary, healthy life environments. The research subjects will consist     of randomly sampled school-age children and their fathers (or mothers), school teachers and     school nurses. The approximate sample size is estimated by power analysis and dropout rate,     the eligible sample size will be 200 and 160 pairs of children with their parents, school     teachers and nurses in the first and third year respectively.   "
99197|NCT01987700|"     The primary objective of this study is to examine and compare the outcomes associated with     the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine     acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large     complicated abdominal wall hernias.   "
99198|NCT01987687|"     Postprandial glycaemic control is an important risk factor for the development of type 2     diabetes, cardiovascular disease and all-cause mortality.      Previous research has demonstrated that exercise performed in the postprandial state     paradoxically results in a deterioration in glucose tolerance in the immediate post-exercise     period (Gonzalez et a. 2013; Gonzalez and Stevenson 2013). This study aims to assess the     timecourse of this post-exercise effect.   "
99199|NCT01987674|"     The purpose of this study is to investigate if a pre-meal drink containing proteins can     positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison     with a placebo is included.   "
99200|NCT01987661|"     15 COPD patients will be surveyed in this prospective randomized crossover pilot study     concerning non invasive ventilation. Patients will be treated over 2 nights in randomized     order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography     (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by     evaluating the PSG and pCO2 values over night.      Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on     pCO2 values over night.   "
99201|NCT01987648|"     Regarding the postoperative care strategies following elective craniotomy procedures there is     little evidence. Many neurosurgical departments prefer these patients to remain intubated and     sedated for many hours postoperatively to minimize hemodynamic and respiratory distress in     fear of early postoperative complications such as rebleeding or seizures. In this prospective     observational study the investigators aim to show that early tracheal extubation following     elective brain surgery is feasible and safe.   "
99202|NCT01987635|"     Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure     long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to     complete flexible ring substitutes, the most recent ones are aimed to restore the natural     saddle shape of the mitral annulus, in order to decrease the stress tension on both mitral     leaflets and chordal attachments. So far, even for flexible ring devices, the sustained     flexibility of the device remained unproven, probably by cicatricial fibrotic tissue ingrowth     after implantation.      Due to specific structural characteristics based on a nitinolstent with carbofilm-coating,     the MEMO 3D ring device of SORIN claims preservation of the ring flexibility during the     cardiac cyclus. Consequently, mitral anuloplasty with this device is expected to decrease the     stress during the systolo-diastolic movements of the valve, and so, improve the late     durability of the repair.      Echocardiography is the first-line technique for mitral valve assessment after surgical     repair, for both intra-operative evaluation and serial follow-up of valve function. Recently,     three-dimensional echocardiography has been introduced into clinical practice, affording     qualitative and quantitative measurement of mitral valve function and size during the cardiac     cycle.This method allows to quantify precisely the excursion of the mitral annulus between     systole and diastole.      The aim of this study is to analyse the systolo-diastolic movement of the mitral annulus     after the use of an anuloplasty with the SORIN MEMO 3D device, after surgical implantation     and its sustainability, 1 year after implantation.      This hypothesis is tested in a case-controlled comparison with a standard used rigid ring     device.      Therefore, 3-D echocardiography will be performed at the time of surgical repair, and after 1     year, to define the size and surface change of the mitral anuloplasty device during the     cardiac cycle.      Based on a sample size calculation, 10 patients in each comparison group will be included,     suggesting a study cohort of 20 patients eligible for mitral valve repair.   "
99203|NCT01987622|"     Acupuncture is widely used to manage chronic low back pain. Mounting evidence suggests the     beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor     adverse events. However, little information exists regarding the effects and safety of     acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that present     chronic low back and leg pain.      The investigators aimed to assess the overall effectiveness, safety, and feasibility of     acupuncture in combination with usual care (as opposed to usual care alone) for patients with     symptomatic degenerative lumbar spinal stenosis.      The hypotheses of this study are as follows:        1. A set of acupuncture sessions in combination with usual care can provide greater          functional improvements than usual care alone .        2. A set of acupuncture sessions in combination with usual care can provide greater pain          reduction than usual care alone .      The study aims to include 50 participants (25 in the acupuncture group and 25 in the usual     care group).   "
99204|NCT01987609|"     Dendritic cells are a key component of the inflammatory response seen in psoriasis. Several     current psoriasis therapies have been shown to reduce the number of dendritic cells in     patients with psoriasis, leading researchers to believe that therapies specifically targeting     dendritic cells may lead to improvement in psoriasis. Research recently conducted in Dr.     Gallo's lab at the University of California San Diego has shown that transgenic mice     overexpressing the enzyme hyaluronidase have a significant decrease in the number of     dendritic cells in the dermal component of their skin compared to wild type mice. If     hyaluronidase overexpression in humans also decreases the number of dendritic cells in the     dermis, then hyaluronidase therapy may improve the clinical presentation of psoriasis. In     order to test this hypothesis, recombinant human hyaluronidase (Hylenex®) will be injected     subcutaneously below a psoriatic plaque in human psoriasis patients every week for a total of     4 weeks. Each week the clinical appearance of the plaque will be documented. At the final     visit skin biopsies of the treated plaque will be taken to visualize the histology of the     plaque and look for changes in expression of different inflammatory markers.   "
99205|NCT01987596|"     This randomized phase III trial studies flexible administration of filgrastim after     combination chemotherapy to see how well it works compared to fixed administration of     filgrastim in decreasing side effects of chemotherapy in younger patients with cancer. Cancer     chemotherapy frequently results in neutropenia (low blood counts) when patients are     susceptible to severe infections. A medicine called G-CSF (filgrastim) stimulates bone marrow     and daily filgrastim shots are commonly used to shorten neutropenic periods and decrease     infections after chemotherapy. Since filgrastim is customarily used on a fixed schedule     starting early after chemotherapy and there are data that early doses may not be needed, this     study tests new flexible schedule of filgrastim to optimize its use by reducing the number of     painful shots, cost of treatment, and filgrastim side effects in children with cancer     receiving chemotherapy.   "
99206|NCT01987583|"     This research proposal is submitted to fulfill the requirement of the PHD degree of Community     Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi     Arabia.      Background: Cupping is an ancient treatment remedy that has been used for many centuries in     many parts of the world. In the Middle East, Wet cupping Hijama is still a popular     treatment because of its religious background. Despite of that, it still has little     scientific evidence that proves its efficacy. Many hijama healers claim that they have     observed dramatic improvement in Blood pressure control of hypertension patients. Not many     studies support that. This study should help to prove or disprove this hypothesis.      Objectives:        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure          patients.        -  To assess the incidence of wet cupping side effects in the intervention group.      Methods: The study design is a randomised controlled trial. There will be an intervention     group of high blood pressure patients who will perform hijama in addition to their usual     management, and a control group of high blood pressure patients who will receive their usual     anti-hypertension management only. There will be 8 weeks follow up period. After that, data     entry, analysis and interpretation will take place.      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients   "
99207|NCT01987570|"     Generating critical levels of power is a prerequisite for performing simple daily activities,     such as rising from a chair or climbing stairs. For a young healthy person these activities     can be performed easily, however after a prolonged period of forced inactivity (such as     during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle     mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An     enzyme involved in the production of free radicals in various experimental models, including     immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely     used in clinical practice, its effect on the maintenance of muscle mass after an     immobilization protocol is unknown. Thus, the major aim of this clinical trial is to     determine the effect of allopurinol administration on the prevention of muscle mass loss in     immobilized subjects.      This is a prospective, randomized study in which fifty young male subjects (aged between 25     and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization     the patients will be assigned randomly to one of two experimental groups, one treated with     allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the     same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization     period, which will last fifteen days. This medication will be delivered to the patients when     they agree to participate in the clinical trial. They will be immobilized by posterior knee     splint, preventing use of that leg.      We will determine muscle mass loss by performing two magnetic resonances of both legs before     and after the immobilization period. We will also take two blood samples (before and after     immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls,     and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin),     as well as vitamin D levels.   "
99208|NCT01987557|"     Treadmill training has been shown to be beneficial for reducing motor symptoms of Parkinson's     disease (PD). The mechanisms for the therapeutic effects of treadmill training remain     unknown. However, specific types of intrinsic feedback generated from muscle spindles (detect     changes in length of muscle) and golgi tendon organs (detect muscle force) seem to be an     important factor for achieving the reductions in motor scores. This study will compare a     treadmill program that generates a high rate of intrinsic feedback to a treadmill program     focused on generating a high magnitude of intrinsic feedback.   "
99294|NCT01986439|"     The purpose of this project is to remove barriers to obtaining contraceptive methods,     including the most effective and expensive methods. The study seeks to remove the financial     and knowledge barriers and promote the most effective contraceptive methods to reduce     unintended pregnancy rates at the population level.   "
99295|NCT01986426|"     The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral     dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune     responses, as monotherapy or in combination with ipilimumab or pembrolizumab.   "
99213|NCT01987492|"     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will     evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of     participants to achieve lower daily doses of OCS, among those with severe     corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed.     Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a     double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may     continue into a 32-week active treatment extension (ATE) period, during which all     participants will receive lebrikizumab treatment. Following completion of the ATE period,     participants who have both tolerated and derived benefit from treatment with lebrikizumab may     continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants     will transition to 24 weeks of safety follow-up upon discontinuation of study drug.   "
99214|NCT01987479|"     This multi-center, open-label single arm Phase IIIb study will evaluate the safety and     efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination     with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in     participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic     DMARDs.   "
99215|NCT01987466|"     Postresuscitation disease is a constellation of disorders related to whole-body ischemia and     reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other     organ. In previous study more than one-third of patients resuscitation from out of hospital     cardiac arrest developed renal dysfunction. In acute kidney injury, NGAL is an earlier marker     compared with serum creatinine.      Cardiac arrest and severe asphyxia result in global brain ischemia. In previous study serum     NGAL correlated with hypoxic ischemic encephalopathy in asphyxiated neonate.      This study was designed to assess serum NGAL level in postresuscitative patients to evaluate     its relation to hypoxic brain injury severity, and its clinical utility for early detection     of acute kidney injury in these patients.   "
99216|NCT01987453|"     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability     of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin     (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have     participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve     sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification     (LLOQ) 24 weeks after last dose of study drug (SVR24).   "
99217|NCT01987440|"     Pelvic examination, an important part of gynecologic oncology patients to help detect cancers     recurrence or infections.Despite its importance, many women are reluctant and anxious about     the procedure because of fear, as well as discomfort and pain. The objective of this study is     to estimate whether using lubricating gel decreases patient pain during speculum insertion     compared with using water in gynecologic oncology patients   "
99218|NCT01987427|"     APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of     12-week duration in overweight and obese adults. Approximately 225 subjects will be     randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations     of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15     mg once daily (QD), or lorcaserin alone.   "
99219|NCT01987414|"     The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined     with the occupational therapy task-oriented approach on functional performance for persons     with a hemiparetic arm.      Hypotheses of this study are:        1. participants who wear the forearm rotation orthosis will demonstrate significantly          greater improvement in functional performance and active range of motion of forearm          rotators compared to those who do not;        2. all participants who receive the occupational therapy task-oriented approach          intervention will demonstrate significant improvement in functional performance; and        3. all participants who receive the occupational therapy task-oriented approach          intervention will demonstrate improvement in motor function of the upper extremity.   "
99220|NCT01987401|"     The primary objective of CSP #595, Service and Health During the Iraq and Afghanistan Era,     is to characterize the impact of deployment to Iraq and Afghanistan on the respiratory health     of Veterans. The purpose of the pilot study is to determine the willingness of Veterans who     served during the Iraq and Afghanistan Era to provide health and military service     information. This information will help us design a larger national study.   "
99221|NCT01987388|"     The objective is to develop a new metabolic flexibility biomarker, which has application in     the study of changes diet and exercise on fuel management in humans. The new biomarker     involves the characterization of an individual's metabolic flexibility utilizing room     calorimeters rather than the current method, which is based on glucose clamp data. It is     hypothesized that this new metabolic flexibility method will be a useful and noninvasive     biomarker for measuring adaptation to exercise and diet challenges.   "
99222|NCT01987375|"     This study is an open label, single institution, Phase 1 dose-escalation study to determine     the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell     carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a     dose of an approved head and neck cancer drug (Cetuximab) along with an investigational study     drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to surgery     that attaches to cancer cells and appears to make them visible to the doctor when he uses a     special camera during the operation. The investigators are evaluating whether or not the use     of the study drug along with the special camera will better identify the cancer while     patients are in the operating room.   "
99259|NCT01986894|"     This is a single-center, randomized, double-blind crossover study with four treatments, four     periods and four sequences to investigate the effects of orally administered pomalidomide on     QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically     indicated dose for multiple myeloma [MM] as per the United States Package Insert [USPI] of 4     mg and supratherapeutic dose of 20 mg) and placebo treatments will be double-blinded.     Moxifloxacin (positive control) will be administered in an open-label fashion to determine     the sensitivity of the assay. The core electrocardiogram (ECG) laboratory and ECG readers     will be blinded to all study treatments and sequences.   "
99308|NCT01986257|"     The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy     (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.   "
99223|NCT01987362|"     This is a Phase 1, non-randomized, dose-escalating, open label, multi-center study to be     conducted in two parts (Part A and Part B). RO6870810 is a small molecule, non-covalent     inhibitor of bromodomain and extra-terminal (BET) family of bromodomains. This study is     designed to characterize the safety, tolerability, pharmacokinetics and anti-tumor activity     of RO6870810 in participants with histologically confirmed solid tumors with progressive     disease (PD) which is refractory or intolerant to standard/approved therapies. In Part A,     RO6870810 will be administered by subcutaneous (SC) injection daily for either 21 consecutive     days in a 28-day cycle or for 14 consecutive days in a 21-day treatment cycle in participants     with advanced solid tumor malignancies to determine the maximum tolerated dose (MTD) and     dose-limiting toxicities (DLT). In Part B, RO6870810 will be administered at a dose up to the     MTD to further characterize the safety profile and biological effect in a subset of     participants with advanced solid tumor malignancies. It is anticipated that a total of 84     participants will be enrolled in to this study (54 in Part A and 30 in Part B). In addition,     it is expected that up to 20 participants with histologically confirmed nuclear protein in     testis (NUT)-midline carcinoma (NMC) with progressive disease requiring therapy will be     enrolled in the sub-study of Parts A and B. In addition, up to 20 participants with diffuse     large B-cell lymphoma (DLBCL) may be enrolled at selected study sites.   "
99224|NCT01987349|"     This study will compare influenza vaccine responses in monozygotic and dizygotic twins.   "
99225|NCT01987336|"     To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc     urine sample would also be collected from the same subject, and analyzed.   "
99226|NCT01987323|"     Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of     latanoprost in treating glaucoma.      Hypothesis: The investigators have already evaluated carrier stability, drug partitioning, in     vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes upon     subconjunctival administration in both rabbit and monkey eyes. Therefore, the investigators     hypothesize that this would be safe and efficacious in humans as well.      Methodology: A pilot study to assess a liposome formulation containing latanoprost. The     investigators will recruit 6 study subjects with eyes that have raised IOP, for     subconjunctival injection of this liposome formulation. The recruited eye will be injected     and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the     eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.      Importance: If proven safe, this method of drug delivery could potentially be used for     treatment of raised intraocular pressures in blinding conditions such as glaucoma.   "
99227|NCT01987310|"     The aim of the current study is to evaluate the association of fatty liver severity and     endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the     impact of statin treatment compared to usual care or life style modification on endothelial     function, liver steatosis and fibrosis.   "
99228|NCT01987297|"     In this prospective randomized study for patients with newly diagnosed acute promyelocytic     leukemia, patients will be randomized into two groups which received retinoic acid and     arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.   "
99229|NCT01987284|"     Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly people.     Much attention has recently been drawn to the strong relationship between the systolic blood     pressure and cardiovascular morbidity.      In previous clinical studies carried out in individuals with normal blood pressure at     baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the     effect on systolic blood pressure in hypertensive patients will be larger or equal to the     fall seen in normotensive patients.   "
99230|NCT01987271|"     The purpose of this study is to evaluate the effect of noninvasive ventilation (NIV) in     functional capacity of children and adolescents with cystic fibrosis.   "
99231|NCT01987258|"     Four months of interval walking training (IWT) is superior to energy-expenditure matched     continuous walking training (CWT) with regards to weight loss and improvements in glycemic     control. The reason for this is unclear. One potential explanation for the differential     outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as     the elevated oxygen consumption measured during the hours following an exercise bout. A large     EPOC means greater energy expenditure which, if energy intake does not change, leads to a     greater weight loss. This weight loss may subsequently improve glycemic control        -  Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic          control in type 2 diabetics and to assess mechanisms responsible for differences (if          any). It is hypothesised that IWT will be more advantageous for improving glycemic          control.        -  Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC.          It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.   "
99232|NCT01987245|"     Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early     cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation     (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early     identification ROSC is very important. Now there is no an easy, non-invasive and real-time     method to monitor the quality of CPR. In this study the investigators hypothesis the pulse     oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR     to the physicians.   "
99233|NCT01987232|"     The purpose of this study is to determine the maximum tolerated dose and assess the safety,     tolerability and activity of carfilzomib given in combination with carboplatin and etoposide     as initial therapy for patients with extensive-stage small-cell lung cancer (ES SCLC).   "
101067|NCT01963234|"     Implementing a mobile-phone based system for drug use disorders in primary care settings.   "
99260|NCT01986881|"     A study of the cardiovascular outcomes following treatment with ertugliflozin in participants     with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of     this study is to assess the cardiovascular safety of ertugliflozin. This trial includes a     pre-defined glycemic sub-study in participants receiving background insulin with or without     metformin, a pre-defined glycemic sub-study in participants receiving background sulfonylurea     monotherapy, and a pre-defined sub-study in participants receiving background metformin with     sulfonylurea (all fully-enrolled).   "
99309|NCT01986244|"     The purpose of this study is to prospectively evaluate the functional outcome and patient     satisfaction of total ankle replacement for tibio-talar osteoarthritis.   "
99234|NCT01987219|"     Evaluate the effects of bronchodilator therapy on respiratory function. Our overall goal is     to determine whether, in patients with familial dysautonomia (FD), there is a component of     airway obstruction that is reversible. To this end, we will evaluate airway resistance before     and after receiving the anti-cholinergic ipratropium (Atrovent ®) and the beta-2-agonist     albuterol (ProVentil®/Ventolin®). We predict that the response to either drug will depend on     the underlying level of sympathetic and parasympathetic activity and airway tone. We will     then determine the cardiovascular effects of inhaled ipratropium and albuterol in patients     with FD. Because patients with FD have fewer sympathetic neurons and denervation     supersenstivity, we predict that following albuterol inhalation, there will be non-selective     activation of alpha-1-adrenergic receptors. Furthermore, because of a congenital defect in     the afferent baroreceptor neurons that sense blood pressure, we suspect that the resulting     vasoconstriction will be unopposed leading to a pressor effect. We hypothesize that     inhalation of the anti-cholinergic ipratopium will produce little rise in heart rate, due to     the extent of parasympathetic denervation to the heart.   "
99235|NCT01987206|"     The goal of this proposed study is to explore the feasibility of using a PID     (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control)     controller algorithm in an artificial pancreas system, all other components and study design     being equal.      The study consists of an evaluation of either type of control algorithm as a part of the     Artificial Pancreas (AP) device during two periods of 27.5-hour closed-loop control in a     clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA) separated by a     minimum of 5 days and a maximum of 2 weeks. The 27.5-hour period includes: 2 announced meals     (dinner and breakfast of 65g and 50g CHO respectively) preceded with a dose of rapid-acting     insulin equivalent to 100% bolus based on each subject's Insulin to Carbohydrate (I:C) ratio     and 1 unannounced meal (lunch of 65g carbohydrates, same meal content as dinner); complete     night from 12:00 am to 7:00 am. The goal is to demonstrate that the AP device is able to     maintain the subject blood glucose within a safe range at all times.   "
99236|NCT01987193|"     The purpose of this study is the development of noninvasive (having no direct contact)     detector and electronic system that will directly measure tumor blood flow rate.   "
99237|NCT01987180|"     The goal of this research is to develop and pilot the NICU-2-Home service, a health     information technology (IT) concept centered on a smart phone app. NICU-2-Home will provide     support to parents of very low birth weight (VLBW) infants as they transition from the NICU     to their homes and eventually establish a medical home with the infant's pediatrician. Once     the app is developed, we will conduct a feasibility study with randomization to pilot test     the ability of NICU-2-Home app to (a) improve parent's self-efficacy and confidence in caring     for their VLBW infant, (b) decrease parental stress, and (c) enhance involvement with their     VLBW infants compared to controls.   "
99238|NCT01987167|"     The goal of the study is to determine the earliest structural changes in the optic nerve     during the acute event and during the twelve months of recovery following Acthar treatment.   "
99239|NCT01987154|"     To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed     protein source for routine nutrition.   "
99240|NCT01987141|"     Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM)     recommended weight gain. To date, there are no randomized controlled trials studying the use     of the electronic medical record to alert providers to initiate the counseling of patients on     the IOM gestational weight gain recommendations.      In the investigator's planned study intervention, using the EPIC EMR system, an electronic     alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This     alert will remind providers to counsel patients on the recommendations for gestational weight     gain. The control group will receive standard prenatal care, without electronic alerts     generated regarding BMI and gestational weight gain.      The investigators hypothesize that a higher percentage of patients who receive the     intervention will meet the IOM guidelines for weight gain.   "
99241|NCT01987128|"     Aim of this study is to demonstrate the advantages of intraneural injection over extraneural     injection in terms of onset and duration on peripheral block. In addition we will evaluate     the frequency of possible adverse effects.   "
99242|NCT01987115|"     Trigger finger is a relatively common disorder affecting the hand. There is limited evidence     on the efficiency of traditional physiotherapy in treating this condition. Fascial     manipulation is a gaining momentum manual therapy method. To our knowledge the efficiency of     fascial manipulation techniques in the treatment of trigger finger was not reported. The     purpose of this study is to investigate the efficiency of the technique and to compare it     with the traditional physiotherapy treatment.   "
99243|NCT01987102|"     An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the [6R]     5,10-methylenetetrahydrofolate Dose with Most Favorable Safety Prospect and Confirmed Ability     to Mitigate High-Dose Methotrexate Induced Toxicity during Treatment of Osteosarcoma Patients   "
99244|NCT01987089|"     Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been     associated with anxiety and depressive symptoms, as well as an increased risk of relapse back     to the drinking.      Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the     recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may     be efficacious for insomnia during recovery.      The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a     post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if     an improvement in the insomnia is associated with an improvement in the underling alcoholism     and the daytime functioning. On an exploratory basis, the association of a first-degree     family history of alcoholism with the insomnia severity and treatment response will also be     evaluated.   "
99255|NCT01986946|"     1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar          Spinal Fusion: A Prospective Randomized Study        2. Purpose of the Study - This prospective randomized study will enroll 200 patients          undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary          objective is to determine the effect of epidural analgesia, as compared with standard          care, on post-operative analgesia.      Hypothesis:      The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with     epidural catheter placement will have superior post-operative analgesia compared to patients     undergoing standard care.   "
99245|NCT01987076|"     Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe multiorgan     adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake. DRESS syndrome     is defined by the combination of clinical manifestations, cutaneous, visceral and biological     disturbances. Its prognosis is directly linked to severity of visceral involvement, with a     mortality evaluated above 10%.      Considering curative treatment, there is no consensus. Until now, no controlled trial has     been performed. Systemic steroids are mainly used in first intention, in particular for     management of visceral involvements, whatever their severity. From clinical practice, topical     steroids are often used and could be helpful in the therapeutic management of DRESS.      We propose to evaluate systemic steroids versus very potent topical steroids in a     multicentric randomized controlled trial including defined moderate DRESS, ie the     non-inferiority of very potent topical steroids in terms of remission of visceral involvement     at Day30 and the superiority of very potent topical steroids in terms of delay to remission     of skin involvement.   "
99246|NCT01987063|"     The purpose of this study is to determine the best obstetrical practices for twin delivery.   "
99247|NCT01987050|"     The proposed study is a randomized, double-blind, placebo-controlled study of the value of     adjunctive intranasal oxytocin added to existing antipsychotic treatment compared with     adjunctive placebo in subjects with schizophrenia. Enrolled subjects will receive 6 weeks of     treatment with one of the following adjunctive to a stable antipsychotic regimen: 1) 84     International Units (IU)/day intranasal oxytocin (42 IU twice a day) 2) 168 IU/day intranasal     oxytocin (84 IU twice a day) or 3) intranasal placebo. The study will be conducted over 2     years. Approximately eighty subjects will be entered into the study. We hypothesize that     augmentation of antipsychotics with intranasal oxytocin will significantly improve     psychopathology ratings as compared to placebo and an improvement in certain cognitive     functions may also be observed.   "
99248|NCT01987037|"     The aim of the study is to describe the feasibility of the passation of the assessment     battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a     diagnosis of autism spectrum disorder: number and type of evaluable events, number and type     of tests with a deficit compared to the standard results.   "
99249|NCT01987024|"     It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total     duration of hospitalization for patients with a risk of preterm labor before 32 weeks of     gestation without increasing the number of preterm labour.      Methods Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/-     described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized     to receive tocolytic drugs and antenatal corticosteroid therapy according to our gold     standard protocol. After 48 hours, they will be assessed by examination, external     tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be     included and randomized into 2 groups of 210 patients each. The first group A will benefit     from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical     and ultrasound assessment); whereas the second group, B, will have the benefit of the     detection of phIGFBP-1.If the result proves negative, patients could be discharged early at     day 2. In the case of a positive result, patients will follow the standard procedure because     of the low positive predictive value of the test. The main outcome is the total duration of     hospitalization.      Study duration The trial period will be 36 months.      Expected results The use of detection of IGFBP-1 would enable us to select patients at risk     and to decrease the duration of hospitalization in the case of a negative result.      Perspectives The negative predictive value of phIGFBP-1 test could be useful to select     patients with stabilized risk of preterm labor, who could be discharged early. Moreover it     could be used, in the Perinat Sud network, to decide if patients with a risk of preterm labor     would benefit from hospitalization in a level II or III maternity ward.   "
99250|NCT01987011|"     The purpose of this study is to evaluate the immunogenicity and safety of the investigational     vaccine in the subjects during their participation in the study.   "
99251|NCT01986998|"     The investigators plan to carry out a multicenter randomized clinical trial and MRI study of     high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and     demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in     acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this     therapeutic regimen because it is safer for the patient (less adverse effects) and less     costly to the healthcare system.   "
99252|NCT01986985|"     The objective of this study is to gather image and associated data to of a pre-market PET/MRI     scanner and to use the data for regulatory submission and future product development and     marketing. Clinical data is required in order to test the MR attenuation correction of PET     data. These aims can only be accomplished through a clinical study.   "
99253|NCT01986972|"     Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by     brushing with and without conventional toothpaste. Settings and Design: Twenty-four students     aged 17 to 28 years old participated in this randomized clinical trial.      Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group     (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of     cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and     after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were     performed by paired sample t test.   "
99254|NCT01986959|"     Background: There is controversy regarding the postoperative effects of periodontal dressing     on the periodontium, pain and discomfort. The aim of the present study was to compare     postoperative pain following surgical crown lengthening with and without the use of     periodontal dressing.      Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients.     Following surgical crown lengthening, the individuals were randomly allocated to the     periodontal dressing group (PDG) and control group (CG - non-placement of periodontal     dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale     (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative     infection, stability of the gingival margin and type of healing were also evaluated.   "
99256|NCT01986933|"     To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic     dermatitis patients who are inadequately controlled by or intolerant to topical therapy   "
99257|NCT01986920|"     Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on     the back of subjects.   "
99262|NCT01986855|"     This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in     participants with type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have     inadequate glycemic control on background antihyperglycemic therapy. The duration of this     trial will be up to 67 weeks. This will consist of a 1-week Screening Period, a 10-week     wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week     double-blind treatment period, and a 14-day post-treatment follow-up period. The primary     objective of this trial is to assess the A1C-lowering efficacy of the addition of     ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition     of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of     placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.   "
99263|NCT01986842|"     Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining     skeletal muscle mass with aging, it is important to optimize the adaptive response to food     intake. However, a paucity of information is available describing the effects of habitual     dietary protein intake (i.e. either high or low amounts of dietary protein consumed on a     regular basis), on the subsequent meal-induced stimulation of muscle protein synthesis. An     adaptation to a diet of several days or weeks may involve splanchnic and/or skeletal muscle     adaptations that may further enhance, or decrease, the amino acid sensitivity of muscle     protein synthesis after protein ingestion.      The aim of this study is to investigate the effect of a habitual (14 days) high protein diet     when compared with low protein diet on digestion and absorption kinetics and the subsequent     muscle protein synthetic response to dietary protein ingestion.   "
99265|NCT01986816|"     The purpose of this study is to investigate the cost of treatment and adverse efffects therof     corresponds to quality of life improvements and expected wheightloss.   "
99266|NCT01986803|"     This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority,     European multicenter clinical trial.      The primary objective of this study is to assess the neointimal healing score (as evaluated     by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and     treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS)     at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore,     the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed.      It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully     bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic     drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial     healing process and potentially reduce late stent thrombosis in patients presenting with     STEMI.      This is a preparatory trial in anticipation of a major outcome study.   "
99267|NCT01986790|"     The overall goal of the study is to better understand how communication strategies can help     people make decisions about health insurance plans.      This study aims to:        -  (Aim 1) Examine currently uninsured individuals' understanding of terminology and          details of health insurance plans;        -  (Aim 2) Apply three recommended strategies for communicating information about health          insurance plans;        -  (Aim 3) Test the effects of these strategies in a randomized experiment.   "
99268|NCT01986777|"     This is a double-blind, placebo-controlled, study testing whether LDX improves cognitive     function and EF in 20 postmenopausal women who report onset of cognitive difficulties after     oophorectomy (with or without subsequent chemo/adjunctive therapy). Brain imaging is included     at critical time points to obtain objective data regarding effects of LDX as well as     potential predictors of resilience in the face of oophorectomy.   "
99289|NCT01986504|"     The Transplant Infectious Diseases Prospective Cohort Study facilitates the prospective     identification and collection of data of infectious disease complications in order to     determine the epidemiology, risk factors, and outcomes of patients who receive solid organ or     stem cell or plastic surgery transplants at Johns Hopkins and other transplant centers. It is     essential for the care and treatment of this population to employ a mechanism for     investigators to centralize these datasets, using standardized definitions of infectious     complications. This protocol outlines the procedures to be utilized in order to prospectively     follow the diagnosis and treatment of infectious complications in transplant patients.   "
99328|NCT01985997|"     This is an observational post-marketing study conducted in children and adults immunized with     Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP)     sites.   "
99269|NCT01986764|"     This project seeks to address cognitive disturbance, which is a frequent adverse sequelae of     riskreducing bilateral salpingo-oophorectomy (RRSO) with or without post-procedure     chemotherapy and adjunctive treatments. RRSO after completion of childbearing is recommended     for prevention of ovarian and breast cancer in women with BRCA1/BRCA2 mutations and standard     of care for women with some forms of hormone-responsive cancer. Knowledge regarding the     impact of this procedure, with or without chemotherapy, and subsequent hypogonadism on brain     health is less than adequate. Premenopausal women who undergo an acute surgical menopause are     at greater risk for verbal memory decline and executive function (EF) complaints, but as of     yet, we cannot predict who is going to experience these adverse sequelae, nor do we have     targeted prevention or treatment strategies other than hormone therapy, which is not an     option in many cases and not always effective. An idealized sample as women who are planning     for a RRSO will undergo brain imaging and behavioral assessments pre- and post-surgery as     well as pre-/post-treatment with E2 or the psychostimulant, lisdexamphetamine (LDX;     Vyvanse®).   "
99270|NCT01986751|"     Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking     you to take part in a research study. This research study will test whether adding a medicine     called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than     a day after surgery. We are looking for ways to make them work better and last longer.     Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is     investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve     blocks may also decrease the amount of pain medicine a person has after surgery. All people     who enter this study will receive a nerve block with the normal medicine, but half of people     will also have clonidine added to their nerve block. This study will enroll 60 participants     from UAB hospitals.   "
99271|NCT01986738|"     This is a study to assess the motion of pancreatic tumors during radiation therapy using     Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.   "
99272|NCT01986725|"     In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom     distress and complications, which have an impact on a woman's quality of life and contribute     to high health care costs. For the majority of the patients, symptom and distress can be     reduced if adequate treatment is provided. This study aims to test possible differences     between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence in     women with vulvar neoplasia after surgical treatment.      In a sequential explanatory mixed-methods project, a randomized phase II study will be     followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated surgically     will participate in the randomized trial in four Swiss hospitals and one Austrian hospital.     After stratification by precancer/cancer, women will be randomly assigned (1:2 ratio) to     standardized care and the WOMAN-PRO II program. The standardized care group will receive a     set of information leaflets about supportive care options in the clinic. The WOMAN-PRO II     program group will obtain counseling sessions by specially trained gynecology-oncology nurse     specialists at the moment of diagnosis, 7 days post-surgery, in week two after discharge,     week twelve and week 24 after surgery. The primary outcome of this study is symptom     prevalence. Secondary outcomes will be collected for explorative reasons and include symptom     distress, uncertainty, quality of life, social support, resilience, quality of care,     sociodemographic and medical characteristics, post-surgical complications, functional status,     cost evaluation and process outcomes. Quantitative data will be collected at the counseling     points of time and analyzed by using mixed linear regression analysis. Twenty interviews will     be conducted with women of the WOMAN-PRO II program group. A focus-group interview will be     conducted with twelve gynecology-oncology nurse specialists in order to better understand to     which degree the interventions meet individual needs as well as to identify remaining     barriers and enablers for the implementation of symptom self-management. Qualitative data     will be analyzed by using thematic analysis and a critical hermeneutic reflection.      This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence,     patient-reported outcomes and clinical parameters, and inform the design of a possible phase     III study on the clinical efficacy of the program.   "
99273|NCT01986712|"     To evaluate the compliance with and perceptions of treatment, as well as health-related     quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN     therapy.   "
99274|NCT01986699|"     Study Objective: To compare the hospital costs between the standard surgical procedure and     the Laparascopic Assisted Colonoscopic Polypectomy (LACP) technique for patients with     advanced polyps in the colon.   "
99275|NCT01986686|"     Patients will agree to be randomized to either surgery or non-operative management following     a first episode of Hinchey II diverticulitis. Information will also be collected on rates of     recurrence rates and major complications in both groups.   "
99276|NCT01986673|"     The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is     absorbed and eliminated by the body, with and without the use of a condom, compared to a     single oral sildenafil dose and to evaluate the safety of sildenafil cream.   "
99277|NCT01986660|"     The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and     eliminated by the body under defined maximum dosing conditions and to evaluate the safety     under these conditions.   "
99278|NCT01986647|"     Community-dwelling older adults fear loss of independence and nursing home placement more     than death. Walking difficulty often leads to loss of independence. Exercise is beneficial to     physical and mental health and may prevent walking difficulty and promote independence.     Recognizing the importance of exercise, senior housing facilities offer exercise programs to     their residents. The exercise programs are often group-based, seated range of motion     exercises that do not challenge the older adult; consequently participation rates and     resident satisfaction are low.      If the goal is to improve walking to promote independence than the exercise program should     specifically target walking. Therefore, we developed a challenging, group exercise program     entitled On the Move which focuses on the fundamentals of walking. In this research study     we will determine if the On the Move program is better than a standard program at improving     walking and promoting independence and if the same benefits can be obtained if the On the     Move program is delivered by staff of the senior living facilities instead of an exercise     leader. To answer these questions, 400 community-dwelling older adults living in 32 different     Independent Living Facilities and Senior High Rises or living in the community and attending     senior community centers will be randomly assigned to either the 12 week On the Move group     exercise program or the standard group exercise program delivered by either an exercise     leader or staff activity personnel. Participants' walking and reported ability to carry out     everyday activities (functional ability) will be assessed before and after the 12 week     program. We will also assess participant safety and satisfaction with the exercise program     and instructor.      The findings from this research study will provide evidence for the value of the On the Move     group exercise program and will better inform patient choices regarding participation in     exercise programs. If successful in improving walking and promoting independence and     acceptable to the older adult, the On the Move program could be incorporated into exercise     programming for older adults in community centers, health clubs, and senior residences across     the country.   "
99290|NCT01986491|"     The purpose of the study is to compare the pharmacokinetics (what a medication does to the     body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose     oral administration of two solid oral formulations in Part 1; based on the profile in Part 1,     one of the formulations assessed will be selected to investigate the pharmacokinetics in     fasting condition in Part 2 and after repeated dosing in Part 3.   "
99291|NCT01986478|"     To collect data for a reference database.   "
99292|NCT01986465|"     The aim of this study is to evaluate the effectiveness of steroid injection and     immobilization versus no immobilization in treating patients with lateral epicondylitis.   "
99473|NCT01984099|"     A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of     postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.   "
99279|NCT01986634|"     Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be     addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable     scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing,     usually with laser treatment. Often the peri-oral area is treated with additional spot     treatments with an ablative laser to cause a more robust healing response and better aesthtic     result. To date, no studies have specifically shown efficacy of additional spot treatment     over full facial laser alone.      This study is designed as a split-face study, to compare the aesthetic results of full field     laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on     the other half.      To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is     used by many surgeons/laser proceduralists for addressing specific areas of the face. This is     an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and     enviromental factors that can effect the results the best design for the study to is have     each patient serve as their own control with a split-face study.   "
99280|NCT01986621|"     This pilot study aims to identify patients at moderate to high risk for peri-procedural (type     4) myocardial infarction or injury after after undergoing an elective coronary intervention     (PCI) as measured by high sensitivity troponin T, who might benefit from more potent     antiplatelet therapy.   "
99281|NCT01986608|"     This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a     single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral     dose of LCM 200 mg in healthy Japanese subjects.   "
99310|NCT01986231|"     The purpose of this study is to learn if giving multiple doses of a hormone called glucagon     can cause a major decrease in liver glycogen (animal starch). Glucagon is currently approved     by the Food and Drug Administration to be given as a large dose to treat severe low blood     sugar. Our group is studying whether glucagon can be given in repeated small doses to prevent     hypoglycemia.   "
99282|NCT01986595|"     Neuroblastoma (NB) originates from the sympathetic nervous system and is one of the most     common cancers in infants and children. In our hospital, nearly 70% of patients are diagnosed     with stage 4, metastatic disease with a poor prognosis, despite the use of multimodal therapy     including chemotherapy, surgery, autologous stem cell transplantation, radiation therapy, and     differentiation therapy. To improve the survival rate and patient care, our NB Study Group     has devoted to the research on NB-specific molecular imaging, biomarkers, and target therapy.     We have confirmed studies in cancer genetics by showing that N-myc gene (MYCN) amplification     and segmental abnormalities on overall genomic profiling both have an adverse effect on     treatment outcome. Therefore, there is an unmet need for the development of novel molecular     target therapy in NB. Recently, the anaplastic lymphoma kinase (ALK) oncogene has been found     to play an important role in the pathogenesis of NB, as well as serving as the driver     mutations in approximately 10% of high-risk NB. The availability of ALK inhibitors also     enables ALK as a treatment target in NB. In this proposal, we plan to utilize gene     sequencing, array-comparative hybridization, and multiplex ligation-dependent probe     amplification methods to evaluate the frequencies and characteristics of ALK mutations and     amplifications in patients with NB. The gene and protein expression of ALK will also be     evaluated by quantitative polymerase chain reaction(PCR) and immunohistochemistry,     respectively, and compared with ALK genotype. The overall genomic pattern, clinical     characteristics, histopathology, and treatment outcome of ALK-mutated NB patients will be     analyzed. The results from this study may serve as the first report on ALK mutations of NB in     Taiwan and will be used for the development of standardized genetic diagnosis protocols, as     well as the design of future clinical trials targeting ALK.   "
99283|NCT01986582|"     Allergic rhinitis is treated with a variety of systemic and locally applied drugs. The     effectiveness of the intranasally applied formulations is diminished by the cleaning     mechanisms of the nose, rhinorrhea in particular. Slowing down of the clearance of the nasal     mucosa and prolonging the contact time of locally applied drugs with the nasal mucosa would     improve their efficacy. One method is creating dosage forms containing mucoadhesive polymers.     We have demonstrated that a mucoadhesive solution containing HPMC enhances the clinical     efficacy of oxymetazoline. However, the industrial development of fixed combinations of     pharmaceutical compound and mucoadhesive carrier requires substantial investments, escalating     manifold if different pharmaceutical compounds have to be rendered mucoadhesive.      NoAl is a cellulose derivative powder, which forms a gel layer on contact with the mucosal     surface of the nose blocking the contact of the pollen grains with the nasal mucosa in     seasonal allergic rhinitis. However, there is another potential benefit of applying NoAl     (HPMC) along with other commercially available drugs for local treatment of rhinitis, as the     formation of a gel layer can substantially delay their clearance from the nose and thus     increase their effectiveness. This hypothesis needs to be substantiated clinically.   "
99284|NCT01986569|"     The standard diagnostic workup for recurrent or metastatic breast cancer includes biopsy and     determination of tumor estrogen status according to National Comprehensive Cancer Network and     European Society for Medical Oncology. Immunohistochemistry (IHC) is currently the most     commonly used method for determining ER status. A investigational imaging tracer named     16-alpha-[18F]-fluoro-17-beta-estradiol, or [18F]fluoroestradiol ([18F]FES) acts similarly in     vivo to estradiol and binds to estrogen receptors (ERs). Previous studies in human have shown     the efficacy of [18F]FES PET in detecting ER positive breast cancer without any observed     toxicity. The investigators hypothesized that [18F]FES PET imaging can noninvasively assess     ER status in recurrent or metastatic breast cancer lesion . In this study, a positive and     negative percent agreement between IHC and [18F]FES will be determined.   "
99285|NCT01986556|"     This study will assess the relative bioavailability of lesinurad tablets, manufactured at two     different sites.   "
99286|NCT01986543|"     We propose a first interaction study between efavirenz (EFV) and R20mg/Kg taking into     consideration the absence of data about R induction at this dose. Due to an important     inter-patient variability of the CYP2B6 polymorphism, the EFV pharmacokinetic (Pk) will be     compared in same patients with and without TB treatment.      The main objective is to compare the Pk parameters of EFV in HIV-TB co-infected patients,     with and without TB treatment, using R at 10 and 20mg/Kg/day and EFV at 600 and 800mg/day.   "
99287|NCT01986530|"     Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating     adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the     role of circulating irisin in healthy individuals in correlation with lean and fat body mass.     Furthermore, the circadian and seasonal variation of irisin is largely unknown.   "
99288|NCT01986517|"     The purpose of the current study is to examine the influence of feedback on psychotherapeutic     competency. The present randomized controlled study compares a feedback condition with a     non-feedback condition. Therapists in the feedback condition receive feedback after every     fourth session. The feedback is given by two trained and independent raters. The raters are     licenced and experienced psychotherapists. Therapists in the non-feedback condition receive     no feedback during the psychotherapy.   "
100334|NCT01972841|"     The purpose of this study is to examine how well two medicines (solifenacin succinate and     mirabegron) combined work compared to each medicine alone in the treatment of bladder     problems.   "
99296|NCT01986413|"     Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with     pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep     quality and alveolar ventilation in patients with routine NIV initiation after COPD     exacerbation.      20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on     NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one     with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will     spend the treatment nights in randomized order under polysomnographic surveillance, including     transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night     the sleep quality will be judged with regards to especially adjusted respiratory event     criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory     drive.   "
99297|NCT01986400|"     Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes     and quality of life in adolescents with Juvenile Idiopathic Arthritis   "
99298|NCT01986387|"     Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes     and quality of life in adolescents with chronic pain.   "
99299|NCT01986374|"     The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest     that placing HCG into the uterus prior to embryo transfer can enhance implantation.   "
99300|NCT01986361|"     The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain     relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the     Double-Stopwatch Method (DSW).   "
99312|NCT01986205|"     The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on     long-term symptoms after concussion. This study will enroll 90 individuals with persistent     problems 1-5 years after a mild traumatic brain injury. These individuals will be randomized     to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will     receive 40 daily hyperbaric chamber sessions.      Participants will have a series of tests and questionnaires before they begin their chamber     sessions, after they complete 40 sessions, and 12 months after they joined the study. These     tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain     imaging, a neurological examination, and an eye exam. Participants will also be asked to     provide blood for future research.   "
99313|NCT01986192|"     The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for     prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis     patients and FDA approved the rivaroxaban for prevention and treatment of deep vein     thrombosis (Nov 2 2012).      Recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome,     and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e,     iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis     if they had been treated with a vena cava filter or a fibrinolytic agent for the current     episode of thrombosis.      Although catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now been     accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk of     bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24     hours after thrombolysis will be included in this study.      Also, the investigators want to explore the efficacy and safety of rivaroxaban in patients     with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter insertion     and/or venous stent insertion and compare these outcomes with warfarin treatment alone.      This study will be a pilot study to establish the safety and efficacy parameters for further     studies.   "
99373|NCT01985412|"     The purpose of this study is to determine whether shotgun sequencing technology, which can be     used to detect donor DNA in recipient plasma, can be used as a rapid, accurate, non-invasive     method to detect Acute Cellular Rejection (ACR) after heart transplantation. Currently, all     heart transplant recipients undergo invasive heart biopsies to diagnose ACR. Thus, there is     an ongoing need to monitor patients for the development of acute and chronic rejection, with     the primary goal of non-invasive early detection and treatment to prevent organ damage.   "
99314|NCT01986179|"     Professional interpretation improves quality of care for patients with limited English     proficiency (LEP). However, many health care settings lack access to professional     interpreters, and even in locations with good access, logistical factors and perceived     barriers have limited their widespread use. Remote methods of professional interpretation,     including telephone and video, hold great promise for expanding access, but only limited data     exist on the relative impacts of these modalities on patient care and provider uptake.     Comparing how these modalities impact multiple aspects of health care quality, including     family comprehension, provider communication, and consistency of provider interpreter use     will inform dissemination of strategies for delivery of safe, efficient, and equitable care     to LEP families.      Aim 1: To determine whether randomly assigned remote interpreter modality (telephone versus     video) impacts parent-reported quality of communication and interpretation, diagnosis     comprehension, and length of stay (LOS) among LEP Spanish-speaking families seen in a     pediatric Emergency Department (ED).      Hypothesis 1: Parent-reported quality of communication and interpretation and parent     diagnosis comprehension will be higher among families assigned to video interpretation     compared to telephone interpretation.      Hypothesis 2: LOS will not differ between families assigned to video and telephone     interpretation.      Aim 2: To determine whether assigned interpreter modality is associated with provider     decision to communicate without professional interpretation.      Hypothesis 3: Parent-reported provider communication without professional interpretation     (e.g. using the patient or a family member to interpret for some part of the visit) will be     lower for families assigned to video interpretation compared to telephone interpretation.   "
99315|NCT01986166|"     This open-label, multicenter, global Phase Ib study will evaluate the safety, tolerability     and pharmacokinetics of intravenous (IV) dosing of MEHD7945A in combination with oral dosing     of cobimetinib in patients with locally advanced or metastatic solid tumors that carry a     Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation and for which standard therapies     do not exist, have proven ineffective or intolerable or are considered inappropriate. The     study comprises a dose-escalation (Stage 1) and an indication-specific cohort expansion stage     (Stage 2).   "
99316|NCT01986153|"     The purpose of this study is to determine if patients on long-term olive oil-based parenteral     nutrition have an adequate essential fatty acid status and immune status, compared to age-     and sex-matched healthy controls.   "
99317|NCT01986140|"     Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing     chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant     chemotherapy.   "
99318|NCT01986127|"     We study if the administration of intralesional Adalimumab (directly injected in the     stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared     with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3     stenosis as maximum)   "
99319|NCT01986114|"     The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I     disorder.   "
99320|NCT01986101|"     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients     with Bipolar I Depression.   "
99321|NCT01986088|"     A previously published, placebo-controlled, head-to-head comparator study found eletriptan to     have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack.     The goal of the current study was to extend the findings of that study by examining the     efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to     evaluate the comparative efficacy of eletriptan and sumatriptan across additional important     clinical outcomes. In particular, early response (at 1 hour), sustained response (without     need for additional treatment) at 24 hours, and consistency of response across multiple     attacks were examined.   "
99322|NCT01986075|"     This study will investigate a treatment strategy in which a computer-assisted behavioral     intervention will be used to help individuals stop their use of cocaine. A medication will be     combined with the behavioral treatment among those individuals who do not respond to the     behavioral intervention alone. The primary hypothesis of the study is that among cocaine     dependent individuals who fail to respond to an initial trial of behavioral therapy, a     greater proportion of individuals will benefit from the combined treatment (behavior therapy     plus medication) compared to individuals in the comparison group.   "
100053|NCT01976520|"     This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients     with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containing an     extract of a person's cancer cells and the immunostimulant interleukin-2 may help the body to     build an effective immune response to kill cancer cells.   "
99323|NCT01986062|"     This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in     approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will     enroll in the study to take open-label AR11 twice daily and undergo dose optimization     activities for 8 weeks. Patients who achieve a stable dose during the dose optimization     period will continue participation and will be randomized to take double-blind medication     (AR11 or placebo) orally twice daily for 1 week. At the end of the first double-blind     treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom     setting utilizing SKAMP and PERMP assessments. At the end of the second double blind     treatment period, patients will be evaluated for ADHD symptoms in a second laboratory     classroom setting utilizing SKAMP and PERMP assessments.   "
99324|NCT01986049|"     Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean     section for pain relief.   "
99325|NCT01986036|"     High-protein meals have previously been shown to acutely reduce appetite and energy intake.     More recently, meals higher in calcium have also been shown to increase feelings of fullness,     circulating insulin and intestinal peptide concentrations and reduce appetite sensations.      This study aims to assess whether calcium and protein act synergistically to acutely     influence appetite and energy intake.   "
99326|NCT01986023|"     The impact of medications used for secondary stroke prevention relies heavily upon patient     adherence. Adherence is defined as the extent to which a person's behavior - taking     medication, following a diet, and/or executing lifestyle changes, corresponds with agreed     recommendations from a health care provider. It is said that optimal adherence to     medications may reduce the risk of a poor outcome by 26%.      The purpose of this study which is a non-pharmacologic behavioral study is to encourage     adherence to medications in stroke survivors by tailored and specific SMS reminders. (Short     Text Messages). These SMS reminders will support and assist stroke patients to take     medications as prescribed and on time. We hypothesise that SMS will improve the adherence of     patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.   "
99327|NCT01986010|"     This study will evaluate the safety, tolerability, and immunogenicity of various doses,     formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160     administered in a 3-dose regimen in healthy adults. Each treatment arm of 10 participants     will be accompanied by a placebo arm of 4 participants. The initial treatment arm of HCMV     seropositive participants will receive V160 Low Dose without adjuvant by intramuscular     injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal     injection, and vaccination of HCMV seronegative participants will be performed only after     review of safety data of previous treatment arms. The purpose of the study is to identify     vaccine formulations associated with optimal safety profile and HCMV-specific immune response     for evaluation in subsequent clinical studies of V160.   "
99329|NCT01985984|"     The primary and general objective of the clinical introduction of the Standard Follow-up     Program (SFP) as the current standard of care is to improve the quality of radiotherapy for     head and neck cancer patients by reducing radiation-induced side effects without hampering     treatment efficacy in terms of locoregional tumour control and overall survival and to     systematically evaluate the beneficial effect of newly introduced radiation technology for     this particular group of patients. The clinical introduction of the SFP will allow for a     systematic and broad scale quality improvement cycle for head and neck cancer patients     treated with radiotherapy. In fact, this methodology can be considered a kind of quality     circle for the clinical introduction of new radiation techniques, aiming at continuous     efforts for further improvement.   "
99330|NCT01985971|"     To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with     brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.   "
99331|NCT01985958|"     Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic     lesion produces an immune response in patients with metastatic carcinoma of the pancreas.      Secondary Objectives: To characterize the kinetics of an immune response induced by     radiotherapy. To characterize the dependency of the immune response on prior exposure to     chemotherapy.   "
99332|NCT01985945|"     The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of     20 women with stage I and II breast cancer receiving radiation therapy treatment, while a     second cohort of the same type of and number of patients who, instead of yoga will receive     standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G     instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several     points.   "
99333|NCT01985932|"     This study is being done to evaluate the use of MRI during radiation treatment planning to     identify areas of tumor within the prostate to aid in future treatment planning and targeting     of prostate cancer. This study will be conducted at the University of Pennsylvania Health     System. The study is projected to run for 18 months. Subjects will be male 18 or older with a     prostate cancer diagnosis and treatment plansat the Department of Radiation Oncology.   "
99334|NCT01985919|"     This clinical research protocol is intended to allow for bone marrow aspirate/biopsy and     blood specimens to be collected for research purposes, specifically allowing subjects the     option of sedation during the bone marrow procedure. Samples will be banked for future     research related to cancer and other diseases. Researchers hope this protocol will improve     the collection of research correlative and translational biopsy specimens for clinical     research.   "
99335|NCT01985906|"     Complex aortic aneurysms involving major branches have been difficult endovascularly. The     primary purposes of this study is to evaluate the safety, feasibility, and efficacy of     multiple overlapping uncovered stents in treating aortic aneurysm while preserving major     visceral branches, including the celiac artery (CA), superior mesenteric artery (SMA) and     renal artery (RA).   "
99336|NCT01985893|"     The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab     compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free     survival, tumour response and overall survival.   "
99337|NCT01985880|"     The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial     cystitis/painful bladder syndrome   "
99338|NCT01985867|"     The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35     administration for the treatment of functional constipation in children.   "
99339|NCT01985854|"     Since neurological testing during neurosurgery, such as somato-sensory evoked potentials,     motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well     maintained their wave-form reactivity with total intravenous anaesthesia technique better     than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is     usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the     evoked potential responses during surgery, facilitation of recovery from general anesthesia     is getting important, because the real neurological physical examination is much more     sensitive than above electrical evoked potentials to evaluate the results of surgical     operation.      We propose to evaluate the recovery parameters after conversion from total intravenous     anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The     conversion will be initiated upon completion of the neurophysiological electric evoked     potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize     that recovery after conversion to Desflurane will be faster compared to recovery after total     intravenous anaesthesia alone.   "
99340|NCT01985841|"     Investigators propose to study the efficacy of Bevacizumab plus systemic chemotherapy prior     to surgery in order to make a locally advanced tumor operable. Treatment is thus expected to     induce a maximum tumor shrinkage within a short period (usually 3-6 months). In addition     Bevacizumab (Avastin) is to be administered as early as possible during the disease stages.     The primary aim of this study is to evaluate the preliminary antitumor activity in terms of     pathological complete responses (pCR) of bevacizumab in combination with chemotherapy.   "
99358|NCT01985607|"     Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting     are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive     hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and     Nutrition (NASPGHAN) & the European Society of Pediatric Gastroenterology Hepatology and     Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of     distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to     thicken an extensive hydrolysate .      This study aims at evaluating the additional value of a thickened extensive hydrolysate in     children suspected of CMA and presenting with frequent regurgitation.   "
99359|NCT01985594|"     RESEARCH HYPOTHESIS      -Incidence of preterm delivery is lower in women treated with oral micronized progesterone     (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side     effect   "
99374|NCT01985399|"     Investigators hypothesize that older HIV-infected individuals (i.e., >50 years old) on     efavirenz (EFV)-containing antiretroviral therapy (ART) will have significantly worse     neurocognitive function than older individuals on non-EFV-containing ART.   "
101998|NCT01951027|"     pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in     healthy male subjects.   "
99341|NCT01985828|"     The primary objective of this study is to document the effectiveness of Cyberknife     stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk     localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix     and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.      During the prostate-specific antigen era, an ever-increasing percentage of men with prostate     cancer have presented with clinically localized, potentially curable disease. Although     conventional treatment options are potentially curative in selected patients, these     treatments also have drawbacks, including the risk of negative long-term quality of life     consequences and serious complications.      The CyberKnife® system is a type of radiation machine that uses a special system to precisely     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be     minimal.      Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body     Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity     Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT     boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL     questionnaires before treatment. Questionnaires will also be completed during follow-up     visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.   "
99342|NCT01985815|"     In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain     Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes     are implanted within specific sub-structures of the brain in order to modulate the activity     in targeted neural circuits associated with different neurological disorders. The results of     this novel approach to psychiatric disorders have been optimistic. This study aims to     investigate wether or not the distance to target location has an influence on the outcome.      In order to deliver DBS, leads containing four electrodes are implanted into the brain target     in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter     a triple blind randomised two fazed crossover design of two periods of three months. In both     crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the     stimulation conditions. These conditions are stimulation ON (at optimal parameters) and     stimulation OFF. Stimulation parameters are constant during the entire period. During the     second crossover branch, stimulation conditions are reversed for all patients.   "
99350|NCT01985711|"     The goal of this proposal is to integrate depression services and diabetes care methods into     a web-based collaborative care system so that a single program can assist patients with     diabetes and co-morbid depression. The investigators hypothesized that the effect of the     intervention program on (a) decreasing depressive symptomatology; (b) improving biomedical     outcomes (e.g., blood lipid profiles,blood glucose, glycosylated hemoglobin, and blood     pressure). (c) Increasing healthful behavior (medicine compliance, physical activity,     diabetic diet);(d)decreasing unhealthful behavior( sedentary activities, smoking, alcohol     addiction); (e) improving quality of life.   "
99351|NCT01985698|"     In this study, the investigators assessed the difference in efficacy and safety among     robotic-assisted versus laparoscopic versus open abdominoperineal resection for patients with     low rectal cancer.   "
100054|NCT01976507|"     The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic     event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of     dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency     ablation, or cryoablation procedures.   "
99343|NCT01985802|"     The purpose of this study is to explore if there is a less harmful way to pace patients with     first-degree AV-block to ensure that the negative effects inferred by the pacing do not     outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that     His-bundle pacing will offer a more physiological mode of pacing in patients with     first-degree AV-block than conventional pacing.      Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with     first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular     ejection fraction will be included. During the AF ablation three different pacing modes     (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the     basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the     completion of all six pacing protocols (i.e., three modes at two different rates) the     experimental part of the procedure ends.      The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary     end-points will include left ventricular ejection fraction, left ventricular volume, mitral     regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay.     Since the research study is conducted in parallel with the standard catheter ablation, we do     not anticipate any additional side effects as a result of the study.   "
99344|NCT01985789|"     The asthmatic airway is identified and studied using inhaled agents such as histamine and     methacholine. The use of antihistamines prior to the test will inhibit the test result if     histamine is used to cause airway constriction. If using methacholine, this may also be true     depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used.     This study will look at the effect of old and new antihistamines on inhaled methacholine     challenge response in individuals with mild asthma.   "
99345|NCT01985776|"     The first purpose of this study is to define parameters of the trunk neuromuscular functions     that are pathologically altered in patients with low back pain due to spondylolytic     spondylolisthesis. The second and also the main purpose of the study is to examine the     effects of exercise intervention on patients with low back pain due to spondylolytic     spondylolisthesis. Our overall hypothesis is that specific exercise intervention will improve     neuromuscular functions of the trunk in patients with low back pain due to spondylolytic     spondylolisthesis.   "
99346|NCT01985763|"     Colorectal neoplasms are the third most common malignancies in the United States. Patients     with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The     response rates to chemotherapy range from 35-40%.      Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal     cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit     Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations     also demonstrate that genistein may augment growth inhibition when combined with     chemotherapeutic agents of 5-Fluorouracil and platinum compounds.      Based on pre-clinical data the investigators hypothesize that combining genistein with the     standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve     response rates in patients. The aim of the study is to add genistein to the regimens of     FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.   "
99360|NCT01985581|"     This study looks to examine whether or not INTUNIV extended release can help children aged     6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving     Executive Function when added to their usual care stimulant therapy. Executive functions are     a set of mental processes that include emotional control, planning, organization, working     memory, inhibition of behaviors, and managing time and space. As children with ADHD usually     have difficulties with Executive Function, and Executive function difficulties lead to more     difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release     to usual stimulant therapy will improve Executive Function scores as rated by parents and     teachers. Improvements in quality of life will also be measured.   "
101050|NCT01963455|"     This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for     the treatment of stress urine incontinency (SUI) in women.   "
99347|NCT01985750|"     Dyspnoea is the uncomfortable shortness of breath that debilitates millions of patients with     lung disease, heart failure and cancer. It is often very difficult to treat. The sensations     of dyspnoea are processed in the brain, and we believe that psychological factors modify and     amplify these sensations, frequently exacerbating symptoms.      This study aims to identify the importance of learning in the brain mechanisms of dyspnoea by     investigating a cohort of patients with chronic breathlessness undergoing pulmonary     rehabilitation . Pulmonary rehabilitation is a six-week course of exercise, education and     group therapy that improves dyspnoea but does not improve lung function. This leads us to     hypothesise that some of the beneficial effects of PR maybe due to changes in brain     processing, potentially relating to a learning effect.      Therefore to probe whether learning is important in the beneficial effects of pulmonary     rehabilitation, we intend to modify learning with the drug d-cycloserine. D-cycloserine is an     antibiotic that enhances learning due to its effects at N-methyl D-aspartate (NMDA) receptors     in the hippocampus. Our previous study in a similar group of patients demonstrated the     importance of the hippocampus in breathlessness perception, and we now wish to investigate     this in more depth.      The study involves collecting physiological, psychological and clinical measures on in     conjunction with brain scanning, before, during and once after pulmonary rehabilitation.     Subjects will either receive d-cyloserine or placebo before the first four pulmonary     rehabilitation sessions.   "
99348|NCT01985737|"     Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into     blood vessels of premature babies (neonates) to give them nutrition and medications.     Sometimes these tubes get infected and they need to be removed. Also, the babies need to be     given medications to treat these infections (antibiotics). PICC infections in neonates are a     serious problem and we need to find new ways of detecting infections early so that we can     treat them promptly to avoid complications.      The purpose of this study is to understand what causes tube infections in neonates and to     develop a test to detect tube infections early to avoid complications.   "
99349|NCT01985724|"     In this trial investigators propose to assess the dose dense, G-CSF supported sequential     administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of     docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary     lymph node positive breast cancer   "
100055|NCT01976494|"     Acute post-operative pain causes not only discomfort for the patient, but delays recovery by     increasing the morbidity of the circulatory system, respiratory system, and immune system, so     pain control is one of the important objectives in peri-operative patient management. Patient     controlled analgesia (PCA) is a piece of equipment for which the patient can personally     control the administration of an analgesic. It is generally used in postoperative pain     management because it is a method which can heighten patient satisfaction by reducing     complications and obtaining the appropriate level of pain relief. Usually, it is designed to     administer an analgesic at a steady speed, and the patient can administer additional     medication by pressing a button when the pain is severe. Here, to prevent complications from     excessive administration of an analgesic, repeated administration is not allowed within a     certain time interval. The PCA equipment can be categorized as electronic and physical     according to the force which operates the drug injection pump. Electronic equipment uses     electrical energy to apply vermicular movement to the fluid tube to administer the analgesic.     Physical equipment is disposable equipment designed to fill an elastomer reservoir bag     expanding the material, and its elasticity returns to the original length used to administer     the analgesic. The physical equipment is easy to carry and movement is comfortable because     there is no need for additional electronic equipment or devices. There is also no need for     special training to operate the equipment, and the action mechanism is simple so there is     less opportunity for malfunction. The disposable physical equipment accounts for     approximately 70% of the domestic market share and it is preferred over the electronic     equipment. On the other hand, contrary to the electronic equipment, the physical PCA     equipment has the disadvantage of not providing information regarding the history of the     equipment's use. The early physical PCA equipment was very simple and only had the function     of continually administering medication at a set speed. Hence, it was not sufficient to     function as 'patient controlled' pain control equipment. Then, the function of an additional     administration button was added so that the patient can personally decide whether to     administer an additional amount of analgesic. At the same time, the physical PCA equipment     has improved to prevent excessive administration by setting a lock-out time as a safety     measure. The following development was Accufuser Selectuss®, where a function was added to     select the administration speed from three options. In this way, the physical PCA equipment     has continued to evolve in the direction of enhancing safety, convenience, and clinical     effectiveness. The advantage of pain control using PCA equipment is that the patient can     personally control additional the administration of an analgesic by pressing a button. In the     case of existing or imported products, it is designed to administer a bolus by pressing the     button, and the pressure presses the PVC bag filled with medication under the button to     administer the bolus. Compared to the intravenous route, using an epidural as a PCA     administration route has superior analgesic effect, so it can reduce the amount of opioid     analgesic administered. On the other hand, the disadvantage is that it has to pass through a     narrow and long epidural catheter to deliver the medication to the epidural space which has a     relatively higher resistance. Woo Young Medical experimented with their own product Accufuser     plus® (Woo Young Medical, Korea), and the results showed that the time taken to empty the     bolus bag was approximately 40-80 seconds depending on the dosage. The pressure when a person     presses the bolus button on the PCA equipment was repeatedly measured to obtain a mean value,     and this pressure was constantly maintained by a machine to measure the time taken to empty     the bolus bag. Clinically, it is not easy to continually press the button for 40-80 seconds,     so it is difficult to exclude the possibility that the bolus was not administered properly.     In addition, when excessive pressure is applied, there is the possibility that the bolus bag     may burst. The domestically developed products and Accufuser Omnibus® (Woo Young Medical,     Korea) was developed for the purpose of supplementing bolus failure which can occur when     using epidural PCA. Within the bolus module, a second elastomeric balloon is installed behind     the first bolus bag so the patient does not have to press the bolus button for a long time.      Therefore, this research focused on the effectiveness and safety of the domestic product     Accufuser Omnibus® (Woo Young Medical, Korea) regarding whether the bolus is sufficiently     delivered when it is administered through the epidural route, and compared the results     through a comparative clinical trial with imported physical PCA equipment (Infusor SV®,     Baxter, USA).   "
99352|NCT01985685|"     The objective of this study is to determine the effect of thiamine therapy on oxygen     consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before     and after thiamine or placebo administration in patients admitted to the ICU and requiring     mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on     the metabolic profile of the patients.   "
99353|NCT01985672|"     Vitamin D receptors are present and differently expressed in murine endometrium and ovary     throughout the estrous cycle , whereas knock-out experiments have shown that vitamin D     receptor null mice experience uterine hypoplasia and impaired folliculogenesis.      Only few retrospective studies examining the role of vitamin D levels in infertile patients     have been published up to date, whereas results are strongly contradictory, with some     supporting that maternal vitamin D deficiency is associated with lower pregnancy rates and     others demonstrating that vitamin D deficiency does not affect final reproductive outcome.      Finally, a recent retrospective study postulated that vitamin D deficiency may negatively     affect pregnancy rates with an effect mediated through the endometrium, given that vitamin D     deficiency was not correlated with ovarian stimulation characteristics or with markers of     embryo quality in this study.      In order to examine a potential negative effect of vitamin D deficiency on pregnancy rates,     mediated through the endometrium, the aim of the current study was to examine the impact of     vitamin D levels on pregnancy rates only in an infertile population undergoing embryo     transfer of frozen-thawed embryos.   "
99354|NCT01985659|"     This study investigates peropeative nodal upstaging during anatomical resections for     non-small-cell-lung-cancer in an era of rising numbers of VATS anatomical resections. In case     of comparable study groups, unchanged pretreatment staging and equal quality of pathologic     examination, lymph node upstaging is a marker of surgical quality and can be used to study     the quality of a new surgical technique.   "
99355|NCT01985646|"     The present study was designed to compare the efficacy of conservative treatment to operative     treatment for improvement of constipation symptoms in infants with short or normal-segment     Hirschsprung disease.   "
99356|NCT01985633|"     Osteoarthritis (OA) is one of the most common joint diseases.This disease commonly develops     in the weight bearing joints of the lower limbs, such as the knee and hip joints.     Osteoarthritis is considered a chronic degenerative disorder that is characterized by a loss     of articular cartilage. Pathogenesis can involve all of the major articular tissues including     cartilage, synovial membrane, subchondral bone and other connective tissues such as ligaments     and tendons3. There is no effective therapy available today that alters the pathobiologic     course of the disease.In view of vast role of platelet derived growth factors, mesenchymal     cells and its safety, this prospective clinical trial is designed in an attempt to compare     the efficacy of mesenchymal stem cells enhanced with platelet rich plasma in early stages of     knee osteoarthritis.   "
99357|NCT01985620|"     Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination     rate against influenza are low in spite of national programs. Study goal is to evaluate the     effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents     about the importance of influenza vaccination.   "
105223|NCT01908816|"     The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare     VEGF driven ocular diseases.   "
99361|NCT01985568|"     The primary aim of this study is to evaluate the extent to which an exercise intervention     timed after diet-induced weight loss (rather than initiated at the same time) improves     exercise adherence and long-term weight loss. An 18 month randomized trial will be used to     compare two behavioral weight loss programs; standard behavioral therapy (Standard BT) and     sequential behavioral therapy (Sequential BT). The Standard BT group will receive a     traditional behavioral weight loss program where diet and exercise changes are initiated at     the same time. The Sequential BT group will receive a program that focuses solely on dietary     changes in the initial 6 months, and then incorporates exercise in the ensuing 6 months. Both     groups will be followed for 18 months to assess long-term weight loss. The hypothesis is that     delivery of diet and exercise interventions in sequence will result in improved adherence to     exercise and weight loss at 18 months when compared to a traditional program in which     identical diet and exercise interventions are initiated at the same time. This study could     identify a strategy that could aid in the development of more effective obesity treatment     programs and help more people achieve and sustain a weight loss.   "
99362|NCT01985555|"     The purpose of this study is to evaluate the safety and tolerability of single and multiple     doses of volitinib administered to patients with locally advanced or metastatic solid tumors     and determine MTD (Maximum Tolerated Dose) or RPTD(recommended Phase 2 dose).   "
99363|NCT01985542|"     Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and     other environmental insults. About 20 % of the European population suffers from pollen     allergies. Birch pollen allergic rhinitis is the most common allergic disease in the     Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of     pollen allergies may be reduced by understanding the molecular biology of the nasal barriers     during allergic response. Our aim is to observe the effect of season and birch pollen     immunotherapy on the molecular biology of nasal epithelium and the microbiome.   "
99364|NCT01985529|"     The effectiveness of clinic-based pulmonary rehabilitation in advanced Chronic Obstructive     Pulmonary Disease (COPD) is well established, but few data exist for less severe patients     treated in alternative settings. The purpose of this study was to investigate whether a     novel, community-based exercise program was feasible and effective for patients with moderate     COPD.   "
99365|NCT01985516|"     Currently, there are no specific guidelines or best practice suggestions for female     catheterization. However, there is a consensus that an anesthetic lubricating gel should be     routinely used in women as well.      Urethral lubrication can be performed in two different techniques: instillation of the gel     directly into the urethra or pouring the gel on the catheter's tip. In this study, we will     evaluate the pain level during female urethral catheterization in each technique.      Our hypothesis is that the level of pain will be much less if the lubrication agent will be     instilled directely to the urethra.   "
99398|NCT01985087|"     In this study we propose to determine outcomes of patients age 70 or older treated with     radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a     post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease     progresses.   "
99366|NCT01985503|"     In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose     tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT     started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current     study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up     study to examine associations between obesity, cardiovascular risk factors, serum metabolic     profile and BAT structure at baseline and during follow-up several years later. 43 BATPET     participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52     FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years.     The aim of this study is to examine longitudinal associations between BAT function and     structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.   "
99367|NCT01985490|"     Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be     visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting     membrane is frequently performed procedure and we suspected that these procedures may affect     integrity of foveal avascular zone.      The purpose of the present study is to evaluate the change of foveal avascular zone after     removal of epiretinal membrane and internal limiting membrane   "
99368|NCT01985477|"     The goal of the Phase I portion of this clinical research study is to find the highest     tolerated dose of the combination of lenalidomide, all-trans retinoic acid (ATRA), and     dexamethasone that can be given to patients with relapsed or refractory multiple myeloma     (MM).      The goal of the Phase II portion of this study is to learn if ATRA when given in combination     with lenalidomide alone or with lenalidomide and dexamethasone can help to control multiple     myeloma.      In September 2015, the study was terminated due to slow accrual while still a Phase I study,     no additional registration or research performed under the Phase II portion of the study.   "
99369|NCT01985464|"     Allogeneic human umbilical cord tissue-derived stem cells will be injected intravenously once     per day for 5 days is a safe and useful procedure in inducing remission of RA in patients     resistant to standard DMARD therapy.   "
99370|NCT01985451|"     In this trial, we will treat relapsed PCNSL with temozolomide, pemetrexed. Our objective was     to assess our treatment strategies' availability based on response rates, progression-free     survival (PFS), median PFS, and toxicity.   "
99371|NCT01985438|"     Purpose:      To compare the effect of prophylactic enteral feeding tube placement (either percutaneous     endoscopic gastrostomy (PEG) tube or nasogastric (NG) tube) in patients undergoing treatment     for head and neck cancer (HNC) on nutritional status, quality of life, mental and emotional     health, rates of clinical complications, and cost of care.      Study Design:      Prospective randomized controlled trial with 2 arms and equal allocation ratio      Study Objectives:        1. The primary objective is to assess, among HNC patients randomized to receive either          prophylactic PEG tube or NG tube for enteral support and who are undergoing          chemo-radiation at SKMCH&RC, the change from baseline in nutritional status at the end          of 24 weeks after treatment initiation.        2. The secondary objectives are to assess, among HNC patients randomized to receive either          prophylactic PEG tube or NG tube for enteral support and who are undergoing          chemo-radiation at SKMCH&RC, the change from baseline in nutritional status at the end          of 12 weeks; the rates of complications; quality of life including symptoms of          depression and anxiety; and cost of care (all related to enteral feeding tube placement          only) at baseline and at the end of 12 weeks and 24 weeks after treatment initiation.      Patients and methods:      Eligible patients will be enrolled consecutively from the gastroenterology outpatient clinics     at Shaukat Khanum Memorial Cancer Hospital and Research Center (SKMCH&RC), Lahore and     randomly assigned to receive either PEG tube or NG tube placement prior to commencement of     treatment. Patients will receive counseling from a trained nutritionist regarding adequate     nutrition during treatment and enteral feeding tube care. Detailed information regarding     demographics, cancer location, type and staging, clinical status, nutritional status, quality     of life, mental and emotional health, and cost of care will be obtained at baseline (time at     which cancer treatment is initiated) and on 21st day (3 weeks), 42nd day (6 weeks), 84th day     (12 weeks) and 168th day (24 weeks) after initiating chemoradiation. The primary endpoint     will be to compare the nutritional status between the two treatment groups on an     intent-to-treat basis on 168th day (24 weeks) after initiating chemoradiation.   "
99375|NCT01985386|"     Slow release iron capsules containing ferrous sulfate have been designed based on the gastric     delivery system. Iron absorption from those capsules administered with and without meals will     be measured using stable iron isotopes.   "
99376|NCT01985373|"     Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune     related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed     a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam     50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml     (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of     Sanquin.   "
99377|NCT01985360|"     The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for     patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced     chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis).     This is a multicenter randomized controlled trial with a target randomization of ~1000     patients with advanced CKD and at least moderate ischemia on stress testing. Participants     will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization     (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative     strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. The     trial is designed to run seamlessly in parallel to the main ISCHEMIA trial as a companion     ancillary trial.      SPECIFIC AIMS      A. Primary Aim. The primary aim of the ISCHEMIA-CKD trial is to determine whether an invasive     strategy of routine early catheterization followed by optimal revascularization, in addition     to OMT, will reduce the primary composite endpoint of death or nonfatal myocardial infarction     in SIHD patients with advanced CKD and at least moderate ischemia over an average follow-up     of approximately 4 years compared with an initial conservative strategy of OMT alone with     catheterization reserved for those who fail OMT. The primary endpoint is time to centrally     adjudicated death or nonfatal myocardial infarction (MI).      B. Secondary Aims. Major: To compare angina-related quality of life between the INV and CON     strategies. Other secondary aims include: comparing the incidence of the composite of     cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or     hospitalization for unstable angina or heart failure; composite of cardiovascular death or     nonfatal myocardial infarction; cardiovascular death; non-fatal myocardial infarction;     all-cause death; stroke; hospitalization for heart failure or unstable angina      Condition: Coronary Disease Procedure: Cardiac catheterization Phase: Phase III Condition:     Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other     catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary     Artery Bypass Surgery Phase: Phase III   "
99399|NCT01985074|"     The aim of the study is to determine whether a nurse-managed telephone-based case-management     intervention can reduce healthcare utilization and improve self-assessed health status in     frequent emergency department users.   "
99418|NCT01984827|"     High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have     both been shown independently to affect heart activity in healthy volunteers as recorded by     ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the time between     the start of the Qwave and the end of the Twave during a heartbeat cycle. In this study, the     investigators want to find out whether moxifloxacin and hyperglycaemia cause QTc prolongation     in Type 1 diabetic patients. The investigators also want to assess whether C-peptide (a     fragment if insulin normally found in the blood but not present in not present in the blood     of Type 1 diabetics) which has the opposite effect on heart activity i.e it shortens the QTc     interval will reverse the effect of QTc prolongation in Type 1 diabetes as this may be useful     for preventing 'dead in bed' syndrome also known as 'Sudden Cardiac Death' which is more     common in diabetic patients compared to healthy volunteers.   "
99419|NCT01984814|"     The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic     Lateral Sclerosis patients.   "
99378|NCT01985347|"     The prevalence of anxiety and depression in our OSA population is more than in COPD and the     general population of North West Adelaide. (principal hypothesis).      CPAP therapy in OSA population produces a positive effect on the anxiety and depression     scale.      The Investigators intend to study the prevalence of anxiety and depression in patients with     sleep disorders in comparison to patients with COPD and subsequently, to assess whether CPAP     has a role in controlling anxiety and depression in depressed and anxious patients with sleep     apnoea.      This is a two phase study, in first phase; investigator will assess the prevalence of anxiety     and depression, in a population with sleep disorders to check whether it is different to the     prevalence in the COPD population. The prevalence of depression in Sleep Disorder population     will also be compared with the Adelaide North Western general population, which was reported     in The North West Adelaide Health Study. According to this epidemiological survey, which was     conducted from 2008 to 2010, the prevalence of depression in Adelaide North Western general     population was 20%.During the second phase of the study investigator will evaluate the effect     of CPAP on anxiety and depression scores in the depressed and anxious patients with sleep     apnoea by comparing the pre and post CPAP anxiety and depression status. The Hospital Anxiety     and Depression (HAD) scale will be used to assess Anxiety and Depression, which is a     well-documented tool for assessing symptoms of anxiety and depression in patients with     somatic diseases.   "
99379|NCT01985334|"     The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide     and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients     with moderate COPD who switch from their current COPD therapy. This study aims to provide     data on how non-exacerbating, but still symptomatic patients with moderate COPD switching     from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and     glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study     is to increase awareness and usage of validated COPD symptoms tools and dyspnea     questionnaires in order to facilitate clinical assessment and improve early diagnosis of     symptomatic patients.   "
99380|NCT01985321|"     The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,     is safe and effective in the treatment of cold sores.      Subjects who meet the requirements to participate in the study will be put randomly, and     equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a     group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor     the site will know which treatment they will be getting. Once the subject has been assigned     to a treatment group, they will be given a kit containing a bottle of the treatment and     special swabs to apply the liquid. The subject will be told to take the kit home and wait     until they think they are starting to get a cold sore.      Once a subject begins to feel something or see something that they think is the start of a     cold sore, they are to immediately call the clinic. Once the clinic confirms that the subject     is in fact starting to get a cold sore, the subject will be told to open the kit and begin     treatment. From the start of treatment, there will be twelve (12) treatments, with either     Merlin or placebo, applied six (6) hours apart, up to 3 per day, over the next 96 hours (4     days). Each treatment of Merlin or placebo is made up of three (3) applications given twenty     (20) minutes apart, for a total of thirty-six (36) applications. FOr each application, the     subject will use the special swab to put the Merlin or placebo solution on their cold sore.      Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until     either the cold sore is completely healed or 14 days from the start of treatment, whichever     comes first. At each clinic visit the cold sore will be observed to determine at what stage     it is at or if it has healed. The subject will also be asked how they are feeling.      Subjects will also be told to record in a diary the time of each application of Merlin or     placebo. They will also be asked to record how much pain, if any, related to the cold sore,     that they are feeling.   "
99381|NCT01985308|"     The purpose of this study is to show that a magnetic field applied to the front part of the     brain of children suffering from Autism Spectrum Disorder(ASD) can improve function and     ameliorate symptoms.   "
99382|NCT01985295|"     In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in     combination with RT pre-operatively given.   "
99383|NCT01985282|"     The study is to evaluate the feasibility of the NLA tool, a combined assessment of     nutritional and physical functional status, to provide personalized advice for the     independence and mobility of elderly.   "
99384|NCT01985269|"     M-DART Study is a randomized clinical trial comparing the effectiveness of a home-based     modified directly observed antiretroviral (ART) treatment strategy to clinic-based standard     of care in patients with HIV/AIDS in Port Victoria, Busia, Kitale, Chulaimbo and Khunyangu,     Kenya.      Hypothesis 1a: It is feasible to implement M-DART in remote, poverty stricken, high-HIV     prevalence rural communities in western Kenya.      Hypothesis 1b: M-DART will be a more effective strategy than standard of care (High-Risk     Express Care) in reducing mortality and LTFU in patients at the highest risk of dying     following ART initiation.      Hypothesis 2: M-DART will be cost effective over the 48-week study period      Hypothesis 3a: Patients enrolled in M-DART will have higher quality of life scores at 24 and     48 weeks as compared to the control patients.      Hypothesis 3b: Patients enrolled in M-DART will have lower HIV related stigma scores at 24     and 48-weeks as compared to the control patients.   "
99444|NCT01984489|"     SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the     efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type     2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control   "
99385|NCT01985256|"     This is a multicenter study evaluating the safety and tolerability of Toca 511 administered     intravenously to patients with recurrent or progressive Grade III or Grade IV Gliomas who     have elected to undergo surgical removal of their tumor. Subjects meeting all of the     inclusion and none of the exclusion criteria will receive a portion of the total dose of Toca     511 administered as an intravenous, bolus injection, followed approximately 11 days later by     the remainder of the dose injected into the walls of the resection cavity at the time of     planned tumor resection. Approximately 6 weeks later, subjects will begin treatment with oral     Toca FC taken every 8 hours for 7 days, and repeated every 4 weeks. All subjects enrolled in     this study will be encouraged to participate in a continuation protocol that enables     additional 5-FC administration and the collection of long-term safety and response data.   "
99429|NCT01984684|"     The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus     Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.   "
99487|NCT01983917|"     Prospective study to evaluate whether or not an internet application to coordinate and record     diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical care team     and 3. ophthalmology vision care team will decrease vision loss and blindness due to diabetic     retinopathy. The aims will be measured through health psychology instruments to assess the     effect of the application on management, motivation to control their disease, and commitment     to comply with treatment. We will also measure objective health outcomes including Blood     Pressure, Blood lipids level, hemoglobin A1c level, and Visual Acuity.   "
99386|NCT01985243|"     Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains     high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor     nutrition contributes to about one-third of child mortality, diminishes cognitive     development, and is a major determinant of maternal mortality. The specific objectives of the     5-year project are to: (1) enhance human capacity of government, civil, and private     institutions through improvement of knowledge and skills of personnel in agriculture,     nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of local     institutions that are not presently met and develop a representative and sustainable     longitudinal data system to support evidence-based decision-making in programs; (3) increase     vulnerable households' access to quality services in agriculture/fisheries, nutrition and     health, and finance; (4) implement integrated intervention activities to improve infant and     young child and adolescent nutrition outcomes; and (5) examine differential benefits of the     interventions for diverse vulnerable populations. The project comprises two major activities:     part I - the creation of a longitudinal data system to support evidence-based decision-making     in programs, and part II - the implementation of intervention activities to improve nutrition     outcomes.      The survey will include demographic, socioeconomic, health, diet, and nutritional status     information collected annually from a representative same of 1500 households with infants     (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and     presented rapidly each year to district program and policy leaders to assist them in     developing their activity plans for the following year.   "
99387|NCT01985230|"     The purpose of this Clinical Study is to investigate the effect of electrical stimulation for     chronic low back pain.   "
99388|NCT01985217|"     Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face     genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and     more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion     is nowadays a major Public Health issue.   "
99389|NCT01985204|"     The study hypothesis is that iodine supplementation will lower serum TSH and leptin     concentrations and thereby improve the lipid and glucose profile.   "
99390|NCT01985191|"     Primary Objectives:      To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in     patients with solid tumors.      To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.      Secondary Objectives:      To characterize the pharmacokinetic profile of SAR405838 and pimasertib.      To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.      To characterize genetic status in tumor tissue and circulating tumor DNA.   "
99391|NCT01985178|"     Eating disorders are conditions that are defined by abnormal eating habits that involve     insufficient or excessive food intake. With regards to treating these disorders, there is an     increasing interest in fat deprivation due to a lack of proper diet, particularly dietary     fats such as polyunsaturated fatty acids. These fatty acids are essential components of the     brain and are important for normal functioning of the body. Since the body cannot synthesize     these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets     that lack sufficient fats or under fasting conditions, the imbalance of these fats can     severely alter brain functions. The investigators want to see if these supplements are well     tolerated and accepted by adolescent patients with eating disorders.   "
99392|NCT01985165|"     The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the     treatment of patients with knee osteoarthritis.   "
99393|NCT01985152|"     The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan     Trimethylethanolamine in healthy volunteers   "
99394|NCT01985139|"     Disturbances in hedonic and motivational processes play a major role in the pathophysiology     of obesity. To date, experimental approaches for the study of emotional and motivational     processing rely on subjective assessment scales. We have therefore developed two novel     computer-generated tasks challenging respectively visual and temporal discrimination     capacities for a quantitative and objective measurement of the hedonic and motivational state     in humans. According to the task, the subjects are asked to view and to compare two stimuli,     an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale),     at each trial, assessing either the size (task A) or the duration of presentation (task B).     From these considerations, the present project aims at using our novel tool to: i) assess the     hedonic and motivational state in subjects with obesity, ii) compare their responses with     healthy volunteers, and iii) establish relationships with biological markers known to be     highly involved in the regulation of both emotional and motivational processes, such as     endocannabinoids. The present project should demonstrate that the behavioral tests validated     in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and     for the phenotypic characterization of obese patients. The application of the test in the     therapeutic context could add further information about the efficacy and relevance of the     chosen therapy. Finally, our project will provide information on the biological substrates of     hedonic and motivational impairments that might become target of therapy in obesity.   "
99395|NCT01985126|"     The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment     regimens in participants with multiple myeloma who have received at least 3 prior lines of     therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are     double refractory to a PI and an IMiD.   "
99470|NCT01984138|"     This study is investigating whether breast cancer patients who experience vaginal dryness     while on anti-estrogen treatment could benefit from either vaginal estrogen or from a vaginal     moisturizer called Replens.   "
99396|NCT01985113|"     In pre-clinical study the investigators found that the thioredoxin reductase activity of     serum harbours huge difference between cancer patients and non-cancer patients, the enzyme     activity elevated remarkably among cancer patients, so the investigators hypothesis that this     is due to tumor cells loading of the patients, the enzyme activity may harbours huge     difference between carcinoma tissues and para-carcinoma tissues in early staged non-small     cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level     because of removing of tumor.   "
99397|NCT01985100|"     To confirm or refute recently published data regarding the reduction in post-stroke ischemic     penumbra, that used SPECT/CT, using the more precise tools of PET/MRI.   "
99400|NCT01985061|"     Albeit the safety of the stem cell transplantation procedure has been greatly improved,     further refining the intensity of the conditioning is an important issue to explore,     especially in patients with poor prognosis, the goal being to maintain the very favorable     safety profile and improve the disease control. This is the goal our prospective trial; we     aim to prospectively evaluate in a prospective multicenter trial the efficacy of different     conditioning regimens in patients with high-risk myeloid malignancies.      The study is a phase II trial randomizing patients between a prospective active control arm     (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical     trial in order to avoid the limitations induced by the comparison with historical controls in     the context of continuously improving practice. Each experimental arm will be conducted in     parallel according to a standard phase II trial design.      In addition, this trial will associate four ancillary studies to the main clinical objective:     1/ a prospective assessment of the quality of life of the patients over a period of 2 years     2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years     3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study   "
99401|NCT01985048|"     1. Primary Objectives:             -  To characterize cardiometabolic risk factor profiles of patients entering cardiac               rehab using traditional approaches (eg LDL-C) as well as a more comprehensive panel               of cardiovascular and metabolic biomarkers. It is hypothesized that the               comprehensive panel will identify further increased risk that would not have been               detected using only traditional approaches. Specifically, it is hypothesized that a               greater percentage of the cohort will be identified with high risk levels of               LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is               further hypothesized that the prevalence of elevated Lp(a) and elevated levels of               inflammatory and insulin resistance markers will be higher in this cohort when               compared to population norms (HDL, inc reference data).             -  To assess improvements in laboratory and lifestyle risk factors and rate of goal               attainment at completion of rehab (eg 3 months). This objective is primarily               descriptive, and improvements in traditional risk factors (eg LDL-C) will be               compared to existing published data. Improvements in non-traditional risk factors               (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been               extensively investigated.             -  To determine which attributes at baseline best predicted recurrent events and               re-hospitalizations assessed one year later.        2. Secondary/Developmental Objective:             -  To inform and guide development of a subsequent study protocol designed to compare               outcomes associated with biomarker-guided personalized treatment plans vs. standard               of care in the cardiac rehab setting.   "
99402|NCT01985035|"     Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition     and energy expenditure. The objective of this study is to evaluate the influence of OSA in     energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both     genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary     intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN     with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein     / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS     obese standard diet. All groups will be instructed to perform a restricted energy diet (less     30% of daily energy expenditure). At baseline and one month after the beginning of the     program the following evaluations will be conducted: total energy expenditure measured by     doubly labeled water method, resting energy expenditure and thermic effect of food by     calorimetry, polysomnography analysis, body composition by pletysmography, food consumption     by three days of food diary, blood collection for analysis of lipid profile, visceral     proteins, hormones related to control of body weight and inflammation. As hypothesis we     believe that apneic obese individuals have greater difficult in weight loss and loss more     free fat mass than the obese no apneic and that diets with more protein can contribute to     greater weight loss, better body composition and energy expenditure in these population.   "
99403|NCT01985022|"     The major purpose of this study is to directly compare two parent intervention conditions for     children diagnosed with autism spectrum disorders at 18 months of age to document the     effectiveness.   "
99416|NCT01984853|"     This is an OBSERVATIONAL Specimen procurement and data collections trial for acute coronary     syndrome that will be conducted in the Emergency Department at Henry Ford Hospital.      The standard protocol for evaluating patients in the Emergency Department for possible acute     myocardial infarction includes the measurement of cardiac troponin over 3 hours. Subjects     presenting to the ED with chest discomfort or ischemic symptoms will be eligible for blood     draw protocol. The study is blinded to treating physicians and does not change current     standard of care. After informed consent patients will have blood samples drawn at 0, 30     minutes, 1 hour and 3 hours.      Serum from the samples will be stored in a -80 research freezer to be evaluated at a later     time as new cardiac markers for acute coronary syndrome are developed.   "
101688|NCT01955096|"     The purpose of this study is to to investigate the feasibility and safety of fast-track     surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer     patients.   "
99417|NCT01984840|"     There are two main aims in this study. The first objective is to evaluate whether a     particular telehealth solution, in addition to standard treatment and care, lead to a     significant decrease in the mortality and an increase in health related quality of life for     patients suffering from COPD that may benefit from telehealth compared with only standard     treatment and care. The second objective is to examine the additional costs of the telehealth     solution and assess whether this solution is a cost-effective way to care for patients with     COPD across patients and municipality districts.      It is hypothesized that telehealth care will increase patients quality adjusted life years at     both the cluster and individual level compared to usual practice, since no difference in     mortality and a higher health related quality of life is expected. Furthermore, it is hoped     that there will be a 30% reduction in the number of admissions and readmissions to hospitals     and a 30% reduction in the number of outpatient visits resulting in fewer costs for     hospitals. However, it is uncertain as to whether these savings are offset by other costs     such as more visits to general practitioners, community care or the implementation costs.   "
99404|NCT01985009|"     The non-alcoholic fatty liver disease (NAFLD) represents the most common cause of liver     disease in the western world. It can progress from steatosis to non-alcoholic steatohepatitis     (NASH), and then onto cirrhosis where there is a concomitant risk of developing     hepatocellular carcinoma (HCC). The prevalence of hepatic steatosis is high, ranging from 16     to 31% in the general population, up to 80% in the obese populationand up to 96% in severely     obese patients.      Liver biopsy (LB) has traditionally been regarded as the gold standard for the assessment of     patients with NAFLD, although it has several limitations. LB has a potential sampling error,     is an invasive and often painful procedure.      The natural history of patients with NAFLD is generally determined by the extent of liver     fibrosis, hence non-invasive assessment of fibrosis with FibroScan® is often sufficient. For     patients with proven NASH, changes in hepatic steatosis and serum ALT levels may provide     information on the patient's course and/or response to treatment.      Several clinical studies have shown the benefit of measuring hepatic stiffness with the     FibroScan® machine using the M+ probe. The ability to identify significant fibrosis and     cirrhosis has been demonstrated in normal and overweight patients affected with chronic     hepatitis B and C, biliary diseases, alcohol related liver disease (ALD) and NAFLD.      Recently, Echosens has also developed a novel ultrasonic controlled attenuation parameter     (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled     transient elastography (VCTE™). Studies comparing CAP with liver biopsies in multi-aetiology     cases and patients with Hepatitis C Virus (HCV) have shown that there is a good correlation     between steatosis assessed histologically and using CAP.      The main objective of this prospective study is to evaluate the diagnosis accuracy of the     Controlled attenuation Parameter (CAP) measured by FibroScan® (either with M+ or XL+)in     patients with NAFLD to assess liver steatosis using biopsy as a reference.      The study involves adults' patients with suspected NAFLD scheduled to have a liver biopsy     within 2 weeks of fibroscan examination and followed by the Hepatology service of four     centers in United Kingdom.      Approximately 450 patients (of which 350 will be evaluable) will be enrolled in this study:     Around 100 patients will be measured with the M+ probe and around 250 with the XL+ probe.      The inclusion period is from 18 to 24 months. Starting date: January 2014. End of     recruitment: June 2017. The duration of the study for a patient is from 1 to 7 days,     depending to the exams calendar.   "
99405|NCT01984996|"     The primary objective of this study is to evaluate patient quality-of-life (QOL) after     inguinal hernia repair. Carolinas Comfort Scale (CCS) assessments will be held at regular     intervals.      The secondary objective of the study is to follow short-term and long-term study-related     complications/adverse events.   "
99406|NCT01984983|"     The Phase I study will assess the basic safety, tolerability, and immunogenicity of a     DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by     electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will     comprise evaluation of intradermal or intramuscular administration by electroporation.     Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0     mg/ml) for each route of administration. Electroporation will be administered using the     TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional     group of subjects will serve as a placebo control, receiving injections of saline with     electroporation. The overall goal of this study will be to determine if further human     clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection     of dose and route of administration for future studies.   "
99407|NCT01984970|"     1. Double-lumen tube intubation is difficult, compared with single lume tube.        2. McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both          in anesthetized and awake patients.        3. But there was little information about McGrath Series 5 videolaryngoscope for          double-lumen tube intubation.   "
99408|NCT01984957|"     To isolate biomarkers of ALS in muscle   "
99409|NCT01984944|"     Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by     deficits in social communication, delay in language and repetitive behaviors. Results from     genetic studies reveal one pathway associated with susceptibility to ASDs, which includes     synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the     genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently     observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with     ASD and search for circadian rhythms genes polymorphisms.   "
99410|NCT01984931|"     This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will     be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic     rotator cuff repair under general anesthesia.   "
99411|NCT01984918|"     To conduct a prospective randomized controlled study to identify predictors for colonoscopy     non-attendance and examine the efficacy of SMS reminder to improve the non-attendance rate.   "
99412|NCT01984905|"     Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of     false lumen expansion and risk of rupture. Data of literature give us some indications about     prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at     3 years despite follow-up.The only known predictive factors are the initial diameter of more     than 4 cm and the persistence of a false lumen patent.However, actual means of follow-up do     not allow to predict severe complications. The aim of the sudy is to propose a diagnostic and     preventive strategy for the follow-up of chronic type B aortic dissections treated medically.      The primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such     patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year     and/or of an aortic dissections extension at 1 year. The secondary objectives are to evaluate     the link between fibrosis biomarkers MMP et TIMP) and the results of imaging results     (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100 patients     to be included in 3 years History of chronic type B aortic dissection, treated medically,     evolving since more than 1 month and less than 5 years.      Expected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the     identification of patients at high risk of evolution. Elaboration of a decisional algorithm     about follow-up modalities of chronic aortic dissections. Demonstration of a correlation     between aortic diameter growth or aortic dissection extension and intensity of marker     fixation with 18-FDG-PET-Scan.   "
99413|NCT01984892|"     The purpose of this study is to test the safety of a course of injections containing     Poly-ICLC in patients with advanced solid tumors that can be easily and safely reached with a     needle.      Poly-ICLC is a compound that has been used to help the body in its fight against cancer.   "
99414|NCT01984879|"     The purpose of this study is to investigate the vaccination status, knowledge about     vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel     diseases   "
99415|NCT01984866|"     This project aims to determine whether biopsy using radiofrequency is a procedure suitable     for this patient selection. Findings from biopsy will be correlated with the conventional     surgery ones. If the technique is validated to predict the presence or absence of residual     tumor, breast surgery could be avoided in cases of absence of tumor.   "
112409|NCT01814579|"     This study is designed to determine if using the V-Loc Wound Closure System expedites     operative time in robotic hysterectomy.   "
99420|NCT01984801|"     The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan     will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and     safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),     after topical administration on healthy subjects and acne patients. Study SCD117225 will be a     randomized, single-blind, three part study, to evaluate the primary irritation potential     (Part 1), cumulative irritation potential (Part 2) of two concentrations of GSK1940029 gel     applied to the intact skin of healthy subjects, and the facial irritation potential of one or     two concentrations of GSK1940029 applied to the face of acne patients (Part3). In Part 1 and     Part 2 the following 6 treatments will be applied using individual patches: (A) 200     milligrams (mg) of 0.3% GSK1940029 gel, (B) 200 mg of 1% GSK1940029 gel, (C) 200 mg of     0.3%/1% vehicle gel only (vehicle control), (D) 200 microliters (µL) of sterile distilled     water (negative irritant control), (E) 200 µL of - 0.5% sodium lauryl sulfate (SLS) in     sterile distilled water for Part 1/0.1% SLS in sterile distilled water for Part 2 (positive     irritant control), and (F) Patch only (patch control). Each treatment will be randomized to     one of six designated locations on either upper arm or other locations, such as the lower or     upper back, within each subject. The same treatment will be reapplied to the same location on     subsequent days. Each treatment will be applied daily for 2 days in Part 1, and daily for 21     days in Part 2. In Part 3, each patient will apply a thin coat of one or two concentration of     GSK1940029 gel or vehicle to acne affected facial/neck skin by hand, once daily for 28 days.     Parts within Study SCD117225 and Study SCD117226 will have interdependencies. No significant     primary irritation signal in Study SCD117225 Part 1 would allow initiation of Study SCD117226     Part 1 (single dose application). Once safety, tolerability and exposure information are     determined in Study SCD117226 Part 1, Part 2 of Study SCD117225 may be initiated along with     Part 2 (14-day repeat dose application). No significant cumulative irritation signal (study     SCD117225 Part 2) in combination with adequate 14-day safety (study SCD117226 Part 2) would     allow initiation of Part 3 of Study SCD117225.   "
99421|NCT01984788|"     The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic     treatment is safe and effective in reducing the number of acute attacks in patients with     hereditary angioedema.   "
99422|NCT01984775|"     This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3     concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in     healthy subjects. Results from this study will be considered when selecting the     concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and     efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30     evaluable subjects complete the study. The total duration of subject participation may be up     to 50 days.   "
99423|NCT01984762|"     Obesity is a growing epidemic throughout the world and is followed by increasing incidence of     type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major     objective, although difficult to achieve with medical treatments. Many recent studies     demonstrated that bariatric surgery has the potency to achieve marked and sustained weight     loss, and is also associated with a significant improvement in control of type 2 diabetes.     The principal aim of this study is to compare two types of bariatric procedures, the     Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that     these procedures have equal efficacy with regard to resolution of type 2 diabetes.   "
99424|NCT01984749|"     The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral     and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for     cerebral and cardiorenovascular disease.   "
99425|NCT01984736|"     The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after     a single oral dose in subjects with mild, moderate and severe hepatic impairment compared     with subjects with normal hepatic function.   "
99426|NCT01984723|"     The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after     a single oral dose in subjects with mild, moderate and severe renal impairment compared with     subjects with normal renal function.   "
99438|NCT01984567|"     Background of the study:      We now know that plant sterols can oxidize, which results in the formation of     oxyphytosterols. Animal studies have suggested that oxyphytosterols are atherogenic     components, however this relation has not yet been studied in humans. In our previous study     (METC 09-3-088) we have shown in healthy volunteers that serum oxyphytosterol concentrations     are linked to oxidative stress status (i.e. we were able to identify high and low sterol     oxidizers). From the literature is known that especially type II diabetics and IGT subjects     are characterized by increased oxidative stress markers and reduced antioxidant capacity. For     this reason we also want to evaluate the oxyphytosterol concentrations in this population.     Moreover, we know propose to evaluate the effect of antioxidant supplementation, i.e. vitamin     E or lipoic acid, on serum oxyphytosterol concentrations in type II diabetic patients. If     possible to lower oxyphytosterol concentrations in these populations this is obviously     beneficial in case oxyphytosterols turn out to be atherogenic. The major objective of the     present study is to examine the effect of consuming vitamin E (804 mg) or lipoic acid (600     mg) for 4 weeks on fasting oxyphytosterol concentrations in subjects with impaired glucose     tolerance or type 2 diabetes.   "
99427|NCT01984710|"     Major depressive disorder is a common disease. For many people, conventional treatments such     as antidepressants are very helpful in relieving the symptoms of this condition. But as many     as 30% of patients with depression have less than a full response or become resistant to     conventional treatments. When treatment resistance develops, the depression becomes a chronic     disease with a very significant burden of morbidity and mortality. The reasons that some     patients develop Treatment Resistant Depression (TRD) are not known. One current theory for     depression is that it results from the dysfunction of a network of regions in the brain and     that in treatment resistant patients the network is permanently stuck in the dysfunctional     state. We have been investigating an experimental treatment for treatment resistant     depression (TRD), based on this network theory known as subcallosal deep brain stimulation     (SCC DBS). This treatment involves placement of electrodes in a specific region of the brain     (subcallosal cingulate cortex, area 25) and then stimulating that area with electricity,     which resets the regulation of the network resulting in a significant antidepressant     response. While still experimental our results suggest this may eventually be a useful     treatment for some patients with TRD. The experiment described in this application is to use     a new DBS device that can record the electrical activity in the brain around the site of     stimulation. The electrical activity is known as Latent Field Potential (LFP) and is a     reflection of the activity if the neural network. The new DBS device is an experimental     device that has not been approved by the Food and Drug Administration (FDA), but allows for     simultaneous recording of LFP while stimulation is being delivered. The device is     manufactured by Medtronics and is known as Activa Primary Cell + Sensing(PC+S), but because     it can be used to record the brain electrical activity it is also known as the Brain Radio.     The Brain Radio is based on an approved device commonly used for DBS for other conditions     that has the added sensor capacity. The stimulation system is identical to that in the     approved device. The goal of this investigation is to use the Brain Radio to study LFP in the     brains of people with TRD before and during active stimulation. The ultimate goal is to     understand the neural network that causes TRD and the changes that DBS cause in that network     that results in the antidepressant effects. We will recruit 10 patients with advanced TRD and     implant them with the Brain Radio system. The recording system will be to record LFP over 3     years, while patients receive stimulation. A brief discontinuation study will be conducted     after 6 months of stimulation when the device will be turned off and patterns of LFP changes     will be recorded. All LFP measures will be correlated with the primary clinical response     outcome metric, the Hamilton Depression Rating Scale. The knowledge gained with this     experiment will be invaluable to understanding the basic pathology of depression and the     antidepressant response. This is a unique, first in humans test of this device and as such     the results are expected to impact our understanding of depression at a fundamental basis.   "
99428|NCT01984697|"     This study is a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14     years of age and in young women 16 to 26 years of age. From this study, the goal is to     establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in     boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody     response that is not inferior to that observed in young women 16 to 26 years of age who     received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to     establish V503 efficacy).   "
99430|NCT01984671|"     Persistent pain is a major challenge for patients who undergo hematopoietic stem cell     transplant (HSCT) and is related to more fatigue, more physical disability, poorer quality of     life, and poorer medical adherence. There is a need to examine strategies for managing pain     in HSCT patients that can complement existing analgesic regimens. Strong evidence suggests     that cognitive and behavioral factors play an important role in HSCT patients' ability to     manage their pain. The investigator has found that HSCT patients having low levels of     confidence (i.e., self-efficacy) in their ability to control pain and high use of maladaptive     coping strategies (i.e., pain catastrophizing) experience increased pain and disability. A     psychosocial intervention that modifies patients' cognitive and behavioral pain coping     strategies may benefit HSCT patients. Protocols, particularly Pain Coping Skills Training     (PCST), have been developed for reducing pain and improving quality of life in patients with     persistent pain. However, HSCT patients with persistent pain face a number of unique     challenges that must be considered when applying a PCST protocol. The investigator proposes     to develop and test a Mobile Health Pain Coping Skills (mPCST) protocol for HSCT patients     with persistent pain to meet the challenges of HSCT patients with pain as they transition     from hospital based care to their home environment. The first aim of this study is to use an     iterative development model to design a mPCST intervention protocol for HSCT patients that     targets increasing self-efficacy for pain control and decreasing pain catastrophizing. The     study team will use focus groups with patients and HSCT providers to guide development along     with user testing with HSCT patients having pain. The second aim of this study is to use a     small randomized controlled trial to examine the feasibility, acceptability, and engagement     in the developed mPCST protocol. The third aim is to obtain an estimate of the effect size of     the developed mPCST protocol on decreased pain, pain disability, physical disability, and     adherence to post-transplant lifestyle recommendations impacted by pain when compared to a     standard care control condition. Proposed innovative features of the mPCST protocol that will     be developed include: extensive input from PCST and HSCT experts and HSCT patients with pain;     an initial session prior to discharge with subsequent sessions occurring at home via     video-conferencing; incorporation of strategies to decrease the impact of pain on adherence     to critical post-transplant lifestyle recommendations; a real-time daily assessment system     with subsequent tailored feedback. If the developed mPCST protocol demonstrates feasibility,     acceptability, engagement, and promising effect sizes to influence pain and other indices of     quality of life, a larger NIH grant will be sought to examine this protocol in a larger     sample of patients, test the protocol against an active treatment, and investigate a broader     array of outcomes (e.g., medication adherence). This mPCST protocol could also be examined in     other patient populations with pain facing similar challenges (e.g., live far from medical     center, travel limitations).   "
99432|NCT01984645|"     New York-Presbyterian Hospital has created a system that notifies its primary care providers     whenever their patients are admitted to the hospital. In this study, the investigators want     to evaluate how accurate this system is and how it is affecting the primary providers and     their health care delivery.   "
99433|NCT01984632|"     The aim of this study is to test our hypothesis that the use of unidirectional knotless     barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine     wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.   "
99434|NCT01984619|"     To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for     the treatment of forehead wrinkles.   "
99435|NCT01984606|"     The purpose of this study is to assess safety and efficacy of empagliflozin compared to     sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment     with metformin and have insufficient glycaemic control. The study will assess non-inferiority     of empagliflozin to sitagliptin with regards to HbA1c.   "
99436|NCT01984593|"     The purpose of this study is to determine the effects of a short yoga program practiced daily     at home on blood pressure, quality of Life and stress. The subjects of the study are primary     health care patients diagnosed with hypertension, with or without current medication.   "
99437|NCT01984580|"     Using orally administered zinc to patients already diagnosed with the pre-cancerous     condition, Barrett's Esophagus, this study is asking two questions:        1. can this zinc administration cause molecular-level changes in the Barrett's tissue?        2. are the changes measured indicative of chemopreventive action by zinc regarding cancer          progression?   "
99439|NCT01984554|"     The primary objective of this study is to compare the total costs to sites and payers of     administering IV iron over the 30-day observation period for subjects with IDA who receive     Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and     ferumoxytol.   "
99445|NCT01984476|"     As the spinal cord injured population ages, these individuals are being exposed to an     increased prevalence of age-associated diseases, which coupled with the secondary     complications of the injury may contribute to the reduced life expectancies. Decentralized     autonomic regulation in persons with SCI results in a multitude of cardiovascular changes,     which may contribute to accelerated aging. Adverse cardiovascular changes may have     deleterious effects on cerebral blood flow dynamics and an increase in cerebral vascular     resistance index in individuals with SCI during cognitive testing. Deficits in memory and     processing speed in individuals with SCI may relate to cardiovascular and cerebrovascular     dysfunction. Identifying the associations between healthy aging versus premature or     accelerated aging in organ system function in the SCI population is an important first step     towards prevention and amelioration of these changes. Therefore the study objectives are to     compare, among individuals with SCI, age-matched non-SCI and older non-SCI individuals     arterial stiffness and cerebral vascular resistance index; memory, processing speed, and     executive function; and volume of white matter hyperintensities. 60 individuals with SCI, 30     age-matched non-SCI controls, and 20 older non-SCI controls will be recruited for this study.     All potential subjects will undergo a two-part screening process which consists of an initial     screening via telephone and a detailed, in-person screening. Eligible subjects will be     invited to participate in a 4 hour laboratory visit during which their arterial stiffness,     blood pressure, heart rate, respiration rate and, blood flow to the brain will be monitored     at rest and during a comprehensive series of cognitive tests. A subset of the participants     will be asked to take part in an MRI brain imaging session: 40 persons with SCI, 10     age-matched non-SCI and 10 older non-SCI. Eligible subjects will be asked to participate in a     1 hour MRI/functional magnetic resonance imaging(fMRI) session.      We hypothesize that arterial stiffness and cerebral vascular resistance index will be     increased in the SCI group compared to the age-matched non-SCI but will be comparable to the     older non-SCI groups. In addition, we hypothesize that the prevalence of mild to moderate     cognitive impairments in memory, processing speed, and executive function will be increased     in the SCI individuals compared to the age-matched non-SCI but will be comparable to the     older non-SCI individuals.   "
99446|NCT01984463|"     This study is designed to assess the impact of epidural morphine on:        -  The incidence and severity of shoulder pain following a thoracotomy.        -  The need for additional analgesics, such as opioids for the relief of shoulder pain.        -  Its safety profile compared to epidural fentanyl following a thoracotomy.      The basic hypothesis of this study is that an infusion of epidural bupivacaine and morphine     initiated after the induction of anesthesia and continued until 72 hours postoperatively will     reduce the incidence and severity of shoulder pain following a thoracotomy when compared to     an epidural infusion of bupivacaine and fentanyl.   "
99454|NCT01984359|"     To assess in an exploratory manner, the pronostic utility for locoregional control,     progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood     DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer     patients. This will entail analysis of both initial pre-therapy HPV level as a continuous     variable and initial post-therapy HPV level as a dichotomous variable.   "
99455|NCT01984346|"     This is a multi-center, open label, randomized pivotal study evaluating the safety and     efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF     patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug     (AAD).   "
99488|NCT01983904|"     The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep     brain stimulation (DBS) in patients with treatment resistant depression (TRD).      The working hypotheses are that long pulse-width DBS applied to the SCC region will lead to     improvements in TRD patients, and specific neuroimaging biomarkers will correlate with     response to DBS; the functional recovery will be enhanced with concurrent cognitive     behavioural therapy (CBT).   "
99447|NCT01984450|"     Study Title: A study to compare two articular cartilage repair techniques in the knee joint:     Autologous Collagen Induced Chondrogenesis (ACIC) Vs. Mesenchymal Cell Induced Chondrogenesis     (MCIC).      Study hypothesis: We start with the hypothesis that both treatments are equally effective.      Trial Design: This is a prospective study. The participating patients will be divided into     two groups, each group receiving either one of the treatment modalities. This study will not     be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by     Professor A. A Shetty, who is one half of the team that devised both techniques.      Trial Participants: All participants will be from patients attending Professor Shetty's     clinic at the Spire Alexandra Hospital.      Planned Sample Size: 50 patients in each arm.      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3     months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and     assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm     scores; cartilage growth will be measured by the MOCART score.      Planned Trial Period: Two to three years      Primary Objective: To establish superiority, if any, of either procedure over the other.      Primary Endpoint: At the end of the 2 year follow up for all participating patients.   "
99448|NCT01984437|"     The purpose of the registry is to gather both retrospective and prospective case data on the     use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in     accordance with the approved intended use. For prospective cases, follow-up patient data will     be collected at 14 days (± 5 days) post procedure to assess treatment success, primary     patency of intended targeted vessel region, and adverse events.      The data will be analyzed for medical education, societal presentation, and/or publication by     the investigators.      Over the next 2+ years, physicians who meet the selection criteria will be invited to     participate in the registry.   "
99449|NCT01984424|"     The study is divided into 3 parts (A, B, C). Part A is a double-blind, placebo-controlled,     two-period cross-over rechallenge of atorvastatin 20 mg. Part B is a 24-week double-blind,     double-dummy comparison of evolocumab and ezetimibe. Part C is a 2-year open-label evolocumab     extension. The primary hypothesis is that evolocumab will be well tolerated and will result     in greater reduction of LDL-C than ezetimibe, defined by the mean percent change from     baseline at Weeks 22 and 24 of Part B and percent change from baseline at Week 24 of Part B,     in statin-intolerant hypercholesterolemic subjects.   "
99450|NCT01984411|"     Cardiac catheterization is the most important test for the evaluation of cardiac patients.     Since the beginning of the cardiac catheterization procedure, we have used the femoral artery     puncture as a gateway for those procedures. Recently it is used more often the path for the     radial. Using this approach has gained many followers worldwide and has been used almost     routinely in our country but has not gained popularity because many interventional     cardiologists argue that the transradial procedure is much more time-consuming and difficult.      Research question: Are there differences in the total procedure time path between radial and     femoral vascular to perform cardiac catheterizations?.      This research focuses on the search for information to determine whether there are     significant differences when the variables under study. This research is justified by the     need to evaluate the two techniques in use and the lack of studies evaluating and comparing     the radial arterial access in comparison with femoral access route which is widely used in     all services hemodynamics national and international. The lack of research on the subject has     made the use of the transradial procedure routinely not being done, because they have the     idea that it is much more time-consuming and technically more difficult than the procedure     performed by the femoral approach, hence Hemodynamics specialists, not everyone wants to     start implementing the systematic use of the radial approach for cardiac catheterization     studies.The main objective of this project is to determine the non-inferiority in terms of     total procedure time path between radial and femoral vascular to perform cardiac     catheterizations. Secondary objectives: the difference in time of puncture, duration of the     procedure and recovery. Incidence of vascular complications and techniques between radial and     femoral, presence of complications at 8 days of follow-up. Our aims to check through the     results, if the difference in each of the variables favoring either of the two techniques and     to determine the non-inferiority of one technique over the other in terms of ease and     effectiveness of both procedures. The type of study is a controlled clinical trial open,     randomized, non-inferiority. The study population will consist of patients who have been told     the diagnostic cardiac catheterization, they are sent to the General Clinic Northern     institution.   "
99451|NCT01984398|"     To determine and compare the pharmacokinetics (PK) of a single dose of each of two     formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to     determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25     mg Androxal administered to healthy male volunteers.   "
99471|NCT01984125|"     Although most US adolescents visit their primary care doctor, their immunization rates are     low. Primary care practices from two networks, one in upstate New York as well as a national     network of pediatric clinics were surveyed to ask what they thought was the best strategy to     increase immunization rates. Point-of-care prompts (either by an electronic health record     message or by a nurse) when an adolescent patient comes in for any type of visit and is due     for a vaccine was chosen. This study will determine if these prompts will increase     immunization rates after a 12-month intervention period.   "
99472|NCT01984112|"     The hypothesis of this study is to determine whether the technique of intramedullary locking     nail presents clinical results comparable to the technique of locking plates, based on the     Constant Score.   "
99452|NCT01984385|"     Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the     incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years     presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This     pilot study will assess the feasibility of a larger prospective international cohort study.     After eligibility has been confirmed and informed consent has been obtained, participants     will be registered in the study. Troponin level, complete blood counts and serum creatinine     level will be collected at day 1 through day 10 post admission. CAM instrument will be     employed at admission and once daily post admission day 1 through day 10. FIM Instrument will     be administered within 72 hours of admission to establish pre-fracture functional     independence and disability. Patients will be contacted by research personnel by telephone 30     days after study registration.   "
99453|NCT01984372|"     This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to     assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in     patients with diabetes mellitus requiring insulin therapy under normal clinical practice     conditions.      A total of 4000 patients will be enrolled to investigate long term (3 years of treatment)     safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an     early stage of the PMS more precisely. At the time of enrolment the patients will be randomly     allocated to either 3 years or 6 months observation group.   "
99690|NCT01981252|"     This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled     subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each     treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following     treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at     each follow-up visit.   "
99456|NCT01984333|"     Trichotillomania (TTM) remains one of the most poorly-understood and inadequately-treated     conditions. Research has shown poor response inhibition (RI; the ability to inhibit     inappropriate but potent response) as an important cognitive feature of TTM. Investigators     have developed a computerized training program that aims to improve RI. Fifty children with     TTM will be randomly assigned to (a) online 8-session RI training (n=25), or (b) 1-month     waitlist condition (n = 25), and will be assessed at baseline, post-treatment, and 1-month     follow-up. Investigators hypothesize that the online RIT will show greater improvement in TTM     symptoms and RI capabilities at post-treatment and 1-month follow-up assessments, compared to     the waitlist condition. This study will help develop an effective cognitive intervention     program for TTM.   "
99457|NCT01984320|"     The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.   "
99458|NCT01984307|"     To characterize and estimate the size of different populations with a history of acute     coronary syndrome in Sweden. To assess the burden of illness (co-morbidities, mortality rates     healthcare resource utilization and atherothrombotic events) among patients with a history of     myocardial infarction (MI) 1-3 years ago and additional risk factors for atherothrombosis.   "
99459|NCT01984294|"     This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose     combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or     treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.     A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment,     approximately 60 having had prior treatment with a regimen containing pegylated interferon     (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus     treatment-experienced and by HCV genotype (1a versus 1b).   "
99460|NCT01984281|"     The purpose of this study is to determine whether a pedometer-based unsupervised exercise     program is more effective than a general exercise recommendation to increase lifestyle     physical activity in adult patients with asthma.   "
99461|NCT01984268|"     Adenocorticotrophic Hormone provides safe and effective treatment to induce disease remission     in rheumatoid arthritis patients with active disease due to an inadequate response to     methotrexate.   "
99462|NCT01984255|"     This is a Open label, two-arm, randomized, two agent, single center trial.   "
99463|NCT01984242|"     This multicenter, randomized, open-label study will evaluate the efficacy, safety and     tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus     sunitinib in participants with histologically confirmed, previously untreated locally     advanced or metastatic renal cell carcinoma who have not received prior systemic therapy     either in the adjuvant or metastatic setting.   "
99464|NCT01984229|"     This open-label study will investigate whether multiple oral doses of posaconazole affect the     single dose pharmacokinetics of alectinib in healthy volunteers.   "
99465|NCT01984216|"     The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth     II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.   "
99466|NCT01984203|"     This study aims at determine if Progressive Heavy Load Exercises (PHLE) as treatment for     patients diagnosed with Rotator Cuff Tendinopathy is superior to Standard Low-Load     Exercises (LLE).   "
99467|NCT01984190|"     Venous thromboembolic events (VTE), either deep vein thromboses or pulmonary emboli, are     important complications in patients undergoing knee or hip arthroplasty. This multicenter     Clinical Registry is aimed at collecting large volume clinical effectiveness data of     ActiveCare+S.F.T® mobile compression device +/- aspirin in lowering the potential risk of     venous thromboembolism (VTE) prophylaxis in patients undergoing primary lower extremity total     joint arthroplasty. The results can then be compared to pharmacology protocols.   "
99468|NCT01984177|"     This study will, in a sample of cocaine-dependent and healthy control subjects, administer     corticorelin and compare dopamine release between groups. Dopamine release will be measured     using PET neuroimaging with the radiotracer [11C]-(+)-PHNO.   "
99469|NCT01984164|"     The aim of this study is to conduct a 1-year double blind randomized control trial comparing     candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive     impairment in their effects on executive function, neuroimaging markers, and vascular     indicators.   "
99474|NCT01984086|"     This is an open-label, two part, six period- cross over, randomised, single dose, single     centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study     is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of     salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus     or MDI. For this reason four treatment doses consisting of three dose strength and two     percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide     preliminary PK variability estimates to allow for better sample size/precision calculations     for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile     that is comparable to either Diskus or MDI in the presence of the charcoal block.   "
99475|NCT01984073|"     The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN     (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more     efficiently. This is important because people with dyslipidemia have a problem with how they     process fat, which raise the risk of heart disease.   "
99476|NCT01984060|"     The overall purpose of this research is to evaluate the effect of a home-based exercise     program on physical function and to improve the health and quality of life for the     HIV-infected older adult community.   "
99477|NCT01984047|"     The primary purpose of this study is to evaluate the safety, tolerability and     pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a     screening visit and if eligible and consenting, will attend to participate in the study     within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing     when each subject will receive a single intravenous dose of GSK3050002 or placebo, then     remain in house under supervision until discharged on Day 3. Subjects will then return for 7     outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be     7-14 days following the last visit.   "
100072|NCT01976273|"     The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser     Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.   "
99478|NCT01984034|"     Background: The Portuguese National Health Directorate has issued clinical practice     guidelines on prescription of anti-inflammatory drugs and COX-2 inhibitors, acid suppressive     therapy and proton pump inhibitors, and anti-platelets. However, their effectiveness in     changing actual practice is unknown. The objectives will be to compare the effectiveness of     educational outreach visits in the implementation of clinical guidelines in primary care in     Portugal against usual implementation strategies and to conduct a cost-effectiveness analysis     of this method.      Methods: The trial will be a parallel, cluster-randomized, unblinded, trial in primary care,     with a 1:1 allocation ratio. This study will assess the effect of educational outreach visits     on physician compliance with prescription guidelines. The general study hypothesis is whether     educational outreach visits are superior to usual implementation of guidelines regarding the     reduction of inappropriate prescribing (compliance with prescription guidelines). All     National Health Service primary care units in the Lisbon (Portugal) region will be invited to     participate. Units will be eligible if they are using an Electronic Health Record to issue     prescriptions and have at least four doctors willing to participate. Doctors in intervention     units will receive three educational outreach visits (one for each guideline) during a six     months period, while the control group doctors will be offered an unrelated group training     session (on using the international classification for primary care). Intervention visits     will be one on one 15 minutes discussions conducted by guideline authors or trained family     physicians at the physician's workplace. There are two primary outcomes, measured at the     physician's level. One is the proportion of COX-2 inhibitors prescribed within the entire     NSAID class, in defined daily doses 18 months after the intervention. The other is the     proportion of omeprazole within the entire proton pump inhibitors class, in defined daily     doses at 18 months post-intervention. Prescription data will be collected from the regional     pharmacy claims database.   "
99479|NCT01984021|"     The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain,     cervical range of motion and electromyographic activity of the upper trapezius muscle in     patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy     subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will     receive two forms of treatment in random order: a single session of traditional acupuncture     and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period     will be respected between sessions. Surface electromyography will be used to determine motor     control in the upper trapezius muscle before and after treatment. The outcome measures in the     group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum     pain]), documentation of the pain area on a body chart and cervical range of motion. Linear     regression analysis will be applied for each individual to investigate associations between     the sEMG variables and force (excluding the sixth step). The slopes of the regression lines     will be used to measure the sensitivity of the sEMG variables regarding changes in force. The     Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS     and MDF values in the third and sixth step of the step contraction. Paired samples (Student's     t-test or Wilcoxon test) will be used to test differences between third and sixth contraction     step. A mixed linear model will be used to analyze and compare the sEMG data during sustained     contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2)     evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the     activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and     cervical ROM data collected during the four evaluations will also be compared using a mixed     linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows)     will be employed for the statistical analysis, with the level of significance set to 5% (p <     0.05).   "
99480|NCT01984008|"     The primary objective of this study is to demonstrate that investigation medication     (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with     regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An     additional objective of this study is to collect subject's response to the acceptability and     tolerability about bowel preparation and safety information.      After bowel preparation, independent evaluator who is blinded to subject's treatment will     evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600     eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation     to 1 of 2 treatment groups: Bowklean or Klean-Prep with Dulcolax. Each subject's     participation is expected to be maximally 4 weeks in study duration (up to 3-week screening     period followed by one week post colonoscopy).   "
99481|NCT01983995|"     Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with     breast cancer. These medications can cause side effects in some women, and occasionally they     can be quite bothersome. We are doing a study to better understand the side effects of     aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In     particular, we are interested in pain and difficulty sleeping. This study is designed to     assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the     interplay of these side effects and their subsequent impact on daily activity. Each     participant will fill out a series of questionnaires about pain, sleep quality, and fatigue     and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting     an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these     symptoms so we can better manage medication toxicity in the future.   "
99482|NCT01983982|"     Many breast cancer survivors report chronic pain that develops or worsens following     chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In     this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain.     We are also investigating whether a patient's sensitivity to pain is related to how many     symptoms she experiences during treatment.   "
102036|NCT01950689|"     The purpose of this study is to see whether adding Nimorazole to standard radiotherapy     benefits patients with locally advanced head and neck squamous cell carcinoma.   "
99483|NCT01983969|"     The goal of this clinical research study is to find the highest tolerable dose of azacitidine     that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell     transplant, and with or without rituximab. Researchers also want to learn about the safety     and level of effectiveness of this combination.   "
99484|NCT01983956|"     It is assumed that an early palliative care structured by SENS (a systematic, problem-based     assessment system) in addition to standard oncology care compared with standard oncology care     alone relieves distress in patients with advanced cancer at the end of life.      The primary objective of the trial is to determine the effectiveness of early palliative care     intervention, structured by SENS (a systematic, problem-based assessment system) in addition     to standard oncology care, compared with standard oncology care alone to relieve distress a)     in patients with advanced cancer until death, and b) in caregivers. The secondary objectives     are to determine whether the introduction of SENS improves quality of life, prolongs overall     survival, ameliorates distress of caregivers, reduces health care costs and medical resource     utilization (less aggressive treatment in the last weeks of life).   "
99485|NCT01983943|"     The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to     determine if six month supplementation of olive oil can improve the health of the blood     vessels and improve long term health of the heart and blood vessels, in patients requiring     percutaneous coronary intervention (PCI).   "
99486|NCT01983930|"     The purpose of this pilot study is to test whether 6 months of supervised weekly Kundalini     yoga classes and a brief daily meditation homework assignment can improve memory and thinking     in older adults with mild memory complaints when compared to weekly classes of memory     training with daily homework assignments.   "
99489|NCT01983891|"     This is a pilot intervention study conducted in four food shelves in the Twin Cities area.     The aims of the study are to improve nutritional outcomes and client skills and self-efficacy     among a culturally diverse group of food shelf clients through a nutrition education and meal     preparation program. This study will also identify opportunities to expand the supply of     healthy and culturally relevant foods in food shelves. The goal is to inform a larger-scale     intervention to improve the nutritional quality and cultural relevance of food shelf items as     well as client outcomes. The primary outcome is participant change in Health Eating Index     scores from pre-intervention to post-intervetion.   "
99490|NCT01983878|"     The purpose of this study is to evaluate progression-free survival in participants with     gastric or gastroesophageal junction cancer who have had disease progression following     first-line therapy who undergo treatment with ramucirumab.   "
99491|NCT01983865|"     This clinical validation study is aimed at establishing a birch pollen challenge in the     Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a     validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether     the challenge is dose dependent and reproducible.   "
99492|NCT01983852|"     Background Children living with life-limiting conditions have always been part of the health     care system. Although there have been dramatic improvements in medical care, hundreds of     children continue to die annually. The field of paediatric palliative care (PPC) and     end-of-life (EOL) care is based on the principle that an interdisciplinary team should care     for patients and their families. However, evidence on how to provide optimal PPC and EOL care     covering the needs of children and their families is scarce and lags substantially behind     that in the adult world. Few is known on how EOL care - defined as the last four weeks of     life in this study - is presently provided in the Swiss health setting. The presented study     Paediatric End-of-LIfe CAre Needs in Switzerland [PELICAN]) covers paediatric EOL care and     will contribute to a comprehensive understanding of EOL care in Switzerland by analysing     retrospectively medical charts of children/young people between 0 - 18 years who died in the     years 2010 and 2011 in Switzerland. A survey instrument will be developed and pilot tested to     assess the perspectives of families who have experienced the loss of a child. After the     development pilot testing and adaptation of the instrument a survey with parents who lost a     child in the years 2010 and 2011 will take place. Furthermore, the experiences and needs of     health professionals working in the field of pediatric EOL will be explored.   "
99493|NCT01983839|"     At the Department of Infectious Diseases, Aarhus Denmark, moxifloxacin is used in the     empirical treatment of severe community-acquired pneumonia (CAP). This study was designed to     determine the pharmacokinetics of moxifloxacin 400 mg/day to patients treated empirically for     CAP. To accomplish this aim, we established a pharmacokinetic population model. This approach     was adopted with the dual purpose of assessing the potential efficacy of the drug and     performing Monte-Carlo simulations to characterize the maximal MICs for which recommended     pharmacokinetic-pharmacodynamic (PK-PD) targets are obtained for pathogens commonly known to     cause CAP.   "
99494|NCT01983826|"     The overarching question addressed in the current project is: Does dietary nitrate     supplementation (8 weeks) improve physiological function in patients with peripheral arterial     disease (PAD)? The investigators will specifically address whether dietary nitrate     supplementation enhances blood vessel function, blood pressure regulation, and exercise     capacity. The proposed project uses an array of clearly defined measurements which will allow     investigators to quantify blood vessel function (vasodilator responsiveness and arterial     stiffness), blood pressure (variability and responsiveness to stress), and functional     capacity before and after 8 weeks of dietary supplementation.   "
99495|NCT01983813|"     The trial will examine whether a centralized Prevention Health & Cardiovascular Risk Service     (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary     care offices and whether it can improve the care delivered to patients at risk for developing     cardiovascular disease. The study will be conducted in 12 medical practices in Iowa that are     either a Federally Qualified Health Center or part of the IRENE practice-based research     network.   "
99496|NCT01983800|"     Heavy sedation or sleep is a common problem within the intensive care unit (ICU) using our     standard intravenous medications. This commonly leads to confusion, low blood pressure, slow     wake up and removal of the artificial breathing tube (extubation), which prolongs ICU stay.     Using inhaled volatile anesthetic agents are likely to improve these patient outcomes. This     unique project is the first North American study looking at using volatiles for patients who     need longer-term ICU sedation. This project has excellent potential at lowering these     complications and improving quality of care, which will lower patient ICU stay and healthcare     costs.   "
99497|NCT01983787|"     At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion     with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in     patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).      It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood     test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.   "
99498|NCT01983774|"     Gastroesophageal reflux disease is a common problem in cystic fibrosis (CF). It may lead to     worsening lung function and more respiratory infections for a person with CF. This study will     look at treating GERD with a medication, esopmeprazole. The medication stops stomach acid     from being made. The study will see if there are fewer respiratory infections and improved     lung function in patients with CF when taking esomeprazole.   "
99553|NCT01983228|"     The long term goal is to improve the quality and equity of chronic pain treatment among VA     patients. The primary objective of this study is to improve pain outcomes among black VA     patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and     outcomes than their white counterparts. The work proposed is expected to result in a     non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve     functioning among black patients with MSK pain, by promoting walking. This intervention is     specifically designed to address factors that contribute to MSK pain among black Veterans;     however, the investigators expect that it will also benefit non-black Veterans. The proposed     research is innovative, in its use of proactive outreach and recent advances in     self-regulation strategies (such as Action Planning) to help black Veterans overcome     psychological, environmental, utilization-related, and provider-related barriers that     contribute to pain.   "
99499|NCT01983761|"     The goal of this clinical research study is to learn if it is safe and feasible to transplant     patients with one of two units of cord blood that has been changed in the laboratory before     it is given. Only patients with leukemia, lymphoma or myelodysplastic syndrome will be     allowed on this study. The secondary goal is to obtain the preliminary efficacy outcome.     Researchers also want to learn if using cord blood that has been changed can help to control     the disease.      One cord blood unit will not be changed before it is administered to you. The cord blood unit     that will be altered will be changed to use sugar that is found in small amounts in blood     cells. It plays a role in telling transplanted cells where they should go in the body. Adding     more sugars to the cord blood cells in the laboratory helps the cord blood cells find their     way to the bone marrow faster. This process is called fucosylation.      Conditioning is the chemo and other medicines and will be given to patients to prepare to     receive cord blood transplant cells. This prevents immune system from rejecting the cells.     Conditioning will be started before the transplant.      ATG is a protein that removes immune cells that cause damage to the body.      Clofarabine is designed to interfere with the growth and development of cancer cells.      Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer     cells to die. This chemotherapy is also designed to block your body's ability to reject the     donor's bone marrow cells.      Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells     to die.      MMF and tacrolimus are designed to block the donor cells from growing and spreading in a way     that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue     attacks the recipient's body). This may help to prevent GVHD.      Rituximab is designed to attach to cancer cells, which may cause them to die.      A Phase I study for treatment of patients (N=25) with hematologic malignancies and MDS who     are candidates for dual-cord UCBT is ongoing at M.D. Anderson Cancer Center under an     Investigator-initiated IND Application, E.J. Shpall, MD, PI. Since August, 2012, Preliminary     results indicate that ASC-101 UCBT is well-tolerated and no ASC-101 related untoward adverse     events have been observed. To date, the median time to neutrophil engraftment (N=9) is 15     days, and the median time to platelet engraftment (N=9) is 33 days. The trial remains     ongoing.   "
99500|NCT01983748|"     Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence     for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with     autologous Tumor RNA.      200 patients will be included. The Trial is an open multicenter Phase III Trial.   "
99501|NCT01983735|"     The aim of present study is to evaluate the efficacy and safety of two dose combination of     Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg     and 5mg) in patients with Stage 2 hypertension.   "
99502|NCT01982760|"     This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce     bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a     drug used in patients with bleeding disorders. It works by activating molecules in the blood     stream called platelets that promote clotting. In the study, participants who are have     cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive     medication. Photographs taken before and shortly after surgery will be evaluated for the     amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not     eligible to participate.   "
99503|NCT01982747|"     MGN1703 is being developed for use in treating cancerous tumors effecting the colon, skin,     kidneys and lungs. The dosage form of MGN1703 under investigation is an injection.      The goal of this study is to evaluate the effects of MGN1703 on the electrical activity of     the heart in healthy subjects and to look at general safety.   "
99504|NCT01982734|"     Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous     health-promoting activities. The oral bioavailability of curcumin is low due to its poor     aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion.     Therefore, we tested, in a randomized crossover study, simultaneous application of     phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the     absorption of curcumin into the body. Furthermore, we investigated age and sex differences in     curcumin pharmacokinetics.   "
99505|NCT01982721|"     The investigators hypothesize that a new automatic prosthetic knee locking mechanism will     improve gait characteristics during an induced controlled trip and reduce fear of falling.   "
99547|NCT01983306|"     The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333     doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain     taking opioids.   "
99548|NCT01983293|"     The purpose of this study is to analyze the effect of left ventricular (LV) lead pacing     location in the non-left bundle branch block (NLBBB)heart failure (HF) patient population.     The LV lead pacing location will be guided by either the pacing site with the largest amount     of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of     care implant approach.   "
99549|NCT01983280|"     Adequate sleep is an important aspect of any healing process, and because it is known that     children recovering from burns suffer long term sleep disruptions, the investigators believe     that Healing Touch may improve the quality and quantity of sleep in the pediatric burn     population.   "
99550|NCT01983267|"     Cannabis sativa is one of the most ancient psychotropic drugs known to humanity. Although     most Western countries have outlawed the use of cannabis according to the UN Convention of     Psychotropic Substances, an increasing number of states in the USA, Canada and several     European countries allow the medicinal use of cannabis subject to a doctor's recommendation.     In oncology, the beneficial effects of treatment with the plant or treatment with medicine     produced from its components are related to symptoms of the disease: pain, nausea and     vomiting, loss of appetite and weight loss. There is only partial clinical evidence of the     efficacy of cannabis for these indications. In Israel, according to Ministry of Health     regulations, permission to use medicinal cannabis for oncology patients can be given for two     indications: to relieve disease-related symptoms in advanced disease or during chemotherapy     treatment to reduce side effects. The indications are very wide and allow a great deal of     freedom for the physician's decisions, but also cause high demands for cannabis from     patients.      The cannabis plant and the synthetic drugs based on the plant are considered to be medically     safe. Most of the adverse effects are related to the fact that the plant and the drugs are     psychoactive. Among the effects named were dizziness, euphoria, difficulty concentrating,     disturbances in thinking, memory loss, and loss of coordination.      Recently, we published the results of a prospective, observational study evaluating the     medical necessity for medicinal cannabis treatment in cancer patients on supportive or     palliative care. No significant side effects, except for memory lessening in patients with     prolonged cannabis use (p=0.002), were noted.      Chemotherapy-related cognitive impairment (CRCI) is a phenomenon of cognitive decline that     patients may experience during or after chemotherapy. Memory loss and lack of concentration     and attention are the most frequent symptoms encountered. Evidence suggests that CRCI is of     significant concern to patients and has become a major quality-of-life issue for survivors,     with estimates of its frequency ranging from 14-85% of patients. The influence of cannabis     use on cognitive functions of oncology patients has never been tested. Theoretically, the     combination of chemotherapy and cannabis can cause severe reduction in cognitive functions in     additive or synergistic ways. However, this hypothesis, too, has never been tested, although     the number of patients using cannabis during chemotherapy treatments in Israel and in other     Western countries is growing.      Goals of current research: The main goal of the study is to evaluate prospectively the level     of reduction in cognitive function of cancer patients who are on active oncology treatments     and use cannabis, comparing to a group of patients without cannabis treatment. The second     goal is to identify high-risk groups for cognitive impairment due to cannabis use.      Patients and Methods: The study will be comprised of a cannabis user group that will include     patients who will come for guidance sessions before being issued with a cannabis license and     a control group of patients on active oncology treatments, meeting the same inclusion and     exclusion criteria (except for cannabis use), and willing to complete the same pack of     questionnaires and cognitive tests at the same three time points. All patients will sign an     informed consent form. The study includes questionnaires on quality of life (EORTC-Q30),     anxiety, depression (HADS) and fatigue (BFI), and cognitive tests (MoCA, DSST, Digital Finger     Tapping) administered by the nurses who give guidance on cannabis according to the patient's     language (Hebrew, Russian or Arabic). The nurses will have a short guidance course on how to     do cognitive tests and a monthly meeting with a neuropsychologist to test the quality of the     cognitive tests. The questionnaires and cognitive tests will be done on the day of entering     the study (T0) and after 3 (T3) and 6 months (T6). The patients will be asked not to use     cannabis in the 12 hours before the interviews after 3 and 6 months.      Sample size: The sample size was built to show a difference of 1.1 points in the MoCA test     (half the SD for the normal population) between two groups after three months of cannabis     use. The number of patients needed with a power of 80%, β≤0.05 and SD=3.1 (the SD for mild     cognitive impairment in the MoCA test) is calculated at 42 patients in each group (total 84     patients). Due to an expected drop-out of 20%, the number of patients to be included in the     study is 101.   "
99506|NCT01982708|"     The study hypothesis is a haptic sensor can aid in the evaluation of the acute abdomen.     Investigators from the MSU Department of Surgery in Collaboration with MSU Engineering are     assessing the ability of a non invasive, optical device that is placed on a patients abdomen     (much like an ultrasound transducer) to evaluate a patient with an acute abdominal     presentation. Conditions such as appendicitis, cholecystitis, diverticulitis or small bowel     obstruction will be examined with the haptic device. Data will be collected by the device and     later compared to the abdominal findings recorded from an examination conducted by the     principle investigator who is a surgeon. The surgeon will not have acess to data collected by     the haptic sensor and therefore it will have no impact on the decision making process in the     care of the patient. The impact on the individual patient will require obtaining a consent to     participate in the study, a few minutes to place the device gently on the abdomen and collect     the sensor data. There is no direct benefit to the patient by participating in the study. The     potential for such a study may be to develop the technology to have a device that non-medical     staff can use to collect patient data and transmit that data to a healthcare provider at     another location.   "
99554|NCT01983215|"     The purpose of the study is to determine the effects of Prevena therapy on decreasing groin     surgical site infections in patients who are obese and /or diabetic having vascular surgery.   "
99555|NCT01983202|"     The aim of the study is to investigate body composition in newborn children of women with     PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.   "
99556|NCT01983189|"     This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS)     for subjects with autism spectrum disorders, specially targeting repetitive behaviors.   "
100073|NCT01976260|"     The purpose of this study is to compare the effectiveness of the ePrime fractional     radiofrequency system to the 1550-nm fractional photothermolysis system (Fraxel) in the     ability to improve acne scar appearance.   "
99507|NCT01982695|"     This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the     treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be     effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the     onset and progression of left ventricle dysfunction in children with DMD. Multiple studies     show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular     dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved     for patients in whom heart failure is not adequately treated or where side effects preclude     the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug     because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse.     Considering that both skeletal and cardiac muscles are major contributors of the disability     of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need     consideration as the drug of choice for the cardiomyopathic DMD patient.   "
99508|NCT01982682|"     This phase II trial studies how well total-body irradiation, donor lymphocyte infusion, and     cyclophosphamide before donor stem cell transplant works in treating patients with high-risk     hematologic malignancies. Giving total-body irradiation, donor lymphocyte infusion, and     chemotherapy before a donor stem cell transplant helps stop the growth of cancer and abnormal     cells and helps stop the patient's immune system from rejecting the donor's stem cells. When     certain stem cells from a donor are infused into the patient they may help the patient's bone     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the     transplanted cells from a donor can make an immune response against the body's normal cells.     Removing the T cells from the donor cells before transplant and giving tacrolimus and     mycophenolate mofetil may stop this from happening.   "
99509|NCT01982669|"     Excess dietary salt intake is closely associated with the development of hypertension and     cardiocerebral vascular diseases. Reduction in high salt intake significantly prevents     hypertension and cardiocerebral events. Currently, few promising method is available to     reduce salt intake in human. This study focus on examining the salty taste in     population-level and exploring whether dietary factors can reduce salt intake through acting     on salty taste.   "
99510|NCT01982656|"     This research study seeks to explore the effects of massage techniques on pain and anxiety     relief among patients with subarachnoid hemorrhages in the ICU setting in comparison to     subarachnoid hemorrhagic patients using standard medical therapy. In addition, our aim is to     decrease the overall medication use to treat pain and anxiety, and to determine the impact of     massage on sleep duration, quality, and breathing. Our goal is to improve and promote comfort     during the ICU stay as well as decrease the need for narcotic medication usage.   "
99511|NCT01982643|"     The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a     combination of extended-release depot naltrexone plus extended-release bupropion as a     potential pharmacotherapy for methamphetamine (MA) use disorder.   "
99512|NCT01982630|"     This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once     daily compared to placebo and another diabetes drug in participants with Type 2 diabetes     mellitus (T2DM).      This study was modified by a protocol amendment to a 2-part trial to further test the safety     and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between     participants with T2DM and healthy participants. An additional cohort of T2DM participants     and a cohort of non-diabetic obese participants have been added.   "
99513|NCT01982617|"     The investigators primary hypothesis was that recipients of the Motivational Interviewing     intervention would be significantly more likely than those assigned to the Psychoeducation     intervention to demonstrate increased readiness to quit smoking at the end of the     intervention and to seek smoking cessation treatment in the one month period following the     intervention. We also predicted that the Psychoeducation intervention would result in greater     improvements in smoking knowledge.   "
99514|NCT01982604|"     A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD     of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.   "
99515|NCT01983722|"     Expanded access to Stiripentol for patients with Dravet Syndrome.   "
99516|NCT01983709|"     The objective of this study is to determine if systemically infused allogeneic bone marrow     derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized     adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators     plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned     prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to     recipient DNA present in patients' explanted prostate specimens. This will be accomplished     via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at     engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.   "
99517|NCT01983696|"     To investigate the effect of low oxygen tension during in vitro culture in terms of embryo     quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection   "
99518|NCT01983683|"     This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin     in subjects with Clostridium difficile-associated diarrhea (CDAD).   "
99557|NCT01983176|"     The aim of this study was to determine the histopathological results of parotid tumors and     postoperative complications after partial superficial or total parotidectomy with facial     nerve dissection and superficial musculoaponeurotic system reconstruction.   "
99558|NCT01983163|"     In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to     ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure     reduction from baseline seizure frequency at 6 months   "
99559|NCT01983150|"     The primary aim of this study will be to determine the effectiveness of a smartphone     delivered app for young adult smokers on quitting smoking.   "
99560|NCT01983137|"     This non-interventional, observational study evaluates the efficacy of Targinact with regard     to pain relief in daily clinical practice in Belgium compared to the previous analgesic     treatment.   "
99561|NCT01983124|"     The purpose of this study is to evaluate the activity of Vemurafenib in combination with     Fotemustine in Patients with unresectable Stage IV melanoma harboring V600 BRAF mutation who     recurred while in treatment with Vemurafenib. In addition the feasibility and safety profile     of prolonging treatment of this drugs combination will be assessed.   "
99519|NCT01983670|"     In individuals with spino-cerebellar atrophy (SCA), the delayed onset of antagonist muscle     firing has been reported to be the cause of hypermetria. Hypermetria is a common deficit in     individuals with spino-cerebellar atrophy SCA when they perform ballistic goal-directed     movement. Based on the previous studies, ballistic goal-directed movements are controlled by     a triphasic pattern of agonistic and antagonistic muscle activation. The origin of the EMG     pattern is a central program, whereas the delayed onset of antagonistic muscle firing has     been reported to be the cause of hypermetria. To develop a therapy method, the difference in     temporal pattern and intensity of supraspinal excitability of agonist and antagonist bursts     between healthy adults and individuals with SCA when performing rapid and slow goal-directed     movements should be further investigated.      Traditional rehabilitations of individuals with cerebellum lesion were limited to improve the     functional performance of movement. Since the deficits of the goal-directed movement are at     pre-movement programming, only feedforward training will be possible to re-establish an     appropriate program.      Previous showed that peripheral stimulation resulted in a facilitation of motor cortex. Our     group also found that this facilitation in individuals with SCA was similar to the ones     without SCA. Therefore, it is possible to adjust the control pattern of supraspinal     excitability of agonist and antagonist busts of SCA patient with passively providing     electrical stimulation contains normal control pattern of healthy human.      The present study sought to investigate the difference in temporal pattern and intensity of     supraspinal excitability of agonist and antagonist bursts between healthy adults and     individuals with SCA when performing rapid and slow goal-directed movements.   "
99520|NCT01983657|"     The purpose of this study is to establish an efficient and economic treatment scheme by     evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of     similar injection after whole lung lavage , in patients with PAP.   "
99521|NCT01983644|"     Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic     stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent     retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel     occlusion.   "
99522|NCT01983631|"     The Cerebellum contains ten percent of the total volume of the brain and receives brain,     spinal cord and vestibular sensory input. The organization of vestibular and somato-sensory     afferent informations are also reported to be impaired in patients with cerebellum     dysfunctions. Ataxia and impaired balance control are common symptoms in individuals with     spinocerebellar ataxia (SCA). Previous studies have shown that patient with cerebellar damage     are usually agonist and antagonist muscle coordination problem. Past studies also found the     regulation of reciprocal Ia inhibition was impaired in patients with spinaocerebellar ataxia.     In chronic phase, weakness might be developed due to deconditioned. All deficits mentioned     above might lead to a decrease functional ability. Therefore, increasing somato-sensory and     vestibular input, normalizing the modulation of recriprocal inhibition, and improve muscle     strength might be able to improve the functional abilities of individuals with SCA.      Recently, whole body vibration (WBV) has been trained for health groups. Studies showed that     WBV training were able to improve muscle strength, balance control, and functional ability.     However, there is no evidence showed that whether the whole body vibration training can     affect the brain and spinal cord for the regulation of neural circuits. Whether also can     affect for maximal voluntary contraction and improve central fatigue. No previous studies     that whole body vibration training for SCA.      Therefore, the purpose of this research was to investigate the intracortical facilitation and     inhibition, reciprocal Ia inhibition, low frequency depression, maximal voluntary     contraction, interpolated twitch technique to compare the different between the SCA and     health subject. Also to investigate the short term and long term effect of WBV.   "
99523|NCT01983618|"     Beachchair position is used by many orthopaedic surgeons for shoulder surgery. Most patients     undergoing surgery in this position have no complications. However, reported cases of     postoperative neurological deficits have highlighted the risk of cerebral and spinal cord     ischemia. The etiology of such complications remains unclear. The most plausible explanation     for these events would be intraoperative hypotension followed by cerebral hypoperfusion.      General anesthesia is commonly used for shoulder surgery in conjunction with interscalene     brachial plexus blockade. During the block, local anesthetic's spread is frequently observed     leading to a block of sympathetic fibres. Since all nerves located in the head and neck area     go through the stellate ganglion, its block will cause a sympathetic denervation and a     decrease of the peripheral vascular resistance, thus increasing the circulation in cerebral     blood vessels. In normal situations, there is a vasoconstriction of the cerebral blood     vessels in response to a sympathetic stimulation and a vasodilation if sympathetic fibres are     blocked.      Transcranial Doppler (TCD) is a non-invasive examination that provides a reliable evaluation     of intracranial blood flow in real-time. It can help to detect sudden changes in perfusion     and identify potential embolic events. Some studies using TCD have shown an increased     ipsilateral cerebral blood flow (CBF) secondary to a reduced vascular tone associated with a     stellate ganglion block. Others have shown a reduction of contralateral CBF that could     theoretically increase the risk of ischemia in the affected area.      This study will assess the role of interscalene nerve blockade in the protection of cerebral     ischemia and preservation of cerebral autoregulation. This study will also aim to identify     changes in contralateral CBF.      The investigators hypothesize that:        1. Interscalene nerve block will increase CBF        2. Interscalene nerve block will not decrease contralateral CBF        3. Cerebral autoregulation will be preserved under general anesthesia in conjunction with          an interscalene nerve block in this setting.   "
99524|NCT01983605|"     Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the     left atrial appendage in 100 patients.   "
99525|NCT01983592|"     Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients     and there are very few conventional therapies which can address the symptom of fatigue in     patients who are undergoing cancer treatment.      This study will be testing whether the administration of a complementary therapy     (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and     whether this treatment can lessen the fatigue symptoms of adults. The study will also test     whether the n-of-1 study design is feasible in this population.   "
99551|NCT01983254|"     Patients who receive life support in intensive care units commonly suffer from persistent     depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We     are trying to learn which is a better way to manage this distress: a telephone-based adaptive     coping skills training program or an educational program.   "
99552|NCT01983241|"     This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess     the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156     weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of     efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered     weekly by IV infusion for 156 weeks. The study consists of a Screening Phase, a 156-week     Treatment Phase, and an End of Study Visit at Week 160.   "
99526|NCT01983579|"     This is a prospective, open label study assessing the 24-hour IOP patterns using TF in     patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related     macular degeneration). The study will be proposed to patients with AMD and patients with AMD     and concomitant open angle glaucoma (OAG).      The study will be conducted in two stages. In both stages, patients will remain ambulatory     and will be encouraged to follow a schedule as close to their usual lifestyle as possible,     with the exception of particular activities such as caffeine intake, playing wind     instruments, yoga and strenuous exercise. A patient diary will be distributed for the capture     of patient activities during the TF pattern recording. Upon completion of each session, the     CLS (contact lens sensor) will be removed and a final ophthalmic examination will be     conducted.      In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal     range and no concomitant glaucoma will be recruited. After having signed and dated the     patient informed consent form, patients will undergo an initial ophthalmic examination. One     eye will be selected for the study. If both eyes are eligible, the study eye will be selected     in random manner.      All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at     monthly interval. In the first session (S1) anti-VEGF injection will be carried out according     to the study center standard protocol. For the second 24-hour TF recording session (S2),     patients will be randomly distributed into three groups. Group A, consisting of 5 patients,     will receive anti-VEGF injection with a different anti-VEGF substance as compared to S1.     Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy occlusion     after injection as compared to S1. Finally, group C, including 10 patients, will receive     anti-VEGF in a different dose (injection volume) as compared to S1. The randomization ratio     between groups A, B and C is 1:1:2.      The overall study duration for an eligible patient in the first stage of this study is     limited to 5 weeks.      If in the first stage of this study an injection protocol is identified that provokes     significantly lesser elevation on the TF pattern, the alternative injection protocol will be     evaluated against the current standard protocol. For the second stage, 30 patients of whom 15     with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited. After     giving informed consent and confirmation of eligibility, all patients will receive two     24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF     injection according to the standard and alternative protocol will be carried out in random     sequence.      The overall study duration for a patient in the second stage of the study is limited to 5     weeks.      The study has been planned to recruit 20 eligible patients in the first stage within 12 weeks     from the date of initiation. The second stage will recruit 30 patients within 16 weeks. Hence     the overall study duration from the first patient accrued into the study until last patient     out equates to about 33 weeks. Allowing for a database lock within 4 weeks of study     completion, a preliminary statistical report on the primary efficacy endpoint is foreseen     within 2 weeks thereafter.   "
99527|NCT01983566|"     The purpose of this trial is to investigate the effect of food with different fat content and     of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative     bioavailability of deleobuvir.   "
99528|NCT01983553|"     The purpose of this study is to conduct a passive surveillance of hospitalized dengue cases     in subjects who participated in study CYD23 (NCT00842530).      The Objectives are:        -  To describe the incidence of virologically-confirmed hospitalized dengue cases.        -  To characterize hospitalized dengue cases.        -  To evaluate the occurrence of related and fatal serious adverse events (SAEs).   "
99529|NCT01983540|"     This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722)     and booster vaccination in Study A3L27 (NCT01444781).      Study Objective:        -  To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a          3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7)          +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of          age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix          hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.      Observational Objectives:        -  To describe the long-term antibody persistence by group and by stratification on the age          at inclusion of the A3L27 booster study.        -  To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1,          2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes (4          vs 5 doses of poliovirus administered).   "
99530|NCT01983527|"     Arthrographic distention of the shoulder joint is an increasingly popular treatment option in     the management of patients with frozen shoulder. Most have included the intra-articular     injection of a corticosteroid as part of the procedure, but it is not known if this is     necessary. It is also not known whether arthrographic distention using steroid and saline is     better than intra-articular steroid injection alone.      The purpose of this study is to determine whether there is an additional benefit in the     combination of arthrographic distention plus intra-articular corticosteroid injection     compared to arthrographic distention or intra-articular corticosteroid injection alone.   "
99531|NCT01983514|"     Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate     lactation in breastfeeding women. The intranasal administration of OT has recently attracted     attention as a potential novel treatment in several psychiatric disorders including autism.     However, given the anatomy of the nasal cavity, the current design of nasal sprays would be     expected to provide an inadequate delivery of medication to the areas of the nasal cavity     where direct transport into the brain via the olfactory nerve could potentially occur.     OptiNose has developed an intranasal delivery device that provides improved reproducibility     of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity     where the olfactory nerve innervates the nasal cavity.      The primary objective of this study is to identify any differences between single dose 8 or     24 international units (IU) oxytocin delivered intranasally with the optimised OptiNose     device and 1 IU oxytocin administered as slow intravenous infusion in healthy volunteers.     This will be measured in terms of brain activity as measured with functional magnetic     resonance imaging (fMRI), performance on cognitive tests, and physiological markers.   "
99532|NCT01983501|"     The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended     dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with     ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.   "
99533|NCT01983488|"     This study is aimed at investigating the long term clinical outcome of patients with uveitis.   "
99534|NCT01983475|"     Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and     dramatic. After depletion of bone mass and the loss of architectural integrity, it may be     difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative     new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal     osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related     event to a greater extent than that with bisphosphonate administration. In persons with     complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the     knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL     therapy appears to be more potent than bisphosphonates in animal models of bone loss due to     immobilization, suggesting that treatment with denosumab may prove to be an efficacious     therapy for persons with acute SCI to preserve bone mass and strength.   "
99586|NCT01982799|"     For patients with a toothache, is pain relief after root canal procedure improved using long     acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate     the effect of long acting local anesthetic with 1 of 4 oral medication groups, on     post-operative endodontic pain.   "
103325|NCT01933646|"     Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to     90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution   "
99535|NCT01983462|"     The purpose of the study is to test the effects of: 1) blocking sympathetic nerve activity     with a drug called clonidine, and 2) by blocking a kidney protein called renin, and on blood     vessel function and muscle nerve activity in adults who are obese and have high blood     pressure.      Years 1 and 2: The 1st cohort of subjects will consist of 69 healthy young men and women age     18-79 years who are obese, defined as a body mass index > or = to 30 kg/m2, who have     untreated systolic hypertension (systolic blood pressure > or = to 130 - <180 mmHg- average     of at least 3 measurements 2 min apart after 10 min seated resting position). These 69     subjects will then be randomized to 3 treatment arms: clonidine (0.1 mg/day),     hydrochlorothiazide (25 mg/day) or placebo for 4 weeks in years 1 and 2. All tablets will be     encapsulated by to look identical. Subjects will randomly (1:1:1) receive one of the     following combinations in a double-blind, placebo-controlled design:        1. Oral clonidine (0.1 mg twice/day)        2. Oral hydrochlorothiazide (12.5 mg twice/day)        3. Oral placebo      In addition to 69 healthy young men and women, we will also enroll 15 obese adults with     'normal/optimal' systolic blood pressure (<120mmHg) who will undergo baseline testing only     (Visits 1, 2 and 3).      Years 3 and 4: A 2nd cohort of subjects (n=42) will be randomized to aliskiren (150 mg/day),     hydrochlorothiazide (25 mg/day) or placebo for 4 weeks. All tablets will be encapsulated to     look identical. Subjects will receive one of the following in a randomized, double-blind,     placebo-controlled design:        1. Oral Aliskiren(150 mg/day- once per day)        2. Oral Hydrochlorothiazide (12.5 mg twice/day)        3. Oral placebo   "
99536|NCT01983449|"     To assess the safety and effectiveness of adventitial deposition of the Study Drug in     reducing inflammation and restenosis in patients with clinical evidence of claudication or     critical limb ischemia and an angiographically significant lesion in the superficial femoral     and/or popliteal arteries.      Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute     contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel     treatment length.   "
99537|NCT01983436|"     Orthognathic surgery aims to standardize position of the maxilla and the mandible and     therefore chewing, breathing, phonation and swallowing functions. In postoperative, several     physical and functional consequences are observed in patients: transient edema of the face,     maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain     and sensory disturbances (labial or/and chin paresthesias).      Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease     of postoperative edema, improved postoperative comfort and mental well-being.      The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic     drainage to reduce postoperative edema.   "
99538|NCT01983423|"     Animal and clinical studies have suggested that local tissue trauma can promote the process     of an embryo implanting in the uterine cavity. The clinical studies have been performed in     patients with a history of previously failed treatments using in vitro fertilization; a     process of stimulating many eggs from a women and removing them from the body, to allow     fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced into     the uterine cavity.      This study questions whether endometrial biopsy (placing a small straw like catheter through     the cervix and into the uterine cavity to take a sample of tissue via suction into the bore     of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will     improve pregnancy outcome for patients in the first or second cycle of treatment. The     hypothesis is that endometrial biopsy will improve pregnancy outcome.      The study is a randomized multicentre study involving 3 Canadian fertility centres.   "
99539|NCT01983410|"     The purpose of this study is to better understand why pancreatic cancer develops in some     people who are known carriers of the gene mutation (an abnormality) called BRCA, or its close     relative PALB2. The investigators hope to do this by establishing a BRCA/PALB2 mutation     carriers Pancreatic Ductal Adenocarcinoma (the common form of pancreatic cancer) Registry. A     registry is a database of information.   "
99540|NCT01983397|"     The purpose of this study is to compare the effects of different trainings on cognition and     physical performances in elderly over 80 years.   "
99541|NCT01983384|"     There is recent, but limited evidence to suggest that anesthetic depth is associated with     poor postoperative cognitive outcomes. Specifically, several studies suggest that deeper     level of anesthesia is associated with increased incidence of postoperative delirium and     longer-term cognitive decline. In fact, some suggest that older patients undergoing surgery     should routinely be monitored with an anesthetic depth monitor to allow the titration of     anesthetics or sedation medications to lighter levels to promote better postoperative     cognitive outcomes. However, such a practice has never been validated or proven to be     feasible or safe. Accordingly, the investigators plan an exploratory study to determine the     feasibility and safety of randomizing patients undergoing major surgery to receive deep vs.     light anesthetic levels during surgery.   "
99542|NCT01983371|"     The purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced MRI     in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal     cancer.   "
99543|NCT01983358|"     The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in     healthy male subjects.   "
99544|NCT01983345|"     The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a     correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a     measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one     corresponding to the anatomical defect (as defined by the last upper normal vertebra before     the defect).      The purpose of this study is to introduce in France an innovative technique for prenatal     repair of myelomeningocele until now developed only on the American continent.   "
99545|NCT01983332|"     The purpose of this study is to examine the impact of an introduction to the occupation-based     theory (MOHO) on the clinical reasoning of therapists working with cancer clients.   "
99546|NCT01983319|"     The aim of this study is to determine whether noninvasive brain stimulation in form of active     transcranial direct current stimulation (tDCS) combined with constraint induced movement     therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in     patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more     than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.   "
99563|NCT01983098|"     Colorectal cancer (CRC) is the third of the most common cancers and the second leading cause     of cancer death in western countries. CRC is diagnosed at metastatic stage in approximately     35% of cases, while about 20% to 50% of patients diagnosed at earlier stage (stage II and     III) will develop distant metastasis subsequently. Treatment efficacy is usually evaluated by     computer tomography (CT) scan with RECIST criteria and dosage of carcinoembryonic antigen     (CEA) and carbohydrate antigen (CA) 19-9, which were performed every two weeks during the     chemotherapy. The management of treatment for metastatic CRC need the development of early     biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early     chemotherapy resistance. In this prospective study, the investigators will compare the     monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria     and the blood level of CEA and CA 19-9. The investigators carried out a microfluidic digital     polymerase-chain-reaction (PCR) assay to measure the specific somatic genomic alterations in     plasma to identify the circulating tumor DNA.   "
99564|NCT01983085|"     This is a study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing     on superficial partial thickness (SPT) wounds. Nitric oxide has a range of effects on the     body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 160     patient, randomised, controlled clinical study will assess the ability of a simple 2 part,     NOx generating dressing to improve healing in SPT burn wounds and SPT skin graft donor site     wounds compared to standard of care.   "
99565|NCT01983072|"     The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota     balance. Together, the prebiotic solution in combination with the probiotic is expected to     harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates     and to allow a greater diversity of Bifidobacteria species in comparison with a formula     non-supplemented with pre and probiotics.   "
99566|NCT01983059|"     The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at     collecting clinical data, patient reported outcomes and biological samples of all patients     who have been newly and previously diagnosed with liver venous thrombosis in one of the     participating hospitals in-and out-patients clinics of the participating centers in     Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are     currently being treated in one of the participating centers, will be asked to participate in     the study.   "
99587|NCT01982786|"     This research is being done because investigators involved in this study would like to     compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy     boost to see which treatment is better and what the side effects of treatment are.   "
99589|NCT01982591|"     This research trial studies heavy metal exposure in predicting peripheral neuropathy in     patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood     and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may     help doctors find out whether side effects from chemotherapy are related to heavy metal     exposure.   "
99606|NCT01982357|"     Alterations to microvascular blood flow in premature infants, are known to contribute to     several major disease entities.      The optically-measured tissue blood flow, to determine tissue perfusion that can be use to     detect blood loss.   "
99646|NCT01981837|"     The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and     exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR)     Cardiac Amyloidosis.   "
116076|NCT01766518|"     Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients   "
99567|NCT01983046|"     Gut microbiota is being increasingly recognized as an important factor in fat distribution,     insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota     could play an important role in the development of obesity and type 2 diabetes mellitus. The     role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by     microbial fermentation of fiber, is still controversial. One study found that an increase in     the formation of SCFA stimulated energy extraction from diet, with subsequent weight gain. In     contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in SCFA     formation, had beneficial effects on body weight control and insulin sensitivity. Of note, a     study showed that butyrate supplementation in mice prevented diet-induced obesity and insulin     resistance. At the present time, our understanding of the effects of SCFA on human metabolism     (in gut or systemically) is still limited. Yet, in light of the health claims of certain     dietary fibers (prebiotics), a detailed picture of the physiology of human SCFA metabolism     and its interaction with the microbiome is of pivotal importance. We hypothesize that the     differential availability of SCFA impacts human metabolism differently. To determine whether     rectal administration of SCFA is a good model for studying the metabolic effects of SCFA we     first have performed a pilot study (METC 11-3-079). In this pilot study we have determined if     rectal administration of sodium acetate has the same effects on substrate and energy     metabolism compared to proximal administration. Our results indicate that the primary outcome     parameter fat oxidation was significantly changed during post-absorptive conditions, when     sodium acetate in a concentration of 180mM was administered in the distal part of the colon.     In contrast, no effect on energy expenditure or substrate oxidation was seen when sodium     acetate was administered in the proximal colon. Consequently, the distal part of the colon     seems to be a good model to determine effects of gut-derived SCFA on the human substrate and     energy metabolism. Therefore, we will administer in this study the SCFA rectally by using     enemas. We will administer different combinations of SCFA to healthy, overweight male     volunteers and examine effects on metabolism. This study is an important part of a     Gastrointestinal Health TIFN project (GH003 WP 1.2), which will provide more insight in how     increased availability of a beneficial SCFA mixture might serve as a basis for rational     nutritional strategies in the prevention and treatment of obesity and type 2 diabetes     mellitus. To obtain rational nutritional strategies, a next step in this TIFN project will be     focusing on dietary ingredients modulating intestinal microbiota and subsequent SCFA     production.   "
99568|NCT01983033|"     Repetitive negative thinking (RNT) plays an important role in different psychiatric     disorders, such as depressive and anxiety disorders, complicated grief, posttraumatic stress     disorders, anorexia nervosa. RNT is seen as a vulnerability factor in the onset, duration,     severity and relapse of those disorders. Although there is a lot of theoretical research, it     is unknown if a group training protocol addressing RNT has an additional effect on Treatment     as Usual (TAU) of patients with GAD or Depressive disorder. Our hypothesis is that a training     intervention will show a significant effect on declined RNT activity (measured by PSWQ and     LARRS), reduced identification with worrying/rumination (measured by CFQ-13 and a Visual     Analogue Scale), and reduced scores on metacognitions questionnaire (MCV Dutch version of the     MCQ), when compared to TAU (medication, psychotherapy or a combination of both treatments).     Further we expect that this effect on RNT will not be temporary and the beneficial effects     will remain present over a longer time (9 months). Our third hypothesis claims that reduced     RNT will have an effect on Quality of Life, self-esteem and depressive and anxiety scores     (measured respectively by WHO-QoL, Rosenberg Self Esteem Questionnaire, BDI-II and STAI; all     of them in Dutch version). Fourth hypothesis concerns the effect of the training in the     functioning on a neurobiological level. Here we expect that the beneficial effects of     training on RNT will increase top-down prefrontal (dorsolateral) cortical control over an     overactive bottom-up limbic system. To examine these neurobiological effects, we apply a     multimodal approach where we combine resting state fMRI, structural MRI such as diffuse     tensor imaging (DTI), anterior spin labelling (ASL). Further, in our department we developed     an audio critique task where participants hear different kinds of critique amongst some of     negative valence which will be especially problematic for ruminative patients reflecting     difficulties and differences these top-down/bottom-up processes when compared to a healthy     control group at baseline. Further, we hypothesize that only when coping with RNT is     successful these neuronal processes will normalize. We do not expect changes in the waiting     list group.      To examine these clinical and neuronal effects, people suffering from GAD and/or depression     will be allocated by randomisation to an active treatment condition (ATC) and a waiting list     control group (WLC). All the participants will be patients treated by general practitioner,     psychologist or psychiatrist. Training exists of 8 sessions in group (max 12 participants) on     a weekly basis, except for the last session, which takes place after one month). During the     training people will get information on RNT, they will be trained in re-allocation of their     attention, will receive some basic ideas about becoming aware of dysfunctional thinking and     learn coping strategies such as stimulus control and engaging in positive activity.      Assessments will take place before and after treatment for the ATC. The WLC will be measured     at the start of the WLC and 12 weeks later. Measurement takes place by means of     questionnaires and fMRI. During the fMRI, people will undergo a resting state paradigm and     some tasks triggering RNT. 3 and 9 months after the group treatment, participants will be     evaluated again on RNT by means of questionnaires. Participants in WLC will receive group     treatment from the moment the parallel active treatment condition is ended (e.g. after 12     weeks). This group will be evaluated immediately after training and at 3 and 9 months     follow-up.      At the end of the training, after the 8th session, two participants per run will be asked to     cooperate in a qualitative in-depth interview. We are interested in linking results with the     group training with some factors such as quantity of sessions, degree of active participation     in between sessions. We are also interested in defining which interventions are perceived as     most useful and if there is a link between disorder and the usefulness of some interventions.   "
99569|NCT01983020|"     This study has been designed as a controlled clinical trial to evaluate the efficacy of brief     lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when     added to conventional opioid therapy following major spine surgery, as well as to evaluate     the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine     intraoperative neurophysiology during spine surgery in adults and determine whether this     infusion protocol is compatible with intraoperative neurophysiology on spine surgery     patients. If one or more of the approaches is confirmed as efficacious and safe, it could     have a significant impact on the routine management of postoperative pain in this context.   "
99570|NCT01983007|"     Endothelial dysfunction precedes the development of cardiovascular disease and it is common     in patients with diabetes mellitus. The aim of this study is to identify the effect of two     different physical training programs, using ultrasound techniques, on the endothelial     function of patients with type 2 DM.   "
99659|NCT01981668|"     This study utilizes a conventional phase I study design with a '3+3 cohort expansion'     design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2)     Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of     Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent     chemo-radiation are analyzable for the primary endpoint of the study.   "
99571|NCT01982994|"     Observational research has linked physical activity with faster recovery, improved quality of     life, and greater survival; however, little is known about the effects of physical activity     in pre-operative, peri-operative, or post-operative treatment contexts and there is a need     for interventions to improve patient outcomes across the cancer treatment continuum. Three     propositions derived from basic research, epidemiological evidence, and clinical practice     informed our intervention development efforts: (1) Patient outcomes will be enhanced by     interventions that increase physical activity (i.e., standing, walking) across the cancer     treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing     sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure)     will enhance patient outcomes both by increasing physical activity and by stimulating     additional adaptive physiological responses to reduced sedentary time (responses which are     independent of physical activity-induced responses). (3) Patients with gastrointestinal     cancers often suffer functional limitations that limit their independence and their health     behaviors are strongly influenced by the family environment so interventions that engage     caregivers (e.g., spouses) will be more effective than those that target patients/survivors     alone.   "
99572|NCT01982981|"     Nowadays, it is common to ingest beverages other than plain water, which range from flavored     with a low energy input to others of high input. In Mexico, flavored beverage ingestion is     believed to be displacing plain water; this phenomenon is raising concern in the health     sector, due to the relation between flavored beverage intake and the increase in obesity and,     consequently, chronic diseases.      Up until now, there is no instrument available to characterize the perception of the Mexican     population's well-being, beliefs and knowledge regarding plain water ingestion, nor is there     an instrument capable of quantifying the daily water ingestion.      The purpose of this study is design and validate a questionnaire to identify and evaluate the     perception of well-being (PWBQ) related to plain water consumption in a sample of adult men     and women of the city of Cuernavaca.   "
99573|NCT01982968|"     This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in     subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER)     will slow the decline of forced vital capacity (FVC) over 48 weeks.   "
99574|NCT01982955|"     This is a multi-center, open-label, randomized, Phase 1b/2 trial to determine the recommended     phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS)     of Tepotinib when used in combination with gefitinib in subjects with T790M negative, MET     positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring     epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior     EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization     (Tepotinib/Gefitinib arm versus Chemotherapy arm).   "
99588|NCT01982773|"     A hope box or self soothing kit is a therapeutic tool employed by clinicians with patients     expressing suicidal ideation, significant distress, or otherwise at risk of suicidal or     non-suicidal self harm. A Virtual Hope Box (VHB) takes the common hope box practice and     uses smartphone features to enhance the experience. The rich multimedia features on a     smartphone allow more varied options. Furthermore, these devices are already a common     repository for user-generated and user-preferred media, which will allow for a highly     personalized VHB that is highly portable and always available to a user in distress. We     hypothesize that:        1. Patients in the (VHB) intervention condition will demonstrate pre-post reductions in 1)          severity of suicidal ideation 2) ability to cope with stressors and 3) increases in          perceived reasons for living        2. Patients in the intervention condition will demonstrate greater pre-post reductions in          symptoms of suicidal ideation, ability to cope with stressors, and perceived reasons for          living compared to patients in the (ETAU) control condition.        3. Patients and clinicians will find VHB to be beneficial and its use readily integrated          into practice.   "
123400|NCT01670773|"     This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy     humans.   "
99575|NCT01982942|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study     designed to evaluate the safety, tolerability and activity of ibudilast administered twice     daily over a 96 week period in subjects with primary or secondary progressive multiple     sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or     who are receiving either glatiramer acetate (GA) or interferon beta (IFNβ-1a [Avonex, Rebif]     or IFNβ-1b [Betaseron Etavia]) treatment. Study drug will be administered as an adjunct to     glatiramer or beta interferon treatment. A total of 250 male and female subjects from 21 to     65 years old, inclusive, are planned to be enrolled into two treatment groups. Randomization     of subjects will be stratified by disease status (primary progressive multiple sclerosis or     secondary progressive multiple sclerosis) and immunomodulating therapy status: current use of     immunomodulating therapy or no current use of immunomodulating therapy.      The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96     weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase,     subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment     groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will     be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and     evening).   "
99576|NCT01982929|"     Patients at Mbarara Regional Referral Hospital (MRRH) in Uganda who present for routine     caesarean sections often go without a set post-operative pain control regimen. Due to lack of     established protocols and supplies of essential pain control medications are not reliable,     upwards of 90% of women receive no postoperative pain control. There are regional techniques     that are effective, easy to perform, low risk, and inexpensive. One of these techniques is a     tranversus abdominis plane (TAP) block.      A TAP block is a regional anesthesia technique that provides analgesia to the parietal     peritoneum as well as the skin and muscles of the anterior abdominal wall [1, 3-7]. First     described just over a decade ago, it has undergone modifications in technique, and has been     shown to be useful in providing 12-24 hours of significant post-operative pain relief for a     wide array of surgical procedures [2]. It is best used as the cornerstone of a multi-modal     approach to pain control and combines well with oral and intravenous opioid and non-opioid     medications.      This is a technically straightforward procedure that involves injection of local anesthetic     within the fascial plane located between the two deepest muscle layers (transversus abdominis     and internal oblique muscles) of the lower abdominal wall. Given the simplicity of the TAP     block and its long-lasting diminution in post-operative pain after many abdominal and pelvic     surgeries, the incorporation of TAP blocks into post- caesarean section pain management     should be considered as an achievable and simple remedy to the lack of reliable pain     mediations after surgical delivery at MRRH.      This is a study that examines the efficacy of tranversus abdominis plane (TAP) blocks in     providing post-operative analgesia after caesarean section under spinal anesthesia at Mbarara     Regional Referral Hospital (MRRH) in Uganda, Africa. We will look at the value of TAP blocks     in supplementing a routinely used (when available) post-operative non-opioid oral analgesic     regimen.      Primary Hypothesis:      The administration of a TAP block on completion of caesarean section will decrease the level     of pain as measured by a visual Numerical Rating Score (NRS) at 8, 16 and 24 hours, both at     rest and with movement.      Secondary Hypotheses:        1. The administration of a TAP block on completion of caesarean section will increase the          satisfaction score at 8, 16, and 24 hours; and        2. The administration of a TAP block will decrease or prevent the need for postoperative          nurse- administered pethidine (meperidine) as a rescue medication.      This is a prospective, randomized, double-blind, sham controlled, single-center trial. A     total of 240 patients will be enrolled in the study.      Following completion of the caesarean section, all patient will be screened for enrollment     into the study. Enrollees will be randomly assigned to an arm via a predetermined undisclosed     random number generator that will not be known by the staff at the MRRH. The anesthesiologist     performing the TAP or sham block will be given a sealed envelope with the study arm which the     patient has been randomized.      The study procedure is a TAP block and it will be placed on 50% of the enrollees.      TAP BLOCK:      Physicians who have been fully trained on the performance and potential risks of the     technique will place TAP blocks under ultrasound-guidance. Briefly, under sterile conditions,     ultrasound will be used to identify the targeted abdominal fascial plane. Once located, a     predetermined amount of local anesthetic will be injected. This will be performed,     bilaterally. The patient will be monitored during the block and for 30 minutes to follow.      SHAM BLOCK:      Sham blocks will consist of a non-invasive ultrasound scan over the abdomen. To mimic the     injection of medicine, a dull/blunt object will be gently pressed on either side of the     abdomen. The patient will be monitored during the sham block and for 30 minutes to follow.   "
99577|NCT01982916|"     The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean     patients with AGR tablet.   "
99578|NCT01982903|"     The purpose of this study is to determine whether urinary connective tissue growth factor     (uCTGF) can predict the onset of fibrosis in transplanted kidneys.   "
99579|NCT01982890|"     The Investigators have established a cohort of patients with recent-onset inflammatory     arthritis called Early Undifferentiated PolyArthritis (EUPA). This cohort was established to     define novel biomarkers of poor outcomes. We want to study telomere length and T-cell     Receptor Excision Circles (TREC) numbers in peripheral blood as new biomarkers.      This cohort of normal controls was established to be able to define the stability over short     periods of time of telomere length and TREC numbers in normal individuals, in order to     compare with arthritis patients.   "
99580|NCT01982877|"     The purpose of this study is to test the effectiveness of a multi-faceted communication     intervention for family members of critically ill patients to reduce the family members'     long-term symptoms of depression and anxiety.   "
99581|NCT01982864|"     Aminoglycosides are widely used for the treatment of Gram-negative bacilli and Staphylococcus     aureus infections because of their effectiveness and low cost. Nevertheless, many aspects of     their optimal use in hemodialysis patients remain unsolved and little is known about their     pharmacokinetics in this context. The current practice for prescribing aminoglycosides to     these particular patients consists in giving after each hemodialysis session about half the     dose usually given to patients with normal renal function.      However, theoretical considerations and emerging clinical data suggest that this may not be     the most beneficial dosing regimen as efficient peak concentrations are often not attained     and the occurrence of ototoxicity and nephrotoxicity is still frequent.   "
99582|NCT01982851|"     The purpose of this study is to determine if there is a difference in the duration of the     first stage of labor in nulliparous women scheduled for an induction of labor, with whom     analgesia is maintained with a combined spinal epidural (CSE) technique versus an epidural de     novo technique. The investigators hypothesize that the duration of the first stage of labor     will be no different in nulliparous patients who receive either intrathecal fentanyl or     intrathecal fentanyl and bupivacaine, as part of a CSE technique. However, the duration of     the first stage of labor will be shorter in parturients who receive intrathecal analgesia (as     part of a CSE technique) compared to those who receive an epidural de novo technique with     fentanyl and bupivacaine.   "
99583|NCT01982838|"     The purpose of this study is to determine if there is a difference in the duration of the     first stage of labor in nulliparous women in spontaneous labor with whom analgesia is     maintained with a combined spinal epidural (CSE) technique versus nulliparous women in     spontaneous labor with whom an epidural de novo technique is utilized. The investigators     hypothesize that the duration of the first stage of labor will be no different in nulliparous     patients who receive either intrathecal fentanyl or intrathecal fentanyl and bupivacaine, as     part of a CSE technique. However, the duration of the first stage of labor will be shorter in     parturients who receive intrathecal analgesia (as part of a CSE technique) compared to those     who receive an epidural de novo technique with fentanyl and bupivacaine.   "
99584|NCT01982825|"     Tobacco use is the leading cause of cancer death in the U.S. Because smokers who quit by age     30 have cancer death risk similar to non-smokers, promoting cessation early in life is     critical. U.S. colleges/universities, enrolling >14 million students/year (40% of those aged     18 to 24), are an important venue to reach young adult smokers. While daily tobacco use in     the U.S. has declined to 18.1%, nondaily smoking (smoking on some days but not every day) is     increasing, particularly among young adults and African Americans. Moreover, young smokers     and nondaily smokers (half of young adult smokers), respectively, are less likely to seek     help in quitting; thus, innovative strategies are needed to assist cessation early in life,     particularly among those who may not be motivated to quit or seek help. Unfortunately, no     research has focused on developing a cessation intervention that addresses a broad range of     smoking patterns (nondaily to daily smoking) or diverse campus settings among ethnically     diverse student populations. Web-based interventions offer promise in helping college     students to quit, given high rates of Internet use and web capacity to provide tailored     cessation messages. A novel approach to delivering cessation information via the web might be     to address broader lifestyle issues and apply market research strategies to identify market     segments of smokers (groups of people with similar interests, goals, values) in order to     target and engage these groups more effectively. Applying this strategy to an online     cessation intervention should enhance both intervention use and processing of intervention     messages, leading to greater abstinence rates. The investigators aim to: (1) develop and     refine a tailored web-based intervention for smoking cessation targeting college students     with a range of smoking levels; (2) test the usability, acceptability, and feasibility of the     intervention among college student smokers; and (3) determine the potential effect of the     intervention on smoking cessation, smoking level, quit attempts, and contextual factors.   "
99585|NCT01982812|"     Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%     and leaving one third of survivors with long term neurologic and psychiatric sequelae.     Seizures occur commonly with CM and are associated with an increased risk of death and     neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral     levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy     studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity     of pediatric CM.   "
99789|NCT01979965|"     The purpose of this study is to find out whether mitral regurgitation (or a leaky heart     valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve     after administration of ranolazine.   "
99590|NCT01982578|"     Genistein is an isoflavone that has antioxidant and neuroprotective effects on Alzheimer's     disease (AD).      A few years ago our group reported that genistein increased PPARg (peroxisome proliferator     activated receptor gamma) levels. By the way, activation of retinoid X receptor (RXR)-PPARg     dimer, will make overexpressing apolipoprotein E (apoE), which mediates the degradation of     amyloid beta (AB). Therefore, we believe that if this phytoestrogen administration increases     the availability of the transcription factor, it can increase apoE, and also AB degradation.      The main aim of this study is to determinate the effect of 60 mg BID of genistein     administration, during 180 days, compared to placebo group, in AD patients.   "
99591|NCT01982565|"     This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating     dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the     body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 140     patient, randomised, controlled clinical study will assess the ability of a simple 2 part,     NOx generating dressing to increase blood flow in DFUs and to improve healing in chronic DFUs     compared to standard of care.   "
99592|NCT01982552|"     The purpose of this study is to document quality of life, patient satisfaction, effect on     itching, and control of psoriasis vulgaris associated with use of calcipotriene/betamethasone     dipropionate (Taclonex®) topical suspension 0.005% / 0.064% for treatment of plaque psoriasis     under real-life conditions.   "
99593|NCT01982539|"     As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is     to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.   "
99594|NCT01982526|"     Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti     mullerian hormone is recent marker for ovarian reserve. The investigators are searching     ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma     patient who are operated for their cysts.   "
99744|NCT01980550|"     Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by     only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes     for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of     sublingual nicotine tablets (SNT) for smoking cessation and the association of     catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial     among Chinese smokers.   "
99595|NCT01982513|"     Cardiac arrest during pregnancy is rare but may result in poor maternal and fetal outcome.     Because of its rare occurrence and ethical issues this topic is not very well studied and     many questions pertaining to maternal resuscitation remain unanswered. One of the challenging     aspects of cardiopulmonary resuscitation in a term pregnant patient is the ideal positioning     during chest compressions. International societies have made recommendations regarding     management of pregnant patients during cardiac arrest. They advocate the use of left lateral     position with 30 degrees tilt or manual uterine displacement. However these recommendations     are not based on high level of evidence. Ultrasound has been used to visualize the change in     diameter of great vessels to determine the volume status or adequacy of blood circulation of     these patients. This approach can be used to study the adequacy of blood circulation of     pregnant patients in different positions. The objective of this study is to compare the     change in Inferior vena cava diameter obtained with pregnant women in either the left lateral     tilt or in the supine position with a manual uterine displacement, compared to the left     lateral position and the supine position.      Our hypothesis is that the inferior vena cava diameter obtained in the supine position with     manual left uterine displacement would be larger as compared to that obtained with women     positioned with a 30-degree tilt.   "
99596|NCT01982500|"     Investigators propose to assess,the safety and tolerability profile (number of participants     with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line     treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal     carcinoma   "
99597|NCT01982487|"     This partially randomized phase I/IIb trial studies the side effects vaccine therapy and     indoleamine 2,3-dioxygenase (IDO1) inhibitor 4-amino-1,2,5-oxadizaole-3-carboximidamide     (INCB024360) and to see how well they work in treating patients with epithelial ovarian,     fallopian tube, or primary peritoneal cancer who are in remission. Vaccines made from     gene-modified virus may help the body build an effective immune response to kill tumor cells.     IDO1 inhibitor INCB024360 may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving vaccine therapy with IDO1 inhibitor INCB024360 may be an     effective treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.   "
99598|NCT01982474|"     The purpose of this study is to determine safety of allergy immunotherapy lymph node     injections for grass pollen allergies.   "
99599|NCT01982461|"     The objective of this trial is to assess the efficacy of reducing plasma low-density     lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg     and Crestor 10mg F.C. Tablets in hypercholesterolemia population.   "
99600|NCT01982448|"     This research study is evaluating how well triple negative breast cancer responds to     preoperative treatment with Cisplatin or Paclitaxel chemotherapy, and if use of a research     test Homologous Recombination Deficiency (HRD) assay can predict response to preoperative     treatment.   "
99601|NCT01982435|"     The primary objective of the study is to assess the ocular and systemic adverse events of     ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with     intravitreal bevacizumab (Avastin).   "
99602|NCT01982422|"     This is a study evaluating the relationship between prenatal nutrition and neural development     in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD). We are     hypothesizing that women randomized to a whole food, nutrient-dense diet during their 3rd     trimester of pregnancy will have infants with more advanced neural development as compared to     infants born to mothers receiving standard-of-care treatment.   "
99603|NCT01982409|"     The purpose of this study is to observe the persistence of protection, duration of     protection, safety and breakthrough infection rates afforded by live attenuated varicella     vaccine in children over a 5-year period.   "
99604|NCT01982396|"     Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC     (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD)     with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of     combination antiretroviral therapy.   "
99605|NCT01982383|"     The investigators hypothesis is that using the micropulse laser in patient with Central     Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in     significantly minimizing visual recovery time from this disease as well as potentially     preventing recurrences.   "
103350|NCT01933321|"     Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the     neurodegenerative process and stops the clinical progression of disease.   "
99607|NCT01982344|"     To compare the effect of mini-exchange-room and usual care on physical activity and quality     of life in peritoneal dialysis (PD) patients through a randomized controlled study. A total     of 80 incident CAPD patients with age of 18~80 years old will be enrolled, who are medically     stable and regularly followed up. The one group perform traditional PD procedure (G1), and     the other group will utilize disposable mini-exchange-room group (G2). Two groups will be     followed for 6 months. Biochemistry data, types of space for bag exchange, physical activity     and quality of life will also be collected for all subjects at the 3rd and 6th month. During     the study period, peritonitis episode, acute comorbidity and hospitalization will be     recorded. The change of physical activity, quality of life and peritonitis rate will be     compared between the two groups.   "
99608|NCT01982331|"     This is a phase I study to evaluate the safety of a vaccine to protect against influenza     viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of     vaccine or placebo one month apart.   "
99609|NCT01982318|"     The objective of this study is to assess the efficacy and safety of VitroGro® combined with     standard care in the treatment of Venous Leg Ulcers (VLUs) compared to Placebo with standard     care over the course of the 8-week treatment phase.   "
99610|NCT01982305|"     The purpose of this study is to determine whether an ultrasound-guided nerve block simulator     is effective for the training of the axillary block technique.   "
99611|NCT01982292|"     The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic     heart failure.   "
99745|NCT01980537|"     Wire-crossing of a chronic total coronary occlusion (CTO) is time-consuming and limited by     the amount of contrast agent and time of radiation exposure. Magnetic wire navigation might     accelerate wire-crossing by maintaining a coaxial vessel orientation. This study compares     magnetic with conventional wire navigation for recanalization of CTOs.   "
99612|NCT01982279|"     Objectives: The aims were to measure one year change in caloric compensation (CC) and eating     in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating     context and to link these change with individual characteristics (adiposity, age, gender) and     maternal feeding practices.      Three series of measurements of caloric compensation (CC) and eating in the absence of hunger     (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of     measurement was composed of three consecutive weeks an identical lunch was served in four     preschool canteens reaching 236 children. The first lunch was a control session. For the CC     situation (week 2), thirty minutes before the lunch children were offered a preload (137     kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to     palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating     behaviour and feeding practices were measured by questionnaires. Child's height and weight     were measured by a medical doctor.   "
99613|NCT01982266|"     This is a prospective, multicenter, single arm feasibility study of the safety and     performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require     cartilage replacement.   "
99614|NCT01982253|"     To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once     daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled     on diet and exercise alone.   "
99615|NCT01982240|"     The purpose of this study is to confirm that the investigational medication, plecanatide, is     safe and effective in treating chronic idiopathic constipation.   "
99616|NCT01982227|"     Between 30% and 40% of patients with colorectal cancer develop metastatic disease     intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy     but requires resection of all lesions larger than 2mm.      Indocyanine green has an affinity for tumor tissues and the interest of its use has been     demonstrated for the detection of sentinel lymph node and some liver surgeries.      The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been     evaluated.      This study aims to evaluate the diagnostic performance of fluorescence in the detection of     malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological     analysis.   "
99617|NCT01982214|"     A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged     55-75 years, over a 18-month period. The group 1 received a physical intervention, consisting     of whole body vibration (WBV) over 12 months followed by training arrest during 6 months. The     group 2 served as sedentary control. WBV training is performed 2 or 3 times per week, with     each session lasting 20 minutes. The training included light squats at 35-50 Hz and ended up     by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural evaluations will     be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone     micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the     non weight bearing radius.      The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone     exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral     quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA     at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and     trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone     markers will be analyzed longitudinally. The secondary aim is to assess muscle performance     and proprioception. Finally will be assessed markers of cartilage degradation and synthesis,     no study has been published on this tissue.   "
99618|NCT01982201|"     This study will assess the potential effects of calcium carbonate and aluminum/magnesium     hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of     lesinurad in healthy, adult male subjects.   "
99619|NCT01982188|"     This study was designed to evaluate urinary function before and one year after single     incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more     minimally-invasive, single incision sling would provide a similar subjective success rates as     those of retropubic and trans-obturator slings.   "
99620|NCT01982175|"     This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and     safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic     leukemia.   "
99621|NCT01982162|"     Cross-sectional study to characterize cohorts of children with asthma and healthy controls in     terms of clinical features, physiological measurements and non-invasive measurement of     biomarkers and develop phenotype handprints for children with severe asthma   "
99644|NCT01981863|"     It is common practice to use antifibrinolytic agents before and during cardiopulmonary     bypass. They are not without side effects. The investigators want to show that there is no     proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary     bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.   "
99622|NCT01982149|"     Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in     the United States, killing over 160,000 people in 2010, more than breast, colorectal, and     prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung     cancers develop in nonsmokers, it is thought that genetic predisposition plays an important     role. This study proposes to examine the genetic correlation between nasal and bronchial     epithelium and to identify a patient's risk for lung cancer earlier.   "
99623|NCT01982136|"     The analysis of the long-term outcomes and quality-of-life parameters after urethral     reconstruction surgery.   "
99624|NCT01982123|"     This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed     tomography (CT) in measuring lung function in patients with cancer undergoing radiation     therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung     tissue and allow them to plan better treatment.   "
99702|NCT01981096|"     The purpose of this pilot randomized trial is to determine whether the fibromyalgia     integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy     (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM).      Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in     pain intensity than the CBT group at final study assessment (i.e., 3-month follow up).      Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions     in functional disability and depressive symptoms at final study assessment (i.e., 3-month     follow up).   "
99625|NCT01982110|"     Cigarette smoking is the leading cause of preventable death and disability in the world.     Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually.     Additional effective, safe, and accessible treatments for nicotine dependence are needed due     to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side     effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent     evidence supports the central role of craving in maintaining nicotine dependence, and neither     behavioral nor replacement therapies directly target the relationship between cravings and     smoking. Mindfulness therapy has been found to be effective in teaching strategies to     decouple the association between craving and smoking. Mindfulness based smoking therapy (MT)     has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has     recently translated this program into a mobile device application (app) for smoking     cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of     implementation of a MT mobile application in local hospital and community clinics and the     effectiveness of the MT mobile application compared to a National Cancer Institute (NCI)     QuitPal behavioral change group. We will examine smoking results at end of treatment and 2     and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined     to be effective in a mobile phone application, this finding will be a significant step in     providing an additional effective and safe treatment for smokers wishing to quit or cut down     on their intake, and will be especially important in providing treatment options for     marginalized or hard-to-access individuals wishing to reduce cigarette intake.   "
99626|NCT01982097|"     This local, prospective, multicenter, non-interventional study documents observational data     on patients under routine treatment of metastatic RCC with Nexavar before and after     cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive     nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from     Nexavar before cytoreductive nephrectomy.   "
99627|NCT01982084|"     Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in     babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection     die and half of babies with GBS meningitis are left with long term problems with their     development.      Vaccinating pregnant women against GBS in order to protect their newborn babies is a     promising area of research.However, many women are reluctant to accept vaccination during     pregnancy for fear it will harm their unborn child and there is often a lack of understanding     of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive     experience of immunisation against pertussis in the United Kingdom, suggest that antenatal     immunisation can be acceptable.      Previous research has shown that advice from maternity healthcare professionals regarding     vaccination is highly valued by pregnant women so it is also important to explore the     attitudes and opinions of this group.      The objective of this study is to assess the knowledge and attitudes of pregnant women and     maternity healthcare professionals in England and Scotland regarding GBS disease and the     acceptability of a potential vaccine.      There are two parts to this study. The first part will invite pregnant women, maternity     healthcare professionals and parents who have had a child affected by GBS disease to take     part in either a focus group or an individual interview.      This will allow for an in-depth exploration of the participants thoughts and opinions about     GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site     only. The results will guide the development of a self completed, paper questionnaire which     will be distributed to a wider range of pregnant women and maternity healthcare professionals     across four different study sites.      This study has been funded by Meningitis UK. Additional collaborators to those listed include     the charity Group B Strep Support.   "
99628|NCT01982071|"     To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients     with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory     mycosis, gastrointestinal mycosis) in adult patients in China.   "
99629|NCT01982058|"     RATIONALE: Participating in a therapy program may enhance communication and intimacy between     men with prostate cancer and their partners.      PURPOSE: This randomized clinical trial is studying how well therapy enhances communication     and intimacy for men with early stage prostate cancer and for their partners.   "
99630|NCT01982045|"     The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone     graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar     spine, in terms of efficacy and safety.   "
99631|NCT01982032|"     Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients     with severe aortic valve stenosis with similar mid-term success rates as compared to surgery.     Periprosthetic aortic regurgitation (PAR) after TAVR remains an important limitation of this     technique. Moderate to severe PAR occurs in 15-45% of the cases and it is an independent     predictor of mortality after TAVR. Little is known about potential differences in severity of     PAR among different types of aortic valve prosthesis. The current randomized study aims to     evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic     CoreValve® system with main focus on PAR and additional focus on other clinical and imaging     endpoints. Primary objective of this study is to investigate the difference in the severity     of PAR, measured with 3-dimensional transesophageal echocardiography (3DTEE), between     patients undergoing the implantation of the Edwards SAPIEN bioprosthesis versus patients     receiving the Medtronic CoreValve® bioprosthesis. Secondary objectives of this study include:     investigating the value of different imaging modalities in evaluating periprosthetic     regurgitation after TAVR and studying the difference in clinical endpoints according to     VARC-2 definitions and quality of life after TAVR between two available aortic valve     prostheses.   "
99645|NCT01981850|"     PRM-151 is an investigational drug that is being developed for possible use in the treatment     of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body     that makes blood cells, is replaced by fibrosis, or excess scar tissue.      The purpose of this study is to gather information on whether PRM-151 has an effect on the MF     disease, whether it is safe in patients with MF, and how well it is tolerated.   "
99632|NCT01982019|"     The 26RFa was recently discovered in the hypothalamus. In rodents it seems to be related to     glucose metabolism and obesity. However, no data exists in obese patients or in patients with     diabetes. Thus, the investigators planned to dose 26RFa level in obese patients before and     after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The     investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and     in healthy volunteers with normal weight. Comparison of these different groups will permit us     to better understand the 26RFa involvement in glucose concentration regulation and in     obesity.   "
99633|NCT01982006|"     Cataract is the leading cause of blindness worldwide and cataract surgery is the most     frequent surgery performed in France. A new technology, the femtosecond laser-assisted     cataract surgery, has to be compared with phacoemulsification alone, the conventional     cataract surgery, to determine the economic impact of femtosecond laser-assisted process for     the French healthcare insurance.   "
99635|NCT01981980|"     Carboxytherapy (CA) refers to the cutaneous and subcutaneous administration of carbon dioxide     gas [CO2] for therapeutic purposes. Radiofrequency (RF) is a method that uses electric     current to generate heat into the layers of the skin and the subcutaneous tissue. Both     techniques are indicated to the treatment of skin laxity. The aim of this study was to     compare the effects of CA an RF on human skin. Methods: Eight patients who underwent     abdominoplasty surgery received a single procedure of both treatments. Untreated skin was     used as control. In an area of 49 cm2 (7 x 7 cm) in the infra-umbilical region CA was     performed on the right and RF on the left side. Sample collection period ranged from zero to     120 days. CA was administered at a velocity of 40 ml/min, and the total quantity of CO2     infused was approximately 20ml. RF was carried out in a temperature higher than 40ºC on the     epidermis for 5 minutes after reaching this temperature.   "
99636|NCT01981967|"     The aim of this study is to further characterize the safety profile of IMOJEV®.      Primary Objective:        -  To describe serious adverse events (SAEs, including adverse events of special interest          [AESIs]) up to 60 days after administration of one dose of IMOJEV®.      Secondary Objective:        -  To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after          administration of one dose of IMOJEV®.   "
99637|NCT01981954|"     In children with a severe form of spina bifida (which is the consequence of a spinal cord     defect) it can happen that the bladder muscle (detrusor) contracts strongly and without     warning (neurogenic detrusor overactivity) and that the urethra (the passage connecting the     bladder with outside) does not relax. Those children cannot void but urine leakage can happen     when the pressure in the bladder is so high that it overcomes the closed urethra (overflow at     high filling bladder pressure) and/or when an overactive contraction is very strong. The high     bladder pressure before overflow occurs puts those children at risk for kidney damage and the     overactive contractions decrease the quality of the bladder additionally to the fact that     they can cause leakage. Therapy is aimed to decrease the high filling bladder pressure and     the overactive detrusor contractions.      The purpose of this study is to evaluate long term efficacy and safety of treatment with     solifenacin succinate (the study drug) and blood levels of solifenacin succinate (the study     drug) in children with neurogenic detrusor overactivity after multiple dose administration.   "
99638|NCT01981941|"     To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to     severe primary RLS patients with moderate renal impairment and to confirm dosage and     administration in such population.   "
99639|NCT01981928|"     The purpose of the study is to see how safe the study drug is and how well it is tolerated     after dosing. The study will also investigate how the study drug is taken up, metabolized     (chemically broken down), distributed through the body and excreted. A further aim is to look     at how this process is possibly altered by food by giving the study drug in the presence and     absence of meals.   "
99640|NCT01981915|"     Patients with underlying neuromuscular disorder (NMD) often suffer from weakness in the     inspiratory and expiratory muscles. Consequently they do not have the strength to generate     the minimum flow of 160 to 300 liters/minute for an efficient cough function. The restricted     cough function allows secretion to accumulate, which in turn causes narrowing of the airway     lumen and makes ventilation of the neuromuscular patient even more difficult. The patient's     susceptibility to infection increases again and the vicious circle repeats itself. Severe     secretion retention may even lead to ventilator failure. Effective secretion and cough     management instead reduces the risk for stay in hospital. Therefore, secretion and cough     management is a mandatory part of the therapeutic concept for treating patients with     neuromuscular disease.      The therapeutic efficacy of the Lung Insufflation Assist Maneuver(LIA) integrated in the     ventilator VENTIlogic LS-plus manufactured by Weinmann GmbH+Co KG was studied in a pilot     study carried out by the Dep. for Pediatric Pulmonology and Sleep Medicine at the University     Hospital of Essen/Germany in cooperation with Research & Development at Weinmann GmbH &Co KG,     Germany . The objective of the pilot study was to examine the therapeutic efficacy of LIAM as     a cough support function in patients with neuromuscular disease and indications for     mechanical ventilation.      We hypothesized that i) a certain insufflation maneuver pressure may be optimal to achieve     the highest individual peak cough flow and ii) that this pressure is below the pressure     needed to achieve the maximum insufflation capacity. We define the lowest insufflation     capacity at which the best individual PCF can be achieved as optimum insufflation capacity     (OIC). The study was performed using two different techniques in order to demonstrate that     findings are not dependent on maneuver details but are rather based on effects of maneuver     pressure. The protocol was limited to techniques which do not require breath stacking: i)     insufflation with an Intermittend Positive Pressure (IPPB) device and ii) with the VENTIlogic     LS using LIAM.   "
99641|NCT01981902|"     Dehydration can result from exposure to harsh environments including hot and dry desert     climates. Soldiers and non-military workers are frequently required to work in hot, dry     conditions, and dehydration can be productivity limiting and life threatening if     unrecognized.   "
99642|NCT01981889|"     Steroid is commonly used to treat autoimmune disorders such as rheumatoid arthritis, lupus,     and inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis). However, its use is     associated with numerous systemic side-effects, including diabetes, osteoporosis, and     potentially significant mood changes. The investigators wish to determine how common patients     with inflammatory bowel disease experience mood changes when they take steroid for their     disease.   "
99643|NCT01981876|"     Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading     cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal     is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish     effective screening and prevention programs. The investigators hypothesize that asymptomatic     esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is     designed to determine the prevalence of ESD in residents of southwestern Kenya.   "
99660|NCT01981655|"     The objective of this trial to see whether:      -Cardiac performance (cardiac index and secondary outcomes)can be improved in patients with     acute heart failure (AHF) and symptoms and consequences of fluid overload (pulmonary and     interstitial edema) and poor peripheral perfusion can be reduced by:        1. Providing lactate as a substrate(Improve cardiac index)        2. Simultaneously restoring optimal preload      Optimal standard treatment will be achieved in both arms with the use of current best     treatment protocol for AHF as per independent treating physician.      4. To assess effects of 0.5M Na lactate (Totilac) on plasma and urine biological parameters     (sodium, potassium, chloride, pH, bicarb, base excess, albumin)      5. To assess effects of 0.5M Na lactate on morbidity and mortality.   "
99734|NCT01980680|"     After hCG trigger a large amount of exogenous progesterone is used for luteal phase support     in many countries until 10th week of gestation. Instead we suggest the use of two small doses     of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the     endogenous progesterone production from the corpora lutea (CL).   "
99647|NCT01981824|"     One of the most challenging areas currently facing obstetricians is the detection and     management of pregnancies in which the growth of the fetus is poor. These fetuses have not     only increased rates of perinatal morbidity and mortality, but also have higher levels of     morbidity extending into adult life (Linda; Murray 2010).      In developing countries including Egypt, low birth weight is a national concern and     emphasized in population and health policies according to the latest WHO data published in     April 2011 low Birth Weight Deaths in Egypt reached 13,587 or 3.74% of total deaths,     Mortality was more frequent in LBW (31.6%) than normal birth weight (NBW) infants (2.0%).      Fetal growth restriction (FGR) is defined as fetuses whose growth velocity slows down or     stops completely because of inadequate oxygen and nutritional supply or utilization (Linda;     Murray 2010). Low birth weight (LBW) refers to an infant with a birth weight < 2500 g, Small     for gestational age (SGA) birth is defined as an estimated fetal weight (EFW) less than the     10th centile and severe SGA as an EFW less than the 3rd centile, (RCOG Green-top Guideline     No.31, 2013).      Ultrasound has been used as a tool for determining fetal health and a variety of sonographic     parameters have been used to screen and diagnose IUGR including fetal biometry, fetal body     proportions (Campbell et al., 1994), amniotic fluid volume (Owen et al., 1999), subcutaneous     tissue thickness and estimated fetal weight (EFW) (Larciprete et al., 2005).      IUGR is associated with changes in the body proportions as undernourished fetus directs most     of its energy to maintain the growth of vital organs, such as the brain and heart, at the     expense of the liver, muscle and fat and this results in decreased abdominal and thigh     circumference measurements and hence theoretically increased HC/AC, FL/AC and FL/TC ratios     (Colley et al., 1991).      Fetal thigh circumference has a role to play in accurately measuring fetal weight when     incorporated with other fetal parameters and provide a potentially straightforward method for     assessing the deposition of muscle and fat in the growing fetus; there is a scope of using     the FL/TC ratio in predicting IUGR (Sanyal et al., 2012).      Fetal thigh circumference to femur length ratio (FL/TC) seems to be potential for use in     predicting IUGR (Shripad; Varalaxmi, 2005).   "
99648|NCT01981811|"     The purpose of this study is to evaluate adherence to treatment with, and safety and     tolerability of, the medical information device #1 (MIND1) system in subjects with     Schizophrenia or Bipolar I Disorder who are currently treated with oral aripiprazole.   "
99649|NCT01981798|"     To investigated whether an ambulant intervention program with a behavioral therapy approach     would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the     effect on patients with pronounced fear avoidance behavior and/or with psychosocial     limitations was addressed.   "
99650|NCT01981785|"     The immune system is an intricate system comprised of specialized cells, proteins, tissues     and organs. Proper functioning is critical to the body's ability to defend itself against     harmful pathogens. Immunological disorders and deficiencies are defects in the immune system     that lead to abnormal immune responses. Abnormal immune responses could be derived from     immune deficiencies, dysregulations or hypersensitivities.      The overall goal of this research study is to identify the mechanisms of primary immune     deficiencies and immune disorders at the genetic, cellular and molecular level, using novel     analytic techniques to be performed on immune cells derived from blood samples. The knowledge     gained from the aims of this study could lead to better diagnostics and identify novel     targets for therapeutic interventions.   "
99651|NCT01981772|"     The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine     solution for incision and drainage. Ninety patients will be examined clinically to determine     a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and     drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6     ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients     will rate pain prior to and throughout the procedure.   "
99652|NCT01981759|"     This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT     sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to     testing efficacy, this trial will characterize DCS effects in terms of time course and     persistence of response and will examine DCS effects on memory consolidation and cognitive     flexibility as possible mediators of DCS enhancement of CBT for delusions.   "
99653|NCT01981746|"     To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce     the number of subjects with impaired muscle strength following adductor canal block. We     hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps     strength compared with an adductor canal block with 30 ml.   "
99654|NCT01981733|"     The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb     using electrical stimulation. Increases in lower limb blood flow improve venous return and     thereby reduce venous stasis. Since stasis is one of the compounding factors in the     development of deep vein thrombosis, the risk of developing thrombosis should theoretically     be proportionally reduced. This technique may prove to be a useful tool in preventing and     reducing the incidence of deep vein thrombosis in both medical and surgical patients together     with passengers undertaking significant duration travel (as travel - related deep vein     thrombosis is not exclusively related to flying).   "
99655|NCT01981720|"     To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult     Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01     and PB-102-F02. Patients will be enrolled to receive the same dose of PRX-102 (0.2 mg/kg, 1.0     mg/kg, 2.0 mg/kg), as an intravenous infusion every 2 weeks for 24 Months.   "
99656|NCT01981707|"     Until today no current diagnostic tool exists to identify an early objective response when     patients with castration-resistant prostate cancer were treated by abiraterone acetate or     enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait     12 weeks before the first evaluation. To know soon that the treatment is effective will be     decisive for the oncologist, even more in palliative situation where second effects can't be     imposed to patients.      In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new     therapy. Moreover, the investigators suppose that we can assess an early stage if there is an     objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily and     expansive treatment.      The aim of this study is to assess if it is possible to determine early (6 weeks of     treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or     enzalutamide in post-docetaxel.   "
99657|NCT01981694|"     This study will determine the safety and tolerability of PF-06649751 given orally to healthy     volunteers. To determine the optimal dose for future studies, the concentration of the drug     over time will be determined by periodic blood samples. The rate of eye blinks will be     measured as an indicator of PF-06649751 action on the receptors of interest in the brain.   "
99658|NCT01981681|"     PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and     tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque     psoriasis. The goal of the study is to assess the safety, local tolerability, and     pharmacokinetics in healthy subjects.   "
99661|NCT01981642|"     -  Study Purpose: The purpose of this study is to evaluate the sensitivity/specificity of          noninvasive diagnostic methods for the cardiac function that are based on data available          from the Left Ventricular Assist Device (LVAD). These diagnostic methods will be          compared to standard clinical diagnostic procedures both at rest and during exercise.        -  Study Design: The study is a prospective interventional cohort study.        -  Patient cohort: Thirty heart failure patients who had or are about to have a LVAD          implanted.        -  Data Collection: The acquisition of LVAD data (motor current and speed) and wristwatch          accelerometry data concurrently to the documentation of routine clinical examinations,          such as cardiac ultrasound, electrocardiography (ECG), cardiac catheterization, and          exercise tests, will be performed.   "
99662|NCT01981629|"     Currently, bedside ultrasound (US) is performed routinely in emergency department (ED)     patients with undifferentiated shock to help guide resuscitation. Previously, it has never     been possible to measure cardiac output on patients in the ED. Our clinical question looks at     whether the USCOM device gives clinically relevant information in addition to ED cardiac US     in patients with shock.   "
99663|NCT01981616|"     The primary purpose of this study is to determine the rates of seroconversion to a hepatitis     B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo.     Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine     series, assess change in anti-hepatitis B surface antibodies and assess the safety and     tolerability of a single 750-mg IV dose of vedolizumab.   "
99664|NCT01981603|"     Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait     listing and number of transplants. The navigator will provide tailored information and     assistance to help dialysis patients complete the tasks required at each step in the     transplant process. In the control group, dialysis patients will continue to get usual care     from their nephrologists and dialysis facility personnel.      Hypothesis: Compared to control patients, intervention patients will be significantly more     likely to be wait listed or receive a kidney transplant.   "
99665|NCT01981590|"     The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to     evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter     advanced into the great veins.   "
99666|NCT01981577|"     The purpose of this study is to investigate the segregation of the subthalamic nucleus into     its motor and non-motor regions in patients with Parkinson's disease and healthy controls     with the aid of ultra-high field magnetic resonance imaging.   "
99667|NCT01981564|"     Asthma is the number one cause of pediatric emergency department (ED) visits in young     minority children and is responsible for high healthcare costs. The ED is often the point of     contact for many inner city children and many families view the ED as the child's primary     source of asthma care. This study plans to test a new model of asthma care, Asthma Express     (AEx), that includes a follow-up asthma visit in the ED for an asthma check-up , asthma     education, a prescription for preventive asthma medications, an appointment for the child to     see their pediatric provider and a home visit to assist families with environmental control     methods to prevent asthma symptoms.   "
99668|NCT01981551|"     Background:        -  Desmoid tumors (also known as aggressive fibromatosis), are rare, locally invasive,          slow-growing soft-tissue tumors. The disease can be either asymptomatic or be associated          with severe loss of organ function and significant morbidity.        -  Treatment with the selective small-molecule Gamma-secretase inhibitor PF-03084014 caused          significant tumor shrinkage in patients with unresectable desmoid tumors in an early          phase clinical trial.        -  The Notch pathway is a key regulator of cell differentiation, proliferation and          apoptosis; aberrant signaling via the Notch pathway is associated with carcinogenesis.      Objectives:        -  Primary: Determine the response rate (CR+PR) of PF-03084014 in patients with desmoid          tumors/aggressive fibromatosis        -  Secondary: Assess symptom measures at baseline and on study; perform genotyping for          germline and somatic mutations in APC and CTNNB1 genes; correlate clinical response to          therapy with genotyping data; and assess modulation of the Notch pathway by evaluating          notch response genes in tumor biopsies at baseline and after drug administration      Eligibility:        -  Age greater than or equal to18; histologically confirmed desmoid tumor not amenable to          curative resection or definitive radiation therapy that has progressed after receiving          at least one line of standard treatment; adequate organ function        -  Willingness to provide blood samples and 10 unstained slides or a tumor block for          genetic research studies      Study Design:        -  This is an open-label Phase II trial of PF-03084014; study drug will be administered          orally at 150 mg twice a day in 21-day cycles        -  Optional tumor biopsies for research purposes will be performed at baseline prior to          study treatment and at the beginning of cycle 7 (+/- one cycle)        -  Restaging scans (MRI with diffusion weighting) will be performed at baseline, at the end          of cycles 1 and 6, and then every 6 cycles        -  Health-related quality of life (HRQOL)/symptom questionnaires will be administered at          baseline and at each Clinical Center visit   "
99680|NCT01981382|"     This research study will examine whether enhanced pain sensitivity increases the risk of     persistent low back pain. The study will address the highly prevalent and costly condition of     persistent low back pain and a major obstacle for the implementation of clinical strategies     to improve patient outcomes. The knowledge gained from this study may lead to a better     understanding of the biological mechanisms that contribute to persistent low back pain and     will inform future work to develop predictive measures of persistent low back pain risk,     evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to     identify patients who are at increased risk of persistent low back pain.   "
99709|NCT01981005|"     This non-randomized, single group, open-label study will investigate the mass balance, routes     of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the     pharmacokinetics of a 14C-labeled tracer in healthy volunteers   "
99669|NCT01981538|"     Background:      - Caring for a loved one is often stressful. Some studies show it may affect health and     emotions. Researchers want to know more about this but do not know the best way to gather     data. They want to know if an online survey is a good way to gather data from caregivers of     people receiving cancer treatment at the NIH Clinical Center. They want to know if there are     differences among caregivers depending on the type of cancer treatment the family member or     friend is receiving. They want to use this data to improve support programs for caregivers.      Objectives:      - To see if an online study is a good way to get data from caregivers of people with cancer.      Eligibility:      - Adults 18 years old and older who are taking care of a cancer patient at the NIHCC.      Design:        -  The study period begins when the family member or friend begins a new cancer treatment          and continues for 6 months afterward.        -  Participants will complete an online survey 3-4 times. This will include questions about          caregiving, stress, emotions, and spirituality. The survey can be taken anywhere on a          computer. It will take about 30 45 minutes each time.        -  Participants will also answer general questions about themselves and their health. This          will be done over the phone with the study team. It will take 5 minutes.   "
99670|NCT01981525|"     Background:        -  Li Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer          predisposition disorder. Four main cancer types including sarcoma, adrenocortical          carcinoma, breast cancer, and malignant brain tumors commonly characterize LFS but the          syndrome can include other cancers.        -  Metformin is an oral biguanide drug that is approved by the FDA for the treatment of          type II diabetes. Metformin has been associated with reduced cancer risk in several          epidemiologic studies and reduced cancer mortality in patients with type 2 diabetes.        -  Metformin decreases circulating insulin and IGF1, and promotes glucose uptake in          skeletal muscle and inhibits gluconeogenesis in the liver. Elevations in circulating          insulin and IGF1 levels have been associated with increased cancer risk.        -  Preclinical research in animal models shows that metformin may be more toxic in cancer          cells that have lost p53 function.        -  Lifetime risk of cancer in LFS patients with germline TP53 mutations is estimated to be          up to 70% by age 60, with women having excess lifetime cancer risk (up to 100%) compared          to men (up to 80%). There are currently no approved chemopreventive agents for patients          with LFS.        -  Metformin has been shown to be safe and tolerable in diabetic and non-diabetics, and may          be an ideal candidate for chemoprevention of cancer in this population.      Objectives:        -  Determine the tolerability of oral daily metformin in patients with LFS caused by          germline TP53 mutations.        -  Determine if 8 weeks of daily metformin administration has any effect on circulating          IGF-1, insulin, and IGFBP3      Eligibility:        -  Must have a germline TP53 mutation and provide documentation of testing.        -  Must have adequate organ function.        -  Age greater than or equal to 18 years.      Design:        -  This is a pilot study to assess the tolerability of daily oral metformin administration          in patients with LFS caused by germline TP53 mutations and to study the effect of          metformin on biomarker levels in these subjects.        -  In the absence of intolerable toxicity, a minimum of 22 patients will take metformin by          mouth for a total of 14 weeks and then discontinue metformin for 6 weeks. The total time          on study will be 20 weeks.        -  Patients will be assessed for biomarker levels (IGF-1, insulin, IGFBP3) by blood sample          at baseline, and weeks 0 and 8.   "
99671|NCT01981499|"     PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce     vascular permeability. The purpose of this study is to evaluate the safety, tolerability,     pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in     healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.   "
99672|NCT01981486|"     PF-05180999 is a novel phosphodiesterase-2 (PDE2) inhibitor. The purpose of this study is to     evaluate the safety, tolerability, and pharmacokinetics of multiple doses of PF-05180999     administered twice daily over 14 days. Exploratory measures of PDE2 inhibition will also be     evaluated in blood and blister fluid.   "
99673|NCT01981473|"     The purpose of this study is to examine the relationship between anti-drug antibodies, serum     drug concentrations, and clinical response for rheumatoid arthritis patients being treated     with etanercept, adalimumab or infliximab.   "
99674|NCT01981460|"     We are evaluating the effect of methylene blue and visible light activation on the microbiome     of the skin.   "
99675|NCT01981447|"     The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.   "
99676|NCT01981434|"     Technology-Based Obesity Prevention Project (TeBOPP) is a bilingual (English/Spanish)     family-based educational intervention that will use a novel videogame format to educate     underserved inner city Latino children and adolescent patients and their parents about     healthy diet and exercise. To the best of our knowledge this is the first family focused     obesity prevention educational intervention using a gaming scenario where both parents and     children/teens (8-15 years) participate simultaneously. The goals are to improve parent-child     (teen) knowledge regarding healthy food habits and create a change in attitude towards     healthy eating and exercise.      Hypothesis: We hypothesize that game-based avatars (i.e., a graphical representation of an     individual within a virtual space) can create change in knowledge and attitude towards     healthy eating and exercise.   "
99677|NCT01981421|"     Liver fibrosis has been considered as irreversible change. However, recent study showed that     early stage liver fibrosis could be reversible and a lot of new drugs are now developing or     developed including anti-viral treatment. Liver biopsy is considered as golden standard for     the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of 1/50000     of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis     is still challenging. Furthermore, its invasive nature, repeated biopsy is practically almost     impossible. Hence, non-invasive diagnosis of liver fibrosis is important. In this study we     hypothesized that multi-parametric MR imaging including MR elastography, conventional DWI,     and IVIM can predict changes of liver stiffness after anti-viral therapy in patients with     chronic liver disease. We will enroll 60 biopsy-proven patients and perform multi-parametric     MR imaging at the enrollment and one year later to evaluate changes in quantitative values in     MR.   "
99678|NCT01981408|"     This type of study is called a radiolabeled study. For this study, LY2801653 (study drug) has     been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally     occurring radioactive form of the element, carbon. This study will increase understanding     about how the drug appears in the blood, urine, and stool after it is administered to healthy     people. Information about any side effects that may occur will also be collected. This study     will last up to 15 days for each participant, not including screening. Screening is required     within 28 days prior to enrollment.   "
99679|NCT01981395|"     Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a     significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with     placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally     we are going to assess changes in mood/affect and cognitive function of subjects following     administration of fenobam and after cutaneous sensitization compared to baseline.   "
99724|NCT01980810|"     The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are     effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.   "
99681|NCT01981369|"     The study will evaluate the effect of Dexmedetomidine sedation on the duration of     infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All     patients will receive infraclavicular block before the surgery and then they will be     randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory     block will be evaluated in recovery room, 24 and 48 hours after the surgery.      Hypothesis:      Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in     patients scheduled for upper limb surgery.      Secondary: Dexmedetomidine sedation        -  Gives an adequate level of sedation during the surgical procedure        -  Reduces the requirements of postoperative opioids        -  Improves the quality of sleep on the night of the surgery        -  Increases patients satisfaction regarding the anesthesia technique        -  Dexmedetomidine sedation is safe and easy to use        -  Dexmedetomidine sedation provides less respiratory depression during the procedure.   "
100074|NCT01976247|"     The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and     LipoSonix System for fat reduction and improving body shape.   "
99682|NCT01981356|"     There is a substantial need for enhancing the efficacy and effectiveness of Veterans Health     Administration (VHA) inpatient services for psychosis and tailoring them to support recovery.     The proposed pilot study will explore whether Acceptance and Commitment Therapy (ACT), a     recovery-oriented, evidence-based inpatient treatment, is a feasible, acceptable, safe, and     effective adjunct for the inpatient treatment of Veterans with psychosis at a single VHA     site. Additionally, an evaluation of barriers and facilitators to future implementation will     be conducted. If promising, the data gained from the proposed study will support future     evaluation, implementation and dissemination efforts that have the potential to improve     inpatient treatment for psychosis and recovery, and thus, the lives of Veterans, while     reducing costs for VHA.   "
99683|NCT01981343|"     Gallstone formation is multifactorial: immutable risk factors include genetics and ethnicity,     age and being female, and mutable risk factors include obesity, and metabolic syndrome, diet,     rapid weight loss, and other conditions such as cirrhosis, Crohn's disease, irritable bowel     syndrome, gallbladder stasis, and the use of certain drugs like Ceftriazone. Previous studies     have linked serum cholesterol, and low-density lipoprotein cholesterol levels and fatty liver     disease to gallbladder disease. Given betaine's reported beneficial effects on fatty liver     and lipid profile, A-F Betafood® may have a beneficial effect on gallbladder function.      The objective of the study is to assess the effect of A-F Betafood® on gallbladder and liver     function as measured by gallbladder ultrasounds and liver function tests. The hypothesis is     that A-F Betafood® will improve gallbladder and liver function after the 12 week treatment     period.      This is a single-center, randomized, double-blind, placebo-controlled, parallel group study     with two arms. This study will consist of a single 12 week treatment period. The planned     sample size for this study is 50 overweight female subjects, with 25 subjects randomized     equally to each of the two study arms in double-blind manner at a ratio of 1:1   "
99684|NCT01981330|"     This is a pilot-study of 25 selected Swedish patients which all have severe hoarseness or     aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or     possibly hereditary). The patients are operated with phonomicrosurgical dissection of the     scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma     cells, aMSC (which were previously harvested from each patients´s bone marrow, purified,     expanded and characterized according to standard procedure at the Center of Hematology and     Regenerative Medicine Karolinska University Hospital Huddinge). 14 Patients is planned to be     treated with a single injection of aMSC and 11 patients with injection of aMSC mixed with a     carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska     Institute. The laryngeal status, vocal fold function, and voice function will be followed     individually with an advanced battery of examinations performed before and up to 1 year     postoperatively. Side effects and complications are noted and reported during surgery and     following surgery at regular intervals during at least 1 year Since autumn 2015 no new     patients have been recruited and no treatments are given during 2016. The monitoring     authority was changed from Swedish National Board of Health to Swedish Medical Product Agency     (MPA) in March/April 2016. Further inclusions and treatments are postponed until permission     is granted from MPA to continue the study.   "
99685|NCT01981317|"     The purpose of this research study is to determine how well children with OCD can be helped     using therapy that requires less clinic visits. The investigators are testing a Stepped-Care     Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of     parent-led, therapist-guided treatment for OCD. The goal is to see if therapy can be done in     fewer visits to the clinic. Children receiving SC-CBT will start with Step One, which     includes three therapy sessions over six weeks. Those who do not get better in Step One will     STEP UP to Step Two which involves coming in to meet with a therapist for the remaining     sessions. Youth receiving SC-CBT will be compared to youth receiving standard CBT in the     clinic through this study. It is expected that Stepped Care will be an acceptable,     cost-effect, and feasible treatment with outcomes similar to standard CBT.   "
99686|NCT01981304|"     Percutaneous coronary intervention with stenting may induce endothelial damage/dysfunction     and inflammatory reactions, which in turn delay healing and endothelialization and may lead     to the occurrence of major adverse cardiac events (MACE), such as restenosis,     atherosclerosis, and stent thrombosis.      Drugs, platforms and polymers are considered the protagonists of these pathophysiologic     processes.      The objectives of the INERT study is to assess the extent of inflammation and endothelial     damage induced by the first carbonized bio-absorbable coated rapamycin-eluting coronary stent     at time of percutaneous coronary intervention and correlate the extent of these abnormalities     with short and long-term clinical outcome and post-procedural evaluation of success.      As part of the study, a randomized sub-study will be carried out at the Coordinating Center     in order to compare the biohumoral, clinical and procedural findings between patients with     the carbonized bio-absorbable coated rapamycin-eluting coronary stent and those randomly     assigned to receive stents with different platforms and polymers.   "
99687|NCT01981291|"     This study was designed to assess whether the injection of local anesthetic into the nerve     (intraneural), as opposed to around it (perineural), leads to longer anesthesia and analgesia     of the leg.      Some reports of accidental intraneural injection mention an extremely long duration. When     different drugs and doses were evaluated in a clinical trial of intraneural injection, a     longer-than-expected duration was reported.      The investigators will compare the two types of injection using the same drug, so as to     determine if there is an actual difference in duration.   "
99688|NCT01981278|"     The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with     the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg     tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg     prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.   "
99689|NCT01981265|"     This is a case-control study involving one medical center and one research institute to     develop a data-set containing a minimum of 100 osteoarthritis cases, minimum of 100     independent controls of similar gender ratio and a minimum of 100 disease controls (cases     with hip and/or knee OA) to associate DNA sequence (allelic) variations in candidate genes     with osteoarthritis phenotypes.      This study is intended to begin at the Institute of Biomedical Sciences at Academia Sinica     (which includes National Genotyping Center (NGC) and National Clinical Core (NCC)), National     Taiwan University Hospital.   "
99691|NCT01981239|"     It was well known that aspiration is the primary cause of an aspiration pneumonia among the     dysphagia patients.      In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and     fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are     invasive and allowed only in a limited condition.      In this study, as a precedent study for the non-linear analysis, voice analysis using LPC     method will be evaluated. The superiority of LPC method will be compared with a spectral     analysis using Jitter and Simmer as a positive control.      This clinical study will be performed prospective, positive-controlled, single-blind (i.e.     assessor-blind),and single cohort clinical trial for efficacy   "
99692|NCT01981226|"     Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar     fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography     of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness     increased after ESWT as clinical symptom improves.   "
99693|NCT01981213|"     A: Early predictors of hepatic injury after suicide attempt with acetaminophen:      To explore the following in a pediatric population with acetaminophen overdose due to suicide     attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship     between the total number of vomiting episodes and hepatic injury, 2) the relevance of the     early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and 3) the     presence/absence of illness prior to the suicide attempt and hepatic injury.      B: Characteristics, social behaviour, trends and risk factors:      1. To explore the relationship between children admitted to a paediatric department as a     result of suicide attempts with acetaminophen and their parents and friends. 2. To determine     the extent to which the children had attempted to speak to their parents or other adults     about their problems before their suicide attempts. 3. To determine the prevalence of     self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these     suicide attempts.      C: Establishment of the expression of cytochrome P450 in a pediatric including the     age-adjusted activities.      Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have     already established in our lab.      There will be categorized three groups for comparison:        1. An age-appropriate background population (approximately 200 patients)        2. Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic          injury (approximately 50 patients)        3. Other pediatric patients admitted to their local hospital because of acetaminophen          poisoning (approximately 200 patients) A control urine sample will be analyzed three          months after the suicide attempt.   "
99694|NCT01981200|"     To examine the feasibility of progressive unilateral knee-extension strength training using     ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD   "
99695|NCT01981187|"     The purpose of this signal seeking study is to determine whether treatment with LGX818     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic     malignancies to warrant further study   "
99696|NCT01981174|"     The purpose of this study is to compare the levels of pain resulting from injections of     Botox® for wrinkles on the forehead and between the eyes using two different sized needles     (32 gauge and 30 gauge needles).   "
99697|NCT01981161|"     Under the escalation treatment strategy when a patient displays breakthrough disease     parameters under first line therapy, MS physicians are allowed by the EMEA to switch for     Natalizumab (NTZ) or fingolimod (FGL). NTZ and FGL efficacy have been demonstrated by     randomized therapeutic trial. As both treatments have been tested versus placebo a common way     to compare them is to look at their respective annualized relapse risk ratio decrease.     Roughly NTZ decrease by 70% and FGL by 50%. Nevertheless it is a terrible comparison since     the placebo group had different behaviour in the 2 trials and the patients demographic     features at baseline are also different. Therefore, it is right now totally impossible to     compare these 2 drugs with a decent methodology. Only a head-to-head comparison could do it.     Unfortunately this head-to-head comparison is not available and will not probably be done     under the drug companies initiative. During the time of this study, we will perform a phase     IV, observational, prospective head-to-head comparison of NTZ versus FGL efficacy in 600     patients. Our primary end point will be disease free patients after 1 year of treatment.     Further, this trial will allow us to collect new biological samples, useful for a validation     our project main aim. Further these new samples will be obtained from 3 European countries,     which is a must if we want to generalize our conclusion obtained from a French cohort.     Cooperation at the European level is thus essential for the implementation of this project .   "
99698|NCT01981148|"     Fluorescent lifetime microscopy has emerged as a useful tool to study fluorescent lifetimes     in vitro. Fluorescence lifetime represents the average amount of time a fluorophore remains     in the excited state following excitation and depends on the fluorophores molecular     environment. Fluorescence lifetime ophthalmoscopy (FLIO) is a technique which can quantify     fluorescence lifetimes in the human retina in vivo. The purpose of this study is to     investigate fluorescence lifetime characteristics in the human retina by using a FLIO. The     investigators hypothesize that FLIO will allow to identify areas of retinal metabolic stress     such as ischemia by detecting changes in fluorescence lifetimes.   "
99699|NCT01981135|"     Purpose: The purpose of this protocol is to understand how individuals respond to the air     pollutant ozone at elevated temperatures. Ultimately, this will help us understand what the     risks from poor air quality are during a heat wave.      Participants: We will recruit up to 30 healthy adults, 18-55 years old, to participate in     this study.      Procedures (methods): Subjects will be exposed to clean air and to 0.3 ppm of ozone for 2     hours with intermittent exercise in a controlled environment chamber. For each exposure the     temperature in the chamber will be between 31-34oC (88-93 oF). Because the aim of the study     is to mimic high exposure during a heat wave, we will perform exposures only on days when     mean ambient temperatures was less than 24 oC in Chapel Hill on the previous day.      Primary endpoints will include spirometry and Heart Rate Variability monitoring. Secondary     endpoints will include analysis of blood clotting/coagulation factors, and analysis of     soluble factors present in plasma.   "
99700|NCT01981122|"     This is a randomized, open-label study designed to assess the effects of sipuleucel-T when     administered concurrently or sequentially with enzalutamide.   "
99701|NCT01981109|"     The primary purpose of this research is to describe patient characteristics predictive of an     imaging study positive for distant metastases in patients with castration-resistant prostate     cancer and no known distant metastases.   "
99703|NCT01981083|"     Malnutrition is seen frequently in hemodialysis units in most developing countries.     Malnutrition increases morbidity and mortality in this population and its treatment improves     patient survival and health status The purpose of this study is to compare two strategies to     improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml)     versus egg albumin-based protein supplement (30 g) on a daily basis.      This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment     (SGA) in addition to most used biochemical markers to determine nutritional status.   "
99704|NCT01981070|"     The purpose of this study is to evaluate the impact of two community based interventions for     parents of adults with intellectual or developmental disabilities (IDD) who are requesting     services.      The two interventions will include:        1. Support and Information Intervention - provides parents with support and information          about services for their sons and daughters        2. Mindfulness Intervention - empowers parents through teaching them mindfulness skills      We hypothesize that:        1. Parents in both types of interventions will report benefits (reductions in psychological          distress) maintained at follow-up.        2. Parents in mindfulness intervention group will report improvements in mindful parenting,          self compassion, positive gain, empowerment, and reduced burden. Parents in support and          information intervention group will report improvements in empowerment, positive gain,          and reduced burden.        3. Parents in mindfulness intervention group will show greater improvements by 3 months          follow-up than parents in the support and information group.   "
99705|NCT01981057|"     The aim of this prospective noninterventional study is to evaluate the clinical application     of Numeta® in preterm infants and critically ill neonates in comparison to individualized     prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software     solutions) exact valid prescriptions for ordering parenteral nutrition solutions for     premature infants are compared. Each PN solution is prescribed individually as well as with     Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and     amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for     calculating Numeta prescriptions was protein. The results of PN prescriptions were compared     with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental     content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition     solutions   "
99706|NCT01981044|"     Prospective, multi center, single arm, clinical study to obtain clinical experience with the     use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.   "
99707|NCT01981031|"     BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin     Lispro.      The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects     with type 1 diabetes under a dose of 0.8 U/kg.      This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period     cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes     mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of     BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate     dosing visits.   "
99708|NCT01981018|"     Bipolar Disorder (BD) (previously known as manic depression) is a severe mental health     illness affecting at least 1% of the population and with annual NHS cost estimated at £342     million. It is characterised by alternating episodes of acute mood swings: depression and     mania (mood elation). BD also comes with less severe mood swings we call mood     instability, and ongoing high levels of anxiety that impair well-being even during periods     between the acute mood breakdowns. Anxiety and mood instability are associated with worse     outcome of the disorder.      All these symptoms can be accompanied by the presence of troublesome mental images (e.g.     seeing a memory in the mind's eye) such as intrusive flashbacks of negative past events.     Recent studies suggest that individuals with BD experience more vivid, compelling and     upsetting mental images compared to other patient groups and this could contribute to their     clinical difficulties.      Cognitive Behavioural Therapy (CBT) is a well established and successful psychological     therapy used in the National Health Service (NHS), UK but as yet with limited efficacy in BD.     Targeting mental imagery has long been part of general CBT. In particular, imagery-based     treatment techniques have proved successful in anxiety disorders, but have not been brought     to CBT for Bipolar Disorder yet.      Our study Mood Action Psychology Programme (MAPP) investigates the delivery of a brief     imagery-focused cognitive therapy (imCT) intervention to people with BD, studying a series of     patients in detail one by one a case series). We offer a structured and individualised     psychological treatment in line with the aims of NHS guidelines. The imCT protocol has been     successfully delivered and audited in our psychological service in Oxford (OxMAPP). The     proposed MAPP study aims to formally assess for the first time the effectiveness of imCT. In     particular we hypothesise that imCT via the Mood Action Psychology Programme (MAPP) will     result in (i) reduced levels of anxiety and (ii) reduced levels of low mood after treatment     compared to baseline (both measured over 4 weeks) in individuals with BD.      Overall, this works aims to contribute to improved psychological treatment for BD.   "
129393|NCT01591473|"     The purpose of this study is to evaluate FluMist with and without Ampligen in healthy     volunteers.   "
99710|NCT01980992|"     This study is being done to learn about the medical effects, the safety, and the immunologic     effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out     whether subjects can develop the ability to eat wheat (the food allergen) regularly without     allergic symptoms after stopping the study treatment.   "
99711|NCT01980979|"     The purpose of this study is to evaluate the efficacy of Remodulin in the treatment of adult     patients with congenital heart disease and pulmonary hypertension. Baseline and     post-treatment cardiopulmonary exercise tests will be performed.   "
99712|NCT01980966|"     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety     of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be     intranasally oculated with the challenge virus and will be randomly assigned to receive a     intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be     randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally     twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7     to Day 11.   "
99713|NCT01980953|"     This 4-part study will assess the effect of formulation, food, and active pharmaceutical     ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an     open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period     crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet     formulation, in the fasted or fed state.   "
99735|NCT01980667|"     Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin     in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in     combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of     this combination, to obtain preliminary information on the clinical antitumor activity and to     conduct an exploratory pharmacogenomic (PGx) analysis.   "
99714|NCT01980940|"     Study Part 1 is designed to assess the plasma pharmacokinetics of etoricoxib (ETOR) 4%     dimethyl sulfoxide (DMSO) and propylene glycol (PG) formulations, each at 2 different doses,     upon single-dose topical administration on the knee of osteoarthritis participants. Study     Part 2 is designed to evaluate the efficacy of topical etoricoxib vs. placebo in the     treatment of osteoarthritis of the knee. The primary hypothesis is that topical etoricoxib     will be more effective than placebo in the treatment of osteoarthritis of the knee over 2     weeks of treatment as assessed by time-weighted average change from baseline on the Western     Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analogue (VA) 3.0 pain     subscale.   "
99715|NCT01980927|"     A small number of chiropractors, who align only the atlas C-1, or top vertebra in the     spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction     procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct     misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the     treatment of headache, it has not been formally studied using clinical trials. There is some     data indicating that NUCCA correction can increase intracranial compliance. This intracranial     compliance can be measured by a magnetic resonance imaging (MRI) study before and then after     a NUCCA procedure. In this study, the investigators hope to show that the correction of an     atlas misalignment will increase intracranial compliance in subjects with migraine.   "
99716|NCT01980914|"     The risk of hypoglycemia (low blood sugar) associated with the treatment of diabetes     increases with age. Hypoglycemia is a common reason for admission to hospital for older     patients with diabetes. Older patients are often unaware that their blood sugar is low and     asymptomatic hypoglycemia, as assessed by continuous blood sugar monitoring, is frequent in     the elderly. There is also evidence that older people with diabetes are more likely to     develop cardiovascular events such a heart attack and more likely to die suddenly when     compared to older people without diabetes. It is possible that low blood sugar levels     contribute to the increased frequency of these events, but this possibility has never been     studied. The purpose of this study is to assess how frequently low blood sugar occurs in     older patients with diabetes and to see if low blood sugars adversely affect heart function     in these patients.   "
99717|NCT01980901|"     The Post-Approval Study (PAS) will evaluate the real world data on the Ovation™/Ovation     Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE     cohort to monitor the long-term safety and effectiveness of the device.   "
99718|NCT01980888|"     This study will evaluate the effect of the addition of idelalisib to bendamustine and     rituximab on minimal residual disease (MRD) and evaluate the progression-free survival (PFS)     in participants with previously untreated chronic lymphocytic leukemia (CLL).   "
99719|NCT01980875|"     The primary objective of this study is to evaluate the effects of idelalisib with     obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free     survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).      An increased rate of deaths and serious adverse events (SAEs) among participants with     front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in     combination with standard therapies was observed by the independent data monitoring committee     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data     and terminated those studies in agreement with the DMC recommendation and in consultation     with the US Food and Drug Administration (FDA). All front-line studies of idelalisib,     including this study, were also terminated.   "
99720|NCT01980862|"     Single-site blood collection investigation.   "
99721|NCT01980849|"     To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin     during hospitalization to long-term usage in patients with advanced lung cancer treated by     chemotherapy and/or radiotherapy.   "
99722|NCT01980836|"     Patients with rheumatoid arthritis (RA) are prone to respiratory infections and therefore     recommmended to receive vaccination against seasonal influenza. We and others have shown a     relatively preserved humoral response to vaccination in RA patients. However, the cellular     response as well as the effect of biologics such as tocilizumab on the cellular response has     not been weel studied. The purpose of this study is the evaluate the effect of tocilizumab on     the cellular immune response to influenza vaccine in patients with RA in comparison with     healthy controls   "
99723|NCT01980823|"     The purpose of this study is to determine the effects of combining metformin and atorvastatin     treatment in patients with newly diagnosed breast cancer during the interval between breast     biopsy and surgery.      This study is designed to assess whether tumor proliferation, as measured by the natural log     expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2     weeks of treatment with the combination of metformin plus atorvastatin in patients with newly     diagnosed breast cancer.   "
116077|NCT01766505|"     The purpose of this study is to compare efficacy and safety of candesartan and losartan in     hypertension with heart failure.   "
99725|NCT01980797|"     Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation,     occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign     abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection     in 20-30% of those with BAV. BAV is strongly associated with early development of aortic     valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the     >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of     the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve     disease and we still do not understand the genetic cause(s) of BAV despite evidence for its     high heritability.      The Specific Aims of this study are:        1. To identify the genetic causes of bicuspid aortic valve disease and its associated          thoracic aortic disease.        2. To identify potential pathways to predict the clinical course of BAV disease and for          treating human BAV disease.      To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium     (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to     fulfill the performance of these aims.   "
99736|NCT01980654|"     This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib     combined with rituximab in previously untreated subjects with FL.   "
99726|NCT01980784|"     Severe trauma induces massive metabolic changes that are characterized by hypermetabolism     with increased energy expenditure and catabolism. Early enteral and, if necessary, parenteral     feeding is a major focus of modern intensive care medicine.      After acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of     muscle mass in the area below the level of injury. This dramatic muscle atrophy again leads     to a decrease in energy expenditure. Whereas other survivors of severe trauma typically     regain muscle mass during rehabilitation, spinal cord injury patients typically continue to     lose muscle mass over time, which also leads to changes in body composition. The time course     of these changes is not known. Continuing nutrition without adaption to the reduced energy     expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury     patients to the known unfavorable metabolic consequences. Knowledge of the time course of     these changes would help to provide adequate caloric intake to the patients and improve our     ability for nutrition counseling.      The investigators plan a prospective clinical trial in 25 acute spinal cord injury patients     to determine the changes in energy expenditure and body composition. Major inclusion criteria     are acute traumatic spinal cord injury, age 18-70, neurological level above L1, AIS (American     Spinal Injury Association Impairment Scale) A, B or C.      Measurements of energy expenditure, body composition and nutritional markers in venous blood     are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of rehabilitation     (at the latest after 26 weeks).   "
99727|NCT01980771|"     This program utilizes a community-engaged research approach to implementing and evaluating a     program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The     investigators aims are to assess the impact of this linguistically and culturally tailored     HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and     older, to assess the intervention's impact on the more proximal social and psychosocial     variables that the program is designed to change, and to identify key contextual level     factors that may impact the intervention's impact across segments of this priority     population.   "
99728|NCT01980758|"     The proposed study aims to investigate the effects of laparoscopic gastric plication (LGP) on     excess body weight, body mass index, and weight-related medical and psychological     co-morbidities in obese adolescents. Additionally, we will evaluate the safety and efficacy     of this procedure (implemented within a multidisciplinary comprehensive lifestyle     modification program) on changes in the patients' medical status, psychosocial and     psychological functioning, physical fitness, and health-related quality of life.      Study hypothesis:        1. Laparoscopic gastric plication performed on carefully selected obese adolescents within          a multidisciplinary treatment program providing pre and post-surgical behavioral and          psychological support and education will result in: a) initial and sustained reductions          in excess body weight and body mass index, b) improvements in psychological functioning,          physical fitness, and health-related quality of life, and c) reduction in weight-related          comorbidities.        2. LGP will be a safe procedure, with complication rates that are comparable to or lower          than what has been found in other published reports of surgical weight loss procedures          used in obese adolescents.   "
99729|NCT01980745|"     Autoimmune hepatitis is an autoimmune chronic liver disease whose treatment includes the use     of immunosuppressive drugs, particularly azathioprine, and corticosteroids. When properly     treated, patients have a good survival. One of the major problems related to its treatment is     the the high rate of relapses after stopping therapy that has lead to biochemical and     histological remissions, close to 80%. Many authors recommend continuous treatment throughout     life, resulting in the occurrence of many side effects. Chloroquine is a drug with     anti-inflammatory properties already used in the treatment of other extrahepatic autoimmune     liver diseases. There are some reports in the literature about its beneficial use in liver     diseases such as chronic hepatitis B, and a pilot study in patients with autoimmune     hepatitis, in which its use was associated with a 6.49 times lower risk of disease recurrence     when compared with patients in whom treatment was discontinued after remission. Our purpose     is to investigate, in a double-blind randomized trial with placebo, whether chloroquine     prevents the recurrence of AIH in patients with histological remission after discontinuation     of conventional treatment and to evaluate the occurrence of side effects.   "
99730|NCT01980732|"     The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and     monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors,     medullary thyroid cancer and other cancers expressing somatostatin receptors.   "
99731|NCT01980719|"     The purpose of this study is to determine if inflammatory markers in blood as well as brain     neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or     chronic fatigue.   "
99732|NCT01980706|"     The proposed study will carefully test the hypothesis that a robust dose of baclofen (90     mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the     proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day,     predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety     effects of baclofen within an alcohol dependent population and ascertain whether baseline     levels of anxiety predict response to baclofen.   "
108658|NCT01863771|"     The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese     participants with moderately to severely active ulcerative colitis.   "
99733|NCT01980693|"     Skeletal maturity assessment, defined also as bone age (BA), has an important role in     pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty related     endocrine disorders. Repeated BA assessment is important during the follow up of children     with short stature, with precocious puberty and those treated by growth promoting     medications.      The most commonly used method used for determining skeletal maturity, and thus BA is based on     comparison of a hand and wrist radiographs to a standard series of representative films in     the Radiographic atlas of skeletal development of the hand and wrist by Greulich and Pyle     (GP), which has been issued several decades ago. The suggested method in this study is based     on ultrasound technology, and therefore it is quick, objective, and radiation-free. It     delivers an immediate non biased result without the need to rely on an observer's evaluation     of the hand radiograph and without the need for a specialized radiology facility.   "
99737|NCT01980641|"     Background. Cognitive, communication and physical weakness combined with environmental     changes frequently cause changes in roles, routines and daily occupations. The educational     intervention combines the best choice for teaching new behaviours since it involves the     active participation of the patient in learning.      Methods. Design. Randomized clinical trial. Participants. Total sample: 80 adults who have     suffered a stroke with moderate severity and who have been discharged to their homes.Outcome     variables. BI, FIM, MMSE, CNS, SIS-16, TCT, MRS, MSPSS, QLSF, FRT, RT, TUG, TST, a portable     dynamometer and a sociodemographic questionnaire. Data analysis. Descriptive analyses will     include mean and 95% CI of the values for each variable. The Kolmogov-Smirnov (KS) test and a     2x2 mixed model ANOVA will be used. Intergroup effect sizes will be calculated (Cohen's d).   "
99738|NCT01980628|"     Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of     ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).   "
99739|NCT01980615|"     This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period,     Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of     Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of     Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of     Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to     determine a dose of budesonide that when formulated with glycopyrronium and formoterol     fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to     budesonide following administration of Symbicort MDI.   "
99740|NCT01980602|"     Title: How does exercise improve the calf muscle in patients with poor blood supply to their     leg?      Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to     their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as     easily as a healthy leg would. This causes pain when walking (intermittent claudication),     which often occurs after a reproducible distance e.g. every 50 yards. These patients have a     reduction in their quality of life as they feel embarrassed in social situations e.g. walking     around town requires multiple breaks, so they tend to avoid this and isolate themselves more.      One treatment for claudication is exercising until the pain comes on; which most are     reluctant to do. Walking up to three times a week for an hour, can double most people's     walking distances, but doesn't always. The reason why some improve with exercise and others     do not remains unknown.      This project will be the first randomised controlled trial of exercise in claudicants that     focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare     muscle cells from a group that have exercised and group that have not. We will focus on the     change in muscle cell size and function at present, and later progress to why and how this     happens.      Methods: We will take measurements at the start of the study (baseline), after 6 weeks and     then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking     distances and blood samples. At the time of surgery, muscle from the calf will be taken from     the affected leg. This will be processed at the University's biomedical science department to     look at the different types of muscle fibre and how efficiently they are working.   "
99741|NCT01980589|"     The primary objective was to determine the maximum tolerated dose of carfilzomib given twice     weekly in combination with cyclophosphamide and dexamethasone for patients with newly     diagnosed multiple myeloma.   "
99742|NCT01980576|"     The purpose of the study is:        -  to measure sensitization of the nociceptive system at patients with low back pain in          order to carry out a necessary surgical procedure        -  to examine a possible association between low back pain and degenerative changes        -  to analyse if low back pain is related to the clinical result 6 months after surgery        -  to set up a model for pre-operative measurement of pain.   "
99753|NCT01980433|"     Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and     eye. The neurologic complications include dystonic syndrome, which is a prolonged and     excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily     life activities such as writing, which is particularly disabling, since writing is the only     mean of communication in these patients with significant slurred speech. Treatment is limited     and only partially effective.      Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown     inhibiting properties when applied over the cortex. Since dystonia has been correlated to     hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one     single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right     dystonic hand, assessed immediately at the end of the session.   "
99743|NCT01980563|"     Monitoring ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmatic sperm     injection (ICSI) can be simplified by reducing the procedure to measuring follicles by     ultrasound. Proponents of a simplified procedure claim that the procedure can be reduced to     simple monitoring by ultrasound while maintaining results (numbers of mature oocytes,     percentage of pregnancy and live birth rates). On the other hand simultaneous blood sampling     for measuring hormone levels is still the state of the art in many clinics. A large review     (Cochrane review) stated that although there was no clear evidence for a better outcome,     combined cycle monitoring was still recommended until it could be proven that ovarian     hyperstimulation can be avoided without hormonal monitoring. Investigators therefore perform     a study that compares the results between 2 groups: those with ultrasound monitoring and     those with combined monitoring. Deciding when to plan the retrieval of the oocytes can depend     on subtle differences in the number of large follicles measured by ultrasound, but also on     hormonal levels in the blood of the patient. Therefore the investigators planned a randomized     study in the group of patients with combined monitoring. The investigators examined if     delaying the moment for planning the moment of oocyte retrieval by 24 hours had any effect on     the number of mature oocytes and pregnancy rates and what the effect of rising progesterone     levels might be. The investigators hypothesis was that combined monitoring could lead to     better results since recent studies have thought that rising progesterone levels, if found,     have a negative impact on pregnancy rates. On the other hand the investigators expect to find     that waiting for larger follicles in cases with normal progesterone levels lead to a better     oocyte yield.   "
99779|NCT01980095|"     The test and treat strategy for treating dyspeptic patients who are H. pylori positive is     rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a     new triple therapy to treat H. pylori infection in dyspeptic patients.   "
99746|NCT01980524|"     There is evidence that inhibition of FFA-release by acipimox is associated with a significant     decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of     systolic left ventricular function) in healthy subjects, indicating, that the heart is     dependent on a constant supply of free fatty acids in order to guarantee normal cardiac     function, and it further indicates, that the heart is not able to cover its energy demand by     switching to glucose oxidation.      Since that phenomenon, better known as metabolic inflexibility has been mainly described in     patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and     cardiac function in patients with overt type 2 diabetes.   "
99747|NCT01980511|"     The NeuroVISION Study will characterize the incidence, impact, and risk factors of covert     stroke in adults undergoing noncardiac surgery. We will determine the incidence of acute     covert stroke using an MRI study of the brain in the days following noncardiac surgery. We     will characterize the epidemiology and the impact of covert stroke in patients undergoing     noncardiac surgery, and its association with cerebral deoxygenation.   "
99748|NCT01980498|"     The primary objective of the present phase IIIb study is to assess the efficacy of FPNS     compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable     BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.   "
99749|NCT01980485|"     Narrative: Tobacco smoking remains the single biggest cause of premature death in the United     States and the leading cause of cancer and death from cancer. There is therefore an urgent     need to find effective but practical ways of helping smokers to quit and stay quit. This     randomized trial aims to evaluate two promising methods of helping smokers to quit and to     stay quit.      Design: This is a randomized controlled smoking cessation trial with two stages.      In Stage 1, 225 smokers will be recruited and at assessment they will be randomly allocated     to receiving feedback on their Lung Age as estimated by their Forced Expiratory volume of     air from lungs in one second (FEV1), and exhaled carbon-monoxide (CO) (Intervention group 1)     or to have these measured but not fed back in a manner designed to enhance motivation to quit     (Control group 1). All participants will be provided with group counseling (6 weekly     sessions, with the target Quit Date on the day of the second group meeting), and transdermal     nicotine patches.      Main outcome measure: Stage 1, Past week tobacco abstinence biochemically validated by     exhaled CO < 10 ppm at visit 7 (4 weeks after Target Quit Date).      In Stage 2 (starting visit 7), all participants attending visit 7 (28 days after their Target     Quit Date), will be randomly allocated to receiving either the Forever Free relapse     prevention materials (Intervention 2) http://www.smokefree.gov/pdf.html or the Surgeon     General's Guide How Tobacco Smoke Causes Disease (Control 2)     http://www.cdc.gov/tobacco/data_statistics/sgr/2010/consumer_booklet/index.htm.      All randomized participants will receive a follow-up phone call a week later to remind them     to read and use the materials they have been given, and will attend a follow up visit (8), 6     months after their initial Target Quit Date.      Main outcome measure: Stage 2. Among those who have not smoked in the previous week at visit     7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by     exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during     the prior 5 months (definition of a relapse in this study).      Hypothesis: Smokers who are provided with lung age feedback at assessment will have higher     quit rates 28 days after the target quit date.   "
99750|NCT01980472|"     A phase II Study of an adapted chemotherapy regimen plus bevacizumab in elderly non-small     cell lung cancer patients selected by geriatric assessment   "
99751|NCT01980459|"     In most diabetic patients where low blood magnesium levels occur the important depletion of     cellular levels is usually not measured. This study will measure both blood and oral mucosal     cell magnesium levels before and after 3 months of supplementation with magnesium tablets     (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be     correlated with blood levels of indicators of inflammation (eg C reactive protein) to see     whether the cellular levels are more reliable than blood levels of magnesium for appropriate     treatment of magnesium deficiency in diabetic patients.   "
99752|NCT01980446|"     Determination of vital and functional outcome in comatose survivors after cardiac arrest is     principally based on the identification of predictors of non-awakening, using by clinical,     biological and electrophysiological tools. In patients without presence of non-awakening     predictors, it would be of interest to identify predictive criteria of awakening. The     presence of mismatch negativity during the cortical auditory-evoked potential could     contribute to further progress in neurological prognostication of these patients. However, at     this time, its prognostic value has been insufficiently studied and the optimal time of     realization remains unknown.   "
99755|NCT01980407|"     In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on     gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to     achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the     feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced     gastric cancer.   "
99756|NCT01980394|"     Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the     esophagus and the cardia. The aim of the the study was to establish a method of mechanical     lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer     cells before doing the esophageal anastomosis.   "
99757|NCT01980381|"     Depression and anxiety are among our most common diseases and the prevalence is increasing.     When suffering from depression or anxiety, the individual's ability to cope with everyday     life occupations is decreased, as well as the ability to relate to others. The Tree Theme     Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop     strategies for occupations in everyday life and relationships with others. The method     involves using creative activities to create a life story focusing on everyday occupations     and to create an imagination of future possibilities/goals. The TTM is a short-term therapy     with five sessions. The treatment also implies that the patient is asked to identify various     homework tasks to perform between the sessions.      The aim of the project is to investigate the effects of the TTM compared to a control group     for people with depression and anxiety diagnosis. The intention is to examine the effect on     outcome measures regarding psychological symptoms, everyday occupations and health. The study     has been approved by the Regional Ethical Review Board.      The project is a randomized multicenter study with an intervention group and a control group.     A total of 130 patients will be included. Inclusion criteria are patients with depression     and/or anxiety in the age of 18-65 years and who have problems with their everyday     occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis     and/or who have difficulties to understand and fill out self-rating questionnaires.      The project implies that doctors will refer appropriate patients to the occupational     therapist. After informed consent each patient will be drawn to the TTM or control. Before     and after the treatment, as well as 3 and 12 months after finished treatment the patient will     meet a project assistant in order to respond to questionnaires regarding psychological     symptoms, everyday occupations and health.      The study is a collaborative project involving the Region Skåne, Kronoberg County Council,     and Jönköping County Council. Doctors will recruit patients and occupational therapists will     perform the treatment. The research team comprise of researchers from Kronoberg County     Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health     Sciences in Jönköping (P Wagman).   "
99758|NCT01980368|"     This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors     with peripheral sensory neuropathy. Tai Chi Easy is a simple and repetitive form of exercise     that consists of movements with meditation and may improve peripheral neuropathy symptoms     among cancer survivors.   "
99780|NCT01980082|"     We hypothesized that revision clean head & neck surgery may have a higher rate of wound     infection that may be lowered with prophylactic antibiotic treatment.   "
99759|NCT01980355|"     Major surgery can result in blood loss that can require a blood transfusion during and/or     after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a     treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied     in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We     believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in     reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs     related to your surgical hospital stay.      In this study, you will receive either the drug tranexamic acid or a placebo. The placebo     looks like the tranexamic acid, but does not have any active ingredient in it. The treatment     you get will be chosen by chance, like flipping a coin. You will have equal chance of being     given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the     placebo are considered research.   "
99760|NCT01980342|"     This study evaluates whether there is an interaction between etonogestrel, the progestin     hormone released by the contraceptive implant Nexplanon, and efavirenz, a common medication     used to treat HIV. The endpoints measured in this study will help determine if such an     interaction leads to decreased contraceptive efficacy of the contraceptive implant.   "
99761|NCT01980329|"     The purpose of this study is to evaluate the influence of genetic polymorphism of cytochrome     P450 3A5 on pharmacokinetics of maraviroc and its oxidative metabolites   "
99762|NCT01980316|"     Argatroban is a selective thrombin inhibitor, and previous study had suggested that     argatroban use post percutaneous coronary intervention could potentially prevent reocclusion.     But there has no study on large sample of argatroban treated restenosis vertebral artery     stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion     and Restenosis in patients with Extracranial vertebral Artery Stenting.   "
99763|NCT01980303|"     The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the     body does to the medication) of esketamine when given by the intranasal route (through the     nose) to healthy adult Japanese and Caucasian participants.   "
99764|NCT01980290|"     The purpose of this study is to collect information on the efficacy, safety and tolerability     of telaprevir (in combination with other medications), in patients who have a history of     intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg.,     methadone, buprenorphine) and/or followed in addiction centres.   "
99765|NCT01980277|"     The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in     combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic     breast cancer (MBC) is based on :        -  the medical need in this population with either hormonal-resistant or unsensitive and/or          rapidly progressive disease        -  the preclinical evidences for involvement of PI3K/AKT pathway in tumor progression and          drug resistance, including taxanes as well as its potential reversion by AKT inhibition        -  the high level of frequency of PI3K/AKT activation in HER2-negative MBC        -  the in vitro and in vivo preclinical activity of LY2780301, and its synergistic          combination with various anticancer agents, including taxanes        -  the favourable profile of tolerance of LY2780301 in phase I trial      Weekly paclitaxel is conventionally administered at 80 mg/m²/week and is a standard treatment     in breast cancer (BC) As described above, LY2780301 500 mg once daily has been established as     the RP2D in phase I single agent trial.      Evidence of pharmacodynamic activity was noted at 400-500 mg QD. Conservatively, the first     dose level to be explored will be LY2780301 400 mg QD and paclitaxel 70 mg/m²/week.   "
99776|NCT01980134|"     To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive     colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even     left in-situ) without adverse clinical impact.   "
99790|NCT01979952|"     This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind     clinical trial followed by conversion of each arm to active nintedanib for an additional 6     months comparing the effect of nintedanib 150mg BID on the progression of IPF measured by     using HRCT, lung function, 6MWT, biomarkers, and PROs with continued treatment and     assessments for up to 18 months.   "
99766|NCT01980264|"     In our research, the investigators use the non-invasive 1230 nm ultra-fast laser as the light     source, and utilize the non-linear light microscopic system to observe your skin. This     microscopic system is successfully developed by the Graduate Institute of Photonics and     Optoelectronics, National Taiwan University, and has not been commercialized yet. In the     past, observations by this technology were performed on the skin of five subjects. The early     stage of the skin clinical trial was approved by Research Ethics Committee of National Taiwan     University Hospital. After the trial, the tested sites of subjects were evaluated by a     dermatologist immediately, several hours, 24 hours, 3 days, and 1 week. There were no     inflammatory symptoms, no skin color change, no pigmentation, no wound, no blister formation,     and no ulceration reported. According to the subjects' experiences, they felt no discomfort     during the experiment. After the experiment, there were no inflammatory symptoms and signs in     the observed skin areas. Therefore, the preliminary trial showed that this technology is safe     for the subjects.   "
99767|NCT01980251|"     Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up to     80 % of patients. It is associated with significantly increased morbidity and mortality     during admission and post-discharge. The mechanism behind the condition is poorly understood     but assumably multifactorial, and the purpose of this study is to investigate the     pathophysiology further.   "
99768|NCT01980238|"     Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality     associated with anastomotic leakage (AL) in patients with high risk factors on AL who are     undergoing anterior resections. Although debate about the use of defunctioning stoma     continues, meta-analyses and randomized multicenter trial results support the use of     defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted to     evaluate the efficacy and safety of a new diversion method called spontaneously closed     cannula ileostomy (SCCI), which was designed to protect rectal anastomosis in patients with     high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI)     method.   "
99781|NCT01980069|"     Investigators hypothesized that the surgical condition will be improved with the use of     sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the     effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.   "
99769|NCT01980225|"     In our centre, the implantation rate of frozen blastocysts (cryopreserved using     vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when     compared to data from other observational studies. Retrospective studies have shown that     artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the     blastocyst just before vitrification can have a positive effect on the survival after     warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has     shown a similar survival rate but an increase in the implantation rate of collapsed     blastocysts compared to non-collapsed blastocysts.      The aim of the study is to investigate the effect of artificial shrinkage by laser-induced     collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage     embryos in a prospective randomised controlled trial.   "
99770|NCT01980212|"     In pre-clinical study we found that the thioredoxin reductase activity of serum harbours huge     difference between cancer patients and non-cancer patients, the enzyme activity elevated     remarkably among cancer patients, and after any kind of treatment serum thioredoxin reductase     activity declined remarkably, so we hypothesis that serum thioredoxin reductase activity     could be a warning marker for early progression of first-line treatment for advanced     non-small cell lung cancer   "
99771|NCT01980199|"     This study is designed to determine the efficacy of Fexinidazole as an oral treatment in     Visceral Leishmanisasis sudanese adults patients.      The results of this proof of concept study will allow to make a decision on whether to     proceed with clinical development of Fexinidazole for visceral leishmaniasis.   "
99772|NCT01980186|"     This study will use linear 2D ultrasound imaging to look at the brain of individuals     diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It is     hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain and     will further allow the imagining of brain areas important to language and social function.   "
99773|NCT01980173|"     This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone     therapy. Included patients are randomized to two arms: the Sulprostone + Bakri balloon arm     versus the Sulprostone alone arm.      The main objective of this study is to compare the efficiency of a care strategy including     the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence     study juxtaposing costs and the necessity of invasive procedures (arterial embolization,     ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum     hemorrhage.   "
99774|NCT01980160|"     The primary study hypotheses are that, without increasing doses of breakthrough medications     or device intolerance, the Nometex™ device worn for 5-days beginning with the day of     chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer     will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce     the severity of nausea.      The secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes,     day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without     increasing doses of breakthrough medications or device intolerance.   "
99775|NCT01980147|"     Severe mental illness such as schizophrenia and mood disorders typically develops at a young     age and can cause life-long disability. Currently available treatments cannot cure severe     mental illness. This makes it important to find ways to prevent severe mental illness in     young people before it has a chance to develop. This research study will pilot a new     preventive intervention for young people who are at high risk of developing severe mental     illness. The investigators will target early preceding factors (the 'antecedents') to severe     mental illness which includes anxiety, unusual hearing and visual experiences, the loss of     previously acquired abilities, and sudden and unpredictable changes in mood. These     antecedents strongly predict an increased risk of developing severe mental illness. They are     often impairing and distressing to the individual but can be improved with self-management     skills and parent training, and they are present in the individual years before the onset of     severe mental illness which makes them an ideal target for early intervention. The goal is to     intervene early enough in the young person's life that severe mental illness can be     prevented, hopefully leading to a happy, healthy and productive adulthood. The investigators     want to test the acceptability and short-term efficacy of this new preventive intervention.   "
99791|NCT01979939|"     To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and     treatment experienced non-cirrhotic subjects   "
99777|NCT01980121|"     Food residue in the stomach of patients scheduled to have surgery is considered a major risk     factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise     after aspiration is associated with significant morbidity and mortality. The risk of     pulmonary aspiration is especially important in pregnant women, as they may often require     surgery without having observed appropriate fasting. In pregnant patients scheduled for     elective surgery, standard preoperative guidelines apply as the general non-pregnant surgical     population (8-hour fasting of solid food and 2-hour fasting of clear fluids). A bedside     ultrasound assessment of the status of the gastric content and volume would be of great value     for the clinician. This technique has recently been shown very promising in fasted     non-pregnant patients scheduled for elective surgery. Therefore, it is important to study its     feasibility in the pregnant population scheduled for elective Cesarean Delivery.      The investigators hypothesize that no residual solid contents will be found in the gastric     sonography, and a small volume of gastric fluid will be observed in the antrum in both supine     and right lateral decubitus.   "
99778|NCT01980108|"     Solid food or fluid residue in the stomach is always a major concern when patients need     medical procedures under sedation or general anesthesia, due to the high risk of pulmonary     aspiration of the stomach contents. This is especially important in emergency procedures,     when a fasting period is not observed. The aspiration of the stomach contents into one's     lungs can lead to serious complications (such as severe respiratory failure). Information     from a bedside ultrasound assessment of the stomach may be a very useful tool to decide     whether or not it's safe to proceed, cancel or delay a surgical procedure.      The investigotrs hypothesize that a mathematical model can be constructed to predict clear     fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in     healthy adult volunteers.   "
99814|NCT01979640|"     The purpose of this study is to find the adequate additional bronchial cuff volume after     achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood     through cuff) in double lumen tube   "
99782|NCT01980056|"     Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin     in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (< 20%     blasts in bone marrow, peripheral blood, or both) by World Health Organization (WHO)     classification with an intermediate 2 (INT-2) or high-risk score (ie, ≥ 1.5) as assessed by     the International Scoring System (IPSS) after failure of hypomethylating agent-based therapy.     Based on 3 completed studies and xenograft models, Vosaroxin is hypothesized to be safe and     will effective in this patient population.   "
99783|NCT01980043|"     The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal     prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum     with sutures to the abdominal wall under needlescopic control. Further, investigators will     evaluate the short and long-term clinical outcomes after this novel approach to treating     rectal prolapse.   "
99784|NCT01980030|"     This is a Phase I/II multicenter study which aims to assess the toxicity profile of     Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT.      A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT will     be included.      The main endpoint is the incidence and severity of adverse events.   "
99785|NCT01980017|"     The incidence of type 2 diabetes mellitus (T2DM) is increasing rapidly. The combination of     T2DM and smoking is particularly lethal, as smokers with T2DM are significantly more likely     to develop a number of health related complications. Community-based diabetes education     programs (DEPs) have been developed to support patient self-care behaviours (e.g. adherence     to oral medications, insulin therapy, nutrition management, regular blood glucose monitoring,     and physical activity); however, specific assistance for smoking cessation is rarely     provided. Our investigative team has developed a knowledge transfer and practice change     process to introduce evidence-based interventions for smoking cessation into clinical     practice settings. This process is known as the Ottawa Model for Smoking Cessation (OMSC).     Investigators believe there is an opportunity to use the OMSC intervention to dramatically     enhance the effectiveness of DEPs in addressing smoking cessation among smokers with T2DM,     and in so doing, improve quit rates in this high risk population.      The purpose of this project is to evaluate the effectiveness of the Ottawa Model for Smoking     Cessation (OMSC) intervention in multiple diabetes education programs (DEPs) in Ontario. A     two-level recruitment strategy will be employed. Eighteen DEPs will be recruited, and then a     consecutive sample of eligible smoker-patients will be recruited from each DEP over a 6-month     recruitment period. Investigators want to test the impact of the OMSC intervention on quit     rates among smokers with diabetes and pre-diabetes referred to these programs. Investigators     will conduct a matched-pair cluster design trial at 18 DEPs in Ontario. These sites will be     matched based on number of annual referrals for diabetes education (≤ 500/year or >     500/year). Within each pair, sites will be allocated randomly to either OMSC intervention or     control group. Following randomization, the OMSC program will be implemented at the     intervention sites over a 6-month period. Following the implementation period, a consecutive     sample of smokers will be recruited from both OMSC intervention and control DEPs over a     6-month recruitment period. It is estimated that this will yield a sample of approximately     445 smokers in each of the OMSC intervention and control groups. The primary outcome will be     the biochemically-validated 7-day point prevalence abstinence rate six months after an index     visit to the DEP. Secondary outcomes will include: rates of identification and intervention     of smokers, and diabetes educators' attitudes, confidence, and perceptions of barriers and     facilitators to implementing smoking cessation support as part of routine care.      If proven effective, the OMSC is appropriate for implementation in DEPs across Canada and     could have profound impacts on patient and community health.   "
99786|NCT01980004|"     The purpose of this study is to compare the role of potassium citrate supplementation with     dietary education versus dietary education alone in the reduction of stone risks and events     in patients with predominantly calcium phosphate kidney stones.   "
99787|NCT01979991|"     To develop a computer program that will improve CT image quality and decrease the amount of     x-ray radiation that future patients may be exposed to when they have a CT examination.   "
99788|NCT01979978|"     School-based interventions are generally ineffective for preventing weight gain in children.     In 2007, a group from the University of British Columbia, developed a program called Healthy     Buddies, that relied on peer mentors to help young children adopt healthy living behaviours.     Pilot studies revealed that the program effectively prevented weight gain in children. This     trial had never been tested on a large scale using a more scientifically sound study design.     We developed a large school-based randomized trial to overcome that limitation and test the     hypothesis that that a school-based peer-led healthy living program would reduce adiposity     and increase physical activity among children 6-12yrs old.   "
99792|NCT01979926|"     The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the     Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With     acute and acute exacerbation of chronic bronchitis for 7 days.   "
99793|NCT01979913|"     Increased intraocular pressure (IOP) has been identified as the most important risk factor     for the development and the progression of glaucoma. Data from large interventional studies     have shown that a decrease of IOP is associated with a reduced risk of progression of the     disease. This underlines the importance of a potent and save IOP lowering therapy. The     introduction of preservative free tafluprost offers a new treatment possibility using a     potent topical prostaglandin analogue without the disadvantages of a co-administered     preservative. The current study seeks to investigate the effect of an 8 week therapy with     preservative free tafluprost on intraocular pressure in patients with ocular hypertension or     primary open angle glaucoma having an IOP of 30 mmHg or more.   "
99794|NCT01979900|"     Mycobacterium Vaccae for Injection (Trade Name Vaccae) is a kind of bio-products developed     by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got The New Drug Certificate in     1999. Vaccae has been approved for adjuvant therapy of tuberculosis(TB), and is also the only     recommended drug in TB immunotherapy by WHO. It was approved for production and sale by Anhui     Zhifei Longcom Biopharmaceutical Co.,Ltd. in 2001, and got favourable comment in therapy of     tuberculosis.      The purpose of this study is to add new indications for Vaccae, mainly to prevent     Tuberculosis for high risk groups of Tuberculosis Infection . In December 2012, China Food     and Drug Administration approved of the plan Phase III Clinical Study of Efficacy and Safety     of Mycobacterium Vaccae to Prevent Tuberculosis in high risk groups of Tuberculosis     Infection. In the test, 10,000 cases whose skin tests of PPD are strongly positive are     enrolled. Using random, double-blind, and placebo-controlled methods, the study is carried     out to evaluate the efficacy and safety of Vaccae in preventing Tuberculosis. Meanwhile, in     this test, TB incidence and degree of pathological changes of experimental group are lower     than that of control group, and no drug-related SAEs are reported in treatment groups.   "
99795|NCT01979887|"     This is an exploratory study to evaluate endpoints used to characterize participants with and     without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and     symptoms of MGD. No investigational drug will be administered in this study.   "
99796|NCT01979874|"     Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral     supplementation will improve systemic inflammation, vascular function, and symptomatic status     of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA     affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of     inflammation.   "
99797|NCT01979861|"     The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation     is safe and effective for reducing menstrual blood loss in women with excessive uterine     bleeding (menorrhagia)   "
99798|NCT01979848|"     Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the     successful removal of the cancerous prostate via surgery. Hypothermic cooling via the     investigational Endorectal Cooling Balloon has been shown by our group to significantly     reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic     prostatectomy, and improve the patient's long term quality of life (QOL). However before     successful translation of the endorectal balloon can proceed into the world wide usage, we     must understand:        1. How effectively the tissues for continence and sexual function are cooled within the          pelvis.        2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool          sink' or diminish the effective cooling and        3. Determine if the endorectal balloon can be re‐designed for improved QOL outcomes in men.      This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling     for prostate cancer surgery. MRI is non‐invasive. A simple confirmation of effective     hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as     it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with     temperature adaptive software can accurately map these gradients with non‐invasive technique,     and answer formidable questions of the effectiveness of hypothermic cooling of the prostate     and its direct translation into improved continence and sexual function after surgery. The     purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI     with subjects who will receive the investigational endorectal cooling balloon to help further     understand how the cooling balloon works, which may translate to other uses in the future,     including the diagnosis of patients at a high risk of developing prostate cancer.   "
99799|NCT01979835|"     The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The     GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the     GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by     reducing failed insertions and perforations. We now need to know how easy it is for doctors     to see and measure the distance of the anchor to the outside of the uterus. The purpose of     this open, prospective, observational study is to assess the feasibility of measuring the     distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz     and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of     insertion, the acceptability of the device to Canadian women and any complications. We will     also compare expulsion rates in post-abortion and other women.   "
99800|NCT01979822|"     The clinical study aims to investigate the numbers of predefined complications in the first     six month after implantation of the implantable LENUS Pro® medications pump for intravenous     application of treprostinil sodium in patients with PAH.      The manufacturer is Tricumed GmbH, Germany; exclusive marketing rights: OMT GmbH & Co KG     78665 Frittlingen, Germany.   "
99801|NCT01979809|"     The purpose of this study is to conduct a two site, three arm randomized intervention study     to improve fruit and vegetable intake, improve whole grain intake and reduce sweetened     beverages in young adults aged 21 to 30 years. This work is potentially very high impact in     light of growing overweight and obesity and decreased health status overall, and potential     dietary benefits to children of our target age group.   "
99802|NCT01979796|"     It is well established in studies across several countries that tobacco smoking is more     prevalent among schizophrenic patients than the general population. Electronic cigarettes     (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are no     large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial is     needed to compare efficacy and safety of these products in this special population.   "
99810|NCT01979692|"     The hypothesis of this proposal is that needle confocal laser microscopy (nCLM) may improve     the yield of trans thoracic needle biopsy (TTNB) of lung or mediastinal lesions by     differentiating between viable and necrotic tissue. This may reduce the number of biopsy     attempts and eventually the complication rate of the procedure.   "
121445|NCT01696279|"     To provide information about the safety and efficacy of lanthanum carbonate in children     compared to standard treatment.   "
99803|NCT01979783|"     Transversus abdominis (TrA) and lumbar multifidus (LM) muscle have been proposed to play key     role in stability of the lumbosacral spine. The muscles' functional and/or structural     deficits have been linked to the low back pain (LBP) syndrome. Evaluation of the transversus     abdominis and lumbar multifidus muscles' function in clinical practice is scarce and not well     defined due to number of reasons. Surface electromyography of TrA and LM muscles, as a method     of examining muscles function, is not involved in clinical routine. Rehabilitative Ultrasound     Imaging (RUSI) of the TrA and LM, apart from providing information about their morphology,     could be helpful in assessing their function. Since concentric muscle contraction results in     the shortening and thickening of the muscle, evaluation of the potential association between     muscle's morphometry, assessed by the ultrasound, and electromyography, may be of potential     clinical interest. However, this potential relationship is context-dependant. Our aim was to     establish the difference in the thickness change of the TrA and LM muscle during activation     in subjects with and without low back pain, and to establish the possible correlation between     electromyography and the thickness change of these muscles assessed by ultrasound in both     groups of subjects.   "
99804|NCT01979770|"     This study aims to investigate the relationship of the various exposures during infancy and     childhood on later health and development of adolescents. Various exposures to be assessed     include, but not limit to, nutritional status, body composition, energy expenditure, dietary     intake, micronutrient status, breastfeeding, lifestyle, and other environment exposures.      The study will specifically aim to respond these research questions:      1.1 What are the factors associated with overweight, obesity, and stunted in adolescents? 1.2     What are the factors associated with increased risk of NCDs during adolescence? 1.3 What are     the factors associated with cognitive functioning during adolescence? Since numerous     variables were collected, additional research questions can be possibly studied or other     interested variables can be included in the future.   "
100013|NCT01977040|"     This is a multicenter retrospective observational study of women diagnosed with a vasa previa     during pregnancy or at delivery who delivered between 2000 and 2012. The study hopes to be     able to describe techniques utilized to screen for and diagnose vasa previa as well as to     describe the maternal characteristics and identify potential underlying risk factors that may     provide a basis for future screening recommendations for vasa previa and treatment protocols.   "
99805|NCT01979757|"     Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity.     Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized     technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics,     USA) is a new method that involves washing and filtering the fat to prepare the graft. The     investigators compared the subjective and objective outcomes of two fat-processing methods,     centrifugation and PureGraft filtration.      Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT     in our department between April 2011 and September 2012. The patients were preoperatively     divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15     received fatgrafts processed by washing in PureGraft bags. The patients were followed up for     12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q     questionnaire to all the patients both preoperatively and one year postoperatively. The     BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.   "
99806|NCT01979744|"     Although first generation DES reduced instent restenosis, still remained the unsolved     problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had     been developed to improve the biocompatibility of stent coating focused on polymer compared     to first generation DES, so that second generation stents showed better outcomes compared     with first generation DES. On the other hands, in third generation DES, further refinement of     DES involved more flexible stent platform. Promus ElementTM (Everolimus eluting stent, Boston     Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting stent, Medtronic     Vascular, Santa Rosa, CA) are the third generation drug eluting stents which are designed to     increase flexibility. In previous randomized controlled studies, both of these stents have     shown at least non-inferior angiographic and clinical outcomes compared to second generation     DES. However, there is lack of data about comparison of angiographic and clinical outcomes     between Promus ElementTM and Resolute Integrity®.      IVUS is one of the widely used intracoronary imaging devices to provide more reproducible and     accurate information about coronary anatomy than angiography in current practice.8 Optimal     stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an important     factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been many studies     to evaluate the procedural or clinical benefit of IVUS guided angioplasty. However, The     clinical benefit of IVUS-guided angioplasty with stent implantation is still in a     controversy. In the previous studies, IVUS-guided stent implantation showed positive or     negative beneficial effect on clinical outcomes according to their study subjects. However,     the stents used in the previous studies are less useful in current practice of cardiology and     there is lack of data of 3rd generation DES, which have different stent profiles and outcomes     with their predecessors.      Thus we would perform a prospective randomized study in order to compare the efficacy of     IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary     lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long     coronary lesions would have better clinical outcomes compared with conventional     angiography-guided strategy. We also intend to assess the clinical outcomes after Promus     ElementTM and Resolute Integrity® implantation.   "
99807|NCT01979731|"     The objective this study is evaluated if job rotation (change works that function every to     work hours)contributes to reduce absence from work to complaints musculoskeletal disorders.     And:        -  Improve general health status        -  Improve musculoskelettal symptoms        -  Improve work performance        -  Decrease costs with absence   "
99808|NCT01979718|"     It was well known that the mirror therapy could decrease pain of upper-limb amputated     patients.      The mirror therapy is known to make a plastic change some parts of the brain perceiving the     painful body part and modulating its signal by feedback of visual information mirrored with     the corresponding contra-lateral normal parts.      In this study, post-operative analgesic efficiency of the virtual reality using a mirror     therapy after total knee arthroplasty will be evaluated.      This clinical trial will be performed in the form of prospective, single-blind (i.e.     assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.   "
99809|NCT01979705|"     Infectious disease is the single biggest cause of death worldwide. New infectious agents,such     as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually     emerge and require new investigations to understand pathogen biology and pathogenesis in the     host. Witness the Influenza A pandemic. Concerns about new viruses and their impact on health     and the economy are also increasing. Current alerts sent out by the Ministry of Health (about     the novel coronavirus and the Avian influenza A virus) are but cases in point. These likely     reflect advances in science, which have allowed novel pathogens to be identified.      Because of its geography, Singapore is vulnerable to new pathogens through importation or the     global travel of its citizens. Hence we must be ever ready to meet unexpected challenges     anytime.      On the administrative front, Singapore General Hospital has a Disease Outbreak Task-force     which has in place many plans that can be activated should there be a large-scale epidemic.      What is missing thus far is a program that will enable us to perform scientific studies in     the setting of an epidemic. Hence in this study, we will, in collaboration with the Program     in Emerging Infectious Diseases (EID) in Duke-National University of Singapore Postgraduate     Medical School, attempt to (i) detect novel, previously undescribed pathogens; (ii)     characterize viruses (not necessarily novel but emerging and re-emerging) that are raising     concern or causing clusters or epidemics in the hospital and/or country; (iii) characterize     immune responses to such viruses in healthcare workers as well as patients (those affected by     these viruses and those exposed to the affected). The techniques that will be used will be     those not routinely available in a hospital's service labs.      Some patients will remain undiagnosable with the best available technology. Since new     laboratory tools that can detect previously undiagnosed pathogens may become available in the     future, the study also aims to archive specimens from patients whose illnesses remain     undiagnosed.   "
99811|NCT01979679|"     The purpose of this research study is to measure how many of the dopamine receptors     lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective     disorder and over what time period the occupancy occurs. This is research because lurasidone     is an investigational medication that has not yet been approved by the Food and Drug     Administration (FDA). Dopamine receptors have key roles in many processes, including the     control of motivation, learning, and fine motor movement. The degree of occupancy and the     transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent     relapses is a controversial area that this study will address.      In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand     18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use     of these receptors. Researchers hope that quantifying the amount of receptors being occupied     by the medication will help them to determine the best dose of study medication in terms of     improvement and least side effects related to body size and gender as well as in preventing     relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also     be performed. MRI is a scanning method which makes pictures of parts of the brain using a     large magnetic field. This study will use a particular kind of MRI called fMRI, or functional     MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task.     fMRI will allow the researchers to investigate patients regional brain activation during     cognitive (mental) and emotional tasks.   "
99812|NCT01979666|"     The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates     induce peripheral vasodilation and may improve blood supply to the affected tissue.      This study aims to test whether the use of a nicotine patch may accelerate the healing     process from AVN of the knee.   "
99813|NCT01979653|"     The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone     for hemodynamic stability and quality of sedation in elderly patients under spinal     anesthesia.   "
99815|NCT01979627|"     The transradial approach for coronary angiography and angioplasty is now widely used in     catheterization laboratories worldwide, which had been shown as advantages over the     conventional femoral and brachial approaches due to the lower incidence of bleeding and other     cardiovascular complications. However, the transradial approach does not seem suitable for     5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery which is     one of the two terminal branches of the brachial artery is usually larger than radial artery     and it may be as a potential approach for cardiac catheterization. Recently, some reports     have demonstrated that the transulnar approach may be both feasible and safe for coronary     angiography and angioplasty in selective patients.we performed this study to evaluate the     safety and feasibility of transulnar approach coronary catheterization in real world     non-selective patients.   "
99816|NCT01979614|"     This is a mechanistic study in patients with coronary artery disease on the effects of     Serelaxin on micro- and macrovascular function.   "
99817|NCT01979601|"     This study is designed to measure the effects of LGT209 when given intravenously to patients     with high cholesterol who are on stable doses of statin medications, and to healthy subjects     with elevated cholesterol   "
99818|NCT01979588|"     Previous work has shown that the epidemiological context of a patient's presentation can     provide important information for clinicians to aid in diagnosis and treatment. With current     electronic health records, it is increasingly possible to perform syndromic surveillance that     is local and specific to a patient's characteristics.      The investigators have developed algorithms for syndromic surveillance for a number of     conditions in which contextual information might be of use to treating clinicians. The     syndromic surveillance algorithms already developed are for influenza-like-illness, whooping     cough, asthma exacerbation, Group A Streptococcal pharyngitis, and gastroenteritis infection.      The investigators plan on studying these tools with a clustered randomized control cohort     study evaluating how clinical decision making is affected by use of these tools by outpatient     general practitioners. The goal is to incorporate these validated algorithms into a quality     improvement tool which will provide point-of-care clinical decision support to clinicians   "
99819|NCT01979575|"     1) Observe the hemodynamic and cardiovascular changes associated with the change from the     supine to the steep Trendelenburg position, 2) Observe the hemodynamic and cardiovascular     changes during intra-abdominal insufflation used during laparoscopic surgical procedures.   "
99820|NCT01979562|"     The purpose of this study is to examine the skeleton of the legs and the running style in     order to predict a possible overuse injury.   "
99821|NCT01979549|"     The primary objective is to investigate the adverse events during upper gastrointestinal     endoscopy with and without sedation in Chinese population   "
99823|NCT01979523|"     This randomized phase II trial studies how well trametinib with or without Akt inhibitor     GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to     other parts of the body (metastatic). Trametinib and GSK2141795 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     trametinib is more effective with or without GSK2141795 in treating patients with metastatic     uveal melanoma.   "
99824|NCT01979510|"     The primary objective of this study is to evaluate the safety and tolerability of MK-0663B     (etoricoxib/tizanidine) among participants with moderate-to-severe acute low back pain.   "
99825|NCT01979497|"     To determine whether the addition of adhesive stripping to a wound closed with dermal sutures     improves outcome of wound closure. We hypothesize that the combination of adhesive strips to     a wound closed with dermal sutures does not add significant cosmetic improvement of the     resultant scar.   "
99826|NCT01979484|"     This study will compare the blood levels of PPI-668 resulting from two different formulations     - the current capsule and a new tablet.   "
99827|NCT01979471|"     Cardiovascular disease (disease of the heart and blood vessels) is one of the leading causes     of death in Canada. It also carries a financial burden on the Canadian economy with a yearly     cost close to $21 billion divided between loss of productivity and healthcare costs. The     majority of cardiovascular disease cases (90%) are caused by factors that can be controlled     and modified. These factors include high blood pressure, high cholesterol, diabetes (high     blood sugar), tobacco smoking, unhealthy diet, obesity, physical inactivity and high alcohol     consumption. Such factors are very common and not very well controlled and so individuals who     have any of these factors would be at risk of having cardiovascular disease. As such     controlling these factors will reduce the risk of having cardiovascular disease and improve     the individuals' quality of life. Pharmacists frequently work with patients and their family     doctor to provide cardiovascular care. Having a pharmacist involved in cardiovascular care     may help patients with cardiovascular disease or at risk of having the disease because they     are more accessible and may have more opportunities to educate people about cardiovascular     medications. This might lead to better prevention and control of cardiovascular disease.      Purpose:      The research study will assess if a community pharmacy cardiovascular risk reduction     intervention can help reduce cardiovascular risk.      Procedure:      If the individual has an elevated blood pressure, cholesterol, blood sugar, waist     circumference or body weight or is physically inactive, have an unhealthy diet, a smoker or     taking medications for any of the previously mentioned conditions, the pharmacist will assess     the cardiovascular disease risk [risk of having a cardiovascular event (e.g. heart attack or     a stroke)] using a computer program. If the individual is at high risk s/he will be asked to     take part in the study.      If the individual agrees to take part in the study s/he will be randomly assigned to either     the Usual Care Group or the Advanced Care Group. All participants have an equal chance of     being assigned to either group. If assigned to the Usual Care Group, the individual will     receive the care and services that would normally be provided by the pharmacist. At 3 months,     the pharmacist will see the individual who will be offered the Advanced Care at that time.      If assigned to the to Advanced Care Group, the individual will be asked to meet with the     pharmacist every 3-4 weeks over a 3 month period. During these meetings, the pharmacist will     conduct an assessment that may include blood pressure, waist circumference, height and weight     measurements and talk to the individual about their cardiovascular risk and medications. The     individual and the pharmacist will come up with a plan for how to try to lower his/her     cardiovascular risk. The pharmacist will discuss this plan with their family doctor. The     individual will be asked to conduct some laboratory tests before the 3 months visit; these     tests may include HbA1c (a blood test to measure blood sugar control over the last 3 months)     and cholesterol to assess the effect of the intervention on cardiovascular risk.   "
99828|NCT01979458|"     The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic     imaging technique. Specifically, topographical surface contrast reconstructed from the PSE     data will be compared to conventional imaging contrast to assess if PSE provides enhanced     contrast of abnormal tissue.   "
99829|NCT01979445|"     There are two separate objectives in this study:        1. to demonstrate the pharmacodynamic profile when patients treated with cangrelor are          switched to oral prasugrel administered 30 min after cangrelor infusion is discontinued          and        2. to demonstrate the pharmacodynamic profile when patients treated with cangrelor are          switched to clopidogrel 600mg administered during or immediately after the infusion.   "
99830|NCT01979432|"     The main objective of this study is to look for the interest forecast of the IPS as     infra-clinical cardiovascular marker in the prediction of a change of the cognitive functions     (MCI) at the elderly of 70 and more years old without clinical cardiovascular pathology.   "
99831|NCT01979419|"     PRIMARY OBJECTIVES      -Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia     (SIVD)      STUDY DESIGN      -This is a non-randomized, natural history, observational, registry study.      SAMPLE SIZE AND RECRUITMENT      - Five hundred subjects will be enrolled at each clinical site (50 NC, 200 with MCI, 50 with     AD, 100 with vMCI, and 100 with SIVD)      SUMMARY OF KEY ELIGIBILITY CRITERIA        -  Newly enrolled subjects will be between 50-80 (inclusive) years of age.        -  1) Cognitively Normal Subjects        -  2) MCI subjects        -  3) AD subjects        -  4) vMCI or SIVD      PROCEDURES        -  Recruited subjects will have clinical/cognitive assessments, biomarker and genetic          sample collection, and imaging.        -  Subjects will be followed up for 36 months from the baseline visit. All assessments are          to be performed every year from baseline(0, 12, 24, 36 months), except; 1) FDG-PET and          amyloid-PET will be performed every two years, i.e., on baseline and at 24 month visit.          2) CSF collection will also be performed on baseline and at 24 months visit. 3)          Clinical/cognitive assessment and MRI evaluation will additionally be done at 6 months          from baseline to determine short term change.      OUTCOME MEASURES        -  Group differences for each clinical, cognitive, biochemical, and imaging measurement.        -  Rate of conversion or change of disease severity will be evaluated among all groups        -  Correlations among biomarkers and biomarker changes   "
99832|NCT01979406|"     The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the     positive (vaccine) control as studied in normal healthy volunteers.   "
99833|NCT01979393|"     This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs     that have effects on tumour growth, blood supply, invasion and spread.      Therefore, we want to find out whether taking cabozantinib after treatment with surgery and     chemotherapy is effective and safe for patients who responded or had stable disease after     their chemotherapy.      All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization     or response to the standard chemotherapy will be split into 2 groups (cabozantinib or     placebo).   "
99834|NCT01979380|"     To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male     subjects      To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male     subjects      To Evaluate the effect of food on bioavailability after KD101 single oral dosing in healthy     male subjects   "
99835|NCT01979367|"     Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity     pathologies derived from neurological ischemia disorders using the combination of     Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation     (TENS) therapies.   "
99836|NCT01979354|"     Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating.     Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control     group in term of analgesia.   "
99890|NCT01978652|"     The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017     (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese     and Caucasian adult healthy participants. The secondary Objective is to assess the safety and     tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian     adult healthy participants.   "
100368|NCT01972399|"     The primary objective of this study is to compare the clinical outcomes of using Er: YAG     laser along with bone graft and barrier membrane to conventional mechanical debridement also     with bone graft and barrier membrane in the treatment of peri-implantitis infections.   "
99837|NCT01979341|"     The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH     agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger     has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole     use results in reduced embryo implantation due to luteal phase insufficiency. The combination     of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to     overcome the luteal phase insufficiency effecting endometrial receptivity.      In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg     Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in     normoresponders will increase oocyte maturity, embryo quality and embryo implantation and     reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose)     alone trigger.   "
99838|NCT01979328|"     The primary objective of this study is to examine the flow characteristics of deep venous     flow in the leg veins using Doppler ultrasound imaging and how this flow is modified by the     application of a plaster and with a geko™ device in healthy volunteers   "
99839|NCT01979315|"     Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully     understood.Increased pain sensitivity in the primary area of pain (local pain) is considered     a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low     back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is     considered to present a more central phenomenon. It is suggested that pat ents with enhanced     pain sensitivity report high level of disability. Despite fact that pain and disability are     associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability     is unknown. It has also been suggested that muscle function changes may be driven by pain.     The possible role and contribution of trunk muscles function to pain and disability phenomena     remain unknown.      This study was aimed to estimate prevalence and possible correlation among pain     hypersensitivity and functional and electromyography parameters of trunk muscles in patients     reporting early phase of chronic LBP.   "
99840|NCT01979302|"     Depression in older home healthcare patients occurs very often, is typically not treated     appropriately, and leads to poor health outcomes. This study tests an intervention, called     Depression Care for Patients at Home or the Depression CAREPATH, designed to help home     healthcare nurses work with the patients, their family, and their doctors in managing     depression treat depression according to clinical guidelines and to manage its treatment over     time. Patient outcomes, measured at 3, 6, and 12 months, include guideline-consistent changes     in depression treatment and reduction in depressive symptoms.   "
100014|NCT01977027|"     Motor learning can be affected by the sensory difficulties that may be experienced as a     result of a stroke. This study will help us better understand what kinds of sensory     information can help with the re-learning of grasping with the affected hand despite the     sensory difficulties produced by the stroke.   "
99841|NCT01979289|"     This research study will examine if a targeted computerized cognitive remediation (CCR)     training program is better for treating geriatric depression than general computer activity.     We will also examine whether this intervention is related to improvement in cognitive and     depressive symptoms. Elderly patients with depression, who have, and who have not been     treated with antidepressant medication for their illness, will be recruited to participate in     either a 30 hour cognitive remediation program or general computer activity designed to be     both challenging and interesting. They will be asked to complete between 1 and 3 hours of     remediation per day over 4 weeks. While undergoing the cognitive remediation participants     will be asked questions to assess their symptoms of, as well as the severity of, their     depression weekly. This will inform researchers about whether or not the CCR is helping to     improve depressive symptoms. At the end of the CCR study, participants will be given a     battery of cognitive tests design to tell investigators whether or not the CCR improved their     thinking in a variety of different ways including improving attention, memory, and     organization. Investigators will also determine whether changes in participants' thinking are     related to changes in their mood or other depressive symptoms. It is hoped that information     gained from this study will help investigators to better understand the brain processes     associated with depression, recovery from depression, and will help inform the development of     future alternative treatments for this illness.   "
99842|NCT01979276|"     This clinical trial is for subjects with multiple myeloma that has returned after treatment     (relapsed) or did not respond to prior treatment (refractory). The study is in two parts,     Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in     combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the     effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is     that overall response in a cohort of patients treated with romidepsin + pomalidomide +     dexamethasone will be 60 percent.   "
99843|NCT01979263|"     The purpose of this project is to study the feasibility and efficacy of attention bias     modification treatment (ABMT) in a randomized-controlled sample of anxious youth.   "
99844|NCT01979250|"     Background Fuchs' Endothelial Dystrophy Fuchs' Endothelial Dystrophy (Fuchs' ED) is     characterized by changes on the inside of the cornea, which leads to a substantial decline in     visual acuity. The only effective treatment option for Fuchs' ED is corneal transplantation.      Corneal transplantation Corneal transplantation surgery has seen major advances in the last     decade, and the Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) procedure has     now become the preferred method.      Outcome There have been a substantial number of publications on outcome after DSAEK surgery,     and the procedure has several advantages over the former preferred method of transplantation,     penetrating keratoplasty (PK).      Despite the apparent success of the DSAEK procedure, visual acuity is seldom fully restored     even in otherwise healthy eyes. Several studies have tried to clarify this matter but so far     results have been conflicting.      Hypotheses        1. The reduction in visual acuity and contrast sensitivity in patients with Fuchs'          endothelial dystrophy is correlated with corneal thickness, corneal light scatter, and          the type and magnitude of optical disrupting guttae in Descemet's membrane.        2. The subjective visual function after corneal transplantation with a posterior lamellar          graft is correlated with the optical properties of the grafted cornea (thickness, light          scatter, irregularities on the anterior, and posterior corneal surfaces)      Materials and methods      In a controlled prospective trial of DSAEK patients, we aim to register different     morphological patterns, monitor visual performance and optical parameters.      Three sex and age-matched groups will be compared:      Group 1: 40 patients that undergo DSAEK surgery Group 2: 40 patients that undergo combined     cataract and DSAEK surgery. Group 3: Control group of 40 patients with normal corneas that     undergo cataract surgery.   "
99891|NCT01978639|"     This study will assess the outcomes of three currently available regenerative treatments     (FloGraft, autologous stem cell therapy, platelet rich plasma therapy) for painful     degenerative conditions of the joints. Patients receiving one these treatments will be     assessed before the treatment procedure and followed up at four points over the six months     after their procedure. Patients' pain, quality of life, and pain medication use at follow up     will be compared to baseline levels. The investigators hypothesize that all three treatments     will be effective in reducing pain, improving quality of life, and reducing pain medication     usage.   "
99845|NCT01979237|"     Shoulder anterior dislocation is a major disease entity in emergency department. There are     more than 10 reduction methods that have been reported. Traditional reduction methods require     sedatives, which could cause adverse effects on the patients such as respiratory suppression     and allergy. There are some reduction maneuvers reported recently which do not need sedatives     prior to performing reduction, including FARES method and SPASO method. So far, there are no     well-designed study to compare these two methods. Besides, in clinical experience, we found     that combining these two methods could even get higher successful reduction rate. This study     is aimed to compare these two methods as a prospective randomized design, and furthermore, to     show that combining these two methods could get higher successful reduction rate.   "
99846|NCT01979224|"     Introduction. Asthma is a chronic inflammatory disorder of the airways, identified by airflow     obstruction. Unfortunately only 2.4% of American asthmatics meet internationally recommended     criteria for control. The lack of knowledge in parents of asthmatic children has been a     direct result of minimum or no control at all, so the educational programs need to be     assessed in terms of improvement of the control. Target. To determine whether an educational     intervention aimed at parents of asthmatic children 4 to 11 years improved clinical control     measured by Test Childhood Asthma Control. Material and Methods. Randomized controlled     clinical trial in 42 patients randomly divided into two groups that were evaluated in the     same time knowledge and control of asthma, a measurement was performed at baseline and     monthly for nine months. The experimental group attended an educational intervention for     individual reinforcements through this period, the control group was only monitored   "
99847|NCT01979211|"     The standard treatment of surgery followed by radiation therapy can stop tumors from growing     in the head and neck region in most patients. However, the cancer can recur or can spread to     other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by     blocking certain cellular chemical pathways that lead to tumor development. It was approved     by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and     neck cancer.      The purpose of this study is to determine how easily cetuximab can be added to treatment with     radiation therapy in patients with cutaneous cancer of the head and neck. This study will     also look at how well cetuximab added to radiation therapy works over time and how well this     treatment is tolerated.   "
100015|NCT01977014|"     This observational study aims to chart patients which get their prostacyclin treatment via     the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical     follow-up of these patients. And by this also charting complications that might occur in     relation to treatment.      Participating centres are located in Denmark, Norway and Sweden.   "
99848|NCT01979198|"     The surgical results of thoracolumbar and lumbar burst fracture have been reported to be     comparable between patients with and without fusion in a midterm follow-up. There is,     however, no report comparing the results of fusion and non-fusion with a long-term follow-up.     Therefore, a long term comparative study is still needed to focus on the issues of functional     and radiographic outcomes, especially preservation of the motion segment in the long run, to     determine whether fusion should be a routine procedure for surgically treated burst fractures     of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative     study of fusion and non-fusion based on our previous work, with an average 134 months of     follow-up.   "
99849|NCT01979185|"     This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184     on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.   "
99850|NCT01979172|"     The study aims at determining the best biometry calculation formula to be used in IOL     calculation of cataract patients how previously underwent laser refractive correction surgery   "
99851|NCT01979159|"     In order to determine if speech-language therapy has positive effect, reliable measurement     tools are required to document outcomes. Currently, there is very limited information     concerning the measurement of changes in speech production as a result of treatment for     acquired apraxia of speech and aphasia. This study will obtain information concerning the     reliability of several speech production measures over time. Thirty persons with chronic     aphasia and apraxia of speech will be asked to provide speech samples in response to commonly     used assessment tools on three sampling occasions so that the stability of measurements may     be examined.      After establishment of appropriate outcome measures, a small, pilot treatment study will be     conducted with four participants. The participants will receive a new treatment for aphasia     and acquired apraxia of speech and outcomes will be measured relative to speech and language     production.   "
99852|NCT01979146|"     The purpose of this study was to test the efficacy of a computer-based automated symptom     monitoring telephone system used by patients who received chemotherapy for their cancer to     communicate unrelieved symptoms they experienced to their oncology providers.   "
99853|NCT01979133|"     This study is being done to see if icariin will help with depression in patients with bipolar     disorder and alcohol or cocaine use disorders. The pills used in this study contain 20%     icariin.   "
99854|NCT01979120|"     A prospective observational multi-centre study for the validation of the ApneaScan algorithm     (integrated in ICD devices (with or without cardiac resynchronization therapy function) of     the Incepta series for the screening of sleep disordered breathing in patients with stable     symptomatic chronic heart failure, using portable polygraphy monitoring device (Embletta     Gold) as reference for the Apnea-Hypopnea-Index (AHI).      Secondary objectives are the detection of severe sleep disordered breathing in patients with     clinically indicated in-laboratory polysomnography, as well as correlations of the AHI     detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial     fibrillation and ventricular arrhythmia.   "
99855|NCT01979107|"     In this randomized controlled study it is investigated if a proactive action by the general     practitioner offering individuals without formal education a preventive health check will     lead to a larger number of diagnoses in form of chronic obstructive pulmonary disease,     cardiovascular diseases, and diabetes among participants in the intervention group compared     to the control group. Furthermore it will be investigated if the proactive action by the     general practitioner will be associated with a higher smoking cessation rate at 12 month     follow-up.   "
99856|NCT01979094|"     To collect and organize data into a repository for future research.   "
100123|NCT01975610|"     CC-292 is an oral agent that is under clinical development for the treatment of rheumatoid     arthritis an autoimmune inflammatory disorder.      This study will test the clinical effectiveness and safety of an orally (PO) administered     dose of CC-292 compared to placebo in US female patients currently on background Methotrexate     (MTX) with active Rheumatoid Arthritis (RA   "
99857|NCT01979081|"     The Physical Functioning Inventory (PFI) is a standardized patient reported outcome measure     that assesses preclinical disability. Preclinical disability is a functional state in which     people are still able to complete daily living tasks (e.g., walking, bathing) but are     changing the frequency or modifying the way that they complete the tasks. The investigators     have done some preliminary research using the PFI as an online monitoring tool (Richardson     2012), but further study is required to examine its psychometric properties and its     suitability for use as a primary outcome measure. This measurement study has been designed to     identify the optimal number of items on the PFI and to determine the reliability, validity,     and responsiveness of the PFI when administered to a sample of adults and older adults both     with and without chronic conditions. This project will also allow us to evaluate the use of     self-monitoring of physical function and the added value of rehabilitation professionals to     support self-monitoring. Using the results of the PFI, the investigators aim to develop a     tailored population-based rehabilitation self-management intervention delivered through a     secure messaging system in the patient's electronic personal health record (myOSCAR) that     focuses on the early detection and prevention of preclinical disability.   "
99858|NCT01979068|"     -  Vascular Inflammation is a key factor in both the pathogenesis and outcome of          atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying          vascular inflammation within atherosclerotic plaque        -  Recently, unique subsets of obese individuals, such as metabolically obese but normal          weight (MONW) and metabolically healthy obese (MHO), have been getting an attention        -  Therefore, the purpose of this study is to examine the relationship of vascular          inflammation,measured by FDG-PET, with various body sized phenotypes   "
99910|NCT01978392|"     The specific aim of the study is to evaluate the health benefits of a series of group     workshops designed for workers with chronic physical health conditions. The facilitated     workshops apply principles of pain and illness self-management to help workers deal with     health-related challenges while at work. The workshops address issues of pain management,     physical job demands, pacing of work, communication, problem solving, and coping. Half of the     participants in the study will be randomly assigned to attend workshop sessions (10 hours     total), and all study participants will be followed for one year. The primary hypothesis is     that workers who participate in these workshops will show improvements in work engagement and     reductions in work limitation in the subsequent 12 months.   "
99859|NCT01979055|"     Asthma in older adults has been overlooked, understudied, and inadequately treated. While     asthma programs targeting the unique needs of children, teenagers, women, minorities, and     other populations have been successfully developed, there are currently none for older     adults. This is particularly distressing as the asthma hospitalization rates, mortality     rates, quality of life, and control are significantly worse in the elderly as compared to     other age groups. It is clear that novel approaches are needed to improve the care in this     population.      The investigators group has been active in the research of asthma in the elderly. The     investigators have analyzed national asthma data sets to look for disparities in older     adults, have conducted qualitative research to determine factors associated with poor control     in the elderly, and have performed a pilot study of a self-regulation intervention which was     able to improve outcomes. The investigators also have over 20 years of experience in asthma     self-regulation interventions and physician communication enhancement for multiple     populations of asthma patients. The investigators will combine these strengths into their     current protocol.      The intervention program will be based on the self-regulation theory of behavior, which will     enhance the participants' ability to self-manage this chronic condition, actively involve the     participant in their own health care management, and produce sustained results. In this     proposal, the investigators will evaluate a self-regulation asthma intervention in a diverse     population of older adults. The intervention will be personalized to the challenges and goals     each individual faces, which will enhance its applicability in different populations. This     intervention will incorporate standard asthma education, complementary techniques for which     older adults have expressed a strong interest, and enhanced communication with each     participant's physician. Asthma specific outcomes will be assessed at 1, 6, and 12 months.     The primary goal of this intervention is to decrease health care utilization (emergency     department, urgent care, hospital, and unscheduled visits) for older adults with asthma. The     investigators will also assess the ability to improve quality of life, asthma symptoms,     asthma control, lung function parameters, self-efficacy, and cost effectiveness.   "
99860|NCT01979042|"     Renal colic is usually caused from an obstructing stone along the ureter. Some of the     patients present with a high level of creatinin in the blood, even though there is a normal     functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal     function during acute changes.      Several works have shown that modern urinary markers such as NGAL (neutrophil     gelatinase-associated lipocalin), KIM-1 (Kidney Injury Molecule-1) and others rise earlier     and are much more sensitive for kidney insult. There is a lack of research on their role in     acute kidney obstruction   "
99861|NCT01979029|"     To evaluate the influence to the blood supply of the anastomosis and the harvest of the No.     253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and     resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or     dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of     rectal carcinoma.   "
99862|NCT01979016|"     The primary objective of the study is to assess the efficacy of dupilumab, compared to     placebo, in adult patients with moderate-to-severe atopic dermatitis.   "
99863|NCT01979003|"     To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in     revealing the depth of endometrial cancer invasion.   "
99864|NCT01978990|"     Modern medicine provides many solutions that are intended to help control the patient's blood     glucose level: insulin and other medications to lower it, glucose tablets or glucagone to     raise it when it gets dangerously low, glucometers to quickly measure the blood glucose     level, pumps and pens to inject insulin or other injectable medicine, etc.The objective of     this trial is proving the concept and the feasibility of using a medical informatics system     comprised of computer hardware, software and a smartphone application to achieve better     outcomes.   "
99865|NCT01978977|"     Investigators propose to assess,the safety and tolerability profile (number of participants     with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as     first line treatment of patients with metastatic Breast Cancer.   "
99866|NCT01978964|"     This is an open label phase 1b maintenance therapy study to evaluate the long-term safety,     immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients who     have demonstrated safety and clinical benefit on the original ONT-10-001 phase 1 study.   "
99867|NCT01978951|"     If primary health-care officers and Villages Health Volunteers (VHVs) be trained to render     proper CKD care, it is interesting if their intimate relationship and commitment to their     responsible village households will result in better outcomes when compared with the     conventional care model as mention above. In this project, we plan to compare the     effectiveness of a conventional care program against an integrated multidisciplinary CKD care     program provided by nephrologists in conjunction with well-trained paramedical personnel and     VHVs on CKD progression.   "
99868|NCT01978938|"     This is a Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to     Assess the Efficacy and Safety of Eravacycline Compared with Levofloxacin in Complicated     Urinary Tract Infections (cUTI)   "
99869|NCT01978925|"     The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared     to usual care, in patient discharge in an emergency department in patients with hypertension     and/or diabetes mellitus type 2.   "
99870|NCT01978912|"     The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in     subjects with lumbar disc herniation.   "
99871|NCT01978899|"     Studies have shown that patients who weigh more at the time of cancer diagnosis may be at     increased risk of complications from surgery, fatigue, poor body image and other problems.     Some research suggests that losing weight after cancer diagnosis can lead to improvements in     these problems, as well as having other potential benefits for cancer survivors. Programs     that reduce calories and increase exercise have been shown to help cancer survivors lose     weight, but more research is needed to develop and test weight loss programs in cancer     survivors.      This study is designed to look at the ability of a 15-week diet and exercise program to help     cancer survivors lose weight. The investigator will look at changes in weight, body     composition, quality of life, fatigue, body image as well as diet and exercise patterns, to     see if this program can help men and women feel better and live healthier lives after cancer     diagnosis.   "
99872|NCT01978886|"     The purpose of the study is to investigate how high the prevalence of diabetes (known and     unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40     %.      Another purpose is to investigate whether patients with diabetes have a worse and more     painful frozen shoulder than patients without diabetes, and whether the diabetes have an     influence on the prognosis.   "
99933|NCT01978080|"     The specific aim of this study is to evaluate if tremor severity and quality of life can be     improved more using continuous home monitoring along with traditional assessments versus     traditional assessments alone.   "
99934|NCT01978067|"     The aim of this study is to further demonstrate the safety , validity and quality of     (sexual)life of vaginal operation for previous cesarean scar defect resection.   "
99873|NCT01978873|"     This clinical trial is designed on the basis of an unmet clinical need, as well as other     factors including: 1) the ability to identify subjects at high risk of dying early from their     disease, 2) the fact that hormonal therapy has already been shown to improve survival when     applied early in the natural history, 3) the availability of chemotherapy such as cabazitaxel     that can improve survival in subjects with advanced disease and 4) that chemotherapy     (docetaxel) given concomitant with hormone treatment has proven to prolong time to     progression.      It is the investigators hypothesis that a more appropriate group of patients who may benefit     from the curative potential of systemic chemo-hormonal modality is that with minimal, but     detectable disease who have a high probability of developing metastatic disease, clinical     symptoms and eventually death from prostate cancer in a defined time frame. The investigators     hypothesize further that the approach is likely to be more effective at a time of minimal     tumour burden, resulting in minimization of the overall burden of therapy and better quality     of life while on treatment.      This trial will determine whether any benefit is gained by adding chemotherapy before     hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or     high risk disease.   "
99874|NCT01978860|"     This is a prospective, non-randomized, first-in-man investigational study, to assess the     safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™     micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO     penetration rate.      Each study subject/patient will have a total of one (1) procedure performed for this study.   "
99875|NCT01978847|"     Retrospective review will allow for an evaluation of potential patient- or procedure-related     factors that are associated with the development of either radiologic or clinical     adjacent-segment pathology.   "
99876|NCT01978834|"     This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone     Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly     woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total).     Significant and good correlation was observed between Density Index (DI) determined with     Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition,     with determination of 90% sensitivity and specificity thresholds, significant number (65-75%)     of patients could be diagnosed without additional verification with DXA.      First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy     patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60     to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for     diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed.     The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and     non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict     the outcome of currently available fracture risk assessment tools.        1. To investigate optimal configuration of ultrasound parameters and patient          characteristics for prediction of proximal femur and lumbar spine BMD for women in each          four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.        2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status          with a reference female population (American-Caucasian) in each four decades of age; 50          to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.   "
99877|NCT01978821|"     the purpose of this study was to study the effect of stem cell therapy on common symptoms of     cerebral palsy patients.   "
99878|NCT01978808|"     For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle     aspiration (EUS-FNA) are well established techniques in clinical practice. We hypothesize     that a FNA needle with a side port could improve the diagnostic yield. The aim of this     prospective randomized study is to determine whether there is a difference in diagnostic     yield in patients with pancreatic masses for evaluation.   "
99879|NCT01978795|"     This study evaluated Brain 101: The Concussion Play book, an intervention that provides     education and resources on concussion management for high schools. The study hypotheses were     that athletes and parents who viewed the Brain 101 program would demonstrate increased     knowledge and self efficacy in concussion management, and that use of the intervention would     positively affect school concussion management practices.   "
99892|NCT01978626|"     Cognitive Behavioral Therapy for Insomnia (CBT-I) has been proven as an effective     intervention for the non-pharmacological treatment of insomnia. This study hypothesizes app     programs of smart phone would enhance the compliance and performance of behavioral     intervention of CBT-I. During a 3-year study period, 3 app modules, including electronic     sleep diary along with message reminder system, social persuasion system and Tai-Chi practice     system will be tested subsequently for their efficacy.   "
99893|NCT01978613|"     This trial is conducted in Europe. The aim of the trial is to investigate safety,     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple     doses of NNC0113-0987 in an oral formulation in healthy subjects.   "
99894|NCT01978600|"     The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period     using Simbrinza™ topical ophthalmic suspension.   "
99896|NCT01978574|"     Cognitive problems are a primary concern for people with multiple sclerosis. In many cases,     people with MS report these issues to be more debilitating than the motor symptoms that are     targeted by most treatment strategies. For people with MS, impaired memory and thinking     skills can interfere with the ability to function efficiently in multiple professional and     personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking     skills is a vitally important research priority. We now know that engaging in intellectually     enriching activities helps protect against the negative impact of MS disease-related declines     in memory and thinking. Such activities contribute to something called 'cognitive reserve,'     which serves as a protection against disease-related declines in memory and thinking. Thus     far, no one has created a treatment that aims to provide a concentrated 'dose' of     intellectual enrichment to build cognitive reserve. The present intervention aims to do     precisely this. Here, we have developed a program of enriching activities that are delivered     via a personal iPad. This allows for a 12-week 'treatment' that is entirely home-based, while     also providing close personal contact between participants and our study personnel, who will     communicate daily via emails. Week by week, participants choose from a menu of intellectually     enriching activities such that their treatment is dynamic and customizable to fit their     interests. The intervention is designed to be fun, as we hope the activities will be     incorporated into people's lives beyond the period of the study itself. Given what we already     know about the striking benefits of cognitive reserve to protect against disease-related     declines in cognitive functioning, we expect to show that treatment with a daily, intense,     intellectually enriching schedule of activities results in improved thinking and memory for     people with MS. We will also investigate the positive impact of our treatment on the brains     of people with MS through brain scans. We expect to see evidence for a shift toward more     efficient processing in the brain, changes that translate to improved memory and thinking     skills.   "
99880|NCT01978782|"     Depression is the most common mental health disorder among HIV-patients. Recognizing and     treating depression is important in order to improve quality of life and health outcomes in     those living with HIV. In clinical practice selective serotonin reuptake inhibitors (SSRIs)     are used most frequently in HIV patients with depressive symptoms. A complicating factor in     the concomitant use of antiretroviral agents and antidepressant therapy is the occurrence of     drug-drug interactions. Citalopram can be seen as one of the preferred SSRIs in HIV-infected     patients because citalopram has a relatively favourable drug interaction profile compared to     other SSRIs. Raltegravir is an HIV-1 integrase inhibitor and is frequently being used as     antiretroviral agent in combination with tenofovir/emtricitabine in HIV-patients. Raltegravir     has shown sustained antiretroviral activity, is generally well tolerated and has little     propensity to interact with other drugs because it does not inhibit or induce CYP450 enzymes.     Theoretically, no clinically relevant drug interaction is expected between raltegravir and     citalopram as raltegravir is not a CYP2D6 substrate and thus will not be affected by the     possible inhibition of CYP2D6 by citalopram. Raltegravir is metabolized by UGT but citalopram     is not known to influence UGT. A possible interaction may occur through inhibition of P-gp     mediated transport of raltegravir by citalopram. However, even when no drug interaction is     expected theoretically, it may be recommended to collect sufficient clinical evidence to     support this hypothesis because unexpected interactions with raltegravir have been observed     in the past. In order to be able to recommend raltegravir and citalopram concomitant use, a     pharmacokinetic study in healthy volunteers is proposed.   "
99881|NCT01978769|"     In the current study we will examine a specific aspect of these processes that has yet to be     studied. We will test the effect that a physically effortful assignment has on the choices     that a preadolescent makes using a forced choice paradigm in which the participant will be     asked to choose between and carry out either a high cost-high reward option (HR) or a low     cost-low reward (LR) option. The HR option will demand a significant amount of physical     effort and will be paired up with a large reward as opposed to the LR option which will be     less demanding physically and paired up with a small reward. The assignment will be carried     out using a hand held dynamometer which measures the power produced by the participants'     upper extremity.      We propose that a child with attention deficit hyperactivity disorder (ADHD) will choose a     task that involves less effort despite the small reward tied to it compared to a control     child who will choose the more demanding task and the larger reward.   "
99882|NCT01978756|"     In order to evaluate the late outcome in patients curatively treated for breast cancer, a     special outpatient clinic will be developed.      There are two main purposes of the outpatient clinic. The first purpose is evaluating the     results of the radiation treatment by mapping A) late toxicity and B) tumour control and     survival.      The second purpose is that this outpatient clinic for late outcome will also function as a     pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which     multiple late outcome variables will be recorded. In this pilot we want to investigate     whether physical presence of the patient on the outpatient clinic, allowing physical     examination, has any added value to the questionnaires filled in by the patient at home.      The ultimate aim of this new CAT project is to use these multicentric data to develop models     for predicting both oncological outcome and late side effects. Insight in the beneficial and     adverse effects of a certain treatment using these predictive models, will be required choose     the optimal treatment for the individual patient using a shared decision making process.   "
99883|NCT01978743|"     In this study investigators will use a multi-modal imaging approach of MRS and fMRI to     comprehensively assess the biological changes in the brain associated with EFV-based regimen     (EFV/FTC/TDF), specifically alterations in the brain circuitry, function and local     neurochemistry, and their correlation with neuropsychological function.   "
99884|NCT01978730|"     As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial     effects on learning and memory ability in animal models of vascular dementia (VaD). The study     hypothesis is that SaiLuoTong capsule will be effective in the treatment of patients with VaD     and will be well tolerated. The purpose of the study is to determine the efficacy and safety     of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include     general cognitive function, executive function, daily living skills, and mental behavior     changes of symptoms in VaD patients.   "
99885|NCT01978717|"     The purpose of this study is to prove whether general anesthesia combined with epidural     anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general     anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the     prognosis.   "
99886|NCT01978704|"     The aim of this study is to compare the feasibility and the efficacy on short-term glucose     control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the     carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with     insulin pump   "
99887|NCT01978691|"     Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid     metabolism. The purpose of this study is to investigate the effect of a dietary supplement     containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on     change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial.     The supplement is ingested once per day for the duration of six months, and participants will     attend a follow-up visit one month after the end of the intervention. The study will enroll     232 participants (58 per study arm) in four research centers in southern Finland.   "
99888|NCT01978678|"     The application of biomarkers that are more closely associated with eosinophillic airway     inflammation, such as measurements of FeNO level, cell count in induced sputum or bronchial     reactivity could improve asthma control by better directing treatment. A systematic review     and meta-analysis is to be conducted to assess the efficacy of tailoring asthma intervention     on clinical symptoms compared with exhaled nitric oxide or induced sputum count.   "
99889|NCT01978665|"     The objective of this study is to investigate if there is an effect on exercise performance     og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic     obstructive pulmonary disease(COPD)   "
99895|NCT01978587|"     The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics     (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage     renal disease (ESRD) receiving hemodialysis   "
99900|NCT01978522|"     Recruiting, retaining and gathering complete data on participants in research projects, be     they patients or health professionals, can be extremely difficult. These problems increase     the risk that research will be abandoned before its true value is appreciated, or lead to     delays in resolving uncertainty for decision makers, while further studies are done. Poor     recruitment, retention and outcome collection frequently lead to many prospective studies     being extended, increasing costs. Researchers need to use strategies that are themselves     evidence-based. This study proposes to link with an existing longitudinal ageing study called     NICOLA to provide evidence on what research participants prefer in relation to providing     personal information through a self-completed questionnaire. NICOLA is a large study of     people over the age of 50 that is being conducted in Northern Ireland. NICOLA is aiming to     recruit 8500 people and will ask them questions about participation in social activities,     including organised structured and informal activities; relationship quality; loneliness;     stress; resilience; quality of life; alcohol intake; food poverty and assess their health and     wellbeing. Participants in NICOLA agree to having an interviewer visit them at home to ask     questions about their lives, complete questionnaires in their own time and attend a health     assessment appointment. They also agree to being followed up over a course of at least 10     years. The research described here will examine the impact of differing times and formats of     a self assessment questionnaire on completion rates, specifically:        -  To assess the effect of being given a questionnaire during a face to face interview with          a researcher compared to receiving it by post        -  To explore the potential impact of interview fatigue on completion rates   "
99901|NCT01978509|"     The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus     a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing     colonoscopies.   "
99902|NCT01978496|"     To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in     relieving symptoms of acute migraine and to further explore the dose response relationship of     eletriptan.   "
99903|NCT01978483|"     Ultraviolet (UV) light is part of normal sunlight and has many effects on human skin and     health. One of the harmful effects of long-term UV light exposure is that it can cause skin     cancer. The mechanism by which UV light causes skin cancer is not entirely understood. One of     the ways UV light causes cancer is by modifying DNA molecules in the cells of the skin.     Another mechanism involved in cancer formation by UV light is immunosuppression. By this     mechanism, UV light inactivates cells of the immune system of the skin. The immune cells are     responsible for the detection and destruction of foreign substances and organisms such as     bacterias and viruses but they also recognize and destroy cancer cells. UV light is known to     prevent cells of the immune system to destroy cancer cells.      In laboratory experiments, a medication called denosumab has been shown to diminish the     inhibition of ultraviolet-induced suppression of skin immunity. In other words, this     medication could block the effect of UV on cells of the immune system and might allow     patients taking this drug to be better protected from skin cancer.      The objective of this study is to test whether denosumab blocks the immunosuppressive effect     of UVB light in healthy subjects. This study is divided into two stages. In the first stage,     ten subjects (Cohort 1) will be sensitized to diphenylcyclopropenone (DPCP), a topical     sensitizer commonly used for the treatment of alopecia areata and cutaneous warts. By     reexposing the subjects to DPCP in incremental doses, dose-response levels of cutaneous     hypersensitivity reactions in normal skin will be obtained. This will allow comparison of the     normal levels of DPCP-induced cutaneous hypersensitivity (CHS) reaction in non UV-exposed     skin (Cohort 1) to the CHS obtained from the two UVB-exposed experimental groups of Cohort 2.      In the second stage of the study, 20 subjects (Cohort 2) will be exposed to an     immunosuppressive dose of ultraviolet B (UVB) 24 hours prior to DPCP sensitization. This is     expected to result in the abolition of CHS upon rechallenge with DPCP. In order to assess     whether denosumab can reverse UVB-induced immunosuppression, the subjects will have     previously been randomized to receive a single 1mL injection of either 60 mg denosumab (group     A; 10 subjects) or 1 mL saline (group B; 10 subjects) two weeks before UVB exposure. CHS     reactions elicited by DPCP rechallenge will be compared between the denosumab and saline     groups.   "
99904|NCT01978470|"     The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS     system.   "
99905|NCT01978457|"     We will develop a procedure for conditioning cue-cocaine associations in human drug users.     Next, we will reactivate that learning and intervene pharmacologically to prevent the     reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and     pharmacological approach will have significant potential for persistently inhibiting relapse.   "
99906|NCT01978444|"     Radical gastrectomy for gastric cancer with D2 lymph node dissection has been widely applied     in advanced gastric cancer. However,for most patients,tumor local-regional recurrence has     been proven unavoidable.      Recently, many clinical studies have proved that some cancer cells and cancer nodes exist in     the mesogastrium which can be hardly removed by conventional radical gastrectomy with D2     lymphadenectomy. It is suggested that Complete mesogastrium excision (CME) is imperative and     should be added to D2 lymphadenectomy in order to reduce the risk of local recurrence.      Thus, the comparison of short-term and long-term outcome between laparoscopic D2     lymphadenectomy plus complete mesogastrium excision and conventional laparoscopic D2     lymphadenectomy for locally advanced gastric cancer based on a well designed randomized     controlled trial is needed.   "
99908|NCT01978418|"     The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is     cleared at birth. This process is mediated through the activation of airway epithelial sodium     channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation.     In humans, postnatal ENaC expression is dependent on gestational age and its activity,     measured as nasal potential difference, correlates with lung compliance. Therefore, in the     human newborn infant ENaC may be important for physiologic postnatal adaptation. The activity     of ENaC is increased by beta-agonists, such as salbutamol. We hypothesize that low pulmonary     expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid     and thereby contributes to the risk for development of transient tachypnea of the newborn     (TTN) in term infants born by Caesarean section (CS).   "
99909|NCT01978405|"     Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes     after contrast media injection. Although the risk of developing CIAKI is low in patients with     normal renal function, it is dramatically higher in patients with conditions such as diabetes     mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast     agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore,     strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently     needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We     hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and     endothelial dysfunction in type 2 diabetes.   "
99963|NCT01977690|"     The purpose of the study is to see whether a clavicle splint can decrease the pain after     posterior cervicothoracic surgery. The term cervicle splint conveys that the investigators     do not deal with clavicle fractures here but use the splint he stabilize the posterior     cervical area. The investigators want to demonstrate this in a prospective randomized manner.   "
99911|NCT01978379|"     We are conducting a study to evaluate two investigational devices that may help us better     monitor discomfort or pain in anesthetized patients during minimally invasive lung surgery.     We want to collect information on how people respond to pain related to their surgery.     Currently, we use blood pressure (BP) and heart rate (HR) to check the response to pain. In     this study, we will also use two devices called the Medasense PMD-100 and PhysioDoloris     monitors to look at measurements of pain. We will compare the measurements from the study     devices to the measurements of heart rate and blood pressure. We hope to enroll about 40     subjects in this study at the University of Washington Medical Center.   "
99912|NCT01978366|"     This study is designed to provide 6-months continuous dosing with the study medication,     called HT-100, on participants who successfully completed the predecessor study     (HALO-DMD-01). The main purpose of this study is to assess chronic safety, tolerability,     pharmacodynamic activity (testing the drug's effect on DMD) and population pharmacokinetics     (measuring how much drug is in the bloodstream) in participants with a broad spectrum of     Duchenne muscular dystrophy (DMD).   "
99913|NCT01978353|"     Preview research reports evidence of cognitive plasticity among individuals with amnestic     Mild cognitive Impairment, and small-size studies have suggest that this population can     benefit from memory training. This project intends to assess the efficacy of cognitive     training in persons with MCI with a randomized controlled design.      The hypothesis is that cognitive training can improve memory performance for persons with     amnestic mild cognitive impairment and this improvement can be maintained over time.   "
99914|NCT01978340|"     The study objective is to collect heart rate, respiration rate and motion data of patients     admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the     monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data     regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient     turns will also be collected and compared to data collected by EarlySense contactless     monitor. Different patient population will be monitored including obese, morbidly obese,     patients with or without obstructive/central apnea, patients with or without arrhythmia as     well as healthy population who arrive to sleep lab for general evaluation will be monitored   "
99915|NCT01978327|"     GSK2647544 is an orally available, selective inhibitor of Lp PLA2 that is being developed for     the treatment of Alzheimer's disease. The current study is a single-blind, randomised,     placebo-controlled, 4-cohort study to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of repeat doses of GSK2647544. Cohorts 1, 2 and 3 will evaluate escalating     doses of GSK2647544 in young healthy volunteers for 7 days, 7 days, and 14 days,     respectively. Cohort 4 will evaluate repeat doses of GSK2647544 in healthy elderly volunteers     for 14 days. Additionally, Cohorts 1 and 3 will include an assessment of potential drug-drug     interaction with simvastatin to examine CYP3A4 inhibition by GSK2647544.   "
99916|NCT01978314|"     This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult     volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with     acute kidney injury (AKI).   "
99928|NCT01978145|"     This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 weeks     noninferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg     capsule-based inhaler and a multi-dose inhaler administered BID in adults with COPD. The     primary objective of this study is to establish the non-inferiority of the efficacy of the     FSC 250/50 mcg capsule-based inhaler compared to the FSC 250/50 mcg multi-dose inhaler     administered BID. The study consists of 6 phases: Pre-screening, Screening/Run-in (3 weeks),     Treatment Period 1 (12 weeks), Washout (minimum 4 weeks), Treatment Period 2 (12 weeks) and     Follow-up (1 week). The total duration of the study for each subject will be at least 32     weeks.   "
99929|NCT01978132|"     Patients with primary hyperaldosteronism experience more cardiovascular events compared to     patients with primary hypertension, independent of the blood pressure level.      In this research we hypothesize that patients with primary hyperaldosteronism are more     susceptible to ischemia-reperfusion injury.   "
100124|NCT01975597|"     This is a feasibility study to demonstrate the team's ability to collect bone marrow     aspirates and biopsies for research purposes from women with metastatic breast cancer.   "
99917|NCT01978301|"     This is a 3-arm randomised clinical enabling study, with no investigational product. Keloid     patients who are scheduled for surgical excision of one or more keloid scars (up to nine)     will be recruited to the study. The aim is to investigate how collagen synthesis within     keloid scars is affected by the current approved steroid treatment for keloids, triamcinolone     acetonide (TAC). The primary endpoint will be fractional collagen synthesis in keloids which     have received intra-lesional injections of TAC, placebo or no treatment prior to their     removal. Fractional collagen synthesis will be determined using an established isotope/mass     spectrometric technique which measures levels of deuterium incorporation into collagen     following administration of heavy water to the subject. In addition; keloid tissue samples     will be evaluated post surgery to identify further biomarkers of extracellular matrix     synthesis and degradation for application in future clinical studies. Subjects will complete     a screening visit and will then be randomised to receive three intra-lesional injections of     TAC or placebo, or no treatment, at an interval of 2-3 weeks. Subjects will be randomised to     different treatment sequences depending on the number of keloids they have scheduled for     surgery, in such a way that subjects with multiple keloids will receive different arms of     study treatment in their different keloids. Planned surgery for removal of their keloid(s)     will be performed at week 6-8. All subjects will receive daily heavy water (Deuterium oxide)     administration (twice daily or thrice daily as directed), with the first dose being taken at     the Week 2 clinic visit and the final dose being taken on the day prior to surgery. A     follow-up visit will be conducted at 1-4 weeks post-surgery.   "
99918|NCT01978288|"     This study tests the hypothesis that an increase in pathogenic bacteria within the infant     airway leads to increased airway inflammation, decreased airway function and ultimately     airway obstruction throughout the first one to two years of life.   "
100075|NCT01976234|"     Transfusion of RBC is associated with post operative infections. Our hypothesis is that     stored blood could be related with increased post operative infection risk. Surgical patients     transfused during the operation or immediately after will be included in our study. Patients     will receive fresh or old blood during the whole recovery.   "
99919|NCT01978275|"     Stimulating catheters have been introduced to reduce the incidence of secondary failure after     continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating     catheters is still controversial. Furthermore no volume-response study has compared the     success rates of the two techniques for continuous lumbar plexus block. The aim of this     prospective, randomized, blinded study is to detect if stimulating catheters decrease the     minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus     block (LPB) in 50% of patients compared with conventional non-stimulating catheters.   "
99920|NCT01978262|"     The purpose of this pilot research project is to look at the effect of the inactivated     influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response     known as cytokines or signal molecules. The investigators also want to see if the timing of     vaccine administration has any effect on women's reproductive hormones. The investigators     hypothesis is that influenza vaccine given right before ovulation may change the hormone     levels usually seen after ovulation. Thi   "
99921|NCT01978249|"     Short description for lay public, include brief statement of the study hypothesis   "
99922|NCT01978236|"     This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30     evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma     to the brain. All subjects in this study are required to have accessible extracranial     metastases and are agreeable to undergo repetitive biopsies. The first cohort of 15 subjects     will receive dabrafenib orally 150mg twice daily (BID) for 7 to 14 days prior to surgery     (Cohort A); the second cohort of 15 subjects will receive the combination of dabrafenib 150     mg BID and trametinib 2 mg once daily for 7 to 14 days prior to surgery (Cohort B). The     primary purpose of this study is to determine levels and distribution of dabrafenib, its     metabolites, and trametinib (Cohort B only) in parenchymal brain metastases, extracranial     metastases, and peripheral blood (plasma) within two cohorts of subjects with BRAF V600E/K     mutation-positive melanoma that has metastasized to the brain. All subjects will be followed     for survival and new anti-cancer therapy for a total of two years or until death or the     subject wishes to withdraw from further follow-up.   "
99923|NCT01978223|"     This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe     gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in     Venezuela and to assess the current disease burden after introduction of the vaccine.   "
99924|NCT01978210|"     This pilot study is designed to investigate the feasibility of comparing a standard     behavioral intervention and an innovative intervention that incorporates the use of a     wireless moisture alarm in training children with autism how to independently use the toilet     for urination. We hypothesize that the study protocol will be feasible, as measured through     review of achieved recruitment targets, successful randomization, and >80% retention of     subjects with com- plete data collection. Our second hypothesis is that therapists will     deliver experimental and standard behavioral treatment intervention with ≥80% fidelity and     parents in both intervention groups will adhere to the intervention with ≥80% fidelity. A     secondary aim of this study is to examine trends in outcome data by conducting a small RCT (N     = 30) of wireless moisture alarm and standard behavioral toilet training, with the hypothesis     that the moisture alarm intervention will result in fewer toileting accidents, a higher rate     of toileting success and greater parental satisfaction.   "
99925|NCT01978184|"     This is a randomized phase II trial that will examine the ability of the hydroxychloroquine     to improve the clinical activity of a pre-operative regimen of gemcitabine and nab-paclitaxel     in subjects with potentially resectable adenocarcinoma of the pancreas. Eligible subjects     will receive 2 cycles of gemcitabine and nab-paclitaxel (day 1, 8, 15) with or without     hydrocychloroquine followed by surgical resection. Primary endpoint will be histologic     response as graded by Evans criteria. Secondary endpoints will be CA19-9 response and PET     response. Pre and post treatment tissue biopsies will be obtained to assess for levels of     autophagy in tumor, liver and peripheral blood.   "
99926|NCT01978171|"     The investigators will determine which factors are predictive for the development and     severity of everolimus-induced interstitial lung disease and will develop a prediction model     based on these risk factors.   "
99927|NCT01978158|"     Oxygen is a widely available gas that is cheap, easy to get and extensively used in medicine.     From animal studies it has become apparent that increasing or lowering the degree of oxygen     in the blood, the inflammatory response can be altered. We will investigate of this is also     true in humans by increasing, lowering or keeping oxygen levels normal while giving healthy     subjects a short inflammatory stimulus.   "
99930|NCT01978119|"     This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week     non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg     capsule-based inhaler and FSC 250/50 mcg multi-dose inhaler each administered BID in adults     and adolescents with asthma. The primary objective of this study is to demonstrate that FSC     250/50 mcg administered BID by capsule-based inhaler is non-inferior compared to FSC 250/50     mcg administered BID by multi-dose inhaler . The study consists of six phases: Pre-screening,     Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 3 weeks),     Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for     each subject will be at least 31 weeks.   "
99931|NCT01978106|"     Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the     AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of     patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal     astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of     corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value     was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace     incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric     IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.   "
99932|NCT01978093|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK     Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and     Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in     infants and toddlers.   "
99935|NCT01978054|"     The purpose of this study is to identify and evaluate dissemination strategies to promote the     uptake of evidence-based cancer and other chronic disease prevention among state-level public     health practitioners. Dissemination strategies such as multi-day in-person training workshops     and electronic information exchange modalities are hypothesized to associate with improved     access and use of public health evidence and organizational supports for program and policy     decision making based on evidence-based public health.   "
99936|NCT01978041|"     The importance of fluoridated water to control caries is well recognized. Although the mode     of action of fluoridated water is known (related to a slight increase in fluoride     concentration in saliva/dental biofilm in individuals living in fluoridated areas), the     kinetics of fluoride concentration in saliva after ingestion of food prepared with     fluoridated water, either from fluoride remaining in the oral cavity after mastication, or     from fluoride returning from salivary secretion is not known in details. Therefore, the aim     of this study is to assess fluoride bioavailability after ingestion of food prepared with     fluoridated water. The study will be in vivo, crossover and double blind, in which 12 adult     volunteers will participate. In 4 experimental phases, volunteers will ingest: a. a typical     Brazilian meal cooked with non-fluoridated water (<0.1 ppm F); b. a typical Brazilian meal     cooked with fluoridated water (1 ppm F); c. non fluoridated water (<0.1 ppm F) and d.     fluoridated water (1 ppm F). Immediately before and 5, 10, 15, 30, 45, 60, 120, 180 minutes     after the ingestion, a blood sample will be collected by digital puncture, and a sample of     unstimulated saliva will be collected. Fluoride concentration in the samples will be     determined by an ion specific electrode adapted for microanalysis. Results will be analyzed     by ANOVA, with significance limit of 5%.   "
99937|NCT01978028|"     The primary efficacy objective of this study is to evaluate the effect of ferric     carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.   "
99938|NCT01978015|"     Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second     leading cause of world blindness. The treatment of glaucoma is mainly based in reducing     intraocular pressure (IOP) with topical medications. Many patients required two or more     medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs     (PGA) are frequently used in clinical practice because their additive effect in lowering IOP     levels. The aim of this study was to investigate the effects of fixed combinations of timolol     maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness     in pseudophakic patients with primary open-angle glaucoma (POAG).   "
99939|NCT01978002|"     Bladder pain and discomfort, as well as urinary urgency and frequency, are bothersome     symptoms seen frequently in the general population. Clinical diagnostic terms used to     describe these symptoms include interstitial cystitis (IC), bladder pain syndrome (BPS),     chronic prostatitis, and overactive bladder (OAB), but there is tremendous overlap between     these entities, and the distinction between them is based more on eminence than evidence.      Pain and/or sensory sensitivity has been suspected to play a role in the pathogenesis of both     bladder pain and urinary urgency/frequency. However, no previous studies have investigated     whether entities such as IC/BPS and OAB might merely represent different points in a     continuum of bladder sensory sensitivity. Moreover, we know of no studies that have directly     compared sensory sensitivity in the bladder to global (i.e. CNS-mediated) sensory     sensitivity.      In the study, a team of investigators with complementary expertise will perform a     population-based study assessing bladder and overall sensory sensitivity, in a cohort of     women representative of the population with respect to the entire continuum of bladder pain     (from none to severe), and symptoms of urgency/frequency. These individuals will undergo     urodynamics to measure sensory sensitivity in the bladder, as well as pressure pain and     auditory loudness thresholds. The Specific Aims are to demonstrate: 1) sensory sensitivity in     the bladder is related to sensory sensitivity elsewhere in the body, suggesting a CNS-driven     mechanism, and 2) individuals in the population with greater global sensory sensitivity will     display: a) more bladder pain, b) more urgency/frequency, and c) other symptoms of     centrally-mediated pain states, such as pain in regions other than the bladder, fatigue, and     insomnia.   "
100005|NCT01977144|"     The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS)     on patients with low ovarian reserve in an effort to improve success during in vitro     fertilization and decrease the time to successful pregnancy.   "
99940|NCT01977989|"     The purpose of this study is to study how well using a powdered form of the antibiotic,     vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented     spinal surgery for traumatic injury to the back.      Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating     certain kinds of bacteria. It is also used to prevent infections of the surgery site.      This will be a study in which the experimental treatment is compared to a standard (control)     treatment. It will be prospective in nature, meaning that it will follow patients forward in     time, and it will consist of a randomization process to determine who will receive the     experimental treatment versus the standard (control) treatment.      The study will take place at Regional Medical Center (The MED). 140 subjects will be     participating in this study.      The investigators hypothesize that the topical use of powder vancomycin will decrease the     rate of surgical site infection.   "
99941|NCT01977976|"     Implantation failure remains one of the major factors limiting success in IVF treatment. It     was postulated that the local injury to endometrium induces secretions of cytokines and     growth factors such as leukemia inhibitory factor, interleukin-11, and heparin-binding     EGF-like growth factor which enhance decidualisation and facilitate implantation. It may also     up-regulate the gene expressions related to endometrial receptivity and optimize the     endometrial development. In stimulated cycles, local injury to the proliferative endometrium     has been postulated to delay endometrial development thereby inducing synchronicity between     endometrium and embryo stage and facilitate implantation (Zhou et al, 2008; Almog et al,     2010; Gnainsky et al, 2010) The aim of the study is to determine whether endometrial injury     by endometrial biopsy in mid-secretory phase of the preceding cycle would improve the     on-going pregnancy rate in subfertile women undergoing IVF treatment.   "
100218|NCT01974362|"     In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic     Zirconia, compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially     stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has     less post-insertion complications after 1-Year follow-up ?   "
99942|NCT01977963|"     Thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. Side     effects are found in 1% - 5% of the patients1. One of the most serious side effect is     agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. This might lead to severe     infection and sometimes mortality. The underlying mechanism is unclear. An immune phenomenon     may be involved because the antigranulocyte antibodies or lymphocyte sensitized to     antithyroid drugs are found in these patients6,7. The recognition of major histocompatibility     complex class II peptide complexes by T lymphocytes is central to the development of immune     response. According to a report in 1996, the HLA DRB1*08032 allele is strongly associated     with susceptibility to methimazole-induced agranulocytosis20.      Recently, there are new techniques for genetics study. We aimed to identify the associated     genetic change of the agranulocytosis side effect of antithyroid drugs. First, we will look     at the classical human Leukocyte Antigen (HLA) loci, such as HLA-A, -B, -C, -DR, -DQ and -DP.     If no significant change is found in the above genes, we will consider whole exon sequencing     with next-generation sequencing, Statistic analysis will include appropriate linkage     analysis, association study, variation data analysis, pathway analysis. If we can identify     the genetic change and perform genetic examinations before prescription, we can avoid the     happening of severe side effects.   "
99943|NCT01977950|"     The purpose of this study is to estimate the prevalence of nutritional risk and examine     nutritional care practices in the hospitalized elderly at one large university hospital in     Norway.   "
99944|NCT01977937|"     The purpose of this study is to evaluate the patient experience when using gabapentin with     other pain control medications after posterior spinal fusion surgery for scoliosis in     adolescents. These results will be compared to patients who underwent the same procedure     during the study period and received the same standardized pain control regimen excluding     gabapentin. Effects on pain level, opioid use, satisfaction and narcotic use after discharge     from the hospital will be measured. Opioid side effects including nausea, sedation and     urinary retention (inability to empty one's bladder) will also be recorded.The null     hypotheses are as follows:        1. There is no significant difference in pain control when adding gabapentin to a          multimodal pain management protocol in pediatric post-operative posterior spinal fusion          patients.        2. There is no significant difference in the amount of opiate medication required for pain          control in pediatric post-operative posterior spinal fusion patients.   "
99945|NCT01977924|"     Severe obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity     and mortality. Endothelial dysfunction, an early marker of vascular disease has been     demonstrated in OSA. Regular treatment of OSA by continuous positive airway pressure (CPAP)     improves endothelial function and is associated with a reduction in cardiovascular risk.     Approximately 40% of patients with OSA are intolerant or insufficiently adherent to CPAP.     Alternative treatments or adjuvants to the CPAP are needed.      The polyphenols have demonstrated their effectiveness in improving endothelial function in     patients with CV disease. No randomized controlled studies have evaluated the impact of PPR     on the endothelial dysfunction associated with OSAHS.   "
99946|NCT01977911|"     This study aims to test a new groundbreaking treatment for narrowing of the voicebox and     upper windpipe, which can be due to injury, inflammatory disease or cancer treatment.     Narrowing of the voicebox or upper windpipe can leave patients dependant on a tracheostomy     tube to breath through (a tube or hole in the neck), which can require a high level of care     with regular hospital visits and can lead to recurrent chest infections. Regular surgical     procedures may be necessary to widen the airway. Speaking may be very difficult or not even     possible, breathing is usually a struggle and swallowing can also be affected. Patients feel     very tired all the time.      The new treatment tested by this study is an implant that will partially replace the voicebox     or upper windpipe in order to cure the narrowing. The implant is based on a human donor     voicebox or windpipe that has been processed with detergents and enzymes in order to remove     all the cells from the donor, leaving a 'scaffold' of connective tissue. The patient's own     stem cells are removed from the bone marrow, then are grown on the scaffold in the     laboratory. These cells will form the cartilage in the wall of the scaffold. A split skin     graft from the patient may be needed to line the inside of the implant. The implant can be     considered 'living' due to the cells grown on it, and this type of treatment is referred to     as 'tissue engineering' or 'regenerative medicine'.      Once these cells have attached and started to grow on the scaffold, it is ready to be     implanted into the patient, and an operation is performed which occurs in two separate     stages. The final stage of the operation involves removing the narrow section of voicebox or     upper windpipe and implanting the scaffold to reconstruct it. Patients will be followed up     for two years after this operation, with investigations such as CT scans, examination of the     voicebox and windpipe with a flexible camera (bronchoscopy) and blood tests performed at     specific times.      It is intended that this treatment will significantly improve patients' symptoms resulting in     better breathing, swallowing and voice function, reducing the need for repeated hospital     visits and procedures and enhancing patients' quality of life.   "
99947|NCT01977898|"     The purpose of this study is to evaluate the use of intrathecal morphine administration     following an unintentional dural puncture, to decrease the incidence of post dural puncture     headaches (PDPH) in obstetric patients.   "
109879|NCT01847742|"     To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the     trauma symptoms among Syrian Refugees.   "
99948|NCT01977885|"     Our greatest public health challenge is obesity and the co-morbidities of metabolic syndrome     (MetS). Age is an established risk factor for MetS and specific to women, data indicates that     the prevalence of MetS increases substantially with the menopausal transition with     postmenopausal women having a 60% increased risk of MetS. Menopause also contributes to     reductions in strength, physical function and often psychological well-being (e.g. fatigue).     Obese individuals also have: a) impaired immune function and chronic inflammatory responses     associated with changes in the white blood cell population in blood and fat tissues; and, b)     increased secretion of and signaling by proteins in their fat cells. Weight loss, which     requires an energy deficit through increased physical activity and/or caloric restriction     (EX+CR), reduces risk for MetS in older sedentary obese women by reducing insulin resistance     and chronic systemic inflammation. Science and clinical practice will be advanced by     examining the molecular mechanisms by which EX+CR affects risk for MetS in older women. The     primary aim is to determine if CD4+ T cells will report the differential epigenetic     reprogramming of relevant gene expression associated with metabolic indices resulting from     EX+CR induced weight loss in older women known to be at risk for MetS. This pilot data will     be used to generate an NIH proposal of the same topic. A secondary aim is to assess the     impact of weight loss on physical function and psychological well-being which will provide     pilot data for an additional grant proposal regarding weight management in postmenopausal     women.   "
100219|NCT01974349|"     Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244;     ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers   "
99949|NCT01977872|"     JointADventure: A worksite activity-diet intervention for chronic knee pain is a randomized     controlled trial evaluation of a physical activity and nutritional worksite intervention to     decrease symptoms and disability associated with knee osteoarthritis (OA), a major public     health problem and a leading cause of work disability and work absenteeism/presenteeism in     the US workforce.      The overarching goal of this project is to find an effective and sustainable intervention     strategy that can assist large populations of persons with or at risk for knee OA to attain     and maintain healthy dietary and physical activity behaviors. This project has to potential     to have a tremendous impact on improving symptoms and quality of life of persons with chronic     knee pain and decreasing the functional limitation, work absenteeism/presenteeism, and     soaring healthcare utilization associated with knee OA.   "
99950|NCT01977859|"     The purpose of this study is to collect data to help researchers better understand the     various causes of obesity, which may lead to the development of new obesity treatment     options.   "
99951|NCT01977846|"     Stargardt disease is currently an incurable and untreatable macular dystrophy that causes     severe visual loss in children and young adults, thereby causing enormous morbidity with     economic, psychological, emotional, and social implications. There are no FDA approved     therapeutic treatments for this disease. Therefore, the objective of this study is to collect     natural history data from a large population of children and adults in order to evaluate     possible efficacy measures for planned clinical trials.      Participants will be recruited from each Investigator's own patient population as the study     requires the availability of both multiyear retrospective data, as well as ongoing     prospectively collected data. A concurrent ancillary study (SMART study) is also being     conducted with a subset of the prospective study patients during their regular ProgSTAR study     visits to expand the collection of retinal images to include microperimetry measurements     gathered under scotopic (low light) conditions.   "
99952|NCT01977833|"     Enhanced insulin and GLP-1 postprandial response after morning meal versus evening meal,     might be underlying explanation of the beneficial effect of eating breakfast with reduced     dinner vs skipping breakfast on glycemic control and HbA1c in T2D patients.      To test this hypothesis and clarify whether glucose, insulin and GLP-1 postprandial responses     are different in the morning vs. in the afternoon, the investigators will compare in T2D     subjects in random order and in two separate days: the glucose, insulin and GLP-1     postprandial responses after breakfast, lunch and dinner with 2 isocaloric meal plans or test     diets, that differ in meal timing distribution The investigators hypothesize that GLP-1 and     insulin response after high calorie breakfast will be higher in comparison to GLP-1 and     insulin response after identical meal at evening   "
99953|NCT01977820|"     This is a Phase 2a multicenter, double-blind, placebo-controlled, randomized, 2-arm pilot     trial designed to assess the effect of sapropterin on cognitive abilities in young adults     with Phenylketonuria (PKU) over a 26-week treatment period.   "
99954|NCT01977807|"     This clinical study has been planned to evaluate the safety and effectiveness of common     treatment algorithms using 500 Hz laser repetition rate.   "
99955|NCT01977794|"     This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose     combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC     over monotherapies).   "
99956|NCT01977781|"     The purpose of this study is to evaluate the safety and tolerability of topical tacrolimus     0.05% twice a day in the treatment of ocular graft versus host disease (GVHD).   "
99957|NCT01977768|"     The purpose of the study is to identify optimally effective dose of whole-cell, heat-killed     Mycobacterium vaccae formulated as a pill and consequently carry out multi-country,     placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug     resistant (MDR-TB) and TB-HIV.   "
99958|NCT01977755|"     This study explores the potential cardioprotective properties of danegaptide when     administered to patients with ST-Segment elevation myocardial infarction.   "
99959|NCT01977742|"     Purpose: to investigate the hypothetical additive value of a sudden rest-exercise training     over the cardiac vagal of cardiac patients in a supervised exercise program.   "
99960|NCT01977729|"     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) in     combination with sertraline (SRT) is more effective than SRT alone in treating children and     adolescents with anxiety disorders (after an initial 8 weeks of CBT).   "
100006|NCT01977131|"     The aim of this study was to analyze the safety, pulmonary function, and imaging changes of     patients with silicosis treated with autologous bone marrow stromal cells with modification     by hepatocyte growth factor.   "
100125|NCT01975584|"     This is a pilot study. We are testing the physiologic, immune and chemical responses to     stress. We believe the results of all measures to stress will be blunted in schizophrenia     compared to healthy controls. We will test sex, early life stress and other factors on the     relationship to a stress response.   "
99961|NCT01977716|"     The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk     factors for loss of residual renal function, technique failure and mortality in chronic     kidney disease patients.      Secondary objectives are: To know the current rate of peritonitis in peritoneal dialysis     population and to understand the bacteriological profile of peritonitis.      To know the rate and risk factors other than peritonitis involved in the loss of residual     renal function.      To analyze the utility of alternative diagnostic tests, such as reagent strips, for early     detection of peritonitis when traditional tests are not available.      To analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative     measurements of peritoneal clearance and residual renal function.   "
99962|NCT01977703|"     We propose to study a strategy empirically applied for the past 6 months at a high volume     LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative     device programming strategy to maximize battery longevity, avoid inappropriate implantable     cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in     overall shock burden, and potentially avoid unnecessary device generator changes prior to     transplant. Avoiding CIED (cardiac implantable electronic device) change out device     procedures prior to transplant is desirable.   "
99964|NCT01977677|"     This pilot phase I/II trial studies the side effects and best dose of plerixafor after     radiation therapy and temozolomide and to see how well it works in treating patients with     newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking     blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor     after radiation therapy and temozolomide may be an effective treatment for high grade glioma.   "
99965|NCT01977664|"     Donated oocytes is from a patient with repeated oocyte maturation failure in IVF cycles.     Cytoplasm of matured metaphase II oocyte and active MPF were injected into the donated     oocytes.   "
99966|NCT01977651|"     The objective of this study is to evaluate the incidence of seizures and monitor the safety     of enzalutamide treatment in subjects with metastatic castration-resistant prostate cancer     known to have risk factor(s) for seizure.   "
99967|NCT01977638|"     The purpose of this study is to determine the highest dose of CXD101 (a novel histone     deacetylase inhibitor) that can be safely administered to patients with advanced tumours. The     study will also investigate the use of HR23B expression in tumour as a biomarker of response     to treatment with CXD101. Patients with solid tumours, lymphoma and myeloma can be considered     for this study.   "
99968|NCT01977625|"     This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on     executive function and prefrontal cortex activation in menopausal women ages 45-57, who     report subjective cognitive difficulties. This protocol will recruit women from Dr.     Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation     during performance of cognitive tasks specifically probing prefrontal cortex function.   "
99969|NCT01977612|"     Women with gynecologic cancers are often obese and have other risk factors for post-operative     wound separation. Data from obstetrics and orthopedic surgery literature have shown a     decreased risk of wound separation and complications when the skin is closed with suture as     compared to staples. Skin closure with either staples or suture is considered standard of     care. Traditionally, most wounds have been closed with staples given their ease of use and     quick application. In this randomized study the investigators plan to evaluate and compare     the complication rate associated with both standard closures.   "
99970|NCT01977599|"     Breast Cancer is the single most common cancer, and the third leading cause of cancer cancer     deaths, in the United Kingdom. Breast screening is able to detect breast cancer in the early     stages of development, during which time it is more easily treatable. Unfortunately, many     patients do not attend screening, and surveys issued to these women consistently report     forgetfulness as the primary reason for missing the appointment. Both telephone reminders     and postal reminders have been shown to reduce non-attendance, however, these are time     consuming and expensive.      Mobile telephones are becoming an increasingly popular tool for communication between     healthcare professionals and patients, one which might offer an inexpensive solution for     delivering reminders. Text message reminders have been able to prevent missed appointments in     other areas of healthcare, and the same might be true for breast screening.      The investigators are conducting a trial to confirm whether this is the case or not.      In this trial, the investigators will send some women a text message to reminder them of     their appointment, and other women no reminder for their appointment. The investigators will     then compare the number of women in each group that went to their breast screening     appointment.   "
99971|NCT01977586|"     The aim of this study is to assess whether functional magnetic resonance imaging (MRI)     techniques are able to detect which patients with metastatic renal cell carcinoma will derive     benefit from treatment with anti-angiogenic drugs early in their treatment. Early response     assessment would allow selection of the most appropriate treatment option for each individual     patient.   "
100007|NCT01977118|"     Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic     necrosis with or without peripancreatic collection.      Percutaneous catheter drainage successfully drains the liquefied component of pancreatic     necrosis while the solid component still remains undrained. This infected solid component of     pancreatic necrosis is probably responsible for failure of percutaneous catheter drainage     which demands surgical debridement.      Streptokinase is a protein secreted by several species of streptococci which can bind and     activate human plasminogen.      In the present study investigators plan to instill streptokinase locally in to the     collections of patients with severe acute pancreatitis via pigtail catheter inorder to     liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby     delays or obviates the need for necrosectomy.   "
100008|NCT01977105|"     This is a single-group feasibility pilot trial of a peer-based, social media intervention to     prevent obesity in infants.   "
99972|NCT01977573|"     This study will be conducted in approximately 228 subjects with anemia associated with CKD     who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1:     recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are     currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either     GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO     before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the     control arm. For those randomized to the control arm, the decision around whether the subject     requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose     to achieve and maintain Hgb concentrations within the target range should be based on     Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value     being considered. The study consists of a screening phase of at least 4 weeks, a 24-week     treatment phase and a follow-up visit that will occur approximately 4 weeks after completing     treatment. It is anticipated that the data generated will enable selection of the starting     dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.   "
99973|NCT01977560|"     The purpose of this study is to determine the effect of lifestyle intervention on metabolism     and blood sugar control in Type 2 Diabetics.   "
100332|NCT01972867|"     The purpose of this study is to evaluate the feasibility and short-term safety and     effectiveness of the NanoKnife™ System when used to ablate localized prostate cancer in low     risk subjects with organ-confined prostate cancer and a low risk of recurrence. This study     will evaluate the feasibility of the NanoKnife™ System as a focal therapy.   "
99974|NCT01977547|"     ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC     storage duration in 1538 critically ill children. Laboratory and observational evidence     points to serious concerns about the lack of safety and effectiveness of older RBCs,     especially in more vulnerable populations. Physicians and institutions have been     systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs     that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks     is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed     high quality evidence to answer the question do RBCs of reduced storage duration improve     outcomes? The ABC PICU Trial will conduct a RCT comparing development of New or Progressive     Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with     either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of     17-21 days).   "
99975|NCT01977534|"     The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS     for daily use in patients with de novo lesions in previously untreated vessels.   "
99976|NCT01977521|"     The present study aims to examine the efficacy of transcranial direct current stimulation on     the severity of auditory hallucinations.   "
99977|NCT01977508|"     Multicentre, prospective, observational post-market registry. To monitor and collect data on     the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access     Graft.   "
99978|NCT01977495|"     The investigator plans to assess enrollment rates among two different enrollment methods,     while providing a behavioral economic intervention to enhance the uptake of home-health     monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The     study is focusing on enrollment methods since the standard randomized control trial only     reaches 15% of the population. The study is seeking to understand the effectiveness of a     behavioral intervention, when rolled out in a larger population.   "
99979|NCT01977482|"     This study is intended to evaluate the dose-response relationship of GSK1278863 over the     first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks     to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia     associated with chronic kidney disease (CKD) who are switched from a stable dose of     recombinant human erythropoietin (rhEPO). The data generated will enable selection of the     starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.   "
99980|NCT01977469|"     The local and systemic manifestations that affect patients with Chronic Obstructive Pulmonary     Disease (COPD) cause severe dyspnoea and limitation of functional capacity, leading to     impairment in the performance of activities of daily living (ADL). The combination of aerobic     and resistance training, for both upper limbs (UL) and lower limbs (LL), appears to be the     physiologically most complete resource for improving quality of life and increased survival     of these patients. Therefore, the aim of the study is to assess the impact of aerobic and     resistance training of different intensities on the performance and dyspnoea during     activities of daily living and prediction of mortality in patients with COPD. There will be     include 30 COPD patients with moderate to severe obstruction, aged between 50-80 years of     both gender. All patients will undergo to the following assessments and reassessments:     history and anthropometric data, Scale London Chest Activity of Daily Living Scale (LCADL),     modified Medical Research Council (mMRC), BODE index, test peripheral muscle strength,     mobility and balance tests, 6-minute walk test (6MWT), Circuit ADL Test, 1 repetition maximum     (1RM) and Incremental Cardiopulmonary Testing (ICPT). Patients will be randomly divided into     two groups and undergo to the treatment program will consist of sessions lasting     approximately 1 hour, three times a week for 12 consecutive weeks, totaling 36 sessions. All     patients will undergo general stretching and aerobic training on a cycle ergometer with the     intensity between 70-80 % of the maximum load achieved in ICPT. After aerobic training, a     group of patients will achieve a protocol of low-intensity resistance training (LI-RT), with     emphasis on gaining muscle strength, and the other group will be submitted to a protocol of     high intensity (HI-RT), aiming greater gain in muscle strength. The calculation of the     intensity of training will be conducted by the 1RM test. After the training protocol, it is     expected to find improved performance and dyspnoea during activities of daily living and     reduction of BODE index for both groups, however, it is expected that the group of     low-intensity resistance training presents greater benefits in ADL.   "
99981|NCT01977456|"     The primary goal of this trial is to determine if individuals with acute ischemic stroke     treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV     eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome     than individuals treated with standard IV rt-PA alone.   "
99982|NCT01977443|"     A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept     study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase     adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of     APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical     resolution of EKC (objective and subjective assessments), presence of opacities, visual     acuity and frequency of second eye infections, and to assess the safety and tolerability of     APD-209 Eye drops in EKC infected eyes.   "
100009|NCT01977092|"     The goal of the study is to see if a Motivational Interviewing Case Management (MICM)     intervention will improve outcomes for respondents who are on probation or parole, at risk     for HIV and have recently entered a Sober Living House. The MICM will help respondents access     needed services, adapt to their new living environment, find and maintain work, address HIV     risk and treatment, and manage setbacks. The risk for HIV infection among criminal justice     offenders is significant, as is the need for stable, drug free housing in this population.     Our aim is to see if the MICM intervention in the context of drug free housing will improve     health outcomes, reduce recidivism, and increase service utilization for this population.   "
99983|NCT01977430|"     Introduction: Chronic kidney disease is characterized by a progressive deterioration of renal     function. At the end of the progression, when complications occur (overhydration, electrolyte     imbalances or retention of uremic toxins), a percentage of patients requiring renal     replacement therapy (haemodialysis). When starting the haemodialysis, the patient holds the     residual renal function (RRF) which is lost over time. To preserve the RRF, the patient is     treated with diuretics loops and / or thiazide diuretics. The effect of this treatment is     lost when renal function worsens. In this context, there are few studies that explore the use     and effectiveness of diuretics in patients on haemodialysis 2. Objectives and Hypothesis:      Hypothesis: The treatment with furosemide and hydrochlorothiazide in haemodialysis patients     with RRF could:        -  To decrease in weight gain between haemodialysis sessions.        -  To increase urine volume.        -  To decrease the ultrafiltration in haemodialysis sessions ( the long interdialytic          interval)      Main Objective:To asses the effect of combined hydrochlorothiazide-furosemide therapy on gain     weight between haemodialysis sessions in patients with RRF      Secondary Objective: To asses the effect of combined hydrochlorothiazide-furosemide therapy     on dialytic, clinical and analytical variables and use of the antihypertensive treatment      3. Methodology: Randomized open clinical trial to compare the effectiveness of the     administration of diuretics in haemodialysis patients with residual renal function in single     centre.      The population of study are patients with chronic renal disease in haemodialysis therapy that     they preserve residual renal function ( more 200ml daily of urine). It will be a simple     randomization, to asses the effect of combined hydrochlorothiazide-furosemide therapy      After a of 15 days washout without diuretic treatment, patients will be randomized to receive     or not receive combined diuretic treatment for 1 month. After a 1 month washout , the     patients will be receive or not the treatment according to cross over trial.   "
100333|NCT01972854|"     The objectives of this study are to evaluate the safety and efficacy of corneal collagen     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as     compared to placebo in impeding the progression of, and/or reducing, maximum corneal     curvature.   "
99984|NCT01977417|"     Prediabetes, characterized by elevated fasting blood sugar or exaggerated blood sugar     response to sugar ingestion, effects over 79 million adult Americans and is a precursor to     the development of Type 2 diabetes. Importantly, approximately 42% of Iowans (950,000) have     diabetes and 32% (670,000) have prediabetes with the majority of those with prediabetes going     undiagnosed. Adults with prediabetes demonstrate early signs of cardiovascular and nervous     system abnormalities and are at high risk for developing overt diabetes unless aggressive     lifestyle (weight loss, exercise) or pharmacological interventions are employed.     Interestingly, data in recent years has linked obesity and diabetes to chronic inflammation     of the blood vessels and brain areas that regulate blood pressure. Therefore, the current     study will test whether a commonly used aspirin-like anti-inflammatory drug called salsalate,     will improve blood vessel health and nervous system dysfunction in adults with prediabetes.     Eligible subjects will have measurements of blood pressure, blood vessel function in the arms     and eyes, assessments of nerve activity, and blood samples taken before and after 4 weeks of     ingesting an FDA approved aspirin-like drug called salsalate. The study is important because     it will identify a potentially new pharmacological strategy to treat vascular and nervous     system abnormalities in overweight and obese adults with early stage type 2 diabetes using an     inexpensive, generically available drug with an excellent safety record that has been used     for decades to treat chronic inflammatory conditions such as rheumatoid arthritis. If proven     effective, this will provide preliminary support for the concept of targeting inflammation as     a new clinical approach to treating early diabetes related complications. Furthermore, the     current pilot study will provide support for developing a larger clinical trial using     salsalate that could potentially then be extended to patients with type 2 diabetes and     cardiovascular disease, as well as lead to the development of new anti-inflammatory agents     with greater specificity for selective inflammatory pathways.   "
99985|NCT01977404|"     This study objective is to assess the nutritional status of Patients With Congestive Heart     Failure.   "
99986|NCT01977391|"     Diabetes mellitus is known to increase the risk of premature death in the general population.     In this study, the investigators examine the impact of body mass index (BMI) levels, waist     circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in     elderly Koreans.   "
99987|NCT01977378|"     A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release     Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult with     major depressive disorder.   "
99988|NCT01977365|"     Hypothesis N°1: The children growth promotion based on approach centered on their specific     needs enhances caretakers and health workers skills, knowledge and practices on     breastfeeding, complementary feeding and child care.      Hypothesis N°1: children growth promotion based on approach centered on their specific needs     approach improves children growth and health.   "
99989|NCT01977352|"     The purpose of this study is to compare the quality and duration of pain relief after     shoulder surgery provided by a single injection of liposomal bupivacaine versus standard     bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized     that the liposomal bupivacaine formulation will provide more effective pain relief than     standard bupivacaine.   "
99990|NCT01977339|"     The purpose of this study is to compare the quality and duration of pain relief after a total     knee replacement provided by a single shot of standard bupivacaine versus a single shot of     liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the     liposomal bupivacaine formulation will provide more effective pain relief than standard     bupivacaine.   "
99991|NCT01977326|"     The objective of this randomised controlled trial (RCT) is to determine the effectiveness and     cost-effectiveness of a task sharing counseling intervention for maternal depression in South     Africa(i.e. provided by non-specialist health workers)   "
99992|NCT01977313|"     It is known that with increasing age sexual desire is declining in women. Decreasing levels     of androgens are believed to have an influence, but cannot explain the loss of libido     completely. A possible explanation might be that the effect of the androgen is depending on     the functionality of the androgen receptor. It is known that this functionality is     genetically determined by the polymorphism of the androgen receptor gene. In the gene there     is a varying number of CAG-repeats: the longer the CAG-Repeat, the lower the functionality of     the androgen receptor, the lower the effect of the androgens. In this pilot study, the     investigators would like to invite 45 healthy heterosexual middle-aged women to the     University Hospital of Bern, where they answer questionnaires about their sexual function and     where they give a blood sample to assess the testosterone serum levels and the genetically     determined androgen receptor subtype.      The investigators believe that lower androgen levels and/or longer CAG-repeats in the     androgen receptor gene are related to lower libido scores in healthy middle-aged women.   "
99993|NCT01977300|"     Hypothesis: Continuation of an atypical antipsychotic medication in combination with a Mood     Stabilizer, following remission from an acute manic episode, lowers the rates of relapse and     recurrence of mood episodes compared to discontinuing the antipsychotics within days of     resolution of manic symptoms.   "
100010|NCT01977079|"     Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of     premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately     identify patients at high risk of PB. Currently, no clinical or biological marker is     recognized as the most reliable in predicting the real risk of AP in case of MAP.      The purpose of this study is to improve the knowledge of predictors of preterm delivery     compared with conventional blood markers by estimating serum procalcitonin according to     premature delivery or not in patients hospitalized for preterm labor .   "
100011|NCT01977066|"     The purpose of this study is to compare the effects of two specific exercise interventions     and one standard care control arm on physical functioning.The investigators expect that     supervised training is most beneficial to the patients. However, they also expect some     benefit for patients in the home-based training.   "
100012|NCT01977053|"     In health care, the phone has emerged as a clinical tool in its own right, especially for the     development of psychological support to patients and that, in many pathologies. Its potential     in the development of psycho-social support was quickly identified.      However, to our knowledge, no prospective, randomized studies have evaluated the impact of a     telephone call to both the anxiety and the management of side effects of neoadjuvant or     adjuvant chemotherapy.      The patient incomplete care by the hospital system and the general practitioner during     chemotherapy, as well as the lack of information and poor preparation and / or management of     side effects, are a source of distress and lead to a decrease quality of life for the patient     and his family.      We propose to determine on a population of 280 patients, the impact of two phone calls during     3 first inter-treatment intervals on the overall measure of mood states of the patient and     his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and     interpersonal relation). We will also study the gain in quality of life, on anxiety level,     frequency and severity of toxicities, as well as emotional comfort of the procedure.   "
99994|NCT01977287|"     This investigation consists of two parallel groups of participants who will follow the same     protocol. The aim of the study is to investigate the effects of using Functional Electrical     Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12     week period in people with MS who experience foot drop. Patients who are clinically     prescribed FES will be invited to participate in the FES arm of the study. Patients who are     clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will     be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks     before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6     weeks and 12 weeks of device use. Participants' walking will assessed using computerised     three dimensional motion analysis, which will provide a detailed description of the movements     (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk     and a two minute walk. Both gait analysis and the walking performance tests will be carried     out with and without an assistive device; apart from their first session where participants     will only be assessed without their assistive device.      Participants will be asked to wear an activity monitor for 7 days after each assessment. In     addition participants will be asked to complete four short standardised questionnaires (MS     walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of     life score) at each assessment.   "
99995|NCT01977274|"     Research of predictive clinical and biological factors in breast cancer : genomic, proteomic,     mutation   "
99996|NCT01977261|"     A prospective, randomised, controlled trial compared two different techniques of high tibial     osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu     plate. The clinical outcome and radiological results were examined at one year.   "
99997|NCT01977248|"     The SMART Program at Nationwide Children's Hospital is an interdisciplinary social skills     group that teaches children with autism spectrum disorders (ASD) ages 2-12 the fundamental     social skills necessary to build and maintain relationships. The manualized curriculum     addresses skills such as joint attention, eye contact, play, and peer engagement. Currently     individual goals are set for each child who participates and this is documented in the daily     treatment note. In order to research group outcomes, the investigators will use parent     questionnaires (an addition to current clinical practices) to measure changes in behavior     after each 12 week session for up to one year of treatment. The investigators hypothesize     that maladaptive behaviors will decrease and adaptive behaviors will increase in children     with ASD after participation in the SMART program.   "
99998|NCT01977235|"     As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is     related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene *28 (6/6 and 6/7)     and *6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene *28 (7/7) and     *6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out     the efficacy and side effect between two different dosages of irinotecan combined with     cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene *28 (6/6 and     6/7)and *6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene *28 (7/7) and *6     (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the     efficacy without increasing the side effect in the patients with UGT1A1 gene *28 (6/6 and     6/7)*6 (G/G and G/A).   "
99999|NCT01977222|"     Mechanisms that typically result in increased cardiac output, such as inotropic support,     increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation.     The thoracic pump is a contributor to venous return that has been largely unexplored in     patients with Fontan physiology. Inspiratory muscle training can improve the performance of     competitive athletes across a range of sports and can improve quality of life and functional     capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and     possibly by improving peripheral blood flow during exercise. One could surmise that the     effects of these changes would be particularly important in the Fontan population. The     investigators propose to study the effects of inspiratory muscle training on exercise and     pulmonary function parameters in a cohort of adult Fontan patients.      The investigators hypothesize that a 12-week program of inspiratory muscle training with an     inspiratory impedance threshold device will improve inspiratory muscle strength and     endurance, and that this will translate into improved exercise performance in patients with     Fontan physiology.   "
100000|NCT01977209|"     The investigators' experimental study found that gossypol was the natural inhibitor of     apyrimidinic endonuclease 1 (APE1) and clinical study observed that high expression of APE1     was relative to the platinum-resistance in non-small cell lung cancer. Thus the purpose of     this study is to find out whether gossypol can improve the sensitivity of cisplatin-based     chemotherapy in the non-small cell lung cancer with apurinic apyrimidinic endonuclease 1     (APE1) high expression   "
100001|NCT01977196|"     The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine     and immediate reactions within the first 30 minutes after injection.   "
100002|NCT01977183|"     The purpose of this clinical trial is to study the effects of potato resistant starch on the     microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels     will be measured and compared between elderly adults and in pre-elderly, adults from the     general public. A correlation between the use of potato resistant starch and specific     clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from     the general public will be studied.      Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years)     is less diverse and more prone to imbalance compared to adults (30-50 years) from the general     population and that this imbalance of the gut microflora in the elderly adults is partially     related to inadequate RS in their diet.      Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food     grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high     Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the     general population), thereby improving gut health and reducing the risk of diarrhea and/or     gut infection.   "
100003|NCT01977170|"     The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate     reactions within the first 30 minutes after injection.   "
100004|NCT01977157|"     Examination if the bioimpendanz measurement can be used for the determination of the alcohol     content in human blood.      Furthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer and     one blood test.   "
100016|NCT01977001|"     MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of     MigraineBoxTM will be studied in primary headaches in the emergency department. The user     simply reclines his/her head and neck into this device that has contours that support the     head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen     insert is placed inside. This will gradually cool the water surrounding the patient's head     and theoretically provide headache relief.   "
100017|NCT01976988|"     Patients undergoing major colorectal surgery are at increased risk for VTE (deep venous     thrombosis) compared with patients undergoing other general surgical procedures (Bergqvist et     al. Dis. Col. Rectum. 2006; 49: 1620-1628.)      The reported incidence of symptomatic VTE after colorectal surgery is approximately 4% (Monn,     F. et al. JACS. 216; 2013: 395-401). However, the reported incidence of VTE after colorectal     surgery in prospectively followed patients managed with perioperative venous     thromboprophylaxis undergoing screening venography prior to hospital discharge ranges from 9     to 20% (Bergovist et al. NEJM 346; 2002: 975-980; McLeod et al. Ann. Surg. 233; 2000:     438-444; ENOXACAN Study group. Brit. J. Surg. 84; 1997: 1099-1103.      The Surgical Care Improvement Project (SCIP) and the American College of Chest Physician     (ACCP) guidelines recommend that venous thromboprophylaxis be initiated within 24 hours of     surgery. However, it is believed that deep venous thrombosis occurs during surgery, rather     than in the postoperative period, justifying preoperative initiation of venous     thromboprophylaxis. This practice is accompanied with a theoretically higher risk of bleeding     complications.      Currently there is no consensus on the precise timing of VTE prophylaxis after major     colorectal surgery, as demonstrated by the vague guidelines established by the ACCP and SCIP.     Current studies on VTE prophylaxis report preoperative initiation of VTE prophylaxis.     However, majority of surgeons at our institution begin heparin postoperatively given concern     for bleeding complications with preoperative dosing of heparin.      The purpose of this study is to prospectively evaluate the incidence of VTE and major     bleeding complications in patients undergoing major colorectal surgery who are treated with     preoperative or postoperative venous thromboprophylaxis and to help establish more stringent     guidelines on the optimal timing of VTE prophylaxis.   "
100018|NCT01976975|"     This study aims to investigate reward learning across the mood disorder spectrum and to     investigate the predictive validity of reward learning for subsequent symptom severity.   "
100019|NCT01976962|"     To improve radiation therapy of prostate cancer, the investigators must be able to accurately     identify the tumour. By using advanced functional imaging techniques available on     state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the     prostate, the investigators can use advanced radiation therapy techniques to specifically     target the tumor and control it with as few radiotherapy clinic visits as possible. This is     different than current techniques which treat the whole prostate gland to the same dose,     delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to     the active tumor while still maintaining adequate radiation dose to the rest of the prostate,     the investigators hope to better control prostate cancer and reduce complications to nearby     normal tissues.   "
100020|NCT01976949|"     It is hypothesized that the treatment group will show greater improvements in quality of life     and mood disturbance compared to the control group and that greater levels of engagement with     the intervention materials will be associated with greater improvements in mood and quality     of life.   "
100021|NCT01976936|"     This trial will be a phase 2 randomized safety study in which ischemic stroke patients will     be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin     versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this     Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and     laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will     include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional     outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory     markers and lipid levels will also be assessed.   "
100022|NCT01976923|"     The purpose of this is study is to assess the efficacy of pre-operative intravitreal     bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing     operative time, complications, intra-operative and post-operative hemorrhage following small     gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge     PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD)     secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be     beneficial for membrane dissection in diabetic tractional retinal detachment with minimally     invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In     addition, post-operative rebleeding may be decreased.   "
100369|NCT01972386|"     To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of     lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.   "
100023|NCT01976910|"     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated     antineoplastic activities in human xenograft intracerebrally implanted tumor mouse models,     acceptable preclinical toxicities in mouse, rat and dog models; and no behavioral cognitive     impairment/neurotoxicities were noted in mouse and rat models.      The drug is ready for human use as an soy bean oil/lecithin/glycerin water emulsion, the     latter which has been documented - chemically and biologically to be stable and safe.     Patients are currently being enrolled and treated with the protocol.      Patients with advanced cancer, with or without central nervous system involvement will be     eligible for enrollment, providing the required blood and other eligibility requirements are     met.   "
100024|NCT01976897|"     The main objective of this study is to evaluate the relationship between the angle of knee     flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure     at the heel area (PtAl).   "
100025|NCT01976884|"     Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical     components of innate immunology, but recent studies showed that neutrophils might display     antigen presenting function and inhibit lymphocyte proliferation by expressing programmed     cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in     immunosuppression during sepsis remain unclear.   "
100026|NCT01976871|"     The primary objective is to demonstrate safety and tolerability of switching patients with     Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine.      As a secondary objective, the investigators will evaluate control of RLS symptoms on     rotigotine compared to the prior oral regimen.   "
100027|NCT01976858|"     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)     analogue that created on the basis of the Exenatide and modified by polyethylene glycol     (PEG).      This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.   "
100028|NCT01976845|"     The purpose of this research is:      To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety),     and amnesic (produces temporary lack of recall) effects of propofol or midazolam when     administered for preoperative medication (before administration of drugs that will put     patient to sleep) in comparison to placebo. This study is to test whether the use of the     pre-anesthesia medication measurably reduces anxiety in comparison to receiving no     pre-anesthesia medication prior to orthopedic procedures.      To assess the effect of propofol in comparison to placebo and midazolam on the ability to     recall (memory of):        -  when the doctor places the mask on patient's face prior to going to sleep        -  recall of 2 pictures        -  on your satisfaction with the anesthesia as well as postoperative side effects in          post-anesthesia care unit (PACU) e.g., nausea ,vomiting and sedation.   "
100029|NCT01976832|"     This study intends to use music and movement (MWM) to reduce anxiety and behavioral symptoms     of people with early dementia (PWD) and their family carers in the community. It also aims to     examine whether MWM can enhance the sleep quality of PWD and their family caregivers and     promote their well-being.      This is a mixed methods study with the quantitative paradigm being the main research     approached used. The quantitative arm will be a randomized controlled trial (RCT). The     qualitative arm will adopt a naturalistic approach through interviewing for data collection.     Recruited subjects from the community centres of non-government organizations (NGOs) will be     randomly allocated to the intervention and control group.      The outcome measures of the PWD will include Rating Anxiety in Dementia (RAID), Geriatric     Depression Scale (GDS), Neuropsychiatric Inventory Questionnaire (NPI-Q), Pittsburgh Sleep     Quality Index (PQSI), Quality of Life - Alzheimer's Disease (QOL-AD), Mini-Mental State     Examination (MMSE), Revised Life Event Scale (RLES), Modified Brathel Index (MBI) and     Non-pharmacological Therapy Experience Scale (NPTES), whereas the outcome measures of the     family caregivers will be Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety     Disorder 7 (GAD-7), Zarit Burden Scale (ZBD), Pittsburgh Sleep Quality Index (PSQI), Reverse     Life event Scale (RLES), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).      To address the research questions, data will be collected at baseline (T0), immediately     post-intervention at 8-weeks (T1), and 8 post-intervention (T2). The qualitative arm of this     study will contribute to the understanding of issues and effects of MWM as an intervention.     Its finding will complement the results obtained from the RCT.   "
100030|NCT01976819|"     This clinical investigation addresses the performance of a re-designed The current study aims     to investigate the next version of the TW speaking valve, in combination with both a 15mm and     22mm HME cassette.   "
100031|NCT01976806|"     The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in     the treatment of periodontitis in adults.   "
100032|NCT01976793|"     This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with an     initial antidepressant taken as monotherapy in patients in whom treatment was changed because     of suboptimal response at physician's discretion. This will address unmet medical needs of     patients with a depressive episode related to RDD (ICD-10, Version 2010), who have failed to     respond adequately to initial treatment with an antidepressant and contribute to an     understanding of the usual approaches that physicians adopt to monitor initial treatment     efficacy in RDD (Recurrent Depressive Disorder). The study will also focus on second-line     therapy in hard to treat patients, describing the different pharmacotherapeutic strategies.   "
100033|NCT01976780|"     This study aims to assess the degree of artemisinin resistance in adult and pediatric     subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study     treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ).   "
100034|NCT01976767|"     Cross-sectional study to characterize cohorts of subjects with asthma and healthy controls in     terms of clinical features, physiological measurements and non-invasive measurement of     biomarkers and develop phenotype handprints for adults with severe asthma   "
100035|NCT01976754|"     Septic patients in Intensive Care Unit always need mechanical ventilation and     conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of     wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult     septic patients of mechanical ventilation .   "
100225|NCT01974271|"     This prospective, multicenter, observational study will evaluate the impact of comorbidities     on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera     (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months     of treatment.   "
100036|NCT01976741|"     -  This is the first study where BAY1163877 is given to humans. Impact of the study is to          evaluate if patients with advanced solid cancers show advanced clinical benefit under          the treatment with the pan FGFR inhibitor. Patients (all comers) will receive the study          drug treatment in a dose-escalation scheme (no placebo group) to determine the safety,          tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative          bioavailability of liquid service formulation and tablets will be determined.        -  After the MTD is defined patients with solid tumors (all comers), lung cancer (lung          adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder          cancer will be enrolled according to their FGFR expression profile (biomarker          stratification).        -  The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic          parameters and tumor response of BAY1163877.        -  BAY1163877 will be given twice daily as oral application. Treatment will be stopped if          the tumor continues to grow, if side effects, which the patient cannot tolerate, occur          or if the patient decides to exit treatment.   "
100037|NCT01976728|"     To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic     hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the     OmniPod pump versus placebo   "
100051|NCT01976546|"     Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used     in the management of difficult airways.      Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not     always match with a higher intubation succes. To adress this matter the aim of this study is     gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape     intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).      The hypothesis is that intubation with this combination is easy and can be a good alternative     when using the McGrath videolaryngoscope in patients with predictors of difficult airway.   "
100038|NCT01976715|"     Background:      - The human immunodeficiency virus (HIV) causes acquired immune deficiency syndrome (AIDS).     Combination antiretroviral therapy (ART) drugs treat HIV infection. They generally decrease     the amount of HIV virus in the blood (called viral load) to very low levels. This happens     only if the drugs still fight HIV and if taken every day exactly as prescribed. When not     taken as directed, or if the ART drugs are not strong enough, the virus can become resistant     to them, and the ART will not work to control the virus. Researchers want to know how to     control HIV in people who can t lower their viral load with their current ART drugs.      Objective:      -<TAB>To better control HIV in people who can t get a lower viral load even with ART drugs     and to learn more about why the HIV is not under control.      Eligibility:        -  People at least 14 years old and with HIV.        -  People who have been on at least two combinations of ART drugs (including current ART).        -  People whose last two viral loads were greater than 1,000 copies/mL.      Design:        -  Participants will be screened with medical history, physical exam, and blood tests.        -  Participants will then have a baseline visit. They will have another physical exam,          blood tests, plus answer questions about what they know about HIV and ART, and how they          take their ART.        -  Participants will arrange to stay in the NIH hospital for 7 8 days.        -  They will take their medications as usual. At the time to take the ART drugs, they will          have to ask a nurse to bring them. If they forget, the nurse will bring them.        -  Participants will meet with a doctor, pharmacist, social worker and nurse to discuss          ways to help participants remember to take their drugs.        -  Participants will have blood drawn about every other day.        -  Researchers will study the test results. Some participants will be put on different ART          drugs. If that happens, participants will have another NIH hospital stay for 7-8 days.        -  Participants will have 4 follow-up visits over 12 weeks, then every 3 months for 2 years          or more.   "
100039|NCT01976702|"     This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an     Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and     attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the     original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen     relationship-based social competency skills of the original BST that were crucial in     sustaining adherence to protective behavior.   "
100040|NCT01976689|"     New-onset diabetes (NODAT) after solid organ transplantation is an important clinical     challenge associated to increased risk of cardiovascular (CV) events. In end-stage renal     disease (ESRD) patients, the impact of arterial stiffness on all-cause and CV mortality has     been clearly documented. Arterial stiffness has a pivotal role in the genesis of high blood     pressure (SBP), increased left ventricular hypertrophy (LVH), and consequently CV mortality.     Both LVH and arterial stiffness are independent determinants of CV disease in patients with     ESRD. The aim of this study is to evaluate the relationship between post-transplant new-onset     diabetes and arterial stiffness and left ventricular mass index (LVMI) in kidney transplant     recipients.   "
100041|NCT01976676|"     Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein     level more efficiently than folic acid. On the other hand, folic acid is currently an     important part of treatment in idiopathic recurrent abortion. There is no study comparing the     effectiveness of these supplements in the treatment of recurrent abortion. The aim of this     study is to compare the efficiency of these two agents in the treatment of recurrent     abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna     clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or     5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum     level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two     groups.   "
100042|NCT01976663|"     A prospective, multicenter, within-subject controlled study of the safety and effectiveness     of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial     folds (NLFs).   "
100043|NCT01976650|"     This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy     of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein     Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior     segment of the eye in clinical practice.   "
100044|NCT01976637|"     Leg compression is considered the basic treatment for superficial vein thrombosis (SVT).     However, its use is more or less based on subjective experience while scientific evidence for     its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical     symptoms when patients with SVT were treated with fixed compression bandages.      This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT     of the legs. The investigators hypothesis is that compression treatment is superior to no     compression in alleviating disease related clinical symptoms.   "
100045|NCT01976624|"     This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of     bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular     hypertension in Korea.   "
100046|NCT01976611|"     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and     efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.   "
100047|NCT01976598|"     To explore the optimal stimulation parameters and locations for sub-perception programming in     patients with previously implanted spinal cord stimulation systems for the treatment of     chronic back and/or leg pain.   "
100126|NCT01975571|"     The purpose of this study is to determine if adults and children with residual low-pitch     hearing in the severe hearing loss range can develop improved speech perception by combining     their residual acoustic hearing with electrical stimulation through a short cochlear implant.     The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be     stimulated electrically.   "
100048|NCT01976585|"     Our recent trials combining local radiotherapy with intratumoral administration of TLR     agonists - referred to as 'in situ vaccination' - for patients with low-grade lymphoma     demonstrated safety, induction of anti-tumor CD8 T cell responses and partial and complete     remissions of patients' non-irradiated sites of disease with complete remissions lasting from     months to more than three years.      This iteration of the in situ vaccine approach builds on our prior work in ways that should     improve its efficacy, by adding Flt3L and changing the toll-like receptors (TLR) agonist to     poly-ICLC -an optimal TLR agonist for the type of dendritic cells (DC) recruited by Flt3L.     The vaccine is thus in 3 phases:        1. intratumoral Flt3L administration recruits DC to the tumor        2. low-dose radiotherapy to release tumor antigens        3. intratumoral poly-ICLC administration activates tumor-antigen loaded DC   "
100049|NCT01976572|"     The primary objective is to assess the effects of colestilan on the pharmacokinetic profile     of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours     after the first daily dose of colestilan administered at doses of 5 g three times daily     compared to administration of candesartan cilexetil alone, in healthy subjects.   "
100050|NCT01976559|"     This research is being done to determine the accuracy of two noninvasive methods of measuring     the pressure of the spinal fluid, also known as intracranial pressure (ICP).   "
100056|NCT01976481|"     Our study aims to clarify the impact of the use of a standard sunbed according to new EU     guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan     to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new     recommendations for the exposure plan for different skin types according to EN 60335-2-27.      The use of a sunbed will be compared to a control group not using a sunbed in the observation     period.        -  Trial with medical device   "
100057|NCT01976468|"     The investigators hypothesize that a low number of SCC in OTR will metastasize.   "
100058|NCT01976455|"     The purpose of this study is to develop a novel, non-invasive method that will provide     personalized feedback during dietary interventions as a marker for compliance.   "
100059|NCT01976442|"     The purpose of this study is to determine whether a novel standard of care protocol, washing     red cell and platelet transfusions for younger patients with acute leukemia, has yielded     improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This     standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders.     2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.   "
100060|NCT01976429|"     This study will determine if newly developed and more standard tests of Eustachian tube     function can identify those persons who have ear pain (barotrauma) or develop middle-ear     inflammation and/or fluid (barotitis) when they are exposed to rapid changes in air pressure     as, for example, during airplane flights or scuba diving. Up to 150 adults and children     (10-50 years old) who fly or dive at least 1-2 times and experience ear pain or develop     middle-ear fluid during those activities and approximately 60 adults and children who fly or     dive but do not experience these problems will undergo Eustachian tube function testing     during simulated flight and diving.   "
100061|NCT01976416|"     Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute     painful episodes and reducing the need for blood transfusions in children with sickle cell     anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan     Africa, the areas with the most children with SCA.      The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for     children with SCA in a malaria endemic region within sub-Saharan Africa.   "
100062|NCT01976403|"     The main objective of this randomized controlled trial is to evaluate the effect of an     intervention formed as a pain booklet provided to patients at discharge from hospital     following cardiac surgery.      The primary objectives are to:        1. Develop and implement a pain booklet to improve pain management after cardiac surgery        2. Evaluate the effect of the pain booklet compared to a group of patients given usual care   "
100063|NCT01976390|"     This study is being done to compare the effectiveness and safety of two different kidney     transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in     the current standard immunosuppression regimen).   "
100064|NCT01976377|"     Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It     accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is     the hallmark of most human cancers, including HNSCC, and affects many cellular properties.     This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.   "
100226|NCT01974258|"     This study will evaluate the maximum tolerated dose and dose-limiting toxicities of     vemurafenib and/or cobimetinib when used with onartuzumab in cancer patients.   "
100065|NCT01976364|"     This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability     and efficacy of tofacitinib in subjects with active PsA who have previously participated in     randomized studies of tofacitinib for this indication.      This study will include a sub-study to evaluate the efficacy, safety and tolerability of     tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to     tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be     available to subjects who have completed at least 24 months of participation in the     open-label extension study and meet eligibility criteria for the sub-study.   "
100066|NCT01976351|"     Imaging enhanced endoscopy can improve the efficacy of screening of Barrett's esophagus and     predict its invasiveness. There is potentially molecular change over the Barrett's esophagus     in this Chinese population.      To evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus     and evaluation of invasiveness   "
100067|NCT01976338|"     Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in     patients with visual impairment due to macular edema secondary to BRVO   "
100068|NCT01976325|"     BRIEF SUMMARY      Canadians often visit areas with malaria where the preventative drug chloroquine no longer     works.      This leaves Canadians with the choice to use three different drugs to prevent malaria -     atovaquone-proguanil, doxycycline, or mefloquine. There are more than 400 cases of malaria     reported in Canada each year, a few which result in death. These cases mainly occur in people     who do not take malaria pills as directed.      Investigators have developed the Ottawa Malaria Decision Aid (OMDA), which is a bilingual     (English and French) resource used to support malaria prevention decision-making. The OMDA     contains plain language, fact-based information and helps individuals to reflect on their own     values and beliefs so that they can make the best decision for their situation.      In this randomized control study, the investigators will attempt to find out if using the     OMDA before visiting a travel clinic affects decisional conflict and the way pills are taken.     Consenting travellers will be assigned to standard care or standard care plus the malaria     decision aid. Both groups will complete three questionnaires before and after travel to look     at the impact on decisional conflict, preparation for decision-making, decisional regret and     pill taking behaviour.      Travelers' malaria can be prevented. It is our hope that by using different methods of     presenting information, specifically by utilizing the OMDA, there will be an increase in     adherence to appropriate malaria prophylaxis which will ultimately result in a decrease in     malaria cases that arrive in Canada. This will translate into a decreased use of health care     dollars and unnecessary deaths.      The Objectives of this study are to evaluate whether the malaria decision aid can be     integrated into the pre-travel consultation process and can:        -  improve a traveller's knowledge of malaria and prevention strategies;        -  improve a traveller's preparation for decision-making;        -  decrease decisional conflict; and        -  affect levels of adherence to prescribed malaria chemoprophylaxis.      The hypotheses of this study are that:        1. A decision aid will improve the quality of decision-making about malaria          chemoprophylaxis by decreasing decisional conflict and increasing knowledge about          malaria and malaria pills.        2. Better decision quality will result in a greater level of adherence to prescribed          malaria chemoprophylaxis.   "
100069|NCT01976312|"     Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients     with visual impairment due to macular edema secondary to CRVO   "
100070|NCT01976299|"     The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the     kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced     nephropathy (CIN).   "
100071|NCT01976286|"     The purpose of this study is to find out the safety and effectiveness of Glycolic Acid     Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.   "
100076|NCT01976221|"     The primary outcome in this study is more appropriate and comprehensive referrals and a more     seamless and smoother referral process with reduced workload for both partners. The referral     rates may be reduced by higher awareness of non-prioritized medical conditions. The use of     priority setting and waiting time according to the national prioritization guidelines can     give a higher correlation between GPs and hospital consultants about priority setting and     waiting time. In this study we will evaluate the effect of a multifaceted educational     intervention (a training program in priority setting) on the appropriateness and     comprehensiveness of referrals in terms of the agreement on priority setting and waiting time     between GPs and hospital consultants.   "
100077|NCT01976208|"     The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE     monoclonal antibody injection in patients with allergic asthma.   "
100078|NCT01976195|"     The project was undertaking by Qilu Hospital of Shandong University in China. In order to     report the efficacy and safety of thalidomide combining with high-dose dexamethasone for the     treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional     high-dose dexamethasone mono-therapy.   "
100079|NCT01976182|"     LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It     is an indolent disease, the main hematological or autoimmune complications lead to a     treatment in more than 60% of patients.      Investigators set up at the University Hospital of Rennes, a database of more than 300     patients with LGL leukemia from major French services that support this disease, and     published in 2010 the largest series of patients in the world (n = 229). However, the limited     heterogeneity and retrospective data collected, as all previously released, makes it     difficult the proposal of consensual treatment options. If first and second line treatments     are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin     A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are     mainly used in the first line. Invetigators just have in the literature data on about 100     patients treated with either of these drugs. Combining the results of our series with those     in the literature, invetigators estimate the respective overall response rate (RG) and     complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for     cyclophosphamide.      Thus, there are four objective in this study :        1. to compare the respective efficacies of methotrexate and cyclophosphamide when          administered as first-line therapies in patients suffering from T/NK LGL leukemia with          severe neutropenia or neutropenia associated with infections, and/or anemia requiring          transfusions, and/or auto-immune associated disease        2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide          for which a second line treatment is efficacious        3. to explore, in case of non-response to the first-line therapy, the efficacy of          ciclosporine A, the comparison being performed with the treatment which was not          administered in the first-line therapy        4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.   "
100656|NCT01968629|"     In this research study, the investigators are looking to see if MR imaging with Eovist     performed 24 hours after the injection of Eovist helps improve the identification and     characterization of focal liver tumors.   "
100080|NCT01976169|"     Standard of care:      Treatment with Trastuzumab      Experimental:      21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on     Days 5-18      Study Design and Methodology:      This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with     T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior     trastuzumab or other HER2-directed therapies.      The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes     on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how     well the subject tolerates the treatment.      A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of     PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18     of each 21 day cycle.      Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral)     Cohort 3 : PD-0332991 - 200 mg daily (oral)      The 3+3 design entails that if one patient out of the first three patients has a DLT, up to     three additional patients will be entered at that dose level      Treatment cycles will continue until disease progression or withdrawal from study.   "
100081|NCT01976156|"     The aims of this project are to determine if dietary supplementation with NOPE-EGCG     (PhosphoLeantm, 30mg NOPE+20mg EGCG per capsule) can:        -  rescue striatal function,        -  increase adherence to a diet,        -  reduce weight-gain after a diet,        -  improve performance on impulsivity, go/no-go tasks, and negative outcome learning, and        -  shift fat and sweet preference in overweight/obese human subjects in a double-blind          cross-over design.   "
100082|NCT01976143|"     The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc     interval in patients with advanced or metastatic solid tumors   "
100083|NCT01976130|"     Study hypothesis:      Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization     have lower levels of mucins and antimicrobial peptides in their airways   "
100084|NCT01976117|"     Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from     patients with COPD and bacterial infection   "
100085|NCT01976104|"     This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group     study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.     The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with     liver disease prior to an elective procedure to reduce the need for platelet transfusions or     any rescue procedure for bleeding due to procedural and post-procedural bleeding     complications. Participants will be enrolled into 2 cohorts according to mean baseline     platelet count and, within each baseline platelet count cohort will be further stratified by     risk of bleeding associated with the elective procedure (low, moderate, or high) and     hepatocellular carcinoma (HCC) status (Yes or No).   "
100086|NCT01976091|"     Dose escalation study of self-complementary (sc) AAVrh74.tMCK.hSGCA delivered to single leg     (low dose n=2) and bilaterally (n=6) via a major lower limb artery to the whole lower limb of     limb girdle muscular dystrophy type 2D (LGMD2D; alpha-sarcoglycan deficient) patients.   "
100104|NCT01975857|"     The broad aim of the proposed study is to evaluate the comprehensive benefit of a novel     mind-body therapeutic intervention, Mind-Body Bridging (MBB), in Veterans who suffer from     mTBI and sleep disturbance co-morbid with PTSD and/or pain at the VA Salt Lake City Health     Care System (VASLCHCS). Evidence for comprehensive benefit includes, but is not limited to,     the average difference in outcomes between MBB and an active control, sleep education (SED),     both integrated with the usual care for mTBI Veterans. The long-term goal of the proposed     project is to introduce, implement and establish mind-body intervention programs as a     behavioral health intervention modality that would serve as a generally sustainable health     care intervention program before, during, and after deployment for military personnel.   "
100087|NCT01976078|"     The death rate in children from the invasive fungal infection called aspergillosis is more     than 50%. Voriconazole is the first-line therapy for this infection. In a previous     publication the investigators have shown a highly significant relationship between     voriconazole plasma concentrations and survival. However, voriconazole dosing is currently     poorly established, and plasma drug exposure varies between children by 400% or more, even     after intravenous dosing. The objective of this study is to investigate the reasons for this     variability in voriconazole pharmacokinetics (PK).In two studies, the investigators will     enroll 80 children/adolescents receiving oral or intravenous voriconazole, divided by age     under 2 years (n=15), and 2-18 years (n=65). From each patient the investigators will collect     the following: 1) a blood sample for detection of several genetic changes known to affect     drug metabolizing enzyme (DME) activity; 2) up to 9 blood samples after a voriconazole dose     for measurement of voriconazole (PK sampling); 3) follow-up samples after each PK sampling     visit if necessary to adjust the dose so that voriconazole concentrations in the blood are     satisfactory (known as therapeutic drug monitoring or TDM). At the time of the voriconazole     dose prior to the PK sampling, we will also give single IV or oral (corresponding to the     route of voriconazole administration) low doses of esomeprazole (an antacid), midazolam (a     sedative), and ranitidine (an antacid) as a cocktail to test or probe DME activity. All of     these medications are used commonly in children already. The investigators will estimate DME     activity or phenotype using ratios of probe drug metabolite to parent drug concentrations,     while simultaneously quantifying the amount of DME genetic material (mRNA) and protein in     white blood cells. The investigators will test associations between DME activity, mRNA,     protein, voriconazole PK, age, sex, and degree of illness. The investigators will also use a     computer program to integrate all these data to develop a comprehensive model that will     predict blood concentrations of voriconazole in children of all ages, as well as assist     physicians and pharmacists to dose voriconazole more accurately.The total study duration for     each subject will be until after the TDM follow up visit, generally about one week.   "
100088|NCT01976065|"     This multi-center exploratory clinical trial is a randomized trial designed to test whether a     regenerative endodontic procedure using tissue engineering principles (REGENDO), or a     revascularization (REVASC) endodontic procedure, in comparison to standard apexification     treatment using a mineral trioxide aggregate barrier (apexification; APEX), produces a     significantly better composite clinical outcome for the treatment of immature permanent teeth     with pulpal necrosis.   "
100089|NCT01976052|"     Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be     evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by     polygraphy.   "
100090|NCT01976039|"     Professionals working in polluted areas may present increased clinical airways symptoms and     dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus     clearance in infants with bronchitis and bronchiolitis, and instillation the nasal cavity     with saline has been used to reduce nasal inflammation in rhinitis and sinusopathies. The aim     of this study was to assess the effects of RRC and RCC combined with saline (RRC+S) on nasal     mucociliary clearance (MCC), mucus surface property, cellularity and airways symptoms in     professional motorcyclists.   "
100098|NCT01975935|"     This study involves research about an investigational medicine called Amlexanox. The reason     for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance,     obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered     to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2     diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is     a placebo controlled study. There is a 50-50 chance that the patient may either receive the     study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors     will know if the patient is receiving the study drug or placebo.   "
101727|NCT01954589|"     A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and     pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor     antagonist in healthy male subjects.   "
100091|NCT01976026|"     The purpose of the DIVERT study is to provide a prudent, controlled clinical context for the     use of flow diversion, a promising option of yet unproven benefit, in the care of patients     with acute blood blister-like and dissecting intradural aneurysms. Hence DIVERT is a simple,     multicenter, randomized trial integrated into daily practice. DIVERT addresses the clinical     dilemma of whether the use of PED FD truly is a safe and effective alternative to best     standard treatment, defined as conventional methods of treatment or in some cases,     observation. Selection criteria are few, to facilitate the recruitment of most affected     patients confronted with these difficult aneurysms that their physician judges suitable for     PED FD. The trial does not obstruct clinical care, does not include extra tests or risks     beyond what is necessary and proven beneficial. Endpoints are simple, clinical, meaningful,     valuable and resistant to bias. Follow-up visits and tests are routine', imposing no extra     burden on clinical transactions. Data is collected in simple case-report forms filled by     physicians.   "
100092|NCT01976013|"     Up to now, only data about early and single coagulation screening exist in extreme low birth     weight infants (ELBW) infants. In neonatal practice, coagulation abnormality in preterm     babies is primarily investigated by measuring prothrombin time (PT). In fact, FVII activity,     which is an important determinant of PT, is strongly associated with bleeding risk. Thus, a     method to measure PT with small volume samples (10μL) provides the possibility for serial     monitoring even in ELBW infants (CoaguChek®XS, Roche Diagnostics, Vienna, Austria)).     Substitution of fesh frozen plasma seemed beneficial in ELBW infants and first trials with     rFVII revealed promising results in this patient population. Thus, coagulation monitoring     might lead to early and adequate therapy and therefore to a better outcome. The investigators     hypothesize that ELBW infants (<1000g birth weight) with primary severe prolongation of     prothrombin time or development of severe prothrombin prolongation during sequential     monitoring may have more frequent and more severe bleeding incidents (Intraventricular     haemorrhage and pulmonary haemorrhage). The investigators aim to explore whether monitoring     of PT can predict bleeding events in ELBW children.   "
100105|NCT01975844|"     Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron)     protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain     in target      Objectives:        1. Decreased variability of Hgb        2. Increase the % of patients in target range c Increase in time that Hgb remains target          range   "
100106|NCT01975831|"     This is a multicenter, open-label, study with a standard 3+3 dose-escalation phase, followed     by an expansion phase in subjects with solid tumors   "
100107|NCT01975818|"     Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus     epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75     and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be     based on the subject's Hb response and tolerability of the prior dose. Planned doses include     15, 25, 50, 75, 100,150 and 200 mg/day   "
100093|NCT01976000|"     Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the     well-known benefits and comparable oncological outcomes, it is still limited by a lack of     tactile sensation and a reduced operative field view. In addition, the inconsistency in the     number and course of the mesenteric vessels significantly influences the learning curve with     30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy     can be mapped using CT-angiography, and the images can be processed with rendering software     to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was     to assess the influence of visualizing the three-dimensional vascular anatomy on the learning     curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or     right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in     this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on     the learning curve, we considered 2 groups of two surgeons with different levels of     experience. In the first group (group A), the surgeons were able to view 3D reconstructions     before and during the surgery, while the surgeons in Group B were only able to view the 3D     reconstructions after surgery.   "
100094|NCT01975987|"     This study is designed to identify patients' features predictive of successful intubation     using the Bonfils fiberscope.      Our hypothesis is that some patients' characteristics are predictors of successful intubation     with the Bonfils fiberscope.   "
100095|NCT01975974|"     Obtaining peripheral vascular access in medical patients is a necessary procedure for many     healthcare providers. Peripheral vascular access is traditionally performed using palpation     or visual inspection to identify appropriate points of entry in the vasculature after which a     needle and catheter are threaded through the skin and surround fascia into the vessel of     interest. This procedure, one of the most common procedures in the medical field including     both artery and vein access, is not 100% successfully attempted. Operator skill heavily     influences peripheral vascular cannulation. (Frisch et al. 2013) However, certain patient     populations have difficult peripheral vessels to identify by palpation or visual inspection     and past operators would be forced to perform the procedure blind based on anatomical     landmarks. Recently, to aid vascular identification and increase cannulation success, a     number of alternative techniques for peripheral vascular access have been described including     ultrasound-guided.      Ultrasound-guided vascular access has been utilized in vascular access with improved success     rate. However, even with ultrasound guidance the first attempt success rate of cannulation     was only approximately 65%. A proposed failure of ultrasound guided peripheral vascular     access is most likely due to failure to advance the catheter into the vessel even the vessel     was successfully punctured. The investigators propose a specific technique and the positive     Target Sign as a means to obtain almost 100% successful peripheral vascular access.      The investigators plan to enroll 100 surgical patients in the above study and study     procedures will not differ from what a patient in the operating room under the care of     anesthesia faculty would receive. The above study is simply a way to identify the steps     regarding a specific technique.   "
100096|NCT01975961|"     This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and     rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two     groups enrolling healthy adult male and female subjects under fasting conditions.      Subjects will be admitted to the clinic in the evening before Day 1. All subjects will     receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin     co-administered in the morning on Day 1. All the subjects will remain in the clinical unit     until completion of all assessments on Day 2 including collection post-dose PK sample.     Subjects will return to the clinic for pharmacokinetic samples at scheduled time.      The two treatment periods will be separated by a washout period.   "
100097|NCT01975948|"     The aim of this study is to test the program's effectiveness in a primary care setting in     reducing stigma among medical personnel, increasing the comfort level of physicians and staff     in providing care to those living with mental illness, and in improving client well-being and     mental health.   "
100099|NCT01975922|"     The goal of the study is to examine the effects of teaching parents to use language support     strategies on language skills in toddlers with language delays. We hypothesize that children     whose parents who learn to use language support strategies at home will have greater language     skills than those children whose parents do not learn the strategies.   "
100100|NCT01975909|"     Spinocerebellar Ataxia (SCA) refers to a family of genetic diseases that cause progressive     problems with gait and balance, as well as other debilitating symptoms. This is a randomized     controlled pilot study to test a novel therapeutic intervention that uses noninvasive     magnetic brain stimulation to improve functional outcomes in patients with SCA. The study     will include quantitative evaluations of gait, balance, and brain physiology to examine     possible objective end-points for a future, larger multi-site clinical trial. The     investigators anticipate that patients receiving the real intervention will show a functional     gain.   "
100101|NCT01975896|"     This project will compare the preliminary efficacy of a novel school-delivered intervention,     mindfulness plus health education intervention, to health education alone on dietary and     physical activity habits in adolescents. This study has important public health implications     because of the negative consequences of unhealthy diets and lack of exercise on health, such     as obesity, cardiovascular disease and diabetes. If effective, this intervention has high     potential for translation to high school settings   "
100102|NCT01975883|"     Analyzing peri operative changes in blood glucose levels from non-diabetic patients     undergoing spine surgery   "
100103|NCT01975870|"     The main objective of the project is to make participants aware of their sedentary behavior     (prolonged sitting behavior) and then to encourage behavioral change through the use of an     innovative and fun application on a smartphone.   "
100146|NCT01975311|"     The purpose of this study is to determine if a lower back treatment would change the knee     pain intensity and the level of functional activities as well as the muscle activities in     people with anterior knee pain. The investigators hypothesized that the lower back treatment     may change the hip and knee muscle activities as well as reduce the knee pain intensity and     improve the functional activities in people with anterior knee pain.   "
100147|NCT01975298|"     The purpose of the study is to assess the efficacy, safety, and tolerability of two doses of     laquinimod compared to Avonex®   "
100108|NCT01975805|"     Currently there are no published studies comparing the efficacy of Chloraprep and     povidone-iodine in decreasing postoperative- wound infection in cesarean sections. However,     there have been studies involving other types of surgery that have compared the efficacy of     different types of preoperative cleansing agents in preventing postoperative wound infection.     These studies have shown that controversy exists over which antiseptic skin preparation is     the most effective for preventing postoperative surgical wound infections. The standard of     care at Los Angeles County Hospital for preoperative skin antiseptic in cesarean sections is     povidone- iodine 10% (betadine), however many other hospitals have made the transition to     using Chloraprep. In an attempt to improve on the current standard of care, we propose a     quality improvement prospective randomized study to compare the difference in postoperative     wound complications with the use of povidone- iodine and Chloraprep as a preoperative     antiseptic in cesarean sections. We hypothesize that Chloraprep will be better than Betadine     at reducing the incidence of positive bacterial cultures following cesarean sections.   "
100109|NCT01975792|"     The thymus gland is a specialized organ in the chest that plays a central role in the     adaptive immune system throughout development until puberty. In response to stress, the fetal     thymus gland may shrink, or involute. The investigators propose a prospective cohort study     that will enroll pregnant women admitted to labor and delivery for the management of preterm     labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on     sonographic thymus measurements, the investigators will develop a clinical prediction tool to     identify babies who are at increased risk for adverse neonatal outcomes. A reliable     non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has     the potential to affect clinical management, improve outcomes for premature babies, and     direct further research efforts.   "
100110|NCT01975779|"     To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in     healthy young Japanese men in comparison with Caucasian men.   "
100111|NCT01975766|"     This study investigates if using a very low carbohydrate diet during combined chemotherapy     and radiation therapy is safe and if it can be tolerated by patients.   "
100122|NCT01975623|"     VATS anatomical lung resection provides an effective minimally invasive treatment strategy     for stage I and II lung cancer. VATS lobectomy is associated with significantly less     postoperative atrial fibrillation, blood transfusion, renal failure, and other complications     when compared with lobectomy via thoracotomy.      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.      Currently, in spite of being a safe and effective technique in experienced hands, a minority     of anatomical pulmonary resections are being performed by VATS. The technical difficulty and     increased actual and perceived danger of VATS lobectomy is related to PA branch manipulation     and this is the main limitation for many thoracic surgeons regarding the adoption of VATS     lobectomy into their practise. Furthermore, the majority of VATS lobectomies are being     performed in high volume, academic medical centers with a resultant disparity in     socioeconomic status between those that undergo VATS versus open lobectomy. If we can find a     way to decrease the manipulation required by the surgeon on the PA branches, these procedures     will be safer, less stressful for the surgeon and therefore more prevalent for anatomical     pulmonary resections.   "
100112|NCT01975753|"     Acute pain relief in emergency setting is still a public health priority. Pain is the primary     reason for emergency room use, but the situation of oligo-analgesia persists in all     countries. Intravenous morphine titration has become the standard method for severe acute     pain management in the emergency department, but it is still insufficiently implemented.     Deviations from the recommended protocol are common: initial additional loading doses,     unusually extended intervals between bolus, premature discontinuation. Several factors     contribute to these difficulties: heaviness of its setting up, especially in overcrowding     case, procedure rigidity, high consumption of nursing time. This method requires a systematic     intravenously route, which has several inconvenients: algogenic procedures, coupled initial     diagnostic venous sampling (delay for analgesia), excessive medicalization of ambulatory     patients (risk of infection and less mobility in the emergency department). An alternative to     reduce the analgesic latency in emergency department, without losing the benefits of     tolerance and safety should be welcome. The inhaled route looks promising, but has yet not     been enough evaluated in adults, and even less in the emergency room. Aerosol techniques     change from one study to another (molecules, materials, doses, painful intensities included,     judgment criteria and assessment times). A morphine titration by aerosol therapy could be an     interesting alternative to the standard method disadvantages, using faster, painless and     easier procedures, leading to demedicalization.      To the need for stronger fundamentals, an additional study was designed in healthy     volunteers. The objective is to compare the titration of intravenous morphine titration     aerosol in moderate acute pain caused by electrostimulation.      To purchase this aim, we first need to determine accurately the smallest dose of effective     and well tolerated inhaled morphine, to provide the bolus dose we have to repeat by     titration, which is still currently unknown. This dose is called ED50, it's the effective     dose for at least 50% of healthy volunteers relieved. ED50 for intravenous morphine is also     needed to be established, unknown in this indication. The determination of these two parallel     ED50 would allow a reliable conversion factor between the two routes of administration for     morphine bolus, which can then be tested in comparative titrations. To validate our induced     pain model in healthy volunteers, we also have chosen to fix in these conditions the ED50 of     fentanyl that the effective dose by nebulization is better known. This study would also     describe the pharmacokinetics of inhaled morphine and its derivatives after a single spray.   "
100113|NCT01975740|"     Question: Does manual diaphragm release change kinematics and respiratory function of elderly     subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control     Group (CG) and 08 in the Intervention Group (IG).      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten     deep breaths, with a one minute interval between them. The CG underwent a sham protocol     (light touch), with same sets and time of interval.      Outcome measures: The groups were evaluated using spirometry, manovacuometry and     optoelectronic plethysmography (OEP), in that order, before and immediately after the     intervention.   "
100114|NCT01975727|"     Postoperative nausea and vomiting (PONV) are frequent after surgery and anaesthesia.     Dexamethasone is widely used as antiemetic for the prevention of PONV. Little is known about     the efficacy of antiemetic drugs for the treatment of established PONV symptoms. No single     randomised trial has been published so far that tests the efficacy of dexamethasone for the     treatment of established PONV symptoms. In this trial the investigators want to test the     antiemetic efficacy of three different doses of intravenous dexamethasone for the treatment     of established PONV symptoms. In adjunct protocols of this study the investigators aim to     establish a novel method to quantify the anti-nausea efficacy of an antiemetic drug, to study     pharmacogenetics of PONV, and to further our understanding on the smoking status as a     predictive factor of PONV.   "
100115|NCT01975714|"     Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product     composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This     new product is used as a once-daily topical ocular therapy for the reduction of elevated     intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and     that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is     an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as     bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The     comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was     recently launched in a number of countries in Europe and contains latanoprost in a new     preservative free formulation.      It is clinically important to compare these newly entered preservative free products with     respect to tolerability and efficacy. A better tolerability combined with maximum efficacy     will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to     the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy.      The hypothesis of the study is that monodose bimatoprost is more effective than monodose     latanoprost by at least 1 mmHg.      (AIBILI applied for an unrestricted grant from Allergan to perform this study)   "
100116|NCT01975701|"     This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to     adult patients with histologically confirmed GBM and/or other glioma subtypes with     FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.   "
100117|NCT01975688|"     To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics [PKs]     of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD])     when mild, moderate or severe oral mucositis is induced. This will be done by looking at the     effects of the body on the drug before and after oral mucositis is induced. The study     participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral     mucositis will be induced with radiotherapy and/or chemotherapy.   "
100118|NCT01975675|"     This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)     fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or     treatment-experienced Japanese participants with chronic genotype 1 HCV infection.     Participants receive 12 weeks of treatment and continue assessments during a 24-week     posttreatment follow-up period.   "
100119|NCT01975662|"     The aim of this study is to compare the efficacy of daptomycin treatment versus vancomycin     treatment in the treatment of methicillin resistant staphylococcus aureus (MRSA) bloodstream     infections (BSI) due to isolates with high vancomycin minimum inhibitory concentrations (MIC)     (i.e. > or equal to 1.5 ug/ml) in terms of reducing all-cause mortality.      Our secondary aim is to compare clinical failure rates of daptomycin treatment versus     vancomycin treatment and to compare time to microbiological clearance in patients treated     with daptomycin versus those treated with vancomycin.      Our primary hypothesis is that Daptomycin treatment is superior to vancomycin treatment in     reducing mortality from BSIs due to MRSA with high vancomycin MIC from 25% to 10%.   "
100120|NCT01975649|"     Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a     reduction in circulating androgen levels. The aim of this study is to evaluate the effects of     Tribulus Terrestris in premenopausal women with HSDD.   "
100121|NCT01975636|"     This is an open-label, single dose study in healthy male subjects.   "
100127|NCT01975558|"     Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic     profile in the exposed area and/or systemically and specific radiation biomarkers can be     identified in the respective matrices.      Purpose: This is a pilot study to verify in humans the results obtained from two animal     models exposed to ionizing gamma-radiation. The classification of patients results from the     treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer     undergoing high-dose radiotherapy are selected and compared to control group of age matched     healthy women.   "
100128|NCT01975545|"     Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized     that adding silver nanoparticles to fluor varnishes could promote remineralization of the     teeth. A split-plot randomized controlled trial will be performed to address this question.   "
100129|NCT01975532|"     The purpose of this study is to explore the relationship between deep brain stimulation     implantation site and DTI (diffusion tensor imaging) derived measures for the region and     later compare this to the clinical treatment outcomes.   "
100130|NCT01975519|"     The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a     recommended phase 2 dose for TRC105 when added to standard dose pazopanib in patients with     advanced soft tissue sarcoma. Up to 18 patients will be treated.      The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft     tissue sarcoma by RECIST 1.1 and estimate ORR in a separate cohort of patients with     angiosarcoma by RECIST 1.1. Up to 76 patients will be treated in phase 2, including a cohort     of up to 13 patients with angiosarcoma.   "
100131|NCT01975506|"     The purpose of this study is to identify the role of occupational therapy within Head Start     programs. Representatives within Head Start will be asked to participate in a nationwide     internet based survey identifying the amount and type of services provided within this area.     The Model of Human Occupation (MOHO) will also be included in the study by identifying     current use of the model and how it can be utilized in the future. In order to complete this     study to the fullest extent, we must begin by defining the Model of Human Occupation as well     as understanding the mission of the National Head Start Association. The vision of MOHO is to     support practice that is focused on occupation, client centered, holistic, evidence-based,     and complementary to other occupational therapy models. The mission of the National Head     Start Association is to coalesce, inspire and support the Head Start field as a leader in     early childhood development and education. This has lead researchers to perform the following     study: An examination of occupational therapy in the context of Head Start.   "
100148|NCT01975285|"     The purpose of this research study to evaluate the effects of dexamethasone as an addition to     peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on     length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain     scores, and patient satisfaction after foot and ankle procedures.   "
100149|NCT01975272|"     The purpose of this study is to determine whether oral or intravenous iron is effective in     the treatment of anaemia (iron-poor blood) after gynaecologic surgery.   "
100132|NCT01975493|"     The aim of NAPPA is to develop new models to improve our understanding of how children     process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens     used for children in the future. The study population will involve children and neonates who     need a penicillin antibiotic as part of their normal National Health Service (NHS) care, and     who also need blood tests or intravenous access. Therefore the antibiotic study can be done     without the need for any extra invasive procedures, and there will be no change to the     medication therapy received by participants. In addition, NAPPA will evaluate whether it is     feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper     (dried blood spot). This allows the sample to be stored and tested later on. NAPPA will     compare the level of the antibiotic using this method with the level measured in the usual     way, to show if this is a reliable method that could be used routinely in the future.   "
100133|NCT01975480|"     This is an open-label flexible-dose pilot study evaluating the efficacy, safety, and     tolerability of Pristiq (desvenlafaxine) in outpatient subjects diagnosed with Generalized     Anxiety Disorder (GAD) with or without comorbidities that are secondary to the GAD. Primary     trial objective is to evaluate the efficacy of Pristiq (desvenlafaxine) SNRI treatment 50 to     100 mg once daily in the treatment of GAD with or without comorbidities. Secondary trial     objective is to determine whether or not treatment outcome in GAD is related to changes in     cortical prefrontal activity of norepinephrine.   "
100134|NCT01975467|"     The objective of this post-market clinical study is to compare one to three year post     treatment results, range of motion, strength, patient related functional outcomes and patient     satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to     nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.   "
100135|NCT01975454|"     Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula. Experimental studies     have confirmed the anti-cancer potential of TLBZT against colorectal cancer. This trial will     evaluate the safety and efficacy of TLBZT based herbal therapy in combination with     chemotherapy in patients with metastatic colorectal cancer.   "
100136|NCT01975441|"     This study will determine if a combination of 3 drugs used to treat the infection that cause     lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing     or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat     this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM)     and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic     filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to     treat LF.   "
100137|NCT01975428|"     People with chronic diseases such as diabetes, hypertension (high blood pressure) and cardiac     (heart) arrhythmias tend to go to the doctor more often and have more tests done than those     without those diseases. This can lead to increasing costs of healthcare and extra visits to     doctors and healthcare facilities.      There are now medical devices that can be used at home to monitor blood sugar, blood     pressure, heart rhythms as well as other measurements. There have been some studies which     show that when people take their own health readings, they are better able to control their     disease, stay healthier and go to the doctor less often. In order to participate in the study     participants will have been diagnosed with 1 or more of the following: Diabetes,     Hypertension, Cardiac Arrhythmias.      This study is designed to test those devices and see if they can help participants stay     healthier through the recording and tracking of health measurements. Investigators will also     be testing how easy it is to use these devices and whether or how easy it is to fit them in     their daily schedule. Participants will be given an iPhone for use during the study and their     recordings will be stored and displayed on the phone.   "
104189|NCT01922362|"     To compare the efficacy and safety of negative pressure drainage system with controls     (indirect saline soaks) in the coverage of recipient site wounds of split-thickness skin     graft.   "
100138|NCT01975415|"     This study will investigate the acute response to meditation during a week-long meditation     retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of     numerous biometric parameters in selected cohorts of experienced and novice meditators during     periods of meditation and specific breathing techniques. Comparisons between cohorts as well     as over time will allow for the identification of meditation and/or breathing-related     changes.   "
100139|NCT01975402|"     We will evaluate the end to end remote monitoring system in a less controlled environment and     concurrently develop the infrastructure to support the back end of the system   "
100140|NCT01975389|"     This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to     placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular     death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization     in high risk subjects who are receiving background lipid lowering therapy and have     cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL     (3.4 mmol/L).   "
100141|NCT01975376|"     This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to     placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular     death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization,     in high risk subjects who are receiving background lipid lowering therapy and have     cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL     (2.6 mmol/L).   "
100142|NCT01975363|"     This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in     reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer.     Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of     developing breast cancer.   "
100143|NCT01975350|"     There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium     inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.   "
100144|NCT01975337|"     The primary objective of the study was to compare the single dose pharmacokinetics of     alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of     matched healthy subjects. The secondary objective was to evaluate the safety and tolerability     of a single dose of alisporivir when administered to subjects with ESRD.   "
100145|NCT01975324|"     Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had     nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.   "
100150|NCT01975259|"     Most Cystic fibrosis (CF) patients now commonly live well into adulthood, this means they are     progressively accumulating damage to the insulin-secreting cells inside their pancreas. This     explains why most adult patients have some degree of abnormal sugar regulation & rates of     diabetes rise significantly with age. CF related diabetes is categorically different from     other types of diabetes & its development is serious as it heralds a faster decline in lung     function & a reduced life expectancy.      The hallmark of abnormal sugar handling in CF is high glucose levels after meals as the     damaged pancreas responds abnormally slowly. Over 70% of the initial response of a healthy     pancreas is induced, not by glucose alone, but by hormones released from the bowel known as     incretins. We want to establish whether incretins are important in blood sugar handling in CF     as specific drugs that enhance their effect are now available.      The study hypothesis is that the incretin system will function normally in patients with     Cystic Fibrosis. To show this we will measure how much insulin secretion is dependant on     incretin hormones in CF patients by comparing levels after a sugary drink test and then an     intravenous glucose drip test (run at a rate that mimics the blood sugar levels obtained     during the first test to make it a fair comparison ) - as incretins will only be produced in     the first test when the sugar passes through the bowel any extra insulin produced will be due     to these hormones. To detect resistance to the incretin hormones we will separately measure     responses to direct infusions of the hormones themselves. We will explore which components of     meals cause incretin hormone release from the bowel wall by measuring blood levels after     different types of meals are consumed. Finally we will measure levels of the enzyme that     breaks down the incretin hormones (DPP-4) to know if they are deactivated more quickly in     people with CF. By describing the incretin system in CF we will considerably improve our     understanding of this important condition as well as potentially highlighting new ways to     treat it.   "
100151|NCT01975246|"     This is a multi-centre, randomised, double-blind, active-controlled, parallel-group     comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg     +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+     amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the     double-blind period in essential hypertensive patients who fail to respond adequately to     telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a     6-week open-label run-in period taking T80/A5 mg.   "
100152|NCT01975233|"     An observational post-market, open label, multicenter Observatory. The decision to use a WEB     device to treat the patients has been made before and independently of the decision to     include the patient in the French Observatory.   "
100153|NCT01975220|"     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed     fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single     tablets of empagliflozin and metformin when administered singularly.   "
100169|NCT01975012|"     Development of tolerable and effective antiretroviral (ARV) drugs for use in children and     adolescents remains a high priority. First-line therapy with non-nucleoside reverse     transcriptase inhibitors (NNRTIs) has proven to be effective for HIV-1-infected infants,     children, and adolescents. This study will evaluate the safety, effectiveness, and dosing     levels of the NNRTI rilpivirine (RPV) when given with two other ARV drugs in treatment-naive,     HIV-1-infected children less than 12 years of age.   "
100154|NCT01975207|"     To determine if treatment of significant depressive symptoms identified in individuals     attending a family practice improves either psychiatric outcome, overall health care costs,     or Quality of Life (QOL). Two previously developed treatment approaches - an internet-based     approach and a comprehensive depression pathway - will be compared to two control groups     (those who have treatment as usual after screening for depression and measurement of QOL, and     a second control group who will have QOL data only collected). The investigators hope to help     Alberta Health Services identify which approach is best as rapidly as possible so that the     best approach can be implemented throughout the province of Alberta.   "
100155|NCT01975194|"     This study will assess the rate at which rosuvastatin will achieve LDL targets in African     American patients with previous history of stroke or TIA.   "
100156|NCT01975181|"     The Cardiovascular Health Program (CHP) Registry seeks to improve the cardiovascular disease     (CVD) risk profile of subjects through therapeutic lifestyle change using an integrative     model of medicine.   "
100157|NCT01975168|"     A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged     above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2     groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2     receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of     washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser     acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide     Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds     every time, 3 times per week. The measurements of outcomes are performed in the beginning,     weekly during treatment, and monthly after treatment for 3 months.   "
100158|NCT01975155|"     Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten     free diet is the only available therapy but few is known about its nutrient content and     mycotoxin exposure.   "
100159|NCT01975142|"     Patients with metastatic breast cancer considered HER2 negative are screened for     HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is     detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II     with an adaptive design.   "
100160|NCT01975129|"     This study aims to evaluate the uptake of oxytocin following intravaginal administration of     Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after     vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70     years old with vaginal atrophy will be included and will self-administer Vagitocin     intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a     single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels     after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at     timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours,     relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic     variables will be calculated. The % of oxytocin which was absorbed following vaginal     administration (bioavailability)will also be calculated.   "
100161|NCT01975116|"     This phase I trial studies the side effects and best dose of azurin-derived cell-penetrating     peptide p28 (p28) in treating patients with recurrent or progressive central nervous system     tumors. Drugs used in chemotherapy, such as azurin-derived cell-penetrating peptide p28, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing.   "
100162|NCT01975103|"     This trial seeks to prove the safety and efficacy of photothermal stimulation treatment to     diabetic macular edema, chronic central serous retinopathy, macular edema secondary to branch     retinal vein occlusion and macular telangiectasia.   "
100164|NCT01975077|"     Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison     MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1,     2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor     xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and     efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these     2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and     regimen in phase II/III study.   "
100165|NCT01975064|"     The purpose of this study is to determine whether anesthesia maintained with propofol results     in better one- and five-year-survival than anesthesia maintained with sevoflurane.   "
100166|NCT01975051|"     We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL;     anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its     pathogenesis & PKDL patients are genetically predisposed; diagnostic tool based on     immunofluorescence technique will be more sensitive than slit skin examination for diagnosis     of PKDL.   "
100167|NCT01975038|"     Determining Fitzpatrick skin phototypes (FST) allows physicians to assess a person's risk of     developing sunburn, and thus the need for sun protection to prevent the development of skin     cancer. Reflectance spectrophotometry objectively measures the melanin index (MI) and can     assist in determining the accuracy of self-reported FST compared with     dermatologist-determined FST. At present, we seek to determine the accuracy of an adapted     Skin Sun Sensitivity Scale for individuals of all pigmentation varieties (FST I through VI)     as compared with spectrophotometric measurements assessing FST. Our principal objective is to     correlate the MI under usual conditions by spectrophotometry with the adapted Fitzpatrick SPT     as determined by the patients' responses to the adapted questionnaire.   "
100168|NCT01975025|"     The aim of this clinical research project is to test the hypothesis that daily dialysis has     favorable effects on the calcification propensity of human serum, when determined by the     investigators' newly developed in vitro serum test. The investigators' hypothesis is that     shorter interdialytic intervals will result in an improved calcification propensity of serum.     The determination of serum calcification has the potential to become a novel measure of     dialysis quality in the future.   "
100223|NCT01974297|"     The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg     with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals     with atorvastatin 10mg monotherapy.   "
100170|NCT01974999|"     This study is a multicenter, non-randomized, retrospective study to collect long term (5     years post-transplant) clinical outcome data to test whether the results of the noninvasive     immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first     six-month post-transplant is predictive of 5-year outcomes. Each center will complete a     retrospective chart review for the data on patient survival, graft survival and renal     function.   "
100171|NCT01974986|"     Athletes participating in multiple training sessions a day can be at increased risk of     suboptimal hydration and heat illness during their second training session, especially when     the environment is hot and humid. With the exception of the absolute volume of water     delivered by a rehydration beverage, characteristics of the beverage consumed play a role in     the recovery and completeness of rehydration. The amount of sodium in the beverage has been     shown to be a primary factor in rehydration. Recently, an effect of the carbohydrate     concentration of the beverage was been reported, with its effects mediated by the renal     system in response to elevated serum insulin. The purpose of this study is to compare sodium     and carbohydrate effects on rehydration and recovery.   "
100172|NCT01974973|"     The purpose of this study was to study the effect of stem cell therapy on common symptoms in     patients with autism spectrum disorders   "
100173|NCT01974947|"     Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who     conduct their sperm test through their diagnosis of infertility   "
100174|NCT01974934|"     To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression.     Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change     in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression     Scale. The primary efficacy measure of cognition will be the Montreal Cognitive Assessment     and analysis of change between baseline and 12-week scores.      To evaluate the effectiveness of desvenlafaxine as a first-line treatment for vascular     depression in a sub-group of patients who have experienced a TIA greater than 6 weeks prior     to baseline. Mean differences between baseline and 12-week efficacy measures will be examined     within the sub-group.   "
100175|NCT01974921|"     The purpose of this study is to evaluate clinical and histological response to bronchial     thermoplasty in severe asthma patients.   "
100176|NCT01974908|"     This study involves recording electrical signals inside the heart during an ablation     procedure. It is thought that by studying these electrical signals in detail the     investigators may be able to better identify and treat patients at risk of Ventricular     Tachycardia (VT).      VT is where the lower chambers (ventricles) of your heart beat fast and this condition can be     life-threatening. An ablation procedure is performed in patients who have VT despite the best     treatment available with tablets.      Cardiac ablation involves interrupting the abnormal electrical signals, which cause VT, by     applying a type of electrical energy through a catheter. An important part of the ablation     procedure is the identification of the exact part of the heart muscle responsible for causing     the VT. This typically involves sampling the electrical signals in lots of different areas of     the heart, which allows the construction of computer generated 3 dimensional pictures of the     structure and the electrical circuits inside the ventricle. Recent research has identified a     new method to interpret these electrical signals (called Fibrillatory Factor - FF), which may     allow better identification of the area within the ventricle that should be ablated.      A standard VT ablation will often involve us controlling the heart-beat by pacing the heart     through 1 of the investigators catheters within the heart. The electrical response to pacing     at different heart rates can often provide your doctor with information to help the ablation.     This study will involve an additional period of pacing at different heart rates, during which     the electrical response is measured in different areas around the ventricle. This will allow     us to calculate areas of the ventricle, which the investigators new measure FF would predict     to be the source of the VT. In the future this may then allow us to better identify patients     who are at risk of VT, and to better locate the area that needs to be ablated.   "
100177|NCT01974895|"     The purpose of this study is to evaluate the immunogenicity and safety of the new influenza     vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)     in children 6 to 35 months of age.   "
100220|NCT01974336|"     The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has     been identified by some studies in children without short bowel syndrome(SBS).Most of the     adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the     lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in     our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in     adults with short bowel syndrome.   "
100178|NCT01974882|"     Postoperative pain is an unavoidable consequence of open abdominal surgery. Although     cryotherapy, the application of ice to a surgical wound site, has been shown to be effective     in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not     been assessed in patients who undergo major open abdominal operations. We hypothesized that     patients who receive cryotherapy would report lower pain scores as a primary outcome measure.     This would result in less narcotic analgesia usage, and shorter hospital stays as secondary     outcome measures.   "
100179|NCT01974869|"     Background: The immunologic response to stress is regulated by the cytokines. Anti-Tumor     Necrosis Factor-α agents are antibodies directed against a key cytokine in the process     angiogenesis and collagen synthesis. It is not known whether they intervene with surgical     stress response increasing the rate of postoperative complications.      Method: Un-blinded prospective, non-interventional cohort single centre study including all     the patients with Crohn's disease and Ulcerative Colitis undergoing abdominal surgery.     Immunological and endocrinological parameters will measured in blood samples taken from these     patients before and after surgery. Power calculations showed that 17 patients in each arm are     needed.   "
100180|NCT01974856|"     The primary objective of this study is to assess the extent to which the Prosigna™ Breast     Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment     recommendations regarding adjuvant chemotherapy and actual treatments received for patients     with early-stage breast cancer.   "
100181|NCT01974843|"     Caudal block is the regional anesthetic technique that is used most frequently in pediatric     surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of     analgesia but ideal combination were not found that has minimal adverse effect. The aim of     this study was to compare the postoperative analgesic efficacy of equal concentrations of     bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing     minor urological surgery.   "
100182|NCT01974830|"     This is a longitudinal, observational, non-interventional registry study, designed to collect     both retrospective and prospective real world data, on patients receiving Alpha-1     augmentation therapy in the home through Coram Specialty Infusion.The data will be collected     from standard Coram homecare forms, as well as patient reported case forms.   "
100183|NCT01974817|"     The purpose of the study is to determine the response of 13-valent conjugate pneumococcal     vaccine in patients 50 years or older with end stage renal disease on dialysis.      The study will also try to determine Streptococcus pneumoniae colonization in patients 50     years or older with end stage renal disease on dialysis.   "
100224|NCT01974284|"     We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid     cancer.   "
102147|NCT01949285|"     This study is to determine if non-invasive electrical stimulation of the spinal cord can be     used to: 1) assess spared function following a spinal cord injury; and 2) be use for     rehabilitation.   "
100184|NCT01974804|"     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the     body using magnetic field and radio frequency pulses that can not be felt. The purpose of     this study is to determine if new imaging methods can help tumor evaluation in the brain. The     extra images will be obtained using diffusion and perfusion MRI techniques to assess early     treatment response in patients with brain metastasis, and will be compared to methods     currently being used.   "
100185|NCT01974791|"     The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure     Treatment (GET Living) to target elevated pain-related fears in children with chronic pain.     Pain-related fear is an important psychological factor associated with poor outcomes in     children suffering with chronic pain. To examine the efficacy of GET Living in addressing     pain-related fears the investigators propose to use a sequential replicated randomized     single-case experimental phase design with multiple measures. The specific aims are to 1)     evaluate the effectiveness and acceptability of individually tailored GET Living for children     with high pain-related fear and functional disability and 2) define anatomical and resting     state connectivity patterns in the brains of children and adolescents with complex chronic     pain prior to and after participation in GET Living.   "
100186|NCT01974778|"     Brown adipose (fat) tissue (BAT) is a type of fat tissue found in certain small rodents and     human babies that is capable of extremely high rates of energy burning. We now know that in     adult humans it is present and also able to burn energy.      In addition to increased energy expenditure during cold exposure, energy burning is also     increased after consuming a meal. Animal studies have shown that part of this additional     energy consumption is contributed by BAT. In the present study we will aim to examine whether     BAT activity is increased after a meal.   "
100187|NCT01974765|"     This is a Phase II study. The purpose of this study is to find out what effects, good and/or     bad enzalutamide has on the patient and the cancer. All patients who enter the study will be     closely monitored for side-effects. If multiple patients develop significant side effects     from enzalutamide, the study may be stopped early.      Enzalutamide is an androgen-receptor inhibitor, which means that it blocks the activity of     the hormone testosterone. In ovarian, fallopian tube, and primary peritoneal cancers that     express the androgen receptor, blocking the androgen-receptor may possibly slow or stop tumor     growth. Enzalutamide has been studied in women with breast cancer, but this is the first     study using enzalutamide for the treatment of patients with ovarian, primary peritoneal, or     fallopian tube cancer.   "
100188|NCT01974752|"     Selumetinib therapy in patients with metastatic uveal melanoma.   "
100189|NCT01974739|"     Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce     hypernatremia and shorten the time of hypernatremia, we investigate the effect of     hydrochloorthiazide compared to a placebo   "
100216|NCT01974388|"     Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by     both restrictive and hormonal action.      Consecutive patients with morbid obesity treated by LSG at our department were evaluated.     Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from     the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome     measure was the % of excess weight loss (%EWL); secondary outcomes included operative time,     day to resume oral feeding, postoperative morbidity and mortality, improvement of     comorbidity.   "
100221|NCT01974323|"     This study will assess the safety and efficacy of dapsone gel versus vehicle control in     patients with acne vulgaris.   "
100190|NCT01974726|"     The aim of this study is to determine which of the many Eustachian tube function tests (or     combination of tests) is most helpful in finding out what is causing ear problems in children     and adult patients with middle-ear diseases thought to be due to poor Eustachian tube     function. The Eustachian tube is a biological tube that connects the middle ear to the back     of the nose and throat. When the Eustachian tube works normally, it opens and closes to help     keep the pressure in the middle ear the same as room air-pressure (atmospheric pressure).     When the Eustachian tube does not work well, the pressure in the middle ear can increase or     decrease and feel like a blocked ear or cause ear pain. Poor Eustachian tube function can be     associated with distressing middle-ear symptoms, predispose to middle-ear problems under     conditions of rapidly changing air pressures such as occur during airflight and diving, and     cause certain middle-ear diseases such as otitis media with effusion. It is also known that     the results for the most commonly used Eustachian tube function tests in adults and children     with various middle-ear diseases are poorer when compared to children and adults without     middle-ear diseases. However, knowing that there is a difference in test results between     groups with and without disease does not mean that any of those tests provide information     useful in the management of individual patients with diseases due to Eustachian tube     function. To be useful clinically, a test(s) that can accurately identify patients with a     level of poor Eustachian tube function sufficient to cause middle-ear symptoms and signs     and/or cause middle-ear disease is needed. To be very useful, tests should be able to     diagnose the cause of any observed Eustachian tube problem so that treatment for that problem     could be begun. The investigators would also want tests that could predict whether or not the     ear disease will resolve with (or without) treatment and whether or not certain surgical     procedures for middle-ear problems will be successful. Here, a number of Eustachian tube     function tests are being used to diagnose and characterize the cause of Eustachian tube     dysfunction in children and adults presenting to the research clinic with suspected poor     Eustachian tube function and/or a recent history of middle-ear disease that can be caused by     poor Eustachian tube function. After the testing, medical records will be periodically     reviewed for 2 years and study participants will be contacted by phone to obtain information     on their middle-ear disease, the response of the disease to any treatments and the     success/failure of any surgical procedures used to fix middle-ear problems.      Because this study focuses on evaluating the potential usefulness of Eustachian tube function     testing for the diagnosis of Eustachian tube dysfunction and, if present, its cause, no     specific treatments or surgical interventions are included in this study or recommended by     the investigators. These decisions are left to the subject-patient in consultation with their     doctor.      To further evaluate the Eustachian function tests, a control group of healthy adults without     a history of middle-ear problems will undergo testing at two separate sessions; these     subjects will have no further follow-up.   "
100192|NCT01974700|"     Seizures are a potential complication of surgical repair of intracranial aneurysms. In order     to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during     the intra-operative and post-operative period, however, such practice is not supported by     clinical data. Retrospective review found the incidence of postoperative seizures was higher     in those who received anti-epileptics versus those who did not. The goal is to examine the     utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical     repair of unruptured intracranial aneurysms.   "
100193|NCT01974687|"     This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of     uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with HCV     genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The     antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.   "
100194|NCT01974674|"     It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic     islet transplantation for the treatment of type 1 diabetes.      19 patients with type 1 diabetes will be included and ideally distributed evenly: patients     with unstable diabetes without renal insufficiency (AI group for islet alone by the     international customary determination) and patients with a functioning kidney transplant (IAK     group for islet after kidney). The main endpoint will be defined by the restoration of     normal glycemic control without insulin at 6 months after graft.   "
100195|NCT01974661|"     The primary objective of this study is to answer the question Is it possible to inject the     COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects?   "
100196|NCT01974648|"     The aims of this study were to determine the clinically required concentration of propofol     for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of     propofol and improves conditions for it's insertion.   "
100197|NCT01974635|"     In this study, an FDA-cleared device and type of treatment called AMES, which stands for     Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the     upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or     stroke improves along with movement through treatment. We hypothesize that measureable     improvement in the sensation of the upper limb will precede improvement in functional     movement.   "
100198|NCT01974622|"     The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related     macular degeneration, which is essentially choroidal neovascularization for permeability and     vascular proliferation for the retinal circulation, to treat another permeable abnormality -     retinal capillary abnormalities - located eccentric to the central portion of the macula or     in the foveal region.   "
100200|NCT01974596|"     The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri     Prodentis upon the peri-implant health of edentulous patients with dental implants and     peri-implant mucositis, establishing comparisons versus implants without peri-implant     disease. The hypothesis of the study is that using these probiotics are going to improve the     periimplant health.   "
100201|NCT01974583|"     Split-thickness skin grafting remains fundamental treatment of patients with deep burns and     other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing     has been controversial until now. Our study here aimed to assess patient comfort and     wound-healing efficacy with the application of thin split-thickness grafting on STSG donor     sites.   "
100202|NCT01974570|"     Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases.     Epidemiological studies show that there is a direct relationship between blood pressure and     CVD, and cardiovascular mortality increases progressively throughout the range of blood     pressure, including the prehypertensive range. There is also evidence from cell and animal     studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other     marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide     concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.   "
100203|NCT01974557|"     Primary: To observe how hemodynamic parameters are affected by age during rest and exercise     in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.      Secondary: To thoroughly examine this population with regard to cardiac performance and     function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary     status, and humoral markers of organ functions. This population will serve as a healthy     control group, to which different populations can be compared, hence the need for a     comprehensive characterization.      Hypotheses:      Diastolic function and parameters associated with diastolic function gradually deteriorate     with increasing age. The gradual deterioration is unmasked at an earlier age during exercise     and fluid challenge, compared to measurements made at rest.   "
100204|NCT01974544|"     The obesity and type 2 diabetes mellitus (T2DM) are among the most threatening health crisis     for the 21st century. Currently, it is estimated that there are 205 million people with T2DM     worldwide. Chile has a similar magnitude of problem with the prevalence of diabetes     increasing from 6.3% in 2003 to 9.4% in 2010. T2DM is a complex disease characterized by     hyperglycemia, insulin resistance and a relative β-cell failure. Well-known studies for the     treatment of T2DM (ADVANCE trial) showed that intensive medical treatment significantly     reduces the complication of diabetes. On the other hand, less than 40% of patients with T2DM     achieve a metabolic control of diabetes, despite medical treatment. Recently, bariatric     surgery has emerged as an effective treatment for T2DM. Data from different sources has shown     that Roux-en-Y Gastric Bypass (RYGB) can place T2DM into remission. More recently, Sleeve     Gastrectomy (SG) has been shown to also impact metabolically and hence also emerged as an     attractive T2DM-controlling bariatric procedure with fewer complications than RYGB. Recently,     the International Federation for Diabetes has supported the use gastrointestinal surgery     initially developed for morbid obesity as an option to treat patients with diabetes. In the     current proposal the investigators aim to address several issues concerning metabolic surgery     and the ability of the most common bariatric procedures performed to control diabetes. The     investigators are proposing a prospective randomized trial comparing RYGB, SG and the best     medical treatment availed for the T2DM in poorly control patients with the primary endpoint     being 36 month glycemic control (patients achieving HbA1C < 6.5%, normal glucose levels not     requiring medication). The main working hypothesis is that RYGB and SG achieves better     glycemic control than the best treatment availed for the T2DM based on more effective     mechanisms to enhance insulin secretion, insulin sensitivity, lipid metabolism and blood     pressure control. The goals are, 1) Is gastric bypass surgery and sleeve gastrectomy safe for     the microvascular complications of T2DM?; 2) Can gastric bypass, sleeve gastrectomy surgery     and intensive non surgical treatment reverse or reduce the progression of microvascular     complications of T2DM?; and 3) Can gastric bypass and sleeve gastrectomy realize a return on     investment within 2 years in patients with type 2 diabetes who are at risk of developing or     deteriorating microvascular complications?   "
100205|NCT01974531|"     The purpose of the present prospective study is the analysis of risk and protective factors     of perinatal stress and psychological distress of parents with or without a preterm child.     Stress is measured biologically by Cortisol levels and psychologically by a questionnaire.     Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress     disorder, burnout) are measured by various questionnaires. We analyze the influence of     different aspects as personality traits, social support, partnership.   "
100206|NCT01974518|"     The purpose of this study is to compare the effectiveness of rituximab alone vs combination     of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to     routine medications.   "
100207|NCT01974505|"     Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal     intubation. This study will investigate learning curve of Optiscope by anesthesia providers.   "
100208|NCT01974492|"     In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts     that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation     that remodeling of saphenous vein graft differs between those harvested from upper leg vein     and lower leg, this study aims to compare histologic and immunohistochemical findings between     saphenous vein grafts harvested from upper leg and lower leg.   "
102775|NCT01940913|"     To assess the tolerability and effect of a probiotic product, when co-administered with     antibiotics, on the incidence and duration of loose/watery stools following the antibiotic     treatment in children.   "
100209|NCT01974479|"     Modern therapy for patients with B-lineage acute lymphoblastic leukemia (ALL) is based on     intensive administration of multiple drugs. In patients with relapsed disease, treatment     response is generally poor; for most patients, particularly those who relapse while still     receiving frontline therapy, the only therapeutic option is hematopoietic stem cell     transplantation (HSCT). There is no proven curative therapy for patients who relapse after     transplant.      Natural killer (NK) cells have powerful anti-leukemia activity. In patients undergoing     allogeneic HSCT, several studies have demonstrated NK-mediated anti-leukemic activity. NK     cell infusions in patients with leukemia have been shown to be well tolerated and void of     graft-versus-host disease (GVHD) effects.      NK cell cytotoxicity is most powerful against acute myeloid leukemia (AML) cells, whereas     their capacity to lyse ALL cells is generally low. We have developed a novel method to expand     and redirect NK cells towards CD19, a molecule highly expressed on the surface of B-lineage     ALL cells but not expressed on normal cells other than B-lymphocytes. In this method, donor     NK cells are first expanded by co-culture with the cell line K562-mb15-41BBL and interleukin     (IL)-2. Then, the expanded NK cells are transduced with a signaling receptor that binds to     CD19 (anti-CD19-BB-zeta). NK cells expressing these receptors showed powerful anti-leukemic     activity against CD19+ ALL cells in vitro and in an animal model of leukemia.      This study will assess the feasibility, safety and efficacy of infusing expanded, activated     redirected NK cells into research participants with B-lineage ALL who have persistent disease     after intensive chemotherapy . In this same cohort, we will study the in vivo lifespan and     phenotype of these redirected NK cells.   "
100210|NCT01974466|"     To compare different goals of fluid resuscitation in early stage of acute pancreatitis   "
100211|NCT01974453|"     Radiation issue during percutaneous coronary interventions is an important issue for     operators due to the long term stochastic risk of cancer induction, but is often     under-evaluated. Many factors may be associated with the radiation dose adsorbed by     operators. In particular the most important are the position taken by the operator, the use     of dedicated X-ray shield and the duration of the procedure. However other factors (as     operator height or the angulation of the radiation tube) might have some important effects     but are often under-evaluated .      Aim of our observational study is to evaluate the most important determinants of the     radiation dose adsorbed by operators during different coronary procedures (diagnostic     coronary angiography or percutaneous coronary interventions) and through different vascular     accesses (right or left transradial approach or transfemoral approach).      All patients who underwent to percutaneous coronary diagnostic or interventional procedures     will be enrolled in this observational study.      Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax     level outside the lead apron and at head level to evaluate the radiation dose at crystalline.     Effective doses delivered to patients will be expressed as dose area product (DAP) and     measured in Gycm2.   "
100212|NCT01974440|"     The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib)     administered in combination with either bendamustine and rituximab (BR) or rituximab,     cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants     with previously treated indolent Non-Hodgkin lymphoma.   "
100213|NCT01974427|"     Objective:      The goal of this protocol is to improve understanding scale-free brain activity and conscious     vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging     and brain stimulation pilot substudies. This research is expected to help develop techniques     and hypotheses for future research on these topics.      We will conduct:        -  Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough          information to generate a hypothesis. The criterion for transition to a new full          protocol will be acquisition of sufficient information to generate a power analysis.          There are no enrollment limitations for pilot substudies.        -  Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be          tested that can be completed with a few healthy volunteers or patients.          Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6 subjects          (if there is one group) or after 12 (6 per arm) if two groups are studied before          additional subjects are recruited. In the event of subject dropout or unsuccessful          recording, replacement will be recruited. Together, the P.I. and PIRC will decide          whether to continue the hypothesis substudy with more subjects without an amendment or          whether an amendment or new protocol would be necessary. A memo requesting a review of          hypothesis-testing substudies for possible additional enrollment will be sent to PIRC          and the statistical reviewer. The memo will be forwarded to the CNS IRB.        -  Technical development of new experimental paradigms and data analysis methods.      This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG,     tDCS).      Study Population:      We plan to recruit up to 120 healthy volunteers aged 18-65.      Design:      We will design small projects that are pertinent to the theme of scale-free brain activity     and conscious/unconscious processing. We will investigate healthy volunteers in the resting     state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy     leads to results of interest and if a larger population is necessary to reach statistical     significance, a separate protocol will be submitted with a priori hypotheses, specific study     design and power analysis adapted from the pilot or exploratory substudies performed in the     present protocol.      In the substudies, brain activity of healthy human volunteers will be monitored by functional     magnetic resonance imaging (fMRI), magnetoencephalography (MEG), electroencephalography     (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in some subjects to allow     better localization of brain dynamics. Because transcranial direct-current stimulation (tDCS)     is ideally suited to modulate the slow component of scale-free brain activity, we will also     investigate the effect of tDCS on brain activity and/or behavioral performance in cognitive     tasks. tDCS will be administered sequentially, but not simultaneously, with brain-activity     monitoring by fMRI/MEG/EEG. Most experiments will be conducted in conjunction with cognitive     tasks. In some experiments, we will study resting-state brain function, during which     spontaneous brain activity is collected without a specific externally administered task.      Outcome Measures:      MRI: to analyze measures such as the anatomical structures of the brain (using structural     MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI); cerebral     blood flow [using arterial spin labeling (ASL)] and different neurotransmitter levels in     brain regions of interest [using magnetic resonance spectroscopy (MRS)].      EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials,     synchronization/desynchronization, and coherence between sensors or sources located close to     the brain areas of interest.      tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS.      Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography     (EMG) patterns.      We may measure autonomic data during the course of the experiment (such as heart rate,     respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome     measures.   "
100214|NCT01974414|"     The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic     oral lichen planus ( a common oral problem).   "
100222|NCT01974310|"     Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated     by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole     surgery, face-down positioning is often advised with the aim of improving the likelihood of     macular hole closure. The current evidence of postoperative positioning protocols is     insufficient to draw firm conclusions and guide practice. The investigators wish to compare     non-face-down positioning and face-down positioning after surgery for macular holes in a     randomized trial.      Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery     for macular holes.   "
104190|NCT01922349|"     Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in     healthy Chinese, Japanese and Caucasian male volunteers.   "
100227|NCT01974245|"     Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially     in those undergoing dialysis. The loss of protein to the dialysis solution seems to     contribute significantly to the reduced serum levels of vitamin D in these patients. As a     result of the disease and the dialysis procedure, there is high prevalence of chronic     inflammation and high risk of infections. There is evidence in other populations, that     vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an     antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus, this     study aims to investigate the effects of cholecalciferol supplementation on immunological     markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis D . This is     a randomized, double-blind, placebo-controlled trial in which patients who have vitamin D     deficiency [25 (OH) D <20 ng / mL] will be allocated to the intervention group     (cholecalciferol) or control (placebo). Patients will receive supplemented 100,000 IU / week     cholecalciferol a period of 12 weeks. Before and after the intervention will be determined     25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive     protein serum. In monocytes, we will evaluate cathelicidin, IL-6 and TNF-α, 25(OH)D receptor     and α 1-hydroxylase enzyme expression.   "
100228|NCT01974232|"     This is a retrospective analysis of children (≤21years old) who received clinical treatment     with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children     included in this study were from Weill Medical College of Cornell University, New York, New     York and Children's Hospital Orange County, Orange, California   "
100229|NCT01974219|"     In cigarette smokers that are HIV+, one of the most common HIV-associated non-AIDS conditions     is the accelerated development of chronic obstructive pulmonary disease (COPD), a disorder     associated with significant morbidity and mortality. Based on the knowledge that COPD in     smokers starts in the small airway epithelium, this study is focused on examining the     hypothesis that the accelerated development of COPD associated with HIV infection results, in     part, from an interaction of HIV directly on the small airway epithelium or through infection     of cellular components of the immune system, with mediators released by these immune cells     evoking premature biologic aging of the small airway epithelium. By identifying the early     events in the pathogenesis of the HIV-associated accelerated COPD in smokers, we aim to     identify biologic targets to which pharmacologic therapies could be addressed.   "
100230|NCT01974206|"     The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in     reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects     receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of     ASP0113 in this patient population.   "
100231|NCT01974193|"     Pelvic lymph node dissection (PLND) is an important step in the surgical staging and     treatment of gynecologic malignancies.      Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including     chemotherapy and radiation therapy, which potentially affects the success of cancer     treatment.      A number of surgical techniques have developed, but failed to reduce the incidence of pelvic     lymphoceles after PLND.      The investigators hypothesized that floseal can prevent lymphoceles in patients with     gynecologic cancer who has undergone PLND.      The investigators designed prospective randomized controlled study as a pilot study.      The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and     observe the occurence of pelvic lymphoceles after 6 months later.   "
100232|NCT01974180|"     Early changes associated with the development of smoking-induced diseases, e.g., COPD and     lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal     airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells     necessary for generation of differentiated airway epithelium. Based on our preliminary     observations that epidermal growth factor receptor, known to regulate airway epithelial     differentiation, is enriched in BC and its ligand EGF is induced by smoking, we hypothesized     that smoking-induced EGF alters the ability of BC to form normally differentiated airway     epithelium. To test this, airway BC will be purified using a cell-culture method established     in our laboratory and responses to EGF will be analyzed using genome-wide microarrays and an     in vitro air-liquid interface model of airway epithelial differentiation.   "
100233|NCT01974167|"     The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy     compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis,     using a randomized, open-label, parallel-group, comparative design.   "
100234|NCT01974154|"     Cigarette smoking is the major cause of chronic obstructive pulmonary disease (COPD), the 4th     cause of mortality in the US. Central to COPD pathogenesis is ciliopathy, dysfunction of     the airway ciliated cells that mediate transport of mucus to remove inhaled pathogens. The     focus of this study is to carry out metabolic profiling of banked biologic samples and assess     the hypothesis that COPD is associated with a unique metabolome in serum and lung epithelial     lining fluid, and that subsets of the COPD metabolome are linked to the ciliopathy of COPD.   "
100235|NCT01974141|"     This study will assess the safety and efficacy of dapsone gel versus vehicle control in     patients with acne vulgaris.   "
100236|NCT01974128|"     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?   "
100259|NCT01973829|"     The purpose of the study is to test whether the health care provider access and training in     CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness), would facilitate     timely and error free best-practice delivery and minimize preventable death and costly     complications in critically ill patients.   "
100237|NCT01974115|"     Extracorporeal shock wave therapy (ESWT) has been successfully introduced into the treatment     of cellulite over the last years. The purpose of this study is to test the following     hypotheses: (i) cellulite can be efficiently and safely treated using the radial     extracorporeal shock wave device, Swiss Dolorclast (Electro Medical Systems S.A., Nyon,     Switzerland); and (ii) the individual clinical outcome of cellulite treatment with ESWT can     be predicted by means of the patient's individual cellulite grade at baseline, the patient's     individual age, body mass index (BMI), weight, and/or height.   "
100238|NCT01974102|"     The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a     pilot sample of parents of toddlers and engaging them in a pilot study to test a version of     mindfulness-based stress reduction (MBSR), an empirically-supported stress-reduction     intervention, plus nutrition and physical activity counseling for parents of preschoolers     (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy     eating and physical activity in parent and child; and prevent overweight and obesity in     preschoolers with an obese parent.   "
100239|NCT01974089|"     To determine the prevalence of dysphagia among Danish patients hospitalized with pneumonia     and to test whether it is possible to reduce the swallowing disorders by changing the     consistence of food and drink. Patients hospitalized in the period from the 1st of September     2013 to the 31st of March 2014 will be tested by an occupational therapist for dysphagia     within the first 24 hours of their hospitalization. The endpoints will be number of     hospitalization days, rehospitalisation and mortality. If the test is positive, the patient     will get a diet of a manageable consistency to avoid dysphagia.   "
100240|NCT01974076|"     This study will investigate whether transcranial direct current stimulation (tDCS) can     enhance the efficacy of cognitive behavioural therapy for the treatment of depression.   "
100241|NCT01974063|"     Cigarette smoking evokes major changes in the biology of the airway epithelium, the cell     population that takes the brunt of the stress of cigarette smoke and the cell population     central to the pathogenesis of chronic obstructive pulmonary disease (COPD) and lung cancer.     The focus of this study is to identify the differences that two popular alternative nicotine     delivery strategies, shisha and electronic cigarettes, have on the airway epithelium compared     to cigarette smoking. We hypothesize that both alternative nicotine delivery strategies     disorder airway epithelial biology, but in different ways than does cigarette smoking.   "
100242|NCT01974050|"     In this study, the investigators will prospectively assess fever rates and other adverse     events in pregnant women after administration of inactivated influenza vaccine (IIV) using     text messaging. The investigators hypothesize that women <20 weeks gestational age who     receive IIV will be willing to enroll in a text messaging-based vaccine adverse event     monitoring program and will use it to report fever in the post-vaccination period as well as     continue to text pregnancy-related outcomes through the end of their pregnancy.   "
100243|NCT01974037|"     Excess dietary salt intake is closely associated with the development of hypertension and     cardiocerebral vascular diseases. Preference of high salt diet might involve salty gustatory     cortices change. This study focuses on examining the neuroimaging changes of salty gustatory     cortices under different concentration of NaCl solution with or without capsaicin     intervention through brain PET/CT scan.   "
100244|NCT01974024|"     The aims of this study were to investigate the feasibility of methylprednisolone rotation as     treatment of DIH.   "
100245|NCT01974011|"     Dorsal penile nerve block (DPNB) is a regional nerve block probably most often performed     throughout the world. There are several different methods described in the literature. When     compared to penile ring wall infiltration or caudal block, the Dorsal penile nerve block     (DPNB) is more likely associated with the risk of failure of the block quality. The aim of     this study is to compare the quality of the standard method of Dorsal penile nerve block     (DPNB)(Dalens' technique) with that of a modified procedure (Dorsal penile nerve block     (DPNB)with additional infiltration of the ventromedial penis at the transition between the     penis and the scrotum.   "
100246|NCT01973998|"     Background: COPD exacerbations add considerably to patients' burden because they: (1) cause     frequent hospital admissions and relapses or readmissions, (2) contribute directly to the     death of many patients, either during hospitalization or shortly thereafter, (3) cause     patients significant stress, prolonged physical discomfort, disability and dramatically     reduced quality of life, (4) consume the majority of the resources available to manage this     chronic condition, (5) frequently progress to a severe stage warranting hospitalization     before any abortive treatment is instituted, and (6) may hasten the progressive loss of lung     function, a steady decline that is a cardinal feature of COPD itself. Hence, investigations     of new therapies to treat COPD patients who are hospitalized with a severe exacerbation are     desperately needed.      Objective: To test the feasibility of roflumilast to decrease all cause readmission and     mortality 180 days after hospitalization for acute COPD exacerbation.      Methods: Parallel-group, prospective, randomized, double blind, placebo-controlled trial of     roflumilast 500 ug daily vs. placebo in approximately 100 hospitalized AECOPD patients.     Inclusion Criteria. Primary diagnosis of AECOPD; admission to the hospital <12 hours; patient     age >40, < 80 years old; cigarette smoking > 10 pack-years. Exclusion Criteria. Prior     diagnosis or high suspicion for asthma; pulmonary edema, pneumonia, interstitial lung disease     or significant bronchiectasis; intubated and mechanically ventilated at the time of     evaluation; active liver disease, or transaminase elevations (> 3xULN); history of heavy     ethanol use; history of suicidal behavior ≤ 2 years or suicidal ideation ≤ 6 months prior to     enrollment; pregnant or lactating females. Those on the following excluded medications: P450     inducers and CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2     simultaneously   "
100260|NCT01973816|"     The purpose of this study is to determine whether, in women with deep endometriosis involving     the rectum and not intending to get pregnant, continuous hormonal treatment would be followed     by better digestive functional outcomes than curative rectal surgery. Are included women from     35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of     the rectum and not having pregnancy intention.      The main outcome concerns the quality of digestive function 24 after the onset of the     treatment, assessed using a composite variable: patient considering that digestive function     is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the     Gastrointestinal Quality of Life Index (GIQLI) score >100.      Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel     movements, anal incontinence, postoperative dysuria, Biberoglou & Behrman score, quality of     life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score,     the rate of postoperative complications, medical treatment adverse outcomes, the rate of     additional endoscopic and surgical procedures.      The randomization is central, once the physician asses the diagnosis, explain the study's     principle and rece In the arm A, the patients received triptoreline and add back therapy by     estradiol during 6 months, followed by daily intake of cyproterone acetate and add back     therapy during 18 months.      In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal     shaving, rectal disc excision or colorectal resection) followed by the prevention of     recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.      The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24     months. The length of the follow up is 24 months. The patients have 8 visits in the arm A,     and 7 visits in the arm B.      Eleven French tertiary referral centres will enrol patients in the trial.   "
100247|NCT01973985|"     Pleural effusion is an extremely common problem with multiple causes; its subsequent     investigation with thoracocentesis and treatment with drainage represent two of the most     frequently performed diagnostic and therapeutic medical procedures. The role of thoracic     ultrasonography in the management of pleural effusion is a modern and rapidly expanding one,     having become effectively mandatory and part of the gold standard over the past decade due     to its diagnostic and patient safety benefits. By contrast, the measurement of intra-pleural     pressure using sequential manometry has failed to convincingly demonstrate its clinical value     beyond physiological studies despite its availability for over a century. Previous work has     shown a potential role for pleural manometry in predicting the presence of un-expandable lung     and success of talc pleurodesis but these studies have not been replicated or clinically     validated.      We intend to combine the old and new in an observational study comparing findings on thoracic     ultrasonography and pleural manometry during thoracocentesis with patient-reported symptoms     and the key clinical outcomes of presence of un-expandable lung and success of talc     pleurodesis. The investigators hypothesise that the previously described variations in     pleural elastance can be correlated with appearances and anatomical changes visualised on     thoracic ultrasonography; and in combination can be reliably utilised to predict clinical     outcome. The study may allow the proposal of a treatment algorithm that allows patients with     pleural effusion to be managed in a more expeditious and efficient manner.   "
100248|NCT01973972|"     The proposed research will test a novel program that combines intensive weight management     with shared (group) medical appointments for patients with diabetes. This research is     important because diabetes is increasingly prevalent, it requires complex management by the     provider and the patient, and weight loss is a critical component of its management. Adding     weight management to shared medical appointments could potentially improve blood sugar     control while reducing medications and their side effects such as low blood sugar.   "
100411|NCT01971840|"     Coordinated project whose objectives are: a) to assess the effectiveness of a physical     activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the     adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the     carotid intima-media thickness.   "
100249|NCT01973959|"     Anaesthesiology plays a key role in promoting safe perioperative care. This includes the     perioperative phase in the post-anaesthesia care unit (PACU) where problems with incomplete     information transfer may have a negative impact on patient safety and can lead to patient     harm. The objective of this study is to analyse information transfer during postoperative     handovers in the PACU.      With a self-developed checklist information transfer during postoperative handovers will be     documented and subsequently compared with patient information in anaesthesia records.   "
100250|NCT01973946|"     The purpose of this prospective trial is to test a daily telephone based automated symptom     monitoring and response system to track and further treat unrelieved symptoms for patients     living at home during chemotherapy treatment as compared with usual care which consists of     patients calling their oncology provider for symptom concerns.   "
100251|NCT01973933|"     This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of     pyrimethamine and metformin IR after oral administration in healthy male volunteers.   "
100252|NCT01973920|"     Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism     caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current     methods of insulin therapy for diabetic patients are multiple daily injection therapy and     continuous subcutaneous insulin infusion with an external pump. This rout of administration     may lead to hyperinsulinemia as insulin is administered in a non physiological way, targeting     mainly extra hepatic tissues (muscle, fat). A method of providing insulin without the need     for injections has been a goal in drug delivery.      Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on biochemistry     and quantum theory of biochemical reactions. The carrier enables the absorption of proteins     from the gastrointestinal tract in their full structure. Oshadi has also developed the Oshadi     Icp - insulin, proinsulin and C-peptide in Oshadi carrier, administrated orally. This study     was design in order to evaluate the safety and feasibility of multiple administrations of     Oshadi Icp for home use. The study will be a multiple-dose, open-label non-randomized study     in patients with Type 1 diabetes, with periodic dose adjustments. The study will include 4     weeks of multiple-dose administration of Oshadi oral insulin (Oshadi Icp) at home and in     study center for the determination of the efficacy, safety and pharmacodynamic effects of     Oshadi Icp.   "
100253|NCT01973907|"     The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results     in the best outcomes for children treated for suspected or confirmed septic shock. In this     study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid     Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock     Resuscitation Guidelines, with the assigned resuscitation strategy used to guide     administration of further fluid boluses as well as the timing of initiation and escalation of     vasoactive medications to achieve ACCM recommended hemodynamic targets.   "
100254|NCT01973894|"     This study investigates what independent variables may influence Midazolam Pharmacokinetics     in critically ill patients.   "
100255|NCT01973881|"     This study is for the development and validation of functional magnetic resonance imaging     (MRI) parameters as biomarkers for analyzing extent of disease and quantifying response to     treatment in patients with myelofibrosis.   "
100256|NCT01973868|"     To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in     combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose     (RP2D)   "
100257|NCT01973855|"     To meet eligibility criteria, this study and informed consent of the syndrome of fever     associated with bleeding of infectious diseases, severe patients to carry out multicenter,     practical randomized controlled clinical research, to compare the curative effect of western     medicine, combining Chinese and western medicine treatment, and security, and pathogenesis of     TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese     medicine, Chinese medicine prescriptions mechanism research.   "
100258|NCT01973842|"     The present study aims to investigate whether the dosage of the GnRH agonist used for     triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk     for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and     recombinant FSH.   "
100261|NCT01973803|"     This study is to evaluate the performance of the Articulinx ICMC     (InterCarpoMetacarpalCushion) in the carpometacarpal joint (CMC joint) and to describe the     clinical results in patients who have been treated with this device. Expected results include     the relief of symptoms and improvement of function in patients with symptomatic     osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved     through measurements of pain, pain medication use, and joint function in up to 40 subjects.     Each subject will be compared to their pre-surgery status for each endpoint.   "
100262|NCT01973790|"     The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID     in European subjects with FD.   "
100263|NCT01973777|"     The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device     consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and     bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial     pilot of 15 women, there were no complications during the 12 months. This observational pilot     study of 50 women will determine that the early expulsion rate is not greater than 10% and     that there is patient and physician acceptance, so that we can plan a larger randomized     controlled trial for efficacy and safety.   "
100264|NCT01973764|"     Puncture of the ventricular system is one of the most frequently performed neurosurgical     interventions. This procedure is commonly performed in order to treat and/or measure     pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is     needed. Currently the landmark-based placement of intraventricular catheters is the gold     standard. However it is known that more than 60% of the catheters are not accurately placed     in accordance with landmark-based procedures. When the catheter is not placed accurately     multiple punctures may be required. In this study, the investigators aim to investigate     prospectively whether ultrasound guidance leads to a lower number of incorrect catheter     placements, and whether this guidance consequently decreases the number of punctures.   "
100265|NCT01973751|"     Novel asthma biomarkers to predict the response to inhaled corticosteroid Brief description:     This will be a single center study of asthmatic subjects and healthy controls which will     investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay     of asthma therapy. Only about half of the asthmatic patients have improved lung function     after treatment of inhaled corticosteroid. The investigators hypothesize that there are     biomarkers such as epithelial cytokines (IL-25, IL-33, TSLP) in airway tissues or plasma of     asthmatic patients which could predict the response of asthmatic patients to inhaled     corticosteroid. Finding novel asthma biomarker will help the clinicians to choose the optimal     treatment for individual asthmatic patient.   "
100266|NCT01973738|"     Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene     (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to     compare clinical efficacy and safety between RLX and BZA.   "
100267|NCT01973725|"     Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic     Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.   "
100268|NCT01973712|"     A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of     fracture is often difficult to fix because of the close proximity of the two surgical     implants which can sometimes interfere with proper bone healing. Improper healing can cause     significant impairment and sometimes requires additional surgeries to correct the problem.     Despite considerable interest and research put into developing techniques to repair this     fracture surgeons do not know which is the best way to treat this type of fracture.      Our multicentre orthopaedic study group is conducting this study to compare two standard, but     different treatments for periprosthetic distal femur fractures. One treatment consists of     open surgery and the placement of a plate and screws along the side of the femur. The other     consists of implanting an intramedullary nail in the femur.      The goal of this study is to directly compare the two treatments to see if one treatment     results in better patient outcomes than the other.   "
100269|NCT01973699|"     Adequate visualization during shoulder arthroscopy is of great importance for the procedure     to be efficiently and effectively performed. The use of dilute epinephrine in irrigation     fluid has been historically utilized to help with visualization. Given the potential safety     issues documented in the literature related to epinephrine use, as well as the significant     improvements in technique and instrumentation over the last decade, the need for this     additive should be reexamined. The objective of the current study was to compare surgeon     determined visualization in shoulder arthroscopy using irrigation fluid with and without     epinephrine.   "
100270|NCT01973686|"     The aim of the present study is to investigate the changes in body composition and the degree     of compensation to exercise induced energy expenditure after 1 year of physical activity with     either moderate or vigorous intensity in overweight and class 1 obese men and women. The     present study is a sub study to main study Active Commuting To Improve Well-being and Health     in Everyday Life (NCT 01962259)   "
100271|NCT01973673|"     Prostate cancer patients receiving hormone treatment (androgen deprivation therapy, or ADT)     are at increased risk of developing bone loss and osteoporosis as side effects. To prevent     this, guidelines recommend participation in healthy bone behaviours including weight-bearing     exercise and adequate calcium/vitamin D intake. However, prior studies have shown that     patients are not regularly screened or counselled regarding healthy bone behaviours while     receiving ADT. Maintaining bone health in prostate cancer patients is important because men     on ADT are at increased risk of fractures. In this study, the investigators will examine     whether an intervention designed to improve healthy bone behaviours among prostate cancer     patients on ADT can be implemented. The intervention consists of a written healthy bones     prescription, brief verbal counseling, and printed educational materials for participants.     Investigators hope to obtain an initial estimate of whether the intervention works. They also     hope to show that this simple intervention can be implemented in a real, working cancer     clinic.      The investigators hypothesize that an intervention to improve bone health in prostate cancer     patients receiving ADT (healthy bones prescription, verbal counseling, and printed     educational materials) is effective, implementable, and accepted by clinicians and patients.   "
100307|NCT01973192|"     The purpose of this study is to test the hypothesis that early viral infections alter the     bacterial flora and inflammatory profile in the airway and accelerate progression of     pulmonary disease in infants with cystic fibrosis.   "
100272|NCT01973660|"     Non-randomized, open label, multicentric translational research study in women with untreated     invasive breast carcinoma eligible for primary surgery (Stage I-IIIA).      The aim of PAMELA is to test the hypothesis that PAM50 HER2-enriched (HER2-E) subtype better     predicts response to neoadjuvant dual anti-HER2 blockade, with or without endocrine therapy,     compared to traditional clinical HER2 classification. Furthermore, we posit that     characterization of gene expression patterns may identify profiles of those who may be safely     spared chemotherapy.   "
100322|NCT01972997|"     This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on     the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4     24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor     lens sizes is placed on the eye in the different sessions. Subjects visit the study site for     installation and removal of the device and accompanying exams, but remain ambulatory during     the recording.   "
100273|NCT01973647|"     Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in     people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality,     with four times the risk of mortality for sleep times < 300 minutes. Insomnia is also related     to greater morbidity, with 75% greater health care costs than people without insomnia.     However, insomnia medications are used with caution in COPD due to potential adverse effects.     Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also     affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy     for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related     beliefs and behavior, is effective for people with primary insomnia and people with other     chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in     people with both insomnia and COPD. The objective in this application is to rigorously test     efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in     people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy     outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting     effects on objectively and subjectively measured insomnia and fatigue. The rationale for the     proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new     and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading     to longer, higher quality and more productive lives for people with COPD, and reduced     societal cost due to the effects of insomnia. The investigators plan to test our central     hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD,     non-sleep health education attention control (AC) using a highly efficient 4-group design.     Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm     3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific     Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on     insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and     COPD-ED. The research proposed in this application is innovative because it represents a new     and substantive departure from the usual insomnia therapy, namely by testing traditional     CBT-I with education to enhance outcomes.   "
100274|NCT01973634|"     Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer     halves the recurrence risk and reduces the breast cancer death by about one sixth. A     sequential boost (SeqB) dose to the tumour bed further improves local control, but also     increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital     WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation     scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the     overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI,     the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time     which is convenient for the patient and the radiotherapy department. In this study we wish to     test the hypothesis of acceptable skin toxicity and reduced cost with SIB using     hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose     painting, a technique recently developed in our group. Patients are randomized between SeqB     and SIB.   "
100275|NCT01973608|"     This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to     assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445     given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma     in combination with stereotactic body radiation therapy (SBRT).   "
100276|NCT01973595|"     The purpose of this study is to determine whether incorporating almonds into the diets of     families with young children will induce beneficial changes in gastrointestinal function, the     fecal microbiota profile, and immune and inflammatory processes of the adults and children     resulting in improved quality of life. The investigators anticipate finding an increase in     beneficial bacteria, improved intestinal function, and decreased inflammation during the     almond intervention.   "
100277|NCT01973582|"     Taiwan has launched a successful nationwide neonatal hepatitis B immunization since July 1,     1984. It successfully decreased the incidence of hepatitis B virus infection, the hepatitis B     carrier rate as well as liver diseases among children and adolescents. The sexual     transmission route is another important way of hepatitis B infection aside from the mother     and child vertical infection, especially for youth and adults. Hepatitis B vaccination cohort     refers to those who were born after 1986 and received hepatitis B vaccine immunization during     newborn period. They are gradually entering into young adults and adolescent age. Among them,     there is no empirical evidence to show the actual infection rate and to help implement     hepatitis B vaccine booster policy for those who had three seronegative viral markers of     hepatitis B. Therefore, the study design is to collect three consecutive years graduate     school students school entry health examination data and undergo three hepatitis B viral     markers checkup and blood types. The data linkage includes their health checkup data in the     freshmen period, Taiwan CDC databank for neonatal hepatitis B immunization records, pregnancy     and birth record registry, Taiwan cancer registry and Taiwan death record registry.   "
100278|NCT01973569|"     To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction     by AMG 162 administered subcutaneously to rheumatoid arthritis patients   "
100279|NCT01973556|"     Patients managed by a newly formed pharmacist-physician medication therapy management team in     a university primary care clinic will have better blood pressure control than patients     receiving usual care.   "
100280|NCT01973543|"     Safety study of AADC gene transfer (VY-AADC01) in subjects with Parkinson's disease.   "
100281|NCT01973530|"     We hypothesize continuous adductor canal block with steroid adjuvant would offer no inferior     analgesics and rehabilitation ability than continuous femoral nerve block for postoperative     patients receiving total knee arthroplasty.   "
100282|NCT01973517|"     Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide     nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this     project we hypothesize that Feraheme could become a sensitive and specific marker of active     inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra     high field strength (7T) MRI to further increase the effectiveness of the contrast agent     Feraheme at revealing inflammatory activity.   "
100283|NCT01973504|"     MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at     risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to     improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate     safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients     suffering from lactic acidosis due to severe hemorrhagic shock.   "
100284|NCT01973491|"     This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to     evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing     multiple sclerosis (MS) and to assess the maintenance of any such effects.   "
100412|NCT01971827|"     Coordinated project whose objectives are: a) to test the effectiveness of a promotion of     physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the     academic performance in both children with and without attention deficit hyperactivity     disorder (ADHD)   "
100285|NCT01973478|"     Major depressive disorders are real public health issues in terms of diagnosis and treatment.     Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide     risk is important.      Patients with TRD are potential candidates for neurosurgical interventions to treat     depression. However, psychosurgery interventions based upon lesions, showed their limitations     related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of     course 3. the irreversible damage caused by the surgery.      Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from     TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed     encouraging results. The investigators have thus planned a randomized controlled trial versus     sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.   "
100286|NCT01973465|"     This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for     CDI. The weight of the evidence in the literature suggests that FMT is the most effective     treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy.      The anticipated benefits to research patients enrolled in this study include resolution of     chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of     chronic recurrent CDI.      FMT involves the endoscopic instillation of freshly obtained stool with millions of live     bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure,     there is a risk of perforated viscous. This is very rare, but the risk is increased with     severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears     to be negligible.   "
100287|NCT01973452|"     The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex),     can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of     opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food &     Drug Administration) for use as a sedative in hospitals and is currently used in the     investigators Intensive Care Unit for this purpose. The investigators want to investigate if     it also has pain relieving properties.   "
100288|NCT01973439|"     To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir     in HIV-1-infected infants and children aged 3 months to 36 months      The secondary objectives of PENTA15 were:      To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in     HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine     in combination with abacavir      To compare age-related differences in the PK parameters of q24h versus q12h dosing of     abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24     months and ≥24 to <36 months)      To describe child and family acceptability of and adherence to q24h compared to q12h dosage     regimens of abacavir and lamivudine   "
100289|NCT01973426|"     We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can     effectively facilitate the ability of participants to perform a specific set of clinically     relevant tasks conducted in a clinic setting.   "
100290|NCT01973413|"     The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced     control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp     setting will allow us to obtain pilot efficacy data.   "
100291|NCT01973400|"     Given that the tocotrienols have been shown to possess neuroprotective effects and that both     type 1 and type 2 diabetes can lead to peripheral neuropathy and cognitive impairment, the     present study aims to determine the beneficial effects of tocotrienols in ameliorating such     neurological related events in both type 1 and type 2 diabetic patients.   "
100292|NCT01973387|"     The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus     rituximab in adult Asia Pacific region patients with relapsed or refractory chronic     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).   "
100293|NCT01973374|"     Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to     adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can     be minimized with tight glucose control. A number of studies in non-pregnant populations have     highlighted the feasibility, acceptability and efficacy of text messaging interventions for     improving diabetic compliance and control. This study will investigate whether a text     messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and     whether this intervention can improve compliance with diabetes care, glucose control and     pregnancy outcomes. The study will also assess satisfaction with the intervention itself.   "
100294|NCT01973361|"     The UltraHeal Study is a randomized controlled trial to compare healing response of low     frequency contact ultrasonic-assisted debridement in addition to best practice wound care to     best practice wound care alone in a Vascular Surgery Clinic patient population with wounds of     the lower extremity.   "
100308|NCT01973179|"     The goal of this observational study is to evaluate the toxicity and local tumor control of     proton therapy for patients with head and neck cancer in a previously irradiated field.      Standard of care for recurrent or secondary malignancies in a previously irradiated field is     surgery. For inoperable patients or residual tumor after surgery, standard of care would be     palliative chemotherapy. For a small subset of patients (good performance status, small     radiation fields) re-irradiation can be performed. In this study the established concept of     re-irradiation with photons will be transferred to proton radiotherapy. Proton therapy has     the advantage of a steeper dose gradient to normal tissues, thus-theoretical advantages for     lower toxicity.   "
100295|NCT01973348|"     Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia,     which intermittently become opaque and provide effective occlusion for 50% of the time they     are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the     amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized     clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.      Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as     traditional patching treatment.      The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the     standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the     standard 6-hour patching treatment.      This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM     glasses, in treating amblyopia.      Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the     amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses     treatment group and standard 2-hour patching control group.      Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the     amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses     treatment group and standard 6-hour patching control group.   "
100296|NCT01973335|"     This study has two primary objectives:        1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus          high-dose loop diuretics (standard of care) in patients with acute decompensated heart          failure at high risk for diuretic resistance.        2. To demonstrate the safety and efficacy of upfront therapy with spironolactone in          addition to loop diuretic therapy in patients with acute decompensated heart failure at          high risk for diuretic resistance.   "
100297|NCT01973322|"     Title: Vaccination with autologous dendritic cells loaded with autologous tumor lysate or     homogenate combined with immunomodulating radiotherapy and/or preleukapheresis IFN-alfa in     patients with metastatic melanoma: a randomized proof-of-principle phase II study.      Study Design: Randomized selection design, proof of principle study Study Duration: 36 months     Number of Subjects: 24 evaluable patients      Diagnosis and Main Inclusion Criteria: Patients with non resectable stage III or stage IV     malignant melanoma carrying at least 2 measurable lesions, any line after 1st line     Vemurafenib in patients carrying BRAF mutation-positive melanoma and/or ≥ 2nd line     Ipilimumab.      Study Product, Dose, Route, Regimen and duration of administration:      Intradermal Autologous Dendritic Cell vaccine loaded with autologous tumor lysate or     homogenate on weeks 1, 4 6 and 8 during induction phase, and every 4 weeks during maintenance     phase up to a maximum of 14 vaccine doses (each dose followed by IL-2 3 MU day 2-6) COMBINED     OR NOT WITH        -  IFN-alfa 3 MU daily for 7 days before leukapheresis AND/OR        -  Three daily doses of 8 Gy up to 12 Gy delivered to one metastatic field between vaccine          doses 1 and 2 (optional to one additional field between doses 7 and 8) utilizing          IMRT-IMAT techniques.   "
100298|NCT01973309|"     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and     PK of vantictumab when combined with paclitaxel.   "
100299|NCT01973296|"     The purpose of this study is to determine whether a new way of educating/coaching chronically     ill patients discharged from the Emergency Room will help them receive post-ER health care     and strengthen their links to a regular, personal doctor.   "
100300|NCT01973283|"     The goal of this open-administration treatment study of citalopram (or duloxetine) is to     evaluate the effect of antidepressant medication on treating the syndrome of frailty in     older adults with depressive symptoms. Patients with significant depressive symptoms (defined     as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or more symptoms     of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength,     and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8     weeks to test whether antidepressant medication improves both the syndrome of frailty and     depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and     eligible to participate in the study will be treated with an antidepressant medication and     assessed on the primary outcome variables (characteristics of frailty, depressive symptoms)     as well as on secondary variables which include cognition (global cognition, episodic memory,     executive function), and function (physical mobility, instrumental activities of daily     living, and social functioning) prior to treatment initiation and following 8-weeks of     treatment. The hypotheses for this protocol predict that we will discover a significant     improvement on both frailty characteristics and depressive symptoms in this clinical     population when treated with antidepressant medication (citalopram or duloxetine).   "
100301|NCT01973270|"     The purpose of this study is to determine whether cognitive training exercises can improve     cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective,     schizophreniform, and psychosis NOS who are being treated in community mental health     settings. We will investigate the effects of web-based cognitive training exercises delivered     on a portable laptop computer. The findings will provide us with valuable information on     whether cognitive training can improve the cognition and functioning of young individuals     early in the course of schizophrenia.   "
100302|NCT01973257|"     The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion ability     by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image     with ADC value measurement, and to determine the relationship between these data and the     degeneration of IVDs, the different posture, and different stress-loading status.   "
100303|NCT01973244|"     This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of a single dose of     long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx®     (somatropin) in children with growth hormone deficiency.   "
100304|NCT01973231|"     This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and     safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2     diabetes (T2DM).   "
100305|NCT01973218|"     The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis     Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month     schedule) in Korean adolescents aged between 11 to 17 years.   "
100306|NCT01973205|"     The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin     versus placebo in the acute treatment of migraine   "
100323|NCT01972984|"     1. Women with operable breast cancer with a 2-8 week preoperative waiting period will          accept preoperative therapy trials and specifically taking a standard drug for breast          cancer such as anastrozole in this study        2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER,          PR, Her2, Ki67) within the tumor.        3. Degree of response to short term anastrozole varies with a) duration of treatment and b)          breast cancer subtype (based on initial pre-treatment biomarker status)   "
100310|NCT01973153|"     Leading medical organizations have called on primary care pediatricians to take a central     role in the prevention of childhood obesity. Weight counseling typically has not been     incorporated into routine pediatric practice due to time and training constraints. Brief     interventions with simple behavior change messages are needed to reach high-risk children,     particularly Latino and Black children who are disproportionately affected by obesity and     related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled     trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care     clinicians and the added value of supplementing BMC with monthly contact by community health     workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4     years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized     trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by     clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic     behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly     home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a     specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the     mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are     designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline     and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize     that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone     and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.   "
100311|NCT01973140|"     Tolvaptan is one of new class of medications approved for treatment of low blood sodium     (hyponatremia). It works by interfering with the effect of the antidiuretic hormone,     vasopressin, thereby increasing urine output and decreasing body water. However, the     magnitude of these effects vary from person to person. Thus, the efficacy of tolvaptan is     less reliable than an infusion of a concentrated salt solution for emergency, short term     treatment of hyponatremia.      This study is designed to test 3 hypotheses about the variable efficacy of tolvaptan.        1. The variable effect on urine output is due to individual differences in blood          vasopressin which counteracts the effects of tolvaptan.        2. The differences in blood vasopressin are due to individual differences in the amount          secreted in response to a rise in blood sodium.        3. The variable effect on blood sodium is due mainly to the variable effect on urine output          and can be corrected by maintaining water intake below urine output.      The study has 2 parts and will be performed in 12 healthy adult males.        1. Six subjects will receive tolvaptan at a dose of 60 mg by mouth and six subjects will          receive tolvaptan at 30 mg by mouth. Blood and urine will be collected hourly for 6          hours and water will be ingested in prescribed amounts. For the next 16 hours, subjects          will drink at will and blood and urine will be collected 4 more times.        2. One week later, the same subjects will receive a concentrated salt solution (3% saline)          by vein for 6 hours. During this time, blood and urine will be collected hourly but          drinking will not be permitted. For the next 4 hours, subjects will be allowed to drink          at will while blood and urine are collected twice more.      The volume, concentration and creatinine content of each urine will be determined. Blood will     be analyzed for sodium, vasopressin and, in the first study, tolvaptan.   "
100312|NCT01973127|"     The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on the     right side of the head will make craving towards alcohol less severe in recently detoxified     alcohol addicted patients.      Although there are successful treatment option to detoxify patients form their alcohol use,     many patients tend to relapse. This relapse is mainly caused by a high level of     (uncontrollable) craving towards alcohol. This aspect of addiction is with the existing     options hard to treat, there is a great need of new successful treatment modalities. rTMS is     a FDA approved treatment method for depression. Recently some small scale studies have shown     promising results on rTMS in the treatment of addiction. In this study the investigators     focus on alcohol addiction since it is the addiction with the highest morbidity and mortality     in the Netherlands.   "
100313|NCT01973114|"     The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost     for the treatment of Menière's disease.   "
100314|NCT01973101|"     The purpose of this phase II study is to determine the survival free disease of patients     diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction     chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive     chemoradiation.   "
100315|NCT01973088|"     This study intends to use in patients with renal tissue and blood samples, screening and     identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further     study of uric acid stone formation mechanism and the occurrence of clinical preventive uric     acid stones provide new clues and new intervention targets.   "
100316|NCT01973075|"     Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an     increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function     leading to an early menopause (<40 years of age).Today, only 35% of POI's etiology can be     explained. Causes enlightening POI may be enumerated as follows, according to their     frequency: genetic mutations, autoimmune defects and abnormalities detected on the X     chromosome.The purpose of the study is to determine the frequency of the genetic     abnormalities and polymorphisms described above in the POI Turkish population   "
100317|NCT01973062|"     This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in     treating patients with recurrent or refractory primary central nervous system non-Hodgkin     lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can     find cancer cells and carry cancer-killing substances to them without harming normal cells.     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some     block the ability of cancer to grow and spread. Others find cancer cells and help kill them     or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with     rituximab may kill more cancer cells.   "
100318|NCT01973049|"     To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin     in treatment naive cirrhotic subjects.   "
100319|NCT01973036|"     Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter     for induction in women who present with premature rupture of membranes who are not in labor.   "
100320|NCT01973023|"     Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity     and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies     demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved     kinematic gait parameters(GP) but surprisingly none of them assessed the effects of     repetitive multifocal BTI on patient's gait pattern and their duration.      The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic     stroke patients. To that end, gait of patients has been compared using 3D-gait analysis after     at least 2 consecutive BTI sessions.   "
100321|NCT01973010|"     The purpose of this study is to determine whether massage is effective in the treatment of     low back pain and to optimize clinical therapeutic schedule of massage for low back pain.   "
100324|NCT01972971|"     Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the     prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin     may cause treatment failure and over dosing may cause bleeding because of its narrow     therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and     international normalize ratio (INR) periodically in order to evaluate the appropriateness of     warfarin dosing.      Lots of factors influencing warfarin anticoagulation effects include polymorphisms of     Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes,     age, weight, diet and concurrent medications. Taking into consideration of physicians' work     load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care     in US to ensure patient medication safety. In addition, differences in genetic polymorphisms     between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no     consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation     clinics provide individualized care, consistent monitoring and patient education. Through     this service, physicians can get the latest integrated information about their patients,     patients themselves are more familiar with their medication, and adherence can be improved.     Therefore, those who take warfarin will get better INR control, less adverse drug-related     events and treatment failure.      This is the first prototype of pharmacist clinic for a specific medication in our hospital.     The adverse drug events and coagulation function data collected through this program can be     used for the implementation of warfarin treatment guideline in Taiwan in the future. The     impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge     survey. It can be used as a model for implementing other pharmacist-managed clinics and     improving patient medication safety.   "
100325|NCT01972958|"     As the aging population increases, preventing and decreasing disabilities become a critical     issue for the health care system. Previous researches have shown that preventive     community-based nursing services for older adults could achieve important health benefits at     a relatively low cost. However, many frail and pre-frail older adults living in communities     cannot get enough attention from current health care system. The role and function of nurses     should be expanded to provide more comprehensive family-oriented care to improve health     outcomes of older adults in Taiwan. The objectives of this study are:        1. Understand the difficulties and solutions for nurses providing community-based services          in order to expand their better role and function.        2. Develop a cultural sensitive community advanced nurse service model for Taiwan in health          care system.        3. Explore the effectiveness of community health programs by nurses for frail or pre-frail          older adults in community.      Focus groups and literature review will be used to achieve the first and second study     objectives. A single centre randomized controlled trial will be used in this study to achieve     the third study objective. Two hundred and twenty people aged 65 and over who meet the Fried     definition of frailty and pre-frailty will be recruited from the clinic of a hospital.     Participants will be followed for a 6-month period. Frailty, quality of life, satisfaction to     the services, hospitalizations and admissions to nursing care facilities will be measured and     compared between experimental group and control group. This research is an important step in     the examination of a new approach to the community older people by nurses. The study results     will provide the evidence data to recommendation for related policy making in the future.   "
100326|NCT01972945|"     Inserting a telescope into the womb to identify and treat problems with bleeding, pain or     reproduction is the commonest surgical intervention in gynaecology. This procedure is known     as a 'hysteroscopy'. The established 'traditional' technique for introducing the hysteroscope     into the womb involves the use of a 'speculum', which is inserted into the vagina. A speculum     is the metal or plastic instrument used to stretch and separate the vaginal walls so that the     opening to the womb, known as the 'cervix' can be seen. The cervix is then cleaned and     frequently grasped with a sharp toothed forcep to provide traction before the hysteroscope is     inserted. Whilst hysteroscopy is safe, it is known that pain during the procedure can lead to     a poor patient experience, and even trigger fainting episodes or failure to complete the     procedure. As the hysteroscopes have become smaller, it has been recognised that it is     possible to access the cervix and womb (i.e. 'uterus') directly using the hysteroscopic     vision without inserting any of these potentially pain inducing vaginal instruments. There is     however, uncertainty whether this newer technique known as 'vaginoscopy' or the 'no touch     technique' will minimise the pain experienced by the patient or reduce the propensity to     fainting. Futhermore, even if vaginoscopy is shown to be less painful, the technique may be     more prone to failure due to an inability to transverse the cervix and enter the uterus     without additional instruments. Post-operative infection rates of the uterus may also be     higher due to vaginal contamination.      Reducing pain and complications and improving success of the procedure as well as optimising     patients experience is important because hysteroscopy is an intimate examination, known to be     associated with significant anxiety and pain. Furthermore, the procedure is widely practised     representing the most common surgical intervention in day-to-day gynaecological practice in     the UK and elsewhere. It is therefore important, and timely given that outpatient     hysteroscopy is increasing especially in community settings, that a large, high quality     randomised controlled trial comparing 'vaginoscopy' and the 'traditional' hysteroscopy is     undertaken to resolve the uncertainty as to whether vaginoscopy is less painful, safe and     more successful than existing approaches to hysteroscopy.   "
100327|NCT01972932|"     Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI)     are the most common causes of healthcare associated infectious diarrhea. In light of the     results obtained in a limited number of randomized clinical trials in subjects with AAD and     CDI in comparison with the widespread occurrence of these diseases, it is felt that the     addition of a well-controlled clinical trial in a western environment would add value to     support the use of a specific probiotic to counteract these diseases.   "
100328|NCT01972919|"     This research study is for people who have pancreas cancer for which surgery is not     recommended. Potential patients must have already received several months of chemotherapy     before they are eligible for this study and there will not have been any detectable spread of     their tumor on imaging studies following this chemotherapy course.   "
100329|NCT01972906|"     Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the     effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized     controlled trial. 152 participants will be included. Two arms: moxibustion treatment group     and ibuprofen control group.   "
100330|NCT01972893|"     ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic     cleavage, especially against dipeptidyl peptidase-4 (DPP-IV).      ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human     (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of ZYD1 in normal healthy adult volunteers.   "
100335|NCT01972828|"     Haemodynamic optimization is of paramount importance in septic shock, but is really     consensual and standardized during the first 6 hours of treatment. Haemodynamic treatment     including fluid loading management, vasoactive treatment and oxygen transport optimization is     mainly based on expert recommendations or non-randomized trials. Recently, preload dependence     indexes such as pulse pressure variation have been shown to be more accurate to predict fluid     responsiveness than static indexes such as filling pressures. However, whether using preload     dependence indexes changes septic shock prognostic remains to date unknown. The aim of this     non-blinded randomized controlled trial is to assess whether haemodynamic optimization using     preload dependence indexes and pulmonary thermodilution 1. reduces septic shock duration     assessed by administration duration of vasoactive treatment (primary end point), 2. reduces     regional hypoperfusion assessed by arterial lactate, 3. reduces lung hydrostatic oedema     linked to excessive fluid loading (assessed by PaO2/FIO2 ratio and extravascular lung water).     4. reduces organ dysfunction (assessed by the SOFA score), ICU stay and 7 and 28 day     mortality Control group is managed with an algorithm using filling pressures to drive     haemodynamic treatment.   "
100336|NCT01972815|"     Nasopharyngeal carcinoma (NPC) is a virus-associated cancer that is rare among Caucasians but     occurs at an elevated rate among Southern Asians. Rates of NPC are particularly high among     individuals with a family history of this disease, but no specific genetic factors have been     identified that can serve to guide clinical management of this high-risk population to ensure     early detection and treatment of this life-threatening condition.   "
100337|NCT01972802|"     Our overall objective is to understand the role of lifestyle factors, genetics and HPV     infection in the development and prognosis of head and neck cancer particularly in Asia.   "
100338|NCT01972789|"     To evaluate and compare two individualised ranibizumab treatment regimens, differentiated by     the definition of disease activity which determines the treatment interval until the next     injection. The results will be used to generate further recommendations about intensive     versus relaxed treatment approaches and how they can be utilised within an 'inject and     extend' approach to maximise patient outcomes, while reducing the need for potentially     unnecessary intravitreal injections. This study will also investigate genotypic expression     and response to intravitreal injections of ranibizumab between the two treatment arms.      The study hypothesis is that intravitreal ranibizumab when administered to resolve IRF only     results in visual acuity benefit that is not clinically worse than intravitreal ranibizumab     when administered to completely resolve both IRF and SRF in patients with wet AMD.   "
100339|NCT01972776|"     This was a 2 Part study. Part 1 was a safety and tolerability study in GOLD I-III COPD     patients. Part 2 was an efficacy study in GOLD I-III COPD patients.   "
100340|NCT01972763|"     The purpose of the study is to determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg in     subjects who were previously treated with Bevacizumab and subsequently switched to     Aflibercept. These subjects have demonstrated a sub-optimal therapeutic response to the     previous therapies; therefore, the study aims to see if Ranibizumab may have a greater     treatment effect.   "
100341|NCT01972750|"     In this study with a modified 3+3 dose finding design, a safe and tolerable dose of TKI258 in     patients with relapsed glioblastoma should be established.   "
100342|NCT01972737|"     The purpose of this study is to determine the safety, tolerability and ability to stimulate     hGCC-specific antibody and killer T cell immune responses of an Ad5-hGCC-PADRE vaccine in     stage I and stage II Caucasian and African American colon cancer patients.   "
100343|NCT01972724|"     The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic     control as when used in patients with inadequately controlled type 2 diabetes mellitus     treated with fixed combinations of metformin and sulfonylurea.   "
100344|NCT01972711|"     This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male     and female volunteers with high or low schizotype characteristics.   "
100345|NCT01972698|"     The purpose of this study is to determine whether a self-directed and simulation-based lung     ultrasound (LUS) and focused cardiac ultrasound (FCU) curriculum is efficacious on anesthesia     trainees' image acquisition skills and diagnostic acumen. The investigators hypothesize that     a self-directed and ultrasound-assisted LUS and FCU curriculum that includes video lectures,     online teaching modules, an ultrasound simulator, and self-directed hands-on sessions on     critically ill mechanically ventilated patients is effective in training novice     ultrasonographers to obtain good quality images, to correctly interpret them, and to support     clinical decision-making in critically ill patients.      Trainees will be randomized to fully supervised FCU hands-on sessions on healthy models and     critically ill mechanically ventilated patients (control group - traditional apprenticeship     model) or to a completely self-directed and simulation-based approach (intervention group).      To assess if this new self-directed and simulation-based ultrasound curriculum leads to     adequate acquisition of competences (adequate image acquisition and interpretation) in novice     ultrasonographers, trainees will have to perform a focused lung and cardiac assessment on a     critically ill mechanically ventilated patient.   "
100346|NCT01972685|"     The objective of this study is to compare the sample size, architectural preservation and     diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) to     bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted Thoracoscopic     Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease (ILD).   "
100347|NCT01972672|"     The primary objective of the study is to assess the time to progression (TTP) in patients     with advanced HCC treated with Icaritin .   "
100358|NCT01972529|"     This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group     study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.     The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with     liver disease prior to an elective procedure to reduce the need for platelet transfusions or     any rescue procedure for bleeding due to procedural and post-procedural bleeding     complications. Participants will be enrolled into 2 cohorts according to mean baseline     platelet count and, within each baseline platelet count cohort will be further stratified by     risk of bleeding associated with the elective procedure (low, moderate, or high) and     hepatocellular carcinoma (HCC) status (Yes or No).   "
111944|NCT01820650|"     This study is designed to observe the long term clinical outcomes of patient-specific knee     arthroplasty in patients with osteoarthritis.   "
100348|NCT01972659|"     Background: The aim of this prospective study was to evaluate the effect of magnesium on the     reversal of rocuronium-induced neuromuscular block by sugammadex.      Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II,     undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with     propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane.     The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a     bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo     group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium     was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more     during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv     was administered. Patients were observed until a TOF ratio of 0.9 was achieved.     Patient-controlled analgesia with intravenous morphine was used postoperatively.   "
100349|NCT01972646|"     Introduction: Despite several expert panel recommendations and cellulitis treatment     guidelines, there are currently no clinical decision rules to assist clinicians in deciding     which emergency department (ED) patients should be treated with oral antibiotics and which     patients require intravenous therapy at first presentation of uncomplicated cellulitis. The     objective of this prospective study is to determine potential patient risk factors associated     with adult patients (>17years) presenting to the ED with a concern about a skin or soft     tissue infection who fail initial antibiotic therapy for the treatment of standard cellulitis     and require a change of antibiotics or admission to hospital.      Methods: This study will be a prospective study conducted in two tertiary care EDs. Patients     will be excluded if they have been treated with antibiotics for the current bout of     cellulitis prior to presenting to the ED, patients admitted to hospital and those patients     with abscesses only. Hired research assistants (RAs) will administer a questionnaire at the     initial ED visit with telephone follow-up 2 weeks later. Treatment failure will be defined as     patients requiring subsequent hospitalization, initiation of intravenous antibiotics (if oral     antibiotics were prescribed initially), or a change of oral antibiotics for the original     cellulitis.      Results: This study will provide a detailed profile of patient risk factors associated with     treatment failure of cellulitis. The results will be analyzed and used in formulating a     clinical decision rule for effective treatment of cellulitis presenting to the ED. Each of     the predictor variables associated (p ≤ 0.1) with failed treatment in the univariate analysis     will be considered in a multivariate logistic regression model. Additionally, treatment     variability among clinicians in regard to cellulitis will be evaluated and compared to     treatment failures, thus providing data on successful treatment regimens.      Conclusions: Results from this research may be used to generate a clinical prediction rule to     assist clinicians in effectively treating patients presenting to emergency departments with     cellulitis. Understanding which patient risk factors for treatment failure will assist     clinicians in determining which patients will benefit from intravenous versus oral     antibiotics.   "
100350|NCT01972633|"     There is a difference concerning obliteration rate and postoperative pain after treatment of     the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .   "
100351|NCT01972620|"     Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients     undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical     cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after     laparoscopic cholecystectomy.   "
100352|NCT01972607|"     This study has been designed in order to know the effect of 12 weeks of aerobic exercise     training for migraine prevention. We hypothesized that the exercise training could reduce the     number of days with migraine and the number of attacks per month in the treated group.   "
100353|NCT01972594|"     Total hip replacement is designed to alleviate pain, reduce disability and improve function     and physical activity levels. Whilst pain, disability and function are often measured     following surgery, actual physical activity is not. The aim of rehabilitation after total hip     replacement would be to obtain optimal strength and range of movement at the hip along with     cumulative endurance and balance. It is taken for granted that, once function is restored,     the patient returns to physical activity levels associated with good health. In a previous     study conducted by the same team it was observed that patients, at the end of 3 months after     hip surgery, do not reach the levels of physical activity which are proven to be beneficial     for health. Physiotherapy plays an important role in improving function and increasing levels     of Physical activity in total hip replacement patients, but there is limited literature to     substantiate this claim. There is a need to enhance levels of physical activity in patient     after total hip replacement towards levels that are associated with good health. This study     aims to demonstrate a method of enhancing physical activity levels after total hip     replacement using a pedometer based intervention over a period of 3 months. Patients will     follow a customized progressive stepping activity schedule aimed at establishing levels of     physical activity that are associated with good health. To fully understand recovery patterns     subjective and objective measures of strength of the hip muscles, range of motion at the hip,     overall endurance, balance and speed of walking of the patient will be assessed.     Questionnaires will be utilized to assess quality of life both before and after total hip     surgery. The physical activity levels of the patient will be measured with a physical     activity monitor. This study will be completed at the Golden Jubilee National Hospital at     Glasgow.   "
100354|NCT01972581|"     Incorporating neurocognitive visual reaction training has been shown to increase bating     performance in collegiate baseball players. However, poor methodology, such as lack of a     control group and use of an unreliable outcome measure, limit the strength of the previous     study. Therefore the purpose of this study is to determine the effects of neurocognitive     visual reaction training on reaction time and coordination in an athletic population.      The purpose of this study is to determine the effects of neurocognitive visual reaction     training on reaction time and coordination.   "
100355|NCT01972568|"     This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of     atacicept in subjects with systemic lupus erythematosus (SLE).   "
100356|NCT01972555|"     This is a single-center, open-label, randomized controlled trial. Patients scheduled for     aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be     eligible. Forty patients will be randomly assigned to either minimally invasive (20 patients)     or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and bioprosthetic     aortic valves (conventional stented or sutureless bioprostheses) will be implanted.     Transthoracic echocardiography will be performed before surgery, and at day 1, 4, and 40.     Echocardiographic parameters as well as preoperative clinical characteristics and     postoperative clinical outcomes will be registered. Routine blood sampling will be performed     pre- and postoperatively. All available data will be collected prospectively. Informed     consent will be obtained from patients meeting the inclusion criteria before the initiation     of any study-specific procedures.   "
100357|NCT01972542|"     The hypertriglyceridemia at fasting status has been known to be an important risk factor for     cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an     attention as a superior predictor of CVD because of non-fasting state for more than 12 hours     and importance of triglyceride-rich lipoprotein.      We aim to investigate the relationship of postprandial triglyceride after fat tolerance test     and intima-medial thickness and to suggest normal reference of postprandial triglyceride     after fat tolerance test. In addition, we evaluate the correlation of postprandial     triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate     clinical importance of postprandial triglyceride in assessment of cardiovascular risk.   "
100367|NCT01972412|"     The purpose of this study is to determine whether phone use contributes to diabetes control.   "
104191|NCT01922336|"     The purpose of this study is to compare the pharmacokinetics, safety, tolerability and     immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy     subjects.   "
100359|NCT01972516|"     This research study is evaluating a drug called tivozanib as a possible treatment for     ovarian, fallopian tube or primary peritoneal cancer.      Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and     spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a     tumor's blood supply so that it does not get the blood and nutrients it needs to grow.      In this research study, the Investigators are looking to see whether tivozanib works as a     maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in     participants who have achieved a complete response following chemotherapy. Maintenance     therapy is given after a disease has responded to previous treatment. It is given to help     prevent the spread or recurrence of the tumor.   "
100360|NCT01972503|"     In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU     and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal     cancer resection.   "
100361|NCT01972490|"     In this study, the investigators assessed the effect of avastin in combination with     chemotherapy in the treatment of unresectable metastatic colorectal cancer.   "
100362|NCT01972477|"     This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind     clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in     elevating high density lipoprotein (HDL) cholesterol in diabetic patients. The hypothesis of     interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol level     from baseline to the end of study significantly higher than the elevation resulted by     placebo. In addition, the administration of DLBS1449 at the dose of 150 mg daily will provide     a significantly better response than that of the lower dose (DLBS1449 75 mg daily).   "
100363|NCT01972464|"     Smoking is the main preventable cause of mortality in Western countries, contributing to over     430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women     often decrease smoking in pregnancy, when progesterone levels are high. However, at least     half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone     levels drop.      Data from preclinical and clinical studies suggest that progesterone may be effective in     preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone     decreases both craving for cigarettes and the subjective rewarding effects of smoking among     recently abstinent female smokers. These findings led us to hypothesize that progesterone may     have efficacy as a relapse prevention treatment for postpartum women.      We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of     progesterone. This will be a feasibility study that will compare progesterone to placebo for     relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety,     including the potential effects on breastfeeding and infants exposed via breast milk, in     addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at     follow-up, 3-months after the end of the protocol.   "
100364|NCT01972451|"     The Bowel Cancer Screening program was implemented to address the important issue of     prevention and early detection of bowel cancer. Results from the first few years of screening     and previous smaller studies show that while in its current form it will save many lives,     there continue to be polyps and cancers in the upper large bowel (right side) that may be     difficult to detect. There is some evidence that these types of polyps (serrated polyps) may     be at least partly responsible for cancers missed at the initial colonoscopy and have a     faster rate of growth to cancer compared to conventional polyps (adenomas). We propose to     examine participants undergoing screening colonoscopy with the addition of a contrast dye ( a     safe food colouring agent base already used in various bowel camera procedures in standard     clinical practice). This has been shown to improve detection of conventional polyps     significantly even though it is considered by some to be more time consuming (possibly taking     a few minutes longer) and requiring specific training to undertake. We hope to study the     feasibility of undertaking these procedures to improve detection and removal of these polyps     within the bowel screening program and potentially inform further studies to assess the     impact of improved detection and consequent potentially reduced incidence of interval or     missed bowel cancers in longer term follow up. Thus the main aims of this feasibility study     are to assess if this type of procedure would be feasible to implement and acceptable to     participants, colonoscopists and the screening program and also assess any additional time or     costs involved to inform the question of if a larger study should then be undertaken to     conclusively prove or disprove the merits of this approach in terms of health economics,     cancer detection and survival.   "
100365|NCT01972438|"     Some eye diseases can be helped by eye drops made from a person's own blood. These eye drops     are called autologous serum eye drops, or ASEDs. ASEDs have been studied in only a few people     with graft vs. host disease (GVHD) affecting the eye and were found to be helpful with few     side effects.      The purpose of this study was to determine whether ASEDs are safe and more effective than     control (normal saline) and can help with eye symptoms in people with severe chronic eye     GVHD.      Each participant in this study was to have blood drawn to prepare ASEDs specifically for the     participant. Each participant was scheduled to receive ASEDs for 3 months and placebo eye     drops (salt water) for 3 months. Participants did not know when they were receiving the ASEDs     and when they were receiving placebo eye drops.   "
100366|NCT01972425|"     Critically ill patients whose lungs are supported by breathing machines (ventilators)     commonly develop a new lung infection, called ventilator-associated pneumonia (VAP). Because     VAP is often fatal, antibiotics are administered whenever it is suspected. However VAP is     hard to distinguish from several non-infective lung conditions and most patients with     suspected VAP do not have pneumonia. Therefore many patients receive unnecessary antibiotics     for several days, promoting emergence of 'superbugs'. Laboratory test results for diagnosing     VAP typically only reach the doctors after 3 days.      A simple test rapidly and confidently excluding VAP should improve patient care, reduce     unnecessary antibiotics and decrease costs. We recently showed that low levels of specific     proteins in fluid from the lungs of patients with suspected VAP effectively excluded VAP,     using a test that may yield results within 6 hours. The test used is an extension of existing     technology produced by our commercial partner Becton Dickinson (BD) Biosciences.      Our previous findings were derived from a single hospital's intensive care unit. We have     recently confirmed this finding across many intensive care units, which will help show that     the test can be used in 'real life'. The aim of this study is to take the new test to the     next step and determine whether it can improve the care of patients by reducing the amount of     unnecessary antibiotics prescribed. This will be done using a 'randomised controlled trial',     the best tool for scientifically testing a new diagnostic test. To do this we shall identify     patients with suspected VAP, all of whom will have a lung sample - half of the patients will     receive 'usual care' for suspected VAP, the other half will have the new test performed on     their lung fluid. If the new test suggests no lung infection, the doctors will be asked to     consider not giving antibiotics. We shall test how much antibiotic is given to each group.   "
116771|NCT01757470|"     Effectiveness of risk minimisation interventions for vandetanib in Canada   "
100370|NCT01972373|"     To improve rectal cancer management, there is a need for better visualization of drug targets     in rectal cancer to identify patients who might benefit from specific targeted treatments.     Molecular imaging of rectal cancer associated targets is a promising technique to accommodate     this need. Vascular Endothelial Growth Factor (VEGF), which is differentially expressed in     normal versus malignant colon tissue, has proven to be a valid target for molecular imaging.     Fluorescent labeling of bevacizumab (a VEGF targeting humanized monoclonal antibody currently     used in anti-cancer therapy) using IRDye800CW (a fluorescent dye) has potential advantages in     view of safety, infrastructure, costs, stability and imaging resolution. Therefore, the     fluorescent tracer bevacizumab-IRDye800CW has been developed at the University Medical Center     Groningen (UMCG) and was recently approved to be administered to patients in a tracer dose.     To detect this tracer in vivo in patients with colorectal cancer, a newly developed flexible     near-infrared (NIR) fluorescence endoscope and optoacoustic endoscope have been developed     which can be used in clinical studies. Optical fluorescence imaging may support response     evaluation following chemoradiotherapy and give insight which patient might benefit from     anti-VEGF targeted therapy in future studies.   "
100371|NCT01972360|"     SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well     as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing     the use of non-isotope based imaging modalities has the potential to change the standard of     care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography)     has its own distinct potential advantages over SPECT.   "
100372|NCT01972347|"     This is an open label, single centre, phase II study of neoadjuvant drug treatment with     dabrafenib + trametinib in patients with resectable American Joint Committee on Cancer (AJCC)     Stage IIIB-C BRAF V600 mutation positive melanoma.      The main aim of this study is to find out if giving of a new combined drug treatment to     patients with melanoma that has spread to the lymph nodes BEFORE they have surgery, will     result in improved clinical and pathological response of the melanoma tissue after 12 weeks     treatment.   "
100373|NCT01972334|"     The incidence of C. difficile infection (CDI) has alarmingly increased over the past several     years and the affected population has expanded to include those previously at low risk, such     as children. The annual US financial burden associated with this infection is great and     estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial     ecology is disrupted during interventions notorious for perturbing the delicate microbial     balance. A well known and common example is the use of antibiotics. Fecal microbiota     transplant (FMT) has been introduced several decades ago in an attempt to restore the gut     microbial balance. To this date there have been a great number of reports of success in     eliminating recurrent C. difficile infections and restoring the gut microbial profile to     resemble that of the healthy donor. While over 300 cases have been described in the     literature, there has been no pediatric controlled studies performed to compare its efficacy     to placebo. Therefore, there is a strong need to determine their safety and efficacy in     pediatric randomized controlled studies. The investigators hypothesize that children with     recurrent C. difficile infection will respond to fecal transplant therapy which will modify     their gut microbial profile. The investigators propose a randomized, placebo controlled,     pilot study of fecal microbial transplant in children with recurrent C. difficile infection     to evaluate the safety and efficacy of fecal microbial transplant in children in preventing     recurrent C. difficile infection. The investigators anticipate that fecal microbial     transplant in children with recurrent C. difficile infection will be safe and efficacious and     will provide these children with a great alternative to a disease that is difficult to treat.     Results of this study will establish the major role of the gut microbiome in this disease and     demonstrate the viability of gut microbial transplant in recipients.   "
100374|NCT01972321|"     The aim of the inSCALE project is to test the effect of innovative approaches to increase     coverage of integrated community case management, which provides community based-care for     diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate     care for these three most common childhood illnesses   "
100375|NCT01972308|"     Few interventions to improve asthma management have targeted low-income minority asthmatic     adults and even fewer have focused on the real-world practice where care is provided for     these patients. This project tests the effectiveness of a Patient Advocate as a practical and     sustainable method of facilitating and maintaining communication between patient and provider     and access to chronic care for adults with moderate or severe asthma recruited from clinics     serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current     asthma care and test the Patient Advocate's cost-effectiveness.   "
100376|NCT01972295|"     This is an observational, prospective, non-randomized, multicenter study with the following     objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial     Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a     commercial clinical setting and (2) to collect health care usage data that may be needed for     reimbursement of WATCHMAN technology in certain countries.   "
100377|NCT01972282|"     The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may     form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic     thromboembolism. The objectives of this observational, prospective, non-randomized     multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left     atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in     a commercial clinical setting and (2) to collect real-world usage data that may be needed for     reimbursement of WATCHMAN technology in certain countries.   "
100378|NCT01972269|"     Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the     most commonly used drugs for that purpose. The efficacy of a certain medication injected     epidurally depends on the dose that is given. A certain dose can be administered in different     concentrations, which will consequently mean different volumes. Studies have been done to     determine volumes for different concentrations of bupivacaine. However, those studies fall     short in the sense that this information cannot be readily applicable in clinical practice,     as we don't use bupivacaine plain. The combination of bupivacaine and fentanyl or sufentanil     is common practice, as it is well established that the opioids will reduce the concentration     of local anesthetic required to produce optimal effect with the least side effects.      This study is being planned to determine and compare the EV90 of the bupivacaine     0.125%-fentanyl mixture for initiation of labor epidural analgesia, following the     administration of the 2 different test doses (3cc of lidocaine 2% or 3cc of the bupivacaine     0.125%-fentanyl mixture) used in our Department.   "
100413|NCT01971814|"     The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive     of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum     infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely     correlated with serum infliximab levels.      In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab,     we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively     associated with clinical response and avoidance of colectomy.   "
100379|NCT01972256|"     The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion     procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or     bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to     transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or     bilateral supplemental screw fixation as an adjunct to fusion.      Subject candidates are those who had previously required and received fusion at L4-L5-S1     where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis,     spondylolisthesis, or degenerative disc disease (DDD).   "
100380|NCT01972243|"     Because of a high recurrence risk after unprovoked venous thromboembolism (VTE) indefinite     anticoagulation is recommended, but confers a considerable bleeding risk. It is important to     identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and     who will not benefit from long term anticoagulation. By use of a scoring model (Vienna     Prediction Model), patients can be stratified according to their recurrence risk based on     their sex, location of VTE and D-Dimer. Before implementation in routine care, an independent     validation is required. Patients with unprovoked VTE will stop anticoagulation after 3-7     months and the recurrence risk will be estimated by use of the Vienna Prediction Model. Low     risk patients with a score of <180 will be included and will be left untreated. Patients with     a high score will not be included and their management will follow current guidelines.     Follow-up will be two years and the endpoint will be recurrent symptomatic VTE.   "
100381|NCT01972230|"     This study aimed to evaluate the possible protective effect of anesthetic technique balanced     (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion     injury in microvascular flap in plastic surgery. The investigators will evaluate the     viability of the flap using tissue oximetry monitoring and the level of biochemical markers     in a circle at the end of the intervention.   "
100382|NCT01972217|"     This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety     run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when     given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind,     placebo controlled comparison of the efficacy, safety and tolerability of the dose of     olaparib selected from Part A when given in addition to abiraterone, versus placebo given in     addition to abiraterone. Abiraterone is indicated in combination with prednisone or     prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5     mg twice daily (bid) will be administered with the abiraterone in this study.   "
100383|NCT01972204|"     The purpose of this study is to examine the influence of the instruction on the use of     Aricept with educational brochure on the 48-week medication persistence and to assess the     reasons for discontinuation.   "
100384|NCT01972191|"     Before astigmatism reducing surgery, accurate corneal horizontal marking before surgery is     important. Due to new corneal topographic method, iTrace™ surgical workstation, precise     evaluation of corneal horizontal marking is available. In this study the investigators     compared three known corneal horizontal making techniques and evaluate accuracy of each     methods using iTrace™.   "
100385|NCT01972178|"     The objective of this study is        -  To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood          lipids and lipoprotein parameter from baseline after 12 weeks of treatment        -  To evaluate the safety of PRC-4016 as assessed by adverse events and other safety          parameters   "
100386|NCT01972165|"     A few studies have shown that the mini-incision release technique decreases the pathologic     swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening     ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic     release technique similarly reverses these pathological changes in the median nerve along the     carpal tunnel in patients with CTS compared with the mini-incision release.      Investigators therefore conducted the current study to compare the subjective outcomes and     US-measured morphological changes in the median nerve in patients with CTS who received     either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective     outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function     scores and the DASH scores, would be similar 24 weeks after either mini-incision or     endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each     level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks     after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes     would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or     endoscopic carpal tunnel release.   "
100387|NCT01972152|"     The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly     Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a     complication of diabetes.   "
100388|NCT01972139|"     An international, multi-center, prospective, blinded, randomized, controlled trial. The     objective is to demonstrate that catheter-based renal denervation is an effective and safe     treatment for uncontrolled hypertension.   "
100389|NCT01972126|"     The MAGNetic QRS-Fragmentation in Patients with Myocardial InfarcTion and Moderately RedUceD     Ejection Fraction (MAGNITUDE) study will assess in MI survivors with moderately reduced left     ventricular function, whether non-invasive MFI QRS Fragmentation alone or in combination with     parameters derived from a Holter recording can be used to identify a group of patients at     high risk for SCD/life threatening ventricular arrhythmia.   "
100390|NCT01972113|"     The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and     matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular     disease (at least in mouse models). Clinical trials are needed to isolate the effects of     vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA     protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk.     The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is     to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve     carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect     on markers associated with diabetes and cardiovascular disease risk.   "
100391|NCT01972100|"     The study hypothesis is a improved muscle fatigue resistance induced by low-level laser     therapy applied between sets of intense exercises.   "
104192|NCT01922323|"     The PI will study metabolism during liver regeneration in living liver donors   "
136039|NCT01504113|"     Background:      Psoriasis is a chronic, immunologically-mediated, inflammatory skin disease and targeted     therapies e.g. tumor necrosis factor (TNF)-α and TH-17 antagonists have become increasing     important agents in the management of psoriasis. TNF, interleukin-17 (IL-17) and TH-17 play     major roles in defense against infection. Large-scaled clinical trials and post-marking     surveillance had shown these agents may increase susceptibility to infections. Most studies     evaluate the reactivation of tuberculosis but the influence of targeted therapies on the     viral infection has not been extensively investigated.      TNF-α has been shown to contribute to the killing of cytomegalovirus (CMV)- and human     papillomaviruses (HPV)-infected cells. Additionally, recent studies have shown a high     prevalence of HPV DNA in psoriatic skin and increased HPV5 antibodies in patients with     psoriasis. The prevalence of HPV in the skin was also affected by therapeutic modalities,     such as psoralen-ultraviolet A (PUVA). Several case reports in which CMV, Epstein-Barr virus     (EBV) and HPV infection complicated therapy with TNF-α antagonists have been reported.     However, the study investigated the effect of TNF-α antagonists and other biologics on     reactivation of latent viruses is limited. Only two studies investigated the short-term     effect of infliximab on reaction of herpesviruses in patients of rheumatoid arthritis and     Crohn's disease. The high prevalence of combination use of immunosuppressants, such as     methotrexate alongside with TNF-α antagonists in these patients is different from patients     with psoriasis. Additionally, various bacterium and fungi, such as Staphylococcus aureus,     Malassezia are associated with provocation and/or exacerbation of psoriasis and recent     studies had shown IL-17 is essential for the immune response to common fungus Candida     albicans.      Aim:      The aim of this study is to prospectively investigate the effect of target therapies (TNF-α,     TH-17 antagonist, IL-17 antagonists, tofacitinib and apremilast) on the activation of     viruses, including CMV, EBV and HPV and the impact of biologics on the prevalence of surface     colonization of microorganism, including HPV, bacteria and fungi, in patients with psoriasis.      Methods and procedures:      Our project consists of two related study. The first (Study 1), a prospective observational     study, included patients with psoriasis who are going to undergo biologics therapy, the viral     loads of CMV and EBV, HPV DNA detection in eyebrow hairs and skin scales, and bacterial,     fungal cultures from skin scales were performed before the initiation, 12 and 24 weeks after     initiation of the target therapies, 12 weeks after discontinuation of target therapies. This     part of our project is to investigate the dynamic effect of biologics on the microorganisms     in patients with psoriasis. The second part (Study 2), a case control study, recruits     psoriasis patients who have started target therapies, they receive the sampling of blood,     eyebrow hairs and skin scales for CMV, EBV and HPV investigations when they are enrolled.     Control group compromised of age-and disease severity-matched psoriasis patients who are not     treating with target therapies or other systemic antipsoriatic agents. Comparison of the     prevalence of latent virus, virus reactivation, bacteria and fungi skin colonization between     psoriasis patients who are treating with and without target therapies is performed. The aim     of study 2 was to assess any difference of the status of latent virus or microorganism     colonization in skins between psoriasis patients treated with and without target therapies.   "
100392|NCT01972087|"     This study is to test the use of simulation training to improve 9-1-1 telecommunicators' call     processing and response. Training sessions will expose 9-1-1 telecommunicators to several     realistic emergency situations through mock 9-1-1 calls with a trained actor playing the part     of a reporting party, followed immediately by feedback on call handling provided by a trained     call observer. Investigators hypothesize that simulation followed by trained     observer-directed feedback will increase correct triage of medical emergency and delivery of     pre-arrival instructions during simulated calls and in actual 9-1-1 calls.   "
100393|NCT01972074|"     This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for     the treatment for social impairment in adolescents with autism spectrum disorder (ASD). The     investigators will also conduct pre- and post-treatment neuroimaging (fMRI and HMRS) to     assess neural functional deficits in adolescents with ASD compared to healthy volunteer     adolescents and to assess any effects of memantine therapy on neural function in adolescents     with ASD. The investigators hypothesize that short-term memantine monotherapy will be safe,     well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in     adolescents with ASD. Additionally, the investigators hypothesize that following memantine     therapy, ASD subjects will exhibit a decrease in glutamate (Glu) concentration in the     anterior-cingulate cortex (ACC) and a change towards normalization in altered functional     connectivity of the ACC and medial temporal lobes, consistent with improvement in social     impairments in ASD. The investigators hypothesize that compared to healthy volunteer     subjects, ASD subjects will significantly differ on neuroimaging measures at baseline but     that following memantine therapy, the difference between ASD and healthy volunteer     neuroimaging data will decrease.   "
100394|NCT01972061|"     The purpose of this study is to determine if electrical stimulation of the foot is effective     in the treatment of overactive bladder conditions.   "
100395|NCT01972048|"     Korean American (KA) women have among the highest breast cancer mortality rates and lowest     breast cancer screening rates of U.S. American women across racial/ethical groups. This     innovative project seeks to harness mobile phone technology as a means to take preventative     health care to a new level among this population. Using the Fogg Behavioral Model this study     proposes to develop a mobile phone-based intervention designed to motivate KA women to     undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the     feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA     women to undergo breast cancer screening.   "
100396|NCT01972035|"     Our study will compare all kidney transplant recipients receiving valganciclovir vs.     valacyclovir for one year following kidney transplant and compare:        1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after          transplant.        2. the side effects of the anti-viral drugs requiring dose reduction or cessation      In addition, we will test renal tissue obtained from any biopsies post-transplant     (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and     fluorescence in situ hybridization to assess for latent CMV and/or EBV.   "
100397|NCT01972022|"     First prospective randomized controlled study to evaluate in an 'all-comers' population with     coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a     biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with     respect to the long term vascular response to treatment These data are important to ascertain     the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long     term development of in-stent neoatherosclerosis.   "
100398|NCT01972009|"     The mechanism governing how blood flows from the heart to the lungs depends on many factors     including the pumping function of the right ventricle, properties of the arteries that carry     the blood from the right ventricle to the lungs (pulmonary arteries), and the lungs     themselves.      Under normal conditions the pressure in the pulmonary arteries is well controlled and     significantly lower than in the systemic circulation, however there are a number of     conditions that lead to abnormally high pressures and significant morbidity and mortality.      However different patients respond differently to similarly elevated pressures, leading     doctors to believe that there must be differences in either the right ventricles, the     properties of the arteries, or the lungs themselves. It can be difficult to determine the     relative contributions of each of these factors on blood flow because their effects are     superimposed on each other.      One approach that has been used to look at this in other parts of the circulation (including     in the systemic circulation and the coronary arteries) is to measure simultaneous pressure     and flow, and apply a technique called wave intensity analysis (WIA). This technique can     amongst other things, quantify the separate effects of wave reflection and the 'reservoir     function' (or compliance) of the arteries, and in the systemic circulation WIA has increased     the understanding of the mechanisms behind hypertension and the physiological changes of     ageing. The pulmonary arteries are accepted to be very different from the systemic     circulation and the mechanisms behind pulmonary hypertension are thought to be very different     to those of systemic hypertension.      This protocol aims to determine the major influences on blood flow in the pulmonary arteries     in health and disease, to help to understand why some patients are affected more than others     by elevated pulmonary pressures.   "
100399|NCT01971996|"     During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS     technology can be used. It consist of two sensors placed on the forehead, and measures the     oxygen saturation of the tissue underneath the sensor. For patients undergoing back surgery     placed in the prone position, the NIRS measurement will be affected, because the weight of     the head will produce a pressure on the sensors. We wish to investigate how much the     measurement is affected. Furthermore we plan to lift the head to remove the pressure, and     record the time needed for the measurements to return to baseline.   "
100400|NCT01971983|"     The objective of this randomized controlled trial is to describe the effect of two     osteopathic techniques - high velocity, low amplitude (HVLA) and muscle energy (ME) - on     thickness, activation, strength, pressure pain threshold (PPT) of the paravertebral muscles     at the lumbar spine, as well as the peak plantar pressures immediately and after a two-day     follow-up.      The muscle thickness of the paravertebral muscles at the lumbar spine, namely internal     oblique, external oblique and transversus abdominis can be altered after the application of     'high-velocity low-amplitude'(HVLA)and 'muscle energy' (ME)techniques immediately and after a     two-day follow-up.   "
100425|NCT01971658|"     This is a phase III, multicenter, prospective with a clinical benefit, open-label and     randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide     Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an     Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly     Diagnosed Multiple Myeloma.      Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4     consecutive 21 day cycles of an induction treatment with either VTD or VCD.   "
100426|NCT01971645|"     If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2     mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.   "
100401|NCT01971970|"     Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for     refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction     (primary response) and maintenance of remission. When effective, clinical and endoscopic     remission is reached within weeks. However, primary non-response is observed in 20% of     pediatric patients, and in 40% of adult CD patients, suggesting a more robust acute response     to anti-TNF therapy in children as compared to adults.During maintenance treatment, 60 - 80%     of patients have secondary loss of response, necessitating dose adjustments to maintain     clinical response. Anti-TNF treatment is also increasingly used in ulcerative colitis (UC),     and has been shown to induce remission in active disease. For UC, the comparison between the     efficacy in children versus adults is more difficult to report as studies in children are     scarce. Anti-TNF treatment is associated with rare but potentially fatal side effects,     infusion reactions, and is an expensive treatment. To avoid overtreatment it is necessary to     early identify non-responders to treatment, and therefore it is important to develop     predictive biomarkers of treatment response.   "
100402|NCT01971957|"     Sjogren-Larsson syndrome (SLS) is a rare genetic disease in which patients typically exhibit     ichthyosis (dry, scaly skin), intellectual disability, spasticity, seizures and a distinctive     maculopathy. The purpose of this study is to define the clinical spectrum and natural history     of Sjogren-Larsson syndrome, and identify biomarkers that correlate with disease phenotype     while establishing a registry for future investigations of biochemical pathogenesis and     therapy.   "
100403|NCT01971944|"     Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized     patients who are receiving Beta Blocker Participants: Patients who are admitted to the     General Cardiology and Heart Failure Services at the University of North Carolina Hospitals     with acute decompensated heart failure, who have maintained steady state concentrations of     beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team     to require pulmonary artery catheter placement and inotropic therapy with dobutamine or     milrinone by continuous infusion. Patients that are not currently receiving beta blocker     therapy will be enrolled for comparative purposes; however, any patient not at steady state     (on or off beta blocker therapy) will not be enrolled.      Procedures: After obtaining informed consent, patients will be assigned to the appropriate     sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol     and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine     followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm     attached, as part of the usual standard of practice). Baseline pulmonary artery catheter     hemodynamic parameters will be collected prior to administration of inotrope trial of     dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing     algorithm following initiation and dose titration. Dose titration will be determined by the     health care team based upon patient response or lack thereof and tolerability. Changes in     hemodynamic parameters in response to dobutamine or milrinone will be compared within study     groups. Additionally, data will continue to be collected on patients receiving not beta     blocker therapy for comparative purpose.   "
100404|NCT01971931|"     Bone quality is an important factor influencing the outcome of total knee replacement (TKR)     surgery. Therefore, assessing bone quality preoperatively could help the surgeon in the     choice of the most appropriate prosthetic implant.      The primary goal of this study is to measure serum and tissue levels of some proteins     involved in bone remodelling.   "
100405|NCT01971918|"     The objective of the study is to evaluate two therapeutic strategies: early switch or     therapeutic intensification in patients with spondyloarthritis in case of secondary     treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of     ASDAS and positivity to ADAb.      Patients and Methods:      Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of     follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or     adalimumab will be included if their ADAb dosage is positive, and they will be randomized     (1:1) in two groups : early switch where treatment will be change to another anti-TNF, or     therapeutic intensification where interval between two injections will be shortened.     Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24     weeks. Principal outcome will be the variation of ASDAS between baseline and end of the     study. Number of patients to be included has been determined statistically from a preliminary     study (power >98% for ASDAS variation of 20% on week 24).      Expected results:      On week 24, we expect a better response and a greater proportion of patients in remission in     the early switch arm compare to the therapeutic intensification arm.   "
100406|NCT01971905|"     To investigate the ability of perfusion CT/US-scanning to facilitate recognition of different     tumour sub-types in small renal masses less than 7 cm by non-invasive imagining technology.   "
100407|NCT01971892|"     Acute respiratory failure may occur early in the postoperative course, requiring endotracheal     intubation and mechanical ventilation in selected patients, thus increasing morbidity and     mortality and prolonging intensive care unit (ICU) and hospital stay.We will perform a     multicenter, prospective, randomized clinical trial to compare the efficacy of non invasive     ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and     positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in the     treatment of postoperative acute respiratory failure. We also set out to examine the     hypothesis that early application of NIV may prevent intubation and mechanical ventilation in     patients who develop acute respiratory failure after abdominal surgery.   "
100408|NCT01971879|"     Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be     explored twice through a Cross-over strategy to determine whether remote preconditioning     improves arteritic patients' ability to walk.   "
100409|NCT01971866|"     This study aims to investigate the advantages of using AlignRT, a commercially available, FDA     approved camera-based imaging system for proton therapy patients prior to and during their     radiation treatment delivery.   "
100410|NCT01971853|"     All healthcare providers strive continually to improve the outcome of their treatment     approaches. The investigators hypothesize that preventive analgesics administered before a     child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.   "
105921|NCT01899625|"     This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability     and preliminary efficacy of an MI-based program for weight loss in young adults.   "
100414|NCT01971801|"     Urinary incontinence (UI) is a common disorder among older women that greatly affects quality     of life. Emerging evidence from observational studies links vitamin D insufficiency with UI.     Prior to a larger intervention trial of vitamin D among older women with low serum vitamin D     levels and urgency UI, we propose a pilot study in 100 older women comparing weekly, oral     vitamin D3 50,000 IU to placebo. We hypothesize that adequate vitamin D supplementation will     improve UI symptoms in older women with vitamin D deficiency. Changes in UI-episodes will be     assessed by a 7-day bladder diary and other validated symptom measures administered at     baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be     monitored. The expected outcomes will provide new knowledge regarding the impact of vitamin D     supplementation on UI symptom improvement and inform a larger, randomized controlled clinical     trial involving vitamin D supplementation.   "
100415|NCT01971788|"     Residual thrombosis of stent struts may occur after the end of primary angioplasty and     determine distal embolization and further myocardial damage. Bivalirudin is considered the     most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase     in stent thrombosis has been reported. In order to overcome this potential adverse event, a     prolonged infusion of bivalirudin after the end of PCI has been proposed.      This aim of this study is to test whether the use of long-term bivalirudin infusion, as     compared to the intra-procedural only administration, reduces residual thrombosis of stent     struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5     days follow-up.      A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by     TRansradial access site and AngioX study) study will be selected showing the following     inclusion criteria:        -  patients affected by STEMI undergoing primary PCI with stent implantation and randomised          to bivalirudin treatment,        -  patients who, in addition to the infarct related lesion, show at least one critical          stenosis of other coronary vessels suitable for staged-PCI,        -  patients whose anatomy is suitable for OCT evaluation.   "
100416|NCT01971775|"     Surgery is the first standard treatment for stomach cancer, but it still has negative factors     such as bleeding, leakage, closure, surgery part infection and cardiovascular and lung     complication by general anesthesia.      electric cautery is used extensively in surgery room due to the utility of simultaneous     severance and hemostasis. In some case, the electric current from vitality electrode may     unexpectedly stimulate or damage nearby muscles and nerves. Ultrasonically activated shears     (UAS) is a device to transform the protein of organ for organ incision or hemostasis. General     advantages possibly include shortened operating time, decrease of operative blood loss, and     relatively less damages to the normal organ. UAS is commonly used in the operation room,     which is now considered as a secure and useful medical device for for tissue dissection and     coagulation. Also, it is expected to lower the risk of surgery by reducing operating time and     blood loss.      However, clinical evidence is not sufficient for this device until now. Therefore, in this     study,        1. Evaluate the utility, efficacy, and safety of energy based device, in the case of open          gastrectomy        2. Would like to compare the following two kinds of energy based devices. A. For          conventional monopolar electrosurgery group : dissection and sealing will be conducted          by conventional monopolar electrocautery device B. For UAS group : dissection and          sealing will be conducted by UAS   "
100417|NCT01971762|"     Staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical     management and review of the clinical and molecular epidemiology.   "
100418|NCT01971749|"     Register of treatment of unprotected left main coronary artery stenosis in Andalucia     (RETRATO).   "
100419|NCT01971736|"     We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for     skin tightening immediately post laser and 3 months follow up.   "
100420|NCT01971723|"     It has been suggested that high amounts of total serum testosterone levels correlate with     higher lean body mass, lowered fat mass, greater muscle strength, and faster recovery. These     suggestions drive athletes and body builders to find ways to raise their testosterone levels.     Many athletes and bodybuilders look to alternative methods to anabolic steroids in order     increase their testosterone levels without legal repercussions or physiological side effects.     Herbs and other plant extracts have been introduced as a possible source to naturally boost     testosterone levels. Research supporting the use of herbs and plant extracts has been shown     to be equivocal. However, evidence in studies with hypogonadal men suggests that longjack     root may naturally boost testosterone levels.      Onnit Labs, LLC has packaged this supplement (T+) which claims it can naturally boost     testosterone and lower estrogen levels and subsequently improve performance. This product is     a powder (11g) that is mixed with 16 oz of water and consumed 20 minutes prior to anaerobic     workouts, such as high intensity weight training.      T+ is a multi-ingredient supplement that consists of vitamins B5 and B6, magnesium aspartic     acid, mucuna pruriens, longjack root, nettle root, red clover luteolin, resveratrol, beta-     alanine, branch chain amino acids, L- glutamine, Bioperine, and Fibersol 2.      The active ingredients purported to boost plasma testosterone levels are mucuna pruriens,     longjack root, and magnesium aspartic acid. The active ingredients claimed to lower plasma     estrogen concentrations are red clover, luteolin, resveratrol and nettle root. All other     ingredients (Branch Chain Amino Acids and Beta-Alanine) have been documented to improve     exercise performance.      It is hypothesized that there will not be any physiological changes after supplementation of     T+. It is also hypothesized that performance will not be affected by the supplementation of     T+.   "
100421|NCT01971710|"     The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is     to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH)     and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country     progress toward elimination of pediatric HIV/AIDS.   "
100422|NCT01971697|"     This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an     orthopaedic injury will be approached. If a patient consents to be part of the study, they     will complete a questionnaire. Participation in the study will end as soon as the     questionnaire is completed.   "
100423|NCT01971684|"     The purpose of this study is to understand physician treatment decisions in selecting     specific second line treatments in pediatric ITP and to determine the effectiveness of     different second line ITP treatments. Eligible patients are those ages 1-18 years who are     starting on a new second line treatment for ITP, defined as any treatment other than IVIG,     steroids, anti-D globulin, or aminocaproic acid. Enrolled patients remain on the study for     approximately one year.   "
100424|NCT01971671|"     To understand breast milk composition during different lactating stages.   "
100427|NCT01971632|"     The primary objective was to demonstrate the superiority of OXN over placebo over time from     the initial dose of study medication to multiple pain events (inadequate analgesia) during     the double blind phase.   "
100428|NCT01971619|"     To investigate the effect of vitamin D deficiency on the development of arrhythmia in     patients with acute myocardial infarction.   "
100429|NCT01971606|"     Periprocedural treatment with high-dose statins is known to have cardioprotective and     pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.      -Objective: to determine whether preoperative rosuvastatin loading is independently     associated with reduced myocardial ischemia and clinical outcomes in patients with stable     angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary     syndrome.      Study design        -  Prospective, double-blinded, single-center study of each 117 subjects enrolled        -  Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will          be enrolled preoperatively.        -  Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B)          Placebo (n=117).        -  The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a          total        -  All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be          compared at 30 days and 2 years postoperatively between two groups   "
100430|NCT01971593|"     Hypothesis:      By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the     great vessels with a prior atrial switch, and single ventricle Fontan patients, incident     heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias     decreased through decreases in myocardial fibrosis.      Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6     minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months     without therapy, after 6 months on therapy, then finally after 12 months of eplerenone     therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12     months on therapy. Patients will be randomly assigned to drug free period up front versus at     the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated     up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at     enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for     monitoring.   "
100431|NCT01971580|"     Hypothesis:      Patients with a Fontan type palliation are limited by preload, or the rate at which blood     returns to the heart after passively traversing the pulmonary capillary bed. By decreasing     pulmonary vascular resistance using an endothelin receptor antagonist, both ventricular     filling pressures and volumes will increase with a simultaneous decrease in systemic     impedance to flow and decrease in central venous pressures, leading to an improved capacity     to increase cardiac output, and thereby an improvement in patient functional status.      Patients who are candidates for the study will be randomized to a double-blind single     crossover study. Therapy with either ambrisentan or placebo will be continued for 12 weeks,     with a 2 week washout period between treatment periods. Subjects will be subjected to a VO2     max test to evaluate exercise capacity at enrolment, and on the last day of each treatment     period. As a component of the VO2 max testing the patient's VE, VCO2, VE/VCO2 slope,     ventilatory anaerobic threshold (VAT), peak work, efficiency, and other physiologic     parameters as typically obtained from cardiopulmonary testing will be assessed. In addition,     each patient will be asked to complete an SF-36 quality of life questionnaire at enrollment,     and on the last day of each study period.   "
100432|NCT01971567|"     The purpose of this study is to determine whether the addition of High-resolution,     relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve     insomnia symptoms based on changes in the Insomnia Severity Index at two months following     completion of the intervention, compared to placebo plus usual care.   "
100433|NCT01971554|"     This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)     of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in     this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic     agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary     hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a     dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction     from baseline is ≥34 mg/dL.   "
100434|NCT01971541|"     The proposed study is a randomized, controlled trial that will assess whether two group     interventions for PTSD - Mindfulness-Based Stress Reduction (MBSR) and Cognitive Processing     Therapy-Cognitive only (CPT-C) result in similar improvements in PTSD symptoms and     health-related quality of life (QOL). One hundred fifty-two Veterans with PTSD will be     randomized to MBSR (n = 76) or CPT-C (n = 76). Comprehensive assessments will take place     post-treatment and 3 months later.   "
100435|NCT01971528|"     Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past     research indicated that more than half of the individuals with PD demonstrated fatigue     symptom. The severity of fatigue was also correlated to the quality of life in individuals     with PD. Finding the contributions of the central and the peripheral factors to fatigue and     developing an effective training program for individuals with PD are very important.      Fatigue can be categorized into peripheral or central causes. The central fatigue and     voluntary activation failure originate from the decrease in motivation or the reduction of     the conduction within corticospinal tracts. Long term activation failure and central fatigue     will cause disuse of muscle and result in peripheral weakness and peripheral fatigue.     Quantifying the weighting of central versus peripheral factors contributing to the fatigue in     people with PD is important.      Most of the conventional strength and endurance training programs were based on the     researches of young groups. Almost no training program was design for enhancing the voluntary     activation level and relief the central fatigue. Seeking an appropriate training program to     enhance central activation is very important for individuals with PD who prone to fatigue.      Previous studies have shown that increasing afferent input by peripheral electrical     stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary     sensory cortex, the excitability of corticospinal tracts, and the functional performance in     young adults. Combining afferent input with strength training was more effective than     strength training along. ES, which is easy to quantify the dose of afferent input, is a     feasible method to provide such training.      The purpose of this project is to investigate the effects of the combination of ES at sensory     threshold and strength training on voluntary activation in the individuals with PD.   "
100436|NCT01971515|"     This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to     explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical     activity signals of MSC2363318A.   "
100437|NCT01971502|"     The objective of the single rising dose part (SRD) is to investigate safety, tolerability,     pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male     subjects. The objective of the food effect part (FE) is to investigate the relative     bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.   "
100449|NCT01971346|"     The purpose of this study is to determine the relationship between two types of cell signals     (type I IFN and TNF) in psoriatic skin prior to and during treatment with etanercept and     correlate that information with the degree of the improvement in the psoriasis.   "
102778|NCT01940874|"     Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to     decreased cerebral flow and oxygenation in individual patients and this can be detected by     means of cerebral oxymetry.   "
100438|NCT01971489|"     This phase I trial studies the side effects and the best doses of buparlisib, gemcitabine     hydrochloride, and cisplatin in treating patients with solid tumors that have spread to other     places in the body. Buparlisib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving buparlisib, gemcitabine hydrochloride,     and cisplatin may be a better treatment for solid tumors.   "
100439|NCT01971476|"     The present trial will be performed according to an open design to determine the maximum     tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in     paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than     18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy     (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric     cancer patients   "
100440|NCT01971463|"     This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral     blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke     within 96 hours of enrollment. The study intervention will be a one hour monitoring session.     There will be a 15 minute baseline measurement period, followed by intravenous administration     of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All     study measurements will cease after 1 hour. Subjects will be followed during their     hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse     events and to collect clinical information.   "
100441|NCT01971450|"     Local, prospective, multicenter, non-comparative, non-interventional, observational study. It     is planed to assess compliance of patients with PH (pulmonary hypertension) with the     physician's recommendation in real practice.   "
100442|NCT01971437|"     This is an ethically approved randomised controlled study looking at whether     Cystodistension(filling the bladder with fluid under pressure) provides any benefit over     cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine     samples will also be assessed for underlying infected cause of OAB using urinalysis,     microscopy and culture and cytokine assays (In collaboration with the University of Kent). We     hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and     the there is an increase prevalence in chronic urinary infections with raised cytokines in     women with refractory OAB.   "
100443|NCT01971424|"     Magnesium deficiency is associated also in the elderly with low physical performance;     nevertheless trials about the effect of supplementation of magnesium on physical performance     are not available in old people. The aim of our study is to investigate whether 12-weeks of     oral magnesium supplementation improves physical performance in healthy elderly women   "
100444|NCT01971411|"     In order to make bone health a reality for older adults, we need to consider the prevalence     of Vitamin D deficiency in relation to environment latitude as well as vitamin D     supplementation. Darker skin pigmentation and aging are known factors influencing the body's     ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document     vitamin D deficiency in elderly African American women living in a southern latitude.   "
100445|NCT01971398|"     This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome     in Russian children through development of printed FAS education materials targeting women of     childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The     rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not     precisely known. At this time, there are no programs to prevent FAS in Russia. The results of     our previous study, focus groups with health professionals, pregnant women and their     partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge     about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and     print resources related to this topic. Based on the initial findings, this proposal aims to     develop and evaluate in a clinical trial informational brochures for women to increase     knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested     are:        -  1. Compared to the control group (CG) of women who receive a standard locally available          flyer with health recommendations, women in the experimental groups who are exposed to          printed information on FAS will show significantly more knowledge about FAS,          significantly less acceptance of any alcohol use during pregnancy, and reduced drinking          at one month follow-up assessment.        -  2. The group exposed to a brochure with negative images (IGN - Intervention group with a          negative brochure) regarding drinking during pregnancy will show significantly greater          change in the predicted directions compared to the group exposed to positive images (IGP          - Intervention group with a positive brochure) at the one month follow-up assessment.   "
100446|NCT01971385|"     Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE     or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid     or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized     with placebo solution will receive placebo solution on their cold sore within 72 hours of a     recurrence. Subjects will be followed for up to 6 mos after application of study medication.   "
100447|NCT01971372|"     Specific Aim 1: To identify differences in pain perception and satisfaction with pain control     in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory (NSAIDS)     postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac. Specific     Aim 2: To compare the differences in narcotic usage and medication side effects.   "
100448|NCT01971359|"     This study is determining the clinical outcomes, based on neurological testing, for the     parafascicular minimally invasive clot evacuation technique. We will collect data from the     time of surgery up until 90 days post procedure. We will also be looking at financial data as     well.        -  H(0): there is no economic benefit to the system with early surgical intervention for          ICH        -  Alternative Hypothesis:H(1) Assuming clinical equipoise, i.e., no benefit in clinical          outcome with early surgical intervention (null hypotheses) H(0) is correct), the ability          to accelerate the patients care from the entry point to the exit point will result in a          significant economic advantage to the system through cost reduction.   "
105999|NCT01898598|"     This randomized, double-blind, placebo-controlled study will assess the efficacy and safety     of vismodegib with surgery in participants with basal cell carcinoma.   "
100450|NCT01971333|"     The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload     variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g.     stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It     is not yet clear that dynamic preload parameters based on which mechanism will be accurate to     predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to     claried which dynamic preload parameters would be more accurate during the liver     transplantation.   "
100451|NCT01971320|"     Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration     pneumonia and denutrition. It could be present in the majority of central neurological     disease (degenerative or vascular disease), which explains that it is the first case of     mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate     that sensitive transcutaneous electrical stimulation could improve swallowing coordination     and reduce aspirations. This technique could be used at home.      The aim of this study is to demonstrate that sensitive electrical stimulation could improve     oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in     seven centers. Sensitive electrical stimulation will be applied either as active stimulation,     either as a placebo. Active electrical stimulation will be realised at 80 hz during 30     minutes, under motor threshold and above sensitive threshold. It will be administrated via     surface electrodes over the hyoid bone. Patients will be separated by randomisation.      Patients will be evaluated before and after 6 weeks of use. Methods will evaluation     questionnaire, clinical examination and videofluoroscopy. The time of use will also be     collected.      We wish to demonstrate that transcutaneous electrical stimulation is able to improve     oropharyngeal dysphagia in stroke.   "
100452|NCT01971307|"     Although effective treatments for psychosocial symptoms and disorders are available, patients     frequently do not receive the most appropriate and effective treatment for their symptoms     because of inappropriate and unstructured diagnostics of psychosocial symptoms in general     practice. The hypothesis is that by using the intervention SGE-PsyScan the clinical symptoms     of patients can be assessed more uniformly and earlier as opposed to the GPs' assessment in     usual care. As a result, patients are supposed to start earlier with a treatment that fits     the type and severity of their symptoms better.      The patients will be randomly assigned to either receive the SGE-PsyScan or usual care.   "
100453|NCT01971294|"     Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint     stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or     pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as     narcotic medication use, puts patients at higher risk of secondary bladder filling and     voiding dysfunction. In another hand, few case report and small sample observational studies     have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more     frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one     (lcSSc). But prevalence or incidence is unknown.      Urinary symptoms are seldom reported by those suffering from them and are rarely part of a     systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be     of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore     urinary tract involvement might predispose to urinary tract infection due to flow limitation     and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive     form of disease conferring a greater loss of physical function, higher risk for hospital     admission and death.      Thus, identifying urinary symptoms would permit to address specific rehabilitation or     medication therapy, in order to minimize the consequences of the bothersome symptoms and     identify those subjects at higher risk of urinary infection, aggressive disease/loss of     function or death.      This study will also give basement to build an interventional study directed toward LUTS     treatment in this population.      In this prospective cohort we would like to:        -  Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited          forms of systemic sclerosis.        -  Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS          among patients suffering from systemic sclerosis.        -  Evaluate the impact of LUTS symptoms on Quality of life.        -  Compare the discrimination ability of Cochin-hand score and HAQ score to predict          incontinence in this population.        -  Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract          infection, mortality and loss of autonomy.   "
100454|NCT01971281|"     The study is a prospective, double arm, non-randomized, open label pilot trial, designed to     study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L     concomitant with gemcitabine or concomitant with gemcitabine plus nab-paclitaxel, for     front-line therapy of pancreatic adenocarcinoma. The device is an experimental, portable,     battery operated device for chronic administration of alternating electric fields (termed     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated     electrode arrays.   "
100455|NCT01971268|"     In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch     concept compared to the use of platform-matched concept, refrain marginal bone loss during     osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement     of the final restoration = at 18 weeks=T2)   "
100456|NCT01971255|"     Background:      - Researchers want to know if a certain type of antibody in the blood affects whether people     get influenza (the flu). They will study 2 different groups with different levels of anti-HA     antibodies and expose them to the flu virus. They will study how the flu develops in a     healthy person. This may lead to future studies to develop new vaccines and treatments for     the flu.      Objective:      - To study how people can be protected from flu infection.      Eligibility:      - Healthy volunteers 18 to 50 years of age.      Design:        -  Participants will be screened through the use of a medical history, physical exam, and          laboratory tests.        -  Groups of 7 participants will stay in an isolation unit in a hospital for at least 9          days with no visitors.        -  Participants will be screened again upon admission. They will also have:        -  ECG: soft electrodes will be stuck to the skin. A machine will record the heart s          electrical signals.        -  Echocardiogram: a small probe will be held to the chest to take pictures of the heart.        -  Lung tests: participants will blow into a machine.        -  They will also have nasal fluid collected. This will be done either with a swab or with          a tube of water washing out the nose. This will be done once every day.        -  The flu virus will be sprayed into the participant s nose. This will be done only once.        -  Participants will complete a questionnaire on day 1 and twice a day after that for 14          days.        -  A medical team will watch participants 24 hours a day. They will go home after 2 days of          negative flu tests.        -  Participants will have 4 follow-up visits over 8 weeks.   "
100606|NCT01969279|"     Although there is strong evidence that bisphosphonates prevent certain types of osteoporotic     fractures, there are concerns that these medications may be associated with rare atypical     femoral fractures (AFF). But the relationship between long-term bisphosphonate treatment and     AFF is unclear. In this study, the investigators would like to analyze the long term effects     on femur by bisphosphonate treatment.The participants are treated in the investigators     hospital more than four years.   "
100457|NCT01971242|"     This study is a clinical trial in patients with Parkinson's disease, of a drug called     Exenatide which is already licensed for the treatment of patients with Type 2 Diabetes. There     have been several groups that have confirmed that Exenatide has beneficial effects on nerve     cells when tested in the laboratory, that raises the possibility that Exenatide may slow down     or stop the degenerative process of Parkinson's disease. In an open label trial in patients     with Parkinson's disease who self administered the drug for 1 year, we have previously shown     that the drug is well tolerated and shows encouraging effects on the movement and     non-movement aspects of the disease, even 2 months after patients stopped administering the     drug. The next step is therefore to formally evaluate whether Exenatide really is a potential     neuroprotective drug, i.e. stops the nerve cells dying in Parkinson's disease, by     conducting a double blind, placebo controlled trial.   "
100458|NCT01971229|"     Surgery is a stress on the body and recovering well after surgery is very important to     patients and their doctors. It is therefore important to prepare patient's bodies for the     stress of surgery, and one way to do this is to provide proper nutrition. In the past,     patients were asked to prepare for surgery by fasting from midnight before surgery. Today, it     is known that this practice is not beneficial to patient's recovery. In fact, it has been     recognized that drinking a sugary beverage (e.g., juice) before surgery stimulates the     production of insulin, which is a hormone that helps make the proteins needed for wound     healing after surgery. This is currently practiced at the MUHC. It might also be beneficial,     however, to drink a beverage that contains sugar and whey proteins (a protein isolated from     milk) before surgery. In fact, whey proteins stimulate insulin and may also have the added     benefit of improving muscular strength. In this study, investigators will measure the level     of insulin produced after drinking a carbohydrate (i.e., sugar)-whey protein beverage to     determine how it compares to the level of insulin produced after drinking the sugary beverage     used at the MUHC.   "
100459|NCT01971216|"     Primary hypotheses      1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week     2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a     higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects     on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more     optimal growth, specifically higher lean mass and lower fat mass (body composition)      Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy     intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk     (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and     hence infant growth and body composition.   "
100460|NCT01971203|"     The primary objective of the study is to determine whether quetiapine extended-release in     combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo     in treating depressive and anxiety symptoms in patients with both major depression and     generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly     assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about     45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which     medication will be discussed. Both clinician administered and self-report measures will be     used to compare groups before and after 16 weeks.   "
100461|NCT01971190|"     Central serous chorioretinopathy (CSC) is a self-limiting disease that usually associated     with good visual prognosis. In some cases, however, CSC may persist and result in permanent     retinal or retinal pigment epithelium (RPE) damage. Therefore, if the disease is persistent     beyond the acute phase, an active treatment should be considered to prevent an irreversible     damage to retinal function.      The pathophysiology of CSC is associated with abnormal choroidal circulation. Indocyanine     green angiography (ICGA) has revealed dilated and congested choroidal vessel and leakage into     the extracellular space that appears as area of hyperfluorescence seen in middle and late     phase in eyes with CSC.      A goal of treatment has been focused on reducing choroidal hyperpermeability. Currently,     photodynamic therapy with verteporfin (PDT) and intravitreal anti-VEGF (vascular endothelial     growth factor)antibody injection are being tried in order to treat chronic CSC. PDT reduces     choroidal hyperpermeability by inducing hypoperfusion of the choriocapillaris in the short     term and choroidal vascular remodeling over time. Intravitreal anti-VEGF injection for the     treatment of CSC also effectively reduces choroidal hyperpermeability by blocking vascular     leakage. Both methods have shown to be effective with good functional outcome for treating     chronic CSC in many reports, but until now there is no established standard treatment     protocol for chronic CSC.      Bevacizumab (Avastin) and ranibizumab (Lucentis) have been used widely as anti-VEGF     therapeutic agent for the treatment of age related macular generation (AMD) and macular edema     of various reasons. A newly developed anti-VEGF drug, aflibercept (Eylea○R), shows higher     affinity to VEGF and has a longer duration of effect in the vitreous.FDA approved aflibercept     to treat wet type AMD and macular edema due to central retinal vein occlusion.      Until now, no study has been reported on the efficacy and safety of aflibercept for treating     CSC. The aim of this study is to evaluate the efficacy and safety of intravitreal aflibercept     injection for the treatment of idiopathic CSC   "
100462|NCT01971177|"     This clinical study is a randomized, controlled, open, prospective, multi-centre,     multi-surgeon post-market-clinical-follow-up study to investigate the impact of cataract     grade on the efficacy and safety of femtosecond laser assisted lens fragmentation to support     phacoemulsification of the cataractous lens prior to intraocular lens (IOL) implantation.   "
100463|NCT01971164|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),     and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days     in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.   "
100472|NCT01971047|"     The purpose of this study is to compare the safety and efficacy of intravenous (IV)     administration of FDA approved regular human insulin and subcutaneous (SC) administration of     humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia     (high blood sugar) during the immediate preoperative period in patients with diabetes having     outpatient surgery at the Emory Ambulatory Surgical Center (ASC).      In this randomized controlled clinical trial patients with diabetes will be administered     corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to     determine whether SC humalog results in improved intra and post-operative blood sugar     control.The most common current practice at Emory University in the ambulatory surgical     setting is IV administration of regular insulin for treatment of pre-operative hyperglycemia.     Subjects will not be paid for their participation and will be assured of treatment for their     hyperglycemia regardless of study participation.   "
100607|NCT01969266|"     The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of     PCI-32765 (ibrutinib) in healthy adult volunteers.   "
101910|NCT01952197|"     1. Hypothesis The early elevation of the lower extremities during out-of-hospital     cardiopulmonary resuscitation increases survival to one month by improving cardiac preload     and blood flow to the heart and brain during chest compression.   "
100464|NCT01971151|"     RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining     factor of chronic low back pain- while increasing level of daily functioning, despite the     pain. This is done by exposing patients to their most feared activities/movements, while     behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs     about pain. Yet, performing exposure exercises might be very threatening for patients and     might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking     behavior should be allowed or not during therapy is heavily debated. Whereas some argue that     it will only interfere with therapeutic progress because it prevents the disconfirming     experience exposure tries to offer, other argue that it will facilitate therapeutic progress     because it enhances one's sense of control, if used judiciously. So far     (clinical-)experimental studies have provided mixed evidence nor have they lead to any     clinical recommendation. Hence, in a replicated single-case experiment, we will compare     exposure therapy with versus exposure without safety-seeking behavior versus exposure only.      STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who     fulfill all inclusion and exclusion criteria and participate voluntarily.      INTERVENTION: All participants receive exposure therapy at the rehabilitation department of     the academic hospital in Maastricht, but with different recommendations for the use of     safety-seeking behavior.      We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of     goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing,     pain solutions, need to control and safety-seeking behavior. To measure to the influence of     safety-seeking behavior on actual level of functioning, two behavioral performance tasks will     also be presented, ie. a bag carrying task and a personalized task.      BURDEN AND RISKS: There are no risks associated with participation to this study that are not     otherwise related to rehabilitation and movement in general and participation is completely     voluntary. Participants are requested to fill out questionnaires on a daily basis at home     (computerized if possible), as well as on different time points during the study and at     follow up and perform two behavioral performance tasks. This study could help to further     improve the beneficial long-term effects of exposure.   "
100465|NCT01971138|"     This study explores the routines of registration of surgical site infections (SSI) at     different surgical centers in Sweden. It explores the sensitivity and specificity of the     registration routines of SSI are at Halmstad County Hospital, Sweden.   "
100466|NCT01971125|"     The purpose of this study is to evaluate the prevalence, during the enrolment, of Left     Ventricular Dysfunction diastolic and/or systolic in patients with diabetes mellitus type 2     without known or documented heart disease history and recognize its predictive clinical,     biohumoral and with non-invasive techniques parameters.   "
100467|NCT01971112|"     Poor Ecuadorian older people suffer from chronic dietary deficiencies of zinc, iron, copper,     vitamins C, B6, B12, D, and folic acid. The investigators have previously shown that these     deficiencies are associated with impaired immune function and increased incidence of     respiratory infections (RI). The hypothesis is that correction of these specific nutrient     deficiencies will improve immune response and thereby enhance resistance to respiratory     infections. To test this hypothesis this study will evaluate the effect of supplementation     with specific vitamins and minerals found to be deficient in poor elderly Ecuadorians on     markers of immune function and the incidence of RI. A randomized, double-blind,     placebo-controlled trial in 320 older people (≥65 y)will be carried out in Quito, Ecuador.     Participants will receive multivitamin and mineral supplements or placebo tablets daily for     12 months. Nutrients will be provided at US Recommended Daily Allowance (RDA) levels, except     for vitamin C and zinc doses, which will be 5 times and 1.25 times higher than the RDA,     respectively. Incidence of respiratory infections (the primary outcome) will be assessed     weekly by field nurses and physicians from the study team. Secondary outcomes include     delayed-type hypersensitivity (DTH) skin test, cathelicidin production by mucosa respiratory     cells, and serum C-reactive protein (CRP) as measures of immune function. Blood micronutrient     levels and haemoglobin status will be collected as measures of adherence to the trial     regimen. Incidence rate of RI and rate ratio (RR) will be calculated to quantify the effect     of the intervention on the incidence of respiratory infection. This will be the first trial     of its kind conducted specifically in a population of older people known to have poor     micronutrient status. The findings of the study may be important for similar populations in     other low- and middle-income countries.   "
100468|NCT01971099|"     Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in     society and is strongly linked to the quality of life of women. The androgen hormones decline     over age in the premenopausal period, which occurs around 20 years. Tribulus terrestris is a     plant native to India, recommended in the treatment of infertility, low libido and impotence.     Its main active ingredient is the protodioscin, which has been attributed to an increase in     testosterone levels and improved sexual function. The aim of this study is to evaluate the     effects of Tribulus Terrestris in premenopausal women with HSDD.   "
100469|NCT01971086|"     Multi-centre, open-label, prospective, uncontrolled, single-arm, non-interventional study     (NIS) with objective to collect and evaluate data concerning treatment with Rhinospray Plus     in everyday curative routine treatment of acute rhinitis   "
100470|NCT01971073|"     A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive     suppression is the ability to control or suppress irrelevant responses and to adopt relevant     responses instead. The purpose of this study is to investigate the effects of transcranial     direct current stimulation (tDCS) on information suppression in schizophrenic patients. This     is a noninvasive technique of brain stimulation that induces prolonged functional changes in     the cerebral cortex through the application of a weak direct current to the scalp (Nitsche &     Paulus, 2001). The aim of this study is to test whether bilateral tDCS over the dorsolateral     prefrontal cortex (DLPFC) differentially modify performance on several cognitive tasks.   "
100471|NCT01971060|"     Premenopausal Women ages 18-42 will undergo a laparoscopic myomectomy. Prior to the     myomectomy, adhesions will be assessed using a modified AFS scoring technique. All     investigators will provide usual and customary care to research subjects during the first     look laparoscopy. This includes the use of all standard practice anti-adhesive agents and     heparinized irrigation fluids.V-Loc 180 suture will be utilized in all patients. All patients     will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the     initial surgery and reevaluated via modified American Fertility Society scoring techniques.     An independent reviewer will also score adhesions utilize a video recording made from the     second look laparoscopic surgery. Patients will be contacted both 1 and 4 weeks post -op and     assessed for complications. It is the expectation that patients will show no greater     post-operative adhesion formation and a <1% complication rate. Time and ease of suturing will     also be evaluated. It is expected that the V-Loc suturing technique will show significantly     reduced suturing time, be easier to use, and will be associated with minimal adhesions.   "
100486|NCT01970852|"     The aim of this study is to evaluate the impact of an inpatient personal health record (PHR)     portal intervention within the hospital environment. The intervention hopes to improve     patient engagement with their care and to measure patient activation and satisfaction.     Additional clinical measure (e.g. number of adverse events that occur during the stay,     changes to medication orders, etc.) will also be studied. Characterization of hospital     patient and clinician attitudes towards patient engagement will also be formalized.   "
100657|NCT01968616|"     In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment     have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for     visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological     features by SD-OCT.   "
100473|NCT01971034|"     In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an     uncommon disease, however very aggressive.Only 20% of cases are indicated for curative     surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic     disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first     line, with survival around 6 months approximately.There is no standard treatment regimen for     second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin     is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing     number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma,     probably due to the effect of anti-insulin growth factor (IGF-1). This study will add     metformin to standard treatment for second line of locally advanced or metastatic pancreatic     adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate     whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical     and radiological evaluation.   "
100474|NCT01971021|"     As of today there is very limited scientific knowledge in whicj of the two vascular access     devices (PICC-line or venous ports) that offers the lowest complicationrates in     cancerpatients. The study group wants to clearify this unsolved matter by comparing the two     systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are     also looking at all catheter related complications and patient satisfaction.   "
100475|NCT01971008|"     The purpose of the present study is to determine whether the use of an abdominal binder is     effective in the non-pharmacological management of orthostatic hypotension in patients     suffering from Parkinson's disease   "
100476|NCT01970995|"     The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS     2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by     Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure     for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers     continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and     smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to     provide context to the exposure reduction.   "
100477|NCT01970982|"     The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating     System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the     levels of biomarkers of exposure for selected harmful and potentially harmful constituents     (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).   "
100478|NCT01970969|"     Our primary hypothesis is that a risk score comprised of approximately 10 single nucleotide     polymorphisms (SNPs) that are associated with atrial fibrillation at the Genome Wide     Association Study (GWAS) level is associated with the development of atrial fibrillation     among previously undiagnosed patients at high risk for atrial fibrillation. A current example     of these SNPs is shown in Table 1. As a secondary hypothesis, we will test the association     between atrial fibrillation diagnosed in this study with a subset of SNPs reported to be     associated with atrial fibrillation and with fine-mapping SNPs. We will also test the     association between atrial fibrillation of less than and greater than 30 seconds and a panel     of approximately 10 SNPs.   "
100479|NCT01970943|"     The placebo effect is a phenomenon that has experienced major advances of its understanding     in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have     yet to be compared to healthy subjects. The investigators study aims to investigate the     magnitude of placebo response and related opioid release in patients that suffer from     episodic migraines as compared to healthy controls. In particular, the investigators are     looking to map brain activity during placebo analgesia using modern brain imaging techniques     such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET).     The investigators hypothesis is that placebo response and the availability of opioid     receptors is reduced in chronic migraine patients.   "
100480|NCT01970930|"     The purpose of the study is to isolate and characterize stem cells of patients with     Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are not     working the way they should be and why they seem to be sensitive to regulatory factors in the     blood, such as clotting.   "
100481|NCT01970917|"     Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population.     Despite many treatment approaches, instillation of topical lubricants remains the mainstay of     therapy. However, most of the topical lubricants available are not very well characterized     and data about efficacy is sparse.      The aim of the present project is to investigate the effect of topically administered Olixia     pure® eye drops on tear film thickness in healthy subjects.      Tear film thickness will be determined using ultra high-resolution optical coherence     tomography (OCT). Measurements will be performed before instillation of the eye drops and     every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye     drops, the fellow eye will receive physiologic saline solution as placebo control. The study     eye will be chosen randomly.   "
100482|NCT01970904|"     This study will explore the relationship of different DEB025 doses in combination with RBV to     pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic     hepatitis C GT 2 and 3 treatment naïve patients.   "
100483|NCT01970891|"     Potential for electrical stimulation to relieve Freezing of Gait (FOG)   "
100484|NCT01970878|"     This is a multi-center, randomized, double-blind, parallel group, chronic dosing,     active-controlled, 28-week safety extension study of the two pivotal 24-week safety and     efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the     long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF)     combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to     very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included     as an active control. To be eligible for this study, a subject must complete participation in     Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).   "
100485|NCT01970865|"     Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported     outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients     and ROS1+ advanced non small cell lung cancer patients .   "
100515|NCT01970475|"     The purpose of this study is to compare the effectiveness and safety of ABP 501 against     adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an     inadequate response to methotrexate (MTX).   "
100487|NCT01970839|"     There are a number of risk factors for development of chronic pain that have been evaluated     including age, gender, type and duration of surgery, duration of pain prior to surgery and     tourniquet application. There is some scientific evidence from animal studies demonstrating     that prolonged tourniquet application can result in lack of oxygen supply to nerves, and     subsequent nerve damage resulting in chronic pain. This theory has not been proven in humans.     In this study the investigators will indirectly assess the evidence for abnormalities caused     by tourniquet application on subjects' nerves using well established devices to determine the     function of these nerves.   "
100488|NCT01970826|"     In patients that require dental implants , does performing the surgery in clean sterile field     compared to aseptic field, produces more post-operatory complications, implant morbidity or     patient discomfort ?   "
100489|NCT01970813|"     The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture     (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and     investigate whether there is sustainability of treatments effects by follow-up assessments     after the end of the treatment.   "
100490|NCT01970800|"     The purpose of the study is to evaluate the predictive value of IGF-1 generation test for     growth velocity during GH treatment for 12 months.   "
100491|NCT01970787|"     This is a Single-center prospective pilot trial involving up to 22 subjects. This study will     assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal     canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in     HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention     will demonstrate that a reasonable proportion of subjects will be histologically cleared of     their anal HSIL within the ETZ in a tolerable and relatively safe manner   "
100492|NCT01970774|"     This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx)     testing as part of a standard medication therapy management (MTM) session for patients taking     multiple medications, a high-risk population for adverse drug reactions and non-response.     Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM     plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis     will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical     outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are     minimal with the primary risks being associated with loss of confidentiality, typical     discomfort associated with acquiring blood samples, and genetic discrimination.   "
100493|NCT01970761|"     Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic     pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar     quality, but scantly study has explored its effects on pain. The aim of the study was to     survey its effect on pain.   "
100494|NCT01970748|"     Randomized comparison within the endoscopic esophageal varices ligation versus non-selective     beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.   "
100495|NCT01970735|"     The aim of the study was to compare the severity of illness between groups of patients     (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).      Despite advances in research on the subject, answers are still needed on these diseases.      We also aim to determine whether the chromosomal genetic abnormality is involved in other     diseases and the frequency of this mutation in the population of patients FSHD.      This study will increase our knowledge of the two forms of FSHD who present a common     pathophysiological mechanism and may occur together in the same family with a worsening of     the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1     and type 2 seems to have clinical consequences requiring appropriate management   "
100496|NCT01970722|"     This clinical trial studies the side effects and how well surgery and heated chemotherapy     with or without non-heated chemotherapy after surgery works in treating patients with     ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy     into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or     peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated     chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.   "
100497|NCT01970709|"     This multicenter Registry is to assess whether the use of pharmacogenomic data results in a     meaningful change in a subject's drug or dose regimen. In addition, the Registry will     evaluate the relationship between adverse drug reactions (ADR) and genotype and assess     resource utilization (emergency department visits and hospitalizations) associated with ADR.   "
100498|NCT01970696|"     Rare tumors are understudied, yet have the potential to shed light on vast areas of cancer     research. Ovarian sex cord-stromal tumors, rare tumors of childhood and young adulthood, have     recently been found to be associated with a lung cancer of early childhood called     pleuropulmonary blastoma (PPB). The cause of these ovarian tumors is unknown. DICER1     mutations are seen in the majority of children with PPB. Research shows DICER1 mutations are     also seen in some patients with ovarian tumors. Like PPB, ovarian stromal tumors are highly     curable when found in early stage; however, later forms of the disease are aggressive and     often fatal. The International Ovarian Stromal Tumor Registry collects clinical and biologic     data to understand why these tumors occur and how to treat them. Current work involves the     study of the role of DICER1 and miRNA expression in ovarian stromal tumors. Understanding the     clinical history, predisposing factors and DICER1 and miRNA expression in these ovarian     tumors of childhood will lead to targeted screening and risk stratification for     evidence-based treatment and biologically rational therapies. These efforts will improve the     lives of children by increasing survival and reducing late effects.      The specific goals of the International Ovarian and Testicular Stromal Tumor Registry are:        1. to understand risk factors by studying age, pathologic subtype, histopathologic          features, tumor invasiveness, degree of differentiation, presence of metastasis        2. to collect information on personal and family history in order to refine the clinical          characteristics of patients and families with and without germline DICER1 mutations and          other genetic predisposing factors        3. to determine whether there is a pattern of gene expression or DNA alterations that          correlate with predisposition to ovarian tumors, biologic behavior and clinical outcome        4. to determine optimal screening regimens        5. to use clinical data obtained through the Registry to refine treatment algorithms        6. to establish a collection of annotated biology specimens (tumor tissue and germline DNA)          for future research   "
100499|NCT01970683|"     The study will investigate whether probiotics given just before and shortly after major     abdominal operation improve outcomes.   "
100500|NCT01970670|"     The primary objective is to determine how accurately one can estimate the size of the index     tumor on preoperative imaging in patients with known breast cancer, using pathology as a     reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the     maximum diameter (mm) of the index tumor.   "
100658|NCT01968603|"     The aim of the study was to describe postoperative weight change in adults undergoing surgery     for craniopharyngioma and identify preoperative factors associated with it.   "
100501|NCT01970657|"     This observational safety follow-up study enrolled subjects from the 802-247-09-032 study     with the investigational product HP802-247 for venous leg ulcers, who received at least one     application of HP802-247 or Vehicle (Placebo). This study is being done for the following     purposes:        1. to identify new adverse events,        2. to examine ongoing adverse events not resolved in subjects who participated in the          802-247-09-032 trial,        3. to record wound status, and        4. to determine if there are differences in Health Related Quality of Life (HRQoL)          associated with the treatment assignment from the 802-247-09-032 Trial.      About 440 subjects were to participate depending upon subject enrollment from the previous     study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.   "
100502|NCT01970644|"     Cancer which spreads to the brain (brain metastases) is a common and significant problem.     Historically, whole-brain radiotherapy has been used to treat these patients but has a     negative effect on cognition. Radiosurgery is an alternative treatment with potential for     fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of     patients with multiple brain metastases is not well studied. We propose a pilot study at the     Winnipeg Centre for Gamma Knife Surgery to examine this issue.   "
100503|NCT01970631|"     The objectives of this research are to conduct a proof of concept randomized controlled trial     with 200 patients undergoing primary total knee replacement (TKR) at Brigham and Women's     Hospital (BWH). The trial will compare levels of physical activity in subjects in the     behavioral and economic interventions versus Usual Care post TKR.   "
100504|NCT01970618|"     RV1162 is a new medicine being developed for possible treatment of smoking related lung     disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of     this study is to investigate the safety, tolerability and pharmacokinetics of single and     repeat doses of RV1162.   "
100505|NCT01970605|"     This web based e-Registry will be international, multi-center and prospective. Silver Graft     e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient     population   "
100506|NCT01970592|"     Hemiparesis, strictly defined as (muscular) weakness affecting one side of the body, is seen     in three-quarters of individuals following stroke. Weakness in this population results from     both neural and muscular factors which include, respectively, the ability to activate     skeletal muscle as well as the force generating capacity of the muscle. The overall goal is     to improve walking in persons post-stroke by training subjects with an intervention that     specifically targets existing neural and muscular impairments, thereby facilitating locomotor     recovery.   "
100507|NCT01970579|"     The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon     catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral     artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm &     ≤ 7mm and lesion lengths ≥ 4 cm & ≤ 27 cm. It is the intention of this trial to treat     suitable target lesions with DCB only.   "
100508|NCT01970566|"     Obesity is a prevalent disorder and linked with inflammation, insulin resistance,     dyslipidemia, obstructive sleep apnea, atherosclerosis, and associated with significant     morbidity and mortality. This randomized clinical trial will compare the effectiveness of     Intense Exercise/Moderate Calorie Restriction (IE-MCR), Topiramate-Phentermine (TP) and     cognitive behavioral therapy (CBT) on obesity and atherosclerosis in individuals with     morbidly obesity. This randomized clinical trial will compare: 1) the change in fat mass and     atherosclerosis, 2) the change in psychological and quality-of-life as well as economic     burden in response to IE-MCR, TP and CBT, and 3) conduct exploratory mechanistic     biomolecular, genetic and therapeutic analyses to develop intervention-specific     individualized intervention models to improve management of morbidly obese individuals.   "
100509|NCT01970553|"     Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination     with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to     determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in     combination with gemcitabine, to characterize the safety profile and feasibility of this     combination in patients with selected advanced solid tumors, to characterize the     pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity     in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics     (PGx) in tumor samples of patients exposed, in order to assess potential markers of response     and/or resistance.   "
100510|NCT01970540|"     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination     with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid     Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183     in combination with doxorubicin, to characterize the safety profile and feasibility of this     combination, to characterize the pharmacokinetics (PK) of this combination, to obtain     preliminary information on the clinical antitumor activity,to explore the feasibility, safety     and efficacy of a potential improvable dose of this combination in selected tumor types [i.e.     small cell lung cancer (SCLC) and endometrial cáncer] and to evaluate the pharmacogenomics     (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to     assess potential markers of response and/or resistance.   "
100511|NCT01970527|"     This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in     treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able     to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal     antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor     cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.   "
100512|NCT01970514|"     To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess     preliminary cost/benefit analysis in patients undergoing decompression surgery for     symptomatic lumbar disc herniations.      The general hypothesis is that the ARO significantly improves outcomes in patients undergoing     decompression surgery for symptomatic lumbar disc herniations.   "
100513|NCT01970501|"     This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to     metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial     flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic     receptor.   "
100514|NCT01970488|"     The purpose of this research study is to compare the efficacy and safety of ABP 501 and     adalimumab (HUMIRA®) in adults with plaque psoriasis.   "
100516|NCT01970462|"     This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in     patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will     receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient     population due to the effects on hepatic glucose production (a major feature of SH), safety     (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and     tolerability. The secondary objective of this study is to determine whether the management of     patients with persistent insulin requirements following cardiac surgery differs among     patients with stress hyperglycemia or mild diabetes.   "
100517|NCT01970449|"     The purpose of this study is to test the safety and immune response to three different sets     of HIV vaccines in healthy, HIV-uninfected adults.   "
100518|NCT01970436|"     Not all pregnant women have the same risks for pregnancy complications. Women at low-risk for     pregnancy complications may not need the same type of prenatal care. The goal of this study     is to learn about the use of telemedicine for low-risk pregnant women and improve the     delivery of prenatal care. Telemedicine is medical care provided using a computer or     telephone to visit with a doctor for some medical appointments. Participating patients will     be assigned by a computer to either standard prenatal care, or prenatal care involving a     combination of standard prenatal visits and telemedicine visits. Both groups will have the     same number of prenatal care visits.      In both groups, we will ask about the patients' satisfaction with their care, the amount of     time they spent visiting with their doctor, and information about time and their expenses. In     the telemedicine group, we will teach how to measure blood pressure, fetal heart rate, and     weight from home.      The goals of this study are to: 1) assess the patient satisfaction, patient experiences and     preferences, financial impact, clinical outcomes, and provider satisfaction of providing     personalized prenatal care for low-risk pregnancies using telecommunication and remote     patient care devices; and 2) measure the reliability of at-home, patient-recorded,     computer-documented prenatal care measurements. The primary outcome is patient satisfaction     with prenatal care after delivery.   "
100519|NCT01970423|"     Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective     randomized study so far demonstrating such an effect in patients with conventional pacemaker     undergoing upgrading to CRT because of heart failure.   "
100520|NCT01970410|"     The purpose of this study is to determine if teriflunomide will be safe and effective to     prevent relapses in patients with relapsing types of MS when switching from natalizumab to     teriflunomide in patients at risk for PML. This is a two center interventional study of     patients who have had 12 or more continuous infusions of natalizumab , who are anti-JCV-ab     positive, and who had been free of clinical relapses during prior 12 months of natalizumab     therapy who will be switching to teriflunomide.   "
100521|NCT01970397|"     A prospective, randomized, controlled, multi-center study of the safety and effectiveness of     JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines   "
100522|NCT01970384|"     The purpose of this study is to evaluate whether transcranial direct current stimulation of     the cerebral swallow motor cortex in addition to standard care can enhance recovery of     swallow function in acute dysphagic stroke patients compared to sham treatment plus standard     care.   "
100523|NCT01970371|"     This is a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1)     comparing the efficacy and safety of plazomicin with colistin when combined with a second     antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream     infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated     bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP, VABP,     cUTI, or AP due to CRE, not eligible for inclusion in the other cohort, will be enrolled into     a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic drug     management (TDM) will be used to help ensure that plazomicin exposures lie within an     acceptable range of the target mean steady-state area under the curve (AUC).   "
100524|NCT01970358|"     This research study is evaluating a new type of melanoma vaccine called Personalized     NeoAntigen Cancer Vaccine. The purpose of this study is to determine if it is possible to     make and administer safely a vaccine against melanoma by using information gained from     specific characteristics of the participant's own melanoma. It is known that melanomas have     mutations (changes in genetic material) that are specific to an individual patient and tumor.     These mutations can cause the tumor cells to produce proteins that appear very different from     the body's own cells. It is possible that these proteins used in a vaccine may induce strong     immune responses, which may help the participant's body fight any tumor cells that could     cause the melanoma to come back in the future. The study will examine the safety of the     vaccine when given at several different time points and will examine the participant's blood     cells for signs that the vaccine induced an immune response.   "
100525|NCT01970345|"     The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of     autism. We will use a double-blind, placebo-controlled crossover trial design in five     children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments     in socialization, language, and repetitive behaviors. We expect to provide evidence for the     safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic     Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on     secondary outcomes of social impairment, language delay, and repetitive behavior, as well as     on functional outcomes of global severity.   "
100526|NCT01970332|"     Intermittent claudication afflicts 5% of the US population older than 55 years of age and     develops along with hardening of the arteries of the legs. Claudicating patients limp and can     only walk very short distances because their legs hurt. This protocol evaluates the     mechanisms that may produce the leg dysfunction of claudication and its successful completion     can ultimately produce significant new diagnostic and treatment strategies for the care of     claudicating patients.   "
100696|NCT01968109|"     To assess the safety and tolerability, characterize the dose-limiting toxicities, and     identify the maximum tolerated dose of BMS-986016 alone and in combination with Nivolumab in     subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide     preliminary information on the clinical benefits of the combination.   "
101911|NCT01952184|"     The survival rate (and embryo quality) of donor oocytes with two commercially available     devices.   "
100527|NCT01970319|"     Patients with diabetes have a higher incidence of heart failure and worse outcomes than     normoglycaemic subjects. Basic science research has suggested many mechanisms for this     observation including endothelial dysfunction, abnormal calcium handling, fibrosis and     activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are lacking.     In this study the investigators will investigate the relationship between diabetes and heart     failure by exploring the correlation between microvascular dysfunction and cardiac magnetic     resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction and     fibrosis. The investigators also propose to see if this relationship is independent of blood     pressure and markers of RAAS activity. This could have important clinical ramifications in     type 2 diabetes by increasing the indications for treatment with RAAS inhibition or making a     case for lower blood pressure targets.   "
100528|NCT01970306|"     The purpose of this study is to see if implanting MatriStem will lower the risk of one of the     more common complications after stomach or esophagus surgery.   "
100529|NCT01970293|"     The primary aims of this study are to test the hypotheses that among alcohol abusing and     dependent jailed women returning to the community, adding an Alcoholic Anonymous (AA) linkage     intervention will result in less alcohol use at follow-up, increased AA attendance once     released, and decreased HIV/STI sexual risk behavior. Additionally, this study seeks to test     the hypotheses that increased AA attendance will mediate the effect of the AA linkage     intervention on alcohol use and that percent days abstinent will mediate the effect of the     intervention on HIV/STI sexual risk-taking outcomes.   "
100530|NCT01970280|"     The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV     graft thromboses in patients on chronic hemodialysis.      Primary efficacy end point of the study: to compare the time of onset of a new thrombotic     event after successful angiography of the AV graft.      Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following     a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on chronic     hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body weight per day     or control group (not on Clexane). Patients will be followed for a year or till next AV graft     thrombotic occlusion, if it occurs before. In both groups we will compare time periods in     months between first and recurrent thrombotic events of AVG by evaluation the difference     between two sample means. Also interim analysis of AV grafts patency between the two groups     will be evaluated at different time points: three, six and twelve months after randomization.     Patients in both groups will receive unfractionated heparin during dialysis session to     prevent thrombosis of extracorporeal circulation. Patients from Enoxaparin group will receive     a half dose (500 units/hour) to prevent possible risk of bleeding during the session. Before     randomization all patients will be evaluated for hypercoagulability state which will include:     Factor V Laden deficiency, Anti phospholipid antibodies (APLA), Antithrombin III deficiency     and Protein C/S deficiency.   "
100531|NCT01970267|"     Vitreous floaters are tiny, cloudy, clumps of cells that appear in the otherwise clear fluid     (vitreous) that fills the back 3/4 of the eye. Floaters are commonly caused by eye conditions     such as posterior vitreous detachment (PVD), vitreous syneresis and asteroid hyalosis. While     these symptoms are considered physiological in nature, they can be of considerable     inconvenience to many patients which affect essential activities. The investigators wish to     assess the safety and efficacy of floater treatment in patients with highly symptomatic     floaters using an FDA approved nanosecond infrared yttrium aluminum garnet (YAG) lasers.   "
100532|NCT01970254|"     The goal of this clinical research study is to learn about testing patients for viral     infections before chemotherapy. Researchers want to learn which patients are at higher risk     for these infections so that, in the future, patients might be able to be tested more     effectively.   "
100533|NCT01970241|"     Despite a significant problem with out-of-control glucose levels in patients with diabetes     receiving corticosteroids for a variety of illnesses, there are no published protocols     addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators     propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin     for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed     to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's     usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.     Investigators will prospectively enroll eligible consented patients with diabetes who are     receiving corticosteroids as part of their treatment in a large county hospital, will     randomize them to intervention or control groups, and will monitor their glucose levels     during their inpatient stay. The protocol will demonstrate improved control of glucose levels     with minimal risk of hypoglycemia, and will provide a practical and readily implementable     protocol using NPH insulin as therapy for corticosteroid-induced diabetes.   "
100534|NCT01970228|"     Total hip replacement is the well-established surgical method for treatment of hip     osteoarthritis and related diseases. The outcome of the procedure is commonly satisfactory     and most patients will not need any revision surgery. However, the procedure has its     complications, including (1) periprosthetic infection, (2) mechanical loosening caused by     wear particles and (3) adverse reaction caused by metal ions released from metal-on-metal     bearing surfaces. The unsolved clinical problem is related to the differential diagnosis of     these conditions. The purpose of this prospective clinical study is to compare the efficacy     of two techniques of PET/CT imaging in the differential diagnosis of these complications.     Positron Emission Tomography (PET)/Computed Tomography (CT) imaging, performed during a     single day, will include the head-to-head comparison of 18F-Fluoro-D-Glucose (18F-FDG) PET/CT     and 68Gallium-citrate (68Ga-citrate) PET/CT imaging.   "
100535|NCT01970215|"     The primary objective of this study is to evaluate the efficacy of different doses of     TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of     high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein     cholesterol (LDL-C), alone and in combination with statin therapy.      The secondary objectives of this study are to determine the safety and tolerability of     TA-8995 in patients with mild dyslipidaemia.   "
100739|NCT01967550|"     This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient     suffering from knee osteoarthritis (OA).   "
102779|NCT01940861|"     Vasopressor for current treatment protocols for acute traumatic brain injury can lead to     vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry     as a drop in SCO2.   "
100536|NCT01970202|"     Approximately two thirds of the adult population in developed countries is categorized as     over-weight or obese (BMI>30). In spite of worldwide increasing awareness, obesity is a major     health concern. In the presence of numerous diets, medical therapies, and robust research,     bariatric surgery remains the most effective means of weight reduction in morbidly obese     patients (BMI>40, or BMI>35 with co-morbidities). However, bariatric surgery harbors a     relatively high risk for postoperative complications; of them, venous thromboembolic events     (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly     obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.      To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in     the aforementioned population. Due to the pharmacologic properties of LMWH and the     characteristics of surgically treated obese patients, the optimal dose that is to be utilized     for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the     patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have     been proposed by some authors for VTE prophylaxis.      Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h)     for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were     small non- randomized trials, containing numerous methodological weaknesses. Hence, the     optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed     population remains unclear.      The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two     most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and     homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric     surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients     undergoing bariatric surgery.   "
100537|NCT01970189|"     Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet     count, which may cause the patient to have a higher risk or increased duration of bleeding.     Individual hospitals only encounter a small number of ITP patients each year which makes it     difficult to study this disease. By creating this disease registry, we will be able to build     a more complete picture of ITP, including treatment practices, through collecting information     about the condition from patients across several hospitals in several countries. Research of     this kind will help future patients by providing doctors with information about ITP, and     about how patients have been treated.   "
100538|NCT01970176|"     To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo     on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral     response to acute sodium loading in subjects with preclinical systolic dysfunction (PSD) and     renal (kidney) dysfunction.   "
100539|NCT01970163|"     The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers     (DFU) and venous stasis ulcers (VSU).   "
100540|NCT01970150|"     The purpose of this study is to examine whether the rTMS (repetitive Transcranial Magnetic     Stimulation) could change cortical excitability measured by off-line EEG in Alzheimer's     Disease (AD) patients.   "
100541|NCT01970137|"     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of     KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)   "
100542|NCT01970124|"     The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics     of KPS-0373 in SCD patients   "
100543|NCT01970111|"     The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics     of KPS-0373 in SCD patients.   "
100544|NCT01970098|"     The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and     evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.   "
100545|NCT01970072|"     The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics     and safety of Remimazolam Tosylate with midazolam in healthy volunteers   "
100546|NCT01970059|"     The aim of present study is to evaluate the efficacy and safety of Extended-Release     Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension   "
100547|NCT01970046|"     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the     efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2     Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control   "
100548|NCT01970033|"     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the     efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in     Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for     3 months   "
100549|NCT01970020|"     The purpose of the study is to investigate the absorption, metabolism, and excretion of 14C     JNJ-38518168 in healthy adult male participants after a single oral dose of 30 mg 14C     JNJ-38518168.   "
100550|NCT01970007|"     The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the     Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow     obstruction.   "
100551|NCT01969994|"     The purpose of this study is to determine the absorption, metabolism and excretion of     (-)-epicatechin using the radiolabeled tracer (-)-[2-14C]epicatechin in healthy male     volunteers observing a flavanol-/procyanidin-controlled background diet.   "
100552|NCT01969981|"     This is a prospective, single center, observational study. Patients who require a Peripheral     Inserted Central Catheters (PICC) will constitute the study population.      The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the     total placement of PICC and confirmation of tip of PICC placement and if this method can be     conducted safely and efficiently.      Patients will be included during a 6-month period as well as they are ambulatory or     hospitalized. The patient's routine care will not be modified and only PICC will be assessed     in the present study.      PICC placement will be performed using the Site Rite guidance and tip position will be     confirmed using the Sherlock 3CG.      The procedure is the same as the routine habits of the operator (nurse or anesthesiologist);     the vascular access team already uses the previous device for CVC placement.      Patients won't be followed up in the study.   "
100553|NCT01969968|"     1. To study the kinetics of release after bariatric surgery of selected polluants stored in          adipose tissue, looking for clinical and/or predictive factors        2. To test the hypothesis of a deleterious effect of this release on the expected          improvement of insulin-resistance and on the liver inflammation.        3. To determine the level of contamination of morbidly obese patients, with or without          metabolic syndrome, compared to a control, non obese population, with special attention          to clinical (age, gender, reproductive history, pregnancy, nursing) and biological          parameters (insulin-resistance, inflammation).   "
100554|NCT01969955|"     The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in     previously treated advanced or metastatic squamous lung cancer.   "
100760|NCT01967264|"     The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg     compared to placebo.   "
100555|NCT01969942|"     The purpose of this study is to examine the toxicity of using allogeneic stem cell     transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES).     Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ     [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for     Transplant for Donors to match with recipient]) matched related or unrelated donors.     Specifically, we will examine:        -  The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as          related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).        -  The incidence of transplant related mortality at 100 days.   "
100556|NCT01969929|"     To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a     laser flare-cell meter in 20G versus 23G vitrectomy.   "
100557|NCT01969916|"     Our hypothesis is that quantitative 3D analysis of cardiac CT images obtained during     vasodilator stress can accurately identify patients presenting at the emergency department     with acute chest pain due to underlying hemodynamically significant coronary stenosis, aid in     the identification of individuals most likely to benefit from revascularization, and thus     improve the ability to predict patient outcomes.      Our goals are:        1. to test the above hypothesis by comparing stress MDCT perfusion data with invasive          fractional flow reserve (FFR) data in patients with significant stenosis who undergo          ICA;        2. to determine the added value of MDCT perfusion as an adjunct to CTCA for predicting          patient outcomes.   "
100558|NCT01969903|"     The purpose of this study is to find out the proper amount of a drug called dexmedetomidine     added to the local anesthetic drug called lidocaine to prolong the time and effect of pain     relief provided for surgery.      Dexmedetomidine (trade name Precedex) is approved by U.S. Food and Drug Administration (FDA)     and indicated for sedation (calming effect). It has both pain relieving and calming effects     when added to lidocaine. In the past, addition of higher amounts of dexmedetomidine to     lidocaine decreased blood pressure and heart rate. The investigators plan to study the effect     of lower amounts of dexmedetomidine to achieve the same level and duration of pain relief     without reduction of blood pressure and heart rate.   "
100559|NCT01969890|"     The purpose of this study is to demonstrate that granulocyte colony-stimulating factor     (G-CSF) therapy in addition to state-of-the-art treatment (pharmacological and non     pharmacological) is safe and significantly improves clinical outcome in patients with reduced     left ventricular ejection fraction (LVEF) (≤45%) after successful reperfusion for large     anterior acute myocardial infarction.   "
100560|NCT01969877|"     The primary endpoint in this study is to investigate if there is a difference in overall     survival in patients with locally advanced head and neck cancer, randomized to either     radiotherapy and cetuximab or radiotherapy and cisplatin. A second randomization is performed     in patients with T3-T4 tumors; allocated radiotherapy either 68.0 Gy or 73.1 Gy.   "
100561|NCT01969864|"     The purpose of this study is to determine the effect of brief organ donation video     interventions on consent for organ donation among college and university students. Our     hypothesis is that the organ donation video interventions will be superior to lay health     websites for increasing organ donation consent.   "
100562|NCT01969851|"     SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in     children with epilepsy syndromes associated with generalized seizures. LCM will be added to     current antiepileptic treatment.   "
100563|NCT01969838|"     This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib in     participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential     thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a     Janus kinase inhibitor (JAK inhibitor).      Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a     double-blind treatment phase, after which they will be eligible to receive open-label MMB for     up to an additional 216 weeks. After discontinuation of study medication, assessments will     continue for 12 additional weeks, after which participants will be contacted for survival     follow-up approximately every 6 months for up to 5 years from the date of enrollment or until     study termination. For those participants planning to continue treatment with MMB following     the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and     survival follow-up visits are not required.   "
100564|NCT01969825|"     The purpose of this prospective, randomized study, was to determine if neck and shoulder     massage performed within 15 minutes of semen sample collection will increase the semen     volume, and therefore increase the total motile sperm available for insemination as a result     of decreased stress.   "
100565|NCT01969812|"     The purpose of this study is to determine patient satisfaction and tolerability of the Evie®     slow-release insemination device for US population. Additionally, to assess cramping with the     device and to determine pregnancy rates using the slow insemination device compared to     standard IUI.   "
100566|NCT01969799|"     To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin     inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in     mechanically ventilated patients receiving IV antibiotics.   "
100567|NCT01969786|"     VIEW is a community-randomized trial designed to determine whether it is possible to prevent     corneal ulcers on a large scale. The study compares the incidence of corneal ulceration     between villages in which volunteers are trained to diagnose and treat corneal abrasions and     villages which receive no intervention.   "
100568|NCT01969773|"     This study was designed in a multicenter, randomized, double-blind, placebo controlled trial     to test the actual therapeutic effects of intravesical BoNTA injection. The results of this     study might provide clinical evidence for a better therapeutic regimen in the treatment of     IC/PBS.   "
100569|NCT01969760|"     The purpose of this study is to examine the feasibility and acceptability of a family-based     program to improve physical activity and tobacco outcomes in a small pilot of middle school     students and their families.   "
100570|NCT01969747|"     Placebo-controlled, double blind (triple-dummy technique), randomised parallel design     comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with     T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label     placebo run-in period before randomisation. Background insulin therapy will be kept stable     during the first 7 days of the treatment period and will be freely adjusted thereafter.   "
100571|NCT01969734|"     Despite the best medical therapy many people with emphysema remain breathless and limited in     their daily activities. In emphysema the lungs do not empty properly when the person breathes     out. This gas trapping makes it harder to breathe. Endobronchial valve placement, a     treatment that stops air getting into the worst affected parts of the lung and so stops them     from trapping gas, improves lung function, breathlessness and exercise capacity in selected     patients with severe COPD (chronic obstructive airways disease, sometimes referred to as     emphysema). We want to see if people with less severe COPD who are very breathless can     benefit from the same treatment. The treatment involves placing small valves into the airways     using a fibre optic camera (a bronchoscopy). Bronchoscopy is a standard clinical procedure     carried out in our department.   "
100572|NCT01969721|"     The objective of the trial is to compare the lung function profile of once daily treatment     with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung     function profile of twice daily treatment with fluticasone propionate+salmeterol FDC     [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.   "
100573|NCT01969708|"     SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which all     participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as a     non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg) every     4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine if     bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with     central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at     Month 6.   "
100574|NCT01969695|"     This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's     lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma     [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active     and assigned to ABT-199 when the study was completed, may roll over into this extension     study. Subjects will receive ABT-199 during this study.   "
100575|NCT01969682|"     This is an open-label multicenter, study to assess the pharmacokinetic interaction of     rifampin with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's     lymphoma.   "
100576|NCT01969669|"     This is an open-label multicenter, study to assess the pharmacokinetic interaction of     ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's     lymphoma.   "
100577|NCT01969656|"     Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28     days in healthy normal postmenopausal women.   "
100578|NCT01969643|"     This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic     breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with     trastuzumab.   "
100579|NCT01969630|"     To determine in patients with symptomatic femoropopliteal lesions whether percutaneous     revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol     stent is superior with respect to the 12-month incidence of restenosis compared to treatment     with systematic paclitaxel-eluting stent (PES) angioplasty   "
100580|NCT01969617|"     To contribute to the understanding of the underlying neurobiological mechanism behind the     interaction of alcohol and nalmefene   "
100581|NCT01969604|"     Background:      In recent years there has been a growing interest in sedentary behaviour defined as     activities performed in sitting or lying position during waking hours. Sedentary behaviour     has been recognised as an independent risk factor for cardiovascular diseases and mortality.     A few intervention studies in older sedentary people and in overweight or obese adults have     demonstrated, that daily sitting time can be reduced through behavioural intervention.      Patients with rheumatoid arthritis (RA) have an increased risk for cardiovascular diseases,     partly caused by the rheumatic disease itself but also because of physical inactivity.     Studies have documented a positive effect of increasing physical activity on pain and     physical functioning in patients with RA. However, the studies also show, that the patients     find it difficult to maintain the increased physical activity levels over time. Previous     studies suggest that in promoting health among patients with mobility disability should not     solely focus on increasing moderate to vigorous physical activity but also target reduction     of sedentary behaviour and increase of light physical activity. In the present study we will     focus on reduction of daily sitting time and increase of light physical activity as this     approach may prove more feasible for patients with RA.      Objectives and hypothesises:      We hypothesise, that sedentary behaviour can be reduced in patients with RA through a     behavioural lifestyle change. In addition, we hypothesize, that reduction of daily sitting     time can have a positive effect on symptoms and general health in patients with RA.      The primary objective of the present intervention study is to investigate the effect of a     motivational counselling intervention on daily sitting time in adult men and women with RA.     Furthermore we want to investigate whether a reduction in daily sitting time is related to     reduction in pain and fatigue, reduced weight and waist circumference and improved quality of     life, physical function and improved cardiovascular biomarker levels (cholesterol and blood     pressure).      Study setting and allocation:      In total, 150 participants will be recruited from the rheumatology outpatient clinic at     Glostrup University Hospital, Denmark. The participants will be allocated to either an     intervention group (75) or a control group (75).      Intervention:      The intervention aims to support and strengthen the participants' belief in their own ability     to reduce their daily sitting time. The intervention will include 1) three individual     motivational counselling sessions (60-90 minutes), conducted by one of four project nurses in     combination with 2)Individual Short Text Messages (SMS). The counselling sessions will focus     on information about the positive health effects of reducing daily sitting time and the     participants' own goals of reducing their sitting time. Based on the goals the participants     will receive weekly SMS reminders.      Data collection:      Measurements on all participants will be done four times during 22 months; 1) at baseline, 2)     16 weeks after start (by the end of the intervention), 3) six months after end of     intervention and 4) 18 months after end of intervention. At each of the four visits the     participants fill in questionnaires regarding demographics, lifestyle, daily sitting time,     physical activity, physical function, pain , fatigue and quality of life. Furthermore, two     occupational therapists will measure the participants' blood pressure, height, weight and     waist circumference. At the same time a little monitor will be placed on the participants'     thigh, which they will carry for seven days. The monitor measures the participants' physical     activity level. The four measurements also include a blood sample from the participants in     order to measure cholesterol levels.   "
100582|NCT01969591|"     To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic     surgery.   "
100583|NCT01969578|"     Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached     by multidisciplinary teams in high specialized centers. Until today no standard of care     exists to treat these cancers. The identification of a target, the androgen receptor, in SG     tumors has allowed for new treatment strategies options for this rare group of diseases. As a     matter of fact, strong positivity for androgen expression has been found in salivary duct     carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the     efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients     with recurrent and/or metastatic AR expressing SGCs.      The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve     patients, and Cohort B, which comprises pretreated patients.   "
100584|NCT01969565|"     The purpose of this study is to evaluate the safety and tolerability of increasing doses of     carfilzomib in combination with dexamethasone   "
100585|NCT01969552|"     TSH plays a central role in current thyroid function testing both as a diagnostic tool and     therapeutic target. Recent studies have suggested a more complex and hierarchical     relationship between logTSH and FT4 over the entire functional spectrum than the widely     assumed single log linear gradient (1-4). Our group has also shown a disjoint between     pituitary TSH and FT3 serum levels being operative under conditions of levothyroxine     monotherapy (5).      The present prospective observational study aims at confirming some of these findings and     exploring additional factors other than TSH that may be important in shaping the     interrelation of thyroid parameters and modulating thyroidal activity in health and disease.      To this purpose, unselected patients presenting for thyroid testing or treatment to a     specialised unit at a teaching hospital will be prospectively studied to assess the interplay     of FT3, FT4 and TSH under various conditions, and to evaluate various thyroidal and     non-thyroidal influences, such as disease entity, thyroid volume, deiodinase activity,     thyroid medication, surgery, radioiodine treatment, age, BMI, smoking on pituitary set-point     and homeostatic equilibria.   "
100586|NCT01969539|"     The general aim of this 1-day, open label, non-randomised, trial is to characterize the     performance of two adapter devices designed to permit use of the Respimat® inhaler with     patients requiring mechanical ventilation.   "
100605|NCT01969292|"     Our team has created an automated, real-time software based image analysis tool called     Colometer to improve screening colonoscopy providing real time visual feedback on image     quality. There are three components to this study. The first is to validate the bowel     assessment preparation using the recorded colonoscopy videos from 50 consented normal risk     patients. In the second phase, technological and machine user interface refinements will be     identified and completed. Finally, the third phase will be a sham controlled prospective     study of Colometer versus standard care in 100 consented average risk patients undergoing     screening colonoscopy as performed by 10 consented endoscopists.   "
102780|NCT01940848|"     The study shall prove whether treatment of irritable bowel syndrome with Iberogast is     superior to placebo.   "
100587|NCT01969526|"     Objective: To evaluate the effectiveness of a multifactorial intervention program based on     physical activity and diet, memory workshops and review of medication, to modify frailty     parameters, muscle strength and physical and cognitive performance in people 65 years or     older with a positive screening for frailty. Secondly, to assess changes in falls,     hospitalizations, nutritional risk, disability and institutionalization or home-care.      Methods: randomized clinical trial with a control group, of one year and a half of follow-up,     conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years     or older with positive frailty screening, timed get-up-and-go less than or equal to 20     seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected     in each group (difference to be detected on physical performance (Short physical performance     battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).      Intervention: consists in three different actions on frailty dimensions, applied to each     subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus     intake of hyperproteic shakes, memory workshop and review of the medication.      Evaluations will be blinded and conducted at 0, 3, 12 and 18 months. Analysis of variance for     repeated measures to adjust for differences attributable to intervention effect and for     potential confounders such as comorbidity, sensory limitations, social risk, other medical or     social interventions, among others.   "
100588|NCT01969513|"     Vertigo is a common medical issue with a broad expectrum of diagnoses that requires a global     approach to patients through structured clinical interview and physical examination. The main     cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV) that is     confirmed by a positive Dix-Hallpike positional test and treated with repositioning     manoeuvres. Objective: To evaluate the effectiveness of Epley's manoeuvre performed by     general practitioners (GPs) in the treatment of BPPV. Design: randomized clinical trial     conducted in primary care. Scope: Two urban centres serving about 50,000 patients. Patients:     All patients with newly diagnosed BPPV will be offered to participate in the study and will     be randomly assigned to the treatment group (Epley manoeuvre) or control group (sham     manoeuvre) and both groups will receive betahistine. Outcome variables will be: response to     the Dix Hallpike test, patients will inform if vertigo was present during the last week     (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert scale in the past     week, score of Vertigo Handicap Inventory and quantity of betahistine taken. Statistical     analysis: Descriptive statistics of all variables collected. Groups will be compared using     the intent-to-treat approach and either parametric or nonparametric tests depending on the     nature and distribution of the variables. Chi-square test or exact Fisher test will be used     to compare qualitative measures and Student's t test o Mann Whitney U test will be used for     between-group comparison of variables.      Positive results from our study will highlight that treatment of BPPV can be performed by     trained GPs and its widespread practice can greatly improve the quality of life of these     patients.   "
100589|NCT01969500|"     The goal of the proposed project is to develop and pilot a mobile Self-Management of     Schizophrenia (SOS) system that will administer interventions targeting persistent symptoms     of psychosis, social dysfunction, and poor medication adherence, with the long-term goal of     creating a widely-available system that can be deployed by users as needed, in their own     environments. The hypothesis is that this intervention group will show stronger improvement     in the areas of psychiatric systems, social function, and medication adherence compared to     treatment as usual.   "
100590|NCT01969487|"     Surgical residents and fellows acquire operative knowledge and skills by assisting attending     surgeons in the operating room. Previous research has shown that practising technical skills     prior to operating on patients can improve how skillfully laparoscopic surgery can be     performed. Although an increasingly large number of patients are undergoing robotic     hysterectomy and other robotic surgical procedures, little is known on how to ensure patient     safety and treatment effectiveness when trainee surgeons participate in the operating room.     Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery     simulator by gynecologic surgical trainees on their intraoperative performance and on patient     outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major     academic medical center to either warm-up immediately before surgery on a robotic surgery     simulator or to not warm-up. The attending surgeon supervising the trainee in the operating     room is unaware of whether the trainee was assigned to warm-up or no warm-up. The     investigators will compare standard robotic surgical skills assessments of the trainees by     the supervising attending surgeons and patient outcomes in the two groups.   "
100591|NCT01969474|"     The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as     experienced by the patients.   "
100592|NCT01969461|"     Alcohol use among persons with HIV exacerbates health problems and accelerates HIV disease     progression. Antiretroviral therapy (ART) is the single most important treatment for people     living with HIV. However, ART adherence is suboptimal among adolescents and young adults     living with HIV, the age group with the fastest growing rates of HIV infection, and great     risk of engaging in risky behaviors such as alcohol use. The proposed study will compare the     effectiveness of home-based versus clinic-based Healthy Choices, a brief, 4- session     intervention using Motivational Enhancement Therapy (MET) to address alcohol use, medication     adherence, and health outcomes in youth living with HIV (YLH) using a repeated measures     design. Unlike previous trials, Healthy Choices will be tested in a real world clinical     setting and be delivered by community health workers (CHW: already members of the HIV care     team). The study population will consist of YLH, ages 16-24, who are current patients at 5     ATN sites. Site staff will recruit potential participants. Youth will be randomized to     receive Healthy Choices, either clinic-based or home-based delivered by the same CHW in both     conditions. Outcomes are measured at baseline, 4-, 7-, and 13-months. Data collection for     biological measures will be through medical record extraction, and self-reported measures     will occur using a brief Web-based CASI (computer-administered self-interviewing) survey on     an iPad. All intervention sessions will be audio-recorded for MITI fidelity coding, and     investigators will support local supervisors during the active intervention phase. We will     conduct qualitative interviews with CHWs, supervisors and organization leaders at the end of     the trial to obtain information about barriers and facilitators of implementation. Thus, the     proposed trial will allow us to use a Type 1 Effectiveness-implementation hybrid design to     pilot a sustainable model of MI implementation in real-world youth care settings towards the     goals of 1) examining the effectiveness, cost-effectiveness, and scalability of an     efficacious behavioral intervention when delivered by CHWs in real-world adolescent HIV care     settings; 2) gathering information about who responds under what contexts; and 3) increasing     our understanding of the barriers and facilitators for future implementation. The primary     hypothesis is that YLH receiving home-based MET will have greater improvements in alcohol use     and viral load than YLH receiving clinic-based MET.   "
100761|NCT01967251|"     The purpose of this study is to evaluate the efficacy, dose-response and safety of udenafil     25 mg, 50 mg and 75 mg every day (q.d.) for 12 weeks in the treatment of lower urinary tract     symptoms (LUTS) associated with benign prostatic hyperplasia (BPH and for the treatment of     erectile dysfunction (ED).   "
100593|NCT01969448|"     The primary hypothesis of this study is to determine which of two incision sites     (inframammary fold incision or the lateral radial incision) provides a more robust blood     supply to the skin envelope during nipple-sparing mastectomy with immediate reconstruction.      Following education about the trial and informed consent, patients will be randomized to one     of the two incisions. If their surgeon recommends a particular incision, there is also a     non-randomized cohort. Patients will complete the Breast Q, a questionnaire prior to surgery     and three months after surgery to capture quality of life data. During the surgery,     laser-assisted fluorescent angiography will be performed three times to look at blood     perfusion with the Spy Elite imaging device.      Patients will be required to return for postoperative follow up visits. All patients will be     seen approximately one week, three weeks, and six weeks after surgery. Patients with a direct     implant will finish the study at their three month post-operative visit. Patients with an     expander will finish the study three months after their final implant is placed.   "
100594|NCT01969435|"     Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan     HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative     conditioning in lymphoma patients undergoing ASCT   "
100595|NCT01969422|"     Comparison of online question-answering system and conventional consultation for     dermatological questions:        -  same diagnosis?        -  same information, which had been collected?        -  same recommendations about treatment?        -  what were the relevant differences of the two?   "
100596|NCT01969409|"     Recent research studies have suggested that proteins called antibodies that are produced by     the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis     (IPF). Antibodies produced by the immune system normal help to fight infections by attacking     bacteria and viruses without harming our own tissues. In patients with IPF, there is evidence     that certain antibodies (called autoantibodies) attack the lung and contributes to the injury     and scarring that occurs in IPF. Our recent studies have found that many IPF patients appear     to have excessive autoantibody levels in blood and lungs that might make their disease worse.      Rituximab is a medication approved by the Food and Drug Administration (FDA) for the     treatment of autoantibody diseases such as rheumatoid arthritis. Rituximab works by     destroying B cells, a type of white blood cell, called a B-lymphocyte, which produce     autoantibodies. In this research study, rituximab will be given into a vein to reduce the     autoantibody levels that we believe might be contributing to the lung damage in IPF.      This study is being conducted to determine if rituximab provides beneficial effects for IPF     patients by decreasing further lung injury.   "
100597|NCT01969396|"     To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.   "
100598|NCT01969383|"     Muscle activity in the aquatic environment was investigated while performing different     exercises by electromyography analysis, due to conflicting results in the literature in     relation to the floor. This study evaluated and compared the electrical activity of the     rectus femoris and biceps femoris, in aquatic method and on the floor, during flexion and     knee extension exercises with and without load.   "
100599|NCT01969370|"     This study is part of a larger consortium project investigating the validity and best use of     next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care.     This sub-project is investigating benefits and harms of providing WES diagnostic and     different types of incidental findings to adult patients and parents of pediatric patients     who undergo WES because they have symptoms suggesting genetic disease.   "
100600|NCT01969357|"     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the     effective dose range of SP2086 in Patients with type 2 diabetes.   "
100601|NCT01969344|"     The purpose of SPIROMICS is to learn about chronic obstructive pulmonary disease (COPD),     which is sometimes called emphysema or chronic bronchitis. Millions of Americans have COPD,     and it is the fourth leading cause of death in the country. The most common cause of COPD is     cigarette smoking, although not all smokers get COPD. The discovery of new treatments for     COPD has been slowed by a poor understanding of different types of COPD and a lack of ways to     measure whether or not COPD is getting worse.      The study has two main goals. The first is to find groups of patients with COPD who share     certain characteristics. Certain groups may respond differently to certain treatments. The     second is to find new ways of measuring whether or not COPD is getting worse. This would     provide new ways of testing whether a new treatment is working.      SPIROMICS has three substudies and two ancillary studies.      Substudies:        1. Repeatability Substudy: The entire baseline clinic visit will be repeated on 100          volunteers. The goal of this substudy is to determine reliability of measurement          procedures.        2. Bronchoscopy Substudy: 300 participants will be enrolled for two additional study          visits, including a bronchoscopy. The goal of this substudy is to collect and assess          biological specimens and relate those results to clinical measurements.        3. Exacerbation Substudy: Up to 400 participants will be enrolled in this substudy. A daily          symptom diary will be collected on all participants. Participants will also be seen in          the clinic during a pulmonary exacerbation. The goals of this substudy are to 1) better          understand the relationship between symptoms and exacerbations and 2) obtain clinical          data and specimens during a pulmonary exacerbation.      Ancillary Studies:        1. Air Pollution Ancillary Study: The SPIROMICS Air Pollution ancillary study uses          state-of-the art air pollution exposure assessments to determine individual-level          outdoor and indoor air pollution exposure. The goals of this substudy are to determine          the effect of long-term air pollution exposure on COPD morbidity and to determine          whether short-term changes in outdoor air pollution are associated with changes in COPD          morbidity.        2. Parametric Response Mapping in COPD: The Parametric Response Mapping (PRM) in COPD          ancillary study collects an additional CT scan during the final study visit and uses a          new analysis technique (PRM) to assess the functional small airways of the lung and          emphysema.   "
100602|NCT01969331|"     The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an     add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach.      The primary objective in the study is determination of efficacy of Normia® probiotic as a     supportive therapy in achieving a higher percentage of eradication of H. Pylori.      The secondary objectives are to assess:        -  Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of          side-effects and better compliance to the eradication therapy        -  Safety and efficacy of Normia® probiotic in different demographic subgroups   "
100603|NCT01969318|"     SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the     efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2     Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control   "
100604|NCT01969305|"     This pilot study will adapt and test the feasibility and estimate the effect size parameters     of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to     reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females     and males living in communities highly affected by heroin trade and use in Almaty,     Kazakhstan.   "
100775|NCT01967069|"     The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle     Spray for topical treatment of moderate plaque psoriasis   "
124160|NCT01660620|"     We hypothesize that topical betaxolol will reduce the development of severe retinopathy of     prematurity.   "
100608|NCT01969253|"     Over the past few years, several studies have been made on various outcomes about the     incidence of lymphedema. Because the outcomes can be came out differently each study by     measurement, criteria, treatment period, treatment method and morbid extremities of     lymphedema. Therefore it is required for understanding about the incidence, risk factor and     physical progress for to be treated and prevented of lymphedema. Also it is necessary that to     understand characteristics of lymphedema measurements and to establish diagnostic criteria of     lymphedema through comparative study.      The aim of this study was to analyze the incidence and risk factor of lymphedema through     prospectively observation, and to determine effects on the quality of life of lymphedema     after breast cancer surgery with ALND.   "
100609|NCT01969240|"     Our long-term goal is to promote evidence-based patient-centered evaluation in the acute     setting to more closely tailor testing to disease risk. To compare the use of risk     stratification tools with usual clinical approaches to treatment selection or administration,     we propose the following:        1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in          a pragmatic parallel patient randomized trial.           Hypothesis: The intervention will significantly increase patient knowledge, engagement,          and satisfaction with no increase in adverse events.        2. Test if the decision aid has an effect on healthcare utilization within 30 days after          enrollment.      Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate     of cardiac testing, and total healthcare utilization.   "
100610|NCT01969227|"     Maintaining the patency of upper airway in sedated and anesthetized patients is challenging     especially when patients are ready to be weaned from mechanical ventilation. Impairment of     airway patency is a common cause of extubation failure and opioids and hypnotics can     adversely affect airway patency.      Ketamine, a noncompetitive antagonist of N-methyl-D- aspartate (NMDA), unlike other     anesthetics activates respiratory effort and promotes bronchodilation. At subanesthetic     plasma concentration, ketamine reduces both opioid and propofol requirements. Recent animal     data suggests that when added to propofol in a sedation regimen, ketamine decreased     hypoventilation when compared to propofol alone because ketamine can increase genioglossus     phasic activity while abolishing the coupling between loss of consciousness and upper airway     dilator muscle activity. However, this relationship has not been examined in human in     combination of other drugs.      The purpose of this pharmaco-physiological interaction trial is to evaluate the effects of     ketamine on breathing and electroencephalography in mechanical ventilated patients.     Spirometry will be utilized to evaluate upper airway patency. Polysomnography (PSG- Alice     PDx) will be used to evaluate the effects of ketamine on EEG during wakefulness and sleep. An     esophageal balloon will be inserted to measure esophageal pressure, which enables us to     measure the effects of ketamine on transpulmonary pressure. A volumetric capnography, NICO     noninvasive device from Respironics will be used to measure anatomical dead space, CO2     production, mean expiratory CO2 and slope of the alveolar plateau of the volumetric capnogram   "
100611|NCT01969214|"     Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several     studies demonstrating their efficacy, the investigators are conducting this study to look     into the efficacy and safety of IQP-MM-101 in diarrhoea control.   "
100612|NCT01969201|"     The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety     of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled     ovarian hyperstimulation in a GnRH-antagonist cycle.   "
100613|NCT01969188|"     Spondyloarthritis refers to a set of inflammatory disorders that mainly afflict the spine,     joints and ligaments. A subtype of spondyloarthritis is Ankylosing Spondylitis - now known as     axial spondyloarthropathy - which is characterized by inflammation of the joints in the     spinal column, and the part of the back where the spine meets the pelvis. Another subtype of     spondyloarthritis is Psoriatic Arthritis where patients often develop raised patches of     reddened skin. The disease can advance to one of more joints in the body resulting in pain,     swelling and stiffness. These forms of inflammatory arthritis can become chronic and over     time can lead to pain, disability and deformity.      There is now evidence that patients with inflammatory arthritis that are diagnosed and     treated earlier in the course of their symptoms may have better results. Yet although we know     that early treatment is important, the investigators still don't know if there are factors     that can predict how an individual patient's disease will progress over time in terms of     losing mobility. The investigators also do not know the relationship between loosing mobility     and the formation of bone around the spine and joints.      The investigators are doing this study because the investigators want to learn more about     patients with these forms of arthritis - Ankylosing Spondylitis and Psoriatic Arthritis. The     investigators want to learn more about the factors that can predict how their disease might     progress over time and what their response to treatment might be. The investigators would     also like to determine the proportion of patients with these types of symptoms and describe     the best treatment strategies for them.   "
100614|NCT01969175|"     The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet     on acne severity.      IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both     groups to explore the mTORC signaling pathway, which is thought to be related to clinical     improvement in previous studies.   "
100615|NCT01969162|"     This exploratory study will collect tear samples from adult volunteers for determining and     quantifying tear composition profiles. No investigational drug will be administered in this     study.   "
100632|NCT01968941|"     A multi-centre randomized controlled open-label trial in medically inoperable patients with     biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting     patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or     conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as     possible following randomization and subjects will be followed for 5 years post-randomization     for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The     trial will be conducted at 16-20 clinical centres throughout Canada.   "
100776|NCT01967056|"     Respiratory failure following extubation causes significant morbidity and increases mortality     in teh surgical intensive care unit (SICU). However the causes of respiratory failure     following extubation remain poorly understood. The investigators hypothesize that extubation     failure can be predicted based on preoperative risk factors as well as ICU acquired     morbidities including muscle weakness and renal failure.   "
100616|NCT01969149|"     Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non     diabetic patients.      It has been shown that perioperative hyperglycemia is an independent risk factor of     postoperative mortality and morbidity.      The Leuven et al.'s study suggested that strict glycemic perioperative control using an     intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's     patients. This study included a majority of cardiac surgery patients. Others studies have     suggested that the beneficial effect of insulin-based tight perioperative glycemic control     might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain     perioperative glycemic stability in most patients.      Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect     that depends on the blood glucose level.      We hypothesize that continuous intravenous infusion of exenatide could improve perioperative     glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared     to a conventional insulin therapy during the perioperative period of cardiac surgery.   "
100617|NCT01969136|"     The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124     compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease     currently receiving stable treatment or previously treated with an acetylcholinesterase     inhibitor.   "
100618|NCT01969123|"     The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124     compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease     currently receiving stable treatment or previously treated with an acetylcholinesterase     inhibitor.   "
100619|NCT01969110|"     The purpose of this study is to investigate whether perioperative immunonutrition has     additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.   "
100620|NCT01969097|"     The aim of the study is to investigate whether the combination of bihemispheric (dual)     transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days     facilitates motor recovery in chronic stroke. Results will be compared to a matched group of     patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional     and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3     month follow-up will help investigating neural correlates of expected changes in motor     function of the affected upper extremity.   "
100621|NCT01969084|"     Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug,     treatment on inflammation as well as vascular and mitochondrial function in diabetic     patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state,     improve endothelial function, increase the blood flow at the muscle microcirculation level     and improve mitochondrial function. In this study, investigators will perform tests that     evaluate the function of small and large blood vessels by employing ultrasound and laser     doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the     lower extremity muscles at rest and during exercise will also be employed. Forty subjects     with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly     assigned to receive linagliptin while the other half will receive placebo. All tests will be     performed at the beginning and the end of the study.   "
100622|NCT01969071|"     The effects of levosimendan on renal function in patients with low ejection fraction     undergoing mitral valve surgery will be investigated in a prospective, double-blinded,     randomized clinical trial using serum creatinine (sCr)milligram in deciliter (mg/dL) values,     calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates and perioperative     clinical follow-up parameters.   "
100623|NCT01969058|"     This phase II study is being done in HIV-infected subjects on antiretroviral therapy to     evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of     severe acne) on the immune system. Your immune system helps your body fight infections. When     your immune system is not working well, you may be at greater risk for diseases that are     common in aging, like heart disease, weaker bones, and kidney disease.   "
100624|NCT01969045|"     The aim of this prospective study is to examine the benefits und risks of administration of     local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)     during flexible bronchoscopy.   "
100625|NCT01969032|"     The purpose of this study is to increase survival of patients with locally advanced     triple-negative breast cancer using two consequent induction preoperative chemotherapy     regimens.   "
100626|NCT01969019|"     This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12     weeks and 4 weeks.   "
100627|NCT01969006|"     This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ %     Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after     laparoscopic inguinal hernia repair.      Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.      Pain will be estimated using the VAS score in:      1. the wound 2 the abdomen 3 the shoulder      Scoring will be performed:        1. pre-operatively        2. 1 hour postoperatively        3. at discharge from the hospital d day 1,2 and 3 post OP      e. 1 year post OP   "
100628|NCT01968993|"     nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare     fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone     and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the     treated level(s). It is hypothesized that the use of nanOss Bioactive will result in fusion     at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational     motion, and less than 5 degrees of angular motion.   "
100629|NCT01968980|"     This is a multicenter, randomized study in subjects with heterozygous familial     hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and     tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.   "
100630|NCT01968967|"     This study is a multicenter, randomized study in subjects with high cholesterol receiving     highly effective statins to assess the efficacy, safety and tolerability of Bococizumab     (PF-04950615;RN316) to lower LDL-C.   "
100631|NCT01968954|"     This study is a multicenter, randomized study in subjects with high cholesterol receiving     highly effective statins to assess the efficacy, safety and tolerability of Bococizumab     (PF-04950615;RN316) to lower LDL-C.   "
102781|NCT01940835|"     This purpose of this study is to determine if activation of a person's immune system in the     small intestine could be a contributing cause of Type 1 Diabetes.   "
100633|NCT01968928|"     Bladder urothelial carcinoma (UC) is a common malignancy and the incidence is increasing by     years in Taiwan. Chemoresistance was inevitable in treatment of metastatic disease and lead     to the ominous outcomes. To develop novel therapeutic strategies to overcome chemoresistance     is imperative. Cancer cells uptake glucose at higher rates than normal tissue but use most of     glucose for glycolysis even under normoxia condition, which is known as the Warburg effect.     Pyruvate kinase (PK) catalyzes the last step in the process of glycolysis, and one of it     isoform--PKM2 has been reported to be associated with tumor progression and some specific     tissues and promotes the Warburg effect in cancer cells.   "
100634|NCT01968915|"     This study will evaluate safety and tolerability to estimate the maximum tolerated dose     and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.   "
100635|NCT01968902|"     The purpose of this study is to determine if Xeomin® will prove effective for significantly     improving lower extremity spasticity and will be well tolerated by the majority of MS     patients.   "
100636|NCT01968889|"     Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep     weakness involving the respiratory muscle work which result in a delayed weaning of     mechanical ventilation.      The main objective is to quantify the loss of diaphragm function by measuring the diaphragm     force (using the non invasive method by phrenic nerve stimulation allowing to measure the     twitch airway pressure during airway occlusion) in a selected population of patients with     critical illness neuromyopathy (defined as a MRC score < 48).      The second end points are to evaluate its incidence, the consequences on the patients outcome     (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm     function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and     diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the     Medical Research Council - MRC score).   "
100637|NCT01968876|"     This research will act as a pilot study that will be conducted to determine the effectiveness     of a smartphone medication adherence application on adherence to oral hypertensive, diabetic,     and dyslipidemic medications using a prospective randomized design. Subjects will be     recruited from the University of Arkansas for Medical Sciences (UAMS) Internal Medicine     Clinic North, and the study data will be collected using only subject self-reports and     subject pharmacy records.   "
100638|NCT01968863|"     The overall objective of this exploratory, laboratory study is to evaluate whether     noninvasive fluorescence microendoscopic imaging of tissue can assist clinicians in detecting     dysplastic (precancerous) areas during standard surveillance. This is a study designed to     evaluate the feasibility of using prototype imaging technology to enhance the detection of     precancerous changes in various tissues. The results of this laboratory study will be used to     further develop the technology for clinical application.      The primary aim of this project will be to investigate what digital image analysis criteria     can be used to best detect dysplasia in various types of resected tissue.   "
100639|NCT01968850|"     This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone     anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30)     treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be     randomized in a 1:1:1 fashion to one of the following three arms:        1. no bone anti-resorptive therapy (standard of care)        2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;        3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D      Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory     evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary     objective will involve calculation of σ and ρ using all data; δ will be estimated by     comparing the two alendronate arms pooled to the no-treatment arm.   "
100640|NCT01968837|"     Although highly curable, cervical cancer kills thousands of women in developing countries     annually. The investigators will pilot a project to improve detection of cervical cancer in     Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise     available in a large medical centre and remote use of a mobile phone camera application.   "
100641|NCT01968824|"     Despite the plethora of literature suggesting that regional blockade provides adequate     andimproved postoperative pain control, function and improved intraoperative and     postoperative safety in proximal upper extremity surgery, little is known of its benefits for     the treatment of forearm and distal radius fractures . The purpose of this randomized,     prospective, study is to determine if brachial plexus blockade with general anesthesia is     superior to general anesthesia alone in immediate and long-term pain control in patients     undergoing operative fixation of distal upper extremity fractures.   "
100642|NCT01968811|"     The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing     Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to     evaluate the dressing kit as part of a negative pressure system. The secondary objectives are     to collect and evaluate safety data, performance data and information on technical     complications.   "
100643|NCT01968798|"     The ASPREE Cancer Endpoint Study (ACES), an ancillary study of the ASPirin in the Prevention     of Events in the Elderly (ASPREE) Study, will allow for the examination of the effect of     daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected     specific incident and recurrent cancer and metastases. The establishment of this ACES biobank     will allow for the exploration of DNA-related molecular mechanisms of aspirin's protective     effect against cancer, cancer associated mortality and metastases, using blood or saliva DNA     specimens, urine, and tumor tissue.   "
100655|NCT01968642|"     The utilization of transthoracic echocardiography in the United States has been increasing.     This has resulted in increased costs to the healthcare system. In an effort to curb excessive     utilization of this technology, the American College of Cardiology created Appropriate Use     Criteria to help guide clinicians to use this diagnostic imaging modality more appropriately.     The investigators previously showed that an educational intervention can reduce the rate of     inappropriate echocardiograms ordered by physicians-in-training. It is unknown if such an     intervention would be successful in attending, staff level of physicians. The investigators     hypothesize that an educational and feedback intervention will reduce the rate of     inappropriate outpatient transthoracic echocardiograms ordered by staff cardiologists and     internal medicine physicians.   "
110881|NCT01834612|"     To determine if a manual blood loss can be detected using the non-invasive blood monitor.   "
100644|NCT01968785|"     The kidneys are an important regulator of blood pressure. Previous research has shown that     disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In     the past, one technique that was used to treat severe high blood pressure was a surgical     procedure to cut these nerves. However, this surgery is no longer commonly performed.      Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a     small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is     currently approved in the United States to deliver ion dose therapy to re-narrowings that     form in the coronary arteries in the heart. This trial is assessing the safety of treating     patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney     to help control blood pressure in patients with uncontrolled hypertension.        1. Renal artery brachytherapy with beta-emitting source is safe.        2. Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood          pressure via renal denervation mechanism within 6 months post treatment.   "
100645|NCT01968772|"     In this pilot study we propose to gather preliminary data on whether transdermal magnesium     chloride can improve quality of life in patients with fibromyalgia. Forty women with     fibromyalgia will be enrolled in this study. Participants will be asked to apply a topical     solution of magnesium chloride on their extremities 3 times daily for 28 consecutive days.     Three questionnaires measuring quality of life will be administered at baseline, at 2 weeks,     and at 4 weeks (end of study).   "
100646|NCT01968759|"     Progressive renal impairment in chronic kidney diseases (CKD) may cause inability to excrete     phosphate load, thus leading to the typical abnormalities of the mineral metabolism, such as     increased phosphate and reduced calcium levels, 1,25- dihydroxyvitamin D deficiency and     secondary hyperparathyroidism (HPT). Treatment with vitamin D analogues and/or phosphate     binders ameliorates these abnormalities that are also associated with accelerated renal     disease progression and increased cardiovascular risk. However in a post-hoc analysis of 331     patients with proteinuric chronic nephropathies included in the Ramipril Efficacy In     Nephropathy (REIN) trial, increasing serum phosphate levels at inclusion, even within the     normal reference range, were associated with an incremental risk of progression to End Stage     Renal Disease (ESRD). Moreover, increasing levels of serum phosphate were associated with a     progressively decreasing protective effect of ramipril therapy against progression to ESRD,     to the point that the benefit of Angiotensin-Converting-Enzyme (ACE) inhibition was almost     fully lost among patients with serum phosphate levels exceeding 4.5 mg/dL. This finding     provided convincing evidence that phosphate plays a direct pathogenic role in patients with     progressive nephropathies and that excess phosphate exposure may limit or even blunt the     renoprotective effect of ACE inhibitor therapy in this population.      Sevelamer carbonate is a newly approved phosphate binder for chronic kidney disease (CKD)     patients not yet on maintenance dialysis. Treatment with Sevelamer, in addition to correct     hyperphosphatemia, was also found to ameliorate abnormalities of the mineral metabolism     associated with accelerated renal disease progression and increased cardiovascular risk.     Moreover, Sevelamer therapy reduces proteinuria in an animal model of uremia, an effect that     in the long term might translate into significant renoprotection. These findings suggest that     serum phosphate might be a specific target for renoprotective therapy in CKD patients and     provide the background for randomized clinical trials to formally test whether reducing     phosphate exposure by phosphate binding agents may serve to optimize the renoprotective     effect of RAS inhibition in this population. Thus, whether phosphate reduction by Sevelamer     carbonate therapy may have a specific antiproteinuric effect in humans with chronic     nephropathies and residual proteinuria despite optimized RAS inhibitor therapy is worth     investigating.   "
100647|NCT01968746|"     The overall objective of this study is to utilize heart rate variability and respiratory rate     variability in patients with sepsis to predict clinical deterioration and death.      Our specific objectives are:        1. To study the ability of a change in composite variability (∆CVI) assessment to act as a          prognostic aid in predicting disease progression in sepsis.        2. To study the effect that standard resuscitation interventions will have on the direction          and magnitude of ∆CVI in patients with sepsis.      B. Hypotheses H1: In the initial resuscitation of sepsis, a low or declining multi-parameter     composite variability index (CVI) over 4 hours will predict a significant increase in the     combined outcome of overt shock, organ dysfunction, and mortality.      H2: In the initial resuscitation of sepsis, low volume fluid resuscitation (<20 cc/kg) over 4     hours will be associated with a low or declining CVI.   "
100648|NCT01968733|"     This study will evaluate the safety and efficacy of an experimental antibiotic,     solithromycin, in the treatment of adult patients with community-acquired pneumonia.   "
100649|NCT01968720|"     The purpose of this study is to determine the safety and efficacy of multiple doses of     CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current     therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total     triglycerides and chylomicron triglyceride levels in patients with severe     hypertriglyceridemia.      This is a single-blind study. All patients will receive placebo for a 14 day treatment period     and CAT-2003 for a 28 day treatment period.   "
100650|NCT01968707|"     The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep     on skin flora of the abdomen and inguinal regions of human subjects.   "
100651|NCT01968694|"     We are doing this research study to find out if intravenous (in your vein, IV) lidocaine     can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved     intravenous lidocaine to treat irregular heart beats, but the FDA has not approved     intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used     for more than 25 years to treat different acute and chronic pain conditions but has not yet     been studied for endometriosis pain.      This is a cross-over trial over two months where one month you will receive the active     medication (lidocaine) and one month you will receive the active placebo (diphenhydramine,     commonly known as benadryl). We will compare the effect on pain from endometriosis of     lidocaine to active placebo.   "
100652|NCT01968681|"     Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally treated     with pulsed dye lasers (PDL); however, around 20 percent of patients are poor responders and     do not get satisfactory results from pulsed dye laser treatments.      Small studies with alexandrite lasers indicate that this may be an alternative treatment for     individuals with nevus flammeus. This study assesses the clinical effect and side effects of     alexandrite laser treatment for nevus flammeus using different treatment settings.   "
100653|NCT01968668|"     This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the     clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive,     double-blind, placebo-controlled, parallel-group design.      Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio     (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline     to Visit 8 (Day 90)   "
100654|NCT01968655|"     To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious     bleeding episode who do not have access to an active clinical study site associated with the     OBI-1-301 study.   "
102803|NCT01940549|"     The purpose of this study is to test whether transcranial direct current stimulation (tDCS)     can enhance the clinical efficacy of trauma-focused therapy for posttraumatic stress     disorder.   "
100659|NCT01968590|"     This clinical trial is conducted by one of 4 locations; University of British Columbia     (Vancouver, CA), University of Utah (Salt Lake City, UT, USA), University of Cincinnati     (Cincinnati, OH, USA), and University of Hamburg (Hamburg, Germany).      Adults with NF1 have a higher risk of osteopenia and osteoporosis, a condition of low bone     density that can lead to fragile bones and bone breakage.      People with NF1 also have lower vitamin D levels than unaffected individuals. Vitamin D is     important for normal bone health, but studies to improve bone health by vitamin D     supplementation in people with NF1 have not been tried.      The purpose of this study is to treat adults with NF1 who have insufficient serum vitamin D     levels with 2 different doses of vitamin D supplementation to determine if vitamin D     supplementation ameliorates the usual loss of bone mineral density over 2 years.   "
100660|NCT01968577|"     Patients with stable coronary disease when undergoing percutaneous coronary intervention may     present periprocedural myocardial infarction defined at present as a creatine     kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off for     periprocedural myocardial infarction after PCI. Although percutaneous coronary intervention     is associated with low rates of complications, periprocedural myocardial infarction has been     touted as a negative factor in long-term clinical results . Several clinical, anatomical and     technical associate to the occurrence of this event . Although randomized controlled trials     and systematic reviews to statin pre intervention have targeted the administration of     high-dose statin is recommended before surgery to reduce the risk of periprocedural     myocardial infarction, there is no information on the impact of the maximum concentration     plasma of statin at the time of percutaneous coronary intervention in stable patients on     chronic statin use in preventing periprocedural myocardial infarction or the elevation of     cardiac enzymes . The anti-ischemic effect of statins in percutaneous coronary intervention     was mainly determined in statin -naïve patients or in patients with acute coronary syndromes     . In this work , we studied the impact of the peak plasma concentration of statin at the time     of percutaneous coronary intervention was studied through prospective randomized single     center in stable patients with chronic statin divided into two groups . In the group (1)     Experimental (n = 268 ) was administered at a dose of 40 mg rosuvastatin between one and six     hours before surgery and group (2) control without rosuvastatin (n = 268). This range 1 to 6     hours is the time at the peak concentration of rosuvastatin in the blood after oral     ingestion. The primary objective was to assess the incidence of periprocedural myocardial     infarction by creatine kinase above three times upper normal limit in hospital period and as     a secondary objective to analyze the elevation of any amount of creatine kinase on the     baseline.   "
100661|NCT01968564|"     The proposed study will assess the ability of curcumin, the active ingredient in the Indian     spice tumeric, to improve the function of arteries with age. Overall, the proposed research     project has the long-term potential to influence clinical practice guidelines by establishing     a novel, easy to deliver, cost-effective therapy for treating age-associated arterial     dysfunction and reducing the risk of cardiovascular disease with age.   "
100662|NCT01968551|"     The primary objective of this study is to evaluate the efficacy of     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose     combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in     virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week     24.      This study consists of 48 weeks of open-label phase followed by an optional Extension Phase     in which all the participants will receive E/C/F/TAF+DRV.   "
100663|NCT01968538|"     Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or     hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances     in omic analysis may offer additional information to the physician about prognosis and     radiation response. We propose to establish a protocol to incorporate omic analysis into the     evaluation and treatment of patients with prostate cancer.   "
100664|NCT01968525|"     1. Every individual receiving a general anesthetic is at potential risk for developing a          ''cannot intubate-cannot ventilate'' situation following anesthetic induction.        2. Building up of oxygen reserves assumes great significance as this provides a longer          duration of non-hypoxic apnea should one be faced with an unanticipated difficult          airway.        3. The main physiological functions of red blood cell hemoglobin are to deliver oxygen to          the peripheral tissues.        4. During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb          while arterial oxygenation and oxyhemoglobin saturation remain high.        5. Previous studies about the duration of non-hypoxic apnoea focus on methods to improve          the safety period of tracheal intubation.        6. To our knowledge, there is no literature about the duration of non-hypoxic apnoea of          anemia patients.        7. The aim of this study was to assess the effect of chronic anemia on the duration of          non-hypoxic apnoea during induction of anaesthesia.   "
100665|NCT01968512|"     Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder     (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the     adaptation of inhibitory control.   "
100666|NCT01968499|"     This registration study aims to investigate the associations of the pharmacogenetic and     pharmacokinetic factors with clopidogrel low response and clinical outcome in patients with     coronary artery disease, and provide new pharmacogenetic and pharmacokinetic targets for the     individualized anti-platelet treatment.   "
100667|NCT01968486|"     To demonstrate the efficacy of ranibizumab in combination with reduced-fluence verteporfin     photodynamic therapy (RF-PDT) in patients with subfoveal choroidal neovascularization     secondary to pathologic myopia (PM).   "
100668|NCT01968473|"     The purpose of this study is to investigate issues relating to comfort and tolerance to     surface neuro muscular electrical stimulation in a parkinson disease population.   "
100669|NCT01968460|"     This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and     rasagiline for the treatment of early Parkinson's disease.      Animal studies support the therapeutic advantage of combining low doses of rasagiline and     pramipexole and suggest further improvement when both are administered in a sustained     fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's     disease with a good safety profile. combining the drugs in low doses and controlled release     may provide better symptom management than the existing drugs alone or together.   "
100670|NCT01968447|"     The purpose of this study is to study the effect of variations in the arterial CO2     concentration during deep neuromuscular block on the surgical conditions as assessed by the     surgical rating scale   "
100693|NCT01968148|"     The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response     after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac     arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased     secretion of insulin and glucose-like peptide 1 (GLP-1).      Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first     sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the     samples.      Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.)     survivors and non-survivors.   "
100671|NCT01968434|"     The purpose of this study is to determine if there is comparable efficacy between     carbocisteine and a protective cough syrup from natural ingredients in children's cough due     to upper respiratory tract infections (URTI) such as the common cold. The hypothesis is that     protecting the throat is very useful in decreasing cough severity, both day and night,     without needing to subdue such an important reflex as cough, and without only acting on     mucous fluidification, especially in children where sedation and excessive fluidification is     dangerous. The research hypothesis is that the protective (GrinTuss) Syrup relieves cough     (frequency, intensity, degree of disturbance due to nocturnal cough, and improves the quality     of sleep of the child) as much as or more than the carbocisteine syrup usually used to treat     children (Syr Mucolyt).   "
100672|NCT01968421|"     Non-cystic fibrosis bronchiectasis is characterized by irreversible dilatation of the     medium-sized bronchi as a result of airway injury due to recurrent or chronic inflammation     and infection. Bronchiectasis airways are often colonized with bacterial species. Infections     of the airways are thought to play an important role in bronchiectasis exacerbation. The     non-specific prevention of recurrent airway infections by immunostimulating agents has gained     growing scientific interest. OM-85, consisting extracts of eight kinds of bacteria important     in respiratory infections, has shown the benefit for significantly reducing the incidence of     exacerbations of chronic obstructive pulmonary disease (COPD). The purpose of this study is     to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese     patients (iPROBE).      This study is designed as a prospective randomised double-blind placebo-controlled     multi-centred trial.   "
100673|NCT01968408|"     AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for     the prevention of nosocomial diarrhea.      TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a     daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery     stools in a 24 h that will occur more than 72 h after admission).   "
100674|NCT01968395|"     The objective of this study is to conduct a population pharmacokinetic analysis of     caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or     liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic     parameters in case of moderate and severe liver dysfunction.   "
100675|NCT01968382|"     Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS     antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters     related to severe alcoholic hepatitis (SAH).      IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids.      Aim: To perform a phase 2a proof of concept placebo-controlled, dose-ranging study of Imm     124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on     steroids.   "
100676|NCT01968369|"     Several epidemiological and intervention studies suggest that a high dietary intake of     tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is     associated with an increased incidence of CVD. This beneficial effects have been attributed     especially to lycopene, an antioxidant present in high concentration within tomatoes but     other substances could be of importance.      Endothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the     present study is therefore to investigate whether consumption of tomato products ameliorates     peripheral endothelial function, triggered by a high fat meal, in human volunteers in a     randomised, crossover dietary intervention study.      Study design:      Investigators are randomising healthy men (N=14-28) to consume a high fat meal either with or     without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the     week before the study all the subjects will be maintained in a low fibers diet and only     subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for     7 days= total load 560 mg).      We hypothesize that tomato sauce can improve the deleterious effects of a high fat meal on     vascular function.   "
100677|NCT01968356|"     The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep     on skin flora of the abdomen and inguinal regions of human subjects.   "
100678|NCT01968343|"     Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and     plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment.     However, there have been no randomized, controlled studies of the efficacy of group     cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a     diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either     group cognitive-behavioral therapy or group supportive therapy (control).   "
100679|NCT01968330|"     This study will be a randomized controlled trial involving obese women obtaining prenatal     care at an obstetric care clinic. Study subjects will undergo prenatal care in a group     setting or prenatal care with a behavioral intervention to improve sleep. Anthropometric     measurements, blood draws, questionnaires and at home sleep studies will be completed at     three specified times (two antepartum and one postpartum). Primary outcome will be a     comparison of postpartum weight loss amongst the intervention and control groups.   "
100680|NCT01968317|"     The purpose of this study is to see if megestrol acetate plus metformin will be more     effective in returning the endometrial tissue to a normal state than megestrol acetate alone     in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.   "
100694|NCT01968135|"     The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive     implants who report a bleeding-spotting episode of at least seven days will stop bleeding     within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to     women receiving 14 days of placebo.   "
100695|NCT01968122|"     The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in     patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high     complication rate in patients in stenting group. However the intravascular therapy is going     on because of low complication rate in considerable Chinese studies coming from several high     volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the     SAMMPRIS study, it is imperative to performing an multiple prospective registry study of     stenting for patients with ICAS in China.   "
100777|NCT01967043|"     This is a standard 3+3 Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181     Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic     or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.   "
100681|NCT01968304|"     In cancerology, anemia is a frequently-found situation, with a prevalence ranging from 30% to     90%, according to the series, disease stages, primary tumor locations and age (Scotte,     Launay-Vacher et al. 2012). Although very probably a major cause of anemia, iron deficiency     (ID) has been seldom investigated in the field of cancer. Its prevalence and incidence have     never been assessed in a prospective study. It is well-known that anemia in the cancer     setting is a source of asthenia and deterioration of quality of life, and can even reduce the     efficacy of anticancer treatments such as radiotherapy. Correcting anemia therefore     constitutes a daily challenge. Before 2004-2005, a very large proportion of patients were     treated with erythropoietin (EPO). However, prescriptions for EPO appear to have considerably     declined since the warnings issued by various scientific societies and governments on account     of the possible increase in death rates and a higher incidence of thromboembolic events, as     reported in 8 studies published to date (NCCN 2012). Simultaneously, the transfusion rate     augmented from 3.4% to 8.7% and the median hemoglobin level fell from 10.8 to 8.9 g/dL     (Feinberg, Bruno et al. 2012). The use of injectable iron appears to have improved the     correction of anemia by EPO, as reported in several concordant studies versus oral iron and     placebo (Pedrazzoli, Rosti et al. 2009; Steensma, Sloan et al. 2011). However, no monotherapy     study has been conducted to evaluate the impact of injectable iron, alone without EPO, for     the correction of ID (with or without anemia) in cancer treatment. Consequently, there exists     a wide variety of practices, with an injectable iron prescription rate which, a priori, does     not match the number of patients with iron deficiency. There exist other iron-based     parameters to characterize ID but these are not yet used routinely during chemotherapy and     need to be validated in the cancer field.      These parameters include:        -  An assay of reticulocyte hemoglobin content (rHC)        -  An assay of soluble transferrin receptor (sTfR) Soluble transferrin receptors are mainly          located on red blood line cells receiving iron delivered by transferrin.      In this study, we propose to make a prospective assessment of the iron status of cancer     patients beginning chemotherapy. The aim is to determine the proportion of patients who might     benefit from injectable iron treatment. All ID will be covered prospectively over a 2-year     period.   "
100682|NCT01968291|"     The purpose of this study was to determine whether use of teach-back discharge instructions     improve patient satisfaction and patients' self-reported and objective comprehension of     discharge instructions in the emergency department when compared to standard discharge     instructions.   "
100683|NCT01968278|"     Oral immunotherapy (OIT) programs for milk, egg and peanut, desensitize patients to their     respective allergens and thereby decrease their risk of morbidity and mortality. OIT     programs, however, are not without adverse events, particularly in highly sensitive patients.     Recently, it has been demonstrated that the administration of baked milk (BM) products to     IgE-CMA patients that are non-reactive to BM, can promote tolerance to unheated milk (UM).     The goal of our research is to determine whether BM can promote desensitization even in the     highly sensitive patient, who reacts to baked milk as well. In a second step, we hypothesize     BM-OIT will promote desensitization to unheated milk, as well.      Importance: The change in the risk/benefit ratio of such a program will alter the therapeutic     approach to an IgE-CMP allergic patient.      Probable implications to Medicine: BM-OIT will allow highly sensitive patients to tolerate     milk products, decreasing their risk of life-threatening reactions. Furthermore, analysis of     the immune modulation parameters that change during the treatment program, should pave the     way for defining mechanisms underlying tolerance in CMP allergy.   "
100684|NCT01968265|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx     in combination with metformin versus placebo + metformin   "
100685|NCT01968252|"     The study is designed to validate the use of speckle-tracking echocardiography to measure     tricuspid annular plane systolic excursion as a measurement of right ventricular function     during transesophageal echocardiography.   "
100686|NCT01968239|"     The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of     ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is     guided by morphological macular changes detected by OCT compared to re-treatment according to     SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of     BCVA).   "
100687|NCT01968226|"     The purpose of this study is to investigate the ability of the compound[F-18]RGD-K5, when     used as a tracer during PET (positron emission tomography) imaging, to detect regions of     unstable atherosclerotic plaque in the carotid artery of subjects being considered for     carotid endarterectomy (CEA),and to confirm this ability through histological studies of     samples of carotid artery plaques that will be collected during the planned carotid surgery.   "
100688|NCT01968213|"     Patients enrolled into this study will be stratified into 3 groups based on gene mutations     identified in their tumor tissue. The purpose of this study is to evaluate patient response     to maintenance treatment with rucaparib versus placebo. Response to treatment will be     analyzed based on homologous recombination (HR) status of tumor samples.   "
100689|NCT01968200|"     Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also     lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi)     and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the     incidence of heart failure (HF).      ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The     main objective is to assess whether enalapril started concomitantly to AC-containing     treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed     to selected patients showing laboratory evidences of injury after chemotherapy, during     follow-up visits in 268 patients.   "
100690|NCT01968187|"     The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097     in children and adults with Prader-Willi Syndrome.   "
100691|NCT01968174|"     Eyelid surgeries change the lid position over the cornea. Previous surgeries evaluated     astigmatic corneal changes in children undergoing ptosis repair. Only several studies     evaluated astigmatic changes following eyelid surgeries in elderly patients. The     investigators aim is to estimate this change, implications on corneal astigmatism may have     great effect to future cataract surgeries for this group of patients.   "
100692|NCT01968161|"     We propose a use of a unique facility, the databank at the CNDV, to examine the impact of     switching subjects to asenapine in an open-label naturalistic setting. This offers the     following advantages: i) providing data on a particularly important population, i.e.,     subjects who are at the inception of treatment for a psychotic disorder and who are likely to     remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting,     with a clinical team dedicated to provide innovative interventions; iii) its naturalistic     design, that will allow to obtain data that will be applicable to real-life clinical     settings; indeed, subjects who will be switched to asenapine within the current project are     those we would switch to this drug in our daily practice.   "
104873|NCT01913418|"     The purpose of this study is to evaluate the efficacy of Suan-Zao-Ren Tang in improving sleep     quality, anxiety, depression, and heroin craving among methadone-maintained persons with     sleep complaints.   "
100697|NCT01968096|"     Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In     parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and     animal studies, histochemical and physiological evidences showed that the paralyzed muscle     transferred from slow, fatigue-resistant to fast, fatigable after injury.      Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using     high load electrical stimulations showed a reverse change of muscular properties, such as     hypertrophy and reversal of fiber type transformations but failed to show a reversal of     spinal circuitry function. Previous studies found that fast continuous passive motion (CPM)     altered the H reflex excitability in human. Animal studies found that passive cycling and     passive stretching delayed atrophy and influenced the transition of type I and IIa MHC.     Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse     both spinal circuitry and muscular properties after SCI but it has not been confirmed in     human study.      The purpose of this project is to investigate the effect of mechanical stimulation by fast     CPM on the reversing adaptation of human paralyzed muscle after SCI.   "
100698|NCT01968083|"     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants     and children. This study will evaluate the safety and immune response to an RSV vaccine in     healthy RSV-naïve children.   "
100699|NCT01968070|"     The main purposes of this study are to evaluate the safety and how well the body handles     single and multiple doses of increasing strength of study drug, LY3127760. This study     includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from     Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last     approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days     prior to enrollment.   "
100700|NCT01968057|"     The purpose of this study is to determine the effects of ciclosporin on the amount of     baricitinib that is absorbed into the blood stream and the time it takes to remove     baricitinib from the body. The study will also look at how well-tolerated and safe     baricitinib is, when given alone and in combination with ciclosporin. Side effects will be     documented. The study will last approximately 6 days from the first dose to the end of the     study (not including screening or follow-up).   "
100701|NCT01968044|"     Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal     impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor     gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term     peirod (52 weeks).   "
100702|NCT01968031|"     This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in     patients with moderate to severe Parkinson's Disease. While on this study, participants will     continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or     Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be     randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per     day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate     the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as     improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in     this group.   "
100703|NCT01968018|"     The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety     of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic     cancer pain.   "
100704|NCT01968005|"     The purpose of this study is to evaluate efficacy, tolerability and safety of     Etoreat®(Etodolac-Lidocaine Topical Patch) in the treatment of acute low back pain (LBP).   "
100705|NCT01967992|"     The study is a pilot, designed to provide data regarding the feasibility and acceptability of     conducting such a study on a larger scale. The present study is a randomized controlled     clinical trial comparing two programs to help people manage diabetes and lose weight, one     using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and     the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle     modifications. Intervention content will include information about nutrition (American     Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group,     emotion regulation, positive affect, and mindful eating strategies.   "
100706|NCT01967979|"     This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts     will evaluate the effects of multiple doses of itraconazole and fluoxetine on the     pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects     will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of     14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In     Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a     wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of     RO5285119 on Day 6.   "
100707|NCT01967966|"     This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability,     pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety     in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed     by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.   "
100708|NCT01967953|"     The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and     recondition lungs from marginal donors has opened a new era in the field of lung     transplantation.   "
100709|NCT01967940|"     Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which approximately 10     participants will be enrolled to receive open-label tenofovir alafenamide (TAF) in addition     to their current failing antiretroviral (ARV) regimen. This cohort will then be followed by a     randomized, double-blind, cohort of approximately 90 participants to compare the addition of     TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen.      In Part 2, all participants who complete Part 1 of the study will discontinue their failing     ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all     participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will     receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet     regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF     who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not     be eligible to continue into Part 2 of the study. All participants who received placebo in     Part 1 will be eligible to participate in Part 2 regardless of their viral load change.   "
100710|NCT01967927|"     To estimate the mean and standard deviation (SD) of the post-treatment decreases in the     interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in     patients with locally advanced squamous-cell carcinoma of the head and neck.      The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid     pressure within the tumors will be measured by assessing the trend and statistical     significance of the difference in values for each condition obtained prior to and just after     GRID exposure in each subject enrolled in the study. We expect that there may be a trend for     increases in tumor oxygenation and decreases in interstitial fluid pressure which would     indicate that more accurately timed additional chemotherapy and radiation therapy would     improve overall patient outcomes.   "
100711|NCT01967914|"     The hypothesis is that plethysmography variability index can predict the occurrence of     hypotension after spinal anesthesia for cesarean delivery   "
100712|NCT01967901|"     Diabetic Kidney Disease (DKD) is becoming a global health concern that affects largely the     elderly population. Despite advances in pharmacological and management strategies, DKD remain     associated with high morbidity and mortality. Patients living with such chronic disease, are     expected, on daily basis to manage their self-care activities. Patients' non-adherence to the     treatment is thought to be the major cause for the poor control and the occurrence of     complications. Previous researchers have shown that multidisciplinary management of chronic     disease can improve patients' self-care and outcomes. However, none of these programs was     centered on self-care and targeted patients with DKD. A multidisciplinary self-care     management program could improve the outcomes of patients with DKD, and delay the progression     of the disease.      The aim of the study is to investigate the effect of a multidisciplinary self-care management     program on self-care behavior, quality of life, medication adherence, glycemic control and     renal function, in adults with DKD.      The study will use a cross-over design. 32 adult with DKD, will be randomly recruited from     the Vaud University Medical Center, nephrology department and will be enrolled in the program     for 12 month. All variables will be measured at baseline, three, six, nine and 12 month. We     will measure the patients' self-care behavior, quality of life, adherence to the     anti-hypertensive medication taking using, the Revised Summary of Diabetes Self-Care     Activities questionnaire, the Audit of Diabetes-Dependent Quality of life questionnaire and     the Medication Events Monitoring System. We will assess the patients' glycemic control by     measuring the glycated hemoglobin and the renal function by measuring the serum creatinine     and the microalbumin creatinine ratio.      The study will clearly show if a multidisciplinary self-care management program will improve     the health outcomes of patients with DKD and will allow us to recommend the establishment of     such a program.   "
100713|NCT01967888|"     The study will be a phase 2/3, multicenter, double-blind, parallel assignment study. It will     involve 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT).      The objective of this clinical trial is to assess whether reparixin leads to improved     transplant outcome as measured by the proportion of insulin-independent patients following     IAT. The safety of reparixin in the specific clinical setting will be also evaluated.   "
100714|NCT01967875|"     The purpose of this study is to determine whether ERCC1(excision repair cross-complementation     1 ) expression has effects on platinum-based chemotherapy for patients with locally advanced     or metastatic gastric cancer, and to explore if ERCC1 can act as a biological predictor for     the individual therapy of gastric cancer   "
100715|NCT01967862|"     This phase II trial studies how well fluorine F 18 sodium fluoride positron emission     tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging     (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging     techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be     more effective than standard CT and bone scan in finding metastatic prostate cancer.   "
100716|NCT01967849|"     The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate)     tolerance in lean children with a family history of diabetes and in overweight/obese children     with or without a family history of diabetes mellitus.   "
100717|NCT01967836|"     The purpose of this study is to see if Glad Press 'n Seal works as a moisture barrier for     central line that is left in place during ambulatory oncology clinical care.   "
100718|NCT01967823|"     Background:      The NCI Surgery Branch has developed an experimental therapy for treating patients with     cancer that involves taking white blood cells from the patient, growing them in the     laboratory in large numbers, genetically modifying them, and then giving the cells back to     the patient. In a previous study the NCI Surgery Branch used the anti-ESO-1 gene and a type     of virus (retrovirus) to make these tumor fighting cells (anti-ESO-1 cells). About half of     the patients who received this treatment experienced shrinking of their tumors. In this     study, we are using a slightly different method of producing the anti-ESO-1 cells which we     hope will be better in making the tumors shrink.      Objectives:      The purpose of this study is to see if these tumor fighting cells (genetically modified     cells) that express the receptor for the ESO-1 molecule on their surface can cause tumors to     shrink and to see if this treatment is safe.      Eligibility:      - Adults 18 years old and older with cancer that has the ESO-1 molecule on their tumors.      Design:        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as          needed        -  Leukapheresis: If the patients meet all of the requirements for the study they will          undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells.          {Leukapheresis is a common procedure which removes only the white blood cells from the          patient.}        -  Treatment: Once their cells have grown the patients will be admitted to the hospital for          the conditioning chemotherapy, the anti-ESO-1 cells and aldesleukin. They will stay in          the hospital for about 4 weeks for the treatment.        -  Follow up: Patients will return to the clinic for a physical exam, review of side          effects, lab tests, and scans about every 1-3 months for the first year, and then every          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2          days.   "
100719|NCT01967810|"     This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in     patients with high-grade glioma. Another purpose of this study is to assess the efficacy,     safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.   "
100720|NCT01967797|"     The main goal of this project is to develop, implement and evaluate the 5As Team intervention     (5AsT)for healthcare practitioners to improve their weight management patient encounters and     improve patient health outcomes. The 5As of Obesity Management suite of tools is a robust,     evidence-based approach to weight management, however its implementation and uptake has been     heterogeneous in primary care.      This project was co-created by, and will be implemented with, our partners the Southside     Primary Care Network (SSPCN). A needs assessment on weight management by the SSPCN revealed     the need to change provider practice to increase the number of weight management visits.     Despite a robust didactic training session on weight management for all providers, which     includes the 5As, the uptake in practice has been highly heterogeneous. Thus, the 5AsT     intervention to address the implementation of the 5As of Obesity Management in clinical     practice was developed by the collaborative team. The SSPCN consists of 25 autonomous groups     of multidisciplinary professionals that provide service to a defined group of patients within     the SSPCN.      The 5As Team consists of multidisciplinary providers (Registered Nurse/ Nurse Practitioner,     dietician, mental health worker) who work collaboratively. The intervention is a learning     collaborative where these 12 different 5AsTs get together to work to address facilitators and     barriers to weight management in their settings over a 6 month period. Half of the teams     (N=12) will remain as controls and deliver usual care. They serve as a comparison group for     the 5AsTs. This mixed methods study's primary outcomes will assess the change in provider     practice and the effectiveness of the intervention and implementation.      To assess the impact of 5AsT on patients, we will recruit patients presenting to the central     SSPCN programming, We will not intervene directly on patients; we will observe the impact of     the 5AsT and SSPCN programming on their health outcomes for a minimum of 6 months, and where     possible for 18 months. Data collected includes demographics, weight (BMI), waist     circumference, vital signs,and Short Form-12 (SF-12,these measures are routinely measured in     the SSPCN), EuroQol-5 dimensions 5 Level (EQ-5D-5L), modified patient assessment of chronic     illness (PACIC), and observed adherence to routine clinical care for guideline recommended     laboratory monitoring (cholesterol panel, fasting glucose, HbA1c, where appropriate).   "
110882|NCT01834599|"     To assess the potential of the cerebral oximeter to measure placental oxygenation   "
100721|NCT01967784|"     The aim of the study is to describe the immunogenicity and safety of the new formulation of     Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH)     in subjects aged 9 to 17 years in Taiwan      Primary Objective:        -  To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal          formulation      Secondary Objective:        -  To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation   "
100722|NCT01967771|"     This study will be a phase I, open label, three period, fixed sequence crossover study to     evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of     Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening     visit within 30 days prior to the first dose of study drug, three treatment periods, and a     follow-up visit 7-14 days after the last dose of study drug. There is no washout between     treatment periods.   "
100723|NCT01967758|"     This is a study for patients with brain tumors called astrocytic tumors. The study will     enroll patients who have received standard treatment. The study will test a vaccine called     ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if     ADU-623 can be given safely to brain cancer patients and what is the better dose to give     patients among the three doses that planned to be tested. This study will also evaluate the     length of time before patients' cancer worsens and if ADU-623 helps patients to live longer.     The study will also measure the body's immune system response to ADU-623.   "
100724|NCT01967745|"     Comparison of open and laparoscopic appendectomy   "
100725|NCT01967732|"     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile     (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the     PK profiles from a single use of a conventional cigarette (CC) and from a single use of     nicotine nasal spray (NNS).   "
100726|NCT01967719|"     The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and     amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to     a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).   "
100727|NCT01967706|"     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile     (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS)     compared to the PK profiles from a single use of a menthol conventional cigarette (mCC) and     from a single use of nicotine replacement therapy gum (NRT).   "
100728|NCT01967693|"     Retrospective analysis of data from patients with laryngeal contact granulomas in order to     identify possible differences and/or similarities between the cases and in order to determine     whether and which conclusions can be drawn on disease and therapy.   "
100729|NCT01967680|"     Background: Every year 30,000 Danish patients are admitted to Intensive Care Units (ICU),     accounting for 2-3% of all patients in hospital and 30% of the yearly hospital expenditure.     The mortality in the ICU is 12.7 % and the 30-day mortality is 21.2 % according to the     national Danish Intensive Care Database. Through many years, the standard care has been to     use continuous sedation of critically ill patients during me-chanical ventilation. However,     recent research indicates that it is beneficial to reduce the sedation level in these     patients. A randomised trial found that continuous sedation with a daily wake-up trial     compared to continuous sedation reduced the time on me-chanical ventilation and the length of     stay in the intensive care unit. Further, a ran-domised trial comparing continuous sedation     with a daily wake-up trial to no sedation found that patients in the non-sedated group needed     mechanical ventilation for a shorter time and had a shorter length of stay in the ICU and in     the hospital. The trial also indicated a beneficial effect on mortality, however the trial     was not a priori de-signed or powered with respect to mortality. No randomised trial has been     published comparing sedation with no sedation, a priori powered to have all-cause mortality     as primary outcome.      Objective: To assess the benefits and harms of non-sedation versus sedation with a daily     wake-up trial in critically ill patients in ICU.      Design: The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group,     multinational, superiority trial designed to include 700 patients from at least six ICUs in     Denmark, Norway and Sweden.      Inclusion criteria: Mechanically ventilated patients with expected duration of me-chanical     ventilation > 24 hours.      Exclusion criteria: non-intubated patients, patients with severe head trauma, coma at     admission or status epilepticus, patients treated with therapeutic hypothermia, patients with     PaO2/FiO2<9 where sedation might be necessary to ensure sufficient oxygenation or place the     patient in prone position.      Experimental intervention: Non-sedation supplemented with pain management during mechanical     ventilation.      Control intervention: Sedation with a daily wake-up trial.      The primary hypothesis is that non-sedation compared to sedation and a daily wake-up trial     will reduce mortality.      The secondary hypotheses are that non-sedation compared to sedation and a daily wake-up trial     will:        -  Reduce the incidence of a composite outcome of death, acute myocardial in-farction          (AMI), stroke, pulmonary embolism and other thromboembolic events.        -  Reduce the number of organ failures.        -  Increase the days alive without mechanical ventilation.        -  Increase the days alive outside the ICU.        -  Increase the days alive outside the hospital.      Outcomes: The primary outcome is all-cause mortality at 90 days. Secondary out-comes are time     to death in the trial period, the frequency of the trombo-embolic com-plications, acute renal     failure, days alive without mechanical ventilation, days alive outside the ICU and hospital.     Explorative outcomes are mortality at 28 days, organ failure and coma-free, delirium-free     days.      Trial size: The investigators will include 700 participants (2 x 350) in order to detect or     reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II     error risk of 20% (power at 80%).   "
100730|NCT01967667|"     Low levels of antioxidant molecules such as glutathione have been found in people with a     diagnosis of schizophrenia. However, oral glutathione is not well absorbed because the     compound is mostly broken down in the gastrointestinal system. Liposomes are tiny droplets of     oil particles that encapsulate and protect the glutathione. In this study we will evaluate a     liposomal formulation of glutathione for tolerability and to examine if this formulation     serves the function of increasing glutathione in the brain and body.   "
100731|NCT01967654|"     Vietnam has a smoking prevalence that is the second highest among South East Asian countries     (SEACs). With a population of approximately 90 million, Vietnam also has the second largest     total number of adult smokers (over 16 million) in SEA. According to the World Health     Organization (WHO), most reductions in mortality from tobacco use in the near future will be     achieved through helping current users quit. Tobacco use treatment, as defined by the U.S.     Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is     evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of     recommended care is suboptimal. The objective of this proposal is to fill the current     research-to-practice gap by conducting a randomized controlled trial that compares the     effectiveness and cost effectiveness of two practical and highly replicable strategies for     implementing evidence-based guidelines for the treatment of tobacco use in public health     clinics in Vietnam. The proposed implementation strategies draw on evidence-based approaches,     and the WHO's recently released guidelines for implementing Article 14 of the Framework     Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed     by the WHO in response to the globalization of the tobacco epidemic. Vietnam ratified the     FCTC in 2004; however, they have not taken steps to implement Article 14 which specifies the     need to integrate best practices for treating tobacco use and dependence into routine     preventive care. The proposed implementation strategies also build on the growing literature     that supports the effectiveness of integrating community health workers as members of the     health care team to improve access to preventive services.   "
100732|NCT01967641|"     In this study, we will assess opioid self-administration in a laboratory setting in persons     with pain who have a history of opioid abuse. Participants diagnosed with mild to moderate     pain will be admitted to hospital for 7 weeks and transitioned from their baseline     prescription opioid to a standing daily dose of Suboxone (buprenorphine/naloxone     combination). During this maintenance period, participants will have the opportunity in a     laboratory setting to self-administer oxycodone; subjective responses as well as analgesic,     physiological and performance effects will be measured. In the second phase of this study,     the same patients who participated in the inpatient phase will be followed on an outpatient     basis while maintained on Suboxone for 12 weeks. . The hypotheses of this study are that (1)     higher progressive ratio break-point values for oxycodone, higher subjective ratings of     euphoria, and less pain relief will predict early relapse to opioid abuse; (2) the abuse     liability measures will be more strongly correlated with relapse than the pain measures; (3)     subjective ratings of euphoria will increase and of pain will decrease in an oxycodone     dose-dependent manner (i.e. euphoria will increase and pain will decrease as dose increases);     and (4) experimentally induced pain will decrease in an oxycodone dose-dependent manner.   "
100733|NCT01967628|"     For most individuals, the lung has a remarkable ability to deal with exposure to a variety of     inhaled bacteria. Some individuals, however, do have recurrent bacterial infections, usually     in the form of acute or chronic bronchitis and, in some instances, pneumonia. The reasons for     this variability in bacterial infections between otherwise healthy subjects, between types of     lung disease, and within the same type of lung disease are poorly understood.      Variability in susceptibility to bacterial infections is partially explained by differences     in exposure to infectious agents, genetic susceptibility and innate (or early) immune     responses. It is of interest that the incidence and severity of bacterial infections is     greatest during the winter months. Other than viral infections, there are few variables that     change with season. Vitamin D is one known immune modulator with a seasonal periodicity. The     hypothesis of this study is that levels of vitamin D are an important determinant of the     innate defense of the lung against inhaled bacteria. The investigators further postulate that     vitamin D has effects on the innate immune function of both alveolar macrophages and lung     epithelial cells.   "
100734|NCT01967615|"     Prasugrel and ticagrelor were both associated with a significant reduction in the risk of     MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The     1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients     receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of     biologically active stent (DES or BVS) thrombosis is largely variable according to     different lesion settings. We aim to verify the translation of the postulated different     reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and     ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating     lesions.   "
100735|NCT01967602|"     The goal of this project is to find a marker expression that the investigators can use to     trace symptom progression and develop a more efficient therapy to enhance ARDS patient     survival rate and better post-ICU life quality.   "
100736|NCT01967589|"     This trial is conducted in Europe. The aim of the trial is to investigate safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a     long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.   "
100737|NCT01967576|"     Background:        -  Most treatments for malignant pheochromocytomas/paragangliomas (PHEO/PGL) are palliative          and multidisciplinary. Chemotherapy using the combination of cyclophosphamide,          vincristine, and dacarbazine has been successfully utilized in the management of rapidly          progressive metastatic PHEO, with more than 50% complete or partial tumor response and          more than 70% complete or partial biochemical response.        -  VEGF expression and evidence of angiogenesis has been found in many PHEO/PGL, so it is          plausible that interfering with VEGF signaling may result in anti-tumor activity in          patients with PHEO/PGL.        -  Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial          growth factor (VEGF) receptors 1, 2, and 3. Pre-clinical data suggests that the          anti-tumor activity of axitinib may result from its anti-angiogenic activity and that          this is reversible when treatment is discontinued.        -  Given the known clinical safety and efficacy of axitinib, an assessment of its activity          in PHEO/PGL and its impact on the VEGF pathway in PHEO/PGL could provide valuable          information.      Objectives:        -  Determine the response rate of metastatic PHEO/PGL to axitinib (AG-013736).        -  Determine the progression-free survival of metastatic PHEO/PGL treated with axitinib          (AG-013736).        -  Explore the relationship of potential biological markers of axitinib activity with          clinical outcomes.        -  Perform pharmacogenomics analyses of drug metabolism and transport proteins through          germline DNA examination.      Eligibility:        -  Adults with a confirmed pathologic diagnosis of PHEO/PGL by the Laboratory of Pathology,          NCI        -  Biochemical evidence of PHEO/PGL        -  Imaging confirmation of metastatic, locally advanced or unresectable disease.        -  Measurable disease at presentation        -  ECOG performance status less than or equal to 2        -  Patients must not have received prior therapy with a tyrosine kinase (TK) inhibitor      Design:        -  Phase II, open label, non-randomized trial        -  Patients with metastatic pheochromocytoma/paraganglioma will receive axitinib (AG-          013736 BID) in eight-week cycles        -  Patients will be evaluated for response every eight weeks using RECIST criteria        -  Tumor biopsies are not mandatory but every attempt will be made to obtain these from          patients prior to starting axitinib and again 20 -30 days after treatment has begun.        -  Approximately 12 to 37 patients will be needed to achieve the objectives of the trial   "
100738|NCT01967563|"     Background:      - Popular weight loss plans often restrict carbohydrates or fat. Research shows that     very-low-carbohydrate (ketogenic) diets lead to greater weight loss than low-fat diets.     Researchers want to know if eating fewer carbohydrates changes the number of calories the     body uses. They also want to know how a ketogenic diet affects hunger, hormones, and food     preferences.      Objectives:      - To better understand how the body responds to different diets.      Eligibility:      - Men 18 to 50 years old who are healthy but overweight.      Design:        -  Participants will have 3 screening visits:             1. Medical history, physical exam, blood test, and EKG. They will eat during the               visit.             2. For the week before the visit, participants will wear physical activity monitors               daily. They will record everything they eat and sample the special diet. At the               visit, they will receive an EKG and heart rate test while biking for 30 minutes.             3. For the week before the visit, participants will wear the physical activity               monitors. They will eat all their meals from the special diet that will be               provided. At the visit, they will answer questions and bike for 60 minutes.        -  After screening, for 1 week, participants will visit the clinic daily to receive that          day s food. They will not eat or drink anything else except water.        -  Then participants will stay at the clinic for 8 weeks. They cannot leave but can have          visitors. Participants will wear physical activity monitors, bike daily, and follow          different diets. Tests will be given daily, and may include weighing, X-rays, and blood          and urine tests. They will spend several days in a monitored room to test oxygen and          carbon dioxide.   "
100740|NCT01967537|"     Background:      - Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The     only treatment for NETs is surgery, but most are found when they are too advanced for     surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can     be successful. They want to test if the study drug can be used along with imaging devices to     detect NETs.      Objectives:      - To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown     primary and metastatic NETs in the gastrointestinal system and pancreas.      Eligibility:      - Adults over 10 years old with a suspected NET or family history of NET.      Design:        -  Participants will be screened with a medical history and physical exam, and have a blood          test.        -  Participants will undergo three scans. For all of these, a substance is injected into          their body, they lie on a table, and a machine takes images.      <TAB>- A standard CT scan of the chest, abdomen, and pelvis.      <TAB>- An octreotide scintigraphy SPECT/CT.      <TAB>- A 68Gallium-DOTATATE PET/CT. The study drug is injected into a vein, usually in the     arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device     takes images of the body. The entire session takes 90 to 120 minutes.        -  Researchers will compare images from the three scans.        -  Participants will have 1 follow-up visit each year for 5 years. At this visit, they will          have a medical exam, blood taken, and a CT scan.   "
100741|NCT01967524|"     Myofascial pains are frequently found during the clinical examination of the patients     presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology     of this component of the pain characterized by triggerpoints found in the clinical     examination, remains uncertain; its coverage contributes to the improvement of the global     pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed     injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these     triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent     fibers) but are they superior to the injections of local anesthetics of triggerpoints? The     literature remains poor on the subject, justifying this randomized double-blind protocol     comparing the efficacy of the botulinum toxin associated with a local anesthetic versus local     anesthetic alone with a main criterion of evaluation in 2 months and a monthly follow-up as     long as the patient remains improved and maximum in 6 months.   "
100742|NCT01967511|"     The purpose of this study has evolved and expanded since its inception. Originally the intent     was to establish the functional, molecular and genetic profile of fibroblasts from     Fibromuscular Dysplasia (FMD) patients as compared to carefully matched control subjects.     While this remains among the objectives, the study has been expanded to undertake a fully     powered cross-tissue systems genetics analysis of FMD, and now also the related     arteriopathies spontaneous coronary artery dissection (SCAD) and cervical artery dissection     (CvAD). The overall objective is to disclose the core biologic mechanisms of these disorders.   "
100743|NCT01967498|"     The purpose of our double-blind, placebo controlled study is to test the hypothesis that     montelukast therapy might be associated with improved hearing in certain sub populations of     children suffering from OME.   "
100744|NCT01967485|"     The purpose of this study is to determine if an individualized text messaging intervention     for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in     improving medication adherence and disease management.   "
100745|NCT01967472|"     The aim of this study is to address this gap in knowledge by measuring the level of patient     adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to     artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key     factors that influence adherence. This will be addressed through a mixed methods study that     will provide not only a measurement of adherence ACTs and malaria test results, but will also     provide contextual information in order to better understand factors that affect adherence.     Data will be collected through a series of interviews with health workers and     parents/caregivers and through observations of patient-provider consultations.      The first stage of the study begins with semi-structured interviews and observations of     patients/caretakers' consultations with health workers and will look at how health workers     diagnose and treat malaria. This will be followed by short exit interviews at the health     facility with caregivers to assess patient satisfaction with services, as well as to test the     consistency between the data obtained through structured observations and the exit     interviews.      Follow-up surveys at the homes of patients will be used to measure and compare the adherence     of participants to two different ACTs (AQAS and AL) formulations and potential factors that     affect adherence. Additionally, data will be collected using in-depth interviews to collect     supplementary information in order to discover, in more detail, factors that may affect     behavioral choices and/or attitudes with regard to adherence.   "
100746|NCT01967459|"     Administration of vitamin D will have a beneficial effect on postprandial leukocyte     activation, oxidative stress and arterial stiffness in vitamin D deficient females. High     doses of vitamin D may have a more pronounced effect than low doses.   "
100747|NCT01967446|"     The Investigators hypothesize that functional status scores in elderly women undergoing     surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have     returned to baseline at 12 weeks post-operatively.      The Investigators hypothesize that greater co-morbidity, frailty and worse functional status     before surgery are associated with slower functional recovery, prolonged length of stay in a     hospital or nursing care institution and greater post-operative complications following     surgery for pelvic organ prolapse.   "
100748|NCT01967433|"     To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce     the amount of standard sedatives used during colonoscopy in patients on chronic opioids.   "
100749|NCT01967420|"     This study aims to look at the effectiveness of a combination of cognitive remediation and     social cognition training to improve cognition and functioning when compared to cognitive     remediation alone. The target population will be those who are experiencing their first     episode of psychosis.   "
100750|NCT01967407|"     The aim of the study is the evaluation of the ablation efficiency of the percutaneous     irreversible electroporation (IRE) as primary ablation therapy of locally confined renal cell     carcinoma (≤4cm, see inclusion and exclusion criteria).      The ablation success will be proofed by magnet resonance imaging (MRI) and histologically     after partial kidney resection or nephrectomy 4 weeks after IRE. Hypotheses: Kidney tumors     ≤4cm can be ablated completely by percutaneous IRE. Surrounded structures and renal tissue     can be preserved.   "
100751|NCT01967394|"     Approximately 400,000 live births occur to adolescents in the United States annually. Of the     50% of adolescent mothers who experience depressive symptoms, less than 25% comply with     referrals for depression evaluation and treatment due to lack of knowledge of depression     symptoms (literacy), negative attitude towards mental health treatment, perception that     individuals with depression are stigmatized (subjective norms), lack of understanding of     health resources that are available to her and under her control (perceived control), and     lack of time. Social media is a promising vehicle to reach and educate adolescent mothers     since most adolescent mothers use social media for communication and to search for health     information. Based upon the Theory of Planned Behavior, the investigators will target 11     counties in Kentucky with a social media ad campaign that will result in adolescent mothers     (n=140) from those counties enrolling in an internet based intervention related to postpartum     depression. The previously tested intervention includes vignettes from other adolescent     mothers, questions and answers, resources, and an option to enroll in text message service.     Before the intervention, after the intervention, and two weeks later the adolescent mothers     will complete established questionnaires to determine if the intervention improved attitude     and subjective norms towards depression and depression treatment, perceived control and     intention related to seeking depression treatment, and the number of adolescent mothers with     symptoms of depression who receive depression treatment. Data will be compared to scores on     the same instruments from adolescent mothers (n=140) from the control group (18 other     counties in Kentucky) that have not been targeted with the social media ad campaign or     participated in the intervention. Data from the adolescent mothers in the control group will     be collected in partnership with community agencies. The overall purpose of this trial is to     test a cost effective and feasible method for reducing the cognitive and emotional barriers     to accessing depression treatment in adolescent mothers. The specific aims are to (1) measure     the extent to which a social media ad campaign is effective as a recruitment strategy; (2)     test the effectiveness of an internet based social marketing intervention on both intention     to seek treatment and rates of depression treatment, and (3) examine the dose effect of the     intervention.   "
100752|NCT01967381|"     The research proposed in this application will determine the initial efficacy, safety and     tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a     pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human     laboratory study will be conducted. The proposed study is innovative and important because it     will provide the impetus for the conduct of double blind, placebo-controlled trials to     further demonstrate the efficacy of combined oxazepam and naltrexone for managing     methamphetamine dependence.   "
100753|NCT01967368|"     Influenza is associated with significant morbidity and mortality. Institutionalized older     adults (age>65) is the group associated with highest risk of complications. Influenza     vaccines are the cornerstone of influenza prevention but one systematic review has found that     there is no statistically significant difference against laboratory confirmed influenza. A     major reason is immune senescence in older adults which result in weaker response towards     vaccines when compared with young adults. Intradermal administration of vaccine has been     suggested to improve immune response due to the abundance of immunostimulatory cells, such as     dendritic cells in the dermis. Intradermal administration of influenza vaccine has been shown     to have comparable or superior efficacy compared with intramuscular administration in the     >60-year old population and the rates of adverse events post-vaccination were also comparable     between them. The immunogenicity of intradermal administration has also been shown to be     better in immunocompromised patients, including community dwelling older adults. In addition,     intradermal vaccination has good acceptability and safety profile in different countries, so     it has been licensed in Hong Kong and worldwide. However, there is little study regarding the     efficacy of intradermal vaccination of influenza in institutionalized older adults,     investigators therefore would like to perform a prospective, randomized study to compare the     safety and immunogenicity between conventional full dose intramuscular immunization and full     dose intradermal immunization of the trivalent influenza vaccine in institutionalized older     adults.      The hypothesis is that full dose intradermal trivalent influenza vaccination is as effective     as full-dose standard intramuscular injection in terms of seroconversion and seroprotection     rate in institutionalized older adults. Finding of this study will be important in the     vaccination of institutionalized older adults and immunocompromised patients as intradermal     vaccine may induce a better immune response against influenza infection.   "
100754|NCT01967355|"     Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause     of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not clear     and the only therapy is preterm caesarean section. In severe preeclampsia an accumulation of     triglyceride-rich lipoproteins occurs. Therefore, lipid apheresis is performed as     lipid-removing therapy for treatment of preeclampsia in order to prolong pregnancy and     provide the fetus more time for maturation. In this individual treatment patients with early     preeclampsia (<= 32 weeks of gestation) will be offered a H.E.L.P.-apheresis to postpone     caesarean section and therefore prolong pregnancy.   "
100755|NCT01967342|"     Chronic pain is a significant public health problem that affects over 116 million Americans,     costs $600 billion annually, and is unequally borne by people in low-income brackets,     especially ethnic minorities. Many individuals also have health literacy deficits (difficulty     understanding their illness and difficulty navigating the health care system for treatment)     putting them at a greater disadvantage. Treatment usually relies on expensive medical     interventions that often have negative side-effects. Psychosocial treatments, like Pain     Education and Cognitive-Behavioral Therapy (CBT), show promise, but are usually unavailable.     Clinicians are poorly equipped to provide psychosocial treatments to patients with low health     literacy. CBT has not been adapted and supported for use in individuals with low health     literacy, and even educational materials are often poorly adapted for their needs.      To address this problem, the PI completed a small trial showing benefits from health     literacy-adapted pain education and CBT groups for chronic pain in a population with low     income and low health literacy. Patients in both treatments reported lower pain by the end of     treatment, and the effects were maintained at one year. Patients in the CBT group also     reported less depression. The current study uses a larger sample, and directly compares these     psychosocial treatments to medical treatment-as-usual to seek better evidence for or against     their widespread use in community settings.      Our research questions:        1. In people with chronic pain and low income and/or low literacy, does participating in a          health-literacy-adapted psychosocial treatment improve their pain and interference in          daily activities due to pain by the end of treatment when compared with a group          receiving typical medical care, and are these effects maintained 6 months later?        2. Does participation in the CBT pain management group improve symptoms of depression          better than a pain education group by the end of treatment, and are these effects          maintained 6 months later?      In partnership with a federally qualified health center, we will enroll 294 patients with     chronic pain. Main outcomes will be patient-reported pain intensity, pain interference,     depression, and perceived change. From an earlier trial, we expect that our participants will     be ~75% female and ~70% African American, and will have low literacy and low income (~60% in     the low 15% nationally on word reading, and 90% at or below the poverty threshold).   "
100756|NCT01967329|"     The CANHelp Working Group Treatment Trials are part of a comprehensive research program     carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group. The treatment     component involves a series of community-specific trials designed with community input and     varying on the specific treatment regimens and number of treatment arms among other study     details.   "
100757|NCT01967303|"     Our study aimed to examine a possible association between Restless legs syndrome and     cerebrovascular disease, by examining patients during hospitalization for acute stroke or     transient ischemic attack, in a matched case-control design.   "
100758|NCT01967290|"     The objective of this study is to determine the impact of vibratory feedback on the quality     and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in     stroke patients. For that purpose the investigators use the SWORD system that combines 3D     motion quantification wearable sensors and a vibratory module.      The investigators hypothesize that vibratory stimuli during a motor rehabilitation task     increase significantly the number of correct movements performed per unit of time.      The design of the study is a cross-over randomized clinical trial. With the SWORD system in     place each patient will perform the hand-to-mouth task twice (with vibratory feedback and     without it), the order being random. The number of correct movements and other motor outcomes     will be assessed continuously under both conditions.   "
100759|NCT01967277|"     This study will acquire data on hair growth of the head that is the result of treatment with     a non-heat generating, laser product. This data will come from counting of terminal hairs     before treatment begins and after treatment is completed. The treatment regime is every other     day for 16 weeks.   "
100762|NCT01967238|"     In order to produce better more effective vaccines, it is important to understand the     particulars of why individuals have an effective or ineffective immune response to     vaccination. We are going to examine specific aspects of the antibody (IgG Fc glycan) made by     healthy volunteers who receive different vaccines or who have a viral infection to understand     the nature of an effective (or less effective) vaccine response. The results of this research     could be used to develop adjuvants to increase/ improve vaccine response.   "
100763|NCT01967225|"     The aim of this study is to see the safety and efficacy of BAY1192631 when it is used for the     treatment of skin and soft tissue infections (SSTI) or SSTI-related bacteremia.   "
100764|NCT01967212|"     The purpose of this study is to determine whether swallowing training combined with     game-based biofeedback is effective in the treatment of dysphagia due to stroke.   "
100765|NCT01967199|"     The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting     balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon     expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug     eluting stent restenosis.   "
100766|NCT01967186|"     Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results     are however hampered by a relatively low number of islets surviving the transplantation into     the liver, which currently is the site for transplantation. In the present study we compare a     new transplantation site (intramuscular in the arm) to the golden standard (the liver) in     patients undergoing kidney transplantation from the same donor. In half of the intramuscular     transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient     to, possibly, improve the immunological aspects of the transplantation.   "
100767|NCT01967173|"     The purpose of this study is to find the best asthma treatment to add for Blacks who have     asthma that is not well controlled on a low dose of inhaled steroid. This study will also try     to find out if Black adults and children differ in how they respond to the medications used     in this study.   "
100768|NCT01967160|"     A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and     Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden,     Denmark and Norway.   "
100769|NCT01967147|"     The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over     Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry     eye subjects with lipid deficiency.   "
100770|NCT01967134|"     This is a Phase I, open-label, dose-escalation study with three study groups. This study will     be conducted in 25 HIV negative subjects, 17 of whom will have LTBI and 8 of whom will not     have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of     H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500     nmol KLK (50/500). The vaccine is administered by intramuscular injection.   "
100771|NCT01967121|"     The purpose of this research study is to determine if the application of ice, control group,     or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed     muscle soreness from performing leg extension and flexion. Individuals will complete a health     history questionnaire to determine if they qualify for this study. We will measure your leg     girth with a measuring tape and take a pain measurement of your hamstrings by using a spring     to press down on your leg. Individuals will then warm-up on a bike without resistance for 5     minutes followed by 10 regular leg extension and flexion exercises. Individuals will then     perform 6 sets of 10 leg extension and flexion exercises on a biodex machine (similar to leg     curl machines in the gym). Individuals will perform each set to the maximum effort of their     capables. After each set of 10 individuals will have a 2 minute rest. We will ask you to rank     your leg soreness on a scale from 1-10.      Individuals will then be assigned to a modality of either ice, control group or compex.     Individuals will perform the modality (ice, control, compex) we assign you to until you are     no longer sore.      Over the next five days individuals will return to measure their level of soreness, leg girth     and pain pressure.      This study will examine the following hypotheses:      H1: There will be no difference in pressure pain threshold after using the Compex compared to     other groups.      H2: There will be no difference in perceived soreness after using the Compex compared to     other groups.      H3: There will be no difference in muscular strength after using the Compex compared to other     groups.      H4: There will be no difference in active range of motion after using the Compex compared to     other groups.   "
100772|NCT01967108|"     The purpose of this study is to examine the efficacy of chest physiotheray treatment in     preventing pulmonary complications and weaning faliure, in extubated critically ill patients.   "
100773|NCT01967095|"     The purpose of this study is to test the safety of different ways of taking erlotinib. The     investigators want to find out what effects, good and/or bad, combination daily low dose and     twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are     also seeing whether different schedules of erlotinib are better at treating lung cancer that     has spread to the central nervous system.      CNS expansion phase:      The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers     and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly     diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the     expansion cohorts will undergo the same treatment plan as the patients in the dose expansion     cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish the     first 28 day (cycle 1) treatment period.   "
100774|NCT01967082|"     Objectives:      The specific aim is to investigate the following objectives:      Objective 1.1: Develop a prototype of the APPSPIRE (phone app of a smoking prevention     interactive experience).      This objective will not involve any data analysis. Objective 1.2: At post assessment,     students enrolled in the study will qualitatively provide information about the usability and     usefulness for the prevention and cessation sites.      Objective 2.1: Investigate frequency of use of and exposure to APPSPIRE modules via an     objective measure of general use.      Objective 2.2: Investigate how feasible the program will be. Feasibility will be     operationalized for this objective. Objective 2.3: Obtain a maintained use of APPSPIRE with     high completeness and extent of completion.      Objective 2.4: Evaluate change in stage of change from baseline to about 1 and 4-month     follow-ups among participants.   "
127239|NCT01619605|"     The purpose of this study was to investigate the utility of serum tryptase for the     confirmation of shrimp-induced anaphylaxis.   "
100778|NCT01967030|"     The goal of the Study of Women, Infant Feeding and Type 2 Diabetes after GDM pregnancy     (SWIFT) is to determine whether exposure to prolonged, intensive lactation, as compared to     formula feeding, reduces the 2-year incidence of type 2 diabetes mellitus among 1,035 women     with a recent GDM pregnancy. The study will also examine whether lactation intensity and     duration have persistent favorable effects on blood glucose, insulin resistance, weight gain,     change in waist circumference, and adiposity during the two-year postpartum period. SWIFT is     a prospective, longitudinal observational study in women at high risk for conversion to     diabetes and prediabetes during midlife.   "
100779|NCT01967017|"     Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive     IUDs secondary to the pain associated with insertion. Nulliparous women may be especially     susceptible to procedure-related pain from IUD insertion. This study will investigate the     difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo,     among women who have not had a vaginal delivery before. The investigators anticipate that     among women who have not had a previous vaginal delivery, the pain associated with IUD     insertion will be significantly decreased after administration of local anesthesia.   "
100780|NCT01967004|"     The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead     to greater prosthesis function and control. Subjects are asked to perform specific tasks and     actions using the traditional control method, as well as RFID control.   "
100781|NCT01966991|"     This study will explore how maternal plasma circulating cell free DNA (ccfDNA) can be used as     a primary screening test for Down syndrome as part of routine clinical care in the general     pregnancy population. Plasma ccfDNA testing is currently recommended only for use as a     secondary screen for 'high-risk' women (i.e., women whose risk factors for trisomy make them     candidates for invasive testing such as chorionic villous sampling or amniocentesis). Because     most women in this 'high-risk' category are carrying unaffected fetuses, many 'unnecessary'     procedures are completed in order to identify the few women whose fetuses have a chromosomal     disorder. This creates expense, anxiety, and most importantly, loss of unaffected fetuses due     to procedure related miscarriage. Plasma DNA testing is now being used to reduce     significantly the number of women with unaffected fetuses undergoing invasive testing.      Applying such testing as a 'first-line' screen has not been well-explored, despite calls from     several clinical professional societies to do so. The investigators intent is to introduce,     under carefully monitored conditions, ccfDNA testing through Rhode Island primary prenatal     practices to the general pregnancy population. Education/orientation of prenatal care     providers, their staffs, and their patients will be carefully orchestrated, and     implementation issues identified and addressed. Telephone surveys of consented patients will     elicit responses to their understanding of the test, their satisfaction with the process, and     a comparison of their experience with serum screening in a prior pregnancy. Knowledge gained     from this study will help validate new screening paradigms involving ccfDNA testing. The     study is not designed to estimate Down syndrome detection rates with any confidence, but can     provide information on uptake rates, failure rates, screen positive rates, and the     decision-making of women with positive test results.   "
100782|NCT01966978|"     The aim of this clinical trial is to assess and compare the effect of insulin detemir in     combination with liraglutide and metformin versus insulin detemir in combination with insulin     aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c > 10%).   "
100783|NCT01966965|"     This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the     treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the     infestation, along with the people in your family life. All will be submitted to the dosing     regimen recommended in the package insert. 100% of the sample shall be subjected to clinical     evaluation through comb, pre and post treatment and monitored after thirty days for     evaluation of safety and possible adverse effects that may arise related to any of the     components of the formula.      The efficacy study is active comparator, non-inferiority.   "
100784|NCT01966952|"     Renal sympathetic radioablation disrupts the nerves by high radiofrequency signal which     creates localized heat, eliminates the signal and decrease blood pressure.      The main purpose of this study is to evaluate blood pressure 12 months after radioablation,     and to evaluate the short and long-term effects of the renal radioablation on the extent of     changes in urine catecholamines level, vascular stiffness, and sympathetic nerve activity as     linked with the changes in blood pressure. The study will also evaluate the effect     radioablation has on the renal arteries as well as develop teaching sessions for family     physicians and other specialists to educate them on this new treatment.   "
100785|NCT01966939|"     There are two purposes on this study:      - to investigate the effect of craniectomy and craniotomy on temporomandibular joint TMJ)     movement, function and quality of life (QoL)   "
100786|NCT01966926|"     Scant data have been reported on the effects of weight self-monitoring during weight control.     The purpose of this pilot project was to consider the questions: Is it possible to assign     participants to engage in daily weight self-monitoring, and are there differential effects on     mood of daily versus weekly weighing?   "
100787|NCT01966913|"     High-dose chemotherapy with autologous hematopoietic stem-cell transplantation is a standard     salvage treatment used in adults with germ cell tumors (Einhorn et al, J Clin Oncol 2007).      Disease prognosis following 1 to 2 intensified combinations of etoposide - carboplatin +/-     ifosfamide depends on the patient's performance status (PS) at inclusion and the prior     sensitivity of the disease to cisplatin. A poor PS and/or being refractory to cisplatin     suggest a higher toxicity and a bad prognosis.      However, predictive factors of response to high-dose chemotherapy do not include a     chemo-sensitivity phase with a semi-intensive chemotherapy excluding a platinum compound     (epirubicin - paclitaxel), which still allows stem-cell harvest. The use of this chemotherapy     combination induced a response in more than one third of the patients treated during disease     progression in the TAXIF I study. The same strategy was tested in the TAXIF II study, which     completed the inclusion of 45 patients and was closed in May 2008. Results of the TAXIF II     study, are currently being analyzed; they support the hypothesis to prioritarily treat     patients with a sensitive relapsed disease at the time of the high-dose administration.      A combination of a semi-intensive sequential ICE type chemotherapy plus bevacizumab was used     on a highly refractory patient. A 5 months nearly complete response was achieved. Indeed, the     overexpression of VEGF (Vascular Endothelial Growth Factor) has been identified as an     independent risk factor in patients with germ cell tumor. Therefore, a treatment strategy     using an inductive chemotherapy followed, in case of response, by a double intensification     therapy in combination with a VEGF treatment, could be an interesting approach in patients     with poor prognosis germ cell tumors.      The aim of this phase I/II trial is to assess the feasibility of a Bevacizumab - ICE     (Ifosfamide-Carboplatin-Etoposide) high dose combination with the support of autologous     hematopoietic stem cell for two intensive consecutive cycles (tandem intensification) in     patients with a poor prognosis germ cell tumor non refractory to a front-line mobilization     chemotherapy using two half intensified consecutive combinations of Epirubicin-Paclitaxel.   "
100799|NCT01966757|"     Neuronal Ceroid Lipofuscinosis (NCL) also known at Batten's disease is the most common     neurodegenerative disorder in children. Families often report the patient has a sleep     disturbance. This is a questionnaire to be completed by the family to better understand the     sleep pattern and sleep difficulties experienced by individuals who have been diagnosed with     NCL.   "
101933|NCT01951898|"     Montelukast is one of anti-inflammatory agents and a good controller for the patients with     asthma. The hypothesis of the study is that the Montelukast will have airway     anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.   "
100788|NCT01966900|"     The potential HIV vaccine has two components: a protein immunogen based on the coat protein     of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The     immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous     formulation (GLA-AF).      We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response     stimulated by the vaccine) when it is given in two different dose regimens:      Group A: vaccinations at Months 0, 1, 2 and 6; and Group B: vaccinations at Months 0, 1, 2     and 12.      Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5     micrograms of GLA-AF.      We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the     vaccine by monitoring the occurrence of adverse events in the participants. We will assess     the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood     and in genital mucosal secretion samples.   "
100789|NCT01966887|"     The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer     on cardiac volumes and function using multimodality cardiac imaging.   "
100790|NCT01966874|"     The purpose of this study is to determine the efficacy and acceptability of a regimen of 200     mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.   "
100791|NCT01966861|"     The present study aims to evaluate the impact of a weaning strategy based on identification     of early signs of respiratory distress by lung ultrasound and the consequent implementation     of a clinical optimization protocol as compared to usual care.   "
100792|NCT01966848|"     In the history of TKA several different types of prosthetic designs have been evolved in     order to optimize knee function after total knee replacement. The most common difference     between the prosthetic designs revolves around issues concerning the preservation of the     cruciate ligaments. The most popular prostheses have been the posterior stabilized prosthesis     (PS) in which both cruciate ligaments are resected and the posterior cruciate retaining     prosthesis (CR) in which only ACL is resected and PCL is preserved. Both these prosthetic     designs have shown excellent clinical results in the literature.      In the knee the role of the cruciate ligaments is to insure anterior/posterior stability, but     studies have also shown, that the cruciate ligaments contain proprioceptive mechanisms which     control joint kinematics essential for accurate knee function. One could therefore imagine     that a prosthetic design that preserves both cruciate ligaments would be superior to     prosthetic designs in which ACL or ACL/PCL is resected in achieving good clinical results and     patient satisfaction.      Only a few prosthetic designs, which preserve both cruciate ligaments, have been available to     the market. However studies based on fluoroscopic assays and gait analysis has shown that     this prosthetic design is superior to cruciate sacrificing designs in preserving normal knee     kinematics during activities of daily living after TKA. Studies, in which patients have     received two different types of prosthesis in each knee, have also shown that bi-cruciate     retaining TKA's is preferred, when compared to more constrained prosthetic designs.      The new Vanguard XP TKA system (Biomet®, Warsaw, Indiana, USA) is a further development of     the Vanguard TKA system, which has shown good clinical results in earlier studies. With the     new Vanguard XP system both cruciate ligaments are preserved. In theory this should result in     a more natural feeling of the knee because the stability and proprioceptive signals from both     cruciate ligaments are preserved. In order to investigate the potential benefits of this new     prosthetic design, the clinical and radiological results of knees receiving a Vanguard XP and     Vanguard CR prostheses are compared.      In this study we wish to investigate:        1. If the use of the Vanguard XP prosthesis will influence the migration of the femur- and          tibial components measured by Radiostereometric Analysis (RSA) when compared to the          Vanguard CR prosthesis.        2. If the use of the Vanguard XP prosthesis will result in increased participant knee          function, satisfaction and quality of life when compared to the Vanguard CR prosthesis.        3. If the use of the Vanguard XP prosthesis will influence radiologic signs of osteolysis,          complication rates and revision rates when compared to the Vanguard CR prosthesis.      This project is carried out as a randomized controlled double-blinded trial, in which the     clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of     either a Vanguard XP or Vanguard CR prosthesis is compared.   "
100793|NCT01966835|"     Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis     and are associated with an increased risk of co-morbidity and all-cause mortality.Few studies     have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and     the focus has primarily been on medical treatment. Aerobic exercise training constitutes a     potentially promising, non-pharmacological alternative to improve sleep.      This study is a randomized controlled trial of 44 patients with rheumatoid arthritis.      The aim is to investigate the effect of a moderate-to-high intensity aerobic interval     training intervention on sleep quality and sleep disturbances in patients with rheumatoid     arthritis.      The primary hypothesis is that moderate-to high intensity aerobic exercise will improve     objective measured sleep quality and sleep disturbances. The secondary hypothesis is that the     intervention may improve fitness, subjective sleep quality and physical function as well as     reduce pain, fatigue, depressive symptoms and improve health-related quality of life.   "
100794|NCT01966822|"     Protease inhibitors (PI) have been associated with an acceleration of bone mineral density     loss in HIV-infected individuals because of an enhanced osteoclast activity, although some     controversial data have been also published. A first study suggest an increase of bone     mineral density after switching from PI to raltegravir, the first generation integrase     inhibitor, but there are no more data about this subject.      Based on data that PI decrease bone mineral density by accelerating osteoclast cells and that     the discontinuation of this drugs could improve bone mineralization, we propose a randomized     prospective multicenter study to assess the impact of switching from PI to dolutegravir on     bone mineral density in patients with low bone mineral density receiving a PI-containing     regimen. At the same time, the study will help to assess the antiviral efficacy and safety of     a PI-sparing regimen including dolutegravir as a simplification strategy in virologically     suppressed patients.   "
100795|NCT01966809|"     This study will be aimed at investigating the effectiveness of a treatment for brain tumors     called Photodynamic Therapy, or PDT. Briefly, a subject will receive a light-sensitive drug,     called Photofrin®, the day before a tumor removal surgery. The next day, after the tumor is     removed, red light from a laser will be shone into the tumor cavity through a light-diffusing     sphere. This light will activate the photosensitizer, and possibly kill any tumor cells that     may be left.      We plan to measure how long the subject may go without a new tumor regrowth, and overall how     long subjects survive. We will compare these results to typical results to see if we are     seeing any improvements.      Objective: To define the antitumor activity of Photofrin® and laser light activation within     the confines of a Phase II study.   "
100796|NCT01966796|"     Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the     management of health-care associated pneumonia (HCAP). Multiple risk factors have been     proposed, some of which overlap with items of the pneumonia severity index (PSI). The aim of     this study was to investigate the relationship between PSI and presence of MDR pathogens.      Methods Patients who were admitted to a tertiary-care hospital from January 2005 to December     2010 were screened by a discharge diagnosis of pneumonia. Patients were enrolled if they     fulfilled the definition of HCAP by 2005 ATS/IDSA guideline.   "
100797|NCT01966783|"     The purpose of this study is to investigate the efficacy and safety of budesonide suppository     for the treatment of acute ulcerative proctitis.   "
100798|NCT01966770|"     The aim of this fitting study is to evaluate the clinical performance of different hydrogel     and silicone hydrogel contact lenses.   "
100800|NCT01966744|"     The purpose of the study is to develop, evaluate, and optimize an interactive website (the     SMART portal). The SMART portal will use IBD-specific and general assessments and     interventions to reduce the burden of common barriers to treatment adherence and enhance     self-management skills. This study aims to build and revise the SMART portal according to     feedback and testing from participants.   "
100801|NCT01966731|"     REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for     children with confirmed SCA between 12 months and 10 years of age. The short-term goal is to     obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for     children with SCA in multiple distinct research settings in Africa. Based on that     information, the longer-term goal is to make hydroxyurea more widely available for children     with SCA in Africa, particularly those identified with SCA through expanded newborn screening     programs.   "
100802|NCT01966718|"     It is hypothesized that repository corticotropin injection in combination with other biologic     agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of     rheumatoid arthritis for patients with disease that had inadequately responded to biologics     previously.   "
100803|NCT01966705|"     Background      Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the     Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with     considerable personal distress, functional disability and societal costs. Several studies     have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety,     both on anxiety itself and on secondary symptom measures (for example of depression). One     published randomized controlled trial (RCT) has examined the feasibility of delivering CBT     for severe health anxiety via the Internet as a form of guided self help. Participants had     contact with a therapist via an e-mail-like system throughout the treatment. This approach     yielded results superior to a waiting-list condition, thus potentially greatly increasing the     availability of psychological treatment. However, more studies on the effects of     Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known     about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For     example, the significance of therapist support in relation to treatment outcomes remains to     be determined. CBT-based self-help literature, so called bibliotherapy, has shown great     promise in the treatment of several anxiety disorders, including panic disorder and social     anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or     minimal therapist contact could be suitable for treating health anxiety.      Aim of the study      The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33),     Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without     therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants     with severe health anxiety.      Participants in all treatment programs are expected to be significantly improved on measures     of health anxiety, compared to participants allocated to the waiting-list condition.   "
100804|NCT01966692|"     When a drug company first develops a drug, the company has to show the Food and Drug     Administration (FDA) that the drug is safe and effective. If FDA concludes that the drug is     safe and effective, FDA approves the drug. The company can then sell the drug, which the     company does using trade name. Only the drug company that developed the trade name drug     is allowed to sell it. However, other drug companies can create their own version of the     trade name drug, which usually happens after the patents for the trade name product run     out. These drugs, often called generic drugs, potentially will be less expensive for the     patient. In order to sell generic drugs, drug companies must show that their generic version     is the same as the trade name drug in a number of ways. For example, they generally have to     show that their product is intended to be used to treat the same diseases or conditions, that     it has the same label, and that the product has the same active ingredient as the trade     name drug. The generic company also has to show that generic product is bioequivalent to     the trade name drug, meaning that the generic product gets to the part of the body where the     drug works at the same rate that the trade name drug does. How to show how much drug gets to     the part of the body where it works, and how fast, depends on the type of product the drug     is. The primary aim of this research study is to aid the FDA in finding methods to ensure     that the versions of generic drugs that are inhaled (for example, drugs used to treat asthma)     are bioequivalent to the trade name drug. As a part of the research study, pharmacokinetic     (PK) studies (studies measuring drug levels in the blood over time after inhalation) will be     done using three different versions of fluticasone propionate (FP, a drug routinely used in     asthmatic patients) administered using a dry powder inhaler (DPI, an inhalation device that     delivers the drug as a dry powder). The results from this study will help FDA ensure that     generic products are the same as the trade name drugs.   "
100805|NCT01966679|"     This study is a NIMH-funded multi-site clinical trial that includes UCLA as the coordinating     site, with Emory University and Seattle Children's Hospital, as other recruiting sites, and     the Nathan Kline Institute as the Data Management Center. The purpose of the study is to     examine the effects of an investigational drug, AZD7325, as a potential treatment for     high-functioning adults 18 -35 years old with Autism Spectrum Disorders (ASD). The primary     study measures are effects on brain waves as measured by non-invasive brain wave recordings     (electroencephalograms or EEGs), assessments of side effects, and measures of attention and     learning.      The study drug, AZD7325, is manufactured by Astra Zeneca, and was initially tested as a     medication for anxiety disorders in over 488 subjects, but was not pursued for marketing due     to too few benefits for anxiety. AZD7325 was found to have a very good safety profile and was     tolerated by the majority of subjects. AZD7325 has some similar actions to currently marketed     anxiety drugs in the benzodiazepine class, but lacks the sedative and negative effects on     attention of the benzodiazepines. The study drug is designed to target the GABA     neurotransmitter system which is believed to be abnormal in this population.      There are 2 study phases. Phase 1 includes the recruitment of 24 healthy volunteers without     mental disorder (6 per site) in order to establish normal EEG reference ranges. Controls will     only be seen for one study visit which includes a clinical evaluation, physical exam, routine     blood tests, and an EEG. Once control recruitment is complete, Phase 2 will begin.      Phase 2 involves the recruitment of 40 adults (10 per site) 18 - 35 years old with a     diagnosis of ASD, normal intelligence, and specific EEG patterns compared to control values.     Screening for eligibility will be performed in one visit, which includes a clinical     evaluation, tests of learning and intelligence, blood and urine tests, and an EEG. Those     subjects who are found to be eligible will be enrolled in a 6-week medication study. Subjects     with ASD who are enrolled will be randomly assigned to receive the study drug AZD7325 or     placebo in matching capsules. Subjects will be seen weekly by study physicians and clincians     for the 7 study visits, including 3 additional EEG recordings, and then for a final follow-up     visit (9 total visits including screening lasting up to 11 weeks to complete). Study     physicians can adjust the dose of study medication to reduce any side effects.   "
100806|NCT01966666|"     The purpose of the study is to determine the highest dose of TPI-287 that is safe and     tolerable when administered as an intravenous infusion to participants with mild to moderate     Alzheimer's disease (AD), to measure pharmacokinetic properties of the drug as well as to     gauge preliminary efficacy of TPI-287 on disease progression.   "
100807|NCT01966653|"     Developed before the establishment of a structured process for drug assessment,     nitrofurantoin is now being prescribed frequently given the rise in multi-resistant     gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical     effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness     and better define the side effect profiles of both nitrofurantoin and fosfomycin. This     multi-center open trial will randomize 600 non-pregnant women at three international sites     (200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant     uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive     either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral     fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and     28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior     to fosfomycin in clinical efficacy at final follow-up.   "
101051|NCT01963442|"     To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when     compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of     treatment in terms of clinical efficacy, in adults admitted to emergency services for a non     severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin     treatment (3GC or A/AC).   "
100808|NCT01966640|"     Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy,     peanuts and egg allergy are one of the most common.      Actually when there is a suspicion of food allergy, the OPT is the gold standard for the     diagnosis. During the OPT we give increasing doses of the allergen to the patient and     evaluate threshold causing a clinical reaction. This test is associated with a risk of strong     allergic reaction and need a medical supervision.      Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of     these allergy. Some publications demonstrate that these tests lack sensibility and     specificity for child food allergy diagnosis.      New tests have to be develop to diagnosis child food allergy without risks. The BAT is a     cellular test able to evaluate the basophiles activation by specific allergen in vitro. This     test allow us to evaluate more physiologically the sensitization of patients to an allergen.     It is already used in drug allergy and it has been evaluated in infant milk allergy in an     other clinical trial.      In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food     allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with     food allergy and compare this results with the OPT at the same time. If the BAT results can     predict the sensitivity of children to food allergen, it could limit the use of the OPT and     reduce the risk of this test.   "
100809|NCT01966627|"     This is a study to investigate genetic predisposition to hepatic steatosis and the expression     of gluconeogenic and lipogenic genes in livers of obese children and adolescents.      Hypothesis 1: Common variants recently associated with variation in plasma TG levels     identified in Genome Wide Association Studies (GWAS) (such as GCKR, PNPLA3) can affect     accumulation of fat and subsequent development of Non Alcoholic Fatty Liver Disease (NAFLD).     Gene variants act in additive or synergistic manner with progressive liver fat accumulation     per additional risk allele.      Hypothesis 2: With increase in hepatic fat content NASH and fibrosis will increase.     Furthermore, expression of lipogenic markers (SREBP1c) will increase.   "
100810|NCT01966614|"     The purpose of this study is to evaluate the safety and efficacy of a single treatment of     PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.   "
100811|NCT01966601|"     To evaluate the overall safety and efficacy of TRV027 when administered in addition to     standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients     hospitalized with Acute Decompensated Heart Failure (ADHF).   "
100812|NCT01966588|"     The purpose of this study is to find genes that predict whether or not a person will develop     side effects to antipsychotic medications, such as weight gain, blood sugar dysregulation, or     immune cell abnormalities. We will be collecting blood samples from participants who are     taking second-generation antipsychotic medications. These blood samples will be stored over     the long-term in a biobank, and will be used for later genetic testing and other cell-based     studies.   "
100813|NCT01966575|"     Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not     produce an egg each month, resulting in irregular periods. As a result, these women often     need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional     'clomiphene protocol' begins with a short course of progestin treatment to bring on a period     (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence,     however, has suggested that this progestin-induced shedding of the uterine lining (i.e.,     withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to     determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS     undergoing a clomiphene cycle.      It is hypothesized that patients who undergo ovulation induction with clomiphene citrate     without prior endometrial shedding will have higher clinical pregnancy rates than those who     begin with a progestin-induced withdrawal bleed.   "
100814|NCT01966562|"     The PAHA study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT     is to compare the effectiveness of the WHOLE-BODY VIBRATION (WBV) with the Multi-component     training control group and control group (CG) for psychological well being, quality of life,     proactive attitude and happiness in female aged subjects.   "
100815|NCT01966549|"     The purpose of the study is to evaluate the effect of CNTO6785 compared with placebo in     participants with moderate to severe Chronic Obstructive Pulmonary Disease.   "
100816|NCT01966536|"     Women delay maternity and, as a consequence, available oocyte number and their quality     decrease (9-18% of all IVF patients). Different treatment protocols have been developped     nevertheless none of them optimal: the number of oocytes retrieved depends on the present     ones. New generation of oocytes and follicles has been defended by some authors and bone     marrow seems to be involved. What seems crucial is the niche that produces paracrine signals     able to activate dormant cells and to attract undifferentiated cells from other tissues     (homing). This phenomenon has been described by our group in other human reproductive tissues     like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women     with poor ovarian reserve by means of bone marrow protective capacity.      CD133+ cells obtained from bone marrow will be delivered into the ovarian artery allowing     them to colonize ovarian niche.      The study hypothesis is that CD133+ cells will improve ovarian reserve differentiating     themselves into germ cells or, more likely, stimulating the niche to activate dormant     follicles.   "
100817|NCT01966523|"     To conduct a pilot study of cluster randomized clinical trial of an practice intervention to     improve the quality of care for suspected lower respiratory and and urinary tract infections     among 60 nursing home residents with advanced dementia living in 4 facilities (2 matched     intervention/control pairs) for 12 months. We hypothesize that 1. In the intervention     compared to the control facilities there will be a trend towards a greater proportion of     infections for which antimicrobials were initiated appropriately, and 2. in the intervention     compared to the control facilities there will be a trend towards higher proxy satisfaction     with decision-making, fewer hospital transfers, and lower antimicrobial exposure.   "
100960|NCT01964638|"     This is a prospective single center trial to examine the rates of cancer diagnosis when using     computerized software to target suspicious lesions within the prostate identified on mpMRI.     The primary evaluation involves comparing the rate of cancer diagnosis when using     software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use     of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis     being tested is that fusion guided biopsy will increase detection prostate cancer within     mpMRI findings as compared to visual guided biopsy of these areas   "
100818|NCT01966510|"     Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical     or mismatch donor.      Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion     criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade     non-hodgkin lymphoma in third line (who already received at least one autologous     transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one     autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in     relapse less than 2 year after a fludarabine nbased regimen or in relapse after one     autologous transplantation.      Stem cell source: Two cord blood units containing both together more than 3x107 frozen     nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the     patients.   "
100819|NCT01966497|"     The main objective of this observational survey is to estimate the incidence, the typology,     and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old.     In this age group (aged more than 60y), three groups of patients with very different response     rates and late outcome can be delineated with specific standard chemotherapy.   "
100820|NCT01966484|"     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as     rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with     neostigmine. The investigators compare the intubating conditions, incidence of postoperative     myalgia (POM), patient satisfaction and the postoperative performance with respiration     exercise device for these two muscle relaxants.   "
100821|NCT01966471|"     This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety     of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination     with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth     (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and     anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a     dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg)     intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at     a dose of 420 mg IV q3w in combination with a taxane.   "
100822|NCT01966458|"     This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the     stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood     pressure management. The study compares results of stroke incidence in a new cohort of     subjects receiving optimal blood pressure management to a reference stroke incidence observed     in the original IDE clinical trial (HW004) that did not specify optimal blood pressure     management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free     success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for     destination therapy). Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1     ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary     and secondary endpoints at 12 months, with a subsequent follow-up period extending to 5 years     post implant.   "
100823|NCT01966445|"     Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of     solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression     and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a     monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3.     This study is a phase I, first time in human, open-label, dose escalation study. The purpose     of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD)     of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be     conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD     cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In     Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected     based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended     dose regimen and also to evaluate preliminary evidence of clinical benefit.   "
100824|NCT01966432|"     This add-on study of providing tobacco, alcohol and other drug screening, brief intervention     and referral for treatment to a primary care high risk diabetic population leverages the     existing research resources of a funded parent project Duke University CMS Innovation Award     Southeastern Diabetes initiative (PI: Robert M. Califf, MD) to explore the feasibility of     implementing Screening for substance use, Brief Intervention, and Referral to Treatment     services in Primary Care (SBIRT-PC) and to examine the effects of substance use status on     diabetes health care outcomes. This pilot study also examines the feasibility of the CTN's     common data element algorithms of SBIRT for illicit and nonmedical drug use in the primary     care setting.   "
100825|NCT01966419|"     The purpose of this study is to determine whether ornithine phenylacetate can speed recovery     from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.   "
100826|NCT01966406|"     Nasogastric decompression was routinely used in most major intra-abdominal operations.     Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting,     and gastric distension). Wound and respiratory complications, and to reduce the incidence of     anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric     decompression following elective abdominal surgery has been increasingly questioned over the     last several years. Many clinical studies have suggested that this practice does not provide     any benefit but could increase patient discomfort and respiratory complications. Furthermore,     meta-analyses have concluded that routine nasogastric decompression is no longer warranted     after elective abdominal surgery.      Elective abdominal surgery without nasogastric decompression was initially tested and then     widely used on patients with colorectal surgery. However, after upper gastrointestinal     operations such as gastrectomy, nasogastric has been considered necessary to prevent the     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of     colectomy .      In spite more and more studies reported of no need of nasogastric tube after abdominal     operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in     studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include     anticipated prolonged postoperative paralytic ileus caused by PD-related extensive     destruction and potential risk of gastric stasis after PD. However, our pilot study of     retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD     at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount     in the first three days after operation. Theoretically, these patients will not need a     nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective     multicenter randomized trial to assess the need of a nasogastric tube after PD.      Elective abdominal surgery without nasogastric decompression was initially tested and then     widely used on patients with colorectal surgery.7-10 However, after upper gastrointestinal     operations such as gastrectomy, nasogastric has been considered necessary to prevent the     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of     colectomy .11-13 In spite more and more studies reported of no need of nasogastric tube after     abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of     lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy     include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive     destruction and potential risk of gastric stasis after PD. However, our pilot study of     retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD     at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount     in the first three days after operation. Theoretically, these patients will not need a     nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective     multicenter randomized trial to assess the need of a nasogastric tube after PD.   "
100974|NCT01964456|"     The purpose of this study is to demonstrate that bodily self-consciousness is subjectively     and inter-subjectively constituted and that some dimensions of the bodily self-consciousness     are impaired in Anorexia nervosa.   "
101052|NCT01963429|"     This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency     ablation and hypofractionated proton beam radiation.   "
100827|NCT01966393|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would     regulate glucose levels through the infusion of two hormones: insulin and glucagon.      The main objective of this project is to compare the efficacy of single-hormone closed-loop     strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate     glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.      The investigators hypothesized that 1) Controlling glucose levels using single- or     dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2)     Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in     hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional     pump therapy.   "
100828|NCT01966380|"     The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing     performance properties is fulfilled and that the dressing is safe when used on wound types     such as pressure ulcer, leg ulcer, and diabetic foot ulcer.   "
100829|NCT01966367|"     This study's goal is to determine the frequency and severity of acute graft versus host     disease, to evaluate incidence of primary and secondary graft rejection, to assess event free     survival and overall survival, to determine the time to neutrophil and platelet engraftment,     to determine the time to immune reconstitution (including normalization of T, B and natural     killer (NK) cell repertoire and Immunoglobulin G production), and to establish the incidence     of infectious complications including bacterial, viral, fungal and atypical mycobacterial and     other infections following CD34+ selection in children, adolescents and young adults     receiving an allogeneic peripheral blood stem cell transplant from a family member or     unrelated adult donor for a non-malignant disease.   "
100830|NCT01966354|"     The purpose of this study is to assess the efficacy and safety of three ultrasound assistance     techniques for internal jugular venous cannulation, in terms of cannulation success and     prevention of complications.   "
100831|NCT01966341|"     This program has been created to help patients with irritable bowel syndrome manage their     symptoms and increase their functioning by using cognitive therapy skills and hypnosis.   "
100832|NCT01966328|"     This research is studying the effect that Resolvine injection will have on patients with     vitreomacular adhesion.   "
100833|NCT01966315|"     The investigators are going to compare the sleep quality and quantity between dexmedetomidine     group and midazolam group using 24 hour polysomnography in critically ill patients. And the     investigators also compare the incidence of delirium between the two groups.   "
100834|NCT01966302|"     The purpose of this study is to see if Lung LLC's new experimental formulation of the     medicine Beraprost Sodium, called Beraprost Sodium 314d Modified Release (BPS-314d-MR), can     improve the symptoms of pulmonary arterial hypertension (PAH) in patients. An experimental     drug is one that has not been approved by the U.S. Food and Drug Administration for use in     the general public. This research study is for patients who have pulmonary arterial     hypertension (PAH) and have just completed taking part in an earlier research study and     received an older experimental formulation of Beraprost Sodium, called Beraprost Sodium     Modified Release (BPS-MR). That earlier study was being done to see if BPS-MR could improve     their PAH.      Patients may also be taking Tyvaso (treprostinil), Tracleer (bosentan), Letairis     (ambrisentan), Adcirca (tadalafil) and/or Viagra or Revatio (sildenafil) to treat their PAH.     The diagnosis of PAH means that the blood pressure in their lungs is higher than normal. The     increased blood pressure in the lungs places a strain on the heart. The strain causes the     heart to pump less blood into the lungs, causing shortness of breath and tiredness. The     strain on the heart weakens the heart muscle making it less able to pump blood, a condition     called heart failure. As heart failure develops, swelling in the feet and abdomen may occur.   "
100835|NCT01966289|"     This study will be looking at whether CY/GVAX in combination with SGI-110 is effective     (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe     in patients with metastatic colon or rectum cancers.   "
100836|NCT01966276|"     The Synergy Trial will evaluate the safety and efficacy of a currently available medication     (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS Nutrient     Formula) to treat Chronic Fatigue Syndrome (CFS).   "
100837|NCT01966263|"     The objective of this study is to determine whether either a femoral nerve block (FNB) or     local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal     functional outcome after one year in patients receiving a total knee arthroplasty and     following a fast track rehabilitation protocol.   "
100838|NCT01966250|"     The purpose of this study is to find out the effectiveness of integrative medicine model for     pain relief and improvement of function and quality of life on the patients with pain after     back surgery.   "
100839|NCT01966237|"     Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine     (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines     excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary     biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through     urinary biomarkers can predict altered drug levels is unknown.      Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting     in low blood pressure. Dose adjustments are not currently possible because of the late rise     in SCr, and are based on clinical parameters that may lead to clinically relevant over or     under-dosing. Thus, this study will address an important knowledge gap being the first to use     elevations of AKI biomarker concentrations to anticipate increased milrinone levels.   "
100851|NCT01966068|"     This study will enroll parents/guardians of children who receive treatment at one of the     pediatric primary care practice settings in the Pediatric Research in Office Settings (PROS)     network or at the Children's Hospital of Philadelphia's Pediatric Research Consortium (PeRC)     network.      The study will use an evidence-based conceptual model to study determinants of implementation     success, implementation outcomes, and health care outcomes resulting from implementing an     already functional, electronic health record (EHR)-linked asthma portal, MyAsthma. The study     will measure the portal's feasibility and determine the impact on providing asthma education     and fostering patient engagement as well as the ability to collect patient-reported outcomes     for children, evaluate medication use and side effects and track parents' preferences and     goals.   "
100840|NCT01966224|"     This is a continuing research study of a vaccine for allergy to Japanese Red Cedar. The     vaccine is called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the     vaccine is tolerated and how previous Phase IA research participants respond to the vaccine     in a booster dose. CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not     approved for use by the United States Food and Drug Administration (FDA) but is available in     research studies like this one. The study is a Phase IB, prospective, three cohort, open     label study conducted on one cohorts of non-atopic subjects and two cohorts of subjects with     a history of allergic rhinitis symptoms to Japanese red cedar CryJ 2 pollen allergen that     participated in the previous Phase IA study (all the subjects participated in the previous     study). The study will be conducted at 1 study center. Subjects are enrolled in the trial for     a period of 80 days. The objectives of the statistical analyses are to establish the safety     and to explore the immunogenicity of the LAMP-vax vaccine. All statistical analyses conducted     on the data from this trial will be exploratory in nature.      The primary objective of this Phase IB Study is to evaluate the safety and immunological     responses of an additional dose of CryJ2-DNA-LAMP plasmid vaccine delivered intramuscularly     (IM) to subjects who previously received 4 doses of CryJ2-DNA-LAMP vaccine delivered IM every     2 weeks in the previous Phase IA study.   "
100841|NCT01966198|"     Novel pulse plethysmography-derived indexes has been proposed as a tool to measure autonomic     nervous system modulation in anaesthetized and awake patients, but nowadays a physiologic     validation is lacking. We aim to examine the effects of sympathetic stimulation on pulse     plethysmographic amplitude (PPGA), autonomic nervous system state (ANSS) and autonomic     nervous system state index (ANSSi).   "
100842|NCT01966185|"     The purpose of this study is to establish learning curves of mastoidectomy training in     virtual surgical simulation training, to establish the long-term effect of repeat simulation     training and to explore the transfer of skills, the roles of an integrated tutor function,     self-directed learning and cognitive load.   "
100843|NCT01966172|"     To test if multimodal analgesia with different analgesic medication offer better pain relief,     lesser side effects and is safe compared to conventionel opiod analgesia after cardiac     surgery.   "
100844|NCT01966159|"     The purpose of this study is to assess the safety and effectiveness of the SYNERGY™ Coronary     Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length     (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual     estimate)   "
100845|NCT01966146|"     Aim of the study is the definition of criteria for a standardized assessment of heart     function by 3D echocardiographic procedures. Standardized criteria will be defined to assess     aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.   "
100846|NCT01966133|"     Investigators hypothesise that the use of transarterial chemoembolisation (TACE) after liver     resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in     the liver and thus improve survival of patients with high risk factors for residual tumor.     The aim of this study is to compare the survival of patients with high risk factors for     residual tumor undergoing liver resection plus post-operative TACE versus liver resection     alone.   "
100847|NCT01966120|"     The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz)     versus placebo in the field-directed treatment of mild to moderate actinic keratosis with     photodynamic therapy (PDT) when using the BF-RhodoLED lamp.   "
100848|NCT01966107|"     The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse     cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to     assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study     is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the     effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients     with moderate to very severe COPD, as defined by the Global Initiative for Chronic     Obstructive Lung Disease (GOLD) criteria.   "
100849|NCT01966094|"     It is estimated that over 1 million people in the United States have HIV infection. While HIV     is treatable, there are still high rates of HIV-associated neurocognitive disorder (HAND).     HAND is defined by low scores on memory testing. To meet the criteria for HAND, an     HIV-infected individual has to have a low score on at least two different memory tests. It is     estimated that 20-50% of people living with HIV have HAND. It is therefore still a common     problem. While individuals with HAND typically improve on antiretroviral therapy for HIV,     often this improvement is incomplete. Also, there are over 20 antiretroviral medications     approved for HIV in the US. It is not clear if the specific choice of antiretroviral     medication makes a difference in the improvement of HAND.      The investigators have designed a small preliminary study in which subjects with and without     HAND who have never been on treatment for HIV or have been off treatment for at least 6     months are followed for the first 12 months after starting antiretroviral therapy.The     investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will     also be followed by their primary HIV medical provider. For the study, subjects will be     followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks.     Memory testing will be performed at baseline and each followup visit. Blood will also be     taken at baseline and the three followup visits to measure changes in inflammation. A lumbar     puncture will be performed at baseline and at 24 weeks to measure changes in inflammation and     amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at the     last study visit of 48 weeks   "
100850|NCT01966081|"     The aim of the study is to establish the existence of a relationship between the dietary     intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans,     using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the     abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte     phospholipids.   "
100852|NCT01966055|"     A study of the safety and pharmacokinetics of solithromycin capsules in adolescents   "
100975|NCT01964443|"     The purpose of this study is to explore the impact of plaque psoriasis on the different     dimensions of patient life including psychological disorders, different types of addictions,     and their consequences on health-related quality of life and socioeconomic parameters at     baseline (cross-sectional part) and during the initial years of the psoriasis disease     (longitudinal part).   "
100853|NCT01966042|"     Therapeutic neovascularization is an innovative strategy for cardiac tissue recovery due to     chronic, intense ischemia. Thus stem cell therapy has become a promising procedure for the     large number of patients with refractory angina due to coronary disease, despite of the use     of multiple anti-angina medications, remain severely symptomatic with disabling angina.      Stem cell therapy using autologous cells from the patient's bone marrow, has been shown to be     safe and associated with improved myocardial perfusion, reducing the symptoms of advanced     coronary artery disease and increasing the functional capacity of patients whose therapeutic     armamentarium available today has been exhausted.      The study hypothesis was that the infusion of autologous mononuclear cells derived from the     patient's bone marrow and delivered via intramyocardial injection in patients with refractory     angina and normal or slightly depressed ventricular function, promote improvement in the     anginal symptoms and myocardial perfusion by the inducing neoangiogenesis.   "
100854|NCT01966029|"     There is currently no treatment for MPS IVA other than supportive care for the clinical     manifestations of the disease. Enzyme replacement therapy (ERT) with BMN 110 to replace the     deficient GALNS is a potential new treatment option for MPS IVA patients. BMN 110, containing     recombinant human GALNS (rhGALNS) developed by BioMarin is expected to reduce the     progressive, pathologic accumulation of KS, and improve signs and symptoms of the disease.      The objective of this Phase 3B open label study (110-502) will be to evaluate the safety and     tolerability of 2.0 mg/kg/week (qw) of BMN 110 in Australian patients with MPS IVA. In     addition, a number of secondary and tertiary efficacy endpoints will also be investigated.     The dose and regimen of BMN 110 have been selected on the basis of data from a Phase 1/2     clinical study with BMN 110, nonclinical and in vitro studies with BMN 110, and clinical and     nonclinical data from other enzyme replacement therapies.      Extension Phase is included per amendment dated 10Mar 2014: To provide patients enrolled in     the Initial Phase access to BMN 110 until commercial product becomes available in Australia     and continue to assess long-term safety   "
100855|NCT01966016|"     Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left     ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive     heart failure and wide QRS in ECG. Positive response presents as improvement in quality of     life, decrease in congestive hrat failure symptoms and signs, improvements in     echocardiographic measurements and longer survival. About 30% of the patients do not respond     to this treatment.      A decrease in clinical response to CRT is expected in patients with those predictors:     advanced age, male, ischemic etiology of cardiomyopathy, Non-LBBB pattern in ECG, lack of     mechanical dyssynchrony, large scar in LV, congestive heart failure stage IV, and non-cardiac     co-morbidities (lung disease, pulmonary hypertension, renal failure and diabetes).      There are few solutions to increase the rate of clinical response to CRT, for example:     endocardial pacing of LV or pacing a few simultaneous sites on LV. A study that investigated     a method of simultaneous pacing on LV of patients with congestive heart failure and LBBB with     QRS>150ms has shown major improvement of cardiac contraction (increased dP/dtmax) compared to     a single pacing site over a postero-basal or lateral wall site).      Implantation of pacemaker leads- one in right ventricle (RV) and two over LV, i.e. multisite     cardiac resynchronization therapy (MSCRT), has a few potential advantages, compared to     conventional CRT.   "
100856|NCT01966003|"     The purpose of this research study is to compare the effectiveness and safety of ABP 215     against bevacizumab in men and women with advanced non-small cell lung cancer.   "
100857|NCT01965990|"     Body weight excess, from overweight to overt obesity, is associated with adverse health     outcomes. In view of the time-trends of the obesity epidemic and the related cost burden, the     search for effective strategies for weight reduction and long-term maintenance of weight loss     (WL) is at the top of the agenda of public health systems.      The current first-line strategy includes several treatment options and dietary interventions     to be implemented together with an exercise program. Unfortunately, compliance with     intervention in the long-term is difficult. It is not infrequent to observe people following     one diet after another and experiencing multiple failures which, in turn, lead to higher body     weight and adverse consequences on body composition and fat distribution. The higher the     number of attempts, the more difficult the adherence to further interventions. In the     presence of severe (body mass index >40 kg/m2) or complicated obesity, bariatric surgery     could be proposed. This therapeutic option is effective, but is not devoid of complications     and may be irreversible. Obesity-related complications, such as diabetes, hypertension or     sleep apnoea are likely to occur more frequently with increasing body mass index (BMI) and     rapid and considerable WL is mandatory to curtail such risks.      In this scenario, alternative treatment options are warranted. About 40 years ago, after the     introduction of protein-sparing modified fasting (PSMF) achieved through the use of oral     high-protein foods or liquid formula diets by Blackburn and Bistrian, several studies     evaluated its effectiveness and safety. They showed that responsible and supervised very-low     calorie diets (VLCDs) could be considered safe and appropriate therapy for obesity.      The purpose of the present study was to investigate the potential role of a 2-week course of     enteral treatment with a very low-calorie protein-based formula in the management of severe     obesity.      The rationale of this treatment option rests on the following considerations: 1) VLCDs appear     to be able to reduce cardiovascular risk rapidly and effectively; 2) VLCDs induce     considerable short and long-term WL; 3) optimal compliance with the intervention, as active     participation of the patient is not required; 4) continuous administration of the     intervention formula by enteral route enables the the maintenance of the body amino acid     pool.      Before being proposed for clinical use, a new WL program should be scientifically evaluated.     Accordingly, in the present study, attention was focused not only on efficacy in terms of     improving the cardiometabolic risk profile, but also on the feasibility and safety of the     procedure.   "
100858|NCT01965977|"     This study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance     therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective     is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival     (OS), 3 years event free survival (EFS),Toxicities profiles, Quality of Life (FACT&GOG-Ntx)   "
100859|NCT01965964|"     Translation of a validated questionnaire (SSQ) from english to german and validation of the     german version. The SSQ consists of 17 well-structured questions for the assessment and     quantification of patient reported difficulties in swallowing function. The tool is     specifically designed to evaluate important aspects of swallowing function The questions     cover the symptoms related to combinations of variables like the anatomic region, type of     dysfunction, and the consistency of swallowed bolus.   "
100908|NCT01965327|"     Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults     for which there is presently no therapy. Recently, a study reported that interferon gamma     (IFN-g) could raise frataxin protein levels in both cell lines derived from patients with     Friedreich ataxia and in a mouse model with Friedreich ataxia. The present study will test     whether IFN-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of     children with FRDA.   "
104874|NCT01913405|"     The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe     hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing     elective surgical or other invasive procedures.   "
100860|NCT01965951|"     Problems with attention are a common and debilitating consequence of brain injury. Studies     show that poor attention is the number one predictor of poor cognitive functioning one year     post-injury. This is due to the fact that attention is a necessary component of more complex     cognitive functions such as learning & memory, multi-tasking and problem solving. In many     cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect     syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the     brain is plastic and remodeled throughout life by learning and experience, enabling the     strengthening of cognitive skills or abilities. Research has shown that brief, daily     computerized cognitive training that is sufficiently challenging, goal-directed and adaptive     enables intact brain structures to restore balance in attention and compensate for     disruptions in cognitive functioning. The study aims to understand how our computer program     can affect cognition and attention in those with acquired brain injury.   "
100861|NCT01965938|"     We will conduct a randomized trial comparing the success rate and time to intubation using     the RIFL vs. the fiberoptic bronchoscope, as the latter is commonly held to be the gold     standard of difficult airway devices. Specifically, we wish to compare the of intubation     between the two devices in patients with potentially difficult airways as defined by an     oropharyngeal class 3-4, BMI greater than 35, or in patients with a history of difficult     intubation using direct laryngoscopy.   "
100862|NCT01965925|"     This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar     disorder patients. Results will provide information on a promising treatment for     simultaneously treating both sleep and cognitive problems in stable bipolar patients. These     disabling symptoms persist despite stable mood and are strongly associated with functional     disability, making them important treatment targets that have not yet been adequately     addressed.   "
100863|NCT01965912|"     The study is a single-cohort, interventional, open-label trial to evaluate long-term     neurocognitive (NC) outcomes in children aged 4 to 5 years with phenylketonuria (PKU) treated     with Kuvan® and Phenylalanine-restricted diet over a period of 7 years.   "
100864|NCT01965899|"     The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal     LINQ insertable cardiac monitor and accompanying system in patients indicated for an     insertable cardiac monitor   "
100865|NCT01965886|"     The most common surgical approach to perform a total knee replacement is called medial     parapatellar approach. It's effective and can be applied virtually to all types of knee     deformities. The Keblish approach is an alternative approach which uses the lateral side of     the patella to enter the joint. Some orthopaedic surgeons consider the latter approach a     better option when facing a valgus deformity of the osteoarthritic knee but there is no     convincing evidence on the literature supporting one or another approach. The objective of     this study is to compare the medial vs lateral approach for total knee replacement on valgus     knee.   "
100866|NCT01965873|"     The purpose of this prospective randomised clinical trial is to compare beneficial and     harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid     replacement principle of treatment in patients with moderate to severe acute pancreatitis     (AP).      The hypothesis:        -  enteral nutrition is no significantly better compared with the nil-by-mouth principle          regarding mortality, incidence of local and systemic complications, length of hospital          stay, and intensity of the inflammatory response in patients with moderate to severe AP        -  enteral nutrition has the same safety as nil-by-mouth principle in patients with          moderate to severe AP   "
100867|NCT01965860|"     The main goal is to design a comprehensive endovascular simulation curriculum consisting of     cognitive and psychomotor skills training for endovascular management of symptomatic vascular     disease in the lower limbs (Rutherford classification 2-5; stenosis or occlusion in the     iliac, superficial femoral and popliteal arteries). The curriculum will consist of     E-learning, video-based learning and simulation exercises on the Virtual Reality simulator on     which an endovascular procedure will be simulated.      Skills transferability to real life practice will be verified by means of a RCT. In this RCT     the investigators will compare the cognitive knowledge and technical performance of     curricular trained surgical trainees with conventionally trained trainees during treatment of     patients under supervision. The hypothesis states that surgeons trained within the PROSPECT     curriculum will show improved technical knowledge of endovascular treatment of     atherosclerotic disease in the iliac, superficial femoral and popliteal arteries and will     demonstrate increased technical proficiency in the angiosuite in comparison with surgeons who     received only conventional training. Subjects will be surgical trainees (N=60). They will be     randomized into a control group (N=30) and a PROSPECT group (N=30). Both groups will continue     their traditional clinical education and the PROSPECT group will additionally be trained     within this endovascular curriculum. The investigators hope that this study may ultimately     lead to an improvement in the quality of patient care by standardizing competencies of     endovascular operators in training and practice.      Additionally a cost-effectiveness analysis of PROSPECT compared to traditional training     modalities will be executed. A successful training program is expected to lead to a     shortening of the learning curve, reduction in number of errors during real life procedures     and more efficient use of hybrid angio suites. The financial impact of potentially shorter     duration of endovascular interventions will be studied and compared to time investment and     additional costs associated with stepwise, supervised training using VR simulators.   "
100868|NCT01965847|"     Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause     of premature mortality worldwide. Ambulatory blood pressure (BP) monitoring (ABPM) allows for     assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic     BP appears to be the best predictor of cardiovascular disease and all-cause mortality.     Importantly, elevated nighttime BP is a modifiable risk factor; evening dosing of     antihypertensive medications lower nighttime BP and reduces proteinuria. In a large,     randomized controlled trial, evening dosing of antihypertensive medications reduced the     hazard rate for major cardiovascular events by 67%. Findings were similar in the subgroup of     participants with chronic kidney disease (CKD). However, this single-center study was     designed to evaluate cardiovascular outcomes, not progression of CKD. The long-term effect of     nighttime dosing of antihypertensive medications on progression of CKD is unknown.      To address this important gap in knowledge, the investigators plan to conduct a pragmatic,     randomized controlled trial. 3600 participants at risk for progression of CKD who are taking     ≥1 antihypertensive medication once daily will be randomized to morning versus evening dosing     of at least one antihypertensive medication. The purpose of the current study is to obtain     pilot data demonstrating the feasibility of the trial and the efficacy of the intervention.   "
100977|NCT01964417|"     The purpose of this study is to compare the efficacy, acceptability and preparation-induced     mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.   "
101331|NCT01959776|"     Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after     macular hole surgery   "
101505|NCT01957475|"     The aim of the current investigation is to develop new soft and more flexible 2-piece convex     ostomy appliances   "
100869|NCT01965834|"     Multiple myeloma cells are dependent on calcium (Ca2+) for their function. Specifically, Ca2+     is required for the function of the endoplasmic reticulum in which proteins, including     immunoglobulins, are folded prior to their release from the cell. Multiple myeloma cells     secrete large concentrations of immunoglobulins continuously and as result depend on     mitochondria activity to replenish the Ca2+ levels in the endoplasmic reticulum as was shown     in vitro in our lab. Fenofibrate has been shown to inhibit mitochondrial function resulting     in inhibition of protein folding in the endoplasmic reticulum of multiple myeloma (MM) cells     that leads to the induction of a stress signal known as the unfolded protein response and     subsequently apoptosis. The effective anti-myeloma concentrations for fenofibrate are     attainable in the clinical setting as they are in the same range as the effective     concentrations for anti-hyperlipidemic effect. The investigators propose to evaluate     fenofibrate therapy in multiple myeloma patients.   "
100870|NCT01965821|"     Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff     underinflations and overinflations frequently occur in critically ill patients, resulting in     increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to     determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff     pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal cuff     pressure.   "
100871|NCT01965808|"     Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken     at least 4 days apart. One dose will be given without food. One dose will be given with a     high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug     gets into the blood stream. Side effects will be documented. This study will last     approximately 15 days not including screening. Screening is required within 30 days prior to     the start of the study.   "
100872|NCT01965795|"     The purpose of this pilot study is to evaluate the potential effects of whole coffee fruit     concentrate (WCFC, Neurofactor), a product that elevates circulating brain-derived     neurotrophic factor (BDNF), on cognition and mood in healthy adults.      The projected outcome of this study is that self-administration of Neurofactor for 28 days     (or even 14 days) will be associated with an improvement in mood and scores on cognitive     tests, and that the change will exceed that observed with administration of Nutrim (placebo).      Volunteers will be recruited from the greater Los Angeles community. Participants will be     middle-aged nonsmokers, in good health, and between the ages of 40-55 to enhance the chance     of demonstrating pro-cognitive effects. Younger participants, whose cognitive performance is     expected to be higher, may perform at a ceiling level, with less room for improvement by the     product under study.      Participants who call our lab will be told about the study in more detail, and will complete     a 5 minute phone screener to determine preliminary eligibility. After the initial telephone     screening, participants will visit Dr. London's laboratory at UCLA to provide written     informed consent.      The first study visit will be an in-person screening visit to determine full eligibility. The     evaluation will include a psychiatric diagnostic interview, using the SCID, blood tests,     urine samples (to test for drug use and pregnancy). Participants will also be interviewed     about their prior and current drug use, including tobacco use. In addition, participants will     be interviewed about the nature of their employment and physical exercise habits: endurance     training has been shown to increase plasma BDNF in young men.      Participants meeting the inclusion criteria will attend the Semel Institute for Neuroscience     and Human Behavior at UCLA to take part in baseline measurements, and to be randomized to     receive either WCFC or placebo. During the active treatment time (28 days), they will visit     the UCLA Semel Institute on a weekly basis. At each of these weekly visits, questionnaires     regarding compliance will be completed, and blood samples will be taken for assay of BDNF. A     cognitive test battery and mood-rating scales will be completed at baseline and at 14 and 28     days of treatment. At the midpoint assessment (14 days) and at completion of treatment (28     days) blood will be drawn for assay of a blood chemistry panel (as at baseline) as well as     for biomarkers in addition to BDNF.   "
100873|NCT01965782|"     This type of study is called a radiolabeled study. For this study, LY23023703 (study drug)     has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally     occurring radioactive form of the element carbon. This study will help understand how the     drug appears in the blood, urine, and stool after it is administered to healthy men.     Information about any side effects that may occur will also be collected. This study will     last up to 15 days for each participant, not including screening. Screening is required     within 28 days prior to the start of the study.   "
100874|NCT01965769|"     Omitting evaluation of gastric residual contents prior to feeding very premature infants will     increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as     well as decrease the time required for parenteral nutrition.   "
100875|NCT01965756|"     Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive loss of     memory and other cognitive functions. It is the most common cause of dementia in older     adults, affecting approximately 18 million people worldwide, including almost 500,000 in the     Philadelphia tri-state area. After age 65, the incidence of AD rises exponentially, doubling     every five years. By age 85, almost half of us will have AD. In 2030, as many as 7.7 million     Americans could have AD, and by 2050 this number could rise to 11-16 million people. The     annual cost of AD in the United States is about $200 billion. AD-related medical     complications are among the most common causes of death in the elderly population. Despite     these alarming statistics, a cure for AD may not be essential since delaying the onset of     AD by just 5 years could have a profound impact on this disorder by reducing the incidence     and cost of AD by 50% between now and 2050.      AD is difficult to recognize in its earliest stages, in which the principal complaint is     typically an increase in episodes of forgetfulness. This stage is now commonly referred to as     mild cognitive impairment (MCI). Neuroimaging and CSF biomarkers have demonstrated good     accuracy in predicting which MCI patients later convert to AD and which tend to remain     stable or revert to more normal cognition. The diagnosis of AD itself is made when increased     loss of memory and other cognitive abilities (eg, language, praxis, and executive function)     affect daily functioning. As the symptoms of dementia inevitably worsen, patients may become     incapable of even basic activities such as feeding and dressing themselves. The disease     course often spans more than a decade, creating a vast social and financial burden on society     and extracting an immeasurable emotional toll on family members.      Clinical and preclinical evidence is accumulating that brain insulin resistance may play a     role in the pathogenesis and/or progression of Alzheimer's disease and that ameliorating     insulin action in the brain may benefit cognition symptomatically and modify disease     pathology.   "
100876|NCT01965743|"     This study has two goals: 1) to test an approach to helping women who use intrauterine     contraception (IUC) spread the word about this type of long-lasting, highly effective birth     control method among their friends and family and; 2) to test ways of getting in touch with     these women's friends and family so that we can track whether this approach is effective at     spreading birth control information through social groups.   "
100877|NCT01965730|"     This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and     blood transfusion after cardiac surgery without increasing adverse events   "
100878|NCT01965717|"     Endovascular procedures already brought enormous revolution in the process of treatment of     patient with abdominal aortic aneurysm (AAA). It is well defined that early mortality and     morbidity is significantly reduced comparing to open repair. The persistent concern is long     term durability of devices and their success of aneurysm exclusion in order to prevent     rupture. At the moment the best armament to prevent rupture after endovascular exclusion is     the watchful waiting and timely reintervention. The main complication that follows this     procedure and causing catastrophic long term complications is endoleak. The ideal algorithm     to follow up patients after aneurysm exclusion has not been found. In order to reveal     endoleak ultrasound is used more than before, however frequent computerized tomography is     wasting a lot of costs and exposing patients to irradiation and nephrotoxic contrast.      Matrix metalloproteinase activity has been demonstrated in the process of aneurysm     development. Imbalance between MMP and its inhibitors TIMP provokes collagenolytic and     elastolytic activity that is inducing aneurysmatic degeneration of aortic wall. Due to the     previously described connection between aneurysm and MMP activity, it was proved that serum     level of MMP-9 is significantly higher in patients with abdominal aortic aneurysm (AAA).     Also, higher levels of MMP-9 were discovered in patients with inadequate aneurysm exclusion     after endovascular procedure suggesting that degradation of the aortic wall is still ongoing     process, not being the case with successfully excluded aneurysm. There might be a potential     role of MMP-9 serum level as a biomarker of present endoleak after endovascular aneurysm     exclusion.      All published trials have shown correlation between MMP 9 activity and presence of endoleak,     however, no correlation was made between specific types of endoleak and necessity to     reoperation (clinical significance). Additionally there were only four trials presented in     the literature investigating low number of patients.      Since there is possible value of MMP-9 serum level as biomarker of present endoleak, further     studies are necessary. This why we are organizing multicentre trial, that will cover     significant number of patients in order to define        -  Value of MMP-9 as a biomarker of successful initial exclusion        -  Value of MMP-9 level as predictor of aneurysm shrinkage        -  Value of MMP-9 level in patients with increased aneurysm diameter and no visible          endoleak        -  Correlation of the MMP -9 serum level with different type of enoleak        -  Value of MMP-9 as biomarker of successful treatment of endoelak      Material and methods Patient with AAA greater then 55mm in diameter that are candidates for     endovascular repair will be selected. Demographic, anatomical and data regarding the     procedure will be gathered prospectively. Also serum levels of MMP-9 will be measured before     procedure, during the first week before discharge, and after 1,6,12,18,24,36,48 months. On     the same day of measuring MMP-9 level control MSCT and ultrasonography exam will be performed     in order to collect data regarding the success of exclusion and presence of any endoleak with     the accurate measurement of aneurysm diameter changes. Ultrasonography and MSCT exam will be     performed by experienced physicians, also preoperative evaluation of anatomical data.      In case of reintervention additional questionnaire will be filled regarding anatomical and     procedure related data using pre and postoperative ultrasound and MSCT examination, while     MMP-9 levels will be measured before procedure and after the procedure using the same     protocol as for primary procedure.      Statistical analysys Levels of MMP-9 in serum with presence of different types of endoleak     will be correlated one week and 1,6,12,18,24,36 48 months after the procedure Anatomical data     will be correlated with the decrease in MMP-9 level before and after procedure Levels of     MMP-9 in serum after one week and one month will be correlated with further aneurysm     shrinkage Level of MMP-9 in serum with type of endoleak will be correlated Level of MMP-9     before and after reoperation will be compared Level of MMp-9 in serum of patients with     disappearing endoleaks will be followed Level of MMP-9 in serum of patients with new     endoleaks will be followed   "
101101|NCT01962792|"     Phase 1 will be an open-label study. The dose escalation portion of the study is designed to     establish the MTD of ibrutinib in combination with carfilzomib with or without dexamethasone.      Phase 2b will be an open-label, multicenter study designed to evaluate the overall response     rate when ibrutinib is administered in combination with carfilzomib and dexamethasone.   "
100879|NCT01965704|"     The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal     abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug     ondansetron in the mothers prior to delivery and their babies after delivery.      The study is a randomized, double-blind, placebo-controlled study with one half the     mother-baby pairs to receive ondansetron and the other half of the mother-baby pairs to     receive placebo. The pregnant narcotic-dependent mothers will receive an intravenous dose of     study medication prior to delivery; the neonates, after their birth, will receive the same     study medication the mother received every 24 hours for up to 5 days.      The Investigators will follow up with the mother-baby pairs for 10 days after study drug has     stopped and one last follow up, about 30 days after stopping study drug, to learn if the baby     had any symptoms of NAS in that time period.   "
100880|NCT01965691|"     Phenylketonuria (PKU) is an inherited inborn error of an amino acid phenylalanine (PHE)     metabolism affecting 1:15,000 births. It is caused by a decreased activity of an enzyme in     the liver called phenylalanine hydroxylase (PAH) which is important to convert PHE into     tyrosine, another amino acid. Consequently, PHE accumulates in the blood leading to mental     and developmental delays. Nutritional management is the primary choice of treatment that     includes providing sufficient protein in the diet and at the same time restricting PHE.     However the amount of protein to be given is unknown. A new technique called Indicator Amino     Acid Oxidation (IAAO) will be used to determine the protein requirements in children with PKU     (5-18y). The study will help treat and manage these children with sufficient protein to     ensure proper growth and development. Current dietary recommendations range from 35-65 g/day     and is based on factorial calculations.      The investigators hypothesize that the protein requirement in children with PKU will be     higher than the current mathematically calculated recommended intake of 35-65 g/day for the     5-18y children.   "
100881|NCT01965678|"     Aim of this study is to evaluate the effectiveness of osteopathy in changing quality of life     in a large sample of naive patients undergoing osteopathic manipulative treatment.   "
100882|NCT01965665|"     The purpose of this study is to prospectively evaluate the effect of Active Leptospermum     honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and     also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to     published reports of routine standard pin site care.   "
100883|NCT01965652|"     The purpose of this study is to evaluate the long-term safety of naldemedine for the     treatment of constipation due to opioid therapy.   "
100884|NCT01965639|"     The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment     existing standard of care in an effort to (1) improve population level diabetes management,     health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2     Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and quality     of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare costs     associated with Type 2 Diabetes Mellitus.   "
100885|NCT01965626|"     Oseltamivirphosphate is hydrolysed to its active metabolite-the free carboxylate of     oseltamivir. Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of     the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins     on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent     platelet destruction in liver.The project was undertaking by Qilu Hospital of Shandong     University and other 5 well-known hospitals in China. In order to report the efficacy and     safety of oseltamivirphosphate combined with high-dose dexamethasone for the treatment of     immune thrombocytopenia (ITP) with high platelet desialylation level, compared to high-dose     dexamethasone therapy.   "
100886|NCT01965613|"     The purpose of this study is to determine if treatment with Xionix will improve wound healing     for patients with pyoderma gangrenosum.   "
100887|NCT01965600|"     An endotoxin challenge will be administered to healthy subjects to induce production of     inflammatory markers. An investigational drug or placebo will be administered prior to the     endotoxin challenge to assess the effect of the investigational drug on the markers of     inflammation. Safety and tolerability will also be assessed.   "
100888|NCT01965587|"     Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure     alone in the treatment of menorrhagia   "
100889|NCT01965574|"     Preload dependence assessment is difficult during prone position, and to date, no hemodynamic     parameters have been validated to rationalize fluid loading in that position. This study aims     to validate several hemodynamic parameters, using continuous cardiac output by pulse contour     analysis and transpulmonary thermodilution.   "
100890|NCT01965561|"     Normal human adult volunteers wereused to investigate the performance of medical devices     intended to stop junctional bleeding on the battlefield.   "
100891|NCT01965548|"     In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most     frequent source of bleeding in the abdomen.      Historically, splenectomy was the treatment of choice for splenic bleeding. For     exsanguinating patients, open splenectomy is still the proper choice of treatment if the     spleen is a significant source of bleeding. However, for hemodynamic stable patients with     splenic injury, non-operative management (NOM) is an alternative, assuming they have no other     indication for surgery (peritonitis).      Non-operative management includes observation and/or splenic artery embolisation (SAE), but     the indications for observation and SAE varies between trauma centers. The greatest advantage     of NOM is the preservation of splenic function.      In the investigators hospital splenic artery embolisation was introduced in 2007. The     investigators want to describe the treatment of splenic injuries in their hospital, to see if     the number of splenectomies has been recduced after 2007, and to see if SAE has also been     used in transferred trauma patients.   "
100909|NCT01965314|"     Investigators hypothesize that virtual reality based training offers an additional learning     benefit over standard training (using cadaveric dissection and human volunteers) in preparing     novice anaesthetists to perform their first Ultrasound guided Axillary Brachial Plexus     Blockade (USgABPB) in the clinical setting.      Investigators hope that this body of work will aid the development of a visuo-haptic     simulator used to improved training of doctors in performing USgABPB. Ultimately any patient     having this procedure carried out in the future should benefit. In particular it will avoid     the need for novice trainees to practice new techniques on patients.   "
100910|NCT01965301|"     Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)   "
100892|NCT01965535|"     This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)     fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and     tolerability of each regimen as assessed by review of the accumulated safety data.     Approximately 150 participants with genotype 1 HCV infection, who have previously received     treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will     be randomized to 1 of 2 groups.      Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks      Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for     12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks      Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b;     mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy     treatment response (never achieved HCV RNA < the lower limit of quantitation (LLOQ), or     achieved HCV RNA < LLOQ).   "
100893|NCT01965522|"     Investigators plan to carry out a study to investigate two different pills, Vitamin D and     melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with     breast cancer. These pills are inexpensive and have very few side effects. A large number of     studies using cell cultures and animals have shown that both vitamin D and melatonin can help     destroy breast cancer cells. However thoughtful and well-designed studies are necessary on     humans to see if they can decrease the spread of breast cancer, and possibly even prevent     breast cancer. The proposed study aims to understand the anti-cancer activity of vitamin D     and melatonin. This knowledge will assist in creating efficient cancer prevention strategies     for Canadians. This study will include women with breast cancer who are being planned for     surgery, and will assess whether treatment with vitamin D (dose of 2000 IU per day) in a     group of 36 women, or melatonin (dose of 20mg per day) in another group of 36 women, or both     pills together in yet another group of 36 women, reduces the spread of cancer cells when     compared to a fourth group of 36 women who are treated with sugar pills. To do this we will     measure a substance in the blood called Ki67, which provides information about the spread of     cancer. Investigators will compare the Ki67 levels in the 4 groups, and all women will     receive identical appearing pills so they will not know which treatment they received.   "
100894|NCT01965509|"     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)     analogue that created on the basis of the Exenatide and modified by polyethylene glycol     (PEG).      This study aims to evaluate the effective therapeutic concentration range of PEX168, also     decided to observe safety and PK/PD correlation by long-term continuous administration.   "
100895|NCT01965496|"     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)     analogue that created on the basis of the Exenatide and modified by polyethylene glycol     (PEG).      This study aims to evaluate whether the titration mode of administration could reduce the     incidence of adverse reactions of PEX168, also decided to observe long-term continuous     administration of PK/PD correlation.   "
100896|NCT01965483|"     The implementation of a weekly hypofractionated radiation could be an advantageous     alternative. The convenience of less treatment days could cause a greater adherence, decrease     of costs and increase the offer of radiotherapy to major number of patients in underserved     areas.      The purpose of this study is to determine in women with diagnosis of initial breast cancer     undergoing breast-conserving surgery the effects of the adjuvant radiotherapy using a once a     week regimen, with 5 fractions in total. The study will analyze the acute toxicity of     radiation, the patient's self referred quality of life, the cosmetic breast appearance, as     well the oncological safety. It will also be analyzed the viability of this more contracted     regimen in our community setting, regarding the patient's adherence to the treatment.   "
100897|NCT01965470|"     The BCPP study is designed to test the hypothesis that implementing an enhanced combination     prevention package which includes provision of ART to all participants, regardless of CD4     count or HIV disease severity, will impact the HIV/AIDS epidemic by significantly reducing     population-level, cumulative HIV incidence in a defined geographic area over a period of 3     years and will be cost-effective.   "
100898|NCT01965457|"     The term adenoids describes lymphoid tissue on the superior and posterior walls of the     nasopharynx, and their hypertrophy is a common condition of childhood. When enlarged,     adenoids can obstruct the nasopharyngeal airway and cause mouth-breathing, hyponasal voice,     and snoring. In more severe cases, obstructive sleep apnea (OSA) may result, which carries     potential risk of neurocognitive disturbance, growth failure, and heart-lungs disease.     Adenoid hypertrophy can also be associated with otitis media with effusion, possibly through     Eustachian tube dysfunction or chronic adenoidal infection.      Methods for identification of adenoid hypertrophy include the clinical history, examination,     imaging (eg, plain lateral x-ray), or by nasal endoscopy witch enable direct visualization of     the nasal cavity with dynamic evaluation of any nasal airway obstruction.      Objectives :      The aim of this study is to prospectively examine invasive and non-invasive office procedures     to assess adenoids hypertrophy, including clinical history, x-ray imaging, and nasal     endoscopy.      Methods :      Prospective, observational study in pediatric patients aged 2-18 that will be referred to the     otolaryngology pediatric 'Clalit' clinic in Haifa after x-ray imaging and an informed     consent.        1. Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will          be evaluated at the clinic, as described by Paradise grading system.        2. Plain lateral x-rays Plain lateral X-rays of the patients will be evaluated only if the          patients had them at the time of referral. Adenoidal obstruction will be assessed by          Fujioka's Adenoid-Nasopharynx ratio.        3. Fiberoptic nasal endoscopy (FNE) Fiberoptic analysis will be done as an office procedure          using a 2.4mm Storz nasal flexible endoscope following an application of Lidocaine gel          locally into the nostril and on the endoscope distal end. Adenoidal obstruction will be          assessed by Parikh grading system.   "
100899|NCT01965444|"     The objective of this study is to establish required data for SEM Scanner analysis of the     readings given by the SEM Scanner in the target patient population.. In order to better     understand the data this non-invasive scanner provides a collection of data/readings is     required to be collected in a certain population. This will help with clinical interpretation     of the numbers and readings this device will provide.   "
100900|NCT01965431|"     The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined     with faldaprevir on cardiac safety parameters in healthy subjects   "
100911|NCT01965288|"     The aim of this study is to compare the clinical performance of the Biofinity Toric     (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of     daily wear.   "
100912|NCT01965275|"     the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile     Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of     standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）   "
100913|NCT01965262|"     This purpose of this study is to compare the clinical performance and subjective acceptance     of two different daily disposable limbal ring lenses.   "
100901|NCT01965418|"     This research puts liver biopsy as the enrollment screening criteria and the primary efficacy     assessment indicators. Patients at different developmental stages of hepatitis B related     liver fibrosis are respectively diagnosed and treated by Traditional Chinese medicine to     determine optional diagnosis and treatment plan of traditional Chinese medicine to screen the     advantage-treated population and to establish a treatment program, which can save national     medical resources, for clinical application of Traditional Chinese medicine Diagnosis and     Treatment blocking and reversing hepatitis B-related liver fibrosis. The research can help to     build automation pathological analysis and diagnosis systems and non-invasive clinical     assessment criteria and models of liver fibrosis which can be applied in clinical. It can     also help to realize electronic patient data collection and management, to establish patients     management centre and follow-up database. Then it will help to improve clinical efficacy of     being blocked and reversed chronic hepatitis B related liver fibrosis by Chinese medicine     Diagnosis and Treatment program, to reduce the incidence of liver cirrhosis and hepatitis     B-related mortality, to prolong patients' survival and improve patients' quality of life, to     make clinical efficacy, which is about Traditional Chinese Medicine blocking and revering     chronic hepatitis B-related liver fibrosis, increase by 15% or more .   "
100902|NCT01965405|"     In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care     model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the     efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA     that incorporate the current standard of care and prize-based contingency management.     Intervention will be administered in a community-based HIV integrated care clinic in downtown     Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1     will last 4 weeks, and will involve brief intervention to help participants stop smoking. For     phase 2, participants will be assigned to different study arms depending on whether they are     Responders (reduced their smoking) or Non-responders (continued to smoke).        1. Phase 1: We hypothesize that brief high-magnitude prize contingency management will          result in greater reduction in smoking than standard of care alone.        2. Phase 2a: We hypothesize that non-responders who are assigned to contingency management          will be more likely to reduce their smoking throughout treatment and to abstain from          smoking at all follow-up points.        3. Phase 2b: We hypothesize that responders who are assigned to monitoring and          low-magnitude prize contingency management will be more likely to maintain their reduced          or abstinent smoking status at all follow-up time-points.   "
100903|NCT01965392|"     The aim was to assess whether nursing interventions based on Health Educational Programs for     primary informal caregivers of dependent patients may improve their quality of life,     decreasing emotional burden and increasing caregiving knowledge, in order to better meet     patients' basic needs.   "
100904|NCT01965379|"     Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater     risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and     bone disease .      The serum phosphorus level can be controlled by a combination of factors, such as: reduction     of ingestion, reduction of intestinal absorption with chelating agents and increase in     elimination by dialysis.      The purpose of this study is to evaluate the effect of dietary intervention consisting of the     restriction of industrialized foods with phosphorus additives in chronic kidney disease     patients treated with hemodialysis.   "
100905|NCT01965366|"     Evidence from preliminary studies suggests that people with PTSD have heightened fear     responses and that cortisol suppression reduces this heightened fear. Research has shown the     drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians     with PTSD. This current research proposal represents a blinded, randomized,     placebo-controlled efficacy study with the goal of determining whether a drug that suppresses     the stress hormone cortisol will increase the efficacy of exposure therapy. Specifically, it     is proposed that a dose of DEX, given the night before (approximately 10 hours before) each     of 5 to 11 individual virtual reality exposure (VRE) therapy sessions, will significantly     enhance the rate of response and possibly the efficacy of treatment. Participants will be     treated until they have experienced at least a 70% reduction in PTSD symptoms from baseline     or up to 12 sessions or until they and their therapist agree treatment should be terminated,     a minimum of 6 sessions to a maximum of 12 sessions. Comprehensive multi-modal outcomes will     be assessed by independent assessors blind to subject condition on interviews, self-report     measures, and psychophysiological measures. Participants will be assessed pre- and     post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.   "
100906|NCT01965353|"     This research study is evaluating an investigational drug called panobinostat (LBH589) in     combination with the standard agents lenalidomide, bortezomib, and dexamethasone as a     possible treatment for multiple myeloma.   "
100907|NCT01965340|"     Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and     respiratory failure that used to be the major cause of mortality have progressively been     replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs     several weeks, or even months after injury as a consequence of sepsis usually caused by     multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with     topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn     trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR     bacteria.      Correct prescription of anti-infective agents could be one way to curb the steadily     increasing development of multidrug resistance. Administration of antibiotic to burn patient     is complex: they frequently suffer from kidney dysfunction, they usually experience     tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular     compartments, they often are hypo-albumin and protein-emic, and finally they present with a     profoundly modified metabolism. All those aspects make this particular population of patients     at high risk of both under or over prescription.      Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic     Drug Monitoring, has been introduced to clinical practice for several decades primarily to     avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the     increasing availability of detection techniques, the number of drugs that can be measured in     the plasma of patients has grown tremendously over the last decade. As a consequence, it is     currently possible to monitor drug concentrations not only to prevent toxicity, but also to     improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic     prescription in different populations of hospitalized patients, including critically ill     patients, with a direct impact on outcome.      Such studies amongst burn patients are however lacking, although this particular population     is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM     could improve antibiotic prescription in this peculiar population. To this end, we propose to     implement a 3-year prospective, randomized, mono-centric, clinical trial that will analyze     the impact of systematic TDM on anti-infective agent prescription amongst burned patients.   "
100926|NCT01965080|"     A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma      Hypothesis: Treatment With Exemestane can give a response rate of at least 30%   "
100914|NCT01965249|"     The major long term complication of abdominal wall closure after a median laparotomy is the     development of an incisional hernia. Several suture technique and suture material have been     used but the incidence of this complication still lies between 9 -20%. Synthetic suture     material which have become available over the last decades have the advantage that they are     degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of     their initial strength already after 14-30 days and may not be the optimal suture material     for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long     absorption profile, high elasticity and with a superior initial strength. Therefore, the     ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence     of incisional hernia using the extra-long term absorbable, elastic, monofilament suture     (Monomax®).   "
100915|NCT01965236|"     The objective of the present study is to asses the effectiveness of the aorta-ventricular     coupling according to low and high sodium intake in 28 controled hypertensive patients.   "
100916|NCT01965223|"     The main purpose of this study is to determine the safety (defined as number of participants     experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated     radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.   "
100917|NCT01965210|"     Acute effects on appetite and metabolic function have been observed for whole-grain rye     cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a     whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable     dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on     subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients     in the blood and products from bacterial fermentation of dietary fibre, and to relate this to     the different composition of the breakfasts.   "
100918|NCT01965184|"     This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive     behavior such as anger and aggression in children and adolescents. CBT will be compared to     Supportive Psychotherapy (SPT) and participants of this study will be randomly assigned (like     the flip of a coin) to receive CBT or SPT. Participants will be also asked to complete     functional magnetic resonance imaging (fMRI) and electrophysiological (EEG) tasks     (recordings/images of brain activity) before and after treatment. CBT is a behavioral     intervention that consists of 12 one-hour long, weekly sessions. During CBT children are     taught various skills for coping with frustration and parents are taught various strategies     for managing situations that can be anger provoking for their child. This study is conducted     to examine whether reduction of behavioral problems including anger outbursts, irritability,     aggression and noncompliance after CBT may be paralleled by changes in areas of the brain     responsible for emotion regulation and social perception.   "
100919|NCT01965171|"     Red cell transfusions are an important part of supportive cancer therapy. The iron in the     transfused blood may build up in the body since the human body has no way to get rid of extra     iron. Iron tends to build up in the liver and the heart muscle. It is unknown if iron     build-up is present many years after completing cancer therapy. It is also not known if extra     iron causes harm to internal organs. Researchers at St. Jude Children's Research Hospital     (SJCRH) want to understand if iron build-up (called iron overload) exists in survivors of     leukemia. They also want to know if iron overload can cause injury to your organs if it is     present.      Liver iron accumulation has been documented in childhood cancer survivors, however, it is not     known if iron associated organ toxicity is contributing to the long-term morbidity that has     been well documented among these survivors. This study will investigate the prevalence of     iron overload and the association of tissue iron burden with markers of organ dysfunction in     leukemia survivors. This study will determine the prevalence of iron overload among long-term     leukemia survivors that underwent blood transfusion. This study will use blood and magnetic     resonance imaging (MRI) testing to determine iron overload of specified organs. Understanding     the prevalence of iron overload could impact surveillance practices in leukemia survivors.      PRIMARY OBJECTIVE:        -  To determine the prevalence of iron overload in the liver [liver iron concentration          (LIC) >3mg/g using R2* MRI measurements] and in the heart (T2* <20 ms) among long-term          leukemia survivors transfused with ≥50ml/kg of packed red blood cells.      SECONDARY OBJECTIVES:        -  To examine the relationship between hepatic, cardiac, and endocrine dysfunction and          transfusionally acquired iron overload as defined by R2* and T2* MRI among survivors of          pediatric leukemias.        -  To investigate the association between serum ferritin, transferrin saturation,          non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron          overload.   "
100920|NCT01965158|"     The purpose of this study is to evaluate the efficacy and safety of naldemedine in the     treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who     are not using laxatives.   "
100921|NCT01965145|"     The objective of this study is to demonstrate the superiority of gevokizumab as compared to     placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis     exacerbations   "
100922|NCT01965132|"     We plan to establish a nationwide Biologics Registry (in the form of an inception cohort) to     study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic     arthritis patients receiving biologic agents.As this registry is to observe the real world     use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is     planned.   "
100923|NCT01965119|"     The purpose of this study is that ruxolitinib may be a possible treatment option for relapsed     or refractory patients with Hodgkin and primary mediastinal large B-cell lymphoma.   "
100924|NCT01965106|"     This study will assess any side effects that may occur when QPI-1007 is injected into the eye     in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the     body to clear the drug. This study will also test whether QPI-1007, injected into the eye,     helps prevent both structural damage of the nerve tissue in the eye and the loss of visual     function in subjects with acute primary angle-closure glaucoma.   "
100925|NCT01965093|"     The most serious peri-operative respiratory event (PRE) in pediatric anesthesia is     desaturation or hypoxemia which could lead to cardiovascular collapse or cardiac arrest.     Intermittent hypoxic episode especially in infants are also associated with impaired growth,     longer-term cardiorespiratory instability and poor neurodevelopmental outcome.12 The     mechanism of peri-operative desaturation occurring in normoxia infant brain is quite similar     to overabundance of oxygen in the acutely hypoxic infant by using 100% oxygen or hyperoxia     for resuscitation of acutely asphyxiated infants which can generate excessive neurotoxic     compounds and increase oxidative stress markers.17 Anesthetic agents which involve     gamma-aminobutyric acid (GABA)receptors eg; volatile agents, midazolam and     N-methyl-D-aspartate receptor (NMDA) receptors eg; nitrous oxide, ketamine can cause neuronal     apoptosis, neuronal necrosis, neuronal cell death and memory deficit in rat pups. Moreover,     prolonged anesthetic exposure, irrespective of open heart surgery, can influence     neurodevelopment of the brain in rodents.17 However, the evidence for anesthetic agents     causing apoptosis and neurodegeneration in human neonatal brain is still not clear.      Thus, peri-operative desaturation occurred in young age regardless of severity combined with     general anesthesia might possibly affect the long-term impact regarding growth and     neurodevelopmental outcome in infant or intelligence outcome in older children. In our study,     we are interested in looking at the intelligence outcome, which is a part of neurodevelopment     outcome, in preschool children aged ≤ 5 years who developed desaturation peri-operatively.     Because we include a wide range of age between newborn to five years old to test     neurodevelopment outcome in older children, the intelligence outcome may be more appropriate     and can be applied to infants and younger ages. Therefore, the objective of study was to     compare intelligence outcome between children who developed peri-operative desaturation and     children who did not develop PRE.   "
100927|NCT01965067|"     The primary efficacy endpoint is the time from the start of administration of sugammadex to     recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic     count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C     and 35°C, and compared with the normal thermal condition.      Secondary endpoints include time from the start of administration of sugammadex to recovery     of the TOF ratio to 0.7 or 0.8 in both groups, vital signs [heart rate and blood pressure] at     pre-reversal, post-reversal, recovery and post-anesthetic visit, the incidence of residual     neuromuscular blockade, post-operative nausea and vomiting (PONV) and adverse events during     mild hypothermia and the normal thermal condition.      We hypothesize that mild hypothermia with core temperatures between 34.5°C and 35°C diminish     the efficacy of sugammadex.   "
100928|NCT01965054|"     Intrahepatic cholestasis of pregnancy (ICP) is a unique disease of the liver resulting in     abnormal bile acid levels and liver function. The incidence of ICP ranges from 0.1 - 15.6%.     Women diagnosed with ICP most often present with itching, which may be severe. More     concerning, however, is the impact of ICP on adverse fetal and pregnancy outcomes, including     preterm delivery, meconium exposure, fetal demise, and increased neonatal respiratory     complications. The risk for fetal demise has been estimated to be 1-3%. The mechanism of     fetal demise in ICP is unknown, and therefore cannot be reliably predicted. There is evidence     to suggest that extremely elevated bile acids levels are associated with worse fetal     outcomes, particularly levels greater than 40 μmol/L.      Ursodeoxycholic acid (UDCA) has anticholestatic effects, and is used to treat a variety of     cholestatic liver diseases. Many studies have demonstrated superiority of UDCA over other     agents, including dexamethasone and cholestyramine, for relief of maternal pruritus,     improvement in transaminitis, reduction in serum bile acid concentrations, and improved     pregnancy outcomes. As a result, UDCA is now widely used as first-line treatment for     symptomatic relief in patients with ICP.      Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are two omega-3 long chain     polyunsaturated fatty acids found in fish. DHA is known to play a key role in early fetal     brain development, and has been associated with modest beneficial effects on     neurodevelopmental and cognitive outcomes in children. In neonates with parental     nutrition-induced cholestasis (PN-cholestasis), parental fish oil has been shown to be     hepatoprotective not only for treatment of PN-cholestasis, but for prevention of cholestasis     in premature infants at risk for the disease. Our hypothesis is that fish oil supplementation     with DHA in women with ICP who are treated with UDCA will increase the rate of decline in     serum total bile acid levels.      The incidence of ICP at a single hospital center in Queens, NY is estimated to be 5%     secondary to a high concentration of patients from high-risk ethnic groups. High risk     patients with bile acid levels greater than or equal to 40 μmol/L are managed aggressively     with inpatient admission for continuous fetal monitoring, treatment with UDCA, and serial     total bile acid levels weekly. These are patients are routinely offered early delivery after     documented fetal lung maturity between 36 and 37 weeks gestation, or for any signs of fetal     distress. This study is a prospective randomized controlled trial comparing weekly serum     total bile acid levels in women admitted for inpatient management of ICP among women     supplemented with a standard prenatal vitamin versus supplementation with a prenatal vitamin     and DHA.   "
100929|NCT01965041|"     Adult-onset vitelliform detachments associated with pattern dystrophy is a genetic disorder     that carries visual implications that most commonly affect the macula (area in the eye near     the retina that is essential for sharp central vision). Adult onset vitelliform detachments     have an accumulation of material on the outer retina. Over time, the abnormal accumulation of     this material can damage cells that are critical for clear central vision. As a result,     people with this disorder often lose their central vision, and their eyesight may become     blurry or distorted.   "
100930|NCT01965028|"     Stimulation of the left and right auditory cortex with daily transcranial random noise     stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.   "
100931|NCT01965015|"     The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial     filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA)     class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to     enable a first evaluation of the safety and performance of the V-Wave shunt implant when     implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with     intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant     (baseline) status.   "
100932|NCT01965002|"     The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate MR     guided focused ultrasound surgery in the treatment of soft tissue tumors of the extremities.   "
100933|NCT01964989|"     Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus     Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months     of Age.   "
100934|NCT01964976|"     To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina)     and biguanides in participants with type 2 diabetes mellitus who responded inadequately to     treatment with biguanides in addition to diet therapy and exercise therapy.   "
100935|NCT01964963|"     The purpose of this study is to examine the safety and efficacy of long-term treatment with     alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical     setting.   "
100936|NCT01964950|"     The purpose of this study is to examine the safety and efficacy of long-term combination     therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes     mellitus who responded inadequately to treatment with sulfonylurea in addition to diet     therapy and exercise therapy.   "
100937|NCT01964937|"     This study will evaluate the safety and immune response to five different combinations of     three HIV vaccines in healthy, HIV-uninfected adults.   "
100938|NCT01964924|"     This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene     homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast     cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or     large amounts of human epidermal growth factor receptor 2 [HER2/neu] protein) that has spread     to other places in the body. Trametinib and Akt inhibitor GSK2141795 may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
100948|NCT01964794|"     Clinically relevant biomarkers for warfarin identified in this study will provide crucial     leads for subsequent studies to assess their predictive value during anticoagulant therapy.     This knowledge will aid stratifying risk among patients to improve therapeutic outcomes and     decrease adverse drug events and associated health care costs. Collectively, these efforts     will provide a critical foundation for future research using a metabolite biomarker strategy     in a clinical setting to revolutionize warfarin therapy. Through its application, a real−time     assessment of warfarin metabolism for each patient could lead to a truly personalized dosing     strategy and improve patient safety for this life−saving drug.   "
101140|NCT01962272|"     Background and aims: Cancer-related malnutrition is multifactorial and related to a bad     prognosis. The aim of this study was to investigate the effect of intensive, individual     dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-,     gastric-, or esophageal cancer.   "
100939|NCT01964911|"     Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in     hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary     for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are     responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years     of age, with history of vascular disease, and therefore with a higher risk of adverse event.     Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer     extension and ischemia.      This is why pain management is one of the main challenge in treatments of these ulcers.      Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic     surgery. Few adverse events and rare serious adverse events related to local anesthesic are     reported (respectively <1% and <1/1000), and few adverse events related to catheter are     reported (<1%). Its benefits have been proved on post-operative pain management and     reeducation.      The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in     patients with hypertensive leg ulcer, during hospitalization.      Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic     nerve block with ropivacaïne 0,2%, during 7 days.      Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during     wound care, maximal and mean. These datas will be collected over two 3-days period : the     first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain     intensity of the patient ; and the first 3 days of ropivacaïne treatment.      The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when     receiving ropivacaïne.      Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure     (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.   "
100940|NCT01964898|"     Smoking and depressed mood are both predictive of mortality following Acute Coronary     Syndrome. However, to date, no counseling treatment has been designed to target smoking     cessation and manage mood in this population. This trial will test such a treatment based on     Behavioral Activation, an approach that has shown promise as an integrated treatment for     smoking and mood management in other populations.   "
100941|NCT01964885|"     IQP-AS-105, is a food supplement derived from garlic (Allium sativum). The objective of this     study is to evaluate the possibilities of clinical use of IQP-AS-105 as a preventive     medicine, based on its ability to enhance the immune system responses   "
100942|NCT01964872|"     The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and     pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618     administered for 7 consecutive days in healthy adult male participants.   "
100943|NCT01964859|"     This research is being done to determine if investigators can change skin from one type to     another. Specifically, investigators are interested in making normal skin into the thicker     skin found on our palms and soles.   "
100944|NCT01964846|"     The general objective of this project is to investigate the acute effect of consuming a     dietary supplement combining resveratrol and curcumin on the inflammatory response following     the consumption of a high-fat meal in healthy subjects with slightly elevated waist     circumference.      The study will be undertaken according to a double-blind, cross over, randomized, placebo     controlled design and will be conducted at the Institute of Nutrition and Functional Foods     (INAF) of Laval University. The study will involve a total of 20 healthy subjects (10 men and     10 women. Included subjects will undergo an 6-hour oral fat tolerance, on two separate     occasions (one time following dietary supplement consumption and one time following     consumption of a placebo). The two test days will be separated by maximum of two weeks. The     outcomes are the changes in the plasma levels of inflammatory cytokines in their gene     expression.   "
100945|NCT01964833|"     The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM     is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic     control and increases proteins found in the acute phase of inflammation. The gold standard     for the treatment of periodontal disease is oral hygiene orientation, scaling and planing.     Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to minimize     the prescription of antibiotics, photodynamic therapy (PDT) has been studied as an     antimicrobial technique and has demonstrated promising results. The aim of the proposed study     is to determine whether PDT as a complement to periodontal therapy (PT) is helpful in the     metabolic control of individuals with type 2 diabetes and the reduction of acute phase     inflammatory markers. The patients will be randomized using a proper software program into     two groups: 1) PT + placebo PDT or 2) PT + active PDT. All patients will first be examined by     a specialist, followed by PT performed by two other healthcare professionals. At the end of     each session, PDT (active or sham) will be administered by a fourth healthcare professional.     The following will be the PDT parameters: diode laser (660 nm); power output = 110 mW;     exposure time = 90 seconds per point (9 J/point); and energy density = 22 J/cm2. The     photosensitizer will be methylene blue (50 µg/mL). The patients will be re-evaluated 15, 30,     90 and 180 days after treatment. Serological exams with complete blood count, fasting     glucose, glycated hemoglobin and crevicular fluid exams to screen for tumor necrosis factor     alpha, interleukin 1, interleukin 6, osteocalcin, osteoprotegerin/RANKL will be performed at     each evaluation. At baseline and 180 day periapical radiographs will be performed to evaluate     the alveolar bone crest level. The data will be statistically evaluated using the most     appropriate tests.   "
100946|NCT01964820|"     Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans     with depression receive adequate treatment, and one-third of those receiving treatment do not     benefit. In this pilot project investigators will bring together two approaches that have the     promise to reach large numbers of depression sufferers: a skills-based intervention for     increasing positive affect and experiences in depressed individuals, delivered in an     inexpensive self-paced mobile format. The study will make use of smartphone technology to     improve conventional outcome measurement via in-the-moment emotion sampling and mobile     assessment of heart rate variability, a predictor of cardiac health that may mediate some of     the health effects of depression. The aims are: 1) Retool the existing web-based positive     emotion intervention for use on smartphones, with innovative exercises that help participants     bring the skills they are learning into real- life situations; 2) Measure heart rate     variability and emotions using existing smartphone software; and 3) Perform a randomized     pilot trial of the mobile intervention on individuals with clinical depression recruited     online.   "
100947|NCT01964807|"     The overarching goal of this project is to develop a panel of cardiovascular risk biomarkers     that can detect differences in the cardiovascular safety of various tobacco products, whether     conventional, new or emerging, in order to help the FDA with the task of regulating them.     This will be achieved through 4 aims:      Aim 1: Determine the relative contributions of nicotine and combustion products to the     cardiovascular risk of active cigarette smoking.      Aim 2: Determine which cardiovascular risk biomarkers are affected by exposure to secondhand     smoke.      Aim 3: Determine the cardiovascular risk of smokeless tobacco use. Aim 4: Determine the     cardiovascular risk of electronic cigarettes and the respective contributions of nicotine and     electronic cigarette vapor.   "
101178|NCT01961778|"     The two treatment modalities under investigation are clinically equivalent (non-inferior) to     each other for the endoscopic treatment of Barrett's esophagus with HGD and/or early     esophageal adenocarcinoma.   "
131776|NCT01560169|"     This is an evaluation of celiac-specific patient reported outcome instruments in celiac     disease patients.   "
100949|NCT01964781|"     After surgical procedures, interventions to reduce postoperative pain and bleeding are of     great importance. In this study, the effect will be investigated of smearing common drugs,     which are designed for injection, directly onto the raw wound surface (topical application)     created during surgery. Topical application allows a small amount of drug to reach a large     wound area, higher drug concentration in the exposed wound surface but very low concentration     in the body, and no risk of injury from needles. Although beneficial effects of such an easy     and low-cost intervention would be expected, the investigators have found no previous reports     on blinded and controlled studies.   "
100950|NCT01964768|"     A Phase III study to determine the sensitivity and specificity of three solutions of     different allergen extracts for diagnosis by skin prick-test:        -  5 Grasses pollen,        -  Birch pollen,        -  Dermatophagoides pteronyssinus mite   "
100951|NCT01964755|"     By combining a variety of agents that potentiate Zidovudine (ZDV), the investigators hope to     induce remission in this generally fatal disease. Most therapies for aggressive B cell     lymphomas are based upon intensive chemotherapeutic regimens, expensive modalities (bone     marrow transplant, Rituximab), or experimental approaches (gene therapy, cytotoxic T cell     infusion) that are difficult to implement in heavily pre-treated patients. Therapy for     relapsed aggressive B cell lymphomas is very poor. Even curable lymphomas such as Burkitt     Lymphoma (BL) and Hodgkin lymphoma are extremely difficult to treat in relapse and/or after     stem cell transplant failure. The investigators propose a novel therapeutic approach that     exploits the presence of Epstein-Barr virus (EBV) in lymphomas; antiviral mediated     suppression of NF-kB and disruption of viral latency.   "
100952|NCT01964742|"     The treatment of HCV (hepatitis C virus) infection has made significant progress over the     past decade with the therapy combining pegylated interferon (Peg-IFN) to ribavirin (RBV). The     cure of HCV infection which consists to obtain a sustained virological response (SVR)     (undetectable HCV RNA 24 weeks after end of treatment) is reached in more than 50% of     patients infected with HCV. However, this rate is much lower, around 30 to 40% in HIV-HCV     co-infected patients and sometimes can be less than 20% for patients infected with HCV     genotype 1. Haemolytic anemia is a dose-limiting adverse effect which occurs frequently under     RBV therapy. RBV-induced anemia represents the main cause of treatment discontinuation or     dose reduction of RBV, thus limiting the chances of achieving a SVR. RBV has a large     inter-individual pharmacokinetic variability and a relationship between the occurrence of     anemia and RBV concentration was clearly demonstrated. However, other factors, including     genetic factors, could be predictive of hematotoxicity and/or a better efficiency. In     particular, IL-28B polymorphism analysis, in patients infected with HCV genotype 1, before     starting antiviral therapy could predict the response to treatment (positive predictive     value). The genetic polymorphism of inosine triphosphate pyrophosphatase (ITPA) is also     strongly associated to a protective effect towards the RBV-induced-anemia. But most of these     data are issued from studies performed in a Japanese HCV mono-infected population treated     with Peg-IFN-RBV therapy for which there is no other causal variant that the rs1127354. Only     few studies are reported in the literature in caucasian HIV-HCV co-infected patients.     Moreover, data on RBV plasma exposure are very scarce in all these studies showing an impact     of the ITPA polymorphism on the occurrence of anemia. In addition, others polymorphisms of     SCL29A1/A2 and SCL28A2/A3 coding for RBV transporters, ENT (equilibrative nucleoside     transporter) et CNT (concentrative nucleoside transporter) would be associated to either     rapid virological response or anemia in HCV infected patients treated by Peg-IFN plus RBV. No     study considering both polymorphisms of ITPA, IL-28B, SCL29A1/A2 and SCL28A2/A3 genes and RBV     plasma exposure data has so far been conducted in HIV-HCV co-infected patients.      Thus, it would be interesting in a first time to assess the impact of the ITPA polymorphism     on both the RBV plasma exposure and the protective effect towards RBV-induced anemia in     HIV-HCV co-infected patients. This study could be helpful to the literature for possible     further RBV dose adjustments according to ITPA activity.      Then, it would be relevant to further complete these data by assessing other genetic     polymorphisms as IL-28B, SCL29A1/A2 and SCL28A2/A3 and thus evaluate the overall     pharmacogenetic relationships towards RBV-induced anaemia and/or virological response to a     Peg-IFN/RBV therapy.   "
100953|NCT01964729|"     The purpose of this study is to investigate if rTMS may have a positive impact on pain     thresholds and cortical excitability in subjects with chronic musculoskeletal diseases of     complex cranio-cervical-mandibular with myofascial component.   "
100954|NCT01964716|"     This study will compare the immune responses of the infants who have been given 13vPnC in the     mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in     the single-dose syringe formulation.      It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all     infants who are vaccinated.   "
100955|NCT01964703|"     The purpose of this study is to determine whether Rubus occidentalis extract could improve     fasting or postprandial serum glucose levels, and related metabolic markers among patients     with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).   "
100956|NCT01964690|"     Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very     interesting to detect those situations. Usually, lactate used is arterial but results are     often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some     analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.      We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect     earlier those infections states and we want to find the most accurate site to detect severe     sepsis (capillary, venous or arterial sample).   "
100957|NCT01964677|"     The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device     for the palliation of pain in patients with bone metastases.      Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound     to palliate pain caused by bone metastases. The main palliative mechanism of the method is     due to local bone denervation, caused by the heat denaturation of the periosteum layer in the     treated area. The importance of this therapy is that it offers a non-invasive, focal therapy,     avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the     need for needle insertion as with radio-frequency(RF)ablation.      The study hypothesis is that MR-HIFU will be effective in treating the pain associated with     bone metastases   "
100958|NCT01964664|"     The purpose of this protocol is to (1) Determine whether a one-on-one mindfulness meditation     intervention or audio training improves performance on an adaptive communication system that     utilizes brain-computer interface (BCI); and (2) Determine whether the intervention reduces     stress in subjects with severe speech and physical impairments (SSPI).      Hypothesis: The group of subjects randomized to the mindfulness meditation training will     improve BCI performance and stress levels more than the audio control group.   "
100959|NCT01964651|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral     dose administration.   "
101210|NCT01961362|"     To enhance understanding of supplemental oxygen—its utility in and adoption by patients with     pulmonary fibrosis—by examining how patients perceive it and by determining how perceptions     and patient-centered outcome measures change from before to after supplemental oxygen is     prescribed.   "
109334|NCT01854905|"     This is an observational, study of dry eye in patients at the consultation visit prior to     LASIK surgery. There is no treatment administered or intervention during the study.   "
100961|NCT01964625|"     Graft versus Host Disease (GvHD), in both its acute and chronic forms, is the major intrinsic     complication of allogeneic hematopoeitic stem cell transplant (allo-HSCT). Moreover, chronic     GvHD may be regarded as a late effect of cancer therapy, and the severity of chronic GvHD     is the chief determinant of long-term survival following allo-HSCT. Unfortunately, the     investigators understanding (and thus management) of chronic GvHD is not optimal; a recent     NIH Consensus Conference has defined inadequacies in virtually all facets of chronic GvHD     management. Notably for this study, the lack of suitable biomarkers compromises diagnosis,     staging and therapeutic response evaluation of chronic GvHD - and also hinders better     understanding of the biology of this process.      In particular, the activity of chronic GvHD is often difficult to discern, potentially     causing either undertreatment, with the risk of morbidity and/or mortality due to     uncontrolled chronic GvHD, or possibly overtreatment, with potent ISTs causing unnecessary     toxicity. Obviously, the development of reliable biomarkers of chronic GvHD activity would be     a very useful advance in addressing this problem, as well as other facets of management not     addressed due to certain limitations, as detailed herein.      Potentially, certain imaging technologies could address this problem. To date, imaging     technology has been used only sporadically in chronic GvHD and is not an integral part of     routine assessments. However, and despite its nonspecific nature, certain inflammatory     features of some chronic GvHD cases, plus clinical similarity to certain autoimmune diseases     in which functional imaging has been tested in research trials - (and perhaps notably), a     limited experience in acute GvHD - the investigators postulate that Positron emission     tomography - computed tomography (PET-CT) scans may be useful as a biomarker of disease     activity in chronic GvHD. This protocol is an initial effort to that end.   "
100962|NCT01964612|"     Patient with chronic disease learning of a chronic illness quickly changes the way they     encounter in physiological, psychological and social aspects. The investigators research     purposes will use the meta-cognitive approach to explore adjustment to life-threatening     illness (ex. hypertension and diabetes) of patients may find the important factors in their     coping process.   "
100963|NCT01964599|"     The primary physiological impacts of fiber intake include the gastrointestinal effects of     stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT).     Fermentation of resistant starches by microbiota increases bacterial numbers, which increases     fecal bulk and may impact frequency and transit time. The purpose of this study is to     determine the effects of resistant potato starches (potato fiber) on stool frequency, transit     time and microbiota in healthy individuals.   "
100964|NCT01964586|"     It is very important to decrease the bleeding during nasal septoplasty in order to increase     the visibility of the surgical site. Our primary goal was to investigate the effects of     dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and     postoperative analgesic consumption.   "
100965|NCT01964573|"     The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose     applications of the Rotigotine transdermal patch in healthy young male and female Korean     subjects to be submitted to MFDS for new drug application approval.   "
100966|NCT01964560|"     Study to evaluate the long-term safety and tolerability of Lacosamide (LCM) administered in     addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥1 month to ≤18     years who currently have uncontrolled partial onset seizures.   "
100967|NCT01964547|"     A study to compare the change in cognitive performance and psychological status of patients     with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to     existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to     evaluate the effect of Sativex on mood and spasticity and to assess the safety and     tolerability of Sativex.   "
100968|NCT01964534|"     To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.   "
100969|NCT01964521|"     An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation     to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer     Ag as intended.   "
100970|NCT01964508|"     Thyroid cancer is the most common endocrine malignancy and its incidence is rapidly     increasing. Palpable thyroid nodules are very common, affecting up to 5% of the general     population. Nevertheless, only 5% of the thyroid nodules harbor malignancy, hence the obvious     need to accurately characterize these nodules. Ultrasound guided fine needle aspiration     biopsy (FNAB) is the most important tool in assessing the nature of thyroid nodules, however,     in up to 30% of the biopsies the results are indeterminate. In this proposal, we hypothesize     that leftover cells in the FNAB needle may be utilized for molecular analysis with an     established microRNA panel and distinguish between malignant and benign lesions. Despite     established studies on the diagnostic utility of microRNAs in thyroid nodules, the effect of     microRNAs on specific target genes involved in thyroid cancer is poorly studied. In this     proposal we hypothesize that the microRNAs identified in our panel will affect intracellular     pathways by regulating target genes that are involved in thyroid tumorigenesis. We present     preliminary data that confirms that microRNA panel may identify malignancy in thyroid     nodules. In aim 1 we will identify the expression profile of miRNAs in the different thyroid     cancers. We will statistically quantify the threshold of miRNA dysregulation for malignancy     on a large number of tumor and benign samples. This will serve as matrix for defining     malignancy on the FNAB samples. In aim 2 we will establish a reliable reproducible method to     extract RNA from cells left over in FNAB samples. Our preliminary data support the     feasibility of the method and it has not been described previously. This will be the first     study that will compare cytology results and microRNA panel analysis on the very same FNAB     cells. It will mimic the exact clinical scenario that such microRNA panel can be utilized in     the future. Finally, in aim 3 we will characterize the effect of microRNAs on target genes     expression. We will identify possible target genes from bioinformatics databases and will     perform quantitative measurement of mRNA level of target gene by real time PCR and     immunohistochemistry. These studies will hopefully support the utility of microRNAs as a     diagnostic tool to accurately identify malignancy in thyroid FNAB leftover cells and point     out possible target genes for future therapeutic approaches. This could impact many patients,     as thyroid cancer is the 5th most common cancer in women, and the most rapidly growing     malignancy in both men and women.   "
100971|NCT01964495|"     The purpose of this study is to evaluate two different treatment strategies in patients     admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize     treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be     effective in reducing the length of antibiotic treatment.   "
100972|NCT01964482|"     The project aims to investigate the clinical value of simple strength training during     hospitalization and after discharge as part of an enhanced recovery programme for acutely     admitted older medical patients, in order to prevent mobility decline following acute     hospitalization.      Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained     funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve     sufficient power to look more deeply into our secondary outcomes. This will constitute a     secondary part of the trial (started Nov. 2016). The primary trial report will include data     for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence,     the primary completion date for part 1 was April 2016 and the study completion date for part     1 was Oct 2016. The trial status is still recruiting although this applies to part 2 of the     study.   "
100973|NCT01964469|"     This study is to compare Smart phone mobile device and/or web based application asthma action     plan to the standard of care paper based asthma action plan within an asthma program. The     Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application     improves asthma related quality of life more than conventional best practice   "
100978|NCT01964404|"     Substance use disorders are strikingly common in patients with schizophrenia and contribute     to its morbidity and cost to society. We have proposed a neurobiological formulation     suggesting that cannabis and other substance use in these patients may ameliorate a     dysfunction in the brain reward circuit(thus serving a self-medication function), while     also worsening the symptoms and course of schizophrenia.      In this translational research proposal, based on our formulation, we seek to confirm and     expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid     agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring     cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in     these patients and, thereby, provide evidence in support of the role of cannabis as a     self-medication agent for them. Also, by also testing the full range of effects produced by     dronabinol (effects on brain reward circuitry assessed with task-based function MRI and     resting state connectivity), as well as on reward responsiveness, mood, craving, cognition,     psychiatric and extrapyramidal symptoms), we will provide clues as to whether dronabinol     should be tried in low doses as an adjunctive agent (with an antipsychotic medication) to     limit cannabis use in patients with schizophrenia.      Substance use disorders are strikingly common in patients with schizophrenia and contribute     to its morbidity and cost to society. We have proposed a neurobiological formulation     suggesting that cannabis and other substance use in these patients may ameliorate a     dysfunction in the brain reward circuit(thus serving a self-medication function), while     also worsening the symptoms and course of schizophrenia.      In this translational research proposal, based on our formulation, we seek to confirm and     expand upon our pilot data suggesting that cannabis and the cannabinoid agonist dronabinol,     given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will     in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby,     provide evidence in support of the role of cannabis as a self-medication agent for them.     Also, by also testing the effects produced by dronabinol (effects on brain reward circuitry     assessed with task-based function MRI and resting state connectivity), as well as on reward     responsiveness, mood, craving, cognition, psychiatric and extrapyramidal symptoms), we will     provide clues as to whether dronabinol should be tried in low doses as an adjunctive agent     (with an antipsychotic medication) to limit cannabis use in patients with schizophrenia.      This study will involve 8 groups of 25 participants each. Groups 1-3 will have diagnoses of     schizophrenia and cannabis use disorder; Group 4 will have schizophrenia only, Groups 5-7     will have cannabis use disorder only and Group 8 will be healthy control participants.     Following screening and baseline neuropsychiatric testing, participants will have two tests     days (T1 and T2) that will include task-based functional MRI, including assessment of resting     state connectivity, and measuring a number of other parameters including reward     responsiveness, mood, craving, symptoms and cognition. The assessments at T1 will be     virtually the same for all groups. At T2 Groups 1-3, and Groups 5-7 will be randomly assigned     to one of the following conditions prior to the assessments: receiving 15mg of dronabinol and     smoking a placebo marijuana cigarette, receiving a placebo pill and smoking a real marijuana     cigarette, or receiving a placebo pill and smoking a placebo marijuana cigarette. Group 4 and     Group 8 will receive no drug or placebo at T2. Participants receiving drug will have safety     assessments before the drug is administered, after the drug is administered but before     leaving the research clinic for the day, and again a week later.   "
100979|NCT01964391|"     This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's     satisfaction and safety with subcutaneously administered trastuzumab in participants with     HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg)     administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant     setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs.     The trastuzumab regimen could include mono- and/or combination therapy.   "
100980|NCT01964378|"     Pain is one of the most common symptoms associated with malignant tumor. The purpose of this     trial is to determine whether cebranopadol is as effective in patients with cancer related     pain as morphine sulfate prolonged release.   "
100981|NCT01964365|"     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug     interaction between rosuvastatin and fenofibric acid in healthy adult subjects   "
100982|NCT01964352|"     The objective of this study is to assess the efficacy and safety of 12 weeks once daily     treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler)     compared with tiotropium and placebo in patients with COPD.   "
100983|NCT01964339|"     This is an observational study to characterize the prevalence of Obesity Hypoventilation     Syndrome in patients referred to the sleep lab.   "
100984|NCT01964326|"     The purpose of this actual use study is to simulate the over the counter use of atorvastatin     calcium 10 mg.   "
100985|NCT01964313|"     To describe the role of genetic factors and its relationship and interaction with     environmental factors in the recurrence of cardiac events in Chinese patients with acute     coronary syndrome.   "
100986|NCT01964300|"     This phase II trial studies how well peginterferon alfa-2b works in treating younger patients     with craniopharyngioma that is recurrent or cannot be removed by surgery. Peginterferon     alfa-2b may interfere with the growth of tumor cells and slow the growth of     craniopharyngioma.   "
100987|NCT01964287|"     Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen     is more effective and tolerate than the treatment by Gemcitabine alone in patients with     metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel     improve the objective response rate.      Primary objective of this study is to identify the maximun tolerated dose and the recommended     phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by     folfirinox in metastatic pancreatic adenocarcinoma.   "
100988|NCT01964274|"     In this prospective, multicenter observational study the investigators capture the     perioperative course of peripheral cholinesterase activity. The focus is the perioperative     inflammation causing postoperative delirium. Therefore we measure the activity of     Acetylcholine-Esterase and Butyrylcholine-Esterase in whole blood of adults in the     perioperative context. Early postoperative delirium will be detected by Nu-DESC in the     Recovery Room or the Postanaesthesia-Care-Unit. The course of the peripheral cholinesterase     activity will be compared with the incidence of postoperative delirium and other clinical     dysfunctions.      We follow up the patients for up to five years regarding Delirum, comorbidities and mortality     data.   "
100989|NCT01964261|"     This research study is being conducted to develop a brain controlled medical device, called a     brain-machine interface. The device will provide people with a spinal cord injury some     ability to control an external device such as a computer cursor or robotic limb by using     their thoughts along with sensory feedback.      Development of a brain-machine interface is very difficult and currently only limited     technology exists in this area of neuroscience. Other studies have shown that people with     high spinal cord injury still have intact brain areas capable of planning movements and     grasps, but are not able to execute the movement plans. The device in this study involves     implanting very fine recording electrodes into areas of the brain that are known to create     arm movement plans and provide hand grasping information and sense feeling in the hand and     fingers. These movement and grasp plans would then normally be sent to other regions of the     brain to execute the actual movements. By tying into those pathways and sending the movement     plan signals to a computer instead, the investigators can translate the movement plans into     actual movements by a computer cursor or robotic limb.      A key part of this study is to electrically stimulate the brain by introducing a small amount     of electrical current into the electrodes in the sensory area of the brain. This will result     in the sensation of touch in the hand and/or fingers. This stimulation to the brain will     occur when the robotic limb touches the object, thereby allowing the brain to feel what the     robotic arm is touching.      The device being used in this study is called the Neuroport Array and is surgically implanted     in the brain. This device and the implantation procedure are experimental which means that it     has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists     of a small grid of electrodes that will be implanted in brain tissue and a small cable that     runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed     to be attached to the skull and protrude through the scalp to allow for connection with the     computer equipment. The top portion of the pedestal has a protective cover that will be in     place when the pedestal is not in use. The top of this pedestal and its protective cover will     be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted     in this study so three of these protective covers will be visible outside of the head. It     will be possible to cover these exposed portions of the device with a hat or scarf.      The investigators hope to learn how safe and effective the Neuroport array plus stimulation     is in controlling computer generated images and real world objects, such as a robotic arm,     using imagined movements of the arms and hands.   "
100990|NCT01964248|"     The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne     versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a     numeric Pain Intensity for all patients included.   "
101323|NCT01959880|"     The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's     Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation,     primary reconstruction, or revision. Safety information on the rate of capsular contracture,     rupture and infection will be collected and used to determine device safety.   "
100991|NCT01964235|"     This study is establish whether INC280 is safe and has beneficial effects in patients with     advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose     disease progressed while on, or after, treatment with sorafenib or who are intolerant to     sorafenib.      Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best     supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study     treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280     treatment upon documented further disease progression (RECIST 1.1) per investigator's     discretion after unblinding.      Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden     (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).   "
100992|NCT01964222|"     This study will update an existing health literacy intervention (decision aid) for informed     consent procedures and then conduct a randomized experiment implementing the health literacy     intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care.     Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to     usual care will increase knowledge about cancer clinical trials. Secondary outcomes include     patients' ability to communicate with health care providers about trials, willingness to     participate in trials, and enrollment rates for minority participants.   "
100993|NCT01964209|"     This proposal is to evaluate the reliability and validity of the Vanderbilt ADHD screening     tool for use with adolescents and young adults aged 13-21 years. The Vanderbilt is a     previously developed, freely available set of parent- and teacher-report questionnaires     designed to identify ADHD and related disorders in children. The Vanderbilt measures have     been chosen for inclusion in the new computerized Integrated Clinical Information Sharing     System (ICISS) being rolled out in five Boston Children's Hospital (BCH)     departments/divisions (Adolescent/Young Adult Practice, Children's Hospital Primary Care     Center, Developmental Medicine Center, Department of Neurology, Department of Psychiatry).     The Vanderbilt was developed and validated for use among children up to age 12 years     (Wolraich et al., 2003; Wolraich et al., 2013; Bard et al., 2013), and little is known about     its appropriateness for use among older youth. In addition, there is no self-report version     of the Vanderbilt that can be administered directly to adolescents and young adults (ages     13-21 years), for whom parents and teachers are often less knowledgeable reporters. To     address these shortcomings, a multidisciplinary team of BCH adolescent health clinicians and     researchers modified the parent and teacher Vanderbilt questionnaires to make them     age-appropriate for adolescents and young adults and created a complementary self-report     version for adolescents and young adults. The goal of the current study is to 1) assess the     feasibility and acceptability of online administration through the ICISS system of the new     parent, teacher, and youth self-report Vanderbilt measures among adolescent and young adult     BCH patients aged 13-21 years; 2) test their reliability in terms of internal consistency     reliability, temporal stability of responses over a one-month test-retest, and inter-rater     agreement across all informants (parents, teachers, and youths); and 3) test their validity     by evaluating their convergence with a similar set of ADHD screening tools, the Conners     scales, already validated for use with adolescents and young adults.   "
100994|NCT01964196|"     This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of     anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied     intermittently.   "
100995|NCT01964183|"     To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects     on the pharmacokinetics (PK) of tolterodine and its metabolites.      In addition, the safety of these products will be assessed.   "
100996|NCT01964170|"     To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate     cancer.   "
100997|NCT01964157|"     ROS1 is a receptor tyrosine kinase with constitutive kinase activity. ROS1 was previously     discovered in cell lines where ROS1 fused with other proteins to act as a driver oncogene. In     2007, Rikova et al reported ROS1 fusion as driver mutations in NSCLC cell line (HCC78;     SLC34A2-ROS1) and NSCLC patient (CD74-ROS1). Li et al also found about 1% of samples     harboring CD74-ROS1 fusion in 202 resected lung adenocarcinomas from never smokers. The     incidence was as high as 10% in East Asian population. Currently there are now at least 13     ROS1 fusion variants involving 8 fusion partners (CD74-, SLC34A2-, FIG-, TPM3-, SDC4-,     LRIG3-, ERZ-, KDERL2-) identified in ROS1 positive NSCLC. LDK378 is an orally highly     selective and potent ALK kinase inhibitor. In preclinical studies, LDK378 has much lower IC50     values than crizotinib in cell lines engineered to express ROS1 rearrangement (0.15 nM versus     3 nM) and is approximately 20-fold more potent. LDK378 is a potent inhibitor of tumor growth     in rodent models of both ALCL and NSCLC. We suggest a phase II trial of LDK378 in advanced     non-small cell lung cancer patients with ROS1 rearrangement. The aim of current trial is to     evaluate the antitumor efficacy and safety profile of LDK378 and to identify biomarker to     predict the tumor response to LDK378.   "
100998|NCT01964144|"     There has been no effective treatment for advanced thyroid cancer that is not amenable to     surgery and that does not concentrate iodine. Response rates with chemotherapy have been so     low that best supportive care has been the standard of care for most patients. In recent     phase I and phase II clinical studies, dovitinib has shown activity as a single agent in     solid tumors. Therefore, we will conduct a phase II, single-arm trial to determine the     efficacy of dovitinib in radioactive iodine-refractory recurrent or metastatic thyroid     cancer.   "
100999|NCT01964131|"     The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to     a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4.      To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of     percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.      To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.      To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.   "
101000|NCT01964118|"     The purpose of Intermittent Fasting study is to investigate whether intermittent fasting     could decrease the chronic inflammation levels in overweight/obese people.   "
101001|NCT01964105|"     The purpose of this trial is to evaluate the impact of incorporating three-dimensional     (3D)imaging during preoperative consultation on patient reported outcomes in primary breast     augmentation surgery. 3D imaging is an innovative technology that allows the surgeon to share     with images how one could look after one's procedure. The patient's assessment will be     collected using the Breast Q, an objective questionnaire that captures patient satisfaction     with breast augmentation.   "
101002|NCT01964092|"     Roughly one third of disability pensions issued in Norway are classified as mental and     behavioral disorders. The proposed study aims to evaluate the effect of an innovative     intervention for returning people with moderate to severe mental health disorders to work:     Individual Placement and Support (IPS).   "
101324|NCT01959867|"     This is a prospective clinical study comparing two-stage breast reconstruction following     mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in     patients with pre-mastectomy radiation therapy.   "
101003|NCT01964079|"     Blood pressure (BP) is believed to be a major determinant of vascular disease, and BP     lowering is the most important goal in hypertension treatment. Thus, clinical guidelines for     hypertension are mainly focused on lowering mean BP. However, despite an increasing incidence     of stroke with age, the association between systolic BP (SBP) and the risk of stroke     decreases with age. This disparity highlights a gap in the link between BP and     vascular-related diseases (i.e., stroke). In clinical practice, visit-to-visit fluctuations     in BP have been largely ignored and are thought to be an unreliable finding, even though this     phenomenon is frequently observed. Rothwell et al. demonstrated that the visit-to-visit     variability in SBP was a more powerful independent predictor of stroke than mean SBP, and     that an increased residual variability in SBP in treated hypertensive patients was also a     strong predictor of stroke and coronary events.      Recently updated (2011) hypertension guidelines from the National Institute for Health and     Clinical Excellence (NICE) recommend an angiotensin converting enzyme inhibitor (ACEi) [or     angiotensin II receptor blocker (ARB)] and calcium-channel blocker (CCB) as a first line     drug. Although the significance of BP variability (BPV) has been illustrated, the main focus     of the current guidelines is to reduce systolic and diastolic BP, not BPV.      In the X-CELLENT study, a CCB (amlodipine) and thiazide-like diuretic drug (indapamide     sustained-release) led to a significant reduction in BPV, compared to an ARB (candesartan).     In addition, the CCB showed the most effective reduction in systolic BPV among the     antihypertensive drug class in a meta-analysis. However, there are no direct comparison     studies of a CCB and ARB on BPV. Thus, we aim to compare the systolic BPV effects of a CCB     versus an ARB in essential hypertensive patients. The primary hypothesis is that an ARB is     not inferior to a CCB in the reduction of the systolic BPV standard deviation (SD) in     essential hypertensive patients.   "
101004|NCT01964066|"     For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has     been the most frequent adverse effect of endoscopic transpapillary interventions. We sought     to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP     pancreatitis.      Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491     patients was conducted. The first group of patients (N=247) received thoracic epidural     analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a     narcotic analgesic. To detect statistically significant differences between research groups     adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.   "
101005|NCT01964053|"     Non-adherence to self-management behaviors is prevalent and accounts for hospital     readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to     activate and engage HF patients in managing their own care is uncertain. Yet post-acute care     service that is vital to improve HF patients' self-management adherence and HF outcomes is     suboptimal in rural hospitals (primarily critical access hospitals). The investigators     central hypothesis is that patients with higher activation level will have significantly     better self-management adherence. This study will test whether Patient AcTivated Care at Home     (PATCH) will improve self-management adherence and health outcome (reduced hospital     readmissions), as well as the feasibility to translate the research findings to a home based     post-acute care service in rural communities.   "
101006|NCT01964040|"     The duration of sensory block after single dose of long acting local anesthetics is not     sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as     clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine     is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our     knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously     reported for femoral nerve block.   "
101007|NCT01964027|"     This study is to determine the response rate and safety profile of irinotecan plus epirubicin     as the second-line chemotherapy for advanced gastric cancer and fully evaluate the     feasibility and effectiveness of the regime.   "
101008|NCT01964014|"     The objective of this study is to assess the efficacy and safety and Immunosuppressant     Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients     who had kidney transplantations earlier.   "
101009|NCT01964001|"     Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second     cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as     antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of this     study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the     indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers     in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study. The     investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are identified     by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50 mg/d), coenzyme     Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups. Intervention is going     to administration for three months. The concentrations of vitamin B-6, coenzyme Q10,     oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin A     and E), and inflammatory markers are going to be analyzed. The results would provide more     information nutrients for clinical physicians and dietitians for considering suggesting     patients with HCC using vitamin B-6 or coenzyme Q10 supplementation to improve their clinical     outcomes.   "
101010|NCT01963988|"     On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome     (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer.      But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in     ulcer type BPS patients.      We assume TUR have a more therapeutic effect than TUC.   "
101011|NCT01963962|"     The purpose of this study is to see how often women who come to a family planning clinic for     emergency contraception, the morning after pill, are willing to use either the copper IUD or     the levonorgestrel IUD. The investigators will also see if pregnancies occur in those     choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.   "
101012|NCT01963949|"     To collect tumor tissue from patients with liver masses suspicious for primary liver cancer.     The research biopsy will be used to identify biomarkers in future studies.   "
101053|NCT01963416|"     Acute, randomized, placebo controlled, double blind, postprandial crossover study in male     subjects. 4 intervention arms consisting of control, orange juice, whole orange, and     processed whole orange to determine the effect of the interventions on the primary measure of     flow mediated dilatation (FMD) and additional biomarkers of health. The study will also     identify and quantify the main micronutrients and phytochemicals in each of the products and     will identify and quantify the main micronutrients and phytochemicals and their metabolites     in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited     to participate in an additional arm of the main study which is summarised below.   "
110580|NCT01838590|"     This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus     ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.   "
101013|NCT01963936|"     Laryngeal mask airways (LMA) that fit over the laryngeal inlet have been shown to be     effective for ventilating newborns at birth. The LMA may be considered as an alternative to     FM for positive pressure ventilation (PPV) among newborns weighing >2000 g or delivered >34     weeks' gestation.      A recent, quasi-experimental study provided the feasibility, efficacy and safety of using the     LMA in neonatal resuscitation.      However, studies of LMA use for providing PPV during neonatal resuscitation are still     limited. There are no published clinical randomized trials evaluating the LMA compared with     the FM for neonatal resuscitation.      Hypothesis: Our hypothesis is based on the assumption that ventilating newborns needing PPV     with a LMA will be more effective than ventilating with a FM by decreasing the proportion of     resuscitated newborns needing ETT.      Objective: To compare the effectiveness of LMA and FM ventilation in newborns needing PPV at     birth.      Design / Methods: An open, prospective, randomized, single center, clinical trial.      Intervention: PPV will be performed with a LMA (intervention group) or with a FM (control     group) in all infant newborns weighing >2000 g or delivered >34 weeks gestation.      Primary outcome variable: Proportion of newborns needing endotracheal intubation.      Secondary outcome measures: Apgar score at 5 minutes, heart rate at 60, 90 seconds and 5 and     10 minutes, time to first breath, duration of PPV, for proportion of infants needing chest     compressions, drugs and death within 1 week and/or presence of HIE, grade II or III,     according to a modification of Sarnat and Sarnat.2,10 According to this classification, HIE     grade I (mild) includes irritability, hyperalertness, mild hypotonia, and poor sucking; grade     II (moderate) includes lethargy, seizures, marked abnormalities of tone, and requirement of     tube feeding; and grade III (severe) includes coma, prolonged seizures, severe hypotonia, and     failure to maintain spontaneous respiration.      The following data were collected during resuscitation: (1) Apgar score at 1 min and 5 min     after birth; (2) LMA insertion time, the rate of successful insertion at the first attempt,     and the number of attempts required to insert the LMA successfully; (3) duration of     resuscitation: response time (the time period from starting LMA resuscitation to achieving an     effective response), ventilation time; (4) adverse effects during resuscitation.   "
101014|NCT01963923|"     The purpose of this study is to establish the effectiveness of a preoperative pulmonary     rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted     thoracic surgery in order to improve exercise tolerance and quality of life. The     investigators hypothesized that a pulmonary rehabilitation program including both endurance     and strength training may improve exercise tolerance and quality of life measured with a     submaximal exercise test and a quality of life questionnaire respectively.   "
101015|NCT01963910|"     Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon     application. The investigators wish to determine whether mannitol blocks the effect of     capsaicin application. As both cream bases are identical and mannitol addition is the only     difference between the creams, if the mannitol cream is more effective in blocking the effect     of capsaicin on the TRPV1 (transient receptor potential vanilloid 1) receptor, the     investigators will have established that mannitol down-regulates or blocks the TRPV1     (transient receptor potential vanilloid 1) receptor.   "
101016|NCT01963897|"     The study will give a consent based epidemiological overview of Norwegian patients with     Duchenne muscular dystrophy younger than 18 years of age. Genotype of the population will be     described. Longitudinal development of growth, bone health, and , when applicable, puberty     over a two year period will be studied. Questionnaires regarding quality of life will also be     an important part of the study.   "
101017|NCT01963884|"     In patients that are going to be subjected to a tooth extraction in the anterior maxillary     (from canine to canine) does the position of the intact alveolar socket related to maxillary     basal bone interferes with the rate of resorption and remodeling process of the alveolar     ridge ?   "
101018|NCT01963871|"     The purpose of this study is to determine if yoga is an effective intervention in treating     individuals with chronic low back pain (LBP).   "
101019|NCT01963858|"     Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is     the most common reason for low acceptance of colonoscopy. Several methods have been used to     minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness     colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to     participate in administration of medication. Although a potential benefit from some of these     methods has been suggested, no clear recommendations have been made so far. We hypothesized     functional relaxation reduces discomfort during colonoscopy.   "
101020|NCT01963845|"     Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from     simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver     disease that can lead to cirrhosis and liver-related mortality in persons who drink little or     no alcohol. NAFLD is defined as the presence of hepatic steatosis with no evidence of     hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the     presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or     without fibrosis. NASH is benign in many affected individuals but can cause progressive liver     injury and, indeed, may be the major cause of cryptogenic cirrhosis1. Currently, there is no     FDA approved treatment for NAFLD. Weight loss and exercise are the recommended but often     difficult maintain these lifestyle changes in the long term and therefore therapeutic agents     have been investigated. In this study, we propose to treat 50 patients with NAFLD and     diabetes with either sitagliptin or placebo for 24 weeks. After an initial evaluation for     insulin sensitivity and MRI liver fat distribution, patients will receive either 100 mg/day     of sitagliptin or placebo. Patients will be monitored at regular intervals for symptoms of     liver disease, side effects of sitagliptin and serum biochemical and metabolic indices. At     the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and an     optional liver biopsy. Pre and post treatment MRI-derived liver fat content and insulin     sensitivity will be compared. The primary end point of successful therapy will be improvement     in hepatic steatosis measured by MRI. Secondary end points will be improvement in insulin     sensitivity and liver biochemistry.   "
101021|NCT01963832|"     Stroke patients who have little or no voluntary movement in the hand on the more affected     side of their body more than one year after stroke have few treatment options. This project     proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for     patients with such severe impairment in conjunction with an agent, fluoxetine, which has been     shown in some studies to enhance brain neuroplasticity in response to training.     Constraint-Induced Movement therapy, which is abbreviated CIMT, is a form of physical     rehabilitation based on basic research in neuroscience and behavioral science. If the project     is successful, an efficacious, evidence-based therapy will become available to stroke     patients for what is now a largely untreated condition   "
101022|NCT01963819|"     The aim of this study is to evaluate the potential benefits in implantation, clinical     pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment.     Including a follow up on possible pregnancy complications and data on children at birth.      Further it is planned to aspirate secretions from the uterus and take blood samples during     the treatment, which presumably can provide information about the mechanisms underlying the     possible effect of the treatment.   "
101023|NCT01963806|"     BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the     reach of psychotherapeutic interventions by moving selected parts of the therapy into the     real-life situations causing distress. This randomised controlled trial will investigate the     effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help     program for anxiety, supplemented with a tailored smartphone application. The effect of added     therapist support will also be studied.      METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder     and/or panic disorder will be evenly randomised to one of three treatment arms: (1)     smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without     therapist support; or (3) an active waiting list control group with delayed treatment. After     the 10 week treatment period, the control group (3) will receive the same treatment as group     (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating     scale. Secondary measures include other anxiety, depression and quality of life measures. In     addition to pre- and post-treatment measurements, the study includes two mid-treatment and     two follow-up assessments (12 and 24 months).      HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be     superior to the unguided form in reducing anxiety levels, and that both delivery modes will     be superior to an active waiting-list control group.   "
101024|NCT01963793|"     Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically     Applied Aprepitant in Patients With Prurigo   "
101025|NCT01963780|"     To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess     donor lungs that may not meet current standard donor lung acceptance criteria for     transplantation.   "
101026|NCT01963767|"     Interventions to improve the cognitive health of older adults are of critical importance. In     the current protocol, ithe investigators conducted a short-term (two months) randomized     clinical trial to examine the influence of the nutraceutical NT-020 on the cognitive     performance of older adults. Participants were tested with a battery of cognitive tasks at     baseline and two months after being randomized to the interventional drug or placebo.   "
101027|NCT01963754|"     In patients that are going to receive a dental implant in the posterior mandible (distal from     canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine     compared to the loco-regional one, produces the same analgesia during surgery ?   "
101028|NCT01963741|"     Leukotrienes play critical roles in the inflammatory process in allergic rhinitis and     bronchial asthma, therefore, anti-leukotriene therapy is part of treatment for asthma.     However, not all allergic rhinitis accompanied with or without asthma treated with     anti-leukotriene were effective. So it is critical to develop a method to identify the     response subgroup. In this study, it is assumed that nasal physiological responsiveness to     leukotriene nasal provocation test (NPT) is able to gain evidence on the effect of     leukotriene on the development of allergic rhinitis and asthma, and is helpful to the use of     anti-leukotriene agent. The purpose of the study is to establish the methodology and     diagnostic value of leukotriene D4 (LTD4) nasal provocation.   "
101029|NCT01963728|"     To determine if the use of insulin isophane results in improved control of blood sugars     compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart     transplantation (NODAT).   "
101030|NCT01963715|"     This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult     patients with advanced EGFR-positive tumors.   "
101031|NCT01963702|"     Platinum, fluorouracil and taxane based regimen are all acceptable in the first line     treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used     in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather     part of patients can't get benefit from the treatment. It is urgent to find out the     predictive factors of these regimens in order to get a higher response and better survival     outcome.   "
101032|NCT01963689|"     The aim of this study was to determine whether the use of Ylang Ylang essential oil through     dermal application or inhalation alters the perception of anxiety and self-esteem and     physiological parameters such us blood pressure and temperature.   "
101033|NCT01963676|"     Investigating the effect of non-invasive transcranial current stimulation on auditory     hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in     schizophrenia, so selective targeting of this abnormal activity could serve as a treatment     for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as     auditory hallucinations.   "
101034|NCT01963663|"     Patients with type 2 diabetes are at an increased risk for developing atherosclerosis,     largely due to the underlying insulin resistance and chronic low grade inflammation.     Cardiovascular events could be prevented with proper interventions targeted at ameliorating     the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and     chronic inflammatory states has been implicated to have a putative role in both pathways.     Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that     anti-diabetes medications are able to modify coronary artery disease risk via direct and     indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore     launched to examine the comparative effects of metformin and pioglitazone, two commonly     prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve,     newly-diagnosed type 2 diabetes patients.   "
101035|NCT01963650|"     The purpose of this study is evaluate the natural course of disease progression related to     gross motor function in children with metachromatic leukodystrophy (MLD).   "
101047|NCT01963494|"     Regular physical activity is one prominent health-protective behaviour which might increase     with the help of self-regulatory strategies such as action planning.      The aim of this randomised controlled trial is to examine changes in daily moderate physical     activity in couples following (a) a dyadic planning intervention, (b) an individual planning     intervention or (c) a no-planning control condition. Changes in daily physical activity will     be examined over a period of one year.      It is assumed that target persons from couples receiving a dyadic planning intervention will     show greater increases in daily physical activity than target persons from couples receiving     an individual planning intervention. For couples receiving a dyadic planning intervention or     an individual planning intervention, it is hypothesized that target persons will show higher     increases in daily physical activity than target persons from couples participating in the     no-planning control condition.   "
101036|NCT01963637|"     The Gastric bypass (GBP) is actually one of the most performed bariatric procedures     worldwide. Short term results report 67% of mean Excess Weight Loss (EWL) at 2 years, and 58%     EWL at 5 years. Sleeve gastrectomy (SG) which is a restrictive procedure has gained in     popularity because of its technical simplicity and its efficiency (60% EWL at 1 year and 48%     over 4 years). However, failures are observed because of insufficient weight loss or early     weight regain. Several hypotheses have been proposed to explain these failures, such as the     size of the gastric pouch that could be correlated to weight evolution.      Purpose of the study Taking the hypothesis that a progressive dilatation of the gastric pouch     is one of the main factors of weight loss failure after GBP or SG due to the loss of its     restrictive function, the aim of our study is to measure these gastric volumes using gastric     tomodensitometry with gas, a new reliable,precise and 3 dimension radiological technique. The     investigators will try to identify a positive correlation between gastric dilatation and     weight regain.      Methods This is a 2 year interventional, prospective, monocentric study with longitudinal     follow-up. Forty-five obese patients (BMI>40kg/m²) eligible for primary GBP (n=25) or SG     (n=20) will be included. Gastric volumes will be measured by gastric tomodensitometry with     gas at 3 and 12 month after surgery. In the GBP group, the investigators will measure the     gastric pouch volume, the candy cane Roux limb volume, the neostomach volume (= gastric     pouch+candy cane Roux limb) and the gastro-jejunal anastomosis diameter. In the SG group, the     investigators will measure the volume of the gastric tube, of the non resectedantrum, of the     whole residual stomach and the gastric tube diameter at the middle of the small curvature.     Volume variations between 3 and 12 months will be compared to the EWL and to clinical and     metabolic data (HbA1c, Insulinemia, HOMA index, liver steatosis). A 30% dilatation of the     neostomach at 12 months will be considered as significant. Reinhold's criteria will be used     to define surgical failure: EWL<50% at 12 months. Weight regain will be considered as     significant if the weight reached at 12 months is higher than the minimum weight obtained.     Gastric volume variation, EWL and BMI evolution between the 3rd and the 12th month will be     analysed in the whole population and in each group (GBP and SG) with a Wilcoxon test.      Expected benefits If the investigators valid the hypothesis that the dilatation of the     neostomach is an essential factor in weight regain after GBP and SG, the benefit for the     patient will be dual: 1/ validate the prognostic value of gastric volumetry by gastric     tomodensitometry with gas in order to explain weight regain, and in order to use it as a     standard. 2/ the identification of specific risk factors related to the surgical procedure     could result in surgical technique improvements as well as a better adaptation of revisional     procedures, in order to improve treatment of recurrent obesity.   "
101037|NCT01963624|"     The investigators hypothesis is that the combined use of elastography and color doppler     ultrasonography can increase positive-predictive value of breast screening with ultrasound.   "
101038|NCT01963611|"     This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4     doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing     Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for     minimum treatment duration of 40 weeks.   "
101039|NCT01963598|"     This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the     safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients     with sarcopenia.   "
101040|NCT01963585|"     Background:      Bronchial hyper responsiveness (BHR) assessed by methacholine challenge test (MCT) may aid in     the diagnosis of asthma, while negative MCT can help to exclude the diagnosis. Laboratory     measures that predict the results of MCT are expected to reduce the number of procedures. The     possible capacity of High sensitive C-reactive protein (hs-CRP), a marker of systemic     inflammation, to predict negative or positive MCT in children has not been evaluated.      Aim: to evaluate the capacity of hs-CRP to predict positive or negative MCT in school aged     children and to compare it with markers of airway inflammation: Fractional exhaled Nitric     Oxide (FeNO) and markers of allergic sensitization (IgE and peripheral blood eosinophils).      Design: Prospective study evaluating these parameters in patients with positive and negative     MCT.      Participant selection: The study population included subjects (age range 6 to 18 years)     referred for Methacholine Challenge Test (MCT)      Sample size: 130 participants in the two groups. Intervention: Each subject will undergo     evaluation including a respiratory questionnaire, methacholine challenge test with     determination of PC20(the provocative concentration that reduced FEV1 by 20% from baseline),     exhaled nitric oxide (eNO). Venous blood will be analyzed for complete blood count +     eosinophils, IGE levels, hs-CRP. All measurements will be evaluated in a single 3 hour visit,     with no follow up study visits.      Primary end point: hs-CRP levels as add on tool to predict negative or positive MCT in     children Secondary outcome parameters: All other parameters are the secondary end points.   "
101041|NCT01963572|"     Background and Purposes: Cancer is the leading cause of our mortality. It threatens people's     life and quality of life (QOL). Although the incidence of cancer is still rising, with the     promotion of cancer screening and progression of medical technology, its survival rate is     improving. However, the sequels from cancer or its treatment and the side effects impact the     patients along with their lives. Breast cancer is the most incident cancer in women with high     survival rate, continuing care after the diagnosis and treatment is much more needed. This     study is using breast cancer as an example to establish a continuing service model. This     study aims (1) to establish a tailored, continuing care model which emphasizes on breast     cancer patients' function. (2) To investigate the effectiveness of the new care model     comparing with the control. (3) To find a cutting point of bioelectrical impedance to     identify late development of lymphedema.      Methods: This is a randomized-controlled trial expanding for 3 years. Women being newly     diagnosed with breast cancer and first OPD visit after operation at National Taiwan     University Hospital will be invited to join the surveillance and care system. Exclusion     criteria are: younger than 20 years old, stage IV, recurrent or both sides involved, with     other cancer diagnosis, functional impairments from previous injury or operation on the     affected upper extremity and other physical or mental problem to influence the test or     filling the questionnaire. It is estimated there will be 100 subjects participate this study     every year. After the initial evaluation, they will be randomly allocated to surveillance     group (SG) or general care group (CG). Totally, in this three-year study, there will be 200     subjects (100/group), follow-up for 0.5 to 2 years. SG will have health education brochure     and free class from the first visit post-operatively but CG will only have the brochure.     Moreover, SG will be screened every time when they visit the clinics. If there is any early     sign of impairment, professional advice and counseling will be given additionally. In these     visits, if CG raises any health-related question, they can be answered. Detailed physical     examination to identify their impairments and QOL are at 3, 6, 12, 18, 24 months after     operation for both groups. Patients' characteristics, functional status, QOL will be     presented by descriptive statistics. T-test/Mann-Whitney U test will be used to compare the     differences between patients in two groups. Survival analysis and log-rank test will be used     to show the prevalence of various functional impairments and test their difference. ROC curve     will be used to find the cutting point for prediction of lymphedema.      Expected Results: It is expected (1) to set up the education program and brochure for breast     cancer patients. (2) to establish a continuing surveillance and care model for breast cancer     patients and extending to all cancers. (3) Women in the new care model will have less     impairment and higher QOL comparing with women at the same post-operative stage. (4) To find     out the prevalence of functional impairments from the data of control group. (5) A cutting     point of bioelectrical impedance to identify late development of lymphedema will be found.     (6) To train the team members of cancer care and research.   "
101042|NCT01963559|"     15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of     amputation and mortality two times greater than that of a diabetic population without DF.     Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up     involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced     Vasodilation (PIV) first observed in healthy subjects after local application of a gradual     pressure on the skin leading to cutaneous vasodilation at the application of pressure. This     gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF,     which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic     subjects. The main objective of this study is to show that PIV, a functional examination of     the cutaneous microcirculation we developed, is altered in the presence of DF, taking into     account the influence of age and neuropathy.   "
101043|NCT01963546|"     General anesthesia can be considered as a combination of hypnosis, antinociception and     immobility. Explore the effect of three kinds of anesthesia,that is the total intravenous     anesthesia, inhalation anesthesia and inhalation and intravenous anesthesia on stress     reactions generated by patients with diabetes conducted gastric - bypass surgery , and choose     a best way from three kinds of anesthesia to control stress reaction of diabetics. After     selecting the appropriate anesthesia method, assess the effect of dexmedetomidine on     controlling stress response from diabetics undergoing laparoscopic gastric-bypass surgical.   "
101044|NCT01963533|"     The investigators hypothesize that the age-adjusted telomere length in lung cancer patients     before chemotherapy may be correlated to comorbidity status and predict outcome. The change     of telomere length shortening after chemotherapy may relate to treatment side effect and     treatment response.   "
101045|NCT01963520|"     Data from large prospective cohort studies of prosthetic joint infections are lacking.      Aim of this study: analyzing prospectively the incidence of reinfection in patients with     prosthetic hip infections who underwent surgery and received antibiotic therapy.      Hypothesis: to confirm in a large group that the incidence of reinfection after excision     -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after     exchange arthroplasty (one or two stage exchange).   "
101046|NCT01963507|"     The study aimed to evaluate the chronic effects of resistance training on blood pressure and     biochemical exams in hypertensive elderlies and the influence of the polymorphism of the     angiotensin converting enzyme in these response.   "
101048|NCT01963481|"     This phase II trial studies how well exemestane and cyclophosphamide work in treating     patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and     human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.   "
101054|NCT01963403|"     This double-blinded, placebo-controlled, randomized trial will compare the effects of the use     of a combined oral contraceptive pill to a placebo pill for women who are experiencing     irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.      The hypothesis of the study is:        -  Use of combined oral contraceptive will significantly improve bleeding patterns for          users of ETG implant        -  Continuation rate of ETG implant users will be increased by use of combined oral          contraceptive in women desiring ETG implant removal because of the undesirable bleeding        -  Adverse events will be uncommon and acceptable to women who use a combined oral          contraceptive with the ETG implant   "
101055|NCT01963390|"     One promising but understudied area in the field of testosterone (T) therapy is its effect on     metabolism and the development of type II diabetes. Metabolomics is a powerful research tool     that can detect very early signs of metabolic derangement that may lead to metabolic disease.     In this observational study, investigators aim to apply metabolomics in order to better     understand how T therapy influences metabolism. In a clinical population of outpatient men     with T deficiency investigators will perform comprehensive clinical evaluations and also     obtain blood for metabolomics. This will be done once prior to T therapy and again after 4-6     months of T therapy. Investigators hypothesize that they can detect metabolic derangements in     men with T deficiency and that these derangements will improve with T therapy.   "
101056|NCT01963377|"     Feasibility of using an extra bronchoscopic channel for supplementation of oxygen will be     studied by comparing O2-supplementation by nasal cannulae versus O2-supplementation through     aspiration channel of the bronchoscope.   "
101057|NCT01963364|"     Some carbohydrates (complex sugars) which are found in grains, fruit and vegetables, cannot     be digested by humans. When eaten they pass through the small bowel to the large bowel, or     colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use     them as an energy source. This releases energy that humans can absorb, and may have other     effects on health as well. The process also releases gases such as hydrogen and methane into     the colon, which will eventually be released as flatulence.      There is some evidence in animals, and humans, that changing the carbohydrate content of the     diet may increase the numbers of bacteria in the colon that can use this energy source.     Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect     transit, the speed at which food and stool moves through the stomach and bowels. This     undergraduate project will use techniques in Magnetic Resonance Imaging developed in     Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed     of transit through the bowel and gas production in the colon, and whether there is any     evidence of a change in the level of signalling chemicals that may affect bowel function.   "
101058|NCT01963351|"     This observational trial is designed to assess the safety profile and tolerability of     bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent     non-squamous NSCLC.   "
101059|NCT01963338|"     The aim of this study was to assess the acceptability and usability of a newly developed     intradermal device in healthy adults   "
101060|NCT01963325|"     This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as     second-line treatment for cholangiocarcinoma.   "
101061|NCT01963312|"     The purpose of this study is to determine whether the transarterial supraselective     embolization (TSE) is a technique as effective as transurethral resection of the prostate     (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic     hyperplasia (BPH).   "
101062|NCT01963299|"     This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the     first will receive ropivacaine alone and the second will receive the association     ropivacaine/clonidine.      The aim of the study is to prove that the association of Clonidine with Ropivacaine is more     effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.      The principal interest of this association of drugs is that it procures faster and longer     anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides     greater comfort to the patient during and after the intervention.   "
101063|NCT01963286|"     The purpose of this clinical investigation is the continued assessment of the decision     accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of     subjects with primary and secondary prevention of sudden cardiac death.   "
101064|NCT01963273|"     The investigators supposed that the complete video assisted ablation of pilonidal sinus     (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new     minimally invasive treatment allows the identification of the sinus cavity with its lateral     tracks, the destruction and the removal of all infected tissue and the removing of any hair.   "
101065|NCT01963260|"     The primary objectives of this study are to assess the safety and tolerability of single     rising doses of MK-8723 in healthy adult participants and adult participants with chronic     immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in     participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet     response rate to MK-8723 in adult patients with chronic ITP is >50%.   "
101066|NCT01963247|"     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which     are temporal reflections of the neural mass electrical activity of cells in specific regions     of the brain that occur in response to stimuli, may offer such a method, as they provide both     a noninvasive and portable measure of brain function. The ERPs provide excellent temporal     information, but spatial resolution for ERPs has traditionally been limited. However, by     using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is     improved significantly. The paradigm for the current study will combine neurophysiological     knowledge with mathematical signal processing and pattern recognition methods (BNA™) to     temporally and spatially map brain function, connectivity and synchronization.      The proposed study will provide additional evidence for the utility and contribution of the     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain     functional connectivity associated with concussion) in concussion management.      The BNA test is basically divided to 3 phases - first EEG data is collected from subjects     using an EEG system while the subject is performing a cognitive task in front of a computer.     The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the     BNA™ test is generated.   "
101068|NCT01963221|"     The purpose of this study is to determine the relationship between thoracic aortic     inflammation and arterial stiffness in elderly patients.      Vascular-aging is accompanied by a gradual remodeling affecting both cardiac and arterial     walls. Arterial hypertension, an established cardiovascular risk factor, has been suggested     to exert pro-inflammatory actions threw several biological mediators enhancing arterial     stiffness. Both effects of aging and hypertension are associated with higher levels of     arterial stiffness, but their respective role is not well established in the pathophysiology     of arterial stiffening.      Few data are available neither on the real anatomic aortic impact of aging and hypertension     on aortic compliance and ventricular function and its relationship to arterial stiffness     assessed by carotid-femoral pulse wave velocity, nor on the reliability of cine phase     contrast magnetic resonance imaging arterial stiffness measurements.      Recent studies using positron emission tomography imaging (PET) with 18 F fluorodeoxyglucose     (FDG) has been advocated as a means of measuring arterial wall inflammation in various     population referred for oncology staging. FDG uptake is correlated with the number of     cardiovascular risk factors and even the risk of future cardiovascular events. This method,     combined with X-ray computed tomography (CT), has also demonstrated that aortic     calcifications quantified by CT and local signs of inflammation detected by FDG uptake     contribute to arterial stiffness. A strong relationship between large vessels stiffening     assessed by carotid-femoral pulse wave velocity measurement, aortic calcifications quantified     by CT and inflammation evaluated by FDG uptake has been demonstrated.      Therefore, in the current study, we use FDG PET associated to CT to characterize aortic     inflammation and aortic calcifications coupled to pulse wave velocity measurement and cardiac     function in elderly individuals.      In fact, if vascular aging promoting a local inflammatory process is a risk factor for     cardiovascular disease, then vascular changes assessed by non-invasive vascular imaging     (MRI,FDG PET) could represent a potential target for treatment and prevention Thirty     individuals ≥ 65 years of age were examined, 15 hypertensive subjects and 15 controls. Pulse     wave velocity, a surrogate for aortic stiffness, was measured both by cine phase contrast     magnetic resonance imaging and applanation tonometry. Brachial pulse pressure, carotid     calculated pulse pressure and pulse pressure amplification (brachial to carotid ratio),     predictors of cardiovascular mortality were also quantified. Thoracic aorta local     inflammation and calcification were measured by 18 F-fluorodeoxyglucose positron emission     tomography/computed tomography imaging. Moreover, biomarkers of low grade inflammation     (high-sensitivity C-reactive protein, interleukin 6 were also determined).   "
101069|NCT01963208|"     The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone -     on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic     medications (AEDs).   "
101070|NCT01963195|"     The purpose of this study is to evaluate the efficacy and safety of dose escalation of     Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of     Icotinib, Iressa and Tarceva.   "
101071|NCT01963182|"     This prospective, non randomized multicenter phase II study, will determine the feasibility     of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with     metastatic colorectal cancer treated with FOLFIRI.   "
101072|NCT01963169|"     Bone health is a significant public health issue in the United States. An estimated 10     million Americans age 50 and older are living with osteoporosis, and approximately 50% of     women and 25% of men over age 50 will experience an osteoporosis-related fracture in their     remaining lifetime. Recent research advancements have produced effective measures to improve     and maintain bone health, including exercise, diet, screening tests, pharmacotherapies, and     fall prevention strategies. These findings, however, have not been fully incorporated into     the daily lives of adults, and many are unaware of the magnitude of bone-health problems.     Thus, greater efforts must be made to effectively disseminate evidence-based research     findings to improve bone health behaviors of the public. The Internet, with its increasing     popularity, can be an effective tool in this endeavor. Despite a great deal of available     online health resources, there has been a lack of research investigating effective methods to     package and deliver these resources to yield positive public health outcomes. Expanding upon     our prior findings and using an innovative approach combining two models of the social     cognitive theory (SCT) and the RE-AIM framework (Reach, Effectiveness, Adoption,     Implementation, Maintenance), in this proposal, we propose a large scale online study (N =     866) that will compare the long-term impact of two SCT-based online bone health interventions     in adults age 50 and older targeting two large online communities. The two interventions are     (1) an 8-week SCT-based Online Bone Health (TO-BoneHealth) program and (2) a 12-month     TO-BoneHealth Plus program, including the TO-BoneHealth program followed by biweekly     theory-based eNewsletters with follow-up of each individual's bone health behaviors     (booster intervention) for 10 months. The interventions' impact will be assessed on the     following the modified RE-AIM framework: (a) Effectiveness (knowledge, selected bone health     behaviors, fall incidence, initiation of a discussion about bone health with a primary care     provider, eHealth literacy); (b) Reach (number of participants the program reached); (c)     Implementation (program usage); and (d) Maintenance (participants' bone health behavior     maintenance). With the rapid growth of online communities, findings from this study will     significantly contribute to current eHealth practice and research and serve as a     dissemination model for other health promotion projects targeting online communities.   "
101073|NCT01963156|"     The aim of this study is to evaluate if synchronizing when patients with diabetes and/or     coronary artery disease fill their prescriptions improves long-term adherence to these     medications.   "
101074|NCT01963143|"     The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous     immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a     28-day dosing interval (AUC0-28) in a cohort of adult subjects.      The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and     Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval     (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and     Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the     safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to     assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to     investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.   "
101075|NCT01963130|"     This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal     vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.   "
101076|NCT01963117|"     The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is     chemotherapy, but considerable portion of the patients progressed and most of the liver is     converted to metastatic tumor lesions. Significant quality of life decrement was detected in     those patients, especially in patients suffered severe symptoms Several studies reported that     whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable     liver metastasis in gastrointestinal tract cancer patients. However, it is well known fact     that the liver is a very sensitive to RT. Despite symptom palliation is obtained after 20 to     30 Gy RT but only in small subset of patients get local control. In this aspect, the combined     with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and     control local tumor progression, and increase the quality of life ultimately.      It is reported that hyperthermia is considered as the most valuable radiosensitizer in cancer     treatment, theoretically. Based on those studies, we start this prospective study to     investigate the effect of combination treatment of WLRT and hyperthermia on quality of life     in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract     cancer.   "
101077|NCT01963104|"     The overall goal of the project is to evaluate innovative, cost-effective, community-based     automated hearing screening and education methods to motivate individuals with     mild-to-moderate hearing loss to enter the hearing healthcare system.   "
101325|NCT01959854|"     The purpose of this study is to evaluate the effect of an ophthalmic solution containing 0.2%     xanthan gum in reducing symptoms and signs of dry eye as well as tear film markers of     oxidative stress.   "
101326|NCT01959841|"     To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with     valaciclovir (VACV) 3000 mg in patients with herpes zoster.   "
101078|NCT01963091|"     Stress is associated with drug craving and relapse in substance-dependent individuals.     Hormones released from the brain may mediate the behavioral response to stress. For example,     several studies have indicated that oxytocin reduces stress in laboratory stress paradigms.     Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet,     little is known about the potential affects of oxytocin in cocaine-dependent individuals.     Given these properties of oxytocin, it may have a therapeutic role in ameliorating the     negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well     as the anxiety associated with withdrawal. This pilot protocol will provide important     preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.   "
101079|NCT01963078|"     The purpose of the study is to use fMRI to investigate amygdala response to fearful faces in     men and women with and without PTSD who have experienced childhood trauma. The study will     also compare the effects of oxytocin and placebo on amygdala response, and explore the     interaction of oxytocin plasma levels and amygdala response in men and women with and without     PTSD who have experienced childhood trauma.      Hypothesis 1: Amygdala responding will be greater in subjects with PTSD as compared to     resilient subjects, and no sex differences in the magnitude of the response will be found.      Hypothesis 2A: In response to OT, women will exhibit a greater reduction in amygdala     responding than men.      Hypothesis 2B: In response to OT, women with PTSD will exhibit a greater reduction in     amygdala responding compared to women without PTSD.      Hypothesis 3A: Women with PTSD will have lower levels of plasma OT as compared to men with     PTSD, and women and men without PTSD.      Hypothesis 3B: Plasma OT levels will be inversely correlated with amygdala responding to     fearful faces in women but not in men.   "
101080|NCT01963065|"     The purpose of this study is to evaluate whether babies are exposed to significant levels of     chemicals during their stay in the neonatal intensive care unit (NICU). For example, other     research studies have shown that babies are exposed to plasticizers (bisphenol A, phthalates)     in the NICU. Plasticizers are chemicals that are used to make plastic medical equipment soft     and flexible. The research team wants to find out whether the amount of plasticizer and other     chemicals babies may be exposed to in the NICU makes a difference in how they grow and how     they perform on neurologic tests.   "
101081|NCT01963052|"     The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and     anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at     least one prior chemotherapy regimen for metastatic disease.   "
101082|NCT01963039|"     Background The standard care in patients with a painful osteoporotic vertebral compression     fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally     invasive technique, is a relatively new treatment option. Recent randomized controlled trials     (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while     an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in     patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs     defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of     patients still had disabling pain after 3 months or longer. These patients with sustained     pain after 3 months may benefit from PV.      Objective To compare pain relief after PV with a sham intervention in selected patients with     a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria     as in VERTOS II an IV. Secondary outcome measures are back pain related disability and     quality of life.      Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint.     Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture     level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS)     score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age     50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed.     Follow-up is at regular intervals during one year period with VAS score for pain as primary     endpoint. Secondary endpoints are back pain related disability and quality of life measured     with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and     physical function measured with the Roland Morris Disability questionnaire.      Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of     vertebroplasty in patients with sustained pain 3 months or longer after a vertebral     compression fracture.   "
101083|NCT01963026|"     Introduction In recent years, client-centred and task-oriented training have emerged as     important methods in rehabilitation including the rehabilitation of persons with spinal cord     injury (SCI). The task-oriented intervention focuses on resolving, reducing and preventing     impairment, developing effective task-specific strategies and adapting functional     goal-oriented strategies to changing environmental conditions. Currently, task-specific     training is mainly achieved by constant practice (i.e. repeating the task without variation)     and is reported to improve performance of the trained task, but to have a negative impact on     untrained tasks. Practice variability, however, is reported being advantageous to transfer     training results into daily live. This paradox poses challenges in clinical practice, where     task-specific training is essential to deliver client-centred training in order to focus on     the patients' specific individual goals, but practice variability is important to be able to     transfer the learned task into daily practice. Questions regarding the effective elements     within rehabilitative interventions and the exact mechanisms behind the cerebral changes they     may induce, remain. These questions require further research, for which ultra-high field fMRI     techniques will be used. Furthermore, compensation of muscle function loss (i.e. the     development of new muscle synergies) plays an important role in the improvement of skill     performance in cervical SCI. Surface EMG allows to study the changes in muscle coordination,     parallel to the changes at cerebral level.      Aims This study aims to        1. investigate which basic neural mechanisms of motor learning underlie functional recovery          of arm hand skilled performance during client-centred task-oriented training of the          upper limb in patients with cervical spinal cord injury and        2. investigate the contribution of 'practice variability' in contrast to 'constant          practice' on arm-hand skilled performance, motor control and neural changes.      Study design This study features a multiple single-case experimental design (A-B-C design)     with baseline (phase A) (6 weeks), intervention B (phase B) (3 weeks) and intervention C     (phase C) (3 weeks). Intervention B will contain the 'practice variability' component.     Intervention C will feature the 'constant practice' component. The order of phase B and C     will be randomly assigned to participants. Four measurements during baseline and after each     intervention phase (B and C) will be performed, thus producing a time series, per measure,     for each patient. Also, meta-analyses on the pooled single-case data will be performed.      Setting/population Six patients with a cervical SCI (complete and incomplete) will be     recruited from the Spinal cord unit of Adelante Rehabilitation Centre in the (sub)acute     phase.      Intervention After therapy as usual (intervention A), the Task-oriented Client-centred Upper     Extremity Skill Training (ToCUEST) module (Spooren et al., 2011) will be provided. In this     program individual goals will be extracted using the Canadian Occupational Performance     Measure(COPM) and the training program is based on a task-analysis and uses principles of     training physiology and motor learning. Intervention B will consist of the ToCUEST program,     including the component 'practice variability' (ToCUEST variability). Intervention C will     consist of a modified ToCUEST program in which the component 'practice variability' will be     replaced by 'constant practice' (ToCUEST constant) in order to evaluate the contribution of     these components. Intervention A' will be therapy as usual.      Measurements Measurements will be taken at the level of activities (arm hand skilled     performance, i.e. Van Lieshout Test, Spinal Cord Independence Measure, Goal Attainment Scale)     and body function (Upper Extremity Motor Score, Graded Redefined Assessment of Strength     Sensibility and Prehension Test, Surface EMG), and at cerebral level, i.e. neural activity     changes (by means of ultra-high field fMRI).      The fMRI measurements will be taken before and after each intervention B and C in 4 patients     (2 with complete and 2 with incomplete lesion).      Data-analyses Baseline data stability and any baseline trends regarding the outcome measures     at body function level and activity level will be assessed. To control for, e.g., spontaneous     recovery effects, baseline data (phase A) will be used in a computer-based detrending model.     For the meta-analyses, mean data per outcome measure, per phase, per subject will be pooled     and subsequently analysed using non-parametric statistics, i.e. Friedman analyses and     Wilcoxon tests.   "
101084|NCT01963013|"     This study was to determine efficacy of the non-returning catheter valve for reducing     catheter associated urinary tract infection compared with conventional urine bag in     critically ill patients.   "
101085|NCT01963000|"     Community acquired pneumonia (CAP) is associated with a high in-hospital mortality.     Standardization of diagnostics and adherence to sepsis bundles in the emergency department     (ED) are associated with reduced mortality in patients with sepsis. Investigators examined     whether the introduction of standardized care bundles and check lists in the ED are     associated with a reduced mortality rate in patients hospitalized for CAP.      This is an observational trial. The investigators retrospectively analyzed performance     indicators of 2819 consecutive patients with CAP admitted to the Nuremberg Hospital, Germany,     from 2008 to 2009. At the turn of the year, implementation of CAP care bundles took place     including interprofessional education, checklists and institutionalized feedback. Primary     endpoint was in-hospital mortality of CAP patients. After the implementation of CAP care     bundles in the ED, mortality of affected patients was significantly lower in 2009 compared to     2008. This study should demonstrate that the implementation of a standardized CAP care bundle     in the ED is associated with a risk reduction in affected patients. Standardization of     diagnostic and therapeutic processes in the ED therefore improves the outcome of patients     hospitalized for CAP.   "
101086|NCT01962987|"     To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3%     (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)     in the treatment of the actinic keratosis   "
101087|NCT01962974|"     This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects     with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease     control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in     28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα     therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg     every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.      To be eligible for participation, subjects must have previously demonstrated initial and/or     temporary improvement in disease signs and symptoms, who have since exhibited a diminished     response despite continued treatment. It is estimated that 200 subjects will be enrolled in     the study at approximately 85 global sites.   "
101088|NCT01962961|"     The goal of this study is to determine if n-acetylcysteine, given as PharmaNAC, reduces     oxidative stress and improves vascular function in HIV-infected older adults already on HIV     treatment.   "
112045|NCT01819337|"     The aim of this study is to identify if there exists a correlation between the preoperative     cardiopulmonary capacity - measured in MET's - and the perioperative lactate serum level.   "
101089|NCT01962948|"     This phase I/II trial studies the side effects and best dose of ganetespib when given     together with paclitaxel and to see how well they work in treating patients with recurrent     ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Ganetespib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving paclitaxel and ganetespib may be     an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer.   "
101090|NCT01962935|"     Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or     with AZD 5069   "
101091|NCT01962922|"     Open label, prospective, single-center, randomized, two sequence, three period crossover     study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus     capsules administered twice daily in stable African-American renal transplant patients.   "
101092|NCT01962909|"     The purpose of this clinical trial is to study an experimental drug called PTP-01 that is     being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer     is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early     stage disease. Researchers at the University of Virginia have identified a biomarker for     pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other,     non-cancerous conditions involving the pancreas. These researchers have also developed     PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer     cells in humans.   "
101093|NCT01962896|"     The purpose of this study is to find out if the combination of an mTOR inhibitor (sirolimus)     with an EGFR inhibitor (erlotinib) is effective at treating relapsed or refractory germ cell     tumors, and to find out what the side-effects of this regimen are.   "
101094|NCT01962883|"     The proposed study is a randomized clinical trial with the purpose of determining the     efficacy of osteopathic treatment on vestibular symptoms of the post concussed vestibular     disturbed athlete as determined by the Dizziness Handicap Inventory (DHI) and the Balance     Error Scoring System (BESS). Of secondary interest, this study will evaluate the osteopathic     assessment findings of this population and side effects, positive and negative, associated     with the osteopathic treatment provided.      Primary Hypothesis        1. Osteopathic treatment will have no effect on the symptoms of dizziness of the vestibular          disturbed post concussed athlete using the Dizziness Handicap Inventory        2. Osteopathic treatment will have no effect on the balance recovery of the vestibular          disturbed post concussed athlete using Balance Error Scoring System (BESS)           Secondary Hypothesis        3. To determine the side effects of osteopathic treatment of the vestibular disturbed post          concussed athlete   "
101095|NCT01962870|"     Researchers at the Stanford University School of Medicine are seeking participants for a     study examining the effectiveness of vasopressin, a neuropeptide, in treating children with     autism spectrum disorder. Difficulty with social interactions is characteristic of people     with autism, who often have problems interpreting facial expressions or maintaining eye     contact while talking with someone. There are currently no effective medicines available to     treat social problems in individuals with autism. Neuropeptides, such as vasopressin and     oxytocin, are molecules used by neurons in the brain to communicate with one another.     Vasopressin is closely related to oxytocin, which is currently being tested as a treatment     for autism, and has been shown to enhance social functioning in animals. Animal studies have     shown that when the proper functioning of vasopressin is experimentally altered, animals     develop a variety of social deficits, including impaired memory for peers and a reduced     interest in social interaction. Researchers found that when vasopressin was administered to     mice with a genetically induced form of autism, their social functioning improved.     Vasopressin is already approved by the Food and Drug Administration for use in humans, and     has proved to be a successful treatment for some common pediatric conditions, including     bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and     memory in people who do not have autism. The researchers will test the effects of vasopressin     on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study     will last four weeks for each participant. Participants will receive either vasopressin or a     placebo nasal spray. At the end of this phase of the study, those who received the placebo     will have the option of participating in a four-week trial during which they will be given     vasopressin. Stanford is the only site for the study. Participants do not need to live     locally but will need to come to the Stanford University Department of Psychiatry and     Behavioral Sciences for study visits.   "
101096|NCT01962857|"     A number of studies have shown that short duration, high intensity interval training can     improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness.     However, these often use specialized equipment, such as cycle ergometers, which makes it     difficult to roll these interventions out for wide-scale use in the general population. This     study aims evaluate the effects of a high intensity shuttle running intervention on insulin     sensitivity, fitness and related cardiometabolic risk factors in men who are currently     inactive. Participants will be randomized into intervention (4 weeks of shuttle running) and     control groups. We hypothesize that the shuttle running programme will result in improved     insulin sensitivity, fitness and increased fat oxidation at rest compared with the control     group.   "
101097|NCT01962844|"     The purpose of this study is to evaluate the supplementation with extra virgin of coconut oil     combined with a nutritional counseling in reducing anthropometry and improves the lipid     profile in patients with chronic coronary disease.   "
101098|NCT01962831|"     The purpose of this study is to compare the efficacy of single balloon foley catheters to     dinoprostone for the induction of labour of obese women. The investigators suspect that women     assigned to the foley group will have a shorter induction to delivery time than women in the     dinoprostone group.   "
101099|NCT01962818|"     Background Ventilator induced lung injury (VILI) remains a problem in neonatology. High     frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal     pressure fluctuation around a continuous distending pressure and therefore small tidal     volume. Animal studies showed that recruitment and maintenance of functional residual     capacity (FRC) during HFOV (open lung concept) could reduce lung injury.      Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using     oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with     recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a     rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation,     quicker weaning and shorter ventilation. This may be related to improved lung recruitment.      Electric Impedance Tomography (EIT) enables measurement and mapping of regional ventilation     distribution and end-expiratory lung volume (EELV). EIT generates cross-sectional images of     the subject based on measurement of surface electrical potentials resulting from an     excitation with small electrical currents and has been shown to be a valid and safe tool in     neonates.      Purpose, aims:        -  To compare HFOV-sigh with HFOV-only and determine if there is a difference in global and          regional EELV (primary endpoints) and spatial distribution of ventilation measured by          EIT        -  To provide information on feasibility and treatment effect of HFOV-sigh to assist          planning larger studies. We hypothesize that EELV during HFOV-sigh is higher, and that          regional ventilation distribution is more homogenous.      Methods:      Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will     be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4     alternating 1-hours periods (2-treatment, double crossover design, each patient being its own     control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV     will remain at pretrial settings.      16 ECG-electrodes for EIT recording will be placed around the chest at study start. Each     recording will last 180s, and will be done at baseline and at 30 and 50 minutes after each     change in ventilator modus.      Feasibility No information of EIT-measured EELV in babies on HFOV-sigh exists. This study is     a pilot-trial.      In a similar study-protocol of lung recruitment during HFOV-sigh using a/A-ratio as     outcome, 16 patients was estimated to be sufficient to show an improvement by 25%. This     assumption was based on clinical experience in a unit using HFOV-sigh routinely. As the     present study examines the same intervention we assume that N=16 patients will be a     sufficient sample size. We estimate to include this number in 6 months.   "
101100|NCT01962805|"     This study is a double-blind crossover study in female healthy volunteers to compare the     pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations     of Proellex for vaginal administration. Each formulation will be designated as either     Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be     randomized to receive either Treatment A or Treatment B as their first assigned treatment.     Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6     days. After a 7-day washout period subjects will receive the alternative treatment. On the     day of treatment with Treatment A and on the first and last days of treatment with Treatment     B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment     at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after     administration of study drug. For Treatment B study drug will be administered in the clinic     each day after a trough blood sample has been drawn.   "
101327|NCT01959828|"     Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary     hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety     and efficacy of IK-3001.   "
101102|NCT01962779|"     Our preliminary data show for in cognitively-normal elderly, that Sleep Disordered Breathing     (SDB) is associated with the increase of cerebrospinal fluid (CSF) phosphorylated-Tau (P-Tau)     and total-Tau (T-Tau), decreases in medial temporal lobe glucose uptake (FDG-PET) and volume     (MRI) and progressive memory decline, all of which have been shown to be useful in predicting     future dementia in older adults. These findings raise the question as to whether Alzheimer's     disease (AD) tissue damage causes SDB in the elderly, or alternatively, if SDB acts as a risk     factor for AD neurodegeneration. In the proposed study, we will investigate these mechanistic     hypotheses in cognitively normal elderly by examining the longitudinal associations between     SDB and cognitive decline, novel MR neuroimaging and CSF biomarkers for neurodegeneration;     while our secondary goal is to launch a pilot treatment study to aid in interpreting the     mechanistic hypotheses and to examine the effects of nasal continuous positive airway     pressure (CPAP) on cognitive decline and neurodegeneration.   "
101103|NCT01962766|"     The current research project aims to study the efficacy of myofunctional therapy and its     orthodontic long-term outcomes.   "
101104|NCT01962753|"     The primary objective of the study is to compare the brain amyloid load in fully, partially     and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using     PET with [F18]AV45.   "
101105|NCT01962740|"     The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical     Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three     second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA),     Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston     Scientific, Natick, MA)] at 6 weeks post implantation.      Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience     EES, Promus EES and will be similar to each other and improved (higher rates of stent strut     coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks     post-implantation.   "
101106|NCT01962727|"     Study Design: Clinical measurement (cross-sectional)      Objectives: The purpose of this study was to investigate the reliability and validity of the     novel scapular dyskinesis classification test.      Background: A visual-based clinical assessment with sufficient reliability and validity to     identify scapular dyskinesis provides information for rehabilitation treatment.      Methods: A visual-based palpation method was evaluated by two independent physiotherapists in     60 subjects with unilateral shoulder pain to test reliability. This method classified the     scapular movements during arm raising/lowing movements in scapular plane as single abnormal     scapular patterns (inferior angle/ medial border/ superior border of scapula prominence and     abnormal scapulohumeral rhythm) or mixed abnormal scapular patterns. Different patterns of     scapular dyskinesis were also validated by corresponding alternation of the scapular     kinematics and muscular activities assessed by electromagnetic motion-capturing system and     surface electromyography (EMG).   "
101107|NCT01962714|"     This randomized controlled trial will assess whether a novel complementary and alternative     medicines (CAM) intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior     to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only version;     CPT-C) for reductions in PTSD and depressive symptoms. 170 male and female Veterans with     current PTSD will be randomized to LKM or CPT-C. The investigators hypothesize that Veterans     randomized to LKM will report mean reductions in PTSD and depressive symptom severity that     are not meaningfully worse than CPT-C. The investigators further hypothesize that reductions     in posttraumatic maladaptive beliefs will more strongly mediate PTSD and depressive symptom     improvement for those assigned to CPT-C than those assigned to LKM.   "
101108|NCT01962701|"     The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is     studied.   "
101109|NCT01962688|"     The purpose of this study is to see if using a portable handheld ultrasound to guide diuretic     therapy for heart failure patients will prevent hospital readmissions. This study will use a     handheld ultrasound called a Vscan to look at a large vessel in the body called the Inferior     Vena Cava (a vein leading to your heart) . The study aims to see whether changing diuretic     therapy based on the size of this vessel will result in the less hospitalizations for heart     failure patients as compared to just symptom guided therapy. This study is composed of two     independent non-interacting trials—one in the outpatient setting and one in the inpatient     setting.   "
101110|NCT01962675|"     The study investigates the effect of using transcranial direct current stimulation (tDCS) and     skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle     and leg motor control in persons with ambulatory persons with spinal cord injury.      Hypotheses H1: Participants will display greater improvement in stepping function following     tDCS combined with training compared to sham-tDCS and training.      H2: Participants will display greater gains in cortical excitability, as evidenced by lower     cortico-motor threshold (MT) associated with the TA muscles following tDCS and training     compared to following sham stimulation and training.      H3: Participants in the tDCS+training group will show greater increases walking speed in a     timed 10 meter walking trial.      H4: Participants in the tDCS+training group will show be able to perform a greater number of     toe-taps test.   "
101124|NCT01962480|"     Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh     reinforcement has gained increasing acceptance among surgeons despite creating a     tension-based repair. Beneficial effects of this technique have sporadically been reported     but no evidence is available from randomized controlled trials.      The primary purpose is to compare early postoperative activity-related pain in patients     undergoing ventral hernia repair with closure of the gap with patients undergoing standard     laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis     and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence     and chronic pain after 2 years.      Material and Methods: A randomized, controlled, double-blinded study is planned. Based on     power calculation we will include 40 patients in each arm. Patients undergoing elective     laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre     Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to     participate.      Conclusion: The technique with closure of the gap may induce more postoperative pain, but may     be superior with regard to other important surgical outcomes. No studies have previously     investigated closure of the gap in the setting of a randomised controlled trial.   "
101111|NCT01962662|"     Force generation and force level control are important neuromuscular control mechanism for     successful execution of movement for our daily activities. Impaired force level control is a     major deficit of motor control in people with stroke. Electromyographic biofeedback (EMG     biofeedback) has been suggested by researchers and clinicians to be a useful and effective     tool for enhancing control of force level during motor skill learning for people with stroke.     Based on the concept of motor-skill learning, practice with variable force levels may be more     effective than practice with a constant force level to enhance movement performance. The EMG     biofeedback provides a suitable tool for such practice of force level control and hence for     motor skill learning. However, research literatures thus far have yet to provide convincing     evidences to support this claim. Neural imaging studies have shown corresponding brain     reorganization and neural plasticity following physical practice of movement skills in people     with stroke. It is curious whether EMG biofeedback augmented physical practice of motor     skills enhances brain reorganization. Using brain mapping techniques, in particular, the     transcranial magnetic stimulation (TMS), we could investigate neural plasticity accompanying     motor function changes induced by physical training, and hence may help to develop safer and     more effective training parameters. The purpose of this study is to examine the effects of     variable practiced EMG biofeedback training emphasized on force level control of the ankle     muscle on balance and gait performance and the corresponding changes of corticospinal     excitability using TMS in people with chronic stroke.   "
101112|NCT01962636|"     This is a treatment guideline for an unrelated umbilical cord blood transplant (UCBT) using a     myeloablative preparative regimen for the treatment of hematological diseases, including, but     not limited to acute leukemias. The myeloablative preparative regimen will consist of     cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI).   "
101113|NCT01962623|"     The purpose of this study is to determine the feasibility and acceptability of utilizing an     adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for     Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood     dysregulation disorder (DMDD).      The investigators hypothesize that retention rates will be >80%, satisfaction scores will     average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT     intervention will have overall improvement in SMD/DMDD symptoms.   "
101114|NCT01962610|"     The goals of this exploratory study are to determine the feasibility of integrating     electronic clinical decision support into routine clinical pain care for adults in the ED     setting and gather data on whether or not such clinical decision support is effective in     improving pain care outcomes in the ED. The use of an electronic pain care alert (ePCA)     prompting doctors to provide acute pain care for adult patients with complaints of severe     abdominal pain will be compared to patients seen by clinicians with routine ED care.      Hypothesis: The ePCA will improve the quality of acute pain care for patients.   "
101115|NCT01962597|"     Study Hypothesis: The combination of aerobic and resistance exercise training will improve     walking speed compared to either individual intervention.      Brief Summary:      Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized     to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a     bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The     primary outcome is walking speed over 4-metres. Secondary outcomes will include:      (i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L];     (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL)     index; (v) Leg strength; (vi) body composition and anthropometry.   "
101116|NCT01962584|"     To evaluate the additive values of T1 mapping in patients with acute myocarditis.   "
101117|NCT01962571|"     This clinical trial aims at preventing visual dysfunction and optic nerve degeneration     associated with autoimmune optic neuritis by systemic i.v. administration of 33.000 IU     erythropoietin over 3 days. The primary objective is to determine the efficacy of     erythropoietin compared to placebo given as add-on to methylprednisolone as assessed by     measurements of retinal nerve fibre layer thickness and low contrast visual acuity 6 months     after acute optic neuritis.   "
101118|NCT01962558|"     Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized,     controlled, parallel study design.   "
101119|NCT01962545|"     The purpose of the study is to evaluate non-inferiority of oral anticoagulant (OAC)     monotherapy to OAC plus single antiplatelet therapy (APT) in patients with atrial     fibrillation (AF) and prior (>12 months) coronary stenting.   "
101120|NCT01962532|"     The purpose of this study is to determine a dose for future development and to evaluate the     safety, pharmacokinetics, pharmacodynamics, and efficacy profiles of JNJ-42756493 in Japanese     and other Asian patients with advanced or refractory solid tumors or lymphoma.   "
101121|NCT01962519|"     The aim of this study is to evaluate the possibility of shortening postoperative hospital     stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol     (ERAS).   "
101122|NCT01962506|"     Rapid and reliable exclusion of acute myocardial infarction (AMI) during an emergency     department (ED) triage is a major unmet clinical need. We aimed at verifying the     non-inferiority of a single-sampling strategy of hs-cTn and copeptin compared with the dual     hs-cTn sampling for the early diagnosis of Non-ST-Elevation Acute Coronary Syndromes     (NSTE-ACS) versus Non Coronary Chest Pain (NCCP) in a selected cohort of consecutive patients     admitted at the Emergency Department.   "
101123|NCT01962493|"     The aim of this study is to compare the stain effect on teeth of twice daily brushing with a     67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing     sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.   "
101139|NCT01962285|"     Loss and recovery of consciousness during propofol anesthesia seem to be mediated by     different mechanisms beyond the actual effect-site concentration of anesthetic drug. This     eventual difference between dose response curves for loss of consciousness (LOC) and for     recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia.     We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate,     stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state     conditions between plasma an effect-site concentration, there is still going to exist a     difference between LOC and ROC, demonstrating the existence of neuronal inertia.   "
101125|NCT01962467|"     This is an open label, randomized, 3-way cross-over, and repeat administration study in     healthy male and female subjects. The purpose of the study is to determine the relative     bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is     administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A     (in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18     subjects will be enrolled). Each part will consist of three treatment periods separated by a     minimum washout period of 14 days. In each treatment period, subjects will receive seven     daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray     according to one of the 6 possible randomization sequences. The study will use an adaptive     design with an interim review following Part A to confirm whether Part B is required.   "
101126|NCT01962454|"     This is a single-blind, randomized placebo-controlled, parallel study, where the study     volunteers will be blinded to testosterone/placebo treatment. This study will test a     relatively new, less invasive method for collecting muscle tissue to determine if this method     is appropriate for collecting muscle samples for the assessment of the fractional synthetic     rates (FSR) of muscle-derived proteins. This study will also investigate whether the FSR of     proteins may serve as early biomarkers for muscle anabolism, a known anabolic agent     (testosterone) will be administered to healthy, elderly male subjects over a 3 week period.     The fractional synthetic rate of several muscle-derived proteins will be analyzed at Baseline     and during the period of testosterone treatment using deuterium labelling of these proteins     by the incorporation of deuterium from deuterated water (D2O).   "
101127|NCT01962441|"     This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir     (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in     treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus     (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV     infection.   "
101128|NCT01962428|"     It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus     conventional loading dose(180mg) will result in a higher inhibition of platelet     aggregation(IPA) without increasing the bleeding events.   "
101129|NCT01962415|"     The objective of this study is to evaluate the efficacy of using a reduced-intensity     condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT,     matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell     transplant (PBSCT) in patients with non-malignant disorders that are amenable to treatment     with hematopoietic stem cell transplant (HSCT). After transplant, subjects will be followed     for late effects and for ongoing graft success.   "
101130|NCT01962402|"     The purpose of this study is to determine whether lorcaserin is effective for weight     reduction in patients with weight gain as a result of antipsychotic medications.   "
101131|NCT01962389|"     The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for     the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)   "
101132|NCT01962376|"     The investigators assessed whether the addition of a preoperative regimen of Bevacizumab     regimen to improves R0 resection rate and survival among patients with potentially resectable     gastric cancer with liver metastasis.   "
101133|NCT01962363|"     The purpose of this study is to evaluate the effects of EPI-743 in patients with Friedreich's     Ataxia point mutations   "
101134|NCT01962350|"     The treatment of bipolar disorders is always a challenge in daily practice. Mood stabilizers     are partially effective in the treatment of depressive phase of the illness, although there     are some reports relating to the antidepressant properties of these drugs. Other conventional     methods (pharmacological) and non- conventional treatment are not effective or involve risks     and side effects. Several studies with Transcranial Magnetic Stimulation (TMS) showed that     magnetic stimulation daily over the left prefrontal cortex may improve the mood of patients.     TMS is a noninvasive method of stimulating the brain. The instrument used nowadays in local     research and application Clinical is a metallic coil formed in figure 8 (coil format 8). This     instrument was capable of stimulating only surface areas of the brain, primarily the cerebral     cortex, at depths of up to 3 inches below the scalp. From this angle, there is clearly a need     for a means of producing magnetic fields which can reach deeper brain areas, such as those     involved in mood disorders. TMS has little, if any effect in these brain areas. To this end,     new coils, calls H, that promote the stimulation of deep brain areas were developed in     collaboration with the National Institute of Health (NIH) in the USA. This new coil - H1 that     will be evaluated in this study has been tested for safety in NIH in 2003 by Dr. Abraham     Zangen. Yet there are very few prospective clinical, randomized and controlled trials, on the     effects of early and late in clinical-cognitive condition and safety of TMS with H1 coils in     treating episodes of bipolar depression. The application of EMT with H1 coils can reach     deepest regions of the brain and improve the clinical and cognitive condition of subjects     with episodes of bipolar depression, and may be confirmed as a safe and virtually free of     side effects. By an absence of treatment actually effective for bipolar depression, this     study will show whether there are clinical and cognitive benefits of deep TMS with H1 coil in     patients with bipolar depression.   "
101135|NCT01962337|"     This is a Phase 1, randomized, double-blind, placebo-controlled study designed in 3 parts to     assess the safety, tolerability, and PK of single and multiple ascending doses of FPA008 in     adult healthy volunteers (Parts 1 and 2) and adult subjects with active RA (Part 3).   "
101136|NCT01962324|"     A single arm phase 2 study to study the outcome of dose-escalation with simultaneous     integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients     with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be     included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is     that we will have fewer relapses in this very high risk patient group compared to matched     historical controls with acceptable side effects.   "
101137|NCT01962311|"     This project is expected to answer the question of interest assays of metabolites in the CSF     as a tool for early diagnosis and should show whether it is possible or not to use such     markers in the blood or urine. These studies should also help shed light on the     pathophysiological original early clinical disease. While ALS appears to be more a clinical     syndrome that pathophysiological entity unique metabolic abnormalities identified could help     identify mechanisms disrupted in which therapeutic interventions will be possible.   "
101138|NCT01962298|"     The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle     activity is well known. However, since the availability of sugammadex, to our knowledge, no     study has been conducted to evaluate the effect of this novel product on these muscles.      Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking     agents and their reversal agents we might see a different activity of the respiratory     muscles.   "
112071|NCT01818999|"     This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in     combination with Ixabepilone for women with triple negative metastatic breast cancer.   "
101141|NCT01962259|"     The aim of present randomized controlled trial is to evaluate the health effects of physical     activity in transport and leisure time domains of everyday life and to develop durable     physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle     routine, in overweight individuals.      Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical     activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4:     a non-intervention control group   "
101142|NCT01962246|"     Stage I：preoperative therapy        -  Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone          ; Stage II: Perioperative therapy        -  Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to          adjuvant Capecitabine plus oxaliplatin alone;        -  A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with          incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal          cancer . The investigators assessed whether the addition of a perioperative regimen of          XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate          and survival among patients with curable locally advanced adenocarcinoma of stomach and          gastroesophageal cancer   "
101143|NCT01962233|"     This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem     Cells transplantation in hypoxic ischemic encephalopathy.   "
101144|NCT01962220|"     Linking HIV-infected pregnant women into prevention of mother to child transmission (PMTCT)     services and keeping them in care is important in ensuring that both mother and infant beneﬁt     from interventions that improve maternal health and decrease HIV transmission to infants. We     propose an evaluation of strategies to link newly diagnosed HIV-infected women to care and     keep them in care during pregnancy and after delivery in our study called MIR4HEALTH. The     study will be conducted in Nyanza Province, Kenya. All participants will provide informed     consent and will be randomized to receive the intervention, including individualized patient     education, adherence support and phone call/Short Message Service (SMS) reminders for clinic     appointments, or the standard of care (no additional intervention services).   "
101145|NCT01962207|"     The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10     years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT     versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of     MenACWY-TT administered 10 years after the primary vaccination. All subjects received a     primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects     will be enrolled in this booster study.   "
101146|NCT01962194|"     The investigators hypothesize that the emotional and cognitive areas of the Subthalamic     Nucleus (STN) have distinct electrophysiological properties and that specific stimulation of     these areas can influence the mental and the emotional state. Parkinson's disease (PD; n=5)     and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with     Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) will be recruited over a period of two     years. The patients will be enrolled in a prospective, open label, clinical trial and will be     followed for one year. No randomization or blinding will be used in this study.   "
101147|NCT01962181|"     In this study we try to identify the signature of brain activity in the EEG of attention     deficit disorder (ADHD) patients compared to healthy subjects under different doses of     Ritalin (methylphenidate) treatment.   "
101148|NCT01962168|"     The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially     available device to gather physician experience with the Cook Evolution® Biliary Stent System     for the palliation of cancer in the biliary tree. Patients will be treated as per usual     medical practices.   "
101149|NCT01962155|"     The aim of our prospective study is to construct and validate a non-invasive model consisting     biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis     caused by hepatitis B virus in mainland China.   "
101150|NCT01962142|"     Limitation of activity is one of the main item used by composites scores designed to assess     the level of asthma control. Since this item is systematically subjectively assessed by the     patient, the investigators would like to know if these subjective data are correlated with     objective data.      Aims of this study are: 1) To describe what means limitation of activity for asthma     patients and how they deal with; 2) To describe the objective exercise capacity and     characteristics of daily activity in two situations (on exacerbation, out of an     exacerbation).   "
101151|NCT01962129|"     The aim of this multicentre study will be to better describe the clinical characteristics and     the etiological bases of patients with OFD syndrome by identifying new genes involved in OFD     syndrome. These results will make it possible, from patients who have been clearly identified     from a clinical, cytogenetic and molecular point of view, to determine a study strategy in     such patients. The data obtained will be used to guide clinical geneticists in genetic     counselling for patients and their families.      Identification of the molecular bases of the different OFD syndromes will make it possible to     determine whether or not they belong to the group of ciliopathies like type I OFD and to     understand their physiopathological bases.      This study will also make it possible to better characterise the phenotype of boys with     syndromic mental retardation related to the OFD1 gene and thus to define the clinical     criteria of the study of this gene in boys with mental retardation.      The complete absence of knowledge concerning the genetic bases of OFD syndromes, apart from     type I, the presence of a large collection of samples from patients with OFD syndrome at     Dijon CHU, the recognition of the diagnostic laboratory for syndromic OFD at the     international level as well as the technical platform and expertise in molecular cytogenetic     methods including CGH-array and molecular genetics (sequencing, quantitative PCR, fragment     analysis) at the Cytogenetics and Molecular Biology laboratories at Dijon CHU justify the     implementation of such a study in 2010.   "
101211|NCT01961349|"     This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled,     phase III confirmatory study. The study will be partially double-blinded: the comparison     between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried     out in double-blind, but the comparison between Group 1 (placebo group) and Group 3     (ICI35,868 with EES0000645/A) will be carried out in single-blind.      The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be     moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic     polypectomy will be evaluated.   "
101152|NCT01962116|"     After obtaining written informed consent and inclusion, patients will be randomised into 2     groups for the type of dialysis catheter lock:        -  The first group will have a citrate lock        -  The second group will have a heparin lock Patients will be stratified according to the          centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.      The daily surveillance of patients will be no different from the usual surveillance of     patients on Renal Replacement Therapy.      The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.      The decision to withdraw the catheter will be made by the investigator and based on clinical     criteria (complications related to the catheter, termination of Renal Replacement Therapy…)   "
101154|NCT01962090|"     This study is designed to compare the short term effects of two different thoracic spine     thrust manipulation techniques on neck range of motion, pain, and self-reported disability in     a sample of dental students experiencing neck pain.      The hypothesis of the study is that there will be a difference between the two thoracic spine     thrust manipulation techniques for short term effects on neck range of motion, pain, and     self-reported disability in a sample of dental students experiencing neck pain.   "
101155|NCT01962077|"     assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary     molars with carious pulp exposure in comparison to Formocresol.   "
101156|NCT01962064|"     The purpose of this study is to examine the age and the neurodegenerative disease effects on     social cognition. Secondary goals are to better understand the relationships between     different component of social cognition, executive functioning, and behavior and describing     the neuronal substrates associated to the alteration of the social cognition in ageing and     dementia.   "
101157|NCT01962051|"     The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized,     multi-center post market clinical study.   "
101158|NCT01962038|"     The purpose of this study is examine the efficacy of a combination physical exercise and     cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive     Impairment.   "
101159|NCT01962025|"     The purpose of the pilot study is to determine: 1) Will patients agree to be randomized to     two different methods of putting needles in their arteriovenous fistula and, 2) if we can     adequately coordinate all of the sites to get useful multicentre trial data   "
101160|NCT01962012|"     The purpose of this study is to examine the amount of tooth movement achieved over time     between subjects undergoing aligner treatment using a pulsation device known as AcceleDent®     Aura with those not using the device.   "
101161|NCT01961999|"     The question of timing of initiation of renal replacement therapy (RRT), early versus     late, has seldom been the focus of high-quality or rigorous evaluation. As a consequence,     initiatives aimed at identifying the optimal timing of initiation of RRT in acute kidney     injury (AKI) have been given the highest priority for investigation by the Acute Kidney     Injury Network (AKIN). Accordingly, the investigators conducted a prospective, controlled,     interventional trial, comparing two treatment groups in which the only variable was the RRT     initiation strategy, to determine whether early versus late initiation in patients with     AKI after cardiac surgery is associated with a survival benefit or more favorable outcomes.   "
101162|NCT01961986|"     Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder     replacement (TSR).      Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder     replacement (TSR) is performed using the traditional surgical approach (called the     subscapularis release approach) as compared to patients who have a TSR procedure done using a     newer surgical approach (called the rotator cuff sparing approach).   "
101163|NCT01961973|"     Study Title: A study to compare two articular cartilage repair techniques in the knee joint:     The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells.      Study hypothesis: We start with the hypothesis that both treatments are equally effective.      Trial Design: The participating patients will be divided into two groups, each group     receiving either one of the treatment modalities. This study will not be randomised or     blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A     Shetty, who is one half of the team that devised both techniques. The post-operative     rehabilitation process will be the same for both groups.      Trial Participants: All participants will be from patients attending Professor Shetty's     clinic at the Spire Alexandra Hospital.      Planned Sample Size: 50 patients in each group      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3     months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and     assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm     scores; cartilage growth will be measured by the MOCART score.      Planned Trial Period: Two to three years      Primary Objective: To establish superiority, if any, of either procedure over the other by     studying pain relief, cartilage growth and improvement in function.      Primary Endpoint: At the end of the 2 year follow up for all participating patients.   "
101164|NCT01961960|"     The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374     in adults ≥61 years of age.   "
101165|NCT01961947|"     The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture     derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine     (TIV) in adults ≥20 and <65 years.   "
101166|NCT01961934|"     This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly     identify recurrent tumor versus post treatment effects (radionecrosis) in patients with     previously treated high grade brain gliomas.   "
101167|NCT01961921|"     The purpose of this study is to evaluate the safety and tolerability of long-term dosing with     ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).   "
102633|NCT01942759|"     The purpose of this study is to determine findings of positron emission tomography and     diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast     cancer and compare of two imaging modality in these patients.   "
101343|NCT01959620|"     The overall aim of this study is to determine the optimal dose, 3-session exposure     intervention versus 1-session exposure intervention compared to no treatment, for the     delivery of exposure therapy in the immediate aftermath of trauma for preventing the     development of posttraumatic stress disorder.   "
101506|NCT01957462|"     The aim of the current investigation is to develop new soft and more flexible 1-piece convex     ostomy products.   "
101168|NCT01961908|"     This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment cycles,     each with a 16 week active dosing period. Endometriosis pain, dysmenorrhea, non-menstrual     pelvic pain and dyspareunia (BBSS) as well as use of pain medications, and vaginal bleeding     intensity will be recorded using an electronic diary and Visual Analog Scale (VAS) pain     assessment will be utilized. All subjects will have completed an Off-Drug Interval (ODI)     prior to starting treatment. Visit 1 will be scheduled within a week before the next expected     menses (+/- 2 days), following the off-drug interval. Subjects will receive 2 cycles of     treatment separated by an off-drug interval (ODI), after which they will be followed until     menses has returned. During the follow-up period subjects will continue to record study     information in the electronic diary. The final follow-up visit will be scheduled after blood     flow has stopped.   "
101169|NCT01961895|"     The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus     block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery     for hip fractures, expressed as a reduction of ischemic events per subject.   "
101170|NCT01961882|"     To compare disease-free survival in patients 60 years or older with acute myeloid leukemia     (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.   "
101171|NCT01961869|"     This clinical trial studies black raspberry confection in preventing oral cancer in healthy     volunteers. Black raspberry contains ingredients that may prevent or slow the growth of     certain cancers.   "
101172|NCT01961856|"     In the PLATO substudy referring to patients presenting with an ST-elevation Myocardial     Infarction(STEMI), out of the 4201 who received ticagrelor, 1326 had been pre-treated with a     600mg clopidogrel loading dose (LD) within 24 hours prior to randomization. It is a logical     assumption, that patients who are being reloaded with ticagrelor will demonstrate reduced     platelet reactivity (PR) at 24 hours, in comparison to those who were initially loaded with     ticagrelor, due to the synergistic antiplatelet effect. Single loading with ticagrelor     though, will possibly be accompanied by a smaller bleeding potency compared to reloading with     ticagrelor. Therefore, we assume that single loading with ticagrelor is non-inferior to     reloading with ticagrelor, in terms of platelet reactivity.      P2Y12 inhibitor naive patients with STEMI, they will be randomized immediately after coronary     angiography (Hour 0) in receiving either Ticagrelor 180mg LD or Clopidogrel 600mg LD and 2     hours later reloading with Ticagrelor 180mg, after written informed consent. PR will be     measured, using the VerifyNow assay at randomization (Hour 0) and at 2, 4, 6 and 24 hours     post randomization. In addition, a 12-lead ECG will be performed before randomization, 90 and     180 minutes after the first balloon inflation, as well as on the exit day. Troponin I and     CK-MB will be assessed at randomization and at hour 4, 12, 24, 48 and 72 after randomization.      Non inferiority of Ticagrelor LD versus Ticagrelor re-LD would be accepted if the upper bound     of the 2-sided 95% CI around the estimated LS mean difference (Ticagrelor LD minus Ticagrelor     re-LD) in the primary end point (PR at 24 hours) would lie bellow Δ=35 PRU. This     non-inferiority margin (Δ) represents the upper bound of the LS mean difference in PR between     Ticagrelor and Prasugrel arm at 24 hours after LD in a pharmacodynamic study of 55 STEMI     patients.      Considering previous studies PR at 24 hours post randomization was estimated at 47±40 PRU and     41±35 PRU for Ticagrelor only LD and Ticagrelor re-LD group respectively. To obtain 85%     statistical power with a 2-sided alpha=0.05, approximately 32 patients in each treatment     group (64 in total) would be needed to establish the primary hypothesis using the     abovementioned non-inferiority margin of 35 PRU. Anticipating a 5% dropout rate, enrollment     was set to at least 68 patients. The primary endpoint, as well as PR at all the other time     points of the study will be analyzed separately via a mixed effect model with treatment as     fixed effect, patient as a random intercept and PR at baseline as a covariate. Least squares     estimates of the mean difference will be presented, with 95% confidence intervals and a     two-sided p-value for the treatment effect. P values for secondary endpoints will be reported     for two-tailed tests of superiority.   "
101173|NCT01961843|"     This research study is a Pilot clinical trial. Pilot clinical trials often examine new tests     (such as laboratory or radiology tests) in patients who receive either standard cancer     treatments or new treatments that have been well-tested in many patients on other trials.      It is often difficult to determine how prostate cancer is going to behave when a new     treatment is started. Physicians have no way to predict how a patient's tumor will respond to     treatment. Although scientists have learned about changes that happen in tumors due to     treatment, it is difficult to get cells from tumors because a biopsy (surgical procedure to     remove a small piece of tissue) is needed.      This study will evaluate a method to detect tumor cells that are circulating in the blood     without getting a biopsy. It is known that tumors shed a small number of cells into the blood     stream every day. These are called circulating tumor cells or CTCs. Some early studies     indicate the amount and type of CTCs in the blood can help determine the status of the tumor     itself and the way it is responding to treatment. In this study, the investigators will     examine protein levels in CTCs from patients' blood at different times before and after drug     treatment to determine if they correlate with response to the drug. The new test will not     affect whether subjects continue on the study drug.      Abiraterone acetate is a marketed drug that has been studied for the treatment of metastatic     CRPC. It blocks the remaining or residual male hormones in the body that may be helping     prostate cancer to grow. Abiraterone acetate is now FDA-approved for patients with metastatic     CRPC who have not yet received docetaxel chemotherapy.      Abiraterone acetate has been used by a large number of participants in previous clinical     trials. In most of these trials, participants with CRPC have been given abiraterone acetate     with prednisone. Prednisone is a man-made hormone commonly referred to as a steroid.     Prednisone has been approved in the US, Canada, and Europe for various disorders and     diseases, such as asthma, Lupus and chronic obstructive lung disease. The combination of     prednisone with abiraterone acetate has been approved for the treatment of CRPC. Prednisone     together with abiraterone acetate will be given in this study in order to reduce or eliminate     some side effects. Investigators will use patients' blood samples to study the genes (also     called DNA) and their products (RNA and proteins) found in CTCs.   "
101174|NCT01961830|"     This is a single-center, open-label, single-dose study. The primary objective is to determine     Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The     secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess     tolerability and safety of a single dose of ME1100 inhalation solution.   "
101175|NCT01961817|"     Is there a difference in vocal cord visualization between the retromolar and conventional     access?   "
101176|NCT01961804|"     The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist     treatment leads to a high risk of bleeding.      Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to     reverse anticoagulation with concomitant administration of prothrombin complex concentrates     (PCCs) and vitamin K.      However, even if a reversion is performed, the prognostic of post-traumatic intracranial     bleeding remain bad.      The investigators hypothesize that, for patients admitted in an emergency department after a     minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion     with PCCs can lead to a significant reduction of intracranial haemorrhage and can also     improve the neurological prognostic of patients versus the current strategy.      PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial     involving 400 patients.   "
101177|NCT01961791|"     For staging the status of lymph node metastasis in gastric cancer, typographic based staging     system was applied until last decade, especially in Eastern countries. However the old     typographic lymph node staging system in gastric cancer was too complicated and less accurate     for predicting the prognosis. Now the numeric based lymph node staging system is used in both     East and West, but it include problems: no information on the anatomical extent of the     disease, preoperative lymph node staging is nearly impossible, failure to provide an     appropriate treatment plan, cannot represent the extent of lymph node dissection. We designed     simple and specifically representing the anatomic extent of the disease for staging the     status of lymph node in gastric cancer. Thus we compared its prognostic performance of this     new staging system with those of the current TNM 7th edition of AJCC/UICC.   "
101179|NCT01961765|"     This research study is evaluating a drug called cabozantinib as a possible treatment for     acute myeloid leukemia (AML). This research study is a Phase I clinical trial. Phase I trials     test the safety of an investigational drug or combination of drugs. Phase I studies also try     to define the appropriate dose of the investigational drug to use for further studies. This     means that the FDA has not approved giving cabozantinib for use in patients, including     patients with your type of cancer.      The study drug cabozantinib works by inhibiting several different proteins which are believed     to be involved in the growth and multiplication of the cancerous cells associated with acute     myeloid leukemia. This drug has been used in other research studies and information from     those other research studies suggests that this drug may help to prevent cancer growth.      The primary purpose of this research study is to determine the highest dose of Cabozantinib     that can safely be given without severe or unmanageable side effects. The dose identified in     this study will be used in future research studies that seek to determine the role of     cabozantinib as a treatment for AML.   "
101180|NCT01961752|"     Although pain is a common complication of endoscopic submucosal dissection (ESD), management     strategies are inadequate. bupivacaine is used for visceral pain control in chronic pain and     in pain associated with surgery in clinical practice. Further, triamcinolone, a type of     steroid, is often mixed with bupivacaine to lengthen the analgesic effect. The aim of this     study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for     abdominal pain relief and as a potential method of pain control after ESD for gastric     neoplasia. We hypothesized that topical bupivacaine and/or triamcinolone acetonide injection     after ESD would be effective for pain relief. For this, we designed randomized, double-blind,     placebo-controlled trial. Eligible patients with early gastric neoplasm were randomized into     one of three groups: bupivacaine (BV) only, bupivacaine with triamcinolone (BV-TA), or     placebo. To evaluate the pain after ESD, the Present Pain Intensity (PPI) score and the     Short-Form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain at 0, 6, 12 and 24 h     after ESD.   "
101181|NCT01961739|"     The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in     the therapy of symptomatic hemorrhoids. Efficacy will be determined by:        1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general          well-being and improvement since the beginning of treatment as separate components of          CORRECTS scale        2. the change in overall CORRECTS values from baseline        3. the change in degree of hemorrhoids from baseline   "
101182|NCT01961726|"     A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde     delivery to cohorts of adults with Ischemic Heart Failure.   "
101183|NCT01961713|"     This study will evaluate a method to detect tumor cells that are circulating in the blood     without getting a biopsy. The investigators already know from other studies that cancer     tumors shed a small number of cells into the bloodstream every day. These are called     circulating tumor cells (CTCs). Some early studies indicate the amount and type of CTCs in     the blood can help determine the status of the tumor itself and the way it is responding to     treatment. In this study, the investigators will compare the number of CTCs in the blood at     different time frames before and after surgery to remove the prostate.   "
101184|NCT01961700|"     Lung cancer is one of the most common types of cancer in the world, and the cancer that     causes the most number of deaths. In Sweden, about 3700 persons are diagnosed every year.     About one fifth of the patients are eligible for surgery.      Patients undergoing thoracic surgery suffer from pain and low health related quality of life     after surgery.      In Australia, New Zealand, and the United Kingdom, pre- and postoperative physiotherapy is     routinely provided for patients undergoing thoracic surgery, but the effects have not been     thoroughly investigated. The scientific evidence of the effect of physiotherapy in connection     with lung surgery is limited. The treatment typically consists of early mobilisation,     breathing exercises and exercises for the shoulders. Reeve et al has shown that a     postoperative shoulder exercise program can improve function and decrease pain after     thoracotomy. Breathing exercises has not been found effective in reducing the rate of     postoperative pulmonary complications after thoracic surgery.      The purpose of this study is to investigate the effect of in-hospital physiotherapy     treatment, for patients undergoing thoracic surgery, on physical activity, health related     quality of life, pain and lung function.   "
101185|NCT01961687|"     Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.   "
101186|NCT01961674|"     The primary hypothesis of this study is that consumption of capsinoids increases brown     adipose tissue activity, detectable by infrared thermal imaging.      The secondary hypothesis is that consumption of capsinoids can affect an individual's     glycaemic response.   "
101187|NCT01961661|"     Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and     gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI     tracts is influenced by both genetic and environmental factors. Children with CF may harbor     an abnormal intestinal microflora, because of altered Cystic fibrosis transmembrane     conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes     and acid suppressors). The investigators previously demonstrated that intestinal inflammation     is highly frequent in CF children, being a major feature of intestinal involvement. In     addition, specific probiotics significantly improved airway and GI inflammation in a     preliminary trial. The aim of the study is to characterize intestinal and respiratory     microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG)     supplementation on both GI and airway microflora and the eventual relationship between     probiotic assumption and clinical and inflammation markers. The aim is to study the effect of     microflora modification on intestinal and extraintestinal inflammation to eventually improve     the quality of life of CF patients, who often suffer from intestinal and respiratory     progressive disease, through a non invasive intervention consisting in the supplementation of     probiotic bacteria.   "
101188|NCT01961648|"     This study is being conducted to determine whether inhaling exhaled carbon dioxide is     effective for the treatment of sleep apnea. A mild increase in this gas can stimulate the     respiratory drive by 2-3 fold, which in turn can stimulate the upper airway dilator muscles     and decrease the severity of obstructive sleep apnea by at least 50% in selected patients.   "
101189|NCT01961635|"     In patients that require a dental implant, does zirconia compared to titanium, or cad-cam     acrylic abutments, provide less inflammation, marginal bone loss or infection during the     osseointegration period ?   "
101190|NCT01961622|"     The main objective of this study is to determine whether day and night closed-loop insulin     delivery for 12 weeks under free living conditions is superior to addition of real-time     continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control     on insulin pump therapy.      This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8     week run-in period, during which glucose control will be optimised by a professional pump     educator, followed by two 3 months study periods during which glucose levels will be     controlled either by an automated closed-loop system or by subjects usual insulin pump     therapy augmented with real-time continuous glucose monitoring in random order. A total of up     to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on insulin     pump therapy will be recruited through diabetes clinics and other established methods in     participating centres. Subjects who drop out of the study within the first 6 weeks of the     first intervention arm will be replaced.      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery     system. Subjects will have regular contact with the study team during the home study phase     including 24/7 telephone support. Subjects will be discouraged from international travel     during the first two weeks of closed-loop use.      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by     CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the     HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other     CGM-based metrics.   "
101191|NCT01961609|"     This study is designed to prove and quantify the hypothesis that secukinumab is effective,     safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis     in patients who are inadequate responders to anti-TNFα therapy in a UK (and Republic of     Ireland) specific population.   "
101192|NCT01961596|"     The aim of this study is to investigate the influence of a brief application of cold (by     means of Cooling Ice Spray on the lateral ankle)on the time to stabilization of healthy     subjects.   "
101193|NCT01961583|"     Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional     and metabolic responses of biological events with specific radiotracer in vivo. The PET     tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD     (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to     αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and     mature endothelial cells but are expressed at high levels on activated endothelial cells in     the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib     acts mainly on active angiogenetic tumors, the quantitative uptake of [18F]Fluciclatide can     be used to predict the effect of this antiangiogenic drug. The investigators expected the     baseline tumor uptake in [18F]Fluciclatide to be able to predict treatment response, and     planned a study of [18F]FluciclatidePET for patients with metastatic RCC who received     pazopanib systemic therapy.   "
101194|NCT01961570|"     This study is to evaluate the performance of the Articulinx ICMC     (InterCarpoMetacarpalCushion)in the carpometacarpal joint (CMC joint) and to describe the     clinical results in patients who have been treated with this device. Expected results include     the relief of symptoms and improvement of function in patients with symptomatic     osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved     through measurements of pain, pain medication use, and joint function in up to 20 subjects.     Each subject will be compared to their pre-surgery status for each endpoint.   "
101195|NCT01961557|"     Background:      - Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch     gait, an abnormal way of walking. Knee crouch has many causes, so no single device or     approach works best for everybody. This study s adjustable brace provides many types of     walking assistance. Researchers will evaluate brace options to find the best solution for     each participant, and whether one solution works best for the group.      Objective:      - To evaluate a new brace to improve crouch gait in children with CP.      Eligibility:        -  Children 5 17 years old with CP.        -  Healthy volunteers 5 17 years old.      Design:        -  All participants will be screened with medical history and physical exam.        -  Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG          described below.        -  Participants with CP will have 6 visits.        -  Visit 1:      <TAB>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow     their movement.      <TAB>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle     activity.      <TAB>3. Participants knee movement will be tested.      <TAB>4. Participants will walk 50 meters.      <TAB>5. Participants legs will be cast to make custom braces.        -  Visit 2:        -  Participants will wear their new braces and have them adjusted.        -  Steps 1 3 will be repeated.        -  EEG: Small metal discs will be placed on the participants scalp. They record brain          waves.        -  Participants will have electrical stimulation of their knees and practice extending          them.        -  Participants will take several walks with the braces in different settings.        -  Visits 3 5: participants will repeat the walking and some other steps from visit 2.        -  Visit 6 will repeat visit 2.   "
101196|NCT01961544|"     This clinical study is designed as an open, single group, multi-center, phase 4 clinical     study to assess the safety of eribulin which is approved for the treatment of the patients in     Korea with locally advanced or metastatic breast cancer who had received two to five prior     chemotherapy regimens including anthracyclines and taxanes for advanced disease.      Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the     investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle. In     case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or     judgment by investigator that the treatment needs to be stopped, the treatment of     investigational product is stopped, and treatment termination assessment is performed within     30 days from the last treatment.   "
101197|NCT01961531|"     To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5     fraction schedule.   "
101355|NCT01959464|"     The purpose of this study is to determine if sexual intercourse lowers serum progesterone in     women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their     male sexual partners. We hypothesize, based on previous estrogen studies done by our group,     that intercourse will interfere with absorption of vaginal progesterone.   "
112164|NCT01817790|"     This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular     symptoms associated with allergic rhinitis (AR).   "
101198|NCT01961518|"     The purpose of this study is to identify patients with Morquio syndrome type A (MPS IVA) and     Maroteaux-Lamy syndrome (MPS VI) who may have been missed or misdiagnosed due to atypical     clinical features, a milder course, and/or negative urine screening. We will recruit     participants who have certain hip and/or joint problems that could potentially be caused by     one of these two genetic conditions through a chart review process conducted at Shriners     Hospital for Children in Greenville, SC. Diagnostic testing will be performed for each     participant to determine if he or she is affected by one of these two conditions. Results     will be disclosed to all participants and their legal guardians, and appropriate follow up     will be recommended for those who are found to have abnormal results.   "
101199|NCT01961505|"     Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory     disorder that may affect many synovial joints, and may cause serious disability. It has been     confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory,     immunosuppressive and cartilage protection. This is a prospective randomized controlled study     to evaluated the efficacy and safety of external application with compound Tripterygium     wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).   "
101200|NCT01961492|"     The purpose of this study is to find out whether a single fecal microbiota transplantation is     an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative     colitis.   "
101201|NCT01961479|"     The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective     in reducing the impairment caused by premenstrual symptoms.   "
101202|NCT01961466|"     This study is based on the analysis of psychological and social questionnaires filled in by     diabetic patients whose glycemic balance will be assessed by measuring blood levels of     glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic     patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile     evaluated by the Bortner self-questionnaire.   "
101203|NCT01961453|"     The purpose of this research study is to test whether treatment with isosorbide mononitrate     will improve left ventricular hypertrophy (thickening) which puts people at risk for     developing heart failure. Once it develops, heart failure is a very serious condition and     thus it is important to find ways to prevent it from happening. The investigators have     reasons to believe that dilating the blood vessels with this specific medication will improve     the thickening of the heart, which increases the risk of heart failure.   "
101204|NCT01961440|"     This research is to establish a simple and practical system to predict the prognosis of sever     hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity of     hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which were     easier to evaluate and more influential， were included to establish a prognosis scoring     system．The scorings of a new score system and MELD were graded at the same time in the     patients with sever hepatitis B. And then the distribution figures of survival rates and     mortality rates were done according to the scores from low to high. The features of     distribution figures of two score system in survival rates and mortality rates and     significances of clinical application in certain score were interpreted.   "
101205|NCT01961427|"     It was shown by some researchers that dietary nitrate such as beet root juice can lower     oxygen consumption in men and act as a performance enhancing supplement.      It was not shown, what the optimal dosage is and if there is any difference in oxygen     consumption comparing beet root juice and inorganic nitrate.      Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and     beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at     different time points and the subjects have to perform an exercise test measuring oxygen     consumption 3 hours after the ingestion of nitrate.   "
101206|NCT01961414|"     The purpose of this research study is to determine if a Treat and Extend regimen     (increasing the time between visits when the disease is stable and not getting worse) of     aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related     Macular Degeneration.   "
101207|NCT01961401|"     Exercise training is recognized as effective in preventing and treating many chronic     metabolic disorders (1), and long-term exercise programmes have similar effects on glucose     control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise     intensity and volume of aerobic exercise needed to produce the most wanted effects on     targeted risk factors for subjects at risk of/with established type 2 diabetes, is still     uncertain. In this study the investigators will investigate the acute effects of a single     bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with     and without gestational diabetes mellitus (GDM). The investigators think that very short     bouts of high intensity exercise can be a way to reduce blood glucose in these women.   "
101208|NCT01961388|"     The study is designed as non interventional to collect data on the effectiveness of acarbose     and metformin monotherapy, respectively, in terms of change from baseline in post prandial     blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each     carbohydrates consumption subgroup under real-life treatment condition in large sample of     type-2 diabetes patients in India. The study will begin after the study approval by ethics     committee.All drug naïve patients in whom decision to administer acarbose or metformin     monotherapy for type 2 diabetes management has been made will be included in study after     taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study     involves general examination of patients, collection of data like history of disease,     concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll     12250 subjects from multiple study centers spread across India. The study data will be     analyzed with appropriate statistical methods.   "
101209|NCT01961375|"     The study is designed as non interventional to observe the continuation rate and the patient     satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system)     inserted for contraception over the period of 12 months under real life condition in     India.The study will begin after the study approval by ethics committee.All Indian women aged     between 18-49 years who are initiating LNG IUS therapy for contraception will be included in     study after taking the informed consent.Patients will be observed for upto 12 months.The     study involves general examination of patients, collection of data like medical history,     previous contraceptive use,concomitant medication etc.The study is planned to enroll 600     subjects from multiple study centers spread across India. The study data will be analyzed     with appropriate statistical methods.   "
101212|NCT01961336|"     Ιt has been suggested that the accumulation of androgens in the micro milieu of the primate     ovary, plays a critical role in early follicular development and granulosa cell     proliferation. Increased intraovarian concentration of androgens seems to augment follicle     stimulating hormone (FSH) receptor expression in granulosa cells and thus, potentially     leading to enhanced responsiveness of ovaries to FSH. In addition, androgen excess has been     shown to stimulate early stages of follicular growth and increase the number of pre-antral     and antral follicles.      On the basis of these data, it has been hypothesized that increasing androgen concentration     in the ovarian micro milieu in poorly responding patients might lead to an increase in the     number and the maturity of oocytes after ovarian stimulation for IVF. Hence, recent efforts     have been focused on the potential benefit of androgen administration in the probability of     pregnancy in poor responders undergoing ovarian stimulation for IVF.      Pretreatment with transdermal testosterone has been suggested as a safe and effective way of     increasing the intraovarian androgen concentration. Recently, published, randomized control     trials (RCTs) have evaluated transdermal testosterone in poor responders undergoing ovarian     stimulation for IVF, with inconclusive results.      In view of the conflicting or inconclusive data regarding the efficacy of the proposed     intervention, this study will attempt to explore the role of transdermal testosterone     pretreatment in poor responders undergoing IVF through a properly designed RCT. The lack of a     universal definition of poor responders has been identified previously and recently, in an     attempt to address this issue, universal criteria for the definition of poor ovarian response     have been proposed following a consensus meeting in Bologna. In the present study, the     Bologna criteria will be used on the contrary to previous studies.      Despite the advancement in assisted reproduction technologies, poor ovarian response (POR) is     still considered to be one of the most challenging tasks in reproductive medicine. Poor     ovarian response is considered to be an inadequate response to ovarian stimulation, defined     usually by a low number of oocytes retrieved or a low number of developing follicles in a     previous or in the running, respectively, in vitro fertilization (IVF) cycle. Given the     severely diminished probability of pregnancy after IVF in these patients, the identification     of an indisputably efficacious treatment, such as testosterone pretreatment, would be a     promising alternative for poor responders undergoing IVF.   "
101213|NCT01961323|"     To investigate whether treatment with Nebivolol in subjects with high blood pressure and     abnormal filling of left ventricle (LVDD) improves exercise time by improving Left     Ventricular deformation and filling.   "
101214|NCT01961310|"     The main objective of this study is to compare the intestinal microbiota in newly diagnosed     rheumatoid arthritis (RA) with that from individuals without RA.      The first analysis will compare the proportion of filamentous bacteria in the intestinal     microbiota between the two groups.   "
101215|NCT01961297|"     The proposed research aims to determine brain abnormalities in patients with spasmodic     dysphonia (SD) and voice tremor (VT) as the basis for characterization of central mechanisms     underlying symptom improvement following the use of sodium oxybate, a novel oral medication     for the treatment of ethanol-responsive dystonia. The proposed research is relevant to public     health because the elucidation of disorder-specific mechanistic aspects of brain organization     in SD vs. SD/VT is ultimately expected to lead to establishment of enhanced criteria for     clinical management of these disorders, including differential diagnosis and treatment. Thus,     the proposed research is relevant to the part of NIH's mission that pertains to developing     fundamental knowledge that will help to reduce the burdens of human disability.   "
101216|NCT01961284|"     Dental implants are used for replacing missing teeth. Placing dental implants is limited by     the presence of adequate bone volume permitting their anchorage. In order to solve this     problem several bone augmentation procedures have been developed. In principle the missing     bone is taken from a donor site (for example the hip), transplanted where needed and then     implants are placed. Sometimes, major bone grafting operations have to be undertaken under     general anaesthesia requiring patients to be hospitalised for a few days. Some degree of     morbidity related to the donor site must be expected, though more recently bone substitutes     are used to minimize morbidity, and 2 to 3 surgical interventions may be needed before the     implants can be functionally used. Sometimes patients have to wait more than 1 year before a     prosthesis can be fixed to the implants and the total cost of the treatment is high. At the     beginning of the 1990s a long screwshaped implant was developed by Professor PI Brånemark as     an alternative to bone augmentation procedures: the zygomatic implant. Zygomatic implants are     generally inserted through the palate to engage the body of the cheek bone. One to three     zygomatic implants can be inserted through the posterior palate to engage the body of each     cheek bone. The potential main advantages of zygomatic implants could be that bone grafting     may not be needed and a fixed prosthesis could be fitted the same day of their placement.     Despite that zygomatic implants have been used for more than 20 years, their effectiveness     has never been compared with conventional dental implants in augmented maxillae. The aim of     the project is to compare the longtermclinical outcome of fullarch upper jaw bridges     supported by zygomatic implants versus conventional implants placed in augmented bone in the     palate.   "
101217|NCT01961271|"     The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch     (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of     moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and     joint/muscle pain, who are not adequately responding to non-opioid painkillers.   "
101218|NCT01961258|"     SEVERE ASTHMA IN THE COMMUNITY-      BACKGROUND Severe asthma is a common problem. In the world approximately 300 million people     have asthma but it is estimated that only 5% of these patients have severe asthma. Although     severe asthma comprises a small fraction of the entire asthmatic population its share in     the total economic burden of asthma is 80 percent. In Israel the prevalence of asthma among     adult patients is about 5-6% but the prevalence of severe asthma is unknown.      The definition of severe asthma has been changed during the years. Most recently in 2009 the     WHO agreed on a unified definition of severe asthma that would fit countries of different     socioeconomic development [1]. Severe asthma includes now 3 different groups: group one     untreated severe asthma, group two difficult to treat severe asthma and group three     treatment-resistant severe asthma. As all asthmatic patients in Israel have easy access to     medical care, the current study will deal with the last two groups (difficult to treat     asthma and treatment resistant asthma).      AIMS Primary endpoints:        1. To identify the prevalence of severe asthma in the community according to the WHO          definition of group two & three.        2. To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of          severe asthma.      Secondary endpoints:        1. To assess factors involved in difficult to treat asthma according to the WHO          definition. Factors as patient compliance, presence of co-morbidities, symptoms of          untreated potential asthma triggers including GE reflux, post nasal drip/atopic          rhino-sinusitis, and intervening medications including NSAID and beta-blockers.        2. To asses the level of asthma control, level of patient follow-up care including asthma          specialist visits, periodic PFT's and asthma education.        3. To assess the fraction of patients with severe asthma that is eligible to anti-IgE          therapy according to the indications of the Israeli Ministry of Health (proven asthma,          uncontrolled by high dose of combined ICS+LABA inhaler therapy + at least 2 courses of          systemic corticosteroids in the last year + proven atopy to at least one perennial          aeroallergen + IgE level of 30-1,500 IU/ml)      DESIGN A prospective non-blinded non-randomized observation study among the population     insured by Clalit Medical Services (CMS) in the Sharon- Shomron Medical District in Israel.   "
101236|NCT01961024|"     In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2     diabetic and healthy subjects matched for BMI in order to elucidate the potential     pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in     abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of     fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal     muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes     that might be involved in regulating skeletal muscle and adipose tissue FA storage.   "
101219|NCT01961245|"     It has been shown, that in patients with very severe chronic obstructive pulmonary disease     (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR)     may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques     provides a better recovery of the respiratory pump during the night. If non-invasive     ventilation also decreases the metabolic demands during night is unknown and is aim of this     study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with     chronic obstructive pulmonary disease stage IV will be recruited for this study. There will     be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a     non-invasive ventilation will be involved in the intervention group where non-invasive     ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage     IV without an indication for the use of non-invasive ventilation will be involved in a     control group to detect the changes in nocturnal energy expenditure produced by pulmonary     rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be     repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the     pulmonary rehabilitation program.      A sub-trial of this study is to validate night movement accuracy of the Dynaport activity     monitor with the observations made by a night-vision camera in the sleep lab. This will be     performed in study participants as well as in healthy volunteers.   "
101220|NCT01961232|"     The investigators are testing whether the addition of Pulmonary Hypertension-related     biomarkers, measured across the pulmonary circulation, to the standard hemodynamic evaluation     for Pulmonary Hypertension will lead to more informed choices of Pulmonary Hypertension     therapy and improved patient outcomes.   "
101221|NCT01961219|"     Shoulder pain is one of the most common causes of musculoskeletal disability in the adult     population. Adhesive capsulitis is one of a multitude of reasons that can cause shoulder pain     and dysfunction. It is a painful and disabling condition that can cause frustration for     patients and caregivers due to slow recovery time. It is important to meticulously diagnose     the source of the symptoms. Adhesive capsulitis is treatment by non-operative therapies such     as physical therapy, exercise, steroids & pain medications. For some patients a quicker     return to function is necessary; in th is situation an operative treatment is an option. This     study will compare two surgical techniques for adhesive capsulitis.      Purpose        1. To directly compare outcomes of patients with adhesive capsulitis who have failed pain          management and failed improvement in range of motion after at least 3 months of          supervised, regimented conservative treatment and have subsequently been randomized to          either closed manipulation under anesthesia or arthroscopic capsular release.        2. To blind both patient and assessing physician/nurse study coordinator to the treatment          that was received for the duration of the study. This will reduce the effect of any          potential bias on the results as much as possible.        3. To collect outcome data, both subjectively from the patient using proven outcome          measures, and objectively from regularly spaced follow up visits with blinded assessors.        4. To collect and comment on data from the two treatment groups regarding duration of          post-operative narcotic use, duration of post-operative physical therapy required,          post-operative pain levels, and elapsed time until back to work/activity          post-operatively.   "
101222|NCT01961206|"     Escherichia coli is the leading cause of community-onset gram-negative bloodstream     infections. There has been a dramatic increase in the prevalence of extended-spectrum     b-lactamases producing E. coli and K.pneumoniae in the community, which was considered to be     exclusively a nosocomial pathogen in recent years. As a result, the treatment options for     community-onset infections due to ESBL-producing E. coli or K.pneumoniae are limited and the     initial empirical therapy is often ineffective and associated with increased mortality.     Although there were some reports of the risk factors of community-onset ESBL producing E.     coli in Spain, Korea, and Canada, few empirical data were available about China. Therefore,     the investigators aim was to investigate the epidemiology, risk factors, and the hospital     outcomes for patients with community-onset bacteremia caused by ESBL producing E. coli or     K.pneumoniae in China.   "
101223|NCT01961193|"     Study Rationale:      The insertion of a bandage contact lens or punctal plug in a defined group of patients     admitted to the ICU may be more effective than standard care in decreasing the incidence of     corneal injuries.      Study Objectives:        1. To document the effect of a contact bandage lens and punctal plug in preventing corneal          injuries in critically ill patients admitted to the ICU.        2. To assess the safety of a contact bandage lens and punctal plug in critically ill          patients.   "
101224|NCT01961180|"     Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose     metabolism, physical and mental health and quality of life in polycystic ovary     syndrome(PCOS).      Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.   "
101225|NCT01961167|"     The primary objective of the GORE® PI-13-05 clinical study is to evaluate the safety and     efficacy of PI 13-05 for the treatment of arterial occlusive disease in patients with de novo     or restenotic lesions in the common and/or external iliac arteries.   "
101226|NCT01961154|"     Background:      The most common asthma drugs, namely inhaled glucocorticoids (ICS) and long-acting beta-2     sympathomimetic drugs (LABA) carry a risk of adverse effects, some of which being potentially     severe. Therefore, current guidelines for asthma management recommend that, after a period of     symptom control, a reduction of the dose and cessation of the ICSs and LABAs should be     attempted. However, reduction in asthma medications sometimes leads to an exacerbation of     asthma. Therefore both physicians and asthmatics are often reluctant to reduce or stop asthma     medications and asthma over-medication often occurs. A test that could identify those     asthmatics who probably would tolerate asthma medication reduction would be useful.      Objectives:        1. To investigate whether airway responsiveness to hypertonic saline can predict the          outcome of asthma treatment reduction in subjects with controlled asthma.        2. To get an estimate about how large a proportion of Finnish asthmatic patients use their          medications with unnecessarily high doses or would even manage well without any asthma          medications.      Study hypothesis:        1. Airway responsiveness to hypertonic saline can predict the outcome of asthma treatment          reduction        2. Most of the Finnish asthmatic patients use their medications with unnecessarily high          doses      Methods:      This is a prospective study in which the physician responsible for the subject management and     medications is blinded from the saline challenge results and the nurse performing the saline     challenges is blinded from medications 70 asthmatic patients with both inhaled ICS and LABA     will be recruited. Asthma must be well controlled (Juniper's Asthma Control Questionnaire     score equal or less than 0.75 ).      The asthma medications will be reduced in three steps, in six weeks' intervals, up to total     cessation of asthma drugs or up to asthma exacerbation. The criteria for asthma exacerbation     are strictly defined. First step: LABA will be discontinued. The ICS is continued. Second     step: medium to high daily ICS dose is reduced to low daily dose. Third step: The low ICS     dose will be stopped. Before each reduction, saline challenge will be performed. Asthma diary     is kept throughout the study and the subjects will be provided a direct telephone number to a     respiratory physician during all hours of day.   "
112190|NCT01817452|"     Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without     chemotherapy backbone within the ADAPT trial.   "
101227|NCT01961141|"     Historically, ultrasound has been unable to provide interpretable data from the lung     parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by     the air in the lungs. Recently it has been shown that clear reproducible Doppler signals can     be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system     incorporating a special signal processing package (transthoracic parametric Doppler, TPD,     EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with     the cardiac cycle and can be obtained from the lungs, including areas remote from the heart     and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and     are of relatively high power, making it possible to detect them despite the aforementioned     attenuation by the air in the lungs. The LDS are thought to represent the radial wall     movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin     which propagate throughout the lung vasculature. The LDS may contain information of     significant diagnostic and physiological value regarding the pulmonary parenchyma and     vasculature, as well as the cardio-vascular system in general.      Preliminary data from ongoing studies employing the TPD in chronic diseases such as CHF, COPD     and pulmonary hypertension, show promise regarding the diagnostic potential of the lung     Doppler signals (unpublished data). However, lung Doppler signals in acute disease states     were not investigated so far. It is reasonable to speculate that the pathological processes     underlying acute cardiovascular and pulmonary diseases will affect the LDS. Therefore, the     TPD may have diagnostic potential in these conditions. For example, during acute pulmonary     embolism a portion of the pulmonary vascular system is occluded; therefore it's reasonable to     assume that the LDS will disappear in the affected area, enabling to confirm the diagnosis     without using ionizing radiation (as in CT or lung scan). Another example is COPD     exacerbation, during which there is usually air trapping in the lungs; thus, the LDS may be     attenuated by the increase of air volume in the lungs.   "
101228|NCT01961128|"     This study is being done to see if the investigators can measure changes that occur in breast     tissue when women at risk of developing breast cancer start an exercise program. The     investigators are interested in studying this because research shows that women who exercise     regularly are less likely to develop breast cancer, but there is not very much information     explaining how exercise could affect breast cells in a way to prevent cancer from occurring.     In this research study the investigators will use a research technique called breast random     fine needle aspiration (RPFNA) to test breast cells for their shape and how they look. The     investigators will look at breast cells before and after a participant takes part in an     exercise program to see if the investigators are able to see any changes in breast cells that     could have happened due to the exercise program. This research will help us to develop larger     projects to see if exercise programs could be helpful in preventing breast cancer.   "
101229|NCT01961115|"     This pilot phase II trial studies how well epacadostat and vaccine therapy work in treating     patients with stage III-IV melanoma. Epacadostat may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Vaccines made from peptides and antigens     may help the body build an effective immune response to kill tumor cells. Giving epacadostat     with vaccine therapy may be an effective treatment for advanced melanoma.   "
101230|NCT01961102|"     It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and     intraoperative rapid section a positive predictive value (PPV) regarding the objective     illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative     predictive value (NPV) of 99%.   "
101231|NCT01961089|"     Study question: How does the new GALILEI Lens Professional compare to predicate devices?     Study hypothesis: The GALILEI Lens Professional achieves a better precision in the     postoperative, calculated target refraction with cataract surgeries than predicate devices,     and it is more versatile in the measurable parameters as well as more user-friendly.   "
101232|NCT01961076|"     In this clinical cross-over study, we will compare the efficacy of different oral nutrition     regimens for night-time glucose control in adult GSD 1 patients. Three different over-night     nutrition regimens (=interventions) will be compared in each patient sequentially, (1)     uncooked corn starch (UCSS, Maizena), (2) modified corn-starch, (3) other carbohydrate     (starch) containing meal. During each intervention, glucose profiles will be continuously     monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d     (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the     technical quality of glucose sensor readings. Between the interventions, the patients follow     their normal prescribed diet.   "
101233|NCT01961063|"     This pilot clinical trial studies gene therapy after frontline chemotherapy in treating     patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma (NHL).     Placing genes for anti-human immunodeficiency virus (HIV) ribonucleic acid (RNA) into     stem/progenitor cells may make the body build an immune response to AIDS. Giving the     chemotherapy drug busulfan before gene therapy can help gene-modified cells engraft and work     better.   "
101234|NCT01961050|"     The purpose of this study is to evaluate an intervention aimed at reducing risk for     alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian     children. The study will determine whether physicians, trained in a dual-focused brief     motivational intervention and monitored for performance, can foster greater change in     knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women     who are at risk than standard care.   "
101235|NCT01961037|"     Falls are the leading cause of death and injuries in adults over age 65 both nationally and     in West Virginia. Rurality, age, physical inactivity, and chronic conditions, such as     arthritis, are strong risk factors for falls in this population. West Virginia has a higher     than average fall rate, the second oldest population, the greatest proportion of inactive     adults, and the second highest prevalence of arthritis in the US. Thus, older adults in rural     West Virginia are at high risk for falls and in great need of public health fall prevention     programs. The Tai Chi: Moving for Better Balance (MFBB) program is a community-based,     fall-prevention exercise program for older adults. A waiver of informed consent will be     requested to conduct the telephone screenings to determine study eligibility. We will enroll     up to 300 people in classes to be held at 20 churches in West Virginia. Classes will be held     twice per week for 16 weeks and taught by certified MFBB instructors. Participants will be     interviewed by telephone, have a brief physical function ability exam, and complete a     questionnaire before starting the exercise class, at the end of the class, and 4 months     later. The study is being conducted to answer the following questions: 1) What are the     functional improvements of older adults who participate in a 16-week MFBB program; 2) What is     the rate of falls for those adults; 3) What is the rate and severity of those fall-related     injuries of the MFBB participants? The purpose of the study is to: 1) implement a 16-week     intervention of MFBB with a 16-week follow-up, in older adults in churches in rural West     Virginia; 2) describe functional and fall/injury outcomes. Ultimately, we will translate an     efficacious and effective fall-prevention intervention into a new setting.   "
132484|NCT01550861|"     The objectives of this study are to evaluate the clinical efficacy of Natural in vitro     Fertilization and in vitro maturation.   "
101237|NCT01961011|"     Carpal tunnel release is a well accepted treatment for median nerve compression at the wrist.     With a prevalence of 50 per 1000, it is the most common compressive neuropathy. With a number     of anatomic as well as systemic factors playing a role in the development of carpal tunnel     syndrome, it is not surprising that there is a high incidence of bilaterality with this     disease. Padua et al. reported that 87% of 266 consecutive cases had signs and symptoms of     carpal tunnel syndrome in their contralateral hand.      In patients who have bilateral carpal tunnel syndrome that has not responded to conservative     treatment, surgical release is indicated. In such cases, a decision must be made whether to     offer bilateral simultaneous surgical release or to stage the two affected hands to allow     time to recover from each.      The purpose of this study is to determine the differences in short term disability between     having bilateral vs unilateral carpal tunnel release. With better understanding of the way in     which patients are impaired, better recommendations may be made on which patients to indicate     for simultaneous bilateral procedures and who would benefit from staging procedures, allowing     the patient to recover from one hand prior to proceeding to surgery on the other hand.   "
101238|NCT01960998|"     Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but     pelvic floor muscle training and exercise (including urine control strategies) have been     shown to reduce the time to regaining urine control. This study tests an evidence-based,     pelvic floor muscle training program that has been adapted to telehealth format and pilot     tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery     and continued 6 months after surgery. Content is accessed on a secure website in daily     10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the     investigators' pilot study, Veterans reported that they appreciated receiving the training in     the privacy of their homes, enjoyed the interactive style of the learning experience, and     felt better prepared to deal with urine leakage and empowered with new knowledge and skills     to help themselves. Content for both control and treatment groups includes general     information about prostate cancer; perioperative care; wetness, odor and skin care     management. The treatment group will ALSO receive pelvic floor muscle training and bladder     control strategies. Outcomes are measured with brief validated questions administered by the     telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth     platform.   "
101239|NCT01960985|"     Verifying the efficiency of motor training associated with visual and auditory cues on the     balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's     Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized     clinical trial performed at Center of Research of the courses of Speech Therapy, Physical     Therapy and Occupational Therapy of São Paulo University.   "
101240|NCT01960972|"     This protocol aims to implement, using a stepped wedge trial design, a population-level     intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium     salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban     area of Tumbes.      We hypothesize that participants aged 18 years and over from villages receiving a salt     substitute will have lower blood pressure compared to control villages.   "
101241|NCT01960946|"     This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood     pressure. MCP is a dietary supplement that is derived from plants, and therefore is not     subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been     deemed as 'generally regarded as safe' by the FDA.      This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood     pressure. The study will help understand how MCP may affect the risk for heart disease in     patients with high blood pressure.   "
101242|NCT01960933|"     In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute     angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel     disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to     provide evidence as to whether full revascularization or revascularization of the culprit     lesion only provides the best prognosis for the patient.   "
101243|NCT01960920|"     Exposure to air pollution is associated with increase in cardiovascular morbidity and     mortality. Controlled human exposure studies have demonstrated impaired vascular function and     heart rate variability on healthy volunteers. The aim of this study is to investigate the     effects of reducting diesel exhaust inhalation on endothelial function, heart rate     variability and cardiopulmonary stress testing in healthy volunteers and patients with     chronic heart failure, by using a filter mask.   "
101244|NCT01960907|"     The CHROMED project focuses its investigation on the applicability of an integrated solution     for a pathological condition which: a) is very prevalent in ageing patients and b) severely     impairs quality of life: COPD with other typical comorbidities such as congestive heart     failure and sleep disordered breathing. A specific ICT platform in combination with a set of     innovative devices will be used to collect and process useful clinical data at the patient's     home and used to optimize their medical treatment. To evaluate the impact of this solution,     an international multi-centric randomized control trial will be implemented in five European     regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social     and organizational contexts in Europe.   "
101245|NCT01960894|"     If the heart fails to pump a sufficient amount of blood, it is crucial to know why in order     to provide the best treatment. Pressure-volume analysis is the gold standard for evaluating     the heart's pumping function. Unfortunately, current techniques are invasive, so most     patients will not get this examination. By combining the strengths of echo-Doppler     ultrasound, blood pressure monitoring and biomedical computing, the investigators aim to     develop a non-invasive method for pressure-volume analysis, extending its applicability to     more patients and settings.   "
101246|NCT01960881|"     Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients     Managed with Lupron.   "
101356|NCT01959451|"     This study investigates whether a platelet function testing guided approach with a short-term     (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate     responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and     thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary     syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).   "
113128|NCT01805180|"     The purpose of this study is to compare the procedures for the collection PMN cells on Terumo     BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.   "
101247|NCT01960868|"     Liver transplantation is the last surgical treatment for patients with acute or chronic liver     disease. Transplantation therapies technics are in constant evolution. It allows an     increasing survivals rates and time to come back to daily activities. The postoperative     treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in     Intensive Care Unit (ICU).This postoperative phase is one of the most important steps     regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical     abilities transplantation are likely to be important in the postoperative. It appears that     pre-transplant subjects have a weakened muscle potential, they will increase it significantly     in the months after transplantation with a rehabilitation program adapted (Beyer 1999).     Length of stay in ICU depends on surgery complications. Inactivity induced by sedation and     ICU length of stay are major factor for increasing complications as respiratory disorders and     muscle weakness. Several studies have reported feasibility and safety an early mobility     program in ICU, especially regarding the length of stay decrease (Bailey 2007; Morris 2008;     Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs encompass muscle     strength assessment, passive range of motion, active mobility, sitting on the edge of bed,     standing and walking, which would be related to the primary disease of LT (Rongies 2008). The     assessment of the strength for ICU patient is feasible and reproducible with the Medical     Research Council score (MRC score). The MRC score consists in an assessment of three muscle     groups of upper and lower limbs. Sitting positions and verticalization are included in     programs begun as soon as possible after surgery evaluation of the response level to verbal     stimulation and physical abilities (Gosselink 2011). The skills of the physiotherapist are     established in legal texts making him a key in the assessment and management of these     patients on musculoskeletal and respiratory domains.      The purpose of this study is to validate data feasibility and tolerance. Another aim is also     to assess the length of stay in ICU, of early mobility and physical program, started in the     postoperative period in a population of patients with liver transplantation, during their     stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open,     randomized monocentric comparing two groups of patient liver transplanted. The control group     will receive the standard treatment used in the ICU and the experimental group will receive a     protocol of early mobilization according to data from recent literature on the subject. The     study is scheduled to last over one year and included patients will receive physical therapy     on five days a week with a frequency of one to several times per day depending on the     clinical requirements or conditions of the study.   "
101248|NCT01960855|"     This is a multi center, randomized, double-blind, placebo-controlled phase 2 study in     subjects with moderately to severely active rheumatoid arthritis on background methotrexate     who have failed anti-Tumor Necrosis Factor (TNF) biologic therapy.   "
101249|NCT01960842|"     The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with     advanced Parkinson's disease.   "
101250|NCT01960829|"     This is a single-armed, open-labeled and single-centered study of everolimus in selective     patients with metastatic melanoma for evaluation of the efficacy and safety. The study     objective is to evaluate efficacy profile of everolimus.      The patients who comply with the inclusion and exclusion criteria will be enrolled. The     estimated recruiting duration is 18 months. Everolimus will be given in the dose of 10 mg     orally each day at lease 6 months unless disease progression or intolerance. The follow-up is     till death(at least 1 year).   "
101251|NCT01960816|"     Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing   "
101252|NCT01960803|"     The overall objective of this study is to determine the feasibility and tolerability of     single dose Intraoperative Electron Radiation Treatment (IOERT) as definitive therapy when     administered at the time of breast conserving surgery for patients with early stage breast     cancer.   "
101253|NCT01960790|"     This investigation will be conducted to obtain the following information regarding the use of     Adalimumab 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's     Disease.        1. Incidence and conditions of occurrence of adverse reactions in clinical practice        2. Factors likely to affect the safety and effectiveness   "
101254|NCT01960777|"     The objective of this study is to evaluate chronic pain after inguinal hernia repair     involving mesh placement with the Onstep-technique compared to mesh placement using a     laparoscopic approach. The study hypothesis is that an even or smaller proportions of     patients operated the Onstep technique will have chronic pain that impairs daily function.   "
101255|NCT01960764|"     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of     S. aureus skin infections. In addition, research in the investigator's lab has shown that     these patients have fewer protective antimicrobial Staphylococcal species such as     Staphylococcal epidermidis (S. epidermidis) known to produce antimicrobial peptides that play     a role in protecting the skin from invading pathogens. In this study, the investigator will     attempt to decrease S. aureus colonization and increase colonization by protective Staph     species. First the investigator will culture the bacteria on subjects' lesional AD skin. The     investigator will selectively grow the subject's antimicrobial Staph colonies and place them     into a base moisturizer. The moisturizer plus bacteria will be applied to both of the     subject's arms. Prior to applying this, though, one arm will first be pre-treated with an     antimicrobial regiment of Dial liquid antibacterial soap and alcohol. We will then compare     the abundance of antimicrobial Staph species on each subject's arms 24 hours later to     determine whether the pre-treatment regimen increased survival of the transplanted     antimicrobial Staph species. The investigator expects that the arm pre-treated with the     antimicrobial regimen will have more antimicrobial Staph species at this time point.   "
101256|NCT01960751|"     Context: Studies that address specifically the neurocognitive consequences that can be caused     by low-dose radiation receiving during the childhood have still to be performed. In this     issue, we focus on an investigation with patients who have received radiotherapy for a benign     tumor (skin hemangioma), in France.      Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave     Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy.     These patients have been treated and followed by Gustave Roussy, so their clinical records     can be tracked with great accuracy and the ionizing radiation dose to the brain have been     estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or     disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A     total of 150 patients is expected. They will be contacted by letter to explain the purpose     and methods of carrying out tests. Two groups will be analysed according to the received     ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs     unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory,     arithmetic, orientation, etc.) will be used.      Expected results: We expect to describe the potential neurocognitive dysfunction or disorder     and to identify risk factors and brain structures whose lesions are responsible for the     neurocognitive dysfunction or disorder.      A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive     dysfunction or disorder.   "
101257|NCT01960738|"     To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving     mishaps in recreational divers.   "
101258|NCT01960725|"     This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus     vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2     months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of     age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4     month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to     the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from     subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus     IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P[8]     serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will     be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the     alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2,     G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared between children receiving     RV5 according to the alternate dosing schedule and the standard recommended schedule. The     safety and tolerability of RV5 in children receiving vaccine according to the alternate     dosing schedule will be described.   "
101259|NCT01960712|"     Bile leakage after liver transection is treated by external drainage. The question addressed     is whether downstream control by transpapillary stent insertion into distal bile duct can     enhance healing.   "
101260|NCT01960699|"     Background: Cardiac arrest is a life-threatening event. Intensivists are challenged with an     increasing number of patients with uncertain neurological outcome following cardiopulmonary     resuscitation (CPR). The prognostic value of current biomarkers for neurophysiologic     long-term outcome is limited.      Hypothesis: We hypothesize that specific brain-derived tissue leakage proteins can be     identified to reveal novel, more reliable prognostic biomarkers for good neurological     outcome.      Methods: This translational study (n=100) is a combination of a prospective basic science     study intended to reduce the number of potential plasma biomarker candidates by proteomic     shotgun analyses in brain tissue autopsy samples and plasma samples from resuscitated     patients (n=10) and a prospective clinical validation study in a large study population     (n=100) by high-throughput analyses. Selection of proteomic markers and signature estimation     will be performed to discriminate patients with good and poor outcome.      Clinical perspective: A structured proteomic analysis approach might identify the best marker     out of all proteins liberated during cellular damage.   "
101261|NCT01960686|"     The purpose of this study is to evaluate the immunogenicity and safety of multiple     formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of     child-bearing age.   "
101262|NCT01960673|"     Generally, the laryngeal mask airway is not considered in the surgery which should be     changing position in the perioperative period. The shape of the pharynx changes during the     head and neck movement and there is probably also a change in the force transmitted to the     cuff along the airway tube. Besides, there is evidence that supraglottic airway device can be     displaced with rotation. In this article, the investigators want to discuss about that     oropharyngeal leak pressure and sealing between the mask and vocal cord while changing head     and neck position in perioperative period using different types of supraglottic airway     device.   "
101263|NCT01960660|"     Supplementation with omega-3 fatty acids has been extensively researched and is known to     provide healthful benefits for patients with a diversity of conditions and diseases. Not all     omega-3 supplements are created equally however; some sources of omega-3 fatty acids are     superior to others due to a greater bioavailability of omega-3 fatty acids than others,     differences in source material, and processing techniques.      The purpose of this study is to determine which marketed omega-3 product provided the     greatest effect, as measured against its' label claim and recommended dosage.   "
101264|NCT01960647|"     The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is     to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous     transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo     occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.   "
101265|NCT01960634|"     This is a multi-centric translational study with biological samples collection. The aim of     this study is to validate a method to detect BRAFV600 in blood samples.      Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard     medical practice.      The treatment is not the aim of the study. Patients can be treated either with specific or     no-specific drug.   "
101266|NCT01960621|"     The investigators want to see whether the test drug in this research study,     2-hydroxypropyl-beta-cyclodextrin (2HPBCD), might potentially be able to improve cough in     healthy volunteers. The investigators are initially recruiting healthy volunteers such as who     are free from any respiratory disease and not on any concurrent medication, so there are no     confusing effects from pre-existing respiratory symptoms or disease, nor interaction of any     medication with the test drug.   "
101267|NCT01960608|"     Increasing sodium intake raises blood pressure. And high salt intake could hinder the     management of chronic disease. Much previous research has confirmed that dietary habits are     affected by economic status. So we compared sodium intake with economic status. We     investigated the prevalence, extent and management, and the relevance of sodium intake with     income level.   "
101268|NCT01960595|"     The purpose of this study is to investigate the efficacy and cost analysis of intravenous     fentanyl combined with either local anesthesia infiltration or peroneal nerves block in     patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with     patients without local anesthetics administration perioperatively.   "
101278|NCT01960465|"     Obstructive sleep apnea (OSA) is a major public health problem in the U.S. and more than 35%     of Veterans are at high risk for OSA. OSA is associated with progression of hypertension, an     important health problem in Veterans. African Americans with OSA are at increased risk for     poorly controlled hypertension and its health consequences. Implementing a care plan to     increase the percentage of Veterans in whom blood pressure goals are achieved has been     prioritized by Veterans Administration hospitals. Recent studies show that hypertension     control can be improved with continuous positive airway pressure (CPAP) treatment of OSA. The     aim of this proposal is to examine and compare the effects of CPAP treatment on 24-hour     arterial blood pressure and central aortic blood pressure (measured non-invasively with a     cuff on the upper arm) in African American and other Veterans.   "
101269|NCT01960582|"     The rationale underlying this project is the fact that HA is a very common compensatory     interven¬tion within municipality health care, undertaken to support an independent living in     the own home. In addition, MD are frequently prescribed and used among HA clients in order to     compensate for declined body functions. In spite of this, knowledge of their effects for the     individual and the society is still scarce. In particular, systematic, evidence-based     strategies based on clear-cut conceptual definitions and descriptions of procedures are     lacking. Such strategies are crucial in order to evaluate the effects of HA and MD. In     addition, longterm cost-effectiveness evaluations are crucial for policy implementation.      The overarching aim is to investigate outcomes of HA on aspects of home and health for     sub-groups of persons with disabilities.      The specific aims are to:        -  Investigate the effects of HA on home and health related outcomes, i.e. usability, fear          of falling, activity/participation and health-related quality of life for different          subgroups of persons, e.g. MD users and non MD-users        -  Investigate the use of a new practice strategy for HA on home and health related          outcomes for subgroups of persons with disabilities in terms of differences between          municipalities        -  Investigate societal level outcomes of HA and MD, i.e. costs and quality adjusted life          years        -  Gain a deeper understanding of the processes behind changes in outcomes We hypothesise          that using a structure strategy for housing adaptation and mobility devices case          management in ordinary practice in Swedish municipalities increase activity,          participation, the usability of the home, and reduces societal costs.   "
101270|NCT01960569|"     Single centre ,Phase IV , interventional, The study includes :      200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have     placebo .      The patients will be randomized to the active product (arm 1) or to placebo (arm 2).      The study consists of 4 visits as the following :        -  Visit 1 : on day 1 to check patient eligibility and also for randomization .        -  Visit 2 : on day 4 to assess target parameters        -  Visit 3 : on day 8 to assess target parameters        -  Visit 4 : on day 16 to assess target parameters   "
101271|NCT01960556|"     Catheter associated blood stream infections (CA-BSI) remain a source of significant morbidity     and mortality in adult and pediatric critical care units. While it has been established that     CVL maintenance bundles are pivotal to achieving and maintaining low CA-BSI rates, training     and retention of proper bundle compliance remains a challenge.      The investigators prospectively compared this simulation-based program to a standard     educational approach.      The investigators hypothesized that implementation of bedside simulation-based training of     CVL dressing changes by registered nurses would improve CVL maintenance bundle compliance.   "
101272|NCT01960543|"     Elderly patients with hip fracture are frail due to associated comorbidity. In these     situations, regional anesthesia is recommended as it is associated to less postoperative     cognitive dysfunction. However, hypotension during the process may impair ischemic     cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and     the administration of vasoactive drugs during the process can minimize these risks. Although     bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the     studies show conflicting results. The aim of this study is to investigate if there are     clinically relevant differences between these two drugs in terms of hemodynamic parameters     during the surgical process with special focus on the effects on regional cerebral oximetry     and cognitive status after surgery.   "
101273|NCT01960530|"     This study will investigate a new drug called Infacort®; a newly-developed immediate release     formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a     replacement treatment for people whose adrenal glands are not producing enough natural     cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort®     acts once inside the body, by measuring cortisol and other hormone levels in the body,     compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through     the vein) injection.      The population who are eligible to take part in the study are healthy male volunteers, aged     between 18 and 60 years of age.   "
101274|NCT01960517|"     This is a single centre, non-randomised, baseline controlled, prospective pilot clinical     trial to be undertaken at Rotherham General Hospital, Rotherham, UK.      The study will examine the safety and performance of a new urinary catheter, the Alternative     Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK) which     has been developed to reduce the morbidity of long-term catheterisation and the acknowledged     deficiencies of the conventional Foley urinary catheter.   "
101275|NCT01960504|"     BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of     this study is to assess the safety and clinical performance of the drug eluting absorbable     metal scaffold (DREAMS 2nd Generation).   "
101276|NCT01960491|"     The objective of this study is to evaluate the effectiveness and the safety of the     intracardiac septal closure device (CBO), as well as the practicability of implantation of     this device using the accessories (DS for CBO).   "
101277|NCT01960478|"     In the USA, every year 795,000 patients suffer a cerebral vascular accident (CVA), which     represents a yearly cost of $73.7 billion. CVA is the third main cause of death and the main     source of acquired handicap in adults, as a result it is now a key priority in public health     and part of  The CVA National Action Plan 2013-2014.      Copeptin is a polypeptide, by- product of Vasopressin metabolism. The increase of Copeptin     plasma level, as for Vasopressin, is connected to hydric balance disorders found in     cardio-vascular, renal and endocrine diseases. This link has already shown its interest in     the early diagnosis of myocardial infarction and, in a more indirect way, CVA.      Copeptin is associated with acute endogenous stress. It seems to have interesting potential     in the diagnosis of CVA by its negative predictive value like D-dimeres in pulmonary     embolism. Proadrenomedullin and Brain Natriuretic Peptide (BNP) are both associated with the     prognosis of cardio-vascular diseases and could be interesting in evaluating CVA prognosis.   "
104875|NCT01913392|"     A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the     potential renal transplant candidate who is denied acceptance due mainly to the morbid     obesity.   "
101344|NCT01959607|"     The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the     amount of nicotine absorbed) following a single use of the THS 2.2 compared to the PK     profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine     gum in a Japanese population.   "
101279|NCT01960452|"     Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep,     and/or non-restorative sleep, leads to significant daytime dysfunction and increased health     risks. A commonly held hypothesis is that insomnia is caused by a state of hyperarousal, but     the neurobiological mechanisms of hyperarousal in insomnia are poorly understood, in part     because of limitations in our ability to image the brain during normal human sleep with     sufficient temporal resolution. Furthermore, the efficacy of insomnia treatment is judged by     subjective report of the patient and demonstration of changes in sleep latency and/or sleep     amount which are generally small in magnitude; there are currently no data to demonstrate     that insomnia treatments correct any functional abnormalities in the sleep process that     likely contribute to neurobehavioral abnormalities and health risks. The goals of the     proposed study are to use high density EEG to define abnormalities in specific aspects of     sleep in insomnia patients compared to healthy sleeping control subjects to define biomarkers     that will both increase our understanding of the pathophysiology of insomnia as well as     provide targets to assess treatments for insomnia.   "
101280|NCT01960439|"     The purpose of this study of this study is to assess the responsiveness and validity of CIMS     (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis)     clinical disease activity by measuring:      The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo     Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS     (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of     a treatment of known efficacy in UC.   "
101281|NCT01960426|"     Utilization of health resources in a testing based strategy versus an empiric dose escalation     strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response     to infliximab or adalimumab.   "
101282|NCT01960413|"     In this feasibility trial, the investigators will compare participants treated with     montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8     weeks.   "
101283|NCT01960400|"     The efficacy of the current standard non-pharmacological treatments for complex regional pain     syndrome (CRPS), a painful syndrome mostly occurring after musculoskeletal trauma, is     suboptimal. It thus appears essential to examine new non-pharmacological therapeutic imagery     (GMI) - a non-pharmacological approach with the highest level of evidence (level II). As     suggested by the most recent clinical guideline 2, a potential solution would be to add an     electrotherapeutic procedure - transcranial direct current stimulation (tDCS) - that may     prove effective in modulating cortical excitability and reducing the effect of cortical     reorganization on pain. Given the positive results previously obtained in patients with     neuropathic pain, it is hypothesized that tDCS will prove to be an innovative add-on     treatment method for CRPS patients, and help reduce pain and disability.   "
101284|NCT01960387|"     The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated     treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For     this prospective study, we propose the use of clofarabine and cytarabine for second course     induction therapy for patients with persistent AML after treatment with an anthracycline and     cytarabine.   "
101285|NCT01960374|"     The purpose of the study is to assess the safety, tolerability and PK of selumetinib     (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian     volunteers following administration of a single dose. Standard safety assessments including     ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events and     an optional exploratory pharmacogenetics will be performed.   "
101286|NCT01960361|"     The current prospective clinical study's aim is to determine ABT's ICE implant survival rate,     crestal interproximal bone resorption during 24 months post implant insertion and to     assimilate the drilling sequence during the clinical use of ICE implants.   "
101287|NCT01960348|"     The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in     patients with transthyretin (TTR) mediated amyloidosis   "
101288|NCT01960335|"     Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity     epidemic. Increased dietary protein is one effective strategy. For example, increased whey     protein ingestion with and without exercise training is associated with enhanced weight loss,     body composition and subjective hunger in overweight and obese individuals. Our findings     suggest that the effects of whey protein ingestion occur independent of a calorie-restricted     diet and to a greater extent in individuals following a combined exercise program of     resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic exercise training     compared to standard resistance training.   "
101289|NCT01960322|"     The specific aim is to pilot-test our developed intervention manual's ability to improve     patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels)     in participating centers.   "
101290|NCT01960309|"     This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive     techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The     primary objective is to quantify coronary artery disease, as determined by coronary CT and     MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate     coronary calciumscore to postoperative levels of troponin.   "
101291|NCT01960296|"     Patients who on taking clopidogrel are randomized to either continue clopidogrel into general     surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel     after surgery. The investigators track the development of bleeding complications that may     develop within 90 days of the surgery. Patients are medically cleared to be in either arm of     the study by their cardiologist and surgeon. There is currently no evidence to support for or     against the use continuation or discontinuation of clopidogrel prior to general surgery.   "
101292|NCT01960283|"     Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not     found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment     consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic     alternatives exist. Methotrexate, which is not expensive and often prescribed by     dermatologists, has been efficiently tried in an open study on severe chronic idiopathic     urticaria, and also in few case reports.   "
101419|NCT01958606|"     The objective of this study was to compare the effectiveness of high intensity interval     training (HIT) and traditional aerobic training for persons with stroke.   "
101293|NCT01960270|"     Unilateral sacral neuromodulation (SNM) has emerged as a valuable treatment for patient with     low urinary tract dysfunction when failure or bad tolerance to anticholinergic treatment for     overactive bladder. However, in the medium or long term, some patients failed to benefit from     unilateral stimulation (unilateral neuromodulation). A contralateral stimulation could be     tested then implanted to restore the efficacy. An other option is to perform a bilateral     stimulation of the sacral nerves that could lead to a summation effects better than     unilateral stimulation. Therefore, if a unilateral sacral nerve stimulation fails, a     contralateral or a bilateral test should be considered.   "
101295|NCT01960244|"     The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy,     clinical outcomes, and patient-reported outcomes over time. The registry represents a     collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical     Research Institute, lipid specialists, cardiologists, primary care providers, quality     improvement personnel, and patients, all aiming to increase FH awareness, promote optimal     disease management, and improve FH outcomes.   "
101296|NCT01960231|"     Type 2 diabetes mellitus patients exhibit many glucose homeostasis abnormalities in different     tissues and organs. Among the more important defects are disturbed hepatic glucose metabolism     and defective pancreatic β-cell function. Hexokinase IV, commonly known as glucokinase, is     the predominant hexokinase expressed in the liver, the pancreatic β-cells (where it functions     as the glucose sensor for insulin secretion) and in glucose-sensory cells in the hypothalamus     and gut.      The glucokinase gene contains two distinct promoters. The downstream one is active only in     hepatocytes and the upstream promoter is active only in extrahepatic glucose sensory-cells.     Alternative promoters enable differential regulation of gene transcription in liver and     extrahepatic sites. In pancreatic β-cells, glucokinase expression at the mRNA level is     largely constitutive, whereas in the liver it undergoes large adaptive changes in response to     nutritional states, enabling larger changes in glucokinase activity than would otherwise be     possible by post-transcriptional regulation alone.      Most of the MODY-2 patients were found to have glucokinase mutations located in areas that     are common to the liver and pancreas. The diabetes in these patients is related both to     defect in insulin secretion and abnormal hepatic glucose metabolism. Point mutation in the     pancreatic specific promoter was recently described as a cause for impaired fasting glucose     [Diabetes 58:1929-1935, 2009]. The investigator have recently identified a MODY-2 family with     a genetic defect that is located in the pancreatic promoter, sparing the liver promoter. This     family demonstrates that abnormal insulin secretion alone (perhaps together with other     extrahepatic glucose sensors) is enough to cause diabetes.      In this study, the investigators would like to use an oral glucose tolerance test (OGTT) and     continuous glucose monitoring (CGM) technique in order to elucidate the relative roll of the     hepatic glucokinase in normal glucose homeostasis. This issue is complicated by the fact that     in addition to glucokinase, hexokinase isoenzymes I, II and III are also expressed at very     low levels in hepatocytes. They are an important back-up mechanism when glucokinase activity     is compromised, as in liver cirrhosis or murine models with liver-specific glucokinase     knock-down. However, impaired hepatic glycogen synthesis was demonstrated in MODY-2 subjects     (JCI 1996:98:1755). By comparing members of the investigators MODY-2 family with members of     other MODY-2 families and normal controls the investigators hope to shade some light on this     question.   "
101297|NCT01960218|"     To determine whether, and if so, which gas exchange parameters measured on the Shape-HF     Cardiopulmonary Exercise Testing System predict 30 and 180 day re-hospitalization in subjects     discharged from hospitalization for an episode of acute decompensated heart failure.   "
101298|NCT01960205|"     The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed     people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4     inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its     influences on the targets of obesity related metabolic abnormalities, to explore new ways for     intervention on populations with pre-diabetes and obesity .   "
101299|NCT01960192|"     The purpose of this study is to evaluate the efficacy and safety of FVD regiment     (fotemustine, teniposide and dexamethasone ) for patients with primary CNS lymphoma.   "
101300|NCT01960179|"     Primary Objective:      To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and     52 weeks in patients with type 2 diabetes in Japan      Secondary Objective:      To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52     weeks on:        -  HbA1c (Glycated hemoglobin A1c) reduction;        -  Fasting plasma glucose;        -  Body weight.   "
101301|NCT01960166|"     The investigators proposed study will investigate the efficacy of tablet computer distraction     as an analgesic for the pain associated with various painful procedures in the emergency     department. Since prior studies have shown that distraction by a parent or nurse can be an     effective analgesic, there is reason to believe that tablet computer distraction will     similarly reduce pain. Participants in the control group will receive a cartoon on the TV     monitor in the patient room, while participants in the study group will receive a more     immersive distraction of playing a game or watching a cartoon (for children too young to play     a game) on a tablet computer. Data from this study will help inform best practices for     administering painful procedures in a way that minimizes pain.   "
101302|NCT01960153|"     PITCH-ER is an ancillary study of PITCH-HF (NCT01910389). The goal of the PITCH-ER ancillary     study is to evaluate the rate of decline in renal function and frequency of development of     acute kidney injury (AKI) in patients enrolled in PITCH-HF (who have heart failure and     pulmonary hypertension) treated with chronic tadalafil treatment compared to placebo.   "
101303|NCT01960140|"     The purposes of this study are to determine the effects of baricitinib on the time it takes     to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is     when given alone and in combination with simvastatin. Side effects will be documented. The     study will last approximately 7 days from the first dose to the end of the study (not     including screening or follow-up).   "
104876|NCT01913379|"     A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100     and Itraconazole.   "
101304|NCT01960127|"     Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an     impact on morbidity and mortality. Regular aerobic exercise training is a proven effective     therapy to improve exercise capacity in healthy and clinical populations. The effect of this     training has not yet been evaluated in the decompensated cirrhosis patient population. The     safety of this intervention also requires further study. Using a randomized controlled     design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic     exercise training on aerobic capacity, functional performance, and muscle mass in     decompensated cirrhosis patients.   "
101305|NCT01960114|"     The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg     (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar     extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg     tablets) in a sub-group of subjects.   "
101345|NCT01959594|"     This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in     healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days   "
101306|NCT01960101|"     Dry mouth is in most cases due to iatrogenic causes, particularly drugs. The existing     products such as saliva substitutes are often disappointing (bad taste, poor efficiency).      Our hypothesis has considered the empirical observations made by some patients with     xerostomia who consumed milk products to relieve the dry mouth syndrome from which they     suffered. With this clinical observation, a closer collaboration has been undertaken with     research laboratories specialising in food and especially milk. Through its composition, the     dairy product in itself provides relief for the patient, due both to its physical and     biochemical properties, which could explain these observed improvements, and elements related     to the phenomena of consumption of food as an alternative to medication. In the latter,     hedonism takes on a role which has not been previously assessed. Initial work undertaken with     the department of applied research at the National Dairy Industry School (ENIL) led to the     prototyping of a new natural milk, which is the subject of this application for development,     to qualify and adapt a product with a health benefit in patients suffering from xerostomia.      To further develop this project we will initiate a sequential clinical trial by groups of     five ambulatory patients with xerostomia (patients taking antidepressants followed in     psychiatry appointments). The clinical tests will be organised by the CIC with the     psychiatric wards of the University Hospital of Besançon. Each group of 5 patients will test     a similar product for 14 days. The information collected after a series of tests with a group     of patients will be translated by changing the ENIL specifications to produce a new     mini-series of products. This repetition will be carried out up to 3 times if necessary to     help achieve a satisfactory product in terms of taste, texture and lubrication properties,     which will then be tested in a randomized controlled cross-over study of the efficiency and     acceptability of the new LactoXeros product versus a reference product (Aequasyal ®,     Oxidized Glycerol Triester) on a group of 32 patients at the University hospital of Dijon.      A natural way to combat xerostomia at the interface of patient diet, such as we propose,     could help improve quality of life for patients, minimize harmful effects (infection, decay)     and promote adherence of patients to treatments which are responsible for xerostomia.   "
101307|NCT01960088|"     The study aims to expand the evidence supporting pharmacy provision of adolescent vaccines,     including human papillomavirus (HPV) vaccine. In the first part of the study, we will     characterize parents' attitudes and support for pharmacy provision of adolescent vaccines in     a national survey. In the second part of the study, we will provide HPV vaccines and other     vaccines (Tdap, meningococcal, varicella, influenza) to 200 adolescents in a local community     pharmacy in Chapel Hill, North Carolina. This portion of the study will identify the systems     and workflow needed to provide vaccines effectively and safely, characterize parents' and     their adolescents' attitudes toward receiving vaccine services in a pharmacy, and     characterize pharmacists' attitudes toward providing adolescent vaccine services in a     pharmacy.   "
101308|NCT01960075|"     The primary objective is to determine the most effective and/or the least effective treatment     of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There     are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and     valproic acid (VPA).      The second objective is comparison of three drugs with respect to secondary outcomes.      The final objective is to ensure that the trial is informative for treatment of established     SE in children by describing the effectiveness, safety, and rate of adverse reactions of     these drugs in children.   "
101309|NCT01960062|"     Between October 1 and November 30, 2011, participants will be enrolled in this study     comparing the use of MyLink web-based care with usual CPS care. Patients age 18- 74 with     HbA1c ≥ 9% in the last 12 months will be identified. It is expected that approximately 32     people (16 per group) will participate in the study. Once eligible patients are found, they     will be randomly assigned (like the flip of a coin) to usual care with the CPS or usual care     with the CPS plus web-based care using the MyLink software. Participants using the software     will agree to upload their glucometer measurements using the software every 2- 4 weeks.     Following the receipt of the glucometer data, either electronically from intervention group     participants or verbally from the control group participants, medications/ doses will be     adjusted by the pharmacist as needed to achieve HbA1c goals. Participants in both groups will     receive a follow-up HbA1c 2-4 months after enrollment to see if there were any significant     changes in HbA1c between groups.   "
101310|NCT01960049|"     Abdominal wall incisions used for liver surgeries are associated with significant     postoperative pain and disability. Epidural analgesia is often contraindicated in these     patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and     opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW)     catheters can be placed during surgical closure along the incision line and can be used to     administer local anesthetics for postoperative pain. The study is a multi-centre,     double-blind, randomized controlled trial involving 120 patients undergoing elective liver     surgery. Patients will be randomly assigned to AW catheter group treated with drug or control     treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard     patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no     local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain     scores, side-effects, chronic pain and complications.   "
101322|NCT01959893|"     Fibromyalgia Syndrome (FMS) is a highly prevalent condition, often affecting individuals at     the prime of life, causing severe reduction of quality of life and productivity, as well as     social isolation, anxiety and depression.      FMS is a condition characterized by chronic widespread pain, considered to be a manifestation     of central nervous system sensitization, leading to increased processing and transmission of     pain. At the same time however, it has become gradually more evident, that FMS is not merely     a pain syndrome. Those patients who suffer from the full-blown clinical syndrome of FMS     inevitably describe many additional symptoms beside pain. While some of these symptoms, such     as heightened sensitivity to external stimulations (e.g. noise and light), can easily be     understood as representing aspects of the basic underlying propensity towards central     sensitization, other symptoms are not so easily explained in this context.   "
101328|NCT01959815|"     Patients with scleroderma can develop heart failure due to high blood pressure in the lungs     (a condition called pulmonary arterial hypertension). It is important to find pulmonary     arterial hypertension early, so that it can be treated before heart failure develops.     However, the tests that we now use to find the earliest form of this disease in scleroderma     patients are not good enough. This study will examine whether tests performed during exercise     can improve our ability to find early pulmonary arterial hypertension. The study will also     try to identify genes that are responsible for the development of pulmonary arterial     hypertension.   "
101329|NCT01959802|"     Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after     surgery for macular pseudohole   "
101330|NCT01959789|"     The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2     days after the first bleaching session without increasing the bleaching-induced tooth     sensitivity   "
101311|NCT01960036|"     The long-term objective of this study is to improve women's substance use disorder (SUD)     treatment. The immediate project goal is to test the efficacy of an innovative mind-body     intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use     relapse among women in SUD treatment.      A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body     psycho-education approaches of interoceptive training and mindfulness to develop     somatically-based self-care skills and to facilitate emotion regulation. A three-group,     randomized clinical trial using repeated measures, this project will enroll and randomize 225     women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and     Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study     conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up.      The primary aim is to test the hypothesis that MABT will result in reduced substance use and     related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim     is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse     community treatment facilities, serving racially diverse patients, will be recruited for     study participation. This study builds on promising preliminary evidence of MABT feasibility     and acceptability in substance use disorder treatment for women, and addresses the need for     more clinical research aimed at improving SUD treatment outcomes for women.   "
101312|NCT01960023|"     The FC-7 study is designed as an open label, single arm, Phase I/II dose-escalation study     evaluating the combination of neratinib and cetuximab in patients with metastatic colorectal     cancer primary tumor that is quadruple wild-type  (wild-type KRAS, NRAS, BRAF, PIK3CA). The     primary aim in the Phase I portion of this study is to determine the safety and tolerability     of the two-drug combination. The primary aim of the Phase II part is to determine the overall     objective response rate (complete and partial responses) by Response Evaluation Criteria in     Solid Tumors (RECIST 1.1).      Patients will receive concurrent therapy with cetuximab (400 mg/m2 IV loading dose followed     by 250 mg/m2 IV weekly), and neratinib.   "
101313|NCT01960010|"     The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution     compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.   "
101314|NCT01959997|"     The objective of this study is to compare the elimination of atrial fibrillation in patients     with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when     undergoing repeat PVI (control) vs repeat PVI plus renal denervation.   "
101315|NCT01959984|"     The object of this study is to compare 100g Standard Noodles  with traditional     carbohydrates including 75g glucose solution in 300ml water and 100g steamed bread in the     diagnosis of diabetes mellitus.      In this study, we will compare the different effects of 100g Standard Noodles Tolerance     Testand 75g Oral Glucose Tolerance Teston plasma glucose, insulin, c- peptide level and     the relevant hormones level including glucagon-like peptide-1( GLP-1) and glucagon. Besides,     in part of the subjects, the difference between 100g Steamed Bread Tolerance Test, 100g     Standard Noodles Tolerance Test and 75g Oral Glucose Tolerance Test will be further     evaluated.   "
101316|NCT01959971|"     Primary Objective:      To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured     by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein     (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).      Secondary Objectives:      To assess the effects of SC doses of alirocumab on:        -  Various parameters of the metabolism and turnover in plasma of different lipoproteins        -  Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol          (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB,          lipoprotein(a) (Lp(a))        -  Lipoprotein particle size profile        -  PCSK9 (free and total) concentrations in serum To assess safety and tolerability of          alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum          alirocumab concentrations.   "
101317|NCT01959958|"     Pediatric patients with sickle cell disease are at greater risk for exhibiting nocturnal     enuresis (bedwetting) compared to the general population. This increased risk has been     attributed to a decreased ability to concentrate urine caused by sickling-induced     nephropathy. The sociodemographic, psychosocial, and medical factors associated with     nocturnal enuresis are not well defined. In addition, the impact of these behaviors on     emotional and behavioral functioning, along with health-related quality of life are not     clear. Despite the availability of evidence-based interventions for nocturnal enuresis, very     few families with a child with sickle cell disease have utilized these methods. The reasons     for this underutilization of interventions are not clear.   "
101318|NCT01959945|"     Flublok was studied previously in children 6 -59 months of age and demonstrated less than     satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the     initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population     will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This     clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q     in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study     may support further studies in younger children.   "
101319|NCT01959932|"     The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating     System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels     of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents     (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).   "
101320|NCT01959919|"     This study aims to investigate prospectively throughout a period of 3- 6 months and not to     exceed 12 months (according to local therapeutic plans) patients experiences of treatment     with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII     compared to their previous delivery system.   "
101321|NCT01959906|"     A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of     the CRM, is still controversial. The aim of this study was to compare the clinical     significance of a suspicious CRM to histologically positive (R1) and negative margin (R0)     resections in patients with pT3 esophageal and GE-Junction tumors.   "
101644|NCT01955668|"     In Part A to investigate the safety and tolerability of AZD6738 when given orally to patients     with relapsed/refractory CLL, PLL or B cell lymphoma.      In Part B to investigate the safety and tolerability of AZD6738 when given orally to patients     with prospectively identified 11q deleted or ATM deficient, relapsed/refractory CLL   "
101332|NCT01959763|"     This intervention aims to reduce obesity by using new type of nutritional and lifestyle     therapy and in parallel, tailored persuasive information and communications technology     (ICT)-technology based application. The study hypothesis is that obesity cannot be reduced     just by distributing nutritional information. Instead, by influencing also the eating     behavior, permanent lifestyle changes can be achieved. The effect of the therapy along the     time-line, the health information literacy of the study persons and the changes in it will be     studied at different phases of the intervention. The research will be carried out in three     groups of different nutritional therapies with a parallel ICT-intervention group for each.   "
101333|NCT01959750|"     ICU caregivers face up to a demanding job with a high level of technical skills, a stressful     environment, and a heavy work load. They run a high risk of developing burnout that can     impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff     quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised     controlled intervention aimed at reducing such distresses had been run until now.      This study allowed finding a new method of psychological support applicable in the special     environment of ICU. Our findings suggest that psychologists specifically assigned to treat     ICU caregivers might be beneficial on their burnout.   "
101334|NCT01959737|"     The first hours after birth are a sensitive period for promotion of optimal     mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are     high in the first hours after birth due to high oxytocin levels. Developing optimal     mother-child-interaction is more difficult for preterm mothers because mother and child are     separated after birth and the preterm infant is not able to show strong signs to promote     maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and     their mothers for 60 minutes within the first hours after birth improves     mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity     of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with     or without SSC after birth.   "
101335|NCT01959724|"     Evaluation of clinical characteristics and surgical outcome for macular detachment associated     with peripapillary intrachoroidal cavitation with or without pathologic myopia.   "
101336|NCT01959711|"     Laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal     tumors replacing open adrenalectomy. The most popular lateral transperitoneal laparoscopic     adrenalectomy (LTLA) approach has been recently challenged by an increasing popularity of the     posterior retroperitoneoscopic adrenalectomy (PRA) approach which is believed by many     surgeons as an easy to learn, reproducible and beneficial for patients. However, this belief     is not evidence-based, so far. The aim of this study is to clarify if PRA is superior to the     LTLA as minimally invasive approach to small and benign adrenal tumors.   "
101337|NCT01959698|"     This phase I/II trial studies the side effects and best dose of carfilzomib when given     together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well it works     in treating patients with stage I-IV diffuse large B-cell lymphoma that has returned     (relapsed) or that has not responded to treatment (refractory). Carfilzomib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as rituximab, may block cancer growth in different ways by targeting certain     cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, also work     in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with     rituximab, ifosfamide, carboplatin, and etoposide may be a better treatment for diffuse large     B-cell lymphoma.   "
101338|NCT01959685|"     To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in     healthy adult male subjects as the dose to be investigated in a thorough QT     interval/corrected QT interval (QT/QTc) study.   "
101339|NCT01959672|"     This phase II trial studies how well combination chemotherapy with or without oregovomab     followed by stereotactic body radiation therapy (SBRT) and nelfinavir mesylate works in     treating patients with pancreatic cancer that has spread to nearby organs or tissues. Drugs     used in chemotherapy, such as gemcitabine hydrochloride, leucovorin calcium, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal     antibodies, such as oregovomab, can block tumor growth in different ways by targeting certain     cells. Stereotactic body radiation therapy is a specialized radiation therapy that sends     x-rays directly to the tumor using smaller doses over several days and may cause less damage     to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells more sensitive to     radiation therapy. Giving combination chemotherapy with or without oregovomab followed by     SBRT and nelfinavir mesylate may kill more tumor cells.   "
101340|NCT01959659|"     This non-interventional, cross-sectional survey and retrospective review will evaluate the     medical resource utilization and burden of illness in patients who have persistent symptoms     of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not     had an acute exacerbation in the 3 months prior to enrolment. Medical records will be     reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at     a single visit will include rating scales and questionnaires that reflect the clinical status     and the quality of life of the patients and the economic impact of schizophrenia.   "
101341|NCT01959646|"     This is a nutritional intervention study using healthy overweight/obese humans to investigate     if a supplement made from aged garlic extract has an impact on immunity. Following a baseline     blood draw, participants will consume the capsules (garlic or placebo) for 42 days, at which     time a second blood draw will occur. Tests for immune function and inflammation will be     performed on both the baseline and 42 day samples. The investigators anticipate that the     immune functions and biomarkers that are inflammatory in an overweight/obese population will     be returning to normal after 42 days of consumption of this supplement. The investigators     predict that AGE supplementation will benefit immunity and improve function while reducing     inflammation in a stressed population (inflamed obese).   "
101342|NCT01959633|"     The hypothesis of this study is to evaluate the safety and the efficacy of     Vemurafenib/PEG-interferon combination and the IFNAR1 upregulation lead by this treatment.   "
101507|NCT01957449|"     To determine the safety and efficacy of administration of propranolol for reducing heart rate     and blood pressure in burn injury.   "
101346|NCT01959581|"     The purpose of this study is to assess: 1) how infants move their bodies to explore, play,     and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these     abilities can be advanced in a high-risk group through the use of a movement assisting     device.   "
101347|NCT01959568|"     Purpose: to assess the efficacy and safety of double tamponade versus silicone oil tamponade.      Design: parallel-group study with balanced [1:1] stratified block randomization. Eligible     participants are all adults aged 18 or over with first diagnosed rhegmatogenous total retinal     detachment with retinal breaks located both in upper and lower retina. Also investigators     include those patients with total retinal detachment with proliferative vitreoretinopathy     (PVR) in which it is impossible to remove epiretinal membranes completely during the surgery     (with arbitrary retinal breaks localization). Exclusion criteria are severe concomitant eye     pathologies (glaucoma, diabetic retinopathy, macular hole, traumas etc) and eye length more     than 27mm.      Patients are randomized in two groups (test group and control group).      In the test group patients undergo subtotal vitrectomy, epiretinal membrane removal,     perfluorodecalin (PFD) tamponade, retinal photocoagulation. After that the surgeon replaces ½     of PFD volume by conventional SO (with density less than one of water). The result is     vitreous cavity (VC) filled in a half with PFD and in another half - with SO. In the control     group patients undergo subtotal vitrectomy, epiretinal membrane removal, PFD tamponade,     retinal photocoagulation and PFD-SO exchange, so the result is VC filled with conventional     or heavy SO, depending on predominant retinal breaks location. 30 days after the surgery in     both groups tamponing agents are removed from VC and VC is filled with sulfur hexafluoride     gas (SF6) which dissolves during 1 month. Follow-up is at least 12 months.      Along with standard examinations, after SF6 gas dissolution investigators perform spectral     optical coherence tomography (OCT) and microperimetry. With OCT investigators measure     thickness of retinal inner and outer nuclear layers. With microperimetry investigators     determine light sensitivity in 12° and 4° zones from the fixation point.      Outcome measures: reattachment rate, best corrected visual acuity (BCVA), intraocular     pressure (IOP), thicknesses of inner and outer nuclear layers according to the OCT, light     sensitivity according to microperimetry, the rate of cataract formation in phakic eyes and     the rate of tamponing agents emulsification.      For final analysis each group will include 145 participants.      OCT, microperimetry data and visual acuity will be compared between the groups using     Student's t-test; proportions will be compared using exact Fisher's test.   "
101348|NCT01959555|"     This study is conducted in Europe. The aim of the study is to update the knowledge about the     prevalence and severity of congenital haemophilia (A and B) in Spain.   "
101349|NCT01959542|"     In this research study, the investigators are trying to determine if there are measurable     changes in prostate MRI that will help predict those who will or will not respond to Androgen     Deprivation Therapy (ADT) and External Beam Radiation Therapy (EBRT) The first baseline     prostate MRI prior to the start of treatment is standard of care. The participant's ADT/EBRT     treatment is also standard of care, as advised by their doctor. It is the 3 follow up     prostate MRIs during ADT/EBRT treatment, and 4 follow up serum PSA levels that are part of     this research study.   "
101350|NCT01959529|"     This trial is conducted globally. The aim of this trial is to compare cardiovascular safety     of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of     cardiovascular events.   "
101351|NCT01959516|"     This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium     during the first hours after dosing and their impact on pulmonary function, COPD symptoms and     ability to perform daily activities by the patient.   "
101352|NCT01959503|"     This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular     Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically     sealing areas of leakage.   "
101353|NCT01959490|"     This phase II trial studies how well trastuzumab and pertuzumab or bevacizumab with     combination chemotherapy works in treating patients with stage II-III breast cancer.     Monoclonal antibodies, such as trastuzumab, pertuzumab, and bevacizumab, can block tumor     growth in different ways. Some block the ability of tumors to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in     chemotherapy, such as docetaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide,     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving trastuzumab and pertuzumab or a     commercially marketed formulation of bevacizumab without modification with combination     chemotherapy may kill more tumor cells.   "
101354|NCT01959477|"     This clinical trial studies personalized dose monitoring of busulfan and combination     chemotherapy in treating patients with Hodgkin or non-Hodgkin lymphoma undergoing stem cell     transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer     cells by stopping them from dividing or killing them. After treatment, stem cells are     collected from the patient's peripheral blood or bone marrow and stored. The stem cells are     then returned to the patient to replace the blood-forming cells that were destroyed by the     chemotherapy. Monitoring the dose of busulfan may help doctors deliver the most accurate dose     and reduce toxicity in patients undergoing stem cell transplant.   "
101645|NCT01955655|"     This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their     treatment.   "
101357|NCT01959438|"     In vitro studies have demonstrated that sodium selenite in sufficient concentration and     during sufficient time have a high tumoricidal capacity. This is found in many human cell     types as leukemia cells, mesothelioma and non-small cell lung cancer cells. A minority of     cell lines seem to be resistant. The question from a clinical point of view is: Is it     possible with respect to toxicity to administer sodium selenite to patients in sufficient     dose and during sufficient time to get responses in patients with cancer? We have performed     first part of phase-1 study and found MTD of 10.2 mg/m2 if given as 10 daily infusions during     12 days. We have recorded limited anti-tumor effect in this treatment regimen. However, in     vitro data suggest that low concentration of continuous exposure for 51 h is much more     effective. Now we are planning to continue the phase-I trial with modified protocol.      More specific:        1. Phase I: Find maximal tolerable dose with continuous infusion        2. Phase II: Use MTD and study responses, if any   "
101358|NCT01959425|"     The objective of this study is to determine the safety of discontinuing oral anticoagulation     therapy in high risk patients who have had a successful cardiac ablation and remain AF     recurrence free for 3 months post ablation.   "
101359|NCT01959412|"     The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and     27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.   "
101360|NCT01959399|"     The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the     pharmacokinetics of rosuvastatin in healthy adult male and female subjects.   "
101508|NCT01957436|"     This is a multi-center phase III study to compare the clinical benefit of androgen     deprivation therapy (+/- docetaxel) with or without local radiotherapy with or without     abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.   "
101361|NCT01959386|"     This observational study will evaluate the efficacy, safety, tolerability and participant     reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants     with HER2-positive early breast cancer in routine clinical practice. Data from eligible     participants will be collected for the duration of their treatment (approximately 1 year) and     for 1-2 years of follow-up.   "
101362|NCT01959373|"     Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both     upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not     always easy to establish. The only technique used in routine to assess the corticospinal     dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is     largely dependent on LMN state and is based on artificial motor cortex activation.      The main objective of our study project is to evaluate a new method assessing functional     changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical     coherences, it could be possible to show modifications in both cortico-muscular relationship     and in cortical activity coordination which could be related to clinical state in ALS     patients. We notably expect a decrease in cortico-muscular coherence in ALS patients.     Furthermore, these analyses could provide new insights in motor system plasticity phenomena.     We expect a partial covering of voluntary motor command by cortical areas adjacent to primary     motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor control     may be assumed by ipsilateral corticospinal tract could be tested by coherence analyses.      Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This     method has the advantage to be painless and not to use artificial stimulations as it is used     in TMS.   "
101363|NCT01959360|"     The aim of the present study is to explore the most efficient surgical approach in total hip     replacement in short and long term when concerning strength, functionality and postoperative     complications.      The objective is to register muscular strength, hip joint functionality/mobilisation and     complications after total hip arthroplasty (THA) performed by two minimal invasive/incision     surgeries (MIS) versus the traditionally lateral approach.      The primary working hypothesis is that due to a minimal dissection and reduced trauma in the     muscles, patients will tolerate early hospital discharge better after MIS than after     traditional lateral surgery. Patients in the MIS group will also be more active and maintain     muscular strength and hip joint functionality/mobilisation better than patients in the     lateral group.   "
101364|NCT01959347|"     The overarching goal of this randomized trial is to estimate the effect of combined     midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to     MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include     estimating the effect of combined treatment compared to MUS on improving overactive bladder     (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional     treatment, time to failure and identifying predictors of poor outcomes in this MUI     population.      A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and     vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.   "
101365|NCT01959334|"     In recent past years, regulatory agencies such as FDA and EMA have outlined and recommended     adoption of a risk-based approach to evaluating and mitigating immune responses to     therapeutic proteins that may adversely affect their safety and efficacy. In their     recommendations, both transient and persistent antibody responses should be combined to     determine the overall immunogenicity of a product in a given condition. In particular,     persistent antibodies are of high importance, since patients with persistent antibodies are     more likely to experience clinical sequelae in terms of safety and efficacy, while a     transient antibody response can resolve without further consequence.      The present study will provide information on immunogenicity of AMG504-1 with regards to the     potential development of high antibody titers or neutralizing antibody activity which may     lead to loss of efficacy or an increased risk of an adverse reaction.   "
101366|NCT01959321|"     This multi-center observational study examines risk factors for HCV transmission from mother     to baby.   "
101367|NCT01959308|"     Immunosuppressive therapy is fundamental in post-liver transplant patients to prevent and     reduce the incidence of acute cellular rejection. Non-compliance to treatment leading to     graft rejection is a well-recognized event. This study aims to study the differences in     patient compliance to immunosuppressive treatments and patient preference.   "
101368|NCT01959295|"     To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.   "
101369|NCT01959282|"     The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with     moderately to severely active ulcerative colitis (UC).   "
102772|NCT01940952|"     The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on     cognitive function in patients with Alzheimer's disease.      This study is a randomized, double blind, placebo-controlled multicenter study.   "
101371|NCT01959256|"     This study will test the hypothesis whether visual field defect caused by chronic stroke     could be improved by visual perceptual learning. The secondary hypothesis is that improvement     of visual field defect would be accompanied by connectivity changes in visual networks. In     addition, investigators will evaluate whether improvement of visual field defect could     achieve improvement of subjective visual function.   "
101372|NCT01959243|"     To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025%     versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51%     of subjects will be 40 years of age or older.   "
101373|NCT01959230|"     To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with     its vehicle for treating ocular redness in a population of adult and geriatric participants     with ocular redness.   "
101439|NCT01958346|"     We propose the additional technique of lingual traction or tongue pulling in conjunction     with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts     at and decreasing time to intubation of the difficult airway and rescuing otherwise failed     intubation attempts. Induction of general anesthesia causes relaxation and approximation of     the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating     unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual     traction can assist in diminishing these problems by clearing the tongue away from the soft     palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in     the unanticipated difficult airway patient.   "
101374|NCT01959217|"     Medication adherence rates among youth living with HIV are inadequate to effectively manage     the disease, and novel interventions grounded in basic behavioral sciences are needed. This     multi-site phased (3 phases) study plans to translate basic cognitive neuroscience regarding     prospective memory (PM) into a more potent adherence intervention for youth living with HIV     (YLH).      The phases are:      Phase 1: To improve PM in basic laboratory tasks in YLH with and with out substance abuse.        -  Hypothesis 1: Manipulations in three theory-based components of PM (strategic encoding,          self-monitoring and cue salience) will improve PM within each participant.      Phase 2: To conduct proof of concept studies of a text-delivered PM intervention for taking     ART in YLH with suboptimal adherence.        -  Hypothesis 2: Using a multiple baseline across subjects design, adherence to ART will          improve following initiation of the PM adherence intervention and will be maintained for          6 weeks after tapering of the intervention.        -  Hypothesis 2a: Similar feasibility, tolerability, and adherence improvement trends will          be seen in youth with and without substance problems.      Phase 3: To conduct a pilot randomized clinical trial of the PM intervention compared to     traditional text message reminders (comparison condition) in non-adherent youth stratified by     substance use.        -  Hypothesis 3: Youth randomized to receive the PM intervention will show greater initial          and sustained improvements in adherence and viral load compared to those randomized to          the control condition.        -  Hypothesis 3a: We will explore trends in the data relative to substance abuse, but we          anticipate that the intervention will show promise for both substance using and non          substance using YLH warranting a larger clinical trial that can test for          substance-related mediators and moderators of the intervention.   "
101375|NCT01959204|"     The objective of this study is to characterize the pharmacokinetics and to evaluate the     safety of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent     subjects for postoperative pain.   "
101376|NCT01959191|"     Objective: To evaluate the early and late prognoses of patients according to platelet     reactivity after clopidogrel administration and determine whether the measurement of platelet     inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study     design        -  Prospective, observational, single-center study        -  Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be          enrolled.        -  Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be          measured by VerifyNow system.        -  Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1          year after surgery and subjects will be followed-up for 1 year about primary endpoint.        -  Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and          the cohort will be divided by the PRU cutoff value (low/high platelet reactivity          groups).        -  The primary and secondary endpoints will be compared between two groups   "
101377|NCT01959165|"     This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase     II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with     moderate to severe UC   "
101378|NCT01959152|"     The purpose of this study is to determine the feasibility of preserving low-frequency     acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and     severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the     HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.   "
101379|NCT01959139|"     This partially randomized phase I/II trial studies the side effects and best dose of     pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination     chemotherapy and to see how well they work compared with combination chemotherapy alone in     treating patients with newly diagnosed pancreatic cancer that has spread to other places in     the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better     by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as     leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether     combination chemotherapy is more effective with or without pegylated recombinant human     hyaluronidase in treating pancreatic cancer.   "
101380|NCT01959126|"     The purpose of this research study is to examine whether a stress reduction intervention can     improve health, mood and biological markers of cellular stress and aging in a group of     chronically-stressed maternal caregivers and healthy maternal controls.   "
101381|NCT01959113|"     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of     S. aureus skin infections. In addition, research in the investigator's lab has shown that     these patients have fewer protective antimicrobial Staphylococcal species such as     Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides     that play a role in protecting the skin from invading pathogens. In this study, the     investigator will attempt to decrease S. aureus colonization and increase colonization by     protective Staph species in AD patients. First the investigator will capture the bacteria on     subjects' lesional AD skin. Next the investigator will selectively grow the subject's     antimicrobial Staphylococcal colonies and place them into a base moisturizer. The moisturizer     plus bacteria will be applied to one of the subject's arms, and the moisturizer alone     (without bacteria) to the other arm. The investigator will then do a quantitative wash of the     bacteria growing on each arm one day later in order to determine whether the S. aureus     abundance was affected by the application of the transplanted bacteria.   "
101449|NCT01958216|"     So far, the liver has been the main target for cholesterol elimination. However, several     recent studies performed in mice have described a new route of cholesterol excretion, the     Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma     cholesterol in the feces directly via the intestine. Until now, only indirect evidence     suggests that TICE is also active in humans, the goal of this proof of concept study is to     provide the first proof of its existence in humans by using stable isotopes in patients with     bile duct diversion.   "
134121|NCT01529320|"     Determine the mean time to itch relief from the start of treatment with topic     methylprednisolone aceponate.   "
101440|NCT01958333|"     The purpose of this study is to investigate the effects of three different exercise programs     (e.g. low-intensity, medium-intensity, high-intensity) administered for six months on     health-related physical fitness, biochemical variables and general health outcomes in     high-risk employees, with about 2000 volunteers will participate in the randomized and     repeated-measure study.   "
101509|NCT01957423|"     The objective of this study was to evaluate the effect of Whey Protein (WP) and Soy Protein     (SP) nutritional supplements on nutritional status and disease activity in Crohn's disease     patients.   "
101510|NCT01957410|"     To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs)     obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect     changes in cortical plasticity in responders to a single IV infusion of ketamine as compared     to non-responders.   "
101382|NCT01959100|"     The occurrence of bronchiolitis obliterans syndrome (SBO) after allogeneic hematopoietic stem     cell transplantation (HSCT) is considered to be a chronic pulmonary graft versus host disease     (GVHD) that is associated with significant mortality and morbidity. The reported incidence of     SBO varies from 6 to 26% of allogeneic HSC recipients and is usually diagnosed within 2 years     after transplantation. The diagnosis of SBO relies on the occurrence of a new airflow     obstruction identified during pulmonary function testing, and the definition differs between     studies. Currently, no curative immunosuppressive treatment is available, and recent data     suggest that the use of these treatments, especially corticosteroids, should be limited     because of their toxicity. The impairment of lung function parameters is likely caused by     fibrous small airway lesions. Few data on the pathogenesis of SBO after allogeneic HSCT are     available. Several hypotheses are based on the occurrence of SBO during chronic graft     rejection after lung transplantation, which shares many clinical and histopathological     similarities with SBO after allogeneic HSCT. One hypothesis is that the first step leading to     SBO is lung epithelium injury. SBO is then identified as an alloimmune reaction with only one     clearly identified risk factor: extrathoracic chronic GVHD. Due to their anti-inflammatory     and immunomodulatory properties, recent data suggest that low-dose macrolides may be     effective at preventing SBO after lung transplants. This well-tolerated treatment may be     useful for preventing SBO after allogeneic HSCT.      The objective of this Phase 3 multicentre randomized, double-blinded, clinical trial is to     evaluate the efficacy of azithromycin in preventing BO syndrome after allogeneic HSCT in     patients with malignant hematological diseases.   "
101383|NCT01959087|"     This study aims to compare the results of colonic surgery performed by single and multiport     laparoscopy.   "
101384|NCT01959074|"     This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent     after urinary stone surgery.   "
101385|NCT01959061|"     To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer   "
101386|NCT01959048|"     Clostridium difficile has become one of the leading causes of hospital acquired infections,     and is associated with increased mortality. Patients with C. difficile associated disease     (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result     of earlier antibiotic usage. The current standard of care treatment for severe C. difficile,     which consists of antibiotics, does not restore the microbiota. Restoration of the normal     colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic     microbial population to a more 'normal'state and lead to cure.      A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic     megacolon. The management in this context is based on limited data, and for some the only     available option is sub-total colectomy.      Although FMT is by no means a new therapeutic modality, there is limited information on its     use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and     mortality associated with treatment of patients with severe CDAD, and because the evidence     supporting the current recommendations is weak and based upon the demonstration that FMT is     an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of     recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.      Patients with severe CDAD can be divided into two operational groups; those that have     diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through     colonoscopy for all patients because current data suggest that the overall success rate of     FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the     upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic     megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality),     intra-colonic FMT administration is the preferred alternative.   "
101387|NCT01959035|"     To obtain information on the safety, tolerability and effectiveness of aripiprazole     once-monthly in a manner consistent with its intended use in everyday clinical practice in     patients with schizophrenia who completed Study 14724A / NCT01795547.   "
101388|NCT01959022|"     This study will assess the effects of the medication doxazosin on sleep in men and women with     PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist     actigraphy.   "
101389|NCT01959009|"     Background:      Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency     oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure     fluctuation around a continuous distending pressure and therefore small tidal volume. Animal     studies showed that recruitment and maintenance of functional residual capacity (FRC) during     HFOV (open lung concept) could reduce lung injury.      Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using     oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with     recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a     rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation,     quicker weaning and shorter ventilation. This may be related to improved lung recruitment.     This has however to our knowledge not been tested in a clinical trial using modern     ventilators.      Purpose, aims:        -  To compare HFOV-sigh with HFOV-only and determine if there is a difference in          oxygenation expressed as a/A-ratio and/or stability of oxygenation expressed as          percentage time with oxygen saturation outside the reference range.        -  To provide information on feasibility and treatment effect of HFOV-sigh to assist          planning larger studies. We hypothesize that oxygenation is better during HFOV-sigh.      Methods:      Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will     be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4     alternating 1-hours periods (2-treatment, double crossover design, each patient being its own     control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV     will remain at pretrial settings. Outcome will be calculated from normal clinical parameters     including pulx-oximetry and transcutaneous monitoring of oxygen and carbon-dioxide partial     pressures.   "
101390|NCT01958996|"     R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's     lymphoma. In order to avoid central venous system insertion and reduce hospitalization time     in elderly patients, we developed an oral chemotherapy treatment:  OROCIEPtrial.      Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities.     The estimated two-years overall survival was 74%. The main haematological toxicity was     neutropenia.      This study is still ongoing to confirm recommended dose of oral anthracycline.   "
101391|NCT01958983|"     The purpose of this study is to determine if the effects of music therapy alter emotion and     cognition performances of individuals with mild to moderate dementia. The music therapy     intervention protocol is structured by drum improvisation, rhythm imitation, music cognition     and song discussion. Attentive listening and active participation of the music training     activities allow participants to utilize their focus of attention and comprehension of     informational texts. Music therapy intervention is proposed to provide positive stimulations     on emotion and cognitive functions of individuals with dementia. The results of the present     study will clarify relationship between the effect of music therapy and the neural substrate     of music therapy in anatomical and functional brain data obtained from MRI (fMRI).   "
101392|NCT01958970|"     This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745     or placebo in treating protein energy wasting (PEW) in patients receiving maintenance     hemodialysis (MHD).   "
101393|NCT01958957|"     The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the     treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.   "
101394|NCT01958944|"     Cystic Fibrosis is defined as a genetic disorder affecting approximately 100,000 individuals     worldwide. CF is caused by mutations in the CF Transmembrane Conductance Regulator (CFTR)     gene. CF patients are highly prone to environmental opportunistic bacterial infections     leading to prolonged and chronic lung infections. This results in reduction in the life     expectancy of CF patients due to excessive lung tissue destruction.      Nitric Oxide (NO) is a naturally produced antimicrobial agent which is part of the innate     immune defense system of the lung. Both in vitro and in vivo studies had shown clearly that     NO acts against a wide variety of microbes including drug resistant bacteria as well as     viruses and fungi. Building on a successful phase I safety trial, the team aims to develop a     combined drug-device strategy to combat lung infections caused by biofilm-forming bacteria.     Unlike other inhaled drugs, NO is also a smooth muscle relaxant and avoids the concomitant     bronchial constriction often associated with inhaled antibiotics. An added benefit of NO     therapy is its mucolytic activity. We suggest that the combine broad spectrum antimicrobial     activity, signaling and mucolytic properties of NO, delivered to the lungs of CF patients,     will be directed at reducing bacterial resistance, microbial burden and biofilms as well as     resulting in improved airway clearance of viscid sputum.      Primary Objectives: Assess the safety and the tolerability of NO intermittent inhalation     treatment in ≥10 years old CF subjects. Secondary Objective: Assess the improvement in forced     expiratory volume in 1 second (FEV1) before and after NO intermittent inhalation. Up to 10     subjects with Cystic Fibrosis will be enrolled into the study.      Treatment administration: The subjects will receive intermittent inhalation of NO in addition     to standard treatment for 10 working days (no NO treatment will be given to the subjects     during weekend days). The subjects will be asked to attend the CF clinic once a week for a     period of two weeks in order to evaluate the parameters related to the study. Oxygen (O2),     NO, nitrogen dioxide (NO2) and fraction of inspired oxygen (FiO2) delivered to the patient     will be continuously monitored.   "
101395|NCT01958931|"     A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis     of lung cancer.   "
101396|NCT01958918|"     This is a 12-month, phase IV, randomized, open label, multicenter study to compare efficacy     of 0.5 mg ranibizumab pro re nata treatment versus 2 mg aflibercept bimonthly intravitreal     injections on central retinal thickness (CRT) stability as measured by mean CRT fluctuations     between month 3 and month 6 of treatment by spectral domain optical coherence tomography     (SD-OCT) and explore functional outcomes up to month 12 in patients with neovascular (wet)     age-related macular degeneration (AMD). Approximately 500 patients will be randomized in     Europe.   "
101397|NCT01958905|"     The general objective of the study is to answer to the question: Is the current dose of AL     less efficacious in the severely malnourished compared to the non-severely malnourished     children, and is PK in cause? We aim to assess whether the current treatment dose is     adequate for children with severe acute malnutrition, and we hope results will guide further     recommendations for malaria treatment in this specific population.   "
101398|NCT01958892|"     The purpose of the study is to assess whether transurethral enucleation of prostate gives     better or equivalent outcomes compared to the gold standard of transurethral resection of the     prostate   "
101399|NCT01958879|"     The study aims to evaluate effectiveness of ringer injection with or without corticosteroid     during arthrocentesis of the temporomandibular joint in the treatment of internal derangement     of the temporomandibular joint (TMJ).   "
101400|NCT01958866|"     Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.      This study aims to investigate the efficacy and safety of Tinospora Crispa-extract product     compared with the acetaminophen. Total of 96 patients with body temperature between 37.8-38.5     without any signs of infections will be enrolled in this study. Patients will be randomly     divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr, Second     group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third group     will receive placebo twice daily.   "
101401|NCT01958853|"     The purpose of this open label study is to provide up to 24 active treatments of noninvasive     cortical electrostimulation therapy only to those fibromyalgia patients who experienced     inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201     (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol     as that used in active treatment arms of NPT-201. The study's primary outcome measure will be     the patient's change from baseline in self-reported 24-hour average pain intensity. The study     will provide active treatment to those participants who received sham therapy in NPT-201, and     will test whether or not additional therapy applications might further improve pain in those     participants who previously received active therapy, but did not achieve adequate pain     relief.   "
101402|NCT01958840|"     Following a small, open-label pilot study that yielded very promising results of BATD, the     current study will consist of a larger, randomized control trial (n=60) that will compare     BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement     in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In     addition, participants' adherence rates to each of the therapies and their maintenance of     clinical gains at a 1-month follow-up, will be examined.   "
101403|NCT01958827|"     The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after     dose escalation in Japanese subjects with Crohn's Disease.   "
101404|NCT01958814|"     randomized double-blind controlled study in parallel groups      Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.      During this administration, non invasive ventilation for the patient will be continued.   "
101405|NCT01958801|"     The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial     plexus blocks in the patients undergoing arthroscopic shoulder surgery.   "
101429|NCT01958476|"     1: SPECIFIC AIM I: To compare treatment options for neonatal abstinence syndrome (NAS) due to     in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS     requiring medications will be studied. Infants will be randomized to receive either morphine     or methadone. It is hypothesized that morphine treated infants will do better and require     fewer days in the hospital compared to methadone treated infants.      2. SPECIFIC AIM II: To evaluate the effects of NAS treatment on long-term neurodevelopmental     outcome. Infants will be evaluated with development testing at 18 months of age. It is     hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It     is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will     correlate with neurodevelopmental impairment at 18 months.      3: SPECIFIC AIM III: To determine if common genetic variations in the genes involving     narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all     infants and analyzed for differences in 3 key genes. This will then be correlated with     short-term and long-term outcomes.   "
113178|NCT01804530|"     The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated     dose/recommended Phase 2 dose, and efficacy of PLX7486.   "
101406|NCT01958788|"     Generalized Anxiety Disorder (GAD) is an anxiety disorder characterized by excessive and     uncontrollable worry. Our research group has developed a cognitive-behavioural treatment     (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that     arises from a set of negative beliefs about uncertainty and its consequences (Dugas &     Robichaud, 2007). This CBT protocol has demonstrated good efficacy over four previous     clinical trials: approximately 70% of participants fully remit from GAD following treatment     and maintain these gains over extended follow-up periods. These results, while positive, do     suggest that a substantial minority of individuals do not fully benefit from the existing     treatment protocol. Across our randomized clinical trials, individuals who do not achieve     diagnostic remission of GAD continue to endorse elevated levels of intolerance of     uncertainty. This suggests that the current CBT protocol does not effectively reduce     intolerance of uncertainty in some treated individuals. To address this, we have developed a     modified version of the original CBT protocol that targets intolerance of uncertainty more     directly. The goal of the current proposal is to determine whether this newly developed CBT     protocol with fewer components can deliver comparable or superior GAD symptom reduction. A     total of 7 participants with a primary diagnosis of GAD received the newly developed CBT     protocol over 12 weekly sessions. Measures of GAD symptoms, psychopathology, and intolerance     of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and     6-month follow-ups. The proposed study will provide information about the efficacy of this     new CBT protocol in reducing GAD symptoms.   "
101407|NCT01958775|"     1. To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study          A)        2. To assess whether GLP-2 affects the release of preformed chylomicrons (study B)   "
101408|NCT01958762|"     In the Somme region of France, cancer registry data showed an increasing incidence of oral     cancer. The Incidence Rates in Somme as compared to the national rates for Lip, Oral Cavity     and Pharynx Cancer were in 2010: 31,4/100 000 Standard population versus 18,2 /100 000 for     male and 8,2/100 000 versus 5,5/100 000 for female, disaster area where action to improve     early detection for smokers will be assessed. This target population consults late (as 70% of     oral cavity cancers are diagnosed at a late stage (T3 or T4). This project is an innovative     incentive strategy for screening among general practitioners based on unusual information     vectors (tobacconist, local media).      The main objective of this study is a screening of oral cavity cancers in tobacco users aged     30-75 years in the Somme region of France.   "
101409|NCT01958749|"     The current standard treatment for chronic tympanic membrane perforations (TMP) involves     having fat grafted from the patient and inserted into the ear, through the perforation, to     promote healing using the fat graft myringoplasty (FGM) technique. Platelet rich plasma (PRP)     has also been used to promote TMP healing and involves having the patient provide a blood     sample, which is processed to produce PRP and applied to the perforation. This prospective,     multi-centre study will evaluate whether combining both these techniques can improve the rate     of closure in patients with chronic TMP involving <50% of the membrane.      Patients will be randomized to receive either the standard FGM treatment or FGM treatment     with the addition of PRP. At 3 months postintervention a blinded observer will rate the     degree of TMP closure. Differences in closure rates between the 2 groups will be compared.   "
101410|NCT01958736|"     This pilot study intends to evaluate whether stroke patients can complete ballistic strength     exercises for thirty minutes, three times per week over a six week training period in     addition to their existing rehabilitation program.      It will evaluate whether using ballistic training principles, is superior in improving     mobility compared with usual care exercises to improve mobility and leg strength in stroke     patients.      In this study there will be 15 participants per group, a total of 30 participants. The     control group will receive usual care consistent with existing rehabilitation practice and     literature. The experimental group will perform task specific strength training in a     ballistic fashion.   "
101411|NCT01958723|"     The emergence of electronic documentation has led to multiple new challenges for physicians.     Despite positive expectations, many physicians have received electronic health systems with     mixed results. Review of current literature has identified the following reasons for concern:     increased time required for documentation, deteriorating quality of notes, mindless use of     copy-and-paste functions, and fragmentation of clinical work from poorly designed computing     workflows. The study of template use has not been done in a large scale or with clear outcome     measurements. The purpose of this study is to examine the effects of Problem Specific     Templates on quality, accuracy, and efficiency of physician documentation practices.   "
101412|NCT01958710|"     Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.   "
101413|NCT01958697|"     Esophagectomy for cancer is often accompanied with severe preoperative weight loss. Body Mass     Index (BMI) values are age-independent and the same for both sexes. From the perspective that     these two parameters should actually be taken into account too, we developed a model to     calculate age-gender specific BMI-percentiles (AG-BMI) and tested this model in relation to     survival outcome after esophagectomy for cancer.   "
101414|NCT01958684|"     To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to     Cu-IUD over the first 6 months.   "
101415|NCT01958671|"     This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the     treatment of subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on     diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week     placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase     B). The primary hypothesis of the trial is that at Week 26, the mean reduction from baseline     in hemoglobin A1c (HbA1c) for 15 mg ertugliflozin is greater than that for placebo.   "
101416|NCT01958645|"     A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single     ascending doses in healthy male.   "
101417|NCT01958632|"     The actual study should provide a first direct comparison between results after     reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard     methods of nerve transplantation and direct nerve suture.   "
101418|NCT01958619|"     A healthy volunteer study to characterise the exposure of the two study medications,     following administration of OZ439 + TPGS granules with piperaquine phosphate granules     (intended for children) and with piperaquine phosphate tablets (intended for adults).     Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.   "
101420|NCT01958593|"     This small (pilot) study is designed to provide information on whether the combination of     psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress     disorder (PTSD). The researchers will use the results of this study to design more studies of     this treatment. The study compares a comparator and a full dose. For each session, there will     be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the size of the     initial dose. The study will measure symptoms of PTSD, depression, general psychological     well-being, sleep quality, feelings that the self or world is unreal (dissociation),     potentially positive effects of surviving traumatic events and cognitive function (thinking,     memory and attention). People experiencing pain or tinnitus (ringing in the ears) will record     their symptoms throughout the study. Seven people will be randomly (by chance) assigned to     receive full-dose MDMA and five will be randomly assigned to receive a comparator. There will     be three preparatory psychotherapy sessions before the first experimental session, and     subjects will have supportive or integrative sessions after each MDMA-assisted     psychotherapy session. Subjects will meet with a male and female psychotherapist for all     experimental sessions and for sessions before and after each experimental session. Subjects     who received comparator can enroll in Stage 2, where they will have three open-label     MDMA-assisted psychotherapy sessions, meaning everyone will know they are receiving an active     dose of MDMA. Subjects receiving full dose in Stage 1 will have a third experimental     session.. Symptoms of PTSD and other symptoms will be measured again at least 12 months after     each subject has started the study.   "
101421|NCT01958580|"     This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy     in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in     chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high energy x rays to kill tumor cells. Giving combination     chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.   "
101422|NCT01958567|"     The main purpose of this study is to describe the optical coherence tomography (OCT) findings     in eyes with scleral inflammation and to differentiate cases with anterior scleritis from     those with episcleritis and normal controls.   "
101423|NCT01958554|"     Intimate partner violence (IPV) against women have negative mental health consequences for     survivors; interventions designed to improve survivors' depressive symptoms and health status     are limited.Present study evaluate the effectiveness of an integrated intervention in     reducing intimate partner violence (IPV) improving health status.   "
101424|NCT01958541|"     This study investigates the impact of brief behavioral insomnia treatment on depressive     symptoms among military veterans.   "
101425|NCT01958528|"     This is a prospective study to collect blood and bone marrow samples from patients with SM     and MGUS. About 100 subjects will be enrolled at the University of Pennsylvania and followed     for 2 years. The primary objective of this study is to evaluate CMMCs as a biomarker to     detect patients at high risk of progression to multiple myeloma in patients with MGUS and     SMM.   "
101426|NCT01958515|"     The primary purpose of this research is to investigate anti-tumor immune responses in     patients undergoing chemotherapy and radiation for Head and Neck Cancers.      Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in     changes in the tumor microenvironment. We hypothesize that these changes during daily     fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune     responses.      Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy     in the presence or absence of lymphopenia.        -  This study will determine whether specific anti-tumor immune responses (Specific          Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation          treatment for Head and Neck Cancers.        -  This study will evaluate the presence or absence of HPV (human papillomavirus) specific          immune responses before, during, and after treatment for Head and Neck Cancers.        -  This study will also evaluate whether decreased white blood cell counts may affect          development of immune responses in Head and Neck cancer patients undergoing treatment.      Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you     are older than 18 years of age, capable of providing informed consent, have a life expectancy     of greater than 4 months, and have a good performance status.      You are eligible irregardless of your HPV positive or negative status. People with HPV     positive (human papillomavirus associated) head and neck cancer may join. People with HPV     negative head and neck cancer may also join.   "
101427|NCT01958502|"     Because the rate of non union of long bone in lower extremities specially in tibia in this     two last decade due to malnutrition and smoking and other risk factors was increased, so many     patient in our country suffer from non union. On the other hand it seems that the use of the     mesenchymal stem cells can irritate the union rate. Also for better result we used the     mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive     effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is     useful in filling the gap in non union site and irritate the union rate.      Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure.     Then the investigators will follow the patient with monthly radiography and evaluate the     callus volume and clinical union and any side effect of this treatment. Clinical union     consider to relief pain in non union site and be stable in examination.   "
101428|NCT01958489|"     The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels     in the blood when both drugs are taken at the same time. The study will also assess how well     the body handles evacetrapib and pravastatin when given at the same time.      This study has two periods in fixed order. Each participant will enroll in both periods. This     study will last approximately 25 days, not including screening.   "
101430|NCT01958463|"     Recent data have demonstrated beneficial health outcomes of microbiota transplantation for     the treatment of Clostridium Difficile infection.      The investigators propose testing whether fecal transplantation from a healthy donor can lead     to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.   "
101431|NCT01958450|"     Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser     treatment.   "
114086|NCT01792583|"     The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the     pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.   "
101432|NCT01958437|"     Remembering how to travel from one location to another is critical in everyday life, yet this     vital ability declines with normal aging and can be further affected by conditions that     disproportionately affect the elderly, such as vision loss or progressive dementia. Human and     animal research has shown that two distinct memory systems interact during navigation. The     first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of     key features or landmarks to develop and use a mental map of the environment. This approach     involves brain regions that are critical for new learning and memory but that decline with     age. The second, referred to as egocentric navigation, is inflexible and relies on habit     memories that link specific features with specific directions. This approach relies on brain     regions that are critical for automatic responses and that are relatively unaffected by     age.      The main problem is that allocentric navigation declines with age and is accompanied     increased dependence on egocentric navigation. This change increases the risk of becoming     disoriented or lost when traveling in unfamiliar areas or even when traveling new routes in     familiar areas. Therefore, the main goal of this project is to examine whether non-invasive     brain stimulation, specifically transcranial direct current stimulation, can improve     allocentric navigation in healthy older adults and patients with mild cognitive impairment.      Participants will complete two functional magnetic resonance imaging sessions while learning     new environments. Before one of these sessions, participants will receive active brain     stimulation over the parietal cortex. Before the other session, participants will receive     sham brain stimulation over the parietal cortex. The effects of this stimulation will be     evaluated using both an allocentric and an egocentric memory test. Physiologic effects will     be evaluated using both task-based and resting-state MRI.   "
101433|NCT01958424|"     The purpose of this study is to examine the effect of metabolic syndrome in over-weight women     on IVF treatment outcomes.   "
101434|NCT01958411|"     -  Vascular inflammation is a key factor in both the pathogenesis and outcome of          atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a          promising tool for identifying and quantifying vascular inflammation within          atherosclerotic plaques.        -  Non-alcoholic fatty liver disease (NAFLD) is closely associated with many          cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation          using computed tomography (CT).        -  Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is          an independent marker of cardiovascular events in the general population.        -  Therefore, the purpose of this investigators study is to compare the NAFLD severity and          EAT volume with FDG uptake measured by PET/CT.   "
101435|NCT01958398|"     Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll     and PartyPlanner among university government members at two universities in Stockholm,     Sweden. The design is a three-armed randomized controlled design, and outcomes are measured     in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation     and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time     registration of alcohol consumption and giving feedback of estimated blood alcohol     concentration levels. Both apps inform and warn the user when the estimated alcohol level is     above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally     provides the possibility of simulating and planning an alcohol consumption event in advance     and later on comparing it with the real time registration at the event.      Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are     randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner and     3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction     with the app assigned to them gathered after 7 weeks.      The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions     will reduce their alcohol use to a larger extent than the control group at follow-up compared     to the baseline level. 2. The addition of the possibility to plan events beforehand     (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time     use (Promillekoll).   "
101436|NCT01958385|"     This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled     study intended to evaluate the safety and efficacy of treating obese patients with the     placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as     compared to a sham procedure followed by the same diet and exercise plan. Subjects will be     randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or     the sham procedure followed by diet and exercise. After un-blinding at 12 months     post-treatment, sham patients can choose to have the treatment procedure as well.   "
101437|NCT01958372|"     This phase I trial studies the side effects of soy isoflavones when given together with     radiation therapy and chemotherapy in treating patients with stage IIIA-IIIB non-small cell     lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in     chemotherapy, such as cisplatin, pemetrexed sodium, and etoposide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Soy isoflavones may help radiation therapy, cisplatin, pemetrexed sodium, and     etoposide work better by making tumor cells more sensitive to the drug. Soy isoflavones may     also protect normal cells from the side effects of radiation therapy and chemotherapy.   "
101438|NCT01958359|"     Objectives: The study evaluates the efficacy of two automated telephony, also known as,     Interactive Voice Recognition (IVR) interventions, Short IVR and Therapeutic IVR. The Short     IVR works as an interactive alcohol diary where the user is contacted once a week for four     weeks to register their alcohol consumption during the preceding week. The user is given     feedback on changes in alcohol consumption compared to last week. The Therapeutic IVR     contacts the user once a week for four weeks and is also available for user-initiated calls     24/7 during this four-week period. The Therapeutic IVR allows the user to traverse a menu     where the user chooses among listening to vignettes and doing exercises with the purpose of     looking at alcohol consumption and exploring ways of coping with it.      Method: The design is a three-armed randomized controlled design, and outcomes are measured     in terms of changes in problematic alcohol use at follow up six months after study initiation     and baseline data gathering. Participants with problematic alcohol use (AUDIT >7 for men and     >5 for women) are randomized into one of three groups: 1. Short IVR, 2. Therapeutic IVR and     3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction     with the intervention are assessed after 6 months.      The primary hypothesis for this study is that having access to one of the two IVR     interventions will lead to a greater reduction of problematic alcohol use compared to     controls who undergo only screening and follow-up assessment. The secondary hypothesis is     that having access to either Short IVR or Therapeutic IVR leads to comparable reductions in     risky drinking.   "
101728|NCT01954576|"     This pilot phase II trial studies how well Novocure's Tumor Treating Electric Fields     (NovoTTF) therapy works in treating patients with recurrent glioblastoma multiforme. NovoTTF     therapy uses a low intensity electric current to kill tumor cells. NovoTTF therapy may be     effective treatment for brain cancer.   "
101441|NCT01958320|"     The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA)     treatment approaches: 1) an early treatment approach or 2) a conservative approach. For     the purposes of the study infants will be enrolled if they are delivered before 28 weeks     gestation and have a moderate/large PDA present at 5-7 days after birth.      The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease     the time needed for assisted respiratory support, diuretic therapy, and gavage feeding     assistance, in addition to decreasing the incidence of ductus ligations or need for future     outpatient cardiology follow-up appointments. The investigators hypothesize that one or more     of these benefits will occur without an increase in the time taken to achieve full enteral     feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal     perforations (SIP).The investigators will be comparing the effectiveness of early     pharmacologic treatment with a control group of conservatively managed infants who will only     receive treatment if they meet specific criteria for rescue treatment.   "
101442|NCT01958307|"     Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal     state of Germany, targeting maternal and fetal health. The objective of this trial is to     evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity     and weight monitoring during pregnancy. The intervention comprises 4 individual counseling     sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary     outcomes are pregnancy and obstetric complications like gestational diabetes and rate of     caesarean sections as well as offspring health.      The lifestyle intervention program is adapted to the German health care system to allow an     immediate implementation after successful evaluation.   "
101443|NCT01958294|"     The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System     (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who     are candidates for Carotid Artery Stenting (CAS). It is a prospective, single arm study in     which a maximum of 30 study subjects, and a run-in enrollment of up to 10 subjects will be     followed immediately post-op and at 30 days.   "
101444|NCT01958281|"     This study will evaluate the safety, tolerability and antiviral efficacy of sofosbuvir (SOF)     with ribavirin (RBV) in participants with GT 1 and 3 and ledipasvir (LDV)/SOF in participants     with genotype 1 and 4 HCV infection who have chronic renal insufficiency (impaired kidney     function).      Approximately 35 subjects with severe renal insufficiency (not on dialysis) will be enrolled     in 3 cohorts.        -  Cohort 1 (GT 1 or 3): 10 subjects will receive SOF 200 mg + RBV 200 mg once daily for 24          weeks.        -  Cohort 2 (GT 1 or 3): Following review of safety, efficacy and pharmacokinetics (PK)          data through post-treatment Week 4 of Cohort 1, 10 additional subjects will receive SOF          400 mg + RBV 200 mg once daily for 24 weeks.        -  Cohort 3 (GT 1 or 4): Following review of safety and available PK data through Week 12          of Cohort 2, 15 additional subjects will receive LDV/SOF 90/400 mg once daily for 12          weeks.   "
101445|NCT01958268|"     Establishment of a questionnaire in German to determine in a structured and quantifiable     manner the quality of life of patients with dysphagia.   "
101446|NCT01958255|"     The aim of this project was to provide tobacco cessation services to the women at the     community level at their door steps and thus establish a model community based tobacco     cessation programme which could be replicated in other communities and could be taken up by     National Tobacco Control Programme (NTCP), in future.   "
101447|NCT01958242|"     Blood transfusions after pediatric heart surgery is a relatively common practice occurring in     up to 46% of patients, however its use has been associated with increased morbidity. In the     pediatric population undergoing heart surgery transfusion of homologous blood is usually     required due to the mismatch between the priming volume of the cardiopulmonary bypass circuit     and the patients own blood volume. Several strategies have been proposed in order to minimize     the use of blood products. The effect of pre-operative harvest of fresh whole blood in the     adult population has shown a beneficial platelet protective effect, however concerns have     been risen that the amount of volume needed in order to sequester a significant amount of     platelets would be prohibit ally high in a cardiac surgical patient. Fresh blood harvesting     has not been evaluated in the pediatric population.      The purpose of the present study would be to evaluate the safety and efficacy of     pre-operative blood harvesting in the pediatric population undergoing open heart surgery.     Fresh whole blood will be harvested from the patient prior to the initiation of     cardiopulmonary bypass and will be returned to the patient after the discontinuation of CPB     prior to the administration of prominent. Parameters that will be evaluated will include,     patient characteristic, operative and post-operative parameters, coagulation profiles and the     use of postoperative blood products.   "
101448|NCT01958229|"     This study is designed to support the optimal use of telbivudine by providing data to refine     our understanding of telbivudine efficacy and resistance in real life clinical setting in     patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR     negativity.   "
101729|NCT01954563|"     Boost vaccinations sometimes have no effect because the body has got used to the vaccine and     no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised     MVA85A (a candidate tuberculosis vaccine) followed by a boost MVA85A intradermal vaccination     (or vice versa) avoids this and increases the immune response to vaccination.   "
101503|NCT01957501|"     Depression and bipolar disorder are major public health concerns for adolescents today.     Teenage depression and bipolar disorder are associated with social isolation, family stress,     school failure, substance abuse and suicide. Screening for depression and bipolar disorder so     that treatment can be started early in the course of illness is an urgent public health     priority. Many teens with bipolar disorder are incorrectly diagnosed as having unipolar     depression. It is critical that adolescents receive proper screening and assessment that     leads to an accurate diagnosis and treatment. An efficient, cost-effective, blood-based     screening program could be performed on an annual or semi-annual basis to potentially detect     depression and then differentiate between unipolar and bipolar depression. If this type of     screening were able to detect a significant percentage of teens with depression or bipolar     disorder, the positive impact on U.S. public health would be substantial. The purpose of this     study is to conduct a pilot study to assess the probability of detecting adolescent unipolar     and bipolar depression through blood samples.   "
101504|NCT01957488|"     The aim of the current investigation is to investigate the performance of two new 1-piece     ostomy products   "
101450|NCT01958203|"     Study Title:Assessment of Adherence to Guidelines for Thromboprophylaxis in a Tertiary United     Arab Emirates (UAE) hospital      Study Site: Al Qassimi Hospital, United Arab Emirates      Study Objectives:      The primary objective of this study is assessment of appropriateness of VTE prophylaxis     administered to critically ill and surgical patients for whom pharmacologic treatment is     indicated according to the American College of Chest Physicians (ACCP) 2012 guidelines.      The secondary objective is to:      1.Identify some causes of inadequate VTE prophylaxis in different patient populations, such     as prescribing problems and errors at the level of administration.      Study Design: Cross sectional retrospective observational study      Sample size: Approximately 400      Study Population:      Inclusion criteria      Patients who meet the following criteria will be included:        1. Patients aged 18 and above.        2. Patients admitted to any of the critical care units, or the general or orthopaedic          surgical wards.        3. Patients who have been in hospital more than 24 hours.        4. Caprini score > 1 (see procedure)      Exclusion criteria      Patients with any of the following criteria will be excluded:        1. Patients who have been admitted to a critical care unit and transferred out to a non          surgical unit within 24 hours of admission.        2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis          or treatment, such as atrial fibrillation and prosthetic heart valves.      Study Outcome Measurements:      The main outcome measure of interest is to determine the proportion of patients who have     received inappropriate or inadequate VTE prophylaxis considering their calculated risk factor     compared to the recommended prophylactic measures for that risk.      Secondary outcome measures are to identify whether there is inadequate VTE prophylaxis     because of medication errors such as missed doses or wrong doses given.      Study Duration: 4 months      Statistical Analysis Data was entered into Microsoft Excel® and subsequently checked to     ensure accurate data entry and correct any errors. It was subsequently exported into SPSS     version 20 where it will be analysed.Quantitative data such as age was expressed mean (±     standard deviation). Categorical data such as gender, risk factors for bleeding, type of     mechanical and pharmacologic prophylaxis, missed doses and wrong doses were expressed as     number and percentage of population.The student's t-test was used to analyse parametric data.     The Pearson Chi-Square Test and Wilcoxon Rank sum test were used to analyse non parametric     data. Simple and multiple logistic regression analysis was done to identify factors that are     associated with inappropriate VTE prophylaxis. Factors that were included in the analysis     included: age, type of admission (medical or surgical), area of admission (critical care,     general surgery, orthopaedic surgery), Caprini score, and inappropriate VTE prophylaxis as     the outcome. A p-value of less than 0.05 was be considered statistically significant.   "
101451|NCT01958190|"     In this study we compare long term renal function in liver transplantation recipients treated     with standard dose extended-release tacrolimus alone and recipients treated with a     combination of low dose extended-release tacrolimus and low dose sirolimus. The hypothesis is     that the patients treated with the combination have better long term renal function than the     patients treated with standard dose tacrolimus alone.   "
101452|NCT01958177|"     Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many     diseases and presents with symptoms of an inability to coordinate balance, gait, extremity     and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria,     dysdiadochokinesia, dysarthria and ataxia of stance and gait. Deficits are observed with     movements on the same side of the body as the lesion (ipsilaterally).   "
101453|NCT01958164|"     This is a multicentre, open-label, randomised, phase III study designed to evaluate the     efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD   "
101454|NCT01958151|"     Colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis     and treatment of a wide range of gastrointestinal problems. It is often viewed as an invasive     procedure with the potential for embarrassment, discomfort, and worry. Such fears can result     in anxiety that may decrease the tolerance and cooperation of the patient, limit the success     of the procedure, and increase the likelihood of complications. Therefore, colonoscopy is     frequently performed under sedation. The anxiety level of the patient before the procedure     may increase the requirement for sedation. It is important for the anesthesiologist to     predict the effective dosages of sedation before the procedure to ensure rapid and     comfortable sedation as well as prompt recovery and discharge of the patient.      This prospective cohort study is planned to evaluate the effects of pre-procedural anxiety     level on the dose of propofol needed for patient and surgeon satisfaction during colonoscopy.   "
101455|NCT01958138|"     The study will be done in pediatric population by comparing two techniques of Laryngeal Mask     Airway (LMA) removal under the deep anesthesia.      The both study techniques will be compared on the basis of smooth Laryngeal Mask Airway     removal, emergence time and the duration of recovery room stay.   "
101456|NCT01958125|"     The study will look at a non-invasive treatment for people suffering with chronic and     episodic headaches. Study subjects will be randomized to an active treatment or an in-active     treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active     treatment for an additional 2 weeks.   "
101457|NCT01958112|"     This research study is evaluating the combination of two drugs called GSK1120212 (trametinib)     and GSK2141795 as a possible treatment for recurrent or persistent cervical cancer.     Trametinib and GSK2141795 are drugs that may stop cancer cells from growing. Trametinib is a     MEK inhibitor - it blocks a protein called MEK that is commonly overactive in tumor cells.     GSK2141795 is an AKT inhibitor which blocks a pathway in cancer cells that is commonly     overactive in tumor cells called the PI3kinase pathway. In this research study, the     investigator is looking to see whether the combination of Trametinib and GSK2141795 is useful     in treating recurrent and persistent cervical cancer.      Additionally, the investigator is looking to see if participants whose tumors contain a     particular genetic make-up will have better response to combination trametinib and     GSK2141795. Participants' tumors will be tested for mutations in genes which could make some     cancers more susceptible to trametinib and GSK2141795.   "
101458|NCT01958099|"     The purpose of this project is to compare the costs, ability to effectively screen and     distribute relevant safety information, and assess products purchased and behavior changed by     families after meeting with an injury prevention specialist compared to using a computerized     emergency department kiosk. There will be a significantly greater reported practice of safety     behaviors by families who visit a pediatric emergency department after using a computerized     kiosk for injury screening and providing tailored recommendations than when the prevention     information is provided by an injury prevention specialist.   "
101480|NCT01957800|"     A randomized controlled trial comparing the effects of the social-enabled internet weight     loss and diet change intervention with the delayed treatment group for 3 months. We will     study the effect of adding social interactions and supports to an Internet weight loss and     diet change intervention. The website intervention will have action planning with social     interactions and support features for sharing, reusing, recommending, and discussing     strategies for improving habits. We hypothesize that the intervention group with access to     the website will lose more weight than the delayed treatment group after three months.   "
101481|NCT01957787|"     The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used     to treat tumors in patients with pulmonary metastatic disease. This study is to enroll     patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less     than or equal to 3.5cm. Patients will be followed 24 months post their cryoablation     procedure.   "
101459|NCT01958086|"     The investigators objective is to run human clinical trials in which brain activity recorded     through a brain-chip implanted in the human brain can be used to provide novel     communication capabilities to severely paralyzed individuals by allowing direct brain-control     of a computer interface. A prospective, longitudinal, single-arm early feasibility study will     be used to examine the safety and effectiveness of using a neural communication system to     control a simple computer interface and a tablet computer. Initial brain control training     will occur in simplified computer environments, however, the ultimate objective of the     clinical trial is to allow the human patient autonomous control over the Google Android     tablet operating system. Tablet computers offer a balance of ease of use and functionality     that should facilitate fusion with the BMI. The tablet interface could potentially allow the     patient population to make a phone call, manage personal finances, watch movies, paint     pictures, play videogames, program applications, and interact with a variety of smart     devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic     limbs and smart cars. Brain control of tablet computers has the potential to greatly improve     the quality of life of severely paralyzed individuals. Two subjects will be enrolled, each     implanted with the NCS for a period of 53 weeks. The study is expected to take two years in     total.   "
101460|NCT01958073|"     The investigators would like to know if the use of vaginally applied estrogen can prevent the     problem of repeated urinary tract infections (UTI) in women who have gone through menopause.     The investigators will use two forms of vaginal estrogen that are available by prescription     (a ring and a cream) and compare their efficacy to that of a placebo (without any active     ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs     altogether and also the number of UTIs each group experiences over a 6 month period. After 6     months, all subjects will receive vaginal estrogen and the women on the non-active treatment     will be randomized to either the estrogen ring or cream. The investigators will then be able     to compare the number of UTIs on and off active vaginal estrogen treatment within those     subjects who started on the placebo. The investigators are also going to look at quality of     life before and during treatment using questionnaires and whether subjects stop using the     treatments or do not use them as directed (compliance).   "
101461|NCT01958060|"     Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following     intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of     the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination     of the bioavailability of subcutaneous injections of BI 1034020   "
101462|NCT01958047|"     This study investigates how ASP3652 is taken up, broken down, and distributed through the     body and excreted in individuals of different races. The study also investigates levels of     biochemical markers in the bloodstream, and determines how safe the study drug is and how     well it is tolerated after dosing. A further aim is to look at how the processes of     metabolism, distribution and excretion of the study drug are possibly altered by the daily     diet of the volunteers taking part.   "
101463|NCT01958034|"     In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment     elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial     infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a     range of parameters with prognostic importance in cardiovascular disease: lipids,     inflammation, oxidative stress and heart function.      Following inclusion of 8 individuals and as of February 12, 2014: Due to intolerance to     bilberry placebo powder we have amended to the protocoll that the trial design is changed     from blinded to open and that the bilberry arm of the trial carries on in an open design and     that the control group will receive no dietary supplement.   "
101464|NCT01958021|"     This is a multi-center, randomized, double-blinded, placebo controlled trial.   "
101465|NCT01958008|"     The main objective of the current trial is to investigate safety, tolerability and     pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.   "
101466|NCT01957995|"     This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel     lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy,     such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing.   "
101467|NCT01957969|"     The aim of this observational study is to evaluate the utilization in the clinical practice,     effectiveness, explantation and re-intervention rate, complications and adverse events of     InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal     incontinence.      This study will provide additional data about safety and effectiveness of the usage of     InterStim system in fecal incontinence environment and at the same time will confirm that     results from clinical trials can be transposed to clinical practice.   "
101468|NCT01957956|"     This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with     newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with     tumor proteins may help the body build an effective immune response to kill tumor cells.     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine     therapy and temozolomide may be an effective treatment for glioblastoma.   "
101469|NCT01957943|"     The study Aims to investigate the possible beneficial impact of peri-operative or     post-operative administration of Omega 3 enriched lipid emulsions on recipients for living     donor liver transplantation.   "
101470|NCT01957930|"     We aim to investigate the relationship between skin microvascular function and the first     hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized     during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard     insulin treatment (ST).   "
101520|NCT01957280|"     The purpose of this study is to assess the PK, safety, and tolerability of patritumab     produced by a new manufacturing process (denoted as Process 2 patritumab). The data from     this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow     for any dose adjustments, if needed, and to bridge data from studies previously conducted     with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The     hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be     comparable to those of Process 1 patritumab.   "
101471|NCT01957917|"     The importance of good nutrition and food security among people living with HIV infection     (PLHIV) is widely recognized. In resource-constrained settings, food insecurity is     increasingly recognized as an important barrier to retention in care and adherence to     antiretroviral therapy (ART). However, there are few studies demonstrating that food and     nutrition assistance programs can improve HIV-related outcomes. This study will address this     gap by comparing the effectiveness of three models for short-term support for PLHIV. Food     insecure women and men on ART will be randomized into one of three groups: 1) nutrition     assessment and counseling (NAC) alone, 2) NAC plus food assistance, or 3) NAC plus cash     transfers. The investigators will compare the effect of the three approaches on ART adherence     and retention in care after 6 and 12 months of follow-up. The investigators hypothesize that     NAC plus short-term support in the form of food or cash assistance will result in better     adherence to ART and retention in care than NAC alone, and that the effects of NAC plus food     assistance will be the same as NAC plus cash assistance. The results from the study will     provide evidence about which assistance modalities for PLHIV work best to improve ART     adherence and retention in care, and under what conditions. This study will be conducted in     Shinyanga Region, Tanzania, where approximately 17 percent of households have poor or     borderline food consumption and 7.4 percent of people are living with HIV infection.   "
101472|NCT01957904|"     The study is designed to confirm the acute safety and performance of the ArterX® Surgical     Sealant as a hemostatic agent. The study will collect data in support of publications and     future product labeling revisions, to provide additional clinical information on use and     further details regarding product safety.   "
101473|NCT01957891|"     The purpose of the study is to assess the effect of progressive, incremental hypoxia at     multiple wavelengths of light.   "
101474|NCT01957878|"     Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix     vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell     carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination     with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The     therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine     targets these HPV infected women with normal or mild cervical cellular dyskaryosis as     detectable infections with oncogenic potential.      This will be a double-blind, randomised, placebo-controlled, parallel group study assessing     the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).      ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites     as a vaccine adjuvant.      The population proposed for this study represents an otherwise healthy female population who     are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic     vaccine has been shown in the ongoing Phase I study, and the proposed population may in     theory derive benefit from this vaccine.   "
101475|NCT01957865|"     Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The     Wisepill Study).   "
101476|NCT01957852|"     Introduction      Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive     surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy     (HIPEC) performed at the time of surgery. It is considered a high risk procedure and     post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote     intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to     control the bleeding will be necessary. Major causes of bleeding are : radical resection,     extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.      To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of     these is the liberal use of FloSeal, but there is no data in this particular field of     interest. Over the last 18 months, the investigators have started to use FloSeal in all their     cases with large PC and they have observed a dramatic reduction in the rate of reoperation     for bleeding and probably secondarily, in the use of blood products, but this has not been     measured.      Hypothesis      FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.      Primary objective      To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC     procedure in the treatment of PC.      Secondary objectives        -  To evaluate if the use of FloSeal can reduce operative blood loss.        -  To evaluate if the use of FloSeal can reduce the need of blood products after CRS and          HIPEC procedure.        -  To evaluate if the use of FloSeal can have an impact on other common surgical          complications (which can be indirectly bleeding related).        -  To evaluate if the use of FloSeal can have an impact on length of hospital stay.   "
101477|NCT01957839|"     the investigators examined the hypothesis that hyperprolactinemia may alter uterin,     endometrial and intraovarian blood flow and may contribute to increased infertility by     another way.   "
101478|NCT01957826|"     The purpose of this study is to assess the safety, the feasibility and the efficacy of     transendocardial injection of bone marrow-derived mesenchymal stem cells (MSCs) in patients     with dilated idiopathic cardiomyopathy.   "
101479|NCT01957813|"     -Purpose: To develop and evaluate an intervention designed to improve consistent     contraceptive use and dual method use in particular, among female sex workers (FSWs) in Rift     Valley Province in Kenya.      Design: A qualitative descriptive study will be conducted to develop the intervention. A     quasi-experimental, non-randomized, two-group, pre-/post-intervention design will be used to     evaluate the intervention.      Study Population: FSWs living in Naivasha, Gilgil, and Nanyuki, Rift Valley Province.      Study Duration: Phase I - 3 months Phase II - 12 months Objectives: Develop an intervention     designed to increase contraceptive use among FSWs by incorporating formative data and     behavioral theory and by involving the target audience and service providers in the     development of the intervention.      Examine the effectiveness of the intervention at increasing non-barrier modern contraceptive     use and dual method use among FSWs.      Assess the feasibility and acceptability of the intervention, on the parts of both the     clients (FSW) and service providers.      Estimate the unit cost to provide these services to one client. Study Site: Rift Valley     Province, Kenya   "
101763|NCT01954121|"     To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine     Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese     population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset     Seizures (POS).   "
101511|NCT01957397|"     To investigate the performance and safety of the three 2-piece convex ostomy appliances   "
101482|NCT01957774|"     The purpose of this study is to test the experimental drug THR-18 given together with the     drug tissue plasminogen activator for the treatment of stroke. Tissue plasminogen activator     is also called tPA.      Strokes often result from blockade of blood supply caused by blood clots forming within the     blood vessel feeding the brain. Such strokes are called Ischemic strokes. Treatment of     these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before     further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when     it is injected into a vein shortly after the stroke starts. However, along with breaking up     the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding.     THR-18, the drug tested in this study, is meant to bind to tPA and reduce its adverse effects     without stopping tPA's breaking up of the blocking blood clot.      The primary purpose of this study is to evaluate the safety of THR-18 in acute ischemic     stroke patients who are treated in parallel with tPA. Another purpose of this study is to     investigate levels of THR-18 and tPA in the blood stream at different time points after they     are injected, at the same time, into a vein. In addition, this study will measure tPA's     effect on blood clot dissolution when tPA is given with and without THR-18. The study will     also study the effect THR-18 may have on signals of brain damage that can be found in the     blood after stroke: these signals of brain damage are small proteins called S100B and matrix     metalloproteinase (MMP)-9. These proteins are released into the blood stream when the brain     is injured.      The safety evaluation of THR-18 in this study will be done in comparison to placebo. Placebo     is a drug that looks exactly like THR-18 but has no activity. Three doses of THR-18 will be     tested, one after the other, in three groups of patients. In each group, some patients will     receive THR-18 and some will receive placebo. This clinical study will be conducted only at     one hospital in the Ukraine. In total, 30 patients are planned to participate in this study.     These patients will be in the hospital for at least 3 days after receiving the study     treatment. Then, about 1 month later, they will be invited for a last follow-up visit.   "
101483|NCT01957761|"     Objectives:        1. Describe the molecular epidemiology of Clostridium Difficile infection in children in          the Chicago area.        2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection          secondary to particular endemic strains in children.        3. Define the risk factors for recurrent and community-associated Clostridium Difficile          infection in children.   "
101484|NCT01957748|"     CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the     effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in     care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary     care clinics.   "
101485|NCT01957735|"     This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to     examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous     intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with     chemotherapy (treatment Arm 2) in patients with solid tumors.   "
101486|NCT01957722|"     This study is to NOVOCART 3D relative to Microfracture for the treatment of knee cartilage     defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.   "
101487|NCT01957709|"     This pilot clinical trial studies the effect of recombinant interferon gamma on tissue in     treating patients with soft tissue sarcoma. Interferon gamma may interfere with the growth of     tumor cells.   "
101488|NCT01957696|"     Several studies have shown acceptable results after Pancreas Transplantation (PTx) by     substituting ATG with basiliximab, which is considered to convey a considerably lower number     of adverse events. However, our experiences with ATG in PTx (introduced in 2004) are good,     and our presumably gentle way of administrating the drug - directed by T-cell counts - is in     fact unique. The potential advantages of reducing the overall corticosteroid (CS) load is     obvious, as CS is a well-known pro-diabetic agent and causes severe long term adverse     effects.      On this background, the investigators have very recently reduced our CS dosing (in the     routine protocol) to a level corresponding to our Kidney Tx protocol (valid since 2009).      Thus, the investigators intend to prospectively investigate a single PTx cohort with the     reduced CS immunosuppressive protocol by an observational study design, and compare with     previous (historical) cohorts, who have received high dose CS.      Study hypotheses: i) Low-dose CS is as effective as high-dose corticosteroids with regards to     efficacy/rejections; ii) The rate of surgical and infectious complications will be similar or     lower in the low-dose group; iii) PTx rejection surveillance by DD (duodenoduodeno-stomy) and     EUSPB (Endoscopic Ultra-Sound guided Pancreas Biopsies) is superior to traditional rejection     surveillance; iv) Patient and graft survival is similar in the two groups   "
101489|NCT01957683|"     The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of     Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction     with embolization coils.   "
101490|NCT01957670|"     The study will assess the safety, tolerability and feasibility of Lacrima investigational     medical device to treat dry eye patients   "
101491|NCT01957657|"     The objective of the trial is to investigate the effect of different degrees of renal     impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir     after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and     faldaprevir on day 4.   "
101492|NCT01957644|"     To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of     volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS)     or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell     transplant   "
101493|NCT01957631|"     In cases of Plantar Fasciitis not responding to conservative management, minimally invasive     techniques may be used. These include platelet rich plasma injections and corticosteroid     injections. Corticosteroids have long been used for symptomatic relief. However there are     growth factors present in PRP injections that contribute to the healing of the pathology, and     not just symptom control.      A single blind, prospective, randomized, comparative, control study will be performed. The     study population consists of a total of 80 participants. They will be randomly assigned to     receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be     collected through questionnaires and ultrasound findings. Patients will have a follow up at     3, 6, 12, and 24 weeks after they receive their injection.   "
101521|NCT01957267|"     The specific aims of the clinical studies are to:        -  Improve Doppler OCT measurement of retinal blood flow.        -  Develop quantitative OCT angiography of the ONH        -  Measure nerve structure from ONH to retinal ganglion cells.        -  Establish or validate age-adjusted normal reference ranges for above OCT-derived          parameters.        -  Establish criteria for glaucoma diagnosis based on above imaging-derived parameters.        -  Evaluate the sensitivity and specificity of above OCT-derived parameters        -  Measure the rate of normal age-related change in above OCT-derived parameters.        -  Assess the reproducibility of above OCT-derived parameters.        -  Assess abilities of above OCT-derived parameters on predicting glaucoma conversion and          progression.   "
101764|NCT01954108|"     The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and     Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.   "
101494|NCT01957618|"     Hepatitis B virus (HBV) infection is a global health problem, especially in the endemic area     like Taiwan, where there are more than 3 million chronic hepatitis B carriers. Patients with     chronic HBV infection are at increased risk of developing cirrhosis, which may have     disastrous complications, including hepatic decompensation, and hepatocellular carcinoma     (HCC). The liver cirrhosis related complications accounts for the 8th leading cause of deaths     in Taiwan; whereas, the HCC is the 2nd leading cause of deaths among all cancers. Therefore,     it is prudent to develop strategies to prevent or halt the progression of liver cirrhosis.      For HBV patients who have already had cirrhosis, the main treatment objective is to reduce     their risk of complications. A large-scale multicenter clinical trial showed that viral     suppression using lamivudine in patients with advanced fibrosis effectively decreases the     risk of HCC and liver-related complications. This study highlights the importance to treat     HBV-related cirrhosis patients; however, several issues remain to be addressed.      The first issue is that this clinical trial only enrolled patients with positive HBeAg or     HBV-DNA level >1.4 x105 IU/mL. However, the current recommended threshold for cirrhotic     patients to start anti-viral treatment is 2000 IU/mL. Whether anti-HBV therapy benefits     cirrhotic patients in this level is still unclear. Second, lamivudine was used in this     clinical trial; however, the high resistant rate of lamivudine during treatment probably     lowers its protective effect against HCC. Whether a more potent anti-HBV agent with extremely     low resistance profile, entecavir, is more beneficial to HBV-related cirrhotic patients is     also unclear.      The Bureau of National Health Institute launched the reimbursement program for anti-HBV     therapy since 2003 and extended this program to cirrhotic patients with HBV DNA level > 2000     IU/mL for long-term use since Aug, 2010. Taking this advantage, we may explore the     above-mentioned clinical questions more easily.      To address these issues, we will first retrospectively collect a cohort of HBV-related     cirrhosis patients. All the patients will be enrolled from the time before oral anti-HBV     therapy is widely used. We will determine their baseline serum HBV-DNA levels using the     stored sera and enrolled those with baseline HBV-DNA levels higher than 2000 IU/mL as our     historical controls. Second, we will enroll a retrospective cohort of HBV-related cirrhotic     patients from 2008 who had HBV-DNA levels higher than 2000 IU/mL and received indefinite     therapy of entecavir. By comparing these two cohorts, we will be able to clarify whether     indefinite viral suppression by entecavir is beneficial for the cirrhotic patients.      With comprehensive analysis, we wish to document that re-setting the risk level of HBV DNA     from 140,000 IU/mL to 2,000 IU/mL is more beneficial for HBV-related cirrhotic patients and     long-term entecavir does lower the risk of HCC further. These lines of evidence will assist     in delivering appropriate and more aggressive treatment for these high-risk patients.   "
101495|NCT01957605|"     Venous return is driven by the pressure gradient between mean systemic pressure and right     atrial pressure. However, mean systemic pressure is more a physiological concept than an     available clinical measurement. Indeed, the mean systemic pressure is the one that would be     measured anywhere within the vascular system after cardiac arrest. Recent advances in     hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac     output measurements during respiratory pauses under mechanical ventilation. In this way, it     is possible to calculate MSP, the pressure gradient and the venous return resistances. The     investigators aim is to explain the hemodynamic variations and the decrease in cardiac output     observed during prone position. The investigators hypothesis is that venous return     resistances are increased during prone position probably following an increased     intra-abdominal pressure.   "
101496|NCT01957592|"     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the     current status of diabetes management, control, and complications in diabetic subjects in Sri     Lanka.   "
101497|NCT01957579|"     The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in     Japanese patients with relapsed or refractory advanced B-cell malignancies.   "
101498|NCT01957566|"     The purpose of the study is to validate the diagnostic performance of the amplified     pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in     propofol sedated nonintubated children. To determine the sensitivity/specificity and     positive/negative predictive value of the APS in detecting sedation-related adverse acute     respiratory events in propofol sedated nonintubated children.   "
101499|NCT01957553|"     The aim of the current investigation is to investigate the performance of a new 2-piece     ostomy product   "
101500|NCT01957540|"     Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall     mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in     the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown     that ticagrelor increases adenosine concentration, by interfering with its red blood cells'     uptake and by inducing the release of ATP which is then converted to adenosine. Recent     studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that     ticagrelor increases the coronary blood flow in response to intravenous adenosine     administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may     influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method     (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating     endothelial dysfunction and has been found to positively correlate with flow mediated     dilatation (FMD).      This is prospective, randomized study with a crossover design, which will be conducted in     patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a     3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:        -  Ticagrelor 90mg twice a day for the next 15 days or        -  Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients          wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement          will be repeated at Day 15 and then treatment crossover will be performed for the next          15 days (without an intervening washout period). At Day 30 patients will be subjected          again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken          from the patients in Day 0 for genotyping control.   "
101501|NCT01957527|"     Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall     mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in     the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown     that ticagrelor increases adenosine concentration, by interfering with its red blood cells'     uptake and by inducing the release of ATP which is then converted to adenosine. Recent     studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that     ticagrelor increases the coronary blood flow in response to intravenous adenosine     administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may     influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method     (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating     endothelial dysfunction and has been found to positively correlate with flow mediated     dilatation (FMD).      This is a prospective, observational study, which will be conducted in patients with coronary     artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor     maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year     antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at     Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post     study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0     for genotype analysis.   "
101502|NCT01957514|"     This pilot research trial studies collecting, analyzing, and storing samples from patients     with triple negative breast cancer (breast cancer cells that do not have estrogen receptors,     progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein)     that has spread to other places in the body receiving anti-cancer therapy. Studying samples     of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving     anti-cancer therapy may help doctors learn more about changes that occur in deoxyribonucleic     acid (DNA) and identify biomarkers related to cancer.   "
101512|NCT01957384|"     To assess the functionality and safety of the test products and also assess the products'     ability to collect stool without interfering with the stoma. The degree of leakage using the     product will also be measured   "
101513|NCT01957371|"     The primary objective of the current study is to establish the safety and acceptability of     Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and     chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish     preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore     anxiety sensitivity as a mechanism of therapeutic action.   "
101514|NCT01957358|"     The purpose of this study is to examine the usefulness of the Grief Recovery Method in     assisting persons with spinal cord injuries to achieve as complete a recovery as possible,     thereby allowing for fuller participation in life.   "
101515|NCT01957345|"     The primary purpose of the study is to evaluate a standardized method of screening for     platelet signalling defects in patients with constitutional disorders of platelet function of     unknown origin. We hypothesize that such defects are under-diagnosed in patients, due to     heavy workup and requirement of relatively large blood sample by conventional biochemical     methods. We propose to analyse kinase signalling downstream platelet membrane receptors using     multiplex flow cytometry quantification and fluorescent platelet barcoding.   "
101516|NCT01957332|"     Current patient work-up, including conventional imaging and pathological assessment of just     one single biopsy, might be insufficient to identify metastatic breast cancer patients, who     possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion     of the tumor is found quite frequently and molecular heterogeneity can occur within one     patient, up-to-date whole body information is necessary to determine estrogen receptor (ER)     and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide     therapy decision. With molecular imaging via PET this information can be obtained in a     non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and     be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating     tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular     characterization of one metastasis at the beginning and, if feasible, of an additional biopsy     during therapy, is necessary.   "
101517|NCT01957319|"     Background: Hepatitis C virus infection and interferon treatment have shown to be risk     factors for depression, distressing, psychosocial burden and poor health-related quality of     life.      Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and     whether health related factors (anxiety and depression) were associated with work ability in     subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.      Patients and Methods: In this prospective, randomized, placebo controlled, double blind     clinical trial, 31 subjects (Group A) with chronic hepatitis, received     Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects     (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus     association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12     months. All subjects underwent laboratory exams and questionnaires to evaluate depression     (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work     ability (Work ability Index - WAI).   "
101518|NCT01957306|"     The primary goal of this study is to evaluate the safety and efficacy of 12 weeks of     treatment of 4 grams/day of Dr. Tagliaferri's Menopause Formula (administered as 2 grams PO     BID) in reducing the frequency of menopausal vasomotor symptoms among healthy, postmenopausal     women, aged 40-65, with moderate to severe hot flushes.   "
101519|NCT01957293|"     Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and     cognitive functions in healthy humans.   "
101765|NCT01954095|"     The purpose of this study is to analyze how the body handles and responds to progesterone     treatment in parous and nulliparous women at risk of pre-term birth.   "
101522|NCT01957254|"     Endotoxin is the major mediator of gram-negative bacteria which cause the systemic     inflammation and result in microcirculatory dysfunction, and it leads to multiple organ     dysfunction and death in patients with severe sepsis and septic shock. The goal of this study     is to measure the endotoxin activity of patients with severe sepsis and septic shock at     certain time points, and furthermore, to compare the difference of endotoxin activity among     different pathogens, infection source, and antibiotics. The study will enroll severe sepsis     and septic shock patients. The endotoxin activity will be measured at certain time points     according to the protocol.   "
101523|NCT01957241|"     The primary goal of this study is to quantify the biomarkers of pre-radiation therapy(RT),     during-RT, and post-RT serum samples from hepatocellular carcinoma (HCC) and esophageal     cancer patients undergoing definitive or neoadjuvant RT, and to correlate them with tumor     response, patterns of failure, survival outcome, and RT-related lung or liver toxicity. The     secondary goal of this study is to set up the PLA platform in our institute for future     biomarker test.   "
101524|NCT01957228|"     On joint orthopaedic hardware infections are one of the most frequently encountered     complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological     diagnosis cannot be established despite obvious signs of infection. As part of this research     project, we have developed a new strategy diagnosis including directly the use of PCR to     reduce the number of negative results. This should have a major therapeutic impact in terms     of timeliness and specificity of antibiotic.      Primary:      Evaluate the effectiveness of the new diagnostic strategy on etiological identification of     prosthesis infections.      Hypothesis:      Minimum 6 percent increase in the number of patients with an etiological diagnosis of     infection on prosthesis.   "
101525|NCT01957215|"     This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle     sprain in adult patients, compared to a placebo patch   "
101526|NCT01957202|"     This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block     crossover study to evaluate the effect of single and repeat doses of levocabastine, FF,     placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study     duration for each individual participating in the study will be a maximum of up to 20 weeks     (including the screening and follow-up). This will be a three period study and subjects will     be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days     between two treatment periods. The rational for this study is to demonstrate proof of concept     with the FDC of FF and levocabastine compared with each of the components administered alone.   "
101527|NCT01957189|"     This will be an open-label, three-period, fixed-sequence study to evaluate the drug-drug     interaction, pharmacokinetics and safety of dutasteride and tamsulosin when administered     alone and in-combination in Chinese healthy male volunteers.   "
101528|NCT01957176|"     This study will provide continued access to treatment with eltrombopag for subjects who are     currently participating in a GlaxoSmithKline (GSK) sponsored investigational study of     eltrombopag (parent study) and to collect long term safety data.   "
101529|NCT01957163|"     After screening, subjects will enter a 4 week open-label run-in period with fluticasone     furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI).     Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide     [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once     daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing     treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a     total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1),     blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85     (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last     clinic visit. The total duration of subject participation in the study from Screening to     Follow-up will be approximately 17 weeks.   "
101530|NCT01957150|"     This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation     powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD     over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled     corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI     treatment with VI treatment in subjects with moderate COPD.   "
101531|NCT01957137|"     The study will assess the effects of different InterStim cycling settings on urinary urge     incontinence.   "
101532|NCT01957124|"     Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is     not well established.      We want to study the efficacy of PRF applications on the pains related to those ulcers.      PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from     patient's blood, without any additive nor complex manipulation. It contains blood platelets     and white blood cells, trapped in fibrin during clot formation.      PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does     not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are     placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to     difference of density, and blood platelets and white blood cells are trapped in the fibrin     clot.      The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis     is that platelet growth factors and cytokines, liberated during platelet activation, could     help to treat hypertensive leg ulcers, that are caused by a vascular spasm.   "
101533|NCT01957111|"     Individuals with insomnia have been shown to have higher overall metabolic rates compared to     good sleepers, but it is not known which metabolic processes are involved. The goal of this     study is to compare a wide array of metabolic processes in 15 people with insomnia and 15     good sleepers. We hypothesize that there will be distinct metabolic processes that are     functioning differently in those with insomnia.   "
101534|NCT01957098|"     The purpose of this study is to investigate the effect of L-arabinose and D-xylose in a     sugar-rich drink on intestinal sucrase activity in healthy volunteers by measuring     postprandial blood glucose and insulin, and selected intestinal hormonal responses to     increasing doses of L-arabinose and D-xylose.   "
102153|NCT01949207|"     The aim of this randomised case-controlled trial is to investigate whether ablation of     incompetent perforating vein in addition to ablation of truncal vein reduces the rate of     recurrent varicose veins post-treatment compared with patients who only have ablation of the     truncal vein, who are left with untreated incompetent perforating veins.   "
101535|NCT01957085|"     The Centers for Disease Control and Prevention estimates that there are approximately 3.2     million people in the United States infected with hepatitis C and a significant percentage of     these patients are unaware of their diagnosis. This study will attempt to determine the point     prevalence of undiagnosed hepatitis C infection in an urban hospital population. All patients     admitted to the hospital on two separate days will have hepatitis C testing done on leftover     serum and plasma that was collected as part of routine inpatient lab work. Our primary goal     is to determine the number of undiagnosed hepatitis C infected patients in our hospitalized     population. We will also compare these rates to specific demographic characteristics, such as     age, race, gender, zip code and type of insurance to see if any associations exist between     these demographics and undiagnosed hepatitis C infection.   "
101536|NCT01957072|"     Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to     become clogged with thick, sticky mucus. This leads to recurrent lung infections and reduced     nutrients absorption from food. The average age at death is 26 years, usually from     respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is     important help them live healthier and longer.      It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females.     However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional     support to help support weight gain. There is a clear need for a behavioural intervention     that can help PWCF use the available nutritional support.      This is a feasibility study to try out a multi-component behavioural intervention. The     intervention is designed to help PWCF use their nutritional support to gain weight. It will     focus on testing the methods and procedures to be used on a larger scale, improving the     behavioural intervention and estimating the how many people are needed for the larger trial.      All eligible 75 PWCF in Sheffield will be invited to participate. The investigators     anticipate recruiting 30 participants. Participants will be divided into two groups. The     first group receive the behavioural intervention immediately. The second group receive the     intervention after 3 months. All participants will be followed up for 6 months. Data will be     collected every 6 weeks during clinic reviews.      These two groups will be compared against each other to estimate the potential impact of the     behavioural intervention. The investigators will also interview some of the participants at     the end of the study period to improve the intervention and the study processes based on     participant feedback.      The investigators hypothesised that this study will recruit around 30 participants, around     80% of the participants will complete the study, a single full-time investigator can deliver     the intervention to 15 participants over 3 months and data collection will be thorough (with     less than 5% missing data). The investigators also hypothesised that this feasibility study     will help improve the intervention and help the design of a larger trial.   "
101537|NCT01957059|"     The purpose of the study is to see whether BMN053 is safe and effective to use as medication     for Duchenne muscular dystrophy (DMD) patients with a mutation around location 53 in the DNA     for the dystrophin protein.   "
101557|NCT01956799|"     The study aims to evaluate the molecular mechanism underlying the erythroid response observed     in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated with     Deferasirox or Deferoxamina.   "
101558|NCT01956786|"     To evaluate the efficacy of Amlodipine-Folic Acid Tablets on reduction of blood pressure and     plasma total homocysteine.   "
101538|NCT01957046|"     The main purpose of this study is to assess how effective and tolerable the country specific     clinical practice guidelines of SLTs are for UK, France and Sweden are.      The main rationale behind this study is that well controlled comparisons of the various     laxatives for the treatment of OIC are lacking. There is lack of evidence suggesting which     laxative or combination of laxatives is optimal for managing OIC.   "
101539|NCT01957033|"     The purpose of this pilot project is to determine the feasibility of a study design to     investigate how many sessions of manual therapy and exercise produce the best results for     people with whiplash injuries. Also, this study will help us determine the best way to     measure the effect of treatment. Finally, the investigators will study how closely the     physiotherapists follow the treatment instruction provided in the study protocol and     training. In order to achieve these objectives, 12 people will receive manual therapy and     exercise at one of twelve different doses. the investigators will have each of these people     fill out questionnaires, measure sensation changes, and measure changes in the way people     move their necks while walking. This study will help us determine if the study protocol can     be carried out as planned. This includes: the training of all people involved in carrying out     the assessments and treatments, the willingness and ability of participants to take part in     all of the treatment and measures involved. This will provide us with important information     to help us plan a larger study with 226 people with whiplash injuries.   "
101540|NCT01957020|"     Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy     procedure for suspicious findings on mammograms in Western countries for more than 10 years     [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike     and was reported to feature a high sensitivity, very low delayed false-negative rate (less     than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients and     less morbidity compared with needle localization excisional biopsy [6,7]. However, its     sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian     women have different breast parenchyma pattern, different breast cancer prevalence.     Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving     either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an     effective alternative to NLOC excisional biopsy in our country.   "
101541|NCT01957007|"     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and     PK of vantictumab when combined with docetaxel.   "
101542|NCT01956994|"     The hardening of the arteries observed with aging raises blood pressure and contributes to     poor brain blood flow and loss of cognitive function (i.e. attention, memory, solving     problems, making decisions). Cognition is the most important determinant of overall health     status, quality of life, functional ability and independence in older adulthood.     Nutraceutical strategies have received considerable attention as they may improve     cardiovascular health with far fewer side effects compared to drugs. In this regard, dairy     products are particularly attractive. Higher dairy consumption is associated with lower blood     pressure and improved memory in adults. Milk proteins have natural blood pressure lowering     effects. Studies conducted in animals have demonstrated that whey protein (a component of     milk protein) may also increase artery elasticity. This is important given the strong     association between artery elasticity, brain blood flow, and risk for cognitive decline.      The investigators propose to conduct a randomized double-blind placebo controlled study     comparing the effects of whey protein supplementation or carbohydrate placebo on measures of     artery elasticity, brain blood flow, and cognitive function in older adults. Whey protein may     be a novel dietary therapy to improve both artery health and brain health in older adults.   "
101543|NCT01956981|"     It is very important to decrease the bleeding during functional endoscopic sinus surgery     (FESS) in order to increase the visibility of the surgical site. Our primary goal was to     investigate the effects of magnesium sulfate and dexmedetomidine used for controlled     hypotension on visibility of surgical site.   "
102270|NCT01947478|"     The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the     interventional treatment of de novo and non-stented restenotic lesions in the superficial     femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with     standard percutaneous transluminal angioplasty (PTA).   "
101544|NCT01956968|"     Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These     abnormal movements may result from a variety of flexibilty, motion or strength impairments.     Therefore identifying any abnormal arm or scapular movement, as well as any impairments that     are associated with them can help clinicians plan a proper management strategy for patients     presenting with shoulder disorders. Our hypothesis is that specific impairments will be     associated with abnormal arm movement, while other impairments will be associated with     abnormal scapular movement among patients with shoulder pain.   "
101545|NCT01956955|"     Purpose and rationale: Acute pulmonary embolism (PE) is a common and often fatal disease,     with an approximately 30% mortality rate without treatment. Treatment is important to reduce     mortality and recurrence in acute PE. Therapeutic options for PE include subcutaneous low     molecular weight heparin (SC LMWH), intravenous unfractionated heparin (IV UFH), subcutaneous     unfractionated heparin and subcutaneous fondaparinux with or without thrombolysis. In the     treatment of acute PE, SC LMWH has been shown, at least, as effective and safe as IV UFH [4].     Compared to IV UFH, SC LMWH associated with lower mortality, fewer recurrent thrombotic     events and less major bleeding. Current guidelines recommend use of SC LMWH for most     hemodynamically stable patients with PE and they say that SC LMWH have not been tested in the     setting of acute massive PE.      The purpose of this study is to demonstrate that SC LMWH is as safe as IV UFH in the     treatment of acute PE in combination with thrombolytic treatment.   "
101546|NCT01956942|"     The purpose of this study is to evaluate the effectiveness of a new laser (called Micropulse     Laser Trabeculoplasty or MLT) in the treatment of glaucoma compared to the conventional laser     presently used which is called selective laser trabeculoplasty or SLT. Both lasers (SLT and     MLT) are used as standard of care in the treatment of open angle glaucoma.   "
101582|NCT01956474|"     The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced     cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and     biochemical stability of the cornea by inducing additional cross-links within or between     collagen fibers using UVA light and the photo- mediator riboflavin.   "
101548|NCT01956916|"     Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and     gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI     tracts is influenced by both genetic and environmental factors. Children with CF may harbor     an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane     conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes     and acid suppressors). The investigators have previously demonstrated that intestinal     inflammation is highly frequent in CF children, being a major feature of intestinal     involvement. In addition, specific probiotics significantly improved airway and GI     inflammation in a preliminary trial. The investigators aim to characterize intestinal and     respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus     GG (LGG) supplementation on both GI and airway microflora and the eventual relationship     between probiotic assumption and clinical and inflammation markers. The investigators aim is     to eventually improve the quality of life of CF patients, who often suffer from intestinal     and respiratory progressive disease, through a non invasive intervention consisting in the     supplementation of probiotic bacteria.   "
101549|NCT01956903|"     The purpose of this study is to determine the safety and efficacy of sequential infusion of     allogenic mesenchymal stem cells (MSC) expanded in vitro in treating patients with acute     graft-versus-host disease refractory to first-line therapy.   "
101550|NCT01956890|"     This prospective study is aimed to evaluate the diagnostic effectiveness of 18F-FLT PET in     differentiating benign nature from malignancy for lesions with suspicious or ambiguous     findings on mammography or ultrasound; to determine whether 18F-FLT PET or MRI can increase     the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy, and which     (18F-FLT PET or MRI) reveals the higher diagnostic performance.   "
101551|NCT01956877|"     To assess normal values of EGJ distensibility in healthy volunteers.   "
101552|NCT01956864|"     The purpose of this study is to evaluate the safety and tolerability of a high dose of     vitamin D (VD) in patients with cirrhosis. The investigator hypothesizes that high dose VD     will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory     and proliferative events that cause progression of cirrhosis to hepatocellular carcinoma.   "
101553|NCT01956851|"     Since the discovery of kisspeptin as a gate-keeper of hypothalamo-pituitary-gonadal axis,     there has been tremendous interest in the molecule. The relevance of kisspeptin as regulatory     molecule for the reproductive system has been well documented in significant number of     trials. (1, 2) This leads to the possibility that kisspeptin could be involved in an equally     pivotal role in the other sites, where it is located, namely pancreas.      While various animal experiments have suggested that kisspeptins regulate insulin secretion,     we do not know if this is also true in humans. The investigators hypothesize that kisspeptin     levels are significantly low in individuals who have low endogenous insulin secretion.      While various animal experiments have suggested that kisspeptins regulate insulin secretion,     the investigators do not know if this is also true in humans. Investigators hypothesize that     kisspeptin levels are significantly low in individuals who have low endogenous insulin     secretion.      Thus investigators are conducting this study to understand the link between endogenous     insulin secretion and kisspeptin levels among individuals with various levels of insulin     secretory defect as seen in diabetics. Investigators believe that this will help understand     the physiologic mechanisms, and kisspeptin based insulin regulation among individuals with     diabetes mellitus.   "
101563|NCT01956721|"     The aim of this project is to investigate the impact of heart failure (HF) on calcium     homeostasis, mitochondrial function and oxydative stress in human skeletal muscle. The role     playing by circulating factors such as cytokines and catecholamines will also be evaluated.     24 HF patients wiil be enrolled in the study: 12 male volunteers with a fraction of ejection     ≥ 50% and 12 male volunteers with a fraction of ejection ≤ 35%. They will be compared to 12     sedentary healthy male volunteers, matched on age and physical activity.   "
101564|NCT01956708|"     Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion     provides peri-operative myocardial protection, is safe and improves prognosis in patients     undergoing elective CABG surgery.      The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify     the pathways which transfer the cardioprotective signal from the ischemic/reperfused     extremity to the heart in humans undergoing surgical coronary revascularization.   "
101554|NCT01956838|"     Rationale: The appearance of tastants in the small intestine can result in the activation of     a negative feedback mechanism from different parts of the intestine to the stomach, the small     intestine and to the central nervous system. These processes inhibit food processing,     appetite sensations and food intake, and furthermore they increase feelings of satiety and     satiation. We will investigate the effects of intraduodenal infusion of quinine 75mg     (bitter), rebaudioside A 540mg (sweet), monosodium glutamate 2g (umami), a combination of     these tastants (quinine, rebaudioside A, monosodium glutamate) and placebo (5 test days in     total) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides     CCK and GLP-1.      Study design: To assess the effect of intraduodenal infusion of single ingredients and a     combination of tastants (bitter, umami and sweet) on ad libitum food intake.      Secondary Objective(s):        1. To investigate the effect of intraduodenal delivery of a combination of tastants on          satiation.        2. To assess the effect of intraduodenal delivery of a combination of tastants on          gastrointestinal hormone release.        3. To assess the effects of the tastants quinine, rebaudioside A and monosodium glutamate          on the parameters as mentioned under the primary objective, and under secondary          objectives 1 and 2.        4. To compare the effects, as mentioned under the primary objective, and under secondary          objectives 1 and 2, of the combination of tastants to those of the three single tastants          quinine, rebaudioside A and monosodium glutamate.   "
101555|NCT01956825|"     The purpose of this study is to determine whether the dual therapy of the amino acid     L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with     non alcoholic fatty liver disease (NAFLD).   "
101556|NCT01956812|"     The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose     gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients     who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a     gemcitabine-containing regimen).   "
101559|NCT01956773|"     The outcome of this research will be a demonstration that family health history (FHH) risk     data can be used efficiently to deliver more effective healthcare in geographically and     ethnically diverse clinical care environments. Although FHH is a standard component of the     medical interview its widespread adoption is hindered by three major barriers: (1) a dearth     of standard collection methods; (2) the absence of health care provider access to complete     FHH information; and (3) the need for clinical guidance for the interpretation and use of     FHH. In addition, the time constraints of the busy provider and poor integration of FHH with     paper medical records or electronic medical records (EMR) impede its widespread use. The     investigators hypothesize that patient-driven and electronic collection of FHH for risk     stratification will promote more informed decision-making by patients and providers, and     improves adherence to risk-stratified preventive care guidelines. The study team will use an     implementation sciences approach to integrate an innovative FHH system that collects FHH from     patients. Intermountain Healthcare will provide the information technology expertise with EMR     design to develop an innovative solution to a storage model standard for FHH data as well as     a centralized standards-compliant open clinical decision support (OpenCDS) rule development     architecture to analyze FHH and to generate evidence-based, individualized, disease risk,     preventive care recommendations for both patients and providers.   "
101560|NCT01956760|"     The aim of this clinical study is to observe the therapeutic effect of acupuncture and     intradermal acupuncture in the treatment of insomnia      Participants were randomized into the acupuncture group and control group. Both groups were     treated 3 times in a week and assessed before and after the treatment.      Hypothesis :        1. Acupuncture group will produce superior effect in the treatment of insomnia compared          with control group.        2. Acupuncture group will produce superior improvement in anxiety, depression, quality of          life, sleep log, recognition, attention, and memory.   "
101561|NCT01956747|"     The purpose of this study is to assess whether the presence of a Myelodysplastic Syndrome     (MDS) , Idiopathic Cytopenia of Undetermined Significance (ICUS) or Idiopathic Dysplasia of     Undetermined Significance (IDUS), correlates with treatment intensity and clinical outcome in     older patients with advanced malignancies receiving palliative chemotherapy. We will study     the relation between sarcopenia, comprehensive geriatric assessment en pharmacokinetics with     treatment related toxicity as well. We hypothesize that a standardized flow cytometry test to     determine bone marrow capacity, a Comprehensive Geriatric Assessment and/or measurement of     human body composition with computerized tomography will provide an accurate tool to optimize     treatment strategies in elderly patients with advanced malignancies.   "
101562|NCT01956734|"     Phase I trial, unicentric, uncontrolled. Intratumoral injection or intramural (into the     resected tumor cavity) of DNX2401 into brain tissue will be followed by up to two 28 - day     cycles of oral temozolomide (TMZ) in schedule of 7 days on/7 days off to evaluate safety of     the combination. Completion of two full cycles of TMZ will be dependent upon tolerance and     toxicity.      The rationale in using the virus with chemotherapy begins with the lessons learned in many     clinical trials in glioblastoma (GBM) about both the great difficulty of treating this     disease with monotherapy and the limitations of the therapeutic virus. The best clinical     results in recent years have been achieved with combinations of multiple therapeutics     efforts, including, maximum resection and chemotherapy, immunotherapy and targeted therapies.      There are very strong preclinical data about the synergy of DNX-2401 and TMZ proposed in our     trial design. The dose-dense schemes of TMZ like the one we will use, have been developed     with the aim to saturate o6-methylguanine-DNA-methyltransferase (MGMT). The published results     to date have shown reasonable toxicity albeit with modest efficacy' these schemes are now in     phase III trials. In addition, autophagy triggered by TMZ could help viral replication in the     tumor cells 11.      The last argument in favor of this virus + TMZ combination is the proved efficacy in killing     GBM tumor stem cells. In vitro and animals models have shown this combination is much more     effective that any of the treatments alone against GBM stem cells and the tumors derived from     them.   "
101565|NCT01956695|"     Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell     lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy     of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be     observed in PCNSL.      This study will assess the efficiency of the the combination of lenalidomide and rituximab in     relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide     alone in maintaining the response.   "
101566|NCT01956682|"     The primary objective of this trial is to show that an hypoallergenic infant starter formula     containing starch and the probiotic L. reuteri decreases the severity of     regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have     taken it for 4 weeks, in comparison with a standard infant starter formula.   "
101567|NCT01956669|"     The purpose of this study is to find out what effects, good or bad, pazopanib (GW786034),     National Service Center (NSC) # 737754, has on children, adolescents and young adults between     12 months and less than or equal to 18 years of age with relapsed or refractory     rhabdomyosarcoma, non rhabdomyosarcomatous soft tissue sarcoma, Ewing sarcoma, relapsed or     refractory osteosarcoma, neuroblastoma (measurable and/or evaluable), or hepatoblastoma. This     is a two-stage open label phase II trial of pazopanib in children, adolescents and young     adults with recurrent or refractory solid tumors. Eligible subjects will receive pazopanib     daily as an oral tablet (450 mg/m^2/dose) or as a powder for suspension (225 mg/m^2/dose) in     28 day cycles. The maximum dose to be administered daily for tablets is 800 mg and for     suspension 400 mg. Subjects will be closely monitored with clinical and laboratory     observations for side effects. Response to treatment will be evaluated using appropriate     imaging studies. In the absence of severe toxicity or progressive disease, subjects may     continue receiving pazopanib.   "
101568|NCT01956656|"     Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective     chemical adjunctive measures will likely significantly contribute to overall oral health, the     function of which should be to augment mechanical plaque control. Traditionally, in Chinese     medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus     leaves have demonstrated significant antibacterial activity against some of the     periodontopathogens.   "
101804|NCT01953575|"     Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal     impedance?      And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities     in mucosal impedance?   "
101569|NCT01956643|"     Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as     surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return     of normal gut function Chewing gum has recently been used as a form of sham feeding to     stimulate acceleration of gut function after abdominal surgery.      The investigators hypothesize that sham feeding with chewing gum will accelerate return of     gut function after liver transplantation.   "
101570|NCT01956630|"     Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment     for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient     survival, is so far treated by second transplantation and donor leukocyte infusion (DLI),     which seems to have high risk and low survival. Need for a new medication on relapse is     urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer     (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual     disease. This randomized study was conducted to evaluate the feasibility and effective of     genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.   "
101571|NCT01956617|"     The Shamrock method is a new ultrasound-guided lumbar plexus block. The aim of the study is     to determine the minimum effective volume of ropivacaine 0.5% required to produce an     effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method     study design, 30 patients scheduled for elective total hip and knee arthroplasty will be     included in the study.   "
101572|NCT01956604|"     Delirium (acute confusional state)is characterized by an acute decline in attention and     cognition, and is a common clinical syndrome in elderly patients.      The purpose of this randomised, controlled, parallel group pilot trial is to explore     superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at     the acute geriatric ward.      We will also study the feasibility of oral clonidine in a geriatric ward and effects of     clonidine upon a variety of outcomes as a means to design a more definite study later.   "
101573|NCT01956591|"     Evaluate the long term efficacy and side effects of oxybutynin in the treatment of     hyperhidrosis.   "
101574|NCT01956578|"     This study will evaluate the correlation between the respiratory rate derived from the Reveal     Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained     from an external respiratory band in patients previously implanted with a Reveal for     unexplained syncope or suspected arrhythmia.   "
101575|NCT01956565|"     The feasibility study will involve mixed methods, this means interviews as well as assessment     of treatment with inspiratory muscle training therapy (IMT). There are two pathways within     the study depending on whether people want to have inspiratory muscle training. People who     accept to have inspiratory muscle training will have assessments before training, after 8     weeks of training and at 6 month follow up in addition to interviews before and after the     study (at 6 months). For those who choose not to have the inspiratory muscle training the     investigators will offer them an interview so that the investigators can find out more about     what might have made the study more appealing or what treatments they would have preferred.     The investigators will also ask if they wish to be followed up with baseline assessments for     the study period and if the investigators can access health records.      Interviews      Semi-structured interviews lasting approximately an hour will be performed at the beginning     of the study with participants who accept the IMT pathway and those who decline IMT until no     knew themes are raised. These interviews will be used to provide information on reasons for     declining pulmonary rehabilitation, attitudes to exercise, attitudes to IMT, treatment     preferences and opinions regarding study design and outcome measures (see Interview Topic     guide). The interviews will be taped and transcribed verbatim. A follow up interview with     study participants who have received IMT will be conducted at 6 months addressing attitudes     to IMT and study design and whether they have decided that they wish to engage with other     services (such as pulmonary rehabilitation and smoking cessation).      Inspiratory Muscle Training (IMT) method      Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic     device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax).     This means that each breath in through the device is set at 60% of the maximum force you are     able to create when you breathe in rather than at full force. 30 breaths are performed at     high velocity (paced initially over a period of 15 minutes to allow recovery between each     breath through the device). Once established it is anticipated that each training session     should take no more than five minutes. Training is performed twice a day, 5 days per week for     the first 8 weeks. Training will be titrated (set to a level suitable for the participant)     and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the     participants are advised to continue training unsupervised, twice a day, 3 times per week for     a further 18 weeks.   "
101576|NCT01956552|"     The primary objective is to compare the phenotype and genotype of the primary tumor with     those of its metastases in order to optimize the treatment of metastatic disease, in patients     presenting with first metastatic progression of breast cancer.   "
101623|NCT01955941|"     The purpose of this study is to learn how blood flows to tumors in patients treated with     I-125 plaque brachytherapy for uveal melanoma.   "
101577|NCT01956539|"     Heart failure is the most common heart disease with increasing incidence due to the aging of     the population is improving the initial prognosis of various conditions that lead to more or     less progressive heart failure.      Heart failure is of great variety of clinical and pathophysiological forms necessitating the     creation of quality records to clarify each of these forms.      Many types of cardiomyopathies exist, some of which are infrequent but with specific care.      At the French level, few data exist. In addition, the therapeutic management changes     regularly.      New European recommendations (endorsed by the French Society of Cardiology = FSC) were     published in May 2012. Many therapeutic approaches are being evaluated. The course of care     and how to take non-drug load (network monitoring, rehabilitation ...) have become important     issues that have hardly been analyzed by existing records.      This also leads to better define the different forms of this disease, their natural history     and methods of management applied in real life. The register of FSC follows the registry of     the European Society of Cardiology (ESC)Heart Failure (HF) Long Term (CCTIRS No. 11.355bis)     with inclusions will be completed in November 2012. This new study aims to generate more     accurate data on a number of points and be more representative for a wider selection of     patients, the French level.   "
101578|NCT01956526|"     The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two     treatment groups, CORolla™ Stand-alone group and  AVR & CORolla™ Add on group.   "
101579|NCT01956513|"     The main objective of the study is to assess the sensitivity and the specificity of the     variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant     chemotherapy or after modification of the treatment sequence, the pathological response at     the end of chemotherapy   "
101580|NCT01956500|"     The primary purpose of this study is to assess the effect of 8-weeks ingestion of the     Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on     joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood     inflammation biomarkers in adults with self-reported joint pain.   "
101581|NCT01956487|"     Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites   "
102266|NCT01947530|"     The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked     devices compared to standard bronchoscopy.   "
101583|NCT01956461|"     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone     turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients     under clinical practice. The participants are treated in the investigators hospital, who are     under severe osteoporotic condition.      Several determinants were reported to be related to subsequent BMD increase, such as baseline     bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive     discussion is lacking. Specifically, there analyses were performed fragmentarily.      The main objective of this study is to reveal the determinants of subsequent BMD increase and     fracture preventing effect by teriparatide.      Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As     a result, there is a lot of nursing home. But there are few reports concerning to the     efficacy of teriparatide treatment in nursing home patients. The second objective is to     reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes,     bone turnover makers change, and adverse events.   "
101584|NCT01956448|"     To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity®     stents in the treatment of unselected patients with ischemic heart disease.   "
101585|NCT01956435|"     This pilot study will consist of 10 adult subjects with symmetric idiopathic guttate     hypomelanosis on the lower legs. Subjects will be randomized to which extremity (right or     left) will be treated. Treatments with the Xtrac Excimer laser will be performed twice weekly     for 12 weeks using the typical vitiligo protocol. Our goal is to determine the effectiveness     of excimer laser for repigmentation of idiopathic guttate hypomelanosis. Effectiveness will     be graded by the blinded observer scale via photographic comparisons and will be graded by     subject via survey every 4 weeks.   "
101586|NCT01956422|"     Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce     the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2<60     mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal     value.   "
101587|NCT01956409|"     The application of FCH PET in breast cancer diagnosis has not been reported.      We hypothesize that FCH reveals choline metabolic profiles of breast cancers, and shows the     similar pathophysiological mechanism to choline on proton MRS, and our study goals are:        1. To investigate and compare the diagnostic performance of proton MRS and FCH PET for          localized findings on mammography and breast ultrasound.        2. To investigate whether FCH PET findings are correlated with choline signals on proton          MRS.        3. To evaluate if choline, water and lipid signals on proton MRS, FCH PET are associated          with factors related to clinical outcome and prognosis- that is, molecular markers,          tumor staging, histologic grade of breast cancers.        4. For localized advanced breast cancer, to investigate the treatment response to NAC using          proton MRS and FCH PET, and to evaluate which modality is more sensitive.        5. To investigate the usefulness of FCH PET for whole body staging for breast cancer          patients.   "
101588|NCT01956396|"     The protocol, approved by the Medical Research Council, was issued to assess the safety and     efficacy of the non-surgical device for applying it to the national scale up of adult male     circumcision in Zimbabwe   "
101589|NCT01956383|"     The protocol, approved by the Medical Research Council, was issued to assess the safety and     efficacy of the non-surgical device for applying it to the national scale up of adult male     circumcision in Zimbabwe   "
101590|NCT01956370|"     The protocol, approved by the Medical Research Council, was issued to assess the safety and     efficacy of the non-surgical device for applying it to the national scale up of adult male     circumcision in Zimbabwe   "
101591|NCT01956357|"     The aim of this study was to analyse the acute and chronic effects of two aerobic-training     models performed in water and on dry land on cardiorespiratory, functional, metabolic,     hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).   "
101592|NCT01956344|"     The purpose of this research is to measure changes in brain activity with functional magnetic     resonance imaging (fMRI) before and after cognitive-behavioral therapy for compulsive     hoarding. Cognitive-behavioral therapy aims to help people change the thoughts and behaviors     that maintain symptoms of hoarding. The investigators intend to enroll approximately 80     people with hoarding disorder and 40 people with no psychiatric disorder, between the ages of     20 and 60, for this study. The investigators believe that after treatment there will be     changes in the brain activity of individuals with compulsive hoarding.   "
101593|NCT01956331|"     schema : Prospective prognostic study The main objective is to study the value of the     Comprehensive Geriatric Assessment in predicting the risk of post operative complications     after lung resection for cancer.   "
101594|NCT01956318|"     At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic     venous insufficiency.   "
101595|NCT01956305|"     DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be     a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to     assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple     doses of DS-7309 in subjects with T2DM.   "
101596|NCT01956292|"     Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral     haemorrhage and its consequences to clinical outcome   "
101597|NCT01956279|"     This study will investigate the use of adjunctive pregnenolone for the following:        1. fatigue that has limited usual activity,        2. musculoskeletal pain involving 2 or more regions of the body and,        3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report)          in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.   "
101625|NCT01955915|"     The purpose of this study is to see if mapping blood vessel patterns with optical coherence     tomography (OCT) will help identify life-threatening choroidal tumors in their early stages     and improve overall patient survival through early detection.   "
101633|NCT01955811|"     Patients with need of platelet transfusion for any reason will participate in this study.     Directly before the start of infusion and one hour after the end of platelet transfusion     blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood     clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion     will be compared. The study hypothesis is that treatment with Fibrinogen results in a better     stabilisation of blood coagulation.   "
101598|NCT01956266|"     This study investigates a treatment protocol which holds the potential to significantly     improve communication and quality of life for individuals affected by Parkinson's disease     (PD). Disorders of emotional communication are widely reported in PD and can negatively     impact quality of life by increasing social isolation and decreasing independence.     Individuals with emotional prosodic communication disorders are often perceived as depressed     or unconcerned about others. This seeming negativity can cause difficulties in relationships,     and increased feelings of stress and burden in caregivers which may result in earlier     placement in an institutional care setting. This innovative treatment program could improve     care for individuals with PD, as well as other individuals who may be affected by disorders     of emotional prosodic communication (e.g., stroke or traumatic brain injury).   "
101599|NCT01956253|"     This study will be a single subject study to evaluate the efficacy of the HER2 kinase     inhibitor, neratinib, in a patient with metastatic bladder cancer harboring a HER2-GRB7 gene     fusion.   "
101600|NCT01956240|"     The purpose of this study is to verify the effects of a stretching protocol for the     pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during     arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened     pectoralis minor.   "
101601|NCT01956227|"     Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of     persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in     medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The     effects of a fall are often compounded as it can lead to activity curtailment, physiological     deconditioning, and institutionalization. Despite the importance of falls in persons with MS,     the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The     purpose of this investigation is to determine whether exercise based or educational based     interventions are more suited for fall prevention in older adults with MS.   "
101602|NCT01956214|"     Both strength training and endurance exercise training are commonly prescribed to improve     strength and function in patients with physical limitations caused by chronic disease or     disability including chronic kidney disease (CKD). Individuals with CKD often have low     physical function due to progressive declines in the performance of their kidneys. The low     physical function leads to physical inactivity, which exacerbates these functional declines     and promotes cardiovascular disease and bone disorders. In addition, severe functional     limitations in some patients prevent them from exercising at a great enough intensity to     provide significant benefits. As a result, alternative strategies are needed to maximize the     benefits of exercise while decreasing injury risk.   "
101603|NCT01956201|"     The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and     Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.   "
101604|NCT01956188|"     It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory     properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid     arthritis, although not with controversy. Systemic lupus erythematosus is an autoimmune     disease characterized by a chronic inflammatory state which is associated with the disease´s     clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially     affect the inflammatory cytokine profile and clinical features of LES patients.   "
101605|NCT01956175|"     The purpose of this study is to evaluate whether electrical pharyngeal stimulation in     addition to standard care can enhance short-term swallow recovery in tracheostomized     dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham     treatment plus standard care.   "
101606|NCT01956162|"     Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication     committee (PROBE methodology), comparing Orthèse Diabète with conventional removable     devices in terms of healing of ulcers.      - Primary objective: Evaluate the efficiency of Orthèse Diabète compared to conventional     removable devices, in terms of the proportion of diabetic patients whose principal ulcer will     heal completely at 3 months.   "
101607|NCT01956149|"     Single-arm study to determine disease control rate in second- (or later) line treatment with     cabazitaxel after the failure of palliative primary treatment.   "
101656|NCT01955512|"     In asthma, breathing in an allergen, such as house dust mite induces inflammation in the     airways. This process appears to involve an interaction between two different sorts of blood     cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose     of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor on     platelets, reduces inflammation following breathing in house dust mite in people with mild     asthma.   "
101608|NCT01956136|"     Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability     among adolescents and young adults. Especially the cognitive, emotional, and motors deficits     caused by TBI often impair everyday psychosocial functioning, quality of life and ability to     work. The purpose of the study is to determine the long-term effect of music-based     rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents     and young adults, and to study the neural mechanisms that underlie behavioural recovery and     the efficacy of music.   "
101609|NCT01956123|"     This trial investigates the immunogenicity of FE 999049 in repeated cycles.   "
101610|NCT01956110|"     This trial investigates the effects of FE 999049 compared to Gonal-F.   "
101611|NCT01956097|"     The objectives of the current study are to evaluate the efficacy and safety of HX106 in     healthy adults with subjective memory complaints for improving neurocognitive functions and     to find the changes of brain using magnetic resonance imaging and their associations with the     neurocognitive function enhancement.   "
101626|NCT01955902|"     The purpose of the proposed study is perform focus groups to identify and prioritize features     of the SubAID application (APP). The SubAID APP is smartphone APP being created to support     patients self-managing buprenorphine/naloxone (bup/nal) medication. Many people have     difficulty in managing bup/nal in the prescribed manner. Not taking medicines in their     prescribed manner can cause negative health outcomes.      Focus group participants will be asked to elaborate on medication-taking patterns that work     best for them, pitfalls associated with poor adherence and offer opinions upon what     features/functions the SubAID APP should perform to be most helpful to them. The focus group     is designed to remain open-ended and allow free discussion regarding each particular topic     that the moderator will bring up.   "
101612|NCT01956084|"     In this study, investigators are trying to see if LMP specific cytotoxic T lymphocytes (CTLs)     will prevent or treat disease called Epstein Barr Virus (EBV) Disorder including either     Hodgkin Lymphoma or non-Hodgkin Lymphoma or Lymphoepithelioma or severe chronic active EBV     infection syndrome (SCAEBV) or Leiomyosarcoma which has come back or has not gone away after     treatment, including the best treatment. Investigators are using special immune system cells     called third party LMP specific cytotoxic T lymphocytes (CTLs), a new experimental therapy.      Some patients with Lymphoma or SCAEBV or Leiomyosarcoma show evidence of infection with the     virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of     their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's     and non-Hodgkin Lymphoma, suggesting that it may play a role in causing Lymphoma. The cancer     cells (in lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the     body's immune system and escape destruction. The investigators want to see if special white     blood cells, called T cells, that have been trained to kill EBV infected cells can survive in     patient's blood and affect the tumor or infection.      Investigators used this sort of therapy to treat a different type of cancer that occurs after     bone marrow or solid organ transplant called post transplant lymphoma. In this type of cancer     the tumor cells have 9 proteins made by EBV on their surface. They grew T cells in the     laboratory that recognized all 9 proteins and were able to successfully prevent and treat     post transplant lymphoma. However in Hodgkin Lymphoma, the tumor cells and B cells only     express 2 EBV proteins. In a previous study they made T cells that recognized all 9 proteins     and gave them to patients with Hodgkin Lymphoma. Some patients had a partial response to this     therapy but no patients had a complete response. They think one reason may be that many of     the T cells reacted with proteins that were not on the tumor cells. In this present study the     investigators are trying to find out if the investigators can improve this treatment by     growing T cells that recognize proteins expressed on EBV infected Lymphoma cells and B cells     called LMP-1 and LMP2. These special T cells are called third party LMP 1/2 -specific     cytotoxic T-lymphocytes (CTLs). These LMP-specific cytotoxic      T cells are an investigational product not approved by the Food and Drug Administration.   "
101613|NCT01956071|"     The purpose of this study is to assess full-time workers'impressions and acceptability of a     prototype pedal desk. The pedal-desk is a semi-recumbent (upright) portable pedal mechanism     that allows workers to complete tasks in a traditional seated position.   "
101614|NCT01956058|"     After a curative treatment by radiotherapy for localized prostate cancer, between 20% and 50%     of patients may have a biological relapse as a progressive re -rise of PSA. After prostate     brachytherapy with low flow, this rate is between 2% and 6%. Depending on risk factors     initially present, some patients will have a micro metastatic disease at the time of re-rise,     but others will have a true local recurrence purely intra-prostate. Local recurrence after     radiotherapy is associated with a high incidence of distant metastatic relapse and poor     overall survival. For these reasons, the possibility of offering a local treatment for this     selected population of patients can have a major therapeutic interest and allow changing a     situation often considered palliative to the possibility of a second curative treatment.      Currently, there is no consensus regarding the optimal management of patients with purely     local recurrence after prostate irradiation at first intention. When an external radiotherapy     or brachytherapy is performed as first choice in a patient with prostate cancer, several     remedial treatments have been proposed, with controversial results the decision-making for     clinicians and for difficult patients. These main therapeutic options remedial (surgery,     cryotherapy and brachytherapy) have the potential for complications such as rectal injury,     impotence or incontinence Brachytherapy is a new salvage treatment being evaluated in the     United States (Phase II study of the Radiation Therapy Oncology Group No. 0526). Several     retrospective trials have shown very encouraging results in terms of acute toxicity and     biochemical control in the short term. Thus, a team from Mount Sinai in New York recently     published for the first time 10 years retrospective results with this approach. In their     experience after treatment failures with external beam radiotherapy or brachytherapy, a dose     of 122 Gy was delivered over 90% of the prostate gland. Doing this they observed biochemical     control rates and survival specific of 54 % and 96 %, respectively at 10 years, with an     hormone treatment associated (median 6 months) in 84 % of cases. Four patients had grade 3     toxicity or higher (11%). To reduce the rate of late toxicities the team from the University     Of California San Francisco (UCSF), tested focal brachytherapy guided by functional MRI (MRI     spectroscopy) to re-treat local recurrence after initial brachytherapy as monotherapy or     boost. By delivering 144 Gy on recidivism objectified on MRI, the authors observed that a     minimal dose of 37Gy covered 90 % of the prostate gland to treat the risk of microscopic     disease. Doing this, the rate of observed toxicities and biochemical control appeared     encouraging, with a median follow-up of 2 years, since no grade 3 toxicity was observed and     74% of patients achieved a PSA nadir <0.5 ng / mL without associated hormone. In case of     external radiation or brachytherapy, several attempts proposed to associate an injection of     hyaluronic acid gel to the prostate - rectum interface to spare healthy tissue irradiated and     thus reduce the rate of radiation proctitis. The feasibility of implementing this gel has     been demonstrated in patients with non- irradiated tissues. No inherent toxicity of the     injection of hyaluronic acid gel has been described after prostate brachytherapy first line.     The feasibility of this injection remains unproven to date on patients previously irradiated     externally or by brachytherapy. We hypothesize that the risk of radiation proctitis and     fistulas front prostate could be reduced using this technique in this indication.      We propose to carry out a French prospective multicenter phase II trial combining     brachytherapy remedial with an injection of hyaluronic acid after surgery to reduce the risk     of radiation proctitis and / or recto -urinary fistula in a patient population hyper-     selected with a high probability of isolated local recurrence.   "
101615|NCT01956045|"     How to determine the decision-making capacity of critically-ill patients remain unclear. The     investigator study the differences between standardised evaluation and subjective medical     evaluation.   "
101616|NCT01956032|"     The purpose of this study was to evaluate the use of resources during titration of Duodopa at     home.   "
101617|NCT01956019|"     This study will use diffusion weighted MRI (DWI MRI) and dynamic-contrast enhanced MRI (DCE     MRI) techniques to detect changes in sarcoma tumour vasculature. The main aims of this study     are to correlate histological response of soft tissue sarcoma after pre-operative     radiotherapy with several pre-treatment DCE and DWI MRI parameters and to assess the impact     of these on early response prediction. Detected changes may reflect the sensitivity of the     tumour to radiotherapy and may be associated with long term outcomes after treatment.      15 patients normally having pre-operative radiotherapy as part of their sarcoma treatment     will be recruited to this study.      Patients will have an additional three specialised MRI scans: one prior to the start of     radiotherapy, one during the second week of radiotherapy while on treatment and one scan a     week before surgery but after the completion of radiotherapy.      Post-operatively, results of the histological examination of the sarcoma will be correlated     to both the MRI scan data and outcomes after treatment   "
101618|NCT01956006|"     Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening     cardiovascular disorder, characterised by marked symptomatic limitation and frequent     hospitalization. It is particularly prevalent in older individuals (up to 10% of the     population) and it has become the most common cause for hospitalization in people >65yrs. As     such it is also one of the leading consumers of healthcare spending. Recurrent     hospitalization is frequently due in significant part to the lack of viable therapeutic     options for severe HF. During hospital admission, medications through a drip to give through     a vein (intravenous therapy), is required to improve heart pumping capacity (such as     milrinone).They are frequently used and in many cases prolonged treatment periods of     intravenous therapy are required. In a growing number of cases, there is a need to continue     this treatment at home, however this is particularly costly and often complicated by     intravenous line infection. As such there is an expanding need for therapeutic options in     patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid     release form of oral milrinone were examined, however these studies demonstrated adverse     effects due to its quick release.      This study aims to determine the safety and tolerability of slow release oral milrinone in     advanced HF patients with no further clinical option and to evaluate its effects on HF     status.   "
101619|NCT01955993|"     Fentanyl is a frequently used pain medication in pediatric and adult anesthesia. Although     there are some studies considering the breakdown of oral, transmucosal and intravenous     fentanyl preparations in children, the disposition of fentanyl in pediatric patients has not     been sufficiently described. This study aims to show that the clearance of fentanyl in obese     children and adolescents is increased as compared to children with a normal weight.     Consequently, the elimination half-life of fentanyl is different in overweight and obese     children from that in children having a normal body weight.   "
101620|NCT01955980|"     The study should create data for the selection of a clinically relevant endpoint to assess     the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic     Rhinosinusitis.   "
101621|NCT01955967|"     The aim of this randomized double blind, placebo controlled, crossover study is to     investigate in a prospective way the effect of lidocaine in patients with trigeminal     neuralgia. Included patients will undergo four weekly sessions, two of which with lidocaine     (5mgs/kg) and two with placebo infusions administered over 60 minutes. Effect will be     measured with pain diaries and visual analogue scales.   "
101622|NCT01955954|"     The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS)     in treating the symptoms of panic disorder.   "
101624|NCT01955928|"     The object of this study is to compare internet-delivered treatment for insomnia to a     waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral 2)     waiting-list. Participants in the waiting-list condition receive treatment after the     post-test. The interventions consist of: diary; psycho-education; relaxation exercises;     stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about     sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular     scientific website to fill out online questionnaires. Participants will fill out     questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up.     In this study we are interested in sleep-related worry and daily complaints measured with a     diary. We expect that the online intervention ameliorates both the sleep-related worry and     the daily complaints. Furthermore, we expect that the sleep related worry mediates the effect     of the intervention on sleep- and daily complaints.   "
103411|NCT01932528|"     To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and     its primary metabolite LX1033.   "
101627|NCT01955889|"     Persons with Parkinson Disease (PD) face significant declines in function resulting in     greater disability. Function can improve through participation in exercise, yet many people     with PD are physically inactive. Given that people with PD live long lifespans following     diagnosis; it is essential to include routine exercise into their lives over the long-term.     Physical therapy is effective in improving function in persons with PD. However,     participation in on-going physical therapy indefinitely is not a realistic option due to     limited healthcare resources. Interventions using mobile health technologies allow physical     therapists to stay connected to patients over time potentially improving their ability to     meet the changing needs of patients with PD. Innovative approaches using mobile health     technology may improve outcome; however, the effectiveness of different approaches to improve     function and reduce disability in PD is unknown.      The purpose of this study is to compare the effectiveness of two interventions to improve     function and health-related quality of life in 65 people with PD. In one study group,     participants receive a home exercise program, in written format, to continue on an     independent basis. In the other study group, participants are instructed to continue with an     exercise program, in their home, delivered using videos of the exercises on a computer tablet     device. This use of mobile-Health technology allows the physical therapist to remotely     monitor participants' progress and modify the exercise program to meet the changing needs of     each patient. The long-term objective of this research is to determine the most efficient and     effective way to improve function that can be widely disseminated to persons with PD.   "
101628|NCT01955876|"     This study is a regulatory post-marketing surveillance in Japan, And it is a local     prospective and observational study of patients who have received Fosrenol.      The objective of this research is to collect information on the safety of Fosrenol after its     launching, which means collecting information on adverse events, especially adverse events in     the digestive system including constipation and serious adverse events, and adverse drug     reactions when the drug is administered to the below-mentioned target patients for six     months.      The secondary objective is to collect information on the safety of the drug when administered     for more than six months, which means collecting information on the safety of the drug when     administered for up to 12 months to the target patients who have already been treated with     the drug for six months. And also if at the time of 12 months after administration of     Lanthanum carbonate the dialysis is not conducted, extending its' administration will be     continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is     evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone)     level change.   "
101629|NCT01955863|"     Radical prostatectomy has become the gold standard treatment for prostate cancer.      Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers     around the world start to develop laparoscopic and robotic approach over the past years. The     problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep     learning curve with a high initial complication rate, and the use of robotic assistance     surgery despite of lower learning curve is associated with higher surgical supply and     operative room costs. These costs may have a significant impact on overall cost of prostate     cancer care especially in Brazil.      In Brazil, the open route for radical prostatectomy is still the most frequent approach. One     of the disadvantages of open prostatectomy from the other surgeries is the longest hospital     stay. However, the question of what length of stay after this operation is optimal and     necessary is unresolved. In this trial the investigators have compared a randomized group of     patients that had discharged on postoperative day 2, 1 and same day surgery. The     investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy     (patient discharge in the same day of surgery - average 12 hours of hospitalization)     maintaining patient satisfaction and safety.   "
101642|NCT01955694|"     This study will be conducted in subjects with clinical diagnosis of worsening chronic heart     failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD)     or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least     3 months prior to emergency presentation to hospital using a multi-center, randomized,     adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design.      Primary objective of the study is to investigate efficacy [percentage of subjects with a     relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more     than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of BAY94-8862     given once daily.   "
101630|NCT01955850|"     The object of this study is to compare internet-delivered treatment for insomnia to     face-to-face treatment and a waiting-list. In this study participants are randomized to: 1)     online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention;     3) waiting-list. Both the online and face-to-face interventions consist of: diary;     psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction;     challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with     insomnia will be invited via a popular scientific website to fill out online questionnaires.     Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up,     and 6-month follow-up. Participants on the waiting-list receive online treatment after the     first post-test. The investigators expect that the online-delivered treatment and the     face-to-face treatment are equally effective.   "
101631|NCT01955837|"     To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer     refractory or intolerable to standard chemotherapies.   "
101632|NCT01955824|"     Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of     topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among     physicians, institutions and geographic locations across the globe. Commonly used topical     anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%),     tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the     flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort.     However, the optimal dosage and strength of topical lignocaine that should be used during     fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the     efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing     flexible bronchoscopy.   "
101668|NCT01955356|"     Some studies have revealed that an induced endometrial injury could improve embryo human     implantation in patients with implantation failure.      The purpose of this study is to determine whether the induced endometrial injury could be     beneficial for regular patients undergoing IVF   "
101634|NCT01955798|"     The Veress needle is the laparoscopic entry technique most commonly used among gynecologists.     Direct trocar entry is another method to gain entry to the abdomen that is uncommon to     gynecologists.      This prospective and randomized study will compare the two entry techniques with regard to:        -  Complications related to the entry technique and previous surgeries        -  Time taken to enter the abdomen        -  The number of attempts taken to enter the abdomen   "
101635|NCT01955785|"     Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by     several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and     mechanically ventilated in order to secure a stable PaCO2. This study compares two     ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume     Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies     results in a more stable ICP and arterial CO2 pressure (PaCO2).   "
101636|NCT01955772|"     Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to frequent     secondary malnutrition to metabolic and digestive troubles due to conditioning regimen,     treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft versus     host disease). In the absence of appropriate nutritional support, myeloablative conditioning     lead to a rapid serious denutrition. But, it is known as negative independent prognostic     factor of overall survival of patients who presented malignant hemopathy treated by high-dose     chemotherapy or AHSCT. Furthermore, it increases hospitalisation delay and decreases quality     of life. In AHSCT with myeloablative conditioning, introduction of nutritional support is     recommended. However, type of nutritional support remains not clearly defined. Parenteral     nutrition is user but favour infections and secondary effects potentially decrease by     intravenous glutamine. Few previous studies with low number of patients, mainly retrospective     or combining allo-and auto HSCT had shown feasibility, acceptable tolerance and low cost of     enteral nutrition (EN). A recent prospective no-randomized study in 45 adults patients who     had undergone AHSCT with myeloablative conditioning find a significant decrease of day-100     mortality (5% vs 30%), of infection mortality, of median duration of parenteral nutrition     (PN) and prevalence of GvH (Graft versus Host Disease) grade III-IV in EN (enteral nutrition)     group. These results had to be confirmed by a randomized study. As EN is 4 to 5 more cheaply     than PN, besides mortality/morbidity stakes for the patient, this study could have potential     economic interest.   "
101637|NCT01955759|"     The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone     and statine is better than beta-blocker alone for the prevention of atrial fibrillation after     coronary by-pass surgery.   "
101638|NCT01955746|"     The purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan     through the new genetic study methods.   "
101639|NCT01955733|"     The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult     patients with moderately to severely active rheumatoid arthritis (RA) who have successfully     completed treatment in Trial 1301.1.   "
101640|NCT01955720|"     To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075     dose(s) effective to reverse prolongation of blood coagulation time by dabigatran   "
101641|NCT01955707|"     The primary objective of the study is to determine whether one 300 mg dose of intravenous     (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic     resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or     at >6 to ≤9 hours from when they were last known normal (LKN).      The secondary objectives of this study in this study population are as follows: to assess the     efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess     efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to     assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the     safety of natalizumab in participants with acute ischemic stroke.   "
101643|NCT01955681|"     This is a retrospective, non-interventional, multicenter, observational chart review study to     explore the clinical benefits of retreatment with TKI in the real world.   "
102280|NCT01947348|"     To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction)     has an effect on pain and inflammation associated with Osteoarthritis.   "
101646|NCT01955642|"     Ischemic stroke (AIC) is the leading cause of non-traumatic disability in adults, the second     leading cause of dementia and the third leading cause of death in France.      Clopidogrel is one of the recommended first line in the secondary prevention of AIC non     cardioembolic origin. However recurrences occur in approximately 9% of patients receiving     clopidogrel. Some studies in patients with coronary artery disease have made the connection     between these treatment failures and non-biological response to clopidogrel. This     non-biological response is found for approximately 30% to 50% of patients. Several mechanisms     may explain this non-response. The most accepted mechanism is pharmacokinetic. Indeed,     clopidogrel is a prodrug that requires intestinal absorption by P-glycoprotein (PGP) and a     transformation by hepatic cytochrome into active metabolites. The genetic polymorphism of     proteins involved in these two steps explain the low plasma concentration of active     metabolites and thus the low efficacy of clopidogrel in some patients.      A new pharmacodynamic hypothesis suggests the involvement of platelet alpha 2-adrenergic     receptors. The activation of these receptors potentiates signaling pathway P2Y12 receptor     (channel inhibited by clopidogrel) and helps reduce platelet aggregation inhibiting response     to clopidogrel.   "
101647|NCT01955629|"     Primary Objectives:      Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and     capecitabine (XELOX) combination to be used in the Part 2 of the study.      Study Part 2: To assess the percentage of participants without progression of the disease at     6 months after the start of maintenance therapy with aflibercept single-agent, following the     first-line induction therapy with XELOX and aflibercept combination in participants with     previously untreated metastatic colorectal cancer.      Secondary Objective:      Study Part 2: Include the evaluation of progression free survival, overall survival, response     to treatment, the overall safety (during induction and maintenance therapy) and the     assessment of aflibercept pharmacodynamics and biomarkers parameters.   "
101669|NCT01955343|"     This study is designed to evaluate the importance of the immune cells localization     (distribution) between malignant tumor islets and surrounding stroma and to investigate the     associations between these immune cells as well as cytokines and clinicopathological and     prognostic factors of non-small cell lung cancer (NSCLC) patients.   "
101648|NCT01955616|"     The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinson's     disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The     study will look at how well RM-131 affects the frequency of spontaneous bowel movements over     a 14-day period. The study will also evaluate the safety and tolerability of the study drug     and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic     constipation in patients who are unsatisfied with other therapies they have tried for     constipation.   "
101649|NCT01955603|"     This trial is conducted in Europe. The aim of the trial is to investigate the safety,     tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics     (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects     with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate     (MTX).   "
101650|NCT01955590|"     Posttraumatic stress disorder (PTSD) is a frequently occurring and often debilitating anxiety     disorder resulting from exposure to trauma. Trauma-focused cognitive-behavioural therapies,     such as Eye movement desensitization and reprocessing (EMDR), are generally considered to be     evidence-based treatments for PTSD. Although a majority of patients achieve improvement, a     substantial minority either drop out of treatment, present with residual symptoms following     treatment or fail to make any improvement. Furthermore, a substantial portion of the clinical     trials on PTSD is characterised by major methodological limitations. In addition, there's a     pressing need for research on mediators of treatment outcome. Taken together, these results     highlight the need for methodological rigorous and stringent clinical trials comparing     treatment modalities for PTSD. The first aim of this study is to investigate whether a     treatment not based on the principles of exposure, i.e. metacognitive therapy (MCT) is as     efficient as exposure-based treatments. The second aim to elucidate potential mediators of     treatments effects by incorporating process-related variables.   "
101651|NCT01955577|"     The purpose is to study:        1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an          external ring fixator        2. if vitamin D supplement facilitates fracture healing        3. a possible relation between vitamin D deficiency and the risk of complications and the          time of fracture healing   "
101652|NCT01955564|"     This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort     study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses     of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will     participate in this study, with the first 9 volunteers in each cohort to qualify being     randomized to receive study medication and the remaining 3 to be used as backups/ alternates.     In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will     receive placebo.   "
101653|NCT01955551|"     Evidence-based programs aimed at enhancing parenting skills are effective, and pediatricians     identify many parents who could benefit from such programs. Low-income children have high     rates of behavior problems and their family system and environmental exposures often lead to     cumulative and daunting levels of risk for poor functional outcomes; their parents are highly     likely to benefit from parenting supports. However, low-income families are the most likely     to drop out of parenting interventions, meaning the families and children with the greatest     need receive the least support. Fewer than 25% of low-income families recruited to parenting     programs will participate in even one session, and only about half of these parents will     participate in more than half of the sessions offered. The aims of this trial are:      Aim 1: To test the hypothesis that the provision of motivational interviewing (MI), as     compared to an attention control (AC) condition, will increase the engagement of low-income     parents of preschoolers in an evidence-based parenting skills group (the Incredible Years     Series (IYS)). For this study, the outcome of engagement is operationally defined as     intention to attend IYS sessions, attendance, and satisfaction with the IYS program.      Aim 2: To test the hypothesis that the effect of MI on engagement in IYS will be impacted by     the following moderators: parenting self-efficacy, child behavior problems, and maternal     depression.      The investigators hypothesize that the effect of MI on engagement will be greater among     parents with lower parenting self-efficacy and parents of children with more behavior     problems, but less among parents with more maternal depressive symptoms.      The investigators will use a stratified, randomized controlled trial (RCT) design to evaluate     the impact of MI on parent engagement in a well-validated preventive parenting skills     intervention, the Incredible Years Series (IYS).   "
101654|NCT01955538|"     The aim of this randomised controlled trial is to study two types of physical activities as     add-on treatment, compared to treatment as usual for traumatised refugees. Hereby, the study     will examine the evidence of an often-used treatment modality in a field where very little     research yet has been conducted.   "
101655|NCT01955525|"     This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of     the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible     associations with their cardiovascular profile and to ii) Linkage these data to multiple     electronic healthcare records   "
102281|NCT01947335|"     This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the     procedure.   "
101657|NCT01955499|"     This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib in     treating patients with B-cell non-Hodgkin lymphoma that has returned or not responded to     treatment. Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide with     ibrutinib may work better in treating non-Hodgkin lymphoma.   "
101658|NCT01955486|"     The purpose of this study is to gather more information on Eustachian tube function and     middle-ear pressures during flying. Ten subjects with tympanostomy tubes (plastic tubes     inserted in the eardrums) in their ears or holes in their ear-drums will undergo flight     simulation in a pressure chamber. Their middle-ear pressures and Eustachian tube function     will be monitored at various chamber pressures.   "
101659|NCT01955473|"     This trial is to assess the safety and tolerability of Sym004, administered weekly or     biweekly as monotherapy in Japanese subjects with advanced solid tumors.This study consisted     of two parts, a dose-escalation part (Part-A) and a dose-expansion part (Part-B). In     Part-A, Sym004 will be administered weekly or biweekly as monotherapy in Japanese subjects     with advanced solid tumors. In Part-B, Sym004 will be administered weekly as monotherapy to     Japanese subjects with advanced esophageal squamous cell carcinoma (ESCC) as dose-expansion.     A subject will receive Sym004 administration weekly at a dose that will determined to be the     MTD or a dose that will lower than the MTD and determined to be appropriate with     recommendation by Safety monitoring committee (SMC). The dose going to used in Part-B will be     determined after safety confirmation of weekly regimens in Part-A of this trial.   "
102214|NCT01948206|"     The purpose of the study is to determine whether prolonged paced QRS duration is a marker of     sudden cardiac death in subjects with implantable cardioverter-defibrillators (ICD).   "
101660|NCT01955460|"     The goal of this clinical research study is to find the highest tolerable dose of T-cells     injected with the genes TGFb-DNR and NGFR that can be given in combination with chemotherapy     (cyclophosphamide and fludarabine) and aldesleukin to patients with metastatic melanoma.      This study involves gene therapy. T-cells are types of white blood cells that help your body     fight infections. They may recognize and kill melanoma cells. Researchers want to grow your     T-cells in a laboratory, inject them with TGFb-DNR and NGFR genes which may help them     recognize tumor cells, and then give them back to you by vein. This may help to control     melanoma.   "
101661|NCT01955447|"     The study is designed to determine the extent to which foods containing different levels of     plant-based ingredients affect blood glucose responses in healthy subjects.   "
101662|NCT01955434|"     This phase II trial studies how well second mitochondrial-derived activator of caspases     (SMAC) mimetic LCL161 alone or with cyclophosphamide works in treating patients with multiple     myeloma that has returned or does not respond to treatment. Biological therapies, such as     SMAC mimetic LCL161, may stimulate the immune system in different ways and stop cancer cells     from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether giving SMAC mimetic LCL161 alone or with     cyclophosphamide is more effective in treating multiple myeloma.   "
101663|NCT01955421|"     This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose     erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced     non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control     rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224     eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib     250mg daily in a 1:1 ratio until patients experience disease progression. Independent     assessment of the major endpoints will be completed in a treatment-blinded manner.     Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs.     second-line therapy). Tumor response and progression will be assessed according to RECIST     1.1.   "
101664|NCT01955408|"     Bladder carcinoma is the most common malignancy of the urinary tract. Approximately 75-85% of     patients with bladder cancer present with a disease that is confined to the mucosa or     submucosa. These categories are grouped as non-muscle-invasive bladder tumors(i.e.     superficial tumors).      Bladder cancer is the fifth most common cancer in the United States, with an estimated 67,160     newly diagnosed cases and 13,750 deaths in the United States in 2007. The 5-year survival     rate is 82% for all stages combined. The standard of treatment for patients with superficial     bladder cancer is surgical transurethal resection (TUR) of tumors, with an 80% early success     rate. However, nearly 70% of these patients will develop tumor recurrence, with 25% showing     progression to muscle-invading disease, within 5 years with TUR.      It is therefore necessary to consider adjuvant therapy in all patients. The absolute risks of     recurrence and progression do not always indicate the risk at which a certain therapy is     optimal. The choice of therapy may be considered differently according to what risk is     acceptable for the individual patient and the urologist.      Intravesical chemotherapy and immunotherapy are widely used as adjuvant therapies after TUR,     to prevent recurrence and progression of superficial disease. Systemic therapy is typically     reserved for higher stage, muscle-invading, or metastatic diseases. The urinary bladder is an     ideal organ for regional therapy.      The urethra provides easy access of therapeutic agents to the urinary bladder. The presence     of the specialized asymmetric unit membrane on the urothelium serves as a barrier and limits     the absorption of molecules or particulates into the systemic circulation.      The rationale for intravesical therapy is to maximize the exposure of tumors located in the     bladder cavity to therapeutics agents while limiting the systemic exposure and thereby     limiting the host toxicities; the primary goal is to eradicate existing or residual tumors     through direct cytoablation or immunostimulation. The unique properties of the urinary     bladder render it a fertile ground for evaluating novel approaches to regional therapy,     including local hyperthermia, co-administration of permeation enhancers, bioadhesive     carriers, and gene therapy.      One of the developing treatments for high-risk superficial bladder cancers is the combination     of intravesical chemotherapy and hyperthermia (HT), called chemohyperthermia (C-HT). The most     common form of C-HT uses the Synergo HT system, in which local HT is administered via direct     microwave irradiation of the urothelium by means of a 915-MHz intravesical microwave     applicator. The target intravesical temperature is set between 41.8C and 44.8C and is     measured by five thermocouples integrated in a 20-F treatment catheter. To avoid injury, the     urethra is continuously cooled. Due to extensive global experience with its use and a     significant amount of preclinical data demonstrating improved antineoplastic efficacy when     heated, mitomycin C (MMC) is the most common intravesical chemotherapy agent used in     conjunction with HT.      The most common adverse events during treatment were bladder spasms and bladder pain.     Literature reports bladder spasms in 21.6% of patients, and bladder pain in 17.5%. Bladder     spasms tended to occur more frequently with the prophylactic schedule, whereas pain was     present equally in the prophylactic and ablative schedules but more commonly after the     ablative schedule. In the first days following C-HT, storage LUTS (frequency, dysuria,     urgency, nocturia) (25.6%) and hematuria (6.0%) are the most common adverse events. Most     studies mention that these symptoms were mild and transient, resolving spontaneously within a     few days of treatment. One study described severe cystitis complaints in three patients     (16%), but other studies have not confirmed these adverse events. Two studies report the     development of a contracted bladder and severe urinary incontinence after ablative C-HT.     However, the possibility cannot be excluded that previous transurethral resection and     intravesical chemotherapy might have contributed to this event.      Following the appearance of bothersome storage LUTS, patient should be managed by existing     guidelines. Based on AUA/SUFU Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic)     in Adults Guidelines published in 2012 patients should be diagnosed, followed and treated     according to the suggested algorithm.      In our study, we would like to assess the severity of OAB symptoms and their response to a     standard OAB treatment according to AUA Guidelines for Non-neurogenic OAB as well as to     assess urodynamic study variables in those who didn't respond to a standard medical treatment     and bothered by their OAB symptoms.   "
101665|NCT01955395|"     This research study is evaluating the effects of a mind body medicine intervention called the     Relaxation Response Resiliency Program (3RP) on stress and stress related symptoms in     patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering     multiple myeloma (SMM).      This research study is a supportive care trial. This means that the intervention program may     improve general well-being and comfort, but is not considered a treatment or cure for MGUS     or SMM. It is considered an investigational intervention because the investigators are     examining the effectiveness of a new program - the 3RP - on reducing stress and     stress-related symptoms in patients with MGUS and SMM. Standard management of MGUS and SMM     involves regular monitoring without chemotherapy. Mind-body medicine, as defined by the     National Institutes of Health, focuses on the interactions among the brain, mind, body, and     behavior, and on the powerful ways in which emotional, mental, social, spiritual, and     behavioral factors can directly affect health. The 3RP is a newly designed group therapy     program that through a variety of mind body principles and self-care interventions seeks to     buffer stress and promote psychological resiliency and physical well-being.      This study will examine the effectiveness of the 3RP in reducing stress and symptoms     associated with stress in patients diagnosed with MGUS or SMM. Data from this study will also     be used to assess changes in gene expression that result from 3RP intervention, particularly     genetic pathways that are known to be dysregulated in MM.   "
101684|NCT01955148|"     This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can     be used to advance prediction of spontaneous preterm birth (sPTB). This will be a prospective     observational multi-center study with approximately 15 to 20 US sites, and approximately 1210     subjects evaluating the clinical utility of the Rapid fFN 10Q system for preterm birth risk     assessment. A single fFN specimen will be collected from each subject between 16 weeks, 0     days and 21 weeks, 6 days. The primary and secondary maternal outcome measures will be     determined based on the date of delivery and the estimated date of confinement (EDC), which     will be evaluated in a standardized manner.   "
101685|NCT01955135|"     Premature infants experience more respiratory problems after surgical procedures. The     investigators aimed to compare general anesthesia with sedation on the need for     post-operative mechanical ventilation in infants undergoing retinopathy of prematurity     surgery.   "
102773|NCT01940939|"     1. Exploration of rTMS on working memory and cognitive impairment symptoms of schizophrenia          treatment and mechanism.        2. Analysis of rTMS high-frequency stimulation to the improvement of negative symptoms and          psychotic symptoms.   "
101666|NCT01955382|"     Background:      - Malaria is caused by small parasites carried by some mosquitoes. People can get malaria if     an infected mosquito bites them. Malaria destroys red blood cells. Most malaria is mild, but     some children develop severe malaria, which kills about 660,000 people annually. About 9 in     10 who die of malaria are Sub-Saharan African children, most under 5 years old. Scientists     can save many lives if they find out how to prevent or relieve severe malaria.      Objective:      - To know if a common medicine called activated charcoal can reduce severe malaria symptoms.      Eligibility:      - Children 2 to 11 years old with mild malaria who live in Kenieroba, Mali.      Design:        -  For the first 2 days and nights, participants will stay in the hospital.        -  They will have their medical history taken, and a physical exam.        -  Blood will be drawn from a thin tube inserted in their hand or forearm. This will be          done 3 times overall. A drop of blood will be taken from a finger prick 12 times          overall.        -  An antimalarial drug will be injected into the tube in the arm 4 times. Each time the          drug is given, participants will drink a small cup of either water or activated          charcoal.        -  For the following 3 days, participants will take an antimalarial pill.        -  On day 7, participants will visit the hospital. A drop of blood from a finger prick will          be tested for malaria parasites.   "
101667|NCT01955369|"     There is a lack of prospective and population-based epidemiological data on amyotrophic     lateral sclerosis in Germany so far. The purpose of this registry is to investigate the     incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German     state of about 4 million inhabitants.   "
101670|NCT01955330|"     OBJECTIVES:      The objectives of the year study are two-fold:        1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft          and stent of patients who have already had robotically-assisted Hybrid CABG surgery          using CTA and MPS-MIBI.        2. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid CABG          surgery   "
101672|NCT01955304|"     This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of     4mg fruquintinib in normal healthy subjects.   "
101673|NCT01955291|"     The aims of the study is to explore whether the rehabilitation of the upper extremity     performed in interaction with a virtual environment could improve motor function in     post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the     traditional neuromotor rehabilitation treatment.   "
101674|NCT01955278|"     Introduction Parastomal hernia is the most common complication related to colostomies. The     variability of the diagnostic criteria, the fallow up time and sometimes subclinical     dimensions, detectable only with imaging, explain disparate figures cited in the literature     (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider     that actually, almost all patients present parastomal hernia in the long-term fallow up (3).      Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing     since the beginning the weak peristomal area of the abdominal wall. Existing scientific     evidence, although positive, is limited and does not allow to clarify some controversial     issues as the type of prosthetic mesh to be used and the optimal position of the mesh in     relation to the abdominal wall (4-8).      The use of laparoscopic approach in colorectal surgery is increasing and also sets technical     changes to the placement of the mesh. To date, there are some technical notes (9) and two     published prospective, observational studies that include patients underwent laparoscopic     surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is     used, with encouraging short-term results, but they need more scientific support.      Study Design This is a prospective, randomized, single center, clinical study where the     sample is represented by patients undergoing elective laparoscopy assisted colorectal     surgery, with the creation of a permanent end colostomy. Patients who accept to participate     and are suitable for inclusion to the study will be randomized into one of the two branches     consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive     end colostomy reinforced by retromuscular mesh Ultrapro.      Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent     parastomal hernia end colostomy versus realization of end colostomy by conventional     technique.      Primary Objective: Compare the incidence of parastomal hernias between groups during the     monitoring period.      Secondary objectives: Compare the overall and specific postoperative morbidity and mortality     between groups, compare the difference in surgical time between the conventional technique     and the prosthetic mesh group, compare hospital stay between the groups.   "
101686|NCT01955122|"     To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard     view colonoscopy.      To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view     colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and     overall procedure time will be analyzed and reported for each group.   "
101687|NCT01955109|"     The objectives of this open-label follow-up study for subjects who previously were randomized     and have completed the VIPES study for the treatment of peanut allergy, are:        -  To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.        -  To evaluate the safety of long-term treatment with Viaskin Peanut.        -  To evaluate sustained unresponsiveness to peanut after a period of 2 months without          treatment in subjects showing desensitization to peanut after treatment with Viaskin          Peanut.   "
101675|NCT01955265|"     Background      A physically active lifestyle is crucial for development but a large number of youth in Hong     Kong are sedentary and do not meet the International (World Health Organisation) and the     local (Leisure and Cultural Services Department) recommendation for physical activity. On the     other hand, the evidence for implementing positive youth development programme through     physical activity and sports is elusive.      Purpose      This study aimed to promote physical activity and sports amongst adolescents in Hong Kong     through a structured sports mentorship intervention. The study also aimed to investigate the     effect of such programme in positive youth development.      Methods      This was a two-phased study with Phase I being the preparatory stage and Phase II being the     implementation stage. In Phase I, questionnaire surveys and focus group interviews were     conducted to understand the relevant perceptions and opinions amongst various stakeholders     (e.g. teachers, parents, and students). The data collected was analysed to inform the design     and planning of the Phase II intervention. Phase II was an experimental trial of our sports     mentorship programme. Participating students were divided into intervention and control     group, where the former received the sports mentorship programme and the later did not. The     intervention was 18 weeks long providing an additional 90 minutes of active time per week for     all students in the intervention group. Programme mentors were trained and supported in     reference to previous evidence. Intervention effectiveness were evaluated by comparing the     outcomes between intervention and control group.   "
101676|NCT01955252|"     The trial that the investigators are proposing is a pilot study to determine the effect of     the new WHO-yaws eradication strategy in Lihir Island (population 18,000), Papua New Guinea.     New treatment policies were developed by WHO in 2012 to replace those of the 1950s. The     recommended practice is to offer an initial MDA with azithromycin to the entire population,     followed by resurveys every 6 months to detect and treat remaining cases.We will use serology     surveys, clinical surveys and ulcer aetiology studies to measure the effect of mass     azithromycin treatment on the community burden of yaws infection.   "
101677|NCT01955239|"     Rationale:      Radiation-induced parotid gland dysfunction, often leading to xerostomia is the     most-frequently occurring side-effect with a major impact on patient-reported quality of life     after radiotherapy for head and neck cancer (HNC). Therefore, treatments for HNC are     currently optimized to minimize the mean dose to the parotid glands. Though this resulted in     a significant reduction of toxicity, 30%-40% of the patients still develop sustained parotid     gland dysfunction and xerostomia.      However, in animal studies the investigators found that the dose to the sub-volume of the     gland containing the parotid gland stem cells is a better predictor for dysfunction than the     mean dose to the whole gland. Subsequently, this finding was confirmed in a retrospective     analysis in patients. Therefore, a reduction of dose specifically in this sub-volume of the     parotid glands of patients is expected to further reduce the risk of parotid gland     dysfunction and xerostomia.      Objective:      To test the hypothesis that parotid gland stem cell sparing intensity modulated radiotherapy     in HNC patients reduces the risk of parotid gland dysfunction and xerostomia as compared to     conventional parotid gland sparing intensity modulated radiotherapy.      Study design:      Double-blind prospective randomized trial (51 patients per arm). Study population: Patients     treated for tumours in the head-and-neck region with curative radiotherapy, with or without     the addition of chemotherapy or cetuximab.      Intervention: Patients randomized into the experimental arm will receive a treatment in which     the radiation dose to the parotid gland is re-distributed to minimize dose to the sub-volume     containing the stem cells, while keeping the same mean dose to the parotid gland as a whole.      Main study parameters/endpoints:      Primary endpoint is parotid gland salivary secretion. Secondary endpoints are patient- and     physician-rated xerostomia.   "
101678|NCT01955226|"     The purpose of this study is to determine whether Tegaderm CHG clear dressing reduces the     number of unscheduled central catheter dressing changes compared to standard clear Tegaderm     IV dressing in pediatric patients between the ages of 2 months to 18 years with central     venous access. Secondarily, we will monitor contact skin irritation and central line     associated blood stream infections.   "
101679|NCT01955213|"     Methylnaltrexone for the treatment of opioid-induced constipation in the setting of     palliative or hospice care, is significantly more effective than placebo (1). However, in     both the randomized and the open-label phase of the multi center trial showing this favorable     outcome, the drug produced rescue-free laxation in only about half of the patients (2). There     may be several reasons for this result, since constipation in palliative care patients often     has multiple simultaneously occurring causes.      Assuming that constipation of the non-responders is still opioid-induced, one of the possible     reasons for not responding to methylnaltrexone could be that central actions of opioids     contribute to constipation by reducing motility of the intestines through direct actions in     the spinal dorsal horn (2). However, as methylnaltrexone is a µ-receptor antagonist and not     all opioids are solely µ-receptor agonists another reason may well be that successful     laxation is determined by the receptor-profile of the specific opioid the patient is using.      Opioids do not only influence bowel functioning, but also immune system functioning and     angiogenesis. Methylnaltrexone possibly antagonizes these changes, therefore this study will     also investigate the influence of methylnaltrexone on immunologic and angiogenic parameters.   "
101680|NCT01955200|"     The purpose of this study is to determine that for patients who received stent implantation     but present low response to regular anti-platelet treatment, whether 1-month intensified     anti-platelet treatment by replacing clopidogrel with ticagrelor (TCL) is superior to double     dose clopidogrel or adding cilostazol.   "
101681|NCT01955187|"     In this study, investigators will evaluated the long-term efficacy and safety (two years) of     Tacrolimus-Rituximab (RTX) therapy compared to Methylprednisolone-Cyclophosphamide (CYC)     therapy in patients with primary Membranous Nephropathy (MN).      PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus leads to a greater     increase in the proportion of primary MN patients with Complete or Partial Remission when     compared with patients receiving standard treatment. It will be assessed 24 months after the     beginning of treatment.      Phase of the trial: and design: Phase III study, open label, randomized, and active     controlled trial.      This study will have 3 stages: screening and recruitment of patients for 18 months, treatment     period for six months in corticosteroids plus CYC group and 9 months in Tacrolimus-RTX group,     and finally post-treatment follow-up period until to complete 24 months of follow-up since     initial treatment.      This study will compare the standard therapy for primary MN patients with nephrotic range     proteinuria (active control of steroids plus CYC) with a novel sequential therapy of     tacrolimus and RTX, an approach of potential high efficacy, low toxicity and more acceptable     safety profile.   "
101682|NCT01955174|"     This study aims to evaluate the efficacy and the safety of endoscopic injection of 100 IU of     botulinum toxin (BTX) in the distal esophagus in patients with symptoms related to     hypercontractile esophageal motility disorders.   "
101683|NCT01955161|"     To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic     treatment of patients with mild-to-moderate Alzheimer's disease (AD).   "
101689|NCT01955083|"     1. Background：The methods of anti-snore (treatment of snoring ) can be divided into          conservative, invasive and minimal invasive treatment. IN brief, minimal invasive          surgery involving radiofrequency and pillar implant demonstrates significantly          improvement of snoring without major complication. Previous studies usually evaluated          snoring through subjective measures such as visual analog scale visual analog scale.          Rare reports analyzed snore sound instrumentally and no report demonstrates the          correlation between subjective perception and objective assessment of snoring before and          after surgical intervention.        2. Purposes：             1. Development of snore sound spectrum.             2. Exploration of the correlation between subjective perception and objective               assessment of snoring.             3. Comparison of changes in snoring before and after minimal invasive surgery and               between two kinds of MIS to have a understanding of surgical impact in subjective               and objective measurement.        3. Method：We plan to enroll 30 subjects diagnosed by polysomnography as simple snoring or          mild OSA with major complaint of snoring and favorable anatomic structure for minimal          invasive surgery. All eligible subjects will be instructed the purpose, process and all          related rights of this study and sign inform consent in outpatient clinic. Subjects          start to complete Snore Outcome Survey (SOS, a validated questionnaire) and visual          analog sure of snoring (VAS). Objective overnight snore sound recoding is arranged in          sleep center. Subjects then receive minimal invasive surgery：radiofrequency or pillar          implant of the soft palate by randomization. Both radiofrequency and pillar implant are          common techniques in treating snoring and performed under local anesthesia as an          outpatient procedure on sitting position. All subjects received repeated snore sound          recording and completion of SOS and VAS three months after MIS.        4. Outcomes             1. Development of snore sound spectrum in sleep-disorder breathing patients.             2. Correlation of parameters between snore sound recording (loudness, frequency,               count, regularity, etc ) and clinical parameters.             3. Correlation between objective (snore sound analysis) and subjective (SOS,VAS)               assessment of snoring.             4. Comparison of changes in snoring (particular in objective assessment) after               radiofrequency or pillar implant.             5. Comparison of changes in snoring between radiofrequency and pillar implant.   "
101690|NCT01955070|"     This is a prospective cohort study in which the standard verbal informed consent process for     ketamine sedation is compared to a multimedia informed consent process. The goals include     determining if parents prefer a multimedia consent process and evaluating the effectiveness     of multimedia consent process.   "
101691|NCT01955057|"     Persistent smoking after lung cancer has been the subject of medical, therapeutic and     epidemiological publications for twenty years of research. Continued persistent smoking is     all the more a problem for oncologists as there is evidence that smoking cessation, with lung     cancer, gives therapeutic benefit. Quitting smoking can improve the response to treatments     (chemotherapy, radiotherapy, surgery), quality of life and overall survival. However many     patients refuse adhesion to tobacco cessation. Daily practice leads us to the hypothesis that     adhesion differences aren't related to the denial of medical information, nor to resignation     or to nicotine dependence. Patients who continue smoking seem to face a form of impossibility     to wean. Cigarette seems to be felt as a part of their body in their narration and     description of their body image.   "
101692|NCT01955044|"     The purpose of this study is to determine if buccal administration of a concentrated     formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain     docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.   "
101693|NCT01955031|"     Severity of diabetes is related to the development of disabling and costly complications     (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic     education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes Mellitus.     Despite these recommendations, patients often have difficulties to implement dietary     recommendations every day. The objective of EDUC@DOM is to help people with diabetes to     improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic     complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring     program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of     the patients. It is expected that our program leads to a better monitoring of health status,     a greater adherence to medical and non-medical prescriptions, an empowerment of the patient,     and as a consequence, a more efficient health care consumption.   "
101694|NCT01955018|"     Asbestos fibers were intensively used throughout the 20th century and remain prevalent in     developing countries. However, asbestos exposure induces a variety of benign and malignant     pleural and lung diseases. The most common asbestos-induced neoplasm is lung cancer.     Moreover, thin-section computed tomography (CT) is more sensitive than a chest x-ray for     detecting early asbestos-related conditions. Increased exposure to radiation underpins the     consequences of cancer induction. However, reducing CT doses increases image noise from the     filtered back projection (FBP) reconstruction. Strategies to reduce radiation exposure     include the use of iterative reconstruction algorithms. A new algorithm called VeoTM (General     Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70% compared with     the gold standard FBP model. Moreover, Veo improves spatial resolution with excellent     detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to 0.3 mGy.      The objective of the present study is to compare Veo with the gold standard FBP for detecting     pulmonary asbestos-related conditions among workers previously exposed to asbestos.     Comparisons included radiation delivered and image quality.   "
101695|NCT01955005|"     This study aims to conduct a pilot of an intervention to improve care coordination between VA     and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record,     My HealtheVet (MHV). Participants will be randomized to receive either training on 1) how to     use My HealtheVet to share VA health information or 2) training on how to how to search the     Internet for health information and decide which Internet sites have good quality     information. The investigators predict that Veterans who receive the My HealtheVet training     will have fewer medication errors and duplication of services between the VA and outside     providers.   "
101696|NCT01954992|"     The study is designed to assess whether glufosfamide provides additional survival benefit as     compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already     progressed or failed therapy on a gemcitabine based first line regimen.   "
101705|NCT01954875|"     The etiology of many neurodegenerative diseases is unknown. A few studies have suggested the     role of infection in the gastrointestinal tract in the etiology and pathogenesis of     neurological diseases such as idiopathic Parkinson. For example, infection with Helicobacter     pylori has been suggested to play a role in Parkinson disease. In addition, bacterial     pathogens such as spirochetes and bacterial products such as cyanobacterial toxins have been     speculated as the contributing factors in the development of amyotrophic lateral sclerosis     (ALS). The effect of microbial composition of the gut in the pathogenesis of ALS is     suspected. The difference in the bacterial profile of the gut has been documented in diseases     such as inflammatory bowel disease and obesity.      The goal of this IRB protocol is to create a human tissue bank and to obtain patients'     demographic information for future investigation of the role of bacterial pathogens and the     role of gut flora composition in the development of neurodegenerative diseases including but     not limited to ALS, Parkinson's disease, and multiple sclerosis.   "
117744|NCT01744743|"     To assess the effect of universal preconception hypothyroidism for maternal pregnancy     outcome, and 0-3yrs offspring neurocognitive ability and IQ score.   "
101697|NCT01954979|"     The participant is invited to take part in this study because they have chronic Graft versus     Host Disease (cGVHD) that is not responding to standard treatment with steroids. This     research study is a way of gaining new knowledge about the treatment of patients with cGVHD.     This research study is evaluating a drug called abatacept.      Abatacept is a drug that alters and suppresses the immune system. Abatacept is approved by     the Food and Drug Administration (FDA) for the treatment of moderate to severe active     rheumatoid arthritis in adults and of severe juvenile idiopathic arthritis (JIA) in patients     who have failed prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). These are     autoimmune conditions, ie caused by an overactive immune system that attacks normal tissues     and organs. It is currently being tested in a variety of other autoimmune conditions. In this     case it is considered experimental.      cGVHD is caused by the donor cells attacking various organs of the recipient. The     investigators try to minimize this immune attack by using corticosteroids such as prednisone.     In severe cases prednisone is not sufficient and other immunosuppressive medications are used     in addition in order to more efficiently control cGVHD and to limit the dose and consequently     the multiple side-effects of corticosteroids. This study is being done to determine if the     use of abatacept is safe in patients with cGVHD and if it can facilitate a better control of     cGVHD.      During this study the participants will be evaluated for side effects from the treatment with     abatacept, and for response of the cGVHD to the treatment. There will be two groups of     participants in the study. The first group will be treated at a relatively low dose of     abatacept. If this is found to be safe then the second group will be treated at a higher     dose. Three to four tablespoons of blood will be drawn at every 2 week visit in order to     determine your blood counts, kidney and liver function. Some of the blood will be used in a     research lab in order to study measures of your immune system and how they might be affected     by the treatment.   "
101698|NCT01954966|"     The purpose of this study is to learn whether a sex hormone called progesterone is helpful in     reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging     to measure possible effects of progesterone on certain neurochemicals. These neurochemicals     are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and     progesterone affect these brain chemicals.      Individuals wishing to participate in this study must be medically healthy men or women who     smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental     illness or use drugs other than nicotine and marijuana. Participants cannot have any     implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants     must not have peanut allergies and must never have had a reaction to progesterone. Finally,     participants cannot be taking any medications for anxiety, depression or insomnia.   "
101699|NCT01954953|"     This study aims to characterize Usher patients in order to correlate this data with genetic     information.      Tasks:        -  Standardization and improvement of Usher syndrome diagnosis: refine and elaborate          special tests of visual and otological function in association with genotype that enable          to determine the most significant markers for Usher disease progression and therapeutic          effect.        -  Perform genotype and phenotype correlations in Usher syndrome patients        -  Develop and maintain database for phenotypically and genotypically well-characterized          patient cohorts, suitable for future therapeutic trials   "
101708|NCT01954836|"     Hypothesis: Fasting before (48h) and one day after chemotherapy may protect normal cells from     the adverse effects of chemotherapy. Design: Within a randomized controlled pilot trial 30     female patients with gynecological cancer (ovarian and breast cancer)and 4-6 scheduled     chemotherapies will be randomized to fast 60-72 hours during the first half of chemotherapies     or during the second half of chemotherapies and to proceed normocaloric food intake during     the other cycles.Sequence of fasting and normocaloric food intake will be randomized.     Assessments of adverse effects, quality of life and laboratory values take place 24 and 7     days after each chemotherapy. Statistical analyses compare summarized differences of fasted     and non-fasted chemotherapy cycles.   "
101700|NCT01954940|"     Whole-body vibration therapy (WBVT) is a novel, non-pharmacological intervention aimed at     improving muscle strength and endurance as well as bone density. It holds promise for     children with neuromuscular disorders such as Duchenne muscular dystrophy (DMD) since muscle     weakness results not only from muscle breakdown but also physical inactivity and muscle     disuse atrophy. Weak DMD patients may increasingly limit their physical activity due to fear     of falling or loss of independence (e.g. difficulty rising to stand without assistance).     Prolonging the length of time boys with DMD are ambulatory is important for delaying     complications of this disease (lung hypoventilation, scoliosis) as well as maintaining bone     health. We propose to conduct a pilot study of WBVT in young boys with Duchenne muscular     dystrophy (DMD). The primary outcome will be to document safety and feasibility of WBVT in     this patient population. The secondary outcomes will evaluate changes in muscle strength and     endurance. Bone health will also be examined as part of routine clinical care. The study will     include 20 ambulatory boys with DMD; patients will be randomized (1:1 allocation) into 2     groups: WBVT treatment or no WBVT treatment (controls). Treatment groups will consist of 10     boys undergoing daily WBVT in an 8-week, open-label trial.   "
101701|NCT01954927|"     This is a phase II double-blind placebo-controlled clinical trial evaluating the effect of     gabapentin when added to standard pain management for patients with sickle cell disease     experiencing acute pain crisis in the ambulatory care setting.      Sickle cell pain is different for every patient. Some patients get complete relief from     routine pain medicines, and others need more time or more doses of pain medicines before the     pain goes away completely. It is known that humans have many types of pain, including     something called neuropathic pain. Neuropathic pain in other conditions (such as diabetes)     has been treated successfully with a medicine called gabapentin. The investigators in this     study suspect that some sickle cell pain is a combination of pain types. They would like to     see if adding gabapentin to the usual pain medicines makes pain go away faster or more     completely.      Primary Objective:        -  To assess the analgesic efficacy of gabapentin vs. placebo for pain during          vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD). A response          to study drug will be defined by a decrease in pain score of ≥ 33% between presentation          to the acute care setting and assessment at 3 hours post administration of study drug.      Secondary Objective:        -  To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC          between presentation to the acute care setting and assessment at 3 hours post          administration of study drug in the gabapentin vs. placebo groups.   "
101702|NCT01954914|"     With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does     not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are     therefore called poor mobilizers. A generally accepted optimum CD34+ PBSC dose for     allogeneic transplantation is > 4.5 x 106/kg body weight of the recipient. The minimum total     CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective of     this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in     allogeneic stem cell donors with a poor CD34+ cell yield after the first day of peripheral     blood stem cell collection.   "
101703|NCT01954901|"     The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT)     plus standard wound care is more effective than standard wound care alone in the rate of     healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2     diabetic lower extremity ulcers.   "
101704|NCT01954888|"     The first purpose of this study is to compare the effectiveness of the stellate ganglion     block realized with two different approaches (blind and ultrasound-guided) in patients with a     diagnosis of complex regional pain syndrome.      The second purpose of this study is to determine the safest approach and to compare the     safety profiles of the two approaches.   "
101706|NCT01954862|"     Insufflation of the colon, usually with room air, is necessary to distend the lumen for     exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been     shown to decrease symptoms of abdominal pain or discomfort during the procedure and     particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal     mucosa and exhaled through respiration. AI colonoscopy has usually been the reference     standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was     compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion     of water to facilitate insertion to the cecum.      WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water     is infused during the insertion phase of colonoscopy, with removal of infused water     predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails     complete exclusion of insufflation, removal of residual colonic air pockets and feces, and     suction of infused water predominantly during insertion to minimize distention. During the     withdrawal phase insufflation is used to distend the colonic lumen.      In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion     of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or     CO2 insufflation were employed.      Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation     during withdrawal) were effective in both studies in decreasing sedation requirement, pain     and tolerance scores, with patients' higher willingness to repeat the procedure.      Until now no direct comparison has been made within a single study about pain score during     colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI.      In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI     methods will decrease pain score during colonoscopy, with reduction of sedation requirement,     and that WE will achieve the best result. This comparative study has also the aim to test the     respective peculiarities of each method.   "
101707|NCT01954849|"     This study investigates the efficacy of a proprietary probiotic formulation comprising 6     strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11     and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a     prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this     study will be randomly assigned to receive either the probiotic treatment or a placebo, both     in the form of a dissolving lozenge; for which the placebo is exactly the same shape,     texture, taste, and composition as the probiotic treatment, but does not contain the active     probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen     for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque     scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days.     They will also be assessed for the same measures at day 56, following a 28-day wash-out     phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of     changes in microbial pathogens and/or inflammatory cytokines.   "
101745|NCT01954355|"     The primary aim of this trial is to establish the maximum tolerated dose (MTD) and the     recommended phase II dose (RP2D) of LDE225 given in combination with standard doses of     paclitaxel in patients with advanced solid tumors. In addition, the preliminary anti-tumor     activity of this combination will be assessed, in particular in ovarian cancer.   "
102267|NCT01947517|"     The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a     higher rate of retention than Superflex punctal plugs (Brand B).   "
101709|NCT01954823|"     Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young     adults, with onset usually at the age 20-40. Disease modifying therapies are available to MS,     as well as drugs to improve patients' symptoms.      Choosing the optimized treatment for each patient is a challenge to neurologists since     predictive biomarkers for therapy are yet to be validated and approved. Current therapy     decisions are based predominantly on clinical evaluation of disability and disease relapses.     Adherence to treatment in MS is sub-optimal.      Over the past few years a growing involvement of patients in their healthcare is noted,     specially in chronic diseases, and Patient Reported Outcomes (PRO) are being incorporated as     part of therapy evaluation.      Several electronic patients diaries to track adherence to therapy, PRO and drugs side effects     in diseases such as epilepsy are available. A mobile interactive patient diary (e-diary)     tailored for persons with MS was developed. Users can enter data on drugs intake, drugs-side     effects and disease symptoms and receive reminders regarding adherence to treatment.      The aim of this study is to assess the benefits of the use of an e-diary for MS patients on     healthcare. In order to achieve this goal, 80 MS patients will be randomized into two groups:     a study group with access to the e-diary and a control group. After a period of one year,     satisfaction with the e-diary will be assessed. The effect of the use of the e-diary on     quality of life, on clinical outcomes and on adherence to therapy will be evaluated by     comparing the two groups.      This study will indicate the possible contribution of an e-diary for the evaluation of drugs     safety and efficacy and of patient adherence to therapy, to be applied in clinical trials and     towards improvement of MS patient' care.   "
101710|NCT01954810|"     This study has aim to describe the immune response to the second dose of Japanese     encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV     5 years ago.   "
101711|NCT01954797|"     The purpose of this observational study is to examine the effects of 4-weeks of physical     fitness training in patients with subacute ischemic stroke on cerebral imaging and     blood-derived biomarkers.   "
101712|NCT01954784|"     This phase I trial studies the side effects and best dose of lenalidomide after donor stem     cell transplant and bortezomib in treating patients with high-risk multiple myeloma. Giving     low doses of chemotherapy and total-body irradiation before a donor stem cell transplant     helps stop the growth of cancer cells. It may also the patient's immune system from rejecting     the donor's stem cells. The donated stem cells may replace the patient's immune cells and     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the     transplanted cells from a donor can also make an immune response against the body's normal     cells. Giving a bortezomib at the time of transplant may stop this from happening. Biological     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop     cancer cells from growing. Giving lenalidomide after donor stem cell transplant may be an     effective treatment for multiple myeloma.   "
101713|NCT01954771|"     Self-monitoring of blood glucose (SMBG) is a common way to assess glycemic control in     diabetes management. Multiple times of blood glucose measurements by fingerstick in the same     day are of tough challenge to it. The changes and variations of glucose excursion in senior     diabetics with Coronary Artery Disease (CAD)involve a safety issue besides glycated     hemoglobin (GHb) value. The goal of this study is to explore modified SMBG protocols for     precisely monitoring and predicting glycemic excursion, variability in senior type 2     diabetics with CAD.   "
101714|NCT01954758|"     This project seeks to demonstrate the clinical value of the personalised diagnosis of the     endometrial factor in infertility.   "
101715|NCT01954745|"     This research study is evaluating a drug called cabozantinib as a possible treatment cancer     of the bile duct. Cabozantinib is a drug that targets specific pathways inside the cells of     the body. By blocking the c-MET and VEGFR2 pathways from sending signals, cabozantinib may     prevent cells from multiplying. This drug has been used in other research studies and     information from those other research studies suggests that this drug may help to stop the     growth of bile duct cancer.      In this research study, the investigators are looking to see how well cabozantinib works in     slowing the growth of bile duct cancer. The investigators are also assessing the safety and     tolerability of cabozantinib in participants with this type of cancer.   "
101716|NCT01954732|"     This randomized clinical trial studies metformin hydrochloride in treating patients with     pancreatic cancer that can be removed by surgery. Metformin hydrochloride may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
101717|NCT01954719|"     The purpose of this prospective randomised study was to determine the effect of routine     cervical dilatation during elective caesarean section on maternal morbidity   "
101718|NCT01954706|"     Hormone receptor-positive tumors are the most common breast cancers in postmenopausal women,     and drug therapies, which block the production or effects of estrogen, are the mainstay of     treatment in these patients. Due to their effectiveness in postmenopausal women, aromatase     inhibitors (AIs) are the standard of care for long-term estrogen suppression in these     patients. Estrogen deficiency, however, results in multiple side effects. Some of the most     common side effects in women taking AIs are joint and muscle aches, which promote physical     deconditioning. Because of the long term use of AIs in postmenopausal breast cancer patients     and the improvements in cancer-related outcomes that are observed with their use, identifying     methods to reduce these side effects to maintain adherence to treatment is important.     Exercise interventions in breast cancer patients also improve quality of life and reduce     fatigue. Understanding the role of exercise in AI side effect prevention will allow us to     translate these findings into therapy guidelines.   "
101719|NCT01954693|"     This is a single centre, two-arm, individually randomised, Phase II, double- blind,     placebo-controlled trial of RAD001 (Everolimus) versus placebo in the treatment of     neurocognitive problems in patients with tuberous sclerosis (TSC). The IMP is a licensed     medicine in this patient group but for a different target of effect. The current trial is a     proof of principle study for memory and executive function outcomes.      Following an eligibility visit, patients will be scheduled for baseline visit and     randomization. They will then be followed up for 6 months undergoing both safety and     neurocognitive assessments whilst taking either the placebo or study drug.      48 patients aged 16 to 60 years with tuberous sclerosis (TSC) who have IQ > 60 and a     significant deficit in one or more primary outcome measures will be randomly allocated in a     ratio of 2:1 to either RAD001 (Everolimus) or Placebo.   "
101720|NCT01954680|"     The main aim of this study is to test a new, non-medication computer-based potential     treatment for bipolar disorder in children and adolescents.      In the study, children and adolescents with bipolar disorder will come to our lab at Bradley     Hospital 2-times per week for 8-weeks to play a custom computer game designed to retrain     the brain--to build a skill that my work has shown is impaired in children/adolescents with     bipolar disorder.      Before and after this 8-week trial, children will have a special magnetic resonance imaging     (MRI) scan.      This is a test of feasibility--meaning we want to see if the 8-week trial results in brain     changes.      If it does, we will conduct a second study to see if it improves how bipolar children     function--i.e., if it helps their illness.   "
101721|NCT01954667|"     evaluate the impact of different anthropometric measures on clinical and endoscopic severity     of GERD and its relation to serum leptin.   "
101722|NCT01954654|"     The purpose of this study is to determine whether accelerated treatment with custom-made     compression sleeve is more effective than standard procedure in the treatment of mild and     moderate arm lymphedema secondary to primary cancer treatment.   "
101723|NCT01954641|"     Purpose: African American cancer patients, as compared to their White counterparts, continue     to initiate treatment later and remain less apt to undergo complete treatment; fueling worse     treatment outcomes including shorter survival. The concepts of transparency and     accountability, as mechanisms of systems change have been applied for decades by     anti-racism organizations to civil rights and social change. Yet, the application of these     concepts to health systems' change and unequal treatment has rarely been done. The Greensboro     Health Disparities Collaborative and two Cancer Centers have joined together to specify     structures built into cancer care systems that make cancer care vulnerable to institutional     racism and investigate how they can be changed to reduce racial inequity in quality and     completion of treatment for Stage 1-2 breast and lung cancer patients.      Participants: White and African American patients with first diagnosis of Stage 1-2 breast     and lung cancer, with intention to treat, and their cancer care staff at 2 cancer centers.     The 2 cancer centers are Cone Health Cancer Center (CHCC) in Greensboro, North Carolina and     the University of Pittsburgh Medical Center (UPMC) Hillman Comprehensive Cancer Center in     Pittsburgh, Pennsylvania.      Procedures (methods): Using a 5-year interrupted time-series, with an embedded randomized     control trial (RCT) study design, we will test the effectiveness of the ACCURE intervention     components. Having received Institutional Review Board approval for Phase 1, we completed a     5-year, retrospective review of de-identified Electronic Medical Record data to establish a     baseline of repeated outcome measures, convening of an expert committee to design the     intervention, and design of the real-time, electronic breast and lung cancer registry coupled     with dummy testing of the registry system.      The randomized trial will compare patients who receive usual care to those who receive visits     and calls from a trained ACCURE Navigator, who is well versed in issues specific to breast     and lung cancer and trained to serve as a two-way communication bridge to optimize the cancer     care system's accountability and transparency for equity in quality of care. Given     unintended, but likely variation in implementation of the ACCURE intervention by the two     Cancer Centers (at our two research sites), 6 elements of implementation and their potential     effect on outcomes will be documented through a process evaluation.   "
101724|NCT01954628|"     The primary objective of this study is to evaluate the effect of 12 weeks of treatment with     once daily administration of AQX-1125 compared to placebo in subjects following exacerbations     of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology     2-containing Inositol-5'-Phosphatase 1) pathway.   "
101725|NCT01954615|"     Study Part I is a single-ascending dose study. Healthy male subjects to be included in the     study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8 subjects     per group, 6 subjects receive the investigational drug and 2 subjects receive matching     placebo. Study Part II is a 3-period, crossover, single dose study. Nine healthy male     subjects to be enrolled in one group (Group G). Each subject to receive 2 different     formulations of the prodrug and one formulation of the active drug in a randomized sequence.   "
101726|NCT01954602|"     The specific goal of this study is to compare the deep biliary cannulation rate and     complication rates associated with use of touch and no touch guide-wire biliary cannulation     techniques.   "
101730|NCT01954550|"     This randomized controlled trial (RCT) will investigate the effects of a 6-month,     individualized, moderate-intensity cycling intervention on cognition and hippocampal volume     in AD with three aims:        -  Determine the immediate effect of the cycling intervention on cognition in AD.        -  Examine if the cycling intervention slows cognitive decline in AD from baseline to 12          months.        -  Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using          MRI.      The investigators will randomize 90 participants to the 6-month cycling or stretching/range     of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for     another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and     hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6,     and 12 months.   "
101731|NCT01954537|"     To collect field data in professional, collegiate, and high school football players to     determine how they respond physiologically to the rigors of preseason training environment.     Investigators will compare core temperature, hydration status, practice guidelines regarding     rest and hydration, and baseline knowledge of heat illness and hydration among the three     levels. The hypothesis is higher peak temperatures will be observed in the younger less     experienced football players.   "
101732|NCT01954524|"     Safety and tolerability of a single dose intravenous bolus injection of Sildenafil in     patients with moderate to severe cirrhosis and kidney disease will be determined.   "
101733|NCT01954511|"     The objective of this study was to investigate the effect of a manual therapy and exercise     program, focused on the rehabilitation of cervical function, on clinical signs and mandibular     function in subjects with TMD.   "
101734|NCT01954498|"     The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day     added to the diet of men seeking care for infertility will beneficially affect sperm     parameters and fertility. The investigators will compare the walnut intervention to the     commonly suggested recommendation of adding an OTC multivitamin supplement to the diet.   "
101735|NCT01954485|"     This study aims to demonstrate the histological differences in the connective tissue     surrounding laser-treated abutments and untreated abutments in humans.      Working hypothesis: There are differences in the adhesion of collagen fibres around implant     abutments with laser-produced microgrooves and standard abutments.   "
101746|NCT01954342|"     The purpose of this study is to measure energy intake and energy expenditure during and after     pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the     IOM guidelines, 'High Gainers', will have increased energy intake but no evidence for changes     in energy expenditure after adjustment for the weight gained when compared to women with     appropriate gestational weight gain, 'Normal Gainers'. Additionally, the investigators will     measure the babies born to the pregnant women enrolled in MomEE at one time point before 10     days of life.   "
101736|NCT01954472|"     Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial     (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce     cardiovascular events in middle-aged and older men and women at high risk of such events? To     address this question, we propose a pilot study of 3 years in duration: 1 year recruitment     and randomization, a full year of intervention for all recruited participants, and the last 6     months to assess the one year data and prepare and submit the full trial application,     informed by the pilot study outcomes in terms of retention rate. The pilot will then continue     on for the full 9 years of intervention and be rolled into the main study involving     additional Canadian centers and collaborating international centers in the US, Britain,     Europe, Australia, New Zealand, India, and South Africa.   "
101737|NCT01954459|"     This study will investigate the effect of wearing a small warming patch, the InsuPatch, at     the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will     be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose     monitor.   "
101738|NCT01954446|"     The primary purpose of this investigation is to validate the performance and safety of the     Investigational Device (ID) against a validated and legally cleared device for measuring     Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a     period of 24 hours against a validated and legally cleared device for Ambulatory Blood     Pressure Monitoring (ABPM).   "
101739|NCT01954433|"     This study compares costs and effectiveness / utility of three common orthopedic surgeries in     shoulder and hand from the perspective of the Swiss health system and the clinic.      The cost of health care is continuously rising, making economic considerations part of the     decision process, in particular for the allocation of available resources. However,     cost-effectiveness and cost-utility studies of interventions in the upper extremities are     rare. The purpose of this study is to gain more information and to provide a basis for the     decision process.   "
101740|NCT01954420|"     The purpose of the research is to test the efficacy of a patient-controlled     cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during cancer     treatment, and to evaluate moderators and mediators of intervention effects. The intervention     uses guided imagery, relaxation exercises, and nature sound recordings, self-administered via     an MP3 player. The study will determine (1) if the intervention helps to control symptoms     during chemotherapy, (2) if personal and clinical characteristics influence how well the     intervention works, and (3) if the cognitive-behavioral strategies reduce markers of stress     and inflammation found in blood and saliva.   "
101741|NCT01954407|"     The purpose of this study is to determine whether anti-smoking messages based on promising     smoking-related beliefs increase anti-smoking intentions more than messages based on     less-promising beliefs. Never smokers and former smokers will be randomly assigned to view     different anti-smoking messages, and will answer questions measuring smoking-related beliefs,     intentions, and message ratings online.   "
101742|NCT01954394|"     Primary Objective:      To assess the long-term safety of alirocumab when added to lipid-lowering therapy in patients     with heterozygous familial hypercholesterolemia (heFH).      Secondary Objectives:      To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the     long-term immunogenicity of alirocumab.   "
101766|NCT01954082|"     This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine     the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without     severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks     postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.   "
101866|NCT01952769|"     Diffuse pontine gliomas are incurable with currently used treatments. based on data stating     that progressive tumors inhibit immune system, would try to enhance immune system activity     and tumor cell killing. anti PD1 prevents one of the important mechanisms allowing the tumor     to supress the immune system thus we hope it will allow for prolonged control of the tumors   "
135631|NCT01509469|"     The purpose of this study is to determine whether ileal infusion of casein and sucrose can     activate the ileal brake.   "
101743|NCT01954381|"     Rheumatoid arthritis (RA) is one of the most common inflammatory diseases in the general     population and many cardiovascular diseases (valvular, myocardial, pericardial, coronary     disease, stroke, heart failure etc.) have already been described in this disease. Large     epidemiological studies have also demonstrated a higher degree of severity of atherosclerotic     vascular disease in RA patients, to such a degree that several authors have highlighted the     fact that, in the final analysis, the prognosis of RA is rather determined by the severity of     atherosclerotic lesions.      By reducing RA-related systemic inflammation, it can therefore be hypothesized that 24 weeks     of anti-TNF therapy would improve arterial endothelial function and large artery stiffness.      The proposed study will assess the effects of adalimumab therapy on these parameters. A group     of 26 RA patients will be recruited from a rheumatologists association of the French PACA     region (CONCERTO association). This study will be non invasive and will comprise:        -  in vivo study of endothelial function by measuring the post-ischaemic dilatation by 2D          ultrasound;        -  study of large artery stiffness by pulse wave velocity determined by aplannation          tonometry;        -  study of central pulse pressure;        -  evaluation of atherosclerosis-related parameters such as intima-media thickness.      The results obtained should provide a better understanding of the mechanisms involved in     RA-related vascular disease and the effects of anti-TNF therapy.      In view of the high prevalence of RA, this study could potentially interest the medical     community as a whole and could be largely diffused.   "
101744|NCT01954368|"     Non-invasive and simple, intranasal (IN) route of administration seems promising for pain     management in the Emergency Department (ED), especially when used precociously by triage     nurse to rapidly deliver the first opioid dose to severely painful patients.      This randomized double-blind placebo-controlled study will focus on severe traumatic pain     experienced by adults admitted in our ED.      We hypothesized that, in addition to traditional morphine titration, a single dose of IN     sufentanil given at triage would significantly increase the proportion of patients relieved     30 minutes after their ED admission.      Time to discharge, proportion of side effects and satisfaction rates will also be recorded.   "
101791|NCT01953744|"     The purpose of this study is to evaluate the therapeutic response to fluconazole in patients     with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.   "
101747|NCT01954329|"     MIND-TIA is primarily an observational diagnostic study that aims to evaluate the role of     novel biomarkers in the diagnosis of Transient Ischemic Attack (TIA)in primary care.      Rapid and adequate diagnosis of TIA is of great importance to enable a rapid start of     treatment, and thereby decrease the risk of subsequent ischemic stroke.   "
101748|NCT01954316|"     This is a phase 1 study to test different doses of a new investigational drug called     CFI-400945 to see which dose is safer in people. This study will also look at the safety of     CFI-400945 and to study its effects on patients with advanced cancers. This drug has been     tested in animals but not yet in people.      CFI-400945 is an oral (taken by mouth) drug that works by blocking polo-like kinase 4 (PLK4)     from working. PLK4 is a protein that is important in regulating cell growth and division and     cell death. Many tumors are shown to make too much PLK4. When there is too much PLK4     produced, it is believed to lead to uncontrolled cancer cell growth and division. Therefore,     by blocking this protein from working, it is believed to stop tumors growing or shrink them.   "
101749|NCT01954303|"     Coronary artery disease (CAD) is one of the leading causes of morbidity and mortality     worldwide. Life threatening manifestations such as acute myocardial infarction (AMI) and     sudden cardiac death are the most important causes of death in many countries. Cardiac     troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for     diagnosis of acute myocardial infarction by the Universal definition of myocardial     infarction. Since a new generation of high-sensitivity cardiac troponin assays has become     commercially available a few years ago, myocardial infarction can be detected earlier and     even small AMIs, that were classified as unstable angina pectoris (UAP) with the less     sensitive assays, are detectable now. On the other side, more patients with acute or chronic     myocardial damage not due to AMI are identified now. Thereby, the reason for elevated     troponin levels should be sought actively, because high troponin levels were associated with     adverse outcome - independent of the underlying pathomechanism. The reasons for troponin     elevations in patients with stable CAD are not clear yet. Associations with extensive     atherosclerosis, carotid lesions and complex coronary plaques in coronary CT scans were     reported. Therefore, patients with elevated troponin levels represent a risk population and     might profit from intensified secondary prevention. In this context, ticagrelor might be part     of a prevention strategy as currently tested in the PEGASUS trial.      We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of     our outpatient clinic, because data regarding prevalence, causes and prognosis of elevated     troponin values in unselected cohorts is sparse. Therefore, all patients (n=910) that     presented to our outpatient clinic 12 months after introduction of the high-sensitivity     troponin T assay (june 2009) and were free of complaints or presented with UAP are being     enrolled. All patients are characterized by demographic, laboratory and clinical     characteristics (including medication) and all available imaging data (exercise-ecg,     echocardiography, stress-echocardiography, computed tomography, cardiac MRI and coronary     angiography) in order to compare baseline characteristics of troponin positive and troponin     negative patients. In addition, the Framingham- and PROCAM-Score representing established     calculators of long-term risk prediction are calculated.      Prognostic endpoints are defined as severe cardiovascular events and progress of the     initially diagnosed disease. Those endpoints are associated with the initial hs-cTnT value     and serial changes.   "
101785|NCT01953822|"     This is an observational cohort study to assess the risk of autoimmune disease(s) within 12     months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable     period in the unexposed cohorts.      This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA     safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period     mid-September 2008 to 2011 to allow suitable data to be collected.   "
101832|NCT01953211|"     The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian     axis during the hormone-free interval in combined oral contraceptive (COC) hormone users     varies depending on the dose of ethinyl estradiol in the formulation. This variation in     activation may be associated with different side effects during the hormone free interval.     Progesterone (P) remained suppressed during all 6 COC regimens (<1.8 ng/mL), which indicates     continuous contraceptive efficacy during the 7-day hormone free interval of all formulations     studied.   "
101750|NCT01954290|"     Stroke remains the fourth leading cause of death in the United States (second worldwide) and     a leading cause of long-term disability, resulting in total direct and indirect costs of     approximately $73.7 billion annually. The failure of novel therapies in clinical trials     demonstrates that the complex neural response to stroke must be targeted at multiple levels     to improve patient outcomes. Despite significant improvements in stroke treatment and     management, 1 year survival rate among stroke patients aged 65 years or more is around 25%,     and 5- year survival rate amounts to approximately 50%. The highest chances of death are     within 30 days of stroke. Mortality increases due to worsening brain dysfunction, elevated     intracranial pressure (ICP), and other comorbid conditions.      Treatments aimed at reducing post-stroke cytotoxic edema may reduce the risk for development     of malignant stroke and mortality. Current treatments such as osmo-therapy and     hemicraniectomy have substantial limitations, and mortality remains high, despite these     measures outcomes remain unsatisfactory. There is a great need for alternative medical     approaches which are safe, predictable, and help to ameliorate post stroke edema.   "
101751|NCT01954277|"     The purpose of this study is to determine whether electroacupuncture is effective in the     treatment of chronic tension-type headache, measured by Headache Impact Test, Visual Analogue     Scale and biomarkers.   "
101752|NCT01954264|"     This study is designed to characterise P. falciparum transmission intensity in subjects aged     ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate     the use of malaria control interventions at some centres selected for the EPI-MAL-002 and     EPI-MAL-003 studies in sub-Saharan Western Africa.   "
101753|NCT01954251|"     The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK     Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine     in adults aged 50 years or older compared to administration of vaccines separately.   "
101754|NCT01954238|"     The purpose of this study is to evaluate the safety, tolerability and     Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.   "
101755|NCT01954225|"     The anal fistula is a notorious disease due to its recurrence rate. Bhagandara is varyingly     defined as a tear, ulcer or boil at Bhaga (Perianal region) within 2 finger circumference of     it, causing painful abscess when opened is called Bhagandara. The Sanskrit word 'Bhagandara'     has got two components-Bhaga and Darana. Bhaga means perianal region and Darana means to     tear. The ancient Surgeon Sushruta has advocated various types of operations in Sushruta     Samhita. He has advocated Kshara Sutra treatment due to probability of recurrence after     surgery. Sushruta describes many kind of kshara like Palasa, Kadali. The most remarkable is     Udumbara( Ficus Glomerata) among them. The present treatment modality Udumbara Kshara Sutra     has been found effective due to its action of proper drainage of pus from the fistula that     leads to a proper healing and as adjuvant therapy by avoid recurrence in Fistula in ano.      Hypothesis; Present treatment modality Udumber Sutra will found to be useful in tne     management of Fistula in ano.   "
101756|NCT01954212|"     Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the     risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged     hospital stays and dependency at discharge. Systematic review evidence indicates that     enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia     amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to     treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar     benefits might be observed in stroke care settings but current empirical evidence is weak -     trial quality (randomisation, blinding, sample size, reporting), intervention description and     thus feasibility of translation into clinical practice is very poor. Following an extensive     pre-clinical programme of work, investigators now plan the pilot phase (Phase II) of a     stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention versus     usual OHC. Investigators aim to establish a robust web-based randomisation process, refine     the proposed intervention (training, tools, equipment), recruitment, adherence, record     linkage and sampling methodologies. Investigators also aim to establish the relationship     between SAP and plaque and any diversity between sites.   "
101757|NCT01954199|"     This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic     treatment over two weeks.   "
101758|NCT01954186|"     To compare the efficacy of the route and timing of oxytocin administration for Active     management of third stage of labour (AMTSL).   "
101759|NCT01954173|"     This phase II trial studies how well modern, conformal radiation therapy after surgery works     in treating patients with high-risk bladder cancer. Specialized radiation therapy that     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause     less damage to normal tissue.   "
101760|NCT01954160|"     Congestive heart failure is a common disorder in which the heart cannot pump enough blood to     meet the needs of the rest of the body. Poor sodium handling by the kidneys is a damaging     effect of heart failure, and it leads to symptoms of congestion such as shortness of breath     or ankle swelling. Recent studies suggest that reducing the nerve activity to a kidney could     reduce sodium retention and blood pressure. An improvement in the way the kidneys handle     sodium may reduce disease progression and decrease symptoms for heart failure patients.   "
101761|NCT01954147|"     Umbilical cord mesenchymal stem cells (SC) transplantation was a novel therapy for diabetes     mellitus, with less side effects and more advantages. Clinical trials had verified that good     metabolic control would be achieved when Liraglutide (GLP-1) was added to the conventional     therapies. The investigators hypothesized that the combined therapy of umbilical cord     mesenchymal stem cells transplantation and Liraglutide in type 2 diabetes mellitus will aid     the differentiation of stem cells into insulin-producing cells, improve the survival of     differentiated cells, protect the residual beta-cells and improve insulin secreting function,     so as to achieve a favorable glucose homeostasis.   "
101762|NCT01954134|"     In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is     considered as radioiodine resistant or in another words in the process of dedifferentiation.     The aim of the present study was to search a simple blood test that could lead to early     identification of patients with dedifferentiation. In this respect, we investigate whether     the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients     with high levels of thyroglobulin (tg) and negative I-131 scan.   "
101767|NCT01954069|"     The study seeks to test whether it is feasible and acceptable for both women and providers     (in this context the Lady Health Visitor) to use the semi-quantitative pregnancy test (SQPT)     as a tool for follow up after MR services. The study is planned at 11service delivery points     (primary health clinics) in Punjab province where consenting women will be asked to take a     baseline test at the clinic the morning they present for the MR procedure. Women will be     asked to complete a second test at home the morning of their scheduled follow up visit and     return to the clinic for follow-up care later that day. The results of the at home test will     be compared to the baseline to determine the outcome of the MR. This is of particular     importance because to-date no research has documented the accuracy of the test in detecting     MR outcomes with misoprostol only regimens.      We hypothesize that women and providers will find the test easy and acceptable to use thereby     improving follow up and simplifying MR service provision. In addition, the simple pictorial     instructions will enable most women to use the test and interpret the results correctly on     their own.   "
101768|NCT01954056|"     This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on     short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in     critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as     defined by a need for inotrope therapy in the first 72 hours of age.   "
101769|NCT01954043|"     The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and     rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate). The     study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data collected     from this study will be used to inform recommendations regarding use of concomitant     medications with dabrafenib and future clinical pharmacologic evaluation of dabrafenib.   "
101770|NCT01954030|"     The primary objectives of the study are to determine the maximum tolerated dose (MTD) of     Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among     patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed     bevacizumab (Phase 1); to determine the activity of CTO alone in bevacizumab-failure WHO     grade IV malignant glioma patients (Phase 2, Arm 1); to determine the activity of CTO plus     bevacizumab in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 2).      This study was terminated early due to funding issues. At the time of termination, the study     was still in Phase 1 and no MTD for the combination of CTO and bevacizumab had been     determined for this population. Phase 2 will not proceed.   "
101771|NCT01954017|"     The study will be conducted in two parts. Part A will be a sequential dose escalation study     to determine the safety and tolerability of two doses of STP206 versus control. Part B will     evaluate safety and NEC preventive efficacy of STP206 in VLBW and ELBW neonates.   "
101772|NCT01954004|"     This registry is intended to evaluate the impact of genomic test results towards selecting a     first-line therapy option for newly diagnosed localized prostate cancer patients.   "
101773|NCT01953991|"     Removable false teeth (called removable partial dentures (RPDs)) are commonly made for people     with missing teeth.      RPDs are made out of a framework and the replacement teeth/gum. The framework sits on the     teeth and the gums and can be made out of different materials, metal or non-metal, with     different properties. The plastic teeth and gum sit on the framework.      A common framework material is cobalt chromium, a rigid, non-precious metal alloy. Other     framework materials include titanium and non-metal materials such as medical grade     polyetheretherketone (PEEK).      A review of the literature shows that no research has been reported investigating how     different RPD framework materials impact on a person's oral health related quality of life     (OHQoL). The sensation that different frameworks have in the mouth can be quite varied     between people, and it would be relevant to be able to tell patients which type of framework     is better tolerated based on research evidence.      We hope to conduct an un-blinded randomised crossover pilot trial investigating the     difference in patient preference and oral health related quality of life measured by patient     centred outcomes in a group of patients due to receive tooth supported removable partial     dentures at the Charles Clifford Dental Hospital.   "
101774|NCT01953978|"     The analgesic effect of dexamethasone is not well described, but studies have shown that     dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our     purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has     an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative     pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain     and reduce opioidconsumption and side effects compared to placebo.   "
101775|NCT01953952|"     This randomized phase II trial studies radiation therapy and cisplatin with or without     surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses     high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor     cells. It is not yet known whether radiation therapy and cisplatin are more effective with or     without surgery in treating patients with oropharyngeal cancer.   "
101786|NCT01953809|"     This study is being conducted to confirm that GSK1322322 has no negative impact on hormone     levels and contraceptive efficacy when co-administered with a frequently prescribed oral     contraceptive thereby to facilitate the use of GSK1322322 in women of child-bearing potential     receiving oral contraceptive (OC) pre-infection. This study is designed to investigate     steady-state plasma ethinyl estradiol (EE) and norethindrone (NE) pharmacokinetic (PK)     following administration of Ortho-Novum (EE/NE) 1 tablet every 24 hours (q24h) fed with and     without GSK1322322 1500 milligram (mg) q12h fed. Each subject will participate in the study     for approximately 12 weeks: a 30 day screening period, 4-week run-in period, three 7 day     treatment periods, and a 3-5 day follow-up period. The study is planned to enroll     approximately 24 subjects (18 active/6 placebo).   "
101787|NCT01953796|"     The objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol     to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional     protocol.      Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder     teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the     inclusion criteria, they were divided into two groups; 65 patients for the stair step     protocol and 75 patients for the traditional protocol.   "
101776|NCT01953939|"     During any period of rehabilitation it is important to select meaningful tests that; measure     what you want, are responsive to changes in the patient's condition and, easy to use in the     clinical settings. With an amputee such tests may help make sure that rehabilitation     programmes and the prosthesis (artificial leg) provided are tailored for the individual. New     prosthetic technology is continually being developed and the active amputee now demands more     from their artificial limbs. Making sure that they get the right rehabilitation programmes     and the most appropriate prosthesis will help them perform to their best.      Twenty lower limb amputees who have had their artificial limb for at least one year will be     recruited into this study. They will be asked to complete 2 walking tests and 4     questionnaires that measure different aspects of their condition from the comfort of the     socket to their perceived ability to undertake everyday tasks. Each of the tests give a score     or grade which represents the level of their ability, as judged by the test, at that given     time point. The tests will be repeated on a second occasion between seven to ten days after     the first.      By measuring the changes in the scores on these two occasions it is hoped that indices of     reliability can be established for these particular tests that have been shown to be most     widely used by Health Professional involved in the rehabilitation of amputees across the UK.     It is also hoped that the minimal detectable change (MDC) can also be calculated for these     tests. By understanding the MDC for a test then anyone using it will be able to know whether     any changes in scores detected are real changes due to changes in the patient's abilities or     just down to chance.   "
101777|NCT01953926|"     This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and     safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR     mutations or with EGFR gene amplification.   "
101778|NCT01953913|"     Primary objective of the trial is to evaluate the safety of afatinib in patients with locally     advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth     factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase     inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged     by investigator).   "
101792|NCT01953731|"     This study will compare the plasma pharmacokinetics of a single 125mg oral dose of     palbociclib in the presence and absence of rifampin-mediated enzyme induction in a     fixed-sequence two-period study.   "
101793|NCT01953718|"     The purpose of this study is to assess the impact of different parameters (voltage, pulse     width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms     in patients with Parkinson's disease (PD).   "
101886|NCT01952509|"     This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra     (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid     arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the     local label will be followed for 6 months.   "
101779|NCT01953900|"     PLEASE NOTE - THIS STUDY IS CURRENTLY ONLY RECRUITING PARTICIPANTS WITH OSTEOSARCOMA.      The purpose of this study is to find the largest safe dose of GD2-T cells (also called     iC9-GD2-CAR-VZV-CTLs), and additionally to evaluate if a VZV vaccine can improve the     expansion and persistence of infused T cells, to learn what the side effects are, and to see     whether this therapy might help patients with advanced sarcomas. Because there is no standard     treatment for recurrent/refractory sarcomas at this time or because the currently used     treatments do not work fully in all cases, patients are being asked to volunteer to take part     in a gene transfer research study using special immune cells.      The body has different ways of fighting infection and disease. No single way seems perfect     for fighting cancers. This research study combines two different ways of fighting cancer:     antibodies and T cells. Antibodies are types of proteins that protect the body from     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special     infection-fighting blood cells that can kill other cells, including cells infected with     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with     cancers. They have shown promise, but have not been strong enough to cure most patients.      Investigators have found from previous research that a new gene can be put into T cells that     will make them recognize cancer cells and kill them. Investigators now want to see if a new     gene can be put in these cells that will let the T cells recognize and kill sarcoma cells.     The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called     14g2a that recognizes GD2, a protein that is found on sarcoma cells (GD2-CAR). In addition,     it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live     longer.      Investigators have found that CAR-T cells can kill some of the tumor, but they don't last     very long in the body and so the tumor eventually comes back. T cells that recognize the     virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for     many years especially if they are stimulated or boosted by the VZV vaccine. Investigators     will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are     called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.   "
101780|NCT01953887|"     A study to assess the amount of drug in the blood of young to middle aged, healthy, male     subjects after they received the final formulation of EC905 compared to solifenacin     (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).      Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS®     in 3 separate periods.   "
101781|NCT01953874|"     The aim of the study is to compare the effects of MV targeted ASV in addition to optimized     medical therapy versus optimized medical therapy alone at 6 months in patients with acute     decompensated HF. The study will also assess changes in functional parameters, biomarkers,     quality of life (QOL), and sleep.   "
101782|NCT01953861|"     To evaluate the effect of food (low and high fat breakfast vs. fasting) on the     pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and     tamsulosin administered as combination tablet EC905. Also to evaluate the safety and     tolerability of single doses of EC905 in young, healthy male subjects, when administered     under fed (low and high fat) or fasting conditions.   "
101783|NCT01953848|"     Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints     related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the     treatment of patients suffering from problems related to overactive bladder, such as needing     to go to the toilet frequently and often having a sudden urgent need to go to the toilet.     Certain patients with an enlarged prostate have complaints that may benefit from a     combination of tamsulosin and solifenacin. EC905 is a single tablet containing both     tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and     solifenacin are taken up from the intestine, distributed through the body and eventually     eliminated from the body when taken as a single EC905 tablet.   "
101784|NCT01953835|"     This study is a Phase I, two-part, open-label study designed to evaluate the effect of     repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in     healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet     formulation of GSK2586184 in healthy male volunteers (Cohort B). Cohort A is a single     sequence drug interaction study in which 28 subjects (14 female and 14 male subjects) will be     enrolled. Each subject will receive single doses of Simvastatin and Rosuvastatin on two     occasions, once alone and once following administration of repeated doses of GSK2586184.     Cohort B is a 3-way crossover PK study in which 9 male subjects will be randomized (3     subjects to each treatment sequence). Each subject will receive a single dose of the standard     formulation of GSK2586184 with food and two doses of a new formulation of GSK2586184, once     with food and once in a fasted state, according to their treatment sequence, with a 3-day     wash out between doses. The primary aim of the study is to investigate the effects of     GSK2586184 on the pharmacokinetics of the 2 statins and to assess the impact of dosing with     and without food on a new formulation of GSK2586184 tablet.   "
101788|NCT01953783|"     This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable patients with     advanced solid tumors or lymphoma.   "
101789|NCT01953770|"     QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY        1. Whether the early PEG-asparaginase in induction will lead to the earlier achievement of          remission, improvement of days 8 and 15 responses leading to an earlier reconstitution          of bone marrow and immunocompetence, decrease of severe infections and early mortality          rate?        2. Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines          in standard risk group patients and to reduce treatment myelotoxicity?        3. Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18 doses          of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve treatment          outcome?        4. Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st          consolidation in intermediate risk patients will result in decrease of central nervous          system relapse incidence and improvement of event-free and overall survival? Whether the          increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation phase          (instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied with          enhanced toxicity?        5. Is it possible to completely avoid the cranial irradiation in intermediate risk          patients? In some subgroup of intermediate risk patients? Is it enough to control          neuroleukemia in these patients to introduce additional TIT in the consolidation phase          of treatment? How will change the possible late effects in these patients according to          the third arm of randomization?        6. Will the new risk group stratification to improve overall and event-free survival?   "
101790|NCT01953757|"     The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a     low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and     other subjective symptoms, more effectively than a vitamin B12 supplement with no diet     changes. The principal measure is pain as measured by the following assessment tools:     Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy     Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill     Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks.      This study also examines the effects of a low-fat, vegan diet on mood, using the Center for     Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.   "
101794|NCT01953705|"     Brain scans can help identify changes that appear to increase risk for cognitive decline and     dementia. Some of these brain changes are thought to reflect actual damage to the small blood     vessels that support normal brain function. This clinical trial will determine whether an     omega 3 polyunsaturated fatty acid (PUFA) therapy can promote brain health by supporting the     small blood vessels in the brain over 3 years in older adults at high risk for cognitive     decline and dementia of Alzheimer's type.   "
101795|NCT01953692|"     The purpose of this trial is to evaluate the safety, tolerability, and efficacy of     pembrolizumab (MK-3475, KEYTRUDA®) in hematologic malignancies. The primary study hypotheses     are that treatment with pembrolizumab will result in a clinically meaningful improvement in     Objective Response Rate (ORR) or Complete Remission Rate (CRR).   "
101796|NCT01953679|"     To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate     5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.   "
101797|NCT01953666|"     Computers now play an important role in the lives of most individuals.Access to computers is     crucial for people with disabilities and may improve their quality of life. The use of     computers can facilitate mainstreaming at school, for example, and the Internet may provide a     valuable means of communication. However, the use of computers requires a certain degree of     motor ability. People with motor disabilities frequently experience difficulties using a     standard keyboard and standard pointing input systems such as a mouse. Many solutions exist     to facilitate computer access, depending on the person's specific impairments and the purpose     for which the computer is used. The most common solution relies on the use of a virtual     keyboard which is directly displayed on the computer screen. The selection of the desired key     on the virtual keyboard can be handled by a large variety of input devices, from a     microgravity mouse to single switch devices supplemented by a process of dynamic scanning of     the keyboard.Although such assistive devices render computers accessible to people with     disabilities, the actual inputting of text can be very slow. A method to increase text input     speed is to display words which are predicted from the letters previously typed. Word     prediction reduces the number of necessary key strokes by avoiding having to type the whole     word. The effect on text input speed is, however uncertain and results in the literature are     inconclusive. Indeed, word prediction software provide a enhancement of cognitive load which     decrease text input speed.The reduction of cognitive load could therefore be based in part on     the optimization settings of the software and / or achievement of a rehabilitation     program.Our hypothesis are for people with spinal cord injury : i) optimization settings word     prediction software and ii) a rehabilitation program could improve the text input speed.The     investigators propose to study the influence of settings word prediction software on text     input speed and the influence of a rehabilitation program provided by a therapist, focused on     word prediction software to help integrate them. The aim is to increase the performance of     people with spinal cord injury and their satisfaction.      The first phase of this research is to select the word prediction software and configuration     that provides the best user support.The second phase corresponds to the objective of     evaluating the efficiency of a rehabilitation program .   "
101798|NCT01953653|"     This protocol explores the feasibility and acceptability of using two daily diary methods to     analyze state-dependent variables and psychosocial health outcomes in Human Immunodeficiency     Virus (HIV)-positive young men who have sex with men (YMSM). The study will explore the     potential of diaries for use in feedback-based interventions.   "
101799|NCT01953640|"     This research trial studies gene expression in patients with prostate cancer that has spread     to other places in the body receiving cytochrome P450 17 alpha hydroxylase/17,20 lyase     (CYP-17) inhibition therapy. Studying samples of tissue, blood, and urine in the laboratory     from patients receiving CYP-17 inhibition therapy may help doctors learn more about changes     that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may     also help doctors understand how well patients respond to treatment.   "
101829|NCT01953250|"     Questionnaire To assess the functional outcome in patients that underwent laparoscopic     sigmoid and/or rectum resection.   "
101830|NCT01953237|"     We propose to develop and pilot test the effect of a mobile smartphone intervention,     MedActive, on improving antipsychotic adherence among individuals with schizophrenia.   "
101831|NCT01953224|"     The purpose of the study is to test an intervention that uses a mobile game to encourage     increased physical activity among adults.   "
101800|NCT01953627|"     Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is     limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.      Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic     procedures in gynecology.      Material and methods : Observational study. Inclusion criteria were : patient requiring     laparoscopic procedure in gynecology who give informed consent. The investigators evaluate     procedures routinely performed by laparoscopy in gynecology.      Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.   "
101801|NCT01953614|"     Despite the abundance of theories concerning the effects of chiropractic adjustments on brain     function, this remains an understudies area for the profession.      Quantitative Electroencephalography (qEEG)is a technique that allows for an in-depth analysis     of brain function. A normative database will be used to compare before, during and after     effects of chiropractic adjustments on brain function. This will include usage of Low     Resolution Electromagnetic Tomography (LORETA).      This study seeks to objectively document effects of chiropractic adjustments on brain     function.   "
101802|NCT01953601|"     This study consists of two parts, Part I and Part II. The purpose of Part I of the study is     to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo     administered for 104 weeks in the treatment of amnestic mild cognitive impairment (aMCI) due     to Alzheimer's Disease (AD), also known as prodromal AD. Participants will be randomized to     receive placebo, or 12 mg or 40 mg verubecestat, once daily. The primary study hypothesis for     Part I is that at least one verubecestat dose is superior to placebo with respect to the     change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at 104     weeks. Participants who complete Part I of the study may choose to participate in Part II,     which is a long term double-blind extension to assess efficacy and safety of verubecestat     administered for up to an additional 260 weeks. In Part II, all participants will receive     either 12 mg or 40 mg verubecestat, once daily.   "
101803|NCT01953588|"     The study is being conducted to determine whether neoadjuvant endocrine therapy with     fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole     when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits     tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug     Administration (FDA) of the United States for use after surgery for postmenopausal women with     estrogen receptor positive breast cancer. It is also considered a standard of care to give     anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor     cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved     by the FDA for use in women with early stage breast cancer before or after surgery, but is     approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast     cancer that has spread to other parts of the body.   "
101805|NCT01953562|"     The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the     NICU who are potential candidates for extubation from mechanical ventilatory support. For all     parents who consent, the routine SBT will be performed on all infants. In addition to the     routine SBT the following will occur:        1. work of breathing indices: obtained non-invasively through respiratory inductive          plethysmography (RIP).        2. Performing the SBT in the prone position, in addition to the routine position (supine).   "
101806|NCT01953549|"     The aim of this study is to investigate whether a 4-week physical fitness training (target     intervention) in stroke patients (subacute stage) increase the walking speed and activities     of daily living compared with a control intervention (relaxation exercises). The target or     control intervention is performed in addition to standard rehabilitation treatment.   "
101807|NCT01953536|"     The purpose of this study is to assess the efficacy and safety of vintafolide alone compared     to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive     folate receptor (FR) triple negative breast cancer (TNBC).      The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel     will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to     paclitaxel alone.   "
101808|NCT01953523|"     To evaluate for any adverse effects that may be related to the administration and reception     of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study     monitors the results of subjective and objective findings as it applies to the non-blinded     deployment of autologous SVF for various inflammatory and/or degenerative conditions     including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF     deployments include intra-venous, intra-articular, and soft tissue injections.   "
101809|NCT01953510|"     Pneumococcus is a group of bacteria that can cause pneumonia, meningitis and other diseases.     These bacteria normally live in the nose of humans and are spread from person to person by     touching or sneezing. There are vaccines available to protect against infection with these     bacteria, and pneumococcus is currently the leading vaccine-preventable cause of death in     young children. In countries where pneumococcal vaccine (PCV) has been introduced, there has     been a big impact on the amount of disease caused by these bacteria. However, many countries,     especially developing countries, are yet to introduce PCV as part of their routine     immunizations. Currently a total of four doses of PCV is recommended, and the main barrier to     vaccine introduction is cost. This study aims to identify a vaccination schedule to make PCV     more effective and affordable for Vietnam and other developing countries.      This study has two distinct purposes: 1) to compare different dosage schedules of PCV and 2)     to compare different PCV vaccines.        1. Schedules of Synflorix (PCV10) involving a three, two or one dose PCV primary series and          two booster options will be compared. Comparisons will be made firstly in terms of          measures of immunity to the vaccine, and secondly in terms of the effect of vaccination          on the carriage of bacteria in the nose.        2. The responses to PCV10 and Prevenar-13 (PCV13) will be compared, in the schedule most          likely to be considered for global use. Again, comparisons will be made in terms of          measures of immunity and effect on carriage in the nose.      Infants aged two months will be randomly assigned to one of six study groups and will provide     up to four blood samples for analysis of the measures of immunity and five nose swabs for     analysis of carriage of bacteria. Infants will be followed up 8-9 times until the age of 24     months. An additional control group will be recruited at 18 months of age and also followed     up until 24 months of age.      The results of this study will be used to facilitate decision making, at global and national     levels, regarding introduction of PCV.   "
101810|NCT01953497|"     To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the     food effect on PK.   "
101854|NCT01952925|"     The purpose of this study is to perform renal artery denervation at the same time as atrial     fibrillation ablation. RA denervation may reduce blood pressure, increase the chances of a     successful atrial fibrillation ablation, and decrease the number of medications required to     control blood pressure.   "
101811|NCT01953484|"     In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide     (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to     hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency,     extracorporeal carbon dioxide removal may be used to control spontaneous ventilation,     limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little is     known about how spontaneous ventilation changes in response to changes in extracorporeal     carbon dioxide removal during acute respiratory insufficiency, especially in humans.      Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated     with extracorporeal gas exchange support because of acute respiratory insufficiency, in     response to changes in extracorporeal carbon dioxide removal.   "
101812|NCT01953471|"     Prospective multi-center study carried out in France involving patients with allergic     rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is     required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.   "
101813|NCT01953458|"     -  The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers          and behavioral data in a large number of patients and will be a leading equipment for          crossdisciplinary and translational research on hepatitis.        -  The cohort will be the main support for estimating the relative effects of treatments          and for further cost-effectiveness studies on the management and treatment options in          chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.   "
101814|NCT01953445|"     This phase II trial studies the effects of paclitaxel combined with phosphoinositide 3-kinase     (PI3K) inhibitor BKM120 in patients with stage II or III breast cancer that is described as     estrogen receptor-positive, human epidermal growth factor 2 (HER2)-negative and endocrine     therapy resistant. Drugs such as paclitaxel stop the growth of tumors by blocking cancer cell     division. PI3K inhibitor BKM120 inhibits some of the enzymes needed for cell growth and may     improve the response of endocrine resistant tumors to treatment. Giving paclitaxel and PI3K     inhibitor BKM120 before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.   "
101815|NCT01953432|"     Cocaine use disorders affect approximately 1.5 million Americans annually. Currently, there     are no US Food and Drug Administration approved medications for treatment of cocaine     dependence; however, both animal and human studies suggest that medications affecting the     noradrenergic system can reduce cocaine craving and use. The investigators will study the     effect of doxazosin, an alpha-1 adrenergic antagonist, in reducing cocaine use and anxiety     symptoms among cocaine-dependent individuals. In addition, the investigators will identify     genetic subpopulations of participants who preferentially respond to the medication.   "
101816|NCT01953419|"     This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with     pretreated metastatic gastric cancer.   "
101817|NCT01953406|"     The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the     patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease     with sorafenib.   "
101818|NCT01953393|"     Type 2 diabetes is characterized by increased insulin resistance and impaired insulin     secretion. In addition, type 2 diabetes is associated with low grade inflammation indicated     by increased levels of proinflammatory cytokines such as TNF-α. TNF-α has previously been     shown to impair peripheral insulin signaling in vitro and in vivo. However, it is unclear     whether TNF-α may also affect endogenous glucose production (EGP) during fasting and glucose     stimulated insulin secretion (GSIS) in vivo.      We hypothesized that low dose TNF-α would increase EGP and attenuate GSIS. Recombinant human     TNF-α or placebo was infused in healthy, non-obese and non-diabetic young men (n=10) during a     4-hour basal period followed by an intravenous glucose tolerance test (IVGTT).   "
101819|NCT01953380|"     The purpose of this study is to determine whether extended information given to patients with     contact allergy improves knowledge, treatment efficacy and daily functioning.   "
101820|NCT01953367|"     This study will investigate the bioequivalence and compare the safety profiles following     inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.      Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra     nebulizer solution compared to TOBI nebulizer solution.   "
101821|NCT01953354|"     The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova     (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response     and if there are related changes in participants' UC.   "
101822|NCT01953341|"     The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated     in healthy subjects and subjects with migraines. As part of the secondary objectives, this     study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize     the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after     single oral doses in healthy subjects and subjects with migraines   "
101823|NCT01953328|"     The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous     evolocumab administered every 2 weeks and once a month, compared with placebo, on percent     change from baseline in LDL-C when used in combination with statin therapy in adults with     high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.   "
101824|NCT01953315|"     This study is designed to evaluate the safety of muscle progenitor cells (MPCs) for the     treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).   "
101825|NCT01953302|"     Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate     efficacy of modified technique of ventral hernias repair: an open intraperitoneal mesh     technique.   "
101826|NCT01953289|"     The purpose of this study is to evaluate the frequency of positive free fluid cultures in     both perforated and non-perforated appendicitis. In addition predictors of positive free     fluid cultures will be analyzed.   "
101827|NCT01953276|"     Our research will examine whether the presence or absence of serial electrocardiogram (ECG)     changes aids in reclassifying participants' risk for major adverse cardiac events (MACE) over     and above serial blood testing.   "
101828|NCT01953263|"     This study is designed to evaluate the safety of autologous muscle fiber fragments for the     treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).   "
101833|NCT01953198|"     The aim of the project High Altitude Medical Research Expedition Himlung 2013 (HiReach2013)     is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and     the reactions of the human immune system during an ascent to extreme altitudes of over 7000     m. A total of 44 healthy and trained volunteers will be included in the study after written     informed consent has been obtained.Baseline sea level clinical examination will be performed     in Bern, Switzerland (BE1) at 550 m 8 to 4 weeks before departure. High altitude research     facilities will be available at the altitudes of 5000m, 6100m and 6900m. Post-expedition     examination will be performed within 2 to 6 weeks after the end of the expedition in Bern. In     the context of 3 sub-projects specific measurements and examinations are performed.      These include: cMRI before and after the climb and neurovascular doppler examination during     the climb; blood sampling for coagulation studies, cardiac and thoracic ultrasound, stress     tests for assessment of cardiovascular performance.   "
101834|NCT01953185|"     Question: Does manual diaphragm release change kinematics and respiratory function of elderly     subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control     Group (CG) and 08 in the Intervention Group (IG).      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten     deep breaths, with a one minute interval between them. The CG underwent a sham protocol     (light touch), with same sets and time of interval.      Outcome measures: The groups were evaluated using spirometry, manovacuometry and     optoelectronic plethysmography (OEP), in that order, before and immediately after the     intervention.   "
101835|NCT01953172|"     The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health     status and quality of life measures, cognitive functioning, oxidative stress, inflammation     markers and other symptoms effects on skin, sleep and vision in the elderly.   "
101836|NCT01953159|"     The purpose of this study is to collect clinical data, blood samples, and self reported     symptoms from patients that experience unusually severe neuropathy after treatment with     paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood     samples will be used to create induced pluripotent stem (iPS) cells and eventually artificial     nerve cells to be used to study neuropathy in the lab.   "
101837|NCT01953146|"     Polycystic ovary syndrome is one of the most common causes of female infertility. The cause     of infertility in PCOS is unknown. Factors other than anovulation, including inherited or     induced changes in the embryo quality have been suggested. Time-lapse analysis of embryo     development is a sensitive method of detecting reduced embryo viability. Yet, there are no     data regarding the embryo development in PCOS assessed by time-lapse analysis.   "
101838|NCT01953133|"     The prevalence for human immunodeficiency virus (HIV) in South Africa is 18% among 15-49 year     old adults and 30% among female antenatal clinic attendees (UNAIDS, 2007), indicating     continuing need for effective HIV prevention. Further, recent studies in sub-Saharan Africa     found 60-94% of new HIV infections are occurring within marriage or co-habiting heterosexual     partnerships (Dunkle et al., 2008). These findings signal the need for HIV prevention     interventions that target couples in South Africa. This study is a randomized controlled     trial of a behavioral intervention to increase HIV testing among couples living in     Vulindlela, South Africa.      The proposed intervention consists of six sessions (one mixed gender group, one single gender     group, and four couples' counseling sessions). Using a randomized controlled trial (RCT)     design with 350 heterosexual couples, we will test the hypothesis that compared with a     one-time mixed-gender group session, the proposed intervention will improve communication,     intimacy and trust necessary for mutual decision-making about behaviours related to sexual     risk behaviour and testing for HIV. Improving couples' ability and motivation to participate     in Couples HIV Testing and Counseling (CHTC) for HIV will in turn lead to reductions in     sexual risk behaviour. Both of these outcomes are necessary and effective strategies to     reduce the risk of HIV transmission within primary partnerships.      This intervention is informed by several qualitative studies conducted in Vulindlela and     Soweto, South Africa via a K08 award from NIH, as well as other funding sources. These     preliminary studies provided insight into the challenges couples face in participating in     CHCT, as well as the skills they need in order to address these barriers. Our experience     conducting both qualitative and quantitative studies with comparable populations (i.e. South     African couples) has also informed the recruitment and retention methods in this     intervention. The proposed study takes advantage of the infrastructure and collaborative     relationships that the PI has developed that have enabled her to implement and conduct     research within these communities.      The specific aims of the project are to test the efficacy of a theory-based and culturally     appropriate couples-based intervention on the following outcomes:        1. Rates of testing for HIV,        2. Sexual risk behaviour for HIV (with primary and any concurrent partners).      In addition we will evaluate the extent to which hypothesized mediating factors (e.g.,     relationship dynamics) explain the major outcomes and the extent to which the intervention     affects these factors.      Ultimately, our goal is to facilitate the outcome that members of partnerships learn their     own and their partner's HIV status. This is a crucial step for effective behavioural risk     reduction, yet it is a relatively uncommon occurrence for partners in Vulindlela, South     Africa. Specifically, mutual disclosure of HIV status accomplishes two important goals.      First, this knowledge can facilitate risk-reduction behaviour within partnerships via     effecting positive changes (e.g., condom use) in sexual behaviour with primary and any     concurrent partners. Second, knowledge of HIV status can increase access to treatment and     care for HIV-positive individuals, as well as reinforce behavioural choices (e.g., limiting     concurrent partners) to stay HIV-negative. As couples are particularly vulnerable for HIV     infection in this context, increasing testing for HIV and reducing likelihood of behavioural     transmission of HIV within partnerships would be a high-impact outcome with the potential to     significantly reduce the impact of HIV in an area already severely affected by the pandemic.   "
101887|NCT01952496|"     The goal of this project is to design and validate a force-measuring platform that will     measure the magnitude and duration of the load experienced by the lower extremities of     individuals with a neuromuscular disability who use a stationary assisted standing device to     increase their Bone Mineral Density.   "
105714|NCT01902342|"     Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy     Korean volunteers.   "
101839|NCT01953120|"     This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the     prevention of acute rejection and preservation of kidney function in transplant patients.     Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and     is being marketed as Nulojix. The pharmaceutical company sponsoring this study is     Bristol-Myers Squibb.      Belatacept is a prescription medicine used in adults to prevent transplant rejection in     people who have received a kidney transplant. Transplant rejection happens when the body's     immune system senses that the new transplanted kidney is different or foreign, and attacks     it. Belatacept is used with corticosteroids and certain other medicines to help prevent     rejection of your new kidney.      The purpose of the research is to understand whether the new drug, belatacept, is better than     other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used in     the treatment against kidney rejection in transplant patients.   "
101840|NCT01953107|"     The prevalence of anemia in gynecologic oncology new patients has been seen in previous     studies to be as high as 35-59%. this population includes women with several types of     gynecologic malignancies. Therefore, it is assumed that the origin of the anemia can be due     to anemia of chronic disease and iron deficiency anemia. No previous studies have looked at     the efficacy of oral iron supplementation with concurrent Vitamin C in women with newly     diagnosed gynecologic malignancies.      Hypothesis: In newly diagnosed gynecologic oncology patients who are surgical candidates does     treatment with 3-6 weeks of oral ferrous fumarate 300 mg once a day improve the mean change     in hemoglobin levels, from baseline to pre-operative, in comparison to placebo.   "
101841|NCT01953094|"     The purpose of this study is to determine the possibility and compliance of performing anal     Pap smear and Human Papilloma Virus (HPV) DNA testing on women with high grade lower genital     tract dysplasia or cervical cancer and determining the prevalence of anal dysplasia in this     population using a high-resolution anoscopy (HRA). In addition, it is being done to     potentially develop screening, diagnostic and treatment protocol for anal dysplasia in women     with high-grade lower genital tract dysplasia or cervical cancer.   "
101842|NCT01953081|"     This study is being conducted to evaluate the safety, tolerability and early efficacy of IV     TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are     admitted to the intensive care require mechanical ventilation, and are intolerant to enteral     feeding.   "
101843|NCT01953068|"     Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of     post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive     functions are located, are highly susceptible to trauma caused by possible blood malperfusion     to these areas of the brain during surgery. Conventional and established neuropsychological     test methods are poor in distinguishing these kinds of trauma, as they are isolated,     structured tests that do not require multitasking and processing of multiple stimuli at the     same time.      The phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test     to see if this method could improve objective detection of subtle brain dysfunction assumed     to underlie persistent cognitive, somatic, and affective complaints reported by patients who     have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will     concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).   "
101865|NCT01952782|"     The investigators are seeking healthy volunteers and volunteers with reproductive disorders     for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally     occurring opioid hormone that is blocked by naloxone.      We hypothesize that naloxone, by blocking dynorphin, will stimulate production of GnRH and     kisspeptin, 2 other naturally occurring reproductive hormones.   "
101844|NCT01953055|"     Current treatment options for high risk localized prostate cancer include radical     prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation     therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3     Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity     to large fraction sizes and high dose per fraction radiotherapy theoretically allows for     biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope     to determine the toxicity, quality of life, biochemical and pathological control of SBRT for     high risk prostate cancer incorporating ENI.   "
101845|NCT01953042|"     This study will examine the effect of offering information sessions to a randomized group of     patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment;     though intended to be informative in nature, these psychoeducation services can have a     positive effect on quality of life, sense of self-efficacy, functioning and a person's     readiness to engage in long term treatment. However, no studies have dismantled and tested     the independent effect of psychoeducation from standard treatment such as Cognitive     Behavioural Therapy. This study aims to directly test the potential effect of one aspect of     CBT that if found to be helpful, can become a distinct early intervention component of care     so that as people await services, they can profit from the early benefits associated with     attending these information sessions. This study therefore sets out to examine the potential     early benefits of providing education about the illness on symptom functioning, quality of     life and readiness to engage in more formal treatment. We will offer 4 structured information     sessions to individuals allocated to a wait list for services related to the treatment of OCD     and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic     structured psychoeducation program to our services. The study will be a randomized trial     where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions     covering information on diagnosis, treatment, available resources and self care for OCD and     OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions.     The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated     measures factorial design. It is hypothesized that subjects participating in the     psychoeducation group compared to the wait list control group will see greater reductions in     self-reported measures of symptom severity and improvement in other measures of quality of     life, level of functioning, self-efficacy and readiness to engage in treatment. If this study     can demonstrate that the addition of a short structured informative intervention of 4     sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders,     then it provides another route by which patients can improve this condition specifically     while waiting for consultation and the opportunity to receive a more structured,     evidence-based treatment.   "
101846|NCT01953029|"     The objective of our work to determine the mechanisms of myocardial infarction in women     without obstructive coronary artery disease.   "
101880|NCT01952587|"     Short title :      X-linked biological response to HIV sensing: the ANRS EP 53 study.      Main outcome :      To demonstrate that HIV-infected women carry the TLR7 c.32A>T SNP at a higher frequency than     uninfected women, arguing in favor of a role of impaired production of IFN-alpha by pDCs in     the risk of becoming infected by HIV-1.      Secondary outcome :      To directly demonstrate at a single cell level that the TLR7 c.32A>T SNP is responsible for a     reduce production of IFN-alpha by pDCs after activation of TLR7 by HIV-1 RNA.      Short abstract (public dissemination) :      Male and female display some differences in how their immune system responds to pathogens.     This could be related to hormonal or genetic factors located on the X chromosome. This     project aims at characterizing X-linked factors that can influence the innate immune response     to HIV-1.   "
101848|NCT01953003|"     Options for the treatment of patients who have progressed after an anthracycline and a taxane     are limited. Capecitabine currently has a role in this setting, yet as many as 80% of     patients do not respond to this treatment and those who respond eventually develop clinical     resistance.      The antitumour activity of vinflunine has been demonstrated in patients with breast cancer     after exposure to anthracycline and to taxane.      Vinflunine plus capecitabine has been shown to be a feasible combination for patients     previously treated with an anthracycline and a taxane. Each drug in combination can be     administered at efficacious doses.      This population has few therapeutic options with established clinical benefit. The     development of a new regimen and potential new standard of care for this group is important.        -  Primary objective:           • to compare in patients with advanced breast cancer pretreated with anthracycline and          taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine          alone, in terms of progression-free survival.        -  Secondary objectives:             -  to evaluate the response rate, the time to response and the duration of response in               both arms             -  to compare the disease control rate between arms             -  to evaluate the duration of disease control in both arms             -  to evaluate the overall survival in both arms             -  to evaluate safety      Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of     334 patients with advanced breast cancer who have previously been treated with an     anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus     capecitabine (Arm A) or capecitabine alone (Arm B).   "
101849|NCT01952990|"     The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray     containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy     pediatric subjects.   "
101850|NCT01952977|"     The purpose of this study is to test the effects of medium chain triglyceride consumption,     relative to long chain triglycerides, on hormones involved in appetite regulation and food     intake in overweight men. We expect medium chain triglycerides to reduce appetite and food     intake and to do so by increasing levels of hormones known to be involved in satiety and     reduce levels of those involved in appetite.   "
101851|NCT01952964|"     The present study aims to compare the differences in exit site infection between patients     receiving spray dressing and conventional care. The outcome measures including catheter exit     site infection rate, skin allergy, catheter damage and patient satisfaction   "
101852|NCT01952951|"     The current standard treatment of locally advanced rectal cancer (clinical stage II or III)     is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can     be suboptimal for patients with high risk features (more deeply-seated tumor or many regional     lymph nodes involved)that are associated with recurrence. This study test a hypothesis that     CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.   "
101853|NCT01952938|"     Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery.     Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical     follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters   "
101893|NCT01952418|"     The goal of this study is to compare the adenoma detection rate achieved while using either a     24 video monitor or a 32 video monitor.   "
101855|NCT01952912|"     The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might     yield functional results comparable to OP but with lower perioperative morbidity, and have     equivalent long-term efficacy with OP for large prostates. The first objective was to     demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year     postoperatively.      To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP     with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up     period of 6 years.   "
101856|NCT01952899|"     Objective: Delirium is an important and frequently occurring complication in intensive care     patients. However, screening and treatment of delirium is not in accordance with current     national and international guidelines. The first objective of this prospective study is to     describe the barriers and facilitators for guideline adherence. Second, investigators will     develop a tailored implementation strategy. Finally, investigators will describe the effects     of the tailored implementation on the adherence of the guideline in a pilot study. Design:     Current practices, attitudes and deviations from a national (Dutch) delirium guideline will     be assessed in a prospective before-measurement. Barriers and facilitators will be identified     with surveys and focus group interviews. Adherence to the guideline will be studied in a     before-after study in 7 ICUs in the Southwest of the Netherlands. Further, the effect of a     multifaceted implementation strategy-guided implementation will be assessed with regard to     important clinical outcomes, such as mortality and delirium incidence. Population:     Professionals (Physicians/intensivists, nurses' and psychiatrists) and ICU patients.     Intervention: The delirium guideline of the Netherlands Society of Intensive Care (NVIC) is     implemented in this study. Implementation strategies: Barriers and facilitators will be     determined in focus group interviews (n=7) with health care professionals resulting in a     tailored guideline implementation strategy. In the development of the strategies specific     attention will be paid to sustaining the guideline adherence. Main outcome: 1. Current     practices; 2. Barriers and facilitators for guideline adherence; 3. Tailored implementation     strategy; 4. Percentage of adherence to the guideline (early screening, prevention and     treatment of delirium); 5. Effects of implementation on outcomes (economic, mortality,     delirium incidence). Data analysis / power: The main effects, guideline adherence, will be     evaluated by comparing the before and after measurements. Calculating from 90% power,2-sided     alpha=0.01, 231 patients per periods will be sufficient to test the proposed adherence of     85%. Economic evaluation: The economic analysis will be performed from a health care     perspective. Investigator will calculate and compare the direct medical costs of usual care     (before) and care after implementation of the guideline. Additionally, the cost of the     tailored guideline implementation process will be calculated. The economic analysis will be a     cost-minimalization analysis.   "
101857|NCT01952886|"     The purpose of this study is to assess patient satisfaction, the efficacy and compliance of     granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in     malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant     temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing     compliance.      All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY     of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized     to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will     received the other medication. The granisetron transdermal delivery system (supplied as a 52     cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours     before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken     once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out     questionnaires regarding the effectiveness of the medication and their satisfaction, and     which anti-emetic they prefer.      Safety will be assessed throughout the six weeks of radiation by the clinical research nurse     using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who     receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be     included in analyses of treatment preference. However, all other efficacy and safety analyses     will include all subjects who received ondansetron or GTDS.   "
101858|NCT01952873|"     It is universally accepted that high-pressure balloon inflation is required to most     effectively deploy a coronary balloon-expandable stent. However, there is not consensus nor     are there any guidelines regarding the method of balloon inflation, particularly the duration     of inflation. Underexpansion and strut malapposition after stent deployment are among the     most powerful predictors for adverse vessel outcomes. High-pressure inflation for stent     deployment is effective to optimally expand the stent, but unlike in vitro testing in air,     there are poorly distensible plaque elements that may not instantaneously yield to the     balloon pressure. However, these elements may ultimately yield to prolonged inflation. Most     clinical interventional cardiologists inflate for a relatively short period (15-30 sec). The     investigators have noted that when balloon pressure is maintained at a certain pressure level     it tends to decrease over time, and may require 60-180 or more seconds to maintain pressure     stability. This finding implies that plaque elements are yielding slowly over time to the     increased pressure, thus increasing expansion, and suggests that a prolonged inflation until     balloon pressure stabilizes is more effective than a rapid inflation/deflation sequence to     fully expand and appose the stent to the vessel wall. At present there is no consensus on     stent deployment strategy. It is our hypothesis that prolonged inflation is superior to the     more commonly used strategy of rapid inflation/deflation.      Optimal coherence tomography (OCT), a novel technology that measures near-infrared light     reflections and translates them into a 2D image, has an axial resolution nearly 10-times that     of intravascular ultrasound (IVUS). Thus it is possible to examine the extent of stent     apposition and stent expansion using this modality.      The current randomized trial tests the hypothesis that prolonged balloon inflation until a     stable balloon pressure is maintained is more effective than a rapid inflation/deflation     sequence when performed to the same balloon inflation pressure.   "
101859|NCT01952860|"     The goal of this research study is to learn the opinion of patients and their caregiving     about a couple-based Hatha Yoga program during treatment for cancer. Researchers also want to     learn the effect of this program on lung function, distress, and quality of life.   "
101860|NCT01952847|"     The goal of this clinical research study is to learn if glutamine can help control and     prevent sores, blisters, or inflammation in your mouth or esophagus due to your current     treatment.      In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks     like the drug but is not designed to treat any disease or illness. It is designed to be     compared with a study drug to learn if the study drug has any real effect.   "
101861|NCT01952834|"     The study is being performed to determine whether probiotics (GoodBelly) improves blood     vessel function.Probiotics similar to yogurt are living micro-organisms (beneficial to its     host) the lives in the intestine. Patients who have coronary artery disease will be enrolled     in this study. The research results will be used to determine if the type of bacteria present     in the intestines play a role in the pathogenesis of cardiovascular disease. Patients with     coronary artery disease will be enrolled for up to 12 weeks. Patients will take the probiotic     for 6 weeks. Following the 6 week period there is a washout period of 4 weeks, and an     optional antibiotic study called vancomycin. Patients will take the vancomycin for 10 days.     Blood vessel function will be measured by ultrasound before and after the probiotic     supplement and vancomycin antibiotic. Blood will also be taken before and after to evaluate     for markers of inflammation.   "
101862|NCT01952821|"     The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30     Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory     as reliable and valid outcome measurements for patients with head and neck cancer.   "
101863|NCT01952808|"     This project will broadly explore the efficacy of community participation in the design and     implementation of an intervention to improve physical activity and nutrition among immigrant     and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota   "
101864|NCT01952795|"     The purpose of this study is to determine the impact of diet and physical exercise program on     pregnancy rate and live birth in obese women who undergo an IVF cycle.   "
101867|NCT01952756|"     1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely          associated with coronary risk factors and atherosclerotic diseases such as PAOD.        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of          cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of          action in patients with mild-to-moderate PAOD.   "
101868|NCT01952743|"     We propose a pilot study to assess safety and benefit of renal artery ablation at the time of     planned atrial fibrillation ablation.   "
101869|NCT01952730|"     This study is a Pilot clinical trial. Pilot clinical trials test the safety of an     investigational combination of drugs. Pilot studies provide information on what effects, both     good and bad, the Investigational agent might have on your disease. Investigational means     that the intervention is still being studied and that research doctors are trying to find out     more about it. It also means that the FDA has not approved the treatment for your type of     cancer.      The main purposes of this study are to determine:        -  The amount of vaccine that can be made for your colorectal tumor cells        -  If the vaccine can be given safely        -  What the effects of the vaccine are, both good and bad        -  How the vaccine affects your immune system        -  Whether this vaccine might have any effect on the return of your cancer in the liver          after surgical removal      This study is being done because there are currently no treatments which have demonstrated to     cure diseae which has progressed, or moved beyond the site of the primary site of disease     (colon or rectum). These vaccinations will be given after you have completed the standard of     care treatment as determined by your doctor.      Laboratory research has made vaccines from cancer cells by inserting genetic material from a     protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer     cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The     vaccine made form these cells has a greater anti-tumor effect than cancer cells without     GM-CSF. The purpose of this research study is to determine the safety of an investigational     vaccine that will be made using your own colorectal cancer cells in the manner described     above.      This vaccine has been used in several other research studies for treatment for other cancers     (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies     suggests that this vaccine may help to reduce the risk of your colorectal cancer returning     after you have your colorectal cancer surgery.      Due to these results in melanoma and several other tumors we are encouraged to use this     vaccine approach in patients with liver metastases from colorectal cancer, after the cancer     in the liver has been removed by surgery.   "
101870|NCT01952717|"     A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D     Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the     Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).   "
101881|NCT01952574|"     Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by     open-label phase. To evaluate the effect of AMG 334 compared to placebo on the change from     baseline in monthly migraine days   "
101882|NCT01952561|"     Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring     containing 25 mg worn for 1, 2, 4, 8 or 12 months.   "
101883|NCT01952548|"     This study will test single doses of the study drug in increasing amounts to see if it is     safe.   "
101884|NCT01952535|"     The objectives of this study is to determine the safety profiles, tolerability,     pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy     adult subjects.   "
101885|NCT01952522|"     This study is designed to determine if adding daily weighted braces on the unaffected ankle     may benefit to patient who have returned home compare to a placebo intervention (ankle brace     without weight).   "
106261|NCT01895153|"     The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in     patients with bladder pain syndrome.   "
101871|NCT01952704|"     Aerobic exercise holds a multitude of health benefits. Studies in mice have shown that     aerobic exercise improves memory, and increases the volume of the hippocampus, the brain's     primary memory center. Only two studies have been conducted in humans, one in healthy elders,     and the other in a schizophrenia population. So far, there has never been an aerobic exercise     trial in traumatic brain injury (TBI) to look at hippocampal volume and memory as outcomes of     interest. The proposed project is a randomized controlled trial of aerobic exercise in     persons with TBI. We will conduct a 12-week (36 sessions) program of aerobic exercise     (stationary cycling), versus a control condition of non-aerobic exercise (stretching), in     memory-impaired TBI patients to a) increase hippocampal volume and b) improve memory.     Importantly, we also expect benefits of aerobic exercise on the level of brain function.     Specifically, we will look at 'functional connectivity,' which refers to how efficiently     remote regions of the brain 'talk' to each other. TBI is an ideal population to benefit from     aerobic exercise, given the young age at which many individuals sustain TBI, which allows for     benefits of aerobic exercise to be maximally realized in a population with sufficient     neurofunctional reserve. The expected benefits of aerobic exercise (increased hippocampal     volume, improved memory) from this intervention stand to have a meaningful impact on people     with TBI, including improved health, productivity, independence, and quality of life. And,     unlike current treatments for memory impairment (e.g., pharmacological agents, cognitive     rehabilitation), aerobic exercise is a cost-effective, all natural, readily-available     treatment for memory problems.   "
101872|NCT01952691|"     The main aim of this study was to find the initial effects of kinesiotaping on pain and joint     alignment used in the conservative treatment of hallux valgus.      22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping was     implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main     outcome measures were the pain hallux adduction angle. Kinesiotaping may be an effective     treatment option in decreasing pain and deformity in hallux valgus deformity who are     conservatively treated. In future studies this method might be shown in larger sample groups     at longer periods of treatment comparing with alternative treatment approaches like exercise     or orthotics.   "
101873|NCT01952678|"     The primary objective of this study is to determine if the diagnostic performance of DaTscan™     single photon emission computed tomography (SPECT) imaging is different in non-Caucasian     subjects compared with Caucasian subjects with movement disorders.   "
101874|NCT01952665|"     A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over     1 Month of Daily Wear   "
101875|NCT01952652|"     In this study, the aim is to compare the efficacy of single dose naproxen sodium and     combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients     undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more     advantageous than naproxen alone.   "
101876|NCT01952639|"     Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a     major impact on our health care system due to increased morbidity and greater need for     hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to     improve dietary intake of the elderly. Both whey and casein seem to offer an anabolic     advantage over soy protein for promoting muscle hypertrophy. As a consequence it is assumed     that (all) plant based proteins have less potent anabolic properties when compared with     animal based proteins. However, there is little theoretical background for such assumptions.      Objective: To provide evidence for the efficacy of wheat protein and wheat protein     hydrolysate when compared with milk proteins (i.e. whey and casein) as a dietary protein to     stimulate postprandial muscle protein synthesis in vivo in healthy older humans.      Study design: double-blind, placebo-controlled intervention study Study population: 60     healthy non-obese (BMI 18.5-30 kg/m2) older males (age: 65-80 y) Intervention: A protein     beverage (350 mL) containing 30 g of whey, casein, wheat protein, or wheat protein     hydrolysate or 60 g of wheat protein hydrolysate will be consumed (n=12 per group).      Main study parameters/endpoints: Primary study parameters include muscle protein synthesis     rates. Secondary study parameters include whole-body protein synthesis, breakdown, oxidation,     and net balance.      Hypotheses: We hypothesize that ingestion of wheat protein hydrolysate results in a greater     muscle protein synthetic response when compared with the intact wheat protein due to its     faster digestion and absorption. Furthermore, ingestion of wheat protein hydrolysate results     in a higher muscle protein synthetic response when compared with casein, but lower when     compared with whey protein. Ingestion of 60 g of wheat protein hydrolysate (amount of leucine     equal to 30 g of whey protein) will result in a similar muscle protein synthetic response     compared to ingestion of 30 g of whey protein.   "
101909|NCT01952210|"     In this randomized pilot study, a nutritional consultation combining exercise program is     planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant     chemoradiation. The purpose of this study is to determine the effects of nutritional and     exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant     chemoradiation.   "
146018|NCT01373034|"     The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea     predominant irritable bowel syndrome.   "
101877|NCT01952626|"     Intrathecal administration of morphine is often used for control of postoperative pain.     However, pruritus is one of the most common side effects of intrathecal morphine . Specific     serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial     opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron     for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated     the efficacy of prophylactic administration of ondansetron and palonosetron for the     prevention of intrathecal morphine-induced pruritus.   "
101878|NCT01952613|"     Our proposal quantitatively analyzes gait dynamics of hemiplegic individuals in response to     the Function Electrical Stimulation (FES) intervention and identifies the responders to the     intervention. This study will improve our knowledge of FES intervention and help clinicians     strategize the FES interventions more effectively based on the responders' gait     characteristics, thus supporting the NINDS' fundamental goal of translating basic and     clinical discoveries into better ways to prevent and treat neurological disorders.   "
101879|NCT01952600|"     The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic     kidney disease (CKD) patients' priorities; assessing the comparative benefits of hemodialysis     (HD) versus peritoneal dialysis (PD), with respect to these priorities; and providing     tailored information to assist patients with identifying the best dialysis modality fit for     their own unique circumstances and perspectives.      The outcomes most relevant to patients (patient-centered) extend beyond those traditionally     assessed in clinical research, with the relative importance varying across patient groups. A     tailored decision aid based on these findings can improve patient decision-making processes     regarding choice of dialysis modality.   "
102422|NCT01945502|"     The purpose of this study is to assess the efficacy of three different pharyngeal packing     during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and     to evaluate the influence of pharyngeal packing on postoperative throat pain.   "
101888|NCT01952483|"     Assessing the immune activation in MS patients deficient in Vitamin D and whether Vitamin D     supplementation reverse the immune activation      Evaluating whether Vitamin D deficiency result in lower cognitive performance in MS patients     and the effect of Vitamin D supplementation on reversing the cognitive impairment?   "
101889|NCT01952470|"     Patients who have undergone lung transplantation are at an increased risk of developing chest     infections due to long-term medication suppressing the immune response. In other chronic lung     diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic     medication such as dornase alpha and isotonic saline are often used as part of the management     of lung disease characterized by increased or retained secretions. These agents act by making     it easier to clear airway secretions, and are currently being used on a case-by-case basis     post lung transplantation.      To the investigators knowledge, these agents have not been evaluated via robust scientific     investigation when used post lung transplant, yet are widely used in routine practice.     Patients post lung transplant must be investigated separately as they exhibit differences in     physiology that make the clearance of sputum potentially more difficult when compared to     other lung diseases. Lower respiratory tract infections are a leading cause of hospital     re-admission post lung transplant. Therefore, this highlights the need for a randomized     controlled trial. The aim of this study is to assess the efficacy of dornase alpha, compared     to isotonic saline, in the management of lower respiratory tract infections post lung     transplant. Investigators hypothesize that dornase alpha will be more effective than isotonic     saline.      The effect of a daily dose of dornase alpha and isotonic saline will be compared over a     treatment period of 1 month. Patients admitted to hospital suffering from chest infections     characterized by sputum production post lung transplant will be eligible for study inclusion.     Patients will be followed up through to 3 months in total to analyze short-medium term     lasting effect. Investigators wish to monitor physiological change within the lung     non-invasively via lung function analysis whilst assessing patient perceived benefit via     cough specific quality of life questionnaires. These measures will be taken at study     inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed     via patient symptom diaries, incorporating hospital length of stay and exacerbation rate. The     outcomes of this study have the potential to guide clinical decision-making and highlight     safe and efficacious therapies.   "
101890|NCT01952457|"     The objective of this clinical investigation is to evaluate the early and mid-term outcome     (after 6 and 12 months) and the long-term (up to 24 months) outcome of the Zilver PTX     paclitaxel-eluting stent (Cook) versus bypass surgery for the treatment of TASC C&D     femoropopliteal lesions.   "
101891|NCT01952444|"     Evaluate the safety and tolerability of intravenous (IV) ETI-204 alone and in the presence of     IV and oral ciprofloxacin   "
101892|NCT01952431|"     A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring TLC     (total lung capacity) compared to TLC measured by standard body plethysmography using the ZAN     500. The study will be conducted as a prospective two-arm, open, randomized comparative     study.   "
101894|NCT01952405|"     The purpose of this study is to test the hypothesis:      Primary hypothesis: Participants in the dialectical behavior therapy group have greater     reductions in the frequency and severity of suicidal and non-suicidal self-injurious     behaviors compared to participants in the alternative treatment group.      Secondary Hypotheses: Participants in dialectical behavior therapy group have improved     treatment outcomes compared to participants in alternative treatment, including mental health     service utilization, symptoms of borderline personality and depression symptoms, suicidal     thought and hopelessness, disability, and quality of life.   "
101895|NCT01952392|"     Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome   "
101896|NCT01952379|"     Melasma is an acquired hyperpigmentary disorder that commonly affects women from Asia and     Latin-America.There is evidence of subclinical inflammation supported by diffuse spectrometry     and by prominent inflammatory cells in affected areas; however this infiltrate and its     inflammatory mediators remains unexplored. Chronic inflammation induces melanogenesis and     angiogenesis; thus, it could be linked to its recurrent nature.Therefore, the aim of this     study is to describe the inflammatory cellular infiltrate, and the expression of main     inflammatory and angiogenic mediators in this condition, as well as to explore its     relationship with severity of disease.      Using histological, histochemistry, immunohistochemistry, and quantitative real-time PCR, we     evaluated melasma lesions from 20 healthy female patients with malar melasma without specific     solar exposure or photoprotection measures within the previous 3 weeks and compared them to     non lesional skin.   "
101897|NCT01952366|"     PRODE is a Norwegian multicentre study investigating the prognosis of depression in the     elderly. The study has included 169 patients who will be followed with assessments after one     and three years.      The study hypothesis is that elderly patients referred to specialist health service have a     poor long term prognosis.   "
101898|NCT01952353|"     Whether preoperative transarterial chemoembolization can prolong survival for the resectable     hepatocellular carcinoma remains controversial, particularly in patients with portal vein     tumor thrombi. This study designs to systematically identify and summarize the effect of     preoperative TACE for resectable HCC with portal venous invasion.   "
101899|NCT01952340|"     The World Health Organization has deemed high blood pressure as a global crisis because it is     the number one risk factor associated with most deaths worldwide. Therefore, the need for     effective and desirable treatment options is vitally necessary. The purpose of the current     investigation is to determine the efficacy of a new therapeutic strategy: flaxseed. The aim     is to determine the efficacy of consuming milled flaxseed every day for 6 months on the     reduction of blood pressure in individuals newly diagnosed with high blood pressure yet to     receive any blood pressure lowering medications. Secondary objectives are to understand how     flaxseed at the molecular level can reduce blood pressure. The study hypothesis is that the     flaxseed group will exhibit significant reductions in blood pressure and therefore not     require any blood pressure lowering medication. The aim is to provide knowledge on a new     therapeutic strategy to help manage high blood pressure.   "
101900|NCT01952327|"     This is a research study examining the safety of a new, automated pump for the drainage of     fluid in the chest cavity which is caused by cancer (also known as malignant pleural     effusion, or MPE). The purpose of the trial is to assess whether the new pleurapump device is     safe and effective in the management of patients with MPE. The study will try to identify     what kind of problems may arise from using the device, how often they happen, and how severe     they are if they occur.   "
101901|NCT01952314|"     This study is to investigate whether naftopidil is effective or not for the spontaneous     passage of ureteral stones with sizes of 3 to 10 mm.   "
101902|NCT01952301|"     A split-mouth study comparing soft tissue augmentation results using free gingival graft     (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT)     around teeth with insufficient (< 2mm) KT.   "
101903|NCT01952288|"     Study of simvastatin in Iraq/Afghanistan Veterans with multiple blast exposure and mTBI. The     study will measure substances in cerebrospinal fluid (CSF) that are related to dementing     disorders.   "
101904|NCT01952275|"     This study investigates the genetic architecture of Neutrophil-Mediated Inflammatory Skin     Diseases. After collecting informed consent, all patients' clinical phenotype is graded at     inclusion with a detailed case report form and a discovery cohort formed based on the     certainty of diagnosis. The DNA of patients in the discovery cohort is analyzed by whole     exome sequencing which identifies all protein-coding genetic variants. Subsequently,     statistical burden tests are going to identify enrichment of rare coding genetic variants in     patients affected by Neutrophil-Mediated Inflammatory Skin Diseases.      The ultimate goal is to reveal the responsible gene(s) that may then be targets for clinical     intervention.   "
101905|NCT01952262|"     Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically     ill patients admitted in a teaching hospital intensive care unit will be evaluated with     diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical     course of these patients.      Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with     diaphragm ultrasound before and after surgery irrespectively of the need of intensive care     unit. On December 2014 the Etical committee approved an amendment to include the possibility     to study elective aortic abdominal surgery patient to assess the relationship between surgery     related diaphragmatic dysfunction and postoperative respiratory complications.   "
101906|NCT01952249|"     This is a Phase 1b/2 study of paclitaxel plus demcizumab in subjects with platinum resistant     ovarian, primary peritoneal or fallopian tube cancer.   "
101907|NCT01952236|"     This study seeks to develop and then perform a controlled efficacy Randomized Controlled     Trial assessing tobacco abstinence of a best-practices Web-based smoking cessation     intervention combined with a Mobile intervention. Study participants are randomized to one of     two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis is     that the Web+Mobile approach will yield greater efficacy than the Web Only condition.   "
101908|NCT01952223|"     The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic     radiotherapy in combination with ADT-radiotherapy on clinical progression-free survival in     patients with high-risk localized prostate cancer (with a stringent selection of patients     with at least 2 high-risk features), in a 2 by 2 factorial trial.   "
101912|NCT01952171|"     Recent advances in genomic techniques are making possible a new wave of genetic discovery in     congenital heart disease (CHD). Existing data suggests that CHD occur in Sub-Saharan Africa     at frequencies similar to the rest of the world. In this application, we propose to utilize     the unique advantages of Sub-Saharan Africa - a combination of the most genetically diverse     populations in the world and of diminished environmental background effects (i.e. low     prevalence of smoking, alcohol abuse, obesity in comparison to western countries) - to better     understand the genetic basis for congenital heart disease. We will couple next generation     genomic techniques with more traditional gene discovery methods to investigate CHD in two     African countries: Uganda and Nigeria. The inclusion of syndromic and non-syndromic CHD     observed in these populations as well as careful phenotyping (including echocardiography)     will greatly enhance our potential to provide insight into the genetic architecture of CHD in     African populations. To accomplish this, we plan to enroll families, in whom members have     congenital heart malformations consistent with an error of early human development in our     research protocol. Patients will be enrolled at the Uganda Heart Institute in Kampala,     Uganda, and at the Department of Pediatrics, College of Medicine, University of Lagos,     Nigeria, with the potential to include other African sites. High throughput genomic studies     will be done at the NIH.   "
101913|NCT01952158|"     Acquisition and transmission of MDROs in healthcare facilities is a major patient safety     problem, afflicting in particular the antibiotic-exposed and immunodeficient patient     populations. MDRO-colonized patients require isolation to reduce the risk of transmission to     other patients, and frequently develop infections from their colonizing organisms.      Most clinically relevant MDROs are carried in the gastrointestinal tract; thus perirectal     cultures are frequently the surveillance method used to screen for these pathogens.     Surveillance to identify MDRO colonization allows for anticipation and timely initiation of     effective treatment of patients who develop infection.      The precise modes of transmission within hospitals are not known, but contamination of the     hands of healthcare personnel, patient care equipment, and the healthcare environment are     thought to play major roles in transmitting MDRO. Suboptimal hand hygiene can lead to     transmission on the hands of staff to other patients or colonization of their own     gastrointestinal tract. Few studies have investigated intestinal colonization of healthcare     professionals. Transmission of bacteria by healthcare personnel is thought to occur primarily     via contaminated hands; we wonder whether gastrointestinal carriage by healthcare personnel     also plays a role in nosocomial spread.      This study will screen a self-referred convenience sample of 400 healthcare personnel who     have contact with patients or patient culture specimens for fecal carriage of MDRO at one     point in time. A control group of 400 NIH employees or contractors who do not have contact     with patients or patient specimens will also be screened. Samples will be linked to     questionnaires to assess the exposure of staff members to patients or culture specimens with     known MDRO colonization or infection. We will use molecular typing techniques to link     healthcare personnel isolates to patient or environmental isolates. Finally, the study will     be conducted in such a way as to preserve to the greatest extent possible the anonymity of     volunteers, using a system of alphanumeric identifiers and unmanned drop boxes for specimen     collection.   "
101914|NCT01952145|"     This trial is conducted globally. The aim of the trial is to compare the efficacy and safety     of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes     mellitus.   "
101915|NCT01952132|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.   "
101916|NCT01952119|"     This study will assess whether adding a secure message reminder to routine care improves the     percentage of patients who complete a follow-up appointment with a new, documented blood     pressure reading.   "
101917|NCT01952106|"     The main purpose of this study is Investigating the effectiveness of distraction by     evaluating the children's perception of pain during venepuncture.   "
101941|NCT01951794|"     Validate a promising community survey methodology for evaluating the Prevention of Mother to     Child Transmission (PMTCT) program effectiveness against a gold standard cohort design and     to identify individual- and facility-level characteristics associated with HIV-free survival     among HIV-exposed infants.   "
101967|NCT01951443|"     The purpose of the study is to evaluate the acute effect of a standardized extract of KRG     (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial     stiffness and blood pressure, as measured by the following parameters: aortic augmentation     index, peripheral blood pressure, central blood pressure   "
101968|NCT01951430|"     The purpose of this study is to observe the number of new cases of infections per population     in a given time period and their characteristics in a pathology (myelodysplastic syndrome,     MDS)that involves ineffective production (or dysplasia) of a class of blood cells.   "
101918|NCT01952093|"     Despite the remarkable achievements in neonatal survival of preterm infants with very low     birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have     produced little change in their prevalence of severe developmental disability and the rate of     low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit     hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills     and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs     developed for preterm infants in Western societies were shown to have short- to long-term     benefits in certain cognitive functions, however rare studies have investigated intervention     effect at school age and explored plausible neurological pathway for effective intervention.     This three-year study is therefore aimed to extend our previous research to longitudinally     examine the effectiveness of three intervention programs (clinic-based intervention program     [CBIP], home-based intervention program [HBIP] and usual care program [UCP]) for VLBW preterm     children in Taiwan at seven years of age.(The intervention had been delivered from birth to     one year of corrected age in the previous study. Intervention will not be given in this     study.)The CBIP and HBIP contained similar child- and parent-focused services as well as     interaction activities but were respectively delivered at clinic for the CBIP and at home for     the HBIP. A total of 178 VLBW preterm infants have been randomly assigned to the CBIP, HBIP     or UCP. Sixty-two gender and maternal education level matched term children with normal birth     weight have also been included to serve as the reference group for comparison of     developmental outcomes. Effectiveness examined will include child and parent outcomes. The     long-term effect of early intervention for preterm children will provide important     information to help medical professionals and public policy makers to develop effective     intervention for Taiwanese preterm children who are at risk of developmental disorders.   "
101919|NCT01952080|"     This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide     in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into     an observational cohort who will receive standard of care. Three doses of teduglutide are to     be investigated for 12 weeks. All subjects will be screened prior to the start of treatment     (SOT) to establish baseline characteristics including safety, eligibility and nutritional     support parameters.   "
101920|NCT01952067|"     The primary aim of the study is to compare migration of the cemented Corail stem representing     polished surfaced versions of the femoral stem. Two different methods will be used for     reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be     used in migration measurements.      Furthermore pain, postoperative outcome and patient satisfaction will be assessed.   "
101921|NCT01952054|"     The goal of this clinical research study is to learn if denosumab in combination with a     hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with     breast cancer that has spread to the bone. The safety of this combination will also be     studied.   "
101934|NCT01951885|"     This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and     methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in     patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant.     Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin     inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity     than standard dose methotrexate. It is not yet known, however, whether this combination of     mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than     tacrolimus and standard dose methotrexate in preventing GVHD.   "
102817|NCT01940354|"     The study will test a hypothesis that the AccuCath™ System will have a higher rate of     successful first attempt peripheral IV placement and higher clinician and patient     satisfaction compared to Conventional IV Catheters.   "
101922|NCT01952041|"     The study is a three year research project whose aims are to design and test a     state-of-the-science smartphone Ecological Momentary Assessment (EMA) and sensor technologies     to provide mobile monitoring of schizophrenia to detect early signs of relapse. The proposed     system will be used to continuously capture multidimensional behavior as it occurs in     real-time and in real-world environments, detect individual early warning signs, and trigger     targeted interventions that may mitigate the severity of relapses or prevent their recurrence     altogether. Mobile sensors include paralinguistic aspects of speech, physical activity and     location, and sleep. The first hypothesis is that mobile sensing and EMA techniques will     capture early behavioral warning signs. The second hypothesis is that machine learning,     coupled with user input, will enable development of individualized predictive risk     signature models. The third hypothesis is that automated system patient and provider     functions will help prevent psychotic relapses.   "
101923|NCT01952028|"     Laminin alpha-2 (LAMA2)-related muscular dystrophy (LAMA2-MD, Merosin Deficient CMD) is a     form of congenital muscular dystrophy (CMD). A person with LAMA2-MD will have changes on     brain imaging (MRI), a decrease or absence of the protein merosin (laminin 211) on muscle or     skin biopsy and changes in the LAMA2 gene that are inherited from both parents. Several     studies have described the changes on brain MRI. Brain changes on MRI do not correlate with     the partial reduction or absence of merosin on muscle or skin biopsy. 8-30% of people with     LAMA2-MD develop seizures. The types of seizures, electroencephalogram changes and common     treatment regimens have not been characterized. This study will review the magnetic resonance     imaging (MRI) changes, determine whether certain brain MRI changes are linked to seizures and     define the common seizure treatment regimens.   "
101924|NCT01952015|"     The purpose of this study is to assess efficacy and safety data of secukinumab in Japanese     subjects with generalized pustular psoriasis (GPP). This study is expected to support the     filing of secukinumab in the indication of pustular psoriasis in Japan.   "
101925|NCT01952002|"     The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic     responses during an inspiratory muscle training session during a single cardiopulmonary     rehabilitation session program. An electrocardiogram will be continuously recorded and the     heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately     after a single inspiratory muscle training (IMT) session, consisting of two series of 15     cycles, with one-minute intervals between sets and an initial load of at least 30% of the     initial maximal inspiratory pressure (MIP).   "
101954|NCT01951625|"     Objective of the study is to find the optimal dose of the once daily oral soluble guanylate     cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard     therapy for heart failure with reduced ejection fraction (HFrEF).   "
101983|NCT01951235|"     This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus     placebo. The study will be performed in subjects with type 2 diabetes either naive of     treatment or previously treated with an oral monotherapy excluding thiazolidinedione.   "
102423|NCT01945489|"     This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared     with placebo, in achieving a 100% reduction in urinary incontinence in patients with     overactive bladder (OAB) not properly managed with an anticholinergic.   "
101926|NCT01951989|"     Rational: Imiglucerase has been used to treat Gaucher disease since 1997 but data about its     pharmacokinetics have been partial; investigators know that imiglucerase undergoes a quick     clearance from plasma compartment following the infusion (1/2 life: 1-6 min, from tissue:     <24h), an observation apparently contradictory with usual infusion rhythm (one infusion every     two weeks). Furthermore, by going by GD response, the rhythm of Infusion is sometimes     diminished (for example, every 3 or 4 wks) without pharmacological rational ; In parallel,     investigators demonstrated that monocytes represent a satisfactory surrogate of GD target     cells and that enzyme activity into monocytes varies between individuals.      Our hypothesis is that enzyme activity into monocyte compartment could be different and could     be related to GD response.      Primary purpose: to evaluate the pharmacokinetics of Imiglucerase activity into target     cellular compartment depending on dose and frequency of infusions.      Secondary purposes : 1) to establish a possible relationship between the intra-monocytic     activity of glucocerebrosidase and the clinical and biological activity of Gaucher disease     and to define a possible threshold value of enzyme activity; 2) to establish a better     correlation with known biomarkers of disease (routine markers and markers recently     identified), which would better predict and / or monitor response to treatment ; 3) to     compare the residual and natural rate of activity enzyme intra-monocytic for untreated     patients (low severity disease).   "
101927|NCT01951976|"     The purpose of this study is to determine whether it might be practical and useful to     investigate the effectiveness of yoga classes in relieving joint pain associated with the use     of a class of medications known as aromatase inhibitors.   "
101928|NCT01951963|"     The proposed trial is a prospective, double blinded, randomized control trial with the     primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease     the total narcotic requirements of pediatric patients requiring intravenous analgesia in an     urban emergency department (ED) compared to a group of patients who receive morphine alone     for pain management. Patients are randomized to receive either a single bolus of ketamine     (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be     accomplished using morphine. Patient, family member, and research staff pain scores will be     recorded, until 3 hours post study medication administration. Family members are contacted     via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for     evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be     calculated for up to 3 hours post study medication administration and compared between the     ketamine and morphine groups.   "
101929|NCT01951950|"     Emergence hypertension is a common occurrence in patients emerging from general anesthesia.     This elevation of arterial pressure is particularly concerning in patients undergoing     craniotomy due to increased risk of morbidity and mortality in patients with altered     intracranial elastance. Thus, identifying better methods to attenuate the hemodynamic changes     associated with emergence from anesthesia can improve patient safety, especially in the     neurosurgical patient.      Study Hypothesis: Nicardipine is more effective than esmolol as a sole agent in maintaining     blood pressure within goal range in the setting of emergence hypertension after craniotomy.   "
101930|NCT01951937|"     In the FINS study we test - in a randomized non blinded intervention study- the hypothesis     that increased intake of herring and mackerel will improve cognitive performance of children     aged 4 years to 5 years 8 months in the Munich area (Germany), who habitually consume little     fish.   "
101931|NCT01951924|"     The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use     liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of     MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.   "
101932|NCT01951911|"     To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves     analgesia in patients with neuropathic cancer pain.   "
101935|NCT01951872|"     Recent research has shown that some individuals become addicted to or dependent on caffeine     and are unable to quit or reduce caffeine consumption despite a persistent desire to do so.     The aims of the current study are to characterize caffeine use among individuals with     physical or psychological dependence on caffeine and evaluate a manual-based intervention to     promote caffeine reduction and cessation.   "
101936|NCT01951859|"     This is a study whose primary objective is to assess the effectiveness of Neuropathy/Ulcer     Cream in the promotion of healing skin fissures plantar foot ulcers and as a moisturizer to     prevent dry skin turning into ulcers as compared with a placebo cream containing the same     vehicle as Neuropathy/Ulcer Cream without the active ingredients (Control).   "
101937|NCT01951846|"     The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF     1120 in patients with solid tumours by the monitoring of drug-related adverse events.     Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and     pharmacodynamics.   "
101938|NCT01951833|"     The current dream in CF research is to discover safe drugs that correct the basic defect and     prevent lung disease, allowing patients without significant lung damage to live nearly normal     lives with a dramatic increase in life expectancy and without the burden of current     treatment. The compound VX-770 (Ivacaftor Ò) is hoped to be the first milestone along this     way. Progression of lung disease is now so gradual in many centres that sensitive indicators     of early lung disease (small airways disease) are critically needed to assess the effects of     such new treatments. In this context, assessment of ventilation inhomogeneity by the     measurement called Lung clearance index (LCI) seems to be the most promising tool. However,     to get approval by health authorities, new measures used in drug evaluation need to fulfill     strict criteria. For LCI, the investigators still need to prove its long term significance:     How well does the LCI measurement predict the long term lung disease course? Therefore, in     this study the investigators want to measure LCI at baseline in a large patient cohort and     establish how well it predicts the patients' disease course over the next 2 years.   "
101939|NCT01951820|"     The efficacy of the topical anesthetics will be determined by how much pain the patient felt     (using a Heft-Parker pain analog scale) upon needle penetration.   "
101940|NCT01951807|"     Subjects that have received medical treatment for ovarian cancer can be both physically and     emotionally demanding for patients. The purpose of this study is to determine whether two     common pyschological interventions (Communication Skills Intervention and Supportive     Counseling) may improve the well-being of ovarian cancer patients compared to usual care.   "
101942|NCT01951781|"     Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and     biological markers in the infection initial phase .The aim of this study is to determine the     performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial     infection (NI) in preterm newborns.      METHODS :        -  Monocentric prospective study including preterm newborn infants (<37 weeks of          gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal          intensice care unit (Neonatal intensive care unit of Montpellier, France).        -  Patients will be enrolled in the study after informed consents. Rapid and automated CD64          measurment will be realized during the conventional blood sample including C-Reactive          Protein (CRP), Procalcitonin (PCT) and blood culture.        -  Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded          the result of CD64. Patients will be then classed in three groups using CDC criteria          (center for disease control) : 1-no infection, 2-infection, 3-possible infection during          the multidisciplinary staff. Specificity, sensitivity, negative and positive value of          CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.           153 patients are needed in the study enrolled during a period of 12 months.      PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial     infections in neonates.CD64 allow to integrate in a decision algorithm with the determination     of the best cut-off value to faster processing nosocomial infections and could help to reduce     unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily     available in our unit.   "
101943|NCT01951768|"     The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen     sponge) in combination with antibiotics is safe and effective in treating moderate and severe     diabetic foot infections.   "
101944|NCT01951755|"     An open-label, non randomized clinical trial of Tarceva as single agent in progressed     non-small cell lung cancer patients.   "
101945|NCT01951742|"     The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment     of Crow's Feet.   "
101946|NCT01951729|"     Glucose-dependent insulinotropic polypeptide (GIP) is a hormone produced in the intestine. It     is released immediately after meal ingestion and increases insulin release. This, in turn,     helps reduce blood glucose levels. This circuit does not work properly in humans with type 2     diabetes mellitus (T2DM).      We have previously shown that a peptide called xenin-25 can amplify the effects of GIP on     insulin secretion in humans. However, xenin-25 no longer does this when humans develop T2DM.     Thus, it is important to understand how xenin-25 works in humans without T2DM so we know why     it does not work in humans with T2DM.      Acetylcholine is molecule produced by specific types of nerves. The effects of acetylcholine     can be blocked by a drug called atropine. We have previously shown in mice that atropine     prevents the ability of xenin-25 to increase the effects of GIP on insulin release. The     purpose of this clinical trial is to determine if atropine also blocks the effects of     xenin-25 in humans without T2DM. If it does, then impaired acetylcholine signaling may be one     of the reasons humans develop T2DM and it could be possible to develop drugs that bypass this     defect and increase insulin release in humans with T2DM.   "
101972|NCT01951378|"     The primary objective will be, in an open-label randomized trial, a comparison of emergency     department (ED) length of stay (LOS) between children experiencing acute asthma treated with     two different nebulizers. Secondary outcomes will include admission rates, hospital LOS, need     for additional therapies, transfers to a higher level of care, side-effects, and unscheduled     return visits   "
101947|NCT01951716|"     Glucose-dependent Insulinotropic Polypeptide (GIP) and xenin-25 are peptide hormones     produced/released from your intestines and help regulate blood sugar levels after you eat. We     have previously performed studies in humans that measured the effects of xenin-25 and GIP     (alone and together) on blood sugar levels. One study was conducted with an intravenous     infusion of glucose but without ingestion of a meal. In this study, xenin-25 increased the     effects of GIP on insulin secretion- but only in humans without type 2 diabetes mellitus     (T2DM). A second study was conducted in conjunction with ingestion of a meal. In this study,     xenin-25 reduced blood glucose levels by delaying gastric emptying and this effect was     similar in humans with and without T2DM. A variety of studies that we have performed suggest     that xenin-25 works by activating nerves. A specific nerve called the vagus nerve plays an     important role in regulating insulin secretion. This study will determine if the vagus nerve     (which was disrupted if you had a vagotomy) is needed for the effects of xenin-25 on insulin     secretion and/or gastric emptying.   "
101948|NCT01951703|"     To evaluate the impact of a new contact lens hydration process   "
101949|NCT01951690|"     This is a Phase II, open-label, multicenter, multi cohort, study of VS-6063 (defactinib), a     focal adhesion kinase inhibitor, in patients with KRAS mutant non-small cell lung cancer     (NSCLC). NSCLC with a KRAS mutation is required for study entry and subjects will be enrolled     into 1 of 4 cohorts based on the status of their INK4a/Arf and p53 mutations. The purpose of     this study is to demonstrate if VS-6063 (defactinib) improves PFS within each cohort. The     safety and tolerability of VS-6063, tumor response rate, progression free survival and     overall survival will also be assessed. The pharmacodynamic effects of VS-6063 (defactinib)     will be examined in a tumor biopsy and a blood sample.   "
101950|NCT01951677|"     There is a need for more effective and better-tolerated hepatitis B vaccines for low     responder high-risk populations including patients with renal impairment and/or diabetes     mellitus and those aged over 40 years. Several approaches are available to enhance the     potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens,     replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine     antigen. A combination of these strategies is being tested in this study to identify the most     promising candidate approaches to take forward into advanced clinical development   "
101951|NCT01951664|"     Treatment for head and neck cancer can result in marked musculo-skeletal impairment (MSI).     This study will examine the effects of Hatha Yoga as a therapeutic modality to address MSI.   "
101952|NCT01951651|"     The purpose of this study is to examine the effect of exenatide on liver and heart     (myocardial) fat and inflammation.   "
101953|NCT01951638|"     Objective of the study is to find the optimal dose of the once daily oral soluble guanylate     cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard     diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)   "
101955|NCT01951612|"     Stroke is a leading cause of disability; most strokes (80%) are subcortical, with ischemic     damage due to occlusion in penetrating arteries. Although ischemic white matter disease     (iWMD) may lack gross clinical manifestation, it causes significant cognitive impairment,     particularly on measures of executive function, attention, and memory. This impairment is     attributable to diffuse damage affecting network connections.      While there are many studies concerning rehabilitation of motor function and language in     patients with large focal strokes, few studies have addressed attentional and executive     functions. To our knowledge, there are no such studies on iWMD. In this study, patients will     be randomized to a novel intervention for improving executive function and a control     condition matched for therapist exposure. Patients will be assessed pre-intervention,     post-intervention, and at long-term follow-up using a battery of behavioural and neuroimaging     tasks. We predict that the novel intervention will be associated with improved executive     function, as assessed behaviourally, and improved frontal network function, as assessed     through neuroimaging markers.   "
101956|NCT01951599|"     To determine the relative bioavailability of different oral formulations of AZD9291 and the     effect of food in healthy volunteers.   "
101957|NCT01951586|"     This randomized phase 2 trial is studying the effect of adding denosumab to standard     chemotherapy in the treatment of advanced lung cancer.   "
101958|NCT01951573|"     The purpose of this study is to demonstrate non-inferiority of a new daily disposable     multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA     MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).   "
101959|NCT01951560|"     The purpose of the first part of this study is to determine the safety and tolerability of     ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion     (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects.      The second part of the study will also be to determine the safety and tolerability of single     ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic     shock.   "
101960|NCT01951547|"     Periodontitis, a chronic inflammatory disease which results in irreversible attachment loss,     bone destruction and tooth loss, is a major oral health problem affecting 90.2% of Malaysian     population. It was initially demonstrated that Type 2 Diabetes (T2D) was a risk factor for     periodontitis and subsequently a two-way relationship between diabetes and periodontitis was     proposed. Diabetes has been shown to cause defects in neutrophil function by overproduction     of pro-inflammatory mediators such as Tumour necrosis factor-α, Interleukin-1β and     Prostaglandin E2 by macrophages. The inflammatory mediators released in response to plaque     have been reported to be insulin antagonists that disturb binding of insulin to its receptors     and further complicate hyperglycaemia in T2D. The hyperglycaemia in diabetics promotes more     pathogenic bacteria into the subgingival microenvironment making them more susceptible to     chronic periodontitis. Studies however differ in the types of periodontal pathogens present     in these pockets. At the same time, very few studies have quantified them. This study     proposes to investigate the effect that non-surgical periodontal therapy (NSPT) has on the     periodontal parameters, HbA1c levels, microbiological profile and CRP levels of T2D patients     with chronic periodontitis as compared to oral hygiene education (OHE)alone.   "
101961|NCT01951534|"     This is an intervention development and pilot study whose purpose is to determine the     feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide     preliminary data on its impact on decisional outcomes.      The primary aim of this study is: Is the intervention trial feasible? The purpose is to     develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is     important that this trial provide evidence of feasibility. The investigators will define     feasibility as the rate of study acceptance and participation.      The secondary aim of this study is:  Is the BRDA acceptable and used? The team will     evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict     uptake and use. The investigators anticipate that, due to interest in the topic, the majority     of women will access the website.      An additional secondary aim of this study is: What is the impact of BRDA on BR knowledge,     attitudes about BR, decisional conflict, preparedness and completeness of preparation,     anxiety, and discussion with oncologist? The purpose is to calculate effect sizes for a     larger randomized trial.   "
101962|NCT01951521|"     Randomized controlled trial in which the effect is investigated of a radiation boost in     addition to standard chemoradiation in patients with locally advanced rectal cancer on     complete response rate defined as pathological complete response, in those who undergo     surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait     and see approach. Secondary objectives are adverse events due to chemoradiation (acute,     perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost     on local and distant recurrence and survival as well as patient-reported quality of life and     workability. The need for this comprehensive study is emphasized by the sub-optimal     (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in     this field.   "
101963|NCT01951508|"     The purpose of this study is to investigate effects of methylphenidate, modafinil, and     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) on emotion-processing and cognitive     performance using functional magnetic resonance imaging (fMRI) techniques. The primary     hypothesis is that these psychostimulants differentially affect processing of emotional     stimuli and potentially leading to alterations in social cognition and behavior.   "
101964|NCT01951482|"     This is a multi-center phase II randomized controlled study to assess the efficacy of     Pemetrexed/cisplatin with or without Bevacizumab on patients with brain metastasis from     non-small cell lung cancer(NSCLC) harboring EGFR wild type by intracranial PFS(iPFS),also PFS     ,DCR and OS.The side effect is evaluated as well.   "
101965|NCT01951469|"     This is a multi-center phase II randomized controlled study to assess the efficacy of     Gefitinib alone and Gefitinib combinating with Pemetrexed/cisplatin on patients with brain     metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by     intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.   "
101966|NCT01951456|"     The purpose of this study is to determine whether resistance training can aid smoking     cessation.   "
102820|NCT01940315|"     This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter     investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.   "
101969|NCT01951417|"     This is an open-label, multi-center study to be conducted in the United States. The study     will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in     conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once     daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for     treatment with Epiduo® in accordance with the currently approved product labeling and who     meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study     products for 8 weeks. Efficacy and safety assessments include: complete lesion counts,     cutaneous irritation assessment, end of study treatment questionnaire, photographic     evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function     assessment, treatment compliance, and adverse event assessment.   "
101970|NCT01951404|"     Kidney patients on dialysis commonly die because of heart disease. One of the biggest     problems in their hearts is that the muscle wall of the heart thickens. This makes it less     efficient. We found in patients with mild kidney disease that a drug normally used to treat     gout (allopurinol) had the remarkable side effect of being able to reduce this thickening of     their heart wall. In this new study we aim to find out if this benefit of allopurinol also     occurs in severe kidney patients i.e. those on regular dialysis. We also are trying to figure     out the best dose of allopurinol to use. To do this we are planning a study where we will     recruit patients with kidney disease who are on dialysis. The 1st phase of the trial will be     to determine the best dose of allopurinol to use and the second phase will be to do a     clinical trial where patients will be randomly allocated to either this optimum dose of     allopurinol or a dummy medication (placebo) and will receive one year of treatment. They will     have a special scan of the heart using an MRI machine to measure the extent of thickening of     their heart muscle before they start on treatment and will have a further MRI scan when their     one year treatment finishes.      Phase 1- the dose finding study, will involve 10 patients who will have between 3 and 7     visits to the hospital scheduled around 4 to 17 dialysis sessions. The later study will     involve up to 76 patients who will be asked to attend the hospital up to 8 times over a 13     month period.   "
101971|NCT01951391|"     Up to 20 volunteers will be recruited to evaluate the microbial environment on their     forearms. Following informed consent, bacterial swabs will be obtained on day 0 from the     forearms of all subjects. Their forearms will then be washed with one of the study cleansers.     Subjects will then be instructed to return at different timepoints over the next several days     for repeat bacterial swabbing of their forearms. For the first 10 participants, these     timepoints will be every 24 hours for a total of 3 days. For the following participants,     these timepoints will be at 10 minutes, 6 hours, and 24 hours after the wash. DNA will be     extracted from all swabs and bacterial diversity evaluated by 16S pyrosequencing.   "
101973|NCT01951365|"     Spinal intradural schwannoma detected incidentally increased recently. Because there is     little knowledge about natural history of spinal schwannoma, there is no consensus of     treatment. Our hypothesis is as follows;        1. Some schwannomas keep growing, the others do not.        2. Foraminal schwannomas do not usually grow.      The investigators analyzed natural history and characteristics of 56 spinal schwannomas     observed initially with accurate and reliable methods. Here the investigators displayed     growing pattern and differential point of spinal schwannoma.   "
101974|NCT01951352|"     In this study we will test the ability of different commercially available hand soaps to     effect the amount of anti-microbial peptides present on the surface of the human skin after     washing with these soaps. Based on our experiments on pig skin, we expect the amount of     antimicrobial peptide expression to decrease after using these different soaps.   "
101977|NCT01951313|"     The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and     vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of     fruits and vegetables results in limited availability of certain nutrients found in these     foods such as carotenoids. Dietary carotenoids have health beneficial properties and are     known to fight against disease. Eggs are known to be a good source of carotenoids and eggs     may improve the absorption of carotenoids found in co-consumed fruits and vegetables.     Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will     increase carotenoid absorption.   "
101978|NCT01951300|"     This study investigates whole-body distribution kinetics of intravenously administered     Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT).     Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.   "
101979|NCT01951287|"     Blood sugar and insulin levels after a meal may be altered by the food and beverages a person     consumes. Keeping a healthy blood sugar level may help prevent and manage type 2 diabetes and     related diseases. This study will look at how drinking different common beverages (milk,     low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal changes blood sugar     and insulin levels.   "
101980|NCT01951274|"     A study of a several doses of a novel treatment for chronic itch compared to placebo for     patients whose condition has not responded to other treatments   "
101981|NCT01951261|"     To determine if an early assisted discharge program for acute exacerbations of COPD (AECOPD),     with telemonitoring and telephone control, is equally effective and more efficient in terms     of use of health care resources, that a home care provided by hospital respiratory nurses and     pulmonologists.   "
101982|NCT01951248|"     The purpose of this study is to investigate the effect of 3 months of continuous positive     airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases     in patients with chronic kidney disease. The effect is evaluated on blood pressure levels,     particularly nocturnal blood pressure, both central and peripheral, and renal function,     including the kidneys treatment of salt and water.      Hypothesis:        1. Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during          the day more accurately than peripheral 24-h blood pressure measuring because the          measurement is painless and does not interfere with the patient activities during the          daytime or nighttime sleep.        2. Central blood pressure is elevated in patients with OSA and falls during treatment with          CPAP.        3. The renal tubular function relating to the treatment of water and sodium is abnormal in          patients with OSA with increased tubular absorption of water via the U-aquaporin 2          (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during          treatment with CPAP.      4 Quality of life is improved during treatment with CPAP.   "
101984|NCT01951222|"     Recent large clinical studies have demonstrated the interest of LAMA therapy in the     management of asthma, when compared to LABA.      V0162 is a compound with a very long lasting bronchodilator effect when compared to reference     treatment in non-clinical models and in COPD patients. Secondary properties of V0162     (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound     and could bring option in the treatment obstructive lung disease. The objective of the study     is to assess the bronchodilator properties of V0162 during 8 days in adult patients with     asthma usually treated with ICS and LABA. The study is a randomised, double-blind,     placebo-controlled, 3-period crossover, preceded by an open-label active-control period     before randomisation.   "
101997|NCT01951040|"     This study was designed as a retrospective cohort study where patients given synthetic     oxytocin during labor induction were considered as the exposed cohort, and patients not given     oxytocin formed the non-exposed cohort. Four hundred of the 7465 children born at our     maternity during 2006 were randomly selected. Information about breast-feeding was available     for 316 of these children. Eventual confounding or adjustment factors were analyzed using     stratified and multivariate analysis (logistic regression   "
101985|NCT01951209|"     Hepatitis C is the leading cause of chronic liver disease and cirrhosis in United States     veterans. Cirrhosis is associated with impaired antibody responses and increased risk of     bacterial infections. We have recently identified that cirrhosis is associated with     abnormalities of memory B-cells, cells that make antibodies and help protect against     bacterial infections. We have identified that chemicals associated with gut bacteria might     play a role in causing these B-cell abnormalities. It is well known that gut bacteria have     increased access to the blood in individuals with cirrhosis, a process called bacterial     translocation. We hypothesize that reducing bacteria counts in the gut by using     poorly-absorbed antibiotics (also known as selective gut decontamination) will partially     reverse losses of memory B-cells in cirrhosis by reducing bacterial translocation.   "
101986|NCT01951196|"     A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of     fall in blood pressure during nighttime) is a strong predictor for the risk of cardiovascular     disease and mortality in patients with hypertension. Three factors seem to affect the night     time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA) or the way     ambulatory blood pressure is monitored.      The aim of this study is to analyse the importance of these three factors on nighttime     bloodpressure.      Hypothesis:      Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in     blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is     painless and does not interfere with activities during the daytime or night-time sleep      In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy     subjects.      In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the     severity of OSA, the severity of kidney disease, and blood pressure during daytime.   "
101987|NCT01951183|"     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will     evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients     treated with a stable dose of metformin.   "
101988|NCT01951170|"     This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in     patients with active moderate to severe rheumatoid arthritis. Participants will receive a     subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment     is 24 weeks.   "
101989|NCT01951157|"     A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in     comparison to docetaxel for the treatment of unresectable non-small cell lung cancer     (NSCLC)patients   "
101990|NCT01951144|"     The purpose of this study in healthy people is to evaluate safety, toleration and time course     of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of     PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865     administered as a tablet formulation may also be investigated. Pharmacodynamic interaction     between PF-06372865 and lorazepam will be evaluated.   "
101991|NCT01951118|"     Olfactory identification deficits occur in patients with Alzheimer's disease (AD), are     associated with disease severity, predict conversion from mild cognitive impairment (MCI) to     AD and are associated with healthy elderly subjects developing MCI. Odor (olfactory)     identification deficits may reflect degeneration of cholinergic inputs to the olfactory bulb     and other olfactory brain regions. Acetylcholinesterase inhibitors (ACheI) like donepezil     show modest effects in improving cognition but can be associated with adverse effects and     increased burden and costs because of the need for prolonged, often lifelong, treatment.     Converging findings on odor identification test performance (UPSIT, scratch and sniff 40-item     test) from four pilot studies, including two of our own, suggest that acute change in the     UPSIT in response to an anticholinergic challenge (atropine nasal spray), incremental change     over 8 weeks, and even the baseline UPSIT score by itself, may predict cognitive improvement     with ACheI treatment in MCI and AD. If change in odor identification deficits can help to     identify which patients should receive ACheI treatment, this simple inexpensive approach will     advance the goal of improving personalized treatment, improve selection and monitoring of     patients for ACheI treatment, reduce needless ACheI exposure with risk of side effects, and     decrease health care costs.   "
101992|NCT01951105|"     This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in     individuals with sub-acute back pain (SBP) is associated with changes in blocking transition     to chronic back pain (CBP).   "
102016|NCT01950793|"     The study is to compare the effect between steroid injection and Hyaluronic acid in treatment     trigger finger. Using sonoguided injection technique achieves more accurate injection     location and therapeutic effect. We hypothesize hyaluronic acid has both lubricant and     anti-inflammation effect in treatment of trigger finger, and can provide better outcome and     lower adverse effect than steroid injection.   "
102097|NCT01949896|"     Prior to a non-urgent blood transfusion, subjects will be randomized to either stopping feeds     or continuing feeds. The intervention group will be the placement of a subject in the NPO     group. Subjects in the intervention group will have their feedings stopped for a total of 24     hours around the time of the PRBC transfusion. These infants will be given intravenous     nutrition during the period of time that they will not be fed. During the transfusion, both     groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours     pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.   "
101993|NCT01951092|"     Despite advances in antiretroviral treatment (ART) over the past 10 years, the incidence of     HIV in the United States remains stagnant with over 50,000 new cases annually. HIV-infected     individuals inconsistently engaged with care are less likely to receive ART which is     associated with correspondingly adverse clinical outcomes in the long term and increased risk     of transmission. Mobile health (mHealth) strategies including cell phone and text messaging     have shown success in the developing world for medication adherence, yet mHealth     interventions have not been developed to improve retention in HIV care. This strategy needs     to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in     supporting HIV treatment adherence in Rhode Island.      The Miriam Hospital Immunology Center is an urban HIV-clinic that provides comprehensive     primary and specialty care for over 1400 HIV-infected patients. It is the largest HIV clinic     in Rhode Island with patients also referred from eastern Connecticut and southern     Massachusetts. In 2010, there were 165 new patients in clinic, 70 of whom were diagnosed     within 1 year of entering care. In this environment, we propose a pilot study with the     following specific aims:      Specific Aim 1: To pilot a bidirectional mHealth intervention among individuals at high risk     of loss to follow-up, including those with a recent HIV diagnosis or those re-engaging in HIV     care. HIV-infected persons (n=30) with a recent diagnosis or re-engaging in care at the     Immunology Center at TMH will be recruited to participate in a bidirectional mHealth     intervention that delivers automated, regularly scheduled appointment and medication     adherence reminders in an individualized format, and also allows individuals to request     motivational enhancement and problem-solving support to address barriers to care.      Specific Aim 2: To assess the impact and acceptability of the pilot intervention through     qualitative interviews. All participants will also be invited to complete individual in-depth     interviews which will assess acceptability and effectiveness of the pilot mHealth     intervention, such as content and frequency of automatic messages, for retention and     medication adherence for HIV-infected individuals in RI.      The results of this study will provide preliminary data to inform an R21 or R34 application     to determine efficacy of an mHealth intervention among HIV-infected persons at high-risk for     loss to follow-up.   "
101994|NCT01951079|"     In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac     Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in     doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this     study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up     to 30 weeks pregnancy .   "
101995|NCT01951066|"     To measure various pro-permeability factors in the aqueous humor of patients with     persistent/recurrent diabetic macular edema   "
101996|NCT01951053|"     The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement     sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the     study medication) of JNJ-40411813.   "
101999|NCT01951014|"     Currently little is known about the health beliefs and behaviors of pregnant adolescents. The     goal of this pilot study is to educate pregnant adolescents via social media about nutrition     and fitness during pregnancy and to evaluate their health beliefs and behaviors before and     after receiving this information. Data collected will provide new information on which to     base subsequent research and can be used to inform nutritional guidelines or public health     programming for this vulnerable age group.   "
102000|NCT01951001|"     The purpose of this study is to determine whether the fixed-dose (prasugrel 10 mg/d vs. 5     mg/d) vs. phenotype (platlet function test by VerifyNow P2Y12 assay)-based prasugrel dose     adjustment can match therapeutic zone of platelet reactivity in PCI-treated Asians with acute     coronary syndrome   "
102001|NCT01950988|"     The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl®     toothbrush as compared with a standard  soft  manual toothbrush ADA (American Dental     Association) reference using the modified Stillman brushing technique, in children, adults     and elderly persons, after 3 months of daily use.   "
102002|NCT01950975|"     The principal result expected is the discovery of inframicroscopic chromosomal rearrangements     in regions of the genome not yet known to be involved, or mutations in known candidate genes;      The identification of such a mosaic rearrangement in an affected infant would lead to     improved genetic counselling. Indeed, as this mosaicism is a consequence of a genetic event     occurring at an early stage of embryogenesis, it would be possible to confirm the sporadic     nature of the observed disorder and therefore to predict a very low or even negligible risk     of recurrence for the couple concerned. For the affected infant, the risk for his/her own     offspring will be assessed according to the nature of the genetic anomaly discovered. For     medical practice, investigators hope that this study will lead to a clearer definition of the     screening modalities for mosaicism in the disorders concerned. In particular, they hope to     determine whether or not it is possible to dispense with a skin biopsy, which is more     invasive than a blood sample.   "
102003|NCT01950962|"     This is a transversal double-centre study. Patients will be recruited from outpatient     consultations. They will have buccal inflammation caused by periodontal disease (frequent     oral infections, mostly with GRAM (-) bacteria). Three groups of 80 patients, corresponding     to slight, moderate and severe periodontal disease, will be formed according to the results     of radiological and clinical examinations.   "
102004|NCT01950949|"     Mesquida, J et al showed there was a significant linear correlation between pulse pressure     variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase     of severe sepsis and septic shock. No study revealed the actual relationship between various     PPV under different VT. So we hypothesized that there were relationship between various PPV     in different tidal volume settings. The objective of this study was to examine the     relationship between various PPV.   "
102005|NCT01950936|"     Title: Pro-to-COLD, Procalcitonin to Chronic Obstructive Lung Disease,      COLD: Chronic Obstructive Lung Disease, Regarding: Patients hospitalized with suspected acute     exacerbation of COPD + / - pneumonia.      Background: Patients with COPD exacerbation often get antibiotics. There is considerable     criticism of this, many of these patients are not bacterially infected and the antibiotics     overconsumption can lead to resistance development and side effects.      The purpose: To show that one can reduce the consumption of antibiotics among patients     hospitalized for worsening of COPD disease in a population of Danish COPD patients by giving     antibiotics depending on the value of the biomarker procalcitonin measured in the blood. A     sub-objective is a validation study of mini VIDAS ® / Biomérieux equipment to the current     gold standard in measuring procalcitonin, Kryptor/ BRAHMS.      Subjects: All patients with confirmed/suspected COPD admitted with COPD exacerbation to the     Acute Admissions Unit/ Pulmonary dept. in weekdays. Participants must be adults and be of age     and there must be a signed informed consent.      Method: 1) Controlled (Quasi-randomized): Even and uneven (concealed) digit of patient´s     danish personal identification number, not last digit (gender-fixed) (CPR-number). Even =     procalcitonin-guided, Uneven = Control.      2) Collect and analyze procalcitonin (PCT)-samples of patients in the PCT group at admission     and then every 2 day. Samples analyzed throughout the week: Vital Status looked up 28 days     after inclusion. Create a biobank in the study consisting of blood à 8 ml up to a maximum of     4 times taken for PCT measurements, the subsequent validation study of MiniVIDAS ®. Biobank     destroyed 15 years after the completed project.      Statistical considerations:        1. Sample size / Sample Size:           A total of 120 patients (please see the basis for this estimate of the Protocol).        2. Analyze:      A) Antibiotics stopped on day 5 B) Defined Daily Doses Reads aloud, 1) narrow spectrum, 2)     broad spectrum, and 3) a total of the two groups between the (Mann-Whitney U test) C)     Hospitalization within 28 days after the first hospitalization the year - the two groups     between (Mann-Whitney U test). Doctor Jens-Ulrik Jensen stands for analyzes. Statistics     program SAS v. 9.1.3 is used.      Economics: The study funded by the participating departments.      Responsibility: The study was conceived and run by doctors in Pulmonary Medicine Department     and Department of Clinical Pharmacology, both Bispebjerg Hospital and Department of Clinical     Microbiology, Hvidovre Hospital.      Science Ethics: There has been a thorough research ethics discussion of the project in the     project with emphasis on an assessment of the advantages and disadvantages that might be for     the participating patients and society as a whole now and in the future. Conclusions A and B     of this discussion is summarized as:      A. Advantages and Disadvantages: The treating physician has at any time the opportunity to     start / continue antibiotic behandlling for the overall assessment whether PCT value. In     addition, in the past, in large studies with a total of> 2000 patients, demonstrated that     there are drawbacks to the use of antibiotics depending on a displayed value of PCT in     patients hospitalized with acute exacerbations of COPD. Mortality and hospitalization will be     monitored in this study. However, there may occur side effects to blood sampling, usually     transient ecchymosis blood sampling site. If the strategy results in a reduced consumption of     antibiotics, it is expected that the incidence of antibiotic-associated adverse events     decreased - this for the benefit of the patient.      B. Usefulness for society: Based on the results from this study will be a high degree of     certainty to conclude whether this new treatment strategy can provide benefits for future     patients in the form of reduced antibiotic consumption, less antibiotic associated adverse     events, reduced resistance development / selection among bacteria and overall lower economic     costs. Based on these considerations, believes the project, the project can be carried out     with respect for the participating subjects to integrity.      Quantity: It is expected to be included 120 patients in this scientific study. Database: data     (case report forms) stored in archive of Pulmonary Medicine Department for 15 years. Create a     database with the information. Personally identifiable data will only be present in the     clinical hospital. During the completion of the experiment can provide essential health     information about the subject's state of health. This will the subject be informed, unless     clearly opted out of this on the consent form. The project reported to the Data Protection     Agency.      Level: With blood sample (8 mL) on day 1 and then every 2 days in the intervention group (the     active group), this part of routine blood sampling. At discharge stops blood and the     patient should not attend the blood after discharge.   "
102006|NCT01950923|"     This randomized pilot clinical trial studies sildenafil citrate before surgery in improving     kidney function in patients with kidney cancer. Sildenafil citrate may help protect the     kidney from the side effects of surgery and improve kidney function after surgery.   "
102041|NCT01950624|"     Objective: The development of a patient registry for Down syndrome (DS) was identified as a     priority in the 2007 Down Syndrome Research Plan. Under the auspices of the Down Syndrome     Consortium, founded in 2011 as a public-private partnership between the NIH and DS advocacy     organizations, NICHD awarded a contract in 2012 to create a patient-focused online registry     to facilitate research participation by individuals with DS. Two advisory boards, composed of     advocates, family members, clinicians, researchers, and other relevant parties, have been     involved in the development of the registry materials.      Study Population: Individuals with DS (including those with mosaic DS and partial trisomy 21)      Design: DS-Connect (TM) is an online survey tool designed to collect demographic data and     health information from individuals with DS.      Outcome measures: The purposes of DS-Connect (TM) are:        1. To identify the various phenotypic manifestations of DS.        2. To identify individuals with DS who may be eligible for research studies or new clinical          trials, based on specific information about their diagnosis and health history.   "
102007|NCT01950910|"     Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive     degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early     diagnostic test for ALS, making identification of the disease difficult at its earliest     stages. Early detection is critical to the initiation of early neuroprotective therapy. By     the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has     already occurred. The purpose of the current project is to establish a bank of blood samples     (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early     diagnostic test for ALS and for better understanding the progression of this disease. The     main idea of the current study is to examine samples from patients that have a suspected     diagnosis of motor neuron disease, including patients with ALS who have not progressed far     enough to be definitively diagnosed as having ALS. Normal and disease control samples will be     collected for comparison. The investigators will examine various biochemical and metabolic     markers from these samples, in hopes of finding differences in their expression between     control subjects and ALS patients and during disease progression. Ultimately, the     investigators would like to have a panel of markers from the blood that would allow us to     diagnose and follow the progression of ALS from the earliest possible moment. The data     collected from this project would give us a basis for a fairly non-invasive, quick and     clinically relevant test for the early diagnosis of ALS. This in turn would allow us to     provide earlier intervention for these patients, possibly slowing the damage and improving     prognosis.   "
102008|NCT01950897|"     Muscular dystrophies are caused by mutations in more than 30 genes, some of them remaining to     be identified. Phenotypically, it is known that one specific mutation can affect the     expression of several other proteins, causing difficulty in diagnosis. Correct genotyping is     essential for diagnosis, prognosis and treatment, and relies on a complexed analysis of     muscle tissues for phenotype profiles. Our research aims to understand how different gene     mutations affect expression of other genes via muscle biopsy samples and establishment of     phenotypic profiles for correct diagnosis of individual patients. Establishment of such     information will be critical for understanding the progression of different muscular     dystrophies and to devise new experimental therapies. The research will also provide vital     clues for finding new genes involved in the disease process. Muscle samples may also be used     to establish cell cultures for testing drugs and new therapies relevant to the treatment of     the muscular dystrophies.   "
102009|NCT01950884|"     -  NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver          disease in Western countries (hepatic manifestation of insulin resistance);        -  NAFLD represents a cardiovascular risk factor;        -  Lifestyle modification(weight loss)is the effective medical treatment recommended for          NASH (Non-alcoholic Steatohepatitis);        -  Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the          investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive          effect of ezetimibe on liver histology, biochemical and sonographic parameters in a          small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs          lifestyle+ezetimibe.   "
114582|NCT01786044|"     The purpose of this study is to assess the effects of an interactive educational program     delivered through a patient portal on patients' medication knowledge and medication     adherence.   "
102010|NCT01950871|"     The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS)     analysis can be used to improve the detection of clinically significant prostate cancer     (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice.     Prostate HS is an ultrasound-based tissue characterization technology specifically developed     to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues     are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has     been developed that uses the results of the prostate HS analysis.      The subjects that will participate in this study are all scheduled for a first biopsy of the     prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data     for prostate HS analysis. The results of HS analysis will be used later in the procedure.     Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS.     This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis     and new biopsy guidance tool.   "
102011|NCT01950858|"     safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous     osteonecrosis of the knee   "
102012|NCT01950845|"     Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of     fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume     optimization have been shown to improve patient outcomes, especially for moderate and high     risk abdominal surgical patients. A novel closed-loop fluid administration system based on     multi-parameter hemodynamic monitoring have been described recently. This prospective,     randomized, surgeon and patient blinded study aims at comparing the cardiac output provided     by either this closed-loop system or the anesthesiologist team in high-rish surgical patient     elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon,     France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will     also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart     rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of     stay) between groups   "
102013|NCT01950832|"     To evaluate the macular, retinal nerve fiber layer (RNFL) and choroidal thickness alterations     by using spectral-domain optical coherence tomography (SD-OCT) in polycystic ovary syndrome     (PCOS) and to compare them with healthy reproductive-age women controls.   "
102014|NCT01950819|"     This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft     function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal     transplant recipients.   "
102015|NCT01950806|"     The objective of this randomized, controlled feeding study is to investigate the potential     health benefits of a pecan-containing diet. The investigators hypothesize the chronic     consumption of pecans will improve an array of biomarkers related to cardiovascular disease     and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity,     inflammation, endothelial function, and insulin resistance when compared with a control diet     that is absent nuts.   "
102972|NCT01938313|"     Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of     reducing the surgical stress response and obtaining optimal recovery after surgery.   "
102017|NCT01950780|"     Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune     disease. In the disease, the immune system mistakenly destroys the hair follicle, causing     hair to fall out. Despite many people having this disease, research into its cause and into     new, better ways to treat AA has lagged far behind other similar diseases of the immune     system. Currently, there are no Federal Drug Administration approved drugs for AA.      Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the     bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid     arthritis, another autoimmune disease, by fighting inflammation. There are some genetic and     chemical similarities between those with myelofibrosis, active rheumatoid arthritis and AA,     suggesting that treatment with ruxolitinib may be effective in AA. In mice specially designed     for testing drugs for the treatment of human alopecia areata, this medication worked to     prevent the disease AA from starting in mice that would have otherwise developed the disease.     To test Ruxolitinib, we are going to treat 12 patients with moderate to severe AA for a     minimum of 3 months up to 6 months. This is an open-label study, meaning that there will     not be a placebo group; all patients enrolled in the study will receive the active     medication. The effectiveness of the medication will be measured by changes in hair re-growth     as determined by physical exam and photography, as well as by patient and physician scoring.     Patients will be followed for another 3 months off of the drug to see if the effects of     treatment last and if there is delayed response. The safety of the medication, ruxolitinib,     in patients with alopecia areata will also be evaluated.      Blood work will be collected before medication is started, during the treatment period, and     after ruxolitinib is stopped, in order to monitor for adverse effects of the medication.     Small scalp biopsies and peripheral blood will be taken at the beginning of the study before     treatment and also after 12 and possibly 24 weeks. Optional biopsies may also be taken at     additional time points based on clinical considerations. The chemical analysis of these skin     samples and blood will help us to understand how the disease happens, how the treatment     works, and may even guide us to better treatments in the future.   "
102018|NCT01948739|"     The purpose of this study is:        1. To augment the MAHI Exo-II, a physical human exoskeleton, with a non-invasive brain          machine interface (BMI) to actively include patient in the control loop and thereby          making the therapy 'active'.        2. To determine appropriate robotic (kinematic data acquired through sensors on robotic          device ) and electrophysiological ( electroencephalography- EEG based) measures of arm          motor impairment and recovery after stroke.        3. To demonstrate that the BMI controlled MAHI Exo-II robotic arm training is feasible and          effective in improving arm motor functions in sub-acute and chronic stroke population.   "
102019|NCT01948726|"     Hypofractionation with simultaneous integrated boost has been investigated in a few trials     and appears to be safe and feasible with less lung toxicity in smaller studies.      Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity     of hypofractionation with simultaneous integrated boost in patients with early breast cancer     under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II     according NCI-CTCAE amounts maximum 20%.   "
102034|NCT01950715|"     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood     but recent studies have shown changes in both colonic motility and rectal sensibility. The     investigators have previously shown IBS patients to benefit from sacral nerves stimulation.     With the present study, the investigators aim to evaluate if sacral nerve stimulation alters     the gastro-colic response in IBS patients.   "
102035|NCT01950702|"     To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.   "
102020|NCT01948713|"     INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined     as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology     causes physical discomfort and impacts the quality of life in a negative manner.     Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can     be applied with focus on strengthening the pelvic floor muscles or on muscular synergism.     OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in     association with the strengthening of the muscles of the hip in the treatment of stress     urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It aims     at assessing objectively the strength of the pelvic floor, the improvement in the number of     episodes of loss and impact on quality of life. The study will accept up to 40 women, who     will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic     floor muscles with Kegel exercises) and group 2 (that will perform strengthening the pelvic     floor muscles with Kegel exercises associated with the strengthening of muscles of the hip).     The two groups will be evaluated at the beginning and at the end of treatment.   "
102021|NCT01948700|"     Hispanic adolescents experience more severe alcohol-related consequences due to their alcohol     abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment,     particularly among justice-involved youth. Despite the level of research that has been     conducted on motivational interviewing (MI) with mainstream samples, no published studies     have investigated the efficacy of this brief, individual intervention with Hispanic     adolescents. The overarching objective of this application is to evaluate the efficacy of a     brief individual intervention (MI) for problem drinking behaviors with a sample of     justice-involved Hispanic and Caucasian adolescents to determine if this intervention is     differentially effective between Hispanic and Caucasian adolescents. Specifically, the first     aim is to determine whether an MI intervention targeting alcohol abuse is effective at     reducing alcohol use and related risk behavior in a sample of adolescent alcohol abusers. The     second aim is to examine whether the effects of MI on problem drinking outcomes (e.g.,     alcohol problems, quantity of drinking, frequency of binging) are different between Hispanic     versus Caucasian adolescents. Because it is important to determine the mechanisms that     mediate the effects of MI and determine whether these mechanisms differ between Caucasian and     Hispanic adolescents, the third aim is to examine whether group (Hispanic vs. Caucasian)     moderates the mediational linkages in the overall model using a cross-groups approach to     moderated mediation. To accomplish these aims, 453 Caucasian and Hispanic justice-involved     alcohol abusing adolescents (ages 14-17) will be randomized to either two 60 minute MI     interventions (one at baseline and a second, one week later) or an education condition. All     adolescents will receive behavioral assessments at baseline, 3, 6 and 12 months. The proposed     research is expected to take a significant step towards reducing current racial/ethnic health     disparities in alcohol treatment for Hispanic adolescents.   "
102022|NCT01948687|"     AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in     noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis   "
102023|NCT01948674|"     The purpose of this study is to see if computer tasks that challenge the brain (cognitively     stimulating tasks) can improve memory and other types of thinking in adolescents and young     adults who are being treated for substance use problems. The study will compare the effects     of different versions of the computer tasks.   "
102048|NCT01950533|"     Food allergy is on the rise within the pediatric population. Having food allergy can cause     medical, nutritional and psychological issues in those who suffer with it. Although making     the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy     has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give     positive results that are false. Currently, Oral Food Challenges are the best way to diagnose     a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily     available to suspected food allergy sufferers. This study is designed to examine the     effectiveness of an allergy-detecting blood test called IMMULITE 2000 manufactured by the     study sponsor, Siemens.   "
106926|NCT01886482|"     The investigators aimed to determine the effects of HP diet on CVD risk factors among     overweight and obese children.   "
102024|NCT01948661|"     Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for     testing agents with potential cancer prevention.      Meriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric     (Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In vivo     data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood levels     of parent agent than natural curcumin.      Mirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside     (C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the     Apc(Min) mouse model.      The investigators hypothesize that the combination of both agents will decrease the     expression of proteins involved in colon tumorigenesis relative to placebo.      The change of biomarker expression between pre-treatment biopsy and post-treatment endoscopic     resection in the target adenoma and the normal rectal mucosa will be the response measures.      The primary response measure is the change of immunohistochemical (IHC) expression of     β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are the     changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and     apoptosis by P53 in adenomatous and adjacent normal mucosa.      The study design is a phase II, randomized, double blind, placebo controlled, window of     opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo.     Subjects with histological confirmation of colorectal adenomatous polyps >1 cm not suitable     to immediate complete removal will be enrolled in a 4-week intervention trial before     endoscopic polypectomy.      The demonstration of a biological activity of the two agent combination may provide the     rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk     subjects.   "
102025|NCT01948648|"     If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further     reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that     treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma     concentrations of sitosterol and other plant sterols in sitosterolemia patients.   "
102026|NCT01948635|"     The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce     microaspiration of gastric content as determined by pepsin level in tracheal aspirate.   "
102027|NCT01948622|"     This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in     patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.   "
102028|NCT01948609|"     PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations     who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical     management. The investigators will compare the change in cardiovascular health, bone health,     sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between     women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not     undergo RRSO.      The investigators hypothesis is that women who undergo a premature surgical menopause induced     by RRSO have worse cardiovascular health and bone health compared with women who do not     undergo RRSO.   "
102029|NCT01948596|"     The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty     acids for pregnant women with depressive symptoms.   "
102030|NCT01948583|"     Aim of the study is to evaluate the humectant activity and the local tolerability of a new     formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years)     with referred vaginal dryness   "
102031|NCT01950754|"     This study could contribute to understanding the aggravation of balance disorders and the     increased risk of falling in depressive people. It could, among other things, shed light on     the impact of treatments with antidepressants on balance in treated depressive patients.     Finally, it could contribute to improving the sensory-motor management of patients with a     depressive syndrome.   "
102032|NCT01950741|"     Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy     (PCV) will be evaluated.   "
102033|NCT01950728|"     The objective of this study is to compare the hypoalgesic effects of TENS, Interferential     current and Aussie current in pressure pain threshold and sensory discomfort in healthy     subjects.   "
114583|NCT01786031|"     Toward personalised treatment in early metastatic prostate cancer based on the assessment of     biomarkers in cancer tissue samples and circulating tumour cells.   "
102037|NCT01950676|"     The primary aim of this study is to investigate the feasibility of using a patient-centered     smart phone application for insulin self-titration on glycemic control. Over a 18-month     period, suboptimally controlled type 2 diabetes mellitus (T2DM) on oral antidiabetic agents,     thus requiring insulin treatment patients, will be recruited from the Singapore General     Hospital (SGH). Patients randomized to the intervention group will be instructed to     self-adjust their insulin dose using a smart phone application designed to guide     self-titration; patients randomized to the control group will receive the usual clinical     care. The primary outcome measure is change in glycated hemoglobin level (HbA1c), 6 months     post-enrollment. The investigators hypothesize that using a smart phone application for     insulin self-titration is effective in improving glycemic control in T2DM patients compared     with usual care.   "
102038|NCT01950663|"     RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy.     The purpose of this study is to calibrate RETeval, and then measure its ability to detect     vision threatening diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS)     7-field, dilated, stereo, color fundus photography, read according to the ETDRS protocol,     will be used as the gold standard.   "
102039|NCT01950650|"     This study is conducted in Asia, Europe and in the United States of America. The aim of this     study is to examine patient and physician beliefs regarding insulin therapy and the degree to     which patients adhere to their insulin regimens.   "
102040|NCT01950637|"     This study is conducted Asia, Europe and North America. The aim of this study is to describe     insulin therapy adherence and the burden of non-adherence on patient functioning, well-being     and diabetes management.   "
102070|NCT01950247|"     The main objective of this study is to compare the safety, effect on quality of life, and     resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the     treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also     assess the ability of baseline serum hepcidin levels to predict if subjects will have a     clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.   "
102071|NCT01950234|"     This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to     evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar     gel) administered as a pulsed regimen consisting of injections on three consecutive days per     month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be     randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1)     pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of     clinical and paraclinical measures of MS progression compared to placebo.   "
102042|NCT01950611|"     The clinical outcome of relapsed acute promyelocytic leukemia (APL) is poor with current     standard of care approaches. Additionally, standard of care warrants an autologous stem cell     transplant to be done once molecular remission is achieved. Unfortunately, the majority of     our patients cannot afford this procedure. We have previously reported the clinical outcome     of relapsed patients who were managed without a stem cell transplants and showed that the     event free survival at 5 years is less than 35%. Pre-clinical data reported from our     laboratory demonstrates that there is significant synergy between arsenic trioxide (ATO;     which is the accepted standard of care agent for relapsed APL) and Bortezomib (a proteasome     inhibitor). We have evaluated this combination extensively in-vitro and this data was     accepted as an oral presentation at the American Society of Hematology (ASH) meeting in 2011.     More recently we have also reported the potential mechanism for this synergy (Poster at ASH     2012). We also have mouse model data which supports these findings. We plan to move this     combination of ATO based therapy combined with Bortezomib to a Phase II clinical trial to     validate these observations. The anticipated potential is that we will have a combination     therapy that is less expensive, cost effective and safe with comparable clinical outcomes to     those treated with the more expensive standard of care which includes an autologous stem cell     transplant and which the majority of our patients cannot afford.   "
102043|NCT01950598|"     The purpose of this study is to determine whether frozen corneas are as safe and effective as     fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over long     term follow-up.      Corneal transplantation is typically performed using fresh, transparent corneas. With KPro     surgery, the corneal transplant only serves as a carrier to suture the KPro in place. The     cornea used in KPro surgery does not need to be clear like a normal transplant. Frozen     corneal tissue can be used to repair the cornea in cases of emergency but the tissue is not     transparent and does not allow good vision. We hypothesize that frozen grafts are equivalent     as fresh grafts when used as carrier for the KPro.   "
102044|NCT01950585|"     Pulmonary arterial hypertension (PAH) is a serious and eventually fatal disease damaging the     lungs and the heart. It results from narrowing and eventual blockage of small blood vessels     in the lung, due to abnormal proliferation of cells in the blood vessel (arterial). Patients     with PAH suffer from fatigue, shortness of breath, low oxygen levels, blood clots and heart     failure. No therapies reverse the disease process in the lung arteries, however there are     three approved drugs that can temporarily dilate the vessels and improve symptoms. However,     all three drugs have significant side effects and toxicities, they do not work effectively in     many patients, survival remains on average only 2 to 3 years once symptoms begin, and none of     these drugs prevent the underlying disease process in the small arteries of the lung.      PAH is known to develop in patients with a pre-existing class of bone marrow diseases called     myeloproliferative disorders (MPDs). We and others have recently shown that patients with PAH     have bone marrow changes similar to those seen in patients with MPDs, even without other     signs and symptoms of those bone marrow diseases such as anemia or high platelet and white     blood cell counts. Compared to healthy volunteers, patients with PAH have a higher frequency     of immature stem and progenitor cells able to produce blood cells and vascular wall cells in     their bone marrow. They also have higher circulating numbers of these cells in the blood, and     increased localization of these cells in the lung blood vessels. When immature bone marrow     cells from PAH patients and normal volunteers were infused into mice, the mice receiving PAH     marrow cells developed similar lung and heart problems to PAH patients, suggesting that the     bone marrow problem is a primary cause of the lung problems, and that the increased numbers     of immature bone marrow cells in the bone marrow and blood of PAH patients causes the lung     blood vessel disease.      The drug hydroxyurea is used to inhibit the abnormally high level of bone marrow cell     proliferation in patients with MPDs. It has been shown to reduce the numbers of circulating     immature bone marrow cells in patients with MPDs. Hydroxyurea has been available for almost     fifty years, and has been used to treat patients with MPDs, sickle cell anemia, and     congenital heart disease for very prolonged periods of time, up to twenty or more years in     individual patients. It has an excellent long-term safety profile and few side effects and is     generally well tolerated. It does not appear to result in an increased rate of leukemia even     with many years of treatment.      In the current protocol, we hypothesize that treating patients with PAH with hydroxyurea will     decrease the level of circulating immature bone marrow cells and interrupt the abnormal     narrowing and occlusion of lung arteries. We will treat patients with moderately severe     primary (no known underlying cause) PAH with 6 months of hydroxyurea, carefully monitoring     side effects and adjusting dosage as necessary, and measure the effect on circulating     immature cells, lung blood vessel pressures, other blood markers of active PAH, and exercise     tolerance.   "
102845|NCT01939977|"     To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation     (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D     nutritional supplements (calcifediol) in patients with renal transplantation.   "
102045|NCT01950572|"     Background:        -  Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura,          peritoneum, pericardium, or tunica vaginalis.        -  Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant          pleural mesothelioma is the most common of these, comprising of 80% of the cases with an          annual incidence of about 2,500 in the United States.        -  The median survival from diagnosis of pleural mesothelioma is approximately 12 months.          The majority of patients present with stage III or IV disease with 85-90% of patients          considered unresectable at diagnosis.        -  Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless,          patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment          options due in large part to the rarity of the disease.      Objectives:      -To allow sample acquisition for use in the study of mesothelioma.      Eligibility:        -  All patients age greater than or equal to 2 years with malignant mesothelioma        -  Must be able and willing to provide informed consent if 18 or over; parent or guardian          must be able and willing to provide consent for patients under the age of 18      Design:        -  Up to 1000 subjects will be enrolled.        -  Patients will be followed to determine the course of disease and to record any treatment          received for mesothelioma.        -  Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for          tissue banking.        -  Studies which may be performed on banked material include genetic and genomic studies,          establishment of cell cultures and immunologic studies.   "
102046|NCT01950559|"     Food allergy is on the rise within the pediatric population. Having a food allergy can cause     medical, nutritional and psychological issues in those who suffer with it. Although making     the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy     has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give     positive results that are false. Currently, Oral Food Challenges are the best way to diagnose     a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily     available to suspected food allergy sufferers. This study is designed to examine the     effectiveness of an allergy-detecting blood test called ImmunoCAP manufactured by the     company, ThermoFisher.      Soybean is one of the eight allergy-inducing foods that are responsible for 90% of all food     allergies. A part of the study is to allow the study Sponsor to use some of the blood sample     collected from you to test if genetically-changed soy has more or less allergy producing     factors. This is important to the Sponsor to test the safety of their genetically modified     soy.   "
102047|NCT01950546|"     This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the     growth of S. mutans present in dental plaque of children.   "
102049|NCT01950520|"     Background:      - Changes in how a person s body burns energy or calories can affect their weight over time.     The lowest level of energy the body needs to function is called basal metabolic rate. In the     cold, we burn extra energy, even before we start to shiver. This is called non-shivering     thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers     want to learn more about this type of energy burning and how it is regulated. They hope this     will help treat obesity in the future.      Objectives:        -  Sub-study 1: to better understand how non-shivering thermogenesis works.        -  Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate.        -  Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic          receptor agonist, on brown fat activity.      Eligibility:      - Healthy, lean adult males ages 18 to 35.      Design:        -  Participants will be screened with medical history, physical exam, blood test, and EKG.        -  For sub-studies 1 and 2:             -  Participants will receive one X-ray scan.             -  Each day, all participants will:      <TAB>- Have height and weight measured, and have urine collected.        -  Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and          computer. They will wear small non-invasive devices to monitor activity, heart rate,          temperature, and shivering.      <TAB>- Walk for 30 minutes.      -For sub-study 3:        -  Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs        -  Each stay, all participants will:      <TAB>- Have height and weight measured, and have urine collected.        -  Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and          computer. They will wear small non-invasive devices to monitor activity, heart rate,          temperature, and shivering.        -  Participants will be compensated for their time and participation at the end of the          study   "
102050|NCT01950507|"     Background:      The gastrointestinal (GI) tract is commonly affected by acute graft-versus-host disease     (aGVHD) and chronic GVHD (cGVHD) in patients who have undergone blood or marrow stem cell     transplantation (BMT). Initially, patients are treated with systemic corticosteroids, which     produce complete response rates in 35 percent. Although short courses of steroids are     preferred to minimize adverse effects, many patients require systemic treatment chronically     since GI GVHD can negatively impact quality of life and nutrition status. One option to     minimize systemic steroid exposure is by nonabsorbable corticosteroids that act locally on     the GI tract.      Budesonide (Entocort EC, AstraZeneca, Wilmington, DE) is an FDA-approved oral topical     corticosteroid for the treatment of mild to moderate active Crohn s disease involving the     ileum and/or the ascending colon, and for maintenance of clinical remission of mild to     moderate Crohn s disease involving the ileum and/or the ascending colon for up to 3 months.     It has a high ratio of topical-to-systemic activity with minimally active metabolites, and     undergoes extensive first-pass metabolism. Since both intestinal GVHD and Crohn s disease     seem to share a similar pathogenic background, budesonide has been used in the BMT setting     for GI GVHD, usually in combination with systemic corticosteroids (e.g. methylprednisolone)     to improve clinical response and allow for more rapid tapering of systemic corticosteroid     doses.      First-pass metabolism is mediated mostly by the cytochrome P450 (CYP450) enzyme system. The     liver is the major site of CYP450-mediated metabolism but the enterocytes of the intestinal     epithelium are also an important site for drug metabolism. Budesonide undergoes significant     metabolism by CYP enzymes with substantial first-pass metabolism. The potential for greater     systemic availability of orally administered budesonide exists when it is given concurrently     with triazole antifungals, which are commonly prescribed for prophylaxis or treatment of     fungal infections after transplantation. Fluconazole and voriconazole are moderate and strong     inhibitors of CYP3A4, respectively, and budesonide is a CYP3A4 substrate. Inhibition of     CYP3A4 may impair the metabolism of budesonide, resulting in systemic concentrations of     budesonide and subsequently, adverse effects such as hyperglycemia. If the presence of     fluconazole or voriconazole does impair budesonide s metabolism, then dose adjustments to     budesonide may be warranted.      There are no prospective studies evaluating the effects of fluconazole or voriconazole on     budesonide s pharmacokinetics in patients who have undergone BMT.      The primary objective of the proposed study is to determine the effects of fluconazole and     voriconazole on the trough (Cmin) and peak (Cmax) of budesonide in patients who have     undergone BMT and who have GI GVHD.      The primary endpoints are the Cmin and Cmax of budesonide. Secondary endpoints include the     Cmin of voriconazole.      Objectives:      The proposed study seeks to determine the effects of fluconazole and voriconazole on the     Cminand Cmax of budesonide.      Eligibility:      Adult and pediatric subjects (greater than or equal to 13 years of age and greater than or     equal to 49 kg) who are registered to an NCI or NHLBI protocol who have undergone a bone     marrow, cord, haplo-cord or peripheral blood stem cell transplantation who have GI GVHD as     determined by the medical team and who require treatment with budesonide and are candidates     for antifungal therapy are eligible for this study.      Design:      Each subject will serve as his or her own control to minimize the variation in absorption,     distribution, metabolism and elimination of oral budesonide that can occur from subject to     subject, due to genetic, anatomic or other unidentified differences. For example, genetic     polymorphisms of CYP2C19, which is significantly involved in voriconazole s metabolism, could     otherwise affect the results of the study (i.e. CYP2C19 poor metabolizers may experience     higher voriconazole serum concentrations, which could results in greater CYP3A4 inhibition     and higher budesonide exposure). In addition, the longitudinal cohort design of this study     will be able to answer the research questions posed with fewer research subjects. Research     subjects will be accrued into one of three cohorts depending on the antifungal prophylaxis     (or lack thereof) the subject is receiving at study entry and the preference of the medical     team for continued antifungal coverage after the initiation of budesonide and systemic     corticosteroids. Subjects who are not currently receiving antifungal prophylaxis or who are     on fluconazole at baseline are eligible for enrollment in Cohort 1. Subjects in Cohorts 2 and     3 are receiving voriconazole and fluconazole at study entry, respectively. In Cohort 1, if     applicable, subjects will stop fluconazole on day -1...   "
102051|NCT01950494|"     Hand dermatitis, (a rash, or eczema, on the hands) is a common skin condition that affects     approximately 10% of the population. It can be caused by a wide variety of things, such as     allergens or irritants. For some, it can be painful and disfiguring. In moderate to severe     cases, hand dermatitis can interfere greatly in the quality of life of the affected person,     interfering with work and social functions. This can have a negative psychological effect as     well.      FiteBac Skin Care Gel is a new over-the-counter hand sanitizer that has been used for     hospital and dental hand infection control. This product contains a germicide, to prevent     infection. It also contains a silicone polymer. This makes the hand gel more durable, causing     it to remain on the skin longer. Despite this durability, the hand gel still allows the skin     to naturally perspire (sweat).      As people in the health-care industry have used this new product with the goal of reducing     hand infections, it has been noted that FiteBac Skin Care Gel also seems to have reduced hand     dermatitis and improved personal skin condition. The purpose of this study is to     scientifically measure skin improvement in a population of study subjects with hand     dermatitis.   "
102052|NCT01950481|"     Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired     hepatic function and healthy subjects with normal hepatic function.   "
102053|NCT01950468|"     This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the     safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of     parkinsonian syndromes from non-parkinsonian tremor.   "
102054|NCT01950455|"     This is a phase 3, open-label, multiple-center, non-randomized single dose study to assess     the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of     parkinsonian syndromes from non-parkinsonian tremor.   "
102776|NCT01940900|"     The objectives of this study are to evaluate the safety and efficacy of intravitreal     administration of Fovista® administered in combination with Lucentis® compared to Lucentis®     monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related     macular degeneration (AMD).   "
102056|NCT01950429|"     Background:      - Sickle cell disease changes the shape of red cells. This makes them more likely to break     down as they get stuck in small blood vessels. This leads to low red cell count and also     damage to small blood vessels that supply many organs. One of the affected organs is the     liver. Sickle cell disease and its treatment through blood transfusion can lead to     significant liver damage. This disease also can cause the liver to regrow abnormally after     damage. This can cause high blood pressure in the liver. Researchers want to know if curing     sickle cell disease with a stem cell transplant improves liver damage.      Objectives:      - To explore specific factors that improve or worsen sickle cell liver disease after a stem     cell transplant.      Eligibility:      - Adults ages 18 and older with sickle cell liver disease.      Design:        -  Participation will take approximately 7 days over 2 years.        -  Visit 1: participants will be screened with medical history and review of current          treatment regimen.        -  Visit 2: participants will return to the clinic for explanation of the study and          physical exam. They will also have blood and urine tests, and scans of the liver.        -  All participants will have a 2-night stay at the clinic. They will have a liver biopsy          and a test of liver pressure. They will be sedated and a tube will be inserted in a vein          in their neck.        -  Participants who have a stem cell transplant will have a second biopsy about 24 months          later.        -  Over the 2-year study period, participants will have blood drawn 2-4 times and stool          samples collected 2 times.   "
102057|NCT01950416|"     This is a two-center, prospective, randomized, single-blind, investigator initiated,     pharmacodynamic study of parallel design, carried out in 2 PCI-capable cardiology centers     (Patras University Hospital and Konstantopoulio General Hospital of Athens).      Patients with ST elevation myocardial infarction, having undergone fibrinolysis in the     previous 3 to 48 hours, who present high residual PR (defined as PRU ≥208 ) on admission, pre     coronary angiography, will be randomized after written informed consent, in a 1:1 ratio to     either:      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6     hours post LD, until discharge.      Or      Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD)     starting 12±6 hours post LD, until discharge.      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 2, 24 hours     after randomization, as well as pre-discharge, using the VerifyNow assay, in platelet     reactivity units (PRU).      Documentation of major adverse cardiac events (death, myocardial infarction, stroke, ischemia     driven revascularization procedure with PCI or CABG) and bleeding (according to BARC     criteria) will be performed until patient's discharge.   "
102058|NCT01950403|"     This randomized phase I trial studies the side effects and best dose of linaclotide acetate     in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain     drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal     cancer.   "
102098|NCT01949883|"     First in human, open-label, sequential dose escalation and expansion study of CPI-0610 in     patients with progressive lymphoma. CPI-0610 is a small molecule inhibitor of bromodomain and     extra-terminal (BET) proteins.   "
103278|NCT01934257|"     This clinical trial will determine if the formula given to infants experiencing fussiness,     crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve     symptoms.   "
102060|NCT01950377|"     Background:      - Previous research has shown that dopamine, a brain chemical, is involved in decision     making. Different genes influence how much dopamine people have in their brains and how that     affects their behavior. Researchers will study if genes associated with dopamine affect     decision making and impulsiveness. All participants will take tests; some will have brain     images taken. Researchers will study the test responses and images; they will look for how     differences in these genes affect different types of decision making.      Objectives:      - To see if genes involved in a brain chemical, dopamine, are related to impulsiveness on     behavioral tests.      Eligibility:      - Healthy adults ages 18 to 55.      Design:        -  Participants will be screened with a medical history and physical exam.        -  All participants in this study will have at least 1 outpatient visit to the NIH Clinical          Center. Each visit will last 2 4 hours. At the first visit:        -  A blood sample will be taken only from participants that have not been previously          enrolled in 95-M-0150        -  Participants will be given tests of their memory, attention, concentration, and          thinking.        -  Some participants will have a second visit. It will be scheduled as soon as possible          after the first. At the second visit:        -  Participants will have an MRI (magnetic resonance imaging). They will have to lie in a          scanner for up to 2 hours. The MRI uses magnets, radio waves, and computers to produce          detailed pictures of the brain.        -  Participants will repeat the tests from the first visit. Some will be done during the          MRI.   "
102061|NCT01950364|"     This is an open-label trial to estimate the concentrations of brentuximab vedotin in     relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large     cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab     vedotin + rifampicin.   "
102148|NCT01949272|"     Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system     plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and     transpulmonary pressure calculation. Opera study should confirm if a setting approach based     on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious     side-effect.   "
102062|NCT01950351|"     The goal of this clinical research study is to learn if delivering proton therapy in higher     doses per treatment may help control prostate cancer just as well as the standard of care     treatment. The safety of this treatment will also be studied.      Radiation dose is measured in units called Gray (Gy). The standard of care treatment schedule     for proton therapy is 1.8-2 Gy, given 1 time per day, 5 days per week over a period of 8-9     weeks.   "
102063|NCT01950338|"     Stroke is the leading cause of physical disability, particularly due to the presence of     spasticity. Different needling techniques, including the use of Botulinum Toxin A are     proposed for the management of spasticity. The presence of spasticity in the lower extremity     implies several impairments for standing and walking inducing high disability. No study has     investigated the effects of deep dry needling inserted into the targeted spastic musculature     in patients with stroke. The investigators will conduct a randomized controlled trial     investigating the effects of a single session of deep dry needling over the musculature of     the leg on spasticity, widespread pressure pain sensitivity and plantar pressures     (baropodometry) in individuals with chronic stroke. The investigators hypothesize that     patients receiving a single session of dry needling would exhibit a greater reduction in     spasticity and pressure sensitivity than those who will not receive the intervention.   "
102064|NCT01950325|"     This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody.     VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation     study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is     that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV)     and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be     collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and     how long VRC01 can be detected in the blood after it is given.      Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose     escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40     mg/kg. There is 1 group for SC administration at 5 mg/kg. Each group is expected to include     at least 3 participants. Each participant will receive two infusions of VRC01 with about 1     month between doses. Infusions are administered in an inpatient unit and an overnight stay at     the NIH Clinical Center is required. No more than one subject per day per group will receive     a first infusion of the VRC01 product by the IV route and no more than one subject per week     will receive a first infusion of the product by the SC route. Study participation lasts for     24 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored.     Samples will be collected and stored for research purposes.   "
102065|NCT01950312|"     The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy     in patients with steroid resistant Autoimmune Inner Ear Disease.   "
102066|NCT01950299|"     VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra     standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI)     measuring the effects on the acute rise and fall of the plasma C reactive protein levels     during the first 14 days.   "
102067|NCT01950286|"     Hyper-CVAD (a chemotherapy regimen) has shown promising results in adult T-cell Acute     Lymphoblastic Leukemia (T-ALL). Patients with T-ALL diagnosis were reported to the Swedish     Adult Acute Leukemia Registry between October 2002 and September 2006. Hyper-CVAD was     recommended to all patients without severe comorbidity. Allogeneic stem cell transplantation     was recommended for patients with high-risk disease. The aim of this population-based study     was to assess the efficacy of Hyper-CVAD treatment.   "
102068|NCT01950273|"     The primary objective of the study is to assess the pharmacokinetic (PK) similarity of     Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients     with low tumor burden follicular lymphoma (LTBFL).      The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and     anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of     anti-drug antibodies (ADAs).   "
102069|NCT01950260|"     The study will try to answer the question of whether early treatment with levothyroxine at 4     weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low     thyroid hormone levels).   "
117193|NCT01751958|"     Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during     lumbar ESI   "
102079|NCT01950130|"     Due to advances and increased practice of interventional therapy for coronary artery disease,     the rate of high-risk patients with severe coronary disease and reduced left ventricular     function among patients undergoing coronary artery bypass grafting surgery (CABG) is     increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and     operative management for these patients has to be optimized in order to reduce their     perioperative morbidity and mortality. One of the central aspects is perioperative     maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established,     but not sufficiently evidence-based measure to reduce ventricular afterload and improve     coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with     potential complications. The planned trial should give an explicit answer, whether     preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and     long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative     conservative treatment in high-risk patients undergoing CABG.   "
102149|NCT01949259|"     A retrospective, data mining project that re-uses routine patient care data for decision     support systems.   "
102846|NCT01939964|"     To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.   "
102072|NCT01950221|"     This project is designed to study whether pomegranate extract benefits cognitive abilities in     middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of     two treatment groups: either a placebo or the pomegranate extract supplement. Both the     placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain     blindness. Subjects will take one 1000 milligram capsule daily for twelve months.      The investigators expect the people receiving the pomegranate extract supplement to show     better cognitive performance compared with those receiving a placebo after one, six, and     twelve months. The investigators believe cognitive decline and treatment response will vary     according to a genetic risk for Alzheimer's.      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects     will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to     rule out other neurodegenerative disorders linked to memory complaints.      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.     Following the first assessment, subjects will begin taking the supplement (either the     pomegranate extract or the placebo). Subjects will undergo a brief memory test at one-month     mark. At six months, subjects will have a second, full neuropsychological assessment. The     final assessment will take place at the end of the study, the 12-month mark. Additional blood     will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if     outcomes are positive. Subjects will also be asked to come to the University of California,     Los Angeles (UCLA) at 3 and 9 months for supplement refills.      In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13     months.   "
102073|NCT01950208|"     the purpose of this study is to develop and validate a new PRO measurement tool for the knee     joint, the so-called Munich Knee Questionnaire (MKQ), allowing for a qualitative     self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS), the International     Knee Documentation Committee (IKDC), the Lysholm Knee Score, the Western Ontario Meniscal     Evaluation Tool (WOMET) and the Tegner Score.   "
102074|NCT01950195|"     This research is being done to look at the safety of using stereotactic radiosurgery (SRS)     and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both     Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of     care uses both of these treatments but not together. By using them together, we expect better     treatment of melanoma, but there might be an increase in side effects.      Ipilimumab is approved by the Food and Drug Administration (FDA) for the treatment of     melanoma that has spread throughout the body. It works by activating your immune system to     fight off cancer.      Stereotactic radiosurgery (SRS) is approved by the Food and Drug Administration (FDA) for     the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without     needing to cut or use stitches.      The use of combining SRS and Ipilimumab in this research study is investigational. The word     investigational means that this combination is not approved for marketing by the Food and     Drug Administration but is allowed for use in this research study.   "
102075|NCT01950182|"     The primary objective of this study is to compare progression-free survival (PFS) of patients     with metastatic Luminal B2 breast cancer subtype randomised to treatment with Trastuzumab     Combined With Chemotherapy or Endocrine Therapy.   "
102076|NCT01950169|"     The study hypothesis is that nutritional supplementation together with bisphosphonates have a     better preserving effect on bone mineral density (BMD) after hip fracture than     bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months     preserve lean body mass in elderly hip fracture patients.   "
102077|NCT01950156|"     The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,     which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets     for vaccination against lung cancer. In this clinical study, the investigators examine using     a combination of these three peptides the safety, immunogenicity, and antitumor effect of     vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced     non-small cell lung cancer patients whose disease are controlled after any standard     therapies.   "
102093|NCT01949948|"     BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only     approved acute drug treatment <4½ hours of stroke onset. The overall benefit from alteplase     is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening     of the vessel and up to 40% of the patients may remain severely disabled or die, leaving     substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may be     more effective and may have less bleeding complications than alteplase, and may be the drug     of choice also in stroke.      HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a dose     that is associated with improved clinical outcome compared with existing treatment options.      AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given <4½ hours after     symptom onset.      STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months     (effect). Secondary study endpoints are major early clinical improvement (effect) and     bleeding complications (safety).   "
102094|NCT01949935|"     The hypothesis is that application of Mupirocin to the nose before and after coronary artery     bypass grafting surgery will reduce the incidence of surgical site infections.   "
102078|NCT01950143|"     The biology of prostate cancer is associated with changes in genes and metabolites within     prostate tissue. There is robust evidence to suggest that a diet rich in broccoli can prevent     or retard the development of prostate cancer by influencing these changes. This is likely to     be due to a natural chemical that is obtained in these vegetables known as sulforaphane.      In this study, we are seeking to provide further evidence that a diet rich in broccoli may     prevent prostate cancer from developing, and to understand how this may happen. We propose to     undertake a human intervention study to test the hypothesis that a broccoli-rich diet can     alter the metabolism and gene expression within prostate tissue of men under active     surveillance in a manner that would reduce the probability of the emergence and progression     of aggressive cancerous clones. Participants recruited onto this study will be randomly     allocated to one of three dietary groups in which they will be required to consume one     portion per week of a broccoli soup delivering a different concentration of sulforaphane.     This will be part of their normal diet for one year.      Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month     intervention period. Prostate biopsies will be obtained either though transperineal template     biopsies, a technique accepted as best clinical practice because it provides better sampling     of the prostate, or transrectal ultrasound guided biopsy which is currently the standard of     care for obtaining biopsies.      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)     and Prostate Cancer foundation (PCF).   "
102080|NCT01950117|"     Recently, it was reported that the incomplete resection rate of neoplastic large polyps after     conventional polypectomy was markedly high in clinical practice. The incomplete resection     rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.      The aim of this study is to compare the incomplete resection rate of neoplastic large polyps     after EMR or conventional polypectomy. The EMR technique is preferable to conventional     polypectomy for the complete resection of the large polyps (>15 mm in diameter)   "
102150|NCT01949246|"     The prospective study aims:        1. To determine the role and mechanism of biomarkers for prediction of response to CRT        2. To determine the role of biomarkers and their effect on left ventricular remodeling in          patients undergoing CRT.   "
114746|NCT01783899|"     The objective of this study is to assess the effectiveness of Hemospray in achieving initial     hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.   "
102081|NCT01950104|"     Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results     of assisted reproduction techniques through the selection of embryos free of chromosomal     abnormalities.      At present, it has not been proved that the usage of PGS really improves the live birth rate     in IVF cycles. However, it has been stated that the reason of not having better results when     using PGS is that the methodology applied is not adequate.      Several authors propose that the optimal methodology for PGS includes the application of     comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo     biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo     biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage     of blastocyst-stage biopsy instead of day 3 biopsy.      The purpose of this clinical study is analysing the results of the IVF cycles with embryo     biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates     together with embryo quality will be analysed and compared between two groups of patients     undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the     embryo development, while in the other group the embryo biopsy will be fulfilled at the     blastocyst stage.   "
102082|NCT01950091|"     Nonspecific low back pain (NLBP) is the diagnosis for 85% of low back pain sufferers with no     underlying medical cause (e.g., herniated disc, spinal stenosis) that requires physician     care. Treatment, however, is impractical for many physicians to implement during office     visits, and there are relatively few providers for NLBP treatment that follow national pain     control guidelines. This study evaluated the efficacy of an on-line intervention using     desktop computers or mobile technology to help users self treat NLBP occurrences and to     engage in activities to decrease future occurences.   "
102083|NCT01950078|"     Objective: This study was conducted to explore the possible correlation between some gene     related to pain sensation and individual basal pain perception and postoperative pain     intensity in the general population. Methods: Patients receiving elective surgery under     general anesthesia were recruited into this study. The investigators measured their     preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). Pain intensity     at rest and movement after the operation was evaluated . And the PCA drug consumption were     recorded. Also there were healthy college students volunteer be recruited into this study.     The investigators measured their experimental pain sensitivity including pressure pain     threshold (PPT) and pressure pain tolerance (PTO), etc. Then genotyping was carried out.   "
102084|NCT01950065|"     Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the     appearance of forehead wrinkles.   "
102095|NCT01949922|"     Aim:      To investigate efficacy and safety in a new treatment with injection of autologous muscle     fibers into the anal sphincter in patients with fecal incontinence.      Method:      Patients with fecal incontinence after obstetric anal sphincter rupture will be included.     After inclusion, they will be offered 3 months of pelvic floor muscle training. If the     patients after completion of pelvic floor muscle training still suffer from fecal     incontinence, the patients will be offered treatment with autologous muscle fiber injection     into the anal sphincter. The patients will be followed one year after the injection. The     autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and     injected into the anal sphincter. A small part of the fibers are used for analysing number of     muscle stem cells and thereby the regenerative potential of the sample.      The study is a pilot study.   "
102096|NCT01949909|"     P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and     immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen     and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European     volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase     Ib).   "
103279|NCT01934244|"     This post approval, observational study is being conducted to further evaluate the safety of     the NovaSure Endometrial Ablation System when it is performed in the presence of Essure     micro-inserts.   "
102085|NCT01950052|"     This study is a randomised control trial comparing the effects of a pre-operative very low     calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric     surgery.      The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Some     centres ask their patients to take a VLCD 2-6 weeks before bariatric surgery with the aim of     shrinking the liver to make surgery easier. Studies have shown that after this diet the liver     does shrink and therefore operating may be easier but this did not necessary translate into     significant lesser operative times. The effects of operating during a catabolic phase have     not been evaluated. Theoretically a low calorie diet before surgery is similar to starving a     patient and can potentially create a state of malnutrition. This is rarely advisable before     surgery and can lead to poor wound healing and poor healing of bowel anastomosis.      This study will ascertain if there is any difference in wound healing rates in these morbidly     obese patients (BMI>40kg/m2)undergoing a Laparoscopic Roux en Y gastric by pass in groups who     have taken the preoperative diet compared to those who were not on a special diet. Skin     wounds will be evaluated. This will potentially reflect the general state of healing of the     patient which includes the healing of bowel anastomosis. Surrogate markers will be employed     to evaluate the pre-morbid nutritional state, effectiveness of dieting, subsequent wound     healing (collagen production, markers for the different aspects of wound healing) and impact     on liver cell death .This study will be able to tell us how safe this calorie deficient diet     is in these morbidly obese patients before surgery.   "
102086|NCT01950039|"     Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine     levels to diabetes and cardiovascular disease. Small human studies suggest benefit for     non-alcoholic liver disease. In this study we will determine if administration of betaine     improves metabolic measures, liver fat and/or endothelial function in humans with glucose     intolerance who are overweight.   "
102087|NCT01950026|"     The aim of this study was to reheat the skin in different ethnic groups after application of     cryotherapy.   "
102088|NCT01950013|"     The purpose of this study is to investigate the effectiveness of an auditory training program     used at home with the subject's own hearing aids.   "
102089|NCT01950000|"     Background: Few studies have addressed the situation of procedural pain and the use of     preemptive analgesia for turning in patients under mechanical ventilation.      Aim: Evaluation effect of preemptive fentanyl on the incidence of pain during turning     maneuvers in critically ill patients under mechanical ventilation.      Design: Single-center clinical trial, national, randomized, double-blind, with a parallel     group, and two arms of treatment: saline placebo and fentanyl.      Primary Endpoint: Incidence of pain during the turning procedures that are carried out by     nurses measured by means of the Behavioral Pain Scale (BPS).      Study Population: Critically ill patients, age > 18 years, admitted to ICU and expected to     require mechanical ventilation for at least 24 h.      Sample Size: 80 patients divided into the two groups (40 patients each). Statistical     Analysis: A preliminary descriptive analysis will be carried. Later, results of primary end     point will be comparing after the eventual corrections of corresponding variables using a     multivariable approach. The AUC variable will be analyzed by a t-test for unpaired data. A     second analysis using a multivariate approach will be carried out for those factors     considered as clinically relevant in relation to pain and therefore a logistic regression     will be used.      Ethical Considerations: The study will be strictly conducted following the Declaration of     Helsinki and the protocol and Standard Operating Procedures (SOPs) to ensure compliance with     the Good Clinical Practice (GCP) standards. It is the responsibility of the researcher to     obtain the valid informed consent from the guardian / legal representative, as the patient's     condition will not allow to consent. Before obtaining the consent the investigator will     explain to each guardian / legal representative the nature of the study, its purpose, the     procedures, the estimated duration, the potential risks and benefits associated with the     participation, as well as any inconvenience that this may involve.      Duration of Treatment: The treatment has a maximum duration of 60 min for each patient. The     follow-up includes visits and has duration of 6 consecutive days.      Safety Assessment: Potential side effects of treatments will be recorded. Frequent adverse     effects of fentanyl administration include respiratory depression, apnea, muscle rigidity,     bradycardia and transient hypotension.   "
102151|NCT01949233|"     The primary objective of the trial is to estimate the effects of allocation to irbesartan, or     doxycycline, or a combination of both irbesartan and doxycycline, compared with placebo, on     measures of elastic function of the aorta in people with the Marfan syndrome and enlargement     of the aorta.   "
102090|NCT01949987|"     Pain score after inguinal hernia repair surgery in children decreased as time passed in     previous studies. Postoperative oral intake is usually resumed two hours after minor surgery     in most of institutions, that may influence children's behavior and pain score.      A recent study suggest that oral intake one hour after minor surgery does not increase the     incidence of postoperative nausea and vomiting.      The investigators primary endpoint is to clarify whether postoperative oral intake influences     postoperative pain score in children.   "
102091|NCT01949974|"     The purpose of this clinical trial is to compare a non-pharmaceutical intervention (Integral     Attention Program or PAI) versus standard palliative chemotherapy treatment plus PAI in     patients with advanced cancer who have already received at least a first course of     chemotherapy but had proven therapeutic failure.      The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to     quality-of-life-adjusted survival compared to a comprehensive care program.   "
102092|NCT01949961|"     BACKGROUND: Thrombolytic drugs may dissolve blood vessel clots in acute ischemic stroke. The     overall benefit of intravenous thrombolysis is substantial, but up to 2/3 of patients with     large clots may not achieve re-opening of the vessel and up to 40% of the patients may remain     severely disabled or die. Ultrasound accelerates clot break-up (lysis) when combined with     thrombolysis (sonothrombolysis) and increases the likelihood of functional independence at 3     months. Adding intravenous ultrasound contrast (gaseous microspheres) further enhances the     thrombolytic effect (contrast enhanced sonothrombolysis = CEST). Contrast enhanced ultrasound     may also accelerate clot break-up in the absence of thrombolytic drugs (contrast enhanced     sonolysis = CES).      HYPOTHESIS: Contrast enhanced ultrasound treatment administered within 4 1/2 hours after     symptom onset may be given safely to patients with acute ischemic stroke, both to those     receiving intravenous thrombolysis and those not receiving intravenous thrombolysis, and will     improve clinical outcome.      AIMS: To compare efficacy and safety of contrast enhanced ultrasound treatment vs. no     ultrasound treatment in patients with acute ischemic stroke receiving or not receiving     intravenous thrombolysis.      STUDY ENDPOINTS: The primary endpoints are 1) neurological improvement at 24 hours (proof of     concept) and 2) excellent clinical outcome at 3 months (effect). Secondary endpoints are     bleeding complications (safety), brain damage (infarct size/location) and early clinical     improvement (effect).   "
103424|NCT01932359|"     This study aims to compare scar outcomes between rapidly absorbable and non-absorbable     sutures (stitches) for the closure of wounds after skin cancer removal on the face.   "
102099|NCT01949870|"     The objective of this study is to investigate the safety and tolerability of oral dose of     selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese     patients with advanced biliary tract cancer (BTC). In addition, the pharmacokinetic (PK)     profile of selumetinib and chemotherapies will be investigated. Also, the Maximum tolerated     dose (MTD) of selumetinib in combination with chemotherapies for Japanese BTC patients will     be identified, if possible.   "
102100|NCT01949857|"     The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune     persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.   "
102152|NCT01949220|"     Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify     the therapeutic practices in an international environment.   "
118070|NCT01740505|"     This study will compare three different exercise programs in older adults who report     difficulty walking and will determine if the programs improve walking.   "
102101|NCT01949844|"     This is a pilot study in a patient population with suspected Coronary Artery Disease CAD) as     defined by the presence of an abnormal nuclear (PET/SPECT) perfusion scan. In this study     design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia.     We intend to determine the accuracy of a novel MR technique for localization of perfusion     deficits in comparison to PET/SPECT.      This is not a study to specifically evaluate the efficacy or safety of the drugs but rather     the diagnostic accuracy of the cardiac MRI procedure as a whole   "
102102|NCT01949831|"     The aim of this study is to examine the effect of systematic assessment of functional     ability, development of rehabilitation plan and follow-up at home for elderly medical     patient's risk of readmission. The effect of the intervention is examined in a randomized     controlled trial.   "
102103|NCT01949818|"     The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule     Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.   "
102104|NCT01949805|"     Phase III study to compare the efficacy and safety of the novel monopegylated interferon     alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year     treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of     AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated     patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab     parameters as well as normalized spleen size.   "
102105|NCT01949792|"     This trial is conducted in Europe. The aim of the trial is to investigate the     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the     effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII)     following one single injection of 270 microg/kg compared to three injections of 90 microg/kg     rFVIIa in patients with haemophilia.   "
102106|NCT01949779|"     The primary objective of this registry is to collect real world data on the safety and     performance of the TransForm™ Occlusion Balloon Catheter when used in current     neurointerventional procedures   "
102108|NCT01948557|"     Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of     HIV infection being passed to her child either during pregnancy or during the labour process.     However, children can also become infected by drinking the mother's breastmilk which contains     the HIV virus. In many poor, developing countries in Africa, breastfeeding is the normal way     of infant feeding and is vitally important because of the protection it gives to children     from other diseases such as diarrhoea and malnutrition. Ideally there would be a way to make     breastfeeding safer from HIV transmission without losing its other advantages.      A medical study recently suggested that HIV-infected women who exclusively breastfed their     children i.e. gave breastmilk but without any water, tea, formula milk or any solid foods did     not pass on the virus to their children to the same degree as women who MBF with these other     fluids and foods. It is important to confirm whether this observation is in fact true or not.     We hypothesize that exclusive breastfeeding by HIV-infected mothers carries a lower risk of     HIV transmission than mixed breastfeeding.      We propose to follow 2,100 HIV-infected pregnant women and also some HIV-uninfected women     from the time that they book at the clinic until 24 months of age. HIV-infected women who say     they intend to breastfeed and all the HIV-uninfected women will be visited at their homes by     breastfeeding counsellors both before and after delivery to support exclusive breastfeeding.     HIV-infected women who choose not to breastfeed will be helped by clinic staff to safely     replace all breastmilk with some other milk. An independent team will visit all mothers at     their homes and collect information about the way they feed their children. Blood samples     will be collected from the children at different times by a simple heel prick and the blood     stored on a piece of filter paper. By testing these samples and comparing with the type of     feeding at that time, we will be able to see when a child becomes infected and whether     exclusive breastfeeding gives any protection.   "
102109|NCT01948544|"     -  Evaluate subjects in an prospective observational study        -  Subjects will be administered scientifically validated questionnaires        -  Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in:             1. Exercise capability, dyspnea and quality of life as primary endpoints             2. Utilize:                  1. Baseline Dyspnea Index (BDI)                  2. Transitional Dyspnea Index (TDI)                  3. Chronic Respiratory Disease Questionnaire (CRQ)                  4. Six minute walk test (6MWT)                  5. Epworth Sleepiness Scale (ESS)        -  The secondary endpoints will be:             1. Rate of exacerbations, sleep quality             2. Health care utilization (emergency room encounters, hospital admissions)   "
102110|NCT01949766|"     This is a single patient compassionate use protocol to determine whether RAVICTI will improve     bile flow in a subject who previously tolerated therapy with Buphenyl.   "
102111|NCT01949753|"     Characterization of the influence of pregnenolone vs. placebo on subjective distress and     autonomic functioning during cognitive-behavioral exposure therapy in patients with     obsessive-compulsive disorder.   "
102112|NCT01949740|"     This pilot research trial studies patient preferences in making treatment decisions in     patients with stage I-IVA oropharyngeal cancer. Questionnaires that measure patient     priorities before and after treatment may improve the ability to plan for better quality of     life in patients with oropharyngeal cancer.   "
102123|NCT01949597|"     The recurrence of endometriosis after surgery a formidable challenge for the gynecologist.     Recurrence rates reported in the literature are very high, being 21.5% at 2 years and 40-50%     at 5 years. Several theories attempt to explain these high figures. The three most widely     accepted are:        -  The presence of residual endometriotic tissue or residual endometriotic cells not          completely eradicated during surgery        -  The growth of undetected microscopic endometriosis during surgery        -  The development of endometriotic lesions de novo Patients with symptomatic endometriosis          diagnosed by ultrasound or MRI and suitable for surgery will participate in the study.          The surgical specimens sent for pathology from bladder, vagina, uterosacral, sigma or          rectum will be properly marked for studying the presence of endometriosis.   "
102125|NCT01949571|"     INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the     high rate of relapses occurs within the first months after detoxification. In the early     withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as     crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects of     the substance, known as craving. Most of the times, these clinical symptoms act as negative     reinforcement, which can be severe enough to induce a drug-relapse that greatly hampers the     treatment.      TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine     the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1)     To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence     disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy of     reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in     subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the     maintenance of abstinence in patients with cocaine dependence disorder treated with     mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent     on cocaine comorbid with major depressive disorder.      HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction     in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the     neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect     anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of the     National Institute of Psychiatry who meet the inclusion criteria and invite them to     participate voluntarily. If patients accept, send them to the principal investigator for the     start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and     Depression Scale Beck Scale.   "
102847|NCT01939951|"     This study aims to find out if AES ( Activation Energy Serum) , a blend of natural minerals ,     is effective and safe for the treatment of asthma if taken for 4 weeks . The efficacy will be     scientifically tested by symptoms scores, questionnaires, breathing and blood tests.   "
102113|NCT01949727|"     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations     result in frequent, prolonged hospitalizations. While originally considered a disease     specific to the lung, data have shown that COPD is associated with substantial cardiovascular     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with     stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown;     however, it may be due to chronic inflammation which is exacerbated with a flare-up of the     disease, and/or chronic inactivity which is similarly worsened with bed-rest during a     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.     Disease management programs, such as pulmonary rehabilitation and patient self-management     education, are part of guideline therapy for COPD; however, these are not regularly     implemented following a hospitalization, and how these interventions affect patient outcomes,     behavior, physical activity, inflammation and CV risk have not been well studied. The     proposed long-term project will examine how typical inpatient COPD care, and how early     referral to chronic disease management programs after hospital discharge, affect patient     outcomes. This grant brings together an outstanding group of researchers who have the     necessary clinical, content and methodological expertise to successfully complete this work.     These studies will provide invaluable information about inpatient and outpatient management     for a disease which has a tremendous impact on healthcare.   "
102114|NCT01949714|"     -  To investigate the effect of catecholamine excess on brown fat.        -  To evaluate the effect of brown fat on energy expenditure and lipid and glucose          metabolism   "
102115|NCT01949701|"     The investigators previously identified a novel HLA-A*0201-restricted epitope peptide, which     was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung     cancer. In this clinical study, the investigators examine using the peptides the safety,     immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease     for HLA-A*0201-positive advanced non-small cell lung cancer patients whose disease are     controlled after any standard therapies.   "
102116|NCT01949688|"     In this study, the investigators examine using a combination of two types of HLA-A*2402 (or     HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the     safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor     patients who are refractory to standard therapy.   "
102117|NCT01949675|"     The aim of the study is to generate safety and immunogenicity data with Oral Cholera Vaccine     (Shanchol™) in The Philippines      Objectives:        -  To describe the safety after each dose of Shanchol vaccine.        -  To describe the immunogenicity after each dose of Shanchol vaccine.   "
102118|NCT01949662|"     The goal of this clinical research study is to learn if giving lorazepam in combination with     haloperidol can help to control the symptoms of delirium in patients with advanced cancer.     The safety of this drug combination will also be studied.      In this study, lorazepam is being compared to a placebo. A placebo is not a drug. It looks     like the study drug but is not designed to treat any disease or illness. It is designed to be     compared with a study drug to learn if the study drug has any real effect.   "
102119|NCT01949649|"     Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge     eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise Specified     (ED-NOS), which includes subthreshold variants of these disorders. Over half of those     presenting for eating disorder treatment meet criteria for ED-NOS and both threshold cases     and ED-NOS are marked by chronicity, relapse, distress, functional impairment, and increased     risk for future obesity, depression, suicide attempts, anxiety disorders, substance abuse,     morbidity, and mortality. Anorexia and bulimia nervosa show stronger relations to suicide     attempts, outpatient/inpatient treatment, and functional impairment than most other     psychiatric disorders. Treatment of eating disorders is very expensive, similar to the cost     for schizophrenia treatment, and is effective for only 40-60% of patients. Thus, a public     health priority is to develop and disseminate effective eating disorder prevention programs.   "
102120|NCT01949636|"     The purpose of this study is to test the dynamic vulnerability model of obesity using brain     imaging.   "
102121|NCT01949623|"     In this study, markers of oxidative stress will be measured in the aqueous humour and plasma     of RP patients compared to controls.   "
102122|NCT01949610|"     The purpose of this study is to evaluate the absorption, the metabolic pathways (a series of     metabolic reactions) and the excretion of JNJ26489112 in healthy male adult participants     after administration of a single oral dose of 1000 mg of 14C-JNJ26489112.   "
103933|NCT01925716|"     The objectives of this clinical trial are to assess the effects of dietary oils on blood     lipids and other aspects of the fasting lipoprotein profile in healthy men and women with     elevated cholesterol   "
102124|NCT01949584|"     This is a prospective, interventional, study in which patients with a history of habitual     snoring to determine whether low pressure nasal continuous airway pressure can reduce the     frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do     not have Obstructive Sleep Apnea (OSA).   "
102146|NCT01949298|"     Edentulous patients have to wait after extractions and again after surgical implant placement     for healing to occur before the implants can be restored and patients can go back to normal     function. This delay in loading of implants can be handicapping for the patient, esthetically     and functionally. Hence this project was undertaken with the purpose of reducing this wait     period and achieving early rehabilitation in these patients. The aim of the project is to     compare immediate loading versus delayed loading of implant supported mandibular dentures.   "
102126|NCT01949558|"     Chronic diseases such as overweight and cardiovascular diseases represent important threats     to women's health. Pregnancy and lactation are associated with changes in weight, body     composition and lipid metabolism and affect the risk of developing these chronic illnesses.     Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese     women's ability to make longterm lifestyle changes during the postpartum (pp) period, under     ideal study conditions. Physiological mechanisms for weight reduction were investigated with     precise methodology. However, effectiveness studies under different conditions are crucial     for the development of effective programs for the Primary Health Care sector. Hence, the     interest for translational research that brings results from clinical trials to the Primary     Health Care sector has increased. The aim of this effectiveness-study is to investigate if     dietary restrictions pp lead to significantly greater weight reduction among overweight/obese     women, compared to no intervention, in a longterm perspective. In total 106 women will be     recruited 10 wk pp and randomized into 1) control group; 2) dietary restrictions in     individualized intervention during 12 wks. One and two years pp long term effects are     evaluated. Positive results may be integrated into usual practice after the study ends.   "
102127|NCT01949545|"     The purpose of this study is to compare the safety and efficacy of carfilzomib, including     measuring the amount of the study drug in the blood at certain times following dosing. This     study is being done in people with varying degrees of liver function to see if they respond     differently to the study drug.   "
102128|NCT01949532|"     The purpose of this study is to see how the body and the cancer react to carfilzomib,     including measuring the amount of the study drug in the blood at certain times following     dosing. This study is being done in people with normal kidney function and those with     end-stage renal disease to see if they respond differently to the study drug.   "
102129|NCT01949519|"     Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate     cancer. While it has clinically useful activity, there is a strong need for substantial     improvement in its efficacy. Possible ways for improving docetaxel monotherapy would be to     combine it with an agent that either minimized toxicity (thus allowing higher doses) or     improves efficacy (by targeting synergistic pathways). Lycopene is an attractive agent for     combination with docetaxel because of its known accumulation in prostate tissue, its low     toxicity, and its ability to inhibit signaling through the IGF-1 axis, and to reduce IL6     levels. Lycopene is highly synergistic with docetaxel at inhibiting the growth of prostate     cancer in mice. The purpose of this study is to determine the maximum tolerated dose (MTD) of     lycopene given in combination with docetaxel. This dose can then be used for subsequent phase     II or phase III studies.      New findings from the ECOG E3805 study presented at ASCO 2014, showed that concurrent     chemotherapy with first-line ADT for newly diagnosed metastatic prostate cancer markedly     improved overall survival compared with delayed or no chemotherapy. These subjects could also     benefit from intervention to increase docetaxel effectiveness.   "
102130|NCT01949506|"     This is a prospective study to document the local control rates with SBRT specifically for     pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute     and late toxicity, quality of life (QoL), tumor control, and survival.   "
102131|NCT01949493|"     The objective of this study is to evaluate the effectiveness of mechanical traction in     patients with Carpal Tunnel Syndrome compared to care as usual.   "
102132|NCT01949480|"     The overall purpose of this research study is to compare the effectiveness of ultrasound     assisted paravertebral block placement versus traditional blind technique for postoperative     analgesia following thoracotomy or visually assisted thoracoscopic surgery.   "
102133|NCT01949467|"     The diagnosis of iron overload is a common problem. It is important to optimize the diagnosis     to ensure support for patients and their relatives especially regarding genetic disease.      Iron overload revealed by a high level of serum ferritin and confirmed by the presence of an     excessive amount of iron in the liver is a frequent situation. In a lot of case there is no     increase in serum iron and transferrin saturation. This situation may arise in particular in     patients with:        -  a genetic iron overload related to mutation in the ferroportine gene, leading to a          ferroportin disease. The diagnosis is based on the sequencing of the gene,        -  a dysmetabolic hepatosiderosis, the most frequent situation , where iron overload is          associated with abnormalities in the metabolism of carbohydrates and fats, whereas no          genetic cause is identified.      However, patients often have similar biological signs and despite the implementation of     strict algorithm regarding the diagnostic procedure, it appears that a large number of     patients are tested for the mutation in the ferroportin gene, and that mutation is not found     in most cases. It is therefore essential to optimize the diagnosis process by introducing     additional criteria.      The investigators' hypothesis, based on the known elements, is that the response to a single     dose of iron will modulate differently the iron parameters measured in serum, including     hepcidin level which controls iron metabolism and metals associated with iron. This could be     helpful for diagnosis procedure in patients with ferroportin disease or dysmetabolic     hepatosiderosis.   "
102194|NCT01948466|"     The overall goal of this project is to learn how positive advertising messages impact school     food choices. More specifically, this study will determine if positive video messages about     fruits and vegetables delivered during the elementary school morning news program can     influence children to select more fruits and vegetables in a school lunch setting.     Additionally, it will determine if assessing food selection is representative of food     consumption by children in a school lunch room setting.   "
102142|NCT01949350|"     Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, measurement     of a patient's preoperative cardiorespiratory reserve, performed non-invasively by     cardiopulmonary exercise testing, has been shown to be predictive of outcome following     non-cardiac surgery. All patients prior to major surgery are starved for a minimum of 6 hours     and often longer prior to major elective surgery. It has been shown that elite athletes who     are hypohydrated have reduced exercise capacity and lower cardiorespiratory function. These     results are further exaggerated in non-trained individuals. Therefore, the starvation     policy prior to surgery may have a deleterious effect on outcome after surgery.      4.2 AIMS This is a pilot study of health volunteers to assess the role of carbohydrate (CHO)     (preload) and carbohydrate-protein (CHO-P) (Highfive energy source 1 in 4) in improving     aerobic capacity after a period of fasting mimicking the current starvation policy prior to     surgery. Both of these have similar calorific value and only differ in the amount of     carbohydrate and protein supplementation.   "
102143|NCT01949337|"     This randomized phase III trial studies enzalutamide to see how well it works compared to     enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant     metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs,     such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens     made by the body.   "
102134|NCT01949454|"     The investigators aim to evaluate a new potentially cost-effective approach to improving     trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The     investigators hypothesize that adjunctive topical fluorometholone therapy following     trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this     hypothesis is that interruption of inflammation postoperatively would reduce postoperative     scarring, leading to better outcomes. As an initial step toward evaluating this modality, the     investigators believe it to be necessary to evaluate topical corticosteroid therapy in a     safety-oriented study, for which the investigators also hypothesize that fluorometholone will     have a perioperative safety profile acceptable for large-scale programmatic use. Topical     corticosteroid therapy is associated with potential risks of cataract induction and     intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower     intraocular penetration than alternative corticosteroids, with correspondingly less     IOP-raising effect while still having favorable effects on conjunctival inflammation, and is     a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an     advantage in this setting, as the major side effects of therapy are the result of intraocular     effects, and therapy only is needed to the conjunctiva. However, prior to use in a     large-scale trial it is sensible to make sure adverse outcomes are not observed in a     substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial     are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal     dosing schedule and to identify any preliminary signals of potential efficacy.   "
102135|NCT01949441|"     House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and     fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with     poorer lung function, greater medication requirements and more asthma symptoms as well as     chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA     leads to the development of asthma, in addition to exacerbating pre-existing asthma in     HDM-sensitised patients.      ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide     Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.      This study to assess the tolerability of ToleroMune House Dust Mite in subjects with     controlled asthma and house dust mite-induced rhinoconjunctivitis.   "
102136|NCT01949428|"     A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a     History of House Dust Mite-Induced Rhinoconjunctivitis   "
102137|NCT01949415|"     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and     fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with     poorer lung function, greater medication requirements and more asthma symptoms as well as     chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA     leads to the development of asthma, in addition to exacerbating pre-existing asthma in     HDM-sensitised patients.      ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.      Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will     identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002     study participants   "
102138|NCT01949402|"     There is increasing interest in how thoracic (chest) ultrasound might enhance the management     of patients with respiratory failure and breathlessness, particularly in the emergency     admissions or intensive care setting. Thoracic ultrasound is already used in a number of     clinical settings. It is recognised that a number of lung abnormalities can be identified     using thoracic ultrasound, such as consolidation (in pneumonia) or peripheral soft tissue     lesions (in lung cancer). Furthermore, thoracic ultrasound offers clinicians a non-invasive     diagnostic tool that provides immediate feedback and results.      Patients with breathlessness and respiratory failure represent a significant proportion of     emergency admissions to hospital and commonly require urgent treatment with limited     information available to guide the clinician. The range of diseases that present with     breathing difficulties is broad (e.g. pneumonia, heart failure, pulmonary embolus) and     difficult to differentiate in patients who often have multiple medical problems. This leads     to non-specific treatment in the face of diagnostic uncertainty with the associated risks of     treatment complications, increased morbidity and mortality, and distress for patients and     relatives. It is in the assessment of these patients with acute respiratory failure where     thoracic ultrasound might be of greatest benefit and which this research is designed to     address.      This is a single centre study (Churchill Hospital, Oxford) recruiting 125 participants over     an eight month period. The study will test the reliability of a thoracic ultrasound protocol     at identifying lung abnormalities in a stable outpatient population with respiratory disease     (chronic obstructive pulmonary disease; interstitial lung disease; patients on haemodialysis     to replicate acute pulmonary oedema / heart failure). It is hoped the results of this study     will inform further research in acutely unwell patients with respiratory failure and     breathlessness to see whether thoracic ultrasound can improve diagnostic and therapeutic     decisions.   "
102139|NCT01949389|"     The purposes of this study is to examine the feasibility of implementing an internet-based     treatment for insomnia among veterans with substance use disorders, some with co-morbid     serious mental illness, and to develop potential methods to support and encourage veterans     while they self-administer this treatment. Our hypotheses are that the implementation of an     internet-based therapy will be feasible and that a method of support can be devised, and     tested in the future.   "
102140|NCT01949376|"     The purpose of this study is to improve our understanding of potential changes in size, shape     and activity in some brain areas that can occur in women receiving different types of Breast     Cancer therapy, and how these changes are related to the development of mild cognitive     impairment as the result of these treatments.   "
102141|NCT01949363|"     This study is a Phase I, open label, non-randomized, dose-frequency escalation     pharmacokinetics study among 24 healthy male and female subjects, aged 18 to 45 years to     determine the pharmacokinetics and safety of high-, multi-dose cefixime for the treatment of     reduced susceptibility gonorrhea. Stage 1(Cohorts A and B) will examine the pharmacokinetics     of single 400mg and 800mg dose of cefixime. Stage 2(Cohorts C and D) subjects will take 800mg     of cefixime every 12 hours for 2 doses. If that dosing regimen is well tolerated, the     dose-frequency will escalate to 800mg every 8 hours for 3 doses, and serum levels of cefixime     will be measured. Study duration is approximately 47 weeks.   "
102144|NCT01949324|"     This study is a phase 2, randomized, multi-center, single-masked study to evaluate the     efficacy and safety of the NT-501 implants in participants with Mactel.   "
102145|NCT01949311|"     This is an open label extension study for patients who participated in placebo-controlled     dupilumab atopic dermatitis (AD) trials. The study primarily evaluates long term safety     (adverse events) and immunogenicity. Efficacy parameters are based on Investigator Global     Assessment (IGA), Eczema Area and Severity Index (EASI) and the Pruritus Numerical Rating     Scale (NRS).   "
118700|NCT01732458|"     The purpose of this study is to determine the appropriate dosing regimen of aprepitant for     the prevention of post-operative nausea and vomiting in pediatric participants birth to 17     years.   "
102154|NCT01949194|"     In recent years, anti-angiogenic agents have been incorporated into clinical practice for the     treatment of metastatic CRC, leading to improvements in progression-free survival and overall     survival. Regorafenib is an oral multi-kinase inhibitor that targets angiogenic and oncogenic     kinases. Although structurally similar to another multi-kinase inhibitor, sorafenib, it     appears to be pharmacologically more potent and possesses broader antiangiogenic properties.      Both sorafenib and regorafenib target BRAF wild-type and BRAF V600E mutant but the inhibition     of p38 MAP kinase is a peculiar characteristic of regorafenib. A Phase I study of regorafenib     as a single agent in patients with heavily pretreated CRC showed promising clinical activity     with a disease control rate (PR + SD) of 59% in evaluable patients. In the Phase III trial     (CORRECT), which was a randomized double-blind, placebo-controlled study comparing either     regorafenib plus best supportive care (BSC) or placebo plus BSC, it was shown that     regorafenib significantly increased overall survival (OS), progression-free survival (PFS)     and disease control rate (DCR), independently of KRAS status. A major interest, given the     data presented in the CORRECT trial, is to determine predictive biomarkers to indicate     patients likely to benefit, or to be resistant to this anti-angiogenic compound.      This study aims to determine the efficacy of regorafenib as single-agent treatment for the     treatment of second-line metastatic colorectal cancer and to identify predictive biomarkers     in the actual metastatic tumors to be treated. In the case of metastatic CRC patients, liver     lesions are frequently the most common site of metastatic deposit and these lesions can be     biopsied to assess putative biomarkers. Patients will be asked to undergo a biopsy of a     metastatic lesion prior to treatment, and an optional liver biopsy at the time of relapse.     Using several high-throughput discovery platforms, biomarkers will be identified in the     metastatic tumor specimens and in blood samples collected throughout the treatment. This will     allow us to evaluate putative biomarkers and monitor tumor biomarker dynamics using serial     blood collection.      The objectives of this trial are to help identify the patient subgroup most likely to be     responsive or resistant to regorafenib, so that future treatment with regorafenib can be     directed to the more responsive but as yet identified patient population.   "
102155|NCT01949181|"     Prospective research to study the relationship between concentrations of metals/metalloids in     blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive     pulmonary disease.   "
102156|NCT01949168|"     The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy     for the treatment of genotype 6 chronic hepatitis C infection.      Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C     infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic     hepatitis C infection.      The investigators therefore hypothesise that:      i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo.      ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will     cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C     infection.   "
102157|NCT01949155|"     The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201     in the treatment of pediatric subjects with bilateral middle ear effusion who require     tympanostomy tube placement.   "
102158|NCT01949142|"     The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201     in the treatment of pediatric subjects with bilateral middle ear effusion who require     tympanostomy tube placement.   "
102159|NCT01949129|"     The ALL SCTped 2012 FORUM is a multinational, multi-centre, randomized, controlled,     prospective seamless phase II/III study for the therapy and therapy optimisation for children     and adolescents with ALL in CR, who have an indication for HSCT (hematopoetic stem cell     transplantation) with a myeloablative conditioning regimen.      The stratification and randomisation of patients in first and following remission according     to the individual transplantation modalities rests upon an indication for allogeneic HSCT AND     on the availability of a suitable donor within the individual transplantation groups.      Main objectives - Objective 1: Randomisation of TBI vs non-TBI conditioning regimen for     patients with a HLA matched-sibling donor or unrelated HLA matched donor.      We aim at showing that a non-total body irradiation (TBI) containing conditioning     (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to     conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human     leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD).      - Objective 2: Stratification of patients with a HLA mismatched donor according to stem cell     source.      We aim at exploring event free survival (EFS) after HSCT from HLA mismatched donors using     mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family     members with non TBI-conditioning regimen.   "
102160|NCT01949116|"     People with HIV infection who are taking antiretroviral therapy (ART) may be at risk for     cardiovascular disease (CVD), which can be caused by inflammation. Methotrexate (MTX) is a     medication used to treat inflammation in people with rheumatoid arthritis. This study will     evaluate the safety and effectiveness of low-dose methotrexate (LDMTX) at reducing     inflammation in HIV-infected adults.   "
102161|NCT01949103|"     TD-1607, administered intravenously as multiple ascending doses, will be investigated in     healthy subjects to assess its tolerability, safety, and pharmacokinetics.   "
102162|NCT01949090|"     The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of     different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age     and older. The study will evaluate safety related events and antibody immune responses to     different formulations of study vaccine.   "
102163|NCT01949077|"     The purpose of the study is to determine differences in levels of serum chemokines from     patients undergoing treatment with Boceprevir. The aim is to determine if non-responders have     significantly different levels of chemokines than responders.   "
102164|NCT01949064|"     The treatment of craniomandibular disorders is a challenging task. Many different treatments     are yet available with occlusal splints being one of the most commonly used. A relative new     diagnostic and treatment alternative is the Grindcare device. This enables the     electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent     electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a     certain limit. This stimulation results to a sudden break of the muscle activity.      Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain     reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our     null-hypothesis was that there is no difference between the device and the splint in the     reduction of pain intensity.   "
102165|NCT01949051|"     This study will be a randomized, double blind, placebo controlled, 3-way cross over design in     allergic rhinitis subjects. Subjects will receive repeat doses of intra-nasal levocabastine     for 7 days in each period and the duration of the study will be about 13 weeks. An     Environmental Exposure Chamber (EEC) will be used in this study. The primary objective of the     study is to investigate the non-inferiority effect of 7 days treatment with levocabastine on     nasal symptoms elicited by an EEC when administered once daily (QD) compared with twice daily     (BID). Also study will be conducted to investigate the superiority of effect of 7 days     treatment with levocabastine (QD and BID) on nasal symptoms elicited by an EEC in subjects     compared to placebo.   "
102166|NCT01949038|"     Diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most of     the patients. Various methods are available for sedation during this procedure. Because of     some side effects related to intravenous administration of sedatives, oral administration of     these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in     treatment of anxiety. Hence, we determine the efficacy of oral and sublingual alprazolam as     for sedation during this procedure. We hypothesize that sublingual alprazolam is more     effective than that oral form and both forms more effective than placebo in reducing anxiety     and pain/discomfort related to the procedure.   "
102167|NCT01949025|"     1. Summary           Growing evidence suggests that a significant proportion of in-hospital patient deaths          occur after serious adverse events (SAE's). Concerns have been raised that too often          patients' acute deteriorations, particularly on surgical and medical wards outside          critical care settings, are identified too late and corrective actions taken too slowly.          Many initiatives have been taken to prevent unexpected death by timely recognition,          intervention and resuscitation efforts such as Rapid Response Systems (RRS's). RRS's          have been introduced with the intention to prevent SAE's and to improve patient outcome          by facilitating early detection of warning signs for clinical deterioration. These          systems have four components (1) an afferent limb for detection and response triggering,          (2) an efferent limb with medical or nursing response to prevent deterioration (3) a          process improvement limb and (4) a governance and administrative structure. It remains          uncertain which elements of RRS's contribute most to patient outcomes such as unplanned          (re-) admission to the intensive care unit, shock, cardiac arrest and unexpected death.          In addition, previous studies found that nurse observation, assessment and communication          (afferent limb) are crucial to achieve better patient outcomes, but how to achieve          afferent limb sustainability in hospitals is not clear.           A previous study investigated 23 hospitals in Flanders (Belgium) about how nurses          observe, assess, detect and communicate deteriorating and critical patients in surgical,          medical and geriatric wards. Wide variation between hospitals was identified about          critical patient intervention procedures, strategies and Do Not Attempt Resuscitation          (DNAR) orders as well as between nurses about the use and knowledge of critical vital          signs and call criteria for physician clinical advice and support. Nurses of hospitals          with structured observation and communication protocols were better informed and          perceived their communication and collaboration with physicians more favorable in          compared to other hospitals. Based on these results conclusions and recommendations for          further initiatives were formulated. The proposed Afferent Limb and Response Method          intervention study will implement these recommendations guided by a robust scientific          research approach to offer evidence to the nursing and medical practice community.           The aim of this study is to evaluate the effect of the Afferent Limb Ascertainment and          Response Method intervention or ALARM intervention in medical and surgical nursing wards          of acute care hospitals on the prevention of SAE's such as in-hospital unexpected death,          unplanned ICU-admission and cardiac arrest.        2. Study hypothesis      Optimizing and supporting the process of observation, use and interpretation of vital signs,     detection, assessment, escalation and communication with a higher level of care in     deteriorating patients can prevent serious adverse events (in-hospital unexpected death,     unplanned ICU admission and cardiac arrest) in acute care hospitals.   "
102168|NCT01949012|"     Dentists use sedation to help patients accept difficult procedures and to relieve anxiety.     During sedation, the well-being of the patient is monitored by the dental team. When carried     out according to recognised guidelines,intravenous dental sedation is considered to be very     safe. For some patients, dental sedation is a useful alternative to general anaesthetic. It     is cheaper and has the potential to be more accessible. Oximetry(measurement of oxygen     status) is the current gold standard in dental sedation. The main risk to the patient during     sedation is a slowing of breathing due to the effects of the sedative drug. Studies from     other settings where sedation is practiced suggest that an additional monitor with     capnography facilitates early detection of depressed breathing. However, the results of     studies from other medical settings cannot be generalised to dental sedation, because of     different techniques used and the types of patients. The depth of sedation may also be vary.     For dental sedation, patients remain responsive at all times and breathe for themselves.     Capnography gives breath by breath information using a simple device placed close to the nose     and mouth. It has been recommended by several governing medical bodies that each area of     medicine, should develop its own guidelines for sedation. Therefore, there is a need to     research the application of capnography for dental sedation. The proposed study will take     place at a university hospital site. Patients will be randomly divided into two groups. Both     groups will receive sedation in the normal way. The study group will have capnography     monitoring added. The study will look for differences in breathing between the two groups.     Additional information regarding other aspects of monitoring will also be obtained. The     results from the proposed study may help to improve patient safety and change current     practice during sedation for dentistry.   "
102169|NCT01948999|"     The purpose of the study is to determine whether addition of electroconvulsive therapy to     antipsychotic treatment improves the mental health of patients with treatment-resistant     schizophrenia.   "
102170|NCT01948986|"     This is a study to evaluate the effect of renal impairment on the pharmacokinetics,     pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2     diabetes mellitus (T2DM) and in healthy participants with normal renal function.   "
102171|NCT01948973|"     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood     but recent studies have shown changes in both colonic motility and rectal sensibility. We     have previously shown IBS patients to benefit from sacral nerves stimulation. With the     present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as     suprasensory sacral nerve stimulation.   "
102172|NCT01948960|"     A study to determine whether everolimus pharmacokinetics in elderly and obese patients is     different compared to control patients.      Furthermore the investigators will investigate the relation between metabolic response     assessed with [18F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus     exposure and clinical benefit.      The investigators will explore whether dose escalation in patients who are hypothetically     underexposed will result in an increase in metabolic response.   "
102195|NCT01948453|"     The purpose of this study is to determine whether garlic in adjunct to conventional medical     treatment is effective in improving carotid intima media thickness (CIMT), Flow mediated     dilation (FMD) and plasma lipid profile or c-reactive protein of coronary artery disease     (CAD) patients.   "
102173|NCT01948947|"     Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild     traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most     debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely     clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial     magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable     chronic central pain conditions including headaches. This study aims to 1) assess the effect     of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the     neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS     with function magnetic resonance imaging (fMRI).   "
102174|NCT01948934|"     The purpose of this study is to determine the safety of use of a new therapeutic strategy for     the treatment of patients with large wounds   "
102175|NCT01948921|"     Our pilot results showed that meperidine reduce patient discomfort during EGD     (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative     agents. So the investigators target the use of meperidine on patients expected to have poor     tolerance in this study, which includ young females with high anxiety level and patients with     prior poor tolerance. The investigators test the hypothesis that meperidine improves     tolerance and alleviates discomfort for patients expected to have poor tolerance during     diagnostic EGD.   "
102190|NCT01948518|"     The purpose of this study was to investigate the acute effects of sildenafil on diffusion     capacity, a commonly performed pulmonary function test, which is used to assess the lungs'     gas exchange capability.      This study does not assess safety or efficacy of the drug. The study does not have clinical     end points. The variables studied are diffusion capacity and 6 minute walk after a single     dose of sildenafil.      This study has been completed.   "
102176|NCT01948908|"     The purpose of this study is to determine exactly how much drug volume should be administered     into each nare, so that the drug absorption can be maximized and the amount that runs out of     the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug     given intranasally. The investigators will determine this ideal volume of administration by     studying intranasal midazolam in children who require sedation to facilitate laceration     repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic     outcomes associated with each volume of administration. We will block randomize children to     receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200     microliters (mcL), 500 mcL, or 1000 mcL.   "
102177|NCT01948895|"     This multi-centred study will be conducted at two centres. The design will be an open label,     flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine     monotherapy for patients who meet diagnostic criteria for dysthymia.   "
102178|NCT01948882|"     The Essure System is indicated for women who desire non-incisional permanent birth control     (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to     evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth     control in preventing pregnancy. The Essure ESS505 System includes a design modification that     will be studied to determine if it provides immediate birth control, thereby removing the     three months waiting period required for the commercially available Essure System Model 305     to be effective.   "
102179|NCT01948869|"     The study shall explore whether treatment of atopic dermatitis is equally effective with     respect to a marketed medical device and a new medical device.   "
102180|NCT01948856|"     The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of     Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of     younger age who develop infectious diseases more frequently than other children of this age     in general.   "
102181|NCT01948843|"     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from     microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has     been used to treat patients that have cancers that require arginine. In this study, ADI will     be combined with the well known chemotherapy Doxorubicin and the safety and potential     efficacy of this combination will be explored in patients with HER2 Negative Metastatic     Breast Cancer.   "
102182|NCT01948830|"     This study was designed to evaluate the efficacy and safety of two different regimens of 0.5     mg ranibizumab given as intravitreal injection in patients with neovascular age-related     macular degeneration   "
102183|NCT01948817|"     This is an open label, single arm, and multicenter study. The study will include the     following phases. A screening phase which lasts for 4 weeks to determine patient eligibility.     This phase will be followed by a 24 week Open label treatment phase. The study treatment is     defined as deferasirox 20mg/kg BID 9Twice a day). Serum Ferritin Levels and MRI (Magmetic     Resonance Imaging) LIC (Liver Iron Concentration) will be measured to evaluate the response     to BID.   "
102184|NCT01948804|"     The comparison of effect of four different treatment protocols: Antagonist/letrozole     protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF     outcomes in poor responders undergoing in vitro fertilization; a prospective     randomized-controlled study.   "
102185|NCT01948791|"     To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate     Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration   "
102196|NCT01948440|"     Making referrals to medical and psychosocial services for substance abuse clients has proven     difficult due to lack of access to services, inadequate counselor knowledge, and lack of     motivation and skills among clients. Inflexxion is proposing the development of ASI-MV     Solutions, which will educate clients about employment, legal, psychiatric, relapse     prevention, medical, and family issues, as well as include resources and strategies for     counselors. By linking learning modules to client results on the ASI-MV, an online     interactive version of the ASI administered in treatment settings, we will be able to offer     clients important tools to address key recovery issues and encourage counselors to make     appropriate referrals to medical and psychosocial services.   "
102197|NCT01948427|"     THRIVE is an observational study that will collect information on patients with UCDs. THRIVE     will follow enrolled participants for up to 10 years. As an observational study, enrolled     patients will not be required to make any additional office visits or take any medicine     outside of normal care.   "
119515|NCT01721564|"     6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary     microvascular endothelial function.   "
102186|NCT01948778|"     Septic shock has a high mortality risk despite the availability of various treatments.     Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger     of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming     systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with     generalized vascular endothelial damage, tissue injury and multi-organ failure.      Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin.     Different extracorporeal blood purification systems are available. The oXiris™ device     comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma     cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the     membrane allows absorbing negatively charged bacterial products such as endotoxin. From an     historical perspective, filters containing AN69-based membranes have been the most commonly     used products for CRRT in the management of critically ill patients and a substantial volume     of published data exist.      Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX)     filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of     polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the     polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity.     Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating     endotoxin by adsorption.        -  Trial with medical device   "
102187|NCT01948765|"     The investigators hypothesize that the application of 30% xenon as an adjuvant to general     anesthesia with a target-controlled infusion of propofol is superior to general anesthesia     with propofol alone with respect to hemodynamic stability.   "
102188|NCT01948752|"     The current study sought to examine the effect of menu labeling on food ordering and food     consumption, including the effect of displaying calories along with other nutrients, such as     sodium, fat, and sugar, as well as in different formats, such as traffic lights.      The investigators hypothesize significant differences in the calorie amount of menu     selections and food consumption across experimental conditions. The investigators anticipate     that calorie amounts will be significantly higher in the no calorie information) compared to     each of the other 3 conditions, and significantly lower in the Traffic Light conditions     compared to calories only condition.      2) Individuals in Condition 1 (no calorie information) will be significantly more likely to     underestimate the calorie content of their meals compared to individuals in the intervention     conditions.   "
102189|NCT01948531|"     Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the     antiage activity of Gynomunal® gel after one single application on the face (short term     evaluation) and 4 weeks of repeated use twice daily (long term evaluation) by healthy female     volunteers.      It is also aim of this study to evaluate cosmetic acceptability by the volunteers and     efficacy and tolerance both by investigator and volunteers.   "
102191|NCT01948505|"     To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient     pain.      To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels     in neurocritically ill patients.      To assess the effect of an intravenous nonnarcotic pain medication on common side effects     seen in patients taking other intravenous narcotic pain medication in the neurocritical care     unit.   "
102192|NCT01948492|"     Minimal data are available on protein requirements throughout the lifespan. Currently     available recommendations are based on nitrogen balance data. The limitations of the nitrogen     balance method have been well described. Importantly, nitrogen balanced underestimates     requirements.      The current dietary reference intake (DRI) requirement for healthy adult males is based on     the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was     reanalyzed statistically by Rand et al. and he concluded that the protein requirement of     healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO,     our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and     1.2 g/kg/day (mean and RDA).      Currently there are no studies on protein requirement in the elderly. In a recent nutrition     survey conducted by national health and nutrition examination survey (NHANES), the authors     concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0     g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on     the calculations used for ideal body weight some older adults could be getting higher or     lower than requirement. There is no scientifically derived protein estimate for older adults.     Therefore there is a need to measurer protein requirement in that population.      The goal of this study therefore is to measure the protein requirement of male elderly     subjects > 75 years using the indicator amino acid oxidation (IAAO) technique.      Hypothesis:      The investigators hypothesize the protein requirement in elderly male subjects will be lower     (0.85-1.05 g/kg/day) than that established in young healthy males ( 0.93 - 1.2g/kg/day).   "
102193|NCT01948479|"     Insoles are designed to reduce increased loads and re-ulceration risk in patients with     diabetes. The investigators previous research findings suggest that an instant insole     solution may benefit some, but effectiveness is difficult to predict. The investigators     propose a feasibility study using in-shoe pressure analysis to optimise the protective effect     of insoles and footwear with the aim of reducing re-ulceration rates.      Early indications from exploratory case studies within the real world clinical setting     suggest that by implementing the investigators previous published research findings the     investigators can optimise effectiveness and reduce outcome variability of protective     footwear and insoles provided to patients at risk of re-ulceration.      However a further randomised control trial is necessary to evaluate the effectiveness of     in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The     proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic     foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear     provision or 2) Routine insole and footwear provision, and temporary insole provision with     optimisation. The findings from the feasibility study will inform protocol development for a     larger clinical trial. The results of the feasibility study will be used to strengthen a     protocol for a grant application to conduct the main RCT. A secondary output from the pilot     study will be the dissemination of findings in a peer reviewed journal and at conference.   "
102213|NCT01948219|"     The objective of this clinical study is to evaluate the feasibility, safety and efficacy of     the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.   "
102198|NCT01948414|"     The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to     investigate the cognitive process. The P300 component are accepted as electro-physiological     markers of neuropsychiatric disorders like alcoholism or drug addiction.      Recent scientific data suggest that eating disorders, leading to weight gain and obesity,     will be similar of those of drug addiction: it is the incentive sensitization theory that     implicates the dopaminergic reward system.      The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP     in obese women with eating disorders in comparison with obese and lean women without eating     disorders.   "
102199|NCT01948401|"     This interventional, open study will evaluate clinical data in relation to biomarkers in     patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma.     Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose     of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in     a future placebo-controlled intervention study designed to measure the steroid-sparing effect     of lebrikizumab.   "
102216|NCT01948180|"     To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients     with aggressive EBV positive extranodal NK/T-cell lymphoma   "
102200|NCT01948388|"     The purpose of the study is to evaluate the effect of the utilization of two doses of     corticotrophin ( ACTH) as a treatment in patients with early onset rheumatoid arthritis as an     alternative to conventional steroid therapy by evaluating the change from baseline in the     clinical findings as well as the structural findings on Magnetic Resonance Imaging (MRI).     Corticotrophin (ACTH) may prevent the well documented structural progression damage in RA     patients using disease-modifying antirheumatic drug (DMARD) therapy alone.   "
102201|NCT01948375|"     Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have     applied a new kind of placebo needle in large scale acupuncture clinical trials, which named     as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials,     this pragmatic placebo needle shows several advantages: the outlook closer to traditional     acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and     more economical. However, its blinding effect is not yet validated. The primary objective of     this trial is to validate the blinding effect of the new pragmatic placebo needle; the     secondary objective is to explore factors influencing the blinding effect of the placebo     needles.   "
102202|NCT01948362|"     To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy     male volunteers.   "
102203|NCT01948349|"     The advantage of self-ligating brackets on periodontal health has yet to be determined. In     addition, the utilization of tongue scraping as an adjunct to traditional oral hygiene     measures has yet to be studied in orthodontic patients. The aim of this study is to evaluate     the effect of bracket type on plaque accumulation and also the impact of the appliance on     oral malodor. In addition, the effect of tongue scraping on halitosis will be studied in     patients undergoing orthodontic treatment. We hypothesize that self-ligating brackets will     harbor less plaque than normal brackets, that tongue scraping will significantly decrease     halitosis in patients undergoing orthodontic treatment and that patients with self-ligating     brackets will exhibit less halitosis as measured by halimeter.   "
102204|NCT01948336|"     The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage     renal function.   "
102205|NCT01948323|"     The purpose of this study is to investigate whether overweight but not obese pregnant African     women having unlimited access to a health education-information technology (IT) based     intervention package gain weight within the acceptable range of 8-12 kg during the pregnancy     period.      Therefore, we hypothesize that unlimited access to health education via an IT-based     intervention package has the potential to reduce the onset of obesity in African pregnant     women.      To date (Aug 2015), 95% of patients have been recruited, 1320 potential subjects have been     screened and 150 enrolled into the study   "
102206|NCT01948310|"     The primary objective is to assess whether the increased angina threshold on ranolazine and     subsequent higher training intensity will result in improved exercise tolerance and oxygen     consumption; and greater than that observed with exercise training on placebo. The study team     anticipates the chronic exercise improvements with ranolazine will be incrementally higher     than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key     secondary objectives include the acute ranolazine and chronic exercise plus ranolazine     effects on total daily energy expenditure (TDEE) and angina-related quality of life.   "
102207|NCT01948297|"     This study is primarily designed to assess the safety and the tolerability of Debio1347     (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of     the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment     does not exist or is not indicated.      The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate     the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally     administered daily to these patients, in order to determine the recommended dose.      The main objective of Part B is to evaluate the safety profile at the recommended dose, in a     larger cohort of these patients.   "
102208|NCT01948284|"     This prospective, randomize, controlled trial will compared maximal to half-maximal suction     pressure applied during water exchange in patients undergoing minimally sedated colonoscopy.     We test the hypothesis that maximal suction pressure is more efficient and causes shorter     insertion time.   "
102209|NCT01948271|"     The purpose of this research study is to better understand whether trichuris suis ova (TSO)     ingested orally may be safe and effective in the treatment of psoriasis.   "
102210|NCT01948258|"     This study will assess the use of the new Clearblue Advanced Fertility Monitor for one     menstrual cycle in a home setting by female volunteers seeking to get pregnant.   "
102211|NCT01948245|"     The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100     and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in     patients with intestinal failure and a central venous access device for home parenteral     nutrition.   "
102212|NCT01948232|"     The purpose of this study is to evaluate the feasibility of conducting a medical intervention     trial in childhood cancer survivors with early echocardiographic evidence of cardiac     remodeling.   "
102215|NCT01948193|"     The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV-     Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14     weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface     antigen (HBsAg) serology negative in India.      Primary Objective:        -  To evaluate the immunogenicity of the study vaccine in terms of seroprotection          [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae          type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for          pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one          month after the third dose.      Secondary Objectives:        -  To further describe the immunogenicity of the study vaccine, before the first dose and          one month after the third dose.        -  To describe the safety after each and any doses of the study vaccine.   "
102217|NCT01948167|"     This project, which will innovatively combine risk factor research and evidence-based     prevention programs, will advance knowledge on personalized approaches to prevention that may     be able to betterbend trajectories of depression that surge throughout adolescence. A     randomized controlled trial will deliver equal doses of IPT-AST and CWS for the prevention of     depression in adolescents. These two programs are designed to address distinct risk factors     for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A     total of 210 participants across two sites, University of Denver and Rutgers University, will     be stratified on cognitive and interpersonal risk and randomized to the two conditions. The     goals of the study are to (1) demonstrate that prevention programs can modify depression     trajectories among youth by examining within person changes in trajectories over time (three     years before and three years after the prevention programs) and by comparing trajectories of     prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention     approach to bending depression trajectories by matching and mismatching youth to either CWS     or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression     trajectories and test whether the prevention programs operate via their hypothesized     processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament     may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention     programs after 3-years of prospective naturalistic data collection, this study will     contribute essential data on personalized medicine and altering developmental trajectories of     first-onset depression.   "
102218|NCT01948154|"     Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions     that cause physical disability in human development. It is not infrequently to note     concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many     studies have documented Cerebral palsy is associated with a variety of neuromotor disorders     that frequently affect the speech production system. The speech function impairment varied     widely due to different severity of diseases involved. The investigators hypothesize such     impairment of speech function may affect degree of social participation and eventually the     quality of life (QoL).   "
102219|NCT01948141|"     This phase II trial studies how well nintedanib works in treating patients with advanced     non-small cell lung cancer who have failed up to two previous chemotherapy regimens.     Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
102220|NCT01948128|"     This protocol is a randomized, phase 2 window of opportunity trial assessing the biological     effects of short term oral vitamin D administration on breast cancer clinical and     translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage     of the current wait times (2-8 weeks) for breast cancer surgery as a window of opportunity     to rapidly assess biological changes with vitamin D intake.   "
102221|NCT01948115|"     The variety of breech presentation at term is about 3-4% of all births. Our study aims to     assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some     patients algic or relaxed, the success rate seems more important.      It's a single blind prospective randomized controlled study, comparing success rate of ECV     after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).      We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we will     give the patient a satisfaction questionnaire. We compare the success rate of ECV as primary     outcome.   "
102222|NCT01948102|"     The purpose of the project is to obtain skin and adipose tissue samples from patients with     ALS to develop new diagnostic and prognostic markers of the disease. These samples will be     obtained when percutaneous endoscopic gastrostomy (PEG) is performed as part of their     standard of care. Skin and adipose tissue samples will also be obtained from disease control     subjects who require a PEG as part of their standard of care.   "
102223|NCT01948089|"     This project will investigate the effectiveness of an intensive and focused working memory     training program for chronic stroke patients. The investigators hypothesize that working     memory training will be an effective method of improving working memory and related cognitive     and behavioural functions in this population.   "
102224|NCT01948076|"     The 40 resident study subjects will be randomized to either receive a training session on use     of a pocket-sized ultrasound or to receive training on physical exam skills. Following these     sessions the subjects will have the opportunity to practice their skills during clinical     rounds at BWH inpatient and outpatient settings. Four weeks after the training session all     study subjects will take part in an assessment of their diagnostic skills. During this     assessment they will be asked to complete an exam on a patient subject. Those randomized to     the ultrasound group will be allowed to use their devices while the control group will use     the traditional physical exam. Following the exams, resident study subjects will be asked to     indicate whether they detected any of the following abnormalities on their exams: pleural     effusion, hepatomegaly, cirrhotic liver, splenomegaly, ascites, aortic stenosis, mitral     regurgitation, right atrial pressure, abdominal aortic aneurysm, deep vein thrombosis.     Resident study subjects will also complete a questionnaire about the physical exam and use of     the ultrasound. Prior to the assessment, all patients will undergo ultrasound by an attending     radiologist, and these results will serve as the gold standard for our study.   "
102225|NCT01948063|"     This study aims to determine if Ubiquinol (reduced form of COQ10) will attenuate     mitochondrial injury and decrease inflammatory response in patients suffering from sepsis.   "
105469|NCT01905579|"     The purpose of this study is to compare flaremetry readings with the protein content of the     aqueous humor and the clinical grading of flare.   "
102226|NCT01948050|"     This is a pilot study designed to collect preliminary data on safety and efficacy of     transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who     developed neuropathic pain in the affected area after a surgical intervention, radiation     therapy, or chemotherapy to treat the disease.   "
102227|NCT01948037|"     The purpose of the study is to investigate whether the hydrotherapy are effective in against     pain and other symptoms in diabetes-induced LEAD.   "
102228|NCT01948024|"     This is a Multiple-dose, steady state, three-way reference-replicated crossover study.      The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine     10mg sublingual tablets.   "
102229|NCT01948011|"     To investigate the Racecadotril pharmacokinetic linearity after single oral administration of     10, 30 and 60 mg as a suspension.      To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension)     versus the reference sachet formulation (granules)   "
102230|NCT01947998|"     This prospective cohort study will provide information about: characteristics of Rivaroxaban     use in patients who are prescribed Rivaroxaban for the first time compared to patients who     are prescribed Warfarin for the first time, the occurrence of intracranial haemorrhage,     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.   "
102231|NCT01947985|"     This prospective cohort study will provide information about: characteristics of Rivaroxaban     use in patients who are prescribed Rivaroxaban for the first time compared to patients who     are prescribed Acenocoumarol for the first time, the occurrence of intracranial haemorrhage,     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.   "
102232|NCT01947972|"     Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a     high percentage of amino acids from the first day of life in order to achieve normal     neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased     visceral fat) that this type feeding, in conjunction with complexity of prematurity, is     likely to cause. Current study aims to investigate is whether individualized fortification of     breast milk protein, based on the mother's milk protein content and targeting the recommended     daily protein requirements, is associated with better nutrition, growth, biochemical and     endocrine markers associated with the nutrition of preterm low birth weight neonates,     compared to the standard fortification of human milk.   "
102233|NCT01947959|"     This prospective cohort study will provide information about: characteristics of Rivaroxaban     use in patients who are prescribed Rivaroxaban for the first time compared to patients who     are prescribed Phenprocoumon for the first time, the occurrence of intracranial haemorrhage,     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.   "
102234|NCT01947946|"     The purpose of this study is to determine whether Benralizumab reduces the number of asthma     exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.   "
102235|NCT01947933|"     The main purpose of this study is to evaluate the safety of the study drug known as     mirikizumab. The study will investigate how the body processes the study drug and how the     drug affects the body. The study will last about 3 months for each participant.   "
102236|NCT01947920|"     The purpose of this study is to determine the safety and tolerability profile of tramadol     hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported     by currently available toxicology and clinical data (200 mg to 600 mg per day).   "
102237|NCT01947907|"     A six month study of ACP-001, a long-acting growth hormone product, versus standard human     growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone     (hGH) will be given on a daily basis. The primary aim is to demonstrate safety,     pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is     the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH     treatment group.   "
102238|NCT01947894|"     The purpose of this study is to assess the long term treatment outcomes of Growth Hormone     treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine     the relationships between clinical status, dosage schedule and response to Genotropin     treatment.      This study will also contribute to our knowledge of adult Growth Hormone Deficiency,     including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.   "
102239|NCT01947881|"     The purpose of this study is to identify Diabetic Macular Edema (DME) characteristics in eyes     that show different response to treatment with anti-VEGF (vascular endothelial growth factor)     injections of Lucentis.   "
102240|NCT01947868|"     This is an open-label, non-interventional, single-arm, multicenter study in a real-world     population to assess the clinically symptom improvement and quality of life (QoL) in patients     with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as     the first-line treatment.      The Primary Objective is to estimate symptom improvement rates in patients with locally     advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the     first-line treatment. A clinically meaningful improvement is defined as an increase from     baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.   "
102241|NCT01947855|"     To evaluate the efficacy of empagliflozin administered orally once daily in postprandial     glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as     mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic     control on no antidiabetic treatment.   "
102242|NCT01947842|"     This research study is to see if smartphone applications help college women remember to take     birth control better than pharmacist consultation alone. Patients will participate in this     study for 6 (six) months. The study will have two groups. Patients will be randomly assigned     to one group or the other. The control group will be counseled by the pharmacist on the     importance of taking birth control as prescribed. The study group will get the same     counseling, but will also be set up to receive reminders to take medication on a smartphone     application called Dosecast.   "
102264|NCT01947556|"     The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of     the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by     jet-injection to that of the same insulin injected with a conventional pen in the management     of hyperglycemia in subjects with diabetes   "
109864|NCT01847950|"     The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the     frequency and constistency of stools in subjects with functional constipation   "
102243|NCT01947829|"     Session-to-session variations in delivered Kt/V that may cause failure to achieve the     prescribed dialysis dose may be significant in regular clinical practice. To date, this is     not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of prescribed     dialysis dose may be caused by low effective treatment time, vascular access dysfunction,     hemodynamic stability, blood pump speed, membrane influences, lab value variability or others     which may vary from session to session. Patients close to recommended target limits of     dialysis dose may thus be randomly attributed to be adequately or inadequately dialyzed.     Therefore, in the literature, use of average Kt/V values is recommended.      Adimea allows easy Kt/V determination in every session and thus documentation of the monthly     achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of     session-to-session variability as well as knowledge of dialysis dose monitoring at every     dialysis may enhance and secure delivery of adequate dialysis.      The main objective is the estimation of the pooled within-patient SDs (standard deviation)     for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of     Kt/V>1.2 delivery as well as its potential causes will be assessed. spKt/V target achievement     is assessed by monitoring dose by Adimea at every dialysis. This shall demonstrate that     session-to-session variability can be decreased with usage of Adimea.   "
118783|NCT01731145|"     The purpose of this study is to record and measure tremor using portable six-axis (tri-axial     accelerometer and tri-axial gyroscope) motion sensing system.   "
102244|NCT01947816|"     This investigation will be conducted to obtain the following information regarding the use of     Humira 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Ulcerative Colitis.        1. Unknown adverse reactions (in particular, clinically significant)        2. Incidence and conditions of occurrence of adverse reactions in clinical practice        3. Factors likely to affect the safety and effectiveness   "
102245|NCT01947803|"     The purpose of this study will be to evaluate the safety and treatment response of     paliperidone palmitate administered to Chinese patients with schizophrenia.   "
102246|NCT01947790|"     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,     mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2     diabetes is understandably directed toward treating coronary artery conditions. However there     are other treatable culprits in these patients.      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even     in the absence of hypertension. It is a strong predictor of cardiovascular events and     all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality     than either multivessel coronary disease or impaired left ventricular function. Regression of     LVH has been associated with an improved prognosis, independent of change in blood pressure     (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD might will     be reduced if we can find novel therapies to regress LVH.      Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can     regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this study,     we will treat patients with pioglitazone, and we will also metformin as control.   "
102247|NCT01947777|"     To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the     pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when     administered with rifampin in healthy subjects   "
102248|NCT01947764|"     In the resource-limited settings where most HIV-infected children live, neither the most     effective strategies to inform children of their HIV status, nor the impact of disclosure is     well understood. This team's long-term goal is to provide evidence to improve the chronic     disease management of HIV-infected children in resource-limited settings. The purpose of this     study is to assess the effect of a patient-centered intervention guiding disclosure to     HIV-infected Kenyan children using a randomized trial comparing the intervention to routine     care. The primary endpoint will be probability of disclosure among children, with secondary     endpoints of adherence, clinical outcomes, psychological distress and social outcomes. This     work will be done within the Academic Model Providing Access to Healthcare (AMPATH) which     currently cares for almost 120,000 adult and pediatric HIV-infected patients in 25 clinics in     Kenya. We will utilize the excellent infrastructure of this academic partnership to provide     the first comprehensive assessment of the physical, psychological, and social impact of     disclosure for HIV-infected children in East Africa. We will evaluate the impact of an     intensive disclosure intervention by pursuing these specific aims: Aim 1: Expand and modify     an existing pediatric HIV disclosure intervention used in Kenya to include patient-centered     components; Aim 2: Perform a randomized trial to compare the impact of clinic implementation     of the culturally adapted, pediatric disclosure intervention on the prevalence of disclosure     and on the medical, psychological, and social outcomes for HIV-infected Kenyan children ages     10-15 years compared to children exposed to standard clinical care. The usual care control     arm will have disclosure training for all clinicians, disclosure chart materials, and an     existing protocol to implement disclosure for patients over 10 years. The disclosure     intervention will consist of patient-centered materials to guide disclosure, including     videotaped narratives; disclosure counselors; post-disclosure child support groups; and the     usual care resources. The central hypothesis is that an intensive disclosure intervention     based on culture-specific qualitative work and a patient-centered approach will allow for     disclosure in which more children know their HIV status at younger ages, and they also have     improved medication adherence, improved medical outcomes, unimpaired psychological outcomes,     and no increase in experienced stigma over time.   "
102249|NCT01947751|"     Central venous catheter(CVC)-related infection is an inherent complication of this device     that should be treated promptly. However, there are doubts about the need for the immediate     withdrawal of CVC while there is still no confirmation of such infection. The aim of this     study is to compare the resolution of CVC-related infection, testing two approaches:     catheter´s early exchange, when the possibility of related sepsis is considered, versus the     maintenance of the CVC and early antibiotic therapy until the infection is confirmed.   "
102250|NCT01947738|"     Psoriasis is an inflammatory autoimmune disease that might be controlled by a cathepsin S     inhibitor like VBY-891.   "
102251|NCT01947725|"     The purpose of this study is to examine whether behavioral activation as an adjuvant to     standard smoking cessation treatment improves smoking cessation outcomes among veterans with     PTSD relative to a comparably intense combination of standard smoking cessation treatment +     health and smoking education. It is expected that behavioral activation will produce more     successful results than health and smoking education when paired with standard smoking     cessation treatment.   "
102252|NCT01947712|"     Peripheral arterial disease (PAD) is a clinical setting characterized by an exceptionally     high risk for cardiovascular events. Oxidative stress seems to play a role in impairing     flow-mediated dilation (FMD) and contributing to atherosclerosis in patients with PAD. Cocoa     seems to exert artery dilatation via oxidative stress inhibition.      OBJECTIVES: To investigate whether in PAD patients, dark chocolate elicits artery dilatation     via down-regulation of NOX2, the catalytic core of NADPH oxidase.   "
102265|NCT01947543|"     The aim of this study is to screen a well characterized patient population with ventricular     tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator     (ICD) for mutations in the calmodulin genes.   "
102253|NCT01947699|"     Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is     called gestational diabetes, and it places both mom and baby at risk for complications.     Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is     a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease     the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have     described a difference in the way and how well the drug works compared to when used outside     of pregnancy.      Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to     lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth)     blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not     FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in     pregnancy.      This research study will help us learn more about the variations in blood sugar levels in     women with diabetes in pregnancy who are taking glyburide and how changes in the timing of     when the glyburide is taken would affect blood glucose levels. The goals of this study are:        -  To find the how glucose changes throughout the day in women with diabetes in pregnancy          receiving glyburide        -  To learn the effect of changing the time of taking glyburide on glucose levels        -  To learn the effect of changing the time between glyburide doses on glucose levels        -  To see if insulin is secreted the same throughout the day in response to a morning dose          of glyburide.   "
102254|NCT01947686|"     The purpose of the study is to determine the survivorship rate of robotically guided isolated     patellofemoral implants at 2, 5 and 10 year postoperative.   "
118784|NCT01731132|"     Knowledge about the impact on quality of life of women initiating IUD in the Spanish     population at baseline and after 12 months of use.   "
102255|NCT01947673|"     Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due     to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during     hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of     cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH, and     whether mindfulness meditation might improve BP during dialysis in these patients. The     investigators will first determine if increased adrenaline levels during volume removal     contributes to IDH. The investigators will then determine lack of suppression of adrenaline     levels in the setting of a high BP also contributes to IDH. This will be done by manipulating     blood pressure by using small amounts of vasoactive drugs, and determining if an appropriate     response in adrenaline levels occurs. Lastly, the investigators will determine if an     intradialytic mindfulness meditation program improves BP and adrenaline levels in ESRD     patients with IDH.   "
102256|NCT01947660|"     This study aims to assess the safety of using continuous regional anesthesia for     post-operative analgesia during septic limb orthopedic surgery.      The study hypothesis is that continuous regional anesthesia would not induce septic     complication in the operated limb and could improve post-operative recovery.   "
102257|NCT01947647|"     Cognitive behavioral therapy (CBT) is a brief, efficient, and effective psychotherapy for     individuals with depressive and anxiety disorders. However, CBT is largely underutilized     within Veteran Affairs Medical Centers (VAMCs) due to the cost and burden of trainings     necessary to deliver the large number of CBT protocols. Transdiagnostic CBT, in contrast, is     specifically designed to address numerous distinct disorders within a single protocol. This     transdiagnostic approach has the potential to dramatically improve the accessibility of CBT     within VAMCs and therefore improve clinical outcomes of Veterans. The proposed research seeks     to evaluate the efficacy of a transdiagnostic CBT by assessing clinical outcomes and quality     of life in VAMC patients with depressive and anxiety disorders throughout the course of     treatment and in comparison to an existing evidence-based psychotherapy, behavioral     activation treatment.   "
102258|NCT01947634|"     Prospective, observational cohort study to investigate the prevalence of sleepiness and     sleep-related breathing disorders in patients with Fabry disease (FD). For this, an Epworth     Sleepiness Score (ESS) and ambulatory overnight respiratory polygraphy (oRP) is obtained in     all subjects.   "
102259|NCT01947621|"     This is a multicenter, multinational, prospective and retrospective, observational study of     patients with Takotsubo cardiomyopathy (TTC).      Data on natural profile (demographical characteristics, clinical phenotype, laboratory     values, electrocardiography parameters, echocardiography parameters, coronary angiography     parameters, medication) and outcome are systematically collected.      Our aim is to gain a better insight into the clinical profile and pathophysiology of TTC.   "
102260|NCT01947608|"     Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 to     patients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except in     countries where ALK inhibitors are not approved or available. The protocol will further     evaluate the safety of LDK378 in patients with ALK(+) NSCLC.   "
102261|NCT01947595|"     The purpose of this prospective randomized multicenter intervention study is to determine     whether in the prevention of Diabetes an intensified lifestyle intervention is superior to a     conventional lifestyle intervention in high risk non-Responder subjects. Further, the     intensive phenotyping to determine subgroups with an increased risk for diabetes enables an     individualized prevention and therapy of type 2 diabetes mellitus.   "
102262|NCT01947582|"     The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the     spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality     of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals     who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters     2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3.     Individuals who are fit with an AFO will demonstrate improvements in muscle firing     profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements     in quality of life.   "
102263|NCT01947569|"     Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired     dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type     I Diabetes Mellitus (T1DM) patients. Efficacy measures will be collected and summarized.      Phase IIA will evaluate the safety and efficacy of 3 randomized treatment groups in new onset     T1DM patients to assess if the antisense DNA-treated co-stimulation-impaired immunoregulatory     dendritic cells (iDC) will safely preserve and/or increase B-cell mass resulting in     improvement and/or normalization of blood glucose levels and glycated hemoglobin A1c.   "
102268|NCT01947504|"     The objective of the study is to implement and measure the efficiency of a standardized acute     and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety -     Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The     ultimate goal is to have patients be re-integrated to their activities faster with lesser     symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1)     Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms,     sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine     a model of outcome prediction following mild TBI.   "
102269|NCT01947491|"     The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for     topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to     Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.   "
102271|NCT01947465|"     Backgound and relevance of the project:      Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of     contracting infections. The increased risk can be attributed to the immunological disorder     itself, as well as to the immunosuppressive treatment. Vaccination against many infections is     recommended in this patient group. However, the immunogenicity of vaccines may be reduced and     may also be influenced by the administered treatment. Potential reactivation of the     underlying disease triggered by vaccination is another important concern.      From the patients' and public health perspectives, an important task of physicians is giving     advice on vaccines. Completing this task is often difficult, because data on the     immunogenicity and safety of vaccines in these patient groups are scarce, especially with     regard to treatment with new immunosuppressive medications, such as biological agents. Lastly     and importantly, due to new therapeutic options, health among AIIRD patients has considerably     improved and an increasing number of patients undertake overseas travel activities requiring     additional vaccinations. In this context, reliable advice with regard to vaccinations is     almost impossible, because for most travel vaccinations the immunogenicity and safety profile     is unknown.      Research addressing the immunogenicity and safety of vaccines in different autoimmune     inflammatory diseases treated with different immunosuppressive medications is urgently needed     to allow giving evidence based vaccine advice.      In this observational study the immunogenicity and safety of tetanus booster and hepatitis A     vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a     function of the underlying disease and the possible influence of commonly used     immunosuppressive drugs on the immune response will be studied.      Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of     the most frequently recommended vaccinations, and the effect of a booster vaccination can be     addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their     importance, only very limited data are available for tetanus and hepatitis A vaccine in this     patient group. By focusing on these vaccines the study will lead the way to the evaluation of     further vaccines.      The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are as     immunogenic and safe in AIIRD patients as in healthy controls.   "
102272|NCT01947452|"     Chicago's Department of Family and Support Services will be providing summer employment and     social-emotional skill training to youth over the summer of 2012. The investigators are     partnering with them to evaluate the effects of the program. The investigators will track     applicants to the program through existing administrative databases to assess the short- and     long-term effects of the government's program. The investigators hypothesize that the program     will decrease violence involvement and criminal activity, increase schooling engagement, and     increase future employment outcomes.   "
102273|NCT01947439|"     The risk of restenosis in the treatment of coronary artery disease has significantly lessened     thanks to the introduction of Drug eluting stent.      Yet, debates on the efficacy and safety of stents in complex lesions or patients have been     circulated.      Recently, PCI in multiple lesions is universally performed with the development of effective     stents in various kinds in the clinics.      However, a randomized study is rare for multi-vessel coronary artery disease in real     procedural environments.      The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting     stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.   "
102274|NCT01947426|"     In the present study, we evaluate the effect of the mother suplementación with DHA during the     gestation and lactation on diverse aspects of the development of newborn. The effect on the     oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development     was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last     3 months of pregnancy and the whole lactation. In addition the women will divide in two     groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects     on the development of the newborn child; whereas another group will receive a placebo.     Different samples of blood of the mother and of mother milk will be taken and we will     correlating her lipidic profile with the brain development of the newborn child, evaluated by     different tests.   "
102275|NCT01947413|"     The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor     function within each patient's prognostic potential, preventing the development of secondary     conditions that impact life-long health, and promoting patient's participation in their     lives. In addition to employ clinical measures after treatment, usual outcome measures     employed in the intervention studies included movement kinematics (spatio-temporal     characteristics of movements). Recent reports have suggested repetitive transcranial magnetic     stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with stroke. A novel     rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS (iTBS) and     continuous TBS (cTBS), that modulates human cortical excitability differently. However, there     is lack of literatures in verifying the treatment effect by the integration of clinical and     kinematic analysis. Until now, there are no conclusive results regarding optimal rTMS     protocol, such as stimulating pattern and for patients with stroke. Additionally, few studies     investigate the possible clinical characteristics of patients with stroke that may influence     the effects of various treatment protocols proposed in this project.   "
102276|NCT01947400|"     Patient satisfaction is an important aspect of care and is gaining increasing importance as a     measure of Healthcare quality. Tools for improving physician-patient communication are     available but have not yet been tested in the Hospital setting. The purpose of this project     is to determine if training in AIDET (Acknowledge, Introduce, Duration, Explanation, Thank)     communication method improves physician-patient communication. Patient satisfaction data will     be compared to historical controls using modified HCAHPS (Hospital Consumer Assessment of     Health Plans Survey) as the primary outcome measure. In addition, a validation of delivery of     AIDET communication will be accomplished through administration of questionnaires to     patients.   "
102277|NCT01947387|"     This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin     sheet bilayer or single layer products for complex soft tissue reconstruction of lower     extremity diabetic wounds compared to other treatments. Participating sites will collect     information for all patients who received Integra, free flap, local tissue flap, or negative     pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index     procedure, with index procedure being defined as the application of Integra, free flap, local     tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for     inclusion.   "
102278|NCT01947374|"     This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte     implantation procedure compared to the microfracture procedure in the repair of symptomatic     cartilage lesions of the knee. Eligible patients were asked for informed consent     preoperatively and randomised for chondrocyte implantation of microfractures. Those patients     allocated to the chondrocyte implantation group will be harvested at time of first     arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament     reconstruction, or malalignment corrected. The patients allocated to microfracture will be     treated at the time of the only arthroscopic procedure. Both groups will have the same     rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging     will be performed as main outcomes.   "
102279|NCT01947361|"     Study of heterogeneity in associations between heart rate and the initial presentation of 12     cardiovascular diseases.   "
102282|NCT01947322|"     Leukemia cells can be killed by natural killer (NK) from HLA-I mismatched donor. The proposed     study plans to realize an adoptive anti-leukaemic immunotherapy by infusion of HLA-I     mismatched NK cells to treat poor prognosis acute myeloid leukemia patients. NK cells will be     selected from HLA mismatch familial donor peripheral mononuclear cells by purification     protocol. Before NK-infusion, patients received immunosuppressive chemotherapy.   "
102283|NCT01947309|"     The primary objective of this study is to document efficacy and safety data in a real-world     setting of Chinese multiple myeloma patients who have received at least one prior therapy     treated with REVLIMID (lenalidomide).   "
102284|NCT01947296|"     The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term     of early or unforeseen recourse to the hospital for adverse events.   "
102285|NCT01947283|"     The purpose of this study is to learn more about how patients and healthcare providers     interact in order to improve shared decision making. The investigators plan to test an     intervention with two separate educational components—one for patients and one for     providers—designed to encourage patients to ask questions and increase their level of     involvement in their own care, while simultaneously training providers to be more receptive     to patients' questions and concerns. Patients in the intervention group will receive three     short (30-45 minute) trainings focused on developing and asking questions and will be     interviewed three times over the course of the intervention to see how it has affected the     quality of their care. Providers receiving the intervention will participate in three     separate trainings, including a 12-hour group workshop, an additional two hour training, and     six hours of individual instruction, including personalized feedback based on three     audio-recorded patient visits. Previous studies looking at patient engagement and involvement     in decision-making have shown that increased engagement is linked with improved outcomes, but     that providers are sometimes not prepared to develop a collaborative relationship with     patients. The investigators think that training both patients and providers to work together     and communicate more effectively will improve quality of care and increase patient     satisfaction more than interventions that focus on only one side of the clinical encounter.     One of the major goals in studying patient-provider communication is to improve shared     decision-making and see how it contributes to racial and ethnic disparities in mental health     care, since minority patients have been shown to be less involved in care and have been shown     to be perceived and treated differently by providers.   "
102286|NCT01947270|"     Drug prescription is a fundamental component of care for the elderly. Even if drugs are a     chance for the older patient, because of changes in pharmacological, pharmacokinetic and     pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks     associated with drug prescription, particularly those associated with potentially     inappropriate medication (PIM), are increased in the elderly.      We suppose that many of hospitalized elderly have at least one prescribed medication without     valid indication. Conversely, many diseases are currently undertreated in elderly patients:     e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of     patients. Moreover, PMI prescription is associated with an increased of morbidity, mortality,     risk of drug-related adverse events, utilization of health care system, care costs and     impairment of quality of life. Thus, optimization of drug prescription is a major concern for     improvement of the quality and safety of care in elderly.      The investigators' hypothesis is that a multidisciplinary program entitled Optimisation de     la Prescription MEDicamenteuse (Optimization of drug prescribing) focused on drug     prescription optimization including a physician training to the specificity of the drug     prescription in the elderly and a checklist allowing an adapted and standardized     pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in     short-term medical and geriatric care departments.   "
102287|NCT01947257|"     The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care     to estimate right ventricular after load. The reference technique for this measure is the     right catheterism which is an invasive technique. It is possible to estimate the pulmonary     artery pressure by using transthoracic echocardiography (TTE) which allows, using the     continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The     measure of the TRvmax can however be difficult for intensive care patients with little     echogenicity or impossible for those having no tricuspid leak. The evaluation of the     tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks,     one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE.     However, the data of the literature are controversial on this method and it was not validated     in mechanically ventilated intensive care patients.      The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX     (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP     by transesophageal ultrasound and the direct measure of the pulmonary pressures by right     catheterization, in ventilated patients already monitored with a catheter in the right     cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the     correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism     which serves as reference technique.   "
102288|NCT01947244|"     The purpose of this randomized controlled trial is to examine whether evidence-based home     visiting programs enhanced by doula services have effects on positive parenting practices,     breastfeeding, and child and maternal health outcomes.   "
104553|NCT01917630|"     To determine the effects of 12 weeks administration of different dose levels of ALV003 on the     mucosal lining of the small intestine and symptoms in celiac disease patients.   "
102289|NCT01947231|"     Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will     be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR)     with standard manual physical therapy on with respect to pain, function, kinesiophobia, range     of motion, perceived effect, and satisfaction.   "
102328|NCT01946724|"     The purpose of this study is to study whether percutaneous chronic total occlusion (CTO)     revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting,     guidewire, and catheter, improves a patient's quality of life and their left ventricular     function, reduces angina severity, and improves long-term survival.   "
102329|NCT01946711|"     The study should create data for the selection of a clinically relevant primary endpoint to     assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the     therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the     selected parameter should allow a correlation between an objective methodology and the     clinical outcome of the study patients.   "
102290|NCT01947218|"     Asthma and COPD are characterized by an accelerated decline in lung function associated with     incompletely reversible airflow obstruction. This could be the result of lung structural     changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum     of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the     remodeling is characterized by mucus cells hyperplasia, overproduction of mucus, and     physicochemical, biological and immunological changes. Clinically, this mucus overproduction     is reported by patients as the clinical symptom called chronic bronchitis. Generally, it     develops at a bronchiolar level where it is responsible for the progression of these     diseases. There is a paradox, because the intrinsic properties of mucus seem rather     beneficial so fighting against it may not be really wise at long-term. Especially its     defensive effect against microbial agents which remains poorly explained. Currently, no     treatment aims to reduce the production of mucus and mechanisms leading to such an     overproduction are poorly understood in severe asthma and COPD. The identification of new     targets to treat this overproduction of mucus in COPD is therefore of major interest.      In view of current knowledge, inflammatory mediators and signal transduction leading to     increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL     -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways     seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2   "
102291|NCT01947205|"     Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen     trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine     on curettage procedure.   "
102292|NCT01947192|"     This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in     etched dentin on the retention of noncarious cervical lesions restorations.      A randomized controlled split-mouth and blind trial will be carried out. Patients with at     least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned     according the type of teeth (incisors, canine or pre-molars) into two groups: control or     experimental group (application of 2% CRX for 60 seconds after the acid etching procedure).     Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper     Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture     instructions, by previously trained operators. The restorations will be evaluated by a     calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World     Dental Federation (FDI) criteria. The outcome is retention of the restoration.   "
102293|NCT01947179|"     The purpose of this study is to test the effectiveness and usability of a computer-based     treatment for mood and anxiety relevant risk factors. The target of the treatment is related     to cognitive stress, which has been shown to be associated with several negative mental     health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress     Disorder.   "
102294|NCT01947166|"     The Whipple procedure is associated with increased readmission rates for infection,     pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop     an evidence based perioperative nutrition plan to improve patient outcomes. The study has two     specific aims including evaluation of feasibility of implementing an evidence based     perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a     standard perioperative nutritional plan on primary outcome of readmission rate and secondary     outcomes of readmission cause, length of stay for initial hospitalization and/or readmission,     post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed     gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI,     albumin, pre-albumin, and method of oral intake). Categorical variables including readmission     rate, readmission cause, post-surgical complications and nutritional status will be compared     by chi-square test between intervention and control group. Length of stay for initial     hospitalization and readmission will be compared by non parametric Wilcoxon test between two     groups. Descriptive statistics will be used to describe the sample. There are no risks to the     study participants.   "
102295|NCT01947153|"     The objective of the current study is to demonstrate bioequivalence of two 2.5 mg     linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination     of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.   "
102296|NCT01947140|"     This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are     in patients with lymphoid malignancies and to determine the dose of the combination of drugs     that is safest. If the combination is determined to be safe, the study will continue accrual     patients with peripheral T-Cell lymphoma (PTCL).   "
102297|NCT01947127|"     To investigate the role of initial venous lactate in predicting the severity progression to     overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock who     suspected to have acute infections.   "
102325|NCT01946763|"     The recovery and emergences from anesthesia is a critical phase. Previous studies focused on     pharmological and anesthetics techniques to improve the quality of this stage (duration,     complications).      In this study, our first aim is to test the impact of pre operative education on the post     operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.   "
104554|NCT01917617|"     The objective of this study is to evaluate the safety and feasibility of oral rehydration     therapy for short hydration in patients with biliary tract cancer who will undergo the     chemotherapy including gemcitabine and cisplatin.   "
102298|NCT01947114|"     Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to     remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy.      Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy     were included. After midazolam premedication, remifentanil infusion 1 µg/kg/min was started     and patients were randomly allocated to receive either propofol (Group P) or ketamine (Group     K) and mivacurium for muscle relaxation. Anesthesia was maintained with remifentanil infusion     1 µg/kg/min and bolus doses of propofol or ketamine. After rigid bronchoscopy remifentanil     0.05 µg/kg/min was maintained until extubation. Hemodynamic parameters, emergence     characteristics and adverse events were evaluated.   "
102330|NCT01946698|"     To investigate parameters related to fertility in women with endometriosis in relation to     food items.   "
102331|NCT01946685|"     Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder. Left     untreated or under-treated, it can become a chronic condition associated with significant     distress, depression, aggression, family disruption, and substance abuse. There is also     accumulating evidence that combat-related PTSD is associated with an increased risk of     morbidity and mortality. For the welfare of returning veterans with PTSD and their families,     it is critical that this disorder is promptly identified and effectively treated.     Considerable advances that have been made in the assessment and treatment of PTSD in recent     years; however, psychopharmacological treatments have been shown to be largely ineffective     for veterans with PTSD.      To address this gap, this proposal seeks to test an innovative treatment approach in PTSD -     pharmacological manipulation of the body's major stress system (the     hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is a     glucocorticoid receptor (GR) antagonist with peripheral and central nervous system effects,     making it a compound of interest in the treatment of stress related disorders. There is     abundant evidence of enhanced GR sensitivity in veterans with PTSD which is thought to     underlie some of the symptoms of PTSD and associated disturbances in mood and cognition.     Thus, blockade of the GR receptor with mifepristone may target unique aspects of PTSD and     lead to clinically meaningful improvement in symptoms and cognition. There is preliminary     evidence that short-term mifepristone treatment has sustained beneficial effects on mood,     cognition and sleep disturbance in some neuropsychiatric conditions (major depression,     bipolar disorder, primary insomnia). That there can be sustained clinical and     neuropsychological effects of mifepristone and normalization of basal HPA axis activity after     drug discontinuation in these disorders, has led to the view that mifepristone's actions     include recalibration of a dysregulated HPA axis. Accordingly, we propose to study the     effects of mifepristone in veterans with chronic PTSD to determine if it is efficacious in     improving PTSD symptoms and associated clinical outcomes. To better understand the mechanism     of action of mifepristone we propose to assess the effects of mifepristone on HPA axis     activity and their relationship to treatment outcome and clinical response.      To achieve these objectives, we propose to conduct a Phase IIa, multi-site, double-blind,     placebo controlled trial of mifepristone in veteran outpatients with military-related PTSD     through the VA's Cooperative Clinical Trial Award program. We propose to enroll 136     unmedicated male veterans with military related PTSD at four VA sites (Albuquerque, NM,     Bronx, NY, Durham, NC, and San Diego, CA). Eligible veterans will be randomly assigned in     parallel groups to treatment with 600 mg/day mifepristone or placebo for one week and     followed for up to three months. Using statistical selection theory, we propose to determine     whether 600 mg of mifepristone yields a sufficiently high proportion of clinical responders     after one month to warrant more extensive and definitive research as part of a Phase III     trial. Secondarily, we seek to determine the effect of the dose of mifepristone compared to     placebo on the trajectory of CAPS scores and the time to addition of rescue medication, as     well as compare rates of adverse events and serious adverse events across the three groups.     We will also describe the effects of mifepristone on several other clinical parameters     including PTSD symptomology, depression severity, sleep quality, and functional impairment.     Several measures of neuroendocrine functioning will also be obtained to explore the     relationship of plasma cortisol and ACTH levels to clinical response and the time to addition     of rescue medications.   "
102332|NCT01946672|"     The purpose of this study is to evaluate the feasibility of an isotopic technique to     identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for     gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we     will determine the incidence of lymhedema.   "
102435|NCT01945333|"     The purpose of this study is to develop and pilot test personalized and scalable approaches     to Cognitive Remediation (CR) for schizophrenia and schizoaffective disorder. The intent is     to more clearly define the therapeutic targets important to the facilitation of cognitive and     functional improvement so that clinicians know how to customize cognitive interventions and     deliver treatment in a more effective, efficient and personally relevant manner.   "
102299|NCT01947101|"     Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel     disease, will be invited to take part in this study. The investigators do not know what     causes UC. However, the microbes (such as bacteria and viruses), which normally live in our     intestines are thought to play an important role in the development of UC. There are many     treatment options for UC such as steroids,and other medications that decrease inflammation.     However, none of these can cure the disease.      This study aims to treat pediatric UC in an alternative fashion by changing the microbes in     the gut by giving the participant's stool specimens from healthy adult individuals. There is     some evidence from a few cases of adult UC that this therapy may cure the disease or at least     provide long lasting suppression (remission) of the symptoms. The investigators would like to     test this therapeutic intervention in children with UC.      The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to     determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3)     The investigators will also study the effects of the treatment on colonic gene expression.   "
102300|NCT01947088|"     Participation in music therapy will result in improvement in cognitive functioning, as     measured by neuropsychological testing 9-12 months following surgery.   "
102301|NCT01947075|"     Following the decline of malaria in Sub-Saharan Africa, clinicians face febrile patients in     whom an alternative diagnosis has to be made. This situation has led to an overuse of     antibiotics by clinicians. It is crucial to increase knowledge on etiologies and risk factors     of outpatient febrile illness in order to improve their management.      This present proposal aims to investigate the etiologies of fever among adult patients     attending an outpatient department in urban Tanzania. It also aims to assess the clinical     significance of nasopharyngeal (NP) respiratory viruses and bacteria documentation in this     setting. Third, it aims to compare the spectrum of infections in this population with that of     children included in the same setting in a previous study. The last objective is to assess     diabetes mellitus (DM) as a risk factor for infection and exposure to indoor air pollution     (IAP) as a risk factor for acute respiratory infections (ARI) in adults in Tanzania.      The investigators hypothesize that acute respiratory infections are the main cause of adult     febrile illness in a urban low-income setting and that use of quantitative molecular assays     on naso-oropharyngeal samples can improve the diagnosis of pneumonia. The investigators also     think that the spectrum of infections is different between children and adults, mainly due to     a high HIV prevalence in adults. The investigators also hypothesize that experiencing IAP     and/ or DM is a risk factor for infections in adults.   "
102302|NCT01947062|"     Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the     use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as     cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered     intravenously in the standard three-weekly intervals.      Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial     effects in delaying disease progression among heavily pre-treated patients with various     malignancies.      This study attempts to combine the use of metronomic chemotherapy concurrently during     standard intravenous chemotherapy.   "
102303|NCT01947049|"     The purpose of this study is to:        1. Evaluate the clinical performance of a newly available highly-sensitive rapid influenza          test, Xpert Flu.        2. Derive and validate an adult clinical decision guideline to guide clinical testing of          influenza patients who meed CDC criteria for antiviral treatment.        3. Evaluate impact of rapid influenza testing for antiviral treatment.        4. Determine cost effectiveness of influenza testing and treatment strategies.   "
102304|NCT01947036|"     The study aims to establish whether defects in immune cell function are shared across     multiple autoimmune diseases and whether those problems match to similar genes in the cells.   "
102305|NCT01947023|"     This phase I trial studies the side effects and best dose of lapatinib ditosylate when given     together with dabrafenib in treating patients with thyroid cancer that cannot be removed by     surgery and has not responded to previous treatment. Dabrafenib and lapatinib ditosylate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
102326|NCT01946750|"     Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be     predict the Clostridium difficile infection.      This study evaluates the weight of immunity by studying patients with Clostridium difficile     infection versus controls (each patient is associated with two controls : diarrheal control     without Clostridium difficile, and non-diarrheal control with or without Clostridium     difficile). Recurrence and the kinetics of immune response following infection Clostridium     difficile are studied by following the patients during three months.      There are also building biological samples collections clinically documented: sera, stool and     strains.   "
102306|NCT01947010|"     Inflammatory bowel disease (IBD) are at increased risk of infections. This increased     susceptibility to infections is due to the disease itself, but also be-cause many patients     with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine     and or TNF-a inhibitors.      Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality and     one of the most common cause of bacterial meningitis in adults. Infection with pneumococcus     can be prevented with vaccination. Two pneumococcal vaccine are used in Denmark, the 23     valent polysaccharide-based vaccine (23PPV) and the 13 valent of conjugate pneumococcal     vaccines (PCV13).      In this study the investigators wish to study the effect of pneumococcal vaccination with     either PPV23 or PCV13 in IBD patients treated with either TNF-a inhibitors, azathioprine or     untreated.   "
102307|NCT01946997|"     The purpose of this study is to evaluate topographic features of the posterior pole of the     eye in normal subjects as well as in subjects with diabetes mellitus but without diabetic     retinopathy (DR) using optical coherence tomography (OCT). The investigators proposal is a     novel study to determine retinal volume of normal and diabetic subjects without DR.     Specifically, the investigators will establish a standardized reference range for retinal     thickness and volume that will provide standards for OCT analysis of different clinical     trials for retinal diseases.   "
102308|NCT01946984|"     1. The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP)          is pancreatitis.        2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent          the post ERCP pancreatitis, the investigators used diclofenac vs placebo.        3. The effect of diclofenac in prevention of that complication, was measured by the number          of patients who developed pancreatitis, and compare it with the placebo.        4. The investigators collected 199 patients, 17 excluded, 182 completed the study, all of          them underwent the intervention called ERCP, and randomized to have either Diclofenac          or Placebo before the procedure.   "
102309|NCT01946971|"     This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm     infants with gastroesophageal reflux.   "
102477|NCT01944787|"     The hypothesis of the present study is the hydration of nulliparous women with 250ml/hour vs.     125ml/hrs would decrease the rate of primary cesarean section.   "
102310|NCT01946958|"     The objective of this study is to conduct a randomized control trial to evaluate the impact     of Triple P on the clinic practice of pediatric residents and on select parent and child     outcomes. This study will accomplish that overarching goal through addressing two specific     aims.      Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P     training on practice of pediatric residents in addressing and managing psychosocial problems.      Hypothesis 1: At the completion of the trial, residents assigned to the intervention group,     compared to residents exposed to the control condition, will have:        1. increased skill levels,        2. increased confidence, and        3. increased satisfaction in dealing with and managing psychosocial issues      Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P     interventions on parent's feelings of self efficacy, parent's discipline strategies and on     children's externalizing behavior.      Hypothesis 2: At the completion of the intervention, parents and children receiving the     intervention, compared to those receiving the control condition, will have:        1. greater reduction in targeted child behavior problems,        2. greater reduction in dysfunctional parenting practices,        3. increased use of appropriate discipline and positive parenting strategies, and        4. greater confidence in parenting ability.   "
102311|NCT01946945|"     We propose to perform a clinical randomized trial to evaluate the effect of blastocyst biopsy     and whole chromosome analysis by Next Generation Sequencing (NGS) in comparison to standard     Assisted Reproductive Technologies (ART) methods on on implantation rates, miscarriage rates,     and pregnancy rates.      This will be three studies into one: a) a comparison of treatment (NGS) and no treatment, b)     a non-selection study based on the control group for which we will replace without knowing     the ploidy of the embryos, but we will know it later, c) a retrospective study about the use     of Mitochondrial DNA as a selection tool.   "
102312|NCT01946932|"     This is a steering group approved substudy to the Target Temperature Management trial (TTM,     ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly     controlled temperature regimes for survivors of out-of-hospital cardiac arrest.      The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac     arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control     patients with myocardial infarction.      Our secondary aims are:        -  To investigate the impact of cognitive impairment on our patients' ability to          participate in society and their health related quality of life.        -  To investigate the relationship between our patients cognitive impairments and their          relatives/informants health related quality of life and feelings of burden.        -  To test the hypothesis that the simple cognitive screening battery used in the TTM main          trial is sensitive enough to detect all patients with significant cognitive disability.   "
102313|NCT01946919|"     Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety     of the cinepazide, especially the blood system, has not been fully evaluated in Chinese     population. In order to improve the rational use of cinepazide, the investigators observe its     clinical use in the real world in China, evaluate its safety and clinical benefit in a large     Chinese population.   "
102324|NCT01946776|"     Patients with difficult-to-treat epilepsy (refractory epilepsy) are at high risk of sudden     death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the     possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac     arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable     device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of     time, the frequency of clinically relevant arrhythmias appeared much higher in two small     observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and     underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory     epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients     at high risk of cardiac arrhythmias, so that we can timely institute preventive measures     (e.g. pacemaker implantation).   "
104555|NCT01917604|"     To test the null hypothesis that there are no differences in the outcomes between using an     open or closed surgical method to expose canines that have become displaced in the roof of     the mouth.   "
102314|NCT01946906|"     Patients with Common variable immunodeficiency (CVID) have various forms of autoimmune and     auto inflammatory disorders. The study will investigate if intervention with Rifaximin     modifies the gut microbiota with a subsequent alteration in markers of systemic immune     activation and inflammation in patients with CVID. The investigators hypothesize that the gut     microbiota of CVID patients, at least partly through interaction with the innate immune     system within the intestine, contribute to a low-grade systemic inflammation in these     patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates     systemic inflammation through modulation of the gut microbiota. The study may lead to     increased understanding of the interaction between microbiota and the immune system. The     study could give new insight into important disease processes in relation to the interaction     between the microbiota, the intestine and the systemic compartment, and potentially be the     basis of new therapeutic strategies in these patients to prevent and down-regulate the     auto-inflammatory and autoimmune complications seen in CVID. The findings could also be of     relevance for other disorders where the interaction between microbiota and intestinal and     systemic inflammation is involved such as various cardiovascular and metabolic disorders.      The investigators hypothesize that the gut microbiota of CVID patients, at least partly     through interaction with the innate immune system within the intestine, contribute to a     low-grade systemic inflammation in these patients, and that an intervention with the     non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of     the gut microbiota.   "
102315|NCT01946893|"     The purpose of this pilot study is to collect feasibility and acceptability of an internet     mindfulness meditation intervention for older adults and to collect preliminary data on mood     and cognition changes from before to after the intervention. Up to 32 older adults will be     randomized to receive a mindfulness meditation intervention or a time and attention control,     both delivered over the internet (16 completers). Participants will have a one-hour session     weekly for six weeks with daily home practice between sessions. Participants will complete     the sessions online with a study iPad. Their home practice will also be installed on the     study iPad as well as an objective adherence monitoring program that the investigators     developed to track actual home practice between sessions. The feasibility and acceptability     measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood     questionnaires and cognitive tasks will be measured before and after the intervention period     and data used to conduct power analyses and sample size estimation for a larger clinical     trial.   "
102316|NCT01946880|"     This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on     risk of clinically significant disease reactivation in quiescent SLE patients who have been     on long-term MMF therapy.   "
102373|NCT01946139|"     This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell     changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may     help doctors find cancer cells early and plan better treatment for anal cancer. Completing     multiple screening tests may help find the best method for detecting cell changes in the     anus.   "
102374|NCT01946126|"     This study is a retrospective chart review in patients diagnosed with headache or migraine to     evaluate treatment patterns and diagnosis.   "
102317|NCT01946867|"     RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the     western world. The oropharynx is the posterior continuation of the oral cavity and connects     with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of     primary head and neck cancers. These structures play a crucial role in swallowing, breath and     speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate     muscles or nerves, which significantly disturb local functions. The incidence of Head and     Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population     as recorded by the Surveillance, Epidemiology, and End Results registries in the United     States. Regarding the therapeutic strategies, the association of radiotherapy with     chemotherapy or biologics has demonstrated significant improvement of outcomes with the     drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival     improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell     killing and complete tumor shrinkage allowing a definitive treatment and preservation of     local structures and functions in patients older 65 years, who cannot receive cisplatin.   "
102318|NCT01946854|"     Appendiceal cancer is a rare disease that does not cause many symptoms. As such, doctors are     not sure if chemotherapy actually has an effect on the disease. The goal of this clinical     research study is to learn more about the effects that chemotherapy may have on appendiceal     cancer.   "
102319|NCT01946841|"     The objective of this unblinded study is to assess the nutritional effects of a 12 weeks     administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the     impact on the patients' quality of life.   "
102320|NCT01946828|"     The objective of this clinical trial is to evaluate the FIM optimal configuration and confirm     the safety and performance/efficacy of the FIM when exposed to a larger and more varied     population of users.   "
102321|NCT01946815|"     Natural course of intermediate coronary artery disease (CAD) is very important to predict the     prognosis of the patient with such disease.      Several studies have well demonstrated the beneficial effect of lipid-lowering therapy on the     progression of CAD with the modification of lipid profiles.      This effect can be also explained by intravascular ultrasound (IVUS) or optical coherence     tomography. However, the effect of plaque modification on coronary physiology has been rarely     evaluated.      This research is to evaluate the change of intermediate or nonculprit coronary lesion on     lipid-lowering therapy via IVUS(optional) and FFR.   "
102322|NCT01946802|"     Current guidelines recommend the use of sedatives and neuromuscular blocking agents to avoid     shivering during therapeutic hypothermia in cardiac arrest victims. Therefore, it is     difficult to detect seizure and the frequent or continuous EEG monitoring is recommended.     However, it is difficult to follow this recommendation in most clinical situations due to the     lack of specialized devices and persons. The purpose of this study is whether SEDline     (frontal 4-channel EEG device) has a diagnostic value to detect seizure during therapeutic     hypothermia in cardiac arrest victims.   "
102323|NCT01946789|"     The proposed clinical trial is a phase I, open-label, multi-center, dose-escalation study of     ALT-803 in patients with surgically incurable advanced solid tumors: melanoma, renal cell,     non-small cell lung and squamous cell head and neck cancer   "
102327|NCT01946737|"     CT technology is evolving at a rapid pace, with introduction of multidetector row CT scanners     (MDCT) and electrocardiographic (ECG) gating resulting in increasing numbers of heart scans     CTCA (CT Coronary Angiography). CTCA provides a noninvasive alternative to conventional     invasive coronary angiography (ICA), which is considered the gold standard in the     investigation of coronary disease. There has been a gradual increase in the utilization of     CTCA for primary assessment of low and intermediate risk patients. However concerns regarding     radiation exposure and diagnostic accuracy, especially in the highrisk group, have prevented     its widespread dissemination.      To achieve best possible temporal resolution (minimize cardiac motion artifacts) and spatial     resolution (provide diagnostic accuracy) relatively high radiation exposure is required, as a     result of its inverse relationship with image noise and resolution. However radiation (X-ray)     is associated with increased risk of cancer in exposed patients and it is therefore essential     to continually devise strategies to reduce radiation exposure whilst maintaining image     quality.      A state-of-art CT scanner (Discovery CT750 HD, General Electric (GE) Healthcare), has been     installed at Derriford hospital for further research on CTCA. It uses novel method of     scanning, High Definition Computed Tomographic Coronary Angiography(HD-CTCA), analogous to     high definition television) and image reconstruction (Adaptive Statistical Iterative     Reconstruction ASIR)as opposed to conventional CT scanners using Filtered Back Projection     (FBP)reconstruction. HD-CTCA enables acquisition of sharper images and ASIR offsets the     resultant increase in radiation exposure. This is likely to result in images of higher     diagnostic quality with an equivalent or slightly lower radiation exposure compared to     present technology. Although initial results are encouraging, this needs further assessment     before being applied to routine clinical practice. To assess this we have designed a study to     perform HD-CTCA on 300 consecutive patients undergoing diagnostic ICA at Derriford hospital,     directly comparing the accuracy of HD-CTCA to ICA (presently considered the gold standard).      Hypotheses:      There is no significant difference in the sensitivity and specificity of HD-CTCA for the     detection of coronary artery stenosis of 50% or greater compared to conventional ICA.   "
102333|NCT01946659|"     This is a randomized controlled Trial to evaluate effect of a culturally and linguistically     tailored, telephone-delivered behavioral intervention on adherence to recommended assessment     and treatment of sleep apnea in Blacks with Metabolic Syndrome. The investigators believe low     awareness of Sleep Apnea and the risk it imposes to an individual health plays an important     role in underdiagnosis and low adherence to treatment among Blacks. Hence, culturally and     linguistically tailored health education will decrease the knowledge gap and improve     adherence to recommended assessment and treatment of sleep Apnea. the investigators believe     the effect of adherence to treatment of Sleep apnea is shown to improve the components of     Metabolic syndrome and hence promote well control of Hypertension, Diabetes, weight,     triglyceride and cholesterol.   "
102334|NCT01946646|"     The purpose of this study is to determine whether combination of TS-1 and concurrent and     short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this     study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential     of local control of concurrent chemoradiotherapy in pancreatic cancer.   "
102335|NCT01946633|"     The present study is a feasibility study to assess the safety and efficacy of wireless     capsule endoscope and compare the data obtained with those obtained by using a conventional     esophagogastroduodenoscopy.      The product was developed and manufacture in China.(the NaviCam. AKC-1.China)   "
102337|NCT01946607|"     Neuroticism is a personality trait described as an enduring tendency to experience negative     emotional states and to respond poorly to environmental stress. It has been shown that high     neuroticism can predispose, amongst other factors, to the development of depressive episodes.     Recent studies suggest that subjects with high neuroticism have a different response to     stimuli with an emotional content, showing both decreased processing of positive or increased     processing of negative emotionally salient cues. These differences in cognitive processing of     emotional stimuli are believed to underpin the psychological characteristics that link high     neuroticism with a higher risk for depression.      Preliminary data also indicate that modulation of serotonin function by antidepressant     treatment in healthy volunteers with high neuroticism traits could modify the brain activity     associated with the processing of emotional stimuli that is dysfunctional in this vulnerable     population.      The aim of this research is to investigate further whether modulation of serotonin function     via administration of serotonergic antidepressants (SSRIs) can revert the dysfunctional     emotion processing that characterises subjects with the personality trait of high     neuroticism.      In particular we hypothesise that SSRI administration will modify the abnormal patterns in     attention, physiological reactivity and regulation of emotional stimuli present in healthy     individuals with the vulnerable personality trait of high neuroticism.      Carrying out this research on healthy volunteers will enable us to understand if modulating     serotonin function by antidepressant administration has an effect not only on mood symptoms -     as is evident in depressed patients - but also on the predisposing psychological and     cognitive processes that sustain the depressed mood, such as the response to emotional     stimuli. We will also be able to verify if this effect is shown early treatment and prior to     any subjective changes in mood. This will be done by administering seven days of either the     antidepressant citalopram or placebo to subjects with high neuroticism scores and then     comparing them on a series of computer based psychological tests measuring various aspects of     how emotionally salient stimuli are processed.   "
102338|NCT01946594|"     The study team aims to conduct a double-blind, placebo-controlled, pilot study to assess the     effect of prophylactic antipyretics on the immune responses and rates of fever after     inactivated influenza vaccine (IIV) in children 12 through 35 months of age. In this pilot,     40 healthy children, 12 through 35 months of age, including some children at risk of febrile     seizure, will be randomized to receive prophylactic acetaminophen or oral placebo immediately     following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV. Data derived     from the pilot study will be used to assess the feasibility of conducting a larger scale     study. Feasibility will include assessments of the speed and ease of study recruitment and     adherence to and completion of study assessments. Children will be followed for the     occurrence of fever, fussiness, changes in appetite and sleep patterns, and use of medical     services on the day of and day following vaccination. Antibody to influenza antigens     contained in the 2013-2014 vaccine as measured by hemagglutination inhibition (HAI) antibody     will be assessed at baseline and four weeks following vaccination. The proportions of     children experiencing fever, having solicited reactions, using medical services,     demonstrating a serologic response corresponding to seroprotection and seroconversion to each     of the IIV antigens will be determined for groups of children receiving acetaminophen and     placebo. Likewise geometric mean HAI titers (GMT) and corresponding 95% confidence intervals     for each IIV antigen will be calculated for both vaccine groups.   "
102339|NCT01946581|"     Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction     among patients who have recently undergone cataract surgery.   "
102340|NCT01946568|"     A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients     aged 3 months to 11 years (inclusive) following the intravenous administration of a single     dose of dalbavancin.   "
102367|NCT01946217|"     This pilot research trial studies factors affecting patient participation in Acquired Immune     Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining     how patients makes decisions about participating in a clinical trial may help doctors plan     clinical trials in which more patients are willing to participate and are satisfied with     their decision to participate.   "
102368|NCT01946204|"     The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men     with high-risk non-metastatic castration-resistant prostate cancer.   "
112254|NCT01816620|"     The purpose of this prospective study is to determine the efficacy and safety of lenalidomide     plus dexamethasone in patients with newly diagnosed POEMS syndrome.   "
102341|NCT01946555|"     The BTP (Breakthrough pain)was defined as a transient exacerbation of pain that occurs     either spontaneously, or in relation to a specific predictable or unpredictable trigger,     despite relatively stable and adequately controlled background pain.      The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough cancer     pain). The prevalence of BTcP is equal to 56%.      Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP in     the three sub-types: voluntary, non- voluntary and procedural.      The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe     changes in the intensity of pain during the day, so it is necessary to differentiate slight     fluctuations from the presence of real episodes of BTCP, for which is necessary to use a     rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm,     present in the literature, to perform the diagnosis of BTCP.      In the presence of BTCP, is important both a correct controlled background pain with major     opioids, which can reduce the number and the intensity of the painful episodes, both     implement an adjunctive therapy, called rescue, to be administered at the time which takes     over the painful episode using, in this case, an opioid greater.   "
102342|NCT01946542|"     The purpose of this project will be to determine whether consumption of beet juice     concentrate prior to exercise may acutely improve exercise tolerance in patients with heart     failure.   "
102375|NCT01946113|"     Acute renal failure is a common complication in intensive care unit patients. In 10% of cases     renal replacement therapy becomes necessary. Current devices have increase filter patency and     efficacy. However, magnesium, calcium and phosphate are eliminated as well. However, the     extend of this elimination hase not been quantified. Thus, we want to        1. record retrospectively how often abnormal values for phosphate, magnesium and calcium          occurred during routine renal replacement therapy in 2011 and 2012.        2. prospectively evaluate the same parameters during routine treatment in 2013 and 2014   "
102343|NCT01946529|"     This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and desmoplastic     small round cell tumor (DSRCT). Participants with ESFT will be divided into two treatment     groups, A or B, based on tumor characteristics.      Group A (standard risk) participants have tumor that is not in the pelvis, has not spread to     other parts of the body, and are less than 14 years of age. Because previous clinical trials     have shown that standard treatment is very effective for children whose tumors have these     characteristics, these participants will receive standard treatment.      Group B (high risk) participants are 14 years of age or older or have tumor in the pelvis, or     the tumor has spread to other parts of the body. Participants with DSRCT in the abdomen     and/or pelvis or with tumor that cannot be removed by surgery alone or has spread to other     parts of the body will be included in Group B. Participants in this group are considered high     risk because there is a greater chance of tumor recurring following standard treatments     currently in use.      All participants will be followed and evaluated for 10 years following completion of therapy.   "
102344|NCT01946516|"     The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C     infection among newly diagnosed cancer patients presenting to community and academic oncology     clinics.   "
102345|NCT01946503|"     The purpose of this study is to better understand why children with short gut develop feeding     problems.   "
102346|NCT01946490|"     A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery     of very high radiation doses is needed to obtain local control, but due to the large tumor     and nodal volume this is often impossible without causing unrepairable damage to the normal     tissue of the mediastinum, spinal cord, esophagus and lung.      Although every tumor is different with respect to the speed with which it grows and spreads,     it is obvious that time plays an important role in cancer therapy. Recently it was reported     that disease progression or increase of tumor volume occurred during the time interval     between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment     and consequently have an impact on overall survival. Moreover, the increasing number of     diagnostic procedures, aimed at obtaining more accurate information about the tumor extension     and biology, as well as the use of more sophisticated but labor intense radiation techniques     could prolong the time interval between clinical symptoms and the start of the treatment.     However, the influence of new diagnostic procedures or the applied radiotherapy techniques on     waiting times is not yet known. The investigators therefore want to investigate 1) time     trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and     the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between     waiting times and overall survival.      The hypotheses of the study:        1. The diagnostic delay for NSCLC patients has increased during the last 12 years.        2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12          years.        3. Prolonged waiting times are associated with worse overall survival outcome.   "
102348|NCT01946464|"     This study is being done to see if we can improve the way we manage patients' airways. In     some instances patients who have a beard, who do not have teeth or have breathing problems     during sleep present a challenge to the anesthesiologist. In such patients, it is sometimes     difficult to provide air/oxygen for breathing using a mask. The study doctors would like to     investigate a new method for holding a mask on the face of those patients. They are     interested in comparing a new method against two older methods. They believe the new method     will deliver a larger amount of air to the lungs. This information may help doctors provide     better care for patients who have beards, no teeth, or breathing problems during sleep.   "
102349|NCT01946451|"     The purpose of this study was to investigate the expression of selected genes both in     epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with     primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible     correlations between messenger ribonucleic acid (mRNA) levels of these genes were also     identified.   "
102369|NCT01946191|"     The purpose of this study is to test whether online tracking tools and weight maintenance     coaching visits for patients and real-time electronic progress reports for primary care     providers (PCPs) [Continued Coaching (CC)] will support more successful weight maintenance     than online tracking tools alone [Tracking Only (TO)] in a group of primary care patients who     have lost ≥ 5% of their body weight.   "
104656|NCT01916278|"     A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and     efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine.   "
102350|NCT01946438|"     The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and     Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety     and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65     years of age.      Primary Objective:        -  To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone          Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2013-2014          formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years          of age.      Observational objectives:        -  To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and          Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of          the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in          adults ≥ 65 years of age.        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone          Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group          with the historical requirements of the Committee for Human Medicinal Products (CHMP)          Note for Guidance (NfG) CPMP/BWP/214/96.        -  To submit sera from selected subjects to the Center for Biologics Evaluation and          Research (CBER) for further analysis by the World Health Organization (WHO), the Centers          for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to          support formulation recommendations for subsequent influenza vaccines.   "
102376|NCT01946100|"     To gather preliminary safety and outcome data for the multimodality treatment of lung     adenocarcinoma in the setting of multifocal BAC.   "
102351|NCT01946425|"     The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent     vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata     (6 months to < 36 months and 3 years to < 9 years)      Primary Objective:        -  To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine,          administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on          Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.      Observational Objectives:        -  To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP          recommendations, in children 6 months to < 9 years of age.        -  To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER)          for further analysis by the World Health Organization (WHO), the Centers for Disease          Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support          formulation recommendations for subsequent influenza vaccines.   "
102352|NCT01946412|"     The purpose of this study is to provide information regarding the long-term safety and     pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of     age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will     further explore the efficacy of long-term ivacaftor treatment in this population of patients     with CF.   "
102353|NCT01946399|"     To determine if Ozurdex implant can offer an effective treatment for macular edema associated     with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have     not demonstrated a significant response.   "
102354|NCT01946386|"     The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with     Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar®     ointment and LEO 90100 vehicle using a human skin blanching test.   "
102355|NCT01946373|"     The purpose of this study is to learn if dendritic cell vaccine will increase the effect of     tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with     melanoma.   "
102356|NCT01946360|"     Blood will be collected after venepuncture from all patients for complete blood counts, Serum     bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase,     alkaline phosphatase, gamma glutamyl transferase, prothrombin time and INR, urea, creatinine,     sodium, potassium, serum total protein and albumin, within 24 hours after admission and twice     a week there after or as and when needed.      Time line for blood tests and evaluation of clinical parameters & 13C-MBT      For ALF patients:      On days 0, 1, 3, and 7      For ACLF patients:      On days 0, 7 (week 1), 14(week 2), 28 (weeks 4)      Blood tests would include:      Serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase,     alkaline phosphatase, gamma-glutamyltransferase, Serum proteins (total and albumin),     prothrombin time & international normalized ratio (INR), Serum urea and creatinine, serum     electrolytes, arterial ammonia and arterial blood gas analysis.   "
102357|NCT01946347|"     The aim of the study is to evaluate the effect of hyperinsulinemia and postprandial changes     in plasma glucose and lipids concentrations on the endothelial function together with other     metabolic parameters in patients with type 2 diabetes (T2D) and in healthy subjects.      Hypothesis:      Different changes in endothelial function to acute in vivo induced hyperinsulinemia and after     the meal test will be found in patients with T2D compared to healthy subjects.      A significant relationships between insulin sensitivity, selected adipokines intramyocellular     fat content, hepatic fat content and high energy phosphates in soleus muscle will be     documented in both groups.   "
102358|NCT01946334|"     The anorectal manometry is the gold standard in the evaluation of anorectal function.      Several techniques are currently used (balloons, perfused catheters) and are always performed     in the supine position.      Few studies have reported the evaluation of sphincter function in the upright position,     whereas symptoms of fecal incontinence occur in this position.      Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows     topographic analysis and evaluation of anorectal function more acurate. In addition, the     rigid nature of the probe should allow stability measures / recording, which is not possible     with probes perfused catheters example.      We therefore propose to compare anal sphincter pressure in supine and standing, measured in     high-resolution manometry.   "
102370|NCT01946178|"     The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic     focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer     non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess     the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal     treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy     following treatment with the device or who are seeking relief from fibroid-related symptoms.   "
102359|NCT01946321|"     During any period of rehabilitation it is important to select meaningful tests that; measure     what you want, are responsive to changes in the patient's condition and, easy to use in the     clinical settings. With an amputee such tests may help make sure that rehabilitation     programmes and the prosthesis (artificial leg) provided are tailored for the individual. New     prosthetic technology is continually being developed and the active amputee now demands more     from their artificial limbs. Making sure that they get the right rehabilitation programmes     and the most appropriate prosthesis will help them perform to their best.      Thirty amputees who have recently undergone a lower limb amputation will be recruited into     this study. They will be asked to complete 2 walking tests and 4 questionnaires that measure     different aspects of their recovery from the comfort of the socket to their perceived ability     to undertake everyday tasks. Each of the tests give a score or grade which represents the     level of their ability, as judged by the test, at that given time point. The tests will be     repeated at one and three weeks after delivery of their prosthesis, just before discharge     from hospital and at 6 weeks post-discharge.      By measuring the changes in the scores across these time points, and also how the amputees     feel they have changed, it is hoped that it can be determined how responsive the tests are to     objective measures of changes in the amputees abilities and also whether the tests are     sensitive to the changes felt by the amputee. If it is shown we can more accurately link     changes in the scores to the changes in the amputees abilities then Physiotherapy treatment     programmes could be more accurately tailored to the individual amputee.   "
102377|NCT01946087|"     The aim of this study is to investigate whether RIPC protects the heart against ischemia     reperfusion injury on the concentrically hypertrophied myocardium   "
102378|NCT01946074|"     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and     preliminary efficacy of ABT-165 in subjects with advanced solid tumors. The early clinical     development plan for ABT-165 is based on the activity demonstrated in preclinical models.   "
120332|NCT01710852|"     The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF     (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF   "
102360|NCT01946308|"     Babies born too soon, premature babies, can have complications following birth because their     systems are immature. Hospitals help prevent deformities and delays in motor development by     using therapeutic positioning to provide containment as they would experience in the womb.     They also often have trouble eating. They have discomfort, are irritable, refuse to eat and     cry because their digestive system is immature. The neonatal intensive unit can create stress     and disrupt their sleep. Going from active to deep sleep is essential for infant brain     development, learning and memory formation. Their sleep states early in life predict their     developmental outcome. The purpose is to determine whether a conformational positioning     system, one that can mold to the baby and contain him or her, will allow more time asleep in     premature infants with feeding problems compared to the standard crib mattress. We     hypothesize that the number of total sleep time will be longer and the number of arousals out     of sleep lower when they are sleeping on the conformational positioning system compared to     the mattress.   "
102361|NCT01946295|"     Objective of the trial is to study if famotidine add-on treatment is more effective than     placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient     response to ongoing antipsychotic treatment.   "
102362|NCT01946282|"     Through this program, the investigators will test a systematic colon cancer screening     outreach strategy for increasing screening completion among uninsured patients, not     up-to-date with screening. The intervention will consist of mailed screening invitations,     with processes such as phone reminders to promote screening and evidence based follow up. All     patients will be randomly assigned to receive mailed invitations to complete a home fecal     immunochemical test (FIT). Some patients will be randomly assigned to receive a small     financial incentive on completion of FIT testing.   "
102363|NCT01946269|"     The purpose of this study is to determine whether a goal-directed resuscitation therapy     within the first 8 hours after major abdominal cancer surgery reduces postoperative     complications compared to a standard therapy.   "
102364|NCT01946256|"     PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH     ENDOCERVICAL SWAB.THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE     COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT.THE PARTICIPANTS WILL     BE RANDOMISED INTO ONE OF THE TWO GROUPS.THE DRUGS WILL BE TAKEN FOR I WEEK AND THE SEXUAL     PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION WILL ALSO     BE USED DURING THE TREATMENT.THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH TELEPHONE CALLS     AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM. LATEX MALE CONDOM     WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT ACROSS TO THEM DURING     THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB WILL BE TAKEN 4 WEEKS     AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY PROFORMA WILL BE FILLED     DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL PACKAGE FOR SOCIAL SCIENCES     VERSION 17.   "
102365|NCT01946243|"     The overall objective of the study is to assess the feasibility of implementing a     quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use     of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.   "
102366|NCT01946230|"     The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the     reasons result in these situations is the patent visits hospital for treatment in late stage     of oral cancer. Recently, the government makes effort in oral cancer screening to find oral     potentially malignant disorders (OPMD) early. However, there is no conscience in treatment     strategies of OPMD up to now. In this study, we will set a OPMD data bank, and use the cases     to find out the potential biomarker, which is able to predict the oral cancer malignant     transformation. Sixty OPMD with oral cancer transformation will be recruited, and 60 OPMD     with no oral cancer malignant transformation will also be enrolled as the disease control     group. Besides, 20 normal cases and 60 oral cancer cases resulting from previous OPMD will be     collected. All those groups will detect the expression of p62/SQSTM1 to investigate the     possibility that p62/SQSTM1 as a biomarker to predict the malignant transformation of OPMM,     and a guideline to treat or not to treat OPMD.   "
102400|NCT01945788|"     The primary objective of this study is to compare efficacy and safety of two formulations of     teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with osteoporosis.   "
102371|NCT01946165|"     The goal of this clinical research study is to learn if adding the combination of abiraterone     acetate and prednisone with or without enzalutamide to hormonal therapy can help to control     prostate cancer when given before surgery. The safety of the drug combination will also be     studied.   "
102372|NCT01946152|"     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     pomalidomide that can be given in combination with dexamethasone and neupogen (filgrastim) to     patients with relapsed or refractory MM.      The goal of Part 2 of this study is to learn if the drug combination can help to control MM.      The safety of this drug combination will be studied in both parts.   "
102478|NCT01944774|"     The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of     Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with     community-acquired pneumonia (CAP).   "
102379|NCT01946061|"     Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients     could underwent curative surgery. In those, about 60% of patients would survive after 5 years     from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1     adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric     cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient     in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In     addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy     could increase disease-free survival after D2 gastrectomy in advanced gastric cancer     patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer     has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant     chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric     cancer patients.   "
102380|NCT01946048|"     The aim of the present study is to investigate safety and efficacy of intramyocardial     implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .   "
102381|NCT01946035|"     Allergic rhinitis (allergic inflammation of the nose) is a common medical condition which is     known to seriously decrease quality of life, aggravate preexisting conditions particularly     asthma, carry significant medical treatment costs and be responsible for reduced work     productivity and lost school days. A significant symptom of the condition, nasal blockage,     remains difficult to treat even when using nasal corticosteroids. Decongestant medications     act on the blood vessels in the nose and have an immediate effect in clearing a blocked nose     but if used for more than seven days a more severe rebound congestion of the nose develops.      In this study, the investigators aim to assess the effects of doxazosin, a drug which is     currently used to treat high blood pressure and symptoms of prostate enlargement, to find out     if it has an effect on nasal blockage.   "
102382|NCT01946022|"     This study is intended to evaluate ovarian cells after being submitted do different in vitro     fertilization protocols. The investigators will analyze hormones secretion and intracellular     mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist     protocol.   "
102383|NCT01946009|"     Cidofovir could be an effective drug for the treatment of Anal Intraepithelial     Neoplasia(AIN).   "
102384|NCT01945996|"     In this study, an existing mobile health intervention to improve diabetes self-management     will be combined with a social support module and tested for feasibility. The investigators     hypothesize that this combination will be feasible and acceptable to both patients and their     loved ones.   "
102385|NCT01945983|"     Current septic shock guideline recommends fluid resuscitation as the first treatment.     Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid     therapy. This can cause a certain duration of systemic hypotension before vasopressor is     commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of     septic shock may increase blood pressure quicker than start treatment with intravenous fluid     alone. The rapid restoration of perfusion pressure may improve septic shock outcome.   "
102386|NCT01945970|"     Epidemiological studies indicate that regular consumption of three cups of black tea per day     reduces the risk of stroke or myocardial infarction. In a number of previous nutrition     intervention studies tea has been shown to improve vascular function as assessed by Flow     Mediated Dilation (FMD).   "
102387|NCT01945957|"     This is a 4 part study:      Phase 1a. -functional magnetic resonance imaging (fMRI) ( with oxytocin 24 IU vs. placebo =     oxytocin 0 IU) - funded by grant #U54 HD079124-01, Phase 1b-eye-tracking(oxytocin 24 IU vs.     placebo = oxytocin 0 IU), Phase 2a. fMRI (oxytocin 8 IU vs. oxytocin 40IU), Phase 2b.     -eye-tracking (oxytocin 8IU vs. oxytocin 40IU). Time course of effect will also be assessed     within session.   "
102388|NCT01945944|"     Children who need to be on a ventilator often have thick secretions/mucus in their lungs.     These secretions can obstruct the breathing tube and their windpipe, which can worsen lung     function and prolong the need for the ventilator. Hypertonic saline is a medicine that is     used to thin out secretions in patients with cystic fibrosis (and other conditions). We     hypothesize that having children on a ventilator inhale this medication will shorten the     amount of time that they need to be on the ventilator.   "
102389|NCT01945931|"     The purpose of this trial is to determine if the safe delivery smartphone application     distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence     of postpartum haemorrhage. It is also the purpose to determine if the safe delivery     smartphone application distributed to health workers in Ethiopia will increase health workers     knowledge and skills in intra-partum management of active management of third stage labour 2)     treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal     resuscitation.   "
102390|NCT01945918|"     This project will test different ways of helping primary care practices to do a better job of     self-management support (SMS) for their patients with diabetes.   "
102401|NCT01945775|"     The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and     efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice     in patients who have locally advanced and/or metastatic breast cancer with germline BRCA     mutations.   "
102402|NCT01945762|"     This is a European multinational, multicenter, non-interventional (observational) and     prospective study. It is carried on to confirm in real life conditions the benefit/risk of     vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with     symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.   "
102391|NCT01945905|"     -  Tuberculosis ( TB ) remains a major global public health problems and actions to ensure          the diagnosis and complete treatment of all cases is the priority for the control of          this disease. Despite the availability of effective anti-tuberculosis medications, there          are still high levels of nonadherence to treatment. The nonadherence increases the          morbidity and mortality of patients, decreases the cure rate, increases the community          transmission and the increase of chronically ill patients enables the emergence of multi          - drug resistant and increases treatment costs.        -  Despite the knowledge about different forms of cost-effective delivery of DOT (directly          observed treatment), recognition of the need to establish the DOT strategy related to          the context from local studies, in Colombia and in Cali we hadn't had made studies          similar than this one that establish the cost and results of the current DOT delivery          strategy and to identify other ways to improve adherence and cure rate for the TB          patients at reasonable cost for both: health services and families        -  Therefore, this research aims to compare the cost -effectiveness of current DOT delivery          method with an alternative extra- institutional delivery of anti -TB treatment in urban          areas of Cali. A cost-effectiveness study was conducted from the institutional and          familiar perspective with prospective information collection.   "
102392|NCT01945892|"     To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.   "
102393|NCT01945879|"     Venous thromboembolic events are considered to be a prognostic negative factor and small     studies showed astonishing survival advantages using heparin as prophylactic treatment to     prevent venous thromboembolic events. Based on these assumptions our Charité - Onkologie     (CONKO) study group planned to conduct a randomized trial to investigate the impact of low     molecular weight heparin (LMWH) in a prospective setting in patients with advanced pancreatic     cancer undergoing first line therapy, the CONKO-004 trial. During the preliminary stages we     had to undertake a pilot trial to get information on safety and feasibility of combined     chemotherapy with simultaneous treatment of the LMWH Enoxaparin in patients with advanced     pancreatic cancer who are at high risk of gastrointestinal bleeding due to local cancer     spread.   "
102394|NCT01945866|"     Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as     treatment for center-involved diabetic macular edema (DME), a substantial proportion of     anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of     retinal thickening. Indeed, over 50% of ranibizumab-treated eyes did not achieve a 2 or more     line improvement in visual acuity from baseline at 2 years in Protocol I, a previous DRCR.net     (Diabetic Retinopathy Clinical Research Network) study. Furthermore, 27% of     ranibizumab-treated eyes still had central subfield (CSF) thickness on time-domain optical     coherence tomography (OCT) ≥ 300 at 1 year, and more than 40% of ranibizumab-treated eyes did     not achieve complete resolution of retinal thickening (< 250 microns) by 2 years. Thus, there     is a need for alternative or additional treatments that will improve vision by reducing     retinal edema in eyes with persistent DME following previous anti-VEGF therapy. Intravitreal     steroid is not as efficacious as ranibizumab in eyes with DME overall, but it has been shown     to have a positive effect for DME in some eyes and might add benefit in eyes that are already     receiving anti-VEGF.      The main objective of this study is to assess the short-term effects of combination     steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with     that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and     visual acuity impairment despite previous anti-VEGF treatment. This study will provide     important information for the design of a future confirmatory phase III clinical trial on the     efficacy of combination steroid and anti-VEGF in eyes with persistent DME and vision     impairment following previous anti-VEGF therapy. The primary outcome for efficacy will be the     mean change in visual acuity at 24 weeks.      Each study eye is required to complete a 12-week run-in phase. The run-in phase will identify     study eyes that truly have persistent DME despite anti-VEGF therapy by requiring an     additional 3 injections while also collecting standardized visual acuity and OCT     measurements. At the enrollment, 4-week and 8-week visits of the run-in phase, enrolled eyes     will receive an intravitreal injection of ranibizumab 3mg. Then at the 12-week run-in visit,     if the eye still has persistent DME, it will be randomized to receive either intravitreal     sham+intravitreal ranibizumab 0.3 or intravitreal dexamethasone+intravitreal ranibizumab 0.3     injections. The randomized study duration is 24 week, during which a protocol visit takes     place every month. The combination injections of sham+ranibizumab or dexamethasone     +ranibizumab will be given at the randomization visit (baseline) and at the 12-week visit     after randomization. In between, an intravitreal injection of ranibizumab only will be given     to study eyes at the 4, 8, 16 and 20 week visits.   "
102395|NCT01945853|"     This is a pilot study to identify the degree of grey and white matter involvement in patients     with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be     utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These     results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to     assess if any changes in MRI can be predictive in the disability of the ALS patients at     baseline and at 6 month intervals. The participants will be asked to return every 6 months     for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and     MRI as outlined above to monitor progression of the disease.   "
102396|NCT01945840|"     The purpose of this study is to assess whether the changes in gut hormones seen following     Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen     post-operatively.   "
102397|NCT01945827|"     The primary objective of this registry is to assess the safety and angiographic outcomes of     endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.   "
102398|NCT01945814|"     In this study, investigators are trying to see if infusion of T cells (called CTLs) will     prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV)     reactivation or infection.      Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem     cell transplant. After receiving transplant, they are at risk of infections until a new     immune system to fight infections grows from the cord blood cells. In this study,     investigators are trying to give special cells called T cells. These cells will try to fight     viruses that can cause infection.      Investigators will test to see if blood cells from donor that have been grown in a special     way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can     cause serious life-threatening infections in patients who have weak immune systems after     transplant.      T lymphocytes can kill viral cells but normally there are not enough of them to kill all the     virus infected cells after transplant. Some researcher have taken T cells from a person's     blood, grown more of them in the laboratory and then given them back to the person during a     viral infection after a bone marrow transplant. Some of these studies have shown a positive     therapeutic effect in patients receiving the CTLs after a viral infection in the     post-transplant period.      Investigators will grow these cells from donor in the laboratory in a way that will train     them to recognize and remove viruses when the T cells are given after a transplant. Since     most donors have previously been infected with EBV, CMV, and adenovirus, investigators are     able to use their T cells that remember these viruses to grow the CTLs. However, they now     also have a new way of growing CTLs from donors who have not been infected with CMV.   "
102399|NCT01945801|"     This study evaluates the intervention of the 1) sodium-restricted diet, or 2) diuretic, or 3)     placebo pill in the treatment of obstructive sleep apnea in adults.   "
102421|NCT01945515|"     1. Study objective To evaluate the effect of robotic-assisted gait training combined with          transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted          gait training on gait function of chronic stroke patients        2. Subjects chronic stroke patients with gait impairment        3. Methods             -  Group 1: Robotic-assisted gait training with anodal tDCS (45 min)             -  Group 2: Robotic-assisted gait training with sham tDCS (45 min)             -  Duration of treatment: 2 weeks, 5 times a week             -  Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment   "
102403|NCT01945749|"     Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and     disability. As no cure exists, management aims to reduce pain, improve function, and enhance     quality of life. The recommended hierarchy of management should consist of exercise in first     line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.      The effect size of exercise therapy is of the same magnitude as most pharmacological     treatments but is often without adverse effects. Local pharmacological treatment of the     afflicted knee joint is recommended by means of intra-articular injections of     corticosteroids, which is considered as a standard medical treatment of knee OA and are     included in established guidelines for management of knee OA. While the two treatment     approaches have been investigated separately in numerous clinical trials, the efficacy of a     combined pharmacological and non-pharmacological approach is not known, despite the high rank     of such combined treatment approach on the recommended hierarchy of management.      The purpose of this study is to assess the effects of exercise therapy in combination with     intra-articular corticosteroid injections on patient reported pain and function in patients     with knee OA.      The hypothesis is that the combined treatment approach (exercise therapy preceded by     intra-articular injection of corticosteroid) enhances the clinical outcome compared to     exercise therapy preceded by a placebo injection.   "
102404|NCT01945736|"     The purpose of this study is to learn more about how the study drug, methadone, prescribed by     an infant's or child's physician as part of standard medical care, is processed in children     and young adults. While this drug is used extensively in infants and children, it has not     been extensively studied in this population.      Physicians do not have very much information on how long it takes for methadone to be removed     from the blood circulation and passed out of the body. Physicians need more information to     guide how much and how often we should give methadone to children/young adults to ensure they     get the maximum effect with the minimum amount of drug. During this research study, the study     team will collect information about how this drug is processed in infants and children.   "
102405|NCT01945723|"     Tissue characterization will be performed, from different regions of the gastrointestinal     tract in healthy volunteers.   "
102406|NCT01945710|"     Study E7389-E044-112 is a Phase 1 study designed to assess the safety, tolerability and     preliminary efficacy of E7389 liposomal formulation (E7389-LF) in patients with solid tumors.     This dose-escalation study will determine the maximum tolerated dose, dosing schedules     tested, the dose schedule regimen with a more favorable tolerability profile, and a     preliminary indication of efficacy.   "
102407|NCT01945697|"     The aim of this study is to evaluate the association between several methylated genes and     oral cancers. A prospective case control trial is designed with sample size estimated at     least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or     oral cancer, and ~60 subjects with normal oral mucosa. This study is approved by the National     Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all     of the subjects will receive an intraoral examination and the oral epithelial cells will be     collected. If abnormal oral lesion is observed, it will be photographed, and the biopsy will     be performed to confirm the diagnosis. For methylated gene detections, the gDNA will be     extracted from the collected cells and standardized assay will be performed. Clinical     sensitivity and specificity for these methylated genes will be evaluated.   "
102408|NCT01945684|"     Purpose: This study is a Randomized, Double Blind, Multi-center, Active Drug Controlled,     Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in     Treatment of Post Stroke Upper Limb(wrist, finger, elbow, thumb)Spasticity.   "
102409|NCT01945671|"     Obese women have a higher prevalence of infertility than their lean counterparts. Obesity is     a risk factor for anovulation , including in response to gonadotropin treatment .Further,     even in women who are cycling regularly, obesity is associated with increased     time-to-pregnancy and decreased chance of natural pregnancy.      During obesity or periods of overnutrition, lipid accumulates in nonadipose tissues, notably     skeletal muscle, liver, heart, and pancreas due to cellular uptake of exogenous fatty acids,     triglycerides, and cholesterol as well as de novo lipogenesis in response to elevated     glucose. The accumulation of intracellular lipid leads to high levels of free fatty acids     that are subject to oxidative damage and the formation of cytotoxic and highly reactive lipid     peroxides, which ultimately are detrimental to intracellular organelles, particularly the     endoplasmic reticulum (ER) and mitochondria. Exposure of the ER to high levels of free fatty     acids and lipid peroxides causes structural alterations that perturb ER function and lead to     accumulation of unfolded proteins and calcium release. Failure of the UPR to reestablish ER     homeostasis can lead to apoptosis .When mitochondria are exposed to high levels of free fatty     acids, these can become oxidized by mitochondrial reactive oxygen species, forming lipid     peroxides that damage essential proteins and uncouple mitochondrial function. This results in     mitochondrial damage, which can cause further accumulation of lipids that cannot be     catabolized, disrupted cellular homeostasis, and ultimately apoptosis .      The cellular mechanisms by which obesity causes decreased conception rates are not known.     Based on extensive evidence of obesity-induced lipotoxicity in other cells, it was     hypothesized that obesity results in the activation of lipotoxicity pathways in the ovary. It     was shown that lipid accumulation, ER stress, mitochondrial dysfunction, and apoptosis occur     in ovarian cells and the oocyte in response to a high-fat diet.      The aim of our study was to evaluate the influence of high BMI on oocytes, granulose cells     and metabolites in the follicular fluid.   "
102410|NCT01945658|"     The main objective of this study is to determine what is the vitamin D status in Israeli     women undergo ART. We want to evaluate the influence of hyper Vitamin D level and low vitamin     D level on IVF -ICSI cycles. We will evaluate as well the influence of increased estradiol     level in IVF-ICSI cycles on peripheral vitamin D.      We plan to follow vitamin D in infertile women undergoing IVF treatment for various     indications, at baseline, during and after controlled ovarian hyperstimulation. Their levels     will be measured at baseline (when they first present for basic investigations at our     clinic), during the down-regulation phase of their treatment (if their protocol has a     down-regulation phase), at each follow-up visit during stimulation (when they are asked to     present for measurement of their estradiol (E2) levels), as well as at the conclusion of     their treatment (i.e. the day of their pregnancy test). Along with endocrinology profiles, we     will also record all the details of treatment outcomes in terms of embryo quality,     implantation and clinical pregnancy rates. We also intend to perform follow-up studies of     pregnancy outcomes.   "
102411|NCT01945645|"     A pre-randomized study in primary health care was designed to investigate health education in     a subpopulation extracted from general practitioners (GPs) in one Danish county in the     treatment arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with     Screen-Detected Diabetes in Primary Care) study, DK. The overall objective of the 'Ready to     Act' health education programme was to support the participants' competences in daily life     and act appropriately with respect to their dysglycaemic condition. The achievement of action     competence involved four learning objectives: intrinsic motivation, informed decision-making,     action experience and social involvement. The programme was delivered in primary care     settings (health centre or GP surgeries) by nurses, dieticians, physiotherapists and GPs.   "
102412|NCT01945632|"     In a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one     of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing     with piezoelectric ultrasonic scraper [PU]; or 4) root planing with vertically oscillating     ultrasonic device [VOU]. Post-treatment, the teeth will be extracted and their topography     analyzed in 124 observations with white light confocal microscopy, measuring the roughness     parameters Rp, Rv, Rt, Ra, Rq, Rku, and Rsk.   "
102413|NCT01945619|"     Subjects have a type of blood cell cancer, other blood disease or a genetic disease for which     they received a stem cell transplant. After transplant while the immune system grows back the     subjects have an infection with one or more of three viruses - Epstein Barr virus (EBV),     cytomegalovirus (CMV) or adenovirus - that has persisted or come back despite standard     therapy.      Adenovirus is a virus that causes symptoms of a common cold normally but can cause serious     life-threatening infections in patients who have weak immune systems. It usually affects the     lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the     pancreas and the eyes.      CMV is a virus that can also cause serious infections in patients with suppressed immune     systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also     affect the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people     harbor this virus in their body. In healthy people CMV rarely causes any problems because the     immune system can keep it under control. If the subject and/or the subject's donor are     positive for CMV, s/he is at risk of developing CMV disease while his/her immune system is     weak post transplant.      EBV is the virus that causes glandular fever or kissing disease. It is also normally     controlled by a healthy immune system, but when the immune system is weak, it can cause     fevers, enlarged lymph nodes and sometimes develop into a type of cancer called lymphoma.      This treatment with specially trained T cells (called CTLs) has had activity against these     viruses when the cells are made from the transplant donor. However, as it takes 2-3 months to     make the cells, that approach is not practical when the subject already has an infection. We     want to find out if we can use CTLs which have already been made from another donor that     match the subject and his/her donor as closely as possible and if the CTLs will last in the     body and have activity against these viruses.      In a recent study these cells were given to 50 patients with viral infections post transplant     and over 70% had a complete or partial response. The purpose of this study is to make CTL     lines leftover from that previous study available to patients with viral infections that have     not responded to standard treatments.      These virus-specific CTLs are an investigational product not approved by the FDA.   "
102414|NCT01945606|"     This is a study to investigate the safety and tolerability of the partial A1 agonist     BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single     dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study     is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of     standard therapy for heart failure, particularly ß-blocker treatment.   "
102415|NCT01945593|"     To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the     prevention and treatment of bleeding episodes in previously treated patients (PTPs) (children     and adults from 0 to 75 years of age) with severe hemophilia A.   "
102416|NCT01945580|"     To compare transvaginal repair with a biologic graft to traditional native tissue repair in     women surgically treated for anterior and/or apical pelvic organ prolapse.   "
102417|NCT01945567|"     The posterior subthalamic area holds promise as a target region for deep brain stimulation in     tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide tube     surgical technique, subregions of the posterior subthalamic area can be individually     targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona     incerta may provide improved control of movement disorder symptoms than the more commonly     stimulated dorsal zona incerta.   "
102418|NCT01945554|"     The purpose if this study is to assess the response to nerve root infiltration therapy in     patients with cervical or lumbar disc herniations.   "
102419|NCT01945541|"     The purpose of this study is to evaluate a recently developed device, which measures body     composition (i.e. the water content of the body) in the perioperative setting. Specifically     the investigators will test the hypothesis, that extracellular water content after surgery     correlates to the amount of intraoperative infusion and positive fluid balance. Furthermore     the investigators will test, if preoperative evaluation of body water helps to determine     intraoperative fluid requirements and to guide fluid administration.   "
102420|NCT01945528|"     Background Tendinopathy is a difficult problem to manage and can result in significant     patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but     its efficacy remains controversial. Current experimental research postulates different     efficiency among PRP formulations.Recent reviews showed that most clinical studies in     tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy     of pure-PRP in the management of epicondylitis.      The investigators hypothesized that pure PRP associated to needling intervention can enhance     tendon healing in epicondylitis, improve function and reduce pain.      Methods and design Randomized double blind controlled trial, a total of 80 patients will be     randomly allocated into one of two groups: PRP or control. Interventions: PRP group,     ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate     week for a total of two interventions. Control Group: US-guided needling with lidocaine each     alternate week for a total of two interventions. Main outcome measure: Changes in pain and     activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome     measure score, before and six months after intervention.The primary end-point is 25%     reduction in DASH. The investigators will compare the percentage of patients, in each group,     that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.      Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in     pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up.     Changes in sonographic features and neovascularity at 3, 6 and 12 months.   "
102434|NCT01945346|"     This is an exploratory study to evaluate a new anti-inflammatory drug, PRX167700, in subjects     with painful osteoarthritis of the knee.      The purpose of this study is to investigate if PRX167700 improves the pain from     osteoarthritis of the knee, and to assess its safety and tolerability. The study will also     investigate PRX167700 pharmacokinetics.   "
120716|NCT01705834|"     This study will investigate if an electronic dataglove can be used to measure joint stiffness     in patients with Rheumatoid Arthritis.   "
102424|NCT01945476|"     Normally, higher levels of preoperational stress or anxiety affect behavior and recovery     after the operation. Moreover, patients undergoing mastectomy are usually young women, and     this demographic is known to experience higher levels of stress and anxiety than any other.     Anesthetizing patients involves more than just anesthesia in operation; it also includes all     of the preoperative treatments for optimizing a patient's condition and promoting quick     postoperative recovery. Pharmacological premedication for anxiolysis or amnesia before     anesthesia has been a common means of sedation that many studies have investigated. However,     such studies have focused on alleviating patients' anxiety and on how far patients can obey     induction for sedation; there has been no research on post-operational prognoses, the     ultimate purpose of reducing anxiety.      The well-known effect of pharmacological premedication is to reduce the capacity of the     anesthetic. However, it is not confirmed whether this effect leads to better recovery after     anesthesia, as this question has not been researched. Furthermore, recently some have argued     strongly that premedication actually prolongs recovery and that it does not need to be     applied to every patient. Recently, therefore, the use of pharmacological premedication has     been left to the discretion of institutes or doctors in many cases.      Among types of premedication, midazolam belongs to the class of short-acting benzodiazepines     and is frequently used, as it induces meaningful anterograde amnesia and causes fewer     aftereffects such as respiratory problems. In addition, its effects have already been     demonstrated. However, research on the improvement of functional health after     anesthesia—i.e., patients' quick return to normal life—is still poor and needs to be     advanced.      When measuring the degree of recovery, recent studies tend to focus on measuring how quickly     patients are able to return to normal life rather than the recovery of specific symptoms. To     this end, the most widely used method is the Quality of Recovery 40 (QoR-40) survey. It has a     total of 40 items, which are classified into five categories: emotional state, physical     comfort, psychological support, physical independence, and pain. Questions are answered using     a 5-point scale, with 1 being worst and 5 being best. It takes 6.3 minutes on average to     complete, and its test-retest reliability, internal consistency, and split-half coefficient     have led it to be recognized as the most effective survey method. Moreover, it has been used     in many studies investigating how the type of operation, method of anesthesia, additional     medication, and gender affect anesthesia and the operation. Its validity for such research     has been verified.      Therefore, investigators can investigate the degree of postoperational functional recovery     through the QoR-40 by comparing cases in which an operation is performed with or without     midazolam.   "
102425|NCT01945463|"     Breast augmentation surgery is currently the most common elective plastic surgery performed     in the US. With regards to the surgical technique, there are 4 incisional sites available for     breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar,     inframammary, and umbilical. The implant is inserted in either a subglandular (beneath breast     tissue), submuscular (underneath the Pectoralis Major), or dual-plane (combination of both)     manner.      Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation     of cardiac structure and function. Its use has increased dramatically in the last decades. We     have encountered three women with congenital heart disease who have undergone breast     augmentation, and their echocardiographic images were significantly limited after the     implantation. There is only one case report in the medical literature suggesting that breast     implants interfere with echocardiographic views .      The underlying physical property of the silicone breast implants that causes interference     with the ultrasound beam during echocardiographic examination is not known and has not been     studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear     to prevent penetration of ultrasound beams. The poor penetration appears to be persistent and     unrevealing despite increase in gain or change in the ultrasound wave's frequency.      Many women elect breast augmentation for cosmetic reasons. Women with congenital heart     disease who have undergone cardiac surgery may have breast asymmetry or distortion and desire     augmentation accordingly.      Knowledge of the extent of impairment of breast implants to the echocardiographic examination     is important for few reasons:        1. Women with heart disease who need echocardiographic follow up and wish to undergo breast          augmentation should be consulted as to the limitation of the echocardiographic          examination following the procedure.        2. Women without heart disease considering breast augmentation should be informed of          potential echocardiographic interference, if echocardiography be needed in the future,        3. Different surgical techniques may cause different masking effect.        4. Different implants size and shape may cause different masking effect.   "
102426|NCT01945450|"     Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in     manual revision of the uterus after labor in cases of residual placenta.      Methods: a randomized control trial in which parturients for which the placenta was not     separated or there is a suspected residual placenta will be divided randomly to two groups:     (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus     or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2     grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3. In cases of allergy to Penicillin the     antibiotic regimen will be: Gentamycin 240 mg*1, Clindamycin 600 mg*3.      Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent     hospitalization in the first 2 weeks after discharge.   "
102427|NCT01945437|"     The hypothesis of this study is that in staged bilateral total knee arthroplasty (TKA,     magnesium sulfate administered during the perioperative period of the first TKA may decrease     pain after the second TKA. It is known that pain is greater in the second TKA than in the     first. Therefore, we compared pain of the second TKA between the magnesium and control     groups.   "
102428|NCT01945424|"     The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a     prospectively recruited pregnancy surveillance program designed to collect and analyze     information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.   "
102429|NCT01945411|"     The purpose of this study is to assess the facial measurements for determining the proper     sizes of oropharyngeal airway. Investigators hypothesized that the length between incisors     and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared     with the length between mouth corner and mandible angle.   "
102430|NCT01945398|"     This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory     muscle metaboreflex through the decrease of calf vascular resistance and increase of calf     blood flow in Chronic Obstructive Pulmonary Disease (COPD).   "
102431|NCT01945385|"     Primary: To compare rates of immediate postabortal LARC uptake between women exposed to a     brief, theory-based, video intervention prior to standard contraceptive counseling and women     exposed to standard counseling alone.      Secondary: To identify predictors of immediate postabortal LARC uptake among all participants     including the role of:        -  Demographic and reproductive health history variables        -  Baseline decisional balance, self-efficacy and stage of change for contraceptive          initiation   "
102432|NCT01945372|"     Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and     irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to     patients' functioning and quality of life, ~40% do not respond to conventional treatment     options.      In this study, the investigators aim to examine a novel therapeutic approach for the     treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF)     probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a     real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after     training period. Comprehensive psychological assessment will be performed for outcome     measure. The investigators hypothesize that EEG-NF treatment will enhance affective     stability, thus improving patients' daily lives.   "
102433|NCT01945359|"     This study will observe participants with relapsing remitting multiple sclerosis who are     switching therapies from natalizumab to dimethyl fumarate to determine disease stability.   "
102818|NCT01940341|"     The primary objective of this study is to compare the efficacy, safety, and tolerability of     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and     treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B     virus (HBV) infection.   "
102436|NCT01945320|"     A prospective long-term follow up of hemodialysis (HD) patients' outcome correlates with     nutritional status and body composition. We will evaluate the body composition change among     HD patients every three months with bioelectrical impedance analysis (BIA). The change of     body composition will correlated with other clinical data including nutritional, inflammatory     parameters and survival.   "
102437|NCT01945307|"     We need human blood to understand the immune response to infection and to test promising new     vaccines against infectious diseases in the laboratory. One test is called the Serum     Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing     certain bacteria and can be an important measure of how effective a new vaccine may be.      The samples would be used in the laboratory analysis of clinical trials of vaccines used in     adults and children, and some samples in pre-clinical (animal) experiments testing new     vaccines before they enter human-stage testing. Most people have some form of protection     against most bacteria already, so not everyone is a suitable blood donor for this laboratory     test. We therefore start by taking a small blood sample and test this one before asking for     more blood if we found yours suitable for the work we do.   "
102438|NCT01945294|"     The purpose of this study is to estimate the difference in the efficacy between a 16-week     treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus     ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated     participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable     hepatitis C virus ribonucleic acid (HCV RNA).   "
102440|NCT01945268|"     A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular     events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or     placebo and followed prospectively over three influenza seasons. 600 participants will be     enrolled prior to influenza season and randomized to either influenza vaccine or saline     placebo.   "
102441|NCT01945255|"     Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage     renal disease (ESRD), which means that it is important to find out risk factors of CVD in     order to prevent or treat it. In recent years, there has been more and more recognition of a     very high prevalence of CV calcification in the ESRD population. Many observational cohort     studies have shown that CV calcification in these patients can predict mortality, CV     mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may     result in vessel calcification. Calcification leads to arterial stenosis and increasing     arterial stiffness and then heart afterload, both contribute to the development of CVD.     Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic,     immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent     in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis     would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly     associated with the presence and extent of atherosclerosis and constitutes a forceful marker     and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery     occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which     would increase the condition of infection and gangrene. Thus, life safety and quality would     be influenced severely and early detection might prevent future amputation. Uremic patients     also have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the     condition of arterial stiffness and PAOD, especially in HD patients, are needed for future     management and preventions of CV related morbidity and mortality.   "
102442|NCT01945242|"     The purpose of this study is to determine the safety and efficacy of long-term combination     therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes     mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to     diet therapy and exercise therapy.   "
102443|NCT01945229|"     Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of     the western population. It may cause symptoms such as irregular heartbeats, shortness of     breath, and fatigue. It may also be asymptomatic (ie silent atrial fibrillation). In some     cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of     symptoms, there is an increased risk of stroke in some patients with this condition. Novel     technologies are being developed to increase detection of silent atrial fibrillation, in     order to find patients who might benefit from treatment with oral anticoagulants     (blood-thinning medications) in order to reduce the risk of stroke. One of these technologies     is thumb-ECG, a simple way for a patient to have his or her heart rhythm reliably analyzed at     home.      Hyperthyroidism (sometimes referred to as toxic goiter) is defined as an excessive     production of thyroid hormone. It is known that hyperthyroidism may cause atrial fibrillation     in about 8% of cases.      Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating     their hormonal disturbance, in order to find episodes of silent atrial fibrillation.      Design: Prospective observational study.      Hypotheses:        -  Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial          fibrillation in hyperthyroid patients.        -  Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared          to the normal population even after hyperthyroidism is treated.        -  Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial          fibrillation are at increased risk of stroke and should be considered for treatment with          oral anticoagulants.   "
102444|NCT01945216|"     The purpose of this study is to determine the safety and efficacy of long-term treatment with     alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to     diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy,     and α-glucosidase inhibitor.      In addition, examining the safety and efficacy of alogliptin in patients with renal     impairment, information on the appropriate dosage of alogliptin according to the severity of     impaired renal function should be collected.   "
102832|NCT01940146|"     The study will assess the efficacy and safety of SPARC1310 when compared to placebo and     active control   "
102479|NCT01944761|"     The objectives of our proposed study are to (a) evaluate the feasibility of conducting a     structured exercise program in children treated with cranial radiation for brain tumors, (b)     test whether exercise results in improved thinking skills and emotional function, and (c)     examine potential mechanisms of improved outcome, particularly recovery of white matter and     grey matter.   "
102445|NCT01945203|"     Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage     renal disease (ESRD), which means that it is important to find out risk factors of CVD in     order to prevent or treat it. In recent years, there has been more and more recognition of a     very high prevalence of CV calcification in the ESRD population. Many observational cohort     studies have shown that CV calcification in these patients can predict mortality, CV     mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may     result in vessel calcification. Calcification leads to arterial stenosis and increasing     arterial stiffness and then heart afterload, both contribute to the development of CVD.     Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic,     immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent     in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis     would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly     associated with the presence and extent of atherosclerosis and constitutes a forceful marker     and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery     occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which     would increase the condition of infection and gangrene. Thus, life safety and quality would     be influenced severely and early detection might prevent future amputation. As compared with     HD or pre-dialysis patients, uremic patients treated with PD have a higher risk for metabolic     syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD,     especially in PD patients, are needed for future management and preventions of CV related     morbidity and mortality.   "
102446|NCT01945190|"     Acupuncture is used extensively by patients worldwide for a variety of illnesses. While     research is beginning to show effectiveness in clinical pain, the mechanisms underlying how     these effects are evoked are poorly understood. Experimental models in healthy human     volunteers can more closely control the variables of acupuncture needling and begin to     separate out the relative contribution of specific components of needling and needle     stimulation. By examining acupuncture's effects on experimental inflammatory models with     well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding how     acupuncture produces its clinical effects. We propose to establish a model which could be     used as a template to examine the individual components contributing to acupuncture's     clinical effects on inflammation and pain. We hypothesize that acupuncture will have     analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well     as a model of heat pain testing which activates central sensitization.      Twenty healthy human volunteers will participate in a crossover study with active acupuncture     and sham acupuncture interventions. They will be tested for their minimal erythemal dose     (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be administered on the     lower leg. Background information will be collected which could affect individuals'     sensitivity to pain such as anxiety and depression, as well as their expectations regarding     acupuncture treatment.      The following day they will return for the first experimental day. A measurement with Laser     Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will be     performed using a computer controlled thermode both on and off the ultraviolet B lesion.     On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal     summation of heat pain.      Next, a licensed acupuncturist will perform either true electroacupuncture or sham     electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are     blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler     and heat pain testing will be repeated. The difference between pre-acupuncture and     post-acupuncture measurements will represent the acupuncture -induced analgesic and     anti-inflammatory effects.      Participants will return for another ultraviolet B exposure adjacent to the first, and will     receive whichever sham or true acupuncture intervention was not performed on the first study     day.   "
102447|NCT01945177|"     It is recognized that gastroscopy can miss intestinal metaplasia, dysplasia and early gastric     cancer. This could conceivably be due to the fact that these lesions may only present as     subtle mucosal changes on conventional white light endoscopy (WLE) and thus be easily missed.     In narrow band imaging (NBI) a rotating interference narrow band filter is interposed after     the xenon light source such that when the NBI mode is switched on, discrete blue and green     wavelengths are used and this improves mucosal surface contrast and facilitates visualization     of mucosal details. A new NBI system is available that allows brighter illumination. We     hypothesize that bright -NBI is superior to WLE in detecting focal gastric lesions such as     gastric intestinal metaplasia, dysplasia and early gastric cancer in subjects undergoing     gastroscopy.   "
102448|NCT01945164|"     Cancer is a worldwide clinical and economic problem. Conventional approaches to treating     cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as     combined therapies. Recently, targeted therapies including antibodies and small molecule     inhibitors have also demonstrated clinical benefit. It is now possible to study different     genetic lesions involved in cancer types due to advances in genomic methodologies. The     investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases,     including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ),     fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1,     FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously     and will likely have effects on the integrity of tumor neovasculature and angiogenesis.     Together with the ability to induce a novel cell cycle arrest, the spectrum of activities     that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic.      The rationale and purpose of this maintenance study is to allow a subject receiving clinical     benefit from XL999 to continue treatment.   "
102449|NCT01945151|"     To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in     the agonist and antagonist muscles of spastic hemiparetic patients.      The specific objectives are:        -  Evaluate the resistance movement, strength and muscle electrical activity before and          after application of Neuromuscular Electrical Stimulation in spastic muscle          (gastrocnemius).        -  Evaluate the resistance movement, strength and muscle electrical activity before and          after application of Neuromuscular Electrical Stimulation in the spastic antagonist          muscle (tibialis anterior).        -  Compare the risk of falls after application of Neuromuscular Electrical Stimulation in          both muscles studied.   "
102450|NCT01945138|"     The purpose of this study is to determine the effectiveness of closed loop insulin pump     therapy to control blood sugar following total pancreatectomy and islet auto-transplantation     (TPIAT).   "
102451|NCT01945125|"     To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during     radioiodine therapy in renal function.   "
102452|NCT01945112|"     Friction foot blisters are one of the most common and often debilitating complaints of all     athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor     hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether     applying paper tape to the areas of the foot where blisters historically occur in endurance     runners can prevent the incidence of friction blisters.   "
102833|NCT01940133|"     This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and     the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.   "
102453|NCT01945099|"     Closed loop artificial pancreas systems have been under development for the control of     blood sugars in those living with diabetes. These systems consist of a continuous glucose     sensor, which sends a signal to a computer program that automatically determines how much     insulin to give. The computer program then tells an insulin pump to deliver the insulin.     While such systems have been tested under a number of conditions, post-meal blood sugars are     difficult to control. Specifically, we will be looking to see if using hyaluronidase improves     the ability of the closed loop artificial pancreas to better respond to meal related highs     and lows.   "
102454|NCT01945086|"     The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab     compared with placebo (inactive medication) in adult Japanese participants with severe atopic     dermatitis.   "
102455|NCT01945073|"     Increased knowledge about an illness can increase self-management among those afflicted. In     order to facilitate people with sickle cell disease living a longer and healthier life, they     should be taught to manage their illness.An adolescent with a chronic illness has many unique     challenges, in addition to maneuvering the turbulent adolescence period itself. It has been     that better knowledge and more positive perceptions of their illness equate not only to     better control of their illness but also better quality of life.Studies have also shown the     benefits of self-management: when patients are responsible for managing their own illness,     their clinical outcomes and quality of life improve and they become less dependent on health     care services.      In this study we aim to examine if knowledge, and any changes in knowledge, will each have     any association with Quality of Life (QOL) and their perceptions of their illness (IP). We     also seek to investigate the effects of an educational booklet, as well as an intervention     including the educational booklet with formal counselling on their knowledge, QOL and IPs.   "
102456|NCT01945060|"     The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully     control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a     hospital setting. Investigators will also be studying to see if the heart rate informed     Control To Range (hrCTR) can improve the performance of the system during and immediately     after exercise.   "
102457|NCT01945047|"     Depression carries the largest burden of all medical disorders in middle to high income     countries, as determined by the World Health Organization. Despite many antidepressant     strategies, only a third of patients get well after their first treatment and a third remain     ill after several treatments. Moreover, antidepressant treatments all have a delayed action     ranging up to several weeks.      Ketamine (KET) has been used for decades as a sedative and anesthetic. In treatment-resistant     depressed patients(TRD), an intravenous dose much lower than necessary for anesthesia may     produce a robust antidepressant effect and may even abolish suicidal thoughts within hours,     peaking within 24 hours. But, its antidepressant effect generally lasts only days.Previous     studies examining KET in TRD have been critiqued for lack of an effective placebo measure due     to brief perceptual experiences associated with KET. Thus, the current study compares KET     against a short-acting sedative. The phases of this study compare response to a single KET     injection to 6 injections over 2 weeks. Next, KET responders are given 1 injection a week for     3 weeks of either KET or the sedative agent to determine if beneficial effects of KET are     maintained, and to assess duration of its benefits after repeated administration. The genetic     profile of patients for a substance promoting contacts between cells and brain will be     determined to investigate if response to KET could be predicted with that blood test. This     substance, as well as several chemicals that produce inflammation, will also be measured in     the blood to investigate their role in the effect of KET. Patients will receive, in total, no     more than the equivalent of two to three anesthetic dose of KET. Results from this study will     help establish the beneficial effects of a single KET injection as a rapid intervention for     major depression, and to investigate the possibility of obtaining a prolonged antidepressant     effect with repeated injections.   "
102458|NCT01945034|"     This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical     placebo for the relief of pain associated with a first or second degree ankle sprain. Both     twice daily and three times daily regimens will be evaluated.   "
102459|NCT01945021|"     To assess treatment effectiveness and safety of oral crizotinib administered to East Asian     patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive     for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an     ALK mutation   "
102460|NCT01945008|"     HCV infection is the most frequent cause of liver chronic disease, cirrhosis and     hepatocellular carcinoma in western countries.      To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus     ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and 4,     and is associated with important adverse side effects, that lead to treatment interruption in     approximately 30% of cases.      The recent association of first generation HCV- specific direct-acting antiviral agents     (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates,     also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV.     While several new DAAs are in development, the ultimate goal is represented by IFN-free     regimens, that will provide a great advantage in terms of patients adherence to therapy and     quality of life.      In this context, prospective observational studies are needed to evaluate the real and     long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety,     costs and impact on patients quality of life.      The Italian context      Italy is the European country with the greatest number of HCV infected people (average, 3% of     population), with higher prevalence in the center and in the south of the country, especially     in older individuals, and the highest mortality caused by hepatocellular carcinoma. Genotype     1 is the most frequent one (in more than 50% of infected people). DAAs were approved at the     end of 2012. For these reasons, Italy represents an interesting context for collecting data     on long-term efficacy, safety and tolerability of new anti-HCV treatments.      The PITER cohort study, developed in the frame of Italian Platform for the study of the     therapy of viral hepatitis a prospective observational study, is based on a large cohort of     HCV infected patients from more than 100 clinical centers distributed on the whole national     area (we can provide a list on demand).      The PITER cohort study will provide exhaustive information on:        -  Clinical and virologic natural history of all enrolled patients        -  Therapeutic outcomes in different clinical/virologic contexts and in special populations          starting a new treatment (i.e. Predictors of virological response, disease progression          or fibrosis regression        -  quality of life of patients        -  pharmacokinetics of drugs and pharmacological interactions        -  Short, middle and long term side effects        -  Minimum duration of therapy to reach the sustained virological response        -  Aspects related to personalization of treatment in specific populations: old people,          women, immigrants or marginalized populations, patients not responding to standardized          treatment protocols, patients waiting for liver transplantation or transplanted patients        -  Role of viral variability in the natural history of the disease and in the response to          treatment        -  Pharmacoeconomics and risk-benefits analysis. All these information will be used to          evaluate prescription appropriateness in Italy, with important implications for public          health..      PITER may also represent a starting point and a base for future clinical studies,     contributing to the optimization of therapeutic protocols and to the formulation of     guidelines on the use of new therapies for HCV treatment   "
102461|NCT01944995|"     Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is     also more and more used in infants with severe acute bronchiolitis. There is no evidence that     nCPAP improves outcome, but several studies showed that it reduces work of breathing (WOB),     improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP) therapy,     also used in neonatal units, has recently been suggested for bronchiolitis management. This     technique allows warmed and moist gas administration protecting nasal mucosa, and preventing     variations of inspired gas FiO2. HFNP also creates a continuous positive pressure, reducing     WOB, and seems much more comfortable and better tolerated by babies than nCPAP. There are no     studies comparing both techniques for bronchiolitis management. The main objective of this     study is to compare WOB with nCPAP and HFNP therapy in infants with severe bronchiolitis in     pediatric intensive care unit. Secondary purpose is to compare efficacy and tolerance of both     techniques. We propose to lead an open, single center, crossover randomized study. Each     patient will receive the two treatments. Three consecutive periods will be studied: first one     (minimum 2 hours), with the first technique CPAP or HFNP according to randomization     (treatment 1); second period (2 hours) with the second technique (treatment 2); Third period     (6 hours) with the second technique. The primary endpoint will be the comparison of WOB     (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of     the two firsts periods. Efficacy and tolerance of each technique will be evaluated and     compared by compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2,     modified Wood score, and EDIN score during the third period. Nine subjects by groups are     required.   "
102462|NCT01944982|"     To determine safety profile of immunotherapy with natural killer cells and activated expanded     (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic     leukaemia and lymphoma.   "
102463|NCT01944969|"     To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in     patients with Major Depressive Disorder (MDD)   "
102464|NCT01944956|"     Our objective was to evaluate maturation of sucking and swallowing in preterm infants using a     non-invasive method: assessment of swallowing sounds. Findings in healthy term infants were     used as reference values.   "
102465|NCT01944943|"     The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of     patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL).   "
102466|NCT01944930|"     Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or     gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered     participation in the study. The proposed study is a randomized, controlled feasibility trial     with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic     narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of     peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the     peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI.     The order of white-light and NBI laparoscopy will be randomized for each patient (crossover     design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing     abnormalities using best clinical practices. The number of detected peritoneal metastases     will be compared between each diagnostic laparoscopy technique. To gauge the rate of     potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year     follow-up.   "
102467|NCT01944917|"     Previously it has been demonstrated that exposing the heart to electromagnetic field during     exercise stress test improves the recovery following the stress test. This is explained by     the effect of the electromagnetic field on the sympathetic activity of the heart. In the     present study we would like to further investigate the effects of electromagnetic field on     autonomic nervous system function in patients with chronic musculoskeletal pain that usually     have high sympathetic activity. Each patient will be exposed to 20 minutes of electromagnetic     field during which the autonomic nervous system function will be measured. In addition,     patient tolerability to the exposed magnetic field will be investigated. We assume that short     exposure to electromagnetic field would result in decreased sympathetic activity and     therefore, on the long run, could be suggested as a therapeutic tool for such patients.   "
102468|NCT01944904|"     This study aims to determine whether the use of a supplement called xylooligosaccharide (XOS)     increases the number of good bacteria that live in human intestines and can maintain healthy     blood sugar levels, and whether XOS has any unpleasant or unexpected side effects when     consumed at different dosages. Subjects who participate in this study will be randomized to     receive an eight week supply of either a lower dose of XOS or placebo (no active substance).     This will be determined randomly, in a process similar to flipping a coin. Blood samples will     be taken at each visits, including an oral glucose tolerance test. Subjects will also be     asked to collect and bring in stool samples at three different time points during the study.      Subjects will have a 50/50 chance of being assigned to the either study group. This is a     double-blind study which means neither the study investigator nor the subject will know to     which group he/she has been assigned. In case of an emergency, the study doctor can get this     information.   "
102469|NCT01944891|"     Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique     was collected. A cross-sectional study was carried out in 2010 in two seasons,     January-February and May-June. Participants (total n=551) were recruited from Quelimane (the     provincial capital), Maganja da Costa district and Morrumbala district.   "
102470|NCT01944878|"     The aim of this study is to assess the role of portal hypertension of peptic ulcer disease in     liver cirrhosis and chronic hepatitis.   "
102471|NCT01944865|"     The aerobic fitness is important for mountain bikers, but riders should also be able to     generate maximal and supramaximal efforts in some crucial phases of the competition. Although     there is an increase interest in high-intensity aerobic training, to investigators knowledge,     there are no studies examining the effects of interval (INTV) or intermittent training (INTM)     in mountain bikers. The aim of this study was to compare the effects of INTV and INTM on     aerobic fitness variables (peak power output, Wmax, lactate threshold, and onset of blood     lactate accumulation) but more importantly on performance as measured using a controlled     mountain bike race, i.e. simulation. The investigators hypothesized that INTV and INTM     training were equally effective in improving Wmax, Lactate threshold and onset of blood     lactate accumulation, but INTV was superior in enhancing performance in mountai bike race     simulation.This hypothesis is due to studies that have shown higher gains in performance with     long duration of aerobic high intensity interval training in comparison to the shorter     training at a higher intensity.   "
102472|NCT01944852|"     The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in     incident CAPD patients aged of 65 at minimum :        -  One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose        -  One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.   "
102473|NCT01944839|"     The objectives of this study are to evaluate the safety and efficacy of intravitreal     administration of Fovista® administered in combination with Lucentis® compared to Lucentis®     monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related     macular degeneration (AMD).   "
102474|NCT01944826|"     Prospective, multicenter, observational registry collecting data from subjects with     Tako-Tsubo (stress-induced) cardiomyopathy (TTC). Uniform, complete, and accurate data will     be collected on the subject's medical history, during index hospitalization for TTC, and     during follow-up.      The objectives are to evaluate the prevalence and incidence of cancer in patients with TTC,     to document the underlying causes of death during hospital stay and during follow-up, to     determine the long-term prognosis, and to identify possible predictors of short and long-term     mortality.   "
102475|NCT01944813|"     Communication about end-of-life issues is often suboptimal. A way to improve the quality of     end-of-life care is Advance Care Planning (ACP). ACP is a discussion between an incurable ill     patient and the health professionals about preferences for end-of-life care. In Denmark,     there is no tradition of systematic communication with patients about end-of-life care. The     aim is to investigate how ACP can be beneficial among incurable ill patients treated in an     outpatient context and if the concept is feasible in a Danish context. The study is designed     as a prospective randomised controlled trial. Patients from relevant departments will be     included and randomised in two groups: one receiving usual care and the other receiving usual     care and ACP. Data will be collected from Electronic Patient Files and from questionnaires.     If ACP is effective, it will improve the quality of end-of-life care for patients and their     families and reduce the psychological distress in the bereaved relatives.   "
102476|NCT01944800|"     Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether     ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned     invasive strategy in terms of clinical outcomes.   "
102480|NCT01944748|"     The goal of this project is to conduct a pilot evaluation of a parent-child mediation program     for at-risk youth. It is investigating whether families who receive parent-child mediation     show greater improvement in family functioning, as well as adolescent substance use, academic     performance, and delinquency, over a 6-week and 12-week period compared to a wait-list     control sample.   "
102481|NCT01944735|"     The purpose of this study is to assess the safety and tolerability of multiple oral doses of     CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days.This     study will include two dose levels. For each dose level, blood samples will be collected for     exploratory PK and PD assay validation. In addition, sputum will be collected for exploratory     biomarker analysis. Following multiple dose administration, pulmonary function and     exploratory lung clearance index (LCI) measurements will be taken.   "
102482|NCT01944722|"     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human     Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media     diluted in HPV diluent to adjudicated histology results from biopsy.   "
102483|NCT01944709|"     The prognosis of patients with metastatic melanoma is poor and current available treatments     are limited. Identification of a number of melanoma-specific tumor antigens that are shared     by tumors from different patients, provides attractive targets for immune-based therapies     (http://www.bioinfo.org.cn/hptaa/). Different approaches like DNA-/RNA-vaccines, peptide     vaccines and dendritic cell (DC) vaccines are under investigation to induce peptide-specific     immune responses. In various animal models and in clinical trials it was shown that the most     potent induction of anti tumor-specific killer cells was achieved with DC vaccination. DCs     are professional antigen presenting cells (APC) that are critical in the initiation of     cellular responses in naïve T lymphocytes, in vivo. They are armed with all the molecules     needed for the induction of immune responses and have the capacity to migrate into secondary     lymphatic organs. In vitro generated dendritic cells are loaded with tumor derived peptides     and injected subcutaneously. The concept is to induce or to propagate already existing tumor     specific killer T cells.   "
102484|NCT01944696|"     Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted)     phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth     weight newborns in a pilot randomized controlled trial.      Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous     phototherapy in extremely low birth weight (ELBW) infants without the risks that have been     associated with continuous phototherapy.   "
102485|NCT01944683|"     The study will examine midazolam pharmacokinetics following single dose administration of 3     planned dose levels of GGF2 .   "
102486|NCT01944670|"     The purpose of this study is to confirm the safety and effectiveness of the Internal Joint     Stabilizer - Elbow.   "
102487|NCT01944657|"     A. Introduction to the Problem      This field experiment is intended to explore whether supplemental transcranial magnetic     stimulation (TMS) is more effective than standard medication mono-therapy for the treatment     of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the     practice guidelines of the American Psychiatric Association for the treatment of major     depression.      B. Importance of the Area of Study      The safety, efficacy and value of TMS treatment has been established through the four-phase     FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer     reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict     enrollment and methodological requirements. TMS is now used in actual clinical practice and     there is an opportunity to extend laboratory research and typical, highly controlled field     settings to applied settings. This study is designed to gather data on safety, efficacy and     utility of TMS as it is used in clinical practice.      C. Need for Additional Research      Efficacy and safety of these interventions have been scientifically established and     meta-analyses of these studies underscore the efficacy and safety of two treatment     interventions to be employed in this study: 1) standard medication monotherapy and 2)     standard medication therapy supplemented with TMS. However, many authors conclude that     depression can be difficult to treat and there is an ongoing need for additional research.     Depression remains a major public health problem.   "
102488|NCT01944644|"     This is a double-blind, randomized, sham-controlled phase II study of the effects of Low     Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major     Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind     treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting     state fMRI will be performed at baseline and following the third and final treatment session.   "
102489|NCT01944631|"     The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on     cold symptoms. The effect of treatment on the duration of the cold and the patients viral     load plus cytokine level indicating the inflammatory response will be analyzed.   "
102490|NCT01944618|"     The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly     been prescribed Forxiga for the management of glycemic control   "
102491|NCT01944605|"     Out-of-hospital cardiac arrest (CA) is a leading public health problem causing nearly one     third of a million deaths annually in the US, accounting for half of all cardiovascular     deaths and surpassing deaths from stroke, heart failure, and breast and lung cancer combined.     Twenty to fifty percent of CA patients (pts) can be resuscitated initially but many die     before hospital discharge or suffer permanent neurologic damage. Therapeutic hypothermia (TH)     improves survival and neurological outcomes. Despite aggressive, targeted post arrest     management, including TH, approximately 50% of pts die before leaving the hospital due to     global ischemia-reperfusion injury (IRI) known as the post arrest syndrome, 1 which is a     sepsis-like state characterized by elevated markers of cellular inflammation and injury. It     is believed that TH works by decreasing the body's basal metabolic rate (BMR) and attenuating     the systemic inflammatory response (SIR). However, specific triggers of the intense     pro-inflammatory response are unclear. This gap in knowledge must be closed to identify     targeted therapy to decrease IRI and improve outcomes.      Blood flow to the gut is decreased markedly and intestinal tissue becomes ischemic during CA     and CPR, particularly when vasoconstrictor drugs such as epinephrine, are given. IRI of the     intestine increases intestinal permeability leading to intestinal microbial translocation and     endotoxin release that can stimulate and perpetuate systemic inflammation and cause     subsequent multi-organ dysfunction. Endotoxin also increases body temperature and energy     expenditure and may attenuate TH induced reductions in BMR and hence, decrease efficacy. The     purpose of this novel pilot study is to detect systemic endotoxin release following CA in     humans and determine association with cytokine activation, and BMR alterations during TH.   "
102501|NCT01944475|"     Precocious puberty - the onset of signs of puberty before 8 years of age in girls - is be     physically and emotionally devastating for kids and is sometimes caused by an underlying and     medical condition. One sign of precocious puberty in small girls is breast development     (thelarche). This can persist without other physical changes of puberty, it may continue into     precocious puberty, or it may disappear. This project will improve the diagnostics of     precocious puberty in girls and improve our ability to identify which girls with thelarche,     who will develop precocious puberty and need medical treatment.   "
102671|NCT01942265|"     This Phase II randomized, double-blinded, controlled study in up to 1000 males and     non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all     eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen     derived from the influenza A/Shanghai/2/2013 virus.   "
102782|NCT01940822|"     This study is being done to look at the cardiovascular response, if any, to intake of     commercially available energy drink. We hypothesize that energy drink consumption compared to     a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus of     this study is to elucidate the physiological/cardiovascular response to an energy drink     consumption as compared to a control drink both at rest and during stressful conditions in     healthy adults.   "
102492|NCT01944592|"     Physical examination of the pelvis is an important core skill that medical students need to     acquire. However, due to its intimate nature some students are graduating unable to perform     competent pelvic examinations. Gynaecological Teaching Associates (GTA's) are women who have     been trained to be examined and give valuable feedback to the students. In North America     GTA's are quite commonly used in the medical curriculum and they have also been used in     Canada, Australia and Scandinavia. In the UK pelvic examination is mainly taught using a     combination of clinic patients, pelvic models and patients anaesthetised for surgery. In     Birmingham we have already started using GTA's and like other Universities such as Oxford the     students have given positive feedback.      GTA's are paid professionals and hence introducing this method of teaching has financial     implications for Universities. Unless it is proven to be worthwhile it is unlikely that     academic institutions will introduce and maintain GTA programs. One UK study did show that     those who had been trained with a GTA's and pelvic models were significantly better than     those who had been trained with pelvic models alone. However, in this study the GTA training     was supplementary to the normal curriculum so the amount of teaching rather than the style of     teaching may have acted as a confounding factor. Therefore, a large randomised trial of     trainees on the Obstetrics and Gynaecology (O&G) programme comparing those given an initial     teaching session on a pelvic model and those taught by GTA's is needed to assess the     effectiveness of GTA's on confidence and competence of the students by the end of the     training programme is needed.   "
102493|NCT01944579|"     Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce     smaller molecules which may impact health. In addition, evidence suggests that this process     may be affected by body fatness. This study aims to investigate absorption of blackberry     polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal     bacteria, and how these processes differ for obese and lean individuals. It is hypothesized     that polyphenol absorption and metabolism will differ between obese and lean individuals and     that differences in intestinal microbiota may play a role.   "
102494|NCT01944566|"     The malodour generation of a person's armpit is caused by the bacteria thriving on that     armpit. In order to alter or reduce once bad body odour, the living microbial community on     the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to     the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the     bacteria living on the armpit is examined by means of molecular techniques. The microbial     transplantation and its follow-up happens under the supervision of a medical doctor.   "
102495|NCT01944553|"     The main objective of the study is to evaluate the feasibility of using the robotic assisted     device ROSA™ for pedicle screws placement. This device is currently used in cranial     neurosurgery but its applications can be extended to other fields, such as spinal surgery. In     the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and     safety of surgery for the patient.   "
102496|NCT01944540|"     This study is aimed to analyze the outcomes after conventional endoscopic submucosal     dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more     than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk.      Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed     circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in     diameter with snaring, then resected by using an electric current.      The investigators expect optimized ESD with snaring can provide more time-saving procedure     with comparable en-bloc resection rate and perforation rate, when compared with the     conventional ESD method.   "
102497|NCT01944527|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of     direct-acting antivirals therapy in liver transplanted patients who experienced HCV     recurrence.      This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective     collect of biological and clinical data's in the liver transplanted patients with recurrent     HCV infection and treated with direct-acting anti-HCV agents.   "
102498|NCT01944514|"     Worldwide three million people a year die from sudden cardiac death (SCD). In most cases     there is no warning and the heart is stopped by a sudden arrhythmia. We know that some people     are at high risk of sudden cardiac death and can prevent their deaths with an implantable     cardioverter defibrillator (ICD) that is implanted in a minor operation.      However, most people who die from sudden cardiac death are not found to be at high risk by     our current risk markers and 40% of the people who have ICDs do not have therapy within the     first 4 years after implant. We need new and better ways of identifying people who are at     high risk of sudden cardiac death so that we can prevent their deaths with ICDs. Our     understanding of the electrical signals in the heart has increased considerably in recent     years; in no small part this is due to our Principal Investigator Professor Andre Ng's basic     science work. This study aims to take the understanding of action potential duration (APD)     restitution gained through our work and other studies in humans and in computer simulations     and translate it into a fresh way of assessing risk of sudden cardiac death.      This study will carefully examine electrical activity, using APD restitution, in the hearts     of patients who are having ICDs fitted because of their high risk of sudden cardiac death and     combine this with a detailed heart scan, assessment of autonomic nervous system and gene     expression data. We will then follow these patients up to see who benefits from their ICD.     This wide ranging information will give us as complete a picture as possible of the factors     that cause sudden cardiac death. We hope to use this to identify better predictors of sudden     cardiac death.      The study hypotheses are as follows:      Primary        1. Regional Restitution Instability Index (R2I2) will be significantly higher in patients          reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.        2. An R2I2 cut-off of 1.03 will partition patients into high and low risk groups.           Secondary        3. Peri-infarct zone mass in grams will be significantly higher in patients reaching the          endpoint of ventricular endpoint / sudden cardiac death than in those not.   "
102499|NCT01944501|"     This study aimed at trying transcranial magnetic stimulation and transcranial direct current     stimulation as potential treatments to decrease tinnitus in patients with significant hearing     loss.   "
102500|NCT01944488|"     The project aims to establish the normal LH and FSH response to a standardized GnRH dose in     healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH     response in girls with early puberty development.      The novel data may help to determine whether the girl is in early puberty or not.      Healthy girls under 6 years of age attending routine examinations including an i.v. line for     other causes are included in this study. Our examinations also include bone age     determination, Tanner stage determination, and anthropometric measures (height and weight).     10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36     months, 36-48 months, 48-60 months and 60-72 months are included.   "
102529|NCT01944111|"     Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable     gastric banding in prospective clinical trial.   "
120840|NCT01704209|"     The purpose of this study is to find out if autologous (your own) fibroblast injections are     effective for the treatment of acne scars and wrinkles.   "
102502|NCT01944462|"     The overall goals of this program are to measure the impact of a pharmacist pneumococcal     vaccine education program (PPVP) using a senior center model of care and provide the     pneumococcal vaccine to eligible participants.      Hypotheses        1. PPVP will result in improved knowledge and awareness in older minorities in the senior          center setting (primary hypothesis);        2. Participants who are vaccinated through the project will experienced increased trust in          receiving vaccines from a pharmacist;        3. Participants will be satisfied with and trust the PV information provided by pharmacists          in the PPVP;        4. PPVP is an efficient approach to educating patients in the senior center based on its          costs;        5. Participating pharmacists will be activated to implement PPVP learnings in their          practice.   "
102503|NCT01944449|"     The objectives of this study are to examine the effects of chronic, (12 weeks) administration     of Whey protein on HbA1c, and postprandial glucose (PPG).   "
102504|NCT01944436|"     Lewy body spectrum disorders are a common group of neurodegenerative diseases that cause     memory loss, behavioural and motor disabilities that impair quality of life. Cognitive     enhancers help people afflicted with these conditions. However, some people do not benefit     from this treatment, while others experience serious side effects. Side effects and poor     response lead to hospitalization and early institutionalization. Pharmacogenomics, the study     of how DNA variation can influence drug effects, will be combined with functional changes in     brain imaging in response to cognitive enhancers in patients with Lewy body disease. The goal     is to develop a predictive test that can be administered in the clinic to aid physicians'     choice of initial medication. This can reduce health care costs and improve treatment to     Canadians suffering from these devastating disorders.   "
102505|NCT01944423|"     The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting     treatment of smoking cessation for individuals with panic attacks. The investigators     hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence     greater smoking abstinence rates and decreased panic symptoms after receiving a combined     CBT-based treatment for smokers with panic attacks.   "
102506|NCT01944410|"     The traumatic bone cyst (TBC) is an infrequent nonepithelial lined cavity of the jaws, which     was first expressed by lucassin 1929, the lesion has attracted a great deal of interest in     the dental literature, but its pathogenesis is still not evidently recognized. It determines     a bone cavity of irregular shape which appears like a cyst on a radiograph, and     histopathologically there are no elements to confirm a diagnosis of a cysts. TBC the     international histological classification assumed by the World Health Organisation for     odontogenic tumours utilizes the term solitary bone cyst, nevertheless the term traumatic     bone cyst (TBC) is more extensively used in the literature. The WHO classification explains     TBC as a non-neoplastic osseous lesion because it demonstrates no epithelial lining, which     differentiates this lesion from the true cysts. There is general conformity that most     traumatic bone cysts present without symptoms or signs. Seldom, expansion of the cortical     plate may occur with extraoral swelling, less commonly there may erosion through the cortical     bone may take place.' Teeth in the area of involved bone usually remain vital, without root     resorption or tooth mobility. Treatment of traumatic bone cysts has included surgical     exploration and curettage to motivate bleeding within the bony cavity,' packing of the cyst     cavity with Gelfoam which has been saturated with thrombin and penicillin, and bone grafting     based on previous study Injection of autogeneic blood into the bony cavity of a traumatic     bone cyst was followed by rapid resolution of the lesion.      Platelet-rich plasma (PRP) is a rich source of growth factors. The growth factors present in     PRP are familiar, including transforming growth factor-_ (TGF-_1 and TGF-_2), vascular     endothelial growth factor, 3 isomers of platelet-derived growth factor (PDGF-__,PDGF-__, and     PDGF-__), and endothelial growth factor. These growth factors are considered to have the     capacity to accelerate chemotaxis, mitogenesis, angiogenesis, and synthesis of collagen     matrix and support tissue repair when applied on bone wounds. Due to this high platelet     content, PRP has been used in orthopaedic surgery, oral implantology, and periodontics with     the aim of making the repair process as fast and natural as possible, as it can potentially     afford considerable tissue improvement in bone and soft tissue in a similar way. PRP is     easily acquired, rich in cell signalling molecules, completely autogenous and can be obtained     from minimal blood volumes.the purpose of the present study is to determine the efficacy of     PRP in the treatment of mandibular TBC.   "
102507|NCT01944397|"     We aim to investigate the prognosis of patients diagnosed with AF, particularly in relation     to the development of subsequent stroke, heart failure, and myocardial infarction. We will     explore the relationship between these outcomes and a range of risk factors.   "
102508|NCT01944384|"     Aim of study: The effects of aldosterone blockade on myocardial remodeling in hypertensive     patients with diastolic failing heart remains unclarified.      Background: Nearly half of patients with clinical heart failure (HF) have normal left     ventricular ejection fraction (LVEF) who usually present with apparent diastolic dysfunction     (DD) and are referred as diastolic HF (DHF). The renin-angiotensin-aldosterone system is an     established major pathway that is operative in the pathogenesis of HF. The effects of     aldosterone on myocardial hypertrophy, fibrosis and endothelial dysfunction have clearly been     established in human and animal models. Furthermore, in these models, aldosterone antagonism     prevented the development of myocardial fibrosis independent of its effect on blood pressure     or myocardial hypertrophy. However, its application to patients with DHF is unspecified. In     the study, we hypothesize that aldosterone blockade could reverse LV remodeling process in     hypertensive patients with DHF.      Study protocol: We will enroll medically well-controlled hypertensive patients who have DHF     defined as the presence of exertional dyspnea or HF signs/symptoms, diastolic dysfunction as     impaired tissue-Doppler (TDI) derived mitral early annular diastolic velocity (< 8 cm/s), and     LVEF > 50 % in echocardiography. All patients will be randomized to receive spironolactone 25     mg per day or not for at least 6 months. At baseline before randomization and 6 months after     randomization, we will investigate the Quality-of-life (QOL) score by Minnesota Living with     Heart Failure questionnaire (Chinese version), echocardiography coupled with TDI to assess     the degree of LV hypertrophy, myocardial systolic and diastolic characteristics. Otherwise,     we draw blood sampling at baseline and after randomization for quantifying and comparing     several biomarkers which are currently proved to be correlated with LV hypertrophy,     myocardial fibrosis, and biomechanical stretch in DHF patients, such as N-terminal     pro-brain-type natriuretic peptide, matrix metalloproteinase-2, carboxy-terminal telopeptide,     procollagen type III amino-terminal propeptide, soluble ST2, and galectin-3. Expected     results: Aldosterone antagonism is effective for hypertensive patients with DHF by improving     the quality of life, echo-derived myocardial function, and reducing ventricular mechanical     stretch through lessening the degree of LV hypertrophy and myocardial fibrosis.   "
102509|NCT01944371|"     The purpose of this study is to determine the safety, pharmacology and bioactivity of     disulfiram in antiretroviral treated HIV-infected adults. The investigators primary     hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in     CD4+ T-cells in patients on suppressive antiretroviral therapy (ART).   "
102530|NCT01944098|"     The primary objective is to assess the feasibility and safety of administering continuous     intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y     Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration     versus placebo (dextrose administration) (initiated at the time of anesthesia induction and     continued until extubation) will reduce postoperative narcotic requirements.   "
102672|NCT01942252|"     The purpose of this study was to determine whether high carboxyhemoglobin level is a risk     factor for postoperative adverse events in children exposured to carbon monoxide, especially     enviromental tobacco smoke.   "
122855|NCT01677897|"     The purpose of this study is to assess the impact of the addition of metformin to abiraterone     on survival in patients with metastatic prostate cancer   "
102510|NCT01944358|"     Syphilis and HIV are prone to occur concomitantly and the two diseases share several modes of     acquisition and risk factors such as men who have sex with men (MSM), sexual workers,     intravenous drug users, previous history of sexual transmitted diseases (STDs), and multiple     partners. HIV infection rates of up to 50% have been reported among patients diagnosed with     syphilis in several regions, with higher HIV infection rates among MSM. Besides, syphilis     ulcers are proposed to enhance the transmission of HIV. In Taiwan, there is also an     increasing prevalence of syphilis and HIV co-infection among MSM. Therefore, to treat     syphilis is an important issue for public health.      According to literature review, whether patients with HIV and syphilis co-infection had     higher serologic failure rate remains controversial, especially in the era after highly     active anti-retroviral therapy (HAART) was introduced since 1996. Ghanem et al recently     demonstrated that the use of HAART may reduce syphilis failure rates among HIV-infected     patients who have syphilis. In addition, the treatment guideline in 2006 suggested that the     treatment of primary syphilis and secondary syphilis is single dose benzathine penicillin G     regardless of HIV status; however, it goes on to suggest that some specialists recommended     additional treatments for HIV-infected patients, namely 3 doses, each a week apart. There is     no reference and evidence of strength of the suggestion but only specialists' opinion.      In the study, we aim to compare serologic response of syphilis to penicillin treatment     between HIV-infected and HIV-uninfected patients and to compare serologic response of early     syphilis (primary or secondary) to 1 dose and 3 doses of benzathine penicillin G among     HIV-infected patients. A longitudinal follow-up of serologic response will be conducted after     syphilis treatment.   "
102511|NCT01944345|"     The registry has been designed as a prospective, observational program for patients     undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in     the development of strategic treatment pathways and improved patient care. All patients who     agree to participate in the registry will sign an informed consent form and subsequently be     treated by their surgeon with the VariLift device. Potential treatment procedures include     bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar     interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar     spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be     performed in either an inpatient or outpatient facility. It is anticipated that the VariLift     devices will improve patient outcomes and lead to the development of treatment pathways to     improve patient care.   "
102512|NCT01944332|"     In this proposed research study, the investigators plan to assess the efficacy of gametes'     (egg and sperm) treatment on fertilization as well as pre- and post-implantation embryo     development.   "
102513|NCT01944319|"     To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a     population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract     infection patients.   "
102514|NCT01944306|"     Contraceptive failure is the primary cause of unintended pregnancy in the United States. With     obesity rates at epidemic proportions, any association between obesity and strategies that     prevent undesired pregnancies constitutes a significant public health and economic concern.     Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels     of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral     contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese     women, defined by their own birth weight, are at higher risk of contraceptive failure.     Further studies are necessary to investigate whether birth weight, a surrogate marker of in     utero growth restriction, is a useful diagnostic marker for the identification of women prone     to contraceptive failure. Such an understanding is critical to finding a contraceptive     strategy with better efficacy for these women.      The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in     obese women with low birth weight and compare to obese women with normal birth weight. The     main hypothesis for this proposal is that an adverse in utero environment programs the     expression and function of enzymes and transporters that underlie pharmacokinetics of oral     contraceptives, and leads to contraceptive failure.      Reproductive-aged, ovulatory women of obese BMI >30 kg/m2 with normal birth weight (5.5-8     lbs; n=10) and low birth weight (<5.5 lbs; n=10), will be placed on oral contraceptives for 1     month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins     (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol,     progesterone) will be monitored.   "
102515|NCT01944293|"     This study is designed to compare the effectiveness of two medications, Ketamine and     Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar     depression.      The first drug, ketamine, is an experimental antidepressant that early studies have shown may     quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the     comparison drug, is not thought to reduce depression or suicidal thoughts.   "
102516|NCT01944280|"     Primary Aim. The primary aim is to determine the effectiveness of intradialytic massage on     the frequency and severity of cramping among hemodialysis patients prone to lower extremity     cramping during treatment.      Hypothesis: Compared to control patients, intervention patients will be significantly less     likely to have intradialytic cramping that requires staff intervention or treatment     termination.      This is a study involving 32 (16 intervention, 16 control) hemodialysis patients with     frequent lower extremity cramps during treatment. Frequent cramping during dialysis     treatments is defined as 1 or more episodes of lower extremity cramps during or after     dialysis over the previous 2 weeks. Cramping frequency will be determined by chart notes.     Muscle cramping is defined as contraction of the large muscle group of the lower extremities     sufficiently painful to require intervention by the dialysis staff for relief.      The intervention group will receive a 20 minute massage of the lower extremities by a trained     and licensed massage therapist during each treatment (3x per week) for 2 weeks. The control     group will receive usual care by dialysis center staff.   "
102517|NCT01944267|"     This research study is looking at three different procedures for improving the oral mucosa     (membrane) around dental implants. The three procedures will be the standard procedure, the     standard procedure with the use of tissue harvested from the mouth and the standard procedure     with the use of Mucograft membrane product. An advantage claimed by the Mucograft     manufacturer is increased patient comfort due to lack of tissue harvesting from the mouth.     Pain and discomfort levels will be evaluated for each of the procedures. Gain in oral mucosa     and the visual will also be evaluated.   "
102518|NCT01944254|"     The intention of this study is to determine whether the precision of the measure of cardiac     output can be optimized by conducting the measurement while the participant is instructed to     exhale slowly. This will be compared to measurements done at random to respiration and timed     with the participant's spontaneous expiration.   "
102550|NCT01943838|"     Primary Objective:      - To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once     daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.   "
102519|NCT01944241|"     Over the last 20 years, cervical screening programs have had huge success in reducing     cervical cancer rates. These programs have done this by screening women at risk of developing     cancer with regular smear tests. Women with abnormal smears are followed up in colposcopy     clinics, and where needed, cervical surgery is performed to remove pre-cancerous areas on the     cervix.      Surgery to the cervix can include LLETZ (Large loop excision of the transformation zone)     treatment or cone biopsy. Many studies in the last few years have looked at the impact that     this necessary surgery can have on the function of the cervix. These studies have mainly     found an association between LLETZ treatment and an increased risk of preterm labour. There     have been no large studies investigating the effect cervical surgery may have on fertility.      The investigators would like to examine the impact that cervical surgery may have on a     woman's future fertility. It has been postulated that cervical surgery may cause the cervix     to close, preventing sperm getting through or that it may cause changes in the secretions of     the cervix, secretions that are necessary for normal interaction with sperm.      The investigators would like to send a questionnaire to women who have attended colposcopy.     The investigators will ask these women a series of questions relating to fertility desires     and divide the women in to two groups depending on whether the women needed cervical surgery     for pre-cancerous lesions or not.      Hypothesis: That cervical surgery has an impact on the function of the cervix and on     fertility.   "
102520|NCT01944228|"     The purpose of this study is to assess the effect of transvenous vagus nerve stimulation     (tVNS) on the immune response.      In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide     [LPS]) elicits a systemic immune response with release of pro-inflammatory cytokines, such as     TNF α. This trial will determine if an anti-inflammatory effect can be produced by acute VNS     using a minimally invasive delivery method.   "
102521|NCT01944215|"     The primary objective of this study is to determine if exercise, fasting, or eating prior to     the molecular breast imaging study will have an effect on the uptake of the tracer in the     breast tissue.   "
102522|NCT01944202|"     It is well documented that the proportion of inappropriate transthoracic echocardiograms     (TTEs) is highest in the ambulatory environment, where it has been reported as high as 30%.     Therefore, the potential to improve TTE utilization may be greatest in the outpatient     setting. However, no study to date has evaluated whether an Appropriate Use Criteria     (AUC)-based educational intervention can reduce inappropriate TTEs in this setting. The     investigators therefore designed the first randomized control trial of an AUC-based     educational and feedback intervention aimed at reducing inappropriate outpatient TTEs ordered     by cardiology and internal medicine physicians in training.   "
102523|NCT01944189|"     Despite preventive programs, effective case management is still the cornerstone in malaria     control.      This study is as a strategy towards improved recommendations in resource limited countries     during artemether -lumefantrine (AL) treatment in order to maximize the public health     benefits.      This is observational population pharmacokinetics study with a nested comparative     bioavailability study.The study is intended to describe the variability in lumefantrine blood     levels among under five year old Ugandan children with uncomplicated falciparum malaria     receiving current standard artemether-lumefantrine dose regimens. Findings will form a basis     for development of rational dosage recommendations. The nested comparative bioavailability     study will explore effect of profiled local food intake (maize porridge plus vegetable oil     versus milk) on lumefantrine uptake. As a strategy towards improved recommendations in     resource limited countries during AL treatment in order to maximize the public health     benefits. As a secondary objective we will correlate the variability in lumefantrine uptake     to malaria treatment outcome and safety profile in this population.      Research hypotheses        1. The population pharmacokinetic profile of lumefantrine among under five year old          children in Uganda with uncomplicated falciparum malaria is not affected by demographic          factors.        2. There is no difference in the bioavailability of lumefantrine when          artemether-lumefantrine is received with maize porridge plus vegetable oil versus milk          among under five year old Ugandan children treated for uncomplicated falciparum malaria.   "
102524|NCT01944176|"     Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is     steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as     atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that     statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD     patients.   "
102525|NCT01944163|"     Rationale: Axial spondyloarthritis (axSpA) is an inflammatory back pain disorder affecting up     to 24% of young chronic low back pain (CLBP) patients. For general practitioners (GPs) it is     difficult to distinguish axSpA patients in the large amount of CLBP patients. In previous     studies a referral rule for axSpA applicable in CLBP patients was developed and validated.     The next step is to investigate the impact of the referral rule in daily practice. This     impact analysis will test if the referral rule will be beneficial or harmful.      Objective: To evaluate the clinical impact of a referral rule in young patients presenting at     the general practitioners with chronic low back pain, who are at risk for axSpA, compared to     usual care.      Study design: A cluster randomized clinical trial. Study population: Primary care patients     with chronic low back pain, aged 18-45 years.      Intervention (if applicable): GPs are randomized in clusters either to use directly the     referral rule or use the referral rule after 4 months. The referral rule consists out of four     variables, a positive ASAS inflammatory back pain questionnaire, a positive family history     for spondyloarthritis, a good reaction to NSAIDs (non-steroidal anti-inflammatory drugs) and     back pain duration longer than 5 years. If at least two out of four variables are present a     referral to the rheumatologist is advised.      Main study parameters/endpoints: The primary outcome is a change in the Roland Morris     Disability Questionnaire (RMDQ) compared to baseline in the CLBP patients with or without use     of the referral model.      Secondary parameters: Quality of life measurements, cost-effectiveness, pain and fatigue and     referral to rheumatologist and diagnosis of axSpA.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      The burden and risks associated with participation are minimal. No medical intervention is     taken place. If the GP of the patients is randomized to the referral model, the patient is     checked for the risk of axial spondyloarthritis, by the non-invasive referral model. If the     referral model is positive a referral to the rheumatologist is advised. Is the GP is     randomized to the 'usual care' there is no difference in the treatment of low back pain than     nowadays. A GP is still allowed to treat the CLBP patients optimal and a referral to the     rheumatologist is allowed but not actively advised.      All participating CLBP patients are asked to fill several questionnaires at four different     time points, at baseline, after 12 months and after 24 months. In total there are 8     questionnaires and four separate questions. The questionnaire are designed to fill out by the     patient themselves. The total time to fill in the questionnaire is estimated to be 30     minutes.      The benefits of the study are:        -  For the CLBP patients, up to 24% of the back pain complaints are caused by axSpA, but          the GPs are not (yet) aware of this disease. When a CLBP patient is participating in          this study, the chance of having axSpA as cause for the back pain is investigated. This          a benefit for a CLBP patients since there is effective treatment for axSpA.        -  For the GP it is very difficult to distinguish an axSpA patients in the large amount of          CLBP patients. If it appears that the validated referral rule has an impact on CLBP and          GPs, the next step will be implementation of this referral model in daily practice and          it will become a helpful tool for the GP.        -  For the society, CLBP is a great socioeconomic burden for the society. When one of the          causes for CLBP, namely axSpA is diagnosed and treated in an earlier stage this will          lead to a decreased sick leave because of back pain and is therefore potentially          cost-effective.   "
102526|NCT01944150|"     At Saint-Antoine's hospital, in CETD a multidisciplinary team takes care of patients with     chronic pain. Free-drug techniques are available to reduce their consumption of analgesics.     This study is to assess the relief obtained by the simultaneous combination of these two     techniques: transcutaneous electrical nerve stimulation and hypnosis.   "
102527|NCT01944137|"     The main purpose of this study is to examine changes in patient-reported symptoms during the     first two cycles of neoadjuvant or adjuvant chemotherapy for non-small cell lung cancer     (NSCLC), colorectal cancer (CRC) and breast cancer, among patients who receive standard care     plus a proactive nursing intervention relative to patients who receive standard care alone.     Interventions to improve symptom management and prevent urgent care needs in both the clinic     and hospital for patients receiving chemotherapy with curative intent are needed to enhance     the quality of cancer care.   "
102528|NCT01944124|"     Cardiovascular diseases are the leading cause of death among Canadians. In those with     diabetes, cardiovascular complications are responsible for more than 70% of deaths. While     there is much interest in identifying and treating risk factors, the exact biological     mechanisms, their measurement and optimal ways to prevent and manage them are poorly     understood.      Physical activity and regular exercise can prevent diabetes and effectively manage risk     factors, but most Canadians do not exercise enough to beneficially manage risk. Tailored     exercise prescribed by a family physician has shown promise as a means to increase fitness     and reduce risk, but optimal implementation practices remain unknown - especially in rural     and remote communities with reduced access to healthcare. Mobile health technologies have     proved to be a beneficial tool to achieve blood pressure and blood glucose control in     patients with diabetes. These technologies may address the limited access to health     interventions in rural and remote regions. However, the potential as a tool to support     exercise-based prevention activities unknown.      Therefore, this study was undertaken to investigate the effects of a tailored exercise     prescription alone or supported by mobile health technologies to improve cardiovascular risk     factors in rural community-dwelling adults at risk for cardiovascular disease and type 2     diabetes.      Adults with cardiovascular risk factors were recruited from rural communities and randomized     to either: 1) an intervention group receiving an exercise prescription and devices for     monitoring of risk factors with a smartphone data portal equipped with a mobile health     application; or 2) an active control group receiving only an exercise prescription.      It was hypothesized that the intervention group would reduce their risk to a greater extent     than the active control group following 12 weeks, and that these improvements would be better     maintained in the intervention group at 24 and 52 weeks compared to the active control group.   "
102531|NCT01944085|"     This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the     pain score and pulse rate of children who undergo removal of percutaneous pins in the     outpatient clinic.      Inclusion criteria:        -  5-12 years of age        -  2 or 3 percutaneous pins in either elbow      Exclusion criteria:      - documented or suspected allergies to acetaminophen, ibuprofen      Patients enrolled in the study are instructed not take additional analgesia prior to the     clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the     trial.      At the clinic visit, they are randomized into one of three groups      1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).      They are served the `medication' (weight-appropriate dose) and the pins are removed in the     clinic an hour later.      Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately     following pin removal, and 10 minutes after pin removal.      The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do     not decrease pain score and pulse rate associated with the pin removal procedure.   "
102532|NCT01944072|"     Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group     design studied the effect of two aerobic exercise-training intensities in COPD     patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified     from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training     intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were     assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index,     London Chest activity of daily living scale, 6-minute walk, constant load and incremental     exercise tests. Patient's allocation sequence was computer-generated, with consignment in a     safe deposit box.   "
102533|NCT01944059|"     The purpose of this study is to evaluate the efficacy of Theramine® as a preventative for     migraine headaches.   "
102534|NCT01944046|"     The purpose of this research study is to learn about the effects of intranasal oxytocin as a     supplemental treatment for improving social difficulties in children and adolescents with     autism. This study will also provide additional information about the safety and tolerability     of intranasal oxytocin. Investigators expect oxytocin will increase social motivation,     improving daily living skills and quality of life.   "
102535|NCT01944033|"     The effectiveness of β2-agonists in the treatment of exacerbations of COPD is already     established. The purpose of this study is to compare the effectiveness of the β2-agonists     alone in nebulization with the association β2-agonists + Ipratropium bromide in the treatment     of an acute exacerbation of COPD consulting the emergency departement based on the clinical     and the aarterial blood gas.   "
102536|NCT01944020|"     Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete     loss of airflow during sleep, due to narrowing or closure of the upper airway. The resulting     hypoxia has many cardiometabolic consequences, and leads to a disruption of sleep quality     including reductions in the expression of rapid eye movement (REM) sleep and slow wave sleep     (SWS). Patients also frequently experience excessive daytime sleepiness (EDS), which, when     present with OSA, defines the clinical entity OSA syndrome (OSAS). Obesity is the leading     risk factor for the development of OSA. Interestingly, it has been suggested that the     disorder itself may contribute to further weight gain, presenting a vicious cycle wherein OSA     and obesity perpetuate each other. OSAS may promote weight gain by placing patients in a     state of positive energy balance characterized by low levels of physical activity and     disrupted patterns of appetite-regulating hormones. Continuous positive airway pressure     (CPAP), the gold-standard treatment of OSAS, may improve energy balance in these patients,     although this has not yet been adequately studied. The current proposal will investigate the     effects of 2 months of CPAP on energy balance and cardiovascular risk in obese patients with     moderate-to-severe OSA and EDS. Patients will be instructed to use CPAP at home each night     throughout the 2-month treatment phases. At baseline and at the conclusion of the 2-month     treatment phase, the investigators will measure levels of free-living physical activity,     sleepiness, sleep quality, body composition, cardiovascular risk factors, appetite-regulating     hormones, hunger, and ad libitum food intake. It is hypothesized that active compared to sham     CPAP treatment will result in improvements in energy balance, including increased physical     activity, reductions in abnormally high levels of circulating leptin levels, and reductions     in hunger, food intake, and cardiovascular risk factors. These improvements are hypothesized     to be associated with increases in the expression of REM sleep and SWS, and reduced EDS as a     result of CPAP.   "
102537|NCT01944007|"     This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.   "
102538|NCT01943994|"     One of the most promising lines of investigation for the therapeutic use of hallucinogens in     the 1960s and 1970s was in the treatment of drug dependence. We propose to examine psilocybin     administration combined with a structured smoking cessation treatment program in nicotine     dependent individuals in order to provide preliminary data on the efficacy of this combined     treatment for smoking cessation. Prior work in our laboratory has shown that under carefully     prepared and supportive conditions, psilocybin administration can facilitate highly salient     experiences with enduring personal meaning and spiritual significance (Griffiths et al.,     2006, 2008). It is plausible that embedding such highly meaningful experiences into a drug     dependence cessation attempt may provide an enduring motivation for remaining abstinent.     Cigarette smoking is a good model system for studying drug dependence because users are less     likely to be challenged by the many social and economic impairments that often accompany     dependence on other drugs such as cocaine, heroin, or alcohol. More specifically, we propose     to conduct a randomized controlled comparative efficacy study in which either psilocybin or     transdermal nicotine patch are administered under highly supportive conditions to individuals     who are nicotine-dependent cigarette smokers, who have had multiple unsuccessful quit     attempts, and who continue to desire to quit smoking. Other than nicotine dependence,     participants will be healthy. Fifteen participants have already completed a preliminary     open-label pilot-study with no control condition. Fifty additional participants will be     enrolled and randomized to either psilocybin (n=25), or nicotine patch (n=25) treatment.     Participants will receive a 13-week course of cognitive behavioral therapy for smoking     cessation, with Target Quit Date set for week 5. After several preparation meetings with     study monitors, participants will have either a single day-long psilocybin session using a     high dose (30 mg/70 kg), or a standard 8 to 10-week course of nicotine patch treatment.     Participant smoking status will be assessed repeatedly for 8 weeks after the Target Quit     Date, including biological verification of smoking status through breath and urine samples.     Smoking status will also be assessed at three follow up sessions approximately 3, 6, and 12     months after the Target Quit Date. Additionally, participants will undergo MRI scanning     before and after Target Quit Date to assess the brain-based mechanisms associated with these     treatments. Individuals assigned to the nicotine patch study treatment condition will be     eligible to undergo an optional high dose psilocybin session after completing the 6-month     follow-up meeting.   "
102539|NCT01943981|"     Heart failure and stroke are the two major complication of atrial fibrillation. Current     treatment for atrial fibrillation is so focused to stroke prevention, but the risk assessment     for heart failure is less highlighted. The most of patients with atrial fibrillation have     cardiac functional limitation of variable degree. We hypothesize that the exercise test would     reveal the subclinical cardiac dysfunction, and might be helpful to classify the patients     with atrial fibrillation according to their exercise capacity real cardiac function.   "
102540|NCT01943968|"     The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic     sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and     lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic     sclerosis. The results obtained may help us diagnose these complications of systemic     sclerosis and hopefully even monitor patient treatment.   "
122856|NCT01677884|"     The purpose of the study is to assessed the efficiency of treatment based on the objective     response rate (RECIST 1.1)   "
102541|NCT01943955|"     It is hypothesized that a home-based computer gaming rehabilitation program will improve gaze     control and balance impairments in those with peripheral vestibular disorders (PVD). Ten     people with peripheral vestibular disorders were started on a treatment program that     consisted of playing computer games and while performing various balance exercises. On a     weekly basis, each participant was contacted by email or telephone and asked to submit their     computer gaming data to a trained vestibular physical therapist. Following review of this     data, the physical therapist would contact the participant and progress their computer gaming     program appropriately. At the completion of twelve weeks of home treatment, the participants     returned for re-assessment and it was determined that the computer gaming program was an     effective treatment for those with PVD. It was also determined that a monitored     telerehabilitation program was an efficient and effective delivery method for this treatment.   "
102542|NCT01943942|"     The objective of this study was to confirm if two formulations of montelukast tablets are     bioequivalent.      Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product Singulair     (10 mg tablets; Merck Sharp & Dohme). The single dosage was one tablet.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 32 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
102543|NCT01943929|"     Headache is the most common complaint to neurologists. In the 80´s and 90's few papers, with     limited number of patients, have proposed the association between nasal septum contact and     headache. The International Classification of Headaches Disorders proposed specific     diagnostic criteria for this entity.      With the major use of CT scans, the contact between nasal mucosa and septum is daily observed     in many patients without complaint of headache.      The purpose of this study is to determine if there is any correlation between nasal and     septum mucosa contact and the prevalence of headache. The investigators hypothesized that no     correlation will be found using CT scans in a large series of patients.   "
102544|NCT01943916|"     Imagio is a multi-modality device, comprised of opto-acoustic (OA) imaging co-registered with     diagnostic grey-scale (B mode) ultrasound, that has been designed to concurrently collect OA     images in conjunction with diagnostic grey-scale (B-mode) ultrasound.      Imagio is expected to identify two functional hallmarks of a potential malignancy: the     presence of abnormal blood vessels (angiogenesis); and the relative reduction in oxygen     content of hemoglobin. The technology is non-invasive and does not require any contrast agent     or radio-isotope, which is required for other modalities such as MRI or PET.      This is a prospective, single arm, controlled, multi-center, observational study that will     compare Imagio versus conventional diagnostic ultrasound (CDU) for the visualization of     suspicious masses.   "
102545|NCT01943903|"     The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization,     and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in     patients with suspected CAD in order to further inform patients, health care providers, and     other stakeholders about which technologies are most effective and efficient in the diagnosis     of CAD   "
102546|NCT01943890|"     Background Nebulised hypertonic saline (HS) is an established basic airway clearance     treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical     implementation and administration of different HS volumes, including physiotherapy and     aspects of breathing pattern.      The aim of the study was to implement standardised and age-adjusted nebulised volumes of     hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage     techniques.   "
102547|NCT01943877|"     This study was conducted to evaluate by clinical and microbiological parameters the effect of     locally delivered propolis as an adjunct to scaling and root planing in the treatment of     chronic periodontitis.   "
102548|NCT01943864|"     This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and     safety of orally administered MEK inhibitor trametinib as the second line in subjects with     advanced or metastatic biliary tract cancers (BTC) in Japanese population. The primary     endpoint of this study is 12 week non-progressive disease (PD) rate defined as the percentage     of subjects without progression at Week 12. As a sub-study, pharmacokinetics (PK) of four     tablets of 0.5 milligram (mg) tablet, or one tablet of 2 mg tablet to achieve 2 mg daily     regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese     population.      Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose     of 2 mg every day as one 2 mg tablet or four 0.5 mg tablets on Day 1. From Day 2 until     disease progression or withdrawal from the study treatment, all subjects will receive one     tablet of 2 mg trametinib . Disease assessment will be performed every 8 week. Translational     research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers     for biological activity, and sensitivity or resistance to treatment with trametinib .   "
102549|NCT01943851|"     This is an open-label repeat dose, multicenter, 2-part study to determine the maximum     tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily     (QD) orally. Part 1 of the study is a dose escalation phase to select the recommended Part 2     dose (RP2D) based on the safety, PK, and PD profiles observed after oral administration of     GSK525762. Eligible subjects with select relapsed refractory hematological malignancies     (acute myeloid leukemia [AML], non-Hodgkin's Lymphoma [NHL]and multiple myeloma [MM]), will     be enrolled in the QD and/or BID dosing cohorts until a MTD is established. Subjects may     continue treatment in the study until disease progression, unacceptable toxicity, or     withdrawal of consent. . Upon determination of the MTD, twice daily (BID) dosing cohorts may     be opened to collect additional safety data and evaluate the preliminary efficacy of     GSK525762 administered BID. Part 2 will explore clinical activity at the MTD or RP2D;     separate expansion cohorts will be planned for acute myeloid leukemia (AML), non-Hodgkin's     Lymphoma (NHL, including an exploratory sub-cohort of subjects with myc and B-Cell Leukemia     (BCL)2 and/or BCL6 rearrangements/overexpression [double- and triple-hit lymphoma]), and     multiple myeloma (MM). This is the first study of this agent to be conducted in subjects with     these relapsed and/or refractory hematological malignancies for which no standard therapies     are anticipated to result in a durable remission.   "
102551|NCT01943825|"     The aim of the study is to evaluate a compressed dosing schedule and the immunologic effects     of co-administration of a flavivirus with JE vaccine.      Primary Objectives:        -  To describe and compare the humoral immune response to each of the 4 parental dengue          virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.        -  To describe the persistence of the humoral immune response to each of the 4 parental          dengue virus serotypes 6 months after CYD dengue vaccine Dose 3, irrespective of whether          or not JE vaccine has been previously administered.      Secondary Objectives:        -  To describe the safety profile after each injection of CYD dengue vaccine.        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes          at baseline and 28 days after each CYD dengue vaccine dose when administered with or          after JE virus vaccine.        -  To describe the persistence of the humoral immune response to each of the 4 parental          dengue virus serotypes at six months post-Dose 3 in all four groups and at 12 months          post dose 3 in Groups 1 and 3 with the compressed schedule.        -  To describe the JE humoral immune response 28 days after each injection of CYD dengue          vaccine.   "
102552|NCT01943812|"     The aim of this study is to compare two FET protocols by modifying the substituted FET cycle     in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early     pregnancy loss.      Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early     pregnancy loss.   "
102553|NCT01943799|"     This study will evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis     B (CHB) viral infection who have been virally suppressed with an oral antiviral medication.     Participants will be randomized in a 1:2:2:2 ratio to the treatment arms for 20 weeks.   "
102554|NCT01943786|"     Adenocarcinoma of the colon and rectum is a common, serious disease and it is the second     cause of death from cancer in Spain.      The prognosis of CRC depends to a great extent on its stage when diagnosed. Patients with     advanced disease, who present up to 40% of all patients, have a poor prognosis. Although the     application of modern chemotherapy and radiotherapy treatments obtains median survival     periods of around 24 months, the proportion of patients with advanced disease who obtain a     cure is low.      Systemic treatment of advanced CRC has changed considerably in the last ten years with the     introduction of active drugs such as oxaliplatin, irinotecan, and capecitabine. The most     commonly used first line regimens are 5-Fluorouracil-Leucovorin-Oxaliplatin (FOLFOX),     Capecitabine-Oxaliplatin (XELOX), 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) and, to a     lesser extent, Capecitabine-Irinotecan (XELIRI). Chemotherapy regimens are combined with     different agents against therapeutic targets, three of which are effective in colon cancer:     bevacizumab, which targets vascular endothelial growth factor (VEGF) and cetuximab or     panitumumab, which target the epidermal growth factor receptor (EGFR).      The use of cetuximab and panitumumab is not recommended in patients with KRAS mutations and     the combination of a VEGF and EGFR agents is not beneficial.      Two recent studies results have identified KRAS mutations as frequent drivers of acquired     resistance to cetuximab and panitumumab in colorectal cancer patients. The conclusions     indicate that the emergence of KRAS mutant clones can be detected non-invasively months     before radiographic progression by a DNA Blood Test (Inostics´BEAMing Technology).      Centro Integral Oncológico Clara Campal (CIOCC) is aiming to undertake a pioneer project     aimed at integrating the analysis of KRAS switch status by BEAMing Technology in patients     with metastatic colorectal cancer, tumor KRAS wild-type and BEAMing wild-type treated with     first line FOLFIRI-cetuximab      In naive chemotherapy tumor-KRAS wild-type metastatic colorectal cancer patients, who are     BEAMing positive (KRAS mutated in blood) before treatment may have worse evolution in terms     of PFS (progression Free Survival) and response rate than BEAMing negative (KRAS native in     blood) patients.      To know the proportion of patients who are BEAMing positive (KRAS mutation can be detected in     circulating extracellular DNA) at the beginning of treatment, could be of great importance     for treatment efficacy.   "
102555|NCT01943773|"     Purpose: To compare post-operative functional outcomes in patients undergoing preoperative     functional prehabilitation versus standard of care preoperative management in older adults     undergoing major elective operations.      Hypothesis: Older adults undergoing preoperative functional prehabilitation (nine sessions of     home physical therapy over three weeks) will have improved physical function and reduced     delirium in comparison to usual preoperative care following major abdominal and thoracic     operations.      Specific Aims:      (#1) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de     Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical     performance battery scores in the control and intervention groups at the preoperative and     initial assessment timepoints.      (#2) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de     Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical     performance battery scores in the control and intervention groups at the 60-days     postoperative and the initial assessment timepoints.      (#3)To compare the rates of ICU delirium and need for post-discharge institutionalization in     patients in the control and interventions groups.      (#4) To compare post-operative complications   "
102556|NCT01943760|"     Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute     pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the     possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and     vomiting make the tramadol infiltration a technique of interest. There is controversy about     its effectiveness.      The local effect of tramadol in hernioplasty was also studied by researchers with some better     postoperative analgesia than with local anestetic .      There are few studies with administration of tramadol for hernioplasty, Which led to the     interest in this study.   "
102557|NCT01943747|"     To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World     Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an     international point prevalence study of severe sepsis and septic shock. The goal of this     project is to determine the world wide burden of severe sepsis and define current practices     of sepsis care internationally. The study is a simple data collection exercise for patients     presenting with either severe sepsis or septic shock on World Sepsis Day.   "
102558|NCT01943734|"     Objective: To verify the influence of information passed during anthropometric assessment     would have in physical exercise (PhE) and eating habits of 14 participants (female=11;     51,07+-8,17 years) from the Stretch Break Program of Federal University of Paraíba (SBP of     FUPb). Methods: The research was a descriptive cross-sectional quantitative and qualitative     approach. Were applied, between March and May of 2010, anthropometric evaluation and     semi-structured interviews. During the evaluation were provided information and guidance on     health.   "
102559|NCT01943721|"     The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.   "
102560|NCT01943708|"     This single-blind randomised crossover trial aims to compare the efficacy of a novel     Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an     OSA population, aged over 18.   "
102561|NCT01943695|"     The purpose of this study is to compare the effects of aerobic exercise training during and     after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.   "
102562|NCT01943682|"     The purpose of this study is to test the safety of a study drug called CPX-351. This drug has     been tested in adults but not yet in children and adolescents. This study tests different     doses of the drug to see which dose is safer in children and adolescents.      Patients who have blood cancer are being asked to take part in this study . Blood cancers may     include leukemia and lymphoma. Patients able to be in this study have already been treated     with standard chemotherapy for their disease and the disease is still growing or has come     back.      CPX-351 is a drug that is not yet approved by the United States Food and Drug Administration     (FDA) and is only used in research studies like this one. CPX-351 is made up of two     chemotherapy drugs that patients may have already received called cytarabine and daunorubicin     that are now packaged together.      Another purpose of this study is to collect blood samples for special research studies.     Researchers want to study how much of the CPX-351 is in the body over time. These studies are     call pharmacokinetic studies or PK studies for short. PK studies require the collection of     several blood samples before and after participants are given the study drug.   "
102563|NCT01943669|"     In this study, 10 volunteer participants with chronic spinal cord injury will undergo a     10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a     lightweight brace-support suit containing motors at the hip and knee joints, rechargeable     batteries and a computerized control system carried in a backpack. ReWalk™ users control     their ambulation through subtle changes in centre of gravity and upper-body movements.     Before, during and after training sessions the volunteers will perform standardised     assessments and complete questionnaires to assess the functional and psychological effects of     the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological     outcomes primarily focus on predisposition and perceptions of disability. The outcomes of     this pilot study will assist the investigators in the preparations of randomised controlled     trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.   "
102564|NCT01943656|"     As technologies are advancing quickly in the healthcare setting, new solutions have become     available helping disable people to enhance their ability to communicate. One of these     advances is the introduction of the 'eye gaze system'. Through processing eye movements, this     device allows a person to write, speak, use the Internet and even control systems in the home     or office. In the currently proposed study we aim to evaluate the psychological and     functional effects of using the Tobii™ Eyegaze System by inpatients with tetraplegia who are     unable to use arms and legs and sometimes are not able to talk because of an impaired     respiratory function.      Volunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers     will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions     required to successfully master the device depends on the learning curve of the patient. The     progress will be documented accordingly. After successful completion of the training and     supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised     use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™     Eyegaze System by inpatients with tetraplegia results in improved disability perception and     independence scores. For the current feasibility study 12 participants will be recruited and     assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and     'eyeskills' to instruct the computer system. Positive study outcomes will encourage future     studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home     environment.   "
102565|NCT01943643|"     This is prospective, observational study, that will be conducted in two high-volume     university interventional cardiology centers. Study population consists of patients with     true coronary bifurcations (Medina 1.0.1; 0.1.1; 1.1.1) with >50% stenosis in both main     (MB) and side branch (SB). Patients are scheduled to undergo percutaneous coronary     intervention (PCI) based on clinical findings. Before PCI, patients will undergo multislice     CT angiography (MSCTA). MSCTA before PCI for true non left main bifurcation lesions can     determine atherosclerotic plaque characteristics in MB and SB and predict significant     narrowing of SB after provisional stenting. Primary goal is to determine which plaque     characteristics of true non left main bifurcation lesions in MB and SB, as assessed by     MSCTA, can affect the occurrence of SB ostial compromise after provisional stenting. Patients     will be seen in the office visit at 1, 3, 6 and 12 months after the procedure. Clinical     evaluation and 12-channel ECG are mandatory at each visit. Comprehensive echocardiogram with     2D-strain analysis will be done at 3-month visit. Repeated coronary angiography will be done     at 6-month visit, and will include quantitative analysis of previously treated bifurcation     lesion.   "
102566|NCT01943630|"     The purpose of this double blind study is to determine whether topical 15% AS101 gel is     effective and safe as compared to vehicle in the treatment of external genital warts in     women.   "
102567|NCT01943617|"     Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver     cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the     other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year,     entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six     months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver     ultrasonography, and Fibroscan;   "
102580|NCT01943448|"     Visual impairment in high myopic eyes is mainly due to the different types of myopic     maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal     neovascularization. Macular hemorrhage was one of those complications. Despite choroidal     neovascularization, simple hemorrhage from rupture of Bruch's membrane and choroidal     microcirculation is also the cause of hemorrhage. The prognosis of those eyes with simple     hemorrhage is generally good. However, some patients had persistently poor vision after the     absorption of the hemorrhage. In the literature, the visual prognosis in those patients was     reported to be associated with the microstructure change under the optical coherent     tomography (OCT) or the presentation of the autofluorescence. The investigators will collect     the patients with high myopia and presenting with macular hemorrhage. High resolution OCT and     autofluorescence imaging will be used to analyze the change of the microstructure of retina     and its correlation with the visual prognosis.   "
102686|NCT01942070|"     The aim of the current study is to test the clinical performance of the everolimus-eluting     BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients     undergoing PCI in the setting of acute MI.   "
102568|NCT01943604|"     This study is designed to examine healthy children who skip breakfast and the effects of     fasting on their neuropsychological functioning and the potential benefits that a Balanced     Breakfast may have on their learning abilities. It is expected that this study will provide     new knowledge on how prolonged periods of 8 or more hours without food affect neurocognitive     processes and thus learning how specific meals following this period of fasting, which most     children experience, change those processes, potentially for the better.      The hypotheses for this study are:        1. Children who consume breakfast will demonstrate significantly higher levels of          attention, greater concentration, and diminished impulsivity compared to children who do          not consume breakfast.        2. Children who consume breakfast will demonstrate a significantly quicker reaction time          and increased accuracy in correctly identifying target stimuli from an array compared to          children who do not consume breakfast.        3. Children who consume breakfast will demonstrate increased freedom from distractibility          and enhanced short-term memory compared to children who do not consume breakfast.        4. Children who consume breakfast will demonstrate increased cognitive processing speed          compared to children who do not consume breakfast.        5. Children who consume breakfast will have improved verbal learning compared to children          who do not consume breakfast.        6. Children who consume breakfast will have improved visual memory compared to children who          do not consume breakfast.   "
102569|NCT01943591|"     Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of     intracranial aneurysms. Unfortunately, endovascular treatment of aneurysms with coils has     been associated with incomplete occlusion at initial treatment (remnant) or at follow-up     (recurrence). This in some studies has been as high as 20%. While many such aneurysm remnants     or recurrences exhibit benign behavior, many require retreatment to prevent future     hemorrhage.      A recent randomized controlled trial of aneurysm coiling revealed that aneurysms between 2     and 9.9 mm diameter were more likely to have an improved angiographic and composite clinical     outcome when treated with hydrogel-coated coils, an improvement inferred to result from     higher packing density afforded by hydrogel expansion(1). The use of hydrogel coils is     associated with technical difficulties related to expansion and limited time for deployment.     The investigators theorize that similar results could be achieved by using more voluminous     bare platinum coils, leading to improved packing density compared to smaller caliber coils,     and thus result in lower incidence of remnants or residuals. The relationship between packing     densities and composite clinical endpoints having never been shown in a robust fashion, the     investigators therefore propose a randomized clinical trial opposing coiling with soft     15-caliber coils to 10-caliber bare platinum coils in aneurysms varying in size from 3 to 9.9     mm.      To test the hypothesis that 15-caliber coiling systems are superior to standard 10-caliber     coils in achieving better composite outcomes, the investigators propose the DELTA trial: Does     Embolization with Larger coils lead to better Treatment of Aneurysms trial, a randomized     controlled blinded trial with 2 subgroups of 282 patients each, 564 total:      Subgroup 1: Coiled with a maximum proportion of 15-caliber coils as conditions allow Subgroup     2: Coiled with 10-caliber coils.   "
102570|NCT01943578|"     The study examines the physical capacity of lung cancer patients assessed with the six minute     walk test and handgrip strength. Demographic and selfreported exercise behavior is registered     to explore correlations to functional and physical capacity.      Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an     expected average of 12 weeks between first and second assessment.   "
102571|NCT01943565|"     Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain     medications called opioids, such as morphine, are given through the vein or into the muscle.     However, a more effective way to give pain relief with fewer side effects (such as nausea and     slowing your breathing) is to give opioids in the spinal space as part of the medications     given for a cesarean delivery.      For many years, the opioid of choice was morphine due to its long anesthetic effect and     acceptable side effect profile. A nation-wide disruption in the supply of preservative-free     morphine has made it necessary to look for alternatives. Many institutions worldwide have     used another opioid, called hydromorphone, in the spinal space for over a decade. This drug     has a very good safety and side effect profile and has been used at the investigators'     institution for more than a year. Of interest, while a number of different doses of     hydromorphone have been used, there have been very few studies to evaluate the best dose for     providing good pain relief with minimal side effects. The goal of this study is to find the     best dose of spinal hydromorphone for women undergoing cesarean delivery.   "
102572|NCT01943552|"     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre     trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese     peri-operative patients with COPD under general anaesthesia.   "
102573|NCT01943539|"     A study in ADHD and neuro-typical children to assess EVO game play over 29 days.   "
102575|NCT01943513|"     The primary objective of this study is to determine whether muscle atrophy induced by     immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The     secondary objectives of this study in this study population are:        -  To determine whether muscle weakness induced by immobilization of the lower limb can be          attenuated by BIIB023        -  To assess the effect of BIIB023 on the recovery of muscle mass and strength after          immobilization        -  To assess the effect of BIIB023 on histological markers of muscle atrophy and          regeneration        -  To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism          recovery kinetics        -  To evaluate the safety and tolerability of BIIB023   "
102576|NCT01943500|"     Objective: To test the sensitivity of a proprietary novel filtration device designed to     capture and concentrate circulating tumor cells (CTCs).   "
102577|NCT01943487|"     This study investigates the effect of the co-administration of verapamil on the steady-state     pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet,     EC905.   "
102578|NCT01943474|"     The study will test a hypothesis that the AccuCath™ System will have a higher rate of     successful first attempt peripheral intravenous (IV) placement, higher completion of therapy,     fewer complications, longer dwell times, and higher user satisfaction compared to     conventional IV catheters.   "
102579|NCT01943461|"     This is a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting     programmed death ligand 1 [anti PD-L1]) in Japanese subjects with metastatic or locally     advanced solid tumors, followed by a consecutive expansion part in Asian subjects with     gastric cancer.   "
102622|NCT01942902|"     The purpose of this study is to evaluate the system performance of the GlySure Continuous     Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.   "
102974|NCT01938287|"     This study investigates the effect of eye opening/closure on the quality of IOP (intraocular     pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2     24-hour recording sessions, one with the recorded eye open and the other with the eye     closed,using an ophthalmic patch.   "
102581|NCT01943435|"     BACKGROUND: Lumbar spinal stenosis - known by patients as arthritis of the spine - is a     condition that is very common; found in about 30% of older adults. It is the most common     reason for people over the age of 65 to have back surgery. Some patients with stenosis do not     need back surgery and can be treated with other methods, such as physical therapy,     chiropractic, exercise, and medication. But we just don't have enough good research to tell     us which treatment works best for which patient and under which circumstances. This research     study hopes to provide more information about the effectiveness of the various non-surgical     choices for managing stenosis.      OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical     treatment approaches for stenosis:        1. Usual medical care that involves prescription medications and/or spinal injections          (epidurals)        2. Group exercise in supervised classes given in a community center setting        3. Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by          physical therapists and chiropractors      METHODS: This research study will involve 180 adults who are at least 60 years old and have     been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into     three groups, each group receiving one of the 3 types of treatments listed above under     Objectives. The determination of which type of treatment each person receives will be     determined by chance, using a computerized version of flipping a coin. This is a process     known as randomization, which scientists think reduces the bias in research studies. A series     of tests and questionnaires will be given to the patients before and after they get treatment     and comparisons will be made to see how much improvement they made with each of the types of     treatments. Finally, the researchers will compare the differences between the 3 treatment     groups to see if certain types of treatment produced better results than others, and if there     were any examination findings that could be used to predict which type of patient would do     better with which type of treatment.   "
102582|NCT01943422|"     This is a dose-seeking and efficacy study of combined BRAF Inhibitor Vemurafenib and     High-dose Interferon alfa-2b for therapy of advanced melanoma.   "
102583|NCT01943409|"     Intravenous nutrition is an important therapy for the recovery of many patients. It is     indicated when the patients cannot take food by mouth or use their intestines for feeding. It     is important to indicate it in the appropriate setting because it's not free of complications     and is a costly treatment. Some of the complications are: elevated blood sugar or lipids,     elevated liver function tests, infection of the catheter or device used to administer     intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates     (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based     lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010,     a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for     use in intravenous nutrition. There is an increasing need for hospitals to evaluate the     quality of intravenous nutrition administered to hospitalized patients in terms of: assessing     indications, prescription, complications, clinical results and costs. The objective of this     study is to determine if intravenous nutrition prescribed in hospitalized patients is     indicated following existing guidelines in terms of timing of nutrition support,     prescription, monitoring and whether it is associated with complications. In addition, length     of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and     inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid)     compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).   "
102584|NCT01943396|"     In this research rheohemapheresis will be used for the treatment of patients with high-risk     dry form of age-related macular degeneration. Correction of rheologic parameters and     activation of retinal functional reserves after the therapy will positively influence     functional condition of retina. The newest special electrophysiologic methods will be used to     determine retinal changes in time. The investigators will also evaluate some important     immunologic factors and complement changes as well as define indication criteria more     precisely.   "
102585|NCT01943383|"     Patients enrolled in this study will have completed one of the parent studies     Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR-1 or PEAR-2) evaluating how     well their blood pressure was controlled by medication. Patients in the current study will     provide a single tube of blood which will be used to create adult stem cells that can be     converted into other cell types, like heart or vasculature. Patients will not be asked to     return for any follow up visits.   "
102586|NCT01943370|"     Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus     surgery. However, the ideal timing and quantity of irrigation in the early post-operative     period remains unknown. Proposed benefits of early, large volume irrigation include removal     and softening of crusts, resulting in improved mucociliary clearance. The potential benefit     of early large volume saline irrigation on post-operative day three to ease or reduce the     need for early post-operative debridement has not been studied.   "
102587|NCT01943357|"     The study will help determine if the Better Choices Better Health Diabetes program     (community-based or online, also known as the Diabetes Self-Management Program) improves the     hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms     (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy     behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot,     kidney and cholesterol exams; and activity), 3) the use of health care services. This project     is a translational study to demonstrate the effectiveness of the intervention in the context     of a major insurer.   "
102588|NCT01943344|"     The purpose of this Clinical Investigation is to gather feasibility data on the clinical use     of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to     percutaneously close femoral arterial puncture sites in the range of 18-24 F, post     endovascular procedures.   "
102589|NCT01943331|"     The current protocol desires to implement a large-multicenter observational study of hospital     acquired infection in ICU in China. The study will generate data on generate data about the     epidemiology current management of nosocomial infection.   "
102590|NCT01943318|"     Liver cirrhosis represents a worldwide health problem and is a major cause of mortality.     Cirrhosis is the common end for chronic alcohol abuse and hepatitis C and B virus infections.     Patients who have cirrhosis have varying degrees of compensated liver function, and     clinicians need to differentiate between those who have stable, compensated cirrhosis and     those who have decompensated cirrhosis. It is shown various complications: portal     hypertension, hepatocellular carcinoma, hepato-renal syndrome, etc.      Thus, it is important to have this information to manage disease and determine specific     therapy. However, register-based studies in have not been reported in Korea.      The goal of this study is to describe the natural history of a large number of patients with     liver cirrhosis prospectively followed, and to identify predictors of the occurrence of     Hepatocellular carcinoma.   "
102687|NCT01942057|"     The goal of this study is to determine the prevalence of nearsightedness in Canadian school     children living in the Waterloo Region.   "
102591|NCT01943305|"     Epidemic viral diseases have become more prevalent in recent years. Among the various     strategies to prevent such epidemics, vaccination is the most cost-effective. However,     populations that are immunized are typically already exposed to multiple previous     vaccinations or natural infections. Studies from this and other laboratories have revealed     that pre-existing dengue antibodies can either inhibit or enhance subsequent dengue infection     depending on the pre-existing antibody levels. While cross-reactive antibody is potentially     pathogenic in dengue, how it impacts immune response to vaccination is unclear. Indeed,     aggregated at the site of vaccination and the respective draining lymph nodes are     antigen-presenting and immune regulatory cells that express Fc receptors and play pivotal     roles in determining the magnitude and polarity of the immune response. Vaccine uptake by     these antigen-presenting cells may thus be either inhibited or enhanced when vaccines are     opsonized with cross-reactive antibodies.      In view of the limited knowledge on how cross-reactive antibodies affect vaccination outcome,     investigators propose here a study that exploits the known cross reactivity between Japanese     encephalitis (JE) virus antibody and yellow fever (YF) vaccine. Investigators hypothesize     that cross-reactive antibodies impacts antibody response to YF at the point vaccination in a     concentration-dependent manner by altering both vaccine uptake and the innate immune response     by antigen presenting cells. Investigators will structure an open label clinical trial on     sequential vaccination with JE and YF vaccines, with different time intervals between     vaccinations. This would test immune response to YF vaccination in subjects with different     titer of cross-reactive JE vaccine-derived antibodies.   "
102592|NCT01943292|"     This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal     adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies. The     purpose of this study is to assess the safety (including the recommended phase 2 dose), the     pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063).   "
102593|NCT01943279|"     Background: Medical abortions in Canada are provided using a standard regimen of methotrexate     and misoprostol. After these medications are administered, patients are most commonly checked     for termination of the pregnancy with an ultrasound and physical examination at an in-clinic     follow-up appointment. These follow-up appointments can be inconvenient, costly, and take     away from patient privacy. Furthermore, it has been suggested that these follow-up     appointments may not be necessary for patients.      Objective: To determine whether remote follow-up, using telephone and blood testing is a     feasible, safe, and effective method of follow‐up after medical abortion, compared to     standard care that requires an in-clinic visit and ultrasound.      This study offers women the option of remote follow-up by telephone combined with serum     Beta-human chorionic gonadotropin (β-hCG) testing or standard in-clinic follow up. We will     determine women's preferences for follow up, and compare adherence to the follow-up schedule,     number of clinical contacts, and outcomes of the abortion. This study will be performed at     two clinics in Toronto, the Bay Centre for Birth Control (BCBC) and the Choice in Health     Clinic (CIHC).      Primary Hypothesis: Follow-up will be more successful with RFU, compared to SFU.   "
102594|NCT01943266|"     Minimal data are available on protein requirements throughout the lifespan. Currently     available recommendations are based on nitrogen balance data. The limitations of the nitrogen     balance method have been well described. Importantly, nitrogen balanced underestimates     requirements.      The current dietary reference intakes (DRI) requirement for healthy adult males is based on     the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was     reanalyzed statistically by Rand et al. and he concluded that the protein requirement of     healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using     indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young     men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).      Currently there are no studies on protein requirement in the elderly. In a recent nutrition     survey conducted by national health and nutrition examination survey (NHANES), the authors     concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0     g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on     the calculations used for ideal body weight some older adults could be getting higher or     lower than requirement. There is no scientifically derived protein estimate for older adults.     Therefore there is a need to measurer protein requirement in that population.      The goal of this study therefore is to measure the protein requirement of male elderly     subjects between the ages of 65 - 75 years using the IAAO technique.   "
102595|NCT01943253|"     1. Introduction The aim of the study is to evaluate the efficacy and safety of ESD by use          of a new water-jet assisted ESD system using the HybridKnife® in patients with early          gastric neoplastic lesions in comparison to the conventional ESD established in Japan.          The water-assisted ESD technology allows pressure controlled injection of fluids through          the tip of a recently developed HybridKnife®. Submucosal injection, circumferential          cutting and dissection of lesions as well as coagulation of bleeding can be performed          with the same device without need for changing the instrument. These options should          accelerate the procedure and may increase its safety and efficacy.        2. Hypothesis The water-jet assisted ESD technique using the HybridKnife® bears the          advantage of less instrument changes due to the combination of high-frequency cutting          and water-jet application in one single instrument. This should lead to a simplified ESD          procedure, shorter learn-ing curve and especially to a shorter procedure time.      The water-jet assisted ESD technique should be shorter than the conventional ESD techniques     using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.   "
102596|NCT01943240|"     Our routine practice for patients undergoing mastectomy is to include paravertebral     peripheral nerve blockade for postoperative analgesia. This study investigates whether the     addition of another nerve block targeting the pectoral nerves will improve that analgesia.   "
102597|NCT01943227|"     This is a single site, prospective, non-blinded, non-randomized, non-interventional study     designed to evaluate the effect of changes in alveolar minute ventilation on the measurement     of respiratory heat loss (enthalpy).   "
102598|NCT01943214|"     By analyzing the relationship between the body constitution and the progression of Type II     diabetes mellitus, its morbidities, mortality and the impact of the life quality, we try to     provide an useful tool, body constitution, to stratify the patients accordingly for     individualized health care.   "
102599|NCT01943201|"     Introduction:      It is known that people with spinal cord injury (SCI) bear a considerably increased risk of     developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk     factors. It was the aim of the study to examine the effects of a specially developed     low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients     with SCI.      Method:      Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be     recruited. Each patient spends five consecutive nights on the new, respectively, conventional     bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS)     concerning well-being, odour, perspiration and wrinkling. In addition, the patients are     examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin     blood circulation in the parasacral region.   "
102600|NCT01943188|"     This pilot phase I trial studies the side effects and best way to give stereotactic body     radiation therapy and T-cell infusion in treating patients with metastatic kidney cancer.     Giving total body irradiation before a T-cell infusion stops the growth of cancer cells by     stopping them from dividing or killing them. After treatment, stem cells are collected from     the patient's blood and stored. Chemotherapy is given to prepare the bone marrow for the stem     cell transplant. The stem cells are then returned to the patient to replace the blood-forming     cells that were destroyed by the radiation therapy.   "
102601|NCT01943175|"     This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining     stem cells which is derived from adipose cells of subjects with heavy genetic loading for     schizophrenia then differentiating them into neuronal cells.   "
102602|NCT01943162|"     This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic     Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation     principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART)     intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of     SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and     treatment compliance in those with a history of mild to moderate TBI and persistent cognitive     complaints.   "
102603|NCT01943149|"     The purpose of this study is to monitor outcomes of total hip arthroplasties performed with     E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing     surface in total joint replacements for half of a century. Radiation, the most common form of     sterilization, unfortunately it results in the creation of free radicals (atoms or molecules     that cause chemical reactions with other substances) within the materials which cause the     breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX,     mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while     maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting     bearing surface in total hip arthroplasty that meets or exceeds current wear rates after     being placed in a patient.   "
102604|NCT01943136|"     This study will be an investigator-blinded, patient-blinded, assessor-blinded,     parallel-group, randomized clinical trial. It aims to evaluate the efficacy of one-week     twice-daily application of topical papaya leaf extract ointment compared to mupirocin     ointment in achieving clinical cure among patients with impetigo.   "
102605|NCT01943123|"     This study was conducted to assess the effects of commercially available probiotic drink on     the number of salivary mutans streptococci in school going children, aged 12-14 years in     Bangalore city in India   "
102606|NCT01943110|"     The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery     devices can safely and precisely inject liquid into the intradermal layer of the skin in     three different injection locations   "
102607|NCT01943097|"     Neuroblastic tumors are childhood neoplasms that possess amino acid decarboxylase (AADC)     activity and Meta-iodobenzylguanidine(MIBG), they can theoretically be imaged by     (18)F-fluorodihydroxyphenylalanine ((18)F-FDOPA) and     (123)I-Meta-iodobenzylguanidine((123)I-MIBG) PET, they are new and specific diagnostic and     follow-up tools for neuroendocrine tumors. In this study, we explored the accuracy and     clinical role of (18)F-FDOPA and (123)I-MIBG PET in neuroblastic tumors.      METHODS:      Patients with tissue-proven neuroblastic tumors receiving (18)F-FDOPA PET or (123)I-MIBG at     initial diagnosis or during follow-ups were enrolled. The sensitivity and specificity of     (18)F-FDOPA or (123)I-MIBG PET were compared to each other and compared to(18)F-FDG PET,     using tumor histology as the standard.   "
102608|NCT01943084|"     This trial is conducted in the United States of America (USA). The aim of the trial is to     investigate the bioequivalence (the expected biological equivalence of two pharmaceutical     drug products with identical active ingredient) of Norditropin® (somatropin) versus     Genotropin® (somatropin) in healthy adult subjects.   "
102609|NCT01943071|"     Attending day care centres with programs specifically designed for patients with dementia is     believed to postpone admittance to nursing home as well as increase quality of life and     well-being for both patients and their family caregivers. We aim to investigate to what     degree attendance in day care centres with programs for people with dementia is effective for     patient and their caregivers whilst also cost efficient for society. The study consists of a     quasi-experimental trial with comparison group. 400 patients with dementia, along with a     family caregiver, will be included in the trial. Effects will be measured at baseline, after     one and two years. Data collection will be made at three levels; at patient level with     measures of cognition, depression, quality of life, functioning in activities in daily     living, neuropsychiatric symptoms and death; at caregiver level with measures of depression,     level of burden and quality of life; and at societal level with measures of nursing home     admittance, hospital stays and use of other health resources. Additionally,a qualitative     interview study will include 20 dyads from the main trial. The main focus will be on how     attending day care centre programs for patients with dementia affect the lives of both     patients and caregivers. Five of these dyads will be followed closely throughout the     participation period to be used as case examples.   "
102623|NCT01942889|"     On the basis of published data and investigators results indicating that systemic redox in     balance may contribute to the peripheral muscle dysfunction in COPD patients, the     investigators propose a study testing the effects of antioxidants and exercise training in     COPD patients. The results may have major implication in the improvement of pulmonary     rehabilitation benefits   "
123229|NCT01673009|"     THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients     with plexiform neurofibromas   "
102610|NCT01943058|"     This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing     intrauterine system works in treating patients with atypical endometrial hyperplasia or     endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone     therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight     endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known     whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system     in treating atypical endometrial hyperplasia or endometrial cancer.   "
102611|NCT01943045|"     The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in     patients with Type 2 Diabetes.   "
102612|NCT01943032|"     The purpose of this study is to determine discordant hormonal status of primary breast tumor     and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer     patients.   "
102613|NCT01943019|"     Approximately one third of patients with schizophrenia show a poor response to standard     treatment with antipsychotic medications. This treatment resistant group of patients     represents a major challenge in everyday psychiatry, and consumes a disproportionate amount     of time from the clinicians, resulting in considerable costs to the society and government.     Anecdotal evidence suggests that the enzyme dipeptidyl peptidase IV (DPPIV) may be altered in     patients with schizophrenia, with a higher level DPPIV enzyme activity being noted. We     postulate that this may play a role in the neuropathology of schizophrenia patients and by     inhibiting the DPPIV enzyme activity with a DPPIV inhibitor such as linagliptin, we will be     able to improve and even ameliorate the symptoms of schizophrenic patients. However, until     now there have yet any studies on the potential of these inhibitors in schizophrenia     patients. A pilot study is thus proposed to evaluate the potential of the DPPIV inhibitor,     linagliptin as an adjunct in schizophrenia patients who are non-responsive to treatment,     which will establish the feasibility of a larger trial.   "
102614|NCT01943006|"     Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid     cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment     is continued after the end of infusion for at least 7 days.      Number of patients developing superficial phlebitis and duration of phlebitis will be     recorded.   "
102615|NCT01942993|"     Approximately 40-60 % of cutaneous melanomas select for a mutation in a protein called BRAF     which is part of a signaling pathway called the Mitogen Activated Protein Kinase (MAPK)     pathway. When BRAF is mutated the MAPK pathway remains active allowing for melanoma to grow.     Vemurafenib is an oral treatment which blocks the activity of BRAF which leads to decreasing     the activity of the MAPK pathway. When patients with melanoma expressing specific mutation in     BRAF are treated with vemurafenib approximately 50% will develop a response to treatment with     shrinkage of tumor. When compared to a standard chemotherapy called dacarbazine used to treat     melanoma, treatment with vemurafenib leads to a statistically significant overall survival or     living longer benefit. Because of this survival benefit vemurafenib was Food and Drug     Administration (FDA) approved for the treatment of metastatic melanoma expressing a BRAF     mutation called V600E BRAF. There is increasing evidence that the immune system can also be     important in affecting melanoma growth and survival and there are immune treatments FDA     approved for the treatment of metastatic melanoma. There is some limited evidence that     blocking BRAF with vemurafenib may affect the activity of components of the immune system. It     is important to better characterize and understand the effects of vemurafenib treatment on     various components of the immune system. The purpose of this study is to systematically     evaluate the effects of vemurafenib treatment (at FDA approved dosing regimen) on parts of     the immune systems called the innate and adaptive immune systems. The hypothesis is that     vemurafenib treatment will affect the immune system.   "
102616|NCT01942980|"     The incidence of brain metastases (BM) in metastatic breast cancer is increasing, due to the     improvement in the control of systemic disease, and due to an improved detection through     imagery.      The treatment management of single BM remains controversial. Indeed, even though it is widely     accepted that local treatment increases the median survival time in patients having a good     prognostic status, the adding of adjuvant whole-brain radiation therapy (WBRT) is currently     subject to controversy, due to its potential toxicity. Yet, two randomized trials have     demonstrated a clear increase in intra-cerebral recurrence and in death from neurologic     origin in case of absence of adjuvant WBRT, without change in overall survival (but overall     survival was not a primary endpoint in any of these studies).      The data from literature on cognitive toxicity (CT) of WBRT on BM are scarce and sometimes     controversial. CT of WBRT affects the subcortical frontal functions. It is postulated that     the alteration of hippocampal neurogenesis (mainly due to inflammation process), situated in     the subgranular zone of the dentate gyrus, has an essential role in the development of these     brain dysfunctions.      It has been shown that the incidence of BM in the hippocampal region (hippocampus + 5mm     expansion) is low, in the range of 8,6%.      New irradiation techniques, in particular intensity-modulated radiotherapy associated with     rotational radiotherapy, allow to modulate the dose on an intra-cerebral structure, all the     while distributing an adapted dose to the remaining brain.      This prospective, randomized study, will compare, through a battery of neuropsychological     tests, the cognitive impact of WBRT of 40 Gy in 20 fractions with or without hippocampal     avoidance by intensity modulated radiotherapy, in patients presenting with a single operated     brain metastasis of breast cancer. If the hippocampal avoidance leads to a significant     improvement in cognitive function, this radiotherapy scheme could become the standard     postoperative treatment to be proposed to patients presenting the best prognostic factors.     This would allow to prevent long-term cognitive deficit, while preserving WBRT benefit on     intra-cerebral control.      Justification of evaluation criteria :      Principal criteria :      Evaluation criteria to assess cognitive toxicity have been selected on the basis of the     recommendations from C. Meyers and P. Brown, who propose an adapted test battery to evaluate     memory, verbal function, visual and motor coordination, and executive function. The selected     tests have been validated, also in French. They comprise HVLT-R (Hopkins Verbal Learning Test     Revised), COWAT (Controlled Oral Word Association Test), Grooved Pegboard test, TMT A and B     (Trailmaking tests A and B), and MMSE. The calculation of patient numbers was based on the     HVLT-R test, as memory is thought to be the most frequently affected domain.      The tests will be performed before treatment (baseline cognitive function), at 4 months and     at 12 months. In case of a missing answer to the evaluation tests, the reason(s) for not     answering will be noted.      Secondary criteria :      Quality of life : QLQ-C30, QLQ-BN20, ADL, IADL Intra-cerebral Progression-free survival (PFS)     Overall survival.   "
102617|NCT01942967|"     The purpose of this study is to examine the blood flow and the delivery of oxygen to the     brain and gut in preterm babies while they are supported with two modes of breathing machine     and compare these two methods to see if one allows for better blood flow to the brain and     gut.   "
102618|NCT01942954|"     The consequences of alcohol dependence are severe and may range from physical diseases to     neuropsychological deficits in several cognitive domains. Alcohol abuse has also been related     to brain dysfunction specifically in the prefrontal cortex. To assess these deficits and the     application of a novel approach of cognitive stimulation to alcoholics, we have carried out a     neuropsychological intervention program with mobile health technology. Patients diagnosed     with alcohol dependence syndrome were submitted to cognitive stimulation during four weeks in     a three-day/week basis.   "
102619|NCT01942941|"     A study to see what effect the geko™ device has on blood flow in patients with lower limb     vascular disease.   "
102620|NCT01942928|"     Background Excessive Crying (Infantile Colic) is one of the most common complaints for which     parents seek treatment. These otherwise healthy and well fed infants show no signs of failure     to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe.      Objective To explore the feasibility of running a Randomised Controlled Trial (RCT) that     investigates the effectiveness of cranial osteopathy in addition to usual National Health     Service (NHS) care in infants with colic.      Methods Pragmatic randomised controlled trial, involving United Kingdom (UK) osteopaths in     private practice and NHS health visitors. Parents of 60 excessively crying infants/infants     with colic will be recruited by NHS health visitors. Infants will be included into the study     if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive crying/infantile     colic, and have no co-morbidities. Participants will be randomised into the usual NHS care     group or the usual NHS care plus cranial osteopathic intervention group.      Usual NHS care will be provided by health visitors and osteopathic treatment will be carried     out by experienced osteopaths in private practice.      Primary outcome measures are acceptability and feasibility of intervention procedures.     Furthermore, changes in the frequency and duration of crying will be documented in a daily     crying diary. Parental quality of life will also be assessed.      This pilot investigation will provide useful information in order to further develop and     adapt the current interventions and trial procedures with a view to a full-scale randomised     controlled trial.   "
102621|NCT01942915|"     This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells     transplantation in liver cirrhosis patients.   "
102624|NCT01942876|"     The proposed study will address the critical need to reduce illegal drug use, in particular     drug use, and the occurrence of drug-related harm in low-income racially diverse patient     populations at urban primary care safety-net clinics. Since they are at risk for accelerated     trajectories to drug dependence once drug use begins, low-income racially diverse populations     pose particular concern for public health policy makers and drug-use prevention efforts. The     study will be the first to standardize drug screening and primary-care clinician delivered     brief intervention among racially diverse at risk drug users, that is users with casual or     frequent use without the physiological or psychological manifestations of dependence, to     reduce their 'at risk' use of drugs, and it may effectively interrupt their pathway to     dependence.   "
102625|NCT01942863|"     Enteroscopy, including double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and     spiral enteroscopy (SE) currently, have shown good performances in small bowel diagnostics     and seem to be useful in the clinical routine. However, enteroscopy is a time-consuming     procedure. During common practice, large volumes of air need to be insufflated for good     visualization. It leads to significant distention of the small bowel during the examination,     which makes further intubation more technically challenging because of the formation of     distended bowel loops and acute angulations and limits the maximal intubation length.     According to the published data, the oral insertion depth of different kinds of enteroscopy     is limited to approximately 240 cm. The total examination rate range form 18% to 86% for DBE     and 0% to 11% for SBE.      It is thought that the intubation depth in small bowel determines the diagnostic yield and     the following treatment. The deeper the enteroscopy is advanced into the small bowel, the     more lesions may be found and treated. In order to improve the intubation depth of balloon     enteroscopy, several methods, such as carbon dioxide insufflation and decompression side     tube-equipped device, have been tried and showed positive effects. CO2 insufflation could     also reduce severe pain during DBE and residual gas retention after the procedure because of     rapid absorption. However, it is not known how much CO2 insufflation can decrease the     distention of small bowel and the formation of bowel loops.      Recently, the use of water infusion in lieu of air insufflation has been shown to facilitate     completion of colonoscopy, even in potentially difficult patients with prior abdominal or     pelvic surgery. Water exchange method obviates excessive lengthening of the colon and the     formation of acute angulation, which may cause less pain and easier intubation during scope     insertion. Recently, water exchange method was also tried in two patients undergoing SBE via     antegrade route in our center. Distal ileum 8cm near to ICV and the cecum was reached     respectively (unpublished data), indicating water exchange be a useful method for deep     intubation of SBE.      Here a prospective, randomized, controlled trial was designed to investigate whether,     compared with CO2 insufflation method, water exchange method could increase the intubation     depth and diagnostic yield in patients undergoing SBE.   "
102626|NCT01942850|"     The project will collect information on the mapping of clinical ratings on a number of scales     that are used in the assessment of patients with ataxias.   "
102627|NCT01942837|"     This research study is evaluating a drug called enzalutamide in metastatatic castration     resistant prostate cancer.Enzalutamide is already FDA approved for metastatic castration     resistant prostate cancer after treatment with chemotherapy. The purpose of this study is to     analyze features of tumor specimens sampled prior to therapy and at disease progression to     determine why patients respond or stop responding to treatment with Enzalutamide. Prior     chemotherapy is not a requirement of this trial. Enzalutamide is a drug designed to block the     effects of male hormones in the body that may be helping prostate cancer to grow. It has     already been approved by the FDA (the U.S. Food and Drug Administration) for patients with     castration-resistant prostate cancer who have received prior chemotherapy.      Additionally, this study will analyze features of tumor specimens sampled prior to therapy     and at disease progression to determine why patients respond or stop responding to treatment     with enzalutamide.   "
102628|NCT01942824|"     Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations annually.     While vaccination is the cornerstone of preventing influenza infection, vaccination coverage     in adults is low with only 35% vaccinated by end of November. Latino adults have the lowest     coverage rates. Text message reminders have been used successfully for improving influenza     vaccination for children. This study will assess the use of text messaging to improve     influenza vaccination coverage rates in a largely minority, publicly insured adult     population.   "
102629|NCT01942811|"     The goal of the US-Mexico Binational Quit Using Drugs Intervention Trial (QUIT) is a     multi-site study conducted in the US (East Los Angeles) and Mexico (Tijuana) which aims to     reduce drug demand on both sides of the border. The study also aims to build a collaborative     partnership between the US and Mexico research teams. The Bi-National QUIT Study will conduct     a randomized control trial for risky drug use in several Los Angeles area community health     centers. The intent of the trial is to interrupt the progression to addiction for the casual     and occasional users of illicit drugs and non-medical users of pharmaceuticals. The     Bi-National QUIT protocol will include (1) a computerized assessment of the patient's     drug-use history (2) very brief (<5 minutes) clinician advice during a patients pre-arranged     medical visit which will be preceded by a computerized assessment of the patient's drug-use     history (3) a post visit assessment and video doctor (repeating the very brief clinician     advice) in the waiting room (4) two post-visit telephone drug-use counseling sessions to be     conducted by drug-health educators at approximately 2 and 6 weeks after the start of the     intervention. Follow-up assessments will be conducted at 3 months post-randomization.     Parallel activities will take place in the U.S./Los Angeles sites and Mexico/Tijuana sites.     Data will be shared between both teams. Data analysis will be collaboratively conducted by     both teams.   "
102630|NCT01942798|"     WiiNWALK is a 4 week physical activity, with the intervention of a WiiFit, targeted to     improve walking capacity in individuals with either a unilateral below-knee or above-knee     amputation. This is a randomized control trial to evaluate the effectiveness of the WiiNWALK     program in older (50+ years) community living adults with lower limb amputations (LLA).      Hypothesis: We expect the WiiNWALK intervention will have a treatment effect with improvement     in functional walking capacity, compared to the control group who will only be playing     cognitive games. Secondarily, a functional walking capacity will also include an improvement     in lower extremity strength and balance, inter-limb gait symmetry, balance confidence along     with participation in daily and social activities, locomotor capabilities and an increase in     physical activities.   "
102631|NCT01942785|"     To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a     naturalistic setting of depressed patients with irritability.   "
102632|NCT01942772|"     Ankle rehabilitation training becomes a tough question for the patients with ankle joint     injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot     orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric     motor is proposed in this paper. The mechanical structure of the orthoses includes wearing     parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This     study provides a new method for ankle foot orthoses design and has great significance for     ankle rehabilitation.   "
102634|NCT01942746|"     Clinical evidence for effects of plant anthocyanins on vision, and particularly night vision     is controversial. Two clinical trials were conducted to investigate whether blueberry juice     consumption affected visual dark adaptation, functional night vision, and recovery after     photo-bleaching of the retina. One trial (S2) employed a 3 week intervention and washout     period, and two doses of blueberries plus a placebo. The other trial (L1) employed a 12 week     intervention plus an 8 week washout and tested one blueberry juice dose against a juice     placebo.   "
102635|NCT01942733|"     To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep     disturbances.   "
102636|NCT01942720|"     This study is designed to evaluate the performance of VCE in the assessment of mucosal     inflammation 6 months after the first VCE procedure   "
102637|NCT01942707|"     46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains     insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa     removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when     the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total     drainage obtained in the drains of the abdominal region. Secondary outcomes will be the     length of time the drains remain and the presence of seroma assessed by ultrasound on the     twentieth postoperative day.   "
102638|NCT01942694|"     The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D     supplementation works to delay the onset of type 2 diabetes in people at risk for the disease     and to gain a better understand how vitamin D affects glucose (sugar) metabolism.   "
102639|NCT01942681|"     This study is to evaluate the efficacy and safety that the occurrence of incontinence is     significantly decrease using the propiverine hydrochloride for 200 female patients with mixed     (stress and urge) urinary incontinence in one week during a twelve-week treatment period.   "
102640|NCT01942668|"     This study will be a prospective, randomized, double-blind, placebo-controlled, parallel     group, multicenter trial of postmenopausal subjects with an intact uterus.   "
102641|NCT01942655|"     Progressive HIV or HIV infection seems to be related to a preferential loss of CD4+ T     lymphocytes, especially Th17+, within the mucosal intestinal lymphoid tissue, and with     intestinal mucosal damage and bacterial product translocation, which correlates with the     hyperactivation of the immune system, therefore with CD4+ T cell loss and prognosis. The     objectives of this project are to investigate the correlation between the IL12/IL-23     imbalance and bacterial product translocation, and to study the polarization, infection or     depletion of intestinal Th17 ex vivo. The investigators will test the effect of neutralizing     anti-IL23 antibodies directed against p40, or less classically, anti- IL-23 p19.   "
102642|NCT01942642|"     Meibomian gland dysfunction (MGD) is a common and important disease has been investigated the     pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD after     the cataract surgery, the most popular surgery to ophthalmologist, had not been evaluated.     The investigators evaluated parameters related with MGD including lid margin abnormalities,     meibomian gland expressibility and meibography before and after surgery.   "
102643|NCT01942629|"     The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many     studies have reported that overexpression of p63 can mimic p53 activities by binding DNA,     activating transcription, and inducing apoptosis.      Various studies proved p63 as a marker of basal cells in normal salivary glands, breast,     prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies.     Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast     carcinoma, and no study has described the correlation of p63 with pancreatic ductal     adenocarcinoma.      In the current study, we aim to evaluate the prognostic value of the expression of p63 in the     lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will     achieve this aim by collecting clinical data retrospectively from the patients' medical     records as well as assessing the histological sections and performing immunohistochemical     staining for p63.   "
102644|NCT01942616|"     We propose an experimental design to empirically establish the potential link between the     media portrayal of DV and changes in an individual's DV descriptive and injunctive social     norms. Specifically, this study will measure the degree to which people implicitly collude     with DV perpetration.   "
102645|NCT01942603|"     The purpose of this registry is to collect data in order to discover whether melanoma     patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND)     or not.      Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a     CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal     basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some     centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND     procedure does not increase survival for patients with a minimal SN tumor burden, but can add     prognostic information, potentially useful in the subsequent decision-making process.     However, this is a surgical operation for the patient, which might be accompanied by     significant side effects. Moreover, only approximately 20% of patients with a metastatic SN     have further lymph node metastases in the same basin, which means that about 4 patients out     of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN     positive patients could be safely spared from a CLND. It has been demonstrated that breast     cancer patients with minimal SN tumor burden can be safely managed with nodal observation     only, without performing a CLND. There is evidence that the same situation exists in melanoma     as well, but this needs to be validated and this is why we are conducting this registry.      The results of this registry will be crucial to establish an accepted standard of care (CLND     or nodal observation) for melanoma patients with minimal SN tumor burden.   "
102646|NCT01942590|"     Funding Source- FDA OOPD      The purpose of this study is to investigate the safety and efficacy of clenbuterol on motor     function in individuals with late-onset Pompe disease (LOPD) who are treated with enzyme     replacement therapy (ERT).   "
102688|NCT01942044|"     The purpose of this study is to evaluate the differences of wall shear stress distribution     among different types of drug-eluting stents and its impact on vessel healing evaluated by     intravascular optical coherence tomography evaluation.   "
104893|NCT01913158|"     The primary objective of this study is to determine the safety and efficacy of G&W     Laboratories' Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects     with internal hemorrhoidal symptoms.   "
102647|NCT01942577|"     The skin and intestinal tracts of humans are covered with microbes, and the gene products of     these microbes are collectively known as the human microbiome. Many studies in recent years     have linked the microbiome to many aspects of human health and disease. Premature infants are     vulnerable to invasive infections, some of which may originate from the microbes that     colonize the skin and in the intestinal tract. Therefore, determining the patterns of early     life colonization and the sources of colonization in these infants may be critical to     determining infectious risks. This prospective study is proposed to identify the sources of     microbes that colonize extremely low birth weight (ELBW; <1000 g birth weight) infants     immediately following birth through the first month of life. The study team plans to     non-invasively survey the skin and stool of ELBW preterm infants in combination with sampling     of their mothers' skin and stool and the intensive care nursery (ICN) environment. As     controls, the study team will perform a similar survey of full term mother-infant pairs.     Samples will be analyzed using high throughput sequencing techniques to determine microbial     content.      Topical barrier sprays or emollients are commonly used early in life in the ELBW infant to     reduce insensible water loss and enhance the integrity of the skin barrier. The effect of     these treatments on the development of the skin microbiome remains unknown. As part of this     study, the study team also proposes the application of two different skin barrier therapies     to small areas on infant's legs to determine the effects of the different treatments on skin     colonization. While all parts of the study are described in this summary and the detailed     description, the remainder of the record focuses on this interventional portion of the study     (Group 2).      The goals of this study are outlined as follows:        1. To elucidate the relationship between microbes in the health care environment and          colonization patterns of the intestinal tracts in preterm and term infants.        2. To understand the relationship between mode of delivery, the health care environment,          and the colonization of the skin in preterm and term infants.        3. To determine the effects of topical skin barrier therapies on the colonization patterns          of the skin in preterm infants.        4. To ascertain the relationship between the composition of the microbes colonizing preterm          and term infants and the development of mucosal and systemic immunity to those microbes.   "
102648|NCT01942564|"     After a head injury, many people find that exposure to light causes them increased     discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue     light, this study will investigate whether this phenomenon is due to a change in the eye's     sensitivity to light.   "
102649|NCT01942551|"     This is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and     pharmacokinetic interaction after oral concomitant administration of tadalafil and     dutasteride in healthy male volunteers.   "
102650|NCT01942538|"     Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with     fibromyalgia may maintain the clinical improvement.   "
102651|NCT01942525|"     Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and     long-term neurodevelopmental outcome has been published in numerous studies. Throughout this     analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm     infants below 30 weeks of gestation was assessed. The second concern was the correlation     between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome,     comparing infants with and without IUGR.      Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of     gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG     score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure     activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of     Infant Development and standardized neurologic examination.   "
102652|NCT01942512|"     Endovascular treatment is now the first line treatment for the management of intracranial     aneurysms. However aneurysm recanalization is an important limitation to this treatment.     Several factors seems to be associated with aneurysm recanalization including medical history     of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location,     modalities of treatment, immediate post-operative occlusion of the aneurysm.      A precise knowledge of factors increasing the risk of aneurysm recanalization is quite     important to optimize strategy of treatment and reduce the recanalization rate. No large,     prospective, multicenter trial dealing with this question has been published in the     literature.   "
102653|NCT01942499|"     It is well established that individuals living with chronic obstructive pulmonary disease     (COPD) demonstrate significant improvements following a formal rehabilitation program. The     problem lies in the fact that these functional improvements diminish over a 12 month period.     This decline in function is associated with decreased participation, a decline in health     status, and an increased need to access the healthcare system. The objective of this project     is to evaluate the effectiveness of a post-rehabilitation community-based exercise program     for individuals with COPD and compare the outcomes with those achieved through standard care.      Individuals with COPD who have completed a previous rehabilitation program will be enrolled     in the study. Study participants will be assigned randomly to either a year-long community     exercise program or usual care. Those assigned to the community program will exercise twice     weekly at a local community centre supervised by trained fitness instructors. A case manager     will facilitate the transition from the hospital rehabilitation program to the community     centre. The case manager will also be available to participants and instructors for consult     as needed. Continuing to build on an established partnership with the City of Toronto, the     case manager will ensure fitness instructors receive specialized training in order to     properly supervise and support the individuals with COPD. Participants assigned to usual care     group will receive standard care by their family physician and respiratory specialist.     Functional status will be evaluated before the program begins and again at 6-months and     1-year. The outcome of each group will be compared to determine the effectiveness of the     community exercise program. It is hypothesized that individuals who participate in the     community exercise program will have better function and quality of life versus those     individuals who receive standard care.   "
102654|NCT01942486|"     The purpose of this study is to determine if a special coating, applied to the surface of     glasses can reduce the frequency and severity of migraine headaches in children and     adolescents. This study is being conducted by researchers at Primary Children's Medical     Center, The John Moran Eye Center, and the University of Utah Department of Electrical     Engineering. The investigators have determined that a specific frequency of light is     particularly bothersome to migraine patients. The coating they've developed is designed to     block this frequency of light. Very few treatments are approved for the treatment of     childhood migraine. The investigators hope that these glasses will provide a safe way to     improve headaches in children.   "
102655|NCT01942473|"     In this study the investigators test the hypothesis that automated FiO2 adjustment increases     the time of brain tissue oxygenation within the intended reference range. Furthermore, the     investigators studied the change in workload during automated FiO2 adjustment as compared to     manual adjustment by the nursing staff.   "
102656|NCT01942460|"     The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of     iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney     disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact     of the administration of a ferumoxytol dose on various markers for iron stores, as well as on     various markers for inflammation and oxidative stress.   "
102669|NCT01942291|"     Individuals with reduced plasma concentration of high-density lipoprotein (HDL) cholesterol     are more susceptible to oxidative stress and often present reduced endothelial function,     which has been mainly related to this susceptibility. Studies in animal and cell models have     demonstrated that niacin activates both GPR-109A in leukocytes and heme oxygenase-1 (HO-1)     pathway promoting strong anti-inflammatory and anti-oxidative effects. . In this context, the     aim of this study was to investigate the short-term effect of niacin on endothelial function     and verify the existence of interaction of PGD2 receptor antagonist, i.e. laropiprant (LRPT),     in subjects with low HDL-cholesterol (HDL -C).   "
102657|NCT01942447|"     The host gastrointestinal microbiota is significantly influenced by antibiotic treatment     which might favor Clostridium difficile infection (CDI), a frequent cause of community- and     hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in     19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no     standardized therapy of recurrent or refractory CDI, but recent studies show remarkable     effects of fecal microbiota transplantation (FMT).      In the current project, we aim to ideally match host and donor for FMT success in recurrent     or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will     evaluate its safety and efficacy, and the patient acceptance and quality of life before and     after FMT. We will analyse persistence of the donor microbiota within the recipient, define     predictive clinical recipient and donor factors for FMT success and correlate them with     microbial host and donor metagenomics.      We hypothesize that our work will yield novel, individualized strategies for recurrent or     refractory CDI. In perspective, our results may be expanded to treatment of other inflammory     bowel diseases.   "
102658|NCT01942434|"     Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of     breastfed infants.      Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast     milk sample.      Phase 2: At 6 months of age child participates in electrophysiology session to test     recognition memory.      Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical     assessments.   "
102659|NCT01942421|"     The purpose of this study is to elucidate the appropriate condition of developing cultivated     autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation     of the cultivated cells in the patients.   "
102660|NCT01942408|"     Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart and     causes an irregular and often rapid heartbeat. Developing this condition may cause     significant health problems and symptoms that affect normal day-to-day activities. Patients     with AF also have a shorter life expectancy on average. Tablets used to try to normalise the     heart rhythm rarely work well. As a result, doctors have devised a treatment to try to cure     this condition. Special wires (called catheters) are used to deliver heat energy (called     ablation) on the inside surface of the heart. This technique has been used more and more in     recent years for patients with troublesome symptoms due to AF.      The aim of the treatment is to draw lines of ablation in specific places in the heart.     Unfortunately, a lot of patients (almost 50%) get AF again after this treatment and most of     these patients have a second treatment performed. It is usually found at this second     treatment that gaps have developed in the lines of ablation that were drawn the first time     around. The investigators think that electively doing a second treatment to close these gaps     a couple of months after the first treatment may mean that fewer of these patients will get     AF again in the future. The investigators also want to find out what factors make a line of     ablation less likely to develop gaps.      In this study, participants will be assigned to one of two groups:        1. a standard care group, who will have a single treatment initially.        2. a repeat study group, who will have the initial treatment followed by a second          treatment 8-10 weeks later.      For patients in the repeat study group, investigators will see how many have developed gaps     since their first treatment. The investigators will look at where these gaps are and will     compare this with information collected during the first treatment to try to work out why the     gap has developed. Any gaps found at the second treatment will be closed again.      All participants will then be monitored carefully over 12 months to see how many from each     group get AF again. To do this, all participants will be given a handheld heart rhythm     monitor to keep until the end of the study. This device is simple to use. Participants will     be asked to make a 30 second recording of their heart rhythm each day and also whenever they     have symptoms. These recordings will be downloaded at review appointments arranged 6 weeks, 3     months, 6 months and 12 months after the initial ablation procedure.   "
102661|NCT01942395|"     The purpose of this study is to examine how dietary changes affect the heart and blood     vessels in patients with hypertension (high blod pressure) who have a condition called 'heart     failure with preserved ejection fraction (HFPEF). This condition is also known as diastolic     heart failure or heart failure with normal ejection fraction, and occurs even though the     heart's pumping function is normal.   "
102662|NCT01942382|"     The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to     a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in     repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or     gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.   "
102663|NCT01942369|"     The purpose of this study is to describe changes in the intensity of specific endometriosis     symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline     (Triptorelin Acetate) treatment for up to 24 weeks.   "
102664|NCT01942356|"     The purpose of this study is to compare a closed-loop intravenous anesthetic using Bispectral     Index as a feedback loop and a controller based on reinforcement learning to titrate dose and     intravenous anesthetic that is manually controlled or a standard volatile anesthetic agent     titrated by the anesthesiologist to determine improvement in the following parameters as     compared to controls: time to discharge from the Post Anesthesia Care Unit, post-operative     nausea and vomiting, pain scores and sedation scores.   "
102665|NCT01942343|"     The main objective of this study is to evaluate the incidence of akathisia with Droperidol,     the prophylactic treatment of post operative nausea and vomiting, used at two different     doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to     compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg     and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that     there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO,     that among patients taking Ondansetron.   "
102666|NCT01942330|"     This study aims to prospectively evaluate a laparoscopic-assisted transvaginal approach for     colonic resection in adult women that eliminates the need for an abdominal incision to remove     surgical specimens. It is hypothesized that this LANOS technique will improve patient     outcomes such as postoperative surgical site infection (SSI) rates, thereby improving patient     satisfaction and also reducing hospital length-of-stay and cost.   "
102667|NCT01942317|"     The aim of the study is to evaluate the role of balneotherapy in obese patients with knee     osteoarthritis in terms of pain relief, improving joint function and deambulation, on     endocrinological parameters, quality of life and of reduction the costs to Servizio     Sanitario Nazionale (NHS).   "
102668|NCT01942304|"     The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and     histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS     putty bone substitute in posterior maxillary sites and the survival of implants placed in     these sites following healing.   "
102670|NCT01942278|"     BHOMA Interventions      The purpose of this study is to assess the impact of the BHOMA intervention on health in 3     rural districts of Zambia.   "
104894|NCT01913145|"     This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger     Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood     taken from the arm vein).   "
102673|NCT01942239|"     Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their     neurological outcome. The aim of this study was to compare real-time continuous glucose     monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose     testing in detecting and managing hypoglycemia. The investigators calculated a number of 48     neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days     of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing     (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The     investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will     be lower.   "
102674|NCT01942226|"     Dry eye is a common complaint in patients encountered by ophthalmologists, which may result     from the inflammatory response and can occur in the absence of systemic disease. However, the     management of dry eye syndrome in real setting warrants assessment but remains lacking in     Taiwan. We conducted an perspective observational study to evaluate the medical management of     dry eye patients.   "
102675|NCT01942213|"     This open-label, Phase IV prospective, observational study will evaluate patients, who have     been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received     either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and     compare information regarding post-injection inflammatory (irritation in the eye)2-3 days     post-injection.      Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.   "
102676|NCT01942200|"     The main purpose of this observational study with Oxaliplatin onkovis is to determine the     number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose     under the special circumstances of ambulant chemotherapy.      Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This     includes provision of appropriate packaging sizes to decrease the excess quantity to be     discarded, and thus also follows this objective.      Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this     end, data regarding co-medication and adverse events are also collected.   "
102677|NCT01942187|"     The purpose of this study is to compare the effectiveness of two different augmentation     strategies of antidepressant treatment for depressed older adults who have not responded to     an adequate trial of antidepressant medication. The first augmentation strategy is Problem     Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective     in depressed older adults. The second augmentation strategy is medication augmentation, which     will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also     been shown to be effective in depressed older adults who have failed a trial of     antidepressant medication.   "
102678|NCT01942174|"     To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by     the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and     who begin a treatement by methotrexate either in the same time, either 1 month later.   "
102679|NCT01942161|"     The objective of this study is to investigate the efficacy and safety of three different     doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period     of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia   "
102680|NCT01942148|"     The objective of this study is to investigate the safety and efficacy of aripiprazole     (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally     administered over a period of 52 weeks in subjects who complete a short-term treatment study     of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).   "
102681|NCT01942135|"     The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the     primary objective of demonstrating the superiority of palbociclib in combination with     fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2     negative metastatic breast cancer whose disease has progressed after prior endocrine therapy.     The safety between the two treatment arms will also be compared. During study treatment, pre-     and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex®     or generic).   "
102682|NCT01942122|"     This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for     the treatment of pain in patients suspected endometriosis. It is hypothesized that the     reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of     study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen,     is significantly greater than that of Control. In addition, the administration of DLBS1442 at     higher dose also results in significantly greater reduction than that of DLBS1442 at lower     dose and of Control.   "
102683|NCT01942109|"     The aim of the study is to compare the effects of torasemide and furosemide on clinical and     biochemical parameters of hemodynamic and neurohormonal compensation and myocardial     remodeling in patients with chronic heart failure with indications for use of loop diuretics.      The study protocol 100 patients with heart failure NYHA (New York Heart Association) II-IV     (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose     loop diuretics]) treated with optimal medical therapy as clinically indicated for use loop     diuretics. Patients will be randomized to treatment with furosemide and torasemide     (randomization 1 : 1). After randomization, furosemide will continue in its current     fixed-dose or will be replaced by equipotential dose of torasemide (4:1). The minimal     follow-up of patients in the study will be at least six months.   "
102684|NCT01942096|"     High school elite training programs are today more and more under development in several     'elite sport schools' in Belgium, in order to select and train future elite athletes already     at young age. Little is known about the effects of sustained training on the potential     development of asthma in adolescents during lung growth. It would be of great importance to     be able to select the individuals at risk to develop exercise-induced asthma, already at the     start of their enrollment in the 'elite sport school. This would allow physicians to follow     their lung function parameters very closely and regularly; and, if necessary, start treatment     early after the first signs of exercise-induced asthma.   "
102685|NCT01942083|"     This is a Phase I, open label, non randomized, multicenter study designed to investigate the     safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in     subjects with advanced HCC.   "
123316|NCT01671878|"     In this study, postprandial glucose and insulin responses of different foods will be measured     in individuals with varying body weight.   "
102689|NCT01942031|"     Stroke is a devastating disease. The acute mortality in Sweden is 20 % and 25 % of all     patients relapse. Secondary prevention is proven efficient but observational studies have     shown that a number of patients are lost to follow up and do not receive recommended     prevention. The aim of the study is to 1) describe, by analyzing register data, the detection     rate of patients with hospital diagnosis of stroke, TIA, and atrial fibrillation in the     primary care center where they are listed. The analysis is done by sex, age, and     socioeconomic status. Furthermore, rate of dispensed prescriptions of secondary preventive     drugs are analysed for the identified population. 2) in a randomized controlled study     evaluate if collegial feed back and targeted information of secondary prevention to the     intervention group can improve the detection rate and the medication of the patients listed     at the participating primary care centers.   "
102690|NCT01942018|"     This research is being done to study an endoscopic procedure called POEM as a less invasive     alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO).   "
102691|NCT01942005|"     Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.   "
102692|NCT01941992|"     The purpose of this study is to:        -  evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in          head-and-neck cancer patients undergoing chemo-radiotherapy.        -  assess tolerability of SAMITAL and the impact on patients reported outcomes.   "
102693|NCT01941979|"     Surgery is the most indicated curative treatment for rectal cancer when disease is diagnosed     early, however local recurrence risk increases when the disease is diagnosed at advanced     stage.T1-2 tumors have a recurrence rate lower than 10%, while T3N0 tumors have 15% - 35% and     positive lymph nodes T3-4 45% to 67% of recurrence rate within 5 years. These data indicate     that patient who have a high risk of tumor recurrence should receive an adjuvant therapy     treatment.      It is possible that adjuvant chemotherapy has a positive impact on survival of patients     already treated with neoadjuvant combination therapy. However it is necessary to identify     those patients that might have this benefit.      An exploratory analysis of the European Organization for Research and Treatment of Cancer     (EORTC) 22921 study showed that the addition of adjuvant chemotherapy has benefited only the     group of patients who had a reduction of tumor stage to ypT0-2. In the group who had no     reduction (ypT3-4), there was no benefit. Retrospective analyzes suggest that the response to     neoadjuvant chemoradiotherapy is a predictor of prognosis and even benefit to adjuvant     chemotherapy. However the benefit of adjuvant chemotherapy for patients with rectal cancer     remains controversial. Therefore, a randomized trial is needed to answer this question.      Based on these data the investigators proposed a phase III study, randomized, unblinded,     adjuvant chemotherapy based on Fluorouracil(5-FU) and Oxaliplatin versus observation in     patients with rectal adenocarcinoma T3-4, N0-1, M0 previously treated with neoadjuvant     chemoradiotherapy and who did not presented complete response. The investigator believes that     this subgroup of patients, who have not achieved complete response, will be benefit from     adjuvant therapy.      Study objective:      The main objective of this study is verify if adjuvant chemotherapy with 5-FU and     oxaliplatin, for 4 months, increases recurrence-free survival versus the observation.     Secondary objectives include the evaluation of toxicity, overall survival and assessment of     biomarkers (study protocol separately).      The study's primary endpoint is disease-free survival (DFS) to be defined as time from     randomization to radiological detection of distant disease and / or locoregional recurrence.     Isolate carcinoembryonic antigen (CEA) increase will not be consider as recurrence until a     new measurable lesion be found.      NOTE: The TNM system is based on the size and/or extent (reach) of the primary tumor (T), the     amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or secondary     tumors formed by the spread of cancer cells to other parts of the body.   "
102694|NCT01941966|"     The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which     corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been     growing recently. The standard treatment of anal cancer stage II-III is multimodal and     consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and radiotherapy.     This scheme currently used was proposed in 1974, and since then no other effective treatment     has been developed.      The purpose of this study is to determine the efficacy and toxicity of the combination of     capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal.     For this will be selected 51 patients to be treated with chemo-radiotherapy.      The primary endpoint will be local control rate after 6 months of the end of radiotherapy and     chemotherapy, defined by the rate of radiological and clinical neoplasia.   "
102695|NCT01941953|"     This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in     patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and     Irinotecan based chemotherapy.   "
102696|NCT01941940|"     This open-label, single arm, Phase 3b study will evaluate the efficacy of tocilizumab     (RoActemra), administered as monotherapy or in combination with methotrexate and/or other     DMARDs, in participants with moderate to severe active RA.   "
102697|NCT01941927|"     This is a multicenter phase II clinical study of trametinib in combination with GSK2141795 in     patients with BRAF wild-type mutation melanoma. All patients will receive continuous dosing     of trametinib (2 mg) in combination with GSK2141795 (25 mg) oral daily until progression of     disease, withdrawal of consent, or the development of intolerable treatment associated     toxicity. Imaging (CT or MRI) will be performed within 7 days prior to day 1 of Odd Cycles,     starting with Cycle 3.      Patients may continue treatment with trametinib in combination with GSK2141795 on trial until     disease progression or the development of unacceptable toxicity that does not improve with     maximal supportive care or dose reduction per protocol.      Treatment-associated adverse events will be assessed based on clinical and laboratory     findings using the Common Toxicity Criteria for Adverse Events, version 4.0. Adverse event     assessments will be performed every week through cycle 3 day 1, and on day 1 for every cycle     thereafter. AEs and SAEs will be monitored by UCSF's Data Safety Monitoring Committee.      Safety assessments will include medical history, physical examination, CBC with differential,     chemistries panel, thyroid function and pregnancy tests, ECGs, and ophthalmology evaluations.     Screening assessments will also include a transthoracic echocardiogram or MUGA scan, and     brain imaging.      It is estimated that 48 patients will complete the study.   "
102698|NCT01941914|"     The purpose of this study is to evaluate the effect of calcium electroporation on keloids.   "
102699|NCT01941901|"     The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous     metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.   "
102700|NCT01941888|"     Many studies address safety and effectiveness of non-anesthesiologist propofol sedation     (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for     providing optimal sedation regimen and avoiding under or oversedation.      This randomized double blind controlled study compares standard moderate sedation level of     sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS     (group P).   "
102777|NCT01940887|"     The objectives of this study are to evaluate the safety and efficacy of intravitreal     administration of Fovista® administered in combination with either Avastin® or Eylea®     compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal     neovascularization secondary to age-related macular degeneration (AMD).   "
102701|NCT01941875|"     This is a study of patients undergoing Controlled Ovarian Hyperstimulation (COH) with     Gonadotropins and Intrauterine Insemination (IUI) at a Fertility Clinic.      Infertility is a common problem, and a popular method of therapy is to inject sperm through     the cervix and into the uterus, a procedure known as IUI. In conjunction with IUI, injectable     medications (gonadotropins) are used to stimulate the ovaries to produce more than one egg     per cycle in a process called COH.      Vaginal progesterone is used for luteal support in in vitro fertilization therapy and has     been proven to effect pregnancy rates. However, the role of progesterone in COH is still     unclear. In this study, the investigators want to examine the effect of giving vaginal     progesterone after COH with IUI on pregnancy rates. The investigators want to study if luteal     vaginal progesterone results in a higher pregnancy rate compared to no progesterone therapy     in COH with IUI. At present, fertility centres vary in the use of progesterone after     insemination, most likely due to the lack of studies on this subject.      At the Fertility Clinic all patients undergoing COH with injectable medications and IUI,     regardless of whether they are in the study, have a baseline transvaginal ultrasound and     blood tests. Patients start the injectable medications for COH until the ovarian follicles     are large enough, then a medication to release the eggs is given. The IUI is done     approximately 36 hours later. The day after the IUI, study patients will be given vaginal     progesterone while the control patients will receive no progesterone. All patients will be     followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.   "
102702|NCT01941862|"     The purpose of this study is to test the effectiveness and usability of multiple     computer-based treatments for mood and anxiety relevant risk factors. The target of the     treatment is related to cognitive stress, which has been shown to be associated with a     variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal     ideation, and substance use disorders.   "
102703|NCT01941849|"     The phase I trial aims to determine the recommended phase II dose (RP2D) of vandetanib in     combination with standard radiation therapy, 131I-mIBG, in patients with advanced     phaeochromocytoma (phaeo) and paraganglioma (PG) by assessing the safety and tolerability of     the combination treatment.   "
102704|NCT01941836|"     The purpose of this research study is to see how ETC-1002 is tolerated in the body, to     measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level     of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and     urine in patients with elevated LDL-cholesterol with or without statin intolerance.   "
102705|NCT01941823|"     Carnitine is essential for the transport of fatty acids into the mitochondria and energy     production in different muscles, including the myocardium. It is also needed to protect     myocyte cell membranes from oxidative damage by removing excess acyl carnitine groups.     Patients receiving chronic intermittent hemodialysis (HD) are known to be at increased risk     for carnitine deficiency as a result of its removal during the dialysis procedure, lack of     endogenous synthesis by the kidney, and inadequate dietary intake. The carnitine status of     children undergoing continuous renal replacement therapy (CRRT) has not been studied.     Children undergoing CRRT in the intensive care unit (ICU) setting may be at increased risk     for carnitine deficiency due to its continuous removal, lack of carnitine production by the     kidney, and absence of carnitine intake (as majority of these children can not eat and there     is no carnitine added to total parenteral nutrition (TPN). Carnitine deficiency may increase     the risk of cardiac dysfunction in critically ill children. This is the first study to     examine carnitine status in children undergoing CRRT. Standard echo as well as more sensitive     speckle tracking echo will be used to evaluate the effect of carnitine deficiency on     myocardial function.   "
102706|NCT01941810|"     This pilot phase II trial studies how well bovine lactoferrin supplement works in improving     taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help     improve the ability to taste food in patients who are receiving chemotherapy.   "
102707|NCT01941797|"     This is a pilot study. The investigators hypothesize that the peri-implant soft tissue     response to de novo plaque accumulation is similar to that of normal gingival tissue in the     same subjects.      The investigators propose to conduct a controlled clinical trial to evaluate peri-implant     soft tissue response to de novo plaque accumulation in comparison to the response of gingival     tissue in the same subjects   "
102708|NCT01941784|"     This pilot clinical trial studies a health education intervention in reducing weight gain in     patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health     education program may reduce weight gain and improve quality of life in patients undergoing     chemotherapy for breast cancer.   "
102709|NCT01941771|"     The study hypothesis is that metronomic treatment is more efficient than standard treatment.   "
102710|NCT01941758|"     This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune     response patients with central nervous system tumors. Studying samples of blood in the     laboratory from patients receiving trivalent influenza vaccine may help doctors learn more     about the effects of trivalent influenza vaccine on cells. It may also help doctors     understand how well patients respond to treatment.   "
102723|NCT01941589|"     The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and     recommended by professional societies. However, there are no data investigating whether the     addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic     corticosteroids is superior to corticosteroids alone in patients with moderate-severe active     UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue),     on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to     compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the     treatment of moderate-severe UC exacerbation.   "
102724|NCT01941576|"     The purpose of this study is to determine the effects of rhRNP on urine output and     hemodynamics following corrective repair of Tetralogy Of Fallot.   "
102725|NCT01941563|"     The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in     patients with lumbar disc herniation.   "
102726|NCT01941550|"     This study is aimed at evaluating the efficacy regarding the response rate and     metastasis-free survival time of cabazitaxel as a neoadjuvant treatment in patients with high     risk prostate cancer.   "
124227|NCT01659892|"     The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet     under fed conditions   "
102711|NCT01941745|"     Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result     of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical     ventilation and infection. These conditions initiate an inflammatory response characterized     by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the     development of significant acute and chronic lung injury.      The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10     is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is     the most abundant protein in the mucosal fluids in normal healthy lungs.      The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and     anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated     premature infants receiving positive pressure ventilation for treatment of respiratory     distress syndrome (RDS) to prevent long term respiratory complications referred to as     bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM;     asthma, cough, wheezing, multiple respiratory infections).      CC10 regulates inflammatory responses and protects the structural integrity of pulmonary     tissue while preserving pulmonary mechanical function during various insults (eg. viral     infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties     suggest that administration of rhCC10 may help to facilitate development of normal airway     epithelia and prevent the inflammation that leads to CRM in these infants.      This study is funded by the FDA Office of Orphan Product Development (OOPD).   "
102712|NCT01941732|"     Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile     dysfunction. A number of patients have reported that when they take Sildenafil, their need of     anti-PD medication is reduced.      We hypotheses that sildenafil increases brain blood flow and hence improves the function of     specific brain regions, improving motor function.      Motor function and cerebral blood flow of 8 patients will be tested before and after     Sildenafil intake and before and after anti-PD medication.   "
102713|NCT01941719|"     The purpose of this study is to examine the effectiveness of a novel patient education     strategy, compared to a standard diabetic foot education. The proposed diabetic foot care     education uses personal computer-animated plantar pressure data to educate patients on why     and how they should care for their feet.   "
102714|NCT01941706|"     Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed     to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were     demonstrated to be effective in treating depression among people with epilepsy in Georgia.     This project will assess whether the materials are also effective for preventing depression     among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas,     and Washington.   "
102715|NCT01941693|"     There is a high rate of psychological comorbidity in people suffering from alcohol     dependence. There is a need for an effective integrated treatment for alcohol dependence and     comorbid anxiety or depression. This study will test the efficacy of a novel integrated     intervention for comorbid alcohol dependence and anxiety or mood disorder.   "
102716|NCT01941680|"     Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and     Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than     65 years old, an allogeneic donor is searching out. Patients included at relapse and with     lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed     during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria)     receive allogeneic transplant. Patient follow-up is planned for 3 years old   "
102717|NCT01941667|"     The investigators want to determine if additional, increased contact with infants and     families discharged to home after cardiac surgery improves infant and parent outcomes as     compared to usual care.   "
102718|NCT01941654|"     To determine the efficacy of preemptive local ablative therapy in NSCLC patients with     activating EGFR mutation who have oligometastatic residual metabolic-active disease after     first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.   "
102719|NCT01941641|"     Objective tumour response rate to FOLFOXIRI to pre-operative therapy.   "
102720|NCT01941628|"     Cesarean delivery under general anesthesia is one of few only surgical procedures, where the     most important factor of safety is the speed of the surgery, as a newborn adaptation strongly     depends on a time between induction to the general anesthesia (and administration of     anesthetics) and pennywort ligation. The shortest possible interval is essential for the     amount of anesthetics crossing placenta into the fetal circulation.      The primary objective:      To compare surgical conditions for fetus delivery in Cesarean section under general     anesthesia with deep neuromuscular blockade versus standard procedure with succinylcholine.      The primary safety objective:      To compare influence of different levels of neuromuscular blockade and surgical conditions on     newborn adaptation after the Cesarean delivery.      The secondary objectives:      To compare influence of deep versus no/shallow muscle blockade during the entire Cesarean     section on surgical conditions for suture of the uterus and the abdominal wall with attention     to blood loss, time of surgery and surgical complications.      To describe pharmacodynamics and pharmacokinetics of deep neuromuscular blockade by     rocuronium over the course of Cesarean section and its reversal by sugammadex at the end of     procedure.      Clinical hypotheses:      The use of deep muscle blockade in Cesarean section under general anesthesia, including the     period of fetus delivery, compare to the standard recommended practice with succinylcholine,     will improve the surgical conditions and allow faster and easier delivery of the fetus with     positive effect on its postnatal adaptation. Faster delivery will reduce an incision to     delivery interval with decrease of time between anesthetics administration and delivery. This     will reduce the amount of anesthetics crossing the placenta to the fetal circulation. Both,     reduced amount of anesthetics and reduced incision to delivery interval itself will improve a     newborn adaptation after Cesarean delivery.      Deep neuromuscular blockade will also improve surgical conditions for the whole surgery, when     no or shallow only neuromuscular blockade is routinely used. We assume that deep     neuromuscular blockade during the entire surgery will create better surgical conditions for     faster and easier uterus suture and the rest of surgery and thus reduce perioperative blood     loss and incidence of surgical complications.   "
102721|NCT01941615|"     Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the     multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in     healthy premenopausal female volunteers.   "
102722|NCT01941602|"     The aim of the study is to compare different strategies for prevention of venous     thromboembolism related to intracranial meningioma surgery. The investigators identified     three hospitals where two have a very restrictive approach with respect to anticoagulant     therapy while at the third hospital the use of anticoagulation the day before surgery was     initiated as routine prophylaxis.      Based on this natural experiment it will be explored whether the use of anticoagulant     prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with     increased risk of postoperative hemorrhage as compared to the 2 cohorts where this     intervention were absent.   "
102755|NCT01941173|"     This pilot clinical trial studies short-infusion ziv-aflibercept in treating patients with     metastatic colorectal cancer receiving combination chemotherapy. Ziv-aflibercept may stop the     growth of colorectal cancer by blocking blood flow to the tumor. Giving the drug over a     shorter infusion time may result in improved efficiency and patient satisfaction.   "
102727|NCT01941537|"     Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most     aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of adults     and up to 25% among children. AD has a complex pathogenesis, characterized by: 1) immune     activation with increased numbers of T-cells, dendritic cells (DCs), and increased expression     of inflammatory molecules 2) marked epidermal hyperplasia in chronic diseased skin, and 3)     defective barrier function with increased trans-epidermal water loss (TEWL) and decreased     lipids, reflecting underlying alterations in keratinocyte differentiation. AD is     predominantly a Th2 (IL-4, IL-13, and IL-31) disease, and recently was also found to be a     T22 (IL-22) polarized disease.      ILV-094 is an anti IL-22 antibody and therefore should reverse the immune activation of AD.     This study is being done to assess the safety, tolerability, clinical efficacy, and mechanism     of action of ILV-094 in patients with AD.   "
102728|NCT01941524|"     The purpose of the study is to determine whether there are differences in bioelectrical     function (measured by amplitude integrated electroencephalography) and brain oxygenation     (measured by near infrared spectroscopy) while and after instillation of two different     surfactant preparations.   "
102729|NCT01941511|"     This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of     GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug     development.   "
102730|NCT01941498|"     The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using     the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).   "
102731|NCT01941485|"     The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond     laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT)     anterior segment corneal measurements compared to pre-operative flap thickness target.   "
102732|NCT01941472|"     Fluid challenge is often carried out in critical ill patients. Its responsiveness usually     requires invasive monitoring. To use non-invasive methods is very tempting. Investigators     hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations     provide feasible estimation on fluid responsiveness in critical ill patients.   "
102733|NCT01941459|"     Thru the last 20 years it has been a discussion witch solution that gives the best myocardial     protection during cardiac arrest by heart operations.        -  It has been a tendency that a blood based cardioplegia gives a better protection bye          long ischemic times but it has not been possible too conclude in this matter.        -  The investigators have two groups of cardioplegia, the blood based and, the crystalloid          based cardioplegia.        -  It has been done a lot of studies to see what kind of cardioplegia that gives the best          myocardial protection. Different temperature, different amount and content, retrograde          or antegrade or both, contentiously and further on have been tested without a clear          conclusion.        -  The investigators decided to make a study with a cohort of patients as homogenous as          possible with a cross clamp time around 70 min.        -  Adult patients' with a severe aortic stenoses without any other significant heart          disease was included in our prospective randomised study.        -  Patients with additional significant coronary artery disease (≥ 50% stenoses) were          excluded from the study.        -  The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the          myocardial damage.   "
102734|NCT01941446|"     This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way     crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through     3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4     nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a     minimum of a 14 day washout between treatments.   "
102735|NCT01941433|"     The purpose of this study is to determine whether an online patient passport tool called the     Arthritis Health Journal can assist people with rheumatoid arthritis in managing their     disease.   "
102736|NCT01941420|"     The investigators decided to make a study with a cohort of patients as homogenous as possible     with a cross clamp time around 70 min. Adult patients with a severe aortic stenoses without     any other significant heart disease was included in our prospective randomised study. This     group of patients was chosen for two reasons. First, these patients have left ventricular     hypertrophy making the myocardium vulnerable to ischemia, secondly the investigators wanted     to avoid the possible confounding effect of ischemia found in patients with variable degrees     of coronary artery disease. Therefore, patients with additional significant coronary artery     disease (≥ 50% stenoses) were excluded from the study.   "
102737|NCT01941407|"     The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase     III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra     toxicities.      It could be interesting to explore the combination of bev + eribulin in first line metastatic     breast cancer.   "
102738|NCT01941394|"     Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT)     for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and     treatment.   "
102739|NCT01941381|"     Due to recent efforts to decrease antibiotic overuse, and reports of high rates of     spontaneous resolution for clinically diagnosed Acute Otitis Media(AOM), most physicians now     wait 48-72 hours before starting antibiotics for common ear infections. The investigators are     interested to see if those patients with documented middle ear effusions, as determined by     tympanometry, have higher rates of eventual antibiotic usage than those with normal     tympanometry results. If there is a significant disparity between those with a positive     tympanogram and those without the investigators may be able to identify a group that will     benefit from antibiotics and a group that would not need treatment.   "
102756|NCT01941160|"     The objectives of this study are to evaluate stool consistency and stool frequency during and     up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg     BID.   "
102774|NCT01940926|"     This is an open-label positron emission tomography/computed tomography ( PET/CT) study to     investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in     rheumatoid arthritis (RA) patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤ 40 µg     BNOTA-PRGD2) will be intravenously injected into patients with RA. Visual and     semiquantitative method will be used to assess the PET/CT images. Whole body 18F-FDG PET/CT     will be performed for comparison.   "
102740|NCT01941368|"     Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and     free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical     power, anaerobic working capacity and neuromuscular economy in a population of endurance     trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on changes in     skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length) and muscle     quality (MQ=echo intensity) in the rectus femoris and vastus lateralis.      Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to     participate in this study. Subject will be randomized to one of three groups: a control group     (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite HMB and     perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing. They will     then be asked to continue their normal exercise routine for 4 weeks and will undergo     post-testing after this time period.      Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours     prior to the start of the training period. The same testing protocols will be repeated at the     end of the 4-week training period. Testing protocols include performance testing (VO2peak,     lactate threshold, critical power, anaerobic working capacity and neuromuscular economy) and     anthropometric measures (physiological cross-sectional area and muscle quality). The training     protocol for individuals in the experimental groups will consist of 4-weeks of high intensity     interval training with three sessions per week on an electronically braked cycle ergometer.     Individual work -loads will be calculated based on the outcomes from each participant's     preliminary testing.   "
102741|NCT01941355|"     Patients undergoing coronary artery bypass graft surgery often experience a range of problems     and symptoms related to the procedure and the underlying heart disease. These problems     include anxiety and depressive symptoms, immobility issues, complications such as wound     seeping, neck and shoulder pains, interrupted and insufficient sleep. Over the last 2     decades, cardiac rehabilitation has become recognized as a significant component in the     continuum of care for persons with cardiovascular disease. Furthermore, cardiac     rehabilitation has undergone a significant evolution moving from a focused exercise     intervention to a comprehensive disease management program. In Guidelines for Coronary Artery     Bypass Graft Surgery cardiac rehabilitation is described to include early ambulation during     hospitalisation, and outpatient prescriptive exercise training beginning 6-8 weeks following     surgery. Our hypothesis is that physical exercise with moderate intensity and a     psycho-educative component as a part of cardiac rehabilitation can begin in early     postoperatively during hospitalising. Results from studies on phase 1 rehabilitation in     coronary artery bypass graft surgery patients are promising. However, no randomised trials     have been conducted, and evidence is therefore lacking.      The objective of this pilot trial is to investigate the effect of a phase 1 comprehensive     cardiac rehabilitation programme consisting of a psycho-educative component, an     exercise-training component including pulmonary training, cycling, neck and shoulder     exercises, these in combination plus treatment as usual and treatment as usual in patients     who undergo coronary artery bypass grafting.      SheppHeartCABG is an investigator-initiated 2 x 2 factorial randomised clinical pilot trial     with blinded outcome assessment. Recruitment from one site with 1:1:1:1 central randomisation     to phase 1 rehabilitation; 1) exercise-training plus usual care, 2) psycho-educative plus     usual care 3) exercise-training and psycho-educative plus usual, 4) usual care alone.   "
102742|NCT01941342|"     The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD)     which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by     observing the prevalence of drainage and surgery related complications, hospital stay,     medical cost and life quality compared to surgery alone. It is anticipated that PBD can     reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.   "
102743|NCT01941329|"     This study is a prospective, randomized, multicentre, open label study that intents to     compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus     Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the     neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a     12-month treatment period.      One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of     the leading causes of visual impairment in working age in industrialized countries. Longer     diabetes duration and poor glycaemic and blood pressure control are strongly associated with     Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and     6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93     million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic     Retinopathy.      It has been shown that treatment with repeated injections of ranibizumab can improve visual     acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains     unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete     and, therefore, efforts should be done to understand and characterize patients' eyes response     to combined treatments.      Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e.     Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV     injections of ranibizumab since it is expected that anti-vascular endothelial growth factor     (VEGF) treatment with ITV injections will increase the rate of success of Panretinal     Photocoagulation in regression of neovascularization with improved final visual acuity.   "
102744|NCT01941316|"     The purpose of this study is to determine a well-tolerated dose of Carfilzomib in combination     with Irinotecan (Phase 1b portion of the study) in subjects with relapsed small and non-small     cell lung cancer or other irinotecan-sensitive cancers and to assess the 6 month survival of     relapsed small cell lung cancer patients treated with this combination therapy. **The Phase     1b portion of the study is now complete**.      Phase 2 portion of the study. The safest, maximally tolerated dose established as established     in Phase 1 for Phase 2 is as follows -- Carfilzomib will be provided at 20/36 mg/m2 with     Irinotecan dosed at 125 mg/m2. The purpose of the Phase 2 portion of the study is to assess 6     month survival of relapsed small cell lung cancer ins subjects treated with this combination     therapy.   "
102745|NCT01941303|"     As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent     non-small cell lung cancer. Even after primary radical treatment to high doses,     re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again     using high doses of radiation.      Publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and     toxicity for patients treated in MAASTRO are unknown at present. This study will provide     knowledge on benefit and risks of such a therapeutic approach.   "
102771|NCT01940965|"     Primary Objective:      The primary objective of this study is to assess the overall safety of lixisenatide once     daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in     patients with type 2 diabetes in Japan.      Secondary Objective:      To assess the effects of lixisenatide in combination with background oral antidiabetic drug     (OAD) on:        -  HbA1c;        -  Fasting plasma glucose;        -  Body weight.   "
124357|NCT01657981|"     The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with     a radio labeled drinking solution.   "
102746|NCT01941290|"     For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to     long-term complications range from rather immediate elastic recoil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from     30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents     (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical     restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still     occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug     Eluting Stents (DES) significantly improved on the principle of BMS by adding an     antiproliferative drug (directly immobilized on the stent surface or released from a polymer     matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the     incidence of restenosis and resulted in a better safety profile as compared to BMS with     systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease.      An interesting group of analysis resulted to be diabetic patients. It has been concluded that     the incidence of both nonocclusive and occlusive restenosis is higher in diabetic subjects     after stenting as judged from comparison with historical control subjects. Results implicate     accelerated restenosis as both a consequence of diabetes and a cause for increased mortality     after PCI in diabetic patient.      Therefore this observational registry has been designed for the clinical evaluation of the     Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary     revascularization with Drug Eluting Stents (DES). Results will contribute to the collection     of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent     System in daily clinical practice.   "
102747|NCT01941277|"     The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in     subjects who do not routinely exercise and who are at risk of developing diabetes     (prediabetes).      It is estimated that approximately 30-90 people will participate in this study at three study     sites in the United States and United Kingdom.   "
102748|NCT01941264|"     Malaria is a common disease in Africa and a major health problem. Pregnant women are also at     risk of malaria. Malaria in pregnancy is life threatening to both the mother and the baby she     is carrying. It can result in the destruction of the mother's blood and in babies with a     lower birth weight than normal, making them less healthy in their first years of life. These     risks are even higher in women having their first pregnancy.      When a woman is pregnant she should go to the Antenatal clinic (ANC) for care. Usually the     ANC health staff gives the woman intermittent preventable treatment (IPTp-SP) against     malaria. This drug helps protect the woman against getting malaria. Each pregnant woman     should receive at least 2 doses of this drug during their pregnancy; thus, they should go the     ANC at least 2 times during their pregnancy. However, many women still do not go often to the     ANC for health care during their pregnancy.      This study would like to see whether community health workers (CHW) can work with pregnant     women to encourage them to attend ANC more often. Also, the CHW will test a pregnant woman     every month for malaria with a rapid test. If a woman has malaria, the CHW will treat her in     her home instead of the woman having to go a health clinic for treatment. The woman will be     treated with a different drug than the drug that is given at the ANC visits. Our hypothesis     is that this will improve the care and management of malaria during pregnancy and this will     improve the health of women and their newborns. To see whether this strategy improved the     health of women and their newborns, we will take a small piece of the placenta at delivery to     test for malaria and we will weigh the baby. We will test this strategy in multiple     communities. We will compare this to pregnant women in communities where this strategy was     not followed, thus where pregnant women received standard care.      Participants will be pregnant women. There are no direct benefits for participating in the     study, except the outcome of our research question that is possible health benefits in the     intervention group. The drugs involved are tested safe in pregnant women from second     trimester on.   "
102749|NCT01941251|"     Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on auditory     hallucinations as well as negative symptoms of schizophrenia. However, previous studies have     reported mixed or negative results. Majority of the repetitive transcranial magnetic     stimulation (rTMS) studies to date has set the target of cortical stimulation based on scalp     site. Recently introduced method, navigated transcranial magnetic stimulation (nTMS)     integrates the individual MRI data, and thus allows more precise targeting on brain cortical     regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced alpha     band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG guided     TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising     results.      The aim of the study is to investigate the efficacy of navigated individualized αTMS in     treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV     schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The     patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex     (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and Negative     Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test battery at     baseline, 5 days after and 3 months after treatment. Serum and plasma levels of brain derived     neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.   "
102750|NCT01941238|"     Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump     offers the advantage of flexibility and precision to administering insulin and has been     proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there     are extremely limited studies on the difference between insulin pump compared to MDI on the     incidence of hypoglycemia and other acute complications during fasting Ramadan      The investigators hypothesized that insulin pump would be associated with less hypoglycemic     events during fasting Ramadan compared to MDI without deterioration in glycemic control.     Results of this study are descriptive but will fill a current gap in knowledge and may     contribute to development of future guidelines for the management of type1DM during Ramadan.   "
102751|NCT01941225|"     The purpose of this study is to investigate the role of the pulmonary vasculature in the     development and progression of chronic obstructive pulmonary disease (COPD). To accomplish     this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in     oxidative stress and lung volumes during exercise will be measured.   "
102752|NCT01941212|"     To evaluate the effect of musical therapy before and after gynecological surgeries on pain     relief following surgery.      The hypothesis is that musical therapy is effective in pain relief following surgical     procedures.   "
102753|NCT01941199|"     This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to     investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and     Metformin IR 1000 mg after oral administration in healthy male volunteers.   "
102754|NCT01941186|"     This is a randomized controlled trial aimed at assessing the effectiveness of a patient     decision aid (PDA) and text message reminder in promoting early intervention referral     completion when infants and toddlers are identified with a developmental concern in the     pediatric medical home. Subjects will be randomized to one of two study arms- (1)     intervention (2) control condition. Subjects in the intervention arm will watch a video PDA     and will receive a text message reminder approximately 7 to 14 business days after enrollment     if they agree to the early intervention referral.   "
123317|NCT01671865|"     The purpose of this research study is to identify and study changes in muscle in people with     facioscapulohumeral muscular dystrophy using magnetic resonance imaging and spectroscopy.   "
102757|NCT01941147|"     There is great interest in the development of novel therapies for acute ischemic stroke     because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests     that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for     acute ischemic stroke therapy because of their effects on the main mechanisms of brain     ischemic damage and regeneration.The main purpose of this open label, one arm, dose     escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective     tool to promote recovery in acute ischemic stroke patients Nine patients will be treated     daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose     cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at     increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be     evaluated by the incidence of adverse events and mortality throughout the stimulation period     and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical     and radiological scores.   "
102758|NCT01941134|"     This study will attempt to determine whether having gastric bypass surgery changes the way     that the gut absorbs hormones from birth control pills. It is believed that, because gastric     bypass surgery causes malabsorption of nutrients and some medications, the levels of birth     control hormones after the surgery will be lower than in women before they have the surgery.     The investigators will ask several women to take a pack of birth control pills before having     bypass surgery, and then another pack several months after surgery. The investigators will     measure hormone levels in the blood. The investigators will also measure outcomes that may     tell us how well the birth control pills are working, such as ultrasounds of the uterus and     ovaries, and examination of the cervix.   "
102759|NCT01941121|"     This is a CCTG sponsored project to determine if those recently screened for HIV would accept     assistance to be linked into appropriate health services. After receiving their HIV results,     high-risk individuals who test negative will have an option to be linked into a study that     offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an     option to be linked into care.      If they accept, tested individuals will be in contact with an ALERT specialist that will help     facilitate their linkage. The study's primary analysis will analyze how many HIV screened     individuals accept the ALERT specialist assistance.   "
102760|NCT01941108|"     The purpose of the mPeer2Peer Study (mP2P) is to see if we can use a smartphone and a Peer     Navigator (PN) to improve medical care for HIV-positive people who have been out of HIV care     for over one year.   "
102761|NCT01941095|"     This multicenter, open-label, single arm study will evaluate the safety and efficacy of     subcutaneous (SC) tocilizumab as monotherapy or in combination with methotrexate or other     non-biologic DMARDs in participants with active rheumatoid arthritis who are either naïve to     or have an inadequate response to prior non-biologic or/and biologic DMARDs. The anticipated     time on study treatment is 52 weeks. Those participants who will complete the 60-week study     period and have achieved Disease Activity Score (DAS) 28 remission or a good European League     Against Rheumatism (EULAR) response at 52 weeks will be eligible to enter the extension phase     until tocilizumab is commercially available and reimbursed in Greece.   "
102762|NCT01941082|"     This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in     patients with wet age-related macular degeneration.   "
102763|NCT01941069|"     The overall purpose of this project is to determine whether school personnel implementing a     two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention)     program for typically developing children as well as children with, or at risk for,     externalizing or anxiety disorders can implement the components of the program with the same     level of fidelity, integrity and clinical effectiveness when they receive a low level of     support (consultation) from their coaches and supervisors as they can with a high level of     support (consultation and coaching).   "
102764|NCT01941056|"     This phase I trial studies the side effects and the best dose of vaccine therapy in healthy     volunteers with or without previous exposure to cytomegalovirus. Vaccines made from a     gene-modified virus may help the body build an immune response and may help prevent     cytomegalovirus infection.   "
102765|NCT01941043|"     The current study will evaluate the antidepressant effect of CERC-301 during 28 days of     treatment in subjects with MDD who are currently experiencing a severe depressive episode     despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine     reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that     would benefit most from rapid onset, those with recent active suicidal ideation, but not a     risk to themselves or others and are deemed appropriate for an out-patient study with careful     safety surveillance. This will allow the study to focus on the antidepressant effects of     CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary     endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a     secondary endpoint.   "
102766|NCT01941030|"     CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger,     statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia     (CLI).   "
102767|NCT01941017|"     Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and     patients with tubal factor infertility   "
102768|NCT01941004|"     To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China   "
102769|NCT01940991|"     This study will confirm the efficacy and safety of a single topical administration of     botulinum toxin type A compared to placebo control for the treatment of moderate to severe     crow's feet lines   "
102770|NCT01940978|"     Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines     such as methylphenidate. Lack of sufficient food intake has been shown to have negative     effects on weight and height as well as learning and memory.      There is no current treatment to prevent this loss of appetite except discontinuation or     reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the     return of ADHD symptoms.      The purpose of this study is to compare the effects, good and/or bad, of two doses of a drug,     cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite suppression     associated with methylphenidate.   "
123833|NCT01665118|"     The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio     Frequency) device in the reduction of thigh circumference.   "
102783|NCT01940809|"     This randomized phase I trial studies the side effects and best way to give ipilimumab with     or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that     has spread to other parts of the body (metastatic) or cannot be removed by surgery.     Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of     cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. It is not yet known whether     ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating     melanoma.   "
102784|NCT01940796|"     This research study is trying to determine the safest dose of Brentuximab Vedotin that can be     given to patients with chronic GVHD and see if chronic GVHD improves.   "
102785|NCT01940783|"     One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI)     recipients was reported to be the placement of the electrode array in the scala tympani. It     seems that the correct placement of the electrode initially into the scala tympani and     subsequent avoidance of dislocation into the scala vestibuli as the insertion progresses, is     a key factor in achieving good speech perception outcomes. Another important aspect related     to the performance is the achievement of consistent electrical coverage with the electrode.     Data reported for electrodes of different manufacturers give depths ranging from 240 - 600     degrees showing the considerable variation across subjects. The HiFocus mid scala electrode     was developed to cover one and a quarter turn and with the pre-curved design to be less     susceptible to variations in individual cochlea dimensions and insertion techniques. A     further mechanical feature of the pre-curved design is the avoidance of forces against the     cochlear lateral wall and associated lower susceptibility of the electrode for moving out of     the cochlea following insertion. Recently, a cone beam CT (CBCT) technique is being explored     in the field of ENT with the potential to overcome some of the issues associated with the     conventional CT techniques such as scattering, radiation and low isometric resolution. Images     with comparable details to those of e.g. micro CTs are possible with much lower radiation     dose. Modern imaging software i.e. 3D Slicer (www.slicer.org) may be used for 3D     reconstruction, post processing and Brainsfit for registration. Registration is the alignment     of two scans in the same coordinate system. This enables the identification of differences     between two images recorded at time x and y. Once accurately superimposed any difference     between the two images may be identified with an accuracy of 0.2 mm. Using these methods, one     can assess the stability and the position of the electrode in the cochlea.      Objective: The primary objectives of this study are to evaluate the feasibility of using cone     beam CT technique in combination with (high resolution) MRI to identify electrode movements     following cochlear implant surgery and identify the inter-scalar position of the HFms     electrode. The secondary objective is to quantify the average insertion depth and variations     of the HFms electrode   "
102786|NCT01940770|"     To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with     type 2 diabetes mellitus under actual drug use.   "
102787|NCT01940757|"     An experimental hookworm infection model is being developed to provide early proof-of-concept     that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible     and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults     with a candidate hookworm vaccine, followed by challenging them with the investigational     product, Necator americanus Larval Inoculum to assess the effect of vaccination on infection.     The first proposed study will be a feasibility study that will consist of administering     different doses of the Necator americanus Larval Inoculum to healthy adult volunteers to     determine the optimal dose (i.e., number of infectious larvae) that is safe, well-tolerated     and results in consistent infection.   "
102788|NCT01940744|"     This study is designed to compare the outcomes of two types of manual therapy techniques on     patients with low back pain. Both immediate- and long-term outcomes will be examined. The     investigators hypothesize there will be no differences between the two applied treatment     techniques in immediate and longer-term assessments.   "
102789|NCT01940731|"     1. To evaluate the clinical and microbiological efficacy and safety of Colistimethate          sodium Injection Vial to treat adults with hospital-acquired pneumonia .        2. To Learn the pharmacokinetic characteristics of continuous intravenous infusion of          Colistimethate sodium.   "
102790|NCT01940718|"     It is believed that when androgen (testosterone) levels are below normal there is a     disturbance of normal bodily functioning that is associated with priapism in some men.     Conversely, it is believed that testosterone replacement will improve the condition of     priapism when the testosterone levels are brought to normal. In turn, this will also improve     psychological well being in men with sickle cell disease (SCD).   "
102791|NCT01940705|"     Hearing loss is the second most prevalent service-connected disability among Veterans.     Hearing aids are the most common technological intervention for hearing loss. The VA,     therefore, spends a considerable amount of money on them. Despite these expenditures, there     are some Veterans who do not use their hearing aids successfully. Research has demonstrated     that this inconsistent use may be related to a patient's inability to effectively take care     of, and use, hearing aids. The proposed investigation will compare the effectiveness of three     different tools for enhancing the educational efforts (hearing-aid orientation) typically     provided by clinical audiologists when dispensing hearing aids. Each of these educational     tools were developed using established methods for improving patient-provider communication.     The investigators hypothesize that the use of these tools will result in better hearing-aid     outcomes for Veteran patients than using the current standard-of-care procedures.   "
102792|NCT01940692|"     Through a randomized controlled trial, we will compare the intravenous administration of     tranexamic acid with the intra-articular application after a total hip arthroplasty through     direct anterior approach.        -  RCT, prospective study        -  Academic-monocentric study        -  Clinical outcome measurements The postoperative blood loss will be the primary outcome.          Secondary outcomes are             1. The rate of perioperative and postoperative blood transfusion             2. The number of blood units transfused             3. The length of hospital stay             4. Perioperative given intravenous isotonic fluid      The Null-hypothesis is that there is no significant difference in postoperative blood loss     between intra-articular and intravenous administration of TXA.   "
102816|NCT01940367|"     The purpose of this study is to determine whether transcutaneous sacral nerve stimulation     (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective     therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed     conventional therapy. Our primary hypothesis is that TENS therapy is a more effective     treatment option due to ease of use and improved subject compliance with this form of     therapy.   "
102819|NCT01940328|"     The purpose of this study is to evaluate the lung Doppler signals in left HF patients with     and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF     patients respectively), in comparison to a control group of subjects without CHF (non-CHF     controls), in order to determine the diagnostic value of this non-invasive method in CHF. If     this method will prove to be of diagnostic value, it could potentially be used to diagnose     and monitor CHF patients in both inpatient and outpatient settings.   "
102793|NCT01940679|"     Omega-3 fatty acids (n-3s), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid     (DHA), have anti-inflammatory properties and other documented beneficial health effects that     could warrant n-3 fortification of combat rations. However, military combat rations must meet     rigorous shelf-stability guidelines (e.g.,, 3 years at 80°F or 6 months at 100°F), which is     problematic for natural food sources of n-3s (e.g., oil and fish), which degrade when exposed     to high temperatures and prolonged shelf-storage. Encapsulation, e.g., coating freeze dried     n-3s with gelatin, can prevent this degradation, and Natick Soldier Research, Development and     Engineering Center's (NSRDEC) Combat Feeding Directorate used encapsulated n-3 technology to     produce n-3 enriched ration items that withstand environmental stressors and meet shelf-life     specifications for military rations. However, the bioavailability of the encapsulated n-3s in     these rations is unknown, particularly when they are incorporated into high-protein food     items and exposed to high temperatures and prolonged storage. In this randomized, cross-over     study, civilian and/or military personnel will be asked to consume: 1) a high protein food     item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 2)     a low-protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6     months at 100°F; 3) a high protein food item with encapsulated n-3s (600 mg) that was not     subjected to high-temperature and prolonged storage; and, 4) a low-protein food item with     encapsulated n-3s (600 mg) that was not subjected to high temperature and prolonged storage.     Serial blood sampling to measure acute changes in the circulating fatty acid profile will     occur in the hour before and 6 hours after consumption of each ration component. The only     known risks, which this study presents to participants, are those associated with venous     catheter placement. The results will help military ration developers determine the ration     components best suited for n-3 fortification.   "
102794|NCT01940666|"     STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone     [TT], androstenedione [A4], free androgen index [FAI], or dehydroepiandrosterone-sulfate     [DHEA-S]) present with an unfavorable metabolic and hormonal profile, appear to be more     insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with     excess free androgen index tend to be obese and face the highest metabolic syndrome risk,     adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT     group presents with a marginal IR risk, while the excess A4 group has the highest     antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S     group have a favorable association with IR.   "
102795|NCT01940653|"     Cryopreserved-thawed embryos are often replaced in an artificial cycle, in which the     endometrium is prepared by exogenous estrogen and progesterone with or without the use of     GnRH agonist downregulation. The correct duration for exposure to progesterone is still not     well established. To date, there are no prospective randomized trials available, comparing     different durations of progesterone supplementation before the date of transfer, with regard     to treatment outcome (Nawroth).      In this trial, the investigators want to determine the optimal duration of progesterone     supplementation: 3 or 5 days before embryo transfer.   "
102796|NCT01940640|"     To date, the investigations in the field of the supplementation with DHA in premature babies     have been focused on the study of neuronal and visual development, giving place to     contradictory and ambiguous results, because they did not consider in many cases important     aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and precise     studies have not been performed in the field of the oxidative damage, inflammation and bone     development in this population.      Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a     mother supplementation with high doses of DHA will increase proportionally the levels of this     fatty acid in her milk, fact that will allows the premature newborn child receive a major     dose of this fatty acid, and therefore this way, we will manage to improve the neuronal and     visual development and to take part on the inflammatory process, oxidative damage and its     evolution, together with the development or bone mass increase in the premature baby.      Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother     supplementation during the lactation with high doses of DHA on the development and wellness     of the premature newborn children. We try to deepen into the effect on the neuronal and     visual development and to study, for the first time, the effect on the oxidative damage, pro-     and antiinflammatory citoquines activity and bone metabolism in this group of newborn babies.   "
102797|NCT01940627|"     The General Aim of this study is to verify if a short term supplementation can modulate     diverse aspects related to the physical regular high intensity activity. To get this general     aim and following the criteria established by the EFSA Guides, this general aim will be     divided in specific or concrete aims, and will be studied by its specific analytical.      First Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term     (2 weeks) study can influence the physical performance, resitance , muscle function and     weakening: maintenance of normal muscle function, maintenance of endurance performance,     increase in endurance performance/capacity, reduction in the rated perceived exertion/effort     during exercise, increase in physical performance and maintenance of muscle mass and     piscological variables that the sportsman suffers before and after the high intensity     exercise.      Second Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short     term (2 weeks) study can influence the biochemical and haematological parameters in     sportsman.      Third Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term     (2 weeks) study can influence the oxidative stress asociated to a high intensity exercise.      Fourth Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short     term (2 weeks) study can influence the inflammatory signaling, the activity of diverse pro -     and anti-inflammatory citokines associated to high intensity exercise.   "
102798|NCT01940614|"     Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of     diabetes insipidus against the standard diagnostic test methods.   "
102799|NCT01940601|"     The primary objective of this study is to find the optimal dose of balugrastim by     characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of     balugrastim to filgrastim in children receiving chemotherapy.   "
102800|NCT01940588|"     Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated     with a neuropsychoanalytic paradigm.   "
102801|NCT01940575|"     - Study design:Multi-center, randomized, double-masked (Unblinded treating investigators),     intra-individual comparison clinical trial   "
102802|NCT01940562|"     Platelet recovery is significantly hampered following umbilical cord blood transplantation     (UCB). Thus, after UCB transplantations, patients are platelet transfusion-dependent for     prolong periods of time.      Eltrombopag is a thrombopoietin-receptor agonist that initiates thrombopoietin-receptor     signaling and thereby induces proliferation and maturation of megakaryocytes.      We will evaluate the safety and efficacy of eltrombopag for enhancing platelet engraftment in     pediatric patients undergoing cord blood transplantation.   "
123850|NCT01664897|"     The goal of this clinical research study is to learn if erlotinib can help to control AML.     The safety of this drug will also be studied.   "
102804|NCT01940536|"     The goal of this study is to determine if the use of tranexamic acid, a safe and effective     antifibrinolytic, in patients with intertrochanteric hip fractures will result in a reduction     in blood transfusion rates. Treatment will be administered pre-operatively as well as at the     time of surgical incision. The primary outcome will be need for blood transfusion. Secondary     outcomes will include calculated perioperative blood loss, length of stay, cost of inpatient     care, and rate of adverse events, including DVT, PE, infection, MI, cerebrovascular event,     need for re-hospitalization or re-operation and 30 day mortality.   "
102805|NCT01940523|"     The purpose of this study is to determine whether topical or intravenous administration of     tranexamic acid during unilateral total knee replacement is more effective at reducing     bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that     has been shown to reduce blood drain output and the need for blood transfusions in both its     topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that     IV and topical administration of tranexamic acid will be equally good at reducing the loss of     blood and the need for transfusion immediately following total knee replacement.   "
102806|NCT01940510|"     This single center, open-label, 3-period, fixed-sequence study will evaluate the effect of     multiple oral doses of rifampin on the pharmacokinetics of a single oral dose of RO5424802 in     healthy volunteers. Subjects will receive a single dose of RO5424802 on Days 1 and 17 and     rifampin daily from Days 8 to Day 20.   "
102807|NCT01940497|"     This non-randomized, multicenter, open-label study will assess the safety and efficacy of     subcutaneously administered trastuzumab in participants with early and locally advanced     HER2-positive breast cancer in two sequential cohorts. First 120 participants will be treated     with subcutaneous (SC) trastuzumab 600 milligrams (mg) vial (Cohort A) and the subsequent 120     participants will be treated with SC trastuzumab prefilled single use injection device (SID)     (Cohort B). Participants from each cohort will receive neoadjuvant or adjuvant chemotherapy     consisting of doxorubicin every 3 weeks (q3w) (1 cycle) for 4 cycles followed by paclitaxel     weekly or docetaxel every 3 weeks (q3w) in combination with SC trastuzumab (600 mg) q3w for 4     cycles and a further 14 cycles of SC trastuzumab (600 mg) q3w alone. All participants will be     followed up for 24 months after the last participant has received the last dose of study     treatment, or earlier in case of withdrawal from the study, loss to follow-up or death.   "
102808|NCT01940484|"     This observational study will evaluate the efficacy and use of Methoxy polyethylene     glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on     hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should     have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta     in advance and not related to the study. The therapy will be administered by the attendant     treating physician according to specifications in the package insert guidelines and to the     routine of the site.   "
102809|NCT01940471|"     The primary objective of this study is to compare the efficacy, safety, and tolerability of     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and     treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B     virus (HBV) infection.   "
102810|NCT01940445|"     At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type II-V will be enrolled in 2     clinical sites; each clinic will enroll at least 15 subjects.      Subjects should present visible wrinkles and/or elastosis requiring treatment.      Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general     skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75% of     the subjects.   "
102811|NCT01940432|"     This research is primarily to compare effectiveness of electroacupuncture and pelvic floor     muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress     urinary incontinence (SUI). The early clinical research is a randomized controlled trial     (RCT) with a small sample,consisting of two arms of electroacupuncture group and sham     electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks.     The result indicates that electroacupuncture is an optimal method for SUI. As a further     study, this research is a large sample multicenter trial with two parallel arms of     electroacupuncture group and pelvic floor muscle training group. The primary purpose is to     value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and     amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is     to evaluate safety of electroacupuncture therapy, and compare acceptance of     electroacupuncture treatment and pelvic floor muscle training.   "
102812|NCT01940419|"     In Denmark, 4400 women annually undergo hysterectomy on benign background (surgical removal     of the uterus). 10% of these women experience bleeding complications. The drug Tranexamic     Acid (Cyklokapron) has showed significant reduction of bleeding in relation to other types of     surgery. The hypothesis of this study is that Tranexamic Acid could also reduce the operative     bleeding associated with benign hysterectomy. The study will be carried out as a randomized,     placebo-controlled national multicenter trial   "
102813|NCT01940406|"     The current study is designed to test the hypothesis that targeted electrical stimulation     will result in upper limb tremor reduction in ET and PD patients.   "
102814|NCT01940393|"     The antihistamines with inhaled steroids are the cornerstone on the symptomatic therapy in     the management of patients with rhinitis and the first line of treatment in patients with     urticaria. Currently, the use of antihistamines has become popular due to its excellent     safety profile and clinical efficacy, however to the investigators knowledge, there are no     studies about the pharmacokinetic and pharmacodynamic effects of these drugs in patients of     tropical Latin America. The investigators main interest is to evaluate if skin test     inhibition correlates with the clinical effect of five anti-histamines.   "
102815|NCT01940380|"     Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a     deterioration of the bone architecture resulting in an increased risk of fracture,which is     directly related to the lack of estrogen and also associated with a variety of genetic and     acquired factors. Previous studies have found that POP molecular regulation mechanism of     kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.      This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and     healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the     kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.   "
102821|NCT01940302|"     Due to metabolic disorders and dietary restrictions, patients with diabetes may have     different degrees of malnutrition. The primary objective of this study is to investigate     whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve     metabolic parameters in patients with type 2 diabetes.   "
102822|NCT01940289|"     The primary aim is to examine whether there is a consistent range of pressure threshold     values for the asymptomatic foot.Previous studies established the inter/intra-clinician     reliability of pressure threshold measuring and have established a normative range of values     within the trunk and upper body. Since the establishment of these values, pressure threshold     testing has been used extensively in the head, neck, shoulders and spine as a clinical tool     and a research aid. There has been little work using it in the lower limb and there are no     guideline measurements for the clinician. By establishing a range of values for the foot,this     study will enable the clinician to employ pressure threshold measuring as a clinical tool to     easily and accurately identify areas of dysfunction and to objectively measure the     effectiveness of treatment. It will allow the clinician to establish a degree of improvement     or deterioration as it occurs in a patient's condition.      Secondary aims are to examine whether there is a correlation between visual analogue pain     scale (VAS) scores and algometric pressure threshold scores for subjects with forefoot pain.     This will help validate the tool for use in the foot. Since VAS is well documented and     validated, this study will examine whether there is a correlation between VAS and algometry     and whether there are gender or age differences in the range of measurements obtained. These     areas have been addressed in previous studies but results have been contradictory and     inconclusive and none of the previous studies focused on the foot.      An asymptomatic group of 384 subjects & symptomatic group of 160 subjects shall be selected     from those attending a podiatric clinic for routine foot care who meet the inclusion criteria     . Outcome me will be algometric pressure threshold testing, visual analogue pain scales and     foot function index questionnaires.   "
102823|NCT01940276|"     The primary goal is to prospectively estimate the median radiographic PFS of African American     and Caucasian men with mCRPC to abiraterone acetate and prednisone.   "
102824|NCT01940263|"     Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty     liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve     features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and     inflammation in rodents. The purpose of this study is to investigate whether purified     anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic     biomarkers in adults with features of NAFLD.   "
102825|NCT01940250|"     Hand foot and mouth disease (HFMD) is a common infectious disease caused by a number of     different viruses - a small proportion of children infected with a particular type of     enterovirus (EV71) develop neurological and systemic complications that may prove fatal. Very     large epidemics of EV71 related HFMD have occurred across Asia in recent years; in 2011, in     excess of 100,000 Vietnamese children were diagnosed with HFMD and 164 died.      In children with severe HFMD the particular part of the brain that regulates the heart, blood     circulation, and breathing responses can be affected. Management of this complication is very     difficult and we currently use an expensive drug (milrinone) that is hard to obtain and has     significant side effects, without having good evidence that it is effective.      Magnesium sulphate (Mg) is a cheap, readily available drug that has been used in other     diseases with similar complications, and we have preliminary data from a small case series     that suggests it might be a good treatment for HFMD patients with signs indicating this type     of brain involvement.      We think that early intervention with Mg, when signs of brain involvement are still     relatively mild, will control this problem better than waiting until it is well established     and giving milrinone as at present, and this in turn may prevent progression to severe     disease. The aims of the project are to evaluate the effects of Mg on hypertension, signs of     brain dysfunction, outcome (death or neurological sequelae), changes in a variety of blood     and urine components, and measures of cardiovascular function, in severe HFMD.      The study design is a randomized double-blind placebo-controlled clinical trial. Children on     the pediatric intensive care unit with a clinical diagnosis of hand, foot and mouth disease     will be eligible for enrolment if the blood pressure exceeds the internationally recognized     threshold for Stage 1 hypertension, they exhibit at least one other sign of brain stem     dysfunction, and there is written informed consent by a parent or guardian.      According to the randomization, patients will receive an initial loading dose followed by a     maintenance infusion, of either Mg or identical placebo for 72 hours; all staff involved in     patient care will remain unaware of the treatment allocation, but staff from another     department will monitor Mg blood levels to ensure safety and adequate dosing. A total of 190     patients (95 in each arm) will be recruited.   "
102826|NCT01940237|"     There is now overwhelming evidence documenting the efficacy of psychotherapy in the treatment     of depression in the general population. Surprisingly, however, given the high prevalence of     depression in cancer patients, there are very few studies on the efficacy of psychotherapy in     this population. Published studies of psychotherapy in cancer patients generally include     patients with high heterogeneity of psychiatric diagnosis and frequently include patients     without a psychiatric diagnosis, with the aim of preventing the appearance of a psychiatric     disorder. This heterogeneity complicates the interpretation of the efficacy and specificity     of these interventions. Specifically, the efficacy of psychotherapy for major depression in     patients with cancer is unknown.   "
102827|NCT01940224|"     The purpose of this study is to evaluate how effective is the preoperative administration of     pregabalin 300mg, to attenuate postoperative pain and opioids consumption after laparoscopic     colorectal surgery   "
102828|NCT01940198|"     This observational study will aim to determine long-term atazanavir experience in a high HIV     caseload primary care practice in Sydney, Australia.   "
102829|NCT01940185|"     A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter,     single-arm study, with patients as their own control to monitor the safety and efficacy of     the LINX implant procedure and device in a post-approval environment to supplement existing     safety and efficacy data.   "
102830|NCT01940172|"     This is a dose escalation study in female subjects with relapsed ovarian cancer (including     epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer).     Approximately 30 to 40 subjects will be administered a combination of conatumumab and     birinapant.      In the initial dose-escalation stage of the study, adult female subjects will receive     conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to     determine the MTD of birinapant when administered with a fixed dose of conatumumab.      In safety expansion stage, adult female subjects will receive conatumumab in combination with     birinapant at the MTD of the combination.   "
102831|NCT01940159|"     This is a single-center, randomized, single-blind, placebo-controlled, ascending single oral     dose study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles     of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.   "
102834|NCT01940120|"     Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6,     12, 18 and 24, months, and 3, 4 and 5 years. Concurrent Control (CC) group identified     retrospectively from the patients screened for the HRR who did not enroll; patient survival     determined at 12 months. NCT00209274 Intended use Percutaneous reduction of clinically     significant mitral regurgitation in symptomatic patients who are considered to be high risk     for operative mortality (high surgical risk).   "
103426|NCT01932333|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the     body does to the study medication) and pharmacodynamics (the study of the action or effects     the study medication has on the body) of single- and multiple, escalating oral doses of     JNJ-40411813.   "
102835|NCT01940107|"     To observe the effect of domiciliary physiotherapy on the upper limb applied during the     period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The     parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was     significant difference between the ipsilateral and contralateral limbs for flexion, abduction     and external rotation. There was no difference in perimetry in either group   "
102836|NCT01940094|"     This study is a multi-center randomized controlled trial to evaluate the effects of using     low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will     be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the     duration of the study (approximately six months) or until a study endpoint.   "
102837|NCT01940081|"     Rationale: Sudden cardiac death, mainly caused by ventricular arrhythmias (VA), is a major     cause of morbidity and mortality in non-ischemic cardiomyopathy (NICM). Therapies that     effectively prevent VA are lacking. Improved understanding of the substrate and mechanisms of     VA in NICM may allow more effective, individualized and substrate-based therapies to be     developed. In addition, risk stratification in NICM needs to be improved so that therapies     can be allocated more efficiently.      Objectives: 1) To improve our understanding of the underlying pro-arrhythmic substrate and     electrophysiologic mechanisms of VA in NICM, and to develop individualized treatment for VA     based on the identified substrate. 2) To improve risk stratification for VA and sudden     cardiac death in NICM based on substrate characteristics. 3) to evaluate disease progression     in NICM.      Hypothesis: Improved understanding of the substrate and mechanisms of VA in NICM may allow     more effective, individualized and substrate-based therapies to be developed.      Study design: A prospective cohort study.      Study population: The study population will consist of three groups (A, B and C): NICM     patients with documented VA, suspected VA or intermediate to high risk for VA (according to     established criteria) who are not referred for cardiac surgery (group A), NICM patients with     documented VA, suspected VA or a high risk for VA who are referred for cardiac surgery (group     B) and a control group consisting of patients without NICM who are referred for cardiac     surgery (group C).      Evaluation: All patients will be evaluated according to current standards for patients with     NICM. Evaluation will include 24h-Holter, echocardiography, coronary angiogram and     contrast-enhanced MRI (CE-MRI). If CE-MRI is performed in another hospital, additional     recordings will be performed in our hospital. Additionally, blood samples (arterial, cardiac     venous and peripheral venous) for collagen turnover markers will be taken from all patients.     123-iodine metaiodobenzylguanidine (123-I MIBG) imaging, electrophysiologic study and     endomyocardial biopsy will be performed in group A and B. Intra-operative biopsy will be     performed in group B and C.      Intervention: In group B, intra-operative mapping and cryo-ablation and postoperative     electrophysiologic study will be performed in patients with subepicardial late enhancement on     MRI or induced VA suspected for an subepicardial origin.      Main study parameters/endpoints: The main study parameters are extent, location and pattern     of fibrosis on imaging and in biopsy specimens. The main study endpoints are inducibility of     VA, type of induced VA, spontaneous VA and type of spontaneous VA.   "
102838|NCT01940068|"     The purpose of this study is to evaluate the impact of a new Amino-acid based formula on     allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to     extensively hydrolysed formulas;   "
102839|NCT01940055|"     Goal:      The development of a Treadmill Rehabilitation Platform (TRP) for task-orientated     rehabilitation that provides an adapted, blended approach among older adults with balance,     mobility, and cognitive impairments.      Study Objective:      Examine the feasibility and benefits of a novel dual-task intervention to address mobility     and cognitive decline with age using engaging interactive video games during treadmill     walking and recumbent cycling.This will include evaluation of the effects of two     interventions, one using treadmill walking and the second a recumbent cycle ergometer on        1. Core balance        2. Cardiac fitness, exercise endurance        3. Gaze control        4. Gait performance measure (walking stability and spatial-temporal gait parameters)        5. Specific executive cognitive function (processing speed, cognitive inhibition, working          memory)        6. Dual task function during treadmill walking      Hypothesis:        1. Dual-task exercise program will improve core balance and walking function to a greater          extent in the Treadmill walking group compared to recumbent cycle group.        2. Executive function will improve equally in both the treadmill walking and recumbent          cycle group.        3. Dual task exercise programs will have significant effect on gaze stability and cardiac          fitness equally for both the treadmill and recumbent cycling groups.   "
102840|NCT01940042|"     The investigators think that a simple maneuver at laparascopic surgery to reduce the     postoperative pain.   "
102841|NCT01940029|"     Neurosurgical ICU patients often receive hyperosmotic diuretics or cerebrospinal fluid (CSF)     drainage to decrease their intracranial pressure. It is also common to keep them under     normovolemia or mild hypervolemia status for stable cerebral perfusion pressure (CPP). These     patients have large urine output on average, and can decrease the reabsorption of specific     medicines by renal tubules. Besides, hypervolemia status might increase the volume of     distribution for hydrophilic medicines, and lower their serum concentration. Therefore, the     pharmacokinetic characteristics in this population may be different from general population,     which impacts the efficacy and toxicity of medicines with narrow therapeutic index.      Vancomycin is used mainly for MRSA (methicillin-resistant S. aureus) infection, and possesses     a significant place of therapy in treatment of neurosurgical patients' post-operation     infection. The serum concentration of vancomycin exhibits a clear relevance to its efficacy     and toxicity. From the investigators' preliminary research of the disposition of vancomycin     in neurosurgical ICU patients, the investigators found that their vancomycin serum     concentrations were lower than expected, which can be attributed to their 40% higher mean     vancomycin clearances than that of neurosurgical general ward patients. However, no definite     mechanism leading to this phenomenon was confirmed.      In this study, the investigators prospectively recruit a cohort of adult neurosurgical ICU     patients to validate the investigators' preliminary pharmacokinetic parameter models for     vancomycin. Furthermore, the investigators will also demonstrate the contribution of     different vancomycin elimination routes, renal and CSF drainage eliminating routs, to its     total clearance, and the relationship between vancomycin renal clearance and creatinine     clearance. Exclusion criteria include renal failure, unstable renal function, obesity, shock     status, third space fluid accumulation, burn and pregnancy. The models to validate are used     for empirical vancomycin dosage calculation. Therapeutic drug monitoring (TDM) is conducted     after vancomycin serum concentration achieves steady state, and the predicted and observed     serum concentration of vancomycin are compared to evaluate the consistency. On the other     hand, vancomycin excreted from urine and CSF drainage fluid would be calculated to see their     independent contribution for total vancomycin clearance. Meanwhile, the investigators try to     investigate the mechanism for renal elimination of vancomycin by its association to     creatinine clearance values calculated from urine creatinine concentration data.      Bringing all the information together, the investigators hope to provide helpful information     for the clinical pharmacokinetics of vancomycin therapy in neurosurgical patients, and to     optimize empirical vancomycin dosing and improve treatment success. Through this study, the     investigators also wish to understand the possible pharmacokinetic change of other medicines     in this population, and provide an important source of reference for clinical treatments.   "
102842|NCT01940016|"     This randomized clinical trial studies the feasibility of tailored physical activity     intervention that is administered using Interactive Voice Response technology and cell     phones. Interactive voice response and health coach support may motivate overweight     postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast     cancer.   "
102843|NCT01940003|"     The purpose of this study is to verify the efficacy of an aquatic physical exercise program     on GDM control and adverse maternal and fetal outcomes.   "
102844|NCT01939990|"     The purpose of this study is to demonstrate the safety and effectiveness of the study drug     Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary     Disease (COPD).   "
102848|NCT01939938|"     Our group has recently found that the choice of positive airway pressure mask can     significantly affect the pressure required to adequately treat sleep disordered breathing.     The goal of this study is to visualize the upper airway in the retropalatal and retroglossal     region while using both oronasal and nasal masks with CPAP in order to investigate     differences in upper airway dynamics that may occur between these two mask types.   "
102849|NCT01939925|"     The purpose of this randomised controlled trial is to compare a new standardised summary     format for presentation of synthesised evidence from systematic reviews for the public (a new     plain language summary format) to the current format used in Cochrane systematic reviews. The     study will evaluate if the new presentation improves understanding about the benefits and     harms of an intervention, if it improves the accessibility of the information, and if it is     preferred over other versions by the public over the current format.   "
102850|NCT01939912|"     The isolated response of the carotid bodies to local stimulation with adenosine has not been     researched in humans. There are single reports indicating that intravenous administration of     adenosine causes hyperventilation through activating the carotid bodies.      Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid     artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only     slightly influence the standard scheme of the procedure.   "
102851|NCT01939899|"     This is an open-label, multicenter, phase 2 study to evaluate the efficacy and safety of oral     IXAZOMIB in adult patients with follicular lymphoma (FL) that is relapsed and/or refractory     to prior treatment.   "
102852|NCT01939886|"     Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the     first line treatment policy in Kenya. AL is an efficacious drug that also has the capacity to     reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the     development of parasite resistance against AL. Clinical trials in Asia showed that     mefloquine-artesunate (MQ-AS) may be more efficacious than AL and may have a more pronounced     beneficial effect on post-treatment malaria transmission. MQ-AS is registered and used in     Kenya but there have been no reported direct comparisons of AL and MQ-AS with clinical and     transmission endpoints (i.e. adequately clearing parasites and preventing transmission to     mosquitoes).      Screening for molecular markers that are related to parasite susceptibility to ACT drugs and     to post-ACT treatment malaria transmission can assist strategies to prevent the development     and spread of ACT resistance.      In the current study, we compare AL and MQ-AS for the treatment of uncomplicated malaria. Our     endpoints are i) clinical efficacy, ii) post-treatment gametocytaemia by molecular     techniques.      In the current study, the investigators compare AL and MQ-AS for the treatment of     uncomplicated malaria. The investigators endpoints are      clinical efficacy post-treatment gametocytaemia by molecular techniques   "
102853|NCT01939873|"     The use of fundal pressure in management of the second stage of labor is controversial. The     aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the     second stage of labor and to examine the related neonatal and maternal outcomes.   "
102854|NCT01939860|"     Hypertension is a major health problem, however its control is unsatisfactory. One of the     reasons for such a high prevalence of this disease includes poor patient compliance to     treatment. Approximately 30 % of newly diagnosed hypertensive patients stop taking their     blood pressure medication by six months and 50% by 12 months.      The UK government is keen to encourage community pharmacists to play an active role in     participation of services that can improve patient adherence to their medications. The New     Medicines Service (NMS) and targeted Medicines Use Reviews (MUR) are established services     which fund community pharmacists to review and explain medicine use to patients, with     hypertension a common condition for which advice is given within these schemes. Within these     schemes, advice is verbal and unstructured, with no specific written information provided on     drugs or the disease being treated.      This study aims to determine whether structured information provided to participants verbally     and in writing by community pharmacists about blood pressure and current medicine(s) within     NMS and targeted MURs will be retained and will be associated with improved hypertension     control. Participants will be recruited from people eligible for NMS and MURs and attending     community pharmacies.   "
102855|NCT01939847|"     This study will test the feasibility of identifying patients who could benefit from tumor     molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of     the identification of possible actionable mutations that are not just biologically     interesting but are clinically relevant. The investigators will also examine the outcome data     from patients who followed the Molecular Profiling Tumor Board suggestion compared with those     who did not.      When the tissue studies are done, an additional group of patients will be enrolled to test if     the same is possible in blood samples.   "
102856|NCT01939834|"     The purpose of this study is to use an Advisory/Automated Adaptive (AAA) Control system for     insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate     the system's ability to significantly improve blood glucose levels. One component of this     study is evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system can     prevent hypoglycemia during and following exercise more efficiently during a 40 hour trial.     Another component of this study is evaluating AAA Control overnight only in 5 consecutive     overnights. This protocol represents a culmination of prior clinical trials in development of     this AAA system and benefits from the synthesis of those components.   "
102857|NCT01939821|"     The investigators are planning to do a cluster randomized trial to test the effect of     different educational programs for staff according to nursing home patients FI (fecal     incontinence). Since there are very few published trials of treatment of FI in older people,     and no rigorously evaluated studies on interventions for FI in nursing homes, or rigorously     evaluated continence education program for staff concerning continence care, a pilot study is     necessary. The aim for the pilot study is to evaluate feasibility, acceptability and     adherence according to the educational intervention, methods used and outcome measures. This     is designed to be an external pilot study. External pilot studies are small scale versions of     the main study which are not intended to be part of the main study. The pilot intervention     period is 3 month.   "
103010|NCT01937806|"     To prove that a study drug is noninferior to a control drug with a proportion of subjects who     showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week     administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic     hepatitis B patients   "
102973|NCT01938300|"     Magnesium sulphate is given to the patients during the colorectal cancer surgery under the     hypothesis that it would attenuate the postoperative hypercoagulability. The investigators     intend to characterize the changes of coagulation in colorectal cancer patients by using the     point-of-care device after the infusion of magnesium sulphate.   "
102858|NCT01939808|"     Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp     penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired surgically     with sutures (stitches). After repair, a splint is applied to the fingers, hand and wrist for     six to twelve weeks to protect the repair while the tendon heals and regains its normal     strength.      Most rehabilitation protocols use a splint in which the wrist position is kept straight     (neutral) or bent (flexed). Some groups have described splinting with the wrist cocked back     (extended) and have made the argument that this may improve outcomes, as experimental data     suggests that splinting the hand with the wrist extended increases the range of movement of     the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon     sticking down to the surrounding tissues (adhesion). Previous studies have shown no adverse     effects from splinting hands with the wrist extended, and no evidence tells us which wrist     splint position is better (a state of clinical equipoise or apparently equivalent outcomes).     This randomised trial aims to produce this evidence, and therefore improve functional     outcomes for patients in future.      We propose to carry out a study to compare the outcomes (grip strength and range of movement)     of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral     position and the other splinted in an extended position during their postoperative     rehabilitation. No changes will be made to patient assessment and management,the surgery     undertaken and the rehabilitation regime other than those to splint position. Previous work     suggests that both positions are safe and effective. Informed consent will be obtained from     all patients enrolled in the trial, and we aim to find out if the extended splint position     produces better functional results.   "
102859|NCT01939795|"     The investigators hypothesis that exercise training would potentiate the effects of cardiac     resynchronization therapy in heart failure patients.   "
102860|NCT01939782|"     This study is undertaken to explore whether compared to extension of overnight fast until     lunch versus the breakfast consumption influence the oscillation of the metabolic clock gene     expression in peripheral blood cells (PBC), at noon and after isocaloric lunch in type 2     diabetic patients.   "
102862|NCT01939756|"     Baobab oil is often used in traditional medicine as antipyretic, antioxidant,     anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in     a short time improving tone and elasticity. We want to evaluate the effects of intravesical     Baobab oil in patients with BCG-induced lower urinary tract symptoms.   "
102863|NCT01939743|"     Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of     investigation for prostate cancer in current urology practice. It is considered a minor     procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the     redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal     that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac     is a local and systemic anti-inflammatory drug and it reduces local mediators involved in     local pain.The purpose of this study is to find out the role of rectal administration of     diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post     procedural pain in prostatic biopsy with adequately calculated sample size and excluding the     patients with contraindication to procedure or diclofenac administration as these were the     shortcomings of previous studies.   "
102864|NCT01939730|"     The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8)     and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better     than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment     will also be studied.   "
102865|NCT01939717|"     Primary aim is to conduct a pilot trial to determine:        1. The feasibility and efficiency of randomisation procedures and study design        2. If recruitment rates are sufficient to adequately power a larger trial      The secondary aim is to determine the efficiency of set dancing in comparison to a control     for people with Patkinson's disease.   "
102866|NCT01939704|"     It is increasingly clear that the environment in which a child lives, plays, and goes to     school has a significant impact on their health. With the implementation of a Community to     Clinic Linkage Program (CCLiP) in the SFGH Pediatrics Clinics, we will routinely address     Social Determinants of Health when families present. We will randomize patients to receive     either the CCLiP intervention or standard of care. We will evaluate programmatic outcome,     health care utilization data and return on investment data. We hypothesize that by addressing     the environmental and social factors that contribute to health within the setting of the     medical home, we will be able to better connect families to community resources, enable more     appropriate use of healthcare resources, improve health status, and enhance patient     satisfaction.   "
102867|NCT01939691|"     Macular edema is a condition in which there is swelling in the macula, the part of the retina     that gives you your best vision. This swelling can cause your vision to get bad. When it is     diagnosed early and treated, you vision usually can be preserved. However, if the swelling     goes untreated for several months, it can cause permanent vision loss.      We think that the three eye drop regimens in this study, difluprednate, prednisolone acetate,     or nepafenac plus prednisolone acetate, might be effective in treating uveitic macular edema.     Patients who enter this study are being randomized to one of the three regimens and are being     followed for 24 weeks.   "
102899|NCT01939275|"     This pilot clinical trial studies copper Cu 64 (64Cu) tetra-azacyclododecanetetra-acetic acid     (DOTA)-trastuzumab positron emission tomography (PET)/computed tomography (CT) in studying     patients with gastric, or stomach cancer. Diagnostic procedures, such as copper Cu     64-DOTA-trastuzumab PET/CT, may help doctors study the characteristics of tumors and choose     the best treatment.   "
102868|NCT01939678|"     The purpose of this study is to investigate whether mutations in genes coding for     Na/Pi-cotransporters are associated with aortic valve calcification. A patient population     with premature aortic valve calcification treated with aortic valve replacement will be     screened for mutations in these specific genes. Furthermore, aortic valve tissue received     from the operations, will be examined for the presence of Na/Pi-cotransporters, and for     molecular characterization of the transporters.   "
102914|NCT01939080|"     Many conditions and cardiovascular diseases (including stroke) are better managed with     regular exercise training. The expected effects are partial reversal of adverse effects on     heart and blood vessel structure and function, improved glycemic, tension and weight control.      Physiologically, the aorta maintains low left ventricular after-load, promotes optimal     sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow.     Increased aortic stiffness may ultimately contribute to left ventricular dysfunction. Regular     exercise training is likely to decrease the pulse wave velocity (a measure of the aortic     compliance). Some subjects seem more responsive than others, and they may not expect the same     benefit of exercise training. To the best of our knowledge, this has not been explained yet.   "
104657|NCT01916265|"     The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and     glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients     with T1DM.   "
102869|NCT01939665|"     Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method     for tumors not amenable for surgical resection or thermal ablation, due to vicinity near     vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are     applied to tumorous tissue. These pulses alter the existing transmembrane potential of the     cell membranes, and create 'nanopores', after which the cell dies through loss of     homeostasis.      The purpose of this study is to investigate the safety of percutaneous IRE in the treatment     of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are     feasibility and efficacy of IRE based upon symptomatic response and tumor response.      Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma     (<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and     ultrasound guidance. After IRE, patients will be carefully monitored and any (serious)     adverse events are registered. Follow-up will consist of frequent CT scanning, as well as     serum CA19.9 tumor marker.      We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor     control, without causing severe complications.   "
102870|NCT01939652|"     Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a     significant number of complications involving respiratory, cardiovascular, gastrointestinal     and central nervous system, and mortality ranging up to 5%. In our study, we tested the     hypothesis that intraoperative and postoperative intravenous restrictive fluid regime reduces     postoperative morbidity and mortality and improves the outcome of the treatment of     minilaparotomy AAA repair.   "
102871|NCT01939639|"     Social touch can convey the most potent and salient of socio-emotional signals. While the     hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of     grooming in some other social species, its modulatory influence on human interpersonal touch     is unknown. The investigators expect that OXT augments the hedonic value of touch and that     this behavioral effect is paralleled at the neural level by an increased response in brain     areas mediating rewarding aspects of social touch.   "
102872|NCT01939626|"     The purpose of this study is to compare human embryo in vitro development in sequential and     single-step culture medium using time-lapse imaging.   "
102873|NCT01939613|"     The present study was to evaluate the effectiveness of colloid compared with crystalloids for     fluid resuscitation in critical burn patients with total burn surface area ≥50%.   "
102874|NCT01939600|"     Dietary fiber is a type of carbohydrate which is not digested in the human small intestine.     Whole grains are a source of dietary fiber that are used to promote health; however, using     whole grains in commercial products results in a different taste and/or texture than the     usual products made from refined grains. Thus, other types of high-fiber ingredients have     been developed which can be incorporated into food products with less effect on their taste     and/or texture. An example of this is resistant starch, defined as starch which is not     digested in the human small intestine. The digestibility of starch is usually determined     in-vitro; however, there is evidence that such methods may overestimate the amount of     resistant starch by as much as 100%. The measurement of the amount of carbohydrate in the     ileal effluent, digestive waste, of subjects with an ileostomy is considered to be the best     in-vivo method of starch digestibility. The subjects collect ileal effluent during the day     during which time they consume a polysaccharide-free diet. There is evidence that resistant     starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after     consumption. The purpose of this study will be to compare the carbohydrate content recovered     in ileal effluent of 10 subjects with a conventional ileostomy.   "
102875|NCT01939587|"     This is a single-center, double-blind, randomized trial utilizing a three-period, balanced     block design, with each period comprising a unique study product administration. The     treatments studied are PBF-680 5 mg, PBF-680 20 mg and placebo, as an orally administered     capsule. The study includes a screening visit, a selection visit, three visits for the     randomized treatment sequence, and an end-of-study follow-up visit, spanning through a 65-day     maximum study duration. The study will be conducted on 18 male or female adults aged ³18     years, with a diagnosis of stable, mild to moderate asthma as per GINA guidelines, with no     smoking or less than a 5 packs-years smoking history history, responsive to AMP airway     challenge as determined in the selection visit.      The primary efficacy variable will be the PC20 yielded from AMP airway challenge testing at     the three treatment visits. FeNO, sampled at three time points at each treatment period     visit, will be a exploratory variable. Safety assessment will include monitoring of adverse     events, physical examination, vital signs, EKGs, spirometry, serum and urine pregnancy tests,     and laboratory determinations. Blood sampling at a time-point series will provide     pharmacokinetics data.      The primary variable of the study is PC20, mg×mL-1. The PC 20 distributions will be analyzed     by treatment using ANOVA for repeated measurements, followed by post hoc pairwise comparisons     as appropriate. Other analyses will comprise FeNO, pharmacokinetics, data sets generated from     baseline characteristics and safety assessments, and discretionary expiratory analyses to     evaluate the influence of baseline and clinical covariates on the primary variable.   "
102886|NCT01939444|"     The overall is aim of this pilot study is to give a preliminary estimation of key parameters     of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be     used to design a well justified protocol for the final estimation of these parameters:        -  Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy          volunteers        -  Preliminary estimation of the maximum serum concentration (Cmax) of this formulation        -  Preliminary estimation of the time to maximum serum concentration (Tmax) of this          formulation        -  Safety of the formulation   "
102923|NCT01938963|"     This study will see if education of village doctors and aging workers in identification and     management of hypertension and depression, using standardized procedures,consultation with a     psychiatrist as needed, and collaborations between the village doctor and aging worker in     care elderly patients in the village better achieve better outcomes for their depression and     high blood pressure than usual care.   "
102915|NCT01939067|"     This study is designed to evaluate the effect of heated humidified high flow nasal cannula     (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung     function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation     requiring continuing respiratory support.   "
130206|NCT01580722|"     The purpose of this study is to determine which surgical method is better for anterior     cruciate ligament teas in outcomes.   "
102876|NCT01939574|"     This is a single-center, open-label, single arm study to explore whether potential image     biomarkers correlate with efficacy of bevacizumab combined with conventional therapy in newly     diagnosed glioblastoma.      Despite the increase in therapies available, the median survival of patients with     glioblastoma multiforme (GBM) remains less than 15 months.      The phase III pivotal study in newly diagnosed GBM also met its co-primary endpoint of     progression-free survival (PFS) which further confirm the efficacy of bevacizumab in GBM.      Early predicting the efficacy of bevacizumab combined with conventional therapy in newly     diagnosed glioblastoma could help us to identify the suitable patients to receive suitable     treatment in GBM. Thus, characterizing the blood flow and blood volume in the tumor and their     changes during therapy might provide information on vasculature growth or collapse,edema     formation, tumor growth, and/or cell death(necrosis) .We decided to investigate whether the     estimation of blood circulation in tumor, using MRI,PET could be used as a surrogate marker     to predict the early response of GBM to bevacizumab.      Several previous studies have demonstrated that the relative cerebral blood volume (rCBV)     correlated with the histologic grade of gliomas and investigated the prognostic value of the     tumor CBV for survival.In current study, We hypothesized that, the temporal changes during     anti-angiogenesis therapy in specific regions of high and low perfusion in glioblastoma might     predict the efficacy of bevacizumab.Since there is no mature PET tracer directly image     Vascular Endothelial Growth Factor (VEGF) in China,we use     18F-Galacto-arginine-glycine-aspartic acid (RGD)—— a new tracer for PET imaging of αvβ3 by     testing Standardized uptake value mean (SUVmean),Standardized uptake value max (SUVmax) and     tumor to non-tumor tissue ratios (T/NT) to indirectly reflect the VEGF expression. The     integrin αvβ3 is an important receptor affecting tumor growth, local invasiveness, and     metastatic potential. Specifically, αvβ3 is highly expressed on activated endothelial cells     during angiogenesis.      Therefore, in the pilot study, we use dynamic contrast enhanced magnetic resonance imaging     (DCE-MRI),dynamic susceptibility-contrast magnetic resonance imaging (DSC-MRI) and     18F-Galacto-RGD PET to explore the potential image biomarkers of bevacizumab used in newly     diagnosed glioblastoma.   "
102877|NCT01939561|"     Myotonia is a functional limiting symptom where the muscle stiffens on action leading to     arrest of movement. Pharmacological treatment may make the difference between a physically     restricted and a normal life. Today, patients with myotonia are treated with Mexiletine a     medications resulting in adverse events up to 40 % and which very expensive and difficult to     obtain.      Our clinic has, forced by the above problems related to Mexiletine, treated a few patients     with the drug Lamotrigine with pronounced positive effect in all. Lamotrigine belongs to the     same category of drugs as Mexiletine but has fewer and milder side effects. Based on the     similarities of the 2 drugs in pharmacological action and the positive experiences     investigators are convinced that Lamotrigine will show a positive effect if evaluated in a     broader scale. Due to the advantages of Lamotrigine compared to Mexiletine investigators find     it of outmost importance for patients that this drug is assessed formally to establish     Lamotrigine as a treatment choice for myotonia. Investigators believe that this will     potentially make a huge difference in life quality for persons with myotonia. Investigators     aim at investigating the efficacy and tolerability of Lamotrigine in the treatment of     myotonia in a randomized doublet blinded placebo controlled crossover study.   "
102878|NCT01939548|"     This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of     sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment     period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change     in symptoms for PF-02545920 from baseline compared to placebo.   "
102879|NCT01939535|"     The purpose of the study is to evaluate the value of MRI in preoperative stratification of     endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary     approach by gynaecologists, urologists or/and abdominal surgeons.   "
102880|NCT01939522|"     Children/ young people with diabetes may be at a higher risk of acquiring certain infections.     These infections include those caused by a bacterium called the pneumococcus which can cause     pneumonia, meningitis and ear infections. In the UK older children with diabetes are given a     vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). Although PPS23     causes a good immune response in children over 2 years of age it is not actually known how     well PPS23 protects against infection in children of any age. In addition there is some data     in adults and children that PPS23 may result in a reduced response to future doses of     pneumococcal vaccines (hyporesponsiveness). Because of the lack of information on how well     PPS23 protects and potential hyporesponsiveness the investigators would like to study the use     of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13). This vaccine is     known to be safe and to work well in babies and young children and there have been no     concerns about hyporesponsiveness. It has been approved for use in children up to 17 years of     age but there is little information on the size and duration of immune response to PCV13 in     children aged 6 years and older.   "
102881|NCT01939509|"     At hemodynamic level, the greater affinity of bisoprolol by the beta 1 receptor in theory     could improve the peripheral arterial perfusion and could have a greater antihypertensive     effect. At the same time, this could carry objectifiable improvements in the vascular tree,     such as the level of arterial stiffness.      This study attempts to mark the hemodynamic differences in the same individual with     hypertension and metabolic syndrome who will be exposed to both drugs at different moments.     Parameters will be objectified with impedance cardiography, pulse wave velocity and central     blood pressure assessment before and after taking each one of the drugs. The results will be     compared to the baseline data and between themselves.   "
102882|NCT01939496|"     The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood     pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes     mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents.     Overall safety and tolerability of canagliflozin will be assessed.   "
102883|NCT01939483|"     This pilot clinical trial studies irinotecan hydrochloride in treating patients with breast     cancer and brain metastases that progressed after whole brain radiation therapy or     stereotactic radiosurgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing.   "
102884|NCT01939470|"     Native American women may be considered high risk for osteoporosis due to lifestyle factors     and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the     prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate     their rate of bone loss; 3) to assess the relationship between lifestyle factors,     inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4)     determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2     follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA     and logistical regression.   "
102885|NCT01939457|"     Women presenting with incomplete abortion and eligible for treatment with misoprostol were     offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study     hypothesises that women can successfully be treated with misoprostol alone as first line     treatment.   "
102887|NCT01939431|"     Background:      - Podoconiosis is a disease of the lymph vessels in the legs and feet. It is caused by     long-term barefoot exposure to irritant soils, such as those in volcanic areas. It causes     severe swelling and disfigurement, as well as infection and chronic pain. It mostly affects     people who live in tropical Africa, Central and South America, and India. The reasons why     some people develop this disease and others do not is not well understood. Researchers want     to study people with the disease and healthy volunteers in Ethiopia. They will collect skin     and blood samples to study genetic and other aspects of the disease.      Objectives:      - To collect skin and blood samples to study genetic and other aspects of podoconiosis.      Eligibility:        -  Individuals at least 18 years of age who have podoconiosis (early stage or advanced          stage).        -  Healthy volunteers at least 18 years of age.        -  Participants will be recruited from a study clinic and hospital in Ethiopia.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Blood samples will be collected. A skin biopsy will be performed to collect tissue for          study. People who have podoconiosis will provide affected and unaffected tissue. Healthy          volunteers will provide a single skin biopsy sample.        -  Treatment will not be provided as part of this study.   "
102888|NCT01939418|"     This study consists of two parts. In a phase Ib part, investigators will explore the     recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with     metastatic TNBC. After completing the phase Ib part, investigators will review the data and     discuss with Novartis before the start of a phase II part. In the phase II part,     investigators will compare the efficacy of the gemcitabine and cisplatin with or without     RAD001 in patients with metastatic TNBC.   "
102889|NCT01939405|"     The study aims are to develop and test the feasibility of a pediatric physical activity     intervention that incorporates personal information on use of the built environment, and test     the intervention's preliminary efficacy at increasing physical activity. The investigators     hypothesize that it will be feasible to incorporate and measure changes in empiric GIS     (geographic information system), GPS (global positioning system), and accelerometer feedback     in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data     collection (primary measure of feasibility), ii) Participation rates among adolescents in the     intervention group compared to the control group, and iii) Acceptability to patients as     measured by adolescent satisfaction.   "
102890|NCT01939392|"     This is a global, multi-center, prospective, randomized, controlled study of the safety and     effectiveness of renal denervation with the OneShot Renal Denervation System in patients with     uncontrolled hypertension.   "
102891|NCT01939379|"     The purpose of this study is that an adductor canal nerve block (putting numbing medicine     near the nerve) has been shown to produce excellent pain relief with less pain medication use     after knee replacement surgery.The investigators will be comparing the amount of pain relief     following knee replacement surgery when you have a nerve block in place. There will be     approximately 66 subjects participating in this study. After surgery subjects will receive     numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA     (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours     around the clock with the option to receive more pain medication if needed. Subjects will     participate in the study up to 3 days.   "
102892|NCT01939366|"     The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in     patients when compared to placebo (a tablet that does not contain active product) and when     compared to a marketed product containing pregabalin (Lyrica®, indicated for your pain     condition). Furthermore, this trial will be undertaken to find out if the patient's general     health and well-being improves under trial treatment.      The concentrations of cebranopadol in the blood will be investigated to get a better     understanding of how it is absorbed from the gut, distributed and broken down in the body,     and eliminated from the body.   "
102893|NCT01939353|"     This is a Phase 2 exploratory study being conducted to evaluate the efficacy and safety of     EB-1020 SR in treating adult male patients who meet DSM-IV-TR diagnostic criteria for ADHD on     the M.I.N.I.-Plus. Evaluations include determining an effectiveness signal for ADHD and     related symptoms and exploring dosing, tolerability, onset of action, and duration of effect.     Dose-response/tolerability relationships with EB-1020 SR will also be explored. The 1-week     placebo lead-in also will be used for informal safety comparison purposes.   "
102894|NCT01939340|"     Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing     chemotherapy. The purpose of this study is to assess prevalence of cachexia and low     nutritional intake and the impact on quality of life, fatigue and mortality in patients     undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease and     chemotherapy, respectively.   "
102895|NCT01939327|"     The incidence of non-Hodgkin's lymphoma (NHL) is steadily increasing worldwide. At present,     it is the sixth most commonly diagnosed cancer in France, with 10 000 estimated new cases and     5200 deaths annually. An increasing NHL incidence at a rate of 3-4% per year was observed for     the 1970s and 1980s. This stabilized in the 1990s, nevertheless still with an annual rise of     1-2%, resulting in almost a doubling of the NHL incidence during last 40 years. This rise has     been noted worldwide, particularly in elderly persons >55 years. Increases in high-grade NHL     and extranodal disease are predominant. There is about 80% of B-cell histology, approximately     90% of follicular lymphomas and about 70% of aggressive lymphoma patients present with     disseminated disease at diagnosis. The prognosis of NHL depends on the histological type,     stage and treatment. Indolent lymphomas have a relatively good prognosis with survival time     as long as 10 years, but they are usually incurable in advanced stages. Aggressive NHL     constitutes about 50% of all cases of NHL in Western Europe. Approximately 50 - 60% of these     patients can be cured with immuno-chemotherapy regiments. Subsequently, almost 50% of     patients will eventually relapse or become refractory to treatment. The prognosis for     patients with refractory or relapsed aggressive NHL is generally poor. The response rates to     salvage therapy regimens range from 20 to 40%. Patients who present with refractory disease     have the worst prognosis, with a median survival of less than six months. Only a minority of     patients can be given high dose chemotherapy, the majority being ineligible due to disease     progression.      By modulating the immune system through dendritic cells and NK cells, by changing the     cytokine milieu, and by their anti-angiogenic effects, IMiDs in combination with mabthera     (rituximab) resulted in augmented in vitro and vivo antitumor effects against B-cell     lymphoma.      As concerns the timing of administration and doses of medications, phase I/II studies are     ongoing with R-CHOP in combination with Revlimid (Lenalidomide) in DLBCL. The latest     presentation is by Nowakowski et al. at ASCO meeting in June 2010. This study determined the     maximum tolerated dose of Revlimid(Lenalidomide)administered on days 1-10 with standard     R-CHOP (R2-CHOP). NO DLT was found and 25 mg of Revlimid(Lenalidomide)was the recommended     dose for phase II with enrollment of 32 patients. These encouraging results permit to     introduce in our much less toxic protocol 25 mg of Revlimid(Lenalidomide)as initial dose,     with progressive reduction in case of toxicity.      As regards the dose and timing of Mabthera(Rituximab), in DLBCL it was traditionally used as     a single 375 mg/m2 injection/cycle. Pre-clinical data suggests that for the optimal NK     enhancement Revlimid(Lenalidomide)must be administrated several days (approx. 7 days) before     Mabthera(Rituximab)injection. So, our protocol provides Mabthera(Rituximab)IV administration     at day 7 of Revlimid(Lenalidomide).      Performed parallel biological investigation of NK status will permit to confirm this     hypothesis with possible correction of timing and number of administrations of     Mabthera(Rituximab)par cycle.   "
102896|NCT01939314|"     The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block     utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the     duration of the analgesia.   "
102897|NCT01939301|"     This is a randomized, double blind study to treat subjects diagnosed with pulmonary embolism     with inhaled nitrix oxide. In this clinical trial investigators will randomized patients to     receive inhaled nitric oxide or sham (nitrogen + oxygen) for 24 hours. Patients must have a     submassive pulmonary embolism (PE) and evidence of right ventricular (RV) heart dysfunction.     Investigators hypothesize that the administration of inhaled NO + oxygen to patients with     severe submassive PE will improve RV function, reduce RV strain and necrosis and improve     dyspnea (difficulty breathing) more than sham oxygen treatment.   "
102898|NCT01939288|"     What is known?        -  Disorders of peripheral circulation result in vascular morbidity and mortality        -  Augmentation of peripheral circulation has been shown to be of benefit in both venous          and arterial disease        -  The benefit of intermittent pneumatic compression is clinically well evidenced.        -  The use of intermittent pneumatic compression is limited by compliance issues related to          sleeve application and external power source.      What new information will this trial contribute?      - This evaluates the haemodynamic effect of a new electrical device for augmentation of     peripheral circulation   "
103047|NCT01937312|"     The purpose of this study is to demonstrate the additive effect of brinzolamide     1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or     ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.   "
102900|NCT01939262|"     Patients will be randomized into the control or intervention group. Based on patient     preference, the intervention group will be trained for one hour in either individual or group     format on vegan diet. They will also be directed to www.pcrm.org and www.drmarymd.com for low     glycemic, animal free, low fat food options and support. The control group will continue     their normal omnivorous diet program. Twenty-four hour food recalls will be obtained at the     start and end of the trial, and once a week for the 6 weeks of the trial by telephone.     Patients will undergo a final interview at the end of the 6 week study period. The     intervention group should strive to obtain 90% of their calories from plants. They will be     encouraged to eat freely and not count calories. Patients will undergo additional individual     consultation as needed to promote compliance and answer specific questions.      Over the 6 weeks, the Patient Global Improvement of Change (PGIC) and the 36 item short form     health survey (SF-36) will be performed weekly by telephone. Patient will perform a Visual     Analog Scale (VAS) of their pain level randomly daily on their own. C-reactive protein levels     will be assessed at the beginning and end of the study at Munson Medical Center Laboratories     as a secondary measure of diet changes.      There have been no published prospective randomized controlled trials assessing whether a     vegan diet would benefit osteoarthritis. The specific aim of this study is to determine if a     vegan diet will result in subjective reduction in perceived pain and limitations to function     in patients with osteoarthritis.   "
102901|NCT01939249|"     BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The     purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the     Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary     lesions. The study is powered for non-inferiority with respect to Target Vessel     Failure(TVF)at 12 months.   "
102902|NCT01939236|"     The purpose of this study is to determine whether traditional Chinese medicine as     complementary treatment is safe and effective in the treatment of chronic heart failure.   "
102903|NCT01939223|"     To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects     with colorectal cancer (CRC) after curative resection of liver metastasis and completion of     all planned chemotherapy.   "
102904|NCT01939210|"     This randomized pilot clinical trial studies the effects of meditation-based breathing     training on patients' control of their breathing patterns and breathing-related movement, as     well as on their psychological distress and treatment experience during radiation therapy.     Meditation-based breathing training may decrease breathing-related movement and the amount of     stress by improving breathing patterns in patients with abdominal or lung cancer undergoing     radiation therapy.   "
102905|NCT01939197|"     The purpose of this study is to assess the safety and efficacy of     ombitasvir/paritaprevir/ritonavir with and without dasabuvir coadministered with and without     ribavirin for 12 and 24 weeks in adults with genotype 1 or 4 Chronic Hepatitis C Virus     Infection with Human Immunodeficiency Virus, Type 1 coinfection.   "
102906|NCT01939184|"     The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses     of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.   "
102907|NCT01939171|"     To determine the efficacy and Security of Thymoglobuline in cadaveric donor Efficacy: To     demonstrate that in cadaveric donor, Thymoglobuline diminished graft alloreactivity by     decreasing expression of inflammatory markers in graft biopsies Security:To demonstrate that     the administration of Thymoglobulin does not have side effects in renal recipients.   "
102908|NCT01939158|"     The purpose of this study is to compare the immediate and long term (up to 5 years)     immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose     or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if     co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar     13 adversely impacts the immunogenicity of either of the vaccines.   "
102909|NCT01939145|"     This is a prospective, randomized trial comparing the outcomes for Prontosan versus normal     saline as the solution for negative pressure wound therapy with instillation (NWPTi).     Negative pressure wound therapy (NPWT) is a well established method of treatment for acute     and chronic wounds. The combination of negative pressure with instillation of a solution is a     relatively novel concept that has gained popularity and is currently used nationally and     internationally. NPWTi is the standard of care for our division. Despite the growing use,     there is limited information regarding the selection of the ideal instillation solution. This     is a single site, investigator initiated, NPWTi study comparing the use of Prontosan with     normal saline for the adjunctive treatment of the acutely infected wound that requires     hospital admission. A total of 100 subjects will be included with 50 subjects in each     treatment arm. The outcomes that will be measured are 1) number of operations, 2) length of     hospital stay, 3) % of wounds closed prior to discharge, 4) time to closure prior to     discharge, 5)% remained closed at 30 day follow-up, and 6) reduction of qualitative bacterial     cultures. The results from this study will better characterize the most appropriate use of     NPWTi.   "
102910|NCT01939132|"     Psoriatic arthritis is a heterogeneous chronic inflammatory disorder involving joints, tendon     sheaths, entheses, and the axial skeleton as well as skin and nails. This is an open-label     trial with H.P. Acthar Gel (80 units/1mL) Subcutaneous injection administered twice weekly.     To evaluate the signs and symptoms of psoriatic arthritis after 12 weeks, including American     College of Rheumatology 20,Clinical Disease Activity Index, Disease Activity Index 28,     Dactylitis and adverse events.   "
102911|NCT01939119|"     The purpose of this study is to examine the body-fluid balance in patients with retinal     vascular occlusion and the influence of drinking habits and hemodilution on the degree of     body hydration.   "
102912|NCT01939106|"     To assess the safety and performance of an enhanced one piece drainable pouch in subjects     with an ileostomy.   "
102913|NCT01939093|"     The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an     atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic     disorder, in individuals with MAP.   "
102956|NCT01938521|"     The aim of this study is to examine whether the chronic administration during 12 weeks of     polyphenols contained in Red Grape Cells (RGC) powder has an effect on mRNA expression of     SIRT1 and Clock Genes, on circulating levels of HbA1c, lipids, blood pressure and on     postprandial response of glucose, lipids, insulin, C-peptide and GLP-1 in patients with type     2 diabetes .   "
102916|NCT01939054|"     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in     the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting     tyrosine kinase activation. This is a randomized, controlled, open-Label, multicenter, phase     Ⅱ clinical trial of nimotuzumab plus Docetaxel and Capecitabine（TX）versus Docetaxel and     Capecitabine（TX）as first-line treatment in patients with recurrent/metastatic triple negative     breast cancer.   "
102917|NCT01939041|"     Robot-assisted training (RT) devices developed to date have a significant impact on stroke     rehabilitation. Several research groups have developed the robotic devices and examined their     efficacy on improving UL function after stroke. All these robotic devices have been applied     in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for     the mechanisms of RT-induced recovery, the relative treatment effects of unilateral vs     bilateral robotic trainings, and the impact on physiological responses is still lacking.      The primary purposes of this study are to examine (1) the relative immediate treatment     effects of unilateral vs bilateral RT on motor impairments/performance and daily functions in     patients with subacute stroke; (2) the long-term benefits of unilateral vs bilateral RT by     conducting a 6-month follow up evaluation; and (3) the effects of RT on movement     reorganization as well as on the physiological markers of inflammation, oxidative stress,     erythrocyte deformability, and blood glucose. These overall findings will help better     understanding of the efficacy of RT on functional outcomes, movement reorganization, and     physiological markers. The investigators would additionally explore the possible differential     treatment effects in patients with different levels of motor severity (i.e., moderate vs.     severe).      The investigators hypothesize that (1) both unilateral (the InMotion3) and bilateral (the     Bi-Manu-Track) robot-assisted training would bring larger benefits on motor performance and     daily function than the control treatment; (2) such benefits would retain during the     follow-up; (3) there would be differential immediate and retention effects of unilateral (the     InMotion3) and bilateral (the Bi-Manu-Track) robot-assisted training on different outcome     measures; (4) better movement reorganization as well as physiological marker expressions     would be found in both robotic groups compared to control group; and (5) there would be     differential effects of robotic therapy between participants with moderate vs. severe motor     impairment.   "
102918|NCT01939028|"     This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial     cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove     endometrial cancer and affected lymph nodes.   "
102919|NCT01939015|"     -  The aim of this study is to compare the standard and 3D miniplates fixation in          mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain,          hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one          method over the other.        -  Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will          used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients          returned 7 days after surgery for clinical evaluation . The patients will be examined          radiographically for accuracy of the reduction, screw positioning, adverse reactions in          the vicinity of screw placement, and bone healing. the complications encountered will be          recorded and treated. The clinical evaluations will be performed by 1 surgeon at each          institution.        -  The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia,          and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for          infection will based on either of the following conditions: 1) purulent discharge from          an incision and 2) serosanguineous drainage and a wound culture positive for a known          pathogen. All the patients will evaluated postoperatively by a single assessor.        -  Statically analysis :      Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤     0.05 will be considered statistically significant.   "
102920|NCT01939002|"     The primary objective of this study is to determine the proportion of participants with     relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS)     after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017).      Secondary objectives are: to determine the severity and frequency (measured by flu-like     symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in     number of hours) of FLS in these participants; to determine the effect of BIIB017 on other     participant-reported outcomes, including treatment satisfaction (measured with the Treatment     Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the     Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether     interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to     assess the use of additional medications (in addition to current medications used to treat     FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout     the study period; to characterize the immunogenicity profiles of participants switching from     prior IFN-β therapy to BIIB017.   "
102921|NCT01938989|"     The purpose of this study is to evaluate photostress recovery with blue light filter clip-on     glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been     replaced with an artificial lens (intraocular lens) during cataract surgery]. This study will     enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for     at least 3 months.   "
102922|NCT01938976|"     Study Hypotheses:        1. adolescents in intervention schools who are given Triple A program plus ASP will show          more awareness in regards to cigarettee smoking health effects and less nicotine          dependencethan those in the control schools who are given Triple A alone.        2. adolescents with asthma in intervention schools who are given Triple A program plus ASP          will show less asthma symptoms and better control than those in the control schools who          are given Triple A alone.        3. adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide          (CO) in their breath than those who are not active or passive smokers.        4. there is a positive correlation between self-report questions regarding student smoking          status and levels of CO in their breath   "
123851|NCT01664884|"     The aim of this study is to explore the levels of internalized stigma in a sample of young     patients with bipolar disorder or schizophrenia.   "
102957|NCT01938508|"     This study compared the bioavailability of two formulations 100 mg (one capsule or other     respectively) of each one of the products, of Minocycline, under fasting conditions, in     healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours prior     to study) conditions, cross, with two treatments, two periods, two sequences (2x2) randomized     sequence, balanced, and with a washout period of at least 7 days between each dose, in 24     healthy volunteers.   "
102958|NCT01938495|"     The study is being conducted to determine if DPS treatment for people with ALS and     hypoventilation is associated with improved survival or diaphragm function.      The primary objective of the study is to conduct a multi-center, randomized controlled     clinical trial comparing standard of care (control) to diaphragm stimulator treatment with     the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival.      The secondary objective of the study is to conduct a multi-center, randomized controlled     clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with     hypoventilation.   "
102924|NCT01938950|"     The current epidemic rate of childhood obesity is a leading health concern as     overweight/obese youth may suffer from comorbid conditions, once considered exclusive to     adults. It has been suggested that physical inactivity is a major determinant of obesity and     obesity-related health risk in children and adolescents. Recent studies in adults report that     the combination of aerobic and resistance exercise is a better strategy than aerobic or     resistance exercise alone for reducing risk factors for type 2 diabetes. Currently, the most     effective exercise modality for concurrent reductions of adiposity, in particular abdominal     fat, and risk factors for type 2 diabetes and cardiovascular disease (CVD) is unknown in     adolescents. Therefore, we will employ a randomized trial to examine the effects of a     long-term aerobic exercise, resistance exercise, and a combination of both exercise regimens     on: 1) in vivo insulin sensitivity, glucose tolerance and risk for type 2 diabetes, 2) total     adiposity, skeletal muscle mass, visceral adiposity and ectopic fat in the liver and skeletal     muscle, and 3) traditional and non-traditional risk factors/markers for CVD in overweight     boys and girls. We will recruit 168 sedentary overweight (BMI >85th percentile) adolescent     boys and girls aged 12-17 years old and randomly assign them to one of three 6-month     intervention groups (n = 56 each group): 1) aerobic exercise (180 min/week), 2) resistance     exercise (180 min/week), or 3) aerobic and resistance exercise (180 min/week) group. A weight     maintenance diet (55-60% carbohydrate, 15-20% protein, and 25-30% fat) will be prescribed and     monitored for all groups, so that any changes in energy balance will be induced by exercise     intervention alone (e.g., no calorie restriction). We believe that this proposed application     will have a significant implication that is directly relevant for one in three American     adolescents who are at increased risk of developing obesity-related co-morbidities.   "
102925|NCT01938937|"     The purpose of this study is to determine if transcranially administered bright light has     acute effect on anxiety symptoms.   "
102926|NCT01938924|"     A study to investigate if the gekoTM device improves flow through vascular bypass grafts   "
102927|NCT01938911|"     To test a psychopharmacological intervention strategy which may provide new insights into the     mechanisms underlying the physiological hyperreactivity to stress observed in hypertension,     we plan to test the effects of the neuropeptide oxytocin and social support on the     neurobiological and psychological responsiveness to social stress. The study population for     this project consists of 80 hypertensive and 80 normotensive non-smoking medication-free men.     We expect exogenous oxytocin administration to enable hypertensives to effectively take     advantage of the provided social support. Thereby, oxytocin may enhance the effect of social     support on reducing the previously observed physiological hyperreactivity to stress in     essential hypertensives.   "
102928|NCT01938898|"     The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) is an opportunity     to conduct methodology research relevant to many features of a large prospective study.     NICOLA will begin in earnest in Northern Ireland in 2013 and is being conducted by a     multidisciplinary team in the Centre for Public Health at Queen's University Belfast. It is     an omnibus programme of research on ageing that will continue for at least 10 years and will     recruit 8500 middle-aged people in Northern Ireland and follow them into old age, providing a     comprehensive assessment of their physical and mental health, their lifestyles, and their     social and economic decision making. NICOLA will look at how they perceive disability and     health, and how this differs between well-off and disadvantaged groups. NICOLA will also     study various genetic, biological and psychological factors, including how participants     perceive risk and value their time, and the effect of this on their retirement behaviour     (including how they manage their money and their health). People over the age of 50 will be     invited to take part and asked to complete detailed interviews and questionnaires every 2     years and health assessments every 4 years.      The overall aim of this research is to examine the impact of differing invitation letters     offered to participants on study recruitment rates.   "
102929|NCT01938885|"     Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is potentially     fatal, as it can lead to sudden severe haemorrhage. The risk of developing posttraumatic     hepatic pseudoaneurysm is one of the reasons why some trauma centres do follow-up CT of     patients with liver injuries to take the therapeutic consequence. The aim of this study was     to investigate the occurrence of HPA post liver trauma.   "
102930|NCT01938872|"     to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee     angioplasty in terms of restenosis at 12 months   "
102931|NCT01938859|"     The purpose of the AGTs-BD study is to compare the treatment outcome and safety profiles     between different mood stabilizers combination treatments in the patients with bipolar     disorders, currently suffered from depression episode.   "
102932|NCT01938846|"     The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI     860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs,     patients are entered sequentially into escalating dose cohorts. Secondary objectives are     objective response and disease control according to RECIST criteria version 1.1   "
102933|NCT01938833|"     This phase I/II trial studies the side effects and best dose of romidepsin when given     together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well they     work in treating patients with metastatic inflammatory breast cancer. Romidepsin may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving romidepsin and paclitaxel albumin-stabilized nanoparticle     formulation may be an effective treatment for inflammatory breast cancer.   "
102934|NCT01938820|"     Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to     metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2     years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year,     entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every     six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver     ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate     regression rate of liver fibrosis 1.5 years after initial therapy.   "
102942|NCT01938716|"     The goal of this clinical research study is to learn if gemcitabine given during surgery can     enter pancreas cancer cells in patients who have already received chemotherapy and radiation.      Gemcitabine is a drug used to treat pancreatic cancer. However, it has not previously been     studied if gemcitabine can enter pancreatic cancer cells. Gemcitabine is designed to block     the growth of cancer cells, which may cause cancer cells to die.   "
103009|NCT01937819|"     High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated     visual aids as a means of improving the quality of bowel preparation. We assess the effect of     patient-judging dose adjustment of bowel preparation solution for bowel preparation using     SMARTPHONE application on the quality of bowel preparation.   "
102935|NCT01938807|"     Despite multidisciplinary care and advancements in therapeutics and technology, health     outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to     poor outcomes is suboptimal diabetes management in pediatric patients and their families. The     premise of this research project is that patients and families do not have adequate resources     to meet the level of diabetes management that translates to better outcomes. Therefore, we     will give them a valuable tool to improve their overall management. The tool is CareCoach.      Research shows that enhancing communication and partnership among patients, parents, and     providers is especially critical for optimal outcomes in pediatric diabetes. Communication     gaps and conflict can complicate the already complex provider-patient interactions and daily     management. We have therefore designed, refined, and made available to consumers a new     mobile-based intervention, CareCoach, to improve communication; build trust among providers,     patients and parents; and increase overall satisfaction with the quality of diabetes care.     This web/mobile application is designed to help patients unobtrusively audiorecord their     clinical encounters, track their medical consults and treatment plans, review information     from past visits, create visit discussion guides, and track adherence to medication and     dosing schedules. In addition, because mobile-based applications are inexpensive to     administer, portable, and available at all times of day, CareCoach holds great promise for     communication coaching and contributing to improved diabetes management.      We hypothesize that CareCoach will improve patient-parent-provider communications, build     patient-parent-provider trust, and increase overall satisfaction with clinical interactions     in a sample of children with type 1 diabetes and their parents. These improvements will lead     to significant gains in diabetes management, setting the stage for optimal health outcomes.     To test the effectiveness of CareCoach, we will conduct a randomized controlled trial     comparing the CareCoach intervention to standard care in a sample of 60 children with type 1     diabetes and their parents.   "
102936|NCT01938794|"     Accurately measuring how many calories a person burns each day is difficult to do.     Researchers can do this with a technique called doubly labeled water (DLW). This involves     drinking water that is labeled with a non-radioactive tracer. After a few hours, the     labeled water can be detected in the urine. To measure how many calories are burned (Total     daily energy expenditure, TDEE), urine samples are collected several days apart. Although     this technique is accurate, it is also challenging for two reasons. First, the labeled water     is expensive. Second, the urine samples are analyzed using equipment (Isotope Ratio Mass     Spectrometer, or IRMS) that is expensive and difficult to operate. The goal of this project     is to develop a new instrument to perform DLW measurements of TDEE. This instrument, called a     triple isotope water analyzer (TIWA) is less expensive and easier to operate than IRMS.     Additionally, since the TIWA is more accurate than IRMS, it may potentially reduce the amount     of labeled water required to measure TDEE, and thus reduce costs. The purpose of this study     is to compare the accuracy of measuring TDEE from labeled water using the new instrument     (TIWA) and from the traditional approach (IRMS). We will also compare the accuracy to the     measurement of TDEE from whole-room indirect calorimetry (metabolic room), which is     considered the most accurate way to measure TDEE.   "
102937|NCT01938781|"     Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar     to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir     alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus     pegylated interferon (peg-IFN) for 1 year, entecavir for another additional 0.5 year.     Patients will be assessed at baseline, at every six months for blood count, liver function     test, HBVDNA, AFP, prothrombin time, thyroid function, liver ultrasonography, and Fibroscan.     The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5     years after initial therapy.   "
102938|NCT01938768|"     Severe external and internal bleedings are common in multiple trauma patients. Uncontrollable     blood loss is the cause for about one third of all trauma deaths. A number of blood clotting     mechanisms are known to be triggered by major blood losses. These mechanisms shall secure the     organisms from loosing even more blood. To avoid an overshooting clotting behavior,     inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic) mechanism is     the fibrinolysis that is based on the conversion of plasminogen to plasmin. In severe     bleeding situations this mechanism tends to overshoot and therewith contributes to the     severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in     approximately one third of all multiple trauma patients. Mortality rates are increased in     these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion from     plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A large     study showed positive influence of tranexamic acid on mortality rates and blood loss in     severely injured patients, when it was administered in an early clinical setting. In this     study we want to answer the question wether a hyperfibrinolysis can be seen in an early     prehospital (on the scene) setting and how it is influenced by an early prehospital     administration of tranexamic acid.   "
102939|NCT01938755|"     Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of     regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space,     generally through a fine needle.      There is no generic hyperbaric form of levobupivacaine currently available so we aimed in     this study that to find the appropriate concentration of the levobupivacaine which achieves     unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less     motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be     suitable for outpatient anesthesia.   "
102940|NCT01938742|"     This is a Phase II randomized, double-blinded, controlled study in up to 700 males and     non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety,     reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine     administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and     without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL     dose). Subjects will receive two doses via intramuscular injection, approximately 21 days     apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time     points with safety follow-up to continue through one year post dose 2. The duration of the     study for each subject will be approximately 13 months.   "
102941|NCT01938729|"     This is a Phase I study, which means we want to find out what effects, good and/or bad, this     combination of drugs may have on the patient and the liver cancer at different dose levels.     All patients will have an operation to remove tumors in the liver and may have a pump placed     in their abdomen.      On this study, both drugs given have been used in other patients for treatment of     cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food     and drug administration (FDA) for treatment of liver cancer, but the two drugs have only been     combined in a few patients.      That means that in this trial we also want to find out if this combination is safe.      The study will also evaluate if this treatment works in delaying or stopping the cancer from     coming back after surgery.   "
103048|NCT01937299|"     The purpose of this study is to demonstrate the additive effect of brinzolamide     1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or     ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy (TRAVATAN     Z®).   "
102943|NCT01938690|"     Approximately two thirds of stroke survivors have profoundly impaired function of the upper     limb. Currently the main stay of the treatment for upper limb motor function is     rehabilitation therapy focusing on repetitive and skillful task practice (task-oriented     therapy) which has been shown to induce substantial functional reorganization in the     undamaged motor cortex and functional recovery. In spite of rehabilitation therapy,     functional recovery of arm and hand function is limited to one third of stroke survivors and     there is a great need for adjunct treatment to current practice. Repetitive Transcranial     Magnetic Stimulation (rTMS) is a noninvasive means of stimulating nerve cells in superficial     areas of the brain and emerging as a novel method of modulating cortical excitability and     promoting functional recovery after stroke. There have been studies using rTMS to improve     motor function after stroke. However, whether 1Hz rTMS can enhance the effect of the     task-oriented therapy on upper limb function after stroke has not been investigated. In this     pilot proposal, we intend to investigate the feasibility of 1Hz rTMS on unaffected hemisphere     as an adjunct to task-oriented therapy to improve upper limb motor function among stroke     patients. The information obtained from this pilot study will provide a platform for the     future randomized control trials combining the rTMS and task-oriented therapy to enhance     motor recovery among stroke survivors.   "
102944|NCT01938677|"     The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular     schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the     hearing is preserved in most patient years after the gamma knife treatment. Recent     prospective data suggests that radiosurgery could be a hearing preserving treatment for these     patients.      The main objective of this study is to evaluate if GKRS can inhibit progression of hearing     loss in patients with VS. Patients with preserved hearing will be offered to participate in     the study and randomized ether to GKRS or initial conservative treatment for their vestibular     schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and     audiometry and evaluated after one, three and five years after treatment.   "
102945|NCT01938664|"     The purpose of this study is to see if a drug called Candesartan will help to reduce use of     cocaine.   "
102946|NCT01938651|"     This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and     magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic     procedures may be a more sensitive way to detect breast cancer.   "
102947|NCT01938638|"     The purpose of this study Part A is to determine the safety, tolerability and the     pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either     refractory to or ineligible for treatment with standard agents.      The purpose of this study Part B is:      Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose     (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating     factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced     malignancies.   "
102948|NCT01938625|"     The purpose of the study is to evaluate effect of steady-state (when the amount of drug     administered (in a given time period is equal to the amount of drug eliminated in that same     period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a medication     does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when     administered as a combinational regimen in post-orthotopic liver transplantation (OLT)     participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness     of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with     respect to the proportion of HCV genotype 1b infected post-OLT participants achieving     sustained virologic response 12 weeks after end of treatment.   "
102949|NCT01938612|"     This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with     a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics     in patients with advanced solid tumor followed by an expansion phase in patients with     advanced solid tumors.   "
102950|NCT01938599|"     To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment of     plaque psoriasis.   "
102951|NCT01938586|"     The purpose of this study is to compare the cosmetic outcome between buried intradermal and     superficial cutaneous suture closures versus buried intradermal sutureand superficial     Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following     elliptical excision of benign or malignant lesions   "
102952|NCT01938573|"     This phase I/II trial studies the side effects and best dose of sirolimus when given together     with cisplatin and gemcitabine hydrochloride and to see how well they work in treating     patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or     suppress the immune system in different ways and stop tumor cells from growing. Drugs used in     chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving sirolimus together with cisplatin and gemcitabine     hydrochloride may be an effective treatment for bladder cancer.   "
102953|NCT01938560|"     As part of a post-marketing commitment, GSK will conduct a survey of prescribers' and     pharmacists' understanding of the risk of urinary retention with retigabine products. This is     to address the effectiveness of the Risk Evaluation and Mitigation Strategy (REMS) as     outlined in the REMS approved by the FDA on 10th June 2011. The objectives of this survey are     to assess prescribers' and pharmacists' understanding of the risk of urinary retention and     the symptoms of acute urinary retention potentially associated with retigabine use as     evaluated by a survey instrument.      This is a cross-sectional study of approximately 200 physicians (e.g.     neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in     the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at     least once in the last 3 months. The primary outcome of the survey is the proportion of     physicians and pharmacists providing correct responses to a series of questions concerning     the risk of urinary retention and the symptoms of acute urinary retention that may be     associated with retigabine. The risks captured will be those described in the retigabine Dear     Healthcare Provider (DHCP) letters, specifically risks of urinary retention.   "
102954|NCT01938547|"     To evaluate the efficacy, safety and dosing of an intravenous (IV) infusion of clevidipine     for blood pressure (BP) management in pediatric participants in the perioperative setting.   "
102955|NCT01938534|"     Prospective study : Helicobacter pylori eradication therapy in accordance with past     antibiotics use.   "
102959|NCT01938482|"     The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan     will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and     safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),     after topical administration on healthy subjects and acne patients. Study SCD117226 will be a     randomized, single-blind, dose-rising study to evaluate the safety, tolerability and     preliminary pharmacokinetics of single and 14 day repeat topical applications of GSK1940029     gel on the intact skin of healthy human subjects. Part 1: (single-dose) subjects will receive     0.3% or 1% GSK1940029 (or matching vehicle), as a single approximately (App) 24 hour (h)     (22.5h) application to a surface area of 400 square centimeter (cm^2) (0.3%), 400 cm^2 (1%)     or 1200 cm^2 (1%), respectively, in each of three sequential cohorts. Part 2: (repeat-dose)     subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as 14 daily App24h (22.5h)     application to a surface area of 400 cm^2 (0.3%), 400 cm^2 (1%) or 1200 cm^2 (1%),     respectively, in each of three sequential cohorts. Parts within Study SCD117225 and Study     SCD117226 will have interdependencies. No significant primary irritation signal in Study     SCD117225 Part 1 (primary irritation) would allow initiation of Study SCD117226 Part 1. Once     safety, tolerability and exposure information are determined in Study SCD117226 Part 1, then     Part 2 (cumulative irritation) of Study SCD117225 may be initiated along with Part 2 of Study     SCD117226. No significant cumulative irritation signal (study SCD117225 Part 2) in     combination with adequate 14-day safety (study SCD117226 Part 2) would allow initiation of     Part 3 (facial irritation) of Study SCD117225.   "
102960|NCT01938469|"     Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut     peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric     bypass surgery (GBP).   "
102961|NCT01938456|"     The primary purpose of this study is to evaluate the safety and tolerability of the     combination therapy of trametinib and docetaxel with growth factor support in Japanese     subjects with Stage IV or a postoperative recurrence non-small cell lung cancer (NSCLC). This     study data will be used for making decision for further Japanese development plan for NSCLC.     Six evaluable subjects will be enrolled in a dose level to evaluate the safety and     tolerability of the combination treatment. Dose-limiting toxicity will be assessed during the     first 21 days of combination therapy.   "
102962|NCT01938443|"     The purpose of this study is to assess the safety of combination treatment of GSK2256098 and     trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the     study will identify a maximum tolerated combination dose of GSK2256098 and trametinib. This     study is a Phase I, open-label, dose-escalation study to determine maximal tolerated dose     (MTD) and the recommended Phase 2 dose (RP2D) and regimens for oral MEK inhibitor trametinib     (once daily [OD]dosing) and the oral FAK inhibitor GSK2256098 (twice daily [BID] dosing). The     synergy of the combination was observed over a wide range of concentrations and results in     several-fold reduction in compound concentration to achieve equivalent biological responses     compared to either single agent. The dose and schedule of dosing may be modified based on     emerging safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. The study will be     conducted in two parts; Part 1 Dose Escalation to determine the MTD and RP2D and Part 2     Expansion Cohort to further evaluate the safety and tolerability of trametinib and GSK2256098     at the RP2D and determine clinical activity. Additionally, in Part 1 Dose Escalation,     additional subjects with malignant pleural mesothelioma (MPM) will be recruited at doses that     are considered tolerable in order to assess PD in MPM subjects at each dose (the     Pharmacodynamic Cohort). The Expansion Cohort will be limited to subjects with MPM who have     progressed or are intolerant to first-line therapy.   "
102963|NCT01938430|"     This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus     ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic     genotype 1 or 4 hepatitis C virus (HCV) infection.        -  Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;        -  Cohort B: post-liver transplant, with or without cirrhosis;        -  Group assignment within cohorts is based on severity of liver impairment at screening          (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence          of disease for fibrosing cholestatic hepatitis (FCH) groups)        -  Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.   "
102964|NCT01938417|"     This study aimed to assess the systemic absorption and disposition of tobramycin in patients     treated with a tobramycin-laden bone graft substitute (Osteoset® T).   "
102965|NCT01938404|"     To assess and evaluate the safety of octaplas™ in comparison to standard plasma product     (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of     thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange,     with a special emphasis on the occurrence of thromboembolic events (TEEs).   "
102966|NCT01938391|"     IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy     System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic     peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal     (POP), and/or Tibioperoneal Trunk (TPT).   "
102968|NCT01938365|"     primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and     youth.      secondary outcomes:        1. To classify diabetes by gene detection in Chinese adolescent and youth.        2. To make the relationship between genotype and clinic phenotype in type 1 diabetes.        3. To evaluate the effect of environmental factors (intestinal ecosystem)in the          pathogenesis of diabetes.   "
102969|NCT01938352|"     After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be     challenged with the H3N2 virus. The protective efficacy, safety, tolerability,     pharmacokinetics, and potential immunogenicity will be assessed.   "
102970|NCT01938339|"     To development of clinical assessment technique using multi-radiotracer positron emission     tomography/magnetic resonance (PET/MR) in prostate cancer        -  to establish the optimal imaging technique of PET/MR using multiple radioactive tracers          for prostate cancer        -  to establish the imaging biomarker using PET/MR for clinical assessment of prostate          cancer and early detection of recurrent prostate cancer   "
102971|NCT01938326|"     1. Compare the immune response and postoperative complications between pure SIDG          (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal          gastrectomy) for early gastric cancer (EGC)        2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)   "
102975|NCT01938274|"     To pilot test an activity-focused intervention that educates patients undergoing total hip     (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type,     frequency, intensity, and duration of expected leisure activities after surgery and to     determine if the intervention changed expectations.   "
102976|NCT01938261|"     Present randomized, controlled, double-blind trial investigates the efficacy and safety of     early (<24 h) intravenous paracetamol therapy for both the early closure of the ductus and     pain medication in very small premature infants. This phase 2 drug study focuses on the     efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of     paracetamol, as well as the long-term effects, are studied.      This study recruits preterm infants born less than 32 weeks gestational age and treated at     the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked     from all parents. The first drug dose is given before 24 hours of age. Masked study drug is     paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The     loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The     exact date of the closure of ductus is studied by repeated echocardiographic examinations.     The symptoms of pain are screened by a locally used pain scale of preterm infants (NIAPAS).     Patients are monitored for signs of possible side effects. After discharge from hospital,     patients are examined at follow-up clinic for the first year every 3 months and at 2 years of     age.   "
102977|NCT01938248|"     This study aims to determine if treatment with apixaban, compared with aspirin, will reduce     the risk of ischemic stroke and systemic embolism in patients with device-detected     sub-clinical atrial fibrillation and additional risk factors for stroke.   "
102978|NCT01938235|"     This study aims to assess the effect of exenatide on myocardial injury in patients undergoing     emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial     infarction or heart attack (STEMI).   "
102979|NCT01938222|"     A number of studies identifies abdominal hernia as the most frequent postoperative     complication following laparotomy with percentages of 9-20% - depending on duration of     follow-up. It is based on a multifactorial basis, including factors concerning individual,     patient-specific factors, factors related to the operational technique as well as particular     surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate     (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being     6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication     rate of up to 50 % has to be expected. According to new, first findings from recent studies     the rates of wound healing complication and burst abdomen can be reduced significantly.     Depending on the study, to almost 50%. The principle is based on the reduction of the stitch     length and type of the inserted suture. The stitches are closer and with less distance to the     edge of fascia. Due to the much thinner suture it still comes here to a quantitative     reduction of the inserted suture. The data collected using the MonoMax® suture in the short     stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax®     suture was used in the long stitch suture technique. The generated data are thus subject of     retrospective comparison with a historical control group (ISSAAC study).   "
102980|NCT01938209|"     Thirty-nine patients with cervical spine pain were randomly assigned to either a seated     thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion range     of motion measures were taken before and after the intervention.   "
102981|NCT01938196|"     The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in     chronic constipation patients.   "
102982|NCT01938183|"     Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers     volunteers could improve clinical parameters when compared to metronidazole tablets +     periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned     into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement     combined with daily topical application of 3 g metronidazole benzoate gel (15%); and     periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical     parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and     relative attachment level.   "
102983|NCT01938170|"     This study will examine the feasibility of having parents and caregivers administer FluMist     live intranasal vaccine to their children at home outside the traditional medical environment     and without the involvement of medical personnel.      The study will recruit patients and families that are already eligible to receive the FluMist     vaccine. After consent is obtained and vaccine is given to the family, they will go home to     administer vaccine to other members within 24 hours. Telephone follow up within 48 hours will     confirm that vaccine was given successfully and within 9-12 days to assess patient     preferences for giving vaccine at home and if there were any adverse events.   "
102984|NCT01938157|"     Purpose: The purpose of this pilot study is to evaluate whether MRI of the breasts with     diffusion-weighted MR imaging can identify features more specific for breast cancer in women     at high-risk of developing breast cancer.      Participants: One hundred asymptomatic women at high-risk for breast cancer recommended for a     clinical breast MRI identified through the UNC Breast Clinic will be consecutively recruited     for this study.      Procedures (methods): Each patient will undergo a clinical breast MRI and the addition of a     single 90 second diffusion weighted sequence. A reader study will be conducted at UNC after     the completion of patient accrual. The images will be analysed for lesions, enhancement     patterns, diffusion weighted imaging data and correlated with any pathology or 1 year     follow-up MRI exam. The study information will be entered into a secure database and     analyzed.   "
102985|NCT01938144|"     This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group,     comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine     (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms     of the common cold and flu. The reference product that the active treatments will be compared     to is paracetamol (PARA) 500 mg.   "
102997|NCT01937988|"     This study will be a non-blinded randomized controlled trial (RCT) of women presenting for     abortion at <13 6/7 weeks. Women will be randomized either to receive support by a trained     abortion doula (intervention) or to have standard procedure (control) during the abortion     procedure. The investigators hypothesize that women who receive doula support during a first     trimester abortion will report less pain during the abortion procedure compared to women who     do not receive abortion doula support.   "
102986|NCT01938131|"     The rehabilitation protocols in knee osteoarthritis are often difficult to be applied in     elderly patients because they are long lasting and need the constant participation of     patients. To rapidly improve the motor performances of patients it is possible to use the     mechanical vibration applied to individual muscles using a protocol called repeated muscle     vibration (rMV). The purpose of this single-blind randomized placebo-controlled study is to     evaluate the effectiveness of the repeated muscle vibration (rMV) in terms of increasing the     ability of the patients affected by knee osteoarthritis, compared to an ineffective     treatment, considered as a placebo. Each subject, randomly assigned to either the group 1     (study group) or placebo-treatment (group 2)is administered 3 daily applications of rMV of 10     minutes each, for 3 consecutive days. Between two successive applications it's observed a     break of at least 15 seconds. The probe of the specific instrument (Cro ® System) is placed     near the supero-medial margin of the patella, on both quadriceps. Patients in group 2     (control group) are subjected to a treatment with muscle released in which the probe of the     same instrument is approached to the quadriceps, without making contact. The instrument in     these conditions emits a buzz but not provokes muscle vibration. The primary outcome of the     study is to determine the changing in patients' ability (as measured by WOMAC scale = Western     Ontario and McMaster Universities Osteoarthritis Index) . The secondary outcomes of the study     are the assessment of changing of patients' balance and risk of falling (as measured by the     Tinetti scale) and assessment of changing of patients' quality of life (as measured by     EQ-VAS= EuroQuality of Life-VAS scale).Outcome measures are administered at baseline (T0), at     the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of     treatment and 6 months (T4) after the end of the treatment.   "
102987|NCT01938118|"     The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic     black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a     multi-component home visitation program, compared to an attention control (child safety) in     promoting appropriate weight gain during infancy.   "
102988|NCT01938105|"     The purpose of this study is to determine the feasibility and efficacy of preoperative     nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable,     locally advanced cervical cancer.   "
102989|NCT01938092|"     To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain     associated with pelvic floor hypertonic disorder.   "
102990|NCT01938079|"     In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide.     However, in patients with severe lung failure, blood may not adequately be delivered to the     lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may     require assistance from a machine to help provide this oxygen. Extracorporeal membrane     oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to     recover from their illness. Patients receiving support from ECMO are often put in a medically     induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the     machine; therefore leading to decreased concentrations. Patients receiving ECMO often require     high doses of both pain medications and sedatives in order to provide comfort. Low doses of a     drug, ketamine, may help to provide additive effects to pain relief and allow lower doses of     other pain medications. The hypothesis is that patients treated with continuous intravenous     ketamine, will have lower requirements of other pain medications while receiving ECMO for     acute respiratory failure while achieving the desired level of sedation.   "
102991|NCT01938066|"     The purpose of this study is to determine if Procellera speeds wound healing. The study will     examine colonization (bacterial growth), pain and pain medication and reduced cost of care by     using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the wound     after abdominal wall surgery. Procellera is a single layer dressing that helps to kill germs     that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that is     placed in your wound to help heal the wound faster.   "
102992|NCT01938053|"     The primary goal of this project is to improve the process for contacting patients that test     positive for a sexually transmitted infection (STI) in the emergency department by using text     messaging. We believe patients that are contacted by both a phone call and a text message     will be reached more often and they will be reached sooner than those that only receive a     phone call or only a text message. In addition, patients will be given reminder cards at the     time of testing to remind them that they will be contacted within 7 days if they test     positive. Half of the reminder cards will have a number to call for test results. We believe     patients that receive a card with a number are more likely to be contacted within 7 days.   "
103006|NCT01937858|"     The value of HbA1c as a tool to determine glycemic control in patients with diabetes and     renal failure has not been well studied, the same accepted normal ranges for HbA1c are     applied to all patients with diabetes regardless of their renal function. We would like to     evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup     of patients with diabetes and evaluate the effect of dialysis on HbA1c   "
103007|NCT01937845|"     Evaluating the health outcomes of patients that were enrolled in Joslin's Why WAIT Program.     These outcomes include BMI, A1C, lipid profile.   "
102993|NCT01938040|"     This study is being done because the investigators wish to study ways to improve recovery     after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the     body's attempt to protect itself and to start the healing process. Some surgical     complications are related to the body's natural inflammatory response. Although mainly a     healing response, inflammation can also have side effects which delay recovery. The     investigators wish to determine the effect of a medication known as ibuprofen on recovery.     You may know ibuprofen by the name Advil or Motrin. The medication will be given through the     vein prior to the start of the surgery. Three blood samples will be taken, two while the     patient is under anesthesia. The subject will be asked to complete several questionnaires.   "
102994|NCT01938027|"     The purpose of this study is evaluation of the safety and the efficacy of transanal total     mesorectal excision.   "
102995|NCT01938014|"     Hypothesis: Children diagnosed with a lysosomal disease will exhibit developmental, adaptive,     and behavioral strengths and difficulties depending upon 1) biomedical risk factors (i.e. the     specific genetic disorder responsible for the illness); 2) available modifying interventions,     whether medical or behavioral; and 3) social risks in the children's families, neighborhoods     and communities. A valid and reliable telephone-based surveillance system can successfully     collect the data required to elucidate these developmental, adaptive and behavioral strengths     and difficulties.   "
102996|NCT01938001|"     This double-blind randomized, parallel group study will evaluate the efficacy and safety of     lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients     with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be     randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination     with rituximab. Anticipated time on study treatment is 1 year.   "
102998|NCT01937975|"     Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of     combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic     (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with     end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal     impairment. Both groups were compared to healthy matched controls.   "
102999|NCT01937949|"     This study will compare two groups of subjects with complex abdominal aortic aneurysms. It     will compare their clinical outcomes and quality of life measures. The group being treated in     this study will have their aneurysms repaired by an endovascular approach using Zenith®     Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients     (historical cohort) whose complex aneurysms were treated by open surgical repair.   "
103000|NCT01937936|"     Family caregivers are vulnerable to health problems because of the stress and demands of     their role as a caregiver. With the growing incidence of heart failure (HF) and the     anticipated growth in the aging population, the number of HF caregivers is expected to rise.     This study will pilot test a cognitive behavioral intervention designed to reduce stress     among HF caregivers, which will ultimately contribute to promoting health and quality of life     among HF caregivers and their loved ones with HF.   "
103001|NCT01937923|"     This observational study will establish a clinical baseline and measure changes over time in     movement, thinking, behavior, brain imaging, blood and spinal fluid markers in subjects with     early stage Huntington's disease. Participants enrolled in this study may be eligible to     participate in a future planned study of stem cell therapy for Huntington's Disease (HD).      In-person study visits occur at screening, baseline, and every 6 months thereafter for a     minimum of 12 months, with interim phone call assessments.   "
103002|NCT01937910|"     The main goal of this research is to advance understanding of how stroke changes both the     structure and function of the brain. The investigators will determine which is the key driver     of recovery of arm function after stroke: changes in the structure of the brain or changes in     how brain regions interact with one another.   "
103003|NCT01937897|"     In depression, EEG studies have shown frontal asymmetry with relatively lower activity in the     left hemisphere. In this study a moderate pressure massage will be conducted by a trained     professional on one of the following conditions: the right side of the body, the left side of     the body, or both sides of the body (a traditional massage on the back of the body) while EEG     measurements of brain activity are recorded and mood ratings are obtained.   "
103004|NCT01937884|"     Optimal delivery of nutritional support during critical illness is central to appropriate     intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing,     route, dose, and type of nutritional support for critically ill infants and children.     Understanding how to optimize nutritional support during pediatric critical illness is     important because even brief periods of malnutrition in infancy result in permanent negative     effects on long-term neurocognitive development. Optimized nutrition support is a way to     improve morbidity for survivors of pediatric critical illness. Parenteral nutrition (PN)     supplementation could improve long-term neurocognitive outcome for pediatric critical illness     by preventing acute malnutrition, but has unknown effects on intestinal barrier function; a     proposed mechanism for late sepsis and infectious complications during critical illness.      While randomized controlled trials (RCT) support early PN in premature infants and late PN in     critically ill adults, the optimal time to begin PN is unknown for critically ill infants and     children. Acute malnutrition may develop within 48 hours of admission in critically ill     infants and children, and repleted energy stores are predictive of survival. And yet, due to     concerns for PN-associated infectious morbidity, current PICU standard of care is to     supplement with PN only in children who fail to enterally feed, as late as 7 days into their     admission. Delays in nutrition may have long-term effects on cognitive outcome in older     infants and children. In premature infants, PN begun within hours of birth results in     improved 18-month neurocognitive outcome without an increase in infectious complications. An     RCT is needed to determine if early PN in critically ill infants and children prevents acute     malnutrition and improves short and long-term outcomes of PICU hospitalization.      The central hypothesis of this proposal is that optimized early protein and calorie delivery     will improve nutritional outcomes and intestinal barrier function for critically ill infants     and children. The overall purpose of this study is to evaluate the efficacy and safety of     early PN as a supplement to enteral nutrition to improve nutritional delivery, nutritional     outcomes, and intestinal barrier function for infants and children with acute respiratory     failure who are mechanically ventilated in the pediatric intensive care unit.   "
103005|NCT01937871|"     The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in     men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract     Symptoms (BPH-LUTS) and improve their quality of life.   "
103008|NCT01937832|"     The purpose of this study is to evaluate the safety and Efficacy of Faropenem in     community-acquired pneumonia (CAP) subjects   "
103011|NCT01937793|"     This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise     programs for patients with NPC after radiation therapy. This study also compares two     different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one     can bring more benefits to patients after a certain period of exercise training. Three     assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing     Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing     Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the effortful     swallowing exercise would have better treatment efficacy.   "
103012|NCT01937780|"     This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal     cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The     utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be     investigated. Molecular and genetic markers in tumor and blood will be analyzed for     prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence,     sexual dysfunction and quality of life will be assessed. A structured intervention program     for management of late effects will be evaluated. Symptom relief of palliative radiotherapy     will be investigated. The main purpose of the study is to increase the knowledge of anal     cancer treatment, improve treatment results, and improve anal cancer survivor care.   "
103013|NCT01937767|"     This phase II study in patients undergoing elective cardiac surgery will evaluate the     efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and     sevoflurane, during the induction and maintenance of general anesthesia.   "
103014|NCT01937754|"     Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy     adults with clinical prehypertension.   "
103015|NCT01937728|"     The purposes of this study are:        1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to          standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and          HVL        2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is          superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at          week 12   "
103036|NCT01937455|"     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of     rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male     adults.   "
103016|NCT01937715|"     This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal     carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus     FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of     PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.      The study population will consist of patients with mCRC previously treated with an     oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of     the end of an adjuvant oxaliplatin-based regimen.   "
103017|NCT01937702|"     A trial, investigating the influence of injection speed and volume on the perception of     subcutaneous injection pain.   "
103018|NCT01937689|"     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This     study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2     positive advanced breast cancer:        -  To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose          (MTD)        -  To determine the dose-limiting toxicity (DLT)        -  To determine the pharmacokinetic profile of Pyrotinib and its metabolites        -  To assess preliminary antitumor activity        -  To determine preliminary regimen dose for phase II study        -  To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.   "
103019|NCT01937676|"     The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the     emergency department can be used to predict the development of organ failure measured as SOFA     score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.   "
103020|NCT01937663|"     The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in     chronic constipation patients.   "
103021|NCT01937650|"     The objective of the study was to determine whether there was a difference in the     effectiveness of Radiotherapy alone compared with Radiotherapy plus Metronidazole in the     treatment of women with advanced cancer of the cervix in Mulago hospital. It was a randomized     controlled trial composed of 38 women altogether, with one group composed of randomly     selected women with advanced cancer of the cervix treated with radiotherapy alone and the     other group composed of similar women but treated with radiotherapy and metronidazole.   "
103022|NCT01937637|"     Many individuals with lung cancer experience debilitating breathlessness at some point during     the course of their illness. Unfortunately, few interventions exist to treat this distressing     symptom of cancer.      In this study, the investigators plan on recruiting individuals with lung cancer to     participate in a behavioral intervention to help relieve breathlessness. The principal     investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has     trained nurse practitioners in how to deliver the behavioral intervention. The nurse     practitioners will meet with patients diagnosed with lung cancer during their outpatient     oncology appointments, such as chemotherapy infusions, to review the behavioral skills that     may help with breathlessness. Specifically, the intervention includes education about the     relationship between breathlessness and the stress response as well as teaches patients     skills for breathing control and relaxation of the body.      For this single-group pilot study, the investigators will ask participants to provide     feedback about whether they found the intervention acceptable and effective. Participants     will also complete questionnaires about their physical and psychological symptoms before and     after the intervention in order to measure its effectiveness for treating breathlessness and     any distress related to breathlessness. The data from this study will help inform     improvements to the intervention in order to make it feasible and effective for treating     breathlessness in patients with lung cancer.   "
103023|NCT01937624|"     The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic     musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting.     Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound     will be compared to x-ray diagnosis under routine conditions in the investigator's injury and     fracture treatment evening clinic. Data will be collected and recorded during the duration of     the 12 week study. Through the literature review and experience with ultrasound, the     investigators anticipate that diagnostic ultrasound will provide very high sensitivity and     specificity in diagnosing distal radius fractures in children.   "
103024|NCT01937611|"     Many studies have been conducted for the feasibility of using dexmedetomidine as     premedication. However, bradycardia and hypotension frequently occurred following the     premedication with dexmedetomidine, either via intramuscular or intravenous route. This is     particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2     μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and     mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further     revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes.     Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding     study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular     dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However,     few investigations have addressed the clinical effects of low-dose dexmedetomidine as     premedication. Considering modern anaesthesia has advanced a long way towards eliminating the     routine need for a deep preoperative sedation. It has, therefore, become desirable to asses     dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its     undesired hemodynamic effects. We set a prospective study to compare the sedative,     haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose     dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used     premedication, used as an intramuscular injective administration in patients undergoing     suspension laryngoscopic surgery under general anaesthesia.   "
103025|NCT01937598|"     Objectives: To quantify differences in control of glycemia (primary objective) and the     secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or     placebo added to pre-existing therapy with liraglutide and metformin   "
103026|NCT01937585|"     The purpose of this study is to determine whether female partners of African American men can     promote initiation of a discussion with a healthcare provider about prostate cancer screening     when the partner is supported by a print message designed to provide relevant information and     strategies for her to use in this effort.   "
103037|NCT01937442|"     Objective of this study is to characterize the steady-state pharmacokinetics (PK) of     thalidomide when given orally as monotherapy to subjects with multiple myeloma.   "
103027|NCT01937572|"     The purpose of the current study is to validate the technology of MRI-based alignment for     total knee replacements and to collect data on potential advantages of the computer aided     system.        1. It is hypothesized that there will be no significant differences in position, loosening,          or function of the Visionaire total knee as compared to the conventional total knee.        2. It is hypothesized that the Visionaire total knee will be significantly better with          regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover          time, and overall costs.   "
103028|NCT01937559|"     The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in     decreasing blood loss following both shoulder arthroplasty and primary total hip     arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system     within the body. The investigators hypothesize that topical application of TXA prior to     closure reduces postoperative bleeding as measured by absolute changes in postoperative     hemoglobin levels and surgical drain output. In addition, use of topically applied     tranexaminic acid may reduce the need for transfusions, the rates of hematomas, infections,     and length of hospital stay.   "
103029|NCT01937546|"     It is unknown if primary delivery of the anterior or the posterior shoulder causes less     perineal tear. The objective of this trial is to evaluate the incidence and degree of     perineal trauma after primary delivery of the anterior shoulder compared to primary delivery     of the posterior shoulder during vaginal birth in primiparous women in a randomized     controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces     the rate and degree of perineal trauma.   "
103030|NCT01937533|"     This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance     Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil     has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS     Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI     at 3T can be used to differentiate different histological characteristics within whole     tumours and so determine if the technique could be of prognostic value.      The study hypothesis is that this technique will be able to differentiate tumours with     histological features known to be associated with poor prognosis (tumour type, grade and     lymphovascular space invasion).   "
103031|NCT01937520|"     This study is being done because the investigators wish to study ways to improve recovery     after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the     body's attempt to protect itself and to start the healing process. Some surgical     complications are related to the body's natural inflammatory response. Although mainly a     healing response, inflammation can also have side effects which delay recovery. The     investigators wish to determine the effect of acupuncture on post-operative surgical pain. An     increase in pain after surgery can cause distress for patients. Acupuncture is an alternative     medicine methodology originating in China that treats patients by manipulating thin, solid     needles that have been inserted into acupuncture points in the skin. Acupuncture has been     used for the reduction of pain. The investigators would like to see if acupuncture during     surgery can provide a lower level of pain, reduced pain medication requirement, and a lower     incidence of nausea and vomiting.   "
103032|NCT01937507|"     Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or     liver-predominant metastases who have failed at least one line of systemic chemotherapy in     metastatic setting.   "
103033|NCT01937494|"     Bronchial hyperresponsiveness consists in excessive response to bronchial stimuli.Bronchial     challenge test is used to confirm/exclude asthma (metacholine or histamine).Protection are     used to avoid passive exposure of the technicians performing the test, despite the absence of     evidence that they could develop a bronchoconstriction even if they suffer from BHR.The     purpose of the study is to determine if patients with a high level of bronchial     hyperreactivity and exposed passively to histamine during a bronchial challenge, are     developing a bronchoconstriction, when placed in the same conditions that the technicians     performing these tests.   "
103046|NCT01937325|"     Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation.     Improvement in ventilation, salt balance and well-being will contribute to better exercise     capacity at all levels of lung function. While potential improvements may be variable across     the spectrum of lung function, even small gains at low levels of FEV1 may have significant     benefit for some subjects.   "
103034|NCT01937481|"     The Colorado Longitudinal Eating And Physical activity (LEAP) Study utilizes a social     ecological approach to explore individual, family and environmental factors and their     relationship to child weight status over a 3 year timeframe. Our primary research questions     are as follows:        1. Are behavior changes (increased willingness to try new foods and gross motor skills)          from a preschool nutrition and activity program, The Food Friends®, sustained through          early elementary school?        2. Do The Food Friends® programs have an impact on reducing the percentage of children          considered overweight and/or obese over a 3 year timeframe?        3. Do food preference and gross motor performance directly affect child weight status or          are they mediators to dietary intake and physical activity?   "
103035|NCT01937468|"     This research study is a Phase I clinical trial, which tests the safety of an investigational     combination of IL-2 plus donor anti-inflammatory Treg cells and also tries to define the     appropriate dose of the investigational combination of IL-2 plus donor anti-inflammatory Treg     cells to use for further studies. IL-2 is involved with cell signaling and regulation of     white blood cells (WBCs). WBCs are part of the immune system. Treg cells are also part of the     immune system; they are involved with anti-inflammatory responses. Investigational means     that the combination of IL-2 and anti-inflammatory Treg cell infusion is being studied. It     also means that the FDA (U.S. Food and Drug Administration) has not approved the combination     of IL-2 and anti-inflammatory Treg cell infusion for use in people with cGVHD.      Chronic GVHD is a medical condition that may occur after you have received your bone marrow,     stem cell or cord blood transplant from a donor. The donor's immune system may recognize your     body (the host) as foreign and attempt to 'reject' it. This process is known as     graft-versus-host disease.      Traditional standard therapy to treat cGVHD is prednisone (steroids). Participants on this     trial have not responded to steroid therapy. The investigators are looking to assess the     safety and optimal dose for the combination of IL-2 plus donor anti-inflammatory Treg cells,     that may help control cGVHD by stopping the donor's immune system from 'rejecting' your body.   "
103038|NCT01937429|"     The colonoscopy is the reference examination for the diagnosis of neoplastic lesions in the     colon and rectum. Mass screening assessment studies have shown that colonoscopic detection     and removal of adenomas in patients selected through fecal occult blood test reduces     colorectal cancer incidence and mortality. However, the literature has reported interval     cancer cases or adenomas, probably missed by the colonoscopy. In theory, using coloured     warm water could improve colon preparation by mobilizing the residual faeces, decreasing the     colic spasm and increasing the visualization of the pit pattern. Preliminary American     studies, led by Leung et al, have shown a very clear increase in the adenoma detection rate.      The investigators' study involves 1 000 patients, treated in the Rhône-Alpes / Auvergne     region. The patients present an indication for colonoscopy following a positive fecal occult     blood test or symptoms or personal and family histories of pre-cancerous colonic lesions.     They will be randomized into two study groups:one of both groups of study: Group 1: patients     undergoing a colonoscopy wtih instillation of tepid water tinged with blue (Indigo Carmin®)     Group 2: patients undergoing a standard colonoscopy with insufflation of air. The main     objective is to show that the colonoscopy with blue water (Indigo Carmin®) enable detection     of more lesions than standard colonoscopy with insufflation of air. The two techniques will     be also compared in terms of tolerance, of duration of colonoscopy and type of detected     lesions.      In case of improved detection of colorectal lesions, the blue water instillation technique of     could dramatically change gastroenterologists' practice by becoming the reference method. The     expected clinical benefits are potential revealing of more neoplastic lesions and improvement     in abdominal discomfort after colonoscopy.   "
103039|NCT01937416|"     This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear cells     transplantation in diabetic patients with lower limb ischemia.   "
103040|NCT01937403|"     The primary purpose of this study is to determine the interrater reliability and validity of     the Sportcord Test as a measure of physical performance following anterior cruciate ligament     (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective     outcomes on patients following ACL reconstruction to help identify differences between those     who have subsequent knee problems and those who do not. The study hypotheses are the     following:      1) The Sportcord Test will provide a valid and reliable measure of functional performance     following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month     study period will exhibit different scores on clinical special tests compared to those who do     not.   "
103041|NCT01937390|"     The objective of the study is to observe the effect of adherence to once-daily administered     long-acting bronchodilators (long-acting ß2-agonists [LABAs] / long-acting muscarinic     antagonists [LAMAs]) on patients health related quality of life (HR-QoL) and to assess the     relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease     (COPD) maintenance therapy   "
103042|NCT01937377|"     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at     risk for stroke are enrolled to characterize the target population and to collect real world     data on important outcome events. For administrative purposes the study is divided into three     protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic     Area) countries, 1160.136 for EU and EEA countries and 1160.171 for India and Switzerland.     The total number of patients enrolled in three protocols is estimated to be 48,000 patients,     and all these patients will be included in the data analysis for study 1160.129.   "
103043|NCT01937364|"     The purpose of this study is determine if the medication baclofen can prevent the symptoms of     Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This     medication is most often used for patients who have spasticity of their muscles due to a     neuromuscular disease. In several European studies, and in an earlier study at Essentia     Health (NCT00597701), baclofen has been found to have a significant effect on the severity of     symptoms of AWS.   "
103044|NCT01937351|"     A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an     atherectomy device that provides directional visualization and imaging as an adjunct to     fluoroscopy to aid removal of plaque in diseased lower extremity arteries.   "
103045|NCT01937338|"     Study to investigate the effect of a single dose of AZD7624 on inflammation caused by an     endotoxin challenge.   "
103049|NCT01937286|"     Within community with high incidence of HCC, stretching the limits could be justified based     on tumor characters and its biological behavior   "
103050|NCT01937273|"     Cancer patients are one of the patient groups at highest risk for the development of     malnutrition. Anti-cancer treatments, such as chemotherapy and radiotherapy, can further     heighten the risk due to the nutrition-related toxicities experienced during this time.      This study aims to baseline the nutritional status of chemo-radiotherapy patients undergoing     treatment at the Alan Walker Cancer Care Centre (Darwin), identify contributors to     nutritional deterioration and determine if there is a difference between Indigenous and     non-Indigenous patients.   "
103051|NCT01937260|"     This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in     subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of     brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects     with moderate to severe plaque psoriasis.   "
103052|NCT01937247|"     The main purpose of the study is to examine whether operating room (OR) efficiency will be     improved by significantly decreasing non operative time. This study also aims: 1) to evaluate     whether a decrease in non-operative time will result in increased surgeon and staff     satisfaction, 2) to determine whether there is an increase in the complication rate during     the redesigned process perioperatively and until discharge from the post anesthesia care     unit, and 3) to rate patient satisfaction.   "
103053|NCT01937234|"     Reducing the length of labor is a highly desirable goal of intrapartum care, both from a     perspective of maternal and fetal well-being , and for the providers of the birth services.     Avoiding a long , protracted labor entails shorter exposure to pain anxiety and stress and     would translate into a major improvement in maternal satisfaction with the child birth     experience.      The purpose of this study is to determine the effectiveness of metoclopramide for reducing     the duration of spontaneous labor among nulliparous women managed according to a standard     intrapartum protocol.   "
103054|NCT01937221|"     The goal of this study is to create new retinal imaging processing software useful for the     development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's     disease (AD).   "
103081|NCT01936844|"     Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human     interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure     with the aim to quench the acute inflammatory response, as measured by the     area-under-the-curve for C reactive protein over 14 days.   "
112660|NCT01811303|"     The purpose of this study is to determine whether D-fagomine affects glycaemic responses to     sucrose (commercial white sugar)and quantify the response   "
103055|NCT01937208|"     Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with     localized carcinoma of the esophagus selected for nonsurgical treatment. The standard     radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology.     Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend     radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III,     randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent     chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal carcinoma.   "
103056|NCT01937195|"     The study will test a hypothesis that the AccuCath™ System will have a higher rate of     successful first attempt peripheral intravenous (PIV) placement, higher completion of     therapy, fewer complications, longer dwell times, and higher user satisfaction compared to     Conventional IV Catheters.   "
103057|NCT01937182|"     We wish to conduct a prospective, randomized, double blind, placebo controlled multi center     study of the combined neuroprotective and antithrombotic effects of SSRI treatment after     stroke.      Hypotheses:      SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new     thromboembolic events and leads to better rehabilitation. 600 stroke patients will be     randomized in a 1:1 ratio.      The treatment and follow up period is 6 months. During these 6 months there will be 2     clinical follow up visits, one telephone control and one visit to evaluate compliance     regarding medication.   "
103058|NCT01937169|"     Neurons in the brain require blood and oxygen for proper function. The term neurovascular     coupling has been postulated in the 19th century by Roy & Sherrington referring to increased     blood flow to active neurons. The rationale of this research relies on the neurovascular     coupling, suggesting that increased blood flow to active regions on the brain should supply     not only more blood, but also more of a pharmacological agent present in the blood system at     the time. Thus, active regions should be affected by the agent (=drug) to a greater extent.      In the present study we focus on the dopaminergic system, critical in many functions such as     cognition, response to stimuli and movement. One of the well-known dopaminergic pathways in     the brain is the nigrostriatal pathway, mediating motor function. In this research, we intend     to examine the effects of coupling functional activation in this pathway with a dopaminergic     agent, Carbidopa/Levodopa, on symptoms of Restless Leg Syndrome (RLS). RLS is characterized     by an irresistible urge to move the limbs (i.e. Akathisia), and results most prominently by a     significant decrease in the quality of sleep. Our research focuses on this symptom of RLS to     examine the effect of coupling brain activation and drug treatment.      The first line of treatment in RLS is dopaminergic drugs. These drugs increase dopamine     levels in motor pathways, and our research will aim to couple activation in the nigrostriatal     motor pathway with dopaminergic treatment in RLS. Functional activation will be achieved with     a simple motor task, known to elicit activation in the nigrostriatal pathway. We hypothesize     that the drug will act upon the pre-activated motor system, and that this coupling between     brain activation and drug treatment will ameliorate sleep-related symptoms of RLS, compared     with treating these symptoms solely with a dopaminergic drug and compared with using a     non-motor task.   "
103059|NCT01937156|"     The purpose of this study is to assess the efficacy and safety of SP-01 in     chemotherapy-induced nausea and vomiting (CINV) associated with the administration of     moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide     scientific and reliable clinical data in the drug registration in China.   "
103060|NCT01937143|"     Immunization injections are the most common recurring painful medical procedure undertaken in     childhood. Numerous evidence-based and feasible interventions are available to mitigate     immunization pain, however, there is low uptake of these interventions in clinical practice,     revealing a knowledge-to-care gap between what is known about pain and pain management. This     is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420     mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in     Toronto. The trial will evaluate and compare the impact of two levels of intensity of     maternal education about pain management during infant immunizations ('low': pamphlet vs.     'high': pamphlet + video) compared to placebo control after the birth of an infant on     maternal behaviour during future infant immunizations at up to 6 months of age (use of     analgesic interventions), maternal knowledge and attitudes about pain and pain management up     to 6 months after birth.   "
103061|NCT01937130|"     The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary     efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more     than 24 hours due to acute deterioration of liver function.   "
103062|NCT01937117|"     This research is being done to determine if early changes on a type of imaging procedure     called PET (Positron Emission Tomography) can predict which patients are most likely to     respond to the combination of trastuzumab and pertuzumab when given prior to surgery.   "
123943|NCT01663467|"     The purpose of this study is to prove the efficacy of the internet and smartphone     application-delivered tinnitus retraining therapy (TRT).   "
103063|NCT01937104|"     Increase of intracerebral pressure (ICP) during laparoscopic surgery has known to be     associated with positional changes. Optic nerve sheath diameter (ONSD) has correlation with     ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a     noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to     investigate the change of ONSD according to the positional change during laparoscopic     surgery.   "
103064|NCT01937091|"     Purpose: To comprehensively explore the barriers and motivators for participation in HIV     clinical trials in a purposive sample of HIV positive patients receiving care at the UNC ID     (Infectious Diseases) clinic Participants: HIV positive patients seen at the UNC ID Clinic.     Participants will be purposively sampled based on gender, race and previous participation in     HIV clinical trials. Blacks and patients who have never participated in clinical trials will     be oversampled.      Procedures (methods): Cross-sectional study using in-depth semi-structured qualitative     interviews to determine the barriers and motivators for participation in HIV clinical trials.     Patient interviews will be audiotaped, transcribed verbatim and analyzed using Atlas.ti     software to understand the barriers and motivators for participation in HIV clinical trials.   "
103089|NCT01936740|"     The aim of this study was to compare the intraoperative efficiency, safety and postoperative     outcomes of cataract surgery with two different high-fluidic settings.   "
103090|NCT01936727|"     The aim of this study was to compare the intraoperative efficiency, safety and postoperative     outcomes of cataract surgery with two different high-fluidic settings.   "
103091|NCT01936714|"     The aim of this study was to compare the intraoperative efficiency, safety and postoperative     outcomes of cataract surgery with two different high-fluidic settings.   "
103479|NCT01931644|"     At Sanguine, we consider ourselves the bridge between patients and researchers striving to     find new treatments and diagnostics for numerous medical conditions. We collect biospecimens     like blood for medical researchers. Donate from your home, track your sample, and help     advance medical research.   "
103065|NCT01937078|"     Levodopa-induced dyskinesia is a common problem in Parkinson's disease (PD). In particular,     targeting non-dopaminergic systems may be an option for reducing dyskinesia without worsening     motor symptoms. One such target may be histamine. The central histaminergic system is     involved in diverse biological functions including thermoregulation, eating, and sleep; a     role in motor activity is suggested by strong histaminergic innervation of the basal ganglia.     Histamine H2 receptors are highly expressed in the striatum, particularly on the GABAergic     striatal-pallidal and striatal-nigral pathways Histamine H2 stimulation modulates     acetylcholine release. Previous studies have demonstrated that blocking acetylcholine with     anticholinergic agents can induce chorea. The investigators propose that histamine H2     receptor stimulation decreases acetylcholine in the striatum and increases activity of the     direct striatal output pathway, a key component of the neural mechanisms underlying     dyskinesia.      The investigators hypothesise that H2 antagonists would reduce activity of the direct     striatopallidal pathway and so potentially reduce levodopa-induced chorea      Famotidine has also been assessed in schizophrenia in a small cases series to treat     schizophrenia, with tolerability. Clinical experience thus suggests the suitability of using     this agent as a histamine H2 antagonist in clinical studies for PD.   "
103066|NCT01937065|"     Study of heterogeneity in associations between social deprivation and the initial     presentation of 12 cardiovascular diseases.   "
103067|NCT01937052|"     The purpose of this project is to establish a repository of information and samples from     breast cancer patients or those at high risk of developing breast cancer, who are initiating     hormone therapy as part of standard clinical care or prevention. This repository will include     patient reported outcomes and other questionnaires, information on medication use, data about     adherence to the hormone therapy and tumor characteristics, including prospectively collected     samples.   "
103068|NCT01937039|"     The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the     research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators     affiliated with it - to develop a repository of specimens with corresponding characteristics     from patients seen in the breast care and cancer clinics.   "
103069|NCT01937026|"     The purposes of this study are to assess how the body handles baricitinib when it is given     with another drug called probenecid. The study doctor will measure the amount of baricitinib     that is absorbed into the blood stream and the time that it takes to remove baricitinib from     the body. The safety and tolerability of these drugs will be studied. The study will last     about 18 days from the first dose to the end of the study (not including screening).   "
103070|NCT01937013|"     This study will evaluate the effects on emotions and neural activity of a one time dose of     intranasal oxytocin vs. placebo in patients with FTD and healthy controls.   "
103071|NCT01936974|"     To evaluate progression-free survival with two chemotherapy regimens on     platinum-resistant/refractory ovarian and peritoneal carcinoma   "
103072|NCT01936961|"     The purpose of this study is to use Immunochemotherapy +/- Hypofractionated Radiation for     complete response in solid tumors   "
103073|NCT01936948|"     The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the     detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of     transition to cancer increases with polyp size, effective and safe resection of large polyps     is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal     resection (EMR) using electrocautery snares. Resection of these large polyps is associated     with a risk of severe complications that may require hospitalization and additional     interventions. The most common risk is delayed bleeding which is observed in approximately     2-9% of patients. A recent retrospective study suggests that closure of the large mucosal     defect after resection may decrease the risk of delayed bleeding. However, significant     uncertainty remains about the polypectomy techniques to optimizing resection and minimizing     risk. Important aspects that may affect risk include clipping of the mucosal defect and     electrocautery setting.   "
103074|NCT01936935|"     The aim of this trial is to evaluate the effects of dairy product consumption on insulin     sensitivity and pancreatic β-cell function in men and women at risk for the development of     type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet     sodas and fruit juice cocktails).   "
103075|NCT01936922|"     A virtual reality device has already been successfully used for improving gait in adults who     have neurological conditions. We will evaluate if it is feasible to study the brief use of     this device in older adults who have had falls.   "
103076|NCT01936909|"     The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1     blocker) in patients with recently decompensated heart failure to determine the safety and     efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a     cardiopulmonary exercise test.   "
103077|NCT01936896|"     Acute myocardial infarction is characterized by an intense inflammatory response.      The degree of the response influences clinical outcome, with 'more' inflammation promoting     heart failure. In this study we plan to determine whether treatment with plasma derived     alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment     elevation myocardial infarction (STEMI).   "
103078|NCT01936883|"     Optimal non surgical treatment of prostate cancer requires dose escalation which is     frequently provided by adding a brachytherapy boost to a short course of external beam     radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR)     brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA)     recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that     it is associated with a more favorable toxicity profile and improved quality of life.   "
103079|NCT01936870|"     The purpose of this study is to collect effectiveness and safety information of fesoterodine     related to their appropriate use in daily practice.   "
103080|NCT01936857|"     The purpose of this study is to compare two models of substance abuse treatment in Vietnam,     and how they each affect HIV care. In Vietnam, the current model for treating people with HIV     who are also dependent on opioids is to refer them to methadone maintenance treatment     centers. The new model the protocol will study is treatment of HIV and opioid dependence with     buprenorphine/naloxone and counseling in the HIV clinic.   "
113477|NCT01800591|"     The goal of this study is to compare a novel approach using financial incentives to changes     in health benefit design and their impact on employee weight loss.   "
103082|NCT01936831|"     Isoniazid (INH) is a drug commonly used to treat TB worldwide. Sometimes, the bacteria that     cause TB can become resistant to INH. Resistance means that bacteria have adapted to a drug     and are able to live in the presence of the drug. When TB becomes resistant to INH, INH does     not work as well at fighting the bacteria. This study will treat people with INH-resistant TB     with different doses of INH to see if INH can still fight the bacteria if we just increase     the dose. We will compare how well the drug works at higher doses for participants who have     resistant TB to how well the drug works at regular doses for participants who have TB that is     not resistant. The study will also compare the safety and tolerability of the different doses     of INH. Tolerability is how well people can put up with the side effects of a drug. Using     increased doses of INH to treat TB that is resistant to INH is experimental and has not been     approved by regulatory authorities. While there is some evidence that this approach will     work, this has not yet been proven.      This study will be done in two stages. Stage 1 is a pilot study to determine the feasibility     of enrolling enough participants into Stage 2, the larger stage of this study. If Stage 1 is     successful, then Stage 2 will begin.   "
103083|NCT01936818|"     A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal Allergen     Challenge (NAC) in a Dust Mite Population   "
103084|NCT01936805|"     The aim of the present study was to evaluate the effect of pre-procedural single high loading     dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite     of death or myocardial infarction from cardiovascular (CV) causes, target vessel     revascularization (TVR), or stroke.   "
103085|NCT01936792|"     The purpose is to use Diffusion Kurtosis Imaging (DKI), Diffusion Tensor Imaging (DTI) and     resting state functional MRI to examine tissue damage in the brains of people who have had a     concussion, both acute and 3 months after the accident. A secondary purpose is to examine     whether the results of the scans are associated with physical, cognitive and emotional     problems after concussion.      It is hypothesized that there will be a change in the diffusion signal measured with DKI in     the thalamus (THA) and with DTI in the corpus callosum (CC), in the acute stage and at     follow-up of the mTBI subjects compared with the healthy controls. Secondary it is expected     that there will be changes in the diffusion signal measured with DKI and DTI in other WM and     GM area in both the acute stage and at follow up with mTBI subjects compared with healthy     controls. Also rs-fMRI markers are secondary expected to differ in the two groups. Moreover     secondarily the MRI markers are tested for correlation with the severity of PCS acutely and     at follow up after mTBI.   "
103086|NCT01936779|"     High levels of fatty substances in the blood increase the risk of developing heart disease.     Investigators know a lot about one of these fatty substances, cholesterol. However, there is     another fatty substance in the blood called triglyceride. Investigators do not understand     much about what regulates the rate at which the liver produces triglyceride and liberates it     into the bloodstream after eating a meal(s). It is known that taking fish oil lowers the     amount of blood triglyceride however, it remains unclear how this happens. Investigators will     study if changes in liver fat metabolism, after taking fatty acids found in fish oil (n-3     fatty acids)can explain the lowering of blood triglyceride. Investigators also want to know     if taking fish oil alters the amount of fat that accumulates within the liver.   "
103087|NCT01936766|"     Optimal fluid therapy in severe falciparum malaria has not been well defined, especially in     resource poor settings where access to mechanical ventilation is limited. Recent studies     suggest that liberal fluid resuscitation is harmful for severe malaria patients despite they     often being hypovolemic on admission. In order to elucidate the minimum fluid therapy     required to prevent complications in severe malaria, we will conduct a prospective     observational study in adults with severe malaria, and also in adults with severe sepsis as a     comparison group. The objective of this study is to describe the association between     hemodynamic variations in conventional fluid management and the probability of developing     acute kidney injury (AKI) or pulmonary edema in adults with severe malaria and severe sepsis.     Hemodynamic measurements will be obtained by using transpulmonary thermodilution and arterial     pulse contour analysis.   "
103100|NCT01936597|"     This study must evaluate the benefit of a continuous audio guidance on the effectiveness of     MCE directed by a volunteer.      The evaluation of the MCE for this study is based on both quantitative criteria (based on the     recommendations ERC 2010)        -  frequency        -  depth of chest compressions.      This study compares two methods of continuous audio guide (one arm with an audio continuous     guidance method by the regulator and second arm with an audio continuous guidance method by     the controller relayed by an audio) to a method of incentive MCE based on a unique set made     by the regulator(control arm).   "
103200|NCT01935284|"     To assess the interchangeability and agreement between measurements from three blood gas     syringes for the collection of blood for the analysis of multiple analytes as measured by     differing manufacturers' multi-parameter analyzers.   "
127865|NCT01611415|"     A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions     between furosemide and ipragliflozin (ASP1941) in healthy volunteers.   "
103088|NCT01936753|"     Nigeria has significant challenges in the delivery and coverage of PMTCT (Prevention of     mother-to-child transmission of HIV) services. Only 30% of pregnant women living with HIV are     provided anti-retroviral drugs for PMTCT. Less than 10% of HIV-exposed infants receive HIV     testing for early diagnosis by age 2 months. Furthermore, an unacceptably high number of     women with HIV who are enrolled in PMTCT programs do not complete them. In other words,     uptake and retention in PMTCT programs in Nigeria is not adequate. Ultimately,     mother-to-child transmission of HIV is high, resulting in a high number of new child HIV     infections.      Mentor Mothers (MMs) are women living with HIV who provide peer support to other HIV-positive     women. MM programs have been incorporated into PMTCT programs in several African countries     with some success, but with varying levels of MM training and program structure. The MoMent     (MOther MENTor) study investigates whether highly-structured MM programs will further improve     uptake and successful completion of PMTCT services (eg testing and appointments) in Nigeria.     The study also evaluates the impact of structured MM programs on other outcomes, including     facility deliveries, new infant HIV infections, infant survival and maternal viral     suppression. Rural areas are the focus of this study because of their particularly poor     performance in PMTCT coverage and outcomes.   "
130330|NCT01579084|"     This study will evaluate the safety and tolerability of AGN-199201 for the treatment of     erythema associated with rosacea.   "
103092|NCT01936701|"     Age-related cataract is the main cause of impaired vision in the elderly population     worldwide.      The only treatment that can restore functional visual ability is cataract surgery where the     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular     lens is implanted into the remaining capsular bag. Cataract operations are generally very     successful, with a low risk of serious complications.      The most common reason for impaired vision after uneventful cataract surgery in otherwise     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a     physiological change (thickening, opacification and clouding) of the capsular bag expected     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that     uses a laser to open a central hole in the posterior capsular bag.      Modifications in IOL design and material lead to a decrease in the incidence of PCO.      During the past two decades, refinements in surgical technique were made resulting in today's     small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are     available, many of them similar but of course with some differences in regard to the chemical     composition of the acrylic material and the IOL design.      The purpose of this study is to compare the development of posterior capsule opacification     (PCO) and the frequency of treatment between two different microincision IOLs over a period     of 2 years.   "
103093|NCT01936688|"     This study is being conducted to evaluate the efficacy and safety/tolerability of SCH     900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis.   "
103094|NCT01936675|"     This study is being done to better understand how genetic information might improve     assessment of heart attack risk.   "
103095|NCT01936662|"     Esophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients     undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or     without associated biopsies, is relatively short in length. Unlike adults, who regularly     undergo this procedure with conscious sedation, children most often require general     anesthesia. While safe and effective, endotracheal tracheal tube (ETT) intubation of children     for EGD can result in delayed awakening and slow room turnover, particularly when intravenous     medications are required for intubation. Laryngeal mask airway (LMA) is an alternative to     intubation, which permits removal before full awakening.      Although considered a safe alternative to tracheal intubation in appropriate cases,     disadvantages of the LMA have been reported including kinking, occluding view of the surgical     field, failure of placement requiring tracheal intubation, aspiration of gastric contents,     desaturation, and laryngospasm. The study was designed to determine whether use of an LMA for     EGD could reduce operating room time, while providing satisfactory conditions for the     endoscopist, and an equivalent side effect and safety profile as compared to ETT in otherwise     healthy children with gastrointestinal complaints   "
103096|NCT01936649|"     The aim of the study was to assess the reproducibility of quantitative measurements of     myocardial uptake of Iobenguane I 123 on planar and single photon emission computed     tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy     was assessed based upon the absolute differences between quantitative analyses of imaging     data on 2 scans performed 5 to 14 days apart.   "
103097|NCT01936636|"     This Observational Registry study is designed to collect self-reported Transmucosal Immediate     Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access     program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of     treatment with Abstral® through the use of Quality of Life and pain measurement tools     administered via questionnaire.   "
103098|NCT01936623|"     The purpose of the study is to determine whether a computerized brief intervention for     moderate risk drug use among adult primary care patients is more effective than providing     such patients with a substance abuse assessment alone.   "
103099|NCT01936610|"     In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week     were selected using multi-stage sampling and assigned into two groups randomly.     Decision-making (before, two weeks after and at admission in maternity department) was tested     by a researcher -made questionnaire. In experiment group, advantages and disadvantages of     normal delivery and cesarean-section delivery were presented by role-playing in three 90-min     scenarios. It was also presented in a 90-min lecture. Data were analyzed using SPSS by mean     difference test, exact fisher test, independent t-test and paired t-test.   "
103225|NCT01934946|"     Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no     adequate rehabilitation was given. The aim of the study is to compare the effectiveness of     different types of post acute rehabilitation care for hip fracture.   "
103101|NCT01936584|"     A multicenter observational study trial validating Quality of Life assessment using EuraHS     Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic     unilateral inguinal hernia repair.      Depending on the treating physician patients will receive a TAPP or TEP repair for their     inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).      Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of     an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.      Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year     postoperative, recurrence rate at 12 months, intra-operative and post-operative     complications, post-operative hospital stay, operation time and time to place the mesh, VAS     (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain     at 3 weeks and 12 months, pain medication needed.   "
103102|NCT01936571|"     Lung cancer is the most common cancer type worldwide, with more than 1.1 million annual     deaths. There are two types of the disease, namely non-small cell lung cancer (NSCLC) and     small-cell lung cancer (SCLC), with the first accounting for 85% of the total number of     cases. The 5-year survival across stages remains disappointingly low, around 10% in most     countries, due to a high incidence of both loco-regional and distant failure [3]. However,     during the last decade improved radiotherapy techniques allowed an increase of the radiation     dose, while at the same time more effective chemo radiation schemes are being applied. These     developments have lead to improved outcome in terms of survival. As the TNM staging system is     highly inaccurate for the prediction of survival outcome for non-surgical patients, attempts     have been made to develop a more accurate risk stratification for these patients [1,2]. A     model based on clinical variables yielded an AUC of 0.74, which was encouraging, but also     left room for improvement [2]. An extended model, which included clinical as well as     biomarker variables, reached a higher AUC, but the limited number of patients included in     this study made it impossible to draw definitive conclusions [1].      New prognostic parameters can be retrieved from several sources, which include anatomic,     molecular and functional imaging, genomics, proteomics and clinical analysis of patients. The     unlimited amount of information is expected to lead to more accurate predictions of     individual treatment outcome [4].      The analysis of biomarkers, including proteins, is a fast developing, promising and     challenging area of research. Biomarkers can measure or evaluate normal biological processes,     pathogenic processes, or pharmacological responses to a therapeutic intervention.     Oncoproteins are produced by, or in response to tumor cells, and may be secreted in the     circulation of patients. As tissue sampling is often not possible in lung cancer patients,     blood sample collection by venepuncture offers an attractive alternative, which is safe and     easy to implement. A number of studies described the prognostic and predictive value of blood     biomarkers for NSCLC [5-7]. In this study we will investigate the prognostic value of blood     biomarkers related to 1) hypoxia: Osteopontin (OPN), carbonic anhydrase IX (CA-9), and     lactate dehydrogenase (LDH); 2) inflammation - interleukin 6 (IL-6), IL-8, and C-reactive     protein (CRP), and α-2-macroglobulin (α-2M); and 3) tumor load: Carcinoembryonic antigen     (CEA) and cytokeratin fragment (CYFRA 21-1).        1. Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, et al. Development          and validation of a prognostic model using blood biomarker information for prediction of          survival of non-small-cell lung cancer patients treated with combined chemotherapy and          radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J          Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-368.        2. Dehing-Oberije C, Yu S, De Ruysscher D, Meersschout S, Van Beek K, Lievens Y, et al.          Development and external validation of prognostic model for 2-year survival of          non-small-cell lung cancer patients treated with chemoradiotherapy. Int J Radiat Oncol          Biol Phys. 2009 Jun 1;74(2):355-362.        3. Travis WD, Brambilla E, Müller-Hermelink HK, Harris CC. World Health Organization          Classification of Tumours: Pathology and Genetics of Tumours of the Lung, Pleura, Thymus          and Heart. Paul Kleihues MD, Leslie H. Sobin MD, editors. Lyon, France: IARC Press,          International Agency for Research on Cancer; 2004.        4. Lambin P, Rios-Velazquez E, Leijenaar R, Carvalho S, van Stiphout RG, Granton P, et al.          Radiomics: extracting more information from medical images using advanced feature          analysis. Eur J Cancer. 2012 Mar;48(4):441-446.        5. Donati V, Boldrini L, Dell'Omodarme M, Prati MC, Faviana P, Camacci T, et al.          Osteopontin expression and prognostic significance in non-small cell lung cancer. Clin          Cancer Res. 2005 Sep 15;11(18):6459-6465.        6. Muley T, Fetz TH, Dienemann H, Hoffmann H, Herth FJ, Meister M, et al. Tumor volume and          tumor marker index based on CYFRA 21-1 and CEA are strong prognostic factors in operated          early stage NSCLC. Lung Cancer. 2008 Jun;60(3):408-415.        7. Pine SR, Mechanic LE, Enewold L, Chaturvedi AK, Katki HA, Zheng YL, et al. Increased          levels of circulating interleukin 6, interleukin 8, C-reactive protein, and risk of lung          cancer. J Natl Cancer Inst. 2011 Jul 20;103(14):1112-1122.   "
103103|NCT01936558|"     With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding     normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each     subject using the techniques of fMRI and meridian response.   "
103127|NCT01936233|"     Sustained chronic hepatitis B virus inflammation is a major cause of liver cancer occurrence     and development. Antiviral treatment can block the persistent infection. Aspirin can inhibit     platelet function and CD8 + T cell mediated liver cell necrosis and inflammation. Aspirin     also can inhibit liver cancer cells metastasis through inhibit COX2.   "
104567|NCT01917448|"     One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain.     Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour     postoperative requirement comparing to control group.   "
103104|NCT01936545|"     Postoperative pulmonary complications are not uncommon after liver transplantation. They can     not only prolong the stay in intensive care unit and in hospital but also increase the     morbidity and mortality rate. The underlying mechanisms are multifactorial, however,     oxidative stress following hepatic ischemia reperfusion and the ensuing pulmonary leukocyte     infiltration play an important part in the pulmonary complications. Various drugs and methods     such as ischemic preconditioning have been used to lessen the production of oxidative free     radicals following hepatic ischemia reperfusion. The choice of different anesthetic agents     could aslo change the degree of production of oxygen species and antioxidant capacity during     the operation.      Volatile and intravenous anesthetic agents can decrease oxidative injuries through different     mechanisms, however, which is better in preventing the pulmonary leukocyte infiltration is     still unknown.      We attempt the compare the oxidative stress and cytokine level in liver transplant recipients     under desflurane or propofol anesthesia to evaluate which kind of anesthetic agent is better     in this kind of surgery.   "
103105|NCT01936532|"     This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of     MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed     multiple myeloma. The patient population will consist of adult men and women younger than 66     years, who have a confirmed diagnosis of MM who meet eligibility criteria.      Following the screening period, patients will be enrolled and treated then, they will receive     induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After     Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase     (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance     therapy (start 1 month after the last cycle of consolidation) during 12 months.   "
103106|NCT01936519|"     This study will examine the renal sparing impact of implementing a strategy of conversion to     everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post     liver transplant   "
103107|NCT01936506|"     This study is evaluating the effects of two brain training exercises on: memory, cognitive     processing and depression symptoms.   "
103108|NCT01936493|"     The purpose of this study is to search for the hereditary (genetic) causes of uterine     fibroids. Some women with uterine fibroids may have one or more genes that make them more     likely to develop uterine fibroids. We are trying to identify these genes to better     understand how and why uterine fibroids develop and to design better treatment options for     women with uterine fibroids. This information may also help us to understand and treat other     problems that may be caused by these genes.   "
103109|NCT01936480|"     The purpose of this study is to assess the ability of common genetic variants in aggregate to     predict drug-induced QT prolongation in healthy subjects using moxifloxacin.   "
103110|NCT01936467|"     The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a     standard 22-gauge needle using either standard-suction or capillary suction methods for     solid pancreatic lesions. Investigators hope to discover the best technique for obtaining     diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and     fine needle aspirate procedure.      There are currently several techniques for obtaining tissue during endoscopic ultrasound and     fine needle aspirate. The procedure will be performed by either the capillary suction     technique or no suction technique.   "
103111|NCT01936454|"     A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the     3rd and 4th years of use in Chinese women   "
103112|NCT01936441|"     Self-reported sleep complaints are common in peri- and postmenopausal women and have been     identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of     Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep     Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The     target population will include women in general good health, aged 40-65 years, who report     symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to     enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the     women will be randomly assigned to receive the behavioral intervention and half to receive     the behavioral control.      The intervention arm participants will receive 6 sessions of a telephone-based,     cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art     methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I).     The control arm participants will receive telephone-based Menopause Education Control (MEC)     that includes elements of sleep hygiene. Assessments for both groups will be collected at     baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization.      The inclusion/exclusion criteria are designed to target broadly those midlife women who have     menopause-related sleep disturbance and also report being bothered by vasomotor symptoms.     This target population defines the clinical population seeking treatment for relief of     menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to     exclude women with significant medical problems likely to account for their sleep problems     (instead of menopause), or likely to interfere with their ability to participate in the     intervention. We include women taking hormone therapy or other medication who meet these     criteria because they are part of the population seeking clinical care for relief of sleep     disturbances.      Our primary objective is to develop an intervention that is generalizable to the greatest     number of women and maximally translatable into real-world primary care practice.   "
103113|NCT01936428|"     The purpose of this study is to evaluate (thanks to analysed interview) the perception of     palliative care by relatives of patients treated in oncology.   "
103255|NCT01934556|"     The purpose of this research study is to determine if a Treat and Extend regimen     (increasing the time between visits when the disease is stable and not getting worse) of     Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with     swelling of the retina from diabetes.   "
103114|NCT01936415|"     In a prospective randomised study two uncemented tibial components with different coating     (Vanguard® porous coating, Biomet and Regenerex® Primary Tibial Tray, Trabecular Metal     coating, Biomet) used for total knee arthroplasty (TKA) are evaluated. Both tibial component     coatings are designed to provide excellent conditions for bone ingrowth.      The differences between the two tibial components are evaluated by measurements of migration     of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the     adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry     (DEXA).   "
103115|NCT01936402|"     Unlikely the other element for high quality chest compression during Cardiopulmonary     resuscitation(i.e. compression rate, chest recoil, hand position), chest compression depth     (CCD) is influenced by surface on which the patient is placed, especially in hospital. For     solving this problem, to place the patient on rigid surface, use a backboard that might     decrease the mattress compression, receive a feedback that reflects the mattress compression     depth (MCD) using dual accelerometer or magnetic sensor have been proposed. As the other     solution, we hypothesized that training of 6-7cm CCD for healthcare providers improve     accurate CCD during cardiopulmonary resuscitation when manikin is placed on mattress in     hospital.   "
103116|NCT01936389|"     Glaucoma is the world's the second leading cause of irreversible blindness. The World Health     Organization (WHO) estimated the incidence of blindness due to glaucoma to be 4.4 million     people worldwide in 2002. Intraocular pressure (IOP) is the sole proven modifiable risk     factor for the development and progression of glaucomatous optic neuropathy. Medical therapy     is aimed at lowering IOP in order to prevent or slow progression.      Exfoliation syndrome (XFS) is the most common identifiable cause of open-angle glaucoma,     affecting an estimated 60 to 70 million people worldwide. Approximately two-thirds of     patients have disease in only one eye on clinical examination; however, XFS is detectable in     the other eye with conjunctival biopsy. XFS is also a systemic disease, with effects on the     cardiovascular and cerebrovascular systems.      Patients with XFS are twice as likely to convert from ocular hypertension to glaucoma.     Glaucoma in XFS is more severe than primary open angle glaucoma. There is greater diurnal IOP     fluctuation, greater visual field loss and optic nerve head damage at the time of diagnosis,     poorer response to medications, more rapid visual field progression and more frequent need     for surgery.      Because you meet eligibility criteria for our study, we ask for your consent to participate     in the study described below. In brief, you will be taking an investigational drug (AR-12286,     rho-kinase Inhibitor) at either 0.5% or 0.7% once a day for 6 months. This drug is currently     being tested in patients with primary open-angle glaucoma, but not yet in glaucoma in     exfoliation syndrome. Because of the mechanism of glaucoma in XFS and the mechanism of action     of rho-kinase inhibitors, there is reason to think it would be more effective in eyes with     XFS and glaucoma than in primary open-angle glaucoma (ordinary glaucoma). There will be a     baseline and study day 1 visit, week 1 visit, month 1 and 3 visit, week 13 visit, month 6     visit and a week 25 visit; for a total of 7 office visits.   "
103117|NCT01936376|"     The project is designed to test new biomarkers that are more sensitive than the current     standard in detecting injury to the proximal kidney tubule and will establish better criteria     for when kidney safety concerns may halt further testing of a drug in humans.   "
103118|NCT01936363|"     This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating     the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib     placebo administered once per day compared to pimasertib administered twice per day plus     SAR245409 placebo administered once per day in subjects with previously treated unresectable     low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal     tumors.   "
103119|NCT01936350|"     Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac     magnetic resonance for ventricular analyses and after this first exam they will be randomized     to placebo or Sildenafil. After one hour drug intake they will undergo another cardiac     magnetic resonance to evaluate the drug impact on right and left ventricular function.   "
103120|NCT01936337|"     In this study, the safety, tolerability and efficacy of DLX105 administered topically onto     the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.   "
103121|NCT01936324|"     The purpose of this study is to determine the safety and tolerability of DRM01B topical in     healthy volunteers. Following review of safety data, this study will determine the safety,     tolerability and preliminary efficacy of DRM01B Topical Gel in subjects with acne vulgaris   "
103122|NCT01936311|"     The purpose of this study is to test whether having patients identify a self-management goal     (health goal), prior to a visit with their primary care provider, leads to health behavior     improvement over six weeks.   "
103123|NCT01936298|"     The investigators evaluate the effectiveness of the application of continuous passive motion     device for hand rehabilitation in two classes of patients: with a residual active motion and     without a residual active motion.   "
103124|NCT01936285|"     -  There is evidence that inflammatory processes may play detrimental role during the acute          phase of myocardial infarction        -  The hypothesis of this study is that colchicine, by its anti-inflammatory action, may          lead to reduction in infarct size, when administered during the acute phase of          myocardial infarction   "
103125|NCT01936272|"     Two treatment options exist for infant patients with hydrocephalus. Most patients are treated     with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent     years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV)     with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the     results of these procedures in children less than six months of age who have hydrocephalus as     the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study     will evaluate patients in more detail to measure brain growth and development.   "
103135|NCT01936129|"     This is a randomised controlled trial to assess the neuroprotective effect of Cop-1     (Copaxone) in patients with acute primary angle closure (APAC). The standardized management     of APAC will include medical therapy to reduce intraocular pressure (IOP), followed by laser     peripheral iridotomy. Cop-1 will be administered in addition to standard therapy as a     subcutaneous dose once within 24 hours of presentation, and then one week later (total 2     injections). The control group will have placebo in addition to standard regimen. Subjects in     the study will have visual field test performed with the Humphrey Visual Field Analyzer II,     retinal nerve fibre layer (RNFL) thickness measured with the Stratus optical coherence     tomography (OCT) and Optic nerve head evaluated with the Heidelberg retinal tomography (HRT).     At least 2 baseline visual field tests will also be performed in the first week. Subsequent     visits will be at week 4, 8, 12 and 16. The outcome criteria will be difference in visual     field, RNFL thickness, and optic nerve head structural changes.   "
132485|NCT01550848|"     The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with     Gemcitabine in the patients with metastatic breast cancer.   "
103126|NCT01936246|"     To date, few studies have been done regarding nutrition supplementation in infants with brain     injury. Therefore, the investigators are proposing to study the effects of protein     supplementation in this group of babies. The investigators will recruit 24 infants with brain     injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the     Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon     diagnosis, the investigators will obtain consent from the parents for participation in the     study, then randomly assign the baby to one of two groups - an increased protein group and a     control group. Both groups of infants will be monitored to ensure no adverse effects occur     due to the supplementation.      Protein supplementation will continue for the first 12 months of age. Growth parameters, such     as weight, length, and head circumference, will be measured while the infant is the NICU.     Head circumference will be measured in the investigators outpatient clinic at three, six, and     12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes     using the Bayley Scales of Infant Development. The investigators hypothesize that infants who     receive the additional protein will demonstrate increased head growth and improved     neurodevelopmental outcomes.   "
103128|NCT01936220|"     Objective: to evaluate the effectiveness of specialised and sustained intervention with or     without parent groups during the initial phase of schizophrenia or related disorders on     relapse prevention      Methods: A three conditions randomized trial with a duration of five years      Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic     episode of schizophrenia or related disorder      Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent     groups (ST+P) and Treatment As Usual (TAU).      Outcome-measures: cumulative relapse rates and time to first relapse after first remission.     Secondary outcome measure: social functioning.      Statistical analysis: cumulative relapse rates using life-table methods. The effect of the     three interventions on time to first relapse after remission will be compared using Cox     regression analysing intention to treat (ITT) grouping.   "
103129|NCT01936207|"     IC-GLOSSARI (The Intensive Care GLObal Study on Severe Acute Respiratory Infection) is a     multicentre, prospective, observational,14-day inception cohort study designed and conducted     by the ESICM Trials Group to investigate the epidemiology and microbiology profiles of     ICU-SARI, document commonly used treatment and monitoring strategies, measure current     outcomes and identify potential topics for multidisciplinary studies ranging from     interventional clinical trials to fundamental mechanisms of disease.      The purpose of this study is to answer the following questions:      What is the frequency and disease burden of SARI for ICU's worldwide? What are the     aetiologies of ICU SARI? How are SARI patients diagnosed and managed in the ICU? What is the     outcome from SARI in the ICU? Is there a difference in outcomes from SARI depending on the     aetiology of the disease? Can we identify high-risk categories of SARI that could constitute     a defined population for an interventional study?   "
103130|NCT01936194|"     This clinical trial will study the effects of PUFA supplementation during pregnancy and     lactation period on fatty acid composition in human milk and plasma of the mothers and the     clinical outcome of atopic dermatitis in infants at increased risk.   "
103131|NCT01936181|"     This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate     the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in     subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)     therapy.   "
103132|NCT01936168|"     The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that     combines mechanical endothelial damage using a rotating wire with the infusion of a liquid     sclerosant. Heating of the vein and tumescent anesthesia are not required; only local     anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA,     using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV)     incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of     this technique in terms of obliteration rates are lacking. This randomized trial was designed     to compare occlusion rate, post-operative pain and complications between radiofrequency     ablation (RFA: the current treatment for GSV incompetence) en MOCA.   "
103133|NCT01936155|"     Neuromuscular Electrical Stimulation (NMES) will be facilitated through the use of a     stimulator, with the patient in a semi recumbent position, using UltraStim electrodes. Two 5     cm x 5 cm electrodes will be placed over the soleus muscle for calf stimulation. The     participant will be allowed to ramp up the stimulus level themselves to get used to the     sensation and determine their maximum tolerated stimulus level.      A goniometer will be used to assess mobility at the knee and ankle joints. Transcutaneous     oxygen measurements (tcpO2) will be assessed using the PERIMED Periflux System 500 tcpO2     monitor.      The level of oedema will be measured using the figure of eight measurement, tape     circumference measurement and water displacement measurement.      Comfort will also be assessed by use of a 100mm non-hatched visual analogue scale (VAS). Each     participant will be asked to indicate their level of comfort following the application of     NMES.   "
103134|NCT01936142|"     The purpose of this study is to determine whether the use of RenalGuard system which creates     high urine output with fluid balancing may prevent contrast induced nephropathy in patient     undergoing cardiac resynchronization therapy (CRT) implantation.   "
103136|NCT01936116|"     Saline infusion sonohysterography and other intrauterine investigations methods may cause     uterine cramping, pain and vasovagal reactions. According to few of previous studies the     position of catheter placement can affect the magnitude of pain and amount of saline required     during the sonohysterography. The purpose of this double blind control trial study is to     assess whether the location of the balloon catheter either the uterus or cervix during     sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.   "
103137|NCT01936103|"     First acute anterior myocardial infarction in patients with primary PCI preoperative and     postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional     -dose therapy , patients can improve left ventricular function , reduce major adverse     cardiovascular events .   "
103138|NCT01936090|"     This phase I/II trial studies the side effects and best dose of bortezomib when given     together with melphalan, and total-body irradiation before stem cell transplant and to see     how well it works in treating patients with multiple myeloma. Giving chemotherapy and     total-body irradiation before a stem cell transplant stops the growth of cancer cells by     stopping them from dividing or killing them. The stem cells that were collected from the     patient's blood or bone marrow are returned to the patient to replace the blood-forming cells     that were destroyed by the chemotherapy and total-body irradiation.   "
103149|NCT01935947|"     This randomized phase II trial studies how well azacitidine and entinostat before     chemotherapy works in treating patients with non-small cell lung cancer that has spread to     other places in the body. Drugs used in chemotherapy, such as azacitidine, irinotecan     hydrochloride, gemcitabine hydrochloride, docetaxel, and pemetrexed disodium, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Entinostat may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and     entinostat before chemotherapy may work better in treating patients with non-small cell lung     cancer.   "
103150|NCT01935934|"     This phase II trial studies how well cabozantinib-s-malate works in treating patients with     endometrial cancer that has come back (recurrent) or has spread to other places in the body     (metastatic). Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the tumor.   "
103139|NCT01936077|"     The ideal stimulation protocol for ovarian stimulation is under constant debate, as we gain     more pharmacological control over the patient hormonal milieu. Specifically, the debate     focuses around the ideal LH levels. The concept of an LH window was suggested.      The need for a threshold level of LH is clearly demonstrated in hypogonado-tropic     hypogonadism patients, but also in cycling patients receiving high doses of GnRH antagonist.     The Ganirelix dose finding study demonstrated very low implantation rates in the high dose     groups (1 mg, 2 mg).      The stimulation dynamics in these patients were remarkable for very low E2 and LH levels on     the day of hCG. In fact, a functional state of hypogonadotropic hypogonadism is achieved,     explaining the poor clinical results (1.5% implantation rate under 2 mg Ganirelix). The same     protocol was repeated with added Luveris resulting in excellent pregnancy rates.      The recommended daily dose of GnRH antagonist is 0.25 mg which on the average provides a     protection from premature LH surge, with moderate suppression of LH. Therefore, most patients     do not need supplemented LH after the antagonist is initiated.      However, there is a subgroup of patients who hyper-respond to the antagonist (in 0.25 mg     dose) with a sharp decrease in LH. This explains contradictory findings in the available     studies. The basic assumption in the background of this proposal is that there is a wide     range of pituitary responses to GnRH antagonist. Obeying a bell-shape curve, most women have     an average response, however, some hypo-respond might ovulate prematurely, and others     hyper-respond. In the latter cases, pituitary response will behave as if exposed to a higher     dose.      How to identify an exposure to a presumed higher dose?      Below is a figure from the original paper. A close look indicates that the immediate response     to all Ganirelix doses are similar in terms of LH drop, however, the big difference lies in     the pituitary recovery 24 hours post Ganirelix dose.      While small doses allow for a quick recovery to almost pre-treatment LH levels, high doses     result in incomplete recovery. Hence, it is reasonable to speculate that the high response to     0.25 mg dose will lead to slow or incomplete recovery of LH levels 24 hours post the initial     dose.      It is estimated that about 15% of patients are antagonist hyper-responders. Efforts to     individualize patient protocol must target this group as candidates for supplemented LH. This     estimate is similar to study findings: Huirne et al Human Reproduction 2005, 20: 359.   "
103140|NCT01936064|"     To determine the effective functionality/potency of Jobelyn as an immunologic and     haematologic booster in Breast cancer patients (start-off), thus improving the outlook and     the quality of life of such patients generally   "
103141|NCT01936051|"     To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma     concentration and the transporter occupancy from OCD patients treated with escitalopram.      To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the     PK-PD modeling in OCD patients treated with escitalopram.   "
103142|NCT01936038|"     The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which happens     at night and consists of the interruption of airflow for more than five seconds. His current     treatment by continuous positive pressure nocturnal machine (CPAP) is not curative and     therefore the level of compliance is key to patient improvement. Many patients don´t tolerate     CPAP by the numerous side effects involved. The Upper Airway Toning is a compendium of     non-invasive techniques that aim to assist tolerance and compliance with the CPAP. These     techniques are: oropharyngeal exercises executed actively by the patient for the muscle     toning of the upper airways, electrostimulation of the muscles in the floor of the mouth,     correction of the tongue position, nasal and bronchial fogging, execution of respiratory     gymnastics, therapy myofascial in the oropharyngeal muscles, manual therapy in the cervical     column,and massage in the diaphragm. All the techniques together seek for a greater or lesser     impact on the upper airways hypotony, the hypotony of the tongue and the soft palate, the jaw     retrognathism, the mouth breathing, the vertebrobasilar syndrome, the gastroesophageal     reflux, the excessive accumulation of secretions in the upper and lower airways, the     obstructive and restrictive respiratory problems, the sleeping posture, the hypertonia of the     diaphragm due to the excess effort in trying to overcome the respiratory obstruction. All     these disfunctions will make easier for the patient to show side effects in the use of CPAP.     There will be a double-blind randomized controlled study with 110 individuals. One group will     follow the conventional medical treatment with CPAP and the other group medical treatment     plus Upper Airway Toning. After six months, the mean improvement between the two groups will     be compared.   "
103143|NCT01936025|"     The study has a randomized, double-blind, placebo-controlled, double dummy and eight-way     cross-over design. Males with T2DM on a stable metformin monotherapy will be screened for     participation in the study. Eligible subjects will be randomized to receive DXM 30 mg, DXM 60     mg, DXM 90 mg alone or in combination with sitagliptin 100 mg, sitagliptin 100 mg alone, or     placebo (for DXM and sitagliptin) on in total eight treatment days. An OGTT will be started 1     hour after study drug administration and blood glucose will be measured over the next 4     hours. There will be a 3 to 14-day washout period between doses.   "
103144|NCT01936012|"     The present study was conducted to find out whether the bioavailability of 10 mg lisinopril     tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator     (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra     Zeneca UK Ltd.)   "
103145|NCT01935999|"     A study to assess the safety and performance of an enhanced one piece closed pouch in a 12     subjects with a colostomy.   "
103146|NCT01935986|"     The purpose of this study is to study the effect of a probiotic on protection against upper     respiratory tract infections (URTI) in children.   "
103147|NCT01935973|"     This randomized phase II trial studies how well trametinib with or without GSK 2141795     (protein kinase B [Akt] inhibitor GSK2141795) works in treating patients with endometrial     cancer that has come back (recurrent) or does not go to remission despite treatment     (persistent). Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib     is a more effective treatment for endometrial cancer when given with or without ATK inhibitor     GSK2141795.   "
103148|NCT01935960|"     This randomized phase I trial studies the side effects and best dose of retinoid 9cUAB30 in     preventing cancer in healthy volunteers. The use of retinoid 9cUAB30 may keep cancer from     forming in healthy volunteers.   "
103174|NCT01935622|"     Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of     systemic inflammation.      Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful     anti-inflammatory effects.      In this study we plan to determine the effects of Doxycycline in patients with stable heart     failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and     ventilator efficiency measured with a cardiopulmonary test.   "
103176|NCT01935596|"     This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric,     phase IV comparison of the effects of two local anesthetics intrathecally: 0.5%     levobupivacaine and ropivacaine 0.5%.   "
103499|NCT01931384|"     A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer     cycles.      The hypothesis of the study is that the use of luteal phase support with human chorionic     gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.   "
103151|NCT01935921|"     This phase Ib trial studies the side effects and best dose of ipilimumab when given together     with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with     previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as     ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain     cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.     Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.   "
103152|NCT01935908|"     The purpose of this study is to determine the feasibility of prospectively enrolling and     randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam     or not to receive levetiracetam, and documenting in-hospital and follow-up clinical     variables.   "
103153|NCT01935895|"     Introduction: Daily stress levels of population are increasing over the last decades.     Frequent spouse to stress is considered an important risk factor for development of     cardiovascular diseases. Other well documented risk factor for cardiovascular diseases is     systemic hypertension which, in turn, has been related to elevated blood pressure reactivity     (BPR) to stress. The exacerbated BPR may suggest a poor autonomic modulation due to an     elevated sympathetic tone, condition that has been associated with medium to long-term     cardiovascular complications. Also, some reports have demonstrated that individuals     hyper-reactive to stress chronically increase their risk for psychological disorders such as     anxiety, irritability and frustration. These feelings are associated to increased sympathetic     tone induced chronic elevation in BP. Although the hemodynamic benefits of aerobic and     resistance exercises had been documented in a variety of reports5, the acute effects of the     aforementioned exercise modes combined in a circuit method on post-exercise BP, including the     responses to cardiovascular stressor test need further investigations. Objective: To     investigate the blood pressure (BP) responses to cardiovascular stressor test after a     combined exercise circuit session at moderate intensity. Methods: Twenty individuals     (10male/10fem; 33.4±6.9years; 70.2±15.8kg; 170.4±11.5cm; 22.3±6.8 %body fat) volunteered to     randomly perform on different days: 1) Exercise session consisting of 3-laps in a circuit     model in the following sequence: knee extension, bench press, knee flexion, rowing in the     prone, squat, shoulder press and 5-min of aerobic exercise at 75-85% of age-predicted maximum     heart rate and/or 13 in the Borg-Scale [6-20]. The sets of resistance exercise were composed     by 15 repetitions with ~50% of one repetition maximum test and; 2) a control session without     exercise. The systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured     at resting and during 1h of recovery in both experimental sessions. After that, blood     pressure reactivity (BPR) was evaluated using the Cold Pressor Test (a test with hand in the     cold water during one minute). The hypotheses are that after doing the exercise session occur     attenuation of blood pressure increase during the Cold Pressor Test compared to sitting     without exercise (control session).   "
103154|NCT01935882|"     Primaquine (PQ) is currently the only available drug that can clear mature transmission     stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist     after artemisinin-combination therapy. However, there are safety concerns about the use of PQ     at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate     dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD     deficient individuals; this side-effect is dose dependent. There are indications that a lower     dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious dose for     gametocyte clearance is currently unknown. Recently, the World Health Organization changed     their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no direct     evidence on the extent to which (low dose) PQ prevents malaria transmission to mosquitoes and     what the lowest efficacious dose is.      In the current study we aim to identify the lowest efficacious dose of PQ in individuals with     normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme function will     be randomized to treatment with artemether-lumefantrine alone or in combination with low     doses of PQ. All enrolled individuals will receive a full three-day course of AL, and will be     randomized to receive a dose of primaquine or placebo with their fifth dose of AL. Efficacy     will be determined based on gametocyte carriage during follow-up, measured by molecular     methods. For a subset of participants with patent gametocytes, primaquine effect on     infectivity to mosquitoes will be assessed by membrane feeding assays   "
103155|NCT01935869|"     The purpose of this study is to determine the skin irritation potential and sensitisation     potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy     subjects.   "
103156|NCT01935856|"     This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single     and multiple administration of KHK7580 for secondary hyperparathyroidism in patients     receiving hemodialysis   "
103157|NCT01935843|"     RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous T cells may make the body build immune response to kill cancer cells.      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in     treating patients with HER-2 positive advanced solid tumors,such as breast cancer, gastric     cancer, hepatic carcinoma, endometrial cancer and ovary cancer.   "
103158|NCT01935830|"     The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz     and ritonavir on human brain LAAM disposition in vivo.   "
103159|NCT01935817|"     Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting     mainly from the complications of cirrhosis and HCC.      The investigators' aim will be to evaluate the impact on of supplementation with a new     pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis     C treated with Pegylated-Interferon-α2b plus Ribavirin.   "
103160|NCT01935804|"     The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health     including bone mineral density, bone turnover markers, and osteocyte biomarker in patients     with type 2 diabetes (T2DM).   "
103161|NCT01935791|"     The purpose of this study is to determine what can activate brown adipose tissue (BAT).   "
103162|NCT01935778|"     The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC     (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are     currently accepted as a standard therapy among the AGC patients who were performed     gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and     IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as     one of the best treatments for IIB and IV(M0) stage AGC patients who were performed     gastrectomy.   "
103177|NCT01935583|"     1. To evaluate the short and longer-term efficacy of a structured outpatient intervention          program (The Resilience and Adjustment Intervention, RAI) to improve survivors'          resilience.        2. To evaluate the impact of treatment on emotional well-being and postinjury adjustment.        3. To evaluate the impact of the intervention on abilities including problem solving,          communication, and stress management.        4. To examine the extent to which treatment benefits are sustained in the longer-term.   "
103163|NCT01935765|"     Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due     to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in     some studies diabetes status. Few data are available for type 1 diabetes but suggest that the     prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep     apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a     control group matched by age, gender and body mass index. The secondary objective is to     determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed     by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the     diabetic group.   "
103164|NCT01935752|"     Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial     disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown     origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of     narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery,     arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several     factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order     to progress into identifying possible causative mechanisms of the disease, we design a     pathophysiology study destined to assess endothelial function in patients with fibromuscular     dysplasia and to identify possible plasmatic biomarkers of the disease.   "
103165|NCT01935739|"     The purpose of this study is to determine discordant HER2/neu status of primary breast tumor     and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer     patients.   "
103166|NCT01935726|"     As the name states, contact registries securely store contact information from groups of     reasonably well-characterized patients (or primary supporters/caregivers) who are interested     in being informed about ongoing or future research opportunities. Pulmonary fibrosis (PF) is     a condition for which effective therapies have remained elusive, making drug trials and     interventional research studies a mainstay in the PF arena over the last decade and for the     foreseeable future. A PF Contact Registry will be a conduit to collect, analyze, and     disseminate de-identified, group-level data on the clinical phenotypes of PF patients and     will house contact information from patients who wish to be informed about research     opportunities for which they may qualify. Data contained in the Registry will help inform     research hypotheses and guide investigators as they develop research protocols by providing     them with numbers of potential subjects who meet particular inclusion/exclusion criteria.   "
103167|NCT01935713|"     The overall aim of the current study is to determine if the use of nicotine containing     products by caregivers who smoke and who are not interested in quitting, is effective in     reducing children's secondhand smoke exposure.   "
103168|NCT01935700|"     This trial is to evaluate the potential of colchicine for the palliative management of     hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the     Department of Health R.O.C. approved doses and methods of administration.   "
103169|NCT01935687|"     The purpose of this study is to validate an instrumented wheel such as a new biomedical     device. The physicians will compare this instrumented wheel with another instrumentation     Ergometer roller, each patient will try the both instrumentations, physical and     physiological parameters will be measured.      The increase rate of radial power during the cardiac stress test may be more important when     the physicians use the instrumented wheel.   "
103170|NCT01935674|"     To compare the effect of rosuvastatin to protease inhibitor switching on fasting total     cholesterol over 12 weeks.   "
103171|NCT01935661|"     β-thalassemia syndromes are a group of hereditary disorders characterized by a genetic     deficiency in the synthesis of beta-globin chains.      In recent studies done in β-thalassemia major patients abnormal iron deposition was evident     using MRI in brain structures, cortex, putamen, and caudate nucleus . In most of the cases     the neurological involvement is subclinical. Cognitive functioning was evaluated in beta     thalassemia major, compared with healthy controls, using a neuropsychological battery     including tests of abstract reasoning, attention, executive functions, language,     constructional/visuospatial skills, and memory. Patients with beta thalassemia major, in     particular those showing signs of hemosiderosis, had significantly impaired function in all     neuropsychological tests. There was no relationship between cognitive performances and signs     of deferoxamine toxicity, deferoxamine dosage, and levels of hemoglobin and ferritin.     Event-related potentials (ERPs) are one of the most informative and dynamic methods of     monitoring the information stream in the living brain. ERPs are linked in time with a     physical or mental event, and are typically extracted from the scalp-recorded     electroencephalogram (EEG) by means of signal averaging.      ERPs have been used in the assessment of cognitive function in several disorders, including     anemia and iron deficiency anemia. However, literature regarding cognitive function and ERP     activity in thalassemia patients is extremely limited, especially in adults.      The purpose of this study is to evaluate the cognitive and brain function in a group of 60     thalassemia patients and compare the results to healthy controls.   "
103172|NCT01935648|"     The primary goal is to evaluate ropivacaine blood concentrations during and after local     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee     replacement surgery. The investigators plan to measure these levels by testing blood samples     taken over a timed period.      This will allow us to confirm whether the current regimen of local anaesthetic use is within     safe limits.   "
103173|NCT01935635|"     The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With     Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic     hepatitis B patients   "
103190|NCT01935414|"     This study hypothesises that the geko™ device is more efficient than TEDS in preventing the     formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.   "
103175|NCT01935609|"     1. To evaluate the efficacy of a structured outpatient couples intervention program          (Therapeutic Couples Intervention, TCI) on couples' marital quality after acquired brain          injury (ABI).        2. To assess the impact of the TCI on the emotional well-being of persons with ABI and          their partners.        3. To ascertain the impact of the TCI on caregiver burden and unmet needs as reported by          partners of persons with ABI.        4. To examine the extent to which treatment benefits for survivors and their caregiving          partners are sustained in the longer-term.   "
103178|NCT01935570|"     This clinical study is composed of two steps. The first step aims at validating the     pharmacokinetic approach based on the magnesium concentration in erythrocyte and plasma.      According to these results and if this pharmacokinetic approach is validated, the second step     will set up. The second phase aims at comparing the relative bioavailability of magnesium     administrated by two different drug formulations: ChronoMag Smart Tablet® (two tablets50mg)     versus Mag2® (three tablets100mg).   "
103179|NCT01935557|"     Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing     during the procedure is important.      Randomized comparison of continuous and intermittent heparin infusion during catheter     ablation of Atrial Fibrillation.   "
103180|NCT01935544|"     Botulinum toxin injections are an effective treatment of limb spasticity after stroke.     Different tracking techniques are used to locate a proper injection spot. Palpatory technique     is barely effective and induces a high risk of error. Localization by electro stimulation is     frequently used in adults, but often requires multiple painful repositioning of the needle.     Ultrasound tracking is sometimes used in children but not much in adults.      The advantages of ultrasound-guided botulinum toxin injections are a painless localization     and greater injection accuracy. Safety is therefore enhanced since intravascular injection is     easily avoided.      The few existing publications on the subject are essentially case reports. Few studies have     focused on comparing different injection techniques and so far, no well-conducted study has     highlighted superior efficiency of ultrasound-guided injections.   "
103181|NCT01935531|"     The rationale of this study is to investigate the effects of topical diclofenac on tumor     metabolism in the treatment of actinic keratoses in immunocompetent and immunocompromised     patients.      Study hypothesis is that topical diclofenac lowers lactate level in skin biopsies of actinic     keratoses. Planned number of patients is 38.      This study is a monocenter study investigating the effects of 3% diclofenac in 2.5%     hyaluronic acid gel on tumor metabolism in the treatment of actinic keratoses. Treatment     duration is 3 months. Skin biopsies will be obtained before treatment, at the end of the     treatment and four weeks after the treatment. Control biopsies at visit 1 and 3 are performed     in healthy, sun damaged and untreated skin. Evaluation of efficacy will be performed at the     end of the treatment and four weeks after the treatment.      Duration of treatment is 3 months (±4 weeks). Approximately 0,5g Solaraze® 3% gel is applied     on a 5cm x 5cm lesion. Solaraze® 3% gel is applied twice daily on the study lesions.   "
103182|NCT01935518|"     This study will examine whether fasudil is effective and safe in treating patients with     amyotrophic lateral sclerosis (ALS).   "
103183|NCT01935505|"     This is a observation non-randomized control trial, and a follow-up study on the smoking     cessation.   "
103184|NCT01935492|"     An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8     cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in     combination with bevacizumab, and second line treatment of patients with HER2/neu negative,     incurable, metastatic or unresectable locally advanced breast cancer.   "
103185|NCT01935479|"     The objective of this study is to investigate the pharmacokinetics, safety, and tolerability     of AK159 administered to healthy postmenopausal women.   "
103186|NCT01935466|"     Pioglitazone, an agonist of the peroxisome-proliferator-activated receptor (PPAR), is a     relatively new oral anti-hyperglycemic drug. Since its first approval in the USA in 1999, a     potential link with bladder cancer has been a subject of debate. US Food and Drug     Administration (FDA) in September, 2010 and European Medicines Agency in July, 2011 issued an     alert about a potential relation between the occurrence of bladder cancer and the     prescription of pioglitazone, based on the data from various studies. France banned its use     in July 2011.      Recently Pioglitazone was banned from India without any evidence of increased bladder cancer     in our population. With this background, we plan to study the risk of bladder cancer in male     type 2 diabetes subjects aged more than 50 years who are on pioglitazone therapy as compared     to never-users of pioglitazone in a retrospective cohort design and provide the first data     from India to the policy makers regarding the purported risk in our ethnicity and     geographical area.   "
103187|NCT01935453|"     The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds     of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.   "
103188|NCT01935440|"     The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive     drug users to be peer health educators.   "
103189|NCT01935427|"     This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI     system.      Healthy human subjects will undergo progressive reduction in central blood volume to the     point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure     (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as sweating,     nausea, or dizziness) to validate the following hypotheses:      The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend     stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading,     instead it is an actual CRI trend value that does not require calibration or being placed     during normal physiological conditions.   "
103191|NCT01935401|"     The purpose of this study will be to replicate previous findings of deficits in prefrontal     activation during response inhibition tasks in bulimia nervosa and extend these findings by     demonstrating similar deficiencies in activity during a functional behavioral task that     requires the inhibition of eating. Findings from this study will potentially help to     elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and     prevention efforts.   "
103226|NCT01934933|"     This is a prospective, open-label trial to evaluate efficacy for delaying ossification and     improving inflammation of celebrex treatment on active ankylosing spondylitis (AS). Subjects     will be randomly divided into three groups (Enbrel group, Celebrex group and Enbrel plus     Celebrex group) and receive responsable treatment for 54 weeks. Clinical response assessment,     laboratory assessment and radiology assessment will be recorded. Primary endpoints are the     magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC)     score and the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) of spine and     sacroiliac(SI) joint, as well as the Assessment of SpondyloArthritis International Society     (ASAS)20 response rate. Secondary Endpoints include ASAS20, ASAS40, ASAS70 and ASAS5/6     response rate on each visit and other clinical indexes.   "
103192|NCT01935388|"     Many hospitals employ a common canister inhaler protocol in patients that do not require     mechanical ventilator support. Common canister refers to a single inhaler paired with     standardized cleaning methods for use on more than one patient. Small reports suggest that     this method does not pose an increased infectious risk and is associated with significant     cost savings.      Common canister protocols offer a solution to the discordance between inhaler sizes and     average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug     for several days to weeks of daily use. However, the average length of stay for most     inpatients is only several days. Therefore, most inpatients do not use all of the canister     contents, an unused resource that is potentially wasted.      The common canister approach has not been previously described in mechanically ventilated     patients (people requiring intensive care unit admission on breathing machines). This study     aims to assess the safety of common canister utilization by assessment and comparison of     infection rates in the study and control group.   "
103193|NCT01935375|"     HYPOTHESES:      The hypotheses are that:        1. nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone          to women with postpartum depression        2. women receiving interpersonal psychotherapy will have less symptoms of postpartum          depression, better functioning, better bonding with their babies, and better          relationships with their partners        3. women with postpartum depression will be more satisfied with their care than women in          the group that was referred to a mental health center.   "
103194|NCT01935362|"     Cardiovascular disease (CVD) is the leading cause of deaths in the Western world. Established     risk factors include high LDL cholesterol, high blood pressure and diabetes. Poor blood     vessel health is considered a predictor of future CVD risk, but can be reversed. Several     different measurements can be used to determine blood vessel health; such as blood pressure     (BP), and newer techniques which measure blood flow through the arteries after a blood     pressure cuff restricts blood flow for a few minutes in one arm.      Flavonoids are compounds found in plant-based foods, and are associated with a reduced risk     of CVD. From the previous studies, there is strong evidence that orange juice and citrus     foods which have higher amount of specific citrus flavonoids improved cardiovascular risk     factors such as BP and blood vessel health. Absorption of citrus flavonoids occurs in the     colon after bacteria breakdown the forms found in food. After the flavonoids are absorbed     into the blood they are modification by liver enzymes before they are excreted in the urine.     A large range of citrus flavonoid have been found excreted in the urinary, ranging anywhere     from 0-57% of the dose. Variation in the potential health effect may reflect the level of the     citrus flavonoid absorbed, and this is not often considered in human studies.      This study is a 4-week double-blinded, randomized, cross-over intervention trial using a     commercially-available orange juice supplement and a placebo control. The aims of the study     are to determine whether orange juice supplements reduce blood pressure and improve blood     vessel health after 4 weeks. Furthermore, to determine if there is a relationship between     absorption of flavonoids (as measured by urinary excretion) and changes in blood pressure or     blood vessel health.      The participants will need to attend 4 sessions on 4 separate study days, every 4 weeks for     12 weeks. On each study day they will have their weight, height, waist circumference, and     blood pressure measured. A finger-prick blood sample, using a single-use lancet (Accu-Chek     Safe T Pro Plus), will be taken to check the fasting blood glucose level. Blood flow in     fingertips will be monitored before and after reducing blood flow in your forearm using a     blood pressure cuff (called an EndoPAT). Participants will be asked to collect urine for 24     hr on each of the study days, and to consume the supplements provided daily for two sets of 4     weeks (there will be 4 weeks in the middle without any supplements).      An improvement in blood pressure and/or blood flow will provide evidence that blood vessel     health has improved through short-term (4 week) use of a citrus flavonoid supplement   "
103195|NCT01935349|"     Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top     10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority     (HA) has initiated service improvement through introducing the patient empowerment programme     (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC     is an essential part of the programme in order to inform future policy. The Family Medicine     Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the     evaluation of the QOC of the programme.      The Action Learning and Audit Spiral methodologies to measure whether the target standard of     care intended by the PEP programme is achieved. Each PEP participating clinic and     non-government organization (NGO) will be invited to complete a structured evaluation     questionnaire. The data of all patients who have enrolled into the PEP for more than one year     will be included in the evaluation on the process and outcomes of care. A hundred and thirty     participants will be followed up by telephone to evaluate the effect of the programme in     quality of life (QOL), patient enablement, and global rating of change in health condition at     baseline and 6 months after enrolment. Data on the process of care will be retrieved from the     HA medical records. Main Outcome Measures: The primary outcomes are the proportion of     participants who have received the planned process of care and achieved the target HbA1c and     blood pressure levels.      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be     calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12     months will assessed by paired sample t-test. The audit cycle will be repeated annually over     a period of 5 years.      Results: The QOC of the PEP programme will be determined. Areas of deficiency and possible     areas for quality enhancement will be identified. Conclusion: The results of this study will     provide empirical evidence on whether the HA's PEP programme can enhance QOC for patients     with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide     service planning and policy decision making.   "
103196|NCT01935336|"     This phase II trial studies how well ponatinib hydrochloride works in treating patients with     stage III-IV lung cancer. Ponatinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
103197|NCT01935323|"     6-week, single site, two parallel arm, randomized, controlled trial comparing the     effectiveness of a High Intensity Interval Training (HIIT) versus a continuous Moderate     Intensity Training (MIT) program on cardiovascular and metabolic health outcomes in     overweight adolescent males. HIIT training may be a potent time-efficient strategy to induce     similar metabolic and cardiovascular adaptations typically associated with MIT.   "
103198|NCT01935310|"     Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre     malignant and malignant lesions caused by UV radiation it reverses histopathological changes     associated with the photoaging skin.      This is an experimental exploratory study. It included 17 patients. The patients were     diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to     participate in the study. Patients were treated with imiquimod 5% topically, for a time     period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4     weeks after completing the treatment. Adverse effects, adherence to therapy and patients'     satisfaction were measured.      Clinical and histological parameters of photoaging were studied at baseline and after     treatment. After completion of treatment with imiquimod, the final clinical evaluation was     compared to the initial one.   "
103199|NCT01935297|"     This pilot study will evaluate the effect of a rehabilitative exercise training on exercise     capacity in patients after percutaneous aortic valve replacement. It will additionally     evaluate the safety of such an approach and the effect on life quality. We hypothesize that     regular structured exercise improves exercise capacity in these patients beyond the sole     effect of the valve procedure.   "
103227|NCT01934920|"     This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME)     in diabetic patients that undergo a DME screening exam. The screening exam will consist of     medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus     photography   "
103228|NCT01934907|"     The hypothesis is that transfusion of washed red blood cell can decrease the complication by     transfusion.   "
103201|NCT01935271|"     The ability of older adults to improve their muscle strength through exercise training     appears related to how well their immune system functions. Thus, a nutritional supplement     which improves immune function could theoretically boost strength gained for older adults     from exercise. The purpose of this pilot study is to determine if a nutritional supplement     has any effect on immune function.      Veterans (age 60-80 yrs, N=12) be randomized in a double-blind placebo-controlled fashion to     consume supplement or placebo for four weeks. After two weeks of consumption, subjects will     be treated with a vaccine for tetanus, diphtheria, and pertussis. Blood will be drawn from     each subject before and after vaccination to determine the effects of the supplement on     immune response to vaccination. Additionally, subjects will undergo blood draw and muscle     biopsy before and after two weeks of supplementation to determine the effects of     supplementation on other measures of immune function (e.g. cytokine and growth factor     levels). This is an important issue due to the serious health consequences associated with     muscle loss in older adults and the need for improved strategies for rehabilitation.   "
103202|NCT01935258|"     Medically unexplained symptoms (MUS) are a common and important problem in primary care.     Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their     symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful     tests, referrals and treatment. Evidence indicate that specific interventions for patients     with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited     help. According to experts in this field a multi-component approach is most helpful for these     patients.      This pilot trial aims to test the systematic identification of eligible patients, to assess     the acceptability of the intervention and to estimate potential treatment effects for a     larger trial.      It's a randomised pilot study consisting of patients with MUS in primary care. Patients will     be randomized to intervention (usual care and additional psychosomatic therapy) or control     condition (usual care alone). Patients will be followed for one year.      Participants are patients consulting their GP more than once with MUS and in which the GP     presumes that psychosocial distress is an underlying cause.      The intervention is the psychosomatic therapy delivered by a psychosomatic therapist,     consists of a combination of information and education, relaxation therapy and mindfulness,     cognitive approaches and activating therapy. This multi-component approach is captured into a     protocol in which therapists are able to modify the treatment in order to deliver a     tailor-made treatment for patients with MUS.      Primary outcome measures are: the number of patients identified and recruited, perceived     symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated symptoms     of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional Symptom     Questionnaire). Other primary outcome measures are the time needed to include the eligible     patients, the number of withdrawals in the intervention and control group, compliance in the     therapy group and the number of patients who complete the questionnaires.      Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation     List), physical and mental health status and quality of life (SF-36), and level of     functioning (MAF: measure of general functioning). Patient satisfaction with the received     therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the     Cost Diary for medical consumption.   "
103203|NCT01935245|"     Rationale:      Cardiac surgery with extracorporeal circulation (ECC) triggers platelets. Minimal     extracorporeal circulation system (minimal-ECC) has several advantages compared with     conventional ECC amongst less platelet activation. Platelet function can be analysed with     thromboelastography (TEG) and multiple electrode aggregometry (MEA).      Objective:      The use of minimal ECC leads to less platelet dysfunction compared with conventional ECC in     coronary artery bypass grafting (CABG) analysed with TEG and MEA      Study design:      Single center, prospective, randomized, pilot study      Study population:      Group 1:      20 patients undergoing CABG using minimal ECC. Patients continued the use of acetylsalicylic     acid and discontinued the use of clopidogrel minimal 5 days preoperative.      Group 2:      20 patients undergoing CABG using conventional ECC. Patients continued the use of     acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative.      Intervention:      Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC      Main study parameters/endpoints:        1. Results of TEG and MEA, see detailed description        2. Per operative blood loss and total blood loss 24 hours after CABG        3. Total amount of transfused platelet units during CABG and 24 hours after CABG   "
103204|NCT01935232|"     Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture     risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are     diagnosed only after a fracture. We expect with our aging population to see a significant     increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic     patients are not diagnosed and do not receive treatment for their condition.      This research plan describes a study for clinical validation of the novel ultrasound device     (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated     in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n =     341 in total). Significant and good correlation was observed between Density Index (DI)     determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 -     0.70). In addition, with determination of 90% sensitivity and specificity thresholds,     significant number (65-75%) of patients could be diagnosed without additional verification     with DXA.      For validation of the technique in US population, our study plan is presented for     determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex,     lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140     men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury,     MN.        1. To investigate the capability of DI for prediction of proximal femur and lumbar spine          BMD;        2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status          with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis          is 20%) post-menopausal females (50-90 years);        3. To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;        4. To investigate correlation between lumbar spine or proximal femur BMD and Density Index          in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or          low bone mass. Determine diagnostic thresholds for DI in men.   "
103205|NCT01935219|"     The objective of this study is to assess the effectiveness of an intervention to address both     executive function and processing speed changes that contribute to poor driving performance     in adults with Mild Cognitive Impairment (MCI).      Our hypotheses are that the study intervention will improve performance on a driving     simulator and will improve (i) executive function, specifically attention and planning, (ii)     useful field of view, (iii) mood, (iv) quality of life, and (v) reported motor vehicle     crashes and driving infractions.   "
103206|NCT01935206|"     Recent studies have focused on the role of endogenous opioids on central sensitization.     Central sensitization is known to be impaired or altered in chronic pain conditions, as     fibromyalgia or chronic tension headache.      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone     administration after resolution of an injury. This suggests latent sensitization.      In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate     secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim     therefore to show that latent sensitization is present in humans and is modulated by     endogenous opioids.   "
103207|NCT01935193|"     The aim of the study is assessing the prevalence of aspirin resistance in a cohort of     diabetic patients. Those found resistant has been undergone pharmacological tests using     different drug formulations to investigate the reversibility of aspirin resistance.   "
103326|NCT01933633|"     Overweight/obesity is associated with sub-fertility. The investigators will assess if regular     exercise training prior to assisted fertilization will improve pregnancy rate in     overweight/obese women referred to assisted fertilization. It is expected that training will     be successful in increasing pregnancy rate   "
103208|NCT01935180|"     Effectiveness of screening colonoscopy in cancer prevention relies on the detection and     removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a     colonoscopy. It has been estimated that two thirds of missed adenomas are located on the     proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope may     allow examination of the proximal aspect of colonic folds, and some early studies have     suggested an increased polyp and adenoma detection using this technology. However, the     studies have in part substantial methodological limitations (e.g. missing polyp histology,     single endoscopist study, polyps not removed at the time of detection). Therefore, at this     point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The     objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma     detection.      The investigators propose a two-center multiple endoscopists randomized controlled trial.     Patients will be randomized to cap assisted colonoscopy or standard high definition white     light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached     to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean     number of adenoma per patient). The investigators will assess and adjust for possible     variables that can affect adenoma detection, including withdrawal time and quality of colon     preparation. As a secondary outcome of interest the investigators will evaluate a possible     learning curve effect among all endoscopists (a minimum of six) new to this method. In     addition the investigators will evaluate whether cap assisted endoscopy improves real time     prediction of polyp histology.   "
103209|NCT01935167|"     Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria     in Patients With Diabetic Nephropathy   "
103210|NCT01935154|"     Patients with stage IV or recurrent stage I-III NSCLC with documented disease control     (objective response or stable disease) within 3 weeks after platinum based 1st line     chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.      The objective of the trial is survival rate at 12 months.   "
103211|NCT01935141|"     With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed     in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be     done with less than the usual 80-120 ml of contrast used. We have developed a method of     performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most     patients. The long-term objective of this study is to show that there is no difference in the     diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional     full-dose technique.   "
103212|NCT01935128|"     The purpose of this study is to evaluate whether conversion to everolimus (Zortress®),     allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity     (measured by increased creatinine clearance) and lengthen overall graft (kidney transplant)     survival (measured by 2-3 year graft survival).   "
103213|NCT01935115|"     To determine the effect of ketamine, compared to propofol, when used an an anesthetic agent     for electroconvulsive therapy (ECT) in the treatment of major depressive disorder (MDD). We     hypothesize that ketamine, compared to propofol, will improve the the symptoms of MDD when     used as the anesthetic agent to facilitate ECT. Additionally, we hypothesize the dissociative     and cardiovascular effects of ketamine will be minimal.   "
103214|NCT01935102|"     Although many attempts have been done to identify vascular endothelial growth factor-A     (VEGF-A) single nucleotide polymorphisms (SNPs) correlated with bevacizumab response, in     advanced cancer patients, the results are still inconclusive.      We will conduct a pharmacogenetic study to assess, in a population of metastatic breast     cancer (MBC) patients, the possible predictive role of VEGF-A, VEGF receptor-2 (VEGFR-2),     interleukin-8 (IL-8), hypoxia inducible factor-1α (HIF-1α), hypoxia inducible factor-2α     (HIF-2α) and thrombospondin-1 (TSP-1) SNPs for bevacizumab response when combined with     first-line paclitaxel and for progression free survival (PFS). Analyses will be performed on     germline DNA obtained from blood samples and SNPs will be investigated by real-time     polymerase chain reaction (PCR) technique. The multifactor dimensionality reduction (MDR)     methodology will be applied to investigate the interaction between SNPs.   "
103215|NCT01935089|"     We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a     decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected     immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm,     open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects     (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y     with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.      We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV     reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or     immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir     in chronically HIV-infected, immune-reconstituted individuals.   "
103216|NCT01935076|"     The purpose of this study is to determine whether placental and umbilical cord blood miRNA     expression is altered in women with obesity with macrosomic neonates to when compared to     miRNA expression from control patients.   "
103223|NCT01934972|"     Individuals with bipolar suffer from problems in basic cognitive skills such as memory and     concentration. Unfortunately, there are no current treatments that have been shown to improve     cognitive skills among individuals with bipolar disorder.      Computerized cognitive remediation (CR) is a treatment that has been shown to improve     cognitive skills among individuals with serious mental illnesses other than bipolar disorder,     such as schizophrenia. This treatment involves completing a series of activities on a     computer that have been shown to improve cognitive skills.      D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis.     Recent studies have suggested that this drug may also improve individuals' ability to learn.     Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the     benefit that individuals receive from participation in cognitive remediation.      To test this hypothesis, approximately forty subjects will be randomized to one of two study     arms: [i] CR + DCS or [ii] CR + placebo. We will examine whether d-cycloserine increases the     benefit that individuals with bipolar disorder receive from participation in cognitive     remediation.   "
103640|NCT01929538|"     Benign biliary strictures caused by chronic pancreatitis can be endoscopically treated with     covered self-expandable metal stents (cSEMS).The purpose of the prospective randomized study     is to define the optimal duration of stenting and the diameter of the cSEMS.   "
103217|NCT01935063|"     Chronic pain problems involving the female reproductive system are major health concerns for     all women. Poorly understood, they entail great personal and financial cost. One such     condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%.     Despite its negative impact on psychosexual and relationship satisfaction, there is little     research examining empirically-tested treatments for afflicted couples. The proposed research     builds on findings from our work focusing on the impact of relational factors on vulvodynia,     and our previous research evaluating the efficacy of group cognitive-behavioral therapy for     this problem. This two-centre randomized clinical trial aims to assess the efficacy of a     novel, 12-week targeted couple therapy (CBCT) for women with vulvodynia in comparison to one     of the most commonly prescribed first line medical interventions, topical lidocaine. Primary     research question: Is there a significant difference between the two treatments on women's     pain during intercourse post-treatment? Secondary research questions will assess for     significant differences between the two treatments post-treatment and at 6-month follow-up on     multidimensional aspects of pain using the McGill Pain Questionnaire, women and partners'     sexuality (sexual function and satisfaction), psychological adjustment (anxiety, depression,     catastrophizing, self-efficacy, attributions, and quality of life), relationship factors     (partner responses, couple satisfaction, attachment, and communication styles), and     self-reported improvement and treatment satisfaction. Results of this study will improve the     health and quality of life of patients with vulvodynia by rigorously testing the efficacy of     a novel couples treatment.   "
103218|NCT01935050|"     The purpose of this project is to develop and pilot-test a guided cognitive-behavioral     self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will     pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The     manual will be revised based on participant feedback. Several feasibility measures regarding     the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness,     adherence) will also be assessed. Moreover, preliminary estimates of effect size for this     guided self-help program will be calculated and used in future research. We hypothesize that     people with PD will report decreases in depression, anxiety, and negative thoughts and     improvements in quality life and sleep and that caregivers will report decreases in burden     after participating in the guided self-help program   "
103219|NCT01935024|"     Exercise has been shown to be beneficial for the brain. The investigators would like to test     this specifically for those diagnosed with Alzheimer's disease. This study will involve 30     randomized patients to take part in the out-patient exercise program and 30 patients to     continue with their regular activities over a 6-month period. Once that period is over, half     of the 30 patients who participated in the outpatient exercise program will continue in the     program and the other half will be randomized to independently continue to exercise. The     investigators hypothesize that exercising will benefit the patient by slowing the dementia     process, improving behavioral symptoms, and decreasing volume loss of certain brain regions.     Each person will perform personalized exercise regimens, MR imaging and neuropsychological     tests will be used to measure the benefits of exercise. Ultimately, the hope is that the     results of this study could be used to facilitate exercise programs for patients. Enrollment     is completely voluntary and all personal data obtained will remain confidential.   "
103220|NCT01935011|"     The stimulation frequency has been found to affect the axial symptoms of freezing of gait     (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep     brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz     worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation     frequency on another important axial symptom, swallowing dysfunction, has not been studied.     The investigators hypothesize that stimulation frequency could have similar effect on     swallowing function.   "
103221|NCT01934998|"     The spinocerebellar ataxias (SCAs) are a genetically heterogeneous group of dominantly     inherited progressive ataxia disorders. More than 30 different gene loci have been identified     so far. The most common SCAs, which together account for more than half of all affected     families, are SCA1, SCA2, SCA3, and SCA6. Each of these disorders is caused by a translated     CAG repeat expansion mutation. SCA1, SCA2, and SCA3 usually have an onset between 30 and 40,     and SCA6 usually begins at the age of 50 to 60. In addition to progressive ataxia, SCA1,     SCA2, and SCA3 frequently present with additional non-ataxic symptoms, including     parkinsonism. Carbidopa/levodopa was found to have a good therapeutic effect on parkinsonism.      The SCA6 used to be considered a pure cerebellar disorder. However, a recent large study on     natural history of SCAs found that patients with SCA6 often had nonataxia symptoms, an     observation that challenges the view that SCA6 is a purely cerebellar disorder. Parkinsonism     in SCA6 was rarely reported, except in a case serial, or a small size study in Korean     patients.      Dopamine transporter (DAT) is a very reliable dopaminergic neuronal marker. Reduction in DAT     density detected by I123 SPECT DaTscanTM in the dopaminergic neuron terminal striatum was     reported in one small size study consisting of eight SCA6 patients in Korea. There was also a     PET study using different radioligand for DAT in a small group of SCA6 patients in Germany,     which found sub-clinical change in DAT density in some patients with SCA6.      There has been no study so far in the US on parkinsonism and other non-ataxia spectrum and     striatal dopaminergic damage in SCA6, probably because non-ataxia feature of SCA6 hasn't     received much attention, and also because DaTscanTM hasn't been clinically available in US     until recently. The only two published studies on SCA6 and DAT were from Korea and Germany,     which were of small subject size. There has been no treatment available for SCA6 so far.      Our hypothesis is that parkinsonism and other non-ataxia spectrum and striatal dopaminergic     neurodegeneration are part of the SCA6 disease spectrum.   "
103222|NCT01934985|"     The investigators propose a 4 year prospective, observational study of 40 patients yearly,     comparing conventional clinically indicated SPECT and PET perfusion with dynamic rest/stress     MPI studies with coronary angiography, in some cases performed with quantitative coronary     anatomy and flow as well as quantitative 13N-ammonia PET MPI. Methods will also be assessed     for their ability to determine myocardial viability by comparing regional wall motion (WM) on     clinically indicated serial ventriculography, echocardiography or gated SPECT MPI in those     protocol patients with WM abnormalities who subsequently undergo revascularization. Patient     studies will begin in the first study year based on those methods already developed and     integrate new advances as they become evident.   "
103224|NCT01934959|"     Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's     disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when     administered in adequate amounts, confer health benefit to the host.Based on this previous     knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the     gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the     incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators     conducted a prospective, multicenter, randomized and controlled trial to assess whether oral     probiotics could decrease the incidence and severity of Hirschsprung's disease associated     enterocolitis(HAEC).   "
103229|NCT01934894|"     This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients     with metastatic breast cancer (MBC) which has metastasized to the brain. The first portion of     the study will determine the optimal dose of the cabazitaxel/lapatinib combination to     administer to patients. After determining the optimal dose, patients will continue treatment     with cabazitaxel and lapatinib to assess response to treatment with these agents.   "
103230|NCT01934881|"     The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's     disease (PD) is complex work because the parameter setting has not been standardized so far.     The objective of the present study is to set up a standardized programming algorithm for     Chinese PD patients treated with bilateral STN DBS.   "
103231|NCT01934868|"     The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the long     term results of prolotherapy are more effective than those of the current conventional     treatment: epidural steroid injections (ESI). This research will examine the efficacy of     prolotherapy injections versus epidural steroid injections for the treatment of low back pain     radiating to the leg. This is a randomized, unblinded study, in which patients seen in the     principle investigator's pain clinic will be randomly divided to receive treatments from     either the experimental, prolotherapy group, or the active control, ESI group.   "
103232|NCT01934855|"     The main goal of this research is to characterize patient-specific respiration-induced tumor     and surrogate motion to evaluate the accuracy and effectiveness of the surrogate-based motion     management strategies currently used in clinics. Specifically, the investigators hypothesize     that dynamic MRI (Magnetic Resonance Imaging) obtained over a temporal duration consistent     with radiotherapy treatments will provide spatio-temporal information of both the tumor and     surrogate, and therefore can serve as a means to assess the quality of the tumor motion     tracking with the surrogate. To test this hypothesis, the investigators specifically propose     to 1) track and characterize the tumor and surrogate motion with 4D (4 dimensional)-MRI and     2) evaluate surrogate-based motion tracking in a cohort of patients with thoracic tumors.      External and internal surrogate-based strategies commonly used in clinics have not been     appropriately validated. With the increasing adaptation of these surrogate methods for motion     management, the proposed research addresses these urgent issues in clinical radiotherapy     while providing a means to achieve patient-specific motion management.   "
103233|NCT01934842|"     This study will compare blood collection from the forearm using an investigational device,     TAP20-C to blood collection from the finger tip. The blood collected from the forearm and     from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.   "
103234|NCT01934829|"     Although sorafenib is effective and safe in patients with advanced hepatocellular carcinoma     (HCC), it increases dermatologic toxicities, including hand-foot skin reaction (HFSR), which     may have a negative impact on patient quality of life (QoL). Urea-based creams may have a     prophylactic effect on sorafenib-induced HFSR in HCC patients.   "
103235|NCT01934816|"     This study aims to examine the involvement of KATP channels on the microvascular actions of     the incretin GLP-1 and its analogues in healthy individuals and to determine whether the     acute oral administration of different KATP channel blockers which are oral medications for     Type 2 diabetes such as Glibenclamide and Glimepiride differentially modulate the     microvascular responses in these individuals.   "
103236|NCT01934803|"     This study is a double-blinded randomized controlled trial (RCT) to assess the efficacy of     zinc supplementation vs. placebo among 250 HIV-infected Russians from the Russia ARCH Cohort,     who are ART-naive at enrollment and have a recent history of heavy drinking.   "
103237|NCT01934790|"     Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and     experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common     Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the     initial course of radium-223 dichloride that led to the discontinuation of treatment. 40     Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg     IV every 4 weeks.      The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit     every 4 weeks, prior to receiving radium-223 dichloride.      After the end of treatment visit the subjects will enter the active follow up period. Related     AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12     weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride.      After the 2 years of active follow-up, subjects will enter the long-term follow-up period and     will be followed via telephone follow-up at 6-month intervals for late toxicities and     survival up to 7 years after the last dose of radium-223 dichloride or until death.      Joint safety reviews will regularly take place to oversee safety of the subjects conducted at     regular intervals.      An interim analysis of the safety data will be conducted during the study.   "
103238|NCT01934777|"     The purpose of this interventional study is to evaluate the efficacy and tolerability of     docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with     well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).   "
103641|NCT01929525|"     Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be     investigated.   "
103239|NCT01934764|"     Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as a     co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins)     leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies.     Anti-biotin antibodies will be found in correlation with the progression and the present of     autoimmune disease. In this research the correlation between immune response against biotin     and the formations of autoimmune disease, will be studied:      A. Assessment of the possibility that biotin elicit immune response involved in the     developmental stage of the autoimmune disease.      B. Assessment of the possibility that anti-biotin antibodies indicate the developmental stage     of the autoimmune disease and therefore can serve as an disease early stage marker.      Methods: A. Patient recruitment. Gathering participant's medical record and blood samples. B.     Records of clinical and biochemical measures. C. Serum of all patient will be tested for the     correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to     liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated     self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E.     Determination of the correlation between biotinilated antibodies or anti-biotin antibodies to     disease eruption or severance and autoimmune disease.      Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are increased     in patients with active autoimmune liver diseases.      Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin     antibodies and autoimmune diseases will open new research direction of possible factors that     cause to autoimmune disease.      Probable implications to Medicine: Identification of correlations between reaction to biotine     and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases,     severity of the disease and personalization of treatment.   "
103500|NCT01931371|"     The purpose of this study is to determine whether anal fistula plug or endorectal advancement     flap is more successful in the treatment of anal fistulas and compared both procedures with     regards to cost.   "
103240|NCT01934751|"     Hypothesis: Patients who are addicted to opioids or alcohol will have reduced substance use,     health care utilization if they have immediate and convenient access to pharmacotherapy and     addiction counselling.      Summary: This randomized trial will compare two different interventions for 124 alcohol and     opioid-addicted patients admitted to either Women's Own Detox (WOD) at the University Health     Network or the Withdrawal Management Service (WMS) at Saint Michael's Hospital (SMH. The     Delayed Intervention group will receive a card with contact information for the St. Michael's     Hospital and Women's College Hospital addiction medicine services. The Rapid Intervention     group will be seen by an addiction physician from one of these services, within a day or two     of their admission to the WOD or the SMH WMS. The addiction physician will prescribe     buprenorphine or anti-alcohol medications, and the physician, nurse and/or therapist will     provide ongoing counseling, follow-up and shared care with the family physician. Outcomes     (measured at 6 and 12 months) include treatment retention, health care utilization and cost,     medications prescribed, and alcohol and opioid use.   "
103241|NCT01934738|"     The purpose of this study is to investigate safety, toleration and time course of plasma     concentration of multiple oral doses of PF-06273340 for 14 days in healthy subjects of two     age groups, aged 18-55 years (Group 1) and aged 56-75 years (Group 2)   "
103242|NCT01934725|"     BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes     occur at younger ages. Stroke at young age causes marked disability at worst and thus     long-standing socioeconomic consequences and exposes survivors for 4-fold risk of premature     death compared with background population. Up to 50% of young patients with ischemic stroke     remain without definitive etiology for their disease despite extensive modern diagnostic     work-up (i.e. cryptogenic stroke). The group of cryptogenic strokes includes those with     patent foramen ovale (PFO) or other abnormalities in the atrial septum in the heart as the     only or concomitant finding. Population prevalence of PFO is high, 25%, and the mechanisms     how PFO would be associated causally with ischemic stroke remain to be clarified. Moreover,     there are only scarce data on clinical outcome, long-term risk of new vascular events, and     prevention of such events in these patients.      DESIGN: Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the     Etiology, Triggers, and Outcome (SECRETO) is an international prospective multicenter     case-control study of young adults (age 18-49) presenting with an imaging-positive first-ever     ischemic stroke of undetermined etiology (aim N=2000). Patients are included after     standardized diagnostic procedures (brain MRI, imaging of intracranial and extracranial     vessels, cardiac imaging, and screening for coagulopathies) and age- and sex-matched to     healthy controls in a 1:1 fashion. Up to 45 study sites worldwide will be needed to recruit     the planned participant population during a 3-year period. Neurovascular imaging and     echocardiography studies, and ECGs will be read centrally.      AIMS: SECRETO involves five principal fields of investigation: (1) Stroke triggers and     clinical risk factors; (2) Long-term prognosis (new vascular events, functional and     psychosocial outcomes); (3) Abnormalities of thrombosis and hemostasis; (4) Biomarkers of     e.g. inflammation, atherogenesis, endothelial function, thrombosis, platelet activation, and     hemodynamic stress to characterize postulated cryptogenic stroke mechanisms; and (5) genetic     study, including genome-wide association and candidate gene studies as well as     next-generation sequencing approach. All analyses consider cardiac functional and interatrial     structural properties as a possible mediator. Furthermore, SECRETO Family Study (substudy)     aims at collecting extensive family history of thrombotic events from informative patients     being screened for SECRETO main study and collect genetic samples from all consenting family     members for whole-genome sequencing.      SIGNIFICANCE: SECRETO will provide novel information on clinical and subclinical risk     factors, both transient and chronic, predisposing to cryptogenic ischemic stroke in young     adults. This study also reveals long-term prognosis of this understudied patient population     and may discover new genetic background underlying the disease mechanism and provide     potential targets for drug development.   "
103243|NCT01934712|"     This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial     drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently     marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.   "
103244|NCT01934699|"     The investigators will compare myocard vitality diagnostics using 2D-Strain echography and     MRI.   "
103245|NCT01934686|"     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the     current status of diabetes management, control, and complications in diabetic subjects in     Indonesia.   "
103246|NCT01934673|"     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the     current status of diabetes management, control, and complications in subjects with type 2     diabetes in Malaysia.   "
103247|NCT01934660|"     Background:      - Cardiometabolic diseases are a combination of medical disorders that, when they occur     together, increase the risk of heart disease and diabetes. Researchers want to learn if there     is a relationship between these diseases and inflammation (redness, swelling, and pain).     Inflammation affects the entire body. Researchers will study this relationship in people with     heart disease and diabetes, and compare it to healthy people.      Objectives:      - To learn if there are links between inflammation and cardiometabolic diseases.      Eligibility:        -  Adults 18 years of age or older with heart disease or diabetes.        -  Healthy volunteers 18 years of age or older.      Design:        -  Participants will have up to six study visits. There will be first visit, then an          optional visit 12 months after the first visit.        -  At the study visits they will have:             -  Blood taken with a needle in their arm.             -  An electrocardiogram. Small patches are stuck to the chest and limbs. A machine               measures electrical signals of the heart.             -  Completed a number of questionnaires.             -  A body scan called an FDG PET/CT. A substance will be injected through a tube in               their arm. They will lie on a special bed that will move in and out of the PET/CT               scanner. The PET/CT scanner will take pictures of the body. The scan will last up               to 30 minutes.             -  Some participants will have other body scans ( FDG PET/MRI). The procedures are               similar to the FDG PET/CT scan. These other scans will last about 30 minutes total.             -  Some participants will also have a CT scan of their heart. A substance will be               injected through a tube in their arm. They will lie on a table in a large,               donut-shaped machine. An X-ray tube will move around their body, taking many               pictures. This procedure can last up to 2 hours.             -  Some participants will have tests that measures blood pressure and how the blood               moves through the body.             -  Some participants will have small samples of skin and fat tissue taken.   "
103248|NCT01934647|"     This clinical trial will study the safety, tolerability, and pharmacodynamics of single doses     of MK-8892 in participants with PAH. The primary objective is to estimate the measured peak     effect of the highest acutely tolerated (HAT) single oral dose of MK-8892 on pulmonary     vascular resistance (PVR).   "
103249|NCT01934634|"     The goal of this study is to identify the maximum tolerated dose and dose-limiting side     effects of LCL161 in combination with gemcitabine and nab-paclitaxel and to provide safety     data in patients with measurable metastatic pancreatic cancer.   "
103250|NCT01934621|"     Individuals with cognitive impairments after stroke sustain significant disability in their     daily tasks, and account for a significant proportion of stroke-related healthcare costs. The     proposed study examines a novel intervention, strategy training, that shows promise for     helping individuals with stroke-related cognitive impairments reduce disability in daily     tasks, which may lead to reductions in healthcare costs. We predict that strategy training     will result in significantly greater independence 6 months after stroke compared to an     attention control intervention, and that strategy training may reduce cognitive impairments.   "
103251|NCT01934608|"     To determine the effect of synchronizing a patient's prescription refill schedule on     medication adherence. The targeted population is Humana members who are currently taking 2 or     more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current     customers of RightSource. Participants will be randomized to one of two groups. Group one     will be usual care and group two will be the Rx synchronization group.   "
103252|NCT01934595|"     It is well accepted that during critical illness there is an increase in protein breakdown     and loss of lean body mass. Previous studies have shown that during critical illness muscle     breakdown increases dramatically. The aim of our study is to test the hypothesis that     critically ill patients have improved outcomes with higher protein supplementation.   "
103253|NCT01934582|"     A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients     transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily     dosing regimen.   "
103254|NCT01934569|"     This study will test the potential for PF-05089771 to interact with a cocktail of drugs   "
103277|NCT01934270|"     Proper growth in children is a complex process regulated by a combination of genetic,     nutritional, environmental, hormonal, and others. Growth hormone (GH) is the main hormone     regulating the growth from childhood to adulthood. Despite great progress in the field, with     the development of recombinant GH for the treatment of growth hormone deficiency (GHD), there     is still no reliable method for testing GHD. Physical exertion is one of the significant     physiologic stimuli for GH secretion, and it is reliable test for identification of GHD. It     is not in use in the clinics because of its complexity. Recently GH secretion following short     anaerobic exercise in young adults was tested and also demonstrated significant growth     hormone secretion      In contrast to adult children's exercise is characterized by an anaerobic nature. There is no     data about secretion of growth hormone in response to anaerobic exercise in children.      Purpose of the experiment:      The purpose of this study is to evaluate the secretion of growth hormone in response to     anaerobic exercise in children.   "
103256|NCT01934543|"     The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin     observed in patients with insulin-resistance is now thought to be attributable to both     elevated intestinal production and reduced clearance of these lipoproteins. Substantial     evidence exists indicating that elevated plasma levels of these lipoproteins are associated     with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma     TRL levels of intestinal origin appears to be crucial to improve CVD risk associated with     insulin-resistance. In this regard, there is some evidence that the clinical recommendation     to replace dietary saturated fatty acids (SFAs) by n-6 polyunsaturated fatty acids (PUFAs)     reduces CVD risk in the general population. Although the beneficial impact of n-6 PUFAs on     CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels,     recent data suggest that chronic n-6 PUFA consumption may also exert beneficial effects on     CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by n-6 PUFAs on     postprandial lipid response may be of even greater significance in dyslipidemic patients with     insulin-resistance among whom intestinal triglyceride-rich lipoproteins (TRLs) represent a     large proportion of the atherogenic lipoproteins. The general objective of the proposed     research is to investigate how dietary n-6 PUFAs in place of SFAs modify intestinal     lipoprotein metabolism in men with dyslipidemia associated with insulin-resistance. The     investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins     will be lower following a diet rich in n-6 PUFAs than after consuming a diet rich in SFAs.     The investigators also hypothesize that substitution of SFAs by n-6 PUFAs will be associated     with significant alterations in expression of key genes and proteins involved in intestinal     lipoprotein metabolism.   "
103257|NCT01934530|"     This randomized controlled clinical pilot trial compared the efficacy of two soft tissue     grafting methods for correcting esthetic discrepancies associated with non-molar implants in     the maxilla. Specifically, it was explored whether defects treated with connective tissue     grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix     allografts (ADM).   "
103258|NCT01934517|"     The purpose of this study is to evaluate the validity, reliability and reproducibility of     digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster     models.   "
103259|NCT01934504|"     The goal of the study is to find biological markers (certain proteins or cellular markers     found in a blood test) that will inform doctors which patients diagnosed with ANCA-associated     vasculitis (AAV) are most likely to be able to stop their medications suppressing their     immune systems and remain in remission.   "
103260|NCT01934491|"     This study is evaluating the effects of two brain training exercises on: memory, cognitive     processing and depression symptoms.   "
103261|NCT01934478|"     Based on fundamental study （in Vitro and in Vivo, Pro. Jianjian Li）， Her2 expression would be     changed from negative to positive by cancer irradiation with liner-accelerator at dose 6GY or     up. The propose of this study is to reveal the irradiation result on Her2 expression in human     breast cancer.   "
103262|NCT01934465|"     Investigators propose to assess, retrospectively and prospectively the safety and     tolerability profile (number of participants with adverse events) of standard chemotherapy     and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with     advanced or metastatic Non Small Cell Lung Cancer.      All treatment schedules that are going to be assessed are considered by the international     guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung     Cancer.   "
103263|NCT01934452|"     This prospective study will investigate the characteristics of mRCC patients at time of CR in     comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some     answers/ refection leads to the following questions :      Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with     sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report     these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify     potential predictive serum biomarkers of recurrence? (With the aim of isolating blood     biomarker that can help on treatment discontinuation decision?)   "
103264|NCT01934439|"     Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by     a chronic stroke.   "
103265|NCT01934426|"     Objective: The study aim to establish high risk admission model and readmission model for     elderly in Taiwan.      Method: Investigators compare the clinical, epidemiological, and socioeconomic     characteristics of admitted patients during 1 August,2011 to 31 July,2012. All patients will     follow up to end of study to identify 14 days readmission and 30 days readmission to geriatic     ward.      Expected Outcomes: (1) To compare the prediction value of derivation cohort and validation     cohort. (2) To identify high risk indicators of admission and readmission for elderly. (3) To     determine the risk factors in admission elderly association with quality indicators.   "
103266|NCT01934413|"     The purpose of this pilot study is to develop and test a technology-enhanced transitional     palliative care (TPC) intervention for patients and caregivers living in rural locations. The     investigators hypothesize that access to palliative care will be improved, thereby improving     patient and caregiver reported outcomes and decreasing the use of costly health services.   "
103267|NCT01934400|"     Objective: The study is to increasing osteoporosis awareness with fracture risk assessments     and management as well as fall prevention among elderly in northern region of Taiwan.      Method: Six community osteoporosis and fall prevention educational programme will be held at     northern region of Taiwan. A questionnaires design including demographic variables , FRAX     variables, nutritional variables and osteoporosis and fall knowledge variables as well.The     pretest-posttest method was used to analyse the effect on education.      Expected outcomes : (1)Fall prevention educational programme will hold in northern region of     Taiwan at different communities in order to increasing osteoporosis awareness with fracture     risk assessment tool, establishing fall knowledges among elderly and some fall prevention     skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than     20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk     of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend     for BMD measurement.   "
103276|NCT01934283|"     Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post     operative adhesions and most of them resolve without the need of surgical intervention. The     most important thing dealing with SBO is to identify the more complex obstructions that need     surgery.      Some clinical, physiological and radiological signs are recognized as markers of a more     complex obstruction.      The pathophysiology of bowel obstruction is explained as damage created by pressure on the     abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure     intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction.      In this study we will measure the intra-abdominal pressure in SBO patients systematically and     we will examine if more severe obstructions are accompanied by elevated intra-abdominal     pressure.   "
132427|NCT01551615|"     Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone     and In Combination with Vandetanib   "
103268|NCT01934387|"     BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese     calculator is freely available on line to help osteoporosis management. However, its clinical     utility for improving osteoporosis awareness and patient acceptance has not been validated in     Taiwanese population.      OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults     participating in the geriatric health examinations (GHEs) at the National Taiwan University     Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to     improve patient awareness in osteoporosis. The second aim is to look for the recommendations     from the participating physicians to improve the FRAX® -based osteoporosis management model.      METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting     annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE     visits after informed consent. Baseline questionnaires including the FRAX® tools will be     distributed and expected to be returned at the stage 2 visits. Research assistants will     calculate the 10-year predicted fracture risks for the participants during the waiting     periods and present the numbers to the GHE physicians. High risks individuals will be     referred to general geriatric clinic for further managements. All participants will be     provided with osteoporosis and fracture educational material. Patient acceptance and     awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll     roughly 1,800 older adults assuming refusal rate about 40%.      Qualitative interviews will be used to obtain recommendations from study geriatricians in     Jul., 2013 to optimize the FRAX® based screening and management model.   "
103269|NCT01934374|"     Task-oriented exercises combined with strengthening have been shown effective in improving     walking functions in patients with chronic stroke. However, similar approaches of therapeutic     exercises have not been applied to subacute stroke with long-term follow-up, using outcome     measures across the three levels of functioning (body functions/structure, activities, and     participation) of the International Classification of Functioning, Disability, and      Health (ICF) model. Therefore, this study will be conducted to fulfill three purposes:        1. To investigate the long-term effects of a four-week task-oriented lower extremity          strengthening training (TOLEST) program in patients with subacute stroke;        2. To investigate the interrelationships among functional connectivity of the brain, lower          extremity motor functions, physical activity level, and quality of life in patients with          stroke who have received this four-week TOLEST program in the subacute phase of stroke;          and        3. To identify prognostic factors for recovery in functional connectivity of the brain,          lower extremity motor functions, physical activity level, and quality of life in          patients with stroke who have received this four-week TOLEST program in the subacute          phase of stroke.   "
103270|NCT01934361|"     This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent     glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated     dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with     every-three-week carboplatin or buparlisib once daily in combination with every-six-week     lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2     arms, the corresponding phase II portion of the study was to start. Phase II was to assess     the treatment effect of buparlisib in combination with carboplatin in terms of Progression     Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine     versus lomustine plus placebo in terms of PFS.   "
103271|NCT01934348|"     This study aims to implement and refine research protocols required for a full-scale     randomized controlled trial of Psychological First Aid (PFA) for adult victims of crime. PFA     is a promising acute intervention designed to reduce the severity and duration of     trauma-related distress. Law Enforcement Victim Advocates are being trained to implement PFA     with adult crime victims. A pilot trial is comparing PFA to usual victim advocacy services on     key psychiatric outcomes from baseline through 4 months post-baseline.   "
103272|NCT01934335|"     The purpose of this research study is to test whether vandetanib has an effect on tumor     growth markers. Vandetanib is not approved by the FDA for use in treating breast cancer. This     study will compare vandetanib to a placebo.      The proposed study is designed to determine the change in Ki-67 expression on paired breast     cancer samples obtained before and after treatment with vandetanib. Other tumor markers     including RET, TUNEL and phosphorylation specific levels of ERK1/2, AKT and mTOR will also be     assessed on the paired samples.      Subjects who have a core biopsy of the breast which demonstrates invasive breast cancer and     requires surgical excision of the lesion will be eligible for inclusion in the study. The     tyrosine kinase inhibitor, vandetanib 300 mg, will be given once a day for 7-14 days prior to     surgery. Following surgery, tissue markers would be analyzed on each of the paired samples,     allowing for rapid assessment of in vivo response to TKI treatment.   "
103273|NCT01934322|"     The purpose of this study is to evaluate a specific case management intervention for frequent     users (FU) of Emergency Department (ED).      Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable     patients because they are more likely to be of low social and economical status, be more     isolated and live alone. They report more chronic medical conditions, have a higher mortality     rate and consume more healthcare resources.      In the literature, interventions aimed at improving the management of ED-FU have demonstrated     several positive outcomes, but there are still some knowledge gaps.      The proposed project tests the hypotheses that case management intervention as compared with     standard emergency care        -  is a more efficient use of healthcare resources and reduces ED attendance,        -  is cost-saving and        -  improves quality of life,        -  altogether leading to favorable cost-utility ratio.   "
103274|NCT01934309|"     The purpose of this study is to evaluate the impact of implementing a clinical decision     support reminder system for medical providers (i.e., nurses, clinical officers, medical     officers, consultants) to improve tuberculosis case-ﬁnding and the use of isoniazid     preventative therapy for adults living with HIV in western Kenya.   "
103275|NCT01934296|"     The purpose of this study is to use an investigational device to record brain activity for     12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The     goal of the study is better understanding of brain activity in movement disorders and how     they relate to DBS, not to bring new devices to market.   "
103642|NCT01929512|"     To compare the pharmacokinetic characteristics between HCP1201 tablet 750/20 mg and     co-administration of metformin 750 mg plus rosuvastatin 20 mg under fasted and fed state,     respectively.   "
103280|NCT01934231|"     Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in clinical     practice, which has with respiratory symptoms including nasal congestion, rhinorrhoea,     postnasal discharge and cough and is associated with headache, cheek pain, facial pressure     and other conditions. The principal bacterial pathogens in causing ABRS include Streptococcus     pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. These three     bacteria account for approximately 90% of ABRS in children less than or equal to 5 years of     age. Combination of Potassium Clavulanate (CVA) and Amoxicillin (AMPC) produces higher     antibiotic activity against beta-lactamase-producing bacteria. The present study is designed     to assess the clinical efficacy, bacteriological efficacy and safety of CVA/AMPC (1:14)     administered in children aged from 3 months to less than 15 years with ABRS. It is an     open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase     for 7 to 14 days.   "
103281|NCT01934218|"     The purpose of this study is to determine whether Gel-One demonstrates a superior     effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS)     injections.   "
103282|NCT01934205|"     Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations     in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid     (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and     alveolar macrophages represent an ideal estimate of concentrations at the site of infection     and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial     concentrations via BAL is not routine in clinical practice due to its complex methodology and     poor patient tolerability. This study will evaluate intrapulmonary and plasma     pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a     Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following     intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate     the single dose PK profiles. Part B is optional and will only be conducted if necessary. Each     part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be dosed     initially; cohorts 5 and 6 are optional and will only be dosed if additional time-points are     necessary to adequately model the pulmonary pharmacokinetic profile.   "
103283|NCT01934192|"     This is a multi-center, parallel group, placebo-controlled and active-compared, randomized     study to assess the ability of GSK962040 to enhance the delivery of enteral feed to     critically ill subjects that are predisposed to developing feeding intolerance (e.g.,     percentage of goal volume); enhance gastric emptying in this population; and provide     preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the     Intensive Care Unit [ICU], time on ventilator, ICU acquired infections, and 60-day     mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics     upon repeat dosing in a critically ill population.      After meeting eligibility criteria, male and female subjects will be randomized to either     receive GSK962040 (50 milligram [mg]) once daily (OD) via naso-gastric (NG) or orogastric     (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop     intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive),     study treatments will switch such that those originally receiving GSK962040 will receive     metoclopramide (10 mg, intravenous [iv], every 6 hours) and those subjects originally     randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if     subjects develop intolerance prior to any treatment, they will be randomized to receive     either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours).      The study will consist of a screening/baseline assessment, a treatment period (up to 7 days     in duration), and a 4-day post treatment safety follow-up assessment. The duration of each     subject's participation in the study from screening to follow-up safety assessment will be up     to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to     the ICU.   "
103284|NCT01934179|"     This pilot research trial studies telomere length in predicting toxicity in older patients     with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from     patients with cancer in the laboratory may help doctors learn more about changes that occur     in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.   "
103285|NCT01934166|"     To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene   "
103286|NCT01934153|"     The purpose of this study is to characterize the pharmacokinetics (PK), safety and     tolerability of topically applied umeclidinium following single dose topical administration.     The results from this study will be used to 1) improve our understanding of the risk of     systemic accumulation upon chronic administration, 2) support dosing recommendations in a     2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study for     palmar administration, and 3) confirm whether the same formulation can be used for axillary     and palmar application for the next studies.   "
103321|NCT01933698|"     The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the     bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian     volunteers.   "
103287|NCT01934140|"     The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9     to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY     when given to healthy subjects 11 to 55 years of age. In addition, the safety and     immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects     10 years after the primary vaccination will be evaluated.      All Filipino subjects who received the primary vaccination in the primary vaccination study     107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase.     No new subjects will be enrolled.   "
103288|NCT01934127|"     The purpose of this study is to evaluate the safety and immunogenicity of different     formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The     study will evaluate safety related events and antibody immune responses to different     formulations of study vaccine and placebo.   "
103289|NCT01934114|"     The purpose of this study is to determine whether an experimental alternative imaging method,     Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory     system to examine the breasts for cancer. The NIR system uses light beams to produce an image     or picture of the inside of the breast. The respiratory system will help researchers get more     information about the breast tissue by changing the amount of oxygen the tissue receives     during NIR imaging.   "
103290|NCT01934101|"     Primary Objective:      • To determine the safety and tolerability of single and multiple ascending oral doses of     CHR-5154 in healthy volunteers.      Secondary Objectives:        -  To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.        -  To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of          CHR-5154 in the fed and fasted state.   "
103291|NCT01934088|"     Sedation for endoscopy is a service more than a necessity. Therefore it should be patient     driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic     control. Therefore, satisfaction with the procedure experience is paramount for patients with     IBD. Investigators wish to study the feasibility and the effect on patient experience of two     drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a     combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with     propofol has a better procedure experience, that a well performed sedation equals a better     experience and that NAPS is as feasible as fentanyl with midazolam sedation.   "
103292|NCT01934075|"     The purpose of this study is to determine whether a mental health intervention for obstetric     fistula patients in Tanzania improves primary outcomes (depression, PTSD and somatic     symptoms) and secondary outcomes (coping, perceived stigma, social support, social     participation, efficacy to engage with providers, adherence to clinical recommendations and     social reintegration).   "
103293|NCT01934062|"     This is a retrospective chart review to assess the incidence and the degree of blood pressure     changes after induction of anesthesia and to study the effect of different induction agents     on blood pressure.   "
103294|NCT01934049|"     Hip fractures incidence grows rapidly with the aging of the population. After indicated     surgical treatment, hip fracture patients experience high rates of postoperative     complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD),     leading to poor postoperative recovery during hospitalization, which can cause disability,     distress for both patients and their families, are associated with other medical     complications and account for significant additional health care costs. We currently use     dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in     order to improve postoperative recovery and prevent and treating PD and POCD.      Dexmedetomidine is a drug used for sedation in critically ill patients that provides some     pain relief and controls the bodies response to stress. The sedation produced by     dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia     and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium     following cardiac surgery and the developing understanding of the causes of PD and POCD     suggest that dexmedetomidine will be particularly effective.   "
103295|NCT01934036|"     The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on     anthropometric and physiological variables in Spanish women between 35 and 60 years who are     overweight or obese.   "
103296|NCT01934023|"     This laboratory pilot study will explore the effects of varenicline tartrate on long-term     potentiation (LTP)-like mechanisms of (1) the motor cortex and (2) the dorsolateral     prefrontal cortex (DLPFC) and working memory in non-smoking patients with schizophrenia and     healthy controls using a Paired Associative Stimulation (PAS) method. The present study will     use this novel PAS method to evaluate the effects of five doses of varenicline (Champix) 0.5     mg BID treatment on neuroplasticity changes and working memory in 28 non-smokers with     schizophrenia and 28 non-smoking controls in a placebo-controlled, double-blinded, cross-over     design. The hypothesis is that varenicline will increase LTP-like facilitation of the DLPFC     as compared with placebo in patients with schizophrenia, with less or a null effect in     healthy controls. Likewise, it is hypothesized that varenicline will specifically improve     working memory in patients with schizophrenia as compared with placebo and healthy controls.     We Hypothesize that: 1.Patients with Schizophrenia(SCZ) will have reduced cortical LTP and     impaired working memory compared to healthy controls 2. Sub-chronic varenicline challenge     will attenuate the cortical LTP and working memory deficit in patients with SCZ. 3.Reversal     of the cortical LTP deficit by varenicline in patients with SCZ will be associated with     improvement in working memory.   "
103297|NCT01934010|"     The purpose of this research study is to test the safety and local tolerance of repeated     treatment cycles of AM-101.   "
103322|NCT01933685|"     The purpose of this study is to define the immune responses induced by a HIV vaccine, AIDSVAX     B/E. Blood and mucosal samples will be collected to assess immune responses.   "
103323|NCT01933672|"     Study B1621019 will assess efficacy and safety of two different dosing regimens of an     investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients     with type 2 diabetes   "
103348|NCT01933347|"     The purpose of this study is to evaluate the disease control rate (DCR) of gefitinib as     third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation     patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R positive     mutation and tumor progression after the second-line chemotherapy   "
103298|NCT01933997|"     objective: To assess the safety, tolerability and pharmacokinetics of metadoxine,     administered as repeated oral doses of MG01CI tablets (2 X 700 mg metadoxine per     administration), to healthy adult subjects.      This is a single center, open-label, repeated-dose study in healthy male and female     volunteers. Subjects will undergo screening within 21 days prior to the first dosing to     assess their eligibility to participate in the study.      All subjects will receive 1400 mg metadoxine as two MG01CI oral extended-release tablets,     administered once daily for five consecutive days.      Blood samples for metadoxine (which consists of two components: pyrrolidone-5-carboxylate and     pyridoxine that can be identified in plasma concentration assays) will be drawn at designated     time points, as described in the pharmacokinetic (PK) evaluation section. The subjects will     remain confined to the unit for 6 days after first dosing.      A study termination visit will take place 10-12 days after the last dosing day. The subjects     will be monitored for safety, and AEs (Adverse events) will be recorded throughout the study.   "
103299|NCT01933984|"     This study evaluates whether individualized dosing schedule of inhaled bronchodilator is more     effective than fixed dosing in reducing airway resistance of intubated COPD patients.   "
103715|NCT01928563|"     This study is designed to investigate the pharmacokinetic drug interaction between Udenafil     and Dapoxetine in healthy male subjects      Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study      Investigational Product : Udenafil, Dapoxetine   "
103300|NCT01933971|"     Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the same     active content as Neupogen®. BK0023 is expected to have the same tolerability profile and     clinical effects as Neupogen® in controlling myelo-toxicity induced by chemotherapy given for     the treatment of solid and haematological tumours. It is worth noting that the production and     manufacturing procedures allow to have a reduction of drug cost thus it is likely to have     pharmacoeconomic advantages.      The study is aimed at investigating the pharmacodynamic equivalence and the pharmacokinetic     bioequivalence of the new BK0023 injectable formulation of filgrastim 0.3 mg/mL by Bio-Ker     S.r.l. vs. the comparator (Neupogen® 0.3 mg/mL, Dompé Biotec S.p.A., Italy). Healthy male     subjects will receive test and reference at the doses of 2.5 and 5 µg/kg/day for 7     consecutive days and at the dose of 10 µg/kg/day for 5 consecutive days according to a     randomised cross-over design. Pharmacodynamics, pharmacokinetics and safety of BK0023     injectable formulation 0.3 mg/mL and of Neupogen® 0.3 mg/mL, administered in 2 consecutive     periods with a wash-out of at least 28 days elapsing between the last injection of period I     and the first of period II, are compared.      Study design: Single and multiple escalating dose, double-blind, randomised, two-way     cross-over, pharmacodynamic and pharmacokinetic bioequivalence study.   "
103301|NCT01933958|"     The objective of this study is to assess safety and effectiveness of Regorafenib using in     real clinical practice   "
103302|NCT01933945|"     This study will collect data of patients who are treated with TACE followed by sorafenib for     hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a     prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was     documented retrospectively, this study will collect more detailed information about the TACE     treatment and the status of a patient when treatment with sorafenib is started.   "
103303|NCT01933932|"     The purpose of this study is to assess the efficacy of selumetinib in combination with     docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with     locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also     assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the     selumetinib/docetaxel combination, compared to placebo in combination with docetaxel   "
103304|NCT01933919|"     The objective in 1st phase of this randomized study is to evaluate the efficacy of SME3110     compared to placebo on change in total score of Japanese version of the Children's Yale-Brown     Obsessive Compulsive Scale 10-item for children from baseline to the last observation visit     in pediatric/adolescent Obsessive Compulsive Disorder subjects in short-term (10 weeks) in     double blind period. The safety of SME3110 compared to placebo is also evaluated.      The objective in 2nd phase of the study is to evaluate the long-term safety and efficacy of     SME3110 in pediatric/adolescent Obsessive Compulsive Disorder subjects.   "
103305|NCT01933906|"     In this phase I pilot study, it is planned to investigate the feasibility and safety of     adding an interferon therapy to an preexisting imatinib treatment in patients with chronic     phase chronic myeloid leukaemia. The participating patients have already reached a response     during their imatinib therapy (CCyR) but have still a detectable disease (no molecular     response MR 4.5 or better).   "
103306|NCT01933893|"     Pipelle was found to increase pregnancy and implantation rates in women undergoing IVF     treatment in general, and in particular in repeated implantation failure (RIF). However,     there is virtually no data regarding the optimal timing for the pipelle.      The current study aims to compare between follicular and luteal pipelle on pregnancy rate in     RIF patients.   "
103307|NCT01933880|"     The purpose of this long term post-marketing study is to evaluate the effectiveness and     safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in     participants with Attention Deficit Hyperactivity Disorder (ADHD).   "
103308|NCT01933867|"     Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of     lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel     diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our     preliminary experience, water immersion could be beneficial while scoping these patients. As     far as the investigators know, water-aided colonoscopy has never been studied in this     indication. Results of our trial might support use of water-aided colonoscopy in common     practice and decrease associated discomfort in IBD patients.   "
103309|NCT01933854|"     The investigators aim to study the prevalence of urinary incontinence in women who live in     the riverside community in the state of Amapa (The Bailique Island) and compare it to the     prevalence of urinary incontinence in women who live in the urban region -Macapa-the capital     city of the Amapa State - Brazil.   "
103324|NCT01933659|"     Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and     minerals and is obtained from the water flows 200 meters under the surface of the sea. The     inhibition of H. pylori growth by DSW has been demonstrated in vitro study. However, up to     now, there is few randomized control study to evaluate the anti-bacterial effects of     ingesting DSW in patients with H. pylori infection.      The aims of this study are:        1. to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori          infection;        2. to evaluate the patient adherence and adverse effects of ingesting DSW.   "
103310|NCT01933841|"     Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative     tools, but their use carries the potential risk of serious postoperative complications.     NMBD-induced muscle weakness that lingers into the postoperative period, known as     postoperative residual curarization (PORC), is present in as many as 40% of all patients that     receive neuromuscular blocking agents. The Post Anesthesia Care Unit will be introducing     monitoring as part of standard of care. This study will collect data about patients who     receive NMBDs and examine the impact of monitoring on incidences of PORC.      Our study is designed to test the following hypotheses:      Hypothesis 1: The initiation of quantitative TOF monitoring as part of the standard PACU     entry evaluation will change practitioner behavior in a manner that decreases the incidence     of PORC in surgical patients at VUMC.      Hypothesis 2: The initiation of the routine TOF monitoring program will decrease the     incidence of short- and long-term postoperative complications at VUMC.   "
103749|NCT01928121|"     The purpose of this study is to assess the effectiveness of a newly developed     interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a     prospective, pragmatic clustered randomized controlled trial will be performed in general     practices.   "
103311|NCT01933828|"     In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A     resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open procedure     by thoracotomy for patients with early stage lung cancer, but randomized evidence for     superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation yet.     The objective of this study is to assess the benefits of VATS- over open lobectomy regarding     quality of life and costs in a prospective randomized controlled multicenter trial. All     patients meeting the inclusion criteria that are not randomized will be included in a     prospective Cohort.   "
103312|NCT01933815|"     This trial is divided into two parts, a dose-escalation study (phase 1) and a randomized     study (phase 2).      The purpose of the dose-escalation study (phase 1) is to determine the safety, maximum     tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in     subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation     therapy and temozolomide (TMZ).      The purpose of the randomized study (phase 2) is to determine the safety and efficacy of the     phase 1 MTD of TPI 287 in combination with bevacizumab versus bevacizumab alone in subjects     who have GBM that has progressed following prior radiation therapy and TMZ.   "
103313|NCT01933802|"     The study is an open-label, phase I clinical trial designed to evaluate the safety and     tolerability of intrathecal administration of autologous mesenchymal stem cell-derived neural     progenitor cells (MSC-NP) in patients with progressive multiple sclerosis. Study participants     will receive three intrathecal injections of culture-expanded autologous MSC-NPs at three     month intervals.   "
103314|NCT01933789|"     The purpose of this study is to improve care delivered to patients with serious illness by     enhancing communication among patients, families, and clinicians in the outpatient setting.     We are testing a new way to help patients share their preferences for talking about     end-of-life care with their clinicians and families. To do this we created a simple, short     feedback form. The form is designed to help clinicians understand what patients would like to     talk about. The goal of this research study is to show that using a feedback form is possible     and can be helpful for patients and their families.   "
103315|NCT01933776|"     The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of     participants in China.      Primary objective:        -  To describe the safety in terms of occurrence of serious adverse reactions and grade 3          adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given          as a single dose in 20 adults and 20 children.      Secondary objective:        -  To describe the full reactogenicity profile after administration of sanofi pasteur's          Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.   "
103316|NCT01933763|"     Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy     volunteers.   "
103317|NCT01933750|"     Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision     in patients who require reading glasses   "
103318|NCT01933737|"     The elderly population has increased significantly in the last years. The number of falls has     also increased due to the decrease of balance. The Kinesio Taping (KT) is a method with the     aim to improve muscle physiology, proprioception, coordination and balance. The aim of the     study was to investigate the effect of KT on postural balance in the elderly. We evaluated 62     elderly with a mean age of 67.98±5.321, female, submitted to the protocol for the application     of KT in gastrocnemius muscles of the midfoot and a placebo tape (3M Micropore) in the     control group. The application of the tapes was bilateral. Half of the participants (n=31)     received KT in the lower limbs, while the control group (n=31) was applied placebo tape. To     analysis of posture and balance, we used a force plate to record stabilometric signals. Both     groups were evaluated post-application and 48 hours after application of the tape. The     variables used were total displacement in centimeters (cm), amplitude AP (anterior-posterior)     and ML (medial-lateral) in centimeters, area (cm²) and speed AP and ML in centimeters for     seconds. The experimental protocol was performed in standing posture and the subjects were     instructed to stand with feet apart, eyes open to look at the fixed point 1.5 m from force     plate in a horizontal direction. It was requested that the elderly maintain the position for     a time of 40 seconds to collect data The data were collected immediately post application of     tapes and after 48 hours. The data was tabulated, descriptive statistics were calculated.     Statistical analysis was performed using the GraphPad Prism 4.0 software (Prism, Chicago,     IL). The Kolmogorov Smirnov test was used to verify the data distribution. Differences     between the means were evaluated using the Student T test for the normally distributed data,     and using the Mann-Whitney test for the data not normally distributed. Significance levels     were set at p<0.05.   "
103319|NCT01933724|"     This is a randomized controlled trial in patients with a diagnosis of granulomatosis with     polyangiitis (GPA; Wegener's)that are in remission to evaluate the effects of using low-dose     glucocorticoids ( 5 mg/day of prednisone) as compared to stopping glucocorticoid treatment     entirely (0 mg/day of prednisone)on rates of disease relapse/disease flares.      This study is a novel approach to conducting a randomized clinical trial in the community     setting. This study is being conducted in parallel with a similar study at established     vasculitis institutions. This study will have a patient centric approach to research in that     subjects will be recruited online and through social media and vasculitis support networks.     Participants will be consented online and will receive care through their regular treating     physician so no travel or additional doctor visits are required. Study participants will     consent to the study and complete online questionnaires about their prednisone dose and about     how they are feeling.   "
103320|NCT01933711|"     Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by     prolonged exposure to the drug. To test for this hypothesis we performed a prospective     randomized trial of rituximab maintenance therapy versus observation in patients (pts) with     aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.   "
135463|NCT01511705|"     This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single     dose, crossover, oral bioequivalence study.   "
103396|NCT01932723|"     Menstrual low back pain (LBP) is one of the common complaints among women. Menstrual LBP may     be attributed to the spinal instability resulting from ligament laxity due to hormonal     change. The purpose of this study was to investigate the effect of functional lumbar     stabilization exercises on pain, disability and kinesiophobia in women with menstrual LBP.   "
103425|NCT01932346|"     Near infra-red spectroscopy (NIRS) was used to measure the tissue perfusion of the cerebral     cortex with two noninvasive adhesive patches in recent years. This study is designed to     compare the regional tissue perfusion of different body areas in patients receiving coronary     artery bypass surgery under general anesthesia. The NIRS data will also be used to compare     with other routine physiological monitors in the surgery.   "
104681|NCT01915940|"     The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is     non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.   "
103327|NCT01933620|"     Background:      - The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every     person s body contains microorganisms like these. They normally do not make people sick.     Researchers are interested in how these microorganisms change when a person is hospitalized.     They want to find out if changes take place because of the hospitalization (such as     treatments used or changes in medical condition) or because of a person s biology (such as     their immune system).      Objectives:      - To understand which microorganisms are most likely to spread through hospitals and what     affects that spread.      Eligibility:      - People over 2 years of age who are going to be inpatients at the National Institutes of     Health Clinical Center (NIHCC) for at least 1 week.      Design:      - Clinicians will take samples from participants up to once a day for as long as they are     hospitalized at NIHCC.      <TAB>- Blood will be taken from a needle in the arm. This will be done only once, unless the     participant gets a certain infection.        -  Swabs will be taken with a cotton swab, from the rectal area, groin, throat, and armpit,          and possibly other areas.        -  Participants may give a stool sample or be asked to spit into a cup.        -  Clinicians will collect some information from participants medical records. They may          request some samples of tissue that are left over from procedures already scheduled at          NIHCC.        -  After participants leave the NIHCC, samples may be taken when they return for follow-up          visits from their hospitalization, for up to 2 years. They will not have to return as a          follow-up for this study only.   "
103328|NCT01933607|"     The study is being conducted to evaluate look the TOPS System when used in patients with     degenerative spondylolisthesis and lumbar spinal stenosis who would normally be candidates     for spinal fusion.   "
103329|NCT01933594|"     Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot     cure HIV infection because a small amount of virus remains in cells as a hidden (latent)     form. The purpose of this study is to evaluate the safety and efficacy of single dose and     multiple dose administration of romidepsin (RMD) in HIV-infected adults.   "
103330|NCT01933581|"     Coronary artery disease and heart attacks are the leading cause of death in the UK. Our     population is ageing. The number of older patients suffering heart attacks and having     angioplasty procedures to open up blocked heart arteries is increasing. After angioplasty,     older patients (80 years of age or over) are at 5 times increased risk of death at one year     compared to their predicted normal life expectancy. In addition, many patients present with     further heart attacks, stroke and undergo repeat heart catheter test and angioplasty     procedures. At present it is not clear who will or will not experience further problems in     the future. The ability to predict who will and will not suffer future problems at the time     of initial presentation can be helpful in providing additional treatment and close monitoring     to those that are at risk of further problems. The ICON 1 study is set out to study just     that. In this study, older patients will undergo a comprehensive evaluation of the     cardiovascular disease burden by undergoing additional investigations. These results from     each patient will be used to develop a risk score that will inform physicians of the     patient's future risk of developing adverse events and provide a better understanding of how     to manage older patients with coronary artery disease and also help plan future studies     looking at treatment strategies that might be beneficial in improving outcomes.   "
103331|NCT01933568|"     A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to     treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal     lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent     chemotherapy. It is hypothesized that this will lead to an increase of local control and     overall survival   "
103332|NCT01933555|"     Although domestic violence is recognized as major threat in pregnancy, there is no     intervention has been developed or test to support women in India. To evaluate the effect of     women's empowerment program administered to abused women in order to reduce domestic abuse,     improving health status and safety behavior.   "
103333|NCT01933542|"     Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the     resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose     is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after     spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce     opioidconsumption and side effects compared to placebo.   "
103334|NCT01933529|"     The purpose of this study is to determine whether a non-hematopoietic erythropoietin     analogue, ARA 290, exerts beneficial effects on blood glucose levels and insulin secretion in     persons with prediabetes (impaired glucose tolerance, IGT, or impaired fasting glucose, IFG),     or drug-naive type 2 diabetes.      The study will also evaluate effects of ARA 290 on insulin sensitivity and serum levels of     inflammatory agents, e.g. cytokines. In addition, safety will be monitored by following     parameters related to hematology, kidney and liver function and lipid levels.   "
103335|NCT01933516|"     The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese     patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing     schedule.   "
103336|NCT01933503|"     This is a single center, open label, randomized, parallel design, single and multiple dose     trial to evaluate the pharmacokinetics(PK), safety and tolerability of obeticholic acid     (OCA).   "
103337|NCT01933490|"     Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring     in some patients after gastric bypass surgery for obesity. The pathogenesis is incompletely     understood but involves a robust insulin response to ingested carbohydrate. The resultant     hyperinsulinemia sometimes produces hypoglycemia with neuroglycopenia, confusion and even     loss of consciousness. Various treatments have been recommended including low carbohydrate     diets, coingestion of the medication acarbose with carbohydrate containing meals, partial     pancreatectomy and even total pancreatectomy. None is completely satisfactory. We propose to     test two new potential treatments. Using a design with random assignment of three conditions     we plan to compare, in 10 patients with post-gastric bypass hyperinsulinemic hypoglycemia, a     high carbohydrate test meal (control condition), a high carbohydrate test meal after     pre-treatment with rapid acting aspart insulin (insulin condition), and a high fructose, low     glucose test meal with carbohydrate and caloric content similar to the control meal (fructose     condition).   "
135464|NCT01511692|"     This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects     of liraglutide on energy intake in subjects with type 2 diabetes.   "
103338|NCT01933477|"     The purpose of this study is to understand how to improve health care services for     HIV-positive women during their pregnancy and after delivery. The study's aim is to compare     two different ways of providing antiretroviral therapy for pregnant women with HIV. The study     is to be conducted at the Gugulethu Midwife Obstetric Unit (MOU) in Cape Town. There are     three phases of the study: Phase 1 is a cross-sectional evaluation of consecutive     HIV-infected pregnant women attending their first antenatal clinic visit (n=1600); Phase 2 is     an observational cohort that will follow women from Phase 1 who are eligible for ART (n=600)     from the second antenatal clinic visit until the first postpartum visit; Phase 3 is a     randomized trial of women from Phase 2 who are breastfeeding and will compare two different     service models for delivering ART to women after they delivery their babies (n=480). For     Phase 3, women who are taking ART will randomly be assigned to either (1) referral to receive     ART at the nearest adult clinic at 4-8 weeks after delivery (this is currently how all women     receive care in this setting) or (2) to continue to come to the antenatal clinic for ART     services until the end of breastfeeding. All women will received the standard local ART     services (with identical medications and medical treatment); they are different because some     women will stay longer in care at the antenatal clinic. All women participating in Phase 3     will be followed through at least 2 months after they deliver.   "
103339|NCT01933464|"     This study is designed to investigate whether topical application of a cromolyn sodium     solution is able to decrease the facial redness seen in patients with papulopustular rosacea.     Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to     have this effect. The study will enroll a total of 10 patients. 5 will randomly be assigned     to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive     the placebo solution. All participants will be instructed to apply their assigned solution     twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks after the     distribution of the solutions to measure the efficacy of their assigned solution.   "
103340|NCT01933451|"     The purpose of this study is to determine whether intraoperative restrictive fluid management     guided by pulse pressure variation produces a better effect on the postoperative lung     function, kidney function, inflammatory response and short-term outcome after esophagectomy     and reconstruction.   "
103341|NCT01933438|"     This study evaluates the ability of a supination and external rotation protocol to improve     the arm function and anatomy of children with birth related brachial plexus injuries.   "
103342|NCT01933425|"     To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no     neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with     pneumoperitoneum 12 mmHg.      Hypothesis:      Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to     skin surface, cm) compared to no neuromuscular blockade.   "
103343|NCT01933412|"     This is an open label clinical study designed to evaluate the safety and immunogenicity of     Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients.     The study hypothesis is that vaccination with Sci B Vac will achieve a higher seroprotection     rate and a higher anti-Hepatitis B surface antibody serum titer level than vaccination with     Engerix-B Dialysis patients will be categorized as naïve or previously vaccinated and     each group will be randomized to treatment. Naïve patients randomized to Sci-B-Vac Hepatitis     B vaccine will receive vaccination in three doses, 10 μg each, at 0, 1, and 6 months, or     Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months.     Previously vaccinated patients randomized to Sci-B-Vac Hepatitis B vaccine will receive     vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B     vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. All vaccines will be     administered via intra-muscular injection to the deltoid muscle. The study will consist of     three periods: a screening period of up to four weeks, a 24-week open-label treatment period,     and a 24-week safety follow-up period. The total expected duration of the study per subject     is 52 weeks as follows: Screening period: approximately 4 weeks; treatment period: 24 weeks;     and follow up period: 24 weeks. The primary endpoint is the by-vaccine difference in the     proportion of subjects attaining seroprotective immune response (anti-Hepatitis B surface     antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with either Sci-B-Vac or Engerix-B.     Secondary endpoints include anti-Hepatitis B surface antibody geometric mean concentrations     calculated for all subjects upon last active dose; the proportion of subjects with     anti-Hepatitis B surface antibody concentrations equal to or above 10 IU/mL for all subjects     at 12 weeks following the first vaccine dose; the by-treatment difference in serum titer     levels of anti-Hepatitis B surface antibodies at 12, 24 and 52 weeks following the first     vaccination. A by-vaccine comparison of adverse events will also be performed.   "
103344|NCT01933399|"     This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back     support) improves the short-term outcome of lower back pain. participants will receive     standard care (physical therapy, physician treatment), with one group also receiving an     extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has     been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis     is that the group wearing the inextensible LSO will have improved outcomes over the other two     groups (standard care or standard care plus the extensible LSO).   "
103345|NCT01933386|"     The primary objective of this study is to compare the SoundBite™ Hearing System to surgically     implanted BCD systems.   "
103346|NCT01933373|"     Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with     an increased pressure of the esophageal sphincter. This leads to impairment to swallow and     heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal     muscle layer extending over to the gastroesophageal junction is the treatment of choice for     achalasia. In order to prevent reflux of stomach content into the esophagus this has to be     combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped     around the esophagus (fundoplication). This procedure can be performed with the wrapped     fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter     introduces an angulation of the esophagus, which possibly may lead to an impairment of     swallowing ability and passage of food to the stomach. On the other hand, the Toupet     procedure may give a better control of reflux. The primary endpoint of the study is symptoms     of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH     measurements in the esophagus), radiological imaging of swallowing and quality of life.   "
103347|NCT01933360|"     Despite of the widespread use, and extensive studies, the optimal route of administration of     misoprostol before surgical abortion remains to be defined. Following administration of 400     mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours,     but the longer the interval the greater the risk or bleeding and expulsion of the uterine     contents before the surgical evacuation. Sublingual administration seems to give adequate     plasma concentration and cervical priming faster than oral or vaginal administration. This     may allow a shorter waiting time with maintained efficacy, less side effects and logistic     advantages.   "
103349|NCT01933334|"     PSSc-001 (LOTUSS)      This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and     tolerability study of pirfenidone in participants with systemic sclerosis−related     interstitial lung disease (SSc-ILD).   "
103351|NCT01933308|"     Chronic obstructive pulmonary disease (COPD) has a profound impact on the lives of     individuals who suffer from it. Participants with COPD are often caught in a downward spiral     that goes from chronic airflow limitation to invalidity and poor quality of life. Exercise     training is considered the key to successful pulmonary rehabilitation (PR) because it is     responsible for much of the benefits associated with this intervention. However, despite     current guidelines recommend high-intensity exercise training. the optimal exercise training     protocol for PR participants has yet to be determined. Aims: The main goal of the proposed     research project will be to determine the optimal exercise training protocol in PR. More     specifically, the objectives will be to compare the effects of continuous high-intensity     training (CT80), continuous training at the ventilatory threshold (CTVT), and interval     training (IT) on various PR program outcomes and to compare participant compliance to the     three training regimens. Methods: One hundred and twenty subjects will be recruited.     Participants who meet the eligibility criteria and accept to participate in the study will be     randomized to one of three groups: the CT80 group, the CTVT group, or the IT group. Session     duration will be adjusted such that the total amount of work performed per session will be     comparable between the three groups. Assessments will be made at baseline (week 0), at     program completion (week 12), and one year after program start (year 1). The primary outcome     measure will be short-term (12 weeks) change in exercise tolerance, as measured by the     endurance time to constant-load cycling. Secondary outcome measures will include: long-term     (1 year) change in exercise tolerance; short-term and long-term changes in functional status,     psychological status, cognition, and health-related quality of life; average participant     compliance to the target intensity throughout the 12-week program; and long-term adherence to     exercise recommendations. Relevance: The proposed research will inform clinicians and     scientists regarding which of the exercise training protocols currently used in PR is optimal     for COPD participants by examining their short-term and long-term impact on physiological,     functional, psychological, neuropsychological, behavioural and quality of life outcomes. For     COPD participants, our findings have the potential to improve the effectiveness of a key     intervention for the management of their disease.   "
103352|NCT01933295|"     Insomnia is recognized as the most prevalent and costly sleep disorders and is associated     with considerable morbidity including significantly reduced quality of life, impaired work     performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom     of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields     equivalent short-term efficacy and superior long-term durability to pharmacological treatment     of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with     menopause will be tested.   "
103353|NCT01933282|"     Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma   "
103354|NCT01933269|"     The purpose of this study is to assess a relatively new PET (Positron emission tomography)     radiotracer called FACBC in the assessment of head and neck cancer. FDG (Flourine     Deoxyglucose) is currently used for PET imaging, but has limitations in head and neck cancer.     These limitations include problems with specificity, high background uptake from normal     structures, difficulty delineating intracranial invasion, and the need to wait several weeks     after chemotherapy and radiation before imaging. As an amino acid radiotracer, rather than a     glucose radiotracer, FACBC overcomes some of these limitations. FACBC does not yet have FDA     (Food and Drug Administration) approval, but does show promise in initial work in patients     with prostate cancer and brain tumors. Dosimetry work on FACBC has been performed at Emory.      Our study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven     squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical     resection (ie, surgery without preceding chemotherapy or radiation). Patients must have     pre-surgical imaging, either with a contrast enhanced CT, FDG PET, or MRI. Patients who     consent to participate will receive one FACBC PET/CT of the neck, which will require a low     dose transmission CT of the neck, an intravenous injection of the radiotracer, and imaging     of the neck that will last up to 1 hour. Patients will have to lie still during the imaging     time. Total participation time including set up should be less than 90 minutes. Imaging     results will be analyzed and compared with conventional imaging as well as the surgical     pathology results   "
103355|NCT01933256|"     HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.      The purpose of this study is to investigate the safety and tolerability of repeat doses of     HIP2B in subjects with type 2 diabetes mellitus. The study will also assess whether islet     β-cell number and function will increase over time in response to repeat HIP2B injections.   "
103356|NCT01933243|"     Adolescents with anorexia nervosa frequently have associated anxiety, and standard     medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week     trial examining the safety, tolerability, and effectiveness of fish oil nutritional     supplements for anxiety in adolescents with anorexia nervosa.   "
103357|NCT01933230|"     The purpose of this study is to determine if cooling the neck of patients with ICH decreases     brain temperature. In addition, the investigators will determine if the device improves the     delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers     intracranial pressure (which is often times high in patients after ICH).   "
103358|NCT01933217|"     Traumatic Brain Injury (TBI) - methylphenidate treatment   "
103359|NCT01933204|"     The purpose of this study is to determine whether acupuncture is effective for relieving     perimenopausal symptoms.   "
103360|NCT01933191|"     A single bout of physical activity (treadmill)immediately prior to the dental examination     reduces anxiety in patients with dental phobia.   "
103361|NCT01933178|"     Conjunctivochalasis refers to loose redundant, non-edematous inferior conjunctiva that is     situated between the globe and lower eyelid, and usually it occurs bilaterally. It has been     reported to cause ocular discomfort, tear instability, alteration of tear spreading and     subsequently dry eye, which is a common condition that affects vision and quality of life in     patients. This condition has also been reported to be associated with aging and ocular     surface inflammation.      The assessment of conjunctivochalasis was traditionally based on silt lamp examination and     this may be cumbersome and highly subjective. Only recently, researchers have advocated the     use of imaging and more objective documentation by anterior segment optical coherence     tomography (AS-OCT), using Fourier-Domain RTVue-100 OCT. The AS-OCT is an imaging method that     documents the tear meniscus and prolapse of conjunctiva into the tear meniscus in a safe,     rapid and non-invasive way. Image analysis on the area of prolapsed conjunctiva can then be     used to ascertain the severity of conjunctivochalasis. We propose the use of HD-Cirrus AS-OCT     for the imaging of conjunctivochalasis, since this technique provides more magnified and     colored digital images, which helps to delineate different tissues and serves as a better     education tool for patients.      This current study aims to investigative the inter and intra examiner reproducibility of     imaging conjunctivochalasis using HD-Cirrus AS-OCT, using patients from the dry eye clinic     from the Singapore National Eye Centre. These patients will be asked to come to the centre     for imaging and have three scans of the same eye performed in one session by two trained     investigators consecutively. The resulting limits of repeatability will be very useful for us     to follow up patients who undergo surgical or diathermy treatment for conjunctivochalasis,     and for sample size calculation in the planning of interventional studies.   "
103395|NCT01932736|"     This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and     when the brain responds to pressure stimulations of the eardrum. The study requires 2 visits,     1 for screening to determine eligibility and 1 for the fMRI. This study will help to     understand how the middle ear system is controlled, which may have an impact on how people     with middle ear disease are treated.   "
103362|NCT01933165|"     Dry eye clinical research is limited to follow up of disease progression. While a large     catalogue of tests, such as corneal staining grading, tear break up time (TBUT) and     Schirmer's test, is available, objective assessments demonstrate poor to moderate     repeatability. Among these assessments, TBUT has the best repeatability while the Schirmer's     test shows good repeatability for more severe forms of the disease.1 As such, currently, most     research outcomes are based on subjective patient complaints rather than objective assessment     of the condition.      LipiView Ocular Surface Interferometer (LipiView) is a HSA-approved imaging device that has     the ability to assess optical interference pattern produced by light reflected off the tear     film in a safe and non-invasive manner.2 Software analysis of the image then measures the     tear LLT, which is used to objectively quantify the diagnosis of lipid-deficient dry eye.      This current study aims to investigative the inter and intra-examiner reproducibility of     measuring tear lipid layer thickness (LLT) with LipiView, which is used in our current     clinical setting. LipiView has not been evaluated on its reproducibility of measuring tear     lipid layer thickness. The study will also assess for correlation between the magnitude of     tear LLT and the inter and intra-examiner reproducibility of LipiView.      Once this method is found to be repeatable, this can be used in future clinical settings and     trials as an additional tool to investigate dry eye treatments.   "
103363|NCT01933152|"     Retrospective, non-interventional, observational multi-center field study. Patients diagnosed     with wet Age-related macular degeneration (wAMD) and having started treatment with     ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and,     if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011.     Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be     documented. For each patient, demographics, medical history, administered treatments, results     of ocular and visual assessments and other tests (where available) will be documented.   "
103364|NCT01933139|"     To determine whether the addition of audio-visual presentations to standard physician     interaction improves patient comprehension as it relates to the information provided during     the informed consent process in patients undergoing hysterectomy.   "
103365|NCT01933126|"     The study aims to examine the effect of intrauterine injection of HCG on pregnany rate in     women undergoing IVF treatment.   "
103366|NCT01933113|"     The study is a continuation of the clinical pilot study of lateral hypothalamic area (LHA)     deep brain stimulation (DBS) for severe obesity. Patients who met the enrollment criteria     underwent stereotactic placement of bilateral hypothalamic chronic stimulating electrodes.     The current trial will continue to monitor these subjects as well as objectively measure     metabolic rate (including energy expenditure, respiratory quotient, oxygen consumption, and     carbon dioxide production).   "
103367|NCT01933100|"     This study was conducted to investigate the effects of rice based-meal on functional     constipation in young Korean women.   "
103368|NCT01933087|"     Infections acquired by patients in hospitals are a major cause of illness and death     worldwide, and particularly so in hospitals with very limited resources. Simple hygiene     measures, including improved hand hygiene (particularly with increased use of alcohol-based     hand rub) by healthcare workers (HCWs) in physical contact with patients, are thought to be     amongst the most effective ways of reducing such infections. However, in most hospitals hand     hygiene is practiced poorly and improving hand hygiene behavior amongst hospital staff has     been found to be difficult.      This study aims to evaluate the impact of a multimodal intervention to improve hand hygiene     amongst health care workers in accordance with the WHO Guidelines on Hand Hygiene in Health     Care. The research design is a prospective stepped wedged trial using all in-patient wards in     a 1,000 bed hospital located in Northeast Thailand (Sappasitthiprasong hospital, Ubon     Ratchatani). A stepped wedge design is a type of cluster randomized controlled trial which is     appropriate when there are prior reasons to believe the intervention will be beneficial (as     opposed to equipoise) and when it is impractical to deliver the intervention to all study     units simultaneously. Both conditions hold here. The intervention will include educational     visits to healthcare workers, improved reminders in the workplace, audit and feedback and     social marketing with the aim of inducing behavioural and cultural change in relation to hand     hygiene. The intervention will be delivered by the infection control team and the infection     control ward nurses (ICWNs) who will receive additional training. The primary outcome will be     directly observed hand hygiene compliance. Secondary outcomes will include incidence density     of hospital-associated bloodstream and urinary tract infections with specified multiply     antibiotic resistant bacteria, incidence density of hospital-associated bloodstream and     urinary tract infections with non-multiply antibiotic resistant bacteria, total patient     mortality rates, and ward-based consumption of alcohol hand rub and soap (a proxy for hand     hygiene compliance).      Results from this study will be immediately generalisable to other resource-constrained     hospitals in Thailand. The research will also have much wider international significance as     there have been very few methodologically sound evaluations of the impact of hand hygiene     interventions in hospitals. Moreover, the findings will provide essential information for     subsequent work on economic evaluations of infection control interventions to determine under     what circumstances such interventions are likely to be cost-effective.   "
103369|NCT01933074|"     The purpose of this study is to gain a better understanding of what causes urinary urgency in     women by asking about different symptoms and measuring biomarker levels in their urine.     Understanding the underlying causes of urinary urgency will allow us to develop treatment     options to better take care of women with urinary urgency.   "
103370|NCT01933061|"     A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with     Abraxane administered weekly with respect to overall survival, objective tumor response rate     and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant     melanoma.   "
103371|NCT01933048|"     The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity     of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with     healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group     self-administration of LAIV.   "
103372|NCT01933035|"     To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP)     from hypo-proliferative causes of thrombocytopenia.      To develop the clinical potential of the extended platelet parameters as they pertain to     distinguishing different causes of thrombocytopenia from one another.      To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might     distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated     destruction of platelets.   "
103373|NCT01933022|"     The purpose of this study is to investigate the effect of the study medication (Eligard®) on     cancer markers (in the blood) of prostate cancer.   "
103374|NCT01933009|"     GnRH administration during the luteal phase was found to significantly increase pregnancy     rates in women undergoing fresh-cycle IVF cycles.      We aim to investigate the effect of GnRH administration during the luteal phase in women     undergoing frozen-thawed IVF cycles.   "
103761|NCT01927965|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) and the     dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™     recommended for future phase 2 protocol   "
103375|NCT01932996|"     The goal of this research study is to enhance smoking cessation rates for homeless smokers by     testing effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse     treatment with smoking cessation. We will utilize a 3-group randomized design to test study     hypotheses. The three study conditions are 1) Integrated Intensive Smoking plus Alcohol     intervention using cognitive behavioral therapy (CBT), CBT—(IS+A); 2) Intensive Smoking     Intervention using CBT—(IS); or 3) Usual Care (brief smoking cessation and brief alcohol     counseling both based on the United States Public Health Service's Guidelines)—(UC). All     participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge.     Counseling will follow the protocol used in a recent study of alcohol dependent smokers and     will include weekly individual sessions for 3 months followed by monthly booster group     sessions for 3 months. As a strategy to integrate proposed project with existing programs at     the shelters, all group counseling sessions will be co-facilitated by trained study staff and     trained homeless shelter staff. All 3 study conditions will have equal number of study     contacts. Study staff will make retention contacts with participants in the community during     weeks that do not have study visits scheduled. Primary smoking outcome is cotinine-verified     7-day smoking abstinence at week 52 follow-up while secondary outcome is prolonged smoking     abstinence at weeks 12, 24, and 52. Secondary alcohol outcome will be self-reported     continuous alcohol abstinence for 90 days at week 52. Recruitment and retention will be     enhanced by use of debit cards, bus passes, other non-monetary incentives, attractive     intervention materials, collaboration with homeless shelters, and advice from a Community     Advisory Board. Participants will be enrolled from homeless shelters and facilities in the     7-county greater Minneapolis/St. Paul metro area. Our power calculation indicates that a     sample size of 215 per study condition is needed to detect proposed treatment effects.   "
103376|NCT01932983|"     The study examines the clinical application of TOF (train of four test) used by     anesthesiologists and neurophysiologists during instrumented spine procedures, as well as     certain associated parameters. 'Train of four' test is a test routinely used during the     surgery, which is performed by stimulation of peripheral nerve with purpose to determine the     degree of muscle relaxation by interpretation of muscle response. During spine surgery, it is     helpful for the surgeon to have a patient's muscles as relaxed as possible with the least     amount of tone, especially when exposing. Anesthesiologists achieve this level of relaxation     by giving a neuromuscular blocking agent. If medication given to do this has not fully left     their system by the time the surgeon needs to start putting in the screws and rods, then the     intraoperative monitoring can not be adequately performed. If the muscles are too relaxed,     then free run EMG and screw stimulation, two monitoring methods used, will not be analyzed     correctly and the surgery may be adversely affected. This study compares the results of the     'train of four' test performed by neurophysiologists and anesthesiologists. Additionally, it     looks at the differences, if any, in comparing stimulation of the foot nerve (tibial n.) or     hand nerve (ulnar n.) Performing the TOF (train of four test) in the lower extremity can be     relevant for many reasons. Train of four tests can show the presence of four twitches in the     arms but the legs may not fully recovered from muscle relaxant given by anesthesia. Also,     train of four test which uses subjective method of interpretation by anesthesiologists may     present different results compared than objective quantitative method of train of four test     interpretation. Ultimately, the goal of this study is to show the importance of 'TOF' testing     in ensuring that any identifiable preventable intraoperative surgical complication is     appropriately identified.   "
103377|NCT01932970|"     This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on     serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG     416).   "
103378|NCT01932957|"     Standard management for patients with ruptured ectopic pregnancies at our institution is     treatment by laparotomy. This trail will investigate the feasibility of treatment with     laparoscopy and will look at outcomes such as hospital stay and pain experienced      The hypothesis is that laparoscopy is a feasible treatment option associated with shorter     hospital stay and less pain   "
103379|NCT01932944|"     To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System (System)     interstitial glucose results against venous glucose reference and capillary fingerstick using     the Consensus Error Grid over the wear duration. During the course of the wear duration, the     subject is required to be testing fingerstick glucose measurement at least 8 times a day for     capillary reference glucose measurements and three in-clinic visits of maximum 10 hours each     for venous reference glucose measurements. With every reference measurement, the subject or     study staff will perform a measurement on the System.   "
103380|NCT01932931|"     In recent years it has become evident that some types of antidepressants are associated both     with an increased risk of falling and decreased bone mineral density. These factors     predispose patients for serious fractures such as hip fractures with substantial morbidity     and mortality. The specific mechanisms involved in this negative impact on bone and postural     control have not been fully elucidated. It is well known that Vitamin D plays an important     role for bone health as well as muscle function and thus indirectly postural control.     Furthermore, vitamin D deficiency has been observed among depressed patients. To our     knowledge no study has investigated the involvement of Vitamin D in relation to the increased     risk of fractures associated with antidepressants. Therefore, this project will investigate     the underlying mechanisms leading to skeletal impairment and musculoskeletal symptoms in     patients receiving different types of antidepressants. Moreover, the effect of vitamin D     supplementation will be investigated among patients taking these antidepressants.      150 subjects will participate in this study: 50 of which is diagnosed with depression and     receive Citalopram (SSRIs); 50 depressed subjects receiving Mirtazapine(NaSRI); and 50     controls. Through randomisation half of the subjects in each group will receive daily Vitamin     D supplementation for a period of one year. Through this period all 150 subjects will be     followed through different measurements including bone density, muscle function and balance,     nociception, quality of life and depression severity.      It is expected that results from this study will provide increasing awareness and knowledge     of the side effect profile of antidepressants on bone metabolism. This may prompt clinicians     to screen patients at high risk of drug-induced osteopenia or osteoporosis and accordingly     provide treatment, which may reduce the incidence of potentially avoidable fractures.     Moreover, some types of antidepressants may show to produce a minimal or even no effect on     bone turnover, and should be considered as first line treatment in the group of patients at     risk of fractures.   "
103381|NCT01932918|"     Postoperative pain caused by surgery-associated tissue injury is a major concern for all the     clinical practitioners. Because it affects multiple systems and induces physiological,     immunological and psychological changes. Previous literature showed surgical injury induces a     systemic inflammatory metabolic-endocrine response that is proportional to the severity of     the surgical stress. In surgeries such as liver transplantation, the patients suffer not only     from postoperative pain but also an additional oxidative stress caused by ischemia     reperfusion. Previous report have proved that an adequate postoperative pain control improves     the recovery and reduces the inflammatory cascade by suppression of physiological and     psychological stresses. However, the effect of postoperative pain management on ischemia     reperfusion injury is unclear so far. In this three year study, we plan to continue our     previous study to test the following two hypothesis: (1) postoperative pain exacerbate remote     organ injury caused by ischemia reperfusion, (2) the interaction of different antinociceptive     modalities on ischemia reperfusion injury.   "
103394|NCT01932749|"     The aim of this study is to investigate the effect of repetitive TMS in reduction of     depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical     trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to     receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety     symptoms and quality of life will be assessed before the treatment (pre test) during the     treatment (10th session), and after the treatment (post test). QEEG apply before and after     rTMS in all subjects.   "
103762|NCT01927952|"     The purpose of this research project is to compare three different methods for fixation of     hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3)     Stryker Smart-Toe implant.   "
103382|NCT01932905|"     Pain affects up to 30% of the general population. In particular, neuropathic pain (NeP) is     caused by lesion or desease affecting peripheral or central somatosensory pathways and     affects 7% of the adult population. Despite the availability of evidence based     pharmacological and surgical treatment for NeP, about 50% of patients remais symptomatic     despite best medical treatment. Some neuropathic pain syndromes are specially refractory. In     particular, central NeP is caused by disease or lesion to central structures involves in     somatosensory integration of nociceptive information is non-responsive to drugs usually     employed in other NeP syndromes. Classical neuromodulatory techniques such as conventional     repetitive Transcranial Magnetic Stimulation aiming at the motor of prefrontal cortices are     ineffective to relieve pain in this population. Recently new technology advances have made     possible non-invasive stimulation of deeper cortical targets. Some of them are activelly     involved in the integration of the perception of pain, such as the anterior cingulate cortex     or the posterior insula. The aim this study is to treat 90 patients with central pain (post     stroke pain, spinal cord lesions after trauma or demyelinizating diseases) under best medical     pharmacological treatment in three different conditions: AAC (n= 30 with the H-Coil),     Superior Posterior Insula (SPI) n=30 cooled double cone coil double cool coil, and     sham(n=30). Each patients will undergo daily stimulation for a week, then weekly stimulations     for 3 months (total of 17 sessions). The main study outcome is pain relief at the last     stimulation week (visual-analogic scale). Secondary end-points are changes in the McGill Pain     Questionnaire, Neuropathic Pain Symptom Inventory, DN4 questionnaire, SF -36, brief pain     inventory and cognitive assessment including the trail making test A and B, Strrop color     interference test, and subscalles from the CERAD. All patients will undergo quantitative     sensory test and measurements of cortical excitability over M1 before and after to treatment.   "
103383|NCT01932892|"     This study will quantify motion occurring at the socket interface of transhumeral prosthesis     users during common tasks. Participants in the study will use a body powered prosthesis with     a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded     into the socket wall will record the amount of movement between the residual limb and socket     of the prosthesis. Participants will complete range of motion and functional tasks. The range     of motion tasks include shoulder flexion, abduction and rotation as well as elbow flexion.     The functional tasks include bilateral lift of weighted basket, unilateral lift of weighted     handle, box and blocks test, walk and carry a gallon of milk, and folding a towel. It is     expected that the more weight at the terminal device the more rotation at the interface, as     well as more slip between residual limb and device. It is also expected that the soft tissues     of the residual limb can be modeled as a nonlinear spring and the amount of movement at the     interface can be predicted based off the force in the system.   "
103384|NCT01932879|"     Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts     can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid     class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation,     and this may be the mechanism by which body fatness is influenced by anthocyanin intake.     Well-controlled studies in humans are lacking.   "
103385|NCT01932866|"     The purpose of this randomized, controlled study is to evaluate whether the knowledge of a     personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle     change program in prediabetic patients. The intervention group will receive diabetes risk     score results at the beginning of the twelve weeks, and the control group will not receive     these results. Both groups will review their baseline and 12-week diabetes risk score results     at the conclusion of the program and will be followed for an additional twelve weeks.     Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c,     fasting blood glucose, cholesterol, and diabetes risk score will be compared between the     groups.   "
103386|NCT01932853|"     The aim of this study is to assess whether patients receiving current recommendations of an     adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months     compared to those who do not get it, as well as assess whether patients receiving a dose     greater obtain more benefit.   "
103387|NCT01932840|"     Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The     Canadian government has recently allowed plant sterols to be added to certain foods and has     also approved a disease risk reduction claim to be allowed on products containing plant     sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.      The objective of this study was to evaluate the attitudes and understanding of different     types of plant sterol claims on food labels   "
103388|NCT01932827|"     Oat fibre consumption has been shown to lower blood cholesterol, which is advantageous for     heart health. Oat and fibre claims on food labels should help people find heart healthy food     choices; however consumer attitudes and understanding of such claims are unknown.      The objective of this study was to evaluate the attitudes and understanding to different     types of permitted oat fibre claims.   "
103389|NCT01932814|"     The purpose of the present study is to determine whether administration of aminoglycosides in     septic critically ill patient is a risk factor for acute kidney injury   "
103390|NCT01932801|"     The goal of this study is to test the efficacy of extended-release naltrexone and harm     reduction counseling in reducing alcohol-related harm among homeless people with alcohol     dependence.   "
103391|NCT01932788|"     The purpose of this study is to give all mothers the best chance for a healthy pregnancy     through vitamin D supplementation. We will study women of diverse racial/ethnic backgrounds     who will receive either the current vitamin D standard of 400 IU/day (in the prenatal     vitamin) or 4000 IU/day (dose found in previous pregnancy studies to achieve vitamin D     sufficiency).      This research is sponsored by the W.K. Kellogg Foundation and the Medical University of South     Carolina. The purpose of this study is to examine the effectiveness and infection-fighting     properties of the body in relationship to vitamin D levels. This study is being done at the     Medical University of South Carolina (MUSC) clinics, and will involve approximately 450     volunteers.   "
103392|NCT01932775|"     Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic     management in non-critically ill patients with type 2 diabetes at general wards.   "
103393|NCT01932762|"     This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of     grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or     ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype     (GT) 2, 4, 5, and 6 hepatitis C infection.      In Part A there is no randomization or stratification; all GT2 participants will be assigned     to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants     with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with     stratification by genotype.   "
104193|NCT01922310|"     The overarching aim of this study is to examine the process of organ donation decision-making     and to determine whether changes in requesting practices change rates of consent for     donation, and other family-based outcomes.   "
103397|NCT01932710|"     Patients with leukemia often have low white blood cell counts after chemotherapy, which puts     them at greater risk of infection. The standard of care for preventing infections is to give     these patients antibiotic, antifungal, and antiviral drugs during the time that white blood     cell counts are low. However, many patients still develop infections during chemotherapy.     Radiated white blood cell transfusions are a standard treatment once a patient develops a     severe infection.      The goal of this clinical research study is to learn if giving white blood cell transfusions     that are not radiated early in chemotherapy might delay or prevent infections in patients     with leukemia. Researchers also want to learn more about the type and severity of any     infections that do occur.   "
103398|NCT01932697|"     This phase II trial studies how well radiation therapy and docetaxel work in treating     patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses     high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. Giving radiation therapy with     docetaxel my kill more tumor cells.   "
103399|NCT01932684|"     Objective: To evaluate the effects of technical-Breath Stacking (BS) and incentive spirometry     (IS) on the volume of the chest immediately after and within thirty minutes after the     techniques in patients with Parkinson's disease (PD). Methods: This is a study of cross-over.     The study investigated 14 patients with mild to moderate PD. The subjects performed the     technique Breath-Stacking, incentive spirometry volume and participated in a phase control     according to randomization. The volunteers were evaluated by opto-electronic plethysmography     in four stages: before, immediately after fifteen and thirty minutes after the completion of     the techniques. The investigators used a repeated measures ANOVA with post-hoc Tukey test for     parametric variables, and the Friedman test with post-hoc Dunns for nonparametric variables.     The level of significance was set at 5%, p <0.05.   "
103400|NCT01932671|"     After having had a first cardiovascular event, there is a considerable risk of developing a     subsequent event. Only recently, a risk prediction model was developed for this group of     patients. Imaging techniques such as the coronary artery calcium score and contrast-enhanced     computed tomography (CT) of the coronary and carotid arteries could be able to add improve     this model. Imaging may further improve the prediction of future manifestations of arterial     disease and personalize disease monitoring and treatment.   "
103401|NCT01932658|"     The purpose of this study is to evaluate the safety and potential clinical benefit of     lymphoablation followed by autologous HSCT rescue in therapy refractory Crohn's disease   "
103402|NCT01932645|"     Prostatitis is so widespread a disease that affects people from youths to seniors, with     approximately a third experiencing a remission of symptoms over a year follow-up. Although     the etiology of prostatitis is still not clear, it is mainly thought to be due to infection     of bacteria or other microorganisms. Up to now, there is still no research being done on the     microbiome (bacterial species) of the prostate. The objective of this study is to look at the     etiology of chronic prostatitis(bacteria or non-bacteria prostatitis), mainly focusing on the     effect of bacteria in the prostate.   "
103403|NCT01932632|"     The purpose of this experiment is to test the effect of medication minimization on mortality     and hospitalization in long-term care residents.   "
103404|NCT01932619|"     Breast milk is best food for neonates and preterm infants. However many handling would be     done if direct breastfeeding is not feasible, and it may result in nutrients change in human     milk. We investigate the influence of storage in different containers and different thawing     or heating methods on human milk nutrients.   "
103405|NCT01932606|"     Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that     has no proven effective treatment. This study assessed the effects of acute nitrite     administration on resting and exercise hemodynamics in patients with HFpEF.   "
103406|NCT01932593|"     There is no cure for Multiple Sclerosis (MS) and we are always looking at new ways to stop     the disease process and/or promote repair.      We hypothesise that autologous bone marrow cellular therapy in chronic MS offers durable     benefit.      The purpose of this study is to test the safety of repeated bone marrow stem cell infusion in     patients with MS. We want to find out what effects, good and/or bad, it has on you and your     disability.      You have previously participated in a safety study of bone marrow stem cell infusion in     patients with MS. The results raised the possibility of some early partial repair;     measurements of the speed of neurological impulses in the brain and spinal cord improved. The     current study seeks to determine whether those benefits have persisted and whether they can     be repeated or enhanced by repeating the procedure.   "
103407|NCT01932580|"     Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy     before and after surgery. The chemotherapy regimen used in our institution, called DCF     (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia     relief. however, it is toxic, causing approximately half of patients severe inflammation of     the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting and     diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at least     equally active, but less toxic.      Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking     upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less     than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to     proceed with the next trial, a randomized comparison of DCF and FLOT   "
103408|NCT01932567|"     To compare the effect of different airway clearance techniques on lung ventilation by     electrical impedance tomography.   "
103409|NCT01932554|"     The purpose of this study is to determine whether giving abciximab (ReoPro) to children with     sickle cell disease who are hospitalized for acute pain crisis will improve their pain and     shorten the time spent in the hospital, when compared with standard supportive care.   "
135465|NCT01511679|"     This is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and     shorter-term effect of adolescent alcohol use on the developing brain.   "
103410|NCT01932541|"     This study is an 8-week open-label trial testing Lurasidone (Latuda®) as a treatment for     mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum disorders.     We hypothesize that Lurasidone will be safe, tolerable, and effective in improving the core     symptoms of bipolar disorders in children and adolescents ages 6-17.   "
103412|NCT01932515|"     The trial is in three stages and will translate and validate screening and assessment     instruments for use with deaf children.      The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for     use with deaf children. This will involve choosing the most promising screening instrument     (SRS-2) based on the systematic review and the expertise of a review panel, which contains     experts and public and patient involvement (PPI). This phase of the study seeks a wide range     of user (parents/ carers and young people) views and experiences about the symptomatology and     presentation of deaf children with autism, comparing this to hearing children with autism,     and deaf children without autism.      The second stage is to ensure that the newly modified instruments are accessible to deaf     children and deaf parents by making any necessary translations from English into British Sign     Language. This involves a strict translation and back translation methodology with     reiterations until successful translation is achieved.      For stage three in order to ensure that the new questionnaires are successfully identifying     children and young people with Autism Spectrum Disorder, the modified instrument will be     validated using a 'gold standard'. The current 'gold standard' for the mental health     screening of Deaf children is a clinical interview administered by experienced senior     multidisciplinary deaf child mental health clinicians.   "
103413|NCT01932502|"     The purpose of the study is to examine the clinical safety, tolerability, and efficacy of     clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with     refractory epilepsy.   "
103414|NCT01932489|"     Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential     for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by     examining the feasibility and turnaround time of performing and obtaining data from a few key     molecular assays.      Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be     enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen     assay will be performed using DNA sequencing.      Results will be discussed during a molecular screening tumor board.   "
103415|NCT01932476|"     The purpose of this study is to determine whether the immune response causing celiac disease     is related to the autoimmune response causing type-1 diabetes.   "
103416|NCT01932463|"     A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR     Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor   "
103417|NCT01932450|"     A randomized, open-label single-center study investigates the efficacy and safety of     bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on     blood pressure and disease progression control in autosomal dominant polycystic kidney     disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed     with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency     ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic     blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure     monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and     ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure     tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys     and renal function, will be assessed at 12 months of follow-up. The safety variables will be     assessed at every visit of follow-up.   "
103418|NCT01932437|"     This study is to evaluate the safety and local tolerability of single intramuscular (IM)     doses of ETI-204; to evaluate the pharmacokinetics (PK) of a single IM dose of ETI-204; and     to evaluate the immunogenicity of a single IM dose of ETI-204.   "
103419|NCT01932424|"     During major spinal surgery evoked potential monitoring is performed to detect spinal cord     damage. Intra-venous anaesthesia is the preferred anaesthetic technique because volatile     anaesthetic agents supress the evoked potentials. Total Intra-Venous Anaesthesia (TIVA) with     propofol is commonly administered as a Target Controlled Infusion (TCI). The TCI is an     automated drug delivery system which administers propofol to achieve a desired blood     concentration, based on an in built pharmaco-kinetic data (TCI model) derived from previous     studies. The TCI model also provides a real time predicted blood concentration to facilitate     the anaesthetist to adjust the target concentration of propofol.      The TCI algorithm is based on pharmaco-kinetic data derived from previous studies in a     relatively small number of patients, by a best fit relationship between blood levels,     infusion rates and other factors (such as age and weight). Several factors make it possible     for a wide discrepancy between the predicted and the true blood concentrations. This     difference can be higher in children compared to adults. Also blood loss and administration     of large volumes of intravenous fluids can affect the blood concentrations. This study aims     to identify the difference between the predicted and true blood concentrations by using     Pelorus 1500, a bedside blood propofol measurement device, in children undergoing major     spinal surgery under TIVA.   "
103420|NCT01932411|"     Identify factors that contribute to perioperative morbidity and mortality in patients     undergoing cardiac surgery that involves cardiopulmonary bypass.      Identify factors that affect perioperative morbidity and mortality in patients undergoing     cardiac surgery.   "
103421|NCT01932398|"     Investigate the hypothesis that children with ADHD have difficulty with the allocation of     visio-spatial attention related to an inability to control posterior alpha brain     oscillations. A paradigm will be used in which the aim is to address covert attention as     similar recent studies did in adults with ADHD.   "
103422|NCT01932385|"     Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in     China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS     and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class     A patients, but the result for Child-Pugh class B patients is unclear.   "
124605|NCT01654692|"     This study is designed to assess the safety and efficacy of a combination of ipilimumab and     fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma.   "
103423|NCT01932372|"     The objective of this Surveillance is to verify the following subject matters concerning     Tofacitinib (Xeljanz) under general practice.      1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy     2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy      Occurrences of malignant tumors and serious infections will be compared with a control group.   "
103427|NCT01932320|"     The purpose of this study is to compare the rate and extent of absorption of a single dose of     two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part     1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of     absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and to     explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and extent     of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 3).   "
103428|NCT01932307|"     There are currently no standardized programs addressing the well-documented neck pain in     surgeons as a result of non-ergonomic positioning and the use of microsurgical equipment. The     primary goal of this study is to introduce a brief neck strengthening exercise program to     optimize surgeons' neck health. Instructional videos outlining the program along with surveys     designed to assess attitude towards neck health will be distributed to first year general     surgery residents at the University of British Columbia (UBC) through their required online     curriculum webpage. A followup survey will be administered 10 weeks later to determine     efficacy of the program through self-reported adherence and changes in attitude towards neck     health.   "
103429|NCT01932294|"     Medamacs is a prospective, observational study of ambulatory patients with advanced heart     failure. The study enrolls patients who have not yet received a Left Ventricular Assist     Device (LVAD) but who receive their care at a hospital with a Joint Commission certified     mechanical circulatory support program.      Medamacs is funded through the Interagency for Mechanically Assisted Circulatory Support     (INTERMACS) NHLBI Contract.   "
103430|NCT01932281|"     The purpose of this study is to examine whether supplementation with SierraSil can improve     anaerobic power and reduce muscle fatigue in a group of well-trained athletes.      A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset     muscle soreness.   "
103431|NCT01932268|"     The purpose of this study is to examine the colchicine concentration before and after the     administration of rifampicin.   "
103432|NCT01932255|"     Even at centers with very large experience, the risk of cerebrospinal fluid (CSF) leakage in     surgery for microvascular decompression is reported up to 3%.      Prevention of leakage is important since meningitis may follow. Also, leakage usually means     longer hospital stay and increased cost.      In case of detected leakage extra sutures may be applied, placement of a lumbar drain may be     considered or a revision and improved closure may be attempted. With leakage in the     subcutaneous tissue, but not through the skin, a local accumulation causing local symptoms     may also occur. In addition to being burdensome and being associated with longer hospital     stays with possible revision surgery, such complications are also very costly. The best way     to reduce cost and burden, and to improve patient care, is to prevent CSF leakage.      The aim of this study is to determine if prophylactic lumbar tap is beneficial for prevention     of cerebrospinal fluid leakage following microvascular decompression, by comparison of     surgical approaches in 3 geographical areas in the Scandinavian health system.      Hypothesis: There is no difference in cerebrospinal fluid leakage between the group subject     to prophylactic spinal tap versus the group without prophylactic spinal tap.   "
103433|NCT01932242|"     To evaluate the safety and tolerability of repeat administration (two doses) of intravenous     (IV). To evaluate the pharmacokinetics and immunogenicity of ETI-204 after repeat IV     administration.   "
103434|NCT01932229|"     Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal     growth factor receptor) gene, which have disease progression after treatment with an EGFR     inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with     chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment.     Blood and exhaled breath samples will be collected for investigations aiming to identify     factors that predict response to afatinib.   "
103435|NCT01932216|"     Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci     Single Site Instruments™ to multi-port (four ports) laparoscopy   "
103436|NCT01932203|"     There may be a difference in efficacy of cilostazol and aspirin on progression of white     matter changes in cerebal small vessel disease.   "
103461|NCT01931878|"     The purpose of this research study is to compare the safety and effectiveness of local     injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a     medical condition called Restless Leg Syndrome. This study has a double blind cross over     design. Cross over means that you will have two sets of injections. The first set of     injections can be either Xeomin or placebo. The order of injection will be reversed at the     three month point following the first injection. Double blind means neither the investigators     nor you know which one of the two (Xeomin or placebo) you received.   "
103462|NCT01931865|"     The purpose of this research study is to investigate the safety and effectiveness of     botulinum toxin A (Xeomin) ® injections in patients who suffer from focal pain in areas of     radiation and/or surgery as a result of cancer treatment. Our hypothesis is that injection of     incobotulinum toxin A into an area of local pain, at or around the area of a     post-surgical/post radiation scar, relieves the focal cancer pain.   "
103463|NCT01931852|"     The broad, long-term objective is to improve outcomes by optimizing healthcare delivery     processes for patients with detectable to elevated serum troponin. This clinical trial     involving emergency department (ED) patients with intermediate to high-risk chest pain and     detectable to minimally elevated serum troponin within 6 hours of evaluation.   "
103464|NCT01931839|"     The purpose of this study is to evaluate the efficacy and safety of long-term treatment with     lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.   "
103465|NCT01931826|"     Upper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality in     patients with portal hypertension secondary to schistosomiasis mansoni. Taking into account     the endemic nature of schistosomiasis mansoni in our region and the high morbidity and     mortality directly associated with rupture of esophageal varices and UGIB in affected     patients, we conducted a prospective randomized trial in patients with schistosomiasis and a     history of bleeding esophageal varices. Its purpose was to assess the efficacy of endoscopic     treatment alone compared with the efficacy of sclerotherapy preceded by a surgical treatment:     Esophagogastric devascularization with splenectomy (EGDS).   "
106098|NCT01897311|"     The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve     stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.   "
103437|NCT01932190|"     The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients     with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter     prospective randomized open-label trial to compare two strategies in ICU patients     (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as     RIFLE F classification. These patients will be randomly allocated to one of the following     strategies:        1. an early strategy where RRT is started immediately when a RIFLE F status is documented        2. a delayed strategy where RRT (in patients who also present RIFLE F renal failure) is          started only in case of occurrence of one or more of the following events (Alert          Criteria): oliguria or anuria lasting for more than 72 hours after randomization, serum          urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum          potassium concentration > 5.5 mmol /L that persists despite well-conducted medical          treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial          pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context          of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value,          acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min          in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or          noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.      The primary endpoint is overall survival, measured from the date of randomization to the date     of death, regardless of the cause. The minimum duration of each patient's follow-up will be     60 days.   "
103438|NCT01932177|"     EVESOR multiparameter phase I trial aims at determining the safety of different doses and     dosing schedules of everolimus in combination with sorafenib as well as the recommended doses     & dosing schedules for phase 2 trials in adult patients with advanced solid tumors.   "
103439|NCT01932164|"     The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar     bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous     dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®)     through prospective qualitative and quantitative analysis of bone neoformation.   "
103440|NCT01932151|"     Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced     cirrhosis characterized by marked renal failure and is associated with a very poor prognosis.     Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously.     It has been demonstrated that vasoconstrictor agents plus albumin are effective in the     reversal of the renal failure. A large number of studies have shown that terlipressin     improves renal function in patients with type 1 HRS; treatment is effective in 50-75% of     patients approximately. Currently there are no specific studies about the treatment of type-1     HRS with ongoing infections.   "
103441|NCT01932138|"     The purpose of this study is to determine the effectiveness, cost-effectiveness, feasibility     and acceptability of an enhanced community health worker (CHW) intervention and outreach     system to improve antenatal care and PMTCT uptake and retention, and to decrease     mother-to-child HIV transmission.   "
103442|NCT01932125|"     This multicenter prospective observational study will evaluate the safety and efficacy of     Avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic     epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Data will be     collected from eligible patients until death, withdrawal of consent, loss to follow-up, or     study closure.   "
103443|NCT01932112|"     The investigators studied the effects of adenosine on the reconnection rate after successful     pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant     atrial fibrillation   "
103444|NCT01932099|"     A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve     system. This is for people with severe aortic stenosis who are not well enough to undergo a     surgical repair. The delivery of this device is done via the femoral artery.   "
103445|NCT01932086|"     This study was an open, 5-treatment, 5-sequence, 5-day cross-over randomized design clinical     trial. The present study was carried out to compare the effects of white rice, brown rice,     and black rice on postprandial glucose and lipid profiles in healthy human subjects, using a     white bread as a positive control.   "
103446|NCT01932073|"     Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of     light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment     modality based on the photochemical effect of light on tissues, which modulates various     metabolic processes.      LLLT has been used for a wide range of conditions, in particular in dermatology, to promote     wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to     assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation     dermatitis), a very common and distressing side effect of cancer treatment.   "
103447|NCT01932060|"     Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to     initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to     maintain adequate uterine tone after delivery. The study investigators aim to compare two     different infusion rates of oxytocin to assess the optimal infusion regimen for reducing     blood loss in women undergoing elective Cesarean delivery.   "
103448|NCT01932047|"     ■ Unmet medical needs for Refractory cancer Conquest      - Many advanced cancers are still detected Despite remarkable technological advances for the     early diagnosis of cancer in the field last 20 years.      In the type of progressive carcinoma is very high malignancy despite a variety of therapeutic     target treatment for refractory cancer.      The refractory cancer patients who main focus of this research defined as the adult solid     tumor patients who have failed standard therapy according to the criteria      NCCN / ASCO (American Society of imsangam) / KCSG (Study Group for chemotherapy).      The survival rate of refractory cancer patients are estimated to be 30-40% of the total     patients with metastatic solid tumors and these refractory cancers are      difficult to deal with or control to conventional treatment so shows almost close to 100%     mortality.      Therefore the new development of therapies for conquer of refractory cancer are urgently     required.      ■ Preclinical translational research Unmet Needs of Bio-new drug development for conquer of     refractory cancer      - The stage of preclinical translational research (Translational Research) connects between     the early stages of development and clinical trials in the stage drug development.      The establishment of foundation based on the translational research is very necessary and     this must have proven ability to treat refractory cancer.      The most anti-cancer drugs developed by existing preclinical testing method actually does not     show a remarkable effect in many cases in the clinical trials,      even if showed a remarkable inhibitory cancer effect in animal testing.      The exact molecular diagnosis to treat targets and paradigm for the development of new drugs     at the same time requires for target treatment.      The tailored cell lines by patients and the proven technology by animal models and unmet need     for preclinical translational research is increasing   "
103449|NCT01932034|"     We will compare the percentage of patients having therapeutic vancomycin serum concentrations     after current standard dosing, after dosing with our software. We will also include     therapeutic outcomes and costs in the analysis.   "
103450|NCT01932021|"     The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It     occurs in patients older than 60 years followed for hypertension. Clinical diagnosis requires     eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia, cholesterol     crystal emboli, vasculitis associated with hepatitis C, myeloproliferative disorders and     ulcers associated with the Hydrea ® outlet.      There is no treatment of the ulcer because conventional treatments are ineffective. The pain     has subsided by analgesics III. Other treatments are not effective outside skin grafts to be     repeated because they necrotic regularly. In a prospective uncontrolled study, 11 patients     healed through autohemotherapy.      Ineffective treatment of this painful condition and efficiency of these cells to the damaged     tissue, due to the secretion of many bioactive molecules, led us to propose subcutaneous     injections of autologous fat to change the wound bed, promote healing and eliminate pain.     This treatment should help to avoid long-term hospitalization (about 15 days) that can lead     to physical and psychological degradation of these elderly patients.      The investigators propose an open clinical study of 10 patients with a single-center     recruitment (CHU Caen). The study took place over a period of 18 months with a 12-month     recruitment and follow-up of 6 months for each patient.      The purpose of this study was to evaluate the one hand, tolerance, in terms of pain and side     effects, and, on the other hand, the effectiveness of this therapeutic approach, in terms of     healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3     months wound. The measure of effectiveness will also focus on the changing appearance of the     wound, including the relative areas of fibrin, necrosis and budding. These efficiency     measures (area ratio) will be done through a computer program (CANVAS ®) on photographs taken     at each assessment time.      Eventually, if this study was to demonstrate the effectiveness of this treatment lipofilling,     it would be possible to perform a multicenter study on a large number of patients to     demonstrate the effectiveness, in terms of wound healing that the pain it causes and offer a     shorter hospital stay, and in parallel, this approach should improve the pathophysiology of     ulceration (translational research).   "
103451|NCT01932008|"     The purposes of this study are: (1) to compare the body composition, physical activity,     physical function, and quality of life between patients with and without CKD after CABG; and     (2) to analyze the relationships among body composition, physical activity, and physical     function in this population. It is expected that patients after CABG with CKD have the worse     body composition, physical function, and quality of life than patients after CABG without     CKD; and patients with higher physical activity levels have the better body composition,     physical function, and quality of life.   "
103452|NCT01931995|"     This research study is being done to gain a better understanding about brain networks that     may be involved in depression. The investigators plan to examine how these networks change     after the brain is stimulated with Transcranial Magnetic Stimulation (TMS). TMS is a way of     stimulating the brain in order to mildly activate or mildly suppress different brain areas,     and is used to treat some forms of depression. It is hoped that this study will facilitate     learning more about the structure and function of different brain areas and the ways that     they are interconnected to form networks, both in depressed people and in people without     depression. In this research study, the effects of TMS will be measured by obtaining     pictures of the brain with Magnetic Resonance Imaging (MRI) and with Positron Emission     Tomography (PET). More specifically, this will be accomplished with a combined MRI and PET     scanner, which is capable of simultaneously obtaining both MRI and PET images of the brain.     This scanning paradigm will allow the assessment of local metabolic changes resulting from     TMS (with PET images) and brain network changes resulting from TMS (with fMRI). Changes     resulting from TMS between 20 subjects with depression and 20 healthy volunteers will be     calculated and will form the main outcome measure.   "
103453|NCT01931982|"     The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion     in the heart of patients with type 2 diabetes   "
103454|NCT01931969|"     This study is planned to compare right internal jugular vein catheterization entry points     determined by ultrasound and the central landmark guided method, and the relationship of each     with sternocleidomastoid muscle length and body mass index.   "
103455|NCT01931956|"     Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve     Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day,     6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms:     a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did     not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for     consideration for either Emergency Use (EU) or Compassionate Use (CU).   "
103456|NCT01931943|"     Brief Description:      This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate     Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients     with advanced breast cancer.   "
103457|NCT01931930|"     In the current study the effects of proprietary Perilla frutescens leaf extract in comparison     to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal     discomfort and bowel function were investigated. The study was performed double-blind and     placebo-controlled with a 4 week intervention period. Study products were taken two times     daily (each one capsule before breakfast and dinner).   "
103458|NCT01931917|"     The purpose of the pilot study is to examine the effects of the Incredible Years Baby     Programme (IY baby) offered as a universal intervention compared to Usual Care (UC) for     parents with infants aged 0-12 months.   "
103459|NCT01931904|"     The purpose of this study is to determine if lowering the pressure inside the eye improves     blood flow to the eye.   "
103460|NCT01931891|"     Preeclampsia affects 2% to 8% of all pregnancies and is a major cause of maternal morbidity     an mortality worldwide.Althought the primary pathology leading to preeclampsia is remain not     known, complex pathophysiologic pathways and mechanisms have been described.      New blood vessels evolve during angiogenesis and vasculogenesis, two physiological processes,     that play a crucial role in embryogenesis and placentation. Structural alterations in the     human umbilical cord, maternal spiral arteries can cause adverse fetal     consequences.Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the     umbilical cord. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans     in comparison to control tissue.      Matrixmetalloproteinases (MMPs) are a family of proteolytic enzymes that degrade various     components of the extracellular matrix (ECM). A Disintegrin And Metalloproteinases (ADAMs)     and ADAMs with Thrombospondin motifs (ADAMTS) are proteinases closely related to Matrix     Metalloproteinases (MMPs). Dysregulation of ADAMs and ADAMTS expression have been reported in     different types of pathologies such as cancer, osteoarthritis, neurodegenerative inflammation     or asthma.      The role of ADAMTS in the pathomechanism of pre-eclampsia has not been studied until now. We     therefore decided to compare the ADAMTS composition of the umbilical cord and placenta from     newborns of mothers with pre-eclampsia with those with normal pregnancy.   "
136838|NCT01493739|"     This study aims on the combinatorial results of cytology, histopathology and microbiology     obatined by EBUS-TBNA for unselected mediastina lesions.   "
103466|NCT01931813|"     This project is the pilot step necessary to develop a system of vaccination     pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for     this challenge and case series analysis, with the use of linked medicoadministrative data for     hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative     data is new in France. The example of the risk of hospitalisation for febrile convulsions in     infants less than two years old following vaccination against diphtheria, tetanus and     pertussis is given as the reference association. This choice is justified by the numerous     publications over many years on the existence of this association (Miller et al BMJ 1981,     Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to     assess this risk, the results can be compared directly (Lancet 1995). The study to determine     whether the analysis tools are suitable for the data will be tackled at the following levels:        -  Validity of the selection of cases from administrative records alone using coding based          on the international classification of diseases ICD10        -  Validity of the risk assessment. This methodology feasibility project must make it          possible to identify the different potential problems. This is a prerequisite necessary          for the systematic implementation.   "
103467|NCT01931800|"     -  4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will          be taken from the patient within 24 hours following inclusion (D0) in the department in          which the patient is hospitalised        -  4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will          be taken from the patient every 7 days following inclusion for 5 weeks (if the patient          is still in hospital at the time), in the department where he/she is hospitalised (D7,          D14, D21, D28, D35). Samples will no longer be taken once the patient has left the CHU,          even if all of the samples have not been taken.        -  For children less than 6 years old, only 2 tubes (1 x 7 ml dry tube with yellow gelose,          and 1x5 ml tube with blue CTAD) will be taken following the same timetable.        -  For hospitalised patients, a leeway of 48 hours is authorized for the sampling          procedure. Samples will be taken at the same time samples are taken for the usual care          of the patient.        -  The tubes will be taken to the Bacteriology Laboratory using the usual collection          circuit of the CHU. These tubes will then be redirected to the Infectious Diseases          Laboratory to be centrifuged and then stored at -80°C. The strain of Streptococcus          pneumoniae isolated in the patient will be preserved at -80°C. If strains other than          Streptococcus pneumoniae are isolated, these different strains will all be preserved at          -80°C under the same identification number.   "
103468|NCT01931787|"     This pilot clinical trial studies CPI-613 (6,8-bis[benzylthio]octanoic acid) in treating     patients with relapsed or refractory small cell lung cancer. CPI-613 may interfere with the     growth of tumor cells and may be an effective treatment for small cell lung cancer.   "
103469|NCT01931774|"     Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that     may impair neurocognitive functions such as memory, attention, psychomotor speed, and     executive functions, which are also common psychiatric disorders in patients with acne.      The purpose of this study is to determine cognitive functioning in treatment naive acne     patients, without a history of any psychiatric disorder.   "
103470|NCT01931761|"     To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose     [14C] selumetinib in volunteers   "
103471|NCT01931748|"     The Purpose of this study is to evaluate in a randomized, double-blind, Parallel,     Non-inferiority, Multicenter, the efficacy and safety of UNCNT in comparison to the active     comparator of MELSMON in female having menopausal syndrome. Patients will be allocated     randomly to receive either UNCNT or MELSMON.      Through the injection of UNCNT to female having menopausal disorder, efficacy in the     improvement of the menopausal symptoms by Kupperman index is to be evaluated and compared     with MELSMON.   "
103472|NCT01931735|"     Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical procedures     in the VA system. There remains substantial uncertainty, however, regarding the short term     benefits and the long term consequences of arthroscopic meniscectomy in patients with     degenerative meniscus tears. Of major concern is the fact that degenerative meniscus tears     are associated with osteoarthritis, and it is known that within two years of surgery,     arthroscopic debridement for osteoarthritis is no better than placebo in relieving pain and     restoring function. Longer term, meniscectomy has been shown to be associated with elevated     risk of osteoarthritis development, raising the concern that meniscectomy can actually be     harmful. The purpose of this study is to determine whether meniscectomy in the setting of a     degenerative meniscus tear is of any clinical value. Determining this would either justify     the expenses associated with arthroscopic meniscectomy on a large number of patients, or     would identify an area of significant potential cost savings.   "
103473|NCT01931722|"     Likely, branched chain amino acid (BCAA) requirements are increased in older strength-trained     (ST) individuals. If so, supplementation in this group will maximize muscle protein synthesis     (MPS) and minimize loss of muscle with age (sarcopenia).   "
104381|NCT01919866|"     Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in     combination with a toxicity reduced conditioning regimen or with standard conditioning     regimens according to underlying disease.   "
103474|NCT01931709|"     This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and     dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to     treatment in patients with breast cancer. Comparing results of diagnostic procedures done     before, during, and after chemotherapy may help doctors predict a patient's response to     treatment and help plan the best treatment.   "
103475|NCT01931696|"     The purpose of this study is to assess whether acupuncture is effective in the treatment of     chronic asthma.   "
103476|NCT01931683|"     The investigators attempted to determine the optimal effect-site concentration of     remifentanil for smooth removal of the LMA from propofol anesthesia.   "
103477|NCT01931670|"     A randomized study evaluating the safety and efficacy of elagolix in the management of     moderate to severe endometriosis-associated pain in adult premenopausal female subjects.   "
103478|NCT01931657|"     Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea     and reduce bleeding irrregularities during the initial months of Mirena use.   "
103480|NCT01931631|"     The purpose of the study is to assess whether, in individuals with type 2 diabetes, a     low-fat, vegan diet improves blood glucose control more effectively than a control diet based     on current American Diabetes Association (ADA) guidelines. The principal measure is     hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The     study duration is 20 weeks with a one-year follow-up.   "
103481|NCT01931618|"     The purpose of this study is to test - in a workplace setting - if an online multi-session     alcohol intervention improves treatment effect over and above a single session screening with     feedback.      Hypothesis: automated online multi-session follow-up improves the effect on alcohol     consumption over and above a single session screening   "
103482|NCT01931605|"     Background: Patients with indwelling urinary catheter for chronic retention due to     obstructive BPH refractory to medical therapy are candidates for prostatectomy still     considered as the gold standard of treatment. Urinary tract infection, strictures,     postoperative pain, incontinence, sexual dysfunction, anesthesiologist risk and blood loss     are complications associated with surgery. Minimally invasive treatments were originally     conceived as an attempt to offer equivalent efficacy without the burden and risk of operative     morbidity. Recently, it was suggested that prostatic arterial embolization (PAE) to treat BPH     might follow uterine artery embolization for uterine leiomyomas. Animal studies in pigs and     dogs have shown that PAE is safe and can induce prostatic volume reduction. The first report     of this technique in the management of BPH in humans was by DeMeritt et al, who reported a     single case of BPH with obstructive symptoms and blood loss refractory to other treatments     that was successfully managed by PAE with polyvinyl alcohol (PVA) particles.      Objective : We investigate whether PAE might be a feasible procedure as an alternative     treatment option to treat urinary retention due to obstructive BPH. The primary objective is     to evaluate the success rate of procedure defined when selective prostatic arterial     catheterization and embolization were achieve and patients can be able to urinate after their     urinary catheter has been removed.      Patients and methods : A monocentric prospective study is undertaken in 25 patients aged     50-85 years who present with indwelling urinary catheter due to obstructive BPH refractory to     medical treatment with a clinical indication for surgery who agreed to undergo PAE. The study     is approved by the hospital ethical committee and an informed consent form for PAE as an     alternative treatment is signed by all participants.      Statistical analysis : The sample size has been calculated in order to have an estimated     probability of success (corresponding of primary objective) of 50% (worst case) with 95%     confidence intervals of 30 to 70. The two-sample t-test (and Wilcoxon rank-sum test) is used     to compare the mean changes of the variables from baseline to 10, 30 and 90 days. Finally,     the Chi-square test is used to test for adverse events at the end of follow-up. P ≤ 0.05 is     indicative of statistically significant.   "
103483|NCT01931592|"     Rapid and rational health-care interventions are of great importance to efficiently combat     the emergence of resistant and virulent bacteria. In recent years, spread of ESBL-E on a     global level has been observed.      For ESBL-E, effective eradication regimens are not yet available. The current study therefore     aims to assess a new approach to ESBL-E eradication. To avoid administration of the     eradication regimen to patients at low risk of subsequent BSI with ESBL-E, the study     population will be restricted to immunocompromised high-risk patients.   "
103484|NCT01931579|"     Solitary pulmonary nodule has become a major challenge in respiratory clinical practice.     According to published guidelines, their management often requires close CT follow up, PET CT     and invasive procedures to obtain a definite histology. In this context, innovative     endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for     the localization and sampling of peripheral lung nodules. However, these techniques are     unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal     endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based     confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of     the distal lung structures in real time.      This prospective trial we will assess confocal endoscopy as a tool to localize the peripheral     lung nodules and to differentiate benign from tumoral lesions.      Objective(s)        1. To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy          for the localisation of peripheral lung nodule        2. To demonstrate that confocal endoscopy can differentiate benign from malignant tumors      Experimental design:      Multicentric prospective controlled trial, conducted in three academic centers, specialized     in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based     confocal endo-microscopy.      Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored     using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted     in the same catheter as used for the navigational bronchoscopy and confocal images will be     recorded before sampling. An ancillary study using topical methylene blue as in situ will be     conducted at the Rouen University Center.      An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal     endo-microscopy analysis.   "
103485|NCT01931566|"     The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the     risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to     evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in     cognitively-normal participants who are at high-risk for developing MCI within 5 years.   "
103508|NCT01931267|"     The purpose of this 4-year study is to investigate the relationship between cognition and     learning ability on patients with COPD during hospitalization to establish and evaluate the     effects of the community-extended discharge planning program. The transition theory is used     as the theoretical base in this study. The patients with diagnosis of COPD in hospital will     be invited to participate. The data of demographic variables, the cognitive function¸ the     respiratory function, the effect of learning and the usage of medical resources after     discharged will be collected. In the first year, we will establish the protocol of     respiratory teaching in two modes, and to compare the differences among computer interaction     game intervention, face to face teaching and routine nursing intervention, also to evaluate     the related factors and the effect of learning on patients with COPD for determining the     needs of patients' learning mode and the optimal frequency of nursing teaching mode during     hospitalization in the second year. For the second year, build upon the results of the first     year, the preliminary draft of the community-extended discharge planning program that base on     the experts' meeting and the interview with the patients. Also, a pilot study that revising     the content and testing the feasibility of respiratory teaching protocol will be conducted.     For the 3rd and 4th year, using case-control RCT design, the community-extended discharge     planning program will be tested in patients during their hospital stay and post-discharge     period. The effects of this community-extended discharge planning program will be evaluated     on outcome variables of patients' cognitive learning function, utilization of health care     resources. The results of this study will help to develop a community-extended discharge     planning for patients with COPD on cognition level and learning ability. Furthermore, the     protocol of the community-extended discharge planning will serve as references to prolong the     development of disease deterioration, reduce the probability of readmission and improve the     quality of life.   "
103486|NCT01931553|"     Attending morning rounds take place at teaching hospitals every day. They are the primary     mechanism for patient care delivery, supervision and education of trainees, and communication     with patients, families, and staff. However, they are done with little standardization or     widely recognized best practices.      The objective of this quality improvement (QI) initiative is to evaluate the adherence to and     impact of implementing standardized attending morning rounds on medicine teams at our     institution. A standardized rounding intervention has been developed which includes specific     guidance on completing the following activities during morning rounds: (1) Pre-rounds     discretion; (2) Pre-rounds huddle; (3) Bedside registered nurse (RN) integration; (4)     Patient-centered rounding; (5) Real-time order writing.      This trial will randomize half of the investigators' medicine teams at University of     California San Francisco to this rounding intervention whilst the other half will be     randomized to continue with usual unstandardized rounding practices.      The investigators will compare medicine teams randomized to undertake standardized rounding     to those teams undertaking usual practice. Outcomes assessed will relate to the patient (e.g.     satisfaction), providers (e.g. satisfaction), efficiency (e.g. total morning round time) as     well as adherence to the intervention .      The investigators' study hypotheses are that patient satisfaction scores will be higher for     those patients receiving standardized bedside rounds compared to the usual care group. The     investigators also hypothesize that total attending morning rounds time and interns length of     workday will be shorter and that the number of consultations ordered before noon will     increase for those teams undertaking standardized bedside. Further, the investigator     hypothesize higher levels of nurse participation, physician and medical student satisfaction     with standardized bedside rounding.   "
103750|NCT01928108|"     The purpose of this investigation is to prospectively evaluate the benefit of different     methods of educating patients regarding their fluid intake through a readily available daily     cellular phone application to improve overall urine output and reduce risk factors for stone     recurrence.   "
103487|NCT01931540|"     The prevalence of obesity in the developed world has increased markedly over the last 20     years. Considering the prevalence of obese and overweight adult subjects, and the fact that     pregnancy itself induces a state of insulin resistance and inflammation, maternal obesity may     be the most common health risk for the developing fetus. It is well established that what we     eat has a major impact on our health. However, there is growing evidence to suggest that diet     during pregnancy and lactation may be particularly important as not only does it influence     the health of the mother, it may have a permanent effect on the health of her children and     even her grandchildren. The concept that environmental factors, such as nutrition during     early development, influence both our health span and lifespan has been termed the     developmental origins of health and disease hypothesis.      The objective of the study are:        -  to compare subjects with frailty (condition developed with ageing) with controls and          characterize the unhealthy aged condition with the measurements described below        -  to examine if signs of frailty can be reversed by lifestyle induced modifications          (exercise training programme) of its primary components (IR, sarcopenia, psychological          profile) in offspring of overweight/obese (OOM) vs lean mothers (OLM).      The study consists of 37 frail old subjects, age ≥ 65 sub-grouped in 17 OOM, and 20 OLM and     11 non frail controls. These subjects will be studied with positron emission tomography     (PET), computed tomography (CT), magnetic resonance imaging (MRI) and spectroscopy (MRS) and     ultra sounds (US). In addition functional MRI (fMRI) will be performed. Adipose tissue     biopsies will be taken.      Subjects will undergo characterization of biohumoral markers, a 75 g oral glucose tolerance     test, imaging biomarkers (PET/CT, US, fMRI-MRS), genetic biomarkers (DNA and telomere damage)     and inflammatory biomarkers (macrophage infiltration) before and after the 4-month lifestyle     intervention period (physical exercise). By PET/CT it will be measured tissue-specific IR in     skeletal muscle, adipose tissue, liver, myocardium and targeted brain regions. MRS will be     used to measure organ steatosis in the skeletal muscle and liver, MRI will be used to measure     fat masses in abdominal areas, and fMRI will be performed to assess activation in brain     regions regulating cognition and appetite/energy control. US will be used to assess     cardiovascular markers (IMT, strain and function).   "
103488|NCT01931527|"     The purpose of this study is to learn more about what is the effect of uric acid on oxidative     stress and on the way the body metabolizes sugar in obese people. Understanding this may lead     to better diseases such as diabetes.   "
103489|NCT01931514|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Montelukast Sodium chewable 5mg tablet and Innovator's(Merck)Singulair chewable 5mg     tablet. Dosing periods were separated by a washout period during fed study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
103490|NCT01931501|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5     mg tablet. Dosing periods were separated by a washout period during fasted study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
103491|NCT01931488|"     The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation     and Assessment of Neuroendocrine tumors. Comparison with 123I-MIBG.   "
103492|NCT01931475|"     The purpose of this study is to assess the efficacy and safety of duloxetine once daily     compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in     participants in China.   "
103493|NCT01931462|"     Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney)     tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the     edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most     common technique is to clamp the blood supply to the entire kidney during removal and to     surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood     supply to the entire kidney including the healthy tissue, which can cause damage to the     remaining tissue due to a shortage of oxygen if left clamped too long.      This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a     bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping     the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If     adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading     to the remaining tissue, clamping and a shortage of oxygen can be avoided.      The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage     of bleeding during partial kidney removal.   "
103494|NCT01931449|"     The purpose of this study is to evaluate the validity and safety of a modified operative     procedure of digestive tract reconstruction following pancreatoduodenectomy which enables the     pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at     gastrointestinal anastomosis. It is anticipated that this procedure can decrease the risk of     post-surgical pancreatic leakage and preserve the patients' digestive function as well.   "
103495|NCT01931436|"     This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills     in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as     psoralen and Isopsoralen will be detected.   "
103496|NCT01931423|"     To determine whether early placental drainage plus cord traction reduces the incidences of     manual removal and blood loss, and to determine the risk factors associated with blood loss     after delivery.   "
103497|NCT01931410|"     The investigators hypothesis in this study is that administration of rectal and sublingual     misoprostol decreases intrapartum and postpartum haemorrhage.   "
103613|NCT01929889|"     The study looks at whether treatment with iloperidone (Fanapt) is associated with     improvements in social cognition in individuals who have been recently diagnosed with     schizophrenia or schizoaffective disorder. Social cognition (the ability to understand your     feelings and the feelings of others) is closely related to functional outcomes, including     communication, empathy, and emotional recognition.   "
103498|NCT01931397|"     Kidney transplantation is the treatment of choice for kidney failure in children. Kidney     transplant recipients need to take immunosuppression for the rest of their lives after     transplantation to prevent rejection of the graft. One of the important medications is called     Tacrolimus which can prevent rejection of the kidney graft but at the same time is toxic to     the kidney. Therefore, repeated blood levels of Tacrolimus with tests of kidney function will     help physicians to prescribe the best dose for therapy to prevent kidney rejection and kidney     toxicity. Failure of compliance with taking Tacrolimus is also an important cause of graft     failure especially among teenagers, so repeated blood Tacrolimus levels are necessary to     detect patients who fail to take their medications on a regular basis. We have developed a     lab assay that measures Tacrolimus blood level and creatinine (for kidney function) using one     dried blood spot (DBS) on filter paper similar to the filter paper used in the new born     screen. We plan to teach patients how to do the test at home once a month and mail the filter     paper back to OHSU for analysis for Tacrolimus and creatinine. The advantage of this method     is that it is less painful for children then a regular blood dray from the vein, can be done     easily at home, will be most cost effective as it will save the family a day of work or     school and can detect both the Tacrolimus level and the kidney function at the same time.      We will assess the effect of doing this simple finger prick at home on compliance, on     Tacrolimus levels and kidney function over the study period of one year. We will also assess     how satisfied patients are with this method instead of going to the lab or the hospital for     blood test. All subjects will continue on their regular clinic visits and will continue to     have their routine blood draws by intravenous method in the lab during the study.   "
103501|NCT01931358|"     The primary purpose of the study is to better define the relative contributions of AIDSVAX®     B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed immune     profile in the weeks and months after receiving the original prime and boost vaccine regimen     from study protocol RV 144, and their booster effects in both the systemic and mucosal     compartments. In addition, this study will provide more intensive and comprehensive     characterization of the innate, cell-mediated and humoral immune responses than possible     within the RV 144 study.   "
103502|NCT01931345|"     In 2009, a team of researchers from Montreal, Canada, implemented SPOT, an intervention aimed     at reducing HIV transmission among men who have sex with men by offering rapid HIV testing in     a community setting. During the first phase, counseling based on Quebec guidelines for rapid     HIV testing was offered (standard counseling - SC) and in the second phase, counseling based     on motivational interviewing (MIC) was developed and validated. The current phase of the     project aims to strengthen the work undertaken during previous phases. The objective of the     study is to assess the short and medium term effect of MIC on the occurrence of at-risk anal     intercourse and its cognitive determinants. Participants will be randomly assigned to either     SC or MIC, and will respond to a baseline questionnaire documenting their sexual behavior and     psychosexual profile prior to the intervention at the start of their initial visit (T0). The     effect of counseling will be assessed following the intervention at the end of the initial     visit (T1), at 3 months after the initial visit (T2) and at 6 months after the initial visit     (T3).   "
103503|NCT01931332|"     Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early     post-operative pain. The primary aim of this study was to investigate the impact of either a     single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain     after TKA      The Null Hypothesis is that there is no difference in the post operative pain relief provided     for TKA by a single-shot femoral nerve block (FNB) as compared to intrathecal diamorphine     (ID).   "
103504|NCT01931319|"     The objective of this study is to determine safety and characterize pharmacokinetics of     higher doses of intravenous baclofen in healthy subjects.      This study is a non-randomized dose escalation study. Three subjects will receive 10 mg doses     of IV baclofen, two or more days later the next three subjects will receive 15 mg baclofen     intravenously, and two or more days later the last three subjects will receive 20 mg IV     baclofen.      The pharmacokinetic and tolerability information gained from this study will support the     development of further studies to assess the use of IV baclofen to prevent or treat baclofen     withdrawal syndrome.   "
103505|NCT01931306|"     To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib     in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring     Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR     tyrosine kinase inhibitor (TKI)   "
103506|NCT01931293|"     Patients with atrophic glossitis (AG) or burning mouth syndrome (BMS) are frequently     encountered in the oral mucosal disease clinic. Our previous studies found a significantly     higher frequency (26.7%) of serum gastric parietal cell antibody (GPCA) and a significantly     higher frequency (31%) of serum thyroglobulin antibody (TGA) or thyroid microsomal antibody     (TMA) in AG patients than in healthy control subjects. Moreover, there is also a     significantly higher frequency (13.3%) of serum GPCA or a significantly higher frequency     (23.5%) of serum TGA or TMA in BMS patients than in healthy control subjects. Because     patients with one organ-specific autoantibody are prone to have another organ-specific     autoantibody in sera, we also evaluated whether AG or BMS patients with GPCA are prone to     have TGA or TMA in sera and vice versa. We further found that 25.3% of TGA- or TMA-positive     AG or BMS patients also have GPCA, 32.3% GPCA-positive AG or BMS patients also have TGA, and     30.6% GPCA-positive AG or BMS patients also have TMA in their sera. Without proper diagnosis     and treatment, patients with GPCA are more likely to develop autoimmune atrophic gastritis     and subsequently progress to gastric carcinoma, and patients with TGA or TMA may develop     autoimmune thyroid disease and finally result in thyroid dysfunction. In addition, previous     studies have shown a close association of the HLA-DR or HLA-DQ loci with the presence of     autoantibodies (such as GPCA, TGA or TMA) in patients with different types of autoimmune     disease. Therefore, in the following 3-year research project, we plan to collect 300 AG and     450 BMS patients from the oral mucosal disease clinic of Department of Dentistry, National     Taiwan University Hospital. For each year, 100 AG and 150 BMS patients are collected. A 10-cc     blood sample will be drawn from each patient, with 5 cc being used for the determination of     the serum levels of GPCA, TGA and TMA and another 5 cc being used for the HLA-DRB1 and     HLA-DQB1-genotyping using the polymerase chain reaction with sequence-specific primer     (PCR-SSP) typing technique. At the end of this 3-year study, we will realize the frequencies     of presence of GPCA, TGA and TMA in sera of our 300 AG or 450 BMS patients. After statistical     analyses, we will also know which specific HLA-DRB1 or HLA-DQB1 allele and which specific     DRB1-DQB1 haplotype are responsible for the possession of GPCA, TGA or TMA in sera of our AG     or BMS patients. In addition, we will understand which specific HLA-DRB1 or HLA-DQB1 allele     and which specific DRB1-DQB1 haplotype are responsible for the possession of GPCA in TGA- or     TMA-positive AG or BMS patients as well as for the possession of TGA or TMA in GPCA-positive     AG or BMS patients. With this important information in mind, we can predict the development     of the specific autoimmune diseases such as autoimmune atrophic gastritis and autoimmune     thyroid diseases and then adopt proper early diagnosis and treatment to prevent the future     occurrence of these diseases and their potential complications (such as gastric carcinoma or     thyroid dysfunction).   "
103507|NCT01931280|"     This study includes a behavioral educational intervention that focuses on healthy eating,     physical activity and glucose management during pregnancy and post partum among women newly     diagnosed with gestational diabetes mellitus (GDM).   "
103614|NCT01929876|"     This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect     of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy     participants. Participants will receive multiple repeating doses of cobimetinib and     itraconazole.   "
103509|NCT01931254|"     In the past 70 years antibiotics have served as the first line of defense against infectious     diseases. However, antibiotics are only effective against bacterial infections and are not     the solution for infections caused by viruses such as common colds or flu. Despite their     contribution to healthcare, antibiotics are currently recognized as the most misused drugs in     the world with global overuse estimated at 40%-70%, mostly due to the ineffectiveness of     current diagnostic solutions to distinguish between bacterial and viral infections.     Antibiotics misuse often causes preventable adverse events that impact patient care and lead     to the emergence of antibiotic-resistant bacteria, one of the major threats to global health     today. To address these challenges, MeMed has been developing the ImmunoDx™, a novel     technology that relies on the best available detection system for differentiating between     viruses and bacteria - the body's own immune system. The ImmunoDx™ technology employs a     simple blood test that provides the physician, within two-hours, the information he needs to     decide whether to treat the patient with antibiotics or not. This technology has been tested     on over 1000 patients of different ages and diseases and was found to be highly accurate and     safe. The current study is a non-interventional study and the participants do not receive any     investigational drug nor any experimental examination or procedure. Therefore, the collected     data in this study will not affect the diagnosis, prognosis, or treatment of the     participants. Participation includes the collection of a teaspoon of blood and collection of     a specimen using a nasal swab. These procedures are common in the clinical practice and are     widely performed and possess no significant risk. By participating in the study, the subjects     impact the development of the ImmunoDx™ technology, which is expected to enable a future     faster and more accurate diagnosis of infectious diseases as well as more appropriate     prescription of antibiotics. This will open the way to improve treatment decisions in     millions of patients around the world.   "
103510|NCT01931241|"     Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL     cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque burden.   "
104568|NCT01917435|"     The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and     the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth     opening patients.   "
103511|NCT01931228|"     Respiratory failure after extubation is a relevant consequence of poor airway clearance due     to respiratory muscle weakness and respiratory failure after extubation and reintubation is     associated with increased morbidity and mortality.      the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in     Preventing Respiratory Failure After Extubation as compared manually assisted coughing   "
103512|NCT01931215|"     Analgesia after cesarean section is still not satisfactory for many women. Even if pain     reduction is sufficient with the technique of intrathecal morphine injection, side effects     such as nausea and pruritus are common.      Since several years, an alternative technique has been studied, the transversus abdominis     plane (TAP)-block. Here a local anesthetic is injected in the abdominal wall muscles, and     this has been shown to give a similar analgesic effect compared to intrathecal morphine, with     potentially less side effects.      With this study, we want to evaluate if the TAP-block yields indeed less side effects when     compared with intrathecal morphine.      The study will be a prospective study with the patients randomized to either a group with     intrathecal morphine or a group with TAP-block.   "
103513|NCT01931202|"     This project seeks to elucidate the mechanisms by which antidepressant medications have     limited efficacy in Late Life Depression (LLD) in order to develop new treatment     interventions for this prevalent and disabling illness. We hypothesize that the presence of     executive dysfunction (ED),which is common in depressed adults over 60, impairs the ability     to form appropriate expectancies of improvement with antidepressant treatment. Greater     expectancy has been shown to improve antidepressant treatment outcome and is hypothesized to     be a primary mechanism of placebo effects. Moreover, white matter hyperintensities (WMH) on     magnetic resonance imaging (MRI) are more prevalent in patients with LLD compared to healthy     controls. It has been argued that WMH contribute to the pathogenesis of LLD with ED and     decrease the efficacy of antidepressant medications by disrupting connections between     prefrontal cortical (PFC) and subcortical structures. Vascular lesions to white matter tracts     may also compromise the pathway by which expectancy-based placebo effects influence     depressive symptoms. Expectancies reflect activation in PFC areas that may improve depressive     symptoms by modulating the activity of subcortical regions subserving negative affective     systems (i.e., amygdala) as well as those important in reward and hedonic capacity (nucleus     accumbens and ventral striatum). Thus, LLD patients withED and WMH may sustain a double-hit     to their ability to experience placebo effects in antidepressant treatments: ED diminishes     the ability to generate appropriate treatment expectancies, while WMH disrupt the physiologic     pathways by which expectancies lead to improvement in depressive symptoms.   "
103514|NCT01931189|"     The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and     infliximab(the comparator) in Japanese healthy volunteers   "
103515|NCT01931176|"     Dengue viruses can cause dengue fever and other more serious illnesses. The purpose of this     study is to evaluate the safety and immune response to a dengue virus vaccine.   "
103516|NCT01931163|"     RATIONALE: Everolimus plus Cisplatin may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth and by blocking blood flow to the tumor.      PURPOSE: The purpose of this study is to test how effective combing a Cisplatin chemotherapy     with Everolimus is in treating subjects with residual triple negative breast cancer, who have     already received chemotherapy prior to surgery.   "
103517|NCT01931150|"     The purpose of this study is to see if the investigators can prevent or reduce the severity     of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin.     One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an     FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin     moisturizers are recommended to patients who receive Cetuximab treatment. In addition to     these topical agents they will be given a pill to take once a day. This pill has already been     shown to help fight rashes from Cetuximab.   "
103518|NCT01931137|"     This trial is conducted in Europe. The aim of the trial is to investigate the     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the     effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet     formulation with three different coatings in healthy subjects.   "
103519|NCT01931124|"     Aim of the study is to investigate the effect of different types of training (high intensity     and moderate training) on maximal oxygen uptake and activity levels in an elderly Norwegian     population after one year training intervention. Baseline data include the activity levels     assessed through self reported means as well as objectively measured activity data using     activity monitors.   "
103520|NCT01931111|"     This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to     find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which     cardiovascular risk parameter clustering is apparent in an elderly Norwegian population.   "
136841|NCT01493700|"     The purpose of this study is to compare the effect of electrically heated humidifier on the     body temperature during shoulder arthroscopy.   "
103534|NCT01930929|"     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater     extent as treatment of obesity to obtain a greater and more permanent weight loss. The     currently most commonly used surgical method is the gastric bypass (RYGB), which so far has     proved to be the most effective way to achieve a greater and more permanent weight loss,     reduction and maybe even elimination of many of the obesity-related health complication     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).      Bariatric surgery, including RYGB is also associated with medical and nutritional     complications. This will be a natural consequence of the fact that the food bypasses     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and     vitamin D substitution. In spite of this, many develop various nutritional problems after     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia     and gallstone attacks after RYGB.      Nevertheless there is no comprehensive inventory of the occurrence of nutritional     complications after bariatric surgery neither in Denmark nor in an international context.     Thus there is no consensus on an optimal postoperative prevention of complications. An     overview of the occurrence of these problems will be important for assessing and determine     the indications for bariatric surgery as well as to optimize the prevention of complications.      To enlighten this we will conduct a cohort study of complications by investigating     hospitalizations and deaths after RYGB. Moreover we will get an overview on medication use     before and after RYGB operation in the Central Denmark Region and in the North Denmark Region     2006-2011 (about 5000 patients).   "
104569|NCT01917422|"     Dengue virus serological reagent, included antigen and antiserum, is a serum test for     identification of serum antibodies to dengue virus.   "
103521|NCT01931098|"     Background:      Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug     pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat     lung cancer. Both topotecan and pazopanib have individually been used to treat patients with     glioblastoma and some anti-tumor activity has been found. Researchers want to see if these     two drugs together may be able to help people with glioblastoma.      Objectives:      To learn if pazopanib with topotecan can help control glioblastoma. Also, to study the safety     of this drug combination.      Eligibility:      Adults at least 18 years old whose glioblastoma has returned after treatment.      Design:      Participants will be screened with:      Medical history      Physical exam      Blood and urine tests      Brain computed tomography (CT) or magnetic resonance imaging (MRI) For these, participants     lay in a machine that takes pictures.      Chest CT scan or x-ray      Heart electrocardiogram (EKG)      A questionnaire about quality of life      Participants will be assigned to a study group.      Participants will take the study drugs for 28-day cycles for up to 1 year. They will take     capsules of topotecan by mouth once every day. They will take tablets of pazopanib by mouth     once every day.      Participants will write in a diary the times they take the study drugs.      Participants will have several study visits during each cycle. These may include      Blood pressure measurement      Blood and urine tests      EKG      Physical exam and/or neurological exam      Brain MRI or CT scan to check the status of the disease      A symptom questionnaire      At the end of treatment, participants will have a physical exam. They may have blood drawn.      Participants will have follow-up calls once every 3 months to check.   "
103522|NCT01931085|"     Triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary     practice. Triclabendazole is considered to be a second-line drug for parasites and is used     when other preferred agents cannot be used because they are ineffective or because adverse     reactions limit their use. Although Triclabendazole is widely used in developing countries     for the treatment of parasites it is not approved by the FDA for this treatment in the US. It     is currently being distributed in the US through a special arrangement with the FDA and the     manufacturer on an individual patient approval basis. This arrangement requires that a single     patient Investigational New Drug (IND) be obtained from FDA for each patient requiring     Triclabendazole. Upon approval by FDA, the manufacturer (Novartis) will ship the drug     directly to the prescribing physician.   "
103523|NCT01931072|"     The purpose of the study was to investigate whether regular moderate- or high-intensity     interval training can change the DNA methylation in a long-lasting state, and whether these     changes affect the gene expression. In addition, the investigators will determine whether the     intensity of the training could be an affecting factor of the possible DNA-methylation change     as well. The null hypothesis was that no such exercise-induced changes occur.   "
103524|NCT01931059|"     To detect functional correlation changes in the brain with anti-psychotic drug administration     as compared to placebo, and b.) to measure if these changes correlate with the plasma level     of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms     and changes in cognitive function.   "
103525|NCT01931046|"     The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3     in subjects with localized prostate cancer.   "
103526|NCT01931033|"     This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a     treatment for social impairment in adolescents with autism spectrum disorders (ASD). We     hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the     core symptoms of autism spectrum disorders in adolescents ages 11-17.   "
103527|NCT01931020|"     RESEARCH HYPOTHESIS-In preterm neonates during heel lance oral 25% glucose is more     efficacious in reducing pain as compared to oral 24% sucrose when assessed by PIPP(Premature     infant pain profile)   "
103528|NCT01931007|"     The overall goal of this study is to develop regenerative cell therapy for use in patients     with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study     that assesses the safety and feasibility of using concentrated bone marrow aspirate     containing MSC to treat patients with painful knee OA.   "
103529|NCT01930994|"     A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years of     used and Jadelle during five years of use by Kenyan women.   "
103530|NCT01930981|"     We are interested in studying whether and how medical problems other than primary cancer     before hematopoietic cell transplantation would impact the profiles of quality of life and     toxicities post-transplantation for patients with blood cancers. We want to see if by     assessing comorbidities (such as diabetes) early on, we can identify those patients who will     have more toxicities or limitations in their quality of life after transplant. The generated     information could set the stage for future intervention studies aiming to improve quality of     life for patients with blood cancers after transplantation.   "
103531|NCT01930968|"     The study will test the usefulness of a contrast agent to help image tumors in the eye. In     this study, patients with eye melanoma who are going to have their eye removed, will have     their eye imaged by ultrasound (sound waves) before and after intravenous injection of     microbubbles. The pathology characteristics of the tumor in the removed eye will be compared     with the images.   "
103532|NCT01930955|"     Some acute upper respiratory tract infection(AURI) in children is characterized by fever and     vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC)     usually increased in this children patients,hence antibiotics are often prescribed properly     assumed. In the present study, it was hypothesized that it was not necessary to prescribe     amoxicillin for the children.   "
103533|NCT01930942|"     The aim of this study is to find some genetic factors in predicting the sensibility of     preoperative chemoradiotherapy for locally advanced rectal carcinoma.   "
103545|NCT01930773|"     Patients undergoing percutaneous coronary intervention with a residual high platelet     reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The     strategies to overcome the issue consist of switch to a more potent antiplatelet medications     including prasugrel or ticagrelor. Economic constrains of many countries still do not allow     wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise     treatment according to genotype and phenotype characteristics of the patient may provide an     attractive solution combining high clinical efficacy with low budget impact.   "
103535|NCT01930916|"     Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the     treatment of thromboembolic disorders, which are among the most costly diseases in terms of     public health resources. According to the Agence française de sécurité sanitaire des produits     de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA     in 2008 (more than 1% of the French population). VKA are at the origin of many adverse     effects, given their narrow therapeutic window. They are the cause of the death of     approximately 5000 patients per year. The use of this therapy is a priority axis of     reflection for the Haute Autorité de Santé.      The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people,     is particularly affected by this problem.      University hospitals of our interregion, given their very substantial regional referral     activity, are actually involved in managing VKA adverse side effects.      Elderly population constitutes the majority of prescriptions. The main objective of this     study is to compare INR of people older than 75 years measured by traditional method with     those measured by capillary method with INRatio2 supply.      The secondary objective is to show that this measure is not affected by the presence or     absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as     to test the variability of INR measurement between different hospital.   "
103536|NCT01930903|"     The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not     possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug     Eluting Balloon.   "
103537|NCT01930890|"     The primary objective of the study is to evaluate the long-term safety and tolerability of     BIIB023 in participants with lupus nephritis (LN).   "
103538|NCT01930877|"     Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the     patient. The investigators seek to determine if the addition of systemic lidocaine can     improve the quality of recovery after spine surgery and reduce the requirement for opiate     therapy.   "
103539|NCT01930864|"     MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.   "
103540|NCT01930851|"     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater     extent as treatment of obesity to obtain a greater and more permanent weight loss. The     currently most commonly used surgical method is the gastric bypass (RYGB), which so far has     proved to be the most effective way to achieve a greater and more permanent weight loss,     reduction and maybe even elimination of many of the obesity-related health complication     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).      Bariatric surgery, including RYGB is also associated with medical and nutritional     complications. This will be a natural consequence of the fact that the food bypasses     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and     vitamin D substitution. In spite of this, many develop various nutritional problems after     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia     and gallstone attacks after RYGB.      Nevertheless there is no comprehensive inventory of the occurrence of nutritional     complications after bariatric surgery neither in Denmark nor in an international context.     Thus there is no consensus on an optimal postoperative prevention of complications. An     overview of the occurrence of these problems will be important for assessing and determine     the indications for bariatric surgery as well as to optimize the prevention of complications.      To enlighten this we will conduct a questionnaire survey of complications such as pain,     dumping and hypoglycemia after RYGB. Moreover we will the quality of life after RYGB     operation. We will invite 3500 RYGB operated patients the Central Denmark Region who have     been operated 2006-2011.   "
103541|NCT01930838|"     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater     extent as treatment of obesity to obtain a greater and more permanent weight loss. The     currently most commonly used surgical method is the gastric bypass (RYGB), which so far has     proved to be the most effective way to achieve a greater and more permanent weight loss,     reduction and maybe even elimination of many of the obesity-related health complication     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).      Bariatric surgery, including RYGB is also associated with medical and nutritional     complications. This will be a natural consequence of the fact that the food bypasses     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and     vitamin D substitution. In spite of this, many develop various nutritional problems after     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia     and gallstone attacks after RYGB.      Nevertheless there is no comprehensive inventory of the occurrence of nutritional     complications after bariatric surgery neither in Denmark nor in an international context.     Thus there is no consensus on an optimal postoperative prevention of complications. An     overview of the occurrence of these problems will be important for assessing and determine     the indications for bariatric surgery as well as to optimize the prevention of complications.      To enlighten this the investigators will conduct a clinical trial concerning complications     after RYGB. The investigators will examine 350 RYGB operated patients the Central Denmark     Region. From a medical interview, blood tests, Dual energy X-ray absorptiometry etc. it will     be possible to give a good estimate of the incidence of medical complications. The     investigators will explore complications such as: anemia, hypoglycemia, peripheral nerve     problems (especially neuropathies), vitamin D / osteoporosis and other mineral / vitamin     deficiencies that may be identified through blood tests. A control group of 30-40 age, sex     and body mass index matched individuals will go through the same examinations.   "
103542|NCT01930812|"     The purpose of this study is to compare, in patients with prostate or breast cancer, the     accuracy of 18F-NaF PET imaging to 99mTc whole body bone scans with single-photon emission     computed tomography (SPECT).   "
103543|NCT01930799|"     This study will assess the impact of a systematic bladder health screening and disease     education regimen as well as the implementation of a referral process on the quality of life     of multiple sclerosis patients with bladder dysfunction.   "
103544|NCT01930786|"     This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in     clinical practice. Treatment will be administered in accordance with physician standard     practice. All treatment decisions lie with the physician.   "
103546|NCT01930760|"     The proposed study is a randomized control trial evaluating the efficacy of two training     programs in increasing physician identification, documentation, and motivation of overweight     children. Pediatric primary care physicians will be recruited from the College of Physician     and Surgeons of Ontario and randomized into two practice-based interventions     (behavioural/educational) which are a one-time training attendance. The educational     intervention will focus on the medical management of pediatric obesity, the use of Body Mass     Index charts, and information about how obese children would like to be approached by their     physicians. The behavioural intervention will incorporate Motivational Interviewing tools in     addition to an abbreviated training program received by the educational intervention group.   "
103624|NCT01929746|"     The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019     (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75     mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of     this study in this study population is to assess the safety and tolerability of BIIB019     administered as a single SC dose (75 mg or 150 mg).   "
103547|NCT01930747|"     The objective of this study is to compare the value of deep neuromuscular block (NMB) (using     rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 mean alveoalr     concentration (MAC) inhalation (using sevoflurane) for the surgeon.      The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus     opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the     pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points     allow to calculate the abdominal compliance and the PV0.   "
103548|NCT01930734|"     Heart failure (HF) is a prevalent disease reaching 1-2% of adult population in developed     countries, and 10% in patients over 70 years. In the past HF patients had a 5-year mortality     rate of 60-70% of HF with high rate of hospitalization and disability leading to a HF     epidemic. Treatment improvements in the past decades have significantly reduced     hospitalization and mortality. However, there is an increasing subset of patients (>10%) with     advanced HF symptoms (functional class III/IV) for whom current management strategies are     limited and do not provide a significant improvement in morbidity, mortality and quality of     life.      Specialized HF clinics, implementing a comprehensive therapeutic approach, were suggested to     be beneficial in this population. However, the design of these clinics is variable with     different methods of follow-up, therapy and supervision. Intermittent infusions of dobutamine     were previously inconclusive regarding symptom alleviation and hemodynamic improvement and     raised a concern of increased mortality in HF patients. Furthermore, the evidence scope is     narrow since most trials including inconsistent and relatively high dobutamine dosages.     Accordingly, current guidelines do not provide specific recommendations for dobutamine     therapy in stable HF patients, and indication for treatment are limited for acute HF with     hypotension and signs of hypoperfusion, or alleviation of symptoms in severely symptomatic     patients in stage D HF.      The primary aim of the proposed study is to evaluate the impact of intermittent low-dose     dobutamine infusion on clinical and hemodynamic parameters in advanced HF patients treated in     a tertiary heart failure clinic in the setting of a randomized clinical trial. We hypothesize     that intermittent therapy with low-dose dobutamine will be associated with improved     functional capacity and quality of life among patients with advanced heart failure, thereby     providing evidence for beneficial effects of a potentially important therapeutic regimen in     this high risk population.   "
103549|NCT01930721|"     The angle at which an episiotomy can be made is a continuous variable. If the investigators     consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90     degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.   "
103550|NCT01930708|"     The primary objective of the study is to estimate the annualized relapse rate (ARR) in     participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl     fumarate (DMF) over a 12-month period.      The secondary objectives of this study in this population are to assess the impact of DMF     over a 12-month period on participants -reported health-related quality of life (HRQoL)     outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes,     and to characterize participants-reported adherence to DMF.   "
103551|NCT01930695|"     The study is designed to collect data of the performance and confirm the safety of the DX     (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent     atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX     functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected     to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial     sensing via a sensing dipole in the ventricular lead and therefore reduces the number of     implanted leads without sacrificing atrial information. Atrial pacing can not be provided but     is not needed in patients with permanent atrial fibrillation.   "
103552|NCT01930682|"     The EARLY-MYO (EARLY routine catheterization after alteplase fibrinolysis vs. primary PCI in     acute ST-segment elevation MYOcardial infarction) is an investigator-initiated, prospective,     multicenter, randomized (1:1), open-label, actively-controlled, parallel group,     non-inferiority trial comparing the efficacy and safety of a PhI strategy with half-dose     fibrinolysis versus PPCI in STEMI patients presenting within 6 hours after symptom onset and     with an expected PCI-related delay of ≥60 min.   "
103553|NCT01930669|"     The purpose of this study is to measure the dysfunction of the autonomic nervous system in     modulating the heart rate variability and baroreflex control in critically ill.   "
103554|NCT01930656|"     Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available     online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests     using the American high risk cut-points for considering treatment but also suggests deriving     domestic cut-points from cost-effective approach. Establishing cost-effective domestic     cut-points for policy suggestions coupled with mobile devices with wireless access would     potentially increase the usage of FRAX® tool.      Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2)     To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis     diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions.      Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search     Pubmed and international osteoporosis guidelines to better understand the clinical     applications of FRAX® in other countries. Investigators will also search epidemiological data     for osteoporosis, facture, quality of life and cost to establish domestic cost-effeteness,     and translational approach FRAX® cut-points. 2) Three targeting populations from National     Taiwan University Hospital (NTUH) are selected for prospective study (Group A: geriatric     health exam clinics with American cut-points, group B: orthopedic clinics with translational     approach cut-points and group C: endocrine clinics with cost-effectiveness cut-points,). A     mobile device with app application coupled with the FRAX® tool is used by a trained research     assistant during clinic waiting periods to screen and enroll high risk (75 from each clinic)     adults with informed consents. Participants are referred to geriatric clinics for systemic     osteoporosis diagnoses and managements. Percentage of participants that meet the current NHI     medication reimbursement regulation and percentage of self-pay medications are calculated.     Analysis is stratified by age and gender. 3) The impacts of 3 different cut-points on     increment NHI reimbursement are estimated. An osteoporosis expert group meeting is to be held     for FRAX® based osteoporosis medication reimbursement modifications to the NHI and the     Department of Health.      Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis     screening and management model. 2) Base on the study results and expert consensus,     investigators will provide policy suggestions of FRAX® based reimbursement modifications.   "
103555|NCT01930643|"     Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure     would depend on ventilator support more than 14 days because of critical-illness weakness and     their underlying diseases such as heart failure and chronic obstructive pulmonary disease.      Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten     their ventilator days.      Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14     days are eligible. EMS would be applied in experimental group 32 minutes/day on their     bilateral thigh.   "
103591|NCT01930175|"     To evaluate the safety, tolerability and efficacy of a single intravneous infusion of VAY736,     compared to placebo, in pemphigus vulgaris patients.   "
103556|NCT01930630|"     By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be     separate from the adjacent organs.The space between esophagus and adjacent organs can be     detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to     be differentiate between T3 and T4 stage esophageal squamous cell carcinoma (ESCC). The     objective of this Phase Ⅰstudy is to confirm the safety and efficacy of ESI.   "
103655|NCT01929343|"     We propose that the systemic administration of lidocaine following the induction of     cue-induced craving, relative to saline plus cue-induced craving or lidocaine without     cue-induced craving, will block the reconsolidation of cue memories. This will lead to a     reduction in cue-induced craving upon repeated testing as well as subsequent cocaine use and     basal craving.   "
103557|NCT01930617|"     There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is     still differing considerably between departments. Except for a recent randomized controlled     trial (RCT) that found that postoperative subdural drainage was better than no drain, there     is no higher level evidence. Another recent RCT did not replicate these findings, but the     study was severely underpowered.      Aim of this population based study is to compare clinical results (reoperation rates,     complications, perioperative death, and survival) between neurosurgical departments treating     CSDH with different treatment policies.   "
103558|NCT01930604|"     Hyperhidrosis is defined as excessive sweating and affects about 2.8 % of the population.      It has been shown to have a deleterious effect on the quality of life measured using the     Dermatology Life Quality Index (DLQI) which is one of the most widely used     dermatology-specific quality of life instruments. This is comparable to the effect on quality     of life in patients with severe psoriasis of the skin as well as to nodulocystic acne     patients before treatment with oral isotretinoin.      The clinical effect of Botulinum Toxin (Btx) A has been established in three randomized     controlled trials (RCT) in axillary hyperhidrosis. One RCT has indicated a positive effect in     palmar hyperhidrosis. Although there is increasing evidence that Btx A and B have a similar     effect on hyperhidrosis of other parts of the body (ie hyperhidrosis of the face, trunk,     groin and feet) which is reported in case-reports and open studies there is still a great     need for more controlled studies. This is why we will carry out this randomized,     double-blind, placebo-controlled study to investigate the clinical effect and safety of Btx A     in palmar, plantar and inguinal (groins/buttocks) hyperhidrosis and the clinical effect and     safety of Btx B in craniofacial and truncal hyperhidrosis, respectively. Besides using the     DLQI instrument we will also study Btx A/B to elucidate the impact of this treatment on     quality of life using a generic instrument, the effect on anxiety and depressive symptoms,     sweating, and patients´global assessment of therapy.   "
103559|NCT01930591|"     Ticagrelor is a first line therapy along with aspirin for patients undergoing primary PCI for     STEMI. However, many patients are still treated with fibrinolytic therapy and the safety and     efficacy of Ticagrelor has not been investigated in this patients population. The present     study is proposed to study the safety and efficacy of Ticagrelor in patients undergoing PCI     post fibrinolytic therapy for STEMI.   "
103560|NCT01930578|"     The objective of the study is to identify a pattern of bioimpedance in humans during acute     food changes. As a part of this study the investigators will be administering sodium bromide     in oder to measure extracellular water via the bromide dilution technique.   "
103561|NCT01930565|"     In an 8 week double blind randomized controlled split-face studies, we tried to compare the     clinical efficacy, safety and histopathological changes between Lactobacillus fermented     Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)      Basically, this is a split face study - one side of face randomly assigned was applied with     LFCO and the other side with TTO in same patients.   "
103562|NCT01930552|"     Primary Objective:      To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV)     aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil,     and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.      Secondary Objectives:        -  To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus          aflibercept in patients with measurable disease (RECIST 1.1).        -  To evaluate the immunogenicity of IV aflibercept.   "
103563|NCT01930539|"     This is a randomized, controlled, unblinded pilot study for patients with vitamin D     deficiency in Intestinal Rehabilitation clinic. These patients are not able to absorb oral     vitamin D efficiently and thus have a high prevalence of vitamin D deficiency, leading to low     bone density.      The investigators will use FDA approved portable Ultraviolet B lamp for the intervention     group, 70 patients will be recruited from October 2013 to end of January 2014 and study     period is 12 weeks for each patient. Study completion will be end of April 2014.      Study hypothesis: Ultraviolet B light with a portable UV device will increase Total 25     hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.   "
103564|NCT01930526|"     Pulmonary rehabilitation (PR) with supervised exercise training is a key part of care for     patients with chronic lung disease (COPD). Patients can improve their shortness of breath,     walking distance and quality of life. However, many patients do not improve their overall     fitness. They are too breathless to train at a high enough intensity. In a laboratory     training study, patients with COPD improved their overall fitness by using single leg     cycling. Despite this knowledge, single leg cycling has not been used clinically. The     objective of this project is to use and assess single leg cycling in a clinical setting.     Single leg cycling can be incorporated into a clinical service (replacing traditional two     legged cycling) as the predominant aerobic training strategy, resulting in improvements in     cardio-respiratory fitness (peak oxygen uptake).   "
103565|NCT01930513|"     Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea,     OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early     death from heart problems. They are also associated with lower levels of physical activity.     Exercise strategies for weight loss, increasing physical activity and improving fitness are     needed for obesity. In Obese individuals with OSA        1. The investigators will compare corridor walking tests compared to laboratory exercise          tests. The null hypothesis is that the peak oxygen uptake achieved and the          cardiopulmonary response during both the six-minute walk test and Incremental Shuttle          Walk Test would not be different from that observed during an Incremental Treadmill          Test.        2. The investigators will investigate whether cycling or walking uses more calories for the          same intensity. We hypothesise that cycling (weight supported) will be endured for long.        3. The investigators will compare commonly used exercise tests with levels of daily          physical activity.      The information from these three projects will help us set up the optimal exercise program     for obese individuals.   "
103656|NCT01929330|"     The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules     compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this     study are expected to support registration applications for androgenetic alopecia (AGA) in     Japan and other international markets.   "
104570|NCT01917409|"     The purpose of this study is to compare conventional laryngoscopy with video-stylet     (Trachway) for nasotracheal intubation in patients undergoing oro-maxillo-facial surgery.   "
103566|NCT01930500|"     The purpose of this study is to determine whether individual and/ group based     neuropsychological rehabilitation focused on psychoeducation and teaching compensatory     strategies has positive effects on the psychosocial wellbeing and perceived cognitive     deficits in dyslexic young adults. The hypothesis is that both individual and group based     neuropsychological rehabilitation show positive effects on the psychosocial wellbeing and     perceived cognitive deficits. Another purpose of this study is to evaluate weather individual     and group based neuropsychological rehabilitation have different kind of effects on the     wellbeing of the participants and weather either one of the rehabilitation formats is more     effective than the other.   "
103567|NCT01930487|"     The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular     blood flow in a randomized double-blind, crossover design.      Based upon preliminary data, it is hypothesized that a dietary supplement containing a     variety of ingredients with antioxidant properties will, compared to placebo, increase ocular     perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain     these effects over the course of the treatment period.   "
103568|NCT01930474|"     The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR     and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in     patients with non-small cell lung cancers. Therefore, the detection of altered genetic     alterations is useful for predicting the treatment response for TKIs in non-small cell lung     cancer patients. However, good quality tumor tissues are available only in <50% of patients     with inoperable lung cancer for mutation analysis. In this study, the investigators will     detect and quantify the genetic alterations in plasma. the investigators will investigate if     the serial measurement of cancer-derived genetic alterations in plasma can provide a means     for monitoring disease progression, as well as treatment response. In addition the     investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma     tumor DNA.   "
103569|NCT01930461|"     The purpose of this study is to investigate the efficacy and safety of different doses of     sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with     house dust mite-associated allergic asthma.   "
103570|NCT01930448|"     Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can     result in significant weight loss and significantly improve type 2 diabetes in 40-80% of     cases. The mechanism and time course of these changes have not been well studied and are     poorly understood. The primary aim of this study is to investigate the potential     weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB     subjects after similar weight loss.   "
103571|NCT01930435|"     This is a single arm study of the use of a personalized sterile humidification device for 12     weeks for head and neck cancer patients undergoing radiation therapy to determine if the     usage of this humidification system will result in a decrease in severity in head and neck     related quality of life as measured by the MDASI HN subscale following radiation therapy as     compared with historical experience. In addition, we are exploring correlative measures using     CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to mucositis     and presumably related to quality of life as indicated by the patient.   "
103572|NCT01930422|"     The primary purpose of the protocol is to evaluate the effect of repeated application for 5     consecutive days of a real tDCS compared to the application of a placebo tDCS (sham     procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.      The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on     the left dorsolateral prefrontal cortex region will reduce the craving induced causing a     decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final     visit between Day 15 and Day 20.   "
103573|NCT01930409|"     The purpose of this study is to determine whether is is feasible and acceptable to deliver a     telephone based coaching intervention compared with education alone in community dwelling     older adults (age 60 and older) after a fall related hip fracture.   "
103574|NCT01930396|"     The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness     (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in     hemodialysis patients.   "
103575|NCT01930383|"     To explore the clinical value of circulating tumor cells (CTCs) measurement for     Hepatocellular carcinoma (HCC) patients.   "
103576|NCT01930370|"     Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard     concentration has been suggested in facilitating the removal of phosphate and potassium. To     test this hypothesis, the study will use a cross-over study design to evaluate phosphate and     potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid     (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the     effects of the different dialysate bicarbonate concentrations on the removal of phosphate and     potassium during hemodialysis   "
103577|NCT01930357|"     The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure     regimen in healthy children and adolescents aged 2 to 17 years.      Primary Objectives:        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of          subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international          units (IU)/mL at D42, i.e. 14 days after the last vaccination.        -  To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a          lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.      Secondary Objectives:        -  To assess the clinical safety of each vaccine after each vaccine injection when          administered in a pre-exposure schedule.        -  To describe the immune response induced by each vaccine 14 days after the last          vaccination, i.e. at D42, and 6 months after the first vaccination        -  To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e.          14 days after the last vaccination.   "
103592|NCT01930162|"     This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as     measured by the absence of graft failure at day 42 in excess of that currently observed with     double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA)     conditioning.   "
103639|NCT01929551|"     The purpose of this study is to compare the glycemic index of a beverage made of natural     concentrated mango puree with natural concentrated pear juice with other five different     products based on natural mango and pear ingredients in the form of fruit or juice against a     control of 50-gram glucose load.   "
103578|NCT01930344|"     During laparoscopic surgery, your surgeon operates through 'keyhole' incisions in your     abdomen. These allow long tools and a camera to pass to perform the surgery and allow the     surgeon to see inside you. The cameras images are seen on a television screen, and this is     viewed, like you watch television at home, in a two-dimensional (2D), form. This can make     performing laparoscopic surgery very challenging, as you have to learn to appreciate depth     while performing surgical tasks. Recent advances in viewing technology mean we now have the     capability for comfortable three-dimensional (3D) viewing of laparoscopic surgery, and many     centers have shown its superiority over 2D in lab-based experiments. However, this technology     has never been compared against our normal gold standard 2D imaging in laparoscopic     operations. This study aims to investigate whether there is a quantifiable benefit in using     these new 3D imaging systems over 2D for laparoscopy, as we hypothesise that there is a     marked benefit using 3D over 2D. Patients who have been placed on the waiting list for     keyhole surgery to remove their gallbladder will be invited to take part in the study. If     they agree, they will undergo the standard operation for removing their gallbladder as     planned already. At the beginning of the operation they will be randomised (selected by     chance) into one of two groups. One group will have their surgery performed to our current     'Gold standard' with the surgeon using a 2D camera and screen. The other group will have the     exact same operation but with the surgeon using a 3D camera and screen. The intra-abdominal     part of the operation will be recorded and viewed by an independent observer who is a     surgeon, to assess for technical performance differences between operations performed in 2D     and 3D, as well as time taken for the surgery. There are no extra risks to taking part and     being randomised to the 3D group. The laparoscopic camera is the same size as a 2D camera and     used in the same way. There are no real disadvantages, as patients will still undergo the     operation they were booked for and will experience no change in their treatment. The aim is     to compare 2D and 3D Day Case Laparoscopic Cholecystectomies, to see if there is a marked     difference with this new technology. Lab based studies imply that 3D imaging systems reduce     surgical errors and operating time therefore could improve patient safety. This study may     help improve laparoscopic surgery for future patients.   "
103579|NCT01930331|"     Phase IV, single center, 2 arms randomized controlled, open label study. Study will be     conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics     and efficacy of ARCO.   "
103580|NCT01930318|"     It is well established that the resistance to the effects of insulin on glucose metabolism     develops with a lot of stress hormone release after surgical trauma. This condition is known     as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic     acidosis. Surgical IR not only affect glucose metabolism but also influence protein     synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.      Postoperative pain is a challenging task for patients and surgeons, and it is part of the     stress response to trauma and surgery, while the fear of pain can exacerbate the stress     response.      The main aim of this study was to invest whether effective postoperative analgesia can reduce     the stress response and insulin resistance.   "
103581|NCT01930305|"     To inversitage whether routine warming of blood is harmful to brain fuction of sugical     patients receiving massive transfusion.   "
103582|NCT01930292|"     This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC),     platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast     cancer (TNBC).      The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio     1143 when administered to these patients in combination with full doses of paclitaxel and     carboplatin.      The primary objective of Part B is to consolidate the safety profile of the recommended dose     of Debio 1143 when administered to these patients in combination with full doses of     paclitaxel and carboplatin.   "
103583|NCT01930279|"     Sleep deprivation was found to affect many organs including the immune system and     predisposing for various health consequences including diabetes hypertension infections and     increase in neoplastic diseases.      Subjects will be evaluated for immune parameters in peripheral blood test following a regular     nigh sleep and compared with a test performed following a night shift in which they slept     less than 3 hours.      Each participant will serve as its own control.   "
103584|NCT01930266|"     Diet is the only source for calcium and the most important dietary source are dairy products.     This presents a difficulty for children with IgE-mediated cow's milk allergy, who are unable     to consume milk. We noted that IgE-CMA allergic young adults have a significant decrease in     bone mineral density (BMD) compared to international reference values and also to     geographically and age matched normal controls.      Working hypothesis: Young adults with IgE-CMA have significantly lower BMD than age and     gender matched controls. This can be reversed by introducing dairy products following     recovery from allergy, or by enriching the diet via other calcium sources.   "
103585|NCT01930253|"     Autoimmune cytopenias are a significant complication observed after hematopoietic cell     transplant (HCT) and carries a substantial rate of morbidity and mortality. This entity is     usually challenging to treat, resulting in prolonged hospitalization and predisposes patients     to complications either directly due to the specific cytopenia or due to the immune     suppression that is part of its therapeutic management. One of the mediators of refractory     autoimmune cytopenias are antibodies produced by plasma cells, which are historically     challenging to target. The purpose of this study is to use a proteasome inhibitor called     Bortezomib for the treatment of refractory autoimmune cytopenias after HCT, and monitor the     clinical response.      This is a pilot study which will enroll 5 patients over 2 years, prospectively. Our     hypothesis is that bortezomib will effectively target plasma cells and successfully treat     refractory autoimmune cytopenias. This will be a relevant study as it will be the first step     in establishing a novel therapeutic modality and potentially reducing length of     hospitalization and degree of immune suppression for refractory autoimmune cytopenias.   "
103586|NCT01930240|"     The primary objective of the study is to assess the blood profile of the N-methylnicotinamide     (MNA) following administration of TRIA-662 (N-methylnicotinamide Chloride). The secondary     objectives of the study are to characterize the safety and tolerability of TRIA-662 and to     assess any potential gender-related differences in the plasma profile of MNA. Changes in     serum lipid parameters with particular reference to triglycerides, lipoprotein lipase, and     blood pressure effects will also be noted.   "
103587|NCT01930227|"     The purpose of this study is to compare the effect of TEAS on hypotension after spinal     anesthesia in patients undergoing cesarean section   "
103589|NCT01930201|"     This retrospective chart review will demonstrate the feasibility of performing caudal     epidural blockade in adolescents undergoing major orthopedic hip surgery and provide     information regarding the feasibility of this technique's use on a regular basis.   "
103590|NCT01930188|"     This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to     evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as     add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.   "
104571|NCT01917396|"     The researchers investigate that use of preoperative enema to the effect postoperative bowel     gas passage.   "
103593|NCT01930149|"     Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk     assessment. Cholesterol screening is recommended by the United States Preventive Services     Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of     preventive services, including in safety net settings, we will implement patient-directed     reminders to health center patients who meet our eligibility criteria.      The aim of this study is to determine if a mailed outreach message and facilitated ordering     of screening lipid tests increases cholesterol screening test completion within 3 months     among federally qualified community health center patients who are eligible for screening     compared to usual care.   "
103594|NCT01930136|"     The study investigates whether a long-term 25% caloric restriction can prevent onset and/or     progression of renal function deterioration, retinal involvement and cardiovascular     complications in overweight/obese type 2 diabetic patients, trough the amelioration of     concomitant metabolic abnormalities such as visceral obesity, insulin resistance,     dyslipidemia, hypertension and inflammation.      The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on     subjects at risk of nephropathy. Secondary aims are to better understand the relationship     between CR and the following aspects: renal disease and its associated metabolic     abnormalities, retinopathy and cardiovascular complications, quality of life and treatment     cost.   "
103595|NCT01930123|"     This study will advance several goals of the NIH Action Plan: 1) establish a     multidisciplinary team to develop quantitative methodologies and imaging protocols for liver,     2) validate diagnostic criteria and methodologies for imaging in liver in both a     cross-sectional and a longitudinal dietary intervention study of patients with NAFLD, 3)     create a liver tissue bank with correlative imaging data, 4) develop reliable non-invasive MR     markers to distinguish simple steatosis from NASH, and 5) define the dynamic changes in     metabolism, energy homeostasis, and MR biomarkers as they relate to fructose-related liver     injury.   "
103596|NCT01930110|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would     regulate glucose levels through the infusion of two hormones: insulin and glucagon.      The objective is to compare the efficacy of single-hormone closed-loop strategy and     dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and     interval exercise.      The investigator hypothesized that dual-hormone closed-loop strategy is superior to     single-hormone closed-loop strategy in regulating glucose levels during exercise periods.   "
103597|NCT01930097|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would     regulate glucose levels through the infusion of two hormones: insulin and glucagon.      The objective of this project is to assess whether a dual-hormone closed-loop strategy would     alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D)     without a significant degradation in post-meal glucose control.      Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is     equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during     closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that     closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or     meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than     conventional pump treatment in regulation of glucose levels in adults with T1D.   "
103598|NCT01930084|"     Purpose: To compare the effectiveness of a combination intervention strategy (CIS),     consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and     accelerated ART initiation for eligible participants delivered by facility personnel, and     cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on     linkage to and retention in HIV care at 12 months among adults testing positive for HIV in     Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+     non-cash financial incentives (FI) compared to CIS without FI on study outcomes.   "
103599|NCT01930071|"     To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass     Guidewire Delivery System and commercially available stent grafts.   "
103600|NCT01930058|"     This adaptive design study will evaluate the safety, pharmacokinetics, and effect on     hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV     infection. The study will consist of 4 parts evaluating participants infected with specific     hepatitis C virus genotypes and up to 10 panels allowing for additional participants to     enroll in each panel as specified in the study analysis. The hypothesis evaluated in the     study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple     dose administration of MK-8876 in participants with HCV infection.   "
103601|NCT01930045|"     This study evaluated the effect of single doses of a magnesium/aluminum antacid (MAALOX)     given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics of     raltegravir in human immunodeficiency virus (HIV)-infected participants. The study consisted     of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5), with each study period     separated by a washout period of at least 2 days; Part 1 was separated from Part 2 by a     Pause. Each study period had a duration of ≥2 days, and paused for evaluation of Part 1     pharmacokinetics results before continuing to Part 2. The same participants participated in     Parts 1 and 2. The primary hypothesis tested (in Part 1) was that raltegravir plasma     concentration 12 hours after administration (C 12 hrs) would not differ significantly from     raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after     raltegravir.   "
103602|NCT01930032|"     The purpose of this study is to learn more about infection by Clostridium difficile (also     known as C. difficile). C. difficile is a common bacterium (a germ that may cause disease)     that can live in the human gut. Some people have it without having any symptoms. In other     people it can cause illness ranging from mild diarrhea to severe colitis (infection of the     colon).      C. difficile makes toxins that damage the cells that line the colon. The study doctors want     to find out how these toxins cause damage to the cells in the colon.   "
104512|NCT01918163|"     Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of     concentration, motility and morphology, as well as in fertilization rate.      Minor data is available regarding the influence on male sperm.   "
103603|NCT01930019|"     The effect of etomidate administration on the adrenal cortex in obese patients is still     unclear. The objective of the study was to determine the influence of single dose of     etomidate on cortisol secretion in morbidly obese. The participants were divided equally into     etomidate and thiopental groups, depending on kind of intravenous anesthetic used for     induction of anesthesia.      Healthy patients in ASA class I and II awaiting elective abdominal laparoscopic surgery were     included in the study. The participants were initially divided into two groups: the first     group included patients with morbid obesity (BMI > 40), and the second group included     patients with normal body weight (BMI < 25). All the patients inside the two groups were     subsequently randomly and divided into etomidate and thiopental groups, according to the     intravenous anesthetic used as the induction agent for general anesthesia. Finally, four     groups of patients were analyzed: 1. obese, in which etomidate was used (OE group), 2. obese,     in which thiopental was used (OT group), 3. patients with normal body mass, in which     etomidate was used (NE group), and 4. patients with normal body mass, in which thiopental was     used (NT group).      The patients excluded from the study were those who: 1. did not agree to participate, 2. were     treated with steroidal drugs, 3. had cortisol metabolism disorders or were treated with drugs     with a potential impact on serum cortisol concentration, 4. had a preoperative risk     assessment result of ASA class III, IV and V, 5. had an initial surgical laparoscopic     technique converted to laparotomy, and 6. had surgical complications increasing the level of     intraoperative stress.   "
103604|NCT01930006|"     In this study two MGCD265 oral formulations at dose level of 100 mg are administered to     healthy male and female subjects under fasting conditions.   "
103605|NCT01929993|"     The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone     (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in     reducing the incomplete excision of disease.   "
103606|NCT01929980|"     The purpose of this trial is to study the safety and effectiveness of a drug called     Bortezomib for the treatment of low blood cell counts after bone marrow transplant.   "
103607|NCT01929967|"     The investigators aim with this study is to investigate the mechanisms of immune deficiency     in patients with heterotaxy syndrome through the use of novel biomarkers and a prospective     questionnaire survey documenting the burden of infectious sequelae following enrollment. It     is known that patients with under-active spleens (functional asplenia or hyposplenia)     secondary to other (non-cardiac) conditions such as Sickle Cell Disease or Inflammatory Bowel     Disease have a characteristic paucity of a B cell sub-class known as IgM memory B cell. This     specific sub-class of B cell normally matures in the spleen and in those with an improperly     functioning spleen a significant deficiency of this B cell class is seen on flow cytometry.      Similarly, these same patients are noted to have increased amounts of 'junk' DNA / nuclear     remnant in their red cells. This is seen on microscopy as a dark particle inside the red cell     and is termed a Howell Jolly Body (normally less than 2% of red cells have these dark     particles present). Part of a functioning spleen's normal task is to rid the blood of red     cells that contain nuclear remnants and an under-active spleen gets behind on this task with     a build-up of Howell Jolly Bodies in red cells present in the bloodstream. Flow cytometry can     very quickly and accurately quantify Howell Jolly Bodies as well as IgM memory B cells from a     small (~1.5cc) sample of blood. Normal IgM memory B cell ranges are known for healthy     children from infancy onwards allowing interpretation of results against normative data     ranges.      The investigators aim to enroll 10 patients in this pilot study who have a diagnosis of     heterotaxy syndrome (both asplenia and polysplenia) and to prospectively follow them after     obtaining the initial biomarker sample. The family will be contacted once every two weeks for     a period of 12 weeks and asked a series of simple questions taking approximately 5 minutes on     any recent infectious sequelae or symptoms. The questions will elucidate history of minor     illness such as low-grade fever or cough to more significant events such as admission for     in-patient antibiotic therapy of bacterial sepsis. Ultimately, with this pilot study, the     investigators hope to obtain sufficient data to support funding applications for a larger,     multi-center trial that will allow us to develop biomarker thresholds for future risk of     sepsis.   "
103608|NCT01929954|"     This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the     safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring     extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT     and Bio-Gide).   "
103609|NCT01929941|"     This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1     and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety,     tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose     of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of     patients with solid tumors. Each patient group will participate in a phase of the study which     is divided into two parts. The patient groups will be enrolled in a sequential manner     starting with Patient Group 1.      Patient Group 1      Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986     as monotherapy.      Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and     pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced     malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of     INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial     pharmacologic effect. These doses will be used in Part 2 of the study.      Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and     preliminary clinical activity of INCB047986 using the doses identified in Part 1.      Group 2      Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or     urothelial cancer.      Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in     combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic solid     tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or second     line), triple-negative breast cancer (second line) or urothelial cancer (second line).      Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers,     and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients     enrolled in this phase will be limited to those with advanced or metastatic pancreatic     cancer.   "
103610|NCT01929928|"     The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection     system.   "
103611|NCT01929915|"     Long-term survival for patients with pancreatic carcinoma is low, even following resection,     the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to     local recurrence, distant metastasis or both within one to two years after surgery2-4.      Surgery has been suggested to accelerate the development of preexisting micro metastases and     to promote the establishment of new metastases5. Release of catecholamine and proinflammatory     products secondary to surgical stress is believed to promote cancer progression6. Maintenance     of proper anesthetic depth is beneficial to attenuate surgical stress. However, general     anesthesia including numerous induction agents, volatile anesthetics and opioids, is     associated with immunosuppression especially on the cell-mediated immunity which has a     crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and     analgesia which effectively attenuating surgical stress while efficiently reducing general     anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer     progression. Currently, most studies available in humans are retrospective and observational     to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related     outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is     available13. However, it is not specific to an individual cancer type and perioperative     cell-mediated immunity is not evaluated.      In this study, we aimed to identify whether epidural block beneficial to early surgical and     late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative     cell-mediated immunity functions including natural killer cells, helper and cytotoxic     T-lymphocytes were also investigated.   "
103612|NCT01929902|"     The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.   "
103615|NCT01929863|"     Metformin may have complex interactions in the gut and is generally first line therapy for     type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant     pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with     metformin in subjects with T2DM. The purpose of this study is to investigate the safety and     tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin.     This will be a two-period crossover study; subjects will receive either GSK2330672 or placebo     for 7 days in each period separated by a washout period of 13 to 15 days. All subjects will     receive metformin throughout the study   "
103616|NCT01929850|"     Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defines as     greater than 100 pounds overweight and/or greater than 200 % of ideal body weight. Chronic     underemployment, poor housing, child abuse, limited education, stress and anxiety are all     associated with maternal morbid obesity. These latter conditions leave many patients in a     state of economic, social and emotional poverty with need for life-long welfare support. For     patients with true morbid obesity a standard surgical procedure is currently the procedure of     choice especially among patients who fail standard medical intervention. The major procedures     performed for morbid obesity include the Roux-en-Y gastric bypass, sleeve gastrectomy and     laparoscopic band procedure. The sleeve gastrectomy is purely a restrictive procedure without     malabsorptive components which involves one single staple line and can be performed     laparoscopically in less than one hour. While these surgical procedures are recognized as     standard procedures for patient who have failed medical treatment and are covered by most     health plans, access to these procedures is limited for the medically underserved, rural,     poor or underrepresented minorities since national, state and municipal health plans either     provide minimal coverage or no coverage at all for surgery for morbid obesity. Reimbursement     to providers offering these procedures is minimal and thus access to bariatric surgery is     unlikely within a timely fashion.   "
103617|NCT01929837|"     Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus     affects approximately 10-15 % of the population. The prevalence increases with age and it is     estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of     tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety,     depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most     therapies focus on alleviating the condition rather than treating the cause. Pathophysiology     of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus     patients and animal models suggest that tinnitus is associated with increased neuronal     activity, increased synchronicity, and functional reorganization within the auditory cortex     either uni- or bilaterally, but there are also functional alterations in brain areas outside     the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique     based on the principle of electromagnetic induction of an electric field in the brain by     means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method     for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been     shown to decrease cortical excitability both in experimental settings and humans, which forms     the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom     hyperactivity of the auditory cortex has been observed in functional brain imaging studies   "
103618|NCT01929824|"     This study is aimed at understanding whether oral nitric oxide levels can be used as a     non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis     (EoE).   "
103619|NCT01929811|"     To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in     neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can     increase the pCR rate combination with TEC regimen in neoadjuvant setting.   "
103620|NCT01929798|"     The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device     using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1     diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to     compare closed-loop control with or without optimization of initialization parameters related     to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and     snacks.   "
103621|NCT01929785|"     This is a single center observational study. Duration of the study is 1 year. Participants     will be followed in 2 groups. Group 1 will include all patients who have undergone a heart     transplant, through the first year post transplant. Group 2 will include heart transplant     recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It     is anticipated each group will have 25 participants.   "
103622|NCT01929772|"     The aim of this study is to investigate if there is a correlation between lactate clearance     and the course at patients with severe sepsis and septic shock at german intensive care     units.   "
103623|NCT01929759|"     In this study we will use a multi-modal imaging approach of MRS and fMRI to comprehensively     assess the biological changes in the brain associated with EFV-based regimen (EFV/FTC/TDF),     specifically alterations in the brain circuitry, function and local neurochemistry, and their     correlation with neuropsychological function. In a cohort of HIV-infected patients who are     clinically stable on the commonly use regimen of EFV/emtricitabine (FTC)/truvada (TDF) or     Atripla, we propose to replace the EFV component with a new integrase inhibitor, elvitegravir     (EVG) boosted with cobicistat (COBI), given as the EVG/COBI/FTC/TDF Single Tablet Regimen     (STR) to evaluate the EFV-related neural alterations. This is a multidisciplinary study which     involves a team of infectious disease experts in the field of HIV, neuroradiologists with     expertise in fMRI and MRS techniques to study various central nervous system and psychiatric     disorders and a psychiatrist with experience and expertise in research on abnormalities of     affective and motivational processing in the context of neuropsychiatric disorders. We will     utilize the established clinical research platform in the Infectious Disease outpatient     clinical practice at the Brigham and Women's Hospital, where there is currently have many     ongoing HIV-related studies and a large panel of HIV-infected patients motivated to be     involved in clinically relevant research. We propose to use advanced neuroimaging to measure     biologically changes in the brain associated with long-term EFV use with the following     specific aims:        1. Determine changes in neurometabolites measured by MRS in the brain associated with          long-term EFV use        2. Assess for alterations in neural activity correlated with affective symptoms associated          with EFV vs STR use using fMRI, and their associations with changes in neurometabolites          assessed by MRS, and with changes in cognition assessed by Trail Making and Digit          Substitution Tests.        3. Determine changes in emotion, cognition and sleep quality after switching from EFV to          STR, and how they correlate with subject treatment preference.      This clinical study will extend our current understanding of EFV neurotoxicity by further     defining the nature of these biological changes. Further elucidation of the neurobiological     underpinnings of EFV-induced CNS toxicity will have clinical relevance in improving the     quality of life and drug adherence of HIV-infected patients on ART, especially among older     patients or those with baseline neuropsychiatric disorders, whom at baseline are more     vulnerable to neurocognitive decline from long-term HIV infection.   "
104535|NCT01917864|"     The purpose of this study is to evaluate the utility of a specialized iPad application     designed to treat difficulties with intonation (e.g., melody in voice) in children with     autism spectrum disorders (ASD) and other communication disorders.   "
103625|NCT01929733|"     Percutaneous closure is one of the methods used to treat, among other congenital heart     disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years     1998-2013 four hundred and fifty patients were catheterized in the department of pediatric     cardiology and congenital heart diseases in Rambam health care campus, using various devices.      In this retrospective research, the investigators analyze data from patients' medical files,     to estimate and define the correlation between the patients' demographic and morphologic data     to the type and size of chosen closure device.      Aim of study:      To create an algorithm that can be used to choose the proper device for percutaneous closure     of the PDA, based on the characteristics of the patient and the PDA type.   "
103626|NCT01929720|"     This randomized clinical trial studies a cognitive-behavioral intervention to treat worry,     uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as     well as improve the well-being and quality of life of cancer survivors. This study also     explores the neuro-immunologic correlates of anxiety and insomnia.   "
103627|NCT01929707|"     The main purpose of this study is to evaluate the safety and how well the body will handle a     single dose of increasing strength of study drug LY3050258. Each participant will receive     LY3050258 or placebo once, in each of two dosing periods. At least seven days will pass     between doses. This study will last approximately 45 days for each participant. Screening is     required within 28 days before the start of the study.   "
103628|NCT01929694|"     Consuming a guaraná and vitamin and mineral complex can improve mental fatigue and cognitive     function at rest; guaraná also contains caffeine, which can reduce perceived exertion and     increase fat burning during exercise. The purpose of this study is to test whether consuming     a guaraná and vitamin and mineral product before exercise influences affect (mood), physical     exertion and fat burning during exercise and mental fatigue, cognitive performance and affect     post-exercise.   "
103629|NCT01929681|"     Objectives:      To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation     (LFMS)in subjects with bipolar depression.      Hypotheses:      Investigators expect subjects who receive LFMS to show significant mood improvement one week     after the start of a three day course of daily stimulation as compared to subjects who     receive sham LFMS.      Investigators expect subjects who receive LFMS to show immediate mood improvement over the     first treatment as measured by the difference in pre and post-treatment PANAS+ ratings.      Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.   "
103630|NCT01929668|"     The purpose of this study is to compare preference of the patients, efficacy of preparation,     and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid     in patients with inactive ulcerative colitis.   "
103631|NCT01929655|"     To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese     patients with CRPC and bone metastases after a multiple administration   "
103632|NCT01929642|"     The purpose of this study is to assess the feasibility and safety of administering     rapalogues, sirolimus or everolimus, in participants with Tuberous Sclerosis Complex (TSC)     and self-injury and to measure cognitive and behavioral changes, including reduction in     autistic symptoms, self-injurious and aggressive behaviors, as well as improvements in     cognition across multiple domains of cognitive function.   "
103633|NCT01929629|"     The purpose of this study is to assess the safety and tolerability of orally administered     AZD0914 in healthy adult subjects.   "
103634|NCT01929616|"     The general objectives are to evaluate activity and the safety of regorafenib in a population     of patients bearing advanced, refractory colorectal cancers and to explore the different     downstream molecular pathways to identify tumor response and resistance mechanisms.   "
103635|NCT01929603|"     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the     effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow patients     continued access to olaparib after the PK phase and will provide additional safety data.   "
103636|NCT01929590|"     the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to     single (4 L) or split-dose (2 L + 2 L) treatments are not different.   "
103637|NCT01929577|"     The purpose of this study is to determine the relative bioavailability of ASP015K under     fasting conditions after single-dose administration between a test-tablet formulation and a     reference-tablet formulation. This study will also evaluate the food effect on     bioavailability of the test formulation, and evaluate the safety and tolerability after     single-dose administration of the test- and reference-tablet formulations.   "
103638|NCT01929564|"     The participants of this study will be men & women ≥50 years who are deemed to have a 10-30%     risk of developing CVD over the next 10 years. Their risk will be calculated using the Joint     British Societies 2 (JBS2) guidelines on the prevention of CVD in clinical practise     algorithm. This takes into account the participants age, sex, cholesterol values, blood     pressure,family history and their ethnicity (SE Asian or not). The participants will be     randomly assigned to one of two groups with the aid of a computer program called minim     which uses their age, sex, BMI and smoking status to determine which broccoli each     participant will consume on the intervention.      Each participant will consume 4 x 100g of their assigned broccoli, each week for 12 weeks on     top of their normal diet. They will be allowed to eat the broccoli whenever they want during     the week, but will be asked to note down when they eat it. A steamer will be provided so     participants can cook their broccoli for the required 4-5 minutes. Participants will be asked     to keep two diet diaries during their time on the intervention, one before they start the     intervention and one towards the end. Blood samples and urine will also be collected, pre and     post intervention, for the analysis of biomarkers of CVD.      This is joint project based at two sites, the Institute of Food (IFR) Research in Norwich and     the University of Reading(UoR), in Reading. Samples from the participants at both sites will     be analysed at IFR, UoR and companies in the United States.   "
103677|NCT01929057|"     The purpose of this study is to determine the response of acne patients and healthy control     patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants     to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1     to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for     further analysis in the lab to determine whether the inflammation in these pimples can be     reduced using anti-P.acnes antibodies.   "
103643|NCT01929499|"     It has been reported that the immune status of patients with cancer were suppressed,     especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease     the recurrence rate after surgery. CIK cells transfusion has been reported as an effect     therapy in advanced cancers. In another retrospective study, investigators found that     adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer     patients.      The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in     patients with colon cancer after operation will prolong DFS, and overall survival (OS).   "
103644|NCT01929486|"     The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T     cell depletion with Mogamulizumab for advanced or recurrent cancer patients.   "
103645|NCT01929473|"     Serum samples will be corrected twice from the same youth subjects with one year interval.      Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from     an identical individual.      The relationship between the incidence and the demographic data or medical history of the     subjects will be discussed.   "
103646|NCT01929460|"     Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst     aspiration is equally effective to the usual regimen of 3 days of post-procedural     antibiotics.   "
103647|NCT01929447|"     The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most     of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea     Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep     and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in     addition to the previous episodes also respiratory effort related arousal episodes. The high     cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led     to the development of a variety of ambulatory sleep study systems.      The primary objective of the study is to evaluate the newly developed WP200 with the unified     probe (WP200U) compared to the currently used configuration of WP200 that uses an     incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.   "
103648|NCT01929434|"     Cerebral palsy (CP) is described as a group of permanent disorders affecting motor     development and posture, resulting in activity limitation attributed to nonprogressive     disturbances of the fetal or infant brain. The prevalence of cerebral palsy has increased     among the children with low birth-weight, jaundice, respiratory distress and intrauterine     infection and so on. The incidence of cerebral palsy is increasing gradually with increased     neonatal survival rate. Although there are many kinds of functional therapy programs     especially the rehabilitation treatment for cerebral palsy, their effects are limited.     Increasing cerebral palsy patients become a heavy burden to the family and society. Stem cell     based therapy, a new prospective therapy for central nervous system disorders, has the     potential to repair the damaged brain tissue in patients with cerebral palsy.      In this study, 300 patients with cerebral palsy will be divided into three groups and the     investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 CP     patients of them randomly. We will also follow up the other 100 patients who only receive     rehabilitation treatment and another 100 patients who accept neither stem cell therapy nor     rehabilitation treatment. On this basis, as the investigators we can compare the efficacy of     cell therapy and rehabilitation treatments for cerebral palsy patients.      Multiple sources of assessment were used to ascertain and classify all cases of cerebral     palsy. Particularly the Gross Motor Function Measure (GMFM) as an important valid and     reliable outcome measure, has made it possible to evaluate the severity of movement     disability，change over time and the effects of clinical interventions. It also will be the     primary outcome measure in follow-up analysis of this study.   "
103649|NCT01929421|"     To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in     metastatic colorectal cancer   "
103650|NCT01929408|"     The purpose of this study is to compare treatment methods and outcomes of patients diagnosed     with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).   "
103651|NCT01929395|"     This is a 2 Phase study. In the first phase of the study, patients with palpable invasive     breast cancer underwent pre-operative supine MRI and optical scanning in the surgical     position. In the second phase of the study, patients with non-palpable invasive breast cancer     or DCIS who desire breast conservation will be randomized to either a usual care group, or a     group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI)     and undergoing breast cancer resection without the wire localization technique.   "
103652|NCT01929382|"     The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are     the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches,     and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy     volunteers as well as in patients.      This study is designed to determine whether a titration of dosing reduces the frequency and     severity of the FLS. A reported study with another interferon (interferon beta), demonstrated     a reduction in the frequency and severity of the FLS when a titration of dosing was used.     This study will compare the effects of the standard dose regimen with a titration regimen in     healthy volunteers.   "
103653|NCT01929369|"     This pilot study will provide data to aid in the planning of a follow-up multi-center     randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by     formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm)     was derived in consultation with the study PI and Co-PI who are experts in vascular surgery,     and in particular, the field of hemodialysis access interventions. The results of this pilot     study will provide the data that is necessary for generation of specific hypotheses that can     then be formally tested in the follow-up RCT   "
103654|NCT01929356|"     Primary ciliary dyskinesia (PCD) is a rare disease, caused by impairment of the motile cilia.     Patients present with chronic upper and lower respiratory tract infections. The therapy is     mainly supportive and based on that of cystic fibrosis. Chest physiotherapy is one of the     cornerstones of the therapy, however the influence of chest physiotherapy on lung function     (short term and long term) is not clear. For interpretation of longitudinal lung function     data it is important to examine the short time effect of chest physiotherapy. We hypothesize     that a session of chest physiotherapy improves lung function and that thus lung function     tests must be performed in a standardized way.   "
133907|NCT01532128|"     The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline     pharmacokinetics in healthy subjects.   "
103657|NCT01929317|"     This study is a Phase III, multicentre, randomized, initial double-blind study with     subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase     effect verification phase (12 weeks), a down titration 1 phase (1 week), a long-term phase     (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase. Subjects will be     assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance group at a ratio of     3:1. This study is being conducted to evaluate the efficacy (effect of increasing Ropinirole     dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in early and advanced PD     patients who have not achieved an optimal therapeutic response with marketed Ropinirole     Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day) formulations.   "
103658|NCT01929304|"     Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief     video education vignette to determine understanding and preferences among general emergency     department patients of rescue access techniques. A challenge of emergency care is providing     patient education surrounding procedures in a standardized and patient-oriented manner. This     data would provide insight on a patient's understanding of the risks and benefits of rescue     access, assess patient preference, and potentially influence what rescue technique is     employed in the future. This information may also give us insight onto why DIVA patients     might refuse randomization.   "
103659|NCT01929291|"     The purpose of this study is to collect safety information from pre-adolescents, adolescents     and adults after Boostrix vaccination is administered according to the approved prescribing     information in Korea.   "
103660|NCT01929278|"     Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that     contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified     vehicle. This was a single-center, evaluator-blinded, randomized, placebo     (vehicle)-controlled phase 1 study to evaluate the phototoxic potential of CT Gel using 24     hour single applications of 3 sets of 3 study patches. The study expected to enroll     approximately 40 healthy adult volunteers. Each set of study patches consisted of a CT Gel     patch, a vehicle gel patch, and a blank patch (did not contain CT Gel or vehicle gel).      After concurrent 24-hour single applications of all 9 patches, 1 set of patches (set A) was     removed, and those sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) and     0.75 minimal erythema dose (MED) with UVA/ultraviolet B light (UVB). The second set of     patches (set B) was removed, and those sites were irradiated with 16 joules/cm2 of UVA, 0.75     MED with UVB/UVA, followed by 15 joules/cm2 of visible light (VIS). The third set of patches     (set C) was then removed, and those sites served as a non irradiated control. Inflammatory     responses and other cutaneous effects were scored 1 hour after patch removal and during     follow-up visits at 24, 48, and 72 hours after patch removal.   "
103661|NCT01929265|"     This is a prospective, multicenter phase II trial designed to determine efficacy and safety     of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with     advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).   "
103662|NCT01929252|"     The aim of this study was to investigate the analgesic efficacy of dexmedetomidine     administration in wound infiltration for total abdominal hysterectomy.   "
103663|NCT01929239|"     This is a Phase Ib Pilot study of anti-PSMA designer T cells in metastatic prostate cancer.     Subjects will receive escalating doses of T cells, with either low or moderate dose     Interleukin 2. The T cells are collected by pheresis and then genetically modified, and given     in a one time infusion.   "
103664|NCT01929226|"     To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous     (IV) dose of ETI-204 in adult volunteers.   "
103665|NCT01929213|"     This study is designed to investigate the pharmacokinetic drug interaction and safety after     oral administration of Udenafil(DA-8159) and Bosentan in healthy volunteers.      Design: Randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence,     Williams design      Investigational Product: Udenafil, Bosentan   "
103666|NCT01929200|"     This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating     such patients. The primary endpoint is to compare the recurrence-free survival after 1-year     or 2-year treatment with icotinib.   "
103667|NCT01929187|"     Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection     affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and has     the potential to be a source of morbidity. Although oral antifungal agents achieve a better     complete cure rate for onychomycosis, many patients are worried about the side effects and     unwilling to take oral medications. Phytonail is a mixture of herbal active ingredients     including tea tree oil, lavender oil and Australian blue cypress oil with BioEqual carrier     system. A preliminary trial has shown a 100% KOH negative rate in 32 nails after 12 weeks of     Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine     antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials     for the treatment of toenail onychomycosis.      Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail     lacquer in the treatment of toenail onychomycosis.      Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with     toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1 ratio     to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before     randomization, patients are to have onychomycosis in at least one great toenail with positive     KOH examination and positive fungal culture. During the treatment phase, Phytonail will be     applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all affected     toenails. Physician's assessments and photographic analyses will be carried out at baseline,     Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be performed at     baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and for KOH     negative patients.   "
103678|NCT01929044|"     The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in     comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.   "
103679|NCT01929031|"     The primary objective of this study is to compare the efficacy of a combination product     containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as     placebo for the treatment of post-surgical dental pain over an eight-hour period followed by     a single dose of study medication (study stage 1). A secondary objective is to evaluate     efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day     post-surgical period (study stage 2).   "
103668|NCT01929174|"     The purpose of this protocol is to measure the relaxation of the heart in subjects with     single ventricles who have undergone the surgical Fontan procedure. We will do this by     measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to     blood levels that measure heart scarring. We will also measure relaxation before and after     boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid     in the heart. Measurements of heart relaxation will be obtained from the MRI, echocardiogram,     and cardiac catheterization for each patient and compared to blood markers of heart scarring.     We aim to compare all of these measurements to see if we can accurately identify heart     scarring and, if present, how much it correlates with impaired heart relaxation.   "
103669|NCT01929161|"     The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion     yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and     thereby increases nonconscious motives that shape daily behavioral decisions to repeat it,     which in turn foster positive emotions that further augment nonconscious motives in an upward     spiral dynamic.      The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e.,     moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion     yield of meditation, which varies by experimental condition, increases the nonconscious     incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict     positive emotions, sparking the relationships among OT manipulation, positive emotion yield,     and nonconscious incentive salience of Wellness Behavior-related cues.   "
103670|NCT01929148|"     We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH)     has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone     (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian     diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative     surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative     hospital stay, postoperative return to normal activity and complication rate) are related to     PBS step in TLH.      Although the good statistical reliability of our retrospective data, we want to prospectively     confirm our results. Moreover we aim to refine PBS safety demonstration by collecting also 3D     ultrasound parameters [AFC, ovarian volume (OV), Vascularization Index (VI), Flow Index (FI)     and Vascularization Flow Index (VFI)]. Hormonal and ultrasonographic parameters may possibly     be unified into a new diagnostic algorithm (already at an advanced stage of production in UMG     Department) able to estimate the ovarian function both in term of reproductive ability that     in term of distance from menopause.   "
103671|NCT01929135|"     Periodontal disease (PD) is an inflammatory, infectious and destructive condition of the     tissues surrounding the teeth. However, even if bacteria are required to initiate periodontal     disease, the immune response is responsible for most of the destruction of the periodontal     tissues. Statins may be used to control the immune response to periodontal pathogens, a     factor that has not yet been managed clinically and even less massively.      Recently it has been reported the pharmacological effectiveness of topically used statins.     For periodontal disease, at least four well conducted clinical trials have been published     using a topically statin formula for pocket irrigation in adult populations with chronic     periodontal disease, observing surprising clinical results in all of them (with clinical and     statistical significance) and no adverse reactions.      The purpose of the present study is asses the effectiveness of a medicated 2% atorvastatin     dentifrice, as complement to non-surgical conventional periodontal treatment. Clinical     examination will be made at the beginning and after one month of treatment.   "
103672|NCT01929122|"     The purpose of this study is to explore the effects of cooked navy bean powder or rice bran     consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy     adults.   "
103673|NCT01929109|"     The purpose of this study is to measure how much of the study drug, LY2409021, gets into the     blood stream and how long it takes the body to get rid of it when given to participants with     different levels of kidney function. There are five study groups. Each participant may only     enroll in one group. Participants in groups 1 through 4 may be healthy or may have mild,     moderate, or severe kidney disease. They will complete one study period lasting about 29     days. Study group 5 will enroll participants with kidney disease who are on dialysis. They     will complete two study periods which together last about 59 days. Screening is required     within 21 days prior to the start of the study for all participants.   "
103674|NCT01929096|"     1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection          versus Edaravone Injection for acute ischemic stroke patients;        2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.   "
103675|NCT01929083|"     Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia     (irregular heartbeat) known as torsades de pointes (TdP), which is associated with     prolongation of the corrected QT (QTc) interval on the electrocardiogram (ECG). Mechanisms     for this increased risk in women are not well-understood. QTc interval duration has been     shown to fluctuate throughout the phases of the menstrual cycle. Evidence indicates that the     QTc interval response to drugs that may cause TdP is greater during the menses and ovulation     phases of the menstrual cycle, during which serum progesterone concentrations are lowest, and     lesser during the luteal phase, during which serum progesterone concentrations are highest.     Additional evidence from our laboratory suggests that progesterone may be protective against     TdP. Specific Aim 1: Establish the influence of oral progesterone administration as a     preventive method by which to diminish the degree of drug-induced QT interval prolongation in     women. Working hypothesis: Oral progesterone administration effectively attenuates enhanced     drug-induced QT interval response in women. To test this hypothesis, progesterone or placebo     will be administered in a crossover fashion to women during the menses phase of the menstrual     cycle. QTc interval response to low-dose ibutilide, a drug known to lengthen the QT interval,     will be assessed. The primary endpoint will be individually-corrected QT interval (QTcI)     response to ibutilide, in the presence and absence of progesterone, which will be assessed     by: 1) Effect on maximum change in QTcI, and 2) Area under the QTcI interval-time curves     (AUEC). At the conclusion of this study, we will have established that oral progesterone     administration is a safe and effective method of attenuating drug-induced QT interval     prolongation.   "
103676|NCT01929070|"     The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin     and omega-3 coadministration and HCP1007 in healthy male volunteers.   "
103680|NCT01929018|"     The objective of this study is to examine the feasibility of using a collaborative-care,     home-based rehabilitation program to improve functional outcomes for people recovering from     lower limb amputation caused by vascular problems and/or diabetes complications. The primary     hypothesis is that the rehabilitation program will result in greater improvements in     performance-based and participant-reported measures of physical function, compared to     standard of care after outpatient rehabilitation.   "
103681|NCT01929005|"     The investigators propose an innovative new model of care in which patients identified to be     at high risk of hospitalization are offered care by a physician who will direct their care     both in the hospital and in clinic but is able to do so because they see patients only at     high risk of hospitalization. This allows these physicians to have a panel of patients that     is small enough that they can provide them with continuing ambulatory care but sick enough     for those physicians to have enough of their patients hospitalized at any time to justify     having the physician spend several hours each morning seeing those patients in the hospital,     making the model economically viable and clinically valuable for the patient. The     investigators estimate that each of the 5 physicians the investigators propose to establish     in this model will serve a panel of about 200 patients in steady state with an average of 10     days of expected hospitalization and $75,000 each in Medicare spending per year, totaling $75     million annually. The investigators estimate that a 1% reduction in costs for these patients     will be more than enough to cover the ongoing costs of the model the investigators propose;     this is because the investigators' program reorganizes care rather than adding new forms of     care.   "
103682|NCT01928992|"     The purpose of this pilot study is to provide credible performance estimate information in     order to properly plan, design, and power a larger clinical study.   "
103683|NCT01928979|"     Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical     baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with     nonvalvular AF or atrial flutter documented with LA/ LAA thrombi on transesophag-eal     echocardiography (TEE).      The study is a company-sponsored, global, multi-center, retrospective, non-interventional     study. Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and     had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012 will be     identified through screening and review of medical records and included in the registry.     Retrospective patient data will be collected from May 2nd, 2013 to May 2nd, 2014. The     observation of each patient will cover the period from the diagnosis of an LA/ LAA thrombus     until the end-of-treatment TEE following the 3-12 week SoC anticoagulation (AC) therapy. If     no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy, the observational     period will end at 12 weeks after diagnosis at the latest. If more than one TEE was performed     during treatment, the thrombus outcome will be collected from the last TEE performed within     12 weeks of treatment start.   "
103684|NCT01928966|"     The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per     day in the diet of women will alter dietary fatty acid intake or blood pressure.   "
103685|NCT01928953|"     This prospective hybrid longitudinal study was conducted in the United States (US), Canada,     the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive     understanding of the burden of opioid-induced constipation (OIC) in these countries, this     study used a combination of web-based, longitudinal patient survey, retrospective data     abstraction from medical records, and a prospective physician survey.      The primary objective of this study was to estimate the rate of inadequate response to     laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative     use ≥ four times per reference period), and inadequate response (defined as fewer than three     bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of     Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too     hard, straining to have a BM, feeling like you didn't finish a BM, and feeling like you had     to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately)     participants with OIC, by country and overall.      The secondary study objectives are as follows:        1. To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as use          of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was defined          as the use of at least two laxative agents, each used ≥ 4 times in the reference period;        2. To describe the baseline demographic and clinical characteristics, including prior          health status, comorbidities, constipation-related GI symptoms, and concomitant          medications of patients with OIC;        3. To describe drug utilization and self-management of OIC;        4. To describe the pre-index and post-index healthcare resource utilization and estimate          costs associated with the diagnosis, treatment, and general management of OIC (including          laxative use) and events attributed to OIC, including both direct and indirect costs;        5. To describe patient-reported impact of OIC on health-related quality of life,          productivity, and pain management;        6. To describe patient-reported treatment satisfaction with laxative use; and        7. To describe physician-reported awareness of OIC and symptoms and understanding of          patient-reported impact of OIC.   "
103686|NCT01928940|"     This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety,     tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and     GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I     part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).   "
103687|NCT01928927|"     The main goal of this study was to see if a drug called telmisartan would decrease fibrosis     (scarring) and inflammation (irritation) in people who are infected with HIV and doing well     on their HIV medications. The study was also done to see what effects telmisartan has on     other signs of disease and inflammation in the body, and to see whether people who have HIV     can take telmisartan safely and without side effects that make them want to stop the drug.     Telmisartan is FDA-approved for treating high blood pressure and decreasing the chance of     heart attacks and strokes in people over the age of 55 years of age who are at high risk for     these events.   "
103688|NCT01928914|"     This will be a randomized, single-blind, placebo controlled, parallel group study.     Approximately 260 subjects will be enrolled in five groups. This study is designed to compare     the effects of tafenoquine, administered as single dose as well as administered over three     consecutive days, on the changes in QT duration to those observed in subjects dosed with     either moxifloxacin or placebo.   "
103689|NCT01928901|"     Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary     clearance   "
103690|NCT01928888|"     The purpose of this study is to compare the efficacy and safety of a single oral     administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg     famotidine and a single oral administration of placebo (comparator without an active     substance) in treating the symptoms of acute heartburn episodes. The study is designed to     collect more efficacy data on Talcid® in patients using self-medication to relief the     symptoms of acute heartburn.   "
104721|NCT01915420|"     The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting     bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients     with complex de novo native coronary artery lesions in all-day clinical practice.   "
103691|NCT01928875|"     The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy     in adjunct to other clinical information decreases the occurrence rate of inadequate     anesthesia events, bradycardia and hypotension in comparison to standard clinical practice     during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy     and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood     pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).   "
103692|NCT01928862|"     To study the efficacy and safety of Prepopik™ in children aged 9 to 16 years for overall     colon cleansing in preparation of colonoscopy   "
103693|NCT01928849|"     The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the     prevention of chronic neuropathic and post-amputation pain, as well as to further define the     underlying inflammatory and epigenetic mechanisms that lead to the development of such     chronic pain.      HYPOTHESES AND QUESTIONS      Hypothesis 1: The use of oral valproic acid in combination with regional anesthesia in     surgical limb-injury patients will decrease the incidence of chronic nerve injury and     post-amputation pain.      Goal 1: In a blinded, randomized placebo-controlled, multi-center clinical trial,     investigators will determine if oral VPA added to regional anesthesia and standard     perioperative management will reduce the incidence of nerve injury and post-amputation pain     when compared with regional anesthesia alone.      Hypothesis 2: The transition from acute to chronic pain is mediated via epigenetic mechanisms     (differential DNA methylation) in genes involved in nociception.      Goal 2: Investigators will analyze the DNA methylation patterns of patients with different     types of neuropathic and post-amputation pain and determine if they are altered by VPA.   "
103694|NCT01928836|"     The purpose of this study is to verify clinical utility of a simple blood test comprising of     four protein- based markers for risk stratification of patients presenting symptoms related     to lung cancer.   "
103695|NCT01928823|"     Since decades, D-Cycloserine (DCS, drug class: Oxazolidinone) is proven to be an effective     antibiotic agent in the treatment of tuberculosis. Furthermore it takes action in the central     nervous system as an partial agonist on NMDA receptors. Because of glutamate mediated     neuronal long-term potentiation in long-term memory DCS has an augmenting effect on emotional     learning, as it occurs in exposure therapy of anxiety disorders. In this context we use DCS     in addition to exposure therapy as a part of cognitive behavioral therapy (CBT) in patients     suffering from agoraphobia with or without panic disorder. Thereby DCS is applicated oral as     a capsule of 50mg, on three consecutive therapy sessions.   "
103696|NCT01928810|"     Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive     behavioural therapy in patients with panic disorder and agoraphobia.   "
103697|NCT01928797|"     The purpose of the study is to learn more about how the heart works during cesarean delivery     under spinal anesthesia (medicines given in the spine that numb parts of your body to block     pain) in women. The investigators would like to find out if the information about the heart     can help in treating blood pressure changes that occur during the cesarean delivery. The     investigators would also like to find out if this information can help reduce the chances of     nausea and vomiting during the cesarean delivery.      The activity of the heart changes during spinal anesthesia and cesarean section. In the past,     a sensor placed directly into the heart was the only way to see how the heart worked.     Currently, there are monitors that can sense the heart's activity via sensors that are placed     on the skin during cesarean delivery.      In this study, the investigators will use the ICON cardiac output (ICON) monitor. The ICON     monitor is approved by the US Food and Drug Administration (FDA) to monitor (check) the     activity of your heart.      This study aims to:        1. Determine if additional cardiac output measurements help anesthesiologists maintain          appropriate hemodynamics as defined as within 20% of baseline BP and if it changed their          choice of vasopressors (primary outcome).        2. Determine if additional cardiac output measurements help to decrease the incidence of          nausea and vomiting during cesarean delivery (secondary outcome).   "
103698|NCT01928784|"     The aim of this prospective study is to explore the pain-alleviating effect of low-energy     extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.   "
103699|NCT01928771|"     The purpose of this study is to determine whether Benralizumab reduces the number of asthma     exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.   "
103700|NCT01928758|"     The overall aim of this project is to evaluate the effect of progressive nicotine reduction     in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with     comorbid mood and/or anxiety disorders.      Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain     either a) nicotine content similar to their preferred usual brand of cigarettes, or b)     nicotine content per cigarette that is progressively reduced from approximately 11 mg to 0.3     mg over 6 months.      It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine     content in the Reduced Nicotine Content group without significant increases in tobacco smoke     exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or     protocol non-adherence over time in the Reduced Nicotine Content group as compared with the     control group.   "
103701|NCT01928745|"     To diagnose acid base disturbances using blood gas analysis, multiple approaches are     currently in use. These include the classic Henderson-Hasselbach bicarbonate approach and the     physiochemical approach by Stewart1. All have shown to be mathematically compatible2.      Diagnosing the metabolic component of acid base disturbances relies on the assessment of the     so called ion gaps: the anion gap for the classic acid-base approach and the strong ion     difference (SID) for the Stewart approach. This gap may unveil unidentified anions to provide     a more accurate diagnosis. In particular they allow differentiating between relative     hyperchloremia and other strong ions such as lactate, ketones, salicylates, citrate and     ethylene glycol3.      The accuracy of both gaps relies on the estimation of the weak acid dissociation: A-. This A-     is dependent on the total concentration of weak acids (Atot) of which albumin is the most     important and the effective dissociation constant for these (Ka), which determines the     dissociated fraction of the Atot. This dissociation fraction needs to be accounted for in the     ion gaps. This is reflected in the recommendation to correct the anion gap for albumin and     incorporated in the SID which includes a factor for albumin by design3,4. However, the     correction factor for albumin is currently based on data from animals and healthy     volunteers4-9. In the critically ill albumin and protein content are very different compared     to healthy volunteers, most notably in sepsis. Further, it is unknown if subunit composition     of albumin is different in these patients. In addition, different protein species may be     either up or downregulated in the critically ill1,8,9.Therefore from a pathophysiological     point of view Atot and Ka and thus A- may differ in the critically ill. However it has not     been previously investigated if and to what extent these matters affect Atot and Ka and     therefore A- in this population.      In addition, previous studies looking into this values showed a higher than expected value of     unmeasured anions from the gap calculations. Despite rigorous experimental effort including     high performance liquid chromatography, the origin of these unmeasured anions have not yet     been elucidated17-20. However if the assumptions made in the Stewarts approach would not be     valid, the existence of these unknown anions may have to be questioned.      Thus it is of great interest to experimentally determine the exact contribution of the weak     acids and their dissociation in sepsis. This could have major implications for these patients     because different assumptions will ultimately lead to alterations in their calculated anion     gap or SID. This may reduce unnecessary diagnostic test, alter final diagnosis and hence     alter therapy.      In this study the investigators aim to experimentally determine the Atot and Ka and thus     their dissociated fraction A- in critically ill septic patients admitted to the intensive     care unit by using in vitro CO2 tonometry, plasma dialysis and Marquardt regression analysis.     In addition, as a control the investigators will do the same for patients admitted to the     intensive care after routine cardiac surgery. Furthermore Atot and Ka values for both groups     will be compared to values obtained from human volunteers in a previous study4.      To achieve this, the investigators will plot CO2 versus pH titration curves from plasma     samples of these patients. The investigators will then use Marquardt nonlinear regression     analysis to quantify Atot and Ka and the SID by simultaneously solving for these     parameters21. To make the quantification for Atot and Ka more robust, the investigators will     also perform the same experiments after dialyzing the obtained plasma samples against a     crystalloid solution of known composition in order to eliminate errors related to estimation     of the SID. Finally, Atot and Ka values for both groups will be compared to values obtained     from human volunteers in a previous study4. For application in the bicarbonate and base     excess centred frameworks, Atot and Ka values will be related to albumin and protein content     to update the correction factor for the anion gap in critically ill.   "
104877|NCT01913366|"     Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the     University of California, San Francisco is conducting a study comparing two types of     interventions for treating depression in rural older adults.   "
103713|NCT01928589|"     Women with ER negative breast cancer have a higher risk of the cancer returning in the breast     after whole or partial breast radiation than women with ER positive breast cancer. In a small     study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy     given at the same time. This combined treatment was safe and women with ER negative breast     cancer did just as well as women with ER positive cancer.      We are now testing in a bigger study whether giving partial breast irradiation and     chemotherapy at the same time (our new method) has the same side effects and outcomes as     giving partial breast irradiation and chemotherapy at different times(older method). In this     study women who had their breast cancer removed but need radiation to the breast will be     randomized to partial breast irradiation at the same time as chemotherapy or partial breast     radiation at a different time than chemotherapy. Randomization is like flipping a coin but in     this study about 2 of every 3 women will get the new method.   "
103714|NCT01928576|"     Response Rate   "
103702|NCT01928732|"     VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of     psychotherapy, Prolonged Exposure and Cognitive Processing Therapy, for treating     posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence that     both treatments are effective in Veterans and non-Veterans, there is a lack of evidence about     the effectiveness of these treatments compared with one another.      The sample will include 900 male and female Veterans with PTSD due to any traumatic military     event. Veterans who are eligible and agree to participate in the study will be randomly     assigned (by chance) to receive Prolonged Exposure or Cognitive Processing Therapy. The     standard dose of treatment is 12 weekly sessions but Veterans who improve more rapidly may     finish in fewer sessions and Veterans who improve more slowly may have additional sessions.     The primary outcome is improvement in PTSD symptoms after treatment. The outcome will be     measured at regular follow-up visits that will occur at the middle and at the end of     treatment and then 3 and 6 months later. The investigators will measure other outcomes,     including additional mental health problems, functioning, quality of life, and use of     treatments for mental and physical problems. The investigators also will measure Veterans'     treatment preference and examine whether Veterans who get the treatment they prefer do better     than Veterans who get the less-preferred treatment.      As a large multi-site trial with men and women, CSP #591 is designed to provide conclusive     information about whether one treatment is better than the other, overall and for different     types of patients-for example, men vs. women, combat Veterans vs. Veterans who experienced     military sexual trauma, and older vs. younger Veterans. Regardless of the outcome, patients     will have more information to help them make an informed decisions about which treatment to     choose and VA will have stronger evidence to help make care Veteran-centered.   "
103703|NCT01928719|"     The overall goal of this study is to address the question of whether progressively lowering     nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low     socioeconomic status   "
103704|NCT01928706|"     Purpose: the aim of the present study was to analyze the impact of mandibular denture     relining with soft or hard denture liners in the oral health related quality of life (OHRQoL)     of edentulous patients.      The null hypothesis was that there would be no difference in OHRQoL findings after mandibular     denture relining between patient groups treated with hard or soft denture liners.   "
103705|NCT01928693|"     This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic     agents to determine the optimal treatment in patients with infectious corneal ulcers.   "
103706|NCT01928680|"     It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in     anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.   "
103707|NCT01928667|"     The purpose of the study is to assess among others environmental and hygiene-related risk     factors for microscopic colitis (MC), a common diarrheal disease.   "
103708|NCT01928654|"     Macular edema is the most important cause of visual impairment in diabetic patients.     Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser     treatment are two effective therapies for stabilising visual acuity. However, antiVEGF     therapy is very expensive and potentially needs to to be repeated for all patients life.     Laser treatment, according to modified ETDRS (early treatment diabetic retinopathy study),     produces retinal burns with possible negative consequences such as alterations in the visual     fields.      With micropulse treatment modality laser energy is delivered in short pulses (micropulses)     rather than as a continuous wave. In this way the amount of energy delivered to the retina     and retinal pigment epithelium (RPE) is significantly reduced. This finer control of the     photothermal effects should avoid any retinal and RPE damage. At the same time, according to     several published reports, the efficacy of treatment appears to be equivalent to conventional     laser therapy.      Previous studies investigated the effects of 810nm micropulse laser therapy. Recently, this     treatment modality has been made available also with 577nm wavelength, which corresponds to     the maximum absorption level for blood. Aim of this study is to assess the safety and     efficacy of 577nm micropulse laser treatment compared to conventional modified ETDRS laser     therapy.   "
103709|NCT01928641|"     Intravenous tissue plasminogen activator (IV t-PA) is the only proven treatment of hyperacute     cerebral infarction. The outcome of this treatment highly depends on the time from symptom     onset to the administration of thrombolytic agent. Last known normal time is widely used as     the standard to determine the symptom onset. These stroke symptoms are usually caused by a     sudden decrease in cerebral blood flow related with an embolic or thrombotic event. However,     in some cases various symptoms may occur one after another.      Myocardial infarction is also caused by a sudden caseation of blood flow. The symptom of     myocardial infarction usually contains chest pain, and it is easy to identify the exact time     of onset. In contrast, cerebral infarction may cause various symptoms according to the     infarcted area of the brain, and sometimes multiple symptoms are presented in rapid     succession. Therefore, it may be much unclear and uncertain to determine the onset time of     cerebral infarction. Despite the importance of onset time in therapeutic decision making,     there was no study focusing on the certainty of onset time in cerebral infarction patients.      In this study, we will investigate the subjective certainty of patient about the onset time     in clear-onset cerebral ischemia. The discrepancy in diagnosing the onset time will be     analyzed among the clinicians involved in the practice. Then, the factors associated with     this uncertainty will be verified.   "
103710|NCT01928628|"     This study aims to compare and assess the efficacy and the safety of the combination agent of     Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential     hypertension   "
103711|NCT01928615|"     This open-label, randomized crossover study evaluated the quality of life, efficacy, and     safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper     arm of participants with early HER2-positive breast cancer.   "
103712|NCT01928602|"     The few studies looking systematically into the neurophysiological and neuropsychological     components of available therapies for chronic aphasia are highly heterogeneous in nature.     Results from these studies have, unsurprisingly, indicated heterogeneous results, such as     dissimilar neural outcomes associated with neuropsychological gains. There is, therefore, no     consensus of how a successful therapy— that is, one that produces a measurable language gain     in either production or comprehension —impacts the functional language networks of the brain     in a specific type of aphasia population.      A recent study has shown that inner speech (the imagination of speech) involves networks and     areas dissociable from those implicated in speech production. Further, behavioural analysis     has shown an interesting discrepancy between inner speech and overt speech (also called     speech production) in a small chronic aphasia population: some participants elicited poor     inner speech coupled with relatively intact overt speech, while others elicited relatively     intact inner speech coupled with poor overt speech. This unexplored discrepancy implies that     inner speech and speech production are dissociable, though share similar networks.      This discrepancy, and the notion that these speech components share a similar network, drives     this study's hypothesis that improvement in speech production after rehabilitation might be     facilitated by an intact inner speech network. Much as good athletes visualise their     performance before the actual event in order to increase their chances of success, so too     might intact inner speech facilitate speech production, helping to visualise the word in     order to increase the success of produced speech.      By studying a specific component of speech—inner speech—in a relatively homogeneous     population of chronic expressive aphasics, the present study provides an explicit, critical     means of understanding neurophysiological (as assessed by functional magnetic resonance     imaging) and neuropsychological (as assessed by language batteries and personal     questionnaires/interviews) changes occurring during speech therapy.      As a secondary objective, this study will explore the effectiveness, feasibility and     adherence to an at-home computerised aphasia software delivered via a portable tablet.   "
103716|NCT01928550|"     The purpose of this study is to evaluate the effectiveness of investigational Doppler Optical     Coherence Tomography (OCT) and OCT angiography in the management of proliferative diabetic     retinopathy (PDR - a leading cause of blindness in diabetic patients) before and after     treatment. Angiography is the mapping of the blood vessels, and Doppler detects blood flow.     PDR is due to poor oxygen circulation in smaller blood vessels in the back of the eye     (retina), and is observed in 80% of people who have had diabetes for more than 10 years. This     study will look at how blood flow to the eye is affected before and after treatment.   "
103717|NCT01928537|"     This study will examine the effect intravenously administered rigosertib has on the     relationship between bone marrow blasts response and overall survival in myelodysplastic     syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after     treatment with azacitidine or decitabine.   "
103718|NCT01928524|"     The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of     docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.   "
103719|NCT01928511|"     Patients with Chronic Hepatitis B on long term oral antiviral therapy have to continue     treatment indefinitely unless they achieve HBeAg seroconversion or HBsAg seroclearance, when     therapy can be stopped. While HBeAg seroconversion is a more achievable endpoint, only 20-25%     of patients develop this after one year of oral antiviral therapy. HBsAg seroclearance is     universally infrequent. Strategies to improve these endpoints such as combination oral     antiviral therapy have not been generally successful and recently studies have examined the     possibility of switching or adding peginterferon therapy. However these have not been tested     adequately in the group of patients that have been on long term oral antiviral therapy.     Consequently this study was conceived to evaluate whether switching or adding peginterferon     compared to continuing oral antiviral therapy are more efficacious strategies. HBeAg positive     and HBeAg negative patients (n=310)will be randomised to continue oral antiviral therapy,     switch or add pegylated interferon for 48 weeks in a ratio of 1:2:2 respectively. The study     endpoints are HBsAg seroclearance, reduction of qHBsAg >1 log, qHBsAg<200 IU/ml, HBeAg loss     and seroconversion, and HBV DNA suppression, all at week 72.   "
103720|NCT01928498|"     The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon     catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of     hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.   "
103721|NCT01928485|"     This randomized phase II trial studies how well green tea extract works in treating patients     with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or     slow the growth of certain cancers.   "
103722|NCT01928472|"     Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults     between the ages of 18 years and 65 years.   "
103723|NCT01928459|"     To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose     tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.   "
103724|NCT01928446|"     Observational evidence and findings from clinical trials conducted for other reasons suggest     that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent,     depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has     not yet been adequately examined in a randomized clinical trial conducted specifically to     test lithium's efficacy in preventing suicides. This clinical trial fills this gap.      This study is feasible within the Department of Veterans Affairs (VA) because it is a large,     integrated health system with existing programs for identifying patients at risk for suicide     and delivering enhanced services. In VA, approximately 12,000 patients with depression or     bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them     repeat within one year. Experimental treatment in this study will supplement usual care for     major depression or bipolar disorder, as well as VA's standard, enhanced management for     patients at high risk.      The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals.     Participants will be patients with bipolar disorder or depression who have survived a recent     episode of suicidal self-directed violence or were hospitalized specifically to prevent     suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the     patients nor their doctors will know whether a particular person has received lithium or     placebo. The treatment will be administered and the patients will be followed for one year,     after which patients will go back to usual care. Recruitment will occur over 3 years.      The investigators are primarily interested in whether lithium leads to increases in the time     to the first repeated episode of suicidal behavior, including suicide attempts, interrupted     attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In     addition, this study will allow us to explore whether lithium decreases the total number of     suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive     behaviors. If there is an effect of lithium, the investigators will be interested in whether     or not it could be attributed to improved control of the underlying mental health condition,     or, alternatively, whether it represents a direct effect of suicide-related behavior.   "
103725|NCT01928433|"     The primary objective of this study is to evaluate the microbiological and clinical outcome     of treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus     ciprofloxacin for 10 days as a reference comparator.      Finafloxacin shows increased activity in an acidic environment which is associated with     indications such as uUTI and cUTI. Given the acidic pH of urine and concentration of     finafloxacin excreted via the urinary tract in humans it should be proven if the finafloxacin     treatments offer significant advantages over the currently available treatments for UTI.   "
103726|NCT01928420|"     The purpose of this study is to evaluate the safety and efficacy of NIC5-15 in the treatment     of Alzheimer's Disease.   "
104878|NCT01913353|"     To demonstrate the efficacy of MVA-BN® by showing that vaccination prior to administration of     ACAM2000® results in an attenuated take.   "
103727|NCT01928407|"     A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the     antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in     combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in     HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.   "
103729|NCT01928381|"     This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting     training program in which a painful stimulus will be applied to the subject's hand, and the     subjects will be asked to report how painful the stimulus is. Over the course of the pain     training sessions, feedback will be provided to the subject about how accurately they are     reporting their degree of pain, relative to the amount of pressure stimulus applied to evoke     pain. Those subjects who have adequate pain reporting ability will be asked to continue into     Part 2 of the study in which 3 different blinded study drugs will be administered to each     subject, in a crossover design to compare whether or not the study drugs improve pain     associated with diabetic neuropathy.   "
103730|NCT01928368|"     The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy     subjects and subjects with mild atopic asthma.   "
104722|NCT01915407|"     To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet     dysfunction.   "
103731|NCT01928355|"     There is some evidence to suggest that obesity is a risk factor for the development of     cognitive dysfunction, although this is not a universal finding. This discordance might be     ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of     metabolic risk factors. We examined whether the association of obesity with cognitive     dysfunction is dependent on the individual's metabolic health.      60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was     defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol,     triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as     'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic     abnormalities). Cognitive dysfunction will be assessed by moca and minimental score. Results:     Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was categorized     as metabolically healthy. Relative to non-obese healthy participants, after adjustment for     baseline covariates, the metabolically unhealthy obese participants had elevated risk of     cognitive dysfunction although the metabolically healthy obese did not. The association     between obesity and risk of cognitive dysfunction appears to be partly dependent on metabolic     health, although further work is required to confirm these findings.      In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese     patients suffer from higher incidences of cardiovascular complications such as     atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein     which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are     three different types of Hp which differ in their antioxidant ability. Several clinical     studies have shown that Hp 2-2 genotype is associated with higher incidence of cardiovascular     diseases.   "
103732|NCT01928342|"     The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a     natural hypolipidemic compound, coenzyme A （CoA） capsule, combined use with statin, in     Chinese patients with moderate dyslipidemia.   "
103733|NCT01928329|"     The goal of the proposed pilot study is to determine whether glucose control can be improved     with Bydureon treatment in patients with type I diabetes (T1D)   "
103734|NCT01928316|"     The purpose of the study is to evaluate the bioequivalence (the way in which different forms     of the same drug are absorbed in the body) of single-dose administration of domestic (made in     China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy     volunteers   "
103735|NCT01928303|"     This study will develop and test an algorithm that will estimate drug dosage from drug levels     measured in oral fluid (saliva). Traditionally, urine has been used as the principle medium     to monitor drug compliance in patients receiving opioids for chronic pain as well as those     being treated for substance abuse. Recently, the use of saliva as an alternative to urine     drug testing has been gaining in popularity. Oral fluid has several advantages over urine as     a medium for drug screening. In this study, oral fluid, urine and blood specimens will be     collected from volunteer patient donors with chronic pain taking opioid medications. Samples     from the anonymous donor will be analyzed for opiate class drugs, using New York State     Department of Health approved and validated laboratory methods. Analytical results and other     information collected will assist in evaluating the use of oral fluid as a specimen to detect     opiate drug levels. The measurement of drug concentrations in blood and oral fluid     simultaneously will allow for the determination of the amount of oral fluid that will be     needed for successful drug testing. It is proposed that by measuring oral fluid drug levels     an estimate of the amount of drug taken will be possible.   "
103737|NCT01928277|"     The main objective of the study is to examine the extent of agreement between patient and     health care provider assessments of work of breathing and the association of agreement with     demographic- and disease-related factors.   "
103738|NCT01928264|"     We will conduct a randomized control trial to investigate whether and to what extent regular     and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves physical     fitness and (physio-)psychological functions (like subjective sleep, mental toughness,     perceived stress, self-efficacy, etc.), as well as participation skills and the ability to     work, in claimants for a disability pension due to psychiatric disorders, whose ability to     work had recently been assessed by means of a psychiatric expert opinion. The control group     is designed very similar and implies predominantly sedentary leisure time group activities     (e.g. playing board games, doing handicrafts). Measures will be performed at baseline,     post-test, and at follow ups three and twelve months after post-test, some variables will     additionally be assessed 4-weekly during the intervention. We expect that intervention group     participants will report and show, respectively, more improved physical fitness,     (physio-)psychological functioning and participations skills, as well as increased ability to     work, compared to the control group.   "
104974|NCT01912092|"     The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing     local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with     Askina® Calgitrol® Paste.   "
103739|NCT01928251|"     According to the Census & Statistics Department (2011), there are still 659,300 daily smokers     (11.1%) in Hong Kong. Smoking and passive smoking kill over 7,000 people per year. Smoking is     addictive, and it is difficult for some motivated smokers to quit without assistance. On the     other hand, many smokers may not be ready to quit or want to quit on their own, so it is     difficult to reach them.      Quit and Win programme is an opportunity to reach and encourage a large group of smokers to     make quit attempt. Quit and Win Contest assumes that smokers can develop a higher motivation     to quit and gain a wider social support in quitting. According to Cahill and Petera (2011),     smokers can develop a high motivation to quit and gain a wider social support through     participating in the Quit and Win Contest.      The Hong Kong Council on Smoking and Health (COSH) organized three Quit to Win Contests and     recruited over 3000 smokers from 2009-2012. These events enhanced the motivation and     confidence to quit smoking. Lucky draw was also conducted to attract smokers to quit smoking     and winners were validated by biochemical tests.      Community-Based Participatory Research (CBPR) is an partnership approach that can enlighten     and utilize the network within communities as community partners can obtain ample manpower     and social resources. To effectively raise the awareness of the contest and recruit as many     participants as we can from the community, working with NGOs in the 18 Hong Kong districts     with a CBPR model may be one effective way of program implementation.      Thus, we proposed to (1) test the effectiveness of combining competition and short-term     monetary incentives to motivate smokers who participate in the Quit to Win Contest 2013 to     quit smoking; (2) use a Community-Based Participatory Research (CBPR) model to build capacity     and to engage community partners in taking on this important public health issue for     sustainability in the community; and (3) conduct the process evaluation to assess the     effectiveness of the recruitment activity and how it is linked with the overall program     outcomes.      Hypothesis:      To examine the effectiveness of the interventions, three arms are (i) Group A: Informed early     monetary incentive, which participants will be notified of the incentive through telephone     follow-up at 1-week and 1-month follow-ups; (ii) Group B: Uninformed early monetary     incentive, which participants will not be informed about the incentive until 3-month     telephone follow-up; (iii) Group C (control group): Uninformed late monetary incentive, which     participants will not be informed about the incentive throughout 1-week, 1-month and 3-month     follow-ups.      The primary outcomes are the self-reported 7-day point prevalence (pp) quit rate at 3 months     of group A compared to group B and group C. The secondary outcomes include (i) self-reported     7-day point prevalence (pp) quit rate at 6 months, (ii) biochemical validated quit rates,     (iii) rate of smoking reduction by at least half of baseline amount, (iv) number of quit     attempts at 3 and 6 months among the three groups and (v) the above cessation outcomes of all     subjects, including or not including in the RCT.   "
103740|NCT01928238|"     The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient     ventilator synchrony during non-invasive neurally adjusted ventilatory assist or     pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in     patient at risk of respiratory distress after extubation.   "
115022|NCT01780311|"     A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs     for outflow tract ventricular arrhythmias   "
103741|NCT01928225|"     Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor     response to treatment of cervical cancer precursors. This study will test whether giving the     quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor     will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced     occurrence or cervical cancer precursors in follow-up.   "
103742|NCT01928212|"     Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can     provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer     (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in     several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's     disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a     common neurodegenerative disease characterized by motor dysfunctions, originally described by     James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss,     which may correlate with RNFL thinning. Previous studies on this subject, however, reported     contradicting results. Some investigations reported reductions of the RNFL thickness while     others did not. In the present study, in order to determine whether RNFL thickness is reduced     in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness     measurements with OCT in a series of PD patients and in the healthy control groups.   "
103743|NCT01928199|"     The purpose of this study is to determine whether sitagliptin is effective in preventing the     development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of     previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and     calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute     to diabetes development through multiple mechanisms; including decreased insulin production     by the pancreas. Sitagliptin is an oral medication that results in increased insulin     secretion. We hypothesize that administration of sitagliptin to transplant recipients     identified to be at risk for diabetes development will reduce the incidence and severity of     NODAT.   "
103744|NCT01928186|"     This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography     (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor     (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast     cancer. Comparing results of diagnostic procedures done before and during hormone therapy may     help doctors predict a patient's response to treatment and help plan the best treatment.   "
103745|NCT01928173|"     The purpose of this study is to test the effectiveness of a 1-session abbreviated     cognitive-behavior therapy for insomnia among college students. The investigators will     examine the following hypotheses in the present study: 1) Viewing the treatment video will     produce an increment in sleep knowledge relative to baseline and minimum treatment control;     and 2) Viewing the treatment video will result in improved sleep relative to baseline and     minimum treatment control.      Students who self-identify as having insomnia will be recruited from the University of     Alabama's Psychology subject pool. Students who enroll in the study will receive a link to     the demographic and screening questionnaire. Individuals who have a history of other sleep     disorders or who currently present with symptoms strongly suggestive of sleep disorders, such     as obstructive sleep apnea or narcolepsy will be excluded. Individuals who are shift-workers     and those with a history of severe mental illness will also be excluded.      Participants who meet criteria for this study will then be directed to complete a measure of     sleep knowledge. Once they have completed the measure of sleep knowledge, they will be     directed to complete the Consensus Sleep Diary (CSD) for 14 days as soon as possible after     awakening in the morning. During the second week of completing the CSD, participants will be     directed to complete the Insomnia Severity Index and the Patient-Reported Outcomes     Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms on     the last day they complete a CSD.      Participants will be randomized to a treatment group or a minimum treatment control group     upon completion of these baseline measures. Those in the treatment group will be emailed the     following components of the insomnia treatment: a link to the treatment video, an mp3 file     with a relaxation recording, and a pdf file of a brochure reviewing the information presented     in the treatment video. Participants will be asked to view the treatment video and begin     practicing the relaxation technique presented in the mp3 file as soon as possible.     Participants in the minimum treatment control group will receive a link to a sleep education     video.      Two weeks after participants have viewed the videos, they will be asked to complete     post-treatment measures in the same sequence as they did at baseline. One month after the     post-treatment measures have been completed, both groups will be asked to complete the same     measures again for follow-up.   "
103759|NCT01927991|"     Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to     provide psychotherapy. For several psychological and psychosomatic disorders, treatment     efficacy was shown. Previously, iCBT has also been applied to patients suffering from     tinnitus and results show significant and long-term stable improvements in tinnitus distress.     However, the role of therapeutic support in iCBT has not been thoroughly investigated.     Previous results suggest that iCBT without therapeutic support is less effective and leads to     higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial     is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.   "
125360|NCT01644292|"     The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills     home training program for older adults in preparation for a third phase feasibility study.   "
103746|NCT01928160|"     This randomized phase II trial studies how well pemetrexed disodium and carboplatin or     cisplatin with or without erlotinib hydrochloride work in treating patients with epidermal     growth factor receptor (EGFR) mutant positive stage IV non-small cell lung cancer and     acquired resistance to first-line therapy with erlotinib hydrochloride or gefitinib. In     patients that develop resistance to first-line therapy with EGFR tyrosine kinase inhibitors     (TKIs) the drug is usually stopped and the patient is switched to chemotherapy. Drugs used in     chemotherapy, such as pemetrexed disodium, carboplatin, and cisplatin, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. It is not yet known whether pemetrexed disodium and     carboplatin or cisplatin is more effective with or without erlotinib hydrochloride in     treating patients with EGFR mutant non-small cell lung cancer and acquired resistance to EGFR     TKIs.   "
103747|NCT01928147|"     PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is     being developed as a potential treatment for hepatitis C virus infection. This study is being     done to assess the dose-related safety and tolerance of PPI-383 when given to healthy     volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3     days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the     bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C     virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.   "
103748|NCT01928134|"     This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to     produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There     are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of     bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis     improvement; (4) safety evaluation.   "
103751|NCT01928095|"     The research objectives of this project are as follows:        1. Obtain high-quality human atherosclerotic arterial samples from diseased donors.        2. Perform biochemical analysis to determine the abundance, localization and activity of          Dicer and double-stranded RNAs in these diseased tissues.   "
103752|NCT01928082|"     The purpose of this study is to assess if estrogen replacement normalizes urinary calcium     excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for     differences in response to estrogen replacement in women with familial hypercalciuria     compared to nonfamilial hypercalciuria.   "
103753|NCT01928069|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.     Dosing periods were separated by a washout period during fed study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
103754|NCT01928056|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.     Dosing periods were separated by a washout period during fasted study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
103755|NCT01928043|"     This study will enroll 30 adolescents with bipolar disorder (BD) who are suffering from     symptoms of depression despite already taking a traditional mood-stabilizing medication.     Curcumin will be added to their current medications for 8 weeks. During these 8 weeks, their     mood symptoms will be assessed regularly. Height, weight, and blood pressure will also be     measured repeatedly. Blood tests will be completed before treatment, after 4 weeks of     treatment, and at the end of the study. Blood tests will allow us to determine whether     changes in inflammation and oxidative stress explain curcumin's effect on mood. Finally, we     will use sophisticated technology to measure blood vessel functioning. We have three main     predictions: 1. Curcumin will improve mood symptoms without causing physical problems; 2.     Curcumin will reduce inflammation and oxidative stress, and these reductions will be linked     to improvements in mood; 3. Curcumin will improve blood vessel functioning, and these     improvements will be linked to improved inflammation and oxidative stress.   "
103756|NCT01928030|"     This phase 1-2 trial studies the side effects and the best dose of recombinant human     hyaluronidase and to see how well it works in treating lymphedema in patients with cancer.     Recombinant human hyaluronidase (r-hu-hyaluronidase, rHuPH20) may reduce limb edema size in     patients with lymphedema.   "
103757|NCT01928017|"     This is a prospective observational clinical study to characterise abnormalities of     thromboelastography (TEG) parameters in patients with chemotherapy-induced thrombocytopenia.     The investigators are also studying the relationship between Multiplate analysis and bleeding     in these patients and the effect of platelet transfusions on thrombopoietin level and percent     reticulated platelets.      The investigators' hypothesis is that changes in TEG-parameters reflect the patients tendency     to bleed.   "
103758|NCT01928004|"     The purpose of this study is to investigate denture satisfaction following the conversion of     existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous     patients who depend on help for activities of daily living (ADL) and evaluate secondary     endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome     measures.   "
103760|NCT01927978|"     This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging,     therapy planning, and therapeutic response monitoring for esophageal cancer patients.      Purpose:        1. The incremental staging information by using 18F-FDG PET        2. The impact of the PET results on the patients' subsequent therapy planning        3. To compare treatment response using RECIST criteria and FDG PET results.   "
103763|NCT01927939|"     This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic     bone lesions and in predicting outcome for breast cancer patients after therapy.      Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment.     The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.      Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic     bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.   "
103764|NCT01927926|"     Developing functional foods that enhance satiety may be beneficial to individuals to help     manage body weight.      We have previously shown that consuming a mid-morning liquid preload with increasing     proportion of energy derived from whey protein and addition of polydextrose reduced voluntary     energy intake at a lunchtime meal compared to a liquid preload of the same energy content but     lower in protein and containing no polydextrose.      This study aims to investigate if these results can be replicated when the preload is in the     form of a snack bar. We will also investigate whether the daily consumption of the snack bar     has an effect on energy intake, subjective appetite and metabolic parameters compared to a     control snack of the same energy but with a minimal protein content and without the addition     of polydextrose.      We hypothesize that the whey protein polydextrose snack will reduce voluntary energy intake     at a subsequent test meal, suppress subjective appetite ratings compared with the control     snack bar.   "
103765|NCT01927913|"     The purpose of this open-label study is to assess liver iron concentration using MRI imaging     in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the     treatment of chronic transfusional iron overload.   "
103766|NCT01927900|"     The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study     with healthy volunteers. A total of 100 male and female volunteers will be included. The     volunteers will be randomized into one of 10 groups, each of 10 participants, consuming     either active product in various mixes and doses (9 groups) or placebo product (1 group) for     2 weeks. The 9 groups receiving active product will receive either one of two Human Milk     Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of     the study is establishing the effects of various compositions and doses of HMOs on the faecal     flora and on gastrointestinal symptoms in health adults.   "
103856|NCT01926717|"     This study is being done to learn more about how different surgery procedures bring back the     quality of life.After removing the small intestine at least 20cm in patients with pancreatic     cancer, Some patients develop problems because they are disorder their digestive system, such     as cramping, heartburn,vomiting.   "
103767|NCT01927887|"     The purpose of this research study is to see if a specific kind of MRI can identify small and     otherwise undetected abnormal lymph nodes in patients with thyroid cancer who are undergoing     surgery. The MRI is called Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance     Imaging (USPIO MRI), and uses an experimental contrast agent (ferumoxytol), to try to     identify these lymph nodes. The MRI uses magnetic waves to take images (pictures) of the body     and is commonly used in medical testing.      Ferumoxytol is FDA approved as an iron replacement product for the treatment of iron     deficiency anemia in adult patients with chronic kidney disease.      In this research study, the investigators want to see if Ferumoxytol will help to identify     very small metastases that are not usually seen on standard MRI scans. If the use of USPIO     MRI with the experimental agent ferumoxytol identifies very small metastases in lymph nodes,     your surgeon may decide to remove them. After the surgery, the nodes will be stored and then     analyzed to assess the ability of USPIO MRI and ferumoxytol to detect cancer in very small     metastases in the lymph nodes.   "
103768|NCT01927874|"     There will be compared the postoperative analgesic effect of infiltration or spinal block for     hemorrhoidectomy   "
103769|NCT01927861|"     This trial is conducted in Asia. The aim of the trial is to investigate the long-term     efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan     syndrome.   "
103770|NCT01927848|"     Knee related mobility limitations are the leading cause of disability in the western world.     It is a very expensive and debilitating condition when the cost of lost productivity and     personal assistance is considered.      In recent years there has been a growing interest in alternative medicine and many     individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been     particular popular, and has been shown effective in relieiving pain - albeit the evidence is     scarce.      The purpose of this study is to evaluate the efficacy of specialized rosehip powder     nutritional additives (Rosenoids®) on knee joint function during walking in subjects with     knee-related walking limitations.   "
103771|NCT01927835|"     The purpose of this study is to evaluate the safety and immune response to two different HIV     vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.   "
103772|NCT01927822|"     This study aims to analyze the factors influencing the abortion interval of second-trimester     termination of pregnancy using misoprostol.   "
103773|NCT01927809|"     Hirschsprung's disease is a complex genetic disorder. The etiology of this disease is not     completely understood. It is characterized by the absence of ganglia (nerve cells) in de     distal colon. This impairs bowel relaxation which can lead to bowel disfunction, toxic     megacolon, ileus and enterocolitis. So far, several genes have been identified that play a     role in Hirschsprung's disease. The precise mechanisms however, remain unclear. This study     wants to identify new mutations and hopefully clarify more about the etiology of the disease.   "
103783|NCT01927666|"     The variation in extent of isothiocyanate (ITC) excretion in urine from a capsule delivered     dose of glucoraphanin will correlate with differences in (a) the gut microbiota, and (b) the     genotype of key polymorphic genes (GSTM1, GSTT1, and other as yet undetermined candidate     genes).      Our study is a human dietary intervention in which participants will consume one capsule     containing 100mg purified glucoraphanin from broccoli. The levels of glucoraphanin delivered     by the capsule are similar to one to two portions of broccoli. As this is purified     glucoraphanin there is no myrosinase enzyme present. All conversion of the glucoraphanin,     contained within the capsule, to ITC will therefore occur by enzymes found in the gut     microbiota.      The ability of the glucoraphanin in the capsule to be metabolised to ITCs by the gut     microflora is unknown and will be assessed by measuring ITCs excreted in the urine. The ITCs     will be quantified in urine using validated analytical methods.      It has been shown in human dietary intervention studies that the extent of conversion of     glucosinolates varies greatly. In order to assess possible causative factors for variation in     rate of glucoraphanin metabolism each participant will provide a faecal sample from which     their faecal gut microbiota phylogeny will be analysed.      For a small number of participants a second faecal sample will be requested (a maximum of 3     participants). It is our aim to select one low, one medium and one high ITC excreter. Ideally     the low and high excreters would be within the lowest and highest 5% excretion of ITC and the     third participant would be as close to the mean ITC excretion as possible. The aim would be     to culture the faecal microbiota over time with repeat dosing of glucoraphanin in order to     select for microbiota that are able to metabolise glucoraphanin. It is known that the main     hydrolysis product of glucoraphanin, sulforaphane, has a variety of benefits to human health,     however there is no known clinical relevance to being a high, medium or low excreter of ITC.      For each participant a blood sample will also be requested in order that we can assess     whether genotype affects the rate of ITC excretion in urine. The GSTM1 genotype and other, as     yet, unidentified candidate genes of each participant will be determined. Whether the     genotype affects the rate of ITC excretion either alone or in combination with the     phylogenetic profile will be assessed.   "
103774|NCT01927783|"     Background:      - Past studies suggest that the best way to improve heart health in the Black community is     through community-based programs. Researchers will partner with DC community leaders. They     will collect information about the health and health needs of people in mostly Black churches     in DC. They will study things that affect heart health, like diabetes, blood pressure,     cholesterol, and weight. They will also study how technology can keep track of activities and     health. The information will show the health needs of this church-based community.      Objectives:      - To create an intervention for future programs to improve heart health in African-American     churches in Washington, DC.      Eligibility:      - Adults ages 19 to 85 who attend one of the study churches.      Design:        -  Participants will visit their church for a 4-hour health exam. They will have their          blood pressure and body measurements taken. They will have a drop of blood taken from          their finger with a small needle. This blood will be tested for blood sugar and          cholesterol. Participants will be given the results of these tests.        -  Participants will answer questions about their health.        -  All participants will be given an activity monitor to wear for 1 month. The activity          monitor is worn around the wrist. Some participants will also receive an activity          monitor that is worn around the waist. Participants will be given instructions on how to          wear the activity monitors and follow the results on a website.        -  At the end of 1 month, participants will return one device (they can keep the other).          They may receive a gift card for completing the study.   "
103786|NCT01927627|"     The purpose of this study is to see how long it takes for prostate cancer to come back in     patients who have had surgery to remove their prostate gland (radical prostatectomy), while     being treated with enzalutamide (formerly known as MDV3100).      Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks     activity of the male hormone, testosterone. Most prostate cancers are dependent on     testosterone for growth. In this study, patients will take enzalutamide after surgery to see     if it keeps their cancer from coming back.   "
103934|NCT01925703|"     Intravenous iron replacement has been shown to benefit patients with heart failure and iron     deficiency, but the weekly outpatient regimens studied to date are impractical for many     patients. Our purpose is to evaluate the short-term effects and safety of an accelerated     intravenous iron regimen in hospitalized patients with these two conditions.   "
103775|NCT01927770|"     Background:      The purpose of this study is to investigate the process of consenting participants to whole     exome/genome sequencing and its outcomes. It is unknown how best to consent people to this     new technology. NO GENOME SEQUENCING IS OFFERED AS PART OF THIS STUDY. This protocol is a     companion to other NIH studies that involve genomic sequencing. Participants must be enrolled     in a parent NIH study that is collaborating on this consent study to be eligible. Currently     this involves only one NIH study.      Objectives:      - To learn the best way to help participants understand sequencing, so they can decide     whether to join studies that use it.      Eligibility:        -  Adults at least 18 years old who are enrolled in a National Institutes of Health (NIH)          study that uses WES/WGS.        -  Adults at least 18 years old whose children are enrolled in an NIH study that uses          WES/WGS.      Design:        -  Participants will take part in the study either in person or over the phone.        -  Participants will review two sequencing consent forms with a genetic counselor.        -  Before and after meeting with the counselor, participants will answer several questions          about sequencing. Each questionnaire will take about 15 minutes.        -  Six weeks later, participants will answer questions about sequencing. This will take          about 15 minutes.   "
103776|NCT01927757|"     To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis     (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their     first biologic agent.   "
103777|NCT01927744|"     The goal of this clinical research study is to learn if adding erlotinib to a standard     chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control     SCCHN. The safety of this drug combination will also be studied.      In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks     like the study drug but is not designed to treat any disease or illness. It is designed to be     compared with a study drug to learn if the study drug has any real effect.   "
103778|NCT01927731|"     The goal of this clinical research study is to learn if taking Promacta (eltrombopag) will     help your platelet count improve faster after your stem cell transplant. The safety of this     drug will also be studied.   "
103779|NCT01927718|"     The goal of this clinical research study is to learn if adding low dose Thalidomide     (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an     autologous stem cell transplant. Researchers also want to learn if treatment with these study     drugs will improve participants' quality of life.   "
103780|NCT01927705|"     The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with     over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of     phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj.     by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately     subacute and chronic Atopic Dermatitis.   "
103781|NCT01927692|"     The primary objective of the study is to longitudinally profile immunoglobulin levels and     autoantibody levels in subjects with myasthenia gravis (MG) who receive therapeutic plasma     exchange (TPE).   "
103782|NCT01927679|"     The main objective of the study is to assess the efficacy of an antioxidant in preventing     pigmentation induced by visible light in subjects with a phototype IV or V.      Patients will be exposed to a range of visible light to areas on the back to confirm study     eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible     to continue.      Eligible patients will have study product applied to part of the back and placebo on another     part of the back. The placebo area will be exposed to the same range of light based as at Day     -7. The area where the antioxidant is applied will have a higher range of light exposure than     the area without the study product.      Seven days later, the areas will be examined to determine the lowest exposure inducing     pigmentation on the sides with placebo and with antioxidant. The color will also be measured     between two identical exposures with placebo and with antioxidant.   "
103792|NCT01927549|"     The study compares the therapies of instant multivessel balloon angioplasty plus stent     implantation or the balloon angioplasty plus stent implantation of the infarct artery alone     with any possible graduated later treatment of the other vessels in patients with acute     myocardial infarction with cardioganic shock.      The main study hypothesis is to explore if culprit vessel only PCI with potentially     subsequent staged revascularization in comparison to immediate multivessel revascularization     by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces     the incidence of 30- day mortality and/or severe renal failure requiring renal replacement     therapy.   "
104140|NCT01922999|"     The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD     patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic     episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients     with sleep disordered breathing.   "
103784|NCT01927653|"     The hypothesis tested if the diffusion properties in the base line, such as mean diffusivity     or kurtosis, can differentiate two subtypes of MCI and predict the clinical outcome in     Patients. The hypothesis further supports the correlation of the measured diffusion     properties and the disease severity. We therefore proposed to investigate the potential value     of diffusion properties as a possible tool to monitor the disease progression. The disease     related changes in neural connectivity will be investigated.        1. The diffusion MRI could provide an improved diagnosis of Alzheimer's Disease and Mild          cognitive Impairment.           Explanation:           The deposition of the macromolecules such as beta amyloid in the brain and the          associated neuron death of the patient could lead to observable changes in tissue          microenvironment. The related changes would lead to alterations in either the amplitude          or distribution of water diffusion. In turn it could be detected in diffusion tensor and          kurtosis.        2. aMCI is a preclinical state of AD and dMCI is from a different etiology, which can be          differentially diagnosis by MRI. Diffusion Imaging could help to predict the clinical          outcome Explanation   "
103785|NCT01927640|"     This study will use myocardial contrast echocardiography performed during a continuous     intravenous infusion of Definity microbubbles (Perflutren lipid microbubbles) to determine if     dexmedetomidine (an intravenous central sympatholytic drug) can reverse all the     cardiovascular effects of low-dose intranasal cocaine—including vasoconstriction in the     coronary microcirculation—both in cocaine-naïve and non-treatment seeking cocaine-addicted     subjects.   "
103787|NCT01927614|"     Cardiac allograft vasculopathy (CAV) is a process of both immune and non-immune mediated     thickening of the heart arteries of transplanted hearts. CAV limits the long term survival of     heart transplant patients and is one of the common causes of death in the late post     transplant period. Current methods of detecting CAV rest with invasive cardiac     catheterization which carry repeated risks, as this test needs to be performed periodically     through the life of a heart transplant patient. Traditional methods of coronary angiography     identify CAV late in its course and is a crude method of evaluating coronary anatomy in heart     transplant patients. Intravascular ultrasound is an additive tool that is able to detect     early CAV before it becomes angiographically apparent, but still requires invasive cardiac     catheterization to perform. However, it also limits assessment to the major epicardial     arteries and does not give any information regarding the smaller branch vessels and cardiac     microvasculature. Advances in cardiac CT and cardiac MRI hold potential to evaluate for CAV     non-invasively. In addition, perfusion techniques may provide additional functional     information regarding the status of the microvascular.      In this pilot study, we aim to demonstrate the feasibility of cardiac CT and cardiac MRI with     and without perfusion protocols, in patients post-heart transplant and to describe and     compare CT and MRI findings in patients with established CAV versus those with no CAV, as     diagnosed by standard invasive methods.   "
103788|NCT01927601|"     The investigators seek to determine the feasibility of assessing neurologic injuries     subsequent to transcathether aortic valve replacement (TAVR). Such a model has been applied     previously by the principal investigator to assess and improve neurologic outcomes for other     cardiac surgical procedures. The investigators shall assess patients during the following     intervals: pre-procedure, within 72-96 hours post-procedure, and 3 months post-procedure.     Case videos will be established to assist in identifying and associating emboli (using     transcranial Doppler) and processes of clinical care during the TAVR procedure. Neurologic     injury will be assessed in the following ways: stroke (neurologic exam, NIH Stroke Scale),     silent infarcts (diffusion-weighted MRI, diffusion-tensor imaging), and neurobehavioral     deficits (a battery of neuropsychological tests). Secondly, the investigators will     investigate changes in the apnea-hypopnea index (AHI), a measure of sleep-disordered     breathing, before vs after surgery between those subjects who develop post-operative acute     brain infarction and those who do not. The investigators hypothesize that subjects who     develop acute brain infarction will have an increase in AHI between baseline and post-op     measurements compared with those subjects who do not develop acute brain infarction. A     research coordinator will coordinate the testing.   "
103789|NCT01927588|"     CMV infection is common in transplant patients and can cause graft loss. CMV is a major     factor in increasing morbidity, and post-transplant costs. The CMV infection is associated     with many deleterious indirect effects including rejection, interstitial fibrosis and tubular     atrophy, mortality. In addition to the potential for undesirable clinical outcomes associated     with CMV, there is also a negative economic aspect. Patients who developed CMV events have     been found to use significantly more inpatient and outpatient resources than patients without     CMV disease. Universal prophylaxis is associated with high treatment cost and the potential     for drug-related toxicity. It can be speculated that use of EVR may offer additional economic     benefits in terms of decreased utilization associated with prevention of CMV disease, and     reduce use of costly prophylaxis. Any efforts to reduce costs in renal transplants are very     important and may have a great impact in total cost of a renal program. And the other hand,     the clinical data suggest that EVR is associated with a decrease in CMV incidence compared to     mycophenolic acid (MPA). CMV replication is dependent upon 1 ou 2 mTor pathways and in vitro     studies support an association between mTor inhibitors and decreased CMV infection and     disease. In cardiac transplantation, the use of EVR was associated with a lower incidence of     CMV events. Some clinical trials data have also shown that use of EVR was associated with a     lower incidence of CMV infection compared to MPA following renal transplantation. Brennan et     al compared the incidence of CMV in three clinical trials using EVR versus MPA in De Novo     renal transplants. They pooled for analysis the studies B201, B251 and A2309, all     double-blind, randomized, parallel-groups that compared the incidence of freedom form and     incidence of CMV between EVR groups and MPA groups. The results of this pooled analysis of     over 2000 patients de novo renal transplant demonstrated that EVR was associated with a     decrease in and delay in the time of onset of CMV events compared to MPA. Our hypothesis is     that basiliximab in combination with low dose tacrolimus, everolimus and prednisone may     result in comparable efficacy (BCAR) observed in patients receiving     tacrolimus/mycophenolate/prednisone but with a better safety profile (CMV infection) and     cost-effectiveness.   "
103790|NCT01927575|"     To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can     replace or compliment current imaging standards to assess patients with hip, wrist or tibia     injuries.   "
103791|NCT01927562|"     The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal     Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.   "
138136|NCT01475643|"     The objective of this study is to compare the efficacy and safety for the treatment of     postoperative inflammation following ocular surgery for childhood cataract.   "
103793|NCT01927536|"     The investigators are testing a Light-emiting Diode (LED) flashlight from First-Light™ USA     called the Tomahawk MC Tactical Light to determine the range of colors people are able to see     with these flashlights at night. The flashlight has been designed to reduce visibility of the     user and uses a combination of green and red LED lamps to achieve this. In this study     investigators wish to determine how well a subject can differentiate colors at night in a     quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which     requires the user to put shades of red, green, blue and yellow into progressive color order     which is scored according to the manufactures specifications.   "
103794|NCT01927523|"     The purpose of this study is to learn more about the most cost-effective way to improve the     long-term life outcomes of disadvantaged youth, by comparing best practice academic supports     to best-practice non-academic supports, and learning more about whether investing in both     simultaneously has synergistic (more than additive) effects.   "
103795|NCT01927510|"     Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their     care. They develop muscle weaknesses even after only a few days of mechanical ventilation     that may prolong their time in ICU and in hospital, delay functional recovery and delay their     return home and to work. Weakness may be avoided with simple strategies of early exercise in     ICU. This pilot study aims to test the hypothesis that early mobilisation may improve     functional recovery in this patient group and gather pilot data to support a larger     randomised trial across Australia and New Zealand.   "
103807|NCT01927354|"     Investigation of the molecular mechanism and clinical significance of the interplay between     Twist1 and other EMT regulators through microRNA-29 family.   "
103808|NCT01927341|"     The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to     assess the anti-tumor activity of MEK162 in combination with panitumumab.   "
116796|NCT01757145|"     The purpose of this study is to determine whether Eltrombopag may shorten time to platelet     engraftment after allogeneic cord blood transplantation.   "
103796|NCT01927497|"     Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal     cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of     positive margins and improves oncological outcome in distal rectal cancer. However, wider     excisions increase wound healing problems and development of perineal hernia. This has     resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes     associated with a substantial increase of costs, which is not supported by proper data.      Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor     reconstruction using a biological mesh after standardized eAPR with neo-adjuvant     (chemo)radiotherapy.      Study design: This is a multicenter study in which patients undergoing an eAPR are randomized     between standard care using primary closure of the perineum and the experimental arm with     assisted closure using a biological mesh.      Study population: Patients with a clinical diagnosis of primary rectal cancer who are     scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients     will be randomized.      Intervention: The intervention in the experimental arm consists of suturing a biological mesh     derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar     to the control arm.      Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated     perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints     are hospital stay, incidence of perineal hernia, quality of life, and costs.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Both primary perineal closure and biological mesh assisted closure are being     performed in daily clinical practise. The potential benefit resulting from participation of     the study in patients randomized for biological mesh assisted closure may be a higher chance     of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand,     the use of a biological mesh has been associated with increased postoperative pain and seroma     formation.   "
103797|NCT01927484|"     Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently     exists. Synovitis is commonly demonstrated in knee OA imaging. Synovial inflammation due to     the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease     synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.      The aim of the present study is to assess the efficacy of MTX in decreasing pain and     inflammation in symptomatic knee OA.      Methods: One hundred and forty-four patients with American College of Rheumatology (ACR)     clinical and radiographic criteria of primary knee OA with knee pain, [>4 on the 24-hour     average pain severity scale (0-10) using mean of daily ratings from week preceding     randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be     included in this randomized double-blind placebo-controlled trial. Patients meeting the     eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX     (n=72) or placebo (n=72) together with their usual therapy provided the dosages were kept     constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS,     0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster     Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.     Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability     will also be assessed. Synovitis will be detected by ultrasound imaging.   "
103798|NCT01927471|"     The investigators would like to determine how aspects of metabolism and age influence ovarian     function. The purpose of the study is to understand how nutrition and metabolism relate to     follicle development in women with regular cycles, irregular cycles, or polycystic ovary     syndrome (PCOS). We also plan to identify lifestyle factors associated with PCOS and     understand how diet and activity levels impact features of PCOS.   "
103799|NCT01927458|"     The purpose of this study is to determine if transcranial direct current stimulation     (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is     effective for improving gait in patients with subacute stroke and to evaluate the effect and     predictive value of a single session of anodal tDCS.   "
103800|NCT01927445|"     The objective of this project is to increase the proportion of patients with AF that receive     adequate stroke prevention therapy. Over half of patients with AF who suffer strokes are     permanently disabled. Yet there remains a large portion of patients who do not receive     appropriate stroke prevention therapy. The investigators hypothesize that a toolkit of     quality improvement strategies in primary care could increase the proportion of patients with     atrial fibrillation appropriately treated with stroke prevention therapy. The investigators'     goal is to ensure the toolkit of interventions can be easily incorporated into day-to-day     practice in primary care and can be readily and broadly disseminated if successful.   "
103801|NCT01927432|"     In women with regular menstrual cycles, antral follicles have been shown to grow in     synchronous cohorts, called waves, 2-3 times in a menstrual cycle. It is unknown whether     these waves of follicle growth also occur in women with amenorrhea or if there is     abnormal/absent follicle growth. Further, oligo- or amenorrhea has been associated with     metabolic disturbances, such as over- or under-nutrition, central obesity and insulin     resistance. Yet, mechanisms whereby metabolic factors influence folliculogenesis in women are     poorly understood. To understand potential mechanisms, the investigators plan to characterize     follicle growth dynamics in women with or without regular menstrual cycles and identifying     key metabolic differences in these women which may be important in normal follicle     development and fertility.   "
103802|NCT01927419|"     The primary purpose of this study is to compare the objective response rate, as determined by     investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in     patients with untreated, unresectable, or metastatic melanoma   "
103803|NCT01927406|"     The purpose of this study is to evaluate the potential secondary beneficial effect of     prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims     to determine if PA would change the course of the orbitopathy in TED patients by altering the     progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid     retraction and optic nerve compression. The eyes with thyroid eye disease and elevated     intraocular pressure will be randomised to the PA treatment and the other eye will serve as a     control eye and will be treated with Timolol.   "
103804|NCT01927393|"     This randomized clinical trial studies palliative care in improving quality of life and     symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may     help patients with advanced pancreatic or ovarian cancer live more comfortably.   "
103805|NCT01927380|"     The purpose of this study is to measure the variations of autonomic nervous system (ANS)     modulation directed to the heart and vessels induced by pneumoperitoneum and steep     trendelenburg position.   "
103806|NCT01927367|"     Research Question: Among community-based patients with AF, does providing an integrated     Clinical Decision Support System (CDSS) to providers and patients improve process of care and     clinical outcomes, and decrease the healthcare costs and resource utilization over 12 months,     as compared to usual care?      Intervention: A web-based clinical decision support system, computerizing the Canadian AF     clinical guidelines, to support primary care providers and patients in optimizing and     standardizing AF care.   "
103809|NCT01927328|"     40 eligible patients with confirmed esophageal or gastric adenocarcinoma and anemia will be     randomized to a control or intervention group for management of this anemia. The control     group treatment will consist of standard treatments as governed by the clinical team (eg oral     iron, blood transfusions) whilst the intervention group will be treated with intravenous iron     III isomaltoside (Monofer ®).      It is hypothesized that intravenous iron supplementation is more efficacious than standard     therapies.   "
103810|NCT01927315|"     Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the     development of diabetic retinopathy are incompletely understood and include alterations in     bone marrow derived vasculogenic cells called endothelial progenitor cells.      Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and     hypertriglyceridemia. In a trial conducted in type 2 diabetic patients, the drug fenofibrate     has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the     mechanisms that drive the development of this complication.      Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC     levels in diabetic patients with retinopathy, compared to placebo.   "
103811|NCT01927302|"     The purpose of this study is to investigate the effects of treatment for specific language     deficits in people with aphasia. In addition to language and cognitive measures, changes in     brain function will also be gathered before and after the treatment is administered in order     to track any changes resulting from receiving treatment.   "
103812|NCT01927289|"     This is a double-blind prospective randomized control trial. The primary hypothesis is that     the preservation of motor function is superior in distal forearm blocks compared to     supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's     satisfaction, rate of block success, onset and duration of block.   "
103813|NCT01927276|"     Out of 300 million persons in the United States, about one-half of one percent, or 1.5     million, have a diagnosis of schizophrenia. Schizophrenia begins in young adulthood, and     often is chronic and disabling for the remainder of the life course], which is shorter than     for the general population by as much as 25 years. The costs of schizophrenia in the United     States are estimated to be between $30 and $60 billion dollars annually. Treatment for     schizophrenia is only marginally successful: in the Clinical Antipsychotic Trials of     Intervention Effectiveness (CATIE), for example, the medication prescribed at the beginning     of the trial was stopped or changed in nearly 75% by the completion of the trial 18 months     later. The medications have limited effect on negative symptoms or cognitive impairments of     schizophrenia, and many have severe and permanent side effects. The basic hypothesis     underlying treatment for schizophrenia has not changed for more than half a century. New     treatments are needed.      Much accumulating evidence suggests that sensitivity to gluten may be related to symptoms or     etiology in schizophrenia and that gluten free diets may lead to significant symptom     resolution, but only in patients who are known to have antibodies to gluten.      Gluten sensitivity may be more common than thought and stems from a different etiology and     symptom presentation than Celiac Disease. The investigators analysis of the CATIE sample show     that about 23% of persons with schizophrenia (compared to 3% of healthy controls) have Gluten     Sensitivity (about 300,000 persons in the United States) through the identification of     gliadin positive antibodies in their blood. The investigators hypothesize that people with     this biomarker could have robust symptom improvements with the removal of the antigen from     the diet (gluten). If only half of people with schizophrenia and these antibodies were to     substantially benefit from removal of gluten from the diet, as in the case studies and with     certain subjects in the clinical trials, this would provide a new transformative treatment     option for an identifiable subpopulation of people with schizophrenia and would be of     enormous benefit to patients, families and society. Another benefit to the public's health     from this study will be enhanced knowledge of the etiology of schizophrenia, including     possible linkages between neuropsychiatric disease and immune system activation, and     identification of novel, immune-linked treatment targets.      The results of this research could lead to screening for Anti-Gliadin Antibodies early in     life or at the first episode of schizophrenia, as recommended by some already. Screening     involves financial and emotional costs, and better evidence is needed before this     recommendation can be justified. Moreover, a new treatment paradigm of removing gluten from     the diet by means of gluten blocking medications (already in early study) could advance     treatment significantly.      This study will test the efficacy, in a pilot fashion, of 20 participants in a double blind     five week randomized placebo controlled gluten free diet vs identical diet with gluten in     gliadin-positive individuals with schizophrenia. Approximately equal numbers will receive the     addition of gluten, or non-gluten starch, in identical form (given as flour in food). The     investigators plan to develop mechanisms and procedures to locate, screen, and recruit     subjects into the inpatient intervention study, retain them during the inpatient phase. Once     admitted baseline assessments may take approximately a few days but will be mostly completed     in the first week prior to the 5 week randomization, thus patients may stay longer than 5     weeks. At the end of the double blind trial the investigators will prepare for discharge and     then test the feasibility of successfully maintaining gluten free diets after the     intervention phase is complete, for at least two months.   "
103814|NCT01927263|"     The purpose of this study is to investigate similarity between NI-071 and infliximab(the     comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately     responding to Methotrexate.   "
103815|NCT01927250|"     The purpose of this study is to determine whether multi-dimensional wellness program (diet,     art and biofield therapy) influences the quality of life for those with different health     status in Japan.   "
103816|NCT01927237|"     The purpose of this protocol is to perform serial physiological measurements and blood     testing on mechanically ventilated patients comparing conditions of eucapnia and hypercapnia     in the same patient. We will be testing two hypotheses: (1) while administering inspired     carbon dioxide (CO2), eucapnia achieved by high respiratory rate (EHR) significantly     decreases pulmonary artery pressures compared to hypercapnia with a lower respiratory rate     (HLR), and (2) that EHR decreases myocardial strain compared to HLR.   "
103817|NCT01927224|"     This study will evaluate the bioequivalence as well as safety and tolerability of a novel 30     mg tablet of nifurtimox compared to the corresponding marketed 120 mg tablet in adult     subjects suffering from chronic Chagas' disease when administered after a high-fat /     high-calorie test meal. This study is a necessary step for the development of an age     appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic     countries according to the recommendations provided by current international guidelines (EMA     Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage     Forms).   "
103818|NCT01927211|"     The study will investigate whether the placement of silver plated dressings beginning in the     OR will improve wound healing in patients undergoing cesarean delivery compared to     traditional Telfa pads. This study will also explore the presumed improvement in scar     integrity when silver plated dressings are used compared to Telfa pads. The study will     examine post-operative pain by review of anesthesia and analgesic use during hospitalization     and scar-related pain scores at the post-operative visits.      The study will compare the percentage of patients who develop a surgical site infection after     application of silver plated dressings versus standard Telfa dressings. Investigators will     also assess the cosmetic appearance of the cesarean section scar at the patient's one week     and 6 wekk post-operative visits.   "
103819|NCT01927198|"     This study will assess the serum uric acid lowering effects and safety of 3 dose levels of     RDEA3170 compared to placebo in subjects with gout.   "
103862|NCT01926639|"     Patients with non-curable disseminated follicular lymphoma receive local radiotherapy     targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous     dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to     induce tumor immunity and clinical responses.   "
103820|NCT01927185|"     Central venous catheterization is commonly applied in patients undergoing cardiac surgery.     The subclavian vein has lower risk of infection and provides more patients comfort. However     central venous catheterization may results in complications such as pneumothorax, hemothorax     or arterial puncture. It has been suggested that ultrasound (US) guidance could improve the     success rate, reduce the number of needle passes and decrease complications. Two different     real-time 2-dimensional US techniques can be employed in the insertion of central venous     catheters. The first technique involves real-time US-guided cannulation of subclavian vein     using a long axis/in-plane approach. The second one involves real-time US-guided using a     short axis/out-off-plane approach. However to date no studies have compared their efficacy     and safety. The purpose of this study was to compare the US-guided long-axis versus     short-axis approach for the SCV catheterization in adult critical care patients.   "
103821|NCT01927172|"     The purpose of this study is to determine if the AirSonea device provides an objective     assessment of breath sounds for the presence of wheeze in both medical and home environments.   "
103822|NCT01927159|"     The purpose of this study is to determine the safety, tolerability, and immunogenicity in     BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the     prevention of pulmonary tuberculosis.   "
103832|NCT01927029|"     Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit     of progesterone in this population. In contrast, singleton pregnancies are treated with this     hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with     placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each     group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.   "
103823|NCT01927146|"     By literature review, there is a clear trend towards a potential role for human epidermal     growth factor receptor 2 (HER2) as a negative prognostic factor in gastric cancer was shown,     but only in half of the analyses used multivariate statistics. Besides, For the studies in     the current review that have looked at the Lauren classification in relation to HER2, a     higher level of overexpression or amplification was found in the intestinal phenotype     compared to the diffuse or mixed types. As lauren classification was reported as an     independent prognostic factor result in favored outcomes in gastric cancer (GC), there may     probably be histologic bias exists when compare overall survival (OS) between HER2 statuses     without controlling this confounding. Similarly, patients with different disease settings     (early stage and advanced stage; resectable and metastatic) affect outcomes either.      In this study, the investigators will retrospectively analyze HER2 status and lauren     classification in 800 gastric patients who received gastrectomy in the Cancer Center of Sun     Yat-Sen University between January 1996 and December 2006 with formalin-fixed and paraffin-     embedded tumor tissue samples. To avoid potential influence by histologic classifications and     disease settings, the investigators assess difference in OS between HER2 positive and HER2     negative groups in resectable Lauren classification of GCs, and further evaluate the     prognostic value of HER2 status according to tumor-node-metastasis (TNM) stages.   "
103824|NCT01927133|"     Mortality related to complications of cirrhosis, (hemorrhage, hepatic insufficiency and     primary liver cancer) is 15,000 per year in France. These mortality increases, despite that     advanced fibrosis can be identified by non-invasive biomarkers and treated, more than 10     years before the onset of complications and cancer. The main goals of the FIBROFRANCE project     which started in 1997 (initially called the MULTIVIRC group) were to demonstrate the     performance of serum biomarkers in the more frequent chronic liver diseases, to estimate the     dynamic of fibrosis progression and finally to demonstrate the feasibility of the fibrosis     screening in French people.      The different cohorts of the FIBROFRANCE (HCV, HBV, ALD, NAFLD) permitted many publications     among the 186 publications of our group since 1986 in the field of liver fibrosis. These     publications included discovery and validation of non-invasive biomarkers (Poynard     Gastroenterology 1997, Imbert-Bismut Lancet 2001, Poynard BMC Gastro 2007), modelling     fibrosis progression or regression (Poynard Lancet 1997, Poynard Gastroenterology 2002,     Poynard J Hepatol 2003) and fibrosis screening (Ratziu APT 2007, Jacqueminet Clin     Gastrenterol Hepatol 2008). This research was conducted in Pitié-Salpêtrière hospital for the     biochemical and clinical part in connection with national and international networks. Several     panels have been identified and the most predictive FibroTest has been patented (US Patent     Office 6.631.330) and launched in 2002. This is the first fibrosis biomarker available     worldwide (50 countries including USA as FibroSURE) with more than 1 million prescriptions     between 2002-2013. FibroTest, has been validated first in hepatitis C and then in hepatitis B     alcoholic liver disease and metabolic syndrome. Therefore it is now possible to screen     advanced fibrosis in the 4 most frequent liver diseases: alcohol, hepatitis C and B, and     metabolic syndrome (diabetes, overweight, and hyperlipemia). For all the patients detected     there are therapeutic options to cure the fibrosis or to reduce the progression to cirrhosis     and cancer.      FibroTest has been recommended as alternative to biopsy in several guidelines (AFEF, APASL,     EASL and CASLD) and more recently in US overview (Chou Annals 2013). It reimbursed in France     in chronic hepatitis C. Several factors of fibrosis progression can be present in the same     subject, i.e. an overweight and an excessive alcohol consumption. Therefore no realistic     screenng strategy can be conducted without taking into account the Interdependence of the     different risk factors. Three biomarkers of fibrosis-associated liver injuries have been     developed and validated in FIBROFRANCE cohorts: SteatoTest for steatosis (Poynard Comp     Hepatol 2005), NashTest for non-alcoholic steatohepatitis (Poynard EASL 2006), and AshTest     for alcoholic steatohepatitis (Naveau J Hepatol 2006). For this purpose different cohorts     already used for diagnostic validation will be followed at long term for prognostic     validations: FIBROFRANCE-ALD (Naveau Hepatology 2010), FIBROFRANCE-NAFLD including     dyslipidemia cohort (Ratziu APT 2007) and diabetes cohort (Jacqueminet Clin Gastrenterol     Hepatol 2008). These cohorts will allow assessing the prevalence of fibrosis and the specific     risks of fibrosis progression imputable to steatosis and steatohepatitis.   "
103825|NCT01927120|"     IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with     Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus     host disease (GVHD).   "
103826|NCT01927107|"     The global obesity epidemic presents an unprecedented challenge to the public health     worldwide. The factors associated with obesity are complex, and include health behaviors,     such as eating habits and daily physical activity, and broader social, environmental and     biological determinants that influence these health behaviors. The intestinal microbiota has     several beneficial functions related to host health and accumulating evidence indicates that     the gut microbiota plays a significant role in the development of obesity, obesity-associated     inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of     Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota     and, probably, the way individuals harvest energy from nutrients. Differences in community     composition, functional genes and metabolic activities of the gut microbiota appear to     distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the     development of obesity and/or its complications.      Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on     obesity and metabolic syndrome in adults; such experience is limited in children and     adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to     standard therapy on anthropometric measurements, lipid profile and oxidative stress     parameters in children.   "
103827|NCT01927094|"     -  Acute diarrhea continues to be a major cause of childhood morbidity and mortality in          developed and developing countries.        -  Prevention and treatment of dehydration are the mainstays of therapy. Rehydration can be          achieved with oral rehydratation solution (ORS).        -  Even though ORS has reduced the mortality and morbidity very significantly, it has no          effect on the duration of diarrhea, stool consistency and frequency and remains          underused.        -  ESPGHAN and ESPID published together an evidence based guideline and stated that in the          management of acute gastroenteritis rehydration is the key treatment and that selected          probiotics may reduce the duration and intensity of symptoms and can be used as an          adjuvant to ORS.        -  Current evidence also indicates that probiotic effects are strain-specific.          Lactobacillus GG and Saccharomyces boulardii are the best studied strains. However, more          research is needed to guide the use of particular probiotic regimens and strains and as          there is still no evidence of efficacy for many preparations.   "
103828|NCT01927081|"     The purpose of this research study is to evaluate whether self-management discussion groups     are helpful for women with advanced breast cancer who are experiencing pain. The study is     looking at the usefulness of two different types of discussion groups, one of which also     includes gentle exercise.   "
103829|NCT01927068|"     Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of     the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter in the treatment of     de novo or restenotic lesions in the superficial femoral and/or popliteal arteries Cohort 2:     To evaluate this patient population for treatment of in-stent restenotic lesions   "
103830|NCT01927055|"     Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week     (maximum) treatment period in patients with symptomatic NOH.   "
103920|NCT01925885|"     -  Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or          eliminate clinical atrial fibrillation in subjects with accepted indications for          catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.        -  Summary: This is a prospective randomized study to assess the safety and effectiveness          of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for          the treatment of symptomatic paroxysmal atrial fibrillation.   "
103831|NCT01927042|"     Family therapy is considered an empirically supported treatment approach for adolescents and     adults with eating disorders. One family based approach, Expert Carers Helping Others (ECHO)     is based on evidence that suggests family environment, e.g., carer criticism, can influence     an individual's eating disorder symptoms. ECHO aims to improve carer coping, reduce expressed     emotion and manage eating disorder symptoms, and has been associated with reduced carer     distress, caregiver burden, and an increase in general well being. The current pilot study     seeks to evaluate a new condensed version of the ECHO intervention that is delivered entirely     in a 2 ½ hour self-help DVD format (ECHOs). Sixty patients and their carers will be recruited     from the Capital Health Eating Disorders Service and randomized into either a treatment as     usual group (TAU) or a TAU+ECHOs group. Both carers and patients will be assessed along a     variety of dimensions including psychiatric symptoms, family functioning, and carer and     patient collaboration, at pre-intervention, four weeks later at post-intervention, and then     three-months post-intervention. ANOVAs will be used to compare the primary outcomes between     the two groups over time. This pilot study will be the first evaluation of ECHOs, which may     ultimately boost the efficacy of current treatment for adults with eating disorders and     reduce carer distress.   "
103833|NCT01927016|"     Background        -  Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the          eighth most common cancer worldwide        -  The incidence is increasing rapidly        -  The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes          are related to diagnosis at advanced stages.        -  Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but          treatment of esophageal carcinoma remains challenging and need to be considered through          a multimodal approach. However the modalities and the impact of this multimodal approach          at a national level are unknown Primary objective: To identify predictors of recurrence          after esophageal cancer surgery      Secondary objectives :        -  5-year recurrence free survival        -  5-year overall survival        -  Predictors of postoperative mortality and morbidity after surgery        -  Impact of pCR on recurrence and survival        -  Impact of neoadjuvant treatments on recurrence and survival        -  Impact of patient preconditioning (such as nutritional support, esophageal prosthesis,          mini-invasive approach…) on outcomes      Methodology : European French-speaking retrospective multicentric study Inclusion criteria:     All consecutive patients operated on, for a histologically proven carcinoma of the esophagus,     the oesophago-gastric junction (Siewert type I and II), in surgical investigator centers     between January 2000 and December 2010 Exclusion criteria: Siewert III type carcinoma of the     oesophago-gastric junction , non surgical treatment of esophageal carcinoma Planned study     period: The data will be collected over a 11-year period from January 2000 to December 2010.     Follow up will be ascertained in May 2013.   "
103834|NCT01927003|"     Multiple digital injuries are often complex and severe, and the commonly used local and     regional flaps may not be feasible. The authors reconstruct soft tissue defects of the     fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.   "
103835|NCT01926990|"     This pilot clinical trial studies perfusion computed tomography (CT) in predicting response     to treatment in patients with advanced kidney cancer. Comparing results of diagnostic     procedures done before, during, and after targeted therapy may help doctors predict a     patient's response to treatment and help plan the best treatment.   "
103836|NCT01926977|"     This study is designed to compare the post injection inflammation and pain seen after     intravitreal injections of Ranibizumab vs Aflibercept.   "
103837|NCT01926964|"     Oncotype DX® is likely to become more widely used in Europe as well as in Switzerland. The     test is currently not reimbursed by the Swiss health insurances.      The proposed study will investigate to what extent adjuvant treatment recommendations in     breast cancer patients with an ER-positive tumor, made by Swiss tumor boards, are based on     conventional factors, and whether the recommendations would change, when RS results from the     Oncotype DX® test were available.      In addition this study approaches the dilemma of adding adjuvant CT to adjuvant endocrine     therapy in a systematic fashion. In this study, the St. Gallen consensus 2009 (with a minor     update from the 2011 consensus, is used to predefine the patients suitable for endocrine     therapy or chemo-endocrine therapy. Once results of this study are available they may help to     better integrate Oncotype DX® with other factors. Currently, it is unclear how the different     factors should be integrated into one recommendation.      This study will provide data on the usefulness of this test for the two patient groups which     are suitable for hormone therapy only and for those who are considered for hormone plus     chemotherapy.   "
103838|NCT01926951|"     This study will evaluate the effects of renal denervation using externally focused     therapeutic ultrasound with external targeting and tracking on patients with refractory     hypertension.   "
103839|NCT01926938|"     Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk     for type 2 diabetes. The function of the endothelium has played a key role in the     understanding of vascular complications in people with diabetes. Endothelial function and     vascular reactivity are impaired not only in white adults with type 2 diabetes but also in     those at risk for the disease by virtue of having impaired glucose tolerance or parental     history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The     investigators plan to assess the endothelial function and vascular reactivity in young     Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging     to a minority population.   "
103921|NCT01925872|"     1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.        2. Genetic polymorphisms are the most important factors to clopidogrel resistance.        3. The purpose of this study is to find the genes which are the related to clopidogrel          resistance.        4. Through gene sequencing, we can filter patient of clopidogrel resistance, so another          drug maybe used to avoid the undesired efficacy.   "
103840|NCT01926925|"     Type 2 diabetes is now more frequent in children/adolescents, especially in those from     minority populations, including Hispanic Americans (HA). Diabetes and the pre-diabetes state     markedly increase the risk of cardiovascular disease. Endothelial dysfunction is seen in the     earliest stages of atherogenesis, which ultimately leads to cardiovascular disease. The main     aim of this study is to evaluate the endothelial function in HA children/adolescents who are     at risk for developing type 2 diabetes (obese children/adolescents from the Hispanic     population).      The investigators' hypothesis is that endothelial dysfunction is present in this population     and that it is associated with metabolic abnormalities linked to the insulin resistance     syndrome. The investigators will study 2 groups of 15 individuals each, age 10-18 years.     Group 1 will consist of obese (body mass index greater than 85th percentile for age and sex)     Hispanic American children/adolescents and group 2 will consist of healthy, non-overweight     (body mass index between the 25th and 50 th percentile for age and sex) Hispanic American     children/adolescents.      The study will be carried out at the Joslin Diabetes Center. During the first day,     participants will have a medical history and full physical examination, a standard OGTT and     measurement of blood cell count, plasma glucose, insulin, lipids, HbA1c, BUN, creatinine,     electrolytes, estradiol, testosterone, free fatty acids, CRP, endothelial markers, urinary     microalbumin and hCG, if appropriate. An OGTT will be performed in order to rule out IGT or     Diabetes. Estimations of insulin secretion and insulin sensitivity will be assessed using the     homeostasis model assessment (HOMA). In the second day, the body composition and the brachial     artery vasodilatory response to hyperemia will be assessed. Those found with diabetes will be     tested for GAD-65 and IA2.      The investigators' hypothesis is that Hispanic American children/adolescents at risk for type     2 diabetes have impaired endothelial function and vascular reactivity that are associated     with the degree of insulin resistance and its metabolic abnormalities.   "
103841|NCT01926912|"     The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate     use and pattern of paliperidone palmitate usage in participants with schizophrenia in the     hospital setting.   "
103842|NCT01926899|"     The objective of this study is to determine the maximum tolerated dose (MTD) of bortezomib in     combination with calcineurin inhibitor and methotrexate as acute graft versus host disease     (aGVHD) prophylaxis in pediatric patients undergoing allogeniec hematopoietic stem cell     transplant (alloHSCT)   "
103843|NCT01926886|"     This single arm, multicenter study will evaluate the safety of assisted subcutaneous     administration of Herceptin (trastuzumab) in patients with HER2-positive early breast cancer.     Patients who have completed the first 6 cycles of intravenous Herceptin as part of the     (neo)adjuvant treatment will be eligible to receive a further 12 cycles of Herceptin in this     study. For the first 3 cycles, Herceptin will be administered intravenously (6 mg/kg) at the     hospital. The next 3 cycles, Herceptin (600 mg every 3 weeks) will be administered     subcutaneously via a hand-held syringe by a trained HCP at the hospital, and for the last 6     cycles Herceptin will be administered subcutaneously via a hand-held syringe by a trained HCP     at the patient's home.   "
103844|NCT01926873|"     This multi-center screening study will conduct a cognition assessment to collect reference     data for comparison to patients with depression in healthy volunteers. Data will be collected     for 6 weeks.   "
103845|NCT01926860|"     The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will     have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13)     vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific     serum antibodies and their opsonophagocytic activity. The results of volunteers receiving     PCV13 and Epaxal will be compared to that in a control groups of adults receiving either     hepatitis A or PCV13 vaccines only.   "
103846|NCT01926847|"     Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold     causing acute lowering of blood flow through the digits. In this trial the safety and     efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood     flow will be measured during a cold exposure test in patients suffering from Raynaud's     phenomenon. Measurements of two periods will be compared: in one period the patient will be     given active drug and in the other period a placebo.   "
103847|NCT01926834|"     To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after     acute cerebral infarction,test is made by random double-blind controlled.patients with acute     cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin     group,and health people. The main indexes are the serum level of VEGF, MMP-9 and EPC.The     review is made by the reference to NIHSS and so on. So, Erigeron Injection have the function     of promoting angiogenesis in multiple targets through this test.   "
103848|NCT01926821|"     The impact of sonifilan on the quality of life in patients with cervical cancer during     radiation or chemoradiation therapy        1. Primary endpoint : Quality of life        2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan   "
103849|NCT01926808|"     The purpose of this study is to try to correlate vitamin D dosing and dosing adjustment with     Vitamin D levels, measure affects of seizure medications on levels as well as pathologic     fractures and bone density in severely cognitively impaired, non-mobile children and     adolescents with CP.   "
103850|NCT01926795|"     Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern.     Children have thickened periosteum compared with adults, which therefore may impart stability     to the fracture without the need for additional immobilization. The goal of the study is to     evaluate whether or not there is a difference in children treated with and without cast     immobilization in regards to time to ambulation; perceived pain; difficulty in dressing &     bathing; radiographic displacement or angulation; and time missed from work or daycare. Our     null hypothesis is that there will be no difference in clinical or radiographic outcomes     between the groups.   "
103851|NCT01926782|"     To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4     weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The     dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a     calibrator.   "
103852|NCT01926769|"     To determine the safety and efficacy of second-line treatment with Metformin and Chemotherapy     (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer   "
103853|NCT01926756|"     This is a prospective randomized controlled trial to look into the reduction of catheter     associated urinary tract infections in the postoperative period. It will specifically look at     short gynecologic procedures such as D&C (dilation and curettage), hysteroscopies and LEEP     procedures and the need to perform intraoperative catheterization. If a patient urinates     immediately before a short operation then there is no need to drain the bladder with a     catheter during the procedure. The investigators hypothesize that eliminating catheterization     during these short procedures may decrease postoperative urinary tract infections. The hope     is that this study would provide evidence to support a change in practice.   "
103854|NCT01926743|"     Lymph node dissection in gastric cancer surgery is a very important factor not only for exact     acquisition of stage but also proper treatment. Realistically, it is impossible to identify     complete removal of lymph node in dissected nodal station by naked eye. The investigators can     assess the route of lymphatic drainage and identify residual lymph nodes in dissected area.     In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was     used only detection of sentinel lymph nodes. However, this novel concept can help to     understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection     completely.   "
103855|NCT01926730|"     The proposed study is a randomized controlled trial of a limited restriction diet compared to     a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients     will complete a semi-quantitative food frequency questionnaire assessing usual dietary     patterns over the preceding month. Disease activity will be assessed with the abbreviated     Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed     during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the     study diets will be assessed with food frequency questionnaires (FFQs) administered after 20     weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to     relapse using Cox regression for patients in the two study arms. In the exploratory aim, we     will compare outcomes among patients in the highest tertile for other food items and     nutrients to those in the lowest tertile based on self-reported usual dietary patterns at     baseline. Thus, the study population will be analyzed both as a randomized controlled trial     and as a prospective cohort study.   "
105703|NCT01902485|"     This study will compare immediate to post-abortion start of two progestin-based     contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical     abortion who wish to use that method for post-abortion contraception.   "
103857|NCT01926704|"     Human visual acuity and contrast sensitivity are highly dependent on various different     parameters. Each should be optimized for perfect visual performance. However, in real life     our eyes lack such parameters, which might lead to unsatisfying results even after spectacle     correction or contact lenses.      A promising approach would be to design intra ocular lenses (IOL), which are implanted into     the eye for example in the course of cataract extraction and are able to compensate for the     human eyes' aberrations.      For example cutoff frequency, edge-sharpness or specific contrast for selected structure     sizes would need to be considered. Since, an aberration free optical system is almost     impossible and since the impact of each single parameter is not yet known, IOL design     parameters would have to be chosen very carefully.      Furthermore, image quality of IOLs still is tested ex vivo by ray tracing for example, but     this does not guarantee perfect function after implantation, as our visual system has complex     image precessing units form the retina to the brain.      The present study picks one of these parameters and seeks to assess its impact on visual     quality in-vivo. By subjectively grading different images with objective changes to image     quality by variations of the modulation transfer function (MTF), the potential influence and     thus on our subjective visual impression shall be assessed.   "
103858|NCT01926691|"     Background: Recent studies have demonstrated that even mild stroke survivors experience     residual damage, which persists and in fact increases in subsequent years. About 45% of     stroke victims remain with different levels of disability. While studies on cognitive     impairment and dementia after stroke are receiving increasing clinical attention, the     underlying pathophysiology is poorly understood. Identifying the mechanisms involved and     recognizing early biomarkers for individual vulnerability, require a multi-modal approach, as     the mechanisms involved in cerebrovascular disease and individual trajectories of post-stroke     recovery may impact upon each other on various levels.      Aims and Hypothesis: To date there is no single measure that can be used to identify patients     who are prone to develop cognitive impairment and other disabilities from those with better     recovery prospects.      We hypothesize that data based on biochemical, neuroimaging, genetic and psychological     measures can, in aggregate, serve as better predictors for subsequent disability, cognitive     and neurological deterioration, and suggest possible interventions.      Design: The TABASCO (Tel-Aviv Brain Acute Stroke Cohort) study is an ongoing, prospective     cohort study aim to recruit about approximately 1125 consecutive first-ever mild-moderate     stroke patients. It is designed to evaluate the association between predefined demographic,     psychological, inflammatory, biochemical, neuro-imaging and genetic markers, measured during     the acute phase, and long-term outcome: subsequent cognitive deterioration, vascular events     (including recurrent strokes), falls, affective changes, functional everyday difficulties and     mortality.      Discussion: This study is an attempt to comprehensively investigate the long term outcome of     mild-moderate strokes. Its prospective design will provide quantitative data on stroke     recurrence, the incidence of other vascular events and the evaluation of cognitive, affective     and functional decline. Identifying the factors associated with post stroke cognitive and     functional decline could potentially yield more effective therapeutic approaches.      We believe that an extensive approach of analyzing the interaction between different risk     factors would more accurately predict neurological deterioration.   "
103859|NCT01926678|"     With approximately 12 million cancer survivors today in the United States alone, increased     attention is being given to quality of life after cancer treatment. Cancer-related fatigue     (CRF) is one of the most prevalent and debilitating symptoms experienced by people with     cancer. It can persist for months or years after cancer therapy is completed and has a     negative impact on all areas of function. Meaningful evidence-based treatment options for CRF     are extremely limited and finding safe, inexpensive, and effective interventions for managing     this distressing symptom are urgently needed. Basic research has shown that activation of the     immune system can cause potent changes in behavior including reduced activity, fatigue, and     decreased social behavior. Furthermore, research over the last decade has found a     relationship between levels of CRF with increased inflammation. Thus, study of therapies that     may decrease immune system activation in the setting of CRF represents a possible target for     intervention. Massage therapy is one of the fastest growing alternative therapies and has a     high rate of acceptance for symptom management among cancer patients. Massage has been shown     in smaller studies with cancer patients to modulate the immune system. Moreover, massage has     been demonstrated to significantly decrease markers of immune system activation in normal     subjects. There are no published randomized controlled trials examining either the role of     massage as an intervention primarily for CRF or investigating whether massage related     decreases in immune system activation are responsible for improvement in CRF. This proposal     investigates the effects of massage therapy on CRF among breast cancer survivors. The     investigators' primary hypothesis is that Swedish Massage Therapy (SMT) will decrease CRF     compared to a light touch condition and wait list control. The investigators' secondary     hypothesis is that SMT will decrease CRF by reducing immune system activation. The     investigators' main exploratory hypothesis is that a decrease in CRF will increase quality of     life among cancer survivors.   "
103860|NCT01926665|"     The goal of this clinical research study is to find the highest tolerable dose of carfilzomib     that can be given to patients with lymphoma after a stem cell transplant. The safety of this     drug will also be studied.      Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells     cannot repair themselves, this may cause them to die.   "
103861|NCT01926652|"     Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of     amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with     candesartan 32mg in healthy male volunteers.   "
105224|NCT01908803|"     The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic     Suspension relative to ototopical CIPRODEX for microbiological success at Day 8 and time to     cessation of otorrhea.   "
103863|NCT01926626|"     The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A     inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This     rationale is based on several findings from previous work: 1) cigarette smoke contains     constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2)     that severity of depression symptoms after smoking abstinence is correlated with the level of     MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was     found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women     show a greater association between smoking and depression than men and women smokers in our     previous trials report smoking to alleviate symptoms of depression to a greater extent than     men.   "
103864|NCT01926613|"     The purpose of this study is help people with serious mental illness and receiving vocational     rehabilitation get and keep the job they want by improving their thinking skills, such as     attention and memory, using computer exercises and other strategies. One half of the     participants in the study will receive vocational rehabilitation and the exercises to improve     thinking skills, and the other half will receive just vocational rehabilitation. All     participants will receive an assessment of symptoms and thinking skills at the beginning of     the study and 6, 12, and 24 months later. Work activity during the 24 months in the study     will be collected. It is expected that those participants who receive the practice of their     thinking skills will be more likely to get and keep the job they want compared with people     who do not receive this treatment.   "
103865|NCT01926600|"     Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI)     among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).   "
105792|NCT01901315|"     The purpose of this project is to compare the effectiveness between face-to-face     consultations and consultations via videoconferencing among patients treated in the Institute     of Psychiatry (IPq).   "
103866|NCT01926587|"     This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II,     Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed.     The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with     azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety     of patients is an objective throughout all parts of the study.   "
103867|NCT01926574|"     Long-term sick-listing from work has considerable impact on social function, on the families     of the sick-listed persons, the companies they work for, and society as a whole. Hence, the     need for documented effective vocational rehabilitation programs is pressing. Vocational     rehabilitation services described in the scientific literature have been specific to one     single or a specific group of medical conditions (e.g.low back pain). In contrast, most     people on sick leave have several health complaints, and many of the factors influencing sick     leave are shared regardless of disorder (e.g. social surroundings, workplace environment),     calling for rehabilitation programs that can be employed for both musculoskeletal-,     unspecific- and common mental disorders. Aim of this study is to investigate whether a group     based rehabilitation program for musculoskeletal, mental or unspecific complaints can     facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW     rehabilitation programs.   "
103868|NCT01926561|"     Patients's demographics and perioperative factors affect the occurrence of hypotensive     bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting     position under interscalene block.   "
103869|NCT01926548|"     This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x     200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.   "
103870|NCT01926535|"     The amniotic membrane (AM) is an avascular structure derived from fetus, which is a good     choice for regenerative medicine and effective treatment in eye surface pathologies such as     bullous keratopathy (BK). This disease generates a chronic corneal edema evolving to the     production of vesicles and bullae, chronic eye pain and visual acuity decrease.      Definitive treatment for those patients is corneal transplant; however, donation is not     always available and thus requires long waiting times. The currently available palliative     treatment consists in the use of contact lenses to prevent the corneal epithelium from     falling. However, this may be associated with corneal neovascularization, lens displacement     or loss, infections, and discomfort for the patient.      The objective of this work was to compare the use of amniotic membrane grafts versus contact     lenses in patients suffering from BK awaiting a corneal transplant.      A randomized clinical trial assay was performed with patients with a clinical diagnosis of     BK. Twenty patients were randomized into 2 groups: amniotic membrane and therapeutic contact     lenses. Eye pain intensity (Analog visual scale), visual acuity (Snellen questioner), bullae     and corneal epithelial defects presence, as well as corneal neovascularization and     complications (biomicroscopy) were compared during 6 months.   "
103871|NCT01926522|"     The investigators evaluated the effectiveness of the application of analysing treadmill,     muscle strengthening and balance training compared to a control intervention in patients with     diabetic neuropathy.   "
103872|NCT01926509|"     This study will evaluate the safety, tolerability, and PK of MK-8892 in participants with     pulmonary arterial hypertension. The primary hypothesis is that the geometric mean of MK-8892     area under the concentration time-curve from Hour 0 to 24 hours (AUC0-24hr) in participants     with PAH, will be equal to or greater than the efficacious exposure in humans of 0.6 μM•hr.   "
103873|NCT01926496|"     The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or     other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream.     Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive     a second treatment cycle with the same treatment if the first treatment does not clear all     AKs. Subjects will be followed over a period of three year (36 months) after first treatment   "
103874|NCT01926483|"     The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial     treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate     the security of treatment, the QoL of patients and the influence to the PFS and OS.   "
103875|NCT01926470|"     Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of     lumbosacral radicular pain, but in case of intravascular injection, infrequently serious     complication can be developed. Against this backdrop, if there is any difference of frequency     of intravascular injection incidence during S1 TFESI between method in anteroposterior view     and method in oblique view using Scotty dog, the result can be crucial factor in selecting     the approach. In addition, appropriate volume of injection will be checked in each approach.   "
103876|NCT01926457|"     The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin     A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of     pregnancy, and patients will be randomized to first trimester or third trimester treatment;     the first trimester group will receive intervention immediately upon diagnosis of prediabetes     whereas the third trimester group will receive only routine prenatal care until 28 weeks at     which time they will receive intervention.      Intervention is defined as:        -  diabetes education        -  blood glucose monitoring        -  medications as needed        -  growth ultrasounds        -  antenatal testing      The primary outcome is umbilical cord C-Peptide >90th percentile. Secondary outcomes include     neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal     gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's     umbilical cord blood.      The investigators hypothesize that women who undergo the above intervention in the first     trimester will deliver significantly fewer neonates with umbilical cord C-Peptide >90th     percentile, and that the neonates will have lower fat mass, and weight-for-length at 12     months. The investigators further hypothesize that a greater proportion of patients     undergoing first trimester intervention will have appropriate maternal gestational weight     gain as defined by the Institute of Medicine, and a greater proportion will return to     prepregnancy weight within 12 months.   "
104005|NCT01924767|"     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with     repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics     of BI 10773 after multiple dosing, including dose proportionality and assessment of steady     state.   "
103877|NCT01926444|"     GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative     to i.v. sedation during full colonoscopy. It will be evaluated for efficacy and safety in a     multi-center, randomized, double-blind, placebo controlled, dose-ranging, proof of concept     Phase 2a trial. Up to 240 patients will receive one of 3 doses of GIC-1001 or its matching     placebo. A pharmacokinetic evaluation will be carried out on a subset of patients (N: 24).   "
103878|NCT01926431|"     The primary aim of this study was to determine the effects of an acute bout of high intensity     exercise on the brains response to viewing pictures of food using functional magnetic     resonance imaging (fMRI).   "
103879|NCT01926418|"     The purpose of this study is to assess the utility of the Theory of Planned Behavior in     predicting condom use among men who have sex with men. It also aims to assess the utility of     two interventions, one known as implementation intentions, the other involves the practice     of a planning task known as the tower of Hanoi, in increasing condom use in this     population.   "
103880|NCT01926405|"     Hypersomnia is defined as a reduced ability to remain awake during the day. There are     basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently,     the diagnosis of these sleep disorders is based on polysomnographic recordings which is     difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.      A biological marker of sleepiness, easily accessible and measurable, would be very useful for     the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions     appear as good physiological markers. Studies have shown for healthy subjects, that the     expression and activity of salivary amylase are increased when subjects are deprived of     sleep.      The investigators propose to explore the usefulness of salivary biomarkers (including     amylase) as a new non-invasive and simple technique for the assessment of excessive daytime     sleepiness.   "
103881|NCT01926392|"     Partial thickness burns are a common, painful injury requiring a great deal of resources in     their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to     remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to     silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain     control and resources required to deliver care.   "
103882|NCT01926379|"     The purpose of the ENRICH study is to evaluate a combination intervention package (CIP)     designed to improve implementation of Isoniazid Preventive Therapy (IPT) among people living     with HIV (PLWH) in Ethiopia. The study is a two-arm cluster randomized trial, randomized at     the HIV clinic level, which includes 10 HIV clinics in Dire Dawa and Harari, Ethiopia.     Clinics are randomized to deliver the combination intervention package (CIP) or standard of     care (SOC), with stratification by facility size (<80 or >80 patients enrolled in HIV care     per year). The experimental intervention will be delivered to all patients in HIV clinics     randomly assigned to CIP who initiated HIV care at the CIP site on or after January 1, 2013     and initiated IPT on or after date of study initiation, July 1, 2013. In HIV clinics assigned     to SOC, usual care procedures for provision of IPT will be delivered.      Study Aims and Hypotheses      Aim 1. Characterize and compare the effectiveness of a combination intervention package with     standard of care for IPT provision in Ethiopia.      Hypothesis 1.1: IPT initiation for new patients enrolling in HIV care at CIP clinics will be     higher than that for newly enrolled patients at SOC clinics.      Hypothesis 1.2: Adherence to and completion of IPT for participants initiating IPT at CIP     clinics will be higher than that for those initiating IPT at SOC clinics.      Aim 1a. Assess acceptability of CIP among participants enrolled in HIV care and healthcare     providers at CIP clinics. Acceptability will include: 1) perceived barriers and facilitators     of uptake and delivery of the intervention package among healthcare providers, and 2)     acceptability and utilization of intervention components as well as the overall intervention     package among IPT initiators and non-initiators.      Aim 2. Assess the impact of CIP compared with SOC on HIV-related outcomes.      Hypothesis 2: HIV-related outcomes for participants receiving IPT at CIP clinics will be     superior to outcomes in participants receiving care at SOC clinics. HIV-related outcomes to     be assessed include retention in care and, among those participants receiving antiretroviral     therapy (ART), adherence to ART and CD4+ count.      Aim 3. Assess the safety and tolerability of IPT among HIV-infected individuals under routine     program conditions in Ethiopia.      Aim 4. Identify patient and program characteristics associated with IPT adherence and     completion at SOC sites.      Hypothesis 4.1: IPT adherence and completion will be associated with modifiable patient     characteristics, including ART status; knowledge and attitudes about IPT; and social support.      Hypothesis 4.2: IPT adherence and completion will be associated with modifiable program     characteristics, including provider/patient ratio, patient tracking, and patient support     groups.   "
103883|NCT01926366|"     This is a randomized, double-blind, placebo-controlled study of single and multiple ascending     dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening     period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4-     to 10-day follow-up period after discharge.   "
103884|NCT01926353|"     Endoscopic correction of VUR has gained its popularity due to its less invasiveness,     associated low morbidity and short hospital stay. Although short term follow-up had justified     their efficacy; however, long term recurrence and complications following endoscopic     correction were also being reported in the literatures (6). Currently, there are insufficient     evidences on the efficacy and safety of biocompatible tissue augmenting materials used for     endoscopic correction of VUR; particularly on the new tissue bulking agents. (6) Polyacrylate     polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba, Argentina) is the newest tissue     augmenting biocompatible Acrylics used for endoscopic correction of VUR.   "
103885|NCT01926340|"     The study aims to examine the relationship between early maintenance therapy decisions in     first episode psychosis, and the subsequent long-term clinical outcome at 9-10 years by     comparing a group of patients who were randomized to discontinue (placebo) or continue     medication (quetiapine) in the early stage of their psychotic disorders.   "
103922|NCT01925859|"     To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone     sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy     volunteers, based on plasma concentrations of dexamethasone.   "
103900|NCT01926145|"     The objective of this study is to describe: 1) Differences in perceived health at hospital     discharge between diagnostic groups and in-hospital predicting factors. 2) Perceived health     at hospital discharge as a predictor of morbidity and mortality after 1 and 3 years. 3) The     association between perceived health, sick leave and health care utilization.      The five heart centres in Denmark diagnose and treat about 50.000 patients with different     diagnoses every year and offer both invasive and non-invasive treatment.      Perceived health status is measured by self-reported health, quality of life, anxiety and     depression and symptoms. Knowledge about perceived health status can help to guide inpatient     practise and outpatient follow-up. Furthermore, it can be used to evaluate differences     between diagnostic groups, regional differences and predicting factors for perceived health     status at hospital discharge and long term morbidity and mortality. Also economic analysis of     healthcare utilisation and work ability status are possible.      Five Danish heart centres (Rigshospitalet, Gentofte Hospital, Odense University Hospital,     Aarhus University Hospital and Aalborg University Hospital) are all including patients from     April 2013 to April 2014. All patients discharged or transferred from one of the heart     centres are potential participants in the study. Patients are unselected and consecutively     included at hospital discharge. Included patients will be asked to complete and return a     questionnaire before they leave the hospital.      The following questionnaires will be used to measure the perceived health status of the     patients at hospital discharge: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief     Illness Perception Questionnaire, HeartQoL and Edmonton Symptom Assessment Scale. Furthermore     14 ancillary about health and health behaviour are included in the questionnaire. This     amounts to a total of 62 items in the questionnaire.      The DenHeart study data collection, database development and reporting of primary outcomes     are funded by the five participating heart centres in Denmark. Further funding for registry     data, analyses and reporting will be applied for in external funds.   "
105793|NCT01901302|"     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment     of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer     pain.   "
103886|NCT01926327|"     Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the     knee has significantly elevated in the elderly population and youth due to age and sport     activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee     pain and improve its function; return patients to normal daily activities and reduce health     care costs.      The current treatments which are already being used for osteoarthritis of the knee patients     include:        1. Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal          anti-inflammatory drugs.        2. Intra-articular injections of corticosteroids and hyaluronic acid.        3. Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.      As the low mitotic activity and lack of blood supply cause little ability for the articular     cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received     much more attention due to its capacity to do self-healing in treatment of osteoarthritis of     the knee.      PRP consists of several concentrated growth factors in platelets of autologous blood that are     applied to the different parts of medicine such as reconstruction of damaged tissue. Although     platelets are well-known to involve in the blood clots formation, but current studies have     shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells     and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.      This study is a prospective, randomized, controlled trial to assess The positive effects of     platelet-rich plasma injection in 244 patients with osteoarthritis of the knee   "
103887|NCT01926314|"     Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and     development of pelvic floor dysfunction. This may leed to devastating loss of function and     quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor     muscle training with the device PHENIX Neuromuscular Stimulation Therapy Systems on the     recovery of pelvic floor function for primiparous women.   "
103888|NCT01926301|"     The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic     shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular     autoregulation.      Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in     patients with acute severe sepsis and septic shock.   "
103889|NCT01926288|"     The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets     in Chinese patients with hepatitis B   "
103890|NCT01926275|"     The aim of this study is to determine whether noninvasive positive pressure ventilation with     inspiratory muscle training can improve quality of life and respiratory muscle strength than     noninvasive positive pressure ventilation or inspiratory muscle training alone.   "
103891|NCT01926262|"     The aim of this project is to investigate, whether physical training, targeted neck and     shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and     crewmembers.   "
103892|NCT01926249|"     A Multicenter national prospective cohort study including at least 2300 individuals     consecutively recruited from French Research Memory Centers and followed-up over 5 years.   "
103893|NCT01926236|"     The purpose of this study is to determine whether fit patients (with ECOG performance score     of 0-1) with advanced biliary tract cancer (ABC) benefit from chemotherapy in the second-line     setting (after prior therapy with cisplatin and gemcitabine) in terms of overall survival.   "
103894|NCT01926223|"     Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide     home visiting program for first time parents aged 20 years and under. The evaluation uses a     mixed-method design to assess participant outcomes in five program goal areas: 1) prevention     child abuse and neglect; 2) optimal child development; 3) educational achievement and     economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged     births.   "
103895|NCT01926210|"     This is a prospective, randomized clinical trial to compare the efficiency and safety of mild     stimulation and controlled ovarian stimulation protocol on the treatment of POR. The     randomization is achieved on the basis of a computer-generated randomization list in a 1:1     ratio.   "
103896|NCT01926197|"     The goal of this study is to determine the safety and efficacy of a chemotherapy regimen     known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body     Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the     disease and improve survival for patients with locally advanced pancreatic cancer.   "
103897|NCT01926184|"     In the era of HIV treatment as prevention (TasP), efforts are needed to identify     evidence-based combination prevention approaches that achieve greater decreases HIV viral     load among populations that are more likely to engage in HIV transmission risk behavior.     Because methamphetamine-using men who have sex with men (MSM) are at greater risk for     acquiring and transmitting medication-resistant strains of HIV, interventions targeting     stimulant use in this population of high-risk men could boost the effectiveness of TasP. At     present, only conditional cash transfer approaches such as contingency management (CM) have     demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who are     not actively seeking formal treatment. The proposed RCT will examine the efficacy of a     positive affect intervention that is designed to optimize the effectiveness of CM to achieve     long-term reductions in stimulant use and HIV viral load in this population. the     investigators' team will examine the efficacy of this integrative intervention in a     randomized controlled trial (RCT) with 230 HIV-positive, methamphetamine-using MSM. After     enrolling in CM, participants will be randomized to receive either: 1) the positive affect     intervention; or 2) a attention-matched control condition. Follow-up data will be collected     at 3, 6, and 12 months post-randomization. This RCT will provide an opportunity to examine     the efficacy of an integrative intervention designed to promote long-term reductions in HIV     viral load as the primary outcome. Secondary outcomes that will be examined include:     increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+)     count, and decreases HIV transmission risk behavior. Identifying an efficacious intervention     approach to decrease HIV viral load among methamphetamine-using MSM would substantially     support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate     HIV-related health disparities.   "
103898|NCT01926171|"     The purpose of this study is to evaluate the safety and efficacy of icotinib in combination     with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint     is objective response rate of intracranial lesions.   "
103899|NCT01926158|"     This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis     drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant     osseointegration (bone bonding) in postmenopausal women after total hip replacement. The     patients with low bone mineral density (BMD) and those with normal BMD will be analyzed in     separate groups. The investigators assume that denosumab prevents periprosthetic bone loss     and enhances bone bonding of the hip stem in women with osteoporosis.   "
104181|NCT01922466|"     The purpose of this study is to evaluate the efficacy and safety of east-west collaborative     treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and     quality of life of patients with chronic cervicalgia   "
103901|NCT01926132|"     Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids,     proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA.     Ascorbic acid was known to protect mitochondrial injury against oxidative stress by     depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was     suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function.     There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The     investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample     may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The     investigators will compare the mtDNA copy number and fatigue scale between moderate-severe     fatigue patients and control group that had not malignant and chronic illness by a randomized     controlled trial.   "
103902|NCT01926119|"     The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS)     may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will     test various methods of TMS in a small pilot study to investigate what methods may have     clinical potential. This is a small pilot study to determine feasibility and signal to     potentially inform future trials.   "
103903|NCT01926106|"     In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth     would decrease the incidence of intubation or death in twin infants when compared to nCPAP.   "
103904|NCT01926093|"     We aimed to assess the accuracy of visual and quantitative analysis performed on low     radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation     dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment     will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of     the disease in ARDS patients.   "
103905|NCT01926080|"     Experts agree that neonatal death has long-term impact on parents. Many parents experience     sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. There     are no prospective studies that evaluate the effectiveness of bereavement management and     follow-up on the grief process following the death of a newborn. The purpose of this study is     to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program     and the use of a newly designed family-centered bereavement DVD. This educational DVD     includes personal interviews with parents, grandparents and siblings who have experienced the     lost of a baby in the NICU.   "
103906|NCT01926067|"     Aim of the study: To validate accelerometers for continuous monitoring of global cardiac     function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.   "
103907|NCT01926054|"     This is an open-label, randomized, multi-center, Phase IV study of Acthar Gel in patients     with biopsy-proven membranous (Class V) lupus nephritis (LN) aimed at providing     proof-of-concept data that Acthar is a safe and effective therapy for membranous LN. Class V     LN is a secondary form of membranous nephropathy, and occurs in 8-20% of patients with LN.      Two different doses of Acthar Gel will be tested. The active intervention phase of this study     will take place over 6 months, and follow-up will occur over the following 6 months. Efficacy     and safety of the use of Acthar Gel for treatment of membranous LN will be assessed and     analyzed throughout the course of the study by laboratory testing, physical exams, and other     evaluation tools. Subjects will be closely monitored for adverse effects associated with the     use of Acthar gel and if necessary study drug dosing will be reduced. The anticipated     benefits to subjects are a complete renal response rate of 40% at 6 months showing     superiority over the published complete remission rates of the currently used     immunosuppressive therapies, and no unexpected toxicity signals.      Pure Class V LN affects a significant number of systemic lupus erythematosus (SLE) patients     and although it is less aggressive than proliferative forms of LN it still causes important     renal and non-renal morbidity and mortality over time, especially in patients who remain     nephrotic. The therapy of Class V LN is not clear, and currently used therapies are highly     toxic because of immunosuppression, risk of infertility, and risk of future malignancy.     Additionally, these therapies are only modestly effective in inducing remissions of Class V     LN. There is thus an unmet need for a more effective and less toxic treatment for Class V LN.   "
103947|NCT01925534|"     The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen     delivery system, is superior to standard oxygen therapy during breaks off noninvasive     ventilation in patients affected by acute respiratory failure and in respiratory distress.     The investigators anticipate that the Optiflow will provide oxygen more effectively, be more     comfortable and permit longer breaks off NIV, shortening the total duration of NIV.   "
103948|NCT01925521|"     The objective of this trial is to evaluate the safety and tolerability of single and multiple     ascending oral doses of OPS-2071 in healthy male Korean   "
103949|NCT01925508|"     The purpose of this study is to verify that the implementation of a protocol physiotherapy     musculoskeletal pain and reduces anxiety and improves quality of life in patients     hospitalized at the clinic of high-risk pregnancies at the Hospital das Clinicas of Ribeirao     Preto, with a diagnosis of preeclampsia and chronic hypertension with superimposed     preeclampsia. Where patients will be recruited, answered questionnaires before and after     application of physiotherapy protocol.   "
103908|NCT01926041|"     Diabetes mellitus (DM) has been established to contribute to cardiovascular comorbidities,     malignancies and higher mortalities. The management of DM is not limited to aggressively     controlling sugar levels after the diagnosis; instead, should be emphasized more on effective     modification for prediabetics. Smoking cessation were also demonstrated to improve insulin     resistance. Nowadays, the 2nd-generation cessation program in Taiwan brings higher     accessibility. However, there is little evidence on the long-term health outcomes of     combining smoking cessation and coach-assisted lifestyle change for the prediabetics in the     community.      The present new project extends the original pilot project (NSC 102-2628-B-002-046-MY2 and     MOST 104-2314-B-002 -072) from August of 2013. The investigators have been making efforts to     promote this project by cooperating with primary care doctors of the community medical groups     and corporate nurses. Over 446 prediabetic smokers will be enrolled by July of 2017. The     invention includes smoking cessation clinics for up to 16 weeks (from January to December of     2017) and coach-assisted lifestyle change (from January of 2017 to July of 2020 and later)     for every participant joining intervention. The lifestyle coaches will help the participants     in intervention group reach the goal of at least a 7 percent weight loss within the first 6     months. All smokers with prediabetes in intervention and self-management group are provided     with educational materials for lifestyle change. All prediabetic smokers are prospectively     followed up every 6 months till July of 2020 and later for smoking status, anthropometric     indices and blood tests.      Regarding the potential contribution to the national socio-economic development, this project     will strengthen the motivation of smoking cessation in prediabetic smokers. Academically, cox     regression will be used to investigate the effectiveness of the smoking cessation combined     with coach-assisted lifestyle change on DM prevention in smokers with prediabetes. This     prospective project will contribute to community-based diabetes research in preventive     medicine.   "
103909|NCT01926028|"     This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess     the safety, tolerability and humoral and cellular immune response over a 12-month period     after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In     addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of     vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated     relative to placebo.   "
103910|NCT01926015|"     The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and     Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260)     in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates     to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with     staggered administration of RotaTeq™.   "
103911|NCT01926002|"     The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early     asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of     forced expiratory volume (FEV1) when compared to placebo.   "
103912|NCT01925989|"     This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each     period, participants will receive once daily injections of stable dose LY2605541 or insulin     glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats     and sugars. Participants will continue to use meal time insulin throughout the study. Healthy     participants will also enroll in the study. They will not receive any study medication.   "
103913|NCT01925976|"     The purpose of this study is to implement an individualized, face-to-face, parent supported     and school-partnership dietetic intervention program to promote healthy eating habits in     obese, Hispanic, children from low socioeconomic status due to the high predisposition to     unhealthy eating habits and obesity in this population.   "
103914|NCT01925963|"     The purpose of the research study is to collect information about brain function and     structure among active duty military personnel or civilians who are healthy. Researchers want     to develop a database from normal volunteers that will be used in comparison with a similar     database from active duty military with post-concussive syndrome (PCS) from a mild traumatic     brain injury. Findings from this study may be used to design larger studies that will     evaluate whether hyperbaric oxygen treatments actually improve PCS.      Participants in this study will undergo numerous tests to assess physical, mental, and     intellectual health and how they might change over time. Participants will wear heart and     activity monitors, undergo brain imaging, provide blood and urine for laboratory testing, and     have vision, hearing, balance, and muscle function tests. They will also complete a number of     questionnaires and interviews. This battery of tests will be repeated twice more over the     course of 6 months.   "
103915|NCT01925950|"     Use of an oral topically-active glucocorticoid with limited side effects may control the     gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.   "
103916|NCT01925937|"     The aim of this study is to compare the effect of addition of combination of     Atorvastatin/CoenzymeQ10 to standard congestive heart failure (CHF) treatment versus addition     of Atorvastatin alone on CHF outcomes.   "
103917|NCT01925924|"     Demineralization during orthodontic (brace) treatment is a common clinical problem leading to     unsightly white or brown marks on the teeth. A recent systematic review has shown little     evidence that current methods of delivering fluoride are effective at reducing this problem.      Design: A multi-centre randomised single blinded controlled clinical trial will be conducted     with two parallel groups.      Setting: The trial patients will be treated by eight named operators on the Specialist List     for Orthodontics held by the General Dental Council and who work either within the hospital     service or specialist orthodontic practice. The sample size calculation suggests that each     operator will need to treat 40 patients in the trial (approx 1 session per week) plus up to     10 familiarisation patients before.      Planned trial interventions: Brackets will be bonded to all teeth in front of the first     permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a light     cured composite control (Transbond). The material to be bonded will be allocated randomly.      Outcome measures: The two main outcome measures will be the difference in demineralization of     the anterior teeth before and after treatment assessed from photographs and the number of     debonded brackets during treatment.   "
103918|NCT01925911|"     To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A     (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with     midazolam in healthy subjects.   "
103919|NCT01925898|"     Sedation is often needed for young children undergoing minor procedures in the emergency     department (ED). Oral midazolam is one of the most commonly used regimens for children     undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only     one randomized controlled study oral ketamine has been used successfully for procedural     sedation for laceration repair. A recent study showed that the combination of oral midazolam     and oral ketamine provided deeper sedation compared with oral midazolam alone. However     children treated wuth the combination of midazolam and ketamine required longer recovery      Hypothesis:      Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation     for laceration repair.   "
103932|NCT01925729|"     This study will determine if exposure to an allergy material (ragweed) or exposure to an     allergic-symptom-provoking substance (histamine) and medications typically used to decongest     the nose changes the rate of blood-flow in the lining of the middle-ear. Otitis media (the     build-up of water-like fluid in the middle-ear airspace) may occur if the blood flow in the     lining of the middle-ear is too high and may be prevented if a way could be found to lower     the blood flow in persons susceptible to the disease. Middle-ear blood flow is measured     indirectly by measuring the change in middle-ear pressure while a person breathes a gas     mixture containing nitrous oxide (laughing gas). In this study, 4 groups of subjects will     be entered and middle-ear pressure in persons breathing a mixture of 50% Oxygen, 50% Nitrous     Oxide (laughing gas)will be measured after exposure to one of four substances (ragweed,     histamine,an oral decongestant, a decongestant nasal spray) and a fake medication (placebo)     at separate test sessions. All subjects will have one set of 2 x-rays of the middle ears and     mastoids. The group exposed to ragweed will require 3 study visits while the other 3 groups     will have 2 study visits. From this information middle-ear blood flow will be calculated.     This will help determine the relationship between what happens in the nose and what happens     in the middle ear.   "
103923|NCT01925846|"     Microbial infection of the cornea, also known as microbial keratitis, causes severe corneal     inflammation that could result in permanent visual loss. Contact lens wear is the strongest     risk factor related to microbial keratitis in developed countries. The most commonly isolated     pathogen of contact lens associated microbial keratitis (CLMK) is Pseudomonas aeruginosa,     which accounts for over one third of the cases. Among the various virulence factors involved     in the pathogenesis of pseudomonal keratitis, a secretion system known as type three     secretion system (T3SS) secretes toxins that damage the host cells. ExoS is a bifunctional     exotoxin with GTPase-activating protein (GAP) activity and ADP ribosyl transferase (ADPRT)     activity. It results in an invasive phenotype of P. aeruginosa causing a relatively slower     host cell death with intracellular invasion and possibly proliferation of bacterium. In     contrast, ExoU expressing strains carries a cytotoxic phenotype that causes rapid host cell     lysis due to its phospholipase activity. Previously, cytotoxic strains were reported to be     more commonly found in patients with pseudomonal keratitis and were highly correlated with     multidrug resistance.      In order to understand the pathogenesis of CLMK, especially pseudomonal related CLMK, we     proposed to recruit 180 volunteers who will wear different contact lens materials. We then     collect the used contact lens and analyze 1) the microbiota on the used contact lens; 2) the     bacterial-contact lens adhesion of wild strains, pscC mutant strains (T3SS needle-comples     mutant), cytotoxic strain, and invasive strain P. aeruginosa; 3) the effect of shearing     forces on bacterial-contact lens adhesion; 4) the bacteriocidal effect of multipurpose     solution on different strains of P. aeruginosa.   "
103924|NCT01925833|"     Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with     careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g.     <1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon     is in different conformation during insertion and withdrawal phases. We think careful     inspection and polypectomy during both insertion and withdrawal can improve adenoma detection     rate.   "
103925|NCT01925820|"     Currently, there are several antiviral treatments effective for suppression of viral     replication but still failed to cure HBV infection in patients with chronic hepatitis B     (CHB). Seven drugs have been worldwide approved for the treatment of CHB at present:     conventional IFN (IFN) alfa, lamivudine (LAM), adefovir dipivoxil (ADV), pegylated IFN     (Peg-IFN) alfa, entecavir (ETV), telbivudine (LdT) and tenofovir (TDF). Conventional or     Peg-IFN alfa monotherapy has a narrow range of efficacy, is associated with several adverse     effects and is inconvenient because of frequent injections. Oral nucleot(s)ide analogues (NA)     are better tolerated; but virologic response to NA is frequently not durable and prolonged     treatment is associated with the emergence of drug-resistant HBV mutants.      Although the best treatment choice for CHB is not clarified yet, certain therapeutic concepts     could be derived from the experience of treating patients with chronic hepatitis C or human     immunodeficiency virus (HIV) infection. A major advancement in treating hepatitis C or HIV     infection has been the development of combination therapy. Combination therapy has ever been     investigated in patients with CHB, but again the optimal strategy remains to be identified.     Entecavir, a carbocyclic deoxyguanosine NA, is one of the most potent anti-HBV agents ever     discovered. In addition, the 6-year drug resistance rate is 1.2% in selected lamivudine-naïve     cohorts. Pegylated interferon alfa-2a possesses both antiviral and immunomodulatory effects.     Overall, satisfactory virologic and serologic responses could be achieved using pegylated IFN     alfa in around 30-44% of these patients. Whether the combination therapy using Peg-IFN     alfa-2a plus ETV can achieve a long-term beneficial effect against ETV or Peg-IFN alfa-2a     alone is not clarified. A prior single-arm pilot study suggested that similar combination     therapy may be beneficial in patients with CHB. In this proposal, the investigators thus     hypothesize that the efficacy by using combination therapy with Peg-IFN alfa-2a plus     prolonged ETV is superior to that by using ETV or Peg-IFN alfa-2a alone in that Peg-IFN may     restore host immunity against HBV and prolonged ETV can maximize viral suppression.      The objective of this clinical trial is to evaluate the efficacy of the combination of     Peg-IFN alfa-2a at a dose of 180 mcg administered subcutaneously per week and ETV 0.5 mg     daily for 48 weeks followed by ETV 0.5 mg daily monotherapy for an additional 96 weeks versus     ETV 0.5 mg daily monotherapy for 144 weeks or Peg-IFN alfa-2a 180 mcg per week for 48 weeks     in patients with HBeAg-negative CHB. It will be an open-label, randomized, comparative,     multi-center clinical trial. The recruited patients will be equally randomized into three     treatment groups. Treatment-free follow-up period will be 48 weeks in both groups of     patients. The primary parameter is the Simultaneous achievement of HBsAg titer below 100     IU/ml and HBV DNA below 300 IU/ml at 144 weeks after start of treatment, by an     intention-to-treat analysis. Genotypic and virologic resistance to ETV will also be assessed     at baseline and at end of years 1, 2 and 3.      The investigators anticipate that the rate of HBsAg <100 IU/mL plus HBV DNA <300 IU/mL at 3     years of the study period will be 30% for patients receiving Peg-IFN therapy and increased to     be 45% for patients receiving Peg-IFN plus entecavir therapy. With a 5% nominal significance     level (two-sided), 163 patients per group under a 1:1:1 ratio will provide 80% power to     detect a difference of 15% in treatment response rates between group I and III. Because this     will be a 4-year study for each patient, the investigators thus anticipate that the dropout     rate may be as high as 10%. Accordingly, a total of 540 (180x3) patients will be recruited,     in order to account for a dropout rate of up to10%.   "
103926|NCT01925807|"     Suicide is the second leading cause of mortality for Canadian adolescents. Mental health     complaints are one of the leading reasons for an emergency department visit at the Children's     Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The goal of the     present investigation is to test the efficacy of a brief group intervention for adolescents     with passive suicidal ideation and their caregivers that will focus on coping, familial     support, and emotional regulation. The investigators hypothesize that a brief group     intervention, delivered in the weeks following presentation for crisis services, will reduce     suicidal ideation and improve coping and familial support.   "
103927|NCT01925794|"     This is a prospective, multi-center, non-randomized, single arm clinical trial that will be     conducted at up to 40 sites in the United States and Outside United States (OUS). This study     will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion     contained within a native coronary artery with reference vessel diameter between 2.5 mm and     4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI)     and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year     and annually for 5 years post index stenting procedure.   "
103928|NCT01925781|"     This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for     smoking cessation. Participants will be randomly assigned to either e-cigarette use or     nicotine gum use during a quit attempt. All participants will have a one hour meeting with a     tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be     determined at 12 weeks after the quit date. Continued use of nicotine replacement (either     e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be     evaluated.   "
103929|NCT01925768|"     The purpose of this study is to determine whether apremilast is safe and effective for     treating patients with psoriatic arthritis.   "
103930|NCT01925755|"     This is local prospective multicenter observational non-interventional local study. Primary     study objective is investigate and describe prescription pattern of neurologists in secondary     stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with     AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with     rivaroxaban at an initial visit and three follow-up visits.   "
103931|NCT01925742|"     Each year, 450,000 Canadian women become pregnant and, as a result of their participation in     prenatal screening for Down syndrome, approximately 10,000 of them will have an amniocentesis     (i.e. sampling of liquid surrounding the fetus) and of those, 315 will be found to carry a     baby with Down syndrome and 70 normal pregnancies will be lost from complications of the     procedure. It has been discovered recently that, during pregnancy, there is fetal DNA in     maternal blood in sufficient quantities to be analysed and methods have been proposed to     detect the presence or not of a fetus with Down syndrome using maternal blood. The     introduction of genomic blood testing as proposed in the context of this project could lead     to increased detection of Down syndrome, less invasive screening with 9700 amniocentesis     avoided each year in Canada, improving the peace of mind of pregnant women, and preventing     the accidental loss of 70 normal fetuses, at a lower overall cost than current practice.     However, these methods still need to be validated before being appropriately introduced in     routine care.      The study hypothesis is that new genomics-based non-invasive methods using fetal-DNA in     maternal blood during pregnancy can be more effective than current prenatal screening methods     for fetal aneuploidy.      This project will carry out an independent study that will validate the performance and     utility of different new genomic technologies for screening in pregnant women using maternal     blood. The team of researchers will compare the real-life performance of different     non-invasive assays and strategies to screen for fetal aneuploidy, and identify an     evidence-based cost-effective approach for implementation of this new technology in the     Canadian health care system. The deliverables of this project will enable decision makers,     pregnant women and their partner to make informed choices pertaining to prenatal genetic     screening and diagnosis, such as screening for Down syndrome, and reduce the risk to     pregnancies associated with amniocentesis.   "
103959|NCT01925378|"     Preliminary data showed that Nelfinavir has selective apoptotic effects on HPV+ cervical     tumor cell lines. Furthermore, in a Phase I clinical trial, the combination of NFV and     chemoradiotherapy showed acceptable toxicity and promising activity in patients with     pancreatic cancer. Therefore, for the proposed research, the principal investigator will use     a single-arm Phase II intervention trial study design with focus on the efficacy of NFV to     induce complete or partial remission of CIN 2/3 or CIN 3 as well as biomarker evaluation.   "
104182|NCT01922453|"     This international study is looking to see if the addition of music and sound on the maternal     abdomen encourages fetal position change from breech to vertex in near term women.   "
104183|NCT01922440|"     This is a prospective, observational, natural history registry, designed to collect data on     patients with chronic hypoparathyroidism. No study-defined procedures will be required, and     if available, a select set of data will be collected at baseline and at least annually.   "
103935|NCT01925690|"     As many as 50% of MS patients prematurely discontinue their disease modifying medications.     For this study, we will develop a telephone-based talk therapy intervention and then conduct     a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute     telephone sessions of psychotherapy or a brief education control condition. We hypothesize     that patients undergoing phone therapy will be more likely to indicate they are interested in     resuming taking disease modifying medications than patients given brief education and     treatment as usual.   "
103936|NCT01925677|"     Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci     instrumentation and Single-Site platforms.   "
103937|NCT01925664|"     The goal of this study was to evaluate the impact of a doula home visiting intervention on     young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and     parenting, and on their children's development.   "
103938|NCT01925651|"     The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy     after mastectomy, in relation to the time of treatment interruption and acute effects. This     study evaluates whether there is an increase in treatment time with the addition of the     bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous     tissue.   "
103939|NCT01925638|"     The purpose of this study is to see if there is a difference between the way your body     absorbs and distributes BAY86-9766 when given alone or in combination with ketoconazole, a     drug which may affect how much BAY86-9766 is absorbed, distributed or eliminated from the     body   "
103940|NCT01925625|"     HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late     stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.   "
103941|NCT01925612|"     This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and     efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide,     doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL that     have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP     together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is     a difference in side effects between the 2 groups.      The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab     vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)     (known as BV+RCHP) in patients with CD30-positive DLBCL that have never been treated.     Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.      The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared     to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients     will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be     tested to see if there is a difference in side effects between the 2 groups.   "
103942|NCT01925599|"     The BAP1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal     melanoma for a germline BAP1 mutation and other genetic markers associated with developing     malignancy as well as additional sequencing of the uveal melanoma genome.   "
103943|NCT01925586|"     This study is designed to look at whether it is feasible to observe women with atypical     ductal hyperplasia (ADH) of the breast, or whether surgical excision is necessary.   "
103944|NCT01925573|"     This protocol is designed to generate and provide preliminary data to determine the safety     and activity of combination therapy using tumor treating fields (TTFields;     Optune(NovoTTF-100A); Novocure, Haifa, Israel), a novel FDA-approved therapy utilizing     alternating electric fields to inhibit tumor cell growth, along with bevacizumab (Avastin;     Genentech, San Francisco, CA), a humanized monoclonal antibody that inhibits vascular     endothelial growth factor (VEGF), and hypofractionated stereotactic radiotherapy, a     highly-focal abbreviated course of brain irradiation, in the treatment of patients with     bevacizumab-naive recurrent GBM. Each of these individual therapies, and also several     combinations in doublets, has already demonstrated safety and efficacy but prospective     clinical data for the concurrent combination of all three therapies are lacking.   "
103945|NCT01925560|"     The objective of this study is to assess the tolerance and utilization of agave inulin. This     will be accomplished through analyses of breath and fecal samples to quantify fermentation     end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and     short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial     populations will also be measured in fecal samples.   "
103946|NCT01925547|"     The purpose of this study is to investigate the effect of micellar curcumin on inflammation     and lipid metabolism markers in subjects at risk for the metabolic syndrome.   "
103950|NCT01925495|"     This is a study to determine if there are reflexes that detect changes in eardrum position or     in the pressure of middle-ear gases and respond with changes in the ease by which the     Eustachian tube is opened. The Eustachian tube is the normal tube that connects the middle     ear to the nose. It is usually closed, but can be opened by contraction of 2 small muscles     that surround the tube. If the Eustachian tube does not open frequently enough, the pressure     in the middle ear will decrease, the eardrum will be pulled in toward the middle ear causing     a hearing loss, and fluid will accumulate in the middle ear to try and stabilize its     pressure. There is some evidence that the changes in eardrum position and middle-ear pressure     when the Eustachian tube does not open frequently enough can be detected by the brain that,     in turn, sends signals to the Eustachian tube and its muscles to make Eustachian tube opening     easier. In this study, we will test this possibility.      Specifically, in 3 experiments done on 5 different days, we will move the eardrum in and out,     apply different pressures to the middle ear, or change the composition of the gases in the     middle ear while we measure how difficult it is to open the Eustachian tube by increasing     middle-ear pressure or by measuring the readiness of the Eustachian tube muscles to     contract and open the tube.   "
104006|NCT01924754|"     In collaboration with the Thai Red Cross AIDS Research Centre, the investigators are     performing a study of 2 new HPV vaccine delivery regimens in healthy young Thai women. The     study will be performed in Bangkok. The investigators will be testing the serum from these     women at UCSF for HPV antibodies to measure the strength of their response to the vaccine.   "
105794|NCT01901289|"     The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to     provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting     Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.   "
103951|NCT01925482|"     This study will measure the speed at which gases move between the middle-ear air-space and     the blood flowing through the middle-ear lining. The middle ear is a rigid biological gas     pocket located behind the eardrum and is filled with the same gases as in air, primarily     oxygen (O), nitrogen (N) and carbon dioxide (CO2), but in different proportions. The middle     ear is lined by a thin layer of cells overlying tissues that surround blood vessels. The     blood that flows through the middle-ear lining also contains these same gases but at     different proportions from both the atmosphere (room air) and middle ear. Because of the     differences in the proportions of these gases, each gas tends to flow between the middle ear     and blood trying to make the proportions of gases in those compartments the same. This flow     of gases to and from the middle ear changes the middle-ear pressure. If the middle-ear     pressure decreases much below the air pressure of the atmosphere, the ability to hear sounds     is impaired and fluid can build up in the middle ear. It is expected that each different gas     will move between the middle ear and blood at a different speed, but it is not known what     those speeds are for any of the gases. It is also expected that those speeds will be     different for ears that have had middle-ear disease and those that have not. In this study,     we will measure the speed of nitrogen, oxygen and carbon dioxide exchanges in both directions     between the middle ear and blood. To do this, the gas mixture in the middle ear will be     changed so that there is movement of only one gas for each experiment and then measure the     change in the amount of the gas in the middle ear. This can be done using a special     instrument called a mass spectrometer if there is an open, working tympanostomy (ventilation)     tube, a small plastic tube, in the eardrum. For all participants in this study, we will     conduct 6 experiments lasting about 2 hours each to measure the speed of nitrogen, oxygen and     carbon dioxide flow. Subjects with and without tympanostomy tubes will be recruited. Those     without a tube will have a tube inserted in one ear for study purposes and it will be removed     at the end of the study; these subjects will be followed weekly until the hole in the eardrum     (where the tube was) is closed.   "
103952|NCT01925469|"     The objective of this study is to assess the utility of benzocaine spray versus a placebo     spray in alleviating pain during and after hysterosalpingogram (HSG).   "
103953|NCT01925456|"     A. Objectives & Hypothesis Overactive bladder (OAB) affects over 10 million adults in the     United States and each year substantial costs are incurred from private and public funds to     test the efficacy of new and existing drugs for OAB.14 However, effectiveness and adherence     data from traditional clinical trials are not generalizable to clinical practice.3, 4 In an     era of limited resources and competing demands, it is essential that cost-effectiveness data     from clinical trials be generalizable to the clinical world. Pragmatic clinical trials     measure the effectiveness of treatments in real clinical practice, and in the full spectrum     of patients that require treatment.5 Pragmatic trials require patient reported outcomes that     are valid but have low patient burden.5 The conduct of pragmatic clinical trials for OAB has     been limited by a lack of instruments that have demonstrable validity and reliability in the     typical clinical setting Pill counts, used to measure primary outcomes in most traditional     trials, are burdensome in the clinical setting.1610 The optimal instrument for measuring     utility scores, general quality of life scores for cost-effectiveness analyses for OAB, is     also not known.      Although poor adherence carries the potential for continued suffering for patients and wasted     health care resources, there is a lack of data on the clinical and economic impact of poor     adherence to treatment for OAB in real-world clinical practice. We have published preliminary     data that underscores the role of adherence and utilities in the treatment of OAB. 3 Our     hypothesis is that effectiveness, adherence, and utility preference scores can be measured     using pragmatic patient reported instruments and that poor adherence is associated with lower     effectiveness and quality of life in adults with OAB in a clinical setting. Specifically, the     overriding goal of this proposal is to validate pragmatic instruments to measure     effectiveness, adherence and utility preference scores and obtain preliminary data on the     effect of adherence and quality of life in adults undergoing treatment for overactive bladder     in a clinical setting.   "
103954|NCT01925443|"     The low level laser therapy is able to improve immediately and long term (after 4 weeks of     treatment, 3 days per week resulting in 12 applications of low level laser therapy)     isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular     work , maximum power and fatigue index - normalized by body weight) pre-exercise concentric     isokinetic quadriceps femoris muscle in subjects with diabetes mellitus     non-insulin-dependent.   "
103955|NCT01925430|"     A new device is being developed to screen for sleep-breathing disorders. Within this device     is a new software algorithm which will determine sleep/wake states. The aim of this study is     to evaluate the performance of this new algorithm. This prototype will be compared against a     commercially available device which monitors sleep/wake patterns. Volunteers will be asked to     wear the prototype and comparative devices for 1-2 nights. The data from both devices will be     downloaded after the completion of the study and analysis wil be performed to compare the two     recordings.   "
103956|NCT01925417|"     This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as     a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the     primary symptom of recurrent Clostridium difficile infection. All eligible subjects will     receive RBX2660.   "
103957|NCT01925404|"     Encouraging greater levels of physical activity is critical to improving health among     Americans, who are largely sedentary. Neighborhood parks are resources for physical activity     that are available to most Americans within a couple miles of their homes, yet many residents     are unaware of the programs and facilities available. Previous research indicates that park     use is related to park programming and outreach. Because funding for parks is limited,     low-cost interventions are needed to attract more people to parks to engage in     moderate-to-vigorous physical activity. While many community-based organizations would like     to invest in efforts that increase physical activity, few low-cost park programs are     documented to be both scalable and cost-effective. Effective programs that can be replicated     to make population-level impacts are needed. The goal of this study is to develop and test 2     low-cost community-level approaches, free exercise classes vs. a frequent user program, to     promoting physical activity, singly and in combination, in 48 park settings in Los Angeles     low-income neighborhoods.   "
103958|NCT01925391|"     Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye     is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic     nerve, cornea and other structures. Accurate intraocular pressure measurements in young     children is often impossible to obtain in an office setting. Children need sedation or     general anesthesia to determine IOP. All volatile general anesthetics affect the IOP. Nitrous     Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since Nitrous Oxide     has shown to be safe and effective in a variety of practice environments, we want to evaluate     the use of nitrous oxide in oxygen to obtain IOP measurements in children.   "
103960|NCT01925365|"     Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia     and heart disease, however the mechanisms by which oats or oat fractions exert this effect is     not totally clear. Furthermore, several large epidemiological studies and a number of recent     meta-analyses of nutritional interventions have reported a positive association between     increased whole grain intake and reduced risk of developing a range of chronic diseases.     Recognising the important role of the gut microbiota in metabolism and metabolic disease     risk, we examined the impact of whole grain oats on the human gut microbiota and     cardio-metabolic risk factors.      The main aims of this human study is to determine the effectiveness of a low GI whole grain     oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially     modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and     inflammation markers in an at risk of cardio-metabolic disease population   "
103961|NCT01925352|"     To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment     in ischemic heart disease.   "
117695|NCT01745380|"     The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for     inducing pulpal anesthesia of the maxillary teeth in adults.   "
103962|NCT01925339|"     The purpose of this study is to compare two different timings of restoring dental implants     that are placed right after tooth extraction: The test group will have the provisional crown     placed at the time of implant placement. The control group will have the tooth removed and     the implant placed at the same appointment but restorations placed after 4 months. Both     procedures currently are accepted methods for replacing missing teeth but direct comparisons     of the two procedures are lacking. The results of this study should aid clinicians in     selecting the best timing for restoring implants for their patients. The hypothesis is that     immediate restoration might increase aesthetic outcomes, e.g. less mucosal recession.   "
103963|NCT01925313|"     Study objectives        -  To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine          besylate after a single oral administration in healthy male volunteers.        -  To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral          administration in healthy male volunteers.   "
103964|NCT01925300|"     This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and     rosuvastatin in healthy male volunteers.   "
103965|NCT01925287|"     Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake,     rapid metabolism and excretion from the body. Considering its potent reported     health-beneficial properties, researchers have tried to increase its bioavailability as a     means to enhance its biological activities.      Objective: The aim of the project was to develop novel curcumin formulations with enhanced     oral bioavailability and to study the safety of the formulations and potential     sex-differences in humans.      Design: In this single-blind crossover study with three arms separated by ≥1-week washout     periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in     random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or     liquid micelles. Blood and urine samples were collected in intervals for 24 h and total     curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.   "
103966|NCT01925274|"     This study will investigate whether the combination of PF-05212384 plus Irinotecan improves     progression free survival in patients with KRAS and NRAS wild type metastatic colorectal     cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in     Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients     enrolled at Japanese sites.   "
103967|NCT01925261|"     This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino     acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee     cartilage in subjects with bilateral osteoarthritis of the knee.   "
103968|NCT01925248|"     The purpose of this study is to investigate whether intake of protein supplement just before     meals lowers the blood sugar levels after the meals. It is believe that pre-meal     administration of a high-protein supplement can effectively improve glycemic control in type     2 diabetes (DM).   "
103969|NCT01925235|"     Patients with impaired renal function are at elevated risk for development of acute kidney     injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and     mortality. Effective AKI prevention strategies are needed. Remote ischemic preconditioning     (RIPC) is a novel and successful strategy to attenuate contrast medium induced AKI in     patients undergoing elective coronary angiography.      The retrospective RenPro-TAVI Trial was designed to test the hypothesis whether remote     ischemic preconditioning might attenuate kidney injury in patients receiving transcatheter     aortic valve implantation (TAVI).      Patients with impaired renal function undergoing TAVI will be evaluated in respect whether     they received remote ischemic preconditioning before the procedure or not. This study will     give insight if RIPC might be beneficial in these patients.   "
103970|NCT01925222|"     The purpose of this study is to assess the direct effects of the ten-valent pneumococcal     conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.      These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive     pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov     Identifier:NCT00861380) during 2009 to 2011.      Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder     non-vaccinated siblings aged 5 to 9 years.   "
103971|NCT01925209|"     This study evaluated the efficacy, safety and tolerability of multiple doses of     bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function,     muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).   "
103994|NCT01924910|"     The purpose of this study is to determine if a single dose of vitamin D administered orally     in the fall will provide adequate vitamin D in healthy individuals for the duration of the     winter, during which vitamin D levels are known to decrease. The investigators are also     interested in finding out if this level of vitamin D will provide adequate levels for the     remainder of the year. While the benefits of once-yearly vitamin D administration are clear     for patients with osteoporosis, osteomalacia, rickets, and other conditions associated with     vitamin D deficiency and high bone turn-over, studies have not been performed in which high     doses of vitamin D were used to prevent the seasonal decline of vitamin D concentrations in     healthy individuals. These findings could provide evidence to support vitamin D     administration to healthy individuals in the wintertime to improve health outcomes, and     provide the basis for additional studies in both healthy and sick populations.   "
103972|NCT01925196|"     Background:      - Some people have a mutation in the C9ORF72 gene that causes amyotrophic lateral sclerosis     (ALS) or frontotemporal dementia (FTD). The mutation causes a small piece of DNA to repeat     itself thousands of times. The C9ORF gene mutation mostly occurs in families. In those     families, some persons have ALS and others have FTD. Occasionally the C9ORF gene mutation     occurs in persons without a family history. Researchers want to understand how this gene     causes different diseases. They will study how symptoms caused by the C9ORF gene develop and     change over time. They will measure symptoms that occur in ALS and in FTD. In particular,     they will measure strength, ability to move, thinking, and memory. They will also see if     other tests are associated with progression of disease. These tests, called biomarkers, may     help detect or measure C9ORF72 disease in the future.      Objectives:      - To understand how symptoms change over time in people with mutations in a gene called     C9ORF72, which causes ALS and FTD.      Eligibility:      - Adults over age 18 who have this genetic mutation      Design:        -  Participants will have up to 4 in-person visits and 3 telephone interviews over 3 years.          Each in-person visit may take place over several days. They may be either inpatient or          outpatient visits.        -  At each visit, participants will undergo a series of brain, language, and behavior          tests. These will include:        -  Magnetic resonance imaging (MRI) of the brain. This uses magnets, radio waves, and          computers to produce detailed pictures of the brain.        -  Collecting spinal fluid. The clinician will make the participant s back numb and then          insert a needle to collect fluid.      <TAB>- Blood samples will be taken.      <TAB>- Participants will be asked to perform several language and movement tests.      <TAB>- Small skin samples will be taken on one visit      - Between visits, participants will answer questions about their health over the phone 3     times.   "
103973|NCT01925183|"     Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon     (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients     infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed     treatment duration of 48 weeks is used.      The aim of this study is to assess efficacy and safety of response-guided triple-therapy with     BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration     will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients     will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be     treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment     duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of     BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.   "
103974|NCT01925170|"     A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive     than mammography for detecting breast cancer in women with dense breasts. The purpose of this     study is to see if MBI using a low dose of gamma radiation can find cancers not seen on     mammography.      Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal     or higher positive predictive value than SM in women age 40 and older with mammographically     dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously     achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate     (specificity >90%) that permits its use as a screening tool in this patient population.   "
103975|NCT01925157|"     The main purpose of this study is to evaluate the safety of the study drug known as LY3090106     in healthy participants and in participants with RA who are having an inadequate response to     methotrexate (MTX). The study will investigate how the body processes the study drug and how     the study drug affects the body. The study will last about 3 months for each participant.   "
103976|NCT01925144|"     The main purpose of this study is to find out how the body will react to a study drug called     baricitinib when taken with another drug called omeprazole.      For each participant, this study will include 2 periods in fixed order. The study will last     approximately 25 days, not including screening.   "
103977|NCT01925131|"     This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given     together with combination chemotherapy in treating patients with relapsed or refractory acute     leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express     cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in     chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may     kill more cancer cells.   "
103978|NCT01925118|"     Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall     response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In     addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or     renal cell carcinoma with a durable response in patients who achieved complete remission.     Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic     anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.   "
103979|NCT01925105|"     Like most developed countries the population of Sweden is getting older and consequently the     number of individuals with chronic diseases will be an increasing challenge for its     healthcare system. To improve care of the frail elderly, wards with a coordinated     multidisciplinary team and multidisciplinary mobile teams were established several years ago.     Treatment and follow up is planned in accordance to the patients' medical, psychological and     functional capabilities (Comprehensive Geriatric Assessment = CGA). There are to our     knowledge only few studies concerning CGA applicable to Swedish conditions. We plan to     conduct a Swedish study that evaluates if care and treatment with a modified CGA-model in an     outpatient setting can improve quality of life for frail older people.   "
103980|NCT01925092|"     Study objectives are to obtain safety, pharmacokinetic, and pharmacodynamic data on the     effect of mifepristone on glucose metabolism, body weight and the growth-hormone-IGF in     children with refractory Cushing's disease.   "
104003|NCT01924793|"     This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with     parainfluenza infection.      All subjects will have additional PK and Immunogenicity blood samples collected.   "
104043|NCT01924273|"     Port wine stains Birthmark are congenital, progressive vascular malformations of the skin     that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the     United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds of     these malformations occur on the face. Personality development of virtually all patients is     adversely affected as a result of the negative reaction of others to a marked person.     Detailed studies have documented lower self-esteem and difficulties with interpersonal     interactions in Port wine stains patients. Port wine stains are initially flat and red, but     with time, they tend to darken to purple and become thickened as vascular nodules develop.     This thickening occurs in approximately two-thirds of lesions and further disfigures the     facial features of many patients.   "
103995|NCT01924897|"     Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal     surgery team at the Norfolk and Norwich University Hospital and the University of East Anglia     to look at the role of exercise before surgery to improve recovery following an operation.      Having an operation to remove part of the bowel puts physical stress on the body. We know     that training can help the body cope with physical stress in the same way that an athlete     trains before a competition. We hypothesise that the body may recover more quickly if it is     trained prior to an operation with regular and simple exercises.      Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart     and muscles at rest and during exercise. CPET testing is often done as part of standard     pre-operative assessment in many hospitals for patients before undergoing major surgery. Some     studies have demonstrated that CPET can be used to predict outcomes following surgery (such     as time taken till discharge, complication rates).      The study consists of two parts:      Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test to     determine baseline fitness. Blood tests will be taken around the time of surgery to examine     whether biochemical markers in the bloodstream (when used in combination with results from     the CPET test) can predict outcomes and recovery following colorectal surgery. Patients will     then be monitored to assess their speed of recovery and rate of complications following     surgery.      This will enable us to determine which CPET variables or combination of variables are most     useful in the prediction of post-operative complications following colorectal surgery.      2) The second study will consist of an exercise intervention involving several sessions of     supervised exercise in a laboratory. Before and at the end the exercise training regime, CPET     measurements will be taken to see if fitness has improved with exercise.      This part of of the study is to determine if it is feasible to implement a structured,     supervised exercise programme for patients awaiting elective colorectal cancer surgery. The     results of this study will be used to inform a larger randomised controlled trial to examine     the influence of exercise on CPET variables and postoperative outcomes.   "
103981|NCT01925079|"     Among the patients with coronary heart disease, those with ACS (acute coronary syndrome) are     extremely high-risk patients. Therefore, management outside hospital, especially the regular     administration of drugs, is vital to prevent the recurrence of cardiovascular events.     However, most patients often fail to stay on a long-term administration regimen, especially     the administration of statins. According to the statistics, the average duration adhered with     statin in patients with ACS is less than 3 months, use of statin at hospital discharge was     only 80% and 65% in 6 month, with a very low LDL-C control rate (about 11% at 6 months),     which poses a threat to the recurrence rate of cardiovascular events in patients with ACS.      It was found in previous studies that there were many factors influencing patients'     compliance, in which patients' refusing to take medicine accounted for a higher proportion.     It suggests that patient had not recognized the importance of long-term administration.     Therefore, it is extremely important for physicians to strengthen patient education and     regular follow-up visits during disease management. Moreover, the effectiveness of patient     education during chronic disease management has already been proved in some studies abroad,     and the interventional effect of multiple patient education process outweighs that of single     approach education.      Thus, we intend to conduct a randomized and controlled study to explore the effect of     multi-channel intensive patient education on LDL-C target achieving rate and statin adherence     in patients with ACS in China.   "
103982|NCT01925066|"     The purpose of this study is to determine whether aerosolized vancomycin is effective in the     treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical     ventilation.   "
103983|NCT01925053|"     This exploratory study is designed to compare the gastric layering and rates of emptying and     by inference rates of digestion of a Palaeolithic inspired meal and a reference meal. Two     types of meals, one high in fruit and vegetables will be used, and one based on WHO     nutritional guidelines. Previous data suggests that the former meal releases nutrients more     slowly than the latter. On each of two study days, a total of 11 MRI scans will be taken, 1     baseline and 10 post meal, to assess gastric layering and emptying. Participants will also be     asked to complete a questionnaire at predetermined times to assess feelings of satiation.   "
103984|NCT01925040|"     The purpose of this study is to compare the clinical performance of a new resin based filling     material to an established resin-based filling material in posterior teeth at 2 different     study centers.   "
103985|NCT01925027|"     Our hypothesis is to test that 1) The safety and efficacy of Nano+ DES in patients with de     novo lesions; 2) A low neointimal hyperplasia after Nano+ DES implantation due to its     effective and sufficient antiproliferative drug; 3) A very high coverage and an improved     early arterial healing after Nano+ DES implantation due to polymer-free; 4) The safety of     clopidogrel treatment discontinuation at 3 months when OCT results are defined as optimal.   "
103986|NCT01925014|"     To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed     tomography (CT) as the first-line imaging test in adolescents and young adults in regard to     negative appendectomy rate (NAR).   "
103987|NCT01925001|"     Sickle Cell disease is caused by an inherited hemoglobin disorder. Healthy red blood cells     are discoid and can deform and move through small blood vessels to carry oxygen to all parts     of the body. In Sickle Cell disease, as red blood cells circulate and oxygen is released, the     deoxygenated abnormal Hemoglobin S can begin to polymerize and cause red cells to become     sticky and elongated. These sickled red cells are less flexible and will obstruct small     blood vessels and prevent normal red cells from circulating freely, which limits oxygen     delivery to tissues and organs. This is known as a sickling crisis or vaso-occlusive     crisis and is the leading cause of hospitalization in patients with Sickle Cell disease.      Patients suffering from a sickle crisis experience severe pain and are at risk of stroke,     heart attack or even death. Current therapy is limited to hydration and symptomatic pain     relief. The administration of MP4CO as an adjunct treatment to standard therapy may alleviate     pain associated with a sickling crisis and potentially reduce the severity and duration of a     crisis. This may shorten the time in hospital and potentially improve the quality of life for     patients with sickle cell anemia.   "
103988|NCT01924988|"     This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption     protocol, with the primary goal of determining the safety of prostatic artery embolization     (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side     effects, particularly bladder and rectal complications, which may occur as a result of this     procedure. Secondarily, the study will provide preliminary data to determine its     effectiveness in diminishing obstructive symptoms associated with BPH.   "
103989|NCT01924975|"     The purpose of this study is to compare the two different saphenous vein cannulation     techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional     landmark technique (Landmark group).   "
103990|NCT01924962|"     The study is a randomised comparison of recanalisation of chronic occluded coronary arteries     with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and     scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the     superiority of medical therapy over revascularisation.   "
103991|NCT01924949|"     This study is to evaluate the antiviral efficacy, safety, and tolerability of     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial     genotype 1 hepatitis C virus (HCV) infection.   "
103992|NCT01924936|"     In the United States in 2010, 38,000 people died from suicide and it is our nation's 10     leading cause of death. Suicide prevention is a national priority and yet secondary     prevention programs targeting those most at risk are lacking. The purpose of the current     research is to develop and pilot test three promising suicide prevention programs that, if     found acceptable to high-risk individuals, could be further evaluated and eventually offered     broadly and affordably to the public.   "
103993|NCT01924923|"     This pilot study intends to investigate a new biopsy technique that will decrease the     incidence of tumor cells in the biopsy tract.   "
104184|NCT01922427|"     The purpose of this study is to see if use of RNS60 during ACL reconstruction surgery     decreases pain and improves functional capacity post-operation.   "
104185|NCT01922414|"     This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in     disintegration of staghorn stones during percutaneous nephrolithotomy.   "
104186|NCT01922401|"     for evaluating inverse ratio ventilation of laparoscopic bariatric surgery   "
103996|NCT01924884|"     The goal of this study is to present a large single-institution experience reporting surgical     site infection rates in patients who have undergone intra-abdominal surgery followed by wound     closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will     be conducted to analyze surgical site infection rates between wound closure with and without     Negative Pressure Wound Therapy (NPWT). American College of Surgeons National Quality     Improvement Program data from previous standard of care (primary closure after colorectal     surgery) will be used for comparison with newly adopted standard of care treatment regimen     (wound closure with NPWT).      Data on patients who underwent intra-abdominal surgery will be retrospectively collected and     a database will be created. These individuals will be identified through medical records and     recontacted by mail and/or phone to collect study data.      Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery     will be enrolled in the database. After giving informed consent, data on surgical site     infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30     days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to     a group of patients treated by the Principal Investigator who also underwent intra-abdominal     surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated     with negative pressure wound therapy following intra-abdominal surgery will develop surgical     site infections than patients who had intra-abdominal surgery but were not treated with     Negative Pressure Wound Therapy.   "
103997|NCT01924871|"     It has been reported that deep extubation can reduce cardiopulmonary complication against     endotracheal tube extubation during emergence from general anesthesia. The investigators     hypothesized that using desflurane with target controlled infusion of remifentanil is more     effective than using desflurane alone during deep extubation. The purpose of this study is to     evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing)     during emergence from general anesthesia.   "
103998|NCT01924858|"     This is an open label, PET study in healthy male subjects to determine if GSK2647544 is able     to cross the blood-brain-barrier. The study will use GSK2647544 radiolabelled with     fluorine-18 ([18F] GSK2647544) to determine the ratio of the concentration of the compound in     tissue to that in plasma at equilibrium, expressed as the PET volume of distribution (VT).     The study will consist of at least four visits; 2 screening visits, scanning day and     follow-up. On Day 1 (scanning day) the subject will receive a single oral dose of GSK2647544     (100 mg) followed approximately 2 hours later by a single intravenous (IV) infusion of     [18F]-GSK2647544 and a dynamic PET scan. Arterial and venous blood sampling will be used to     determine the plasma kinetics of [18F]-GSK2647544 and unlabeled GSK2647544. In addition, each     subject will undergo a structural magnetic resonance imaging (MRI) scan of the brain to aid     in the definition of neuroanatomy. The dose of GSK2647544 was selected based on the review of     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) data obtained in     the first time in human (FTIH) study.   "
103999|NCT01924845|"     Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe     disease who have been receiving treatment with recombinant human acid alpha-glucosidase     (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to moderate respiratory     impairment will switch directly to receive BMN 701 20 mg/kg by IV infusion every other week.     All participants will receive active drug. No dose of existing therapy will be missed -     experimental drug is started immediately.   "
104000|NCT01924832|"     The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of     monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part     1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.     The secondary objective of this study is to evaluate the safety and tolerability profile     following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying     regions within the GI tract in healthy volunteers.   "
104001|NCT01924819|"     Gastric cancer remains a significant global public health problem. Although in developed     countries its incidence has dramatically decreased, on a worldwide scale it is still a     leading cause of cancer-related deaths. Surgery is the only potentially curative treatment     for gastric cancer. Although the survival rates for patients with early stage disease (stage     1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing     resection. The majority of patients will have locally advanced or metastatic disease at     presentation, which has an extremely poor prognosis. The current five-year survival rate for     gastric cancer in Western countries is approximately 20-30%, a figure that has improved     little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative     chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The     control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy.     The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy     to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving     pathological complete response rates in the first instance, and subsequently overall     survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric     cancer.   "
104002|NCT01924806|"     A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention   "
104004|NCT01924780|"     This will be a two-stage study to test whether t-VNS using the NEMOS device can activate the     CAP and reduce markers of systemic inflammation. Stage A (healthy volunteers) stage B     (patients with Juvenile Idiopathic Arthritis).      Stage A: healthy human volunteers. A randomized, single blind, three-period crossover design     comparing the CAP activation effect of 10 minutes (active) versus 60 minutes (active) versus     10 minutes (sham) stimulation with the NEMOS device. CAP activation will be assessed by     reduction in the in vitro release of LPS-inducible cytokines from whole blood.      Analysis of the reduction in whole blood cytokine release assay after 10 versus 60 minutes of     stimulation, and the kinetics of the nadir of the whole blood cytokine release assay will     inform the selection of dose duration and sampling time for Stage B. Performing this more     extensive exploration of dose duration and kinetics in adults will allow one dose, and a     single optimal sampling time in the JIA patients, thus minimizing blood drawing and     discomfort in these children.      Stage B will be performed in patients with JIA. This will be an open label design examining     the effect of the optimal dose duration (either 10 minutes or 60 minutes of stimulation, as     determined by results of Stage A). All information regarding Stage B will be registered in a     separate registration at clincialtrials.gov. in order to keep accuracy. All details below     concerns only Stage A.   "
104007|NCT01924741|"     Recently a new method of induce similar hypertrophy in the liver as is observed after     hepatectomy has been described and was given the eponym ALLPS. ALPPS stands for     Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS).      Since the procedure is used worldwide this international registry was created to enable     tracking of cases performed worldwide for safety and outcomes and innovations by the groups     involved as well as allows a non-randomized comparison to the conventional methods of portal     vein occlusion.   "
104008|NCT01924728|"     The aim of the study is to investigate the effects of QRS®-1010 PelviCenter in female     patients with stress urinary incontinence.      Based on the available data on magnetic stimulation, the investigators hypothesize that     magnetic stimulation via QRS®-1010 PelviCenter will reduce the number and amount of urinary     leakage upon exertion as well as improve patients' quality of life.   "
104009|NCT01924715|"     Objective: To evaluate whether or not cases treated with Intensive Short-term Dynamic     Psychotherapy (ISTDP) facilitate healthcare cost reduction, whether any observed reduction is     greater than that of a control group and whether any such gains would be maintained in follow     up.      Design: A quasi-experimental design was employed in which pre and post healthcare cost and     usage data were extracted for all ISTDP treated cases from 1999 to 2008 and compared to     parallel measures of a control group of cases referred but never treated.   "
104010|NCT01924702|"     The purpose of this study is to determine if non-invasive electrical brain stimulation can     enhance the outcome of intensive language therapy in chronic aphasia.   "
104011|NCT01924689|"     This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT     spores in patients with treatment-refractory solid tumor malignancies. This investigational     study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients     with treatment-refractory solid tumor malignancies.   "
104012|NCT01924676|"     To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg     doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to     PF-00345439 Formulation X in the fasted state in healthy volunteers   "
104013|NCT01924663|"     The purpose of this study is to be able to better describe the incidence, timing and severity     of myocardial dysfunction and acute kidney injury (AKI) following a documented respiratory     viral illness (RSV, adenovirus, metapneumovirus, parainfluenza, influenza, etc.) in pediatric     patients.   "
104014|NCT01924650|"     The purpose of this study is to investigate the effects of varying particle size on the     pharmacokinetics of PH-797804   "
104015|NCT01924637|"     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the     investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects     with type 1 diabetes.   "
104016|NCT01924624|"     Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical     resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven     effective in preventing or delaying recurrence. The aim of this prospective randomized study     was to evaluate the effectiveness of Thalidomide as a postoperative adjuvant regimen in     inhibiting the recurrence of HCC   "
104017|NCT01924611|"     AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate     of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both     genders, were selected having one primary molar with a proximal dentine lesion. The children     were randomly divided into two groups: a control group with class II ART restoration made     using cotton rolls and an experimental group using rubber dam. The restorations were made and     they were followed up every six months. After two years, the results were compilated and     analyzed.   "
104026|NCT01924494|"     Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy     by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital based     endoscopy unit. EndoAlpha will be used on the hospitals existing Intranet/LAN and the     possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line     or through new established transmission lines, will be evaluated. The EndoAlpha system will     be integrated in a highly advanced endoscopy procedure room. The system will integrate     through LAN with doctor office, clinic conference and lecture room and GI pathologist room.     Through either LAN or WAN, connection will be establish to a referral GI center in Denmark.     Through WAN, connection will be established to doctor home and to an expert Spanish center.   "
104018|NCT01924598|"     Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of     effective treatments. AN becomes intractable in around 20%, resulting in huge individual and     healthcare costs. Exploration of underlying processes and novel treatment strategies is thus     crucial. This is a pilot study of a novel translational approach to the investigation and     treatment of severe AN. The aims are (1) to explore the safety, acceptability and feasibility     of Deep Brain Stimulation (DBS) for AN (2) to map neural mechanisms underpinning aberrant     reward and optimise DBS targets. The study will involve 6 consenting adults with full mental     capacity, and will last 15 months. It incorporates an ethical substudy including assessment     of capacity and informed consent. It combines complementary forms of cutting edge     neuroimaging including fMRI and MEG (magnetoencephalography). These will be complimentary in     helping identify the best strategy for treating severe AN using DBS. Individuals with severe     intractable AN will be eligible to take part. The study will be conducted in Oxford, United     Kingdom at the John Radcliffe and Warneford Hospitals. The individuals will have preoperative     ethical, neuroimaging and psychological assessments, A DBS operation in month 2, DBS switch     on in month 3 month postoperatively . DBS will be targeted to the Nucleus accumbens, followed     by a 12 month post switch on follow-up period with monthly joint neurosurgical psychiatric     and psychological assessments and postoperative MEG scans . The study will further our     understanding of food reward processes in general and AN in particular indeed promises to     provide important information which may revolutionize future treatments. The proposal builds     upon a body of research investigating the role of aberrant reward processes in AN and     exploits our complementary research experience in AN using experimental behavioural     strategies, fMRI , MEG and DBS to establish a powerful translational research strategy.   "
104044|NCT01924260|"     This phase I trial studies the side effects and the best dose of alisertib when given     together with gemcitabine hydrochloride in treating patients with solid tumors or pancreatic     cancer that is metastatic or cannot be removed by surgery. Alisertib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving alisertib     with gemcitabine hydrochloride may be an effective treatment for solid tumors or pancreatic     cancer.   "
118456|NCT01735474|"     The main objective of this study is to evaluate the effectiveness of different manual     techniques included traditionally on respiratory physical therapy   "
104019|NCT01924585|"     Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years     and older undergoing major colorectal surgery. That is to say we are looking at how older     patients recovery following surgery, and that patients who volunteer to take part will     absolutely not have any changes made to patients planned treatment or surgery.      Patients (identified by their Consultant) will be asked if they would like to participate in     the study, agreeing to undertake an additional questionnaire, blood test, provide a urine     specimen and several basic physical tests during the pre-assessment visit taking an     additional 30-45 minutes.      This will not affect their treatment in any way. Participation is voluntary.      At the time of the pre-assessment process the patient will then be approached by a     researcher, who will explain the study in more detail and obtain written consent.      The questionnaire is a combination of questions, which have been used in other similar     studies and may be used to identify people who are fitter than others to undergo surgery.     These questions are not too dissimilar to those that may be asked during the pre-assessment     process. In fact some hospitals use some of these questions (but not usually all) routinely     during a hospital admission process.      Several basic physical tests will be performed: hand grip strength test and some basic     walking and chair rising tests. These will be supervised by the trained researcher to ensure     they are carried out safely.      A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for     the standard pre-operative assessment process. We will also take urine specimens. The blood     sample and urine specimens will be saved for tests later. There are several potential blood     and urine tests that may be related to physical frailty/impairment and the aging process.      The patient will undergo surgery as planned and be discharged from hospital. No researcher     will interfere with the planned care or conduct any data collection at this point.      At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to     complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at the     time of their postoperative follow-up checks, then we will repeat the basic physical tests     again also.      The patient's notes will be reviewed by a researcher (who is also a doctor) to see what     operation was performed, the length of hospital stay, and if any problems developed. The     patients GP may also be contacted if additional information is required.      This study, while based on several others, is the first of its kind to see how persons     recover after surgery being assessed over one year.      We will recruit for 18 months across two hospitals aiming to recruit 200 patients during this     time.   "
104020|NCT01924572|"     The proposed study is a pilot prospective controlled trial to measure the blood volume left     in the placenta after varying cord clamping times when the infant is placed skin-to-skin on     the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants.     However, the best way to get the most blood to the baby is not known. The practice of cord     clamping at birth is not the same among doctors and midwives and we do not know the effect of     putting he baby on the mother's abdomen.   "
104021|NCT01924559|"     We will investigate the impact biohazard gear has on time to successful intubation and, in     particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus,     Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video)     intubation techniques.   "
104022|NCT01924546|"     There is a large body of evidence from adult populations suggesting cognition in adults is     affected by hydration status. The few studies conducted in the global North in populations of     schoolchildren indicate that drinking water has an impact on pupil performance on basic     cognitive tasks. No studies assessing the impact of dehydration and cognition in     schoolchildren have been published in the global South, where access to water is the poorest     and dehydration prevalence is likely higher. Our group previously carried out research on     this topic in Mali, and will build upon findings from that work with this trial. This study     will examine the effect of drinking supplementary water during the school day on hydration     status and on cognitive test scores in schoolchildren in Zambia.      The investigators hypothesize that providing supplemental water will result in a decrease in     prevalence of dehydration in the study group and will result in an improved performance on     cognitive test scores.      Data will be collected from up to four purposively-selected schools in the region of Zambia     where this study is taking place, from up to a total of 400 children. At each school pupils     in grades 3-6 will be eligible for recruitment, dependent upon their understanding of     research instructions. Research staff will explain the study to pupils at the school and     individually request informed oral assent for participation. A waiver of parental consent for     pupil interviews will be secured from the Ministry of Education. At each school, school     directors will be asked to sign in loco parentis (in the place of parent) on behalf of the     pupil participants.      Children that assent to participate in the study will be randomly allocated to the     intervention or control group. In the intervention group, study participants will receive     supplementary water in the morning. In the control group, study participants will receive     supplementary water in the afternoon. Testing procedures in both groups is identical and will     include a five-minute interview, two cognitive testing sessions of 45 minutes each, and     collection of two urine samples during the day. None of these activities collect personal     data or identifiers, and the urine sample will not be stored.      All data collection will occur at the school and will be conducted by trained local     enumerators. There are no risks to participation other than a small amount of class time     missed by pupils, and great efforts will be made to minimize time outside of class.   "
104023|NCT01924533|"     This study is a phase III, multi-centre study of olaparib in combination with paclitaxel,     compared with placebo in combination with paclitaxel in patients with advanced gastric cancer     who have progressed following first-line therapy. Patients will be from China, Japan , Korea     and Taiwan.   "
104024|NCT01924520|"     A study was to evaluate the safety and plasma concentration changes of quetiapine after     repeated administration of FK949E (extended-release formulation of quetiapine) in patients     with major depressive disorder (MDD).   "
104025|NCT01924507|"     The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology     intensive care unit. The patients will be submitted to a overnight polysomnography. Those     individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the     investigators will identify the factors that compromise the sleep and will act to minimize     them to improve the sleep quality.      After the interventions, the investigators will evaluate if there are reduced days of     hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and     stroke) and overall mortality.   "
104041|NCT01924299|"     The main purpose of this study is to look at the effect of ketoconazole and fluconazole on     how much baricitinib gets into the blood stream. The study will also look at the tolerability     of baricitinib and ketoconazole when given together and the tolerability of baricitinib and     fluconazole when given together.      Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each     treatment group will participate in 2 study periods. Participants will take baricitinib alone     in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This     study will last approximately 7 weeks.   "
104027|NCT01924481|"     The Hershey Company is interested in investigating the effects of various chocolate beverages     on brain physiology and cognitive function. The main substances in the drinks that are known     to influence the brain are caffeine (and related chemicals such as theobromine) and     flavonoids. Flavonoids are chemical found in plants and are most commonly associated with     antioxidant activity. Caffeine, chemicals related to caffeine, and flavonoids are all     naturally occurring and all potentially alter brain physiology. This study will evaluate     changes in brain blood flow and cognition following the consumption of drinks with various     combinations of the Primary Ingredients. Caffeine is likely to have peak effects within     1-hour of ingesting the chocolate while the flavonoids are likely to have peak effects 3-4     hours after ingestion. The study proposed here will evaluate ingredients in a 4-arm     cross-over double-blind design in an attempt to understand the differential effects of these     compounds in chocolate drinks.   "
104061|NCT01924039|"     The investigators are proposing a project that will examine the effectiveness of brief     motivational enhancement therapy in a population with concurrent psychotic disorders and     substance use disorders. This study will represent an emerging line of inquiry, as best     practice interventions with this concurrent disordered (CD) populations are yet to be     established.   "
104028|NCT01924468|"     Background:      - The risk for becoming addicted to drugs varies from person to person, even among those     using similar drugs in a similar way. Researchers do not fully understand why some people     become addicted to drugs and others do not. Studies suggest that under certain life     circumstances, some genes may increase the risk for addiction. This study will use genetic     information, computer tasks, magnetic resonance imaging (MRI), and other tests to see what     brain networks may be related to drug addiction.      Objectives:      - To better understand brain networks that may be related to susceptibility to drug     addiction.      Eligibility:      - Healthy non-smoking volunteers between 18 and 55 years of age.      Design:        -  This study will have one screening visit and four all-day study visits. For male          participants, the visits will be about 7 days apart over 5 to 7 weeks. Female          participants will have the visits scheduled to coordinate with their menstrual cycle.        -  This study involves small doses of three approved drugs: two oral dopamine drugs and a          nicotine patch. For each scanning session, participants will have three study drugs.          However, only one pill or patch will be the real drug; the other two will be placebos.          Some participants may have only placebos during a visit.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be taken. Other tests will be given to ensure that participants are not          smoking or using drugs while they are in the study.        -  During the all-day scanning visits, participants will receive two pills and one patch in          the morning and they will be trained on simple computer tasks. In the afternoon,          participants will have MRI scans and we will measure their brain activity while they          rest and while they perform computer tasks in the scanner. Participants will also answer          questionnaires during the scanning visits.   "
104029|NCT01924455|"     Despite effective ART that can suppress both HIV and HBV, HBV-related liver disease remains a     significant co-morbidity in this population. Little is known about the histologic spectrum of     liver disease, the significance of complete vs. incomplete HBV suppression, the utility of     novel virologic and serum markers of disease severity, and the long-term renal and bone     effects of TDF-based therapy. This proposal will address these important questions and impact     the science and health of those coinfected with HBV-HIV.   "
104030|NCT01924442|"     The Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) Trial (CSP #517) was     funded in 2001. ROOBY was designed to compare the short-term (30-day) and intermediate-term     (1-year) outcomes for patients undergoing off-pump versus on-pump coronary artery bypass     graft (CABG) procedures. The ROOBY trial reported a significantly higher 1-year adverse     composite outcome rate (i.e., all-cause death, non-fatal myocardial infarction (MI) and/or     repeat revascularization) for off-pump versus on-pump patients. ROOBY documented that a     higher percentage of off-pump patients received fewer grafts than originally planned (i.e.,     off-pump patients were less completely revascularized) as compared to on-pump patients.     Across all anatomic regions of the heart, the 1-year graft patency rates were significantly     lower for off-pump CABG patients. Based on these ROOBY trial initial findings, critically     important clinical questions related to the long-term efficacy, stability and durability of     the off-pump versus on-pump techniques have been raised. Extending the original ROOBY trial,     this CSP #517 follow-up study (CSP 517-FS) will evaluate the longer-term impact of off-pump     versus on-pump surgical approaches upon the future occurrence of major adverse cardiovascular     events (MACE).   "
104031|NCT01924429|"     The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication     used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity     in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for     participation in this study because they have ADHD and are willing to participate in two     Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their     symptoms. Another purpose of this study is to collect and bank samples of blood for research     to examine how genes influence brain activation seen during the brain scans. The study also     seeks to find out whether certain genes are related to ADHD. Participants' entire genetic     makeup will not be determined from this sample.   "
104032|NCT01924416|"     The primary specific aim is to test the hypothesis that use of a decision aid to enhance     informed, shared decision making coupled with quality of life assessment in patients with     advanced lung cancer receiving first-, second-, or third-line therapy will lead to a     reduction in two major contributors of cost (number of chemotherapy cycles; number of     advanced imaging studies) compared with the control arm.   "
104033|NCT01924403|"     This study will assess which of the three most common methods of wound closure in primary     total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular     suture) provide the best wound vascular perfusion. This can be achieve by using SPY     intra-operative vascular angiography, which is commonly used in clinical practice to assess     perfusion of wound closure at the clinic. By understanding the differences in perfusion     afforded by different closure techniques, surgeons will then be able to select the technique     that optimizes this parameter so as to avoid complications such as tissue necrosis, wound     dehiscence, or infection.   "
104042|NCT01924286|"     Tuberculosis (TB) is the most common opportunistic infection amongst HIV-infected patients     starting antiretroviral therapy (ART) in developing countries and thus the most frequent form     of immune reconstitution inflammatory syndrome (IRIS). Paradoxical TB-IRIS occurs in 8- 43%     of patients starting ART while on TB treatment and results in morbidity, hospitalisation,     consumes health care resources and TB-IRIS may be fatal. We have previously demonstrated in a     clinical trial that prednisone reduces morbidity when used for treatment of paradoxical     TB-IRIS. This trial is a double-blind placebo-controlled trial of prophylactic prednisone     (40mg/day for 2 weeks followed by 20mg/day for 2 weeks, started on the same day as ART) in     patients with TB who are identified as being at high risk for paradoxical TB-IRIS (starting     ART within 30 days of initiating TB treatment and CD4 < 100/μL). The trial will enroll 240     participants, randomised 1:1 (prednisone:placebo). The primary endpoint is development of     paradoxical TB-IRIS, defined using international consensus case definitions. Secondary     endpoints include time to IRIS event, severity of IRIS, quality of life assessment, mortality     and corticosteroids adverse events. The trial is powered to determine a reduction in TB-IRIS     events.   "
104059|NCT01924065|"     Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo     transesophageal echocardiography or they will receive warfarin for 3 weeks with an     international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use     warfarin will be given an approved new oral anticoagulant agent istead of warfarin for 3     weeks.      If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be     performed. Other patients in the both groups will undergo electrical cardioversion. After the     procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All     patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at     baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic     events detected by diffusion MRI will be recorded. Any bleeding events during this period     will also be recorded.   "
104034|NCT01924390|"     This entire protocol involves procedures that are standard care. The purpose of the research     is to evaluate whether there are any differences in new bone formation following tooth     extraction and grafting of the extraction socket with either 100% mineralized FDBA (FDBA) or     a combination of 70% mineralized & 30% demineralized FDBA (DFDBA). Both FDBA and DFDBA are     commonly used in dentistry for this purpose. Until recently, there has been no human evidence     of differences in new bone formation with one material versus another. Recently, DFDBA has     been shown to provide a greater percentage of vital bone formation than FDBA. No studies have     been done on materials that provide a combination of demineralized and mineralized FDBA for     ridge preservation. That is the purpose of this study.      There will be two subject groups in this study. All subjects will require extraction of at     least one non-molar tooth, followed by replacement of the missing teeth with dental implants.     Each group will have 22 subjects. The primary distinction between groups will be the use of     either a combination of 70% mineralized & 30% demineralized FDBA or 100% mineralized FDBA:     Group 1 will have 70% mineralized & 30% demineralized FDBA grafted into the extraction socket     for ridge preservation. Group 2 will have 100% mineralized FDBA grafted into the extraction     socket for ridge preservation. The allocation of subjects into group 1 or 2 will based on     numbers drawn from a stack of sealed envelopes. A small flap will be reflected to an extent     about 3-4mm beyond the bony walls of the socket. A measuring stent will be placed and     measurements of ridge width and ridge height will be taken and recorded to the nearest 0.5mm.     Ridge width will be measured using a ridge caliper at a point approximately 4mm apical to the     facial and lingual bony crest. Ridge height will also be measured. The tooth will be     extracted and the subject will then be randomized by drawing a sealed envelope from the     stack. Either 100% mineralized FDBA or a combination of 70% mineralized & 30% demineralized     FDBA will be placed in the socket to restore the ridge to appropriate contour. A dense     polytetrafluoroethylene (PTFE) membrane will then be placed over the socket orifice extending     about 3mm beyond the bony socket walls. A PTFE suture will be placed over the membrane to     secure it in place. Primary closure will not be attempted. The patient will be seen 7-10 days     after extraction/ridge preservation to assess healing. The subject will be seen again 21-28     days to remove the PTFE membrane and to assess clinical healing.      At the time of implant placement, the measuring stent and caliper will be used to determine     the ridge width and ridge height again. The implant site will be prepared using a hollow     trephine which allows retention of the bony core. The bone removed from the osteotomy site     remaining in the trephine will be prepared for histologic examination and analyzed for new     bone growth. The following histologic parameters will be measured: percent vital bone     formation; percent residual graft material; and, percent nonmineralized connective     tissue/bone marrow. Following initial preparation of the implant site with the trephine, an     implant of the appropriate length and diameter will be placed. A healing abutment will then     be placed. All subjects will be examined at 7-10 days following implant placement. The study     will end at the time of this follow up visit. The patient will then be referred to his/her     restorative dentist for final restoration.   "
104035|NCT01924377|"     Recent clinical studies have shown that atrial fibrillation (AF) in humans might be sustained     by localized sources called mother rotors which exhibit persistent, fast, and well     organized activity during AF and play an important role in the generation and maintenance of     the fibrillatory activity. In this study, investigators aim to identify the     electrophysiological characteristics of mother rotors during atrial fibrillation in patients     with paroxysmal and persistent AF and to test whether ablation of such patient-specific     substrates might improve the acute and long-term success of conventional catheter ablation     therapy.   "
104036|NCT01924364|"     The overall purpose of this research is to evaluate the physical changes that occur over time     after fat grafting for craniofacial trauma. This protocol is similar to an existing study     (IRB# PRO0906101) presently conducted at the University of Pittsburgh by the same research     team which utilizes fat grafts. The preparation of the fat graft material in each clinical     trial is processed differently evaluating the effects of graft resorption after treatment.   "
104037|NCT01924351|"     Primary Objective:      To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a     6-month distant brain relapse rate of less than 30%.      Secondary Objectives:        1. Describe the natural history of neurocognitive function for women with brain metastases          treated with SRS and HER-2 directed systemic therapy and establish a reference benchmark          to generate hypothesis for future design of a phase III trial.        2. Describe patterns of distant brain relapse after SRS for all patients and compare them          between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients treated          with each systemic therapy regimen        3. Describe patterns of neurologic death        4. Describe patterns of local brain relapse        5. Describe patterns of re-irradiation with WBRT or SRS        6. Describe adverse events   "
104038|NCT01924338|"     The study is intended to verify a newly developed method to measure the thickness of cranial     soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser     scan of the forehead. The laser scan is acquired point by point with a prototype scanning     unit developed at the University of Luebeck's Institute for Robotics.      The measured tissue thickness using the near-infrared scanning approach is validated against     the ground truth obtained by the MRI scan. The average accuracy of the reconstruction method     is then computed over all subjects from the individual study arms.      The required laser intensity and exposure time as well as the achieved measurement accuracy     is evaluated with respect to the different skin types of the test subjects. Correlation     between these features and the skin type according to the Fitzpatrick scale will be computed.      For 1/3 of the subjects, the laser and MRI scans are repeated after 2 and 8 weeks. The     results of the scans are compared and time dependency is analysed.   "
104039|NCT01924325|"     Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease     with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin     treatment reduced the risk of recurrent stroke and was not associated with increased     hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is     proved to be as effective as traditional anticoagulants with less risk of bleeding events.      To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized,     double-blind, multicenter, controlled clinical trial has been designed. The investigators     will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and     aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling     cerebrovascular event.   "
104040|NCT01924312|"     Vascular risk factors may account for up to 80% of the memory and thinking problems     experienced by our aging population today, by far in excess of that caused by Alzheimer's     disease. By doing this study, we hope to learn how vascular risk factors cause memory and     thinking changes in the elderly, and whether we can prevent memory and thinking changes by     reducing these risk factors. Successful completion of project aims will allow an integrated     understanding of mild cognitive impairment caused by vascular risks (MCI-CVD) with the     potential for tremendous impact on one of the major healthcare crises facing the nation     today.      The study will enroll 80 participants with memory and thinking problems (mild cognitive     impairment; MCI) and are at risk for stroke and further difficulties with memory and thinking     that may eventually lead to disability and a diagnosis of dementia. Each participant will be     randomized into one of two groups (40 in each group) and followed over 36 months. One group     will be followed to allow us to understand the natural history of memory and thinking     impairment, while the other group will receive intensive education and assistance with     vascular risk factor (CVD) control.   "
104187|NCT01922388|"     Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical     treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is     lacking. This study is intended to demonstrate that early, compared with delayed,     introduction of STN DBS is more beneficial for PD patients who have developed motor     complications.   "
104045|NCT01924247|"     Background:      Stroke represents one of the major health problems worldwide, particularly in transitional     and industrialized countries. Stroke has a remarkable socioeconomic impact, especially in the     ageing population, and therefore stroke prevention is important. Secondary preventive     measures and rehabilitation are essential for reduction of recurrent events. However, to date     appropriate secondary preventive programs for patients surviving a stroke with minor or no     residual deficits have been poorly studied.      Specific aims/projects:      The aim of this study is to validate the effects of an outpatient secondary prevention     program on vascular risk factors, adherence to vascular-protective medication, exercise     capacity and health related quality of life.      Working Hypothesis:      The outpatient rehabilitation program results in a significant short (3 months) and long-term     (1 year) improvement of vascular risk factors, neurological functions, exercise capacity,     adherence to vasoprotective medication and health related quality of life.      Experimental design/Methods:      This is a prospective, randomized clinical trial. At least 100 patients will be randomized     either to the interventional group or to a group which is treated only by the family     physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary     outcome is the number of reached cardiovascular health goals (6 metrics) between the     interventional group and the group which is treated only by the family physician.      Expected value of the proposed project:      The study has the potential to show that an outpatient rehabilitation program significantly     improves vascular risk factors, adherence to medication, enhances quality of life and     eventually reduces recurrent strokes and other vascular events. If this is confirmed,     introducing outpatient rehabilitation programs will have a major socioeconomic impact.   "
104046|NCT01924234|"     The purpose of the study is to determine whether remifentanil influence the pharyngeal phase     of swallowing using using pressure and impedance recordings. The purpose is also to compare     remifentanil to morphine and younger to elderly volunteers.   "
104047|NCT01924221|"     Cardiac resynchronization therapy with pacemaker alone, or in combination with a     cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in     patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS     duration 6 months after cardiac resynchronization therapy. Such fenomenon is called reverse     electrical remodeling of native conduction. Retrospective analysis showed that reverse     electrical remodeling of the native conduction after at least 6 months of CRT is associated     with decreased rate of ventricular arrhythmias and better survival. This study is designed to     study reverse electrical remodeling prospectively.   "
104048|NCT01924208|"     Hypotheses        1. Immunotherapy induces tolerogenic effects to allergens in T cell regulation in tonsils.        2. Influenza vaccination induces a strong interferon response and decreases Th2 response in          tonsils.        3. Influenza vaccination as an adjuvant on immunotherapy induces a better response to          immunotherapy.   "
104049|NCT01924195|"     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance     to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of     andvanced non-small cell lung cancer who failed two lines of chemotherapy   "
104050|NCT01924182|"     This study compares two different ways to treat pain. The two ways are:        1. continuing to take current pain medication(s) or        2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your          body) that is implanted.      None of the procedures or products used in this study are experimental. The length the study     will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare     pain and opioid side effects between people who get a drug pump and people who do not get a     drug pump that will stay on their current pain medication treatment.   "
104051|NCT01924169|"     The goal of this clinical research study is to learn if lenalidomide can increase the level     of immunoglobulins (parts of the blood that may help to improve the immune system's function)     and/or will improve the protective effect of the flu and pneumonia vaccines in patients with     CLL.   "
104052|NCT01924156|"     The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells     (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell     carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express     MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously     performed preclinical study with DC vaccine combined with CIK cells, the investigators plan     to perform the clinical trial.   "
104053|NCT01924143|"     The purpose of the study is to evaluate the absorption, distribution, metabolism, and     excretion (ADME) of a single oral dose of [14C]TD-9855   "
104054|NCT01924130|"     The purpose of this study is to develop and evaluate the effects of a school breakfast policy     initiative (SBPI) on the incidence of overweight and obesity as well as breakfast patterns     (both inside and outside of school) among 4th-6th grade children. The study integrates     research, education and extension to promote healthy breakfast consumption among low-income     children in urban schools and will leverage ongoing SNAP-Ed and the School Breakfast Program     efforts.   "
104055|NCT01924117|"     Objective: Determine the genotypes and risk factors associated with human papilloma virus     infection in Mexican women.      Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital     Mónica Pretelini and the Medical Research Center (CICMED), who were asked to complete a     risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples     were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).   "
104056|NCT01924104|"     The purpose of the study is to determine whether low-dose aspirin and low molecular weight     heparin improve the implantation and pregnancy rates in patients with repeated implantation     failures in IVF cycle.   "
104057|NCT01924091|"     To compare drug concentrations in vaginal fluid, genital tissue, and blood   "
104058|NCT01924078|"     The present study is to determine the adverse effects and clinical efficacy of AI combined     with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with     Estrogen receptor and/or Progestrogen receptor positive.   "
105225|NCT01908790|"     The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter     that estimates venous oxygen saturation.   "
104060|NCT01924052|"     The investigators hypothesized that migraine without patients with many genetic loci     associated with migraine (high genetic load) would be more sensitive and get provoked more     migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few     genetic loci associated with migraine (low genetic load).   "
104547|NCT01917708|"     This is a single arm phase I study to assess the tolerability of abatacept when combined with     cyclosporine and mycophenolate mofetil as graft versus host disease prophylaxis in children     undergoing unrelated hematopoietic stem cell transplant for serious non-malignant diseases as     well as to assess the immunological effects of abatacept.   "
104062|NCT01924026|"     Phenylketonuria (PKU) is a genetic disorder known to cause severe reduction in intelligence     and deficits in cognitive function; it is associated with an elevated level of Phenylalanine     (Phe) in blood.      Newborn screening and early treatment with restricted protein diet supplemented by a formula     of amino-acids will preserve intelligence. In those with the severe form treated from birth,     some deficits that affect higher functions of the brain are seen.      Given this, there is disagreement about how milder forms of this disease should be managed     and what level of Phe is safe to be left untreated.      We seek to assess whether higher Phe levels, between 360 and 600µmol/L, are safe with respect     to preservation of intelligence and higher cognitive functions.   "
104063|NCT01924013|"     The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3     supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or     decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum     vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1     year of age among infants born to women who received vitamin D 28,000 U/week during     pregnancy. Infants enrolled in the study will be followed for 2 years to document the     persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300     pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be     randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000     IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be     additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months     postpartum. In addition to linear length, the trial will include analyses of inflammatory and     hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D     metabolism, and diarrheal and respiratory morbidity in the infants.   "
104064|NCT01924000|"     The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in     enhancement of eyebrows.   "
104065|NCT01923987|"     Radical treatment of primary rectal cancer with synchronous distant metastases includes     surgical resection of primary and metastatic lesion. However, primary rectal cancer in case     of metastasized disease are often locally advanced disease and need downsizing before     surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside     liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and     chemotherapy is used. However, the sequence of treatment modalities is not yet definitely     established and preoperative chemoradiotherapy and surgical resection is accepted as an     option of treatment. Conventional long course chemoradiotherapy delays administration of     full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In     present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by     full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.   "
104066|NCT01923974|"     A study investigating the analgesic effect of melatonin in a human heat injury model using     quantitative sensory testing.   "
104067|NCT01923961|"     An increase of the free fraction may allow a better removal of of protein-bound uremic toxins     during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl)     concentration will be increased in the infusion fluid at a target NaCl concentration and the     effect on the removal of protein-bound toxins will be determined. Comparisons will be made to     standard hemodialysis and hemodiafiltration.   "
104068|NCT01923948|"     Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing     partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine     consumption in the first 48 hours is documented. Postoperative pain is measured by the visual     analogue scale (VAS) score.   "
104069|NCT01923935|"     The purpose of this study is to determine whether intravenous busulfan and melphalan as a     conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous     stem cell transplantation.   "
104080|NCT01923792|"     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and     fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is     associated with poorer lung function, greater medication requirements and more asthma     symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is     evidence that HDMA leads to the development of asthma, in addition to exacerbating     pre-existing asthma in HDM-sensitised patients.      ToleroMune HDM is currently being developed for the treatment of HDM allergy.      The Purpose of this optional observational follow-on study is to evaluate the continued     efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline     approximately two years after the completion of the baseline EEC visit in TH002 following     challenge with HDM allergen in an EEC.   "
104513|NCT01918150|"     The purpose of this study is to compare the effectiveness and safety, at 24 months, of the     TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an     indication for these stents among 40% of which present an acute coronary syndrome (ACS).   "
104070|NCT01923922|"     High grade cerebral glioma is the most common primary brain tumor in adults and accounts for     about 2.5% of all cancer deaths. Brain tumor affects approximately 2300 individuals per year     in Canada. Noninvasive accurate and timely diagnosis is imperative.      High grade glioma is an aggressive neoplasm with median survival of 12 months, irrespective     of any treatment. The prognosis of these patients can only be decided based on pathology     after biopsy or surgery. Conventional imaging techniques, such as routine magnetic resonance     imaging(MRI), do not accurately predict the grade of malignancy of cerebral gliomas. Computed     tomography(CT) perfusion allows us to study the blood supply to the tumor at the level of     capillaries. This information permits determination of aggressiveness of cerebral gliomas at     the time of diagnosis.      In a preliminary study of 20 patients with high grade cerebral gliomas, we have shown that CT     perfusion can predict survival at the time of diagnosis irrespective of the pathological     grade and the treatment received. In the present study, we would like to extend our     preliminary findings in larger group of patients to ensure that this technique is indeed     robust. If our hypothesis was supported by our study, we will be able to subselect patients     based on initial imaging for more aggressive treatment. In patients with shorter survival,     the perfusion parameters may help in identifying new therapeutic targets (e.g.,     anti-angiogenic agents) that may help in the treatment of these patients.   "
120228|NCT01712217|"     The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in     Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.   "
104071|NCT01923909|"     Aim: To study and compare the clinical effects of platelet-rich plasma (PRP) injections and     intra-articular (IA) corticosteroid injections in patients with primary osteoarthritis (OA)     of the knee. This study aims to demonstrate this by using the Oxford Knee Score and Western     Ontario and McMaster Universities Arthritis Index (WOMAC) to illustrate quantifiable     difference between the two treatment modalities. Patient satisfaction will be compared by     utilizing the Short-Form Survey-12 (SF-12) Score. Our null hypothesis states that     intra-articular PRP injections is more beneficial in the long-term treatment of primary OA of     the knee.   "
104072|NCT01923896|"     The proposed study represents the first attempt to systematically investigate the use of DCS     as an adjunct to behavioral intervention to address chronic food aversion through an     randomized control drug trial in children treated at the Marcus Autism Center's Pediatrics     Feeding Disorders Program. This pilot and feasibility study will involve a total of 16     participants randomly assigned to experimental conditions: behavioral intervention or     behavioral intervention + DCS (8 in each group). All participants will receive the same     behavioral protocol involving three treatment sessions per day (45 minutes in length), for a     total of 15 sessions across five consecutive days. In addition, participants in the     behavioral intervention + DCS group will receive a low dose (0.7 mg/kg) of the drug using an     acute dosing methodology, which has been demonstrated to produce a nearly negligible side     effect profile with comparable treatment outcomes to chronic dosing. Timing of dosing will     occur 1 hour prior to behavioral intervention, in line with prior clinical studies. Study     staff, with consultation from a psychiatrist, will observe administration of DCS to     participants by caregivers via their preferred method of formula consumption (bottle, cup, or     tube) in liquid form. Participants will be evaluated during each treatment session and at     follow-up using trained observers to collect data on mealtime behaviors, including     acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data     collection is standard practice in the feeding disorders program. It is hypothesized that     participants who receive DCS as an adjunct to behavioral intervention will show greater     improvement in mealtime behaviors as reflected by these measures.   "
104073|NCT01923883|"     EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing     pancreatic and peripancreatic solid masses. The aim of this study is to compare the two     aspiration methods in EUS-FNA: negative-pressure suction with syringe vs. capillary sampling     with stylet slow-pull technique. We will evaluate the diagnostic adequacy and accuracy of the     specimens obtained by EUS-FNA with two aspiration methods.   "
104074|NCT01923870|"     -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in          overweight male subjects with hepatic impairment and in volunteers with normal hepatic          function.        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male          subjects with hepatic impairment and in volunteers with normal hepatic function.   "
104075|NCT01923857|"     -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in          overweight male subjects with various stages of renal impairment and in volunteers with          normal renal function.        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male          subjects with various stages of renal impairment and in volunteers with normal renal          function.   "
104076|NCT01923844|"     Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral     perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature     infants, which is also associated with inflammation. There are different types and doses of     surfactant preparations available. With the help of new generation monitors, changes in     peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.   "
104077|NCT01923831|"     The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on     postoperative sore throat after spinal surgery in prone position with tracheal intubation.   "
104078|NCT01923818|"     Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent     stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and     slightly increase the risk of intracerebral hemorrhage. Recently, rivaroxaban, a new oral     anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying     significantly less risk of intracranial hemorrhage.      The TRACE trial is a randomized, double-blind, multicenter, controlled clinical trial in     China. The investigators will assess the hypothesis that a 30-days rivaroxaban regimen is     superior to aspirin alone for the treatment of high-risk patients with acute nondisabling     cerebrovascular event.   "
104079|NCT01923805|"     This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss     associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's     change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to the current     standard of care will also be evaluated. The effectiveness of VG to potentially reduce pain,     and increase return to function and quality of life will be assessed through the modified     Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical Assessment Pain     Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded post-operatively.   "
104081|NCT01923779|"     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising     vaccine, currently being developed for the treatment of grass allergy.      The purpose of this optional observational follow-on study is to further evaluate     rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all     dosing visits in study TG002 approximately one year after the start of treatment.   "
104155|NCT01922804|"     The aims of the present study are to investigate the effect of vitamin K2 on bone turnover,     bone mass, bone structure, glucose metabolism, and arteriosclerosis.      Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases     that affect large groups of people in the Western world.      Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in     postmenopausal women and reduces bone turnover and increases bone mineral density; increases     insulin sensitivity and decreases indices of arterial calcification.   "
122840|NCT01678092|"     A phase 1 single center study in which omalizumab is dosed normally (according to the product     insert) in subjects with atopic dermatitis.   "
104082|NCT01923766|"     In this study, investigators are trying to see if infusion of m-CTLs will prevent or treat     cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or     infection after cord blood transplant.      Patients with blood cell cancer, other blood disease or a genetic disease may receive a cord     blood transplant (UCBT) from an unrelated donor. After receiving a cord blood transplant,     they are at risk of infections until a new immune system to fight infections grows from the     cord blood cells. In this study, investigators are trying to give special cells from the cord     blood called T cells. These cells will try to fight viruses that can cause infection.      Investigators will test to see if blood cells from donor that have been grown in a special     way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can     cause serious life-threatening infections in patients who have weak immune systems after     transplant.      T lymphocytes can kill viral cells but normally there are not enough of them to kill all the     virus infected cells after transplant. Some researcher have taken T cells from a person's     blood, grown more of them in the laboratory and then given them back to the person during a     viral infection after a bone marrow transplant. Some of these studies have shown a positive     therapeutic effect in patients receiving the CTLs (specially trained T cells) after a viral     infection in the post-transplant period. In this study we are trying to prevent or treat     viral infections by given the CTLs soon after getting the umbilical cord blood transplant.      With this study, investigators want to see if they can use a kind of white blood cell called     T cells to prevent or treat AdV, EBV and CMV infection. Investigators will grow these T cells     from the cord blood before transplant. These cells have been trained to attack     adenovirus/EBV/CMV- infected cells and are called multivirus-specific cytotoxic (killer)     T-cells or m-CTL. Investigators would plan to give patients one dose of m-CTL any time from     30 to 364 days after your transplant. They have used T cells made in this way from the blood     of donors to prevent infections in patients who are getting a bone marrow or blood stem cell     transplant but this will be the first time investigators make them from cord blood.   "
104083|NCT01923753|"     This is a double-blind randomised controlled crossover study to investigate whether high     frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in     patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This     study will test the hypothesis that the wet weight of sputum expectorated is greater     following the use of Aerosure than following the use of a sham Aerosure device.   "
104084|NCT01923740|"     To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V     Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic     heart disease caused by up to two de novo native coronary artery lesions in separate     epicardial vessels.   "
104085|NCT01923727|"     This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an     immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will     have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the     injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The     purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect     prostate cancer, and optimal time point and dose level for imaging.   "
104086|NCT01923714|"     This study aims at validating in real-life clinical practice and using the self-reported     Glaucoma Symptom Scale (GSS) questionnaire, the impact of a switch to preservative-free     dorzolamide/timolol fixed combination (DTFC) in patients using preserved topical therapy for     glaucoma.   "
104087|NCT01923701|"     The main objective of this study is to decrease the severity of symptoms and improve     psycho-social functioning in youth at high risk of developing psychosis by providing a     specialized Group-and-Family-based Cognitive Behavioral Therapy (GF-CBT).   "
104088|NCT01923688|"     The purpose of the project is to improve in-patient safety by lowering the risk of severe     hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve     communication between healthcare providers.      The procedures of the study are:        -  the hospital patient information system [Pharmacy Event System,(PES)] will generate for          healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar)        -  the real-time PES risk alert will be sent via a beeper to the patient's charge nurse        -  the charge nurse will follow the specific guidelines in the alert for assessment of the          patient's care and insulin regimen        -  the charge nurse will then notify the physician of the patient's assessment and of the          recommendation for change/no change in insulin regimen and/or clinical care        -  the alerted charge nurse and physician will complete a collaboration scale   "
104089|NCT01923675|"     1. To determine the effect of spectacles with a red blocking filter on myopia progression          in children.        2. To determine the effect of spectacles with a holographic diffuser that spreads incident          light rays over an angle of 0.5 degrees on myopia progression in children        3. To determine the combined effects of spectacles with a red blocking filter and a          diffuser that spreads incident light over an angle of 0.5 degrees on myopia progression          in children.   "
104090|NCT01923662|"     The purpose of this study is to improve the performance of neuroprosthesis for standing after     SCI by developing and testing new advanced methods that use multiple contact peripheral nerve     electrodes to slow the onset of fatigue and increase standing duration. The new advanced     methods will take advantage of the ability of multiple-contact nerve cuff electrodes to     selectively activate portions of a muscle that perform the same action. Alternating     activation to multiple muscles (or parts of the same muscle) rather than continuously     activation the entire muscle group constantly should allow them to rest and recover from     fatiguing contractions. This should allow users to remain upright for longer periods of time     to perform activities of daily living, reduce the risk of falls due to fatigue, and increase     the potential of receiving the health benefits of standing.   "
104091|NCT01923649|"     The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the     treatment of dumping syndrome.   "
104092|NCT01923636|"     The main objective of this study is to elaborate, in the neonatal period, a prognostic score     for the development of neurological and sensorineural sequelae at 1 year in neonates infected     in utero by cytomegalovirus. This score will be based on clinical, imaging and biological     evaluations.      The second objective of the study is to estimate the prevalence of this infection in France     and to describe its epidemiology through the screening of 10,000 consecutive neonates.   "
104105|NCT01923454|"     This study was to evaluate the efficacy and safety of immediate anterior chamber paracentesis     (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure (APAC).   "
104093|NCT01923623|"     This clinical, randomized, and controlled study will provide valuable scientific evidence     regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle     surgery. In particular, the investigators want to determine if the need for postoperative     opioids will be reduced and whether this will lead to shorter admission to recovery room and     fewer instances of side effects such as postoperative nausea and vomiting. In addition, the     investigators will determine whether the functional outcome is improved i.e. faster and more     successful rehabilitation. This would have profound benefits not only to the individual     patient but also to society by reducing expenses during admission, the cost of sick leave     etc.   "
104094|NCT01923610|"     24 healthy male and female volunteers who are at low risk of HIV infection and entered into     the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B     at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.      Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks.     These visits will comprise:        -  Screening        -  Trial entry and boosting immunisation        -  Early follow-up after immunisation        -  Follow-up x 2 including the final visit Participants will have blood and urine          collected, and receive 1 immunisation. They will be counselled prior to and following a          HIV test, and given health education on prevention of sexually transmitted infections          including HIV. T      The two centres which participate are:        -  Hospital Clinic, Barcelona and        -  Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and          immunogenicity of MVA-B.   "
104095|NCT01923597|"     The purpose of this study is to determine the safety and effect of green tea     (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.   "
104096|NCT01923584|"     The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's     disease.   "
104097|NCT01923571|"     Intraoperative blood glucose concentration abnormalities are associated with increased     perioperative morbidity and mortality (1-4). Severe intraoperative hyperglycemia (BGC ≥ 200     mg/dl) in patients undergoing craniotomy for urgent/emergent craniotomy after traumatic brain     injury complicates 15% of the cases and is associated with higher in-hospital mortality.     Intraoperative use of dexamethasone during craniotomy is also known to induce an increase in     blood glucose concentration.      The importance of blood glucose concentration in neurosurgical patients is witnessed by the     effects of tight blood glucose control on incidence of infections and neurological outcome .     Currently available evidence suggest that, in neurosurgical patients, perioperative BGC     values should be within the 80-180 mg/dl range .      Data on the prevalence of severe intraoperative hyper (blood glucose concentration >180     mg/dl) and hypoglycemia (blood glucose concentration <80 mg/dl) in patients undergoing     craniotomy for supra or infratentorial surgery as elective or emergency procedure are lacking     as it is not known whether in these patients intraoperative severe hyperglycemia relates to     an increased incidence of postoperative infections is unknown.      Aim of this prospective observational study -in patients undergoing craniotomy for supra or     infratentorial surgery as elective or emergency procedure- was to test the hypothesis that     severe intraoperative hyperglycemia (blood glucose concentration ≥180mg/dl) is associated     with an increased incidence of infections within the first postoperative week (pneumonia,     sepsis, urinary and wound and cerebral infections). We also recorded the prevalence of severe     intraoperative hyper and hypoglycemia (blood glucose concentration<80 mg/dl) in recruited     patients.   "
104098|NCT01923558|"     To evaluate and compare the relative bioavailability and therefore the bioequivalence of two     different formulations of donepezil after a single oral dose administration under fasting     conditions.   "
104099|NCT01923545|"     This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety     compared to daily G-CSF in chemotherapy-induced neutropenia.   "
104100|NCT01923519|"     The respiratory epithelium plays a leading role in the development of allergic respiratory     disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the     ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have     reached concomitant ENT: the concept of one airway, one disease. Access to this material of     epithelial study in the different phenotypes of the disease appears to be crucial. Nasal and     bronchial epithelial tissues reveal essential differences in particular related to their     environment (remodeling less intense and a lower sensitivity to the virus in the nose), but     they nevertheless share many common cellular characteristics.   "
104101|NCT01923506|"     This phase I trial studies the side effects and best dose of stereotactic body radiation     therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body     radiation therapy may be able to send x-rays directly to the tumor and cause less damage to     normal tissue.   "
104102|NCT01923493|"     The aim is to evaluate whether tuina is more effective and cost-effective than no     intervention waiting list to reduce neck pain measured on a visual analogue scale in patients     suffering from chronic neck pain.   "
104103|NCT01923480|"     The purpose of this study is to determine the best rate of infusion of amino acids (15%     CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II     to IVB head and neck cancer.   "
104104|NCT01923467|"     This project is designed to test the effects of affirmation and positive/negative imagery on     individuals' thoughts about quitting smoking and willingness to join a stop smoking program.     Previous studies have noted that viewing negative images elicits a stronger emotional     response, and many stop-smoking campaigns have used such images to push people to quit     smoking. However, research also shows that people are generally resistant to health messages.     Using affirmation can help to lessen that resistance.      In this study, we use a 2x3 design to study the individual effects of negative imagery and     affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit     smoking program, and program participation and outcomes. We hope to find out whether there is     an additive effect of the negative imagery and affirmation on the outcomes listed above. Our     specific aims are:      Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking     program.      Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of     the stop smoking program offer.      Aim 3: Determine whether there is an interaction between image type and affirmation in     people's willingness to join a stop smoking program.   "
104156|NCT01922791|"     A randomized double-blind placebo controlled intervention study with pregnant obese women     (n=440) will be conducted. The intervention will involve consumption of fish oil and/or     probiotic capsules from early pregnancy until 6 months after delivery.      The aim of the study is firstly to investigate the effects of the supplements on the risk of     gestational diabetes mellitus and obesity in the women and secondly to modify the risk     markers of allergy and obesity in children of the women. Also the underlying metabolic     mechanisms will be investigated.   "
104548|NCT01917695|"     The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo     irradiation in carcinoma cervix and to compare its results with the concurrent chemo     irradiation in terms of overall survival, disease free survival and quality of life.   "
104106|NCT01923441|"     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which     are temporal reflections of the neural mass electrical activity of cells in specific regions     of the brain that occur in response to stimuli, may offer such a method, as they provide both     a noninvasive and portable measure of brain function. The ERPs provide excellent temporal     information, but spatial resolution for ERPs has traditionally been limited. However, by     using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is     improved significantly. The paradigm for the current study will combine neurophysiological     knowledge with mathematical signal processing and pattern recognition methods (BNA™) to     temporally and spatially map brain function, connectivity and synchronization.      The proposed study will provide additional evidence for the utility and contribution of the     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain     functional connectivity associated with concussion) in concussion management.   "
104107|NCT01923428|"     This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate     the safety and efficacy of three dose levels of AZD1722 in subjects with constipation     predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as     determined during a two-week screening period. Subjects who qualify and are randomized into     the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive     weeks. At the end of this treatment period, subjects will be followed for an additional 4     weeks.   "
104108|NCT01923415|"     The purpose of this study is to characterize the clinical and molecular profiles of patients     with cutaneous lupus.   "
104109|NCT01923402|"     This study was conducted to develop biomarkers of tobacco effect that would indicate     potential harm related to tobacco consumption. To gain a better understanding of chronic     effects of tobacco consumption, this cross-sectional clinical study enrolled generally     healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco products     (NTC).   "
104110|NCT01923389|"     This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple doses of PF-05231023.   "
104111|NCT01923376|"     The purpose of this study is to evaluate whether the use of polyethylene glycol is superior     and more safe in treating hepatic encephalopathy compared to lactulose and also to determine     if treatment with polyethylene glycol will reduce the duration of hospital stay.   "
104112|NCT01923363|"     Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated     as a risk factor for hospital-acquired infections and increased occurrence of death in     critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for     critically ill patients with an infection, however, limited information exists for dosing     this drug in obese patients. In these limited reports, standard doses of     piperacillin/tazobactam given to the small number of obese patients resulted in lower blood     concentrations, which could lead to inadequate killing of bacteria. The purpose of this study     is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to     higher dosing regimens in obese patients. This study will also include information on the     safety and tolerability of the higher dose regimens. The study investigators believe that the     higher dosing regimen will produce adequate blood levels in obese patients and will not add     any more risk of harm to obese patients receiving this higher dose.   "
104113|NCT01923350|"     The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the     effectiveness of interventions that potentially increase the adoption of Diabetes Prevention     Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).      The study was conducted as an integrated trial with two separate arms: one to facilitate     weight reduction and the other to increase diabetes testing.      There were two hypotheses:        1. Women in the testing intervention will be more likely to have received a diabetes test          within the 6 months post-intervention than women in the control group.        2. Women in the weight reduction intervention will have lost more weight at the 6-month and          9-month follow-up than women in the control group.      The primary study aim was to determine the efficacy of a system of interactive     technology-based supports to prompt women with a history of gestational diabetes to take     steps to prevent diabetes. The secondary aims were focused on women's engagement:        -  To evaluate the impact of the weight reduction intervention in terms of participant          engagement with the interactive technology-based supports.        -  To evaluate changes in the women's perception of their personal diabetes risk following          after exposure to information about diabetes risk following a pregnancy with GDM.        -  To identify the determinants and motivators of and barriers to diabetes testing in the          6- to 12-week postpartum period and thereafter, using the Health Belief model to guide          the study.      There was an additional secondary aim involving metformin:        -  To evaluate the impact of the diabetes risk reduction intervention in terms of women          seeking out their physician's advice on metformin treatment and receiving a metformin          prescription, if appropriate.   "
104114|NCT01923337|"     This phase I trial studies the side effects and best dose of alisertib when given together     with irinotecan hydrochloride in treating patients with advanced solid tumors or colorectal     cancer. Irinotecan hydrochloride and alisertib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
104115|NCT01923324|"     The purpose of this study is to investigate whether pain control for patients with chronic     pain is improved by the availability of structured telephone consultations between the     patients' family physicians and pain physicians, compared to pain control for patients     receiving usual care.   "
104116|NCT01923311|"     This study will evaluate the steady-state pharmacokinetics (PK) and confirm the dose of     ritonavir (RTV)-boosted elvitegravir (EVG/r). This study will also evaluate the safety,     tolerability, and antiviral activity of elvitegravir (EVG) administered with a background     regimen containing a ritonavir-boosted protease inhibitor (PI/r) in HIV-1 infected,     antiretroviral (ARV) treatment-experienced pediatric participants.      The study consists of 2 parts: Part A and Part B. Part A will enroll participants with     suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current ARV regimen (HIV-1 RNA >     1,000 copies/mL) to evaluate the steady state PK and confirm the dose of EVG. Part B will     enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to     evaluate the safety, tolerability, and antiviral activity of EVG.   "
104117|NCT01923298|"     Estrogen receptor positive breast cancer is the most common type of breast cancer and     anti-estrogen therapy has been shown to be very effective in preventing recurrence. Side     effects of anti-estrogens are due to estrogen deprivation and include hot flashes, mood     changes and vaginal dryness/pain. Vaginal symptoms including pain, dryness, itching, bleeding     after intercourse and frequent urinary tract infections have been reported to cause     significant morbidity in postmenopausal women and higher in breast cancer survivors on     anti-estrogen therapy. Treatment options include vaginal lubricants, Replens etc but     unfortunately many women continue to have persistent symptoms. Local estrogen has been shown     to be effective in post menopausal women (Estring or Vagifem) for their vaginal symptoms.     There is a concern of using this in women with breast cancer given it may increase their     blood estrogen levels. Studies done so far show have shown controversial results but majority     of them report that blood estrogen levels do not change significantly. The major drawback of     the studies was the sample size and inadequate accrual. The most recent trial reported showed     no significant change in blood estrogen levels in women with breast cancer treated with     aromatase inhibitors (anti-estrogen therapy) and were on vagifem for their vaginal symptoms.     The authors reported results in 26 patients and reported no significant change in blood     estrogen level. We propose to study the change in blood estrogen level when postmenopausal     women with breast cancer who are currently on aromatase inhibitors are treated with Estring     for their vaginal symptoms.   "
104118|NCT01923285|"     The purpose of this study is to evaluate the safety and effectiveness of the AXIUM     Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with     Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).   "
104119|NCT01923272|"     The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled     pilot study is to study feasibility and collect additional preliminary clinical data related     to the safety and clinical benefits of non-invasive vagal nerve stimulation with the     AlphaCore device for the treatment and prevention of exercise-induced bronchoconstriction,     and to support the development and approval of a larger pivotal study.      The objectives of this study are (1) to gather preliminary safety and efficacy data of the     AlphaCore device for the treatment of EIB (Treatment Visit 1) and prevention of EIB     (Treatment Visit 2), (2) to validate the sham device (blinding effects, placebo effect) as an     effective control for use in future clinical studies, and (3) to support the development and     approval of a pivotal study, confirm data collection methods and endpoint definitions, and     confirm appropriateness of the subject follow up plan.   "
104120|NCT01923259|"     To evaluate and compare the relative bioavailability and therefore the bioequivalence of two     different formulations of donepezil after a single oral dose administration under fed     conditions.   "
104121|NCT01923246|"     The primary aim of the present study is to study the effect of a brief automated alcohol     intervention in University students, and if there is a difference in effect between automated     brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to     study if there is difference in effect between single and repeated interventions.   "
104122|NCT01923233|"     This study is an individualized anti-cancer vaccine protocol where the vaccination occurs     inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a     process called Radiofrequency Ablation or RFA. RFA causes the tumor to release its internal     contents to the surrounding environment, such contents include tumor-specific antigens.     Immune cells respond to the tissue damage and take-up these tumor antigens. The injection of     the experimental cell drug, AlloStim(TM) into the lesion is designed to cause the responding     cells to signal the immune system of the danger of the tumor, creating tumor-specific     immunity.   "
104123|NCT01923220|"     This is a single-center, open-label, randomized, prospective study evaluating the safety and     efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment     fields vs. standard of care (SoC), Aloe Vera treatment   "
104124|NCT01923207|"     The purpose of this study is to assess the safety and tolerability of the study drug     (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to     receive DX-2930 or placebo.   "
104125|NCT01923194|"     Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to     Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females   "
104126|NCT01923181|"     This trial is conducted globally. The aim of the trial is to examine the dose range,     escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.   "
104127|NCT01923168|"     The purpose of the study is to determine whether treatment with a PI3K inhibitor plus     letrozole leads to an increase in pathologic clinical response and Objective Response Rate     compared to treatment with placebo plus letrozole in patients with Breast cancer   "
104128|NCT01923155|"     There is no theoretical or practical reason why non-medical personnel such as nurses could     not be trained to perform diagnostic colonoscopy with comparable proficiency as medical     endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past     15 years as a valuable resource to cope with the increasing demand for endoscopic service, in     particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong     Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy     safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists     have a comparable proficiency in performing colonoscopy procedures as their medical     counterparts.   "
104129|NCT01923142|"     The purpose of this study is to evaluate the hypothesis that, in patients with stable     vitiligo unresponsive to conventional treatments including traditional phototherapy and/or     topical steroids, the application of a non-cultured autologous hair follicle     outer-root-sheath melanocytes suspension in the area affected by the disease followed by     targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To     assess the effect of the proposed treatment, a within-subject controlled study involving     selected symmetric lesion areas localized to the back of the hands will be conducted.   "
104138|NCT01923025|"     This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy     Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission     tomography (PET).   "
104139|NCT01923012|"     Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid     stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the     calcified component.   "
104130|NCT01923129|"     There is no general agreement about the optimal duration of postoperative urinary drainage,     with relevant literature reporting durations ranging from 1 to 10 days. The available     research supporting the routine use of prolonged catheterization is limited and studies     investigating early removal following infraperitoneal colorectal surgery have largely been     underpowered to form valid practice conclusions. The aim of the investigators study is to     determine whether a postoperative colorectal patient can safely have an indwelling catheter     removed on postoperative day one (24 hours following surgery) with the addition of a study     medication (prazosin), without a statistically significant difference in the incidence of     urinary retention compared to the standard, accepted approach of delayed removal (72 hours     postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below     the peritoneal reflection for both benign and malignant conditions will be randomized into     two groups: group one will have the catheter removed on postoperative day 3 (72 hours     postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior     to catheter removal and will have the urinary catheter removed on postoperative day 1 (24     hours postoperatively).   "
104131|NCT01923116|"     The objective of the study is to assess, in a phase 1/2 study, the safety and efficacy of     this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and     HPV16-induced intra-anal high-grade AIN (grade 2-3) that failed on, or recurred after     previous treatment.   "
104132|NCT01923103|"     Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and     fingers, which may lead to extension deficits of the fingers. The disease can be very     disabling in moderate and severe cases, whereby performing normal daily activities can become     very problematic. The aetiology and pathogenesis are not completely understood. There is a     genetic disposition and it is influenced by environmental factors. The disease is especially     prevalent in white males of Northern European descent above 50 years of age. There is paucity     of knowledge about the natural progression of the disease. Several studies have been     conducted on progression of disease and from these studies it becomes obvious that the     disease is progressive over several years. However, in most studies only one moment of     follow-up has taken place, so the course of the progression over time is unknown.      The aim of this study is to enhance our knowledge on the natural disease progression of DD at     different stages.   "
104133|NCT01923090|"     The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is     important in controlling how the body handles sugar and fat. The investigators believe that     5αR is a crucial step in regulating these actions as well as controlling how insulin works in     the body but regulating the amount of steroid hormones including cortisol and testosterone in     the body. In previous clinical studies, the investigators have shown that the activity of 5αR     increases as you gain weight and decreases with weight loss. In addition, work that the     investigators have performed in the laboratory has shown that if you increase 5αR levels in     liver cell grown in the laboratory, the amount of fat that they contain increases. The     investigators would therefore like to demonstrate the effect of inhibition 5αR on the     regulation of insulin, glucose and fat in the body.   "
104134|NCT01923077|"     Objective: Statins have been shown to have beneficial pleiotropic effects besides being lipid     lowering. The investigators hypothesized that early and intensive statin treatment was     associated with improved left ventricular (LV) function and with a stabilization of the     coronary atherosclerotic plaques in patients with acute myocardial infarction (AMI) Method:     In a prospective randomized blinded endpoint trial patients with ST segment elevation or non     ST segment elevation AMI were randomized to either intensive statin-therapy (loading dose     rosuvastatin 80 mg immediately after randomization followed by 40 mg daily) or usual statin     therapy (simvastatin 40 mg daily). Patients were followed 12 month and the investigators     performed echocardiography at randomization, after 30 days and after 12 month. The     investigators used 2D Speckle Tracking for the assessment of LV-function. Coronary plaque     assessment was done with Cardiac-CT (MSCT) at baseline and after 12 month.      Primary outcome for this study was assessment of LV function with global and regional     myocardial strain. Secondary outcomes can be divided in 4 groups:        1. Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume,          atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate.        2. Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM,          E-selection and Nitrate/Nitrite ratio.        3. Coronary plaque assessment by MSCT: Plaque volume and plaque stability.        4. Long term follow-up: Mortality and cardiovascular events   "
104135|NCT01923064|"     The purpose of this randomized study to compare effect of endoscopic injection of a mixture     of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.   "
104136|NCT01923051|"     The chronic obstructive pulmonary disease (COPD) is the occurrence of chronic bronchitis or     emphysema, a pair of commonly co-existing diseases of the lungs in which the airways narrow     over time. This limits airflow to and from the lungs, causing shortness of breath (dyspnoea).     In clinical practice, COPD is defined by its characteristic airflow limitation on lung     function tests. In contrast to asthma, this limitation is poorly reversible and usually gets     increasingly worse over time.      The COPD registry is a non-interventional multicentre observational prospective database     focusing on the collection and analysis of data on real mortality and morbidity in COPD     population of the Czech Republic population of COPD patients. Monitoring is done at the     occasion of regular check-ups, followed by retrospective search of data in the documentation,     and a record into the registry.      The aim of Czech National Research Database of Chronic Obstructive Pulmonary Disease is to     establish the clinical course of severe forms of COPD, establish the cause for deterioration     of clinical status of our patients and describe the progression of COPD to death.      The registry fulfils general objectives of health registries such as monitoring of causes,     development, treatment and consequences of a severe disorder, including economic and social     impacts. Statistical and scientific analyses of the registry data are focused, in particular,     on the assessment of health determiners of the selected patient cohort with the aim to     improve health status of the patients.   "
104137|NCT01923038|"     Atelectasis involving declive areas often occurs during general anesthesia and may persist     postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg     position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress     Index (SI), during constant flow inflation can lead ventilator setting during general     anesthesia.   "
104141|NCT01922986|"     When a certain area of the brain is injured, like in stroke, several events occur. One side     of the body may become weak. This weakness is called hemiparesis and it may create difficulty     in performing tasks like writing, eating, and walking. The weakness results from two sources:        1. death of some brain cells in the affected side (hemisphere) of the brain        2. exaggerated inhibitory signals from the unaffected hemisphere acting on surviving          neurons in the affected hemisphere.      Investigators cannot change neurons that have died but they may be able to change the     exaggerated inhibition that impairs the surviving neurons in the affected hemisphere.The     purpose of this study is to try to decrease the exaggerated inhibition coming from the     unaffected hemisphere, which suppresses the affected hemisphere, with transcranial magnetic     stimulation (TMS). Investigators hypothesize that, from admission to discharge, active rTMS     combined with conventional therapy will produce greater functional gains in the paretic hand     compared to sham rTMS combined with conventional therapy, as measured by standard tests.   "
104142|NCT01922973|"     The overall objective of this study is to determine the extent to which circulating ghrelin     levels (total and bioactive ghrelin) are regulated by nutritional state and age.   "
104143|NCT01922960|"     Predict the development of multiple organ failure in patients with trauma and severe burns.   "
104144|NCT01922947|"     The purpose of this research is to test the feasibility and efficacy of a brief (one session)     preventative intervention using motivational interviewing integrated with social network     counseling for substance use among adolescent patients in a primary care setting. One hundred     participants will be randomly assigned to either motivational interviewing integrated with     social network counseling or attention control conditions. The motivational interviewing     integrated with social network counseling condition is expected to show improvement when     compared to the attention control condition.   "
104145|NCT01922934|"     Obesity is common, causing many medical problems in adults (e.g., diabetes, hypertension,     high cholesterol, sleep apnea, heart attack, strokes). A range of treatments have shown to be     effective for treating obesity. Treatments include lifestyle modification, meal replacements,     and weight loss medication. Most primary care settings do not provide much obesity treatment,     though, as primary care providers (PCPs) are not well trained and because reimbursement for     treatments is not consistent.      Hypothesis: If PCPs have training in weight management and if most costs of treatment are     reimbursed, we surmise that a toolbox of treatments can produce a clinically important     weight loss amount in a large group of patients.      Design: We propose to establish a registry of obese patients with at least one common medical     condition related to their weight. From the registry, we will randomly select 350 people to     be offered treatments to assist with weight loss. The remainder of the registry's patients     can still receive obesity treatment but will not be reimbursed. We will conduct the study at     Denver Health, a large public health care system that treats a low income, ethnically diverse     population. All 350 patients will be offered some self-monitoring tools for weight management     and the chance to do a computer assessment to select the right treatment for weight loss.     Patients who complete this and record their food intake and physical activity for 1 week will     be offered a Level 2 treatment for weight loss. Level 2 treatments include: a voucher for a     commercial weight loss program; intensive group weight loss counseling; meal replacements;     gym membership; or weight loss medication. Patients will choose which treatment they want,     with the approval of their PCP. Researchers at Denver Health will help with the computer     assessment and dispensing the treatments. We are interested in what percentage of patients     lose at least 5% of their starting weight. We will also explore changes in glucose, blood     pressure, and cholesterol, and we will look at how much this intervention costs and whether     patients need less medication for their weight-related conditions at the end of the study.      Impact: If the study is successful, we plan to take the results to the leaders at Denver     Health to see if they will make obesity treatment more broadly available for all patients     there.   "
104146|NCT01922921|"     This randomized phase I/II trial studies the side effects of vaccine therapy with or without     polysaccharide-K and to see how well it works in treating patients with stage IV human     epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving     HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain (ICD)     peptide may help the body build an effective immune response to kill tumor cells that express     HER2. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells     from growing. It is not yet known whether vaccine therapy works better when given with or     without polysaccharide-K in treating breast cancer.   "
104147|NCT01922908|"     The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible     and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose     when given between 3-10 days after an ischemic stroke.   "
104148|NCT01922895|"     This study is being done to find out whether a diet supplemented with a probiotic nutrient     can improve alcoholic hepatitis and gut complications compared to routine standard care.   "
104149|NCT01922882|"     The purpose of this trial is to test whether, compared to the normal Standard of Care at     primary health care clinics, a home-based counseling intervention ( the 'Amagugu' Counseling     Intervention), will increase the number of HIV-infected mothers who are able to disclose     their own HIV status to their primary school-aged children. The investigators also wish to     examine whether the intervention improves the quality of the maternal-child relationship,     emotional and well-being of the child and social support.   "
104150|NCT01922869|"     The era of general dietary recommendations for the whole population may be coming to an end,     as it is becoming apparent that we are all unique and do not respond in the same way to the     same foods. Within a decade it is believed that doctors will be able to take profiles of     their patients, identify specific diseases for which they are at risk and create personalised     nutrition plans accordingly. At the University of East Anglia, UK the investigators are     interested in particular food compounds known as flavonoids which can be found in foods such     as chocolate, orange juice and blackberries (COB). The study will determine if factors such     as age, gender, genetics and the bacteria present in our guts contribute to variability     between individuals in their absorption, metabolism and excretion of flavonoids.   "
104151|NCT01922856|"     The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E.     coli (ETEC)-caused diarrhea.   "
104152|NCT01922843|"     The goal of this study is to test a new vitamin D compound for its ability to reduce     parathyroid hormone levels in patients who are on hemodialysis.   "
104153|NCT01922830|"     This study is a randomized clinical trial with 6 months probiotic supplement vs. placebo     treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy     surgery. Measurements will be conducted at: baseline, M3 (3 months after treatment     initiation), M6 and M12 and will include: abdominal US, Fibroscan, biochemical tests,     anthropometric measurements, glucose breath test for bacterial overgrowth, fecal samples and     questionnaires for demographic details, quality of life, food intake, food tolerance and     habitual physical activity. 20 subjects will undergo an additional liver-MRI test at baseline     and M6.   "
104154|NCT01922817|"     Ninety years ago the discovery of insulin and its development as a drug revolutionized the     management of type 1 diabetes, which until that point had almost inevitably proven fatal.     However, very rapidly it was recognized that like all wonder drugs there were problems with     insulin. Elliot Joslin, one of the pioneers of diabetes therapy described insulin as …a     potent preparation alike for evil and for good(1922). There are two major reasons for this.     Firstly, in non-diabetic individuals insulin produced by the pancreas acts directly on the     liver, the major organ for regulating blood glucose levels. In contrast, people with type 1     diabetes inject insulin under the skin, and this is then absorbed into the circulation and     much of it is degraded (~50%) before it gets to the liver. This means that in order to act     effectively in the liver a type 1 diabetic needs to inject at least double the amount of     insulin. Many studies have now shown that high insulin levels lead to weight gain,     accelerated blood vessel disease (atherosclerosis) and a higher risk of suffering low blood     glucose (hypoglycaemia). A second major problem is that individuals with type 1 show high     levels of the hormone, glucagon. Glucagon is also produced in the pancreas and is normally     regulated by pancreatic insulin, so the loss of this effect in people with type 1 diabetes     means they run high glucagon levels. This has been shown to increase blood glucose,     particularly after a meal. It is because of this that the diabetes community has called for     novel therapies that can reduce high insulin levels and high glucagon levels. A new class of     drugs called dipeptidylpeptidase IV inhibitors (DPPIVi) are currently used to treat people     with type 2 diabetes. DPPIV inhibition increases endogenous levels of glucagon like peptide-1     (GLP-1). These drugs have a number of actions but the most relevant to this application is     that they directly suppress glucagon, induce satiety (i.e. reduce hunger and leads to a     reduction in body weight) and indirectly reduce the need for high dose insulin injections.     This makes them an ideal candidate drug as an insulin sparing or adjunct therapy in type 1     diabetes, but there is very limited data to date for this use. We would like to run a small,     pilot, randomised, cross over trial that investigates the potential for DPPIVi therapy to     reduce insulin requirements in type 1 diabetes. We would like to investigate to see if this     drug reduces daily insulin doses, leads to weight reduction, reduces blood glucose     fluctuation and improves glucose control. Through reduction of blood glucose variability, we     want to investigate, whether it has the capability of improving the magnitude of epinephrine     responses at 2.5mmol/L by performing a hyperinsulinaemic, hypoglycaemia clamp study after     each arm. A successful outcome would then lead to an application for funds for a larger,     multicentre intervention study. The benefits of this therapeutic advance are clear and this     has the potential to make a dramatic improvement to the lives of people with type 1 diabetes     in our community.   "
104157|NCT01922778|"     The purpose of this study is to develop an endometrial biopsy screening program for     endometrial cancer and its precursor lesions in overweight and obese women.      There is a BMI threshold at and above which optimal screening parameters exist for     identifying endometrial cancer and its precursor lesions in overweight and/or obese women.     Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in     overweight and/or obese women offers substantial health benefits.   "
104158|NCT01922765|"     If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin,     rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with     amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole     for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant),     then the eradication rate of concomitant group will be the highest.   "
104159|NCT01922752|"     The primary objective is to determine the maximum tolerated dose (MTD), safety, and     tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic     solid tumors.   "
104160|NCT01922739|"     This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety     of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe     chronic low back pain who require continuous opioid treatment for an extended period of time.      To be eligible for Study 3104, patients were required to have completed the entire double     blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets)     through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study     3104.   "
104161|NCT01922726|"     The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial     Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY     200 DR pacemaker.   "
104162|NCT01922713|"     The purpose of the study is to determine whether daily consumption of beta-carotene     biofortified maize will increase breast milk retinol concentration in lactating Zambian     women.   "
104163|NCT01922700|"     Pepper sprays and pepper gas grenades are used by riot police at various places in the world     for crowd control. Data about the acute effects based on human studies is extremely scarce.     Kashmir valley in the northern Indian state of Jammu & Kashmir has witnessed political     turmoil for the past 22 years and incidents of stone pelting are common wherein groups of     youth indulge in stone pelting at the security personnel. While there have been previous     episodes of fatalities associated with incidents of firing by the security personnel; non     lethal methods are adopted routinely now. These include lathis, water cannons, tear gas and     more recently the pepper gas grenades. The pepper grenades explode in the area and the     adverse effects are perceived by the population in the area too who are even sitting in their     homes. The study proposes to observe the health effects of the pepper gas exposure in     non-combatant civilians.   "
104164|NCT01922687|"     The primary objective of this study is to test the hypothesis that amlodipine plus     atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has     a stronger effect in protection of arterial structure and function.   "
104165|NCT01922674|"     Purpose: To determine if observation (watchful waiting is a safe alternative to routine     repair of asymptomatic inguinal hernias in adult males.      Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at     diagnosis to prevent the life threatening complications of bowel obstruction or incarceration     with strangulation and that operation becomes more difficult the longer a hernia is left     un-repaired.   "
104166|NCT01922661|"     The primary objective of the study is to assess the safety and tolerability of single     ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult     subjects.   "
104167|NCT01922648|"     Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single     most important cause of severe respiratory illness in infants and young children, and severe     RSV infection early in life is associated with an increased risk of later developing asthma.     RSV also causes severe disease in elderly and immune-compromised adults, and the amount of     RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in     the secretions of the upper respiratory tract of infected individuals and by contact with     contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and     neonatal wards, are not uncommon.      Infection by RSV does not develop a natural long-lasting protection against re-infection     (like, for example, measles does). In the USA nearly all children by 24 months of age have     been infected at least once with RSV, and about half will have experienced two infections.     There is no effective anti-viral drug to treat an infection and the only way of managing     cases of severe infection is through supporting organs, such as the lungs, to withstand and     recover from the illness.      There remains a real need to develop an effective vaccine to prevent severe infections caused     by RSV. A better understanding of the way the immune system responds to RSV in children would     aid the development of such a vaccine.      The purpose of this study is to increase our understanding of how the immune system responds     to RSV. Only limited data is available on some important components of the immune response     and this study is designed to measure these in more detail. This is done using a single blood     sample.      A total of 35 children are anticipated to be recruited to this study, at ages when we expect     to see differences in the immune response to RSV;        -  5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV        -  20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one          single RSV season in the winter of 2011/12        -  10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over          several winter seasons   "
104188|NCT01922375|"     This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male     patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.      The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect     in improvement of voiding and storage difficulty.      Design:      Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design   "
104168|NCT01922635|"     The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20     years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the     prognosis for survival, alter the body image imposing a visible deformity and of which the     treatment which aims at reducing and at stabilizing the physical deformation is binding and     expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the     everyday life of the child and on the family environment. This question is all the more     important, that all the studies show that the success of the treatment bases on the     compliance in the concentration and in the care of hygiene. The parameters of the success of     these treatments at the child are not known.   "
104344|NCT01920347|"     The trial will evaluate the use of the Neurological Pupil index NPi, measured with the     digital pupillometer (NeurOptics) compared to clinical examination for better reliability.     The investigators hypothesize that digital evaluation will offer a higher sensitivity/     specificity compared to clinical examination.   "
104169|NCT01922622|"     Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients     with multiple comorbidities. Anaesthetic management of this patient group is extremely     challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered     via a spinal catheter leads to better cardiovascular stability.The minimum dose of local     anaesthetic with intrathecal fentanyl was not established yet.We propose to study and     determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20 mcg     of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for the     operative fixation of FNF.We will use a previously well established Dixon and Massey     up-and-down method to calculate initial MLAD in this prospective, observational trial.      Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of     fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on     the side of FNF.      Outcomes      Primary outcome:        1. Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up          to T10 on the side of FNF.           Secondary outcomes:        2. Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative          fixation of fractured neck of femur.        3. The effect on haemodynamic variables (blood pressure, heart rate).        4. Incidence of side effects        5. The length of postoperative analgesia (the time from the last dose of local anaesthetic          administered intrathecally to VAS>3).        6. The time to first rescue analgesic requirement      Study Design Prospective, observational trial.      Study Size Based on the previously well established Dixon and Massey up-and-down     method(10), we will recruit patients until a successful spinal block has been achieved in     six consecutive patients who received a specific dose. This is the requirement to calculate     the initial MLAD.   "
104170|NCT01922609|"     The aim of this observational pilot study is to determine whether intolerance of carotid     occlusion during carotid artery stenting can be predicted with preprocedural transcranial     Doppler evaluation.   "
104171|NCT01922596|"     The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a     Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe     pain (VAS pain score > 60) after Total Knee Arthroplasty (TKA.   "
104172|NCT01922583|"     This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR     T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged     NSCLC.   "
104173|NCT01922570|"     Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with     a functioning digestive tract. Nevertheless, EN alone is often associated with digestive     intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or discontinued,     resulting in insufficient energy and protein intakes and increase complications rate in ICU     patients. Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or     on Parenteral nutrition (PN). This difference is likely to be related to the level of EN     administration needed to optimize the coverage of nutritional needs at a time when the gut     has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on     global cost, because the management of patients with diarrhoea is time-consuming for the     nurses and all medical staff, it requires investigations (water and electrolytes balances,     microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc).     However, the economic impact of diarrhoea related to EN or the combination of EN and PN has     never been evaluated in the ICU setting.   "
104174|NCT01922557|"     To study the association of the thoracic fluid content and acute lung injury during liver     transplantation.   "
104175|NCT01922544|"     In patients undergoing CRT device implantation a lead positioning in the coronary sinus is     required. Even this part of the surgical procedure is challenging. In this study we compared     retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.   "
104176|NCT01922531|"     To measure Axonal Injury in children with mild traumatic brain injury enrolled in an     Emergency Department using Diffusion Tensor Imaging, a type of MRI and biomarkers.   "
104177|NCT01922518|"     Typically pacemaker electrode has been attached to the right ventricular apex. This method     lead to Non-physiological Ventricular contraction. It has been reported to cause by     ventricular dysfunction. In conclusion, this study demonstrate that impact of right     ventricular pacing determined by electrocardiography was planned.   "
104178|NCT01922505|"     The purpose of this study is to investigate the trend of eradication rates of first-line     triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect     the eradication in Korean.   "
104179|NCT01922492|"     -  Effects of autologous islet transplantation were compared to those of oral anti-diabetic          drugs after distal pancreatectomy.        -  The primary interest is a insulin-secretory function after the surgery in two          intervention groups.   "
104180|NCT01922479|"     Heart failure (HF) is a major global public health issue which also affects Asia. Data from     the National Registry of Disease in Singapore shows a 9.4% rise in HF admissions in public     hospitals from 2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a common     problem occurring in HF, ranging from 14% to 56% in outpatient registries and clinical     trials. Anaemia exacerbates the basic symptoms of HF of dyspnea and exercise intolerance,     thereby reducing quality of life (QoL). However, recent approaches aimed at improving and     normalizing Haemoglobin have been unsuccessful.Novel approaches are required to address this     problem. Iron deficiency (ID) is a well-understood cause of anaemia. ID without overt anaemia     may be present in HF patients. A recent study by Jankowska et al published in 2010 of 546 HF     patients showed a 37% prevalence of ID, regardless of Haemoglobin level. This was associated     with worse outcomes including impaired exercise capacity. The presence of ID indicates a     higher likelihood of deteriorating and dying early. A landmark study published in the New     England Journal of Medicine (The Ferinject Assessment in Patients with Iron Deficiency and     Chronic Heart Failure (FAIR-HF) study) showed that HF patients who were treated with IV iron     in the form of Ferric Carboxymaltose (FCM) had better outcomes, including improved exercise     capacity, overall function, and quality of life.      There is a lack of contemporary data on ID in HF patients in Asia, including data on     treatment with this novel IV iron FCM.      Hypothesis We hypothesise that treating ID in HF patients in Asia using FCM will improve     outcomes including exercise capacity, quality of life, overall functional status, and the     need to be hospitalised for complications arising from HF.   "
104194|NCT01922297|"     This study will determine the clinical effectiveness, moderators and mechanisms of change,     and economic impact of an integrative, family-based intervention that concurrently targets     change in HIV/Sexually Transmitted Disease (STD)-associated risk behaviors, drug abuse,     delinquency, arrest and mental health outcomes for juvenile offenders committed to a juvenile     justice day treatment program.   "
104345|NCT01920334|"     A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU     patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug     (zolpidem controlled release).      The study hypothesis is that sleeping better can improve the heart recovery in patients with     a diagnosis of acute coronary syndrome.   "
104195|NCT01922284|"     UKHVC Spoke 003 is a randomised Phase I, two centre study which will explore the impact of     shortening a vaccination regimen using deoxyribonucleic acid (DNA) (CN54ENV and ZM96GPN),     Modified Vaccinia Ankara - C (MVA-C) and CN54rgp140 adjuvanted with glucopyranosyl lipid A     adjuvant - aqueous form (GLA-AF). The study population will be 40 healthy male and female     volunteers 18 to 45 years old who are at low risk of HIV infection are to be recruited.      Study participants will be immunised with trial immunogens:        -  8mg DNA: one plasmid encoding a gag-pol-nef polypeptide derived from the 96ZM651-8 clone          and one plasmid encoding gp140 env derived from clade C 97CN54        -  1.108 TCID50 MVA-C (nominal titre) expressing the gag-pol-nef and gp120 env proteins          derived from clade-C 97CN54        -  100ug CN54rgp140, a trimeric recombinant envelope protein derived from clade C 97CN54        -  5ug GLA-AF, an aqueous glucopyranosyl lipid A adjuvant      All immunisations will be administered by the intramuscular route (IM). CN54gp140 and GLA     will be mixed together before administration, and immunogens will be delivered in combination     regimens   "
104196|NCT01922271|"     The purpose of this study is to further figure out differences of glycopyrronium bromide     compared to tiotropium in early bronchodilation measured by a comprehensive assessment of     lung function that includes hyperinflation and specific airway resistance in patients with     moderate to severe COPD.   "
104197|NCT01922258|"     To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with     agitation associated with dementia of the Alzheimer's type   "
104198|NCT01922245|"     This project will investigate the use of noninvasive brain stimulation in the form of tDCS     (transcranial direct current stimulation) in conjunction with speech-language therapy, for     the improvement of language production in stroke survivors with aphasia. The hypothesis is     that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to     speech therapy alone.   "
104199|NCT01922232|"     This is a prospective study of pretreatment DW-MRI to identify potential imaging biomarkers     predictive of response to neoadjuvant chemotherapy in patients with muscle-invasive bladder     cancer. Target enrollment of this study is 40 patients. Patients will first undergo baseline     DW-MRI of the Abdomen and Pelvis prior to beginning standard treatment with neoadjuvant     cisplatin-based chemotherapy after which DW-MRI will be repeated to assess for response or     progression. Patients who remain eligible for surgery will proceed to standard radical     cystectomy with pelvic lymph node dissection. DW-MRI metrics including apparent diffusion     coefficient (ADC) values will be correlated to pathologic response rate in the radical     cystectomy specimen to identify imaging markers predictive of response.   "
104200|NCT01922219|"     The purpose of this research study is to learn whether specific types of brain imaging and     psychological testing can predict how much benefit patients with depression will receive from     a well-studied psychotherapy for depression, called cognitive behavioral therapy (CBT), and     how the brain imaging and psychological tests change with treatment. We will also be     comparing brain scans from this study between individuals suffering from depression and     volunteers without depression.      This study offers 14 sessions of one-on-one cognitive-behavioral therapy (CBT) over twelve     weeks, administered by an experienced doctoral-level psychologist or psychiatrist.   "
104201|NCT01922206|"     The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a     full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing     their serostatus to their young age 6 - 14 year old), well children. A pilot study of the     intervention has recently been completed (R01 MH077493) and met its major aims. The basis for     development of the pilot intervention was work from three R01s (MH057207, currently Yr. 14)     designed to longitudinally assess MLH and their children. Within that work, several studies     were conducted on maternal disclosure, suggesting disclosure is difficult, and outcomes for     MLH and children could be improved by intervention. The pilot study, known in the community     as Teaching, Raising, And Communicating with Kids (TRACK), was based on integrative     disclosure theory. Results of the pilot trial indicate that those in the intervention group     were six times more likely to disclose their HIV/AIDS status to their child than those in the     control group (O.R. 6.33); by the 9-month follow-up 33% of intervention MLH disclosed,     compared to only 7.3% of the control group. Perhaps more importantly, the intervention     group's emotional functioning and their satisfaction improved significantly following the     intervention, compared to the control group. Similarly, child mental health indicators among     children of intervention MLH were significantly better than control group children at     follow-ups. In this study, TRACK II, we propose to conduct a full-scale trial of the     intervention in two sites: (1) Los Angeles county (Site 1, where the pilot trial was     conducted), which will include a high proportion of Latina families and a smaller proportion     of African-American and White families; and (2) Atlanta, Georgia (Site 2, where the primary     consultant on the pilot trial conducts research), which will include a high proportion of     Southern African-American families, as well as White families. MLH and their children (N =     440 total; 110 mothers and 110 children per site, n = 220 per site) will be assessed at     baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned to the     intervention or control. Aims are to:        1. facilitate disclosure of the mothers' HIV status to the children, which will include          secondary aims of:             1. increasing mothers' self-efficacy to disclose and respond to child questions               regarding HIV;             2. reducing mothers' fears regarding disclosure and stigma;             3. improving maternal knowledge of child development and how to provide appropriate               levels of information given the age of the child;        2. improve MLH mental health indicators over time (i.e., depression, anxiety, quality of          life);        3. improve child mental health indicators over time (i.e., depression, anxiety, acting out          behaviors); and        4. improve family functioning indicators (e.g., cohesion, perceived closeness between          mother and child).   "
104202|NCT01922193|"     Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared     to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an Assisted     Reproductive Technology (ART) Program.   "
104203|NCT01922180|"     To describe Computed Tomography (CT) features associated with severe exacerbations of Chronic     Obstructive Pulmonary Disease (COPD).   "
104262|NCT01921413|"     The purpose of this study is to evaluate the clinical performance of the one-step Fyodor     Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the     diagnosis of Plasmodium falciparum malaria in febrile patients. A total of 1500 properly     consented children and adults presenting with fever (axillary temperature ≥37.5°C) or history     of fever in the last 48 hours (Group 1), 250 apparently healthy individuals (Control, Group     2), and 50 patients with Schistosoma hematobium and Rheumatoid arthritis (Group 3), will be     recruited. Matched urine and fingerprick (capillary) blood samples will be collected and     tested using the UMT and, Binax NOW® malaria rapid diagnostic test (blood test) and thick     smear microscopy, respectively. The overall agreement of the UMT results to the Binax NOW     analysis and thick smear microscopy will be used to establish UMT sensitivity and     specificity.   "
104346|NCT01920321|"     Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of     bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.      Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral     bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an     inflammatory airway and parenchymal injury and consequently fibrotic response resulting in     LVR;   "
104204|NCT01922167|"     Frailty is a clinical entity associated with an increase in risk for disease and death and     becomes more common as people age. Frailty has a strong relationship with the age-related     loss of muscle and strength, termed sarcopenia. Sarcopenia and frailty are strongly     associated with disability, especially in women. Adequate protein intake, the amino acid     leucine, and resistance exercise training have been individually shown to increase muscle     mass to varying degrees. However, no studies have investigated how a longer-term resistance     exercise training program with leucine supplementation when protein intake is optimized could     increase muscle mass in frail and pre-frail elderly women. In addition, this is the     population that stands the most to gain from such an intervention.      The purpose of this study is to investigate the effects of the amino acid leucine added to     resistance exercise training on muscle mass and physical performance in frail and pre-frail     elderly women with adequate protein intake. We hypothesize that combining leucine in diet     with an exercise program would be superior to exercise alone in stimulating muscle protein     synthesis and phosphorylation status of muscle cellular key-regulatory proteins, leading to     enhanced gains in muscle performance.      A total of 24 subjects will take part in this study, conducted at the McGill University     Health Centre (MUHC) Royal Victoria Hospital and the Institut Universitaire de Gériatrie de     Montréal (IUGM). All subjects will undergo adjustments to their diet to optimize protein     intake and a resistance exercise training program. Half of the participants will receive a     supplement of powdered leucine (an amino acid), and the other half of the participants will     receive a placebo in the same powder form. Neither the participants nor the study     investigators will know which participants are receiving the leucine nor which are receiving     the placebo.      Each subjects participation in this study will involve 4 total visits: 2 initial screening     visits followed by 2 two-day stays at the Centre for Innovative Medicine (CIM) of the     MUHC-Royal Victoria Hospital. These two stays will be spaced by 12 weeks of the intervention     (dietary adjustments, resistance exercise training, and the powdered supplement). The two     stays each consist of a meal test to assess each subjects metabolic responses to a meal, and     to obtain muscle biopsies necessary to measure the rate of protein accumulation in the     muscle. Simple physical performance measurements will be taken before and at the completion     of the intervention.      This study aims to better understand how the presence of aging affects the body's responses     to resistance exercise and how leucine, one of the amino acids that make up proteins, may     help build muscle. This in turn, could lead to defining combined diet and exercise strategies     to prevent muscle loss often seen with aging.   "
104205|NCT01922154|"     To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for     trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).   "
104206|NCT01922141|"     This study is designed to compare the blood pressure lowering efficacy of aliskiren, a     combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to     moderate hypertension. It will also compare the long-term safety of an aliskiren-based     regimen to a ramipril-based regimen   "
104207|NCT01922128|"     Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for     non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.   "
104208|NCT01922115|"     Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of     this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a     group that also has a higher baseline risk of cognitive dysfunction. Our objective is to     evaluate the effect of an anticholinergic medication on cognitive function in elderly women.   "
104209|NCT01922102|"     This study is designed to evaluate the efficacy and safety of two different dosing regimens     of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in     patients with visual impairment due to choroidal neovascularization secondary to pathologic     myopia (PM)   "
104210|NCT01922089|"     The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in     heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching     target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration     regimens.   "
104212|NCT01922063|"     Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained     from survivors of disc surgery that would have considered the type of postoperative care.      Objectives: 1) To evaluate the long-term effects of postoperative comprehensive physiotherapy     starting 1 week after lumbar disc surgery. 2) To assess the relative risk of segmental     instability in the operated segment 12 years following lumbar disc surgery.   "
104213|NCT01922050|"     Part 1:      To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once     daily treatment for two consecutive days      Part 2:      To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment     for two consecutive days compared to vehicle formulations   "
104214|NCT01922037|"     This multicenter, prospective study will evaluate the correlation of participant's     characteristics, including biomarkers, with predictive markers of clinical outcome in     participants with moderate to severe asthma initiating treatment with omalizumab. During the     48 weeks, participants will be evaluated and treated per investigator discretion and will be     followed from study entry until a maximum follow-up of 48 weeks, death, withdrawal of     consent, loss to follow-up, or study closure.   "
104215|NCT01922024|"     The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21     microorganisms and 19 genes associated with antibiotic resistance in 4 hours.      In this study, the performance of the Unyvero LRT55 Application shall be tested under     clinical conditions and compared to (1) a composite reference method (for non-atypical or     cultured microorganisms) or (2) a molecular PCR based reference method for the 3 atypical     microorganisms Chlamydophila pneumoniae, Legionella pneumoniae, and Pneumocystis jirovecii,     and for resistance genes.      PCR amplifications are followed by bi-directional sequencing, including comparison of the     test results Time to result will be compared for the Unyvero LRT55 Application and     standard-of care.   "
104216|NCT01922011|"     The purpose of the study is to determine whether daptomycin is effective and safe in the     treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or     nafcillin (or β-lactam equivalent). The primary hypothesis is that daptomycin is non-inferior     compared with vancomycin (or equivalent) or nafcillin (or β-lactam equivalent) with respect     to improvement in Pain, Inflammation, and Limb Function on or before study Day 5.   "
104293|NCT01921010|"     The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction     accomplished by the addition of niacin to statin medication would improve endothelial     function as compared to LDL-C reduction alone in patients with and without coronary artery     disease and the combination of low HDL-C/high triglycerides.      The combination of lipid lowering therapy would have beneficial effects on markers of     inflammation. These benefits would be particularly evident in women.   "
104347|NCT01920308|"     The purpose of this study is to assess the deliverability, clinical utility and effectiveness     of the 5 mm diameter size offering of the LifeStent® Vascular Stent   "
104348|NCT01920295|"     Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy     compared to second choice after failed medical therapy   "
104549|NCT01917682|"     To collect data on the routine patterns of use, safety and effectiveness, including the     clinical and technical performance of the CorPath 200 System, in the delivery and     manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.   "
104217|NCT01921998|"     Side effects from chemotherapy can be severe in some patients leading to admission to     hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood     test that could predict patients who will go on to develop severe side effects could be     useful and might allow early intervention with medicines to reduce the severity of the     symptoms and prevent admission to hospital.      This study will collect blood samples from patients with lymphoma or sarcoma who are     receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the     side effects that most commonly results in hospital admission, of less than 20%). It will     assess whether changes in blood proteins (biomarkers) taken 2 days after the 1st     chemotherapy can predict subsequent severe side effects throughout the 4 months of     chemotherapy. In addition the investigators will collect data on quality of life and contact     with medical professionals to assess the costs of chemotherapy toxicity to both the patient     and health service. This will allow us in the future to model the cost effectiveness of using     biomarkers in this manner to try and reduce chemotherapy toxicity.   "
104218|NCT01921985|"     This study investigates if the administration of terlipressin reduces complications after     major liver surgery.   "
104219|NCT01921972|"     This is a national multicenter, double-blind, randomized, parallel-group trial of 12 months     in duration. Following a 4 week wash-out period, subjects will be randomized to one of 2     treatment groups: (1) galantamine CR 24 mg/day with dose-titration over twelve     weeks[maintenance phase from week 9], (2) a combination of galantamine CR 24 mg/day plus     memantine 10 mg b.i.d. with a dose titration of sixteen weeks (12 weeks for galantamine     [maintenance phase from week 9], additional 4 weeks for memantine).   "
104220|NCT01921959|"     The purpose of this ancillary study is to determine whether a behavioral weight loss     intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive     ripple effect on weight and health of partners and children/offspring.   "
104221|NCT01921946|"     A phase Ⅰ study to evaluate the pharmacokinetic interactions and safety between fimasartan     and rosuvastatin in healthy male volunteers.   "
104222|NCT01921933|"     The objective of this study is to assess the performance and safety of the Optiflow     Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous     arteriovenous fistula (AVF) anastomoses.   "
104223|NCT01921920|"     This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence     Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by     AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck   "
104224|NCT01921907|"     A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic     keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a     double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be     treated by the active component.   "
104225|NCT01921894|"     This study of vitamin D is designed to assess both the safety and efficacy of potential doses     (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short     period of time (e.g. 4 weeks or less) compared to 200 IU/day.      In children with vitamin D insufficiency or deficiency who are at risk for severe asthma     exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000     IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day)     will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.   "
104226|NCT01921881|"     The goal of the study is to examine if healthy individuals that ingest St John's wort will     have a significantly difference in glucose tolerance.   "
104227|NCT01921868|"     The purpose of this study is to learn how treatment with acetyl-L-carnitine (ALCAR) will     affect the hearts of patients with Friedreich's Ataxia as well as how it may affect other     symptoms of Friedreich's Ataxia such as difficulties with balance, walking, or upper arm     function.   "
104228|NCT01921855|"     This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with     moderate or severe congenital hemophilia A or B with or without inhibitors. This is a     randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is     designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic     and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses     to be examined in subsequent studies.   "
104229|NCT01921842|"     The study is an evaluation of a nutrition and physical activity intervention in child care     centers in NC, CA, and CT.   "
104230|NCT01921829|"     This research study is a randomized clinical trial to evaluate if taking diuretics     (medications that increase urine production and help with fluid removal from the body) in a     standardized fashion (using a guideline for adjusting doses based on measured urine output)     could improve health outcomes in patients with cardiorenal failure or cardiorenal syndrome     (combined heart and kidney failure) with edema (too much fluid in their arms, legs, and/or     lungs). Under usual care, these patients are treated with diuretics and other medications in     increasing doses, but not necessarily to maintain a specific amount of urine output per day.     Current heart failure (HF) treatment guidelines do not provide any standard protocol, or     guideline, for adjusting diuretic doses. At the point when kidney function worsens to the     degree that the kidneys are no longer able to respond to the medications used to remove     fluid, either ultrafiltration (UF) or dialysis (also called hemodialysis [HD]) is typically     started in order to remove fluid. In both UF and dialysis, excess fluid is removed from the     body by using a machine. In dialysis, both waste products and fluid are removed and     electrolyte abnormalities are corrected. In UF, only fluid is removed. Both procedures use     the same machine. This study will test whether a Protocolized Diuretic Strategy (ProDiuS), a     plan for adjusting diuretic doses based on measured urine output, will improve clinical care     for cardiorenal syndrome. Such a plan for adjusting diuretic doses is needed to improve     symptoms, decrease the length of hospital stays and rehospitalization rates, and improve     health-related quality of life (HRQOL) in cardiorenal syndrome patients.   "
104231|NCT01921816|"     The investigators aim to examine the efficacy and safety of using a new citrate containing     commercially available solutions (Prismocitrate 18/0) as the regional citrate anticoagulation     in continuous renal replacement therapy for critically ill patients.   "
104294|NCT01920997|"     This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to     investigate the expression of their NEI network and urine metabolomics.   "
104232|NCT01921803|"     External beam radiotherapy (RT) is one of the standard curative treatment options for     patients with prostate cancer (PC). Several randomised trials have shown excellent long-term     biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of     delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks.     The sensitivity of different tissues to fractionation changes can be quantified through the     α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with     both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC is     lower than for most other tumors and approaches a value characteristic of late responding     tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is indeed     low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor     doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of     patient convenience and treatment cost are obvious. There is level I evidence that shows that     hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with     only a small increase in acute but not late toxicity when compared to conventional     fractionation RT schedules.      Results on different hypofractionation schedules have been reported, however the optimal     hypofractionation is not clear so far. In this randomised trial we would like to compare 2     different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25     fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late     toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be     registrated and compared. The study will be performed in 2 stages. For stage 1, sample size     was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel     (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design.     A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per     group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI     complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160     patients were included in stage 1. Sample size for stage 2 was calculated analogously     allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI     complications with an expected rate of 25%. When including 155 patients per group (310 in     total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients     out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The     sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10%     allowance for dropout.   "
104233|NCT01921790|"     The purpose of this study is to evaluate the efficacy and safety of avastin combined with     gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line     treatment in patients with untreated natural killer(NK)/T cell lymphoma   "
104234|NCT01921777|"     To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and     inflammatory immune response over a period of 72 hours after a second bout of strenuous     concentric exercise on bicycle (exercise #2).   "
104235|NCT01921764|"     The prevalence and consequences of musculoskeletal pain is considerable among healthcare     workers, allegedly due to high physical work demands of healthcare work. Previous studies     have shown promising results of physical exercise for relieving pain among different     occupational groups, but the question remains whether such physical exercise should be     performed at the workplace or in the private sphere at home. Performing physical exercise at     the workplace together with colleagues may be more motivating for some employees and thus     increase compliance. On the other hand, physical exercise at the workplace may be costly for     the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy of     workplace- versus home-based training on musculoskeletal pain. This study investigates the     effect of workplace-based versus home-based physical exercise on musculoskeletal pain among     healthcare workers.      The main hypothesis is that physical exercise at the workplace for 10 weeks compared with     physical exercise at home results in reduced musculoskeletal pain among healthcare workers.   "
104236|NCT01921751|"     This randomized phase II trial studies how well high or standard intensity radiochemotherapy     after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation     (nab-paclitaxel) work compared with gemcitabine hydrochloride and nab-paclitaxel alone in     treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in     chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing     or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor     cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy.     Giving radiation therapy in different ways and adding chemotherapy may kill more tumor cells.     It is not yet known whether high intensity radiochemotherapy after gemcitabine hydrochloride     and nab-paclitaxel is more effective than standard intensity radiochemotherapy after     gemcitabine hydrochloride and nab-paclitaxel or gemcitabine hydrochloride and nab-paclitaxel     alone in treating pancreatic cancer.   "
104237|NCT01921738|"     The aim of this study is to investigate the effects of Azithromycin (systemic and locally) on     the clinical and microbiological parameters of periodontal in patients with chronic     periodontitis.   "
104238|NCT01921725|"     The research uses hydrophilic-based dressing (KoCarbonTM) which is developed by Medical     Technology Company Limited (Bio-medical Carbon Technology; BCT) to investigate the wound     healing effects of activated-carbon-fiber-based wound dressing on different types of     wounds.The dressing is composed by three layers. The first layer is a material of     polyethylene terephthalate (PET) weave which is great breathable; Second layer, the activated     carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and contaminations.     It reduces the smell of wound and restrains the development of bacteria. In addition,     activated carbon has features of far-infrared and anion, which promote blood circulation,     speed up metabolism and shorten the time of wound healing. The third layer is a polyethlene     (PE) film, which touches the wound surface and provides the anti-adhesion effects.      The aim of this study is to investigate how the application of the dressing affects the wound     healing conditions on four different types of wounds, including general traumatic wounds,     elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the     characteristics of great fluid absorption and far-infrared features, the hydrophilic-based     dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair conditions.   "
104239|NCT01921712|"     The purpose of this study is to assess the safety and tolerability of PUR0200. In addition,     the study will look at the blood levels of different doses of PUR0200 and their affect on     lung function in COPD patients.   "
104263|NCT01921400|"     To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal     membranes using paraffin-embedded sections and post-delivery specimens respectively. In     parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ     hybridization technique and translate our in vitro findings to these in vivo samples.      Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the     placenta serve as a barrier that must be crossed during vertical transmission and that     cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain     conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV     in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV     regulation should be revealed.      Based on our preliminary data, our working hypothesis is that HCV Core protein is     differentially processed in cytotrophoblasts compared to hepatocytes.   "
104240|NCT01921699|"     Macrophages are derived from monocytes recruited to the tumor site and stimulated by specific     chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have been     postulated as being involved in the progression of cancer.      Based on our preliminary findings and on published data we hypothesized that     macrophage-induced chemoresistance (MIC) can promote survival of pancreatic carcinoma cells     during chemotherapy.      The overall goal of this study is to evaluate the mechanism of MIC in an in-vitro model of     Pancreatic ductal adenocarcinoma (PDA).      methods:        1. The human PDA cell line Panc1 will be grown in suitable conditions.        2. Macrophages will be produced by incubating mononuclear cells from the blood of healthy          donors in medium with M-CSF for 7 days.        3. TAMs will be generated by culturing these macrophages with tumor-culture conditioning          medium (TCCM) of PDA Cells for an additional 72 hours.        4. Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to          macrophages CM.        5. Cell proliferation will be quantified by light microscopy and by an XTT Cell          Proliferation Assay Kit.   "
104241|NCT01921686|"     The purpose of this project is to learn more about a new and promising way to diagnose acid     reflux disease using a very high-powered microscope. This special microscope provides much     finer detail than typical microscopes previously used for diagnosing reflux, and may help     doctors to better identify children with acid reflux.   "
104242|NCT01921673|"     Docetaxel is currently one of standard second-line therapy in patients with gastric cancer.     As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer,     dovitinib, dual VEGFR and FGFR inhibitor, may have the potential to improve the outcomes of     patients with gastric cancer. Therefore, we investigated the combination regimen of docetaxel     and dovitinib.   "
104243|NCT01921660|"     Use of dipole density mapping to identify activation in complex supraventricular tachycardias   "
104244|NCT01921647|"     The objective of this study is not only to explore pharmacokinetic interaction after single     oral administration but also pharmacodynamics interaction after multiple oral administration     of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808,     amoxicillin and clarithromycin in healthy volunteers   "
104245|NCT01921634|"     There is great variation seen in the incidence of appendiceal endometriosis. The variation is     most likely multifactorial, but method with which the specimen is examined may play a role.     If analysis using more cuts is used, appendiceal endometriosis may be diagnosed at a higher     rate.   "
104246|NCT01921621|"     This study examines in a prospective, randomized and blinded study design the impact of a     proficiency based training methodology on the acquisition of arthroscopic surgical skills     employing both a dry shoulder simulator model, and cadaver specimens for the demonstration of     surgical skill proficiency.   "
104247|NCT01921608|"     It is well known from a range of observational and epidemiological studies that the lifetime     risk of acquiring HIV among males can be significantly reduced via circumcision. Numerous     papers on the topic were published in the past two decades to elevate HIV prevention     awareness, especially in sub-Saharan countries.      Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men     in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the     government is continuing to study the PrePex™ device, developed to enable rapid adult male     circumcision in resource limited settings.      In February 2012, Rwanda has received WHO recommendation to scale up Adult Male male     circumcision (MC) using the PrePex device. Based on WHO recommendation (Use of devices for     adult male circumcision in public health HIV prevention programs: Conclusions of the     Technical Advisory Group on Innovations in Male Circumcision, March 2012, WHO/HIV/2012.7),     which recommended that the phased implementation include an active surveillance of the first     1000 clients to identify and record all adverse events and side-effects based on standardized     definitions. The active surveillance may change to passive surveillance after the first 1000     clients, if the incidence of events is reassuringly low, as determined by independent review.   "
104248|NCT01921595|"     The purpose of study is to compare the effect of coagulation profile in patients receiving     intraoperative balanced salt colloid undergoing spinal cord tumor surgery.   "
104249|NCT01921582|"     The purpose of this study is to determine whether methylphenidate is effective in the     treatment of binge eating disorder, in a randomized controlled trial extended release     methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight     or obese adult females.   "
104250|NCT01921569|"     The purpose of this study is to determine whether micronized dehydrated human amniotic     membrane (dHACM) suspension is more effective in reducing inflammation than conservative     measures alone when used to treat acute/early lateral epicondylitis.   "
104251|NCT01921556|"     Background The Swiss health ministry launched a national quality program QualiCCare in 2011     to improve healthcare for patients with COPD.      The aim of this study is to determine whether participation in the COPD quality initiative     (QualiCCare) improves adherence to recommended clinical processes and shows impact on     patients COPD care and on quality of life in patients with COPD.   "
104252|NCT01921543|"     The main aim of this trial was to investigate whether patients suffering from treatment     refractory- Major Depressive Disorder (MDD) can benefit from DBS (Deep Brain Stimulation) in     the brain areas known as inferior thalamic peduncle (ITP) and/or Capsula Interna/Bed nucleus     of the stria terminalis (CI/BNST)   "
104264|NCT01921387|"     This phase I/II trial studies the side effects and the best dose of radiolabeled monoclonal     antibody when given together with combination chemotherapy before stem cell transplant and to     see how well it works in treating patients with high-risk lymphoid malignancies. Radiolabeled     monoclonal antibodies, such as yttrium Y 90 anti-CD45 monoclonal antibody BC8, can find     cancer cells and carry cancer-killing substances to them without harming normal cells. Giving     chemotherapy before a stem transplant stops the growth of cancer cells by stopping them from     dividing or killing them. Stem cells collected from the patient's blood are then returned to     the patient to replace the blood-forming cells that were destroyed by the radiolabeled     monoclonal antibody and chemotherapy.   "
104265|NCT01921374|"     The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns.     During its progression there is loss of mobility, swallowing difficulties and a significant     reduction in respiratory capacity. Due to the severity and consequences, is inevitable the     need for a caregiver, that normally rely the mother.   "
104253|NCT01921530|"     Degenerative spondylolisthesis describes the slip of one spinal segment relative to the     adjacent segment. It is usually associated with spinal stenosis (which limits one's ability     to walk and stand) and is the most common indication for surgery in adults over age 65 years.     A variety of surgical techniques are available; the most common are the Posterolateral     Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody     Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed     within the cleaned out disc space between the vertebral bodies being fused. Although this     approach achieves a good fusion rate and deformity correction it is associated with a higher     surgical cost and potential intra-operative complication rate. What is more, no consensus     exists as to whether IF provides better patient rated functional outcome and quality of life.     If the advantages of IF do not translate into superior patient rated outcomes, then the     risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine     if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The     investigators will conduct a prospective randomized control trial comparing these two     procedures. Our primary outcome measure will be the Oswestry Disability Index, which     evaluates spinal pain and function.   "
104254|NCT01921517|"     The response to a daily 10 minute session of low-magnitude mechanical stimulation (LMMS) on     bone in 100 postmenopausal women ages 45-65 years will be evaluated at baseline and 12 months     using high-resolution magnetic resonance (MR) imaging. Subjects will be assigned to an active     platform that produces vibrations or to a placebo platform that produces no vibrations.      The investigators propose to evaluate the hypothesis that LMMS applied to postmenopausal     women ages 45-65 improves the mechanical integrity of bone while lowering marrow adiposity.        1. The investigators will optimize an integrated imaging protocol for high-resolution          structural MR imaging of the distal tibia and spectroscopic imaging-based quantification          of bone marrow composition in the lumbar vertebrae.        2. The investigators will further develop and validate micro-finite-element (FE) analysis          for quantitative assessment of trabecular and cortical bone stiffness and failure load          from high-resolution MR images of the distal tibia.        3. The investigators will apply the methodology of Aims 1 and 2 (above) in a          double-blinded, randomized, placebo-controlled study to a cohort of 100 healthy          postmenopausal women in the age range of 45-65 years, studied at baseline and 12 months          after having been subjected to 10 minutes daily of either 30 Hz/0.3g stimulation or          placebo treatment, monitored rigorously via electronic feedback.   "
104255|NCT01921504|"     The aim of the study is to investigate the effect of acupuncture treatment on functional     dyspepsia.   "
104256|NCT01921491|"     The purpose of this study is to determine whether dehydrated human amnion/chorion membrane     (dHACM) is more effective than another commercially available product or conservative     measures alone when used to treat diabetic foot ulcers (DFUs).   "
104257|NCT01921478|"     This retrospective, multi-centre, observational study will assess the daily practice patterns     and outcomes of the management of rheumatoid arthritis in patients treated with     RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will     be collected from medical records.   "
104258|NCT01921465|"     The purpose of the study is to evaluate whether outpatient cesarean section can be performed     in multiparous women without significant decrease in the parents' sense of security .   "
104259|NCT01921452|"     This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled     subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and     the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at     the same time.   "
104260|NCT01921439|"     The long-term goal is to improve the quality of life of children and their parents who smoke     tobacco by facilitating parental smoking cessation in a way that is easy to administer yet     effective. We aim to accomplish this goal by administering an interactive computer-based     program that will facilitate motivation and readiness to engage in smoking cessation by     providing personalized feedback about the financial and health effects of the parent's     smoking. We will compare the changes in motivation and readiness to quit smoking after the     parent has taken the computer-based program and compare them to the changes in motivation and     readiness to quit in parents who receive only information about the Oklahoma Tobacco     Helpline. We will also measure salivary cotinine levels in both parents and children, to     objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis     is that our computer-based program will cause a greater increase in motivation and confidence     to quit smoking in the group that receives the customized feedback than the group that     receives only information about the Tobacco Helpline. We also predict that both parent and     child cotinine levels will show a greater decrease in the group randomized to receive     personalized feedback.   "
104261|NCT01921426|"     The purpose of this study is to determine the safety, tolerability, and the highest dose of     GC4419 that can be given to patients with squamous cell cancer of the head and neck who are     receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419     for the following:        -  Effect on the incidence and severity of radiation induced oral mucositis;        -  Effect on the response rate of squamous cell cancer of the head and neck who are          receiving radiation therapy and chemotherapy;        -  Total concentrations of GC4419 that can be achieved in the blood;        -  Changes in proteins and genetics associated with oral mucositis;        -  Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open          the mouth);        -  Observe changes in genetic and molecular markers of oral mucositis;        -  Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube          use, etc.) of study patients;        -  Assess the overall quality of life in study patients with oral mucositis.   "
104266|NCT01921361|"     The purpose of this study to compare the efficacy of intravenous or intrathecal     dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for     elective surgery.   "
104267|NCT01921348|"     We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis     by changing the immune parameters and the psychological impact factors are associated with     ear acupressure treatment outcome.   "
104295|NCT01920984|"     To determine the vitreous levels of fractalkine, cysteine-rich 61 (Cyr61), and VEGF in     patients with PDR. Verifying that it is greater to that found in non-diabetic patients with     different non-angiogenetic diseases.   "
104268|NCT01921335|"     The purpose of this study is to test the safety of different doses of ARRY-380 in combination     with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2 metastatic     breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet been tested.     Both agents block the HER2 receptor, which is thought to be overactive in HER2-positive     breast cancer. It is thought that ARRY-380 and trastuzumab might work together because they     attach to different parts of the HER2 receptor and prevent it from functioning. Because HER2     positive breast cancer contains high levels of HER2 receptor, but normal cells in your body     generally do not, the drugs may be able to target the cancer cells. In addition, in     laboratory studies, ARRY-380 appears to have some penetration into the brain.   "
104269|NCT01921322|"     This is a prospective, randomized (open label), multi-center and post-market study. The study     is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily     injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in     China   "
104270|NCT01921309|"     To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic     Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for     use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.   "
104271|NCT01921296|"     Many women with breast cancer who are treated with aromatase inhibitor medications develop     difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor     medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).     Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril)     is a medication that was originally developed to treat muscle spasms. It may also improve     sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are     testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with     aromatase inhibitors.   "
104272|NCT01921283|"     There are clinical usefulness issues associated with bispectral index (BIS) for sedation of     endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep     sedation is incompletely described. The purpose of this study is to show that BIS-guided     sedation is safe and useful clinically and may provide stable sedation status to physicians     and patients.   "
104273|NCT01921270|"     The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport)     for use in Oromandibular Dystonia (OMD).   "
104274|NCT01921257|"     Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects   "
104275|NCT01921244|"     Children with Autism Spectrum Disorder (ASD) commonly experience behavioral challenges that     may be improved with pharmacotherapy, including difficulties with sleep, attention,     hyperactivity, impulsivity, anxiety, obsessive-compulsive behavior, mood swings, self-injury,     and aggression. While 34-58% of children with ASD take medication for such behaviors, there     is wide practice variation nationally and a lack of evidence to support the use of most     commonly prescribed agents. Complex clinical situations such as this where there is no clear     best choice regarding which behaviors to target and which medications to use lend     themselves well to the use of a Shared Decision Making (SDM) tool to ensure that     well-informed parent preferences shape every treatment plan.      The primary goal of this study is to modify a previously published decision aid about use of     medication to manage challenging behaviors in children with autism to make it easy to     implement in practice and then evaluate this version in terms of proximal decisional outcomes     and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral Pediatric     clinic will be enrolled and randomly allocated to intervention or control (treatment as     usual) groups. Initially, providers randomized to the intervention group will test and refine     the modified intervention. Once the intervention is finalized, eligible patients of     participating providers will be enrolled in the randomized controlled trial to test the     efficacy of the intervention. Following the trial, control group providers will be crossed     over and receive the intervention. Both proximal decisional outcomes (e.g. parent decisional     conflict, provider amount of SDM, parent knowledge of treatment options) and outcomes 3     months later (e.g. parenting stress, decisional conflict, and change in child behavioral     symptoms) will be assessed.      Approximately 10 providers and 240 of their patients with autism will be included in the     study. Chart reviews, parental surveys, and recordings of provider-parent-patient     interactions during the index visit will be collected at baseline (prior to physician     allocation), during the intervention trial, and after the control group has crossed over.     Between- and within-group analyses will examine factors associated with parental decisional     conflict and whether the intervention produces significant improvements in outcomes over and     above typical autism care. Analyses will include multiple linear regression modeling and     general linear models / repeated measure models, accounting for data clustered by provider.   "
104276|NCT01921231|"     Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal     anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective.     Lidocaine has been the well-known choice for this procedure. However, it is associated to     transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have     been performed, for example, the use of small doses of long-acting agents and the use of     additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk     of transient neurologic symptoms. We design and plan a randomised clinical trial to show if     hyperbaric prilocaine 2% would be an alternative.   "
104277|NCT01921218|"     The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in     preventing antibody formation in patients with chronic failing kidney transplants. This study     is a randomized study of first-time kidney transplant patients who have worsening kidney     function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA).     Patients must be eligible to get a second transplant. They must have completed or be actively     undergoing evaluation for re-listing for a second transplant. Patients will be randomized to     either convert to belatacept or continue on calcineurin inhibitor-based therapy.   "
104278|NCT01921205|"     Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other     Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently     have uncontrolled partial onset seizures.   "
104279|NCT01921192|"     Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated     with extracellular matrix changes. Many studies demonstrated that high levels of this     aminoacid in diabetic patients increases significantly the risk of the development of this     pathology. This study has been undertaken to investigate the role of homocysteine and its     cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic     retinopathy.   "
104292|NCT01921023|"     This clinical investigation is being undertaken to examine the performance of the CE marked     Proxima System - a patient attached blood gas analyser.      The study forms an element of the Post Market surveillance plan for the Proxima system and     will also generate method comparison data to allow Sphere Medical to submit the Proxima for     FDA regulatory clearance.   "
104296|NCT01920971|"     To investigate the effects of short-term and medium-term monochromatic infrared energy     therapy on patients with chronic low back pain (LBP) according to the International     Classification of Functioning, Disability and Health.   "
104280|NCT01921179|"     One of the most pressing concerns within the VA currently is the provision of interventions     that address the cognitive as well as emotional problems faced by Veterans with concurrent     mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain     injury influences how people think, act, and feel. This may include how people pay attention,     keep information in memory, organize plans for achieving important goals, and manage stress.     Another purpose of this research is to learn more about the effects of cognitive training on     the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in     the short- and long-term. With this research, the investigators hope to better understand and     treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.   "
104281|NCT01921166|"     The purpose of the study is (A) to determine if the following novel approach improves the     live birth rate with In-Vitro Fertilization (IVF) for women with a poor prognosis due to     diminished ovarian reserve:        -  ovarian stimulation with medications that are effective in women with diminished ovarian          reserve but adversely affect the endometrium        -  oocyte retrieval and vitrification        -  fertilization and embryo transfer in a subsequent cycle with controlled endometrial          preparation B) To determine the optimal stimulation protocol for women with diminished          ovarian reserve incorporating oocyte vitrification      Women who are not eligible to participate in the Carolinas Medical Center (CMC) Assisted     Reproductive Therapy program because of an extremely poor prognosis will be recruited for a     prospective, randomized, open-label study to determine if a novel approach improves the live     birth rate with traditional IVF poor prognosis stimulation protocols. The novel approach     will incorporate one of two protocols utilizing medications that provide maximal ovarian     stimulation but have a temporary detrimental fertility-reducing effect on the endometrium. If     ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes     vitrified (stored in a glass-like state in liquid nitrogen). At a later time, oocyte     warming and fertilization will be performed in a subsequent cycle, in which the endometrium     has been prepared.      Key points include:        -  Randomization to one of two ovarian stimulation protocols that have been shown to have a          detrimental effect on the endometrium, and therefore are rarely used in a fresh IVF          cycle        -  Oocyte vitrification is considered to be an investigational procedure by the American          Society of Reproductive Medicine (ASRM), and should only be performed under the          supervision of an IRB. With oocyte vitrification, ovarian stimulation and oocyte          retrieval can unlinked from embryo transfer, allowing embryo transfer to occur in a          more optimal environment        -  Endometrial preparation is routine for frozen embryo transfer   "
104282|NCT01921153|"     The primary objective of this study is to test effectiveness of an environmental intervention     designed to encourage healthy food intake during meals. It is hypothesized that fruit,     vegetable, whole grain, lean protein, and low-fat dairy consumption will increase during the     intervention. It is also hypothesized that nutrition knowledge, attitudes, and behaviors will     change as a result of the intervention. The findings from this study will provide insight     into the applicability of this intervention in military dining facilities.   "
104283|NCT01921140|"     This is a 3 part study for patients with solid tumours. The purpose of Part A is to measure     the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after     eating and the effect of olaparib on QT interval following a single oral dose of olaparib     tablets. Part B will determine the effect of olaparib on the QT interval following multiple     oral dosing. Part C will allow patients continued access to olaparib tablets and will provide     additional safety data collection.   "
104284|NCT01921127|"     This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD     patients new to ICS/LABA combination therapy.   "
104285|NCT01921114|"     The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally     Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to     another commercially available PICC.   "
104286|NCT01921101|"     The investigators propose a prospective randomized clinical trail to evaluate the impact of     intensive medical nutrition therapy (IMNT) in patients with acute respiratory distress     syndrome (ARDS) or acute lung injury (ALI) on short and long-term outcomes. Participant's (N     = 200) will be randomized to receive either standard care (SC e.g. ad lib feeding of standard     food) or IMNT provided early as enteral nutrition (EN) and continued as intensive diet     therapy tailored to maximize oral intake until hospital discharge. Primary outcomes evaluated     include infections while hospitalized, immune parameters (CD4 and CD8 cells, serum IL-10 and     leptin levels, numbers of T regulatory cells and markers for T cell anergy), days on     mechanical ventilation, in the ICU and hospital , and changes in fat free mass(measured by     dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip     strength), fatigue (measured as distanced traveled in 6-minute walk) and pulmonary function.   "
104287|NCT01921088|"     The purpose of this study is to determine the potential efficacy of real-time functional     magnetic resonance imaging neurofeedback (RT-fMRI-NF) in regulating brain activity and     psychophysiological functions.   "
104288|NCT01921075|"     The main goal of the present study was to provide a technical basis for future studies     assessing the role of cardiac lipids. More specifically, non-invasive MR-Spectroscopy (MRS)     techniques will be used in this study to:        1. assess the methodological reproducibility of MRS-measurements of cardiac lipids in          humans        2. investigate physiological variations of cardiac lipids by measuring day-to-day changes          under identical conditions        3. determining diurnal variations of cardiac lipids in humans   "
104289|NCT01921062|"     The aim of this study is to determine whether motor imagery training during the     immobilisation period in patients with a distal radius fracture, results in an improved     functional outcome compared to patients who do not perform motor imagery.   "
104290|NCT01921049|"     Patients undergoing major procedures in oral and maxillofacial surgery more often develop a     systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical     care therapy than patients with a comparable major surgery in other regions. The reasons for     this finding are unknown and have not been studied in depth so far. We hypothesize that     surgical trauma in this region might activate pro-inflammatory pathways. By examining the     proteome of patients at different stages (prior to the surgery, at ICU admission, on the     second postoperative day and when SIRS has ended clinically), we aim to identify the involved     pro-inflammatory pathways and identify possible target proteins that might be clues to     modification of postoperative SIRS in the future.   "
104291|NCT01921036|"     Seventy patients in cardiac rehabilitation with maximal exercise capacity less than 1.4 watt     per kilogram bodyweight will be randomized 1:1 into either an intervention training (IN)     group or usual care (UC). The IN patients will perform supervised endurance and resistance     exercise for approximately 90 minutes once a week and traditional cardiac rehabilitation     (TCR) once a week; the UC patients will perform TCR twice a week. The intervention is planned     for six months with a follow-up of a further six months. The primary investigation is     differences between IN and UC with regard to changes in exercise capacity (max watt/kgBW).   "
104297|NCT01920958|"     The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph     sealing after lymphadenectomy.   "
104298|NCT01920945|"     The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the     number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a     benign form of chronic daily headache that comes in two forms: one that resolves on its own     after months to years, or one that is difficult to treat and does not respond to preventive     or abortive medications. Some patients experience migrainous features such as nausea,     vomiting, photophobia, or phonophobia. BOTOX®, a treatment approved for chronic migraine,     will be injected into specific muscles of the head and neck area by your study doctor, to     evaluate its effectiveness in reducing or relieving NDPH days or severity. BOTOX has not been     approved for NDPH and this is the first time it will be used for treatment of NDPH. All     participants in this study will only receive BOTOX® and no other study drug.   "
104300|NCT01920919|"     This trial examines whether low grade suppression of the initial inflammatory process of     sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant     alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work     productivity, and whether this intervention prevents disease progression and reduces total     health-care costs.   "
104301|NCT01920906|"     Psoriasis is a chronic, debilitating skin disorder with an estimated prevalence of 2%.     Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into     plaques of varying sizes. Despite the great strides in the studies for psoriasis, it is still     unclear why psoriatic skin lesions start with small macules and then spread peripherally.      To study peripheral spreading of psoriasis, investigators plan to study small plaque     psoriasis in comparison to large plaque psoriasis in the Korean population. Large plaque     psoriasis is the most common form of psoriasis, seen in approximately 90% of all psoriasis     participants. Large psoriatic plaques are >5 cm in size and localize to the extensor aspects     of the elbows, knees, scalp, and genital area. On the other hand, small plaque psoriasis is     the common or typical form of psoriasis that occurs particularly in Korea and other Asian     countries. Korean small plaque psoriasis, even when chronic, remains <2 cm in size and is     widely distributed on the upper trunk and proximal extremities.      Investigators hypothesize that the expression of immune-related genes are different between     small and large plaque psoriasis. The study of a genetically homogeneous cohort,     characterized by the relatively high prevalence of small plaque psoriasis in the Korean     population, may filter out spurious signals while allowing for significant associations to     emerge from a relatively low number of participants.      By comparing small and large plaque psoriasis, it is expected this study could lead to new     understandings of the mechanisms involved in spreading of psoriatic plaques and provide new     insights into psoriasis development.   "
104302|NCT01920893|"     Primary Objective:      To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal     Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to     placebo.      Secondary Objectives:      To evaluate effect of dupilumab with regards to:        -  symptoms of sinusitis,        -  sinus computed tomography (CT) scan,        -  NPS in the sub-group of participants with co-morbid asthma,        -  Safety and tolerability.   "
104303|NCT01920880|"     Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever     considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is     caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior     Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic     injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of     penetration out of the ventral rectus sheet should be considered. This neurectomy however is     effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory     ACNES patients suffer from underlying pathologic pain disorders is subject to investigation,     by using quantitative sensory testing (QST).      Objective: To investigate nociceptive processing and possible underlying pathological pain     processing mechanisms in ACNES patients.      Study design: An observational case-control study.      Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an     existing database.      Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of     ACNES for both successfully treated and refractory patients in comparison to healthy     controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures.     Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.      Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST.     Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.   "
104304|NCT01920867|"     This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the     treatment of retinal and optic nerve damage or disease.   "
104305|NCT01920854|"     The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of     intravenously administered Soluble Ferric Pyrophosphate   "
104306|NCT01920841|"     The purpose of this study is to evaluate efficacy of two lipolytic creams differing in their     bases and demonstrate that their herbal ingredients can reduce the size of the thigh and     smooth the appearance of the thigh skin. It is hypothesized that creams with two different     cream bases containing herbal products that stimulate the lipolytic process through     stimulation of the beta-adrenergic receptor, with one cream base applied to each thigh daily     5 days a week for 4 weeks will reduce thigh girth and smooth the thigh skin compared to     baseline.   "
104307|NCT01920828|"     The purpose of this study is to learn about gait (walking) characteristics in MPS IVA and     possible changes in gait with enzyme replacement therapy.   "
104308|NCT01920815|"     In order to determine the effectiveness of medical therapy options to prevent enlargement of     the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This     feasibility study will gather accurate data on number needed to screen, changes in medication     use over time, and variance of the intended study endpoint.   "
104436|NCT01919151|"     Prognostic and predictive value of assessing the patients micrometastasis status in blood and     bone marrow when diagnosed GI cancer. 2 different patient subgroups are currently studied,     patients with cancer of the pancreas and patients with liver metastasis secondary to     colorectal cancer.      Our hypothesis is that patients with detective circulating tumor cells in the blood or     disseminated tumour cells in their bone marrow at diagnosis have a more advanced disease than     negative patients. This information may be of therapeutic interest.   "
104309|NCT01920802|"     The purpose of this pilot randomized clinical trial is to begin to delineate the     pathophysiological changes associated with antipsychotic associated metabolic side effects.     The study will be performed in 36 healthy people between the ages of 18 and 30, who have     never taken an antipsychotic, will undergo baseline laboratory tests before being randomized     to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The     primary outcome measure will be a correlation of early changes in leptin with weight gain. We     will also record changes in food intake, resting metabolic rate, oral glucose tolerance and     fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be     followed closely to monitor for safety throughout the 4-week study and will be discontinued     if there is a medically significant change in metabolic status or other antipsychotic side     effects. Metabolic assessments will be performed again at the time of discontinuation or at     the end of an 4-week period, and change from baseline in the two treatment groups will be     compared.   "
104310|NCT01920789|"     A randomized phase II study for medically inoperable stage I non-small cell lung cancer where     stereotactic body radiotherapy in three fractions to 66 Gy is compared with conventionally     fractionated radiotherapy to 70 Gy in 35 fractions.   "
104311|NCT01920776|"     The investigators hypothesize that lung ultrasound and echocardiography will benefit the     septic shock patients by making the treatment more precisely and rapidly. Septic shock     patients from multicenter will be enrolled in the study. They will be randomly divided into     two groups. The routine treatment group will receive routine treatment according to the SSC     guideline. The study group will receive additional ultrasound examination, which will decide     the improvement of therapy. Therapy change based on ultrasound results and the prognosis will     be recorded.   "
104312|NCT01920763|"     This pilot study will examine the safety and the clinical outcomes after minimally invasive     surgery (using a parafascicular technique guided by diffusion-tensor imaging) for     intracerebral hemorrhage in patients selected according to evidence-based criteria. The     investigators will compare 30 day and 90 day outcomes of patients who have surgery to that     predicted by previously reported models for recovery after ICH, and will also describe any     surgical complications related to the procedure.      The investigators hypothesize that this technique will have the same mortality rate and     function outcome, if not better, when compared to the outcomes predicted by previous models.   "
104313|NCT01920750|"     This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the     immunologically active proteins from the soluble/cytosol and insoluble cell wall of     Mycobacterium leprae. The overall objective is to generate new leprosy skin-test antigens,     equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early     diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease.     Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in its     early stages of infection. With the early administration of drug therapy, infected     individuals can then be cured of this disease before nerve damage occurs or nodules     (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative     volunteers, 18-40 years old, from within the staff of the Mycobacteria Research Laboratories,     Department of Microbiology, Colorado State University, Fort Collins, Colorado, will be     selected.   "
104314|NCT01920737|"     The purpose of the study is to find out whether the combination of chemotherapy drugs that     are routinely used in children with ALL, will be safe and effective in treating adult     patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy     drugs that are given in different combinations and in several steps. In adult ALL there is no     standard which drugs to give and how to combine them. Some leukemias have a chromosome     abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do     not (called Ph Negative). In this study we want to see whether this combination of     chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative     ALL.   "
104315|NCT01920724|"     Thailand has been facing with the double burden of malnutrition. Many studies in Thailand,     which aim to explore the situation, causes, and strategies to prevent obesity, have focused     on adults, adolescents, or school-aged children. Few studies have been conducted in preschool     children. Obesity or stunting during childhood increases the risk of being obesity in     adulthood and leads to chronic diseases. If obesity is established in adulthood, it is     difficult to reduce the excess weight. Thus, the prevention of obesity or stunting in young     children should be highly considered. Study of dietary pattern and reliable field methods to     measure fat mass (FM) in children may partly contribute to primary prevention of childhood     obesity. The deuterium dilution technique is an accurate and suitable method for children and     population-based studies. However, it has not been widely used in children in Thailand.     Hence, this study aimed to utilize the deuterium dilution technique for assessing body     composition and to determine the quality and quantity of dietary intake among children 3-5     years of age with different nutritional status. We conducted a cross-sectional study in 15     daycare centers in Nakhon Pathom and Samut Prakarn provinces. 120 preschoolers were     purposively selected according to their nutritional status: stunted, thin, normal, and     overweight/obese. Anthropometric measurements were conducted. Body composition was determined     based on total body water using deuterium dilution technique. Dietary intake data were     obtained using 2-day 24 hr recall.We hypothesized that stunted and obese children will have     more fat mass compared to the normal children.   "
104316|NCT01920711|"     The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the     reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF     with preserved ejection fraction.   "
104317|NCT01920698|"     The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness     of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous     MitraClip procedure and optimal standard of care therapy) in patients with severe secondary     mitral regurgitation.      This trial is a French, multicenter and randomized trial. Patients enrolled will be     clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months     and 24 months).   "
104437|NCT01919138|"     Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care     Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.   "
106171|NCT01896336|"     The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem     presentation 5 mg in the induction of sleep in patients with primary insomnia.   "
104318|NCT01920685|"     People with a schizophrenia spectrum diagnosis often experience distressing worries or     beliefs about others intending to cause them harm (also known as paranoia). Paranoid beliefs     are associated with significant distress and disruption to the person's life. This results in     high use of services and costs to mental health providers.      The National Institute of Clinical Excellence recommends that cognitive behavioural therapy     for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The     latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp,     making it a cost effective intervention.      Although improved outcomes have been obtained by therapies, CBTp has only small to moderate     effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is     intensive, expensive and takes up to a year. CBTp is therefore not widely available to     service users, resulting in inequalities in access to care.      The investigators are seeking to improve outcomes and accessibility of CBTp for people with     distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility     study of a brief therapeutic intervention, aimed at targeting and improving anxiety processes     that are causally implicated in paranoia (Freeman et al, 2015).      The investigators have preliminary evidence indicating that the pilot intervention, with     interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et     al, 2015). Participants also reported they found the therapy acceptable, enjoyable and     useful. Based on these results, the investigators have further modified the intervention. The     feasibility and efficacy of the therapy will be investigated in a randomised controlled     design (n = 34).      Please note the protocol has been been amended to exclude a pilot trial of a second brief     intervention targeting reasoning styles in paranoia, as since the initial protocol was     developed we have obtained data from two randomised pilot studies demonstrating its     feasibility and acceptability (Garety et al, 2015; Waller et al, 2015). A further pilot trial     of the reasoning styles intervention is therefore not indicated.   "
104319|NCT01920672|"     Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and     irreversible neurodegenerative condition, affecting also close to 15 million family     caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by     frequent night awakenings and nocturnal restlessness. Untreated sleep disruption in AD     patients is associated with increased rates of neuropsychiatric symptoms, daytime napping,     'sundowning' behaviors, cognitive and functional decline, and morbidity and mortality. The     added strain of sleep disruption is the primary reason family caregivers make the decision to     institutionalize AD patients. The circadian abnormalities in the sleep-wake cycle commonly     observed in AD patients occur more often in individuals with hypothalamic/ pituitary/adrenal     (HPA) axis hyperactivity. HPA axis hyperactivity may influence diurnal sleep-wake activity by     diminishing an AD patient's ability to respond to external zeitgebers which, in turn, can     further propagate HPA axis dysfunction. Thus, interventions to normalize diurnal HPA axis     patterns may be beneficial in treating sleep-wake disturbances. Nonpharmacologic treatments     are the first line therapy in AD patients with sleep wake problems, given the ineffective and     potentially harmful effects of pharmacologic agents. Current clinical sleep hygiene practices     in institutional (e.g., nursing home) settings holds promise for reducing disruptive sleep by     reestablishing circadian patterns in HPA functioning. These interventions include use of     timed and planned activities during daylight hours and creating a relaxing environment in the     evening. However little systematic work has been done to determine the efficacy of these     interventions in the home setting (where most individuals with AD reside).      We propose a pilot study to (a) characterize objective sleep parameters and behavioral     symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity in     a sample of community residing older adults with AD: (b) examine the effects of timed and     planned activities on subjective and objective characteristics of sleep, behavioral symptoms,     and HPA status; and (c) evaluate measurement approaches in home-dwelling AD patients.     Subjective (CG questionnaires) and objective (wrist actigraphy) characteristics of sleep and     behavioral symptoms will be measured in fifty-four AD patients being cared for at home by a     family. Patients and CG with then be randomized to receive an intervention of timed, planned     activities (TPA) or attention control (AC) condition. We will also obtain diurnal measures of     HPA activity including salivary cortisol and alpha amylase.   "
104320|NCT01920659|"     Physical activity is a powerful lifestyle factor that on average reduces risk for development     of diabetes and cardiovascular disease. Nevertheless, investigators have demonstrated that     following supervised endurance exercise training, 20% of subjects show no change in fitness     and 30% demonstrate no improvement in insulin sensitivity.      Our concept is that by using molecular profiling of blood/muscle samples investigators will     develop personalised lifestyle intervention tools. Further, revealing the biological basis     for a variable metabolic or cardiovascular response to exercise will enable us to propose new     targets and biomarkers for drug discovery efforts directly in humans. Using our established     OMICS approaches (RNA, DNA and Metabo-) investigators will generate classifiers that predict     the responses to exercise-therapy (fitness and insulin sensitivity). Classifier generation is     a statistical strategy for diagnosis or prognosis. Critically, investigators have a large     human tissue biobank, including subjects with insulin-resistance; young to elderly males and     females, as well as twins. Our SME partner has significant intellectual property and capacity     in the field of bio-prediction, with a proven track-record of collaboration with the team and     product development. Investigators will add to the diversity of our biobank by carrying-out     an exercise intervention study using a novel time-efficient strategy that investigators have     recently proven to be effective in reducing insulin resistance in sedentary young people and     in middle aged obese subjects. A time-efficient protocol is a critical as lack-of-time is a     key reason for not maintaining physical activity levels. Finally, investigators have a novel     out-bred rodent model that replicates high and low exercise training responses and     investigators will establish its suitability for future drug screening purposes. Because of     these substantial pre-existing resources investigators believe that our project has a very     high probability of delivering on its goals of improving the healthcare of European citizens.   "
104321|NCT01920646|"     The combination of poverty-related infectious and lifestyle-related non-communicable     diseases, both driven by malnutrition, causes a high burden for South Africa. Healthy and     nutritious diets for populations depend on availability and accessibility of a variety of     plant and animal foods, within a context that promotes and supports healthy behaviour. Food     based strategies, such as supplementation, food fortification, and diversification of crops,     are used to achieve optimal dietary requirements to combat malnutrition, including     micronutrient deficiencies. A more sustainable food based strategy is the (promotion of) use     of indigenous and traditional foods, such as African Leafy Vegetables (ALVs). Unfortunately,     several studies from all over Africa have shown that there is a shift from traditional diets     as result of the preparing techniques and the absence of women in homes. Furthermore,     indigenous and traditional foods are considered as poor people's food.      Against this background, a joint project between South Africa, Kenya and Benin is designed to     fill the gaps in knowledge in these countries regarding the availability, acceptability and     consumption and evidenced based benefits of foods from local biodiversity. The main aim of     the study in South Africa is to provide empirical evidence of how the role of biodiversity     can be translated into improved health status in contemporary poor rural and urban     communities in the North West Province of South Africa. In order to achieve this it is     important to gain knowledge on the possibility of using ALVs as a strategy to alleviate     micronutrient deficiencies. Therefore an intervention study to determine the effect of     selected ALV on the nutritional status (including zinc, iron, and vitamin A status) of school     children (grade R-4) residing in contemporary poor rural community in the North West     Province, South Africa has been designed.   "
104322|NCT01920633|"     This is a single visit study in which people with Down syndrome aged 12-30 will attend the     clinical center to undergo assessments to evaluate their eligibility for potential enrollment     in the future BP27832 Phase II clinical study which will evaluate the efficacy, safety and     tolerability of RG1662. Study participants may withdraw from this study at any time and for     any reason.   "
104323|NCT01920620|"     In this study we sought to determine whether inpatient weight loss counseling with post     discharge phone follow-up would result in weight loss at six months. Secondary endpoints     included weight change from baseline, changes in waist-to-hip ratios, assessment of weight     perceptions and changes in patient reported health outcome measures. To our knowledge, this     is the first randomized trial designed to evaluate the effects of an obesity intervention     with post-discharge follow-up in an inpatient general medicine population.   "
104324|NCT01920607|"     The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence     (defined as more than a major leak per week). The hypothesis of this non-inferiority trial     is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in     managing fecal incontinence   "
149168|NCT01331616|"     Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy     lead to optic neuropathy?   "
104325|NCT01920594|"     This study will test the hypothesis that GSK1278863 will reduce neurologic, renal, and/or     cardiac ischemia in patients undergoing elective descending thoracic aorta/thoracoabdominal     aortic aneurysm (DTA/TAAA) repair, a population known to be at high risk for ischemic events     from their underlying pathology and the surgical complexity required to address their     disease. Approximately 160 subjects will be stratified according to intervention type     (surgical or endovascular repair, with the latter limited to 50% of the total study     population) and randomized in a 1:1 fashion to treatment with GSK1278863 (300 milligrams     [loading dose] followed by 100 milligrams [mg]/day x 4 days) or placebo starting prior to     planned repair, through postoperative day 3. The duration of participation in this study is     expected to be approximately 4 to 8 weeks from screening to follow-up.   "
104326|NCT01920581|"     The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and     zopiclone) usage in an outpatient population of chronic users over 65 years in France using a     questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical     Manual of mental disorders) international standards.   "
104327|NCT01920568|"     This is a randomized, double-blind, double-dummy study designed to provide bridging data in     an Asian population to Amgen's studies of denosumab in subjects with bone metastases from     solid tumors. The study is designed to provide data to a large global dataset of phase-III     studies including breast cancer, prostate cancer, and all solid tumors, plus multiple     myeloma, to support the regulatory approval for marketing and patient access to denosumab for     the prevention of SREs in Chinese subjects with bone metastases from solid tumors. The     primary objective of this study is to evaluate and compare the percent change from baseline     to Week 13 in the bone marker urinary amino-terminal cross-linking telopeptide of type I     collagen (uNTx) corrected for urine creatinine (uNTx/uCr) in subjects treated with denosumab     to those treated with zoledronic acid. The study is designed to test the superiority of     denosumab over zoledronic acid.   "
104328|NCT01920555|"     This study is looking at the efficacy, durability, safety, and tolerability of multiple     single doses of Ketamine vs. active placebo for treating patients with treatment resistant     depression who are taking an antidepressant that is not working for them.   "
104329|NCT01920542|"     we hypothized dexmedetomidine could reduce the reduction of renal function after     cardiopulmonary bypass weaning in pediatric patients   "
104330|NCT01920529|"     Regular aerobic physical activity in short-term moderate asthma and severe:        -  Reduce the levels of inflammatory mediators        -  Improves functional capacity        -  Improves Quality of Life        -  Improved lung function        -  Reduces the sensation of dyspnea        -  Improves symptoms scores and medication use   "
104331|NCT01920516|"     In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic     and the survival in this group may be prolonged. In-transit melanoma metastases are often     confined to a limb. In this circumstance, treatment by isolated limb perfusion or isolated     limb infusion can be a remarkably effective regional treatment option. Isolated limb infusion     (ILI) was introduced in 1992 and is a technique used to deliver regional chemotherapy to     treat advanced melanoma confined to a limb. Regional chemotherapy with melphalan delivered by     isolated limb perfusion (ILP) or ILI are effective treatment options for in-transit melanoma     and are generally well tolerated.      ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69%     for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared to     ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of these     parameters potentially having an effect on outcome. ILP & ILI are used primarily as     palliative options when excision of in-transit metastases is unfeasible but can be used as an     adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma, and     can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight has     been shown to substantially decrease the rates of severe local toxicity while maintaining     complete response rates, but overall response rate is reduced.      Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs disease     is associated with similar complete response rates but lower toxicity than ILI for Lower     limbs E disease and with different physiologic sequelae despite comparable methods. The Upper     limbs appears relatively resistant to toxic effects of melphalan-based ILI as currently     performed, which suggests a potential for further optimization of drug dosing for Upper limbs     ILI.      Regional therapy is an excellent therapeutic modality for disease limited to a limb and     furthermore serves as an excellent model for scientific investigation, both clinical and     translational. In this study we want to collect data on isolated limb infusion of     chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of the     arm or leg that cannot be removed by surgery.   "
104332|NCT01920503|"     Cholangiocarcinoma is a rare and very aggressive neoplasm that arises from the biliary     epithelium, constitutes approximately 2% of all reported cancer, and accounts for about 3% of     all gastrointestinal malignancies. Up to date, there are many modalities to diagnosis and     treat with a range of sensitivity and specificity, and also the advantage and disadvantage of     its modality. Cholangiocarcinoma has a poor prognosis. Surgical resection offers the only     curative option and usually requires a major hepatic resection in addition to resection of     the cholangiocarcinoma. Unfortunately, curative resection is possible in only about 30% of     patients due to locally advanced disease, distant metastases or comorbidity in elderly     patients. Even after resection, the recurrence rate is approximately 60%, resulting in a low     5-year overall survival (OS).      Patients with intra-hepatic Cholangiocarcinoma (ICC) have a very limited benefit from     systemic chemotherapy, indeed, in unresectable cholangiocarcinoma Overall Survival with     systemic chemotherapy is less than 1 year. Since most cholangiocarcinoma patients develop     distant metastases at late stages only, locoregional therapy is an interesting therapeutic     strategy.      Locoregional therapy studies in patients with intrahepatic cholangiocarcinoma employing     radiofrequency ablation (RFA), transarterial chemoembolization (TACE) or external as well as     internal radiation therapy yielded promising results in the last couple of years.      TACE is safe and may be effective for prolonging the survival of patients with nonresectable     combined hepatocellular carcinoma (HCC) -cholangiocarcinoma, as compared with the     historically reported survivals of these patients. Tumor vascularity is highly associated     with tumor response. The patient survival period after TACE for combined     HCC-cholangiocarcinoma is significantly dependent on tumor size, tumor vascularity,     Child-Pugh class, and presence or absence of portal vein invasion.      Currently, few centers perform TACE therapy for unresectable Cholangiocarcinoma. Several     European studies have reported the efficacy and safety TACE for ICC.      The establishment of a registry to obtain the majority of Cholangiocarcinoma cases treated     with locoregional approach within and outside Europe can help the investigators evaluate a     larger and non-ambiguous sample population. This would help the investigators evaluate the     technical success rates, clinical success rates, feasibility and safety of TACE for ICC.   "
104333|NCT01920490|"     The investigators have shown that decoupling of brain networks when feeling guilty is the     first potential functional neuroimaging biomarker of risk of major depression. It remains     detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was     found while people felt guilty during functional magnetic resonance imaging (fMRI) relative     to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target for     interventions to reduce the largely increased risk of recurrent episodes in people who have     had one episode but are currently remitted. To our knowledge, however, there is no     proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected     and fed back to the participants after a short temporal delay in a real-time fMRI setting and     whether coupling can be increased through neurofeedback training. This project aims at     developing the first fMRI neurofeedback system to treat self-blame-selective neural     decoupling and to test its feasibility in people with major depressive disorder currently     remitted from symptoms.   "
104334|NCT01920477|"     Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening     autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel     monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is     expressed only in B lymphocytes.      The purpose of this study is to evaluate the efficacy, tolerability, and safety of ofatumumab     injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every     4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week 0 and Week 4)     in subjects with PV. It is anticipated that with sustained B-cell depletion in the presence     of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein)     autoantibodies in PV, that clinical remission of the disease will result.   "
104335|NCT01920464|"     this study has been request by french health authorities to evaluate the use of flixovate in     infants and its place in the treatment pathway.      this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of     Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the     population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012.     2/Description of the conditions of use of Flixovate® in infants aged less than 12 months     (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent     treatments etc.).   "
104336|NCT01920451|"     Sleep disturbance and posttraumatic stress disorder (PTSD) are common conditions in returning     Veterans, and both conditions are known to increase the risk of cardiovascular disease.     Research suggests that those with insomnia are at triple the risk of high blood pressure as     compared to normal sleepers, and that having both insomnia and short sleep increases this     risk to more than five times that of normal sleepers. These research findings suggest that     recently deployed Veterans with insomnia may be at increased risk of developing high blood     pressure, and this possibility is consistent with previous research. Vietnam era Veterans     with combat-related PTSD assessed in 1985 were twice as likely to have died of early-onset     heart disease relative to their non-PTSD counterparts when reassessed in 2000.      Evidence for impaired cardiac function in individuals with PTSD has been demonstrated across     several studies as well. Compared to individuals without PTSD, those with PTSD seem to have     lesser reaction to stress in terms of both heart rate and heart beat pattern. However, there     has been very little research examining the impact of behavioral sleep interventions on     health outcomes, and even fewer that are specific to a PTSD or Veteran population. The     purpose of this study is to determine if treating insomnia results in improved blood pressure     and cardiac function in recently deployed Veterans with PTSD. The findings of this research     will serve as pilot data for a future grant application testing the efficacy of     Cognitive-Behavioral Therapy for Insomnia (CBTI) for reducing cardiovascular risk in Veterans     with PTSD using a full-scale randomized trial design. We are hypothesizing that improved     sleep will be significantly associated with improved blood pressure and increased heart rate     variability (improved autonomic function) in adults receiving CBTI compared to those in a     wait-list control condition.   "
104337|NCT01920438|"     A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It     is a device frequently used in children that have feeding difficulties or are unable to     maintain normal growth via oral feeds. The same device may be inserted in two ways: the     percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible     camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray     imaging. Both methods of insertion have been used in children for more than 20 years, but it     is not clear which is the best method. Both methods are associated with complications,     including injury to other abdominal organs and leakage leading to sepsis. There are no     randomised controlled trials comparing the two techniques.      We aim to compare the outcome of both methods of gastrostomy insertion in children, with     emphasis on the complication rates. We have devised a complication score with weightage     assigned to each complication according to its severity.      A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per     group. The primary outcome will be the overall total complication rate.   "
104338|NCT01920425|"     The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView     to electronic and hand-written diaries for tracking medication state in the home.     Demonstrating comparable or superior results will further support use of the Kinesia HomeView     system as an outcome measure in clinical drug trials.   "
104339|NCT01920412|"     This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage     Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).   "
104340|NCT01920399|"     Investigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ     -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese     subjects.This study data will be used to support CAZ-AVI NDA in China.   "
104341|NCT01920386|"     A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of     Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in     Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.   "
104342|NCT01920373|"     1.0 BACKGROUND AND HYPOTHESES      1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in     every joint. These include the replication of cells that produce matrix, enzymes, protease     inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a     release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to     clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in     well-regulated balance. In the degenerative state this balance is upset producing     inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone.     Common causes of such alterations include increased loading, physical stress, and traumatic     injury to the joint.      1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that     they inhibit prostaglandin synthesis and decrease the activity of collagenase and other     enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic     agent that has several potential advantages over corticosteroids for the treatment of     degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to     have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores     intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances     joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich     plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis     have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering     articular function. Similarly, platelet rich plasma has shown to have better outcomes than     corticosteroid injections in the management of lateral epicondylitis, and better outcomes     than hyaluronic acid injections in the management of osteochondral lesions of the talus.      1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are     focused primarily on palliation by reducing inflammation and inflammatory mediators. This     study seeks to validate a therapeutic agent that has the potential to actively prevent the     progression of degeneration in addition to reducing pain and inflammation   "
104343|NCT01920360|"     The objectives are to evaluate the effects of immersion bath with sulphurous water in pain,     joint mobility and quality of life in patients with knee osteoarthritis. Patients will     undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for     ten weeks.      The expected results are: reduction of pain, improved range of motion of the lower limbs with     consequent increase in muscle mass improvement in postural balance, which will come due to     the reduction of pain and improvement movements of the lower limbs; greater independence in     performing the activities of daily living, better quality of life.   "
125904|NCT01637077|"     This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in     patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.   "
104349|NCT01920282|"     Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central     arterial stiffness and these effects may contribute to improved outcomes in hypertensive     patients. However, the results of several studies suggest that beta-blockers may actually     increase arterial stiffness. In contrast, there is limited evidence to suggest that     nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide,     reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few     studies have addressed this issue and all of these studies relied on indirect, blood pressure     dependent measures of arterial stiffness. In addition, none of these studies focused on     middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening     and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a     therapy to reduce large artery stiffness, particularly among the latter population, remains     unclear.   "
104350|NCT01920269|"     In laboratory and clinical studies, intravesical electromotive drug administration increased     mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive     urothelial bladder cancer. The investigators' aim was to compare transurethral resection of     bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection     and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in     patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will     be randomly assigned to: transurethral resection alone, transurethral resection and adjuvant     intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water infused over     60 minutes once a week for 6 weeks, or transurethral resection and adjuvant intravesical 40     mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA pulsed electric     current for 30 minutes once a week for 6 weeks. Patients in the intravesical adjuvant     electromotive and passive diffusion mitomycin groups who are disease-free 3 months after     induction treatment, will be scheduled to receive monthly intravesical instillation for 10     months, with the same dose and methods of infusion as initial assigned treatment. All     patients will be assessed for safety. The investigators' primary endpoints are recurrence     rate and disease-free interval. Analyses will be done by intention to treat.   "
104351|NCT01920256|"     Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals     are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved,     and patients become susceptible to devastating complications and greater health care     expenses. Studies have shown that regular monitoring and therapy adjustments are a     prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of     regular monitoring and therapy adjustments have been hindered by high clinic workload and     shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than     20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who     may lack the necessary expertise or time to deliver optimal disease management, particularly     when insulin is prescribed.      Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that     complement primary care, personalize the frequency of remote disease interventions and employ     infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and     patient satisfaction compared to usual endocrine clinic care, while reducing workload and     increasing the clinic capacity. The intervention clinic will employ regular remote     communications initiated by the endocrinologists, based on tailored individual plans.     Frequent remote monitoring and interventions will reinforce attainment of the therapy goals     and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will     decrease and it will be able to accommodate more patients with type 2 diabetes than     traditional endocrine clinics. The aims of the study are to test this new endocrine clinic     model in a clinical trial by monitoring clinical parameters, patient satisfaction and     clinical workload. The long-term objectives are to modify the current model of endocrine care     for patients with type 2 diabetes.   "
104352|NCT01920243|"     This study will look at the use of a telehealth version of a self management program in     individuals with both new onset and chronic traumatic spinal cord injuries. The program is     called Health Mechanics. It is meant to enhance self management skills related to neurogenic     bladder and bowel management to prevent associated problems and improve Quality of Life     (QOL). This program is based on the needs and strengths of individuals with SCI. It focuses     on enhancing skills, encouraging positive health behaviors, empowering people within their     own environments, and recognizing that people differ in their resources and abilities. The     skills that are part of the intervention are: attitude, self-monitoring, problem-solving,     communication, organization and stress management. This study will address those skills in     the context of bladder and bowel health, with expectations that these skills to be useful in     other areas of life as well.      The investigators hypothesize that individuals in the Health Mechanics intervention group     will:        -  show greater improvements in problem solving skills, healthy attitudes about disability          and knowledge of SCI management skills than will the control group        -  have greater adherence to recommended bladder and bowel management behaviors than the          control group        -  have fewer bladder and bowel complications than the control group        -  have higher levels of QOL than the control group      In other words, this study will investigate the effectiveness of a telehealth version of     Health Mechanics to enhance self-management skills related to neurogenic bladder and bowel     management in an attempt to prevent associated complications and improve QOL.   "
104380|NCT01919879|"     This is a multicentric, phase II and open label study.75 patients are expected to be     randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib     -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS     metastatic colorectal cancer.   "
104353|NCT01920230|"     The aim of this study is to examine the effectiveness of intervention based on mindfulness     and acceptance-commitment therapy (ACT) in the recovery from job burnout. The 8-week     intervention is delivered using jointly face-to-face group meetings and web-based program.     The study hypothesizes that the Muupu-program is more effective than the normal practices     when promoting work well-being in Finland. The participants are recruited from Finland.   "
104354|NCT01920217|"     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and     treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was     promising genetic biomarker for sepsis patients. The present study was designed to screen     several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to     be a new target for the treatment of sepsis.   "
104355|NCT01920204|"     Rationale: Patients with indolent or smoldering systemic mastocytosis can have severe     disabling symptoms. Almost all patients have fatigue, a compromised quality of life,     hampering normal functioning. Because this form of mastocytosis is not considered     life-threatening, mast cell eradication has never been applied and patients receive only     symptomatic therapy with histamine blockers. Midostaurin, a c-KIT inhibitor has shown     activity regarding symptom control and decrease of malignant mast cells in patients with     aggressive systemic mastocytosis (ASM) or mast cell leukemia   "
104356|NCT01920191|"     RATIONALE : IMA 950 is multi tumour-associated peptides (TUMAPs) vaccine, these peptides have     been identified on primary glioblastoma multiforme (GBM) cells. Poly-ICLC is a potent vaccine     adjuvant with broad innate and adaptive immune enhancing effects. IMA 950 and Poly-ICLC will     be administered to patients alongside standard primary therapy for glioblastoma. This     includes the alkylating drug temozolomide (TMZ). Effective vaccine-induced immune responses     associated with prolonged survival have been observed in glioblastoma patients during TMZ     adjuvant therapy, suggesting a possible synergistic effect. A second component of     glioblastoma standard treatment is external beam irradiation of the tumor site post-surgery.     As a side effect, potentially beneficial tumor-infiltrating immune cells may also be killed     by radiation. However, the combination of radiation with immunotherapy has been suggested to     be favorable both in pre-clinical models.   "
104357|NCT01920178|"     The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot     Laser device for the treatment of patients with onychomycosis who have been previously     treated with oral Terbinafine and failed.   "
104358|NCT01920165|"     The purpose of this study is to investigate whether there has been a change in the number of     hospital admissions for respiratory tract infections among children following the July 2007     introduction of a ban on smoking in public places in England.   "
104359|NCT01920152|"     The objective of this study is to compare the clinical efficacy of intra-articular injections     of autologous platelet rich plasma (PRP) vs hyaluronic acid (HA) for symptomatic early     osteoarthritis (OA) of the hip. Secondarily, this study aims to determine the feasibility and     safety of treating early OA of the hip with HA and PRP.   "
104360|NCT01920139|"     The study was performed to determine if either ultrasound guided core biopsy or fine needle     aspiration of an axillary lymph node has superior sensitivity in detecting metastatic     carcinoma from the ipsilateral breast.   "
104361|NCT01920126|"     The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent     acute kidney injury following open heart surgery in infective endocarditis patients.   "
104362|NCT01920113|"     Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is     a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but     it is limited to use alone. The investigators designed this study to compare the effect and     safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection     (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.   "
104363|NCT01920100|"     This project is based on a three-year program that aims to improve the knowledge of the     socioeconomic consequences of dementia in Norway. By including patients with and without     dementia in four different cohorts (from nursing homes, from memory clinics, home-dwelling     persons with dementia and elderly persons without dementia), the project's aim is to describe     tha course of dementia, the economical cost of dementia and to look into possible risk     factors for dementia.   "
104364|NCT01920087|"     The purpose of the study is to test the efficacy of ATNC05 in the treatment of Atypical     Facial Pain (AFP), also known as Persistent Idiopathic Facial Pain (PIFP). This research     project targets patients with chronic constant facial pain and excludes patients with     primarily paroxysmal pain.   "
104365|NCT01920074|"     RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to     severe pain associated with chronic anal fissure approved in June 2011 by the US Food and     Drug Administration (FDA) for adults. The purpose of this study is to assess the safety,     pharmacokinetics, and exploratory efficacy of RECTIV® in adolescents   "
104366|NCT01920061|"     This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with     either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will     assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients     with advanced cancer in order to determine the maximum tolerated dose in each combination.     The cisplatin combination expansion portion will evaluate the anti tumor activity of PF     05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).   "
104367|NCT01920048|"     This study will assess whether percutaneous coronary intervention (angioplasty of the heart     arteries) can improve survival and reduce hospitalization in patients with heart failure due     to coronary disease, who have been treated with the best contemporary medical therapy.   "
104368|NCT01920035|"     Localized cooling/hypothermia using the UroCool System during robotic-assisted radical     prostatectomy (RARP) surgery results in an improved overall return to continence, (defined as     not wearing any protective urinary pads), compared with standard of care in men presenting     for RARP.   "
104379|NCT01919892|"     Thirty subjects with a DSM-IV (Diagnostic and Statistical Manual, fourth version)diagnosis of     BPD during a depressive or hypomanic episode will be divided in two groups according to age     and time of illness. All patients will receive lithium (flexible therapeutic dose) for 6     weeks and improvement will be evaluated weekly using depression and mania rating scales; this     study also objectives to identify state/trait markers and predictors of response.   "
104369|NCT01920022|"     Women having abortions are at high risk for subsequent unintended pregnancy and repeat     abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long     acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the     most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies     in surgical abortion patients, show that quickstart of a LARC - i.e., inserting it during     the surgical procedure - is associated with substantially greater use of that method six     months later than requiring women to return later to get the device. However, today a     majority of women chose medical abortion. The clinical routine is to insert LARCs at the     follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of     the abortion treatment at home and do not return for a follow up. Thus, the possibility to     quick start a contraceptive method in medical abortion would be a major advantage especially     if this could be done at the time of administration of mifepristone.   "
104438|NCT01919125|"     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and     tolerability of single-dose administration of IDX719 in participants with normal hepatic     function and participants with varying degrees of hepatic impairment.   "
106172|NCT01896323|"     This is a single-center open-label study to compare how CC-223 (the study drug being     investigated) interacts with the drug ketoconazole.   "
104370|NCT01920009|"     Introduction:      In the United Kingdom(UK), about 838,000 men and 394,000 women have had a myocardial     infarction (MI) and will need secondary prevention medications. Longterm adherence to     secondary prevention therapies remains poor, nonadherence to medication in MI patients ranges     from 13-60%(1). Studies show that approximately one fourth of cardiac patients do not refill     their cardiac medications (2). Strategies to tackle the burden of non adherence could involve     pharmacy care and The New Medicine Service (which is a service provided by community     pharmacists to help patients on long term medications for chronic diseases) with a     motivational interview incorporated as part of the counselling session of a community     pharmacist. Communication of health providers with patients and between health providers     could also be an important strategy to improve adherence.      Cardiovascular disease is high in all ethnic groups as well as in the general population;     however it is the South Asians who have the highest prevalence of coronary heart disease     (CHD) (3). In addition, South Asians develop CHD at a younger age, often before the age of 40     years (3).      Aim of this study:      This study is to investigate the feasibility and potential impact of a pharmacy care     intervention involving motivational interviews and referral to the New Medicine Service in     coronary heart disease patients on adherence to secondary prevention medication and on     outcomes of coronary heart disease.      Method:      The study is designed as a prospective, controlled feasibility/pilot, intervention study. The     study has two phases.      In the intervention phase a total of 200 coronary heart disease patients discharged from the     London Chest Hospital will be enrolled into the study and followed up for one year.     Pharmacies from up to six London Boroughs will be invited to take place in the study.     Pharmacies will be randomised using a table of random numbers into intervention site or     control site. The pharmacists working in the intervention pharmacies will be invited for     training on the delivery of the intervention and on motivational interviewing. The     intervention will be performed by community pharmacists. Recruitment of patients will take     place in the hospital. In the interview phase 20 patients from South Asian backgrounds will     be invited for a telephone interview to study the effect of their beliefs and cultural     backgrounds in regards to their adherence to cardiac medication.      Outcome measures:      The primary outcome measure is self report adherence with coronary artery disease medication     employing a standard validated measure. Secondary outcomes are blood pressure and LDL-C (low     density lipoprotein cholesterol) in addition to data regarding the feasibility of the     intervention.      Analysis:      Both quantitative and qualitative data analysis will be performed.   "
104371|NCT01919996|"     This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory     post-marketing requirement to provide data regarding visual abilities in children taking     azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary     objective of the study is to examine the incidence of clinically significant worsening in any     of the following ophthalmic exams: best corrected visual acuity (distance), color vision,     Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of     approximately 30 pediatric patients taking azithromycin oral solution for treatment of an     authorized indication of use (pharyngitis/ tonsillitis).   "
104372|NCT01919983|"     Despite pharmacologic advances for the treatment of congestive heart failure (HF), sudden     cardiac death (SCD) and pump failure remain the leading causes of mortality in patients with     HF. Although, SCD is poorly understood, implantable cardiac defibrillators (ICD) have been     shown to be an effective, but costly therapy in preventing SCD. At present, left ventricular     systolic dysfunction is our best independent predictor of SCD, but only moderately predicts     those patients who will eventually benefit from the placement of an ICD and, in most cases,     left ventricular (LV) systolic dysfunction is a non-modifiable risk factor once acquired. As     a result, there exists an intensive search for biomarkers that could improve the prediction     of SCD and have the potential for risk factor modification.      Experimental and clinical evidence has established that inflammation plays a critical role in     stable coronary disease, plaque rupture, acute myocardial infarction, heart failure, and SCD.     Studies at our institution have demonstrated that elevated levels of hsCRP and Interleukin-6     are predictive of arrhythmic SCD; however, the mechanism of causing this increased risk is     unclear.      Another well-known risk factor for SCD is abnormal sympathetic innervation. The most robust     clinical test of sympathetic innervation to date is Iodine-123 Metaiodobenzylguanidine (MIBG)     imaging with gamma scintigraphy. MIBG imaging has emerged as one of our strongest predictors     of SCD by detecting sympathetic nervous system abnormalities in patients with HF. Preclinical     and clinical evidence suggests that myocardial inflammation adversely affects myocardial     innervation.      Based on these findings, the investigators hypothesize that elevated levels of inflammatory     biomarkers are associated with abnormal sympathetic innervation as measured by MIBG imaging.     The investigators aim to establish the strength of this association. This proposal will     leverage unique access to the largest, most extensively phenotyped cohort of patients who     have undergone ICD implantation for primary prevention of SCD, the PRospective Observational     Study of the ICD in SCD, (PROSE-ICD).   "
104373|NCT01919970|"     Autism spectrum disorders affect as many as 1 out of 88 children and are related to     significant impairment in social, adaptive, and school functioning. Co-occurring conditions,     such as anxiety, are common and may cause substantial distress and impairment beyond that     caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial     to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment     as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.   "
104374|NCT01919957|"     This study has two purposes: firstly, a better understanding of the neurobiological processes     underlying episodic memory and, secondly, the development of useful clinical applications for     epileptic patients, in particular the prediction of postoperative memory deficits and the     development of cognitive remediation therapies.      Memory performances during a fMRI experiment will be assessed in controls and epileptic     patients before and after the surgery.   "
104375|NCT01919944|"     The purpose of this study is to test whether VLY-686 can prevent or reduce the itch and     dermatological reaction observed after healthy volunteers are injected with Substance P in     comparison with placebo.   "
104376|NCT01919931|"     Candida albicans is one of the most common nosocomial infection and the onset relies on the     host immune status. The purpose of this study is to determine the immunological profile of     patients infected with Candida albicans, that could ideally lead to a strategy to identify     patients who could benefit from prophylaxis.   "
104377|NCT01919918|"     The purpose of the study is to find out more about the mechanism by which neural feedback     from the working muscle affects the development of central fatigue during exercise. Subjects     with chronic heart failure (HF) and healthy subject counterparts will be tested to determine     the mechanisms accounting for the premature fatigue characterizing HF patients during     physical activity.   "
104378|NCT01919905|"     The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin     D in industrially fortified mozzarella cheese baked with pizza.   "
104382|NCT01919853|"     The purpose of this study is to compare the effects of Mindfulness-Based Stress Reduction     (MBSR) to an attention control psycho-educational support group in treating cancer-related     fatigue (CRF) in early-stage (0-III) post-treatment cancer survivors with     clinically-significant CRF. The study will collect, store, and later analyze blood and urine     samples for several biomarkers that may be linked to persistent CRF in cancer survivors.   "
104459|NCT01918852|"     The study is a two-arm randomised phase III trial. Patients will be randomised to receive     capecitabine (arm A) or S-1 (arm B). Bevacizumab may be added according to the choice of the     investigator. Patients will be followed 3-weekly at the outpatient clinic, toxicity will be     assessed according to study protocol guidelines. Patients will be evaluated every 3 cycles     for response. Upon disease progression patients will be treated according to the local     investigators   "
104460|NCT01918839|"     This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI     Plus as compared to Restylane-L® in correction of nasolabial fold.   "
104383|NCT01919840|"     Main objective:      Determine whether by introducing thromboelastograph, the investigators reduced the number of     packed red cells received by each patient (median) compared to the usual protocol, in which     the indication for transfusion is based on laboratory tests: Prothrombin time, time activated     partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.      Design:      Prospective randomized controlled trial and single blinded.      Disease or disorder under study:      Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass     (CPB).      Primary endpoint:      median transfusion of packed red blood cells per patient. Study population Male and female     patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed     excessively.      Duration of treatment:      The coagulation monitoring methods tested are made from protamine administration to CEC     output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied     critics a) bleed excessively drains and until the patient stops bleeding (debit drains <a     150ml / h).   "
104384|NCT01919827|"     Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to     evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients with     diagnosis of idiopathic pulmonary fibrosis.      Primary endpoint: The aim is to evaluate the safety and feasibility of the endobronchial     administration of mesenchymal autolog stem cells derived from bone marrow (BM-MSC)in patients     with mild-to-moderate idiopathic pulmonary fibrosis.      Secondary endpoint:Assess the possible effect of the infusion of BM-MSC in stopping the fall     of pulmonary function in patients with mild-to-moderate idiopathic pulmonary fibrosis.   "
104385|NCT01919814|"     The purpose of the study is to determine whether Appethyl™, made from spinach, will reduce     appetite and hunger given on the same day of testing.   "
104386|NCT01919801|"     This study is being conducted to compare the safety and efficacy of icatibant with placebo in     the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in     Adults.   "
104387|NCT01919788|"     Diabetes mellitus type I (DMI) is characterized by lack of endogenous insulin and these     patients are 100% dependent on insulin substitution to survive. Diabetes mellitus type II     (DMII) is characterized by reduced insulin sensitivity and sometimes also reduced insulin     production, thus patients with DMII might also be dependent on insulin substitution.      Insulin is produced in- and secreted from the pancreas when blood glucose concentration rises     during- and after a meal. Insulin increases cellular uptake of glucose leading to lower blood     glucose concentration. Substitution with insulin is/can be necessary in DM, but at the same     time it induces the risk of hypoglycemia. This makes treatment with insulin a balancing act     between hyper- and hypoglycemia.      A hypoglycemic episode is a dreaded consequence of insulin overdosing, and also a very     frequent reason for hospital admission in patients with DM. Examples of hypoglycemic symptoms     may be; shaking, a sense of hunger, sweating, irritability progressing to lack of relevant     cerebral responses and eventually coma, convulsions and possibly death. People with diabetes     lose the ability to sense of low blood glucose with time, because of a lack of appropriate     counter-regulatory responses, hereby increasing the risk of severe hypoglycemia.     Understanding normal physiologic counter regulatory mechanisms during hypoglycemia is of     major importance to patients with DM and has the potential to change medical treatment in     diabetes, to reduce the risk of hypoglycemia.      Hypothesis: Hypoglycemia counteracts insulin signaling via hormone-dependent intracellular     counter-regulatory mechanisms, involving phosphorylation of specific signaling proteins.      Aim: To define counter-regulatory mechanisms in muscle- and fat tissue during hypoglycemia,     and to investigate the effect of insulin on lipid metabolism in healthy- and type I diabetic     subjects.   "
104388|NCT01919775|"     To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is     related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we     used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with     amnesia following treatment of ACoA aneurysm.   "
104389|NCT01919762|"     To assure the uniform collection, handling, storage and transport of patient whole blood     specimens and associated information to support validation of the T2 Bacteremia Assay.   "
104390|NCT01919749|"     This study will use proteomic and genomic profiling to analyze tumor tissue to see if     treatment selected by this analysis will benefit patients.   "
104391|NCT01919736|"     The objective of this project is to determine the effects of gait-retraining on articular     cartilage composition, gait mechanics, pain and function in persons with mild to moderate     knee osteoarthritis (OA).   "
104392|NCT01919723|"     This purpose of this study is to measure platelet response to ticagrelor and eptifibatide     bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated     after cardiac catheterization in patients undergoing non-emergent percutaneous coronary     intervention.   "
104393|NCT01919710|"     Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of     neutropenia induced by chemotherapy of cancer patients.   "
104394|NCT01919697|"     This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in     patients with Chronic Idiopathic Constipation (CIC).   "
104395|NCT01919684|"     This study is designed to evaluate the safety and tolerability of a range of single oral     doses of LGD-6972 in healthy subjects. Additionally, the study will characterize the     Pharmacokinetic profile in healthy subjects under fed and fasted conditions and in subjects     with Type 2 Diabetes Mellitus under fasted conditions.   "
104396|NCT01919671|"     The purpose of this study is to assess the effects in improving life self-care ability of     stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos     for 90 days.   "
104397|NCT01919658|"     The primary objective of the study is to compare motor strength in knee extension between two     groups of patients. One group receiving a proximal thigh block of the femoral nerve, and one     receiving a distal thigh block of the saphenous nerve. The secondary objective is to compare     the pain relief and functional outcomes in these two groups.   "
104398|NCT01919645|"     Physical exercise programs are effective and safe for the improvement of the sleep efficiency     in patients with Rheumatoid Arthritis.   "
104470|NCT01918709|"     Primary objective : To investigate pharmacokinetics after concomitant administration of     valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in     healthy male volunteers      Secondary objective : To investigate safety profiles after the administration of valsartan or     rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy     male volunteers   "
104473|NCT01918670|"     Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a     procedure that is currently used for the treatment of symptomatic atrial fibrillation     patients.      We have organized a multi-centric national survey of catheter ablation of atrial fibrillation     in order to have a feedback on the type of procedures being performed and the overall results     (freedom of atrial fibrillation) over an average follow-up of 18 months.   "
104399|NCT01919632|"     Background: The impact of demographic changes on workplace has increased the importance of     effective occupational preventive health programs. The primary goal of these programs is the     improvement of overall health status (and therefore increase productivity and decrease     healthcare costs) of the increasingly older workforce through positive lifestyle behavior     change.      A one- year preventive health behavior-change program for the employees of the company     British Petrol (BP) shall be scientifically evaluated. The initial stage of the program     consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of     supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups.     In the second phase of the program, the participants receive a recommendation to continue     exercise regularly unsupervised for one year, and receive monthly supervised exercise     training sessions. Clinical check-ups are performed at baseline (V1) at three months (V2) and     at 12 months (V3).   "
104400|NCT01919619|"     The goal of this clinical research study is to study the safety of REVLIMID® (lenalidomide)     when given with YERVOY® (ipilimumab) after a stem cell transplant. Researchers also want to     find out if lenalidomide given with ipilimumab may help to control leukemia, lymphoma, and     multiple myeloma.   "
104401|NCT01919606|"     The primary objective of this study is to determine the optimal of two different volumes of     EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP)     for prolonged postoperative analgesia in subjects undergoing open total abdominal     hysterectomy.   "
104402|NCT01919593|"     To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10%     povidone iodine in reducing blood culture contamination in pediatric patients.   "
104403|NCT01919580|"     Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the     treatment of oral cancer using Ga12 inhibitor.   "
104404|NCT01919567|"     Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the     Treatment of Oral Cancer Using SOX-9 Inhibitor.   "
104405|NCT01919554|"     The purpose of this study is to investigate the safety and tolerability of different doses of     sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust     mite-associated allergic rhinitis.   "
104406|NCT01919541|"     The investigators hypothesize that individuals who receive a personalized 4 week     prehabilitation program consisting of exercise and nutrition counselling with post-workout     whey protein supplementation will show, before colorectal surgery, improved insulin     sensitivity, inflammatory profile, and substrate utilization compared to baseline measures.     These results will translate into a higher functional capacity before surgery as demonstrated     by an improvement in 6-minute walking test.   "
104407|NCT01919528|"     The central venous catheterization (central line placement) is the common procedure performed     in the intensive care unit. This procedure is performed by percutaneous puncture of so called     'the central vein' and than advancement of the catheter over the guidewire (Seldinger     technique). The tip of the catheter is left in the superior vena cava in the vicinity of the     right atrium of the heart. Central veins are large veins in the human body passing the blood     into the heart.      Typical, clinical indications for the central line placement in the intensive care unit are     hemodynamic monitoring, volume monitoring, administration of medications, long-term total     parenteral nutrition, access for renal replacement therapy, difficult peripheral     catheterization.      There are two methods of the central venous catheterization in terms of visualization. First     and older is the blind technique. The operator is locating the anatomical landmarks and then     performing the entire procedure blindly by percutaneous puncture. This is called the landmark     technique. Second and new is the ultrasound-guided technique. The operator is locating the     vein using ultrasonography and then performing the entire procedure under ultrasonographic     visualization. The real time ultrasound-guided central venous catheterization became the     standard of care in recent years mainly because of safety issues (is regarded as safer than     landmark technique)      The catheterization of the axillary vein is not popular procedure in daily clinical practice.     But it can be reasonable and safe alternative to others, typically performed central venous     catheterizations like the internal jugular vein and the subclavian vein catheterizations.      The main intention of this study is to assess usefulness and safety of the real time     ultrasound guided axillary vein catheterization in mechanically ventilated patients admitted     to the intensive care unit.   "
104408|NCT01919515|"     The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform     similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of     primary molar teeth.   "
104409|NCT01919502|"     Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care,     the investigators would like to document the feasibility and acceptability of a     semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring     protocols to offer women and health care providers a new choice of diagnostic tools to     confirm early pregnancy. The pilot will help us to better understand how this tool     complements existing monitoring protocols. If a suitable addition or replacement to repeat     blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make     assisted fertility treatments more patient-friendly. This study seeks to test this innovation     by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test (Athenium     Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks after egg     retrieval/embryo transfer or intrauterine insemination.      The investigators hypothesize that the test, which can be used at home by women, will provide     confirmation of the presence of a pregnancy compared with standard serum hCG testing because     1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can     be used at home and thus earlier to determine presence of hCG.   "
104410|NCT01919489|"     High blood glucose levels in hospitalized patients with diabetes are associated with     increased risk of medical complications and death. Improved glucose control with insulin     injections may improve clinical outcome and prevent some of the hospital complications.     Increasing evidence indicates that incretin-based agents are safe and effective for the     hospital management of patients with type 2 diabetes (T2D).      Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the     treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous     insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food     intake and body weight and improve ß-cell function when administered subcutaneously.     Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma     glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy.     When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable     reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective     studies; however, have compared the efficacy and safety of liraglutide in the hospital     setting or after hospital discharge.      The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus     glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas,     nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in     medicine patients with T2D after hospital discharge.   "
104411|NCT01919476|"     Currently, about one third of all women entering pregnancy are obese. The prevalence of     metabolic disorders during pregnancy has increased concurrently with the rise in maternal     obesity. Although dietary interventions are used routinely to reduce metabolic disease in     non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant     women unless they develop gestational diabetes mellitus. In this study, the investigators     will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal     on the postprandial metabolic response. This cross-over, randomized control trial will     examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test     meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at     higher risk for gestational diabetes and the metabolic syndrome. The investigators     hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and     improves the postprandial lipid profile in these high-risk women.   "
104412|NCT01919463|"     The primary aim of this study is      - to explore the usefulness of abdominal compression on intubation.      Other aims include        1. to investigate the effectiveness and the efficacy of different manners of abdominal          compression and to analysis the reasons of their success and failure        2. to get the knowledge of the formation of colon loops and its frequency        3. to clarify the impact of intubation with loops on adenoma detection rate   "
104413|NCT01919450|"     The purpose of this study is to evaluate the consistency of quantitative peak stress     myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2     minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson)     injection. It is anticipated that there will be no or minimal difference between the four     delay times.   "
104414|NCT01919437|"     The purpose of this study is to develop the technology infrastructure for a mobile Web-based     cognitive and neuropsychological assessment of substance abusers, and to perform a pilot     trial using neurocognitive tasks designed to demonstrate that our system is statistically     comparable to current clinical practice.      The primary hypotheses are that results collected using a web-based data collection platform     will be comparable (but not necessarily equivalent) to data collected under controlled     laboratory conditions, that methamphetamine (MA) dependent participants will have worsened     neurocognitive performance compared to healthy volunteers, and the platform will be     acceptable to participants.   "
104415|NCT01919424|"     This study will compare the methacholine PC20 of two different modern-delivery aerosol     systems to determine if one may replace the other for use in clinical settings.   "
104416|NCT01919411|"     Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery.     There is minimal data to support this. The investigators' study will aim to demonstrate that     patients' quality of life and rate of post operative infection is the same whether they     receive or do not receive antibiotics post operatively. The investigators hypothesis is that     the disease specific quality of life of patients taking post-operative antibiotics is not     inferior to the quality of life of patients who do not take post-operative antibiotics, and     the rate of post-operative infections are the same. The investigators' specific aim is to     compare validated symptom scores between post-operative populations who are given or are not     given antibiotics. Rates of infections in the first 10 days after surgery will be recorded.     The investigators will also compare endoscopic grades of sinus cavities during the     post-operative follow up exams as an additional outcome measure.   "
104417|NCT01919398|"     The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to     the global recommended dose in Japanese participants with advanced solid cancers.   "
104418|NCT01919385|"     This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type     1 diabetes that are currently using an insulin pump.   "
104419|NCT01919372|"     This project is based on the contribution that could offer a technological system for a     continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic     complications in high risk population.      The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in     high cardiometabolic risk individuals of a telemedical platform integrating applications for     monitoring and providing recommendations to improve lifestyle habits (diet and physical     activity) in a healthier way.      The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12     month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic     assistance with a technological system and its ability to modify lifestyle habits, reduce     weight and cardiovascular risk associated parameters.      Previously to the clinical implementation, a pilot study for testing the telemedical system     will be made. Efficacy and security variables will be evaluated along the study.   "
104420|NCT01919359|"     Nutritional supplementation is more effective than placebo in the reduction of redness and     bruising following facial ablative laser resurfacing treatments and following soft tissue     filler injections to the lips and/or malar areas.   "
104421|NCT01919346|"     The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of     Delayed Graft Function following deceased donor kidney transplantation. Based on experimental     data and supportive observations in humans associating complement gene upregulation with     ischemic reperfusion (IR) injury, it is hypothesized that C5 cleavage is a key step in the     pathogenesis of ischemic reperfusion injury following transplantation. It is further     hypothesized that Eculizumab, a humanized monoclonal antibody that blocks C5 cleavage in     humans will be an effective prophylactic agent to prevent IR injury in high risk recipients.     This trial is a prospective, randomized study to test the efficacy of eculizumab vs. placebo     given once at the time of transplantation and once again 24 hours later in preventing delayed     graft function in first adult recipients of deceased donor kidneys.   "
104422|NCT01919333|"     This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy     on ovarian reserve as measured by serum antimullerian hormone and to study the different     effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the     non-ovarian pelvic surgery.   "
104471|NCT01918696|"     The purpose of this study is to determine whether a computerized intervention designed to     reduce anger-provoking interpretation biases will reduce suicide risk among individuals with     elevated levels of trait anger.   "
138542|NCT01471353|"     Combining Sorafenib with standard cytotoxic fluoropyrimidine therapy for advanced colorectal     cancer may provide clinical benefit when no other treatment remains.   "
104423|NCT01919320|"     Study Purpose      The purpose of this PAS is to confirm that patients implanted with the temporary Total     Artificial Heart (TAH-t) and supported with the Companion 2 Driver System have outcomes     similar to those patients implanted with the TAH-t and supported with the CSS Console. The     data collection mechanism for this study is the INTERMACS Registry.      Study Objectives      Primary Objective 1:      To confirm that patients implanted with the TAH-t and supported by the Companion 2 Driver     System have outcomes similar to those patients implanted with the TAH-t and supported by the     CSS Console.      Primary Objective 2:      To compare positive outcome rates for all TAH-t patients entered in the Intermacs Registry     initially supported with the Companion 2 Driver System to positive outcome rates for all     TAH-t patients initially supported by the CSS Console.      Primary Objective 3:      To review additional data (patient survival, adverse event rates and bridge to transplant     rates) to support the conclusion that the use of an artificial heart is reasonable and     necessary for the treatment of irreversible biventricular failure in Medicare/Medicaid     patients.      Secondary Objective:        -  To evaluate the incidence of adverse events (AEs). The AEs will follow the definitions          in the INTERMACS Registry.      Study Hypothesis: Primary Objective 1 The primary hypothesis is that the positive outcome     rate (defined as transplant , transfer to the Freedom Driver System support, or continuing on     implant driver support, whichever occurs first; assessed at three and six months     post-implant) for patients supported with the Companion 2 Driver System is non-inferior to     the survival rate for patients supported with the Circulatory Support System (CSS) Console.      Data Collection The data will be collected as defined in the INTERMACS Protocol and the     patients will be followed at one week, one month, three months and six months or until their     study endpoint is reached.      Data Analysis      Primary Objective 1:      Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes     for TAH-t patients who were implanted while supported with the Companion 2 Driver System     compared to TAH-t patients who were implanted while supported with the CSS Console.      Primary Objective 2:      Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes     for all TAH-t patients enrolled in the INTERMACS Registry.   "
104424|NCT01919307|"     This feasibility study will determine the tolerability of auricular acupuncture, compliance     with self-reported seizure tracking, and the quality of a proposed sham acupuncture protocol     to inform the design of a large, multi-center, placebo-controlled, double-blind study to     demonstrate the therapeutic effect of auricular acupuncture for the treatment of     Non-Epileptic Seizures.   "
104425|NCT01919294|"     The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis     (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months        1. improve severity of steatosis on liver biopsy (Primary Question)?        2. improve severity of associated steatohepatitis on liver biopsy?        3. reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)?      The work proposed here is an open pilot study of 10 patients, the main aim of which is to     assess the effect size of TRT in regard to these end points (regarding which there are no     published data), thereby allowing power calculations for a more definitive phase II trial.     Other aims would be assessing recruitment and consent rates, which would also inform the     design of the larger study.   "
104426|NCT01919281|"     The aim is to investigate whether strength training or high intensity interval training is     effective in improving insulin sensitivity, cardiovascular outcomes, body composition and     reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).      Few studies have examined the effect of strength training alone on insulin sensitivity,     reproductive outcomes and body composition in women with PCOS. Most previous studies on     aerobic exercise in PCOS have applied moderate exercise intensity.   "
104427|NCT01919268|"     This study aims to evaluate the effectiveness of the addition of the interferential current     to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low     back pain.   "
104428|NCT01919255|"     The purpose of this study to bowel cleansing evaluation of mixed two other type bowel     preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).   "
104429|NCT01919242|"     Gastric cancer is still one of the main health care issue and gastrectomy with lymph node     dissection is the only chance to be cure. Even though the development and standardization of     gastric cancer surgery, the morbidity of gastric cancer surgery was reported around 20% with     less than 1% of mortality in East. In contrast, around 40% of morbidity and 10% of mortality     was reported in West. There has been several indexes which can define the complications after     surgery, but adapting it into clinical practice is sometimes difficult due to the     heterogeneous opinion between surgeons. Thus for clear defining the complications after     surgery, consensus between many surgeons and prospective cohort study is necessary. The     purpose of this study is collecting the complications data after gastric cancer surgery and     defining it with every week meeting by at least 6 or more surgeons' discussion.   "
104430|NCT01919229|"     This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.   "
104431|NCT01919216|"     The placebo effect represents a potent treatment for MDD—placebo response in acute randomized     controlled trials (RCTs) of antidepressant medications averages 30%, and meta-analyses have     estimated the proportion of medication response attributable to placebo to be 50-75%. Patient     expectancy is the mechanism of placebo effects in antidepressant RCTs and has been positively     associated with medication response. Determining how expectancy alters the course of MDD     could lead to methods of optimizing placebo effects and improving the treatment of MDD. In     addition, investigating the neurobiology of placebo effects has the potential to elucidate     the pathophysiology of MDD and the mechanisms of action of antidepressant treatments. Brain     regions implicated in expectancy and placebo effects comprise prefrontal cortical (PFC)     areas, amygdala, insular cortex, rostral anterior cingulate cortex (rACC), and dopaminergic     reward pathways in the striatum. Pathological decreases in PFC and striatal function,     increases in limbic activity, and disordered connectivity between these regions have all been     observed in MDD, and the rostral and dorsal ACC have been repeatedly linked to antidepressant     treatment response.      Therefore, studying placebo effects offers a window into the functioning of the neural     circuits that are disturbed in MDD and improve with effective treatment. The goals of this     study are to determine whether expectancy affects the outcome of antidepressant     pharmacotherapy and to investigate the neural mechanisms of expectancy effects. These will be     accomplished by conducting a clinical trial randomizing adult outpatients with MDD to 8 weeks     of treatment in high vs. low expectancy conditions. The high expectancy condition will be     open administration of citalopram, while the low expectancy condition will be     placebo-controlled administration of citalopram. The neural mechanisms of expectancy will be     determined using functional Magnetic Resonance Imaging (fMRI) paradigms to investigate     treatment activation differences in brain regions associated with placebo effects and MDD.   "
104432|NCT01919203|"     This research attempts to find the optimum dose of remifentanil that can prevent the     unnecessary responses such as coughing, gagging, and movement when LMA is inserted during     sevoflurane induction in pediatric patients.   "
104433|NCT01919190|"     The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use     and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in     Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.   "
104434|NCT01919177|"     The main objective is to test the hypothesis that inorganic nitrate supplementation will: (1)     Improve exercise efficiency and performance; (2) Enhance the systemic vasodilator reserve     during exercise and specifically, the vasodilator response in exercising muscle; (3) Reduce     arterial wave reflections and arterial load; (4) Improve skeletal muscle mitochondrial     function in subjects with heart failure with preserved ejection fraction.   "
104435|NCT01919164|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2     trial of AS902330 administered intra-articularly in subjects with primary osteoarthritis of     the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the     efficacy and safety of different intra articular dosages of AS902330 (Sprifermin) in these     individuals.   "
104499|NCT01918332|"     This study aims to evaluate the efficacy and safety of the coadministration of valsartan     (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered     alone in patients with hypertension and hyperlipidemia.   "
104439|NCT01919112|"     Swallowing difficulties are common after a stroke and can lead to serious complications like     pneumonia and malnutrition. Unfortunately, there are no effective treatment for improving     swallowing in stroke patients.      Previous investigations have shown that recovery of swallowing functions occurs from     reorganization (rewiring) of the non-involved cerebral hemisphere. In this study, we     propose to investigate a new intervention, which combines, swallowing exercises with brain     stimulation targeted to the non-involved cerebral hemisphere, using low intensity current in     acute. We will only be enrolling hospitalized stroke patients. We plan to assess the safety     of this technique in this patient population and also assess its effect on improving     swallowing functions and swallowing physiology. During this time trial participants will     undergo standardized swallowing and neurological assessments as well as brain MRI scans.   "
104440|NCT01919099|"     Background:      - The National Institutes of Health (NIH) performs up to 100 allogenic stem cell transplants     (allo-HSCT) each year. Many studies already look at different problems that can follow a     transplant. But there are many types of transplants, diseases, responses, and treatments. An     organized study of this information could help researchers learn more about how often     transplant complications occur and what problems they cause. It could also lead to ideas for     future research. This study will focus on complications thought to be the most significant.      Objectives:      - To gather information on the complications that may occur after an allo-HSCT.      Eligibility:      - People over 2 years of age currently enrolled in an allo-HSCT study at NIH.      Design:        -  Visits for this study will be scheduled along with primary study visits. The number of          visits will depend on the primary study schedule.        -  At each visit, participants will answer questions and take physical exams.        -  The same questions and physical exams will continue for as long as they are in the          primary study.        -  In between visits, researchers might call participants to discuss their health. They may          also discuss the cases with the primary study doctors and other doctors. Primary          transplant study doctors will make treatment decisions.        -  When participation in the primary transplant study ends, participation in this study          will also end.   "
104441|NCT01919086|"     The purpose of this study is to see if researchers could get the same good results with less     toxicity by using this new approach.      We already know that the three drugs bortezomib, lenalidomide, and dexamethasone given     together at the same time are effective. Most physicians therefore treat patients with     multiple myeloma with the 3 drug combination. However, the researchers also know that the     three drugs given together result in more side effects than when only 2 drugs (bortezomib and     dexamethasone or lenalidomide and dexamethasone) are given. The researchers believe that all     patients may not necessarily need the three drugs to have good results. In this study, the     researchers will first treat your disease with bortezomib and dexamethasone. If the disease     is not well controlled with these 2 drugs, only then the third drug, lenalidomide, will be     added. By using this sequential approach we may reach the same good results with fewer side     effects.   "
104442|NCT01919073|"     The purpose of this study is to test the intervention using a more rigorous randomized     controlled trial design in order to demonstrate its efficacy compared to a wait-list control,     thus ensuring that change in behavior does not occur due to the passage of time alone. Using     this design will also allow us to improve upon our prior clinical research by facilitating     obtainment of post-treatment and follow-up data (as families in the clinical-only service     stop attending treatment when behavior improves, and have often not followed-up for booster     sessions or measure completion).   "
104443|NCT01919060|"     The purpose of the study is to investigate acute non-mechanical lower digestive tract     disorders should distinguish whether colonic lesions or not in critically ill patients   "
104444|NCT01919047|"     This study is to determine the following information.        1. The occurrence of adverse drug reactions in clinical settings.        2. Factors potentially impacting safety, effectiveness, and other aspects.   "
104445|NCT01919034|"     According to above basic findings, it is important to confirm those results in clinic. In     this branch, the investigators will use patient control analgesic (PCA) device to investigate     the consumption of morphine for patients undergoing hepatic surgery. Preoperative and     postoperative (before and after surgery) blood will be sampling (15cc/time) and y liver     tissue (10mm3) will be harvested to measure the expression of above molecules (TM, IL-20,     HD). Pain questionnaire will also be applied to evaluate their pain control quality.     Certainly, the morphine consumption and results from pain questionnaire will be correlated     with the molecule amount to figure out possible relationship between morphine consumption and     those molecules.      Patients undergoing abdominal surgery and using morphine pain control analgesia (PCA) device     will be involved. Pre- and Post- operative (after anesthesia and at the end of surgery) blood     sampling (total 30 ml) plus normal liver tissue (10mm3) e will be harvested. Above     protein(TM, IL-20, HD) amount change will be measured (ELISA for TM, IL-20 (serum) or     flowcytometry (white cells) for TM, HD, IL-20 expression, stain or blotting for skin tissue).     Patients will be included in this branch to check the correlation between morphine     consumption and protein expression. Pain questionnaire (BPI, McGill) will be applied for pain     evaluation. 2-D gel analysis will also be applied to screen further possible molecules.      Specific aims        1. To investigate the correlation of morphine consumption and the serum amount of IL-20, TM          or HD        2. To investigate the relationship between IL-20, TM, HD amount in liver tissue and          morphine consumption   "
104474|NCT01918657|"     The purpose of this research study is to learn about the medical effects, safety, and how the     Walnut Oral Immunotherapy (OIT) treatment affects your body (immune system). This type of     immunotherapy involves giving increasing doses of walnut allergen to gradually build up a     person's tolerance to walnut and at least one other tree nut. The goal of the study is to     determine whether participants can tolerate (eat) walnuts and at least one other tree nut in     their diet after stopping the study therapy.   "
104485|NCT01918514|"     Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain     relief.      In the pain clinic the investigators perform different injections as the standard treatment     for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine     with or without Steroids (Depo-medrol) is used for these injections.      The investigators' goal is comparing pain control in different groups adding the magnesium     sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong the     duration of analgesia and reduce the amount of narcotic dose.   "
104446|NCT01919021|"     Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on     quality of life and health care costs. When no structural cause is identified, patients are     diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of     stomach function that explain patient's symptoms and establish diagnosis. Another group are     diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis.     In some cases this is associated with delayed gastric emptying but not all.      24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish     normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia.      The utility of 3 different non-invasive investigations will be assessed. At screening the     nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every     minute and score symptoms every 5 minutes. The patient continues until they reach the maximum     tolerated volume.      Participants will then be randomized to undergo non-invasive imaging on two separate test     days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with     the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional     calories) of known breaking strength. The emptying of the stomach will be visualised with the     MRI alongside symptom recording.      Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling     will allow the rate of liquid and solid meal emptying to be visualised alongside symptom     recording.      Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30     minutes following ingestion of 400ml of milkshake and 12 agar beads.      Data will be analyzed to assess the association of objective abnormalities of gastric     function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS     will be compared to assess the optimal measurement of gastric function and emptying in this     clinical scenario.   "
104447|NCT01919008|"     This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose     tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the     population was also evaluated.   "
104448|NCT01918995|"     This study is to determine the safety, tolerability, and pharmacokinetics of two or three     repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy     supine subjects.   "
104449|NCT01918982|"     We aimed to see if aortic aneurysms could be followed-up by circulating endothelial     progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.   "
104450|NCT01918969|"     Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown     to be inversely correlated to aortic aneurysm size. However reference values have not yet     been determined. This study is aimed to determine reference values of CD34+144+CD14- et     CD34+VEGF-R2+CD14- in healthy men and women blood donors.   "
104451|NCT01918956|"     This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch     will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks)     compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).      The primary endpoint of the sudy is the comparison of the proportions of the patients who     have successfully reached the maintenance dose between the two treatment regimes.      A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as     safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with     PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.   "
104452|NCT01918943|"     Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment     option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and     degenerative scoliosis.      Many techniques evolved since then, from wiring, rods, pedicle screws, and recently     inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods     for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior     fusion techniques, two methods of achieving an interbody fusion from a posterior approach     have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody     fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more     common technique, requiring in some cases, complemental posterior fixation with pedicle     screws, facet screws or interspinous fixation devices like the Aspen device.      In this study, we address the clinical and radiological outcome of a novel technique using     standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar     approach.   "
104453|NCT01918930|"     The purpose of this study is to gain a better understanding about how the study drug MGA271     works. No test drug will be given in this study. Patients with easily accessible tumors at     the screening visit for participation in Study CP-MGA271-01 will be asked to participate in     this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle     biopsies.   "
104454|NCT01918917|"     The purpose of this study to search efficacy of intra-articular dexmedetomidine addition to     levobupivacaine for postoperative analgesia in arthroscopic knee surgery.   "
104455|NCT01918904|"     Calcinosis cutis refers to a group of disorders characterized by calcium deposition in the     skin (1). The disorders are classified according to etiology into the following types:     dystrophic, metastatic, iatrogenic, and idiopathic (1,2). Dystrophic calcification occurs in     the setting of varicosities, infection, tumors, and connective tissue disorders (1). The     connective tissue disorders most commonly associated with calcinosis cutis are systemic     sclerosis and dermatomyositis, although it has also been reported in patients with systemic     lupus erythematosus, undifferentiated connective tissue disorder, and mixed connective tissue     disorder (2). The pathophysiology of calcinosis cutis is not well understood, and there is a     broad range of severity seen, from benign localized, small nodules to large, severely     debilitating lesions (2). Although many therapies have been investigated for treatment of     calcinosis cutis, including calcium channel blockers, colchicine, minocycline, intravenous     immunoglobulin, and bisphosphonates, results have been mixed at best (2). Surgical removal is     sometimes feasible in the case of a localized lesion, however, recurrence after surgery is     common (2).      Recently, several authors have reported cases of dramatic resolution of dystrophic calcinosis     cutis lesions with topical sodium thiosulfate preparations (1,3,4). Systemic sodium     thiosulfate therapy is commonly used to treat calciphylaxis in patients with renal disorders     with very few adverse events (1). A search of the literature to date yields no formal studies     that aim to determine whether topical sodium thiosulfate is truly an effective therapy for     calcinosis cutis. As a result, patients are often treated with therapies that are unproven or     ineffective and their calcinosis cutis eventually leads to significant pain and disability.      Research Question:      Does treatment of dystrophic calcinosis cutis with topical sodium thiosulfate result in     diminution of the lesion and associated pain?      Objective:      The objective of this pilot study is to investigate whether topical sodium thiosulfate is an     effective therapy for calcinosis cutis. This study will also determine the feasibility of our     protocol and provide information to help direct a future full-scale trial.   "
104456|NCT01918891|"     The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the     effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community     transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower     their systolic blood pressure.   "
104457|NCT01918878|"     This is a prospective, multicenter, single arm study. The study group will be compose of     NVAMD patients who had partial or complete failure responding to initial bevacizumab or     ranibizumab treatment of 3-6 monthly intravitreal injections. The patients in the study     groups will receive 5 intravitreal injections of aflibercept 2mg/0.05ml at specific visits.     Aflibercept will be provided for total period of 24 weeks.   "
104458|NCT01918865|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of     ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral     antidiabetic drug/s.   "
104461|NCT01918826|"     The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases:     there is no curative treatment at present, on the other hand precautionary measures can be     taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the     literature and in our recent study (evaluation of the pain in the disease of CMT - Reference     center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important     varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the     pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous     neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought     back collateral effect, used at the same time in the chronic pain and acute since 1960, as     well for the neuropathic pains that musculo-scrawny. No study was realized this day on the     use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency     of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most     frequent painful location in our recent works.      The main objective will be to analyze the improvement of the pain of lower limbs, based on     the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.      The secondary objectives will be to estimate repercussions on the functional capacities (     ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global     impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic     Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and     Depression scale).   "
104462|NCT01918813|"     This study was designed to evaluate the effect of a targeted preoperative     Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction     (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk     population undergoing gastroenterological surgery. The primary endpoint was to investigate     whether the potentially high incidence of MRSA infections in patients with MRSA nasal     colonization before surgery can be prevented with a PCR-based strategy. The second endpoint     was to investigate the impact of acquisition of MRSA colonization after surgery on the     occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection is     prevented by a targeted screening strategy in preoperative MRSA carrier, and there is limited     effect in patients with postoperative MRSA acquisition.   "
104463|NCT01918800|"     The purpose of this study is to compare two different educational programs for people with     multiple sclerosis (MS), which is a common and often disabling disease of the central nervous     system. MS causes many symptoms including difficulty walking, loss of balance or muscle     coordination, fatigue, numbness and tingling and stiffness. The investigators want to     determine which program is better at helping improve quality of life and MS symptoms. Both     programs use material from the National Multiple Sclerosis Society (NMSS). Both programs     include 6 weekly 2-hour class sessions. Up to 600 participants will be enrolled total in 4 VA     sites, with about 150 at each site. There will be 10 study visits, all to occur within 11     months. These include 1 baseline visit, 6 two-hour class visits, and 3 follow-up data     collection visits. The participants in Portland will also participate in a final 12 month     followup visit. Participants will be randomly (by chance) assigned to be part of either group     education program. They will have a 1:1 or 50% chance of being in either program.   "
104464|NCT01918787|"     rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in     adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is     effective in improving social ability in adults with autistic spectrum disorder   "
104465|NCT01918774|"     In 2010, 11.5% of all Gulf War-II Veterans were unemployed; that figure rose to 15.2% in     January 2011 and continues to grow as the number of Veterans from recent wars increases     (United States Department of Labor, 2011; Seal et al., 2009). The prevalence of mental     illness among Veterans is also notable; estimates range from 31% (Seal et al., 2007) to     nearly 37% (Seal et al., 2009) for any psychiatric disorder, and over half of these Veterans     are diagnosed with more than one psychiatric condition (Seal et al., 2007). In addition,     empirical evidence suggests that some mental disorders are more prevalent in Veterans than in     the general population (Kessler et al., 2005). Linking unemployment and mental illness, a     recent study found that 65% of Veterans using VA healthcare were unemployed, and compared to     employed Veterans, the unemployed were more likely to have depression, bipolar disorder, post     traumatic stress disorder (PTSD), schizophrenia, or substance use disorders. Vocational     dysfunction was reported most often in disabled Veterans with schizophrenia, PTSD, and     substance use disorders (Zivin et al., 2011). Not surprisingly, this study also found that     unemployed Veterans had significantly lower income than employed persons. Similarly, a large     study focusing specifically on Veterans with PTSD concluded that vocational dysfunction is a     notable problem among this group, as they were significantly less likely to be employed after     participating in VA work programs compared with participants without the disorder (Resnick &     Rosenheck, 2008). Because most individuals with mental illness desire to work in regular     competitive employment (McQuilken et al., 2003), the nationwide problem of unemployment among     Veterans with mental illness is particularly troubling.      The VA is addressing this need by implementing supported employment (SE), a psychiatric     rehabilitation approach that provides individual vocational assistance to Veterans with     mental illness. While the SE model is empirically validated and SE programs have been shown     to achieve partial success in improving employment outcomes, a sizable proportion of     individuals, 40% or more, remain unemployed (Bond et al., 2008). A further challenge is job     retention; Veterans with mental illness who obtain jobs frequently struggle to maintain them     long-term. Even in the context of high quality, evidence-based vocational services, most     studies show only modest job retention of a few months (Bond et al., 2008), and consequently,     frequent job losses and inconsistent vocational functioning remain a substantial and unsolved     problem.      Rationale: Cognitive behavioral therapy (CBT) effectively reduces symptoms across a range of     psychiatric conditions (Butler et al., 2006; Wykes et al., 2008); however, its benefit to     functioning remains less well understood. Work functioning has received little empirical     attention in the CBT domain. Despite research evidence suggesting that maladaptive thoughts     about oneself and expectations about the ability to work interfere with work success (e.g.,     Hoffman et al., 2000; Kukla, Bonfils & Salyers, 2015; Kukla, McGuire, & Salyers, 2015), no     CBT programs have been developed specifically targeting vocational themes with the goal of     improving competitive work outcomes. Further, a recent paper outlined needed avenues of     future study in the SE domain; Drake and Bond (2011) state that cognitive strategies may be a     fruitful area to develop to help nonresponder consumers with mental illness who struggle     with vocational dysfunction despite high quality vocational assistance. The goal of the     current project is to address this gap and the serious problem of unemployment in Veterans     with mental illness by pilot testing the CBT for work success program (CBTw) and assessing     key employment outcomes before and after the intervention, and six months after conclusion of     the intervention.      Specific Aims:      Aim 1: Test the preliminary efficacy of the CBTw program on key Veteran employment and     psychosocial outcomes utilizing a pre/post design.      Aim 2: Further assess the feasibility of the program, including recruitment, retention rates,     and program participation rates.      Aim 3: Gauge effect sizes in preparation for a larger randomized controlled trial examining     the effectiveness of the CBT program in routine practice settings   "
104466|NCT01918761|"     To identify a dose of dacomitinib in combination with pemetrexed that is safe and tolerated     as determined by the incidence of DLTs (dose limiting toxicities).   "
104467|NCT01918748|"     Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke     patients have not reached their full potential when they are discharged from hospital. It is     proven that extra training opportunities lead to further improvement. To date, new training     possibilities, such as robotic techniques for rehabilitation, virtual reality training     systems and tele-rehabilitation are being developed to aid in the training of stroke     patients.      Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive     6-week technology-assisted training regime, featuring a robotics-based self-adapting arm     training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and     arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm)     muscle strength.      Study design: single arm prospective cohort study. Study population: 16 stroke patients in     the chronic phase after their stroke, aged >=18, diagnosed with a central paresis of the arm,     having low to moderate proximal (shoulder and arm) muscle strength.      Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or     challenges the patient to perform movements of the arm, thereby training motor control and     co-ordination of the affected arm. Also strength and endurance of arm muscle use may be     trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend     training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at     least half an hour to avoid (general) fatigue and overuse.      Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the     start of the intervention, each interspaced by 1 week to assess baseline stability or any     fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is     not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training.     Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling.     Secondary outcome measures are: motricity index, plate tapping task, active range of motion,     perceived strength and fatigue.   "
104468|NCT01918735|"     The primary objective of this study is to evaluate the safety and tolerability of single     ascending (increasing) and multiple doses of GWP42006 compared with placebo.   "
104469|NCT01918722|"     In order to investigate the time window of acute intracerebral hemorrhage(AICH) by Blood     Activating and Stasis Dispersing therapy and to verify traditional methods if it would     influence or enlarge the brain hematoma, test is made by random double-blind controlled.     Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the     therapy lasts two weeks, and the follow up should last three months. The main indexes are     mortality rate, disability rate and the brain hematoma situation. The review is made by the     reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.   "
104472|NCT01918683|"     This trial is designed to be the initial prospective pilot investigation of the effectiveness     of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation.     No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant     population have been performed. We propose the trial be conducted as a pilot clinical trial     with the goal of enrolling 40 patients into each arm   "
104814|NCT01914198|"     The investigators are proposing a study where the investigators would give a survey to the     parents of patients having a sleep study. The survey would contain questions relating to     symptoms of sleep apnea and then the investigators would correlate the parent answers to the     results of the sleep study.   "
104475|NCT01918644|"     This phase I trial studies the side effects and best dose of stereotactic body radiation     therapy when given together with capecitabine before surgery in treating patients with     pancreatic cancer that can be removed by surgery. Stereotactic body radiation therapy may be     able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used     in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving stereotactic     body radiation therapy and capecitabine before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.   "
104476|NCT01918631|"     Currently, five nucleos(t)ide analogs are approved for the treatment of chronic hepatitis B,     namely lamivudine, adefovir dipivoxil, telbivudine, entecavir (ETV) and tenofovir disoproxil     fumarate (TDF). ETV and TDF are recommended as first-line therapy by all regional guidelines     due to their high anti-viral potency and low risk of inducing resistance.      ETV monotherapy for chronic HBV infection is highly effective in both HBeAg-positive and     negative treatment-naïve patients. The cumulative probability of maintained virologic     suppression with undetectable HBV DNA at year 1, 2 and 3 were 76.5%, 83.0% and 88.3%     respectively.      TDF is another potent anti-viral treatment for chronic hepatitis B. Up to 72% and 87% of     HBeAg-positive and -negative patients achieved undetectable HBV DNA by week 144 of TDF     monotherapy. It is also effective in patients with prior exposure to other nucleo(s)tide     analogs. Previous studies demonstrated that TDF can be used as an effective rescue therapy in     lamivudine or adefovir-treated patients with incomplete virologic response.      However, the optimal treatment for patients with suboptimal response to ETV is uncertain.     With this background, we will conduct a randomized controlled trial to evaluate the efficacy     of TDF switch therapy in patients with incomplete virologic response to ETV treatment.   "
104477|NCT01918618|"     Recent experimental and clinical data suggest a benefit of levosimendan on the kidney     function. Therefore, this retrospective, single center, matched-pairs analysis aimed to     investigate whether administration of levosimendan was associated with improved renal     function in cardiac surgery patients.   "
104478|NCT01918605|"     The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal     product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.   "
104479|NCT01918592|"     Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack     accurate imaging technologies in clinical staging and estimation of response to neoadjuvant     chemotherapy as well as prognostic biomarkers.      In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer     prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also     prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response     to neoadjuvant chemotherapy.   "
104480|NCT01918579|"     Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can     reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence     of antibiotic abuse for community acute respiratory infection has been reported. This study     will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory     illness at primary healthcare stations reduces inappropriate antibiotic use safely.      The study will be conducted at ten district health care facilities in Hanoi, Viet Nam.     Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute     respiratory infection. Patients will be randomly allocated to the control or the intervention     arm. Participants in the control group will be treated according to routine care.     Participants in the intervention arm will have a CRP test, the results of which will be     available to the health care practitioner to contribute to their diagnosis and treatment     decisions.      All patients will be followed-up via telephone call after 14 days. The study will compare the     proportion of patients in each arm receiving any antibiotics within 2 weeks of study     enrollment.   "
104481|NCT01918566|"     Our objective is to investigate neuro-anatomical correlates of the regulation of energy     intake by means of functional MRI. Administration of glucose with and without lactisole and     exendin as well as fructose is followed by functional brain MRI, and findings are correlated     with serum GLP-1 levels as an endogenous satiety signal in humans.   "
104482|NCT01918553|"     Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised     countries. There are few epidemiological studies on the incidence of this disease. Studying     the incidence of AMD in an elderly French population and identifying the predisposing factors     is very important to allow a major advance in the epidemiological knowledge of AMD. This     study will contribute to the identification of the clinical, genetic and modifiable     parameters associated at the risk of developing AMD. This could result in means prevention as     well as in the identification of subjects as high risk of AMD   "
104536|NCT01917851|"     The purpose of the study is to define the precision, accuracy and variability of the NBM-200     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.   "
104483|NCT01918540|"     The study aims at comparing the effect of hollow or solid centralizer designs on the long     time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In     a prospective, controlled and randomized study comprising two groups of 30 patients/hips     each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In     completion general health questionnaires as well as hip specific scoring instruments will be     used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the     different centralizers will result in different migration patterns of the stems, which might     affect the risk for late aseptic loosening.   "
104484|NCT01918527|"     The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy +     operation with the standard treatment of locally advanced colon cancer, which is operation +     8 cycles of (adjuvant) chemotherapy.      Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the     operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.   "
104550|NCT01917669|"     The purpose of this research is to better understand how calcium and glucose may play a role     in people developing diabetes. By doing this study, the investigator hopes to learn whether     abnormal calcium and glucose responses in skin biopsies from healthy patients and patients     with Type 2 diabetes can identify and predict patients at greatest risk for later     complications.   "
104486|NCT01918501|"     Background: Multiple sclerosis (MS) is a complex and multifactorial neurological disease     characterized by infiltration of immune cells and progressive damage to myelin and axons.     Remyelination, the generation of new myelin in the adult nervous system, is an endogenous     repair mechanism that restores function of axons. Neurons require considerable energy for     their activities, including synaptic neurotransmission, and hence have significant numbers of     mitochondria. Unlike other cell types that are able to utilize glycolysis as an alternative     energy source, glycolysis in fully differentiated neurons is basically suppressed to maintain     their antioxidant status. This property makes neurons highly vulnerable to ATP deficiency,     and may be a factor in the susceptibility of neurons to cell death. Mitochondria provide     cellular energy by converting oxygen and nutrients into adenosine triphosphate (ATP); and     reflect local metabolic needs and via oxidative phosphorylation. Nervous tissues contain     about 70% lipids of their dry weight, and around 40% of these lipids are polyunsaturated     fatty acids (PUFAs).      Goal: Understanding the relationship between blood composition, mitochondria role and     clinical status.      Here, we will examine expression levels of different fatty acids in the blood and monitor     mitochondrial transmembrane potential as marker for the mitochondria general function.      Hypothesis: Remyelination efficiency in MS is likely mediated by many factors, besides     reducing inflammation. Remyelination may not be achieved correctly /sufficient in MS patients     due to nutrition low content causing mitochondrial dysfunction and/or due to fatty acid     molecules deficit unable to create a new myelin layer.   "
104487|NCT01918488|"     The purpose of the study is to determine whether a diuretic drug called amiloride is capable     of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients     with kidney disease. Our hypothesis states that amiloride is capable of reducing blood     pressure in these patients and thus decrease the cardiovascular risk associated with diabetic     kidney disease.   "
104488|NCT01918475|"     Carbetocin is a synthetic analogue of the hormone Oxytocin and is routinely used in obstetric     anesthesiology to control uterine bleeding after cesarean section. As an incidental finding,     women who received carbetocin had less pain after cesarean section than women who had     received Oxytocin. Carbetocin may therefore have an analgesic effect.      The present study examines this analgesic effect using different sensory tests, e.g.     pressure, heat, cold and electrical pain before and after administration of carbetocin in     healthy male volunteers. Any changes in these sensory tests might be indicative of an     analgesic property of carbetocin.   "
104489|NCT01918462|"     The purpose of this study is to investigate the production, effects and interactions of the     hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.   "
104490|NCT01918449|"     The objective of the study is to compare the results of a coordinated and interactive program     for the treatment, monitoring and control of patients with a moderate-severe diagnosis of     Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the     currently established situation.      Methodology: Equivalence randomized comparative study . It will include patients with     diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with     (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida     (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the     Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis     has been made and it was indicated that treatment with CPAP. Patients Will be carried out in     both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6     months. Primary outcomes: number of hours of use per day (according to the accountant of the     CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary     outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment.     It will be collected demographic ,clinics and anthropometric variables. At the end of     follow-up primary and secondary outcomes will be compared between two groups.   "
104500|NCT01918319|"     Children born to obese women are at risk of increased adiposity and later adverse metabolic     outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP     study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant     women were randomized to either lifestyle intervention or routine obstetric care. This     present study follows the children until 3 years of age. We have the hypothesis, that the     intervention during pregnancy results in a lower degree of adiposity and metabolic risk     factors in the offspring. Clinical examination is taking place at age 2.5-3 years including     anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring     metabolic markers.   "
104577|NCT01917318|"     The purpose of the study is to determine whether Iloperidone is effective in the treatment of     some symptoms in patients with PTSD, particularly difficulty falling or staying asleep,     trauma dreams and daytime irritability or outbursts.   "
104491|NCT01918436|"     Background:      TEAMS (Training Executive Attention and Motor Skills) is a non-pharmacological,     neurocognitive intervention program targeted preschool children with ADHD developed by     Professor Jeffrey Halperin, and his team from New York University. The uniqueness of this     program lies in the concept, based on stimulating neurocognitive growth through focused     physical activity and play (Halperin et al.; 2011, 2012, in press).      Teams hypotheses:      TEAMS is based on the notions that:        1. The behavioural manifestations of ADHD are the result of deficient neural networks that          affect a wide array of neurocognitive and behavioural processes which are not          necessarily identical in all children with the disorder.        2. Neurodevelopment is sensitive to and can be positively affected by appropriate          environmental influences.        3. Effective environmental stimulation will be best achieved within a social context.        4. The engagement of the child in the core activities of the treatment must be          intrinsically rewarding (i.e., fun) in order to facilitate compliance of the          intervention.      The initial research by Halperin et al. (2012)indicated significant improvement in ADHD     severity from pre- to post-treatment, which also persisted 3 months later.      Objective: The aim of this study is, through a randomized controlled trial (RCT), to validate     the TEAMS treatment program in a clinical setting in Denmark.      Method: Pre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as     primary diagnosis are offered participation in the RCT study of the TEAMS program. The     control groups receive the standard treatment program, outlined by the clinical guidelines of     Region Zealand. The intervention groups participate in eight weekly group sessions consisting     of separate parent- and children's groups.      In the child group the children are introduced to games that are designed to enhance     inhibitory control, working memory, attention, visuospatial abilities, planning, and motor     skills. The parent group consists of psychoeducation and instructions in how to encourage     playing these games with their children and how to support the child's development.   "
104551|NCT01917656|"     This trial is conducted in Africa and Asia. The aim of the trial is to investigate the     efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with     metformin during Ramadan in subjects with type 2 diabetes (T2DM).   "
104492|NCT01918423|"     Children born to obese women are at risk of increased adiposity and later adverse metabolic     outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP     study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant     women were randomized to either lifestyle intervention or routine obstetric care. This     present study follows the children until 3 years of age. We have the hypothesis, that the     intervention during pregnancy results in a lower degree of adiposity and metabolic risk     factors in the offspring. Clinical examination is taking place at age 2.5-3 years including     anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring     metabolic markers.In addition, we have included an extra control group of children born to     normal weight women, who were not part of a lifestyle intervention program during pregnancy.     We have the hypothesis that the children of the normal weight women have a better metabolic     profile than the children born to the obese women.   "
104493|NCT01918410|"     Contact lens induced dry eyes leads to lens intolerance and discontinuation. Incidence of dry     eye in contact lens wearer is significantly higher in Asian population compared to other     ethnic group considering Asian has lower tear break up time. Disruptions of tear integrity in     contact lens wearer will further exacerbate the condition. Factors for successful contact     lens fitting derive from the biocompatibility of lens material, lens design and stability of     tear film in front of the contact lens. This study aim to investigate the efficacy of a novel     daily disposable contact lens with zwitterionic material that contains alginic acid which act     as a moisturizing agent. The improved lens material may likely improve the comfort and treat     symptomatic wearers.   "
104494|NCT01918397|"     Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around     the world. This type of tuberculosis is very difficult to treat, and many patients die from     it. Drugs of the fluoroquinolone class are very important for treating MDR-TB, but the best     dose of one of the most effective fluoroquinolones, levofloxacin, is not known. This     application proposes a study to determine the best dose of levofloxacin to use in treating     MDR-TB. 120 patients will receive their usual treatment, plus levofloxacin at one of four     doses. The study will be performed in Peru and in South Africa, where MDR-TB is common.   "
104495|NCT01918384|"     Duchenne Muscular Dystrophy (DMD) is inherited neuromuscular disorders due to mutation in the     gene that encodes critical muscle protein called dystrophin. Currently, there is no effective     treatment option for the disease. A pharmacological approach by promoting mRNA translation     regardless of the presence of premature stop codons by nonsense mutation, called the     readthrough strategy, has been developing recently for DMD with nonsense mutation. NPC-14 is     a candidate compound for the readthrough strategy, since effective readthrough activities     were demonstrated in nonclinical studies. This study is a phase II study designed to assess     safety, tolerability, and efficacy of NPC-14 in ambulant DMD patients with nonsense mutation     that were confirmed by whole genome analysis. These goals will be accomplished by monitoring     adverse events by physical examination, cardiac, pulmonary, auditory, balance, and laboratory     tests as safety endpoints, and dystrophin expression in muscle biopsy as primary efficacy     endpoint, muscle function (NSAA, timed test, muscle strength (QMT, MMT) , dairy activities by     lifecorder), and biomarkers as secondary efficacy endpoints. The study is a randomized,     double blind, placebo-controlled study in 21 DMD patients. After screening, eligible patients     are allocated dynamically to weekly NPC-14 or a placebo (saline) in a 2:1 ratio and will     receive study drugs for 36 weeks.   "
104496|NCT01918371|"     This retrospective data review study will evaluate anti-VEGF injections for retinal vein     occlusion (RVO) or diabetic macular edema (DME).   "
104497|NCT01918358|"     To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab     160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and     Crestor® (Rosuvastatin) 20 mg in healthy male volunteers   "
104498|NCT01918345|"     Mothers with previous gestational diabetes mellitus (GDM) represent a population at higher     risk of future Type 2 diabetes mellitus (T2DM), which is preventable through lifestyle     modification. Yet, no formal prevention programs exist for this population. The postpartum     period is a particularly vulnerable period for weight gain and unhealthy lifestyle in new     mothers due to their competing demands of childcare and breastfeeding. This important time     period may thus represent a 'window of opportunity' for women with previous GDM, whereby     interventions to improve their lifestyle can be offered. Eligible women will be recruited     during pregnancy from four hospitals and invited to participate in a home-based lifestyle     intervention program starting from three to six months postpartum. This pilot study will     investigate the feasibility and effectiveness of a physical activity and diet intervention.     It will also explore the relationship between behaviour change and metabolic markers of T2DM     in this high-risk population. Investigators hypothesize that the ADAPT-M program will be     feasible and will be associated with an improvement in metabolic T2DM markers, as well as a     high rate of satisfaction, adherence, and effectiveness.   "
105226|NCT01908777|"     The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in     patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous     transplantation.   "
104501|NCT01918306|"     This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K     inhibitor GDC-0941 when given with the chemotherapy cisplatin. This study will also examine     how well the combination of GDC-0941 and cisplatin work in treating patients with androgen     receptor negative triple negative metastatic breast cancer. Patients will be randomized to     receive cisplatin alone or cisplatin with GDC-0941 in the phase II portion. Those receiving     cisplatin alone can receive GDC-0941 upon progression of their disease. Cisplatin is a     chemotherapy which has been shown to be effective in treating triple negative breast cancer.     Preclinical studies show that adding a PI3K inhibitor such as GDC-0941 to cisplatin may be a     more effective treatment for breast cancer.   "
104502|NCT01918293|"     Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to     inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough,     wheezing and severe life-threatening attack and lower quality of life. In addition, it make     large amount of socioeconomic loss as about 3.7 billion US dollars.   "
104552|NCT01917643|"     This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC)     and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.   "
104503|NCT01918280|"     Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn     males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly     non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%)     have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of     sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some     pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since     1997, more than one hundred births are described.      As some studies shown a decrease of successful sperm retrieval with the increasing of age, we     plan to compare the potential of sperm retrieval between two groups adult (23-55 years) and     young after the onset of puberty (15-22 years). The study will be performed by searching     spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if     the azoospermia is confirmed on semen analyses.   "
104504|NCT01918267|"     This non-interventional, observational, open-label multi-center follow-up study of patients     from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of     starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in     patients early in the disease followed by treatment according to standard of care in routine     clinical practice in a three year follow-up, independently of what treatment the patient will     be receiving.   "
104505|NCT01918254|"     This multicenter, open-label dose-escalation study with an extension phase will evaluate the     safety and pharmacokinetics of RO5479599 in combination with pertuzumab and paclitaxel in     participants with metastatic breast cancer expressing HER3 and HER2 protein. Cohorts of     participants will receive escalating doses of RO5479599 intravenously (IV) every three weeks     (Q3W) in combination with pertuzumab 840 milligrams (mg) IV initial dose followed by 420 mg     IV Q3W and paclitaxel 80 milligrams per square meter (mg/m^2) IV weekly. After completion of     dose-limiting toxicity period (21 days), the study will be conducted in two extension phase     cohorts: Cohort 1 and Cohort 2. Enrollment in Extension Phase Cohort 2 will occur only upon     completion of Extension Phase Cohort 1. Anticipated time on study treatment is until disease     progression or unacceptable toxicity occurs.   "
104506|NCT01918241|"     This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a     single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.   "
104507|NCT01918228|"     RCT study of the effect of an educational-based intervention on low back pain-related     outcomes concerning beliefs and behaviour.   "
104508|NCT01918215|"     Contemporary heart failure (HF) guidelines recommend insertion of a primary prevention     implantable defibrillator (ICD) in patients with left ventricular ejection fraction less than     35% (LVEF < 35%) on maximally tolerated medical therapy. Nevertheless, there are a     substantial number of HF patients who have LVEF>35% and hence do not qualify for ICD, who     succumb to sudden cardiac death (SCD). At present our tools to reliably risk stratify these     patients with mild-moderate systolic dysfunction (LVEF 36-50%) are poor. It is likely that     these patients have ventricular scar and/or replacement fibrosis as a substrate for their     malignant arrhythmia. Cardiovascular magnetic resonance imaging (CMR) can reliably identify     and quantify both ventricular scar (seen in Ischaemic cardiomyopathy, ICM) and replacement     myocardial fibrosis (seen in Non-Ischemic Cardiomyopathy, NICM).      Methods/Design: A multi-centre randomised controlled trial in which 428 patients with     mild-moderate left-ventricular systolic dysfunction (either ICM or NICM) and ventricular     scar/fibrosis on cardiovascular magnetic resonance are randomized to either ICD or     implantable loop recorder (ILR) insertion and are followed up for 3 years.      Potentially eligible patients will have a screening CMR and will be enrolled into the device     arm of study based on the presence of any ventricular scar/fibrosis (CMR +). Patients who do     not have ventricular scar/fibrosis will be followed up in an observational registry, and will     not be randomised.      In both the device and registry arms, we aim to enrol 700 patients in Australia and 355 in     Europe.      The primary hypothesis is that among patients with mild-moderate left ventricular systolic     dysfunction, a routine CMR guided management strategy of ICD insertion is superior to a     conservative strategy of standard care.   "
104509|NCT01918202|"     This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography     after a single dose of PF-02545920 in Healthy male volunteers.   "
104510|NCT01918189|"     The purpose of the proposed project is to develop and test how well an internet-based     behavioral pain self-management program, the Pain EASE program, can be used for treating low     back pain in Veterans. Veterans' experiences with usability and satisfaction with the Pain     EASE program will also be examined. Behavioral interventions such as exercise and cognitive     behavior therapy are known to be effective for low back pain but are often not readily     available or easily accessed. Veterans will be able to access the Pain EASE program via their     computer with an internet connection, which will increase access to this type of treatment.     Study participants will receive 10 weeks of access to the Pain EASE program, which will teach     them pain coping skills to manage their low back pain. The primary outcome is pain-related     functional interference.   "
104511|NCT01918176|"     Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of     Palbociclib in absence and presence of prior administration of proton pump inhibitor     Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of     Rabeprazole might affect the absorption process of Palbociclib.   "
104546|NCT01917721|"     Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and     blood vessels including the coronary arteries of the heart. Despite the currently available     therapy, about one third of children develop enlargement of the coronary arteries that can     lead to serious complications such as coronary artery stenosis, heart attack and even death.      Kawasaki disease is the most common heart disease in children in the USA and it is especially     common among the children of Hawaii. Every year, 50-90 children are diagnosed with KD in     Hawaii and unfortunately there is no medication available to successfully prevent coronary     artery damage in a subset of cases.      During the first few weeks of the illness, cells of the immune system attack the coronary     arteries and release a special substance (MMP) that is responsible for the coronary artery     enlargement. There is a common antibiotic, doxycycline that can specifically block the action     of this special substance (MMP). Research done on animals with KD showed that doxycycline was     able to block this special substance and prevent enlargement of coronary arteries. Research     in adults with enlargement of the main artery in their abdomen also showed that doxycycline     may improve the outcome. Based on these studies doxycycline may be a promising therapy for     children with KD, who develop enlargement of the coronary arteries.      The investigators' proposed research study will assess the usefulness of doxycycline in     preventing the progressive enlargement of coronary arteries in children with KD. The     investigators plan to perform a small (pilot) study to evaluate how good is doxycycline in     preventing coronary artery enlargement. The investigators will treat 25 children with KD and     enlarged coronary arteries for two weeks with doxycycline and assess the change in coronary     arteries as well as the blood levels of the special substance (MMP). If doxycycline proves to     be beneficial in this small study, the investigators are going to design a large research     study involving multiple institutions on Hawaii and the mainland and will recruit more     children to be certain about the value of the proposed treatment. The investigators' proposal     may change the treatment protocol of KD and could present a possible treatment for children     with enlarged coronary arteries preventing potentially devastating consequences.   "
104514|NCT01918137|"     The deep fried chocolate bar is a snack that the international community strongly associates     with Scotland. It has previously been cited as being a symbol of all that is wrong with the     high-fat, high-sugar Scottish diet. Despite the snack's reputation, no medical research has     been performed to examine the effects of consuming a deep fried chocolate bar on the human     body.      In contrast to the deep fried chocolate bar, porridge has been shown to reduce the risk of     cardiovascular disease, but its effect on cerebral blood flow has yet to be directly     assessed.      This study will focus on the potential (patho)physiological cerebrovascular effects of the     deep fried chocolate bar and porridge. The research question to be addressed in this study is     Does eating a deep fried chocolate bar or bowl of porridge induce changes in cerebral blood     flow and cereborvascular reactivity in healthy adults?      To assess the acute effects on eating either food on blood flow through the largest artery in     the brain, the investigators will give healthy volunteers one regular-sized deep-fried     chocolate bar or a bowl of porridge. Blood flow through the largest artery in the brain will     be assessed using simple ultrasounds tests. The investigators aim to recruit 24 volunterrs     who will visit twice, consuming a different food on each visit.   "
104515|NCT01918124|"     This phase II clinical trial was designed to assess the feasibility, safety, toxicity,     recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant     radiation for patients with high-risk endometrial cancer.   "
104516|NCT01918111|"     1. (RENEWAL-EXERCISE trial) The investigators hypothesize that the increased sympathetic          nervous system activation that is associated with resistant hypertension is a major          contributor in the pathogenesis of exercise diastolic dysfunction and that modulation of          the sympathetic nervous system activity with radiofrequency ablation of the renal artery          sympathetic nerve fibers delivered via a treatment catheter, will have a significant          effect on the diastolic function that is beyond BP-lowering effect.        2. (RENEWAL-REGRESSION trial) The major cause of mortality and morbidity in hypertension is          atherosclerotic cardiovascular disease. the significant decrease in the sympathetic          nervous system activation after renal sympathetic denervation will contribute to          regression over and beyond it's effect of blood pressure reduction.        3. (RENEWAL-PREDICT trial) No data exists regarding the tests or methods predicting the          successful renal denervation causing the effective reduction of BP. For these, the          investigators sought to perform the new tests such as adenosine infusion test during          procedure and skin sympathetic activity measurement before and immediate post-procedure          (detailed explanation provided in section of Methods) and then evaluate the association          between these tests and reduction of BP following procedures.   "
104517|NCT01918098|"     To determine the improvement in symptoms of constipation in subjects receiving treatment with     oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release     tablets (OXY) based on the Bowel Function Index (BFI)   "
104518|NCT01918085|"     The aim of the study is to investigate the correlation in peel force when peeling off a     standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin     compared to pre-stripped healthy abdominal skin in colostomists.   "
104519|NCT01918072|"     VA community-based outpatient clinics (CBOCs) typically serve only a small number of women     Veterans, and generally do not have the women's health care resources that are available in     larger settings. Women Veterans using these sites for primary care must sometimes travel to     other sites to receive women's health care. That can create travel burdens, reduce continuity     of care, and negatively affect patient outcomes. To address this, VA is implementing a     clinical operations innovation that supports women's primary care providers with a     technology-based intervention that combines interactive communication with women's health     specialists and ongoing education. This research study is evaluating the implementation and     effects of this women's healthcare delivery innovation. Findings from this research will     inform VA women's health clinical practice and education, and will advance science in     delivering technology-supported non-face-to-face care that is applicable to other clinical     conditions and patient populations.   "
104520|NCT01918059|"     This project is a randomized, controlled trial investigating wound cosmetic appearance after     repair of traumatic lid lacerations with three different approaches to skin closure:     absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken at     two intervals after repair and later blindly assessed using standard cosmetic assessment     scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in     across all three treatment arms.   "
104521|NCT01918046|"     This is a single-center, prospective sample collection study. Samples will be used to     establish the performance characteristics of myo-inositol oxygenase (MIOX) as an aid in the     early diagnosis of acute renal injury (AKI) following cardiac surgery.   "
104522|NCT01918033|"     This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese     participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine     is superior to placebo after 2 weeks of treatment with regard to change from baseline in     Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.   "
104523|NCT01918020|"     Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with     the goal of improving the health and wellbeing of low income families. University of     Minnesota Extension every year offers nearly 4000 educational events, serving approximately     70,000 Minnesotans through the program. Extension is conducting an impact study to determine     program effectiveness and assess sustained changes of participants and their families that     can be directly attributed to programming on a larger and methodically sound scale.   "
104534|NCT01917877|"     Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced     pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not     only compromise cancer treatment, but also influence patient's life qualities and even death.     there are no specific treatment modalities for this treatment-induced complication.     Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and     pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients     will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by     Dexamethasone （10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone.     The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before     treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30     cases.   "
104524|NCT01918007|"     Obstructive sleep-disordered breathing (SDB) in childhood is a disorder of breathing during     sleep characterized by intermittent upper airway obstruction. Snoring, labored breathing and     apneas reported by the parents are the most frequent symptoms.Obstructive SDB can result from     many different abnormalities including large adenoids and tonsils or obesity.      Intermittent upper airway obstruction during sleep is accompanied by low oxygen or high     carbon dioxide in the blood and arousals from sleep. If obstructive SDB is not treated,     complications may develop such as: i) enuresis; ii) delay in somatic growth rate; iii)     central nervous system morbidity (e.g. hyperactivity and learning difficulties); and iv)     elevated blood pressure.      Overnight polysomnography (PSG) is considered the gold-standard method for defining severity     of obstructive SDB and subgroups of children with snoring who should be treated. However, PSG     is a labor-intensive, time-consuming and expensive diagnostic method, which is not available     in many community settings. Thus, there is an urgent need for developing easy-to-use and     low-cost diagnostic methods which can be used to determine severity of obstructive SDB and     define subgroups of children with snoring and large adenoids and tonsils who will benefit     from adenotonsillectomy (AT).      Pulse oximetry is a widely available, non-invasive method which allows continuous monitoring     of oxygen transport by hemoglobin. Episodes of upper airway obstruction are frequently     accompanied by reductions in the hemoglobin oxygen transport (oxygen desaturation of     hemoglobin).The hypothesis of this research project is that subgroups of children with     snoring and adenotonsillar hypertrophy and certain abnormalities in oxygenation detected by     nocturnal pulse oximetry will benefit from AT in a community setting.   "
104525|NCT01917994|"     Retention in care and virologic suppression are the key final steps of the HIV treatment     cascade. Poor or intermittent retention has been associated with later initiation of     antiretroviral therapy, virologic failure, and death. Regular HIV care has also been     associated with a decrease in HIV transmission risk behavior. Despite the proven health and     prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the     United States are estimated to meet current retention in care standards and even fewer - only     about 25% - are estimated to be virologically suppressed.      The Behavioral Model for Vulnerable Populations provides a useful framework for understanding     broad areas that may impact adherence to care and treatment. Individual-level domains include     vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and     need (e.g., co-morbidities) factors, and structural domains include, for example, features or     the clinic and the provider-patient relationship.      Short message service (SMS) technology represents a new and exciting tool to help retain     HIV-infected patients in care and treatment. SMS interventions have been deployed     successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan     Africa, where two randomized trials have showed clear benefits. A pilot study conducted in     our clinic suggests that use of SMS messages to promote adherence to care and treatment in     the urban HIV-infected poor is both feasible and acceptable.      The investigators believe that combining SMS technology with content-specific messages     designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can     improve retention in care and virologic suppression for an urban public hospital population     living with HIV, thus the investigators propose the following specific aims.      Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves     virologic suppression [primary outcome] and retention in care [secondary outcome] for a     vulnerable urban HIV-infected population through a randomized trial of this technology     compared to SMS appointment reminders alone. Retention in care will also be analyzed as a     mediator of virologic suppression. Exploratory outcomes include time to virologic     suppression, sustained virologic suppression, emergency department utilization and     antiretroviral adherence, as well as levels of depression, positive affect, social support     and empowerment.      Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically     on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of     patient use of this technology, and; 3) the preferred frequency and content of intervention     messages.      Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.   "
104526|NCT01917981|"     This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm     Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more     than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for     arrhythmia detection.   "
104527|NCT01917968|"     The purpose of this study is to compare transvaginal mesh repair to traditional native tissue     repair in women surgically treated for anterior and/or apical pelvic organ prolapse.   "
104528|NCT01917955|"     The purpose of this prospective single-center trial is to compare the safety and diagnostic     value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal     echocardiography in patients with acute ischemic stroke.   "
104529|NCT01917942|"     This is a two arm randomised phase III trial which will evaluate prospectively the benefits     of humidification in patients receiving radiotherapy / chemoradiation for head and neck     cancer. The intent of humidification is to moisturise the mucosa. The rationale for the use     of humidification with radiotherapy can be considered an extension of the general principle     of moist wound care in wound management.   "
104530|NCT01917929|"     This study is a prospective, open-label, post-market, non-randomized, multi-center clinical     evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a     cementless application in a consecutive series of patients who meet the eligibility criteria.     The success rate of the Secur-Fit Advanced femoral stem, defined as absence of stem revision     for aseptic loosening or femoral fracture, is expected to be no worse than 99% at 5 years     postoperative with a non-inferiority margin of 2.5%.   "
104531|NCT01917916|"     Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising     doses in healthy Asian male volunteers.   "
104532|NCT01917903|"     This study will evaluate gait when individuals with Parkinson's disease (PD) are walking     while talking to see how walking changes when challenged to perform a functional cognitive     task simultaneously. By looking at walking alone and walking with varying cognitive loads the     investigators will be able to determine motor and cognitive factors vulnerable to     interference in PD. Each is important to understand so that training can address components     of walking that become impaired when someone is distracted by a common cognitive task and so     that the intensity of treatment matches the level of task difficulty. Using this initial     data, the investigators will establish a protocol to improve walking taking into account the     unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with     memory and attention. The investigators will evaluate the potential for this treatment to     improve walking and improve or maintain cognitive abilities necessary to multitask.   "
104533|NCT01917890|"     Prostate cancer is the second most incident cancer among male population worldwide. Radiation     therapy by itself or along with surgery and chemotherapy are the main treatments for prostate     cancer however prostate cancer cells are only modestly responsive or even unresponsive to the     cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed     radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in     this area and it is not yet known whether radiation therapy is more effective with or without     curcumin supplements in treating patients with prostate cancer.   "
138882|NCT01466868|"     The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in     patients with relapsed or refractory diffuse large B cell lymphoma.   "
104537|NCT01917838|"     The goal of this two-year R34 treatment development grant is to develop a mobile health     (mHealth) application that will both advance theory in and clinical practice of homework (HW)     implementation.      HW can be described as between-session exercises where the client practices specific skills     learned within-session in order to promote skill acquisition, which ultimately leads to     improved acute- as well as longer-term therapeutic benefits on targeted outcomes,     generalization of treatment effects and maintenance of treatment gains. Despite data     demonstrating that HW is critical to achieving maximal benefits from evidence-based     treatments, very little theory-driven approaches have been conducted focusing on improving     the HW process. Through utilizing self-determination theory as a guiding framework and     integrating principles from the field of gamification and goal-setting, the aim is to     develop a two-component mHealth HW application (My MFG).      The first component focuses on delivering HW via a highly engaging, multiplayer, interactive,     cooperative, and skill-building game platform aimed at improving the Design and Do     process of HW. The second component focuses on targeting factors putatively related to poor     HW implementation within the Do process.      The process of the development of My MFG will be guided by the clinic and community     development model and iterative software development process to maximize the feasibility and     sustainability of My MFG within practice settings often characterized by limited resources.     Findings from this study have broad implications for evidence-based treatments for youth and     adult mental health disorders that emphasize HW as the link between treatment and     improvements in targeted outcomes.   "
104538|NCT01917825|"     The primary objectives of this clinical trial are to investigate the pharmacokinetics and     safety of MDT-15 pellets in escalating sequential doses administered to different cohorts.     Preliminary efficacy data will also be collected for assessment.   "
104539|NCT01917812|"     Despite their importance, health-related behaviors are hard to change. Among behaviors,     physical activity is associated with protection from multiple diseases. People who are     physically active have lower risk for heart disease, stroke, type 2 diabetes, depression, and     some cancers with associated dose-dependent reductions in cardiovascular and all-cause     mortality. However, most US adults do not meet CDC physical activity guidelines. Sedentary     work behavior in industrialized nations is likely a contributor to this problem.      Current low-technology strategies for encouraging lifestyle change are disappointingly     ineffective and are highly resource intensive. Systematic reviews of the literature show     mixed evidence for using activity trackers (i.e., pedometers) and a limited body of evidence     for text messaging in preventive health care. However, prior studies have not integrated     digital activity tracking with mobile phone text messaging feedback.      Given 91% of adults in the United States now use a mobile phone, and 56% a smartphone, this     represents a potentially widely applicable avenue for therapeutic intervention. There is     growing interest in leveraging mobile health (mHealth) technologies to improve health     behaviors in the general population. The investigators propose to conduct a blinded,     randomized mHealth trial of digital activity tracking and smart texting to promote physical     activity.   "
104540|NCT01917799|"     Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in     patients with a history of recurrent miscarriages.   "
104541|NCT01917786|"     Various medications used in anesthesia have been implicated in the prolongation of QT     interval. Recently, there has been an increase in the use of dexmedetomidine in patients     presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties.     It has several desirable properties including minimal respiratory side effects as well as the     ability to decrease intraoperative and postoperative analgesic requirements. In many of the     patients who present for routine surgical procedures, dexmedetomidine is a common component     of their anesthetic care. This is a study to assess the effects of dexmedetomidine on the QT     interval in children presenting for surgery.   "
104542|NCT01917773|"     The research study is designed to test how a medication called octreotide affects the     motility (contraction or squeezing) of the colon (large intestine). Investigators are     investigating whether octreotide can increase contraction and movement in the colon.   "
104543|NCT01917760|"     The purpose of this study is to determine upon administering GABA orally to a person how it     is absorbed, distributed, as well as the drug's pharmacological effects on the body such as     glucose levels, serum C-peptide and/or insulin levels (referred to as     pharmacokinetics/pharmacodynamics). We will conduct experiments in normal subjects to address     these questions.   "
104544|NCT01917747|"     Hearing loss is the most common sensory congenital disorder and this condition is diagnosable     and treatable. Children that are born with hearing loss have to undergo several hearing tests     to diagnose the condition and many families are delayed in receiving this testing or never     obtain the needed testing. This research employs a new method for helping children with     hearing loss receive timely care by using a patient navigator, who is someone who teaches and     provides emotional/social support for the families of these children. The hypothesis of this     study is that a patient navigator will hasten the timing of pediatric audiological testing,     improve compliance with scheduled appointments, and expand parental knowledge of pediatric     hearing loss.   "
104545|NCT01917734|"     The purpose of this study is to assesses the effectiveness of an integrated model for the     management of severe acute malnutrition (IM-SAM) in India comprising facility- and     community-based care and using locally-adapted protocols   "
104578|NCT01917305|"     The concept of platform-switching has been introduced to implant dentistry based on clinical     observations of reduced periimplant crestal bone loss. However, published available data are     controversial and most studies are limited to 12 months. The aim of the present RCT was to     test the hypothesis that platform-switching has a positive impact on crestal bone level     changes after 3 years.   "
104579|NCT01917292|"     The purpose of this study is to determine the effect of periodontal intervention on vascular     dysfunction among Chinese prehypertensive adults with moderate to severe periodontal disease.   "
104580|NCT01917279|"     It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with     Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line     Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast     cancer(mBC).   "
125930|NCT01636739|"     This study aims to determine the incidence of intussusceptions (IS) (including suspected     cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in     Japan.   "
104556|NCT01917591|"     The objective is to determine, if healing of punch biopsy wounds treated with the fish skin     derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig     intestines derived Oasis Sheet wound dressing. Secondary endpoints are: Incidence of     erythema, Pain, Infection, Quantitative measurements of autoantibodies at baseline and 4     weeks after start of treatment   "
104557|NCT01917578|"     The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC     has been associated with significantly higher ipsilateral breast tumor recurrences.The     accuracy of breast tumor excision in BCS can dramatically reduce IBTR.The main reseason of     IBTR might be the uncertain shrinkage modes of the breast cancer after NAC.This clinical     trial is firstly carried out to make clear the shrinkage modes of the primary tumor after 3     cycles and whole cycles of NAC,respectively,with whole-mount serial section(WMSS) and     three-dimensional(3D) pathological reconstruction of the residual tumor.The second objective     is to investigate the predictive value of 3D MRI reconstruction for the shrinkage modes of     the primary tumor after NAC.   "
104558|NCT01917565|"     The investigators hypothesize that when used by experienced anesthesiologists, Airtraq     laryngoscope will increase the first-attempt success rate with shorter intubation times and     more stable hemodynamic parameters.   "
104559|NCT01917552|"     multi-center, prospective, randomized, open-label phase III   "
104560|NCT01917539|"     Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing     symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian     gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). The     uses of PLT are for treatment of rosacea, hair removal, pigmented lesions, and skin     telangiectasias. The risks include the potential for transient sunburn-like sensations (i.e.     redness, burning sensation) and particularly if not used properly, the potential to cause     burns, blistering, scarring, and pigmentary changes.   "
104561|NCT01917526|"     After general anesthesia, there are the risks for airway obstruction, hypoventilation,     atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement     in PACU seems necessary.      This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula     at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2     methods can equally provide effective oxygen supplement to prevent anesthesia-related     hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more     comfortable to patient.   "
104562|NCT01917513|"     The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition     colonoscopy with that of standard high definition colonoscopy   "
104581|NCT01917266|"     The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in     subjects with concordant versus discordant left ventricular (LV) lead position as compared to     the site of latest mechanical activation.   "
125931|NCT01636726|"     The studies described in this protocol are all performed within the framework of PROTECT     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work     Package 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate     methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE)     studies applicable to different safety issues and using different data sources. To achieve     this, results from PE studies on five key adverse events (AEs) performed in different     databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the     studies in this protocol and not on the clinical consequences of the association under     investigation .      Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic airway     diseases in the western world. For both, a stepwise treatment to reduce symptoms, improve     lung function, and prevent risk of exacerbation is recommended using several drug classes     according to guidelines published by e.g. the Global Initiative for Asthma [GINA guideline]     and the Global Initiative for Chronic Obstructive Lung Disease [GOLD guideline],     respectively. Beta-2-adrenoceptor agonists (B2A) are therapeutic mainstays in treating asthma     and COPD due to their bronchodilative effects mediated by B2A. This drug class consists of     two types of drugs: short acting B2A (SABA) which are used as a reliever medication and long     acting B2A (LABA) which are used as maintenance / controller medication. Formoterol and     salmeterol are the most frequently used LABA compounds with a half-life between 5-15 hrs and     therefore, these compounds most commonly have labelled indications for use twice a day. .      Focussing on cardiac side effects of B2A one must consider that drugs with an opposite     mechanism of action (beta-adrenoceptor-antagonists) have well-known cardio protective effects     and are widely used in patients suffering from e.g. ischemic heart disease, hypertension and     acute myocardial infarction (AMI)). Conversely, stimulation of cardiac beta-adrenoceptors as     done by B2A may have deleterious cardiovascular effects particularly in patients with cardiac     risk factors. And in fact, tachycardia and arrhythmias are well-known side effects of B2A     confirming a cardiac influence of these drugs particularly after oral therapy (due to a high     systemic exposure) as stated in the respective summary of product characteristics (SPCs),     e.g. clenbuterol (Spiropent(R)). Obviously, inhaled drugs cause much smaller systemic     exposure but cardiac side effects (e.g. arrhythmias, tachycardia) are also described in the     respective SPCs (e.g. formoterol [Foradil(R)). Furthermore, cardiac side were also reported     after exposure with inhaled MA (e.g. ipratropium [Atrovent(R)].      Several observational studies have been performed on the association between the usage of     inhaled B2A and the occurrence of AMI. However, these studies have produced conflicting     results. Reasons for this variation are numerous, e.g. small number of events (AMI) leading     to poor precision of risk estimate, potential misclassification of potential cardiac events     versus airway-related events due to similar clinical complaints, differences in populations     of drug users, measurement of drug exposure, and background risk of AMI. Additionally, a     consensus document was released in 2000, redefining AMI.      To make comparing results possible, this protocol gives guidelines for conducting studies in     the same way in five databases and across 3 designs (cohort, nested case-control,     case-cross-over) on the association between inhaled LABA use and AMI. The main focus is to     evaluate the impact of study design, population and database characteristics on the     association between inhaled LABA and AMI.      Data will be collected from the following databases: The Health Improvement Network (THIN),     the General Practice Research Database (GPRD), the Dutch Mondriaan project, Base de Datos     para la Investigación Farmacoepidemiológica en Atencion Primaria (BIFAP), the National     Databases of Denmark, and the Bavarian statutory health insurance physicians' association     database.   "
125932|NCT01636713|"     This is a 24-week, phase III multicenter, randomized, double-blind, placebo-controlled,     parallel-group study. The study will have 9 scheduled visits and a telephone contact     Follow-up visit one week following the end of study treatment.      The study primary endpoint is      -Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169 Trough FEV1     on Treatment Day 169 is defined as the mean of the FEV1 values obtained 23 and 24 hours after     dosing on Treatment Day 168 (i.e. at the Week 24 visit).      Secondary endpoints are;        -  Mean TDI focal score at Week 24        -  Weighted mean clinic visit FEV1 over 0 to 6 hours post-dose at Visit 2 (Day 1)      Eligible subjects will be randomised to GSK573719/GW642444 125/25mcg, GSK573719/GW642444     62.5/25mcg and placebo treatment groups in a 1:1:1 ratio such that of the planned 573 total     number of randomised subjects, approximately 191 subjects will be randomised to each active     treatment group and 191 subjects will be randomised to placebo. All treatments will be     administered once daily in the morning by inhalation using a Novel Dry Powder Inhaler (NDPI).      There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who     meet the eligibility criteria at Screening (Visit.1) will complete a 7 to 14 day Run-In     period followed by a 24-week Treatment period. Clinic visits will be at screening,     Randomisation (Day1), Day2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after     the Week 24 Visit (also referred as Treatment Day 169). A Follow-Up contact for adverse event     assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early     Withdrawal Visit. The total duration of subject participation, including Follow-up will be     approximately 27 weeks. All subjects will be provided with albuterol/salbutamol for use on an     as-needed basis throughout the Run-In and Study Treatment Periods.      At screening, pre-bronchodilator spirometry will be performed followed by     post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/FVC     values will be used to determine subject eligibility. To further characterise bronchodilator     responsiveness, post ipratropium testing will be conducted following completion of     post-albuterol/salbutamol spirometry.      Spirometry will be conducted at each post-randomisation clinic visit. Six hour post-dose     serial spirometry will be conducted at Visit 2. Trough spirometry will be obtained 23 and 24     hours after the previous day's dose of blinded study medication at Visits 3 to 9.      Assessments of dyspnea will be obtained using the Baseline and Transition Dyspnoea Index     (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnoea at     baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change     from baseline will be assessed using the TDI. Administration of the BDI and TDI should be     done prior to spirometry and any other study-related procedures Disease specific health     status will be evaluated using the St. George's Respiratory Questionnaire (SGRQ) and COPD     Assessment Test (CAT), at baseline (Visit 2) and Visits 4, 6 and 8.      The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2.     SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as     related to study participation (e.g., study treatment, protocol-mandated procedures, invasive     tests, or change in existing therapy) or related to a GSK concomitant medication, will be     recorded from the time a subject consents to participate in the study up to and including any     follow up contact.      Vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory     tests (hematology and blood biochemistry) will be obtained at selected clinic visits.      For determination of subject disposition, subjects will be considered to have completed the     study, upon completion of Visit 9. There is no plan to provide any of the active study     treatments for compassionate use following study completion.      The Intent-to-Treat (ITT) population will be the primary population of interest, and is     defined as all randomised subjects who have received at least one dose of the randomised     study medication during the Treatment Period.      Supplementary study conduct information not mandated to be present in this protocol is     provided in the accompanying Study Procedures Manual (SPM). The SPM will provide the site     personnel with administrative and detailed technical information that does not impact subject     safety.   "
104563|NCT01917500|"     The objectives of this clinical trial is to validate a S/W application to compare the     calculations of Hemodynamic parameters like Continuous blood pressure (BP) and Continuous     cardiac output (CO). This Hemodynamic parameters are computed from Pulse Oximeter     (PhotoPlethysmograph or PPG) signal with results obtained by NIBP intermittent measurements     and Echocardiography. The first phase of the study will be done on 10 patients of the     Cardiology dept.- Cardiac ICU, that have routine measurements of BP and CO using     Echocardiography.      The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the     data and a Smartphone S/W application that serves as the Hemodynamic calculator. The S/W     application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the     PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is     transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.      The Post-processing uses wavelet signal processing to estimate and display certain     Hemodynamic parameters like (Blood Pressure) BP and CO in a continuous and graphical way on a     standard Android Smartphone. In addition to the standard heart rate and SpO2, the application     displays the measured PPG signal and estimated continues BP and CO.      HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac     Output component and the resistance component in a mobile wearable device. Differentiating     between these 2 components can play a major role in helping the doctor to understand the     effect of cardiovascular medications and Lifestyle interventions.   "
104564|NCT01917487|"     The purpose of the study is to define the precision, accuracy and variability of the NBM-200     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.   "
104565|NCT01917474|"     Headache is a frequently disabling disorder, which occurs in about 30% of the adult     population, particularly in overweight/obese women. Aim of the study is to modify the     nutritional habits of the patients and to evaluate the effects of a low lipid intake vs. a     normal lipid diet on the incidence and severity of migraine crises. Moreover vascular     reactivity will be evaluated in a randomly selected subgroup of patients. This randomized,     cross-over intervention trial will be performed in about 150 patients, affected by migraine.     Adherence to the diet, particularly regarding energy intake, percent of energy from lipids,     carbohydrates and proteins will be carefully assessed at baseline and during the 2     intervention periods   "
104566|NCT01917461|"     This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to     enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at     identifying individual biomarkers and constructing a multi-parametric diagnostic model,     whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh     cohort of patients.      A collection of clinical, radiological and laboratory data will be gathered in order to     establish a final diagnosis. Blood samples will be analyzed and the levels of approximately     700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements     respectively.      A final diagnosis will be determined based on a majority decision of a panel of three or more     independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers     and combined sets of biomarkers for differentiating between distinct groups of patients will     be evaluated.   "
123443|NCT01670214|"     Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of     migraine or decrease them even in the patients with refractory migraine.   "
104572|NCT01917383|"     The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and     the safety and tolerability profile of trabodenoson ophthalmic formulation compared to     timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary     open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic     solution 0.005% once every evening (QPM).   "
104573|NCT01917370|"     The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism     in HCC growth, proliferation and apoptosis.   "
104574|NCT01917357|"     This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject     is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials,     with respect to protection against all antibodies (anti-hepatitis B surface antibodies,     anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella     pertussis) one (1) month after completion of the 6-10-14 week vaccination course.   "
104575|NCT01917344|"     Newborn screening and early treatment prevent the most severe manifestations of     phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder,     slow processing speed, and visual-motor problems commonly occur. Many adults with this     disorder also suffer depression and anxiety. Using advanced electroencephalogram (EEG) and     magnetic resonance imaging (MRI) techniques, including novel MR spectroscopy (MRS) we hope to     discover why this distinct constellation of deficits occurs in PKU. Adult subjects with PKU     will undergo EEG and comprehensive MRI evaluations, including a novel method of MR     spectroscopy to determine brain phenylalanine levels. In addition, they will receive     neurological and neuropsychological examinations and dietary evaluation.   "
104576|NCT01917331|"     Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to     demonstrate the superiority of the triple fixed combination of     Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent     dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of     treatment   "
104614|NCT01916837|"     In this prospective study the investigators sought to evaluate the feasibility of using the     genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact     on treatment recommendations.   "
104582|NCT01917253|"     The Long and Short is a prospective, randomized, controlled, open label trial to test the     complications of different device for peripheral vein cannulation, standard length (about 5     cm in length) and long catheter (about 12 cm in length), inserted with Seldinger technique.   "
104583|NCT01917240|"     To evaluate the impact of two FDA approved culture media on potential of human embryos     resulting from IVF (sequential & monophasic media). Half of each patient's embryos will be     randomly assigned to grow in monophasic media & the other half in sequential media. All     embryos will undergo Comprehensive Chromosome Screening (CCS) & the best euploid embryo from     each group will be transferred resulting in a double embryo transfer (DET). If there are only     euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or     frozen).   "
104584|NCT01917227|"     Objective:Health videos and group education to allow patients to a correct understanding of     diabetes and insulin treatment.      Method:      Standards and number of patients: The patients received subcutaneous insulin injection,     estimated 30 people enrolled.      Experimental Design and Methods:        1. Screening out-patient treatment with insulin use, HbA1c> 8% or poor postprandial glucose          (PPG)        2. At the time of the visits, invite the patient to participate in the Video group          education on insulin therapy By answering some questions about insulin injections, such          as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients          time to complete the questionnaire.   "
104585|NCT01917214|"     This is a retrospective, non-interventional study which looks at the cohort of Renal Cell     Carcinoma patients in a real life clinical setting and analyses into factors why these     patients have been surviving for as long as 3-5 years unlike Clinical study where the     survival is around 2 years.      The factors which will be analysed include patient characteristics, dosage and adverse event     management and tries to correlate these factors with survival.   "
104586|NCT01917201|"     The objective of this research is to assess the clinical results of implantation of different     drug eluting stents under aggressive intravascular ultrasound (IVUS) guided all the way up     to 24 months after operation and to establish the significance of the data of an optical     coherent tomography (OCT) for the assessment of direct results of stenting and the degrees of     endothelization of stent after 6 months.      The following hypothesis formed the base for this study:        -  IVUS guided intervention allows to improve the results and increase the safety of          implantation drug eluting stents.        -  Suboptimal results according to IVUS data can influence the follow up results of          treatment.        -  Suboptimal results according to OCT data, which are not revealed by IVUS, can influence          the follow up results of treatment.        -  The use of strategy of stenting with the achievement of optimal results under the          intravascular methods of visualization allows to reduce the time of application of          antiplatelet therapy.        -  The modern limus-eluting stents do not differ in the follow up results in investigated          criteria.   "
104587|NCT01917188|"     The initial aim of this study will be to assess current methods of heart failure (HF) patient     education in terms of patient satisfaction, level of preparedness for home, and care provider     satisfaction. The second aim will be to design and create a living with HF at home     simulation session. The third aim will test the hypothesis that hospitalized HF patients who     receive education in a simulation room in addition to usual HF education will have improved     qualitative and quantitative outcomes as compared to those who do not receive the additional     education support.   "
104588|NCT01917175|"     Set-up of a biobank for patients with an estimated date of infection seroconverters: store     plasma and cells samples at initial contact and during follow-up for future analysis and     analysis in international collaborative cohort seroconverters.   "
104589|NCT01917162|"     The purpose of this study is to compare the subjective performance of two daily disposable     contact lenses with respect to comfort and handling.   "
104723|NCT01915394|"     The principle purpose of this multicenter trial is to determine the definition, timing and     the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose     of the trial is to determine the prevention strategies of further spread of Respiratory     Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).   "
104590|NCT01917149|"     Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is     the most common indication for heart transplantation worldwide. Despite advances in medical     and device therapy, the 5-year mortality of patients with DCM remains high.      Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and     left ventricular ejection fraction(LVEF) <35% were selected for randomized controlled study     of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril     or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and     standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause     death or admission for heart failure. Additional prespecified outcomes included all-cause     death, cardiovascular death, all-cause admission, heart failure admission. Secondary     cardiovascular outcomes included the changes from baseline to the last available observation     after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral     regurgitation and wall-motion score index assessed by ECG. Adverse events were reported     during in-hospital observation and follow-ups.   "
104591|NCT01917136|"     This study is looking at differences in metabolism and functional imaging between pulmonary     hypertension subjects with normal right ventricular function and persistent right ventricular     dysfunction. We will also measure right ventricular metabolic and structural changes using     serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with     ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal     function patients). This is a companion imaging trial for patients who are eligible for the     treatment trial entitled A randomized, double-blind, placebo controlled, multi-center study     to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and     right ventricular dysfunction accompanied by a comparative study of cellular metabolism in     subjects with pulmonary hypertension with and without right ventricular dysfunction.     Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.   "
104633|NCT01916590|"     Both single shot femoral nerve block and continuous femoral nerve block with catheter have     been shown to be effective for pain control after anterior cruciate ligament reconstruction     (ACLR). Continuous femoral nerve block may be the more effective of the two in reducing pain     scores and opioid consumption for the first 48 hours postoperatively.   "
104705|NCT01915628|"     Prospective, multi-center registry to be conducted at 6 Canadian interventional cardiology     centers. The e-BioMatrix data will be compared with a historical control group, the Cypher     arm of the Biosensors Leaders study consisting of 313 patients. All patients will be followed     for up to 2 years.   "
104592|NCT01917123|"     In this randomized clinical trial before and after study we will assess the effect of     L-citrulline malate on brachial index in patients with coronary heart disease based on their     smoking history. Twenty patients with coronary heart disease with no history of diabetes or     other chronic diseases and with no history of myocardial infarction in the last 6 months will     participate in our trial.A written well-versed permission was attained from all patients. We     will measure the brachial index tow times once before giving L-Citrulline malate and the     other time after 2 weeks giving it.Patients receiving L-Citrulline malate as a 1 gram dry     powder agent twice a day, that should in use with 250 mg dilute water .The patients will     followed after 2 weeks by measuring brachial index which is our primary outcome measurement     in this trial.We assumed that the brachial index in both smoker and non-smoker group of     patients with coronary heart disease would change to normal or close to normal after giving 1     gram L-citrulline malate twice a day for 2 weeks.   "
104593|NCT01917110|"     The purpose of the study is to quantify the effectiveness of CooperVision MiSight® (omafilcon     A) soft (hydrophilic) contact lens in slowing the rate of progression of juvenile-onset     myopia.   "
104594|NCT01917097|"     This is a retrospective chart review to evaluate the postoperative course of all pediatric     patients admitted to the hospital following adenotonsillectomy over the past 24 months to     evaluate the incidence of bradycardia in children who received dexmedetomidine     intraoperatively and identify confounding factors which may be precipitating the bradycardia     or potentiating the negative chronotropic effects of dexmedetomidine.   "
104595|NCT01917084|"     To determine if an exercise program of passive range of motion (ROM) is safe and feasible in     infants with single ventricle (SV) physiology after their Norwood procedure.   "
104596|NCT01917071|"     Hypothesis: There is no difference in directional specific manipulation of the thoracic spine     for patients with neck pain.      Patients seeking physical therapy for neck pain routinely have their thoracic spine     manipulated. This study seeks to determine if directional limitations in the spine can be     specifically determined and treated to decrease neck pain.   "
104597|NCT01917058|"     The purpose of this study is to determine if receiving sub-cutaneous injections of a     medication called abatacept causes regrowth of hair in people with alopecia areata.      Among patients with alopecia areata, patients with worse disease are unlikely to have     satisfactory outcomes with current therapies. Our hypothesis is that Abatacept will be     effective therapy in moderate to severe alopecia areata by blocking re-activation of a     special type of immunecell call a memory T-Cell (CD8+NKG2D+)thereby blocking the inflammatory     response underlying alopecia areata.   "
104598|NCT01917045|"     The investigators noticed that Body Fat Ratio might have great influence on the efficacy of     different lipid soluble anesthetics. The objective of this clinical trial was to compare the     effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.   "
104609|NCT01916902|"     Subjects presenting with probable acute coronary syndromes scheduled for cardiac     catheterization will be enrolled in this study. Consented subjects will be randomized to     receive ticagrelor started with a loading dose immediately after enrollment versus receiving     a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but     prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and     the volume of thrombus within the new stent will be measured and compared between the groups.   "
104724|NCT01915381|"     AIM: Improve adherence to physical activity in people with Intellectual disabilities with a     Smartphone Application DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People with     intellectual disabilities in Occupational Center ( ASPROMANIS) INTERVENTION: DATA ANALYSIS:     descriptive statistics, measuring central tendency and dispersion of the variables study.     Inferential statistics will be made between intervention of key variables and outcome   "
104599|NCT01917032|"     Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient     Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable     preschool population, to corroborate the reported benefits of the experiences in other     countries.      Question: Will it improve the nutritional status and hematological levels after the home     fortification with Sprinkles in children of two child care centres in the city of Medellin,     in 2013?      Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will     be better in the intervention group with Sprinkles, compared with the placebo group.      Design: Randomized clinical trial, triple-blind and placebo-controlled.      Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or     with severe malnourished, full-time assistants to two children's centres that have the same     alimentation menu.      Intervention: The daily diet will be supplemented with sprinkles in one of the children's     centres and will be compared anthropometric and hematological values before and after with a     group receiving the same diet with placebo.      Outcome measures: Nutritional status (anthropometric measures) and haematological values     (hemoglobin, ferritin, transferrin and folate).   "
104600|NCT01917019|"     This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled     parallel-group period, and Part B and C are open-label extension periods. The primary     objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release     Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in     Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind     portion of the study is to evaluate the safety and tolerability of prolonged-release     Fampridine in this study population. The primary objective of the open-label extension study     (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The     primary objective of the additional open-label extension (Part C) is to provide participants     who complete the study with continued access to prolonged-release fampridine until marketed     drug can be used at the applicable site or until sponsor decision to discontinue the study.   "
104601|NCT01917006|"     This is a safety and efficacy study of BOTOX® (onabotulinumtoxinA) for the treatment of     premature ejaculation in male patients.   "
104602|NCT01916993|"     The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics     (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a     drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal     hepatic function or mild, moderate, or severe hepatic impairment.   "
104603|NCT01916980|"     This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese     participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study     is that the sum of the daytime and nighttime pruritus/itch scores for both the     eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week     2 compared to Baseline.   "
104604|NCT01916967|"     This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese     participants with chronic urticaria. The primary hypothesis is that the efficacy of     desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in     the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.   "
104716|NCT01915485|"     Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in     its membrane. Furthermore, very little is available to treat patients who have disease     progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA     Tyr3-octreotate which is a ligand to somatostatin receptors.   "
104605|NCT01916954|"     Malaria in pregnancy is a major cause of maternal and newborn morbidity and mortality in     sub-Saharan Africa]. Effective antimalarial preventive and treatment regimens can     significantly reduce malaria-related morbidity and mortality in the mother and baby. However,     therapeutic choices are limited by concerns about possible toxicity to the fetus and because     of these concerns pregnant women are normally excluded from clinical trials. This, combined     with the lack of adverse events reporting system, results in a scarcity of data on drug     safety and efficacy in pregnancy. Moreover, changes in the maternal physiology in pregnancy     often alter the pharmacokinetic of drugs. Artemether-lumefantrine (ALN) is a highly     efficacious artemisinin-based combination therapy approved by the World Health Organisation     for use in the 2nd and 3rd trimesters, although it is still infrequently used in pregnancy     and there is uncertainty as to the optimum dose. The pharmacokinetics of ALN are altered in     pregnancy, resulting in reduced plasma concentrations and while the standard adult dose is     still effective in high transmission settings, where pregnant women have higher levels of     immunity, efficacy is reduced significantly in low transmission settings where women have     lower levels of immunity. Inadequate antimalarial treatment dosing in pregnancy risks     treatment failure or breakthrough infection and exposure of malaria parasites to     sub-therapeutic drug concentrations thus selecting for drug resistance.   "
104606|NCT01916941|"     The study uses neurobiological measures through brain imaging, neuropsychological measures,     and selfreport measures to try to understand how an effective treatment for alcoholism works.     On the whole, less than 50% of people with alcoholism get better with treatment. This study     will help researchers develop better treatments for alcoholism because if the investigators     know why the treatments the investigators use are working, and in whom the treatments work     best, then the investigators may be able to make treatment more effective by targeting     treatments to individuals who would be most likely to benefit and by guiding development of     more effective treatments in the future.   "
104607|NCT01916928|"     Women presenting to Washington Hospital Center with fetal loss would be offered participation     in the study. The objective is to determine if ccffDNA obtained from maternal blood is     present in the setting of missed abortion or fetal demise.      The investigators primary hypothesis is that cell free fetal DNA will be present in maternal     blood in the presence of a failed pregnancy.   "
104608|NCT01916915|"     Patients experience considerable amount of pain after cesarean section. The aim of this study     is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a     local anesthetic) in continuous wound infusion (which is done by placing a catheter in the     incision) after cesarean sections.   "
104621|NCT01916746|"     The aim of this study is to further demonstrate the safety and effectiveness of transvaginal     resection of pregnancy tissue in the treatment of Caesarean Scar Pregnancy (CSP).   "
104610|NCT01916889|"     Delirium is a serious medical condition associated with increased mortality, longer hospital     stay, increased rates of institutionalisation, and declines in post-admission functionality.     Despite the prognostic utility of diagnosing delirium and its utility as an important     indicator of health quality in elderly patients in developed countries, it is not routinely     screened for in many busy general medical in-patient settings, especially in developing     countries. Unpublished data from a recent study of general medical in-patients in Groote     Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week     period received any formal cognitive testing or had documentation of the presence/absence of     delirium in routine clinical notes. This under-recognition is largely the result of the     length and complexity of available delirium diagnostic tools e.g. Mini-mental state exam     (MMSE), although the perceived lack of clinical importance and conflicting results about     specific treatment modalities also contribute.      The investigators recently developed the simple 4-question RACY delirium screening tool for     use in general medical in-patients. Preliminary data show the test to be simple and effective     with a sensitivity and specificity of 78% and 85% respectively using a ROC-selected cut-point     of RACY≤2. The investigators hypothesis that the RACY screening tool has the potential to be     a simple and effective bedside delirium diagnostic instrument for use in non-geriatric, busy     general medical in-patient settings. This study is a two-centre validation study to evaluate     the diagnostic accuracy of this tool.   "
104611|NCT01916876|"     The post discharge time is a vulnerable time for general medical in-patients, with high rates     of adverse events that may cause unnecessary readmissions and even death. A recent study of     415 patients discharged from the general medical wards at Groote Schuur Hospital,     demonstrated a very high 12 month mortality of 35%. The majority of these deaths were     classified as unexpected. The reasons for this were not further examined, but it was     speculated, given the authors' knowledge of the public sector in Cape Town, that three     related factors contribute significantly to this early mortality: i) a lack of continuity of     care, with patients not necessarily accessing the primary care support treatment that they     need or being able to access early post discharge follow-up (for example for anti-retroviral     or anti-tuberculous care); ii) the inability of primary care to deal with the complex nature     of the discharged patients, most whom have significant co-morbid disease; iii) A lack of     optimisation of therapy for chronic disease after acute discharge.      The investigators hypothesise that an integrated post-discharge transitional care package,     which includes an early medical specialist follow-up in the first 3 months after hospital     discharge will decrease the 6- and 12-month mortality and re-admission rate amongst general     medical hospital admissions in Cape Town, South Africa. Our study will compare an integrated     package, suitable to implementation if effective, with current standard discharge packages.   "
104612|NCT01916863|"     The purpose of this study is to assess the effect of LX4211 and the comparator drug     canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy     subjects in comparison to placebo.   "
104613|NCT01916850|"     The primary objective of this study is to evaluate the safety and tolerability of multiple     oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive     days) in healthy subjects.   "
104615|NCT01916824|"     During episodes of depression patients with MDD may make sub-optimal decisions based on     exaggerated negative beliefs about themselves, the future, or the world around them. These     disruptions in decision-making contribute adversely to quality of life, in both work and     personal realms. Although effective treatments for depression are available, very little work     has explored the effects of treatment on how people make decisions. The specific aspects of     decision-making that differ between depressed and health control individuals are unknown, and     whether any changes in these decision-making features occur as a result of improvement from     depression, or whether medication treatment itself can lead to changes in decision-making,     even in the absence of clinical improvement.      In this trial, fifty participants with current major depressive disorder who are not     receiving an antidepressant medication and fifty healthy controls will complete     questionnaires and computerized tasks to assess their decision-making styles. There will be     three visits for depressed patients and two for healthy controls (the first and third     visits). The first visit will involve interviews and questionnaires to assess the     participant's level of depression, medical history and quality of life. Participants will     then complete the decision-making tasks, and will earn between $5-40 based on their choices,     in order to make the decisions on the computer tasks financially meaningful. At the     completion of this visit, depressed patients will be prescribed an FDA-approved     antidepressant, chosen in consultation with the treating psychiatrist. Patients will be     responsible for paying for the prescription themselves. After two weeks on the medication,     the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After     six weeks on the medicine, patients and healthy controls will return to repeat the     questionnaires and the computer based decision-making tasks, and will again earn between     $5-40 based on their performance.      The overall goal of this study will be to identify whether decision-making characteristics in     people with major depression is affected by treatment, and whether depressed patients make     decisions differently from healthy controls. A total of 4 decision-making tasks and one     control task will be administered via computer to eligible subjects.   "
104616|NCT01916811|"     The mian purpose of this study is to analysis the imaging changes in 3.0T MRI of lumbar small     joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered with low     back pain.   "
104617|NCT01916798|"     Intralipid can suppress natural killer cells that are known to be involve in repeated     implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil,     egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid,     omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing     natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin     (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the     pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of     miscarriage and who have positive peripheral blood natural killer cells   "
104618|NCT01916785|"     This protocol is a multicentric interventional phase II study from the French CML Intergroup     (FILMC).      The core of the protocol is to explore the efficacy and safety of an optimization strategy     consisting in the modulation of the dasatinib daily dose according to the results of repeated     plasmatic levels of dasatinib.      The objective of this strategy is to improve the overall results of the treatment of early     CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.      The study will be conducted in selected FILMC and Canadian centers.      The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb.     The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing     authorization is granted in that indication.   "
104619|NCT01916772|"     To observe the natural history of cherubism.   "
104620|NCT01916759|"     To use a systems biological approach to study the molecular signatures of innate and adaptive     responses to vaccination in a HIV infected versus uninfected adult population in Kampala,     Uganda.   "
104654|NCT01916304|"     The purpose of this study is to investigate the effect of switching participants taking     levothyroxine to a new sodium formulation.   "
104622|NCT01916733|"     The aim of this study is to examine the effect of moderate glucose (blood sugar) control in     diabetic and non-diabetic patients undergoing leg bypass surgery (LEB) or open abdominal     aortic aneurysm (AAA) repair. We hypothesize that use of Fletcher Allen Health Care's current     insulin infusion strategy will result in improved blood sugar control which will translate     into decreased postoperative morbidity (fewer complications) and better long term outcomes     when compared to patient outcomes at other institutions which utilize other blood sugar     management strategies.   "
104623|NCT01916720|"     The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques     after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives     include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and     plaque, specified biomarkers in blood and plaque and their respective correlation's with     Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of     SB-480848, and safety and tolerability in this population.   "
104624|NCT01916707|"     Hospitalized trauma patients frequently suffer from blood clots in the legs or lungs. To     minimize the risk of these blood clots developing, patients may be given a blood-thinner drug     such as enoxaparin.      Until now, a set dose of enoxaparin has been given to a patient, regardless of his or her     weight. However, a recent study suggests that for obese patients, the set dose may be     inadequate. The purpose of this study is to evaluate whether or not a dose of enoxaparin that     is based on the patient's weight will help to prevent the formation of blood clots.      The information gathered through this study will help doctors to understand the best way to     prevent blood clots in future trauma patients. The potential risks of participating in this     study include the minor risks of blood draws and ultrasounds, as well as the more significant     risks of bleeding as a side effect of the enoxaparin.   "
104634|NCT01916577|"     The purpose of this study is to determine if the drug Plerixafor (Mozobil) can lead to     clinically relevant efflux of CD117+ stem cells from the bone marrow to the peripheral blood     of normal controls and patients awaiting lung transplantation. The investigator's hypothesis     is that Plerixafor (Mozobil) will lead to significant mobilization of CD117+ stem cells to     the peripheral blood.   "
104635|NCT01916564|"     This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus     bisacodyl for bowel preparation for morning outpatient colonoscopy.   "
104647|NCT01916395|"     The primary objective is to determine whether inflammatory markers, such as C-Reactive     Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide     (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated     with Imitrex or Treximet.      The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive     Protein (CRP) in patients with active migraine headaches.   "
104731|NCT01915290|"     This is a substudy of the Generation-100 study (NCT01666340). Self reported physical activity     versus objectively measured physical activity and its correlation to maximal oxygen uptake in     an elderly Norwegian population (observational study).   "
104625|NCT01916694|"     Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems     for both mothers-to-be and their babies such as causing a large baby and difficult birth.     Gestational diabetes in the mother may also lead to effects on the long term health of the     baby.      Most people today use mobile phones. Our research is looking at using a mobile phone app to     help with diabetes care in pregnancy. In particular, the investigators are using phones which     connect to the standard blood glucose monitoring machines given to all women with gestational     diabetes to see if sending the hospital team blood test results between clinic appointments     can result in the need for fewer clinic visits. The investigators are also testing to see how     acceptable using mobile phones in this way, is to our patients and that the control of the     blood glucose and outcomes for the mother and baby are at least as good as standard care.      The investigators are planning to recruit 200 women who receive care for their gestational     diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be     randomised so that 100 will receive standard care, and 100 will have a mobile phone app     linked to the blood glucose machines to send blood glucose readings directly to the diabetes     care team to review.      Both groups will be asked to test their blood glucose levels at home regularly with a     glucometer. All participants will also be given lifestyle advice to reduce the chance they     will need medication. Blood glucose control will be measured also by the percentage of     glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before     delivery.   "
104626|NCT01916681|"     The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and     continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase     (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time     periods to define a failed IOL, there are no guidelines or accepted definitions of when to     call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged.     While decreasing the CD rate is an important primary focus in obstetrics, attention must also     be paid to the overall length of labor given that prolonged labor is associated with adverse     maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase     in direct hospital costs and healthcare utilization. The use of cervical ripening agents,     such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor     time and CD rate. In addition to specific individual agents, certain dosing and regimens for     IOL and active labor have been compared to evaluate whether a particular dose or regimen can     decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus     on individual induction agents and few have compared the efficacy of using more than one     agent simultaneously. Given the associated risks of prolonged labor and limited data     evaluating the use of combined cervical ripening agents, our objective is to evaluate the     difference in time to delivery among women who undergo an IOL with four different methods.   "
104627|NCT01916668|"     Observational evidence indicates that intradialytic hypertension is associated with high     morbidity & mortality. The investigators impression is that this problem may be more     prevalent than initially suspected. To the investigators knowledge, there are no studies on     intradialytic hypertension in the South African haemodialysis population.   "
104725|NCT01915368|"     The investigators will conduct a proof-of-concept study to provide preliminary evidence of     efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute     stroke rehabilitation.   "
104628|NCT01916655|"     OSA is a major chronic condition affecting the quality of life of millions of Americans. Per     the Institute of Medicine new treatment adherence strategies are needed to help improve the     quality of care, reduce social and economic costs, and help those with chronic conditions     (such as OSA) live healthier and more productive lives through better management of their     conditions. Using an mHealth tool to help deliver the investigators' Self-Management     intervention and improve the frequency and quality of patient-provider communications is a     central component of that discovery process.   "
104629|NCT01916642|"     IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction     of anesthesia.   "
104630|NCT01916629|"     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the     safety and efficacy of Photocil in the treatment of psoriasis   "
104631|NCT01916616|"     Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords while     inhaling. Children and adolescents with VCD may experience multiple symptoms, including     difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There is limited     information on optimal management of VCD. In our proposed study, we will use     cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD     symptoms. Measurements of airflow during breathing as well as symptom frequency and intensity     will be examined prior to and following a series of four therapy sessions with a clinical     psychologist that are focused on teaching patients strategies to decrease symptom reactivity.   "
104632|NCT01916603|"     NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs     origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies show     that maternal BMI before conception and during pregnancy predict future risk of obesity and     associated metabolic conditions in both mother and offspring. Weight gain during the first     two years of life is also critical in defining the infant's predisposition to obesity during     adulthood. Objective: to assess the effectiveness of delivering a primary health care     intervention to enhance compliance with updated nutrition and health care (diet, physical     activity and breastfeeding) standards from early pregnancy through the first year of life.     Methods: cluster randomized controlled trial (CRCT), designed as a public health intervention     program effectiveness study (i.e. intervention will be available through the established     national health system under standard operating conditions). A cluster unit will be a primary     health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly allocated to:     enhanced nutrition and health care (intervention group) or routine nutrition and health care     (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20% loss to f-up we     will complete 960 women per arm. After randomization, pregnant women in the intervention     PHCCs starting at their first pre-natal visit (< 15 wks.) will receive, diet and physical     activity (PA) counseling-support based on updated recommendations and monitoring goals for     weight gain & glycemic control and breastfeeding (BF) promotion till 12 m postpartum.     Pregnant women who attend control PHCCs will receive routine antenatal care according to     national guidelines. Expected results: participants in the intervention PHCCs will benefit by     achieving adequate nutritional status & metabolic control, during and early after, pregnancy     as well as adequate infant growth & development as a result of improved nutrition and health     care practices. The results will likely be generalizable through the primary health care     system; considering this is a program effectiveness trial conducted under real life     conditions . Additionally, we will include specific ancillary mechanistic projects to better     characterize the intervention and its impact.   "
106163|NCT01896440|"     We will study the effects of ondansetron on measurements of electrical activity in the heart     to make sure doses we are using to prevent nausea and vomiting in children receiving     chemotherapy are safe.   "
104636|NCT01916538|"     The Anorexia Nervosa Genetics Initiative (ANGI) is the largest and most rigorous genetic     investigation of eating disorders ever conducted. Researchers in the United States, Sweden,     Australia, and Denmark will collect clinical information and blood samples from over 13,000     individuals with anorexia nervosa and individuals without an eating disorder.      ANGI represents a global effort to detect genetic variation that contributes to this     potentially life-threatening illness. The goal of the research study is to transform     knowledge about the causes of eating disorders to work toward greater understanding and     ultimately a cure.      If you have suffered from anorexia nervosa at any point in your life, you can help us achieve     this goal. Your contribution would include a brief questionnaire and a blood sample. If you     have never had anorexia nervosa, but still want to contribute, we invite your participation     as well.   "
104637|NCT01916525|"     The objective of this multidisciplinary study is to employ health-economic evaluation in     determining the health benefits achieved with exercise-based cardiac rehabilitation and the     costs derived from it compared with conventional post-acute care of cardiac patients in the     Finnish health care system.   "
104638|NCT01916512|"     The aim of this study is to determine whether high high density     lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP)     activity is atherogenic or not in subjects who received health checkups. We investigate the     association between CETP activities and the severity of atherosclerosis assessed by     intima-media thickness (IMT) and compare the atherogenic change between in subjects with high     HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining the     morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG) change,     Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and various     serum atherogenic markers. And we also examine the correlation between normal lipid profile     and concentration, activity and function of surface lipoprotein in subjects with variety of     lipoprotein levels, including patients with hyper-LDL-cholesterolemia,     hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant     cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.   "
104639|NCT01916499|"     This study involves adolescents operated with arterial switch procedure for transposition of     the great arteries during the neonatal period. The purpose is to evaluate the coronary     arteries and direct and indirect findings of coronary artery disease/complications with 3     tesla magnetic resonance imaging.   "
104640|NCT01916486|"     The investigators will conduct a proof-of-concept randomized controlled trial study to     provide preliminary evidence of efficacy of exercise training or a complex mental and social     activities program for improving cognitive function in older adults with chronic stroke,     compared with a stretch and relaxation program.   "
104641|NCT01916473|"     Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between     the epidural and continuous wound infusion techniques.   "
104655|NCT01916291|"     Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has     intact membrane after 38weeks of gestational age. The investigators study safety and efficacy     of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks   "
104642|NCT01916460|"     Patients who empty their stomach slowly may have what we call Slow gastric emptying or     gastroparesis. These patients can have some changes in the thickness of their stomach wall.     In addition, they may have loss of some important nerve cells in their stomach muscles. The     loss of these cells can cause slow emptying of the stomach. Obtaining a sample from the     stomach wall to examine the loss of these cells can help in diagnosing gastroparesis. Up to     now, the only way to obtain a tissue sample from the stomach muscle was to undergo an     operation in the surgery suite and be hospitalized for several days after the procedure.     Usually, we obtain this sample while these patients are having a surgery for another purpose     such as placement of a gastric stimulator (a machine which is inserted in the stomach wall to     control the stomach rhythm and thus help the stomach to empty faster). Endoscopic ultrasound     is an endoscope (a tube with a source of light and ultrasound installed in the tip of the     tube) that can measure how thick the stomach wall is and can provide sample biopsies of the     stomach wall which can be studied for the loss of these specialized muscles and cells.      We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to     diagnose gastroparesis and can replace the need for obtaining samples by surgery.     Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.   "
104643|NCT01916447|"     The purpose of this study is to investigate the safety and determine the maximum tolerated     dose of TAS-102 administered in combination with CPT-11 in patients with advanced     gastrointestinal tumors.   "
104644|NCT01916434|"     Consumption of fish can help to prevent cardiovascular disease. The precise way in which fish     is beneficial is not fully understood. This is important to find out as fish consists of a     complex mixture of fatty acids and micronutrients such as vitamin D and selenium that could     individually, or collectively, be responsible for the beneficial effects.      Fish farming in Scotland is playing an increasingly important role in the provision of fish     for human consumption. But issues with sustainability of raw materials are requiring fish     farming to reformulate fish diets, which may affect the levels of beneficial omega-3 fatty     acids and other components in fish.      In this study we will be comparing the long-term health effects of eating two portions a week     of Scottish salmon raised on a traditional fish diet versus eating two portions a week of     Scottish salmon raised on a more sustainable fish diet. In addition, we will be looking at     differences in health outcomes when eating two portions a week of either Scottish salmon,     compared with eating no fish at all.   "
104645|NCT01916421|"     Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a     flexible tube with a camera and small ultrasound machine at its end )requires the use of a     needle for taking the sample from the lesion or what we call Fine needle aspiration (FNA).     Currently, FNA is done by three commercially available needles. These needles are used     routinely in our institution for FNA. The data regarding the safety and the successfulness of     any of these needles are lacking. We sought to compare all three commercially available     needles in a prospective manner.   "
104646|NCT01916408|"     The aim of the present study is to investigate changes in inflammatory status and incidence     of infection after extreme aerobic physical stress (participation in a marathon). In     addition, the impact of marathon running on the hemostasis and muscular state will be     evaluated. Changes at the inflammatory, muscular, and rheological level will be related to     ingestion of oral hydrolytic enzymes and bioflavonoids.   "
125933|NCT01636700|"     The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol     infiltration or intravenous for tonsillectomy.   "
104648|NCT01916382|"     This is a proposal to develop the orphan designated drug, nitisinone, for the treatment of a     rare Mendelian disease, Alkaptonuria (AKU). Thanks to our existing successful fundamental and     clinical research (cell models, animal models, natural history studies), we are now ready for     this final stage of clinical development of nitisinone for AKU: a phase 3 clinical trial to     prove efficacy. The results of DevelopAKUre will allow us to make the case to the European     Medicines Agency for marketing authorisation of nitisinone for AKU, thereby contributing to     the goal of the International Rare Diseases Research Consortium of developing 200 new     therapies by 2020.   "
104649|NCT01916369|"     The primary objective of the Phase I ascending dose trial is to investigate the safety and     tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product,     CTX, in patients with peripheral arterial disease (Fontaine Stage II through IV). This trial     is based on independent preclinical data from a leading academic research institution that     has been submitted for publication. Inclusion of patients with Fontaine Stage II is justified     as these patients have a lower incidence of background events and will facilitate distinction     between events which are possibly intervention-related versus spontaneous events associated     with underlying advanced atherosclerosis. The trial is designed to treat 9-18 patients and     evaluate safety measures over a 12 month follow-up period.   "
104650|NCT01916356|"     The purpose of this study is to determine the effectiveness of an online informational video     in improving knowledge about infertility in couples experiencing problems conceiving. A pilot     study will be conducted with first and second year medical students.   "
104651|NCT01916343|"     Gynecologists are currently using laparoscopy to perform many surgeries traditionally     approached by laparotomy. The technical skills required for laparoscopic surgery are     different than the skills required for laparotomy, causing a prolonged learning curve.     Currently there is no standardized laparoscopy curriculum for gynecology residents. This     study aims to develop a specific evidence-based surgical skills gynecologic curriculum that     could be instituted in residency programs at a national and international level. The     investigators will then validate the curriculum using Obstetrics and Gynecology residents     through a cognitive examination, a technical skills examination, and a video recording of     performance in the operating room.      HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive     laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team     training exercises. The investigators hypothesize that residents in the experimental     curriculum-trained group will perform better than the residents in the traditional residency     curriculum-trained group on a cognitive examination, a technical skills examination, and in     the operating room. The operating room performance will be judged by blinded experts on a     previously validated evaluation tool.   "
104652|NCT01916330|"     Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and     fetus   "
104653|NCT01916317|"     Voltage Gated Sodium Channels Over the years, there is more evidence that ionic channels are     involved in the oncogenic process. Among these, voltage gated sodium channels (VGSC)     expressed in non-nervous or non-muscular organs are often associated with the metastatic     behavior of different cancers.      Expression of VGSCs has been reported both in vitro and/or in vivo in a range of human     carcinomas, including breast cancer Ion channels are major signaling molecules expressed in a     wide variety of tissues. They are involved in determining a variety of cellular functions     like proliferation, solute transport, volume control, enzyme activity, secretion, invasion,     gene-expression, excitation-contraction coupling, and intercellular communication.4 VGSC     activity contributes to much cellular behavior integral to metastasis, including cellular     process extension, lateral motility and galvanotaxis, transverse invasion, and secretory     membrane activity.      A correlation between Na transport and oncogenesis has been widely reported in literature. In     1980, transformed mouse mammary cells were shown to have 3-fold higher intra-cellular sodium     content than untransformed cells.5 Additionally evidence suggest that increasing the inward     sodium current through voltage gated sodium channels increased the invasive capacity of     breast cancer.6 Also, growth and proliferation of mammary adenocarcinoma cells can be     inhibited by Amiloride suggesting that epithelial Na channels (ENaC) activity is correlated     with proliferation of breast cancer cells      Current evidence suggests that VGSC activity is necessary and sufficient for cancer cell     invasiveness8. A recent in vitro study has shown that the human MDA MB 231 breast cancer cell     line expressed functional VGSCs9. However, the molecular nature of the VGSC and its     functional relevance to breast cancer in vivo are currently under study.      Surgical operations for cancer have been reported to induce dissemination of cancer cells     into surrounding tissues or into the circulation10,11and infiltration anesthetics can inhibit     immune response12-14. Although the mechanism remains to be elucidated, infiltration     anesthetics such as lidocaine have membrane- stabilizing action (Seeman, 1972) and these     agents could have direct effects on cancer cells. Therefore, it is important to clarify the     effects of infiltration anesthetics on behavior of the tumor cells.      Commonly used local anesthetic agents inhibit the VGSCs and also possess a unique membrane     stabilizing action through other unknown mechanisms. A study by Mammota et al 15 reported     that lignocaine, effectively inhibited the invasive ability of human cancer (HT1080, HOS, and     RPMI-7951) cells at concentrations used in surgical operations (5-20 mM). Lidocaine reduced     the invasion ability of these cells by partly inhibiting the shedding of HB-EGF from the cell     surface and modulation of intracellular Ca2+ concentration contributed to this action. In     addition, lidocaine (5-30 mM) infiltrated around the inoculation site, inhibited pulmonary     metastases of murine osteosarcoma (LM 8) cells in vivo.      Dose of lidocaine15:      40 mM (1%) lidocaine is usually used for infiltration anesthesia for surgical operations.     Lower concentrations (1-20mM) of lidocaine were sufficient to suppress the invasive ability     of cancer cells14. One mM lidocaine inhibited the invasive ability of HT1080 cells by about     50%, and 20 mM lidocaine inhibited the invasion ability completely. Lidocaine also inhibited     dose-dependently the invasive ability of HOS and RPMI-7951 cells, although it was less     effective on HOS cells. Lignocaine exerts its anesthetic action by obstructing the sodium     channel 16 however, 10 mMof tetrodotoxin (TTX), a specific sodium channel inhibitor, had     little effect on the invasive ability of HT1080 cells. Ten mM lidocaine-N-ethylbromide (NEB),     which does not cross the cell membrane, also had little effect on the invasive ability of the     cells.      Objectives      Primary Objective:      • To assess the in-vivo ability of local anesthetics agents like lignocaine to decrease the     dissemination of cancer cells during surgery and improve the disease free interval      Secondary Objective      • To assess the in-vivo ability of local anesthetics agents like lignocaine on impacting long     term survival.      Methodology / Treatment plan      The study drug (0.5% lidocaine 60mM) will be tested in the intraoperative setting prior to     surgery will be tested in a randomized setting.:      Arm A: 60mM of 0.5% lignocaine will be injected peritumoral prior to excision. The local     anesthetic should be injected on all 6 surfaces of the tumor and also within the tumor. Wait     for 7 minutes for its action followed by surgery. (Intervention arm) Arm B: No injection of     lignocaine prior to excision (Control arm)   "
104658|NCT01916252|"     This protocol is a national, multicenter, comparative, open-label, randomized trial comparing     the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL     versus. MEL-200).      A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits     will take place during the pre-treatment, treatment and follow-up periods.      The pre-treatment period includes the screening visit in which participants provide informed     consent in writing in order to take part in the study. The patient is then assessed to     determine his/her eligibility. The selection process will begin 21 days before the first dose     of medication is administered (days -21 to 0). During the treatment period, eligible patients     will be included in the study and given six cycles of induction treatment with bortezomib/     lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC     bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of     each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.      After the first three induction cycles, and in the absence of progression or unacceptable     toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using     G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation     ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take     place at the beginning of the study, once the screening is complete and the patient's     eligibility verified. Three months after transplantation, patients will receive two cycles of     consolidation treatment with VRD-GEM at the same doses administered during induction     treatment.      Once the treatment phase is complete, patients will begin the follow-up phase in which they     will be visited every three months to evaluate disease progression and survival   "
104659|NCT01916239|"     The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively     metabolized by the human gut microbiota to yield a number of metabolites called urolithins     (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes     involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the     human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer     activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules     containing three different pomegranate extract formulations until surgery. The aims of this     trial are:        -  To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and          normal colon tissues.        -  To evaluate gene expression profiling and protein markers in tumoral and normal colon          tissues from these patients.        -  To compare different pomegranate extract formulations on the above.   "
104660|NCT01916226|"     This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week     treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and     ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS     provides greater nasal symptom relief than cetirizine. The primary measure used to test this     hypothesis is the change from baseline over two weeks in reflective total nasal symptom score     (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized     into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five     sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The     total duration of study will be approximately 21 days including 7 days of screening period,     and 14 days of treatment period.   "
104661|NCT01916213|"     The investigators would like to assess whether selecting mature sperm using PICSI (selecting     for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .      Aim        1. Primary outcome: To compare routine sperm selection using ICSI with sperm selection          using PICSI plates in terms of implantation and fertilization rates for couples with          male factor fertility        2. Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage          rates for couples with male factor infertility using routine sperm selection with ICSI          compared to using PICSI plates for sperm selection      Hypothesis:      Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison     to sperm selected for conventional ICSI   "
104662|NCT01916200|"     This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy     and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder     (MDD) comorbid Irritable Bowel Syndrome (IBS).      Subjects will be patients who are referred to the outpatient or inpatient clinic of     gastroenterology departments of province level general hospitals in China. All subjects     present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD     by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written     informed consent prior to participating in the study. Subjects will be assessed for     eligibility at a screening visit, with eligible patients returning for a assessment within 1     week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose:     12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be     evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study     treatment visits.   "
104663|NCT01916187|"     The purpose of this study is to determine the best dose of imetelstat when given alone for     patients with neuroblastoma and also when given in combination with 13-cis-retinoic acid.   "
104664|NCT01916174|"     This trial is conducted in Europe. The aim of this trial is to assess the expected biological     equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with     identical active ingredient in healthy volunteers.   "
104665|NCT01916161|"     Inflammatory Bowel Diseases (IBD) are life-long, incurable illnesses that can have a profound     effect on the patients quality of life. Disease education is a corner stone of IBD care to     enable patients to take up an active role in their disease management. While patient     education is enshrined in the IBD standards, actual patient knowledge is often poor.3     Knowledge is not associated with the level of the patient's educational achievement, but     member of patient organisations such as Crohn's and Colitis UK (CCUK) have significantly     better knowledge than non-members. This may highlight the positive effects of education     offered by CCUK, but it is also conceivable that patients with a greater interest in their     disease are more like to join organisations like CCUK. Different sources of patient     information may therefore influence what level of disease related knowledge a patient     achieves.      Apart from high quality clinical information provided by professional organisation (British     Society of Gastroenterology, European Crohn's and Colitis Organisation), the National Health     Service and charities (CORE, CCUK), there is also a host of unregulated information     available. The emerging dominance of the internet for information gathering has provided easy     access for patients to a host of websites providing information on IBD. A number of these     provide alternative (not evidence based) views, which could have a potentially negative     impact on patient's knowledge. Furthermore patients often share their stories on internet     forums and it is likely that those stories share are more likely to represent the extreme     ends of disease rather than those experienced by the majority. This could potentially cause     anxiety in patients with IBD. The quality of information found on the internet varies widely     and up to 50% of websites have been judged as poor. The vast majority of patients with IBD     have access to the internet and more than half use to search for health related information.7     We have previously also demonstrated that patients with anxiety have better disease related     knowledge of IBD.   "
104666|NCT01916148|"     This purpose of this study is to determine the ability of an     18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET scan to detect a focal lesion of     hyperinsulinism and determine the location in patients with congenital hyperinsulinism,     Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.   "
104857|NCT01913626|"     assessing the Efficiency of cognitive group therapy for patients with subjective memory     complains, using the neuropsychological computerized assessment of WebNeuro by Brain resource     (BRC).   "
104667|NCT01916135|"     This study is the first time that a new experimental drug called [18F]-SKI-249380 is being     used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that     will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its     injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find     tumors in patients.      This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is     given to people in tiny amounts by an injection into a vein in their arm, and to see where     [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study     doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380     are better for finding tumors compared to the standard types of scans that doctors use.   "
104668|NCT01916122|"     These are tumors which expresses estrogen receptors. Estrogen receptors are found within     breast cancer cells and are an important marker of which medicines may best treat a breast     cancer. This study is being performed to imaging the amount of estrogen receptors expressed     in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors     and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a     machine that can take pictures of where the FES is and how much FES is present. The results     of this study may help researchers know whether FES can be used to monitor changes in     estrogen receptors in tumors during treatment.   "
104669|NCT01916109|"     The purpose of this study is to find out if using the combination of standard chemotherapy     (gemcitabine and carboplatin) plus this new drug (panitumumab) can help to shrink the tumor     before the patient undergoes surgery for bladder cancer.   "
104670|NCT01916096|"     The primary objective of the study examines the success rate of various OneTouch Delica     lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is     based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4     times with two lancet sizes at a single depth setting. There will be 120 paired lancing     events for each lancet size within the group.      Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of     1.0μL for the 28g lancet across all depth settings.      Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for     the 28g lancet across all depth settings is less than 90%.   "
104686|NCT01915875|"     The purpose of this study is to evaluate the impact of the global approach to the pain in     cystic fibrosis patients with chronic or intermittent pain. The patients will receive in     addition to an usual pharmacological and psychological management, sophrology sessions at     home. The results of this study will provide a new strategy of management of the patient's     pain.   "
104687|NCT01915862|"     The purpose of this study is the evaluation and comparison of blood pressure variability     indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure     monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.   "
104671|NCT01916070|"     Patients with the symptom complex syncope or near-syncope are quite often in the emergency     department. Most patients with syncope have a positive prognosis. However some types of     syncope are associated with an increased morbidity and mortality. It is a challenge to detect     these patients reliably at an early stage. The current guidelines contain exact definitions     concerning the characteristics of patients with syncope and recommendations on how to     diagnose and treat these patients following standardized pathways. Due to the fact that     near-syncope is poorly defined and therefore seldom evaluated in clinical trials, data     concerning near-syncope are rare.      Our aim was to characterize patients presenting with syncope or near-syncope to the emergency     department regarding their risk profile, comorbidities and prognosis. First we evaluated if     there is a difference between the two groups syncope and near-syncope concerning type and     frequency of adverse events. Furthermore we analyzed the routinely measured cardiac     biomarkers NT-proBNP and hs cTnT in patients with syncope or near-syncope. Then we determined     both their prognostic accuracy in predicting adverse events and their diagnostic accuracy in     finding the underlying etiology. Finally we analyzed a special patient collective, patients     aged ≥ 65 years. It is assumed that elderly patients are suffering from comorbidities and     age-related physiological and cognitive disabilities. We therefore hypothesize that elderly     patients, in contrast to patients aged < 60, display an increased risk of adverse events and     that they have a poorer prognosis.   "
104672|NCT01916057|"     The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG)     positron-emission tomography scan (PET scan) is useful for the therapy strategy of     hepatosplenic candidiasis.   "
104673|NCT01916044|"     The rate of caesarians dramatically increased for 15 years. The main indication of caesarian     became the iterative caesarian of principle because of a history of caesarian. Any attempt of     reduction of the rate of caesarians should thus focus on the indications of iterative     principal caesarean. Nevertheless, the main reason usually evoked to justify a reduction of     the attempts of low way after caesarian is the concern generated by the risk of uterine break     during the trial of labor. Yet, there is no reliable method to predict this risk of uterine     break. A way of interesting research consists in estimating the potential profits of the     echography of the scar lower segment. Indeed, the echography can be useful to determine the     specific risk of uterine break of a patient by measuring the thickness of the lower segment     of the womb.      The strong negative predictive value of the echography of the lower segment on the risk of     uterine break should encourage the women encircled to accept a trial of labor. That is why,     this examination associated with a rule of decision could help to decrease the rate of     iterative elective caesarians and especially to decrease the mortality and the foetal and     maternal morbidity connected to the trial of labor among the patients having a history of     caesarian.   "
104674|NCT01916031|"     The purpose of this study is to comparatively assess the effectiveness of a tailored     educational intervention to improve health literacy levels regarding upper respiratory     infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino     households in Early Head Start.   "
104726|NCT01915355|"     The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser     for the treatment of onychomycosis, or nail fungus.      Hypothesis: Complete nail clearance will occur in approximately half of patients after 3     laser treatments.   "
105961|NCT01899105|"     This study is designed to investigate the effect of food on the relative bioavailability of 2     different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet     formulations.   "
104675|NCT01916018|"     Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This     condition is detected consistently since the late 1970s in France, which has led to early     care and a significant improvement in prognosis and intellectual stature of these children.     However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases     have been reported in approximately 10% of cases. These observations are in most cases poorly     understood. The family nature of the CH is now well recognized and a dozen genes involved up     to now. However, in the majority of cases (HC not due to a disorder of the organification of     iodine), few mutations have been found in the reported number of patients (5-10%), suggesting     the involvement of other genes. Some of the genes have been implicated in particular specific     syndromic forms but many pathological associations remain unexplained. Also, a more complete     genetic elucidation of CH would enable a better understanding of its etiology and thus its     risk of familial recurrence (frequently asked questions by parents of children with CH) and     secondly the presence of associated pathologies.      Main goal: to describe the population with CH (not due to a disorder of the organification of     iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on     the genetic level to establish a genotype / phenotype correlation.   "
104676|NCT01916005|"     The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases,     initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a     decreased diagnostic accuracy for the modified Duke criteria.      Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron     emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.      Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou     European Hospital, Paris), the investigators plan to include consecutive patients suspected     of having PVE. All of the patients will be subjected to clinical, microbiological, and     echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data     analysis will be based on visual interpretation and quantitative measurement of FDG uptake     (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological     modified Duke criteria determined during a 3-month follow-up (gold standard).   "
104688|NCT01915849|"     The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption     immediately after a single dose (immediate effect) and 6 hours following the dose (after     multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).   "
104689|NCT01915836|"     The purpose of this study is to test a web-based video game to help cancer patients quit     smoking. The investigators are interested in what participants like and do not like about the     game.   "
104690|NCT01915823|"     The purpose of this study is to determine if Dymista nasal spray is better and safer than     placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.   "
104691|NCT01915810|"     The goal of this research study is to better understand if taking part in physical activity     might help smokers quit.   "
104692|NCT01915797|"     The overall project goal is to build a database of childhood cancers associated with     developmental anomalies; it aims at identifying new syndromes of genetic predisposition and     at enabling the further study of their molecular basis.   "
104693|NCT01915784|"     Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with     COPD   "
104677|NCT01915992|"     The NK cells participate in the innate immunity against infectious agents or transformed     cells that are recognized as no self by the absent, weak or abnormal expression of human     leukocyte antigen (HLA) class I molecules. According to the missing self hypothesis, a     negative signal is delivered to NK cells when their inhibitory receptors are engaged by the     specific HLA class I molecules. NK activation requires a positive signal delivered by the     engagement of activating receptors, more particularly of the Natural cytotoxicity receptors     or NCRs who are directly involved in the natural cytotoxicity of Natural Killer. The     activating receptors include NKp46, NKp44 and NKp30, also called NCR 1, 2 and 3 respectively.     NKp46 and NKp30 are constitutively expressed on the surface of the NK, the expression of     NKp44 is observed only after activation of cells NK. NK cells from most (80%) healthy donors     express a high quantity of NCR on their surface, corresponding to the NCRbright phenotype     while only 20 % present the NCRdull phenotype. In sharp contrast, most patients (80%) having     leukaemia have the NCRdull while only 20 % patients have the NCRbright phenotype. The culture     of NK from healthy donors ( NCRbright) with leukaemic cells result in decreased expression of     the NKp30 while there is no difference on expression if these same NK are cultivated with     cells from healthy donors. Moreover, study of AML patients showed that the NCRdull phenotype     was acquired during leukemia development because it was observed its complete (for NKp46) or     partial (for NKp30) reversibility in patients achieving complete remission (CR).     Reversibility of the NCRdull phenotype after CR suggested that leukemia cells might be     involved in NCR down-regulation. In line with these observations, we aim to study the     mechanism of NCR down-regulation by cultivating NK NCRbright from healthy donors with     leukaemic cells or healthy haematopoietic cells, in order to observe the appearance of the     NCRdull phenotype and verify by qPCR if this down-regulation is transcriptionnal. If this     hypothesis is be verified, we will study the regulation of NCR by focusing on the implication     of genes NCR transcription factors via bio-informatic analysis of putative transcription     factors fixation sequences in the promoters of these genes, followed by the verification of     the capacity of identified sequences to bind transcription factors. Ultimately, we will     verify the real implications of these transcription factors by studying the effect of their     silencing by RNA interference experiments.   "
104678|NCT01915979|"     The overall objective of the study is to assess the effectiveness of the treatment of     degenerative rotator cuff tendinopathy using the application of plasma rich in growth factors     (PRGF).      Main objective:      To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the     reference test of more than 15% compared to the treatment with corticosteroids.      Secondary objective:        -  To assess the efficacy of the treatment after 12 months.        -  Quantification of platelet levels in patients treated with plasma rich in growth factors          and its correlation with the clinical effect.   "
104679|NCT01915966|"     Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your     mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing     their quality of life and comfort. Usual recommendations in these patients are good oral     hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad     libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other     xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine)     are less used in terminally ill patients due to cost and secondary effects.      The purpose of this randomized parallel clinical trial is to determine if a new recipe of     gelatin with orange juice, cardamome and ginger is more effective in the control of     xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments     will be consumed ad libitum during one week. The main outcome is the subjective assessment of     dry mouth at end of treatment.   "
104680|NCT01915953|"     The purpose of the study is to define the precision, accuracy and variability of the NBM-200     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.   "
104682|NCT01915927|"     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer     using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of     20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated     perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard     adjuvant therapy including drainage of infection and placement of a draining seton with     continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining     seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per     current clinical practice. The subjects will be subsequently followed for fistula response     and closure for 24 months. This is an autologous product derived from the patient and used     only for the same patient.   "
104683|NCT01915914|"     This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE,     MAINTENANCE and FOLLOW-UP.      Subjects will complete the SCREENING phase to check the eligibility within 7 days after they     sign the written informed consent form. All eligible subjects will be enrolled in ACUTE phase     to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The efficacy     and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until Treatment     Success which depends on which time point comes first. Then subject can get into the     MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily twice     a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The treatment     duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in MAINTENANCE     phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that depends on which     time point comes first. If subjects don't experience relapse during MAINTENANCE phase,     subsequent FOLLOW-UP phase applying emollient twice daily won't be longer than another 12     weeks.      Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up to     4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After     randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly     plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites     (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase,     all subjects apply emollient twice daily up to 12 weeks.      This study will enrol 120 subjects, and propose at least 80 subjects to be randomized.      Study Endpoints/Assessments:      Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE     phase.      Secondary endpoints are:        1. Median time to the first relapse of AD during the whole study (including maintenance          phase and follow-up phase.        2. Numbers of recurrent patients at the end of MAINTENANCE phase;        3. Numbers of recurrent patients at the end of FOLLOW-UP phase;        4. The effective rates (proportion of treatment success patients) during ACUTE phase (V3,          W-2±2days;V4, W0±2days )        5. Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase,          FOLLOW-UP phase respectively);        6. Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening /          lichenification and abnormal pigmentation changes during the whole study duration (ACUTE          phase, MAINTENANCE phase, FOLLOW-UP phase respectively);        7. The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase;        8. The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase;        9. Subjects' post-study evaluation to drugs.   "
104684|NCT01915901|"     The primary objective of the study is to determine the effect of bismuth subsalicylate     (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in     healthy volunteers receiving TECFIDERA™ (dimethyl fumarate [DMF]; also known as BG00012)     twice daily (BID) The secondary objectives of this study in this study population are: To     characterize the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on the     frequency, severity, and duration of GI-related events and to evaluate GI-related events that     lead to discontinuation of DMF.   "
104685|NCT01915888|"     This study aims to estimate the clinical and cost impact of Rotarix vaccinations among     children aged less than 5 years using insurance claims data from commercial plans and     Medicaid low-income population. The impact of incomplete and complete Rotarix vaccination     will also be examined, overall and stratified by calendar time of Rotarix vaccination (e.g.,     2008 onward).   "
104694|NCT01915771|"     Objectives:      To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule     doses of 20 mg lomitapide.   "
104695|NCT01915758|"     This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase     I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design     consisted of the following periods: screening, induction, rest, challenge, and rechallenge     (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study     expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive     repeated 24-hour study patch applications; after patch removal, the sites were irradiated     with ultraviolet B light (UVB) and visible light (VIS) during the induction period     (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS     during the challenge and rechallenge periods. Each application site was observed     approximately 1, 24, 48, and 72 hours later for signs of inflammation.   "
104696|NCT01915745|"     The purpose of the study is to show that the standardized sending of SMS improve the bone     mineral density (BMD) screening of patients seen in the Emergency department for low trauma     fracture.   "
104697|NCT01915732|"     This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the     efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in     the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will     be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45     years of age, inclusive, at the time of consent, who have mild to moderate facial acne     vulgaris.      Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate     gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will     be evaluated for change in lesion counts, investigator's static global assessment (ISGA),     subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and     12 (or at early withdrawal). In addition, quality of life measures will be performed at every     study visit.   "
104698|NCT01915719|"     Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy     only, for immuno-compromized patients with acute respiratory failure   "
104699|NCT01915706|"     The purpose of this study is to compare the post-operative complication rates and surgical     outcomes in patients with a Baerveldt 350 implant following scheduled rip-cord removal in     clinic at post-operative week 3 versus spontaneous tube opening. Patients age 18 or greater     with uncontrolled glaucoma and scheduled to undergo their first superotemporal Baerveldt 350     implant will be recruited and randomized at the time of enrollment to either scheduled     ripcord removal at post-operative week 3 or no ripcord removal. Incidence of complications     will be documented and compared between the 2 groups. The final intraocular pressure control     between the 2 groups will also be compared in a secondary outcome analysis. This study will     help to establish post-operative management guidelines to minimize complications and improve     intraocular pressure lowering success following Baerveldt 350 implantation.   "
104747|NCT01915082|"     This study investigates possible beneficial effects of peri-operative treatment (i.e.     pre-transplant initiation and prompt post-transplant continuation) with azithromycin in lung     transplantation. Our hypothesis is that this therapy will improve early allograft function     and outcome following human lung transplantation.   "
104858|NCT01913613|"     The objective of this clinical study is to evaluate the safety and performance of the IASD     System II in the treatment of heart failure patients with elevated left atrial pressure, who     remain symptomatic despite appropriate medical management.   "
104700|NCT01915693|"     The single most distressing symptom for more than 70% of patients with oesophageal cancer is     difficulty in swallowing (dysphagia) caused by blockage of the gullet by a tumour. This     causes severe restrictions on food intake, physical activity, social functioning and overall     quality of life. Amongst the more effective treatments for improving swallowing, is the     insertion of a metal stent across the blocked part, which then self-expands to open up the     gullet (Self Expanding Metal Stent or SEMS). The addition of radiotherapy may help to improve     the problems caused by dysphagia and provide an additional survival benefit.      The purpose of this study is to test the impact of adding radiotherapy to SEMS on:        -  the length of time swallow remains improved for        -  quality of life        -  survival   "
104701|NCT01915680|"     The purpose of the study is to investigate the IOP difference between normal and glaucomatous     eyes using standard ophthalmic tonometry devices while subjects are performing different     standard yoga asanas. The IOP of participants will be measured prior, immediately at start of     the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The     patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be     tested.   "
104702|NCT01915667|"     The purpose of the study is to evaluate the amount of compound present in the blood (relative     bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in     fasted conditions in male healthy subjects.      Also, the effect of food on the bioavailability of the tablet formulation will be studied as     well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule     or tablet.   "
104703|NCT01915654|"     The purpose of the transfusion of packed red blood cell is to overcome acute or chronic     anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase     oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field     particularly favorable to the development of tissue hypoxia, which is associated with     increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues     at the preoperative period is accompanied by a significant reduction of these major     complications.      Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood     cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious     effect of transfusion, especially in patients with poor condition, related to storage time.     Indeed, during storage, impaired blood-related storage is created. It is metabolic,     biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery     where patients are suitable for transfusion RBC, have focused on the effect of transfusions     on consumption and the transport of oxygen to demonstrate the impact of conservation lesions     on their role in vivo. In particular, a single-center retrospective American study showed     reduction of postoperative complications in patients who received RBC under 14 days.      However one of the confounding factors present is that all transfused RBCs are not     leukoreduced (unlike the French transfusion policy). In addition, the greater part of the     clinical studies are controversial. That is why we aim to assess, through a retrospective     study of data, the impact of transfusion of red red blood cells within 14 days of     post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac     surgery patients.   "
104704|NCT01915641|"     We have reported that CPAP treatment improved the walking capacity of overlap syndrome     patients.      However, the previous study was not randomized, double blinded study. Therefore, we design a     prospective, randomized, double blinded, controlled, cross-over trial to confirm this     finding.   "
104706|NCT01915615|"     Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease and the most     frequent cause of sudden cardiac death (SCD) in the young. It is characterized by unexplained     left ventricular hypertrophy (LVH), diffuse and patchy fibrosis, and myofibrillar disarray.     While the majority of patients remain asymptomatic, prognosis is poor in a subset who present     with SCD or progress to heart failure (HF). Current methods to predict risk of these adverse     events and to target therapy are limited. Current medical therapy does not protect against     SCD, nor does it prevent development of HF. Therefore, the identification of novel risk     markers would help develop therapeutic targets aimed at altering the phenotypic expression to     impact the natural history, especially SCD and HF. Cardiovascular magnetic resonance (CMR) is     emerging as a powerful tool for diagnosis and risk stratification in HCM including assessment     of LV mass and pattern of hypertrophy. Late gadolinium enhancement by CMR is a marker of     focal myocardial fibrosis which is thought to underlie the arrhythmogenic substrate as well     as promote development of HF. The investigators hypothesize that HCM patients with a higher     primary outcome event rate can be identified by novel CMR findings. The majority of cases of     HCM are autosomal dominant and about 60% are caused by mutations in genes encoding cardiac     sarcomeric proteins. However, the relationship between genetic mutation, disease phenotype,     and clinical outcomes remains poorly understood. The investigators hypothesize that HCM     patients with sarcomeric HCM mutations will have a higher primary outcome event rate and more     marked myocardial pathology on CMR than those without. Furthermore, there may be a link     between sarcomeric mutations and fibrosis, as mutation carriers with overt HCM as well as     those without hypertrophy have elevated markers of collagen turnover. The investigators     therefore hypothesize that serum biomarkers of collagen metabolism in HCM will predict     outcomes. Thus, the Specific Aim is to develop a predictive model of cardiovascular outcomes     in HCM by: 1) using exploratory data mining methods to identify demographic, clinical, and     novel CMR, genetic and biomarker variables associated with the outcomes and 2) develop a     score from the predictive model that can be used to assess risk given a patient's combination     of risk factors, thus establishing the evidence base to enable clinical trial design to     reduce morbidity and mortality in HCM in a cost-effective manner.   "
104707|NCT01915602|"     This is a study to investigate the potential clinical benefit of refametinib when given in     combination with sorafenib as first line treatment in patients with unresectable or     metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages.     Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to     receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15     patients at Stage 1 show at least partial response according to an objective criteria to     evaluate tumor size based on contrast enhancement [modified response evaluation criteria in     solid tumors (mRECIST)] assessed by external independent radiologists.      Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor     targets certain key proteins that are essential for the survival of the cancer cell. By     specifically targeting these proteins, refametinib in combination with sorafenib may stop     cancer growth. The growth of the tumor may be decreased by preventing these specific proteins     from functioning.      The primary endpoint (the most meaningful result to be tracked) of this study is based on the     rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with     refametinib in combination with sorafenib improves the response rate in this patient     population compared to historical results observed with the sorafenib only.   "
104756|NCT01914965|"     The influence of bupropion compared to placebo on the change of apathy as quantified by the     apathy evaluation scale (AES-I, where I [informant] is a friend or family member familiar     with the daily activities of the subject) in patients with HD after ten (10) weeks of     treatment.   "
104708|NCT01915589|"     This is a study to investigate the potential clinical benefit of refametinib in patients with     unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2     stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this     study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of     15 patients at Stage 1 show at least confirmed partial response (PR) according to modified     response evaluation criteria in solid tumors (mRECIST) assessed by central image review.      Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor     targets certain key proteins that are essential for the survival of the cancer cell. By     specifically targeting these proteins, refametinib may stop cancer growth. The growth of the     tumor may be decreased by preventing these specific proteins from functioning.      The primary endpoint (the most meaningful result to be tracked) of this study is based on the     rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with     refametinib improves the response rate in this RAS mutation patient population.   "
104709|NCT01915576|"     This is the first study where BAY1125976 is given to humans. Patients (all comers) will     receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine     the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative     bioavailability of liquid service formulation and tablets will be determined.      After the MTD is defined breast cancer patients with and without AKT1 mutation will be     treated.      The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters     and tumor response of BAY1125976.      BAY1125976 will be given daily as single oral application. Treatment will be stopped if the     tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the     patient decides to exit treatment.   "
104710|NCT01915563|"     To evaluate if a rest period before extubation after a successful SBT trial could reduce the     extubation failure rate.   "
104711|NCT01915550|"     Adding metformin to insulin therapy in pregnant women with diabetes mellitus who show insulin     resistance may be equivalently effective to further raising the insulin dose   "
104712|NCT01915537|"     A prospective, multi-centric, cohort study to observe the efficacy difference between     intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever     rheumatoid arthritis(RA) 28 joints disease activity score>5.1(DAS28>5.1) patients with poor     prognostic factors.Primary objective is compare the difference of clinical remission rate     between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor     prognostic factors at week 30.   "
104713|NCT01915524|"     The purpose of this study is to determine whether the new RNActive derived lung cancer     vaccine CV9202 in combination with local radiation therapy is safe, tolerable and immunogenic     for the consolidation and maintenance treatment of stage IV non small cell lung cancer     (NSCLC) after first-line chemotherapy or therapy with an EGFR tyrosine kinase inhibitor.   "
104714|NCT01915511|"     This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic     Pulmonary Fibrosis (IPF) and the treatment and management efforts applied throughout study     follow-up, clinical outcome events and patient reported outcome data. Blood samples will be     collected periodically throughout the study for use in future research efforts.   "
104715|NCT01915498|"     Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD,     and clinical activity evaluation of orally administered AG-221 in subjects with advanced     hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation     phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose     (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical     activity of AG-221 in select populations.   "
104717|NCT01915472|"     This is a Phase II trial to study the safety and efficacy of IMMU-130. IMMU-130 is composed     of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a     common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by     the immune system. They bind to substances that don't belong in the body to prevent harm to     the body. The antibody in this study was designed to bind to a marker located on colorectal     cancer tumors. The antibody was originally made from mouse proteins, but was changed in the     laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts     for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is     safe and effective.   "
104718|NCT01915459|"     The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to     Botox® reducing upper limb muscle tone in post stroke patients.   "
104719|NCT01915446|"     This study aims to investigate the predictive value of novel biomarkers and contrast-enhanced     ultrasonography for early detection of abdominal end-organ (kidney and intestinum)     hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for     aortic aneurysm or dissection. In this context, patients will be monitored for renal     biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid     binding protein (i-FABP)) and local tissue perfusion will be assessed using contrast-enhanced     ultrasonography (CEUS).      The ultimate goal of this study is an early identification of patients developing one or both     of these complications, which may facilitate a timely intervention to improve outcome.   "
104720|NCT01915433|"     Based on favorable preliminary data from ongoing studies testing the safety and tolerability     of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the     investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet     intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus     Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life     scores as measured by fatigue severity scale score and MS quality of life 54 physical and     mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and     the diagnosis secondary and primary progressive MS, progressive relapsing MS or     relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or     greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls     diet (modified paleolithic diet) groups will be instructed in completing a daily food log and     receive coaching from registered dieticians who are expert in motivational interviewing. The     control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and     inflammation, blood sugar and insulin levels will be monitored. Additional blood will be     frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed     using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will     be done at baseline and 12 weeks. Outcome measures will be change in quality of life and     fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12     weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue     and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that     the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups     will experience more improvements in quality of life and reduced fatigue and in biomarkers     than the usual care group experiences at 12 weeks. The usual care group will be given     instruction in following both the wahls paleo plus and the wahls diet plans and how to     utilize the daily food logs at the end of study visit. The usual care group will receive one     nutrition coaching call to assist with implementation of the study diet.   "
104727|NCT01915342|"     The overall aim of the proposed study is to determine optimal parameter of focal muscle     vibration for improving spasticity and identify neurophysiological mechanism in healthy     subjects.      In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz     frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity,     H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be     recorded pre, during, and post vibration.      In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm     amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre,     during, and post vibration.      In investigation II, subjects will undergo focal muscle vibration with predetermined     parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor     evoked potential at mGCM will be recorded pre, during, and post vibration.   "
104728|NCT01915329|"     The purpose of this study is to test a specific nerve stimulation protocol as therapeutic     option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper     extremity.   "
104729|NCT01915316|"     The purposes of this study are to: i) confirm and improve the accuracy of the correlation     between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as     determined through pathology; and ii) determine the levels of zinc in prostate tissue     declared as non-cancerous by pathology and located in the vicinity of tissue declared as     cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous tissue     are lower (statistically significantly) than the levels for benign tissue not in the vicinity     of cancerous tissue.   "
104730|NCT01915303|"     This study is to assess whether pasireotide alone and combined with cabergoline will give     reliefs on patients with recurrent, persistent and newly diagnosed Cushing's disease. The     study will also assess study drug safety, the changes in Quality of Life and on clinical     signs and symptoms of Cushing's disease.   "
139669|NCT01456546|"     The aim of this study is to investigate if the genetic variant CYP2C19*17 affects the     pharmacokinetics of proguanil and clopidogrel.   "
104732|NCT01915277|"     The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine     (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants     undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for     congenital cardiac problems. This study will also design and validate a dosing schema for the     use of DEX as described above.   "
104733|NCT01915264|"     The study is designed as non interventional to collect data on the safety especially, severe     hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of     acarbose/metformin fixed-dose combination under real-life treatment condition in large sample     of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia     or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The     study will begin after the study approval by ethics committee. All patients with type 2     diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in     study after taking the informed consent. Patients will be observed for up to 24 weeks (2     weeks).The study involves general examination of patients, collection of data like history of     disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects     from multiple study centers spread across India. The study data will be analyzed with     appropriate statistical methods.   "
104734|NCT01915251|"     Background:      - Vaginal yeast infections are caused by a fungus called Candida. Candida can live harmlessly     in the vagina, but most women will have symptoms from a vaginal yeast infection at some point     during their life. Antibiotics increase the risk for yeast infections, but it is unclear why.     They may disrupt the balance of healthy bacteria in the vagina. This could make it harder for     the body to fight off yeast infections. Researchers will give healthy women a common     antibiotic or a placebo. They will study how the antibiotic affects bacteria and yeast in the     vagina and other parts of the body. This will let researchers study the normal changes of     healthy bacteria and yeast over time.      Objectives:      - To see how the study drug changes healthy bacteria in the vagina, and how these changes may     increase the risk for yeast infections.      Eligibility:      - Healthy women ages 18 to 40 who are not allergic to penicillin.      Design:        -  Participants will be screened with medical history, physical exam (including vaginal          exam), blood tests and tests for sexually transmitted diseases.        -  Participants must take birth control pills for at least 3 months before, and during the          study.        -  Participants will take the study antibiotic or placebo for 10 days.        -  Participants will have 7 study visits over 3 months. Visits will be timed around          participants menstrual cycles.        -  At the visits, participants will answer questions about their health and undergo tests.          These may include swabs of the vagina, mouth and skin as well as blood tests. Vaginal          fluid, saliva and urine will also be collected.        -  Between visits, participants will collect stool and vaginal samples at home and bring          them to the next clinic visit.   "
104736|NCT01915225|"     Background:      - Recent advances in cancer research have led to new therapies to treat the disease. It is     important to continue these advances and discover new ones. To do that, researchers need     tissue samples from solid tumors. This study will collect such samples from people already     scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).      Objectives:      - To collect tissue samples for use in studying new ways to treat tumors.      Eligibility:      - Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled     to have surgery or a biopsy at the NIHCC.      Design:        -  Before their procedure, participants will have a small blood sample taken.        -  Some participants will undergo leukapheresis. In this procedure, blood is removed          through a tube in one arm and circulated through a machine that removes white blood          cells. The blood, minus the white blood cells, is returned through a tube in the other          arm. The procedure takes 3 4 hours.        -  For all participants, during the surgery or biopsy, pieces of the tumor and pieces of          normal tissue near it will be removed for this study. The rest of the tumor or          precancerous growth will be sent to a lab for analysis.        -  Participants will return to the clinic about 6 weeks after the operation for a routine          checkup. Some may have to return for additional follow-up.   "
105903|NCT01899859|"     The primary objective of this study is to characterize the safety, tolerability and     dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with     biopsy-proven NASH with advanced liver fibrosis.   "
104755|NCT01914978|"     The objective of this research is to evaluate the effectiveness of a handbook for parents of     children newly diagnosed with food allergy. The handbook was developed to provide information     and strategies to support families in effectively managing food allergies while maintaining     positive quality of life. Parents of children newly diagnosed with food allergy (within the     past year) will be randomized into either the treatment condition (handbook) or a control     condition (management of food allergy as usual). Participants will complete study     questionnaires online at three time points: baseline (this will be before receiving the     handbook for the treatment group), post-intervention (2-3 weeks after baseline), and     follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome     measures and satisfaction with the handbook. Parents in the control group will receive the     handbook following the conclusion of their participation in the study.   "
104959|NCT01912287|"     The purpose of this randomized study is to examine the comparative efficacy of yoga,     cognitive behavioral therapy, and stress education, a previously employed control condition,     for patients with Generalized Anxiety Disorder.   "
104737|NCT01915212|"     Background:      - Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause     serious infection in newborns and in people with weakened immune systems. It increases the     risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine     that could prevent genital herpes could improve the general health of the world s population.     Researchers want to study whether a new vaccine, HSV529, which may be used in the future to     prevent herpes infections, is safe.      Objectives:      - To test whether a new herpes vaccine is safe.      Eligibility:      - Healthy adults 18 40 years old.      Design:        -  Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone          calls over 1 year.        -  Each vaccination visit will last about 4 hours.        -  Participants will be screened with a medical history and physical exam.        -  Participants will have a blood sample taken.        -  Participants will be given the vaccine or a placebo, by injection from a needle. They          will be monitored for 30 minutes to check for any allergic reaction.        -  Participants will be given a diary card to record any symptoms they may feel later.        -  At follow-up visits, participants will give a blood sample and answer health questions.        -  In the phone calls, participants will answer health questions.   "
104738|NCT01915199|"     The implementation of lifestyle modifications, home blood pressure (BP) measurement, and     optimization of antihypertensive drug therapy have been shown to improve BP control in     tightly controlled research settings. The investigators objective is to determine the effect     of these interventions in a primary care setting, with the family practitioners and nurses     serving as the interventionists. The investigaotrs hypothesis is that a comprehensive     intervention performed in a primary care setting would lead to better blood pressure control.   "
104739|NCT01915186|"     The aim of the study is to evaluate the effect of DHEA supplement on ovarian reserve markers,     ovarian response to gonadotrophins and cycle outcomes in patients with normal and poor     ovarian reserve.      Study Hypotheses:        1. DHEA supplementation would improve markers of ovarian reserve and ovarian response to          low dose FSH stimulation in both normal and poor responders        2. DHEA supplementation would improve IVF cycle outcomes   "
104740|NCT01915173|"     The purpose of this study is to investigate the effects of a widely available over the     counter supplement marketed for heartburn symptoms on symptoms and health-related quality of     life in patients with gastroesophageal reflux disease (GERD). This study is designed as a     pilot trial to assess safety and feasibility and to provide preliminary estimates of effect     sizes.   "
104741|NCT01915160|"     Nearly 9 million U.S. children (1 in 8) meet criteria for at least one mental health disorder     at any point in time. Effective treatments exist for these disorders, but children and     families who seek services rarely receive them; mental health providers need more support in     the delivery of these interventions to ensure that children and families are receiving the     best quality care. This project aims to improve the delivery of best practices for families     who seek mental health care by developing creative, technology-based resources for providers.     Once we have completed development of the tablet-based resources, we will conduct a small     randomized study with 20 families to examine the feasibility and prepare for a large study to     test the effectiveness of the resources.   "
104742|NCT01915147|"     The study is intended to explore changes in the composition and quantity of gut bacteria     subject to treatment with strong pain medication. Two pain medications will be compared (OXN     PR and OxyPR). Other gastrointestinal parameters will be assessed.   "
104743|NCT01915134|"     The investigators designed this study to evaluate the efficiency and the acute toxicities of     recombinant human endostatin (endostar) combined with chemotherapy in the metastatic     nasopharyngeal carcinoma (NPC).   "
104744|NCT01915121|"     The study main objectives are to enhance treatment decision making and improve quality of     life and post-treatment health care among patients diagnosed with invasive bladder cancer.      Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more     common among men than women and 90% of all patients are over the age of 55. Surgery to remove     the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent     reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The     emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients'     QOL and adjustment can be devastating. This impact significantly varies by treatment option.     Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a     number of cognitive and affective factors (e.g., patients' emotional reaction, values, and     expectations). Thus, in addition to adjusting to a potential life-threatening disease, having     to cope with uncertainty about the efficacy and outcomes of different treatment options adds     to the overall distress and may impair effective decision-making. In spite of increasing     efforts in health communication and patient education, no study has examined treatment     decision making among invasive bladder patients or has provided an educational intervention     to facilitate treatment decision making among this population. To this end, and guided by the     Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in     decision making, we have designed and pilot tested the acceptability of a preliminary     educational and training experiential intervention (ETE) to address this gap in the     literature. The ETE intervention uses new and innovative educational strategies and methods     to educate patients about their treatment options and to facilitate their treatment decision     making.   "
104745|NCT01915108|"     This study was designed to determine the optimal dose of remifentanil that can prevent the     complications associated with the removal of LMA without delaying emergence.   "
104746|NCT01915095|"     The goals of this study are to examine the physiology of Central Nervous System pathways     contributing to the control of upper and lower extremity movements after SCI, and to promote     the recovery of extremity movements by using non-invasive brain stimulation and motor     training.   "
104776|NCT01914705|"     The objective of the study is to investigate whether or not there will be a significant     difference between landmark vs. ultrasound guided approach during Subclavian Central Venous     Catheter (SCVC) placement in terms of the success rate, the time it takes to perform the     procedure and the complication rate. By using ultrasound to identify anatomical structures     that are not seen during the landmark approach, the investigators hypothesize that both the     procedural time and the complication rate of ultrasound guided approach should be lower than     the landmark approach. The investigators hypothesize that the success rate will be higher in     the ultrasound group.   "
104748|NCT01915069|"     Combined oral contraceptive pills (COCs) are the most commonly used hormonal form of birth     control in the United States with at least 87% of women of reproductive age reporting oral     contraceptive use at some point in their lives (9). Despite their frequent use, the six and     twelve month discontinuation rates for oral contraceptive pills are 31 and 47 % respectively     (17), with common reasons for discontinuation attributed to the side effects of abnormal     bleeding, headache, and weight gain.      Additionally, COCs are contraindicated in certain groups of women as outlined by The Centers     for Disease Control Medical Eligibility Criteria (11). Given the high prevalence of oral     contraceptive users who commonly discontinue use secondary to side effects or who are not     eligible for use as a result of underlying health conditions, the development of novel oral     non-hormonal methods that are equally effective at pregnancy prevention are warranted.      This current study aims to evaluate the effect of an FDA approved drug, Cilostazol, on human     oocyte maturation. Such a study has not been conducted to date. If Cilostazol demonstrates an     ability in humans to affect resumption of meiosis, then this non-hormonal agent could be uses     as a possible contraceptive agent in the future. This knowledge would have profound     reproductive health implications.      The investigators propose that women undergoing treatment with the FDA approved dose of 100mg     PO every 12 hours of Cilostazol will demonstrate an impairment of egg maturation in     comparison to paired historic controls following ovarian follicle stimulation.   "
104749|NCT01915056|"     The purpose of this study is to determine whether information regarding GA and GA-driven     interventions improves outcomes in older cancer patients receiving first-line or second-line     chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and     early termination of treatment in patients with and without GA-driven interventions. The     investigators will identify information that will be useful based on questionnaire responses     and blood tests. These results will be used to better understand which recommendations and     interventions will benefit older cancer patients. It is our hope that these tools, which are     well-established at identifying areas of risk, will provide meaningful opportunities for     intervention to promote your safety during cancer management. The investigators will be able     to use this information to teach others on how to best care for adults aged 70 and older with     cancer.   "
104750|NCT01915043|"     Background: The cancer-related lymphedema (BCRL) is the abnormal accumulation of fluid in the     lymphatic system and can develop immediately after surgery / radiotherapy of breast cancer,     or may appear months later. In the literature there are numerous educational recommendations     to avoid the appearance BCRL, but there is a lack of adherence to these recommendations. With     the increase of mobile technologies among adults, the mobile devices can be an effective     method to meet their education.      Objective: To determine the effectiveness of therapeutic adherence a brief educational     intervention through a smartphone-based application in the prevention of lymphedema in women     with mastectomies.      Method: 100 women survivors of breast cancer will be randomized to a group that will receive     lymphedema prevention education and an app specific for better adhesion compared to the     control group will receive education only. They will be monitored for 28 weeks by specific     measures of lymphedema onset, volume and perimeter arm and hand strength lymphedema     disability questionnaire and other measures of fatigue, quality of life and mood related to     cancer.      Discussion: The lack of adherence to health education is the main cause of failure in     maintaining these brief educational interventions, whether the program is beneficial, it     could be successfully implemented in clinical practice.   "
104751|NCT01915030|"     The present study is designed to investigate whether a high protein diet will preserve muscle     mass during caloric restriction in older adults.   "
104752|NCT01915017|"     Many individuals with schizophrenia continue to hear voices, have false beliefs, and problems     with attention, memory planning and everyday functioning even with medication treatment. The     process of recovery in schizophrenia involves treating the whole person. This study will test     a new Multimodal Cognitive Treatment (Mcog). Mcog works around problems in attention, memory     and planning by using supports in the home such as signs, checklists, and alarms to improve     everyday functioning. Mcog also helps the individual to examine the evidence for their     beliefs and to deal with symptoms like voices that are not completely resolved with     medications. We will compare 4 treatments to determine if this combined approach improves     both symptoms and functioning for individuals with schizophrenia.   "
104753|NCT01915004|"     Children with non-neurogenic lower urinary tract dysfunction (NLUTD) represent a significant     subgroup of pediatric urology patients, comprising up to 30 percent of some out-patient     clinics. These children present with urinary tract infections (UTIs), abnormal voiding habits     and various other lower urinary tract symptoms (LUTs) such as incontinence, urinary urgency     and urinary frequency. Furthermore, the effects of NLUTD on a child's physical health, mental     health and its potential negative clinical sequelae, which includes upper or lower urinary     tract damage, must be taken into account when treating these children. These patients have     complex needs requiring a significant amount of health teaching and it is imperative to     determine the effectiveness of the various modes of delivering urotherapy. To determine the     best modality to deliver urotherapy, this trial will compare the effectiveness of a 7 minute     bladder training video to the effectiveness of standard urotherapy provided at a pediatric     urology clinic at improving NLUTD/DES symptoms and quality of life in children between 5-10     years of age.   "
104787|NCT01914562|"     This is an open label, randomized, balanced, single center, single dose, trial to assess the     pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted     condition) and following a high fat, high calorie meal (fed condition) in a 2-period,     2-sequence, crossover manner.   "
104788|NCT01914549|"     Use of dipole density mapping to identify activation in complex supraventricular tachycardias   "
104754|NCT01914991|"     Study Design: Randomized controlled clinical study. Introduction: Physiotherapeutic     intervention aiming to restore mobility using different techniques as stretching, hot packs,     exercises, therapeutic ultrasound and orthotics. No scientific evidence has been found     correlating improved joint mobility and the use of these techniques. Application techniques     of orthoses to reshape the soft tissues have been well detailed, however, no scientific     evidence supporting their effectiveness on proximal interphalangeal joint (PIPJ) lag     extension resolution using them as a single treatment has been found.      Purpose of the Study: The purpose of the study was to test the effectiveness of static and     dynamic orthosis in patients with a PIPJ flexion retraction using them as a single treatment     compared with traditional combined therapies.      Method: 63 participants were included in the study. Patients who used splints were compared     to a control group who received conventional treatment. Active and passive mobility were     measured before the experiment and again three months after. All the patients were measured     under the same conditions and treated by the same hand therapist. The relationship between     contracture resolution and function was measured using the DASH Spanish Version.   "
104757|NCT01914952|"     The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate     (HMB) after the dietary supplement has been administered in different forms. Prior studies     have indicated that form of administration affects bioavailability of the HMB supplement.     Therefore the current study will examine the bioavailability of a single dose of HMB given     as:        -  1.0g CaHMB in gelatin capsule        -  0.8 g HMB free acid in a gelcap        -  0.8 g HMB free acid in water        -  1.0 g CaHMB in water        -  0.8 g HMB free acid      The randomized study will be a crossover design and each study subject will undergo the     experimental protocol for each of the supplementation forms. Because of the different     administration forms, the study will be an open label study. Briefly, the fasted participants     will report to the laboratory in the morning. After an initial blood sample is taken, the     dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25, 35, 45, 60,     90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine collection     will also be performed. Participants will be given a light sack lunch 4 h after     administration of the dosage and will remain at the laboratory through the 360 min sampling.     Participants will then be allowed to leave the laboratory and return for the 720 min sampling     after which the participants can eat an normal evening meal. Participants will return to the     laboratory fasted the next morning for the final sample. A minimum 48 h washout period will     be required before the next dosage form is administered and the process repeated.   "
104758|NCT01914939|"     This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin     (OT) augmentation, in young adults with autism spectrum disorders. Participants will be     randomly assigned to receive either a social skills-focused CBT intervention or a stress     management/relaxation training CBT intervention. Participants will also be randomized to     receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The     design of the study will enable examination of the efficacy of CBT for young adults with     autism spectrum disorders. The design of the study will also allow examination of whether     oxytocin enhances the efficacy of CBT.      The investigators will perform functional (fMRI) and structural (MRI) imaging with all     participants prior to treatment. This will enable examination of the relations between     measures of brain function and structure, and improvements in target symptoms over the course     of treatment. The aim is to discover whether there are neural characteristics that can     identify which participants with autism spectrum disorders are most likely to respond to CBT     interventions and/or oxytocin treatment.   "
104759|NCT01914926|"     Acute atrial fibrillation is the most common sustained, clinically significant dysrhythmia     encountered in the emergency department (ED) and the most common dysrhythmia treated by     emergency physicians. Atrial flutter is less common than atrial fibrillation but its     management in the ED is very similar, and the majority of patients with atrial flutter also     have atrial fibrillation. Symptomatic relief and ventricular rate control are generally the     primary therapeutic objectives in the ED management of acute atrial fibrillation and flutter     (AFF). The need for swift, appropriate action by the emergency physician is highlighted by     the fact that up to 18% of patients with AFF develop potentially life-threatening     complications such as congestive heart failure, hypotension, ventricular ectopy, respiratory     failure, angina and myocardial infarction.      Both beta-blocking agents and calcium channel blockers are commonly used to treat AFF in the     ED. Metoprolol is the most commonly used beta-blocker; and diltiazem is the most frequently     used calcium channel antagonist.[8] Diltiazem was released by the FDA for treatment of AFF in     1992. Shreck et al. were the first to demonstrate both the efficacy of diltiazem in the ED     management of AFF with rapid rate and its clear superiority over the previously most commonly     used pharmacologic agent, digoxin.      To date, only one prospective, randomized trial has compared the effectiveness of a calcium     channel blocker (diltiazem) with a beta-blocker (metoprolol) for rate control of AFF in the     ED. Despite the relatively small sample size (n=20 in each group) the authors concluded that     both pharmacologic agents were similarly effective. In order to test this finding, the     investigators conducted a prospective comparison of metoprolol and diltiazem for the     management of patients presenting to the ED with AFF with rapid ventricular rate.   "
104760|NCT01914913|"     Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is     the layer of tissue at the back of the inner eye that converts light images to nerve signals     and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is     used for this condition .   "
104761|NCT01914900|"     This is a phase II study of preoperative chemotherapy with docetaxel, cisplatin and     5-fluorouracil (TPF) in locally advanced resectable oral cavity squamous cell cancer. The aim     is to improve the rate of pathological complete response to induction chemotherapy in a     molecular enriched population, consisting of patients with tumour harbouring a functional p53     protein and/or showing low expression of beta-tubulin II.   "
104762|NCT01914887|"     The aims of our study are to evaluate the feasibility and safety of endoscopic injection of     adipose tissue-derived mesenchymal stem cells in human subjects with moderate active     ulcerative colitis, assessing the absence of adverse events associated to the investigational     drug, and to evaluate the efficacy of the treatment to induce remission of moderate active     ulcerative colitis, by improvements in disease activity index, quality of life index, and     endoscopic index.   "
104763|NCT01914874|"     The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced     mindfulness-based program that includes mindful exposure to reduce anxiety and avoidance of     social situations, and the Buddhist practice of self-compassion aimed at reducing harsh     judgment and self-criticism that is characteristic of people with social anxiety disorder.   "
104764|NCT01914861|"     The purpose of this study is to examine a possible link between the time of day of exposure     to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and     biological correlates will also be examined from this perspective.   "
104765|NCT01914848|"     Multiprofessional Advance Care Planning and shared decision making for end of live care for     terminal patients and their relatives.      The aim of this study is to develop, implement and test a complex intervention for improving     patients' preparation for and participation in end of life decisions. In cooperation with     local, national and international partners, the investigators will focus on strategies to     enhance advance care planning and shared decision making on end of life issues, and     documentation and transferability of end of life decisions across health care settings in     coordinated approach involving patients, their families and care givers (in and out of     hospital).   "
104777|NCT01914692|"     Gastric cancer radical surgery related complications are common.Somatostatin is a     conventional medical therapy for bleeding.This study explore the effect of Somatostatin for     Advanced Gastric Cancer After D2 Lymph Node dissection.   "
104960|NCT01912274|"     The purpose of this study is to determine the safety and effectiveness of pracinostat when     combined with azacitadine for patients who are 65 years of age or older and have Acute     Myelogenous Leukemia (AML)   "
104766|NCT01914835|"     Cocaine/Crack Dependence has been associated with neuropsychological impairments mainly in     executive functions and decision-making, which are predominantly managed by the prefrontal     cortex (PFC) in the brain. However, none study in Neuropsychological Rehabilitation (NR) has     been done in order to remediate the executive functioning in this population. The aim of this     research is to investigate the impact of neuropsychological intervention based on the     stimulation of cognitive functions such as attention, planning, organization, logical     reasoning, executive functioning, and decision making. For this research it will be proposed     interventions through motivational strategies and board games, especially chess because it     has been associated with PFC functioning, since it is a game which requires complex cognitive     abilities, such as: inhibitory control, mental flexibility, sustained attention, future     planning and decision-making. There will be two groups of patients with cocaine/crack     dependence (n = 56), one with NR (group A, n = 28) and another without NR (group B, n = 28).     Group B will be submitted to the placebo intervention. Both groups will be submitted to an     extensive battery of neuropsychological tests and psychopathological rating scales before and     after interventions. A sub-group will also be submitted to functional magnetic resonance     imaging and biomarkers measures (BDNF and cortisol). The hypothesis is that group A will     present a pronounced improvement not only on the neuropsychological test but also on the PFC     functioning in neuropsychological functions compared to group B.   "
104767|NCT01914822|"     1. To examine whether Ritalin has analgesic properties in healthy subjects.        2. To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a          broader, non-specific effect on high mental functions.   "
104768|NCT01914809|"     Preeclampsia is a frequent pathology. His etiology is doubtful.      Targets :      The study target is to identify a risk of preeclampsia group obtained with transcriptom     analysis from circulating peripheric cells.      Design:      Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).      The study of the transcriptional history of peripheral blood cells of 2patients groups:        -  A patient group with a preeclampsia before 34 SA        -  A patient group with a normal pregnancy paired on main confusion factors. Blood sampling          will be collected at the diagnosis and 8 weeks after delivery.      Results and perspectives        -  Obtain a transcriptionnal signature of preeclampsia        -  To identify new mechanism of the disease        -  Identification of a specific transcriptom analysis with the comparison after delivery          For long-term, the target is to identify risk patient in order to conduct easily          preventive clinical trials in preeclamsia (primary prevention) and to consider a          specific follow-up for risk patients.   "
104769|NCT01914796|"     This study will determine the safety and tolerability of PF-06412562 given orally to healthy     volunteers. To determine the optimal dose for future studies, the concentration of the drug     over time will be determined by periodic blood samples. The rate of eye blinks will be     measured as an indicator of PF-06412562 action on the receptors of interest in the brain.   "
104770|NCT01914783|"     The primary hypothesis of the study is that in healthy elderly subjects experimental exposure     to air pollutants increases sympathetic nervous system activity compared with sham (clean     air) exposure. The secondary hypothesis of the study is that combined experimental exposure     to air pollutants (particles + ozone) increases sympathetic nervous system activity to a     greater extent than does the exposure to particles alone.   "
104771|NCT01914770|"     This pooled analysis will assess data from the Phase 3 belimumab registration studies     BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and     agreed prior to the unblinding of either study. The primary objective is to evaluate the     impact of belimumab treatment on a more severe subpopulation of systemic lupus erythematosus     (SLE) subjects from BLISS-52 and BLISS-76 to aid physicians and payers in decision making.     Subjects are from the modified Intent-to-Treat (ITT) population defined as randomized     subjects who received at least 1 dose of study agent. This more severe subpopulation will     have renal, neurological, haematological, or cardiovascular/respiratory organ domain     involvement (as defined by a British Isles Lupus Assessment Group (BILAG) domain score of A,     B or C in at least one of the domains) at baseline AND anti-double-stranded deoxyribonucleic     acid (anti-dsDNA) positive (≥ 30 IU/mL) at baseline OR low C3 and/or C4 complement relative     to the normal range at baseline.   "
104772|NCT01914757|"     The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate     in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA     with or without oral corticosteroids and additional asthma controllers.   "
104773|NCT01914744|"     The aim of this study is to prove the superiority of entecavir over lamivudine for preventing     the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on     CHOP/R-CHOP.   "
104789|NCT01914536|"     This project is an observational prospective study in which patients affected by an adult     onset Pompe disease will be followed-up during three years using different clinical,     analytical and radiological tests in order to know which is the natural history of the     disease and which is the impact that treatment with recombinant enzyme has in the progression     of the disease.   "
106173|NCT01896310|"     The aim of the present study was to propose a new pCLE classification of gastric pit patterns     and vessel architecture, and to assess the accuracy and interobserver agreement of this new     pCLE classification system in the stomach.   "
104774|NCT01914731|"     Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a stool     transplant from a healthy individual to a C. difficile-infected recipient, and has long been     a successful approach to recurrent/refractory C. difficile. The purpose of this project is to     generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used     repeatedly, particularly in those who do not have a healthy intimate partner or other related     donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by     the nasogastric route. This study will evaluate the safety and secondarily the efficacy of an     inoculum administered by frozen orally-administered capsules.      Subjects with recurrent/relapsing C. difficile infection will receive FMT via oral capsules      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,     systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.     difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a     normal bowel status for the individual. Secondary efficacy endpoints include weight,     subjective well-being and relative clinical improvement per standardized questionnaire, and     subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects     will be monitored for clinical safety by history and standard exams and the follow-up     questionnaire as well as followed closely by phone and in person.   "
104775|NCT01914718|"     The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in     patients with MYC positive diffuse large B-cell lymphoma.   "
106912|NCT01886664|"     The investigators tried to evaluate the effect of desflurane on the incidence of     postreperfusion syndrome during living donor liver transplantation surgery. The investigators     used sevoflurane as a comparison.   "
104778|NCT01914679|"     The purpose of this study is to evaluate the mechanisms of noninvasive cortical     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical     Electrostimulation RINCE)in the management of fibromyalgia. Patients who meet the 1990     American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE     treatments delivered by a medical device called NeuroPoint. Approximately 20 patients will     receive a combination of active and inactive (sham) therapy treatments over a 16-week period     followed by a 4 week post-treatment evaluation. Patients will also undergo three (3)     functional brain imaging scans while participating in the study: the first prior to the     commencement of treatment, another mid-treatment; and the third at the completion of the     treatment period.      The study's primary outcome measure will be the change from baseline in self-reported 24-hour     average pain intensity. The study's hypothesis is that there will be a change in pain     intensity as well brain functioning. We do not expect there to be a statistically significant     improvement in pain intensity due to the small sample but do expect to see statistically     significant changes in cortical function as measured by EEG and fMRI   "
104779|NCT01914666|"     The purpose of the study is to assess the long term safety of duloxetine in participants with     Chronic Low Back Pain (CLBP).   "
104780|NCT01914653|"     Prospective, single center, postmarket clinical study to obtain clinical experience with the     use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.   "
104781|NCT01914640|"     The waist circumference (WC) cut off levels of the Caucasian people may not represent the     characteristics of different ethnic groups. The investigators aimed to determine sex specific     WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in     Turkish adults.   "
104782|NCT01914627|"     The study will be conducted to evaluate the efficacy and safety of a topical dimeticone     formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15%     Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis     (scalp psoriasis).   "
104783|NCT01914614|"     The purpose of this research is to better understand the relationship between employment and     breast cancer. Research is being conducted to understand how workplace factors influence     breast cancer patients' ability to adhere to recommended cancer treatment and effectively     recover from cancer. Investigators hope to use the findings from the study to help working     breast cancer survivors make informed decisions about treatment and employment in     collaboration with their employers and healthcare providers.   "
104784|NCT01914601|"     Extensive cervical spines movement during endotracheal intubation can result in serious     neurological injury, especially in the patients with unrecognized cervical spines     injury.[1-2] Moreover, direct laryngoscopy may be difficult if spine movement is limited     because of arthritis, disc disease or a small gap between the occiput and the spinous process     of the atlas.[3-4]      Video laryngoscopes allow for intubation without alignment of the oral, pharyngeal, and     tracheal axes which minimize the cervical movements, especially in the patients with     restricted cervical movements. [5,6] Compared with the Macintosh laryngoscope, the use of     AirWay Scope decreases median upper cervical-spine movement during intubation under in-line     stabilization in patients with normal cervical-spine. [6] Unfortunately, the use video     laryngoscopes are associated with longer times to tracheal intubation compared with the     traditional techniques which may be attributed to the variable learning curves of the     practitioners. [7-9]      The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical,     Indianapolis, Indiana, USA) is an anatomically shaped, rigid laryngoscope that uses     fiberoptic technology to view the larynx with micro camera offers a 160 degree of view     potentially eliminating the need for neck flexion and head extension. [10]      To the best of the authors' knowledge, there is no study has evaluated the King vision     laryngoscope regarding the neck movement during routine tracheal intubation under general     anesthesia.   "
104785|NCT01914588|"     Heart failure is a chronic disease associated with an increasing risk of morbidity,     disability, repeated hospitalizations and mortality. Telemedicine could promptly identify     signs of worsening cardiac disease in order to improve elderly patients' home care and     quality of life by reducing the need of hospital admissions and sanitary costs. The     investigators present a randomized, parallel-group trial to test the ability of a     multiparametric remote monitoring system, in addition to standard care, to promptly identify     worsening of heart failure and prevent hospital admission and mortality.   "
104786|NCT01914575|"     Use of dipole density mapping to identify activation in complex supraventricular tachycardias   "
107033|NCT01885091|"     The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin     0.1%) in Thai patients, on the basis of the severity and clinical signs of facial     photodamage.   "
104879|NCT01913340|"     Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a     baby's brain near the time of birth, may cause death or neurologic disability. Cooling     therapy (hypothermia) provides some protection, but about half of affected infants still have     a poor outcome. This clinical trial will determine if the drug erythropoietin, given with     hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic     deficits after HIE.   "
104880|NCT01913327|"     The purpose of the study is to determine whether two commonly-prescribed antipsychotic     medications (aripiprazole and risperidone) have different effects on brain function and     cognition in schizophrenia patients.   "
104790|NCT01914523|"     Failure to successfully intubate the trachea and secure the airway remains a leading cause of     morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the     concept of endotracheal intubation was developed, 100 years ago the procedure was performed     blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization     of the larynx with a viewing angle of 15 degrees [5]. Insufficient laryngoscopic view     constitutes the main reason for difficult intubations [6].      Video laryngoscopes provide an improved view of the glottis, as the camera is a few     millimeters away from the glottis. The use of Glidescope [7-8] and AirTraq [9] laryngoscopes     has superior glottis view and ease of tracheal intubation compared with the traditional     Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer     time to tracheal intubation compared with the traditional techniques which be explained with     the variable learning curves of the practitioners. [10]      The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical,     Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices that     claim to provide the perfect view for intubation via use of video and digital technology.      The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that     attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and     house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED     light source.      Up to best of the authors' knowledge, there is no current published or ongoing randomized     controlled comparative study of the use of King Vision laryngoscope with traditional     laryngoscope and other video laryngoscopes for endotracheal intubation.   "
104791|NCT01914510|"     This is a phase 2 study to see how useful, safe, and tolerable an investigational drug called     ENMD-2076 is in treating patients with ovarian clear cell carcinomas.      ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and tyrosine     kinase from working. These enzymes are needed for cells to divide including cancer cells.     ENMD-2076 also works by stopping the growth of new blood vessels which would provide the     tumor with nutrients for it to grow. It is believed that by blocking Aurora A and tyrosine     kinase enzymes from working and stopping new blood vessels from growing, the tumors may stop     growing or shrink.   "
104792|NCT01914484|"     This is the study to test combination regimen of Nilotinib and Ruxolitinib therapy for the     treatment of patients with Philadelphia positive chronic myeloid leukemia (CML) or acute     lymphoblastic leukemia (ALL) who is resistant to multiple tyrosine kinase inhibitor therapies     with BCR-ABL kinase inhibition activity. Ruxolitinib is a tyrosine kinase inhibitor blocking     alternative pathway independent of BCR-ABL mediated pathway, thus having a potential to     overcome tyrosine kinase inhibitor resistance in Philadelphia positive CML or ALL patients.     Phase I study will be conducted to define a recommended phase II dose (RPTD) and phase II     study will examine the hypothesis that combinational approach will increase response rate of     resistant CML/ALL patients, thus evaluating efficacy of the combination regimen.   "
104793|NCT01914471|"     Objectives: We conducted a randomized controlled trial (RCT) of Students for Nutrition and     eXercise (SNaX), a middle-school-based obesity-prevention intervention combining school-wide     environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and     peer-led education and marketing.      Methods: We randomly selected schools from the Los Angeles Unified School District (LAUSD)     and assigned five to the intervention group and five to a wait-list control group. School     records were obtained for number of fruits and vegetables served, students served lunch, and     snacks sold per attending student. Pre- and post-intervention surveys assessed psychosocial     variables among 2,997 seventh-graders (75% of all seventh-graders across schools).      Hypotheses: For the RCT of SNaX, we hypothesized that SNaX would lead to increases in the     proportion of students served in the cafeteria (because SNaX markets cafeterias' healthy     foods); increased fruit and vegetable servings (because SNaX increases access to     sliced/bite-sized fruits and vegetables); decreased school store snack sales; and greater     water consumption. We also hypothesized that SNaX would lead to more positive attitudes about     the cafeteria and water, improve obesity-prevention knowledge, and increase intentions to     drink water.   "
104794|NCT01914458|"     Lung cancer is the leading cause of cancer related death in Taiwan and world wide. The     application of low dose helical computed tomography (CT) has been the milestone of lung     cancer screening. Recently, The National Lung Screening Trial (NLST) shows screening with     low-dose CT could reduce mortality from lung cancer. We conducted this clinical trial to     determine the efficacy of low dose CT in early lung cancer screening in Taiwan.   "
104795|NCT01914445|"     The purpose of this study is to examine whether oral administration of Indigo Carmine     together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used     instead of staining during the examination itself.   "
104796|NCT01914432|"     To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies     in patients with hypertension and hyperlipidemia   "
104797|NCT01914419|"     The study will evaluate whether prophylactic oxytocin administered in the third stage of     labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage     compared to intramuscular (IM) injection.   "
104798|NCT01914406|"     The aim of this study was to examine the effects of high intensity aerobic interval training     (AIT) versus moderate continuous training (CON) in heart transplant recipients.   "
104799|NCT01914393|"     This is an open-label, 104-week, multicenter, extension study designed to evaluate the     long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or     80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the     preceding studies, D1050301, D1050325, and D1050326   "
104800|NCT01914380|"     The study aims to investigate the effectiveness of Eylea in patients with wet age-related     macular degeneration in routine clinical practice in Germany. The study is purely     observational, only data from routine treatment are to be collected. The treatment and     treatment conditions are solely at discretion of the treating physician.   "
104834|NCT01913938|"     The purpose of the study is to find out whether non-responsiveness to therapeutic recombinant     human granulocyte colony-stimulation factor (rhG-CSF) is associated with hemophagocytosis in     critically ill adult patients with cytopenias.   "
104891|NCT01913184|"     To compare the continuous and sicontinuous delivery of drug with AKITA.   "
104892|NCT01913171|"     o determine effects of hula-hooping on android obesity, metabolic parameters and adipose     tissue (AT) gene expression.   "
104801|NCT01914367|"     Six identical female twins aged 9-13 years will participate. One sib of each twin pair will     be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will     be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood samples will     be taken (the first prior to vaccine administration, the second and third 7 days after dose 2     and 3, respectively). The blood samples will be used to determine: 1) the magnitude the     anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the cross-reactive pattern of     these responses towards related, non-vaccine HPV strains (HPV-31 and -33, and HPV-45). 3)     plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and     eventually after the 2nd dose also) will be examined for for the usage of VDJ and VJ segments     in the immunoglobulin heavy (VH) and light (VL) heavy and light chains. Gene useg in B cells     induced by Cervarix and Gardasil will be compared. Finally the cross-reactive potential of     monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light     (VL) chains from single ASC isolated after the 3rd dose of a three-dose schedule of either     Cervarix or Gardasil will be examined.      The duration of the study is approximately 187 days. Five study visits will take place, over     a time period of 6.5 months, followed by a telephone call after 12 months.      The purpose of the study is to learn more about the molecular mechanisms underlying the     cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the     aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).   "
104802|NCT01914354|"     This is an observational multi-center study to determine whether any single immune monitoring     test or a combination of tests obtained in the first 6 months after renal transplantation     correlates with acute rejection or graft loss in renal allograft recipients receiving     commonly used immunosuppressive.   "
104803|NCT01914341|"     The purpose of this study is to determine the effects of live music on physiological     parameters in newborn infants. The mother is asked about the effects of music on her own and     the child's wellbeing.   "
104804|NCT01914328|"     The purpose of this study is to determine the incidence of pulmonary complications in     patients undergone major abdominal elective surgery performed under general anesthesia.   "
104805|NCT01914315|"     The purpose of this prospective study is to determine whether comprehensive cardiac     rehabilitation is superior to usual disease management in the treatment of patients with     heart failure with preserved systolic function (HFpEF) recently discharged after an acute     heart failure event.      The investigators hypothesize that the addition of bi-weekly structured exercise training and     interaction with medical personnel will lead to a greater reduction in all cause     hospitalization and mortality while providing additional functional and clinical benefits     such as exercise capacity, quality of life and well-being.      Furthermore the investigators seek to establish clinical, laboratory and echocardiographic     predictors of hospital readmissions and cardiovascular events in the predefined HFpEF     population.   "
104806|NCT01914302|"     Characterize expressed blood volume ≥1μL across representative, commercially available     lancing device systems using finger sticks.   "
104807|NCT01914289|"     The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma     (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.   "
104808|NCT01914276|"     Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging     surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging     surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in     women with endometrial cancer who undergo staging surgery.      Data analysis and risk/safety issues: The proposed study will consist of a convenience sample     of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period.     The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference     with its 95% exact confidence intervals between pre-and post-operative lower extremity     lymphedema measurements and quality of life questionnaires will be estimated.   "
104809|NCT01914263|"     Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T     lymphocytes which present a mixed T-NK phenotype and are endowed with a major     histocompatibility complex-unrestricted antitumor activity. Radical surgery is a good therapy     for patients with solid tumor.However, tumor relapse is still a risk for those patients. Our     hypothsis is that cytokine induced killer cells maybe decrease the recurrence rate. The     purpose of this study is to evaluate the safety and tolerability of cord blood-derived     cytokine induced killer cells in patients with solid tumor following radical resection.   "
104810|NCT01914250|"     The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the     pain associated with neonatal frenotomy.   "
104811|NCT01914237|"     Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic     arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of     Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.      Number of patients: 70 patients will be included and undertaken endovascular repair with     Castor stent.      Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after     the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery      Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.      Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.      Other Outcome Measures:        1. efficacy:             -  1 year success rate of treatment             -  1 year patency rate of branch stent        2. safety:             -  in-hospital mortality             -  complication rate of neural system             -  1 year dissection or stent related mortality   "
104812|NCT01914224|"     Reduction in sodium consumption is important approach in public health care. In general     population, reduction of sodium intake can reduce the future development of hypertension and     cardiovascular event. Meanwhile, enhancement of potassium consumption is also important to     reduce blood pressure and cardiovascular events. We hypothesized that combined education of     low sodium and high potassium consumption is more effective in reducing blood pressure     compared to dietary education of low sodium consumption only.      The present survey study was designed to test the effectiveness of combined education of low     sodium and high potassium consumption in blood pressure reduction and improvement of other     variables.   "
104813|NCT01914211|"     This is an observational, prospective study to evaluate the role of tranexamic acid in     reducing blood transfusion in neonates undergoing cardiopulmonary bypass.   "
104815|NCT01914185|"     The objectives were to 1) make students eat healthier and be more active; and 2) prevent     overweight and obesity. Children will therefore be less likely overweight or obese. Beginning     in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools     (APPLE Schools) was implemented in 10 schools throughout the Canadian Province, Alberta.     Full-time School Health Facilitators were placed in each of the schools to implement what is     know in Canada as Comprehensive School Health (CSH). In the United States, CSH is more     commonly referred to as Coordinated School Health, while the synonymous term Health     Promoting Schools is often used in Australia and Europe. The project was evaluated annually     in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped     pedometers. The comparison group included approximately 150 schools that were randomly     selected to reflect the population of Alberta, Canada. Twenty of these randomly selected     schools also participated in data collection which involved the use of time-stamped     pedometers.   "
104816|NCT01914172|"     Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a     rare endocrine disorder that is characterized by failure to undergo puberty combined with     infertility. KS/CHH patients face a number of psychosocial burdens related to delays in     diagnosis, inadequate access to expert care, and lack of information about the condition. As     such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This     study aims to identify the needs of patients and understand the issues that must be overcome     to achieve improved health and quality of life.   "
104817|NCT01914159|"     The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration     (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical     trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab     (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study     period of 12 months in 30 patients.   "
104818|NCT01914146|"     In the proposed study, the investigators examine in older adults with Type 2 diabetes the     impact of beginning insulin therapy on the orthostatic drop in blood pressure as well as the     response of arterial blood pressure and Doppler measures of cerebral blood flow during     upright tilt. The investigators hypothesize that in older adults with Type 2 diabetes, the     cardiovascular effects of insulin would precipitate or worsen orthostatic intolerance not     present at baseline.   "
104819|NCT01914133|"     The current proposal will determine if blocking carbohydrate intake in the small intestine     with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial Hypotension     (a drop of blood pressure after eating), which can result in falls.   "
104820|NCT01914120|"     The goal of this study is assess the quality of life of advanced non-small cell lung cancer     (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and     tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer     Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st     cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the     subscales and constructs of FACT-L. The assumption is the quality of life will be better     after 2 cycle of chemotherapy.   "
104821|NCT01914107|"     This study aim at the advanced malignant tumor patients who suffer from cancer pain,     investigate the current status of cancer pain treatment, and study the effects in pain     control and quality of life improvement using the method of real-time monitoring and     treatment instruction of cancer pain. This study is a randomized, controlled, single center     clinical study. After recruitment, the subjects will randomly assign to standard cancer pain     treatment group and standard cancer pain treatment plus real-time dynamic monitoring and     treatment intervention of cancer pain using the cloud computing concept system. And then,     assess the alleviation of cancer pain and quality of live. The assumption is the system will     alleviate the cancer pain efficiently.   "
104822|NCT01914094|"     Low levels of physical fitness increase the risk of death in patients with cardiovascular     disease. Although cardiac rehabilitation programs improve the health of patients after heart     surgery, most patients are not referred until after surgery. Therefore, the purpose of this     study was to determine if an exercise pre-habilitation (i.e., Prehab) program before heart     surgery would improve the health of patients before surgery and whether these improvements     would be maintained after surgery.      The investigators hypothesized that Prehab would promote the health of patients before heart     surgery, and these improvements would be maintained three months post-operatively, as     compared to patients who received standard care.   "
104823|NCT01914081|"     The purpose of this study is to determine if resveratrol can improve heart function and     quality of life. Although, population studies have revealed that a mild to moderate intake of     red wine reduces cardiovascular disease risk in humans, clinical studies that evaluate the     potential heart benefits of resveratrol in patients with non-ischemic cardiomyopathy have not     been previously reported. Accordingly, this research is being done because it will fill this     deficiency in the information available in the literature and establish the clinical benefits     of resveratrol in patients with this type of heart disease.   "
104859|NCT01913600|"     Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety     and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native     coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients who     receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.   "
104860|NCT01913587|"     This study is to investigate the effectiveness of acupuncture for alleviating pain from     Spinal Compression Fracture in Patients Treated with Nerve Block.   "
104835|NCT01913925|"     The objective of this research is to determine if tyrosine, an amino acid found in     protein-containing foods, will mitigate the cognitive deficits and adverse effects on     behavior and mood produced by exposure to military stress. This study was conducted at the US     Navy Survive, Evade, Resist, Escape (SERE) school at Brunswick, Maine (ME).      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain     neurotransmitter that is critical for the central nervous system (CNS) response to various     types of acute stress. Psychological stress increases catecholamine turnover in the brain,     increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and     human studies have shown that tyrosine supplementation can produce beneficial effects on     cognitive and physiological functions during exposure to a variety of acute stressors.      This project will determine if volunteers treated with supplemental tyrosine during stressful     phases of SERE training experience less degradation in cognitive performance and mood than     volunteers treated with placebo. Tyrosine or placebo will be administered in a specially     developed food bar provided to volunteers. The bar is part of a prototype of ration-component     designed for use during assault operations. A between-subjects, double blind experimental     design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has     been tested in hundreds of volunteers without adverse effects.      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 80     volunteers complete the study. They will be tested during several portions of SERE. A     comprehensive but brief battery of cognitive tests, as well as saliva samples, and heart rate     data will be collected in a manner that does not interfere with ongoing training.      Hypotheses:        1. Exposure to the stressors of SERE school will adversely impact cognitive performance and          mood of volunteers.        2. The adverse effects of psychological stress on cognitive performance and mood during          SERE school will be reduced when volunteers are given supplemental tyrosine compared to          placebo treatment.   "
139732|NCT01455675|"     The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa     after successfully treated acute or intermittent infection.   "
104824|NCT01914068|"     Patients' ability to tolerate surgery is associated with physical fitness: less fit patients     have an increased rate of death and serious complications following major surgery. Combined     chemotherapy and radiotherapy (x-rays) prior to rectal cancer surgery is known as     neo-adjuvant chemoradiotherapy (NACRT) and is associated with improved cancer removal but     adversely affects physical fitness. In Liverpool, the investigators have pre-pilot data     showing that NACRT reduces objectively measured physical fitness (measured by cardiopulmonary     exercise testing) in patients having surgery. This pre-pilot study investigated the effects     of a 6-week structured responsive endurance training programme (SRETP) after NACRT and before     cancer surgery. This programme has improved both their fitness and their health related     quality of life(HRQL). Now, the investigators are undertaking a randomised controlled trial     to compare changes in patient's physical fitness in response to SRETP with a group of     patients who will be given exercise advice. The SRETP group will exercise 3 times a week for     9 weeks. The investigators will make objective measurements of physical fitness in both     groups. The investigators will monitor patient's perceptions of the training programme, HRQL,     daily activity (using an accelerometer), and outcomes after surgery. The investigators     believe that, patients in the exercise group will improve their physical fitness prior to     surgery, change behaviour towards exercise, improve activity and HRQL following NACRT. These     results will contribute to the design of a large, multi-centre trial to determine whether a     SRETP increases physical fitness with a reduction in adverse outcome following surgery. The     investigators will conduct an adequately powered randomized controlled trial (RCT) comparing     a SRETP with 'exercise advice' in 46 rectal cancer patients. Specifically, we will test the     following hypotheses and outcomes: PRIMARY HYPOTHESIS A 9-week, structured responsive     endurance training programme (SRETP) compared with a control group (no training) will result     in a clinically significant difference in physical fitness (2.0ml/kg/min VO2 at LT)     post-NACRT prior to surgery.      SECONDARY OUTCOMES        1. A 9-week SRETP compared with a control group (no training) will result in a clinically          significant difference in physical fitness (2.0ml/kg/min VO2Peak) in patients who have          had NACRT prior to surgery.        2. SRETP following NACRT and prior to cancer surgery will provide psychological health          benefits and improve patient's HRQL (assessed by semi-structured interviews and          questionnaires -EORTC QLQ-30 and EQ-5D). This will provide vital exploratory information          that will inform a future application to deliver a larger appropriately powered RCT          exploring the hypothesis that patients with greater pre-operative fitness will encounter          lower postoperative morbidity and mortality. Specifically, these exploratory outcomes          are:      EXPLORATORY OUTCOMES        1. To investigate whether SRETP following NACRT and prior to surgery is associated with a          change in overall physical activity (assessed by the number of steps while active using          an accelerometer).        2. To investigate whether there is a change in the day 7 surgical morbidity (using the          Post-Operative Morbidity Survey) and mortality.        3. The effect of SRETP on cancer downstaging post-NACRT (Tumour, Node and Metastasis          Staging-TNM staging).   "
104825|NCT01914055|"     demonstrate that FD-OCT guidance is feasible and possibly results in reduction of     frequency-domain Optical Coherence Tomography-defined residual thrombus burden after     thrombus-aspiration.   "
104826|NCT01914042|"     Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid     treatment in patients with chronic neuropathic pain.   "
104827|NCT01914029|"     The purpose of the study is to add to the knowledge of mechanisms of immune health.     Parameters of the immune system will be followed over time in volunteers allergic to dust     mites and bee sting after receiving immunization therapy. This information will be compared     to healthy volunteers without allergy. We aim to bring new understanding of immune processes     by this comparison.   "
104828|NCT01914016|"     People with Multiple Sclerosis (pwMS) often experience 'foot-drop' which means that the foot     is not adequately lifted during the so-called swing phase (foot is off the ground) during     walking which can lead to trips and falls. Functional Electrical Stimulation (FES) to the     shin muscles will aid lifting of the foot and therefore reduces the risk of trips and falls.     There have been several studies showing the benefits of FES to the walking of pwMS. The     proposed study aims to optimise the FES prescription and fitting care pathway for pwMS in     Edinburgh and the Lothians This will be achieved firstly through a survey to all clients with     MS in the last 5 years who have been regarded as suitable for FES. Secondly, a pilot study     will assess the suitability of the use of simple clinical measurement (electrogoniometry)     which will allow the measurement of the degree of foot-drop. The degree is foot drop is     usually assessed by the physiotherapist using visual observation. Using a small device which     can be quickly fitted to the patient's lower and foot for the duration of a 2-6 minute walk,     the physiotherapist will be able to quantify the degree of foot drop over time. Such a     measurement is especially important for people with MS who are often affected by increased     mental and physical fatigue.      Our first hypothesis is that the degree of foot-drop at the end of the walk is increased     compared to the start of the walk. Secondly, we hypothesise that the degree of foot drop is     less when the participant walks with the assistance of Functional Electrical Stimulation at     their next clinical appointment.   "
104829|NCT01914003|"     Congenital sucrose-isomaltase deficiency (CSID) is a rare, genetic disease in which mutations     in the sucrose-isomaltase (SI) gene cause digestion problems of sucrose resulting in diarrhea     and abdominal pain. Children with chronic, idiopathic diarrhea or abdominal pain will have     their sucrose-isomaltase gene assessed for a panel of known CSID mutations to determine the     prevalence of these mutations in an enriched population and also determine functional     deficiency using a breath test.   "
104830|NCT01913990|"     For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis     (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting)     control compared with standard anti-emetic regimen. The risk calculator has the potential     to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly     anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate     anti-emetic regimen in patients at high risk.   "
104861|NCT01913574|"     This study is to investigate the effectiveness of acupuncture for alleviating the upper     abdominal pain of cancer patients   "
106220|NCT01895686|"     The aim of this study is to analyze similarities and evaluate interchangeability of Visante     and Cirrus OCT (optical coherent tomography)and to compare agreement between gonioscopy and     the two systems for evaluation of anterior segment parameters.   "
104831|NCT01913977|"     This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome)     treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2     (carbon dioxide)removal might be necessary. We hereby work with the Abylcap system with the     oxygenator Lilliput2 as CO2 remover (Bellco, Italy).      The patients (M/V) are older than 18, not pregnant, have a BMI<30, and no contraindication     for anticoagulation therapy.      Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas     flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the     patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h.      A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL)     are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time     points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG)     1.5, 3, 6, 7, 8L/min      Blood samples are analysed for the different blood gases from which the extraction in the CO2     remover can be calculated for each setting of QB (blood flow) and QG (gas flow).   "
104832|NCT01913964|"     To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily     activity, and fatigue in subjects with chronic hepatitis C treated with     Pegylated-Interferon-α2b and Ribavirin.   "
104833|NCT01913951|"     This phase I trial studies the side effects and the best dose of vosaroxin when given     together with azacitidine in treating patients with myelodysplastic syndromes. Drugs used in     chemotherapy, such as vosaroxin and azacitidine, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing.   "
131024|NCT01570010|"     The aim of this study to examine whether an intensive dietary intervention affects health     measures and development of lifestyle diseases in colorectal cancer survivors.   "
104836|NCT01913912|"     Stimulants alleviate information processing and task performance deficits in Attention     Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as     lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and     improve classroom performance. Although stimulants have been widely used in treatment of     ADHD, the exact mechanism action and effect on task performance is not completely known.      According to the State Regulation Deficit (SRD) model, children with ADHD have difficulty     regulating their levels of arousal/activation during tasks in response to the changing     demands of the environment. This leads to problems with downregulating overaroused states and     upregulating underaroused states. According to this view, stimulants exert their therapeutic     effect (in part) by optimising arousal/activation levels - especially during states of     underarousal/activation. Arousal/activation levels can also be altered by extrinsic factors     such as event rate (ER), e.g., the rate at which information is presented. Multiple studies     suggest that very fast and very slow events can both cause problems for individuals with     ADHD, related to overarousal and underarousal state respectively. Putting these intrinsic     (stimulants) and extrinsic (ERs) factors together leads to the prediction that changing the     rate at which information is presented in a task may alter the efficacy of stimulants and     affect the optimal stimulant dose level. More specifically, one dose of stimulant that may be     optimal on slow ER tasks (as it increases arousal/activation level) may be less effective     under high ER tasks because in such a setting arousal/activation level needs to be lowered     and not increased further. Adding stimulants to an already overactivated state may exacerbate     the associated problems. The implication of this is that a different dose of stimulant will     be needed under different environmental conditions for optimal performance. For example,     children with ADHD might require different dosage in the classroom setting to optimize     performance. In addition, the neuropsychological basis of performance deficits and     improvement by ER and stimulants are also unclear. According to the SRD model, the underlying     mechanism can be specific problems in motor activation/preparation or effort regulation.     Event-related potentials (ERP), pupil size measurements and cardiac measures enable us to see     objectively how motor activation/preparation and effort are affected by ER and simulants.      In this study the investigators aim to test these predictions of the SRD model and identify     the neurobiological basis of stimulant action.   "
104837|NCT01913899|"     The aim of the study is the measurement of the short term effect of post surgical mirror     therapy concerning pain intensity and frequency of patients with upper or lower amputation in     comparison to standard occupational or physical therapy. The hypothesis is that patients in     the intervention group (mirror therapy) suffer significantly less from phantom limb pain and     pain attacks within a follow-up period of 4-8 weeks.   "
104838|NCT01913886|"     This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal     stem cells (MSCs) to repair heart function in patients with myocardial ischemia.   "
104839|NCT01913873|"     Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is     expected. The level of injury can be shown by measuring the blood levels of specific     molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute     cardiac care to diagnose a myocardial infarction.      Postoperative heart infarction remains a frequent and important complication after heart     surgery.Therefore it is important to recognize any cardiac event in patients who underwent     heart surgery. Although different diagnostic tools can be used to recognize these events, few     is known about the value of those cardiac biomarkers to diagnose a myocardial infarction     after heart surgery.      In this study the investigators will describe the concentration changes of those cardiac     biomarkers over time in patients undergoing heart surgery, and the investigators will try to     establish a upper level value who could indicate heart infarction.   "
104840|NCT01913860|"     Background The over use of antimicrobials is recognised as the main selective pressure     driving the emergence and spread of antimicrobial resistance in human bacterial pathogens.     Urinary Tract Infections (UTIs) are one of the most common infections presented in primary     care and empirical antimicrobial treatment is currently recommended. Previous research has     identified that a substantial proportion of Irish GPs prescribe antimicrobials for UTI that     are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in     Ireland.      Aim To design, implement and evaluate the effectiveness of a complex intervention on GP     antimicrobial prescribing and adult (18 years of age and over) patients' antimicrobial     consumption when presenting with a suspected UTI.      Methods The SIMPLE study is a randomised three armed intervention with practice level     randomisation. Adult patients presenting with suspected UTI in primary care will be included     in the study.      The intervention integrates components for both GPs and patients. For GPs the intervention     includes interactive workshops, audit and feedback reports and automated electronic prompts     summarising recommended first line antimicrobial treatment and, for one intervention arm, a     recommendation to consider delayed antimicrobial prescribing. For patients multimedia     applications and information leaflets are included. A minimum of 920 patients will be     recruited through 30 practices. The primary outcome is change in prescribing of first line     antimicrobials in accordance with the Guidelines for Antimicrobial Prescribing in Primary     Care in Ireland. The intervention will take place over 15 months. Data will be collected     through a remote electronic anonymised data extraction system (iPCRN), a text messaging     system and through GP and patient interviews and surveys. The intervention will be     strengthened by the implementation of a social marketing framework and an economic     evaluation.   "
104841|NCT01913847|"     The purpose of this study is to investigate the safety and clinical efficacy of HGP1207     (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.   "
104912|NCT01912911|"     The investigators goal in this study is to examine the feasibility and efficacy of AliveCor     iphone case monitoring device in monitoring patients after AF ablation by comparing     transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor     (TTM).      A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM     system from the patient's perspective   "
106262|NCT01895140|"     The purpose of this study is to evaluate the clinical and economic impact of implementation     of renal denervation with the Symplicity™ Catheter System for treatment-resistant     hypertension in Ontario, Canada.   "
104842|NCT01913834|"     Osteoporosis is a reduction in bone density that increases the risk of fractures;     particularly of the spine, hip and wrist. Osteoporosis is estimated to affect 200 million     women worldwide - approximately one tenth of women aged 60, one-fifth of women aged 70,     two-fifths of women aged 80 and two-thirds of women aged 90. Treating osteoporosis and the     associated fractures costs the NHS more than two billion pounds per annum.      Teriparatide is a drug currently prescribed for some osteoporosis patients by their doctor to     be taken by injection. It is currently the only drug available which promotes the deposition     of new bone as opposed to preventing resorption. This is the drug treatment we will be     studying in this clinical trial.      The drug is of a type that cannot normally be taken as a swallowed pill. This type of drugs     tends to be delivered by injection, as is currently the case for teriparatide. Injections     have numerous limitations and are disliked by patients.      This trial will assess how well the nasal spray devices work, how long the drug stays in the     nose and also how well the drug enters the bloodstream.   "
104843|NCT01913808|"     Postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main     consequence of perioperative anaemia is an increased risk of red blood cell (RBC)     transfusions. Allogeneic RBC transfusion and anaemia are associated with higher postoperative     mortality and morbidity.      The aim of this study was to compare the efficacy of postoperative i.v. ferric carboxymaltose     (FCM) and oral ferrous glycine sulphate (FS) for early improvement of postoperative anaemia     after total knee arthroplasty and whether iron treatment could facilitate recovery from     surgery.   "
104844|NCT01913795|"     The investigators aim to pilot the role of school based intervention consisting of enhanced     integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.   "
104863|NCT01913548|"     The purpose of this study is to demonstrate that a sufficient number of iron-overloaded     thalassemia (THAL), Sickle Cell Disease (SCD)and Diamond Blackfan Anemia (DBA) populations     with similar duration of chronic transfusion, and age at start of transfusions would be     available for a confirmatory study. The study will examine the hypothesis that a chronic     inflammatory state in SCD leads to hepcidin- and cytokine-mediated iron withholding within     the RES (reticuloendothelial system), lower plasma NTBI (non-transferrin bound iron) levels,     less distribution of iron to the heart in SCD.   "
104845|NCT01913782|"     Chronic low back pain (CLBP) is the most prevalent form of chronic pain, and the most common     reason for disability in working-age population [2]. CLBP has also been reported associated     with many abnormal brain anatomy and function which includes the reduction in cortical gray     matter in the bilateral dorsolateral prefrontal cortex (DLPFC), thalamus, brain stem, primary     somatosensory cortex, and posterior parietal cortex. [3-5] There are already many studies     that demonstrated abnormal cortical function for people with CLBP [6-10]. Meanwhile, DLPFC     was also reported to be influenced by many pain process which included pain modulation     [11-13], placebo analgesia [14, 15], pain control [16, 17]or pain catastrophizing[18]. And     recent report has showed that effective treatment of chronic back pain patients reverses     abnormal DLPFC function[19]. Meanwhile, epidural steroid injection has been performed in     clinical for routinely managed for low back pain patients. Patients refused or have no     indication for surgery or have little response to rehabilitation may consider this     management. There was good evidence for short- and long-term relief of chronic pain secondary     to disc herniation with local anesthetic and steroids[20, 21]. However, the impact of this     treatment on functionalMRI (fMRI) has never been investigated. The investigators research     will try to solve this issue.      This study will provide a good relationship for the pain fMRI image in brain after local     lumbar spine management. And the investigators also want to perform the first data that     showed local lumbar analgesia have the impact on brain image change.   "
104846|NCT01913769|"     Background:      Chemoradiation is an important treatment strategy of locally advanced inoperable or     unresectable disease. Radiation dose is an independent predictor of a pathological response.     In addition, chemotherapy has further impact on the aspect of outcome. Improvements in local     treatment delivery are needed to facilitate dose escalation and to minimize toxicity. There     have been sequential improvements in tumor localization, radiation planning and delivery over     the years. Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT)     dose delivered to thoracic malignancies, and allows greater sparing of the heart from doses     associated with increased complications. However, heart disease shows a wide spectrum of     pathologies, and multiple risk factors related. The damage of the myocytes may lead to not     only myocardial perfusion defects, but also in functional deterioration, or even in     biomarkers.      Since the impact of radiation-induced heart injury in patients with thoracic malignancies     (including esophageal cancer, lung cancer, et al) is poorly documented, we try to delineate     of RT-related cardiac effects and clinical impacts.      Objective:      This study aims to investigate the correlation of post-tomotherapy cardiovascular effects     with myocardial perfusion and cardiac functional studies.      Methods:      The study plans to enroll thoracic cancer patients who will undergo local RT after complete     staging. Patients will receive global risk scoring assessment (Framingham Risk Score, FRS),     blood sampling for basic biochemistry, inflammatory biomarker, and myocardial perfusion image     (MPI) at the time points of before and after RT. The results of MPI will be analyzed in     qualitative visual interpretation of perfusion patterns, and functional quantitative data for     cardiac functional parameters as well. The patients will be regular followed-up in CV OPD,     following clinical judgement and guideline. The association between baseline and follow-up     MPI, biomarker and clinical presentation will be further investigated.      Expected results:      We will obtain myocardial perfusion visual qualitative data in patients who received     locoregional RT, respectively. These results will help in the understanding of     pathophysiology, clinical management and follow-up of suspected RT-related heart disease.   "
104847|NCT01913756|"     The purpose of this trial is to investigate the effect of dairy products on the so called     metabolic syndrome. Metabolic syndrome is a cluster of risk factors, such as high blood     pressure and high cholesterol, for the development of diabetes and heart disease.     Participants will be randomly assigned to either eat a portion of a Norwegian traditional     cheese which is high in protein and low in fat (group 1), or eat a slightly higher than     normal intake of regular Gouda-type cheese (group 2), or to limit their intake of cheese     (group 3).      Dairy products are a significant source of bioactive peptides, small pieces of protein which     may have an effect on our health. These effects may be antimicrobial, antioxidative, or blood     pressure lowering. The traditional Norwegian cheese, Gamalost, which is naturally high in     protein (50%) and low in fat (<1%), has been found to be particularly high in these bioactive     peptides. Specifically, the cheese was found to have a very high ACE-inhibitory activity,     meaning it has the potential to lower blood pressure without the use of pharmaceuticals.      A pilot study was performed in May 2012. No intervention was given in this trial, but     participants answered an extensive questionnaire about dietary habits and lifestyle. This     trial found that the people who ate the most Gamalost had a slightly lower blood pressure     than those that did not eat the cheese. Since that was just a point-in-time study with no     intervention or control, the investigators are not able to say anything certain about cause     and effect, which is why the investigators want to perform this larger controlled study.      In total, the investigators aim to recruit 300 people to participate in this trial, i.e. 100     in each group. The participants will be randomly placed in one of the groups and they will     have to do the intervention for eight weeks. At inclusion, the investigators measure blood     pressure, fasting blood glucose, weight, height, waist circumference, and the investigators     draw a fasting blood sample to measure cholesterol. The same measurements will be repeated at     the end of the eight weeks. At inclusion they will also fill out an extensive questionnaire     about their diet and lifestyle. A shorter version of the same questionnaire will also be     given at the end of the trial period.      The overall goal of the study is to assess the effect of dairy products on the metabolic     syndrome, but the main hypothesis is to assess whether a high intake of Gamalost can reduce     blood pressure in a group of people.   "
104848|NCT01913743|"     Previous studies have shown that obese individuals exhibit greater reward-related brain     activity in response to food cues than lean individuals and our group has shown that     successful weight loss maintainers who were previously obese and now maintain a healthy     weight have increased control-related activity when viewing food cues. These findings suggest     key roles for both reward-related brain areas and inhibitory control regions in eating     behavior. However, no studies to date have examined (a) whether the response to food cues     (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are most     effective at altering brain response to food cues, or (c) the neural mechanisms that support     such change.      Given the omnipresent environmental cues to eat and the association between heightened     reward-responsivity and obesity, it is critical to investigate ways to potentially alter food     cue-reactivity in the obese. The most widely employed approach for behavioral weight loss     treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to control and     change cognitions (e.g., avoid desire to eat tempting foods by focusing on something else).     This approach is sometimes described as change- focused because modifying negative thoughts     is assumed to thereby change associated maladaptive emotions and behaviors. Alternatively,     emerging evidence suggests Acceptance and Commitment Therapy (ACT), which teaches     participants to recognize and accept their cravings as feelings that need not be acted upon,     may also be effective in treating obesity. A third strategy often employed in smoking     cessation and substance abuse treatment is to focus on the long-term consequences of     behaviors, however this form of treatment is not typically used in behavioral weight loss     therapy. Thus although each approach is potentially effective, these treatment approaches     differ greatly in the cognitive strategies they employ.      The primary aim of the proposed research is to compare a cognitive strategy used in CBT     (ʻCHANGEʼ), a cognitive strategy emphasized in ACT (ʻACCEPTʼ), and a cognitive strategy used     in smoking cessation (ʻLATERʼ) relative to a control condition (ʻNOWʼ), in their     effectiveness in altering reward and inhibitory control responses to food cues among obese     individuals.   "
104849|NCT01913730|"     This is a multicenter, randomized, open label study designed to evaluate the efficacy and     safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage     treatment containing bortezomib for relapsed or refractory multiple myeloma patients.   "
104850|NCT01913717|"     The present research project aims to improve the current treatment for prostate-confined     tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy     schedule administered with one of the best available dose delivery systems. The study will     include 2 sub-studies (in-silica and clinical study) and 4 tasks.   "
104851|NCT01913704|"     The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen     device versus a placebo in patients with non-healing leg ulceration in conjunction with     standard best practice.   "
104864|NCT01913535|"     This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of     oral CERC-501 for treating patients with treatment resistant depression who are taking an     antidepressant that is not working for them.   "
104852|NCT01913691|"     Background:      - Ipilimumab is a drug used to treat melanoma that cannot be treated surgically. It targets a     molecule found on T-cells in the human immune system. Blocking these molecules on the T-cells     might allow the cells to help destroy melanoma cells more effectively. This drug has also     been studied in other cancers such as prostate cancer and lung cancer, but not yet in Merkel     cell carcinoma (MCC). Researchers think therapy like ipilimumab that enhances the immune     system may be effective against MCC. They want to study how safe the drug is and its effect     on the immune system and tumors.      Objectives:      - To determine the number of subjects with MCC who take the study drug that remain alive 12     months later.      Eligibility:      - Adults 18 years and older who have metastatic MCC.      Design:        -  Participants will be screened with a medical history and physical exam.        -  Participants will receive the study drug 4 times, one dose every 21 days. After the 4          visits, participants will receive a maintenance dose of the drug every 12 weeks until          the drug is no longer beneficial.        -  They will receive the drug through a plastic tube usually inserted in a vein on the arm.        -  It will take 90 minutes to give each dose.        -  At all visits, participants will be screened with a medical history, physical exam, and          blood tests. Any tumors on their skin will be measured and photographed.        -  Every 12 weeks during the study and maintenance period, participants will have a CT          scan. Throughout the study and maintenance period, they will have blood and skin tests.   "
104853|NCT01913678|"     The objective of this study is to investigate whether intake of a diet with a high content of     butyrate (from dairy fat) can affect blood FIAF concentration compared to a control diet.     Further to examine whether high intake of inulin (a prebiotic) can increase the proportion of     butyrate-producing bacteria in the gut and thereby affect blood FIAF concentration. In     addition, the correlation between FIAF blood concentrations and resting energy expenditure,     blood lipid profile and gut microbiota composition will be investigated.      Furthermore, this study will investigate whether the source of FIAF can be determined. To     this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal     water samples will be carried out.      The study is a crossover randomized controlled trials with 3 arms. Each arm has a duration of     3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to the     order of interventions. Before and after each intervention period, blood samples will be     collected and the participants will have their resting metabolic rate measured. At the end of     each intervention period, the participants will collect feces for 5 consecutive days. In     addition, adipose tissue biopsies will be taken after each intervention period.   "
104854|NCT01913665|"     The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on     functional constipation in children   "
104855|NCT01913652|"     Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50     histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct     genetic, pathological and clinical profiles, and varying patterns of tumor spread. The     optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which     are most effective include doxorubicin and ifosfamide, but objective response rates and     progression-free survival times remain modest. There is clearly a need to improve treatment     options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin     in cells, interfering with cancer cell division and growth , has demonstrated activity in     STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like     cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective     and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of     this trial is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate     sufficient antitumor activity for liposarcoma.   "
104856|NCT01913639|"     The purpose of this study is to evaluate the effects, good and/or bad, of the drug     regorafenib with chemotherapy regime (FOLFOX). This is a a Phase II trial that will study if     this new treatment is effective and safe in patients with esophagus and stomach cancer.   "
104862|NCT01913561|"     The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable     12/15-lead ECG.      The electrodes are dry, textile ECG electrodes. The garment is designed to position the     electrodes in the appropriate anatomical locations, without any special guidance. The dry     electrodes are made from unique yarns with silver embedded into the garment using a     proprietary technique developed by HealthWatch (HW)that obviates the need for skin     preparation or the application of fluids. The garment can be connected to any standard ECG     device available in the hospitals.      The purpose of this study is to evaluate the safety and effectiveness of the Master Caution     Garment for continuous monitoring of ECG signal compared to standard gel electrodes.      The following endpoints will be evaluated in subjects participating in the study:      Primary:      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes     using standard ECG devices.      Secondary:      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes     when event is detected by the ECG devices.   "
104865|NCT01913522|"     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated     with reductions in quality of life, functional status, cardiac performance, and overall     survival.1 Catheter ablation, which is centered on electrical isolation of triggering foci     within the pulmonary veins (PVI) through circumferential lesions around PV ostia, has been     shown to result in sustained improvements in quality of life, decreased hospitalizations and,     potentially, improved survival.2-4 PVI can be accomplished by percutaneous catheter-based     thermo-coagulation (burning) with radiofrequency (RF) energy delivery or alternatively by     thermo-cooling (freezing) with a cryoballoon catheter.5 Cryothermal ablation with a     cryoballoon catheter offers an efficacious means to achieve PVI that is safer than the     established technique. Although cryoballoon ablation has been used in clinical practice for     sometime, the optimal duration of cryoballoon ablation has not been determined. Moreover, the     biophysics of cryo-lesion formation suggests that repeated short freezes     (freeze-thaw-freeze cycles) may be more efficacious in achieving deep homogenous lesion     when compared to prolonged freezing durations. This grant proposal is to verify if repeated     short freezing cycles are more efficacious (i.e., fewer recurrence of AF), and safer, than     the established standard of long, single freeze cycles.   "
104866|NCT01913509|"     The investigators anticipate this research will shed light on metric properties of outcome     measures of pain and fatigue and the effects of the combined therapy for stroke patients. The     overall findings will contribute to guide the choice of proper assessment tool and the     development of effective rehabilitation programs.   "
104867|NCT01913496|"     The study is planned for people who would like to reduce or maintain their weight and keep a     healthy life style .After signing an informed consent, participants will be divided randomly     into two groups :control group and an intervention group that will get the application     (eBalance ). Participants will be followed for 12 weeks.   "
104868|NCT01913483|"     The primary objective of the study is to test whether anticoagulation with bivalirudin     results in fewer major bleeding complications compared with unfractionated heparin (UFH) in     participants undergoing peripheral endovascular interventions (PEI). The secondary objective     is to test whether there were potential benefits from bivalirudin therapy on other clinically     important events such as death, myocardial infarction (MI), stroke and/or transient ischemic     attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as     well as potential economic benefits that may result from improved clinical outcomes.   "
104869|NCT01913470|"     Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and     is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of     mortality and natural history studies of adults show that NAFLD is an independent risk factor     for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public health     standpoint, as it represents an early and possibly more aggressive form of the disease.     Currently there is no effective treatment for pediatric NAFLD.      Losartan is an orally-administered angiotensin II receptor antagonist which is currently on     the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has     been shown to be important in many disease states including renal disease, cardiovascular     disease, and NAFLD. Angiotensin antagonists are a class of medications that has been proposed     as a novel treatment of NAFLD in part because they would treat both the factors increasing     cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and hepatic     inflammation.      This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate     whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19 with     a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine     aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate     aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others.     Safety will be assessed by the recording of adverse events, clinical laboratory parameters,     vital signs and physical examinations.   "
104870|NCT01913457|"     Recently it has been shown that clear reproducible Doppler signals can be recorded from the     lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal     processing package parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung     Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from     the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves     typically have peak velocities of up to 30 cm/s and are of relatively high power, making it     possible to detect them despite the aforementioned attenuation by the air in the lungs. The     LDS are thought to represent the radial wall movement of small pulmonary blood vessels,     caused by pressure pulse waves of cardiac origin which propagate throughout the lung     vasculature. The LDS may contain information of significant diagnostic and physiological     value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular     system in general.      Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small     pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to     right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically     undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary     artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the     expertise of the individual carrying out the test. Therefore, the pulmonary arterial pressure     and cardiac output values have to be ascertained with a right-sided cardiac catheterization,     which is considered the gold-standard, but is invasive.      In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to     have the potential to diagnose pulmonary hypertension in two different ways: First, by     measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity     (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in patients     with PAH and control subjects.      One of the objectives of the present study is to evaluate the lung Doppler signals in     pediatric patients of various age groups, with and without pulmonary vascular disease. The     second objective of the study is to verify previous findings of abnormal lung Doppler signals     in adult patients with pulmonary hypertension.   "
123818|NCT01665313|"     The attention and clinical performance of physician might be decreased after outpatient     clinic session compared to those measured before outpatient clinic.   "
104871|NCT01913444|"     Maintenance of adequate anticoagulation or blood thinning is of critical importance when     patients are placed on extracorporeal life support, such as extracorporeal membrane     oxygenation (ECMO). During ECMO, a patient's entire blood volume is constantly exposed to the     artificial surfaces of the ECMO circuit. This exposure activates the clotting cascade, and     not only is the circuit at risk for clot formation, but the patient is also at risk for     clotting within the body. Hence anticoagulation is vital in allowing the ECMO circuit to     support a patient for an extended period of time. Anticoagulation on ECMO is achieved     primarily by the use of a blood thinning agent called heparin. Heparin's main mechanism of     action is to activate an enzyme called antithrombin III (AT III). AT III deficiency has been     shown to be a common finding in pediatric patients requiring ECMO. This deficiency may then     result in ineffective blood thinning by heparin. The purpose of this study is to determine     how a neonate on ECMO, processes and eliminates a medication called ATryn® from their body.     ATryn® is a form ATIII that is made from goat's milk. This will ultimately aid in     establishing standardized dosing for the use of ATryn® in this patient population.   "
104881|NCT01913314|"     This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has     been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring     radioactive form of the element carbon. This study will help understand how the drug appears     in the blood, urine, and stool after it is administered.      In addition, this study will also evaluate the safety and tolerability of a single dose of     LY2835219 when given to healthy participants. Information about any side effects that may     occur will also be collected.      This study will last about 3 weeks for each participant, not including screening.   "
104882|NCT01913301|"     The purpose of the study is to gather information regarding the safety and effectiveness of     an investigational drug called Alagebrium when used treating Heart Failure in relation to     exercise tolerance after 6 months in the trial.   "
104883|NCT01913288|"     The purpose of this RCT is to learn more about how sounds that we experience in the womb can     affect early development in premature infants. The investigators are specifically interested     determining whether and what types of maternal sensory stimulation can influence physical     growth, brain maturation, respiratory stability and early vocalization during postnatal     development. The investigators hypothesize that daily exposure to biological maternal sounds,     such as mother's voice and heartbeat, will improve both short-term and long-term     developmental in premature infants and will increase their potential to grow into healthy     children.   "
104884|NCT01913275|"     Periampullary carcinoma and carcinoma head of pancreas are common causes of obstruction at     the lower end of the common bile duct. Whenever possible, surgical resection in the form of     Whipple Pancreaticoduodenectomy (WPD) is the treatment of choice. However, this operation is     associated with a substantial postoperative morbidity and mortality. With advances in     surgical techniques and postoperative care there has been a decrease in the operative     mortality. However, the postoperative morbidity remains high varying between 5%-64%. Of the     various risk factors, the degree of jaundice as indicated by the serum bilirubin levels has     been associated with an increased risk of complications. Preoperative biliary drainage has     been tried to decrease the serum bilirubin levels and consequently decrease postoperative     morbidity and mortality. Internal biliary drainage can be achieved by surgical     cholecystojejunostomy or endoscopic bile duct stenting. Endoscopic stenting can be done as a     day care procedure under conscious sedation, but involves insertion of a foreign body     (stent), which results in introduction of bacteria into the bile and problems of     postoperative infection. Also, endoscopic stenting before surgery may result in difficulty in     dissecting around the common bile duct during the surgical procedure. While the surgical     bilioenteric bypass has the advantage that no foreign body is inserted into the biliary tree     and hence the likelihood of sepsis is low, it requires anesthesia and involves a surgical     incision.      There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in     patients undergoing pancraticoduodenectomy. We plan to compare the outcomes of preoperative     endoscopic biliary drainage with surgical drainage in patients undergoing     pancreaticoduodenectomy.   "
104885|NCT01913262|"     This is an observational registry intended to track depression scores of patients over time     in treatment.   "
104886|NCT01913249|"     The aim of this study is to compare short term (3 week) with long term (6 months) treatment     with seton prior to LIFT surgery. The main end-points are recurrence rates and complication     rates after surgery.   "
104887|NCT01913236|"     Background The prevalence of depression is high and the elderly have an increased risk of     developing a chronic course. International data suggest that depression in the elderly is     under-recognised, the latency before clinicians provide a treatment plan is longer, and     elderly patients with depression are not offered psychotherapy to the same degree as younger     patients. Although recommendations for the treatment of elderly patients with depression     exist, health care professionals adhere to these recommendations to a limited degree only.     Investigators conducted a systematic review to identify recommendations for managing     depression in the elderly and prioritised six recommendations. Investigators identified and     prioritised determinants of practice related to implementation of these recommendations in     primary care, and subsequently discussed and prioritised interventions to address the     identified determinants. The objective of this study is to evaluate the effectiveness of     these tailored implementation interventions to implement six recommendations for the     management of elderly patients with depression in primary care.      Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing     implementation of the six recommendations using tailored interventions with usual care.     Investigators will randomize 80 municipalities into one of two groups: an intervention group,     to which investigators will deliver tailored interventions to implement the six     recommendations, and a control group, to which investigators will not deliver any     intervention. Investigators will randomise municipalities rather than patients, individual     clinicians or practices because we will deliver the intervention for the first three     recommendations at the municipal level and investigators want to minimise the risk of     contamination across practices for the other three recommendations. The primary outcome is     the proportion of general practitioners' behaviours which are consistent with the     recommendations.      Discussion This trial will investigate whether a tailored implementation approach is an     effective strategy to improve collaborative care in the municipalities and health care     professionals' practice towards elderly patients with depression in primary care. The     effectiveness evaluation described in this protocol will be accompanied with a process     evaluation exploring why and how the interventions were effective or ineffective.   "
104913|NCT01912898|"     Lack in vitamin D reduces the absorption of calcium in the body; accelerates bone loss tnd     may increase the risk of fractures due to osteoporosis. An algorithm that will allow     immadiate and non -invasiv quanification of vitamin D levels will shorten the time of     diagnosis; reduce lab costs and prevent hazards or discomfort to patient associated with a     blood test.      The goal of the study is therfore to develop a non invasive method for quanitifying vitamin D     levels in the body using specroscopy.      40 subgects will be recruited: 20 hospitalized patients in the endocrinology departmet,     diagnosed with vitamin D deficiency. and 20 healthy subjects. Spectroscopy will be used with     wisible lighy on the subject's skin and middle infrared (MIR) on the blood sample to find     correlation with the chemical lab test results.   "
104888|NCT01913223|"     ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial     neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of     the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2)     circumferential (complete or partial) incision and 3) dissection of the submucosa. Several     tools are necessary to perform ESD with the standard technique. Development of water jet with     bi functional (injection and cutting) catheter allows time and significant reduction of     perforation risk (due to multiple changes of instruments). For this purpose, Nestis     introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently     and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies     indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are     possible. In addition, preclinical studies on living pig colon models using saline solutions     have demonstrated that perforation rates and operating times are significantly reduced     compared to a standard electrosurgical knife. The present clinical study is being performed     to confirm this system capability to perform ESD in humans.   "
104889|NCT01913210|"     To determine the effect of ginseng on blood pressure control.   "
104890|NCT01913197|"     In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate to     treat the entire gland. This is done because, in the past, it was impossible to know where     the cancer was located within the prostate. Multiparametric magnetic resonance imaging (MRI)     can identify tumor(s) with a high degree of accuracy. This trial will assess whether using     MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing lower     doses to be delivered to the regions of the prostate without tumor while simultaneously     allowing higher doses to the tumor. Subjects enrolled in this study will then be followed     over two years and evaluated for toxicity. In addition, after two years they will undergo an     MRI and a biopsy to assess the cancer control rate of the treatment.   "
104895|NCT01913132|"     The wound infection rate in the groin after vascular surgery has been denoted to be high     since the wound surveillance register started in 2005. The current wound infection rate based     on a validation study was 22.9% (24/105 patients with groin incision(s) between 1 March to 30     June in 2012). The Deep/superficial infection ratio was 7/17. To prove that PICO (negative     wound pressure therapy) reduces the wound infection rate with ½ standard deviation, 90% power     at the 5% significance level, inclusion of 160 patients, 80 patients in the PICO Group and     the standard dressing group are needed.   "
104896|NCT01913119|"     Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and     poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal     NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for     cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory     peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval     24%-53%). The median duration of overall response was 8.9 months. Considering the median     number of previous treatments in these patients was three (range 1-11), romidepsin has single     agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent     activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with     salvage treatment.   "
104897|NCT01913106|"     The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical     studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with     brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach     to prostate cancer and hopefully impact on the development of metastatic disease and the     control of preexisting metastasis.   "
104898|NCT01913093|"     To find possible therapeutic targets to help prevent long-term brain and behavioural side     effects in survivors of childhood leukemia that may have been caused by chemotherapy     (Treatment-Related late Adverse Neuro-Cognitive Effects: TRANCE). The study hypothesis is     that genetic variations of the elements in the folate-related cycles and methotrexate     disposition networks are associated with the TRANCE phenotype of childhood leukemia     survivors.   "
104899|NCT01913080|"     The goal of the present study is to determine if a health management tool improves     self-efficacy, satisfaction with the doctor's visit, and agreement of the statement How     satisfied are you that your concerns were addressed during your clinic visit today over     time.   "
104900|NCT01913067|"     A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast     and non-small-cell lung cancer (NSCLC).      OBJECTIVES:      Primary:      The purpose of this study is to determine if cabazitaxel can induce a reduction in the size     brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis     who were not previously treated with whole brain irradiation or require immediate brain     irradiation.      Secondary:        -  To determine the effect of cabazitaxel on the time to initiating whole brain irradiation          or radiosurgery        -  To determine the effect of cabazitaxel on the time to developing neurological symptoms        -  To determine the effect of cabazitaxel on the time to disease progression in the brain        -  To determine the effect of cabazitaxel on the time to disease progression outside the          brain. This will be evaluated separately for the breast and NSCLC cohorts To determine          the objective extra-cranial response (if applicable). This will be evaluated separately          in the breast and NSCLC cohorts        -  To determine the safety of cabazitaxel   "
104924|NCT01912755|"     The aim of this study was to verify the effectiveness of an anesthetic called articaine for     dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine.     Two types of local anesthesia (oral injection) in accordance with the solution used were     performed. For patients anesthetized with articaine, an injection of anesthesia close to the     tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the     bottom of the mouth was made. Differences between both techniques are mainly regarding the     area of numbness. In the injection with articaine only a small part of the lip and the tooth     was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth     and half of the tongue on the same side was numbed. The treatment was electronic randomized     and there was equal chance to one or another treatment. The investigators are studying this     new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to     an emergency treatment, if it really decreases the feeling of numbness and discomfort during     the service. Patients receiving articaine were submitted to cone beam exam at no cost.   "
104901|NCT01913054|"     Gastroscopy, as a conventional examination for gastrointestinal tract disease, plays a very     important role especially in early diagnosis and differential diagnosis of esophageal and     gastric carcinoma. However, conventional gastroscopy is associated with several adverse     effects (including throat discomfort, breath-holding, nausea, vomiting, laryngeal spasm and     increased heart rate) due to which some patients are intolerant to this examination or even     refuse the procedure due to fear of these effects. Recently, painless gastroscopy has been     applied increasingly widely in outpatients to meet the increasing needs for comfortable     medical care.      Painless gastroscopy is commonly performed under general anesthesia without establishing an     artificial airway. This is associated with an even higher anesthetic risk than general     anesthesia in the operating room due to more basic patient monitoring and life-supporting     equipment, only one anesthetist to perform anesthesia, fatigue in anesthesia, the requirement     for a high turnover rate, as well as limited understanding of a patient's condition.     Therefore, the availability of sedatives and analgesics which can provide rapid onset,     sufficient sedation and analgesia, a short recovery time and less adverse effects are the     premise of performing painless gastroscopy. Currently, combined intravenous anesthesia with     fentanyl and propofol, commonly used in the clinic, is still associated with a long duration     of action, hypotension in some patients and prolonged recovery. Etomidate has been     increasingly utilized for in-clinic diagnosis and treatment for procedures such as painless     coloscopy and early induced abortion due to its rapid onset, rapid metabolism and minimal     impact on the circulatory and respiratory systems. However, no study on combined intravenous     anesthesia with fentanyl and etomidate for painless gastroscopy had previously been reported.     The main purpose of this study is to explore the efficacy and safety of combined intravenous     anesthesia with fentanyl and etomidate for painless gastroscopy compared with the combination     of fentanyl and propofol in middle aged and elderly patients, and to provide reliable     evidence for the implementation and promotion of comfortable medical care.   "
104902|NCT01913041|"     -  The purpose of this study is to understand and grasp the incidence rate of hypothermia          during perioperative period of elective operations under general anaesthesia in Beijing.        -  The purpose of this study is to carry out a subgroup analysis on the survey data and          explore the high-risk factors for the incidence of hypothermia.   "
104903|NCT01913028|"     The purpose of this study is to assess safety, tolerability, pharmacokinetics and     immunogenicity of MEDI9929 following administration of single ascending doses in healthy male     Japanese subjects.   "
104904|NCT01913015|"     This randomized pilot phase I trial studies the side effects of dietary fat levels and     abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer.     Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone     acetate.   "
104905|NCT01913002|"     This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000     mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.   "
104906|NCT01912989|"     The purpose of this study is to investigate if a brief, motivational interviewing     intervention (NOURISH+MI) can improve retention and treatment adherence for parents enrolled     in an intervention for their child's overweight (NOURISH+). The investigators hypothesize     that children whose parents participate in NOURISH+MI will demonstrate lower attrition and     greater adherence with NOURISH+, ultimately leading to greater treatment effects, compared     with children whose parents are randomized to NOURISH+ or a control group.   "
107182|NCT01883141|"     The purpose of the iSPOT Study is to evaluate the contractility using positive left     ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac     resynchronization therapy (CRT).   "
104907|NCT01912976|"     Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is an effective treatment for Bowen's     disease (BD) of the lower extremities. Er:YAG ablative fractional laser (AFL) treatment     removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no     studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in     treating BD of the lower extremities in Asians.   "
104908|NCT01912963|"     In this study, the investigators are testing the effectiveness of the combination of     eribulin, pertuzumab and trastuzumab to learn whether this combination of drugs works in     treating advanced HER2-positive breast cancer that had received at least one prior treatment     previously. At this point, the standard treatment for HER2-positive cancer that has     progressed (grown) after a first treatment is chemotherapy combined with therapies that     target the HER2 protein (e.g., trastuzumab or lapatinib).      All of the medications that are being tested in this study are approved by the Food and Drug     administration (FDA) for the treatment of metastatic breast cancer. However, the combination     of these three medications in participants has not yet been tested. Eribulin is a     chemotherapy agent that is approved for the treatment of metastatic breast cancer for women     who have previously received at least two prior chemotherapeutic regimens for the treatment     of their metastatic disease. Pertuzumab and trastuzumab are also both approved for the     treatment of advanced HER2-positive breast cancer. Both agents help treat breast cancer by     binding HER2 receptor. However, pertuzumab and trastuzumab bind to different parts of the     HER2 receptor.      The goal of this research study is to find out if adding pertuzumab, trastuzumab and eribulin     is effective in treating women with metastatic, HER2-positive breast cancer. The     Investigators, will also gather more information on the side effects of these treatments      The investigators also plan to gather genetic information from participants' tumors     (collected at biopsies). Cancers occur when the molecules that control normal cell growth     (genes and proteins) are altered. Changes in the tumor genes and in the genes of normal cells     are called alterations. Many of these alterations can be detected by directly examining     cancer cells in a tumor or circulating in blood. Several alterations that occur repeatedly in     certain types of cancers have already been identified. These discoveries have led to the     development of new drugs that target those alterations. More remain to be discovered.      Some of the alterations are found in genes. Genes are composed of DNA letters, which     contain the instructions that tell the cells in our bodies how to grow and work. Genes make     proteins which actually carry out the instructions in our cells.      The investigator would like to use your DNA to look for alterations in the genes in cancer     cells and blood cells using a technology called sequencing. Gene sequencing is a way of     reading the DNA to identify errors in genes that may contribute to the behavior of cells.     Some changes in genes occur only in cancer cells. Others occur in normal cells as well, in     the genes that may have been passed from parent to child. This research study will examine     both kinds of genes.      One of the scientific goals of this research study is to perform gene sequencing (gene tests)     on your cancer cells (obtained from biopsies or surgery) and normal tissues (usually blood).     The results of the gene tests will be used to try to develop better ways to treat and prevent     cancers. As part of this work, we may also learn things about the genes in your normal cells.     However, because interpretation of these tests will require further study,the investigator     will not disclose these results to participants who participate on this component of the     study.   "
104909|NCT01912950|"     The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety     and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body     hair.      Subjects will have a designated treatment area on one forearm divided into four equal-size     quadrants. One quadrant will serve as the un-treated control area and the other 3 quadrants     will be treated with the Cutera Prowave LX IPL. Subjects will receive 3 IPL treatments,     spaced 8 weeks apart, on the designated area and will be followed at 12-weeks post-final     treatment.   "
104910|NCT01912937|"     To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel     coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or     restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).   "
104911|NCT01912924|"     A study for patients who have chronic postoperative pain who had knee replacement surgery. If     qualified, a 14 day trial and an implantation of spinal cord stimulator for control of pain     will be administered. This study will evaluate effectiveness of pain control. Subjects will     be followed for one year post implantation.   "
104962|NCT01912248|"     Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac     patient, how high?   "
109457|NCT01853293|"     This research is designed to assess if problem drinking by treatment seeking individuals can     be treated (reduced) by kudzu extract pharmacotherapy plus medical management therapy.   "
104914|NCT01912885|"     INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society     as urgency, with or without incontinence, usually with increased urinary frequency and     nocturia. It is difficult to estimate the prevalence of this syndrome because many patients     do not seek medical help, despite considerable negative impact on quality of life. Lower     urinary tract dysfunctions can be treated using electrical stimulation of the posterior     tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion     to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary     frequency and nocturia . Due to lack of consensus on the parameters of this technique,     further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the     electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic     overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will     accept up to 145 women with overactive bladder diagnosis for at least six months prior to the     beginning of the study. The subjects will be divided into five groups: group 1 (placebo     group), group 2 (electrical stimulation of one leg once a week), group 3 (electrical     stimulation of one leg twice a week), group 4 (electrical stimulation of two legs one a week)     and group 5 (electrical stimulation of two legs twice a week). Physical evaluation will be     done at the beginning and at the end of the treatment. Evaluation will be done using the King     s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short     Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for     follow-up treatment.   "
104915|NCT01912872|"     To assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the     use of inhaled corticosteroid (ICS) in pediatric and adult patients with severe IgE-mediated     asthma inadequately controlled with high doses of corticosteroids.   "
104916|NCT01912859|"     The purpose of Next Steps pilot intervention is to develop and test a new program designed to     help low-income multiethnic families with overweight or obese children achieve long-term     maintenance of healthful behaviors following completion of Hennepin County Medical Center's     (HCMC) 16-week intensive obesity management course (Taking Steps Together (TST)).   "
104917|NCT01912846|"     The purpose of this 5-year interventional study is to design, implement, and evaluate the     effectiveness of an intervention aimed at facilitating prognosis communication and     end-of-life care decision-making to increase the extent of congruence between the patient's     preferred and actual EOL care received and patients' and family caregivers' QOL and     psychological well-being, reduce futile aggressive healthcare resources utilization at     end-of-life, and facilitate bereavement adjustment.   "
104918|NCT01912833|"     The purpose of the funded study is to determine a) examine associations among OT levels,     stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess     whether there are differences between immigrant women and non-immigrant Latina women on these     measures; b) quantify whether there is a correlation between ACTH, cortisol, and PPD and     whether there are differences between immigrant and non-immigrant Latina women; and c) assess     the feasibility of enrolling Latinas into a laboratory-based study that includes the     collection of venous blood for measurement of oxytocin, ACTH, and cortisol. Sixty prenatal     (34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are between the ages of 18 and     45 will be enrolled. Women with a singleton pregnancy who are Latina, who intend to     breastfeed for more than 2 months, who have or do not have a history of depression, and who     are willing to be followed for 8 weeks after delivery will be enrolled in the study. Latinas     who report maternal or infant disorder that may interfere with breastfeeding; those who     endorse substance use, and/or who have or have had a psychiatric disorder (e.g., psychosis or     serious personality disorders) other than depression or anxiety will be excluded to minimize     risk and confounds with the outcomes of interest.   "
104919|NCT01912820|"     This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green     tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical     prostatectomy. Side effects of green tea extract and quercetin in combination with green tea     extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer     and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies     quercetin was found to enhance the anticancer effects of green tea. This trial is designed to     translate these findings forward in a short-term human intervention trial.   "
104920|NCT01912807|"     The aim of this study was to investigate the efficacy of intraoperative intravenous dextrose     in preventing POV in pediatric population undergoing dental day surgery.      Post-operative vomiting (POV) in children is a frequent complication. Studies using     intravenous (IV) fluids containing dextrose in the perioperative period have shown     improvement of POV in adults. Similar studies have not been done in children.      Knowing that Intravenous (IV) fluids containing dextrose are safe and commonly used in the     paediatric population, this intervention could potentially reduce the amount of rescue     antiemetic medications and improve recovery in same-day surgery paediatric patients.   "
104921|NCT01912794|"     To maintain stable body balance in daily activities, the ability to respond to external     perturbations is an essential factor. Such capacity is limited in pathological conditions,     such as in stroke, in which postural control is impaired due to lesions to the central     nervous system. Impairment to postural control increases body sway during upright posture and     leads to augmented frequency of falls. In this sense, the identification of mechanisms     involved in body balance disorders after stroke is particularly important in situations of     postural perturbation. The purpose of this project is to evaluate reactive postural responses     to unpredictable external perturbations, analyzing postural dysfunctions caused by lesion to     different brain areas as a result of stroke, and test principles of dynamic body balance     rehabilitation.   "
104922|NCT01912781|"     The purpose of this study is demonstrate substantial equivalence of an investigational     contact lens disinfecting solution to a commercially available contact lens solution in gas     permeable lens wearers.   "
104923|NCT01912768|"     The purpose of this study is demonstrate substantial equivalence of an investigational     contact lens disinfecting solution to a commercially available contact lens solution in     silicone hydrogel and soft contact lens wearers.   "
104990|NCT01911871|"     The investigators' primary objective is to study prevalences of myocardial iron overload,     defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected     with thalassemia, sickle cell disease, and myelodysplasia.   "
104925|NCT01912742|"     Obesity has become a global epidemic with huge public health implications. Although clinical     significant weight loss (WL) can be achieved by a combination of diet and behavioral     modification, strong metabolic adaptations, with increased appetite and suppressed energy     expenditure, are activated, which compromise WL maintenance and increase the risk of relapse.     The aim of this project is to investigate the potential role of WL rate in modulating such     responses. More specifically, the investigators want to determine if a similar WL achieved     rapidly vs slowly induce the same compensatory responses to weight reduction. A secondary aim     is to assess if speed of weight loss can influence motivation. A large battery of assessments     will be performed before and after weight reduction including body composition, resting     metabolic rate, substrate oxidation, exercise efficiency, fasting and postprandial release of     several appetite-regulating hormones, subjective feelings of hunger and fullness and     motivation. This project can bring large practical benefits concerning the design of weight     loss programs to minimize weight relapse.   "
104964|NCT01912222|"     This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or     hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate     hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute     (NCI) Organ Dysfunction Working Group.   "
104926|NCT01912729|"     The mission of this project is to develop novel systems of care that can provide efficacious,     scalable, cost-effective, participant friendly behavioral intervention technologies (BITs)     for the prevention of depression in adolescents. The investigators define BITs as     interventions that use information and telecommunications technologies such as the internet,     mobile or traditional phones, computers and/or other technologies to support and deliver     psychological and behavioral interventions. Through usability testing, focus interviews, and     field trials, investigators may modify the technologies and intervention based on immediate     usage data.   "
104927|NCT01912716|"     It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of     100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of     the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk     patients. However, the optimal dose required is not known. The purpose of this study is to     determine whether a dose of 200 mg, administered as rectal suppositories, is more effective     than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube     with a camera is passed down the patient's throat and allows for evaluation of the bile duct     and/or pancreatic duct. The most common side effect of this procedure is post-ERCP     pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this     complication than others. Our hypothesis is to compare the efficacy of these two dose     regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the     frequency and severity of post-ERCP pancreatitis in high-risk patients.   "
104928|NCT01912703|"     It is well-known that preterm delivery can be accompanied by complications. One of these     complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according     to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes,     including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social     difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim     of this study is to determine whether they do have any neurodevelopmental outcomes.   "
104929|NCT01912690|"     The hypothesis of the study is that aerobic conditioning following acute heart attack will     improve autonomic function and electrical stability of the heart.   "
104930|NCT01912677|"     This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive     regimens for women with severe hypertension in pregnancy. Women presenting with severe     hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of     three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the     efficacy, safety and side effects of these three oral regimens for management of hypertension     in pregnant women. The investigators hypothesize that nifedipine treatment of severe     hypertensive parturient women is more effective than treatment with labetalol or methyldopa     in controlling high blood pressure within six hours.   "
104931|NCT01912651|"     Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of     wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve     the healing of skin grafts and reduce the risk of infections after surgery in these patients.     It is known that antibiotics, like all medications, have side-effects although these are     rare. This research study is designed to show us whether antibiotics improve wound healing or     not, so that we may determine if we should continue using antibiotics even if they have     side-effects in some patients.      Our hypothesis is that patients treated with post-operative, systemic antibiotics will     demonstrate a statistically significant improvement in the survival of their facial full     thickness skin grafts compared to patients who are not treated with systemic antibiotics.   "
104932|NCT01912638|"     The purpose of this prospective randomized study is to assess and compare the clinical     efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive     viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled     steroid induced glaucoma.   "
104933|NCT01912625|"     This phase I trial studies the side effects and the best dose of trametinib when given     together with combination chemotherapy and radiation therapy in treating patients with stage     III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving     trametinib, combination chemotherapy, and radiation therapy may be a better treatment for     non-small cell lung cancer.   "
104961|NCT01912261|"     The purpose of this research study is to examine how an oral iron supplement (Feramax®)     influences fatigue during early postoperative recovery (at three months) among CABG patients     and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia, and     medication adherence).      It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally     (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence     Fatigue Scale (ICFS)), compared to patients receiving a placebo.   "
104935|NCT01912599|"     Purpose: To study the feasibility of a larger study by determining the tolerability of     measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory     fashion with automatic devices.      Participants: 20 patients with moderate to severe normal tension glaucoma and 20     non-glaucomatous patients.      Procedures (methods): Both BP and IOP will be measured automatically in each participant in     an ambulatory fashion during a 24-hour period. BP will be monitored using an appropriately     sized cuff Oscar 2 (Suntech Medical, Morrisville, NC), which will be placed by a person     trained in ambulatory BP monitoring devices. The device will be set up to automatically     inflate every 30 minutes during the day and every hour during the night to measure and record     the BP. IOP will be measured using Sensimed Triggerfish contact lens (Sensimed AG, Lausanne,     Switzerland); the measurements will be taken and recorded every 10 minutes. The contact lens     will be inserted by eye doctors (investigators). Both monitoring devices will be removed the     following day.   "
104936|NCT01912586|"     Although the high prevalence of erectile dysfunction (ED) was detected among male patients     after the treatment for colorectal cancer, published reports depicting the erectile     dysfunction experience of patients with colorectal cancer ot underpin service development are     insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal cancer     are not routinely offered information and treatment for erectile dysfunction.However,     investigations on patients after surgery for prostate cancer could provide some potentially     useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the     return of erections after nerve-sparing radical prostatectomy has been established, which may     benefit rectal cancer patients after surgery with ED.      Laparoscopic surgery, although technically demanding and associated with a long learning     curve, has the advantage of clear visualization for the smallest structures,including the     autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate preservation     of the pelvic autonomic nerves.      This study aimed to identify whether early intervention is effective at reducing the rate of     ED at 12 months.   "
104937|NCT01912573|"     The goal of this study is to determine if nasal naloxone is inferior to standard care for     naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and     Scioto counties in southern Ohio will be randomized to provide either standard care or nasal     (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes     administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO)     methods.   "
104938|NCT01912560|"     The purpose of this study is to determine the safety and efficacy of different doses of     CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will     evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with     moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in     patients with hypercholesterolemia who are on a statin.   "
104939|NCT01912547|"     Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve     significant blood loss with considerable blood and product transfusion. Thromboelastography     (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that     records kinetic changes in clot formation. This study aims provide a better understanding of     the coagulation profile of these patients, and will form the basis of a TEG-based transfusion     algorithm for future surgeries for mesothelioma.   "
104940|NCT01912534|"     The purpose of this trial is to determine whether treatment with valsartan will have     beneficial effect in early hypertrophic cardiomyopathy (HCM) by assessing many domains that     reflect myocardial structure, function and biochemistry.   "
104941|NCT01912521|"     This pilot study is a non-randomized controlled cohort study evaluating the impact of social     network-based HIV education on antiretroviral therapy (ART) adherence, clinical outcomes,     food security, social support, HIV knowledge, and risk behaviors among people living with     HIV/AIDS, as well as members of their associated social support networks. The intervention,     known as the Mfangano Health Net Microclinic Pilot Program, consists of a 6-month education     program on HIV biology, interpersonal communication and community mobilization for both HIV     positive individuals and their self-selected social network members selected irrespective of     HIV status. Investigators hypothesize that participation in the microclinic program will     improve ART adherence, cluster of differentiation 4 (CD4) count, social support, HIV     knowledge and food insecurity and will reduce HIV-related stigma, as compared to participants     in control communities.   "
104942|NCT01912508|"     Cervical length is a already known predictor for preterm labor. In this study the     investigators want to examining the hypothesis that cervical curvature is also a predictor     for preterm labor and that moderate transducer pressure influence cervical length.      study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound     unit ether for routine screening or because of preterm labor.      During their examination cervical length and curvature measurements will be taken. Another     measurement will be taken after applying moderate cervical pressure.      The investigators will compere cervical contour and pressure influence between groups and     according to cervical length Demographic data will be taken at the time of recruitment and     pregnancy outcome measures in a later telephone interview.   "
104943|NCT01912495|"     Prospective open label proof of concept feasibility interventional clinical trial in which 60     acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in     addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at     week 4.      The primary hypothesis of this study is that the subset of patients with a Rapid Viral     Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and     ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.   "
104944|NCT01912482|"     The cardiorespiratory training can increase muscle strength ventilatory.   "
104945|NCT01912469|"     To investigate and compare the effects of Traumeel®S tablets versus placebo on exercise     induced muscle damage and muscle soreness for 72 hours after strenuous eccentric exercise     test on downhill treadmill.   "
104963|NCT01912235|"     Arginine synthesis in mammals is a complex process involving at least 8 enzymes and     intracellular and interorgan transfer of substrates.      The investigators have shown in our neonatal studies that there is no conversion of glutamate     to arginine but proline label appears in ornithine, citrulline and arginine. It is clear     therefore that arginine is synthesized in human neonates from proline.      In adults the source of the carbon backbone is less clear.   "
104946|NCT01912456|"     The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing     hereditary angioedema attacks when it is administered under the skin of subjects with     hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each     subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period     and who are eligible will then enter the treatment phase which comprises two sequential     treatment periods. In the treatment phase, subjects will be randomized to one of four arms     consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment     period and treatment with low- or higher-volume placebo in the other treatment period. The     study will measure the number of hereditary angioedema attacks that subjects experience while     receiving each treatment.   "
104947|NCT01912443|"     To assess the safety profile of bevacizumab in combination with chemotherapy for the     treatment of metastatic colorectal cancer   "
104948|NCT01912430|"     New payment methods such as Accountable Care Organization (ACO's) and medical homes     facilitate are new models for providers to deliver cost effective, quality patient outcomes.     Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic     interventions with an intelligent information technology platform that offered validated     protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated     program of Integrated Care Coaching (ICC), which was branded as VitalCare, and implemented     with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare     costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for     participants.   "
104949|NCT01912417|"     The aim of this study is to evaluate the effect of aerobic exercise during dialysis on the     hemodialysis efficacy in the removal of small molecules measured by continues spend sampling     of dialysate (liquid metabolites produced by the body which is disposed) technique.   "
104950|NCT01912404|"     The main purpose of the study is to test if taking a study drug called emricasan (also known     as IDN-6556 and PF-03491390) will affect overall patient survival after one month of     treatment.   "
104951|NCT01912391|"     Selegiline is superior to placebo in improving psychological and physical functioning in     patients with Borderline Personality Disorder.   "
104952|NCT01912378|"     The study will investigate the effects of an intranasal administration of oxytocin (OT) to     parents of children with autism spectrum disorders (ASD) on the quality of     mother-father-child interactions. Physiological and behavioral measures of parent-child     triadic interaction quality will be assessed.      H1: Parents who receive OT will demonstrate greater parental engagement and nonverbal     prosocial behaviors compared to parents who receive placebo.      H2: Children with ASD whose parents receive OT will have increased nonverbal prosocial     behaviors during the discussion and play tasks compared to children whose parents' receive     placebo.      H3: Parents who receive OT will demonstrate increased behavioral and physiological synchrony     with their child during the discussion and play tasks compared to parents who receive placebo     and their child.   "
104953|NCT01912365|"     Elbow fractures are very common in young children. Type I supracondylar fractures are stable     fractures to the elbow that are treated conservatively across the world and typically heal     very well without complications. There are several treatment options, including an above     elbow cast or long arm splint. This study aims to determine if one treatment is no worse than     the other in order to standardize the treatment of these fractures at our institution. The     investigators hope to save families from extra hospital visits and reduce the amount of     x-rays required for treatment of these fractures.   "
104954|NCT01912352|"     The aims of the current study are to examine gene-environment interactions associated with     norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic     changes in norepinephrine pathway are associated with differences in functional connectivity     of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore,     this study aims to examine neurobiological markers, such as intermediate neuroimaging     phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD.     Through evaluating drug responses and side effects with the associated measures of clinical,     neuropsychological and neuroimaging characteristics, investigators would like to investigate     predictors of treatment response associated with NE system genes in ADHD.   "
104955|NCT01912339|"     To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary     symptoms secondary to benign prostatic hyperplasia (BPH).   "
104956|NCT01912326|"     Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to     prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with     optimized pacemaker programming.      Hypothesis:      Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to     programming DDDR-(60) without AF Suppression when all other parameters are optimized.   "
104957|NCT01912313|"     Rectal biopsies from IBS patients or healthy subjects will be taken.      Biopsies will be used for:        1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium          imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and          real time PCR (Polymerase chain reaction);        2. culturing biopsies      On the basis of these observations, the general aim of the study is to move a significant     step forward in the current knowledge on human ENS (enteric nervous system) in IBS by     establishing a live imaging method to record enteric nerves activity in small intestinal     biopsies from humans. This development is unique in its kind as not other research groups     have reported successful live recordings with calcium imaging in this preparation.      In particular, the investigators aim:        1. to develop and validate the technique to measure activity in human enteric nerves in the          submucous plexus isolated from rectal biopsies from healthy subjects and IBS patients;        2. to characterize this nerve activity in healthy subjects and IBS patients using both          calcium imaging to evaluate the effect of different neuromodulators,          immunohistochemistry and rtPCR to determine receptor expression levels and identify          neurons and glial cells in the submucous ganglia;        3. to investigate whether the biopsies of IBS patients secrete more modulators/cytokines          compared to healthy subjects and their potential to activate neurons.        4. to evaluate the influence of different food constituents (cow‟s milk, wheat, yeast,          gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell          activation/degranulation in biopsies of IBS patients compared to healthy subjects.        5. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS          patients and healthy volunteers by the use of metabolic profiling   "
104958|NCT01912300|"     Sedentary behaviors have been shown to increase food consumption among youth and adults. The     recent active video games devices have been suggested to compensate for the increased energy     intake they induce by the increased energy expenditure they generate. To date no study has     been conducted to question whether or not such modern sedentary activities induce energy     consumption modification in youth. The aim of this work is to compare the impact of a passive     video games vs. active video games vs. physical exercise in terms of subsequent energy intake     and appetite feelings in normal weight and obese youth.   "
104965|NCT01912209|"     The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of     Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular     disease. Second, the investigators wish to encourage a healthy lifestyle through personalized     nutrition and fitness advice, delivered as part of a web based program, which will in turn     lead to increases in heart healthy behaviors such as increased consumption of heart healthy     foods, increased exercise initiation, and more positive attitudes about health. To assess     this, the investigators plan to randomize 200 employees with Metabolic Syndrome to either the     new web-based diet and lifestyle program, or to care-as-usual, which is the currently offered     MyWellnessAdvantage and WebMD websites. The investigators hypothesize that the web-based     group will show greater improvements in physical health (such as weight loss, cholesterol     reduction, etc.) as well as increased consumption of heart healthy foods, exercise     initiation, and quality of sleep as measured by surveys administered at the 4,8, and 12 month     follow-up appointments.   "
104966|NCT01912196|"     The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in     reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate     response to current antidepressant therapy.   "
104967|NCT01912183|"     This is a pilot study to examine the feasibility of implementing an objective physical     activity and sleep monitoring tool into a pediatric weight management program in conjunction     with a personal health record (PHR) for children and their families. This feasibility study     is intended to provide proof of concept in the incorporation of monitoring devices within the     PHR for pediatric patients and their families. Additionally, the investigators will examine     whether the PHR helps to empower pediatric patients, their families and the health care team     to more effectively monitor the patient's behavior change. Participants will be randomized to     receive, or not receive, augmented communication with the health care team between clinical     in person visits.   "
104968|NCT01912170|"     This study is to examine the change of fasting insulin, glucose, insulin sensitivity and     related traits in response to the 14 wk treatment of omega-3 fatty acids, including fish oil     (n=25) and flaxseed oil(n=25), in Chinese gestational diabetic patients. Corn oil(n=25), rich     in omega-6 fatty acids, will be selected as a controlled oil. The intervention will start     from the third trimester of these pregnant women and finish at the 4wk after the birth of     their children. The investigators hypothesize that omega-3 fatty acids could improve insulin     sensitivity and glucose metabolism in these patients.   "
104969|NCT01912157|"     Handling of complex health situations (as defined by multimorbidity) in partnership:     communication between romantic partners; subjective illness perception; coping with stressful     experiences due to multimorbidity.      Intervention : Expressive Writing about subjective illness perception vs. Writing about     individual Time-Management Primary Endpoint: subjective Health (e.g. SF 12 questionnaire)     Secondary Endpoints: Psychosocial Adjustments (Depression, somatic symptoms, quality of     partnership and others)   "
104970|NCT01912144|"     Phenolic acids are naturally-occurring constituents of plant-derived foods and beverages and     are characterised by a phenol ring in their structure. The phenolic compounds we are going to     focus on in this study are the Chlorogenic acids (CGAs), a family of esters conjugates formed     between a Hydroxycinnamic acid and quinic acid (1) and that show a strong antioxidant     activity (2).      HCAs represent about 50% of the total polyphenolic coumpounds intake in a typical UK diet (3)     and for people who drink it, coffee is a/the major dietary source of/for HCAs (4). A few     studies suggest protective effects for cardiovascular diseases (5), neurodegenerative     diseases, type 2 diabetis and liver and kidneys cancer risk. However, many data in the field     are obtained from in vitro and/or in animal, and it is difficult and dangerous to extrapolate     between these and risk in humans of development or progression of particular health     conditions, more human studies are therefore needed.      We aim to compare people that metabolise the best CGAs from coffee to those that metabolise     them the least well. This will be achieved by measuring the metabolites in urine. The effect     of CGAs on the human body does not only depend on the amount ingested, but also on the     quality of the metabolism, we therefore also want to determine which mechanisms are     responsible for inter-individual variations in order to identify any link with health     biomarkers, these including non-cellular inflammation and cardiovascular risk indicators.      For this cohort study funded by the University of Leeds, approximately 60 healthy volunteers     will be recruited at the School of Food Science & Nutrition. If they meet the selection     criteria, participants will be asked to undergo a 36-hour wash-out period. During those 36     hours, participants won't be allowed to drink coffee, they will be asked to follow a diet low     in phenolic acids and keep a record of their meals. On the first day of the study, a single     dose of coffee rich in antioxidants will be given to the participant and urine will be     collected from that time until 36 hours after coffee consumption. Participants will be     followed again after 5 to 6 weeks.   "
104971|NCT01912131|"     This study is being done to get individuals' feedback on advanced care planning and decision     making.      This study is divided into two parts (Part 1 and Part 2). The purpose of Part 1 is to survey     people to find out what is important to people with advanced cancer (again, their values,     such as their goals, concerns and sources of support). This has never been done before in the     way the investigators are doing it, and that is why this is called a pilot study, which is     where a new method or treatment is being created and evaluated.      The purpose of Part 2 is to see if combining a medical options video with a short interview     about values helps people with how they feel about their medical situation, and what they     know about their medical options for their medical situation.   "
104972|NCT01912118|"     Despite various efforts there is still the need for adequate monitoring of pain and     nociception during anesthesia. In a previous protocol the investigators measured pain     responses during anesthesia based on single end‐points, eg heart rate,blood pressure and     pulse transit time. None of these parameters provided sufficient information regarding     nociception. The investigators therefore want to further investigate this matter using a     composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the     magnitude of the autonomic response to painful stimuli. The NoL combines information from     several physiological parameters, which represent different autonomic pathways. The     multi‐parameter approach empowered with state‐of‐the‐art signal processing and machine     learning techniques. In the current study the investigators will measure the NoL in ASA 1‐3     patients undergoing elective surgery under general anesthesia. The investigators will measure     NoL responses and the occurrence of patient movement upon the administration of a painful     stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of     the gastric tube, Insertion of the bladder catheter and Skin incision.   "
104973|NCT01912105|"     Cleaning the endotracheal tube with a specifically designed device results in lower amount of     secretions at extubation, assessed by micro CT scan   "
104975|NCT01912066|"     This is a phase IV clinical study to evaluate the preventive effectiveness of     NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind,     active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug     of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for     four weeks.   "
104976|NCT01912053|"     The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration     of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous     chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic     cholangiocarcinoma.   "
104977|NCT01912040|"     Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice     to help in patient management decisions.   "
104978|NCT01912027|"     The open Latarjet techniques has benn considered as an effective treatment on anterior     shoulder instability.Over the past decade there has been a shift from open to     all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less     postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic     Latarjet techniques would have better clinical and radiographic outcomes than the open     Latarjet Techniques on anterior shoulder instability.   "
104979|NCT01912014|"     The purpose of this feasibility study is to develop and initially test a dialogue-based     psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an     acute stroke. The intervention is carried out by primary care registered nurses or other     appropriate health professionals. The intervention included persons with and without aphasia.   "
104980|NCT01912001|"     Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home     hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to     conventional in-center hemodialysis. Patients with end stage renal disease, that is failure     of the kidneys such that dialysis is required, are at high risk for adverse health events     especially during a period of transition following a change in care settings. The     investigators aim to implement a Home Dialysis Virtual Ward (HDVW) strategy of telephone     follow-up, which is targeted to minimize gaps of care during transitions in care.      The investigators aim to have clinicians follow patients by telephone if they meet one of the     following four criteria;        1. Discharge from hospital.        2. Having an interventional procedure.        3. Prescription of an antibiotic.        4. Completion of Home Dialysis training.      The major goal of this HDVW initiative is to provide appropriate and effective supports to     medically complex patients in a targeted window of vulnerability.   "
104981|NCT01911988|"     The purpose of this study is to determine association between Peripheral Immune Cells(PIC)     and recurrence in stage II/III colorectal cancer   "
104982|NCT01911975|"     Lacosamide is a functionalized amino acid with antinociceptive properties in inflammatory and     neuropathic pain, and displays a unique mechanism: it enhances slow inactivation of Nav1.3,     Nav1.7, and Nav1.8.      Nav1.7 is expressed predominantly in nociceptive and sympathetic neurons. Gain-of-function     mutations have been described in Nav1.7 that result in extreme pain disorders such as     SCN9A-associated small fiber neuropathy. In the disease states genetically linked to a     gain-of-function of Nav1.7, the sodium channel is mutated to increase the sodium influx     resulting in a hyperexcitable sensory neuron, and a resultant sensation of pain.      The objective of the study is to determine the efficacy and safety of lacosamide, a sodium     channel blocker, in patients with pain due to SCN9A-associated small fiber neuropathy.   "
104983|NCT01911962|"     To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice     surgery VS transabdominal surgery.   "
104984|NCT01911949|"     Hip replacement surgery is one of the most common elective surgeries in Canada and with this     surgery, there is considerable pain after the operation. By decreasing the amount of pain     after surgery, the patients may be able to move and walk quicker, resulting in easier     physiotherapy sessions, shorter hospital stays and may help to avoid adverse outcomes like     nausea and vomiting and being overly sedated. By using ultrasound guided femoral nerve block,     it may be an alternative for pain management with minimal side effects for patients having     hip replacement surgery.   "
104985|NCT01911936|"     This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.   "
104986|NCT01911923|"     Atelectasis is common during and after general anesthesia. The investigators hypothesized     that a ventilation strategy with a combination of 1) continuous positive airway pressure     (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen     fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce     the area of postoperative atelectasis.   "
104987|NCT01911910|"     Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common     and can lead to severe disability or death. Changes in the body leading to heart attacks and     strokes usually develop over decades as a result of smoking, diet, and lack of exercise,     obesity, diabetes and high blood pressure. Changes in lifestyle and diet can significantly     reduce the risk of heart diseases. General Practitioners invite 40 to 74 year-olds who have     no known heart disease to take part in the NHS Health Check, which measures each person's     individual risk of developing a heart attack or stroke and encourages them in a face-to-face     meeting to take part in programmes to help them to give up smoking, lose weight etc. where     necessary. In this new clinical trial the investigators will test whether computer-tailored     electronic (e)-coaching via email and the internet can help people make the necessary changes     in their lifestyle to reduce the risk of heart attacks and strokes.   "
104988|NCT01911897|"     To evaluate the safety and performance of the MobiusHD system in subjects with resistant     hypertension.   "
104989|NCT01911884|"     The principal objective is to assess the general health status and the sexual health status     of women with Rokitansky syndrome having received a surgical or non surgical treatment.      The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To     search a correlation between the anatomical result, the general and sexual quality of life.     To compare the different techniques of medical follow-up in terms of anatomic results,     general quality of life, sexual quality of life, complications and morbidities.      To evaluate social inclusion of these women with their family situation, social and     professional category and their job.      At the same time, we propose an evaluation with a psychologist to study the impact of the     announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.   "
104991|NCT01911858|"     The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on     III degree burns by quantifying the concentration of silver in the blood during treatment and     thus to show that the amount of silver absorbed will be no greater than those reported in the     literature.   "
104992|NCT01911845|"     The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267     (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and     ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus     (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.   "
104993|NCT01911832|"     The incidence of cancer of the esophagogastric junction has rapidly risen in recent three     decades, and surgery still remains the optimum therapy. For Siewert's type II and III cancer,     esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal     gastrectomy are regarded as the two main surgical approaches. Esophagojejunostomy after total     gastrectomy brings high survival rate and low local recurrence rate which may also induces     pulmonary infection or regurgitation. Roux-en-Y gastrojejunostomy after subtotal gastrectomy     needs reconstruction of the gastric tube and the width of reconstruction tube was a key     factor to predicate prognosis. However, no evidence supplies a comprehensive standard on the     width of reconstruction tube which often ranges from 3 cm to 6 cm. Both narrow and wide     reconstruction tubes have their own advantages and disadvantages. So the prospective trail     recruits patients into three groups: total gastrostomy group (TG group), wide gastric tube     group (WG group) and narrow gastric tube group (NG group). And the investigators compare the     quality of life using integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom     relief as main endpoints.   "
104994|NCT01911819|"     The purpose of this study is to compare new bone formation following bone graft in sinus     using three different commercially available bone graft materials. The study hypothesis is     that there is no difference in new bone formation among three bone graft materials under     microscope.   "
104995|NCT01911806|"     This study aim to investigate the effects of back care pillow, in adjective with standard     physical therapy treatment for chronic non-specific low back pain.   "
104996|NCT01911793|"     Postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients.     Stomas are frequently created in conjunction with major colorectal surgery. Obstruction at     the level of the stoma is a common cause of bowel obstruction or ileus. This is often     manifested by decrease or delay in stoma output and is often attributed to edema at the level     of the stoma. Thus, a temporary tube (red robinson catheter) is placed into the stoma at     bedside, which often relieves the obstruction until the edema at the level of the stoma     resolves and stoma function occurs around the temporary tube. At this time, the tube is     removed and the stoma continues to function normally.      The purpose of this study is to evaluate whether a stoma tube (red-robinson catheter) placed     at the time of stoma creation would reduce the incidence of postoperative ileus in patients     undergoing major colorectal surgery with creation of a stoma.   "
104997|NCT01911780|"     This is a multi-centre, randomised, double-blind, active-controlled, parallel-group     comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +     hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+     hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the     end of the double-blind period in essential hypertensive patients who fail to respond     adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.      Patients are assigned to one of the two groups after a 6-week open-label run-in period taking     T80/H12.5 mg.      In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide     12.5 mg will be evaluated in a 52-week extension period.      In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg     group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5     mg group change to the T80/A5/H12.5 mg therapy.   "
104998|NCT01911767|"     The primary objective of the study is to prospectively evaluate pregnancy outcomes in women     with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis     product during the eligibility window for that product. The Registry-specified Biogen MS     products being studied are dimethyl fumarate, Pegylated human interferon beta-1a, and     Dalclizumab High Yield Process (DAC HYP).   "
104999|NCT01911754|"     The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic     influenza vaccine in a Japanese pediatric population aged 6 months to 17 years   "
105000|NCT01911741|"     A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide)     formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the     safety and tolerability of oral formulations.      Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up     to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last     pharmacokinetic (PK) sampling or after early withdrawal.   "
105001|NCT01911728|"     A drug-drug interaction study to investigate the potential pharmacokinetic interaction     between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin     (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate).   "
105002|NCT01911715|"     A study to investigate the excretion routes of radio-labelled MDV3100.   "
105014|NCT01911559|"     Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced     mobility and consequent constipation. Clinicians frequently recommend standing-frames to     exercise the support reaction in this population, sharing the opinion that the upright     position may facilitate intestinal transit, although no evidence supports this assumption.      The investigators conducted this single-subject research to determine the effects of the     standing-frame on the frequency of evacuation in chronically constipated children with CP and     quadriplegia.      Moreover, the investigators studied its effects on the frequency of induction of evacuation,     the characteristics of the stool and the pain suffered by the child due to constipation     and/or evacuation.   "
131696|NCT01561209|"     The objective of this prospective randomized and controlled study is to evaluate the efficacy     and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.   "
105231|NCT01908712|"     The overall objective of this trial is to provide aftercare treatment with Lamazym and to     evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis     whom previously participated in Lamazym-trial.   "
105003|NCT01911702|"     Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to     intra-abdominal generalized infection. With the exception of the primary ones which are the     result of a bacterial translocation from the gastro-intestinal tract or an abdominal     contamination for hematogenous way sometimes treatable with medical therapy alone,     peritonitis represents a complex condition that requires an early surgical treatment.      Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when     associated with a systemic framework of severe sepsis. This variability is linked to a number     of risk factors, including advanced age of the patients, the presence of comorbidity, male     sex, a poor nutritional status, and a number of re-operations; as well as specific     characteristics related to the type of infection, the timing of surgery, the beginning of an     appropriate and early antibiotic therapy.The post-operative treatment of the patient with     peritonitis significantly affects the outcome of the same. The presence of peritonitis and     then the seizure of large volumes of liquids and the possible state of systemic vasodilation     induced by the infectious process, provide a framework of hypovolemia. There is a literature     that identifies in abdominal trauma damage patient's volemic aggressive resuscitation an     element of pejorative outcomes. The purpose of this work is to evaluate the clinical changes     determined by a different volemic strategy.   "
105004|NCT01911689|"     To quantitatively analyze the T2* values of the head, body, and tail of normal pancreas, and     observe the value of GRE T2*-weighted MRI in the diagnosis of acute pancreatitis and the     relationship between the T2* value and the severity of AP.   "
105005|NCT01911676|"     This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of     stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this     study is to test the efficacy of treatment with one of two does of a glycine transporter     inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function.     Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I)     and placebo twice daily in addition to their antipsychotic medication for 2 treatment     periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout     period lasting approximately 3 weeks.   "
105006|NCT01911663|"     This study is a randomized, double-blind, placebo-controlled clinical trial designed to     evaluate the effect of Korean red ginseng supplementation on glucose control in subjects with     impaired fasting glucose, impaired glucose tolerance or newly-diagnosed type 2 Diabetes     Mellitus and to establish a clinical evidence on glucose control effect of KRG.   "
105007|NCT01911650|"     The overall goal of this proposal is to correlate ultrasound elastography technique with more     standard clinically based outcome measures within the setting of a small sample sized group     of patients affected by moderate-to- severe, chronic (>6months) midsubstance Achilles     tendinopathy (AT).   "
105008|NCT01911637|"     VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and     tolerable single dose of VBY-036 in healthy volunteers. Volunteers are randomly selected to     receive one dose of either a placebo or VBY-036 (10, 30, 100, 300, 600 or 900 mg).   "
105009|NCT01911624|"     Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with     staphylococcus aureus bacteraemia.      The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct     thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus     bacteremia.   "
105010|NCT01911611|"     This randomized, double-blind, placebo-controlled study will evaluate the safety,     tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be     randomized to receive single ascending doses of either RO6870868 or placebo, with or without     food.   "
105011|NCT01911598|"     This open-label, multicenter study will evaluate the safety, tolerability, and     pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or     carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There are     two stages for each arm in this study: a Dose-limiting Toxicity (DLT)-evaluation stage (Stage     I) and a cohort-expansion stage (Stage II). In Stage I, DLTs will be assessed during a DLT     Assessment Window of 21 days (i.e., Cycle 1 Day 1 through Cycle 1 Day 21) for both arms. In     Stage II, participants will be enrolled to further characterize the safety, pharmacokinetics,     and anti-tumor activity of MEHD7945A in combination with cisplatin + 5-FU or carboplatin +     paclitaxel at the identified recommended Phase II dose.   "
105012|NCT01911585|"     The purpose of this study is to determine whether 60-minute sessions of prolonged exposure     (PE) are as effective as the standard 90-minute session for treating posttraumatic stress     disorder (PTSD). Participants will include patients ages 18 or older with a current diagnosis     of PTSD who are seeking treatment in our clinic. Patients who have current substance     dependence, psychosis, and suicidal ideation with intent and plan may not be suitable for     receiving PE and may be offered another treatment or referred to a different treatment     center. Participants will be randomized to receive either the 90- minute or 60-minute PE     session. A blind evaluator will assess for pre-treatment, post-treatment, and follow-up     levels of symptom severity using the PTSD Symptoms Scale Interview (PSS-I). Participants will     attend weekly treatment sessions with any of our faculty members and will complete     self-report measures at every session (see below).   "
105013|NCT01911572|"     Invasive bacterial infection is a dangerous but relatively uncommon disease where bacteria     spread deep into the body causing diseases like blood poisoning ('bacteraemia'), pneumonia,     meningitis and others. The various bacteria of the streptococcus family are an important     cause, often leading patients to require intensive care despite which, for some strains, one     in five patients die. One notable form is called necrotising fasciitis, a condition where     bacteria rapidly spreads through and destroys the layers of tissue just under the skin.      As individuals vary greatly in their risk of developing such serious infections,     investigating how the genome, the inherited blueprint of our bodies, of these patients     differs from that of healthy volunteers can help to explain why the disease develops in some     and not others. For some streptococcal bacteria such as Streptococcus pneumoniae this     approach is already proving successful; for others such as the Group A strain     (Streptococcus pyogenes) it has yet to be explored but carries excellent potential.      The investigators have secured the support of the Lee Spark Necrotising Fasciitis Foundation     to recruit from their membership survivors of streptococcal infections and some of their     family members. The investigators will also ask infection specialists from NHS hospitals to     invite patients they have looked after. The investigators also have a small existing     collection. Taking part would involve registering information on a website, discussing the     study on the telephone and then providing us with a sample of saliva from which the     investigators can isolate DNA. The investigators would prepare the sample for analysis of the     genome and compare the patients with both their family and an existing reference collection     from healthy volunteers using technology that reads the DNA code.      Our study will be a first key step in renewing efforts to understand the determinants of     invasive streptococcal infection, which is important for developing better treatments and     vaccines.   "
105015|NCT01911546|"     A growing number of patients on the kidney transplant waiting list are broadly human     leukocyte antigen (HLA) sensitized (HS). These patients are unlikely to have a compatible     donor. Therefore they wait longer and have increased morbidity and mortality. Desensitization     with intravenous immune globulin (IVIG) and rituximab with alemtuzumab induction improves     transplant rates and achieves good allograft outcomes. However, HS patients are at risk for     viral infections after transplant. We have previously shown an increased incidence of BKV     infections after desensitization with HS patients having higher peak viral loads.     Cytomegalovirus (CMV) and polyomavirus BK (BKV) infections place HS renal transplant     recipients at particular risk. Allograft rejection is associated with both CMV and BKV     infection. This is of particular concern for HS patients as they are at an increased risk of     rejection at baseline. Furthermore, the frequent development of leukopenia after     transplantation often requires the CMV prophylactic agent to be discontinued along with     lowering immunosuppression. This increases the risk of CMV infection and allograft rejection.      Everolimus was approved for rejection prophylaxis in combination with calcineurin inhibitors     (CNI). CNI used in the study that led to drug's approval was cyclosporine. There are several     trials nearing it's completion that utilize low dose tacrolimus instead. In 2012 Novartis     published data from several trials showing superior outcomes using everolimus + low dose     tacrolimus. This combination is currently approved in EU. It is also a combination that is     standard of care (SOC) at our center for patients on everolimus.      This study aims to demonstrate that use of everolimus as part of a maintenance     immunosuppression regimen may decrease viral infections without lowering overall     immunosuppression thus improving allograft function and survival.   "
105016|NCT01911533|"     Hypothesis:      Extracorporeal removal of CO2 can treat hypercapnia and respiratory acidosis, which allows     application of lung protective ventilation. This downgrading of mechanical ventilation     promotes better and more quickly lung recovery.      Aim:      The aim of the study is to treat respiratory acidosis and to reduce plateau pressures by     using an extracorporeal removal of CO2 (ECCO2-R).      This prospective study will include 10 patients with an Acute Respiratory Distress Syndrome     (ARDS). ARDS is an inflammatory response in the lungs, the onset is acute with pulmonary     oedema and shows bilateral densities on chest radiography. The take up of oxygen and the loss     of CO2 in the lungs are difficult. Moreover the patient's blood can become acidic due to too     much CO2.      To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This     can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover,     CO2 can be removed so that the mechanical ventilation setting will be less aggressive and     will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood     from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood     and extracts carbon dioxide from the blood) and back into a vein.      The investigators will use a standard dialysis catheter that will be put in a large vein. To     prevent clotting of the system, the patient will receive heparin.      In the study the investigators will work in periods of two hours, the situation before and     after carbon dioxide removal will be compared. With this study the investigators want to     prove that the CO2 in the blood decreases with at least 20 % with the use of the     extracorporeal CO2 remover. More over the investigators want to prove that lower mechanical     ventilation settings (thanks to CO2-removal by the ECCO2-R) will produce fewer lesions to the     lungs.   "
105017|NCT01911520|"     During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain     good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission     blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is     still some neuromuscular blocking activity left in the patient on awakening from anesthesia.     This is called residual curarization and is known to cause postoperative complications such     as impairment of respiratory function.      Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It     allows for reversing of neuromuscular transmission blocking activity. Until now, all studies     with sugammadex were performed in non-obese patients.      Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore     it is vital to avoid residual curarization. Sugammadex might be an important factor.      Obese patients have a large total body weight different from ideal body weight. Recent     research demonstrated that the dose for the neuromuscular blocking agent rocuronium     (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total     Body Weight.      At this moment no data is available on the dose-response relationship of sugammadex in     morbidly obese patients.      We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal     bodyweight, instead of total bodyweight.   "
105018|NCT01911507|"     This phase I trial studies the side effects and best dose of c-Met inhibitor INCB028060 and     erlotinib hydrochloride when given together in treating patients with previously treated     non-small cell lung cancer. C-Met inhibitor INCB028060 and erlotinib hydrochloride may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
105019|NCT01911494|"     This project is being undertaken to test the hypothesis that implementing a community based     package of care for women with hypertensive disorders of pregnancy will result in overall     improvement in maternal and neonatal outcomes. This is based on the premise that there are     three main modifiable reasons why women (and their fetuses/newborns) die due to pregnancy     complications: 1) delays by the woman herself in recognizing the seriousness of her     condition; 2) delays in her being assessed and then transported to a center capable of     providing effective and life-saving interventions; and 3) delays in the health facility in     providing those interventions. The treatments for pre-eclampsia that are poorly accessed in     LMIC are 1) magnesium sulfate (MgSO4) for prevention and treatment of the grand mal seizures     of eclampsia; 2) oral antihypertensive medication to lower maternal BP to reduce the risk of     stroke.      The CLIP pilot and definitive cRCT will investigate whether the community level intervention     including implementation of the CLIP package (oral antihypertensive therapy when indicated,     intramuscular (i.m.) MgSO4 when indicated; and appropriate referral to an CEmOC facility when     indicated) of care will reduce the incidence of all-cause maternal morbidity and mortality.   "
105020|NCT01911481|"     The investigators are carrying out a study of 164 pregnant women, with breech presentation at     term who will undergo to external cephalic version. The investigators' goal is to know if     oral maternal hydration can increase the successful of external cephalic version   "
105021|NCT01911468|"     The purpose of this study was to determine whether combined treatment with liraglutide and     metformin is more effective than liraglutide or metformin as monotherapy in the treatment of     obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders     regarding weight reduction on metformin monotherapy. We anticipated greater changes in body     weight in patients on combined treatment than in those on monotherapy with liraglutide or     metformin.   "
105022|NCT01911455|"     In this research study we want to understand the effectiveness of a drug treatment,     acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment)     associated with Fragile X Syndrome (FXS).   "
105023|NCT01911442|"     This is a randomized, double-blind, placebo-controlled study designed to evaluate the     efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks     compared with placebo in pediatric and adolescent subjects with irritability associated with     autistic disorder who reside in the community setting.   "
105024|NCT01911429|"     Efficacy and Safety study of Lurasidone in pediatric patients.   "
131859|NCT01559077|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.   "
105025|NCT01911416|"     Pancreatic cancer is considered a rare form of cancer with about 277,000 new cases diagnosed     in 2008 world-wide, which is about 2.5% of all forms of cancer. However, pancreatic cancer is     more common in developed countries where the rate of this tumor is on the rise compared to     other types of cancer.      LDE225 is a new medicine that blocks a cellular pathway (called Hedgehog pathway) that is     thought to be changed in some patients with pancreatic cancer. LDE225 is a medicine which has     not been approved by the FDA for the treatment of people with your medical condition. The     medicine being tested in this study is currently not on the market (available to buy) in     any country.      The purpose of this study is to see the effect LDE225 has on blood and tumors.   "
105026|NCT01911403|"     Clinical study in patients undergoing any intervention requiring vascular access to the     femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control     the vascular access.      It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.   "
105027|NCT01911390|"     A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility study     to evaluate whether dietary intake of dry bean powder or rice bran or a combination is a     helpful dietary recommendation to reduce total cholesterol levels in children with     identified, modifiable CVD risk factors, elevated total cholesterol and obesity. Consumption     of dry bean powder and rice bran merit additional investigation to study feasibility and     acceptability in children and how they influence their lipid levels or obesity.   "
105028|NCT01911377|"     This study will examine the efficacy of Botulinum Toxin Type A (Botox) in treating     Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis.      Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system,     and is common in spinal cord injury patients or people with multiple sclerosis.      Allodynia is a type of neuropathic pain caused by something that normally would not cause     pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.      Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord     injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has     recently been studied as a treatment for neuropathic pain.      We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type     neuropathic pain.      24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 controls     receiving placebo.   "
105029|NCT01911364|"     The purpose of this study is to determine the triple combination of beclometasone     dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of     severe COPD patients (chronic obstructive pulmonary disease)   "
105030|NCT01911351|"     Title:      High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety     during pediatric minor procedures.      Objective: To assess whether the use of high-concentration continuous flow nitrous oxide in     addition to standard management increases the comfort level in pediatric patients undergoing     minor procedures compared to standard management alone.   "
105031|NCT01911338|"     -  Background Context: no studies have been identified to analyse the effect of real time          feedback (using inertial sensors) on physiotherapy students learning the art of          posterior-anterior thoracic manipulation (PATM).        -  Purpose: to study the effect caused by real-time feedback on the learning process for          PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant          differences will exist in the execution parameters of manipulation among students          receiving real-time feedback versus those who do not.        -  Study Design/Setting: longitudinal, pre-post intervention.        -  Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly          into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30)          (group with real-time feedback).        -  Outcome Measures: time, displacement and velocity and improvement (only between groups)          to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.        -  Methods: two groups of physiotherapy students learned PATM, one using a traditional          method and the other using real-time feedback (inertial sensor). Measures were obtained          pre- and post-intervention. Intragroup pre- and post-intervention and intergroup          post-intervention scores were calculated. An analysis of the measures' stability was          developed through an ICC (1,2).        -  Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant          differences were found in all variables analysed (intra- and inter-group) in favour of          G2.        -  Conclusions: the learning process for posterior-anterior thoracic manipulation is          facilitated when the student receives real-time feedback.   "
105032|NCT01911325|"     This is a multi-center, open-label Phase Ib dose escalation part followed by a randomized     double-blinded placebo controlled Phase II part.      The Phase Ib part will determine the Maximum Tolerated Dose (MTD)/Recommended Phase II Dose     (RP2D) of buparlisib in combination with docetaxel. Subsequently the MTD/RP2D will be     investigated in a Phase II randomized trial in patients with advanced or metastatic squamous     NSCLC.   "
105033|NCT01911312|"     An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body     temperature muscle stimulation for eliciting muscle contraction in the quadriceps   "
105034|NCT01911299|"     The purpose of this study is to determine whether choline supplementation can improve     cognitive functioning of children with prenatal alcohol exposure.   "
105035|NCT01911286|"     Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem     reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous     breathing is established the apnea test (according to the American Academy of Neurology's     Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and     cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some     data suggest modifying the apnea test : replace the ventilator switching off with continuous     positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP)     increased the level of lung harvest but they were not sufficient because these studies were     monocentric with little patients,. That why the aim of the present study is to compare the     standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each     center will use the method of apnea test which it uses usually.   "
105069|NCT01910844|"     Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients     with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and     Taxanes.   "
105036|NCT01911273|"     The primary purpose of the study is to explore whether treatment with PF-03446962 and best     supportive care is better than placebo plus best supportive care in prolonging survival of     patients affected by recurrent liver cancer. In addition, the study will explore if adding     PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are     patients' characteristics (biomarkers) that may predict response to PF-03446962, and if     PF-03446962 has any effect on the patients' quality of life.   "
105037|NCT01911260|"     The purpose of this study is to measure the effect of weekly zinc supplementation on     schoolchildren with growth deficit or normal stature.   "
105038|NCT01911247|"     The overall goal of this proposal is to investigate the potential benefit of metformin as a     novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect     of short-term metformin treatment on the endometrium of obese women with endometrial cancer     by comparing each patient's endometrial biopsy before treatment with metformin to their     post-treatment hysterectomy specimen.      Participants: Obese women who are to undergo surgical staging for endometrial cancer will     also receive short-term treatment (1-4 weeks) with metformin that will continue until the day     prior to surgical staging.      The effect of metformin on proliferation, apoptosis and downstream signaling pathways will be     compared between pre-treatment endometrial biopsies and post-treatment hysterectomy     specimens. Tissue microarrays will be constructed and immunohistochemstry performed to     evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by     metformin, and these findings will be correlated with our in vitro preclinical studies. Fresh     tissue will also be obtained, and Western immunoblotting will be used to assess expression of     the phosphorylated forms of the downstream targets of metformin. The hypothesis is that     treatment with metformin will result in a decrease in proliferative markers and an increase     in markers of apoptosis in the endometrial cancer tumors. AMPK phosphorylation and inhibition     of critical downstream targets of the mTOR pathway will be seen in the post-treatment     hysterectomy specimens. Metabolomic profiling will also be performed of tumors and associated     biofluids (i.e. serum and urine) before and after treatment with metformin to identify     potential biomarkers of response to this therapy.   "
105039|NCT01911234|"     The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II     clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of     clinical efficacy are promising.      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in     subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working     anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be     enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K     will also be evaluated.   "
105040|NCT01911221|"     The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult     population potentially at risk for meningococcal disease (e.g. lab workers).   "
105041|NCT01911208|"     The purpose of this study is to test a recruitment intervention to increase racial and ethnic     diversity in clinical trials. The trial will be conducted in specialty care clinics. In     RECRUIT minorities are those underrepresented in clinical trials and include:        -  African Americans/ Blacks        -  Asians        -  Native Hawaiians/Other Pacific Islanders        -  Hispanic/Latinos        -  Native Americans/Alaskan Natives   "
105042|NCT01911195|"     Currently it is unknown how the human brain reorganizes its network organization to generate     conscious experience and cognitive activity after a period of unconsciousness. Therefore, the     purpose of this study is to assess how cognitive activity is reconstructed after general     anesthesia. The investigators hypothesize that the brain's transition from unconsciousness to     consciousness and full cognition is a complex process that occurs over an extended period of     time. Specifically, the investigators hypothesize the following order of cognitive     reconstitution: responsiveness to command, attention, complex scanning and visual tracking,     working memory, and executive function.      Volunteers will be healthy participants who are anesthetized with commonly used anesthetic     drugs as well as a non-anesthetized group to control for circadian influences. A total of 60     subjects will be recruited for this study. All subjects (male and female) will perform basic     tests for cognition on a laptop computer at 30-minute intervals during this study. The     testing battery to be administered was assembled to assess multiple cognitive functions in     order to determine whether and how cognitive processes return to baseline function.     Electroencephalogram (measuring brain electrical activity) data will be monitored and     recorded during both anesthesia and cognitive testing, for subsequent analysis.      This study is significant because it could lead to a better understanding of the neural     correlates of human consciousness, as well as normal and abnormal conscious state transitions     (including barriers to such transitions).   "
105043|NCT01911182|"     In premature infants, apnea of prematurity is one of their major clinical problems. Caffeine     is currently a worldwide therapy to reduce the number and severity of these apneas. This     practice has shown to be safe on cognitive and neurodevelopmental outcomes at 18 to 21 months     of age. However, caffeine is not 100% effective, and may have little effect on hypoxemia and     bradycardia. Infants with intractable apneas unresponsive to caffeine treatment may require     endotracheal intubation and mechanical ventilation. This procedure is invasive and has been     associated with complications and increased risk for chronic lung disease and adverse     neurodevelopmental outcome. Therefore, an alternative treatment modality would be preferable     if it would prevent the infants from requiring endotracheal intubation. The investigators     have been testing the overall hypothesis that small concentrations of inhaled CO2 (~1%) are     effective in treating apnea of prematurity. The investigators have completed three studies in     preterm infants showing that inhalation of low concentration of CO2, in infants not on     caffeine, regularize breathing and decrease apneas significantly. The effects of inhalation     of CO2 in infants already on caffeine, are unknown. The hypothesis to be tested is that     inhalation of low concentration CO2 (1%) will significantly reduce apnea in infants treated     with caffeine. The investigators have three specific aims in this proposal. 1) the     investigators want to know if the apnea rate (number of apneas of ≥5 seconds/hour) is     decreased with CO2 inhalation in preterm infants already on caffeine for the treatment of     apnea of prematurity; 2) the investigators want to know whether inhalation of CO2 can make     breathing more regular with less apneic time and whether it decreases prolonged apneas (>20     seconds) in infants already on caffeine for the treatment of apnea of prematurity; 3) the     investigators want to assess the effect of inhalation of low concentration of CO2 on the     regional oxygen saturation of the brain measured by near-infrared spectroscopy (NIRS) during     apneas. This is to see whether CO2, by protecting cerebral blood flow, minimizes the decrease     in cerebral oxygenation during apneas. This study entails a new and possibly more     physiological method of treating apneas of prematurity that can be added to the present     treatment of caffeine. These two treatments together, could minimize the number and severity     of apneas and possibly decrease the need for mechanical ventilation in preterm infants.   "
105070|NCT01910831|"     To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in     improving the appearance of bruising and reducing the appearance of photoaging of the     forearms and hands in mature skin. Assessments will be made through ongoing objective     measurements and clinical ratings.      To confirm the safety (local tolerance) of DerMend Moisturizing Bruise Formula.   "
105044|NCT01911169|"     Determine the effect of vitamin D repletion on flow mediated dilation (FMD, a measure of     endothelial function) in vitamin D deficient systemic lupus erythematosus (SLE) patients. The     investigators will enroll vitamin D deficient SLE patients and randomize them to receive     either 400 IU or 5,000 IU of cholecalciferol (D3) daily and measure change in FMD as a     measure of EC function at baseline and after 16 weeks of repletion.      Determine mechanisms by which vitamin D repletion may improve endothelial function in vitamin     D deficient SLE patients and in vitro.      Determine effect of oral D3 repletion on the Type I interferon signature in WISH and ECs     cultured with pre and post plasma from D3 treated lupus patients.      Determine effect of D3 repletion on the number of circulating apoptotic and non-apoptotic EC     and EPC ex vivo.      Determine effect of exogenous 1,25(OH)D on IFN gene signature in WISH and ECs stimulated by     pretreatment SLE plasma in vitro.      Determine the effects of exogenous 1,25(OH)D on the phenotype of ECs cultured with     pretreatment lupus plasma.      This study is designed to efficiently test our hypothesis and begin to define     interferon-dependent pathways through which vitamin D repletion can restore clinical and in     vitro endothelial function.   "
105045|NCT01911156|"     This is a prospective randomized, open-label, phase IV clinical trial to learn the effects,     good and/or bad, of discontinuing or continuing nucleos(t)ide analogue (NA) treatment for 72     weeks in participants with chronic hepatitis B infection whose immune system is controlling     the amount of virus levels in the blood for at least 12 months of NA therapy.      About 66 adult men and women will participate in this study from University Health Network     which includes the Toronto Western Hospital for about 72 weeks.   "
105046|NCT01911143|"     This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic     (IVD) assay that will include samples that were previously collected from febrile pediatric     patients. The investigated assay measures the levels of a few host-related, blood-based,     bio-markers that will be integrated into a single score. Based on this score, each patient     will be classified into one of three categories: (i) bacterial immune response, (ii) viral     immune response, and (iii) marginal immune response. The assay prediction and the patient     diagnosis will than be unveiled and compared to determine their level of concordance.   "
105047|NCT01911130|"     A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was     developed to precisely and conveniently measure static limb strength in patients with ALS.     The investigators will compare ATLIS data with data from two commonly used ALS outcomes     measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in     a prospective, longitudinal study. All three outcomes measures will be performed on 100     subjects collected preferably at bi-monthly clinic visits during the study period.   "
105048|NCT01911117|"     In one previous study, esCCO was compared with continuous thermodilution CO (TDCO),     measurements in 36 postoperative cardiac surgery patients, showing a bias (mean difference)     of -0.06 and a precision (1 SD) of 0.82 L/min. In addition, esCCO was compared with     intermittent bolus TDCO, showing a correlation coefficient of 0.82 (P < 0.001, n = 24), a     bias of -0.63, and a precision of 1.01 L/min (n = 119). The results of clinical use of esCCO     suggest that its measurement accuracy is comparable to the thermodilution method in general     population. However, no any intraoperative comparison for cardiac surgery patients was     reported before. This study is designed for the accuracy in the patients undergoing cardiac     surgery.      Specific aims:        1. To investigate the correlation of esCCO and the traditional CO measurement in cardiac          surgical patients.        2. To investigate the intraoperative t accuracy of time point between ecCCO and traditional          CO measurement for patients undergoing bypass cardiac surgery.   "
105049|NCT01911104|"     The purpose of this study is to collect data to help researchers identify factors that     prevent certain individuals from receiving the beneficial effects of exercise.   "
105050|NCT01911091|"     The purpose of this study is to collect data to help researchers identify factors, such as     certain proteins or genetic codes, that are secreted from muscle that are associated with the     beneficial effects of exercise.   "
105051|NCT01911078|"     The purpose of this clinical investigation is to determine the effects of renal sympathetic     denervation on insulin resistance and muscle sympathetic nerve activity in patients with     metabolic syndrome.   "
105052|NCT01911065|"     In this study the investigators are trying to identify immune signatures that are associated     with effective or poor vaccine responses to naturally-acquired herpes zoster virus and the     zoster (shingles) vaccine, Zostavax.   "
105053|NCT01911052|"     Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates     of missing important lesions, increased patient discomfort, higher risk of complications,     prolonged procedure time and increased health-care cost. Recent study reported that     Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the     quality of bowel preparation and polyp detection rate. However, there is no study to compare     the effect of telephone with short message system (SMS) based re-education on the quality of     bowel preparation in health screened population. Our goal is to improve the quality of bowel     preparation with telephone or SMS based re-education for outpatients undergoing screening     colonoscopies. The investigators hypothesise that efforts to improve education and maximise     patient compliance during the preparatory period will enhance the efficacy of bowel     preparation.   "
105054|NCT01911039|"     Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or     hematopoietic cell transplant from another person (allogeneic transplant). This study will     determine if subjects with steroid dependent/refractory cGVHD can tolerate infusion of donor     regulatory T cells and whether their cGVHD responds to the infusion.   "
105091|NCT01910558|"     Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a     cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to     selectively reduce saturated fat and calories which will have a medically beneficial effect     on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α-     cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal     fat on a high saturated fat diet compared to the same diet supplemented with a digestible     carbohydrate control   "
105227|NCT01908764|"     The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension     following two posologies of bilateral ototopical doses in pediatric subjects immediately     after bilateral tympanostomy tube surgery.   "
105055|NCT01911026|"     Effective bowel preparation is important for examination of the entire colon adequately and     for identifying colonic lesions during colonoscopy. However, it is well known that bowel     preparation of inpatients is much poorer than that of outpatients. Our goal is to improve     bowel preparations with reinforcement of nurse education that explains the steps required for     bowel preparation for inpatients undergoing colonoscopies. The education will focus on     explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the     pre-colonoscopy diet, and the instructions for completing the laxative. Patients in the     control group will receive the standard written bowel preparation instructions, while     patients in the intervention group will receive standard written instructions plus a     explanation from reinforcement-educated nurse. The investigators hypothesize that patients     received a explanation from reinforcement-educated nurses will lead to improved patient     compliance and a better bowel preparation. In addition, the investigators hypothesize that a     better quality bowel preparation will improve detection of colonic polyps and patients'     satisfaction for colonoscopy.   "
105056|NCT01911013|"     The purpose of this study is firstly to determine the efficacy of cervical plate for anterior     cervical discectomy and fusion using cervical cage, and secondly to investigate the     determining factors for surgical outcomes.   "
105057|NCT01911000|"     The presence of portal vein tumor thrombosis (PVTT)in patients with HCC is one of the most     significant prognostic factors for poor prognosis, without treatment, their survival is less     than 3 months. In the HCC patients who combined with PVTT, RT showed 50% of local control and     about 10 months survival duration. Despite the standard treatment of the HCC combined with     PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an option in     those patients. Investigators previously reported the retrospective study that the scheduled     interval TACE followed by RT for HCC combined with PVTT and 60% of the patients showed     objective response without significant elevation of complication. It is reported that     hyperthermia considered as the most valuable radiosensitizer in cancer treatment,     theoretically. Based on those studies, we start this prospective study to evaluate the     objective response and adverse event in the combination treatment of RT and hyperthermia     after Transarterial chemoembolization (TACE) in the unresectable HCC patients who combined     with PVTT.   "
105058|NCT01910987|"     The objective of this study is to describe the effect of optimized retreatment with     bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib,     versus standard retreatment with bortezomib in combination with dexamethasone on progression     free survival (PFS).   "
105059|NCT01910974|"     safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system     is a new water jet system which allows to perform Endoscopic submucosal dissection with a     bifunctional catheter (injection and cutting).   "
105060|NCT01910961|"     To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality,     hospitalization costs and quality of life in patients undergoing open infrarenal abdominal     aortic aneurysm (AAA) repair.   "
105061|NCT01910948|"     To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated     fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement     of nutritional status, incidence rate of related complications, and whether it can reduce the     average postoperative hospitalization days.   "
105062|NCT01910935|"     The purpose of this study is to evaluate the effectiveness of a program to increase the     physical activity of hypertensive patients using medical services and sports facilities of     the Mexican Social Security Institute. The primary hypothesis to be proven is: The     intervention will increase the proportion of hypertensive patients complying the physical     activity minimum at week to get benefits on health in 20%, compare to patients in control     group.   "
105063|NCT01910922|"     The aim of this study is to understand the formation of food preferences from an early age.   "
105064|NCT01910909|"     1. Background 1.1. Hepatocellular carcinoma (HCC) HCC is the third most common cause of     cancer death globally. It is also the second cause of cancer mortality in Korea, despite the     incidence of HCC was fifth. The most important cause of this discrepancy is connected with     the fact that the significant portion of the HCC is detected as unresectable status.      1.2. Standard treatment of the HCC At the point of HCC diagnosis, only 30% of the patients     could receive standard curative treatment, like resection, liver transplantation, and     radiofrequency ablation (RFA). Transcatheter arterial chemoembolization (TACE) has been shown     in randomized trials to improve survival compared with symptomatic therapy alone, in the     patients without macrovascular involvement, extrahepatic disease and tumor related symptoms.     However, in the recent review of TACE, TACE might be contraindicate or not recommended in the     patients who showed vascular tumor invasion, more than 10 cm size, poor portal blood flow     and/or repeated poor response.      Recently, Sorafenib, which is one of the target agents, showed survival advantage on     unresectable HCC patients in two randomized study. In those study, sorafenib improved     approximately three month overall survival increment, however, the median survival duration     was only 10.7 months in experiment group (received sorafenib), and even 6.5 months in     Asian-Pacific trial. Additionally, the possibility that sorafenib effect could be reduced in     the patients had hepatitis B virus (HBV) was suggested in the subgroup analysis.      1.3 Radiation therapy (RT) for the HCC The use of RT in HCC is increased with the radiation     technological advances. In the unresectable patients, RT showed 50 to 60% response rate with     the dose response relationship. Recently, stereotactic body radiation therapy (SBRT) showed     excellent local control and comparable survival rate in thoracic tumor. In the HCC, SBRT also     showed 75 to 100% local control rate without significant elevation of the toxicities. One     study reported that 24 to 54 Gy SBRT achieved 87% 1year local control and 17 months overall     survival. The standard treatment of unresectable HCC is sorafenib, but Korean Liver Cancer     Study Group (KLCSG) recommend RT as an option in localized unresectable HCC. Furthermore,     Radiation Therapy Oncology Group (RTOG) started randomized trial to confirm the effect of     SBRT in unresectable HCC (RTOG 1112).      Investigators previously reported the retrospective result that the higher dose SBRT achieved     2 year overall survival 87.9% and local control 85% in the patient who showed less than 5 cm     solitary HCC without portal vein involvement.      Based on those studies, we start this prospective study to evaluate the effectiveness and     adverse event of SBRT in the patients who had solitary 3 cm or less size HCC without     extrahepatic lesion and vascular involvement.   "
105065|NCT01910896|"     To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of post     dermatological surgery scars and its safety over 12 to 24 weeks.   "
105066|NCT01910883|"     This is the first time finafloxacin was administered to humans intravenously. The principal     aim of this study was to obtain safety and tolerability data when finafloxacin was     administered intravenously as single and multiple doses to healthy subjects.   "
105067|NCT01910870|"     To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.   "
105068|NCT01910857|"     -  The overall hypothesis for the project is that racial health disparities will be reduced          by improving hypertension control in African Americans.        -  This will be accomplished through the development, implementation, and evaluation of a          cost-effective hypertension control strategy based on the involvement of a community          health worker.   "
105071|NCT01910818|"     Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic     process in the skin which can lead to increased risk of malignancy, poor wound healing, pain     and limitation of movement, and permanent loss of skin appendages with     hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and     quality of life issues. Advances in laser therapy has led to the use of fractional laser     treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading     to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test     the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling     in patients affected by chronic radiation injury. Understanding and correcting this     underlying fibrotic process can help restore normal skin functions in patients affected with     chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology     such as scleroderma, morphea, or nephrogenic systemic fibrosis.   "
105072|NCT01910805|"     Women with a history of gestational diabetes (GDM) have a substantially increased risk of     developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2     diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of     developing type 2 diabetes among women with a history of GDM may be particularly important to     altering behavior changes associated with reducing risk. Certain populations have lower     perceived risk of developing type 2 diabetes, despite having a higher prevalence of the     disease. Specifically, African-Americans have a lower perceived risk of developing type 2     diabetes compared to whites, despite their more than doubled risk of developing the disease.     Improvement in awareness of diabetes risk among African-American women at high-risk of     developing type 2 diabetes, such as those with a history of GDM, could reduce future risk of     this disease among this group.      As such, we will conduct a two-armed, pilot randomized controlled trial to evaluate whether a     postpartum diabetes education intervention, incorporating nutrition, exercise, and diabetes     risk assessment can improve diabetes risk awareness, diet, and physical activity levels at     1-year post-pregnancy among African-American women with a recent history of gestational     diabetes.      We hypothesize that attendance at a 3-month and 9-month postpartum diabetes education class     will:        1. Improve diabetes awareness as measured using the Risk Perception for Developing Diabetes          among women in the intervention group compared to women in the control group when          measuring at 3-months postpartum compared to 12-months postpartum        2. Improve dietary habits and physical activity levels in the intervention group compared          to the control group when measuring at 3-months postpartum compared to 12-months          postpartum   "
105073|NCT01910792|"     Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes     including cystic fibrosis, among others, or who have undergone gastric bypass have increased     incidence of vitamin D deficiency relative to the general population. Given that vitamin D is     fat soluble and absorbed in the proximal small intestine, it has been documented that vitamin     D deficiency in people with a fat malabsorption syndrome is due to decreased absorption of     vitamin D.      The amount of vitamin D produced from winter sunlight (in Boston, MA) and dietary sources     will negligibly raise blood vitamin D levels in these patients, and oral vitamin D     supplementation may have limited efficacy due to malabsorption. A variety of UV light sources     have been developed and sold as in-home tanning devices and to produce vitamin D in reptiles.     The efficacy of correcting vitamin D deficiency by the skin exposure to an artificial source     of UVB radiation in patients with fat malabsorption syndromes (Crohn's disease, ulcerative     colitis, or cystic fibrosis) or after gastric bypass surgery has not been studied. The     investigators have conducted a pilot study in healthy adults that demonstrated that exposure     to the lamp raised the blood level of 25-hydroxyvitamin D with no side effects. The main     purpose of this study is to evaluate the effect of the FDA approved artificial source of     ultraviolet (UVB) radiation (Sperti® lamp) in improving vitamin D status in patients with fat     malabsorption syndromes and patients who have undergone roux-en-Y gastric bypass surgery.   "
105074|NCT01910779|"     Use of higher energy doses (120-150 J) may not offer additional benefits and higher success     rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial     fibrillation cardioversion. In this prospective open-label randomized trial consecutive     patients with AF and candidate to AF electrical cardioversion will be randomized to receive     100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each     group to anterolateral or postero-anteriore placement of defibrillator electrodes.   "
105075|NCT01910766|"     Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10     (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic     ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university     hospital and private practice setting. One hundred ten infertile women with PCOS resistant to     CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day     alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.      Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness,     pregnancy rate (PR) and miscarriage rate.   "
105076|NCT01910753|"     The purpose of this study is to examine the feasibility of resistance training and physical     functioning associated with nutrition therapeutic education in head and neck cancer patients,     during their treatment (chemotherapy with or without radiotherapy).   "
105077|NCT01910740|"     The main aim of this study is to investigate whether increasing the amount of physical     activity in frail older people during hospital based rehabilitation is associated with better     mobility outcomes compared to usual care. A second aim is to investigate whether this     physical activity intervention is associated with improvements in health related quality of     life. Finally we plan to investigate whether increasing the amount of physical activity     during rehabilitation is cost effective, measured from a health system perspective, compared     with usual care.      Older people receiving inpatient rehabilitation will be randomly assigned to an intervention     group, who will receive extra physical activity on weekdays and weekends or a control group,     who will receive additional activities based on social interaction. The activity sessions     will be individualized to the particular participant. Both groups of people will be assessed     at baseline, discharge from hospital and at 6 months following discharge. The intervention     group will be provided with one or two extra sessions on weekdays and two extra sessions on     weekends for the duration of their rehabilitation stay. To account for the extra     physiotherapy time that the intervention group receives, the people in the control group will     spend the same amount of time performing other activities, such as cards, board games or     reading, whilst seated. To ensure the safety of the participants in this study, each physical     activity session will be supervised by either a physiotherapist or allied health assistant.      Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the amount     of physical activity in frail older people during rehabilitation will lead to more optimal     mobility at discharge, as measured by gait speed.      Secondary hypotheses are that, compared with usual care, increasing the amount of physical     activity during rehabilitation will:      Hypothesis 2: lead to significantly greater improvements in mobility and function both at     discharge and six months following discharge.      Hypothesis 3: lead to better quality of life six months following hospital discharge,     measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale     (EQ-VAS).      Hypothesis 4: be cost effective compared to usual care   "
105078|NCT01910727|"     The objective of the Together on Diabetes study is to test the efficacy of a pilot     intervention to improve the prevention and management of type 2 diabetes among American     Indian youth.      The primary aim of this study is to determine the impact of the Together on Diabetes pilot     intervention on youth diabetes risk behaviors, including:        -  Improvement in youth dietary intake, with a specific focus on reducing the percent of          total calories from fat.        -  Improvement in youth physical activity, with a specific focus on increasing the number          of minutes of physical activity each week.      An additional primary aim of the study is to determine the feasibility and acceptability of     the pilot intervention and evaluation, including program adherence and program satisfaction.      The secondary aim of this study is to determine the feasibility of collecting data to     determine program impact on a number of physiological measures.   "
105079|NCT01910714|"     The investigators seek to adapt, implement and evaluate a randomized controlled trial of an     evidence based intervention delivered by Apache interventionists to reduce HIV/AIDS risk,     targeting Apache adolescents. Specific study objectives include:        1. To perform formative research through focus groups and individual interviews on          attitudes, practices and intervention preferences among Apache adolescents and community          stakeholders.        2. To adapt the Focus on Youth (FOY) evidence-based intervention using findings from the          formative research, components of Protection Motivation Theory, and input from a          community advisory board.        3. To enroll 304 White Mountain Apache youth ages 13-19 to participate in a randomized          intervention trial measuring behavior change at 6- and 12- months follow-up.        4. To determine the feasibility of gathering biological specimens via self-administered          swabs to track sexually transmitted diseases among 18-19 year olds enrolled in this and          future studies.   "
105080|NCT01910701|"     The aim of the proposed research is to implement and evaluate a follow-up study of the impact     of the Family Spirit family strengthening program among a high-risk sample of Apache mothers     and their children. The Family Spirit intervention is a 52-session home-visiting curriculum     administered by American Indian paraprofessionals to young mothers from 28 weeks gestation     through the child's first 3 years of life. In a series of pilot studies and a recently     completed randomized controlled trial, the Family Spirit intervention has been found to     positively impact several maternal, parenting and child outcomes up through three years     postpartum. In the proposed study, the investigators will implement the Family Spirit     intervention to young mothers (12-20 years at conception), with revisions to several     assessment measures and to the curriculum such that the substance abuse prevention curriculum     modules will be taught earlier than in the original study.   "
105081|NCT01910688|"     The present study will assess the feasibility of using endoscopic radiofrequency ablation     (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and     decreased compliance after a failed Roux-en-Y gastric bypass.   "
105082|NCT01910675|"     The purpose of the study is to find out if the regimen of prothrombin complex concentrate     (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus     fibrinogen if needed) during the early stages of the transfusion therapy in postpartum     haemorrhage (PPH). The original protocol included the use of HES and the recruitment of     patients was postponed while waiting the final decision by EMA. All HES solutions were     abandoned at our institution in September and an amendment was made to change the protocol.     HES solution are replaced by the use of hyperoncotic (20%) albumin.   "
105083|NCT01910662|"     This is an exploratory study to develop methodologies for the assessment of T-cell mediated     therapies via skin immune challenges studies in healthy volunteers. The study will     investigate what is the most appropriate; skin challenge agent, time and methodology to     sample and characterise T-cells in the delayed type hypersensitivity (DTH) skin reaction. The     skin challenge agents to be used in this study will be the neoantigen Keyhole Limpet     Hemocyanin (KLH) and recall antigen Tuberculin Purified Protein Derivative (PPD). Part A of     the study will assess an intradermal (ID) KLH challenge in three subjects to assess if the     immune response to KLH is initiated by the innate or adaptive immune system. Each subject     will receive one ID dose of 0.1 milligram (mg) KLH and will be assessed for a skin     inflammatory response. Part B of the study will assess repeat ID challenges 28 days apart;     the objective will be to characterise the T-cell response to each challenge and the kinetics     of that response.      For Cohorts 1A and 1B, 16 subjects will receive an initial subcutaneous (SC) 5 mg dose of     KLH. Fifteen days later the subjects will receive 0.1 mg ID KLH dose and the response will     then be assessed 48 and 120 hours after the initial challenge. The ID KLH challenge will then     be repeated 28 days later and the response will be assessed at 48 hours (Cohort 1A, 8     subjects) and at 120 hours (Cohort 1B, 8 subjects) post challenge. For Cohort 2, a repeat     challenge of either 2 tuberculin Unit (TU) or 10 TU ID PPD will be administered 28 days     apart, to 8 subjects. The first challenge response will be assessed 48 and 120 hours post     challenge. The second challenge will be administered 28 days after the first and will be     assessed at the same timepoints. The repeat challenge 28 days later will allow an     intra-subject analysis and will determine if a subject can be used as their own control. Part     C of the study will assess repeat ID challenges of PPD and PBS; the objective will be to     characterise the T-cell response to each challenge and the kinetics of that response. For     Cohort 1, 6 subjects will receive a 0.1ml ID dose of PBS and another dose 24 hours later.     Each challenge will be assessed 48 hours post challenge. Approximately 2 subjects will have     an assessment of their normal skin as a control. For Cohort 2, a repeat challenge of either     2TU or 10TU ID PPD will be administered 28 days apart, to 6 subjects. The first challenge     response will be assessed 48 post challenge. The second challenge will be administered 28     days after the 1st and will be assessed at the same timepoint. The repeat challenge 28 days     later will allow an intra-subject analysis and will determine if a subject can be used as     their own control.      The total duration of this study for Part A is 14-18 days plus up to 30 days screening. The     total duration of this study for Cohort 1A is 56-60 days plus up to 30 days screening. The     total duration of this study for Cohort 1B is 59-63 days plus up to 30 days screening. The     total duration of this study for Cohort 2 if 2TU is used is 45-49 days plus up to 30 day     screening. The total duration of this study for Cohort 2 if 10TU is used is 48-51 days plus     up to 30 days screening. The total duration of this study for Part C Cohort 1 is 15-19 days     plus up to 30 day screening. The total duration of this study for Cohort 2 if 2TU is used is     42-46 days plus up to 30 day screening. The total duration of this study for Cohort 2 if 10TU     is used is 45-49 days plus up to 30 days screening.   "
105084|NCT01910649|"     The purpose of the extension phase of this study is to determine whether Drisapersen is     effective in the treatment of boys with Duchenne muscular dystrophy resulting from a mutation     thought to be corrected by exon 51 skipping.   "
105085|NCT01910636|"     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF)     plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV)     infection.   "
105086|NCT01910623|"     This study will focus on acute promyelocytic leukemia patients who have been diagnosed more     than 5 years ago and their present quality of life.      The possible late effects of cancer treatment can include several issues and, thus, there has     been an increasing interest worldwide in studying the long-term impact of these in patients'     life.   "
105087|NCT01910610|"     STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with     metastatic colorectal cancer.   "
105088|NCT01910597|"     Soluble Beta-Glucan (SBG) is a compound prepared from commercial active dry Baker's yeast     which is then proceeded through a multi-step laboratory processes invented by Prof. Rapepun     Wititsuwannakul, Faculty of Science, Prince of Songkla University, Thailand. Based upon     pre-clinical data, SBG has been shown to inhibit angiogenesis and probably enhance immune     function, leading to shrinkage of tumor size in athymic nude mice injected by hepatocellular     carcinoma cells (HepG2) and cervical cancer cells. Therefore, the investigators expect to see     the safety and anti-cancer property of SBG in patients with advanced cancer whom no available     therapy can be offered.   "
105089|NCT01910584|"     The aim of this study is to investigate the influence on the quality of life and sexual     function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of     Menorrhagia.   "
105090|NCT01910571|"     -  This is a single centre, phase I, randomized, double-blind, placebo-controlled,          crossover, dose escalating study of P7435 using single and multiple doses, to be          conducted in healthy male and female (Non child bearing) subjects having BMI between 19          to 40 kg/m2.        -  The study will be conducted in 2 parts as follows: Part A will consist of the Single          Ascending Dose (SAD) study and Part B will consist of the Multiple Ascending Dose (MAD)          study.   "
105132|NCT01910012|"     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been     used to treat patients that have cancers that require arginine. In this study, the     investigators will evaluate the response rate, as determined by the revised International     Working Group recommendations.   "
105092|NCT01910545|"     The purpose of this study is to test the safety and tolerability of an investigational drug     called OTS167. OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which     demonstrated antitumor properties in laboratory tests. It is being developed as an     anti-cancer drug. In this first-in-human study OTS167 will be administered to patients with     solid tumors which have not responded to treatment.   "
105093|NCT01910532|"     This is a single-arm, open label safety and dose titration study evaluating the use of     Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial     Pressure Monitoring device.   "
105094|NCT01910519|"     This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent     Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine     with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by     the A/H5N1 bird flu virus in Europe but none of the vaccines to be used in the study are     approved for use in the United States. The results of this study will help researchers learn     about better ways to vaccinate people against the H5N1 flu.   "
105095|NCT01910506|"     This study will determine the characteristics of absorption, metabolism, and excretion (AME)     of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries     (µCi) of [14 C]RDEA3170 in healthy adult male subjects.   "
105096|NCT01910493|"     Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to     improve health outcomes. However, robust data on the efficacy of SMS on health seeking     behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study aims     to assess whether regular SMS-reminders improve retention on antiretroviral therapy (ART) and     prevention of mother to child transmission of HIV (PMTCT) programmes in Mozambique.   "
105097|NCT01910480|"     The purposes of this study are to: learn about the safety of the study drug (NBI-98854);     learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK     testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug)     of the investigational study drug after taking it alone and with ketoconazole. Ketoconazole     is known to affect the PK of many drugs and is studied to more safely prescribe medications.   "
105098|NCT01910467|"     Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number of     hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared     spectroscopy in combination with predefined interventions and secondly to explore the     potential impact on cerebral injury and mortality.      Hypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation     ratio investigators will reduce hypotensive episodes and use of catecholamines which will     reduce cerebral injury and mortality.      Methods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300) will     be measured for 24h starting <6 hours postpartum. When cTOI/pTOI ratio increases >5% within a     6h period, predefined interventions will be performed.      Primary outcome parameter will be duration of hypotensive episodes and use of catecholamines     during the first 48h after birth. Secondary outcome parameters will be cerebral injury and     mortality.   "
105099|NCT01910454|"     Stroke is the most serious disabling condition in the United States and the developed world.     Novel stroke rehabilitation approaches, such as task-specific training, have shown promise in     improving an individual's recovery in the rehabilitation setting; however, evidence suggests     that these improvements are not generalized or transferred to the home, community, or work     settings. Thus, these interventions usually do not impact overall health and participation     outcomes. This research study seeks to improve task-specific training as a stroke     rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies     which have shown great promise as a way to address the limitations of task-specific training.     The new treatment protocol is called Cognitive-Oriented Strategy Training Augmented     Rehabilitation, or COSTAR. The hypothesis of this study is that COSTAR will result in more     efficient functional skill acquisition, better long-term retention of skills learned, and     generalization and transfer of skills learned to home, community, and work settings.   "
105100|NCT01910441|"     Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on     glucose variability in T2DM patients.   "
105101|NCT01910428|"     Asparaginase (Asp) is used during the induction phase of ALL treatment for children and young     adults. Its efficacy is counterbalanced by its toxicity, mainly in patients 40 years or     older. The efficacy rate in older adult population is lower than for children or young     adults. A recent review on outcomes in older adults with ALL pointed out that there were     significantly more drug reductions, omissions or delays in the older group as compared to     younger adults and that asparaginase was the drug most commonly omitted.      The investigational product ERYASPASE is a dispersion for infusion of homologous red blood     cells (RBC) encapsulating E. coli L-asparaginase.      A previous European phase I/II clinical study in children and adults (<55 yo) at first     relapse of ALL was conducted to determine the optimal dose of homologous RBC encapsulating     native E. coli Asp (GRASPA®) in 24 patients with relapsed ALL. The activity and safety     profiles of 3 doses of GRASPA® (50, 100 and 150 IU/kg) in combination with standard     chemotherapy were compared to free native Asp. The global safety profile is also improved,     reducing hypersensitivity, liver toxicity and coagulation disorders. Study showed that a     single dose of GRASPA® 150 IU/kg induced a depletion in plasmatic asparagine for 18.6 days,     i.e. similar to that obtained with 8 injections of 10,000 IU/m² of free native Asp. A     reduction in the incidence and severity of the allergic reactions and coagulation disorders     were observed with GRASPA® (Domenech 2011).      A French phase II study designed to determine the maximum tolerated dose of GRASPA® in     combination with a polychemotherapy regimen in ALL patients older than 55 yo at first     diagnosis has been performed, and showed that both 100 and 150 IU/kg doses fulfilled the     predefined criteria for efficacy and tolerability but the better profile of 100 IU/kg dose     was considered the optimal dose in this setting. A phase II/III trial in adult and children     patients with relapsed ALL is currently ongoing.      Based on these results, the combination of ERYASPASE with the CALGB chemotherapy regimen     appears to be an attractive combination for the treatment of adults patients with ALL/LBL.   "
105102|NCT01910415|"     This study is designed to evaluate the effect of multiple doses of lumacaftor in combination     with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart     rate in healthy subjects.   "
105103|NCT01910402|"     This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC     fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV)     and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in     HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety     and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of     subjects will be screened in order to ensure a total of approximately 474 subjects will be     randomized (237 in each study arm)   "
105228|NCT01908751|"     The purpose of this study is to determine the impact of surgical fixation (cancellous screws     versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient     important outcomes.   "
105104|NCT01910389|"     This study is a multi-center, prospective, randomized, double blind, placebo-controlled     clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA)     Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left     ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The     purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil     compared to placebo on the subjects' functional capacity / quality of life.   "
105105|NCT01910376|"     Cancer is a disease of the elderly. Cancer incidence is 11-fold higher in persons over the     age of 65, than in younger ones. Approximately 60% of all cancers and 70% of cancer mortality     occurs in people older than 65 years. Moreover, due to the aging of the population in the     Western world the number of elderly people is expected to increase and therefore the number     of older cancer patients is expected to rise. Despite this rapid increase in cancer incidence     and cancer-related mortality with age, our knowledge about ageing and cancer and about     optimal treatment for older cancer patients is still far from adequate. Therefore, it is     clear that cancer in the elderly is a major and increasing health problem. A key problem in     geriatric oncology research is the important selection bias because very old/frail patients,     are very rarely included in clinical trials.      Changes in the patterns of health care delivery have shifted the care of the elderly from     acute care settings to the community and long-term care facilities. As the European     population ages, more and more people will become nursing home residents, many of whom will     have a suspicion of, or be diagnosed with, and eventually die from, cancer. Although cancer     is very common in elderly nursing home residents, it is poorly studied. This lack of     information may impact on clinical decision making and the appropriateness of treatments     offered and therefore collection of this information is needed.      This project has two main objectives. The first objective is to report on demographics,     referral patterns and motives for non-referral, anti-cancer treatments and outcome of     patients in nursing homes with suspected or diagnosed active invasive cancer where a     diagnostic or treatment decision has to be taken. The second objective is to develop better     prognostic tools (for survival) including biological markers of ageing to help treatment     decisions in the elderly.   "
105106|NCT01910363|"     To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for     treating stroke patients with lower limb spasticity.        -  we study the degree of spasticity in the ankle and knee joints, and walking speed in 30          patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded          manner as for the patient, the physician, and the examiner.        -  we also assess the safety of A2NTX and compare it to that of BOTOX.   "
105107|NCT01910350|"     1) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and     appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To     determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and     appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To     measure functional cancer literacy over time at the individual and familial level and 4)     Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and     control-comparison groups.   "
105108|NCT01910337|"     The purpose of this study is to use heart rate variability as a monitor of cardiovascular     safety during third molar surgeries, using the Polar heart rate-meter.   "
105109|NCT01910324|"     The fundamental objective of the proposed study is to develop and test an innovative     two-stage, cross-systems family-based intervention for substance abusing juvenile offenders.     The first stage of the experimental treatment is provided for youths in juvenile detention     settings. Stage two of the intervention occurs after the offender is released to the     community. Participants are randomized to one of two study conditions: the cross-systems     family-based intervention (Multidimensional Family Therapy-Cross Systems (MDFT-CS), or 2)     Enhanced Services as Usual (ESAU). Both conditions incorporate HIV prevention in detention     and we will also examine the effects of a family-based HIV/STD prevention module beyond the     impact of a standard HIV/STD education intervention delivered in detention by including     ongoing HIV/STD intervention in MDFT-CS following release from detention. There are five aims     of the proposed study. These aims relate to: 1) Intervention development and implementation;     2) Clinical effectiveness; 3) Impact of HIV/AIDS/STD prevention; 4) Comparative     benefit-costs; and 5) Systems-level impact   "
105110|NCT01910311|"     The purposes of this study are to look at what effect multiple doses of rifampicin have on a     single dose of baricitinib and to look at the safety and tolerability of these drugs. Side     effects will be documented. The study will last approximately 31 days from the first dose to     the end of the study.   "
105111|NCT01910298|"     This is a prospective, multicenter, non-randomized, parallel design comparing a primary     efficacy endpoint between subjects undergoing immediate post-mastectomy breast reconstruction     with a breast implant and Strattice™ Reconstructive Tissue Matrix (TM) and subjects     undergoing immediate, two-stage post-mastectomy breast reconstruction, where the initially     placed expander will be exchanged for a breast implant only, without any type of     reinforcement.   "
105112|NCT01910285|"     The main objective is the comparison of intubation conditions after anesthetic induction     bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients     undergoing surgery for tooth extraction.      Intubation without myorelaxant with propofol and sufentanil is classic but less efficient     than induction with curare on achieving perfect intubation conditions. The use of a protocol     without curare is sometimes justified for short gestures or when you want to avoid allergia.     Remifentanil often provides excellent intubation conditions without myorelaxant. However,     remifentanil was never compared to sufentanil in terms of intubating conditions without     muscle relaxant.   "
105113|NCT01910272|"     Invasive cardiac procedures involve procedural guidance with x-rays in the form of     fluoroscopy. X-ray exposure poses a potential risk of acute and long-term complications to     staff involved in these procedures. Lead shields are placed between the operators (on their     left side) and the x-ray source to limit exposure. However as the operator requires direct     access to the patient and x-ray scatter occurs, full protection is not possible. Lead gowns,     thyroid collars, and leaded glasses are typically worn to protect the body, thyroid, and eyes     respectively, but their thickness is limited by their relatively heavy weight. Nevertheless     this leaves the brain exposed. Further, interest in the risk of brain cancer in invasive     cardiologists has re-emerged after a recent report of left-sided brain cancer in primary     operators of interventional cardiology procedures. Lead caps have been tested in the past but     the relatively heavyweight of lead has limited wide-spread implementation. The cap typically     worn during invasive procedures is lightweight, has no significant x-ray absorption     properties, and is worn to help maintain a sterile environment. A novel, lead-free cap,     composed mainly of barium sulfate and bismuth oxide, has been developed that has been shown     to absorb x-rays while being significantly lighter than lead. The investigators propose using     multiple x-ray detectors to test exposure differences between the primary and secondary     operators, the left side and right side of the head, and absorption via a lead-free cap.   "
105114|NCT01910259|"     Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects     approximately 100,000 people in the UK. Many patients with MS experience two phases of     disease; early MS (also called relapsing remitting MS, RRMS) and late MS (also called     secondary progressive MS (SPMS). Early MS is due to inflammation of the nerves and the     insulation (called myelin) that surrounds the nerves. Early MS is often characterised by     periods of attacks interspersed with periods of remission with no or low disease     symptoms. Late or progressive MS, which affects the majority of patients and typically     emerges after 10-15 years of disease, results from actual nerve death (also called     neurodegeneration). The progressive stage of disease results not in individual attacks but     slow, cumulative and irreversible disability affecting walking, balance, vision, cognition,     pain control, bladder and bowel function. Critically, and unlike early disease, there is no     proven treatment for the late stage of MS. This is therefore an urgent and major unmet health     need. MS-SMART directly addresses this need and will evaluate in this clinical trial three     drugs (fluoxetine, riluzole or amiloride), all of which have shown some promise in MS, and in     particular in SPMS. The trial is randomised and blinded. Randomisation means patients can get     any one of the three active drugs or the inactive placebo/dummy; blinded means that neither     patients nor the doctors will know which drug or placebo patients are receiving.     Randomisation and blinding are standard approaches in clinical trials to ensure unbiased     testing of drugs. All patients in MS-SMART will have periodic MRI (magnetic resonance     imaging) brain scans and after 96 weeks these will be analysed. We will then compare the     scans of each drug to the placebo or dummy to see if any of the drugs slow the rate of brain     shrinkage that normally occurs in SPMS. This measured change in brain size is the primary     (major) outcome of MS-SMART.   "
105115|NCT01910246|"     It has been shown that asymptomatic obese adolescents can demonstrate abnormal regional     myocardial contraction, with preserved global cardiac function. Metformin has been shown to     decrease cardiovascular mortality in patients with type 2 diabetes and insulin resistance,     but the mechanism of cardiovascular protection is unknown.      The purpose of this study is to evaluate the reversibility of subclinical cardiovascular     abnormalities in obese adolescents with insulin resistance after a six-month course of     Metformin. The investigators hypothesized that the beneficial effects of Metformin will be     progressive and sustained after six months of therapy.   "
105116|NCT01910233|"     This is a prospective registry of patients presenting with acute dyspnea to the emergency     department of the city hospital in Nuremberg. There is evidence that acute dyspnea is     associated with a mortality rate of 10%, however acute dyspnea is not perceived as a     life-threatening condition, both in public and in health care providers. Our aim is to     describe the patient collective concerning their demographics, baseline characteristics, type     of referral and disposition, medical care processes and prognosis. Secondly, we want to     evaluate if the subjective risk assessment of emergency department personnel matches with     objective risk stratification tools and the actual outcome of the studied patients.   "
105117|NCT01910220|"     This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy     volunteers.   "
105118|NCT01910194|"     Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion     and gastric emptying   "
105119|NCT01910181|"     This open-label, multicenter study will evaluate the pharmacokinetics, safety and efficacy of     vemurafenib in Chinese participants with BRAF V600 mutation-positive unresectable or     metastatic melanoma. Participants will receive vemurafenib 960 milligrams (mg) orally twice     daily until disease progression or unacceptable toxicity occurs.   "
105120|NCT01910168|"     In this single center study blood samples for biomarker analysis will be collected from     patients with spinal muscular atrophy. Up to 21 mL blood will be drawn from eligible patients     at a single visit.   "
105121|NCT01910155|"     The objective of this study is to compare the relative efficacy and safety of the test     formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par     Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin     0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial     otitis externa.   "
105122|NCT01910142|"     The present study aims to develop a technique based on a single dose of a calcium isotope,     which enables to determine the effect of a nutritional intervention on bone calcium     metabolism. For this purpose nutritional interventions with calcium, vitamin D and vitamin K     will be applied in postmenopausal women. Treatment effects will be determined by the urinary     excretion of the calcium isotope and related to classical bone markers.   "
105123|NCT01910129|"     The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for     the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.   "
105124|NCT01910116|"     GCSB-5 (Shinbaro capsule), is a mixture of 6 oriental herbs that have anti-inflammatory and     analgesic effects along with an excellent safety profile. This study is aimed at     investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long     term treatment in a placebo controlled, double-blind randomized trial.   "
105125|NCT01910103|"     Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the     that of breast ultrasound in women with dense breast.   "
105126|NCT01910090|"     To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg     MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé & PEPCID® (Famotidine)     20mg Tablets, USP.   "
105127|NCT01910077|"     The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and     prograf capsule 1mg.   "
105128|NCT01910064|"     This open label study is to determine the safety profile of GK530G in a long-term treatment     (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a     long-term treatment.   "
105129|NCT01910051|"     The rationale for this trial is to apply a simple and minimally strenuous pre-screening     approach prior to performing more extensive trial-specific screening and     baseline-characterization activities in the resulting pre-selected population of subjects.   "
105130|NCT01910038|"     The usual percentage of patients receiving 0.1 mg/Kg/d or less of prednisone after 6 months     of treatment is approximately 40%. We believe that adding tocilizumab to the corticotherapy     in this protocol could increase the percentage from 40 to 70%.      From an immunological point of view, we believe we will see not only a fall in the Th17     response (as with corticoids alone), but also a rise in Treg lymphocytes.   "
105131|NCT01910025|"     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been     used to treat patients that have cancers that have arginine. In this study, the primary     efficacy variable will be assessment of tumor response rate.   "
105133|NCT01909999|"     The aim of this study was to compare the release of the osteoprotegerin (OPG), transforming     growth factors (TGF-α), osteocalcin (OCN), osteopontin (OPN), and parathyroid hormone (PTH)     during osseointegration of dental implants with and without immediate loading. Forty patients     were selected and randomly divided into: Group IM - implant and prosthesis placement within     72 hours; and Group NL - implant insertion and no prosthesis placement during 120 days.     Peri-implant crevicular fluid (PICF) was collected immediately after implant insertion and     with 7, 15, 30, 60, 90, and 120 days after surgery and were evaluated levels of OPG, TGF-α,     OCN, OPN and PTH using Luminex assay. Clinical aspects (Sulcus bleeding and peri-implant     probing depth) were also assessed. The data were compared using the ANOVA/Tukey and     Friedman/Mann-Whitney tests (α=5%).   "
105134|NCT01909986|"     This is a single dose mass balance study in healthy adult male volunteers to investigate the     metabolism and excretion of [14C]-ONO-4053.   "
105135|NCT01909973|"     The goal of this project is to develop and pilot a mobile smartphone delivered intervention     that will improve antidepressant medication care by providing medication adherence monitoring     and support to the patient, feedback on patient adherence and response to treatment to the     primary care team, and information to both patients and providers on guideline-congruent care     personalized to the patient's response to antidepressant medication.   "
105136|NCT01909960|"     Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid     and blood flow by phase contrast magnetic resonance imaging.   "
105137|NCT01909947|"     The investigators hypothesize that machine learning methods using a combination of novel,     quantitative measures of cardio-respiratory variability can accurately predict the optimal     time to extubate extreme preterm infants. In this multicenter prospective study,     cardiorespiratory signals will be recorded from 250 extreme preterm infants who are eligible     for extubation. Automated signal analysis algorithms will compute a variety of metrics for     each infant describing the cardiorespiratory state. Machine learning methods will then be     used to find the optimal combination of these statistical measures and clinical features that     provide the best overall predictor of extubation readiness. Finally, investigators will     develop an Automated system for Prediction of EXtubation (APEX) that will integrate the     software for data acquisition, signal analysis, and outcome prediction into a single     application suitable for use by medical personnel in the Neonatal Intensive Care Unit (NICU).     The performance of APEX will later be clinically validated in 50 additional infants     prospectively.   "
105138|NCT01909934|"     This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the     efficacy and safety of brentuximab vedotin as a single agent in patients with relapsed or     refractory Systemic Anaplastic Large Cell Lymphoma (SALCL).   "
105139|NCT01909921|"     The purpose of this study is to assess the effectiveness of a Relaxation Response     Intervention for Depression offered to low income populations at Massachusetts General     Hospital (MGH) - Chelsea, Revere and Charlestown health centers.   "
105140|NCT01909908|"     The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a     clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM)     and autologous blood products in wound healing.   "
105141|NCT01909895|"     Study aims and hypotheses are as follows:      Primary Hypotheses:      Compared to the neutral condition, the anger recall task will acutely induce endothelial     dysfunction by impairing endothelium-dependent arterial vasodilation (Hypothesis 1a);     increasing circulating levels of EC-derived microparticles (EMPs), a marker of EC injury     (Hypothesis 1b); and reducing circulating levels of bone marrow-derived endothelial     progenitor cells (EPCs), a marker of EC reparative capacity (Hypothesis 1c).      Secondary Hypotheses:      Compared to the neutral condition, the depressed mood and separately the anxiety recall tasks     will acutely impair endothelium-dependent arterial vasodilation, increase circulating levels     of EMPs, and reduce circulating levels of bone marrow-derived EPCs. There will be a relation     of the level of self-reported anger, depressed mood, and anxiety with endothelial     dysfunction.   "
105142|NCT01909882|"     The effect of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score     of hospitalized patients in Intensive Care Unit: A Triple-blinded Randomized controlled     Clinical Trial Study   "
105143|NCT01909869|"     One of the purpose of this study is to assess the preliminary safety and feasibility,and to     provide related information and evidence for the design of the further pivotal randomized     control trial.the other purpose is to assess the performace of the stent delivery system.   "
105144|NCT01909856|"     This study is to assess the efficacy and safety of palonosetron in preventing the acute and     delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover     design is used and granisetron is the positive control.   "
105145|NCT01909843|"     This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent     reversibility and prevention, of bronchoconstriction following single and repeated oral     inhalations of ALX-0171 in adults with hyperresponsive airways.      This phase I study is an exploratory study and serves to evaluate the occurrence and     reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label     trial with a sequential administration regimen of placebo and verum in all planned study     subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (=     formulation buffer) followed by escalating doses of ALX-0171 verum.      Eventually a second administration of ALX-0171 placebo may take place at the end of the study     (as defined per protocol).   "
105146|NCT01909830|"     Study Design:      Multicenter, non randomized, open label phase II study designed to evaluate the efficacy and     safety of Gemcitabine/Pemetrexed combination.      Enrollment period: 18 months. Treatment period: maximum for 24 weeks for each patient (12     cycles lasting 2 weeks).      Total duration of the study: 24 months.      Number of Subjects:      Approximately 38 subjects will be enrolled on study:      - First stage:12 patients enrolled      If 1 or 0 responses were observed, the trial had to be terminated:      - Second stage: an additional of 23 patients were to be enrolled. If 5 or less responses were     observed in 35 patients, the combination would not be considered worthy of further study,     while if 6 or more responses were observed, the combination would be considered sufficiently     active to warrant further testing. Taking into account an invalidity rate of 5%, 38 patients     will be needed for this step.   "
105147|NCT01909817|"     The investigators aim to determine whether a new method of enhancing and improving ECG     acquisition, analysis and display is effective. The investigators will perform     superimposition and summation of multiple standard ECG cycles, in the same lead, by temporal     alignment to the peak R wave and voltage alignment to an improved baseline at the T-P     segment.   "
105148|NCT01909804|"     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and     tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)     in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV)     infection.   "
105149|NCT01909791|"     Although multiple studies have clearly demonstrated that ranibizumab therapy is more     effective than laser alone for vision gain and avoiding vision loss in patients with     central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a     visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse)     were eligible. Eyes that have central-involved DME with good visual acuity (20/25 or     better) have not been addressed systematically by recent studies for treatment of DME.     Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS)     suggest that a substantial percentage of eyes with central-involved DME may retain good     vision. The investigators do not know definitively whether eyes with central-involved DME and     good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept)     therapy initially, or focal/grid laser treatment or observation initially followed by     anti-VEGF only if vision worsens.      The primary objective of the protocol is to compare the % of eyes that have lost at least 5     letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with     central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or     better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid     photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt     anti-VEGF.      Secondary objectives include:        -  Comparing other visual acuity outcomes between treatment groups, such as the percent of          eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual          acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean          visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity        -  For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF          treatment        -  Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT          central subfield (CSF) thickness, adjusted for baseline mean thickness        -  Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding          vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between          treatment groups        -  Comparing safety outcomes between treatment groups        -  Comparing associated treatment and follow-up exam costs between treatment groups   "
105150|NCT01909778|"     This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI     201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A     according to Child-Pugh classification (< 7 points).   "
105151|NCT01909765|"     To compare the effect of two different surgical techniques, the dorsal slit and double     incision technique, on postoperative pain.   "
105152|NCT01909752|"     This study will test an investigational vaccine, called DRibbles, for the treatment of     non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine     will cause an immune responses against proteins contained in the DRibble vaccine and the     protein antigens targeted by this strong immune response will include common antigens shared     by both the vaccine and the patient's tumor.   "
105153|NCT01909739|"     The aim of this study is to examine the association between preoperative statin treatment and     the incidence of postoperative acute kidney injury(AKI) in patients undergoing valvular heart     surgery.   "
105154|NCT01909726|"     The purpose of this study is to test the hypothesis that providing low-intensity     opportunities for interactive play can improve the waiting and overall clinic experiences of     children. This study evaluates an innovative, interactive system called ScreenPlay designed     to realize the intentions of the Healing Environment in the waiting space of a paediatric     hospital.   "
105155|NCT01909713|"     The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam     Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.   "
105156|NCT01909700|"     Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is     feasible, safe and effective for women with moderate pelvic organ prolapse.      Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a     single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome     measures for this study were the operative safety and post-operative pain, adverse effects     and anatomical as well as functional cure.      Setting: The operations were performed under general anesthesia according with the reported     surgical techniques at university and private hospitals.   "
105157|NCT01909687|"     System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test     strips per systems according to ISO 15197:2013   "
105158|NCT01909674|"     Our group previously conducted a study looking at the performance of three styles of positive     airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we     found that patients using a full-mask mask required higher positive airway pressures than     patients using nasal or nasal pillows style masks to achieve successful reduction of     respiratory events. In the current study we want to randomly assign patients to either nasal     or full-face masks and then switch to a different mask (if nasal was originally chosen than     the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the     number of respiratory events change with the different mask style. We expect the number of     respiratory events will increase with the use of full-face masks.   "
105159|NCT01909661|"     The objective of this double blinded randomized study is to assess the tolerance of two     extensively protein hydrolyzed infant formulas, one based on rice protein and the other one     on casein, at introduction, and after 3 months of consumption, and their efficacy on growth     and on the reduction of allergy symptoms through a 3 months consumption period.   "
105160|NCT01909648|"     The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on     routine HbA1c measurements.   "
105161|NCT01909635|"     Kelsey Wallour and Dr. Hollie Raynor are doing a study to investigate the effect of focusing     on certain thoughts and feelings during a meal on liking of items in the meal. A total of 36     women are anticipated to participate in this study.   "
105176|NCT01909440|"     This randomized pilot clinical trial studies resistance training and protein supplementation     in increasing lean body mass in patients with prostate cancer receiving androgen deprivation     therapy. Resistance training and protein supplementation may help improve quality of life in     patients with prostate cancer receiving androgen deprivation therapy.   "
105177|NCT01909427|"     The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants     with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.   "
105178|NCT01909414|"     The purpose of this study is to evaluate the safety of two HIV vaccines in HIV-1-infected     young adults who are taking anti-HIV medications and have very low virus levels. This study     will also look at how the immune system responds to the vaccines.   "
105162|NCT01909622|"     Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not     been suspected before. The most cost-effective method for reducing population-wide VDD is     through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification     varies by dose, duration, and population characteristics; and it is currently unknown whether     it could be an efficacious public health intervention to curb the VDD epidemic among children     living in tropical areas. We propose to conduct a randomized, controlled, double blind trial     to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D     concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families     with a child participating in an ongoing cohort study will be randomized to receive one liter     per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim     milk for a six-week period. Caregivers will be instructed to give the index child two cups of     milk per day and to distribute the remaining milk to the rest of the family. We will measure     serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the     intervention period.   "
105163|NCT01909609|"     The American Academy of Pediatrics changed their stance on circumcision to health benefits     of newborn male circumcision outweigh the risks and that the procedure's benefits justify     access to this procedure for families who choose it (AAP, 2012).      We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to     make this medical decision by weighing the risks against the benefits of circumcision, or do     they simply use sociocultural/religious reasons to make this decision? We hypothesize that     parents are unaware of the specific benefits and risks of circumcision, and make this     decision based primarily on sociocultural, religious, and/or familial norms.      Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be     recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to     accrue at least 680 participants for this study in order to achieve statistical significance     and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will     be encouraged to participate.      This survey will assess their desire to get their child circumcised when they are born.     Participants will be asked to list perceived risks and benefits of circumcision. This will     hopefully allow us to see two things: if parents are aware and knowledgeable of the risks and     benefits or circumcision, and what they perceive to be risky or beneficial from a medical     standpoint.      Parents will be randomly given 1 of 2 pieces of information (1 per couple [or per single     mother]; 1 control, 1 experiment) with different information about circumcision. We will see     if there are any outcome differences based on which group the couple randomized into.     Follow-up phone call will serve to assess outcome if baby was circumcised and any factors     that led up to the decision. This will allow us to see if the AAP stance has any effect on     decision making when we compare the control and experiment groups.   "
105164|NCT01909596|"     The purpose of this is to test lateral foot orthoses with different amount of wedging to find     a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical     or feelings measures. This study was a cross-sectional study with patients serving as their     own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and     clinical angles measures was carried out before making orthoses, then motion analysis with an     optoelectronic system was performed with each pair of foot orthoses. During motion analysis,     five gait trials were carried out in each condition.   "
105165|NCT01909583|"     We have developed a pre-operative educational / counselling booklet with the focus on     informing parents / patients about the different stages before, during, and after cardiac     surgery that they will encounter; both chronologically and emotionally. With this approach     and study our objectives are:      1. To provide anticipatory guidance for parents to decrease parental stress and improve     parental experience and preparedness, thus involving the parent as a partner in caring for     their child.      We hypothesize that this additional tool will improve parental satisfaction in regards to     being prepared for their child's heart surgery.   "
105166|NCT01909570|"     The purpose of this study is to determine whether a policy of elective single embryo transfer     (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms     of clinical pregnancy rate   "
105167|NCT01909557|"     To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional     substances administration on work productivity, daily activity, and fatigue in subjects with     chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.   "
105168|NCT01909544|"     The purpose of this study is to investigate whether a localized exercise, in which     cardiorespiratory demand is reduced, will result in greater limb muscle fatigue in patients     with COPD as a consequence of muscle oxygenation and muscle metabolism disturbances.   "
105169|NCT01909531|"     The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness     of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection,     targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.   "
105170|NCT01909518|"     The aim of the present study：        1. To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.        2. To assess the detection rate of early esophageal squamous neoplasia by virtual          chromoendoscopy   "
105171|NCT01909505|"     Low testosterone is a common male problem. The diagnosis of low testosterone often requires     blood sampling and expensive testing. We want to know if measuring saliva testosterone can be     used in place of blood sampling. Study participants will be asked to provide samples of blood     and saliva for the measurement of testosterone. These results may lead to the development of     a saliva test for testosterone.   "
105172|NCT01909492|"     This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.   "
105173|NCT01909479|"     This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter     study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once     weekly injection of modified hGH (MOD-4023).   "
105174|NCT01909466|"     To determine the safety and tolerability of multiple-dose administrations of aripiprazole     intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia   "
105175|NCT01909453|"     This is 2-part, randomized, open label, multi-center, parallel group, phase III study     comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy     in patients with locally advanced unresectable or metastatic melanoma with BRAF V600     mutation. A total of approximately 900 patients will be randomized.      Part 1:      Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:        1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)        2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or        3. vemurafenib 960 mg BID (denoted as vemurafenib arm)      Part 2:      Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:        1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or        2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)   "
105179|NCT01909401|"     Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications     for those preparing for a liver transplant. The purpose of this study is to determine whether     those individuals who require liver transplantation for Hepatitis C, genotype I, who are     undergoing liver transplantation may successfully get rid of their virus before the     transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the     time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect     the new liver that they receive and they will not require therapy for Hepatitis C after liver     transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and     boceprevir, all of which are approved for the treatment of genotype I Hepatitis C.      Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients     with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic     liver transplantation will lead to rapid HCV RNA clearance of genotype I infected     individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new     transplanted graft and prevent graft infection posttransplantation.   "
105180|NCT01909388|"     The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an     appropriate assessment of the local extent of the disease. Recent studies have shown an     increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions     when using multiparametric MRI as a diagnostic tool in the staging of the disease.      Among the various irradiation techniques currently available for prostate cancer,     Brachytherapy is the superior in terms of dose conformation; this conformation allows greater     dose escalation, adjusting the isodoses to the prostate with exquisite accuracy, keeping     healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range      Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.      The purpose of this study is to demonstrate the feasibility of the delivery of a higher than     prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.      Dose to prostate, and adjacent structure will remain the same as the current treatment     practice. Timing and the delivery of brachytherapy will not change from our current practice   "
105181|NCT01909375|"     The American Joint Replacement Registry is a not-for-profit 501(c)(3) organization for data     collection and quality improvement initiatives for total hip and knee replacements. The AJRR     is a collaborative effort supported by the American Academy of Orthopaedic Surgeons (AAOS),     the American Association of Hip and Knee Surgeons (AAHKS), The Hip Society, The Knee Society,     hospitals, health insurers, medical device manufacturers, and contributions from individual     orthopaedic surgeons.   "
105182|NCT01909362|"     Patients are being asked to participate in this study who have colorectal cancer that has     come back after initial treatment. The investigators want to improve treatment in patients     with this disease. In other types of cancers, it has been possible to improve treatment by     studying the gene mutations (called biomarkers) in a patient's cancer and matching these to     existing cancer therapies or study drugs which target that specific mutation. Colorectal     cancers have not been routinely tested in this way.      In this study, investigators will determine whether mutational testing can be successfully     done on colorectal cancers and how often mutations are detected for which there are existing     drugs (or drugs in development). The results will be used to determine if treating physicians     use this information in planning subsequent treatment.   "
105183|NCT01909349|"     Persons undergoing cardiac rehabilitation often have difficulties transferring the learned     health behaviors into their daily routine which decreases their health status. Computer-based     tailored interventions have been shown to be effective in increasing physical activity as     well as fruit and vegetable consumption. The aim of this study is, to support people in     transferring these two learned behavior changes and their antecedents into their daily life     after cardiac rehabilitation in Germany, the Netherlands and China. The primary goal of the     study is to analyze the effectiveness of a rehabilitation aftercare program with regard to     the level of physical activity and nutrition.   "
105184|NCT01909336|"     The purpose of this study is to determine if isotonic solutions reduce the risk of hospital     acquired hyponatremia compared with hypotonic solutions.   "
105185|NCT01909323|"     Digestive symptoms following consumption of low digestibe carbohydrates are generally     assessed product by product but several ingredients can be used simultaneously. The study     aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.   "
105186|NCT01909310|"     After routine induction of general anaesthesia peak airway pressure (= P max) and other     respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and     without head support in three different head positions: neutral position, reclination of the     head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on     different head positions;   "
105187|NCT01909297|"     The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways     in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak     pressure. The investigators also studied their relative ease of insertion, time to insertion     and complications of use as secondary outcome measures.   "
105188|NCT01909284|"     This study is being conducted to investigate the effectiveness and safety of acupuncture for     alleviating pain of spondylosis.   "
105198|NCT01909141|"     Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia     contributes to chronic anovulation commonly encountered in women with PCOS. The first choice     therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics     and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin     sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve     fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial     thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this     study we will compare the effect of combined letrozole-metformin-pioglitazone with that of     combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.   "
105199|NCT01909128|"     The respiratory and gastrointestinal infections are a very common problem with high morbidity     in children. These conditions were due, in general, immaturity and all inexperience of the     immune system, as well as to the particular anatomical structure and function of the     respiratory and gastrointestinal tract still developing. This inevitably means that     school-age children develop disease (as a result of infection) more easily than at later     ages. The frequency and duration of these conditions implies a high discomfort and incur     significant costs in relation to drug administration, the need for hospitalization, days of     absence from school and work days lost by parents.      Recently probiotics, defined as microorganisms that prove able, once ingested in adequate     amounts, exert beneficial functions for the body have been proposed for the treatment of     treatment of respiratory and gastrointestinal infections of childhood but only in recent     years have been conducted controlled clinical trials that have conclusively proven     effectiveness. All probiotics induce an immune response, the characteristics of which are     related to the strain or the mixture of bacteria used. Recent studies have demonstrated     positive effects of probiotics on the respiratory system, and in particular on the prevention     and reduction of the severity of respiratory infections, probably mediated by an increase of     cells that secrete Immunoglobulin A in bronchial mucosa. It 'been shown that probiotics can     be a sure way to reduce the risk of early acute otitis media and the use of antibiotics for     recurrent respiratory infections during the first year of life. Similar results were seen in     a study conducted on a population of 326 children aged between 3 and 5 years, who found a     decrease in the incidence of antibiotic use by over 65% and a reduction of days of absence of     more than 25% among children treated with a probiotic. Many of the studied effects of     probiotics, understandably, refer to the digestive system. These effects relate to both     conditions paraphysiological (constipation) and more specifically in situations of illness.      Most of the studies carried out in recent years has demonstrated the efficacy of specific     probiotics in reducing the symptoms in the pediatric population affected by infectious     gastroenteritis. Probiotics reduce the duration of infectious diarrhea by 0.7 days and reduce     the frequency of diarrheal episodes in the first few hours.      The microbiota on the other hand participates in the function of the mucosal barrier against     the adhesion of pathogenic bacteria, crucial time for the start of the infectious process.      When this barrier function is altered by chemical agents, by antigens or by stressors of     different nature, may manifest intestinal disorders, sometimes due to the growth of bacteria     pathogens. Numerous experimental data suggest that probiotics can contribute to the     reinforcement of the activities of gut mucosal barrier, in particular aspects affecting the     functionality of the intestinal epithelial cells or macrophages.      More recently it has been shown that daily intake for 3 months of preparation with probiotics     reduce the incidence and severity of the most common respiratory infections and limits the     number of days of absence school children during the winter season.      It's scientifically recognized as some probiotic effects can also be obtained with the use of     inactivated bacteria or bacterial components isolated (eg bacterial DNA). It has been     recently proposed a modified definition of probiotic products as prepared bacterial cells or     bacterial components that have a beneficial effect on the health and welfare of the host.      Among these products probiotic-like fall ingredients object of this study: food ingredients     (rice flour and skim milk) fermented, or in which has been made to grow a probiotic     (Lactobacillus CBA-L74) that has been inactivated at the end of the fermentation process     through a heat treatment. The benefits are attributable to bacterial components that remain     in the final product (for example, DNA, cell wall, etc.) and factors produced during the     fermentation (short chain fatty acids, bacterial proteins, etc.).      The main effects of these bacterial components relate to the stimulation of the     gastrointestinal tract associated lymphoid tissue (GALT), through interaction with the immune     cells via Toll-like receptors.      In addition, some components, such as proteins and peptides, may have a Bifidogenic activity     and are available in the literature some studies that have demonstrated the ability of infant     formula, milk-based fermented to reduce the severity of episodes of infectious diarrhea in     children.      With this data, the Commission of the European Society of Nutrition Gastroenterology,     Hepatology and Pediatric Nutrition (ESPGHAN) has defined this type of products are not only     safe but to determine a potential prebiotic effect and the reduction of the severity of     episodes of infectious diarrhea.   "
105229|NCT01908738|"     The purpose of this study to determine effectiveness of paracervical block, lidocaine spray     and only oral analgesic drugs for pain relief during endometrial biopsy.   "
105230|NCT01908725|"     The overall objective of this trial is to provide aftercare treatment with Lamazym and to     evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis     whom previously participated in Lamazym-trial.   "
105189|NCT01909271|"     Stroke is the leading cause of adult disability and costs U.S. taxpayers >$60 billion     annually. Interventions designed to educate patients to seek treatment sooner when a stroke     occurs may increase low rates of treatment with thrombolysis (current rates 3% national     average). Thrombolysis can increase the odds of minimal to zero disability from stroke if     emergency medical system response times and in-hospital response times are optimized (maximum     time from symptom onset to intravenous thrombolysis is 4.5 hours). Black and Hispanic     Americans have higher stroke incidence compared to Whites and are less likely to receive     thrombolysis for acute stroke. The latency to hospital arrival is largely dependent on     patients'recognition of stroke symptoms, and immediate presentation to the emergency     department. Our group has found very low stroke literacy rates among Blacks and Hispanics     compared to Whites, which may, in part, be responsible for disparities in acute stroke     treatment. Building on our previous work, in which the investigators have identified barriers     to increasing stroke literacy and behavioral intent to call 911, the investigators will     develop and evaluate the effectiveness of a novel, culturally tailored intervention using     storytelling (narrative persuasion) in the form of two professionally produced 12-min films     (in English and Spanish), in minority populations in New York City. The investigators     hypothesize that participants in the intervention arm (who view the stroke education film)     will demonstrate greater behavioral intent to call 911 for suspected stroke compared to those     in the usual care arm, who will receive written stroke education materials. Behavioral intent     to call 911 will be assessed immediately after viewing the film, 6 months later, and one year     later.   "
105190|NCT01909258|"     The main objective of this study is to describe for the first time the expansion reserve of     the pelvic area (measurements using the EOS system) for each of the four morphotypes     (Roussouly classification) commonly found in a population of healthy volunteers.   "
105191|NCT01909245|"     City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on     islet cell transplantation, an experimental procedure being evaluated as a treatment for     patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing     cells from organ donors and transplanting them into the liver of a patient with diabetes.     Once transplanted, the islets produce insulin, which can improve blood sugar control and     eliminate the need to inject insulin or use an insulin pump.      Anti-thymocyte globulin (ATG) is an anti-rejection medication that works by decreasing a     patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted     things like infections but can also attack transplanted cells and organs. Reducing the number     of T-cells at the time of transplant is expected to protect islets and improve long-term     transplant results. Transplant programs around the world have seen improved islet transplant     results using T-cell depleting medications. Approximately 5-6 out of every 10 patients remain     off insulin five years after transplant. These results are similar to those achieved with     whole pancreas transplant without requiring major surgery, and therefore, may be an option     for patients who are not eligible for a whole pancreas transplant.      The purpose of this study is to determine if islet cell transplantation using ATG, along with     additional medications to prevent the body from rejecting the transplanted cells, is a safe     and effective treatment for type 1 diabetes. Study participants may receive up to three islet     transplants and will be followed for five years to monitor blood sugar control, islet     transplant function, and changes in quality of life.   "
105192|NCT01909232|"     The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe     and effective in the treatment of depression in people who do not get better with     antidepressant medications or cannot take antidepressant medications.   "
105193|NCT01909219|"     This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients     aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated     to higher efficacy and acceptability in comparison to the standard dose regimen in bowel     cleansing before colonoscopy   "
105194|NCT01909193|"     Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual     cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1).      Outcome measures will be social anxiety symptoms and severity as measured by gold standard     questionnaires as well as diagnosis of social anxiety disorder derived from structured     clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.      The investigators expect to find significant reduction in social anxiety symptoms in all of     the groups, with the cognitive behavior therapy group showing greater reduction in symptoms     than the other groups. Mechanisms of change in all of the groups will be examined via     measures of cognitive biases, affect, and other common and specific factors.   "
105195|NCT01909180|"     An external evaluation to obtain clinical data to create sample clinical images.      The data will also be used for product and technology development, marketing materials, and     inclusion in publications.   "
105196|NCT01909167|"     Most depression during pregnancy is undetected and untreated although it is known to be     harmful both to the woman herself and her future child. When these mental disorders are     detected, psychotherapies remain difficult to access, especially in primary care, despite     being effective.Also, prenatal depression is known to be a strong risk factor for postnatal     depression and may prejudice the mother-infant relationship. This leads us to the following     question: Will individual Cognitive Behavioral Therapy (CBT) delivered online be a more     effective treatment for symptoms of depression in pregnant women, than treatment as usual     (TAU)?      The proposed randomized controlled trial aims at evaluating the efficacy of internet based     cognitive behavioural therapy(CBT) delivered individually via skype, using video and audio     resources, by a fully trained psychotherapist, compared to treatment as usual, in women     suffering from symptoms of depression in pregnancy.      Hypothesis The internet based interventions will be more effective at reducing symptoms of     depression in pregnant women than treatment as usual, in terms of rates of diagnoses and     levels of self rated symptoms of depression.   "
105197|NCT01909154|"     The purpose of this study is to confirm the security, and detect the effect of the local     administration in damaged nervous tissue, of autologous bone marrow stromal cells.   "
105222|NCT01908829|"     The purpose of this study is to see if adding a new type of medication recently approved to     treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) will be     more effective in controlling incontinence than when using the antimuscarinic treatment     alone.   "
105200|NCT01909115|"     Vitamin D deficiency is common in the general population and more common in children with     chronic kidney disease. Vitamin D is very important for bone health, especially in children     with chronic kidney disease. To date, several studies using different doses of vitamin D have     been tried to correct vitamin D deficiency, but none has been completely successful. The     investigators are comparing two different doses of vitamin D to determine which one is more     effective at correcting and maintaining normal blood levels of vitamin D. The investigators     hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be     vitamin D replete at the end of 6 months.      This study will enroll 80 children 9 to 18 years old who have chronic kidney disease and can     take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis     Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.      After the investigators obtain informed consent and assent, children will be randomly     assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D     pills (50% in each group). Patients will be in this study for 6 months. They will take     vitamin D pills for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6     months. The study visits will be at the same time as routine clinic visits when the children     are having blood drawn for routine care. At the end of the study, the investigators will     compare the percentage of patients who have normal vitamin D levels at 6 months in the two     groups. The investigators will also describe the percentage of patients who have elevated or     low levels of trace elements.      The two doses of vitamin D in this study are within the dosing range recommended by the     Institute of Medicine, and thus the investigators do not anticipate any adverse effects.     Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months     would be an indication to withdraw a patient from the study.   "
105201|NCT01909102|"     The study will determine whether a brief intervention program based on Acceptance and     Commitment Therapy can be effective for the reduction of modifiable risk factors and     improvement of psychological well-being in patients referred to cardiac rehabilitation   "
105202|NCT01909089|"     Combined spinal-epidural (CSE) analgesia has become a widely accepted approach to provide     analgesia for labour pain. Despite the increasingly widespread use of this technique, an     optimal intrathecal drug regimen has not been established yet.      Several investigations using local anesthetics such as Bupivacaine, Levobupivacaine and     Ropivacaine in CSE during labour have been published. But despite the reintroduction of     Chloroprocaine recently there haven't been any investigations about spinal chloroprocaine.     Chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic profile.     It is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid metabolism     by plasma cholinesterases and short half-life both in mother and fetus.      Because of this beneficial profile, Chloroprocaine is widely used intrathecally for surgical     anesthesia. Several investigations demonstrate that for surgical anesthesia doses     Chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical     duration of 40 - 90 minutes.      Despite these standards for surgical anesthesia, little is known about spinal     Chloroprocaine dose regimens. Therefore the primary goal of this study is to determine the     minimum adequate dose of Chloroprocaine that is to be given spinally to a woman in labour     using a CSE procedure. We will use the up-down sequential allocation to identify the median     effective dose (ED50) or concentration (EC50).      The Effective dose in 95% of the population (ED95) can be estimated also from an up-down     sequential allocation and will become an important valuable approximation of the clinical     dose.   "
105203|NCT01909076|"     Prescription opioid misuse is a significant public health problem as well as a patient safety     concern. Primary care providers are the leading prescribers of opioids for chronic pain, yet     few providers follow standard practice guidelines regarding assessment and monitoring. The     investigators propose a novel system change in delivery of primary care services to decrease     misuse of and addiction to prescription opioids for patients with chronic pain.      The proposed intervention for the overall project includes a nurse-managed registry for     planning individual patient care and conducting population-based care for a population of     patients receiving opioids for chronic pain. Academic detailing to clinicians is another     effective way to improve care. Finally, the researchers will create a knowledge management     tool to facilitate guideline adherence. This tool will be accessible via an internet link,     and will include validated instruments to assess patient status and also to facilitate     physician adherence to suggested monitoring.   "
105204|NCT01909063|"     The goal of this investigator-initiated study is to determine whether the fortification of     orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A,     and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston     University Medical Center. Circulating concentrations of 25-hydroxyvitamin D [25(OH)D],     vitamin A, and vitamin E before, will be measured at mid-intervention (week 6), and after a     period of twelve weeks. This study plans to recruit 180 male and female subjects between the     ages of 6 and 10. An informed consent will be explained and discussed with the subjects and     their parents/guardians willing to participate in the study. The study will be twelve weeks.     Blood will be drawn during the initial visit, mid-intervention (week 6), and week 12. Dietary     intake will be assessed at baseline and at the conclusion of the 12-week intervention using a     3-day food record. The subjects will be randomized in a double-blinded manner via an     electronically shuffled listed. Subjects will be randomized to receive one of three     beverages: (1) calcium plus vitamin D fortified orange juice (intervention A), (2) calcium     plus vitamins D, A, and E fortified orange juice (intervention B) or (3) calcium-only     fortified orange juice (controls). Subjects in all groups will drink two 8-oz. glasses of     juice at least six hours apart (morning and afternoon) per day for a period of 12 weeks.     Subjects randomized to intervention A will receive 200 IU vitamin D and 700 mg of calcium per     day in 2 glasses of juice, intervention B will receive 200 IU vitamin D, 12 IU vitamin E,     2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice,     while controls will receive 700 mg of calcium per day in 2 glasses of juice. A blood sample     will be obtained before the subjects begin drinking the orange juice and at week 12 to     determine levels of 25(OH)D which is a measure of vitamin D status. Blood will also be used     for determining osteocalcin, parathyroid hormone (PTH), alkaline phosphatase, phosphorus,     calcium, C-telopeptide (CTX), albumin, vitamin A, and vitamin E. A blood sample will also be     obtained at week 6 for 25(OH)D and PTH.   "
105205|NCT01909050|"     The main purpose of this study is to see how cells taken from the lining of the intestine     behave in the laboratory with exposure to gluten and other substances that act on the immune     system. The cells lining the intestine of a person with celiac disease should be different     than a person without celiac disease. The study doctors would like to see how the cells react     after coming in contact with gluten and if substances that act on the immune system can     prevent gluten related inflammation. Examples of these substances include steroids. The cells     should produce chemicals of their own in response to the gluten. These other chemicals will     be measured and the results compared between those with:        -  celiac disease that does not respond to a gluten-free diet (refractory celiac disease)        -  celiac disease which is controlled by a gluten-free diet        -  uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a          gluten-free diet        -  gluten-sensitivity        -  disorders other than celiac disease.   "
105206|NCT01909037|"     The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol)     during a 90-days period in knee ostearthritis patients on the serum levels of specific     biomarkers of osteoarthritis and on the evaluation of pain.   "
105207|NCT01909024|"     The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic     embolisation) in females with recurrent leg varicose veins, who have a proven contribution to     their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence     after endovenous laser treatment for recurrent varicose veins in the legs.   "
105208|NCT01909011|"     The purpose of this study is to assess the antidepressant effects of Cranial Electrotherapy     Stimulation (CES) in the depressed phase of bipolar II disorder.; to examine the safety of     daily CES in bipolar II patients; and to examine the effects of 20 minutes of daily CES on     EEG reading.      The investigators hypothesize:        1. The CES will reduce symptom severity more than sham (placebo) CES.        2. That CES administered for 20 minutes daily for four weeks is safe and well tolerated          when treating bipolar II patients.        3. That CES will shift the alpha and beta power fractions of EEG downward, and that this          shift correlates with a decrease in level of anxiety and depression   "
105209|NCT01908998|"     The Y-balance test is a lower extremity, dynamic test performed in single limb stance that     measures a person's ability to reach in 3 directions. The test is typically conducted in     barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test     scores. The investigators hypothesize that by improving alignment and augmenting muscle     mechanics, sandals with medial arch support may improve Y-Balance scores.   "
105210|NCT01908985|"     Monocentric prospective study conducted in two phases evaluating the secretion and     elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with     cyclo-coagulation with ultrasound.      Population selected:      - Patients with refractory open angle glaucoma despite previous treatments currently     validated for glaucoma.      The purpose of our study is:      - To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high     intensity focused ultrasound in studying the secretion and elimination of aqueous humor by     fluorophotometry.      Planning:        -  First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of          aqueous humor production at one month in the first two patients in the feasibility          study, further in second phase.        -  Second phase: 6 patients   "
105211|NCT01908972|"     The purpose of this study is to determine the safety and efficiency of Propranolol as an     initial treatment for pediatric hemangioma.   "
105212|NCT01908959|"     The purpose of Madres Para la Salud [Mothers for Their Health] is to see how support and     encouragement can help women to make positive changes in their health. This program tested if     supportive information, encouragement, and walking as a group would increase physical     activity and health benefits, such as weight loss and postpartum depression.      Participants in this study were randomly assigned to one of two groups, a walking or a     non-walking group. The walking group met weekly. Participants were given a pedometer to     record the number of steps taken daily.      Participants met one time each week with our study staff. Participants walked four other days     per week on their own, or with other group members. Participants measurements included body     fat, waist, and hip at the beginning of the study, and at 3, 6, 9, and 12 months. The     non-walking group received a weekly mailed newsletter about topics such as parenting, infant     growth and development, and reproductive health. Non-walking group participants' measurements     included body fat, waist, and hip at the beginning of the study and at 6 and 12 months.   "
105213|NCT01908946|"     The investigators plan to test the effectiveness of reminders to parents/guardians on cell     phones through short messaging system (SMS) in improving the on-time routine immunization for     children in Pakistan. SMS message as a reminder tool can be very effective in health care     settings at public health scale. This study will be conducted in an urban- squatter     settlement area, Ibrahim Haidry union council in Karachi. Parents/guardians of children     randomized in intervention arm will be sent SMS reminders vaccination visit reminders at 6,     10 and 14 weeks of life.   "
105214|NCT01908933|"     The purpose of this study is to prospectively evaluate the safety and efficacy of the     AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.   "
105215|NCT01908920|"     The aim of the present study is to determine the extend to which osteopathic manipulative     treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF)     parameters.   "
105216|NCT01908907|"     The purpose of this study is to understand if the DHA gap can be corrected by giving a     daily dose of DHA oil to preterm babies.      DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take     it in through our diet. DHA is important for normal brain and eye health and it may also     decrease inflammation. This is important for premature babies because they are at a greater     risk for getting diseases related to inflammation, especially in their lungs, eyes and     intestines. Since DHA is so important for normal growth, you will find DHA naturally in     breast milk and it is now added to infant formula. But the amount in breast milk and infant     formula is about half of what your infant should expect to get in the womb (about 13-29mg per     day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even     greater disadvantage because they cannot always eat very much right away and that is the only     way they can get essential fatty acids in their body. This means premature babies are getting     less DHA than they would in the womb and then the DHA gap continues for a longer period of     time. This gap also comes at a time when their brain is growing most rapidly and their bodies     need it the most. This trial is designed to see if giving DHA, even before the baby can take     food orally, will raise his/her DHA blood levels to those of normal term babies.   "
105217|NCT01908894|"     The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and     compare them to Humalog.   "
105218|NCT01908881|"     The purpose of this study is to determine whether a group intervention for primary health     care dyads (two interacting people, in this case: mother-infant or caregiver-infant), which     have been screened during pregnancy to be at psychosocial risk, has an impact on parental     sensitivity.   "
105219|NCT01908868|"     The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in     diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial     lung biopsy.   "
105220|NCT01908855|"     The purpose of this study is to evaluate whether cognitive-behavioral therapy enriched with     strategies from emotion regulation training leads to better improvement in somatic symptoms     and comorbid problems than cognitive-behavioral therapy alone.   "
105221|NCT01908842|"     The purpose of this study was to assess retention in treatment after induction with     buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after     stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives     included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and     safety.   "
105232|NCT01908699|"     This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess     the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in     patients with pulmonary arterial hypertension.      Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of     experience is achieved to ensure drug tolerability before enrolling in the study.      Treatment groups consist of one active and one placebo group. Subjects will be randomly     allocated in a 1:1 ratio to one of the two treatment groups.   "
105233|NCT01908686|"     The purpose of this study is to evaluate the application of an evidence-based, manualized     treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT)     to children ages four through six years of age with ASD. Specifically, children will be     randomly assigned to receive either (1) 10 hours per week of intervention services, including     two hours per week of parent education, and eight hours per week of direct     clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on     enhancing the following developmental skills: expressive and receptive language, play, and     social interaction. Outcome measures will address changes in the aforementioned domains     during structured observation and standardized assessment.   "
105234|NCT01908673|"     Background: Depression in the elderly, also known as late life depression (LLD) is common and     its prevalence ranges from 2 to 6% in the community. Heart Rate Variability (HRV), a     physiological autonomic variable is reduced in LLD and this might have implications for     cardiovascular events including death. Methods to improve HRV in LLD have not been adequately     assessed. Automatic Self-Transcending Meditation (ASTM) is a simple yet powerful technique     that allows the mind to become calm and peaceful. HRV biofeedback is a method of teaching     individuals to voluntarily improve HRV and other physiological functions to a prescribed     range.This pilot study attempts to investigate feasibility of these interventions and provide     preliminary data regarding the effectiveness of these techniques.      Hypothesis: ASTM and HRV biofeedback are feasible and their effectiveness for improving HRV     in patients with LLD can be assessed.      Methods: Participants with LLD between the ages of 66 and 80 will be randomized to either     ASTM or HRV biofeedback after optimizing them on antidepressant therapy. Participants will     receive training and continue practice in either of these techniques over a period of twelve     weeks. HRV and secondary measures will be assessed pre and post at the end of study period.      Expected Results and Significance: The investigators expect to find both techniques to be     feasible treatments for those with LLD. Results from this pilot study will help to assess the     potential for successful implementation of a future larger study which will evaluate the     efficacy of these treatments for improving HRV.   "
105235|NCT01908660|"     The purpose of this study is to compare the liver toxicity in HIV-infected patients with     chronic hepatitis B and/or hepatitis C, who start a new antiretroviral drug regimen, as well     as the influence of the degree of pre-existing liver fibrosis on the incidence of liver     toxicity.   "
105236|NCT01908647|"     In this randomized, controlled clinical trial, we will evaluate the effects of (1) a     brain-training program that uses real-time neurofeedback in functional magnetic resonance     imaging (fMRI) to allow people to learn how to gain voluntary control over activity in     targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a     software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training     tasks on cognitive learning and symptoms. In addition, the investigators will measure brain     function (active and resting functional magnetic resonance imaging) and structure (high     resolution magnetic resonance imaging) before and after treatment.   "
105237|NCT01908634|"     Primary objective is to evaluate the influence of matrix on the bioavailability of key     phytochemical constituents in fruits and their subsequent effect on chronic disease risk     factors.   "
105238|NCT01908621|"     The purpose of the study is to compare safety and efficacy of stem cell mobilization using     G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple     myeloma patients.   "
105239|NCT01908595|"     This study is to evaluate the efficacy and safety for long term use of M518101 in subjects     with plaque psoriasis.   "
105240|NCT01908582|"     The main purpose of this study is to determine how much evacetrapib gets into the blood     stream and how long it takes the body to get rid of it when given with rifampin. The safety     and tolerability of the two drugs, given together, will also be evaluated. The study will     also look at blood cholesterol levels and levels of a hormone called cortisol before and     after taking rifampin. Information about any side effects that may occur will also be     collected.      For each participant, this study will include 2 periods in fixed order. The study will last     approximately 29 days.   "
105241|NCT01908569|"     The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads,     magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin     V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us     to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine     residues on their membrane surface. Using this technique, the apoptotic spermatozoids will     join the microbeads and consequently be retained in a column applying a magnetic field.      Recent studies show the benefits of spermatozoid selection using MACS and the improvement in     mobility, viability, DNA fragmentation and fertilization potential. It has also been observed     an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid     survival after thawing. However, it is necessary to perform new clinical studies in order to     evaluate the real potential of this technology and its safety.      The purpose of this study is to evaluate the effect of the MACS technique on the clinical     results of good-prognosis patients who are going through IVF/ICSI treatments in order to     achieve a pregnancy.      The hypothesis of this study is that the application of the MACS technique in assisted     reproduction treatments is associated with a better embryo quality and pregnancy rates.   "
105304|NCT01907750|"     To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not     transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.   "
131860|NCT01559064|"     This is a prospective, observational study of the volumizing effect of aesthetic use of     Juvéderm VOLUMA® with lidocaine in the mid-face area.   "
106263|NCT01895127|"     This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and     Immunoglobulin (IVIg) for the treatment of AMR in renal transplant recipients. All patients     will be evaluated from the time of AMR diagnosis for 12 months.   "
105242|NCT01908556|"     Aromatase inhibitors have shown a superior efficacy compared to tamoxifen in the treatment of     hormonal receptor positive breast cancer in postmenopausal patients.      Side effects like osteoporosis, bone fractures and muscle/bone pain are however more frequent     using of aromatase inhibitors compared with tamoxifen. These side effects compromise the     patients' well being in a significant way and may favour the use of Tamoxifen in clinical     practice.      Furthermore there is evidence that polymorphisms in the CYP2D6 Gene might be associated with     an improved efficacy of Tamoxifen that is equieffective to aromatase inhibitors.      Concerning the pharmacogenetics of aromatase inhibition there are known polymorphisms of the     CYP19A1 gene that are associated with altered peripheral sex hormone levels and altered     prognosis in breast cancer patients. One study could even associate a polymorphism in the     CYP19A1 gene with a prolonged time to progression in patients with metastatic breast cancer     who have been treated with letrozol.      Therefore the aim of this study is to identify biomarkers that could predict the efficacy of     an adjuvant Letrozol treatment in postmenopausal breast cancer patients.   "
105243|NCT01908543|"     Managing iron deficiency is important for more than 1 billion individuals worldwide, to avoid     blood transfusions, or excessive strain on vital organs that depend on iron-containing     haemoglobin to deliver oxygen to the tissues. Iron deficiency is a particular problem for     people with the inherited condition hereditary haemorrhagic telangiectasia (HHT). Their iron     deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and     they often need additional iron to replace that lost through bleeding.      Our goal is to stratify HHT patients into high/low absorbers of iron; to define what extra     iron they need to adjust for their current and likely future blood losses; and to work out     how to achieve this most safely for each individual to improve their later health.      We will test the hypothesis that informed assessment of iron intake and post absorption     cellular profiles changes the recommendations for iron intake for HHT patients.   "
105244|NCT01908530|"     The purpose of the study is to assess the safety and efficacy of the Imperial College     Microprobe Array Continuous Glucose Sensor in healthy volunteers and in subjects with type 1     diabetes.   "
105245|NCT01908517|"     There has been very limited research that has looked at electronic reminders (text messages)     and its effectiveness in adherence to vaccination among low-income minority populations.     Results have shown that text messages, among low-income parents and adolescents who were     identified as having a cellphone, is an effective strategy to increase the likelihood of     adolescent vaccination adherence. Hard copy and electronic messaging reminders have also been     proven to be effective when coupled with other prevention strategies for immunizations for     influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in     adults. Additionally, Merck and Co. recommend electronic reminders in their patient     compliance program as a key strategy for adherence. To our knowledge, this community-based     pilot intervention study will be the first to assess electronic reminders and HPV vaccine     initiation and adherence among rural uninsured and Medicaid populations. The investigators     hypothesize that adolescent whose parents who receive the intervention will be more likely to     initiate HPV vaccination and be compliant at 3 months and at 7 months as compared to the     control group.   "
105246|NCT01908504|"     The purpose of this study is to determine the benefit of using positron emission tomography     (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for     cancer treatment. The information from the PET-CT may allow the investigators to change the     radiation plan or the delivery of the radiation to the tumor/tumor site such as the total     dose of radiation or the size of the area to receive further radiation. Presently the use of     PET scans to adjust radiation therapy during radiation treatment is not standard of care and     is being investigated in this study.   "
105247|NCT01908491|"     Postoperative pain management is a major problem after repair of pectus excavatum.Various     methods of pain management have been introduced. However, the effects of continuous wound     infusion of local anesthetics through ON-Q catheters were not well evaluated in pectus     surgery. Therefore, we conducted prospective randomized controlled study to compare the     effects of IV PCA and continuous wound infusion after repair of pectus excavatum.   "
105248|NCT01908478|"     This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity     Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic     Cancer.      Primary Objectives:        -  Determine the maximum tolerable dose of veliparib in combination with gemcitabine and          intensity modulated radiation therapy in patients with locally advanced pancreatic          cancer.        -  Determine the safety and toxicity of the combination of veliparib with gemcitabine and          radiation therapy in patients with locally advanced pancreatic cancer   "
105249|NCT01908465|"     Purpose:      To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the     H1-receptor antagonist ebastine.      Design:      Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment     with ebastine 20mg once daily or placebo (1:1 randomization).   "
105250|NCT01908452|"     Objectives: The mechanisms of tardive dyskinesia (TD) remain unclear, although     pathophysiologic theories have proposed mechanisms such as dopamine receptor     supersensitivity, the degeneration of cholinergic striatal interneurons, γ-aminobutyric acid     (GABA) depletion, and an excess of free radicals.      Prior development of second generation antipsychotic agents, tardive movement disorders were     widespread among neuroleptics treated patients. There were great expectations of the new     novel drugs. Unfortunately, reports about tardive movement disturbances induced by these     medications became more and more frequent, although it has been in use for less than two     decades.      A recent study demonstrated that schizophrenic and schizoaffective patients suffering from TD     had the mean level of pyridoxal 5'-phosphate (PLP) below lower limit of normal range, while     those patients without TD had normal values. At the same time, some open and double-blind     placebo-controlled, randomized clinical studies showed that vitamin B6 was very effective in     treatment of TD.      Pyridoxal kinase is a key enzyme for the biosynthesis of PLP, the biologically active form of     vitamin B6. Some publications reported that the finding of high vitamin B6 levels is     consistent with recent reports of low levels of PLP and low activity of pyridoxal kinase. It     may explain the functional need for high-dose vitamin B6 supplementation in subjects with TD.      Methods: A multicenter study including 300 schizophrenia and schizoaffective subjects will be     performed. The trial will be consisted of 2 parts: the first part a single comparison     pyridoxal kinase plasma activity in patients with and without TD; in the second part only TD     schizophrenia and schizoaffective patients will continue. It will be a 12-week, randomized,     double-blind placebo-controlled trial. Vitamin B6 (1200 mg/day) or placebo capsules will be     added to the stable ongoing antipsychotic treatment of 150 schizophrenia patients.     Participants will be assessed at baseline and after every 2 weeks of treatment till week 12.     Pyridoxal kinase activity will be compared between patients who positively respond to vitamin     B6 versus non responders. In addition, PLP levels will be monitored at baseline and at the     end of the study.      A battery of research tools will be used for assessment of movement disorders,     psychopathology, and side effects. The study will be performed along a period of 2 years.   "
105251|NCT01908439|"     The purpose of this study was to examine the validity of the measurement method based on     observation of vibration stimulation-MUAP (motor unit action potential) (1 to 1) matching     that helps to measure human WBV-induced muscular reflex latency and to compare these results     with the latency determination obtained using the classical methods. The investigators'     principle hypothesis is that the simple method is capable of determining the WBV induced     reflex response latency as reliably as the complex methods described earlier.      To achieve this goal, the investigators have averaged the electrical responses of the soleus     muscle (sEMG and multi motor unit (MMU) potential) against the vertical force data obtained     during all the six vibration frequencies tested in this study. The investigators have then     combined all the averaged EMG data belonging to six different vibration frequencies to     generate the 'cumulative averaged' sEMG and MMU for each subject. The investigators have also     obtained the standard error for the cumulative averaged records which indicated the     WBV-induced muscular reflex (WBV-IMR) latency.   "
105252|NCT01908426|"     The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with     placebo on overall survival in subjects with advanced hepatocellular carcinoma who have     received prior sorafenib.   "
105253|NCT01908413|"     This is a phase I, open-label, dose-escalation study of CUDC-427 in patients with advanced or     refractory solid tumors or lymphoma. CUDC-427 is a drug that is designed to antagonize     proteins that prevent or interfere with cell death. The study is designed to assess the     safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-cancer     activity of CUDC-427.   "
105254|NCT01908400|"     Mental retardation is a condition diagnosed before age 18 that includes below-average general     intellectual function, and a lack of the skills necessary for daily living. Mental     retardation affects about 1 - 3% of the population. There are many causes of mental     retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells     are used in this condition to prove its safety and efficacy .   "
105255|NCT01908387|"     To identify the maximum tolerated dose (MTD) of oral azacitidine on different treatment     schedules in Japanese subjects with hematological neoplasms   "
105256|NCT01908374|"     The primary objective of this study is to test the effects of two different fish oil products     containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.   "
105257|NCT01908361|"     In the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate     clinical trials: one to recruit subacute stroke patients and another to recruit chronic     stroke patients. The two trials will have identical study designs and interventions. The     overall goal of this research project is to provide scientific evidence of the treatment     effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients     and thus to contribute to evidence-based stroke rehabilitation and translational research for     neurorehabilitation.   "
105258|NCT01908348|"     This study is an open-label pilot designed to examine the dose-dependent effects of     erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type     2 diabetes mellitus will make three study visits. At each visit, the will consume an     orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams).     Endothelial function will be assessed before and two hours after beverage consumption.     Endothelial function will be measured as the change in pulse amplitude in response to     reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results     will be used to plan a randomized, placebo-controlled study.   "
105259|NCT01908335|"     This dose-escalating study is to evaluate the efficacy and the safety of different doses of a     new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection     (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been     previously treated with Interferon(IFN) by exploring the dose-effect relationship, while     identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method     is adopted to assess the pharmacokinetic behavior, individuals / intra-individual     variability, and the possible factors for further study.   "
105260|NCT01908322|"     The study aims to investigate patient characteristics of intermediate stage hepatocellular     carcinoma patients treated with Nexavar and their distribution to different treatment groups     as well as determining efficacy and safety parameters.   "
105261|NCT01908309|"     We previously demonstrated that the slope of the relationship plotting individual iodine     loads against contrast-induced serum creatinine changes ( the load-to-damage relationship,     LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is     to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two     different contrast media using serum cystatin-C changes as the LDR dependent variable.   "
105262|NCT01908296|"     The objective of the study was to assess the effect of multiple-dose fluvoxamine on the     pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E     in the population was also evaluated.   "
105263|NCT01908283|"     Patients with inflammatory bowel disease are at increased risk for infections due to their     baseline disease and the subsequent immunocompromising regimen. Streptococcus pneumoniae     (pneumococcus) has a high mortality and morbidity, particularly in immunosuppressed patients.     A polysaccharide vaccine covering 23 different serotypes of pneumococcus (PPSV23) is     currently recommended to immunocompromised patients to reduce their risk of invasive     pneumococcal infections (such as bacteremia, meningitis, or pneumonia). Its immunogenicity is     however limited, both in magnitude and duration, even in healthy individuals. Several studies     have investigated the immunogenicity of PPSV23 in patients with IBD and have reported a     marked inhibitory effect of immunosuppressive therapy on vaccine responses.      A pneumococcal conjugated vaccine (PCV) was originally developed to protect young children     and demonstrated as highly effective and safe. PCV13 contains polysaccharides from thirteen     different serotypes, conjugated to an inactivated diphtheria toxin, and has the capacity to     induce both primary and memory responses. PCV also appears much more immunogenic than PPSV23     in immunocompromised pediatric and adult patients. Whether some therapeutic regimens may     nevertheless prevent the induction of protective responses by PCV13 is yet unknown.      To date, no study has yet reported the immunogenicity / safety of PCV13 in adult IBD     patients.      Study's objectives        -  Primary objective: evaluate the immunogenicity and safety profile of PCV13 immunization          in IBD patients        -  Secondary objective: evaluate the relative influence of treatment and disease on immune          responses to PCV13 immunization        -  Tertiary objective: evaluate the immunity/vulnerability against vaccine-preventable          diseases (VZV, measles) in the IBD cohort of Switzerland (optional, depending on funds)   "
105349|NCT01907165|"     This clinical trial studies disulfiram in treating patients with glioblastoma multiforme     (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of     the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients.   "
105264|NCT01908270|"     Women with breast cancer and breast cancer survivors are often bothered by menopausal     symptoms to a special degree. Treatment options for those symptoms are currently limited as     hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal     symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to     investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with     breast cancer and breast cancer survivors.   "
105265|NCT01908257|"     This is a drug-drug interaction study in healthy volunteers to evaluate the potential     pharmacokinetic (PK) effects of ranitidine on lesinurad.   "
105266|NCT01908244|"     The purpose of this study is to determine the effects of pentatonic live music on     physiological parameters in preterm infants.   "
105267|NCT01908231|"     To prospectively investigate the association between plasma lactate concentration and     short-term adverse outcomes in patients with acute PE.   "
105268|NCT01908218|"     Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper     management.      Several methods to evaluate the anatomical structures has been used during preoperative     period for airway assessment.      Evaluation methods are such as the Mallampati classification, mouth opening, thyromental     distance and sternocostal distance.      the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper     lip by the lower incisor.      The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT)     in Korean compared to Modified Mallampati classification(MMT).   "
105269|NCT01908205|"     We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon®     has been approved by the U.S. Food and Drug Administration for use in helping women     breastfeed, but it has not been approved for use in children with ASD. However, there is     previous research conducted that has indicated that after administration of oxytocin, adults     with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and     anxiety. There is also early research to suggest that children may also benefit in these     areas. The purpose of this study is to test if oxytocin works to help children and     adolescents with ASD.   "
105270|NCT01908192|"     The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment     for schizophrenia in adolescents.   "
105271|NCT01908179|"     This registry study will evaluate patients with metastatic brain tumors undergoing, or having     undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will     be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and     imaging data (including anatomic and advanced imaging sequences obtained prior to and     serially following SRS) will be archived in an online informatics platform, specifically a     metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for     Metastatic Tumors (CONDR - Mets).   "
105272|NCT01908166|"     This clinical trial studies ultrasound elastography in diagnosing patients with kidney or     liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be     a less invasive way to check for kidney or liver solid focal lesions.   "
105273|NCT01908153|"     The study aims to provide a better understanding of the neural influence of eating behavior     in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI     brain response to pictures that signal delivery of a chocolate milkshake and to the taste     itself. The brain response will be compared to body mass index percentile scores for each     child to help us determine whether brain differences present in adolescents and adults with     obesity are present in young children.   "
105274|NCT01908140|"     The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium     bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic     obstructive pulmonary disease (COPD)   "
105275|NCT01908127|"     The aim of this study is to evaluate the effect of Filmed modelling in comparison with     commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years     old children during dental practice.   "
105276|NCT01908114|"     The objective of the projects is to Develop and implement a Package of interventions that     will comprise of an augmented communication and counseling strategy coupled with private     sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach     during the Polio campaigns followed by the evaluation of this project for acceptability,     feasibility and effectiveness of the intervention Package.   "
105277|NCT01908101|"     This phase II trial studies how well eribulin mesylate works in treating patients with     previously treated breast cancer that has spread to other places in the body. Drugs used in     chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading.   "
105278|NCT01908088|"     Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring     fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either     autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is     severe with some morbidity such as mitten hand deformity.      The management of these patients is very difficult because no effective treatment has been     known yet.      The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas     of hand which is without the skin. In this study the investigators assess the safety of     autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for     them.   "
105279|NCT01908075|"     To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at     least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol     (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment     with FP/SAL in normal clinical practice compared with patients not switched.   "
105280|NCT01908062|"     The purpose of this study is to learn how best to treat substance use disorders in an HIV     clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release     naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals     with opioid or alcohol use disorders.   "
105350|NCT01907152|"     The objective of this study is to investigate the acceptance, intake, and compliance of     protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real     life settings (short term; hospital, and longer term; rehabilitation home).   "
105281|NCT01908049|"     Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with     probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution     and the changes in gut microbiota composition.      SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the     administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV     viral load in patients after taking probiotics.      Methods: Design: A prospective randomized open controlled double-blinded trial, to be     performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients.     Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells /     ml and undetectable viral load for more than two years (22 cases) and (2) Patients with     immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite     4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were     randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii     for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels     measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma     (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota     composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and     clinical data. Outcome measures: quantification of bacterial translocation levels, markers of     activity and immune recovery. Analysis: Comparison of variables before and after the     intervention. The analysis will be performed by biological and immunological effectiveness.   "
105282|NCT01908036|"     The use of an activity monitor to determine increase or decrease of activity in patients     suffering from chronic fatigue syndrome.   "
105283|NCT01908023|"     Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of     short-and long-term side effects may be experienced, such as physical deterioration, reduced     quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all     out-patients undergoing post operative radiotherapy are currently offered participation in     group exercise training sessions. The main purpose of this study is to evaluate these     out-patient group exercise sessions.   "
105284|NCT01908010|"     This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20     male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's     disease on stable doses of acetylcholinesterase inhibitors.   "
105285|NCT01907997|"     Systemic lidocaine infusion may improve the patients' recovery quality and chronic post     surgical pain after robot-assisted thyroidectomy   "
105286|NCT01907984|"     Purpose:      According to the proposal of the International Headache Society acute postcraniotomy headache     (PCH) is defined as a headache of variable intensity, being most serious at the site of     surgical intervention and developing within 7 days after craniotomy. Typically, pain resolves     within 3 months after surgery. According to the literature the incidence of acute PCH during     the postoperative period is 60% among patients undergoing elective craniotomies. No     standardized international guidelines are available on the treatment of PCH to the present     day. Treatment methods can be different based on the country and institution where they are     used, or even physicians individually can have distinct medication regime, which sometimes     happens to be habitual and lacks clinical evidences.      The Department of Anesthesiology and Intensive Care Medicine at the University of Debrecen     has been giving 100 mg diclofenac with analgesic purpose, as part of the premedication to     neurosurgical patients for several years. It was observed that the postoperative headache     following craniotomy was milder comparing to data published in the international literature.     A pilot study was carried out with similar settings which found the that incidence of PCH was     lower and less analgesics were required without any further unwanted side-effects among     patients who received 100 mg diclofenac as part of the premedication.      Hypothesis:      100 mg preoperatively given diclofenac significantly reduces the incidence and severity of     postcraniotomy headache.   "
105287|NCT01907971|"     Ebstein anomaly is a rare congenital heart disease. It encompasses abnormalities of the     tricuspid valve, the right atrium and the right ventricle (RV).      Currently, cardiac magnetic resonance imaging (MRI) is considered the method of choice for     the assessment of RV volume and function. To evaluate the right heart function VentriPoint     method was designed to assess the RV in a fraction of the time, resulting in better efficacy     and lower costs. VentriPoint is approved for Tetralogy of Fallot patients as well as patients     with systemic RV in d-transposition of the great arteries. This method uses 2 dimensional     standard ultrasound views linked to a VentriPoint Medical Systems unit. After acquisition,     the physician identifies anatomical landmarks with dots on a number of the 2D ultrasound     views through the heart. With a sensor (magnetic tracking system: GPS) on the ultrasound     probe we know where the 2D plane is in 3D space. In this way the precise anatomical landmark     is located in 3D space.      The aim of the present study is to assess the feasibility, reliability and accuracy of the     echocardiographic knowledge-based 3D reconstruction method to measure RV volume and function     in patients with Ebstein anomaly. The accuracy of the method will be assessed by comparison     with measurements obtained by cardiac MRI.      In addition to the right ventricle the investigators want to assess the left ventricular     function in patients with Ebstein anomaly in this study. By using speckle tracking     echocardiography the investigators would like to investigate on the left ventricular     contractility, rotation and synchrony of the left ventricle together with the RV. Not seldom     the left ventricle is neglected in a patient with Ebstein anomaly by impressive findings of     the right ventricle. Changes in the myocardial left ventricular structure (non compaction)     are also described and may have negative impact on the function.      The investigators want to analyze 25-30 patients with Ebstein anomaly including children     starting at 11 years of age.   "
105288|NCT01907958|"     Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and     Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin     to usual practice on quality of care in hypertensive patients with Type 2 diabetes.   "
105289|NCT01907945|"     This study is a non-randomized double cohort study evaluating the impact of social     network-based water treatment education on sustained household water treatment behaviors over     12 months of follow up. A three-session curriculum was developed on the spread of water borne     illness, water treatment methods, and the role of social support in water treatment.     Participants in the intervention arm will receive this curriculum in a group setting, where     group members are self-selected members of the study participants' social networks.     Participants in the comparison arm will receive the same curriculum taught at the individual     household level. All participants will receive CeraMaji ceramic filters for use in household     water treatment after participating in the three sessions. Research staff will conduct     surveys and water quality testing over a period of 12 months to determine whether     participants continue to use the ceramic filters. Investigators hypothesize that social     network-based training on household water treatment will result in a higher proportion of     households using ceramic filters at 6- and 12-months as compared to households receiving     individual training.   "
105290|NCT01907932|"     In internal medicine, assessment of spleen size on physical examination is an extremely     important part of the overall evaluation of patients with many illnesses. Examination of the     spleen is also one of the core competencies that the investigators expect the students and     residents to learn as part of their training. Unfortunately, the sensitivity and specificity     of examination of the spleen at the bedside is not very good. The investigators wish to     determine if medical residents can be taught to use hand carried ultrasound to accurately     assess spleen size. Doing so would make physical examination of the spleen obsolete and     transform training objectives for medical trainees.   "
105291|NCT01907919|"     The purpose of this study was to compare the conventional and diode 808 nm laser-assisted     techniques in direct pulp capping in permanent teeth .The present study was based on a series     of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis of this     paper was laser supported direct pulp cap-ping has proven effectiveness by its capacity to     stimulate reparative dentine formation by pulp cells, de-contamination ability of irradiated     areas, its ability in the fast and better haemostatic, and pain reduction.   "
105292|NCT01907906|"     The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red     blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as     leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects   "
105293|NCT01907893|"     The study uses a multi-site, cluster design to determine the effectiveness of an intervention     based on a Trauma Collaborative Care (TCC) model in improving patient outcomes for persons     with severe orthopedic trauma and enhancing both patient and provider satisfaction with     overall care. The study will also determine the cost and cost-effectiveness of the     intervention.      Primary Hypothesis: Compared to standard treatment alone, access to the TCC Program plus     standard treatment will result in lower rates of the composite outcome (i.e. positive for     poor function, depression, and/or PTSD).      Secondary Hypotheses: Compared to standard treatment alone, access to the TCC Program plus     standard treatment will result in lower levels of pain and higher rates of return to usual     major activity and higher levels of health related quality of life. In addition, both primary     and secondary outcomes will correlate strongly with the intermediate outcome of     self-efficacy.   "
105294|NCT01907880|"     Metastatic breast cancer patients with bone involvement who are at high-risk of subsequent     skeletal related event (SRE), defined as radiotherapy or surgery to the bone, pathological     fracture, spinal cord compression, or hypercalcemia (as reflected through: elevated sCTX or     bone pain or a prior SRE despite receiving standard bisphosphonate therapy) should experience     a decrease in the surrogate marker, sCTX, at week 12 if switched to zoledronic acid compared     with those patients who continue on intravenous pamidronate (i.e. current standard of care).     The investigators propose that a drop in sCTX will correlate with improved pain, quality of     life and a reduced incidence of further SREs.   "
105295|NCT01907867|"     This study investigates the safety, tolerability, and PK profile of finafloxacin as a novel     fluoroquinolone and a potential therapeutic agent for lower respiratory infections such as     bacterial pneumonia. A comparison of the PK profile of finafloxacin in plasma and lung ELF     using different bronchoscopic ELF sampling techniques (BMS and BAL) is conducted.   "
105296|NCT01907854|"     This trial is conducted in Asia, Europe and North America. The aim of the trial is to     investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects     with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.   "
105297|NCT01907841|"     Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle     damage and changes in muscle function; this is known as exercise-induced muscle damage     (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known     as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as     in various other organs.      Therefore the purpose of this study is to:        1. Quantify the use of IPC in recovery following EIMD.        2. Identify any effect of IPC during recovery on muscle function   "
105298|NCT01907828|"     The purpose of this post market clinical investigation is to complete preliminary evaluation     on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System     and cardiac ablation will result in improved outcomes as compared to ablation alone in     patients with uncontrolled hypertension being treated for Atrial Fibrillation   "
105299|NCT01907815|"     This phase II trial studies how well trametinib and protein kinase B (Akt) inhibitor     GSK2141795 work in treating patients with acute myeloid leukemia. Trametinib and Akt     inhibitor GSK2141795 may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
105300|NCT01907802|"     This phase I trial studies the side effects and best dose of dabrafenib in treating patients     with solid tumors and kidney or liver dysfunction. Dabrafenib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
105301|NCT01907789|"     The goal of this clinical research study is to compare ovarian cancer screening,     risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed     oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied.      Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams,     blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal     cancer.      The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer.      In RRSO, the fallopian tubes and ovaries are removed at the same time.      In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient     does not go through menopause. The ovaries are removed at a later date. The main goal of this     study is to learn how many patients actually have their ovaries removed at a later date.     Researchers also want to learn whether the removal of fallopian tubes will decrease the risk     of ovarian cancer.   "
105302|NCT01907776|"     This is a single-center, randomized, double-blind, placebo-controlled, sequential group     study. The primary objective of this study is to assess the tolerability and safety of single     doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to     determine the systemic exposure to, and urinary elimination of, ME1100.   "
105303|NCT01907763|"     The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients     by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral     administration of SOTB07 200mg, 400mg, placebo for 12 weeks.   "
105305|NCT01907737|"     Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of     stroke is more dramatic in low- and middle- income countries, and the scarcity of     evidence-based rehabilitation interventions represents a major challenge to global health     care. Upper limb weakness is frequent after stroke, but there is no universally accepted     treatment to effectively improve hand function in patients with moderate and severe motor     impairment. These are the patients in deepest need of rehabilitative interventions. This     project addresses this important issue, by testing effects of a novel approach. We will     non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor     training aided by an electrical stimulation device in patients with moderate to severe hand     weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve     stimulation, will enhance effects of motor training to a greater extent than brain     stimulation alone, peripheral stimulation alone, or no stimulation.   "
105306|NCT01907724|"     The purpose of this study is to evaluate the potential for a PK drug-drug interaction when     IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination.     Safety and tolerability will also be assessed.   "
105307|NCT01907711|"     background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional     affect holistically to people who have the disease and current management of fatigue, pain,     anxiety, depression and sleep disturbances present in this clinical entity is unsatisfactory.      Hypothesis:      The hypothesis of this essay is to contrast that acupuncture is more useful than placebo.      The investigators suggest the use of a clinical study protocol (PEC), randomized,     placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of     well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue,     anxiety, depression and sleep disorders in patients diagnosed with CFS.   "
105308|NCT01907698|"     Vaginal intercourse to promote labour onset is biologically plausible. Oxytocin release     during female orgasm, cervix mechanical stimulation and the effect of semen's prostaglandins     are possible involved mechanisms. The investigators propose to evaluate the effect of vaginal     intercourse on spontaneous labour at term.   "
105309|NCT01907685|"     Primary Objective:      To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the     maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered     sequentially on D1 & D2 respectively every 3 weeks in patients with advanced solid tumors.      Secondary Objectives:        -  To define the overall safety profile of the combination.        -  To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when          administered in combination.        -  To evaluate anti-tumor activity of the combination.        -  To evaluate potential predictive biomarkers.      The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The     objective to analyse a set of biological biomarkers in order to identify a potential     predictive signature of efficacy for AVE8062 in combination with docetaxel.   "
105310|NCT01907672|"     This study aims to test directly by means of a cluster randomized controlled trial, the     impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers,     the main non-formal outlet for drugs locally, at community level.   "
105311|NCT01907659|"     This trial is a pilot study to determine the feasibility of a randomized clinical trial     comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid     molecular viral diagnostics, and serum procalcitonin testing to standard of care for     directing antibiotic use in patients with non-pneumonic lower respiratory tract infection.     The reduction in antibiotic use in those subjects randomized to the treatment algorithm     compared to those randomized to standard care will be determined.   "
105312|NCT01907646|"     The objective of the study is to evaluate the impact and the outcome of bladder training     during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant     concurrent chemo-radiation therapy for locally advanced cervical cancer.   "
105313|NCT01907633|"     The purpose of this observational study is to assess the risk of out-of-hospital Sudden     Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current     use of a Proton Pump Inhibitor (PPI), current use of metoclopramide, or non-use of any of     these medications.   "
105314|NCT01907620|"     The aim of this study is to explore a mechanism that could potentially explain why women with     a pregnancy complicated by pre-eclampsia are described as having an increased risk of     cardiovascular disease later in life.      If the hypothesis of this study turns out to be true, that is to say that women with     pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and     that this difference persists after the delivery (6 months), a controlled randomized     interventional study aiming to evaluate either therapeutic supplementation with antioxidant     vitamins (Vit C and E) or modifications in diet could be envisaged.   "
105315|NCT01907607|"     The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case     of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib     is frequently short, and after failure with both imatinib and sunitinib, treatment remains     controversial.      Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al.     2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et     al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A,     CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005; Assamaki     et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21 deletions     target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are known to be     under the transcriptional control of E2F. RB1 sequesters E2F, which is released from the     complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a. Hence, we     hypothesize that alteration of the restriction point via deletion of p16INK4a (and more     rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads to     the overexpression of CINSARC genes, which in turn induce chromosome instability and     ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in     several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009).     Considering our molecular data, we believed that PD-0332991 warrants clinical investigation     in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is     detectable by comparative genomic hybridization which is a technique highly manageable in the     context of routine clinical care and clinical trial.      Exploratory, one-arm, multicenter, phase II clinical trial based on twostage Simon's design      To assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks (after     centralized review) in patients with documented disease progression while on therapy with     imatinib and sunitinib for unresectable and/or metastatic GIST.      This is a multicentre single-arm Phase II study evaluating the efficacy and safety of orally     PD-0332991, 125 mg/day, 21 days on/7 days off, in patients with documented disease     progression while on therapy with 2nd line sunitinib for unresectable and/or metastatic GIST.     Indeed, the usual treatment for advanced Gastrointestinal Stromal Tumors Refractory to     Imatinib and Sunitinib is best supportive care for which outcome data are already available     (Demetri et al., 2012; Italiano et al., 2012). Sixty three patients will be included in 10     centres of the French Sarcoma Group over a period of 18 months of enrolment.      Patients will be evaluated at scheduled visits in up to three study periods:        -  Pre-treatment (PRE TT): from signature of informed consent to the first treatment by          PD-0332991.        -  Treatment (TT): from the first treatment by PD-0332991 to the first 28 days following          the last PD-0332991 administration.        -  Follow-up (FUP): after treatment discontinuation, all patients must be followed up for          28 days after the last dose of the study drug for safety assessment (AEs and/or SAEs).   "
105316|NCT01907594|"     The investigators previously developed a cigarette cue extinction treatment (CET) procedure     in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue     Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that     triggers it. This is accomplished through repeated exposure to that trigger, while removing     the patient's ability to act out the conditioned response. In the present study, the trigger     is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving.     In the procedure the investigators have previously developed and intend to use again, the     participant is shown a pack of his brand of choice cigarettes. The researcher removes a     cigarette from the pack, lights it, and asks the participant to hold the cigarette without     smoking it for 90 seconds. This procedure is repeated seven times over the course of a     six-hour lab session. The investigators hope to boost the clinical response to smoking cue     exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by     pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS).     Behavioral extinction training is a form of learning that may be modulated by NMDA receptor     mediated glutamate transmission. The study's main hypothesis is that the partial NMDA     receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent     relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of     cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking     treatment. Development of an effective treatment strategy to enhance the effectiveness of     NRTs would have a direct and significant positive impact on public health.   "
105317|NCT01907581|"     A gravity admission largest resuscitation and a poorer prognosis are expected for patients     experiencing socio-economic vulnerability. This is the first study in France and     investigating the field of resuscitation which will allow us to have a vision of the French     health system and its consequences. The frequency of PTSD is expected to be more important in     this vulnerable population itself with quality of life at discharge worse. The results of     this study are a prerequisite for the implementation of preventive measures targeted and more     suitable for those patients experiencing socio-economic vulnerability remediation.   "
105318|NCT01907568|"     Psychotic symptoms (hallucinations and delusions) are present in several psychiatric and     neurological disorders as well as in the general population. Effective treatment strategies     for these symptoms in all patients are lacking and treatment-response can presently not be     predicted. To date, the exact pathophysiological mechanism of these symptoms remains unknown.     By investigating (subtypes) of hallucinations and delusions in all populations, a common     pathway may be found, leading to more effective treatment options. Alternatively, different     subtypes may be associated with different pathophysiological mechanisms.   "
105319|NCT01907555|"     This project will make it possible to better understand the natural history of Cohen Syndrom     and the phenotypes associated with mutations in the VPS13B gene, to improve the therapeutic     management of patients. It will also provide a better description of Cohen-like syndrome for     genetic counselling for the families concerned.   "
105320|NCT01907542|"     Background Stapled skin closure is frequently performed following open colectomies. However,     its pain and cosmetic outcomes have been suboptimal. Monocryl sutured skin closure has been     shown to be cosmetically superior and does not require removal of the sutures. But its     association with wound infection has been questioned Aims This study aims to compare the     outcomes using skin stapler or Monocryl suture in the skin closure following open colectomy.     Hypotheses We believe Monocryl suture is associated with reduced pain and better cosmesis.     Methodology Inclusion criteria: All patients who underwent elective open colectomy for     various etiologies Exclusion criteria: i) Emergency laparotomies ii) Patient who require the     creation of a stoma After consenting for the trial, patients will be randomized into either     the skin stapler or the Monocryl suture group. Randomization is performed using a computer     model. To minimize confounders, the pre-operative preparation and antibiotics regime will be     standardized. The closure of the fascia and the skin will also be performed by at least a     Registrar. The wounds will then be covered with a thick sterile dressing to blind the patient     and the research assistant. The wound will only be reviewed on the POD 3. The patient is     scheduled to return on POD 14, POD 30, 3 and 6 months post operatively upon discharge. Some     of the variables that will be collected for this study include: 1. Time taken for skin     closure 2. Superficial surgical site infection 3. Pain score 4. Cosmesis We aim to enrol 72     participants in each group. Importance/Impact to Medicine This study will validate the role     of Monocryl suture as an effective method for skin closure following open colectomy. We     believe Monocryl sutured closure can potentially change the practice of surgeons worldwide     for the benefits of the patients.   "
105321|NCT01907529|"     The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin     in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for     breast cancer patients. The hypothesis of this protocol is that the combined an active     angiogenesis agent to chemotherapy could enhance the pathological responce rate and further     benefit breast cancer patients.   "
105322|NCT01907516|"     To compare compliance and satisfaction between a traditional method of blood glucose     reporting using voicemail (control) and a novel method using cell phone /internet (Confidant)     technology in the management of diabetic pregnant women.   "
105323|NCT01907503|"     To assess the prognostic value of a characteristic evaluation of gait in persons suffering     from hip OA for subsequent indications for THR.   "
105324|NCT01907490|"     The purpose of the study is to evaluate the safety and tolerability of a single application     of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.      Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in     Ha44 vehicle) under maximal use conditions.   "
105325|NCT01907477|"     The aim of the present work is to study the protein expressions profiles of neutropenic     patients (with a high risk of invasive mycosis) who developed - versus who did not develop     invasive mycosis (principally aspergillosis and candidosis) in order to identify biomarkers     for the diagnosis, prognosis and /or prediction of invasive mycosis.   "
105326|NCT01907464|"     Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass     acquisition. A better understanding of this process would improve the medical treatment of     bone alteration and its long-term consequences.      160 patients (age < 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in     this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray     absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly evaluated.   "
105327|NCT01907451|"     This project aims to study the effects early individualised retraining programme on walking     ability in patients following hemiplegic stroke.   "
105328|NCT01907438|"     Susceptibility to breast cancer is related to the combination of genetic, hormonal and     multiple other environmental risk factors, such as mutations in the BRCA gene and excess     exposure to exogenous estrogen, respectively. BRCA is a nuclear protein that maintains genome     stability, by acting as a key player in the DNA repair complex. Recently, evidence has     emerged that BRCA mutation heterozygosis itself enhances aborted DNA repair and can     contribute to breast cancer initiation after exposure to irradiation. In our preliminary     results on short-term lymphocyte cultures, we found additional evidence that healthy     heterozygous BRCA1 and BRCA2 mutation carriers have a different response to DNA damage than     do non-carriers.      The main aim of our ongoing project is to identify the transcriptional modulation and     transformation potential of normal BRCA1 and BRCA2 mutation heterozygous epithelial breast     cells following irradiation and to examine how it is affected by exposure to estrogen. Our     hypotheses will be investigated by RNA-seq and microRNA-seq in order to identify a unique     molecular expression profile of the estrogen exposed cells following ionizing irradiation.      Understanding the role of BRCA heterozygosity in cell response to exposure to estrogen and to     irradiation may facilitate the development of more appropriate diagnostic and therapeutic     strategies for these individuals.   "
105329|NCT01907425|"     In the prenatal period, les supernumerary marker chromosomes (SMC) and de novo apparently     balanced reciprocal translocations are revealed by foetal karyotyping, which does not always     make it possible to determine whether the anomaly is balanced or not and does not reveal     uniparental disomy. The presence of these chromosomal rearrangements raises a difficult     question for genetic counselling during pregnancy because of the risk of intellectual     deficiency in the foetus. CGH+SNP-Array can provide information concerning 1) the balanced or     not nature of these translocations 2) the presence or not of euchromatin in the SMC 3) the     presence or not of uniparental disomy.   "
105330|NCT01907412|"     This is a research study to evaluate the effectiveness of the Family Foundations program and     to better understand how families cope with having a new baby. The research questions     include: What is the effectiveness of the Family Foundations program? How do families cope     with having a new baby?   "
105331|NCT01907399|"     There is a link between activation of the immune response inducing chronic inflammation and     both obesity and type 2 diabetes. To date, however, the cause(s) of this inflammation, the     mechanisms of the inflammatory cascade and the type of cells involved are not completely     known. The aim of our project is to study the principal cell types involved in the immune     response from a quantitative and functional point of view in obese diabetic patients versus     obese non-diabetic patients and healthy subjects who are neither diabetic nor obese.      Despite possible inter-individual heterogeneity of immune cells, the fact that this work will     be carried out by an accredited team with considerable expertise in the study of almost all     the different types of immune cells will probably make it possible to know whether cell     dysfunction and inflammation are associated with obesity or rather linked to insulin     resistance. This study will be completed later by a second study on cell infiltration in     adipose tissues in the 3 groups defined above. Better understanding of the physiopathology     and especially the mechanisms and type of cells involved in obesity-related inflammation     could quickly lead to the development of appropriate therapies that could act specifically on     the cells involved and thus preclude the onset of complications.   "
105332|NCT01907386|"     Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen     secondary to hypertension and atherosclerosis. Surgical treatment of AAA is increasingly     being replaced by endovascular aneurysm repair (EVAR) using stent-grafts (SGs). However, the     efficacy of this less invasive approach is often jeopardized by the incidence of persistent     flow within the aneurysm, called endoleaks leading to aneurysm rupture if not properly     detected and treated. Hence, a life long annual CT-scan surveillance is required increasing     the cost of EVAR, exposing the patient to ionizing radiation and nephrotoxic contrast agent.     The goal of this project is to adapt and test a new ultrasound technology called ultrasound     elastography to improve patient follow-up after EVAR and ultimately avoid the use of     CT-scans. This technique measures the deformation of the tissue secondary to blood pressure     variation (quasi-static elastography) or to a shear wave generated by the ultrasound probe     (dynamic elastography). The investigators will optimize 2 approaches to generate elastic maps     of the AAA. One approach will be a quasi-static elastography (QSE-LSME) technique developed     by our team giving an estimation of the deformation (strain) of the different components of     the AAA by the blood pressure. The second is a dynamic elastography (SSWI) technique that     will provide information on the elastic property of the AAA components.   "
105333|NCT01907373|"     Hypertension and hyperuricaemia are widespread conditions. There is significant overlap     between the two conditions. Serum uric acid (SUA) is currently recognized as a risk factor     for cardiovascular disease. Thus, at some point in their therapy, hypertensive patients with     hyperuricaemia are likely to require concurrent treatment with anti-hypertensive and     hypouricaemic agents. For this reason, it is important to determine whether there are any     pharmacokinetic interactions resulting from the concomitant administration of such     agents.Olmesartan is an angiotensin II receptor antagonist and effective and well tolerated     in the treatment of arterial hypertension. Probenecid is a well-established hypouricaemic     agent for the treatment of hyperuricaemia and gout.The goal of this study was to examine the     impact of coadministration of probenecid on the pharmacokinetic parameters and tolerability     of olmesartan in healthy volunteers.   "
105334|NCT01907360|"     This study will be conducted in 2 separate stages, the first in adolescents and the second in     children. Both Stages 1 and 2 will use an adaptive, single or multiple cohort open-label,     single-treatment, fasting design examining the pharmacokinetic (PK) effects of up to 2     separate modified release formulations (B and C) of HLD200 (54 mg).   "
105335|NCT01907347|"     Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is     associated with increased morbidity and prolonged recovery. In several clinical conditions,     FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However,     solid data to support this association in ICU patients are lacking. Only one retrospective     study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass     with mortality. In a pilot study performed in 55 ICU patients, the investigators observed     that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation     between PhA and mortality remains to be determined in ICU patients.      Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation     (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score     (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of     ICU patients. Most of these scores are time consuming and suffer some degree of     discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery     patients).      PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular     water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic     parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured     at bedside. PhA has been correlated with the disease prognosis in HIV infection,     hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These     studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU.      Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could     accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation     by CT presents great practical significance due to its routine ICU use in the initial     diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been     evaluated in ICU patients.      Therefore, the investigators aim to conduct an international multicentre prospective     observational study in ICU patients to assess the prognosis value of BIA PhA at admission,     and to compare the performances of BIA and L3-targeted CT for FFM measurement.   "
105336|NCT01907334|"     To examine whether a breathing test (methacholine challenge using impulse oscillometry) can     be used to tell the difference between two different doses of an inhaled drug, salmeterol,     delivered by Advair in children with asthma   "
105394|NCT01906567|"     The purpose of this study, to investigate whether severity of preeclampsia is associated with     altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and     maternal hair.   "
105337|NCT01907321|"     Stroke is the leading case of neurologic swallow dysfunction, or dysphagia. Post stroke     dysphagia is associated with approximately 50% increase in the rate of pneumonia diagnoses;     aspiration pneumonia is the most common respiratory complication in all stroke deaths,     accounting for a three-fold increase in the 30-day post stroke death rate. The long-term goal     of this systematic line of research is to decrease the morbidity, mortality, and health care     costs associated with disordered airway protection following stroke.      The overall hypothesis central to this proposal is that the ability to protect the airway is     dependent upon a continuum of multiple behaviors, including swallowing and cough. Safe,     efficient swallowing prevents material from entering the larynx and lower airway, and     effective cough ejects aspirate or mucus material. Currently, only one end of the continuum,     swallowing, is rigorously assessed in stroke patients. However, ineffective or disordered     cough is indicative of the inability to eject aspirate material or clear mucus and secretions     from the lower airway. Ineffective clearance and subsequent accumulation of material in the     lower airway increases the risk of chest infection. Hence, patients at the greatest risk for     chest infection would not only have disordered swallowing (dysphagia) but also disordered     cough (dystussia), meaning they are more likely to aspirate material and then cannot     effectively eject the aspirate from the airway. There is a high likelihood that swallowing     and cough are simultaneously disordered following stroke. To date, there is a treatment that     targets both swallowing and cough function in stroke patients.      Expiratory muscle strength training (EMST) increases expiratory muscle strength (Baker et     al., 2005) and there is evidence that supports its use to improve both swallow and cough     functions in patients with Parkinson's disease (Troche et al., in press). This cross-system,     device-driven approach to rehabilitating multiple contributors to airway protection deficits     is highly desirable in the stroke population due to the likelihood of the co-occurrence of     both swallow and cough disorders. To date, EMST has not been tested in stroke patients. We     propose that by including cough in the screening, evaluation and treatment processes for     disorders of airway protection, we will be able to better identify and treat patients most at     risk for airway compromise and associated sequelae.   "
105338|NCT01907308|"     This study plans to learn more about the combination of AMG 386 and docetaxel for the     treatment of advanced urothelial cancer. Subjects are being asked to be in this research     study because they have advanced urothelial cancer which has progressed after treatment with     a platinum-based therapy.      The hypothesis is that AMG 386 will increase the historical response rate of docetaxel as a     single agent.   "
105339|NCT01907295|"     Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is a rare     condition that can shorten life. Although the cause of this disease is usually unknown, in     about 70% of heritable and 15-20% of idiopathic cases there is a change in a gene (a     mutation) that controls how blood vessels grow and function. The gene is called bone     morphogenetic protein type receptor 2 (BMPR2). Although mutations in BMPR2 are a risk factor     for PAH, not everyone with a mutation gets the disease. Additional genetic and environmental     factors are likely to contribute. The investigators suspect that mutations in other genes are     responsible for some cases of PAH. In this study the investigators aim to recruit all     patients with PAH and some of their relatives and follow them up for several years. The     investigators hope to discover new mutations for this disease and to determine what factors     lead to poor outcome, and to understand what triggers disease in patients with mutations.      Who can participate? Adults with PAH, their relatives and controls (one off blood sample)   "
105340|NCT01907282|"     Preventing psychotic disorders such as schizophrenia and associated functional disability     could relieve an enormous burden of personal and family suffering and economic losses to     society. This project aims to conduct a pilot randomized trial to determine the efficacy of a     family-focused treatment in comparison with treatment-as-usual in enhancing functional     outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in     transitional age youth with prodromal symptoms. The results of this study will be crucial for     the development of cost-effective, evidence-based psychosocial approaches to psychosis     prevention and thus will have major implications for public health.   "
105341|NCT01907269|"     The purpose of this study is to conduct a randomized trial of a tailored intervention     designed to provide personalized feedback regarding patients' risk of subsequent fractures,     customized information regarding osteoporosis care, and messaging to activate patients to     become more engaged in improving osteoporosis treatment and doctor-patient communication.     This novel content will use story-telling delivered via the Internet and digital video     discs (DVDs). The content will be uniquely tailored to each person based on barriers to care,     age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this     intervention to determine differences in post-intervention rates of osteoporosis care between     two randomization arms.      We hypothesize that participants randomized to the intervention arm, compared to those     randomized to a control arm, will receive more osteoporosis care at 6 months     post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies,     (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD)     testing.   "
105342|NCT01907256|"     There was not any randomize trial to show what is the best type of incision in open     rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual     Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step     incisions.   "
105343|NCT01907243|"     Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft     is the gold standard. More recently, the spreader flap technique has been espoused as an     alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a     randomized trial setting.   "
105344|NCT01907230|"     Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in     hepatitis B inactive carriers and patients with past HBV infection   "
105345|NCT01907217|"     Electroconvulsive therapy (ECT) is the most powerful antidepressant treatment available and     is often life-saving. There are concerns, however, that standard bitemporal ECT (the most     commonly used form of ECT worldwide) causes persisting retrograde amnesia. However, clinical     trials have indicated that high-dose unilateral ECT may be as effective as bitemporal ECT but     have much less cognitive side-effects.      The trial aims to test the primary experimental hypothesis: High-dose (6 x ST) right     unilateral ECT is as effective as (i.e. not inferior to) standard (1.5 x ST) bitemporal ECT     for severe depression in terms of Hamilton Depression Rating Score (HDRS) at the end of the     treatment course.   "
105346|NCT01907204|"     The purpose of this study is to determine whether inhaled corticosteroid (specially     nebulized) could be a good alternative to oral corticosteroid and whether they are effective     in the treatment of sinusitis   "
105347|NCT01907191|"     This study is being undertaken to compare the pain control using either bupivacaine versus     liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up     to 72 hours while regular bupivacaine can provide pain relief up to 12 hours   "
105348|NCT01907178|"     To investigate postoperative pain management in patients undergoing knee or hip replacement     while they are in the hospital and following discharge to their home. Additionally, sample     questions will be asked prior to surgery to predict patient's postoperative pain experience.   "
105351|NCT01907139|"     There are 3 specific study purposes. First, we will examine the treatment effects of RT     combined with dCIT (RT + dCIT) compared to RT, dCIT, and a dose-matched control therapy     (DMCT) in stroke patients. Outcome domains will include motor, sensory, and muscle functions,     amount of arm activity in real-life situations, patient-reported outcomes of daily     performance and quality of life, and kinematic performance. Additionally, potential adverse     effects including fatigue, pain, and a biomarker of oxidative stress will be examined.     Second, we will investigate if the demographical and clinical characteristics of stroke     patients may predict the probability of achieving clinically important changes of treatment     outcomes. Thirdly, this study will examine whether the improvements after treatment reach     clinically important or not and assess clinimetric properties of the outcome measures.   "
105352|NCT01907126|"     The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women     with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the     feasibility and acceptability of the proposed recruitment methods and research design, of the     intervention training methods, of delivering the enhanced Women's Coop and nutrition control     interventions. Per recent guidance from NIMH, the investigators will also examine 95%     confidence intervals around differences between the proposed intervention and a dose-matched     control condition (Nutrition Program), for the following outcomes through 8 months post     prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal     trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and     depression, and drug using/heavy drinking days (secondary); and increased affect management     and social support (including effectiveness in obtaining substance use, mental health     treatment and other resources) (tertiary).   "
105353|NCT01907113|"     Assessment of the effect of normal and impaired kidney function on the pharmacokinetics,     pharmacodynamics and safety of BI 10773   "
105354|NCT01907100|"     This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of     nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF     1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of     patients with unresectable malignant pleural mesothelioma.   "
105355|NCT01907087|"     The purpose of this study is to determine whether BMN 190 is safe and effective in the     treatment of patients with Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)     disease.   "
105356|NCT01907074|"     As the treatments for liver disease and the availability of liver transplantation have     progressed, the number of patients with end stage liver disease continues to increase. This     has increased the need to risk-stratify patients with cirrhosis to better direct their     treatments and provide an accurate prognosis for their outcomes. The traditional assessment     of the liver patient has been limited to imaging, static measures of liver function tests     and liver biopsy. This protocol is designed to increase the spectrum of tests in the     evaluation of the patient with end stage liver disease.   "
105357|NCT01907061|"     Trial to test the effect of administering N-acetylcysteine on cytokines and markers of     oxidant stress and the incidence of acute renal failure post liver tranplant   "
105358|NCT01907048|"     This cross-sectional epidemiologic study will measure physician and patient awareness and     understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert     card.   "
105359|NCT01907035|"     OBJECTIVE: Evaluate the effectiveness of quality of life score, a cognitive-behavioral     intervention by psychologists in the field of primary care in anxiety-depressive patients,     mild to moderate, compared with usual care.      DESIGN: Clinical trial, multicenter, prospective, and randomized into two parallel groups.     SCOPE AND SUBJECTS: We included a random sample of 246 patients anxious-depressive, mild /     moderate, belonging to the target population of 41 doctors from several health centers.     INTERVENTION: In the 246 patients randomly assigned to the intervention group, with a     standardized program of cognitive behavioral therapy applied by psychologists, by the usual     treatment or control group, which will be standard care. MEASUREMENTS: The main result will     be changes in general health scores of the SF-36. It will also measure the change in     frequency and intensity of anxiety-depressive symptoms on the scales HARS, HDRS, STAI and BDI     at baseline and at 2, 6 and 12 months. In addition, also collected for drug use and health     services.      ANALYSIS: Analyses were performed by intention to treat, comparing the change obtained in     both groups at the end of the 12 month follow up. Estimates of the effect attributable to the     intervention by the difference in those changes, adjusting in addition to the baseline, the     possible confounding covariates or effect modifiers of the intervention, using longitudinal     mixed-effects models.   "
105360|NCT01907022|"     Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used     to modulate the neural pathways contributing to the perception and distress of phantom     sounds.   "
105361|NCT01907009|"     The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly     complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen     blockade) is common place. Following the failure of such an approach, several strategies may     be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is     being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that     this is viewed by many as the standard of care for fit patients.      Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but     to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I     dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that     median overall survival is 22 months, which is higher than the median survival rate of 19     months for Docetaxel      Data from a previous phase I study has proved the successful administration of higher doses     of IV Melphalan in combination with autologous blood infusion in patients with     Castration-resistant prostate cancer.      Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan,     however slow platelet recovery meant longer periods of platelet transfusion. For this study     we intend to assess the efficacy of an intensified intravenous melphalan with autologous     whole blood stem cell transplantation over three treatment cycles.      39 patients will be enrolled over a 3 year period and at least 17 patients need to survive     progression free at least 6-months for this study to be considered positive.      Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs:      MELPHALAN and LENOGRASTIM for 3 cycles alternately.   "
105362|NCT01906996|"     There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the     proximal row carpectomy and the four corner fusion. They are used to reduce pain and to     maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a     better mobility of the wrist postoperatively, whereas the four corner fusion has lower     progression of radiocarpale osteoarthritis.      The purpose of this study is to compare the clinical, radiological and subjective outcomes     after the treatment with a proximal row carpectomy or a four corner fusion.   "
105363|NCT01906983|"     The true incidence of thrombosis in the portal venous system after blunt splenic trauma is     unknown and has not been elucidated in the medical literature. The investigators hypothesize     that this entity is more common than previously suspected. Consequences of missing this     diagnosis can be clinically significant, i.e. mesenteric ischemia in the acute phase and     portal venous hypertension in the chronic phase. Early diagnosis would facilitate treatment     with anticoagulation and avoidance of these complications. In a prospective fashion, doppler     ultrasound will be performed prior to discharge and at 3 months in all patients 18 and up who     have sustained blunt splenic trauma. Clinical follow-up will be extended to 6 months in     patients initially diagnosed with thrombosis in the portal venous system on their 3 month     ultrasound. The investigators will attempt to identify risk factors in this trauma population     that would facilitate an early screening protocol.   "
105364|NCT01906970|"     A single centre, clinical experimental study. Every subject will undergo clamp experiments,     where a clamp device (ClampArt®) measures and controls the blood glucose concentration after     administration of marketed insulin products.   "
105365|NCT01906957|"     The aim of study is to investigate the impact of two different training modalities (high     intensity interval training (HIIT) versus moderate intensity continuous exercise training     (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness     in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart     failure. The investigators hypothesized that HIIT modality will lead to a larger improvement     in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke     volume) and cognitive performance at rest and during submaximal exercise. The primary     endpoint will be the improvement in cognitive performance.   "
105366|NCT01906944|"     Patients with chronic abdominal pain- with a component of abdominal wall pain- are often     treated with trigger point injections. This study will help to determine if a block within     the transversus abdominis plane (TAP) will provide superior analgesic benefit to a trigger     point injection as therapy for these patients.   "
105367|NCT01906931|"     People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to     increase oxygen levels in the blood during daily activities. The best way of delivering this     type of oxygen has not been established. The aim of this study is to compare two devices for     delivering oxygen in people with interstitial lung disease - the traditional method using     portable cylinders and a newer method using a portable concentrator. The investigators     hypothesise that oxygen levels during exercise will be significantly higher when using a     portable cylinder, but this difference will be small.   "
105368|NCT01906918|"     Strategies for myocardial protection during open heart surgeries are desired. Several     experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC).     The underlying mechanisms are not totally understood. This study intends to evaluate     molecular mechanisms involved with RIPC on myocardium of patients underwent open heart     surgeries.   "
105369|NCT01906905|"     Trancranial Magnetic Stimulation (TMS) is a non-drug and non-invasive treatment for     depression and has been investigated for the treatment of psychiatric illness for over 15     years. There is now established evidence indicating TMS is an effective treatment for     depression. However, the effectiveness of TMS varies between people, thus requiring further     research to investigate its optimal application. Investigators want to compare the     effectiveness of different forms of TMS, given with differing stimulation settings to the     right or left side of the brain that has been associated with depression. This could     potentially help clinicians in the future to improve the prescription of TMS as a treatment     for depression.   "
105370|NCT01906892|"     This study explores the hypothesis that mental health service users, their carers and     musicians can - through the creative act of music learning and performing - mutually enhance     wellbeing through the development of more meaningful and resilient lives. The project seeks     to explore three interconnected issues: (i) the extent to which music learning and performing     provides a forum for 'mutual recovery' among adult mental health service users, their     formal/informal carers, and musicians, (ii) the characteristic features of 'mutual recovery'     through music, and (iii) the underlying mechanisms of such 'mutual recovery'.      The study will consist of three different stages. Stages 1 and 2 will examine the effect of a     variety of group activities - including participatory music, listening to live music,     listening to recorded music and a non-music control - on psychological scales, saliva samples     of stress hormones and cytokines, and subjective experience to see which provide the most     relaxing, sociable and supportive environments for mutual recovery. Stage 3 will explore the     impact of musical interventions over longer periods of time.      A systematic review we have just carried out has revealed a major gap in research comparing     different music interventions and testing the effects of different lengths of interventions.     As a result, our study should help us answer the following questions:        -  Which aspect(s) of music can contribute to mutual recovery?        -  Do carers, patients and musicians all respond to the same activities, or do some musical          activities suit certain groups more than others?        -  Do carers, patients and musicians all recover at the same rate?        -  What length of intervention is most effective?      If certain interventions are found to produce stronger results than others, these results     could help guide community groups and healthcare settings in their design of music activities     and have implications for the spending of arts-in-health budgets.   "
105371|NCT01906879|"     Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth     quadruple therapy or triple therapy for 14 days remains unknown.      Therefore, we aim to compare the eradication rates and long term re-infection rates of     quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple     therapy for 14 days.      Methods: This will be a multi-center, open labeled, randomized control trial Patients: H.     pylori infected patients who have willingness to receive eradication therapy      Testing for H. pylori infection Before First Line Ttreatment      (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT     will be considered as H. pylori infected      After First Line Treatment: C13-Urea breath test will be used to assess the existence of H.     pylori 6-8 weeks after first line therapy.      Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H.     pylori 1 year after eradication therapy   "
105439|NCT01905982|"     The purpose of this study is to determine whether different types of breathing therapies in     patients with COPD III-IV decrease dyspnea, increase activity and have impact on     parasympathetic activities.   "
105372|NCT01906866|"     The purpose of this study is to establish the efficacy and safety of Circadin in children     with neurodevelopmental disorders and to determine the dose, this randomized,     placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week     treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and     additional parameters in children with neurodevelopmental disabilities. The efficacy and     safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period     of 13 weeks.   "
105373|NCT01906853|"     1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a          reduction in measures of allergy and infection in the first 12 months of life.        2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by          comparing markers of immunity between the BCG and non-BCG groups.   "
105374|NCT01906840|"     Despite advances in prevention of cardiovascular diseases, the incidence of accelerated     atherosclerosis in hemodialysis (HD) patients has still remained high. Oxidative stress is     considered as a major player in uremia associated morbidity and mortality in HD patients. The     aim of this study was to evaluate the effects of turmeric on oxidative stress markers in HD     patients.   "
105375|NCT01906827|"     The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in     cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function     like fetus.Increased P-wave duration and P-wave dispersion have been reported in various     clinical settings. The investigators hypothesized that PWD and p wave duration may affect in     pregnancy with ICP.   "
105376|NCT01906814|"     The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) are as     effective as 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated     retinoblastoma.   "
105377|NCT01906801|"     The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and     change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24     weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine     in OA patients   "
105378|NCT01906788|"     The investigators' Hypothesis is that The correct timing of gametocytocidal drug in     combination with an effective Artemisinin Combination Therapy can limit the infectiousness of     malaria-infected individuals to less than one week after initiation of treatment   "
105379|NCT01906775|"     Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen     ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can     increase mortality. This study aimed to determine the role of back-up pacing-induced VT (PIT)     to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing by     programming the pacing output to a sub-threshold level for ineffective pacing.   "
105380|NCT01906762|"     Kidney stone is one of the most common diseases in every human society and also Iran. What is     normally used to treat renal colic pain is Intravenous Opioid with a variety of side effects     including hypotension, respiratory depression and apnea, nausea and vomiting. Regarding less     complications of Intravenous Acetaminophen, we aimed to compare it with Intravenous Morphine     in management of renal colic pain.   "
105381|NCT01906749|"     Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine     (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years     after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the     specified combined endpoint from 16% to 7-8% at a 2-years follow-up.   "
105382|NCT01906723|"     Unstrained ambulation is the main goal of gait rehabilitation for preventing fatigue and     increasing functionality in patients with gait deficiencies. The Up n' Free (Easy Walking) is     a gait trainer equipped with a dynamic partial weight-bearing. The trainer is designed to     provide the user with independence, safety, and endurance. It allows for easy transfer from     sitting to standing position and stabilizes the pelvis, allowing for free movement of the     hands. The effectiveness of the Up n' Free trainer in increasing the patient's functionality     at the hospital or at home has not been quantified. We therefore aim to evaluate     effectiveness of the gait trainer in increasing the functionality and spatiotemporal     parameters of gait of 4 patients.   "
105383|NCT01906710|"     The purpose of this study is to determine whether a hospital pharmacy team (pharmacy     technicians and pharmacists) together with (recently admitted) patients are able to diminish     the number of drug related problems including adverse drug events, made before, during and     after admissions resulting in reductions of re-hospitalizations and costs.   "
105384|NCT01906697|"     The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF)     turbinoplasty with middle turbinate resection and medialization   "
105385|NCT01906684|"     This study will determine changes in: 1) the immune activity, characterized as the     immunorepertoire; 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient     reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who     are treated with Acthar Gel.   "
105386|NCT01906671|"     Acute lymphoblastic leukemia (ALL) accounts for 30 % of all childhood malignancies. The     patients undergo four phases of treatment, finishing with a late maintenance phase in which     6-mercaptopurine and Methotrexate are essential components. Insufficient treatment intensity     in this phase is associated with increased risk of relapse. Excessive variation in the     bioavailability of 6-mercaptopurine has been observed which can cause both risks of     undertreatment/relapse as well as overtreatment with severe side effects.      In the attempt to achieve individualized 6-mercaptopurine dosing different approaches have     been pursued. Nonetheless variation in bioavailability remains a problem.      Earlier, oral tablets of 50 mg (Purinethol) were the only administration form of     6-mercaptopurine and it was primarily designed for adult patients. Challenges with accurate     dosing and getting the children to swallow the tablets have been a widespread problem,     forcing the caregivers to divide or crush the tablets as well as having to administer     different dosages over 2-3 days. Due to these problems, an oral liquid formulation of     6-mercaptopurine (Xaluprine) has been developed. However this oral liquid has only been     tested on healthy adult volunteers, and not on the target group, childhood patients. This     project will assess the bioavailability and plasma kinetics of oral liquid and tablet     formulation of 6-mercaptopurine in children with acute lymphoblastic leukemia.      The investigators hypothesize to observe comparable plasma kinetics, in children with acute     lymphoblastic leukemia when treated with 6-mercaptopurine in the form of a tablet and oral     liquid formulation, as previously observed in healthy adults.   "
105387|NCT01906658|"     This 8-week randomized, open-label evaluation will examine the acute safety and tolerability     of 4 different dosing regimens of Acthar to inform dose selection for future studies of     Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate     the mean rate of change in the ALSFRS-R total score as an exploratory endpoint to help design     future studies.      This study will enroll up to 40 patients and include an optional 28-week open-label extension     period plus a 3-week treatment taper and 1-week follow up period. After completion of Week 8,     patients enrolled in a treatment group that is considered safe and tolerable at that time     have the option to continue into the open-label extension period. A 3-week treatment taper     and a follow-up visit are planned for all patients enrolled in the study, beginning either at     Week 8 or at Week 36 if a patient continues into the optional open-label extension period.   "
105388|NCT01906645|"     The purpose of this protocol is to evaluate the Care Transitons Innovation, a quality     improvement project being implemented at OHSU to improve the transition from hospital to home     for uninsured and Medicaid patients admitted to general medicine and cardiology wards at     OHSU. The evaluation includes a baseline in-person survey and a 30 day post-discharge phone     follow-up survey. Prior to C-TraIn, the local healthcare delivery model lacked an effective     way to assure timely, safe, and effective follow-up care for uninsured and underinsured     hospitalized patients. Most uninsured patients have no source for primary care, and many have     limited social support, complex medical problems, and are prescribed many medications.     Patients are frequently discharged without any coordinated plan for follow up. Based on a     needs assessment performed in 2009 (OHSU eIRB 5514) investigators developed a quality     improvement program that will include three major components: 1) a care transitions RN     advocate who will see patients in the hospital and after discharge, 2) a pharmacy     consultation and 30 days of medications post-discharge, 3) linkages with primary care medical     homes, including payment for primary care for uninsured patients who lack a usual source of     care, and 4) monthly meetings that serve as a platform for continuous quality improvement. In     order to measure the success of our program, investigators will track patient utilization,     sociodemographic factors, and patient factors including satisfaction, activation, and     self-reported health status. To be included patients must be uninsured, have Oregon Medicaid,     or be low income (200% or less of federal poverty level) Medicare recipients, and live within     Multnomah, Washington and Clackamas Counties in Oregon.   "
105389|NCT01906632|"     To investigate gene expression profile and immunological associated analysis relating to     immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.   "
105390|NCT01906619|"     Febrile seizures occur in 2-5% of the population and are typically limited to children     between 3 months and 5 years-of-age. The pathophysiological link between increased body     temperature and increased seizure susceptibility is unsolved in humans. In a mouse model it     has been shown that young animals had a tendency to hyperventilate thereby causing     intra-cerebral hypocapnia / alkalosis and a decrease of their seizure threshold. This effect     was not observed in older animals. Redressing the pCO2 (carbon dioxide partial pressure) by     breathing carbon dioxide enriched air instantly stopped the seizures.      In this study the investigators want to investigate the respiratory physiology in children     with febrile seizures and compare it to children who have fever but did not have febrile     seizures.      The investigators hypothesize that in children with febrile seizures the rising body     temperature triggers a larger increase of respiratory rate (hyperventilation) and subsequent     drop in pCO2 levels.      This study could provide the basic physiological data for an interventional trial to test the     efficacy of carbon dioxide inhalation to interrupt febrile seizures.   "
105391|NCT01906606|"     The purpose of the current study involves the development, implementation and evaluation of a     parenting program to target maternal well-being and child health, growth and development in     Lira, Uganda. The current study aims to address maternal care within a parenting program as     well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation     through peer-support, practice and problem-solving. Outcomes include child health, growth and     development, maternal mental health, mother-child interactions, and maternal-spousal     relations.      We hypothesize that:        1. Children of parents who attend the parenting program will have better health, height and          cognitive/language development at post-test, than children whose parents did not have          the opportunity to attend parenting sessions.        2. Parents who attend the parenting program will have more knowledge about child          development and provide more home stimulation, dietary diversity and preventive health          practices than parents who do not have the opportunity to attend parenting sessions.        3. Mothers who attend the parenting program will have improved well-being compared to          mothers who do not have the opportunity to attend parenting sessions.   "
105392|NCT01906593|"     To monitor the safety of Beijing Tiantan Biological's influenza vaccine in elderly through     Adverse Events Following Immunization Surveillance System of China.      The hypothesis is that there is no significant difference in the occurrence of adverse events     among influenza vaccines manufactured by independent companies.   "
105393|NCT01906580|"     Currently, seven medications are approved for the treatment of hepatitis B: two formulations     of interferon and five nucleons(t)ide analogues. The current treatment strategy of chronic     hepatitis B is now standard: initial selection of entecavir, tenofovir, or peginterferon     alfa-2a (peg-IFNα-2a). Interferon is administered for a finite duration while nucleotide     analogues are usually administered for many years. But among hepatitis B e antigen （HBeAg）     positive patients with high serum hepatitis B virus DNA levels, the rates of virological     response are poor. And antiviral drug resistance is a major limiting factor to the success of     nucleotide analogue treatment. Therefore, combination therapy using peginterferon with an     oral agent with a high genetic barrier to resistance might be superior to standard current     monotherapy. However, the addition of lamivudine to peg-IFNα-2a therapy led to a greater     decrease in serum HBV DNA levels during treatment but did not increase the rate of HBeAg     sero¬conversion. Entecavir is a nucleoside analogue superior to lamivudine and adefovir in     achieving higher virological response, histological improvement and normalisation of ALT.     Moreover, Entecavir has a high genetic barrier with a very low incidence of drug resistance.     This study is aimed to investigate the efficacy of combination or sequential therapy using     peg-IFNα-2a and entecavir in HBeAg-positive chronic hepatitis B(CHB) patients.   "
105395|NCT01906554|"     Eggs contain an essential nutrient called choline and adequate levels of choline are required     for good health. Studies in mice have demonstrated that high levels of choline may increase     risk of heart disease through a process that involves the breakdown of choline by gut     bacteria. Previous research did not show that human consumption of eggs increases risk of     heart disease. This study is designed to investigate whether the number of eggs in the diet     affects blood and urine markers for heart disease.   "
105396|NCT01906541|"     X-linked chronic granulomatous disease (X-CGD) is a rare inherited immune defect, which is     caused by the inability of phagocytic cells to produce reactive oxygen species due to a     defect in the gp91phox subunit of the NADPH oxidase complex. X-CGD patients suffer from     recurrent and life-threatening infections and severe hyperinflammatory complications.      The only curative treatment for X-CGD is allogenic hematopoietic stem cell transplantation,     but this procedure implies severe risks and many patients lack an appropriate donor.     Therefore alternative curative approaches are urgently needed. In this study, patients will     be treated with gene-corrected autologous CD34+ cells, using a SIN gammaretroviral vector for     ex-vivo gene-therapy.   "
105397|NCT01906528|"     Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous     studies have shown that males and females respond differently to this kind of drug. Our     hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant)     than females, meaning that males need a lower blood concentration of the drug than females in     order to obtain a given effect.   "
105398|NCT01906515|"     Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time     trending of changes or lack of changes in hemoglobin, which has the potential to alter red     blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the     impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators     hypothesize that SpHb will improve blood transfusion practice in the for of change the number     of blood unit per patient and improve the outcome regards the time to take decision of     transfusion trigger.   "
105399|NCT01906502|"     A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on     healthy volunteers and patients with glaucoma. However, healthy subjects were much younger     than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database     was almost twice higher than the number of healthy subjects. As it is generally accepted that     intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is     of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore,     improving our knowledge of the healthy 24-hour IOP pattern in comparison to glaucoma     profiles would be beneficial for management of glaucoma.   "
105400|NCT01906489|"     The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and     tolerability of orally administered AKB-6548 in patients with Chronic Kidney Disease     (pre-dialysis) with anemia with dosing for 20 weeks.   "
105401|NCT01906476|"     This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT)     with a therapist to a Stepped Care intervention for depression treatment (iCBT with support     from a telephone coach with the possibility of being stepped up to receiving T-CBT with a     therapist).   "
105402|NCT01906463|"     This study should also raise questions about the interest and feasibility of establishing a     permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected     doubling of the population of persons aged over 60 years and the foreseeable changes in     lifestyle will increase the burden of this disease, in particular since the region is marked     by a high prevalence of arterial hypertension and diabetes and a high level of precarity. In     addition, this study will provide epidemiological information on CVA, its risk factors and     management, which are non-existent for the department of French Guyana where the health     environment is manifestly insufficient. These data should make it possible to better evaluate     the resources available and the healthcare needs in Guyana.   "
105403|NCT01906450|"     Human periodontitis is a group of highly prevalent oral inflammatory diseases and infections     with relatively easy treatment and preventive features. The present study is aimed to     determine if treating human individuals with chronic periodontitis, along with the use of     antibiotics, reduces cardiovascular risk marker (HsPCR) and also intends to identify if     severity of periodontitis could be associated with a raise of systemic inflammatory     biomarkers on baseline.   "
105404|NCT01906437|"     A study to test the effectiveness of an investigational imaging technique for detecting     cardiac injury after the administration of certain chemotherapies, such as doxorubicin.     Investigational means that the imaging technique is still being studied and that research     doctors are trying to find out more about it- such as whether the technique can detect lower     levels of cardiac injury after treatment with doxorubicin. It also means that the FDA (the     U.S. Food and Drug Administration) has not yet approved the use of gadolinium or approved the     use of CMR studies for detection of cardiac toxicity after doxorubicin.      The chemotherapy drug that you have been scheduled to be treated with, doxorubicin, has been     associated with the development of heart failure in some patients. Cardiac Magnetic Resonance     (CMR) is a type of MRI scan that uses a magnetic field to produce pictures of the heart. The     CMR scan has been used in other studies and information from those other research studies     suggest that this imaging technique may help to better detect differences in the structure of     the heart muscle after treatment with doxorubicin. In this research study, we hope that we     can better detect changes in the heart muscle after treatment with doxorubicin with a CMR     scan in the hopes that cardiac injury can be detected and treated earlier to ultimately     prevent the possible development of heart failure   "
105405|NCT01906424|"     This study is to determine if non-invasive electrical stimulation of the spinal cord can help     improve hand and arm function in people with paralysis who suffered a cervical spinal cord     injury.   "
105406|NCT01906411|"     The broad aim of the study is to obtain a better understanding of alterations in mesolimbic     reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in     obesity.      This will be achieved by integrating a functional neuroimaging (fMRI) with behavioral reward     tasks and the modulation of the dopamine level by dopamine depletion.   "
106180|NCT01896219|"     Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY,     EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of     interventional radiology under scan in the thoraco-abdominal level.   "
105407|NCT01906398|"     The purpose of the study is to obtain pilot data on safety and efficacy of ketogenic diet     (KD) as adjunctive treatment of adults with refractory epilepsy. This will be an open label     study comparing seizure frequency during 4 months of prospective baseline observation period     with seizure frequency during 4 months of add-on KD treatment. 18-65 year old men and women     with refractory epilepsy, defined as seizures persisting in spite of past/present treatments     with ≥ 3 AEDs, with seizure frequency of ≥ 0.5/month, will be evaluated. Subjects with both     primary generalized and localization-related epilepsy (PGE, LRE) will be recruited. Subjects     will have had epilepsy for at least 2 years prior to enrollment. Following initial screening,     subjects will be observed for 4 months, with no change in AEDs except when deemed necessary     by the patient's neurologist according to standard clinical care. Patients will then start     ketogenic diet. Evaluations will include seizure frequency using a seizure diary, adverse     events, treatment compliance using urine and plasma ketone levels. Quality of life will be     evaluated with a standardized questionnaire of Quality Of Life In patients with Epilepsy,     QOLIE-31-P. Level of alertness will be evaluated with Epworth Sleepiness Scale. These     questionnaires will be administered at each visit.   "
105408|NCT01906385|"     While radiation is an essential component to the treatment of glioblastoma, it's use is     limited due to toxicity when higher doses are attempted. Rhenium is a compund which releases     radiation in small particles that are absorbed after only a fraction of an inch. This limited     penetration means that high doses potentially can be given without the toxicity of other     forms of radiation. In order for the radiaiton to be retained within the tumor, it has been     packaged in microscopic fat like particles termed nanoliposomes. These facilitate the uptake     of the radiation particles by the tumor. In order to better characterize this form of     radiation therapy, it is being administered in patients who have failed other forms of     therapy for glioblastoma. The treatment is administered by tubing inserted into the center of     the tumor in the operating room. There are two portionms to this study. The first involves     progressively increasing doses until the most tolerable dose can be identified. The second     portion of the study involves a larger number of patients being treated at the determined     most tolerable dose to better evalaute how well the treatment works.   "
105409|NCT01906372|"     The purpose of this research study is to evaluate the effectiveness of the study drug, ACTH     Gel in people diagnosed with dermatomyositis a disease that causes muscle weakness and is     associated with a rash (DM) or polymyositis (PM) a disease that causes muscle weakness     without a rash. The study doctors want to evaluate whether ACTH Gel will improve the symptoms     of this disease. This drug is approved by the Food and Drug Administration (FDA) for     dermatomyositis (DM) and polymyositis (PM). ACTH gel has been an FDA-approved treatment for     myositis since 1952, and in 2010 the FDA retained PM and DM as diseases approved for ACTH gel     use.   "
105410|NCT01906359|"     Type 2 diabetes mellitus (T2DM) is a chronic disorder determined by lifestyle and genes. It     is associated with chronic hyperglycaemia along with other metabolic abnormalities. It is     also one of the risk factors for cardiovascular disease (CVD). This disease is due to insulin     resistance and/or deficiency as well as increased hepatic glucose output. According to the     Third National Health and Morbidity Survey (3rd NHMS), the prevalence of T2DM for adults aged     30 years and above is 14.9%, increased by almost 80% from 1996 to 2006. Dietary composition     may affect insulin sensitivity, postprandial triacylglycerol concentration and the risk of     T2DM. The role of dietary fats in T2DM is of particular interest and has been clinically     studied for many decades. The type of fat we ingest every day consists of different types of     fatty acids and different degree of saturation, which in turn influence glucose metabolism by     altering cell membrane function, enzyme activity, insulin signalling and gene expression.     Previous studies demonstrated that interesterification of dietary fat alter postprandial     lipaemia. Saturated fat such as palm olein has been reported to display lower postprandial     lipaemia after interesterification. Changing the structure of triacylglycerol (TAG) alters     the physical properties of dietary fat which affects digestibility, metabolism and     atherogenicity. A recent study conducted by Sanders and co-workers demonstrated reduced     levels of plasma glucose-dependent insulinotropic polypeptide (GIP) following both the lard     and interesterified palm olein (IPO) compared with the palm olein (PO) and high oleic     sunflower oil (HOS) diets in healthy subjects. The GIP and glucagon-like peptide-1 (GLP-1)     are major players in the modulation of postprandial insulin secretion by the pancreas.     Although GIP secretion in response to meals is normal in patients with Type 2 diabetes     mellitus (T2DM), GIP induced secretion of insulin is defective in diabetes. This is observed     to be predominantly a defective stimulation of the late phase of insulin response (20-120     minutes). The effect of IPO on GIP may be exaggerated in T2DM patients with impaired insulin     sensitivity. Hence, IPO may change the concentrations of gut hormones, postprandial lipaemia,     insulinaemic response and CVD related haemostatic markers.   "
105411|NCT01906346|"     Cocaine-use disorders continue to be a significant public health concern, yet no effective     medications have been identified. The goal of this study is to establish a research platform     for the development of medications for treatment of cocaine abuse and dependence. This study     will incorporate self-administration procedures and a non-drug alternative reinforcer, which     is hypothesized to reduce the reinforcing effects of cocaine.   "
105412|NCT01906333|"     There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid,     IMCL) markedly increases the risk of metabolic complications, including insulin resistance     and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively     taking up FFAs when the availability is high, thereby leading to an increased storage. To     test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise,     and monitor intramuscular lipid content.      Therefore the objective is to examine the effect of an exercise-induced elevation of FFA on     skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid content     will be investigated at baseline and after an exercise protocol and again after a four-hour     recovery period from exercise, once in a condition with high FFA concentration, once with low     FFA concentration. To achieve high- versus low FFA concentrations, an exercise protocol was     chosen and participants had to perform this protocol once with a glucose supplementation and     once without.      Skeletal muscle lipid content will be determined before, directly after exercise and 4 h post     exercise (from muscle biopsies) with or without glucose supplementation.   "
105413|NCT01906320|"     The aim is to test the hypothesis that high-resistance training for 8 weeks, following the     recommendations for healthy adolescents, is capable of eliciting increases in muscle     strength, agility, skeletal muscle mass, and functional capacity without losing weight, body     mass index (BMI) or fat mass in anorexia nervosa restricting type patients. Further, we     hypothesize that the effects produced by the high-resistance training program will be     maintained 4 weeks following the completion of the training program.   "
105760|NCT01901731|"     The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic     coil embolisaton) in females with leg varicose veins, who have a proven contribution to their     leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose vein     surgery.   "
105414|NCT01906307|"     Hepatorenal syndrome (HRS) is a life-threatening condition marked by rapid decline in kidney     function in patients with liver cirrhosis or fulminant liver failure. Vasodilation in the     gastrointestinal region is largely thought to contribute to the disease. LJPC-501 is a     vasoconstrictor that may restore proper circulation and kidney function in patients with HRS.   "
105415|NCT01906294|"     This observation plan outlines the approach to build a diabetes registry to collect data on     daily routine of treatment of Type 2 Diabetes Mellitus.   "
105416|NCT01906281|"     Adipocytokines play an important role in joint inflammation in patients with knee     osteoarthritis as measured by ultrasound and high sensitivity protein-C reactive.     Adipocytokines could be the link between osteoarthritis and cardiovascular risk factors more     prevalent in these patients.   "
105417|NCT01906268|"     The objective of this project is to test the combination of active or placebo Attentional     Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant     to antidepressants.   "
105419|NCT01906242|"     Adequate denture hygiene is important to patient's oral health maintenance in particular     because of Candida albicans, responsible for the development of denture stomatitis. The aim     of this study is to conduct a randomized controlled trial seeking for the best hygiene     protocols to be used in removable denture wearers. The null hypothesis tested is that there     will be no difference among the denture hygiene protocols tested.   "
105420|NCT01906229|"     Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation,     that may be caused by a variety of insults with pulmonary and systemic infectious disease     being the most common predisposing factor. Sepsis, on the other hand, represents the systemic     inflammatory response to an invading pathogen, which may inflict damage upon the host through     organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that have a high     mortality, and both diseases involve a complex interplay of different inflammatory mediators     and cell types. It has been suggested that locally released inflammatory mediators pass from     the lungs into the bloodstream following ARDS, triggering systemic inflammation. Conversely,     it is possible that severe systemic inflammation may lead to ARDS by an influx of     inflammatory mediators from the bloodstream to the lungs. However, the time course and the     possible pathways for this transmission of disease have yet to be established.      Investigators hypothesize that:        1. Primary systemic inflammation is followed by a secondary pulmonary inflammatory response        2. Primary pulmonary inflammation is followed by a secondary systemic inflammatory response        3. Both primary and secondary inflammatory responses are characterized by the appearance of          pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins          (termed 'lectins')        4. The inflammatory response is most pronounced in the primary afflicted compartment.   "
105421|NCT01906216|"     This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and     safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced     hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the     prognostic factors that influence the survival.      Data on the efficacy and safety of sorafenib in combination with TACE in patients with     advanced HCC are lacking. Because in western countries, advanced HCC is considered as a     contraindication for TACE treatment. However, clinical practice patterns differ markedly     between Asia and western countries: in Asia TACE is performed in selected advanced HCC     patients. We consider sorafenib combined with TACE could achieve better survival benefit than     sorafenib alone in selected advanced HCC patients.   "
105422|NCT01906203|"     Prospective cohort, monocentric non-randomized and interventional clinical study in ICU     assessing the evolution of body composition using bioelectrical impedance analysis.   "
105423|NCT01906190|"     This clinical study will be performed in subjects aged 12-60 years old enrolled in     NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the     immune response of influenza vaccine up to 24 months after vaccination.   "
105424|NCT01906177|"     The primary objectives of this pilot clinical study include:        -  Evaluate clinical outcomes and quality of life on patients who received Vanguard PS          Total Knee in Korean population        -  Evaluate safety of Vanguard PS Total Knee in Korean population   "
105425|NCT01906164|"     This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally     administered ALS-008176 in healthy volunteers.   "
105426|NCT01906151|"     The purpose of the study is to determine the relationship of the intraocular pressure     patterns recorded during 2 sessions using Triggerfish, before and after elective laser     peripheral iridotomy in angle closure glaucoma patients   "
105427|NCT01906138|"     The purpose of the study is to determine the relationship of the intraocular pressure     patterns recorded during 2 sessions using Triggerfish, before and after elective laser     peripheral iridotomy in angle closure glaucoma patients.   "
105761|NCT01901718|"     Chronic pain patients who experience breakthrough pain in the background of controlled     persistent pain with opioids will be followed for 3 months in order to assess the safety and     titration trends in the clinical practice setting of a novel fentanyl sublingual spray     (Subsys™) for the treatment of breakthrough pain.   "
105428|NCT01906125|"     This study is intended to establish the equivalence of 2 formulations to the intended final     market product. The formulations to compare are the capsule given to patients in the phase I     and II studies and the capsule that is being administered to the patients in the phase III     trials. Both capsules will be compared to the intended final market capsule. The comparison     will be performed looking at the pharmacokinetic parameters that define the rate and extent     of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing     these parameters calculated after a single 125 mg dose of the 3 capsules identifying like     that if there are significant differences between these 3 formulations.   "
105429|NCT01906112|"     The purpose of this study is to determine benefits of surgery for the primary in patients     with breast cancer stage IV in randomized controlled study.   "
105430|NCT01906099|"     This randomized cross-over study was designed to investigate the effects of legume enriched     diet consumption on cardiovascular risk factors among first degree relatives of diabetic     patients.   "
105431|NCT01906086|"     The aim of this randomized cross-over study was to determine the effects of legume     consumption on adiponectin and inflammatory factors among first degree relatives of diabetic     patients   "
105432|NCT01906073|"     Today, patients with cancer pain in need of opioids for moderate to severe pain get     long-acting morphine twice a day and morphine tablets taken on demand in addition. This     procedure might be based on the assumption that cancer pain is persistent, although the     evidence to support whether this assumption applies to all cancer patients is lacking. Some     cancer patients might not need a fixed dose of long-acting morphine.      Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an     opioid on demand when pain occurs.      A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl     nasal spray taken on demand, showed that this treatment was apparently feasible and safe for     these patients.      This approach is studied further in NFCP-II. The participants will be treated with     rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary     outcome will be patient satisfaction.      The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment     phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day.     After 10 days of treatment there is a crossover and the opposite drug is used for the same     participant. Morphine tablets can be taken on demand in all phases of the study.      The participants will meet the investigator at inclusion, at the crossover and at the end of     treatment. During the study, a diary is filled in by the participants every morning.     Questions about pain and side effects are answered. Satisfaction is measured at the crossover     and at end of treatment while preference is measured at the end of treatment.   "
105433|NCT01906060|"     The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical,     Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a     tracheal tube. This intubating laryngeal airway device (ILA) is already commercially     available and worldwide certificated (CE 0482), but data about the success rates of blind     intubation via this device in adult patients are lacking. Success rates of blind intubations     with the non-self-inflating device range between 57 and 97%.      Although the self-inflating disposable Air-Q device is certified for blind intubation, the     success rate and rate of adverse events associated with this procedure have not been     published so far. In a study comparing adverse events of conventional intubation with blind     intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and     cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot     study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported     dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One     study using the self-pressurised disposable Air-Q for ventilation of children showed broncho-     or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were     reported in 1%.      This data suggests that the rate of adverse events using the Air-Q supra-glottic device are     comparable to other devices such as LMA.        -  Trial with medical device   "
105434|NCT01906047|"     We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis     bronchiectasis outcome.   "
105435|NCT01906034|"     Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in     impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk     factors are age-related decreases in balance and strength / power performance as well as     cognitive decline. Additional studies are needed to develop specifically tailored exercise     programs for older adults that can easily be implemented into clinical practice. Thus, the     objective of the present trial is to assess the effects of a fall prevention program that was     developed by an interdisciplinary expert panel on measures of balance, strength / power, body     composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older     adults. Additionally, the time-related effects of detraining are tested.      Methods/Design Healthy old people (N = 66) between the age of 65 to 80 years will participate     in this trial. The testing protocol comprises tests for the assessment of static / dynamic     steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive     balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e.,     perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip     strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test). Further, body     composition will be analysed using a bioelectrical impedance analysis system. In addition,     questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of     Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk     determinants (i.e., Fall Efficacy Scale - International) will be included in the study     protocol. Participants will be randomized into two intervention groups or the control /     waiting group. After baseline measures, participants in the intervention groups will conduct     a 12-week balance and strength / power exercise intervention 3 times per week, with each     training session lasting 30 min (without warm-up and cool-down). One intervention group will     complete a supervised training program (2x supervised training per week / 1x home training     per week), while the other intervention group will complete a training after the same     protocol that is home-based (3x home training per week) and controlled by phone calls every     two weeks. Post-tests will be conducted right after the intervention period. Additionally,     detraining effects will be measured 12 weeks after program cessation. The control group /     waiting group will not participate in any specific intervention during the experimental     period, but will receive the extensive supervised program after the experimental period.      Discussion It is expected that particularly the supervised combination of balance and     strength / power training will improve performance in variables of balance, strength / power,     body composition, cognitive function, psychosocial well-being, and falls self-efficacy of     older adults. In addition, information regarding fall risk assessment, detraining effects,     and supervision of training will be provided. Further, training-induced health-relevant     changes, such as improved performance in activities of daily living, cognitive function, and     quality of life, as well as a reduced risk for falls may help to lower costs in the health     care system. Finally, practitioners, therapists, and instructors will be provided with a     scientifically evaluated, feasible, safe, and easy-to-administer exercise program for fall     prevention.   "
105436|NCT01906021|"     Background:      - Ablation is a procedure that heats tumor tissue to a high temperature to destroy it.     Doctors perform this procedure by putting a probe in the tumor. This delivers heat to the     site. Currently, doctors tell what area is heated by using the probe s manufacturer     estimates. These estimates are imprecise. Doctors insert small needles to measure the     temperature around the area being heated. Doctors also perform scans of the area, but these     cannot show which tissue has been heated and which has not. Right now, only contrast scans     can show that. But researchers have developed software that uses images from routine scans to     create a temperature map. They want to test the software to see if doctors can monitor the     procedure without using more needles and without contrast scans.      Objectives:      - To test software that might help doctors perform ablations better in the future.      Eligibility:      - People over 18 years of age already scheduled to have an ablation.      Design:        -  Participants will be screened with a medical history.        -  Participants will visit the clinic for their already-scheduled ablation. The doctor will          use the study software to      analyze the temperature in the area being heated. The software will not come into contact     with a participant s body.      - Participants will undergo scans that are necessary for the procedure, but one or two     additional scans may be done as part of this study.   "
105437|NCT01906008|"     The goal of this clinical research study is to learn if minocycline can reduce numbness,     pain, and/or loss of motor function in patients with colorectal cancer. In this study,     minocycline will be compared to a placebo.      The study doctor can explain how the study drug is designed to work.      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
105438|NCT01905995|"     Electrid activity of the basal ganglia will be recorded with an implantable deep brain     stimulation device (supplied by Medtronic Inc).      Study hypothesis is that these activities differ according to what the patient does, i.e. are     different during gait and speech.   "
139733|NCT01455662|"     There is a correlation between hospital mortality and changes in markers of tissue perfusion,     lactate, and venous oxygen saturation and carbon dioxide gradient.   "
105440|NCT01905969|"     Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has     improved disease free time and survival. However, there are still considerable number of     patients experience relapse even after adjuvant chemotherapy. In an attempt to select     patients who really benefit the postoperative adjuvant chemotherapy, we have identified     potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by     immunohistochemical validation. In the present study, we further validate the significance of     the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be     determined immediately after surgery.   "
105441|NCT01905956|"     The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several     studies demonstrating their efficacy, we are conducting this study to look into the efficacy     and safety of this novel combination of three fibres, in appetite regulation.   "
105644|NCT01903265|"     TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have     shown promise as a treatment of fibromyalgia, but the drug required new formulation     technology for bedtime use. The present trial was designed to assess the safety and efficacy     of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.   "
105442|NCT01905943|"     This multicenter, open-label, single-arm study will evaluate the safety and efficacy of     obinutuzumab alone or in combination with chemotherapy in participants with previously     untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). Participants will     receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with     chemotherapy at the investigator's discretion. Each participant will be followed until 30     months after the last participant has been enrolled. Total length of the study is anticipated     to be approximately 5 years.   "
105443|NCT01905930|"     On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM     Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a     degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy     for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck     pain, or myelopathy due to a single-level abnormality localized to the disc space, and     manifested by at least one of the following conditions confirmed by radiographic imaging (CT,     MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of     osteophytes), and/or visible loss of disc height as compared to adjacent levels.      The purpose of this post-approval study is to evaluate the long-term (7 year) safety and     effectiveness of the PCM Cervical Disc.   "
105444|NCT01905917|"     The primary hypothesis tested in this randomized control trial is that a tele-rehabilitation     intervention involving video-conferencing with a therapist and use of wearable monitoring     devices in the first three months after stroke results greater functional recovery using the     Jette Late Life Functional and Disability Instrument (LLFDI) (primary outcome) among stroke     at three months survivors compared to usual care.      The secondary hypotheses tested in this randomized control trial are that a     tele-rehabilitation intervention involving video-conferencing with a therapist and use of     wearable monitoring devices in the first three months after stroke results in:        -  Functional recovery using the LLFDI at 6 months,        -  Functional recovery using gait speed, 2-minute walk test and Shah modified Barthel Index          at 3 and 6 months,        -  Greater contact time with a therapist at 3 & 6 months,        -  Better balance at 3 & 6 months,        -  Better self-report health-related quality of life at 3 & 6 months,        -  Decreased health service utilization at 3 & 6 months,        -  Reduced caregiver burden at three months survivors compared to usual care at 3 & 6          months.   "
105445|NCT01905904|"     The purpose of the study was to investigate the effects of different doses of sevoflurane     used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and     recovery profiles   "
105446|NCT01905891|"     The purpose of this study is to correlate pathological features from specimens in order to     determine if this new molecular diagnostic technique can be used to detect risk of skin     cancer.   "
105447|NCT01905878|"     DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm.     This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major     proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight     Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a     drug that consists of serin protease enzyme, suspected that the mechanism of action of     lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded     that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic     effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic     of this drug. As a pilot study, the aim of this study is to evaluate biological half life of     DLBS1033.   "
105448|NCT01905865|"     Background:      - Parents of a child with an undiagnosed medical condition face a lot of uncertainty. They     may not know how to take care of their child or how the illness will affect their family     life. Researchers want to study how these parents cope with and adapt to their child s     condition in light of this uncertainty. Being uncertain can make it hard for parents to     adapt. But it also might give them hope. Researchers want to study how uncertain the parents     think their situation is and how that affects the way they think they can cope. Personality     traits, like being able to handle uncertainty and being resilient, might also affect coping.      Objectives:      - To understand how having a child with an undiagnosed illness affects the way their parents     think they can cope.      Eligibility:      - Adults with a child who has a medical condition that has not been diagnosed for at least 2     years and involves at least 2 parts of the body.      Design:        -  Participants will answer survey questions for about 30 minutes. The questions are about          their thoughts and feelings about having a child with an undisclosed illness.        -  Participants can take the survey on paper or online.   "
105454|NCT01905787|"     The purpose of this study is to take advance of the presence of two different cohorts of SCA     patients in one country, the first group included SCA patients from Bedouin Arab origin that     lives in Israel for more than one century and originally comes from African countries or     Saudi Arabia, those patients lives in north east Israel and are treated at the Hematology     Unit of the Emek Medical Center, the second group are SCA patients from African origin that     come to Israel in the last decades and belong to original African population, this group     receive treatment at the Pediatric Hematology Unit, Dana Children's Hospital, Ichilov Medical     Center. A third group is a cohort of SCA patients treated at Schneider Children's Hospital     Hematology Unit. Those patients belong also to the Israel Arab population and patients from a     village that African Muslims live for many years. The characteristics of the three groups     will be compared to the characteristics of a fourth group, a cohort of Afro-American SCA     patients that are followed up and treated at the Pediatric Hematology Unit, Detroit     Children's Medical Center, Detroit, Michigan, USA.   "
105457|NCT01905748|"     Acute Migraine attacks can be related to vascular or coagulation activation. Previous studies     found relative high incidence of prothrombotic events in Migraine. The present study intends     to assess the coagulation system and activation in patients with Migraine during steady state     phase and at the beginning of attacks and after 72 hours. A control group of patients with     another acute neurologic event like convulsions will be also studied. Patients will be at     pediatric age and teenagers.   "
105458|NCT01905735|"     the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic     medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.   "
106264|NCT01895114|"     The purpose of this study is to help determine whether cystatin C is a more sensitive     laboratory measurement for renal function in cirrhotic patients.   "
105449|NCT01905852|"     Background:      - Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces     heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of     ways, including replacing a heart valve.      Objectives:      Researchers want to study fibrosis in the heart. A sub-study will test whether heart function     and blood supply improve after a valve replacement.      Eligibility:      - Adults at least 18 years old with aortic stenosis.      Design:        -  Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their          heart. This uses magnets, radio waves, and computers to produce detailed pictures of the          heart.        -  After this visit, participants will have their aortic valve procedure at the the          Washington Hospital Center. A hospital team will contact participants for 1 year by          phone or email. This follow-up will consist of 15 minutes of questions about the          participant s health status.        -  Some participants will join a sub-study.        -  They will be given an additional medication to evaluate the blood supply of the heart.        -  They will visit a clinic for 1 day for an MRI of their heart, as part of the main study,          prior to the aortic valve replacement.        -  After they have their valve replaced at the hospital, they will return to the clinic for          another MRI.        -  They will have the same follow-up as in the main study.   "
105450|NCT01905839|"     Background:      - Parkinson s disease (PD) affects half a million Americans, causing slow movements, tremors,     stiffness, and trouble walking. Currently, these symptoms are measured by physical exam, but     this is unreliable and requires an office visit. Researchers want to study a different way to     measure PD symptoms, using a home-testing machine called a QMAT device. It can test how     quickly someone moves doing different tasks. Researchers will study how this testing compares     to physical exam testing and whether the device can detect changes in PD symptoms over time.      Objectives:      - To see if a home testing device can be used to evaluate Parkinson s disease symptoms.      Eligibility:      - Adults at least 18 years old with PD.      Design:        -  Participants will have about 22 clinic visits over 5 years. Each visit will take up to 3          hours. Visits will be scheduled along with visits for another study.        -  At visit 1, participants will learn to use the QMAT device and how to send testing          information to the clinic by computer. The device has a computer screen, some buttons,          and some pegs. Participants will get a device to take home and any accessories.        -  Participants will learn 2 QMAT tests. For one, they will press keys as fast as possible.          For the other, they will move pegs into holes. The tests will take a total of about 20          minutes.        -  Participants will take both tests at home, 2 times on the same day each week, once          before their medication, once after.        -  A study coordinator will monitor the participant s computer data and discuss the at-home          testing at the clinic visits.   "
105451|NCT01905826|"     Background:      - GATA2 deficiency is a genetic disorder that can cause problems with a person s immune     system and other body systems. Some people who have this disorder develop few problems from     it. Others can have a wide range of health problems, from skin problems, to hearing loss, to     cancer. These problems can happen at any age. Researchers want to study GATA2 deficiency to     better understand what types of health problems it can cause, and why it causes problems in     some people but not others, and at different ages.      Objectives:      - To improve understanding of GATA2 deficiency so there can be better diagnostic tests and     treatments in the future.      Eligibility:      - People 2 years of age or older who have a GATA2 gene mutation or certain health conditions     that are commonly seen in people with this mutation and their blood relatives.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected to see whether participants have the GATA2 genetic mutation.          Several other tests may be recommended, but participants can decline to take them.        -  Participants will be eligible to receive standard care for GATA2 deficiency through this          protocol. They may be eligible for other clinical trials at the National Institutes of          Health as well.        -  Participants will have regular study visits once a year to evaluate their GATA2          deficiency. Participants will take part in the study for at least 3 years and up to 15          years. At these follow-up visits, participants will fill out a questionnaire and take a          physical exam and blood tests. Other tests may be performed as needed.   "
105452|NCT01905813|"     The study will be conducted in three parts. Part 1 is a dose escalation phase to determine     the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated,     pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and     itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a     tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3     will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib     (INCB039110) in subjects with relapsed/refractory B-cell malignancies.   "
105453|NCT01905800|"     Benign paroxysmal positional vertigo (BPPV) represents the most common cause of labyrinthine     vertigo with a lifetime prevalence of 2.4 percent. Onset is most common between the fifth and     seventh decades of life. The disease can be a major handicap for the affected patient, and     causes a great expense for society. The traditional manual treatment with repositioning     maneuvers has greatly improved the possibilities for treatment of BPPV the last decade.     However some patients are still difficult to diagnose and treat, and there are some who for     health reasons cannot undergo traditional manual treatment. In this perspective there is a     demand for a reliable, effective and precise method to treat all semicircular canals for the     differentiated patient groups, and the techniques are under continuous development.   "
105455|NCT01905774|"     Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal     iron absorption. Renal function caused by Iron overload was studied in a previous study and     shows principally tubular disfunction. In this previous study the Iron chelator used was     Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by     the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to assess     the renal function in Thalassemia Major patients treated with this new oral iron chelator and     compare the results with our previous study.   "
105456|NCT01905761|"     To systematically follow patients seen at the University of Minnesota's Lifestyle Medicine     Program for Weight Management.   "
107443|NCT01879735|"     We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer     11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and     patients with cholestatic disorders.   "
105459|NCT01905722|"     The overarching goal of this program project grant is the development of technologies that     lead to new methods for studying, detecting, and treating type 2 diabetes, and their     integration with hypothesis-driven diabetes research projects.      Project 4 of the grant, led by Dr. Craig Malloy at UTSW, will develop and apply new     technology in MRI to test core hypotheses about the development of insulin resistance in     people. The long-term goal is to develop technology to monitor metabolism in skeletal muscle,     brain and the liver using magnetic resonance imaging (MRI) and magnetic resonance     spectroscopy (MRS) in a 3 Tesla and 7 Tesla MRI scanners. These advanced imaging methods     allow researchers to take pictures of the inside of the body and to measure metabolism as it     occurs in the MRI scanner. Standard clinical MRI for medical diagnosis and treatment is     performed in a 1 Tesla or 3 Tesla MRI scanner.      A primary goal of the 7 Tesla research program is to develop a group of protocols for     investigating specific metabolic pathways in adipose (fat) tissue, skeletal muscle and the     liver. This study is being done to improve methods of imaging and measuring molecules in a 3     Tesla or 7 Tesla scanners.   "
105460|NCT01905709|"     The objective of this study is to provide treatment with Fecal Microbiota Transplantation     (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has     been shown that good bacteria (like that found in the stool from a healthy donor) attack     Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile     - and they attach to the surface of the colon lining, which prevents the Clostridium     difficile toxin (poison) from attaching.      FMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of     the patient with CDI during a colonoscopy.      The method used to deliver the FMT will depend on individual characteristics of the subject     and is at the discretion of the treating physician. FMT may be administered by the following     methods.        -  Colonoscopy: This method allows full endoscopic examination of the colon and exclusion          of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have          an impact on subject's treatment or response to therapy.        -  Sigmoidoscopy: This method still allows infusion of the stool into a more proximal          segment of the colon than an enema, but may not require sedation. This method may be          beneficial in subjects who are elderly or multiparous and who may have difficulty          retaining the material when given as enema. Sigmoidoscopic administration eliminates the          additional risks associated with colonoscopy in subjects who may not have a clear          indication for colonoscopy.        -  Retention enema: This method may be preferable in younger subjects who have already had          recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in          subjects with significant co morbidities and may not tolerate endoscopy.      The physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL,     through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of     colonoscopic delivery, the material will be delivered to the most proximal point of     insertion.      The subject is encouraged to retain stool for as long as possible.   "
105461|NCT01905696|"     Nitric oxide is believed to contribute to regulation of blood flow by its selective binding     to circulating hemoglobin (forming S-nitrosohemoglobin, SNO-Hb) and release in a     PO2-dependent manner. This study is designed to test that hypothesis by measuring the effect     of hypoxia and exercise on forearm blood flow before and after depletion of SNO-Hb using oral     N-acetylcysteine.   "
105462|NCT01905683|"     The purpose of this study is to determine whether injections of Botulinum toxin type A into     muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age     2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness     (spasticity) due to cerebral palsy.   "
105463|NCT01905670|"     The study is intended to demonstrate the safe implant of small receiver-electrodes into the     endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac     resynchronization therapy in heart failure patients.   "
105464|NCT01905657|"     This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants     with non-small cell lung cancer (NSCLC) who had experienced disease progression after     platinum-containing systemic therapy. Participants were assigned randomly to receive either     pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel     75 mg/m^2 Q3W. This study used an adaptive trial design so that the total number of     participants randomized depended upon demonstration of sufficient objective responses at an     interim analysis.      Based on the positive outcome of the Overall Survival (OS) analysis, Protocol Amendment 12     (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel     and experienced disease progression, to be permitted to crossover to receive pembrolizumab 2     mg/kg Q3W as long as Inclusion/Exclusion criteria were met. These participants were     participating in the Cross-Over Phase.      The primary study hypotheses are that pembolizumab prolongs OS and Progression-free Survival     (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by     independent radiologists' review in previously-treated participants with NSCLC in the     strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in     participants whose tumors express PD-L1 compared to docetaxel.   "
105465|NCT01905644|"     The main objective of this study is to compare post partum rates of anal sphincter rupture     (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears     between two groups: (1) women who are screened just after delivery by performing a perineal     ultrasound versus a similar group of women who did not receive screening. This study was not     designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal     surgical procedures in each arm.   "
105466|NCT01905618|"     This study compares two methods of teaching the 5As (Ask, Advise, Assess, Assist, Arrange)     for tobacco dependence treatment to medical students: 1) traditional medical education (TE),     and 2) multi-modal education (MME). The MME arm builds upon the traditional curriculum at the     medical school by providing a web-based instructional program, a role play, preceptor     training, and a booster session. The hypotheses are that MME will outperform TE on observed     5As counseling skills on the Objective Structured Clinical Exam (OSCE); and MME will     outperform TE on self-reported 5As counseling skills.   "
105777|NCT01901510|"     This study first is designed to see what dose of indigo carmine ingested orally mixed with     the standard colonoscopy prep is needed to provide adequate staining of the right colon. It     then will use this adequate staining concentration of Indigo Carmine to study whether this     dye will increase the detection of polyps during colonoscopy.   "
105467|NCT01905605|"     Sensory gating is defined as the automatic process of inhibiting brain response to repeated     auditory sounds. Infants who brains respond similarly to two identical sounds presented about     1/2 second apart are more likely to have later problems with attention than infants who     suppress response to the second sound. This study will examine whether providing a     nutritional supplement, phosphatidylcholine, for two months in infancy will result in an     increased likelihood of developing more robust sensory gating.   "
105468|NCT01905592|"     The purpose of this study is to compare progression-free survival (PFS)in patients with     advanced/metastatic breast cancer who have a BRCA gene change when treated with niraparib as     compared to those treated with physician's choice   "
105470|NCT01905566|"     Objectives: To compare the effects of clopidogrel versus ticagrelor on atherosclerotic plaque     inflammation using serial FDG PET/CT imaging of carotid artery and ascending aorta.      Hypothesis: Thrombosis and inflammation are tightly linked rather than separate entities.     Therefore, P2Y12 receptor inhibitors may have an anti-ischemic effect by inhibiting plaque     inflammation, and ticagrelor may be superior in efficacy to clopidogrel.   "
105471|NCT01905553|"     To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to     administration under fasted conditions.   "
105472|NCT01905540|"     This study will evaluate the relative bioavailability of the new SSP-004184SS capsule     formulation compared to the original SSP-004184AQ drug plus excipients formulation.   "
105473|NCT01905527|"     This is a Phase IV study to compare the current level of MS LifeLines ® (MSLL) services     (face-to-face nursing visits and phone contacts) with customized MSLL services, to determine     the optimal services to enhance medication adherence and treatment persistence with Rebif ®     subcutaneous three times a week.   "
105474|NCT01905514|"     Nonadherence to immunosuppression is a leading cause of late graft rejection, chronic     rejection and graft failure and it is regarded as a preventable cause of graft loss after     solid organ transplantation. The purpose of this study is to evaluate whether mobile     application for drug medication can enhance the drug adherence rate.   "
105475|NCT01905501|"     This study aimed to evaluate the possible protective effect of anesthetic technique     balanced(with sevoflurane) compared with total intravenous anesthetic technique     (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect     in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap     during transfer to receiving area. The investigators will evaluate the continuous flap tissue     oximetry and the level of biochemical markers.   "
105476|NCT01905488|"     Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve     system to prevent retrograde blood flow to the brain. Anatomical studies revealed that     bicuspid or tricuspid valves were located in both jugular veins 2 cm above the     subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence     (IJVVI) may result in retrograde flow which leads to brain congestion and increase of     intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been     reported to be associated with transient global amnesia (TGA), cough syncope, exertional     headache, transient ischemic attack, and air embolism. Demographic data are associated with     the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male     gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI     including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension.     Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery     because of its significant benefits such as smaller incision, less severe postoperative pain,     less intraoperative bleeding, and shorter hospital stay compared to traditional radical     prostatectomy. The patients undergoing RLP are mostly over 60 years old, have neurologic,     cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg position most of     the time during surgery, which could cause increases in intra-abdominal and intrathoracic     pressure.   "
105477|NCT01905475|"     The purpose of this study is to investigate the effects of POL6326 (CXCR4 antagonist) as a     stem cell mobilizing agent, on cardiac function and infarct size and on safety and     tolerability, in patients with reperfused ST-Elevation Myocardial Infarction (STEMI).   "
105478|NCT01905462|"     This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of     gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with     last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and     90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with     LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the     Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the     UK, will be analysed in this study.   "
105479|NCT01905449|"     Children with speech sound disorders will receive speech therapy using real-time images of     the tongue from ultrasound. These images will be used to cue the child to change the tongue     position when producing speech sounds.   "
105488|NCT01905332|"     This study's aim is to validate a parent-completed brief literacy screening tool (Early     Literacy Screener) at the 4 year well child check using the Get Ready to Read- Revised     screening tool as a gold standard. Four year old children who fall below the cutoff score for     the GRTR-R will be randomized to either receive current standard of care (control group) or a     referral to receive a 6 month home based literacy promoting program (intervention group).     After 6 months, both groups will be retested using the GRTR-R. The hypothesis is that the     change in raw scores on the GRTR-R in the intervention group after 6 months will be greater     than the change in raw scores in the control group.   "
105489|NCT01905319|"     Aims of the study:        -  to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical          subtypes in Estonia for the years 1998-2000;        -  to examine the course and short-term clinical outcome of JIA.      Method: a prospective population-based study carried on in 14 counties of Estonia   "
105490|NCT01905306|"     This clinical study has the objective to compare the radiographic evaluations after 3 years     of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly     using the methodology for computer guided implant planning with software polyvalent or free     hand implants placement.   "
105506|NCT01905085|"     Indirect calorimetry is valuable in determining resting energy expenditure in infants,     children and adults. This measure will estimate the number of calories needed per day under     resting conditions.      Adding physical activity measures will help estimate total energy requirements in     individuals. With the rise in obesity, numerous programs of prevention are being developed.     Being able to characterize carefully energy intake and energy expenditure is one of the     challenges of most of these initiatives.   "
105645|NCT01903252|"     The purpose of this research study is to compare the medication TP05 to the medication     Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and     tolerability of TP05. This study will investigate whether TP05 is as good as (non-inferior     to) Asacol™.   "
106491|NCT01892137|"     The main purpose of this trial is to demonstrate the predictive value of the clinical     diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using     histopathological examination as the standard.   "
105480|NCT01905436|"     Approximately 5,200 people will participate per year. The study population will include     females and males over 5 years of age who live in filariasis and onchocerciasis endemic     areas. Subject selection will not be based on health status.      Two sites will be studied, and each study will last for 4 years. Participants will be studied     only once in cross-sectional surveys. Some subjects may be included in more than one annual     population survey, but this is not a longitudinal study.      Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic     filariasis and onchocerciasis, and investigators will compare the impact of these MDA     schedules on soil transmitted helminth infections. MDA will be administered by others     (Liberian Ministry of Health or Liberian Institute of Biomedical Research).      The investigators will test the hypothesis that semiannual mass drug administration (MDA) is     superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for     control of soil transmitted helminth (STH) infections.        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug          administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.        2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug          administration (MDA) for elimination of onchocerciasis in these populations.        3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)          infection in these populations.   "
105481|NCT01905423|"     Approximately 3,500 people will participate per year. The study population will include     females and males over 5 years of age who live in filariasis endemic areas. The study will be     performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4 years.     Participants will be studied only once in cross-sectional surveys. Some subjects may be     included in more than one annual population survey, but this is not a longitudinal study.     Purpose of the study is to evaluate different mass drug administration (MDA) regimens for     lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth     infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this     study may enhance efforts to control and eliminate these important neglected tropical     diseases.      The investigators will test the hypothesis that accelerated mass drug administration will be     superior to annual MDA for elimination of lymphatic filariasis and for control of soil     transmitted helminth infections (STH):        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug          administration (MDA) for elimination of lymphatic filariasis (LF).        2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)          infection in these populations.   "
105482|NCT01905410|"     VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity     inhibiting GlyT2 and 5HT2A simultaneously. There have been many efforts to develop     single-target selective drugs to treat pain, but usually unsuccessful due to the lack of     efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected     to have a dual-target activity, demonstrated having a synergism between GlyT2 and 5HT2A     antagonistic activities to maximize an antinociceptive effect in the in vivo animal models.     Now the investigators are developing VVZ-149 as an IV injection to treat post-operative pain.      The primary objective of this study is to evaluate a safety, tolerability and pharmacokinetic     properties of VVZ-149 injection with placebo in healthy male volunteers. This Phase 1 study     consists of a randomized, double-blind, placebo controlled, single and multiple ascending     dose (SAD & MAD) escalation clinical trials.   "
105483|NCT01905397|"     The purpose of this study is to compare the rate of surgical site infection between     traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days     after surgery and at the first clinic visit after surgery.   "
105484|NCT01905384|"     The purpose of this study is to compare the rate of long-term stent failure, defined as need     for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of     inoperable malignant distal bile duct obstruction.   "
105485|NCT01905371|"     This is an NIH Pilot Clinical Trial Grant designed to provide data to permit the rationale     design of a subsequent efficacy study. The purpose of this project is to determine the     potential benefit of amphetamine combined with physical therapy in enhancing motor recovery     in patients admitted for inpatient rehabilitation between 10 and 30 days after hemispheric     ischemic stroke. The study hypotheses are: 1, The addition of treatment with d-amphetamine     will result in at least a 12.6 point improvement in the Fugl-Meyer motor score 3 months after     stroke. 2, There will be no clinically significant increase in the frequency of serious     adverse events associated with treatment with d-amphetamine which would preclude further     testing.   "
105486|NCT01905358|"     The purpose of this prospective data collection is to track patients who are treated at HSS     who are confirmed with knee osteoarthritis. The registry will collect prospective patient     related and functional outcomes (including use of assistive devices), medication use and     imaging data on patients with confirmed osteoarthritis, and the effect of different medical     interventions that include PRP, Synvisc / Orthovisc /Euflexxa, bracing, suggested exercises,     supplements, and diet. Information from the data collection will be used to compare outcomes     of non-surgical alternatives with the end point being knee arthroplasty. The information     results will enhance our knowledge of the long-term efficacy and effectiveness of     non-surgical interventions intended to treat the progression of osteoarthritis.      Hypotheses:        -  Different non-surgical interventions such as PRP, Synvisc®, Orthrovisc®, Euflexxa,          bracing, physical therapy, and a prescribed combination of exercise, diet, and          supplements will demonstrate statistically significant differences in patient pain and          functional outcomes compared to usual interventions including use of NSAIDs,          corticosteroid injections, and use of assistive devices such as canes.        -  Non-operative interventions for knee osteoarthritis will be associated with different          rates of breakdown of articular cartilage and different rates of progression of          osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?        -  Education about available non-operative treatment methods may change time the end point          of total or partial knee replacement for patients with knee osteoarthritis of varying          severity.        -  Different non-operative interventions will be associated with different times to total          or partial knee arthroplasty in patient with knee osteoarthritis of similar severity.        -  An electronic data capture system (EDC) for osteoarthritis patients will improve patient          care and patient outcomes.   "
105487|NCT01905345|"     Randomised training intervention.      Influence of consecutive training regime on the impact of the myonuclear domain and satellite     cell      Sarcopenia      Despite that the muscle mass can be positively influenced by training, the loading with high     weights and/or to the total exhaustion is for many old persons not possible.      Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a first     phase by endurance training, in order to promote a more effective muscle growth in a second     phase by resistance exercise.   "
105505|NCT01905098|"     The purpose of this study is to determine the impact of sauna use on polychlorinated     biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety,     feasibility, and tolerability, and effects on quality of life and wellness. We hope to     determine if there is a link between lower PCB levels in blood and sauna use.   "
106492|NCT01892124|"     American Indians (AIs) living in the Northwest have very high rates of diabetes, obesity,     tobacco use, depression, and other risk factors associated with cardiovascular disease.     Depression and diabetes have a pernicious effect on CVD risk and susceptibility. This study     seeks to build upon the success of the 1-month, 5-session motivational interviewing (MI) CVD     prevention component of the həli?dxw Project (aka Healthy Hearts-originally funded under     RFA-HL-06-002; U01 HL HL087322-05). həli?dxw successfully culturally adapted MI for CVD     prevention for AIs, trained AIs to implement the intervention, and conducted a preliminary     feasibility and efficacy trial. Initial results indicated that participants enthusiastically     embraced the MI component of the program; however, observations of the counselors, survey     data, and feedback from participants suggest that depressive symptomatology served as a     barrier to achieving CVD preventive behaviors and desired outcomes; and, that more time and     attention to underlying depressive symptomatology may enhance motivation and CVD prevention     behaviors, particularly among AIs with pre-diabetes and Type 2 diabetes. Building upon solid     preliminary CVD epidemiological data, preliminary acceptability and feasibility of utilizing     an MI approach, and motivated by the need to address elevated depression and diabetes     profiles from the həli?dxw study, the investigators will develop a 3-month, 10-session     MI-based cognitive-behavioral-adherence (MI-CBT-CVD) treatment program to address underlying     depressive symptomatology, activate CVD prevention behaviors, and decrease BMI and CVD risk     behaviors among 50 pre-and recently diagnosed diabetic AIs at risk for CVD. The study     proposes three innovative and significant aims. First, in line with community-based     participatory (CBPR) principles and pre-established indigenous research protocols with the     tribal community, the investigators will conduct formative research to develop the MI-CBT-CVD     intervention. Second, the investigators will conduct a pilot randomized two-group,     single-site waitlist-controlled clinical trial of a 10-session, 3-month MI-based     cognitive-behavioral treatment for CVD prevention (MI-CBT-CVD) among 50 pre-and recently     diagnosed diabetic AI adults with depressive symptomatology and who are also at risk for CVD.     Assessments will be conducted at pre and post intervention and at 6-months (3 month     follow-up). Third, the investigators will disseminate the findings to the tribe as well as     research outlets and prepare an RO1 to conduct a full-scale RCT should the pilot intervention     be efficacious, acceptable to the community, and feasible. The primary objectives will be to     determine the effect of the proposed culturally-grounded behavioral intervention program on     (a) reducing weight as measured by BMI (7-10% reduction in BMI); (b) decreasing depressive     symptomatology; (c) increasing physical activity; (d) decreasing sedentary activities; (d)     increasing healthful food habits; and (e) improving biomedical outcomes (e.g., blood lipid     profiles, glucose, hemoglobin A1C, and blood pressure). The intervention will be culturally     relevant and utilize existing Native resources and personnel wherever possible.   "
105491|NCT01905293|"     The portion size of foods has been identified as an important determinant of energy intake in     children. It remains to be determined to what extent child weight status and the relative     reinforcing value of food may interact with the obesogenic food environment to affect energy     intake. The primary aim of this study was to compare energy intake at a meal in normal-weight     and obese children when the portion size of palatable, energy-dense foods and a     sugar-sweetened beverage was systematically increased. We hypothesized that increasing the     portion size of all foods and the beverage at a meal will lead to a significant increase in     energy intake in both normal-weight and obese children. Obese children, however, will show a     significantly greater increase in energy intake than will normal-weight children. A second     aim of this study was to test if children's response to increases in portion size was     affected by how reinforcing they find food to be. We hypothesized that, when controlling for     BMI, children who find food very reinforcing relative to nonfood alternatives will show a     significantly greater increase in energy intake than will children who find food less     reinforcing.   "
105492|NCT01905280|"     The purpose of this study is to compare the clinical and histologic outcomes for acellular     dermal matrix and a nonresorbable membrane to determine if either provides a significant     therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge     width between the two treatments.   "
105493|NCT01905267|"     The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a     research study examining how mindfulness can help teenagers stay healthy and prevent     depression relapse.   "
105494|NCT01905254|"     Recent, research has focused on the evaluation of non-invasive methods for the assessment of     liver fibrosis in patients with chronic liver disease. Among these methods, transient     elastography is the most promising. The method has been investigated mainly in patients with     viral hepatitis. Several studies have shown, that the optimal cut-off value of TE for     detection of liver cirrhosis by transient elastography is highly dependent on the aetiology     of the underlying liver disease. Only a few studies have evaluated the value of transient     elastography for patients with autoimmune liver disease and here primarily patients with PBC     and PSC. For patients with autoimmune hepatitis the data is limited. We prospectively     investigated the diagnostic accuracy of TE in autoimmune hepatitis compared to liver     histology with and without inclusion of the macroscopic appearance using mini-laparoscopy   "
105495|NCT01905228|"     The primary objective of the study is to determine the maximally tolerated dose and     recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with     metastatic or unresectable advanced solid malignancies.   "
105496|NCT01905215|"     The purpose of this first time in human (FTiH) study is to evaluate the safety,     reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus     (RSV) investigational vaccines in healthy men.   "
105497|NCT01905202|"     Secretrol administered over a 6 month period to patients with Barrett's Esophagus will be     safe and well tolerated. Further, pH control will be evaluated in the distal esophageal     mucosa and just below the squamocolumnar junction.   "
105498|NCT01905189|"     Pulmonary arterial hypertension is a disease characterised by pathological changes in the     pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and     pulmonary artery pressure. Right ventricular failure is the main cause of death in patients     with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the     progressive increase in pulmonary vascular resistance associated with changes to the     pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a     patient's functional capacity and survival.      Right ventricular dyssynchrony was present in a substantial proportion of patients with     pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular     function.   "
105499|NCT01905176|"     The current trial aims to examine the effectiveness of three different types of nursing     interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared     to the usual care. The interventions include promotion of self-care practices through     education and support; they are either provided before discharge, post-discharge through     telephone, or both.   "
105500|NCT01905163|"     This prospective nonrandomized multicenter phase II study, will evaluate the possibility of     performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in     highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.   "
105501|NCT01905150|"     Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is     the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being     6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with     limited efficacy. A safer and more effective therapy for this devastating disease is greatly     needed.      G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and     used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin,     Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic     cancer) is based on laboratory and clinical results, which indicates the synergistic efficacy     of these anti-cancer drugs against cancer cells and overcoming tumor drug resistance that     cancer cells frequently develop. Also, because of their low doses, this regimen is less toxic     than when these drugs are used alone.      Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily     nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer     activities. This is especially true when Vitamin C is used in combination with other     anti-cancer drugs.   "
105502|NCT01905137|"     The purpose of this study is to determine whether there is a change in patient-reported     pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of     normal saline.   "
105503|NCT01905124|"     This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active,     sight-threatening, noninfectious intermediate or posterior uveitis.   "
105504|NCT01905111|"     The primary objective of this trial is to explore the safety and tolerability of BI 853520     monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese     patients with advanced or metastatic solid tumours.      Secondary objective is collection of preliminary data on anti-tumour efficacy   "
132105|NCT01556204|"     The objective of this study is to conduct a prospective randomized controlled trial of     robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.   "
105507|NCT01905072|"     The goal of this study is to compare the effectiveness of structured CHW- provided home     visits, using an intervention created through community-based participatory research, to     standard care received through WIC office visits in preventing the development of overweight     (weight/length >85th percentile) and obesity (weight/length >95th percentile) in infants     during their first 2 years of life.      Hypothesis 1: Children in the intervention group will remain within their growth centiles in     height/weight and weight for age, while children in the control group will increase in     height/weight percentiles and weight percentiles more rapidly (> .67 SD) during the first     year of life.      Hypothesis 2: Fewer children who receive the intervention will have BMI >95th percentile at     ages 2 and 3 than the children in the control group.      Hypothesis 3: Children who receive the intervention will exclusively breastfeed for a longer     period of time than will children in the control group.      Hypothesis 4: Children who receive the intervention will have a higher percentage of fruits     and vegetables and a lower percentage of sweetened beverages, desserts, and candy in their     diets at ages 1, 2, and 3, than will children in the control group.      Hypothesis 5: Parents in the intervention group will be more responsive to infant feeding     cues (hunger, satiety)than parents in the control group.   "
105508|NCT01905059|"     Multicenter, randomized, superiority trial to evaluate efficacy of a mono or bi-therapy of     protease inhibitors with or without lamivudine over a period of 96 weeks. The primary outcome     will be the failure rate at 96 weeks. This study will include 260 participants, former     participants of the 2LADY trial. It will be carried out in Yaoundé, Bobo Dioulasso and Dakar.   "
105509|NCT01905046|"     This randomized phase III trial studies metformin hydrochloride to see how well it works     compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in     situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming.     The use of metformin hydrochloride may prevent breast cancer.   "
105510|NCT01905033|"     Background: Sepsis is a major cause of in-hospital morbidity and mortality. Current tools     available to the clinician to initiate therapy of patients with sepsis mainly comprise of     symptom classification systems and culture techniques, which provide aspecific and slow     information.      Objective: The ultimate goal of this program is to assist the physician at the bedside in     tailoring the treatment of an individual patient suffering from sepsis by generating rapid     molecular information about the causative pathogen and the host response.      Deliverables: Rapid tests (sample-in-result-out) that can be used by health care personnel     at or close to the bedside and that provide rapid information (within two hours) about the     presence or absence of sepsis, the causative pathogen and the risk of the individual patient     for sepsis complications and death.      Design: The program is organized into four Work Packages (WPs) along a clinical, discovery     and technology platform. In WP1 two university hospitals will enroll 7500 patients admitted     to the Intensive Care Unit during the first 3 years of the project; 25% - 40% of these     patients will have or will develop sepsis. In WP2 (Pathogen Detection), blood obtained from     these patients will be used to develop rapid, fully automated DNA-based bedside tests that     identify microorganisms and also provide information about their resistance to antibiotics.     In WP3 (Host Response), RNA from blood cells will be analyzed to find novel biomarkers and to     develop rapid and easy to perform tests that provide information about the risk profile of     the patient. In addition, plasma levels of selected protein biomarkers will be measured for     comparison of their value with that of the identified leukocyte molecular signatures. WP4 is     responsible for the ICT management of the project. The Clinical Platform (covered by WP1 and     WP4) delivers patient data and biological samples to the discovery and technology platforms.     The Discovery Platform (covered by WP2 and WP3) uses patient data and biological samples to     develop tests for detection of the infectious agent causing sepsis and for stratification of     patients according to their risk for sepsis complications, including death. The results     generated within the discovery platform will be delivered to the technology platform. The     Technology Platform (part of WP2 and WP3) has the specific aim to develop rapid assays that     run on a fully automated (micro)fluidics platform that is so easy to operate that it can be     used in decentralized settings such as (close to) the ICU. The developed assays will make use     of the knowledge generated in the discovery platform.   "
105511|NCT01905020|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would     regulate glucose levels through the infusion of two hormone: insulin and glucagon.      The main objective of this project is to compare the efficacy of single-hormone closed-loop     strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose     levels in a out-patient study in adults and adolescents with type 1 diabetes.      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in     regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared     to single-hormone closed-loop strategy, which in turn is more effective than the conventional     pump therapy.   "
105512|NCT01905007|"     The primary objective of this study is to compare the composite outcome of total mortality     and operative complications in patients who do not undergo defibrillation testing to those     who do undergo defibrillation testing at the time of initial ICD implantation.   "
105513|NCT01904994|"     Despite increased HIV (Human Immunodeficiency Virus) infection testing in Africa, many     patients never enroll in subsequent HIV care after testing or remain in care after an initial     enrollment. This study's aim is to improve linkage to HIV care and retention in HIV care     through the use of feasible, evidence-based, and practical interventions. The study takes     place in Swaziland, the country with the highest HIV prevalence (24%) in sub-Saharan Africa.     The study will randomize groups of HIV testing sites and affiliated clinics to either     standard of care or a combined intervention strategy (CIS) which consists of point-of care     CD4 (cluster differentiation 4 (CD4)) testing at time of HIV testing, fast-track HIV     medications for those who are eligible for treatment,mobile phone appointment reminders, care     bags filled with health prevention materials, and financial incentives. The study outcomes     are linkage to and retention in care as well as cost effectiveness, feasibility of     interventions, and patient acceptability of interventions.   "
105574|NCT01904175|"     Allogeneic transplantation is used to treat many malignant and non-malignant diseases. The     investigators and others have shown that less toxic preparative regimens (reduced intensity     or 'mini' transplants) allow reliable allogeneic engraftment and durable remissions,     significantly broadening the population of patients who may be offered this therapy to those     who are older and more infirmed. The field is now focusing on the period post transplant for     approaches to immune recovery leading to improved outcomes.      The primary objective of this registry is to catalogue data from patients who undergo     standard of care reduced intensity allogeneic transplantation.   "
105577|NCT01904136|"     The goal of this clinical research study is to learn about the safety of giving a kind of     immune cells called natural killer (NK) cells with standard chemotherapy and an allogeneic     stem cell transplant (using cells from a donor). Researchers also want to learn the highest     tolerable dose of NK cells that can be given.      Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous     cells. Researchers believe that the NK cells you receive from the donor may react against the     leukemia cells in your body, help eliminate leukemia, and prevent disease relapse.   "
105514|NCT01904981|"     Various medical therapies have been proposed to prevent abdominal aortic aneurysm expansion.     However, there have been very few randomized clinical trials to support use of any of these     treatments. Several animal studies and observational reports suggest that ARBs can be useful     in reducing abdominal aortic aneurysm (AAA) growth. However, so far, ARBs have not been     evaluated in a randomized clinical trial. Therefore, the purpose of the study is to evaluate     the effect of valsartan, an ARB, on annual growth rate in comparison with atenolol, a     beta-blocker. Our hypothesis is that valsartan is superior to atenolol in the suppression of     the aneurysm growth at 12 months. The BASE trial is designed as a investigator-initiated,     multi-center, randomized controlled open-label trial. Patients with small AAA (aorta diameter     <5cm) will be randomized 1:1 either to valsartan or to atenolol group. Randomization will be     stratified by the AAA size (max. diameter >4 cm or ≤4 cm). Patients will receive either     valsartan (daily dose 80 mg or more) or atenolol (daily dose 50 mg or more) for 12 months. A     CT scan will measure the maximal diameter of AAA at baseline and 12 months. The annual growth     of AAA will be compared between the valsartan and the atenolol group.   "
105515|NCT01904968|"     We conducted a preliminary study in 2010 using the innovative Illumina GoldenGate     (methylation assay) which has enabled us to characterize the level of methylation of 807     potential markers on a series of 200 adenocarcinomas of the colon (C18) and rectosigmoid     junction (C19) resected between 1998 and 2001. The results, validated by pyrosequencing,     allowed us to establish a panel of 12 markers to assess the level of methylation. The aim of     this project is to validate the prognostic value of this panel in a second cohort of patients     with adenocarcinomas (stage I to IV) resected between 2002 and 2006 in public and private     hospitals (n=685).      This study relies on an original collection of surgical specimens of colorectal cancers     resected in public and private hospitals among patients resident in the département of     Côte-d'Or and followed by the cancer registry of Burgundy. Samples obtained from each cancer     and from adjacent normal mucosa are stored in liquid nitrogen in the Ferdinand Cabane     Biological Resources Centre(certified S 96900). Annotations are collected by the cancer     registry staff from multiple sources (pathologists, gastroenterologists, oncologists and     radiotherapists).      Pyrosequencing will be used to quantify the level of methylation. The percentage of     methylated allele for each marker on cancerous DNA and the ratio of methylated markers to the     number of markers analyzed will be determined. The molecular status of MSI, BRAF, KRAS, and     PI3K will be taken into consideration.      To study the prognosis, relative and relapse free-survival will be calculated. A multivariate     relative survival analysis will be performed to determine independent prognostic factors     taking into account the characteristics of patients and tumours and epigenetic and molecular     alterations. Epigenetic alterations will be described according to age group, sex and     subsite. The epigenetic phenotypes will be evaluated according to already known molecular     status using logistic regression models.   "
105516|NCT01904955|"     The results of this study will make it possible, thanks to better understanding of the     natural history of colorectal cancer, to define new treatment and surveillance strategies for     colorectal cancers resected with curative intent, so as to improve management and thus     improve patient survival.      These data will also make it possible to calculate the prevalence of patients who require     treatment or surveillance because of their disease.   "
105517|NCT01904942|"     The project is based on a case-control study including cirrhotic patients with (200 cases)     and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in     proteomic or spectroscopic studies has to be adapted to the high dimensional setting. The     proteomic analysis will be conducted by Clinical Innovation Proteomic Platform of Dijon. Two     approaches will be used in the proteomic study: A global approach based on the comparison of     proteomic spectra profiles obtained after mass spectrometry analysis (MALDI-TOF). The     particularity of this study with regard to previous studies is : the procedures used to     purify the sub proteomes (Five automated methods including depletion fractionation and     purification will be applied), the qualification of the generated data with the introduction     of quality controls, the high number of samples included in the study. The second approach     BIA-MS (Biomolecular interaction analysis mass spectrometry) is targeted approach allows the     capture, quantification and characterization of proteins.      The quality controls allow to quantify the various variability sources and to validate that     biological variability is higher than technical variability. All the samples will be treated     and analyzed with the same protocols, 100 samples will be used to validate the marker and     statistical models developed after analysis of the first 500 samples. The infra-red     spectroscopy analysis will be conducted by MéDIAN team, CNRS UMR 6237 of Reims university.     The first 300 samples after feature selection reference spectra, are classified into     different classes by means of mathematical classification methods such as multivariate     statistical processes of pattern recognition, neuronal networks, support vector machines and     methods of case-based classification or machine learning, genetic algorithms or methods of     evolutionary programming. The analysis of a second set of samples (300) will validate the     different mathematical classification methods developed.      In the global study the investigators will unravel the relationship between proteomic,     spectroscopic and metabolic/nutritional data. The description of these relationships will use     canonical analysis and multi-block analysis in a more general extent. The goal of these     methods is to explore relationships that may exist between several groups of quantitative     variables observed on the same set of individuals.   "
105518|NCT01904929|"     The objective of this project is to clarify and improve the efficiency of the standardized     walk-test in Cardiovascular Rehabilitation. The psycho-metric properties of the 400m walk     test at a self-selected speed will be evaluated. Such tests, made at a self-selected     (comfortable, free) speed particularly assess the endurance capacities. The results of     the physiological measurements during the tests will be compared with those of TM6min of Test     of Fast Walking of 200m (TMR200m) and a maximal treadmill exercise. Stable coronary patients,     aged over 55 years old, will be included.      This study should permit a simplification and a better understanding of the clinical-use of     walk tests. In the future, two kinds of tests might be proposed with different distances, 1-     200m-fast-walking-test aimed to evaluate the performance closed to the maximum capacity, 2-     self-selected-walk-test on a doubled distance (400m) aimed to evaluate the aerobic capacities     of the adaptation of the body in response to effort.   "
105519|NCT01904916|"     Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly     testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful     examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5%     frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting     molecularly stratified patient populations for studies benefits the patient as it increases     the odds of obtaining benefit from experimental treatment, especially in early clinical     trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy     are picked up in earlier phases. Therefore, broad screening of molecular lesions in the     tumors of patients that are being considered for participation in trials is crucial. This     pre-selection increases our ability to perform several trials in parallel and thus include     more patients in more meaningful trials. With the still dismal prognosis of patients with     metastatic cancer, increasing the accrual rate to pivotal trials in selected patient     populations is a key factor in improving prognosis.      The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number     of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are     now able to deliver clinically meaningful turn-around-times. This development enables us to     use this technology to enrich clinical trials using targeted therapies for patients with     specific mutations.      We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral     blood sample from all patients included in the trial; the biopsies to obtain information on     the tumor related genetic mutations (mutational profile) and the blood samples to assess each     patient's germline DNA background variation. As patients will be asked to undergo an invasive     procedure it is important to address the potential safety issues. Review of the literature     and our own experience show that tumor biopsies can be performed with only minor     complications and acceptable risks. We will recruit patients with metastatic or locally     advanced solid tumors from patients that can potentially be included in clinical trials.   "
106029|NCT01898208|"     Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus     (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive     blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to     increased cost)?   "
105520|NCT01904903|"     HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells)     than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive     breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the     receptor HER2) were developed, patients with HER2 positive breast cancer had a very     aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly     targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine,     patients are able to live longer and have better control of their cancer.      Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and     for this reason these treatments were only studied and approved for patients with normal     heart function.      In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast     cancer and mildly decreased heart function along with concomitant evaluation by a heart     doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do     frequent monitoring of the heart function with a test called echocardiogram that will give us     a detailed picture of the heart. We will also draw blood along with routine blood tests to     try to understand why some patients develop heart problems and others do not. The study will     take a maximum of 12 months and patients will be monitored for 6 additional months.      We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast     cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on     appropriate heart medications.   "
105521|NCT01904890|"     This is a behavioral research study to evaluate the effectiveness of a type of health     education, lay health worker (LHWs), on increasing the use of a routine health behavior,     colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening.     Using quantitative and qualitative methods and a community-based participatory research     (CBPR) approach, the project will develop and implement a group randomized controlled trial     to evaluate LHW effectiveness in promoting CRC screening among Asian Americans age 50 to 75.     The investigators will conduct focus groups and individual interviews with community     participants to revise training and survey materials developed in prior projects. The     investigators will recruit LHWs to be randomly assigned to the intervention arm and to the     comparison arm. The LHWs will each recruit 15 participants from their social network.     Intervention LHWs will be taught to teach their participants about CRC screening through 2     outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. LHWs     and participants in the comparison group will receive a bilingual CRC brochure as well as 2     lectures on healthy nutrition for cardiovascular health delivered by a health educator and an     optional post- intervention LHW outreach session on CRC screening. Effectiveness of the     intervention will be measured by pre-intervention and post-intervention surveys of community     participants' CRC screening behaviors. The investigators will also conduct ethnographic     observations of LHWs and their participants during the small group sessions and post-     intervention focus groups to understand how such a health education approach may work.   "
105522|NCT01904877|"     1. The number of MSM who are tested for HIV in the 4 study clinics over 12 months will          increase compared with historical data from the same 4 clinics over the past 12 months          prior to the intervention.        2. Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts at          diagnosis than persons diagnosed with HIV over the past 12 months prior to the          intervention   "
105523|NCT01904864|"     This study is a randomized, controlled, double-blinded single center trial to compare the     efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency     anemia in infants and young children.      Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in increasing hemoglobin     concentration during a twelve week course of treatment to subjects with iron deficiency     anemia.      Primary Aim:      To compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional     IDA in infants and young children as determined by increase in hemoglobin concentration.      Secondary Aims:        1. To compare the adverse effects of treatment for IDA between ferrous sulfate and          NovaFerrum®        2. To compare normalization of iron stores as demonstrated by laboratory measures of IDA          (ferritin, TIBC, reticulocyte hemoglobin content) between subjects treated with ferrous          sulfate or NovaFerrum®        3. To compare the adherence to study medication between subjects on ferrous sulfate and          NovaFerrum®        4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional          IDA   "
105524|NCT01904851|"     XLPAD is an observational study designed to evaluate the effectiveness and use of stent and     non-stent based therapies among PAD patients. The study will create a registry that will     include entry of procedural and clinical follow-up information into an online data collection     software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until     14,000 patients have been included. The primary objectives of this observational registry     study are to:        1. Compare stent and non-stent based outcomes defined as a composite of symptom driven          target vessel revascularization (TVR), unplanned surgical revascularization of the          target limb and need for target limb amputation through 12 months post-index procedure          (Primary efficacy endpoint)        2. Compare stent and non-stent based outcomes defined as a composite of causes such as:          death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel          revascularization (TVR) and unplanned surgical revascularization/amputation of the          target limb through 12 months (Primary safety endpoint)        3. Compare stent and non-stent based change in walking distance, Rutherford category and/or          ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical          improvement endpoint)      Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment     in the observational study will be monitored in an effort to achieve at least 20% (and no     more than 80%) of the population receiving stents as the initial treatment strategy.     Follow-up visits by sites will be reported at 6 and 12 months after index procedure to     collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures     are not mandated by the registry protocol. Each site will be encouraged to enter follow-up     information derived from clinically indicated follow-up visits. All events post-index     procedure till the 7th month will be reported under the 6 month follow-up form and subsequent     follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form.      Patient management and treatment decisions are at the discretion of the care team per routine     clinical practice. The procedural aspects (including selection of stent type or non-stent     based treatments) and follow-up are not mandated by the registry and will be up to the     discretion of the operator and/or based upon the practice dictated by the clinical care of     the patient. Therefore the study poses minimal risk to the patient.   "
105531|NCT01904760|"     Reconstruction using microvascular free tissue flap has been an important management in     patients with maxillofacial tumor. It is often characterised as long operation time, more     traumatic and require restriction of patient's head movement postoperatively in order to     prevent disruption of microvascular anastomosis. Agitation and delirium are common in     patients with free flap surgery, which may lead to serious consequences such as self     extubation, injury or even failure of the flap.      Dexmedetomidine is a sedative and co-analgesic drug with high specificity for     α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after     free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on     preventing delirium has not been proved.      The investigators hypothesized that the use of Dexmedetomidine would reduce emergence     agitation and prevent delirium in patients after free flap surgery.   "
105525|NCT01904838|"     The overall objective of this study is to develop and test an efficient set of self-report     instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual     factors important in healing. The initial phase of the study involves developing and refining     an item bank. During the initial 'item bank development' phase, the investigators will run     focus groups and cognitive interviews with individuals who participate in CAM and     conventional medicine interventions. The next step of instrument development is called     Calibration, and involves administering the revised item bank to an internet sample and to     persons who receive services in a CAM clinic and a conventional primary care setting. The     items will be calibrated using item response theory and classical test theory. This will     result in a computerized adaptive testing version of the instrument, as well as a static     short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to     the Calibration Phase of the study. The final phase of the project will involve conducting     initial validation studies of the set of instruments. The set of instruments will be called     the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate the     convergent, discriminant, and predictive validity of the HEAL instruments in a sample of 200     persons with chronic low back pain who are receiving physical therapy, chiropractic care, or     mindfulness-based stress reduction. For convergent validity, the HEAL is expected to display     moderate to large correlations with measures of similar constructs. The HEAL is expected to     correlate modestly with self-report measures of general psychosocial functioning, in support     of discriminant validity. Finally, HEAL scores should account for a significant proportion of     the variance in treatment outcome, supporting predictive validity.   "
105526|NCT01904825|"     The aim is to set up tools that will serve as quality tracers for cryopreservation     procedures.      To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in     the medium term, can be used as controls to guarantee the quality of preservation for     biological samples.      The biological tools and an optimised follow-up strategy will make it possible to validate     preservation procedures at the CRB in order to guarantee the perfect stability of samples and     the validity of clinical studies.   "
105527|NCT01904812|"     Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and     in clinical research requires several aspects to be taken into account, in particular the     impact of disease activity on quality of life. To date, the effect of systemic lupus on     quality of life has only been described using generic questionnaires. Among the specific     questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows     interesting psychometric properties. The determinants of quality of life specifically related     to the disease are still unknown and could be studied using a longitudinal cohort thanks to     the French version of the LupusQol.   "
105528|NCT01904799|"     After a CVA, all of the cognitive functions can be affected and analysed, but the presence of     a language disorder may considerably hamper the evaluation of other functions.      The battery of rapid tests to screen for and quantify cognitive disorders, including the     MMSE, the MOCA, the R-CAMCOG or the RBANS, are not suitable for aphasic patients because they     contain items with a strictly verbal response. Because of this, inexperienced doctors cannot     evaluate higher functions (other than language) of aphasics in routine practice. For the same     reason, aphasics are regularly excluded from post-cva therapeutic protocols, whether or not     the trial bears on the evolution of cognitive functions.      Nonetheless, it is possible to evaluate, at least roughly, all of the cognitive functions     without resorting to language.      The investigator have developed , from validated tests and classical clinical manoeuvers, the     Cognitive Assessment for Stroke Patients (CASP) :        -  for the rapid screening (less than 15 minutes) and quantification of post-cva cognitive          disorders (6 functions: language, apraxia, short-term memory, temporal orientation,          impaired spatial/visio-construction and executive functions);        -  the CASP can be used in most patients, including those with severe disorders of          expression and moderate problems with comprehension, The format of these tests has been          adapted so that severe disorders of expression (essentially left-hemisphere CVA), and          left spatial impairment (right-hemisphere CVA) do not affect the ability to take the          test. Its validity in terms of appearance and content were verified in 2011.   "
105529|NCT01904786|"     During the birth process certain conditions can cause oxygen delivery and/or blood flow to     the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage     occurs in two phases. The first occurs at the time of injury when brain cells in the affected     area 'die'. There is nothing that can be done about this. The second phase of injury occurs     over the next few days. This second phase is caused by inflammation and release of toxic     chemicals from the injured site. Cooling the baby to a temperature of 92.5° F, for 3 days has     been shown to reduce the second phase of injury and bran death. All babies will receive the     benefit of cooling. Although cooling helps it does not completely stop the second phase of     injury.      Melatonin is a naturally occurring hormone that is produced by the brain, and helps regulate     the sleep-wake cycle. It has the potential to stop the second phase of brain injury by     inhibiting inflammation and release of toxic chemicals. The reason for this research is to     find out if melatonin can or cannot improve the outcome of babies with this kind of brain     damage. Every baby enrolled in the study has a 50:50 chance of getting melatonin. A total of     six doses of medicine will be given. The baby's brain function will be assessed by an EEG,     brain oxygen monitoring, and a neurologic examination at 18 months of life. All of these are     routinely used as part of standard care for patients with this kind of problem. The only     difference is that half the babies enrolled in the study will get the drug called melatonin     and the other half will receive placebo. The dose of melatonin being used in the study is     higher than the amount normally produced by the body. No side-effects of this dose have been     reported in other research studies using melatonin in newborn and premature babies.   "
105530|NCT01904773|"     This is a two-part, randomized, multi-center, blinded study in adolescents with Tourette's     Disorder. There will be an up to 21-day screening period in which subject eligibility will be     determined. In Part 1 of the study, the safety, tolerability and pharmacokinetics of AZD5213     will be assessed during a 1- week period.      In Part 2 of the study, the safety, tolerability, and preliminary efficacy of two doses     (depending on tolerability in Part 1 of the study) of AZD5213 and placebo will be assessed     through six consecutive four-week crossover periods. Each subject will receive both AZD5213     and placebo. A follow-up vist will take place at 14 (±) 7 days following the last dose of     study drug.   "
105565|NCT01904292|"     This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and     safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile     Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg)     will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with     body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks.     Tocilizumab was administered every 10 days until pre-planned interim analysis was performed     and changed to Q2W in participants with body weight <30 kg.   "
105532|NCT01904747|"     This study is intended to quantify the effect of food on the extent of absorption of     palbociclib.      The caloric content of the food and the time of the meals with respect to palbociclib     administration may influence the capacity of the body to absorb the drug.      High and low calorie meals will be given to the subjects 30 minutes before palbociclib     administration as 2 of the 3 conditions to compare with completely absence of food in the     body when dosing (fasted).The third condition to test and compare with fasted stage will be     the administration of food before and after palbociclib administration.      This information will help the program to decide wether or not the presence of food when     dosing palbociclib help with its absorption and to what extent it does help. Based on the     collected information, a recommendation about the administration of palbociclib with food     will be provided to patients.   "
105533|NCT01904734|"     This study aims to explore whether men with low testosterone levels, due to altered brain     regulation of male hormone function, who have been previously treated with testosterone,     respond as well as men who have not been so treated to clomiphene citrate, an agent commonly     used for female infertility that has been shown to improve male hormone secretion in some     cases.   "
105534|NCT01904721|"     This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia     (AGA).   "
105535|NCT01904708|"     Phenylketonuria (PKU), an inherited genetic disorder, can cause irreversible brain damage,     declined executive function, and autistic tendencies unless a phenylalanine (Phe) restricted     diet is consistently maintained throughout life. Promoting anabolism, the uptake of free     amino acids from the extracellular space, is a key component to maintaining plasma     phenylalanine concentrations within treatment range among patients with PKU. Exercise     promotes muscle protein synthesis and anabolism, but the effect on blood phenylalanine     concentrations in patients with PKU has not been reported.      Our objective is to assess the impact of an acute bout of moderate intensity exercise on     protein oxidation and plasma amino acid concentrations, as a potential adjunctive therapy for     patients with PKU.      The investigators hypothesize that moderate intensity exercise decreases amino acid     oxidation, increases muscle protein synthesis, and promotes tissue uptake of essential amino     acids, thereby lowering plasma phenylalanine concentrations in patients with Phenylketonuria.   "
105536|NCT01904695|"     The research of clinical effectiveness assessment is to explore the causal relationship     between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment,     the research takes the Resistant Hypertension (RH) as example to study the causal inference     methods under real world.   "
105537|NCT01904682|"     The study will enroll low risk MDS patients who need red blood cell transfusions and who are     refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study is     to determine whether oral rigosertib treatment results in hematological improvements     according to the 2006 International Working Group criteria in these patients. The study will     also record any side effects that may occur during the study.   "
105538|NCT01904669|"     The purpose of this study is to assess the feasibility of conducting an Internet-based     prospective pregnancy study with preconception enrollment with women completing daily     journals for up to 12 months while trying to conceive and weekly through pregnancy if it     occurs.   "
105539|NCT01904656|"     The purpose of this project is to implement and evaluate an intervention to increase and     sustain rates of use of colorectal cancer (CRC) screening among men and women aged 50 and     older in 6 intervention counties in Appalachia Ohio. Researchers will employ community-based     participatory research (CBPR) in combination with two CRC interventions that have been     developed and piloted with community partners to improve CRC screening   "
105540|NCT01904643|"     This phase I trial studies the side effects and the best dose of lenalidomide when given     together with combination chemotherapy in treating patients with relapsed or refractory acute     myeloid leukemia. Lenalidomide may stop the growth of acute myeloid leukemia by blocking     blood flow to the cancer. Drugs used in chemotherapy, such as mitoxantrone hydrochloride,     etoposide, and cytarabine, work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. Giving lenalidomide and combination     chemotherapy may be an effective treatment for acute myeloid leukemia.   "
105541|NCT01904630|"     The project will use exome sequencing to search for genetic predispositions for familial     colorectal cancer (CRC). Except for certain syndromes there is today no good method for     identifying individuals with a hereditary high risk for CRC (about 25% of the cases). There     is currently no routine screening of the population in Norway for CRC today. Coloscopy, which     is the most reliable method, is demanding with respect to resources, it can be painful, and     may have complications. This project will attempt to find genetic determinants for     identification of individuals with increased risk for familial CRC. Such methods will reduce     unnecessary medical examination of unaffected family members, and will make it easier to     focus health services on individuals with increased risk. This will represent a significant     contribution towards improved health reduced death rate caused by CRC. The project includes     research on the ethical aspects, in particular challenges related to how feedback to donors     is handled.   "
105542|NCT01904617|"     This randomized controlled trial aims to compare three groups of intravenous fluids and their     impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline     3) 250 mL/hr of 5% dextrose in normal saline   "
105543|NCT01904604|"     Food allergy occurs when the immune system reacts against foods. The immune system is the     part of the body that protects us from illness and germs, but it can also cause allergies.     Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries.     There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be     severe and life threatening. The only way that you can prevent an allergic reaction is to     avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and     people can be accidently exposed to peanut proteins. Treatment for accidental exposure     include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin)     which must be carried at all times. DBV Technologies has developed an epicutaneous delivery     system, a patch that puts the peanut protein on the skin.   "
105566|NCT01904279|"     This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and     safety of SC administered TCZ in participants with pJIA.   "
105544|NCT01904591|"     This study will enroll 10 adults with a chronic spinal cord injury. The investigators will     image their damaged motor tracts using MRI tractography scanning, and the investigators will     formally assess their ASIA motor level at the outset of the study. Then, the investigators     will treat them with one year of 'over the counter' dosage of selenium and vitamin E. These     are two vitamins known to be anti-oxidants. After one year the investigators will repeat the     MRI scans and ASIA assessments to determine if their has been any change in the appearance of     motor tracts on MRI tractography, or in motor level on ASIA exam. As this is a pilot study     the investigators are primarily concerned with establishing safety of this intervention, with     a view to conducting a larger and more rigorous controlled trial in the future. The     investigators also have a small hope that in fact some improvement might be found with     vitamin treatment.   "
105545|NCT01904578|"     Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to     poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe     technique that can be easily taught to menopausal women so that they apply it as a self-care     method and a manager of sleep disruption. The purpose of the present study was to evaluate     the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind     randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65     years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI     ).Participants were randomly assigned to an acupressure group, a sham acupressure group and a     control group by two time randomized method (systematic and simple randomized). These     interventions were carried out for 4 consecutive weeks. Participants in acupressure group and     sham acupressure group learned to carry out acupressure technique as a self care at home with     the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas     only conversation was used in the control group. The statistical software package for social     science (SPSS) Version 17 was used for data analysis.   "
105546|NCT01904565|"     This is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia     and proton beam radiotherapy in patients with primary or recurrent unresectable soft tissue     sarcomas of the extremities, trunk, retroperitoneum (except intrabdominal). The primary     purpose would be to assess the safety and efficacy of this approach along with local tumour     regressions and subsequent tumour downstaging, thereby enabling a near total removal of these     tumours following the hyperthermia and proton beam therapy.   "
105547|NCT01904552|"     The aim of this in vivo study is to evaluate the influence of apical periodontitis (AP) on     the accuracy of Dentaport ZX, Raypex 5, and i-Root electronic root canal length measurement     devices.   "
105548|NCT01904539|"     This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid     (OCA) in healthy volunteers and patients with liver disease.   "
105549|NCT01904526|"     Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces     pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.   "
105550|NCT01904513|"     The primary objective of this pilot study is to determine if consumption of a probiotic     yogurt causes reduced levels of environmental toxins in a group of school-aged Tanzanian     children. The secondary objective is to determine the levels of environmental toxins in     Tanzanian children and compare these to literature values of levels believed to negatively     affect health and development. The third objective is to analyze the intestinal microbiota of     the children and to determine if consumption of a probiotic yogurt has a significant affect     on the microbiota composition.   "
105551|NCT01904500|"     Obesity has become an increasingly prevalent public health problem in the United States,     reaching epidemic proportions. According to 2009 CDC epidemiologic data on obesity in the     United States, 35.7% of the United States population is considered overweight or obese.     Currently, on the review of the literature, over 20% of pregnancies in this country are     complicated by maternal obesity. Obesity has been well demonstrated to be correlated with     numerous adverse pregnancy outcomes such hypertensive disorders of pregnancy, gestational     diabetes, and increased rates of operative delivery. Moreover, obesity, irrespective of     pregnancy, has been demonstrated to be an independent risk factor for the development of     postoperative surgical site infections. Development of such infections can have both     consequential long-term medical sequelae for patients and economic impacts on the health care     system at large. Cefazolin, a first generation hydrophilic cephalosporin whose clearance is     exclusively mediated via the kidneys unchanged, is used as pre-operative antibiotic     prophylaxis for cesarean deliveries. The current accepted standard of care is to administer 2     grams of cefazolin within 60 minutes of skin incision. Studies of drug concentrations of     cephalosporins for pre-operative antibiotic prophylaxis in obese bariatric patients have     shown that therapeutic concentrations may not be achieved in both tissue and plasma. Limited     data exist in pregnancy. Therefore, it is the goal of this study to investigate whether obese     patients presenting for cesarean delivery require an increased dosing amount of pre-operative     antibiotic prophylaxis. This study will randomized women with a pre-pregnancy body mass index     of 30 kg/m2 or more who are presenting for their scheduled cesarean delivery to receive     either 2 grams or 3 grams of cefazolin for pre-operative antibiotic prophylaxis. By drawing     blood at specific time points in the peri-operative period and extracting adipose tissue     samples during cesarean delivery, this study will investigate the pharmacokinetics of     cefazolin in both the plasma and tissues of the obese gravida.   "
105552|NCT01904487|"     Background:      - This study is being done to examine the role of a chemical GABA in the brain of alcohol     dependent patients. GABA is the chief inhibitory neurotransmitter in the central nervous     system. It helps induce relaxation and sleep and balances the brain by inhibiting     over-excitation. Several studies have reported that anxiety disorders such as panic attacks,     seizure disorders, and numerous other conditions including addiction, are all related to low     GABA activity. Therefore, we will examine differences in GABA levels between healthy controls     and subjects with alcohol addiction. Studies such as this are important to the understanding     of the role of GABA in alcohol addiction.   "
105553|NCT01904474|"     This study aims to:      I. Determine the e-therapeutic intervention program effectiveness compared with the standard     treatment protocol, on both the behavioural change (treatment adherence and promotion of     healthy lifestyles) and health impact (weight control and quality of life), based on a     population of adolescents followed at Paediatric Obesity Clinic (POC) of Hospital de Santa     Maria (HSM), Lisbon (Portugal).      II. Evaluate the health profile, treatment adherence, lifestyle and impact of weight on     quality of life of this population.      III. Test the usability of an e-therapeutic platform for obese adolescents and their     families.   "
105554|NCT01904461|"     The long-term objective of this study is to prove:        -  the equivalence of the number of post-operation hemorrhages, and maybe a decrease of the          number of secondary hemorrhages        -  the decrease of pain and quicker re-feeding        -  an easier haemostasis        -  the simplification of the tonsillectomy surgical kit        -  the decrease of dissection time   "
105555|NCT01904448|"     To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus     24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children     without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed     cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or     cochlear nerve disorders. These conditions can include: developmental or acquired cochlear     nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or     cochlear malformation.      This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24     Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure,     tolerance of device stimulation, and the potential for auditory benefit beyond that     experienced with their CI. This study will provide the preliminary experience for a larger     scale clinical trial.      Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development     of sound awareness and improved speech understanding among children implanted with the ABI     when compared to their baseline skills. Aim 3: Demonstrate the development of oral language     skills following the use of the ABI that were not evident prior to its use.   "
105556|NCT01904422|"     Periodontitis is an infectious disease that destroys the tooth supporting tissues and     triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk     factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting     and maintaining an appropriate glycemic control. It has been reported an average decrease of     0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus     untreated. It is not has been established that periodontal treatment type in spaced sessions     (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24 hours),     has a greater impact on glycemic control in type 2 diabetes patients.      Objective: To evaluate the effectiveness of intensive periodontal treatment modality as     compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.   "
105557|NCT01904409|"     The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo     in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all     causes) or hospitalization, in subjects with early decompensated liver cirrhosis.      Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for     the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver     cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin.      Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for     24 weeks.   "
105558|NCT01904396|"     There are some adults with skeletal muscle weakness (called myopathy) and heart muscle     weakness (called cardiomyopathy) who have low blood levels of a compound called carnitine     as a cause of their problems. Carnitine is very important to energy production in muscles. In     fact, there are reports of some people with carnitine deficiency who have developed myopathy     and cardiomyopathy that was completely reversed with carnitine treatment. The main objective     of our project is to determine the number of patients who have carnitine deficiency as a     cause of their myopathy and cardiomyopathy. The investigators will be measuring carnitine     levels in 1000 patients with cardiomyopathy and will describe the specific features in all     the study patients to see if there are any trends that may help us predict which patients     with muscle weakness are at risk of developing low carnitine levels. The investigators will     be treating patients with low carnitine levels with carnitine and observing them to see if     their cardiomyopathy and their muscle weakness improve. Knowing the exact percentage of     myopathy and cardiomyopathy patients with carnitine deficiency may allow for screening of     patients in a cheap and targeted way to treat the serious complication of this condition,     including heart failure and sudden death.   "
105559|NCT01904383|"     Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as     add-on therapy in patients with type 2 diabetes mellitus.   "
105560|NCT01904357|"     The primary objective of this study is:      • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years     (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV)     delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.      The secondary objectives of this study are:        -  To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of          cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with          modeling data for adolescents aged 13-17 years (inclusive) and historical data from          adults receiving a single 2g dose of cefazolin.        -  To assess the safety of a single dose of cefazolin in children aged 10 to 12 years          (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX®          drug delivery system for surgical prophylaxis.   "
105561|NCT01904344|"     The NXT_SLEEP study, bringing together industry partners, research groups and (home) care     providers, tackles will develop a next generation sleep-monitoring platform that consists of     less obtrusive sensors, and that delivers complete and useful information regarding the     physiological parameters relevant for sleep-related breathing disorders.      These new and innovative sensors need to be validated in a clinical setting where they will     be benchmarked with the classical sleep monitoring systems. In order to compare the novel     sensors with the classical monitoring system, the investigators use existing technologies     that capture simultaneously the acquired signals of different physiological parameters     relevant for sleep-related breathing disorders.   "
105562|NCT01904331|"     The purpose of this study is to assess the prevalence of cardiac dysfunction and     (undiagnosed) heart failure in women registered in general practice with a history of breast     cancer who received chemotherapy and / or radiotherapy as compared to a matched female     control population.   "
105563|NCT01904318|"     A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation     clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152     mesylate after oral administration in healthy male volunteer   "
105564|NCT01904305|"     This study aims to determine whether interpretations of bronchoscopic results enable     physicians to successfully predict the presence of pneumonia in traumatically injured     patients.   "
106041|NCT01898052|"     The purpose of this study is to determine the periarticular multimodal drug injection has     more efficacy for controlling pain after TKA than single anaesthetic drug injection.   "
105567|NCT01904266|"     This research project intends to look at the effect that a certain type of freezing     injection, called a paravertebral block, has on the pain after an operation for breast     cancer, the amount of pain relief that is needed and the side effects from this pain relief.     The hypothesis is that the paravertebral block, in combination with a general anesthetic will     reduce both pain scores and the amount of strong pain killers (opioids) that is needed. This     will reduce the side effects of the pain killers such as nausea and vomiting.      This will be assessed by comparing it a general anesthetic with pain killers given through     the intravenous (IV) as is routine practice. Patients requiring breast cancer surgery, who     agree to be involved in the trial, will be randomly allocated into two groups: both groups     will receive a block, then a standardised and optimised general anesthetic. In one group     however the block is simply a small injection under the skin (a sham block), whereas the     other group will receive a proper paravertebral block prior to this. Both groups will receive     opioids as necessary, depending on both their bodies reaction during the surgery and their     pain scores when they wake up.      The paravertebral block is a very safe procedure with a very low side effect profile, and     many studies have shown a benefit in breast cancer surgery. The investigators would like to     assess this in our own practice. The block is normally inserted under some light sedation,     with freezing into the skin initially. It is normally very well tolerated. The sham block     will also be performed under light sedation and freezing into the skin. The patients will not     be able to tell whether they are having the sham block or the paravertebral block, because     both are very well tolerated. There are no potential complications from the sham block.   "
105568|NCT01904253|"     The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or     topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on     survival, how much time may pass without disease progression, and the safety of TAS-102.   "
105569|NCT01904240|"     The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic     factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed     throughout the entire nervous system including the central, peripheral, and enteric nervous     system. There is evidence that inflammation plays a major role in neurodegeneration in PD. In     both the striatum and substantia nigra of PD patients activated microglia were found and     proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF. An     inflammation-driven animal model has emerged and has been widely accepted as a model of the     disease based on lipopolysaccharide (LPS) induced neurotoxicity. LPS is an endotoxin found on     the outer membrane of gram negative bacteria and humans are exposed to LPS through the     intestinal tract. The intestinal tract and thus the enteric nervous system serve as a conduit     to the central nervous system. It has been posited that the inflammatory process could gain     access to the lower brainstem via the vagal nerve and then ascend through the basal mid- and     forebrain until it reaches the cerebral cortex, producing various pre-motor and motor     symptoms of PD along the way. LPS may be one of the inflammatory triggers involved in this     process. Systemic exposure to bacterial endotoxin can be determined by measuring plasma LPS     binding protein (LBP). A study of 9 patients with early PD (median Hoehn and Yahr stage 2)     and age matched controls found that the PD subjects had a significantly lower mean level of     plasma LBP compared to control subjects. The aim of the research plan is to establish LBP as     a potential biomarker for PD across a spectrum of disease severity.   "
105570|NCT01904227|"     An randomized clinical trial to investigate whether among adult borderline patients (18 - 40     year), intensified inpatient short term (12 weeks) inpatient Dialectical Behavior Therapy     (DBT) is more effective in declining the proportion of patients that show     suicidal/self-harming behavior in the first 3 months of treatment, compared to standard     outpatient DBT, and whether this difference between the groups is sustained at 6 and 12     months.   "
105571|NCT01904214|"     to quantify the effect of different degrees of renal impairment on the pharmacokinetics of     BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop     dosing recommendations for subjects with renal impairment   "
105572|NCT01904201|"     The health of the immune system in HIV infected people is currently determined from a blood     test measuring the number of cluster of differentiation 4 (CD4) T lymphocytes. These cells     play a critical role in an immune response. Studies have shown that low numbers (below the     normal range) of CD4 T lymphocytes indicates a defect in the immune system. Conversely, the     number of CD4 T lymphocytes within the normal range generally indicates a normal immune     system. When a person is infected with HIV the CD4 T lymphocytes are attacked and destroyed     and the numbers decline meaning that the immune system can no longer effectively protect the     body from infection or cancers. However, when the HIV infected person is successfully treated     with Highly Active Antiretroviral Therapy (HAART) the CD4 T lymphocytes numbers increase and     may end up in the normal range but the immune system may still not function properly as a     number of these cells are incapable of functioning properly.      It would be interesting to know how functional the immune system is rather than the number of     cells. For this, the QuantiFERON® Monitor (QFM or CST007) test is an experimental diagnostic     test used in this study to measure the immune function from people infected with HIV. The     objective of this study is to evaluate the usefulness of the QFM test in HIV infected people     compared with uninfected people by measuring the function of the immune system. The QFM test     measures interferon-gamma released in the plasma following incubation of heparinised whole     blood with a combination of stimulants. As immune function is directly influenced by cells     with actively replicating HIV an additional research test called the HIV Reservoir Test will     be included to better understand the level of immune function in each study subject.      How long will it take? One visit for about 1 hour with Dr. Gatpolintan and his Clinical Study     Coordinator to answer questions, then about 10 minutes for a blood draw (nine blocks from Dr.     Gatpolintan' office).      Study outcome measures (Correlation between QFM and CD4 counts and CD4/CD8 ratios) will be     assessed, including data presentation, within an average period of 1 year after study subject     enrollment.   "
105575|NCT01904162|"     Previous clinical studies have indicated that finafloxacin is well-tolerated with few     treatment-related adverse events. As a part of the clinical development of finafloxacin,     other PK studies are required to determine the effect of other variables on the PK profile of     finafloxacin. This study aims to determine the effect of age and gender on the     pharmacokinetic profile of finafloxacin.   "
105576|NCT01904149|"     This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed     combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison     to the single agents (and placebo for the single dose phase only).      Approximately 600 female patients presenting moderate to severe pain after a total/subtotal     abdominal hysterectomy are eligible to be randomised provided that they experience moderate     to severe pain on the day after surgery.   "
105646|NCT01903239|"     The purpose of this study is to determine the narrowest excision margin for head and neck     Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network®     (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an     acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are     evaluated.   "
105578|NCT01904123|"     The goal of this clinical research study is to find the highest tolerable dose of WP1066 that     can be given to participants with recurrent cancerous brain tumors or melanoma that has     spread to the brain. The safety of this drug will also be studied.      WP1066 is designed to target the STAT3 pathway in cancer cells, which makes these cells     divide, increases new blood vessels to the tumor, causes the cancer cells to move throughout     the body and brain, and avoids them being detected by the immune system. Targeting this     pathway may cause the immune system to kill the cancer cells.      This is the first study using WP1066 in humans.   "
105579|NCT01904110|"     The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM     group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal     osteoporotic women(Phase IV)   "
105580|NCT01904097|"     The purpose of this study is to evaluate effectiveness and cerebral neuronal ability to     adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct     current stimulation.   "
105581|NCT01904084|"     The purpose of this study is to evaluate function, pain and radiographic evaluation in     patients treated with volar locked plating versus Hoffman II bridging external fixation in     patients with extraarticular distal radius fractures, AO/OTA type A   "
105582|NCT01904071|"     Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department (ED)     with intravenous opiates. However, this class of medications may cause deleterious side     effects. An alternative analgesic approach involves regional anesthesia. The investigators     attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNBs) could be     safely performed in an ED setting, (2) whether UPNBs would be more effective than standard     treatment in controlling pain from HFx and (3) which of two UPNBs was superior for pain     relief.      A convenience sample of patients with an isolated HFx and a pain score > 5/10 were enrolled     and randomized to one of three arms: (1) Ultrasound guided 3-in-1 femoral nerve block (UFNB),     (2) Ultrasound guided fascia iliaca compartment block (UFIB), or (3) IVMS. Patients indicated     their pain from 0 (no pain) to 10 (extreme pain).   "
105583|NCT01904058|"     The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a     13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect     of daily dosing with UDCA in combination with LUM001 or placebo.   "
105584|NCT01904045|"     Aim of this study is to investigate whether in patients following kidney transplantation (>6     months after transplantation), the intra-patient variability of levels of tacrolimus is     comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily     (Advagraf), with each regimen for 3 months.   "
105585|NCT01904032|"     This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3     supplementation on depressive symptoms, self-management, and blood pressure in approximately     180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting     adult women who are eligible to participate will be randomly assigned to either a weekly dose     of 50,000 international units of vitamin D3 supplementation or a matching weekly active     comparator of 5,000 international units of vitamin D3 for six months. Participants will     complete approximately four in-person study visits and several telephone visits throughout     the six month trial period, where the researchers will assess depressive symptoms, diabetes     self-management, and systolic blood pressure.      Aim 1: To determine the effect of vitamin D supplementation on depressive symptoms (primary     outcome), self-management (secondary outcome), and systolic blood pressure (exploratory     outcome) compared to placebo.      Hypothesis: Women receiving vitamin D supplementation will report fewer depressive symptoms,     increased diabetes self- management mediated by depression improvement, and have a lower     systolic blood pressure compared to those taking placebo at three and six months follow-up.      Aim 2: To explore the mechanistic effect of vitamin D supplementation on inflammatory     biomarkers and their association with depression.      Hypothesis: Women receiving vitamin D supplementation will have a decrease in inflammatory     biomarkers which will be associated with fewer depressive symptoms compared to those taking     placebo at three and six months follow-up   "
105586|NCT01904019|"     Comparison of functional outcome at 3 years after trapezio-metacarpal arthroplasty with     trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition.   "
105587|NCT01904006|"     Previous studies in human and different mammals have proved that the embryo group culture (in     the same culture medium drop) using a reduced volume is associated with a better embryo     development. This is due to the effect of different autocrine and paracrine factors secreted     by the embryos. Besides, previous studies with embryos from human and other mammals have     shown that a high oxygen concentration may have a negative effect on embryo quality due to     the generation of reactive oxygen species, which cause oxidative stress. The embryo culture     at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.      The purpose of this study is to evaluate the combined effect of the embryo group culture and     the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments.     The specific goal is to compare the embryo group culture in a reduced volume of medium at a     low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension     (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®),     whereas the second condition will be applied using a Heracell incubator (Heraeus®).   "
105588|NCT01903993|"     This multicenter, open-label, randomized study will evaluate the efficacy and safety of     Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small     cell lung cancer after platinum failure. Participants will be randomized to receive either     Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per     meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be     continued as long as participants are experiencing clinical benefit as assessed by the     investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration     attributed to disease progression.   "
105610|NCT01903707|"     The aim of this project is to undertake a randomized placebo controlled trial of cognitive     remediation therapy (CRT) that focuses on working memory training in a sample of community     based patients with chronic schizophrenia or other psychoses.      Cognitive deficits are a problem for many people with schizophrenia. This study will use     computerized cognitive remediation training (which the participant can carry out at home)     over a period of a few months.   "
105589|NCT01903980|"     Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with     acute pleuritic chest pain and therefore must be an important differential diagnosis for     patients in emergency department (ED). The knowledge of characteristics symptoms and correct     management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary     embolism, pericarditis or acute coronary disease.      Despite the importance of this entity, only fewer than 40 cases have been reported since     1957, when the condition was first described.      We have seen a couple of similar cases in our institution during a short period of time, and     we suspect that these numbers doesn`t mean the real prevalence of epipericardial fat     necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that     tried to estimate an incidence of this entity.   "
105590|NCT01903967|"     Recent studies estimate that the prevalence of pituitary adenomas is approximately 1/1500     persons. Pituitary tumours are usually considered as benign. However, local invasion is     reported in 35-40% of pituitary adenomas; resistance to medical treatment or recurrence     leading to multimodal therapy is reported in about 15% of cases. These tumours are considered     as aggressive pituitary tumours and present a distinct biological and clinical entity with     continued growth despite multimodal therapy, including surgery and radiotherapy (McCormack et     al., 2011). Whilst these tumours have malignant potential, the term of pituitary carcinoma is     strictly reserved for those rare tumours (0.2%) with demonstrated craniospinal or systemic     metastases (Heaney, 2011).      Pituitary aggressive and malignant tumours are very difficult to control and ultimately prove     to be lethal. It was suggested that early aggressive treatments (chemotherapy, radiotherapy)     may control progression and occurrence of metastases. However, these therapeutic options are     associated with important side effects limiting their use and the prediction of pituitary     tumor behaviour remains a challenge. At the diagnosis, clinical signs are not specific and     the results concerning proliferative factors (Ki-67 and P53), putative oncogenes (PTTG)     conflict from one series to another.      In a case-control retrospective study of a cohort of 410 patients (HYPOPRONOS), we validated     a prognostic pathological classification based on histological and radiological data (J.     Trouillas 2012 in preparation). Tumours were classified into 3 grades: grade 1= non-invasive     tumour, grade 2= invasive tumour and grade 3 = aggressive-invasive tumor with the combination     of radiological signs of invasion and 2 of 3 signs of increased proliferation (Ki-67     index>3%, number of mitoses>2 per 10 fields at 400X, P53 nuclear detection).      It is now widely accepted that cancer is a clonal disease, which arises from a single normal     cell and progresses thanks to the accumulation of DNA alterations (Sanson et al., 2011). To     identify the role of these DNA alterations, we conducted array CGH analysis limited to 13     prolactin pituitary tumours, from frozen fragments, and identified allelic loss of chromosome     11 associated with aggressiveness and malignancy (Wierinckx et al., 2011).      To confirm these encouraging results we propose to conduct a study on a large series of     tumours, fixed and embed, and to be correlated the results to clinical data.   "
105591|NCT01903954|"     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety     of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will     be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200     mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon     alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending     on response. Treatment-experienced patients categorized as relapsers, partial responders and     viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be     randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus     for 48 weeks. Treatment-experienced patients categorized as null-responders to previous     pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus     Pegasys and Copegus for 48 weeks.   "
105592|NCT01903941|"     Aerobic physical activity attenuates systemic inflammatory activity in individuals with     cardiovascular risk.   "
105593|NCT01903928|"     This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in     subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also     assessed.   "
105594|NCT01903915|"     There were a few studies about the relationship of structural or functional abnormalities of     brain and social cognitive dysfunctions in patients with schizophrenia. In addition, default     network, which increases activity during mental explorations referenced to oneself including     remembering, considering hypothetical social interactions, and thinking about one's own     future, may be associated with social cognitive dysfunctions in patients with schizophrenia.     Therefore, we will investigate the dysfunction of default network in patients with     schizophrenia compared with healthy controls and the effect of default network dysfunctions     on the social cognition in patients with schizophrenia.   "
105595|NCT01903902|"     The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting     balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.   "
105596|NCT01903889|"     The study employs a quasi-experimental design in 8 public health centers in southwest Uganda     offering care and treatment (C&T) services. In 4 health centers, a basic intervention is     introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women.     They are charged with counseling C&T clients on FP; offering condoms, pills and injectables;     and referring clients for other FP methods. In the other 4 health centers, the basic     intervention is introduced along with an intervention for constructive male engagement in HIV     and FP services. This includes training of C&T providers on gender-based influences on health     behaviors; provision of couples' HIV testing and FP counseling services; and community-based     education for men to promote gender equitable norms and male participation in health     services.   "
105607|NCT01903746|"     The epidemiology of this study aims and outcome of patients with septic shock in the     intensive care unit (or versatile) of the North-East region in france as well as the     modalities of care.   "
105608|NCT01903733|"     The objective of the study is to provide long term access to bosutinib treatment and assess     long term safety, tolerability and duration of clinical benefit, without any formal     hypothesis testing; therefore, there is no formal primary endpoint.   "
105609|NCT01903720|"     This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant)     in patients with macular edema associated with branch retinal vein occlusion.   "
142958|NCT01413204|"     The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in     patients with type 2 Diabetes for 24 weeks administration.   "
105611|NCT01903694|"     Principal objective: to evaluate the effect of the combination pravastatin - sorafenib versus     sorafenib alone on overall survival in patients with hepatocellular carcinoma developing on     Child-Pugh A cirrhosis who are unsuitable for curative treatment.      Secondary objectives: evaluate the effect of this treatment on progression-free survival, the     time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT HEP)   "
111197|NCT01830465|"     The aim of this study was to evaluate the efficacy and safety of the combination of Velcade     and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.   "
105597|NCT01903876|"     This is a study to determine whether a theoretically-driven web-based 3-hour intervention     designed for male college students called RealConsent is effective in increasing prosocial     intervening behaviors and in preventing sexual violence perpetration. Sexual violence     programs for this population have been implemented for decades in the United States, but a     program that is web-based and incorporates the bystander education model has never been     implemented or tested. In this study, male college students will be recruited online,     enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the     intervention, investigators will ask questions about their intervening and sexually coercive     behaviors and other theoretical and empirical factors related to the study outcomes.     Investigators will survey the young men again at post-intervention, and at 6-months follow-up     to determine whether young men in the RealConsent program intervened more often and engaged     in less sexual violence compared to young men in the comparison condition. The main     hypotheses are: (1) college men in the RealConsent program will report more instances of     prosocial intervening; and (2) college men in the RealConsent program will report less sexual     violence against women.   "
105598|NCT01903863|"     The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP)     administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill     pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions     during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and     anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump     changes. In addition, this may lead to less overall transfusion with all products (red blood     cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be     neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and     pediatric cardiac critical care units. Subjects will be randomized to receive every other day     FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours)     and FFP use will be compared between the two groups There is a small risk that study subjects     may receive more FFP transfusions and therefore have the increased associated risks however     it is also possible that these subjects may benefit from less ECMO circuit changes and/or     fewer transfusions of all blood products.   "
105599|NCT01903850|"     The purpose of this study is to prospectively assess the efficacy and safety of spray     cryotherapy ablation with the truFreeze System in conjunction with mechanical dilation or     debridement for the treatment of clinically significant obstructions of the central airways.     The primary effectiveness endpoint is the proportion of subjects with a minimum of 25%     improvement in luminal patency following SCT treatment and mechanical intervention 30 days     (+/- 5 days) following treatment. Additionally, a primary clinical safety endpoint is the     reporting of all adverse events.   "
105600|NCT01903837|"     This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted     in 2 parts. The study duration for each subject will be approximately 33 weeks and will     include 25 study visits.   "
105601|NCT01903824|"     This is a single center, double-blind, placebo and positive-controlled, randomized, partial     6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401     (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.   "
105602|NCT01903811|"     This randomized phase II trial compares how well two different doses of carfilzomib work when     given with dexamethasone in treating patients with multiple myeloma that has come back after     a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is     not yet known whether a higher or lower dose of carfilzomib works better when given with     dexamethasone.   "
105603|NCT01903798|"     This clinical trial will test two new therapies for the treatment of alcoholic hepatitis.     Patients who respond to the current standard of care therapy for alcoholic     hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly     assigned to either continue on standard therapy, or, to begin treatment with rilonacept in     combination with standard therapy. Patients who are non-responders to the current standard     of care therapy after 1 week of treatment will be randomly assigned to standard of care or to     begin treatment with mycophenolate mofetil in combination with standard therapy. Patients     will be treated for a total of 4 weeks in this clinical trial. Patients will be followed for     up to five months after completing therapy (6 months total).   "
105604|NCT01903785|"     Athletes using asthma medications called β2-agonists win a disproportionately high number of     medals at Olympic Games. Due to a large variety in the genes that affect how individuals     respond to β2-agonists, the investigators will look at variations in the genetic response to     these medications by dividing athletes into high-responders and low-responders. The     investigators will then compare athletic performance after the inhalation of β2-agonists to     placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing     mechanics. Due to differences in their anatomy females may decrease the energy needed for     breathing during high-intensity exercise to a greater extent compared to male athletes after     the inhalation of β2-agonists.   "
105605|NCT01903772|"     The additional effect of inspiratory muscle training as an adjunct to a general exercise     training program in patients with COPD with inspiratory muscle weakness will be studied. The     main hypothesis is that inspiratory muscle training combined with an exercise training     program improves functional exercise capacity more than an exercise training program without     the addition of an inspiratory muscle training program.   "
105606|NCT01903759|"     The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection     early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing     earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital     and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.      If the kinetics profile of one or several markers correlates strongly with the diagnosis of     chorioamnionitis, it could be used in clinical practice, possibly in the context of another     clinical study.      The results of the study presented here are destined to be published in obstetrics journals.   "
105612|NCT01903681|"     There is increasing evidence that chronic sleep disorders in children with autism spectrum     disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with     disturbed melatonin secretion and melatonin administration has been shown to be effective in     these populations. For children who have difficulties swallowing a tablet, Neurim has     developed an age-appropriate Melatonin formulation in the form of mini-tablets which have the     same dissolution profile as the Circadin® tablets product, thus should produce the same     melatonin concentration-time profile with the same effects. This study concerns the     pharmacokinetic study.      The purpose of this study is to :        -  Establish the 24 hour baseline profile of endogenous saliva melatonin concentrations and          urine 6-SMT excretion in children aged 2 up to and including 17 years with          neurodevelopmental disorders with sleep disturbances.        -  Establish the concentration-time profile of saliva melatonin concentrations and 24 hour          6-SMT urine excretion after 2 and 10 mg Circadin® mini-tablets single dose          administration in children aged 2 up to and including 17 years with neurodevelopmental          disorders with sleep disturbances.        -  Evaluate the adverse event profile after a single dose of 2 or 10 mg Circadin®          mini-tablets in children aged 2 up to and including 17 years with neurodevelopmental          disorders with sleep disturbances.   "
105613|NCT01903668|"     Step 1: Identification and characterisation of the TREM1L protein from samples already     available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of     TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods     for TREM1L (ELISA or SUPRA MS) Step 4: Validation of assays for TREM1L and its isoforms in a     larger number of subjects (inclusion of samples from Dijon CHU and Besançon CHU)   "
105614|NCT01903655|"     The mechanisms of oxidative stress and inflammation involved in mood disorders are factors of     chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular     senescence and are reflected by alterations in systemic gene expression detectable in     leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically     significant markers. The identification of new genetic markers will make it possible to     improve evaluations of the severity and somatic consequences of depressive syndromes.   "
105615|NCT01903642|"     The hypotheses of our research are based on the fact that various pathological states,     infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through     different pathways, even though the clinical presentation can be identical. The     identification of biological markers specific to an etiology would therefore allow a faster     diagnosis and improve care for patients. We thus took an interest in the three groups of     diseases most frequently responsible for an inflammatory syndrome, infections, cancers and     auto-immune diseases. To achieve this, various methods will be used.   "
105616|NCT01903629|"     Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot     be used for the large gastric cavity.This blinded prospective study investigates the accuracy     of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric     symptoms and indication for upper GI Endoscopy.   "
105617|NCT01903616|"     This study investigates the longitudinal course of developmental patterns in movement and     participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan.     Additionally, the predictors in the initial stage in determining the final developmental     patterns in movement and participation in life activities MPLA of these children will be     identified.   "
105618|NCT01903603|"     The primary goal of this study is to establish and evaluate an image-based biomarker for the     impaired motor control and sensory information processing present in Cerebral palsy (CP)     patients   "
105619|NCT01903590|"     The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT)     procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.   "
105620|NCT01903577|"     Robotic surgery holds the potential to overcome many of the ergonomic challenges posed by     laparoscopic surgery. In this study, we propose to quantify this potential ergonomic benefit     by measuring electromyography (EMG) and instrument motion analysis of subjects performing     surgical tasks using robotic assistance versus standard laparoscopic instrumentation.      Hypothesis: We hypothesize that surgeons will experience significant, measurable ergonomic     advantages when performing tasks using robotic surgery when compared to conventional     laparoscopic tools.      Study design: Subjects for the study will include three groups of varying degrees of training     - (1) novice laparoscopists/novice roboticists, (2) expert laparoscopists/novice roboticists,     and (3) expert laparoscopsts/expert roboticists. Subjects will perform the following tasks     (chosen based on their reliability and validity in previous studies). Each task will be     performed with standard laparoscopic instrumentation and with the da Vinci Surgical System.        -  Inanimate (dry lab): Fundamentals of Laparoscopic (FLS) peg transfer, pattern cutting,          intracorporeal suturing.        -  Animate (porcine lab): laparoscopic bowel resection and anastomosis, robotic bowel          resection and anastomosis.        -  Human (clinical case): any laparoscopic or robotic procedure (preferably laparoscopic          bowel resection and anastomosis, robotic bowel resection and anastomosis).      Outcome measures:        -  Time to completion of tasks        -  EMG: peak amplitudes, % maximum voluntary contraction and frequency analysis        -  NASA Task Load Index scores        -  Subject-Reported Qualitative Data from surveys        -  Quality analysis of tasks (e.g., pattern cutting accuracy, % knots tied securely) for          dry lab and animate lab tasks only)        -  Instrument motion analysis of tasks (for dry lab and animate lab tasks only)   "
105638|NCT01903343|"     The aim of the study is to assess the accuracy of shear wave elastography in volunteers.     Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained     using an ultrasound machine. It may be easier to think of shear wave elastography as a     special type of ultrasound imaging which gives doctors a colour picture of body structures     based on their stiffness.   "
105639|NCT01903330|"     This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage     colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to     Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with     recurrent/progressive, bevacizumab naïve glioblastoma multiforme and gliosarcoma (World     Health Organization (WHO) grade IV malignant gliomas, GBM).   "
105642|NCT01903291|"     The primary objective of the study is to estimate the annualized relapse rate (ARR) over a     12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated     with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The     secondary objectives of this study in this study population are to assess the impact of DMF     over a 12-month period on patient-reported outcomes (PROs) and health economic-related     outcomes and to evaluate additional clinical outcomes at Month 12.   "
105643|NCT01903278|"     This study is to confirm the potential effects and assess the safety of a new bio-product     Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and     Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated     with Interferon.   "
105621|NCT01903564|"     Fetal research and clinical practice has been hampered by a lack of suitable investigational     techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy     and physiology, but it has significant limitations for assessment of cardiac rhythm. The     proposed study will allow us to investigate fetal magnetocardiography (fMCG) as a new tool     for the study of normal and abnormal fetal heart rate and rhythm, with a goal of     demonstrating probable benefit from use of the device in patients with serious fetal     arrhythmia. We propose a study that will last 1-2 years and will provide data to aid in     assessing the safety and effectiveness of fMCG for diagnosis and management of patients with     abnormal fetal heart rate and rhythm. We hope that the data from the study will support a     Humanitarian Device Exemption (HDE) application for the subject device. The safety and     efficacy study designs are described below. High-risk subjects will undergo echocardiography     as part of their routine clinical management, and our results will be compared to the     echocardiography results, as well as with postnatal ECG, when available. (Since many     arrhythmias resolve prior to birth, either due to resolution of disease or due to treatment,     only a limited number of diseases allow postnatal comparison). For rhythms that persist after     birth, the diagnostic utility of fMCG and echocardiography will be assessed by computing the     sensitivity (Sn) and specificity (Sp) relative to postnatal ECG for the following prenatal     modalities: (i) the fMCG, (ii) the original (referral) echo, (iii) if available, the in-lab     echocardiogram at the time of the fMCG study. Secondary endpoints will assess changes in     diagnosis and in clinical management due to the additional information provided by fMCG,     compared to the information provided by echocardiography alone.   "
105622|NCT01903551|"     The aim of the study is to evaluate whether loco-regional analgesia reduces post operative     pain compared to intravenous analgesia, in patients undergoing cardiac surgery in     minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment     group) or intravenous analgesia (control group), at the end of the cardiac intervention.   "
105623|NCT01903538|"     Insufficient cognitive control over emotional distracters is characteristic for major     depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is     associated with this deficit. In this study the investigators assess the effect of a decrease     of dlPFC activity in healthy subjects by cathodal transcranial direct current stimulation     (tDCS) on cognitive control.      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators     determine the effect of a single-session of cathodal tDCS to the left dlPFC on cognitive     control in healthy subjects. To assess the cognitive control the investigators use a delayed     response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of     varying valence.   "
105624|NCT01903525|"     In recent years, media attention has focused on the long-term sequelae of repeated concussive     episodes in professional athletes. The growing understanding of the damage done by what was     once considered a ding during a game or match, and the neurologic consequences of playing     through or returning to play too soon has led to additional interest in and concern for     pediatric athletes (18 or under) who experience sports-related concussions during game or     practice play.      Because it has only been in recent years that the full scope of damage done by repeated     concussive episodes has come to light, very little research has been done on treatment of     concussion in either adults or children. Brain injuries in children can be especially     problematic, as the brain may continue to develop until the child reaches the age of 24 or     older, so concussion during this time of development may be particularly damaging.      Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and     algae. DHA is known to improve development of the eyes and brain in young children. It is     thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally     and causes very few harmful side effects, it may be a useful compound in the treatment of     pediatric concussion.      This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric     population. The investigators' primary aim is to determine acceptability of randomization for     this compound as well as rate of enrollment given our clinical population. The investigators'     secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects     who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to     play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated,     clinical indicators of concussive recovery.   "
105625|NCT01903512|"     This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal     derangement of the temporomandibular joint (TMJ).   "
105626|NCT01903499|"     The satiety effects of beef will be compared to beans. Beef is hypothesized to be more     satiating than beans.   "
105627|NCT01903486|"     Would systemic steroids be an effective treatment in early variants of achalasia?   "
105628|NCT01903473|"     The immune system has offensive and defensive capacities. In bone marrow transplantation,     offensive cells in the donor grafts may attack host's organs, leading to a complication known     as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to combat     this tricky situation. Nevertheless, some patients do not respond to this therapy. Recently,     it has been shown that immune system cells having defensive capacities can help in preventing     the occurrence of a GVDH.      This study aims to evaluate if these protective cells together with a non-standard     immunosuppressor can improve the clinical condition and suppress the activity of the     offensive cells in the graft.   "
105629|NCT01903460|"     The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and     tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus     placebo on the biochemical markers and pruritus associated with Alagille Syndrome.   "
105640|NCT01903317|"     The purpose of this research study is to find out more about the relationship between vitamin     D and psoriasis.   "
105641|NCT01903304|"     This is a prospective, randomized controlled nutrition intervention trial to determine     immunological impact of high olive oil consumption in elderly. Aging is associated with     impaired immune response which contributes to higher incidence of infections in elderly.     Previously the investigators have shown that the type of fatty acids in the diet influences     the immune response. In particular, reducing consumption of fats high in n-6 fatty acids has     been shown to improve the immune response in aged. Very few studies have evaluated the role     of olive oil, the main oil consumed as part of the Mediterranean diet on the immune response     of elderly. The investigators hypothesize that high olive oil consumption will improve immune     function in elderly. In addition, the investigators will investigate the effect of high olive     oil consumption on gene expression of relevant pathways in circulating mononuclear cells, as     well as on cognitive function.   "
106183|NCT01896180|"     This is a pilot, proof of concept study to evaluate the safety and efficacy of ALZ-1101 dosed     once daily for 28 days compared to latanoprost 0.005% ophthalmic solution in patients with     elevated intraocular pressure not adequately controlled with latanoprost.   "
105630|NCT01903447|"     Internalizing psychopathologies (IPs) involving depression and anxiety are among the most     prevalent, costly and disabling illnesses. Treatments for IPs are available but the extent to     which individual patients respond is quite heterogeneous. Little information exists,     particularly in the biological domain, which helps to explain individual differences in     treatment response. IPs share similar patterns of dysfunction within the Fronto-Limbic Affect     Regulation and Emotional Salience (FLARES) brain circuit, and two commonly used, 'gold     standard' treatments - selective serotonin reuptake inhibitors (SSRIs) and cognitive     behavioral therapies (CBTs) - are equally effective for both anxiety and depressive     disorders, and appear to change brain activity in the same areas within the FLARES circuit.     The overarching goal of the project is delineate what are common versus specific FLARE brain     targets for SSRI and CBT and identify specific aspects of FLARE dysfunction that might better     predict response to both and to a specific modality of treatment. This experiment integrates     emotion and its interaction with cognition across several stages of emotional experience,     encompassing studies that probe sensitivity to acute and potential threat and automatic and     volitional forms of affect regulation in relation to the FLARES brain network.      We will enroll 200 patients presenting to our Mood and Anxiety Disorders Program seeking     treatment for disabling 'anxiety, worry, depressed mood' (IPs, including those characterized     as Not Otherwise Specified) and randomize them to a 12-week course of SSRI or CBT.     Dimensional, transdiagnostic negative valence systems (NVS) constructs, including FLARES     function, will be measured before and after each treatment. Specifically, the project will     examine 2 Specific Aims: 1) Where and how do SSRI and CBT treatments exert their effects on     NVS constructs?; and 2) Which NVS construct can predict the likelihood of success from SSRI     and CBT treatment? Such findings can be used to guide the right patients to the right     treatments with the highest likelihood of success. They also elucidate a     pathophysiologically-driven mechanistic model of where and how treatments work in the brain     and thus hasten the development of new treatments that target the underlying pathophysiology     across internalizing conditions.   "
105631|NCT01903434|"     The purpose of this study is to measure and compare the amounts of the study drug evacetrapib     found in the blood after taking two different formulations. The study has 3 periods.     Participants will take each formulation by mouth at least once. A minimum of 14 days will     pass between study drug doses. The safety and tolerability of the study drug will also be     examined. Information about any side effects that may occur will also be collected. This     study will last approximately 6 weeks.   "
105632|NCT01903421|"     Many elderly patients undergoing surgical procedures already have impaired cognitive     (memory/concentration) status. Patients with pre-existing cognitive impairment, or dementia,     may benefit from modified anesthesia techniques. It is estimated that one in eight people age     65 and older has Alzheimer's disease. More so, nearly half of people that are 85 years or     older have Alzheimer's disease. Currently, both spinal (regional) and inhalational (general)     anesthesia, are used in patients undergoing common urological, orthopedic, and general     surgical procedures. Inhalational anesthesia has been associated with higher risk of memory     impairment in experimental (animal) and human studies. However, currently, there are simply     no large or good enough studies to be sure that inhalational anesthesia is responsible for     causing dementia and Alzheimer's disease.The proposed study investigates if elderly patients     (65 years and older) undergoing spinal anesthesia (patient is awake or slightly sedated) are     less likely to develop dementia and Alzheimer's disease for up to 2 years after surgery, when     compared to inhalational anesthesia (patient is kept asleep with gas anesthetic). The     investigators will also test all patients for the presence of apolipoprotein (ApoE-Îμ4 type     of gene that is present in 15-20% of patients), and beta-amyloid tau protein (present in     cerebrospinal fluid) that are known risk factors for Alzheimer's disease. The particular     strength of this study is that it takes into account whether the frequency and/or severity of     dementia and Alzheimer's disease is different in patients with and without these markers. The     investigators believe that this study will make a major contribution to better understanding     of development of Alzheimer's disease.   "
105633|NCT01903408|"     For patients with prostate cancer and a high risk of lymph node involvement or confirmed     pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option.     However, conventional radiotherapy of the pelvis has limited by gastrointestinal and     urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of     the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is     given during each session to the prostate or the prostate bed and to confirmed lymph node     metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are     required, and continuation during radiotherapy and for a further two years are strongly     recommended.   "
105634|NCT01903395|"     BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk     for colorectal cancer as well. Nevertheless, participation in the German national screening     program stagnates at 2-3 percent per year even in this high-risk population.      AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which     take up a preventive colonoscopy.      METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly     certified cancer centers and office-based gastroenterologists from all over Germany.     Index-patients with colorectal cancer of different stages are asked to hand over the study     material to their relatives, consisting of an invitation to a nurse-led counseling on     preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the     study sites next.   "
105635|NCT01903382|"     Mortality is subject to cyclic variability: circadian, weekly, and seasonal. This has been     shown for different populations, different diseases and in different countries, but not for     surgical patients. Aim of this study is therefore to investigate the association between     circadian, weekly, and seasonal effects time of surgery postoperative mortality of patients     undergoing surgery and general anesthesia.   "
105636|NCT01903369|"     The investigators would like to compare the stiffness inside and outside nerves using a     special type of ultrasound imaging called shear wave elastography. Shear wave elastography is     a special form of ultrasound as the pictures taken are in colour. An ultrasound machine has     different ways of taking pictures of inside the body: one is by measuring the brightness of     different body parts (often referred to as the B-Mode scan), the pictures taken in this way     are the same as those you may have seen of unborn babies inside their mum's tummies; another     way is by measuring the stiffness of different body structures which is how shear wave     elastography works. The investigators hope that this new technology will help doctors to see     the parts of the body that are important to them.   "
105637|NCT01903356|"     The primary objective of this study is to monitor the safety profile of Trajenta Duo in     Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.   "
105817|NCT01900990|"     The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy     patients innovatively. The investigators randomly allocate the subjects into two groups. One     group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive     Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.   "
105647|NCT01903226|"     The aims of this study are to assess the effects of medium versus high intensity 12-week     adjusted training programs on physical capacity in persons with incomplete SCI, early after     discharge from primary rehabilitation, and to investigate if the training program induces a     more active lifestyle in terms of increased daily energy expenditure.   "
105648|NCT01903213|"     To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical     settings.   "
105649|NCT01903200|"     The objective of the study was to evaluate the safety and plasma concentration changes of     quetiapine after multiple oral administration of FK949E (extended-release formulation of     quetiapine) in elderly patients with major depressive disorder (MDD).   "
105650|NCT01903187|"     The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and     effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with     drug-resistant uncontrolled hypertension.   "
105651|NCT01903174|"     This study is intended to support previous positive results of the AeroForm™ Patient     Controlled Tissue Expander System for breast reconstruction   "
105652|NCT01903161|"     The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in     patients undergoing cardiac valve replacement surgery.   "
105653|NCT01903148|"     The purpose of this study is to evaluate the impact of the last recommendations of the     European Anemia Working Group ERBP in the anemia management in the achievement of the     therapeutic goal of Hb 11-12 g/dL.   "
105654|NCT01903135|"     Rationale of the BIO-OHS study (Prevalence of Obesity Hypoventilation Syndrome):      The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly     assessed in the general population. Actually, this prevalence has been assessed in patients     referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in     patients already diagnosed with sleep apnea. The purpose of this study is to determine the     prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical     laboratories for regular follow-up medical analysis.   "
105655|NCT01903122|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Cevimeline 30 mg under fasted conditions   "
105656|NCT01903109|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Cevimeline 30 mg under fed conditions   "
105657|NCT01903096|"     The strong demand for primary care (PC) services in Spain exceeds resources. Part of this     demand is due to the increasing number of anxiety, depression, and somatization disorders     that affect the general population. These disorders, commonly known as emotional disorders,     are very common in Spanish PC settings, they are poorly detected by physicians, rarely     receive adequate treatment (if they receive treatment it is mostly drugs instead of     psychological treatment), they generate a highly frequent use of PC services, a greater     burden than physical diseases and tend to become chronic without treatment.      Other countries have successfully put psychological techniques in PC into practice (in the     United Kingdom the program known as Improving Access to Psychological Therapies has     obtained very positive results) in order to correctly diagnose and treat emotional disorders.     The results obtained in terms of symptoms, quality of life, diagnosis, etc., have been better     than the usual treatment offered in PC services, involving no side effects, fewer relapses,     and lower costs in the long term.      The general aim of this study is to test how well a psychological treatment program for     anxiety, depression, and somatization disorders works in PC and to compare the results     obtained after seven 90-minute group sessions (every to two to four weeks approximately, for     a period of 24 weeks) with the usual treatment offered in Spanish PC services. Similar     results to the ones already obtained in other countries are expected to be found.      Approximately 1130 adults, regardless of their age and sex, with an anxiety, depression     and/or somatization disorder (diagnosed with a simple and short questionnaire) will     participate in this study.      Participation will be voluntary and confidentiality will be guaranteed. Half of the     participants in the study will be randomly assigned to receive their usual care and the other     half will receive psychological treatment, within the same health care centre. Since it is a     double-blind study, neither the health professional nor the patient will know which     treatment will be applied. Psychological assessments will be carried out before and after     receiving treatment and participants will be followed up at 3, 6 and 12 months.      Participation will pose no risks different from the typically present when receiving usual     treatment. The aim of this study will be to maximize benefits and reduce potential harms     (principle of proportionality).   "
105658|NCT01903083|"     The goal of this study is to evaluate the safety of combination treatment that includes     chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.   "
105659|NCT01903070|"     This is a bi-centric, prospective, open study comparing the effects of linagliptin on active     GLP-1 concentrations in subjects with renal impairment compared to subjects with normal renal     function.   "
105778|NCT01901497|"     The purpose of the study is to compare the pharmacokinetics of nebulized amikacin     administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel     ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are     that the pharmacokinetics varies among the devices tested and that a most efficient device     can be identified.   "
133632|NCT01535820|"     The purpose of this study is to assess the bioequivalence of the contraceptive hormones of     ORTHO EVRA when the patch is applied with and without an adhesive overlay.   "
105660|NCT01903057|"     Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs),     infectious diseases that affect millions of poor people in countries in the developing world.     Trachoma is an eye infection that can lead to painful scarring of the eyelids and blindness     later in life. LF can lead to swelling of usually the limbs (elephantiasis).      Trachoma and LF are preventable and treatable diseases. One important treatment strategy is     annual Mass Drug Administration (MDA): Communities receive drug treatment once a year.     Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF.      Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for     trachoma and LF, where three drugs would be given at one time, would reduce costs and     decrease the burden on the health system.      Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be     recommended, we would have to demonstrate that the safety profile of this treatment with     three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA     (one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the     same day) showed that the safety profiles were comparable; but the results of the study were     not statistically significant and we could not use them to make an official recommendation.      The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL     study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable,     an official recommendation for combined MDA with azithromycin, ivermectin and albendazole can     be drafted.      We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and     exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5     years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding.      Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller clusters     for sufficient power (average household size is 5 people), b) placebo to double-blind     participants and study staff for azithromycin, c) the study area will have undergone fewer     previous rounds of MDA for LF and none for trachoma, and d) smartphones for data entry.   "
105661|NCT01903044|"     The purpose of this study is to determine whether autologous bone marrow-derived stem cells     are effective in the treatment of lower extremity ischemia.   "
105705|NCT01902459|"     The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant     Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal     (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac     thoracic (chest area) surgery.   "
105662|NCT01903031|"     This study will look at a method of hormonal birth control, called the NuvaRing, and specific     anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal     birth control method (specifically oral pills, patches, and injections) and take ARVs have     shown that ARVs interact with the hormones released by the birth control medication. These     interactions may cause the birth control to be less effective at preventing pregnancy. There     is also concern that hormonal birth control can increase HIV spreading to others, but more     studies are needed to determine if this is true. The investigators do not know whether the     NuvaRing and ARVs interact when they are used together, so this study will look to see if     certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by     NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV     infection who are taking ARVs. The study will also include HIV-infected women who are not on     ARVs but will use the NuvaRing to show us what the hormone levels are like in a similar group     of women not on ARVs.      Vaginal rings are also currently being studied to deliver anti-HIV medications that may     prevent HIV acquisition, and to provide birth control over a longer period of time (more than     1 month). Since vaginal rings will become more commonly used to administer medications, the     investigators want to better understand the potential for drug interactions with drugs given     vaginally. This study will also help us understand the potential for drug interactions     between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing.     Additionally, this study will help us understand how hormones released from a vaginal ring     affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of     the female genital track, and the immune system within the genital tract, all of which may     affect the chances of spreading HIV.   "
105663|NCT01903018|"     A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced     Squamous Cell Carcinoma of the Head and Neck   "
105664|NCT01903005|"     The purpose of this study was to assess safety, efficacy, and treatment retention following     extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX)     sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary     efficacy and safety studies of OX219.   "
105665|NCT01902992|"     This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy     with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or     without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization     against birch pollen. The term intraseasonal means that patients will start with     immunotherapy treatment during the birch pollen season, i.e. when the already experience     allergic symptoms.   "
105666|NCT01902979|"     Obesity is one of the most important determinants of quality of life and function. People     with lumbar spinal stenosis may be at increased risk of obesity given walking limitations.     Spinal stenosis is a very common degenerative condition in people over 45. People with this     condition have pain and numbness in the legs during walking, and therefore avoid physical     activity. Lack of physical activity is related to weight gain and increased risk of chronic     disease. Objective: The objective of this project is test a new e-health (online) pedometer     and nutrition intervention aimed at promoting weight loss and increasing physical activity in     overweight and obese individuals with spinal stenosis. Methods: The investigators will     recruit 88 people with lumbar spinal stenosis who are overweight or obese. Half of these     people will receive the 12-week intervention, and the other half will receive usual care (no     intervention). In Weeks 1 and 6, people in the intervention group will meet with a Registered     Dietitian and an Exercise Physiologist for personalized sessions. They will receive a     pedometer and instructions on how to log in to the e-health site     (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website     each week for a nutrition education session, a weekly step goal, and tips. The investigators     will look to see whether people in the intervention group show greater change in physical     activity, body composition and quality of life compared to the individuals who received usual     care. Relevance: The increasing number of people with spinal stenosis represents a huge     health care burden in Canada. This intervention could provide a new treatment option that     would increase mobility, quality of life, and potentially alleviate the need for expensive     treatments like surgery. E-health interventions provide an opportunity for patients to take     an active role in their own health, and promote behaviour changes that will result in     healthier Canadians less likely to access care in the future.   "
105667|NCT01902966|"     The goal of this clinical research study is to learn how many patients with advanced,     recurrent, incurable cervical cancer will complete questionnaires about symptoms, any     anxiety, depression, and/or pain, and the quality of their lives. Researchers also want to     learn how many of these patients will complete a study treatment of propranolol hydrochloride     and relaxation and guided imagery sessions.      Researchers also want to learn if and how propranolol hydrochloride and relaxation and guided     imagery may affect cancer symptoms and any anxiety, depression, and/or pain, and quality of     life.      Propranolol hydrochloride is designed to block certain chemicals that affect the heart.      Relaxation and guided imagery sessions are a form of relaxing meditation that involves     tensing and relaxing various parts of your body from your feet to your head. In the guided     imagery portion, you listen to recordings that are designed to help with calmness, control,     and decreasing stress.   "
105701|NCT01902511|"     This will be a randomized double blind study which will be conducted on patients admitted to     Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having     any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.      60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30     patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will     receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1     year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd     day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice     a week for 2 months.      Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3     months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).   "
106860|NCT01887340|"     The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic     strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I     (cohort 1) or metastatic (cohort 2) seminoma   "
105668|NCT01902953|"     45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of     colon cancer will be included in this study. During colon operation the affected portion of     the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by     a pathologist. Analysis of the lymph nodes in the specimen are important because this is an     important aspect of determining the stage of the cancer.      Once the standard technique is used for the colon removal operation and the specimen is     removed it will be injected with two drugs to help identify the lymph nodes. One is a blue     dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for     the standard pathologic evaluation. The patient themselves will never be injected with these     drugs being used for research.      Following the standard lymph node evaluation, an additional pathologist at an outside     research facility will further examine the lymph nodes in the specimen using more in depth     techniques which are above and beyond the standard of care.      The results of all the pathologic tests will be conveyed to the surgeon of record to help in     their decision making regarding further treatment.      The study hypothesis is that radiotracer will be at least as effective as blue dye in     identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once     identified, these sentinel nodes can then undergo a more in depth review leading to improved     staging of colorectal cancer and more accurate treatment.   "
105669|NCT01902940|"     So far, only limited data is available regarding the natural course in Congenital Cataract     Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body     myopathies (IBM). Several criteria and outcome measures have led to contradicting results.     The investigators want to retrospectively assess the natural course of the disease in CCFDN     and IBM patients according to the data recorded during clinical routine visits.   "
105670|NCT01902927|"     Chronic obstructive pulmonary disease (COPD) is a major health problem whose prevalence is     increasing rapidly. The gradual decrease in exercise tolerance is one of the usual     consequences of COPD that affects the functional independence and quality of life of     patients.      In COPD patients, breathlessness and muscle fatigue are the main symptoms limiting exercise.     Recent studies have shown that most of the physiological mechanisms of psychological factors     such as emotions, motivation, memory, personality, expectations, or prior experience can     greatly influence and modulate the perception of breathlessness. It has been proposed that     the attentional distraction (visual or auditory) during exercise may be associated with a     decrease in anxiety and shortness of breath and could improve exercise tolerance in COPD. We     therefore propose to study the impact of attentional strategies of distraction on the     perception of dyspnea and walking tolerance in patients with COPD.      The research hypotheses are:      i) Compared with exposure to a strategy of negative attentional distraction during exercise,     exposure to a strategy of positive attentional distraction will improve walking exercise     tolerance in patients with COPD;      ii) For a given level of effort, sensory perception and emotional perception will be enhanced     by exposure to a strategy of positive attentional distraction.      Ten subjects with moderate to severe COPD will be recruited at the Research Center of the     Institut Universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ). During an     assessment visit, we will measure complete pulmonary function, body composition and maximal     functional capacity during a maximal incremental test work performed on a treadmill.      During two subsequent experimental visits, and after spirometry control, participants will     perform a walking test performed on a treadmill at an intensity corresponding to 75% of     maximum effort during maximal incremental test. The test will be carried out in combination     with a strategy of either positive attentional distraction, neutral attentional distraction     or negative attentional distraction . The order of the condition will be randomized.   "
105671|NCT01902914|"     To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by     the National Electronics and Computer Technology Center, Thailand.   "
105672|NCT01902901|"     This study is conducting a randomized controlled trial (RCT) with up to 400 subjects (women &     partners) seeking pre-conception carrier testing to assess the impact of the program using     Whole Genome Sequencing (WGS).        1. The investigators hypothesize that whole genome sequencing will increase the detection          of carrier status for Mendelian recessive and x-linked conditions.        2. The investigators hypothesize that parents will act on the knowledge of their carrier          status by making different reproductive choices than parents who do not receive this          information.        3. The investigators hypothesize that the psychosocial risks are increased among parents          who receive expanded carrier screening using Next Generation Sequencing (NGS) compared          with usual care.   "
105673|NCT01902888|"     This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN®     Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).   "
105674|NCT01902875|"     This clinical Trial is proposed to explore whether preconditioning chemotherapy of     Paclitaxel+cisplatin(TP)regimen combined with autologous adoptive CIK cell immunotherapy     could benefit NSCLC patients with a better clinical outcome.   "
105675|NCT01902862|"     The purpose of this study is to evaluate the efficacy (effectiveness) and tolerability (how     well a participant can stand a particular medicine or treatment; ability to be used) of     bortezomib in combination with rituximab standard therapy (medicine or medical care given to     a participant for a disease or condition) in participants with relapsed or refractory (not     responding to treatment) follicular lymphoma (a cancer of the lymph nodes [or tissues] in     follicle).   "
105676|NCT01902849|"     Knowing the fact that the anesthetic substances can alter the immune response during the     surgery, the purpose of the study is to evaluate the influence of two general anesthetic     techniques - inhalation vs. total intravenous anesthesia on the immune response in patient     with colorectal surgery for neoplastic disease, evaluated by the plasma level of the     interleukins 6 and 10(IL6, IL10).   "
105677|NCT01902836|"     Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte     Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients     treated only with conventional treatment.   "
105678|NCT01902823|"     There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued     by cancer patients, but no studies have evaluated the effects of CNNs on important     patient-reported outcomes or indicators of quality of care. This study has two aims:        1. To assess the feasibility of studying the impact of Aurora CNN Program.        2. To pilot test the effects of CNN services on patient-reported outcomes and indicators of          quality of care.   "
105679|NCT01902810|"     This efficacy and safety trial will examine the effects and safety of propranolol     administered to adult patients with severe burn injury. The investigators hypothesize that     propranolol will provide significant benefit to adults following severe burn injury at doses     that are safe and do not increase risk of adverse infectious and non-infectious outcomes.   "
105779|NCT01901484|"     This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged     1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the     effects of the disease will be assessed.Children found positive with S. mansoni will be     treated with praziquantel and followed up for a year.   "
105687|NCT01902693|"     Human Immunodeficiency Virus (HIV) infection is very successfully treated with a type of     therapy called Highly Active AntiRetroviral Therapy (HAART). Although HAART has made a great     improvement to the health and lives of all people living with HIV, HAART cannot be stopped     because it is not able to 'cure' or eliminate the HIV virus from all cells in the body - the     remaining viruses are referred to as 'latent' or sleeping virus. As soon as the HAART     treatment is stopped the virus comes back (wakes up). It is for this reason that stopping     HAART treatment is not recommended. However, it may be that other drugs if given with HAART     could have a stronger effect on the latent virus. There is some evidence from laboratory     research that suggests that some of the drugs we use to treat certain types of cancer may     have an effect on the latent virus. The purpose of this research study is to use new     laboratory research technology to measure the amount of 'latent' virus in people who are     treated with HAART who then need to use chemotherapy treatments for cancer. We will look at     whether the levels of HIV virus are reduced in patients having chemotherapy by looking at the     virus levels before, during and after chemotherapy treatment. We do not know very much about     how HIV persists in the body despite therapy and unless new approaches are developed, removal     of the HIV virus from all cells in the body will not be possible.   "
105680|NCT01902797|"     According to the World Malaria Report, there were significant decreases in the number of     P.falciparum (PF) malaria cases worldwide in the past decade. On the Thai-Myanmar border     where transmission is low and seasonal and where incidence of Multi-drugs resistant     P.falciparum parasites is the highest, the same trend has been observed with a clear decline     in malaria episodes and the ratio of P. falciparum/P. vivax (PF/PV.      Economic development, unprecedented financial support, renewed efforts in vector control, a     wider use of rapid diagnosic tests (RDTs) for malaria and the deployment of artemisinin based     combination treatments (ACT) are the main contributing factors to those successes against     malaria.      However the emergence in Cambodia and on the Thai-Myanmar border of P.falciparum isolates     that exhibit resistance to artesunate is threatening those gains . This is characterized by a     slow parasite clearance rate observed in patients treated with artesunate.      At the same time, recent SMRU surveys along the Thai-Burmese border using a new cutting-edge     technology i.e. highly sensitive quantitative Real Time PCR (RT-PCR) able to detect very low     parasitaemia (10 parasites per ml), found up to a 3-5 fold increase in the prevalence of     malaria compared to what is found with the usual diagnostic tools such as microscopy, RDT or     even conventional PCR.      It seems that a large number of asymptomatic carriers with very low parasites counts (a large     potential malaria reservoir) go undetected. If confirmed, this might pose the greatest     obstacle for malaria elimination in the region and containment of artemisinin resistance.      The purpose of the survey is to further study and understand the epidemiology of malaria in     the refugee camp population using cutting-edge technology (RT-PCR) .   "
105681|NCT01902784|"     Research Protocol Abstract:      This is a phase II controlled trial (RCT) of a storytelling intervention compared to no     treatment among surrogates who have participated in a decision to limit life-sustaining     treatment in the ICU for an incapacitated loved one. Subjects will be sequentially assigned     to storytelling (a facilitated elicitation of the experience 2-4 weeks after bereavement)     or no treatment with follow up monitoring of well-being. Subjects will receive print     bereavement brochures at 1 week, and undergo telephone symptom assessment at 2-weeks,     3-months, and 6-months after bereavement.   "
105682|NCT01902771|"     DC vaccine manufactured and partially matured using our standard operating procedures,     developed in collaboration with the HGG Immuno Group, then administered through imiquimod     treated skin will be safe and feasible in children with refractory brain tumors. This will     result in anti-tumor immunity that will prolong survival of subjects treated and results will     be consistent with the outcomes found for subjects treated by HGG Immuno Group investigators.     Study treatment will correlate with laboratory evidence of immune activation. Correlative     studies will also reveal targets in the immune system which can be exploited to improve     response for patients on successor trials.   "
105683|NCT01902758|"     This study is being conducted to determine the effectiveness of using two FDA approved     medications in concert to reduce the likelihood of sickness due to low oxygen levels and to     reduce the decrement in physical performance at higher elevations. The investigators     hypothesize that this drug combination will reduce the symptoms of acute mountain sickness     and improve exercise performance at high altitude compared to placebo.   "
105684|NCT01902745|"     There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue     (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms     experienced by breast cancer (BC) survivors. PCRF is associated with decreased quality of     life, decreased sleep quality, depression, chronic pain and impaired cognition. Currently,     there are few treatment options for PCRF and existing treatment options are associated with     significant costs, are a considerable burden on the part of the patient, or have unacceptable     side-effects. As such, there is a clear need to conduct studies evaluating the impact of     safe, easy to implement and inexpensive treatments for PCRF in BC survivors.      Individualized nutritional counseling has been found to be beneficial for decreasing fatigue     and improving quality of life in cancer patients receiving treatment.However, there is a     dearth of research examining the use of diet for treating fatigue in cancer survivors. Our     preliminary data in 40 adult cancer survivors found that fatigue severity was associated with     decreased intake of key food groups, e.g., green leafy vegetables, and nutrients, e.g.,     omega-3 fatty acids, as reported in diet records. However, diet records are often not highly     correlated with actual nutrient concentrations in the body and tend to capture short-term     dietary habits not long-term patterns. The main objective of this research is to expand upon     and confirm our cross-sectional preliminary data and to take advantage of a pilot clinical     dietary study we are conducting by examining key nutrient differences in biological samples     in the breast cancer survivors. By examining differences in biological samples we will be     able to explore three key questions, which will directly influence our future interventional     studies: (1) to determine if there are actual differences in concentrations of key nutrients     in body tissue and which nutrients these are; (2) to assess if a dietary intervention focused     on improving fatigue in BC survivors changes baseline levels of key nutrients; and (3) what     is the effect size and variability of change in key nutrients in body tissue both at baseline     and after a dietary intervention.   "
105685|NCT01902732|"     This clinical trial evaluates the impact of catheter-based measurement of interloabr     collateral ventilation prior to endoscopic lung volume reduction in patients with     hetereogeneous emphysema and complete interlobar fissures in high resolution computed     tomography.   "
105686|NCT01902719|"     African Americans represent a particularly vulnerable subgroup of persons with hypertension,     as they are more likely than Whites to have hypertension, equally as likely to be aware of it     and to be treated for it, but less likely to achieve blood pressure control while receiving     treatment. African Americans are also more likely than Whites to suffer end organ damage as a     result of hypertension. Patients' hypertension self-management behaviors (including adherence     to prescribed care, self-blood pressure monitoring, lifestyle changes, and shared medical     decision-making) represent a cornerstone of hypertension therapy. Evidence suggests some     African Americans with hypertension may experience difficulties carrying out positive     self-management behaviors, in part due to cultural beliefs and practices, knowledge and     perceptions regarding the nature and consequences hypertension, and lack of systems to     support ongoing engagement in prescribed care within their communities. Substantial evidence     has demonstrated the important role of family and community support in improving patients'     management of a variety of chronic illnesses.      The goal of this study is to rigorously test the effectiveness of hypertension     self-management interventions that engage African American patients, their families, and     their community-level resources to improve African American patients' blood pressure.      We hypothesize patients' hypertension control rates may be improved when combining community     health worker self-management support with other types of hypertension self-management skills     training.   "
105801|NCT01901198|"     This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of     Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese     healthy volunteers.   "
105802|NCT01901185|"     The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA)     or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept     (Enbrel®).   "
105688|NCT01902680|"     This is a pilot prospective biomedical study of interventional type which includes 17     patients on 24 months (12 months of inclusion and 12 months of follow-up).      The objective of this study is to verify that the focal therapy technique used (with the help     of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie     dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days     after implantation.   "
105689|NCT01902667|"     This is a prospective observational study in which patients with untreated retroperitoneal     sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients     who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two     weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated     with tumour pathology.      The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate     assessment of tumour volume and local staging than CT and will identify areas of altered     oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour     shrinkage occurs.   "
105690|NCT01902654|"     We analyze retrospectively the relationship between traditional cardiovascular risk factors     as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we     compare the results with a control groups of patients with soft tissue disease with no other     rheumatologic condition.   "
105691|NCT01902641|"     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as     rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium,     reversed by low-dose sugammadex. The investigators compare the intubating conditions,     incidence of postoperative myalgia (POM), as well as patient satisfaction for these two     muscle relaxants.   "
105692|NCT01902628|"     This prospective observational study will evaluate the efficacy and safety of Mircera     (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients not on dialysis     with renal anemia. Patients initiated on treatment with Mircera according to the Summary of     Product Characteristics and standard clinical practice will be followed for 10 months.   "
105693|NCT01902615|"     This multicenter, retrospective, observational study will evaluate the therapeutic     effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized     regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical     practice.   "
105694|NCT01902602|"     The objective of this clinical study is to evaluate the influence of the Great     autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular     system in patients with resistant hypertension. The primary endpoint is the change in mean     blood pressure after 10 treatments .      In addition, data are collected on the immune system as well as for food and sleep quality.   "
105695|NCT01902589|"     Helicobacter Pylori (HP) is one of the most common pathogens in humans. This infection can     present in children with abdominal pain, vomiting and iron deficiency. The treatment is     usually empiric and includes antibiotic treatment usually Amoxycillin and Clarithromycin or     Metronidazole. Between 40 to 70 % of the pathogens are resistant to those drugs, and it is     important to characterize the specific sensitivity of the pathogens in any specific area and     in pediatric population. The aims of this study is to assess the sensitivity of HP in     pediatric population in Northern Israel.   "
105696|NCT01902576|"     The purpose of this study is to develop and validate endpoint measures that can accurately     determine whether patients are responding to treatment for chronic Graft-versus-Host Disease     (GVHD). Hopefully, this will also lead to being better able to predict which patients will     respond to what therapies.   "
105697|NCT01902563|"     Background Several studies have shown the effect of osteopathic manipulative treatment on     neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications     and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results     obtained, there is still lack of standardized osteopathic evaluation and treatment procedures     for newborns recovered in neonatal intensive care unit (NICU).      The aim of this research is to provide a guideline on osteopathic approach in treating     hospitalized newborns. Specific evaluation tests and treatments have been developed to tailor     osteopathic method according to preterm and term infants' needs, NICU environment, medical     and paramedical assistance.   "
105698|NCT01902550|"     The purpose of this study is to evaluate effect of co-administration of JNJ-54452840 and     metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the     exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in     healthy participants.   "
105699|NCT01902537|"     The purpose of this observational study is to investigate health related quality of life     (QoL) in Korean female participants with chronic constipation (long term decreased number of     or difficulty making bowel movements) having received treatment previously.   "
105700|NCT01902524|"     The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal     patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic     non-cancer pain.   "
134122|NCT01529307|"     This study will assess safety, tolerability, maximum tolerated dose or recommended dose for     expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.   "
105702|NCT01902498|"     Cardiac bypass surgery is an important treatment for patients with severely blocked arteries     (tubes that delivery oxygen and nutrients to the heart). Hundreds of thousands of these     operations are done each year to help relieve patients' chest pain and to prevent future     heart attacks. The surgery is done by bypassing blood flow around badly clogged arteries by     sewing on healthy vessels from another part of the body (usually from the leg or the chest).     Aspirin (a blood thinner) is given to patients once a day after their surgery because it     stops sticky cells in the blood (platelets) from blocking these new vessels (which may lead     to a future heart attack).      Research has shown that aspirin does not work as well in people after they have bypass     surgery as the investigators might expect (for reasons that are not fully understood). One     reason aspirin may not work as well after surgery is because the body makes many more     platelets after surgery than it would under normal circumstances. All of these new platelets     overwhelm the aspirin and continue to be sticky and ready to block off arteries. The     investigators believe that giving multiple daily doses of aspirin following bypass surgery is     more effective at blocking platelet activity than giving aspirin once daily.   "
105706|NCT01902446|"     Traumatic injury in rural America is a significant cause of morbidity and mortality, and the     challenges of a rural trauma system can put patients at unique risk. Prolonged transport     times to a trauma center, stopping for care at referring hospitals, and longer exposure to     care-associated factors distinguish rural patients from their urban counterparts.     Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing     hospital stay, healthcare costs, and even mortality in the critically injured. The     investigators propose a pilot study to test the hypothesis that a single dose of oral     chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will     decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy     in intensive care units to prevent airway colonization and subsequent development of VAP.     Demonstrating safety and effectiveness of prehospital infection control practices could     significantly improve outcomes of traumatic injury in rural America.   "
105707|NCT01902433|"     The purpose of this study is to compare the changes in pain and self-perceived function     between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of     soft tissue mobilization using instruments) and a specific exercise protocol that involves     strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather     stands for A Stimulation of the body's healing response, describing the physiologic process     which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment     where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild     to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is     to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator     and co-investigator have been trained and certified in administering the Astym treatment. The     specific exercise protocol will involve exercises that strengthen the Achilles and calf     through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes     from applying a controlled lengthening stress to the muscle and tendon.   "
105708|NCT01902420|"     Acromegaly is a rare disease caused by growth hormone (GH) secreting pituitary adenoma in     more than 95% of cases. Acromegaly can be seen sporadically or may be associated with a     variety of genetic syndromes such as Multiple Endocrine Neoplasia Type 1, Carney Complex,     familial isolated pituitary adenoma (FIPA) and Mc-Cune Albright Syndrome. The accompanying     features of these syndromes and family history are helpful in the differential diagnosis.     Aryl hydrocarbon receptor (AHR)-interacting protein (AIP) gene mutations can be seen     sporadically as well as in FIPA. But the prescience of the presence of AIP mutation is     limited by positive family history and early-onset of acromegaly. Furthermore, the     probability of the patient to be the index case of the family should not be ignored.      Screening for AIP gene mutation is recommended in patients with pituitary adenomas of     childhood-onset, GH or prolactin secreting tumors who are diagnosed before the age of 30     years and positive family history in two or more family members according to present evidence     in the literature. It is also known that AIP mutation is usually associated with more     aggressive clinical behavior due to unclarified reasons.      The prevalence of AIP mutation in Turkish population and types of mutations have not been     defined previously. The primary aim of the present study is to define the AIP gene mutation     prevalence and the relation with clinical and tumour behaviour in a subgroup of Turkish     acromegalic patients. If AIP gene mutation is detected in some patients, it will be possible     to screen the family of the patient for the presence of AIP mutation or at least for the     presence of pituitary adenoma.      Acromegalic patients who are followed in Erciyes University Medical School Department of     Endocrinology will be enrolled into the study. After DNA isolation, each exon of AIP gene     including splicing points will be reproduced by polymerase chain reaction (PCR) and will be     analyzed for the presence of mutation by sequence analysis. The cases will be analyzed     further in means of clinical features according to presence of AIP gene mutation.      The prevalence of AIP gene mutation, clinical reflection of presence of AIP mutation will be     determined and genetic consultation will be given to the carriers of AIP gene mutation at the     end of the study.   "
105709|NCT01902407|"     The purpose of this research study is to develop a way of predicting with computers how     surgery on the airway will affect night time breathing called Obstructive Sleep Apnea (OSA)     in children with Down Syndrome.      Subjects will be in the research study for approximately a year. Participation in this     research study will involves a screening visit and 1 overnight sleep study (PSG) for research     purposes that will be done before airway surgery. During the research sleep study, a     measurement will be taken for airway resistance. A research measurement for airway resistance     will also be done during the clinical sleep MRI. The airway resistance measurement will take     about 10 minutes and is done during sleep. The airway resistance measurement is called     critical closing pressure (Pcrit).   "
105803|NCT01901172|"     This multicenter, open-label study will evaluate the effect of posaconazole on the     pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781     formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with     solid tumors.   "
134123|NCT01529294|"     This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone     in subjects with mild or moderate hepatic impairment comparatively to healthy matched     subjects   "
105710|NCT01902394|"     The purpose of this study is to determine if substituting whole grains for refined grains in     the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria     in the gut, and has beneficial effects on immune function, digestive health, cardiovascular     health, regulation of body weight and composition, and vitamin K status.      The investigators hypothesize that whole grain consumption over a period of 6 weeks will     alter the gut microflora toward a more beneficial bacterial profile, improve the immune     response while reducing oxidative stress and inflammatory markers, have favorable effects on     factors influencing the regulation of body weight and composition,increase bacterial vitamin     K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption,     vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is     hypothesized that, consumption of whole grains will alter statin pharmacokinetics by     decreasing rate of statin absorption, resulting in more sustained plasma concentrations.   "
105711|NCT01902381|"     This pilot clinical trial studies 6, 8-bis (benzylthio) octanoic acid (CPI-613) in treating     patients with myelodysplastic syndromes who failed previous therapy. Sometimes when     chemotherapy or biological therapy is given, it does not stop the growth of tumor cells. The     tumor is said to be resistant to treatment. 6, 8-bis (benzylthio) octanoic acid may interfere     with the growth of tumor cells and may be an effective treatment for myelodysplastic     syndromes that did not respond to previous therapy.   "
105712|NCT01902368|"     The purpose of this study is to see if it makes sense to test people for celiac disease who     have a first or second degree relative (parent, sibling, child, grandparent, aunt or uncle)     with celiac disease. The investigators will check to see what differences there are in the     health and quality of life between those who know they have celiac disease and start the     gluten free diet and those who do not.   "
105713|NCT01902355|"     The purpose of this study is to compare two needle insertion techniques(Seldinger vs.     modified Seldinger technique) on success rate and complications during central venous     catheterization.   "
105715|NCT01902329|"     This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered     as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of     the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not     cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML).     The MTD will be determined by observing the dose-limiting toxicities (the side effects that     prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and     anti-leukemia activity of SGN-CD33A will be assessed.   "
105716|NCT01902316|"     Although diabetes has been controlled since insulin became available, it is still considered     incurable and poses serious threats to human health. Reports have suggested that the     hyperglycemic condition of patients with diabetes mellitus may be greatly alleviated or even     reversed if it could be controlled at an early stage of diabetes. Thus, early detection and     diagnosis of diabetes and prediabetes are become increasingly important in the treatment and     prevention of diabetes. Diabetes mellitus is currently diagnosed by recurrent or persistent     hyperglycemia. In an effort to identify novel biomarkers for diabetes, research has shown     that neither plasma glucose nor glycated hemoglobin (HbA1c) levels are unable to be used in     the early detection of diabetes. In this work, the investigators have found 8 biomarker     candidates by developing a standard-free, label-free MS-based proteomics method based on     standard protein (human serum albumin, the highest abundance protein in human plasma) model     in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical     plasma samples to see if there is significant quantitative difference between normal people     and diabetes patients.   "
105717|NCT01902303|"     The purpose of this study is to determine if a new drug treatment is effective to block the     development of a cold sore lesion following Ultra Violet (UV) exposure.   "
105718|NCT01902290|"     The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective     compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite     scores.   "
105719|NCT01902277|"     ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical     workflow of the ICU. Effective healthcare resource planning requires reliable (i.e.,     multicentre) data that can inform on both of these.      The purpose of this study was to determine the impact of ICU delirium in terms of both     patients and beds. The study was carried out prospectively, over a one-week period, at adult     ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).   "
105720|NCT01902264|"     The objective of this study is to compare the red blood cell (RBC) and plasma concentrations     of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus     levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.      Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before     and in the first few weeks of pregnancy has been shown to reduce certain types of birth     defects. This is important for women who may become pregnant following discontinuation of     oral contraception. Information about any side effects that may occur will also be collected.   "
105721|NCT01902251|"     A multiple dose relative bioavailability study in patients with prostate cancer comparing a     capsule and a tablet formulation of enzalutamide.   "
105722|NCT01902238|"     The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation     for the treatment of pancreatic NET   "
105723|NCT01902225|"     This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy     study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in     combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or     refractory cutaneous T-cell lymphoma after at least 2 lines of skin-directed therapy or one     prior line of systemic therapy. Patients will be treated with Doxil 20mg/m2 on day 1 and     romidepsin 8-14mg/m2 on days 1, 8 and 15, every 28 days, until 2 cycles beyond the best     response, 8 cycles, disease progression or intolerability whichever comes first. Importanly,     doxil is administered prior to romidepsin on day1 of each cycle. Patients will be followed     until disease progression or death whichever comes first.   "
105724|NCT01902212|"     The objective of this study is to capture gastrointestinal tolerance (GI) information on a     nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.   "
105725|NCT01902199|"     A randomized control trial evaluating a novel smoking cessation intervention in individuals     at a an inpatient clinic for clients with addiction and concurrent disorders. The     intervention is based on cognitive bias modification, where participants are explicitly or     implicitly trained to make avoidance movements by pushing a joystick in response to pictures     of smoking, and as a result altering their cognitive biases towards smoking and tobacco     dependence.      Hypothesis: Participation in the experimental (tobacco-avoidance) condition will induce     reduction of smoking, assessed as lower levels of carbon monoxide measured at baseline and 12     week follow-up.   "
105726|NCT01902186|"     Given the high prevalence of bone alteration in the course of HIV infection or antiretroviral     treatment and the favourable properties of raltegravir the investigators designed this pilot     randomized and controlled study. Adult female HIV-positive patients on successful treatment     with tenofovir/emtricitabine plus atazanavir plus ritonavir will be randomized either to     continue such a regimen or to switch to raltegravir plus atazanavir plus ritonavir. Bone     mineral density changes will be compared in the two groups at 48 weeks: the hypothesis is     that removing tenofovir and using tenofovir will increase bone mineral density at 48 weeks.   "
105727|NCT01902173|"     This phase I/II trial studies the side effects and the best dose of Akt inhibitor GSK2141795     when given together with dabrafenib and trametinib and to see how well they work in treating     patients with stage IIIC-IV cancer. Akt inhibitor GSK2141795, dabrafenib, and trametinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     Akt inhibitor GSK2141795 with dabrafenib and trametinib may be a better treatment for cancer.   "
105728|NCT01902160|"     This phase I trial studies the side effects and best dose of temsirolimus when given together     with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned or has     not responded to treatment. Temsirolimus may stop the growth of cancer cells by blocking some     of the enzymes needed for cell growth. Biological therapies, such as brentuximab vedotin, may     stimulate the immune system in different ways and stop cancer cells from growing. Giving     temsirolimus with brentuximab vedotin may work better in treating patients with Hodgkin     lymphoma.   "
105729|NCT01902147|"     Recovery following general anesthesia and surgery is a complex issue confounded by the type     of surgery, surgical care, inflammation, different anesthetic drugs and techniques, patient     co-morbidities, and differing patient and clinician perceptions of what constitutes good     recovery. In this observational study, quality of recovery and patient satisfaction will be     measured using the Postoperative Quality Recovery Scale (PQRS). This tool includes six     domains of recovery: physiological, nociceptive (pain and nausea), emotive (anxiety and     depression), functional recovery (return of activities of daily living), self-assessed     recovery, and cognitive recovery.   "
105730|NCT01902134|"     This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed     combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison     to the single agents (and placebo for the single dose phase only) Approximately 600 male and     female patients presenting moderate to severe pain after an elective primary hip arthroplasty     are eligible to be randomised provided that they experience moderate to severe pain on the     day after surgery.   "
105731|NCT01902121|"     A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to     evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and     administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U     cartridge.   "
105732|NCT01902108|"     The objective of this prospective randomized double-blind study is to evaluate the added     analgesic value of clonidine to the conventional local bupivacaine wound infiltration in     posterior spine surgery.   "
105733|NCT01902095|"     Dental plaque, known as dental biofilm, is implicated as the primary etiological agent     responsible for oral inflammatory diseases. Matured form of dental plaque plays a major role     in the pathogenicity of gingivitis; if not managed in early stages it results in a cascade of     events leading to the destruction of periodontal tissues.      Effective plaque control techniques have been suggested that maintain dental biofilm at     levels compatible with oral health and is the cornerstone for all preventive strategies to     control oral diseases particularly gingivitis. To clean teeth and ensure effective plaque     control, different mechanical means have been in use since centuries. However because of an     inadequacy in plaque removal, different antimicrobial and antiplaque agents have been     introduced in oral-care products.      The use of dentifrices has been recommended over the years as the ultimate way of preventing     the incidence of oral diseases. Dentifrices have the anti-plaque and the anti-gingivitis     capabilities due to their composition. Toothpastes and to a lesser extent toothpowders are     common oral-care products used to eliminate plaque and other deposits from tooth surfaces.     Existent literature has focused more on toothpaste and mouth rinse and derelicts toothpowder     despite its difference owing to the absence of humectants. With the intention to advance the     knowledge on this issue as well as close the research gap, this study was conducted to     evaluate the efficacy of toothpowder in alleviating gingivitis, controlling dental plaque,     and inhibiting extrinsic stains.      A single-blind, parallel arm randomized controlled trial (RCT) evaluated the efficacy of     toothpowder against toothpaste through oral hygiene parameters of plaque and stain deposits     on teeth and gingival inflammation. Plaque Index, Lobene Stain Index and Gingival Index were     used as measures of oral hygiene.      The current RCT revealed that toothpowder and toothpaste were equally effective in both     treatment and control groups from clinical perspective however toothpowder showed a     statistically significant effectiveness as compared to toothpaste. Toothpowder, composed of     calcium carbonate and essential oils, has demonstrated to be statistically more effective     than toothpaste in controlling extrinsic dental staining, dental plaque and gingival     inflammation.   "
105734|NCT01902082|"     Currently, there is no proven effective pharmacologic treatment available for patients with     the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be     effective in treating several inflammatory diseases. The main purpose of this study is to     assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.   "
105735|NCT01902069|"     The aims of this project are to:        1. Determine if 3-weeks dietary supplementation with NOPE-EGCG (PhosphoLEANtm, 85mg          NOPE+50mg EGCG per capsule) versus a placebo will improve performance on impulsivity,          go/no-go tasks and negative outcome learning in heavy drinkers.        2. Evaluate whether supplementation with NOPE-EGCG versus placebo results in reductions in          alcohol consumption.        3. Preliminary data in the rodent model suggests that rats treated with OEA shift          preference for lower fat test stimuli. In aim 3 we will Determine if 3-weeks of          supplementation with PhosphoLEAN shifts fat preference towards lower fat test puddings.   "
105736|NCT01902056|"     The purpose of this study is to compare the effect on soft tissue thickness of placing either     a single or double layer of acellular dermal matrix simultaneous with dental implant     placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker     tissues that one layer.   "
143003|NCT01412606|"     Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase     pregnancy rate in women with unexplained infertility.   "
105737|NCT01902043|"     Chronic disease care requires good collaboration between healthcare providers, teamwork,     self-management education and use of evidence-based medicine. However, such care process is     complex and often suboptimal. Diabetes, a prevalent chronic disease (~ 9% worldwide) which     represents a major public health burden in terms of morbidity, disability and mortality, is     not an exception. Individuals with diabetes, require more health care resources than people     without diabetes. Improving quality of diabetes care is especially needed to reduce the     health and societal burden of this disease.      In the canton of Vaud, Switzerland, a state with more than 700,000 inhabitants, a recent     population-based study has shown that the prevalence of diabetes was around 7%. Data on the     quality of diabetes care is scarce and quality of care data are still infrequently and     unsystematically collected in Switzerland. In addition, when they are available, they rather     focus on intermediate outcomes as well as clinical and biological cardiovascular risk     factors. Also, they are not population-based and do not consider patient-reported outcomes.      In 2010, the Public Health Department of the canton of Vaud initiated the development of a     regional diabetes program entitled Programme cantonal Diabète (PcD). It aimed both at     decreasing the incidence of diabetes and at improving care for patients with diabetes.      To better tailor the program to the healthcare needs of patients and healthcare professionals     involved in diabetes care, an exploratory study using qualitative methods was conducted in     2010. This was followed by a population-based survey conducted in fall 2011 and summer 2012.     The objectives of this survey were to characterize patients with diabetes and assess the     quality of the care they received. In addition, to help targeting unmet needs and possible     areas of improvements, the results of this survey also constituted the baseline patients'     measurement of the evaluation of the PcD.      The CoDiab-VD cohort emerged from that initial project. Its specific objectives are 1) to     follow over time quality of diabetes care, 2) to assess the impact of the PcD on care of     patients with diabetes, and 3) to evaluate the coverage of the PcD within the canton of Vaud.   "
105738|NCT01902030|"     Although being a frequent and lethal complication in patients (pts) with hematologic     malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as     culture-based methods show low sensitivity especially under the current clinical practice of     antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing     biopsies for identification of the underlying infectious organism becomes important. However,     as culture-based methods only yield results in a minority of patients, using     non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for     detection of IA directly in clinical specimens is becoming increasingly important and might     help to characterize the causative pathogen.      Therefore the performance of an established Aspergillus-specific nested PCR in biopsies,     re-section material or pleural effusions is evaluated.   "
105739|NCT01902017|"     Injured joints, especially at the elbow, are at risk for permanent motion loss, also known as     joint contractures. Joint contractures limit the function of an elbow and are a recognized     complication that occurs often after a traumatic injury. The benefits of early motion after     injury has helped in preventing joint contractures but there are still several patients that     develop debilitating joint contractures. Current research suggests that mast cells, which are     found in the joint, are key in causing joint contractures. Research has been done using a     medication called Ketotifen. Ketotifen has been linked to stabilizing mast cells and     preventing the joint contracture. It is hoped that short-term use of this medication after an     injury will prevent the contracture from occurring.   "
105740|NCT01902004|"     The proposed project will evaluate the role of neuroimaging biomarkers of brain aging (i.e.,     neurodegenerative and vascular brain changes) and mild cognitive impairment in the patterns     of treatment response to memantine combined with escitalopram compared to escitalopram and     placebo.   "
105741|NCT01901991|"     Each year the Danish mammography-screening programme identifies a large number of patients     with small non-palpable breast cancers or precancerous lesions. The majority of these     patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the     suspicious lesion completely without removing excess healthy breast tissue. To obtain this     accurate lesion localization is essential.      Until today the standard procedure in Denmark has been wire guided localization (WGL).     Although the method has been utilized for a number of years it has several disadvantages.     Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and     subsequently reoperation. It can postpone the additional systemic treatment, offered after     the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for     the patient and the departments involved. The wire needs to be placed on the day of the     operation, which decreases the flexibility of the procedure.      The purpose of this study is to test a new method named radioactive seed localization (RSL).     The method uses a small titanium seed containing radioactive iodine. It will be placed in the     centre of the lesion, and during the operation, the surgeon can locate it with a handheld     gamma probe. The seed can be placed a few days in advance, which means a more flexible course     of treatment. The method seems promising with regards to reoperation rates, but it needs     further testing.      Hypothesis:      RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL.     Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced     number of re-operations.      The study will be performed as a randomised clinical trial, where the two methods will be     compared to each other. The trial will be performed at the department of breast surgery at     Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation     rates, duration of the surgical procedure and the amount of removed breast tissue will be     compared.   "
105742|NCT01901978|"     The purpose of this study is to investigate the changes in subcutaneous adipocyte size,     number and gene expression after weight loss and to assess whether those changes contribute     to decreases in ectopic fat accumulation and insulin resistance in women between ages of     16-32.   "
105743|NCT01901965|"     The main aims of the study are (1) to examine the impact of contralateral strength training     on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of     cross-education induced by NMES versus eccentric strength training.   "
105744|NCT01901952|"     The primary aim of the LIFE study is to compare low-income African American diabetes patients     in a lifestyle intervention group with those in a standard of care control group on change in     glycemic control at 12-months. We hypothesize that, on average, participants in the     intervention group will achieve greater glycemic control at 12-months relative to their     baseline A1c, than those in the control group.   "
105745|NCT01901939|"     The proposed preliminary study from this interdisciplinary team will provide important     information about the feasibility and safety of bedside low intensity pedaling exercise     during hospitalization. The findings from this study are essential to develop high-value,     effective treatments that can be used by any hospital setting throughout the country. The     program that investigators are proposing may provide important changes in how disability can     be prevented in elderly patients who are hospitalized because of an acute illness.   "
105746|NCT01901926|"     The purpose of this study is to determine the effects of non surgical periodontal treatment     on glycemic control in type II diabetics.   "
105759|NCT01901744|"     The study evaluates contrast sensitivity in older children following surgery for lamellar and     posterior subcapsular cataracts. Often, pediatric surgeons tend to delay surgery in these     children who present beyond the amblyogenic age group. These cataracts are often compatible     with reasonable visual acuity and therefore some surgeons prefer to wait for surgery, whereas     others tend to operate.      The study evaluates improvement in contrast sensitivity at different spatial frequencies     following cataract surgery for lamellar and posterior subcapsular cataracts in older     children.   "
105747|NCT01901913|"     The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose     levels by delivery of insulin operable in clinical trial settings. The safety of the system     was proved in previous inpatient and outpatient trials in large number of patients. In the     current study we aim to optimize post-prandial closed-loop glycemic control by developing an     automated MD-bolus calculator and to evaluate its safety and efficacy in controlling     postprandial blood glucose when used together with the MD-Logic artificial pancreas system in     type 1 diabetes patients.      The study will consist of a pilot study with two segments and a main study segment. The aim     of each segment is detailed below:        1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate          the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop          operation with no meal announcement.        2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to          test the optimal distribution of insulin delivery during the meal.        3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we          will use the results and conclusions from the previous two pilot segments to develop the          MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this          automated insulin bolus calculator will be tested in a randomized cross-over study that          will compare postprandial glycemic control under MDLAP with and without the use of the          MD-Bolus Calculator.   "
105748|NCT01901900|"     This extension study will provide continuing treatment with secukinumab for up to 3 years for     subjects who completed the phase III core study, CAIN457F2302. Subjects will be offered     maintenance treatment with secukinumab at the 150 mg given subcutaneously every 4 weeks. The     study aims to obtain further long term efficacy, safety and tolerability information on     secukinumab for patients with rheumatoid arthritis.   "
105822|NCT01900925|"     There will be two groups of patients with low back pain (by randomization). Both groups will     receive a pragmatic treatment approach by physical therapists for low back pain. One group     will also receive a prescriptive treatment approach for both hips. The investigators feel     that the additional of a standardized exercise program and stretching for the hips will     improve outcomes in patients with mechanical low back pain.   "
105749|NCT01901887|"     The BRAVO study seeks to determine if dietary supplementation with omega-3 highly unsaturated     fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors, suicidal     thinking, negative emotions, and symptoms associated with suicide risk, in a Veteran and     non-Veteran population that is at risk for suicidal behaviors. This study seeks to evaluate     the efficacy of omega-3 HUFAs among a representative population of US Veterans and     non-Veterans already receiving appropriate medical care so that if successful, these results     can be readily applied to broader populations in the US.   "
105750|NCT01901861|"     study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of     increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2     diabetes. To this purpose, a standardized mixed meal test will be ingested with or without     concomitant administration of sitagliptin (100mg).   "
105751|NCT01901848|"     Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with     significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though     research suggests smoking is linked with PTSD symptoms, existing smoking cessation treatments     targeting PTSD smokers do not include PTSD treatment. The purpose of this study is to examine     a treatment that combines evidence based treatment for PTSD (cognitive processing therapy, or     CPT) with smoking cessation treatment for PTSD and a mobile text messaging program. The study     objectives are to evaluate feasibility of the treatment and to examine effectiveness of CPT     and smoking cessation treatment combined compared to smoking cessation treatment without CPT.     Fifty Veteran smokers with PTSD will participate in fourteen study sessions, ending with the     final follow-up session six months after the scheduled quit date.   "
105752|NCT01901835|"     This randomized clinical trial studies media diversion in improving quality of life in     patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may     improve mood and quality of life in patients having cancer treatment.   "
105753|NCT01901822|"     The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix     using a continuous sling suture to secure both the graft and the flap will result in better     percent root coverage compared to the continuous sling suturing technique to secure the graft     and the flap separately.   "
105754|NCT01901809|"     Heart Failure with preserved Ejection Fraction (HFPEF) accounts for 40-50% of all heart     failure patients with a frequency of hospital admissions for acute decompensation and short     and long term mortality similar to patients with heart failure with reduced ejection fraction     (HFREF). Patients with HFPEF are often preload dependent and despite admission to the     hospital for acute decompensated heart failure (ADHF), are typically difficult to diurese due     to the development of acute kidney injury. No studies have been performed evaluating     treatment strategies for these patients. We hypothesize that changing the method of diuresis     and/or the addition of low-dose dopamine for the treatment of ADHF in patients with HFPEF     will reduce renal injury, resulting in a shorter length of stay, and decrease hospital     readmissions over the ensuing year. This trial will randomize patients to either bolus or     continuous infusion furosemide and then to either dopamine or no dopamine. The primary     endpoint will be renal function at 72 hours as measured by change in GFR. Secondary endpoints     for readmission, functional capacity, quality of life, and amount of diuresis will also be     collected.   "
105755|NCT01901796|"     We hypothesize that the intervention will: (1) offer a feasible approach for providing mental     healthcare to pregnant women and have a high level of acceptability by pregnant women and     healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting     stress; improve parenting competence, coping, and relationship adjustment compared to usual     care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early     intervention holds promise for reducing maternal mental health morbidity and its negative     influences on infants, children, and families.   "
105756|NCT01901783|"     This study is designed to compare the clinical and histologic results of ridge augmentation     with and without primary closure over the barrier membrane. The hypothesis is that there will     be no difference in crestal ridge width between the two groups.   "
105757|NCT01901770|"     This clinical trial studies an educational intervention for parents and providers in     increasing human papillomavirus (HPV) vaccination rates in younger girls in Ohio Appalachia.     Educational interventions may be effective in increasing the number of participants whose     daughters receive HPV vaccination.   "
105758|NCT01901757|"     To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in     fed versus fasted condition   "
105762|NCT01901705|"     Psoriasis is a common, chronic skin disease for which only remissive, as opposed to curative,     treatments are available. Traditional Chinese medicine is one of the most frequently chosen     alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with     topical and oral herbal preparations. Topical indigo naturalis ointment has been reported to     exhibit potential anti-psoriatic efficacy. The study objective is to investigate     pharmacological effect and explore targeting mechanisms of Traditional Chinese Medicine (TCM)     Indigo Naturalis topical ointment as a single treatment agent in Chinese subjects with mild     to moderate plaque-type Psoriasis.      This was a single site, randomized, double-blinded, placebo controlled study of topical     indigo naturalis vs. vehicle alone (placebo) to treat mild to moderate plaque-type psoriasis     during an 8-week period. Pharmacological effect will be evaluated by biomarker evaluation and     clinical evaluation. The trial was conducted at the China Medical University Hospital (CMUH),     Taichung, Taiwan. All patients provided written informed consent before inclusion in the     study. The study protocol was approved by the institutional review board (IRB) of CMUH.   "
105763|NCT01901692|"     To evaluate and compare the efficacy and safety of trans-arterial chemoembolization plus     external beam radiation therapy and sorafenib in patients with hepatocellular carcinoma     invading major intrahepatic vessels   "
105764|NCT01901679|"     The study plans to find out whether Celebrex may be potentially useful to decrease     inflammation in fat tissues and thereby lower the production of substances such as estrogens     that may increase the risk of developing breast cancer and lead to a poor outcome of the     disease.   "
105765|NCT01901666|"     CML is a myeloproliferative disorder defined by the presence of the Philadelphia chromosome,     which arises from the reciprocal translocation of genes on chromosomes 9 and 22.It is rare in     childhood and accounts for 2-3% of all leukemias in childhood.      BCR-ABL gene on Philadelphia chromosome results in a 210kd fused BCR-ABL protein with     constitutive tyrosine kinase activity, and subsequent activation of cytoplasmic and nuclear     signal transduction pathways including STAT, RAS, JUN, MYC, and phosphatidylinositol-3     kinase. The ultimate result of such activation is the myeloid proliferation and     differentiation and suppressed apoptosis.      Children present with a higher WBC count, otherwise presentation is nearly identical to     adults. Current treatment include tyrosine kinase inhibitors (TKI) and allogeneic stem cell     transplant (SCT).Imatinibmesylate inhibits the tyrosine kinase (TK) activity of BCR-ABL1 and     several related TKs, including c-kit and the platelet-derived growth factor receptor (PDGFR).     Development of tyrosine kinase inhibitor (TKI) therapy has revolutionizedtreatment of CML.     Imatinib or second generation TKIs (dasatinib or nilotinib) have become standard front-line     therapy forchildren and adults with CML and are also important componentsof therapy for Ph+     acute lymphoblastic leukemia (ALL).      TKIs are administered orally and cause a number of side effects including fatigue,     hypertension, rash, impaired wound healing, myelosuppression, and diarrhea . The overall     toxicity of TKIs, while less life-threatening than conventional cytotoxic chemotherapy,     nevertheless is common, and may require dose reduction.Recently, proposed endocrine-related     side effects of these agents include alterations in thyroid function, bone metabolism, linear     growth, gonadal function, fetal development, glucose metabolism and adrenal function.      Growth impairment is one of the major adverse effect of long-term imatinib treatment in     children with CML. Multiple case reports have demonstrated growth retardation in children     onimatinib.Imatinibmesylate inhibits the TK activity of BCR-ABL1 and several related TKs,     including c-kit and theplatelet-derived growth factor receptor (PDGFR). It isthe inhibition     of TK activity at the non-BCR-ABL sites that couldbe the likely cause for the adverse effect     on growth. Severalstudies in adults have suggested that inhibition of c-kit,c-fms, and PDGF     receptors results in modulation of bone metabolism. Other reports are focusing on disturbance     of the growth hormone (GH) axis as a mechanism for growth impairment. Receptor and non     receptor TK is expressed at multiple levels in GH-IGF-1 axis including GHRH-R, GH-R and     IGF-1R. Inhibition of TKs with TKI, at any one of these level, might result in growth     impairment.      Various studies are available to show that Imainib therapy may cause short stature in     children on prolonged treatment but exact mechanism by which this occurs is still not clear.     Further, no treatment modality has been tried so far, for short stature in these children.      So, the purpose of this study is to study GH-IGF1 axis in these children and to administer GH     therapy to GH deficienct children in remission.   "
106361|NCT01893840|"     A study to assess the effect of negative pulsating pressure therapy on patients with impaired     blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase     the blood flow to the leg in these patients.   "
105766|NCT01901653|"     The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different     dose levels in patients with small cell lung cancer whose cancer has progressed or recurred     following standard chemotherapy. Once a safe and tolerable dose is determined, the     anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor     shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a     protein that appears to be expressed on the surface of most small cell lung cancers that have     been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of     chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's     theoretically provide more precise delivery of chemotherapy to cancer cells, possibly     improving effectiveness relative to toxicities.   "
105767|NCT01901640|"     Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose,     6-month extension study (parent study : DA8159_EDD_III)   "
105768|NCT01901627|"     A multicenter registry to explore the clinical outcome of Chinese adult patients with active     Ankylosing Spondylitis *AS* treated with adalimumab,prescribed according to the local     label,in the real world practice   "
105769|NCT01901614|"     The purpose of this study is to determine if a new procedure, called laser-assisted lamellar     anterior keratoplasty (LALAK), can achieve the same level of vision with a lower risk of     potential complications after surgery compared to another corneal transplant procedure. The     current procedure is called Intralase-enabled keratoplasty (IEK) and replaces the entire     cornea.      The LALAK procedure involves transplanting only the top layers of the cornea instead of the     entire cornea. Only one eye will have this experimental procedure performed. If both eyes     need to have surgery your doctor will help you decide on the best non-study option for your     other eye.   "
105770|NCT01901601|"     The purpose of this protocol is to compare and develop new surgical technique of     partial-thickness corneal transplantation for treating corneal opacity. A newly developed     technique, dovetail laser-assisted lamellar anterior keratoplasty (LALAK), will be tested     and compared with standard full-thickness corneal transplantation, Intralase-enabled     keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea and     does not have the risks associated with conventional IEK. Additionally, optical coherence     tomography (OCT) will be used to guide the depth of the graft and donor dissections.      The data will be analyzed to understand whether the new technique (LALAK) can repeatedly     achieve good visual outcomes with lower risk from the operation compared to the visual     outcomes and risk associated with the current standard of care, IEK.   "
105771|NCT01901588|"     This study is trying to see if using precedex pre-operatively prevents emergence delirium in     pediatric (ages 1-7) patients undergoing strabismus surgery.   "
105772|NCT01901575|"     Determine effects of remifentanil conscious sedation in patients undergoing     Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia     and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin   "
105773|NCT01901562|"     In this prospective clinical trial, patients who sign an approved informed consent for     ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the     study. Consented patients who have been diagnosed with a solitary papilloma within the     discharging duct will be recruited to have interventional ductoscopy.      Patients who are identified ductoscopically with a solitary non-sessile papilloma will     undergo an attempted ductoscopic papillomectomy (DP). Patients with ductoscopic findings     other than single non-sessile papilloma will undergo standard ductoscopically guided     microductectomy. The investigators will investigate whether the ductoscopic basket can be     used as a safe endoscopic extraction instrument without adverse events. Histopathological     evaluation will be performed to confirm the ductoscopic diagnosis and to determine the     existence of any malignant tissue.   "
105774|NCT01901549|"     This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure     and left ventricle remodeling progression in patients after acute coronary syndrome.   "
105775|NCT01901536|"     This is a research study to evaluate the effectiveness of the Family Foundations program and     to better understand how families cope with having a new baby. The research questions     include: What is the effectiveness of the Family Foundations program? How do families cope     with having a new baby?   "
105776|NCT01901523|"     Clinical research, like all science, is self-correcting, with errors detected by the     scientific community and communicated to the publishing journals, which then relay the     information (and its resolution) to its readers. If this relaying process fails, science     grinds to a halt. In this study we are testing its integrity.   "
107702|NCT01876693|"     The purpose of the study is to determine whether prophylactic gastrostomy leads to less     treatment interruption and provide better quality of life in head and neck cancer patients     receiving chemoradiotherapy.   "
105780|NCT01901471|"     The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced     by tissue reperfusion. These reperfusion's injuries can be reduced by injection of     cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final     infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by     cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock     improves short-term and long term survival by reducing the size of the myocardial infarction.     The hypothesis of this study is that the administration of Cyclosporin A to these patients,     in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ     failure associated with the cardiogenic shock and improve clinical outcome.   "
105781|NCT01901458|"     The study will determine the advantage of the Spectra Optia® IDL set compared to the standard     collection set for collection of peripheral blood progenitor cells using the Spectra Optia®     apheresis system. The study will assess the reduction of apheresis time to obtain the     required amount of hematopoietic progenitor cells.   "
105782|NCT01901445|"     The purpose of this study is to determine if the quality of life in children and adolescents     diagnosed with chronic functional constipation improves after educational activity in focus     group composed by these patients' mothers.   "
105991|NCT01898702|"     The purpose of this study is to determine whether participation in a diabetes expert patients     programme course is effective in self-management of a chronic condition such as diabetes, if     it reduces Haemoglobin A glycosylated levels, improves patient's quality of life, and     prevents the use of some health services.   "
105783|NCT01901432|"     This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the     safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in     patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while     Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or     Part B and transition from one part to the other is not allowed.      Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera     according to the revised World Health Organization criteria. Only if the enrolment in Part A     is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may     be expanded to all patients with chronic myeloproliferative neoplasms.      Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response     will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e.     at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study.     All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess     the clinico-haematological response.      The study will last up to a maximum of 24 weeks of treatment. However, after completion of     the trial, all patients achieving clinical benefit will be allowed to continue treatment with     Givinostat (at the same dose and schedule) in a long-term study.      Safety will be monitored at each visit throughout the entire duration of the study. Treatment     will be administered on an outpatient basis and patients will be followed regularly with     physical and laboratory tests, as specified in the protocol; in case of hospitalization, the     treatment will be continued or interrupted according to the Investigators' decision.   "
105784|NCT01901419|"     Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin     trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic     inflammatory response, while insufficient and delayed neutralization of heparin by protamine     may contribute to more blood loss during rewarming stage.      Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment     for unstable angina, myocardial infarction, congestive heart failure, and perioperative     hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin     infusion during rewarming corrects systemic ischemic stress and facilitates heparin     neutralization in cardiac surgery.   "
105785|NCT01901406|"     Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old     population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and     epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but     nowadays with technical improvement and surgical instrument renovation, it seems to have been     changed the surgical indication. Therefore, we plan to evaluate the changes of binocular     visual acuity, aniseikonia in patients with epiretinal membrane.   "
105786|NCT01901393|"     The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to     ketorolac for the treatment of postoperative pain as measured by patient pain intensity     (Visual Analog Scale, VAS)   "
105787|NCT01901380|"     Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an     estimated incidence ranging between 2% and 3% in infants and marginally lower in older     children. It has been demonstrated that it could be a risk factor for the development of the     functional gastrointestinal disorders in children. Intestinal microflora has been indicated     as potential target for the management of CMA and FGDIs through the use of probiotics.     Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been     demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following     the addition of LGG, satisfying both the American Academy of Pediatrics guidelines.     Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein     formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved     recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster     induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and     exerted at different levels: epithelium, immune system and enteric nervous system. Studies     and meta-analyses showed that LGG increases treatment success in children with functional     gastrointestinal disorders.   "
105788|NCT01901367|"     This randomized pilot phase II trial studies how well nutritional intervention and exercise     intervention works in preventing metabolic syndrome in younger patients with acute     lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of     life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of     being tired caused by cancer, may help improve strength, and may help build up lost muscle     tissue. Nutritional intervention plus exercise intervention may be effective at preventing     metabolic syndrome.   "
105804|NCT01901159|"     This randomized, open-label, cross-over study will assess the bioavailability and safety of     RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet     and capsule) of the study drug under fed and fasting conditions.   "
105805|NCT01901146|"     The purpose of this research study is to compare the effectiveness and safety of ABP 980     against trastuzumab in women with early breast cancer.   "
134303|NCT01526915|"     The main objective of our study is to assess, after tooth extraction, the efficacity of PRF     in the prevention of healing delay and of jawbone osteochemonecrosis induced by     bisphosphonates   "
105789|NCT01901354|"     This study will compare two ventilator modes in mechanically ventilated patients with acute     lung injury.      Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able     to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI.     ALI causes 75,000 deaths in the US each year.      Ventilators can be set to work in different ways, called modes. One mode, called ARDSNet,     pumps a small amount of air into the patient's lungs and then most of the air is released     prior to the next breath. Another mode, called Airway pressure release ventilation (APRV),     keeps air in the lungs longer between breaths. Both of these modes are currently used at this     hospital. The investigators think APRV may help patients with ALI, but we do not know for     sure.   "
105790|NCT01901341|"     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment     of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer     pain.   "
105791|NCT01901328|"     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment     of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer     pain.   "
105795|NCT01901276|"     The colonic microbiome is essential in human health and disease. Clostridium     difficile-associated diarrhea (CDAD), a highly morbid form of infectious diarrhea, is caused     by antibiotics which perturb the microbiome and allow C. difficile to proliferate. Proton     pump inhibitors (PPIs) are powerful suppressors of gastric acid and among the most common     medicines in the United States. Dozens of observational studies show that longterm PPI use is     associated with CDAD. However, the mechanism by which PPIs cause CDAD is unknown. We believe     that PPIs cause CDAD by inducing alterations in the human colonic microbiome. We will confirm     or refute the hypothesized mechanism for the association between PPIs and CDAD using an     unblinded, single-armed study design. We will use pyrosequencing of the hypervariable V4     region of the bacterial 16S ribosomal subunit gene in human fecal samples to describe the     colonic flora. We will collect fecal samples from volunteers before and after PPIs given for     different durations and test the microbiome to determine 1) whether PPIs diminish overall     diversity, 2) whether PPIs diminish relative abundance of Bacteroidetes, 3) whether increased     duration of PPIs affects diversity, and 4) whether there is recovery of diversity after     completing a defined course of PPIs. We believe that PPIs will cause a pattern of diminished     overall microbiome diversity and reduced anaerobes — the same pattern seen after use of     antibiotics. Furthermore, we believe that increased PPI duration will further diminish     diversity and that the microbiome will return to pre-PPI levels of diversity after PPIs are     stopped. These results will facilitate biologically-based clinical interventions to reduce     rates of CDAD among patients who require acid suppression.   "
105796|NCT01901263|"     Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National     Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's     disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is     promoting the evaluation of these units through the observation of the behavioral and     psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears     important to assess their long-term impact on patients care.   "
105797|NCT01901250|"     The purposes of this study is to determine whether xylitol use in kindergarten school     children in addition to oral health education, provision of tooth brush and fluoride paste,     fluoride varnish and sealant treatment will reduce decay in the first permanent molars and     other permanent teeth.   "
105798|NCT01901237|"     Adolescents and young adults who are living with cancer are not benefiting from the same     age-appropriate physical and psychosocial care, as are children and older adults. As a     result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a     lack of age-appropriate care may be responsible for a deceased quality of life. Studies have     also shown that physical activity is able to reduce many of the negative side-effects linked     to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical     activity that is both safe and manageable for cancer patients is yoga. The purpose of this     study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha     yoga program (available on DVD) in the adolescent and young adult non-curative cancer     population. This study will also examine the ability of yoga to reduce cancer related side     effects.   "
105799|NCT01901224|"     The investigators are doing this research study to find out if taking Metformin improves     walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries     (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle     can hurt in patients with PAD and this is usually described as a cramp or tiredness. This     pain is called intermittent claudication. Metformin is an FDA approved medication for the     treatment of diabetes. The investigators believe that Metformin may help your leg muscles     work better.      The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at     Brigham and Women's Hospital (BWH).   "
105800|NCT01901211|"     As children with cerebral palsy (CP) become teenagers, they experience a decrease in their     physical function and mobility. Decreased mobility leads to increased social isolation for     the teens and impacts negatively on their quality of life. This loss of function is     multifactorial, but poor physical fitness and muscle weakness secondary to disuse are     significant contributors. Exercise video games are a novel approach to engage youth in     physical exercise and social interaction with their peers. The objective of this study is to     evaluate the impact of an exercise video gaming intervention to improve physical fitness and     social wellbeing. Our over-arching research questions are whether exergames can provide     health benefits (improved physical fitness) and improved social wellbeing in youth with CP.   "
105806|NCT01901133|"     This study will assess the influence of hepatic impairment on the pharmacokinetics, safety     and tolerability of a single dose of MDV3100 in male subjects.      The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic     impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained     from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and     age-matched subjects with normal hepatic function.   "
105807|NCT01901120|"     This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name:     mirabegron), and to determine the adherence to treatment with mirabegron.   "
105808|NCT01901107|"     The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin®     Capsules in actual clinical settings.   "
105809|NCT01901094|"     This randomized phase III trial studies axillary lymph node dissection to see how well it     works compared to axillary radiation therapy in treating patients with node-positive breast     cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may     remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer.     Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate     whether radiation therapy is as effective as lymph node dissection.   "
105810|NCT01901081|"     This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to     control an electromechanical prosthetic wrist and hand.   "
105889|NCT01900041|"     Pantovigar - a high effective product designed primarily for the treatment of diffuse hair     loss in women as well as for the treatment of damaged hair, in the combined therapy can be     successfully applied in other types of alopecia.      The purpose of this study is to evaluate efficacy and tolerability of combination therapy     Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined     treatment Pantovigar plus 2% Minoxidil course therapy.   "
105811|NCT01901068|"     A great number of different suture techniques and suture materials are in use in order to     reconstitute the abdominal wall integrity, but there is no surgical gold standard for     abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials     have been performed, which compared non-absorbable or long-term absorbable versus rapid     absorbable suture materials or monofilament versus multifilament suture materials, or     continuous versus interrupted suture techniques respectively. This lack of evidence has the     following outcome: burst abdomen is observed in 1-3% of patients within the first days after     a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated     to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients     undergoing a median laparotomy within the first 30 days. At present most surgeons favour     monofilament long-absorbable continuous sutures as the most suitable material for closing     abdominal wounds after midline laparotomy.   "
105812|NCT01901055|"     Diabetes self-management is important to help adults with type 2 diabetes achieve glucose     control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a     barrier to diabetes self-management and glucose control. We will examine if treatment of     obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with     diabetes education, results in improved diabetes self-management and glucose control.   "
105813|NCT01901042|"     Radiation proctitis is quite common in treatment of pelvic tumors. We investigated whether     the use of symbiotic would prevent early symptoms of radiation proctitis and improve the     quality of life in patients undergoing radiotherapy for prostate cancer treatment. We     randomized patients to intake one sachet of either a symbiotic product containing 4.3 g of     dietary fiber and Lactobacillus reuteri in a concentration greater than 10(8)colony forming     units (CFU)(Fibermais Flora Nestlé Brazil) or sachets containing 5 g of maltodextrin. They     were instructed to dilute one sachet in 200mL of water and drink once a day during the week     before the beginning of radiotherapy sessions, and increase the dose to two sachets daily     after the beginning of the sessions for four weeks. Every week a questionnaire named EORTC     QLQ-PRT23 was applied to evaluate GI symptoms and quality of life.   "
105814|NCT01901029|"     To determine the prevalence of sexual problems particularly premature ejaculation and     erectile dysfunction among men working in factories of Dongguan city, using the self-rating     scales like International Index of Erectile Function, and to investigate the characteristics     or risk factors associated with these sexual problems in floating population through     regression analysis.   "
105815|NCT01901016|"     Prevalence of depression is higher in people living with human immunodeficiency virus (PLHIV)     than among seronegative people. Depressive symptoms have been observed in up to 40% of     seropositive population. Presence of depressive symptoms has a negative impact on quality of     life, optimal compliance of antiretroviral treatment, adoption of safe sexual behaviors, and     on immune status and viral load.      Although antidepressants and psychotherapeutic interventions -particularly those with     cognitive-behavioral components— have been proven effective in decreasing depressive symptoms     in PLHIV, their use is limited among other causes due to misdiagnosis, patient refusal,     possible interaction with antiretroviral treatments, or unavailability in the case of     psychotherapy. Furthermore, identification and assessment of more accessible interventions     that would decrease depressive symptoms and improve quality of life in PLHIV has become a     crucial objective in the management of this chronic disease.      A meta-analysis shows that relaxation is an efficient intervention to reduce depressive     symptoms in people diagnosed with depression or with high levels of depressive symptoms.     According to some authors, relaxation, an easy-to-learn and self-applied intervention, proves     to be a simple first line therapy capable of reducing depressive symptoms. However, the     amount of relaxation needed to produce an effect on depression was not established in this     meta-analysis and there are no results on the effects of relaxation in people whose     depressive symptoms were caused by other diseases and only a study which includes PLHIV.      Given the prevalence of depressive symptoms and its consequences on the health of PLHIV and     given the effects of relaxation on depressive symptoms, this pilot project aims to evaluate     feasibility and acceptability of a relaxation intervention in PLHIV who suffer depressive     symptoms, assess the feasibility and acceptability of the research project and assess the     preliminary effects of a relaxation intervention.   "
105816|NCT01901003|"     Seven French university hospitals will participate in this multicentric prospective, blinded     and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo     (microcrystalline celluloses) and no premedication at all. The third group (no premedication)     is necessary in order to evaluate a placebo response, which may be significant on anxiety     level and patients perceptions of care. It was calculated that 969 patients had to be     included in order to obtain a 5 point difference between groups on the EVAN score with 80 %     statistical power, leading to the inclusion of 1200 patients with an estimated maximum     dropout rate of 15 %. All adults below 70 years and scheduled for elective surgery under     general anesthesia can be included after information by an anesthesiologist in charge of the     study and written informed consent. Non inclusion criterions are: a weight below 45 Kg, a     counter indication to benzodiazepine, surgeries that could impair cognitive functions     (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug addiction or     former cognitive disease. The technique of anesthesia will be decided by the attending     anesthesiologist, who will be unaware of the premedication technique, independently of the     study protocol.   "
105829|NCT01900834|"     This study is conducted in the United States of America (USA). The aim of this study is to     assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D),     type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.   "
105818|NCT01900977|"     PopART is a community randomized trial that is investigating whether a community-wide     combination HIV prevention package including annual home-based HIV testing, active referral     and the offer of immediate ART for those testing HIV-positive, along with the promotion of     proven HIV prevention methods (such as voluntary medical male circumcision, prevention of     mother to child transmission and condom use), will help to prevent transmission and     substantially reduce new HIV infections. The study is being conducted in 21 communities in     Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total     population of approximately 1.2 million individuals.   "
105819|NCT01900964|"     A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane     when used for a post-extraction ridge preservation procedure to prevent the bone loss that     typically occurs. The hypothesis is that there will be no difference in the clinical and     histologic results between the two membranes.   "
105820|NCT01900951|"     Temozolomide, a nonclassic oral alkylating agent, may delay progression in sequence with     chemotherapy. This phase II trial was designed to evaluate the role of Temozolomide following     4 or 6 cycles of first-line treatment in patients with newly diagnosed SCLC.   "
105821|NCT01900938|"     The aim of this study is to compare sedation efficiency, safety and satisfaction by both     endoscopist, assistants, and the patients between continuous infusion and intermittent bolus     injection of propofol for deep sedation during ERCP.   "
105823|NCT01900912|"     Behavioral change is a key ingredient for successful adoption of better sanitation practices     in rural Africa. Sanitation programs have, for some time now, incorporated the need to raise     awareness and emphasize the benefits of toilet usage. These endeavors, often combined with     subsidies linked to toilet construction by households, seek to create a demand for sanitation     goods. Yet, progress in securing the desired outcomes from sanitation programs has been slow.     Moreover, benefits of sanitation largely take the form of externalities, which individuals do     not take into account when making their own decisions about investments. This makes     sanitation promotion at the household level particularly challenging.      A new approach to sanitation entails a shift away from the provision of subsidies for toilets     to individual households and a promotion of behavioral change at individual-level towards     emphasizing collective decision-making in order to produce 'open defecation-free' villages.     The objective of the intervention is to reduce the incidence of diseases related to poor     sanitation and manage public risks posed by the failure to safely confine the excreta of some     community members. The way to achieve this objective is by empowering communities motivated     to take collective action. Local governments and other agencies perform a facilitating role.     There is a growing recognition that this approach, referred to as Community-Led Total     Sanitation (CLTS), may help with the reduction of open defecation practices. However, no     rigorous impact evaluation of CLTS has been conducted so far. This randomized controlled     trial will study the effect of CLTS in rural Mali. As a result, sound evidence will become     available to see to what extent CLTS improves health outcomes and what is driving collective     action in order to increase sanitation coverage.      The direct recipients of the intervention are members of rural communities in Mali who aspire     to live in a cleaner environment. The donor community, international organizations, and     governments in developing countries will benefit from having simple and clear evidence on the     effectiveness of an innovative program for improving sanitation in rural areas. They will     learn whether the program has worked or failed to achieve its objective of eradicating open     defecation, and about key factors explaining success and failure.   "
105824|NCT01900899|"     The purpose of this study is to evaluate the long-term antibody persistence as well as safety     of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster     vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039     Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039     (NCT00474266) at 12 through 23 months of age.   "
105825|NCT01900886|"     Primary objective: Evaluate the prevalence of personality disorders in patients starting     treatment for hepatitis C in the prison and determine their influence on the evolution of the     disease.   "
105826|NCT01900873|"     Patients with chronic obstructive pulmonary disease are often limited in their exercise     capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung     volumes during exercise which forces inspiratory muscles to work at a high percentage of     their maximal capacity. This increased inspiratory effort has been shown to be independently     related to symptoms of dyspnea during exercise in previous research. Eight weeks of high     intensity variable flow resistive inspiratory muscle training is hypothesized to reduce     inspiratory effort and to decrease neural drive to inspiratory muscles. These factors are     hypothesized to jointly contribute to delaying the occurrence of intolerable symptoms of     dyspnea and to improve exercise tolerance in these patients.   "
105827|NCT01900860|"     We propose to conduct a randomized double blind trial of three doses of vitamin D, 400, 4000,     and 10,000 International Units (IU) per day, to assess the effect on bone density and     architecture as assessed by high resolution peripheral quantitative tomography (HR-pQCT)     measurements at the radius and distal tibia, and standard Dual X-ray absorptiometry (DXA).     Other measures of bone and calcium metabolism will be assessed. The trial will last as long     as three years. Approximately 300 healthy men and women, aged 50-70 years of age, will be     recruited, and randomly assigned to one of the three doses of vitamin D. Other outcome     variables assessed include quality of life, depression, muscle strength and balance.   "
105828|NCT01900847|"     Our goal is to study whether giving people low dose ketamine along with morphine when they     come to the Emergency Department will help their pain more than giving morphine by itself.     There have been many studies showing that low dose ketamine is safe and effective for pain     control. Ketamine is frequently used for pain control in ambulances and helicopters     transporting injured patients to the hospital and has also been used for pain control in     people who have just had surgery. The investigators would like to see if low dose ketamine     would be safe and effective for patients with pain in the Emergency Department.      Patients are eligible for the study if they come to the Emergency Department and their     treating physician decides to treat them with morphine (with certain exceptions such as     pregnant patients and patients with eye injuries). They will be given information about     participating in the study and if they agree, they will be given the study drug. The study     drug will be either ketamine or salt water (saline). If patients continue to be in pain they     will continue to receive doses of morphine just as they would if they were not in the study.     If the treating physician feels that morphine alone is not enough, they will be free to     choose another pain medication as they would normally.   "
105830|NCT01900821|"     The National Mammography Database (NMD) leverages data that radiology practices are already     collecting under federal mandate by providing them with comparative information for national     and regional benchmarking. Participants receive semi-annual feedback reports that include     important benchmark data such as cancer detection rates, positive predictive value rates and     recall rates. Participation in the NMD is free to Breast Imaging Center of Excellence (BICOE)     facilities.   "
105831|NCT01900808|"     Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but     fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%.     The aim of this study is to evaluate the applicability and diagnostic accuracy of TE     performed by trained operators (<500 explorations), after a second evaluation by experienced     explorers (>500 explorations) and after a third exploration using XL probe. Inadequate LSM     will be re-evaluated by experienced operators with the M (standard size) probe. A third     register will be performed with XL (obese size) probe in those patients with inadequate M     probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to     identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).   "
105832|NCT01900795|"     The primary objective of this study is to assess the analgesic properties of an oral dose of     V117957 4.5 mg aqueous suspension in the third molar extraction model   "
105833|NCT01900782|"     This withdrawn study was to assess the safety and efficacy of secukinumab compared to     etanercept and placebo in patients who have moderate to severe, chronic, plaque-type     psoriasis.   "
106099|NCT01897298|"     This project plans on a training intervention by using public spaces and urban walkable     trails, adapted to each patient needs and capabilities. Primary objective is to assess 12     months effectiveness of the intervention with respect to: (primary outcome): physical     activity level, and (secondary outcomes): COPD admissions, exercise capacity, body     composition, quality of life, and mental health.   "
105834|NCT01900769|"     Although blood volume is such an important parameter in everyday clinical medicine it cannot     be measured easily. As a matter of fact, it is almost never measured but estimated or     calculated based upon numbers derived from mostly healthy patients.      The investigators do not even know whether someone's normal - i.e. before a surgery - blood     volume is actually anywhere close to the generally accepted estimate or calculation.      Tests exist in which a substance of known concentration is diluted in a person's blood volume     and the resulting concentration is then measured, which allows the blood volume to be     calculated. However, none of these tests can be completed at the bedside since they are not     fast and require considerable set-up.      This study turns the above approach upside-down: we will dilute the blood slightly with a     known small volume of an intravenous fluid commonly used in many clinical settings and     measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells -     before and after adding the fluid. That allows for similar calculations without using neither     specialized substances nor equipment.      Hemoglobin is routinely measured in laboratories and is often a routine test before and     during surg-eries and in intensive care units.      Devices that can measure hemoglobin through the skin without actually drawing any blood are     avail-able. If found comparable to laboratory determination of hemoglobin they could provide     for a bedside and almost real-time assessment of blood volume, something that could be     extremely valuable for de-cision making in critical areas of medicine and promoting goal     directed therapies.   "
105835|NCT01900756|"     The purpose of this study is to determine whether a culturally-sensitive multipronged     post-discharge intervention can significantly reduce blood pressure, enhance achievement of     guideline recommended targets for risk factor control, and lower recurrent vascular events in     a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase     (Phase 1) lasting less than one year involving development of the intervention through focus     group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3     years involving a randomized trial testing the efficacy of the intervention.   "
105836|NCT01900743|"     This is an international (France, Austria and Germany), randomized, double-blind,     placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in     patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS)     after failure or intolerance to doxorubicin (or other anthracycline).      Five cohorts will be defined:      Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other     sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas     listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet     the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment     groups.   "
105837|NCT01900730|"     The goal of this clinical research study is to learn if receiving valproic acid (VPA)     compared to a placebo can reduce the amount of time you will need to have an indwelling     pleural catheter compared to the standard of care, which involves using an indwelling pleural     catheter alone.      VPA is designed to stop cancer cells from dividing and maturing. This may cause the cancer     cells to become less malignant and cause less pleural fluid production.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
105838|NCT01900717|"     To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly     patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm     with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years     and older.      This study is destined to continue as a phase III trial if both arms meet the selection     criteria to show or not the benefits of treatment with bevacizumab combined with     chemotherapy.   "
105839|NCT01900704|"     To investigate the efficacy and safety of SER120 nasal spray formulations in patients with     nocturia   "
105840|NCT01900691|"     The CLARITY study is a clinical trial approved by US FDA to study the removal of the     Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.   "
105841|NCT01900678|"     The objective of this investigation is to evaluate whether pulmonary vein isolation using the     VytronUS ablation system is safe and effective acutely and at 3 months.   "
105842|NCT01900665|"     To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD)     as compared with placebo in participants with mild AD.   "
105843|NCT01900652|"     The primary purpose of this study is to evaluate the efficacy of the study drug known as     LY2875358, administered alone or in combination with a second drug named Erlotinib, in     participants affected by a defined type of lung cancer (MET biomarker diagnostic positive     Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent     treatment with Erlotinib.   "
105844|NCT01900639|"     Low-dose aspirin is a cornerstone in the secondary prevention of cardiovascular disease (CVD)     and is usually taken on awakening, although evidence regarding optimal time of intake is     lacking. Platelet reactivity follows a circadian rhythm, with a peak in the morning,     contributing to the morning peak of cardiovascular disease. Due to its short half life,     aspirin only inhibits platelets which are present at the time of intake. Thus, the timing of     aspirin intake may influence its inhibitory effect on platelets and intake of aspirin at     bedtime may attenuate the morning peak of platelet reactivity. The time-dependent effect of     aspirin on circadian rhythm of platelet function has never been studied before. We     hypothesize that aspirin intake at bedtime compared with intake on awakening results in a     reduction of the morning peak in platelet reactivity.   "
105845|NCT01900626|"     This is a study comparing pain control utlilizing one or two epidural catheters, along with a     hydromorphone PCA, for analgesia following surgery for correction of scoliosis.   "
105890|NCT01900028|"     This is a 3-part study in patients with advanced solid tumours: Part A will assess the effect     of itraconazole on the PK parameters of olaparib and will determine the effect of olaparib on     the QT interval following single oral dosing; Part B will determine the effect of olaparib on     the QT Interval following multiple oral dosing; Part C will allow patients continued access     to olaparib after the PK and QT phases and will provide for additional safety data     collection. A total of 48 patients are planned to be enrolled; at least 42 evaluable patients     will be required to complete the study. Patients will participate as a single cohort in all     parts of the study.   "
105846|NCT01900613|"     Obesity and overweight are health problems resulting from the interaction of predisposing     genes with environmental, economic and social stimuli, in conjunction with excess caloric     intake throughout growth from childhood to adulthood. Evidence suggests that a major barrier     in controlling overweight/obesity is the complex interrelation of these factors, making     single-approach interventions less likely to succeed than integrated, multi-faceted     approaches. The proposed project aims to deliver a multi-faceted behavioral intervention     developed over the past 18 months by a university-community /school-based collaborative. This     project aims to provide new knowledge about the effectiveness of interventions designed     specifically to achieve successful weight management among Mexican-origin children ages 3-8,     and identify associated mediating factors. Deliverables will include community-based,     collaborative and sustainable tools to support weight-management goals in this demographic.     UC Davis and UC Cooperative Extension (UCCE) faculty form the investigator team,     collaborating on key decision points with the project community in California's Central     Valley. The investigators hypothesize that the identified mediating factors will increase     fruit and vegetable consumption. The investigators also hypothesize an increase in the     intensity and frequency of physical activity among children in the intervention group.   "
105847|NCT01900600|"     The proposed study is a sub-study of the CANTOS trial (A randomized, double-blind,     placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the     prevention of recurrent cardiovascular events among stable post-myocardial infarction     patients with elevated high sensitivity C-reaction protein (hsCRP) [CACZ885M2301]).      The study proposes to perform serial Cardiopulmonary Exercise Tests (CPX) to prospectively     measure changes in aerobic exercise capacity in patients with prior myocardial infarction     (MI), elevated C reactive protein plasma levels, and symptomatic heart failure with reduced     systolic function, who are enrolled in the main CANTOS trial and are randomly assigned to     Canakinumab (3 different doses) or Placebo.      The subjects enrolled in this substudy will undergo repeated CPX and echocardiograms over the     first 12 months of the CANTOS trial. The subjects will received the experimental treatment as     randomized in the main CANTOS trial and they will not receive any additional experimental     treatment as part of the sub-study.      This study is a an Investigator-initiated (Dr. Abbate) single-center (Virginia Commonwealth     University) sub-study of the CANTOS trial, supported by Novartis pharmaceuticals.   "
105848|NCT01900587|"     The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER)     tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release     formulation 2 (PR2) tablet, in healthy participants.   "
105849|NCT01900574|"     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the     study medication) and safety of subcutaneously (under the skin) administered golimumab in     pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative     Colitis (UC).   "
105850|NCT01900561|"     This study will provide much needed information about how to optimize the quality of care and     quality of life of Veterans who are survivors of prostate cancer.   "
105851|NCT01900548|"     The aim of this study is to investigate potential metabolic effects of whey protein high in     protein and high in leucine(HPHL) compared to soy protein high in protein and low in     leucine(HPLL) in osteopenic patients in a randomized controlled intervention study.      The investigator hypothesize that HPHL will increase physical function and the ratio muscle     mass / fat mass in this condition.   "
105852|NCT01900535|"     The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison     with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.   "
105853|NCT01900522|"     The purpose of this study is to characterize the safety and tolerability profile of ITI-214     when administered as multiple doses of oral solution at escalating dose levels.   "
105854|NCT01900509|"     Participants with relapsed or refractory leukemia or lymphoma will be recruited for this     study to find whether or not the addition of a new drug called bendamustine will be safe and     possible to give with other chemotherapy drugs. This drug is approved by the Food and Drug     Administration (FDA) for the treatment of other cancers in adults that are similar to those     being studied in the research trial.      PRIMARY OBJECTIVES        -  To establish the maximum tolerated dose (MTD) of bendamustine in combination with          clofarabine and etoposide in pediatric participants with hematologic malignancies.        -  To characterize the safety profile and dose-limiting toxicities (DLTs) of bendamustine          in combination with clofarabine and etoposide.      SECONDARY OBJECTIVES        -  To estimate event-free survival at 4 months.        -  To estimate minimal residual disease (MRD) levels present at end of each cycle of          therapy in participants with leukemia.        -  To characterize the pharmacokinetic profile of bendamustine in the proposed regimen.   "
105855|NCT01900496|"     This research is being done to study a combination of Brentuximab vedotin and Rituximab for     the treatment of relapsed Hodgkin's Lymphoma (HL).   "
105856|NCT01900483|"     The project will specifically focus on the examination of the influence of substantial weight     loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight     loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and     inhibitory networks in diabetic subjects. Therefore the investigators will conduct a     functional magnetic resonance imaging (fMRI) study investigating functional measures.   "
105857|NCT01900470|"     The purpose of this proposal is to compare the effectiveness of community health worker (CHW)     support vs. usual primary care for helping chronically-ill, low-SES patients to improve     control of chronic conditions. Upon enrollment each patient will select one of their multiple     chronic conditions as a focus for the trial and work with his/her PCP to set a chronic     disease management goal. Patients are then randomized to receive usual primary care vs. CHW     support for moving towards that goal.   "
105901|NCT01899885|"     The objective of this study is to implement an optimized perioperative course for patients     undergoing acute high-risk abdominal surgery in order to improve the outcome.      The optimized perioperative course consists of a number of interventions carried out before,     during and after surgery.   "
106140|NCT01896739|"     To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular     Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous     administrations of DTaP and HB vaccine each administered to healthy infants, as measured by     seroprotection/vaccine response rates 4-8 weeks post-final immunisation.   "
105858|NCT01900457|"     The present project aims at describing how vestibular signals contribute to the multisensory     mechanisms of bodily self-consciousness.      There is a large body of data regarding the sensory and neural mechanisms of     self-consciousness, but most studies have so far demonstrated the contribution of visual,     tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have     neglected the contribution of the vestibular system, a major sensory system for spatial and     bodily representations. The vestibular system is sensitive to head motions in space and head     inclinations with respect to gravity and it should therefore contribute significantly to     several bodily experiences. This contribution should be put under neuroscientific scrutiny.     We believe that the current neuroscientific models of bodily self-consciousness will be     incomplete until they incorporate the contribution of vestibular signals.      The present project specifically aims at testing the hypothesis according to which vestibular     signals significantly influence bodily self-consciousness, in particular first-person and     third-person perspective taking and the internal body models (i.e. the body schema and body     image). The present project also aims at describing how cortical vestibular processing is     modified during experimental changes of perspective taking and viewpoint. In addition, the     present project will describe whether vestibular disorders change performances in     third-person perspective taking tasks and modify internal body models. This should help     understanding bodily symptoms in vestibular-defective patients. To this end, we will combine     approaches from psychophysics and electrophysiology (electromyography,     electroencephalography) in healthy volunteers and behavioral approached in patients with     vestibular disorders.      These studies should further the understanding of how the brain processes vestibular signals,     which is to date poorly understood. In addition, the outcome of the present project should     help understanding the multiple and complex symptoms reported by patients with vestibular     diseases, and should therefore improve their treatment.   "
105859|NCT01900444|"     The aim of this study is to document the immunogenicity and safety of a booster dose of     IMOJEV® administered 12 months after the primary dose.      Primary objective:        -  To describe the immune response to Japanese Encephalitis (JE) before (Day 0) and 28 days          (Day 28) after a booster dose of IMOJEV® administered at least 1 year after primary          vaccination with IMOJEV®.      Exploratory objectives:        -  To test the non-inferiority of IMOJEV® versus previous data obtained in the JEC15 study          (NCT01190228) with the same product in terms of seroprotection rate 28 days after          booster vaccination.        -  To describe the safety profile of a booster dose of IMOJEV® .   "
105860|NCT01900431|"     Primary Objective:      To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis     (NIU).      Secondary Objectives:      To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of     subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To     evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal     vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant     therapy.      To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the     pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with     anti-drug antibodies (ADA).   "
105861|NCT01900418|"     For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors,     aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong     disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness     (arthralgia) is a common side-effect of AIs. This proof-of-concept study explores how an     evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease     (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them     maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness,     and 3) thereby enable them to remain on AI therapy as prescribed.   "
105862|NCT01900405|"     This study has the objective to determine if intranasal dexmedetomidine, a sedative, is     suitable for pediatric sedation in children undergoing tomographic scans.   "
105863|NCT01900392|"     This study aims to evaluate the effectiveness of financial incentives in improving and     maintaining weight loss.   "
105864|NCT01900379|"     The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome     (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG)     surgery or other coronary reperfusion.   "
105865|NCT01900366|"     This study will test the potential of two techniques using light properties of adipose tissue     to diagnose crown-like structures and inflammation to be compared with pathologic examination     of adipose tissue biopsies from ongoing clinical studies.   "
105866|NCT01900353|"     The aim of this randomized, single-blind, split-mouth design, clinical trial was to evaluate     the effectiveness in plaque removal of the vertical and the horizontal brushing methods.     Trauma on soft tissues were also registered. Sixty-one (61) young adults were enrolled for     this trial and forty-three (43) completed the brushing session. All subject were asked to     abstain from oral hygiene procedures for 48 hours before the brushing session to allow     adequate plaque accumulation. They were firstly instructed to use a dental disclosing tablet     in order to easily permit to detect dental plaque on teeth and to highlight soft tissue     abrasions. Plaque and the abrasion indexes were recorded according to the Rustogi Modified     Navy Plaque Index (RMNPI) and the Danser Index (DI) by the same examiner. The brushing     session was always performed by the same dental hygienist who brush with a randomized     split-mouth design. After the brushing session, the blinded examiner recorded the indexes     again.   "
105867|NCT01900340|"     The aim is to further establish a physiological role for GLP-1 as an endogenous satiety     signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on     appetite and food intake in healthy male subjects.   "
105868|NCT01900327|"     Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary     Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma   "
105869|NCT01900314|"     The purpose of this research is to learn more about how rTMS works to reduce the symptoms of     depression. This information can be used to improve the effectiveness of the treatment. The     study will use functional magnetic resonance imaging (fMRI) to examine changes in brain     function after treatment with rTMS. fMRI is a safe and painless technique that allows     investigators to observe the brain at work. The investigators will use fMRI to see what     regions of the brain become active when you perform a concentration task and how that     activation is changed after rTMS.   "
105888|NCT01900054|"     The objective of this study is to evaluate the long-term safety and efficacy of TAU-284     (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks     administration.   "
105902|NCT01899872|"     The aim of this study is to evaluate the effect of a single session of aerobic plus     resistance exercises on the vascular function of patients with type 1 diabetes mellitus. The     investigators hypothesize that a single aerobic exercise session would promote greater     benefit in vascular function of patients with type 1 diabetes, as compared with the resistive     exercise session.   "
112255|NCT01816607|"     The purpose of this study is to establish a reliable method for detection of rectal cancer     patients with aggressive tumor at risk of metastatic disease and death by functional MRI.   "
105870|NCT01900301|"     Fear, whether it occurs in humans suffering from an anxiety disorder or in experimental     models with rodents, is reduced by exposing the frightened organism to the fearful stimulus     in the absence of any negative consequences (i.e., extinction, or exposure therapy). However,     fear often renews when the feared stimulus is encountered in a context different from the     exposure context. In rats, the investigators found that interfering with the animal's ability     to process contexts during extinction by administering an anticholinergic drug prevented fear     renewal. This proposal will determine if the beneficial effect of this drug translates to     exposure therapy in socially anxious humans. To this end, 100 individuals with Social Phobia     who fear public speaking will undergo repeated sessions of exposure to public speaking,     within a virtual reality context. Participants will be randomized to either drug placebo,     .2mg/.01 mL Scopolamine, .3mg/.01 mL Scopolamine or .4mg/.01 mL Scopolamine, administered via     nasal drops, prior to each session of exposure therapy. One month after completion of     exposure therapy, context renewal will be tested by comparing physiological and subjective     responses to public speaking in the same virtual context as used during exposure therapy     versus a context different than the one used during exposure therapy. The goal is to identify     the dose of Scopolamine associated with the greatest reduction in context renewal. In     addition, a secondary analysis will attempt to identify those individuals who benefit most     from Scopolamine-augmentation of exposure therapy.   "
105871|NCT01900288|"     The purpose of this study is to test Mobile Technologies in Assisting Patients & Family     Caregivers in Healthy Living and complex home care by connecting to information and     professionals from a distance.   "
105872|NCT01900275|"     Across the world, the most common cause of dying in the ICU is a disease called sepsis.     Sepsis is a disease in which the body's protective response to infection becomes too intense,     unnecessarily damaging important organs in the body. Kidney damage during sepsis is     particularly bad, as a person's chance of survival drops significantly when he or she     develops kidney failure. This study plans to learn more about how to detect (and thus     prevent) kidney failure early in sepsis. The current tests doctors use only detect kidney     failure once it's already happened. We must therefore find better ways of detecting kidney     failure earlier, when there is still a chance to protect the kidneys.      In this study, patients will provide a one-time sample of urine. We will check this urine for     signs of a protein called heparanase, which we believe is important in early kidney     failure. We will then see if high heparanase activity in urine predicts the risk of     developing kidney failure. We will compare results from patients with sepsis with results     from patients with trauma, allowing us to determine if heparanase is only important in sepsis     kidney failure.   "
105873|NCT01900262|"     The purpose of this study is to understand the effects of muscle strengthening and balance     exercise interventions on muscle strength, running mechanics and postural control in novice     recreational runners. Participants will be assessed before and after they engage in an 8-week     exercise intervention program.   "
105874|NCT01900249|"     The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are     safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.   "
105875|NCT01900236|"     iENGAGE is a 4 session, in-clinic behavioral intervention that is delivered to new clinic     patients during the first year of HIV care on a flexible delivery schedule, with intervention     visits scheduled to coincide with HIV medical care visits. Interventionists from each     participating collaborating site will be trained centrally to implement the iENGAGE protocol.     Following study enrollment and baseline assessment, participants will be randomized to     treatment as usual and intervention groups. For intervention-arm participants, each iENGAGE     intervention session includes: interventionist-delivered educational content for managing HIV     medical care appointment-keeping and information sessions for learning to manage HIV     medications. The intervention will have a tailored, interactive agenda for each of the 4     sessions based on behavioral motivational interviewing (MI) techniques. The goal of this     intervention is for the participant to establish early behaviors that help him/her to arrive     at scheduled medical appointments and learn to take medications as prescribed during the     initial year of HIV care in order to improve overall health.   "
105876|NCT01900223|"     Chronic pain is relatively common after different types of surgery. The investigators intend     to study prevalence, characteristics and risk factors of chronic pain after shoulder     arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as     preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.   "
105877|NCT01900210|"     The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR) Project is     to develop and test an intervention designed to increase positive decision-making skills     among offenders for healthy living, including skills for making decisions for reducing     disease risk behaviors, particularly those involving HIV and Hepatitis B & C. This project     focuses on the critical transition time between incarceration and return to the community.   "
105878|NCT01900197|"     The purpose of this study is to monitor and quality assure the efficacy and safety of     Monofer® in a broad patient population when Monofer® is used according to the Monofer® label     (SPC) in current practice and where standard routines are being followed.   "
105879|NCT01900184|"     1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending     single/multiple oral doses (SAD & MAD) in healthy young subjects, the preliminary food     interaction and the effect of QGC001 on blood pressure and heart rate, but also to determine     pharmacokinetic preliminary profiles of QGC001 and its metabolite EC33 and pharmacodynamic     preliminary profiles of QGC001 and its metabolite EC33 especially effects on the     renin-angiotensin-aldosterone and copeptin systems.   "
105880|NCT01900171|"     QGC001/1QG1 is a Phase I first time in man study aiming to determine the overall safety and     tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to     placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the     pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system,     blood pressure and heart rate) in healthy male subjects.   "
105881|NCT01900158|"     This is a Phase I/II Dose Escalation Study in which the safety, tolerability and efficacy of     Amphinex-induced Photochemical Internalisation (PCI) of Gemcitabine followed by     Gemcitabine/Cisplatin Chemotherapy will be assessed in patients With advanced inoperable     cholangiocarcinomas.   "
105882|NCT01900132|"     Background:      - Electrical impedance myography (EIM) is a new technique being studied to see if it is     helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild, painless     electrical current travels through muscles. Researchers want to gain experience in using the     EIM device. They will collect information on the results of using it on people with and     without nerve and muscle diseases, and compare that with information from other standard     tests. First, they will test the device on healthy people. Then they will test people with a     variety of neuromuscular diseases. Because the test is noninvasive and not painful,     researchers will test both children and adults.      Objectives:      - To gain experience using the EIM muscle testing device.      Eligibility:        -  Healthy volunteers at least 2 years old.        -  Individuals at least 2 years old who have neuromuscular disease.      Design:        -  Participants will be screened with a medical history and physical exam.        -  Participants will have one 2 3 hour clinic visit. Researchers may request follow-up          visits.        -  Participants will be tested with the EIM device. The device and small electrodes will be          placed on their skin. An electric current will pass through the device, but the          participants will not feel this.        -  Participants may have an ultrasound test. A gel will be put on their skin, and a device          will be moved over the skin.        -  Participants may have a nerve test. Electrodes will be placed on their skin, and they          will feel a small shock.        -  Participants may have a test where a thin needle is inserted in their muscle.   "
105883|NCT01900119|"     Background:      - This research is being done to describe the types of bacteria found in the mouths of     patients who have severe aplastic anemia (SAA) and are treated with drugs that suppress the     immune system or with stem cell transplant. People with SAA who receive these treatments are     more likely to get infections. Studies show that there might be a link between the bacteria     in your mouth and those bacteria that can cause infections. The bacteria found in the mouths     of patients with SAA will be described.      Objectives:      - To understand the changes in mouth bacteria that are related to treatment and to describe     the oral bacterial environment.      Eligibility:        -  Adults at least 18 years of age who are going to be treated for SAA.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants will answer questions about their medical history and dental care. Their          mouths will be examined.        -  Participants with SAA will be tested during treatment for their disease, over the course          of 1 year. All participants with SAA will be tested at 3 scheduled appointments. Any          participants who require a breathing tube will receive additional tests.        -  Healthy volunteers will be tested during 1 visit.        -  Participants will give two samples each time. A saliva sample will be taken with a          disposable padded tool. Skin cells will be collected from the tongue with a small          plastic brush.   "
105884|NCT01900106|"     1. PROTOCOL SUMMARY This is a prospective, randomized open-label, 2 arm, 3-phase trial to     compare the 48-weeks virological response of two different regimens containing     abacavir/lamivudine (abacavir/lamivudine +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine     + raltegravir (RAL) in antiretroviral therapy naive, HIV+ individuals presenting for care     with CD4+ counts < 200/mm3.      1.1 Clinical Objectives: Primary Objective: To compare the 48-week virological response to     two different regimens containing abacavir/lamivudine (abacavir/lamivudine     +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine + raltegravir (RAL) in antiretroviral     therapy naive, HIV+ individuals presenting for care with CD4+ counts < 200/mm3.      Secondary Objective: a) To compare immunological response at 48 weeks; b) To determine the     safety and tolerability of the 2 regimens.      1.2 Study population: 350 in/out patients 1.3 Outcome Primary Endpoint        -  Proportion of patients with HIV RNA<50 copies/mL after 48 weeks Secondary Endpoints(s)        -  Change in CD4+ cell count from baseline through week 48        -  Time to virological rebound 1.4 Study design: Multicentre, parallel group, randomised,          open label, non-inferiority study 1.5 Treatment regimens: Arm A: abacavir/lamivudine 1          tablet once a day + raltegravir 400 mg (1 tablet twice a day) Arm B: abacavir/lamivudine          1 tablet once a day + ritonavir 100 mg + darunavir 800 mg once a day.      All drugs have been approved for the treatment of HIV infection. The study population will     consist of 350 HIV-positive, HLA B5701-negative patients. At baseline, patients will be     randomized 1:1 to start abacavir/lamivudine plus either raltegravir or darunavir/ritonavir.     Randomization will be stratified on the basis of the screening CD4+ cell count (≤100 vs ≥100     cells/µL), to ensure balance across treatments groups 1.7 Criteria for Safety: Adverse events     and laboratory assessments. 1.8 Statistical analysis: As this is a non-inferiority trial, we     will calculate the difference in the proportions of patients experiencing the primary outcome     in the two treatment arms and will calculate a 95% confidence interval for this.     Non-inferiority of the raltegravir arm will be demonstrated if the lower limit of the 95%     confidence interval is greater than -12%. In case non-inferiority will be met, analyses for     superiority will be performed.   "
105885|NCT01900093|"     Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not     widely used. Thus, we propose to conduct a small open-label proof-of-concept trial to     evaluate the response to ACTHAR gel therapy in patients who have failed to make a     satisfactory recovery after treatment with high dose IVMP. Documentation of the clinical     course as well as any adverse events related to IVMP use will be made. The investigators     propose to study the potential benefit of a 14-day course (the dose historically used since     the landmark clinical trial of Rose et al1) of subcutaneous ACTHAR gel in 10 patients who     have demonstrated inadequate improvement after a course of IVMP, 1000 mg daily, for 5     treatments (over a maximum of 8 days). These would be patients for whom PLEX would be     considered as a treatment possibility. The primary outcome measure will be improvement in the     targeted neurological deficit, as measured on the appropriate functional system score (FSS)     of the EDSS.   "
105886|NCT01900080|"     The purpose of this study is to determine if same-day HIV testing and antiretroviral therapy     (ART) initiation improves retention in care (as measured by the proportion of participants     who are alive and in-care with an undetectable viral load 12 months after HIV testing),     compared with standard of care (three visits prior to ART initiation). Secondary outcomes     include survival, ART initiation, retention in care with viral load < 200 and < 1000     copies/ml, 6-month viral load, and adherence as measured by self-report and pharmacy refill     records. Enrollment for the main study was completed in October 2015.      In June 2015, enrollment was started for a new sub-study. This sub-study, funded by MAC AIDS,     includes patients with WHO stage 1 or 2 disease and CD4 count >500 cells/mm3. The purpose of     the sub-study is to compare 6-month retention for patients who receive same-day ART vs.     standard pre-ART care. Secondary outcomes include adherence to INH and Bactrim, and     cost-effectiveness between the two groups. Enrollment for the sub-study is ongoing.   "
105887|NCT01900067|"     The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled     Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active     Self-Warming Blanket Used for Continuous Active Warming to Prevent General Anaesthesia     Induced Hypothermia During the Perioperative Surgical Period. Null hypothesis (H0): There is     no difference between the two study populations (interventional treatment group versus     control treatment group) regarding the average of core body temperature measurements during     the perioperative phase.Alternative hypothesis (H1): The average of core body temperature     measurements during the perioperative phase is significantly higher in the interventional     group compared to that of the control group.   "
105891|NCT01900015|"     Primary Objective:      To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to     rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen     on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among     HIV/HCV-coinfected patient.      Secondary Trial Objective:        1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in          the grade of HS between patients continuing with EFV plus two nucleoside analogs and          those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.        2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50          copies/mL) after switching.      Design:      Open-label, randomized clinical trial to evaluate safety (phase IV)      Condition:      HIV and HCV coinfection.      Intervention:      Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV     to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current     regimen.   "
105892|NCT01900002|"     The goal of this clinical research study is to learn about the safety of combining sorafenib     with TheraSphere in the treatment of patients with advanced liver cancer.   "
105893|NCT01899989|"     The purpose of this study is to determine if the use of exploratory immunologic biomarkers,     functional MRI images can serve as early predictors for response of NSCLC. It also will     provide important information on the perceived side effects from a patient perspective.     Patients may participate if they have tumors ≥3 cm without lymph node involvement (for which     chemotherapy is not part of the standard of care). Patients will only receive stereotactic     body radiation therapy (SBRT) per standard dose guidelines.   "
105894|NCT01899976|"     The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered     Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The     study is designed to support the regulatory requirement of a 510(k) marketing application in     the United States.   "
105895|NCT01899963|"     In this province, optometrists are often responsible for contacting the retinal specialists'     office to arrange patients to be examined for suspected emergencies or more routine referrals     related to the eye. This is often done by faxing a referral form to the specialists' office,     where the retinal specialist will examine the information presented in the referral form and     make a decision on when the patient should be seen. This current method has some important     considerations, such as the difficulty of transmitting clear images of the back of the eye     over fax. Having this information could help the retinal specialist in determining when the     patient should be seen, especially in terms of booking additional tests or when treatment     should be given.      Teleophthalmology is a branch of telemedicine that delivers eye care through digital     equipment and telecommunications technology. It offers some unique advantages, such as the     ability to be integrated with electronic health records, the ability to be viewed by multiple     members of the health care team, and potentially reduce wait times and travel times to the     ophthalmologist.      However, there is no comparison known to the study team between whether patients being     referred from optometrists to retina specialists through a teleophthalmology system will be     treated earlier than patients through a conventional fax system. This study aims to examine     and provide more information on this topic.   "
105896|NCT01899950|"     Niemann-Pick Disease, Type C (NPC) is a rare neurodegenerative disorder with a wide clinical     spectrum and variable age of onset. Classically, children with NPC demonstrate neurological     dysfunction with cerebellar ataxia (an inability to coordinate balance, gait, extremity and     eye movements), dysarthria (difficulty speaking), seizures, vertical gaze palsy (ability to     move eyes in the same direction) motor impairment, dysphagia (trouble swallowing), psychotic     episodes, and progressive dementia. There is no curative treatment for NPC and it is a lethal     disorder. The purpose of this protocol is to obtain both baseline and rate of progression     data on a clinical and biochemical markers that may later be used as outcome measures in a     clinical trial. Specifically, this study will examine and characterize the longitudinal     progression of neurocognitive symptoms of NPC with the goal of identifying early markers of     disease progression that may be utilized in later trials to evaluate treatment efficacy.   "
105897|NCT01899937|"     Flow mediated dilation (FMD) of the brachial artery has been widely used as a non-invasive     measure of endothelial function. FMD independently predicts future cardiovascular events and     can be readily influenced by pharmacological, dietary or lifestyle interventions. However,     the interpretation of FMD data is currently importantly hampered by differences in     measurement methodologies and analysis techniques between laboratories. These differences     result in large variation of 'normal' values between laboratories, highlighting the need for     adopting widely supported and evidence-based guidelines.   "
105898|NCT01899924|"     The main objective of this study is to describe differential cognitive processing of various     stimuli by a population of control subjects and a population of patients with selective     cognitive deficits or altered states of consciousness by using dedicated ERP paradigms and     high-density EEG picked up system.   "
105899|NCT01899911|"     A clinical study designed to determine the accuracy of the peripheral capillary oxygen     saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood     saturation level.   "
107703|NCT01876680|"     The purpose of this study is to investigate the effects of specific neck/shoulder muscle     exercises on pain, function, biochemistry and psychological factors in women suffering     chronic neck/shoulder pain.   "
105900|NCT01899898|"     One third of children with epilepsy have seizures that are medically intractable.     Uncontrolled seizures pose a variety of risks to children, including higher rates of     mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible     option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins     diet have been shown to be effective alternative treatments in children with refractory     epilepsy. However, these need parents to be educated, and understand complex instructions of     weighing foods and diet preparation. Therefore, children with parents with low levels of     literacy and poor socioeconomic status have not been able to benefit from these therapies.     Also, the paucity of trained dieticians and limited availability of labeled foods in     resource-constraint settings has made these dietary therapies even more inaccessible.      This study aimed to to develop a simple-to-administer variation of the modified Atkins diet     for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of     this simplified modified Atkins diet in children with refractory epilepsy in a randomized     controlled open-label trial.   "
105904|NCT01899846|"     This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in     blood throughout pregnancy      There will be 3 cohorts of subjects      Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same     time each day for one week following their first dose of Makena and will have blood drawn     immediately prior to 2 successive Makena doses during Epoch 1 (24 - 28 weeks) and Epoch 2 (32     - 36 weeks)      Cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days     after their first dose of Makena. Subjects will have daily blood draws for one week following     a dose of Makena given in Epoch 1 (24 - 28 weeks) and blood drawn immediately prior to 2     successive doses during Epoch 2 (32 - 36 weeks)      Cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days     after their first dose of Makena. Subjects will have blood drawn immediately prior to 2     successive doses in Epoch 1 (24 - 28 weeks) and daily blood draws for one week following a     dose of Makena given during Epoch 2 (32 - 36 weeks)      A maximum of 10 subjects will be monitored on selected days following a completed course of     Makena therapy to determine the terminal elimination phase.   "
105905|NCT01899833|"     This study will compare how well a new radiolabeled imaging agent ECDG compares to the     current testing for coronary artery disease (radiolabeled Sestamibi) during a rest and stress     cardiac test as documented from results of a coronary angiogram (if performed).   "
105906|NCT01899820|"     Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated     malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria     Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for     uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most     rapidly acting of all the current antimalarial drugs and recognition of their potential role     as a component of combination therapy have led to several large trials aimed at assessing     different combinations of existing drugs, and to the specific development of new combination     drugs.      This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination     drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through     molecular genetics and in this process further strengthen capacity in the proposed study     sites as well as improve links between research and control ultimately to influence malaria     treatment policy and practice.      Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess     the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative     drug. The network will determine antimalarial drug efficacy using standardised protocols and     collate clinical responses and adverse events. Molecular markers to artemisinin resistance     will be investigated by molecular sequencing and comparison of parasite profiles in drug     failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1,     MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies     will be captured into a database developed by the network. The latter offers several     advantages including        -  Working towards the standardization of methodologies and common protocols as a way of          comparing data across sites        -  Pulling together datasets and conduct a multi-centre analysis        -  Sharing and coordinating quality assurance mechanisms   "
105907|NCT01899807|"     The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi     craniectomies. The frequency of infections and rupture of skin will be studied, which is a     reoccurring problem with currently used bone graft substitutes in this subject population. In     addition, the quality of life before and after implantation will be evaluated as well as the     bone regeneration around implant.   "
105908|NCT01899794|"     The purpose of this study is to determine in female patients who suffer mixed urinary     incontinence (MUI) the following: 1) the proportion of patients that are cured or improved by     a single modality therapy (drug or surgery alone), cured or improved by a combined therapy     (drug and surgery in any order) or non-responders to any of theses therapies; 2) which of the     combined therapy sequences (surgery first, then followed by oral drug therapy or oral drug     therapy first, then followed by surgery) is the most effective in patients needing combined     therapy.   "
105909|NCT01899781|"     The investigators assume that simple hand lacerations involving flexors or extensors tendons,     do not require prophylactic antibiotic treatment to prevent wound infection.   "
105919|NCT01899651|"     Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add     to information needed to diagnose neurological problems in infants - both preterm and term.     The investigators propose a method to test these technologies in the preterm population to     determine its safety and ease of use. The investigators will test on preterm infants of 30-34     weeks gestation, starting first with the older infants (32-34 weeks) then moving down to the     smaller population (30-32 weeks). In both groups the investigators will start with a short     time period and gradually extend the time as safety is established.      All studies will be conducted at Shands Teaching Hospital at the University of Florida.   "
105920|NCT01899638|"     This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg     and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.   "
105910|NCT01899768|"     This study is designed to evaluate the effect of GSK2339345 relative to placebo on the number     of coughs in patients with Chronic Idiopathic Cough (CIC) administered by an Aqueous Droplet     Inhaler (ADI). The primary aim is to investigate the efficacy of GSK2339345 on reducing     objective cough frequency in CIC patients. The secondary aim of this study is to investigate     the efficacy of GSK2339345 in inhibiting a hypertussive cough response elicited by capsaicin     and citric acid in CIC patients which have a hyperresponsive cough reflex.      Following the screening visit, all eligible subjects will attend the unit for dosing at     Visits 1-7. At Visits 1, 2 and 3 (Part A of the study), subjects will receive two doses of     either GSK2339345 or placebo, 4 hours apart and will undergo 8 hours of cough monitoring. At     Visits 4 and 5 (Part B of the study) and Visits 6 and 7 (Part C of the study), subjects will     be administered a single dose of either GSK2339345 or placebo. Subjects will then undergo     capsaicin (Part B) or citric acid (Part C) tussive challenge and will undergo cough     monitoring for 1 hour post dose.      The maximum study duration will be approximately 11 weeks, including 3 weeks screening and 2     weeks follow-up. Approximately 30 patients will be randomised into the study, such that     approximately 24 patients complete dosing and critical assessments.   "
105911|NCT01899755|"     GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal     antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted     in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of groups of 12     subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will consist of a     group of 9 subjects, all on active treatment (adalimumab).   "
105912|NCT01899742|"     The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg)     once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects     with COPD who have received tiotropium and continue to have symptoms while on tiotropium.   "
105913|NCT01899729|"     IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors     (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be     encountered during infection) and endogenous nucleic acids (as might be released during     tissue damage during autoimmune disease). In vitro and in multiple animal models of     autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In     Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC     injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were     well-tolerated, with mild injection site reactions and no pattern of systemic reactions or     laboratory changes.      The current study represents the first clinical trial of IMO-8400 in patients with active     autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of     activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist     which demonstrated clinical improvement in this patient population.   "
105914|NCT01899716|"     The study aimed to evaluate the use of exercise as a complementary strategy to treat severe     major depression in inpatients.      Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe     depressed inpatients.   "
105915|NCT01899703|"     This will be a randomized, double-blind, placebo-controlled study to assess safety and     tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC)     and symptoms of pruritus. It is a double-blind, crossover study with subjects receiving     placebo or GSK23306772 in random order during two 14-day treatment periods. Additionally, the     study will determine GSK2330672 exposure and interactions with ursodeoxycholic acid (UDCA).     The total duration of subject participation will be 14 weeks for screening (45 days) and the     treatment period. Subjects who are eligible for enrolment will participate in a 2-week     placebo run-in period. Subjects will be randomized in a crossover fashion (Sequence 1 /     Sequence 2) to receive placebo or GSK2330672 treatment during two consecutive 2-week study     periods. Subjects will then participate in a 2-week placebo dosing follow-up period ending in     final follow-up assessments. Study results will be utilized to form a benefit: risk profile     for GSK2330672 in PBC that will determine plans for progression to exploratory efficacy     trials   "
105916|NCT01899690|"     This study is a randomized controlled non-blinded double arm study examining the effect of     routine postoperative oral antibiotic therapy in preventing postoperative surgical site     infections after breast reconstruction. The investigators hypothesize that use of     prophylactic antibiotics after breast reconstruction does not reduce surgical site     infections.   "
105917|NCT01899677|"     The aim of this prospective double blinded randomised study is to investigate the efficacy of     symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum,     Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama     acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory     pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing     enterocolitis pathogenesis in very low birth weight neonates.   "
105918|NCT01899664|"     The goal of the investigators work is to establish how nerve transfers can be best used to     improve upper extremity function in patients with cervical level spinal cord injury (SCI).     The investigators' hypothesis is that nerve transfers are safe and effective and will improve     function and quality of life in patients with loss of upper function due to spinal cord     injury. The investigators plan on looking at upper limb function, and health-related quality     of life in patients before and after surgery to better understand how patients benefit from     these treatments.      A nerve transfer procedure can be used to rewire the system to make some muscles work again     following SCI. The nerve transfer procedure (which is done in the arm and not at the level of     the spinal cord) can be used to bypass the damaged area and to deliver a signal from the     brain to a muscle that became disconnected following that injury. A donor nerve is taken from     another muscle whose use is not essential and then transferred to help in providing more a     more critical function.      For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp     small objects between the fingers that occurs in many patients with cervical SCI. In this     surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the     biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to     the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb     and index finger.      Because the nerve transfer procedure involves cutting and reattaching nerve and muscle     tissues, time is required to regenerate working connections between the nerves and muscle as     well as to allow the brain to relearn how to use and strengthen that muscle.   "
105922|NCT01899612|"     Many postmenopausal women suffer from vaginal symptoms such as dryness, itching, and painful     intercourse. The underlying pathology is unknown. Since symptoms are comparable to those     found in infectious vaginitis during the reproductive life stage, the investigators     hypothesize that the vaginal milieu in symptomatic postmenopausal women is comparable to     inflammation in vaginitis. The investigators therefore study vaginal cytokines in symptomatic     and asymptomatic postmenopausal women.   "
105923|NCT01899599|"     Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced     ovarian, fallopian tube or primary peritoneal cancer.   "
105924|NCT01899586|"     The aim of this study is to devise a sufficiently high intensity training program that     provided an optimal stimulus to remove the peripheral factors known to reduce functional     capacity, and can be cardiovascular and orthopedically well tolerated by the elderly.     Findings from study laboratories have suggested that a regional specific training stimulus     (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel     combination of resistance training and aerobic training applied simultaneously, and in a     serial manner, to specific regions of the body. It involves high-intensity and frequency     muscle contractions, generating a targeted exercise stimulus, without producing excessive     cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at     multiple, strategically selected peripheral sites, in a serial manner will elicit local     vascular and muscular changes, thereby preparing individuals at elevated risk of losing     independence, to respond and progress more favorably to whole-body exercise.   "
105925|NCT01899573|"     The study is designed to demonstrate the safety, feasibility and potential efficacy of using     the AccuCinch® System to reduce functional mitral regurgitation.   "
105926|NCT01899560|"     The recruitment strategy in Acute respiratory distress syndrome (ARDS) patients mechanically     ventilated combines recruitment maneuvers and positive end expiratory pressure (PEEP).     Recruitment maneuvers promote alveolar recruitment leading to increased end-expiratory lung     volume in order to prevent repetitive opening and closing of unstable lung units and reduce     the strain induced by ventilation. In addition, recruitment is effective in improving     oxygenation. Variety of recruitment maneuver have been described, the most commonly used is     the application of sustained continuous positive airway pressure at 40 cmH2O for 40 seconds.     Staircase recruitment maneuver (SRM) is an alternative with good hemodynamic tolerance.     Staircase recruitment maneuver (SRM) involves a progressive increase in positive end     expiratory pressure (PEEP) (up to 40 cmH2O), in pressure control ventilation, in order to     increase end-expiratory lung volume (EELV); then a decreasing PEEP trial is performed. The     positive end expiratory pressure (PEEP) to prevent alveolar collapse depends on ratio between     lung elastance and chest wall elastance. If chest wall elastance is high, the PEEP to obtain     a positive end-expiratory transpulmonary pressure is high. The only way for the time being to     know the transpulmonary pressure and the ratio between lung and chest wall elastance is the     use of esophageal catheter. A non-invasive method for measuring the lung elastance by     measuring volume recruited during a change of pressure (∆PEEP/∆EELV) could be used to avoid     the use of esophageal catheter.   "
105927|NCT01899547|"     The purpose of this study is to evaluate the safety and oncological feasibility of     laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.   "
105928|NCT01899534|"     To compare e-screening versus usual screening on: 1) women's and healthcare providers' views     on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression     and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5)     psychometric properties. We also aim to identify factors associated with feasibility of     e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields     similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk     of disclosure is significantly lower and benefit of disclosure is significantly higher in the     e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and     postpartum depression and anxiety; 5) features of e-screening are significantly associated     with feasibility and acceptability, whereas demographic factors are not; and 6) reliability     and validity indices of ALPHA and EPDS are strongly correlated for both administration modes.   "
105929|NCT01899521|"     This is a randomized, placebo controlled trial of dietary zinc and S-adenosylmethionine     (SAMe) in otherwise healthy alcoholic US Veterans. The primary goal is to determine if either     dietary zinc or S-adenosylmethionine (SAMe) can augment lung immune defenses in alcoholics     and thereby decrease the risk of lung injury and infection.   "
105930|NCT01899508|"     This study is looking at whether virtual reality combined with pain coping skills training     helps reduce pain in people who suffer from OA of the knee. Eligible participants will be     asked to come into the study offices for one visit where they will fill out a couple of     questionnaires, do some low impact performance tasks and be taught pain coping skills while     looking into a 3D virtual reality viewer.   "
105931|NCT01899495|"     Previous studies have demonstrated that single nucleotide polymorphisms (SNPs) of the     sodium-bicarbonate co-transporter gene (SLC4A5) are associated with hypertension. We tested     the hypothesis that SNPs in SLC4A5 are associated with salt sensitivity of blood pressure in     185 whites consuming an isocaloric constant diet with a randomized order of 7 days of low     sodium (Na+) and 7 days of high Na+ intake. Salt sensitivity was defined as a ≥7-mm Hg     increase in mean arterial pressure during a randomized transition between low and high Na+     diet.      A total of 35 polymorphisms in 17 candidate genes were assayed, 25 of which were tested for     association. Association analyses with salt sensitivity revealed 3 variants that associated     with salt sensitivity. Of these, 2 SNPs in SLC4A5 (rs7571842 and rs10177833) demonstrated     highly significant results and large effects sizes, using logistic regression. These 2 SNPs     had P values of 1.0×10−4 and 3.1×10−4 with odds ratios of 0.221 and 0.221 in unadjusted     regression models, respectively, with the G allele at both sites conferring protection. These     SNPs remained significant after adjusting for body mass index and age (P=8.9×10−5 and     2.6×10−4 and odds ratios 0.210 and 0.286, respectively). Furthermore, the association of     these SNPs with salt sensitivity was replicated in a second hypertensive population.     Meta-analysis demonstrated significant associations of both SNPs with salt sensitivity     (rs7571842 [P=1.2×10−5]; rs1017783 [P=1.1×10−4]).      In conclusion, SLC4A5 variants are strongly associated with salt sensitivity of blood     pressure in 2 separate white populations.   "
105932|NCT01899482|"     The purpose of this study is to compare functional status and quality of life of a group of     patients with chronic venous insufficiency treated with manual lymphatic drainage with a     group not treated with manual lymphatic drainage.      Investigators hypothesized that manual lymphatic drainage can improve:        -  quality of life,        -  functional status,        -  calf muscle strength,        -  ankle range of motion,        -  edema,        -  severity of disease,        -  and symptoms.   "
105933|NCT01899469|"     Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or     Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.      Design: Single-blind experimental prospective study of clinic intervention. Setting:     Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.      Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were     divided into three randomized groups: Back School (group 1), TENS with Back School (group 2),     and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of     treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were     measured, at the beginning and at the end of the treatment and after three and six months.     Anthropometric and physical activity variables were collected.   "
105934|NCT01899456|"     The study is aiming to document the safety and effectiveness of renal denervation in patients     after renal transplantation with hypertension. Catheter-based renal denervation will be     performed using CE marked, percutaneous Symplicity catheter.   "
106141|NCT01896726|"     The main purpose of this study is to find out how the body absorbs and breaks down a common     birth control pill called Microgynon when it is given with the study drug called baricitinib.     Safety and the body's ability to tolerate baricitinib and Microgynon will also be studied.     The study will last approximately 6 weeks for each participant.   "
105935|NCT01899443|"     Primary total knee or total hip replacement surgeries are costly high volume procedures &     outcomes may be affected by surgical & care processes & individual patient characteristics.     The primary hypotheses is that non compliance with recommended practice impacts patient     outcomes (e.g. the likelihood of complications following surgery). The primary aims of the     study are to evaluate the links between processes & outcomes & if possible develop a model     that will improve patient outcomes & reduce unnecessary practice variation whilst considering     costs.   "
105936|NCT01899430|"     The purpose of this study was to determine whether liraglutide is more effective than     metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome     (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide     than in those treated with metformin.   "
105937|NCT01899417|"     The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal®     total knee replacement system versus standard total knee arthroplasty.      This study is designed to illustrate the difference in cost between standard total knee     replacements and the ConforMIS iTotal at a single institution.   "
105938|NCT01899404|"     The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation     with chemotherapy followed by internal radiation, called brachytherapy. Currently,     brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called     T2-weighted (T2W) MRI.      The main purpose of this study is to determine whether the following imaging tests can     visualize the tumor better for planning the brachytherapy treatment:        1. special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced          MRI (DCE-MRI); and        2. an x-ray test called positron emission test (PET) performed with a sugar dye called FDG.          MRI-guided brachytherapy is resource-intensive and not widely available.   "
105939|NCT01899391|"     Right now it is not possible to predict which patients are going to react more to RT. Many     things could affect patient's response to radiation. One of the factors is whether the person     can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some evidence     that a certain protein called Gamma H2AX is involved in DNA damage and repair and this can be     used to predict the sensitivity of individual patients. The investigators will be studying     this protein: Gamma H2AX) in the blood samples of prostate cancer patients exposed to both     computed tomography (CT) scan and RT treatment. This will help us to understand why different     individuals show differences in side effects following RT.   "
105940|NCT01899378|"     Here the investigators propose to preliminarily investigate the safety and effects of     probiotics in infants in Bangladesh through a pilot randomized clinical trial. The     investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have     an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i)     to confirm the safety of administering probiotic strains to infants in low-income countries,     ii) to determine the effects of dosing frequency on colonization and persistence of     probiotics in the GI tract, iii) to measure markers of intestinal and immune function and     microbiota structure.   "
105941|NCT01899365|"     Background :      Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the     6th cause of death. CAP also frequently associates with other disorders responsible for     admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major     pathogen that is commonly involved and frequently leads to severe infection and admission.     Categories at risk for this pathogen have been determined, and can be proposed     anti-pneumococcal vaccination (APV) that efficiently and safely protects from this     microorganism.      In the context of US health services, monocenter pilot experiences have reported improvement     of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New     Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk     were proposed vaccination at ED. To obtain these results, medical students were specifically     trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center     trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when     physicians were alerted for pneumococcal risk by the software they usually utilized at     bedside. However these experiences remain sparse as additional dedicated resources are     required or patients and attending ED physicians can be reluctant to proceed to vaccination     at ED.      Mobile phone and derived communication modalities are current vectors to deliver information     in several fields including education and medicine. Initially used in developing countries,     short-message services (SMS) have improved behaviour of patients in various medical areas. In     France, the investigators have observed that most patients above 50 years of age admitted     after ED visit are equipped with mobile phone and can receive alerts by SMS.      These observations prompt us to propose a multifaceted procedure to improve APV after ED     visit in at-risk patients, combining structured oral interview, written information and SMS     as reminders.      Purpose : The investigators hypothesized that        -  a multifaceted intervention to promote anti-pneumococcal vaccination combining a          structured oral interview, a written information to patient and his/her general          practitioner, and a series of 3 SMS,        -  improves anti-pneumococcal vaccination at 6 months,        -  in at-risk patients (65+ years) visiting the emergency department. In order to answer          this question, the investigators designed an interventional prospective multicenter          randomized study (cluster).   "
105942|NCT01899352|"     Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess     the mortality, quality of life, laryngeal function, procedures, early and late complications     of tracheostomy performed for critically ill patients admitted in intensive care units.   "
105943|NCT01899339|"     Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an     improved right ventricular function 72 hours post treatment.   "
105944|NCT01899326|"     This pilot clinical trial studies how well desipramine hydrochloride and filgrastim works for     stem cell mobilization in patients with multiple myeloma undergoing stem cell transplant.     Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine     hydrochloride, helps stem cells move from the patient's bone marrow to the blood so they can     be collected and stored.   "
105945|NCT01899313|"     This Phase I behavior therapy development study seeks to improve treatment outcomes for     methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy-     (CBT-) based short message service (SMS) text messaging intervention.   "
105946|NCT01899300|"     The purpose of this study is to establish clinical proof of concept of temporary indwell of     the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory     benign esophageal strictures caused by caustic ingestion.   "
105960|NCT01899118|"     Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a     standard treatment of locally advanced rectal adenocarcinomas, which correlates better local     control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody     against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic     effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to     evaluate the efficacy of the combination of Nimotuzumab administered concurrently with     neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further     investigate its side-effect and toxicity.   "
105947|NCT01899287|"     Occupational hand eczema (OHE) is a frequent disease which often takes a chronic course. The     burden of the disease is high in a personal as well as in a socio-economic context. There is     a need for evaluating new strategies to improve the prognosis for OHE patients. The     objectives of the study is to evaluate the effect of group education on sick lave,     health-related quality of life and disease severity among individuals with newly notified     OHE.      The trial population consist of individuals from the Capital Region of Denmark and Region     Zealand with a suspected skin-related industrial injury notified to the Danish National Board     of Industrial Injuries (DNBII). Recruitment is started Juli 2012, and will continue until the     designed number of participants have been included.      All participants will be assessed in a questionnaire at time T=0 with regard to: self     evaluated disease severity, health-related quality of life, skin protective behaviour,     knowledge of skin protection, self-efficacy, work-role function and if active in workforce.     The participants will then be randomised. The intervention group will be invited to     participate in the educative course, and work place visits will be offered. In the     intervention group a telephone hot line will be available for further questions concerning     these topics. The control group will not have access to any of these interventions. Both     intervention group and control group will be contacted every eighth week about number of days     of sick leave/absence from workforce. Both groups are re-assessed using a questionnaire at     T=12 months. There will be a total of 742 included participants.   "
105948|NCT01899274|"     The purpose of the study is to assess whether an electronic self-management tool,     specifically an iPhone application entitled bant, can improve glycemic control in Adolescents     who have Type 1 Diabetes Mellitus (T1DM).   "
105949|NCT01899261|"     This pilot clinical trial studies stereotactic body radiation therapy in treating patients     with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be     able to send x-rays directly to the tumor and cause less damage to normal tissue.   "
105950|NCT01899248|"     The purpose of this study is to assess the effects of inhalation agent on corrected QT     interval duration during liver transplantation.   "
105951|NCT01899235|"     A randomised open-label pilot study to assess the safety and efficacy of treatment with a     drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to     coronary de novo lesions in vessels 2.5 mm - 4.0 mm.   "
105952|NCT01899222|"     Assessment of handheld fundus images in comparison to conventional fundus camera images.   "
105953|NCT01899209|"     Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures     has been introduced to treat patients affected by this disease. The most used are STARR and     ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison     trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two     procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.   "
105954|NCT01899196|"     Protocol date and version RCB Id : 2013-A00547-38      Etude ANRS EP 52 PIECVIH Title of Study: EPICARDIAL ADIPOSE TISSUE AND CORONARY RISK IN     HIV-INFECTED PATIENTS      Short title - PIECVIH study      Sponsor French National Institute for Health and Medical Research - French national agency     for research on AIDS and viral hepatitis (Inserm-ANRS)      Coordinating Investigator Pr Franck BOCCARA Service de Cardiologie, Hôpital St Antoine INSERM     UMRS 938 Paris, UPMC, Institut hospitalo-Universitaire- Institute of Cardiometabolism and     Nutrition (IHU-ICAN) 184, rue du Faubourg Saint-Antoine 75571 PARIS Cedex 12 Tél. : 01 49 28     24 49 - Fax : 01 49 28 26 83 Courriel : franck.boccara@sat.aphp.fr      Participating country: France      Objectives Principal objective To compare the inflammatory profile of the epicardial adipose     tissue (EAT) between people living with and without HIVwho present with coronary heart     disease and will undergo a coronary artery bypass graft (CABG)      Secondary objectives        -  To compare the volume of EAT between people living with and without HIV who present with          coronary heart disease        -  To evaluate the relationship between the abnormalities of the expression profiles of the          adipocytokines and cytokines with the atherosclerotic lesions.        -  To evaluate the relationship between the abnormalities of the expression profiles of the          adipocytokines and cytokines of the EAT with the circulating levels and metabolic          parameters.        -  To compare the histological and inflammatory profiles of the EAT with the subcutaneous          adipose tissue for each patient individually.      Methodology multicentric, comparative study      Estimated enrollment 31 participants in total        1. st group of- 15 people living with HIV undergoing CABG (coronary heart disease HIV+          group)        2. nd group of- 16 people without HIV- undergoing CABG (coronary heart disease HIV- group)          People without HIV-will be matched to people living with HIV+ by : age (± 5 years) and          sex Outcomes      Primary outcome:      Comparative analysis of the inflammatory profile of the EAT : expression profile of the pro     and anti inflammatory cytokines and adipokines within the EAT in both groups of participants     : coronary heart disease HIV+ and HIV- groups      Secondary outcomes :        -  Determination of the EAT volume by echocardiography and cardiac scanner for both groups        -  Macroscopic profile of the EAT : adipocytes, fibrosis, endothelial cell density)        -  RT-PCR analyses : renin, adiponectine, PPARɣ        -  Comparatison of the inflammatory and macroscopic profiles between the EAT and the          subcutaneous adipose tissue in the two groups by ARN messagers analysis.      Eligibility Inclusion criteria HIV+ group        -  Men or women above the age of 18 years old, HIV1 seropositive for more than 6 months        -  Individual undergoing, for the first time, cardiac surgery for CABG        -  Affiliated with a social security regimen (the AME is not a social security regimen)        -  Signed the consent form      HIV- group        -  Men or women above the age of 18 years old, HIV seronegative        -  Individuals undergoing, for the first time, cardiac surgery for CABG        -  Affiliated with a social security regimen (the AME is not a social security regimen)        -  Signed the consent form      Non-inclusion criteria History of surgery for CBAG and/or congenital heart defect- being     under the tutorship or guardianship of the state or in custody of the justice system.      Statistical methods Categorical variables will be compared using Fisher's exact test.     Continuous variables will be compared using the Student's t-test (parametric) and the     Wilcoxon-Mann-Whitney test (non-parametric) as appropriate considering the data distribution.     (statistical analysis software STATA 11 (StataCorp, Texas, USA))      Provisional study planning and timetable Study start date: July 2013 Enrollment period: 32     months Subject participation duration: 24 hours Total study duration: 32 months Estimated     study completion date: end of March 2016   "
105955|NCT01899183|"     The effectiveness of surgical fundoplication in treating classical reflux symptoms is well     documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly     secondary to gastro-esophageal reflux disease (GORD) is far to be assessed.      The effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15%     to 95%; the spread of these data is largely attributable to disparate study design and     methodology, patient selection, and outcome metrics.      In order to assess whether anti-reflux surgery may have beneficial effects on chronic cough     allegedly secondary to GERD and to eventually identify the preoperative clinical profile     which could predict those positive effects, we considered two groups of patients presenting     with 1) GERD associated to chronic cough, 2), typical GERD who underwent anti-reflux surgery.   "
105956|NCT01899170|"     Chronic neuropathic pain affects millions of individuals worldwide. It causes marked     reduction of health, utility and quality of life and represents a considerable economic     burden to society due to loss of work capacity and large treatment expenses. The proposed     project will explore new and rational methods for deep brain stimulation treatment of     patients with severe chronic neuropathic pain, resistant to conventional treatment. Deep     brain stimulation is a neurosurgical procedure in which a small stimulating electrode is     implanted into deep brain areas. Furthermore, we will utilize new positron emission     tomography neuroimaging and a new prototyped technology, called targeted transcranial     magnetic stimulation, to predict the outcome of deep brain stimulation and localize brain     regions with maximum symptom relief for each patient. This will optimize the selection of     patients for deep brain stimulation and provide a rational customized choice of brain target     for each patient, without surgical intervention. Novel techniques will be validated on     healthy volunteers and at the same time provide new insights into the mechanisms underlying     brain stimulation and pain perception. The project has great clinical impact, potential for     innovative development and industrial spin-out, facilitates exchange for Danish research     talents and senior researchers with Stanford University and California Pacific Medical     Research Institute in San Francisco, and unites world leading experts in pain research and     clinical treatment to achieve its goals.   "
105957|NCT01899157|"     A prospective cross-sectional study evaluates nutritional status and its relationship to the     related factors in Thai HIV-infected patients who attending in out patient clinic.   "
107018|NCT01885286|"     The investigators are testing a novel surgical device to facilitate safe circumcision among     adult males. The investigators hypothesize that this device will allow non-medical providers     to perform safe surgical circumcision without adverse events.   "
105958|NCT01899144|"     This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,     single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with     persistent asthma. The primary purpose of this study is to compare the efficacy and safety of     Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose     levels equivalent to 90 mcg and 180 mcg of albuterol base.   "
105959|NCT01899131|"     1. To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok®          microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical          and radiographic evaluations.        2. To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and          soft tissues.        3. To perform clinical and radiographic evaluations on these abutment/implant assemblies up          to 2 years.   "
105962|NCT01899092|"     The study is a first in man, dose escalation study that will measure the safety and efficacy     of TT-034 in the treatment of patients with chronic hepatitis C. The study is divided into 5     dose levels. Subjects will be given a single dose delivered by IV infusion. The subjects will     be monitored and the data analyzed. After a set time, between 6 and 10 weeks depending on the     dose level, the next set of subjects will be dosed. The study drug is a gene therapy     treatment that produces molecules that destroy the Hepatitis C virus (HCV) in infected cells.     Once the study drug is given, it cannot be withdrawn. Additionally, once an individual     receives a dose, he or she will not be able to receive a second dose, but will remain     eligible to receive most other HCV treatments.   "
105963|NCT01899079|"     The primary objective of this study is to assess the extent to which the Prosigna™ Breast     Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment     recommendations regarding adjuvant chemotherapy and actual treatments received for patients     with early-stage breast cancer.   "
105964|NCT01899066|"     This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab     (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to     chemotherapy alone.   "
105965|NCT01899053|"     This study is a multicenter, open-label, phase 1b trial of MLN0128 (an oral mTORC1/2     inhibitor) in combination with MLN1117 (an oral inhibitor of the PI3K (alpha) isoform) when     administered to adult patients with advanced nonhematological malignancies.   "
105966|NCT01899040|"     This is a randomized, blinded study designed to assess the efficacy of a portable,     non-invasive neuromodulation system for the treatment of episodic migraine headaches.   "
105967|NCT01899027|"     The primary objective of this study is to test the hypothesis that twice overnight high-dose     rosuvastatin loading before RNA followed by 3-month treatment with regular doses of     rosuvastatin can reduce both the acute and late renal artery damage.   "
105968|NCT01899014|"     Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a     sensitive molecular tracer for PET-CT imaging that is taken up in activated cells and, as     such, is able to identify active inflammatory sites.   "
105969|NCT01899001|"     The purpose of this study is to help determine the best treatment plan for women with PCOS     who are overweight or obese and experiencing significant symptoms of depression and anxiety.      Specifically, the investigators are attempting to see if there is a difference between     cognitive behavioral therapy in combination with nutritional counseling in improving mood     symptoms, response to stress, and risk factors for heart disease compared to nutrition     counseling alone. The investigators hypothesize that combined treatment with Cognitive     Behavioral Therapy (CBT) and nutritional counseling will be more beneficial.   "
105970|NCT01898975|"     Optimal fluid management has been considered as crucial part to determine postoperative     outcome and organ function. Recently developed, non invasive cardiac output     measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO)     monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from NICOM     have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this     study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid     responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive     patients using gray zone approach.   "
105971|NCT01898962|"     Patients with metastatic cancer are usually treated with systemic therapy (treating the     entire body) with the assumption that any localized treatment of clinically apparent     metastases would not impact survival. In the setting of increasingly effective systemic     therapy and limited metastatic disease, aggressive treatment to clinically active sites of     disease (alone or in addition to systemic therapy) may improve survival.   "
105972|NCT01898949|"     Human fat tissue is essentially white fat, the main function of which is to store excess     energy intake, and to release it when necessary. Brown fat is far less abundant and is     present in the body to burn fat (and thus energy) to generate heat to maintain body     temperature around 96 degrees. This phenomenon is called thermogenesis. When humans are     exposed to cold on a chronic basis, brown fat expands and becomes more active, and     consequently burns more energy. The amount of brown fat is higher during winter, and daily     short (20 minutes) exposures to cold might be sufficient to induce its activity.      We hypothesized that daily short term (20 minutes) exposure to a cold environment (4 °C) for     four weeks increases adaptive BAT-mediated thermogenesis. CIT and DIT will be increased     proportionally (the increase in CIT and DIT will be correlated).   "
106238|NCT01895452|"     This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to     continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects     with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue     treatment.   "
105973|NCT01898936|"     Organ transplant recipients (OTR) have an increased risk of non-melanoma skin cancer, in     particular squamous cell carcinoma (SCC), often developing in areas of field cancerization,     areas with multiple precancerous actinic keratoses. The risk of developing SCC in OTR is     65-100-fold the normal population (Jensen 1999, Lindeløf 2000), and this cancer often runs a     more aggressive course with metastasis reported to occur in 5-8% of cases (Berg 2002). The     treatment options in field cancerization are limited. In Norway, the registered treatment     alternatives are the topical immune response modifier imiquimod and photodynamic treatment.     Neither of these treatments has shown long term beneficial effects.      In this study, we will study the effect of pre-treating the skin with ablative, fractional     carbondioxide laser before photodynamic therapy in a group of OTR with multiple actinic     keratoses   "
105974|NCT01898923|"     The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1     ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers     for up to 16 weeks.An additional objective of this study is to collect safety information     including adverse events and clinical laboratory abnormalities.   "
105975|NCT01898910|"     The investigators have conducted a prospective, double-blind, randomized study to assess the     comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD)     versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed     after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).   "
105976|NCT01898897|"     The study hypothesis is that regional anesthesia offers better outcome for the patients who     underwent robot assisted laparoscopic urogenital surgery.   "
105977|NCT01898884|"     The objectives of the study are:        -  To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in          subjects with Friedreich's ataxia (FA). [Primary]        -  To characterize the pharmacokinetics of VP 20629 by investigation of the plasma          concentration-time profile following single and multiple oral doses in subjects with FA.          [Secondary]        -  To investigate the pharmacodynamic effects of VP 20629 on plasma 8-isoprostane and          malondialdehyde and urinary 8-hydroxydeoxyguanosine concentrations following multiple          oral doses in subjects with FA. [Exploratory]   "
105978|NCT01898871|"     The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a     new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of     moderate acute malnutrition in children.   "
105979|NCT01898858|"     The aim of this study is to describe the pulmonary hemodynamic evolution at rest and during a     short constant load exercise in 4 conditions :        -  normoxia        -  hypoxia        -  hypercapnia        -  association hypoxia and hypercapnia   "
105980|NCT01898845|"     This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose     for expansion.   "
105981|NCT01898832|"     The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant     women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role     in progress of intrahepatic cholestasis of pregnancy.   "
105982|NCT01898819|"     Intraocular pressure is significantly increase during robot-assisted laparoscopic radical     prostatectomy which is performed in a steep trendelenburg position at prolonged timeds of     pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in     intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.   "
105983|NCT01898806|"     This study aims to determine the frequency of response to treatment with 3 concentrations of     IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side     effects compared to treatment with placebo (sterile saline solution). After the 1st 6 months,     nonresponders or partial responders may be treated for 6 months with open label triamcinolone     at the dose deemed appropriate by the investigator.      The investigators will also perform skin biopsies of the scalp and draw blood at selected     time points in order to examine the immunohistochemical/pathological response in scalp hair     follicles and the systemic circulation to treatment with IL TAC for alopecia areata.   "
105984|NCT01898793|"     This phase I/2 trial studies the side effects and best dose of activated natural killer cells     in treating patients with relapsed or refractory acute myeloid leukemia and myeloid     dysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps     stop the growth of cancer cells. It may also stop the patient's immune system from rejecting     the donor's natural killer cells. Modified natural killer cells may help the body build an     immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white     blood cells (including natural killer cells) to kill leukemia cells.      In the phase II portion of the study, the investigators intend to use maximal tolerated or     tested (MT/TD) CIML NK cell dose as determined from the phase I part of this study. The phase     II portion of the study also replaces IL-2 with ALT-803. The rationale for this change is to     support the donor derived NK cells in vivo after adoptive transfer.   "
105985|NCT01898780|"     The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B     and C) in horizontal mattress suture are lower than in interrupted suture during     pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.   "
105986|NCT01898767|"     The long-range goal of this protocol is to more completely understand the risks and the     pathophysiology of asthma exacerbations, in order to develop prevention strategies and/or     expedite a return to complete control of baseline asthma symptoms.   "
105987|NCT01898754|"     The investigators propose to gauge improvements in the rate of durable suppression of viral     replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope     Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at     Coptic Hope Center.   "
105988|NCT01898741|"     Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient     treatment options for locally advanced tumors and metastasized patients. High dose     radiotherapy with small margins seems feasible with current technical possibilities, e.g. by     fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and     technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced     pancreatic carcinoma.   "
107243|NCT01882348|"     The proposed study is a Randomized Controlled Trial designed to test the sustainability of a     previously developed, tested, effectively implemented tobacco control strategy—the CEASE     intervention, employing state of the art tobacco dependence treatment for parents who smoke.   "
105989|NCT01898728|"     The eye contains a lens that focuses light. A clouding of the lens is known as a cataract.     Cataracts decrease vision. The treatment for cataracts is cataract surgery. Cataract surgery     is one of the most commonly performed surgical procedures. Although rare, complications of     cataract surgery are significant given the number of people who have surgery each year and     more serious complications may have a significant impact on the vision and quality of     patients. Endophthalmitis is an infection in the eye and it is one of the worst complications     of cataract surgery. Most of these infections are caused by bacteria from the patient's skin     and conjunctiva, which makes cleaning the skin and eye before surgery very important. Before     cataract surgery, patients receive an umber of eye drops; many surgical centers have a     combination of medications in a thick gel, so that the medications remain in the eye for a     long period of time, which may improve their effect. Laboratory studies suggest that the     antibacterial effect of cleaning solutions may be inhibited by gels but this has not been     proven, and many believe it to be untrue. This study is to compare the amount of bacteria on     the eye prior to surgery in patients receiving a gel formulation of the medications before     surgery as compared to those receiving the same medication in eye drop (liquid) form.   "
105990|NCT01898715|"     This first-in-human study is designed to establish the safety and tolerability of ATR-101 in     patients with advanced adrenocortical carcinoma whose tumor has progressed on standard     therapy. Information will also be collected to determine how long ATR-101 stays in the blood,     and if any effect on tumor progression is seen. Biomarkers (blood and urine tests) will     determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen     and testosterone) are seen.   "
105992|NCT01898689|"     A continuous peripheral nerve block—also termed perineural local anesthetic     infusion—involves the insertion of a tiny tube (a catheter) through the skin and adjacent     to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the     catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be     provided in the hospital setting, but the use of lightweight, portable pumps permits infusion     at home as well. However, it remains unknown if the concentration of the local anesthetic     influences the block effects; or, is it rather simply the total dose of medication that is     important. If it is the latter, then the concentration of local anesthetic could be     increased, allowing a decreased basal infusion rate, which would allow patients at home to     receive twice the duration of potent pain control since their infusion pump local anesthetic     reservoir would last twice as long as current practice. In addition, if one     concentration/dose combination results in less muscle weakness, but with at least equivalent     analgesia, then the risk of falling might be decreased as well.      The investigators will test the hypothesis that providing ropivacaine at different     concentrations and rates (0.1% at 8 mL/hour vs. 0.4% at 2 mL/hour)—but at an equivalent total     basal (8 mg/hour)—produces comparable effects when used in a continuous popliteal-sciatic     nerve block.   "
105993|NCT01898676|"     A study in stable epilepsy patients comparing levels of valproic acid after administration of     brand and generic divalproex sodium extended release tablets.   "
105994|NCT01898663|"     The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells     (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with high-risk     soft tissue sarcoma. Experimental recombinant adenovirus-transfected DCs, which engineered to     express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our     previously performed preclinical study with DCs vaccine combined with CIK cells, the     investigators plan to perform the clinical trial.   "
105995|NCT01898650|"     Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together     earlier than normal. This causes the baby to have an abnormally shaped head. These children     are operated on to prevent or treat increased pressure on the brain, allowing for normal     development. There is not good evidence of which children with craniosynostosis have     increased pressure on the brain. Up to twenty patients with craniofacial abnormalities will     be enrolled in this pilot study. The investigators will use a magnetic resonance scanner to     obtain several measures of brain metabolism. The investigators will also obtain data which     are markers of developmental delay.      The results will also be compared to age and gender matched data from children without     craniofacial abnormalities.      There study hypothesis is that patients with craniofacial abnormalities associated with     intracranial pressure will have decreased metabolic activity compared to control patients.   "
105996|NCT01898637|"     The goal of this project is to determine if the change in oxygen saturation during deep     inspiration (augmented pulse oximetry) can be used as a method to rule out pulmonary     embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to     help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive     patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who     do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will record     each patient's oxygen saturation before, during, and after a 2-minute period of deep     inspirations (vital capacity [the maximal amount of air that can be inhaled, measured in     milliliters]) using an incentive spirometer. The investigators' central hypothesis is that     persons with a PE will not respond to augmented pulse oximetry and will not significantly     improve or normalize their oxygen saturation.   "
105997|NCT01898624|"     To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder     (OAB) patients with coexisting glaucoma.   "
105998|NCT01898611|"     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the     brain. The investigators already know that a single dose of Ghrelin improves food intake     immediately after the dose in frail older people. In addition, exercise programs have been     shown to improve strength and function in older people. In this study, the investigators are     trying to find out if a joint intervention of ghrelin and resistance training will improve     walking, balance and leg strength in frail elderly people.   "
106000|NCT01898585|"     This open-label, single-arm, multicenter study will assess the safety and efficacy of     Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma.     Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable     toxicity, consent withdrawal, death, reasons deemed by the treating physician or study     termination.   "
106001|NCT01898572|"     It has been hypothesized, based on recent trials, that only early intervention can reduce     cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This     finding may imply that atherosclerosis at diabetes diagnosed, is either negligible, or at     early, or non-advanced, still modifiable disease stage. However, sparse information is     available regarding atherosclerosis prevalence and its characteristics at diabetes     presentation. Furthermore, although cardiovascular disease (CVD) prevention is the major goal     of treatment in T2DM, risk assessment tools, mostly based on traditional CV risk factors,     lack of adequate specificity to identify individuals at higher risk. Therefore, non-invasive     tests, such as carotid ultrasound, have been recommended to better define CV risk in several     groups of individuals, including those with intermediate risk or with T2DM.      This clinical study aims to improve the investigators knowledge on cardiovascular disease     (CVD) in subjects with newly diagnosed T2DM (NEWDM). The investigators hypothesis is that     carotid ultrasound (carotid intimae media thickness [CIMT] and carotid plaque [CP]) will show     a worse subclinical/preclinical CVD stage in NEWDM compared with non-diabetic (CONTROL)     individuals. Moreover, carotid ultrasound will also identify T2DM individuals at a higher     risk in whom intervention should be more intensive.      Because individuals with T2DM have a higher prevalence of several CV risk factors, NEWDM will     be matched with CONTROL individuals, not only for age and sex (the main determinants of     atherosclerosis), but also for known, treated hypertension and dyslipidemia, and smoking     habit.      The investigators will study NEWDM and CONTROL individuals without clinical CVD. This is a     cross-sectional and longitudinal (18 months of follow-up) case-control study. The main study     variables will be carotid ultrasound derived variables. The main aims of the study are: 1) to     investigate CIMT and CP prevalence differences between NEWDM and CONTROL subjects; 2) to     characterize the subset of NEWDM subjects with a higher CIMT (≥ mean+1SD o ≥ P75th) or CP     presence; and 3) to early characterize individuals in whom subclinical CVD worsens (CIMT     progression ≥ mean + 1SD o ≥ P75th) even after standard (according to clinical guidelines)     diabetes treatment.   "
106142|NCT01896713|"     MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy     (TRUSBx) to improve identification of patients on active surveillance requiring treatment.   "
115194|NCT01778062|"     This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients     with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.   "
106002|NCT01898559|"     This study examines the effects of smoking little cigars in different groups of smokers. The     investigators are focusing on differences in how smokers' bodies break down and eliminate     nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they     break down and eliminate nicotine from their bodies more quickly. Other people are slower     metabolizers meaning they break down and eliminate nicotine more slowly. The investigators     are comparing these two groups of smokers when they switch to smoking cigars instead of     cigarettes.   "
106003|NCT01898546|"     Objectives. We will evaluate the effect of ischemic postconditioning (PCON) on microvascular     obstruction (MVO) in patients with a first ST-segment elevation myocardial infarction (STEMI)     treated with primary angioplasty.      Background. PCON appears as a potentially beneficial tool in STEMI. Its impact on MVO is     unknown.      Methods. In a multicenter study, 132 patients with a first STEMI will be randomized to     undergo primary angioplasty followed by PCON or primary angioplasty alone (non-PCON). MVO and     infarct size (IS) will be quantified (% of left ventricular mass) in a core laboratory     analyzing late enhancement cardiovascular magnetic resonance imaging.   "
106004|NCT01898533|"     In this study, investigators intend to measure changes in BOLD contrast in the breast induced     by breath-holding for subjects receiving radiation therapy to the breast. This study will     provide the preliminary data and experience needed to successfully apply BOLD to quantify     changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast     radiotherapy patients. The current study has the following objectives:        1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.        2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for          females undergoing radiotherapy   "
106005|NCT01898520|"     A study to assess the effects of Sativex treatment on spasticity in a population of children     and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous     system injury. Efficacy (ability to improve symptoms), safety and tolerability will be     monitored.   "
106006|NCT01898507|"     This study examines the effects of smoking low nicotine cigarettes in different groups of     smokers. The investigators are focusing on differences in how smokers' bodies break down and     eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning     they break down and eliminate nicotine from their bodies more quickly. Other people are     slower metabolizers meaning they break down and eliminate nicotine more slowly. The     investigators are comparing these two groups of smokers for their responses to low nicotine     cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes     may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine     levels, and as a result continue to be exposed to significant toxin levels.   "
106007|NCT01898494|"     This randomized phase II trial studies how well transoral surgery followed by low-dose or     standard-dose radiation therapy works in treating patients with human papilloma virus (HPV)     positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to     kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation     therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet     known how much extra treatment needs to be given after surgery.   "
106008|NCT01898481|"     The purpose of this pilot study is to test the feasibility of identifying and interviewing     healthcare triads (patients, loved ones and oncologists) in a research study and evaluate the     influences of patients' loved ones and oncologists on cancer treatment decision-making. the     study team plans to explore concordance or discordance within the triad about the decisions,     and also assess decisional conflict, regret and distress. Study methods involve interviewing     a total of 75 patients, their loved ones and oncologists about past cancer treatment     decisions. Analysis will consist mainly of qualitative content analysis. The investigators do     not anticipate risk or safety issues beyond loss of confidentiality or minimal discomfort     while discussing a cancer treatment decision.   "
106042|NCT01898039|"     This study is designed for patients who had malignant melanoma and, following tumor removal,     are now free of disease, or have only very minor residual disease, and are at a very high     risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma     vaccine, a compatible melanoma cell line that has been engineered to express a molecule     termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's     immune system, and to induce its stimulation. The hypothesis that drives the study states     that the immune response against the cell line will also be effective against the residual     tumor that may still be present in the body.   "
134304|NCT01526902|"     This study is designed to compare the relative performance related to subjective and     objective vision between two multifocal soft contact lenses.   "
106009|NCT01898468|"     Post-thoracotomy Pain Syndrome (PTPS) is defined as pain that recurs or persists along a     thoracotomy scar at least 2 months following surgery. PTPS presents a frustrating challenge     to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing     thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the     compression of the intercostal nerves during routine closure. Closure of thoracotomies using     intracostal sutures is a novel technique where sutures are passed through holes drilled into     the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized     control study involving 90 patients undergoing elective posterolateral thoracotomies.     Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures     or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at     3, 6, and 12 months after surgery between groups.   "
106043|NCT01898026|"     The proposed study will examine the effects of incorporating a soluble fibre blend into     commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood     glucose. A sensory evaluation will be conducted in phase I to asses for differences between     the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast     cereal. Phase II will be investigating the postprandial blood glucose responses of the 8 test     foods from phase I.   "
106153|NCT01896570|"     In this study, the investigators aim to examine the prognostic role of subsequent Atrial     Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the     investigators compare patients who were randomly assigned to either undergo cardioversion     after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.   "
106010|NCT01898455|"     This study will be looking at the clinical efficacy of using a intranasal evaporative cooling     device in providing relief of the symptoms of migraine and cluster headache. It will involve     using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates     and removes heat from the tissue, thereby cooling the tissue and the blood vessels which     supply blood to the brain. This cooling effect will cause the blood vessels to constrict and     it is thought that this may provide symptomatic relief in both these forms of headache. 10     migraine patients and 5 cluster headache patients will be enrolled in the study and will     receive 10 treatments each, for a maximum of 20 minutes at a time. They will be monitored     during the treatment and for two hours afterwards to assess headache severity and side     effects. There will be a further follow up 2 months after the last treatment to assess for     longer term side effects from the treatment.   "
106011|NCT01898442|"     Ticagrelor is a reversible direct acting P2Y12 antagonist, which has shown to be superior to     clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Ticagrelor is     considered a first line therapy to be administered as soon as possible in ACS patients.     However, the pharmacodynamic effects of ticagrelor at the recommended 180mg loading dose are     delayed in patients with STEMI undergoing primary PCI. The use of higher loading dose     regimens of ticagrelor has therefore been advocated. The proposed investigation will have a     prospective, randomized, parallel design in which STEMI patients undergoing primary PCI will     be randomized to receive three different loading dose of ticagrelor (180 mg, 270 mg and 360     mg). Pharmacodynamic testing will be performed at several time points to test our study     hypothesis that a higher loading dose regiment will achieve more promptly enhanced platelet     inhibitory effects.   "
106012|NCT01898429|"     In this pilot study, we propose to test whether high frequency stimulation of the subcallosal     cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to     compare the effects of left-sided vs. right-sided stimulation, and to investigate potential     mechanisms of action of this intervention. Importantly, this study will be used to assess the     need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.   "
106013|NCT01898416|"     The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral     administration and subsequently intraoperative tumor bed phototherapy with red light laser,     as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid     tumors. To evaluate the Safety of 5-ALA administration. 5 years local recurrence rate.   "
106014|NCT01898403|"     This clinical trial compares and contrasts lymph node mapping using indocyanine green     (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc)     sulfur colloid (TSC).      Study participants with malignant melanoma will undergo all 3 evaluations to assess the     extent of the spread of the melanoma.   "
106015|NCT01898390|"     The Transeuro Transplant study is a trial which will involve grafting foetal tissue into the     brain of patients with Parkinson's disease, who are already been followed in the     observational study. The tissue inserted in the brain is to help replace and rebuild lost     dopamine from the brain due to Parkinson's disease. Only 20 patients will be selected for the     transplant.   "
106016|NCT01898377|"     In this study we will combine mycophenolate mofetil and imatinib mesylate to treat     steroid-refractory sclerotic/fibrotic type chronic graft-versus-host disease (GVHD) to see     the response rate and to find the safety of combination.   "
106017|NCT01898364|"     Primary Objective:      To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa     treated late-onset Pompe disease patients.      Secondary Objective:      To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and     alglucosidase alfa treated late-onset Pompe disease patients.      To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and     alglucosidase alfa treated late-onset Pompe disease patients.   "
106018|NCT01898351|"     Summary      This research will examine the nutritional effects of supplementing diets with alternative     plant sources of protein with potential to be grown in Scotland. In particular, we will     assess the potential of these plant protein sources to complement diets in which the     predominant source of protein is meat. These protein sources will include plants from the     Fabaceae, Cannabaceae and Polygonaceae families, which could be used as the basis for the     development of new foods. The research will assess if these plant proteins can deliver a     comparable alternative to meat based diets.      It is anticipated that the results could encourage increased consumption of plant products     which would be favorable for consumers shifting away from animal-derived proteins for health     and/or environmental reasons.      Hypothesis: Consumption of protein rich plants could be a sustainable and healthy choice for     partial replacement in predominantly meat based diets.      Objective: The objective of this acute study is to assess satiety, postprandial effects,     metabolite bioavailability and metabolism of single alternative proteins from a shortlist     including buckwheat, fava beans, lupin, pea, and hemp in comparison with red meat.      Study protocol      Aims: To assess the impact of a pea, fava bean, lupin, hemp, buckwheat in comparison with     meat in healthy people on:        -  Biomarkers of satiety as measured by gut-related hormones and subjective appetite using          visual analogue scales, specifically to be collected during the meal over a three hour          period, every 30 minutes. The energy intake measured for each volunteer after an ad          libitum lunch (five hours after test meal).        -  Biomarkers of CVD risk including total cholesterol, low density lipoproteins (LDL), high          density lipoproteins (HDL), triglycerides and non-esterified fatty acids (NEFA).        -  Assessment of peripheral glycaemic control, fasting glucose, area under the curve          combined with insulin data.        -  Plasma and urine markers of important phytochemical and protein metabolites will be          quantitatively analysed to determine the systemic availability, in vivo concentrations          and excretion times.        -  Volunteer views towards diets rich in plant proteins will be assessed.   "
106019|NCT01898338|"     To demonstrate that the combination of daptomycin and fosfomycin is superior to daptomycin     alone in the treatment of methicillin resistant Staphylococcus aureus (MRSA) bacteremia.   "
107378|NCT01880580|"     The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging     (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary     data for a future extensive clinical trials.   "
106044|NCT01898013|"     The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to     determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain. The     total study duration is 6 weeks (followed by two-follow up phone calls). All patients will     monitor pain symptoms for one week with pain diaries, followed by a 1-week placebo-only     lead-in period, 90 subjects will be randomly assigned to one of two groups. Of these     subjects, 45 subjects will receive pregnenolone, and 45 subjects will receive placebo for 4     weeks. Patient interview assessments and laboratory studies will be performed at each     interview time point. Pregnenolone, allopregnanolone and other neurosteroid metabolites will     be determined by gas chromatography / mass spectrometry (GC/MS), proceeded by high     performance liquid chromatography (HPLC).   "
106020|NCT01898325|"     The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher     disease divided into two groups, naive GD patients and GD patients treated with ERT. As liver     biopsy in these patients not recommended because the risk of bleeding using Fibroscan is a     safe with diagnostic accuracy regarding the liver (& Spleen) fibrosis. Estimating spleen     fibrosis is an innovative approach in liver disease and Gaucher.      The evaluation of fibrosis with this new and safe method could avoid complications     antiinvasive procedure in GD patients. The addition of fibrosis biomarkers will help for     patients score evaluation. The finding of liver and spleen stiffness will be evaluated in     native and ERT treated Gaucher patients in order to assess ERT effect on fibrosis.      The Aims are: 1) To assess liver and spleen stiffness measurement using fibroscan and     evaluate liver and spleen fibrosis in patients with GD.      2) To compare the elastography in two cohorts of GD patients: ERT treated and naïve GD     patients and two control groups of patients: healthy and Non Alcoholic Steatohepatitis (NASH)     patients.      3) To correlate the elastography findings with clinical and laboratory data in the four     patient groups focusing on Gaucher disease manifestations and GD severity. To compare the     elastography in GD naïve and ERT treated patients.   "
106021|NCT01898312|"     Ovarian steroids, as well as their synthetic counterparts gestagens and estrogens have a role     in breast cell proliferation and the development of breast cancer. Here, the effect of a     progesterone receptor modulator, mifepristone, on cell proliferation in human breast tissue     in vivo will be studied in women with BRCA-1 or -2 mutations. Our preliminary results     implicate a possible protective effect of mifepristone in breast epithelium. The ability of     mifepristone to block breast epithelial cell proliferation may prevent tumorigenesis and may     also prove beneficial when used for contraceptive purposes and on other indications. The     proposed project concerns a Randomized Controlled Trial on mifepristone versus placebo     treatment of women with BRCA-1or -2 mutations with a high risk/incidence of breast cancer and     ovarian cancer.   "
106022|NCT01898299|"     The purpose of the present research is to test a potential new treatment for auditory verbal     hallucinations in schizophrenia that uses transcranial Direct Current Stimulation (tDCS), a     neurostimulation technique that passes an extremely weak electric current through the brain.     During the treatment, two electrodes are positioned on the scalp above regions of the brain     implicated in abnormal cortical activity associated with auditory verbal hallucinations in     schizophrenia. Due to the directional flow of current, one electrode, termed     cathodal,inhibits cortical activity, and the other, termed anodal, increases cortical     activity. These electrodes will be placed such that cathodal stimulation is applied to an     area associated with hyperactivity and anodal stimulation to an area associated with     hypoactivity. One preliminary study has revealed that this form of neurostimulation can     alleviate auditory verbal hallucination symptoms both immediately following five days of     treatment and up to three months after the final treatment. The goal of this study is to     replicate these effects and explore the mechanisms that may underpin them.   "
106023|NCT01898286|"     This is an extension study to evaluate the safety and tolerability of long-term treatment     with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters     of metabolic control and on preservation of beta-cell function in subjects who have long     exposure to DiaPep277®.   "
106024|NCT01898273|"     The primary objective of this trial is to determine the optimal dose and imaging time     point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in     future trials.   "
106025|NCT01898260|"     The purpose of this study is to compare the subjective performance of two daily disposable     contact lenses with respect to comfort and handling.   "
106026|NCT01898247|"     The goal of the proposed research is to investigate the use a medical simulation and mastery     learning (where all learners must reach a high standard before completion of training)     curriculum to improve internal medicine residents' skills when performing thoracentesis     procedures (remove fluid from around the lung) on patients. Additionally, we will evaluate     how these skills affect patient outcomes by comparing thoracenteses performed by     simulator-trained residents to those who have traditional training. This project will     evaluate these overall hypotheses: simulation-based training using the mastery learning     approach improves medicine resident's thoracentesis skills and improves patient outcomes and     satisfaction.   "
106027|NCT01898234|"     Background:      High- and low-flux dialysis membranes made of different materials may correlate with various     hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and     incidence of hypotensive episodes by comparing some of the most commonly used high- and     low-flux dialyzers.      Methodology:      The study was designed as an open label, randomized, cross-over investigation, including 25     patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear,     Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux,     Fresenius), were compared with each other. The hemodynamic profile was assessed with a     non-invasive technique and patients were asked to provide tolerance feedback through a     questionnaire.   "
106028|NCT01898221|"     The broad, long-term objective of this project is to evaluate the therapeutic value of vein     of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation     (AF). AF is the most common sustained arrhythmia in adults, and it is a leading cause of     stroke, disability and increased mortality. Catheter ablation - pulmonary vein (PV) antral     isolation (PVAI)- can lead to cure, but is best suited for paroxysmal AF, in which ectopic     beats arising from the pulmonary veins were shown to initiate AF. PVAI success is lower in     persistent AF, in which the role of the cardiac autonomic system, particularly the intrinsic     cardiac ganglia, is being increasingly recognized. Expanding the ablation lesions to include     greater areas the left atrial (LA) anatomy marginally improves outcomes, but also leads to     increases in procedural complexity and duration, need of repeat procedures, and complications     such as atrial flutters, particularly perimitral flutter (PMF). The investigators have     developed a technique to perform rapid ablation of atrial tissues in AF using ethanol     infusion in the vein of Marshall (VOM), and have shown: 1) Effective, rapid and safe tissue     ablation of LA tissue neighboring the LA ridge and left inferior PV; 2) Regional LA vagal     denervation by reaching the intrinsic cardiac ganglia; and 3) Facilitation of cure of PMF by     ablating most of the mitral isthmus.      The investigators propose to evaluate outcomes differences yielded by VOM ethanol when added     to conventional PVAI. The specific aims are: #1.To assesses the impact of VOM ethanol     infusion in procedure success when added to de novo catheter ablation of persistent AF. The     investigators will randomize patients with persistent AF undergoing a first AF ablation to     standard PVAI vs. a combined VOM ethanol infusion plus PVAI (VOM-PV) #2. To assess the impact     of VOM ethanol infusion added to repeat catheter ablation of recurrent AF after a failed     ablation. Patients undergoing a repeat procedure for persistent AF after a failed PVAI will     be randomized to either PVAI or VOM-PV as their repeat procedure. End points will include     freedom from symptomatic or electrocardiographic AF after 12-15 months.   "
134831|NCT01520012|"     The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808     100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.   "
106030|NCT01898195|"     Smoking rates among individuals living with HIV/AIDS range between 47% and 65%, a prevalence     that is roughly three times the rate of the general population. This elevated prevalence is     alarming given the increased likelihood of numerous adverse health outcomes experienced by     HIV-positive smokers. Cigarette smoking is associated with greater levels of HIV-related     symptom burden and appears to decrease the effectiveness of HAART as assessed by both viral     load and CD4 counts (Vidrine 2009, Marshall 2009, Vidrine 2007, Miguez-Burbane 2005). PLWHA     who smoke are also at increased risk of infections and noninfectious pulmonary complications     and both AIDS-associated and non-AIDS-associated malignancies compared to nonsmokers. This     study will refine and pilot test a theory-driven smoking cessation intervention that enhances     existing behavioral approaches by testing the impact of text message reminders to take     varenicline and the feasibility and additional impact of including adherence-focused     behavioral cessation counseling. The investigators propose to randomize 190 participants,     recruited from three HIV/AIDS clinic, to a three arm pilot study that compares: 1) Standard     Care (SC), 2) SC + text message reminders, and 3) SC + text message reminders + cell     phone-delivered adherence-focused behavioral therapy (ABT). Participants in all three arms     will receive varenicline for 12 weeks. The primary outcomes are adherence to varenicline and     biochemically validated smoking abstinence at 12 weeks and 3-month follow-up from the time of     study enrollment.   "
106031|NCT01898182|"     The purpose of the study is to evaluate the change in the severity and clinical signs of skin     photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will     recruit 132 subjects from dermatological clinics in a tertiary hospital in the Philippines     for a period of 3 months (12 weeks). Changes in severity will be documented using physician     evaluation, self-evaluation, and through VISIA complexion analysis system.   "
106032|NCT01898169|"     Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes     have gained in popularity over the last several years. The technology used to manufacture     ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content,     e-liquids and flavorings. Only in the last few years have researchers begun to examine the     health risks and benefits, nicotine blood levels, patterns of use, likability, and craving     and withdrawal relief of ENDS. These studies have shown great variability in nicotine     delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS     brands among tobacco cigarette smokers.      This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is     a single use unit that resembles a traditional cigarette and delivers approximately 150     puffs. The cartridge inside contains 26 milligrams of nicotine.      Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on     heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes     and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns     for cigarettes and NJOY King ENDS during a one-week period in which they can use each freely.      The study includes three visits to the clinic spaced approximately one week apart. Subjects     who pass the screening visit will return to the clinic for Visit 2 in which they will sample     the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one     week later. They will be instructed to use as many or as few as they like during the week.     Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of     e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of     abstinence from any form of nicotine in order to assure that they have no nicotine left in     their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY     Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be     measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4)     craving for cigarettes and nicotine withdrawal symptoms will be assessed.   "
106033|NCT01898156|"     This Phase 1/2 study is designed to assess the following: safety and tolerability of     BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2     Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and     preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.   "
106034|NCT01898143|"     Whole body vibration training seems to be a useful adjunct in exercise training in patients     with severe COPD. The basic principle relies on reflectory muscle contractions caused by a     vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary     parameters remained unknown. Therefore aim of this study is to investigate cardiopulmonary     parameters during whole body vibration training in patients with chronic lung disease.   "
106035|NCT01898130|"     This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease     has spread to their brain. This study will not evaluate the effect of bevacizumab on the     systemic solid tumor cancer. Bevacizumab is a medication and it is thought that bevacizumab     may interfere with the growth of new blood vessels; therefore it might stop tumor growth and     possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the     blood vessels.   "
106036|NCT01898117|"     Triple negative breast cancer (TNBC) is a difficult to treat molecular subtype with a poor     survival. TNBC can be divided into at least two molecular entities; BRCA-like and     non-BRCA-like. In this trial we would like to investigate whether a molecular subgroup exists     within TNBCs that derives a benefit from bevacizumab added to first line chemotherapy.   "
106037|NCT01898104|"     The purpose of this study is to first determine the maximum tolerated dose of capecitabine     given alone or in combination with valproic acid during preoperative short-course     radiotherapy (Phase 1). The next part of the study (Phase 2)will explore whether the addition     of valproic acid or the addition of capecitabine to short-course radiotherapy, before optimal     radical surgery might increase the pathologic complete tumor regression rate in patients with     low-moderate risk rectal cancer.   "
106038|NCT01898091|"     This study involves adults receiving radiation therapy for head and neck cancer and will test     whether or not the study mouthrinse may lessen oral mucositis.   "
106039|NCT01898078|"     This is an open-label, multicenter, phase 1 study with the primary objective of evaluating     the effect of food on the single-dose PK properties of alisertib administered as the ECT     formulation. The secondary objective is to further evaluate the safety and tolerability of     alisertib.   "
106040|NCT01898065|"     With functional imaging development, it becomes possible to increase radiation dose to     radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This     strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role     in the resistance of these tumors to radiation.      In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we     should characterize changes in hypoxia before treatment and during radiotherapy.        -  If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by          an integrated boost is performed.        -  If hypoxia varied (increasing or incomplete regression), a final boost strategy of          radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a          first fractionated IMRT could be considered.      This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available     tool to physicians in assessing tumor hypoxia.   "
106045|NCT01898000|"     The present study was a randomized control clinical trial, which included 90 subjects with     chronic generalised gingivitis of age group 25-40 years, reporting to outpatient department     of Periodontics, Government Dental College & Research Institute, Bangalore form January 2013     to April 2013. The research protocol was initially submitted and approved by the     Institutional Ethical Committee and Review Board of the Government Dental College and     Research Institute, Bangalore. After ethical approval, all subjects were verbally informed     and written signed informed consent was taken for participation in the study.      Ninety subjects diagnosed with chronic generalized gingivitis were randomly assigned into     three groups: Group I: Placebo mouthwash, Group II: Triphala (TRP) mouthwash, Group III:     Chlorhexidine (CHX) mouthwash. Subjects were instructed to use mouth wash twice daily. The     plaque index (PI), gingival index (GI) and oral hygiene index- simplified (OHI-S) and     microbiological colony counts were recorded on baseline (B/L) and 7, 30 and 60 days     respectively.      TRP mouthwash was found to decrease the inflammatory parameters. As improvement in gingivitis     was comparable to that of CHX mouthwash thus TRP mouthwash can be considered as a potential     therapeutic agent in treatment of gingivitis.   "
106046|NCT01897987|"     This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM®     versus placebo, for the treatment of BPD in premature infants. Subjects who participated in     and completed the initial stage of the Phase II trial (NCT01297205 ) will be followed-up     until 60 months of corrected age.   "
106047|NCT01897974|"     Children with seizure disorder face unique challenges during the perioperative period.     Fasting, sleep-deprivation, and missed doses of medications while patients are required to     have nothing per mouth (NPO) are a few factors that decrease the seizure threshold. The     incidence of seizures in this population is unknown but correlated with patient's underlying     condition and missed doses of anti-convulsant. Previous work has determined this is not a     unique problem.      The investigators initially found compliance extremely poor at 60%. The investigators have     made improvement to about 80% compliance through various interventions: education of nursing,     availability of anticonvulsant intravenous dosing alternatives, and re-wording the hospital     NPO policy. The investigators feel that a new, more focused, survey will help identify,     perioperative reasons for non-compliance on part of the parents. This information will be     utilized to guide further interventions aimed at improving compliance.   "
106048|NCT01897961|"     The Membranous nephropathy (GEM)idiopatic is the most frequent cause of syndrome néphrotique     at the adult and represent approximately 2 % of the causes of terminal chronic renal     insufficiency. A etiology balance assessment must be systematically realized to eliminate a     secondary cause. Antibodies managed against the receiver of phospholipases A2 secreted by     type M (PLA2R1) was recently detected in a population of GEM idiopatic, but not secondary     GEM. PLA2R1 is expressed by the podocytes of the glomerules of healthy subjects, and this     receiver co-is located with the deposits of extramembraneous IgG of the expanding subjects of     idiopathique GEM. The good IgG the extramembraneous depositsof GEM idiopathic recognize     PLA2R1. At some patients, the activity anti-PLA2R1 seems to decrease or to disappear during     the stake in forgiveness of the disease.      Some cases of second offense of GEM idiopathique after renal transplantation presenting     antibodies anti-PLA2R1 have also described. The appearance of antibody anti-PLA2R1 seems     parallel to the increase of a proteinurie in touch with a second offense of GEM, and     antibodies sometimes disappeared after a therapeutic strengthening by Rituximab allowing to     obtain a forgiveness.      A GEM can also appear of novo on the renal transplant, it is to say without notion of GEM on     the native loins. The physiopathology of this affection remains unknown.      Working hypothesis and objectives We shall look in which proportion the presence of antibody     anti-PLA2R1 is associated with the second offense of GEM idiopathic in renal transplantation.     We anticipate that the GEM of novo of the renal transplant answers a different     physiopathology, and will not be associated with the presence of antibody anti-PLA2R1. We     hope to demonstrate that at the expanding patients of antibody anti-PLA2R1, the title of     these antibodies is correlated in the activity of the disease and in the renal survival, and     that the longitudinal follow-up of the title of these antibodies has an interest forecast and     therapeutics.   "
106049|NCT01897948|"     This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate     the relation to cognitive outcomes.   "
106050|NCT01897935|"     This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM).     Patients meeting the inclusion/exclusion criteria will receive a standard eye examination     including a slit lamp examination to collect ocular flare data. In addition to the standard     eye examination, subjects will receive flare measurements using the OFAM device.   "
106051|NCT01897922|"     This clinical trial will evaluate an investigational infant formula with a probiotic to     determine if it provides normal growth and if it is well tolerated by term infants compared     to a marketed routine infant formula.   "
106052|NCT01897909|"     The main objective of the study is to investigate the impact of H. pylori infection on immune     activation and clinical outcome in HIV patients.      Other specific study objectives are:        1. To investigate the effects of H. pylori infection on immune activation and the T-cell          profile in HIV positive patients and compare those with HIV negative controls.        2. To assess the influence of H. pylori infection on virological and immune parameters, and          on clinical progression of HIV infection (WHO stage, opportunistic infections).        3. To assess the prevalence of H. pylori infection among HIV patients in the Komfo Anokye          Teaching Hospital.        4. To assess the prevalence of gastrointestinal symptoms in HIV patients in Kumasi.        5. To assess the association of H. pylori infection with gastrointestinal symptoms and          pathology in HIV patients.        6. To compare the clinical and immunological response to antiretroviral therapy and in          HIV-patients with and without concomitant H. pylori infection.   "
106053|NCT01897896|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     SD-809 ER in subjects switching from tetrabenazine to SD-809 ER. In addition, the safety and     tolerability of long term treatment with SD-809 ER will be assessed in Switch subjects as     well as Rollover subjects completing a randomized, double blind, placebo controlled study     of SD-809 ER,   "
106054|NCT01897883|"     The purpose of this study is to provide current and reliable data of dyslipidimia management     together with control situation of blood pressure and glucose for post-stroke patients within     6-12 months from attack, and also the association between patient characteristics and control     rate of lipids in this population.      It is an non-interventional study, no study specified treatment is required.Approximately     5000 post ischemic stroke patients within 6-12 months from attack will enter into the study.     Fifty centres from different regions of China will participate in this study.   "
106055|NCT01897870|"     the purpose of this study is to determine the the effect of a home-based medication     management program on drug-related problems post-discharge.   "
106169|NCT01896362|"     The aim of this work was to investigate the healthcare professionals' knowledge about     leishmaniasis in Divinópolis, an endemic county of Minas Gerais state, Brazil.   "
106056|NCT01897857|"     In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is     commonly performed for continuous monitoring of systemic blood pressure and intermittent     assessment of arterial blood gases. The radial artery is the preferred artery, because of its     well-documented low complication rate and easy access, but, radial artery cannulation is may     associated with complications. Atherosclerosis is a systemic phenomenon, and structural     changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and     reduction in distensibility occur frequently throughout the arterial tree. Especially in     patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and     perhaps calcification. In a recent study, it was found that the radial artery flow was     decreased immediately after cannulation, but recovered to its pre-cannulation value after     5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately     after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical     status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory     increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis,     particularly in patients with DM. In our study, we found whether there is appropriate     compensatory increase of blood flow in the ulnar artery after the radial artery cannulation     in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing     elective kidney transplantation.   "
106057|NCT01897844|"     The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as     double-blind, placebo-controlled, randomized, tested an extended dosing regimen, i.e. 14     consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label,     continuous subcutaneous infusion for 7 days were tested as ascending doses of ITF2984 up to     9000 mcg/day of ITF2984.   "
106058|NCT01897831|"     In the proposed study, the investigators plan to evaluate the efficacy and safety of     Piperacillin sodium and sulbactam sodium for injection (2:1) for the treatment of respiratory     and urinary tract acute bacterial infection under the widely used in clinical conditions.   "
106059|NCT01897818|"     ALS is a severe progressive neurodegenerative disease characterized by degeneration motor     neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all     motor skills as well as the possibility of communication written and oral developing a state     close Locked In Syndrome (LIS). The main objective is to establish the feasibility of     brain-computer interface using the pathological condition, with dependent disabled subjects     as a means of communication.   "
106060|NCT01897805|"     Title:      A randomized, double-blind, multi-centered, placebo-controlled trial to examine effects of of     Heart-protecting Musk Pill on clinical outcomes in patients with chronic stable coronary     artery disease      Objective:      To examine effects of of Heart-protecting Musk Pill, a traditional Chinese medicine, on     clinical outcomes in patients with chronic stable coronary artery disease      The study hypothesis:      The null hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial     infarction, nonfatal stroke in the treatment group is the same as that in control group.      The alternative hypothesis: the combined incidence of cardiovascular death, nonfatal     myocardial infarction, nonfatal stroke in the treatment group is different from that in     control group.      Sample size:      2700 patients will be randomized, 1350 in treatment group and 1350 in placebo group.      Number of sites: 99 sites in China      Study drugs:      Heart-protecting Musk Pill and the matching placebo pills.      Design:      A randomized, double-blind, multi-centered, placebo-controlled trial. Patients will be     randomized to treatment group and placebo group after screening and get corresponding     treatment as follow.      Treatment group: Standard treatment for coronary artery disease plus 2 Heart-protecting Musk     Pills each time, three times a day by mouth for 24 months.      Control group: Standard treatment for coronary artery disease plus 2 placebo pills each time,     three times a day by mouth for 24 months.      Patients will be followed up at baseline, 1, 3, 6, 9, 12, 18, 24 months after randomization.     During follow-up period, patients could undertake PCI or CABG if angina get out of control or     evidence of ischemia aggravated is found.   "
106061|NCT01897792|"     The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and     E) on the development of coagulation derangements and nosocomial pneumonia after severe     trauma in patients.   "
106062|NCT01897779|"     RPX7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem     (RPX2014) to treat bacterial infections, including those due to multi-drug resistant     bacteria.   "
106063|NCT01897766|"     The objective of this surveillance is to collect Safety and Effectiveness information for     Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).   "
106064|NCT01897753|"     The purpose of this protocol is to retrospectively study the influence of age at start of     growth hormone (GH) treatment on height gain in children born small for gestational age     (SGA).   "
106065|NCT01897740|"     The purpose of this study is to provide Sildenafil therapy for subjects who completed     A1481156 study and are judged by the investigator to derive clinical benefit from continued     treatment with Sildenafil, prior to reimbursement and availability for subjects in the     Russian Federation.   "
134967|NCT01518218|"     The objective of this study is to evaluate the effectiveness of 1-year administration of     laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in     Africa.   "
106073|NCT01897636|"     Pancreatic cancer is the second most frequent gastrointestinal malignancy. The overall     survival is dismal. Especially for advanced pancreatic cancer, the conventional approaches     are typically not curative and provide only minor increases in survivals in most cases.     Dendritic cells (DCs) are powerful antigen-presenting cells (APCs) that play a pivotal role     in the initiation, programming, and regulation of tumor-specific immune responses. Isolated     DCs loaded with tumor antigen ex vivo and administered as a cellular vaccine have been found     to induce protective and therapeutic anti-tumor immunity in experimental animals. Some     clinical trials of DC vaccination for cancer patients have shown the induction of anti-tumor     immune responses and tumor regression. Endoscopic ultrasound (EUS) is an established     technique for the diagnosis and staging of pancreatic cancer. Endoscopic ultrasound guided     fine-needle direct injection of dendritic cells vaccination into pancreatic tumors may be a     promising treatment modality.Therefore, The purpose of the study is to evaluate the efficacy     and safety of endoscopic ultrasound guided fine-needle injection of DCs vaccination into     advanced pancreatic cancer   "
106066|NCT01897727|"     Hypertension affects an estimated 60-70 million Americans, predisposing them to potentially     life threatening cardiovascular complications. Resistant hypertension, defined as     uncontrolled blood pressure on 3 or more different antihypertensive agents, is common,     affecting 15-20% of the entire hypertensive population or an estimated 12-14 million     Americans. Although associated with obesity, increasing age, black race, and chronic kidney     disease, mechanisms of treatment resistance remain obscure. The investigators' laboratory     identified primary aldosteronism (PA) as a common cause of treatment resistance with a     prevalence of 20% among subjects with resistant hypertension. This is clinically important     because recognition of PA can lead to effective treatment with use of aldosterone blockers.     Obstructive sleep apnea (OSA) is strongly associated with and predicts development of     hypertension as demonstrated in landmark cohort studies including the Sleep Heart Health     Study and the Wisconsin Sleep Cohort Study.      The investigators' laboratory has confirmed OSA to be extremely common in subjects with     resistant hypertension, with a prevalence of approximately 85%. Recognizing that PA and OSA     are exceptionally common in subjects with resistant hypertension, the investigators     hypothesized that the 2 may be causally related. In testing this hypothesis, the     investigators recently reported that plasma aldosterone levels are positively correlated with     OSA severity in subjects with resistant hypertension but not in normotensive control     subjects. This observation suggests that there is an important mechanistic interaction     between untreated OSA and aldosterone excess in subjects with resistant hypertension. While     the investigators' original hypothesis was that OSA stimulates aldosterone release, the     investigators recognize that the opposite may also be true; that is, aldosterone excess in     subjects with resistant hypertension worsens OSA. Distinguishing between these two     possibilities has potentially far-reaching clinical implications. If the former hypothesis is     true, effective treatment of OSA would be expected to suppress aldosterone release in     subjects with resistant hypertension, thereby reversing the underlying cause of their     treatment resistance. If the latter hypothesis is true, use of mineralocorticoid receptor     antagonists would be expected to reduce OSA severity in subjects with resistant hypertension,     thereby enhancing treatment of OSA. Either scenario would represent a new treatment approach     for a highly prevalent and serious medical problem.   "
106067|NCT01897714|"     The study will explore escalating doses of melflufen in combination with dexamethasone in     small groups of patients to find the maximum tolerated dose of melflufen. That dose will then     be used to determine the efficacy and safety profile of melflufen in combination with     dexamethasone in a larger group of patients.   "
106068|NCT01897701|"     This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old.     Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza     immunization within the past three months. Proportions of subjects in the various strata will     not be pre-specified; rather, the goal will be to achieve an approximately equal distribution     of subjects with these characteristics across the various treatment groups.      Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in     alternate deltoids. For each subject, study follow-up will span approximately 385 days total,     or approximately 13 months from the first dose.   "
106069|NCT01897688|"     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells     are destroyed, resulting in poor blood sugar control. The purpose of this study is to     determine the safety and effectiveness of islet transplantation, combined with     immunosuppressive medications, specifically using Campath as induction, for treating type 1     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic     episodes.   "
106070|NCT01897675|"     Management of abscesses traditionally involves incision and drainage (I&D). Abscesses are     frequently are packed or stented open with the presence of a wick, and traditional care     requires re-visits every 2-3 days to have the packing removed and replaced, until finally the     abscess cavity has closed, usually 1-2 weeks after initial presentation.      Recently there have been attempts to employ less invasive techniques for abscess management.     One novel technique, loop drainage, has been reported in case reports/case series for     management of a variety of types of abscesses in the surgical subspecialty literature.      We propose to conduct a randomized prospective study comparing the efficacy of the loop     drainage technique with the traditional incision and drainage technique of abscess     management.      Patients presenting to the main or urgent care areas of the Emergency Department at Boston     Medical Center for treatment of an abscess will be considered for enrollment as potential     subjects. After the treating clinician identifies the patient as an appropriate subject, a     Research Associate (RA) will approach the patient and obtain written informed consent to     enroll in the study. The subject will then be randomized to the management arm of either loop     drainage or traditional I&D. The clinician will fill out a data sheet describing the abscess     characteristics, and then perform either loop drainage or incision and drainage, depending on     randomization and the subject will fill out a satisfaction survey. Fourteen days after     initial visit, subjects will return for follow-up. The subject will fill out a satisfaction     survey, and a study investigator blinded to the treatment group will assess the subject for     abscess resolution, cosmetic outcome, number of follow-up visits, and complications.      The study investigators will then compare outcomes between the two study groups.   "
106071|NCT01897662|"     NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat     starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble     in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon     where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this     ingredient is a soluble dietary fiber. Recent work in China in overweight volunteers have     shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing     weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of     interest in the management of overweight or obese. Among the possible mechanisms of action,     are the metabolites produced by colonic fermentation of NUTRIOSE.      The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE     FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance     in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is     proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on     satiety and satiation and changes in colonic flora and its metabolites.   "
106072|NCT01897649|"     NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat     starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble     in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon     where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this     ingredient is a soluble dietary fiber. The objective of this research is to determine,     among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and     digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed     by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by     volunteers.   "
106095|NCT01897350|"     Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain     functional and anatomical information on the heart. Several CMR parameters measured after     primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value     and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema     is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated     as the myocardial oedema minus infarct size; this again is a prognostic indicator following     STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences     available, with no standardisation of sequences used to assess this surrogate endpoint. The     investigators propose to conduct a study to measure the myocardial oedema by all available     techniques to determine the agreement between these methods.   "
135136|NCT01516021|"     The aim of the current study was to investigate the effect of a high versus a low fat meal     (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.   "
106074|NCT01897623|"     The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms     (AAA) among male patients with coronary artery disease (CAD) verified in coronary     angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases     (coronary artery disease, peripheral artery disease and carotid artery disease), so the     hypothesis is that AAA should be more common among these CAD patients, thus making screening     of these patients (for AAA) more cost-efficient.      Study will be carried out as a multi-center prospective screening study. Data will be     collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere     University Hospital. Data consists of 200 consecutive coronary angiography patients in each     hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be     recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with     previously known AAA will be excluded from the study.   "
106075|NCT01897610|"     Immuncell-LC in aspects of therapeutic efficacy and safety when administered with Nexavar     to advanced Hepatocellular carcinoma patients when compared with the control group who did     not receive administration of the drug.   "
106076|NCT01897597|"     The purpose of this trial is to investigate the relative bioavailability of a BI 144807     tablet formulation compared to the oral solution formulation after single dose administration     (intermediate and high dose) under fasted conditions. Further objectives are to assess     whether and to what extent food affects single dose pharmacokinetics of BI 144807     administered as tablet, and to compare the relative bioavailability of two different tablet     formulations.   "
106077|NCT01897584|"     Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial     oxygenation and respiratory mechanics   "
106078|NCT01897571|"     This is a multicenter, open-label, Phase 1/2 study that is being conducted in two parts. The     Phase 1 part (closed to accrual as of January 25, 2016) is comprised of dose escalation and     expansion parts to establish the MTD and/or the recommended Phase 2 dose (RP2D) when     tazemetostat is given BID (twice daily) orally on a continuous basis. Additionally, in     separate cohorts in Phase 1, the effect of food on the bioavailability of tazemetostat as     well as the drug-drug interaction (DDI) potential of tazemetostat are being evaluated. The     Phase 2 part was initiated once the MTD and /or RP2D was established. Phase 2 enrolls     subjects with DLBCL (Cohorts 1-3 and 6) and FL (Cohorts 4 and 5) for the determination of     efficacy and safety of tazemetostat monotherapy (Cohorts 1-5) and of tazemetostat in     combination with prednisolone (Cohort 6) with placement determined by centrally confirmed     histology, cell of origin (COO), and EZH2 mutation status.   "
106079|NCT01897558|"     Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw     (active fixation) for initial fixation in the patient´s heart. Both types of electrodes     provide similar results in a long-term follow-up and the use of one or the other electrode     type in many instances is mainly based on the implanter´s preference. The PACMAN-trial     investigates whether the two lead types are associated with different amounts of myocardial     micro-damage during implantation.   "
106080|NCT01897545|"     The purpose of this study is the comparative evaluation of systolic blood pressure (SBP)     lowering, atrial fibrillation (AF) recurrence and clinical data in patients with     paroxysmal/persistent AF and resistant/non-resistant hypertension, undergoing AF ablation     alone or combined with percutaneous renal denervation.   "
106081|NCT01897532|"     The aim of the study is to investigate the longterm impact on cardiovascular morbidity,     mortality and renal function of treatment with linagliptin in a selected population of     patients with T2DM and to compare outcomes against placebo, on a background of standard of     care.   "
106082|NCT01897519|"     This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk     major surgery.   "
106083|NCT01897506|"     Our central hypothesis is that dietary limitations introduced by food allergy will contribute     to increased food insecurity in households with food allergic children when compared to food     insecure households without food allergic children.   "
106084|NCT01897493|"     The main purpose of this study is to determine how much digoxin gets into the blood stream     and how long it takes the body to get rid of it when given with the study drug evacetrapib.     This study will also look at the effect of evacetrapib on the removal of digoxin from the     body by the kidneys. Information about any side effects that may occur will be collected.     This study will last approximately 33 days for each participant, not including screening.   "
106085|NCT01897480|"     The primary purpose of this study is to compare the efficacy of the study drug LY2875358,     given together with erlotinib, against erlotinib, alone. Participants will have Non-Small     Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been     treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone,     for approximately 8 weeks. Participants with radiographic disease control at the end of the     erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib     or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over     to the combination treatment at the time of progression.   "
106109|NCT01897168|"     The primary purpose of this study is to determine the effects of early diet on bone health.   "
106110|NCT01897155|"     The purpose of this randomized clinical trial is to evaluate the effect of acute arterial     hypertension maintained during surgery on morphine's requirements in patients undergoing     laparoscopic cholecystectomy   "
106096|NCT01897337|"     PONV (Postoperative nausea and vomiting) is one of most common complications after general     anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile     agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as     risk factors for developing PONV. In consequence, patients undergoing laparoscopic     gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl     based IV-PCA. And it also causes PONV.      So, we should prevent PONV in these patients by using multimodal or combination therapy.      Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea     and vomiting. Many studies using aprepitant to prevent PONV are in progress.      In this study, we investigate the effect of combining aprepitant with ondansetron in     high-risk patients for PONV.   "
106097|NCT01897324|"     in this study, we are trying to monitor the effect of the addition of growth hormone on the     different down regulation protocols ( long, short, antagonist and microflare). The outcome     will be primarily assessed by the clinical pregnancy rates.   "
106086|NCT01897467|"     Losses of muscular fitness/balance are common occurrences with aging that can lead to an     increased fall-risk. The accelerated bone loss that may accompany menopause makes some women     even more at-risk for serious consequences related to falling. Interventions to reduce     fall-risk have been conducted in an attempt to improve balance or muscular fitness, but often     these interventions require monotonous exercises that don't arouse enough long-term interest     to elicit the improvements. In other words, while the intervention may be beneficial,     participants quit before they can realize any gains.      Currently, there is little research that uses novel technology-based programs to promote     balance exercises among middle-aged women. The Wii Fit system includes various strength and     balance exercises integrated into games intended to have the participant have fun and retain     interest, while also improving fitness. By using such a program, women could potentially     improve their balance and decrease their fall risk in a way that is fun and exciting.      The purpose of this study is to investigate the effect of a Wii Fit based exercise program on     balance/muscular fitness/markers of bone health in women between the ages of 45-60 with low     bone mass. Volunteers who have moderately low bone levels (n = 28) will be randomly assigned     to either the Wii Fit exercise intervention or a normally active control. Balance ability,     muscular fitness, body composition, physical activity levels and markers of bone health will     be assessed before and after the intervention.      Each participant in the intervention will be provided a pre-programmed Wii Fit console and     balance board to use at home. The intervention will consist of a 12-week program that they     perform 30 minutes a day 3 days a week. The exercises include 10 minutes of Yoga poses and     strength exercises and then 20 minutes of balance games such as soccer heading, ski slalom     and table tilt.      At the 6 week point and the conclusion of the intervention, participants will come to the lab     for testing on the same tests done initially.      The overall goal of this study is to gauge the efficacy of this intervention to improve     balance, fitness, and bone health in at-risk women. This project is important because it     offers an exciting, fun, and motivating way to impact fall-risk before clinical symptoms     develop. Overall, this intervention could significantly reduce healthcare dollars spent on     fall-related outcomes, as well as reduce fall-related mortality.   "
106087|NCT01897454|"     This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and     radiation therapy before surgery works in treating patients with pancreatic cancer that has     not spread to other places in the body and can be removed by surgery. Drugs used in     chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride,     oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil,     irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy     and gemcitabine hydrochloride with radiation therapy before surgery may make the tumor     smaller and reduce the amount of normal tissue that needs to be removed.   "
106088|NCT01897441|"     This randomized pilot clinical trial studies chemotherapy before surgery and tissue sample     collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as     doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells o     grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide, paclitaxel and     trastuzumab may kill more tumor cells. Collecting and storing samples of tissue from patients     with breast cancer to study in the laboratory may help doctors learn more about how well     patients will respond to treatment.   "
106089|NCT01897428|"     To compare the relative bioavailability and pharmacokinetic characteristics of a newly     developed bepotastine formulation, bepotastine salicylate, with a conventional formulation,     bepotastine besilate, in healthy subjects with a single dose, randomized, open-label,     2-sequence -2period crossover study.   "
106090|NCT01897415|"     This is a Phase I safety and feasibility study. Subjects will be enrolled serially. For     subject safety, the preceding subject must have completed one cycle of therapy (28 days)     before the next subject can be treated. Subjects will be treated with i.v. administration of     1 to 3e8 per meter squared RNA CAR T cells three times weekly (M-W-F) for three weeks.   "
106091|NCT01897402|"     The purpose of this study is to evaluate the production of antibodies to a new conjugate     vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the     production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135)     polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate     the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The     hypothesis is that the test vaccine is comparable to the licensed active control vaccine.   "
106092|NCT01897389|"     The purpose of this study is to evaluate the relative bioavailability of 4 new formulations     of abiraterone acetate compared to the current commercial formulation.   "
106093|NCT01897376|"     The purpose of this study is to determine if there is a difference between Pfannenstiel and     midline vertical skin incision at time of cesarean section in preventing wound complications     in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used     skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon     admission and randomize them to one of the above incision types in the operating room. The     investigators will follow them for 6 weeks post-op to evaluate for wound complications. There     is minimal risk to the participant as both incision types are acceptable in current     obstetrical practice. There is no direct benefit to the patient.      Currently, there is no level I evidence to support either Pfannenstiel or midline vertical     skin incision in the prevention of wound complications in the obese patient undergoing     cesarean section. Therefore, current practice is for the surgeon to make the decision based     on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean     section is a very common procedure, with a national rate of 32% of all live births in 2007.     Not only does obesity increase the expectant mother's risk of a cesarean section, it is also     a well recognized risk factor for wound complication. The cesarean wound complication rate in     the morbidly obese population at the University Of Texas at Houston - Memorial Hermann     Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight     population, 28% compared to 1.4%. Results from this study could be extrapolated in the future     to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use,     shorter hospital stay, and overall lower health care costs.   "
106094|NCT01897363|"     This project will study whether infants with Prader-Willi Syndrome experience low blood     sugars after short periods of fasting. This study will also evaluate metabolic markers in the     blood to determine if infants with Prader-Willi Syndrome process energy differently than     other children during fasting.   "
106111|NCT01897142|"     The purpose of this study is to determine what the study drug does to the body, what the body     does to the study drug, and if the study drug is safe and well tolerated when given to adult     healthy volunteers.   "
108621|NCT01864252|"     The purpose of this study is to determine whether Glyceryl Trinitrate (GTN) reduces injury to     the heart during heart-lung bypass surgery in combination with the newer technique of remote     ischaemic preconditioning (RIPC).   "
106100|NCT01897285|"     AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a     waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone     adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a     non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in     2012. A new source of silicone adhesive is now under assessment for this product. This     Healthy Volunteer Wear test will form part of the Design Validation for this change in     supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can     coat the silicone adhesive to provide comparable adhesive dressing performance in terms of     wear time, ease of use and with a similar safety profile in relation to the skin.   "
106101|NCT01897272|"     This research study is for patients who are schedule to have carpal tunnel release surgery.     The investigators have developed this study in order to determine if post-operative splinting     is effective in improvement of patient outcomes after this surgical procedure. The study is     being conducted under the direction of Huey Tien, MD. The purpose of this study is to     determine if post-operative splinting is effective in improving patient outcomes after having     short-incision carpal tunnel release. The investigators will randomize each patient into     group 1, splinting after surgery or group 2 no splinting after surgery. Each group will have     the same outcome measurements done to determine the best outcome of the two groups.   "
106102|NCT01897259|"     This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be     randomized into one of 4 possible treatments. The purpose is to individually examine the     efficacy of each treatment, and determine if one treatment method is more effective than     another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs     (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.   "
106103|NCT01897246|"     The investigators are comparing post-operative patient-rated functional outcome between     patients who undergo corrective osteotomy for extra-articular malunited distal radius     fractures with and without computer assisted pre-operative planning and virtual osteotomy.   "
106104|NCT01897233|"     This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the     pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in     subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic     fibrosis transmembrane conductance regulator (CFTR) gene.   "
106105|NCT01897220|"     The aim of the study is to analyze the present use of antithrombotic therapy on a large     cohort of consecutive cardiacs undergoing non-cardiac surgery. If even and for how long the     medication was discontinued, if any other antithrombotic therapy was used in the     perioperative period and prevalence of perioperative complications - especially ischemic or     bleeding. These complications will be correlated with the pattern of antithrombotic therapy     administration. Working hypothesis is to obtain a large database of unselected cohort of     consecutive patients for mapping of this practically important, but in the evidence-based     medicine, still neglected problem.   "
106106|NCT01897207|"     The main aim of this trial is to assess the response rate, the feasibility and toxicity of     the treatment with antigen loaded Dendritic Cell Vaccination in Prostate Cancer patients.     Furthermore we want to investigate biological responses by measuring markers of in-vivo and     ex-vivo immunomodulation.   "
106107|NCT01897194|"     Despite its clinical significance, the pathophysiology of coma is still under investigation     and the physiology of emergence from coma remains a mystery. Furthermore, predictors of     emergence from coma, despite their obvious clinical value, remain un-established. Because of     its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has been     studied as both an animal and human model of coma, and awakening from sleep has likewise been     studied as a surrogate of coma emergence. In this study, we will determine whether certain     electrographic patterns, known as spectral shifts, which have correlates in normal sleep, are     predictive of eventual awakening from coma and the time course of this emergence. To detect     spectral shifts in comatose patients, EEG monitoring must be performed for several days.     Quick, simple, and reliable EEG recording in the ICU will be enhanced by a small device that     can be easily and properly positioned on the head by hospital personnel and which lacks     cumbersome cables or receivers. Traditional EEG monitoring requires placement of up to 25     wires, which can impede efficient intensive patient care. Our hypothesis is that we can     detect a difference in spectral shifts in comatose patients who will eventually emerge from     coma as compared to comatose patients who do not wake up and that a wireless EEG patch-type     device can effectively make this distinction.   "
106108|NCT01897181|"     The purpose of this study is to evaluate the central auditory processing in patients with     bilateral sensorineural hearing loss and to observe the change of the central auditory     processing ability after using hearing aids.   "
106112|NCT01897129|"     Purpose Our study involves two hypotheses. One is that genital infection with HPV is     associated with increased risk of miscarriage and preterm birth. The second hypothesis is     that human papillomavirus can ascend from the vagina to the uterus through the cervix and     cross the placental barrier. We wish to verify these hypotheses in our studies.      This study will determine the prevalence of HPV in Danish pregnant women and examine HPV's     role in the aetiology of spontaneous abortion and preterm birth.   "
106113|NCT01897116|"     This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of BRAF     V600E+ metastatic melanoma.   "
106114|NCT01897103|"     The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers     during the perioperative period. The goal is to develop a clinically useful assessment of     platelet/coagulation activity for risk stratification that may ultimately serve as a target     for therapeutic intervention. This study will enroll 200 patients with peripheral artery     disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is     scheduled to begin enrollment in July 2013 for approximately two years.   "
106143|NCT01896700|"     Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the     treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis     tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS     to improve fatigue. It is proposed that methylphenidate may also improve imbalance and     walking deficits in MS by improving concentration and central integration, one of the primary     mechanisms thought to underlie imbalance and walking deficits in MS.   "
106115|NCT01897090|"     A 16-week randomized, pilot study to determine if an elimination diet reduces symptoms of     Crohn's disease. Sixty (60) adult patients (18-75 yrs) with a mild or moderate Crohn's     Disease Activity Index (CDAI) of 150-450, will be recruited through the GI practices at Johns     Hopkins University. Patients agree not to be on any other major treatments, with the     exception of consistent/stable doses of 5-aminosalicylate (ASA) drugs/other medications     during the course of the study and will obtain their physician's permission.They will be     divided into a treatment and standard diet group: thirty (30) patients will be on the     Crohn's Disease Diet (primarily an anti-inflammatory diet that is an elimination diet -     gluten-free, casein-free based with limited carbohydrate) and thirty (30) patients will be     given the Dietary Guideline recommendations and similar dietary counseling attention. To     assess the clinical efficacy and tolerance of the trial population, patients will be     monitored by two office visits (at 0 and 12 weeks) by visits with the Clinical Research Unit     (CRU) registered dietitians (RDs) at 0, 6, 12, and 16 weeks (4 weeks after the end of the     study) for blood and dietary data collection. Clinical endpoints will be Crohn's disease     Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe =     450+), C-Reactive Protein (CRP) values (0-0.8 mg/L), sedimentation rate /(male: 15-20 mm/hr,     female: 20-30 mm/hr)/, possibly interleukin-6(/normal value: <10pg/ml)/, Overall Quality of     Life (QOL) through the Inflammatory Bowel Disease Questionnaire (IBDQ), Dudley IBD Symptom     Questionnaire (DISQ) surveys, and Brown's Gastrointestinal Quality of Life (QOL)     Questionnaire, and health care costs measured by a health care cost questionnaire.   "
106116|NCT01897077|"     The purpose of this study is to determine if a new method of administration of peanut     sublingual immunotherapy, a dissolving peanut film, is effective.   "
106117|NCT01897064|"     The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and     neurocognitive functioning including memory, attention, the ability to plan activities, and     learn new information. Participants will be assigned by chance to receive regular care or     exercise sessions in addition to regular care. This study will allow determining the     potential positive influence of AE on cognitive and daily functioning in individuals with     schizophrenia.   "
106118|NCT01897051|"     To reduce portal pressure, the only recommended medication is nonselective beta     blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response     rate and compliance.      Recent literature has supported the role of bacterial translocation as a mediator of     splanchnic vasodilatation and portal hypertension. This stimulates the release of     pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more     pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut     decontamination with Rifaximin can induce inhibition of bacterial translocation and     associated worsening of portal hypertension. The investigators hypothesized that Rifaximin     plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal     varices.   "
106119|NCT01897038|"     This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and     dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in     participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive     onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3     will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg     orally daily or twice daily. Anticipated time on study treatment is until disease progression     or unacceptable toxicity occurs.   "
106120|NCT01897025|"     Stroke is the most common cause of adult disability. Current treatments for functional loss     of the upper extremity post-stroke remain limited in efficacy, particularly for those with     moderate to severe impairment.      Previous studies have demonstrated the efficacy of transcranial direct current stimulation     (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is     effective to enhance motor recovery, with activation of neural pathways similar to that of     motor execution. This treatment is accessible to more severely impaired stroke survivors. Our     previous studies have demonstrated feasibility and efficacy of motor imagery-based brain     computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is     detected by surface EEG and translated to execution of the target movement with the aid of an     arm robot (MIT-Manus).      In this study, we investigate the feasibility of combining robot-assisted MI-BCI training,     with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper     extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor     function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI.     Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the     cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic     stimulation (TMS).      We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI)     vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS     each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each     session. Primary outcome will be functional ability measured by upper extremity component of     the Fugl-Meyer Assessment. Secondary outcome measures will be the Box & Block Test, Modified     Ashworth Score (measuring spasticity), grip strength and measures of brain activity including     transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures     including functional MRI and diffusion tensor imaging (DTI).      This study will be important to develop a new and effective treatment (tDCS-BCI) for     post-stroke motor impairment.   "
106121|NCT01897012|"     This phase I trial studies the side effects and best dose of alisertib and romidepsin in     treating patients with B-cell or T-cell lymphomas that have returned after a period of     improvement (relapsed) or have not responded to treatment (refractory). Alisertib may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used     in chemotherapy, such as romidepsin, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving alisertib and romidepsin may be a better treatment for relapsed or     refractory B-cell or T-cell lymphomas.   "
106123|NCT01896986|"     In 2007-2009 the investigators conducted a study to determine the immunogenicity response to     HPV vaccine in special risk patients known to be at increased risk of abnormal cervical     cytology. The serological response to the vaccine was measured 1 month post the third and     final dose (n=70) finding a robust response overall.      The aim of this follow-on study is to provide data on the long-term protection offered by the     HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and the     impact on cervical cytology abnormalities in these special risk groups is important.      The study results will help inform national immunisation program recommendations re- booster     HPV vaccine doses.   "
106124|NCT01896973|"     The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy     device. The purpose of this study is to assess and monitor the performance of the Vortx Rx     for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.   "
106144|NCT01896687|"     This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back     pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.   "
106125|NCT01896960|"     Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery.     Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is     one cause of this hypotension. The higher the spread of the blockade will result in a higher     incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread     within the intrathecal space before it will be taken up by the nerve roots. The time that a     patient remains in one position after medication injection will affect the spread of the     resultant anesthetic block. A patient who is left sitting for a longer period of time after     injection of hyperbaric medication will have a lower level of block than someone who is     placed supine immediately. In this study, the investigators wish to use up down sequential     analysis to determine the time period a patient should remain seated after intrathecal     injection of hyperbaric bupivacaine and fentanyl that will result in a 50% rate of     hypotension.   "
106126|NCT01896947|"     The purpose of this study is to evaluate the diagnostic performance of three Tesla magnetic     resonance imaging (3T MRI) compared to magnetic resonance arthrogram (MR arthrogram) in     diagnosing superior labrum anterior posterior (SLAP) lesions. We hypothesize that 3T MRI will     have non-inferior sensitivity compared to MR arthrogram in diagnosing SLAP lesions utilizing     arthroscopy as our gold standard test. To evaluate our hypothesis, the investigators will     include patients suspected to have a SLAP lesion on history and physical examination by a     fellowship trained orthopaedic surgery. Patients will be offered advanced imaging (both 3T     MRI and MR arthrogram) as well as arthroscopy for definitive diagnosis and treatment after     consent is obtained. A fellowship trained musculoskeletal radiologist will perform and     interpret the magnetic resonance tests while the arthroscopy will be performed by orthopaedic     surgeons. The diagnostic characteristics of each imaging modality, including sensitivity,     specificity, negative predictive value, and positive predictive value, will be compared to     each other.   "
106127|NCT01896934|"     The long-term goal of this line of research is to determine if decreased vascular reactivity     and frontal hypoperfusion is associated with poor response antidepressants. Such perfusion     deficits could contribute to antidepressant nonresponse as they would hinder improvements in     dorsal system metabolism seen with antidepressant treatment. The objective of the current     proposal is to determine if decreased vascular reactivity and frontal hypoperfusion in     depressed elders predicts and persists with antidepressant nonremission. The investigators     will pursue the primary aim testing the hypothesis that decreased reactivity and     hypoperfusion, specifically in the dorsolateral prefrontal cortex and dorsal anterior     cingulate cortex, predict antidepressant nonremission. The investigators will enroll 40     depressed elders who will complete clinical, cognitive, and MRI assessments before and after     a 12-week open-label antidepressant trial of sertraline.   "
106128|NCT01896921|"     This clinical study proposes to evaluate the combination of maraviroc with an integrase     strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced     patients to document the efficacy, safety, and tolerability of this combination in order to     provide clinicians with a treatment regimen that minimizes the risk of metabolic     complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART     regimen which lessens the risk of metabolic complications could improve long-term adherence     and reduce the risk of certain co-morbidities associated with long-term ART use. If this new     combination is found to be as efficacious as the standard regimen with enhanced tolerability     and improved metabolic effects, there is great potential for altering the current practice of     HIV medicine.   "
106129|NCT01896908|"     Although half of the patients with HF has normal ejection fraction or slightly altered     (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the     pathophysiology of HF-PEF is still poorly understood.      Sodium restriction is the most common measure of self-care oriented to HF patients for     management of congestive episodes. The role of this orientation in the treatment of patients     with preserved ejection fraction, however, is still unclear. The evaluation of the effects of     sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF can     promote a better understanding of the pathophysiological progression of this complex     syndrome.   "
106130|NCT01896895|"     This phase 3 study will serve to collect efficacy and safety data of two different doses of     NT 201 in subjects suffering from Bilateral Blephorasm (BEB) who are BTX treatment-naïve.      In this study, BTX treatment-naïve subjects are defined as those who have not received BTX     treatment within the last 12 months for the treatment of BEB. This definition aims to avoid     bias by comparison of treatment effects in the subject's assessments. Furthermore, this study     will substantiate the existing efficacy and safety database for the indication BEB.   "
107444|NCT01879722|"     The purpose of this study is to characterize the safety and tolerability of TAK-063 when     administered as multiple oral doses at escalating dose levels in participants with stable     schizophrenia and in healthy Japanese participants.   "
106131|NCT01896882|"     Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased     risk for cardiovascular diseases. These complications are associated with end stage renal     disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the     effects of nutritional counseling restricting dietary sodium and its relation to clinical and     diet factors, nutritional knowledge and quality of life in hemodialysis patients.   "
106132|NCT01896869|"     This study will enroll patients who have metastatic pancreatic cancer with stable disease on     FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between     patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to     receive FOLFIRINOX.      Funding Source - FDA OOPD   "
106133|NCT01896856|"     This is a phase I/randomized phase II study of the combination of SGI-110 and previously     treated metastatic colorectal cancer patients. This study will be conducted in two     components. First, patients will be enrolled in a phase I study of SGI-110 combined with     irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined,     patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and     irinotecan versus the standard of care regorafenib or TAS-102.   "
106145|NCT01896674|"     The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their     role in the identification of coronary artery disease and abnormalities in cardiac     structures.   "
124382|NCT01657656|"     Hypothesis      That improving vitamin D status among TB patients will speed the pace of bacteriological     cure, and will enhance immune responses to TB infection   "
106134|NCT01896843|"     Background:      - A small brain protein called the metabotropic glutamate receptor subtype 5 (mGluR5) may     affect several brain diseases such as autism and depression. Researchers will use 2     radioactive chemicals ([11C]SP203 and [11C]FPEB) and a research drug (STX107) that can attach     to the receptor, to figure out the best way to use positron emission tomography (PET) to see     the mGluR5 receptor. They will use scans to monitor where the radioactivity goes.      Objectives:      - To find the best way to image the mGluR5 receptor in the brain.      Eligibility:      - Healthy volunteers ages 18 to 55.      Design:        -  All participants will be screened with a medical exam at visit 1. In later visits, they          may have a PET scan, when two small tubes are placed under the skin and they lie down in          a scanner. They may have an MRI scan, when they lie down in a scanner.        -  Part 1 participants will have 2 more visits. They will have a PET brain scan using          [11C]FPEB and will have blood drawn. Then they will have an MRI brain scan.        -  Part 2 participants will have 1 more visit, with a whole body PET scan using [11C]FPEB          and blood drawn.        -  Part 3 participants will have 4 more visits, including 1 overnight stay at a hospital.          Over all the visits, they will have 4 PET scans and 1 MRI brain scan. They will receive          the research drug and injections of both chemicals. Blood will be drawn during the          scans.   "
106135|NCT01896830|"     The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese     population.      Primary objectives:        -  To describe the safety profile of all subjects who receive at least 1 injection        -  To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples          obtained on Days 0, 14, 30, and 60.   "
106136|NCT01896791|"     Climacteric or Menopausal Transition is defined as the time period where there is a change to     non-reproductive reproductive life, with extension of variable length. During this period,     and after the establishment of Menopause and non-functioning ovarian, the appearance of     various symptoms that express the depletion of ovarian follicles is common; among these     symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In     addition to hormonal therapy, other medications have been employed in an attempt to improve     these symptoms; although they present better results than placebo, yet have little clinical     impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of     alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale     for studying the effect of this technique in this context is its possible autonomic     modulatory effect. What reinforces the choice of this technique is the fact that it     demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease,     among others. Transcranial direct current stimulation (tDCS) is a renewed method of     non-invasive brain modulation. It is based on a transcranial application of weak direct     currents in a non-invasive, simple and painless manner. Its use in the treatment of vasomotor     symptoms has not been studied. The objective of this study is to evaluate the improvement of     vasomotor symptoms in postmenopausal women, after application of tDCS, and compare them to a     control group. This Randomized Clinical Trial will be held in female postmenopausal patients,     followed in the outpatient Menopause Clinic of Obstetrics and Gynecology Service, Hospital de     Clinicas de Porto Alegre. From these results, it is expected to present a new therapeutic     option in the treatment of vasomotor symptoms.   "
106137|NCT01896778|"     This randomized pilot clinical trial studies body warming in improving blood flow and oxygen     delivery to tumors in patients with cancer. Heating tumor cells to several degrees above     normal body temperature may kill tumor cells.   "
106138|NCT01896765|"     It is unknown, if a modern prevention program, including intense nurse-coordinated education     sessions, regular telephone contacts and a telephone hotline for 12 months, significantly     reduces cardiovascular risk factors, clinical events and quality of life in myocardial     infarction patients compared to usual care. Furthermore, actually no data on the additional     effects and the feasibility of longterm telemetric care of cardiovascular risk factors exist.      The primary hypothesis to be tested is that an intensive longterm prevention program compared     to the standard of medical care, will achieve better risk factor control and consecutively     less clinical adverse events in patients after myocardial infarctions. A nurse-coordinated     program and telemetric prevention will be analyzed.   "
106160|NCT01896479|"     The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a     60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will     test if the lower dose results in similar progression free survival (PFS) and overall     response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events     found in previous clinical trials of 140 mg.   "
106181|NCT01896206|"     This study will compare accuracy of a newly developed monitor for continuous non-invasive     blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria)     that provides beat-to-beat BP readings with two of the current and more commonly used     intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive     arterial line (IBP).   "
106182|NCT01896193|"     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus     ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1     (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.   "
106139|NCT01896752|"     High-dose methotrexate therapy (HDMTX) is an important part of treatment of childhood acute     lymphoblastic leukemia (ALL). HDMTX would be improved substantially if it were possible to     predict the clearance of MTX for each patient and use this to tailor an individualized dosing     of the drug. However, only about 3.7, 0.2, and 2% of the inter-individual variation in MTX     clearance is explained by age, gender and ancestry, respectively. Genetic variation seems to     explain about 10% of this difference, and SNPs in genes encoding transporter proteins (e.g.     organic anion transporter 1B1 (OATP1B1) and reduced folate carrier (RFC)) are suggested to     have a particular large impact. A serious limitation to the applicability of SNPs in     prediction of MTX pharmacokinetics, however, is the substantial intra-individual variation in     MTX clearance.      The intra-individual variation in MTX clearance is related to renal function but a large     amount of a HDMTX dose also enters the liver, where it is metabolized to 7-hydroxy MTX and     probably also undergoes enterohepatic circulation. Thus, the aim of this study is to     determine the role of the liver and renal function in MTX pharmacokinetics, and evaluate the     predictive potential of pharmacogenetic (e.g. the rfc SNP) and pharmacokinetic parameters of     MTX elimination during HDMTX.   "
106146|NCT01896661|"     Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their     control could reduce the burden of heart disease across populations. There are several drugs     to control hypertension, but the only consistently beneficial treatment to reduce apneas is     continuous positive airway pressure. The demonstration that one drug could improve sleep     apnea and hypertension would support a novel approach in the treatment of both diseases. The     role of fluid retention in sleep apnea is known for several decades. The role of diuretics is     well established in hypertension but was never appropriately tested in sleep apnea. Besides     to test the efficacy of these drugs, this study will help to understand the mechanisms that     link hypertension and sleep apnea and its treatment.   "
106147|NCT01896648|"     Type 2 diabetes mellitus is becoming an increasingly problem for public health and it is     related with various complications such as sexual problems. The prevalence of erectile     dysfunction has been widely studied in men as a complication of diabetes; the prevalence of     sexual dysfunction in women, instead, has not been well investigated. The aim of this study     is to evaluate the prevalence of sexual dysfunction in type 2 diabetic women using     international validated questionnaires.   "
106148|NCT01896635|"     The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is     safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting     a randomised controlled trial   "
106149|NCT01896622|"     Background:      - People who have the human immunodeficiency virus (HIV) often take several medications to     control their disease. They may also need to take medicine to prevent blood clots. Taking     both kinds of medicine together can cause bleeding or other problems. But this might not     happen if the medications are taken at different times. Researchers will study two particular     HIV drugs (ritonavir and cobicistat) and how they interact with blood clot medications.      Objectives:      -To understand how HIV medicine and blood clot medicine interact, so doctors can choose what     to prescribe for people who take both.      Eligibility:      - Healthy adults between 18 and 70 years old who are not on any medications.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. Urine samples will be collected from participants who might become          pregnant.        -  Participants will visit the National Institutes of Health 7 times after the screening          visit. Three visits will last about 12 hours. The other 4 will last about 1 hour.        -  Participants will take a daily dose of either study medication for 22 days. They will          keep a diary of medicine they take and any side effects.        -  Treatment will be monitored with blood tests over about 2 months.        -  When the study of one drug is completed, the next drug study will begin with a different          group of participants.   "
106161|NCT01896466|"     The purpose of this study is twofold:        1. Establish baseline measures of gait performance in healthy young and older adults, and          older adults with a history of falls.        2. Investigate the effects of gait and balance training with and without cranial nerve          noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older          adults.      For the second purpose, the study will incorporate a placebo-controlled design to evaluate     the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups     will perform gait and postural balance training (outlined in more detail below) but will     differ in the stimulation level of the PoNS device. The investigators will use the results of     this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention     program.   "
106150|NCT01896609|"     A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing the     efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® , Ribavirin ,     Nitazoxanide and Alfacalcidol (Bon-One ® ) versus Triple therapy regimen (Reiferon Retard® ,     Ribavirin and Nitazoxanide) versus the standard of care regimen(Reiferon Retard® and     Ribavirin) in the treatment of Naïve chronic hepatitis C among the Egyptian population.     Effectiveness will be evaluated based on Sustained Virological Response (SVR) .      PRIMARY OBJECTIVE(S): The primary objectives of this trial are as follows:        -  To compare the efficacy of the three treatment arms in naïve Chronic Hepatitis C Virus          (HCV) genotype 4 patients by evaluating the sustained virological response ( SVR) at          week 60 ( 3 months after end of treatment period)        -  Identify optimum treatment protocol for HCV genotype 4 in respect to used combination of          medications        -  Whether adding vitamin D, a potent immunomodulator, could improve viral response.      STUDY DESIGN: This is a phase IV, single center, open labeled, randomized (1:1:1) controlled     study.      NUMBER OF EVALUABLE SUBJECTS: 300 NUMBER OF CENTER/S: 1 Country:Egypt DURATION OF THE STUDY:     94 weeks TREATMENT: randomized 1:1:1 ratio into 3 Arms SUBJECT POPULATION: male or female     subjects assessed by BMI less than 35, between the ages of 20 and 50 years. Subjects have to     be diagnosed as Naïve Chronic Hepatitis C genotype 4 patients with compensated liver disease     assessed by hematological and biochemical tests.      - DURATION OF THE STUDY: 94 weeks as follows:      Estimated Enrollment Duration: 16 weeks Collection of last Case Report Form (CRF) : 2 weeks     from Last patient out. Queries Resolution: 4 weeks from Collection of last CRF. Database lock     planned date: 2 weeks from Quires resolution. Final Study Report: 8 weeks from Database lock.     Estimated duration of subject participation: 62 weeks as follows;        -  Screening period per subject = 2 weeks        -  Treatment phase per subject = 48 weeks        -  Follow-up phase per subject = 12 weeks      N.B : Each patient will receive medications for Maximum 48 weeks if his/her Polymerase Chain     Reaction (PCR) -ve at weeks 12 and 24 , and if his/her PCR +ve at week 12 or week 24 the     treatment will be stopped .   "
106151|NCT01896596|"     In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age,     which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus     influenzae type b (Hib). Infants also routinely receive a meningococcal group C vaccine     (MenC) at 3 and 4 months and a 13-valent pneumococcal vaccine (Prevenar13) at 2 and 4 months     of age. This study aims to offer infants a 6-in-1 vaccine (Infanrix-Hexa)that also helps     protect against hepatitis B alongside the other routine vaccinations in the UK infant     immunisation schedule and assess their immune responses to the different vaccines. Hepatitis     B virus infects the liver and usually affects adults, but children can be infected through     close contact with carriers of the virus. Children with hepatitis B infection may not have     symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. Many     other countries already use Infanrix-Hexa and this study is being undertaken to help decide     whether the UK can do the same. Babies taking part in this study will receive Infanrix-Hexa     instead of Pediacel. All other vaccines given will be the same as in the routine schedule but     will include one MenC vaccine instead of 2 doses because the UK infant immunisation schedule     is soon going to change so that all babies will receive only one MenC vaccine at 3 months of     age.      There are currently several licensed MenC vaccines that can be given to babies. In order to     check whether there are differences in protection, babies taking part will randomly receive     one of 3 MenC-containing vaccines: NeisVacC, Menjugate or Menitorix. Studies have already     shown that one dose of Neis-Vac or Menjugate given to babies at 3 months provides similar     protection against MenC infection as two doses given at 3 and 4 months. Menitorix protects     against both Hib and MenC, so babies in the group receiving MenitorixTM will have an extra     dose of Hib which is also included in Infanrix-Hexa but might have a lower antibody response     to MenC compared to the other two MenC vaccines, although all infants should be     well-protected after their 12-month booster vaccinations, which also contain Menitorix.   "
106152|NCT01896583|"     This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4     weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over     the 4-week treatment period.   "
106170|NCT01896349|"     The purpose of this study is to determine whether combination of antidepressant drugs plus     interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant     depression.   "
106154|NCT01896557|"     Previous reports have shown a possible drug interaction between clopidogrel and proton pump     inhibitors (PPI´s), which could result in increased number of adverse cardiovascular events     among patients on dual antiplatelet therapy(DAPT). Because of this, ranitidin has been     proposed as an alternative drug to PPI´s for prophylaxis of gastrointestinal bleeding in     patients who need DAPT. The study´s aim is to test the hypothesis that ranitidin doesn´t have     any influence on clopidogrel pharmacodynamic.   "
106155|NCT01896544|"     Sepsis in a clinical entity that occurs in patients with serious infections. Though the     severity of illness may vary, every year, approximately 1.6 million Americans are treated for     sepsis. Even with timely interventions, anywhere from 16% to >80% of patients with sepsis     will not survive. Immune dysfunction is thought to play a critical role in the ability for     infections to evolve into sepsis and to eventually lead to death. Recently, vitamin D has     been identified as a key regulator of the immune system. While it remains unclear whether     optimizing vitamin D status may improve outcomes in sepsis, little is known about the effects     of vitamin D supplementation in patients with severe infections. As such, our goal is to     study whether high doses of cholecalciferol (vitamin D3) can improve vitamin D status and     boost certain aspects of the immune system in patients with sepsis.   "
106156|NCT01896531|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy of GDC-0068 in combination with oxaliplatin, 5-fluorouracil, and leucovorin     (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic     gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive     either GDC-0068 or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination     with mFOLFOX6 on Day 1 of each cycle. Anticipated time on study treatment is until disease     progression or unacceptable toxicity occurs (up to approximately 2 years).   "
106157|NCT01896518|"     The overall aim of the current study is to determine if the use of nicotine containing     products by caregivers who smoke and who are not interested in quitting, is effective in     reducing children's secondhand smoke exposure.   "
106158|NCT01896505|"     The purpose of this research study is to find out more information such as: to determine the     effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets, to     compare PK of capsules and tablets, to assess the effects of KPT-330 on cellular morphology     and biomarker changes on sarcoma biopsy specimens (in patients who can safely undergo     biopsy).   "
106159|NCT01896492|"     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting     approximately 6-10% of women of reproductive age. Anovulation, infertility and     hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .      Clomiphene citrate remains the standard drug for induction or augmentation of ovulation.     However, it is not equally effective in all situations, and therefore it may require     additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested     as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of     insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for     the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in     PCOS .   "
106162|NCT01896453|"     The purpose of this study is to evaluate the efficacy of brain and peripheral electrical     stimulation on chronic non-specific low back pain patients.   "
106164|NCT01896427|"     In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these     impacted third molars may provide special complication as pain, swelling, and trismus. In     previous studies, some techniques as sutureless flap closure, modified flap designing,     antibiotic usage, and injection of corticosteroids were presented. These methods are reducing     post operative complications to moderate level. In this study, pain, swelling, trismus,     general patients' satisfaction, and associated quality of life after the surgical removal of     third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does     not need excessive time, effort, and equipments and it will be injected in numbness area into     medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting     non-corticosteroid methods. To achieve this aim, 75 non pregnant participants have single     impacted mandibular third molar in healthy and without pericoronitis manner, after provision     of written informed consent will be entered to the study. During the study, unwilling     participants to continue the study and those with abnormality of wound healing process will     be excluded. The included participants will be assigned into three 25-people groups. The     surgeries were done by 3 same instructed experienced oral and maxillofacial residents. After     the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality     of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week     period of time. The comparison was done between these three groups.   "
106165|NCT01896414|"     The metabolic syndrome raises the risk of heart disease and is currently at epidemic     proportions in the U.S. It consists of 3 of the following components: central obesity, high     triglycerides, low HDL, abnormal blood pressure and impaired fasting glucose levels. Previous     studies have suggested that omega-3 fish oil may influence some of these components but the     mechanisms involved are not well understood. Therefore, this proposal will investigate how     omega-3 fish oils affect inflammation, lipids and fat breakdown by comparing it to placebo.     Favorable outcomes from this study could translate into a new approach to improve heart     disease risk in men and women with the metabolic syndrome.   "
106166|NCT01896401|"     The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access     sites for quick hemostasis and ambulation in patients who have undergone large bore     endovascular catheterization procedures.      The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the     study population.   "
106167|NCT01896388|"     Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the     pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the     NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD.     The purpose of this study is to confirm whether ifenprodil tartrate is effective in the     treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these     patients, this study contributes to the development of novel therapeutic drugs for PTSD.   "
106168|NCT01896375|"     Present study is conducted on Gutkha and Pan Masala users to find out the impact of ban on     them. It will also try to find out awareness about ban and source of information for the     same. Availability of Gutkha and Pan Masala in post ban period will also be assessed.   "
106174|NCT01896297|"     The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe     renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by     Cockcroft-Gault formula.      The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with     severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and     simulation.   "
106175|NCT01896284|"     Patients with neovascular age-related macular degeneration who do not respond to usual     treatment with conventional medications may respond to a new drug of the same class which is     designed to block a larger fraction of proangiogenic factors.   "
106176|NCT01896271|"     In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic     radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky     progressive disease, but also to provide antigen presentation and immune stimulation which is     expected to act synergistically when immediately followed by the non-specific immune     stimulation provided by treatment with HD IL-2 and thereby increase the response rate and     complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR     are FDA approved therapeutic cancer treatment   "
106177|NCT01896258|"     As a first step towards reform of the emergency medical service system by standardizing     triage scale to Korean Triage and Acuity Scale(KTAS), we aimed to assess the present status     of our emergency department triage systems and illustrated the present status and problems of     the Korean emergency department triage system.   "
106178|NCT01896245|"     Anesthesia induction and tracheal intubation can be performed with and without neuromuscular     blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of     NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are     similar, too.   "
106179|NCT01896232|"     The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is     not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels     by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary     hyperparathyroidism (SHPT) who require management with hemodialysis.   "
108622|NCT01864239|"     The purpose of this study is to find out whether talking to a pharmacist on the telephone can     help to support people taking medicine for a long-term condition.   "
106184|NCT01896167|"     In this study the investigators will investigate the following hypothesis        -  that hypoxia induce migraine headache and migraine aura        -  the aura phase is associated with a spreading reduction in cerebral blood flow        -  the migraine headache is associated with dilatation of intra- and extracerebral arteries        -  the migraine headache is associated with changes in brain metabolism        -  the pre-ictal stage of a migraine attack with aura is associated with specific patterns          in neural activity.   "
106185|NCT01896154|"     The aim of the study is to estimate the effect size of a 5-week consumption period of     different dietary non-digestible polysaccharides (NPS) on antibody response to influenza     vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether     these NPS may enable enhancement of immune defence and to estimate the sample size for a     confirmative trial. Furthermore the effects on faecal microbiota and its metabolites will be     investigated.   "
106186|NCT01896128|"     Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a     relatively safe agent with interesting neurochemical effects on the catecholamine system,     producing an improvement in cognitive function, particularly working memory in humans. When     combined with intensive task-related training, armodafinil may accelerate motor recovery in     chronic stroke patients.      The primary aim of this study is to determine whether administration of armodafinil during     subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor     recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by     armodafinil and, therefore, will induce an improvement in motor function and better     performances on measures of motor control.   "
106187|NCT01896115|"     The objective of the study is to compare different deep brain stimulation (DBS) settings     using the commercially approved Boston Scientific Neuromodulation Vercise system.   "
106188|NCT01896102|"     This trial will assess the efficacy and safety of autologous CD34+ hematopoietic stem cells,     transduced ex-vivo with Lenti-D lentiviral vector, for the treatment of cerebral     adrenoleukodystrophy (CALD). A subject's blood stem cells will be collected and modified     using the Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein. After     modification with the Lenti-D lentiviral vector, the cells will be transplanted back into the     subject following myeloablative conditioning.   "
106189|NCT01896089|"     This is a prospective, multi-center, observational study to determine if a combination of     desensitization and enrollment in a regional kidney paired donor (KPD) exchange program     improves the overall rate of kidney transplantation in sensitized patients.   "
106190|NCT01896076|"     Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in     low abdominal or urologic surgery.      An exact understanding of the anatomy of the sacral area including sacral hiatus and     surrounding structures is crucial to the success of caudal block.      The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by     ultrasound evaluation.   "
106191|NCT01896063|"     Insomnia is a common clinical disease.The serious patients could not sleep all night, often     accompanied by headache, dizziness, forgetfulness and so on. All of these increase the mental     burden of insomnia patients and seriously affected the normal work and quality of life of     patients. Modern medical treatment to treat insomnia is using sedative and hypnotic drugs,     mainly benzodiazepine, zopiclone. But long-term use of these drugs can induce the adverse     reactions, including resistance, dependence and addiction. Many articles indicate that     electroacupuncture can effectively improve insomnia, play the role of sedative and hypnotic     effect and avoid many adverse reactions and side effects. Then there are no more objective     indicators to affirm that which part of brain takes place the appropriate changes when     electroacupuncture induces the sedative effect. So we designed this experiment.   "
106232|NCT01895530|"     The investigators would study about impact of the administration of probiotics in the     intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by     quantitative real time PCR. The investigators believe that patients who use probiotic     preoperative would provide cytokine profile less inflammatory than those of the control     group.   "
106192|NCT01896050|"     Early stage hormone receptor positive breast cancer is typically treated with adjuvant     endocrine therapy in order to decrease risk of breast cancer recurrence and to improve     overall survival from the disease. Typical agents used for treatment include tamoxifen and     the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is     increasingly common because it is associated with fewer long-term serious toxicities compared     to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which     can influence adherence to therapy and can lead to treatment discontinuation in a minority of     cases. The mechanism underlying development of this toxicity remains unclear, and predictors     of who will develop these symptoms remain undefined. Initial reports suggest that grip     strength decreases during aromatase inhibitor therapy, and that body-mass index may influence     development of this symptom. Therefore, this longitudinal study has been developed to     determine change in grip strength over time in women treated with aromatase inhibitors and     tamoxifen, as well as to identify potential associations between change in grip strength and     BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early     stage breast cancer who are initiating therapy with either an aromatase inhibitor or     tamoxifen will be enrolled.   "
106193|NCT01896037|"     People with a spinal cord injury (SCI) characteristically have low levels of high-density     lipoprotein-cholesterol (HDL-c; good cholesterol) and high levels of low-density     lipoprotein-cholesterol (LDL-c; bad cholesterol), and are at a higher risk of developing     cardiovascular health problems, such as heart disease, heart attack and stroke, than the     able-bodied population. A common way for able-bodied people to improve their lipid profile is     through exercise; however, SCI people, especially tetraplegics, are often unable to achieve     and maintain a level of exercise needed to obtain these benefits. It is therefore clinically     important to find an effective, safe and inexpensive method of increasing HDL-c levels in     people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty     acid supplementation on the lipid profile of people with tetraplegia. The investigators     hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will     increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of     cardiovascular health issues.   "
106239|NCT01895439|"     1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical          scale according to Good Laboratory Practice using xenogenic free media instead of the          previously used FCS.        2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients          who fail to respond to conventional treatment.        3. Assessing the therapeutic benefits on the participants in the trial as per established          methods.   "
106194|NCT01896024|"     The present research aims at examining the effectiveness of a specific set of therapist     relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship     (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients     diagnosed with Borderline Personality Disorder.      The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality     Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers     Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of     Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne,     Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition     (General Psychiatric Management; Gunderson & Links, 2008) and 2) MOTR-condition. The     investigators hypothesize better results in the MOTR-condition, as compared to the control     condition in terms of symptom reduction pre-post.      The conduct of the study represents a significant contribution to the understanding and     enhancement of relationship aspects in the treatment of patients diagnosed with Borderline     Personality Disorder which may be of potential benefit for these patients.   "
106195|NCT01896011|"     Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often     occur without warning, are highly debilitating, and are slow to heal. As physicians learn     more about them, AFFs are increasingly being identified prior to a total break. However,     there's no evidence on the best way to treat these non-displaced AFFs. One option is     teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct     a double blind randomized placebo controlled trial to examine whether teriparatide use in AFF     patients with an incomplete break will help accelerate fracture healing and prevent surgical     intervention. Co-primary outcomes include change in WOMAC scores from baseline to 12 months     and number of participants requiring surgical intervention at 12 months. Investigators will     recruit 60 women and men over the age of 30 who have experienced an incomplete AFF.     Participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using     an identical injection pen) for up to 2 years. As AFFs are highly debilitating, a trial     examining the use of Teriparatide in this population is urgently needed.   "
106196|NCT01895998|"     The proposed research study is a cross-sectional study enrolling young children with sickle     cell disease between 5 and 12 years of age. They will be screened as outpatients for consent     to perform pulmonary function testing (PFT) and echocardiography. In addition, the degree of     bronchodilator response will be assessed at each session. To estimate presence of pulmonary     hypertension, echocardiography will be performed at the time of PFT measures.      Study Design:        1. Enroll children aged 5 to 12 years of age with sickle cell disease (HbSS, HbSC, HbS beta          plus thalassemia, HbS beta zero thalassemia, and HbS OArab) who are established patients          within the Duke Pediatric Sickle Cell Clinic.        2. Perform a chart review of all enrolled subjects to obtain specific details regarding          birth history, nutritional status (weight, height), family history, sickle cell          genotype, parental smoking history, recent laboratory parameters, parental smoking          history, any concurrent conditions (atopy, asthma, airway anomaly), history of sickle          cell complications and prescribed medications.        3. Perform spirometry and plethysmography with the administration of albuterol.        4. Before or after completion the PFT session, the patient will have echocardiography in          the PFT lab area        5. Using medical record information, determine number of hospitalizations for any pulmonary          symptoms indicative of acute chest syndrome (ACS) (dyspnea, fever, wheezing, hypoxia,          cough, chest pain). In addition, we will track any respiratory or cardiac symptoms or          therapies for each subject 6 years after enrollment up to age 18 years using the          registry.        6. As standard of care, refer any child identified as having lung disease or pulmonary          hypertension to a pediatric pulmonologist and/or cardiologist for monitoring, treatment          and ongoing care.   "
106197|NCT01895985|"     The objective of this study is to evaluate the effect of latanoprostene bunod dosed once     daily (QD) in reducing intraocular pressure (IOP) measured over a 24-hour period in healthy     subjects.   "
106198|NCT01895972|"     The objective of this study is to demonstrate the clinical safety of latanoprostene bunod     0.024% once daily (QD) over a 1-year treatment period.   "
106233|NCT01895517|"     The aim of this study is to assess efficacy of the screening with concurrent liquid-based     cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.   "
106199|NCT01895959|"     The purpose of this study is to identify novel imaging markers for characterizing the     biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after     intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.      We hypothesize that:        1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical          changes within knee synovial fluid after HA injection;        2. Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of          glutamate will predict patient response of pain relief after HA injection;        3. MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical          changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and          T2 will decrease in patients who respond to the treatment, indicating potential          beneficial effects of HA injection to cartilage preservation.   "
106200|NCT01895946|"     Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure,     Safety and Tolerability   "
106201|NCT01895933|"     This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan     formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after     endoscopic sinus surgery.   "
106202|NCT01895920|"     This project aims at characterizing HIV-1 viral biofilms structural and functional properties     and at deciphering its role as a new viral reservoir and as a new mode of viral spread. The     prospective national study will be conducted on cells isolated from blood samples from 20     patients infected with HIV.   "
106203|NCT01895907|"     The purpose of this study is to examine if Special Olympic athletes's life participation     improves through involvement with Special Olympics. This project will be undertaken in     coordination with Special Olympics entities from Texas and around the nation to determine how     involvement in Special Olympics improves the strengths and limitations of their athletes. The     Short Child Occupational Profile (SCOPE) will be used to gather this information from the     parents and coaches. The SCOPE measures the impact that personal and environmental factors     have on a child or youth's occupational participation.   "
106204|NCT01895894|"     Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients     need other immunosuppressants to reduce steroid dependency. The long-term use should be     restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.      Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have     similar efficacy and fewer undesirable effects to other drugs in mainly observational     studies. To determine the efficacy of mycophenolate mofetil in the management of     steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized     controlled study.   "
106205|NCT01895881|"     This study aims to determine if hormone replacement therapy, given during perimenopause may     prevent the progression of saccular cerebral aneurysms.   "
106206|NCT01895868|"     The clinical effects of simulation-based ultrasound training has not yet been explored. To     examine the long-term effects of training, we plan to conduct a trial, where half of all new     residents are randomized to simulation-based training and the other half to traditional     clinical training only. The effects are assessed after two months of practice by evaluating     two ultrasound scans performed by the residents. These scans are subsequently evaluated by a     blinded consultant gynecologist and rated using the Objective Structured Assessment of     Ultrasound Skills, which has been validated in previous studies.   "
106207|NCT01895855|"     the purpose of the study is to determine if PXVX0200 is safe and effective in preventing     cholera infection   "
106208|NCT01895842|"     The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib     that can be given to patients with low or intermediate-1 risk MDS. The safety of this drug     will also be studied, and whether it can help to control the disease.   "
106209|NCT01895829|"     The goal of this clinical research study is to learn if ferumoxytol, when given at the time     of a magnetic resonance imaging (MRI), can help researchers learn more about the spread of     certain kinds of cancers.      Ferumoxytol is designed to deliver iron to treat iron-deficiency anemia (low red blood cell     counts) in patients with chronic kidney disease. In this study, it will be used as an MRI     contrast. Contrasts are used by doctors in order to see MRI images more clearly.   "
106210|NCT01895816|"     The purpose of this study is to determine whether the effect of mixed herbals drug (citrus,     citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male     infertility: oligospermia   "
106211|NCT01895803|"     Discovery of factors affect the decision of the woman to perform or not to perform a Pap     test.Participate in the study 100 women who smoke. Age range 18-60   "
106212|NCT01895790|"     This research is being done to assess the effects of pancreatic duct stenting on relief of     obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by     pancreatic cancer.   "
106213|NCT01895777|"     This open-label, randomized, parallel-group, active-controlled, multi-centre non-inferiority     study of dabigatran etexilate versus standard of care in children from birth to less than 18     years of age will assess the efficacy and safety of dabigatran relative to low molecular     weight heparins or vitamin K antagonists for treatment of VTE. This study will also assess     the appropriateness of the proposed dabigatran doses for use in paediatric patients using     three different formulations of dabigatran (capsules, pellets and oral liquid formulation)   "
106214|NCT01895764|"     The purpose of this study is to determine if association of methotrexate with adalimumab     leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.   "
106219|NCT01895699|"     Contrast medium is essential for diagnosis of many diseases. However, recent studies showed     that contrast agents can induce renal injury and is associated with poor long-term clinical     outcome, especially in diabetes. To date, no data are available on the relationship between     contrast medium and endothelial function. Endothelial dysfunction is known to precede     atherosclerosis and is considered a risk marker for future development of cardiovascular     disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction     in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction     via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial     dysfunction induced by contrast agents.   "
115683|NCT01771653|"     The purpose of this observational study is to compare two approved treatment regimen(s)     containing boceprevir and telaprevir, as part of standard of care for the treatment of     hepatitis C.   "
106215|NCT01895751|"     Background: Most coronary artery bypass grafts (CABG) are diseased or blocked within 10 years     of surgery meaning CABG survivors have an ever increasing risk of recurrent angina, heart     attack and death. Given the large number of CABG survivors in the United Kingdom (UK), and     the complexities of their clinical management, their heart health problems and related     treatment are an increasing challenge in the UK National Health Service (NHS) and worldwide.      There is considerable controversy in the NHS and internationally about how to best manage     patients with prior CABG and unstable angina / non-ST elevation acute coronary syndromes     (NSTE-ACS). This is because there is no robust evidence to inform treatment practices or     clinical guidelines since, historically, these patients have been excluded from randomised     trials. This is the rationale for our study.      Aims: Our overall aim is to undertake a clinical trial of conservative non-invasive     management with optimal drug therapy versus routine invasive management in NSTE-ACS patients     with prior CABG during routine clinical care in NHS hospitals across the UK. Our trial is a     proof-of-concept study of feasibility, safety, potential efficacy and health economics.      Hypothesis: A routine invasive approach in NSTE-ACS patients with prior CABG will not be     superior to a conservative non-invasive approach with optimal medical therapy.      Design: The pilot study will involve 60 patients recruited in large urban hospitals (Western     Infirmary, Glasgow Royal Infirmary) and district general hospitals (Royal Alexandra Hospital,     Royal Blackburn Hospital (RBH)) to reflect usual practice in the UK. One of these hospitals     (RBH) has an on-site cardiac catheterization laboratory, whereas the other hospitals refer     patients who have been triaged for invasive management to the regional cardiothoracic centre     (the Golden Jubilee National Hospital). In this proof of concept study, the investigators aim     to gather information about screening, recruitment, randomisation, patient characteristics     (including comorbidity and quality of life) and initial clinical outcomes to inform the     design of the definitive trial. The follow-up will be in line with standard clinical care     i.e. 30-42 days and 1 year. The investigators will hold data in the longer term to enable     long-term follow-up analyses. The investigators will record information on NSTE-ACS patients     with prior CABG who are ineligible to take part or who do not wish to be randomised as part     of all follow-up registry of 'all-comers'.   "
106216|NCT01895738|"     Youth injured by violence is a major public health concern in Canada. It is the fourth cause     of death and the leading reason for a youth to visit an emergency department (ED). In     Winnipeg, 20% of youth who visit an emergency department with an injury due to violence have     a second visit for a subsequent violent injury within the following year. This is consistent     with studies in other jurisdictions that demonstrate that violent injury is a chronic     condition. Youth injured by violence are in a reflective and receptive state of mind,     rendering the emergency department setting appropriate for intervention. The investigators     propose a WrapAround Care model delivered by a support worker with lived experience with     violence, supported by a social worker, an addictions and mental health counsellor, a family     counsellor and links to multiple community partners. Support workers will be on call 24 hours     a day, 7 days a week in order to start the intervention in the ED and take advantage of the     teachable moment. The proposed study is a pilot randomized control trial to assess the     feasibility of a randomized control trial designed to assess efficacy. For the pilot trial     the investigators will assess recruitment, treatment fidelity, participant adherence and     safety. The intervention arm will receive wraparound care initiated at the time of their     visit for injury due to violence. The control arm will receive standard of care (usually a     list of community contacts). The investigators will use an adapted pre-consent randomization     methodology. This intervention has been developed using a community based participatory     research approach. Our team includes clinicians, nurses, social workers, community youth     workers, ex-gang members, elders and researchers.   "
106240|NCT01895426|"     The purpose of this study is to collect clinical and radiological mid-term (2 years) data on     the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF)     limited to 32 patients.   "
106241|NCT01895413|"     This is a non-randomized study aimed to determine the safety and efficacy of intra-articular     injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee     articular cartilage defects.   "
106242|NCT01895400|"     The purpose of this study is to determine whether Renexin is effective in the treatment of     vestibular symptoms in patients with recurrent vestibulopathy.   "
106217|NCT01895725|"     The proposed project is a prospective observational, single-center cohort study aimed to     examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque     volume) during a follow-up of up to four years and to correlate the observed changes with     traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with     or established cardiovascular disease or at least one cardiovascular risk will be tested with     a high-frequency ultrasound probe equipped with automated IMT measurements and 3D     quantitative plaque volumetry. Plasma samples will be collected and tested for traditional     and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will     be repeated once per year to assess changes in these parameters over time depending on     treatment modalities, which are left to the discretion of the treating physicians. The     primary endpoint of the planned study will be the correlation between P-selectin and the     progression of atherosclerosis as measured by plaque volume and IMT in the carotid and     femoral arteries, respectively. Secondary endpoints will include the correlation of     established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP,     P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1     (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation     of cardiovascular events with the progression of atherosclerosis and the additional     predictive value of plaque volume and IMT compared to an established risk score (SCORE card).   "
106218|NCT01895712|"     For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to     long-term complications range from rather immediate elastic recoil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from     30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents     (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical     restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still     occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug     Eluting Stents (DES) significantly improved on the principle of BMS by adding an     antiproliferative drug (directly immobilized on the stent surface or released from a polymer     matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the     incidence of restenosis and resulted in a better safety profile as compared to BMS with     systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease.      An interesting group of analysis resulted to be diabetic patients. It has been concluded that     the incidence of both nonocclusive and occlusive restenosis is higher in diabetic subjects     after stenting as judged from comparison with historical control subjects. Results implicate     accelerated restenosis as both a consequence of diabetes and a cause for increased mortality     after PCI in diabetic patient.      Therefore this observational registry has been designed for the clinical evaluation of the     Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary     revascularization with Drug Eluting Stents (DES). Results will contribute to the collection     of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent     System in daily clinical practice.   "
106221|NCT01895673|"     The primary objective of this study is to evaluate the ability of PET-MRI and to detect a     local site recurrence during the first year of follow-up after RFA or MWA of colorectal liver     metastases (CRLM) as compared with contrast enhanced (ce) CT and PET-CT. Standard reference     will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with     histology (when available) or clinical follow-up.      Secondary outcomes are the inter-observer variability, the ability to diagnose new     intrahepatic lesions and in what way PET-MRI is able to influence future treatment compared     to PET-CT and ceCT. The patients satisfaction concerning the PET-MRI will be examined with a     questionnaire.   "
106222|NCT01895660|"     What is the CHAMP Study?      The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health     that is comparing the efficacy of alternative therapies for young children with unilateral     spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility     criteria at one of the three clinical sites (Roanoke, VA; Charlottesville, VA, and Columbus,     OH) will be invited to enroll, and their parents will be provided all necessary paperwork     along with informed consent documentation. Assignment to one of the alternative therapy     conditions will be random. Participation in the study includes assessment of each child prior     to treatment, close monitoring of the child's progress during treatment, and post-treatment     evaluation at the end of therapy, as well as, 6 and 12 months later. Parents will have an     active role in the project, both observing their child during therapy sessions and then     engaging in home-based activities that allow the child to practice and extend new motor     skills. There will be no charge for the therapy provided.      What are the therapies being tested? In the past decade or so, a new form of therapy for     children with hemiparetic cerebral palsy was developed and has shown to produce positive     changes in individual children and in small clinical trials (e.g., DeLuca, Echols, Ramey, &     Taub, 2003; DeLuca, Echols, Law, & Ramey, 2006; Case-Smith, DeLuca, Stevenson, & Ramey,     2012). The therapy is named Constraint-Induced Movement Therapy (CIMT) and refers to a     multi-component form of therapy in which the child has the unimpaired or less impaired upper     extremity constrained (by a cast or a splint) while also receiving active therapy from a     specially trained therapist who shapes new skills and functional activities with the child's     more impaired upper extremity. Traditionally, CIMT therapy dosages have been high - often     lasting many hours per day, 5 days a week, for 4 consecutive weeks. There are important     clinical and scientific questions that need to be answered about the effects of different     dosage levels and about different types of constraint on the child's more functional (less     impaired) arm and hand. This study will be the first that will directly compare different     amounts of therapy and different types of constraint to evaluate what works best for young     children. The therapy is very play-like and engaging for children, and no negative effects of     casting or the high dosages have been detected in previous clinical trials.      Who is eligible: Children between 2 and 8 years of age with a diagnosis of unilateral spastic     cerebral palsy or hemiparetic cerebral palsy. Children must be relatively healthy, not     currently receiving Botox (or other similar medications), and able to understand simple     communication and instructions. In advance, the treatment will be explained in detail to     parents and a written protocol available to share with the child's physician and other     current therapist for review. During the one month of treatment, children will not receive     other forms of physical or occupational therapy.   "
106223|NCT01895647|"     Rationale : Electric muscle stimulation reduced critical-illness related weakness in patients     with severe sepsis and septic shock. But optimal protocol of the stimulation in unknown.      Hypothesis: Focal muscle contraction may improved the muscle power and have systemic     anti-inflammatory via cytokine secretion . The difference of electricity used in upper limb     or lower limb stimulation may lead to different effect.      Study design: Stratified randomized parallel control study, comparing Biceps, Quadriceps     electric muscle stimulation vs. non-stimulation group.      Participant: adult patients with severe sepsis and acute respiratory failure requiring     mechanical ventilation.      Intervention: daily stimulation of bilateral Biceps or Quadriceps by programmed electric     devices 32 minutes, 5 days/week      Outcome:        1. Primary outcome: Ventilator-dependent days        2. Secondary outcome: change of hand drip muscle          power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha   "
106224|NCT01895634|"     The main objective of this study is to document that the thrombectomy catheter (Rev-01) is     effective and safe when used for revascularization in subjects with acute ischemic stroke     within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom     treatment with IV t-PA has been ineffective.   "
106243|NCT01895387|"     We determined the effects of dietary intervention (replacement of refined rice with whole     grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and     enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired     fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.   "
106244|NCT01895374|"     Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.   "
106772|NCT01888484|"     This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a     12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm     in preventing serious bacterial infections (SBI) compared with historical control data and to     evaluate the pharmacokinetic (PK) characteristics of octanorm.   "
106225|NCT01895621|"     The postoperative course of the decompression of the median nerve in the carpal tunnel     syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or     may be characterized by a slow recovery of nerve function. Lipoic acid is considered to be a     powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary     supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action     as a dietary supplement may positively modulate and accelerate healing after decompression of     the median nerve.      The aim of the study is to explore any possible effects of this molecule in the postoperative     period after decompression of the median nerve at the wrist.      Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization,     patients will be placed into one of two groups:      Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg     daily for 40 days.      Group B: surgical decompression of the median nerve followed by treatment with placebo      The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery     after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.   "
106226|NCT01895608|"     The first goal of this study is to examine the extent to which the inclusion of dual-task     practice to standard balance rehabilitation results in greater benefits to dual-task ability.     The second goal of this study is to examine the extent to which the addition of cognitive     training following balance rehabilitation results in greater benefits to dual-task ability.   "
106227|NCT01895595|"     Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to     reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease risk     in obese Latino adolescents. The overall purpose of this study was to determine whether     guided imagery, could reduce diabetes risk in obese Latino adolescents undergoing a lifestyle     intervention. The specific objectives were: 1) To pilot test a new 12-week lifestyle     intervention in obese Latino adolescents, in order to determine the effects of the mind-body     technique of Interactive Guided ImagerySM, over and above those of healthy lifestyle     education, on eating and physical activity behaviors, stress and stress biomarkers, and     hormonal markers of diabetes risk; and 2) To explore the way that changes in stress produced     by the intervention were associated with changes in hormonal markers of diabetes risk,     particularly insulin resistance. The investigators hypothesized that participants who     received guided imagery program in addition to the healthy lifestyle education would show     greater improvements in insulin resistance, physical activity, dietary intake, and stress,     than those receiving the healthy lifestyle education without the guided imagery. The     investigators further hypothesized that reductions in stress due to the intervention would be     associated with improvements in insulin resistance, a major hormonal marker of diabetes risk.     For this study, obese, Latino adolescents (age 14-17) were randomized to receive either 12     weekly sessions of the lifestyle education plus guided imagery program, or lifestyle     education plus a digital storytelling computer program (as a control). Outcome measures were     assessed before and after the 12-week intervention, comparing the differences between the     intervention groups behavioral (eating and physical activity behaviors), biological (insulin     resistance and stress hormones), and psychological (stress) outcomes.   "
106228|NCT01895582|"     Background: Diagnosis and screening for latent tuberculosis in old patients is of special     interest in regards of the morbidity-mortality of this disease in that context.      TB-infection diagnosis based on immunological memory detection can be impaired with age. New     blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in     those old patients.The primary endpoint of this study is the evaluation of the IGRAS for     active TB diagnosis in patients above 75 years old.   "
106229|NCT01895569|"     The treatment of type 2 diabetes mellitus often requires the use of one or more hypoglycemic     agents to reach the adequate glycemic control. The aim of the study is to evaluate the     effects of a triple therapy with metformin, pioglitazone and sitagliptin on glycemic     variability compared to metformin monotherapy, and compared to a combination of metformin and     pioglitazone. To assess glycemic variability a continuous glucose monitoring system will be     used.   "
106230|NCT01895556|"     The purpose of this study is to measure the behavioral effects of learning information about     male circumcision and HIV risk on sexual behavior and the demand for male circumcision.   "
106231|NCT01895543|"     Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation     (CIC)   "
106234|NCT01895504|"     Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the     rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for     different reasons, and features of the colonoscope and the use of imaging devices may     influence the success rate. We want to compare the performance of a new colonoscope with     novel features including gradual stiffness with that of a colonoscope supplied with a     magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new     instrument is non-inferior to the MEI system.   "
106235|NCT01895491|"     The main objective of this study is to evaluate the safety of VM206RY in subjects with     expression of HER2 in breast cancer.   "
106236|NCT01895478|"     This study examined whether the Pediatric Asthma Control and Communication Instrument for the     Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency     department accurately assess a child's asthma control.      This study involved an intervention with the doctors in the emergency department of an urban     pediatric hospital. The intervention was done when one of the doctors involved in the study     treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the     PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED     results and half were not. The two groups of doctors were compared on their ability to     correctly identify asthma control categories, whether a child's asthma was worsening or     improving, whether the family was administering controller medications as often as they     should, and how much burden the child's asthma was for the family.   "
106237|NCT01895465|"     The population of children presenting to the Emergency Department (ED) for treatment     increases day by day, creating a further burden on the limited nursing staff and where many     children and their parents are forced to wait many hours until their medical investigation     ends. Part of the many hours waited are for various tests the patient has to undergo, where     the urine test is one of the main ones.      Urinary tract infections in children are a common cause of death due to acute and chronic     complications alike. Our study aims to test a urine collection method to see whether it     reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's     percentage of contamination.   "
106245|NCT01895361|"     The purpose of this study is to determine whether the investigational drug SelG1 when given     to sickle cell disease patients either taking or not taking hydroxyurea is effective in     preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the     bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may     prevent small blood vessels from becoming blocked and therefore reduce the occurrence and     severity of pain crises. Other effects of SelG1 will also be evaluated, as well as the safety     of the drug and how long it stays in the blood stream.      Funding Source - FDA Office of Orphan Products Development (OOPD)   "
106246|NCT01895348|"     Obstructive sleep apnea is a common disease, associated with cardiovascular disease,     cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis     and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional     evaluation of upper airway and airway obstruction could be possible. The problem of the DISE     is that there is the difference between a sedative-induced sleep and normal sleep. Moreover     there were no standard sedation protocol of DISE. Propofol has short half-life, about 3     minutes, so the patients could recover quickly from it. In recent years, using target     controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could     be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot     study, the endoscopy for the diagnosis of sleep apnea could be done successfully with     propofol TCI. However there were some desaturation events, although the EEG showed that the     patient was not in deep sleep enough. Therefore we thought that not only further study of     propofol for DISE but also the study of other drugs for DISE will be needed to overcome this     limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect     and almost no respiratory depression, therefore it could be a good alternative drug for DISE.     The purpose of this study is designing the appropriate sedation protocol for DISE using     propofol or dexmedetomidine, and enabling the safer and more accurate DISE.   "
106247|NCT01895335|"     Primary Objective:      To describe efficacy, tolerability and convenience of teriflunomide treatment through the     evaluation of Participant Reported Outcomes (PROs).      Secondary Objectives:      To describe disease progression using PROs. To describe clinical outcomes (ie, treated     relapses) in teriflunomide treated participant.      To describe the change in cognition in teriflunomide treated participants. To describe safety     of teriflunomide in participant treated (based on adverse events reporting).      To describe adherence and persistence to teriflunomide treatment. To describe quality of     life, activity and leisure over the period of teriflunomide treatment.      To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale     (EDSS) in assessing Multiple Sclerosis (MS) disease progression.   "
106248|NCT01895322|"     To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in     patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine     volume, body weight, and edematous conditions as parameters and conducting dose escalation     every 2 days until reaching the dose that achieves urine volume increase and then performing     5-day repeated administration at the fixed dose, the final dose used in the dose escalation     period.   "
106249|NCT01895309|"     This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate     the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in     subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)     therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects     will be enrolled into an open label extension period. Subjects will receive SB4 for an     additional 48 weeks.   "
106259|NCT01895179|"     The purpose of this pilot study is to find out what eating meals in a short time period early     in the day (time-restricted feeding) versus eating meals spread out during the day (grazing)     does to the body's ability to control blood sugar and to the health of its blood vessels.      The investigators hypothesize that time-restricted feeding will be more effective at     improving glucose tolerance and vascular condition (inflammation and micro- and     macro-vascular function) than grazing.   "
106260|NCT01895166|"     The purpose of this study is to evaluate the efficacy and safety of endobronchial     ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs)     without radiographic fluoroscopy.   "
106250|NCT01895296|"     Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release     of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an     hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known     which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this     trial is to evaluate :        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during          OGTT).        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during          OGTT).        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters          of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after          an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as          measured by the combined Dumping Syndrome score        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured          by (a) early and (b) late phase dumping symptom score separately        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL          SF-36)   "
106251|NCT01895283|"     Muscular dystrophy is a group of disorders that are characterized by progressive muscle     weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy     is almost always inherited disorders, and so far, no curative treatments exist.      Previous studies have shown that endurance training significantly improves fitness and     self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to     investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy)     also benefit from endurance training.      The study consists of two test days, a 10-week training period and five blood tests.      Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer     with a specific training intensity, under pulse rate monitoring.      The training period will be flanked by two test days, where we will determine, and compare     the patients' muscle strength and fitness level, from before to after the training program.     The patients conditioning level will be determined from a 15 minute cycle ergometer test and     patients will undergo three functional tests to determine their functional muscle strength.      We will as a safety measure analyze blood tests before, during and after the training program     for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse     effects as reported by patients during weekly telephone-consultations with the Principal     investigator.      We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and     functional muscle strength, as that seen in patients with other forms of muscular dystrophy,     who undertake a similar training program.   "
106276|NCT01894958|"     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the     treatment of Fragile X Syndrome in adolescent and adult males.   "
106252|NCT01895270|"     This application seeks to address the problem of opioid withdrawal by examining the utility     of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification.     This project will address the need for improved detoxification strategies by assessing the     tolerability and preliminary efficacy of adjunct isradipine during a BUP detoxification in     opioid-dependent participants. This pilot clinical trial will determine the potential utility     of the L-type CCB isradipine to improve treatment outcomes in up to 60 opioid-dependent     individuals undergoing a BUP detoxification procedure. Specifically, this study will     determine the efficacy of isradipine to reduce withdrawal symptoms, craving, and illicit use     of opioids in opioid-dependent individuals undergoing BUP detoxification and determine the     tolerability and safety of controlled-release isradipine (10 mg/day) in opioid-dependent     individuals undergoing BUP detoxification. Currently, the only FDA-approved medications for     opioid withdrawal are the opioid agonists methadone and BUP, both of which have abuse     liability. Our findings, if positive, will support a larger phase II clinical trial.   "
106253|NCT01895257|"     The investigators propose to conduct a randomised phase III trial evaluating a maintenance     strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus     continuing simplified chemotherapy with/without targeted therapy versus continuing simplified     chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and     unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.   "
106254|NCT01895244|"     Autologous stem cell therapy has been shown to be effective in patients with systemic     sclerosis. Nevertheless treatment is associated with treatment related mortality and patients     die during follow up despite successful transplantation.      Intention of this trial is to improve overall survival by modifying the existing protocol     used for the ASTIS trial.      To reduce treatment toxicity we reduce the dose of Cyclophosphamide (CYC) for mobilisation to     2x1g.      Especially in patients with cardiac manifestations we also modify the conditioning regimen by     adding thiotepa and reducing CYC; as CYC has known cardiotoxic side effects.   "
106255|NCT01895231|"     The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000     compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L   "
106256|NCT01895218|"     The primary purpose of this study is to compare the efficacy of IV high single dose infusion     of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical     fatigue.   "
106257|NCT01895205|"     The primary purpose of this study is to get explorative information about IV high single dose     infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe     PP-IDA evaluated as physical fatigue   "
106258|NCT01895192|"     A new concept for observing the fine morphology of spermatozoa at high magnification (x6000)     with an inverted microscope, a numeric camera using differential interference contrast has     been developed (1). This technique called Motile Sperm Organellar Morphology Examination     allows to see some abnormalities, mainly vacuoles on the head of spermatozoa. These vacuoles     appear to be related to sperm DNA damage and to affect embryo developmental potential (2, 3,     4). The application of Motile Sperm Organellar Morphology Examination may represent an     improvement in the evaluation of semen quality, with some potential clinical repercussions at     the diagnostic/prognostic level. First of all, the investigators need data on fertile men in     order to define  normality  of sperm morphology at high magnification. The aim of this     study is therefore to better characterize these vacuoles (number, surface, position) in a     population of men fertile in order to establish normality criteria.   "
106265|NCT01895101|"     It remains still unclear whether topical tranexamic acid has an added value besides the     administration of intravenously tranexamic acid. We hypothesize that the addition of topical     tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25%     reduction of post-operative blood loss after cardiac surgery.      The aim of this study is to determine whether the application of topical tranexamic acid     reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery     on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.      Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic     acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial     lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group)     receives no pericardial lavage. The main study parameter is 12 hours post-operative blood     loss and is assessed by 12 hours post-operative chest tube production.   "
106266|NCT01895088|"     This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in     subjects who are still implanted with the ACI and have successfully completed the     ACU-P08-020/020A studies.   "
106286|NCT01894828|"     The aim of the study was to assess the effect of nutritional supplementation on nutritional     status and postoperational complications in cancer patients with no clinical signs of     malnutrition   "
106267|NCT01895075|"     Bronchopulmonary dysplasia (BPD) is one of the most important morbidities of preterm infants     with a high incidence and significant impact on resource utilization and long-term outcome.     Systemic corticosteroids have been shown to be effective in the prevention of BPD through     their potent anti-inflammatory effects but there are serious concerns on their potential     detrimental effects on neurodevelopment of infants. In contrast, inhaled corticosteroids     administered to ventilated infants are thought to be safer due to their topical effect but     have not been shown to improve outcomes including BPD. To date, there have been few studies     evaluating the effect of inhaled corticosteroids administered to non-ventilated infants for     the prevention of BPD. Hence, we are conducting a double-blind randomized controlled pilot     trial to examine the impact of inhaled budesonide on non-ventilated infants.      The study objectives, in a cohort of very preterm infants with signs of early BPD are: 1) to     evaluate the effect of aerosolized budesonide on 'days on supplemental oxygen', and 2) to     gain an estimate of the impact on BPD and 3) to assess the safety of the intervention in a     small cohort of preterm infants.      This will be a single-center randomized double-blind controlled pilot trial. We will recruit     a total of 50 infants born at less than 30 weeks gestation who are on continuous positive     airway pressure (CPAP) with fraction of inspired oxygen ≥25% on day 14 of life or later.     Inhaled budesonide 1mg (intervention group) or normal saline (placebo) will be administered     three times a day until the infants do not need CPAP or supplemental oxygen or reach 36+0/7     weeks corrected gestational age. We will evaluate 'days on supplemental oxygen', BPD,     re-intubation rates, days on mechanical ventilation and days on CPAP as well as adverse     outcomes.      The prevention of BPD would have a significant positive impact on patient quality of life and     medical resource utilization and costs. The study hypothesis is that inhaled budesonide on     non-ventilated infants with early signs of BPD will reduce the 'days on supplemental oxygen'     indicating a positive effect for the prevention of BPD. The result of this pilot study might     also justify and support to proceed to a large confirmatory study to evaluate an effect of     the intervention on BPD, in which the estimate of the impact on BPD gained in this pilot     trial may be used to calculate a sample size.   "
106268|NCT01895062|"     The primary goal of this study is to determine the effectiveness and safety of delivering     continuous negative external pressure (cNEP) to the upper airway as a means of preventing     episodes of respiratory impairment (RI) such as hypoxemia, apnea and hypoventilation     associated with the use of intravenous sedation in elective colonoscopy in adult patients.   "
106269|NCT01895049|"     The disparity between supply and demand for organs has stimulated the development of     strategies to increase the availability of kidney grafts. Such strategy involves the use of     kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator,     open, prospective, randomized, single center designed to compare the safety and efficacy of     two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus     thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor     criteria expanded.   "
106270|NCT01895036|"     The efficacy of buprenorphine as a long-term agonist treatment has been offset by the     emergence of intolerable withdrawal phenomena in a subset of individuals on chronic     maintenance who attempt to discontinue the medication. Efforts are needed to better     understand these challenges encountered with buprenorphine, as well as to develop     interventions to facilitate medication discontinuation.      Emerging evidence suggests that these difficulties may be related to the unique effects of     buprenorphine on sites other than mu-opioid receptors, such as kappa-opioid receptors.     Kappa-opioid agonism produces aversive, dysphoric-like effects, and can also increase the     likelihood of reinstatement to drug use through stress-mediated mechanisms. Some of the     discomfort observed during drug taper may therefore be due to the attenuation or loss of     kappa-opioid antagonism afforded by buprenorphine, as well as to rebound kappa-opioid     activation. Naltrexone represents a promising candidate for extending kappa blockade and     therefore for facilitating discontinuation attempts. Naltrexone and its active metabolite     6-Beta-naltrexol are competitive antagonists at the mu and kappa receptors, and to a lesser     extent at the delta receptor. Naltrexone and buprenorphine have comparable affinity for the     mu-opioid receptor and thus buprenorphine is displaced by naltrexone more gradually than are     other opioids with less affinity; a careful titration of naltrexone is less likely,     therefore, to precipitate severe withdrawal states in individuals coming off buprenorphine,     and the two have been combined to good effect in other settings.      The purpose of this study is therefore to investigate the feasibility of naltrexone     augmentation on discontinuing buprenorphine in eligible patients on long-term maintenance.   "
106271|NCT01895023|"     Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid     onset and offset of action.The reported incidence of emergence agitation (EA) following     sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still     considered as a potentially serious complication because of the risks of self-injury, and     because of the stress caused to both caregivers and families.      Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic     actions, has been used in pediatric populations.Several prospective clinical trials in     children have shown that dexmedetomidine significantly reduces the incidence of EA prior to     recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on     emergence agitation has not been fully evaluated. The purpose of the present study was to     verify the hypothesis that intranasal premedication with dexmedetomidine is effective in     reducing emergence agitation after sevoflurane anaesthesia.   "
106272|NCT01895010|"     Observation on acupoint electric stimulation combined with tropisetron in preventing and     treating nausea and vomiting and improving the patient's appetite after TACE for primary or     metastatic liver cancer patients.   "
106394|NCT01893411|"     The purpose of this study is to determine whether injections of Botulinum toxin type A into     muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with     increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.   "
106273|NCT01894997|"     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among     hospitalized patients, with death occurring in approximately 6% of cases. It involves the     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to     blood vessel wall), collectively known as Virchow's triad.      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have     been shown to improve lower limb blood flow. However, few studies have directly compared the     two methods and those that have, have used dated NMES techniques.      The objective of this study is to compare the two methods in terms of blood flow, in both a     young and an older population.   "
106274|NCT01894984|"     The purpose of this study is to evaluate the long-term treatment efficacy, and safety of     risperidone long-acting injection in participants with schizophrenia (psychiatric disorder     with symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self).   "
106275|NCT01894971|"     Single-center prospective randomized trial to evaluate the effect of thermal damage of     Ligasure® to destroy cornual portion of fallopian tube tisse.      Right of Left side of fallpian tube is randomized and coagulated one more time than other     side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at     both cornual portion of cut off specimen.   "
106277|NCT01894945|"     This study aims to investigate the value of dual time point PET/CT in lymphoma. Since FDG     uptake is linked to glucose metabolism, PET imaging is also used to detect suspected sites     for infectious and inflammatory disorders. In a clinical setting, it is a challenge to     distinguish between FDG uptake in benign and malignant lesions and this gives rise to a     considerable quantity of false positive results and decreased positive predictive values.     Performing FDG-PET imaging sixty minutes after injection is common practice in the staging     and surveillance of lymphoma but this procedure may not be optimal, especially not in     settings where benign inflammatory lesions are of clinical concern.      In an attempt to find an alternative method for this discrimination, dual time point FDG-PET     was introduced. This technique has shown itself to be a potentially promising method in     FDG-PET imaging for distinguishing between malignant and benign lesions using SUV values. The     reason for the different FDG uptake patterns between inflammatory and malignant lesions is     unclear. Several factors may contribute to this phenomenon on a cellular basis. It has been     shown that cancer cells exhibit increased numbers of glucose transporter and low level of     glucose-6-phosphatase. Varying levels between different cancer cell types may explain the     different FDG uptake curves. Because various cell types exhibit varying rates of FDG uptake     we believe that kinetic investigation may prove to be of value in understanding different     types of lymphoma and identifying how to perform precise imaging for staging and     surveillance.   "
106278|NCT01894932|"     Cases of physical and psychological stress problems is the need to prevent the risk of     depression, primary care model will help to prevent depression. Many scholars have advocated     for depression treatment not only concern symptom control and relief, prevention of     recurrence should also be aware. The literature found cases had depression, with cognitive     strategy bias , may cause recurrence of depression, under the influence of stress. The study     was to assist the physical and mental disorder patient caused by stress and depression     patient having cognitive and emotional regulation, and increased adapting Ability by ongoing     two separate treatment groups ,Mindfulness-based Cognitive Group Therapy and     psycho-physiological stress regulation Group Therapy. In addition, psychological groups can     also help regulation daily Trivia stress, study will try to know about how group therapy's     effects on patient's immune system.Research has three purposes,to validation 2 group model's     results in assisting psycho-physiological stressed and depression patient, to establish group     leader training center and prepare groups' standard procedure manuals,and to understand the     patient's psycho-physical stress reaction on the immune system and fat cell hormone.   "
106279|NCT01894919|"     The aim of this extension study is to explore the antibody persistence 24 to 36 months after     the last dose of vaccine, in infants that received a two or three dose primary series plus a     booster dose at 11 months of age, of the Novartis meningococcal B vaccine (rMenB + OMV NZ) in     groups I to III of the parent V72_28 study.      This study will also explore the antibody persistence 24 to 36 months after two catch-up     doses of the Novartis meningococcal B vaccine (rMenB + OMV NZ) administered in children (2 to     10 years old) in group IV of the parent V72_28 study.   "
106280|NCT01894906|"     The purpose of this study is to determine the quantity of iron derived from SFP that is     transferred from the dialysate to patients during a single dialysis session. The effects of     various conditions which may affect the transfer of iron such as blood and dialysate flow     rate, changes in bicarbonate delivery, dialyzer membrane type and the effect of reuse will     also be investigated. The absorption and removal of iron from the blood will also be     investigated.   "
106281|NCT01894893|"     The main objective of this clinical trial is to collect human milk samples from 0 to 4 months     after delivery in order to characterize human milk components. The secondary objectives of     this study are:        1. To assess whether there is a correlation between human milk composition and mothers'          diet        2. To assess whether there is a correlation between human milk composition and maternal          clinical parameters        3. To assess whether there is a correlation between human milk composition and mother and          infant clinical parameters   "
106282|NCT01894880|"     In the past decades frequency of cesarean section was increasing. Bonding or early     skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery     bonding/early SSC is already well-established. After cesarean section this important process     starts after termination of operation. A Cochran review analyzed randomized studies and shows     positive effects of early SSC. Possible concerns to adopt bonding in the operating room are     beside organizational ones (change of established processes) also a different ambiance in the     operating room (temperature, light, noise). In a prospective randomized trial, early SSC     after cesarean section should be analyzed.      Hypothesis      Mothers, who have the chance to bond immediately after birth in the operating room, have     lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels.     Adaptation of the newborn is within the normal range. Early bonding has a further positive     effect on breast feeding, maternal pain processing and mental health.   "
106283|NCT01894867|"     Several studies have shown in patients magnesium deficiency with liver cirrhosis.      Patients with liver cirrhosis showed considerably reduced muscle strength and muscle     magnesium.      We suggest addition of magnesium to patients with established cirrhosis in order to reduce     the neuromuscular and neuropsychiatric manifestations of chronic liver disease.   "
106284|NCT01894854|"     The aim of this study is to further investigate the clinical and radiological importance of     design changes in cementless hip prosthesis. The investigators have earlier evaluated the     classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a     further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore,     comes with and without a collar, and the investigators are going to randomize between the     two. The investigators hypothesize that the new design will be easier to implant and will     present equal or less migration than the older designs which would imply a favourable outcome     in the long term. The investigators further hypothesize that the collar play no major part     for the long term migration and bone remodelling.   "
106285|NCT01894841|"     The proposed study seeks to test the efficacy of an intervention to reduce suicide behaviors     in Veterans. The Veterans Coping Long Term with Active Suicide Program (CLASP-VA) is an     innovative, telephone-based intervention that combines elements of individual therapy, case     management, and significant other/family therapy and is designed to be integrated into a VA     system.   "
106287|NCT01894815|"     Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with     antidepressant drugs, which are limited for issues such as refractoriness and adverse     effects. In this context, the investigators investigate a non-pharmacological treatment known     as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective     than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is     virtually absent of adverse effects. Its ease of use, portability and low price are also     interesting characteristics for using in primary and secondary health care. Thus, our aim is     to compare tDCS against a fully dosed, effective antidepressant. The study will be a     non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing     active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our     primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a     noninferiority margin of at least 50% of the escitalopram-placebo effect.   "
106288|NCT01894802|"     The purpose of this research study is to demonstrate the safety and efficacy of using two CRS     Arrays (microelectrodes) for long-term recording of brain motor cortex activity and     microstimulation of brain sensory cortex.   "
106289|NCT01894789|"     Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary     syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial     tissue. Overall benefits of one drug over the other is neutral in this generally unstable     population. In pre-clinical trials, ticagrelor showed secondary effects, involving the     release of adenosine to heart muscle where the demand for blood was increased due to a stress     condition. Blood flow was increased, potentially preventing potential damage.      This study will compare ticagrelor, currently only approved for use in ACS patients, against     clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this     phenomenon. The effect on blood flow will be measurable by using two specific doses of     adenosine as the pharmacologic stress and correlating with measurements of blood flow using     positron emission tomography (PET) nuclear imaging.      This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion     will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects   "
106290|NCT01894776|"     Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to     characterize the pharmacokinetic properties of maraviroc alone and when administered with     rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to     the literature.   "
106291|NCT01894763|"     Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by     placement of a stent (a flexible, expandable tube that props open the blockage caused by the     cancer). Stents are effective but can cause complications. Stents come in different     diameters. The purpose of this study is to learn if stents of different diameters are more or     less effective for treatment of dysphagia caused by esophageal cancer.   "
106292|NCT01894750|"     The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral     intervention to improve heart failure self-care among community dwelling older adults.The     primary aim of this study is to test the effect of the intervention on improving heart     failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We     will test three hypotheses comparing 60 older adults with heart failure randomly assigned to     either the intervention or a control group:      Hypothesis 1. Participants in the intervention group will have significantly improved heart     failure self-care than control participants.      Hypothesis 2. Participants in the intervention group will have significantly improved     knowledge about heart failure and heart failure self-care than control participants.      Hypothesis 3. Participants in the intervention group will have significantly better Health     Related Quality of Life than control participants.      A secondary exploratory aim is to assess and describe implementation feasibility of providing     a heart failure self-care intervention in a community group setting.   "
106293|NCT01894737|"     The primary aim of this study is to determine the effect of creatine supplementation on     muscle mass loss during short-term immobilisation in healthy, young people.   "
106294|NCT01894724|"     This study designed to evaluate the safety and feasibility of the NeuroSave device to rapidly     reduce brain temperature while maintaining the brain at a lower temperature than the body     core during cardiac surgery.   "
106327|NCT01894282|"     This pilot study will evaluate the feasibility of having a non-behavioral health provider     deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain     (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the     combined intervention of CBT-p and MT and those undergoing MT alone.   "
106372|NCT01893697|"     FRI could give the opportunity to investigate the possible effect of a lateral posture on     airway diameter and airflow distributions. This physiological study in healthy subjects may     help to identify the role of positioning as an aid in airway clearance techniques for     patients with respiratory diseases.   "
106295|NCT01894711|"     AIM To determine the value of trastuzumab in the early breast cancer setting in the     Netherlands.      RESEARCH QUESTIONS / OBJECTIVES        1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is          it given?        2. Is the introduction of trastuzumab in early breast cancer cost-effective for the          Netherlands?      To address the research questions (objectives), the following outcome measures will be     determined:      CLINICAL OUTCOME MEASURES        1. Actual trastuzumab administration as opposed to planned trastuzumab administration        2. Selection criteria for chemotherapy and trastuzumab in daily practice        3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac        4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab           ECONOMIC OUTCOME MEASURES        5. Volumes and costs of diagnostic tests and therapies including those for (distant)          relapse        6. Cost-effectiveness of trastuzumab in clinical trials versus in real world   "
106296|NCT01894685|"     Several studies indicate that mesalazine might have a preventive effect on recurrence of     adenomas in patients with and without inflammatory bowel disease. As mesalazine has limited     adverse effects, it is an attractive candidate for chemoprevention. In this study we aim to     investigate the antineoplastic properties of mesalazine in patients with sporadic colorectal     adenomas.   "
106297|NCT01894672|"     The purpose of this phase II study is to find out if an investigational drug called LGX818     can stop the melanoma from growing.   "
106307|NCT01894542|"     The investigators have previously shown the intact protein from cod filet improves glucose     homeostasis and serum lipid profile in overweight adults. A large amount of trimmings from     various fish species such as cod is thrown away or sold at very low prices for animal feed,     and analyses of the amino acid composition reveals that this can be a good protein source for     humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and     non-water soluble proteins. In the present study the investigators will compare these     fractions, by studying their effects on glucose homeostasis and inflammatory markers in     overweight/obese adults.   "
106298|NCT01894659|"     Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several     hundred procedures during their hospitalization. Many of these are tissue-damaging procedures     (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that     exposure to a single TDP can significantly increase ATP utilization and oxidative stress, as     evidenced by increased plasma levels of hypoxanthine, uric acid and malondialdehyde in     neonates exposed to TDPs as compared to controls (no TDP). Because neonates are exposed to     numerous TDPs, it is relevant to explore the energy costs of repeated exposures to painful     procedures, an important information that is currently not known, as the effect of this     cumulative metabolic dysfunction could result in potentially treatable or preventable cell     injury.      Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the     basis of its effect on behavioral and physiological pain scores. However, we found, through     our prospective, randomized, double blind study funded by NIH, that although oral sucrose     significantly reduced pain scores, its administration before a single TDP (heel lance)     significantly increased ATP utilization. This is evidenced by higher plasma concentrations of     hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no TDP, no     sucrose) or neonates just given a pacifier. These novel findings raise concern because     preterm neonates have limited ATP stores and are susceptible to cell injury due to ATP     depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose can     alter ATP metabolism, what are the effects of exposure to multiple doses of oral sucrose?     More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose dosages on     ATP utilization, oxidative stress and cell injury? This application will also explore the     effect of 30% oral glucose, another sweet solution currently used to relieve pain, on ATP     metabolism.      In this study, we will test the general hypothesis that exposure to multiple TDPs and/or     multiple doses of oral sucrose analgesia compared to oral glucose or standard care, alter     biochemical markers of ATP utilization, oxidative stress and cell injury. We will use a     prospective randomized clinical research design to test this hypothesis during days of life     3-7 of human premature neonates. Increased ATP utilization will be quantified by     concentrations of hypoxanthine, xanthine and uric acid measured using HPLC. Oxidative stress     will be quantified by concentrations of allantoin using gas chromatography/mass spectroscopy,     and cell injury will be quantified through urinary concentration of intestinal fatty acid     binding protein, an early marker of enterocyte injury. Data from this application will     provide insight into the cellular and biochemical effects of repetitive and accumulated TDPs     and/or multiple doses of oral sucrose. With this knowledge, we will propose and test     innovative strategies that will not only decrease pain but also will prevent cell injury or     cell death.   "
106299|NCT01894646|"     Currently, only three radiotracers, (2-[18F]FA, 6-[18F]FA and [18F]AZAN), are available for     studying α4β2-nicotinic acetylcholine receptors (α4β2-nAChR) in human brain using PET     imaging. A crucial problem for 2-[18F] FA, 6-[18F] FA and ([18F] AZAN is low binding     potential (BP) in extrathalamic (ET) regions, including hippocampus, cortex and caudate which     have lower receptor densities than the thalamus. The importance of imaging ET-α4β2-nAChRs     (ET-nAChR) has emerged from the post-mortem demonstration of altered densities of ET-nAChRs     (but not thalamic nAChR) in neurodegenerative diseases and schizophrenia. PET imaging of     ET-nAChR may prove to be useful in both detecting early changes and following functional     deterioration in neurodegenerative diseases such as Alzheimers disease. Furthermore, PET     imaging of ET-nAChR may allow investigation and development of new therapies acting on the     acetylcholine system.      The imaging drawbacks of the presently available nAChR radioligands have initiated the     development of radioligands with greater binding potential by several research groups. The     available pre-clinical data on our new radioligand [18F](-)-JHU86428 ([18F]XTRA) suggest that     this radioligand is superior to 2-[18F]FA for quantitative PET imaging of α4β2-nAChR (Gao, J.     Med. Chem, 2008). In baboon PET studies [18F]XTRA exhibits 200% greater brain uptake, 300%     higher BPs and reaches steady-state in approximately 1.5 h in cortical regions post-bolus     administration versus 6-8 h for 2-[18F]FA. In vitro binding assays shows greater binding     affinity of XTRA and similar nAChR-subtype selectivity in comparison with 2-FA. Both ligands     bind selectively with the β2-subtypes that are predominant nAChR subtypes in the mammal brain     and display little binding affinity at ganglionic α3β4-nAChR.      The current planned human protocol will be conducted to (1) determine brain distribution     (brain uptake) and test the reproducibility (in test-retest design) of [18F]XTRA brain PET     scans for validation of the radioligand; (2) generate estimates of the whole body and     internal organ radiation absorbed doses from exposure to single iv administrations of     [18F]XTRA in healthy human subjects; and (3) determine brain distribution of [18F]XTRA in     patients with Alzheimer's disease.   "
106300|NCT01894633|"     Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect     associate with increase the sensibility of Radiation through leakage of hidroliticenzimes,     increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative     stress in vitro. In this phase II study we evaluated the efficacy and safety as     radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation     (WBI)in patients with brain metastases (BM) from solid tumors.   "
106301|NCT01894620|"     This research is being conducted to study whether rTMS (repetitive Transcranial Magnetic     Stimulation) could be potentially used as a treatment for Alzheimer's disease. rTMS is a     technique that stimulates the brain by rapidly switching a magnetic field in a coil placed     over your head. Prior to rTMS, single pulse TMS will be used to localize the specific brain     region that we are interested in.   "
106302|NCT01894607|"     The goal of this clinical research is to learn how effective an ultrasound contrast agent,     called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both     kidneys.   "
106303|NCT01894594|"     The objective of this study is to assess the effect of alkali administration on bicarbonate     and potassium levels in patients with Sickle Cell Disease (SCD) and depressed serum     bicarbonate levels. The study is a prospective non-blinded evaluation of tolerability and     efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses of     escalating oral sodium bicarbonate treatment.   "
106304|NCT01894581|"     The United States has the highest prevalence of obesity among all countries surveyed in 2012     by the Organization for Economic Cooperation and Development. Maternal obesity is linked with     anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical     complications and congenital anomalies. Changes in reproductive hormones and diminished     oocyte quality have also been demonstrated. A gap of knowledge exists as the mechanisms     underlying these harmful effects are poorly understood and no specific treatments exist.      This proposal will test the hypothesis that dietary omega-3 fatty acids (FA) will improve the     output of hypothalamicpituitary- ovarian axis in obese women. The investigators will perform     paired assessments before and after supplementation in 10 obese and 10 normal weight women.     To test the pituitary and hypothalamic output, the investigators will examine the luteinizing     hormone (LH) and follicle-stimulating hormone (FSH) responsiveness during frequent blood     sampling. To test the corpus luteum function, the investigators will examine urinary     reproductive hormones (E1c, estrone conjugates, and pregnanediol glucuronide (Pdg)) over an     entire menstrual cycle. The investigators ultimate goal is to collect preliminary data for an     adequately powered randomized control trial.   "
106305|NCT01894568|"     The purpose of this study is to compare LY2605541 to insulin glargine in Asian insulin naïve     participants who have been treated with oral anti hyperglycemia medications. Participants     will receive 26 weeks of treatment.   "
106306|NCT01894555|"     This clinical trial is examining the effect of 4-week aspirin therapy on platelet     transcriptome in persons at high-risk for myocardial infarction or stroke due to family     history of early-onset coronary artery disease.   "
106333|NCT01894204|"     Forward-looking troop established(constituted) by the patients having been included in the     study  PADIS EP , PHRC on 2006 and 2009, randomized checked(controlled), double-blind,     comparing an anticoagulating treatment(processing) extended by coumadine versus placebo     during 18 months at patients having had a first episode of EP idiopathique treated(handled)     initially 6 months by anti-vitamin K.   "
106308|NCT01894529|"     Stroke is accompanied by local inflammatory response and systemic immunosuppression.     Immunosuppression markers are associated with the occurrence of medical complications     (infections), whereas inflammatory markers are associated with worse functional prognosis.      This prospective study tries to validate in acute stroke patients the prognostic usefulness     of a panel of immune biomarkers that have previously been associated with various clinical     outcomes.      The identification of beneficial and harmful immune responses in cerebral ischemia will allow     the prediction of the clinical course of the patients and will be helpful in designing     immunomodulatory therapeutic strategies for acute stroke.   "
106309|NCT01894516|"     -  280 patients suffering from active rheumatoid arthritis who have an inadequate response          to methotrexate will be evaluated for improvement of disease activity (efficacy) when          taking GLPG0634 as monotherapy (3 different doses - 50mg, 100mg and 200mg once daily) or          matching placebo for 24 weeks.        -  During the course of the study, patients will also be examined for any side effects that          may occur (safety and tolerability), and the amount of GLPG0634 present in the blood          (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of          action-related parameters in the blood (Pharmacodynamics) will be determined. Also, the          effects of different doses of GLPG0634 administration on subjects' disability, fatigue          and quality of life will be evaluated.   "
106310|NCT01894503|"     The purpose of this study is to assess the safety and performance of the steroid-releasing S8     Sinus Implant when used in post sinus surgery patients who present with recurrent sinus     obstruction.   "
106311|NCT01894490|"     Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with     high morbidity and mortality. In general, the patients are already malnourished, and early     postoperative enteral nutrition is recommended. However, there is no consensus concerning the     best enteral access route in these cases.   "
106312|NCT01894477|"     This phase II trial studies how well treosulfan, fludarabine phosphate, and total body     irradiation before donor stem cell transplant works in treating patients with myelodysplastic     syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine     phosphate, and total-body irradiation before a donor stem cell transplant helps stop the     growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted     cells from a donor can also make an immune response against the body's normal cells. Giving     tacrolimus before and mycophenolate mofetil after the transplant may stop this from     happening.   "
106313|NCT01894464|"     The Early Truancy Prevention Project is designed to prevent elementary school truancy through     teacher-led interventions that are individualized to meet student needs.   "
106314|NCT01894451|"     This research study is a pilot study, which tests the ability of an investigational compound     to be used in humans for further studies. Investigational means that 89Zr-bevacizumab for     PET/CT imaging is being studied. It also means that the FDA (U.S. Food and Drug     Administration) has not approved 89Zr-bevacizumab for PET/CT imaging for use in patients,     including people with your type of cancer.      89Zr-bevacizumab is a newly developed radiotracer. Radiotracers are compounds or drugs that     are attached to small amounts of a radioactive substance. The amount of the compound or drug     in a radiotracer is also very small. Radiotracers are used to make images of processes that     are happening in the body, but they do not affect how the body works. 89Zr-bevacizumab is     made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr).     89Zr-bevacizumab is used for an imaging procedure called positron emission     tomography/computed tomography (PET/CT). This radiotracer has been used in other research     studies. Information from those other research studies suggests that 89Zr-bevacizumab-PET/CT     imaging may be able to measure new blood vessel formation to determine where the cancer is in     your body and if your cancer is being killed by chemotherapy.   "
106348|NCT01894009|"     Background: Asymmetrical foot posture influences the pelvic girdle stability and might give     pain in the pelvic region. The objective was to investigate if foot manipulation to correct     foot asymmetry can relieve pregnancy related pelvic girdle pain (PPGP) and shorten sick leave     periods.      Design: Randomized single blinded (patients and evaluators) clinical trial comparing foot     with sham manipulation at 6 weekly treatment sessions.      Setting: Five physiotherapy out-patient clinics (10 physiotherapists) in Skaraborg Primary     Care, Sweden.   "
106315|NCT01894438|"     Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the     metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis and     non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver (liver     fat >5-10% of liver weight), not due to excess alcohol consumption or other causes of     steatosis.      At present, no medication or surgical procedure has been approved for treating NAFLD and     lifestyle modifications remain the cornerstone therapy targeting both at weight reduction for     overweight subjects and at prevention of overweight for the normal weight individuals. Given     that a Mediterranean dietary pattern has a beneficial effect both on the prevention and the     resolution of the metabolic syndrome, the main aim of the present study is to implement and     evaluate the potential benefits of an intervention based on the Mediterranean lifestyle in a     sample of patients with NAFLD.   "
106316|NCT01894425|"     The main objective of this study is to investigate the association between the presence of     HPV infection in one or both members of infertile/sub-infertile couples and the outcome of     pregnancies obtained by assisted reproduction.      The success of assisted medical procreation is defined as achieving a pregnancy resulting in     the birth of a living, viable child.   "
106317|NCT01894412|"     The purpose of this study is to compare the safety and pharmacokinetic characteristics of     HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous     injection   "
106318|NCT01894399|"     Study Design        -  Open, escalating single-dose design.        -  7 ascending dose cohorts        -  In each cohorts, subjects will receive a single dose of HM61713.        -  Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.   "
106319|NCT01894386|"     This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one     inhaler (at two different strengths of UMEC (125 and 62.5microgram [mcg]) and FF/VI     (ICS/LABA) and UMEC/VI (LAMA/LABA).      Subjects will receive each of the four treatments once, separated by a wash-out period of     7-21 days between doses in a four way crossover design. There will be 4 treatment periods in     total. During each treatment period, subjects will attend the clinical unit on Day -1 for     standard safety assessments in addition to familiarization with the inhaler. Each subject     will remain resident in the unit until at least 24 hours after the dose given on Day 1.     Following completion of all four treatment periods, a follow up visit will take place 7 to 21     days following the final dose of study medication.   "
106320|NCT01894373|"     to determine the therapeutic roles of CIK cells on patients with psoriasis   "
106321|NCT01894360|"     This will be a randomized, parallel-group, open-label, single-dose study of belimumab in     healthy subjects to estimate the relative bioavailability, tolerability and safety of a     single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects     using a prefilled syringe or autoinjector. This study will also assess the usability and     reliability of the injection devices. A total of approximately 80 subjects (40 per group)     will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0     milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned     injection device. Subjects will continue to be followed for 70 days after the administration     of belimumab.   "
106322|NCT01894347|"     Multi-Drug resistant pathogens (MDR) are reported worldwide with increasing incidence,     especially in intensive care settings.      One of the drugs which are effective against MDRs, is colistin (polymyxin E). This agent has     been reintroduced in response to the increase of MDR pathogens and might be used more often     in the future. Data on safety regarding the most important side effects are not sufficiently     available. l This study evaluates the toxicity in patients who receive aerosolized colistin.   "
106323|NCT01894334|"     The morbidity rate of Stanford A type Acute Aortic Dissection（AAD） has been increasing, about     5-10/100,000* per year. Emergency surgery has been the main treatment for Acute Aortic     Dissection, however perioperative mortality rate can be as high as 15~30%. Acute lung injury     (ALI) is one of the main complications that happen during the perioperative period, which by     itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries lack     researches on risk factors, pathogenesis, disease progression and outcome of ALI, which     happen during the perioperative period of Acute Aortic Dissection patients.      This topic study follow projects in the preoperative of Acute Aortic Dissection'surgery        1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac          tamponade and proximal high blood pressure)        2. ischemia - reperfusion injury of aortic dissection distal organ        3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder        4. systemic inflammatory response syndrome; use relevant clinical radiographic parameters,          indicators of respiratory mechanics (oxygenation index and lung injury index) and          biochemical indicators.      To discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and     observe their influences on the progress and prognosis of AAD, to explore early intervention     in the preoperative for possible risk factors and mechanisms and to evaluate their influences     on the prognosis, to achieve the purpose of reducing AAD perioperative mortality of ALI and     medical expenses.   "
106324|NCT01894321|"     Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in surgical     high risk patients. However, there has been no definite agreement of the additional     cholecystectomy in these patients. The investigators surveyed the clinical outcomes of the PC     in surgical high risk patients. And the investigators tried to prove the PC can be     appropriate and ultimate treatment for acute cholecystitis patients with critical illness     through this study.   "
106325|NCT01894308|"     This study is a continuation of previous studies done in healthy volunteers to prove the     efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series     of doses from low to high in men with low-to-no natural testosterone production to measure     their response to the varying doses. The results of this study will inform further studies     which will be longer in length, as to the starting doses. The study will be conducted in     London, U.K. at the Advanced Therapies Centre, The London Clinic.   "
106326|NCT01894295|"     The aim of this double blind clinical trial study is to investigate whether alphacalcidol     treatment in obese subjects can affect the resting metabolic rate. Moreover, the     investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated     receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α)     protein which may lead to change in metabic rate following treatment with either     alphacalcidol or placebo.   "
106328|NCT01894269|"     Although it is commonly accepted that antiviral therapy should be commenced before or during     hepatocellular carcinoma (HCC) treatment if the patients have high viral loads and elevated     ALT or total bilirubin values with signs of cirrhosis, the dilemma exists when HBV DNA and     liver function (such as ALT, AST, TBIL) remains low level. Whether antiviral therapy make     sense or not in these patients with no signs of hepatitis or high viral replication remains     unclear, especially for the relatively advanced stage HCC patients receiving TACE. Thus, the     investigators carried out this prospective control study to compare the survivals for     patients after TACE between with or without antiviral therapy.   "
106329|NCT01894256|"     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the     PK of olaparib in patients with mild or moderate renal impairment compared to patients with     normal renal function; Part B will allow eligible study patients continued access to olaparib     after the PK phase and will provide additional safety data.   "
106330|NCT01894243|"     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the     PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with     normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment     or normal hepatic function continued access to olaparib after the PK phase and will provide     additional safety data.   "
106331|NCT01894230|"     The purpose of this study is to examine if using genetics can improve statin adherence in     patients who should be taking statins but are not because of prior side effects. This study     will assist physicians/providers in making a personalized health care plan for prevention of     cardiovascular disease.   "
106332|NCT01894217|"     The purpose of this pilot study is to examine if using genetics can improve statin adherence     in patients who should be taking statins but are not because of prior side effects with     statins. This study will assist physicians in making a personalized health care plan for     prevention of cardiovascular disease.   "
109060|NCT01858480|"     To evaluate the safety and to determine the efficacy of D-ribose for the treatment of     congestive heart failure (CHF) in subjects who have been stabilized following hospitalization     with acute decompensation.   "
106334|NCT01894191|"     Interval (missed) cancers and lower than expected mortality reduction of proximal colon     cancers in the United States and elsewhere after screening colonoscopy drew attention to     quality indicators. Missed adenomas which are more likely to be in the proximal colon may be     contributing factors. An independent predictor of the risk of interval cancers is adenoma     detection rate. In pilot observations, the investigators showed that water exchange enhanced     adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized     controlled trial will compare water exchange with water immersion and traditional air     insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that     compared with air insufflation and water immersion, water exchange produces a significantly     higher adenoma detection rate in the right colon.   "
106335|NCT01894178|"     A recent article examined the use of Parker Flex-Tip tubes to standard ETTs for oral     fiberoptic intubation and concluded that there was a significant benefit in terms of     difficulty encountered when using the Parker Flex-Tip. The Parker Flex-Tip tracheal tube has     a flexible, curved, and tapered tip design different from traditional endotracheal tubes. The     design allows the tube to lie closely against the fiberoptic scope that is often used to     facilitate intubation, resulting in a smaller gap between the ETT and the fiberoptic scope.     This may allow the ETT to clear anatomic obstructions more easily. The patients they examined     had an average body mass index (BMI) categorized as normal weight. To our knowledge, there     have not been any studies that have investigated the use of the Parker Flex-Tube for     fiberoptic intubations in patients categorized as obese by BMI. Our hypothesis is that the     Parker Flex-Tip ETT results in easier passage of the ETT over a fiberoptic scope during     elective fiberoptic intubation of obese patients in comparison to a traditional ETT.   "
106336|NCT01894165|"     Phase 1 single dose study of ALXN1101 in healthy volunteers.   "
106337|NCT01894152|"     Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting     Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug     Administration (CFDA) on August 10th, 2011.      This prospective, observational, open-label, multi-center, single-arm, post-approval study is     designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a     cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in     real-world settings in China.      This study has no primary outcome measure. All observations are of equal weight.   "
106338|NCT01894139|"     The Nutrition Research Unit at Copenhagen University Hospital Herlev will during the fall     2013 initiate a randomized and controlled intervention study engaging 390 obese pregnant     women. The overall aim of APPROACH is to investigate how an optimal diet during pregnancy     influences the programming of the offspring. The children will after birth be included in a     prospective cohort according to maternal randomization and examined six times from delivery     until the age of nine years.   "
106339|NCT01894126|"     With the increased prevalence of cellular phones, mobile technology provides an important     tool to reach underserved populations in low to middle income countries. mHealth     interventions offer promise to improve maternal child health throughout the reproductive     health continuum if they contribute to increasing skilled birth attendance, family planning     and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of     using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on     uptake of reproductive and neonatal health services and maternal and infant outcomes   "
106340|NCT01894113|"     The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to     forceps biopsies to diagnose an interstitial lung disease   "
106341|NCT01894100|"     Limb length inequality is when a person has one leg that is longer than the other. This     research will look at correcting limb length inequality in adults with knee or hip symptoms.     This study will examine whether ways of measuring leg length inequality in the clinic are     valid and reliable, determine whether foot posture (flat foot, normal, and high arch) is     related to leg length inequality, and determine whether shoe lifts are a helpful treatment     for leg length inequality and knee/hip symptoms.   "
106382|NCT01893567|"     The aim of this study is to investigate the utility of a technological based rating scale for     assessing improvement in plaque psoriasis with Clobex spray treatment.   "
106342|NCT01894087|"     Unintentional poisoning is a developing public health problem in the U.S. Unintentional     poisoning (or overdose) deaths increased 157% among adults between 1999 and 2008. There     were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related     overdoses, particularly prescription opioid overdoses, have accounted for much of this     increase. There have been parallel increases in sales of opioids (with a 6 fold increase     between 1997 and 2007), as well as both medical and non-medical use of prescription opioids.     Prescription opioids are now among the most common of drugs used non-medically in the U.S.      The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription     opioid overdose prevention intervention. We will examine therapeutic alliance, perceived     satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on     precursors of overdose risk behavioral change immediately post-intervention. We will compare     intervention and control participants on knowledge, self-efficacy, readiness to change, and     behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects     on overdose risk behaviors six months post-intervention. We will compare intervention and     control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in     combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and     sedatives); and, 3) route of administration.   "
106343|NCT01894074|"     This is a study to determine whether a low calorie diet using meal replacement shakes     compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if     needed) will result in: 1) improvements in ability to ovulate and achieve pregnancy either     spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions in     waist and hip circumferences and improvements in hormones that are involved in allowing     pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose     (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and     physical well-being.      Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight     in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory     infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).   "
106773|NCT01888471|"     The purpose of this study is to evaluate antibody levels against Group B streptococcus in     mothers and the risk of developing invasive Group B streptococcus disease in newborns of less     than 6 days age as well as infants of age less than 90 days age.   "
106344|NCT01894061|"     NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the     FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma     multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields     within the human body using surface electrodes (transducer arrays). Intermediate frequency     electric fields (TTFields) stunt the growth of tumor cells.      The purpose of this study is to determine the efficacy of the combination of Bevacizumab and     NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients     with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.   "
106345|NCT01894048|"     The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to     keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be     required in order to gain control of asthma, and this is usually guided both by symptoms and     simple measurements of lung function such as peak flow.      The airways (breathing tubes) in the lungs get smaller the further into the lungs they go.     Most simple measurements of lung function only reflect the larger 'central' airways and don't     provide information on the smaller 'peripheral' airways.Newer measurements have been     developed that can now give us accurate information on how the smaller airways are     working.Indeed the small airways seem to play a significant role in asthma in terms of     inflammation and airway narrowing.      Recently, new types of steroid inhalers have been developed that have a much smaller particle     size than other standard inhaled steroids.These have been shown to go deeper into the lungs,     thus getting into the smaller airways. There have been a few studies suggesting that this     might improve asthma control. However, we do not know if when small airway function is shown     to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether     by improving small airway function specifically this translates into improved asthma control.      In this study we wish to study asthmatic patients who are not completely controlled on     standard particle size inhaled steroids, in addition to having evidence of abnormal small     airway function. By doing this we want to find out whether changing to the same dose of an     extra-fine particle inhaled steroid instead will improve asthma control by getting deeper     into the lungs and improving small airway function.   "
106346|NCT01894035|"     This pilot, non-interventional, company-sponsored, multi-center study documents observational     data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with     inhaled iloprost (using I-Neb device for the inhalation).      The planned study recruitment time is 18 months. The maximum follow up period in this study     will be 12 months.      The data will be collected from patients who have initiated the treatment mentioned above     (inhaled iloprost using I-Neb device) since February 1st, 2013.      Frequency of visits and procedures will be performed under routine conditions. The primary     objective of this study is to assess the compliance of patients with WHO/NYHA (World Health     Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension     treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.   "
106347|NCT01894022|"     This is an open label, long term extension to Study AMB115811. All subjects may remain in the     extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue     in the extension study until one of the following: the product is approved locally for use in     inoperable CTEPH patients; development for use in the CTEPH population is discontinued or     product is not approved by the local regulatory authorities; or the investigator decides to     discontinue the subject or subject decides to discontinue from the study. The primary purpose     of this study is to provide clinically relevant information on the long term safety of     ambrisentan in subjects with inoperable CTEPH.   "
106359|NCT01893866|"     The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg     pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant     administered as two separate 1 mL injections and to characterize the pharmacokinetics of the     new 30 mg strength.   "
106413|NCT01893164|"     The purpose of this study is to determine which is the best surgery to treat different     severity scales of cubital tunnel syndrome.   "
106349|NCT01893996|"     Rheumatoid arthritis patients are at increased risk of cardiovascular disease because of     systemic inflammation that can persist even in patients with well-controlled joint disease.     We hypothesize that adding an anti-tumor necrosis factor medication, adalimumab, to standard     non-biologic therapy for rheumatoid arthritis will improve endothelial function (reduce     cardiovascular risk) in these patients. The design of the trial is as follows: 18 month     prospective, randomized, double-blind crossover trial comparing the addition of adalimumab to     the addition of placebo. The primary endpoint is a change in endothelial cell function, as     detected by brachial artery FMD, at 6 months of adalimumab treatment compared to 6 months of     placebo.   "
106350|NCT01893983|"     The purpose of this study is to investigate health problems among rural Veterans. The     research project also aims to test a new telephone-based approach for helping Veterans who     need treatment connect with the appropriate care. This study will help us to better     understand the kinds of problems Veterans experience. The study will also help us to find     better ways to help Veterans get the help they may need.   "
106381|NCT01893580|"     Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has     led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer     diseases are after all still complex and potentially lethal.      Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise     to improve recovery after surgery in patients operated for lunge cancer with focus on     physical capacity and quality of life.      Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for     operation. Participation in this study is not possible if the participants by a doctor are     advised not to do strenuous exercise.      What does the study involve? The intervention consists of a combination of (1) exercise     before surgery and (2) exercise after surgery for lung cancer.        1. Exercise before surgery is a home-based exercise program is individually designed and          must be performed for at least 30 minutes every day until surgery. The home-based          exercise program varies in length due to number of days until surgery, and the intention          is not exceed 14 days.        2. The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks          rehabilitation program and three individual counseling sessions. Special needs in terms          of smoking cessation, nutritional counseling or patient education, this is also offered.          The exercise consists of individually prepared supervised strength - and fitness          exercise in a team, two sessions of 60 minutes/week.      What interventions will be compared? A home-based post-operative exercise program, combined     with exercise initiated two weeks after surgery, will be compared with usual care (exercise     initiated six weeks after surgery).      Will all participants receive the same treatment?      By draw it is decided which of the 4 groups the participants will attend to in the study:        -  Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two          weeks after surgery        -  Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after          surgery        -  Group 3: Rehabilitation initiated as early as two weeks after surgery        -  Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control          group) What are the possible benefits and risks of participating? There are no risks or          side- effects of participating other than muscle soreness and exercise is beneficial          when it comes to recover from an operation from lung cancer.   "
106351|NCT01893970|"     Mild traumatic brain injury (mTBI) is a prevalent and costly public health problem with     disabling consequences. More than one million civilians with mTBI are treated in US hospitals     and emergency departments each year (Faul, et al., 2010). While the exact number is debated,     approximately 10-15% of individuals with mTBI will experience prolonged and disabling     post-concussive symptoms (Stranjalis, et al., 2008; Ruff and Weyer Jamora, 2009), and 34%     will experience a psychiatric illness in the first year after injury (Fann, et al., 2004). In     addition, at least 188,270 military service members sustained a TBI from 2000 to mid August     2010, and nearly 77% of these injuries were mild (Defense and Veterans Brain Injury Center,     2010). Many individuals require treatment for resulting mTBI symptoms.      The proposed study builds on preliminary research conducted by the investigators to develop     and test the effectiveness of a social work delivered education and reassurance intervention     for adults with mTBI (SWIFT-Acute) against usual care. The proposed study will assess     acceptability and obtain preliminary effectiveness data for an enhanced social work     assessment and intervention for adults with mTBI (SWIFT) discharged from the Emergency     Department (ED). SWIFT includes early education, reassurance, coping strategies, resources     and a brief alcohol use intervention in the ED plus follow up telephone counseling, needs     assessment and case management referral to necessary services. The intervention targets     cognitive, physical, psychiatric and functional outcomes; specifically, post-concussive     symptoms, depression, anxiety, posttraumatic stress disorder, alcohol use, community     functioning and successful linkage to community resources.      It is hypothesized that SWIFT will be acceptable to patients and that participants in the     SWIFT group will report superior outcomes on measures of post-concussive symptoms, depression     and anxiety, alcohol use and community functioning and will report increased successful     linkages to needed resources when compared to the SWIFT-Acute group.      The specific aims of the study are:        1. Implement an innovative social work intervention for adults with mTBI (SWIFT).        2. Assess acceptability of SWIFT using qualitative interviews with participants.        3. Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or          prevention of post-concussive symptoms, depression, anxiety, posttraumatic stress          disorder (PTSD) symptoms, and alcohol use, and on improvement of community functioning          and successful linkage to community resources. 80 participants will be randomized to          receive SWIFT or SWIFT-Acute. Preliminary intervention effectiveness will be assessed          using standard measures of post-concussive symptoms, the primary outcome, depression,          anxiety, PTSD, alcohol use, and community functioning. A structured survey will be used          to assess linkage to community resources.   "
106352|NCT01893957|"     The aim of this study is to investigate the influence of electrical stimulation at the speed     of blood circulation and tactile sensitivity of the arms of women who underwent axillary     dissection for breast cancer.   "
106353|NCT01893944|"     To evaluate the influence of virtual reality and vibrational therapy in reducing pain     intensity secondary to breast cancer before and after application of treatment protocols,     through biomedical instrumentation.   "
106354|NCT01893931|"     The purpose of this study is to determine whether a phone call from a nurse within 1-3 days     after discharge from the Emergency Department (ED) decreases return visits to the ED/     hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary     outcomes, time to follow up appointment with physician and economic impact of this     intervention will be assessed.      Patients 65 years of age and older will be randomized following discharge from the ED into     one of two groups. Group 1(Intervention) will receive a phone call collecting information     about understanding of ED discharge instructions and guiding patient through the discharge     instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction     survey.      We hypothesize return visits to the ED and readmission to the hospital will decrease as a     result of the nurse phone call intervention.   "
106355|NCT01893918|"     Cigarette smoking, the major risk factor for Chronic Obstructive Pulmonary Disease (COPD),     causes systemic effects, such as systemic cellular and humoral inflammation, that could     substantially contribute to the development of chronic diseases, other than COPD, mainly     cardiovascular diseases and metabolic disorders. Such chronic comorbidities affect health     outcomes in COPD, particularly in terms of disease severity and prognosis. The aim of the     project is to investigate the prevalence of chronic comorbidities associated with COPD and     their impact on prognosis in elderly patients.   "
106356|NCT01893905|"     The main objective is to assess the efficacy of a new formulation containing chondroitin     sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary     osteoarthritis of the knee.   "
106357|NCT01893892|"     This randomized clinical trial studies levocarnitine in treating patients with     vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by     vismodegib.   "
106358|NCT01893879|"     This randomized clinical trial studies an investigational drug in preventing lymphedema in     patients at high risk after undergoing axillary lymph node dissection. The study drug may     prevent lymphedema in patients undergoing axillary lymph node dissection.   "
106360|NCT01893853|"     The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage     intake promotes fluid balance during exercise in the heat compared with water or placebo     intake.   "
106362|NCT01893827|"     The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of     XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 234     adults >18yo with alcohol dependence will be recruited from the community into treatment in     public sector primary care settings. The primary outcome which powers this study is a     dichotomous good clinical outcome defined by abstinence or moderate drinking, and as measured     by the Timeline Follow-back and analyzed using an intention-to-treat approach among all     randomized participants. Secondary outcomes include the incremental cost effectiveness of the     two arms, differences between arms by continuous measures of alcohol intake (drinks/day, %     days abstinent, time to first heavy drinking day, bio-markers), and the exploratory analysis     of factors possibly associated with effectiveness, including gender, prior treatment     abstinence, and mu opioid receptor (OPRM1) genotypes.      Specific Aim 1: Treatment Effectiveness. To evaluate the effectiveness of extended-release     naltrexone (XR-NTX) vs. oral naltrexone (O-NTX) in producing a primary good clinical outcome,     defined as abstinence or moderate drinking (<2 drinks/day, men; <1drink/day,women; and <2     heavy drinking occasions/month), during the final 20 of 24 weeks of primary care-based     Medical Management for alcohol dependence. Hypothesis: The rate of this good clinical outcome     will be approximately twice as great among participants receiving XR-NTX compared with those     receiving O-NTX.      Specific Aim 2: Cost Effectiveness. To estimate the incremental cost effectiveness of XR-NTX     vs. O-NTX,both in conjunction with primary care-based Medical Management. Hypothesis: XR-NTX     treatment will be more cost effective than O-NTX.      Specific Aim 3: Patient-Level Predictors of Effectiveness. To identify patient-level     characteristics associated with effectiveness in both arms.   "
106363|NCT01893814|"     To demonstrate benefit and tolerability of a probiotic product in infants with abdominal     discomfort.   "
106364|NCT01893801|"     The primary objective of this study is to determine the efficacy of nab-paclitaxel plus     cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma     (PDA).   "
106365|NCT01893788|"     The primary objective of this study is to determine which treatment will be more effective to     reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy     comparing aliskiren and eplerenone.   "
106366|NCT01893775|"     Background:      - Celiac disease is a condition where the immune system attacks the cells of the small     intestine. The intestine becomes inflamed and cannot digest food properly. The disease most     often causes a reaction to foods that contain gluten. Most people can treat celiac disease     with a gluten-free diet. However, some people have digestion problems even on a gluten-free     diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may     block the immune reaction that causes the disease. They will test this antibody in people who     have celiac disease that has not responded to a gluten-free diet.      Objectives:      - To see if antibody therapy is a safe and effective treatment for celiac disease that has     not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have been on a gluten-free diet for 6 to 12 months     but still have symptoms of celiac disease.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. These samples will help determine if the specific antibody treatment          is likely to work.        -  Before the start of the study, participants will have a biopsy of the small intestine.        -  Participants will receive three doses of the study antibody as injections. These doses          will be given 3 weeks apart.        -  Treatment will be monitored with blood tests and heart function tests. Participants will          also have a second small intestine biopsy within a week after the last dose of the          antibody.   "
106367|NCT01893762|"     Exercise induces innate immune response activation in athletes. The response starts during     exercise and lasts for approximately 24 hours. This innate immune response shows similarities     to the innate immune activation observed in, for example, bacterial infection and trauma.     Immediately after exercise, athletes develop leukocytosis and cytokine production is altered     towards an inflammatory pattern. However, to gain insight in immune response, a detailed cell     receptor expression is required. To investigate the physiological innate immune response to     exercise, we developed a model in rowers.      Aim: To determine the type and degree of cellular inflammatory response in peripheral blood     of elite rowing athletes after both anaerobe and aerobe exercise.      Study design:      Investigator driven, monocenter observational pilot study.      Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All     competitive rowing athletes.   "
106368|NCT01893749|"     The purpose of this randomized multiple-site clinical study is to determine whether a revised     CATCH-IT (Internet-based depression prevention program) is more effective than a general     health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It     is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or     maintain lower depressive scores over 2 years long-term follow up as compared to teens in     Health Education group.   "
106369|NCT01893736|"     The investigators will conduct an early postpartum professional breastfeeding intervention to     postpartum women who are intended to breastfeed newborn babies to improve breastfeeding     outcomes.   "
106370|NCT01893723|"     The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in     order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the     relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during     general anesthesia. The primary endpoint of this randomized multicenter study is to measure     whether there is a benefit to use the ANI in order to adapt remifentanil administration     during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of     patients presenting with at least one episode of hemodynamic reactivity, hypotension or     bradycardia in the ANI guided group vs control group ?   "
106371|NCT01893710|"     Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes     substantial morphological transformation, including progressive fibrosis, vasculopathy and     neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD     failure. In children, peritoneal biopsies demonstrating PD associated alterations have not     yet been obtained. They, however, should be particularly informative, since secondary tissue     and vascular pathology related to ageing or diabetes is absent.      An international, prospective peritoneal membrane biopsy study in children on PD will     therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on     occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at     time of renal transplantation. Quantitative histomorphometry and tissue protein expression     analyses will be correlated with time integrated PD treatment modalities and functional     characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter.     Blood will be obtained during clinical routine sampling. Biopsies will be obtained during     clinically indicated operations, without substantially increasing operation time and     associated surgical risks. The detailed histomorphometry of the PD membrane will give     additional information, potentially impacting on the individual PD regime.   "
106383|NCT01893554|"     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants     and children around the world. This study will evaluate the safety and immune response to a     RSV vaccine in two groups of participants: healthy children who have already had an RSV     infection (RSV seropositive) and healthy infants and children who have not already had an RSV     infection (RSV seronegative).   "
106384|NCT01893541|"     This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with     propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic     patients with high-risk varices.   "
106385|NCT01893528|"     This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to     assess the safety and tolerability of ascending single doses of REGN2009 administered to     healthy volunteers.   "
106386|NCT01893515|"     The objectives of this study is        -  To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood          lipids and lipoprotein parameters from baseline after 12 weeks of treatment.        -  To evaluate the safety of PRC-4016 as assessed by adverse events and other safety          parameters   "
106373|NCT01893684|"     The prevalence of obesity continues to increase at an alarming rate for all sectors of the     population in the US. Obesity in the older adult cohort is of great concern as it is     associated with reductions in mobility, declines in physical performance and increased risk     for physical disability. With regard to body composition, a) fat mass has been determined to     be a stronger predictor of mobility limitations than low muscle mass in older individuals and     alternatively, b) leg lean mass has also been cited as a primary determinant of lower     extremity physical function.      Obesity is related to increased levels of fatigue and lack of motivation and mental energy.     Fatigue can be categorized as both a subjective perception and a performance decrement.     Fatigue can be defined as a perceived lack of physical or mental energy while fatigability is     another construct categorized by the degree of fatigue associated with activity in any     dimension (i.e. physical, mental, emotional, and/or social).      The impact of a higher protein diet on muscle quality, muscle fatigability, perceptions of     fatigue and systemic inflammation in older adults has not been well documented. The utility     of a higher protein weight loss diet combined with resistance exercise training to augment     fat mass loss, attenuate lean mass loss and improve muscle quality and physical function     could potentially be of high value to overweight older women. The potential further benefits     of this regimen to enhance mental energy and other aspects of psycho-social well-being are     unknown.      The aims of the present study include assessing the effects of the proposed diet and exercise     intervention on 1) body composition, 2) strength and muscle quality, and 3) energy and     fatigue symptoms.   "
106374|NCT01893671|"     The primary goal of the study is to determine if Optical Coherence Tomography (OCT)     measurement of corneal power and astigmatism is more accurate than conventional Placido-ring     corneal topography. A second goal is to evaluate OCT-based epithelial thickness mapping. The     postoperative epithelial thickness variation will be used to calculate refractive effects and     calibrate the smoothing parameter in the mathematical model relating corneal mean curvature     and epithelial thickness. A third goal is to assess the repeatability of OCT measurements. A     fourth goal is to develop a method of estimating the focusing power, astigmatism, and HOA of     the crystalline lens based on measurements of the lens' anterior and posterior capsular     topographies and positions with the ultrahigh-speed MIT OCT prototype.   "
106375|NCT01893658|"     The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute     Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of     prednisone for treatment of drug-induced AIN. Currently there is no good treatment for     drug-induced AIN. Prednisone is the standard treatment but is associated with many     side-effects when used long-term and at high doses.   "
106376|NCT01893645|"     The measurement of blood hemoglobin (Hb) concentration is a routine procedure in pregnant     women. The assessment of Hb involves several steps, including a needle stick, blood     collection, blood sample analysis in the laboratory, and waiting for the results.      Pronto-7 (manufactured by Masimo, CA, USA) is a new portable device that allows a quick     bedside Hb spot check. A finger clip probe, similar to the standard oxygen finger clip probe,     provides hemoglobin values in less than 60 seconds.      In this prospective observational study the investigators will assess the clinical accuracy     of Pronto-7 derived Hb values compared to the gold standard laboratory Hb values in obstetric     patients. We will be calculating the mean difference between Pronto-7 and laboratory Hb     values. We plan to recruit 55 pregnant women admitted for vaginal or cesarean delivery at BC     Women's Hospital.   "
106377|NCT01893632|"     Benzodiazepine dependence is a growing public health problem for which very few     evidenced-based treatment approaches are available. Approximately 683,000 individuals met     past year criteria for sedative-hypnotic use disorders in the US during 2010, a prevalence     greater than heroin or methamphetamine dependence. The most commonly prescribed     sedative-hypnotic agents are the benzodiazepines. Chronic use induces pharmacodynamic     tolerance in the GABA neurotransmitter system and individuals with physiological dependence     find benzodiazepines difficult to discontinue because of withdrawal or rebound symptoms,     which include autonomic arousal, depression, anxiety, and insomnia. Available evidence-based     treatment approaches have been primarily directed at therapeutic users of benzodiazepines who     do not meet criteria for a substance use disorder, with a general consensus that the gradual     taper of benzodiazepines over a period of several months is the optimal approach. However,     patients with benzodiazepine dependence are typically referred for inpatient detoxification     treatment, which rapidly tapers patients off benzodiazepines. Protracted withdrawal symptoms     frequently persist after discharge, predisposing patients to relapse. More effective     pharmacotherapeutic strategies are needed for the treatment of benzodiazepine dependence in     the outpatient setting.   "
106378|NCT01893619|"     Observational study regarding the use of supplements in chronic fatigue syndrome patients   "
106393|NCT01893424|"     This project is intended to evaluate self-emulsifying drug delivery system termed     Piperine-Pro-Nano-Lipospheres (P-PNL) for enhancing the oral bioavailability of     tetrahydrocannabinol (THC) and cannabidiol (CBD).The oral bioavailability of these     cannabinoids is hampered by extensive first pass metabolism, resulting in relative     bioavailability of 6%.      The main goal of this study is to evaluate the bioequivalence of THC-CBD P-PNL product for     oral administration to Sativex® buccal spray, as measured by AUC 0-24h, Tmax and Cmax.   "
106379|NCT01893606|"     This study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and     safety of 1.1 chemical drugs N-acetyl glucosamine on Chinese IBS-D patients coming from four     centers in chongqing. 180 IBS-D patients in this research are accord with the Rome III     diagnostic criteria, screening/import period pain intensity scores of the NRS week mean value     are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over     2 days/week. Test cycle includes screening/import period (2 weeks), open treatment period (8     weeks), a double-blind placebo-controlled randomized withdrawal period (8 weeks), the main     outcome measures are pain intensity (NRS score 11 point scale) and stool type ( Bristol     type). And secondary endpoints included overall symptoms sensory scores, defecation     frequency, abdominal distension, mucous stool and quality of life parameters (IBS-36 scale).     After the end of the treatment period, the participants whose pain intensity and stool type     are effective subjects into a randomized withdrawal period, analysis and comparison of the     difference between treatment group and placebo group withdrawal rate and curative effect     index score reduces.   "
106380|NCT01893593|"     This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline     implementation in 32 clinical practices   "
106594|NCT01890798|"     This is a single arm, open-label continued access protocol of drisapersen for the treatment     of male subjects with Duchenne muscular dystrophy (DMD) having dystrophin mutations     correctable by drisapersen-induced DMD Exon 51 skipping. The purpose of this continued access     protocol is to offer pre-approval access to drisapersen for the treatment of subjects with     DMD who previously participated in eligible drisapersen studies. The protocol will collect     safety data required to assure subject safety and periodic efficacy data on muscle function.   "
106387|NCT01893502|"     Smoking cessation improves mortality, even in patients with existing smoking-related     morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an     important method to provide support to smokers and to improve quit rates, especially if three     or more calls were used in addition to face-to-face counselling. While it is reasonable to     assume that more counselling leads to better smoking cessation outcomes, little evidence     exists over the amount of telephone follow-up counselling that is required for optimal and     sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is     superior to one-month of weekly telephone follow-up.   "
106388|NCT01893489|"     Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not     yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal     mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis,     and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive     molecular imaging of carotid atherosclerotic lesion in PET.   "
106389|NCT01893476|"     Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem,     which is strongly related to smoking. Despite publication of guidelines on the prevention and     treatment of COPD, not all COPD patients receive the best available healthcare. Investigators     developed a tailored implementation strategy for improving primary care physicians' adherence     to COPD management guidelines. The primary aim of the presented trial is to evaluate the     effects of this strategy on physician's performance. The secondary aim is to examine the     validity of the tailoring of implementation interventions.      Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1     year will increase among participants assigned to the intervention group in comparison to     those assigned to the control group?      Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540     patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored     implementation program will be offered to general practitioners. Participating physicians in     the intervention practices (n=18) will receive training to provide brief anti-smoking     counselling. An additional form containing COPD severity scale will be inserted into     patient's medical records. The checklist with key information about the disease and its     management while consulting a patient with COPD will be provided to practitioners.     Investigators will provide practices with training inhaler devices for general practitioners     (GPs) to teach patients in correct use of each device and to note this education/training in     patient's medical records. The control practices will provide usual care.      Discussion: The results of this trial will be directly applicable to primary care in Poland     and add to the growing body of evidence on interventions to improve chronic illness care.   "
106390|NCT01893463|"     Early and effective control of severe bleeding is critical to survival of trauma patients.     The iTClamp™50 is a Health Canada approved medical device for temporary wound/skin closure     that quickly controls bleeding by sealing the skin. Similar to a clip, the device seals the     skin edges within a pressure bar, enabling the creation of a hematoma where blood collects     under pressure to form a stable clot until definitive repair. The iTClamp50 is indicated for     use as a skin closure device for short-term soft tissue approximation, including use in     trauma wounds, lacerations, junctional bleeds or surgical incisions. The purpose of this     prospective clinical study is to evaluate the effectiveness and safety of the iTClamp50 in     the ambulance (pre-hospital) and emergency department setting. This will be accomplished by     observing patients with the device applied from the pre-hospital through to patient     discharge. The hypothesis is that the iTClamp50 will be safe and effective at providing     temporary wound closure to control hemorrhage in the pre-hospital and emergency department     setting.   "
106391|NCT01893450|"     Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In     most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present,     the treatment is directed to identify vision threatening which requires aggressive     intervention, usually with glucocorticoids. For mild cases the treatment is limited to the     normalization of hyperthyroidism and support measures. Preliminary data show that     pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy     by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte     infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine     and pentoxifylline on the clinical course and quality of life of patients with mild to     moderate ophthalmopathy associated to Graves´disease.      Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution,     and naive to treatment were randomized to receive treatment during 12 months with either 1)     bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a     day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits     to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last     visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was     applied.   "
106392|NCT01893437|"     This single-center, randomized, double-blind, placebo-controlled, single dose study will     investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy     volunteers.   "
106927|NCT01886469|"     The main purpose of this study is to determine the rate and extent of absorption of one or     more modified release formulations of amphetamine (HLD100) in both adolescents and children     with ADHD.   "
106395|NCT01893398|"     Our previous findings support the notion that group activity program, based on cognitive     stimulation, recreational-occupational activities and physical-psychomotor exercises, can     lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD).      The purpose of this study is to clarify the efficacy of a rehabilitation program in     outpatients affected by AD in mild to moderate stages.   "
106474|NCT01892358|"     We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an     assessment-only condition (both groups receive rapid HIV testing, a review of testing     results, and brief HIV prevention counseling) among 350 injection drug users recruited during     an acute medical hospitalization at Boston Medical Center. In the general hospital setting,     injection drug users who otherwise might not seek care are accessible and teachable, and the     presence of a drug-related illness can set the stage for patients to be more receptive to     interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-,     3-, 6-, 9-, and 12-month(s) post-intervention.   "
106396|NCT01893385|"     The main objective is to assess the variation in plasma levels of cathelicidin before and     after influenza vaccination.      All bibliographic data suggests that supplementation vitamin D in the elderly often deficient     in this vitamin may have a double interest:        -  By induction of cathelicidin, assist in anti-infective response in particular to the          influenza virus        -  The normalization of vitamin D status, promote the return to an appropriate immune          response limiting excess inflammation and improving capacity to respond.      The entire project will collect new information on the merits of the use of vitamin D in     aging. A better knowledge of mechanisms involved and the impact of aging on them is a     necessary prerequisite the definition of a new strategy using this drug in the elderly     particularly fragile in order to improve its autonomy. This definition seems a sociological     interest obvious economic knowing the current aging population and its impact future of our     health system.   "
106397|NCT01893372|"     The goal of this clinical research study is to learn if eltrombopag can help to control MDS.     The safety of this drug will also be studied.   "
106398|NCT01893359|"     The objectives of this study are to evaluate the safety and efficacy, with regards to     regression of refractive outcome, as measured by manifest refraction spherical equivalent     (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK     followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin     Ophthalmic Solution), as compared to LASIK alone.   "
106399|NCT01893346|"     To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in     children from 3 months of age to <18 years.   "
106400|NCT01893333|"     To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize     the complication of radical hysterectomy and to maximize quality of life and to evaluate the     feasibility and efficacy by prospective randomized trial.   "
106401|NCT01893320|"     The goal of this clinical research study is to learn if the combination of vosaroxin and     decitabine can help to control AML or MDS. The safety of these drugs will also be studied.   "
106402|NCT01893307|"     The goal of this clinical research study is to compare the side effects of 2 radiation     treatments for head and neck cancer. The 2 treatments are intensity modulated photon therapy     (IMRT) and intensity modulated proton therapy (IMPT). Participants may also receive     chemotherapy along with radiation therapy.      IMPT is designed to use beams of proton particles to send radiation to the tumor. IMRT is     designed to use beams of photon therapy to send radiation to the tumor. Both of these types     of radiation treatment may give a full dose of radiation treatment to the tumor while not     damaging as much of the healthy tissue around it.   "
106403|NCT01893294|"     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in     treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such     as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing.   "
106404|NCT01893281|"     This study will evaluate if testosterone solution can raise testosterone hormone levels into     the normal range after treatment for up to 9 Weeks, in those participants with a documented     history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)]     when previously treated with a topical testosterone gel.   "
106405|NCT01893268|"     This prospective, observational study will assess the effectiveness and safety of Avastin     (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small     cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be     administered according to the treating physician. Data will be collected for approximately 4     years.   "
106406|NCT01893255|"     This observational study will evaluate the use and efficacy of RoActemra/Actemra     (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid     arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the     approved label will be followed for 6 months.   "
106407|NCT01893242|"     This randomized, double-blind, placebo-controlled study will evaluate the potential of     aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in     patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be     randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated     time on study treatment is approximately 3 years.   "
106408|NCT01893229|"     Background:      Bipolar disorder is one of the most common mental illnesses affecting 1%-4% of the     population, and one of the leading causes of worldwide disability. Mania is a condition of     excessively elevated mood, characterizes bipolar disorder, and usually is a main cause of     hospitalization. Mood stabilisers and antipsychotic drugs have long been the maintenance     treatment of acute mania with and without psychotic symptoms. Though clinical trails have     been demonstrated that these drugs are individually more effective than placebo in the     relatively long term (e.g 4, 8 weeks). However, in the pragmatic practice, patient at acute     mania urgently want to see the effectiveness, and psychiatrist under great pressure and are     in great need to evaluate the very short-term effectiveness (e.g one week). If the first     attempted antimanic drug fails, psychiatrist need the evidence that which medication should     be to added on or switch to.      Objectives:      one main aim is to rank the short-term ( e.g.one and two week) effectiveness and     acceptability of the common anti-mania drugs, including Lithium, Valproate, Oxcarbazepine,     Quetiapine, Olanzapine, or Ziprasidone. Secondary aim is to investigate which medication to     add on for non-responders or switch to.      Methods:      The study setting: it is expected that 120 subjects with a diagnose of DSM-IV bipolar I     disorder will be recruited from Guangzhou Psychiatric Hospital, the earliest psychiatric     hospital in the history of China established by Dr.J. G. Kerr in 1898.      Design:This study is a randomized, controlled trial. Participants with a Diagnostic and     Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar I     disorder, manic or mixed episode will be randomly assigned to a treatment of Lithium,     Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. In the following     conditions, participants will take another antimanic drug as a combination medication: 1)     those who have a reduction in YMRS scores less than 25% after one week of treatment; 2) those     who have a reduction in YMRS scores less than 50% after two weeks of treatment; or 3) those     who have a increase in YMRS more than 30% at day 4. An antipsychotic (Quetiapine, Olanzapine,     and Ziprasidone) will be added on for those who use lithium, Valproate or Oxcarbazepine as a     first attempted medication; while Lithium, Valproate, or Oxcarbazepine will be added on for     those who use an antipsychotic as a first attempted medication. Those participants who are     recognized as non-response/partial response to two combined medications after 6 weeks of     treatment will switch to Modified Electroconvulsive Therapy (MECT).      Measures: Primary outcome measures are change scores on the Young Mania Rating Scale (YMRS)     and dropout rates. Secondary outcome measures include Clinical Global Impressions (CGI)     Scale, Global Assessment Scale (GAS), Treatment Emergent Symptom Scale (TESS), and Brief     Psychiatric Rating Scale (BPRS).      Response criteria: <25% reduction in YMRS scores or >=4 scores of CGI is defined as     non-response. 25-49% reduction in YMRS scores from baseline as well as <=3 scores of Clinical     General Impression (CGI) is recognized as partial response.>= 50% reduction in YMRS as well     as 1 (very much improved) or 2 scores (much improved) of CGI is recognized as response.     Remission is defined as a YMRS score <=12 and CGI score equal to 1 or 2.   "
106409|NCT01893216|"     To investigate the prevalence of psychological symptoms and sexual dysfunction, and to     estimate their possible interactions in infertile men.   "
106410|NCT01893203|"     The aim of the study is to compare the efficacy of two photosensitizers,     methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the     treatment of facial actinic keratosis. We use randomized, double-blinded prospective study     design. The efficacy will be assessed clinically, histopathologically and     immunohistochemically.   "
106411|NCT01893190|"     Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety,     Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with     Aneurysmal Subarachnoid Hemorrhage   "
106412|NCT01893177|"     The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills     the EMA requirements for re-registration of influenza vaccines.   "
106414|NCT01893151|"     The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on     synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and     Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).   "
106415|NCT01893138|"     This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will     evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle Derived Cells     for Urinary Sphincter Repair (AMDC-USR) compared to a placebo (vehicle) control dose in the     treatment of stress urinary incontinence (SUI) in adult female patients.   "
106416|NCT01893125|"     To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain     experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after     three weeks of treatment compared to the baseline period.   "
106417|NCT01893112|"     African American women account for 66% of HIV infections in women in the U.S., AIDS is a     leading cause of death for African American women, and African Americans have the lowest     medication adherence rates compared to other groups in the U.S. One of the reasons for low     medication adherence among African Americans is fear of stigma. HIV stigma has been linked to     depression, psychological distress, poor quality of life, poor medication adherence and     service utilization contributing to morbidity and mortality. Research has found that stigma     is a moderator to poor adherence via depressive symptoms.      The current study is a randomized control trial with a time and attention control group to     test the effectiveness of a stigma reduction intervention adapted for use with African     American women. A total of 224 African American women will be recruited to participate in the     study. Half of the women will be from Chicago, Illinois (112) and the other half will be from     Birmingham, Alabama (112). A workshop will be held once a study site has recruited 28 women,     half of the women will be in the intervention group (14) and the other half will be in the     control group (14). Each study site will have 4 cohorts of 28 women.      The main aims of the current study are:        1. to determine the long-term effectiveness of the intervention to reduce stigma for          African American women living with HIV in Chicago Illinois and Birmingham, Alabama        2. to examine whether stigma reduction due to the intervention is associated with improved          physical health biomarkers (CD4+ T cell count, viral load), mediated by reduced          psychological symptoms (depressive symptoms), improved engagement to care, and improved          medication adherence        3. to explore whether stigma reduction due to the intervention is moderated by location          (Chicago vs. Birmingham), transmission risk factor, time since diagnosis, and perceived          social support      We expect that the multimedia workshop intervention will demonstrate effectiveness in     reducing internalized stigma through an easily-disseminated method, and that it will have a     positive impact on medication adherence and engagement in care for African American women     living with HIV.   "
106418|NCT01893099|"     The best way to combine a loco-regional procedure such as chemoembolisation or     radioembolization combined with an anti-angiogenic drug is not clear. This phase I trial aims     to establish, first, the tolerability of the combination of liver radioembolization with     SirSpheres® and sorafenib in uveal melanoma patients with liver metastasis studying different     schedules of administration of sorafenib after and before radioembolization. Secondly, we aim     to evaluate angiogenic markers modifications during these different schedules, either in the     serum or radiologicaly. Dose of Sorafenib will be 400 mg BID and the timing of introduction     will differ for one cohort to the other, given after the radioembolization for initials     cohorts and finally, before and concomitantly to radioembolization for the last cohort.   "
106419|NCT01893086|"     Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic     salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign     disease. However, the safety and the consequences regarding ovarian function after     salpingectomy have not yet to be established. Therefore, the aim of this randomized     controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between     laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.   "
106420|NCT01893073|"     The purpose of this study is to determine whether a mindful walking program is effective in     the treatment of patients with chronic low back pain.   "
106421|NCT01893060|"     Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care     Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can     occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs).     This study is a prospective, randomized controlled feasibility trial to evaluate three types     of hygiene products on umbilical line stumps, on the effect of line colonization and     subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be     randomized into one of four study groups, three products against standard of care (no     product). The three products that will be evaluated are currently being used in different     capacities for skin care in the University of Virginia (UVA) NICU. The study hypothesizes     that twice daily topical application of 1 or more antiseptic to the top of the umbilical     stump will decrease colonization of the umbilical stump while umbilical lines are in place.   "
106422|NCT01893047|"     A mother of a preterm infant listening to music while pumping her breasts will produce more     milk than a similar mother who is not listening to music. A mother listening to live music     will produce more milk than a mother listening to recorded music   "
106423|NCT01893034|"     Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone     results in the abutment of the femoral neck against the rim of the acetabulum. This gives     rise to localised cartilage damage and pain, but also increases the risk of developing     osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic     surgery versus physiotherapy and activity modification for the treatment of this condition.   "
106424|NCT01893021|"     The purpose of this study is to understand the family planning needs and practices of     postpartum Malawian women, with a focus on long-acting reversible contraception (LARC).      Hypotheses:        1. Postpartum women who are older, who have a history of unintended pregnancy, who do not          desire another child within 2 years, and who were counseled about LARC during their          pregnancy are more likely to have interest in using LARC.        2. Postpartum women who are older are more likely to be aware of LARC methods.        3. HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum          Malawian women who are HIV-.   "
106425|NCT01893008|"     The PREPARE study is the first multicenter randomized controlled trial to evaluate the     hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary     complications in patients undergoing esophageal resection.   "
106426|NCT01892995|"     This study will enroll patients presenting to the emergency department with acute suicidal     ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of     three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial     measurements will be made in the ED and at follow-up intervals.   "
106460|NCT01892540|"     This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or     PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical     imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or     PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing     clinical imaging or with newly diagnosed breast cancer.   "
106427|NCT01892982|"     The investigators' goal is to optimize the developmental outcomes of preterm infants by     preventing depression and improving functioning among their mothers during the critical first     year of life. The investigators are conducting a randomized controlled trial of a replicable,     lay-delivered intervention - the basic approach of which is to use an empirically-supported,     cognitive behavioral strategy to help mothers solve their unique daily problems and address     some of the predictable challenges to parenting a preterm infant.   "
106428|NCT01892969|"     Project Summary We propose an ancillary study to The Heart and Lung Failure Pediatric Insulin     Titration trial (HALF PINT), which is investigating the impact of normalizing blood glucose     using insulin infusions on clinical outcomes among children with hyperglycemia and heart and     lung failure. In this ancillary study, we will measure plasma levels of inflammatory,     coagulation, and fibrinolysis proteins and genotype DNA for polymorphisms among patients     enrolled in the HALF PINT trial. The results from this ancillary study will help us to     understand potential mechanisms through which normalizing blood glucose provides benefit,     which may lead to development of new therapeutic strategies in critically ill children   "
106429|NCT01892956|"     Categorization of glucose levels into 'healthy', 'pre-diabetic' or 'diabetic' is increasingly     seen as artificial. Furthermore, most micro and macrovascular complications may be present     already at the pre-diabetic stage.      Hyperglycemia, pre-diabetes and impaired glucose tolerance (IGT) are fully reversible, thus,     maintaining normal blood sugar levels is crucial for the prevention and control of diabetes     and the various other consequences of the metabolic syndrome. Only interventions that are     individually tailored can achieve proper glycemic control, and the glycemic index (GI), which     quantifies the glycemic response to particular foods, was developed for this purpose.      In this study the investigators will characterize the blood glucose responses and microbiota     of healthy individuals, aiming to assess the influence of food intake on gut microbiota and     the influence of gut microbiota on glycemic responses.   "
106430|NCT01892943|"     The objective of this survey is to establish the clinical course of vision loss and recovery     in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy     (LHON).      Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be     the main endpoint analysed.      The survey will collect historically documented visual acuity data for all patients at     participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria     apply. Patients are not required to attend the clinic for the survey.      Data will be collected in a completely anonymous manner. Ethical approvals and data release     agreements will be obtained as required by local regulations.   "
106431|NCT01892930|"     This pilot clinical trial studies stereotactic body radiation therapy in treating patients     with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able     to send x-rays directly to the tumor and cause less damage to normal tissue.   "
106432|NCT01892917|"     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring     coronary revascularization with Drug Eluting Stents (DES)   "
106433|NCT01892904|"     The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative     study (24-week treatment period).      The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended     regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of     primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation     period.      In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients     treated for one year will be investigated.   "
106434|NCT01892891|"     VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and     tolerable dose of VBY-036 in healthy volunteers. Volunteers will be randomly selected to     receive either a placebo or VBY-036 (30, 100, 300, 600 or 900 mg) once daily for seven days     in a row.   "
106435|NCT01892878|"     The purpose of this clinical study is to evaluate fusion of the facet joints in a prospective     cohort of patients utilizing the VerteLoc facet fixation device in patients receiving lumbar     laminectomy (L1-S1), without ancillary stabilization devices such as pedicle and transfacet     screws.   "
106436|NCT01892865|"     This study compares two different methodologies of scheduling cases in the operating room.   "
106437|NCT01892852|"     The purpose of this study is to evaluate whether acupuncture can be effective for     chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.   "
106438|NCT01892839|"     Hemodialysis keeps patients with renal failure alive but does not restore normal health.     Retention of chemicals that bind to plasma proteins and are therefore poorly removed by     dialysis may contribute to ill health in patients receiving conventional treatment. This     proposal will test the effect of a new method designed to improve the removal of     protein-bound solutes during dialysis. The effects on blood chemical levels of two different     dialysis prescriptions will be tested in patients already undergoing nocturnal in-center     hemodialysis three times weekly.   "
106439|NCT01892826|"     The rational of the study is to assess the pregnancy rate after the transfer of frozen     blastocyst in natural cycle controlled by external administration of hCG.   "
106440|NCT01892813|"     The project is designed to examine the effectiveness of strategies to increase access to     treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will     examine whether tailored treatment that is designed to address common comorbid conditions     that are related to cigarette smoking enhances success with quitting relative to enhanced     standard of care. The investigators hypothesize that participants assigned to the tailored     tobacco cessation intervention will report greater cessation rates at six months. The     investigators also anticipate more favorable outcomes on measures of depressive symptoms,     alcohol use, and body weight.   "
106441|NCT01892800|"     The purpose of this study is explore the impact of lung cancer surgery on the function of the     right side of the heart.   "
106461|NCT01892527|"     This is a single-arm, Simon 2-stage, phase 2 clinical study conducted in subjects with     advanced or metastatic colorectal cancer who have previously received ≥ 1 prior line of     systemic therapies and are resistant to EGFR inhibitor (cetuximab or panitumumab).      This trial will be conducted to determine objective response rate (ORR), progression-free     survival (PFS) and overall-survival (OS) of cetuximab plus tivantinib in patients with     wild-type KRAS CRC that is resistant to anti-EGFR antibody treatment (cetuximab or     panitumumab) and shows overexpression of cMET.   "
106442|NCT01892787|"     The airways in the lungs get smaller the further into the lungs they go. Most simple     measurements of lung function only reflect the larger 'central' airways and do not provide     information on the smaller 'peripheral' airways. Newer measurements have been developed that     can now give us accurate information on how the smaller airways are working. Indeed the small     airways seem to play a significant role in asthma in terms of inflammation and airway     narrowing. Recently, new types of inhaler formulations have been developed that have a much     smaller particle size than other standard formulations. These formulations have been shown to     go further into the lungs, thus getting into the smaller airways. In this study we aim to     compare the two extremes of available long acting beta agonists in terms of particle size     i.e. extra fine formoterol (Atimos) versus coarse particle salmeterol (Serevent)in asthmatics     with abnormal small airway function using a breathing test called impulse oscillometry. By     using this test we will be able to find out whether using an extrafine particle inhaler     improves small airway function.   "
106443|NCT01892774|"     This study would assess the impact of radio-frequency catheter ablation on exercise capacity     and quality of life in long-standing persistent atrial fibrillation (LSP-AF) patients   "
106475|NCT01892345|"     The primary objective of the study is to assess the efficacy and safety of eculizumab     treatment as compared to placebo in relapsing NMO patients using a time to first relapse     study design.   "
106595|NCT01890785|"     Compare the pharmacokinetic profiles when the contents are emptied into a soft food and     orange juice compared to the SPD489 when swallowed as an intact capsule.   "
106444|NCT01892761|"     Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney     transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to     post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to     tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the     full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7,     14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol.     Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both     groups but profiles were different according to the CNI regimen and time. The majority of     patients were underexposed to MPA on day 7 for both groups what reinforces the need of a     higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after     day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the     TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of     the patients were overexposed to MPA what indicates a time for MPA monitoring and dose     correction for long-term follow-up. These PK data suggest that changes in MPA profile occur     according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific     time-points.   "
106445|NCT01892748|"     The potential role of vitamin D on disease susceptibility, activity and severity has been     considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus     (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients,     especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE).      The objective of this study is to evaluate the effect of vitamin D supplementation     (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity     (clinical and laboratory parameters), fatigue and bone mass.   "
106446|NCT01892722|"     To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pedaitric     patients with multiple sclerosis   "
106447|NCT01892709|"     This is an exploratory, hypothesis-generating safety and efficacy study for patients who come     to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic pain     will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV hydromorphone     over a 4 hour period. Hydromorphone will be given as 1 mg increments based on how the patient     responds to the question, Do you want more pain medicine?. This question will be asked     repeatedly 30 minutes after the patient answers no or 30 minutes after the most recent dose     of IV hydromorphone (which occurs if the patient answers yes). Up to 10% (approximately 30     patients) will serve as a pilot at the start of the study.   "
106448|NCT01892696|"     The clinical usefulness of inspiratory flow pattern manipulation during mechanical     ventilation remains unclear. The aim of this study was to investigate the effects of     different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in     mechanically ventilated patients assessed by arterial pulse pressure variation (PPV) and     inferior vena cava distensibility.   "
106449|NCT01892683|"     This trial investigates the relationship between concentrations of the anesthetic drug     propofol in exhaled breath and blood in patients undergoing general anesthesia for elective     surgery. The main goal of this study is to develop a population pharmacokinetic model for     propofol in exhaled breath.   "
106450|NCT01892670|"     In a combat situation the need for safe and high-quality blood products is increasing. WB     (Whole Blood) is used in many trauma situations, but we wish to investigate whether there is     an even better whole blood product.      The purpose of this study is to examine the quality of leucoreduced, cold-stored whole blood.     We also wish to examine the effects of filtration of whole blood without a 1-2 hour     holding-time (warm-filtration) and the effects of forced filtration. We also wish to explore     the possibility of using cold-stored WB for production of RCC.      Analyses are performed with a main focus to investigate function and quality of red blood     cells and platelets.   "
106451|NCT01892657|"     This study examined the possible sensitization and irritation effects of a moisturizer with     sunscreen SPF 50+.   "
106452|NCT01892644|"     Hypothesis: Deferasirox can be used as a therapeutic agent to deplete the liver, heart and     bone marrow of excess iron in patients with iron overload caused by myelodysplastic syndrome     (MDS) and hemochromatosis (HC.      Assess the effect of new serum biomarkers (NTBI and hepcidin) and MRI as indicators of iron     overload and their usefulness to monitor iron depletion treatment.      Study the effect of iron overload and iron depletion on intracellular signal transduction,     trace metals concentrations in serum and urine and markers of oxidative stress in blood cells     and urine.   "
106472|NCT01892384|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 409306 in schizophrenic patients following oral administration of multiple low, medium,     and high doses over 14 days.      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI     409306 in schizophrenic patients.   "
106453|NCT01892631|"     Influenza morbidity and mortality cause a substantial financial burden to the NHS and to the     UK as a whole. Influenza vaccine is safe and effective but is required annually because the     circulating strain of virus changes each year. In the UK in 2012, the Chief Medical Officer     (CMO) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65 with     certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should be     vaccinated. While primary care practices are achieving these targets for elderly patients,     those set for younger patients with chronic conditions are not being met, with a third of     patients being missed in the 2011/12 flu season and with no substantial improvements in     uptake in the past decade. Therefore strategies to increase flu vaccine uptake in these     patients are required.      Previous trials have shown that patient reminders can increase vaccine uptake and in     particular, text messaging has shown to work in some populations in the United States as a     cheap, simple and effective reminder. However, whether the same is true in UK general     practice is unclear. The use of text messaging in the NHS for appointment reminders is also     increasing as it is cheap, quick and effective. Text messaging is already used in roughly 30%     of practices to remind patients about their flu vaccine but there has been no trial     addressing its effectiveness. Therefore, we propose a trial of a text messaging flu vaccine     reminder in patients aged under 65 who have a chronic condition. We hypothesise that     practices that send a text message will have increased flu vaccine uptake.   "
106454|NCT01892618|"     The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia     (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine,     Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms     of immune response.   "
106607|NCT01890629|"     To compare efficacy and safety of initial combination therapy of Gemigliptin versus     Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in     Patients With Type 2 Diabetes Mellitus.   "
106455|NCT01892605|"     Music has a long history in healing physical and mental illness. The Mozart effect was     initially reported by Rauscher, Shaw, and Ky in the journal of Nature in the year of 1993.     They examined performance on Stanford-Binet spatial tasks immediately following either 10     minutes of listening to Mozart's sonata K.448, silence, or instruction to relax. They found     the performance scores were 9 point higher in Mozart-listening group than other two groups.     Later, the beneficial influence of Mozart music on parkinson's disease, epilepsy, senile     dementia, and attention-deficit/hyperactivity disorder was reported. However, the real     neurophysiological mechanism of the influence remains unclear.      Epilepsy is a common disorder in the field of pediatric neurology. Although we had greatly     advanced in develop of new anticonvulsant, thirty percent of patients with epilepsy have     drug-resistance, which is associated with an increased risk of debilitating psychosocial     consequences. In addition, the adverse effects of anticonvulsants are not uncommon. Few     reports demonstrated that patients exposed to Mozart's music can significantly decrease in     seizure frequencies and interictal epileptiform discharge. However, the case number of these     studies was limited and the mechanisms of music therapy on epilepsy were not well known. In     our recent studies, Mozart's music indeed decreased the epileptifrom discharge in the     patients with epilepsy, particularly in the patients with generalized discharge and central     discharge. On the basis of these encouraging results, we will try to investigate the neural     mechanisms and clinical applications of music therapy in the following three years.      In the first year of our study, we use animal model to examine the possible mechanism of     Mozart's effect. The aim of the second year study is investigation the effect of music on the     cortical functions in the epileptic rat model. According to our previous study, Mozart's     sonata K.448 was effective in reducing epileptiform discharge. On the basis of previous     two-year results, the patients with epilepsy will be enrolled in the third year project to     perform an individualized music therapy. In this study, we can provide an alternative therapy     in the patients of epilepsy and investigate the possible biological mechanism of music     effect.   "
106456|NCT01892592|"     The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and     to reduce racial disparity in HTN control. To accomplish this, the investigators propose to     perform a cluster randomized controlled trial at the primary care provider (PCP) level and     including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the     HTN registry of which approximately 15,000 are black. The investigators will randomize all     PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally     tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with     pharmacotherapy. The Shake, Rattle and Roll trial is named for: 1) shake the salt habit;     2) rattle the intensity of current BP management; and 3) design the interventions with the     goal of being able to adapt and roll them out to community clinics outside of a managed     care system. Primary research question: whether a primary prevention intervention of either     diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than     usual care in improving rates of HTN control in blacks and thereby reducing disparities     between black and white. Primary aim: By implementing either intervention, the investigators     will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1     year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching     intervention or an intensified BP management protocol will result in an increase in HTN     control rate compared to usual care. Primary outcome: the proportion of patients with     sustained BP control at 1 year post-study enrollment.   "
106457|NCT01892579|"     Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and     irreversible neurodegenerative condition, affecting also close to 15 million family     caregivers (CG). A hallmark of the disease and one of the most significant challenges in     dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and     frequently occurring. It is associated with increased health care costs, reduced life     quality, heightened caregiver burden, disease acceleration and nursing home placement.     Treatment typically involves pharmacologic agents; however, these are at best modestly     effective, carry serious risks including mortality, and may not reduce family distress.     Recently issued position statements from medical organizations suggest nonpharmacologic     strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation     remain understudied. We propose a Phase III efficacy trial to test a novel 8-session     patient-centric intervention, the Tailored Activity Program. We will test the program using a     randomized two-group parallel design of 250 people with dementia (PwD) and their CGs (dyads)     who will be randomly assigned to received a program of tailored activities or a control     intervention of equivalent in-home attention and social contact. The trial assesses PwDs'     preserved capabilities, deficits, previous roles, habits, interests and home environment from     which activities are developed to match PwD profiles. Families are trained to implement     activities and modify them for future decline. Our primary study aim evaluates the effect of     tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored activity     program will have less frequent agitation compared to the control intervention condition.     Three secondary aims evaluate: 1) 6-month effects of tailored activities on agitation and     quality of life in PwD (Hypothesis: PwD receiving tailored activities will manifest lower     severity scores at 6 months and better quality of life compared to PwD in the control     intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG wellbeing,     and time spent providing care (Hypothesis: CGs receiving training in tailoring activities     will report enhanced wellbeing and less time caregiving compared to the control intervention     (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program expressed as an     incremental cost outcome achieved in the form of CG burden reductions and willingness to pay     for burden reductions (3 and 6 months; Hypothesis: Tailoring activities will be cost     effective compared to the control intervention at each test occasion). Exploratory aims will     evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if     effects differ by cognitive status, if CGs receiving the tailored activity program will use     activities at 6 months and with what frequency, how time gained is spent, and if     frequency/duration of treatment and activity use affects outcomes. If proven efficacious and     cost effective, the Tailored Activity Program has potential to transform clinical practice by     offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial     addresses a critical clinical need and public health priority identified by recent     legislative activity.   "
106458|NCT01892566|"     Investigators propose to develop methods to improve early identification of acute     exacerbations of COPD (AECOPD) among HIV-infected individuals. Investigators hypothesize that     earlier identification of acute exacerbations through in-home monitoring of respiratory     symptoms, lung function and medication usage will allow appropriate intervention to reduce     the morbidity associated with AECOPD. Therefore, the investigators propose using innovative     mobile health (mHealth) applications to Respond Early to Acute exacerbations of COPD in HIV     (mREACH). COPD is a co-morbidity of HIV with growing recognition, but remains greatly     under-recognized among HIV-infected persons. In this application, among HIV-infected     individuals with spirometry-confirmed COPD, investigators will conduct a pilot randomized     trial of mHealth monitoring compared to usual care to reduce the symptom and clinical burden     of AECOPD.   "
106459|NCT01892553|"     Dyspnea is a frequent, mostly unpleasant and long-lasting, but also often undertreated     symptom. Transcranial direct current stimulation (tDCS), a new non invasive method to modify     brain activation has shown good efficacy in the treatment of pain especially in the clinical     context. Given the fact that dyspnea has many common characteristics with pain, especially     concerning the brain areas involved in its central processing, we hypothesize that tDCS may     also modify the perception of dyspnea. In order to test this, we first shall determine     whether tDCS has a significant effect on acutely induced dyspnea in healthy volunteers. In     case of promising results of this pilot study, the next step will be the evaluation of the     benefit of tDCS in patients with severe dyspnea.   "
124395|NCT01657487|"     This study is to investigate and compare treatment efficacy with high and medium dose of     fluticasone in combination with salmeterol in COPD patients.   "
106476|NCT01892332|"     Epidural lidocaine is widely used in anesthesia for urologic or lower abdominal surgery     because of its rapid onset. But the epidural anesthesia using high concentration of lidocaine     may cause excessive motor block and unwanted side effects such as nausea, vomiting and     hypotension.      This is a study to determine the effective concentration of lidocaine with fentanyl in lumbar     epidural anesthesia for transurethral resection of prostate in elderly patients.   "
106477|NCT01892319|"     This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy     Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with     diabetes mellitus.   "
106608|NCT01890616|"     In this research study the investigators want to learn more about gut transit times in     Duchenne Muscular Dystrophy (DMD) patients over 18.      The investigators hypothesized:        1. DMD patients will exhibit prolonged gut transit times when compared to the general          population;        2. Abnormal transit times will correlate with increased age and worsening functional          status.   "
144084|NCT01398449|"     Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer     after esophagectomy and with pathological stage of T1-2,N+,M0?   "
106462|NCT01892514|"     Femoral head avascular necrosis is a relatively common disease (10,000 - 20,000 yearly new     United States of America cases) characterized by ischemic cell necrosis in a hip proximal     epiphysis area frequently requiring total Hip Arthroplasty (THA).      Even though THA resolves symptoms and restores good joint function, young patients are prone     to major disabilities and require prosthesis revision surgeries.      In this clinical trial a comparison between two groups of patients, treated with the same     procedure but with two different regenerative techniques, will be performed:        1. 52 patients with necrosis in an early stage, without deformity of the femoral epiphysis          (stage 2A-B-C in Association for Research on Osseous Circulation (ARCO) classification,          will undergo wide decompression of the necrotic area and reconstruction with homologous          Lyophilized Bone Chips (LBC), growth factors from platelet concentrate Platelet-Rich          Fibrin (PRF) and Concentrated Bone Marrow (CBM).        2. 52 patients with necrosis of similar features, without deformity of the femoral          epiphysis, will undergo wide decompression of the necrotic area and reconstruction with          Demineralized Bone Matrix (DBM), growth factors from Platelet-Rich-Fibrin (PRF) and          Concentrated Bone Marrow (CBM).      Patients will be evaluated post-surgery at 6 weeks, 3, 6, 12, and 24 months to assess joint     damage evolution by ARCO classification, and hip function by clinical scores (Harris Hip     Score (HHS), Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score, and     Visual Analogic Scale (VAS)).   "
106463|NCT01892501|"     Impact of screening nodes mediastinal by PET, at different times of the management of cancer     disease, remain unclear.      Benefits of combined PET and puncture with echoendoscopy for the diagnosis subsequent     therapeutic management should be evaluated in these different contexts.      We would like to demonstrate the clinical utility of this association to replace more     invasive diagnostic procedures and to assess the impact of the puncture on a possible     modification of the therapeutic management.      It is a single center prospective diagnostic assessment   "
106464|NCT01892488|"     The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the     development of antibiotic resistance in the community. The primary objective of ABACOPD is to     demonstrate in a sufficiently sized clinical study that there is no relevant increase in the     failure-rate for patients with acute moderate exacerbations of COPD (AE-COPD) treated with     placebo instead of antibiotic treatment both on top of standard of care. A patient is     classified as treatment failure if additional antibiotic therapy is required during treatment     period or until the test of cure visit (TOC at day 30, primary endpoint).   "
106465|NCT01892475|"     The purpose of this study is to test the overall effects of incentives on physical activity     among older taxi drivers, and whether mental accounting exists in this context.   "
106466|NCT01892462|"     The purpose of this study is to determine whether levels of inflammatory markers in     circulating blood can correlate with risk for dangerous heart rhythms. Patients with systolic     heart failure, which has been shown to increase risk for dangerous heart rhythms, will be     enrolled. All subjects will have an implantable cardioverter-defibrillator (ICD) in place,     which allows regular evaluation of heart rhythm.   "
106467|NCT01892449|"     The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the     potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous     studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics     and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E     ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing     robot-assisted laparoscopic radical prostatectomy.   "
106468|NCT01892436|"     This study is designed as a 3-year extension to the phase III core study CAIN457F2306. It     aims to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for     subjects who completed the core study CAIN457F2306, to obtain further long term efficacy,     safety and tolerability information in subjects with active psoriatic arthritis receiving     secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects will     complete the assessments associated with the core study visit and will subsequently continue     in the extension study on the same dose that they were receiving during the core study. The     regular assessments of disease activity will ensure that subjects who are experiencing     worsening of disease in any of the treatment groups can exit the study upon their own wish or     based on the advice of the investigator at any time.   "
106469|NCT01892423|"     Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily     Advance to induce sensitization to the skin   "
106470|NCT01892410|"     Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer     or irritant in certain individuals.   "
106471|NCT01892397|"     The purpose of this study is to find out what effects, good or bad, the Optune device has on     the patient and meningioma. This study is being done because currently there are no proven     effective medical treatments for a progressive meningioma that has failed surgery and/or     radiation. The study uses an experimental device called Optune. Optune is experimental     because it has not been approved by the U.S. Food and Drug Administration (FDA) for this type     of tumor, although it has been approved for a different type of brain tumor.   "
106473|NCT01892371|"     The goal of the Phase 1 part of this clinical research study is to find the highest tolerable     dose of AC220 (quizartinib) that can be given with either 5-azacitidine (azacitidine) or     cytarabine to patients with AML or MDS.      The goal of the Phase 2 part of the study is to learn if quizartinib with either azacitidine     or cytarabine can help to control AML or MDS. The safety of these combinations will also be     studied.   "
106609|NCT01890603|"     Cluster randomized controlled trial comparing care coordination incentives to pay for     performance (quality measure) incentives in clinics on utilization, cost, quality, and     patient experience.   "
107085|NCT01884415|"     The objective of this clinical trial is to compare the response rate obtained with two     different vaccination schemes against HBV in cirrhotic patients. These patients must be     candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml)     after three intramuscular doses of 40 µg.   "
106478|NCT01892306|"     The specific goal of this research study is to investigate the feasibility, acceptability,     and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed     specifically to target common core processes across mood and anxiety disorders [Unified     Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of     patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare     treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the     UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month     period and will be assessed monthly to track changes in mood, anxiety and emotion-related     symptoms; functional impairment; and relapse rates. Data on the acceptability of the     treatment will be gathered concurrently through monthly patient self-reported ratings of     treatment satisfaction, and by tracking rates of acceptance for randomization into the study,     number of completed sessions, and dropout rates. The study will examine: 1) whether combined     cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable     and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid     anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater     symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether     treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a     6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and     functional impairment are mediated by changes in emotion regulation skills. The broader aim     of this study is to address the need for improved treatments for bipolar disorder.   "
106479|NCT01892293|"     This study will enroll patients with multiple myeloma who have received prior therapy for     their disease but their disease has progressed or relapsed.   "
106480|NCT01892280|"     The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set of     psychoeducational materials for teens with type 1 diabetes and (2) text message reminders to     check blood glucose levels can help improve blood glucose levels in teens with type 1     diabetes.   "
106481|NCT01892267|"     Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube     (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration     rate, and lower rates of short- and long-term complications when compared to standard PEGJ     feeding tubes.   "
106482|NCT01892254|"     This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS)     before and after removal of their insulin resistance by metformin.      The investigators' hypothesis is that insulin resistant women with PCOS have a reduced     incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance     test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be     improved when their insulin resistance is removed.   "
106483|NCT01892241|"     Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept     peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.   "
106484|NCT01892228|"     The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to     decrease mortality related to HIV.      The study's proposed mechanism of decreasing mortality rates is to shorten the time between     initial HIV screening and ART implementation to within two weeks.      The study population consists of participants who received an initial HIV infection diagnosis     within the study period. Medical institutions will provide one-stop services by following     detailed guidelines regarding reporting of positive HIV antibody screenings, further testing     procedures, and treatment referrals in accordance with a pre-determined timetable. In     addition, additional strategies focusing on policy development, medical personnel training,     and a broad general public education campaign will be implemented.      Main assessment measures are HIV-related mortality rates, treatment coverage, or other health     outcomes.   "
106485|NCT01892215|"     Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of     the increase in the rate of cesarean section, any procedure that could help reduce blood loss     during cesarean section should be investigated. The purpose of this study was to compare 2     methods of blunt expansion of the uterine incision at the time of cesarean delivery:     transversal vs. cephalad-caudad.   "
106486|NCT01892202|"     This multicenter observational study will evaluate the efficacy and safety of Mircera     (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on     dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic     renal anemia according to the standard of care and in line with the current local label will     be followed for 6 months.   "
106487|NCT01892189|"     The purpose of this study is to determine whether ketamine-induced brain activity changes are     modulated by TAK-063 administration using neuroimaging battery tests.   "
106488|NCT01892176|"     The investigators hypothesise that measuring biomarkers of oxidative damage could better     inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD     subjects.   "
106489|NCT01892163|"     Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg     Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical     coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular     edema.   "
106490|NCT01892150|"     Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen.     However, there is no histologic study about the effects of anti-inflammatory and     anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.   "
106569|NCT01891123|"     As cytotoxic agents, DTX and PTX have a narrow therapeutic window. BSA dosing leads to great     inter-individual PK variability, which is a major contributor for severe toxicity, especially     in East-Asian populations. DTX exposures measured by area under plasma concentration-time     curve (AUC), PTX exposures measured by the time above a plasma concentration of 0.05 µmol/L     (TC>0.05), are the most biologic effects associated PK parameters for DTX and PTX,     respectively, which could positively predict related toxicities such as neutropenia,     peripheral neuropathy, etc. So, we conducted a randomized clinical trial to compare the     effect on related toxicities and efficacy of PK-guided dosing strategy and BSA dosing     strategy.   "
106493|NCT01892111|"     Obese women experience increased infertility rate and longer time to conception showing lower     pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss     improves not only spontaneous pregnancy rates but also those of assisted reproductive     techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle intervention     programs consisting in hypocaloric diet and increased physical activity, whereas very little     is known about the specific effects of physical activity alone on human reproduction.      In a previous retrospective study, we demonstrated that physical activity enhances the     reproductive performance of obese infertile patients who receive in vitro fertilization (IVF)     and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss.      The aim of this randomized controlled trial (RCT) will be to evaluate if a structured     exercise program improve the effectiveness of ARTs.   "
106494|NCT01892098|"     The purpose of the study is to determine the effects of zinc supplementation on bone growth     over four weeks. Participants will agree to attend two visits to our laboratory and at each     will complete blood and urine samples, questionnaires related to diet and physical activity     and will receive a bone scan at the first appointment.   "
106495|NCT01892085|"     Compelling evidence exists that breast milk helps protect very premature infants from     prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit     delayed lactogenesis stage II (when the milk comes in) and decreased breast milk     production. Several studies have linked earlier initiation of breast milk expression     following delivery with a greater milk production. However, none conclusively determined the     optimal timing of breast milk expression. As a result these mothers continue to struggle with     inadequate breast milk production. This study will follow 180 mothers of premature infants     for 6 weeks following delivery to test      Earlier initiation of breast milk expression following delivery is associated with (1) an     earlier lactogenesis stage II, (2) greater volume of breast milk production during the first     6 weeks, (3) improved short-term infant health outcomes and (4) women who deliver at an     earlier gestation will have decreased milk production and a later lactogenesis stage II.     Following stratification according to the gestational age of the infant (23-27 weeks vs.     28-32 weeks), eligible women will be randomly assigned to one of three groups and instructed     to start mechanically expressing their r breasts, either in the first hour, 1-3 hours or 3-6     hours following delivery. The timing of lactogenesis stage II will be documented, and the     volume of breast milk produced will continue to be measured for the first 6 weeks following     delivery and at discharge. Infant nutritional outcomes will be measured throughout the 6-week     study. The impact of the differences in timing of initiation of milk expression following     delivery on timing of lactogenesis stage II, milk volume, short term nutritional outcomes,     amount of breast milk feedings at discharge, and impact of gestational age on milk volume and     lactogenesis stage II will be determined.   "
106496|NCT01892072|"     The investigators study the VEGF signaling in HCC cell lines and its mechanism in HCC growth,     proliferation and apoptosis.   "
106497|NCT01892059|"     The purpose of this study is to compare the efficacy and safety of the segmental artery     clamping and main renal artery clamping during laparoscopic partial nephrectomy   "
106498|NCT01892046|"     Heat shock protein 90 (Hsp90) is a chemical in the body that is involve in the promotion of     cancer. SNX-5422 is an experimental drug that blocks Hsp90.   "
106499|NCT01892033|"     The overall aim of this pilot feasibility study is to determine if 12-week moderate intensity     exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans.      Specific aims of the study are to;        1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity          exercise        2. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome          data will include posttraumatic and depressive symptoms.        3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on          comorbid pain syndrome and quality of life.   "
106500|NCT01892020|"     This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and     safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50     (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2     diabetes mellitus.   "
106501|NCT01892007|"     A double-blind randomised active-controlled trial aims to assess whether Cogmed (adaptive)     working memory training results in improvements in untrained measures of cognition, speech     perception and self-reported hearing abilities in older adults (50-74 years) with     mild-moderate hearing loss who are existing hearing aid users, compared with an active     placebo Cogmed (non-adaptive) control. It is hypothesised that improvements on trained Cogmed     tasks, representing increased working memory capacity, will result in improved performance on     cognitive and speech perception tasks that engage working memory. We also measure     self-reported hearing ability to assess self-perceived benefit of Cogmed training.   "
106502|NCT01891994|"     Background:      - Eltrombopag is a drug being tested for treating severe aplastic anemia. It can help improve     blood counts in these patients. However, researchers do not know how long the drug can and     should be taken for this type of anemia.      Objectives:      - To look at whether 6 months of treatment with eltrombopag can improve patient s blood     counts.      Eligibility:      - Individuals at least 2 years of age who are taking eltrombopag for severe aplastic anemia.      Design:        -  Participants will take eltrombopag by mouth once a day for 6 months.        -  Blood samples will be collected every 2 weeks for the first 6 months. Bone marrow          samples will be collected at 3 and 6 months. These samples will look at the effects of          the study drug on the marrow.        -  Participants will continue to take the study drug for as long as it is effective and if          the side effects are not severe.   "
106503|NCT01891981|"     The goal of this clinical research study is to find the highest tolerable dose of moxetumomab     pasudotox that can be given to patients with relapsed and/or refractory ALL.   "
106504|NCT01891968|"     The goal of this clinical research study is to learn if bortezomib can help to control MDS.     The safety of this drug will also be studied.      Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer     cells to die.   "
106554|NCT01891318|"     This Phase I/II trial studies the ability to stop brain metastases from coming back after     treatment with radiosurgery followed by surgical resection. It will also evaluate the side     effects of these combined treatments and help determine the best radiosurgery dose.     Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal     tissue in the brain.   "
106505|NCT01891955|"     The purpose of this study is to compare two healthy diets (according to official Spanish     guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order     to see if one is better than the other.      Another goal is to test the hypothesis that food choice has metabolic effects that are     independent of macro/micronutrient composition, fiber content, glycemic load and weight loss     in the treatment of type 2 diabetes.   "
106506|NCT01891942|"     The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw     Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger     threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold     for healthy subjects and COPD patients.   "
106635|NCT01890265|"     To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of     FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in     these subjects.   "
106507|NCT01891929|"     This study, driven on schizophrenic patients, is aimed at :        1. Measuring the efficiency of the cognitive remediation program RECOS (COgnitive          REmediation in Schizophrenia) on the capacity of the patients suffering from          schizophrenia to improve the integration in sheltered employment (ESAT and EA).        2. Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to          the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on          integration in sheltered employment of patients suffering from schizophrenia.        3. Realizing a comparative analysis, in both arms, of :             1. the number of working hours achieved in sheltered environment during the 6 months               following the two programs (reported to the working time planned by the contract of               employment)             2. the duration of such employments in sheltered areas.        4. Estimating the impact of RECOS on the neuropsychological variables, the symptomatology,          the consciousness of the disorders(insight), the quality of life and the social autonomy          before the treatment (month M0), at the end of the treatment (month M3), and 6 months          later (month M9), and looking for a correlation between the improvement of these          parameters and sheltered employment.        5. Estimating the impact of cognitive remediation on integration in sheltered employment.   "
106508|NCT01891916|"     Food allergy (FA), defined as an adverse immune response to food allergens, is among the most     frequent allergic disorders in childhood and it has recognized as a major paediatric health     problem due to the severity of the reactions and the dramatic increase over the past decades.     Cow's milk allergy (CMA) is the most frequent FA in children worldwide, and it has been     demonstrated that it could be the first manifestation of the so-called atopic march,     characterized by the occurrence of other allergic disorders in the subsequent years after the     onset of CMA. In a previous study, involving children with CMA over a period of 5 years, 40%     developed asthma, 21% atopic eczema, and 43% allergic rhinitis. Similar results have been     reported in a recent study on Finnish children Intestinal microflora appears to have a     crucial role in the development of atopic disorders. Children with atopic diseases have     different commensal bacterial groups in the gut compared to non-atopic children, and     differences are also found between countries with high and low incidence of atopic diseases.     There is currently great interest in manipulating the normal microbiota to accrue health     benefits through an approach known as probiotics. Probiotics are defined as live     microorganisms which when administered in adequate amounts confer a health benefit on the     host. The conceptual basis of possible use of probiotics in the prevention and treatment of     atopic disorders is well grounded. Lactobacillus GG (LGG) is the most studied probiotic in     the prevention and treatment of atopic disorders. Wide and well-designed clinical studies     have provided several evidences on the efficacy of LGG as preventive or therapeutic strategy     in pediatric atopic disorders. More recently, in vitro studies have provided evidences on the     potent immunoregulatory role and on the influence on intestinal microflora composition     (toward a more beneficial composition in the prevention and treatment of atopic disorders)     elicited by LGG. This view has been further reinforced by recent research showing that LGG is     able to improve recovery of intestinal symptoms in infants with CMA-induced allergic colitis.   "
106509|NCT01891903|"     TO TRANSALETE AND VALIDATE DE TORONTO PSORIATIC ARTHRITIS SECREENING QUESTIONAIRE INTO     SPANISH   "
106510|NCT01891890|"     Seizures that arise in specific areas in the brain are called Localization Related Epilepsy     (LRE) and are the most common seizure disorder in children. Children that receive drug     treatment for this disorder may suffer from treatment related side effects which impact their     ability to think or concentrate and their ability to interact socially. These negative     treatment effects can impact the child's performance in school and long term may impact     employment and job options.      This study will determine whether changes in attention and social interactions are seen in     children treated for LRE using three of the most common medications used to treat pediatric     LRE. Children who are newly diagnosed with LRE by their doctors and are between 6-12 years of     age will be randomized to receive levetiracetam, lamotrigine, or oxcarbazepine.      There will be 12 study sites throughout the US. Children will undergo evaluation of their     thinking and ability to pay attention before and after starting drug treatment for LRE.     Regardless of the specific findings, results of this study will provide the information     needed to help parents and their clinicians choose treatment options that maximize cognitive     abilities in children with LRE, and provide the data needed for practice guidelines to be     established on the basis of cognitive side effect risks.   "
106511|NCT01891877|"     This study will look at the five different types of sickle cell and their relation to     self-reported ill health to determine whether or not one or two of the sickle cell haplotypes     are correlated with worse health outcomes. Participants can do complete the study in under     half an hour in the privacy of their own home.   "
106512|NCT01891864|"     The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in     patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75     response rate at Week 12.   "
106513|NCT01891851|"     The purpose of this study is to evaluate the drug-drug interaction between steady-state     concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the     multiple dosing regimen and to explore the short term safety and tolerability of multiple     doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.   "
106514|NCT01891838|"     The risk of bleeding is important during transsphenoidal surgery. This study aims to find if     the ventilation mode, controlled pressure and controlled volume, modifies the risk of     bleeding.   "
106515|NCT01891825|"     Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause     significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can     be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical     AF ablation.   "
106578|NCT01891006|"     The purpose of this study is to examine whether Negative Pressure Wound Therapy is an     effective wound treatment compared to conventional wound treatment in the period of time from     reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.   "
106516|NCT01891812|"     Patients who have sickle cell VOC are usually treated with opioids, such as morphine.     However, this current way of treating them has not improved the health, medical outcomes, or     rates of hospitalizations. In addition, since VOC can happen very frequently over a long     period of time, giving opioids over and over again can cause both short-term and long-term     problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better alternative     to repeatedly giving opioids over long periods of time. N2O has been shown to provide up to 3     hours of pain relief in inpatient patients with VOC whose pain did not improve with morphine     infusions, and is used extensively in France, where almost half of 85 pediatric emergency     departments use nitrous oxide to treat children with VOC whose pain did not get better with     standard treatment with morphine. However, pain relief which N2O provides in the acute     setting has not been well described. Therefore, the purpose of our study is to describe how     well N2O can relieve the pain in patients with SCD who present to the emergency department     and are experiencing a VOC.   "
107086|NCT01884402|"     Primary objective:      • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to     allow optimize treatment.   "
106517|NCT01891799|"     The purpose of this study is to understand how best to provide care and treatment services to     human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. The     study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission     (PMTCT)where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV)     therapy regardless of their disease stage. The goal is to prevent delays in women accessing     treatment for their own health and ensure that women and their children remain in care. This     study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the     current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health     facilities in the Manzini and Lubombo regions in Swaziland. The study has three components:     the main component is a PMTCT Options Evaluation where data from medical records will be     abstracted on all HIV positive pregnant women attending antenatal services at the 10 selected     study facilities; data will be abstracted on their HIV exposed infants as well. Other     components of the study include a PMTCT Options Acceptability Evaluation using     semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as a     cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.   "
106518|NCT01891786|"     The primary objective of the CORDIA study is to use an effective evidence-based     self-management intervention (SMI) for type 2 diabetes, with and without a novel test to give     a personalised genetic and lifestyle risk of coronary heart disease, to examine their     capacity to reduce the risk of coronary heart disease (CHD) and improve diabetes management     in primary care patients with type 2 diabetes. The effect of these interventions on clinical,     behavioural and psychological outcomes will be investigated.   "
106519|NCT01891773|"     Asthma is the most common chronic pediatric disease in the United States, and is the most     common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged     minority children receive disproportionately poor asthma care and incur a disproportionate     share of asthma-related morbidity. The District of Columbia is particularly severely     affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of     22%, more than double the national average.      One of the major challenges in treating asthma is poor adherence to daily controller     medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH     guidelines for asthma management. In an attempt to overcome poor compliance, investigators in     Rochester, New York have partnered with primary care providers in their community to arrange     for ICS administration at school by school nurses, and this approach yielded significant     improvements in several asthma outcomes.      The investigators propose to collaborate in a pilot research project with the overall goal of     improving asthma outcomes through reducing barriers to medication adherence. Specifically,     the investigators aim to improve adherence to controller medications (inhaled corticosteroids     - ICS) among DC children with asthma through the following activities:        1. A pilot prospective randomized clinical trial of home vs. school administration of ICS          among DC children in grades kindergarten-8 with persistent asthma.        2. Qualitative interviews with nurses from DC public and public charter school to identify          key barriers to administration of daily controller medications in the school setting   "
106520|NCT01891760|"     -  Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional          treatment of four-layer compression bandaging therapy alone, in subjects who completed          the ABH-Dermagraft-001-08 study.        -  Study Hypothesis: N/A (Long-term follow-up study)   "
106521|NCT01891747|"     This is a Phase I/II non-randomized prospective study of high-dose L-methylfolate in     combination with bevacizumab and temozolomide in patients with recurrent high-grade glioma.     The primary objective of this phase II trial is to determine whether the addition of     high-dose L-methylfolate to bevacizumab and temozolomide therapy improves progression-free     survival (PFS) compared to previously reported results.   "
106522|NCT01891734|"     This project will be the first to evaluate the Moving Forward app in VA. Identifying an     effective treatment for anxiety and depression in primary care is imperative within Veterans     Health Administration as they are both common, chronic, and debilitating conditions     associated with a number of personal and health-related costs. In close partnership with app     developers at Mental Health Services, a major contribution of this research is the actionable     feedback on the acceptability, feasibility and effectiveness of augmenting traditional     Problem Solving Therapy with the Moving Forward app for future app development. If     effectiveness can be established, Moving Forward has the potential for integration into the     larger continuum of care for depression and anxiety in Primary Care-Mental Health Integration     (e.g., care management, co-located collaborative care). Lastly, this pilot project will     provide preliminary data for future research on SmartPhone technology. Veteran feedback on     treatment components, ease of executing the study successfully and preliminary effect size     calculations, will inform the design of the larger project.   "
106579|NCT01890993|"     This study is conducted in Europe. The aim of this study is to demonstrate the clinical     effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy     in routine primary care in Europe.   "
107035|NCT01885065|"     The purpose of this study is to determine whether continuous use of edible, gel-based     artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms     of dry mouth and improve quality of patients' saliva.   "
106523|NCT01891721|"     Cognitive dysfunction is a major contributor to the poor community outcome of individuals     with schizophrenia. Developing more effective cognitive remediation interventions is     imperative to improve the daily lives of affected subjects and reduce the disability of this     illness. The goal of this clinical trial is to evaluate two types of cognitive training     approaches to determine which one is more beneficial for individuals with schizophrenia. This     study also uses electrophysiological techniques to gain a better understanding of the     mechanisms involved in cognitive remediation. Findings from this study will provide     information about how to design the most optimally efficient cognitive training intervention     to improve the cognitive and social functioning of patients with severe mental illness.   "
106524|NCT01891708|"     a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell     lung cancer   "
106582|NCT01890954|"     The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in     adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's     ability to significantly improve blood glucose levels when an insulin bolus is omitted for a     30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of     carbohydrates consumed for a meal. The primary objective of this study is to use a     closed-loop Control-to-Range (CTR) system to significantly reduce the post-prandial blood     glucose excursion in adolescents with type 1 diabetes who omit and/or under-bolus insulin for     either snacks or meals. Up to 20 subjects aged ≥13 and ≤18 years old will be tested.   "
106525|NCT01891695|"     The dose of radiation most commonly used to treat oropharyngeal cancer results in side     effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered     taste, swallowing problems including pain or inability to swallow requiring feeding tubes to     be placed in the stomach, hoarseness or breathing problems from swelling requiring     tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe,     nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear     drums in the middle ear, skin redness tenderness and blistering.      The purpose of this study is to determine if the investigators can reduce the dose of     radiation to the lymph nodes in the neck that may contain cancer cells that are not detected     by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in     order to reduce the side effects from treatment and still adequately kill any cancer cells     that may be contained in those lymph nodes.   "
106526|NCT01891682|"     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and     protein. Protein synthesis is increased mainly in the form of immune and signaling proteins,     while synthesis of muscle and structural proteins is decreased. The metabolism of sulfur     amino acids and specifically methionine and cysteine have not been investigated in critically     ill septic children, despite that sulfur amino acids have important roles on thiol,     antioxidant and epigenetic reactions, as well as precursor of glutathione (GSH). Methionine     metabolism in critically ill children will be influenced by its rate of utilization through     the transmethylation, remethylation and transsulfuration pathways, which are the major     pathways of methionine metabolism.      The investigators study aims to investigate the metabolism of methionine and cysteine in     parenterally fed critically ill septic children. The investigators aim to determine the rates     of transmethylation, remethylation, transsulfuration and GSH synthesis rates in critically     ill septic children, to determine in vivo, whole body sulfur amino acid metabolism when     sulfur amino acids are supplied by the parenteral route. The objective is to determine     whether current parenteral intakes support GSH synthesis and if methionine metabolism differs     when supplied by the parenteral versus the enteral route. Methionine parenteral requirements     will be also studied by using the indicator amino acid oxidation and balance technique.   "
106527|NCT01891669|"     To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients     with advanced solid tumors in order to determine the maximum tolerated dose and select the     recommended Phase 2 dose.   "
106528|NCT01891656|"     Substance abuse treatment in the criminal justice system can reduce drug use and related     criminal behavior. Although drug and alcohol treatment are common mandates in criminal     justice programs, only a minority of clients actually initiate treatment. This proposal will     compare two intervention formats that target motivation to initiate and engage in treatment     among a group of probationers who have drug or alcohol treatment conditions. Six hundred drug     and alcohol offenders in two probation sites (Baltimore, MD and Dallas, TX) will be     randomized to receive: 1) an in-person motivational interviewing session (MI), 2) a     motivational computer program (MC), or 3) supervision intake and monitoring as usual (SAU).     The MI condition will be structured along the lines of the Check-Up format which consists     of an assessment and personalized feedback delivered in an MI style; the content of the MC     condition will be drawn from previous literature on effective motivational computer programs.     Both interventions will be delivered at the start of the probation process, with follow-up     assessments at 2 and 6 months. Primary outcomes include engagement and participation in     substance abuse treatment; secondary outcomes include drug and alcohol use, probation     progress, criminal behavior, and HIV testing and care. This project will be the first to     develop and test two interventions for encouraging criminal justice clients to follow through     with treatment recommendations, with the goal of increasing treatment initiation, and     reducing subsequent drug use and criminal behavior. It also contributes to ongoing     partnerships with two large probation agencies—the Dallas County Supervision and Corrections     Department and the Maryland Division of Parole and Probation.   "
106529|NCT01891643|"     The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and     Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma     cells at the time of progression than those who receive Lenalidomide and Dexamethasone     without Elotuzumab   "
106530|NCT01891630|"     To determine if baseline asthma control influences susceptibility to pollutant-induced health     effects in African-American children with moderate-to-severe asthma.   "
106618|NCT01890486|"     To provide the IRB approved mechanism for the prospective collection, analysis and reporting     of data on patients who are undergoing either an autologous or allogeneic hematopoietic stem     cell transplant for a disease in which a research question is not being addressed and for     which peer reviewed, published data have demonstrated efficacy for this treatment approach.   "
106531|NCT01891617|"     Determine whether the mid-day suppression of hunger and amplified increase in the release of     glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following     morning exercise is due to increased fat content of the diet per se or a combination of high     fat diet after morning exercise. The action of gut peptides, particularly GLP-1, on gastric     emptying is likely to be important in mediating its effects on postprandial appetite and     glycemia (Nauck et al. 1997). Our hypothesis is that exercise amplifies gut peptide secretion     when diet is enriched with fat, and that this stimulus suppresses the hunger sensation.   "
106532|NCT01891604|"     Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm     infants' health, and may also play a role in reducing NEC and associated morbidity.   "
106533|NCT01891591|"     This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and     nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try     quantitate energy and protein balance after RYGP, and to identify how RYGP effects the intake     of various common dietary protein sources 16 female patients with BMI > 40 kg/m2 and on a     waiting list for bariatric surgery will be included. The following measurements will be     performed before, and 1, 3, 6, 12, and 36 months after RYGP        -  body weight        -  body composition (bio impedancemetry)        -  basal metabolic rate (open circuit indirect calorimetry)        -  24-hour urinary urea excretion        -  fasting blood chemistry        -  energy and macronutrient's intake (3-day dietary recall)   "
106534|NCT01891578|"     Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative     preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis     lymphoma   "
106583|NCT01890941|"     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to     placebo in patients with dry eye syndromes.   "
106535|NCT01891565|"     The amount of active therapy provided to patients on an inpatient stroke rehabilitation unit     has been reported as often insufficient. Observational studies have found that in the first     14 days post stroke, patients receive very little therapy and have very low activity levels.     More opportunity to practice may, however, improve short-term outcomes such as the level of     mobility, endurance, use of the affected arm and leg, and length of stay. The Stroke     Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT) trial will utilize sensors that     reveal the type, quantity, and aspects of quality of patient activities outside of the     confines of research laboratories. SIRRACT will deploy inexpensive Personal Activity Monitors     (PAMs), comprised of triaxial accelerometers worn on the thighs.      The objectives of the study are:      i. To assess the impact of feedback from Personal Activity Monitors (PAM)s on amount of     active practice, walking speed and distance in stroke patients undergoing rehabilitation.      ii. To assess the impact of feedback from PAMs on physical, psycho-emotional, cognitive and     ecosocial Health-Related Quality of Life of stroke patients undergoing rehabilitation.      iii. To assess the acceptability of thigh-strapped accelerometer use among stroke patients     undergoing rehabilitation.      iv. To assess the reliability and validity of thigh-strapped accelerometer use among stroke     patients undergoing rehabilitation.      Hypotheses In moderate to severely disabled subjects who are receiving in-patient     rehabilitation, daily feedback from PAMs about purposeful activity will increase the amount     of active practice by >30%, a higher proportion of subjects who reach the level of     independence for walking, and increase walking speed by 25%, leading to higher mean walking     speeds and distances at the time of discharge from inpatient rehabilitation. Daily feedback     from PAMs on increase in walking speed and distances will improve physical, psychological,     cognitive and ecosocial domains of Health-related quality of life.   "
106536|NCT01891552|"     -  The recently introduced chemoembolization has been considered to be a very attractive          new method in terms of response in the treatment of liver metastases from colon cancer          carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new          embolization materials.        -  An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in          patients with liver metastases from colon cancer, who had been pretreated with 2 or more          lines of chemotherapy.        -  Since a greater activity was attained by a combination of Cetuximab and Irinotecan          versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal          Products (EMEA) has granted authorization to the use of Cetuximab in association with          irinotecan in the treatment of irinotecan-refractory CRC-LM.        -  In this study we want to collect data on on time to progression and tolerability using          DEBIRI+Cetuximab in LM-CRC   "
106537|NCT01891539|"     Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh     in women and is the third most common cause of death from cancer worldwide. The overall     incidence of HCC remains high in developing countries and is steadily rising in most     industrialized countries.      TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy     option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were     developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence     within the tumor. The comparison of efficacy and safety of TACE with drug-eluting     microspheres in comparison with conventional TACE (cTACE) showed that response and time to     progression in the group was significantly higher than that of the cTACE group. TACE with     drug-eluting microspheres thus appears to be a feasible and promising approach to the     treatment of HCC.      This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using     drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.   "
106538|NCT01891526|"     To test whether patients with hepatic insufficiency can tolerate one oral dose of     9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.   "
106539|NCT01891513|"     The purpose of this study is to compare, when combined with chronic exercise, the effects of     perindopril, losartan, and hydrochlorothiazide.   "
106540|NCT01891500|"     The investigators in this study are concerned about the harmful effects of oxygen exposure in     newborn infants, particularly at high concentrations. Inhaled nitric oxide (iNO) is an FDA     approved drug for the treatment of hypoxic respiratory failure (HRF) in term and late-preterm     babies greater than 34 weeks gestation. Hypoxic respiratory failure occurs when a patient's     lungs cannot get enough oxygen into their bloodstream. This condition is traditionally     treated with high concentrations of oxygen and most often requires the patient be placed on a     ventilator (breathing machine). The administration of inhaled nitric oxygen directly into the     lungs often improves blood oxygen levels and allows caretakers to reduce the amount of oxygen     given to the baby. The purpose of this research study is to evaluate if giving the inhaled     nitric oxide earlier in the course of disease improves the effectiveness of the drug, reduces     the amount of cellular injury from oxygen exposure, and decreases the total amount of time a     patient requires supplemental oxygen. This study uses an FDA approved drug in a new manner.   "
106541|NCT01891487|"     This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus     placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week     study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects     eyebrow for duration of the study.   "
106542|NCT01891474|"     Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed     and improved glycemic control. However, previous U-healthcare service had some limitations,     which needs specific devices to check blood glucose and send it to central system. Voice     inception technique based U-healthcare service is expected to improve glycemic control     without specific devices.      To evaluate the clinical efficacy of this system, researchers plan to compare the improvement     of glycemic control, self-management, and quality of life between U-health care group     (intervention) and conventional treatment group (control).   "
106543|NCT01891461|"     The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease     intraoperative and immediate post-operative bleeding.   "
106584|NCT01890928|"     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and     protein. Often sick children have increased glucose concentrations in blood. However, the     origin of the high glucose has not been determined in these populations. There is a close     interrelationship between protein and energy metabolism. An increase in the energy supply     will not promote nitrogen retention unless the amino acid supply is adequate, and conversely,     an increased amino acid supply will be useless if energy is limiting, hence the importance of     adequate protein and energy intake. Our study aims to investigate the protein-energy     interactions in critically ill septic children and adolescents with the objective to     eventually provide the best nutritional support for these patients.   "
106647|NCT01890109|"     This is a randomized, stratified, double-blind, placebo-controlled, parallel-group study in     female subjects with HFs associated with menopause. This study will evaluate the efficacy of     AMG 334 as measured by reduction from baseline in the frequency and severity of daily HFs at     weeks 2, 4, 8, 12, and 16 after a single dose of AMG 334.   "
106544|NCT01891448|"     The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the     reporting of randomized trials. If trials are not well reported it is difficult for     clinicians to use best evidence to inform clinical practice and patients may not get the best     care. A number of different CONSORT extensions have been developed which specify additional     information needed for more complex trials. The aim of this project is to evaluate whether     using a simple web-based tool (WEBCONSORT) improves the reporting of clinical trials. The     tool combines different CONSORT extensions and allows authors to obtain a checklist and flow     diagram which is specific to their individual trial. In this study authors of participating     journals are requested, at the manuscript revision stage, to use a web-based tool to improve     the reporting of their randomized trial. Authors registering to use the tool are randomized     to intervention or control. In the intervention group authors are directed to the WebCONSORT     tool. In the control group, authors are directed to a different version of the WebCONSORT     tool which includes the flow diagram part of the tool but not the main checklist or elements     relating to CONSORT extensions. The aim is that this tool should lead to improvements in the     reporting of randomized trials, making it easier for clinicians to read and interpret     published findings.   "
106545|NCT01891435|"     A randomized clinical trial to check the antipyretic efficacy of oral and intravenous     paracetamol and intramuscular diclofenac sodium in patients presenting with fever to     emergency department.   "
106546|NCT01891422|"     The glycoproteinoses are among the most rare and least researched of the lysosomal diseases.     The diseases include aspartylglucosaminuria, fucosidosis, galactosialidosis,     alpha-mannosidosis, beta-mannosidosis, mucolipidosis II, mucolipidosis III, Schindler     disease, and sialidosis. Longitudinal studies of these conditions are needed in order to     better define how common the diseases are, identify clinical features which could contribute     to early diagnoses, detail progression of the diseases, assess the supportive therapies     currently used, and identify potential treatments. Laboratory tests will evaluate metabolic     and genetic defects found in participants' blood and urine samples.   "
106547|NCT01891409|"     A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male     circumcision device across all childhood age groups namely infants (under 1), 1-5 age group,     6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and     course of wound healing when using the Shang Ring technique across the four childhood age     groups.   "
106548|NCT01891396|"     The purpose of this study is to see if a single injection of Cingal into the knee provides     safe relief of pain caused by osteoarthritis.   "
106549|NCT01891383|"     The objective of this study is to measure the frequency and clinical types of mild cognitive     impairment (MCI) or dementia that occur among up to 150 military retirees with and without a     history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home,     Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare     the characteristics of dementia in those who have had a prior TBI to the characteristics in     those without a history of TBI. It is our hypothesis that the dementia or MCI among those     with prior TBI has distinct neuropsychological features that distinguishes it from those with     dementia or MCI without a history of TBI.   "
106550|NCT01891370|"     The purpose of this study is to get initial values (normal medians) for certain biochemical     serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood pressure     measurement and certain ultrasound measurement may be established.   "
106551|NCT01891357|"     The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response     evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast     cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with     lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12     weeks.   "
106552|NCT01891344|"     The purpose of this study is to determine which patients with ovarian, fallopian tube, and     primary peritoneal cancer will best respond to treatment with rucaparib.   "
106553|NCT01891331|"     CYP51 is an enzyme essential for fungal growth. Inhibition of CYP51 results in the     accumulation of compounds toxic to the fungus. CYP51 is the target of the class of drugs     referred to as 'azole antifungals'. The lack of selectivity by the azole antifungals is     responsible for many of the side effects associated with these drugs. VT-1161 has been design     to be safer and more active against the fungal species typically responsible for vaginal     yeast infections (i.e. vulvovaginal candidiasis)   "
124573|NCT01655160|"     The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms     of mirror therapy and its effects on physiological markers.   "
106555|NCT01891305|"     The purpose of this study is to determine if the novel oral agent VT-1161 is safe and     effective in treating patients with moderate - severe tinea pedis (also referred to as     athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal     growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the     fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole     antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this     results in many of the side effects associated with the azole antifungals. The safety profile     of the class similarly limits use in chronic treatment of non-life-threatening fungal     infections. A safer antifungal drug would improve treatment options for infections seen in     otherwise healthy individuals where significant side-effect risks are unacceptable.   "
106556|NCT01891292|"     The purpose of this study is to determine whether enalapril or antioxidant therapy     (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell     disease and and its progression to sickle nephropathy   "
106557|NCT01891279|"     In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or     omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed     the infant to wean off Total Parenteral Nutrition (TPN) earlier?   "
107284|NCT01881802|"     This trial aims to investigate the effects of opioid-inducing immune suppression on opioid     drug abused patients. The methods of the investigators research mainly includes the     expression of morphine-related miRNAs in peripheral blood mononuclear cells and cytokine in     plasma.   "
106558|NCT01891266|"     Background:      Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems     in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may     be the only option that offers the possibility of reestablishing the patient's life quality.      Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet     around the thigh. The method aims to reduce blood loss and give the surgeon better visibility     during the operation. The method is, however, not without side effects as patients often     experience severe pain and swollen leg in the time after surgery. Furthermore, has the method     shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced     physical function.      It is, however, possible to perform the operation without the use of the tourniquet.      Aim and hypothesis:      The aim of the present study is to assess the effects of tourniquet use in TKA on physical     function, early rehabilitation, pain and opioid consumption.      Hypotheses H1: TKA without tourniquet leads to better physical function and early     rehabilitation.      H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical     lower limb function post TKA is faster without use of tourniquet.      Methods:      80 patients (40 in each group) all eligible for TKA will be consecutively recruited and     randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated     before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.      The primary outcome will be the change from baseline to 3 months in self-administered     knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified     secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with     sports and leisure activities, and quality of life. In addition, muscle function, physical     performance, and the use of pain medication will be studied      Impact of the project:      The project design of this study will enable analyses for determining the impact of operating     without tourniquet and whether such an intervention can in fact improve physical function,     performance and quality of life within TKA patients. The results may impact notably on the     patient level and possible redefine current surgical strategies. The societal perspective of     the project is to remobilize patients faster, which may reduce hospital services and absence     from work.   "
106559|NCT01891253|"     Measuring hemodynamic parameters in ventilated patients is important yet still complicated to     perform. Inert gas rebreathing (IGR) showed promising results when being compared to other     invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of     our study is to evaluate the feasibility of IGR in ventilated patients.   "
106560|NCT01891240|"     The overall objective of the IMPROvED project is to develop a sensitive, specific,     high-throughput and economically viable early pregnancy screening test for preeclampsia.      This will involve a multicentre, phase IIa clinical predictive study to assess and refine     novel and innovative prototype tests based on emerging metabolomic and proteomic technologies     developed by SMEs (small to medium size enterprise) within the consortium. The study will i)     recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by     accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms     translate to the clinical environment; iv) assess potential synergy of a combined metabolomic     and proteomic approach and v) progress regulatory approval and development of the selected     test into the clinical arena.   "
106561|NCT01891227|"     Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy     with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine     alone until disease progression or unacceptable toxic effects. Safety assessments will be     conducted in 3-weekly intervals, efficacy assessments (CT or MRI) will be conducted every 9     weeks.      Aim of this study is to determine whether treatment with capecitabine in combination with     bendamustine is efficacious and safe.   "
106562|NCT01891214|"     The purpose of the study is to develop a validated French version of the IBDQ in a cohort of     patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative     Colitis.   "
106563|NCT01891201|"     The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has     any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary     objective is to assess the effects on exclusive breastfeeding at 3 months   "
106564|NCT01891188|"     Clinical studies are required to validate the hepatic NIRS monitor with other regional and     global hemodynamic parameters and to evaluate its clinical use for continuous non-invasive     hemodynamic monitoring. Using newer NIRS sensors the correlation between hepatic regional     oxygen saturation and hepatic venous oxygen saturation (SvHO2) needs to be determined. If     found to correlate then the NIRS can be used to evaluate early liver transplant failure     and/or hepatic artery thrombosis, used as an early marker for shock, and necrotizing     enterocolitis, and finally used in the outpatient setting to evaluate patients with chronic     liver pathologies. If our validation study finds that NIRS monitors are an appropriate marker     of hepatic venous saturation then it will lead to further clinical studies.   "
106565|NCT01891175|"     The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an     absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural     in the pregnant women, fact that worries for provoking undesirable effects so much in the     mother and as in the fetus /newborn baby.      The purpose of this study is to determine the effectiveness of intermittent pneumatic     compression system in the lower extremities in order to reduce the vasopressors drugs     requirements to maintain hemodynamic stability in pregnant women undergoing elective     caesarean sections with an spinal anaesthesia.   "
125395|NCT01643824|"     This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy     (PBT) for HCC patients in hepatitis B endemic area.   "
106566|NCT01891162|"     Age, parity, obesity and a number of comorbidities are the major clinical and lifestyle risk     factors for female urinary incontinence and pelvic organ prolapse at the population level.     The socioeconomic risks for incontinence have however, conflicting evidence with assorted     measures of socioeconomic status. Brazil is a country with enormous social contrasts, and     deep inequality. We have a mixed origin of cultures and different economic and regional     conditions. We believe that the perception and the impact that has Pelvic floor dysfunction     in the quality of life of the woman must vary widely according to socioeconomic status     (including household income, highest educational level, family income). There is to date no     studies have correlated a criterion for classifying economic official in Brazil with the     impact of quality of life (based in KHQ or PQOL) of women with urinary incontinence and     pelvic organ prolapse.   "
106567|NCT01891149|"     This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic     and hormonal characteristics of women and without obstetric fistula.      Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is     at least 10 mm shorter than the mean cervical length measurement of similar women without     obstetric fistula.      Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with     obstetric fistula will allow us to assess the cause of amenorrhea in these women.   "
106568|NCT01891136|"     This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize     peanut allergic patients to peanuts in order prevent peanut allergic reactions.   "
111945|NCT01820637|"     To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable     performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal     Artery (PPA) lesions.   "
106570|NCT01891110|"     Background:      The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution     during verticalisation in persons with spinal cord injury (SCI) is a common condition.      Aims:      To investigate the impact of three different types of electric stimulation (ES) (ES of the     abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and     lower limb muscles versus control) on blood pressure stabilization and     verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced     contractions of the muscles cause a stabilisation respectively an increase of the blood     pressure during the tilt-table test.      Subjects:      20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a     lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C     and a diagnosis of OH (by tilt table test) were eligible for the study.      Methods:      Each patient underwent randomly three different types of ES sessions while being positioned     on a tilt-table. The following sessions were planned:      A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D)     Control session (=diagnostic session)      Study type: Intervention Design: Prospective interventional study   "
106571|NCT01891097|"     This is a randomized controlled trial to evaluate the clinical efficacy of combined     electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult     population in Hong Kong.   "
106572|NCT01891084|"     The purpose of this study is to investigate the potential benefits and risks of antipyretics     use in naturally occurring influenza virus infections in humans.   "
106573|NCT01891071|"     Multiple sclerosis is a neurological disease that can affect lung function and cough     efficacy. This pilot study will examine whether the lung volume recruitment technique can     slow down the decline in lung function and cough.   "
106574|NCT01891058|"     Atrial fibrillation (AF) and atrial flutter (AFL) are cardiac rhythm problems where there is     an irregular, rapid heart rate. Investigators plan to study Emergency Department (ED)     patients with recent-onset episodes of AF or AFL (RAFF) where rapid heart rate requires     urgent treatment to restore normal heart rhythm. RAFF is the most common rhythm disorder     managed in the ED. Investigators recently showed that doctors use a wide variety of treatment     approaches in Canadian EDs for RAFF. Also, the Canadian Cardiovascular Society Guidelines     indicate that there have not been enough studies to know if the best treatment is to use an     electrical shock (Shock Only) or drugs followed by shock (Drug-Shock). Investigators believe     that Drug-Shock approach will be more effective and will help avoid an electric shock for     many patients. Investigators also do not know if electrical shocks should be given with the     electrode pads on the front (antero-lateral) or front and back (antero-posterior).      Investigators intend to conduct 2 randomized protocols within one study (partial factorial     design) in order to answer these two questions. 1. Will initial drug treatment followed by     electrical shock if necessary (Drug-Shock) lead to more patients being converted to normal     heart rhythm than a strategy of only electrical shock (Shock Only)? 2. Will the     antero-posterior pad position be more effective than the antero-lateral position?     Investigators plan to enroll 468 RAFF patients at 8 large Canadian EDs. Patients will be     randomized to 1 of 2 arms for each of the two protocols. Investigators primary outcome will     be conversion to normal heart rhythm. Other outcomes will include heart rhythm at discharge,     need for hospital admission, length of stay in ED, adverse events, patient satisfaction, and     14-day follow-up status.      Investigator results will add important information about the best and safest ways to treat     RAFF patients in Canadian EDs. Ultimately Investigators expect to see fewer patients admitted     to hospital and more patients rapidly and safely returned to their normal activities.   "
106575|NCT01891045|"     Dropout represents one of the largest problems in substance abuse treatment. International     and Nordic research show that only 20 - 40 % of substance abusers complete treatment as     intended. At the same time, one of the most consistent factors of favourable post-treatment     outcome is treatment completion. In spite of the serious and continuous challenge dropout     represents the phenomena is not well understood and there is a need to explore more of the     factors that influence dropout and how it can be counteracted. As also stated: …effective     methods for reducing the problem of dropouts from treatment is one more area in need of     further research (NOU 2003:4, s 77).      For the general field of mental health one of the most important innovations involves     providing therapists with patient feedback about their progress. The most well-established     and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has     been shown to improve treatment outcomes, including reduced treatment dropout and length of     treatment, but the system is yet to be utilized with a substance abusing patient group. The     aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing     patients.   "
106576|NCT01891032|"     Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be     related with the degree of acute kidney injury. We are trying to analyze whether it is     related with the grade of acute kiney injury after partial nephrectomy and there is any     difference between the kinds of surgery.   "
106577|NCT01891019|"     The objective of this study is to obtain information on the effectiveness of thalidomide in     psoriasis.   "
106619|NCT01890473|"     The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of     Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or     the approved prefilled syringe.   "
106580|NCT01890980|"     The goal of this clinical research study is to learn if the Wilms Tumor-1 (WT1) vaccine, when     given in combination with montanide and GM-CSF, can help to prevent or delay mesothelioma     from coming back after surgery and treatment. The safety of this vaccine will also be tested.      Montanide and GM-CSF are designed to cause white blood cells to grow, which may help to     increase the immune response.      WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.     Mesothelioma tumors usually have high levels of WT1. The WT1 vaccine is designed to cause the     increased immune response created by other drug combinations (like montanide and GM-CSF) to     be directed at mesothelioma.   "
106581|NCT01890967|"     This study is designed to define the amount and duration of cholesterol lowering and to     assess the safety and tolerability of different dose regimens of LY3015014 in participants     with high cholesterol. The study will also investigate how the body processes the drug and     how the drug affects the body. Participants will remain on a stable diet and will continue     taking cholesterol-lowering medications (statins with or without ezetimibe). After signing     the informed consent document, the participant will complete a screening/run-in period that     will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After     the treatment period, the participants will complete a follow-up period lasting approximately     8 weeks for a total study duration ranging from approximately 25 to 32 weeks.   "
106585|NCT01890915|"     The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However,     the consequences of impaired regulation of normal body temperature on cognitive performance     of persons with tetraplegia is not known. This study will provide the preliminary findings     necessary for future work to design and explore physical and medical interventions to improve     temperature regulation in those with tetraplegia with the goal of improved clinical care,     health, and quality of life.      The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10     controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours.     Physiological as well as psychological processes will be monitored in all subjects during the     study for safety and to determine differences in responses to exposure to hot ambient     temperatures   "
106586|NCT01890902|"     The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen     10% Cream) compared to placebo for acute pain associated with OA flare of the knee.   "
106587|NCT01890889|"     The purpose of this study is to evaluate the effectiveness of a food-source nutrient     containing bitter orange by comparing changes 45 blood chemistries and self-reported quality     of life.   "
106588|NCT01890876|"     Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which     may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500     - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose     metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance     considering the increasing number of persons suffering from impaired glucose tolerance or     diabetes and the unique opportunities provided by the mountainous regions of the Alps to     perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude between     1500 - 3500 m. Metabolic responses to exercise may be largely mediated by interleukin 6     (IL-6), which is predominantly derived from the contracting limbs and may support the     maintenance of metabolic homeostasis during exercise. In addition, IL-6 is elevated with     acute and chronic altitude exposure at least partly mediated via adrenergic stimulation.     Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations and     differences in serum IL-6 concentrations might help to explain distinctions between responses     of glucose metabolism to CE and EE at low and moderate to high altitude.      32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or     uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions     at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic condition will be     a break of approximately 12 month. Measurements of glucose metabolism, IL-6 plasma     concentration will be performed pre, mid (day 5) and post intervention. Moreover     anthropometric, strength and exercise capacity characteristics will be performed pre and post     intervention.      We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in     pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that     effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE     in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than     CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in     normoxia.   "
106589|NCT01890863|"     This study will compare the pharmacokinetic (PK) of Fluticasone Propionate/Salmeterol     combination (FSC) 100/50 micrograms (mcg) delivered via the capsule-based inhaler (Rdpi)     relative to FSC 100/50 mcg delivered via the multi-dose dry powder inhaler (Ddpi) to     establish whether the Rdpi inhaler has exposure (in terms of fluticasone propionate area     under time concentration curve [AUC] and Salmeterol maximum concentration [Cmax]) no greater     than 1.2500 compared to the Ddpi, sufficient to allow progression to Phase 3. This study will     enroll 36 healthy adult male and female subjects and each subject will be allocated to one of     two sequences and will participate in four treatment periods, receiving each of the     treatments twice.   "
106590|NCT01890850|"     This study aims to estimate the risk factors associated with pertussis/whopping cough     infection among infants less than one year of age in a United States (U.S.) commercially     insured population. The study will utilize a large research data base associated with a     geographically diverse U.S. health plan not limited by one geographic area or disease     outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and     utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by     the number of DTaP vaccinations received prior to infection will also be reported.   "
106591|NCT01890837|"     The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times     per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal nerves),     and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation     threshold for pain) in response to rectal balloon distension by barostat in patients with     IBS.   "
106592|NCT01890824|"     Following chemotherapy, breast cancer patients primarily gain fat mass and lose muscle mass.     Both depletion of muscle and an increase of fat mass in breast cancer patients are related to     short survival, and decreased skeletal muscle mass and function may result in fatigue and     inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity     and increased mortality. The purpose of this study is to provide detailed insight in     chemotherapy related changes in lipid metabolism and gut digestion and absorption of fat in     breast cancer patients compared to matched healthy controls. This will provide required     information that is necessary to implement new strategies to develop optimal nutritional     regimen in breast cancer patients. The hypothesis is that chemotherapy in breast cancer is     related to altered gut function and absorption and to increases in fat synthesis that lead to     fat accumulation. In addition, we will examine the effect of cancer, chemotherapy, and gender     by comparing fat digestion/absorption and fat metabolism of the breast cancer before and     after chemotherapy, to aged matched healthy female and male controls.   "
106593|NCT01890811|"     Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively     influencing their quality of life, treatment response and survival. Loss of muscle protein is     generally a central component of weight loss in CKD patients but patients also have     reductions in fat mass and bone density, independent of the severity of the disease state.     Attempts to reverse weight and muscle loss in CKD and improve nutritional status by     nutritional supplementation have been unsuccessful and there are currently no approved     therapies.      Purpose of this study is to provide detailed insight in disease related gut function by     obtaining information on gut permeability, digestion and absorption of glucose, fat and     protein in CKD patients compared to matched healthy controls. Additionally, to examine     whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy     controls. This will provide required information that will lead to implement new strategies     to develop optimal nutritional regimen in order to enhance nutritional status, quality of     life and survival in relation to kidney disease.   "
106804|NCT01888068|"     A new investigational device (BIA/Vitality Analyzer™) is being compared to a United States     Food and Drug Approved 'predicate' reference device (EFG®) to demonstrate that they provide     equivalent measurements of body fat. Both devices are over-the-counter bioimpedance body     composition analyzers (estimate of body fat). These devices are classified as 'Not     Significant Risk' devices; they do not expose you to any significant risks.   "
106596|NCT01890772|"     This study is for people who have been diagnosed with chronic hepatitis C, specifically those     who have a certain type of the virus, genotype 1, and who have not yet received treatment for     hepatitis C. This pilot study is designed to test whether the addition of vitamin D, to the     three drugs (Incivek (telaprevir), Pegasys (peginterferon alfa-2a), and ribavirin) that are     approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C, can help     eliminate the HCV from the body. Currently, doctors are unsure if the addition of vitamin D     to prescribed hepatitis C therapy will have any effects on how the body clears the virus.      Once enrolled, participants will be randomly assigned (like flipping a coin) to receive     telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (treatment group) or telaprevir +     peginterferon alfa-2a + ribavirin (control group). A total of 80 participants, of all     races/ethnicities, will be included in this study, at 5 to 10 VA hospital study sites (10 -     20 participants/site).      Participants assigned to the treatment group will begin a lead-in phase where they will     receive 5,000 IU of vitamin D3 per day. Every two weeks during the lead-in phase,     participants will be tested to determine the Vitamin D level in their blood, as well as other     tests, including HCV RNA (to determine the amount of virus present) and calcium levels. Once     an adequate level of Vitamin D is detected in participants' blood, participants will begin     treatment with telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (15,000 IU/week)     for 12 weeks.      Participants randomized to the control group will immediately begin treatment with telaprevir     + peginterferon alfa-2a + ribavirin for 12 weeks. At the end of Week 12 the participants'     involvement in the study will be complete.      Adverse events and effects of vitamin D3 will be obtained by assessing participants' medical     history, physical examination, and blood tests at clinic visits. HCV RNA will be assessed at     Screening, Day 1, Week 2, 4, 8 and 12.   "
106597|NCT01890759|"     The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine     given as a two-dose series in infants and toddlers.      Primary Objectives:        -  To assess the seroprotection rate (percentage of subjects with a serum bactericidal          assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses          of Menactra® administered 3 to 6 months apart.      Secondary Objectives:        -  To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135)          28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.        -  To assess the safety profile of Menactra® after each and any vaccination.   "
106598|NCT01890746|"     The purpose of this randomized, blinded, placebo-controlled study is to provide clinical     safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute     Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus     cytarabine. These safety data are considered necessary to further development of Eltrombopag     in both adult and paediatric patients suffering from malignant diseases with secondary     thrombocytopenia. A minimum of 120 evaluable subjects with newly diagnosed with AML will be     stratified by antecedent malignant hematologic disorder and age.   "
106599|NCT01890733|"     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™     device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff     Tear .      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick     DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily     living(ADL) and improvement of range of motion (ROM).   "
106600|NCT01890720|"     The purpose of this study is to examine whether obese women (BMI >= 30) who give birth by     caesarean section have a reduced incidence of wound infection and dehiscence when incisional     Negative Pressure Wound Therapy is applied prophylactically following caesarean section.   "
106601|NCT01890707|"     The use of deep sedation may improve the quality of recovery of patients undergoing minor     gynecologic procedures. These patients may also have shorter hospital stays and potentially     lower healthcare costs. Additionally, the use of deep sedation for second trimester pregnancy     termination may be associated with less bleeding, a smaller decrease in perioperative     hemoglobin and better quality of recovery.   "
106602|NCT01890694|"     Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals     with cirrhosis may develop low blood sodium as a complication of their liver disease. In     these patients, the presence of low blood sodium may exacerbate other complications such as     encephalopathy, resulting in confusion, drowsiness, or coma. It may also affect the ability     of the body to fight infection. In certain cases, cirrhotic patients may be hospitalized for     the treatment of their low blood sodium.      The drug tolvaptan is currently FDA approved for the treatment of hyponatremia in patients     with cirrhosis. Although it has been shown to increase the sodium level, the clinical trials     that led to its approval did not otherwise assess clinical benefit of the drug.      This study is designed to determine whether patients with cirrhosis derive a clinical benefit     when they receive tolvaptan for the treatment of hyponatremia within 2 days of admission.     Specifically, whether it is associated with shortened length of stay and improvement in other     complications of cirrhosis.   "
106603|NCT01890681|"     This study will evaluate the efficacy of a six-month-long intervention in improving the     nutrition and physical activity environments of child care centers serving racially and     ethnically diverse children from birth to two years of age and the family home. The focus of     the intervention will be on center policies, provider and parent practices, and children's     home environments that influence dietary intake and physical activity. Outcomes for this     study include child dietary intake, physical activity, and two adiposity measures:     weight-for-length and skinfold thicknesses. Child care centers and children's home     environments will also be measured to evaluate how well they support healthy behaviors.   "
106604|NCT01890668|"     Breastfeeding is one of the prime factors of long-term health protection in newborns, for     nutritional, immunological and developmental reasons. In France there is a wide     inter-regional variability of breastfeeding rates at discharge. This variability associates     different factors involving both, mothers, birth conditions, newborns and mother-child     couple. Some approaches, including osteopathy, aim to support early breastfeeding     difficulties. As many others non-conventional medicines, there is a huge and growing interest     for this alternative therapy and a spontaneous recourse in the first months of life.     Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to     evaluate for the first time in France, in a randomized, double-blinded design, the efficacy     of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour     healthy newborns.      128 couples mother-child will be randomized in two groups: with or without osteopathic     intervention on the newborn.   "
106605|NCT01890655|"     To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing     remitting multiple sclerosis (RRMS).   "
106606|NCT01890642|"     This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in     children ages 6 and younger. The investigators will use video observation of patients to     asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain     Ease spray 3) Pain Ease spray plus the J tip noise.   "
106610|NCT01890590|"     CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to     a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the     target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the     efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain     metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of     this protocol is to evaluate the role of Radiosurgery for the treatment of clinically     localized primary renal cell carcinoma.   "
106611|NCT01890577|"     An observational study to describe the treatment of anaemia in patients with chronic kidney     disease, who are receiving dialysis treatment at selected study centres in South Africa.   "
106612|NCT01890564|"     During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical     visualization. Although effective in facilitating the procedure, there are respiratory     consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure     (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and     increase closing capacity resulting in increased resistance, decreased compliance, and     increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will     evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to     determine which is better able to support oxygenation and ventilation while limiting the peak     inflating pressure (PIP).   "
106613|NCT01890551|"     Purpose: The impact of kinematic-MRI (KINE-MRI) in the patellofemoral instability and     anterior knee pain of the adolescents is rarely reported.Interest was to evaluate the     patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected     knees in a case-control study.Methods: KINE-MRI was performed in 29 adolescents (affected     knee group, AKG, n=29 and n=26 unaffected knee group, UAKG, n=26) aged 11-16 years with     unilateral patellofemoral instability. For the control group invvestigators enrolled ten     healthy age- and sex-matched volunteers (healthy knee group, HKG, n=19 ).The study     parameters, Bisect Offset (BSO), Lateral Patellar Displacement (LPD), Patellar Tilt Angle     (PTA), Sulcus Angle and Insall-Salvati ratio at 0, 10, 20 and 30 degrees of     flexion-extension, were measured for the AKG patients (n=29), and UAKG patients (n=26) and     the HKG subjects (n=19). Results: In a comparison between the AKG patients and the HKG     subjects there was a significant difference in the BSO-ratio, LPD-test and PTA-test. In these     parameters the difference between the AKG patients and the HKG subjects progressively     increased towards the full extension of the knee. In the AKG and UAKG patients BSO-ratio at 0     degree ranged between 0.5 and 1.2 in both groups, whereas the BSO-ratio in the HKG subjects     ranged between 0.33 and 0.75 (P < .001). At the zero degree the LPD-test ranged between 0 and     10 mm in the AKG patients and between 0 and 35 mm in the UAKG patients, whereas the lateral     displacement-test ranged between 0 and 5 mm in the HKG subjects (P = .003). Patellar tilt     angle-test ranged between -30 and 20 degrees in the AKG patients and between -30 and 24     degrees in the UAKG patients and in the HKG subjects the PTA-test ranged between 10 and 24     degrees (P < .001).Conclusion: The KINE-MRI could be a feasible method for the evaluation of     patellar tracking in adolescents.   "
106614|NCT01890538|"     This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate     and piracetam) in the symptomatic management of peripheral vertigo.      The patients will be randomized in two groups according to symptomatic treatment modalities:     Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30     minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to     a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate     the intensity of symptoms in the following times:        -  Numeric rating scale (1 to 10): Admission        -  Numeric rating scale (1 to 10): After the study drug (No ambulation)*        -  Numeric rating scale (1 to 10): After the study drug (Ambulation)*             -  Ambulation refers to head movements or walking in the room, if applicable.   "
106615|NCT01890525|"     The purpose of this study is to compare different methods of collecting the amount of     radiation exposure patients receive in a clinical study. As part of the PROMISE study, the     Duke Clinical Research Institute Outcomes and Follow-up Group will be contacting patients     every six months to ask if they had any heart procedures or testing. This information will be     used to estimate the amount of radiation that they may have received from heart testing being     studied in this study, PROMISE-SAFER. Patients will be asked to collect information about     each heart testing they receive during the time that they are enrolled in the PROMISE study.     At the conclusion of the study, we will be able to determine which method was most accurate     in collecting the amount of radiation exposure for this clinical study. Through this study we     hope to develop an improved methodology to estimate cumulative radiation exposure from     cardiac imaging. Comprehensive measurement of cumulative radiation exposure to patients may     be critically important to minimize potential harm in future studies and in clinical     practice.   "
106616|NCT01890512|"     The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed     at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI     or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial     pacing lead(s)) when used in the Magnetic Resonance Imaging environment under the labeled     Conditions of Use.   "
106617|NCT01890499|"     Prospective randomized controlled trial investigating commencement of low residue diet versus     clear feeds on postoperative day one following elective colorectal surgery, with regards to     patient tolerability, incidence of nausea and/or vomiting, and postoperative length of     hospitalization stay.   "
107207|NCT01882816|"     The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam     radiation therapy, has on the patient and their thyroid cancer where surgery is not an option     or where despite surgery, the disease is still present.   "
106620|NCT01890460|"     The purpose of the study is to compare ultrasound measurements of the liver obtained prior to     surgery on the skin to measurements obtained during surgery directly on the diseased liver.     The objective is to determine if ultrasounds of the liver on the skin can provide accurate     measurements of disease of the liver to provide an alternative option to liver biopsies.   "
106621|NCT01890447|"     This study aims to establish an effective method to inform parents or close relatives of     newborns about the risk of pertussis transmission to newborns and the advantages offered by     the cocooning strategy (vaccinating those who are in close contact with the newborn) by     assessing the factors that affect the parents' decision-making to accept pertussis     immunisation.   "
106805|NCT01888055|"     The aim of this study is to investigate whether the anodal transcranial direct current     stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults leads to an     increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).   "
106622|NCT01890434|"     Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs     and/or symptoms, will be invited to participate in the study. The duration for a subject in     the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be     required.      The primary objective of this study is to demonstrate that sensitivity and specificity of     gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum     performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over     unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD.     The CMR images acquired with a uniform imaging acquisition software will be evaluated either     against the results from routine clinical Coronary Angiography (CA) or Computed Tomography     Angiography (CTA), which are the standard of reference.      CMRI and CA/CTA images will be collected for an independent image review (blinded read).   "
106624|NCT01890408|"     Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver     resection. But, opioids tend to be ineffective for pain that is associated with movement and     have significant short-term side effects including nausea, vomiting, sedation, pruritus,     constipation, urinary, retention, and respiratory depression, which are factors that often     hinder a patient's recovery. Prospective randomized trials has found continuous wound     catheter analgesia as an accepted alternative to IV morphine PCA.      The researchers will investigate whether ropivacaine, administered through a wound catheter     placed by the surgeon, will reduce morbidity and provide a better recovery.   "
106625|NCT01890395|"     To identify patients who may be predisposed for developing MOF (multiple organ failure)by the     sampling of blood.   "
106626|NCT01890382|"     The combination of protein and resistance exercise seems to be one of the most effective     tools to counteract sarcopenia. Randomized controlled trials supporting this possibility are     still scarce. These series of clinical trials aim to investigate the therapeutic role of     protein ingestion combined with resistance training in frail elderly participants. These     studies will mainly address the following research questions: Is the protein source (i.e.,     whey versus soy) a factor in inducing a differential anabolic response? Does dietary protein     consumption dictate a whey/training-induced anabolic response? Does leucine supplementation     promote anabolic response? Does co-supplementation of creatine and whey protein foster an     anabolic response?   "
106627|NCT01890369|"     The investigators plan to explore the ability of amino acids, the building blocks of proteins     in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The     investigators will investigate how rapidly after one meal the human body is ready to make use     of a second meal and look at the molecular mechanisms underlying this. The investigators will     look at these phenomena in older men as this group is known to be subject to a gradual loss     of muscle mass and strength.   "
106628|NCT01890356|"     Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for     depression and have shown promising efficacy. However, there is no published data to date on     their effectiveness as a maintenance treatment. This study will investigate ways of using TES     as a maintenance treatment to prevent relapse in depression.   "
106629|NCT01890343|"     Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as     measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal     volunteers and subjects with Alzheimer's disease (AD).   "
106630|NCT01890330|"     MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is     a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low     HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade     chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function.      This study will investigate the effect of a 12 week intervention with canola oil versus the     typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS     parameters. CVD risk will be assessed based on the profile of lipids and other factors in the     blood as well using specialized equipment for non-invasive monitoring of blood vessel     function.   "
106631|NCT01890317|"     Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate     whether induction of mild hypothermia in addition to primary percutaneous coronary     intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic     shock improves cardiac power index after 24 h.   "
106632|NCT01890304|"     To identify the changes in the brain following repeated sports-related concussion in men's     football, women's soccer, and women's lacrosse college athletes by reviewing the findings of     MRI studies that look at the structure of the brain and the appearance of the white matter at     baseline, during the acute phase of a concussive injury, and upon completion of collegiate     athletic play and correlate these findings with standard clinical measures.   "
106633|NCT01890291|"     To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment     groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular     carcinoma in Korea   "
106634|NCT01890278|"     In this study the patient will receive either whole brain radiation therapy given by     intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT     therapy radiation dose to the parts of the brain that do not contain tumors is reduced. This     study will look to see if this approach results in less hair loss or fewer memory Problems,     as compared to the standard technique. The study will also look at the effectiveness of both     techniques in controlling the growth of the tumor.   "
106636|NCT01890252|"     The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal     surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,     such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal     dystrophies as well as post-surgical conditions resulting from cataract extraction and     corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and     disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care     professional.      In addition Hyper-CL™ contact lenses can also provide optical correction during healing if     required.      Prospective open-label, randomized, crossover clinical study To evaluate the safety and     efficacy of the Hyper-CL™ lens in subjects suffering from corneal edema.      This study is designed to evaluate the efficacy of the Hyper-CL™ lens contact lens on corneal     edema thickness as compared with salt solution treatment only in subjects suffering from     corneal edema.      Treatment with the Hyper-CL™ lens may result with greater reduction in edema thickness as     compared with treatment with salt solution only in subjects suffering from corneal edema.      Men and women suffering from a decrease in vision due to corneal edema that meet the     inclusion/exclusion criteria and provide written Informed Consent will be enrolled in the     study.      A total of 25 subjects will be enrolled. Each subject will be treated with:        -  Treatment A: Hyper-CL™ lens only (7 days)        -  Treatment B: Hyper-CL™ lens + salt solution (7 days)        -  Treatment C: salt solution only (7 days) One week (7 days) of washout without any          treatment will be between treatments. Subject will be equally allocated (with a          1:1:1:1:1:1 ratio) to one of the following 6 crossover regimen based on a randomization          scheme with blocks stratified by center: C-A-B; B-C-A; A-B-C; C-B-A; B-A-C; A-C-B.      Up to 2 centers will participate in this study. Each subject will be followed from baseline     to 42 days. All Subjects will come for a clinic visit at 7, 14, 21, 28, 35 and 42 days post     first treatment.      Completion of active enrolment is anticipated to last approximately 6 months. The primary end     point will be achieved when the final study subject has completed 42 day follow-up.   "
106637|NCT01890239|"     BACKGROUND Demographic trends coupled with a rise in chronic diseases mean that the     population of patients requiring palliative and end-of-life care is ageing. Due to the ageing     population palliative care for older people has been identified as one of the worldwide     public health priorities. A majority of elderly patients die in hospital. Studies from the     United Kingdom and other countries have shown that many older persons dying in hospital     experience suboptimal care. The Care Programme for the Last Days of Life has been developed     to improve the quality of end-of-life care in acute geriatric hospital wards. The programme     is based on existing end-of-life care programmes but modeled to the acute geriatric care     setting. There is a lack of evidence of the effectiveness of end-of-life care programmes and     the effects that may be achieved in patients dying in an acute geriatric hospital setting are     unknown. The aim of this study is to evaluate the effectiveness of the Care Programme for the     Last Days of Life in improving the quality of care and quality of life during the last 48     hours of life of patients dying in acute geriatric hospital wards in Flanders as compared to     usual care.      METHODS In order to contribute substantially to the increase of evidence for the effect of     the Care Programme for the Last Days of Life in patients dying in acute geriatric hospital     wards, a cluster randomized controlled trial will be conducted. Ten hospitals with one or     more acute geriatric wards will conduct a one-year baseline assessment during which care will     be provided as usual. For each patient dying in the ward, a questionnaire will be filled in     by a nurse, a physician and a family carer. At the end of the baseline assessment hospitals     will be randomized to receive intervention (implementation of the Care Programme) or no     intervention. Subsequently, the Care Programme will be implemented in the intervention     hospitals over a six-month period. A one-year post-intervention assessment will be performed     immediately after the baseline assessment in the control hospitals and after the     implementation period in the intervention hospitals. Primary outcomes are symptom frequency     and symptom burden of patients in the last 48 hours of life.      DISCUSSION This will be the first cluster randomized controlled trial to evaluate the effect     of the Care Programme for the Last Days of Life for the acute geriatric hospital setting. The     results will enable us to evaluate whether implementation of the Care Programme has positive     effects on end-of-life care during the last days of life in this patient population and which     components of the Care Programme contribute to improving the quality of end-of-life care.   "
106638|NCT01890226|"     Poor quality of medical care is a major contributor to excess medical morbidity and premature     mortality in persons with serious mental illnesses (SMI). To address this problem, community     mental health providers are increasingly partnering with safety net medical providers to     develop behavioral health homes, integrated clinics in which persons with SMI receive     coordinated medical and mental health care. However, behavioral health homes have faced     logistical and privacy challenges in integrating electronic medical records across     organizations.      This application proposes to develop and test a mobile Personal Health Record (mPHR) to     overcome this problem while more fully engaging patients in their health care. The study will     develop, test, and disseminate the mPHR. The investigators will develop the app building on     experience and preliminary data from a PC-based PHR project, and link it to the medical and     mental health EHR in a behavioral health home. Next, the investigators will conduct a     randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.   "
106639|NCT01890213|"     This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus     replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers     such as colon cancer in patients that have stage III colon cancer. We will also evaluate the     patient immune response to the vaccine.   "
106640|NCT01890200|"     This is a randomized, double blind, multi-center, placebo controlled, three parallel arms,     Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high     dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV     infection.      This will be demonstrated by a higher sustained virologic response rate, defined as the     absence of detectable HCV RNA 24 weeks after the termination of combination treatment,     compared with the placebo add-on.   "
106641|NCT01890187|"     The objective of this study is to determine the repeatability and reproducibility of the     Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).   "
106642|NCT01890174|"     The objective of this study is to determine the repeatability and reproducibility of the     Cirrus HD-OCT measurements of drusen area and volume.   "
106643|NCT01890161|"     This is the first study in human patients with asthma that the sponsor is conducting in order     to evaluate if there are signals that the investigational medication, AXP1275, may be a safe     and effective treatment for asthma. The results of this study may help the sponsor to design     additional studies.   "
106644|NCT01890148|"     Distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4     wk treatment with AZD 5069   "
106645|NCT01890135|"     Peripheral artery disease (PAD) is a major complication of atherosclerosis when blockages in     the arteries to leg reduce blood flow and one of the resulting problems is termed     intermittent claudication (IC). IC is leg pain with walking that is relieved with rest and IC     is the most frequent clinical manifestation of PAD and it effects millions of Americans. The     number of patients with, and the health care costs of, PAD will increase as the prevalence of     PAD is associated with advancing age, diabetes, and smoking. Zibotentan (ZD4054) is an     endothelin receptor A (ETA) blocker that undergone extensive human testing and has been shown     to be safe in several patient population. There is ample evidence to suggest that an ETA     blocker could improve blood flow to the legs in patients with PAD. In a study that will be     funded by the National Institute of Health, the investigators will test the ability of this     medication to allow better blood flow to the legs of patients with PAD. In patients with IC,     the investigators will test the ability of ZD4054 to improve leg blood flow using a     non-invasive imaging technique. In parallel the study will test for the ability of patients     with leg pain to walk further and feel better.   "
106646|NCT01890122|"     The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin     fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2     Diabetes Mellitus (T2DM).   "
106648|NCT01890096|"     A single high dose rate brachytherapy (HDR) treatment combined with a short course of     external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men     with intermediate risk prostate cancer. High cancer control rates have also been reported     with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose     to use with a move towards one or two fractions by several investigators. These schedules are     reported to be well tolerated in the short term, but with little long term data. The     objective of this study is to investigate HDR monotherapy given as either one fraction of 19     Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint     is patient reported toxicity and health related quality of life at 1 year, and efficacy data     will be also be analyzed. Sample size for the study is 174 patients, which we expect to     accrue within 18 months.   "
106649|NCT01890083|"     Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α     treatment results in a significant increase in depressive symptoms. The aim of this project     is to compare two health interventions (exercise vs. health education) to prevent depression     in HPC patients receiving IFN-α. Participants will be recruited from the Clinical Center for     Liver Diseases at UT-Southwestern and randomized to 26 weeks of either: aerobic exercise or a     health education control group.   "
106650|NCT01890070|"     The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods     conforming to the Mediterranean diet, in order to determine the effect functional foods have     on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function,     inflammation, nutritional status) and body composition in the context of four different diets     (standard, high fat, high protein, low carbohydrate). The study focuses on the effect of     these nutraceutical foods in relation to different diets. Diets were chosen to reflect the     standard reference diets used by the general population, so as the outcomes of the addition     of each interventional food element may be interpreted in the context of a variety of dietary     patterns.   "
106651|NCT01890057|"     To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from     profound rocuronium-induced neuromuscular block in young and elderly adult patients.   "
106652|NCT01890044|"     Venous thromboembolism (VTE) remains a leading cause of death in trauma patients. Based on     the EAST Management Guidelines for the prevention of VTE in trauma patients, a number of     research questions could be addressed by a thorough current literature review combined with a     multicenter concurrent analysis. This proposal seeks to create a data registry of trauma     patients from multiple trauma centers around the United States that will serve as a platform     for the study of VTE.   "
106653|NCT01890031|"     The purpose of this study is to show that we can effectively deliver health information and     education, online, via computer regarding cholesterol. This computer program is called the     Interactive Cholesterol Advisory Tool (ICAT).   "
106654|NCT01890018|"     The overall objectives of this study are to improve medication adherence of patients and     subsequent health outcomes.      This study is designed to examine the existence of strong associations between social     networks and health behavior. This study intends to demonstrate that social forces are     particularly effective at building enduring habits for healthy behavior, specifically     adherence to statin medication for this study. The investigators believe the improved     medication adherence will result in fewer additional vascular events, following the most     recent of these events, and will result in fewer patient hospitalizations. The investigators     will leverage insights from the fields of social comparison (being provided with information     about the actions of others prompts social comparison that can significantly influence     behavior), social pressures (encouragement or discouragement from others is a powerful social     force that can influence individual behavior), and social triggers (cues in the environment     can motivate people to take certain actions and have powerful effects on purchasing     behavior).      The results of this study and experience gained from the implementation of these     interventions will be used to inform new versions of a larger trial intervention to be tested     in new patient cohorts in a rapid cycle framework.   "
106655|NCT01890005|"     Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over     the world. The use of low dose aspirin has been mentioned in several studies with promising     results. The investigators decided to evaluate the use of low dose aspirin, starting between     13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence     of preeclampsia.   "
106656|NCT01889992|"     Cardiac allograft remodeling causes poor quality of life, allograft failure and increased     mortality after heart transplantation. Risk factors for cardiac allograft remodeling and its     progression are poorly defined and there is a need for effective interventions.This is a     multi-factorial phenomenon, associated with various immunological and non-immunological     factors. Animal studies suggest M-TOR inhibition attenuates cardiac allograft remodeling     secondary to down-regulation of M-TOR downstream targets and increased autophagy. There is a     paucity of data regarding effect of Sirolimus, a M-TOR inhibitor, on human heart remodeling.      This aim of the proposal to identify the prevalence of cardiac allograft remodeling on     current immunosuppressive strategies and determine risk factors for its development. It will     also identify molecular pathways associated with cardiac allograft remodeling and determine     the impact of Sirolimus on these pathways.   "
106657|NCT01889979|"     Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately     severe pain. It has been previously evaluated as a method to reduce pain during labour, but     there is always some fear related to its effects (neonatal respiratory depression). The     purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain     during labour, duration of labour and neonatal outcomes.   "
106658|NCT01889966|"     Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary     hypertension it is approved for treatment. The trial seeks to find out, whether the acute     response to this treatment (= vasoreactivity testing) given intravenously is effective and     allows prediction of therapy success during a following oral treatment.   "
106659|NCT01889953|"     This research is being done to study the safety and feasibility of recruiting patients     eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety     and effectiveness of this procedure.   "
135178|NCT01515462|"     This is phase I/II protocol to evaluate the safety and efficacy of WAS gene transfer into     hematopoietic stem/progenitor cells for the treatment of Wiskott Aldrich Syndrome.   "
106660|NCT01889940|"     The purposes of the ESPELMA project are twofold: 1) To increase acute spinal cord injury     patients' satisfaction with treatment while hospitalization and 2) To increase mastery among     rehabilitation professionals with regard to the clinical management of patients'     psychological distress.      For these purposes, a tailored training for professionals will be designed and offered.      It is hypothesized that building capacity among professionals will serve to better management     of patients' distress and a greater ability to commit them to the rehabilitation process.     Thus, it is expected to lead to better and faster functional recovery and consequently to     higher perceived satisfaction with treatment.   "
106661|NCT01889927|"     The primary aim of the research is to evaluate whether an alternative model of cystic     fibrosis (CF) physiotherapy care can produce statistically significant improvements in     clinical and patient reported outcomes, and whether this alternative model is economically     advantageous and/or sustainable.      Children randomised to the control group will receive 24-months of current model of CF care     at Great Ormond Street Hospital (GOSH).      Children randomised to the intervention group will receive 24-months of current model of CF     care at GOSH PLUS a weekly structured, individually prescribed and personally supervised     exercise intervention at a local fitness facility or at school. The exercise prescription     will include aerobic, anaerobic, strength, core conditioning and stretching components.      The main objectives of the study are:        1. Determine differences, if any, in lung function between the two groups;        2. Determine differences, if any, in exercise capacity between the two groups;        3. Evaluate cost of care of alternate model of care versus current model of care.   "
106662|NCT01889914|"     The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.      In our future study, the investigators wish to study if the treatment by continuous infusion     of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators     indeed expect that the insulin delivered in a continuous way decreases the     insulino-resistance of these patients compared with the intermittent delivering of insulin.   "
106663|NCT01889901|"     Epilepsy is common in childhood. Throughout life, including adulthood, children with epilepsy     are at increased risk of impaired health, functioning, psychological well-being and     quality-of-life. There is evidence that physical activity improves the medical and     psychosocial aspects of health in adults with epilepsy- but there are no such studies in     children. The investigators predict that we can increase levels of physical activity and     influence children's functioning, psychological well-being and quality of life through     multiple pathways. The investigators propose to evaluate the relationship between enhanced     physical activity and health, and explore facilitators and barriers to physical activity in     children with epilepsy.   "
106664|NCT01889888|"     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System     (Cytori Therapeutics Inc)from a portion of the fat harvested from the patient's front     abdominal wall. ADRC will be administered one-time endoscopically into submucosal layer of     urethra under eye control into the stricture site after mechanical dilation. This is a single     arm study with no control. All patients receive cell therapy.   "
106665|NCT01889875|"     Treatment of pollen allergies can be roughly divided into symptomatic treatment (e.g.     antihistamines, steroids) and potentially curative immunotherapy. Immunotherapy can be     delivered using subcutaneous or oral (mucosal) routes, with similar clinical outcome. The     study seeks to compare immunological changes during subcutaneous (SCIT) and sublingual tablet     (AIT) immunotherapy of grass pollen allergy (hayfever).   "
106666|NCT01889862|"     The BMN 165 clinical development program has been designed to demonstrate the safety and     efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.   "
106667|NCT01889849|"     This research protocol Comparative pharmacokinetics and pharmacodynamics of peginterferon     Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy     volunteers. This is a Phase I clinical trial which will compare pharmacokinetic and     pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®) and     BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of 4     weeks. The study population will be 32 healthy male volunteers to whom will be administered a     single dose of 180 microgram of each product, subcutaneously. The study will have a total     duration of 14 days in each treatment step. The serum concentration of PEG-interferon for     both products, measured by enzyme immunoassay (EIA) and by antiviral activity of     PEG-interferon, is the main variable.For this purpose 15 samples of each volunteers will be     needed. Clinical and laboratory variables, useful as pharmacodynamics parameters Beta-2     microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate synthetase (OAS)- and     neopterin) and safety evaluation, will be measured.   "
106668|NCT01889836|"     Clinical trial phase I, randomized, double blind, where 30 individuals will receive the     experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate     vaccine already licensed in Brazil and available in the National Immunization Program for     children less than 12 months of age. The primary outcome of the study is to evaluate the     safety profile of the vaccine under test, which should allow its application in humans.     Secondly, the investigators will study its immunogenicity from the evaluation of the     correlates of seroprotection for meningococcal, defined by the World Health Organization     (WHO).   "
106669|NCT01889823|"     It has been shown in in vitro and animal models that hypoxia can have pro-inflammatory     effects and hyperoxia can have anti-inflammatory effects. The pro-inflammatory effect could     be the result of activation of Hypoxia Inducible Factor, a transcription factor that is known     to activate many cell systems aimed at cell survival, including the inflammatory response.     The anti-inflammatory effects of hyperoxia could be the annihilation of Hypoxia Inducible     Factor, but also a decrease in inflammation due to oxygen toxicity resulting in a decrease in     clearance of pathogens. These effects have been sparsely studied in humans. Therefore, we     hypothesize that hypoxia results in an increase in Hypoxia Inducible Factor in circulating     leukocytes and increases inflammatory reactions, whereas hyperoxia decreases these reactions.   "
106806|NCT01888042|"     It is a an open label, multicentric, phase II study assessing the efficacy of everolimus     (given per os) as a first line treatment in kidney cancer of bad prognosis.      92 patients will be included (anticipated). The treatment by everolimus will continue until     progression, significant toxicity or withdraw of consent   "
135179|NCT01515449|"     The aim of the project is to ascertain the pre and intra operative predictors of poor     outcomes in total knee replacement.   "
106670|NCT01889810|"     Insulin resistance is a state where the body does not respond as it should to the insulin it     produces. Individuals who are insulin resistant are at increased risk of both heart disease     and type 2 diabetes; importantly, diabetes more than doubles the risk of heart disease,     independent of other recognised risk factors. Interventions that prevent or reverse insulin     resistance may help to attenuate risk of heart disease and diabetes. A number of randomised     controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin     D on insulin resistance and other cardiovascular risk markers but experts have stated that     further studies are required. Importantly, these studies should use appropriate endpoints,     provide a high enough dose of vitamin D to optimise vitamin D status, and they should be     conducted in clearly defined populations, The vitamin D trial we propose addresses these     issues and aims to evaluate a potentially straightforward and low cost health care     intervention for populations at highrisk of heart disease and diabetes. Specifically, this     study would provide clinically relevant information on the metabolic effects of optimising     vitamin D status in these high risk patients. This has clear economic and social implications     given the current, and projected, burden of heart disease and diabetes.      This study will investigate the effect of vitamin D3 supplementation on insulin resistance     and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular     disease using the gold standard euglycaemic hyperinsulinaemic clamp method.   "
106671|NCT01889797|"     Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL)     will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine     response.      Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug     Administration in 1998 for the treatment of patients with relapsed low-grade B-cell     lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and     effective in previously untreated as well as relapsed patients with low-grade lymphoma.      GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been     shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death     induction compared to Rituximab. It is possible that GA101 may have greater efficacy than     rituximab.      PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in     Patients Participating in GA101 (Obinutuzumab)      Approximately twenty-five patients randomized to GA101 may participate in the sub-study.     Electrocardiograms and blood samples will be obtained.   "
106672|NCT01889784|"     The purpose of this study is to determine the phototherapy may be adjuvant to exercise to     improve muscular efficiency and increase aerobic capacity. We hypothesized that phototherapy     adjuvant with physical exercise may be benefit to populations with Diabetes mellitus that     have impairment in cardiopulmonary fitness and low oxygen uptake peak values (VO2peak) in     exercise tests. Two doses will be tested 150J and 300J.      Additionally, this study aims to evaluate the effect of phototherapy previously applied to     the exercise on the cardiovascular coupling. We hypothesize that phototherapy previously     applied to the exercise will result in the increase baroreflex sensitivity (increased     coherence and gain and decreased phase), promoting the improvement of the cardiovascular     autonomic control and cardiovascular coupling in diabetic subjects. Two doses will be tested     150J and 300J.   "
106673|NCT01889771|"     The study is to understand whether distribution of two different supplies of nicotine patches     through a telephone quitline has an effect on quit rates. The two different supplies are four     vs. eight (in two separate four-week mailings) weeks of nicotine patches. The hypothesis is     that eight weeks will be slightly more efficacious but four weeks will be more     cost-effective.   "
106674|NCT01889758|"     The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the     two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated,     3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.   "
106675|NCT01889745|"     This study is designed to multiple dose and dose escalation study   "
106676|NCT01889732|"     Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation     disorder undergoing surgery. Recently, there are some reports about prediction of     perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and     improve outcomes is still debate. In this retrospective study, the investigators will compare     immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access     the reliability of ROTEM for prediction of bleeding after cardiac surgery.   "
106677|NCT01889719|"     This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are     safe and whether they will boost immune responses generated by immunizations with a dendritic     cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected     volunteers.   "
106678|NCT01889706|"     The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and     excess weight. This leads to the development of insulin resistance, even in patients with     type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as     adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in     overweight and obese patients with type 1 diabetes mellitus.      The study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose     tissue content as measured by electrical bioimpedance, treated at the Poznan University of     Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes     diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This     group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100     patients are treated with insulin alone (control group, group I). Metformin is administered     at least 6 months at a mean dose of 1000 mg/day.      The investigators would like to assess the impact of metformin treatment on metabolic     control, insulin resistance and anthropometric parameters in overweight and obese patients     with type 1 diabetes.   "
106692|NCT01889524|"     In vivo deposition studies of aerosol administration during noninvasive ventilation are     scarce in the current literature.      We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy     aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the     different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered     using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive     ventilation (NIV).   "
145278|NCT01382810|"     The purpose of this study is to evaluate and compare the effects of Altaire Gel forming     solution and Refresh Tears in mild-moderate dry eye patients.   "
106679|NCT01889693|"     Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with     positron emitter is not yet available. Fortunately, some scientists made the major advance in     the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter agent     18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque macrophages in     carotid arteries. However, coronary and cerebral arterial segments remain uninterpretable due     to metabolic property of 18F-FDG. Applying the character of the terminal mannose residues of     MSA binding with the mannose receptors of macrophages in atherosclerosis, we investigate     whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of atherosclerotic     lesion in PET.   "
106680|NCT01889680|"     FC-8 is a Phase II, multi-center randomized study of a continuation regimen of 5-FU/LV with     ziv-aflibercept or 5-FU/LV alone (control arm) following the induction regimen of mFOLFOX6     and ziv-aflibercept as first-line therapy for patients with metastatic colorectal cancer. The     primary aim of the study is to determine the value of adding ziv-aflibercept to the     continuation regimen of 5-FU/LV in improving progression-free survival (PFS) of patients with     metastatic colorectal cancer who have achieved at least stable disease after induction     therapy. The secondary aim is to determine the overall objective response rate (complete,     partial or stable responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).   "
106681|NCT01889667|"     The purpose of this study is to test the safety and pharmacodynamics of an oral formulation     of insulin in subjects with Type 2 Diabetes.   "
106682|NCT01889654|"     Lupus disease is characterized by the production of pathogenic autoantibodies, which     participate in end-organ damages. The phenotype of B cells producing the pathogenic     autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are     characteristic of lupus disease.This project proposes to detect antinucleosome B cells in     lupus patients and to analyse their phenotype and their frequency.   "
106683|NCT01889641|"     Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy,     underscoring the need to better dissection of the pathogenic mechanisms. Concordant with     preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could     be a marker of the disease activity and then a potential therapeutic target. In the present     study, serum IL 26 level in lupus patients and control will be measured.   "
106684|NCT01889628|"     Nutritional formula drinks are widely consumed in Asia especially by those having chronic     illnesses such as diabetes. Therefore, gauging the impact of nutritional formulas on blood     glucose levels is very important. Asia is home to three predominant ethnic groups- Chinese,     Malay and Indians. It is still unknown if the blood glucose response to nutritional formulas     differs between ethnic groups. Therefore the aim of this study is to observe if there are     ethnic differences in the blood glucose response to nutritional formula drinks.   "
106685|NCT01889615|"     The investigators want to compare the use of MRI with PET/CT preformed after 1 hour and 3     hours in preoperative assessment of resectability.      The investigators' hypothesis is that dual time PET/CT performed at 60 and 180 minutes will     increase the diagnostic accuracy of conventional PET (performed at 60 minutes) in     preoperative assessment of resectability.      Further more the investigators suggest that the GLUT/G6Pase index correlates to the SUVmax.     And retention index (RI, see Methods - PET protocol) is a prognostic marker in ovarian     cancer.   "
106686|NCT01889602|"     Cognitive impairment is a widely reported side effect of many commonly used drugs. Even a     mild, untoward effect on an essential function such a linguistic behavior, a directly     observable product of complex cognitive processes, is disruptive to daily life. Nevertheless,     the mechanisms underlying a drug's impact on cognition are poorly understood. This lack of     understanding impedes the ability to predict both the effects of drugs in development and the     degree to which an individual is vulnerable to the cognitive impact of a particular agent.     Topiramate (TPM, an antiepileptic drug) is, with increasing frequency, being prescribed for a     range of conditions including migraine prophylaxis, obesity and pain. It is a prime example     of a drug that causes speech and language problems severe enough in some patients to result     in discontinuation of therapy. For reasons not well understood, TPM has a poorer cognitive     profile than many of the older antiepileptic drugs. The investigators' rational for this     study is that it will offer insight into the mechanisms underlying drug-induced cognitive     deficits.   "
106687|NCT01889589|"     This surveillance project will assess NYC population sodium intake using the gold standard     measurement of 24-hour urine collection. This surveillance project is a critical component of     a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary     industry reductions in processed food sodium content. The project will assess current     population sodium intake, against which population intake changes at three years can be     assessed   "
106688|NCT01889576|"     Hypomagnesemia is common early after transplantation, especially in association with     calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves     glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without     diabetes but this was never evaluated in transplant recipients.      The aim of the study is to assess whether magnesium improves glycemic control and insulin     sensitivity early after transplantation.      The study is an open label study in which adult hypomagnesemic renal transplant recipients     are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no     supplementation.      The hypothesis is that magnesium supplementation in renal transplant recipients exerts a     beneficial effect on glycemia and the development of diabetes after transplantation.   "
106689|NCT01889563|"     To contrast the potential effects of physical exercise training program (PTP) of a 6 versus     12 weeks on cardiac autonomic modulation by linear and non-linear heart rate variability     (HRV) indices and functional capacity in moderate-to-severe COPD patients.   "
106690|NCT01889550|"     The research aims at generating new knowledge about ways to inform pregnant women about     prenatal screening for Downs syndrome.      The overall purpose of this project is to increase pregnant women's knowledge of prenatal     screening for Downs syndrome, and thereby an option to make an informed choice. The project     is planned as a research into whether the use of an eHealth solution (in this project an     interactive website) may be an appropriate intervention for pregnant women.   "
107208|NCT01882803|"     Phase 2 clinical trial to evaluate the safety and efficacy of IPI-145 as a monotherapy in     subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic     Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT.   "
106693|NCT01889511|"     The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale     health-related research project on text messages to improve adherence to oral chemotherapy     agents. Michigan State University College of Nursing has not been a major recipient of     National Institute of Health grant funding. As a result, the overall objective of this     proposal is to strengthen the research environment in the College of Nursing so that it can     develop into a significant health-related scientific research enterprise. This project would     involve undergraduate and graduate students, and thus, generate student interest in research     as a career. The importance of the research planned for this proposal is as follows. More     than 50 oral chemotherapy agents in pill form are currently on the market, with projections     that in 3 years, 25% of cancer treatments will be delivered in pill form. For oral agents to     achieve a therapeutically effective level for cancer treatment, patients must strictly adhere     to the regimen. Adherence to oral cancer agents is often less than 80%, which may be     inadequate for treating the cancer. To date, empirical research in the area of improving     adherence to oral agents is underdeveloped. The goal of this research is to improve adherence     to oral chemotherapy agents through a technology based strategy, tailored SMS text messages.     This prospective randomized controlled trial will examine the feasibility, acceptability, and     satisfaction with a 3-week tailored text message intervention for oral agent adherence.     Descriptive statistics, generalized linear modeling, and generalized estimating equations     will be used for analysis. In this proposal, preliminary data will be collected to examine     efficacy of the text message intervention to promote adherence to oral agents. Data will then     be used to further inform the development of an intervention to improve adherence to oral     agents for an R01 application to conduct a larger randomized trial to test this innovative     intervention. This study can have a transformative impact on oral agent adherence by     developing a technology-based strategy to promote adherence among the increasing number of     cancer patients who receive their cancer treatment in pill form. This type of novel     intervention also has the potential to transform and impact many other ill populations that     require adherence to a medication regimen.   "
106694|NCT01889498|"     The aorta is a large vessel that carries blood away from the heart. Sometimes it becomes     dilated (swells) and this is known as 'aneurysm'. It may cause either dissection (splitting     of the wall) or rupture (bursting).      Treatments could be through open surgery or by use of stents (tubular mesh) through the     groin. There is a risk of causing paraplegia, which is the loss/weakness of leg function as     well as incontinence (loss of bladder and/or bowel control).      To try and prevent this, a number of techniques are used such as removing/draining of     cerebrospinal fluid (CSF) (the clear fluid surrounding the brain and spinal cord).      Sometimes however;        -  CSF cannot be drained        -  drain cannot be inserted        -  draining is unlikely to improve the situation        -  Paralysis/weakness of the leg is seen      In these situations, the use of a drug called acetazolamide may be helpful. This reduces the     production of CSF and therefore decreases the need for CSF draining. It may also have an     effect in decreasing the risk of paraplegia.      Patients will be randomly (by chance) placed into one of two groups. One will get the drug as     tablets and injection and the other will not receive any acetazolamide at all. Blood tests     will be done in both groups. We expect to have 100 patients in the study, with patient     involvement for a total of 10 days (maximum).   "
106695|NCT01889485|"     This is a pilot study designed to validate our methods of recruitment, screening and data     collection in the community. The project will help to establish the feasibility of the study     design to lay the groundwork for a potentially larger study. The final study will allow us to     estimate the incidence and prevalence of abdominal aortic aneurysm (AAA), carotid artery     stenosis, and peripheral artery disease (PAD) in different geographic areas in a large urban     setting, as well as determine patient access to healthcare and treatment for vascular disease     as related to geographic and racial differences.   "
106696|NCT01889472|"     CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used     in case of mouth leaks but these are associated with higher positive pressure needs and lower     compliance to treatment. The present investigation evaluates if CPAP compliance would     increase when an oral appliance is used in combination with a nasal mask compared to the use     of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using     an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one     of the above-detailed interfaces for 4 weeks and data will be extracted from the machine     report in each condition.   "
106697|NCT01889459|"     The purpose of this study is to establish a consensus of treatment strategy of percutaneous     coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI     for CTO performed by Japanese certified operators.   "
106698|NCT01889446|"     Propionic acid (PA) is used as a preservative in foods such as cheeses, baked goods, or     additive for artificial fruit flavors. The U.S. Environmental Protection Agency considers it     safe and therefore, has no limitation on its use. Since PA has been shown before to serve as     a substrate for glucose production in the liver, the purpose of this study is to find out if     PA intake causes changes in levels of glucose, insulin and other important hormones following     a meal.      This research study will compare PA to placebo. The placebo looks exactly like the active     substance, but it does not contain any active agent (PA). Placebos are used in research     studies to see if the results are due to the study drug or to other reasons.      The investigators plan to have 20 subjects take part in this study at the Brigham and Women's     Hospital (BWH).   "
106699|NCT01889433|"     The purpose of the study is to demonstrate the noninferiority of Algeron in combination with     ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic     hepatitis C.   "
106700|NCT01889420|"     This study is being conducted to test the possibility that a combination of three drugs,     pomalidomide and everolimus with dexamethasone, may improve patient responses when compared     with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.   "
106701|NCT01889407|"     Whether Idarubicin can overcomes multidrug resistant 1 induced chemoresistance with higher     induction remission rate than daunorubicin in de novo acute myeloid leukemia patients.Whether     induction therapy with IA regimen has a higher remission quality with AML patients than that     of DA regimen in high MDR1 expression AML patients.   "
106723|NCT01889121|"     Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance     program enhances the outcome of pregnancies for the mother and the infant. Our objective was     to assess if provision of structured psychosocial support in addition to methadone     maintenance program adds incremental benefits with regards to the outcome of pregnancy.   "
106807|NCT01888029|"     The aim of this study is to investigate whether the anodal transcranial direct current     stimulation (tDCS) over the primary motor cortex (M1) in patients with mild cognitive     impairment (MCI) leads to an increase in cortical plasticity (change in motor evoked     potentials (MEP) in mV).   "
106962|NCT01886014|"     Placebo responses contribute to medical treatment outcome. The purpose of this study is to     determine whether a single intranasal application of oxytocin can increase the placebo     response in an experimental model of placebo analgesia in healthy volunteers.   "
106703|NCT01889381|"     Background: The human face is critically important for breathing, eating, seeing, and     speaking/ communicating, but its most important job may be to look like a human face.     Devastating facial deformities often cause affected individuals to avoid human contact and     disappear from society. Although current surgical advancements can somewhat restore facial     defects, this process often requires many operations and the resulting face only resembles     the human face. To date, over 20 face transplants have been performed with highly encouraging     functional and aesthetic results, but widespread clinical use has been limited due to the     adverse effects of life-long and high-dose immunosuppression needed to prevent graft     rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly     affect recipients' quality of life, make the procedure riskier, and jeopardize the potential     benefits of face transplantation.      Study Design: This non-randomized, Phase II clinical trial will document the use of a new     immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face     transplantation as a safe and effective reconstructive treatment for devastating injuries/     defects by minimizing maintenance immunosuppression therapy in face transplant patients. This     protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled     graft survival using low doses of a single immunosuppressive drug followed by weaning of     treatment. Initially designed for living-related solid organ donation, this regimen has been     adapted for use with grafts donated by deceased donors. The investigators propose to perform     15 full or partial human face transplants employing this novel protocol.      Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive     strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of     rejection and enable allograft survival while minimizing the requirement for long-term,     high-dose, multi-drug immunosuppression.      Significance of Research: Face transplantation could help injured individuals recover     functionality, self-esteem, and the ability to reintegrate into family and social life as     whole individuals. This protocol offers the potential for minimizing the morbidity of     maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this     life-enhancing procedure and enabling a wider clinical application of face transplantation.   "
106704|NCT01889368|"     In people with the metabolic syndrome, the investigators hypothesize that administration of a     single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well     cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized     LDL in the blood during a 24 hour period. These measurements will be assessed at hourly     intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize     that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin     resistance, oxidative stress, and the level of oxidized LDL in the blood.   "
106705|NCT01889355|"     This enhanced meter feature raises awareness among patients by providing additional     information regarding their glycemic control in between Healthcare Professional visits. This     information may facilitate increased dialogue between patient and Healthcare Professional and     can remind patients of the importance of glycemic control.      This study will evaluate a user's ability to use the enhanced meter feature.   "
106706|NCT01889342|"     Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic     model and could therefore be well suited when it comes to treating patients with high rates     of comorbidity. So far, no studies have examined MCT in comparison with the best documented     and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized controlled     trial consisting of mixed anxiety disorder sample with high degree of comorbidity.      The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a     sample of mixed anxiety disorders as compared to a group receiving existing evidence-based     single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change in     the two treatments.   "
106707|NCT01889329|"     Around 0.5 million under-five children are currently suffering from severe acute malnutrition     (SAM) in Bangladesh and are at risk of death. Children with SAM and complications should be     treated in a health care facility. It is imperative, however, to manage children with SAM but     without any complications in the community. This requires a ready-to-use-therapeutic food     (RUTF) that conforms to standard recommendations on its composition. The prototype RUTF is     peanut based, made outside Bangladesh, and has to be imported. By developing a RUTF using     local food ingredients, test it for acceptability and efficacy in the treatment of children     with SAM, hopefully make the treatment of SAM cost-effective and sustainable.      Hypothesis: Does the locally developed ready-to-use-therapeutic foods (RUTFs) demonstrate     similar or better acceptability and efficacy in the treatment of children suffering from     severe acute malnutrition (SAM) when compared to the prototype RUTF (Plumpynut)?   "
106708|NCT01889316|"     This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing     in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii     (a newer device also created by Monica Healthcare) using the same technology with different     monitor placement.   "
106709|NCT01889303|"     Concurrent chemoradiotherapy has been demonstrated a significant improvement in overall     survival and disease-free survival according to Intergroup Trial 0116 in patients with     gastric cancer after surgical resection. However,there are still many patients experiencing     local recurrence or distant metastasis after adjuvant chemotherapy and concurrent     chemoradiotherapy for locally advanced gastric cancer after resection. The optimal and     standard regimen for adjuvant treatment has not been established in locally advanced gastric     cancer yet.The investigators designed the trial to investigate the efficacy and safety of     docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy     regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as     chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical resection.   "
106710|NCT01889290|"     -  Assessment of pharmacokinetic parameters of once daily subcutaneously administered          methylnaltrexone in 10 evaluable neurointensive care patients.        -  Quantification of methylnaltrexone passage through the blood-brain-barrier in critically          ill patients with severe cerebral affections.        -  Observation of laxation response after methylnaltrexone application and relation to          plasma concentrations of methylnaltrexone.        -  Assessing the safety of once daily administered methylnaltrexone in neurointensive care          patients.        -  Trial with medicinal product   "
106711|NCT01889277|"     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995     in Subjects with Diabetic Nephropathy   "
106735|NCT01888965|"     This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had     surgery to remove metastases and patients with pancreas cancer, which has been surgically     removed and are receiving adjuvant chemotherapy or is locally advanced and have already     received chemotherapy and radiation.      The purpose of this study is to determine the effects of oral dovitinib in patients with     advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free     survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to     2 years.   "
106712|NCT01889264|"     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and     protein. Protein synthesis is increased mainly in the form of immune and signaling proteins,     while muscle and structural protein synthesis is decreased. The metabolism of sulfur amino     acids through the splanchnic area and specifically methionine and cysteine have not been     investigated in critically ill septic children, despite that sulfur amino acids have     important roles in thiol, antioxidant and epigenetic reactions. Methionine metabolism in sick     children will be influenced by its rate of utilization through different pathways. Our study     aims to investigate the metabolism of methionine and cysteine when both amino acids are given     by the enteral route in critically ill septic children. The investigators are focused on the     rates of transmethylation, remethylation and transsulfuration in critically ill septic     children, and if the current standard nutrition maintains methionine nutritional balance and     functional requirements in critically ill children fed by the enteral route.   "
106713|NCT01889251|"     The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion     (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to     sham-injection in subjects with symptomatic VMA.   "
106714|NCT01889238|"     The purpose of this study is to determine if enzalutamide is safe and effective in the     treatment of patients with advanced breast cancer that express the androgen receptor but do     not express the estrogen or progesterone receptor and are not Her2 amplified.   "
106715|NCT01889225|"     Previous analyses of the National Health and Nutrition Examination Survey have suggested that     the mortality rate associated with obesity has decreased over calendar time in the U.S.     population, potentially due to improvements in the medical care of obesity and its associated     diseases. The primary aim of this project is to evaluate whether this reduction in the     detrimental association of obesity with mortality rate over calendar time is supported by     other data from U.S. prospective studies.   "
106716|NCT01889212|"     New treatment strategies have been developed in lung cancer targeting the Epidermal Growth     Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds     rates to the treatment and should be treated with a EGFR inhibitor as first line of     treatment. Some wild type patients do as well respond but selection of these patients is more     difficult.      Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer     (11C-erlotinib) in tumors has showed promising results for selection of responders.      The investigators now want to conduct a larger clinical study to evaluate if accumulation of     tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.   "
106717|NCT01889199|"     The purpose of this research study is to collect specimen samples and study medical     information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal     is to learn more about the changes that take place in the body that result in PCOS.      We anticipate that 59 women will take part in this study (15 without PCOS and 44 with PCOS).     All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If     they meet the criteria for this study, they will then undergo additional blood tests, removal     of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., MRI,     DXA scan), a modified frequently-sampled intravenous glucose tolerance test (FSIGTT), and     determination of ovarian function (via a follicle stimulating hormone [FSH] test). The women     without PCOS will be complete the study at this point.      The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo.     They will take the drug every day for six 28-day cycles. They will be asked to collect and     store a urine sample once a week. They will also be asked to complete a pill diary and     menstrual diary. Once a month while they are taking the flutamide/placebo, they will return     to the clinic and bring their frozen urine samples. At that time they will undergo a physical     exam, toxicity assessment, and blood draw.      Quality of Life assessments will be done at the beginning of the study for all participants.     Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality     of Life assessments during the study and at the end of the study.      Six months following the completion of protocol procedures, participants who received     flutamide/placebo will be contacted by phone to check on the status of their health. They     will be asked if they have experienced any health problems or have become pregnant since they     completed the study procedures.      After the six 28-day cycles are completed they will then undergo additional blood tests,     removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat     (i.e., MRI, DXA scan), a modified frequently-sampled intravenous glucose tolerance test     (FSIGTT), and determination of ovarian function (via a FSH test).   "
106718|NCT01889186|"     This is a Phase 2, open label, multicenter, study evaluating the efficacy and safety of     ABT-199 in relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion.     One hundred seven (107) subjects were enrolled in the main cohort, with evaluation of     efficacy as the primary objective, and approximately 50 subjects will be enrolled in the     safety expansion cohort to evaluate safety and updated tumor lysis syndrome prophylaxis and     management measures. Enrollment into the main cohort is closed. Enrollment into the safety     expansion cohort is closed.   "
106719|NCT01889173|"     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for     bedtime use. The present trial is designed to assess the safety and tolerability of 3     different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine     designed to result in increased dosage precision and decreased potential for morning     grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg     SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C     with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).   "
106720|NCT01889160|"     Study to investigate the safety profile of AZD4721 after single doses at different dose     levels   "
106721|NCT01889147|"     In the present study human recombinant placental alkaline phosphatase (hRESCAP) will be     investigated. Alkaline Phosphatase is naturally present in the body and reported to use     lipopolysaccharde (LPS, bacterial endotoxins) and extracellular nucleotides leaking from     damaged and ischemic cells as physiological substrates. The LPS-substrate prevalence makes     alkaline phosphatase an interesting novel therapeutic agent in the treatment of LPS-mediated     diseases. A bovine homologue of this protein (bovine intestinal alkaline phosphatase, BIAP)     has previously been investigated for treatment of acute inflammatory responses such as     sepsis, and was shown to be safe in humans. hRESCAP, which will be investigated in the     current study, is expected to have a longer half-life in humans than the previously     investigated BIAP, due to the fact that it is more sialylated. The possibility to increase     the t1/2 to days instead of minutes enables treatment of chronic diseases.   "
106722|NCT01889134|"     The purpose of this study is to determine whether osteoprotegerin and RANKL (receptor     activator of nuclear factor-κB ligand) are involved in bone remodeling in patients with     primary hyperparathyroidism (PHPT), and whether alendronate may be useful in treatment of the     patients with PHPT who are not treated with parathyroidectomy.   "
106770|NCT01888510|"     This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer.     Diagnostic procedures, such as CT, may help find and diagnose lung cancer.   "
106724|NCT01889108|"     The proposed feasibility study will evaluate the investigators ability to conduct a clinical     trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature.     Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from     current early intervention practices in 2 important ways. First it bridges the traditional     gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and     intensive support for developmental activities when parents are establishing care giving     routines. Second, in contrast to wide-ranging intervention provided by current early     intervention models, SPEEDI uses an action perception model to target specific behaviors     which lead to improved early motor abilities and provide a foundation for learning.[6] The     purpose of this feasibility study is to extend the investigators preliminary data and     evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of     SPEEDI.   "
106725|NCT01889095|"     Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle     intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail     to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are     generated to improve glycemic control .New insulin analogs are generated to improve glycemic     control,However, the cost of these analogs is a major problem .The aim of this piggy back     evaluation was to assess the effect of BIAsp 30 versus NPH plus regular human insulin on     metabolic control as well as its cost-effectiveness in people with type 2 diabetes in the     Iranian setting.   "
106726|NCT01889082|"     A randomized pilot study will be conducted, the goal of which is to determine which format     represents the most viable approach to behavioral weight loss treatment with 18-25 year olds.     Specifically, participants will be randomized to one of three arms; all arms will receive a     12-week behavioral weight loss intervention, including identical dietary, physical activity,     and weight loss prescriptions.   "
106727|NCT01889069|"     This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic     (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of     differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy,     participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the     Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during     the Maintenance period.   "
106728|NCT01889056|"     The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the     brain, especially under hypoxic conditions. It has been shown in animal studies and human     studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence     for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome     the blood brain barrier. In a double blind placebo controlled crossover study we will     investigate the effects of a single high dose of Epo on cognitive function and exercise     capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU)     and will perform a computerized cognitive test battery, a breathing test, a maximal exercise     capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary     outcome of the study will be the cognitive function.        -  Trial with medicinal product   "
106729|NCT01889043|"     Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in     patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be     impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research     has been performed on the quality of sleep in patients with ALS when using NIV, and these     data are mainly based on patient reported outcomes.Further on, only very little research has     been done on patient-ventilator interaction.      Our study would like to perform research on quality of sleep before and after NIV use by     using full polysomnography with incorporation of transcutaneous carbon dioxide measurement     and built-in ventilator software.   "
106730|NCT01889030|"     This is an observational, cross-sectional, national multicenter study, trying to obtain local     data about the global cardiovascular risk profile of patients attending ambulatory offices of     general practitioners and cardiologists.      The aim of the study is to describe how physicians diagnose and stratify their patients in     cardiovascular primary prevention setting and to highlight if patients are stratify through     objective tools (risk scores and in this case, wich of them are used) or in subjective ways     (clinical evaluation).   "
106731|NCT01889017|"     Extent of use of generics immunosuppressive drugs in clinical practice after lung     transplantation   "
106732|NCT01889004|"     The explanation of consciousness poses one of the greatest challenges to science and     philosophy in the 21st century. It remains unclear what consciousness is and how it emerges     from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what     happens in the brain when consciousness is lost and when it returns. During the study, a     series of Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and     electroencephalography (EEG) studies will be carried out on healthy male subjects to reveal     the neural correlates of consciousness. Consciousness of the subjects will be manipulated     with normal sleep and anesthetic agents dexmedetomidine and propofol.      First, various neurophysiological tools to separate consciousness, connectedness and     responsiveness during normal sleep will be tested. The most suitable methods and subjects     will be selected and then tested during anesthetic-induced sedation and loss of     responsiveness (LOR). The anesthetics (dexmedetomidine or propofol) will be administered as     target-controlled infusions (TCI) with step-wise concentration-increments until LOR is     detected. Then, TCIs are repeated in the same subjects but adjusted according to the     individual drug target concentrations sufficient for LOR, and a series of PET perfusion     imaging measurements will be performed to obtain the brain activity information in various     states of consciousness. The same subjects will then be imaged with PET for brain activity     after sleep deprivation (awake), during various sleep stages and immediately after awakening.     Finally, ten dexmedetomidine subjects will be given the drug once more, and functional MRI     (fMRI) data will be collected at various states of consciousness before and during verbal and     nonverbal vocalizations. EEG will be continuously collected in all sessions. The depth of     anesthesia will be measured using quantitative EEG and bispectral index (BIS) monitoring.      The results may lead to the discovery of new and better objective indicators of the depth of     anesthesia and consciousness, and new insights into the understanding of neural mechanisms     behind drug-induced loss of consciousness and ultimately the mechanisms of action of     (general) anesthetics as well as consciousness itself.   "
106733|NCT01888991|"     The purpose of this study is to investigate the effect of substrate oxidation, expressed by     RER, on food intake regulation and net energy balance.   "
106734|NCT01888978|"     Patient therapy is tailored according to the molecular profile of the patient's tumor.   "
106771|NCT01888497|"     This study will examine the next-day residual effects of a nighttime dose of gabapentin 250     mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on     simulated driving performance in normal volunteer subjects. It will also examine other     measures of next-day performance and next-day sleepiness.   "
146019|NCT01373021|"     The purpose of this study is to determine whether additional Dexmedetomidine to patient     controlled analgesia can reduce fentanyl consumption.   "
106736|NCT01888952|"     This is a Phase 0/1 open-label, non-randomized, biomarker and pharmacodynamic study in     patients with advanced B-cell lymphoid malignancies, including B-cell chronic lymphocytic     leukemia (CLL), small lymphocytic lymphoma (SLL), acute lymphocytic leukemia (ALL), multiple     myeloma (MM), Waldenström's macroglobulinemia (WM), mantle cell lymphoma, follicular     lymphoma, or diffuse large B-cell lymphoma (DLBCL) who have failed at least one prior therapy     and for whom no standard curative therapy exists. Patients with advanced stage disease are     those whose disease is resistant or refractory to standard chemotherapy or biological     therapies.   "
106737|NCT01888939|"     Background:      - Some studies in adults have found that insulin and glucose blood levels are lower when a     long period of sitting is broken up with walking, compared to sitting without breaks. This     means that the body can better process sugars when there are walking breaks during the day.     Researchers want to know if this is also true for children. Some studies have found that     children s attention and memory might be better after exercise. Researchers want to know if     short walking breaks have the same effects.      Objectives:      - To understand if breaking up sitting with walking helps children s bodies better use sugars     and improves children s concentration.      Eligibility:      - Healthy children ages 7 to 11.      Design:        -  Participants will be screened with a physical exam, medical history, exercise test,          picture vocabulary test, and medical tests including blood tests and X-rays.        -  Participants will return for two 7-hour visits. In the month before the visits, they          will wear a physical activity monitor for one week so researchers know how active they          are. Once they will take the sitting only test and once the sitting breaks test.        -  During the sitting only test, participants will sit for 3 hours.        -  During the sitting breaks test, they will sit for 3 hours with 3-minute walking breaks          every 30 minutes.        -  Both days, they will drink sugar water. Then the participants will have blood drawn from          a needle that is kept in place, and they will wear a heart monitor. They will take          attention and working memory tests on a computer and answer questions about how they          feel. They will eat a meal at the end of the test day.   "
106738|NCT01888926|"     Background:      - People with dystonia have serious muscle contractions that cause abnormal movements or     postures. This significantly affects their daily lives. The common type is called organic.     The other type is psychogenic. People with this type have typical symptoms plus some     psychological effects. Researchers will look at how rapid transcranial magnetic stimulation     (rTMS) of the brain combined with stimulation of a nerve affects the ability to detect     sensations. They will compare the responses of people with different types of dystonia. They     will also compare the responses of people with dystonia to responses of people without it.     This study may help us learn more about the nature of different types of dystonia.      Objectives:      - To see whether TMS combined with nerve stimulation affects the brain differently in people     with different types of dystonia and those without dystonia.      Eligibility:        -  Individuals at least 18 years old, who are right-handed and have dystonia.        -  Healthy volunteers at least 18 years old.      Design:        -  Participants will have two clinical visits. Each visit will be a few hours long. They          can be done on the same day.        -  Participants will be screened with a medical history and physical exam.        -  Participants will take several sensory tests. For these tests, electrodes will be placed          on their skin. The participants will feel small electric shocks during some of the          tests.        -  Participants will undergo TMS. For 2 minutes, quick electrical currents will pass          through a wire coil placed on their head. As this happens, researchers will ask the          participants to move certain muscles.   "
106739|NCT01888913|"     Background:      - We are studying people s psychological experiences and how these relate to the way people     respond have when they see information communicated in different ways. We are testing     multiple research questions in this research.      Objectives:      - To learn about how to design future research studies. Also to learn about how to best give     people information about health topics.      Eligibility:      - Women with a Body Mass Index of 25 or higher.      Design:        -  Before the study visit, participants will answer some questions online about themselves,          their experiences, and their thoughts about their weight.        -  During the study visit, participants will watch a short scene from a movie, and then          answer questions about it.        -  Participants will have a simulated doctor visit with a computerized, virtual reality          doctor. They will answer more questions about themselves, their experiences, and their          thoughts about their weight. Then they will answer questions with researchers.   "
106740|NCT01888900|"     Background:      - Some people who have chronic hepatitis C do not respond to the usual treatment with     peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may     work better for different people. The treatments will look at how specific genes interact     with the drugs. Researchers want to see how well these new drugs work in people whose chronic     hepatitis C has not responded or only partly responded to the usual treatment drugs.      Objectives:      - To compare new treatments for people with chronic hepatitis C.      Eligibility:      - Individuals at least 18 years of age who have chronic hepatitis C that has not responded to     standard treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Liver scans and a biopsy will be taken before the start of          treatment.        -  Participants will be separated into two groups. One group will have the new treatment          drugs (assunaprevir and daclatasvir). The second group will have these two drugs as well          as peginterferon and ribavirin. All participants will have an initial 4-day hospital          stay with regular blood tests to see how the start of the treatment works.        -  The first group will take the new study drug tablets daily for 24 weeks. Those who do          not respond to this treatment will also start to take peginterferon and ribavirin, and          the treatment will continue for 24 weeks after starting the additional drugs.        -  The second group will take all four drugs according to the standard dosing schedule for          24 weeks.        -  Treatment will be monitored with frequent blood tests. Liver scans, biopsies, and other          tests will be performed as directed by the study doctors.        -  Participants will have 24 weeks of regular followup visits.   "
106741|NCT01888887|"     Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin   "
106742|NCT01888874|"     -  595 patients suffering from active rheumatoid arthritis despite continued treatment with          methotrexate will be evaluated for improvement of disease activity (efficacy) when          taking GLPG0634 (3 different doses - 50mg, 100mg and 200mg daily -, each evaluated as QD          and BID regimen) or matching placebo for 24 weeks.        -  During the course of the study, patients will also be examined for any side effects that          may occur (safety and tolerability), and the amount of GLPG0634 present in the blood          (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of          action-related parameters in the blood (Pharmacodynamics) will be determined. Also, the          effects of different doses and dose regiments of GLPG0634 administration on subjects'          disability, fatigue, and quality of life will be evaluated.   "
106743|NCT01888861|"     Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing     serum and intracellular level of antioxidants and enzymes in critical ill patients, which     result in increasing ventilator dependency and length of stay in intensive care unit and it     also accelerate organ failures in patients. In this double blind clinical trial, the     investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive     care unit that the investigators expect to stay for more than 7 days in this ward and who     have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After     randomization of included patients by block randomization the investigators will give     900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control     group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency     period, length of stay in ICU, mortality and decelerate of organ failures.   "
106744|NCT01888848|"     This study is being conducted to assess the effect of dietary blueberry supplementation on     cognition and mobility in older adults. It is hypothesized that plant compounds, present in     blueberries, may improve cognition and mobility by protecting against oxidative stress and     inflammation.   "
106745|NCT01888835|"     The investigators recently conducted a double-blind, randomized controlled trial (n=60) of     limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an     FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine,     as determined by reduction in meth-positive urines. Sexual risk behaviors also declined     significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use     despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily     doses were taken. All participants received weekly substance use counseling and monthly,     brief clinician-delivered adherence counseling. The investigators propose expanding upon     these results by lengthening the treatment period to 24 weeks, with adherence reminders added     to the counseling, and determining if efficacy is sustained up to 12 weeks after drug     discontinuation. The sample size for this 9-month study is 120.   "
106746|NCT01888822|"     The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in     elective laparoscopic cholecystectomy.   "
106747|NCT01888809|"     This study will evaluate the effectiveness of providing a combination of evidence-based     behavioral health treatments for mothers who gave birth to their first child prior to the age     of 21 and who meet eligibility requirements and their children on prevention of child     maltreatment and promotion of positive socioemotional development.   "
106748|NCT01888796|"     Examination of the effect of Linagliptin versus placebo on diastolic function in patients     with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic     echocardiography.      Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be     investigated.   "
106749|NCT01888783|"     This study aims to investigate whether two different measures of tactile acuity lead to     comparable results in patients diagnosed with CRPS Type I of the upper extremity.     Additionally patients with a neuropathy of the median nerve and healthy controls are     included.   "
106750|NCT01888770|"     The purpose of this study is to investigate whether exposure to hypertensive disorders of     pregnancy and/or a preterm birth results in alterations in the cardiovascular system during     infancy.   "
106751|NCT01888757|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
106752|NCT01888744|"     The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and     for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing     hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating     hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).   "
106753|NCT01888731|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
106754|NCT01888718|"     To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30     mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing     fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U.S. LLC,     Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To monitor     adverse events and ensure the safety of subjects.   "
106755|NCT01888705|"     Recently, there has been a growing interest in the study of nonlinear dynamics as a     methodology for complementary analysis to characterize the respiratory pattern. These methods     are well established in studies of heart rate. The analyzes evaluate complex signals,     including large-scale fractal correlations and distributions in time series, and can provide     relevant clinical information.      Measures such as approximate entropy and sample entropy have shown great potential in the     evaluation of the complexity of the respiratory system, providing information relevant to the     understanding of physiological and pathophysiological processes. These measures are based on     the concept of non-linearity in the presence of a high number of interconnections, resulting     in the complex behavior exhibited by physiological systems.      The approximate entropy (ApEn) is related to the amount of clutter, complexity or     unpredictability of a data series over time. In a complementary way, the sample entropy     (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to     self-similarity.      A study conducted by our group in asthma patients with different levels of bronchial     obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in     asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in     asthma disorders that are associated with complex changes in the pathophysiology triggering     breath control, possibly resulting in changes in air flow (V´).      Considering the development silent changes of mechanical ventilation in COPD patients and     its clinical relevance, as well as the difficulty of identifying such changes through     conventional methods, we observed the need to obtain more detailed information, including the     complexity of the system breathing for better understanding of factors that contribute to the     illness.      In this context, the objectives of this study were: (1) analyze the influence of airway     obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate     the diagnostic power of the test in identifying the changes caused by COPD.   "
106756|NCT01888692|"     Acknowledging that level I evidence already exists regarding the general beneficial impact on     FDG PET in the staging and subsequent management of lung cancer the investigators postulate     that fusing PET/CT data sets with RT CT simulation data sets for adult patients with     conventionally/clinically assessed stage III non-small cell lung cancer will have a     significant impact on GTV as well as normal tissue irradiation. This research will also     estimate inter and intra-observer variability of treatment planning, relative to GTV, between     and amongst radiation oncologists.   "
106757|NCT01888679|"     The purpose of this study is to evaluate and measure the movement of the endotracheal tube     depending on the type and the amount of movement of the head of the patient intubated using a     flexible fiberoptic.   "
106758|NCT01888666|"     The aim of this study is to evaluate the periodontal effects during rapid palatal expansion     (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in     order to establish the possible differences and advantages of one of these treatments in     periodontal terms.      Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10     patients will selected and submitted to SPE treatment. The patients will treated with the     Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI;     papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during     the treatment (before, during and at the end). All measurements will performed by the same     examiner.      A descriptive statistical analysis will conducted. The paired samples Student's T test will     used to evaluate the intra-group differences between t1 and t2. The unpaired samples     Student's T test will used to evaluate between groups differences at t1 and t2. The     significance level will set at 95%.   "
106759|NCT01888653|"     Emerging research implicates biased attention to threat in the pathophysiology of anxiety     disorders. Recent findings demonstrate significant associations between attention bias and     stress vulnerability. This work has motivated the development of a novel therapy,     attention-bias-modification treatment (ABMT). ABMT is designed to implicitly modify patients'     biased threat attendance via computerized training protocols. Emerging evidence indicates     that ABMT is effective in modifying threat-related attention biases and in ameliorating     anxiety symptoms. However, it is unclear whether ABMT is efficacious for Posttraumatic stress     disorder (PTSD). The present pilot study is a double blind trial that seeks to examine     feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABMT in individuals     with PTSD. In addition this pilot study seeks to identify specific genes associated with     anxiety disorders and to examine whether these can predict the success of the ABMT.   "
106760|NCT01888640|"     Pain associated with fibromyalgia interferes with daily function, work, and social activities     resulting in a decreased quality of life. People with fibromyalgia also have a significant     amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability     of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of     the main treatments for patients with fibromyalgia must focus on pain relief to allow the     person to function more independently both at home and at work. Transcutaneous electrical     nerve stimulation is used by health professionals to deliver electrical stimulation through     the skin for pain control. Basic science studies, from the PI's laboratory show that TENS     activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus     the ideal patient population for the treatment of TENS would be one in which there is     enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.      Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve     Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related     pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC),     and that this decrease in pain and/or central excitability will reduce fatigue and fear of     movement, thereby improving function and quality of life   "
106761|NCT01888627|"     The study examine the effectiveness of an integrated care program including therapeutic     assertive community treatment (ACT) for people with psychotic disorders fulfilling severe and     persistent mental illness (SPMI, ACCESS-II study).   "
106762|NCT01888614|"     The investigators propose to evaluate etCO in patients with HbSS, HbSC, and HbS-beta     thalassemia during routine clinic visits, and longitudinally. Our goal is to know whether     etCO differs amongst subjects with different sickle cell syndrome genotypes, and whether it     is a stable marker of hemolytic rate, as reflected in routine labs obtained for clinical care     (including total hemoglobin, reticulocyte count, lactate dehydrogenase, and, when sampled,     total and direct bilirubin). We hope to establish whether this inexpensive and non-invasive     test faithfully reflects hemolytic parameters in sickle cell syndromes.   "
106763|NCT01888601|"     To study the NSCLC evolutionary genomic landscape between primary and metastatic sites and     the dynamics of intratumour heterogeneity over time combined with detailed clinical,     histopathological and cancer phenotypic annotation for each patient, in order to     significantly improve the outcomes of NSCLC patients (e.g. reduce their chance of recurrence     and improve survival).   "
106764|NCT01888588|"     The analyses are conducted in a previous population-based cohort study using The Health     Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses     are:      To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with     use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the     general population To estimate the dose-response and duration-response associated with use of     these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low     dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI)     (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the     general population To investigate the management of low dose ASA/oral antiplatelets after UPU   "
106765|NCT01888575|"     This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained     .The aims of the post hoc analyses are:      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI     concomitant use versus non-use, crude and adjusted by confounding.      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI     concomitant use stratified by age and sex.      To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA     therapy.   "
106766|NCT01888562|"     To test the patient's cancerous tumor to see if it has a FGFR mutation and, if so, to see how     their cancer responds to a treatment with the drug ponatinib as well as examine the side     effects caused by ponatinib.   "
106767|NCT01888549|"     Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux;     double-blind, placebo-controlled, randomized clinical trial   "
106768|NCT01888536|"     This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin     capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast     tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal     stenosis.   "
106769|NCT01888523|"     Determine the efficacy of a brief and inexpensive psychosocial intervention, (called     expressive writing) in improving health outcomes for cancer survivors.   "
106774|NCT01888458|"     Infections due to post transplant immune deficiency are a major problem following allogeneic     stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood     transplant (CB). Duration of neutropenia is one of the most important risk factor for     invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal     prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative,     phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as     antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few     patients in this study received a CB transplant.      This is phase IIb, prospective, open-label, non-comparative study to assess the safety of     micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB     as source of stem cells.   "
106775|NCT01888445|"     This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in     dialysis chronic kidney disease patients with anemia.   "
106776|NCT01888432|"     The purpose of this trial is to demonstrate the efficacy and safety of everolimus in     combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver     transplant recipients.   "
106777|NCT01888419|"     Background      In Denmark, breast cancer is the most common fatal cancer in women with more than 4700 new     cases annually. Unfortunately, up to 60% of women who are treated surgically for breast     cancer, will experience chronic pain as a consequence of the treatment. This state of chronic     neuropathic pain is termed Post Breast Therapy Pain Syndrome or PBTPS.      The purpose of the study      The purpose of this study is to investigate whether transplantation of fat cells     (lipotransplantation) to the pain affected mastectomy area, could have an analgesic effect in     women who have developed PBTPS. Secondary, we wish to investigate if lipotransplantation has     a beneficial effect on the quality of the skin and the scar in the area where the     transplanted fat cells are placed.      Hypotheses        -  Lipotransplantation to the area under the scar tissue and the area under the          pain-afflicted area reduces the pain in women with PBTPS.        -  The neuropathic pain in PBTPS is correlated to the number of free nerve endings crossing          the border between the dermis and the epidermis        -  Lipotransplantation have a beneficial effect on the scar tissue structure and improves          the skin quality.      Patients      Women who have undergone treatment for breast cancer and subsequently developed PBTPS. A     total of 32 patients with PBTPS will be included.      Methods      Patients will be randomly assigned to receive either lipotransplantation or no active     treatment. At three follow-up visits, the perceived pain of the patient and the skin and scar     quality will be scored. In addition, a 3-mm biopsy will be taken from the skin on both the     missing and the healthy breast, and from the mastectomy scar.      The scoring of the perceived pain and the quality of the skin and the scar, allows us to     investigate if the lipotransplantation have an effect on pain, and skin/scar quality.     Additionally, the skin and scar biopsies will be examined on a microscopic level, in order to     investigate why lipotransplantation has these effects.      Conclusion      In summary, the results of this project could help to increase our understanding of why some     patients develop chronic neuropathic pain after mastectomy and radiotherapy. It is our hope     that our results may contribute to the development of better and more effective treatment     that will be beneficial for the project participants and future patients.   "
106778|NCT01888406|"     BEST4US compares the effectiveness of two forms of self-help interventions that target     college students, ages 18 years to 22 years, who report binge eating. The overall question is     whether one or the other format will prevent excess weight gain and lead to differences in     eating behaviors. The two formats are (1) pure self-help (receipt of a self-help program     via book form or online texts) and (2) a combination of the self-help program and guidance     provided by a trained peer coach over the course of 8 weekly sessions.   "
106779|NCT01888393|"     This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of     lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.   "
106780|NCT01888380|"     In light of declining autopsy rates around the world, post-mortem MR imaging is a promising     alternative to conventional autopsy in the investigation of infant death. A major drawback of     this non-invasive autopsy approach is the fact that histopathological and microbiological     examination of the tissue is not possible. The objective of this prospective study is to     compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy,     with conventional autopsy procedures in a paediatric population.      Foetuses, newborns, infants and children that are referred for autopsy at three different     institutions associated with the University of Zurich will be eligible for recruitment. All     bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators     will be blinded to the results of conventional autopsy. After cross-sectional imaging,     CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot)     allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with     regards to the likely final diagnosis and major pathological findings and compared to the     results of conventional autopsy, which remains the diagnostic gold standard.      This interdisciplinary study will determine whether virtual autopsy will narrow the gap in     information between non-invasive and traditional autopsy procedures.   "
106781|NCT01888367|"     This is a randomized, blinded, placebo and standard of care controlled study of the efficacy     of a novel antibiotic containing gel compared to placebo gel in preventing surgical site     infection after abdominal surgery. patients will be randomized to active or placebo gel in a     double-blind manner. The gel will be applied a single time in the incision during closure at     the end of surgery. A cohort of patients will also be randomized to standard of care, saline     irrigation at prior to skin closure, in an open manner. The efficacy, safety and tolerability     of the active gel will be assessed compared to the control group (combined placebo gel and     standard of care groups). Patients will be randomized to DFA-02 active gel: placebo gel:     standard of care in a 4:1:1 ratio.   "
106782|NCT01888354|"     This pilot study is designed as a prospective cohort study to determine whether standard     subcutaneous (SQ) Highly-Purified (HP) Acthar Gel 14 days is superior to SQ HP Acthar Gel 5     days in the treatment of relapses or attacks in multiple sclerosis (MS).   "
106783|NCT01888341|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     isotretinoin formulations after administration of single doses to normal, non-smoking,healthy     males under fasting conditions   "
106784|NCT01888328|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     isotretinoin formulations after administration of single doses to normal, non-smoking,healthy     males under fed conditions   "
106785|NCT01888315|"     The study is aiming to document the long-term safety and effectiveness of renal denervation     in patients with hypertension and other diseases characterized by elevated sympathetic drive.     Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.   "
106808|NCT01888016|"     The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to     reduce pain and improve physical functionality after rotator's cuff surgery. The technique     involves deep friction manipulation of fascia's specific spots. Distant from surgical site.   "
113141|NCT01805011|"     This trial is undertaken to better understand the ranges of functional components normally     found in human milk. This will strengthen the scientific knowledge on breast-milk composition     as a gold standard.   "
106786|NCT01888302|"     This pilot phase I trial studies the side effects and best way to give sirolimus, gemcitabine     hydrochloride, and cisplatin in treating patients at high risk for cholangiocarcinoma     recurrence after liver transplant or surgery. Sirolimus may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving sirolimus with     gemcitabine hydrochloride and cisplatin may prevent disease recurrence in patients with a     high risk of recurrence after a liver transplant or surgery.   "
106787|NCT01888289|"     The purpose of this study is to determine the pharmacokinetics and bioequivalence of     isotretinoin formulations after administration of single doses to normal, non-smoking,healthy     males under fasting conditions   "
106788|NCT01888276|"     The pathophysiology of compulsive disorders as gambling could be close to behavior problems     encountered in Parkinson's disease associated with a hyperactivity of the motivational     system.      Thanks to the words generation test, which reflects the cortico-subcortical loop functioning,     involved in motivation, we want to evaluate and compare using tools (words generation and     behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can     then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic     disorders which were explored in another study.   "
106789|NCT01888263|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
106790|NCT01888250|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
106791|NCT01888237|"     The purpose of this study is to compare the efficacy between 1-day high dose PPI-based triple     therapy vs. 10-day sequential therapy for Helicobacter pylori eradication in functional     dyspepsia patients.   "
106792|NCT01888224|"     To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin     Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin)     Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male     subjects under fed condition.   "
106793|NCT01888211|"     The mechanisms through which omega-3 fatty acids reduce adverse cardiac events remain     uncertain. The aim of the study was to investigate the effect of omega-3 fatty acid     supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and     monocyte activation in patients with coronary heart disease.   "
106794|NCT01888198|"     The purpose of this study is to better understand how effective ablation is for destroying     tumor cells in the kidney and whether quality of life is improved for patients. Participation     in ARMOR may involve retrospective data collection only, combined retrospective and     prospective data collection, or prospective data collection   "
106795|NCT01888185|"     This study is designed to determine if magnetic resonance imaging (MRI) measures can be used     to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing     between PD and parkinsonisms [conditions that are PD look-a-like diseases such as progressive     supranuclear palsy (PSP) or multiple system atrophy (MSA)] when combined with changes in     certain proteins in body fluids that are related to iron (Fe).   "
106796|NCT01888172|"     The purpose of this study is to conduct a randomized controlled trial to compare the weight     losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips     ActiveLink physical activity system, over a 1-year period, compared to a control group.   "
106797|NCT01888159|"     Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation     has an effect on ovarian reserve.   "
106798|NCT01888146|"     The overall aim of this study is to adopt an integrative rehabilitation approach for helping     patients adopt self-management skills for managing chronic pain, limiting use of opioid     medications, and identifying exacerbating factors amenable to treatment (e.g., depression,     sleep problems) that is feasible and sustainable within the primary care setting.   "
106799|NCT01888133|"     Can participation in group physical activity, such as a community-based organized group walk,     help adult diabetes patients develop a physically active lifestyle? Can such engagement     ultimately lead to an improvement in hemoglobin A1c? To address this question, the     investigators have designed this pilot study with the aim to investigate the effect of     community-based group walks among Joslin adults with diabetes on the development of a     physically active lifestyle and glycemic level. The investigators hypothesize that     participation in group walking events helps Joslin adults with diabetes engage in physical     activity and improves glycemic control.   "
106800|NCT01888120|"     The objectives of this study are to evaluate the effectiveness, long-term safety,     tolerability, satisfaction with treatment, and health-related quality of life (HRQoL)     associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.   "
106801|NCT01888107|"     The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety     of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric     disorder with symptoms of emotional instability, detachment from reality, often with     delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed     psychiatric disorder relating to a complex psychotic state that has features of both     schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving     treatment with any antipsychotic medication and who required a long-term antipsychotic     therapy. The secondary aim is to investigate prospectively (a study that starts with the     present condition of a population of individuals and follows them into the future) the     prevalence of patients who met standardized remission criteria (according to Andreasen et al.     criteria) and the psychopathological, psychosocial and subjective predictors of achieving     remission.   "
106802|NCT01888094|"     Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the     subclavian venous and examination guided with ultrasound   "
106803|NCT01888081|"     The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing     irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable     with median overall survival periods that range from 8-16 months.   "
135813|NCT01507064|"     The purpose of this study is to determine whether neoadiuvant therapy with sorafenib     increases the efficacy of thermal ablation in inducing the necrosis of hepatocellular     carcinoma.   "
106809|NCT01888003|"     The goal of this study is to gain further insight into the comparative effectiveness of     treating patients, who are found to be anemic before their elective surgery, with a series of     weekly subcutaneous doses of a drug given before surgery, which stimulates the natural     production of red blood cells (a so-called erythropoietic stimulating agent [ESA]) along with     intravenous iron, in reducing the need for blood transfusions (donated by someone other than     the patient) during and after adult total hip arthroplasty (hip replacement surgery). The     effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of     recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery     will also be examined. A cost-effectiveness analysis will be performed to compare the cost of     these commercially available, FDA-approved medications versus the cost of transfused blood   "
106810|NCT01887990|"     This study is dedicated to achieving better treatments for suicidal thoughts. Specifically,     the investigators are studying the effect of a medication called ketamine to quickly treat     suicidal thoughts and depression.   "
106811|NCT01887977|"     A computational model of human sound production based on high quality anatomic measurements     and physical laws of sound propagation cannot be accomplished without a comprehensive data     set including both 3D-images of the speaker's anatomy and the simultaneous recording of     speech. Since the computational model has separate models for the vocal folds and the vocal     tract, patients undergoing an orthognathic surgery is an optimal test object for the model     development. Vocal folds remain unchanged while substantial changes take place in the vocal     tract. Moreover, since the aim of the research is to predict acoustic changes in speech due     to operations in head neck area, the orthognathic patient group is par excellence an example     of such a prediction problem. If the model can be shown to give valuable information     pre-operationally, many other patient groups could benefit from the results.   "
106812|NCT01887964|"     Metabolic syndrome is a condition characterized by excess body weight, large waist     circumference, high cholesterol and glucose in the blood, and hypertension. People with     metabolic syndrome are at increased risk for heart diseases. Research shows benefits of     regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the     high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients.     This study is designed to find if blinded-substitution of regular wheat flour in domestic     kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4),     minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from     wheat.   "
106813|NCT01887951|"     Introduction      Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia     delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties     administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It     is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a     potential agent for early administration of analgesia by Singapore Civil Defense Force (SCDF)     EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use     as an analgesic agent in general are limited and there are few published controlled trials of     methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used     in the hospital setting for analgesia. It is well proven, simple to deliver and is not a     controlled drug.      Aim      To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by     the SCDF EAS.      Methodology      The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol).     Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility     criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances), will     be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other     half (15 ambulances), will be trained and equipped with tramadol. Allocation will be on a per     station level. After 6 months, they will cross over to Penthrox and tramadol respectively.      All paramedics will be trained to use both medications, pain scales and Ramsey scores, and     will record patient's pain, sedation scores and patient satisfaction as part of routine     clinical practice. All patients will be followed up by a review of their Emergency Department     and hospital records for any medication related adverse effects.      Hypothesis      The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting to     the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by inhaled     methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue Scale (VAS)     at 5, 10, 15 and 20 min after start of the study treatments.   "
106814|NCT01887938|"     The purpose of this study is to collect long-term safety data in patients with metachromatic     leukodystrophy (MLD) who are receiving HGT-1110 and have participated in Study HGT-MLD-070     through Week 40.   "
106815|NCT01887925|"     The purpose of this study is the evaluation of effect of circadian gene on sleep and other     symptoms in breast cancer patients under chemotherapy.   "
106816|NCT01887912|"     The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile     vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a risk for     CDI where there is a substantial unmet medical need.      Primary objective:        -  To assess the efficacy of the C. difficile vaccine in preventing the onset of          symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult subjects          aged ≥ 50 years who are at risk for CDI and have received at least 1 injection.      Secondary Objectives:      Efficacy:        -  To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections          administered at 0, 7, and 30 days        -  To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of          at least 2 injections.      Immunogenicity:        -  To describe the immunogenicity to toxin A and toxin B in the subset of subjects at          specific time points.      Safety:        -  To describe the safety profile of all subjects who receive at least 1 injection.   "
106817|NCT01887899|"     The aim of this study is to investigate whether the anodal transcranial direct current     stimulation (tDCS) over the primary motor cortex (M1) in patients with dementia of the     Alzheimer type (DAT) leads to an increase in cortical plasticity (change in motor evoked     potentials (MEP) in mV).   "
106818|NCT01887886|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety     and efficacy of onartuzumab in combination with erlotinib in patients with previously     untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and     activating EGFR mutation and MET-positive. Patients will be randomized to receive either     onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally     daily or placebo in combination with erlotinib. Anticipated time on study treatment is until     disease progression or unacceptable toxicity occurs.   "
106843|NCT01887561|"     The purpose of this study is to assess whether dasatinib can be discontinued without     occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in     complete molecular remission(CMR) while on dasatinib.   "
107379|NCT01880567|"     The goal of this clinical research study is to learn if a combination of ibrutinib and     rituximab can help control MCL in patients with relapsed or refractory disease or in patients     over 65 who have newly diagnosed MCL. The safety of this drug combination will also be     studied.   "
106819|NCT01887873|"     The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients     with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating     deep sclerectomy procedure.      In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of     cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open     angle glaucoma and clinically significant cataract. Given that a considerable number of     glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer i.o.     during a combined procedure of phacoemulsification and deep sclerectomy. This is also of     importance because a combined procedure avoids the need of a second operation in this group     of patients. Finally, it has been shown that combined phacoemulsification - deep sclerectomy     does not induce a further risk compared to deep sclerectomy alone(open phase I study).      Safety will be assessed based on the occurrence of adverse events.      Efficacy assessments will be performed at every visit and efficacy analysis will include:        -  Proportion of subjects at each study time point which will need additional IOP lowering          drug therapy to achieve an IOP reduction to values < 21 mmHg. If a subject needs more          than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP          reduction will be recorded.        -  Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture to          achieve an IOP reduction to values < 21 mmHg.   "
106820|NCT01887860|"     Determine if Cetaphil Daily Facial Moisturizer SPF 50 proves to be a contact sensitizer or     irritant in certain individuals.   "
106821|NCT01887847|"     The objective of this study is to compare the pharmacokinetics of an investigational 2 mg     sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine     lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise     healthy smokers.   "
106822|NCT01887834|"     The Canadian College of Naturopathic Medicine is conducting a research study on Irritable     Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring     gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is     characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and     bloating.      The medicines that are currently used to help people with IBS are not as effective as we     would like them to be. These medicines are usually only prescribed to reduce the pain of IBS     and not actually treat the disorder itself. Recently, scientists have found that probiotics     (beneficial bacteria that live inside humans) may help reduce the painful symptoms and     diarrhea that are part of IBS.      This research is being conducted to determine whether this particular combination of three     probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium     longum) will reduce the symptoms of severe IBS.   "
106823|NCT01887821|"     This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the     two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for     treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for     many years they become less effective at treating a disease, especially when they are not     used at adequate doses according to national guidelines or when counterfeit drugs are     available in the market. The purpose of this study is to check that Chloroquine and     Artemisinin, are still effective for patients in Viet Nam.      Participants in this study will be treated with either Dihydroartemisinin-Piperaquine     (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national     guidelines to treat vivax malaria. The investigators would like to know if both of these     treatments are equally effective so half of the patients in the study will be treated with     DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare     the drugs to find out if one is better than the other.      Participants will be followed for 3 days in hospital, then regularly by follow-up visits     until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites     in the participant's body and how the blood cells react to the malaria. The parasite will be     tested to determine what type it is and how it reacts to the treatment.      The results of the study will be used to inform malaria treatment guidelines in Viet Nam.   "
106824|NCT01887808|"     Determine if Cetaphil DermaControl Oil Control Moisturizer SPF 30 proves to be a contact     sensitizer or irritant in certain individuals   "
106825|NCT01887795|"     1. Verify the effect of Erlotinib concurrent whole-brain radiation therapy as ﬁrst-line          treatment for patients with multiple brain metastases from non-small-cell lung cancer to          compare with WBRT alone.        2. Verify pre-built EGFR mutation prediction model for NSCLC brain metastases   "
106826|NCT01887782|"     This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the     standard conventional high frequency left sided stimulation protocol. The Left dorsolateral     prefrontal cortex will be the site of stimulation in both treatment conditions. The site of     stimulation will be targeted using MRI co-registration. The study seeks to determine if the     two treatment protocols have similar effectiveness in treating major depression.   "
106827|NCT01887769|"     Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer     is the leading cancer-related death worldwide and it represents a pressing health issue.     Patients with lung cancer are more likely to experience cachexia, a severe debilitating     disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical     function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in     about 80% of advanced cancer patients is the direct cause of death in about 20% of cases.     However, despite the importance of cachexia in lung cancer, it has been mainly studied from     several assessment methods which do not usually differentiate muscle from other tissues.      Aim: To analyze body composition of patients with lung cancer at diagnosis using computed     tomography (CT-Scan) image analysis.      Methods: This is a retrospective study extending over a period of 3 years conducted at the     Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed     patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in     our institution. Following the collection of clinical data from patient records, we used     SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area     from a single abdominal cross-sectional image at the level of the third lumbar vertebra.   "
106859|NCT01887353|"     The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of     recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved     ejection fraction.   "
106828|NCT01887756|"     Telerehabilitation refers to the use of Information and Communication Technologies (ICT) to     provide rehabilitation services to people remotely in their homes or other environments. By     using ICT, patient access to care can be improved and the reach of clinicians can extend     beyond the physical walls of a traditional healthcare facility, thus expanding continuity of     care to persons with disabling conditions. The concept of telecare, when telerehabilitation     is used to deliver services to patients in their homes or other living environments, empowers     and enables individuals to take control of the management of their medical needs and     interventions by enabling personalized care, choice and personal control Research Goal and     Objectives        1. To investigate the clinical feasibility and usability of the Gertner Tele-Motion-Rehab          system in post-stroke patients, in their homes.        2. To evaluate Gertner Tele-Motion-Rehab system clinical improvement within the patient's          home in terms of:             1. function of the weak upper extremity             2. performance of ADL   "
106829|NCT01887743|"     The World Health Organization has declared childhood obesity to be one of the most serious     public health challenges of the 21st century,     (http://www.who.int/dietphysicalactivity/childhood). Given that obese children are generally     excluded from clinical trials, little to no information exists regarding the impact of     obesity on drug disposition and drug action, creating a gap in physicians' knowledge on how     to appropriately select the dose of many critical medications (e.g., anticancer agents), so     as to prevent toxicity associated with overdosing, while avoiding the harms of     under-treatment. The proposed study will examine the effect of obesity on the metabolism of a     commonly used medication, the proton pump inhibitor pantoprazole, by exploring the     relationships between age, obesity, basal metabolic rate and genetic control of the enzyme     primarily responsible for pantoprazole metabolism. We will also validate a simple breath test     that can be used to predict pantoprazole dose requirement for obese children.      The study is designed to test the following experimental hypotheses:[13C]-pantoprazole     pharmacokinetic parameters are not different between non-obese and obese children and     adolescents, collectively (both age groups combined) or stratified by age group (SA 1)     [13C]-pantoprazole pharmacokinetic parameters or DOB values (and thus, CYP2C19 activity) are     not different between males and females (SA 1 & 2) [13C]-pantoprazole pharmacokinetic     parameters and DOB (Delta over baseline) values (and thus, CYP2C19 activity) are independent     of age over the age range of 6 to 17 years (SA 1 & 2) Obesity does not alter the relative     contributions of CYP2C19-dependent and non-CYP2C19-dependent (i.e., CYP3A4) metabolism of     pantoprazole, as measured by the urinary ratio of 4-hydroxy-pantoprazole to pantoprazole     sulfone (SA 1 & 2) The [13C]-pantoprazole breath test, by determining DOB at discrete time     point(s), is a non-invasive measure of CYP2C19 phenotype (SA 2) Clearance of pantoprazole     (surrogate for CYP2C19 activity) is a function of REE in obese and non-obese children and     adolescents (SA 3) Pantoprazole clearance (surrogate for CYP2C19 activity) is associated with     fat distribution, as determined by waist-to-hip ratios (SA 3)   "
106830|NCT01887730|"     In this study the investigators aim to elucidate the possibility to reduce occurrence of     infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators     will study occurrence and transmission of infections. In addition, the investigators will     find out the causative agents of infections in a garrison with virological analyses of     naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to     infectious diseases will be evaluated with a cost analysis study.   "
106831|NCT01887717|"     This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled     clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care     therapy (sorafenib) in the treatment of patients with inoperable liver cancer and blockage of     the portal vein.   "
106832|NCT01887704|"     The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective,     randomized controlled trial was perform to explore the immediate effect and long-term outcome     of rotational atherectomy in patients with balloon resistant coronary lesion.   "
106833|NCT01887691|"     The purpose of this study is to examine the influence of sleep effectiveness on glucose and     insulin metabolism in health and disease (prediabetes and type two diabetes).      We will monitor sleep effectiveness using the sleep spectrogram, obtain serial nocturnal     blood glucose and insulin measurements, and assess the impact of pharmacologic enhancement     [using eszopiclon (Lunesta), a medication that promotes stable sleep)] on glucose and insulin     homeostasis.      We hypothesize that 1: Effective sleep is associated with enhanced insulin sensitivity,     relative to ineffective sleep states, and 2: Enhancing sleep effectiveness using eszopiclone     (Lunesta) improves 24-hour glucose metabolism in prediabetics and diabetics compared to     baseline.   "
106834|NCT01887678|"     The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® /     Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated     with osteoarthritis of the knee.   "
106835|NCT01887665|"     The clinical trial portion of this study tests the hypothesis that contingency     management-based incentives for primary care patients with substance use disorders to attend     treatment services will increase treatment initiation and engagement. The investigators are     investigating whether this approach that has been found effective in specialty treatment     settings will work in the primary care context, in conjunction with screening.   "
106836|NCT01887652|"     The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to     identify women at risk of excessive and poor response in controlled ovarian stimulation (COS)     for in vitro fertilization (IVF), and the clinical impact of applying individualized COS     strategies in these subsets of patients.   "
106837|NCT01887639|"     A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain     local data about the prevalence of non remitted depressed patients after an antidepressant     treatment, and to get information about sociodemographic and clinical characteristics of     these patients as well as features of their treatments and compare them with those of the     patients that achieve remission. Also the effect of patient´s expectation in the treatment     outcome will be examined.   "
106838|NCT01887626|"     Study to investigate if the uptake of Ticagrelor into the body differs depending on method of     administration.   "
106839|NCT01887613|"     This study is to investigate the long-term safety and efficacy and the information on the     proper use of Regnite® under conditions of daily clinical use.   "
106840|NCT01887600|"     This study is conducted to treat anemia in patients with chronic kidney disease. Anemia is a     reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of     oxygen in your blood. The purpose of the study is to see if Roxadustat is both effective and     safe as a treatment for anemia in patients with chronic kidney disease.   "
106841|NCT01887587|"     This is a phase I study of vincristine, doxorubicin and dexamethasone (modified VXD) plus     MLN9708 in adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma,     lymphoblastic lymphoma or mixed phenotype acute leukemia.   "
106842|NCT01887574|"     Collect valuable risk factor and quality of life data from Renal Cell Carcinoma patients and     harness the latest technology to organize and analyze data.   "
106844|NCT01887548|"     Quality of life is recommended as one of essential parameters to evaluate treatment effect     and clinical outcome in patients with Crohn's disease (CD). Recent studies reported that     several disease-unrelated variables may affect quality of life in CD patients. This study is     dedicated to investigate the influence of various personality traits on quality of life, and     whether or not they should be taken into account when evaluating clinical outcomes in     patients with CD.   "
106845|NCT01887535|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of multiple-ascending dose JNJ-54861911 which is currently being developed     for the treatment of Alzheimer's disease.   "
106846|NCT01887522|"     Multicenter, open label, prospective study including successively a phase I trial and then a     phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both     drugs, vinblastine and nilotinib.   "
106847|NCT01887509|"     This innovative study will involve the use of probe-based confocal laser endomicroscopy, a     new medical imaging technology never used for surgical indications to date. Virtual biopsies     (pCLE images) will be compared to histopathology analysis.      This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE     will allow identification of rectal tumor margin, comparable to that of histopathology. In     the future, decision of resection margin could rely on intraoperative pCLE exam.      The proposed study is a feasibility study, first in the indication of rectal cancer.   "
106848|NCT01887496|"     Epidemiological information on varicella complications in children is essential for the     development of appropriate immunization recommendations. Economic analyses of varicella     immunization are sensitive to the costs of hospitalized cases, so there is a need to validate     varicella-related hospitalization data in a country-specific manner. These data also provide     a baseline for comparison with data collected after routine varicella immunization to     evaluate the overall impact and cost-effectiveness of varicella immunization programs.     Knowledge about the cause and incidence of varicella-related hospitalizations in Turkey is     limited, center-specific and not sufficiently accurate. The aim of this multicenter study     (VARICOMP) was to estimate the annual incidence of pediatric varicella-related     hospitalization, describe the associated complications and estimate the annual mortality and     economic cost of these cases.   "
106849|NCT01887483|"     A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus     on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).   "
106850|NCT01887470|"     The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a     preparation for colonoscopy.   "
106851|NCT01887457|"     This is a trial to determine whether giving a patient a tailored dose of voriconazole is safe     and effective.   "
106852|NCT01887444|"     The purpose of this study is to evaluate the efficacy of the oral administration of     Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty     breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to     receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time     >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups.     The average daily crying time as well as the associated digestive symptoms will also be     analyzed.   "
106853|NCT01887431|"     The purpose of this study is to determine whether Telecare can be used for efficient     management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent     clinic visits.   "
106854|NCT01887418|"     Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.   "
106855|NCT01887405|"     The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for     the proportion of subjects with a successful self-injection. And to evaluate and compare the     handling characteristics of two auto-injectors (Jext and EpiPen).   "
106856|NCT01887392|"     The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice     guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the     gap between knowledge generated from research and practice. The investigators' primary     objective is to evaluate if this intervention can increase the percent of long-term care     (LTC) residents receiving appropriate treatment for osteoporosis (i.e. treatment is     considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis     or a fragility fracture of the hip or vertebrae and those who have had more than one     fragility fracture and is therefore considered high-risk). A secondary objective is to     examine whether the intervention increases the percent of all LTC residents receiving Vitamin     D equivalent to ≥800 IU/day.   "
106857|NCT01887379|"     Furosemide is a diuretic drug, used in the treatment of oedematous states associated with     cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to     thiazide diuretics. Furosemide is also used in the treatment of hypertension.      Absorption of furosemide from the gastrointestinal tract is fairly rapid; bioavailability is     60-70%, but variable and not predictable, with large intra- and inter-individual variability,     and are influenced by dosage form, underlying diseases, and by the presence of food after     oral administration. Data from animal model show that furosemide administered into the     stomach is more rapidly absorbed than if is administered into the small intestine.      To increase the residency of furosemide in the stomach after oral administration, a     gastroretentive dosage form (GRDF) of furosemide has been developed. In the current study,     the new formulation (30mg furosemide coated tablet) will be tested in healthy male subjects.     Absorption will be characterised by an effective and safe imaging technique - Magnetic Marker     Monitoring (MMM), based on Fe3O4 added to the drug product to generate magnetic signal that     can be used for up to 12 h after furosemide administration to localize the medication in the     gastrointestinal tract. Fe3O4 is frequently used as colouring pigment in medicinal products.     It does not exhibit own pharmacodynamic activity and is considered as an inactive ingredient.      In the current study, GRDF formulation of furosemide will be evaluated for: gastric residence     as well as pharmacokinetic and pharmacodynamic characteristics under fasting and fed     conditions. As part of the study, the subjects will be hospitalized for 1 day during each     drug administration. The duration of the stay will depend on the intestinal behaviour of the     investigational product.   "
106858|NCT01887366|"     The primary objective of this study is to assess the efficacy and safety of TV-1380     [Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)] in     facilitating abstinence in cocaine-dependent subjects.   "
106861|NCT01887327|"     Neonatal jaundice is the most common cause of hospital readmission for term- and near term     infants and its management poses a significant burden on the healthcare system.      Infants with isoimmune hemolytic disease, such as ABO or Rhesus (Rh) incompatibility, or     glucose-6-phosphate dehydrogenase (G6PD deficiency), have an increased rate of red cell     destruction and, thus, an increase in bilirubin production. Newborn infants have immature     liver function and do not conjugate bilirubin well, which results in accumulation of     unconjugated bilirubin. Thus, bilirubin levels may rise rapidly and intervention may be     required. At present, phototherapy (PT) is the most frequently used treatment for     hyperbilirubinemia; it converts unconjugated bilirubin to less toxic water soluble     photoisomers that are then excreted in the urine without need for conjugation. Infants who do     not respond to PT are treated by exchange transfusion (ET), considered a therapy of last     resort because of associated morbidity and mortality. Both PT and ET enhance the elimination     of, but have no impact on the production of bilirubin.      Stannsoporfin is a heme oxygenase inhibitor that acts to reduce bilirubin production. It is     being developed for the management of neonatal jaundice.   "
106862|NCT01887314|"     The purpose of the study is verify the capability of a standardized Ginger (Zingiber     officinale) extract to manage nausea in cancer patients receiving highly emetogenic     treatments and standard anti-emetogenic therapy.   "
106863|NCT01887301|"     A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug),     safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol     [THC] and 10 mg cannabidiol [CBD]) in healthy patients and those with hepatic (liver)     function impairment.   "
106864|NCT01887288|"     To evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine     with oral digoxin in metastatic breast cancer   "
106865|NCT01887275|"     The purpose of this study is to investigate the efficacy and safety of medical ozone in     treatment of chronic hepatitis B patients.   "
106866|NCT01887262|"     Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better     protection of residual renal function over 1 year period, compared with management guided by     clinical information alone - such as blood pressure, body weight, and physician's physical     examination.   "
106867|NCT01887249|"     10-day sequential therapy was not sufficient to overcome tough situation for H. pylori     eradication in Korea due to high antimicrobial resistance. The present investigators assumed     that doubling duration of second phase of sequential therapy might have more potent     bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with     initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with     metronidazole was not ever tested before. Moreover, whether extending the sequential therapy     to 15-day might be more effective than 10-day sequential therapy is unknown especially in     Korea. From this background, the present investigators prepared clinical trials regarding     modified sequential therapy which was extending the treatment duration to 15 days compared     than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial     susceptibility testing was performed to find the possibility to overcome antimicrobial     resistance.   "
106868|NCT01887236|"     Individuals of advanced age undergo both physical and cognitive deterioration. The aim of     this study is to explore the effect of two types of physical activity on stability     parameters.   "
106869|NCT01887223|"     When the glaucoma filtering surgery failures (intraocular pressure rises again), the options     is start to use the hypotensive eye drops again (medical treatment). However, in some cases     (encapsulated blebs), there is a simple surgical revision that can revival the primary     failure surgery. It calls transconjunctival needling revision. In this study, the     investigators compare the efficacy of this revision versus medical treatment in 12-month     follow up in eyes with encapsulated blebs.   "
106870|NCT01887210|"     This study will develop and test a novel, technology based intervention to improve treatment     adherence among youth living with HIV who are taking antiretroviral medication. In the     intervention youth will access an engaging and immersive app/game on their smartphone.Data     about the opening of the smart pill bottle will be transferred from the bottle cap wirelessly     and will trigger a text message about their adherence. While gaming, participants will gain     information about their health, improve motivation for ARV and medical appointment adherence,     and practice healthy behaviors. If the Intervention is found to be effective, it can be     tested in a larger study and then disseminated to other youth on antiretroviral medications.   "
106871|NCT01887197|"     The investigators are developing a new nuclear medicine imaging technique for measuring     liquid absorption in the airways that can be applied to screen new medications being     developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the     small molecule radiopharmaceutical Indium 111 diethylene triamine pentaacetic acid (In-DTPA)     will indicate changes in liquid absorption in the airways and demonstrate whether new CF     medications will be effective. In this study the investigators will determine whether the     imaging technique will demonstrate similar results when it is repeated on different days.     They will also determine how their results change when subjects utilize several common CF     medications.   "
106898|NCT01886846|"     We aimed to investigate if adiponectin facilitates diagnosis of ARF by analyzing adiponectin     levels in acute and convalescent periods of the acute rheumatic fever and by comparing     results with that of healthy control group; also by comparatively examining levels of     adiponectin in ARF cases who had different clinical findings at presentation. In addition, we     aimed to investigate its role in the pathogenesis of ARF by evaluating correlations with     cytokines such as TNF-α, IL-6 and IL-8 and acute phase reactants.   "
106913|NCT01886651|"     The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT)     activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment     interruptions during maintenance therapy for children with ALL.      Hypothesis of the study: Patients with TPMT activity compatible with TPMT low activity     polymorphisms have an increased risk of toxicity following high-dose methotrexate (HDM)     compared to children with normal TPMT activity.   "
107116|NCT01884012|"     In this randomized-controlled, cross-over trial the investigators test the effect of     long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases     of 2 weeks on exercise performance and quality of life and many physiological parameters in     patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.   "
106872|NCT01887184|"     Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may     be associated with discomfort. Although upper endoscopy is usually of shorter duration and     better tolerated by patients, most trials investigating the influence of analgesia and     sedation have been performed on patients undergoing this procedure. Some patients may     tolerate colonoscopy without sedation, but various techniques are used to limit discomfort     and pain. Selection and dosing of sedatives depends on the patient's emotional state, the     intensity of pain during examination, foreseeable technical difficulties, the endoscopist's     experience, the presence or absence of anesthesia personnel, and hospital-specific     procedures.      Conscious sedation is a popular technique for colonoscopy and upper gastrointestinal     endoscopy. The combination of an opioid and a benzodiazepine is known to provide good     analgesic and sedative conditions during endoscopy. This combination of opioid and     benzodiazepine, however, also increases the risk of respiratory depression. Therefore,     pharmacologic agents which may provide adequate sedation without respiratory depression are     of great interest to clinicians.      Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative and analgesic     effects. Compared with clonidine, it is more selective for the α 2 adrenoceptor and acts as a     full agonist in most pharmacologic test models. Potentially desirable properties include     decreased requirements for other anesthetics and analgesics, a diminished sympathetic     response to stress and the potential for cardioprotective effects against myocardial     ischemia. When compared with conventional sedatives such as opioids or benzodiazepines, its     lack of respiration depression is a distinct advantage. Previous studies using     dexmedetomidine for sedation has been promising with maintenance of respiratory function.     Patients are readily arousable. With intravenous slow bolus administration, there is a     minimal increase in blood pressure initially, followed by a slight decrease in blood     pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of     administration tend to decrease these circulatory side effects. Many clinical studies have     shown that it can be well and safely used intravenously, intramuscularly and transdermally.     Although not an officially technique, there are also reports of intranasal administration     resulting in fairly predictable onset in both adults and children.   "
106873|NCT01887171|"     The purpose of this study is to determine whether the Tacrolimus added to     histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and intraarterial     infusion during back-table procedure is capable of reducing the degree of early allograft     liver dysfunction, as assessed by postoperative levels of aspartate aminotransferase (AST),     alanine aminotransferase (ALT), during first 7 postoperative days and by serum and     histochemical markers of liver injury and inflammation.   "
106874|NCT01887158|"     Studies that have investigated different bowel preparations in patients with history of     colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in     this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the     most popular and safest bowel preparation regimens, however the 4-Liter volume is often     poorly tolerated. More recently, it has been shown that the use of a low volume preparation     (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel     cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the     efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.   "
106875|NCT01887145|"     No randomized trials have compared long-term outcomes following endoscopic and open carpal     tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a     single-center randomized controlled trial between January 1998 and December 2002, including     128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed     idiopathic CTS. The outcome measures included the validated CTS symptom severity and     functional status scales completed at baseline and 1 year postoperatively. The trial showed     that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and     function were equivalent. This extended follow-up of the randomized trial will primarily     measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by     mail to the patients. The questionnaire will consist of the CTS symptom severity and     functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of     the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog     scale about treatment satisfaction. The patients will also be asked about whether they had     undergone further surgery for CTS in the same or contralateral hand after their operation in     the randomized trial. The completed questionnaires will be scanned into a database. The     scores for the different scales will be calculated. Analysis will include comparison between     the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15     years.   "
106876|NCT01887132|"     Background:      - Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some of     these children spend very little time in the rapid eye movement (REM) stage of sleep. Some     studies suggest that less time in REM sleep can be associated with learning and behavior     problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil can increase     REM sleep in some adults with different disorders. A small study showed that Donepezil can     also increase REM sleep in children with ASD. Researchers now want to see if Donepezil can     improve communication skills and social interaction in children with ASD. They also want to     see if any change in symptoms seems to come from changes in REM sleep.      Objectives:      - To see if a medication, Donepezil, can improve the way communication skills and social     interaction develop in young children with autism spectrum disorders.      Eligibility:      - Children 22 to 44 months of age with ASD.      Design:        -  Participants will be screened with a blood test, heart tests, and a sleep study. During          the sleep study, children will sleep in a darkened room for 2 nights with electrodes on          their body and a tube under their nose. Parents can sleep in the room with their child.          A technician will monitor the room all night.        -  Participants will take the study medication once a day.        -  Treatment will be monitored at visits every 3 months. At each visit the participant will          take blood tests, heart tests, or behavior tests. Participants will have 2 more sleep          studies.        -  Participation will end after 18 months.   "
106908|NCT01886716|"     The purpose of this research is to test a computerized intervention for people with     co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms     by shifting attention away from alcohol-relevant and/or socially threatening cues. The     investigators expect that participants receiving alcohol or anxiety training will experience     reductions in those specific symptoms compared to participants in a control condition. The     investigators also expect that participants receiving combined alcohol and anxiety training     will show the largest reductions in alcohol and anxiety symptoms, relative to participants in     any other condition.   "
106909|NCT01886703|"     This pilot study will assess whether a supported pedometer-based walking program is helpful     in maintaining physical activity for breast and head-and-neck cancer patients who are     undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide     support for physical activity during radiation therapy. We will also examine the relationship     of physical activity and quality of life outcomes to help inform future research.   "
106877|NCT01887119|"     The prevalence of obesity and obesity-related complications is currently taking epidemic     proportions. These complications increase the risk of type 2 diabetes and cardiovascular     disease, which are important causes of morbidity and mortality worldwide.      It is important to gain insight in the mechanisms underlying obesity-related complications,     because this may lead to the development of directed therapeutic strategies.      Currently, there is significant evidence that the cause of both insulin resistance and     hypertension must be sought at the level of the microcirculation.      Over activity of the renin-angiotensin-aldosterone system is a potential cause of     microvascular dysfunction. Angiotensin II was indeed found to be implicated in the     pathogenesis of obesity-associated hypertension and insulin resistance, possibly through     interference with the vascular effects of insulin.      Increased aldosterone levels have also been associated with resistant hypertension and     insulin resistance, which is illustrated in patients with primary aldosteronism. Furthermore,     aldosterone is known to exert several detrimental effects on the vasculature, some of which     are offset by mineralocorticoid receptor antagonists.      In obese individuals, plasma aldosterone concentrations are increased as well. We hypothesize     that increased aldosterone levels in adipose persons induce microvascular dysfunction, which     contributes to the development of insulin resistance and hypertension, and mineralocorticoid     receptor antagonism results in improved insulin sensitivity and decreased blood pressure by     counteracting the adverse effects of aldosterone on the microvasculature.   "
106878|NCT01887106|"     The purpose of this First-in-Human study is to evaluate the safety and tolerability after     single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo.     Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to     healthy male subjects daily for 14 days compared to placebo, will be evaluated.      Furthermore, during the course of the study after single and multiple oral dose     administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as     well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be     characterized compared to placebo.      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205     will be explored.   "
106879|NCT01887093|"     It has been well known that moderate and regular levels of physical activity has a favorable     effect on many of the established risk factors related to coronary artery disease (CAD).     Given that exercise in the morning has a greater potential for inducing sudden cardiac death     and myocardial ischemia, it may be sensible for patients with CAD not to take exercise at     this time. Our previous study indicated that the protective effect of exercise in the evening     was greater than morning. However, which times of day to exercise could achieve the greatest     improvements in lipids and inflammatory markers remains unclear. The purpose of the present     study was to investigate the responses of lipid profiles and inflammatory markers to walking     at different times of day in sedentary patients with CAD.   "
106880|NCT01887080|"     The aim of this study was to investigate the effects of electric stimulation     (electrolipolysis) in a home-based cardiovascular rehabilitation program in patients with     acute myocardial infarction   "
106881|NCT01887067|"     To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension     and its effect on glucose metabolism in patients with type 2 diabetes mellitus   "
106882|NCT01887054|"     This study is designed to evaluate whether a specific visuospatial training task will change     gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of     gait.   "
106883|NCT01887041|"     To compare the quality of life (QoL) in patients receiving a bilioenteric anastomosis vs.     endoscopical stenting for palliation of biliary obstruction due to locally unresectable or     metastatic pancreatic cancer. In the past, endoscopy seems to have been favoured based on     older studies, but with new chemotherapeutic regimens available, the likelihood to experience     stent complications has increased. Therefore, the issue as to which palliation should be     favoured has to be reconsidered.   "
106884|NCT01887028|"     Use lay language.      The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12     mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in     peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low     Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum     may be better in minimizing adverse effects on surgical peritoneal environment and improving     clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard     cool, dry CO2 gas.   "
106885|NCT01887015|"     To evaluate whether early application of nasal high flow oxygen therapy after extubation can     reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) after     abdominal surgery in patients with intermediate to high risk of postoperative pulmonary     complications.   "
106886|NCT01887002|"     The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by     rectal distention in female patients with IBS-D   "
106887|NCT01886989|"     This study aims to investigate the postprandial effects of cocoa supplementation in glucose     and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The     investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal     breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in     patients with diabetes. Randomized cross-over controlled trial, in which participants will be     assigned to the placebo or cocoa group with breakfast meal. Patients with type 2     diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups     cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive     high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI)     measurements will be conducted at fasting, 30 min, 1,2, 4 & 6 hours postprandial each day for     2 days.   "
106888|NCT01886976|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous or donor-derived T cells may make the body build immune response to     kill cancer cells.      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in     treating patients with CD138 positive multiple myeloma that is relapsed (after stem cell     transplantation or intensive chemotherapy) or refractory to further chemotherapy.   "
106910|NCT01886690|"     This study will compare the safety and efficacy of a new eye drop formulation with REFRESH     PLUS® in participants following LASIK surgery.   "
106889|NCT01886963|"     The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell     Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound     complications after complex ventral hernia repairs. Complex ventral hernia repairs are     associated with a high rate of wound complications. To a large degree these complications are     caused by creating tissue advancement flaps to close the abdomen, which can compromise the     blood supply to the skin and subcutaneous tissues. The current standard of care for     assessment of blood perfusion to the flaps is a surgeon's clinical judgment. It is, however,     often inaccurate. The Spy Elite System was developed to address this problem. The Spy Elite     System is a device that enables surgeons to visualize and evaluate tissue perfusion in real     time. It can help the surgeon to identify optimal flap design and reduce the risk of     postoperative wound complications related to tissue ischemia. The primary goal of this study     is to evaluate the efficacy of Spy Elite System to aid a surgeon in creating tissue flaps     with adequate blood supply through a prospective, randomized clinical trial. The Spy Elite     System has been used successfully for assessing the viability of mastectomy flaps in breast     surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis.     However, no clinical trial has been conducted in order to evaluate the efficacy of the Spy     Elite System for assessing the viability of abdominal subcutaneous flaps in complex ventral     hernia repairs.   "
106890|NCT01886950|"     A study of the natural history of bone and mineral disease (BMD) in patients with end-stage     renal disease before and after kidney transplantation   "
106891|NCT01886937|"     The goal of this study is to determine whether one week of phentermine compared to placebo     administration results in changes in food intake during a laboratory meal.   "
106892|NCT01886924|"     The long-term goal of this program of research is to disseminate an effective, brief     computer-based intervention that can be readily integrated into HIV treatment settings to     motivate tobacco quitline use among smokers living with HIV. The overall objective of this     application is to develop this computer intervention, modify it based on initial piloting and     feedback, and obtain preliminary data supporting the efficacy of the intervention. This will     be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot     testing (n=16) of a brief, computer-based intervention intended to motivate tobacco quitline     use among cigarette smokers living with HIV (Computer Intervention to Motivate Engagement in     Tobacco Quitline treatment; CI-METQ) and to develop and pilot (n=4) a computer-based, time     matched nutrition education for PLWH control intervention (NC) equated for the offer of a     tobacco quitline referral and 8 weeks of free nicotine patch for those who engage in quitline     treatment, 2) to conduct a preliminary smoking cessation, randomized controlled trial (RCT)     with 100 people living with HIV (PLWH) who smoke cigarettes, comparing CI-METQ vs. NC, with     predictions that CI-METQ relative to NC will result in increased readiness, higher rates of     tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point     prevalence abstinence rates at 1-, 3- and 6-month follow-ups. Health-related quality of life     over this period will also be examined, and 3) to examine CI-METQ's effects on key mechanisms     during the computer session and their associations with tobacco treatment engagement and     smoking outcomes at 1- and 3-month follow-ups.   "
106893|NCT01886911|"     This project is focused on the neural and behavioral correlates of two different videos games     that will be used as training tools. The two video games, developed by the Games Learning     Society research group at the University of Wisconsin-Madison (UW) and the Wisconsin     Institute for Discovery, are tailored to train mindfulness, particularly the regulation of     attention; and prosocial behavior, especially sensitivity to others, in adolescents. This     study will evaluate the hypothesis that systematic playing of mindfulness and prosocial games     will change brain function in specific attentional, social and emotional circuits in     potentially beneficial ways, and will impact performance on cognitive tasks of attention, and     on measures of social cue perception and the propensity to share and behave altruistically.     The investigators will employ behavioral and functional MRI-based neuroimaging measures to     evaluate the investigators hypothesis.   "
106894|NCT01886898|"     The primary objective of the trial is to assess the growth of the infants enrolled into the     study. Other parameters to be measured include microbiota balance and certain blood     biochemical values. In addition the infants' digestive tolerance of the formulae and     frequency of morbidity will be investigated.   "
106895|NCT01886885|"     The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic     Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and     increase pain acceptance in participants with chronic pain. The secondary objective is to     explore if MBCPM will reduce depression and increase quality of life and mindfulness in the     same group of participants. The additional aim of the pilot study is to evaluate the     feasibility of conducting the MBCPM intervention in participants with chronic pain. We     hypothesize that participants with chronic pain will show relatively good compliance with     completing the MBCPM protocol and will show increased satisfaction associated with     improvement in pain-related and other psychosocial indicators of functioning.   "
106897|NCT01886859|"     This phase I trial studies the side effects and best dose of lenalidomide when given together     with ibrutinib in treating patients with chronic lymphocytic leukemia or small lymphocytic     lymphoma that has returned after a period of improvement or does not respond to treatment.     Biological therapies, such as lenalidomide, may stimulate the immune system in different ways     and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Giving lenalidomide together with ibrutinib may     work better in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.   "
106924|NCT01886508|"     The investigators designed this multicentre randomized study to investigate the clinical     benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage     Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to     either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are     urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace,     cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients     (120 per treatment arm) are planned to accrue for this study within 7 years.   "
106925|NCT01886495|"     The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory     factors among overweight and obese children.   "
106899|NCT01886833|"     Zambia recently introduced routine infant immunization against rotavirus - the most important     cause of severe gastroenteritis and diarrhoea mortality in children. Although vaccines like     Rotarix are a cost effective tool against infectious diseases, live oral vaccines can be less     immunogenic and efficacious in developing world settings as compared with industrialized     countries. Reasons behind this phenomenon are not well understood, but may relate to     continued maternal antigen exposure and high level maternal immunity that is passed to the     foetus/newborn transplacentally and/or through breast milk.      Therefore, three arising hypotheses include: (i) high-level rotavirus-specific maternal     immunity (in the form of anti-rotavirus breast-milk IgA and transplacental serum IgG) is a     major contributor to failed seroconversion following infant vaccination. (ii) Malnutrition     negatively impacts infant immunity and increases the risk of post-vaccination rotavirus     gastroenteritis. (iii) Introduction of rotavirus vaccine will alter the molecular     epidemiology of circulating rotavirus strains detected in vaccinated children presenting with     severe diarrhea.      To address these hypotheses, the proposed study will recruit a prospective cohort of 420     mother-infant pairs. These will be enrolled at the time of vaccination and followed for up to     four years. Baseline immunological status will be ascertained and seroconversion rates     determined a month after full immunization. Incident rotavirus gastroenteritis will be     monitored in the vaccinated infants whenever episodes of diarrhoea occur; through this     surveillance, the sero-strains of rotaviruses causing disease will be tracked over the four     year period. Contributions of HIV infection both in mothers and infants, vitamin A and zinc     deficiency, weight for age Z-scores as well as mid upper arm circumference will also be     assessed. Knowledge gained from this study will inform future interventional trials on     strategies to improve rotavirus vaccine effectiveness in the developing world.   "
106900|NCT01886820|"     To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral     β-Amyloid When Compared With Postmortem Histopathology   "
106901|NCT01886807|"     Patient demographics (age, height and weight) will be collected for 546 consecutive patients     presenting for dental restoration under general anesthesia. The baseline saturation will be     recorded. The induction of anesthesia will be standardized for all patients. All patients     will undergo an inhalational induction administered by face mask. After inserting an     intravenous (IV) line, rocuronium will be administered. Intravenous propofol and fentanyl     could be added at the discretion of the anesthesiologist. The patients will be mask     ventilated then be with a mixture of Air/Oxygen (O2) to achieve an FiO2 of 0.3 for 3 minutes     after the administration of rocuronium.      Patients will be randomly assigned to one of three groups for the purpose of airway     management: 1) direct laryngoscopy for nasotracheal intubation without oxygen insufflation     (DL group); 2) direct laryngoscopy for nasotracheal intubation with oxygen insufflation (DLO2     Group); and 3) nasotracheal intubation using the Truview PCD video laryngoscope (VL Group).     Computer-generated treatment allocations (using the PLAN procedure in SAS statistical     software, using random-sized blocks) will be maintained in sequentially numbered sealed     envelopes that will be opened after consent is obtained. The laryngoscopy and intubations     will be performed by the study investigators who are faculty anesthesiologists or by the     mid-level or resident or fellow working with them.      The study will be stopped when:        -  the patient will be intubated and a CO2 trace is obtained on the capnography or        -  if the patient desaturates to 90%        -  or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or          hypotension)      Randomized groups will be compared for balance on potentially confounding baseline variables     using descriptive statistics. Primary outcome: In the primary hypothesis, desaturation will     be characterized using both time to 1% saturation drop from the baseline and the rate (slope)     of desaturation after an initial 1% drop. We will consider a given intubation technique (DLO2     or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on     both outcomes and superior on at least one of the outcomes. Thus our primary hypothesis will     be assessed in a joint hypothesis testing framework described by Mascha and Turan. We     a-priori define the non-inferiority delta for the outcome time to 1% drop as 5 seconds (or     1.05 if using hazard ratio) and the slope delta as 0.05 percent per second.   "
106902|NCT01886794|"     Our primary aim in the current study is to determine important tissue differences, including     muscle and connective tissue changes, between postmenopausal women and reproductive age women     with pelvic floor dysfunction to help develop targeted and noninvasive treatments.   "
106903|NCT01886781|"     In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy     and will the probiotic influence gut microflora and thus improve clinical outcomes, as     compared to no intervention.   "
106904|NCT01886768|"     Unsedated ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with     conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective     and time-efficient. The investigators and in other studies have showed that nasal pledgetting     (or commonly termed nasal packing) is better than nasal spray in terms of patient tolerance     and visual capacity. Although pledgetting method to a selected meatus can achieve better     decongestion effect, epistaxis and nasal pain in some patients are still frustrating to     endoscopists.      The investigator has proposed a novel meatus scoring scale to evaluate nasal insertability by     anterior rhinoscopy using a transnasal endoscope. The investigator also suggest     endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing     trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal     endoscopy. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least     the posterior end of a turbinate. We hypothesize that by using endoscopic-guided method,     gauze pledgetting to both the inferior nasal meatus (INM) and middle nasal meatus (MNM)     simultaneously is more tolerable than only gauze pledgetting to a single meatus.   "
106905|NCT01886755|"     An ORS with L. reuteri DSM 17938 and zinc is expected to reduce duration and severity of     symptoms in infants and young children with acute gastroenteritis.   "
106906|NCT01886742|"     The population continues to increase in weight. Currently there are no guidelines in the     dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for     patients <120 kg and 3 grams for patients >120 kg is used as the dose for surgical     prophylaxis. This makes no provisions for weight based dosing. There has been some recent     data which states this might not be enough for the obese patients. The primary objective of     this study is to determine if weight based dosing (30 mg/kg) of cefazolin as surgical     prophylaxis for patients undergoing elective gastric bypass/laparoscopic Roux-en-y gastric     bypass provides appropriate serum concentrations for a larger percentage of time than the     current method of giving the standard 2 or 3 gram doses of cefazolin peri-operatively. The     concentration of cefazolin in tissue will also be measured to help assess this question.   "
106907|NCT01886729|"     The treatment for patients with acute tinnitus consists of Methylprednisolone and hyperbaric     oxygen therapy. For this study transcranial direct current stimulation (tDCS) was added to     the protocol. The purpose is to determine the effect of the time shift of tDCS. Two     conditions will be compared: tDCS simultaneously with the hyperbaric oxygen therapy or tDCS 3     weeks after the start of the tinnitus.      An audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks and     12 weeks.   "
106911|NCT01886677|"     RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and     energy balance may play a major role in prostate cancer progression.      PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy     energy-restricted diet and exercise, in slowing or preventing disease progression in patients     who have newly diagnosed prostate cancer.   "
136352|NCT01500018|"     This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to     placebo, ketamine, and phentermine in healthy recreational polydrug users.   "
106914|NCT01886638|"     HIV positive patients have a two fold increased risk of developing cardiovascular disease     (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to both     HIV and the side effects from anti-HIV medications.      Abacavir (an important component of current HIV treatment regimens) is one medication shown     to be associated with an increase the risk of heart attacks in some studies. The mechanism by     which abacavir does this is unknown.      We hypothesise that abacavir is leading to heart disease by interacting with platelets, which     then form blood clots within the arteries supplying the heart, the subsequent blockage of the     artery causing a heart attack.      This study aims to determine if abacavir increases the activity (or stickiness) of     platelets, and thus provide evidence as to how it may be promoting heart attacks.      It will consist of 23 HIV positive men who currently have well controlled HIV. Participants     will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood     sample to assess platelet activity will be taken at baseline, following the 15 days of     therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout period     (to determine if any effects are reversible).   "
106915|NCT01886625|"     Background of the study: CRPS type-1 is a pain syndrome that usually develops after an     initiating noxious event (e.g. fracture) in an extremity. Although treatment options life     dimethyl-sulphoxide (DMSO), N-acetylcysteine (NAC) and intensive physical therapy exist, the     treatment effect is often unsatisfactory, even leading to amputation of the extremity.     Surgical treatment of chronic pain disorders by dividing the sympathetic chain is an     established treatment. Its more invasive nature has prevented widespread application. After     introduction of minimal invasive techniques in recent years, the UMCG has now devised a truly     minimal invasive, yet safe and effective thoracoscopic technique, that requires only a single     1 cm long incision in the anterior axillary line. This technique is developed as treatment     for primary focal axillary and palmar hyperhidrosis, and is performed in over 50 patients     producing very satisfying results. This fact has led to the hypothesis that this same     surgical technique can offer this group of chronic pain patients a safe, effective treatment     modality.      Objective of the study: The effect of the intervention on pain an regain of function in de     affected extremity. This will be quantified in multiple questionnaires at baseline and three     follow-up points, and by clinical evaluation of the hand function at baseline and two     follow-up points.      Study design: Single center prospective feasibility study   "
106916|NCT01886612|"     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among     hospitalized patients, with death occurring in approximately 6% of cases. It involves the     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to     blood vessel wall), collectively known as Virchow's triad.      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have     been shown to improve lower limb blood flow. However, few studies have directly compared the     two methods and those that have, have used dated NMES techniques.      The objective of this study is to compare the two methods in terms of blood flow.   "
106917|NCT01886599|"     The purpose of the study is to determine how Asunaprevir is handled by the body of subjects     with kidney disease compared with subjects with normal kidney function   "
106918|NCT01886586|"     This study will adapt Problem Solving Therapy (PST) for individuals with mild cognitive     impairment (MCI) as an intervention for preventing major depression (DEP). PST will be     modified so as to be provided to both MCI probands as well as their support person. The     primary aim is to examine the effectiveness of PST in individuals with MCI and the support     person, at preventing DEP over 12 mos. in MCI probands. We also will examine the effect of     exercise on preventing depression.   "
106919|NCT01886573|"     This pilot clinical trials studies azacitidine and entinostat in treating patients with newly     diagnosed stage IA-IIIIA non-small cell lung undergoing surgery. Drugs used in chemotherapy,     such as azacitidine, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Entinostat may stop the growth of cancer     tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with     entinostat may be an effective treatment for non-small cell lung cancer.   "
106920|NCT01886560|"     To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal     burn.   "
106921|NCT01886547|"     We aim to determine the effectiveness of 2013 Mag paDRE ka programme in increasing general     public awareness on prostate health and promoting prostate health assessment among Filipino     males aged 40 or older.   "
106922|NCT01886534|"     Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at     hospital discharge which may impact their ability to make effective decisions about their     healthcare. However, informal care partners (CPs) may assist in managing HF when provided     with appropriate education and support. The goal of this randomized clinical trial (RCT) is     to evaluate an intervention which will provide 1) additional teaching on management of HF to     the patient and CP following hospital discharge, 2) improved communication with the family     physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital     talking scale. The investigators believe this intervention will improve outcomes and be cost     saving.      The investigators hypothesize that enhanced education and support for the CPs to assist older     HF patients following hospital discharge, combined with improved communication with family     physicians, contact with a HF nurse, and simple decision support tools, will lead to earlier     recognition of clinical deterioration, and improved patient outcomes. Innovative and     cost-effective approaches to manage HF patients following hospital discharge are urgently     needed in Canada.   "
106923|NCT01886521|"     Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain     in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic     neurological deficits but failed to show a clinical benefit after 6 months. The underlying     assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher     concentration of blood than CSF from lumbar drains. The investigators decided to test this     assumption. In this study, the investigators will randomize patients to either placement of a     ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.   "
136379|NCT01499667|"     This study evaluated disease control during different lengths of treatment transition from     natalizumab to fingolimod.   "
106928|NCT01886456|"     To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective     laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients     suffering from open-angle glaucoma or ocular hypertension.      Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as     2, 3, 6, 9, 12, 18 and 24 months after treatment.        -  Trial with medical device   "
106929|NCT01886443|"     The purpose of this study is to establish the safety of the combined drug approach     (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta,     C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce     ischemia-reperfusion injury during liver transplantation in eligible recipients.   "
106930|NCT01886430|"     The purpose of this study is to verify the effects of low frequency functional electrical     stimulation in heart failure patients hospitalized for treatment of the syndrome.   "
106931|NCT01886417|"     Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant     external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring     would cause the verbal thoughts of the patient to be perceived as external voices resulting     in AVHs.      In order to examine whether AVHs correspond to self-generated inner speech, the present study     aims at collecting speech muscle activity during covert AVHs (without articulation), overt     speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and     control subjects to detect any speech muscle activity during AVH.   "
106932|NCT01886404|"     The primary purpose of this study is to investigate the steady-state pharmacokinetics of     efavirenz in older HIV-infected patients as compared to historical controls; to investigate     the relationship of drug exposure to neuropsychiatric side effects and neuropsychological     performance; and to explore the role of host polymorphisms in drug metabolism in the older     patient.   "
106933|NCT01886391|"     The purpose of this study is to provide information on how the practicing of deep     breathing(DBR - diaphragmatic breathing re-training)may improve the health outcomes and     likelihood of heart failure patients to engage in health-promoting activities by successfully     controlling their shortness of breath (dyspnea).   "
106934|NCT01886378|"     UX007-CL201 is an open-label Phase 2 study to assess the safety and clinical effects of UX007     in subjects with LC-FAOD. Following a 4 week run in period on current therapy, subjects will     cross over to daily UX007 treatment for an initial 24 week treatment period, followed by an     additional 54 week extension period. Approximately 30 subjects at least 6 months of age     inclusive with severe LC-FAOD, specifically VLCAD, LCHAD, CPT 2, or TFP disorders, will be     enrolled and treated with UX007.   "
106935|NCT01886365|"     The debate about tight glycemic control (TGC) in the operating room and on the intensive care     unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due     to high blood glucose levels during operations and subsequent high rates of sternal wound     infections. We showed in a feasibility study that early computer based insulin therapy     starting in the operating room is a safe therapy that allows to better warrant normoglycemia     in patients undergoing major cardiac surgery with the use of blood cardioplegia.   "
106936|NCT01886352|"     In this study, we will compare 3 treatments. The first group of patients will receive the     standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of     the portal sites with the local anesthetic ( 0.5% levobupivacaine) . The second group of     patients will receive the standard of care, with infiltration of the portal sites with the     local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic (     0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the     beginning and the end of the surgery . The third group of patients will receive the standard     of care, with infiltration of the portal sites with the local anesthetic ( 0.5%     levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will     use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the     beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray     device, an inexpensive delivery system that will direct a fine mist of drug directly to the     areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms,     peritoneal abdominal surface, surgical dissection site).      Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine     in reducing postoperative pain and of opioid requirements in patients undergoing     gynecological laparoscopic procedures in one-day surgery.   "
106948|NCT01886196|"     Inflammation increases with aging and is implicated in the reduction of bone mass, muscle     mass, and strength. Resistance training is safe and effective for increasing muscle mass and     strength in older adults,however resistance training by itself cannot suppress inflammation.     Ibuprofen is a non-steroidal anti-inflammatory drug that may provide benefits to muscle mass     and strength when given after resistance training sessions in older adults; however, more     evidence is required to confirm effects across the lifespan. The objectives are to determine     the effect of 9 months of exercise training and ibuprofen supplementation, compared to     placebo, in older women (≥65years)on the following dependent variables:        -  bone density, geometry, and architecture        -  muscle mass and strength        -  balance   "
136839|NCT01493726|"     This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072     (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.   "
106937|NCT01886339|"     SNIF test has been described as a method to explore the diaphragmatic function. But there are     no defined the reference values of this test in healthy population. The investigators'     hypothesis is that there is a variation on SNIF values in Mediterranean population depending     on gender, age and anthropometric variables such as height and weight.      The investigators will analyze 1000 SNIF test of healthy people. The investigators will     divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the     investigators will study 100 men and 100 women.      All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and     SNIF. If spirometry and MIP are correct the investigators will consider that person has a     correct diaphragmatic function and strength. Then the investigators will measure the SNIF     test. With all of these SNIF values the investigators will try to achieve the reference     values of this test in the different groups of age in Mediterranean population. And the     investigators will compare SNIF with MIP.      Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar,     Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital     de la Vall d'Hebrón.   "
106938|NCT01886326|"     Evidence is accumulating that peanut consumption confers health benefits, such as reduction     of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et     al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight gain     are widespread. Although research indicates that other characteristics of peanuts offset     these properties, and that peanuts may be incorporated into diets without posing a threat to     weight gain (Mattes et al., 2008), concern remains among policymakers, healthcare providers,     and consumers. Furthermore, worry exists that eating salted peanuts may elevate blood     pressure and that eating honey-roasted peanuts make elevate blood sugar. These fears create     substantial obstacles to increased peanut consumption.      Recommendations to increase peanut consumption may be made, but if they are not followed,     there will be no impact on health. Additional knowledge is needed on: (1) the acceptability     of peanuts consumed on a chronic basis, (2) the chronic intake of moderate levels of peanuts     and body weight, and 3) the effects of peanuts on blood pressure and blood sugar. The     proposed research will examine the acceptability of long-term inclusion of a single form     versus varied forms of peanuts in the diet. It is expected that responses will be varied     among individuals with different personality characteristics (e.g., prefer sweet versus     savory foods, hedonic versus non-hedonic eaters). A better understanding of how different     segments of the population choose to include peanuts in their diet and how to optimize     long-term consumption should provide insights for better marketing and improved health.     Furthermore, it is anticipated that eating salty peanuts will not raise blood pressure and     that eating honey-roasted peanuts will not raise blood sugar. Documenting this will add     credibility to the evidence that peanuts do not cause weight gain, as well as reinforce     recommendations to increase peanut consumption for their health benefits.   "
106939|NCT01886313|"     Herpes zoster (commonly referred to as shingles) results from the reactivation of the     varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus     lays dormant in the cells of the nerves until activated. Once activated, patients develop a     characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic     neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is     the most common and most feared complication of herpes zoster infection. The drug, Civamide     is thought to desensitize the nerves and decrease the pain of PHN. This is the pharmacologic     rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve     that is in the nose and transmits pain from the face. The objective of this study is to     evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the     treatment of moderate to severe daily pain associated with postherpetic neuralgia of the     trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.   "
106940|NCT01886300|"     This prospective, multicenter, observational study will evaluate the sustained response in     patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to     standard of care and in line with the current local labeling in routine clinical practice in     Vietnam. Eligible patients will be followed for the duration of their treatment and for up to     2 years thereafter.   "
106941|NCT01886287|"     The primary purpose of the study is to investigate the effects of high-dose octreotide on     flushing, diarrhea, and quality of life in patients whose disease-related symptoms are     inadequately controlled by the maximum approved dose of octreotide LAR.   "
106942|NCT01886274|"     Migraine has been described as one of the most common neurological diseases, with high social     and economic impact. Despite the high prevalence, the pathophysiology of migraine is still     unknown, several studies have been developed in order to advance the understanding of the     pathophysiological mechanisms of the disease which are not yet entirely elucidated. The aim     of this study is to observe the effects of transcranial direct current stimulation (tDCS),     applied in the visual cortex, on neurophysiological and clinical measures (frequency,     intensity, duration of attacks and severity of pain) in migraine patients.   "
106943|NCT01886261|"     Usability of the PALMS system, validity of the PALMS system and added value to an existing     cohort study.      Hypothesis: Addition of GPS device and use of PALMS system will allow researchers to better     examine place-based interventions.   "
106944|NCT01886248|"     To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive     diseases following hematopoietic stem cell transplantation.   "
106945|NCT01886235|"     This pilot clinical trial studies intravital microscopy for identifying tumor vessels in     patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures,     such as intravital microscopy, may determine the extent of melanoma.   "
106946|NCT01886222|"     This study is a prospective multi-centre randomized trial to compare the effect of long-term     mild hypothermia versus routine normothermic intensive management in patients with severe     traumatic brain injury.      The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5     days will improve the outcome of patients at six months post injury compared with     normothermia.   "
106947|NCT01886209|"     This study is designed to evaluate the effect of VX-509 on the pharmacokinetics (PK) of     corticosteroids (prednisone or methylprednisolone) and the effect of corticosteroids on the     PK of VX-509 and its metabolite. The study will also evaluate the safety and tolerability of     VX-509 when coadministered with each of these corticosteroids.   "
106949|NCT01886183|"     The objective of this work will be compare the effects of two balance training programs, one     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,     on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke     patients. It is a prospective, single blinded, randomized clinical trial performed at Center     of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of     São Paulo University. Forty patients will be randomly assigned in control and experimental     group, 20 each one.   "
106950|NCT01886170|"     In this two-phase mixed methods study, the investigators will first use patient feedback from     semi-structured interviews to explore the ways in which patients with diabetes understand     their diabetes and assess their disease control. The investigators will also use these     interviews to elicit patient feedback on promising alternative communication formats to the     hemoglobin A1C (A1C). In the second phase of the study, the investigators will test new     formats to communicate information regarding diabetes control to patients with poorly     controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C (standard     medical information) versus two alternative formats on several participant outcomes,     primarily glycemic control at 6 months post-intervention.   "
106951|NCT01886157|"     Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior     to corticosteroid treatment alone.   "
106996|NCT01885572|"     This multicentre, non-randomised, observational clinical device investigation will be     performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the     improvement of the patients' quality of life as well as on the rate of complications of the     device under investigation.      The objective of this clinical investigation is to establish the feasibility, efficacy and     safety of the TiLOOP® Bra.   "
106952|NCT01886144|"     Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness     that commonly alter the way one will climb stairs and walk reducing an individual's function     and the activities they may perform on a day-to-day basis. Providing a person with a knee     brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain     and lead to improved function. The purpose of this study is to determine if use of the Rebel     Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve     strength and balance, and enhance functional activities such as stair and level gait, and     ultimately lead to increased participation in the community.   "
106953|NCT01886131|"     To compare the electrical activity of SubThalamic Nuclei (STN), by mean of local field     potentials recordings, during the phasic behaviours of RBD with the electrical activity     recorded at this level during the execution of voluntary movements during the off and the     on phases in patients with RBD secondary to PD.   "
106954|NCT01886118|"     One of the main factors in the success of in-vitro fertilization is the quality of the     environment of the embryo. In contrast to maternal age, the environment in which the embryo     develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting     culture media have been attempted in order to reproduce as much as possible the natural,     physiological environment of the mother for the embryo in in-vitro fertilization. However,     the different new culture media used are devoid of growth factors normally secreted by     uterine cells that enhance the interaction between the embryo and its environment.      Because the endometrial lining of the uterus secretes many different cytokines necessary for     growth of the embryo, a new procedure has been developed to mimic the natural environment of     the growing embryo using autologous (patient's own) endometrial cells in co-culture with the     embryo. Endocell, a product developed by Genévrier Laboratories, received commercial     authorization in France in 2011. It is the only system of autologous embryo-endometrium     co-culture available on the actual market. The process consists of developing the embryo on a     monolayer of the patient's own endometrial cells in order to favor its growth until the     blastocyst stage (day 5) and to improve its implantation.   "
106955|NCT01886105|"     The primary goal of this study will be to examine tumor response after radiation treatment     via a combination of Samarium-153 EDTMP and external beam radiotherapy.   "
106956|NCT01886092|"     Efficacy of different protocols of transcranial magnetic stimulation for the treatment of     tinnitus   "
106957|NCT01886079|"     The purpose of study is to compare the incidence of acute kidney injury in patients receiving     perioperative dexmedetomidine or placebo undergoing valvular heart surgery.   "
106958|NCT01886066|"     The standard of care for women with high risk endometrial cancer is the removal of all     visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to     these areas. It is estimated that no more than 25% of all women with presumed early stage     high risk endometrial cancer will have positive lymph nodes however currently the majority of     women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph nodes     and its associated morbidities. The objective of this study is to determine if intraoperative     sentinel lymph node (SLN) mapping will improve the assessment of regional lymph nodes and     enhance the detection of lymph nodes with metastatic disease in endometrial cancer. This     would benefit the majority of women with early stage high risk endometrial cancer and would     prevent the associated complications of pelvic lymph node dissection.   "
106959|NCT01886053|"     The purpose of this study is to evaluate the safety and Efficacy of Faropenem in     community-acquired pneumonia (CAP) subjects，and explore its therapeutic dose.   "
106960|NCT01886040|"     Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has     been overcome the epithelial ovarian cancer because of the change of life style to western     style recently. Most patients with endometrial cancer are stage I & II, the most histology is     still endometrioid adenocarcinoma (type I endometrial cancer). In statistics, advanced     stage (FIGO stage III and IV) is approximately 16% of all cases.      Most patients has good outcome of endometrial cancer because their surgical stage is belonged     to early stage. However, the recurrence, distant metastases and mortality are high if the     diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking     operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy.     Whether the adjuvant therapy can cure the disease of not is still controversial.      Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic     modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy     and radiation therapy or sequential sandwich therapy were ever used for such group patients     in each medical center. But the case number is insufficient and limited to show the survival     or progression free benefit during the statistics. Besides, the surgical procedures and     adjuvant therapy for early endometrial cancer is still remained to be determined. The     investigators are also interested to analyze the factors affecting their survival.      The investigators will perform a retrospective study to review the data of patients with     endometrial cancer in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital.   "
106970|NCT01885910|"     This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel     following combination treatment with with doxycycline and Aczone 5% gel can maintain     therapeutic response.   "
107117|NCT01883999|"     The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized,     multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE     Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).   "
106961|NCT01886027|"     The primary goal of this study is to test the efficacy of emotional awareness and expression     training (EAET), a novel emotional processing intervention that the investigators have     developed, for people with IBS. In this randomized, controlled trial, the investigators will     compare EAET to a standard intervention that teaches the conceptually opposite     approach—relaxation training (RT)—and test how both of these interventions compare to a     wait-list control condition. The investigators hypothesize that individuals in the EAET group     will demonstrate greater improvement in their IBS symptom severity, psychological     functioning, quality of life, and health care utilization at 4 and 12-week follow-up time     points, compared to individuals in the wait-list control group. It is also expected that both     of the active interventions (EAET and RT) will be more efficacious than the wait-list control     condition.   "
106963|NCT01886001|"     Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care     Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can     occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs).     This study is a prospective, randomized controlled feasibility trial to evaluate three types     of hygiene products on umbilical line stumps, on the effect of line colonization and     subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be     randomized into one of four study groups, three products against standard of care (no     product). The three products that will be evaluated are currently being used in different     capacities for skin care in the UVA NICU. The study hypothesizes that daily topical     application of 1 or more antiseptic to the top of the umbilical stump will decrease     colonization of the umbilical stump while umbilical lines are in place.   "
106964|NCT01885988|"     The study will take part at The Men's Health Center It will involve men who have a diagnosis     of erectile dysfunction and also have high blood pressure.      High blood pressure can affect the lining of the arteries and cause stiffness in the     arteries. The arteries and veins throughout the body have a lining called the endothelium     which gives them the ability to stretch. If the lining of the penile arteries becomes     impaired, it can decrease the stretching of the artery and decrease blood flow. Decreased     blood flow in the penile arteries can cause problems obtaining an erection.      The study medication Nebivolol controls blood pressure by relaxing smooth muscle around the     lining of the arteries, thereby improving stretch and blood flow.      The primary objective is to determine if treatment with nebivolol improves endothelial     function and erectile function in men with pre-hypertension and stage 1 hypertension      70 men will be enrolled into the study. Half of the subjects will receive active medication     and half will receive a placebo. All men will receive educational informational handouts     about blood pressure and behavior modifications to improve blood pressure. The study will     last for 3 months for each subject. The expected recruitment time is one year, with a 2 year     study completion goal. Subjects will have approximately 5 study visits.      Subjects will have initial/final blood work, a Rigiscan test (a take home penile erection     test), two EndoPat tests to assess endothelium function, 3 SphygmoCor tests to assess central     blood pressure, 2 sexual health questionnaires at 2 visits. Vital signs will be monitored at     each visit to assess safety and effectiveness of the study medication.   "
106965|NCT01885975|"     The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will     manifest a personality profile that differs than that of a population of similar range of     ethnic and socioeconomic status.   "
106966|NCT01885962|"     The investigators propose to test the feasibility of iSHIFTup (Internet Skin Health     Intervention For Targeted Ulcer Prevention) for adults with spinal cord injury (SCI) to     prevent serious pressure ulcers (PrUs) and promote protective health behaviors. This protocol     is Phase 2 of a three phase project. In Phase 1, the investigators developed iSHIFTup. In     Phase 2, the investigators will test the intervention by partnering with Woodrow Wilson     Rehabilitation Center (WWRC) to conduct a randomized controlled trial (RCT) of 18     participants. In Phase 3, the investigators will focus on optimizing the intervention based     on our outcome findings and feedback, sustaining the program at WWRC, and seeking future     funding for a larger RCT.      The investigators will conduct an RCT of up to 18 participants (9 participants in treatment     as usual (TAU) group, 9 participants in TAU + iSHIFTup intervention group) (18 participants     are needed to obtain statistically significant results).      The investigators will meet with potential participants in-person to complete the informed     consent process and confirm eligibility. Participants in the TAU+iSHIFTup group will use the     program during the study period. Participants randomized to TAU will have usual treatment     during the study period and an opportunity to use the program following trial participation.     The investigators will collect information from participants at two times during the study,     at enrollment and post-intervention at 6-weeks (42 days). The investigators will also collect     qualitative information from participants in the TAU+iSHIFTup group, during an optional     focus-group setting, to learn users' experiences with the program. The investigators expect     participants in the TAU+iSHIFTup group as compared to the TAU group, to display greater     awareness of personal risk for pressure ulcers; increased preventive behaviors; and increased     skin care self-efficacy and knowledge.   "
106967|NCT01885949|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational combination of drugs to learn whether they work in treating a specific     cancer. Investigational means that the combination of drugs is still being studied and that     research doctors are trying to find out more about it, such as the safest dose to use and the     side effects they may cause. It also means that the FDA has not yet approved the combination.      The two drugs being tested in this study are tivozanib and enzalutamide. Enzalutamide has     been approved by the FDA for treatment of prostate cancer. On the other hand, tivozanib is     still investigational, and has not been tested in a combination with enzalutamide before.      Enzalutamide is an androgen receptor antagonist (it blocks the activity of the male sex     hormones). Prostate cancers are initially dependent on the male hormone testosterone for     growth. Hormonal therapies that lower testosterone or block the ability of testosterone to     act at the level of the prostate cancer are currently among the most effective treatments for     prostate cancers taht have spread to other body organs (metastasized). The effectiveness of     hormonal treatments, however, is not permanent, and over time many prostate cancers progress     in spite of these treatments. Enzalutamide is a drug that has been proven to help delay the     progression of advanced prostate cancer on average for about 8 months.      Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking     the blood supply to the tumor, so that the tumor does not receive the nutrients it needs to     grow. The main goal of this study is to determine whether the combination of tivozanib and     enzalutamide is more effective in delaying the progression of disease than when enzalutamide     is given alone. This study will also determine whether treatment with the combination of the     tivozanib and enzalutamide will have more side effects then treatment with enzalutamide     alone.   "
106968|NCT01885936|"     In this study the study team proposes to investigate the efficacy of albuterol on motor     function of individuals with Late Onset Pompe Disease (LOPD) who are receiving enzyme     replacement therapy, given albuterol was well-tolerated in patients with Late Onset Pompe     Disease.   "
106969|NCT01885923|"     THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for     schizophrenia and schizoaffective disorder by means of simple, highly cost-effective     information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study     duration, patients in the active group enrolled in ITAREPS will demonstrate statistically     significantly reduced risk of hospitalization, decreased number of hospitalization days and     reduced direct inpatient costs in comparison to control group not using the program.   "
106993|NCT01885611|"     To date, there has been no clinical investigation on the effects of virgin coconut oil (VCO)     oral supplementation on patients with Hansen's disease (HD) undergoing medical treatment.     This study aims to examine the possible protective effect of exogenous supplementation of VCO     on the oxidative stress, antioxidant status, and treatment response among HD patients.     Treatment response will be defined as the clinical changes in cutaneous and neurologic     manifestations as measured by the clinical response score. This study also aims to     investigate the potential of VCO as an adjunct to Multi-Drug Therapy (MDT) in mitigating     lepra reactions.   "
106994|NCT01885598|"     The primary objective of this study is to examine the safety profile of Eliquis in Korean     nonvalvular atrial fibrillation patients.   "
106995|NCT01885585|"     The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the     clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the     safety and effectiveness information about Eliquis in general practice   "
106971|NCT01885897|"     This is a multi-center, phase I/II clinical trial for patients who have relapsed more than 60     day after allogeneic transplant for a hematologic malignancy. The study consists of two     phases. The dose finding phase is a modified version of a phase I trial and the extended     phase is a modified version of a phase II trial.      The primary objective of the dose finding phase is to determine the maximum tolerated,     minimum efficacious dose (MTD/MED) of a interleukin-15 (IL-15) super agonist complex     (ALT-803) when given once weekly for 4 weeks in the outpatient setting. The study will follow     a standard 3+3 design of dose escalation for toxicity with an added feature of stopping early     if efficacy is confirmed. There are six dose levels of ALT-803 for to determine the MTD/MED:     1, 3, 6, 10, 20, and 30 mcg/kg.      Once the MTD/MED for ALT-803 is determined, this cohort will be used in the extended phase.     The primary goal of this extended phase is to study the potential efficacy of ALT-803 in this     patient population. Efficacy will be measured using rates of remission induction. An optimal     Simon's two-stage design will be used in this phase. Stage 1 will enroll 14 patients     (including the 6 patients treated at the MTD/MED during the dose finding phase). If 3 or more     of these 14 patients respond to ALT-803, the trial will move to stage 2 and enroll an     additional 23 patients. If 2 or fewer respond, the study will terminate enrollment early.   "
106972|NCT01885884|"     This is a pilot, randomized controlled trial of an embedded collaborative model of supportive     care designed to improve quality of life and decrease use of unwanted healthcare services at     the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who     are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced     or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and     providers. Patients will be randomized to receive either the supportive care intervention or     usual care. The purpose of this study is to refine an embedded collaborative model of     supportive care and to develop protocols for recruitment, randomization, and longitudinal     data collection.   "
106973|NCT01885871|"     The purpose of this study is to determine whether picosecond laser is effective in the     treatment of age (sun) spots.   "
106974|NCT01885858|"     This study is designed as a crossover randomized controlled trial, to investigate the effects     of client's ethnic characteristics on the quality of family planning services.   "
106975|NCT01885845|"     Postpartum hemorrhage is one of the most common causes of maternal mortality and serious     maternal morbidity, especially in the developing world. In India, hemorrhage is a major cause     of maternal mortality: A study by the Register General in 1993 showed that 23 percent of all     maternal deaths in rural areas were caused by hemorrhage (Sibley, 2005).      The measurement of postpartum blood loss and identification of postpartum hemorrhage are     important measures in efforts to prevent and treat postpartum hemorrhage. In recent years,     researchers have employed several different methods to measure blood loss in hospital and     community-based birth settings. Although research has demonstrated that these laboratory     measures are more accurate then visual estimation techniques, no studies have explicitly     documented the systematic differences (if any) among different collection modalities.     Moreover, only a few of these studies have correlated measured blood loss with changes in     hemoglobin levels experienced between the antepartum and postpartum period. The aim of this     study is to compare variations in the measurement of blood loss obtained using two popular     measurement methods: the Excellent BRASSS-V Drape™ and a modified version of the blood     collection method developed by the World Health Organization (WHO).   "
106976|NCT01885832|"     Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2,     3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment     associated adverse events. Improvements in joint function as assessed by Western Ontario and     McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.   "
106977|NCT01885819|"     Autologous stromal vascular fraction (SVF) injected at 8 and 10 days after extraction is safe     and useful procedure in inducing remission of RA in patients resistant to standard DMARD     therapy.   "
106978|NCT01885806|"     We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation     (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that     rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.   "
106979|NCT01885793|"     This is a prospective study looking at ways to measure the cuff pressure of cuffed     endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer     of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or     central venous pressure monitoring. The investigators previously did this study in vivo with     ETTs in polyvinyl chloride (PVC) tracheas and we found that there is good correlation     between the pressure readings using the MM and the IPMS. The purpose of the current study is     to validate the in vitro findings in clinical situations.   "
106980|NCT01885780|"     This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the     effectiveness of the femtolaser-assisted astigmatic keratotomy.   "
106981|NCT01885767|"     The NF Registry is a database of patient-reported experiences of living with     neurofibromatosis. It also serves as a referral source for clinical trials.   "
106991|NCT01885637|"     Danish studies have shown that the majority of palliative cancer patients wish to be cared     for and spend the rest of their lives at home. Nevertheless > 50% of palliative cancer     patients die in acute hospitals and these figures are found in countries with a highly     developed palliative care service as well. Some studies have suggested that, among other     causes, delays in the discharge process represent a significant obstacle for achieving care     and treatment, and ultimately death at home. Therefore, this randomized controlled trial     (RCT) aims at investigating an accelerated transition program from oncological treatment to     continuous specialized palliative care at home for patients with incurable cancer. The     primary objective of the study is to investigate whether an accelerated transition from     oncology care to palliative home care significantly increases home care and death. The     secondary objectives are to investigate whether the intervention improves symptom control and     quality of life, increases survival, affects health care expenses, improves caregiver quality     of life and burden, dyadic coping and grief outcomes. The study will take place in the     departments of oncology at Rigshospitalet, where palliative cancer patients will enter the     intervention or usual care arms. The intervention is an accelerated transition program, which     consists of planning palliative home care and if needed optimization of facilities at home,     and a transfer to home care within 5 days of informed consent. On day 1 at home the patient,     informal caregiver, nurse, representatives of the specialized palliative care team and if     possible the general practitioner and project psychologist meet to organize home care. A     dyadic psychological intervention is offered to patients and their informal caregiver during     specialized palliative care at home and to bereaved caregivers. The control group will be     treated according to the usual principles, but if inadequate palliative care is observed in     this group, the study group is obliged to involve responsible professionals. Both groups will     be followed by assessments of the patient and the caregiver for up to 6 months and the     caregivers 19 month after the patient's death.   "
106982|NCT01885754|"     Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer     is the leading cancer-related death worldwide and it represents a pressing health issue.     Patients with lung cancer are more likely to experience cachexia, a severe debilitating     disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical     function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in     about 80% of advanced cancer patients is the direct cause of death in about 20% of cases.     However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation     with muscle function and effort tolerance are still unknown.      Aim: To explore muscle function, signaling pathways and its relationship to impaired     functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether     they have cachexic state at diagnosis.      Methods: This study will be conducted at the Institut universitaire de cardiologie et de     pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated     whether or not they have a cachexic state. The evaluation will need two visits separated by 5     days.      During the evaluation the following tests will be done:        -  Anthropometric measures        -  Level of daily physical activity        -  Pulmonary function test        -  Maximal incremental cardiopulmonary exercise test on ergocycle        -  Endurance test on ergocycle        -  Muscle function tests        -  Magnetic stimulation        -  Quadriceps biopsy   "
106983|NCT01885741|"     A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy     (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy     procedures facilitated by the MRI-guided system. Patients will be followed after the     procedure to assess clinical outcomes.   "
106984|NCT01885728|"     The primary objective of this study is to characterize the immune-modulatory effects of     arginine-rich nutritional supplements in patients undergoing surgery. Numerical and     functional changes of all circulating immune cells will be assessed with mass cytometry.   "
106985|NCT01885715|"     This study aims to find appropriate dose of neostigmine which is possible to reverse     rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.   "
106986|NCT01885702|"     Objectives:      In this Radboud University Nijmegen Medical Centre (RUNMC) initiated study our first     objective is to investigate toxicity (safety and feasibility) of vaccination with     frameshift-derived neoantigen-loaded DC of CRC patients with an MSI-positive CRC and persons     who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet.      The secondary objectives of the study are:        -  to demonstrate that peptide-loaded DC can induce or enhance an immune response to          tumor-associated antigen CEA and specific frameshift-derived neoantigens in the study          population.        -  to study the pathological and clinical responses, e.g. disease-free survival, determined          according to the standard protocol.      Study design:      This study is a phase I/II open-label study.      Study population:      Two groups of adults will be vaccinated:      Group I) CRC patients, who are known to carry a germline MMR-gene mutation and patients with     an MSI-positive CRC and yet unknown or negative MMR-gene mutation status.      Group II) persons who are known to be carrier of a germline MMR-gene mutation with no signs     of disease yet. All participants need to be HLA-A2.1 positive.   "
106987|NCT01885689|"     This phase II trial studies how well clofarabine and melphalan before a donor stem cell     transplant works in treating patients with a decrease in or disappearance of signs and     symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic     myelomonocytic leukemia. Giving chemotherapy, such as clofarabine and melphalan, before a     donor stem cell transplant helps stop the growth of cancer cells. It may also stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into a patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Giving clofarabine and melphalan     before transplant may help prevent the cancer from coming back after transplant, and they may     cause fewer side effects than standard treatment.   "
106988|NCT01885676|"     -  Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in          both men and women and is caused by the action of androgens in genetically predisposed          individuals.        -  This clinical trial was designed to evaluate the efficacy and safety of using a          preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment          of androgenetic alopecia.   "
106989|NCT01885663|"     This open label trial is conducted to investigate the efficacy and safety of allogeneic     umbilical cord blood (UCB) therapy for patients with acquired brain injury.   "
106990|NCT01885650|"     Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes     which is characterised by the production of thickened bodily secretions, affecting the     function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is     very difficult to clear, which can results in recurrent chest infections, which can lead to     lung damage. therefore it is important to optimise the removal of sputum to try and prevent     these complications. Traditionally, a variety of approaches are usually combined including     inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise     secretions and improve sputum clearance.      There are many chest physiotherapy or airway clearance techniques (ACT) available including     breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic     Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest     Oscillation (the Vest), or oscillatory devices such as the Flutter or Acapella. When people     with CF have an infection or have severe disease often the effectiveness of ACTs can decrease     due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time     it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance     techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy.      At present no research studies have reported an increase in sputum cleared with the addition     of positive pressure, however it is thought that the ability to take a deeper breath when     using positive pressure would help to improve sputum clearance. With clinical experience of     the use of NIV with adult CF patients, the investigators aim to explore this objectively in     this study.      Research Question:      Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive     pressure to normal airway clearance techniques improve sputum clearance in stable adult     patients with cystic fibrosis?      Hypothesis      The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance     technique will lead to improvements in subjective ease of clearance and work of breathing     during airway clearance and objectively increase sputum clearance, as well as being well     tolerated in patients as an adjunct to airway clearance.   "
106992|NCT01885624|"     The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08     after single i.v. infusion to the adult healthy volunteers. Additionally were assessed     infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v.     infusion and to explore TAB mechanism-of-action biomarkers.   "
107336|NCT01881126|"     This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%)     alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS     0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering     therapy.   "
106997|NCT01885559|"     The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the     progression of cystic disease and on the decline in renal function in autosomal dominant     kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical     trials targeting different levels of kidney function: 1) early disease defined by GFR >60     mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73     m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the     first three years. Participants enrolled in Study B will be followed for five-to-eight years,     with the average length of follow-up being six and a half years.      Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an     angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.   "
106998|NCT01885546|"     This enhanced meter feature raises awareness among patients by providing additional     information regarding their glycemic control between Healthcare Professional visits. This     information may facilitate increased dialogue between patient and Healthcare Professionals     and can remind patients of the importance of glycemic control.      This study will evaluate a user's ability to obtain the enhanced meter feature.   "
106999|NCT01885533|"     Thyroid dysfunction following radioiodine for Graves' disease is common, potentially     detrimental and avoidable. A variety of clinical strategies are employed in the     post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen,     which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early     thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of     these is most effective in avoiding dysthyroidism, is unknown. This study aims to address     this lack of evidence. It will focus on Graves' disease as this is the commonest cause of     thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into     potential strategies for improving important clinical outcomes.   "
107000|NCT01885520|"     The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone     HCl SR tablet   "
107001|NCT01885507|"     Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end     expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic     approach to extubation may decrease the rate of extubation failure and enhance outcomes of     brain-injured patients.      We hypothesized that medical education and implementation of an evidence-base care bundle     associating protective ventilation and systemic approach to extubation can reduce the     duration of mechanical ventilation in brain-injured patients.   "
107002|NCT01885494|"     AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been     applied during AFF008 with regard to safety as well as immunological-, radiological and     clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied.     Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at     the occasion of 4 quarterly visits. This is offered to patients who received PD01A     vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will     ensure standardized and controlled management of individuals who have received PD01A as part     of AFF008, the Phase I study analyzing for the first time in humans this first in class     candidate.   "
107003|NCT01885481|"     Particle steroid drug such as triamcinolone has been used widely for epidural steroid     injection (ESI) treatment in Korea. However, Korea FDA recently prohibit ESI using     triamcinolone, following the regulation of US FDA. Therefore, dexamethasone and betamethasone     become only candidate drugs for ESI in Korea and the investigators are curious about the     effectiveness and safety of both drugs due to limitation of information about comparison of     two drugs in previous literature. So, this study aims to compare the effectiveness and safety     of both drugs and our hypothesis is that there is no difference of the effectiveness between     dexamethasone and betamethasone at 2 weeks after ESI.   "
107004|NCT01885468|"     This study is to verify the use of a hand held tool to verify the new setting of a     hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's     head, which is how settings are verified currently.   "
107005|NCT01885455|"     This is a randomized, interventional trial in which the navigation is the intervention. Phase     is not applicable. The study is a randomized trial to evaluate the impact of a nurse-led     patient navigation intervention in improving rates of receipt of lung-directed therapy with     curative intent (LDTCI) among African Americans with early stage lung cancer. Study sites are     cluster-randomized to either the usual care study arm or the to the navigation intervention     study arm. Randomization occurred at the level of the study site rather than at the level of     individual participants. There are two arms.   "
107017|NCT01885299|"     The RSSearch® Registry is an international multi-year database designed to track SRS/SBRT     (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) utilization, treatment     practices and outcomes to help determine, over time, the most effective use of these systems     in management of patients with life threatening tumors and other diseases. (This study was     formally called ReCKord and included the CyberKnife only; The ReCKord study continues as a     CyberKnife subset of RSSearch.)   "
107006|NCT01885442|"     Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need     advanced life-support. Survivors of critical illness are very vulnerable to weakness and     disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long     as 5 years after ICU discharge. In-bed cycling employs special equipment that attaches to a     patient's hospital bed, allowing them gentle leg exercise while in the ICU. The investigators     will offer patients in-bed cycling while they are needing a breathing machine, to help them     recover from weakness as fast as possible. Before doing a larger trial testing if in-bed     cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the     investigators do it?) are needed.      Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill     patients who need breathing machines.      Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to     survive their ICU stay are eligible. Specially trained physiotherapists will provide patients     with 30 minutes of in-bed cycling each day while they are in the ICU.      Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of     patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility:     whether patients can cycle on most days of their ICU stay, whether patients and their     families agree to be a part of the study, and whether the investigators can assess patients'     strength in the ICU and at hospital discharge.      Relevance: As the Canadian population ages, the demand for breathing machines during acute     illness will increase dramatically. Effective methods of physiotherapy are needed for     critically ill patients to minimize muscle weakness, speed recovery, and improve quality of     life. This pilot study is the first of several future larger studies about in-bed cycling in     the ICU. This program of research will help patients needing life support to regain their     strength and recover as fast as possible from critical illness.   "
107034|NCT01885078|"     The purpose of this study is to investigate the long-term safety and any side effects of     baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis     study.      The study provides for 5 years of additional treatment with baricitinib.   "
107007|NCT01885429|"     Muscle mass is normally maintained through the regulated balance between the processes of     protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old     muscle proteins). Proteins are composed of amino acids and we know that amino acids increase     muscle protein synthesis. However, not all amino acids are the same. Essential amino acids     are ones that must be consumed through food, while non-essential amino acids can be made by     our body. Interestingly, the essential amino acids are all that are required to increase the     rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to be     particularly important in regulating protein synthesis. However, how leucine is able to     increase protein synthesis is not entirely understood. Previously, it has been shown that     20-25 g of high-quality protein, such as that found in milk (whey), appears to be the amount     of protein that maximizes the rate of muscle protein synthesis after performing a bout of     resistance exercise. Thus, we aim to measure the synthesis of new muscle proteins after     ingesting different amounts of protein and amino acids. We will measure muscle protein     synthesis after consumption of the beverage a participant is randomized to in a leg that has     done no exercise ( ie. a rested leg) and in the other leg that has done resistance exercise.     Amino acids are 'strung-together' to make protein. The 'essential' amino acids must be     consumed through food because our body cannot make them, thus they are consumed when you eat     protein rich foods like milk or chicken. Leucine, isoleucine, and valine are simply 3 of the     8 essential amino acids that make up dietary protein. Unlike essential amino acids,     'non-essential' amino acids may be synthesized by the body, however they are also present in     protein rich foods like chicken or milk. We aim to determine if it is the leucine content     found in 25 g of whey protein that is primarily responsible for maximizing muscle protein     synthesis at rest and following resistance exercise. We also wish to determine how muscle     genes and metabolism respond to this protocol.   "
107008|NCT01885416|"     The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic     response to the ingestion of three different meals in obese subjects. The administered meals     will differ in the proportion of dairy products. Postprandial response will be monitored     during 6 hours after meal consumption.   "
107009|NCT01885403|"     The aim of the study is to determine the feasibility of collecting respiratory parameters     during recompensation following ADHF (Acute Decompensated Heart Failure)with non-invasive     measurements. This could lead to a better understanding of how respiratory parameters may     change during re-compensation therapy and could also be a comfortable method for patients.   "
107010|NCT01885390|"     The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in     patients with treatment-resistant or uncontrolled hypertension.   "
107011|NCT01885377|"     Objective: A randomized clinical trial in order to evaluate the efficacy of a specific     exercise strategy for patients with subacromial pain.      Hypothesis:      H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder     function and/or shoulder pain.      H0 - No difference between the two exercise strategies (specific exercise strategy and active     control exercises).      Method: Patients attending primary care with subacromial pain are offered participation. If     accepted, they will participate in a three month rehabilitation program. The duration of     symptoms can vary from 2 weeks and longer. The patients will be randomized to either     rehabilitation; the specific exercise strategy or active control exercises. All patients has     an equal number of sessions with the physical therapist (PT) to offer similar attention and     support with exercise performance. A blinded physical therapist evaluates the following     outcomes at baseline and after three-, six and twelve months:      Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes;     Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by     Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient     Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave     and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound     to reveal the status of the rotator cuff.      Additional to the analysis of treatment effect on shoulder function and pain, factors     influencing and explaining the CM-score at follow-ups will be analyzed.      This study is warranted in order to evaluate if an earlier reported positive effect on     shoulder function and pain with the specific exercise strategy, in patients on waiting list     for subacromial decompression, can be repeated in the primary care population of patients     with subacromial pain. There is no consensus about first-line exercises for patients with     subacromial pain, and these positive results on pain and shoulder function need to be     reproduced in primary care before they can be recommended and implemented. Further, knowledge     about which factors that can be used in prediction rules for patients that will respond to     the exercises or needs surgery is lacking.   "
107012|NCT01885364|"     Pain on injection of propofol is a common side effect. The present study was designed to     investigate the effect of esmolol on pain on propofol injection and to compare it with     remifentanil and placebo.   "
107013|NCT01885351|"     This study involves 3 phases that modifies current Interactive Preventative Health     Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual     colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific     barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to     assess their CRCS test preferences and corresponding test-specific barriers in real time.     Based on patient characteristics (e.g. age, personal and family history, physician CRCS     recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos     will appear in the pop-up screens to address/reduce the top patient-reported, test-specific     CRCS barriers while incorporating an action plan for CRCS adherence. The investigators     hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS     knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.   "
107014|NCT01885338|"     This study will evaluate the effect of the dietary supplement N-acetylcysteine (NAC) on     electrophysiologic (EEG) markers related to cognition, as well as performance on     psychological tests measuring cognition. The primary hypothesis is that participants treated     with NAC will show improvements in cognitive function, as measured by EEG and     performance-based tests.   "
107015|NCT01885325|"     The study addresses a critical public health problem, childhood obesity, by testing a     physical activity intervention in the types of preschools that millions of children attend.     Information gained in this study may lead to adoption of preschool policies and instructional     practices that increase physical activity and reduce the risk of obesity in preschool     children.   "
107016|NCT01885312|"     This study is designed to develop and test a tailored adaptive text messaging/short message     service (SMS) intervention for individuals interested in stopping or reducing their alcohol     consumption; and test and compare it to tailored but static, once a day messaging, gain     framed messaging, and ecological momentary assessment only.   "
107031|NCT01885117|"     The present study is designed to confirm the safety and immunogenicity of trivalent, surface     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and     the antibody response to each influenza vaccine antigen, as measured by Single Radial     Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post     immunization.      The vaccine composition will be based on the World Health Organization (WHO) recommended     influenza strains for the 2013/2014 Northern Hemisphere vaccine.      The results of this study are intended to support the use of this vaccine in future influenza     seasons if the recommended vaccine composition remains the same, in compliance with the     requirements of the current European Union (EU) recommendations for clinical trials related     to yearly licensing of influenza vaccines.   "
107032|NCT01885104|"     The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG     3350 solution concentrate to oral ingestion of a placebo solution concentrate, in     participants with constipation.   "
126759|NCT01625897|"     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy     of MP-214 in patients with chronic phase or elderly schizophrenia.   "
107019|NCT01885273|"     The study is to examine the effectiveness of cleansing wound with pressurized irrigation     method compared with conventional practice of swabbing on the wound healing and infection of     acute and chronic wound, and to evaluate the patient's physical symptoms related to wound,     patient's satisfaction to cleansing method, and cost of materials used between the two     groups.      Patients with acute or chronic non-sutured wounds as well as being eligible to exclusion     criteria will be recruited and randomly assigned to be cleansed using either: pressurized     irrigation method (experimental group) or swabbing method (control group).      244 patients will be recruited in the study. This will take place in four community health     centres run by the Hospital Authority in Hong Kong. The wounds of participants will be     cleansed using the assigned method for a six week period. The clinic staff nurse is     responsible for the ongoing assessment of the wound.      Wound assessment will be undertaken at enrolment and upon healing of the wound or at the end     of six-week period if the wounds have not healed. Demographic data and information related to     the wound -wound size +/- wound volume, wound culture swab, and symptoms -wound discomfort,     pain and odour will be collected at enrolment. Information related to the wound and     subjective measures of patient satisfaction -feeling of cleanliness, liking, and of staff     satisfaction -feeling user-friendliness, accessibility, cleanliness, liking to the cleansing     method using VAS will be assessed at completion of treatment. A list of cost measurements for     the wound cleansing would also be captured.   "
107020|NCT01885260|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx     in combination with metformin versus placebo + metformin   "
107021|NCT01885247|"     The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a     progression of therapeutic options and on a sensitization to physical activity.      For these patients selected on OCBP stage 2, the treatment options include Long Acting     Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic     (LAMA) or both (LAMA+LABA).      The purpose of this study is to observe in common clinical practice the benefit of physical     activity on quality of life, dyspnoea and walking distance for these patients under treatment     (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA)     benefit from physical activity.   "
107022|NCT01885234|"     The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in     pregnant women with gestational diabetes or chronic hypertension after an aerobic training in     cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks'     pregnant.      Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will     perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes     each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each)     will perform an unique session/week of relaxation and stretching.      Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the     newborn.   "
107023|NCT01885221|"     In an earlier study, the investigators developed a guidebook that taught women supportive     behaviors to help their husbands/partners quit smokeless tobacco. This study will create a     website using the information in the guidebook, along with interactive features, videos, and     forums. The investigators will then conduct a randomized trial comparing an intervention     group (receiving website access and the printed guidebook) with a delayed treatment control     condition, to learn if the support intervention can effectively teach women supportive     behaviors and thereby increase their partners' smokeless tobacco cessation rates.   "
107024|NCT01885208|"     This trial is conducted in Europe and North and South America. The aim of the trial is to     investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended     release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with     type 2 diabetes.   "
107025|NCT01885195|"     The purpose of this signal seeking study is to determine whether treatment with MEK162     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic     malignancies to warrant further study   "
107026|NCT01885182|"     To Determine the Safety and Efficacy of Oxycodone / Naloxone Prolonged Release Tablets     compared to Oxycodone PR in Subjects with Moderate to Severe, Chronic Cancer Pain   "
107027|NCT01885169|"     Influenza (the flu) is one of the most common respiratory viruses associated with     respiratory deteriorations in children and adolescents with cystic fibrosis. These     deteriorations usually mean antibiotics, hospitalizations, and worsening of pulmonary     function tests. A new flu vaccine has been recently approved for use in Canada (Flumist®).     What is particular about this flu vaccine is that it is a spray in the nose, which mimics how     influenza usually infects us. This particular vaccine protects children and adolescents much     better than the regular injectable flu shot.      This new vaccine has been given to > 2,000 healthy children and to >2,000 children with     asthma and well tolerated. The investigators want to know if Flumist® is well tolerated in     children with CF and does not cause worsening of respiratory symptoms. The investigators will     conduct a study where all participants will receive Flumist® in the nose. This study is     particularly important because its results will provide safety information on a vaccine that     is more efficacious for a population who needs safe and easy to administer protection against     the flu.   "
107028|NCT01885156|"     To see how well Naftin 1% cream works when applied once daily to the affected area. The     results will be compared to those using a placebo cream, which is a cream with no active     ingredient. Safety will also be measured.   "
107029|NCT01885143|"     Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of     acceptable quality as defined in the relevant FDA guidance document before and after artifact     correction and in standard screening images. Lossy compression will also be evaluated to     demonstrate that images are of acceptable quality when lossy compression is enabled.   "
107030|NCT01885130|"     Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer     or irritant in certain individuals.   "
107041|NCT01884987|"     Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy     for cancers, and may have a devastating effect on the patient's quality of life (QOL).     However,CRN was once regarded as a progressive and irreversible disease, no standard therapy     has been suggested for CRN. In our clinical practice, we have used     monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully     reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.   "
107036|NCT01885052|"     Background:      - Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29     stop smoking. This is part of a larger online stop-smoking program by the National Cancer     Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks     of follow-up messages. Program participants will receive texts on their cell phones,     including tips, information, and motivational messages, and then fill out surveys.      Objectives:      - To study how well the QuitTXT program helps smokers ages 18 29 stop smoking.      Eligibility:      - Adults ages 18 29 who have smoked on at least 5 of the past 30 days and who want to stop     smoking in the next 30 days.      Design:        -  Participants will receive a certain number of text messages during the 8-week study.          They will receive between 0 to 5 messages per day (or up to a total of 130 messages).        -  Participants will first fill out a survey about their smoking and quitting experiences.          Then they will choose a date to quit smoking (a quit date ) between 2 and 3 weeks after          this survey.        -  Participants will take four other surveys online, one during the program and three more          after they ve completed the program. Each survey will take about 10 20 minutes and asks          about their smoking habits and views on smoking and quitting. Each survey will be sent          by email, with reminders sent by email or telephone.        -  Participants will receive an iTunes or Amazon gift card for completing each survey          honestly.   "
107037|NCT01885039|"     Background:      - The Chinese University of Hong Kong and the National Cancer Institute are conducting a     breast tissue study in connection with another study on breast health. This larger study will     look at breast health in women who live in Hong Kong. Women in the breast health study will     provide a breast tissue sample during biopsy surgery. Researchers want to use part of the     sample to study changes in breast tissue that are related to breast diseases. This sample     study is part of the larger study.      Objectives:      - To look at changes in breast tissue that are related to breast diseases.      Eligibility:        -  Women who are participating in the Hong Kong breast health study.        -  Participants must be having a biopsy to remove breast tissue for study.      Design:        -  Participants will have a biopsy to remove a breast tissue sample. Most of the sample          will be used for diagnosis. A portion of the leftover tissue will be used for this          study.        -  No extra surgery will be required.        -  Treatment will not be provided as part of this study.   "
107038|NCT01885026|"     Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients     treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief     Internet intervention for problematic alcohol and drug use offers self-screening, in-depth     self-reporting, personalized feedback and treatment recommendations as well as an electronic     diary. Progress over time is shown in diagrams detailing consumption levels.      Method: This is a two-armed randomized controlled design, measuring outcomes in terms of     changes in problematic alcohol use up to one year after study recruitment. Participants with     problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use     (DUDIT > 1 for both men and women) are randomized into one of two groups: T1, eScreen     referral or Control group. Outcomes on alcohol and drug use as well as health-related     symptoms are assessed after 3, 6 and 12 months.      The hypothesis is that the group receiving the eScreen intervention will reduce their     alcohol/drug use to a larger extent than the control group at follow-up compared to the     baseline level.   "
107039|NCT01885013|"     This is a phase II comparative randomized clinical trial.      Eligible patients will be randomized (1:1) to:      Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide      Statistical Considerations:      In this randomized phase II study, the sample size was calculated basing on the primary     end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.      To find an advantage of 4 months of median time to progression (6 months in the control arm B     and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a     period of 24 months and will be considered further 12-month of follow-up. The primary     analysis of the study will be conducted in accordance with the intention to treat     principle, the secondary analysis will be conducted in the per protocol population.   "
107040|NCT01885000|"     The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of     patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The     feedback of patients receiving the active drug will be compared to the feedback of patients     receiving the placebo.   "
107082|NCT01884454|"     In view of the hormonal changes induced by both sleep deprivation and obstructive sleep apnea     syndrome (OSA), and the importance of maintaining these hormones in reproductive processes.     The present study aims to evaluate the effects of the OSA or sleep deprivation (total or     selective REM sleep for 48h) on reproductive function in adult men with normal body mass     index.   "
107042|NCT01884974|"     Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated     mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative     diseases (CMPD) associated with pulmonary hypertension were included in the group 5 category,     corresponding to PH for which the aetiology is unclear and/or multifactorial. CMPD include     chronic myelogenous leukaemia, chronic neutrophilic leukaemia and chronic eosinophilic     leukaemia (which primarily express a myeloid phenotype and polycythaemia vera), idiopathic     myelofibrosis, and essential thrombocytosis in which erythroid or megakaryocytic hyperplasia     predominates.      The purpose of this research:        1. Assess Prevalence of PH in patients with CMPD in Northern Israel        2. Describe the demographics and clinical course in patients with CMPD who are diagnosed          with PH.   "
107043|NCT01884961|"     Title: Radiotherapy as an immunological booster in patients with metastatic melanoma or renal     cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic     and therapeutic response      Phase: Proof of Principle phase II study      Study Design: Single center, open-label trial to assess the immune response and potential     biomarkers predictive of response      Study Duration:      Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up     every three months      Number of Subjects:      Mini-max two-stage Simon design:      • Step 1: 7 patients enrolled      If tumor antigen-specific immune response is observed in at least 3 patients:      • Step 2: recruitment of an additional 12 patients   "
107044|NCT01884948|"     To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing     postoperative morbidity and mortality after major liver resection.   "
107045|NCT01884935|"     The primary objective of the study is to determine the pharmacokinetic (PK) profile of     multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple     sclerosis (RRMS). The secondary objectives are as follows: to characterize the     pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to     explore the safety and tolerability of multiple doses of natalizumab in the pediatric     population.   "
107046|NCT01884922|"     Multicenter, open label, prospective study including successively a phase I trial and then a     phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both     drugs, vinblastine and nilotinib.   "
107047|NCT01884909|"     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,     balanced, single dose pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fed     condition in healthy adult human subjects.   "
107048|NCT01884896|"     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,     balanced, single dose pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fasting     condition in healthy adult human subjects.   "
107049|NCT01884883|"     The aim of this study is to confirm the biomechanical effects and evaluate functional     benefits of a new knee brace combining valgus inducing effect on medial compartment and leg     external rotation during the stance phase in patients with symptomatic medial knee     osteoarthritis.   "
107050|NCT01884870|"     Ureteral stones may be silent in 5.3% of patients. The goal of this study was to     prospectively evaluate the impact of a silent ureteral stone on renal function.   "
107051|NCT01884857|"     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,     balanced, single dose pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fasting     condition in healthy adult human subjects.   "
107052|NCT01884844|"     The purpose of this study is to whether vitamin d supplementation in those with low levels     may reduce depression symptoms in people experiencing bipolar depression.   "
107053|NCT01884831|"     In Russia the treatment nonhealing skin defects often limited to surgical interventions,     despite having developed modern methods of treatment of non-healing ulcers and other skin     imperfections. During the many years of research we have developed a skin equivalent     comprising living cells.      During pilot trial showed that the skin equivalent provides healing skin defect within 1-4     weeks in 95% of patients.   "
107054|NCT01884818|"     The study includes two phases. In phase one the reliability of thoracic spine mobility     measurements are studied in subjects with thoracic spine pain. In phase two the reliable     measurements are used to measure the effects of thoracic spine manipulation in subjects with     thoracic spine pain. The changes in pain is measured as well.      In second phase the control group receives TNS treatment six times at home as a placebo so     that the power of TNS is limited to very low level. The number of treatments are controlled     as well as the time of treatment. The treatment group receives six manipulation treatments     within 3 week period. The effects are measured immediately after the treatment weeks, and 3     and 8 week follow-up. Moreover the one year follow-up will be performed by mail     questionnaire.   "
107055|NCT01884805|"     The primary purpose of the protocol is to evaluate the adaptive optics visual simulator to     measure optical aberrations in hyperopic eyes.      The study hypotheses are the:        -  Ability to measure optical aberrations in hypermetropia.        -  Knowledge of optical aberrations of the eye hyperopic.        -  To adapt therapeutic management in optical aberrations measured.   "
107056|NCT01884792|"     The study is a crossover, pilot trial examining the acute effects of standing on blood sugar     in prediabetic, working adults. Participants will complete oral glucose tolerance testing,     once while sitting and once while standing. They will also wear a continuous blood sugar     monitor once while sitting at their desk for a week and once while using their desk as a     sit-stand desk with a goal of standing intermittently for at least half of the work day.     Physical activity levels will be measured with an accelerometer. The primary study hypothesis     is that blood sugar will differ between the sitting and standing conditions for each of the     tests performed.   "
107083|NCT01884441|"     Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a     higher response rate with the reduction of toxic side effects   "
107084|NCT01884428|"     study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV     (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order     to determine the recommended phase II dose   "
107057|NCT01884779|"     Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired     immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The     diagnosis of this disease requires invasives procedures, laboratory performance, and delays     up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and     Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and     urine samples that looks interesting in endemic areas, particularly in developing countries.     The study aims to measure the proportion of HIV-infected patients hospitalized or in     outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or     urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.   "
107058|NCT01884766|"     In many fields of medicine, except seizure disorders, blood biomarkers have captured an     integrated part of diagnostic decision making, including copeptin, the surrogate marker of     vasopressin release. There are strong arguments to hypothesize circulating copeptin is     elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and     that copeptin is predictive for complexity and relapse at least in FS. Although long-term     morbidity and mortality are both low in FS, there is high anxiety among parents because of a     lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by     adding important diagnostic and prognostic information. Eventually, less children may receive     needlessly over years fever drugs or anti-epileptic drugs.   "
107059|NCT01884753|"     The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D     ultrasound examinations, and to correlate the sonographic findings with urodynamic variables,     pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and     sexual dysfunction can be explored.   "
107060|NCT01884740|"     Central nervous system (CNS) malignancies are the second most common malignancy and the most     common solid tumor of childhood, including adolescence. Annually in the United States,     approximately 2,200 children are diagnosed with CNS malignancy and rates appear to be     increasing. CNS tumors are the leading cause of death from solid tumors in children. Survival     duration after diagnosis in children is highly variable depending in part on age at     diagnosis, location of tumor, and extent of resection; however, most children with high grade     glioma die within 3 years of diagnosis. All patients with high grade glioma experience a     recurrence after first-line therapy, so improvements in both first-line and salvage therapy     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently     used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in     previous phase I trials that a single Superselective Intra-arterial Cerebral Infusion (SIACI)     of Cetuximab and/or Bevacizumab is safe for the treatment of recurrent glioblastoma     multiforme (GBM) in adults, and we are currently evaluating the efficacy of this treatment.     Therefore, this phase I/II clinical research trial is an extension of that trial in that we     seek to test the hypothesis that intra-arterial Cetuximab and Bevacizumab is safe and     effective in the treatment of relapsed/refractory glioma in patients <22 years of age. We     expect that this project will provide important information regarding the utility of SIACI     Cetuximab and Bevacizumab therapy for malignant glioma in patients <22 years of age and may     alter the way these drugs are delivered to our patients in the near future.   "
107061|NCT01884727|"     To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis:     consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will     significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo     control (salt water, same dietary intake).   "
107062|NCT01884714|"     The purpose of this study is to better understand the genetic and metabolic differences in     obese individuals with and without type 2 diabetes. It is expected that this research will     help improve our understanding of the variability observed between obese and diabetic     individuals.   "
107063|NCT01884701|"     The current study is a prospective, single-arm, non-randomized, multi-center study to     evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions     during endovascular intervention for femoral-popliteal occlusive disease.   "
107064|NCT01884688|"     The purpose of this study is to determine the safety and in vivo persistence and expansion of     autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.   "
107065|NCT01884675|"     It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic     thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed     treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel     group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg)     versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to     assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.   "
107066|NCT01884662|"     Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of     the most problematic of secondary conditions that is minimally to modestly responsive to     currently available treatments. It is usually described as burning or stabbing, and is     located at or below the level at which their sensation changes from normal to impaired;     persons with no feeling at all in their legs for example can experience pain in the legs. The     purpose of this project is to further investigate the use of a novel visual stimulation     treatment; a technique that has shown benefit in other populations with chronic pain     secondary to deafferentation. To accomplish this, a novel treatment - virtual reality (VR)     walking - will be examined. Should this treatment show benefit, a portable, accessible means     of treatment will be available for persons with SCI and for whom transportation to health     care providers is often difficult.   "
107067|NCT01884649|"     Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical     inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this     study, we hypothesised that the serum fetuin A levels could be found to be low due to     inflammation in patients with Hashimoto thyroiditis   "
107068|NCT01884636|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole     will be assessed alone and in combination with methotrexate.   "
107069|NCT01884623|"     To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first     line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC.     Efficacy assessed by failure free survival   "
107070|NCT01884610|"     Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising     donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose     of recipient stem cell transplantation. The principal objective of the research is to study     any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood     stem cell donors.      The study subjects will be Retrospective and Prospective voluntary unrelated donors on the     Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University     College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free     Hospital and BUPA Glen Vale in Bristol.      All participants in the Prospective Arm will be asked to donate one 5−10ml sample of blood at     study entry prior to stem cell donation and further samples at 120 and 360 days post     donation. Those found to carry aneuploid cell clones at these time points will be asked for a     further 5−10ml blood sample at least twice − at the end of 24 months and 36 months     respectively. The Retrospective and Positive Control group will be asked to supply one 5−10ml     sample of blood.   "
107071|NCT01884597|"     This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal     choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.   "
107172|NCT01883271|"     Study objectives:        1. To compare cardiovascular function in older compared to young healthy adults.        2. To compare the effect of 8 weeks of aerobic interval training vs. continuous moderate          exercise on cardiovascular function in healthy older adults.      Hypotheses:        1. Compared to young adults, older adults will have lower cardiovascular function.        2. Compared to continuous moderate intensity exercise training, interval training will be          more effective in improving cardiovascular function in older adults.   "
107072|NCT01884584|"     The surgeon may remove a very small amount of additional tissue compared to what would be     removed if you were not enrolled in the study. This tissue may prove to contain tumor or it     may contain normal tissue. The surgical cavity will be examined by a special laser pen after     the tumor is removed, and if areas of fluorescence are seen, that may indicate tumor cells     where the ICG dye collected are still remaining and the surgeon would then remove those.     After the tumor and the tissue around it are removed and sent to the laboratory, the tissue     may be examined using that same laser pen to see where the cancer cells are and compare that     to what the laboratory sees when it looks at the tumor and tissue with a microscope. It is     hoped that what the dye shows and what is seen with the microscope will be alike.   "
107073|NCT01884571|"     This is a multicenter, 15-month study evaluating the effect of immunosuppression treatment on     the rate of change on the ALS Functional Rating Scale (Revised) (ALSFRS-R) score in up to 33     subjects with Amyotrophic Lateral Sclerosis (ALS).   "
107074|NCT01884558|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole will     be assessed alone and in combination with metformin.   "
107075|NCT01884545|"     The purpose of this study is to examine whether the use of genetic test information and/or     health coaching in patient risk counseling for heart disease and diabetes affect health     behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents     and Air Force retiree patients.      Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned     to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information     (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health     coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected     for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk     markers. Participants in the two groups that include health coaching will be assigned to a     trained certified health coach for a period of 6 months. The duration of the study is 12     months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys     at 6 weeks and 3 month time points.   "
107076|NCT01884532|"     The purpose of this clinical study is to evaluate blood metal ion levels as a function of     time of implantation for the ASR-XL MoM system.   "
107077|NCT01884519|"     The purpose of this study is to assess, in adults 18 years of age and above, the     immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit SSW     2013/2014, containing the three vaccine influenza strains (two A strains and one B strain)     for the 2013/2014 season.   "
107078|NCT01884506|"     A total of 75 subjects will be recruited for this study (25 normal weight, 25 overweight, 25     obese). In each subject blood volume will be determined using the minimally invasive carbon     monoxide-rebreathing method (substudy 1) and iron absorption will be measured from a test     meal labeled with stable iron isotopes. The effect of ascorbic acid on iron absorption will     further be determined using a second labeled test meal (substudy 2). In addition,     inflammation, hepcidin and iron status will be determined. In order to study the effect of     body fat content on blood volume and iron absorption weight and height will be measured, and     body fat will de determined by dual energy X-ray absorptiometry.   "
107079|NCT01884493|"     The gait symptoms are usually refractory to the dopaminergic agents and some other     resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for     in this regard. To study the impact of rTMS, investigators will adopt a domestically     developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the     electroencephalographic and electromyographic signals for PD patients when walking in the     gait laboratory or when conducting leg dorsiflexion movement on sitting.   "
107080|NCT01884480|"     In Kidney transplant recipients Once daily Tacrolimus has the poteb]ntial advantage of better     adnerence, and perhpas improvement in reanl function compred with the twice daily tacrolimus     formulation.      Our center has the largest experience in North America with once-daily tacrolimus ( advagraf)     in Renal transplant recipients.      Recently we converted ~500 stable patients from the twice daily to once-daily tacrolimus.      We are interested in:        1. change in renal function        2. dose changes based on ethnic diveristy        3. dose changes based on pharmacogenetics      This will helpnus understand better ways to utilize this anti-rejection medication   "
107081|NCT01884467|"     Recurrent UTIs are common among patients on IC. These create significant patient morbidity     and healthcare burden. In desperation, many physicians prescribe prophylactic oral or     intravesical antibiotics. This practice is common among our Gillette clinic patients.     However, the benefit is unclear and the risks are not insignificant. As such, practice     variation is significant. In order to better define the evidence for or against gentamicin     bladder irrigation and thus inform clinical practice both locally at our Gillette urology     clinic and for practitioners at large we will pursue the following specific aims:        1. Compare rates of symptomatic urinary tract infection and asymptomatic bacteriuria among          a population of Gillette patients on IC with and without gentamicin bladder          instillation.        2. Compare antibiotic resistance rates among a population of Gillette patients on IC with          and without gentamicin bladder instillation.   "
107101|NCT01884207|"     Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to     differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of the     orbit will be performed including standard morphological sequences and advanced sequence     techniques. These advanced sequence techniques may allow to differentiate benign from     malignant tumors based on their cellularity and vascularity (diffusion and perfusion     imaging). These MRI data will be analysed and the level of diffusion and perfusion will be     measured and compared to the histological findings. Cut-off values of diffusion and perfusion     will be calculated that allow to separate benign from malignant tumors.   "
107102|NCT01884194|"     MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients   "
107194|NCT01882985|"     This phase II trial is studying how well giving docetaxel together with lycopene works in     treating patients with hormone-resistant prostate cancer not previously treated with     chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from forming.     Giving docetaxel together with lycopene may be an effective treatment for prostate cancer.   "
107087|NCT01884389|"     This study is testing a navigation program for early palliative care provided in tandem with     HIV primary care for persons living with HIV (PLWH) who are at high risk or mortality and     morbidity related to their co-morbid chronic conditions. Participants are enrolled for a     period of 36 months, with data collection at enrollment and every 9 months after, for a total     of 5 data collection time points. Study participants enrolled will be randomized into one of     two groups: control or intervention. Control group participants will receive control calls in     between survey data collection time points. Intervention group participants will participate     in a Navigation Program which includes home visits and phone calls with an advanced practice     nurse (APN) and licensed social worker (LSW), as well as visits / calls by a volunteer if     desired. The frequency of visits / calls will be determined based on level of need (high,     medium or low).      The specific aims of the study are to: 1) identify needs and preferences for palliative care     and advance care planning for PLWH, in order to tailor an existing Navigation Program for     this study; 2) test the effectiveness of an HIV Navigation Program intervention on outcomes     of quality of life, symptom burden, coping ability, and advance care planning; and 3)     determine if effectiveness of the HIV Navigation Program intervention differs by age, gender,     ethnicity, education, income level, and level of palliative care service need.   "
107088|NCT01884376|"     The aim of this study is the development and initial clinical application of the nerve guide     Neuromaix in humans to provide evidence for the safety and performance of the device.      Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve     discontinuity, and to create a conduit for axonal growth across the nerve gap.   "
107089|NCT01884363|"     This study will examine whether a twelve-week intervention with one ounce (28 g) per day of     walnuts improves endothelial function measured non-invasively using finger probe     (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.   "
107090|NCT01884350|"     The study purpose is to assess the impact of an educational program on patient adherence in     patients taking Apixaban for SPAF at 24 weeks   "
107091|NCT01884337|"     The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of     Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip     replacement   "
107092|NCT01884324|"     Primary objective: to test the hypothesis that elective early delivery will protect the fetal     bowel from the deleterious intrauterine factors late in the pregnancy and will be associated     with improved neonatal outcomes.      Secondary objective: to introduce a standardized diagnostic, monitoring, and postnatal     surgical management of infants with gastroschisis.   "
107093|NCT01884311|"     The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF.     The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment     coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin     (IGIV) therapy.   "
107094|NCT01884298|"     In General anesthesia, two main ways of pain control are used intra-operatively, one is     opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is     potent and more effective , and also the benefits of stress block, less depression of breath.     however, the epidural technique often causes more drop of blood pressure, especially in     dehydrated patients. The investigators designed the trial to see if the benefit weigh out the     potential risk of epidural in isolated hypertensive patients.   "
107095|NCT01884285|"     This is a phase I, open-label, multicentre study of AZD8186 administered orally in patients     with advanced castrate-resistant prostate cancer (CRPC), squamous non-small cell lung cancer     (sqNSCLC), triple negative breast cancer (TNBC) and known PTEN-deficient/mutated or PIK3CB     mutated/amplified advanced solid malignancies as monotherapy and in combination with     abiraterone acetate or AZD2014.   "
107096|NCT01884272|"     This is a drug-drug interaction study in healthy volunteers to evaluate the potential     pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and     leinurad on the non-steroidal anti-inflammatory drugs.   "
107097|NCT01884259|"     This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel,     cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.   "
107098|NCT01884246|"     Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue     of having high rates of multiple CVD risk factors. There is a critical need to develop and     test CVD risk reducing interventions that are appropriate and effective in Appalachia. In the     absence of such interventions, the dramatic CVD disparities seen in this area will continue     to rise.      Lifestyle interventions reduce CVD risk by 44%. The investigators and others have     demonstrated that lifestyle change is most effective when patients are given the tools to     engage in effective self-care, and that interventions individualized to patients' specific     needs and barriers are more effective than interventions that are not. The central hypothesis     is that to be successful in Appalachia, CVD risk reducing interventions must focus on     patient-centered lifestyle change that increase individuals' abilities to engage in     self-care, must be culturally appropriate, and must have components that overcome barriers     faced by individuals living in Appalachia.      The investigators propose a randomized, controlled comparative effectiveness trial with 300     individuals from Appalachian Kentucky who do not have a primary care provider and who are at     risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators     will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction     intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming     barriers to success with (2) referral of patients to a primary care provider for management     of their CVD risk factors. The investigators propose the following specific aims to be tested     at 4 months and 1 year after baseline. To compare the short and long-term impact of the     interventions on:      1) the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile,     hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive     symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3)     quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and     adoptability by assessing adherence to recommended CVD risk reduction measures, and retention     of recruited individuals. The investigators hypothesize that in comparison to the referral     strategy, the multifaceted patient-centered, self-care intervention will engender more     favorable outcomes across all measures.   "
107099|NCT01884233|"     The objective of the current research is to improve treatment for injection opioid users by     augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse     prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.   "
107100|NCT01884220|"     The purpose of this study are: to characterize and understand the natural history of disease     progression in WD and CESD, and to provide historical controls for WD and CESD for developing     clinical treatment trials. The hypothesis is that the variability and clinical progression in     WD and CESD is large and represents a continuum of severities from a lethal infantile to near     normal adults with only fatty livers.   "
107337|NCT01881113|"     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in     the conjunctival allergen challenge (CAC) model.   "
107103|NCT01884181|"     The hypotheses of the project are        1. Diffusion MRI using compressed sensing could have reduced motion sensitivity and          improved susceptibility related artifact because of accelerated acquisition.        2. The macromolecule deposition in the brain of patients with Huntington Disease (HD) can          lead to changes detectible by diffusion MRI.      To validate the hypothesis that the new accelerated diffusion MRI technique could produce a     new biomarker for HD, patients with Huntington Disease will be recruited. The diffusion index     will be calculated using accelerated acquisition. The diagnostic performance will be     evaluated for data reconstructed with and without acceleration. The correlation with the     disease severity will be assessed.   "
107104|NCT01884168|"     To investigate gene expression profile and immunological associated analysis relating to     immunotherapy response of patients with malignant tumor presenting malignant cavity effusion     after DC-CIK immunotherapy.   "
107105|NCT01884155|"     This open label trial is conducted to investigate the efficacy and safety of allogeneic     umbilical cord blood (UCB) therapy for patients with stroke.   "
107106|NCT01884142|"     The investigators hypothesize that exercise training would improve the mechanoreflex and     metaboreflex control in heart failure patients.   "
107107|NCT01884129|"     We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on     CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.   "
107108|NCT01884116|"     Myofascial pain syndrome (MPS) is a common clinical problem of musculoskeletal pain and     various treatment modalities have been introduced. If self-applicable physical modalities and     medications that are used for treatment of MPS patients are combined, they may open up new     possibilities for effective and practical self-care. The aim of this study is to compared the     therapeutic effect of non-steroidal anti-inflammatory drug (NSAID) patch given in monotherapy     and NSAID patch in combination with transcutaneous electric nerve stimulation, heating pad,     or topical capsaicin in the treatment of patients with MPS of the upper trapezius.   "
107109|NCT01884103|"     Our overall goal in this proposed study is to describe the current prehospital trauma triage     process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to     identify the effect of certain medications (anticoagulants and platelet inhibitors) on     TBI-related need for trauma center services, and to identify novel TBI screening strategies     that are feasible for use in the prehospital setting.   "
107110|NCT01884090|"     The Youth Empowerment Solutions for Positive Youth Development (YES) Study , is a randomized     controlled trial that compares youth in standard after school programs offering activity     choice (e.g. sports, academic enrichment, arts) to youth assigned to an after school program     that includes training in community development, formation of intergenerational partnerships     and experience conducting community improvement projects. The study aims are to: 1) implement     and evaluate an empirically developed intervention for empowering youth (YES) using a     randomized controlled trial design in a high risk urban and suburban sample; 2) test a     conceptual model that posits a causal relationship from youth empowerment processes to     positive developmental outcomes; and 3) follow youth over time to assess sustainability of     gains in healthy development. Developmental outcomes will be assessed at baseline, curriculum     completion and at three and nine months post-intervention.      This study will be referred to as the Genesee County Afterschool Study (GCAS) in recruitment,     consents, assents and promotional materials. The study compares different types of after     school programs, and we will be randomly assigning students into two groups, 1) the regular     21st Century Afterschool programs and 2) the regular 21st Century Afterschool programs with     the YES supplement. We do not want to bias desirability of the random groups by naming one of     the groups to be tested in the study name. Therefore, in documents we will refer to the study     as the Genesee County Afterschool Study (GCAS).      Study hypotheses:        1. Youth in the YES intervention arm will demonstrate increased intrapersonal,          interactional, and behavioral empowerment than youth in the comparison group arm.        2. Youth in the YES intervention arm will demonstrate higher scores on the positive          developmental outcome variables, and lower scores on the negative developmental outcome          variables, than youth in the comparison group arm.        3. Behavioral empowerment will partially mediate the relations between intrapersonal and          interactional empowerment and youth developmental outcomes, such that youth with greater          intrapersonal and interactional empowerment skills will demonstrate increased behavioral          empowerment, which in turn will result in higher scores on positive developmental          outcome variables, and lower scores on negative developmental outcome variables.   "
107111|NCT01884077|"     Specific Aim: To compare early postoperative pain relief in patients over the age of 70 who     undergo either Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty in treatment of     glenohumeral osteoarthritis.      Hypothesis: Early postoperative pain relief will be greater in those undergoing Reverse     Shoulder Arthroplasty.   "
107112|NCT01884064|"     This study investigated the short term effects of repeated administrations of     repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate     neurophysiologic responses to rTMS of the activated motor system in patients with FHD.   "
107113|NCT01884051|"     Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which     underlie PAH will improve pulmonary vascular function and consequences of the disease.   "
107114|NCT01884038|"     Patients undergoing orthotopic liver transplant will experience some degree of clinical     and/or biochemical hepatic dysfunction. This early injury is known as primary graft     dysfunction and varies from minor abnormalities to primary nonfunction. Prostaglandin-class     drugs, including prostacyclin and its analogs, could represent an important advance toward     the goal of reducing transplant related morbidity, mortality and associated costs by     providing these benefits.   "
107115|NCT01884025|"     Individuals with serious mental illness have greater morbidity from physical illness and     mortality than the general population, but tend not to initiate or sustain engagement in     health promotion interventions. Although promising weight management and wellness     interventions have been developed for this population, they are very intensive and tend to     have low enrollment, high attrition, and low reach. This pilot study will investigate a novel     low-demand intervention that may be initially more acceptable, the Get Moving and Get Well!     (GMGW) program. The primary objectives of the proposed study are to investigate the effects     of participation in the GMGW program on measures of behavioral activation, self-efficacy,     physical activity, general physical and mental health, mood, participants' intent to engage     in more intensive physical health interventions, and actual engagement in those programs.     Results of this pilot study will inform a future full-scale study of GMGW.   "
107118|NCT01883986|"     The aims of this project are to assess the feasibility of recruiting patients and delivering     a nurse-led telephone based palliative care intervention for patients with newly diagnosed     lung cancer and to assess if among patients with newly diagnosed lung cancer, the     investigators can estimate the effect of a nurse-led telephone based palliative care     intervention on quality-of-life, symptom burden and patient satisfaction.   "
107228|NCT01882543|"     The primary objective of this study is to evaluate the effect of 6 weeks of treatment with     once daily administration of AQX-1125 compared to placebo on average daily pain in subjects     with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using     a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary   "
107119|NCT01883973|"     Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain     stimulation surgery in the awake patient using microelectrode recording to guide final     electrode placement. Microelectrode recording is a means of analyzing the electrical activity     of the brain, and assessing whether we have found the target for the deep brain stimulator     electrode. However, no evidence exists that microelectrode recording improves patient     outcomes. The use of microelectrode recording does extend the duration of surgery and there     is evidence to suggest that microelectrode recording may increase the risk of bleeding in the     brain during surgery.   "
107120|NCT01883960|"     The primary goal of this study is to establish and evaluate an image-based biomarker for the     impaired motor control and sensory information processing present in Cerebral palsy (CP) and     stroke patients.   "
107121|NCT01883947|"     The aim is to study effects of touch massage in the sub-acute phase after stroke in two main     areas; general health and independence.The hypothesis are that; touch massage in the     sub-acute phase after stroke decreases anxiety and pain, increases health related-quality of     life, decrease physiological stress responses, increase sensorimotor function, decrease     disability, and increase activity in sensorimotor areas and decrease redundant brain activity     in motor-related areas.   "
107122|NCT01883934|"     The purpose of this study is to improve patient understanding of and interest in donating     frozen embryos resulting from in vitro fertilization (IVF) to others undergoing infertility     treatment.   "
107123|NCT01883921|"     Primary:        -  Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using          infusion nurse and patient measured physical, quality of life (QOL), respiratory,          laboratory, and disability assessments in patients with Primary Immunodeficiency Disease          (PIDD).      Secondary:        -  Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured          outcomes.        -  Change in IVIg/SCIg dose timing effects measured outcomes.        -  Change in patient status is reflected in measured outcomes.        -  Assess the value to physicians from collected outcomes data.        -  Identify types of patients by response to IVIg/SCIg therapies (well maintained,          problematic, etc.).        -  Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease state,          co-morbidities, and demographics.   "
107124|NCT01883908|"     Patients are asked to be in this study if have oropharyngeal cancer and will be treated with     chemotherapy and radiation.      This research is being done to find out if acupuncture can reduce the mouth inflammation and     pain caused by chemotherapy and radiation. Chemoradiation may cause mouth inflammation and     pain.      Acupuncture is a medical technique of inserting very thin needles into the energy points on     the body with the aim to restore health and well-being. It has been used widely to treat     pain, such as lower back pain and joint pain. In this study we will assess the potential     usefulness of acupuncture to decrease the severity of mucositis and mucositis-related mouth     and throat pain in patients receiving chemoradiation for oropharyngeal cancer.      Mouth cancer patients receiving chemoradiation who have not had acupuncture within the last     one month and who do not have a history of head and neck cancer may join this pilot study.   "
107125|NCT01883895|"     The study involves recording response to discomfort following different forms of exercise. We     think that there will be a increased pain tolerance following exercise but are unsure if     there will be a difference between exercises.   "
107126|NCT01883882|"     The proposed research will develop, demonstrate the feasibility of, and pilot test in a     randomized controlled trial a prescription opioid taper support intervention. This     intervention aims to prevent opioid misuse and adverse events among patients receiving     chronic opioid therapy for chronic non-cancer pain without evidence of current substance     abuse.      The project will yield information essential to planning a future, larger-scale RCT designed     to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse,     misuse, overdose and other adverse events among patients receiving chronic opioid therapy for     chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related     activity interference, and mood. Participants in our pilot study will be limited to those     without current opioid abuse or other substance abuse, but past substance abuse will be     allowed. This will provide a sample of patients at risk for opioid abuse, misuse and     overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients     receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid     taper support intervention, as compared with patients randomized to usual opioid prescribing     care, will have lower opioid average daily doses at 22 and 34 weeks.   "
107127|NCT01883869|"     The hypothesis to be tested is that ticagrelor (Brilinta™) will reduce platelet activation     and markers of inflammation in patients with pneumonia.   "
107128|NCT01883856|"     The purpose of this study is to evaluate and compare the clinical outcomes after implantation     of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate     Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.   "
107135|NCT01883765|"     Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for     ADHD mainly in children and adolescents. However, randomized double-blind trials that include     a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of     NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to     monitor and exclude unspecific effects.      This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition     and a cognitive behavioral treatment in adults with persistent ADHD.      Efficacy is assessed on several outcome parameters, such as symptom severity,     neuropsychological variables (e.g., attention, memory), and EEG parameters.   "
107136|NCT01883752|"     The purpose of this study is to evaluate whether goal directed fluid management using     respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has     potential to decrease postoperative complications and outcomes.   "
148077|NCT01346046|"     The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of     subjects who have been diagnosed with Type 2 diabetes.   "
107301|NCT01881581|"     This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to     evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA)     HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who     have an HIV-1 RNA < 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.   "
107129|NCT01883843|"     Stroke is one of the major causes of disability in the Western world. Initially gait is the     most affected function, 80% of patients lose this ability.      Rehabilitation in stroke patients improves walking abilities in terms of gait and related     gait activities, though six months after stroke many patients are significantly disabled.      Recently, a prospective study of 205 stroke patients showed that approximately 21% of     patients have a significant decrease of mobility between the first and the third year after     stroke. The main finding showed that inactivity was the most important factor for the     mobility decline.      Evidence about effects of direct current brain stimulation on motor recovery function of     lower limb are still little, some show that quadriceps strength after stimulation of damaged     M1 area increased. Another study where tDCS was associated with robotic gait training did not     report any effect compared to treatment alone. It is necessary to define if a different     dosage of stimulation or the association of tDCS with gait training can improve walking and     if further studies are required to investigate their effectiveness.      The aim of this clinical trial is to test the possibility of gait improvement through the     association of tDCS with a specific task-oriented circuit training for walking abilities,     balance and mobility.   "
107130|NCT01883830|"     Traumatic brain injury is an extremely common disease, it counts 50.000 deaths and 235.000     hospitalizations every year. Functional consequences of an acquired brain injury have a     considerable impact on quality of lives of patients and care-givers with direct effects on     balance, mobility and on psycho-social functions. Attention deficits are one of the most     frequent and disabling consequences of severe brain injury. Within the wide spectrum of     attentive problems, patients with traumatic brain injury frequently have shown difficulties     in divided attention. Patients, care-givers and professionals frequently refer difficulties     also in selective attention and vigilance as consequence of the trauma. It has been shown how     these difficulties are tightly related with the missed return to work after two years from     the injury.      The hypothesis of this study is to investigate the feasibility of a rehabilitative protocol     on gaming using the console Xbox and its efficacy in improving balance, mobility, risk of     falling, attentive functions (selective and divided attention) in subjects which have had a     traumatic brain injury at least 12 months before.   "
107131|NCT01883817|"     The study hypothesis is that DHA is more effective than placebo in increasing brain     activation and reducing symptoms in psychostimulant-free children with ADHD.   "
107132|NCT01883804|"     Type 1 Diabetes is an autoimmune condition in which segments of the immune system cause the     destruction of insulin producing cells in the pancreas, leaving individuals with an impaired     ability to control blood glucose levels. Currently there is no cure for Type 1 Diabetes and     the treatments involve lifelong insulin administration and careful monitoring of blood     glucose levels. Long-term complications like cardiovascular disease, nerve damage, and retina     damage, may result. Previous studies have shown that improvement in the control of blood     glucose can reduce the risks from these long-term complications. Residual insulin production,     typically within the first few years following diagnosis, helps to reduce an individual's     need to supplement insulin by injection or pump. This effect helps in maintaining the body's     ability to regulate blood glucose levels and reducing the needs of external insulin.      Methyldopa, or Aldomet, has been approved by the Food and Drug Administration and is commonly     used to treat high blood pressure. This drug has been approved for several decades and has     been shown to be safe and effective. This drug has been identified by the researcher to be     able to block the communication between two important types of immune cells; which play a     critical role in the autoimmune processes of Type 1 Diabetes. The investigators hypothesize     that Methyldopa, over a 6 week treatment period, will block this communication and possibly     slow down the destruction of insulin producing cells. The investigators hope to assess the     appropriate and safe dose to achieve this effect, along with the drug's ability to maintain     insulin production and blood glucose control.   "
107133|NCT01883791|"     An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol     and/or drug use. One model of intervention that has been shown effective in medical settings     to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief     intervention, and referral to treatment (SBIRT). Despite the effectiveness of SBIRT for risky     alcohol use in medical settings, there has been no research on the effectiveness of SBIRT in     mental health treatment settings. Given the proportionately large number of mental health     patients who also engage in hazardous substance use, research is needed to find an     appropriate and effective substance use intervention for patients in these settings.      The proposed study uses a randomized controlled trial to examine the extent to which the     World Health Organization's SBIRT model, the ASSIST (Alcohol, Smoking, and Substance     Involvement Screening Test) and its associated brief behavioral intervention, leads to     reductions in substances prevalent in mental health settings: alcohol, cannabis and     stimulants (i.e., cocaine and methamphetamine). The study will also examine the effect of     SBIRT on improvement in psychiatric symptoms, improved quality of life and for those whose     level of substance misuse indicates a need for treatment, initiation and engagement into SUD     treatment services. Eligible participants will be mental health patients who report any past     year use of cannabis or stimulants or at least one heavy drinking day in the past year.     Mental health patients (N=750) who meet eligibility criteria will be enrolled and randomly     assigned to either the SBIRT intervention condition or to a health education attention     control condition. Participants will be assessed at baseline on substance use, psychiatric     symptoms and quality of life. Each participant will be assessed at 3-, 6- and 12- month     follow up points for alcohol and drug use, involvement in SUD treatment services, severity of     psychiatric symptoms and quality of life. If successful this study will yield valuable new     knowledge about the effectiveness of SBIRT in mental health treatment settings and will     promote improved well being of mental health patients. Further, the study will provide     evidence on the effectiveness of SBIRT for reducing illicit drug use. Results from this     research will be used as the basis for broader dissemination and of SBIRT in mental health     settings.   "
107134|NCT01883778|"     The purpose of this study is to identify existing cost knowledge of Emergency Medicine (EM)     physicians and patients and investigates its reported impacts on medical compliance. A     cross-sectional survey will be administered electronically to Emergency Medicine physicians     at the University of Utah Hospital and the Emergency Physician Integrated Care, LLC (EPIC)     who staff ten-community hospital Emergency Departments (ED) in order to investigate physician     knowledge and attitudes regarding cost and perceived patient compliance. In addition, a     cross-sectional survey will be administered to a convenience sample of patients presenting to     the University of Utah Emergency Department to obtain information about their cost knowledge     and reported compliance. All ED patients will complete a follow-up phone survey to measure     compliance with recommendations made during the ED visits. Following administration of the     baseline survey physicians will be provided the prices of the test and procedures and will be     re-surveyed 30-days later as a post intervention test to measure changes in knowledge and     attitudes.   "
107159|NCT01883440|"     Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey.     Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in     laboratory studies.      In the present study we aim to investigate if a nasal spray with glucose oxidase could treat     a common cold, when the treatment is started even after the onset of the symptoms. The study     is randomized and placebo controlled.   "
107137|NCT01883739|"     The investigators shall conduct a randomized controlled trial to investigate the effect of     parental presence at transfer rounds on parental anxiety and patient safety following     transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The     investigators plan to test the hypothesis that parental involvement in the child's transfer,     with the option of peer support, will result in measurable reductions in medication errors,     unplanned nutritional and feeding management, and parental anxiety after transfer as compared     to the control group. The investigators goal is to improve continuity of care by implementing     multidisciplinary transfer rounds at the child's bedside in which patients and family share     in the control of the management plan when a cardiac child is discharged from PCICU to the     ward.   "
107138|NCT01883726|"     Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang     Gung Memorial Hospital. The objective of this study is to compare the number of clinical     visits, total prices, complications and nasal symmetry between these two NAM reconstruction     methods.   "
107139|NCT01883713|"     Acute and chronic anemia continue to be associated with increased mortality in a number of     clinical settings, including cardiac and non-cardiac surgery. However, We have no clinical     measures that let us know of impending insufficient oxygenation as anemia progresses (R.B.     Weiskopf). The current proposal is based on experimental and clinical data which suggest that     plasma methemoglobin (MetHb) may be a sensitive biomarker of tissue hypoxia and anemic     stress in surgical patients.      Hypothesis: Increased methemoglobin is a biomarker of tissue hypoxia during acute anemia.      Primary Objective: To demonstrate a direct relationship between decreased Hb and increased     MetHb in patients undergoing acute hemodilution on cardiopulmonary bypass (CPB).   "
107140|NCT01883700|"     This study examines the effects of carbohydrate type (high- or low-Glycemic Index (GI)) and     amount (high- or low-Glycemic Load (GL)) have on blood glucose levels, blood pressure and     arterial stiffness in healthy individuals. It will also determine whether subjective ratings     such as test meal palatability and hunger are related to changes in blood glucose. The     investigators hypothesize that: (1) High-GI meals, regardless of GL, will increase arterial     stiffness; low-GI meals, regardless of GL, will have a neutral or lowering effect on arterial     stiffness (augmentation index). (2) High-GI meals, regardless of GL, will have an elevating     effect on both central and peripheral blood pressures. (3) The incremental area under the     curve for blood glucose will show most significant differences between high-GI, high-GL and     low-GI, low-GL meals at 30 and 90 min.   "
107141|NCT01883687|"     Objectives: The aims of this study are (1) to define the effectiveness of functional nasal     surgery during Le Fort I osteotomy on nasal obstruction through objective as well as     subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery     with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal     surgery may reduce nasal obstruction severity.      Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial Center     and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients with     unilateral cleft lip and palate and dentofacial deformity (age >16 for females, >18 for     males; 40 in experimental and 40 in control groups) Interventions: In the experimental group,     all patients will receive Le Fort I osteotomy and septoplasty. In the control group, all     patients will receive Le Fort I osteotomy only.      Measurements: All patients will undergo history taking, clinical examination,     radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image     examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce     radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and     24 months after surgery.      Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated     measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for a     p value of less than 0.05.      Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty,     effectiveness   "
107142|NCT01883674|"     This project evaluates the use of different types of proteins from various food sources after     an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have     low muscle mass). Specifically, researchers want to:        -  Examine the efficiency of protein intake after exercise on muscle mass and physical          abilities;        -  Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL          cholesterol, total cholesterol and triglycerides);        -  Examine the impact of exercise and proteins on liver enzymes;        -  Examine the impact of exercise and proteins on a hormone that controls hunger;        -  Evaluate the program's impact on the ability of the body to produce energy.      All participants are exercising (resistance training) and ingest one of the 3 different     sources of proteins, immediately after training:        -  Milk proteins (from milk beverage)        -  Essential amino acids (added to a soya beverage)        -  No protein (rice beverage - control group)      Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical     function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins     and EAA will be both superior to control group.      This would represent an interesting finding since milk is more accessible, palatable and     cheaper than essential amino acids commercial mix.   "
107143|NCT01883661|"     The aim of this study is to prove the BMMNC Therapy in Multiple sclerosis, and to control     symptoms and help to maintain a normal quality of life of suffering patients.   "
107144|NCT01883648|"     This is a randomized, cross over study to determine the efficacy of coconut oil in subjects     with mild to moderate Alzheimer's disease.   "
107145|NCT01883635|"     The purpose of the study is to see whether exercise can improve the health and well-being of     cancer survivors. We also want to know about the health and well being of caregivers.   "
107146|NCT01883622|"     Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of     glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are     available on glucose variability (GV) in pregnancy. The aim of this study was to assess GV in     normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes (GDM),     and its possible association with HbA1c.   "
107160|NCT01883427|"     To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper     respiratory tract infections in children beyond 4 years.   "
113313|NCT01802762|"     To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe     and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF);     cerebral blood volume (CBV)) obtained.   "
107147|NCT01883609|"     This is a clinical trial in which healthy volunteers will be administered experimental     malaria vaccines. One group of volunteers will receive vaccination with the leading malaria     vaccine candidate, RTS,S/AS01. This vaccine schedule will consist of 3 doses of RTS,S/AS01     with an interval of 4 weeks between doses (Doses given at 0,4 and 8 week timepoints). Another     group will receive a vaccination schedule composed of the same dosage and timing regimen of     RTS,S, but they will also receive vaccination with ChAd63 ME-TRAP, 2 weeks after the first     RTS,S followed 8 weeks later by vaccination with MVA ME-TRAP (2 and 10 week timepoints).      The study will assess the safety of the vaccinations, and the immune responses to     vaccination. Immune responses are measured by tests on blood samples. Volunteers will be     infected with malaria by mosquito bites, 12 weeks after the first vaccination. In addition, a     group of volunteers not receiving vaccines will also be infected with malaria by the same     method. These infection experiments will be used to assess vaccine efficacy: how well the     vaccines act to prevent malaria disease. A further single volunteer may also be infected with     malaria; this volunteer participated in a previous trial where they received vaccines and was     completely protected against malaria disease after infection by mosquito bite.      The RTS,S/AS01 vaccine is a protein (RTS,S) mixed with an adjuvant (AS01). The ChAd63 ME-TRAP     and MVA ME-TRAP vaccines are called viral vectored vaccines. They are made from viruses which     are modified so that they can not multiply. The viruses have extra DNA in them so that after     injection, the body makes malaria proteins (but malaria does not develop), so that the immune     system builds a response to malaria without having been infected by it.      Healthy volunteers will be recruited in England at three research sites: in Oxford, London     and Southampton.   "
107148|NCT01883596|"     To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with     placebo to prevent ventilator associated pneumonia in children admitted to a pediatric     critical care unit.   "
107149|NCT01883583|"     To check the possibility of the acquisition of a number of parameters through real-time     contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with     pathologic results from ultrasound guided biopsy of transplanted kidney   "
107150|NCT01883570|"     Currently, teaching X-ray interpretation to medical students is not standardized, and is     generally not very effective.      Objective: The goal of our study is to evaluate whether directly teaching an expert search     strategy for x-ray interpretation to 3d year medical students is effective.      Methods:        -  An expert's visual search strategy was recorded using a gaze-tracking device. The search          strategy was then reproduced using a dynamic cursor moving across the corresponding          chest x-ray, and incorporated into a teaching program accessible via the internet.        -  Participants are 3rd year medical students who will be randomized into two groups. The          experimental group will have access to the teaching program as described. The control          group will have access to the same x-rays but not the expert's search strategy.        -  At the end of the study period the investigators will collect performance data (the          participants' accuracy at reading a series of chest x-rays) and process data (using          gaze-tracking to evaluate the participants' search strategies); the experimental and          control groups will be compared.      Expected results:      The investigators expect the group trained in expert search strategy to show improved     accuracy at reading chest x-rays, and an improvement in their visual search strategy   "
107151|NCT01883544|"     The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and     pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and     female subjects.   "
107152|NCT01883531|"     It is hypothesised that inhaled mannitol 400 mg b.d. will lead to a significant improvement     in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks of     trial treatment compared to treatment with inhaled placebo b.d.      Any improvement in FEV1 is considered clinically meaningful; however, this trial has set a     threshold of 3% for the purposes of determining an appropriate sample size for statistical     power whilst retaining trial feasibility in an orphan disease population.   "
107153|NCT01883518|"     The purpose of this study is to achieving a six-month progression free survival (PFS) of     patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor     lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas   "
107154|NCT01883505|"     This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD)     subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor     fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa     pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory     drug delivery pump following repeated dosing of ND0612 in a conventional home setting in     Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa     and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in     subjects with PD and motor fluctuations.   "
107155|NCT01883492|"     The primary objectives of this clinical study include:        -  Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who          received Total Hip Arthroplasty with E1        -  Compare E1 wear used with CoCr and Biolox Delta heads   "
107156|NCT01883479|"     The purpose of this study is to examine the efficacy of the active interventions (exercise or     wellness/support intervention) compared to usual care on the prevention of postpartum     depression among women at risk for depression. The investigators will also examine the     efficacy of an exercise intervention compared to a wellness/support intervention on     postpartum depressive symptoms among women at risk for depression.   "
107157|NCT01883466|"     Urban air pollution is a major contributor to greenhouse gases and has been shown to increase     cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing     and research, with biodiesel emerging as one of the strongest contenders within international     markets. The pursuit of alternative renewable fuels is incredibly complex and has powered     research in agriculture, biotechnology, production, transportation, feedstocks, ecology and     biomass manufacturing. In spite of this, health effects have been an almost completely     overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust     exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further     investigations into the chemical composition of biodiesel exhaust will also be performed.   "
107158|NCT01883453|"     Healthy persons are invited to participate in the study and are given a home protocol     (WURSS21), nasal spray and a sample pin. The included persons are told to make a     nasopharyngeal sampling from the nose when they are sure that they have caught a common cold.     After the sampling they start to spray and also fill in the records daily. The aim of the     study is to investigate whether a nasal spray with glucose oxidase could shorten an episode     of common cold.   "
107161|NCT01883414|"     Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on     one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after     treatment. Study images will be obtained before treatment, immediately after treatment and at     each follow-up visit.   "
107162|NCT01883401|"     Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia     while no such studies with whole strawberries have been reported in the US population. The     investigators propose to examine the effects of low and high doses of freeze-dried     strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and     inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and     dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the     low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories)     group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and     the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws,     anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks     of the study to determine chronic and acute effects of strawberry intervention. Serum or     plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total     cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of     oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high     sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated     measures ANOVA will be performed using a 5% significance level. We anticipate a dose response     effect in decrease in lipids, oxidative stress or inflammation following strawberry     intervention versus controls.   "
107163|NCT01883388|"     NovellusDx early detection test is a simple to perform blood test, which identifies the     deregulated signaling pathways within the patient tumor based on protein secretion to the     blood, thus enabling early stage disease signature detection. The investigators' current     clinical trial is focused on proving the main feature of NovellusDx's Early Detection Test-     discriminating between cancer patients and healthy subjects.   "
107164|NCT01883375|"     Dying patients and their families face many challenges near the end-of-life. Not only do     patients often experience physical distress, but they also have feelings of loss of dignity,     isolation, and uncertainty. Family members also face many challenges. They bear witness to     the suffering of loved ones, and they face uncertainty, loss, and at times a mounting sense     of helplessness.      The purpose of this study is to introduce and evaluate a new intervention called Dignity     Talk, meant to enhance end-of-life experience for both patients and their families. Dignity     Talk is based on a set of questions by which terminally ill patients and their family members     can engage in meaningful conversations with each other. It is intended to lessen feelings of     loss and helplessness and enhance feelings of connectedness by facilitating conversations     that tap into a sense of meaning and purpose, sharing of memories, wishes, hopes, and giving     guidance to those who will soon be left behind.      In Phase 1, 20 patients and family members will help finalize the method and Dignity Talk     question framework (is it easy to understand, do the investigators have the right questions,     and is the wording sensitive). In Phase 2 of the study the investigators will ask 100     patient-family pairs for feedback about Dignity Talk: what influence it had on their     palliative care experience, whether it works well, and whether this intervention should     become a regular part of palliative care. The investigators will also ask for feedback from     health-care providers in both phases. We are requesting approval for an amendment to the     healthcare provider feedback focus group questions. Will add those documents when they are     approved.      Four to six months after the death of their loved one, the investigators will contact the     family member to ask their thoughts about Dignity Talk, how it shaped their experience of     their grief and bereavement.      The investigators expect that the study will show that Dignity Talk can be an effective,     highly accessible palliative care intervention, which will enhance the end-of-life experience     for palliative patients and the families who support them.   "
107165|NCT01883362|"     To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy     reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem     cell transplant,   "
107166|NCT01883349|"     The purpose of this study is to understand cognitive impairment in end stage renal disease     before and after a kidney transplant.   "
107167|NCT01883336|"     This study intends to investigate the long term follow-up of small non-inflammatory     pancreatic cysts.   "
107168|NCT01883323|"     This is a phase II clinical study for patients with metastatic (the cancer has spread to     other parts of the body) melanoma. Patients will receive an infusion (given by vein) of     autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that     recognizes tumor cells and enter them which causes the tumor cells to break down.      Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and     fludarabine to prepare the body to receive the TILs. After cell infusion, patients will     receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. This     study will see how useful this regimen is in treating metastatic melanoma.   "
107169|NCT01883310|"     Aims of the study:      This is a double-blind randomized-controlled trial to test the effects of a task oriented     training combined with cerebellar transcranial direct current stimulation on locomotor     function, mobility and balance in multiple sclerosis subjects with moderate gait impairments     (EDSS 4-5,5).      Subjects and methods: 30 multiple sclerosis patients will be recruited in an outpatient     rehabilitation clinic University Hospital Ferrara. Informed consent will be obtained.     Participants enrolled will included in 2 different treatment groups: Task Oriented Circuit     Training (TOCT) + anodal cerebellar transcranial direct current stimulation (experimental     group) and TOCT + sham transcranial direct current stimulation over the cerebellum (control     group). The group with anodal transcranial direct current stimulation will receive continuous     stimulation with intensity of 2 mA during the first 15 minutes of functional circuit     training. In the sham session, anodal transcranial direct current stimulation was applied for     30 s and then shut off. Each subject will receive 10 task-oriented training sessions over 2     weeks (5 sessions/week). 3 subjects with a supervisor physiotherapist will take part at the     TOCT. During the stimulation sessions both the subject and the researcher, responsible for     carrying out clinical tests, will be unaware of the type of stimulation set.      Treatment efficacy outcome measures will be clinical test for gait speed (Timed 25-Foot     Walk), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility     (Time Up and Go Test); self-assessment questionnaire for motor fatigue (Fatigue Severity     Scale FSS) and quality of life (Short Form (36) Health Survey).      Outcome measures will be assessed the week prior to treatment initiation (T0), the week after     the end of treatment (T1) and at 3 months follow-up (T3) to evaluate treatments retention, by     a clinician blinded to the treatment. At the end of each session, the subject will complete a     questionnaire where report side effects due to stimulation (headache, neck pain, burning,     redness and/or itching in the site of stimulation).   "
107170|NCT01883297|"     This is a phase I clinical study for patients with platinum resistant (does not respond to     platinum-based chemotherapy) high grade serous ovarian, fallopian tube, or primary peritoneal     cancer. Prior to the main treatment, patients will receive cyclophosphamide by vein. Patients     will then receive an infusion (given by vein) of autologous tumor-infiltrating lymphocytes     (TILs) which will first be taken from the patient, then be stimulated with certain substances     called autologous dendritic cells (DCs) and OKT3 (anti-CD3 antibody), and then given back to     the patient as an infusion. This is believed to make the TILs work better. TILs are a type of     white blood cells that recognizes tumor cells and enter them which causes the tumor cells to     break down. After infusion of TILs, low-dose interleukin-2 (IL-2) therapy will be given.   "
107171|NCT01883284|"     Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of     epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects     firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4     and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an     air-liquide interface culture of nasals cells from CF patients or controls.   "
107173|NCT01883258|"     The study objectives are:        1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.        2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate          exercise on cardiovascular function in adults with type 2 diabetes.        3. To examine the mechanisms underlying the exercise-related changes in cardiovascular          function.      The investigators hypothesize that compared to continuous moderate intensity exercise     training, interval training will be more effective in improving cardiovascular function in     adults with type 2 diabetes.   "
107174|NCT01883245|"     Patients affected by chronic orofacial pain represent an emergent medical problem due to the     lack of knowledge on the cause, pathophysiology and psychology of many of these conditions,     that belongs to a multifactorial origin.      Particularly, temporomandibular joint disorders involve a series of symptoms that refers both     to intrinsic and extrinsic joint conditions where pain can be associated to a reduction of     the joint movement, click or to other sounds of the joint.      The lack of a recognized causal therapy led to the suggestion of many treatment modalities     with a multidisciplinary approach for the management of symptoms that include the use of     occlusal splints, physiotherapy-speech therapy, behavioral and physical therapy, drugs,     chirurgical approaches. In most cases these strategies together allow the control of the     symptoms, even though they aren't completely resolutive.      In these patients is frequent chronic pain and ineffectiveness of common drugs used.      It has been demonstrated how transcranial electrical brain stimulation with direct current     (tDCS) is able to reduce the intensity and the duration of chronic pain.      Stimulating the motor cortex can reduce pain by modulating brain activities in the areas     involved in cerebral circuits controlling pain, such as thalamus, facilitating the descendant     inhibitory mechanisms and enhancing the number of opiates receptors.      This clinical trial is based on the evaluation of the effects of tDCS on pain and on     activities daily living (ADL) participation patients with chronic orofacial pain that don't     respond to other treatments.   "
107175|NCT01883232|"     As a dentist, administering anesthetic to patients, especially children, proves to be one of     the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry,     and a serious concern for the dentist. The pain of the local anesthetic injection has several     causes. Of the many reasons for pain at the site of injection, the acidity of the solution is     thought to be most important. This study will be measuring the effects of adding sodium     bicarbonate (buffer) to local anesthetic during dental procedures. This is commonly used in     medical applications but is not widely used in the dental setting. Using this biochemistry     and human physiology, one can predict when buffering the lidocaine injection, a quicker     response in analgesia and a decrease in pain during administration. I will be measuring the     effect using several measuring devices to gauge if buffering the local anesthetic will     benefit the pediatric dental patient by reducing the time it takes for the analgesic effect     as well as decreasing the pain during administration. Along with time, I will be using the     Wong-Baker Scale to assess the pain. This scale is standard protocol for assessing pain in     the pediatric population. The pediatric dental population has aversions to dental procedures     because of the associated pain produced from most procedures. If limiting the time it takes     for the analgesic to take effect and decrease the pain altogether, the pediatric patient will     be less likely to skip treatment therefore, increase dental health.   "
107176|NCT01883219|"     The purpose of this study is to evaluate the efficacy of tyrosine kinase inhibitor(TKI)     therapy based on molecular monitoring of BCR/ABL levels in Philadelphia chromosome-positive     acute lymphoblastic leukemia (Ph+ ALL)undergoing allogeneic hematopoietic stem cell     transplantation(allo-HSCT).   "
107177|NCT01883206|"     The purpose of this study is to see how well the antibody levels found months to years after     patients entered a previous randomised placebo-controlled trial of a glycoprotein B vaccine     against cytomegalovirus have persisted and to have the previous samples retested using     different methods which have been further developed in different laboratories.      Also, to prepare monoclonal antibodies from the B lymphocytes of these patients and define     their strength. If potent antibodies are identified, the investigators would like to consider     developing them further to see if they can protect future transplant patients against     cytomegalovirus.   "
107178|NCT01883193|"     Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain     the benefits of ensuring optimal maternal nutrition before conception and providing an     evidence base for programmatic priority directed to minimizing the risk of malnutrition in     all females of reproductive age.   "
107179|NCT01883180|"     The purpose of this study is to compare the incidences of GVHD and viral infections in     haploidentical hematopoietic stem cell transplant recipients receiving different dose of     antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our     first objective was to investigate the optimal dose of ATG for aGVHD and second object was to     evaluate the effect of different dose of ATG on post-transplant viral infection.   "
107180|NCT01883167|"     This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD)     interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor     RDEA3170 and provide information for potential future clinical studies using this     combination. Combination treatment using 2 drugs with different mechanisms of action may     achieve improved response and may allow the use of lower doses, resulting in fewer side     effects than the use of either drug alone.   "
107181|NCT01883154|"     Genetic and environmental factors are believed to play a major role in intrauterine growth     and intrauterine programming. We intend to study genetic factors such as Telomere     homeostasis, senescence, genomic instability and the presence of Genomic copy number     variations in placental tissue from pregnancies complicated with Intrauterine growth     restriction(IUGR), Gestational and pre gestational Diabetes, placentas from IVF pregnancies     and from normal pregnancies. We also intend to assess these factors in cord blood and     maternal blood.   "
107205|NCT01882842|"     This study aims to see if taking a small sample from the lining of the womb (the 'scratch')     before starting in vitro fertilization (IVF) treatment can influence the chance of getting     pregnant and having a healthy, term baby.      This study also aims to explore why an embryo is not accepted or indeed rejected by the     lining of the womb. This will be analysed by carefully looking at the sample taken from the     lining of the womb under the microscope and analysing the levels of natural killer (NK)     cells. These cells are thought to regulate the implantation process and to be altered in some     women with infertility and miscarriage.   "
107183|NCT01883128|"     Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four     men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment     which has significant side effects. Few men are offered a further treatment such as surgery,     HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators     believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately     detect whether cancer has come back inside or outside of the prostate or both. Also     radiotherapy damages tissue surrounding the prostate which affects tissue healing for example     after surgery. Treating just the cancer in the prostate only (focal treatment) rather than     the whole prostate may limit this damage and cause fewer side-effects. The investigators want     to see if new imaging tests can better identify cancer that has spread outside of the     prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for     distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the     investigators will compare the results of whole-body MRI to existing imaging tests     (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators     will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate     called template prostate mapping which will show us where and how aggressive the cancer is.     Third, if the cancer is confined to the prostate, the investigators will treat men using     focal salvage therapies HIFU and cryotherapy. The investigators believe that these new     imaging tests could better identify those who will benefit from early hormone treatment and     those who will benefit from local salvage treatment. Our study may help justify carrying out     a larger trial looking at how good the treatment is in controlling cancer in the medium and     long-term.   "
107184|NCT01883115|"     Our recent prospective randomized controlled study comparing single-port vs. multiport     laparoscopic total extraperitoneal inguinal herniorraphy (NCT 01660048) demonstrated     superiority of the single-port technique in reducing post-op pain/analgesic requirements,     quicker return to work/normal physical activities and improved cosmetic scar scores. During     this study all patients underwent the initial extraperitoneal dissection with the distension     balloon. However, the balloon itself costs AU $380 per device which represents a significant     percentage of the overall cost of the procedure (when the hospital/operating rooms cost is     approximately AU $2500 for a unilateral laparoscopic inguinal hernia repair) especially if     only unilateral inguinal herniorraphy is performed.      The European Hernia Society Guidelines encourage the use of the distension balloon for the     initial distension/dissection of the extraperitoneal space especially during the learning     curve. This recommendation arises from the fact that during the conventional multiport repair     the umbilical port allows only the insertion of the laparoscope and the extraperitoneal space     cannot easily be dissected with the scope itself, especially in patients with well-developed     linea alba extending down to the pubic symphysis, and the camera itself, if used as     dissection device, would become smudged and it would have to be repeatedly withdrawn for     cleaning. Yet this must occur since the extraperitoneal space must be dissected in the     midline sufficiently for safe insertion of two additional 5 mm ports for insertion of     dissecting instruments in order to complete the extraperitoneal space dissection and the     repair.      With single incision laparoscopic surgery the use of the Triport™ system ensure that the port     can be place under direct vision into the extraperitoneal space when the scope and two     dissecting instruments can be safely inserted at the outset. In this way the extraperitoneal     space can be dissected under direct vision. The balloon dissection is essentially a blind     dissection even though the balloon distension is being observed by the scope, incorrect     tissue planes can be entered ie the dissection can occur below the pre-peritoneal fascia     exposing the nerves in the groin with the potential risks for nerve damage and entrapment.     This is an argument that surgeons who practise transabdominal preperitoneal inguinal hernia     repair use to justify their superior technique over the TEP repair because, in the TAPP     repair, the peritoneum is carefully dissected free from and leaving the underlying     preperitoneal fascia intact.      While the use of the balloon, when some 25 pumps of air are used during the insufflation,     to create a significant space to place not only the two 5 mm ports but also to create a     significant extraperitoneal dissection when usually only the lateral space and the hernia sac     need to be dissected this is not always possible. In patients who have had previous lower     abdominal surgery including previous anterior inguinal herniorraphy (especially if the mesh     plug is used) the balloon dissention is normally judicious as one cannot predict whether     there are any significant peritoneal or even bowel adhesions. Consequently, in such cases,     the balloon distension is normally confined to an area just inferior to the umbilical port     and superior to the pubic symphysis so that there is just enough extraperitoneal dissection     to place the two 5 mm trocars. Usually this means only using only 5 pumps of air in the     distension balloon for placement of two 5 mm trocars. Then the dissection of the     extraperitonealy space under direct vision can take place. The use of the distension balloon     in such cases represents an enormous waste of resources since AU $380 is spent just to create     enough space to place the two 5 mm ports and hence allowing the insertion of the dissecting     instruments. With the Triport+™ port the dissecting instruments can easily be placed in the     extraperitoneal space and the dissection can begin under direct vision hence achieving the     same safe dissection that TAPP surgeons claim to perform.      In this study we aim to look at the safety and efficacy of telescopic vs. balloon dissection     by prospectively comparing a similar former group of patients to the ones who had previously     undergone single-port inguinal herniorraphy with balloon dissection in our previous study     (NCT 01660048).      All patients having surgical treatment of groin hernia at St Luke's and Holroyd Private     Hospitals are subject to very careful assessment and study. All patients are requested to     report immediately if there are any problems.   "
107185|NCT01883102|"     This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the     body; counts of which are used to determine a disease of nerves called small nerve fiber     neuropathy.      Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1%     capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such     ablation results in relief of spontaneous pain, touch, or heat-pain.   "
107186|NCT01883089|"     The current study combines both clinical trial and daily process methodology to examine the     dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e.,     craving) and drinking behaviors in those diagnosed with an Alcohol Use Disorder (AUD) prior     to, during, and after receiving a brief alcohol intervention. It is hypothesized that daily     avoidance inclinations will significantly moderate the effect of daily approach inclinations     on drinking behaviors, and that significant increases in avoidance inclinations will be     observed prior to treatment entry, followed by significant decreases in approach inclinations     during treatment.   "
107187|NCT01883076|"     This is a Phase I study to determine the safety and feasibility of injections of autologous     umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome     (HLHS) children undergoing a scheduled Glenn surgical procedure.      The investigators are doing this research study to find out if autologous stem cells from the     individual's own umbilical cord blood can be used to strengthen the muscle of the right side     of their heart. This will help determine the safety and feasibility of using cell-based     regenerative therapy as an additional treatment for the management of HLHS.   "
107188|NCT01883063|"     This is a prospective multi-site study. Subjects with distal radius fractures will be     enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed     non-operatively with a splint or cast. Subjects will be enrolled in each group according to     physician's standard of care (either casting/splinting or surgery) for distal radius     fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a     final qualifying decision made by a group of three independent adjudicators. The final     qualifying review should allow for similar patient groups within each arm of the study due to     the variability that can arise in fracture classification. Review by the adjudicators should     be completed within 1 week.   "
107189|NCT01883050|"     Patients who recently suffered a heart attack will use a smart-phone/computer application     during cardiac rehabilitation to reduce their risk of a future attack, their     re-hospitalizations, their cost of care, and increase their quality of life.   "
107190|NCT01883037|"     There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue     glucose 201 RT system with the laboratory gold standard.      The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients'     survival improves. Around 30% of all cystic fibrosis (CF) adult patients have CFRD. Early     diagnosis of CFRD is important to slow the deterioration of lung function and nutritional     status, both of which increase mortality.      The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the     Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years     should be screened annually.      The World Health Organisation has pointed out that due to the absence of a more specific     biological marker to define diabetes, plasma glucose estimation remains the basis of     diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method     for measuring and reporting glucose concentration in blood. However, it has also recognised     that there is a widespread use of capillary sampling. Although fasting values for venous and     capillary plasma glucose are the same, in the nonfasting state capillary samples will give     higher results than venous samples, and glucose values require conversion which can be     problematic.      HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory     quality test results at the point of care for the diagnosis, screening and monitoring of     diabetes mellitus. The analyzer is easy to use and the system can be operated by     nonlaboratory personnel, also the results can be presented immediately, leading to     significant time and resource saving. The patient also benefits from having the result     immediately instead of waiting for several hours. With immediate result, the doctor and     health care professionals can provide education, support and reassurance, and implement care     plans, if appropriate, at the earliest opportunity.      The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the     laboratory standard method in the analysis of blood glucose concentration during oral glucose     tolerance test.   "
107191|NCT01883024|"     The purpose of the study is to assess the relevance of the advices provided by the IPRA©     smartphone application for guiding the responses of insulin pump treated type 1 diabetes     patients using real-time continuous glucose monitoring.   "
107192|NCT01883011|"     The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment on     the aphasic status of subjects suffering from aphasia after acute ischemic middle cerebral     artery stroke and having received their medication within 7 h post-stroke onset.   "
107193|NCT01882998|"     This study aims to test the effectiveness of a behavioral intervention aimed at preventing     the primary acquisition of HIV by uninfected pregnant and lactating women in Uganda, East     Africa where HIV transmission is high. Women who acquire HIV during pregnancy or lactation     are at higher risk of adverse health and pregnancy outcomes and their baby is at high risk of     acquiring HIV and dying.      Keeping HIV-uninfected women uninfected during pregnancy and lactation is an important     component of the global World Health Organization (WHO) strategy to eliminate mother-to-child     transmission of HIV but there has been no study to date to assess interventions that can     effectively keep these women uninfected.      In this study, the investigators will test the hypotheses that:        1. extended repeat HIV testing and enhanced counseling (ERHTEC) during late pregnancy (>36          weeks) and breastfeeding can increase and sustain risk reduction behaviors and prevent          incident STI and HIV infections among HIV-uninfected pregnant women, and        2. that couple HIV testing and counseling (HTC) can further enhance this effect through          improved couple communication and emotional and economic support from male partners.   "
107195|NCT01882972|"     Despite a robust literature on the benefits of exercise for cancer survivors, most of the     research to date falls in two primary areas - aerobic exercise and breast cancer survivors.     The focus on aerobic training alone is a concern as resistance training is critical for     building the muscle mass necessary to maintain physical function. However, concerns have been     raised about the potential for higher than tolerated adverse event rates during resistance     training, particularly that which is unsupervised, despite a history of safe use of     resistance training in other chronically diseased patient populations. The aim of this pilot     study is to demonstrate the feasibility, safety and quality of life benefit of a home-based     resistance-training program among colorectal cancer survivors. The investigators will recruit     n=30 men and women with stage I-III colon cancer. Participants will be randomized to a     home-based exercise intervention that combines aerobic and resistance exercise. Control arm     participants will receive a home-based meditation program.   "
107196|NCT01882959|"     The meta-analysis of data obtained from randomized controlled trial on effectiveness of     radiofrequency denervation on reducing chronic neck and low back pain.   "
107197|NCT01882946|"     The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the     treatment of solid tissue tumors will be identified, followed by a Phase II component to     determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability     to reduce tumor growth.   "
107198|NCT01882933|"     A prospective, opened, multicentric, randomised, phase III trial with two arms:        -  Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin        -  Arm B: curative gastrectomy with D1-D2 lymph node dissection      Main objective: Compare overall 5-year survival rates in patients surgically treated for     advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology),     treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy     alone.   "
107199|NCT01882920|"     The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic     intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy     combined with goal directed fluid therapy (GDT) is associated with a significant change in     morbidity, length of hospital stay and mortality compared to a standard fluid therapy.     Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT     group receive fluid intravenous therapy according to a specific treatment protocol guided by     monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to     assess stroke volume and cardiac output via an automated pulse contour analysis     (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and     colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group.     In both groups, the investigators evaluate the incidence of major abdominal and systemic     complications, the total duration of hospital stay, mortality, the total amount of fluids     administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses     administered.   "
107200|NCT01882907|"     The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin to     pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes inadequately     controlled with metformin monotherapy.   "
107201|NCT01882894|"     The aim of this randomized control trial is to identify the possible effectiveness of the     temporary use of an inexpensive, custom-made plantar fascia orthotic (PFO).   "
107202|NCT01882881|"     The purpose of this study is to investigate the individual and combined effects of dark     chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation,     phenolic acids, inflammatory status, blood pressure and arterial health. It is hypothesized     that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins,     antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy     American control diet; however, the effects will be greater when dark chocolate/cocoa and     almonds are consumed together versus consumption of each food individually.   "
107203|NCT01882868|"     Primary Objective:      To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by     objective response rate (ORR).      Secondary Objective:      To assess the following:        -  safety profile;        -  progression free survival (PFS);        -  overall survival (OS);        -  pharmacokinetics (PK);        -  immunogenicity.   "
107204|NCT01882855|"     Hepatic encephalopathy (HE) is a potentially reversible, metabolically caused complication of     acute or chronic liver diseases such as cirrhosis. Due to the diseased liver's inability to     remove toxins such as ammonia, which is produced in the gastrointestinal tract, the ammonia     accumulates in the brain and causes forgetfulness, confusion, disorientation, concentration     and memory problems, changes in mood, decreased alertness and responsiveness, changes in     sleep habits, muscle tremors and stiffness, speech impairments, uncontrollable movements,     agitation.      This study will examine music as a possible external factor that could contribute to     impairment in attention and progressive memory in cirrhotic patients while driving.     Sustaining attention is important for learning and remembering new information, for e.g.     keeping the car within lane and paying attention to cyclists and pedestrians. Prospective     memory is the ability to remember to perform previously intended tasks at the appropriate     time or occasion, for instance remembering the correct exit while driving on the highway.     Impairment in any of these areas may result in serious consequences for patient with     cirrhosis. There is evidence that some subsets of cirrhotic patients have a diminished     ability to drive and significantly more motor vehicle crashes and traffic violations. In     these patients, listening to music while driving may further jeopardize their driving     ability, which in turn may lead to reduced quality of life and increased medical costs (from     motor vehicle accidents).      This is a cross-sectional study designed to determine if there is any effect of listening to     music on attention and prospective memory in patients with cirrhosis. For these purposes,     subjects will be asked to come for one study visit, which will last approximately 2 hours.     During this visit, subjects will undergo a series of screening procedures (consent,     assignment of subject identification number, demographics, medical history, physical     examination, vitals, height, weight, and eligibility assessment). If they are found eligible,     subjects will undergo several neuropsychological assessments to measure any effect of music     on attention and prospective memory. These assessments include including Number Connection     Test (NCT), Digit Symbol Test (DST), Cambridge Prospective Memory Test (CAMPROMPT) and     Inhibitory Control Test (ICT).   "
107338|NCT01881100|"     It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of     smooth-surface caries lesions in deciduous teeth reduce considerably the progression of     treated caries lesions, compared to fluoride varnish therapy only.   "
107206|NCT01882829|"     There is an urgent need, therefore, to identify well-tolerated, orally available compounds     that target the NMDA receptor as a novel treatment approach for TRD. The current project aims     to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA antagonist     dextromethorphan.   "
116085|NCT01766401|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone     relative to placebo in the treatment of generalized anxiety disorder (GAD).   "
107209|NCT01882790|"     Autonomic nerve function is involved in both blood pressure (BP) regulation and the     pathogenesis of coronary artery spasm(CAS), but few studies have been published about the     relationship between CAS and effect of BP lowering drugs in patients with hypertension. The     purpose of this study is to investigate the incidence of CAS, atrioventricular (AV) block and     effect of BP lowering drugs on CAS in hypertensive patients treated with BP lowering agents.     The investigators will register consecutive patients who underwent coronary angiography with     an acetylcholine (Ach)-induced provocation test. The investigators will include hypertensive     patients who were taking antihypertensive drugs, and exclude patients who had a documented     history of cardiovascular disease or who were not treated with antihypertensive agents. CAS     is defined as >70% luminal narrowing on Ach provocation and /or concurrent chest pain. The     study population will be divided into quartiles of rising systolic BP and diastolic BP. The     incidence of Ach-induced CAS according to each systolic BP/diastolic BP quartile will be     evaluated.   "
107210|NCT01882777|"     DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are     collaborating on a project financed by carbon credits that will distribute household-based     water filters and high-efficiency cook stoves to approximately 700,000 households in Rwanda.     Prior to the full roll out of the campaign, the implementers are conducting a pilot project     among 2000 households in western Rwanda. The objectives of this pilot evaluation are to     document the delivery of the intervention to the intervention population, assess coverage and     uptake of the intervention target households and conduct a 5-month randomised controlled     trial among 500 households to assess the impact of the intervention on drinking water quality     and indoor air quality.   "
107211|NCT01882764|"     A study with an 8 week open label phase study followed by a year long placebo controlled     maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a     modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent)     as a concomitant medication. Subjects are required to be in clinical remission or clinical     response to enter the year long maintenance phase. This study will help evaluate if HMPL-004     is effective in subjects maintaining clinical remission following successful induction     therapy achieving clinical remission or clinical response.   "
107212|NCT01882751|"     A better understanding of knee joint kinematics is important to explain the premature     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a     prosthesis that most closely approximates the normal knee. Previously, most experimental     studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the     knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that     permit error due to undesired motions between markers and the underlying bone. More recently,     fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.      ConforMIS has attempted to follow a clearly different path than the major orthopaedic     companies. They have chosen to offer patients a personalized knee implant based off of each     patient's femoral and tibial bone geometry. The hypothesis is that these subjects will     experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding     during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the     in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25     patients implanted with a traditional TKA design to determine if there are any kinematic     differences between these TKA designs.   "
107213|NCT01882738|"     All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate.     Cervical length will be assessed in all patients, once abdominally and then vaginally (that     would serve as golden standard). Correlation would be assessed between accuracy of     measurement to BMI   "
107214|NCT01882725|"     The purpose of this study is to determine whether low level laser light therapy is effective     in increasing local blood circulation in people with chronic heel pain arising from plantar     fasciitis.   "
107215|NCT01882712|"     The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel     0.5% applied topically once daily for 29 days versus vehicle control, in subjects with     moderate to severe chronic persistent vascular facial erythema   "
107241|NCT01882374|"     The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence     (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double     umbilical cord blood transplantation (UCBT). The study will also evaluate the effects of     TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and platelet     recovery; platelet transfusion requirements; immune reconstitution; and duration of     corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce     rapid production of neutrophils and platelets in the bloodstream, as well as increase the     immune system components. TXA127 has also been shown reduce the severity of     chemotherapy-induced mucositis.   "
107339|NCT01881087|"     The purpose of this study is to evaluate motor block probability throughout time and clinical     profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a     unilateral spinal block technique.   "
107216|NCT01882699|"     This study will build upon a previously approved protocol entitled A multi-center     prospective, blinded, randomized crossover study to compare the Cerêve Sleep System at two     different temperatures in primary insomnia patients (CIP-003; CER1-01-090). In that study,     150 insomnia patients were targeted to be randomized to complete in lab assessments of sleep     using the Cerêve Sleep System. In this follow-on study, 36 patients who completed the in lab     study will be enrolled to complete 2 phases of in home use of the device. In the first phase,     the durability study, 30 patients are targeted to complete additional in lab assessments     following 30 days of in home use of the device. In the second phase, the home use pattern     study, 24 patients are targeted to complete an additional 5 months of in home use in which     their use patterns will be monitored.      Hypothesis:      EEG sleep latency and sleep efficiency following 30 days in home use of the device at 14-16°C     will be similar to those measures after the initial acute, 2-night use in the parent study in     the 14-16°C condition. The device will demonstrate a benign safety profile over 6 months in     home use.   "
107217|NCT01882686|"     A series of case-studies to explore the efficacy of classification based cognitive functional     physiotherapy according to the classification system proposed by Peter O'Sullivan in specific     nursing population with non specific chronic low back pain.      The investigators hypothesis was that treatment targeting the mechanisms behind the problem     from a multidimensional perspective would be effective to reduce pain, disability and     sick-leave.   "
107218|NCT01882673|"     The long-term goal of this program of research is to disseminate an effective, brief     computer-based intervention that can be readily integrated into Substance Use Disorders (SUD)     treatment programs to motivate tobacco quitline use in patients who smoke. The overall     objective of this application, which is the first step in the attainment of this long-term     goal, is to fully develop this computer-based intervention, modify it based on initial     piloting and feedback to insure its feasibility and acceptability, and obtain preliminary     data supporting the efficacy of the intervention. This will be accomplished by pursuing three     specific aims: 1) to develop and conduct preliminary pilot testing (n=20) of a brief,     computer-based intervention intended to motivate tobacco quitline use among cigarette smokers     in SUD treatment (TIME-TQ; Tablet computer Intervention to Motivate Engagement in Tobacco     Quitline use) and to develop and pilot test a computer-based, time matched control     intervention (CON), 2) to conduct a preliminary randomized controlled trial (RCT) with 60     smokers in SUD treatment, comparing TIME-TQ vs. CON, with predictions that TIME-TQ relative     to CON will result in increased readiness, higher rates of tobacco treatment engagement, more     quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1- and     3-month follow-ups. Substance use outcomes over the course of the 3-month follow-up period     will also be examined, and 3) to examine TIME-TQ's effects on key mechanisms during the     computer session and their associations with tobacco treatment engagement and smoking     outcomes at 1- and 3-month follow-ups.   "
107219|NCT01882660|"     Background of the study: Colon cancer is the second leading cause of cancer-related death     world wide.      Although patients presenting with early disease (stage I-III) can be cured, prognosis varies     from 90% in stage I to 50-80% in stage II and III. Therefore, prevention of metastases after     early disease is of utmost importance. Derepression of Wnt targets may provide a novel target     for therapy.      Objectives: The primary objective of the study is to assess in patients with primary colon     cancer whether short-course pre-operative treatment with decitabine can increase Wnt target     gene expression as measured in resected tumors compared to pretreatment biopsies. The     secondary objective of the study is to assess in patients with primary colon cancer whether     short-course pre-operative treatment with decitabine can revert CpG methylation and induce     more favorable tumor characteristics as measured in resected tumors compared to pretreatment     biopsies. The tertiary objective is to compare changes in Wnt target gene expression, CpG     methylation and tumor characteristics for Wnt methylated and nonmethylated tumors as measured     in resected tumors compared to pretreatment biopsies and identify new stratification markers.   "
107220|NCT01882647|"     This Phase 3 study has been designed to determine and compare the efficacy and safety of     000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque     psoriasis.   "
107221|NCT01882634|"     To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60     years through a screening program in Primary Health Care using a hand-held ultrasound and to     analyze the relationship between cardiovascular risk factors and cardiovascular disease in     patients with AAA.   "
107222|NCT01882621|"     Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity     induced by cisplatin   "
107223|NCT01882608|"     Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they     affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are     due to mood disorders. Mental health telemetry (MHT) lets patients in the community use cell     phones to track the severity of their mood symptoms over time, and enables clinicians to view     these symptom ratings in real-time. Evidence suggests that MHT is better for detecting     exacerbations of illness earlier than standard clinical practice alone. In this study, we     will assess if MHT can reduce re-hospitalization rates in previously-hospitalized patients     with mood disorders.   "
107224|NCT01882595|"     To compare lung deposition of amikacin in two settings: spontaneously breathing through a     tracheostomy cannula and through the mouth.   "
107225|NCT01882582|"     The purpose of this study is to better understand whether and to what extent the activity of     immune cells in blood varies over time under normal conditions as assessed in healthy     subjects. Results of this study will provide the foundation for helping us evaluate changes     in immune cell activities in response to surgery and drugs used in anesthesia. The overall     purpose of our research is to understand immune health in the context of anesthesia and     surgery.   "
107226|NCT01882569|"     Surgical trauma triggers a massive inflammatory response. Over time, both the innate and     adaptive branches of the immune system are affected by surgical trauma. The purpose of this     study is to use a single cell flow cytometry approach to characterize the cellular and     molecular mechanisms involved in the inflammatory response to surgical trauma.   "
107354|NCT01880892|"     In patients with gastroesophageal reflux and/or laryngopharyngeal reflux with cricopharyngeal     hypertrophy or Zenker's diverticulum, does cricopharyngeal myotomy increase the amount of     laryngopharyngeal reflux?   "
107227|NCT01882556|"     Patients who survive a stroke are often left with an arm that cannot be used. One reason for     this is that the muscles affected by the stroke become overactive. This is known as     spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead     to limb deformities. For example, the wrist and fingers in the arm affected by spasticity     become stiff and curl into a fist and the hand cannot be used for any functional purpose.     Palm hygiene can become difficult and patients find this deformity unsightly and painful.     Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this     purpose. In current practice this treatment is often used as a last line of defence. Although     BT can reduce the muscle overactivity, when injected using current protocols, it seems to     have little impact on the recovery of function and/or treating the limb deformities and pain.     If BT can be given in the early stages of a stroke, i.e. as soon as the muscle overactivity     is observed, then we will be able to treat spasticity and may prevent the limb deformities     and pain from developing. We may also be able to assist the recovery of arm movement in some     of the patients who would otherwise not have regained this. In addition to benefiting the     patient, the prevention of secondary complications by early treatment may reduce the costs of     long term care to the NHS . We hope to discover if our plan of providing early treatment with     BT is more effective than the current approach. If we demonstrate that the treatment is     effective we will be able to introduce this new method almost immediately within the NHS     through our collaboration with doctors and therapists who are actively treating patients with     this condition.   "
107229|NCT01882530|"     The combination of different analgesic drugs and/or analgesia techniques is part of the     standard management of postoperative analgesia. The analysis of the literature reveals a lack     of comparison of the associations of non-opioid analgesic (NOA) with morphine for     postoperative analgesia.      The objectives of this study are :        -  comparing the morphine sparing effect of different combination of 3 NOA (paracetamol,          nefopam, ketoprofen) for postoperative analgesia.        -  determining whether the morphine-sparing effect is associated with or without a          reduction in the incidence of morphine side effects.        -  evaluating the effects of NOA on postoperative hyperalgesia.   "
107230|NCT01882517|"     To determine the effect of investigational products on serum LDL cholesterol.   "
107231|NCT01882504|"     The study will evaluate the safety and biologic activity of gevokizumab in subjects in the     acute inflammatory phase of pyoderma gangrenosum.   "
107232|NCT01882491|"     The purpose of this proof-of-concept study is to determine whether gevokizumab is effective     in the treatment of inflammatory erosive osteoarthritis of the hand.   "
107233|NCT01882478|"     The purpose of this study is to determine whether cryotherapy is effective in the treatment     of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in     patients who have not responded to radiofrequency ablation (RFA).   "
107234|NCT01882465|"     Limbal ring contact lenses enhance the look of the eye by adding pigmentation in a ring     pattern to the contact lens. The purpose of this investigation is to determine if corneal     staining increase is dependent upon the lens pigment location.   "
107235|NCT01882452|"     Depression involves the tendency to recall overgeneral personal memories, a phenomenon which     has been linked to numerous adverse psychological outcomes. The purpose of this study is to     investigate whether a group-based Memory Specificity Training (MEST) programme improves     outcomes in depression, and how this compares to an education and support control group. The     primary aim is to examine whether MEST, which involves repeated practice retrieving specific     autobiographical memories reduces depressive symptoms immediately post-treatment, and whether     this is maintained 3 months after treatment. The secondary objective of this trial is to     examine the role of hypothesised cognitive processes (ie., rumination, executive control,     cognitive avoidance) which may underlie improvements in depression and memory.   "
107236|NCT01882439|"     To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis     who have previously had an inadequate response to at least one TNF inhibitor either due to     lack of efficacy or an adverse event.   "
107237|NCT01882426|"     Assess if standardized care-path that features objective evaluations of disease activity and     time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.   "
107238|NCT01882413|"     This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to     cataract surgery. No treatment is administered in this study.   "
107239|NCT01882400|"     By supplying an adequate amount of calcium and vitamin D with the addition of weekly     bisphosphonate, the investigators will be able to increase bone mass and decrease the     incidence of fragility fractures in these children with muscular dystrophy.      The investigators think this treatment will also decrease the intensity of pain frequently     present in these patients and slow the progression of scoliosis.   "
107240|NCT01882387|"     The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence     (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing allogeneic     peripheral blood stem cell transplantation (PBSCT). The study will also evaluate the effects     of TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and     platelet recovery; platelet transfusion requirements; immune reconstitution; and duration of     corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce     rapid production of neutrophils and platelets in the bloodstream, as well as increase the     immune system components. TXA127 has also been shown reduce the severity of     chemotherapy-induced mucositis.   "
107242|NCT01882361|"     To address the question of the comparison of two courses of Vivitrol with differing lengths     in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient     treatment. Participants will be randomized under double blind conditions to a 24 or 48-week     course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with     follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in     weeks 24 to 48.   "
107244|NCT01882335|"     The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in     the first 6 months of life on cognition and other determinants of human capital formation     including behavioral and emotional status; school readiness and attainment; health status;     fine and gross motor skills; physical growth; and household economic status.   "
107245|NCT01882322|"     The objective of this study is to compare the efficacy and safety between a group that has     been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group     that maintained Prograf twice daily therapy.   "
107246|NCT01882296|"     Primary object: Evaluate Pharmacodynamic property and safety administered S-pantoprazole 10,     20, 40mg and Pantoprazole 20, 40mg in healthy male subjects      Secondary object : Evaluate Dose-response of S-pantoprazole and pantoprazole and compare each     dose-response   "
107247|NCT01882283|"     A diet-controlled clinical trial which attempts to provide estimates of the effect of black     tea consumption on serum lipids under tightly controlled conditions, including a controlled     diet. Mildly hypercholesterolemic individuals (total cholesterol levels between 4.9 and 6.7     mmol/L, 190 and 260 mg/dl), non-smoking, chronic disease-free individuals were enrolled in a     15-week, double blind, randomized crossover trial, during which they consumed a controlled     low-flavonoid diet plus 5 cups of black tea or a tea-like placebo over two 4-week treatment     periods.   "
107248|NCT01882270|"     The purpose of this research study is to find out if the infection around 3rd molars and the     resulting inflammation around the gum also produces a general systemic inflammation.   "
107272|NCT01881958|"     Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of     the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder     containing 24 Amino-acids. We have proved in former studies that DiaPep277® can slow down     beta cells destruction in the pancreas and therefore decelerate the progress of Diabetes.      The objective of the study is to assess the efficacy and safety of administrating DiaPep277®     in type 1 diabetes patients.   "
107249|NCT01882257|"     -  Patients with spinal cord injury (SCI) usually breathe without any mechanical          assistance, but significant breathing problems occur often during sleep, either because          the upper airway closes (obstructive sleep apnea; OSA), or because of weakness/paralysis          of the breathing muscles. These problems often go unrecognized, as SCI patients face          logistical barriers that cause them to refuse appropriate testing in sleep laboratories.          We have devised a strategy for diagnosing sleep-disordered breathing in the patient's          home, using placement of noninvasive devices that monitor breathing overnight. This          project is designed to test the feasibility and utility of this strategy.        -  After collecting baseline data on symptoms and medical events for four months, the          home-based studies are performed noninvasively with FDA-approved devices: a type III          sleep system and a recording oxygen saturation/ transcutaneous carbon dioxide monitor.          If these studies identify sleep-disordered breathing, noninvasive ventilatory support is          prescribed according to standard clinical practice. Over the following twelve months,          the subjects monitor their symptoms daily, and answer quality-of-life questionnaires          every three months. After 3, 6, and 12 months, blood tests are performed to measure          blood sugar and cholesterol/lipids. Data is downloaded from the ventilator device to          monitor compliance and ventilator performance. This study is designed to determine the          prevalence of sleep-disordered breathing in SCI, the feasibility of home-based testing          to establish the diagnosis, and the short term effects on symptoms, quality-of-life, and          associated conditions (glucose intolerance, blood lipid disorders).   "
107250|NCT01882244|"     Injury to the brain can change the core of a person's being, affecting brain functions     necessary to accomplish important goals in a complex world. Deficits in attention, working     memory, and other aspects of goal-directed cognition affect a broad range of pursuits in     everyday life, and are among the most prevalent and long-lasting consequences of brain     injuries. The objective of this research is to develop remotely deployed training tools that     target the most common, persistent and debilitating cognitive functions affected by traumatic     brain injury (TBI); test the potential effects of the intervention and compare these effects     to an active comparison intervention; and determine the neurocognitive and functional effects     of computer-assisted remote training.   "
107251|NCT01882231|"     The objective of these studies is to use changes in 3 Tesla MRI measurements of tumor protein     content, cell density, and microvessel perfusion, obtained before and after a single cycle of     NAC, to predict eventual tumor response observed at the conclusion of NAC, within patients     with osteosarcoma or Ewing Sarcoma.   "
107252|NCT01882218|"     The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a     sugar solution into the abdominal cavity) helps blood flow through vital organs in the body     that may suffer from low blood flow due to surgery. We will also try to find out if the DPR     will help patients recover faster from liver surgery. Lastly, this study will also try to     find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood     called 'cytokines' and a protein called high-mobility group protein 1, which is known to     cause tissue damage.   "
107253|NCT01882205|"     The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the     rectum is increased and therefore patients should be enrolled in a surveillance program eight     years after the diagnosis. Until today, official international guidelines for endoscopic     screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters     (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely     based on consensus during expert opinion meetings rather than evidence based. Recent studies     have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies     for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore     considered the gold standard in this study in which we want to compare it to the performance     and efficiency of new endoscopic imaging techniques.      Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading     to a shift in the excitation spectrum towards blue light. The first studies with NBI showed     that the additional value of NBI in the detection of neoplastic lesions is comparable to     chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent     Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is     achieved via the use of post hoc computer algorithms, applying different filters to the     stored endoscopic images and enabling a theoretically endless number of combinations of     filters that can be used. The Pentax I-scan system also allows post hoc modification of the     images. On the one hand, surface enhancement enables to better highlight mucosal changes.     Spectral modification allows to apply different modes in analogy with to FICE system.      These new imaging techniques have a theoretical advantage which is extendedly used for sales     purposes but has however so far not been proven in ulcerative colitis patients. We want to     test their clinical use in the screening for neoplastic lesions in patients with long     standing ulcerative colitis.   "
107261|NCT01882101|"     Until recently, there is no definite treatment for fecal incontinence that is proven to be     effective with low morbidity. The efficacy of biofeedback therapy for incontinence has not     been proven on the randomized controlled trials. Sacral nerve stimulation is too expensive     although some prospective studies showed the therapeutic potential. Recently, posterior     tibial nerve stimulation has been reported to be effective with lower cost in comparison with     sacral nerve stimulation. This study is designed to show the efficacy of posterior tibial     nerve stimulation compared with biofeedback therapy for fecal incontinence.   "
107254|NCT01882192|"     The primary research question is:      1) Does the planning condition improve adherence to regular physical activity compared to the     control condition at six months? Hypothesis: Adherence will be higher for the planning     condition in comparison to the more standard physical activity education condition. The     effect may wane over time from the initial measurement period but all outcomes will remain     significantly higher at six months.      Secondary Research Questions        1. Does the planning condition improve motivational, health-related quality of life, and          health-related fitness outcomes compared to the control condition at six months?           Hypothesis: The planning condition will not affect intentions or underlying motives          (theory of planned behaviour constructs) for physical activity because its effect on          behavior is to tie initial intentions better to behavioural action (i.e., behavioural          regulation) and not to enhance motivation. Health-related fitness and quality of life,          however, will be higher for the planning condition in comparison to the standard          physical activity education intervention condition. The effect may wane over time from          the initial measurement period but all outcomes will remain significantly higher at six          months in the planning condition compared to the standard physical activity education          group.        2. Can group differences among these motivational, behavioural, and health-related fitness          outcomes be explained through a mediation model? Hypothesis: The covariance of the          assigned conditions (planning, education) on use/adherence will be explained by planning          and use of behavioural regulation strategies (i.e., manipulation check). In turn, the          covariance between planning and behavioural regulation strategies and health-related          outcomes will be explained by physical activity adherence among conditions.        3. Can motivational variables predict adherence? Do these differ by condition?           Hypothesis: The approach will test Ajzen's theory of planned behavior, extended by the          concept of active planning. Affective attitude and perceived behavioural control will          predict intention, intention will predict planning and planning will predict adherence          across conditions.        4. Is there an intergenerational, seasonal, or gender difference across primary outcomes by          assigned condition? Hypothesis: Children will show greater adherence to the planning          condition than their parents. No differences in gender or season are hypothesized but          these are exploratory research questions because there is limited research at present to          make any definitive statement.   "
107273|NCT01881945|"     The aim of the study was to validate tools of physiological signal processing and     interpretation on healthy human volunteers in order to improve the understanding in     respiratory physiology and its interactions with heart function, and swallowing.   "
107274|NCT01881932|"     In this study the investigators will assess how useful and safe acupuncture is in easing the     pain, tingling and numbness that is caused by chemotherapy. The researchers hope this will     prevent the need to reduce the amount of chemotherapy a patient receives.   "
107255|NCT01882179|"     Heart attacks, or myocardial infarcts, are a major cause of death and disability in the UK.     Immediate unblocking of the obstructed heart vessel with a balloon catheter and implantation     of a mesh scaffold (stent) in heart centers is warranted in these patients. Morbidity and     mortality in this patient group is related to the infarct size. Therefore, there is a need to     discover novel therapeutic agents which reduce myocardial infarct size and preserve the     contractile heart function.      Large trials involving several thousand patients have demonstrated a survival benefit in     patients with impaired heart function due to a heart attack, who received a     mineralo-corticoid receptor antagonist (MRA, drug name: spironolactone). In these trials     patients received the drug late, 3-14 days after the heart attack.      Our proposal is to investigate whether MRA therapy administered intravenously prior to     unblocking an occluded heart vessel, can reduce infarct size and as such can prevent long     term sequelae of heart attacks.      150 patients admitted to 4 tertiary care hospitals (Heart Hospital London, London Chest,     Essex Cardiothoracic Center and Leeds General Infirmary) for heart attack will be randomly     assigned to receive MRA treatment or placebo. The first dose of the MRA will be applied     intravenously immediately in the catheter suite, even before re-opening of the occluded     vessel. From the second day on, patients will be prescribed oral MRA treatment, as a pill,     for a total of three months. Before hospital discharge and after three months, a magnetic     resonance image (MRI) of the heart will accurately investigate the evolution of infarct     (scar) size and the contractile heart function and compare the group of patients who received     the MRA drug versus the placebo control group. Of note, patients with an ejection fraction     <40% AND signs of heart failure OR diabetes will go on open label eplerenone according to     current guidelines, instead of the study drug.      This study will give first evidence, if very early MRA treatment improves heart function and     should be used as early as possible for treatment of patients after a heart attack.   "
107256|NCT01882166|"     The number of children conceived by assisted reproductive technology is increasing in Nordic     countries as well as worldwide. An important factor of success in treatment of infertility is     a short time to pregnancy with impact on both economical aspects for the society and     medical and psychological aspects for the couple. During treatment, success relies on 1)     optimal stimulation of growth and maturation of multiple follicles by administration of     exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo     with the highest potential of implantation to be transferred to the mother. In the present     project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant     FSH (Puregon®) will be compared. To this end early embryo development and kinetics after     fertilization will be evaluated. The system to be used is time-lapse recording of embryo     morphology during the first days of embryo development by means of an embryoscope. Aim of     this study is to investigate if Puregon and urinary Fostimon have different effect on embryo     quality. The hypothesis of the study is that stimulation of egg production by these two types     of follicle stimulating hormone does not have the same effect on early embryo quality.   "
107257|NCT01882153|"     The investigators will assess the efficacy of parent delivered interventions in the treatment     of social and communication deficits in children with autism. By collecting information about     parent and child functioning before and after intervention, the investigators will be able to     determine whether the intervention is effective in improving child social communication and     reducing parent stress.   "
107258|NCT01882140|"     The high incidence of burn injuries and mortality and morbidity as well as the high economic     impact associated with this type of injury justifying the need to develop new technologies     for the treatment of burn patients. Electrical stimulation for wound healing is a resource     that has been increasingly used in routine physical therapists, but has the disadvantage of     needing means of wet contact between the electrode and injury. The other resource used for     therapeutic healing is conventional electrical stimulation of low intensity for capacitive     field, a technique of physical therapy intervention not commercially available in Brazil.     This new technology seems to have significant physiological effects in tissue repair and has     been used for the treatment of chronic wounds which healed with difficulty. The objective is     to analyze the effects of electrical stimulation of low intensity for capacitive field in     healing skin burns. Patients from both genders aged over 18 years who have burns, will be     evaluated and treated at the Emergency Unit of the Hospital of the Faculty of Medicine of     Ribeirão Preto, University of São Paulo. The stimulation will be initiated within 24 hours     after surgery to perform the graft and will be held daily for 60 minutes during the patient's     stay or until complete healing of the skin. The electromagnetic field will be placed on the     care of the burned area and / or the donor skin graft, not interfering with departmental     procedures. Will be performed photographic record standardized wound by a digital camera, and     then quantified by a computer program. Expected to reduce the period of hospitalization and     thus lowering the cost of treatment, and the possibility of improving the quality of life of     patients.   "
107259|NCT01882127|"     The project was undertaking by Qilu Hospital of Shandong University in China. In order to     report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose     Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP),     compared to conventional high-dose dexamethasone therapy.   "
107260|NCT01882114|"     The prevalence of metabolic syndrome in patients suffering from non valvular atrial     fibrillation is derived from studies regarding recurrences of atrial fibrillation after     catheter ablation. Prospective studies in european countries are stil lacking. Furthermore     the impact of metabolic syndrome on cardiovascular events in patients with non valvular     atrial fibrillation is still unknown.   "
107283|NCT01881815|"     The objective of this study is to collect wound exudate (fluid) swab samples from Subjects     who have wounds that show clinical signs of infection, as well as from Subjects who have     wounds that do not show clinical signs of infection. Swab samples will be collected from     acute and chronic wounds of different etiologies and these will be analysed for bacteria     types and markers of infection.   "
107275|NCT01881919|"     The purpose of this study was to test the effect of chronic consumption of Quercetin 500 mg     tablets on blood uric acid and other biomarkers in adult males.   "
107276|NCT01881906|"     The aim of this study is to evaluate the effect of twelve weeks of a physical and     psycho-social program consisting of: supervised, structured exercise training in a group of     advanced lung cancer patients (cardio and strength training, relaxation training) twice     weekly. Primary outcome is (VO2peak). The hypotheses are that patients who undergo this     intervention will increase maximal oxygen uptake (VO2peak), strength (1RM), functional     capacity (6MWD) and quality of life (HRQOL) and reduce the level of anxiety and depression     compared to those who do not.   "
107432|NCT01879878|"     The goal of the POUDER trial is to determine the feasibility of a randomized controlled trial     regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin     in patients with advanced pancreatic ductal adenocarcinoma that receive palliative     chemotherapy.   "
107262|NCT01882088|"     Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly     decrease patients' quality of life due to the typical symptoms - heartburn and regurgitation.     These are caused by increasing number of transient lower esophageal sphincter relaxations,     regularly recurring reflux of gastric content into oesophagus, acidification of the esophagus     and consequent esophageal mucosa damage. In addition, an important role is played by the     increase in production of hydrochloric acid in the stomach, the slowdown in the evacuation of     the contents from the stomach and increase of gastric and intra-abdominal pressure. All of     these factors may depend on the patient's diet.      Theoretical premises of the positive influence of including dietary fiber on the course of     gastroesophageal reflux disease may be the fact that dietary fiber may absorb nitric oxide     (NO) containing in food, which in turn has relaxing effects on the lower esophageal     sphincter. In addition, fiber deficiency has been shown to be associated with increased     chance of developing hiatal hernia, which is associated with greater risk of the disease     manifestations. There is lack of data about diet modification with its enreaching by dietary     fibers and their type on the symptoms frequency and objective (i.e. esophageal pH-impedance     and manometric) parameters.      Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata     (isphagula, psyllium). High content of mucuses in the composition of psyllium seed allows it     to include to group of soft food fibers, which has fundamental value for the appointment of a     drug at a number of diseases, when, for example, the use of coarse food fibres not     recommended or contraindicated.      Mucofalk is the registered medicinal (registration number of the Russian State register of     medicines P N014176/01, registration date 14.07.2008, manufacturer: Lozan Pharma GmbH,     packager: Dr. Falk Pharma GmbH, Germany). Recommended dosage and administration: orally,     adults and children over 12 years - 1 pack. 2-6 times a day. Before use, the contents of 1     packet poured in a glass, in which slowly poured with cold water (150 ml), stir and drink     immediately. Then drink another glass of liquid.   "
107263|NCT01882075|"     The investigators want to test during anesthesia the feasibility of a closed-loop automated     fluid replacement system using cardiac output monitoring as the input value.   "
107264|NCT01882062|"     The purpose of this project is to study the efficacy of an anaplerotic treatment on brain     energy profile evolution at an early stage of the Huntington disease.   "
107265|NCT01882049|"     This study is to investigate the use the adjustable gastric band for the treatment of obesity     in adolescents.   "
107266|NCT01882036|"     The focus of this proposal is to define the mechanism by which bariatric surgery acutely     improves insulin sensitivity. Our central hypothesis is that drastically reduced caloric     intake early after Bariatric surgery improves the pro-inflammatory profile of macrophages,     which in turn improves insulin sensitivity and glucose homeostasis.   "
107267|NCT01882023|"     Currently, there is not a robust, testable neural model available that sufficiently explains     the development and maintenance of anorexia nervosa (AN) a severe, often fatal,     adolescent-onset eating disorder. Using state of the art neuroimaging and neuropsychological     techniques, our objective is to identify neural mechanisms in the adolescent brain underlying     AN. This is of high clinical relevance in as much as it will provide a robust platform for a     diagnostic battery so that physicians can identify those who are prone to develop AN at a     very early stage of life.      The aim of this research plan is: 1) To develop knowledge of cognitive dysfunction in     adolescents who have recently been diagnosed with AN, with a battery of cognitive tests     during a series of clinical visits. 2) To provide a scientific basis for our knowledge about     how the brain of an adolescent with an eating disorder differs from that of a healthy     adolescent, by conducting functional and structural magnetic resonance imaging on adolescent     females with AN.   "
107268|NCT01882010|"     The purpose of this study is to determine if Leukine (sargramostim) can be safely     administered to Parkinson's disease patients for an extended period of time (56 days) and     restore immune deficits seen in Parkinson's patients compared to controls. The development of     magnetoencephalography (MEG) as a monitoring tool for PD will also be explored. At enrollment     and repeating again at two 4-week intervals, whole blood from PD patients and controls will     be obtained for analyses and the results will be used to calculate immune response profiles     as a baseline for comparison after drug treatment. Physical examinations and motor     assessments will also be performed on PD patients. After the 8-week baseline data collection,     control participation will end and drug treatment of PD patients will begin. PD patients will     be randomized, and half will receive drug and half will receive placebo. Leukine at a dosage     of 6 µg/kg or saline as placebo will be administered by subcutaneous injection daily for 56     days (8 weeks). During drug treatment, PD patients will be monitored every two weeks by     physical examinations, motor assessments, and blood analyses. As follow-up, four weeks after     drug administration has stopped, subjects will again have physical examinations, motor     assessments, and blood analyses. MEG will be performed on PD patients and controls at the     start of drug treatment, and on PD patients at the end of the drug treatment period and 4     weeks after drug is stopped. In addtion, at the second cohort of 8 PD subjects, we will     evaluate the potential Leukine-induced motor control and mobility improvements. Also, levels     of the neurotransmitters glutamate, glutamine, serotonin, acetylcholine, GABA, norepinephrine     and epinephrine in serum/plasma will be analyzed to correlate with changes in motor function     and drug treatment.   "
107269|NCT01881997|"     Patients presenting with painful procedures in the Emergency Department (ED) have been shown     to frequently have inadequate pain management. The incision and drainage (I&D) of an abscess     is a common procedure that is viewed by many emergency physicians as only requiring a     localized anesthetic for pain management. However, it has been documented in previous     research that there can be disconnect between what emergency medicine physicians interpret as     painful and what patients experience as pain. A trial will be conducted to focus on use of     intramuscular (IM) Fentanyl as an intervention to help alleviate pain associated with the     incision and drainage of an abscess. This is a procedure that rarely receives systemic     opioids.      This double blinded protocol will randomize a total of 50 patients patients with abscesses to     receive either a combination of Fentanyl IM followed by subcutaneous (SC) local bupivicaine     analgesia or Normal Saline IM followed by SC local bupivicaine analgesia. Only opiate naive     patients will be enrolled. The primary outcomes studied are patients overall satisfaction     with procedure, and patients level of pain associated with the procedure.   "
107270|NCT01881984|"     This is a medical research study to test a medication in adult patients with a disease called     medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the     985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is     currently FDA approved for the treatment of urea cycle disorders. Previous research suggests     that Ravicti may also be effective in the treatment MCAD deficiency. This study will     investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD     deficiency caused by having at least one copy of the 985A>G mutation.   "
107271|NCT01881971|"     Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary     abnormalities in HIV.   "
107277|NCT01881893|"     The psychosocial development of adults with congenital heart disease (CHD) can be challenged     by many issues including family overprotection, impaired peer relationships, delayed     progression into independent adulthood, and difficulties with career and future planning.     One-third of patients have diagnosable mood or anxiety disorders and the prevalence of     depression is 3 times that of the general Canadian population. Unfortunately, most adults     with CHD and significant depression or anxiety do not receive mental health treatment.     Despite an increasing awareness of the unique psychosocial concerns of this patient     population by both health care providers and patients, there have been no interventions     targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative     research suggests that patients themselves are very interested in psychological services that     target their distinctive life experiences, are provided in a group setting, and emphasize     coping and resilience. The overarching aim of this proposal is to assess the feasibility of a     full-scale randomized controlled trial of a group intervention aimed at improving the     psychosocial functioning, quality of life, and resilience of adults with CHD.   "
107278|NCT01881880|"     Study Rationale: an accurate breast cancer staging has a great impact in the management of a     breast cancer. MRI is considered as the most sensible exam for this staging. However it has a     low specificity and it may result in extra testing and stress for the patient, add to costs,     and delay treatment. By contrast, Tomosynthesis is performed during the same time than     mammography and has a good specificity. Although this modality is very promising, it has not     been assessed in a population of consecutive patients.      Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode     (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of     additional multifocal, multicentric, and contralateral cancers.   "
107279|NCT01881867|"     This randomized phase II trial studies how well glycosylated recombinant human interleukin-7     (CYT107) after vaccine therapy works in treating patients with castration-resistant prostate     cancer that has spread to other areas of the body or has not responded to at least one type     of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may     stimulate the immune system in different ways and stop tumor cells from growing. Vaccines     made from white blood cells mixed with tumor proteins may help the body build an effective     immune response to kill tumor cells. It is not yet known whether glycosylated recombinant     human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.   "
107280|NCT01881854|"     The hypothalamus is a part of the brain containing a number of nuclei with a variety of     functions. It is central in the regulation of hormone secretion, sleep, and circadian     functions. The suprachiasmatic nucleus of the hypothalamus is a key component in controlling     circadian rhythms and generates the rhythm of melatonin secretion from the pineal gland and     cortisol secretion. Both melatonin and cortisol are involved in the regulation of circadian     rhythms and sleep.      Craniopharyngiomas are a type of brain tumors that usually affect the hypothalamus     indirectly. In general, they are locally aggressive invading crucial structures e.g. the     hypothalamus, the pituitary, and the optic nerve. Compared to healthy controls,     craniopharyngioma patients have previously been reported with impaired quality of life,     increased self-reported general and physical fatigue, increased daytime sleepiness, and     increased prevalence of severe sleepiness      Damage to the hypothalamus by local tumour or its treatment might involve the suprachiasmatic     nucleus and thereby melatonin secretion leading to disturbed circadian function causing     clinical manifestations in terms of daytime sleepiness and fatigue.      The investigators aimed to assess the influence of craniopharyngiomas or their treatment on     melatonin secretion, and the association with sleep pattern, sleep quality, fatigue, and     sleepiness.      15 patients with craniopharyngioma and 15 gender, age, and BMI matched healthy controls were     included. Salivary melatonin and cortisol were measured over a 24h-period. Sleep-wake     patterns were characterized by two weeks of actigraphy recordings and sleep diaries.     Sleepiness, fatigue, sleep quality, and general health were assessed by questionnaires.   "
107281|NCT01881841|"     The goal of this project is to evaluate the feasibility, acceptability, and effect size of a     new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved     adolescents in primary care.   "
107282|NCT01881828|"     The objective of the proposed research is to evaluate the efficacy and safety of the use of     metformin in addition to standard insulin therapy in overweight and obese children and     adolescents, age 12-<20 years, with type 1 diabetes for at least 1 year. Secondary objectives     are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is     still being produced by the beta cells of the pancreas, and on vascular dysfunction. In     addition, an ancillary study is planned to assess if metformin will improve tissue-specific     insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.   "
107285|NCT01881789|"     Phase 1b:        -  To establish the maximum tolerated dose (MTD) of oprozomib and dexamethasone          administered in combination with lenalidomide or oral cyclophosphamide        -  To evaluate the safety and tolerability of oprozomib and dexamethasone administered in          combination with lenalidomide or oral cyclophosphamide      Phase 2:        -  To estimate the overall response rate (ORR) and complete response rate (CRR)        -  To evaluate the safety and tolerability of oprozomib and dexamethasone administered in          combination with lenalidomide or oral cyclophosphamide      Secondary Objectives:        -  To evaluate population pharmacokinetic (PK) parameter estimates of oprozomib and          variability in these estimates when administered in combination with dexamethasone and          lenalidomide or oral cyclophosphamide        -  To estimate the duration of response (DOR)        -  To estimate progression-free survival (PFS)   "
107286|NCT01881776|"     The investigators undertook this prospective, randomized trial to compare the recovery     profile throughout the first postoperative week in patients receiving continuous (CISB)     interscalene brachial plexus block, single injection (SISB), or general anesthesia (GA) for     arthroscopic rotator cuff repair surgery. Specifically, the effects of the three anesthetic     techniques when used intraoperatively as a sole anesthesia modality were studied on     postoperative pain, time-to-first pain, analgesic consumption, fast-tracked PACU bypass rate,     length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects. The     investigators hypothesized that CISB results in a superior postoperative recovery profile as     compared to SISB or GA alone.   "
107287|NCT01881763|"     The study aims to compare outcomes of Electroconvulsive Therapy (ECT) using ketamine versus     methohexital anesthesia in depressed patients. The investigators hypothesize that patients     who receive ketamine anesthesia during ECT will achieve remission status faster than those     receiving methohexital anesthesia. Also, at the end of the ECT course subjects will display     fewer cognitive side effects compared to those treated with methohexital anesthesia.   "
107288|NCT01881750|"     This is a research study examining the effectiveness of pivotal response treatment group     (PRTG) in targeting language skills in young children with autism. Research has demonstrated     that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements     in the core symptoms of autism. The purpose of this study is to further examine the     effectiveness of teaching pivotal response treatment to parents of children with autism in a     group format. To determine the effectiveness of pivotal response training group (PRTG) it     will be compared to another parent education group by conducting a randomized controlled     12-week trial.   "
107289|NCT01881737|"     This study will assess the tolerability and effectiveness of pregnenolone in the treatment of     behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone     found in the body which has been shown to help with the function of nerve cells. It is also     shown to modulate the activity of certain brain receptors implicated in autism. We hope to     examine the tolerability of pregnenolone in adults with autism.   "
107290|NCT01881724|"     This is a randomized controlled trial with 12 month sleep education as intervention, followed     by a 12 month observational period, to study whether sleep education would improve glycemic     control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate     the neurohormonal changes associated with sleep education.   "
107291|NCT01881711|"     Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP)     testing results can be used in conjunction with imaging to diagnose shunt patency or     obstruction in pediatric/adolescent subjects presenting to an Emergency Department or     Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic     methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be     compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction     confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency     confirmed in surgery.   "
107292|NCT01881698|"     Establishment of a range of normal values in pregnancy with the Multiple Electrode     Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet     count but platelet function. This has not been studied in ths special patient group. Results     from this trial will be used as a basis for further investigation of abnormal platelet     function in pregnancy.   "
107293|NCT01881685|"     The objective of the study is to evaluate the association between certain markers in the     blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the     device under study.   "
107294|NCT01881672|"     Inhalation is a common condition in patients with impaired their awareness requiring     protection of the upper airway by endotracheal intubation. This inhalation may lead to     chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration     of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of     mechanical ventilation and length of ICU stay increased. However, the proportion of patients     with such bacterial pneumonia, bacterial ecology and morbidity that are little known.      The aim of this study is to determine the frequency of bacterial pneumonia in patients     admitted to the ICU for coma and treated with mechanical ventilation   "
107295|NCT01881659|"     HPV testing for primary cervical cancer screening of women over 30 years of age is likely to     become the standard of care in the near future in many areas of the world. Its high     sensitivity can significantly improve the effectiveness of screening programs and its     prolonged negative predictive value can allow extension of screening intervals. However, a     single HPV test has low positive predictive value and can lead to unnecessary workup and     over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000     women with HPV testing and compare several triage approaches that can follow HPV testing in     order to make an HPV-based screening programme efficient, affordable and sustainable.   "
107296|NCT01881646|"     The main purpose of this study is to assess the induction of neuroinflammation in brain     regions of interest for learning and memory in adult patients undergoing urological surgery     under general anesthesia   "
107297|NCT01881633|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.   "
107366|NCT01880736|"     This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and     safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin     degludec in inadequately treated subjects with type 2 diabetes.   "
107298|NCT01881620|"     Hypothesis:      The investigators would like to demonstrate that diagnosis performance of PET/CT scan without     and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced     CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot     study given the few available data concerning this imaging exam reproducibility.      This study is a prospective single center study.   "
107299|NCT01881607|"     This is a community essay to assess the effectiveness of a multi-level (individual, family,     and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a     population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools     were assigned to the intervention or the controlgroup at random. The investigators assessed     SHS exposure in different settings (at school, at home, on transportation and leisure time)     and tobacco consumption by means of a questionnaire before and one year after the     intervention. Based on a previously evaluated intervention to prevent smoking initiation     (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program)     including two new activities to prevent passive smoking to be applied at three levels: in the     classroom (pupils), at the school (pupils, teachers, and parents), and in the family (pupils     and parents).   "
107300|NCT01881594|"     The aim of this study is to compare postoperative ileus between stimulated and unstimulated     patients prior to ileostomy closure.   "
127713|NCT01613391|"     This study aimed to measure, compare apelin, resistin, visfatin levels in patients underwent     to RYGBP, LAGB and their relation with obesity.   "
107302|NCT01881568|"     The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to     reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to     estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through     serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled,     randomized, double blind clinical trial that compare efficacy and safety of topical TA versus     intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).   "
107303|NCT01881555|"     The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2     therapeutic strategies, one based on coronary angiography guidance and the other based on     coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery     disease patients.      The trial is a prospective, multicenter, French, randomized clinical trial including men and     women ≥ 18 years presenting with significant multivessel disease defined by coronary     angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic     vessels. The patients who give their informed consent will be randomly assigned to a     therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the     FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this     multivessel evaluation (angiography or FFR), the investigator will choose the best     therapeutic strategy to his discretion (medical optimal treatment, coronary stenting,     coronary artery bypass graft surgery). The aim of revascularization procedures will be to     obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be     treated.      The primary end point of the trial is a composite of major cardiovascular events including     death from any cause, myocardial infarction, any hospitalization for coronary     revascularization performed in addition to initial treatment and stroke at 1 year of     follow-up.      Secondary end points will include adverse events, individual major cardiovascular events,     stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's     quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.   "
107304|NCT01881542|"     Background and project rationale:      Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and     constitutes a leading cause of maternal morbidity and mortality. Preeclampsia is liable to     endanger the lives of both the gravida and the fetus, particularly if treatment is initiated     inappropriately or in an untimely fashion.      Diagnosis of preeclampsia is dependent on the finding of proteinuria, determined as being     over 300mg of protein in a 24 hours urine sample. However, urine collection spanning 24 hours     sometimes constitutes a bottleneck, extending the time to diagnosis of preeclampsia.     Additionally, the collection of urine for 24 hours entails a degree of discomfort, requiring     that the woman be in proximity to for collection vessel, and increases the length of her     hospital admission.      The use of an abbreviated test may permit diagnosis and treatment in a more timely fashion.     Similarly, the ability to exclude the diagnosis more rapidly could reduce length of hospital     stay and consumption of the health system's limited resources. Further, a shorter test may     reduce the discomfort associated with the 24-hour test and thus increase compliance.      Previous research has suggested that briefer tests correlate with the traditional 24 hour     urine collection, however these studies were based on small study populations.      Research Objective:      To validate a brief and rapid test for the diagnosis of urinary protein excretion.      To assess whether, in women with suspected preeclampsia, a difference exists between protein     excretion during the daytime and at night.      Methods:      Urine collection will be performed on pregnant women admitted for investigation of suspected     preeclampsia, with volumes recorded and samples taken at 6, 12 and 24 hour intervals for     assessment of urinary protein content. As such, a comparison will be made between the protein     excretion after 6 and 12 hours with that over a full 24 hour period; in addition, comparison     will be made between daytime and nighttime urinary protein excretion. The results will allow     for assessment of whether a shorter test can substitute the full 24 hour collection in the     diagnosis of preeclampsia; results of women who are shown to not suffer from preeclampsia     will be used to assess whether a short test can rule out the disease. Additionally a urine     sample for protein/creatinine ratio will be examined and correlated with results of the     different collection periods.   "
107305|NCT01881529|"     To treat patients with scleroderma by blocking the expression of LOXL2. The investigators     first need to confirm (through observation) that LOXL2 is overexpressed in disease.   "
107306|NCT01881516|"     we plan to conduct this trial to find out：        -  If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or          radio-therapy？        -  How about the extent it relieves？the safety and applicability ？        -  What's the possible influential factor and mechanism ？   "
107307|NCT01881503|"     The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to     patients with life-threatening anemia for whom blood is not an option.      HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen     carrier in South Africa and Russia.   "
107308|NCT01881490|"     The overall objectives of this study are to develop two indices capable of measuring     intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's     disease by means of Magnetic Resonance Imaging with Enterography protocol (MRE) and pelvic     MRI.   "
107380|NCT01880554|"     Hypothesis: Use of contrast ultrasound showed interesting results, which can increase     ultrasonography sensitivity performed during surgery in the evaluation of operable liver     metastases.      This study is a two-stage phase II multicenter study (Simon's two-stage).   "
107309|NCT01881477|"     CONTEXT: The physical deconditioning in the critically ill patient is favored by prolonged     immobilization, which compromises the ability to function. This perpetuates the stays in     hospital and intensive care units (ICU). To combat this, there physiotherapy intervention     methods that can reverse or reduce their occurrence.      OBJECTIVE: The purpose of this research is to determine the effects of passive movements,     assisted active and resisted, and changes of position on grip strength, joint mobility and     functional capacity in patients in ICU.      METHODS: A quasi-experimental intervention, before and after, no control group, in which 40     patients in an adult ICU in Medellin, receive physiotherapy care. Electrogoniometry,     dynamometry and functional independence measure, will be made before the intervention and     serial assessments every four days, until discharge from ICU.   "
107310|NCT01881464|"     Study hypothesis - this study will assess the presence of endothelial dysfunction in patients     with Crohn's disease before and after 12 weeks treatment of anti TNF α.   "
107311|NCT01881451|"     The purpose of this study is to use 18F-EF5 PET/CT scans to locate areas with low oxygen     levels (hypoxia) in patients with recurrent and/or metastatic cancer.   "
107312|NCT01881438|"     The purpose of this study is to assess the association of retinal detachment (separation of     the retina [the innermost layer of the eyeball] from its connection at the back of the eye)     with exposure to oral ciprofloxacin or oral fluoroquinolones.   "
107313|NCT01881425|"     Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular     pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled     when using maximum tolerated glaucoma medications.   "
129779|NCT01586403|"     This is a phase one trial to determine if genetically engineered lymphocytes can be safely     delivered to patients with metastatic melanoma.   "
107314|NCT01881412|"     Many children have asthma and this causes problems with their health. A lot of children with     uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place     for an intervention for these children. One intervention is prescribing inhaled steroids to     children with uncontrolled asthma, but currently this is rarely done in the emergency     department. Inhaled steroids have been shown to be good at making children better long-term     when they have uncontrolled asthma.      This study identifies children in the emergency department with uncontrolled asthma using a     tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children     meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine     asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled     corticosteroid from the emergency department. The investigators hypothesize that children who     are prescribed inhaled steroids for uncontrolled asthma from the emergency department will     have better 6 month asthma control than children who receive routine asthma care.   "
107315|NCT01881399|"     The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic     cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may     be severe ranging from intraoperative repair to liver transplant or patient's death.     Different techniques have been proposed to prevent BDI.      Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary     tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:        1. ease of use        2. lack of invasiveness        3. absence of ionizing radiation to the patient and the operating staff        4. performed prior to any dissection (prior to critical view of safety)      Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI     images) to guide biliary tree anatomy visualization will be also evaluated in this study.      The study requires a 2-month patient participation.   "
107316|NCT01881386|"     This project is designed to investigate whether measurements of lactate in tumours, made     using a magnetic resonance technique similar to MRI, is an effective non-invasive method to     detect whether some new targeted drugs are having their desired effect.      The study hypothesis is that by using magnetic resonance spectroscopy techniques, we will be     able to observe changes in tumour lactate levels in vivo, in response to treatment.   "
107317|NCT01881373|"     The goal is to build social/cultural, political/economic, and physical/built environments     that will promote active play and intake of healthy food to prevent young child obesity in     the Pacific Region. Our methods will support local culture in order to achieve this goal in     these remote, underserved native populations. CHL will engage the community, and focus on     capacity building and sustainable environmental change.      The focus of the CHL community-based program is to promote healthy eating and to increase     physical activity. In order to demonstrate effectiveness, the investigators will recruit and     measure children in six communities selected in each of our jurisdictions in the Pacific.     These represent intervention communities, comparison communities, and temporal communities.   "
107318|NCT01881360|"     Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac     disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic     celiac disease or non-celiac gluten intolerance. The objective of this study is to compare     the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and     celiac-type symptoms.   "
107319|NCT01881347|"     The present study is designed to test the hypothesis that resveratrol supplementation will     improve the function of the endothelium in patients with type 2 diabetes mellitus.      The function of the endothelium will be tested with a non-invasive technique that uses     ultrasound to measure the amount of dilation that occurs in the brachial artery following     5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also     collect blood, urine, and cell samples and test the effects of treatment on protein     expression, nitric oxide production, and function of mitochondria.   "
107320|NCT01881334|"     The objective of this study is to make T-cell depleted stem cells from a family member who is     a half match (haplo-identical) available on an expanded access basis to patients receiving     one or two unrelated cord blood transplants who are at a higher risk of not engrafting in a     safe amount of time. The purpose of the related stem cells is the give the bone marrow a     jump start towards recovery. Ultimately, the cord blood cells will grow and permanently     rescue the bone marrow.   "
107367|NCT01880723|"     Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion     regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol     on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in     CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC     chloride.   "
107321|NCT01881321|"     Study design: This is a 2-phase study. During the first phase, the investigators developed a     contraceptive counseling intervention based on the principles of Motivational Interviewing,     trained counselors, and conducted a small pilot study to develop skills and refine the     intervention.      The second phase is this feasibility randomized controlled trial (RCT) to compare outcomes     between:      Group 1 - Women randomized to a 20-40 minute contraceptive counseling session based on the     principles of motivational interviewing, vs.      Group 2 - Women receiving usual clinic care.      Population: Women, aged 15-29 years, presenting to the University of Chicago family planning     clinic for termination of an unintended pregnancy.      Hypothesis: A larger proportion of women who are randomized to receive the MI counseling     intervention will be using very effective contraception 3 months after the intervention.   "
107342|NCT01881048|"     The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil     capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC).     Short-term intervention with anti-inflammatory medications will demonstrate a reduction in     the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential     in PABC. This unique window in breast cancer management serves as a valuable opportunity to     obtain preliminary data on biomarkers and the alterations that occur when the system is     troubled by a drug or other intervention which will be instrumental in designing future     therapeutic or preventative strategies for larger clinical study.   "
107343|NCT01881035|"     The study is designed to investigate the efficacy of renal nerve denervation in treating     drug-resistant hypertension in patients with end stage renal disease.   "
107322|NCT01881308|"     The purpose of this study is to assess the effect of disease-modifying anti-rheumatic drugs     (DMARDs) dose reduction in patients with rheumatoid arthritis (RA).      Remission is the treatment target in RA, but knowledge about the best way to treat RA     patients who achieve sustained remission is limited. DMARDs have potential serious adverse     events, and biologic DMARDs are costly to the society. The objectives for ARCTIC REWIND are     to assess the effect of tapering and withdrawal of DMARDs on disease activity in RA patients     in sustained remission, to study predictors for successful tapering and withdrawal of DMARDs     in this patient group, and to study cost-effectiveness of different treatment options in RA     remission.      ARCTIC REWIND is a randomized, open, controlled, parallel-group, multicenter, phase IV,     non-inferiority strategy study. Patients with less than five years of disease duration and     stable remission for at least 12 months are randomized to either continued stable treatment     or tapering and withdrawal of DMARDs, including tumor necrosis factor (TNF) inhibitors and     synthetic DMARDs. Patients are assessed by clinical examination, patient reported outcome     measures, ultrasonography, MRI and X-ray, and monitored for adverse events. The primary     endpoint of the study is the proportion of patients who are non-failures (have not     experienced a flare) at 12 months. Secondary endpoints include composite disease activity     scores and remission criteria, joint damage and inflammation assessed by various imaging     modalities, work participation, health care resource use and health related quality of life.   "
107323|NCT01881295|"     This study is designed to compare the effect of sources of potassium on uptake and the effect     of potassium on blood pressure.   "
107324|NCT01881282|"     The purpose of this study is to compare the therapeutic effect and safety of compound     carraghenates cream with Mayinglong musk hemorrhoid (swollen veins in the lower part of the     rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of     pain.   "
107325|NCT01881269|"     The purpose of this study is to evaluate the performance of the software that calculates     respiration rate for the study pulse oximetry monitoring system during transitions of     ventilation type from spontaneous breathing to controlled ventilation.   "
107326|NCT01881256|"     This is a longitudinal, observational study on nutrition, growth and body composition in     preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm     period by investigating associations between macronutrient supply, growth, and body     composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.   "
107327|NCT01881243|"     The broad objective of this study is to test the association between hyperoxia exposure after     resuscitation from cardiac arrest and outcome. Our overarching hypothesis is that hyperoxia     after ROSC is associated with increased oxidative stress and worsened neurological and     cognitive outcomes.   "
107328|NCT01881230|"     The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in     combination with either gemcitabine or carboplatin to the combination of gemcitabine and     carboplatin as first line treatment in female subjects with triple negative metastatic breast     cancer (TNMBC) or metastatic triple negative breast cancer.   "
107329|NCT01881217|"     An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety,     tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of     BAY1179470 in subjects with advanced, refractory solid tumors   "
107330|NCT01881204|"     The primary objective of this clinical trial is to test hesperidin with and without     CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary     objective is the comparison between 41Ca technology and classical biomarker to evaluate bone     resorption.   "
107331|NCT01881191|"     This study will evaluate the effects of Aubagio on changes in the brain using MRI.   "
107332|NCT01881178|"     This study has been developed to investigate the anti-inflammatory effects of a commercial     product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research     method employs a double blind, placebo controlled, and time-series (repeat measures) design     with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation -     testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12 weeks     (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is expected     that baseline CRP levels in healthy participants will decline.   "
107333|NCT01881165|"     This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract     infections (UTIs) in women who consume it. About 150 adult women will participate in this     study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or     a placebo for 12 months. We expect cranberry supplement to have better results than the     placebo. Subjects will not know which supplement they are taking. The primary outcome is the     number of UTIs over 12 months.   "
107334|NCT01881152|"     The starting hypothesis is that a multilevel educational campaign, specifically developed for     the local community, can increase public stroke awareness and reduce pre-hospital delay.      The effectiveness of such intervention will be evaluated according to a cluster randomized,     stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord,     AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the     patients consecutively admitted to the six participating hospitals throughout the study     period, for suspected stroke or transitory ischemic attack (TIA).   "
107335|NCT01881139|"     The purpose of this study is to monitor the impact of exercise training on cardiac functions     and lipoprotein lipids.   "
148078|NCT01346033|"     The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of     subjects who have been diagnosed with Type 2 diabetes.   "
107340|NCT01881074|"     Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the     most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite     conventional medical treatment, some diabetic patients do not seem to be able to reach     desirable metabolic control. This is a double-blinded, randomized study investigating the     effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response     to periodontal treatment in type II diabetic patients with periodontal disease. The     investigators believe that using triclosan containing toothpaste during periodontal treatment     will decrease the local inflammatory response and that this reduction will improve     periodontal status and metabolic control.   "
107341|NCT01881061|"     The purpose of this study is to evaluate the role of lung sonography during different PEEP     settings in ICU patients with ARDS.   "
107344|NCT01881022|"     Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire,     decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus     adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that     many couples experience sexual distress following breast cancer, very few interventions have     been designed exclusively to address these concerns. The purpose of this study is to develop     and evaluate an online psychosexual program geared to the unique needs of couples     experiencing sexual distress after breast cancer. This study will utilize a web-based     approach, allowing couples to participate in the program from the privacy and comfort of     their homes, and providing a resource to couples who may not otherwise be able to readily     access support. Accordingly, this project has the potential for widespread positive impact     for couples affected by breast cancer.   "
107345|NCT01881009|"     To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a     closely monitored 12 hour overnight inpatient study. Once the safety of the device has been     validated we will move the study to an outpatient diabetes camp setting. The camp setting     will allow us to obtain pilot efficacy and safety data in a real-life environment.      We plan to compare the subject control nights to the subject nights on the OCL system to     assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on     previous research, we anticipate that the use of the OCL system will contribute to a greater     percentage of sensor glucose readings in the target range.   "
107346|NCT01880996|"     Oncologic patients often report increased fatigue during and after chemotherapy. Evidence     suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated with     chemotherapy. Previous studies, mostly performed in a population of breast cancer patients,     have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of life (1),     reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb) (3), and     reducing inflammation (4).      The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and     fatigue in patients with gynecological malignancies, particularly in patients with ovarian     cancer.   "
107347|NCT01880983|"     The purpose of this study is to identify the biochemical/genetic defects in erythropoietic     protoporphyria (EPP). People with EPP have skin sensitivity to sunlight and occasionally     develop liver disease. In this study, the investigators hope to learn the nature of the     biochemical/genetic defects in EPP because this may help explain the severity of these     clinical features.   "
107348|NCT01880970|"     The aim of this trial is to test the efficacy of an infant formula containing synbiotics on     the prevention of gastro-intestinal infections.   "
107349|NCT01880957|"     The primary aims of this study are to:        1. Quantify serotonin transporter (5-HTT) binding potential (BP) in vivo in bipolar          disorder patients (BPD) during a major depressive episode (MDE).        2. Assess the effect of lithium treatment of bipolar disorder on 5-HTT.        3. Assess the effect of lithium treatment of bipolar disorder on 5-HT1A BP.        4. Assess the effect of lamotrigine treatment of bipolar disorder on 5-HTT and 5-HT1A BP.        5. Assess the effect of lithium treatment of unipolar depression on 5-HTT BP.   "
107350|NCT01880944|"     Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation     spinal trauma.      However, the role of contrast enhancement has not investigated in patients with spinal     trauma.      Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI     for spinal trauma W/U clinically.      The study hypothesis is that there is no additional gain in addition of contrast enhanced     study to routine non-contrast MRI.   "
107351|NCT01880931|"     To find out the effect site concentration of remifentanil for preventing QTc interval     prolongation during intubation under propofol-remifentanil anesthesia in normotensive and     hypertensive patients   "
107352|NCT01880918|"     The proposed study is a post marketing, observational, retrospective data collection intended     to gather and record data on patients treated with the ColonRing device in routine clinical     practice at 4-6 centers. The data will assist in future evaluating the performance of the     ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior     Resection procedures.      Hypothesis: The performance of the ColonRing, determined by the rate of complications, will     be within the acceptable range reported in the literature for alternative treatment     modalities.   "
107353|NCT01880905|"     Ovarian torsion is one of the gynecological emergency. This complication requires high     clinical suspicion and early detection, to prevent permanent loss of ovarian function. The     long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure     the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the     length between the torsion group and other non torsion patients   "
107355|NCT01880879|"     research topic:helios After registration of clinical research bidders:kinhely bio-tech Co.Ltd     study design:A prospective single treatment group multicenter clinical study Number of     patients:Included in the subjects of 800 cases Main research purpose:Evaluation of safety and     effectiveness Mainly studies the finish:1 year target lesion of the failure      Inclusion criteria :      one:Gender not limited at the age of 18 to 80 two:myocardial ischemia or angina symptoms of     coronary artery disease three:A narrow is less than 50% treated with stents four:Comply with     the instructions five:Voluntarily signed the informed consent form exclusion criteria:     one:Pregnant women two:cardiac shock three:Against a suppository medicines or allergies     four:Participated in other test research in the first 6 months five:Within 6 months after PCI     plans to accept non cardiac surgery six:Non-compliant patient Follow-up time:A month for 6     months and 9 months to 1 year to 2 years follow-up progress plan:All center within 6 months     after start of complete into the group   "
107369|NCT01880697|"     The present study is designed to confirm the safety and immunogenicity of cell-derived,     trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years     and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by     Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days     post immunization. The vaccine composition will be based on the WHO-recommended influenza     strains for the 2013/2014 Northern Hemisphere vaccine. The results of this study are intended     to support the use of this vaccine in future influenza seasons if the recommended vaccine     composition remains the same, in compliance with the requirements of the current EU     recommendations for clinical trials related to yearly licensing of influenza vaccines.   "
107356|NCT01880866|"     Pulmonary arterial hypertension (PAH) is a progressive disease that results in severe     activity limitation and death. There are few treatments for PAH and the available medications     are expensive, difficult to administer and have significant toxicities.      (-)-Epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and     chocolate. Clinical intervention studies using dark chocolate in normal volunteers and     subjects at risk for or with established cardiovascular disease have demonstrated     improvements in peripheral and coronary vascular endothelial function, blood pressure,     lipids, glucose tolerance and inflammatory markers.      Our study intends to examine the hemodynamics effects of purified (-)-epicatechin in subjects     with pulmonary arterial hypertension. We hypothesize purified (-)-epicatechin will reduce     pulmonary vascular resistance in patients with pulmonary arterial hypertension.   "
107357|NCT01880853|"     Early detection of breast cancer through screening has been a common practice in the United     States and several European countries for decades.It is effective in reducing the mortality     of breast cancer and improving the postoperative quality of life of patients. Mammography has     been the standard imaging method for the screening, and in recent years, a supplemental     ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed     to define an optimal screening strategy that suits Chinese women and the socioeconomics of     China.   "
107358|NCT01880840|"     The purpose of this study is to compare the safety of 2 different doses of the     investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of     allergic rhinitis (AR). This is an open-label study; that is, parent and child will know     which group each is in.   "
107359|NCT01880827|"     Obesity is a worldwide problem and leads to multiple metabolic and endocrinological problems.      Bariatric surgeries are a growing field as a treatment choice for morbid obesity (BMI > 35     kg/m2). Clinical and research evidence shows that shortly after RYGB, T2DM resolves with     improving glucose tolerance. Foregut hypothesis behind bariatric surgeries postulate, that     bypassed portions of intestine contain a substance, that acts as an anti-incretin, ie. to     counteract metabolically favourable incretins. In view of the recent studies, it may be that     GIP is really the anti-incretin behind this hypothesis.      The current study is conducted to investigate the vasoactive roles of the GIP. The     investigators aim to show that GIP is the major contributor to the blood flow and tissue     blood volume observed in postprandial state.   "
107360|NCT01880814|"     The purpose of the study is:        1. To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the          long-term goal of developing a personalized treatment for child depression.        2. To collect pilot data on ways to personalize treatment for child depression using          cognitive behavioral therapy (CBT), caregiver-child treatment, or both.   "
107361|NCT01880801|"     The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic     purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of     healthy mothers.      In order to prevent severe thrombocytopenia in infants born to mothers with ITP.   "
107362|NCT01880788|"     The study will be designed as a case control evaluation to compare the genetic profiles of     three groups of patients categorized according to diagnosis.      Group 1 - CNV secondary to CSC Group 2 - CSC without CNV Group 3 - CNV secondary to advanced     AMD.   "
107363|NCT01880775|"     In this prospective randomized study the investigators aimed to investigate difference of the     duration of spinal anesthesia, discharge times and efficacy between low dose heavy     Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.   "
107364|NCT01880762|"     Developing an MRI protocol at 1.5 T allowing quantification of the hematopoietic, fatty and     trabecular moieties of marrow. An ideal protocol would differentiate red marrow from     neoplastic cellular infiltration, and detect loss of trabecular bone. This study assesses the     feasibility of a multiple gradient echo sequence for differentiation of water and fat     constituents of marrow, combined with T2* mapping to interrogate the trabecular component The     investigators hypothesize that these techniques will allow better identification of lesion     type than routine MR sequences, and can be used to quantitatively characterize myelomatous     marrow replacement, with iliac crest biopsy (which is routinely performed in the diagnosis of     myeloma) as gold standard.      Fluoro-deoxyglucose (FDG)/PET CT imaging can detect FDG uptake in active myeloma and is     obtained routinely for certain cohorts of patients with myeloma. PET/CT is commonly used in     both initial whole body assessment and in monitoring remission. PET has been found to be     about 59% sensitive and 75% specific for detection of myeloma .      Myelomatous lesions are detected on MRI by the replacement of marrow fat. Routine MRI however     is limited by scope/field of view, usually evaluating marrow in a single anatomic region     (such as an extremity, the pelvis or spine). To assess the diffuse marrow involvement in MM,     whole body MRI imaging potentiates near global assessment of the marrow, which aids in     evaluating tumor burden, and may be useful in staging.   "
107365|NCT01880749|"     The primary objective is to estimate the proportions of vestibular schwannomas (VS) and     meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as     determined by immunohistochemistry. This is a phase 0 PK (pharmacokinetic) and PD     (pharmacodynamic) study of RAD001 in patients with Neurofibromatosis Type 2-related and     sporadic VS and meningiomas. Enrolled patients will take RAD001 prior to a scheduled VS or     meningioma surgery, and blood and tissue samples will be obtained for further analysis.   "
107368|NCT01880710|"     319 Women undergoing hysterectomy for benign (not cancer) indications were randomly allocated     to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15 years ago.     They were followed by questionnaire at time of surgery and up to 5 years (not yet published)     after the surgery and evaluated regarding following outcomes: Urinary incontinence, pain,     bowel problems, per and postoperative complications, sexuality, quality of life, pelvic organ     prolapse and vaginal bleeding. Now the investigators are conducting a 15 year follow up with     the same out-come measures but also including physical examinations regarding Urinary     incontinence, voiding difficulties, pelvic organ prolapse and problems with the cervix. The     investigators' hypothesis is that several of the out-come measures will be present in more     cases than earlier due to age and menopausal changes. The investigators expect more urinary     incontinence in the subtotal group as this was seen at earlier follow ups. The investigators     expect to find more women with pelvic organ prolapse with the physical examination than by     questionnaire alone, possibly with a higher incidence in the subtotal group.   "
107370|NCT01880684|"     The aim of this study is to evaluate the correlation of capnography with non-invasive     measurement of cardiac output with the FloTrac/EV1000 following a reversible fluid challenge,     a passive leg raising maneuver, using thermodilution as the gold standard.      The main hypothesis is a correlation of 0.8 between the increasing of ETCO2 and the     increasing of ejection volume measured by FloTrac/EV1000 following a passive leg raising     maneuver.   "
107371|NCT01880671|"     The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of     migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks,     and presence of a preventive effect post treatment.   "
107372|NCT01880658|"     RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for     resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is     high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy     with capecitabine is still unknown.      PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy     followed by maintenance therapy with capecitabine to see the efficacy and safety, then to     investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV     colorectal cancer.   "
107373|NCT01880645|"     The goal of this clinical research study is to learn if it is feasible to use find (using     ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine     lymph node surgery.      In standard care, all affected lymph nodes are removed. In this study, however, the cancerous     lymph nodes will be removed separately and then the rest of the lymph nodes under the arm     will be removed after that.   "
107374|NCT01880632|"     1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or          cT4aN+M0);no previous chemo or radio therapy.        2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.           Secondary objectives:             -  The progression free survival (PFS) in the perioperative treatment of locally               advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);             -  percentage of pathological response ; percentage of grade 3 or 4 adverse events as               safety profile of perioperative treatments;             -  D2 resection -rate after neoadjuvant chemotherapy of XELOX;             -  Overall survival;             -  QOL during the whole period of treatment.        3. Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate          the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative          treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.        4. Treatment plan:Patients will be given the perioperative chemotherapy as below once          recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow:          Capecitabine 1000 mg/m2 ，bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1          week)Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks.        5. Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of          gastric operations in China, more than 500 per year.   "
107375|NCT01880619|"     This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and     Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral     stents.   "
107376|NCT01880606|"     Evaluation of the efficacy of laser-based endomicroscopy as a complement to white-light     colonoscopy and chromoendoscopy for early detection of colon dysplasia in patients with     PSC-IBD. White-light colonoscopy is a routinely used procedure in colorectal cancer     surveillance programs. However, it does not permit detection of early dysplastic lesions.     Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscope helps to identify     flat lesions but is not suitable for accurate endoscopic diagnosis of dysplasia and     intraepithelial neoplasia Under this aim we will perform a clinical study evaluating a newly     developed technique allowing for in vivo confocal microscopy assessment of the colon mucosa     using laser-based endomicroscopy together with intravenous administration of fluorescein     (FITC).   "
107377|NCT01880593|"     The purpose of this study is to test the antidepressant effect of ketamine when given     repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention     strategy for patients with treatment-resistant depression (TRD) who respond to an initial     series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic     (a drug used to produce loss of consciousness before and during surgery). Ketamine is not     approved for the treatment of major depressive disorder and is considered experimental in     this study. An additional purpose of this study is to research the effects of ketamine on     brain function.      You may qualify to take part in this research study because you have been diagnosed with     major depressive disorder (MDD) and have not responded to past treatments.   "
107381|NCT01880541|"     The emergence of cognitive disorders after surgery under general anesthesia (GA) is the     second leading cause of patient complaints (after dental debris caused by intubation     techniques). These cognitive disorders can range from simple reversible confusion (26%) with     postoperative cognitive dysfunction without actual recovery (10%).      The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive     function remain to this day unknown, but appear promising.   "
107382|NCT01880528|"     This pilot clinical trial studies lisinopril in reducing shortness of breath caused by     radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects     caused by radiation therapy in patients with lung cancer.   "
107392|NCT01880398|"     Background: Fistula in ano is one of the most common diseases of the ano rectal region.     Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature.     Commonly prevalent surgical treatment for anal Fistula, that is Fistulectomy does not     provide successful cure for the disease, post operative complications and recurrences being     common. Acharya Sushruta an ancient Indian Surgeon has described in his text ' Sushruta     Samhita' about an ancient Ayurvedic technique of medicated thread called Ksharsutra treatment     for Bhagandara ( Fistula in ano). Treatment of anal Fistula (Bhagandara)and Nadi-Vrana(Sinus)     with Ksharsutra was practiced by Sushruta (1000-600B.C.) .      Hypothesis: Aycharya Sushruta advocated Kshar Sutra therapy in Fistula in ano and in various     types of Fistula.   "
107393|NCT01880385|"     Multi-center, non randomised, open label, non controlled pilot study. Evaluating the     treatment of bevacizumab in association with pre-operative chemotherapy, followed by surgery,     adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.   "
107383|NCT01880515|"     1. Advanced NSCLC has a poor prognosis and the positive impact of chemotherapy is limited          by the development of intrinsic and acquired resistance.        2. Over the past decade, less toxic agents such as the innovative targeted therapies, i.e.          erlotinib or gefitinib, have the potential to improve the effectiveness and keep a good          quality of life with a low toxicity        3. BIBW2992 (afatinib), an aniline-quinazoline, is an epidermal growth factor receptor          (EGFR) and human epidermal growth factor receptor 2 (HER-2) irreversible inhibitor, and          it has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2.        4. This molecule has shown benefits as a single agent in pre-treated patients who have          progressed despite platinum-based chemotherapy, with a minimal toxicity compared to          chemotherapy.        5. BIBW2992 is associated with adverse effects similar to those for erlotinib and          gefitinib, such as rash and diarrhea. These symptoms can reduce the quality of life (QL)          in patients and lead to inconsistent EGFR inhibitor dose administration        6. There is not a standard treatment for rash. However, case reports have tried to          demonstrate the benefit in the treatment of these cutaneous injuries obtained with          alcohol-free emollients, sunscreen with titanium dioxide or antibiotic (topic or oral)          treatment regimens that include clindamycin or doxycycline, as well as anti-inflammatory          drugs such as steroids and isotretinoin.        7. In order to reduce the incidence and severity of cutaneous toxicities, we will compare          the prophylactic antibiotic treatment using tetracycline and general dermatological          recommendations versus using only dermatological recommendations, in patients initiating          the treatment with BIBW2992.   "
107384|NCT01880502|"     A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I)     to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.   "
107385|NCT01880489|"     The objective is to expand and refine an intervention for transgender women (TW) into a     7-session individual- and group-based intervention that is scalable for community settings to     reduce sexual risk and substance use and to increase stigma-coping and risk-buffering     behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and     subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention     to a wait list control condition.   "
107386|NCT01880476|"     This study will examine the feasibility and acceptability of a 6-month interprofessional     community-based health promotion program, and explore its effects on older adults'     self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph     (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to     participate. Participants must be English speaking, community-dwelling, independent in     activities of daily living, and mentally competent to give informed consent. The 6-month     intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian     from DCG; participation in a monthly Diabetes Wellness Day group program offered through the     Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained     volunteers at the Diabetes Wellness Day group program; care coordination by the DCG     Registered Nurse to help participants access necessary supports and services; and monthly     team conferences between care providers at DCG and the GWSA to develop a client-centred plan     of care. To evaluate the program, participants will complete interviewer-administered     questionnaires before and after the intervention, and care providers and peer volunteers will     take part in group interviews.   "
107387|NCT01880463|"     The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in     25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study is being conducted among participants in VITAL and will     examine whether omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence     and/or progression of dry eye disease.   "
107388|NCT01880450|"     Project Prepared is a theoretically based, comprehensive, intensive group intervention that     is designed to prepare early adolescents for middle adolescence and its challenges. It     emphasizes skills in avoiding risky sexual situations, and provides medically accurate     information about sexual development, sexually transmitted infections and pregnancy.     Effectiveness is measured by using a randomized control trial design and tracking differences     in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual     self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs,     relationship self-efficacy), gender norms (macho man, powerless female), and resilience.   "
107389|NCT01880437|"     This study will assess the safety and efficacy of vismodegib in patients with     relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk     myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150     mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in     combination with cytarabine 20 mg subcutaneously for 10 days.      Anticipated time on study treatment is until disease progression, intolerable toxicity, or     patient withdrawal of consent.   "
107390|NCT01880424|"     This clinical trial is an international, multicenter, randomized, double-blind,     placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo.     Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be     randomized at up to 60 trial centers in China, Australia, and New Zealand.      The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12     weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment     Period, patients meeting the entry criteria for this trial will be randomized to one of two     double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).   "
107391|NCT01880411|"     Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose     Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL.      PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with     low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial     lesions (HSIL) of the cervix and induces a measurable immune response.   "
107394|NCT01880372|"     The purpose of this study is to evaluate the role of alpha lipoic acid in patients who have     moderate non-proliferative diabetic retinopathy.      The primary aim of this study is to test the hypothesis that the addition of alpha lipoic     acid in a diabetic patient's therapeutic regimen can decrease the progression of diabetic     retinopathy and preserve visual acuity.   "
107395|NCT01880359|"     The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from     this class are used against infection. In addition, nimorazole makes tumor cells more     sensitive to radiotherapy.      Therefore, the investigators want to find out whether the addition of nimorazole to the     standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows     activity against your type of head and neck cancer and is safe.      Furthermore the investigators will investigate if a specific examination done with your tumor     tissue will help to predict whether the treatment will work or not.      To find out if the activity observed with this treatment is not caused by chance alone, the     investigators need to obtain data from patients who receive this treatment and from patients     who receive other treatments.      The data from these two groups of patients will be compared to see which treatment is better.      Participants will be split into 2 groups. Each group will receive different treatments. The     treatment each group receives is determined by chance using a computer program. This works     like flipping a coin and is called randomization. This helps to make sure that groups of     patients are similar when the study starts. Neither you, your study doctor, nor the study     staff can influence in which group you will be placed or which treatment you will receive.      If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy     with cisplatin and nimorazole as a pill. This is considered the 'experimental' treatment.      If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy     with cisplatin and a so called 'placebo' as a pill. The placebo is a dummy treatment. It     looks like the real one, but it is not. It contains no active ingredient/medicine.   "
107396|NCT01880346|"     The investigators predict that a powder pill form of vitamin D will be more effectively     absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.   "
107397|NCT01880333|"     The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy     that was designed to be a less restrictive alternative to the traditional ketogenic diet.     This diet is started on an outpatient basis without a fast, allows unlimited protein and fat,     and does not restrict calories or fluids. Modified Atkins diet is of special importance in     resource constraint settings with paucity of trained dieticians. However, there is paucity     published data on the use of the modified Atkins diet in refractory epilepsy in young     children. This study aims to evaluate the efficacy and tolerability of the modified Atkins     diet in refractory epilepsy in young children.   "
107398|NCT01880320|"     The study hypothesis are based on the assumption that :        -  CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical          Gel Vehicle in the overall population and in the subgroup of severe Subjects        -  CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable          safety and tolerability profile   "
107399|NCT01880307|"     The purpose of this study is to determine whether a top-down treatment approach, prescribing     infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual     step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe     pediatric Crohn's disease (CD) patients.   "
107400|NCT01880294|"     The purpose of the study is to evaluate the differences or similarities in the results     obtained with two different scoring systems for chronic constipation in Asian participants     consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility     Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and     the ROME III diagnosis criteria (western gold standard).   "
107415|NCT01880099|"     You are invited to participate in a research study at the VA Connecticut Healthcare System     (West Haven campus) that examines whether a medication called galantamine can improve your     learning and memory, and also help you to quit smoking. You have been invited to participate     because you currently smoke cigarettes, and want to quit smoking. If you are eligible and     agree to be in the study, your participation will last for approximately 8 weeks. To     determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking     self-administration in a human laboratory model and b) improving abstinence rates at the end     of 4 weeks of treatment.   "
107440|NCT01879774|"     The aim of this epidemiological study is to characterize the neuropsychological and motoric     performance in patients with hyponatremia. Newer studies revealed an association between mild     hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the     paradigm of an asymptomatic hyponatremia. Until now, there is no known detailed     investigation and characterisation of the cognitive and motoric performance or limitation by     this disorder. Therefore this study will investigate patients with hyponatremia on the basis     of neuropsychological and neurological tests.   "
107401|NCT01880281|"     -  The G coupled-protein receptors 99 (GPR99) was discovered in 2002 by Wittenberg et al.          and is involved as a metabolic receptor. It has been shown that the natural ligand of          GPR99 is an intermediate in the Krebs cycle, alpha-ketoglutarate (aKG). Studies done on          rats have shown that aKG is measurable in the blood, freely filtered by the glomerulus          and highly reabsorbed in the proximal tubule in metabolic acidosis, while it is not          reabsorbed in metabolic alkalosis. No absorption or secretion of aKG intervene between          the end of the proximal tubule and the final urine. Thus, having a receptor aKG in the          distal tubule creates a paracrine communication with the proximal tubule, informing          about the acid-base status of the body and allows adjustment of the urinary excretion of          acid or base.        -  The hypothesis is that GPR99 is aKG sensor in the distal tubules and allow to report the          acid-base status (determined by the metabolic activity of the proximal tubule) of the          body to the distal tubule. This can then adapt the urinary excretion of acid or base in          the final urine. Acidifying the body by a high meat consumption associated with a test          of acidification, the kidney should reduce its aKG excretion and the concentration of          this metabolite should be even lower in the urine. And vice versa in the case of          alkalizing the body through a vegetarian diet associated with an alkalizing test.        -  Twelve healthy omnivorous volunteers will be selected. First inclusion visit includes          verification of inclusion/exclusion criteria and signed informed consent. Urine and          plasma baseline measurements will be performed and volunteers will meet a dietician.          This person will tell them concerning meat and vegetarian diet as well as how to have a          diet with 6g of salt per day.Volunteers are then randomized in order to determine which          diet they will start first.The first phase will last during 4 days. The diet is followed          during 3 days, and a 24-hour urine collection will begin on the third day at 7: 00 am.          The fourth day, volunteers will have an investigational's day at the investigation's          center after completing their urine collection at home (7:00 am). During the day of          investigation, volunteers will give their urine (8: 00 am, corresponding to the baseline          urine), and then the meat arm will receive a tablet of 50meq of NH4Cl and the          vegetarian arm will receive a tablet of 1g of NaHC03. Volunteers will stay in the          investigation center for 6h. Each hour since 8:00am, a urine sample will be taken, and          at 3 hours and 6 hours post-tablet, a blood sample will also be made.This          investigational's day will be followed by one to two weeks of treatment washing out.          After that, the second phase will begin and will as the first phase excepted that the          diet will be inversed.           5 other healthy vegetarian or vegan volunteers are recruited. Inclusion visit is the          same as omnivorous volunteers. Only investigational's day at the investigation's center          will be performed (no diet, no urine collection).   "
108221|NCT01869491|"     This study is being conducted to provide evidence that Compound Sodium Alginate Double Action     Chewable Tablets are effective in managing the symptoms of heartburn, acid regurgitation and     dyspepsia in patients with Gastroesophageal Reflux Disease (GERD).   "
107402|NCT01880268|"     This study integrates the wireless EEG system with an ordinary rehabilitation device (an     upper limb ergometer, arm bike) used in the Department of Physical Medicine and     Rehabilitation at our hospital for a brain-computer-interface (BCI)-controlled     neurorehabilitation device, and aims to test the effectiveness of this device. We hypothesize     that, the coupling of electroencephalographic signals related with initiation of limb     movements with a mechanical device which assists the intended movement is effective to     facilitate motor recovery in patients with brain lesion. We propose to enroll 20 patients     with cerebrovascular accident (CVA) (4-24 months after the onset of CVA) and the patients     will be randomly assigned to experimental (using BCI controlled device and undergoing     standard rehabilitation) and control groups (undergoing standard rehabilitation alone). To     compare the rehabilitation results among these groups, we propose to use various assessment     tools including clinical evaluation (Fugl-Meyer assessment, Modified Ashworth scale, Motor     Activity Log, Functional Independence Measure) as well as functional Magnetic Resonance     Imaging (fMRI) and Diffusion Tensor Imaging (DTI) before, immediate and 2 months after     completion of the training protocol.   "
107403|NCT01880255|"     In this study, the investigators will be examining the effects of repetitive transcranial     magnetic stimulation (rTMS) on memory deficits in individuals with schizophrenia and     schizoaffective disorder. Half of the study participants will be chosen by chance to receive     active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS     will feel the same as active rTMS only there will be no direct brain stimulation. This is     necessary to ensure that active rTMS is efficacious in the enhancement of memory in     individuals with schizophrenia. Based on results from a recently published pilot study, the     investigators propose that active rTMS treatment will result in a significant improvement in     working memory performance compared to sham rTMS treatment.   "
107404|NCT01880242|"     For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal     Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to     long-term complications range from rather immediate elastic recoil or vessel contraction to     longer processes like smooth muscle cell proliferation and excessive production of extra     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from     30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents     (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical     restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still     occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug     Eluting Stents (DES) significantly improved on the principle of BMS by adding an     antiproliferative drug (directly immobilized on the stent surface or released from a polymer     matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the     incidence of restenosis and resulted in a better safety profile as compared to BMS with     systemic drug administration. These advantages and a lower cost compared to surgical     interventions has made DES an attractive option to treat coronary artery disease. This     observational registry is designed to investigate and collect clinical evidence for the     clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers     patient population in daily clinical practice.   "
107405|NCT01880229|"     BioSensics has developed a Physical Activity Monitoring System (PAMSys) that consists of a     single wearable motion sensor that is worn on the torso. The objectives of this observational     study are the following: 1) to test the efficacy of PAMSys for objectively assessing a     persons risk of falling based on activity data measured during activities of daily living and     2) to test the efficacy of PAMSys for identifying precise early physical activity or     functioning indicators of frailty in those who are pre-frail or frail as compared to     non-frail controls.   "
107406|NCT01880216|"     Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when     a thrombus forms in one of the large veins, usually in the lower limbs, leading to either     partial or complete blocked circulation. The condition may progress to severe health     complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and     effective manner.      The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and     pulmonary embolism in the short term and to prevent recurrent events in the long-term.     Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also     increases the risk for major hemorrhage.      This trial aims to optimize the current medical knowledge on the effectiveness and safety of     two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein     thrombosis.   "
107407|NCT01880203|"     The purpose of the study is to investigate the contribution of molecular cytological analysis     (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with     indeterminate cytology (IC)   "
107408|NCT01880190|"     Various stimuli such as trauma, infection and major surgery may alter the physiologic immune     balance and initiate systemic inflammatory processes. This pathophysiological event is     characterized by the release of potent inflammatory mediators into the circulation.      Among these, pro- and anti-inflammatory cytokines such as interleukin-6 (IL-6), IL-8 or     IL-10, ICAM-1 play a dominant role as local or systemic regulators in the acute inflammatory     response. Recent studies have also investigated the role of matrix metalloproteinases (MMPs)     in the inflammatory response. The MMPs constitute a family of enzymes that are structurally     related neutral proteinases. MMPs can degrade essentially all extracellular matrix (ECM)     components and play an important role in wound healing and remodeling of the ECM. The     Tissutal Inhibitor MetalloProteine (TIMPs) are important regulator of MMPs activity.      The inflammatory response coming of surgery mainly affects surgical patients' outcome. Many     factors may attributed to this response, such as the kind of operation, the extent of     surgical trauma, the patient's medical history and therapy, as well as the type of anesthesia     used. Apart from that, the kind of fluids administered for volume replacement was revealed to     alter the inflammatory processes. Several studies have addressed on this issue mainly     involved abdominal surgery and provided compelling evidence that perioperative fluid     optimization produces benefits for the patient, with regard to inflammatory biomarkers such     as cytokines, matrix metalloproteinases, intercellular adhesion molecule-1(ICAM-1). They     support that the different volume replacement strategies, using only crystalloids or     combination of crystalloids with colloids (HES 130/0,4), may have important impact on immune     response. However, the relevant studies investigated different inflammatory biomarkers, and     usually involved either metalloproteinases, and their inhibitors (TIMPs) or cytokines.      In our study we investigated the hypothesis that intra- and postoperative volume replacement     with HES attenuates inflammatory response to elective abdominal surgery compared to RL fluid     therapy. For this purpose both metalloproteinases, MMP-9, MMP-13, their inhibitor, TIMP-1,     cytokines, IL-6, IL-8 and the intercellular adhesion molecule-1, ICAM-1 were investigated     postoperatively. Their changes during the first 24 postoperative hours consisted our primary     outcomes.   "
108568|NCT01864941|"     To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple     Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by     adverse events occurring within 48 weeks of the procedure.   "
107409|NCT01880177|"     The purpose of this qualitative work is to inform the content and structure of a new     screening measure for identifying undiagnosed at-risk COPD cases in primary care and support     content validity of the measure. This work will build on the results of a comprehensive     literature review and data mining analyses by identifying the symptomatic and health event     experiences of at-risk and newly diagnosed patients, as described by the patients themselves.     Specific objectives are as follows:      Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent     diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The     qualitative information obtained in these focus groups will be used to develop a new     questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings.      Objective 2: To review the new questionnaire with a new set of participants with a recent     COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b)     the content of each question is appropriate and understandable to participants, (c) the     intended connotation of each questions is consistent with participants' interpretation or     assigned meaning, and (d) to assure that content is not seen as redundant across items. This     will be done through one-on-one cognitive interviews.      Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without     or with a new diagnosis of COPD and the consistency of readings between electronic and     mechanical readings in these patients. This information will be used to inform the     development of peak-flow meter instructions for use as part of the screening methodology.   "
107410|NCT01880164|"     Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal     deformity.   "
107411|NCT01880151|"     Recent diagnostic criteria for Alzheimer's disease (AD) recognize an extended spectrum of AD     stages as part of the disease, including a preclinical stage. This underscores the importance     of early prognosis of AD when it is still possible to influence the course of the disorder.     The investigators propose a comprehensive project which will target the data-driven modeling     of the disease development. This goal will be achieved by creating and validating a battery     of new sensitive biomarkers for clinical evaluation and prediction of AD in individuals. The     AD-related brain changes will be assessed by noninvasive functional EEG measured during an     episodic memory task in subjects at different stages of AD, as well as in healthy controls.     The novel functional biomarkers will be extracted using a rigorous multistage selection     procedure involving advanced methods for feature extraction, as well as statistics and     classification for optimal selection. The ESTIMATE project will serve as a first step in an     extensive array of research procedures which will enable the early clinical identification of     Alzheimer's disease in elderly individuals who could then take advantage of preventive     pharmaceutical therapies.   "
107412|NCT01880138|"     Emergence agitation (EA) in children early after sevoflurane anaesthesia is a common     postoperative problem, with incidence ranging up to 80%. Younger patients, particularly in     the age range from 1.5 to 5 yr of age, are at increased risk of EA. Preoperative anxiety, as     measured by the modified Yale Preoperative Anxiety Scale, has been shown to increase the risk     of EA for each increment of 10 points in the child's state anxiety score. So, Alleviates     preoperative anxiety in Children maybe decrease the incidence and severity of EA. Preschool     children enjoy watching animated cartoons, and they can be immersed to animated cartoon so     they become oblivious of their surroundings. Therefore, viewing an animated cartoon maybe     reduce preoperative anxiety in children. This study was performed to determine effect of     animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after     general anesthesia   "
107413|NCT01880125|"     1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg          acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325          mg acetaminophen formulation after a single dose and at steady state        2. Subjects: Healthy subject        3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate          release treatment profiles at steady state.   "
107414|NCT01880112|"     Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will     be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is     intended to prevent infection from the surgery. It is unknown what the best dose for the     usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of     the tissue just under the skin will be biopsied at the time the incision is made and at the     time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken     as the womb is stitched closed after the delivery. Blood tests will be done at the start and     end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical     cord after the baby has been delivered and the umbilical cord has been cut. The umbilical     cord blood sample will be tested for the antibiotic level. These tests will be used to find     out if the usual dose of medicine is enough or if more medicine is needed to prevent     infection in normal weight women undergoing c-sections.   "
108049|NCT01871740|"     The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more     effective in preventing renal function decline among the patients with primary hypertension     when compared to enalapril maleate.   "
107422|NCT01880008|"     Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after     multimodal therapy, outcomes remain poor, with a median survival of one year. Although     advanced imaging methods have been suggested as molecular markers of prognosis and     therapeutic response, these methods have not been validated for clinical use. In this     exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of     glioblastoma will be followed prospectively for two years. The study examines how PET and MR     imaging signals change following administration of a standard radio-chemotherapy treatment     regimen to determine whether these imaging modalities can provide early indicators of     response to therapeutic intervention. The investigators hypothesize that decreases in uptake     of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy     will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the     investigators also will identify changes in diffusion and hypoxia MR imaging that may also     correlate well with treatment response.   "
108490|NCT01865968|"     A phase IV, randomization, single center, controlled clinical trial to compare the safety,     immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with     one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young     adults, and to evaluate the immunogenicity of a booster dose.   "
107416|NCT01880086|"     The purpose of this randomized controlled clinical trial is to evaluate the effects of     clomiphene citrate compared to placebo (substance without active medication) in men who are     taking pain medication (opioids) for chronic pain conditions and who have low blood     testosterone levels.      The condition of men having low testosterone with long-term pain medication (opioid) usage is     called opioid-induced androgen deficiency (OPIAD). Low testosterone can be caused by pain     medication effects on part of the brain (hypothalamic-pituitary axis) which ultimately result     in decreased testosterone production by the testes. Typical symptoms of low testosterone     (hypogonadism) may include decreased muscle mass, increased fat, osteoporosis, anemia,     erectile dysfunction, delayed ejaculation. In addition, men with low testosterone may     experience decreased attention, and decreased libido, fatigue, and depressed mood. Few     studies have looked at hormonal changes caused by long-term opioid usage in men.      Clomiphene citrate, a selective estrogen receptor modulator (SERM) oral medication which     inhibits estrogen effects (feedback) on the brain, has been identified by prior studies to     raise testosterone in men with low testosterone (due to reasons other than chronic pain     medication). Clomiphene citrate is also known to lead to increased sperm production in men     with low testosterone unlike testosterone topical or injection medications. Although     clomiphene citrate has been studied in hypogonadal men with beneficial outcomes and minimal     side effects, no group has previously studied clomiphene citrate as treatment in patients     with OPIAD.   "
107417|NCT01880073|"     A thorough infertility evaluation commonly involves determining whether a woman's fallopian     tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are     hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and     fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is     visualized passing through the fallopian tubes).      The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes     a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by     ultrasound. FemVue can be efficiently performed in a physician's office and is minimally     invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry     the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast.     It does, like the other two methods, carry a small risk of infection.      This study will involve using the FemVue device on patients under anesthesia in the operating     room before they undergo scheduled laparoscopic chromopertubation, the gold standard for     evaluating tubal patency. The two methods will be compared to determine the accuracy of the     FemVue device.   "
107418|NCT01880060|"     Given the prevalence of overweight and obesity, worksite-based health promotion programs have     been recommended due to their potential reach and social support impact. Within worksite     contexts, many strategies to prevent and treat obesity have focused on educational programs     delivered in person or to small groups that target knowledge acquisition and strategies     targeted at individuals to improve their dietary and activity practices. These programs have     been criticized because they typically reach a small percentage of workers—and seldom those     that could benefit most, are of short duration, and have typically small effects that are not     sustained. They have also typically been conducted in large worksites that have the greatest     resources. The lack of success of these programs may be due to: 1) inadequate intervention     intensity, 2) implementation challenges, and 3) a lack of theoretical models as the bases for     intervention development. To overcome the limitations of previous research we will conduct a     2 group randomized controlled trial to determine the reach and effectiveness of an extensive     intervention that: (a) is based upon sound theory, (b) is delivered primarily through     scalable interactive technologies, and (c) leverages the existing organizational and     environmental context of the workplace.   "
107419|NCT01880047|"     Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP     there are some patients who have been reported as non responders at the maximal approved dose     of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and     increasing response rate with increased doses of eltrombopag up to a dose of 75mg. Previously     published data has shown no overt increase in toxicity in normal volunteers, oncology     patients and aplastic anemia patients treated with escalated doses as high or higher than     those proposed in this study.      It therefore seems possible that in ITP patients who did not respond to a dose of 75mg daily,     eltrombopag could be more effective at a higher dose. We propose a double blind randomized     controlled trial in ITP patients who have been defined as non-responders at the maximum dose     (75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses (100mg, 125 mg,     150 mg)   "
107420|NCT01880034|"     Significant data exists to suggest that lipid emulsion administration in the setting of local     anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of     potential barriers exist to routine lipid emulsion administration for those performing     regional anesthesia including drug availability, drug cost and drug location. Inadequate     training or lack of established protocols also have the potential to negatively impact     patient outcomes. A previous study by Toledo et al (Availability of lipid emulsion in United     States obstetric units. Anesth Analg 2013;116:406-408.) evaluated lipid emulsion availability     on obstetric units and found that it was nearly universally available.      The Accreditation Council for Graduate Medical Education (ACGME) publishes a list of contact     information for each anesthesia institution that engages in resident training. Investigators     will contact these institutions by phone or email to obtain contact information for their     regional anesthesia program director. In the absence of a program director, investigators     will send a survey and consent information via email to the faculty physician most involved     in regional anesthesia. Survey completion instructions (survey itself to be completed on     Qualtrics Survey Hosting Service) and copy of the study consent form will be attached to the     initial contact email. The study consent form will contain a description of the study itself.     Survey participants will be allowed time to complete their survey in private at their     discretion. Non-responders will receive two follow-up emails at one month intervals.   "
107421|NCT01880021|"     The purpose of this study is to determine whether synthetic hernia mesh materials undergo     physical and/or chemical changes while in the body.   "
108050|NCT01871727|"     The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity     ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in     dose-finding part will be used to determine the dose of E7777 that should be used to test     efficacy and safety.   "
107423|NCT01879995|"     The mainstay of PKU treatment is a low-phenylalanine diet (i.e restriction of natural     protein), and supplementation with a protein substitute (a mixture of amino acids free from     phenylalanine, also containing micronutrients and vitamins) and special low-protein foods, to     meet the patient's energy requirements. When diet and treatment is relaxed after childhood,     adult and adolescent patients with phenylketonuria are at risk for malnutrition, depending on     the compliance with treatment and the intake of amino acid supplements.      In this study, nutrition status of patients with PKU and hyperphenylalaninemia is     systematically assessed under ongoing current treatment, in relation to Phe-tolerance,     compliance with treatment, and psychosocial issues.      Study participants do not undergo any specific therapeutic or diagnostic intervention.   "
107424|NCT01879982|"     For the moment, the detection of a mood episode in Bipolar Disorder (BD) relies on the     appearance of the first clinical signs that the clinician detect or that the patient becomes     aware of and reports to the clinician. Since physiological parameters such as cardiac     rhythms, respiratory rate, voice characteristics and actigraphy seem to be related to the     onset of a mood episode, information collected through the combined monitoring of multiple     selected physiological parameters (such as cardiac rhythms, respiratory rate, movements,     voice) during wake and sleep time, using wearable user friendly systems included into     garments as well as with a smartphone, may offer a new perspective in the long-term treatment     of BD.   "
107425|NCT01879969|"     The specific aims of the study were to measure and compare the rates of alignment and cant     reduction of the dental and facial midlines among the two groups.   "
107426|NCT01879956|"     Primary Objective:      Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving     executive functions in patients with refractory schizophrenia as measured by the BADS.      Secondary Objectives: improvement of functional aspects,basic and instrumental activities of     daily living,negative symptoms and cognitive functions improvement      Hypothesis: OT is more effective than control group to improve executive functions in     patients with refractory schizophrenia.   "
107427|NCT01879943|"     The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard     colonoscopy in patients with prior colorectal surgery.      The hypothesis is to validate the VCC as a means of screening for colonic polyps after     resection, which would avoid a colonoscopy with its associated general anesthesia and     potential side effects.   "
107428|NCT01879930|"     Chronic bladder pain syndrome is a chronic disabling disorder characterized by chronic pelvic     pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at     least one other urinary symptom such as persistent urgency or frequency in the absence of an     identifiable cause. Chronic bladder pain syndrome severely decreases an individual's quality     of life and represents a significant financial burden to those affected by it. Currently,     multifactorial pathogenesis is assumed including endocrine-involvement, pelvic floor muscle     irregularities, immunologic aspects and chemical causes. Corresponding to the wide spectrum     of presumptive triggers, a large number of therapeutic approaches are propagated, however     most are associated with limited effectiveness. Thus, treatment of BPS is a challenge and the     ideal therapy remains to be elucidated. Microorganisms such as Chlamydia trachomatis,     Ureaplasma urealyticum and Mycoplasma genitalium remains a challenge so that these organisms     may well be involved in the pathogenesis of chronic bladder pain syndrome. The investigators     hypothesise that doxycycline orally for 4 weeks, including therapy of the sexual partner, can     significantly relieve symptoms in women with chronic bladder pain syndrome   "
107429|NCT01879917|"     The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once     daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly     diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.   "
107430|NCT01879904|"     Superficial rectal tumors could be removed by ESD with two major advantages showed by the     literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was     lower than ERM therapy. This technique is actually performed routinely in Japan and     experience is limited in Europe, with few data in the literature.      This study is suggested to patients with superficial medium or distal rectal tumors. The     lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and     chromoendoscopy. Then, marking around the lesions was performed. Local injection was made     using injection needle, and then mucosal incision was performed around the lesion using     endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel     coagulation were practiced using primary hemostatic forceps during the procedure.      Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement,     undifferentiated, free margin less than 1 mm), a surgical resection is performed.      All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with     biopsies):        -  For complete resection, an endoscopic control was performed at 1 year.        -  For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic          control was performed at 1 year.      At one year, patient with incomplete resection have a surgical resection.   "
107441|NCT01879761|"     The purpose of this study is to determine how monocyte HLA-DR and other markers of immune     function change with time in patients with and without prior immune dysfunction who survive     sepsis from Staphylococcus aureus bacteremia.      We hypothesize that patients with prior immune dysfunction will have greater reductions in     HLA-DR and other markers of immune function after an episode of sepsis than people who do not     have prior immune dysfunction.   "
107431|NCT01879891|"     The primary goal is to test the hypothesis high interval exercise increases energy     expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise     cumulatively over 23 hours during and following the exercise. Secondary goals are to evaluate     exercise difficulty during moderate intensity exercise and high interval exercise as well as     difficulty of activities of daily living and free living physical activity following rest,     moderate intensity exercise and high interval exercise.      A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes in     muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be     increased following the high intensity interval exercise. In addition, these changes will be     related to changes in insulin sensitivity and increases in protein metabolism and muscle     damage.   "
130118|NCT01581879|"     The objective of this study is to compare the rate and extent of absorption of ziprasidone 20     mg capsules versus Geodon 20 mg capsules under fed conditions.   "
107433|NCT01879865|"     Dexmedetomidine is an α2-adrenoceptor agonist that has only recently been registered for     human use in Europe. It has sedative, analgesic and anxiolytic properties, but patients     remain arousable. This makes it an ideal drug for procedures which require the patient to     perform tasks, or for light sedation during procedures or in the Intensive Care Unit.     Pharmacokinetic models of (anaesthetic) drugs can be used in target controlled infusions     (TCI), to deliver stable plasma concentrations of drug during anaesthesia or sedation. There     are several models available for dexmedetomidine at this time, but the most often used models     (Dyck and Talke) underpredict the plasma concentration at higher concentrations. Also, plasma     concentrations aren't what the clinician is interested in, but in the effect. Therefore,     pharmacokinetic/pharmacodynamic (PKPD) models can be developed to titrate the drug to effect     instead of plasma concentration, using TCI. This has been done for many anaesthetic drugs,     but not for dexmedetomidine. Additionally, we want to investigate the effect of stimulation     on the pharmacodynamic effect of dexmedetomidine. The reason for this is that patients under     dexmedetomidine sedation are arousable by noises or touch. An operating room or ICU is never     quiet, and there are always sounds of monitors, alarms, and talking between team members or     activity around another patient in the same room, therefore the stimulation of the patient in     such an environment may have a profound effect on the sedative effect of dexmedetomidine.   "
107434|NCT01879852|"     This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a     traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of     standard or quadriceps intensive rehabilitation. The objective of the study was to determine     the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.   "
107435|NCT01879839|"     The aim of this study is to assess the effect of a diet prior to administration of contrast     agent in terms of a preventive procedure which leads to an attenuation of the     contrast-induced nephropathy (CIN).      Patients with a known kidney disease are especially at risk. A potential beneficial effect of     a diet prior to intervention has been shown in investigations in mammals, therefore this     study will investigate if a pre-interventional diet in patients with known kidney disease and     scheduled contrast agent examination can attenuate or prevent a post-interventional loss of     kidney function.   "
107436|NCT01879826|"     The purpose of this study is to test if treatment with laser therapy in pediatric patients     undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this     study, the participant will receive a laser acupuncture treatment targeting either kidney     acupoints or targeting sham points not associated with the kidney; the participant will not     get both. Both treatment sessions are given by a certified medical acupuncturist. The patient     will still receive standard pain control protocols with anesthetic medications like lidocaine     plus ketamine or fentanyl and versed during the biopsy, along with pain management after the     procedure. All medication will be administered without regard for which group the participant     has been randomized, as the treatment team will also be blinded.      Hypothesis:      We will test the hypothesis that treatment with laser acupuncture in patients undergoing     renal biopsies will improve patient satisfaction of the overall procedure.      Specific Aims:      Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall     satisfaction of renal biopsy.      Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of     sedative medication given during renal biopsy.   "
107437|NCT01879813|"     The study will explore the effects of a 6-week phospholipid drink intervention on the     cognitive performance and physiological and subjective stress parameters of males following a     repeated psychosocial/physical stressor.   "
107438|NCT01879800|"     The goal of this study is to 1) examine the feasibility and acceptability of a one-day     Acceptance and Commitment Training + Illness Management (ACT-IM) intervention in patients     with comorbid vascular disease risk factors and depression or anxiety; and 2) to evaluate the     effectiveness of this brief group intervention(ACT-IM), compared to Treatment-As-Usual (TAU)     on the mental health and functioning of patients with co-morbid mood/anxiety and vascular     disease risk factors. Patients with vascular disease risk factors will be identified by     physicians in Family Practice or Internal Medicine, through chart review, or through     advertisements. Those with vascular risk factors will be screened and assessed for symptoms     of depression or anxiety. Patients who are experiencing significant depressive or anxiety     symptoms and are interested in the treatment arm of the study will be randomized to the     ACT-IM intervention or to TAU. Assessments of the following will take place both before and     after the intervention: depression, anxiety, functioning, illness self-management, blood     vessel health, and blood.   "
107439|NCT01879787|"     This study aims to evaluate systematically and controlled the effectiveness of mental     practice techniques and modified constraint- induced movement therapy (mCIMT)in the treatment     of post-stroke patients with motor deficit in the upper limb. As well as finding a protocol     of transcranial direct current stimulation(tDCS)that will maximize the effects of the     practice of mental image and mCIMT. To this end, the subjects included will be submitted to     12 therapy sessions with active or sham tDCS combined with at least one of the following     techniques: conventional physiotherapy, mental practice technique or mCIMT   "
107442|NCT01879748|"     This study is designed to evaluate the pharmacokinetics of rasagiline in healthy Japanese and     Caucasian subjects after single and multiple doses of rasagiline.   "
107456|NCT01879566|"     The aim of this prospective single-center study is to evaluate sympathetic nervous system     directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular     compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome     (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness score>8[10],     and an apnea/hypopnea index (AHI>15/h) before and after catheter-based radiofrequency     ablation of renal nerve. If the selected patients are treated with CPAP, this therapy should     be stable during the whole study time. Primary and secondary end-point will be measured     before and 1, 3, 6 and 12 months after renal sympathetic denervation.   "
108395|NCT01867216|"     The main purpose of this study is to determine the safety of LY2922470, taken as oral     capsules, once or twice daily for approximately 28 days, in participants with diabetes. It     also aims to determine how long the drug stays in the body and how it affects blood sugar     levels. A screening appointment is required within 28 days before the start of the study and     a follow up appointment is required approximately 14 days after the last study dose is taken.   "
107445|NCT01879709|"     Cognitive impairment is a key disabling feature of SZ. The impairment affects functional     outcome and employability, resulting in increased burden. Currently, medications offer only     modest benefits for the cognitive dysfunction. Hence, non-pharmacological interventions are     worth consideration. Yoga is known to enhance cognitive abilities in healthy persons. Our     preliminary studies have shown for the first time that there may be remarkable improvement in     selected cognitive domains among outpatients with SZ. The improvement is unlikely to be due     to rater bias, as they were noted using a computerized neurocognitive battery. Since our     preliminary studies involved an open trial, it is necessary to conduct more controlled     studies. To evaluate our results further, we propose to test the effectiveness of yoga     supplementation using a controlled single blind design in India. Outpatients with SZ (N=258)     undergoing treatment at a large academic center in New Delhi, India will be randomly assigned     to one of the three groups- yoga training (YT, N=86), physical exercise (PE, N=86) or     treatment as usual (TAU, N=86). The YT group will undergo 21 days yoga supplementation, while     the PE group will complete a 21 day systematic physical exercise training regime. The third     group will have no such supplementation. Cognitive state, symptom severity and overall     function will be assessed at four time points: just before, immediately after, three months     later and six months after completion of YT/PE supplementation. The evaluations will be     conducted by raters blind to group status.      Hypotheses:        1. Yoga enhances attention, as well as related cognitive function among persons with          schizophrenia.        2. Yoga has beneficial effects on the short term functional outcome of schizophrenia   "
107446|NCT01879696|"     The proposed study is a double-blinded, randomized clinical trial of tissue pressure     monitoring only (Control group) vs. tissue pressure monitoring plus tissue ultrafiltration     (Treatment group) in patients with tibia fractures presenting to the trauma or emergency     departments at participating clinical sites. Tissue ultrafiltration refers to the removal of     muscle interstitial fluid by the ECSPRESS PMFC. The primary objective of the study is to     demonstrate whether the removal of interstitial fluid by the ECSPRESS PMFC/FC catheters     decrease the incidence of fasciotomy in the Treatment group when compared to the Control     group. Fasciotomy was chosen as the primary outcome because it is clearly defined and     clinically relevant; reduction of fasciotomy is of clear clinical benefit. Enrolled patients     may have isolated tibia fractures OR be multiple trauma patients (those with another major     fracture in a different body region or two distinct body system injuries, excluding those     with injuries to the opposite leg that would preclude them from completing required tests).   "
107447|NCT01879683|"     The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when     administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any     change in the bladder or in IC symptoms, following LiRIS administration.   "
107448|NCT01879670|"     Heart failure is a common condition, and the number of people with advanced disease continues     to increase. We need new treatments that improve patients' symptoms and extend life. Recently     the new CircuLite Synergy pump has come into use. It is the smallest pump manufactured to     date and does not cover the full work of the heart, instead providing partial support. One     interesting thing about this is that taking some strain off the heart might allow the muscle     to repair and rebuild its own strength. This process is called reverse remodelling, and is     the topic of this research. Our hypothesis is that partial support improves patients'     symptoms and causes improvement in heart muscle function. We also want to examine the best     techniques for assessing this, including new scanning and molecular tests, and study some     practical aspects of the pump to do with blood clotting.   "
107449|NCT01879657|"     To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and     OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers     and other imaging modalities like CT scan/MRI as gold standard.   "
107450|NCT01879644|"     Neurofeedback has proved to be effective in treating Attention deficit hyperactivity disorder     (ADHD) in experimental settings. This study investigates whether neurofeedback can be used as     a therapeutic intervention in regular outpatient care. The investigators compare high     frequent neurofeedback with high frequent self-management therapy and suppose that both     result in comparable effects.   "
107451|NCT01879631|"     Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical     shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It     can also halt the progression of disease owing to fibrotic activation in perpendicular     corneal incisions.   "
107452|NCT01879618|"     The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of     patients during dialysis.   "
107453|NCT01879605|"     This study investigated the effect of preoperative bowel preparations for patients undergoing     spinal fusion surgery.   "
107454|NCT01879592|"     Asthma and sickle cell disease each are serious medical problems. People with asthma have     difficulty breathing, wheeze (a whistling noise when breathing), cough, produce sputum or     phlegm, and have inflammation (swelling, irritation, redness) and narrowing of the bronchial     tubes.      When a person has both asthma and sickle cell disease together, more serious medical problems     can occur such as having acute chest syndrome and pain episodes more often. It is sometimes     hard to diagnose asthma in a person with sickle cell disease because sickle cell disease can     also cause lung problems.      The purpose of this study is to see if the investigators can better understand asthma when it     occurs in a person who has sickle cell disease. The investigators will do this by taking a     blood, urine, and saliva sample. The blood and urine samples will be analyzed for chemicals     and DNA (genes). Certain genes can cause patients to have sickle cell disease or asthma. The     investigators will use the saliva sample for future studies to compare the results from the     blood testing with saliva. The investigator's long-term goal is to make sure people who have     asthma and sickle cell disease are getting the best asthma treatments. The investigator's     hypothesis is that the analysis of the blood, urine and saliva using a method called,     metabolomics, may identify a unique asthma signature in children with sickle cell disease     which may lead to targeted treatments.   "
107455|NCT01879579|"     The purpose of this pilot study is to determine whether text message (and phone)     communication can be effectively utilized to adjust long-acting insulin, compared to standard     practice.   "
108051|NCT01871714|"     The current study design incorporates two previously developed, non-invasive approaches to     characterize the phenotype of individuals affected with XLHED.   "
107457|NCT01879553|"     The present study is designed to confirm the safety and immunogenicity of trivalent, surface     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.      For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will     be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at     approximately 21 days post vaccination.      The vaccine composition will be based on the WHO-recommended influenza strains for the     2013/2014 Northern Hemisphere vaccine, and the results of this study are intended to support     the use of this vaccine in future influenza seasons if the recommended vaccine composition     remains the same, in compliance with the requirements of the current European Union (EU)     recommendations for clinical trials related to yearly licensing of influenza vaccines.   "
107458|NCT01879540|"     The present study is designed to confirm the safety and immunogenicity of trivalent, surface     antigen, inactivated influenza vaccine including MF59C.1 adjuvant, formulation 2013/2014     Northern Hemisphere, in adults ≥65 years of age.      For the immunogenicity endpoints the antibody response to each influenza vaccine antigen,     will be measured by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition     (HI) at approximately 21 days post immunization.      The vaccine composition will be based on the World Health Organization (WHO) recommended     influenza strains for 2013/2014 Northern Hemisphere.      The results of this study are intended to support the use of this vaccine in future influenza     seasons if the recommended vaccine composition remains the same, in compliance with the     requirements of the current European Union (EU) recommendations for clinical trials related     to yearly licensing of influenza vaccines.   "
107459|NCT01879527|"     Following acute inflammation of the optic nerve region, as commonly seen in multiple     sclerosis patients, the optic nerve often undergoes atrophy, thus representing permanent     damage. Data from animal studies suggest that amiloride may prevent this process. The aim of     this study is to assess a potential neuroprotective effect of amiloride in acute autoimmune     inflammation of the optic nerve region.   "
107460|NCT01879514|"     IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary     nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most     main primary renal disease,could cause the uremia. It will be significant that early     indicators of prognosis and early intervention can be normalized and the scientific criteria     for judging the efficacy of great clinical can be established. The subject based on the past     study,literature research and various treatment will take the method of multi-center,     double-blind, randomized, control to investigate the standard treatment of severe IgA     nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM)     will be improved by the standardization of TCM research based on the epidemiological     investigation and statistical analysis. The subject will determine the efficacy of more     sensitive biomarkers and establish more scientific criteria for judging the effect with the     application of urine proteomics and metabolomics technologies in order to operate in the     formation of the standardization program of the treatment of severe IgA nephropathy with the     Integrative medicine of TCM.   "
107461|NCT01879501|"     The need for low vision services (LVS) will increase exponentially over the coming years due     to the anticipated and exponential growth in the ageing population in Singapore and a rise in     chronic non-communicable eye diseases. Finding the best evidenced-based management for     chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient     responsibility is the key to managing LV effectively.1 This means achieving optimum self     management (SM).2 However, there are currently no LV SM programs in Singapore and none has     been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to     evaluate health interventions.      The aims of this study are to assess the effectiveness of the 'Living Successfully with Low     Vision (LSLV)' program in improving quality of life (QoL) in 160 elderly people with LV     attending the Singapore National Eye Centre (SNEC) LV clinic. Of these, 80 will be randomly     allocated to receive the LSLV 4-week SM program while the remaining 80 will receive the usual     care. Comparisons will be made to determine the efficacy of the LSLV program. QoL,     self-efficacy, emotional well being, and vision-specific distress will be assessed 2 weeks     after training, and at six months and 12 months post intervention.      This study will be the first evidenced-based RCT investigating the effectiveness of a novel     vision-specific self-management strategy to improve QoL. It will also adopt a longitudinal     design where the effectiveness of these interventions will be evaluated at 12 months-the     first follow-up assessment of that duration at both national and international levels.     Furthermore this will be the first study to characterize and profile the patients where the     effect of the program did not demonstrate an improvement in both primary and secondary     outcomes six months after its completion. The future clinical implications of this study     include the potential to implement a successful model of LV rehabilitation in other tertiary     centres around the country.   "
107462|NCT01879488|"     Controlling the respiratory pattern of mechanically ventilated patients in volume control     mode is recommended during nebulization. No studies looked into conditions of nebulization     during assisted mechanical ventilation to define the optimal nebulization technique and its     effect on pulmonary deposition.      The aim of this study is to analyse the effect of ventilation mode (barometric versus     volumetric) on deposition by planar scintigraphy during mechanical ventilation.   "
107463|NCT01879475|"     The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to     Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac     and aortic thoracic surgery.   "
107464|NCT01879462|"     GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment     of chronic HCV infection. This study represents the first administration of GSK2878175 in     humans to define safety, tolerability, and pharmacokinetics (PK) following single and repeat     doses of GSK2878175 in healthy subjects.      This is a Phase 1, randomized, single-blind, placebo-controlled, dose escalation study to     determine the safety, tolerability, and PK profile of GSK2878175 in single (Part 1) and     repeat doses (Part 2) in healthy subjects. In addition the study will explore the effect of a     moderate (30%) fat meal on single dose PK endpoints in healthy subjects.   "
108052|NCT01871701|"     To evaluate the corrected QT interval change(automatic-reading) after single oral     administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean     Adults.   "
107465|NCT01879449|"     The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity     at a single long-term care facility for veterans and their spouses in Murfreesboro,     Tennessee. These data will be used to strengthen a future grant application to the Department     of Defense in response to their ongoing Traumatic Brain Injury initiative.   "
107615|NCT01877694|"     The purpose of this study is to evaluate the microbiological and clinical efficacy of     Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one     year of age and older with bacterial conjunctivitis in at least one eye may be eligible.     Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or     Vehicle Ophthalmic Solution.   "
107466|NCT01879436|"     Maternal malignancy during pregnancy is estimated to occur in 1 out of 1000 pregnancies.     Controversy exists regarding the effect of pregnancy on cancer prognosis. Gestational     hormones and pregnancy-related growth factors may induce a more aggressive behavior in     malignant cells. However, metastasis to the products of conception is rare. In the current     study investigators wish to analyze the effect of placental explants on cancer cells     (cervical, ovarian, thyroid, melanoma, lymphoma, leukemia and breast)phenotype (cell death,     proliferation, migration , invasion), signaling pathway, mRNA, miRNA and protein expression.   "
107467|NCT01879423|"     This is a single dose, open-label, randomized, two-period crossover study to demonstrate the     bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed     tablets (25mg) in healthy Chinese male subjects in fasting conditions. The safety,     tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will     also be assessed.   "
107468|NCT01879410|"     Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for     the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol     (FSC) is an approved drug that is already in use for the treatment of COPD. This is a     multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the     efficacy and safety of UMEC/VI 62.5/25 microgram [mcg] once daily administered via Novel Dry     Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg     twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12     weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25     mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted     approximately 7 days after the end of the study treatment.   "
107469|NCT01879397|"     Pilot prospective two group observational study to create a model of the carotid plaque     composition based on ultrasonic backscattered signals and select clinical data.   "
107470|NCT01879384|"     Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless,     a few authors reported follow up with microdialysis in bone flaps, and they all described the     position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue     is not always the reflect of bone vascularisation.      The aim is to study the feasibility of a follow up of microanastomosed bone flaps with     microdialysis. To reach this goal, investigators perform a clinical prospective research     project untitled MTM project   "
107471|NCT01879371|"     To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of     ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate     (Nurofen Immedia®).   "
107472|NCT01879358|"     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is     to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the     biolimus-eluting NOBORI stent in a population-based setting, using registry detection of     clinically driven events   "
107473|NCT01879345|"     Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of     BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male     volunteers   "
107474|NCT01879332|"     Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to     determine a maximum tolerated dose   "
107475|NCT01879319|"     The primary objective of this study was to assess users' ability to administer a full dose of     evolocumab in a home-use setting using either an automated mini-doser (AMD) or     autoinjector/pen (AI/pen).   "
107476|NCT01879293|"     Cardiovascular disease is the most common cause of death in the world. Most of the attention     in treating ischemic heart disease (IHD) is understandably directed toward treating coronary     artery disease. However there are other treatable culprits in these patients.      Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of     hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In     one study, the presence of LVH was a stronger predictor of mortality than either multivessel     cor-onary disease or impaired LV function.      Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes.     In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39%     lower risk of myocardial infarction compared with conventional therapy. Metformin also     offered dual benefits of improving vascular function and lessening ischemia in nondiabetic     patients.      Hence, the main aim of this study was to assess whether metformin could regress LVM in     patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and     endothelial function in this patient group.   "
107477|NCT01879280|"     The scientific objectives of this study are to systematically study the problems that are     created by incising the attachment of the temporalis muscle in a randomized group of     patients, and to determine whether another approach that does not detach the temporalis     muscle results in less post-operative morbidity. Cutting through the attachment of the     temporalis muscle to the skull is a widely-accepted procedure used to gain access to the     skull prior to the drilling used for a pterional craniotomy (one of the most frequent types     of surgeries used in neurosurgical practice). Despite the frequent use of this maneuver and     the known sequelae of temporalis mobilization (e.g. post-operative myofascial pain,     temporalis weakness, and pain with mastication), very little is known about the true     incidence of these post-operative symptoms. Furthermore, there is very little objective     evidence at the present time to support the claim that the incidence and severity of these     post-operative phenomena can be decreased with use of an osteoplastic craniotomy (a procedure     where the temporalis is left attached to the bony calvarium). The investigators would like to     evaluate whether this slightly more time-consuming and technically demanding approach is less     morbid in this respect than the contemporary pterional approach. Special note is made that     the osteoplastic approach has been used in standard neurosurgical practice for quite some     time.   "
108659|NCT01863758|"     To compare the number of breakthrough bleeds under tailored prophylaxis with human cell line     recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients     who received Human-cl rhFVIII as on demand treatment.   "
108155|NCT01870349|"     The purpose of this study is to determine whether there are differences in inflammatory     markers and bone-mediator protein expression in the fluid surrounding implant abutments     manufactured with either titanium or zirconium.   "
107478|NCT01879267|"     Huntington's disease (HD) is an incurable and fatal disorder characterised by progressive     degeneration of the basal ganglia and the cerebral cortex. Contrary to earlier thinking, HD     is associated with abnormalities in peripheral tissues which might even contribute to brain     pathology including muscle wasting, mitochondrial abnormalities, and impaired muscle energy     metabolism. Mitochondrial impairment and muscle atrophy in human HD patients and murine     models of HD are associated with altered expression of PGC-1a, a transcriptional cofactor     that seems to regulate many, if not all of the adaptations of muscle fibres to chronic     endurance training, and induces improved exercise performance and increased peak oxygen     uptake. We aim at investigating whether endurance exercise has the capability of stabilizing     and / or reversing PGC-1a dependent alterations of muscle function and structure in HD     patients, and whether muscle training ameliorates musculoskeletal and cardiovascular     function, as well as motor and cognitive symptoms in HD patients.   "
107479|NCT01879254|"     For this human research, 17 treatment-refractory OCD patients who already received DBS     implants for treatment refractory OCD between June 1998 and October 2007 will be included.     New patients that complete the protocol on refining the target for DBS in OCD will be     included in this follow-up study as well. They will be psychiatrically evaluated on regular     bases: at least twice yearly in the years two to five after surgery, at least once a year for     the years thereafter. The duration of this protocol is indefinite, but spans at least 10     years. The main aim of this study is to investigate the long-term effect of DBS in OCD     patients.   "
107480|NCT01879241|"     The primary objective of the trial is to investigate the survival time (the time from     randomization until death or end of the trial) compared between control group and     experimental group.      This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind     trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in     amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial     Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at     least 4 weeks prior to randomization.   "
107481|NCT01879228|"     In recent years, diabetes has emerged as one of the most significant co-diseases that many     Cystic Fibrosis (CF) patients develop. Type 1 and Type 2 diabetes results when either the     body does not make enough insulin or the body does not respond correctly to this insulin.     Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar)     from the food we eat to the cells of the body for energy. While cystic fibrosis related     diabetes (CFRD) has many features similar to both Type 1 and Type 2 diabetes, it is very     different; therefore, treatment and care of CFRD is not the same.      The purpose of this research study is to examine and understand the various mechanisms that     contribute to CFRD and gain a better understanding of potential means to treat CFRD. The     primary objective is to determine effectiveness of chronic incretin-based therapy vs. placebo     on insulin secretion in CF patients with indeterminate glucose tolerance, impaired glucose     tolerance, or CFRD.   "
107482|NCT01879215|"     This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on     patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs.     the suprapatellar approach. Subjects will be randomized to one or the other standard care     surgical approaches.   "
107483|NCT01879202|"     Fatigue is a common symptom in multiple sclerosis (MS) that is characterized by physical     and/or mental exhaustion. Fatigue is difficult to treat and treatment efficacy of available     therapy is limited. The goal of this study is to determine whether MS-associated fatigue     improves after 6 weeks of methylphenidate therapy. Treatment efficacy will be measured by a     questionnaire called Fatigue Severity Scale (FSS).   "
107484|NCT01879189|"     In order to better communicate personal risk of breast cancer to women who have not yet     initiated breast cancer screening (mammography), The Annenberg School of Communication at the     University of Pennsylvania has created a personal breast cancer screening decision aid tool.     This tool will be pilot tested, and then implemented and tested in nine primary care and     OB/GYN practices within the University of Pennsylvania Health System.   "
107485|NCT01879176|"     Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by     extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit,     endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation,     ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in     systemic inflammation and the main producers of pro- and antiinflammatory cytokines.     Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory     homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6     and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory     response induces post surgical monocyte immunosuppression which is indicated by an impaired     production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral     circulation with increased lactate levels, pronounced fluid accumulation, increased need of     vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning     from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to     decrease the inflammatory process have the potential to improve the perioperative course.      Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for     the first 36 hours after surgery and induces a decreased inflammatory response for up to 3     days post surgery.   "
107486|NCT01879163|"     This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313     vaccination compared to MVA85A vaccination, in BCG vaccinated adults.   "
107487|NCT01879150|"     Single center, open-label, single arm, pilot study designed to evaluate safety, tolerability     and efficacy of CYCLAPLEX device, a minimal invasive enhanced suture and button implant and     surgery tools for correction of inter-metatarsal angle in subjects suffering from mild to     moderate Hallux Valgus deformity   "
107488|NCT01879137|"     the purpose of the study is to investigate whether arginine infusion is a new tool to     differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.   "
107489|NCT01879124|"     The purpose of this study is to evaluate the prognostic performance of intrarenal resistive     index in the first years after kidney transplantation on graft function and on patient and     graft survival. In addition, the determinants of the intrarenal resistive index, including a     detailed analysis of the relation between graft histology and the intrarenal resistive index,     will be assessed.   "
107490|NCT01879111|"     Out-patients with coronary heart disease or hypertension will fill out a depression screening     questionnaire while waiting in a cardiac clinic. Using a randomised-controlled study design     half of the patients will receive a patient-targeted written screening feedback. This     feedback contains information about depression in general, depression-severity adapted     treatment guidelines and contact-information for treatment. Patients in the control group     receive no direct screening-feedback but their cardiologist will be informed about the     screening result. All patients with a positive screening-result will be contacted after one     month and six months and asked for symptoms of depression, and their use of health care. The     aim of this study is to evaluate the efficiency of this minimal intervention on the course of     depressive symptom in patients with known coronary heart disease or hypertension.   "
107491|NCT01879098|"     The purpose of this research study is to determine whether a probiotic can change the way     bile is used by the body. The investigators will also look at the effect of the probiotic on     your intestinal health.   "
107492|NCT01879085|"     This is a Phase Ib/II experimental, open-label, dose escalation, active treatment study     designed to determine the safety, tolerability, and recommended dose of the combination.      During the Phase 2 portion of the study, we will assess progression-free survival (PFS),     overall survival (OS),overall response rate (ORR), correlative endpoints, DNA methylation     measured by microarray, and expression level of the genes as measured by microarray   "
107493|NCT01879072|"     The goal of this protocol is to establish a cohort of at least 1500 biologic samples     collected prospectively from patients treated in BMT CTN centers that will be a shared bio     specimen resource for conducting future allogeneic hematopoietic stem cell transplantation     (HCT) correlative studies.   "
107494|NCT01879059|"     The effects of physical inactivity on variations in blood glucose and vascular health are not     fully understood. The purpose of this study is to determine if an acute transition from     physical activity to inactivity alters vascular health. Specifically, the investigators wish     to examine in healthy, lean physically active individuals (obtaining greater than 10,000     steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter     blood flow following a meal a marker of vascular health. Furthermore, the investigators wish     to examine if a one day return to physical activity (obtaining >10,000 steps/day) can restore     the detrimental effects on blood flow following a meal.   "
107495|NCT01879046|"     Articular cartilage can be the seat of many diseases including osteoarthritis and traumatic     defaults. The cartilage has no intrinsic ability to repair resulting at long term in function     loss in the joints. Currently available treatments are not satisfactory in the long term, the     use of mesenchymal stem cells appears to be promising due to their ability to multipotency     and immunomodulation properties. This project aims to determine the most appropriate source     for regenerative medicine of cartilage stem cells from tissue taken during arthroplasty in     patients with osteoarthritis. These cells will be tested for different chondrogenic markers.     The success of this project will consider the implementation of a strategy for regenerative     medicine in bone and joint diseases.   "
107496|NCT01879033|"     Childhood obesity is perhaps the most significant public health problem in the most developed     countries and is rapidly becoming so in developing countries. National Health and Nutrition     Examination Survey data shows a 3-fold increase in the prevalence of obesity in childhood,     over past few decades. Furthermore, childhood obesity has markedly contributed to the     prevalence of the metabolic syndrome and type 2 diabetes in U.S. children. Alarmingly, there     is increasing evidence that atherosclerosis develops silently during childhood in obese     children. In the Bogalusa Heart Study, pediatric autopsy studies showed a clear relationship     between the number and severity of risk factors, principally obesity, with atherosclerosis in     both the aorta and coronary arteries. Increased intimal medial thickness (IMT) was not     present among obese adults who had been normal weight as children, emphasizing the cumulative     effects of childhood obesity persisting into adulthood. Thus, the need for primary prevention     of cardiovascular disease beginning in childhood is strongly suggested.   "
107497|NCT01879020|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects   "
107498|NCT01879007|"     This study seeks to compare the pharmacokinetic characteristics of Factive 200mg Intravenous     Formulation (Gemifloxacin 200mg) with those of Factive 320mg Tablet Formulation (Gemifloxacin     320mg) and to explore possibility of clinical use of the IV formulation.   "
107499|NCT01878994|"     Objectives: To evaluate the effectiveness of the Nereu program compared to standard care     (advice on increased physical activity and nutrition) such as a health intervention tool for     the childhood obesity management      Methods/Design: The study design is a randomized controlled multicenter clinical trial using     two types of treatment. Population and sample: Children 6 to 12 years with overweight or     obesity, according to the z score of body mass index (BMI z) >= 1 for age and gender defined     by International Obesity Task Force (IOTF). It is considered necessary to recruit 100     children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8     month intervention with 3 weekly training sessions doing physical exercise for children and a     weekly session for parents of physical activity and healthy eating habits and behaviour     strategies, that involves both parental and child participation. The control group will     receive a monthly session of healthy physical and eating habits. Main Outcome Measures:     Improvement of BMI z, physical activity and nutrition habits, behaviour components and     quality life related to health at the end, 6 and 12 months after intervention.   "
107500|NCT01878981|"     To generate real world evidence to compare clinical outcomes and patient health-related     quality of life, resulting from catheter ablation therapy with clinical outcome and patient     health-related quality of life resulting from drug therapy in China. An economic model will     be constructed, and using the clinical events evidence collected in this study, and China     long-term disease progression and local disease cost data to perform a cost-effectiveness     evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF)     patients.   "
107501|NCT01878968|"     There is evidence to suggest that patients make different end-of-life decisions if they     understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study     will examine whether evidence-based informed consent impacts patients choices and healthcare     outcomes compared to routine care.   "
107502|NCT01878955|"     AMH is a member of the transforming growth factor family. It is produced by the granulosa     cells from 36th weeks of pregnancy.Ovarian granulosa cells are the only source of the     antimüllerian hormone. AMH production continues until response to exogenous FSH occurs and     follicles reach 4-6 mm in diameter.The number of follicles in patients with polycystic     ovaries are 2-6 times higher than normal women. Serum AMH levels are 2-3 times higher in     patients with PCOS. The cause of elevated serum AMH levels in patients with PCOS is unknown.     There are data showing elevated serum AMH level is due to the increase in the number of     follicles 2-8 mm in diameter. Although there is no precise definition; multicystic ovarian is     defined by the presence of more than six follicles 4-9 mm in diameter and mixed     morphologically with PCO. PCO and multicystic ovaries are distinguished by the absence of the     increase in stroma / volume.The aim of this study is to investigate whether there is a     difference of serum AMH levels between patients with PCO or multicystic ovaries. A primary     goal is to investigate the usability of AMH as a marker besides ultrasound for discrimination     of nonhyperandrogenic patients with PCO or multicystic ovaries.   "
107503|NCT01878942|"     The purpose of this study is to characterize the acute psychological, physiological,     endocrine, and pharmacokinetic, as well as long-term psychological effects of LSD in humans.   "
107504|NCT01878929|"     Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality     for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a     patient receives frequent, escalating doses of the allergens they are allergic to until they     reach a predetermined maintenance dose. This is followed by a maintenance phase during which     the allergen dose is kept constant and administered at greater intervals. Maximum clinical     improvement is generally not seen until a patient is in the maintenance phase. Anecdotal     evidence of possible reactions to SCIT administered during a patient's pollen season has led     to dosage freezes during a patient's pollen season which extends the length of the build-up     phase by many months. Prolonging the buildup phase increases the time required to obtain     maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy     due to the prolonged period of time when frequent injections are required.      The aims of this study are to determine if adverse reactions to pollen SCIT are increased if     doses are increased during pollen season.   "
107505|NCT01878916|"     Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in     myeloproliferative neoplasms (MPNs) than the normal population. In this study, we     investigated the thrombosis incidence, the effects of plasma homocysteine levels on     thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine     levels in MPNs, and to compare these results with the healthy controls.   "
107506|NCT01878903|"     When assessing acute post-operative pain, the validity, reproducibility and reliability of     Visual Analogue Scale (VAS) and verbal Numerical Rating Scale (NRS) have been investigated     extensively. The use of electronic version of VAS has been published in the recent 10 years     yet publication related to its use in pain medicine were few. Jamison et al have shown good     correlation between electronic VAS vs paper VAS on healthy volunteers using weight as the     stimulus. In normal subjects as well as fibromyalgia patients, electronic form of VAS could     be used to describe different levels of experimental heat stimulation.      Long term study had been done where electronic pain diary were compared against paper diary     in recording pain in 36 patients with chronic low back pain. The 2 scales showed good     correlation. This author use a software that is Palm-top computer based. Following these few     studies, validation study in chronic pain patient were published. A Palm-top computer based     VAS was compared with paper NRS in 200 chronic pain patients. The pain level recorded by the     two methods were considered equivalent by the author. However, Palm-top computer has almost     disappeared from the market nowadays.      Recent handheld electronic devices (iPad®) were incorporated with touch screen input     interface which allow users to use their finger as the input device. To our knowledge, there     is no published data concerning iPad-based VAS, especially in post-operative pain. We would     like to compare the data obtained from electronic VAS on iPad with verbal numerical rating     scale when acute post-operative pain is assessed.      Hypothesis The null hypothesis is that the two pain measurement method do not correlate. The     Spearman correlation coefficient between electronic VAS and verbal NRS will be reported.   "
107507|NCT01878890|"     Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal resistant     prostate cancer lead us to continue clinical development of efavirenz. Furthermore, all     available pre-clinical and clinical data lead us to conduct a Phase 1 study with efavirenz.     Objective of this Phase I is to test doses above 600 mg / day in patients with cancer in     order to determine the maximum tolerated dose to improve therapeutic effect.      This study is a single center Phase I trial, conduct with dose escalation scheme of efavirenz     by continual reassessment method likehood approach (CRML) on solid tumours (except pancreatic     cancer) and non-Hodgkin lymphoma (NHL).      Main objective is to determine the safety profile, and particularly the maximum tolerated     dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer)     or NHL in therapeutic failure.      Secondary objectives are:        -  Evaluate efavirenz pharmacokinetics at 2, 4 and 12 weeks;        -  Evaluate objective response at 12 weeks;        -  Evaluate progression free survival at 6 months;        -  Assess biological progression-free survival at 6 months (prostate tumours only).      Primary Endpoint      Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting     toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of     Efavirenz and will be defined as follows:        -  Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia,          nausea and vomiting, regardless of grade),        -  Any drug-related toxicity, regardless of grade, who led a treatment delay> 14 days,        -  Score ≥ 19 HAD during treatment. Secondary Criteria        -  Solid tumors: response and progression defined by RECIST v1.1 [Eisenhauer EA et al. EJC          2009).        -  Non-Hodgkin lymphomas: Response and progression defined according to Cheson criteria          [Cheson BD et al. JCO 1999]        -  Biological progression (particular case of prostate tumors): defined according to Scher          [Scher HI et al. JCO 2008] Statistical Considerations This is a Phase I dose escalation          strategy using the method CRML, described by O'Quigley and Shen [O'Quigley et al.          Biometrics 1996] and commonly used in Phase I trials in oncology.        -  Maximum number of eligible and evaluable subjects is 30.        -  Six dose levels are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000          mg.        -  The risk of dose limiting toxicities maximum allowed is 25%.   "
107551|NCT01878318|"     This open-label, single arm study will evaluate the effect of RoActemra/Actemra in     combination with methotrexate on articular damage in the hand (synovitis/osteitis and     erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate     response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will     receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.   "
107602|NCT01877863|"     The purpose of this study is to explore the impact of an intradialytic exercise program on     functional capacity, aerobic capacity, strength, quality of life, depression,     hospitalizations and intradialytic episodes of hypotension. The investigators would also like     to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as     the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned     outcomes will positively improve over the twelve week intervention.   "
107508|NCT01878877|"     Background Chronic pain is one of the major health problems among Western countries. It is     also one of the most frequent reasons for seeking medical care. Chronic pain is also an     important problem in Hong Kong. A study conducted in our institution in 2002 discovered that     the prevalence of chronic pain among Hong Kong adult population was 10.8%. This is expected     to be higher after a decade as the population is aging because old age is one of the risk     factors of chronic pain.      The changes in prevalence, pattern, severity and help seeking behavior should be explored in     order to evaluate the attitude toward chronic pain and the efficacy of chronic pain     treatment. A local study reported the prevalence of chronic pain in 2007 in Hong Kong was as     high as 34.9%. The reported rate was much higher than that of Ng et al. However, the     difference in methodology produced different results even though they were done in the same     population, which make the comparison difficult. Besides, the treatment efficacy and help     seeking behavior were not studied in this study. The differences in mode of data collection,     the wording of the questionnaire and the grouping of categories also influence the results of     the study. It is also desirable to have the update information of chronic pain in Hong Kong     regularly (i.e. every 5 years) in view of the rapid increase in prevalence of chronic pain in     Hong Kong.      To compare the changes in chronic pain prevalence and related outcomes, this study design is     similar to the previous study done in our institution in 2002. The definition of chronic pain     is the same as the previous study, which is pain persistence for 3 months or more. The mode     of conducting the interview and the questionnaire used will be grossly similar to the     previous study. Because chronic neuropathic pain is common and sometimes difficult to be     managed, questions about the incidence of chronic neuropathic pain will also be sought. This     important information has not been reported in Hong Kong before. The purpose of this study is     to obtain the update cross-sectional prevalence and demographic information of chronic pain     among Hong Kong adult population. The data will be compared with a similar study 4 done 10     years ago at our center in order to assess the change of chronic pain over the past decade.     Treatment seeking preference will also be assessed. We hypothesize that the prevalence of     chronic pain is increased when compare that of a decade ago.   "
107509|NCT01878864|"     A randomised cross-over study comparing two methods of local anaesthesia for patients     diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be     included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is     non-inferior to lidocaine-adrenalin injections.   "
107510|NCT01878851|"     Following medical history and clinical examination the children which are scheduled for     treatment with suspected pulpary involved primary teeth will be selected. During the regular     treatment if a pulp of primary teeth is opened and before the regular pulpotomy procedure is     performed the blood that is flowing out of the pulp will be collected and stored until     analyzed for the present of inflammatory markers. Clinical and radiographic evaluation will     be obtained in follow up appointments if the child will remain in regular treatments in our     clinic.   "
107511|NCT01878838|"     This study compares two FDA approved Cataract Lasers.   "
107512|NCT01878825|"     The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of     Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults     aged 18 years and older.   "
107513|NCT01878812|"     The purpose of this study is to assess, in adults 18 years of age and above, the     immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra     containing the four influenza strains (two A strains and two B strains) for the 2013/2014     season.   "
107514|NCT01878799|"     Background:      - Present treatment for hepatitis C includes the use of a weekly injection and two different     pills. This treatment is associated with serious side effects. Drugs that can be taken by     mouth and cure HCV infection without serious side effects would be a great help to the large     number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed     to treat the hepatitis C virus (HCV) infection. They are still being researched and are not     approved by the Food and Drug Administration. They are being developed as treatment for     hepatitis C as a single pill taken once a day.      Objectives:      - To determine whether a combination of the two study drugs can safely and effectively treat     HCV infection in people with HIV infection and who do not have cirrhosis of the liver.      Eligibility:      - Individuals who have HIV infection and have liver disease caused by infection with HCV.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. Urine samples will be collected from participants who might become          pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be          required.        -  Participants will take one pill daily for 12 weeks. This pill will be a combination of          the two study drugs.        -  Treatment will be monitored with frequent clinic visits and blood tests over a total of          60 weeks.   "
107515|NCT01878786|"     The purpose of this pilot study is to evaluate concentration-controlled everolimus with low     dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard     dose tacrolimus in de novo renal transplant recipients of ECD/DCD kidneys. Given tacrolimus     and MMF/MPA is a widely prescribed immunosuppressive regimen in the United States,     comparisons of tacrolimus and MMF/MPA regimens to investigational therapies and treatment     regimens are needed. Also, considering the fact that ECD/DCD is a fast growing fraction of     donors, evaluation of various regimens' effects on rather delicate ECD/DCD kidneys is     necessary.   "
107516|NCT01878773|"     This study will look at how feasible it is to use a certain type of Computed Tomography (CT)     to scan prostate cancer, called a high quality volume CT scan. It is hoped that this     technique will help doctors provide a higher-quality image of the prostate cancer, making it     easier to plan the area that will be treated. Using this type of CT scan will also lessen the     amount of time patients spend in the scanner.      This study will not offer patients a different treatment for their prostate cancer. Patients     will receive the most appropriate standard treatment whether or not they are in this study.   "
107517|NCT01878760|"     The aims of the APRICOT study are:        -  To establish the incidence of severe critical events in children undergoing anesthesia          in Europe.        -  To describe the differences in paediatric anaesthesia practice throughout Europe.        -  To study the potential impact of this variability on the occurrence of severe critical          events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis,          Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and          postanaesthetic Stridor).   "
107575|NCT01878214|"     The purpose of this study is to test an innovative and sustainable intervention to increase     participation in a union-sponsored smoking cessation program among carpenters and floor     layers. The investigators will conduct a randomized controlled trial comparing targeted     messaging versus standard messaging. All subjects will receive information about the free,     union-sponsored smoking cessation program. Subjects randomized to the intervention group will     receive additional targeted materials to encourage enrollment in the union's smoking     cessation program. The intervention will include monthly mailed and text messages. The     investigators hypothesize that subjects who receive targeted messages will be more likely to     enroll in the union-sponsored smoking cessation program, be more likely to show change in     readiness to quit smoking, and be more likely to quit smoking compared to subjects who     receive only standard messaging.   "
107518|NCT01878747|"     The goal of this randomized trial is to examine the effectiveness of a Provider Tailored     Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the     recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers     (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed     intervention, or a Control Group who will receive a 2-hour seminar on the management of     preoperative anxiety and postoperative pain and otherwise will provide standard care. The     aims of this study are to:      PRIMARY AIM      1. Determine if P-TIPS is more effective than standard care for preventing high preoperative     anxiety among children undergoing anesthesia and surgery. The primary outcome will be     observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale     Preoperative Anxiety Scale).      SECONDARY AIMS        1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain,          recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral          changes as measured by the PAED, and PHBQ        2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores          in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires        3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired          behaviors as compared to control group and whether these behaviors mediate the child and          parent-level outcomes.These behaviors will be measured using the m-PCAMPIS   "
107519|NCT01878734|"     Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the     government due to its major contribution to morbidity and mortality among children,     especially infants in their formative years. One of the most successful, cost-effective, and     recommended strategy to address micronutrient malnutrition is 'in-home fortification' with     micronutrient powders (Sprinkles being the most widely recognized) along with nutrition     education. While this intervention has proven to be safe, effective, and efficacious in     numerous other countries, a specific national protocol must be developed to maximize its     effect on reducing anaemia in Zambian children. The proposed research aims to inform such     protocol.   "
107521|NCT01878708|"     This is an open-label, single-arm pilot study of Oncaspar® with dexamethasone for patients     with relapsed or refractory peripheral T-cell lymphoma (PTCL), excluding extranodal NK/T cell     lymphoma (ENKTL). Patients will receive up to 8 courses of treatment.   "
107522|NCT01878695|"     NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a     common over-the-counter supplement and also is available as an injectable pharmaceutical that     protects the liver in cases of acetaminophen overdose. In the exercise physiology literature,     both oral and injectable NAC have been shown to reduce fatigue and improve recovery from     exertion which has interesting implications for exploring cancer-related fatigue.      In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in     the development and progression of breast cancer   "
107523|NCT01878682|"     VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source     of gentle vibration. It has been specifically designed to overcome the limitations of tuning     forks for testing the integrity of vibration sense in clinic and by the bedside. The product     is a hand held device that is used to examine the feet of Diabetic patients who are     susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive     and can be over a period of time, often not being completely resolved, and can lead to     amputation. The product will increase awareness of foot care and achieve a reduction in     incidence of foot ulcers.      The study aims to evaluate the accuracy of the VibraTip device compared to the Gold Standard,     the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of the     VibraTip® device, as measured by different community medical practitioners.   "
107524|NCT01878669|"     The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural     myocardial infarction and major cardiac and cerebral events in patients undergoing     percutaneous coronary intervention and who have moderate to high risk for contrast induced     nephropathy.   "
107525|NCT01878656|"     Emergence agitation is a major concern in patients undergoing orthognathic surgery. The     patients may experience the sense of suffocation during emergence due to nasotracheal     intubation and orofacial edema. Postoperative pain is also associated with emergence     agitation. Although there is a lot of studies about emergence agitation in children, there is     a few in adults, furthermore, no data about comparison of emergence agitation between     sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to     compare the incidence and severity of emergence agitation between sevoflurane and desflurane     anesthesia in adults after orthognathic surgery.   "
107526|NCT01878643|"     The purpose of this study was :        -  to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients        -  to determine the effect of inhaled antibiotics on respiratory infection   "
107527|NCT01878630|"     Superiority of additional Remote Patient Management (RPM) in patients with chronic heart     failure (CHF) in comparison to usual care in terms of, e.g.:        -  days lost due to unplanned cardiovascular hospitalization or death        -  all-cause mortality        -  cardiovascular mortality        -  quality of life   "
107576|NCT01878201|"     The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg     during 24 hours in Patients with Mild to Moderate Essential Hypertension   "
107577|NCT01878188|"     -  Safety and tolerability of three regimens of intravesically administered BC-819/PEI and          BCG (number of participants with AEs, discontinuations due to AEs)        -  Recurrence after treatment with BC-819/PEI and BCG        -  Approximately 18 patients with superficial transitional cell carcinoma TCC) of the          bladder        -  After initial evaluation and qualification, patients will be randomized to one of two          treatment groups, either alternating or sequential   "
107603|NCT01877850|"     The purpose of this study is to evaluate the difference of the duration of weaning process     from the ventilator between protocol-driven weaned patients and clinical judgment driven     weaned patients.   "
108523|NCT01865539|"     A randomized sham controlled trial evaluating the efficacy of the use of custom foot     orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes     that those veterans with chronic lower back pain who receive the custom foot orthotics will     show greater improvements in pain and disability associated with the chronic lower back pain     than those who receive the sham orthotic.   "
107528|NCT01878617|"     Historically, medulloblastoma treatment has been determined by the amount of leftover disease     present after surgery, also known as clinical risk (standard vs. high risk). Recent studies     have shown that medulloblastoma is made up of distinct molecular subgroups which respond     differently to treatment. This suggests that clinical risk alone is not adequate to identify     actual risk of recurrence. In order to address this, we will stratify medulloblastoma     treatment in this phase II clinical trial based on both clinical risk (low, standard,     intermediate, or high risk) and molecular subtype (WNT, SHH, or Non-WNT Non-SHH). This     stratified clinical and molecular treatment approach will be used to evaluate the following:        -  To find out if participants with low-risk WNT tumors can be treated with a lower dose of          radiation to the brain and spine, and a lower dose of the chemotherapy drug          cyclophosphamide while still achieving the same survival rate as past St. Jude studies          with fewer side effects.        -  To find out if adding targeted chemotherapy after standard chemotherapy will benefit          participants with SHH positive tumors.        -  To find out if adding new chemotherapy agents to the standard chemotherapy will improve          the outcome for intermediate and high risk Non-WNT Non-SHH tumors.        -  To define the cure rate for standard risk Non-WNT Non-SHH tumors treated with reduced          dose cyclophosphamide and compare this to participants from the past St. Jude study.      All participants on this study will have surgery to remove as much of the primary tumor as     safely possible, radiation therapy, and chemotherapy. The amount of radiation therapy and     type of chemotherapy received will be determined by the participant's treatment stratum.     Treatment stratum assignment will be based on the tumor's molecular subgroup assignment and     clinical risk.      The participant will be assigned to one of three medulloblastoma subgroups determined by     analysis of the tumor tissue for tumor biomarkers:        -  WNT (Strata W): positive for WNT biomarkers        -  SHH (Strata S): positive for SHH biomarkers        -  Non-WNT Non-SHH, Failed, or Indeterminate (Strata N): negative for WNT and SHH          biomarkers or results are indeterminable      Participants will then be assigned to a clinical risk group (low, standard, intermediate, or     high) based on assessment of:        -  How much tumor is left after surgery        -  If the cancer has spread to other sites outside the brain [i.e., to the spinal cord or          within the fluid surrounding the spinal cord, called cerebrospinal fluid (CSF)]        -  The appearance of the tumor cells under the microscope        -  Whether or not there are chromosomal abnormalities in the tumor, and if present, what          type (also called cytogenetics analysis)   "
107529|NCT01878604|"     Identify new or novel genes which may impact on cholesterol level, and establish the     relationship between those gene mutations with atherosclerosis, as well as responses to     lipid-lowering drugs.   "
107530|NCT01878591|"     To assess whether ultrasound methods can predict outcome of operative vaginal deliveries in     nulliparous women at term with singleton pregnancies and prolonged second stage of labor.      To compare different ultrasound assessments Compare digital assessments and ultrasound     findings. Investigate if movement of the fetal head during active pushing is a predictive     factor      Null hypotheses:        -  Ultrasound measurements cannot predict outcomes of operative vaginal delivery.        -  Ultrasound is not better than digital examination in predicting delivery outcome.        -  Movement of fetal head with active pushing is not a predictive factor.   "
107531|NCT01878578|"     The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA     2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the     tolerability and safety of ESL administered concomitantly with phenytoin in patients.   "
107532|NCT01878565|"     The host immunity has been generally recognized as the main factors to determine the outcome     of chronic hepatitis B virus (HBV) infection; however, previous studies have shown that     HBV-specific T cell and B cell function are exhausted in chronic hepatitis B (CHB) patients.     Recently, It is suggested that hepatitis B surface antigen (HBsAg) may play a key role in the     immune tolerance or immune exhaustion. Anti-HBV immune responses are partially recovered when     patients achieved hepatitis B e antigen (HBeAg) seroconversion during antiviral therapy, and     can be nearly recovered during HBsAg seroconversion. However, it is still difficult to     achieve the ideal terminal, HBsAg seroconversion. For this reason, immunotherapy would be     helpful to enhance the anti-HBV immunity and acquire higher HBsAg seroconversion. Here, the     investigators propose a hypothesis that hepatitis B immune globin     (HBIG)+granulocyte-macrophage colony-stimulating factor (GM-CSF)+HBV vaccine can enhance     anti-HBV immune responses and improve HBsAg seroconversion in CHB patients who has achieved     HBeAg seroconversion using nucleoside analogues treatment.   "
107533|NCT01878552|"     The investigator would assess if there is an incremental energy load during mechanical     ventilation in Acute Respiratory Distress Syndrome (ARDS) patients.   "
107534|NCT01878539|"     An intervention program targeting patients and caregivers based on education about their     condition and training in the use of portable coagulomenter to self monitor and training on     the treatment adjustment to self manage, can be effective to enable patients in OACs to self     manage as well as to identify determinant factors associated with the success and failure of     the program.   "
107535|NCT01878526|"     The investigators purposes are to define the prevalence of omeprazole resistance     gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy     of omeprazole in combination with algycon versus omeprazole in combination with domperidone     on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the     efficacy of omeprazole in combination with algycon versus omeprazole in combination with     domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.   "
107536|NCT01878513|"     The aim of the study is to examine whether determining treatment strategies based upon     Cytochrome P450 2D6 (CYP2D6) genotype will improve drug response rates and clinical outcome     in patients with psychosis.      The investigators predict that prospectively testing CYP2D6 genotype and using this     information to treat psychotic patients with risperidone will improve clinical outcomes.     Specifically, CYP2D6 poor metabolizers who are treated with low dose and slow titration of     risperidone will do better than those who are treated with usual dose and titration approach     in terms of rates of side effects and clinical improvement.   "
107537|NCT01878500|"     The aim of this study is to investigate the use of intraoperative stereotactic imaging of the     pelvic floor musculature during closure of bladder exstrophy.   "
107538|NCT01878487|"     To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with     ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration     catheter in 40 patients during primary PCI.   "
107539|NCT01878474|"     The purpose of this study is to assess the safety and tolerability of single doses of TA-8995     in healthy Caucasian and Japanese volunteers.   "
107540|NCT01878461|"     This study is to evaluate the efficacy and safety of M518101 in subjects with plaque     psoriasis   "
107541|NCT01878448|"     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,     Ltd.      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and     VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore ALTN     for the effectiveness of advanced soft tissue sarcoma and security.   "
107542|NCT01878435|"     The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile     phone short message system (SMS) reminders, either with or without mobile-phone based travel     subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in     rural western Kenya.   "
107543|NCT01878422|"     Study Design: This is a pragmatic study on the management strategy for patients with     metastatic colorectal cancer (CRC) who are candidates for CT, independently of any previous     adjuvant therapy received. The aim of this study is to define the role of new target     molecules in combination with CT in first- and second line treatment.      First line study: Eligible patients were randomized to either treatment:      Arm A: FOLFIRI or FOLFOX + Bevacizumab, cycle to be repeated every 2 weeks        -  BEVACIZUMAB: Day 1,1st cycle 5 mg/kg IV infusion of 90 min Day 1, 2nd cycle if well          tolerated, 5 mg/kg IV infusion of 60 min Day 1, 3rd cycle and subsequent cycles if well          tolerated, 5 mg/kg IV infusion of 30 min after 5-Fluorouracile (FU) bolus        -  FOLFIRI Day 1: Irinotecan 180 mg/m2 IV infusion 30-90 min      Day 1,2:      L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus     5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours - FOLFOX Day 1: Oxaliplatin 85     mg/m2 IV infusion of 2hours      Day 1,2:      L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus     5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours Arm B: FOLFIRI or FOLFOX, cycle     to be repeated every 2 weeks If FOLFIRI: FOLFIRI as specified in arm A without Bevacizumab If     FOLFOX: FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both arms,     CT was repeated until progressive disease (PD) or unacceptable toxicity occurs. If     unacceptable CT-related toxicity occurs in ARM A, in the absence of PD patients stopped CT     and continued with only bevacizumab 5 mg/kg as a 30-min infusion every 2 weeks until     progression or intolerable toxicity occurred.      Second line - it is divided in two different studies (2A and 2B):      Study 2A: Patients from arm A and Kras Wild Type were randomized to:        -  Arm C: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as defined in          arm B)        -  Arm D: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as described          in arm B) plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hrs          before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1          hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm          C.      Study 2B: Patients from arm B and Kras Wild Type were randomized to:        -  Arm E: FOLFIRI or FOLFOX (the CT schedule not received in the 1st line trial, as defined          in arm B) plus BEVACIZUMAB        -  Arm F: FOLFIRI or FOLFOX (the CT schedule not received in the first-line trial, as          defined in arm B) plus BEVACIZUMAB and CETUXIMAB; cycle to be repeated every 2 weeks,          whilst cetuximab will be administered weekly.        -  BEVACIZUMAB 2nd day of 1st cycle 5 mg/kg IV infusion of 90 min 2nd day of 2 nd cycle if          well tolerated, 5 mg/kg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent          cycles if well tolerated, 5 mg/kg IV infusion of 30 min after the end of 5-FU bolus on          the 2nd day        -  CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hr before CT infusion 1st          cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion          If cetuximab will be stopped for any of the reasons specified in this protocol,          bevacizumab will be administered as defined in arm A of the 1st line study Patients from          arm B and Kras Mutant were treated according to arm E. Objectives of study The primary          objective of the 1st line study is to determine whether the addition of bevacizumab to a          poly-chemotherapy (polyCT) regimen (FOLFIRI or FOLFOX) improves efficacy in terms of          progression-free survival (PFS). The secondary objectives of the 1st line study are to          determine the Overall Response Rate (ORR) and the safety profile of the treatments          administered.      The primary objective of the 2nd line studies is to determine, separately for each study,     whether the addition of cetuximab to a polyCT schemes (FOLFOX or FOLFIRI), or to polyCT     schemes plus bevacizumab, improves efficacy in terms of PFS.The secondary objectives of the     2nd line studies are to determine the ORR, the overall survival (OS) and the safety profile     of the treatments administered.   "
107544|NCT01878409|"     The aim of this study is to evaluate the different aspects of sexual function among adults     with Parkinson Disease to develop a treatment and address sexual problems as a routine part     of diagnostic workup and therapeutic planning.   "
107545|NCT01878396|"     The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in     Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated     BRAF.   "
107546|NCT01878383|"     PCR detection of HSV DNA shedding in the female genital tract using the GeneXpert system     (Cepheid, Sunnyvale CA) will be compared with traditional (routine) PCR (pregnant and     nonpregnant women) and with HSV culture (nonpregnant women). The GeneXpert system performs     all sample-processing steps and real-time PCR in a single integrated cartridge. The standard     cartridge is an inexpensive disposable plastic cartridge with filtration and ultrasonic lysis     capabilities. It consists chiefly of several combined molded plastic components: a cartridge     body containing eleven fluid reservoirs or chambers along with an attached PCR tube, a     specialized valve body with an ultrasonic interface containing a sub-micron filter and glass     lysis beads, and a rotary valve with an axial syringe barrel. The operation of the cartridge     is simple. The rotary valve contains an inlet and an outlet port. Fluid such as a sample     buffer can be drawn up into a syringe drive through the inlet port of the rotary valve and     then dispensed into any other chamber within the cartridge by rotating the valve and     expelling the fluid through the outlet port. The fluid can either be passed through a filter     contained within the valve assembly or it can be passed directly into the next chamber     without filtration, depending on the path that is chosen. The cartridge fluidics and     subsequent real-time PCR all are performed within the GeneXpert instrument. The GeneXpert     contains multiple modules (ICORE units) that can be independently programmed to drive the     syringe/rotary valve, and to perform four-color real-time PCR. Each cartridge fits inside one     module, and all processing, PCR, and analysis steps are performed automatically. Each ICORE     module can be run and analyzed independently, so batching of samples is unnecessary.   "
107547|NCT01878370|"     In a previous study, the investigators delivered graphs to family physicians that outlined     the proportion of patients with a history of diabetes or heart disease achieving     evidence-based quality targets derived from guideline recommendations. A qualitative     evaluation found that participating family physicians did not act upon the feedback for two     main reasons. First, they felt that targets recommended in guidelines often did not apply for     particular patients. Second, they complained that had difficulty using the feedback reports     that only provided aggregate level data for clinical action. In this cluster-randomized     trial, the investigators test two approaches to conducting audit and feedback that aims to     address these issues. The investigators hypothesize that feedback identifying a small number     of patients at high-risk for cardiovascular events requiring action will more effectively     lead to changes in clinical behavior than feedback identifying all patients not reaching     optimal care targets.   "
107548|NCT01878357|"     Mass Drug Administration (MDA) and Mass Screening and Selective Treatment (MST) might be     applied as strategies for eliminating malaria when focusing on transmission stages. Many     studies either with MDA or MST has been done in low transmission areas demonstrated the     impact of those activities to reduce malaria transmission. However, in high transmission such     study is still very limited which is becoming the reason behind this study.      A randomized cluster trial of MST study using dihydroartemisinin-piperaquine plus primaquine     (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara TImur     province, Central Indonesia. There will be three arms in the study, i.e. (1) intervention arm     of mass screening and treatment with interval of 6 weeks; (2) intervention arm of mass     screening and treatment with interval of 3 months and (3) control arm without mass screening     and treatment. The intervention arm with 6 weeks interval represents a new proposed method to     detection malaria infections, while the intervention arm with 3 month interval represents the     Ministry of Health current policy of active case detection in Indonesia, and the third arm     will serve as the control for Ministry of Health's policy.      The study will be conducted in 6 months period and evaluate various parameters including     malaria incidence and proportion of anemia in monthly cohort school children (in arm1, 2 and     3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All     positive subject in all arms will receive supervised treatment. Secondary objectives are the     proportion of gametocytemia in the community, the proportion of malaria antibody of various     age groups, population genetic of local parasite, submicroscopic incidence based polymerase     chain reaction and the proportion of infective mosquitoes. Data analysis will be performed     according to the method for cluster randomized trial evaluation.   "
107549|NCT01878344|"     The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and     cerebral events in patients undergoing primary percutaneous coronary intervention who have     moderate to high risk for contrast induced nephropathy.      In a sub-group of patients coronary flow reserve will be evaluated.   "
107550|NCT01878331|"     Patients with an edentulous mandible restored with implants who have participated in the core     study CR 04/07 will be recruited for this extension study. No further interventions will be     made for this extension study other than a clinical follow-up examination and questionnaires.     Patients will not receive an investigational treatment in this study. Patients will be     followed at 5 to 10 years from the date of the original implant loading   "
107552|NCT01878305|"     Neuromonitoring of critically ill patients in the intensive care unit (ICU) is challenging.     Clinical scoring systems produce insufficient information with deeply sedated patients, and     disturbances of normal hemostasis limit the use of invasive intra-cranial pressure     measurements. EEG based monitoring algorithms have been introduced into the operation theater     and general anaesthesia, but these algorithms cannot be used in the intensive care setting     without modifications. EEG is also susceptible to electrical disturbances, such as those     created by patient movement.      The study is conducted in Finland, in the intensive care unit of the Surgical Hospital of     Helsinki. The total number of patients in this study is 20, and it is a part of a larger     neuromonitoring study with a total of 110 patients. The patients are divided into four     subgroups, as follows: 1. patients admitted to ICU with acute liver failure, 2. patients     admitted to the postoperative cardio-thoracic ICU after cardiac surgery with perioperative     total heart arrest, 3. patients admitted to the ICU because of status epilepticus and finally     4. patients in critical condition, admitted to the ICU after any surgery. This study     concentrates on the first group of patients with acute liver failure.      Clinical care of patients is not altered. When arriving into the ICU EEG-monitoring will     added to routine monitoring. To evaluate the neurological status the following tests are     performed: clinical test, blood tests and transcranial doppler ultrasound. The Entropy of EEG     is measured along with the raw EEG signal.      The recruiting of study patients was begun in December 2005 and the final study patients were     recruited in December 2011. GE Healthcare Finland supplies the entropy monitoring devices and     pays the salary of the research nurses who collect the study data. Clinical investigators     will not receive funding from any commercial company. All patients (or their next of kin)     included have given their written informed consent for inclusion in the study.      The aim of this study is to find new factors and new non-invasive techniques, which correlate     with the neurological state and outcome of patients suffering critical illness.   "
107553|NCT01878292|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone     relative to placebo in adolescent outpatients (12-17) with major depressive disorder.   "
107554|NCT01878279|"     In the proposed study, the investigators will carry out novel research to evaluate both     symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy     number in children with and without HIV.      Study Objectives:        1. To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected          children           Secondary Objectives:        2. To determine the acceptability of performing daily oral swabs in children age 3-12   "
107555|NCT01878266|"     This Trial offers a reduction in patient burden, which is especially preferable in children     with a poor compliance and poor performance status. This prospective randomized trial was     extension to the previous controlled prospective study performed in Children's Cancer     Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this     work is to demonstrate noninferiority of the hypofractionated regimens relative to the     conventional regimen in a controlled randomized clinical study.   "
107556|NCT01876628|"     The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting     antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin,     results in less tissue damage and a more rapid resolution of both systemic and local     features, in a cost-effective manner. This study is a randomised controlled trial comparing     Clindamycin with placebo.   "
107557|NCT01876615|"     The objective of this study is to compare pharmacokinetics after single oral administration     of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in     healthy male volunteers   "
107558|NCT01876602|"     The specific aims of this study are to: 1) evaluate the impact of a novel intervention     delivered via school-based physical education (PE) on adolescents who have a high sensitivity     to exercise-induced negative affect; 2) determine whether adolescents' tendency to feel     uncomfortable during exercise is a stable trait that persists even in the face of an     intervention; and 3) compare and contrast three alternative methods of measuring adolescents'     sensitivity to exercise-induced affect.      Healthy middle-school students who do not participate in team or individual competitive     sports will be recruited and assessed to determine their existing predisposition toward     exercise (i.e., reluctant exercisers and latent exercisers). The assessment will be     conducted using three methods that have been used to measure individuals' propensity to     experience positive affect in the face of a stimulus: 1) a pencil-and-paper assessment that     measures tendency to respond to a challenge with positive affect; 2) electroencephalogram     (EEG) to ascertain frontal cortical asymmetry; and 3) empirically assessed affective response     to a standardized exercise task. Reluctant and latent exercisers will be assigned in equal     numbers to one of two conditions. One condition will implement a PE-based intervention that     differs from the traditional approach in that students will be instructed to exercise at an     intensity that has been determined to elicit positive affect in that individual (based on     baseline testing). In the other condition, students will be instructed to exercise at an     intensity derived from standard formulas typically used in exercise prescriptions. It is     hypothesized that the non-traditional approach will increase reluctant exercisers' enjoyment     of PE and also their level of participation in physical activity outside of PE. The latter     will be determined using portable monitors (accelerometers) worn at baseline, after the     intervention, and again 1 year after the end of the intervention.   "
107559|NCT01876589|"     The purpose of this study is to examine the improvement of myocardial blood flow induced by     regained vasomotor functions of the stented coronary segment after resorption of BVS over     time.   "
107560|NCT01876576|"     This study will evaluate the expansion of dietary options from clear liquids the entire day     to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with     MoviPrep® and its effect on preparation quality for colonoscopy.   "
107561|NCT01876563|"     The aim of this study is the comparision between the effects of vitamin D or placebo     supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase     activity in patients with type 2 diabetes   "
107562|NCT01876550|"     The primary objective of this study is to determine the comparability of the safety and     efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily     infected traumatic skin lesions. It will also be determined whether the efficacy of each of     the active treatments is superior to that of the vehicle cream (placebo).   "
107563|NCT01876537|"     THEME RELEVANCE. Sacrococcygeal pilonidal sinus disease (SPD) is a congenital disease that's     well spread and constitutes 1-2% of all surgical pathologies. In all Coloproctological     pathologies, the disease composes 14-20% (G.I. Vorobjov, 2006; V.D. Fedorov, 2005; Gupta P.J.     et al., 2005). Clinical manifestations of pilonidal sinus disease mainly due to the     appearance of inflammation in it.      The main approach in the complex treatment of this group of patients is to execute radical     surgery. The guiding principles in it are adequate sanation and drainage of purulent focus.      Despite the fact that this disease is the subject of numerous medical journals, monographs,     research works, masters and doctoral theses, frequency of unsatisfactory outcomes remains     high (recurrence - from 10% to 19%, wound inflammation - 20-30%). In this case terms of     stationary and out-patient treatment increase till 30-70 days (G.I. Vorobjov, 2006; B.M.     Dacenko et al., 2004; Cubukcu А., 2001, Perruchoud С, 2002).      The frequency of unsatisfactory results after excision of SPD directly depends on the kind of     surgery. After palliative surgery (incision and drainage of abscess) in 11.7 - 25.2% of     patients occurs recurrence of the disease (McCallum I., King P.M., Bruce J., 2007;), for the     open wound healing recurrence occur in 3-8% of the operated. For primary wound healing in     7,5-9,7% required re-surgery (V.K. An, 2003; A.A. Kartashev, 2011).      Sacrococcygeal pilonidal sinus disease overwhelmingly affects people, mostly young working     age, and treatment failure leads to long-term temporary disability of patients.      In the last few years continue to discuss methods of one-time or multi-stage radical surgical     treatment of pilonidal sinus, but to date there is no single approach to the choice of     surgical treatment for this disease (V.L. Denisenko, 2008).      Success of surgical treatment of SPD depends on the development and introduction of new     devices and techniques exist to produce convergence and immobilization of the wound edges,     thereby obtaining its primary healing and a significant reduction of wound surface.      The high frequency of the disease and postoperative complications, as well as long-term     temporary disability of patients demonstrates the relevance of the development of modern     methods of radical surgery of sacrococcygeal pilonidal sinus disease (V.I. Pomazkin, 2008).      AIM OF RESEARCH. The aim of our research is to improve the results of complex radical     surgical treatment of patients of sacrococcygeal pilonidal sinus disease through the     development and introduction of new devices and techniques for convergence and immobilization     wound edges.      TASKS OF RESEARCH.        1. To conduct a comparative analysis the most common surgical treatment of SPD in the          frequency of complications in the intra- and postoperative periods.        2. To develop a device for convergence and immobilization wound edges in patients with SPD.        3. To analyze the effectiveness of the developed techniques and devices in comparison with          traditional surgical treatment.        4. To make practical recommendations on the options and methods of using the developed          methods and devices.      NOVELTY OF RESEARCH. For the first time, based on the design and creation of an     approximation-immobilization device (RU Patent № 112020, Bull. № 1, 01.10.2012) will be     improved the surgical treatment of patients with this pathology, clinical and anatomical     study of the proposed device for different configurations of gluteal-sacrococcygeal region,     as well as the analysis and justification of the basic parameters of wound (length, depth and     width of the wound, the number of stitches, the complication rate , the area of the wound).      Developed a method of closure of the wound defect after radical excision of pilonidal sinus     by Krivonosov-Brezhnev (RU Patent № 2,464,943, Bull. № 30 from 10.27.12.), that significantly     reduces the risk of postoperative complications in patients with acute inflammation of the     SPD.      For the first time an analysis of postoperative period in patients operated with the proposed     methods compared with traditional methods of surgery was performed.      POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process     of coloproctological departments at all levels, as well as the learning process of medical     schools.      EXPECTED EFFECTIVENESS.        1. Scientific and technical effect: developed new techniques and devices for convergence          and immobilization wound edges used for the treatment patients with SPD.        2. Medical and social effects: the introduction into clinical practice of the developed          techniques and devices will improve the results of surgical treatment of patients with          SPD by rigid fixation of wound edges, by reducing the time of postoperative wound          healing, by decreasing the risk of complications in the early postoperative period.   "
107564|NCT01876524|"     The purpose of this study is to study the efficacy and security of noninvasive brain     stimulation as a new approach for patients with Substance Use Disorders (SUDs) plus other     psychiatric conditions like ADHD, Schizophrenia, Bipolar disorder, etc.   "
107565|NCT01876511|"     This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T     cells) is effective (anti-tumor activity) and safe in three different patient populations.     These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative     colon cancer, and 3. patients with other MSI positive cancers.   "
107566|NCT01876498|"     The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by     patient with Morbus Dupuytren and to build up a register.   "
107595|NCT01877954|"     The primary aim of this study was to compare the absolute and relative effectiveness of     asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS)     maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI)     compared with fluticasone propionate (FP) pMDI.   "
107596|NCT01877941|"     The specific aim of this study is to assess whether a device approved by the FDA to measure     pulse oximetry can accurately estimate cardiac output.   "
107567|NCT01876485|"     This hybrid effectiveness/implementation trial will be conducted in two phases over four     years. In Phase 1, the investigators will evaluate the process of implementing a     collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care     [EPIC]) personalized to self-reported patient activation and functional health literacy (FHL)     levels into routine primary care practices. In Phase 2, the investigators will conduct a     randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care (EUC).     In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284 Veterans     with poorly controlled diabetes defined by average hemoglobin A1c over the last six months of     >= 8% to receive EPIC or enhanced usual care (EUC). Consented subjects will be allocated     evenly between EPIC and EUC. EPIC consists of six 1-hour group sessions focusing on 1) Your     Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans, 4)     Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6)     Reviewing and Planning for the Future. After each group session, a one-on-one session between     a designated PACT member and patient participants will focus on collaborative goal-setting.     Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes     management, and will also receive a packet of educational materials regarding diabetes     management, including a letter delineating the diabetes management resources available at     their facility. Study measurements using self-reported questionnaires and blood tests to     assess blood sugar control will be obtained at baseline, post-intervention, and post-six     month maintenance period.   "
107568|NCT01876472|"     Adult recipients of cochlear implants (CI) generally loose interest in listening to music.     This may be due to the rather limited spectral resolution of CI. However, child     CI-recipients, if offered the opportunity, like to listen to music. They participate actively     in musical acitivities, such as singing, dancing or playing an instrument. Thus, there seems     to be a fundamental difference in the music perception of people who receive CI as child or     as adult.      This study assesses music perception skills of child, teen and adult cochlear implant     recipients in settings with simple tone sequences and in a more complex, melodious context.   "
107569|NCT01876459|"     Patients with memory disorders are experiencing different trends which are difficult to     predict. Moreover, the distinction between Lewy body disease and Alzheimer's disease is not     easy as both diseases can present similar symptoms. Nowadays, routine examinations exist and     can improve the diagnosis but there are not specific enough of one of those two pathologies.      Lewy body disease is characterized by the presence of particular structures in patient's     brain, called Lewy body, composed of a protein called alpha-synuclein. The aim of this     study is to measure the rate of alpha-synuclein in cerebrospinal fluid. This measurement     could allow us to differentiate patient with Alzheimer's disease from those with Lewy body     disease.   "
107570|NCT01876446|"     This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients     with small cell lung cancer that has returned after a period of improvement. Pegylated     irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth.   "
107571|NCT01876433|"     Objective: The objective of the study is to assess the structural and functional cardiac     effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart     failure.      Design: We are planning a study aiming at establishing proof of concept that treatment of     patients with HF with Mirabegron has significant positive effects, as assessed by clinical     and biochemistry measurements, but not by hard endpoints. We are performing a combined     dose-finding - chronic efficacy study.      The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is     6 months. 70 patients with chronic heartfailure will be included.      Specific aims        1. Determine safety of administration of Mirabegron to patients with heart failure.        2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac          structural remodelling in patients with heart failure.        3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by          questionnaires and 6 min walk test in patients with heart failure.        4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and          arrhythmias in patients with heart failure.        5. Determine effects of Mirabegron on circulating biomarkers in patients with heart          failure.   "
107572|NCT01876420|"     To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.   "
107573|NCT01878240|"     Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age     groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death.     Federal funding through Medicare has been allocated for early detection using abdominal     ultrasound screening programs. Despite these more aggressive screening programs and concerted     efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to     increase.      Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006.     Multiple studies reflecting decreased perioperative morbidity and mortality over open repair     make this an attractive option for patients. EVAR requires more intensive follow-up than     standard open surgical repair, however. Secondary interventions are more common to maintain     seal of the endograft within the aorta and subsequent exclusion of the aneurysmal     component.      The term endoleak is specific to EVAR, and describes the primary means by which endografts     fail. Type I endoleaks occur because of inadequate graft seal proximally or distally,     resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when     branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to     collateral flow. Type III endoleaks occur when flow persists between segments of a modular     graft. Type IV endoleaks occur when flow persists through endograft material (graft     porosity). Type V endoleaks have also been called endotension, and occur when     pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type     III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also     lead to aneurysm rupture and premature death.      The most common method of EVAR follow-up is computed tomographic angiography (CTA). These     studies allow accurate measurement of aneurysm sac diameters and volumes. They also are     highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain     persistent and are present in the setting of aneurysm sac enlargement. Type I and III     endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with     current endograft technology.   "
107574|NCT01878227|"     The purpose of this study is to compare the lipid lowering effects and clinical safety of a     natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in     Chinese patients with moderate dyslipidemia.   "
107597|NCT01877928|"     The purpose of this study is to assess the efficacy of the Boussignac positive airway     pressure system (a mask) applied immediately following post-operative extubation in improving     lung function in patients with obstructive sleep apnea (OSA). Assessments will be done before     surgery and then at 1, 2 and 24 hours following extubation and will be compared to standard     care for perioperative airway support. The study aims to give a broader and more inclusive     picture (than the current literature) in terms of whether the Boussignac CPAP system should     be considered for utilization by anesthesiologists caring for surgical patients with OSA.   "
107578|NCT01878175|"     Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often     used to treat hip osteoarthritis, which is more common among Veterans than the general     population. Some patients continue to experience functional limitations after THA, and     studies have shown that these patients still tend to put greater loads on the opposite leg,     which can increase the risk of developing osteoarthritis in that leg. One likely reason for     these post-surgical limitations is that rehabilitation is very minimal following this     procedure. This project will involve development and preliminary testing of a functional     movement retraining program, designed to help Veterans improve their function and     biomechanics after THA. The project will also develop processes for delivering this program     in Veterans' homes, to increase accessibility.   "
107579|NCT01878162|"     Law enforcement officials (LEOs) demonstrate an elevated risk for occupational injury. The     effectiveness of exercise-based work injury prevention programs (WIPPs) to reduce the risk     and costs associated with occupational injury has yet to be tested rigorously in LEOs. The     accuracy of existing field tests of physical functioning to predict occupational injuries and     related expenses remains unclear. The objectives of this study are to: (i) determine the     effect of an exercise-based WIPP on occupational wellness and productivity in a cohort of     LEOs, and (ii) to determine the accuracy of 2 common field assessments of physical function     to predict lost work productivity and related expenses in a cohort of LEOs.   "
107580|NCT01878149|"     The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel     results to XLIF® single or multilevel results relative to the safety endpoints. This study     will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3     months prior to the initiation of this study. Given that fusion generally takes at least 6     months to determine, the aim of this study is not to determine fusion but to consider the     short-term (out to 6 months) reported adverse events between the two cohorts.      Devices used in both systems are cleared for use and conform to US regulatory requirements.     The study employs these procedures and devices for uses that are consistent with their     510(k), legally cleared, labeling.   "
107581|NCT01878136|"     This study will evaluate the hypothesis that the administration of intraventricular tPA     reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent     hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.   "
107582|NCT01878123|"     This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time     in human study of AMP-110 in adult subjects with rheumatoid arthritis.   "
107583|NCT01878110|"     This pilot study is being conducted in order to help make the case for later, more systematic     research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating     trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment     techniques in the form of a clear written manual for therapists; determine whether therapists     can use these guidelines in a consistent manner in making treatment decisions; develop and     test the reliability of measures of how well therapists are conducting the treatment; and     collect preliminary data on the acceptability of the treatment to patients.   "
107584|NCT01878097|"     The purpose of this study is to evaluate the statewide application of Green Dot among high     schools students. We hypothesize that students in high schools with Green Dot will over time     report lower rates of sexual violence (SV) compared with students in comparable high schools     randomized not to have Green Dot. This reduction in sexual violence will be mediated through     a reduction in social norms supporting sexual violence (measured with violence acceptance     scales) and an increase in bystander behaviors.   "
107585|NCT01878084|"     The purpose of the present research is to evaluate the effect of bioactive glass in bone     regeneration immediately following extraction of mandibular and maxillary premolars.The     hypothesis of the study assumes that this treatment would promote the healing of the     extraction socket while preserving both the height and width of the bone. Furthermore, it     would allow more effective tooth movement during orthodontic treatment.   "
107586|NCT01878071|"     In recent years, greater emphasis has been placed on the link between oral and systemic     health. Obesity, a growing medical problem worldwide, has been associated with multiple     chronic inflammatory diseases such as diabetes mellitus and cardiovascular disease. With     respect to the effect of obesity on periodontal health, it has been shown that obese subjects     exhibit higher inflammation around natural teeth and are at increased risk of tooth loss than     individuals with normal weight. Peri-implantitis, an inflammatory condition of bacterial     origin that occurs around oral implants and resembles periodontal disease, has become a     serious concern for the dental profession given its increasing prevalence and challenging     treatment. There is also strong evidence that individuals with a history of periodontitis are     also at risk for peri-implantitis. However, knowledge about the pathogenesis and treatment of     peri-implantitis is scarce. Hence, it is extremely important to understand the implications     of excessive body fat on peri-implant health. Based on the current understanding on the     effect of obesity on systemic and local inflammation around natural teeth, the investigators     hypothesize that obesity will have a significant impact on peri-implant health by inducing an     increased inflammatory response as measured by clinical as well as molecular markers of     inflammation.   "
107587|NCT01878058|"     This study will look at the feasibility of using a type of Magnetic Resonance Imaging called     Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers     hope that using SWI will eliminate the need to use CT imaging to detect your implanted     radioactive seeds.      This study will also see if the MRI seed detection is as effective as current standard     practice of seed detection (routine MRI and CT imaging). This technique would be beneficial     for brachytherapy without the need to fuse the MRI and CT images, as is done currently.   "
107598|NCT01877915|"     The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared     with placebo (inactive medication), in reducing the risk of death, myocardial infarction or     stroke in participants with heart failure and significant coronary artery disease following     an episode of decompensated heart failure.   "
107599|NCT01877902|"     STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN     PUBLIC HEALTH SYSTEM   "
107600|NCT01877889|"     The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the     body) of canagliflozin with the pharmacodynamics of dapagliflozin.   "
107588|NCT01878045|"     Background:      - An ongoing study is looking at American Indians who have kidney problems caused by type 2     diabetes. Kidney disease due to type 2 diabetes is a major problem in American Indians. We     previously found that early treatment of kidney disease with losartan was probably beneficial     for reducing progression of the disease. Researchers now want to see if these benefits     continue to be seen several years after the end of the treatment study.      Objectives:      - To study long-term benefit of losartan treatment for diabetic kidney disease in American     Indians with type 2 diabetes.      Eligibility:      - Participants in the American Indian diabetic kidney disease study (OH95-DK-N037).      Design:        -  Participants will have a physical exam and medical history before starting the study.          Blood and urine samples will be collected.        -  Participants will have a set of tests as part of this study. Those who have severe          kidney problems, such as kidney failure, will only have a basic kidney exam with scans.          The remaining participants will have a full urine collection and analysis. They will          also provide a kidney biopsy.        -  Treatment will not be provided as part of this study.   "
107589|NCT01878032|"     Background:      - The purpose of this study is to find out whether color vision measured with the Cambridge     Color Test is a good way to examine the severity of inherited retinal diseases (IRDs). IRDs     are a major cause of vision loss worldwide, but very little is known about how the diseases     affect color vision over time. This study will tell us if color vision may be used to track     changes in inherited retinal diseases over time.      Objectives:      - To improve understanding of color vision as a way to measure changes in inherited retinal     diseases.      Eligibility:        -  People 5 years of age or older who have an IRD.        -  Healthy volunteers at least 5 years of age.      Design:        -  Participants will make at least one visit to the National Eye Institute clinic. If they          sign up for more tests, they may have up to three visits to the NEI clinic.        -  Participants will be asked questions about their medical and eye history.        -  Participants will be given an eye exam, including eye drops to dilate their pupils. They          will take the Cambridge Color Test, which includes looking at a monitor and pressing a          button, and arranging colored circles. Several other tests may be offered, but          participants can decline to take them.        -  Treatment will not be provided as part of this study.   "
107590|NCT01878019|"     Background:      - Researchers want to look at how the brain responds to painful stimulations. They also want     to see if these responses are different in people with and without chronic pain. To test the     brain s response, they will use a chemical called naloxone. Naloxone is used to treat     overdoses of painkilling drugs like morphine. It may be able to block the effect of a     pain-relieving cream. Researchers will apply a pain-relieving cream to a person s lower leg     and look at the results of sensitivity tests with either naloxone or a placebo. This study     will compare the results from people with chronic pain (like fibromyalgia) to those of people     without chronic pain.      Objectives:      - To look at the brain s response to pain in people with and without chronic pain.      Eligibility:        -  Individuals at least 18 years of age who have fibromyalgia.        -  Healthy volunteers at least 18 years of age.      Design:        -  This study will involve a screening visit and two testing visits. The testing visits          will be about a week apart.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. After the screening participants will be administered several          questionnaires about their personality, and their thoughts and feelings.        -  At the first visit, participants will try out the magnetic resonance imaging (MRI) scan          before using it at the next visit. They will then have the painkilling cream applied on          one part of their lower leg and a normal moisturizing cream on the other part of their          lower leg. They will have heat pulses on these skin areas and rate the pain.        -  At the second visit, participants will have tests in the MRI scanner. The heat pulse          tests will be repeated after an infusion of either naloxone or a placebo....   "
107591|NCT01878006|"     Background:      - Small differences in genes may alter responses to drugs. One gene that has different forms     is the mu opioid receptor gene. People with one form of this gene are more sensitive to     alcohol. People with a different form are sometimes more sensitive to pain. Morphine and     other prescription pain pills produce pain relief by acting at the mu opioid receptor.     Researchers want to see how well a drug called remifentanil can help determine sensitivity to     pain. Remifentanil is a strong but short-acting pain medication that is sometimes used for     anesthesia during surgery. The study will test how much the drug causes the pupils to     constrict.      Objectives:      - To see if remifentanil can help determine pain sensitivity.      Eligibility:      - Individuals between 21 and 55 years of age who are taking pain pills that were prescribed     to treat pain from a medical or dental procedure.      Design:        -  This study has a screening phase and a study phase. The screening phase involves one or          two visits of 5 to 6 hours. The study phase is one outpatient visit that will take about          3 hours.        -  Participants will be screened with a medical and psychiatric history and physical exam.          They will be asked about drinking and drug-taking history, and any family history of          alcoholism or drug abuse. Blood, urine, and breath samples will be collected.        -  During the study session, participants will test their sensitivity by placing one hand          in cold water. Pupil diameter will be measured before and after the sensitivity test.        -  After a blood sample is taken, participants will receive the remifentanil. The          sensitivity test will be repeated. Final blood samples will be collected. A brief          physical exam will also be performed.        -  Participants will stay in the clinic until the effects of the drug have worn off.        -  About 1 week after the study session, participants will have a follow-up phone call.   "
107592|NCT01877993|"     Autonomic nerve function is involved in both blood pressure (BP) regulation and the     pathogenesis of coronary artery spasm (CAS), but few studies have been published about the     relationship between CAS and BP, with the exception of studies that explore hypertension as a     risk factor for CAS. The purpose of this study was to investigate the incidence of CAS and     atrioventricular (AV) block in association with BP level. The investigators will register     consecutive patients who underwent coronary angiography with an acetylcholine (Ach)-induced     provocation test from November 2004 to May 2012. The investigators exclude from the patients     who were taking antihypertensive drugs or who had a documented history of cardiovascular     disease in order to avoid the confounding effects of cardiovascular medications on coronary     vasomotion. CAS is defined as >70% luminal narrowing on Ach provocation and /or concurrent     chest pain. The study population will be divided into quartiles of rising systolic BP and     diastolic BP. The incidence of Ach-induced CAS according to each systolic BP/diastolic BP     quartile will be evaluated.   "
107593|NCT01877980|"     The aim of the present study was to evaluate the ultrasonographic airway measurement in     pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with     the minimal transverse airway diameter (MTAD) with tube size predicted by different     age-related formulas and diameter of little finger.      Previous studies already showed that a prediction of pediatric ETT is possible with the     ultrasonographic measurement of the MTAD. In this study measurements are performed at three     predefined anatomic structures of the airway with each of These at two airway pressures.      The investigators hypothesize that one of the specific measurements predicts the fitting ETT     size better than age-related formulas or diameter of little finger.   "
107594|NCT01877967|"     This research aims to determine whether a 12 week daily dose of VSL#3 has any measurable     effects on memory, attention, executive function or self-reported mood and anxiety in healthy     older adults.   "
107601|NCT01877876|"     Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version     is RevK.   "
107604|NCT01877837|"     This protocol will be investigating the use of stem cell transplantation, in related donors,     to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point     mutation that results in the substitution of valine for glutamic acid at the sixth position     in the B-chain of hemoglobin. This leads to sickling of the red blood cells under many     conditions, such as hypoxia, dehydration, and hyperthermia. The sickling leads to     vaso-occlusion, which causes irreversible damage in almost all systems in the body, including     the central nervous system (CNS), lungs, heart, bones, eyes, liver, and kidneys.   "
107605|NCT01877824|"     All Danish trainees in surgery in a two-year period asked for participation when enrolled in     the formal five-year training program for specialty in surgery. The participants are     randomized for either educational intervention or control (without intervention). The     intervention group receive a skills-lab course in hernia repair followed by an opportunity to     perform 20 groin hernia repairs in their departments within 4-8 weeks. Their performance will     be video recorded three times during the intervention and as follow-up at end of the first     year of training. After termination of the hernia training program a similar program for     laparoscopic cholecystectomies are made. Each participant receive both intervention. The     control group are video recorded at start of their first year and at end. All videos are     blindly assessed with a validated rating scale of operative performance. The purpose is to     assess if a fast-track program improves technical skills and if a change is sustained.     Furthermore we want to compare outcome in similar training programs in open and laparoscopic     skills.   "
107606|NCT01877811|"     This is a first-in-human, multicenter, open-label study consisting of 2 phases. Phase 1 is a     dose escalation study of RXDX-105 (formerly known as CEP-32496) in patients with advanced     solid tumors aimed at defining the recommended Phase 2 dose (RP2D) and schedule for     administration. Phase 1b is a dose expansion in approximately 90 patients with advanced solid     tumors with specific histologies and/or molecular alterations of interest. Patients in Phase     1b will be treated at the RP2D determined in Phase 1.   "
107607|NCT01877798|"     Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock     therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio     (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The     purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen     saturation (ScvO2) in the treatment of severe sepsis and septic shock.   "
107608|NCT01877785|"     This randomized, double-blind, placebo-controlled, single-ascending dose study will assess     the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy     volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching     placebo.   "
107609|NCT01877772|"     This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff     repair; bone trephination. Trephination is a procedure that involves making small     perforations in the bone that the tendon is repaired to. The rotator cuff is repaired by     sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is     used in addition to the standard method of repairing the rotator cuff tendon. The control     group will undergo the standard repair for rotator cuff tears.      It is the investigators' hypothesis that healing rates in patients who undergo bone     trephination will be higher compared with surgery without trephination in arthroscopic     rotator cuff repair at 24 months post-operatively.   "
107610|NCT01877759|"     Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral     infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the     liver), or by blockage of biliary system such that the liver undergoes progressive scarring     that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive     hepatic fibrosis characterized by distortion of the hepatic architecture and formation of     regenerative nodules. For this condition of disease the liver transplantation is one of the     only effective therapies available ,but due to lack of donors, surgical complications,     rejection, and high cost are it`s serious problems.      Presently stem cells are used to be a one of the treatment for the same. So our approach is     to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis     .   "
107611|NCT01877746|"     The aim of this study is to compare the effect of combined immunosuppressive therapy given on     the top standard medical therapy of chronic heart failure according to current guidelines     with standard medical therapy of chronic heart failure alone in patients with infammatory     cardiomyopathy (ICM).      Suitable subjects are characterized by EMB established presence of myocardial inflammation /     negative polymerase chain reaction assay (PCR) findings of cardiotropic infectious agents and     with varying duration of heart failure symptoms and left ventricular (LV) systolic     dysfunction (phase A).      Further, to compare the effect of two regimens of combined immunosuppressive therapy in these     patients with ICM (phase B).   "
107612|NCT01877733|"     The purpose of this study is to investigate the effect of maximal strength training (MST)     compared to standard rehabilitation in patients operated with total knee arthroplasty.     Previous studies report reduced physical function and muscle strength despite successful     surgery inserting an artificial implant.      Furthermore, great loss of muscle strength has been found in these patients in the early     postoperative phase.      The study is a randomized controlled trial. The investigators hypothesize that MST will     increase muscle strength and physical function more than standard rehabilitation.   "
107613|NCT01877720|"     Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator     interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV     (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal     cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial     of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway     pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing,     inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator     assistance, and the asynchrony index (AI).   "
107614|NCT01877707|"     To identify whether home monitoring of multiple physiological parameters and biomarkers in     sputum could provide advanced warning of an infective exacerbation or treatment failure     before changes in patient-reported symptoms.   "
114168|NCT01791491|"     The purpose of this study is to evaluate how well adolescent kidney transplant patients     tolerate a single dose of belatacept they receive at least 6 months after transplant surgery,     and how their body handles the drug.   "
107616|NCT01877681|"     Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care     in health centers. The chronic wound care by skilled personnel is key to healing and     management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC)     can improve the effectiveness of interventions and cost savings.      Objective: To evaluate the effectiveness and costs reduction after the implementation in PC     setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses     for the management of PU in patients in home care setting.      Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza     will be randomly assigned to two parallel groups: experimental group and control group. Each     nurse will recruit at least 1 new patient in home care with PU in stage II-III. The     intervention will consist of a telematic advice from the reference nurse regarding chronic     wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a     minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of     the intervention, multilevel models or linear mixed models to take into account the     auto-correlation at the individual level and nurse, will be used   "
107617|NCT01877668|"     This is a 12-month study investigating the effectiveness and safety of tofactinib in treating     the signs and symptoms of active psoriatic arthritis and improving physical function and     preserving bone structure in patients with an inadequate response to a traditional,     nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.   "
107618|NCT01877655|"     The purpose of the study is to evaluate the efficacy of ASP0113 compared with placebo as     measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD)     through 1 year post-transplant. Safety of ASP0113 in subjects undergoing allogeneic HCT will     also be evaluated.   "
107619|NCT01877642|"     This study will compare the safety and effects over time for giving both ADASUVE and     lorazepam (intramuscular) compared to that of each agent given alone.   "
107620|NCT01877629|"     To explore the pharmacokinetics (PK) of a single dose of two different formulations of     ACT-129968, i.e., tablet versus capsule and to evaluate the safety and tolerability of a     single dose of two different formulations of ACT-129968, i.e., tablet versus capsule.   "
107621|NCT01877616|"     Little is known on the prevalence of sleep disorders and their role in the increased     prevalence of cardiovascular diseases in the developing world. We To assess the prevalence of     major sleep disorders in a rural South American population, and to determine whether these     conditions are associated with a poor cardiovascular health or with the occurrence of stroke     or ischemic heart disease. This is a three-phase, population-based, door-to-door survey in     Atahualpa. During phase I, all residents aged ≥40 years will be screened with validated     Spanish versions of five questionnaires to evaluate major sleep disorders. In phase II,     neurologists will examine persons suspected of having a sleep disorder and a random sample of     negative individuals to assess the prevalence of these conditions and to validate the     accuracy of questionnaires. In phase III, patients with a confirmed sleep disorder will     undergo nocturnal polysomnography for achieving a more specific diagnosis. The occurrence of     sleep disorders will be correlated with the cardiovascular health of the population as well     as with the presence of stroke and ischemic heart disease. This epidemiological study may     prove cost-effective in improving sleep conditions of people living in rural areas of     developing countries, and may be used as a model for the evaluation of sleep disorders and     their cardiovascular correlates in these populations.   "
107622|NCT01877603|"     Irisin is a signaling protein that is released into the blood from skeletal muscle after     proteolysis of the membrane protein FNDC5 . FNDC5, encoded by the Fndc5 gene. Irisin activity     on subcutaneous white adipose tissue, both in culture and in vivo, stimulated UCP1 expression     and induction of brown adipocytes in white adipose tissue depots, a process known as white     fat ''browning''. Irisin increases total energy expenditure in animal models, and irisin     expression in mice fed a high fat diet resulted in a significant improvement in glucose     tolerance and a reduction in fasting insulin levels. Collectively, these data suggest that     decreased serum irisin levels may be associated with the development of insulin resistance     and Type 2 diabetes. Indeed, some studies showed that irisin levels were decreased in newly     diagnosed Type 2 diabetes.      Endothelial dysfunction is an early physiological event in atherosclerosis. However, to date,     no data are available on the relationship between circulating irisin and endothelial     dysfunction in diabetes. Therefore, the investigators hypothesized that circulating irisin     level is associated with endothelial dysfunction.   "
107623|NCT01877590|"     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,     mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2     diabetes is understandably directed toward treating coronary artery conditions. However there     are other treatable culprits in these patients.      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even     in the absence of hypertension. It is a strong predictor of cardiovascular events and     all-cause mortality. Regression of LVH has been associated with an improved prognosis,     independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality     in type 2 diabetes with CAD might will be reduced if the investigators can find novel     therapies to regress LVH.      Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can     improve endothelial function in diabetic conditions. Hence, the main aim of this study was to     assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.   "
107624|NCT01877577|"     This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and     quality of life in IBD patients deficient in vitamin D, and also help determine the optimal     dose of vitamin D3 for them.      Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve     their quality of life and decrease IBD activity.   "
107625|NCT01877564|"     The purpose of this research is to determine the effects of Metformin, a well tolerated drug     widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.   "
108578|NCT01864811|"     A randomized control trial investigating if an early intervention program of modified     Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age     will improve hand function in children with risk for developing cerebral palsy.   "
116524|NCT01760694|"     To assess the ability of a combination of updated and approved modalities in the treatment of     first line pancreatic cancer patients to increase the time to Progression Free Survival   "
107626|NCT01877551|"     Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected     people than the general population. Protease inhibitor booster antiretroviral therapy     (PI-ART) which is used by ~50% of HIV infected people in the USA is an established risk     factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt,     improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these     benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin     action in people with HIV who are receiving PI-ART. Further, this project will clarify the     molecular mechanisms responsible for these improvements potentially benefiting society,     irrespective of HIV status.   "
107627|NCT01877538|"     AIM: To validate the tracer [11C]donepezil for use in the parasympathetic nervous system.      MATERIALS AND METHODS: The Investigators will include 7 healthy males aged 45-75 in our     study. The participants will receive a careful medical examination, including a neurological     examination, as part of the inclusion process. The subjects also have an MRI scan of the     brain. PET/CT scans with [11C]donepezil are conducted. Six subjects will receive two PET/CT     scans - once for the upper abdominal region and once for the head region two evaluate dynamic     binding characteristics of the tracer in internal organ. Additionally, one single subject     will receive 5 consecutive whole body PET scans to estimate radioactive dosimetry of this     tracer.      PERSPECTIVES: The study will potentially result in the development of a PET ligand for     imaging the parasympathetic nervous system. This will have applications for research in     Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic     nervous system is involved   "
107628|NCT01877525|"     Resect and discard (RD) is a new paradigm for management of diminutive colorectal polyps     wherein histology is determined by real-time endoscopic imaging; polyps are then resected and     discarded rather than sent for histopathological review. The aims of this study were to     compare the surveillance recommendations between RD and the standard of care where polyps are     sent for histopathological review in a mixed setting of academic and community     gastroenterologists and to evaluate the diagnostic performance of an RD program for     management of diminutive polyps.   "
107629|NCT01877512|"     Rationale: Abnormally low and high levels of insulin-like growth factor-I (IGF-I) are both     associated with increased metabolic risk. Since (U-shaped) associations of IGF-I, within the     normal range, have also been found with cardiovascular risk factors and disease in the     general population, it would be interesting to investigate if this association can also be     found in growth hormone deficient (GHD) adults treated with Growth Hormone (GH). This could     be of interest for endocrinologists prescribing GH in clinical practice because strict dosing     may become even more important. Next to that, scientific evidence for clinical practice is     wanted.      Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid     profile; secondary objectives: remainder) we investigate the effect on glucose metabolism,     physical performance, and neuropsychological functioning of different levels of IGF-I in GH     treated GHD men and women.      Study design: Open-label randomized trial.      Study population: At least 32 subjects, both childhood as adult onset GHD men and women,     receiving GH treatment for at least one year, with an age between 20 and 65 years.      Intervention: At entry subjects are already receiving GH treatment according to general     clinical practice, and are expected to demonstrate an IGF-I concentration of 0 - 1 SD score     (SDS) (normal dose). The group of men and group of women will be randomized to receive either     a decrease of their regular dose of GH treatment (IGF-I target level of -2 - -1 SDS) (low     dose), or an increase of their regular dose, (IGF-I target level of 1 - 2 SDS) (high dose)     for at least 24 weeks.   "
107630|NCT01877499|"     Two recent randomized controlled trials (RCT) on online hemodiafiltration (HDF) did not show     a treatment effect on patient survival when compared with low‐ or high‐flux hemodialysis.     Interestingly, post‐hoc (on treatment) analyses from both trials unequivocally showed reduced     mortality in the patient group achieving the highest convection volumes. Moreover, a third     trial recently found a significant 30% decrease in mortality when HDF was applied with a mean     convection volume of 23.7 L per session, which was somewhat higher than the average volumes     reached in the aforementioned trials. Altogether, these findings support the concept of a     dose-response effect, in which a minimally delivered convection volume is required in order     to show a survival benefit.      Hence, the question arises whether high convection volumes are achievable in the majority of     patients. The aim of this study is thus to test the following hypothesis: high‐volume (>22     liters per treatment) post-dilution on‐line hemodiafiltration (HDF) is achievable in the     majority (>75%) of patients treated with chronic intermittent hemodialysis. This will be done     through the use of a dedicated standardized protocol, in which the three most important     determinants of convection volume will be successively optimized: treatment time, blood flow     rate and filtration fraction.   "
107631|NCT01877486|"     To determine the efficacy of cryoablation alone in patients with paroxysmal atrial     fibrillation who have been pretreated with dofetilide and converted from persistent atrial     fibrillation.   "
107632|NCT01877473|"     The hypothesis of this study is that by facilitating reverse atrial remodeling with     maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a     simple pulmonary vein isolation (PVI) with results equivalent or superior to more complex     atrial ablation for patients with persistent AF.   "
107633|NCT01877460|"     This study compares the effects of isovolumetric (325 ml) preloads of chocolate milk     supplemented with sodium alginates at incremental doses on inter-meal glucose levels,     appetite scores and food intake in healthy adult men. The findings of this study will     illustrate whether the addition of sodium alginate to chocolate milk will improve the     glycemic properties of chocolate milk and will potentiate its satiating characteristics. This     study will also elucidate whether sodium alginates, incorporated into chocolate milk, will     influence glycemia, appetite sensations and food intake in a dose-dependent manner. It is     hypothesized that there will be a synergy between milk and sodium alginate beyond either     alone. When combined with milk components, sodium alginate is expected to improve glycemia     and induce satiety more than does either milk alone or alginate alone.   "
107658|NCT01877265|"     This study looks at the amount of LY2605541 in the body after it is injected under the skin.     The study has 3 periods, each lasting 10 days. Each participant will receive one injection in     each period. At least 14 days will pass between each injection.   "
107634|NCT01877447|"     Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application     of a weak electrical current over the scalp through two electrodes - the anode, which     facilitates neuronal depolarization, and the cathode, which leads to neuronal     hyper-polarization. Recently, several open-label and sham-controlled clinical trials applied     daily tDCS sessions for the treatment of major depressive disorder (MDD). Theoretically, tDCS     displays depression improvement through anodal stimulation over the left dorsolateral     prefrontal, inducing excitability-enhancing effects over this area, which is hypoactive     during the acute depressive episode. The present study is aimed at comparing two different     tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with     cathode placed over an extra cephalic area; (2) active cathode placed over the right     dorsolateral prefrontal cortex with anode placed over an extra cephalic area.   "
107635|NCT01877434|"     Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder     diseases with improved functional outcome. This study has evaluated patients operated with     reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported     outcome, clinical and radiological examination, complication and reoperations. The radiologic     phenomenom and clinical impact of scapular notching (SN) and arm length difference has been     evaluated.   "
107636|NCT01877421|"     This study is to assess the safety and tolerability of single doses and multiple doses in     reducing plaque and gingivitis when delivered in a chewing gum formulation.   "
107637|NCT01877408|"     To identify a minimally-invasive surgical circumcision technique for men, which is easy to     learn and perform, is safe, and is associated with high patient satisfaction and excellent     cosmetic results.   "
107638|NCT01877395|"     The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies     Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration     of human rabies immunoglobulins (Imovax® Rabies).      Primary Objectives:        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of          subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international          units (IU)/mL at Day 14.        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5          IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI)          of at least 97%.      Secondary Objectives:        -  To assess the clinical safety of each vaccine after each vaccine injection when          administered in a simulated post-exposure schedule.        -  To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day          14.   "
107639|NCT01877382|"     This will be a Phase 1, open-label study of DS-3032b to assess its safety and tolerability,     identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess     its pharmacokinetic (PK)/ pharmacodynamic (PD) properties in subjects with advanced solid     tumors or lymphomas.      Approximately 5 US sites are planned for Part 1 (Dose Escalation). Approximately 10 US sites     are planned for Part 2 (Dose Expansion).   "
107640|NCT01876407|"     The purpose of this study is to evaluate the effectiveness of using to low intensity laser as     an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and     chemotherapy.   "
107641|NCT01876394|"     The purpose of the study is to examine the effect of consuming 50g of fat from 5 different     sources (coconut, canola, grapeseed, chia, and butter) on arterial stiffness, blood pressure     and blood glucose levels. It is hypothesized that butter will have the most detrimental     effect on acute vascular function. Canola, grapeseed and chia oil with their decreased     content of SFA are hypothesized to impair vascular function to a lesser extent.   "
107642|NCT01876381|"     To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in     patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using     variables, such as daily urine volume and increase in interval body weights between     hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days     of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period   "
107643|NCT01876368|"     This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in     essential hypertensive patients not adequately responsive to olmesartan   "
107644|NCT01876355|"     Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke     delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of     GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that     this therapy is effective and safe.      Objective: The objective of this study is to compare the effect of clonidine with placebo on     the occurrence and duration of delirium in mechanically ventilated ICU patients.      Study design: Prospective randomised double-blind placebo controlled intervention study in     115 patients.      Study population: All patients >18 years old, intubated mechanically ventilated and sedated     at inclusion.      Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen.     Comparison: NaCl 0,9 % infusion as placebo.      Main study parameters/endpoints: The main study parameter is the total number of awake and     delirium-free observation periods the first 7 days after randomisation. An observation period     is a nursing shift of 8 hours.   "
107645|NCT01876342|"     Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair     without mesh or laparoscopic technique with mesh have been advocated in the treatment of     sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open     technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis     is that laparoscopic technique is less painfull than open surgery for repair of sportsman's     hernia.   "
107659|NCT01877252|"     The principal research question is which treatment modality between open surgical,     endovascular and conservative therapy is the most effective in terms of limb salvage,     survival and reinterventions in patients with critical limb ischemia   "
107660|NCT01877239|"     This is a prospective non-interventional observational study to evaluate the treatment of     moderately active RA patients in every day clinical practice in Austria. Patients will be     observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI     remission after 24 weeks.   "
107661|NCT01877226|"     The purpose of this study is to evaluate pharmacokinetics (explores what the body does to the     drug), safety and tolerability of single and multiple-dose of tapentadol in healthy     participants.   "
107646|NCT01876329|"     A review of the literature reveals that very few studies have assessed the potential     co-existence of vitamin B12 deficiency due to gastric parietal cell autoantibodies. While     Segal et al. in 2004 published a study which found that 49% of patients with RA had vitamin     B12 deficiency, no assessment of the etiology or the presence of autoantibodies was made.     While Goeldner et al. in 2011 and Datta et al. in 1990 demonstrated that anti-gastric     parietal cell antibodies (anti-GPC Ab) were found in <5% to 28% of RA patients respectively,     no additional testing was implemented to determine the significance, specifically whether or     not the presence of anti-GPC Ab related to vitamin B12 deficiency.      The purpose of this study is to determine the prevalence and metabolic significance of     anti-GPC Ab in three cohorts: (1) a group of patients with Rheumatoid Arthritis, (2) a group     of patients with autoimmune thyroid disease (AITD), and (3) a group of patients with neither     RA or AITD. To determine the significance of the presence of anti-GPC Ab, testing of the     current serum B12 level along with a metabolite dependent on adequate vitamin B12 levels     (Methylmalonic acid) will be tested.   "
107647|NCT01876316|"     The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese     Healthy Subjects   "
107648|NCT01876303|"     This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing     sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help     doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify     biomarkers related to cancer.   "
107649|NCT01876290|"     The investigators want to test if it is indicated to associate dexamethasone and ondansetron     in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.   "
107650|NCT01876277|"     In adolescence, the effects of cancer and its treatment can lead to bodily changes such as     hair loss, weight loss or gain, amputations, scars and developmental delay. As treatments for     childhood cancers improve and life expectancy increases, more adolescents have to deal with     the effects of cancer and the treatment on their bodies throughout their lives.      Body image can be defined as The mental image we hold of our bodies. There are two aspects     to this, how we see our size/shape/weight etc, and then how we feel about this. Often the     actual change in body does not always predict how people cope with it, or how they feel about     it.      Prior research suggests, and clinical experiences suggests that body image issues arise for     at least some adolescents with cancer, however it is unknown whether a disturbance in body     image is seen as distressing for the adolescent, or how this affects them psychologically.      Body image problems were always seen as a typically female problem, and therefore researchers     have often neglected to look at the issues for men. There is currently no research     specifically addressing the impact of body image in adolescent boys with cancer.      This research will involve interviewing adolescent males with cancer with the aims to find     out;        1. What the body image issues are, if any for this group.        2. How any body image issues might affect them, particularly psychologically.        3. What helps or hinders this group maintain a positive body image, or stop it having a          negative impact on them psychologically.      It is hoped that this will help to inform psychological treatments for body image     difficulties in the future.   "
107651|NCT01877356|"     The purpose of this study is to compare unilateral spinal anesthesia using hyperbaric     Prilocaine with classical bilateral spinal anesthesia using plain Prilocaine according to     block characteristics and quality of micturition, standardized to the subjects own functional     bladder capacity. Our hypothesis is that unilateral spinal anesthesia will provide faster     time to micturtition and discharge, lesser hypotension and lesser micturition problems.   "
107652|NCT01877343|"     This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt     table and a stress test will be performed in a total of 4 different positions. Their blood     pressure will be measured at each position. Also, a pulse oximeter will be placed on the     forehead to measure pulse rate and strength. These results will be compared to cardiac     functional classifications defined by New York Heart Association (NYHA) criteria for adults     and New York Pediatric Heart Failure (NYPHF) index for our pediatric age patients. The     primary aim of this initiative is to assess the discriminatory value of a cardiac functional     health classification based upon the degree of dependency of cardiac function on changes in     cardiac preload and afterload circulatory volume.   "
107653|NCT01877330|"     This is a prospective randomized clinical trial to determine where is the optimal location     for local anesthetic injection for ultrasound guided interscalene nerve blocks. The     investigators are investigating if local anesthetic deposited between the nerve roots is more     effective than local anesthetic deposited in the interscalene groove.   "
107654|NCT01877317|"     The purpose of this clinical study is to validate the comparability of prescription formula     fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting     of hearing aids based on hearing loss screening (mild to moderate hearing losses) using     in-situ audiometry, provided and executed through the mobile medical app.   "
107655|NCT01877304|"     To compare deposition between two modalities of nebulization   "
107656|NCT01877291|"     Background: Smoking is a key factor for development and progression of chronic obstructive     pulmonary disease (COPD). Although persons with COPD often have concomitant nasal disease,     there are few studies that report physiological or inflammatory changes in the upper airways     in young asymptomatic smokers. The investigators investigated physiologic and inflammatory     changes in the nasal and lower airways of young smokers and if these changes were related to     smoking history.      Methods: Seventy-two subjects aged ≤ 35 years (32 healthy nonsmokers and 40 young smokers)     participated in this study. The investigators measured nasal mucociliary clearance (MCC),     nasal mucus physical properties, cell count, myeloperoxidase and cytokines concentrations in     nasal lavage fluid, exhaled breath condensate (EBC) pH and lung function.   "
107657|NCT01877278|"     The aim of the study is to evaluate the efficacy of a wearable device using pulse     electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS)     and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients     affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion     reduction, when present and to evaluate pain intensity changes corrected by pain threshold     measured by pressure algometry.   "
137863|NCT01480245|"     The purpose of this study is to explore long-term safety, tolerability and efficacy of     GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.   "
107662|NCT01877213|"     One third of the costs of medical care for people with diabetes are related to     hospitalization. Difficult diabetic patient, i.e. those with very high HbA1c, patients >     75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high     rate of readmission when discharged at home after an initial hospitalization related to     diabetes or its complications. The objective of the study is to test if a coaching with a     care coordinating team after hospital discharge would decrease diabetes-related     rehospitalization rate compared with usual care.   "
107663|NCT01877200|"     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the     the current status of diabetes management, control, and complications in diabetic subjects     with type 2 diabetes in Bangladesh.   "
107664|NCT01877187|"     The purpose of this study is to determine the whether Lipiodol can be used as an imaging     biomarker, predicting tumor response to therapy in patients with primary and metastatic liver     cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard     of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a     carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol     is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery,     causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3     and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of     liver function and tumor markers).   "
107665|NCT01877174|"     This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be     enrolled. The purpose of the study is to evaluate any debris that may be captured in the     inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a     transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses     reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE     marked and is used in routine practice for the purpose of this study.   "
107666|NCT01877161|"     Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.   "
107667|NCT01877148|"     The present study aims to investigate the effect of transcranial direct current stimulation     (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed     that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this     way, this study will combine tDCS with physiotherapy in order to enhance the motor     rehabilitation and the quality of life.   "
107668|NCT01877135|"     Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions,     and factors associated with this AC. A retrospective cohort study will be conducted     (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of     anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC     will be calculated. Factors associated with AC will be estimated using a multivariate Cox     regression model.   "
107669|NCT01877122|"     Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be     used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of     life)of two devices at 3 months follow-up.   "
107670|NCT01877109|"     The purpose of this study is to establish a model which can predict the treatment outcome and     the risk of treatment-related morbidity in patients with lymphoma.   "
107671|NCT01877096|"     The purpose of this study is to begin to examine the efficacy of a motivational interviewing     intervention to increase African Americans' screening colonoscopy rates. The results from     this pilot study will allow us to estimate the magnitude of the intervention and mediation     effect sizes.   "
107672|NCT01877083|"     This is a Phase 2, open-label, safety and activity study of lenvatinib in subjects with     KIF5B-RET-positive adenocarcinoma of the lung and other confirmed RET translocations. At     least 20 subjects with KIF5B-RET will be treated and will receive lenvatinib at a starting     dose of 24 mg orally, once per day. Additional subjects with other RET translocations will be     treated with lenvatinib at a starting dose of 24 mg orally, once per day. The study will     consist of 3 phases: The Pretreatment Phase, The Treatment Phase and the Extension Phase. The     Pretreatment Phase will include screening procedures and eligibility assessments. The     Pretreatment Phase consists of a Screen 1, Screen 2 and Baseline Period. The Treatment Phase     will begin when the subject has met all eligibility criteria on Day 1 of the first Treatment     Cycle. The Treatment Phase contains the Treatment and Follow-up Periods. The Extension Phase     will begin for subjects who received treatment in the study (either in the Treatment Period     or Follow-up Period) at the time of database cutoff.   "
107673|NCT01877070|"     The purpose of this study is to collect information on how patients and their partners/close     allies make treatment decisions when they have been diagnosed with early stage prostate     cancer.   "
107674|NCT01877057|"     The increasing prevalence of overweight and obesity among the population contributes to     increased incidences of chronic metabolic diseases. Healthcare costs related to these     diseases are rising; prevention or delay of onset of disorders associated with overweight is     needed. Food ingestion exerts a transient suppressive effect on appetite and further food     intake by releasing gastrointestinal hormones. Proteins have been shown to be more satiating     than carbohydrates and fat. Intraduodenal administration (via a naso-duodenal intubation) of     pea protein has been shown to reduce food intake and increase satiety hormone levels in     humans, in contrast to orally dosed (unprotected) pea protein. In the present study we aim to     investigate the effects of human gastric fluid on the degradability of five different     protected pea protein products. Further, in an ex vivo experiment on freshly obtained human     duodenum tissue applying Ussing chamber technology; we aim to investigate the intestinal     satiety hormone release by the five different prototypes. The prototype that is less degraded     by human gastric fluid and is most effective in intestinal satiety hormone release will be     used in a future clinical trial.   "
107693|NCT01876810|"     The purpose of this study is to investigate the effect of gemfibrozil on nicotine     reinforcement and cue-elicited craving. Other objectives of this study include screening for     the ability of gemfibrozil to aid smoking abstinence during a brief quit attempt and     examining the validity of using laboratory measures of tobacco dependence to predict smoking     abstinence. It is hypothesized that gemfibrozil will result in diminished nicotine     reinforcement, an attenuated response to smoking cues, and an increase in smoking abstinence     compared with placebo. It is also hypothesized that the laboratory measures will prove valid     in predicting abstinence.   "
107675|NCT01877044|"     The higher prevalence of overweight and obesity among the population contributes to increased     incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic     inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue     and 2) alterations in intestinal microbiota composition and associated increase in intestinal     permeability. Healthcare costs related to these diseases are rising; prevention or delay of     onset of disorders associated with overweight is needed. Administration of wheat     arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota     composition and have beneficial effects on gut epithelial barrier, especially on permeability     and innate immune function.      Objective: To assess the effects of NAXUS on intestinal barrier function, immune system     performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance     of the product in different doses will also be investigated.   "
107676|NCT01877031|"     We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle     to look at the time taken to place a central line, or specifically the time taken to place a     needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a     central line.   "
107677|NCT01877018|"     The implementation of screening programs for colorectal cancer by screening for fecal occult     blood has proven effective in reducing the incidence and mortality from this type of     neoplasms. However, to ensure the efficiency of the programs require population participation     rates of at least 50%. Experiences in our country show that the population participation is     far from this recommended minimum number.      Interventions to promote preventive activities in primary care are well received by the     population; in the case of colorectal cancer, direct recommendation of primary care     professionals to carry out the screening is one of the factors with greatest impact on     increasing population participation in such programs. Care overload, circuit design for     screening without the direct intervention of primary care professionals and the multiplicity     of tasks that they must face, are elements that influence the low recommendation for     screening in the target population who consults for any other reason.      The introduction of specific reminders in electronic medical record (in widespread use in     primary care), as a tool to facilitate and encourage direct referral by physicians and nurse     practitioners to perform colorectal cancer screening will mean an increase of at least 10% in     participation of the target population, increasing the efficiency of screening programs. The     introduction of this new software tool will have good acceptance and increase compliance with     recommendations from health professionals.   "
107678|NCT01877005|"     Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in     patients with advanced Hodgkin's lymphoma for whom no curative option is available.   "
107679|NCT01876992|"     The investigators know that metformin works at the level of the cells in the body by acting     on a protein called Cyclic amine monophosphate- Response Binding Elements (CREB) binding     protein or Constitutive Reverter of eIF2α Phosphorylation (CREP) Binding Protein (CBP). What     the investigators do not know is how this process is affected when the dose of the metformin     is increased or changed.      Currently the same doses of metformin are often used in both children and adults, but it is     possible that the dose of metformin should be based on age and weight. Understanding how CBP     works could potentially help us to tailor metformin treatment individually for patients based     on their age, weight and CBP response.   "
107680|NCT01876979|"     Determining the cost effectiveness, based on the time duration of application, of two methods     of wiring the jaws together during surgery to repair mandible fractures. One technique is     more expensive but faster in application, while the other is less expensive and takes more     time to apply.   "
107681|NCT01876966|"     The purpose of this study is to investigate the pharmacokinetic interaction between     etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine in     healthy Human Immunodeficiency Virus- (HIV-)negative patients. 'Pharmacokinetic interaction'     means that one medication can influence the absorption and elimination from the body of the     other medication.   "
107682|NCT01876953|"     This phase I/II trial studies the side effects and best dose of dasatinib when given together     with cytarabine and idarubicin hydrochloride and to see how well they work in treating     patients with acute myeloid leukemia that is likely to come back or spread. Dasatinib may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as cytarabine and idarubicin hydrochloride, work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving dasatinib together with cytarabine and idarubicin hydrochloride may be a     better treatment for acute myeloid leukemia.   "
107683|NCT01876940|"     The goal of this prospective randomized study is to compare the effect of operator experience     on the ability to use fiberoptic-guided intubation in children less than two years old, with     and without the use of an air-Q as a conduit. The question the investigators are trying to     answer is: Does the operator experience make a significant difference in the time for     successful fiberoptic guided tracheal intubation with and without the use of an air-Q     intubating laryngeal airway?   "
107684|NCT01876927|"     Study design:      Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up     Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up      Population:      Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially     resectable adenocarcinoma of the stomach.      Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%,     alpha=0.05 (two sides), beta=0.2)      Treatment Plan:      Treatment will be administered for 4 and 2 cycles before surgery in arm A and B,     respectively, and in arm B for a further 2 cycles after surgery unless progression or     unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go     off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative     cycle, patients will undergo surgery.      After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.      DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2     daily for 2 weeks      Cycles repeated every 3 weeks      Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria     (version 1.1).      Duration of Study:      Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years   "
130119|NCT01581866|"     The objective of this study is to compare the rate and extent of absorption of ziprasidone 20     mg capsules versus Geodon 20 mg capsules under fasting conditions.   "
107685|NCT01876914|"     Diabetic Macular Edema (DME), which can happen as a complication of diabetes, occurs when     fluid and proteins collect in the macula (the yellow central area of the retina). The fluid     can cause swelling which in turn can lead to worsening central vision. The purpose of this     study is to see if the study device (Swept Source Optical Coherence Tomography or SS-OCT) is     able to diagnose DME as well as an already approved imaging procedure called fluorescein     angiography (FA). FA is standard of care and would be conducted regardless of study     participation. The dye used in FA, which can cause allergic reactions in some patients and is     not used in pregnant women, is not needed with the study device. Another purpose of the study     is to avoid the risk of administering the FA dye if possible.   "
107686|NCT01876901|"     Hypothesis:      In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one     and a half times higher in men than in women. The average age of diagnosis is 65. Unlike     colon cancer, technical management remains challenging with unresolved operating     difficulties. Morbidity of surgical procedures remains high with a very large number of     preventive or curative stoma derivations.      Reference in surgical treatment is total excision of the rectum and its mesentery, followed     by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate     of fistula that results is reported in the literature between 15 and 25%.      An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on     retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of     fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and     mortality are reduced, and patient's quality of life greatly improved. Direct costs     (consumables intraoperative, hospitalization, stoma complications) and indirect     (pocket-fitting stoma) are greatly reduced.      This study is a multicentre, two arms, phase 2 clinical trial.   "
107687|NCT01876888|"     The aims of this study were to perform cultural adaptation of the MedRisk Instrument for     Measuring Patient Satisfaction With Physical Therapy Care (MRPS) instrument and provide     information regarding the factor structure, group-level reliability, and criterion-referenced     validity of the instrument in Turkish speaking patients.   "
107688|NCT01876875|"     Low-grade systemic inflammation associated with obesity may worsen the clinical course of     psoriasis. Both a low-calorie diet and nutritional supplementation have been shown to have an     impact on the clinical course of psoriasis, including an anti-inflammatory effect of n-3     polyunsaturated fatty acids (PUFAs). This study aimed to assess the effectiveness of an     energy-restricted diet, enriched in n-3 PUFAs and poor in n-6 PUFAs, on metabolic markers and     clinical outcome of obese patients with psoriasis.      Methods: Forty-four obese patients with mild-to-severe plaque-type psoriasis treated with     immuno-suppressive drugs were randomized to assume either their usual diet or an     energy-restricted diet (20 kcal/kg/ideal body weight/day) enriched of n-3 PUFAs (average 2.6     g/d). All patients continued their immuno-modulating therapy throughout the study. End-point     measures included anthropometric, biochemical and clinical parameters at baseline, 3 and 6     months.   "
107689|NCT01876862|"     During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral     Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable     reservoir.      Recent studies showed that a low reservoir is associated to a spontaneous virologic control     in three specific categories of patients:        -  Elite Controllers: these rare patients are able to spontaneously maintain an HIV-RNA          viral load below 50 copies/mL and elevated CD4 counts without any treatment. These          patients belong to the B27/B57 haplotypes associated to a reduced risk of HIV          contamination but these haplotypes are very rare in the global population (0,3 %)        -  Visconti patients: early-treated patients, during the primo-infection stage. After 3          to 5 years of treatment, these patients are able to maintain an undetectable HIV-RNA          viral load.        -  Salto patients: these patients are treated a bit later compared to the Visconti          cohort, when their CD4 count was above 350 cells/mm3 and their HIV-RNA viral load below          50 000 copies/mL. The follow-up of these patients showed the same capacity of control of          the HIV infection for at least 2 years following treatment interruption.      Taking into account these 3 categories of patients which common characteristics is a low     reservoir, our objective is to answer the 2 following questions:        1. Is it possible to discontinue the treatment in chronically-infected patients with a          normal immune system and with an undetectable HIV-DNA reservoir?        2. Is a low viral reservoir predictive of a treatment-free remission of the HIV infection          in chronically-infected patients?      The main objective of the proof-of-concept ERAMUNE-03 trial is to evaluate the proportion of     patients in success (i.e. able to maintain a virologic and an immunologic control of the     infection) after treatment discontinuation, failure is defined as:        -  An HIV-RNA viral load > 400 copies/mL on 2 consecutive tests starting from Week 4        -  Or CD4 count < 400 cells/mm3 on 2 consecutive measures starting from Week 4        -  Or the onset of an AIDS-related event   "
107690|NCT01876849|"     The aim of this study is to assess the long-term safety of exenatide in patients with type 2     diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study     H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies     H8O-MC-GWAA and H8O-MC-GWAD.   "
107691|NCT01876836|"     1. i-gel        2. C-LMA      Compare the effect on gastroeosephageal reflux Postoperative complicatios.   "
107692|NCT01876823|"     Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause     of disability and death in the elderly. Although a number of theoretical causes exist, the     etiology of AD is still unknown. Consequently, the focus of treatments has been palliative,     designed to ameliorate AD symptoms. Recent efforts, however, have revealed some surprising     data suggesting that cholinesterase inhibitors (AchEIs), used over the last decade, and     recently released memantine (an N-methyl-D-aspartate (NMDA) receptor antagonist), may confer     protection to neurons. Thus, they may offer a slowing of cognitive decline and/or improvement     in behavioral symptoms associated with memory impairment.      Over the last decade, it has been well documented that mild cognitive impairment (MCI)     increases the risk of conversion to AD and that coincident depression and MCI (Dep-MCI)     further increases the risk 2 to 3 fold. The primary focus of this line of investigation is to     treat the very high risk to dement patient population with Dep-MCI, before they develop AD,     in the hopes of delaying AD onset.      Memantine had not been studied in DEP-MCI patients. Since treatment of these patients with     combined antidepressant and AChEIs has been associated with cognitive improvement in pilot     studies, we explore whether treatment of DEP-MCI with memantine in addition to antidepressant     treatment would benefit cognitive performance and lead to a low rate of conversion to     dementia. We evaluate the cognitive and antidepressant benefit of combined open-label     es-citalopram and memantine treatment over 48 weeks in a DEP-CI sample.   "
107701|NCT01876706|"     The purpose of the study is to evaluate procedure tolerability and surgical recovery     following the UroLift® system procedure when conducted with local anesthesia in subjects with     symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at     the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.   "
138821|NCT01467661|"     The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308     and, in the opinion of the Investigator, will continue to benefit from treatment.   "
107694|NCT01876797|"     This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and     prasugrel in healthy Korean male subjects.      The study is open label, one sequence, crossover design. In period 1, a single oral dose of     180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a     single oral dose of 60 mg prasugrel will be administrated.      After dosing each period, blood sampling for PK and PD assessment will be conducted.        1. Blood Sampling Times             1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose             2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose        2. Bioanalysis             1. plasma Ticagrelor             2. plasma AR-C124910XX (active metabolite of ticagrelor)             3. plasma R-95913 (inactive metabolite of prasugrel)             4. plasma R-13727 (active metabolite of prasugrel)        3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)        4. PK-PD Modeling analysis   "
107695|NCT01876784|"     Primary Objective:      To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when     compared to placebo in participants with differentiated thyroid cancer that is either locally     advanced or metastatic who are refractory or unsuitable for radioiodine therapy.      Secondary Objectives:        -  To determine the efficacy of vandetanib when compared to placebo in this participant          population as assessed by efficacy variables including duration of response (DOR),          objective response rate (ORR), change in tumour size (TS) and overall survival (OS).        -  To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and          potentially investigate any influence of participant demography and pathophysiology on          vandetanib PK.        -  To demonstrate an improvement in time to worsening of pain (TWP) in participants treated          with vandetanib when compared to placebo in this participant population.        -  To evaluate the safety and tolerability of vandetanib treatment in this participant          population.   "
107696|NCT01876771|"     Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis often delayed with     advanced metastases at presentation. In select patient populations, radioisotope therapy has     been shown to be a safe and effective palliative therapy. Lutetium-177 (Lu-DOTA-TATE) has     been used at the Cross Cancer Institute to treat 91 patients with NETS since August, 2010.     This study is being done because the investigators Lu-DOTA-TATE treatment is currently given     under Health Canada's (HC) Special Access Programme (SAP), with each individual treatment     requiring separate approval. HC has requested that the investigators conduct a clinical trial     with Lu-DOTA-TATE, with the goal of receiving approval to use Lu-DOTA-TATE as a marketed     treatment agent. There will be two groups of subjects: Group A (primary therapy) will have     somatostatin receptor positive tumours; Group B (secondary therapy) will be those subjects     who have currently been provided with Lu-DOTA-TATE under the SAP. All subjects will be     treated in a therapeutic stage using 8-12 week dosing for 4 cycles followed by a maintenance     stage using dosing at 22 to 26 week intervals for up to 8 cycles with a 22 to 26 week follow     up after the last dose. Safety will be assessed by vital signs, blood work, renal function     and adverse event collection.   "
107697|NCT01876758|"     Although electroconvulsive therapy (ECT) remains the most effective treatment for people with     severe depression, patients may experience a significant degree of persistent and/or     permanent memory problems following ECT. Many patients report the memory problems are the     most disturbing and serious side effect of ECT, and that such effects impact their quality of     life following treatment and their willingness to consent to further ECT needed to complete a     treatment course or to maintain remission. New developments in the field of cognitive     remediation have demonstrated the benefits of cognitive training to improve memory     performance in various conditions, such as epilepsy. However, these strategies have never     been applied to help patients regain memory after ECT. The investigators have designed and     piloted a novel cognitive program specifically targeted to the cognitive effects of ECT,     based upon a program tailored to people with seizure disorders, a group with memory problems     very similar to people who undergo ECT. This Memory Training for ECT (Mem-ECT) is designed to     help cognitive functions that may be compromised following ECT remain relatively preserved.     In addition, the intervention attempts to help ECT patients quickly regain their general     memory skills immediately following ECT. Recent results from our preliminary group of     patients who underwent ECT and memory training at New York Presbyterian shows no overall     decline in memory function following ECT. On the basis of these promising findings, the     investigators propose a more rigorous and larger study to confirm whether this novel memory     training program can help alleviate memory problems associated with ECT.   "
107698|NCT01876745|"     This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy     of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding     episodes and for the prevention of bleeding during surgery/delivery in patients with     Glanzmann's thrombasthenia (GT)/Glanzmann's disease.   "
107699|NCT01876732|"     Vitamin B12 has several important functions in the body, two of which are production of red     blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient,     abnormal red blood cells form. These cells are called megaloblasts. The end result is a     decreased number of red blood cells; a condition called anemia. Some symptoms of anemia     include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in     maintaining a healthy nervous system. Nerves are surrounded by an insulating material that     helps them conduct impulses. Patients with low B12 levels who receive this vitamin in     injection form, state that there quality of life is better. Anemia in Hemodialysis patients     is treated with Epogen, a synthetic material which helps your body make blood cells. The     investigators believe that if you have a low vitamin B12 level in your blood and the     investigators give you the vitamin during dialysis your requirement for epogen will be lower     and you will be able to produce blood cells better. When evaluating for Vitamin B12     deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood     test that will be performed and when this level is high and your vitamin B12 level is in the     low normal range the investigators can make a diagnosis of vitamin B12 deficiency.   "
107700|NCT01876719|"     This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced     titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio.     One-hundred twenty (120) patients are planned to be randomized. Each patient will receive     AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.   "
107704|NCT01876667|"     Clinical pharmacy specialists are in an ideal position to assist medical teams in the     management of patients with ischemic stroke. Given their extensive and specialized knowledge     regarding medication efficacy, safety, and cost-effective use as well as their ability to     critically review, interpret and apply the results from clinical studies to patient care,     clinical pharmacy specialists have the potential to have a significant impact on stroke care     delivery. There are numerous opportunities for clinical pharmacy specialists to become more     extensively involved in the delivery of care to these high-risk patients. However, to-date     there are few studies demonstrating the impact of clinical pharmacy specialists on outcomes     of patients with stroke Stroke is the third leading cause of death in the United States     (U.S.) and the most common life-threatening neurologic disorder.1 Stroke is a leading cause     of long-term disability and results in significant individual and societal financial burdens.     In 2006, stroke accounted for 1 of every 18 deaths and ischemic stroke accounted for 87% of     all strokes.1 In the U.S., out of the approximately 795,000 people who develop a stroke each     year, approximately 185,000 (23%) are recurrent events.1 After the first year, the average     annual risk for recurrent stroke is 4%.2 Patients who survive at least 30 days after a     first-ever stroke, have an average annual risk of death of 9.1%, much of the risk due to     nonstroke cardiovascular disease.      Despite the evidence supporting the use of various therapeutic interventions within the     ischemic stroke population, a significant proportion of patients continue to have     uncontrolled risk factors and remain undertreated.26-30 A recent prospective study of more     than 4933 high-risk patients reported that, as compared to patients with coronary artery     disease, patients with cerebrovascular disease are undertreated and thus less likely to     achieve blood pressure (45.3% vs. 57.3%; p<0.001) and lipid (19.4% vs. 30.5%; p<0.001)     targets.28 Although the reasons for the so-called treatment gap have not been explored     specifically within this population, data from studies within the coronary artery disease     population suggest that provider, patient and health care system factors likely all     contribute.      This will be the first, prospective, randomized study to evaluate the impact of a clinical     pharmacist disease management program on both surrogate and clinical outcomes for patients     with non-cardioembolic ischemic stroke.      This will be a randomized, controlled study comparing a clinical pharmacist-led disease     management intervention by the Clinical Pharmacy Cardiac Risk Service (CPCRS) to usual care     (UC).   "
107705|NCT01876654|"     Patient specific instrumentation is an alternative to conventional intra- and extra-medullary     guides to perform the femoral and tibial cuts in total knee replacement (TKR).      This instrumentation could provide a better alignment of a TKR, reduce blood losses and     operative time, and improve clinical outcomes.      The primary goal of this study is to compare the femorotibial mismatch angle of two groups of     patients: patients undergoing posterior stabilized, fixed bearing TKR with conventional     Attune® instrumentation (DePuy Johnson & Johnson, Warsaw, Indiana), versus patient undergoing     TKR with the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) cutting guide.   "
107706|NCT01876641|"     The purpose of this study is to see if the combination of Vemurafenib with Decitabine plus     Cobimetinib improves the low therapy response rate in subjects with malignant melanoma.   "
107707|NCT01876264|"     The trial will investigate if removing an additional length of small bowel will result in     lower risk of recurrence at the surgical join (anastomosis), thereby decreasing the need for     further surgery in the future.   "
107708|NCT01876251|"     This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel     combination in patients with advanced breast cancer. Preliminary information about the     efficacy of the combination will also be collected.   "
107709|NCT01876238|"     This research study will examine how patients with advanced breast cancer and their oncology     team communicate and plan ongoing care.The purpose of this study is to find out more about     care planning during advanced breast cancer. The study will see if certain aspects of     communication make a difference in how patients understand their illness.   "
107710|NCT01876225|"     The use of forced coughing during cervical punch biopsy may reduce pain & discomfort     associated with the procedure.   "
107711|NCT01876212|"     Current therapeutic approaches available for patients with advanced-stage melanoma remain     inadequate, and existing approaches including those involving immunotherapy with cytokines     and/or targeted strategies have resulted in disappointingly low rates of durable and complete     responses. Correcting immune dysfunction in advanced-stage melanoma patients using     tyrosine-kinase inhibitor (TKI) such as dasatinib is proposed to relicense the patient's     immune system to respond optimally to specific immunization. The integration of antigens     expressed by tumor-associated blood vessel cells provides a means to selectively target the     genetically-/antigenically-heterogeneous population of tumor cells in the advanced-stage     melanoma patient.      This is a single-center, prospective randomized Phase 2 trial evaluating the activity, safety     and immune effects of dasatinib given in combination with an autologous type-1 polarized     Dendritic Cell (αDC1) vaccine. The current trial represents a randomized Phase 2 study to     determine the activity and safety of intradermal (id) administration of αDC1s loaded with a     mixture of six TBVA-derived peptides at the time of, or immediately after, an initial therapy     cycle with the TKI dasatinib.      Dasatinib will be administered at the standard dose and schedule recommended by the FDA (70     mg BID). The autologous type-I DC vaccine will be administered either prior to, or     concomitant with, the initiation of dasatinib administration. All patients will receive     dasatinib at a starting dose of 70 mg twice daily by mouth in the outpatient setting     approximately every 12 hours, at the same time each day.      The DC vaccine will be administered by a single intradermal injection of approximately 10e7     cells, with all the DCs being administered on days 1 and 15 of every cycle on an outpatient     basis in the University of Pittsburgh Clinical and Translational Research Center (UPCI-CTRC).      Patients on Arm A will start dasatinib administration on cycle 2, day 1 (week 5), while those     patients in Arm B will start dasatinib administration on cycle 1, day 1 (week 1).      Men and women at least 18 years of age must be HLA-A2+ and have histologically confirmed     melanoma that is metastatic (Stage IV) or unresectable Stage IIIB/C and for which standard     curative or palliative measures do not exist or are no longer effective.   "
107712|NCT01876199|"     In this research, the investigators want to see if early detection of HIV infection can be     improved by testing young adults who seek urgent health care from pharmacies and healthcare     facilities with symptoms similar to those people get with recent HIV infection.      Specific objectives:        1. What proportion of people presenting with these symptoms are HIV positive at the point          of seeking urgent health care?        2. What proportion of those who test negative or where the result is unclear (one rapid          test positive and one negative) at first rapid HIV testing, will test positive two weeks          later?        3. What is the best way (SMS, phone call or home visit) to remind people to come for the          second test after two weeks?        4. Will young adults who seek urgent health care for fever, body pains, diarrhoea or an STD          from pharmacies or health facilities find it acceptable to be invited for an HIV-1 test          at the time of health care seeking?      Hypotheses        1. Targeted screening for AHI among patients seeking health care for symptoms compatible          with AHI or sexually transmitted disease (STD) will identify AHI cases in more than 1%          of those screened.        2. Intense follow-up of patients evaluated for AHI will improve rates of repeat HIV-1          testing 2-4 weeks after initial health-care seeking, relative to standard practice          (i.e., recommendation to return for testing on a given date).   "
107713|NCT01876186|"     To investigate whether prolonged period of treatment (6 months) can have a better therapeutic     outcome than conventional period (3 months) of antimuscarinics.   "
107847|NCT01874405|"     Iron overload is a leading cause of morbidity and mortality in transfusion-dependent     patients. Deferasirox is the most promising iron chelator agent in several clinical     scenarios. The investigators propose a retrospective study (chart review) to evaluate     comprehensive iron overload management in transfusion-dependent patients treated with     deferasirox for up to 5-10 years in a real clinical practice setting.   "
107714|NCT01876173|"     Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of     cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers     high-risk patients a treatment option to reduce the incidence of SCD by delivering an     internal shock to restore a normal rhythm, if needed. Definitive evidence has established the     effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a primary     prevention indication). Approximately 3,700 new candidates accrue annually. Practice     guidelines define the criteria to determine patient ICD candidacy for primary prevention.     However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes,     renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and     risks of an ICD can become complex, particularly when competing mortality risks are present.     Research has recognized human costs associated with device complications and shocks affecting     psychological, health related quality of life (HRQL), and morbidity outcomes. The     complexities surrounding the long-term benefits/risks, complications, replacements, and     shocks, warrant decision support to prepare patients to make decisions. In Canada, there is     no clear framework to support patients' decision-making in the context of ICD treatment     options. Decision support, using a decision aid, could moderate treatment related uncertainty     and prepare patients to make active, informed, quality decisions.      Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making     (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to     determine the feasibility of conducting a trial.   "
107715|NCT01876160|"     The sensory and motor perception thresholds can influence the therapeutic effects of     Transcutaneous Electrical Nerve Stimulation. This study aimed to determine the threshold of     sensory perception and the threshold of motor response in young and elderly subjects of both     sexes. Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal     groups of young and elderly subjects. Half of the individuals in each group were stimulated     with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on     the flexor muscle bellies of the wrist and fingers. The threshold of sensory perception was     identified as the first sensation of increased current intensity and the threshold of motor     response as the minimum muscle contraction detected. The results were submitted to ANOVA     test, followed by the Tukey test, with a significance level of 5%.   "
107716|NCT01876147|"     Vision testing is a fundamental part of every optometry and ophthalmology assessment.     Traditional vision testing charts are not able to measure vision below a certain level.     Vision in this range is classified as counting fingers (CF), hand movements (HM) and light     perception (LP). These measures are not very accurate or easily quantifiable. They are also     poorly understood in terms of impact on quality of life. This study aims to assess new     methods for measuring the vision of patients with very low vision.   "
107717|NCT01876134|"     Acute kidney injury (AKI) is a common heterogeneous disease that complicates several medical     and surgical conditions. Recent studies have demonstrated that the occurrence of AKI     significantly increase the risk of adverse outcomes. Despite the advanced in modern medicine,     the interventions for AKI are not improved. One major reason of the failure to shift     therapeutic progress is the clinicians' widespread dependence upon serum creatinine, an     unreliable marker during acute changes of renal function, for the diagnosis of AKI.      In the past decade, over 20 unique biomarkers of AKI had been explored. Among them,     neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury     molecule-1 (KIM-1) have received the most interest. None of them, however, is an idea one.      Cysteine-rich protein 61 (Cyr61), a secreted matrix-associated heparin-binding protein,     belongs to the CCN family. It regulates a broad spectrum of cellular activities, including     cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis,     and extracellular matrix production of multiple cell types. By the kidney     ischemic/reperfusion injury animal model, Cyr61 gene was found to be rapidly up-regulated in     the renal outer medulla. That portion of the kidney is corresponding to the area of     marginally oxygenated under normal condition and most tubular injury following renal     ischemic/reperfusion injury.18 Elevation of Cyr61 protein was detected in the kidney and also     in urine following injury, making it a potential marker of AKI.      Additionally, pulse diagnosis is an integrative part of traditional Chinese medicine. With     spectral analysis of the pulse waves, researchers started to observe the pulse wave     harmonics. An in vivo study of rats revealed that ligating one or both of the renal arteries     significantly reduced the second harmonic component of the pressure pulse at the caudate     artery. Ligating the artery toward the spleen prominently reduced the third harmonics     component of the pulse. Analysis of the harmonics in the spectrum of the arterial pressure     wave revealed that individual organs might have their own natural frequencies. These     observations suggested that individual vascular beds exert independent, frequency-specific,     effects on the peripheral pressure wave.      Among different etiologies, cardiac surgery is an important cause of AKI. It has been shown     that AKI after cardiac surgery is relatively highly prevalent and prognostically important.     Cardiac surgery is usually performed with the use of extracorporeal cardiopulmonary bypass     machine ('on-pump').      Based on the evidence from cell culture study and animal study in the literature, we     hypothesize that Cyr61 is rapidly increased in the urine after AKI. We thus design this     project to evaluate study the diagnostic role and clinical application of Cyr61 in AKI. We     will conduct a prospective cohort study to evaluate the changes of urinary Cyr61 in patients     undergoing cardiac surgery. Cyr61 may serve a good biomarker for the early diagnosis of     patients with AKI, either singly or in combination with NGAL. By the way, we also try to     correlate the changes in those biomarker with a potential new tool：harmonic analysis of     arterial pressure pulse waves. We have special interest in following the time course of     changes in biomarker and correlate with changes in pulse analysis. Physiological parameters     of vascular compliance and regional blood oxygen saturation will be correlated concurrently.     It is hoped that early detection of AKI will lead to earlier intervention, thus enhancing our     ability to develop beneficial therapies.   "
107718|NCT01876121|"     This study is to assess the safety and efficacy of celecoxib on the pain relief from acute     pain.   "
107719|NCT01876108|"     The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease     (NAFLD) is controversial.   "
107720|NCT01876095|"     Nursing home residents are among the frailest patient groups with a high number of     co-morbidities and a high use of medicines. Inappropriate polypharmacy (i.e. often     overprescribing) is one of the major problems in the nursing home population increasing the     number of adverse drug reactions, falls, hospital admissions, mortality as well as having an     impact on health care utilization. Multidisciplinary medication reviews have a great     potential to reduce inappropriate medication use. The purpose of this study is to determine     the efficacy of a multidisciplinary medication review model focussing on discontinuing     inappropriate medication in a cluster randomized controlled trial in 600 nursing home     residents. The primary outcome measure is the difference in proportion of residents who     successfully discontinued medication between intervention and control group after four     months. Secondary outcome measures will be the drug burden index, adverse drug withdrawal     events related to the discontinued medication, death, referral to hospitals and quality of     life.   "
107721|NCT01876082|"     Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential     local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at     diagnosis is about 30 years.      Only a complete surgical excision is recommended in desmoids tumors. Some forms of desmoid     tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical     treatment. In these clinical situations, only a medical treatment may achieve tumor control     and quality of life maintenance. Place of systemic treatments in the management of desmoids     tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is     actually the best evaluated combination, which allowed observing objective response rate     between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity.      Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type     receptors -1, -2 and -3 of VEGF receptors on the PDGFA and B, and c-Kit. It is currently     under clinical development in humans in the treatment of several tumor types.   "
107722|NCT01876069|"     Background:      Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate     diagnosis of a pancreatic mass is important to direct patient management. Endoscopic     ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling     pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some     limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To     overcome these limitations, a new needle device with ProCore reverse-bevel technology was     developed recently.      Aims:      The objective of this prospective study is to compare the rate of diagnostic sufficiency in     the EUS sampling by using newly developed ProCore needle with conventional FNA needle in     suspected unresectable pancreatic cancer. We will also compare the safety, the yield of     histologic core tissue and the cost-effectiveness between these modalities.   "
107733|NCT01875926|"     The overall aims of the study are:        -  To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i)          local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of          ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations          after intravenous administration.        -  To further determine the safety and local and systemic tolerability of ALX-0171.        -  To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of          ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).   "
107723|NCT01876056|"     While Cognitive behavior therapy for psychosis (CBTp) is now established as an effective and     evidence based therapy for psychotic illnesses in the west and is recommended by the national     organizations both in Europe and in the USA. However, CBT remains limited to the western     clients. We have adapted CBT for psychosis in Pakistan for use with local clients. Initial     evaluations have found that these therapies are effective. Due to the financial restraints we     would like to test a brief version of the Culturally adapted CBTp (CaCBTp) in Pakistan. We     want to see if brief CaCBTp (6 sessions of CBT) would be effective in non western cultures in     educing symptoms of schizophrenia. This study will test brief CaCBTp against care as usual in     Pakistan in secondary care.   "
107724|NCT01876043|"     Liposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the     basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma     / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic.     Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by     well-differentiated component associated with a contingent sarcomatous differentiation and     fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development     is very long asymptomatic. At diagnosis, tumor volume is often very important making surgical     removal impossible in a high proportion of cases. Operable tumors have also a risk of local     recurrence by about 50% and about 20% metastatic. Chemotherapy is the only treatment of these     advanced forms. However, the currently available drugs (adriamycin, ifosfamide) have only     very limited effectiveness. Progression-free survival of patients does not exceed 2 months.     The LDD is characterized cytogenetically by the constant presence of two amplicons (1p32 and     6q23) respectively targeting genes MAP3K5 and JUN. These two genes encode proteins involved     in the signaling pathway Jun N-terminal kinase (JNK). Activation of JNK is involved in the     loss of adipose differentiation and tumor aggressiveness of LDD. The plitidepsin is a drug     capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK     pathway. This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD.     plitidepsin could represent the treatment of choice for patients with advanced LDD. The     objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with     locally advanced dedifferentiated liposarcomas and / or metastatic.   "
107725|NCT01876030|"     The investigators hypothesize that the gait pattern of following the utilization of a     functional electrical stimulation device will be much improved when compared to the effect of     regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early stages     following stroke.   "
107726|NCT01876017|"     This Study is single arm, single center trial to check the safety and efficacy of Autologous     Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)for the patient with CRF   "
107727|NCT01876004|"     Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy     if the complementary use of Methotrexate could provide better results. We evaluate the     success of treatment and the time required for titers of β-hCG to become negative. Methods: A     double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients     will be divided into two groups: in one patients will be administered a single intramuscular     dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo     intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day.     When the decline of beta-hCG titers was > 15% in this interval, the patient was followed with     weekly dosing of β-hCG until the titers become negative. The criterion of success is when the     β-hCG was negative. The treatment failure occurs when surgery was necessary.   "
107728|NCT01875991|"     The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis     (PsO) patients who self inject etanercept for one of two experimental autoinjectors.   "
107729|NCT01875978|"     Phytosterols are plant sterols . Phytosterols have anti-inflammation effect. Investigators     have a hypothesis: phytosterols reduce oxidative stress , enhance Insulin-like growth     factor-1(IGF-1) and endothelial progenitor cells(EPCs). Therefore, phytosterols has novel     role in cardiovascular protection.   "
107730|NCT01875965|"     Background and Purposes: Orthognathic surgery is necessary in more than 25% of patients with     cleft lip and palate (CLP) to correct skeletal discrepancy and to obtain harmonious facial     esthetics in the final phase treatment. A setback of mandible by bilateral sagittal split     osteotomy (BSSO) along with maxillary osteotomy is usually performed when large skeletal     discrepancies or associated mandibular deformities (e.g., asymmetries, canting of the     mandibular occlusal plane) are present. Although the surgical technique of BSSO is     well-developed, the neurosensory disturbances of the inferior alveolar nerve (IAN) remain one     of the major postoperative complications. The purpose of this study is to identify the risk     factors of IAN disturbances after BSSO and in turn to help clinicians to avoid such     complication and to raise the satisfaction level of patients.      Design: Prospective prognosis study. Setting: Chang Gung Craniofacial Center, Taoyuan.     Patients: Two hundred Taiwanese patients with nonsyndromic CLP (age, >16 for females, >18 for     males), who will undergo a BSSO as a part of the correction of their dentofacial deformities     Measurements: All patients will undergo subjective (e.g., questionnaire) and objective (e.g.,     2-point discrimination, light touch detection, and sharp/blunt detection) neurosensory     assessments before surgery, and 1, 3, 6, 12 and 24 months after surgery. Cone beam computed     tomography is performed before surgery and 1 week after surgery. Peri-operative factors     including type of BSSO, extent of surgical correction, extent of split and fixation screws,     concomitant genioplasty or third molar extraction are assessed. Patient-related factors     including age, gender, bone quality of inferior alveolar canal are recorded as well.      Data Analysis: Univariate and multivariate analyses will be performed. Statistical     significance is assumed for a p value of less than 0.05.   "
107731|NCT01875952|"     The purpose of this study is to determine of once identified to the subjects infected with     human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat     her with isoniazid for six months, measuring the production of Interferon range pre and     posttreatment, to evaluate this way the result of the treatment on the immune response   "
107732|NCT01875939|"     This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and     determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to     WCK 771 800 mg (intravenous, QD dose).      This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK     2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771,     IV to WCK 2349, oral) in future clinical trials in patients.   "
107763|NCT01875536|"     Given previous evidence that non invasive brain stimulation enhances the effects of     conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to     determine if the repetitive transcranial magnetic stimulation (rTMS)combined with     conventional physical therapy (VRT) would be superior to physical therapy in improving upper     limb function and quality of life with chronic stroke individuals.   "
107734|NCT01875913|"     The investigators will work with one of Vitality's partner corporations to test whether     curiosity can motivate employees to follow through on their virtuous intentions and complete     their annual health risk assessment (VHR). Employees will receive email messages that contain     either a curiosity-inducing question or a standard encouragement message. The investigators     predict that presenting people with curiosity-arousing questions will make them more likely     to complete a health risk assessment, as compared to standard messages.   "
107735|NCT01875900|"     Simulation-based training has been widely implemented in medical education. According to     educational theories, simulation-based medical education (SBME) is associated with     significant advantages, which has been investigated and proved by many studies. However, the     value of SBME in comparison to other instructional methodologies remains largely unknown.     Therefore, the aim of this study is to directly compare two instructional methods for     neonatal resuscitation training.   "
107736|NCT01875887|"     Combined application of surgery planning software and rapid prototyping technology and     preshaped titanium plates can effectively promote the accuracy of the diagnosis and treatment     of bilateral maxillofacial post traumatic deformities, reduce operation time and improve     surgical effect.   "
107737|NCT01875874|"     This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in     subjects with acute liver failure (ALF) compared to matched historical controls.   "
107738|NCT01875861|"     The purpose of this study is to test an approach for implementing guideline recommendations     for assessing and managing metabolic side effects (including weight gain, diabetes, elevated     lipids) in patients prescribed antipsychotic medications.   "
107739|NCT01875848|"     This study compares buprenorphine/naloxone to opioid dose escalation among patients with     poorly controlled non-cancer pain on 30-100 mg daily morphine equivalent opioid dose.   "
107740|NCT01875835|"     Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion     strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is     more effective than thrombolytic regimens in reducing adverse events, including death.     Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The     effectiveness of DES to reduce restenosis and the need for revascularization compared with     bare-metal stents (BMS) has been documented in randomized controlled trials. The     first-generation DESs implanted in STEMI have been associated with delayed healing and     incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual     antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved     the drug and polymer, which have been proved to improve neointima healing compared with the     first generation DESs.      However, the difference of strut coverage between EES and BMS implanted in STEMI patients is     unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up     in EES and BMS implanted in patients with STEMI by optical coherence tomography.   "
107741|NCT01875822|"     Current evidence suggests that schizophrenia as a serious and complex psychiatric disorder,     continues to challenge mental health professionals in their search for better treatment     options in the community. In the present study, the investigators hypothesized that in     patients diagnosed as schizophrenia, adjunct treatment with Curry extract from the plant     labeled by botanists as Curcuma Longata, formulated as Super-Curcumin@ , would bring about     :1)positive behavioral changes in areas of socialization, emotional well-being, verbal     communication and motivation; 2)improvement in measures of memory. Throughout the study, the     proprietary product, Super-Curcumin@ consisting of Curcumin C-3 complex combined with the     black pepper extract Bioperine to boost the effects of Curcumin. The study was developed to     examine whether Curcumin's interaction with the two major signal pathways in the brain     regulating brain-behavior: the epigenetic signal (histone modification) and the     anti-inflammatory signal (inducible nitric oxide synthetase)in preclinical models is     translated to beneficial effects in the treatment of schizophrenia.   "
107742|NCT01875809|"     Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is     known regarding the patient or procedural characteristics influencing the outcome. None of     the detectable variables like number of ablation points, temperature rise, impedance drop,     have been shown to correlate with the blood pressure (BP) reduction. In this study, the     investigators assess different patient and procedural characteristics, like exact patient     medication, stress hormones, heart rate variability, and focus on the change of the     catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP     ablation. The investigators hypothesize the correlation between reduction of catecholamine     spill-over due to denervation and the BP reduction. In this study, the investigators will     assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.   "
107743|NCT01875796|"     This project tests the feasibility and utility of a novel, integrated approach to treatment     of patients with cannabis use disorder (CUD) and anxiety disorders.   "
107744|NCT01875783|"     The purpose of this protocol is to determine whether point of care optical coherence     tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary     diabetes care visits increases rates of retina specialist eye care for patients with diabetic     macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral     algorithm will enable identification of patients at risk for vision loss from diabetic     macular edema and facilitate direct referral to retina specialists for more timely evaluation     and treatment.   "
107745|NCT01875770|"     This research is being done to assess the long term prognosis of patients treated with     ranibizumab for edema due to retinal vein occlusion.   "
107764|NCT01875523|"     The study is designed to evaluate the pharmacokinetics, safety and tolerability,     immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with     severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.   "
107765|NCT01875510|"     Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal     development. Infants born prematurely are at special risk for DHA insufficiency. The source     of DHA after birth for preterm babies who are not fed full enterally, are mostly fat     emulsions as the component of total parenteral nutrition solutions which usually do not     contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered     from the first day of life and during parenteral nutrition-prevents infants from cholestasis     and retinopathy of prematurity.   "
107746|NCT01875757|"     A phase III multicenter randomized double blind clinical trial will be conducted. After     obtaining written consent the infant will be randomized, during the first two weeks of life,     to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.      Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric     measurements and a questionnaire about health issues. A blood sample will be obtained at     baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin     D, and calcium.      Healthy term born infants of appropriate size for gestational age will be included. We will     need to include 359 children in each group.      The primary objective of the study is to decrease the proportion of infants with acute     bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D.     Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases     the proportion of infants with upper respiratory tract infections, the proportion of children     under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare     system due to respiratory infections and absences from work for parents and achieves a higher     proportion of children with adequate blood levels 25 OH vitamin D.   "
107747|NCT01875744|"     Background:      Aim:      Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the     maintenance treatment of functional constipation in children.      Study design:      Randomized, open-label trial.      Randomized, double-blind, placebo controlled trial.   "
107748|NCT01875731|"     The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in     children with non severe community acquired pneumonia (CAP) and pneumoccocal vaccine will     reduce antibiotic use as compared to standard care practice (current guidelines for CAP).   "
107749|NCT01875718|"     The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess     the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy     women. The safety and tolerability of UC1010 is also evaluated in study part 1.      In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on     premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during     the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the     patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment     groups are compared to one placebo group.   "
107750|NCT01875705|"     This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability,     and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid     tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or     the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability,     and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather     additional data on safety, tolerability, and pharmacokinetics of the recommended dose of     GDC-0994 determined in Stage I.   "
107751|NCT01875692|"     Pathogens of ventilator-associated pneumonia (VAP) come from colonizers of the trachea. The     hypothesis of the investigators is that during the first days of intubation, independently of     the use of antibiotics, there is a change in the oro-pharyngeal flora leading to the     selection of one pathogen in the trachea, that will finally be the cause of VAP.      The investigators designed a prospective study including 300 patients intubated for more than     3 days, with daily analysis of oro-pharyngeal juice and tracheal aspirate by culture and     metagenomics, in order to determine if this microbiological surveillance permits:        1. To predict a high risk to develop a VAP in the next 48h and even to predict its agent        2. To better understand the development of VAP by studying the evolution of the          respiratory flora in the context of intubation   "
107752|NCT01875679|"     Simulation in surgical skills training is widely accepted as a necessary step to improve     surgical training outside the operating room. Simulation predominately focuses on teaching a     specific task or procedure. Once this task is acquired ongoing optimization of technique is     desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout     training rotations. This feedback is frequently subjective and of variable educational use.     Identifying ongoing technical training needs and enabling personalized objective feedback     represents an important training concept that has not yet been formally used in resident     training.      The specific goal of this study is to prove the effect of a comprehensive surgical coaching     (CSC) approach which combines concepts of behavior modeling training, task debriefing and     error recognition to improve overall surgical technique without additional technical skills     training.   "
107753|NCT01875666|"     Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind     of kinase. This study looks at a new approach to identifying kinases, which may help target     therapy more precisely.      LCCC1214 is a randomized, multiarm, multicenter, open-label window trial designed to explore     the kinome response in Stage I-IV HER2 positive (HER2+) breast cancer patients scheduled to     undergo definitive surgery (either lumpectomy, mastectomy or surgical resection of     oligometastatic disease). Patients will initiate dosing with either a single HER2-directed     agent or a combination of two HER2-directed agents, one week prior to surgery. Forty patients     will be randomized to one of four study groups:      A) single dose trastuzumab; B) single dose pertuzumab; C) combination single dose trastuzumab     plus single dose pertuzumab; or D) combination single dose trastuzumab plus lapatinib daily     for 7 days.      Pre- and post- dosing tissue will be analyzed for kinome response and resistant signatures.     The initiation of study drug will be defined by the surgical schedule; there will be no     delays in standard treatment for the purposes of this study.   "
107766|NCT01875497|"     There is evidence that intense physical activity has a potential effect on thrombotic events     due to catecholamine release. The hormones leptin and adiponectin have been used as markers     of cardiovascular risk, but they are few and contradictory studies that relate physical     training intensity and duration of high plasma concentrations of these hormones. The use of     antioxidants, such as proanthocyanidins present in grapes, may help in reducing the     undesirable effects of intense training.   "
107767|NCT01875484|"     Purpose: The purpose of this study is to evaluate the impact of circulating miR-126 on left     ventricular remodeling and clinical outcomes in patients undergoing primary percutaneous     coronary intervention for ST-segment elevation myocardial infarction.   "
107768|NCT01875471|"     The objective of this study is to compare the ease of removing two daily disposable soft     contact lenses off the eye.   "
107754|NCT01875653|"     The purpose of this research is to evaluate the safety and effectiveness of tumor cell     therapy.      This research study is evaluating if a patient-specific experimental therapy for metastatic     melanoma will lengthen survival with minimal harmful effects. It is called an experimental     therapy (or study therapy) because it is not yet approved by the U.S. Food and Drug     Administration (FDA). This research study will use the patient's own tumor cells,the     patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony     stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that     stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a     standard treatment to help increase the number of white blood cells after chemotherapy.      The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the     growth factor. The resulting solution is called the study therapy. The intent of the study     therapy is to make the dendritic cells more effective at fighting the tumor when they are     injected back into the patient.   "
107755|NCT01875640|"     The birth of a child with a disorder of sex development (DSD) is stressful for parents and     members of the healthcare team. The right decisions about gender assignment (is it a boy? a     girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are     not obvious. While there have been large advances in diagnostic assessments like genetic and     endocrine testing, the tests do not always show what caused the DSD. And, even when the tests     do reveal an explanation for the DSD, knowing what happened genetically or hormonally does     not usually lead to a single correct treatment plan. Instead, it is likely that there are     different acceptable treatment options - and parents will need to make decisions based, in     part, on their personal preferences, values, and cultural background. Adding more stress to     the situation is knowledge that many of the decisions that need to be made by parents early     in a child's life are irreversible and exert life-long consequences for the child and the     family.      To support parents becoming actively involved in making such decisions, and to reduce the     likelihood of future worry and regret about decisions that have been made, the investigators     will create a decision support tool (DST). The DST will help educate families about typical     and atypical sex development of the body, the process by which DSD are diagnosed (especially     how to interpret genetic test results), and possible relationships between diagnostic/genetic     testing, decisions about care, and known consequences of those decisions on their child and     entire family. The DST will be used by parents of young children together with their child's     health care provider.      The investigators will bring together a network of researchers, health care providers,     representatives of patient support and advocacy organizations, and parents of children with     DSD to share their experiences. Participants of this network will be involved at each stage     of creating the DST, revising it, and putting it into practice. At the end of this project,     the investigators will have a fully formed DST that will be available for parents to use with     their child's healthcare team as they are first learning their child may have a DSD.   "
107756|NCT01875627|"     To evaluate the effects of Konjac on satiety and subsequent food intake in healthy     individuals.   "
107757|NCT01875614|"     Use of dipole density mapping to identify activation in complex supraventricular tachycardias   "
107758|NCT01875601|"     BACKGROUND:        -  Despite progress, some children and young adults with solid tumors still experience poor          survival.        -  Activated NK cells potently kill autologous pediatric solid tumors, and clinical grade          procedures are available to generate large numbers of activated NK cells for adoptive          cell therapy.      OBJECTIVES:        -  Primary objectives are: 1) to assess the feasibility of harvesting and expanding          activated NK cells to meet escalating dose goals in Cohort A, 2) to assess the toxicity          of infusing escalating doses of activated NK cells following lymphodepleting          chemotherapy without rhIL15 (cohort A), and 3) to assess the toxicity of infusing NK          activated cells with escalating doses of rhIL15 (cohort B) in pediatric patients with          refractory malignant solid tumors.        -  Secondary objectives are: 1) to identify biologically active doses of activated          autologous NK cells plus or minus rhIL15 by monitoring changes in NK cell number,          phenotype and function, 2) to assess pharmacokinetics and immunogenicity of rhIL15 in a          pediatric population, and 3) assess antitumor effects and changes in FDG-PET following          administration of activated NK cells to lymphopenic hosts plus or minus rhIL15. 4) to          evaluate saftey and efficacy of subsequent cycles of autologous NK cell infusions in          patients in cohort A who received benefit from the first NK cell infusion.      ELIGIBILITY:        -  Patients in Cohort A: 2-29 years with with refractory pediatric malignant solid tumors,          Patients in Cohort B: 2-25 years with refractory pediatric malignant solid tumors.        -  Adequate performance status and organ function, recovered from toxic effects of prior          therapy, no requirement for systemic corticosteroids and no history of allogeneic stem          cell transplantation.      DESIGN:        -  All patients receive pre-NK lymphodepleting chemotherapy with cyclophosphamide.        -  Cohort A receives escalating doses of activated autologous NK cells to identify          feasibility of generating cells and tolerability, and potentially identify an MTD.        -  A1: 1x10(6) NK cells/kg        -  A2: 1 x 10(7) NK cells/kg        -  A3: 1 x 10(8) NK cells/kg        -  If feasibility and acceptable toxicity is demonstrated for all doses in Cohort A,          patients enrolled on cohort B will receive activated autologous NK cells plus escalating          doses of rhIL15 using the following schema:        -  B1: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10        -  B2: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10        -  B3: 1 x 10(7) NK cells/kg + rhIL15 0.5 mcg/kg/d IV x 10        -  B4: 1 x 10(7) NK cells/kg + rhIL15 0.75 mcg/kg/d IV x 10        -  Three patients will be enrolled at each dose level, with the dose level expanded to 6 if          dose-limiting toxicity occurs. An expanded group of 12 patients will be treated at the          highest tolerable dose level. DLT toxicity monitoring will continue for 21 days after          the NK infusion, or 14 days after the last rhIL15 dose in Cohort B (whichever is later).   "
107759|NCT01875588|"     Background:      - People with human immunodeficiency virus (HIV) can sometimes develop thinking and memory     problems. These problems can vary widely, from few symptoms to severe problems with memory     and concentration. It initially was thought that good HIV treatment could prevent almost all     HIV-related memory problems. However, even people with low HIV viral loads can have these     problems. It may be caused by HIV affecting the brain and spinal fluid. It is not yet clear     why HIV causes these problems and why they may be worse in some people than others.     Researchers want to study people with HIV and healthy volunteers to see how HIV may affect     people with only small amounts of the virus in their blood.      Objectives:      - To study thinking and memory problems in individuals with HIV that is otherwise controlled     with medications.      Eligibility:        -  Individuals between 18 and 61 years of age whose HIV has been controlled with          medications for at least 1 year.        -  Healthy volunteers between 18 and 61 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. A neurological test will also be given. Participants will          have a baseline imaging study of the brain.        -  Within 12 weeks of the first visit, participants will have a second visit. Additional          blood samples will be drawn. Another brain imaging study will be performed.        -  Within 8 weeks of the second visit, participants will have a third visit to collect more          blood samples. They will also provide spinal fluid samples, either as a single visit or          a longer procedure.        -  After this visit, participants will return every 6 months for up to 5 years. Blood          samples will be collected as needed at these visits. Thinking and memory tests and          imaging studies may also be given as needed. Spinal fluid may be collected at one visit          a year.   "
107760|NCT01875575|"     The objective of this study is to examine gastric emptying and satiety hormones after oral     glucose stimulation in 2 different concentrations in normal-weight and obese patients.   "
107761|NCT01875562|"     Neck pain is a common symptom in most patients suffering from cervical radiculopathy.     However, some conservative treatments are limited by their modest effectiveness. On the other     hand, surgical intervention for cervical disc disorders is indicated when symptoms are     refractory to conservative treatments and neurological symptoms are progressive. Many     patients use complementary and alternative medicine, including Traditional Chinese Medicine,     to address their symptoms. The purpose of the present study is to examine effectiveness and     safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in     patients with cervical radiculopathy.   "
107762|NCT01875549|"     Internal biliary drainage is an useful method for a control of jaundice and cholangitis to     patients who had a malignant hilar obstruction due to hepatocellular carcinoma,     cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.      Bilateral biliary drainage is more physiologic but technically difficult to compared with     unilateral biliary drainage specially related to conformability and flexibility between using     stents.      There are no prospective clinical trials compared with these internal biliary drainage     methods in hilar malignant obstruction using metal stent.      Therefore, the investigators want to compare the clinical outcome of two method: Unilateral     biliary stent and Bilateral biliary stent   "
107769|NCT01875458|"     Bisphosphonates are drugs that prevent bone loss by blocking the activity of cells that     normally resorb bone. The most common examples of these drugs are Boniva and Fosamax. These     drugs are available for oral or intravenous dosing and are prescribed at daily, weekly,     biweekly, or monthly intervals. Among the many thousands of individuals who currently take     these medications, certain individuals experience atypical femur fractures preceded by     prodromal pain, changes in cortical thickening of bone, or bisphosphonate related     osteonecrosis of the jaws (BRONJ). Osteonecrosis of the jaws is defined as exposed bone of     the jaws for 8 weeks or more and requires surgical treatment.      This study will attempt to identify genomic and rna biomarkers that may play a role in     differential metabolism of bisphosphonates or indicate tendency toward the severe adverse     events associated with these drugs.   "
107770|NCT01875445|"     The purpose of this study is to evaluate the safety and effectiveness of inositol for the     treatment of compulsive hair pulling, also known as trichotillomania. Inositol is used for     diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression,     schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism,     promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical     treatment with some medications, including lithium. The hypothesis to be tested is that     Inositol will be effective and well tolerated in patients with trichotillomania compared to     placebo. The proposed study will provide needed data on the treatment of the disabling     disorder that currently lacks a clearly effective treatment.   "
107771|NCT01875419|"     Depression is a serious mental health problem that affects millions. Depression is usually     treated using drugs and/or psychotherapy, but neither approach is successful for everyone,     and some people do not respond to either. Therefore it is crucial that we continue to seek     new methods for treating depression, and develop enhancements to existing treatments. In     recent years, trials have documented improvements in depressive symptoms using noninvasive     brain stimulation techniques, such as transcranial direct current stimulation, or tDCS. Our     aim in this research is to investigate the effects of brain stimulation combined with     psychological therapy in depression, an area that remains largely unexplored. Specifically,     stimulation of the dorsolateral prefrontal cortex (DLPFC), a brain region known to work     inefficiently in depression, has been shown to result in an improvement of depressive     symptoms, as well as in the patient's 'cognitive control' abilities. Because 'cognitive     control' processes, such as concentrating and ignoring distracting thoughts, are engaged     during psychological therapies for depression, we predict that DLPFC stimulation should     improve how patients respond to psychological therapy. This study has considerable     implications as it will potentially benefit a large number of patients for which current     treatments are ineffective.   "
107772|NCT01875406|"     The purpose of this study is to determine the predictive value of a composite of 3 simple     clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined     with a pain referral diagram in predicting response to a single diagnostic SIJ injection.   "
107773|NCT01875393|"     The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after     TOOKAD® Soluble VTP in localized prostate cancer patients.   "
107774|NCT01875380|"     The purpose of this study is to assess the efficacy and safety of single-agent regorafenib in     the first line treatment of frail and/or unfit for polychemotherapy patients with metastatic     colorectal cancer (mCRC)   "
107775|NCT01875367|"     GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national     designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of     trastuzumab, and within the SC by the administration through the vial or device     self-administration in patients with disseminated breast cancer HER2.      Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose     of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a     syringe and 2 with the injection device). Following administration of these four cycles, the     patient will decide whether or not to continue with the subcutaneous formulation of     trastuzumab every 3 weeks until progression. Since the randomization in the study until the     start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous     trastuzumab as usual.      Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs     intravenous trastuzumab.      This principal primary objective will be analyzed with the answers to questionnaire of     experiences and preferences of the patients (Principal endpoint) The duration of the study     has been estimated after 34 months.   "
107776|NCT01875354|"     The purpose of this study is to assess the safety and efficacy of a weight management program     composed of dietary supplements and a reduced calorie eating program.   "
107777|NCT01875341|"     Hypertension is highly prevalent in type 2 diabetic patients (NIDDM) with nephropathy, and is     the single most important determinant of the rate of renal function loss. In many of these     patients, hypertension is resistant to therapy. Although increased sympathetic activity is     also highly prevalent in NIDDM patients with nephropathy and chronic renal insufficiency,     little attention has been paid to sleep apnea as the cause of both resistant hypertension and     sympathetic hyperactivity in this population. Since the prevalence of sleep apnea is     increased in patients with either NIDDM, or resistant hypertension, or chronic renal     insufficiency, it is almost certain that sleep apnea has a high prevalence in patients in     whom all three states co-exist, i.e. NIDDM patients with nephropathy and hypertension     resistant to therapy. As a consequence of undetected and untreated sleep apnea, resistant     hypertension, nocturnal hypertension, and sympathetic hyperactivity likely contribute to     accelerated loss of renal function and increased cardiovascular morbidity and mortality in     these patients.      Hypothesis: A. Sleep apnea is highly prevalent in type 2 diabetic patients with diabetic     nephropathy and hypertension resistant to therapy. Treatment with nasal continuous positive     airway pressure (NCPAP) will result in a decrease in blood pressure and restore normal     diurnal blood pressure pattern.      B. Sleep apnea-caused hypertension is mediated by sympathetic hyperactivity and increased     activity of the renin-angiotensin-aldosterone system (RAAS) in type 2 diabetic patients with     nephropathy. A decrease in sympathetic hyperactivity in response to NCPAP therapy will result     in a decrease in plasma renin activity and plasma aldosterone concomitant with decreases in     blood pressure.      Randomized, double blind, parallel comparative (two groups) one center trial.      Therapeutic treatment with nasal continuous positive airway pressure (NCPAP) Sub-therapeutic     treatment with nasal continuous positive airway pressure   "
107789|NCT01875172|"     The purpose of this study is to determine whether bupropion SR increases cessation and/or     smoking reduction among pregnant smokers.   "
107790|NCT01875159|"     The purpose of this pilot study is to document the extent to which intermittent hypoxia     persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect     of caffeine treatment on the number of intermittent hypoxia episodes and the total number of     seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.   "
107870|NCT01874106|"     The purpose of this study is to evaluate the effect of especial diet therapy     Anti-inflammatory Diet on inflammatory, oxidative stress, and nutritional markers in the     context of protein-energy wasting syndrome(PEW) in hemodialysis patients.   "
107778|NCT01875328|"     This study aims to determine whether patients who have had a stroke caused by a blockage of     blood flow to the brain can have medical follow up after they leave the hospital in their     home using a camera connected to a computer, also called telemedicine. Patients who have     follow-up with telemedicine will be compared with patients following up in the usual way, by     coming to clinic, and will have the same expectations for medical care and lifestyle changes     like quitting smoking, exercising, and controlling their cholesterol. The study will try to     show those stroke patients who live 75 miles or more from Oregon Health & Science University     (OHSU) and use a computer for follow up: 1) Will be able to complete the recommended visits     using telemedicine in the home as well as those who come to clinic; 2) Will have blood     pressures controlled at one year's time as well as those who follow up in the usual way by     coming into clinic; 3) The patients followed with telemedicine will be as satisfied with the     type of follow up they had as those followed in the usual way in the clinic. In the future,     more patients who live at a distance from a major hospital might be able to get quality     stroke care follow up using telemedicine if the study finds that telemedicine does meet these     goals.   "
107779|NCT01875315|"     The primary objective of this project is to demonstrate that a new approach to cardiac stress     imaging that combines treadmill exercise with cardiac magnetic resonance (CMR) provides     valuable clinical information in a cost-effective manner.   "
107780|NCT01875302|"     This protocol defines the requirements to demonstrate that the PRO instruments which were     designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported     outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All     validation studies of the questionnaires were conducted using the original paper versions.   "
107781|NCT01875289|"     Efficacy of a modified obturator nerve block technique by using only a single morphological     landmark, a double-blinded randomised pilot study.   "
107782|NCT01875276|"     The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to     answer the following research questions        1. What is the first prescription of the hay-fever season and how many of these patients          are on some form of combination therapy?        2. To what extent does initial therapy not meet clinical need (as measured by need for          additional medical intervention in terms of consultations and changes in therapy)?        3. Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs          perennial patients?   "
107783|NCT01875263|"     Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related     bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical     and microbiological criteria.   "
107784|NCT01875250|"     Background:      - Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate     cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible     way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating     therapy) that may help activate the immune system against the cancer. The immune stimulating     vaccine will help white blood cells recognize and kill the cancer cells throughout the body.     This vaccine therapy has been tested in hundreds of patients and is very well tolerated.     Researchers want to see whether this vaccine, given with enzalutamide, is more effective at     treating advanced prostate cancer than enzalutamide alone.      Objectives:      - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy     for advanced prostate cancer.      Key Eligibility:        -  Men at least 18 years of age who have advanced castration sensitive prostate cancer.        -  Patients must have testosterone within the normal range        -  No evidence of metastatic prostate cancer on CT or Bone scan        -  No history of autoimmune diseases        -  No previous immunotherpy within 3 years      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies will be used to monitor the cancer before          treatment.        -  Participants will be separated into two groups. One group will have enzalutamide and the          study vaccine. The other group will have enzalutamide alone.        -  All participants will take enzalutamide once a day. They will take the drug for 3          months. This form of intermittent therapy is common in this population of patients.        -  The vaccine group of participants will receive the new study vaccine. They will have a          single injection on the first day of the first study cycle. There will be regular          booster injections afterward. There will be one injection during the third week of          treatment, and one in the fifth week. The vaccine will then be given every 4 weeks until          21 weeks have passed.        -  Treatment will be monitored with frequent blood tests and imaging studies.   "
107785|NCT01875237|"     The goal of this clinical research study is to learn if giving genetically changed immune     cells, called T-cells, after chemotherapy will improve the response to a stem cell     transplant. The safety of this treatment will also be studied.      The process of changing the DNA (the genetic material in cells) of these T-cells is called     gene transfer. Researchers want to learn if these genetically-changed T-cells are effective     in attacking cancer cells in patients with leukemia, MDS, lymphoma, Hodgkin disease, or MM,     after they have received an allogeneic stem cell transplant.      The chemotherapy you will be given on study is fludarabine, melphalan, and alemtuzumab. These     drugs are designed to stop the growth of cancer cells, which may cause the cancer cells to     die. This chemotherapy is also designed to block your body's ability to reject the donor's     stem cells.      Researchers also want to learn if giving AP1903 will help the symptoms of graft-versus-host     disease (GvHD) that may occur after the T-cell infusion. GvHD occurs when donor cells attack     the cells of the person receiving the stem cell transplant.   "
107786|NCT01875224|"     This study is being conducted to determine if belatacept is an appropriate alternative     immunosuppressive medication (reducing the immune system's effect) when a kidney transplant     patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with     NODAT will be approached with the opportunity to participate in this study. If they agree to     participate, they will be randomized one-to-one (like a coin flip) to the study arm     (belatacept) or the control arm (their current medication regimen). If a patient is     randomized to the study arm, they will be tapered off of their current regimen when they have     started receiving their monthly belatacept infusions. The control arm will mean the patient     will continue their current, standard of care medications, but following the tacrolimus     trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting     blood glucose) will be measured during the study to monitor the progression of NODAT in all     patients.   "
107787|NCT01875198|"     When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is     usually performed not only for margin-negative resection but also for effective clearance of     the splenic hilar lymph nodes. However, there was no scientific evidence regarding the     justifiability for spleen resection. Considering potential immunological function of the     spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for     left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in     terms of short-term perioperative outcomes and disease-specific overall survival.   "
107788|NCT01875185|"     The investigators are attempting to determine if the response to aspirin in women is related     to the level of estrogen and progesterone that a woman has.   "
107791|NCT01875146|"     Investigation of the training effects following 8 weeks of high-intensity interval training     (HIT)in combination with side-alternating whole-body vibration compared to conventional HIT     or side-alternating whole-body vibration. The adaptations are investigated on a molecular     (muscle biopsy of the M. vastus lateralis) and systemic (e.g. cycling, jumping mechanography,     dynamometry) level. In addition, the acute effects of the first and last training session     will be investigated on a molecular (e.g. satellite cell activation, mRNA abundance) and     systemic (e.g. ventilatory ga exchange, heart rate, rating of perceived exertion) level.   "
107792|NCT01875133|"     The purpose of this study is to investigate the effect of a stay at moderate altitude on     exercise performance of patients with chronic obstructive lung disease.   "
107793|NCT01875120|"     This prospective observational study aims to evaluate the influence of somatic symptom load     and anxiety sensitivity as risk factors for the occurrence of postoperative nausea and     vomiting (PONV). Physiological and psychological variables are assessed in female patients     with an increased risk for PONV prior to a planned surgical intervention with a 33-item     questionnaire composed of the ASI-3 and the PHQ-15. Postoperative evaluation includes the     occurrence of nausea and vomiting in the first 24 hours after surgery. It is hypothesized     that patients with high sum scores for somatic symptom load (measured with the Patient Health     Questionnaire, PHQ-15) and with increased levels for anxiety sensitivity (measured with the     Anxiety Sensitivity Index, ASI-3) experience more frequently postoperative nausea and     vomiting (PONV) than patients with low scores in both self-rating instruments.   "
107794|NCT01875107|"     Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on     weight, given to pregnant patients with gestational or preexisting diabetes receiving     betamethasone can provide adequate glycemic control.      Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help     maintain euglycemia for pregnant patients with gestational and preexisting diabetes after     steroid administration, and possibly impact length of hospital admission.   "
107795|NCT01875094|"     This is a feasibility study of using health-IT to promote self-management of risk factors in     stroke survivors.   "
107796|NCT01875081|"     If the participant voluntarily agrees to participate in the clinical trial before     registration, the investigator conducts a screening test to evaluate the participant's     suitability.      A participant that satisfies all selection and exclusion criteria is assigned randomly to a     test group (1-time or 2-time injection group) or control group (no-cell therapy group).     Participants assigned to the 1-time injection group conduct cell therapy within 1 month after     bone marrow aspiration. Before implementing cell therapy, implement hepatic artery     catheterization which inserts a catheter into the hepatic artery through the right aorta     femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells.     Participants assigned to the 2-time injection group store 1-time injection amount of     mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will     re-inject autologous mesenchymal stem cells within 1 month after first injection.      Participants will make a total of 8 hospital visits on a 4-week interval after registration,     and effectiveness and safety will be evaluated based on a fixed procedure on every visit.   "
107797|NCT01875068|"     The investigators have previously demonstrated utilizing a validated tool, that the quality     of referrals from nurse practitioners (NP) and physician assistants (PA) is less than     referrals from physicians. The investigators hypothesize that with local physician input, the     quality of referrals from nurse practitioners and physician assistants will improve. This is     a prospective study comparing patient referrals from nurse practitioners and physician     assistants with and without prior discussion with a local physician.   "
107798|NCT01875055|"     STUDY OBJECTIVES: The main objective of this study is to determine the feasibility of     implementing measures in the ICU, based on a physiological algorithm, to reverse decreases in     cerebral oxygen saturation using, near infrared-reflected spectroscopy (NIRS).      WHAT IS INVOLVED: Randomization of 50 patients is balanced by experimental group; control and     intervention, with an allocation sequence based on a block size of ten, generated with a     computer random number generator. In the INTERVENTION group ICU Staff will use NIRS to follow     a physiologically guided strategy to maintain rSO2 within 90% of baseline values. In the     CONTROL group ICU Staff will provide standard of care without the use of NIRS.   "
107799|NCT01875042|"     The proposed study is a multi-center, randomized, double blind (patient and assessor), sham     controlled clinical trial using a parallel 2 group design recruiting 220 patients of at least     18 years of age. The investigators will include patients presenting with clinically and     radiologically diagnosed knee OA according to the criteria of the American College of     Rheumatology, who experienced knee pain lasting for at least six months, and were diagnosed     with radiographic severity of ≥ 2 on the Kellgren-Lawrence grading system or had one or more     of the following signs and symptoms in the knee; restricted range of motion, pain in motion,     crepitations, morning stiffness. Patients will be randomly allocated to receive TENS or sham     TENS for 3 weeks.   "
107800|NCT01875029|"     Back School (BS) is a behavioural intervention designed to treat and prevent chronic low back     pain. Up to date clinical research studies have shown that transcranial direct current     stimulation (tDCS) is able to decrease the intensity and duration of pain modulating the     activity of brain areas involved in the circuits that regulate pain and facilitating the     mechanisms inhibitors descendants of pain control.      The aim of this study is to test the feasibility of combining tDCS with a behavioural     intervention (i.e. BS) in subjects with chronic low back pain.   "
107801|NCT01875016|"     The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT     obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.      The investigators hypothesize that the investigators will be able to reduce > 50% of the     initial LVOT gradient. This will be considered as a successful procedure.   "
107843|NCT01874457|"     On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a     mumps seroconversion much lower (71%) than the expected 95%, according to the package insert.     This could indicate that a substantial proportion of children was not protected after MMR     dose.   "
107844|NCT01874444|"     The purpose of this study is to determine whether rTMS are effective in the treatment of     tinnitus   "
138899|NCT01466647|"     This is a open single-center, explorative, Phase I pilot dose finding study including     patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and     carboplatin.   "
107802|NCT01875003|"     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will     evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants     with asthma whose disease remains uncontrolled despite daily treatment with inhaled     corticosteroids (ICS) therapy and at least one second controller medication. Participants     will be randomized in a 1:1:1 ratio to receive double-blind treatment with either     lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks     (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by     an optional 52-week double-blind active-treatment extension. The anticipated time on study     treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue     prematurely or decide not to take part in the optional active-treatment extension will     transition to the 20-week safety follow-up period.   "
107803|NCT01874990|"     Cardiovascular diseases are the principal cause of death in women in developed and developing     countries and are importantly promoted by hypertension. Salt sensitivity of the blood     pressure is considered as an important cardiovascular risk factor at any blood pressure     level. Severe preeclampsia is a hypertensive disorder of the pregnancy that also arises as a     risk factor for cardiovascular and renal diseases.      The major aim of this study is to examine the salt sensitivity of the ambulatory blood     pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with     women with no history of pregnancy-related hypertensive complications. We plan to recruit 20     non-menopausal women with a history of severe preeclampsia, and 20 age, parity, race- matched     premenopausal women as controls. The study has a case control randomized design. The salt     sensitivity of the ambulatory blood pressure is defined as an increase of ≥4 mmHg in 24h     ambulatory blood pressure on a high sodium diet. The high sodium diet is obtained by adding     capsules of 6gr of NaCl/ day in the usual diet.      The participants are identified as women discharged from the Maternity of University Hospital     of Geneva between 1999 and 2001 with a preeclampsia coding. Fetal and maternal data will be     carefully recovered from hospital records to identify severe preeclampsia (PE), based on     International Society for the Study of Hypertension in Pregnancy criteria. These criteria are     systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with severe     proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease     developing after 20 weeks of gestation in previously normotensive women. Severe preeclampsia     was also defined as occurring before 34wk of gestation. Women with a history of hypertension,     diabetes mellitus, renal or cardiac impairment, polycystic ovary syndrome will be excluded.     Other exclusion criteria are anti-inflammatory drugs, diuretics, aspirin, oral contraceptives     and hormonal replacement therapy. The protocol is approved by the University Hospital Ethical     Committee and written informed consent will be obtained from each individual in accordance     with the declaration of Helsinki. The study is conducted between 2009 and 2012 at the     University Hospitals of Geneva, Switzerland.   "
107804|NCT01874977|"     The major goal of this project is to conduct a randomized, controlled trial of the impact of     a practical, low cost physical activity intervention on fatigue among persons with rheumatoid     arthritis (RA). Fatigue has been identified as a major concern for individuals with RA, and     is considered a core outcome measure for RA. Our recent study of the sources of fatigue     identified physical inactivity as a primary predictor of fatigue. Studies have examined the     impact of exercise interventions on RA outcomes, but most of these interventions have focused     on pain or function as outcomes. The few exercise studies examining fatigue suggest that     increasing physical activity reduces fatigue, but the interventions have been     resource-intensive, requiring specially trained personnel to administer them, highly     structured activities, and/or attendance at classes or a specified facility. Each of these     components increases the cost and barriers to implementation of an intervention. Pedometers     have been shown to be an effective means of increasing physical activity, and could form the     basis of a simple means to increase physical activity.      This project will test the effect of a simple pedometer-based intervention, with two     incremental degrees of guidance, on increasing physical activity and decreasing fatigue.     Three groups (n=40 in each) will be studied: a control group with an educational pamphlet     only, a pedometer-only intervention group, and a pedometer group with step targets. Both     intervention groups will keep step-count diaries. Groups will be followed over 20 weeks. We     expect that (1) the pedometer-only intervention group will increase activity more than the     education group, and the group with step-count targets will demonstrate even greater     increases in activity; and (2) greater increases in activity will be associated with greater     decreases in fatigue. Secondary outcome measures will include depressive symptoms,     self-reported sleep quality, and body composition. Our overall goal is to demonstrate an     effective, yet simple and low cost, physical activity intervention to decrease fatigue that     could be broadly accessible and have the potential for wide implementation.   "
107805|NCT01874964|"     Methadone maintenance treatment (MMT) has been shown to be effective in reducing drug use,     criminal activity and recidivism. Given this effectiveness, maintaining individuals who are     enrolled in community MMT when committed to the Department of Corrections for short term     incarceration would improve post release outcomes. However, this is rarely practiced in the     United States. Current practice at the Rhode Island Department of Corrections is to detox     inmates on methadone within 30 days of being incarcerated. More than 75% of these individuals     are incarcerated for less than six months. The period immediately after release from     incarceration is a particularly high-risk time for HIV and other problems including drug     relapse and overdose.      The investigators hypothesize that inmates who are incarcerated for 6 months or less will     have better outcomes and cost the state less money if they are maintained on their methadone     dose and relinked to their community clinic at release, than the current practice of     detoxification.   "
107806|NCT01874951|"     The purpose of this pilot study is to determine if taking a low dose of naltrexone in     addition to an antidepressant medication can help treat relapse or recurrence in people with     Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved     naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has not     approved naltrexone to treat depression. The investigators hypothesize that patients with     breakthrough depression on an antidepressant regimen containing a pro-dopaminergic agent     assigned to treatment with low dose naltrexone will demonstrate higher rates of response     compared to those patients taking placebo.   "
107807|NCT01874938|"     The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants     with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.   "
107808|NCT01874912|"     Irisin has been identified as a novel myokine that drives brown-fat-like conversion of white     adipose tissue. In this cross-sectional study, the researches investigated whether serum     irisin levels are decreased in patients with sarcopenia compared with control subjects with     normal muscle mass, and assessed the association between serum irisin levels and various     metabolic parameters.   "
107809|NCT01874899|"     The main purpose of this study is to establish the extent that chronic pain patients     implanted with surgical, laminectomy-type, leads experience position-related variation in     spinal cord stimulation therapy and to investigate the effects of manual versus automatic     position-adaptive spinal cord stimulation on clinical outcome.   "
107845|NCT01874431|"     To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it is     safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy.     These treatment doses will be compared to placebo.   "
107846|NCT01874418|"     The purpose of our study is to investigate CSF and blood biomarkers among the subjects with     mild cognitive impairment (MCI) and Alzheimer's disease (AD) as well as normal controls.   "
107871|NCT01874093|"     The primary objective of the study is to assess the safety and effectiveness of SPG     stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in     the anterior circulation, who received IV-rtPA and Standard of Care.   "
107810|NCT01874886|"     Marijuana (Cannabis sativa) is the most widely used illicit drug worldwide, with 17.4 million     Americans reporting past month use in 2010 and 4.6 million meeting criteria for dependence,     underscoring the public health importance of understanding the biological implications of     use. How heavy cannabis use affects brain structure and cognitive performance in late life is     unknown. The ongoing maturation in the adolescent brain, including the developmental     circuitry underlying memory performance and executive control puts the adolescent brain at     high risk for detrimental effects of heavy cannabis use. With the aging of the 'baby boomer'     generation, many people who used cannabis heavily as adolescents are now entering their     senior years when age-related cognitive decline may begin. Cannabis use doubled in less than     a decade during the 1970's when 38% of those surveyed in the U.S. Survey on Drug Abuse     reported using cannabis and 12% of those users reported using cannabis more than 20 times a     month. Understanding how heavy, early cannabis use may affect neurobiological and cognitive     outcomes is of high importance for this aging population, which is already at risk for memory     and cognitive deficits in aging. Because cannabis use appears to have a primary effect within     the hippocampus, the main structure for memory and the structure affected most by age-related     memory impairments and pre-clinical Alzheimer's disease, we expect that the effects of     chronic cannabis use may be greatest during aging. To our knowledge, no study has     investigated the long-term effects of adolescent cannabis use on hippocampal morphology and     cognitive performance in an aging population.      Investigators will investigate hippocampal integrity and cognitive performance using     high-resolution magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and     neuropsychological testing in an aging population of subjects (55-70 years old) who used     cannabis more than 20 times a month for at least a year during adolescence. Investigators     will compare data collected from heavy cannabis users to subjects who did not use cannabis     but are matched for age, gender, education, light tobacco and light alcohol use. Finally,     because family history and genetic risk are known to accelerate hippocampal morphology and     memory decline in aging, the investigators will investigate whether possession of the APOE ε4     variant in heavy cannabis users is synergistically related to thinner hippocampal cortex and     white matter deficits.   "
107811|NCT01874873|"     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,     Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for     VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to explore     ALTN for the effectiveness of advanced medullary thyroid carcinoma and security.   "
107812|NCT01874860|"     The purpose of this study is to determine if using preventive treatments such as Doxycycline     (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer     will help to reduce the incidence and severity of the skin rash associated with Cetuximab     (Erbitux®) when compared to receiving standard care for the treatment of skin rash.   "
107813|NCT01874847|"     PURPOSE: The long-term goal of this line of research is to develop rational, biologically     based evidence for the treatment of post-concussion syndrome (PCS) in children. The objective     of this application is to examine the effect of melatonin on the symptoms of PCS and its     neurobiology using integrated neurodiagnostic techniques in children.      OVERVIEW: PCS is a constellation of clinical symptoms including physical (i.e. headaches),     cognitive (i.e. memory), and behavioral disturbances. PCS is associated with significant     morbidity in the child and his/her family), and yet there are no evidence-based medical     treatments available. This suggests an urgent need to develop novel treatment options to     improve outcomes for children suffering from PCS. Melatonin has several relevant mechanisms     of action, and neuroprotective effects. Recent research suggests that the explanations for     persistent PCS symptoms may be due to alterations in neurotransmissions and neuronal     circuitry, particularly involving the dorsolateral prefrontal cortex (DLPFC). Investigators     have two specific aims:        1. To determine if treatment with melatonin improves PCS in children following mild          traumatic brain injury. Hypothesis: treatment of mTBI children with PCS with 3mg or 10mg          of oral melatonin for 28 days will result in a decrease in PCS symptoms as compared with          placebo. Effects will be dose-dependent and may be independent of sleep effects.          Methods: A randomized double blind, placebo controlled trial (RCT); Outcome measure is a          PCS symptom questionnaire. A subsequent RCT will then be performed using the optimal          melatonin dose at a second centre.        2. To understand the neurophysiological mechanisms of paediatric PCS and assess any          resultant effects of treatment with melatonin. Methods: A case-controlled study within          the RCT, using functional MRI and Transcranial Magnetic Stimulation to investigate the          neurophysiological properties of paediatric mTBI before and after treatment; Treatment          groups from the RCT will be compared with two control groups: i) normal controls and ii)          asymptomatic mTBI children.      SIGNIFICANCE: This study has the potential to 1) provide a safe and effective treatment for     PCS and 2) will provide valuable information about the neurophysiological properties of the     brain associated with PCS following mTBI in children and how these change with symptom     resolution.   "
107814|NCT01874834|"     The US EPA Clean Air Multiyear research program is moving toward a multi-pollutant approach     to the assessment of air pollution in response to recommendations by the NRC 2004 and the     BOSC in 2005. Such an approach better reflects the complexity of real-world air pollution     problems and parallels evolving scientific and regulatory considerations. Ozone (O3) and     diesel exhaust (DE) generally are major and important components of ambient air pollution.     This proposed study will address the agency's goals by investigating the cardiopulmonary     health effects in healthy human subjects co-exposed to O3 and DE. The findings derived from     these exposures will provide NCEA findings for risk assessments of O3 and DE, as well as the     Office of Air and Radiation (includes OTAQ and OAQPS) with information relevant to possible     modulation of PM-induced health effects and responses by a gaseous co-pollutant for potential     standard setting. Additionally the findings will address the fundamental driving principle of     the Clean Air Research strategy related to reduction of health due to air pollutant     exposures.   "
107815|NCT01874821|"     The purpose of this study is to examine the efficacy of dynamic splinting in reducing     contracture following diagnosis of adhesive capsulitis.   "
107816|NCT01874808|"     This research program will focus on gait initiation and postural control in Amyotrophic     Lateral Sclerosis (ALS) patients, by comparing patients with vs without postural instability     (but also in comparison to controls), by using a multidisciplinary approach which combines     neurophysiological and neuroimaging analyses.      After clinical evaluation, two groups of ALS patients, defined upon the feature of postural     instability, and one group of healthy subjects (n=25 for each group of patients and 20 for     healthy subjects) will be included in the study.      The neurophysiological evaluation will be performed through a gait initiation assessment,     which will alow us to collect biomechanical and electromyographical data, such as the braking     index.      The neuroradiological evaluation will include first an fMRI analysis, a study of specific     circuits in networks will be performed which will provide the first description of neural     network dynamics associated with the preparation and execution of movement in ALS patients.      The investigators major research hypothesis is:        -  By comparing patients with vs without postural instability, but also in comparison to          controls, the investigators main research neurophysiological hypothesis is that patients          with postural instability will display an impaired braking.        -  This impaired braking could be partly explained by a dysfunction and/or lesion of the          basal ganglia and brain stem structures, corresponding to the investigators main          neuroradiological hypothesis.   "
107817|NCT01874795|"     This study will evaluate the applications of ganglionar electrical stimulation in patients     with Chagas Disease and Ischemic Heart Failure patients.   "
107872|NCT01874080|"     The purpose of this study is to determine if tablets manufactured at different sites have the     same bioavailability, that is yield similar blood levels/concentrations of the drugs and are     handled by the body similarly   "
107818|NCT01874782|"     Individuals with acute cervical spinal cord injury (SCI) can suffer from an excessive and     prolonged fall in blood pressure when assuming an upright position, such as transitioning     from lying to sitting or standing, a condition also known as orthostatic hypotension (OH).     Due to a decrease in cerebral oxygenation, affected individuals can develop debilitating     symptoms including lightheadedness, blurred vision, fatigue and even loss of consciousness.     Recent evidence suggests that OH has a negative impact on cognition in individuals with SCI.     Clinical observations suggest that OH can lead to neurological deterioration in individuals     who may otherwise have a stable SCI. The presence of symptomatic OH prevented participation     in 43% of physical therapy treatment sessions in a study of individuals with acute SCI     despite the use of current treatment options. OH is known to adversely affect health, delay     rehabilitation and prolong hospitalization in the acute phase of management of individuals     who display it. Our team found OH was present in 41 of 55 (75%) patients with acute cervical     SCI at our center in 2004.      We plan to research the efficacy of a low-cost, non-invasive device known as transcranial     electrical stimulation (TES) to manage OH in individuals with acute cervical SCI. Previous     studies have shown that this device is safe to use in individuals with SCI, and has improved     blood pressure control in non-SCI individuals.      We hypothesize that in individuals with acute cervical SCI and OH, TES intervention will     elicit an attenuation of the drop in systolic BP (SBP)in response to orthostatic stress.     TES-induced differences will be most pronounced in those individuals with sparing of spinal     autonomic pathways   "
107819|NCT01874769|"     Recessive Dystrophic Epidermolysis Bullosa (RDEB) is one of the most severe rare inherited     skin disorders affecting children and adults. Current medical care protocols for RDEB     patients are limited to palliative procedures to treat blistering and erosive lesions,     wounds, and severe local and systemic complications such as fusion and contracture of the     digits, skin cancer, esophageal stricture, severe anemia, infections, malnutrition and growth     retardation. However, current medical treatments still cannot prevent the recurrence of the     lesions arising from defective expression of type VII collagen (COL7A1), the main constituent     of anchoring fibrils which form essential structures for dermal-epidermal adherence.      The purpose of this study is to investigate the capacity of keratinocytes and fibroblasts to     repair skin wounds in patients suffering from Recessive Dystrophic Epidermolysis Bullosa     (RDEB).   "
107820|NCT01874756|"     The primary objectives of this application are to determine if the selective ERβ agonist     LY500307, when added to antipsychotic medications, improves negative and/or cognitive     symptoms in patients with schizophrenia. The specific hypotheses to be tested are to     determine if LY500307 is safe and well tolerated in this population and whether it elicits a     sufficient efficacy signal to be advanced for further testing in schizophrenia. A two-stage     Phase 1b/Phase 2a adaptive (drop the inferior dose) experimental design is ongoing that     combines three studies (clinical dose optimization, cortical target engagement confirmation     and efficacy and safety assessment) into a single clinical trial.      Stage 1 was conducted in year 1 and Stage 2 will be conducted in years 2 and 3. The goal of     Stage 1 was to identify and advance the highest dose that did not demonstrate a safety signal     and had target selectivity as determined by lack of TT suppression. This criteria was     fulfilled at both doses, the larger of the two (75 mg/day dose) was advanced to Stage 2.     Furthermore, there was no suggestion of ERα receptor activation (i.e., no pattern of TT     decreases or feminization AEs) at either dose (25 mg/day and 75 mg/day). A third arm of 150     mg/day was added to Stage 2 for evaluation. Stage 2 results in the following three arms:     placebo, 75 mg/day and 150 mg/day. The goals of Stage 2 are to further assess LY500307 doses     for safety and target selectivity, confirm cortical target engagement and assess efficacy.      Primary Aim 1: To determine if LY500307 demonstrates cortical target engagement as assessed     by fMRI/N-back in frontal-parietal regions. Secondary measures of target engagement are fMRI     episodic memory, Pseudo-Continuous Arterial Spin Labeling, Mismatch Negativity/evoked     response potentials, Auditory Steady State Response, Auditory P300 and Quantitative EEG     (QEEG).      Primary Aim 2: To determine if LY500307 is superior to placebo for one or more of the primary     efficacy endpoints: negative symptoms (Negative Symptom Assessment Scale - 16-item total     score), working memory (the composite score for the Letter Number Sequencing and Spatial Span     tests) and verbal memory (Hopkins Verbal Learning Test).      Primary Aim 3: To determine if LY500307 reduces total testosterone (TT) plasma     concentrations, which is indicative of loss of selectivity for ERβ and engagement of ERα,     using the following criteria: Decrease in TT plasma concentrations of 50% from baseline in     50% of subjects per arm treated for two consecutive post-randomization values with LY500307     in Stage 1 and Stage 2 of the trial.      Primary Aim 4: To assess the safety of LY500307 by determining if there are SAEs, AEs     probably related to study drug, QTc prolongation, TT suppression (50% reduction from     baseline) and to evaluate for other safety signals.      Secondary aims are to assess LY500307 effects on regional brain activation and connectivity     during working (2-Back visual-verbal working memory task) and episodic (scene encoding and     recognition)and memory tasks, and to evaluate electrophysiological indices of auditory     sensory processing and working memory (auditory steady state responses, mismatch negativity     (MMN) and auditory P300). It is predicted that LY500307 will produce greater increases than     placebo in brain activity in prefrontal cortex and hippocampus during the working memory and     episodic memory tasks, respectively, connectivity during resting fMRI, as well as increases     in power of the auditory steady state response, MMN amplitude and P300 amplitude. The fMRI     and electrophysiological measures will provide evidence of target engagement of LY500307 in     schizophrenia and will be assessed as potential biomarkers for future clinical trials.     Additional secondary aims will include assessing the effects of LY500307 on safety, positive     symptoms, depression, social functioning and quality of life.   "
107821|NCT01874743|"     Participating countries: France Objectives Principal objective To evaluate, in HIV-1 infected     patients receiving effective antiretroviral therapy, the effect of the addition of     Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the     proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR     Secondary objectives To evaluate the effect of Rosuvastatin administration on residual CD4     and CD8 T cell activation To evaluate the effect of Rosuvastatin administration on the main     serum soluble biomarkers of activation (CRP- HS, D-dimers, IL-6 and soluble CD14) To evaluate     the effect of Rosuvastatin administration on CD4 T-cell count and on the CD4/CD8 T-cell ratio     To study the relationship between the level of immune activation and the level of residual     HIV replication in plasma To study the effect of Rosuvastatin administration on lipid     profiles and the correlation between the HDL cholesterol and the CD4/CD8 T-cell ratio To     evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day   "
107822|NCT01874730|"     This is a multi-centre study to take place in approximately 3 centers in Seoul, South Korea.     The study will be carried out as a prospective, randomized, controlled, multicenter, clinical     trial in patients undergoing colorectal surgery. The purpose of this study is to determine if     an enhanced recovery strategy paying close attention to the type and amount of fluid given     during the surgery with proper monitoring combined with a comprehensive perioperative pain     management will have a better post-operative outcome compared to institutional standard of     care (SOC), in patients undergoing surgery of the colon. One of the fluids used, Volulyte®,     is an intravenous solution used to treat low blood volume. The Volulyte® solution being used     in the study and the monitor used are approved by the Korean Food and Drug Administration   "
107823|NCT01874717|"     Use lay language.      To compare patient level of cooperation during dental care under conscious sedation with     midazolam according to the administration route   "
107824|NCT01874704|"     A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical     errors, and also increase coronary heart disease. Emergency physicians subjectively complain     of stress related to changes in work shifts. Several potential biomarkers of stress have been     described, but never investigated in emergency physician, who may represent a good model of     stress due to the complex interplay between stress (life-and-death emergencies, which is the     defining characteristic of their job), lack of sleep and fatigue due to repeated changes in     shifts.The aim of this study was to compare biomarkers in emergency physicians working a     24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day     (clerical work on return from leave). We also followed these markers three days following     each shift (D3/24hS and D3/14hS).   "
107825|NCT01874691|"     This study is to build a Chinese national registry and surveillance system for acute     myocardial infarction(AMI) to obtain real-world information about current status of     characteristics, risk factors, diagnosis, treatment and outcomes of Chinese AMI patients; And     to propose scientific precaution strategies aimed to prevent effectively from the incidence     of AMI; And to optimize the management and outcomes of AMI patients through implementation of     guideline recommendations in clinical practice, and analysis and development of effective     treatment strategies; And to create cost-effective assessment system.   "
107826|NCT01874678|"     Objectives:        1. Primary Objective:           To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin          in Taiwanese advanced NSCLC patients from that gained from Japanese population        2. Secondary Objectives:      A. To assess progression free survival B. To assess overall survival C. To bridge the safety     profile by assessing the toxicities and tolerability   "
107827|NCT01874665|"     The purpose of this study is to evaluate the efficacy and safety of ponatinib in patients     with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure     of prior tyrosine kinase inhibitor (TKI) therapy.   "
107828|NCT01874652|"     The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast     Implant (LWBI) in breast augmentation.   "
107829|NCT01874639|"     Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the     most effective possible tool for hemostasis allows a bleeding decrease during liver     transection and thus could reduce postoperative morbidity.      In the past decade, the improvement of techniques of transection of the hepatic parenchyma     was one of the most important factors to ensure the hepatectomy safety. But the clinical     performances of these technological innovations (ultrasound dissectors, monopolar     radiofrequency probes and dissection devices using pressurized water) remain still unclear.      The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology     of transcollation combining a source of radiofrequency associated with a conductive liquid     (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump     Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of     radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device     consists in maintaining the tissue to a temperature of 100°C, while using a conductive liquid     which acts as process of cooling and avoids the drying out of tissues, smoke, risks of     electric arc and overheating met with conventional electrosurgery. This device allows the     coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the     postoperative morbidity and mortality due to a decrease of blood loss and biliary leak. These     clinical benefits could be translated by an improvement of the direct and indirect costs     associated to the surgery. However the Aquamantys® technology has not been scientifically     validated in the context of the hepatic surgery, and this technology is expensive due to the     purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®) and to the investment     in a generator (Aquamantys Pump Generator®).      Consequently, it is essential to realize a study measuring the clinical and medical economic     impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.   "
107830|NCT01874626|"     This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose,     parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older     with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all     eligibility criteria, will be randomized into the study and will receive either the active     treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount     equivalent to a 4 inch line of investigational product to the affected ankle approximately     every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of     the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a     24 hour period. Duration of treatment with the investigational product is 7 days.   "
107831|NCT01874613|"     Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects     and orbital floor defects.      Functional and aesthetic outcome is assessed by patient and doctor.   "
107832|NCT01874600|"     The seizure detection and warning system is an ambulatory system designed to monitor and     analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert     caregivers that a seizure is occurring.   "
107833|NCT01874587|"     The Phase III study will include 174 patients with locally advanced oropharynx carcinoma,     receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant     systemic therapy. Two arc-IMRT treatment arms will be compared: one standard arm based on     the use of a single pre-treatment planning and one experimental arm (adaptive RT) based on     a weekly replanning to spare the salivary glands. The main objective is to increase by 25%     the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing     local control. The secondary objectives are to increase the salivary flow (scintigraphy),     reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE),     while maintaining local control (stopping rule of the trial if difference>15%). 174 patients     will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human     Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality     Assurance) will be performed.   "
107834|NCT01874574|"     Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of     osteoarthritic knee patients.   "
107835|NCT01874561|"     This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized     study, to compare treatment with intravenous custirsen at 640 mg (highest intended     therapeutic dose) with placebo. The purpose of this study is to assess the effect of     custirsen treatment on cardiac conduction and repolarization (electrical activity of the     heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity     consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The     moxifloxacin arm is un-blinded but the ECG readings are blinded.   "
107836|NCT01874548|"     The purposes of this study are: (1) to develop magnetic resonance (MR) imaging and     spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2) to     understand the function of human papillomavirus (HPV) infection and autophagy (a cellular     catabolic degradation response to stress) in the metabolic alterations in cervical cancer.   "
107837|NCT01874535|"     To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole     (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with     symptomatic erosive esophagitis   "
107838|NCT01874522|"     The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral     solution containing equivalent amounts FTD and TPI.   "
107839|NCT01874509|"     Alcohol is one of the leading contributors to premature mortality and disability. Most people     with alcohol problems will never seek treatment. There is a need to develop alternate ways to     help problem drinkers outside of formal treatment settings.      One promising strategy is Internet-based interventions for problem drinkers. The first     randomized controlled trial found that the investigators could reduce alcohol consumption by     about six drinks per week at a six-month follow-up using a minimal, personalized feedback     Internet-based intervention. The investigators second randomized trial demonstrated that an     extended Internet-based intervention that contained a range of cognitive-behavioural and     relapse prevention tools could produce greater reductions in problem drinking compared to     that provided by the same minimal intervention at a six-month follow-up. Building upon this     research, the current project will assess whether this extended Internet-based intervention     can have a sustained impact on problem drinking. Specifically, the major objective of this     project is to conduct a randomized controlled trial comparing the impact of an extended     Internet-based self-help intervention for problem drinkers to a minimal Internet-based     intervention in the general population of problem drinkers over a two year period.      Problem drinking participants will be recruited through media advertisements across Canada     and will be randomly assigned to the minimal or extended Internet-based interventions.     Six-month, twelve-month and two-year drinking outcomes will be compared between experimental     conditions. It is predicted that participants receiving the extended Internet intervention     will display sustained improved drinking outcomes compared to participants in the minimal     Internet intervention condition. This programmatic line of research will advance the science     of Internet-mediated intervention.   "
107840|NCT01874496|"     Slow release iron capsules have been designed based on the gastric delivery system. Iron     absorption from those capsules administered with and without meals will be measured using     stable iron isotopes.   "
107841|NCT01874483|"     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004     following multiple dose administration over 14 days.   "
107842|NCT01874470|"     The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal     denervation in subjects with resistant hypertension by using Allegro renal denervation system   "
116375|NCT01762631|"     The purpose of this study is to determine if digital photography on a Smartphone and the     Remote Food Photography Method (RFPM) can estimate infant formula intake. This is a     validation study; there is no hypothesis.   "
107848|NCT01874392|"     This clinical trial is a feasibility study to assess the performance of an Artificial     Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with     type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin     (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed     study is to explore the feasibility of using multiple insulin delivery routes in order to     mimic the physiology of both first- and second-phase insulin secretion. The intent is to     exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and     utilize the conventional subcutaneous route for management of basal insulin and as     second-phase meal-related insulin.   "
107849|NCT01874379|"     In the M-TIJRP protocol the investigators will utilize two Integrative Medicine modalities in     a randomized, controlled study using either the 'M'-Technique® developed by Jane Buckle, PhD     or Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ with nature sounds to determine     their effects on a specific group of pre- and post-operative patients, compared to no     integrative medicine intervention - considered Standard of Care. A total of 225 patients     undergoing surgical hip or knee replacement will participate; one third of the patient     population will receive the 'M'-Technique touch intervention, one third will receive Tusek's     Guided Imagery intervention delivered by headsets monitored by therapists from our Center for     Complementary Medicine (CCM) and one third will comprise the control group, consisting of     routine preoperative & postoperative care without integrated intervention.      Patients will be asked to complete Pain and Anxiety scales at four different timepoints     throughout their hospital stay. These will occur at Same Day Surgery (pre-operatively), and     Post Operatively Day 0, Day 1 & Day 2.      Rationale: Patients are often at their most vulnerable just prior to surgery when their     stress and anticipation are high and again immediately afterward when their energy is lower     and their bodies are trying to accommodate after an invasive procedure. In addition, the     patient and his or her family sense a lack of control and feel a rise in anxiety over the     possible outcomes. This stress, anxiety, and pain associated with surgery and recovery can     increase complication rates and slow recovery times resulting in longer hospital stays.   "
107850|NCT01874366|"     -  Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and          Pharmacodynamics of Single and Multiple Ascending Doses of P11187        -  It will be conducted in three parts, as described below:        -  Part I will be the Single Ascending Dose (SAD) study        -  Part II will be the Multiple Ascending Dose (MAD) study        -  Part III will be the food effect evaluation   "
107851|NCT01874353|"     Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has     already improved by taking platinum based chemotherapy. The patients must also have a fault     in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the     cells of the body; if this protein doesn't work properly it can increase the chance of     getting cancer. The aim of this study is to see whether patients taking olaparib tablets last     longer until their cancer gets worse, compared to those taking the placebo tablet. The study     is also looking to see if there is an overall improvement to how long the patients survive     whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life     whilst living with ovarian cancer.   "
107852|NCT01874340|"     To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing     multiple sclerosis.   "
107853|NCT01874327|"     The study will evaluate the efficacy of a novel intervention implemented in a classroom     setting aimed at improving joint attention and joint engagement skills with infants who are     at risk of developing an Autism Spectrum Disorder.   "
107854|NCT01874314|"     This will be a single center, open label, crossover study to evaluate the safety and     tolerability of multiple dose levels of SQ109.   "
107855|NCT01874301|"     Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the     major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of     ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of     life. One of the hallmarks of chronic constipation is slow progression of contents through     the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that     are difficult to expel. Previous studies have shown that probiotics improve colonic transit     times in constipated patients. In addition, several other studies, employing a range of     different probiotic strains, have shown a significant increase in defaecation frequency and     improvement in stool consistency. However, the clinical relevance of these results is     uncertain, due to small sample sizes and limitations in study methodology. The current study     is designed to compare changes in gut transit time and gastrointestinal symptoms following 4     weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled     manner, in adults with constipation.   "
107856|NCT01874288|"     An open-label, dose-escalation trial of the safety, tolerability, pharmacokinetics (PK),     biological, and clinical activity of DI-Leu16-IL2 administered to patients with CD20     (B-lymphocyte antigen CD20) positive Non-Hodgkin Lymphoma (NHL) that have failed standard     rituximab-containing therapy. Following peripheral blood B cell depletion with rituximab (if     needed) each patient will receive DI-Leu16-IL2 administered as a subcutaneous (SC) injection     for three consecutive days every three weeks.   "
107857|NCT01874275|"     The primary objective of this investigation is to assess the effectiveness of transcutaneous     electrical nerve stimulation applied using VECTTOR to reduce the symptoms of Duchenne     Muscular Dystrophy and reduce the impact of DMD upon the participants' quality of life.      The primary outcome measures will include:        1. increased muscle strength,        2. increased range of joint motions and        3. improved sleep parameters of ASI, N3 and REM.   "
107858|NCT01874262|"     The purpose of this study is to evaluate whether the mobile-phone based patient support has     an impact on the adherence and persistence of ticagrelor treatment or on lifestyle changes     that will have a positive impact on the cardiovascular risk factors.   "
107884|NCT01873924|"     This study aims to assess the natural history of Batten disease by obtaining information     about the motor, behavioral, and functional capabilities of individuals with Batten disease     (Neuronal Ceroid Lipofuscinosis). This study will also refine and validate the Unified Batten     Disease Rating Scale (UBDRS) as a clinical rating instrument for Batten disease.   "
116676|NCT01758718|"     Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of     superficial punctate keratopathy and score of wearing glasses to correct refractive errors     were measured.   "
107859|NCT01874249|"     The purpose of this randomized clinical trial is to evaluate the utility of noninvasive     markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic     Fatty Liver Disease (NAFLD) by ultrasound.      The primary objective is to determine the effectiveness of noninvasive markers for detect of     advanced fibrosis in patients with diagnosis of fatty liver disease.      The secondary objectives are:        -  To determine the increase in health care with the specialist (gastroenterologist or          endocrinologist).        -  To determine which noninvasive evaluation strategy favors any treatment of fatty liver          disease.   "
107860|NCT01874236|"     The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint     blocks.   "
107861|NCT01874223|"     The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of     life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure     the severity of cough, breathlessness, and changes in cough and disease-related quality of     life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have     been used in other types of disease, but have not all been tested and validated in patients     with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related     QOL questionnaire scores will correlate with physiologic markers of IPF severity and     worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are     important to assess the benefit of investigational drugs under development to treat patients     with IPF.   "
107862|NCT01874210|"     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are     among the most extensively studied gut microbial metabolites, and are associated with     cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect     findings suggest that chronic kidney disease influences the colonic microbial metabolism with     higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore,     this study aims to elucidate the influence of renal dysfunction on microbial metabolism and     to test the hypothesis that chronic kidney disease patients carry a different fecal     metabolite profile.   "
107863|NCT01874197|"     An investigator-initiated, prospective, consecutively enrolling, non-randomized single     institution clinical evaluation of the safety and effectiveness of physician modification of     a currently FDA-approved off the shelf thoracic aortic stent graft (COOK Zenith® TX2®) to     preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic     aneurysms.      The primary objectives of this study are to determine whether physician modified branched     endovascular grafts are a safe and effective method of treating patients with     thoraco-abdominal aortic aneurysms.   "
107864|NCT01874184|"     This randomized clinical trial studies a group-based lifestyle intervention or usual care in     measuring biomarker levels in participants at high risk for breast cancer. Studying the     effects that changes to daily eating and exercise habits can have on the body's hormone     levels and the body's ability to activate proteins may help doctors identify interventions     for individuals at high risk for breast cancer.   "
107865|NCT01874171|"     Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the     developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection.     HPV+OPSCC is considered a distinct disease entity, affecting younger patients and has a good     prognosis following treatment. Subsequently, patients can live with the considerable side     effects for several decades.      Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated     similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing     platinum-based compounds) in head and neck cancer, but is potentially less toxic.      Results of this trial will be used to determine the optimum treatment of this debilitating     cancer, with the primary aim of decreasing toxicity and improving quality of life for     HPV+OPSCC patients.   "
107866|NCT01874158|"     The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women     weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is     detectable post treatment and to examine potential confounders to clearance such as bacterial     vaginosis.   "
107867|NCT01874145|"     This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and     tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW)     administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.   "
107868|NCT01874132|"     Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly     population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are     among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to     levels of physical activity, and is lower in individuals who exercise and have higher     functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American     College of Sports Medicine, and the American Heart Association have recommended 20-30 min of     moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3     days a week in the case of vigorous exercise.The same organizations also suggest the     inclusion of resistance training in order to improve functional fitness. Therefore, the     purpose of this study was to compare different exercise modalities in long-term changes of     CVD risk factors and physical fitness among older adults.   "
107869|NCT01874119|"     The purpose of this study is to investigate the effectiveness of intravenous fosaprepitant     therapy to reduce nausea and vomiting during the treatment of high dose interleukin-2 (HD     IL-2) therapy for metastatic melanoma or metastatic renal cell carcinoma. Fosaprepitant is an     intravenous (IV) medication that is FDA- approved for use in adults for the prevention of     nausea and vomiting during chemotherapy. Fosaprepitant works by blocking the neurokinin-1     receptor, which is a receptor in the brain that is known to cause nausea and vomiting. Past     studies estimate that up to 70% of patients undergoing treatment with HD IL-2 will have     nausea and/or vomiting. While fosaprepitant has been used in clinical practice to treat     nausea and vomiting during HD IL-2, there have not been any studies done to see how well it     works. All patients will receive treatment (IV fosaprepitant) during the study during either     the first or second hospital admission for HD IL-2. On the admission that the subject is not     receiving IV fosaprepitant, the subject will receive placebo (a medicine that looks like     fosaprepitant, but is not active). The study is double-blinded, which means neither the     subject, nor the study doctor will know to which group you have been assigned to that     admission (IV fosaprepitant or placebo). This study design was chosen to limit the potential     for bias, which means the trial was designed to try to ensure that unknown factors do not     affect trial results. When patients start the study, patients will be randomly assigned to     one of two groups: those who receive treatment (IV fosaprepitant) first and those who receive     placebo first. During the first admission, subjects will be given the IV fosaprepitant or IV     placebo during admission. During the second admission, subjects will 'crossover' and receive     the other treatment that they did not receive during the first admission. Improvement in     nausea and vomiting will be assessed by counting the number of nausea and vomiting episodes,     recording if the subject needs additional medication for nausea and vomiting, and by using     patient questionnaires.   "
107873|NCT01874067|"     This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West     England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory,     rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand     pain, swelling and stiffness. People find they help but there is little research testing     this. Of the five small studies published: two found little or no benefit; one found similar     effects from arthritis and ordinary thermal gloves; two found some benefits. Testing if     gloves work helps therapists and patients judge if they will help.      This is a feasibility study to help us plan a future trial testing if arthritis gloves work     for people with arthritis. We aim to find out: the rate we can recruit people to the study;     if OTs can assess people's hands and provide gloves as agreed; how many people do we need to     take part in a trial; what do people think (if any) is the gloves' most important effect and     how long should we test them for? We will analyse the data to see what effect the gloves     have.      The study will last 12 months. People will get arthritis gloves as part of their usual care.     The OTs have agreed a standard way of assessing and providing the gloves to ensure best     practice across departments. The assessments include: difficulties using hands, pain and     stiffness levels, and measuring hand and finger joint size and movement. People can take part     if they: have one of the three types of arthritis; are willing to wear Isotoner three-quarter     length gloves; can attend the usual 4 week review appointment for re-assessment; will allow     us to use their anonymized hand assessments. We will also interview some people about their     views of the assessment and their treatment. Each patient will be involved for 4-8 weeks.   "
107874|NCT01874054|"     The purpose of this study is to assess safety and efficacy of brentuximab vedotin in     combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is     an open-label, 2-stage study designed to determine the recommended dose level of bendamustine     in combination with brentuximab vedotin. The study will assess the safety profile of the     combination treatment and determine what proportion of patients achieve a complete remission.   "
107875|NCT01874041|"     The objectives of this study were to investigate the effects of massage therapy and occlusal     splint therapy in the electromyographic activity and mandibular range of motion (ROM) in     individuals with temporomandibular disorder (TMD) and compare the results with those obtained     in a group of individuals without this disorder. Twenty-eight volunteers with TMD were     randomly distributed into two groups, massage therapy and occlusal splint. Both treatments     lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to the control     group. The Fonseca's anamnestic index was used to characterize TMD and allocate the     volunteers to either the intervention groups or control group. The electromyographic activity     and Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way     analysis of variance with the Bonferroni test was used for inter and intragroup comparisons     (level of significance was set to 5%). Cohen's d was used to calculate the effect size.   "
107876|NCT01874028|"     To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients     with Wilson's disease.   "
107877|NCT01874015|"     This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and     feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in     fistulizing Crohn's disease.   "
107878|NCT01874002|"     Patients with stenosis in one or more coronary artery are often treated with a percutaneous     coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the     vessel open over time.      The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo     stent combines a drug eluting technique and an endothelial cell attracting layer. The drug     coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting     layer is designed to ensure rapid coverage of the stent struts with vascular wall cells.      The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in     routine clinical practice. In total 1000 patients will be registered and followed for five     years.   "
107879|NCT01873989|"     This study is designed to develop an effective treatment intervention for chronic pain,     symptomatic hypogonadism, and opioid addiction   "
107880|NCT01873976|"     Cardiomyopathy is a disease of the heart muscle. It is rare, but it can be serious.     Cardiomyopathy in children can result in death, disability, heart transplantation or serious     heart rhythm disorders. Natural substances in the blood called cardiac biomarkers can be     measured in the laboratory and could be a less invasive way (compared to echocardiograms or     MRIs) to detect heart dysfunction in children with cardiomyopathy. Little is known about how     useful and valid cardiac biomarkers are in the diagnosis and determination of the symptoms in     children with cardiomyopathy. The long-term goal of this project is to study how helpful     measuring cardiac biomarkers in children with cardiomyopathy is to their doctors in managing     the care of these patients as well as improving their overall health. Measures of these     cardiac biomarkers could help doctors in determining how best to care for a child with     cardiomyopathy, including when to consider heart transplantation as a treatment option.   "
107881|NCT01873963|"     Cardiomyopathy in children is a serious disease which can result in death, disability, heart     transplantation or serious heart rhythm disorders. Doctors know little about the causes of     cardiomyopathy but would like to learn more. In fact, up to 50-75% of cases in children have     no known cause. For this reason, the purpose of this study is to identify genes that cause     cardiomyopathy or that influence how people with cardiomyopathy do over time. These findings     could improve disease prevention, surveillance, early management, and prognosis.   "
107882|NCT01873950|"     This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their     effects on electrophysiological and other clinical parameters. The underlying purpose is to     determine if depolarization and repolarization effects caused by drugs with differing ionic     channel mechanisms can be distinguished from one another, and to gauge the sensitivity and     specificity of novel signal analyses for detection of depolarization and repolarization     changes. Secondarily, to evaluate the exposure response relationship and drug induced effects     on the heart rate biomarker relationship.   "
107883|NCT01873937|"     Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical     situations. With the advent of new LED-based (light emitting diode) light sources, the need     of further clinical experiments aiming to compare the effectiveness between them is     paramount.   "
107885|NCT01873911|"     Hypothesis #1: Factor analysis of the revised Sanfilippo Behavior Rating Scale (SBRS) will     identify a group of externalizing behaviors and a group of Klüver-Bucy syndrome-like     behaviors as two different factors that are at least partially independent.      Hypothesis #2a: Children with MPS III will show more hyperlocomotion, fearlessness,     asociality and noncompliance than children of similar cognitive ability with MPS I.      Hypothesis #2b: These behaviors will become more frequent and/or intensify over time,     consistent with the Cleary and Wraith (1993) model. Quantifying them will provide a more     empirical framework for staging disease progression.      Hypothesis #3: Brain volumetric analysis and diffusion-tensor imaging will reveal     abnormalities of frontal and temporal lobe structures that will correlate with externalizing     and Klüver-Bucy syndrome-like behaviors, respectively.      Hypothesis #4. Loss of cognitive and language function as measures of neurologic decline will     directly precede or co-vary with behavioral decline.      The primary objective of this study is to identify the behavioral phenotype and its neural     basis in MPS III (Sanfilippo syndrome). Is the behavioral phenotype similar to that of     Klüver-Bucy syndrome, and is there evidence for amygdala abnormality? The secondary objective     of this research study is to develop easily administered, sensitive and specific     neurobehavioral and neuroimaging markers to characterize the behavioral phenotype(s) of MPS     III; to track their progression; and to delineate their neural substrates. Such markers are     critical for identifying the stage of disease for each patient, and to measure treatment     outcome. Although we know that severe cognitive decline is one essential characteristic of     MPS III, the other highly salient characteristic is a range of abnormal and disruptive     behaviors that can include, but go well beyond, childhood noncompliance and oppositionality.     These behaviors set Sanfilippo syndrome apart from the other MPS disorders. They cause major     disruption in the child's familial, school, and community environments. Delineating these     behavioral abnormalities will help in better understanding the neurological disease.   "
107886|NCT01873885|"     This study is an exploratory Phase 1 randomized, double-blind (Investigator and study subject     and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose escalation study     that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension.   "
107887|NCT01873872|"     We have designed this study to measure the effect of normal flora supplementation, using     available probiotics, on the incidence of Clostridium difficile-associated diarrhea      in a population of general inpatients who are receiving antibiotics.   "
107888|NCT01873859|"     The purpose of this study is to determine whether metformin causes lactic acidosis in     diabetic patients with preserved kidney function, undergoing coronary angiography or     angioplasty with new contrast media.      In other words is it necessary to discontinue metformin before these procedures, even when     Iodixanol is used as contrast media, which is isosmolar agent and much more safer than     urografin which was the main agent in the previous studies that were the base of present     guidelines?   "
107889|NCT01873833|"     This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate,     and trastuzumab work in treating patients with human epidermal growth factor receptor 2     (HER2)-positive metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine     and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Giving capecitabine and cyclophosphamide     daily may kill more tumor cells. Lapatinib ditosylate may stop the growth of tumor cells by     blocking some of the enzymes needed for growth. Monoclonal antibodies, such as trastuzumab,     can block tumor growth in different ways. Some block the ability of the tumor to grow and     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.     Giving capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab together may be     an effective treatment for breast cancer.   "
107890|NCT01873820|"     The purpose of this study is to compare the tolerance of two forms of vitamin C in adults     with sensitivity to acidic foods.   "
107891|NCT01873807|"     Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying     condition with less-used drugs could overcome resistance,reduce tumor burden, and most     importantly, spare enough time for slow-growing GVL effect following immune reconstitution to     finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011     (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL,     resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2     conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16     conditioning regimen was associated with high transplantation-related mortality (TRM), which     might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013,     substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less     cross-resistance and immune suppression and reducing TRM.   "
107892|NCT01873794|"     Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer     treatment - can severely interfere with activities of daily living, and has even been     reported to be a factor in patient requests for hastened death. CRF can represent a serious     clinical problem years after all treatment has ended. There is currently no effective     treatment for CRF. The purpose of this study is to investigate whether systematic exposure to     light (from a commercially available Litebook) reduces CRF or other symptoms.   "
107893|NCT01873781|"     Age related cataracts are responsible for about 51 percent of blindness worldwide and     according to the WHO affect about 20 million people, according to the WH . As cataract     surgery is firstline treatment in the western world, there is a constant attempt to improve     artificial intraocular lenes (IOL).      As for this study, the investigators seek to compare four different IOL designs in in a     psychophysiological setting, allowing to assess the impact of these IOLs on vision and     psychological processing of visual information.      As these IOLs also have downsides, such as reduced light intensity or image alterations, the     subjective preference and overall impression shall be investigated. The healthy subjects look     through a stable spectacle frame mounted onto a table, which enables the investigator to     insert the different IOLs. This would allow subjective testing of IOLs before surgery.   "
107894|NCT01873768|"     Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss     following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic     acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee     arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and     EACA provide similar blood decreasing effects following TKA or whether one drug provides a     superior effect over the other in reducing patients' blood loss.   "
107895|NCT01873755|"     This proposal will address the existent gaps in the literature by identifying barriers and     facilitators to participation in physical activity in inner-city minority elementary     schoolchildren with asthma, more that half of whom are also overweight; developing and     refining a school-based intervention in partnership with the community to improve physical     activity; and conducting a pilot randomized controlled trial of the intervention to determine     feasibility and obtain preliminary data for a future large-scale trial.   "
107896|NCT01873742|"     Feedback in psychotherapy involves clients monitoring therapy process and progress, and on a     frequent basis clients register these data into online questionnaires. These data are then     fed back to the therapist, hence informing about the process and progress in therapy. This     information can be shared with the client, something that may enhance the client involvement     in evaluating and planning of the therapy. The same data can be used for research purpose.     This randomized controlled multicenter study within Norwegian couple and family contexts will     explore the effects of feedback in natural settings, and it collaborates closely with a     similar American study in Chicago/Evanston, Ill.   "
107897|NCT01873729|"     The primary aim of this study is to assess whether naltrexone as a monotherapy is effective     in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that     increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa     opioid receptor antagonist, it increases dopamine in the brain.      We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults     with ADHD.   "
107898|NCT01873716|"     This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated     carotid endarterectomy. The nine patients will receive an injection of Indocyanine green     (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus.      Immediately following endarterectomy, the resected specimen will be immersed in normal     saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be     performed.      The investigators hypothesize that compared to controls, ICG-injected patients will     demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of plaque.   "
107899|NCT01873703|"     The purpose of this randomized, double-blind, placebo-controlled study is to determine the     safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and     FDA approved treatment for Myelodysplastic Syndrome (MDS).   "
107900|NCT01873690|"     The purpose of this research study is to test whether administering one dose of an antibiotic     before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary     infections compared to not taking an antibiotic. This is an important topic to study because     urinary tract infections are one of the most common complications after this procedure and     there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study     results will benefit future patients either by decreasing the rate of infections or     decreasing the use of unnecessary antibiotics.   "
107901|NCT01873677|"     This study is to evaluate the efficacy and safety of M518101 in subjects with plaque     psoriasis.   "
107902|NCT01873664|"     The purpose of this study is to examine the possibility of using jaw-tapping training as a     self-exercise for developing memory and preventing dementia in elderly subjects with memory     disturbances using functional magnetic resonance imaging (fMRI).   "
107903|NCT01873651|"     The aim of the study is to describe the results after > 10 years due to a prosthesis implant.   "
107904|NCT01873638|"     Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical     techniques for the management of symptomatic gallstone disease and both techiques have shown     to be feasible for day surgery. However, to our knowledge the long-term outcome between these     approaches has not been compared in randomised trials as day surgery procedures.   "
107905|NCT01873625|"     Osteoarthritis of the knee is one of the most common causes of disability among elderly.     Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as     knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding     bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted     MRI as increase in signal density. Patients are treated initially by pain management. In     patients who don't response to first line treatment invasive treatment like total knee     replacement is done. The investigators designed this clinical study with the aim of     evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem     cells (BM-MSCs) in 60 patients with knee osteoarthritis.   "
107906|NCT01873612|"     The overall aim with this project is to investigate the effect of dexmedetomidine on control     of breathing in healthy volunteers and to compare it with propofol at the same degree of     sedation.   "
107907|NCT01873599|"     In this study the investigators plan to recruit 70 patients reporting high levels of stress     to test the impact of Positive Affect Journaling. Patients randomized to use the online     intervention will be asked to journal about one of seven topics, several days each week, for     three months. The topics (e.g., What went well) are designed to help the individual focus     on some positive aspect of their life or themselves over the past day. Each topic is based on     prompts shown to be effective in studies of up to one week in duration. In the summer of     2012, our research team pilot tested each prompt with 20 patients with high levels of     anxiety, which led to important changes to the prompts, to increase their potential impact.     The main aim is to understand the impact of Positive Affect Journaling on psychological     distress, as measured by the National Health Interview Survey.   "
107908|NCT01873586|"     The objective of this study is to prospectively evaluate the performance of Integra's     OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for     instrumented posterolateral spine fusion, as compared to local autograft.   "
107909|NCT01873573|"     The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection at     the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening     of their esophagus and decrease the need for repeat dilations.   "
107910|NCT01873560|"     Fractional flow reserve (FFR) is a physiologic index for the determination of     ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even     multiple anatomic imaging parameters have been widely used in clinical practice for the     assessment of optimal stent procedure. Prognostic value between post-stent FFR (FFRpost) have     been rarely evaluated in patient treated with DES. This multicentre, prospective registry was     aimed to evaluate influence of physiologic parameters on the clinical outcome after DES     implantation.   "
108061|NCT01871584|"     The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in     order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy     to standard preparation solution.      Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard     preparation solution.   "
107911|NCT01873547|"     The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China.     The methods to treat SCI patients in sequela stage update are poor. Though traditional     rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve     the neurological disorders of these patients, such as sensory disturbance, dyskinesia,     autologous adjustment of blood pressure, dysfunction of urination, defecation and     perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is     unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint     stiffness. However, it can not repair the damaged nerve function. Studies show that     mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI     in animals without any severe side effect.      In this study, 300 patients will be divided into three groups and the investigators will use     mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also     follow up 100 patients who only receive rehabilitation and another 100 patients who accept     neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare     the efficacy of these two treatments.   "
107912|NCT01873534|"     The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10     subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses,     followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have     stable Hgb levels will start the washout period of one to eight weeks. During the washout     period, 30 subjects whose Hgb are < 10.0 will complete the baseline assessment to confirm     their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a     1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic     overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day     29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period,     the trial subjects will be observed for an additional 28 days to allow safety and     immunogenicity assessments.   "
107913|NCT01873521|"     It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to     pressure support to provide noninvasive ventilation to children will result in a decrease in     the number of children with moderate to severe respiratory failure failing noninvasive     ventilation and requiring endotracheal intubation. It is further hypothesized that     noninvasive ventilation with NAVA compared to pressure support will result in a decrease in     the length of mechanical ventilation, and the length of PICU and hospital stay.   "
107914|NCT01873508|"     This single-center, open label, randomized, 3-period cross-over study will compare 3     modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized     to one of six sequences to receive single oral doses of RO4917523 slow, target and fast     release modified release (MR) capsules along with a reference intravenous microdose with the     target capsule. A washout period of at least 21 days will occur between treatments.   "
107915|NCT01873495|"     The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for     consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first     complete remission following induction with cytarabine and an anthracycline, and also to     assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and     older with acute AML in first complete remission following 3 consolidation courses with     omacetaxine.   "
107916|NCT01873482|"     Pre-agricultural societies almost universally used healing ceremonies that involved     reverence, rhythm and dance in the presence of a healer. It is believed that we are wired     for such experiences and they foster an integrative mode of consciousness similar to that of     mindfulness based stress reduction, which has been shown to have therapeutic effects in a     variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has     developed a healing ceremony based in sub-Saharan African traditions. The investigators plan     is to have 25 subjects with a variety of clinical conditions participate in this ceremony.     Subjects will then be asked to write a commentary about their experience and to participate     in a focus group discussion. It is anticipated that the study will give us some idea of how     promising this approach would be and what kinds of patients might benefit. Safety issues are     minimal and include the possibility of injury (though the dancing is not strenuous) and     psychological distress.   "
107917|NCT01873469|"     Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM).     Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission     tomography (PET), where in some patients also tumour manifestations can be detected that are     not visible in MRI investigations.      The aim of the study is to investigate the association of high [11C]MET tracer uptake before     postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in     patients with glioblastoma multiforme. Also site of recurrence will be correlated with the     [11C]MET imaging before and early during radiochemotherapy. All imaging information will be     included in treatment planning or treatment decisions.      The study provides a basis for later radiation dose escalation trials on the base of [11C]MET     imaging.   "
107918|NCT01873456|"     The hypothesis is that there is a profit potential by implementing a multifactorial     nutritional intervention among frail elderly since this will result in an improved     nutritional status, functional capacity and improved quality of life.   "
107919|NCT01873443|"     This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the     Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety     of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the     scheduled visits in Study CT-P10 1.1   "
107920|NCT01873430|"     The aim of this study is to investigate the sun protective effect of melatonin, when used as     a cream applied before sun exposure.      Sun exposure induces erythema as indication of an inflammatory reaction in the skin. It is     proven that the amount of free radicals in the skin are increased by UV exposure.     Furthermore, it is known that melatonin is a potent antioxidant. It is hypothesized that     melatonin can be protective against the UV induced release of free radicals by acting as a     radical scavenger and thereby protect against UV-induced cellular damage.   "
108133|NCT01870635|"     The primary objective is to determine if the administration of a single dose of oral     ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in     intravenous (IV) rehydration therapy in children presenting for emergency department care     with vomiting and diarrhea in Pakistan.   "
107921|NCT01873417|"     The primary objective of this study is to evaluate the effect of symptomatic therapies on     gastrointestinal (GI)-related events reported by participants with relapsing forms of     multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical     practice setting.      The secondary objectives of this study are as follows:        -  To evaluate GI-related events requiring symptomatic therapy and the role of those          therapies over time in participants with relapsing forms of MS initiating therapy with          DMF in the clinical practice setting.        -  To evaluate GI-related events that lead to DMF discontinuation after the use of          symptomatic therapy in participants with relapsing forms of MS initiating therapy with          DMF in the clinical practice setting.   "
107922|NCT01873404|"     The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010     (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered     3 times per week for 1 week.      The secondary objectives of this study in this study population are as follows: To explore     the duration of the effect of BG00010 in improving pain; To explore the dose response curve     on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum     exposure to BG00010.   "
107923|NCT01873391|"     The objective of this study is to assess which factors influence the pain perceived during     diagnostic anesthesia-free hysteroscopy.   "
107924|NCT01873378|"     The primary outcome of this study is to assess if the GnRHa administration before cold loop     hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical     procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic     therapy in terms of distension liquid absorption and duration of the procedures.   "
107925|NCT01873365|"     The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic     neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults     greater than or equal to sixty years of age.   "
107926|NCT01873352|"     The objective of this trial is to determine the role of renal sympathetic denervation in the     prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a     catheter-based AF ablation procedure is planned. Patients will be randomized to either AF     catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.   "
107927|NCT01873339|"     This study will determine the effect of single and repeat administration of darapladib, a     novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2     (Lp-PLA2) currently under clinical development on the pharmacokinetics of a single oral dose     of midazolam, a cytochrome P450 3A4 (CYP3A4) probe substrate. This study will investigate the     inductive and inhibitory effect of darapladib on CYP3A4 metabolic pathway.   "
107929|NCT01873313|"     The primary goal is to evaluate ropivacaine blood concentrations during and after local     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee     replacement surgery. The investigators plan to measure these levels by testing blood samples     taken over a timed period.      This will allow us to confirm whether the current regimen of local anaesthetic use is within     safe limits.   "
107930|NCT01873300|"     Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal     sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal     incisions (belly area cuts), by using an endoscope to create a small cut at the most inner     layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of     the esophagus. The investigators are studying whether subjects who undergo Endoscopic     Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar     formation and wound infection than with laparoscopic or open surgery.   "
107931|NCT01873287|"     Concussion, a mild traumatic injury common in children and adolescents, is a complex     pathophysiological process affecting the brain. The lay press is inundated with reports of     tragic consequences of concussion, and children are not immune.      Persistent postconcussive symptoms (PCS) is defined as the persistence of somatic, cognitive,     physical, psychological or behavioural changes lasting more than one month following injury.     PCS significantly impacts children and their family's quality of life through school     absenteeism, depressed mood and loss of activities.      Validated, easy-to-use prognosticators do not exist for clinicians to identify children at     highest risk for PCS. As a result,physicians cannot accurately inform children and parents     whether they should expect longer symptoms, nor initiate pharmacotherapy or other management     to reduce the occurrence or severity of PCS.      The investigators objective is to derive and validate a clinical prediction rule for the     development of PCS in children and adolescents presenting to the emergency department (ED)     following acute head injury. The investigators have three aims: (1) determine PCS incidence     at one-month follow-up in children aged 5-17 who sustain a concussion; (2) derive a rule to     predict PCS from variables present in the history and physical examination; and, (3) assess     the accuracy, reliability and acceptability of the prediction rule in a subsequent cohort.     Using a prospective, multicentre study at nine large Canadian pediatric EDs, the     investigators will recruit the largest prospective epidemiological cohort of children with     concussions in the literature.      This work will provide rigorous evidence to determine PCS incidence in children and its     impact on quality of life. The results will enable clinicians to identify children at highest     risk for PCS, optimize treatment and provide families with realistic anticipatory guidance.     This study will also establish a strong and vital evidence base to advance concussion     research.   "
107932|NCT01873274|"     The objective of this study is to investigate the absorption of menaquinone-7 from a     nutrient-enriched dairy product compared to a general dairy product enriched with     menaquinone-7 and a menaquinone-7-containing supplement.   "
107933|NCT01873261|"     This pilot study will be an observational no randomize study in which the NiNAVAped protocol     will be applied solely to the NIV NAVA arm.   "
107934|NCT01873248|"     This is a prospective, Phase 1-2, single center study in a total of 100 subjects with     Neuroendocrine Tumors (NETs). Study participants will receive a one-time administration of     68Ga-DOTATATE and undergo a PET/CT imaging study, to investigate its suitability as a PET     imaging agent for NETs.   "
108174|NCT01870102|"     Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate     the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR     (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single     dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR     (Pelubiprofen 45 mg) in healthy male volunteers   "
108637|NCT01864044|"     The aim of this observational study was to describe usual practices in lymphedema management     in France.      It was the opportunity to assess the effects of these practices on lymphedema volume in a     large number of patients, to identify predictive factors of response, and to assess the     safety of this therapy.   "
130326|NCT01579136|"     The purpose of this study is to determine if home blood pressure monitors can help decrease     blood pressure in patients with diabetes at a low income clinic.   "
107935|NCT01873235|"     Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney     disease (ADPKD) have opened up possibilities of new therapies to prevent disease progression.     High quality clinical investigations in patients with ADPKD, however, pose significant     challenges to investigators including limited access to patients with ADPKD,insufficient     guidance by experienced investigators and lack of resources to conduct these studies.      The Polycystic Kidney Disease Research Clinical and Translational Core (P30) aims to     establish an infrastructure that will assist investigators in designing and conducting     highest quality clinical and translational research focused on a diverse group of patients     with ADPKD.      Objective 1: To establish a Mid-Atlantic cohort of ADPKD patients (N=200) with baseline     clinical phenotyping performed at the General Clinical Research Unit of the University of     Maryland School of Medicine.      Objective 2: To establish a state-of-the-art biobank of specimens from the ADPKD cohort     including serum, plasma,urine and DNA.      Objective 3: To develop a collaborative network of physicians and practices in the     Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer     patients for future studies and trials.      Objective 4: To establish a web-based registry of ADPKD patients in the Mid-Atlantic area.   "
107936|NCT01873222|"     This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to     evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS)     imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.   "
107937|NCT01873196|"     This research will test alternative methods of ensuring compliance with recommended     preparation and targeting of supplementary foods for malnourished children under five years     of age.      The hypotheses that the proposed study intends to test are as follows:        1. With appropriate behavior change communication (BCC) and social support, and with          provision of CSB and FVO in the correct proportions, it is possible to get women to          prepare CSB with oil in the recommended ratio of 100:30, and in quantities just          sufficient for the target child.        2. Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with          appropriate messaging and with instructions to direct the food to children and to          prepare the CSB with oil in the recommended ratio and feed as instructed will result in          better compliance.   "
107938|NCT01873183|"     In bariatric surgery functional and feasible non- or mini-invasive modalities for monitoring,     and ideal/lean body weight estimates are addressed to meet up individual variability in     hydration needs, and to avoid hyperhydration.      The aim of the study is to evaluate need of perioperative hydration by comparing conventional     monitoring (the control group) to a more advanced approach (individualized goal-directed     therapy, IGDT) (the intervention group). In addition to conventional cardiovascular     monitoring (ECG, non-invasive blood pressure, Sp02) preoperative transthoracic     echocardiography (TTE) and a intraoperative perioperative mini-invasive pulse-contour device     (FloTrac™) will be used for the purpose.   "
107939|NCT01873170|"     This study is being done to understand if using birth control causes changes in the immune     cells within the reproductive tract (including the cervix and the lining of the uterus) of     healthy women. Immune cells are important because they help prevent infections from starting     and help fight infections that have started. Immune cells are also the type of cells that HIV     (human immunodeficiency virus) infects so understanding more about them will help to better     understand how to prevent the spread of HIV.      Immune cells will be studied from the reproductive tract of women who want to start using one     of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the     levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal     implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women     who are not using birth control and who are not at risk of pregnancy for comparison.   "
107940|NCT01873157|"     Late antibody-mediated rejection (AMR) after kidney transplantation is defined as a separate     rejection entity. So far, no appropriate treatment has been established for this rejection     type. One promising strategy could be the targeting of alloantibody-producing plasma cells.     There is now accumulating evidence that the proteasome inhibitor Bortezomib may substantially     affect the function and integrity of non-malignant alloantibody-secreting plasma cells. The     impact of this compound on the course of late AMR , however, has not yet been systematically     investigated. In the planned phase IIa study we will examine the effect of Bortezomib on late     AMR after kidney transplantation. We plan an initial cross-sectional HLA antibody screening     of 1000 kidney transplant recipients to identify patients with detectable donor-specific     antibodies (DSA). DSA-positive recipients will be subjected to kidney allograft biopsy to     detect morphological features consistent with AMR. Forty-four patients with late AMR will be     included in a randomized double-blind placebo-controlled parallel-group intervention trial.     Patients in the active group will receive two cycles of Bortezomib (4 x 1.3 mg/m2). The     primary end point will be the course of estimated GFR over 24 months after randomization.     Secondary endpoints are the course of DSA levels and protein excretion, measured GFR after 24     months, transplant and patient survival, and the development of acute and chronic     morphological lesions in 24-month protocol biopsies. Our study will clarify the impact of an     innovative anti-humoral strategy on the deleterious effects of late AMR processes.   "
107941|NCT01873144|"     The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula     (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute     viral bronchiolitis in infants in improving respiratory distress and comfort and reducing     length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).   "
107948|NCT01873053|"     This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase     II clinical trial and aimed at osteoarthritis of the knee.      Patients who signed informed consent voluntarily and eligible for this study are assigned     randomly to one of 3 groups after 2 week-Washout period.        1. st group (experimental) : WIN-34B 450mg BID        2. nd group (experimental) : WIN-34B 900mg BID        3. rd group (Comparator) : Placebo BID      Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4     weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination,     questionnaire, laboratory experiment.      After 8 weeks(Visit 4), researchers check adverse effects and current medication status via     telephone interview.      After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers     check patients' physical examination, questionnaire, adverse effects and current medication     status.   "
107942|NCT01873131|"     The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate     0.5% gel can help infants who have a hemangioma. The investigators also want to find out if     pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too     many side effects.      Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels     grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through     the body. No one knows what causes blood vessels to group together. Most birthmarks don't     hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have     these birthmarks on their bodies, like between the eyebrows. These birthmarks usually     disappear within the first few months to years of life. These birthmarks tend to disappear     spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's     health, which occurs in about 1 in 3 children with hemagiomas.      Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug     Administration (FDA) for treating hemangioma.      The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not     approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas     have received timolol maleate. The results so far show that timolol maleate may be helpful     and safe in treating hemangiomas in infants.      An important question being tested in this study is whether pulsed-dye laser or timolol     maleate can prevent hemangioma from growing when used very early after birth.   "
107943|NCT01873118|"     Preparation of patients for discharge is a primary function of hospital-based nursing care     and readiness for discharge is an important outcome of hospital care. Inadequacies in     discharge preparation have been well-documented and linked to difficulty with self-management     after hospital discharge and with increased likelihood of emergency department (ED) use and     readmission. Prior studies by the research team have led to recommendations for     implementation of discharge readiness assessment as a standard nursing practice for hospital     discharge.      The investigators will conduct a multi-site study to determine the impact on post-discharge     utilization (readmission and ED visits) and costs of implementing discharge readiness     assessment as a standard nursing practice for adult medical-surgical patients discharged to     home. The study tests, in a stepped approach, the impact of implementing discharge readiness     assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the     incremental value of informing the nurse assessment with the patient's perspective     (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents     risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF     protocol).      HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital     readmissions and ED visits within 30 days post-discharge compared to patients discharged     under usual care conditions.      HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer hospital     readmissions and ED visits within 30 days post-discharge compared to patients discharged     using the RN-RHDS protocol.      HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a     Nurse-Initiated Action Form [NIAF] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer     post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS     protocol; the effect will be strongest for patients with low RHDS scores.      Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as     standard practice, by comparing cost-savings from reduced post-discharge utilization against     implementation costs.   "
107944|NCT01873105|"     The purpose of this study is to improve the experience of discharge of adult medical surgical     patients through improved discharge preparation communication between patients and care team     members, with subsequent improvement in the post-discharge experience. Obtaining multiple     perspectives on discharge readiness creates the opportunity for patient and care team to     partner in identifying deficiencies in discharge readiness that warrant anticipatory,     compensatory, or corrective interventions prior to discharge, with the goal of averting     post-discharge problems and utilization. The results will also inform development and     translation of tools for assessment of discharge readiness to clinical care environments.      Specific Aims are to:        1. Describe patterns of communication about discharge and collaboration among members of          the health care team        2. Conduct psychometric testing of 3 forms of the Readiness for Hospital Discharge Scale          (RHDS - MD, RN, Patient)        3. Describe relationships between care team communication, patient perceptions of quality          of discharge preparation and perceived readiness for discharge, care team (RN and MD)          assessments of discharge readiness, and post-discharge outcome ( post-discharge coping          difficulty, Emergency Department (ED) use, and 30 day readmission.        4. Determine the impact of an intervention with the inpatient care team to improve          discharge preparation communication.      H1: Patient perceptions of discharge readiness, post-discharge coping difficulty, ED use and     readmission will improve following a care team educational intervention about discharge     preparation, compared to pre-intervention baseline measures.      H2: Care team members will report improved frequency and amount of discharge preparation     communication following a care team educational intervention about discharge preparation,     compared to pre-intervention baseline measures.      H3: RN-MD collaboration will increase following a care team educational intervention about     discharge preparation, compared to pre-intervention baseline measures   "
107945|NCT01873092|"     Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is     progressive over many years and is largely irreversible. Advanced COPD is associated with     arterial oxygen desaturation leading to a series of complications and, ultimately, decreased     survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the     exact target of oxygen saturation that actually translates into improvements is not known.     The basis for the work in this proposal is to focus a new approach to measure oxygen     desaturation linked to daily activity. Accelerometers are used to measure daily activity and     then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile     for individual patients. The three main objectives of this study are 1) determine the     feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients     with chronic lung disease; 2) determine if serial AOM-derived data is reliable and     reproducible; and 3) determine thresholds of oxygen desaturation that are associated with     different activity profiles   "
107946|NCT01873079|"     Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and     therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the     important complications related to sphincterotomy. This study determines the role of proton     pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP     and sphincterotomy.   "
107947|NCT01873066|"     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong     insulin therapy. Children and adolescents with T1D need regular insulin injections or the     continuous insulin delivery using an insulin pump in order to keep blood glucose levels     normal. We know that keeping blood sugars in the normal range will help prevent long-term     diabetes-related complications involving the eyes, kidneys and heart. However, achieving     treatment goals can be very difficult particularly due to the risk of low glucose levels     (hypoglycaemia). One solution is to use a system where the amount of insulin injected closely     matches the blood sugar levels on a continuous basis. This can be achieved by what is known     as a closed-loop system where a small glucose sensor placed under the skin communicates     with a computer containing an algorithm that drives a subcutaneous insulin pump. We have been     testing such a system in Cambridge over the last five years in children and have found that     this system is effective, and superior to usual insulin pump therapy, at maintaining tight     glucose control. More recently the system has been tested overnight, in the home setting, for     three weeks in adolescents during a pilot single-centre study.      The next step is to evaluate use of the closed loop system day and night over a period of 7     days (phase 1) and 21 days (phase 2) in adolescents with type 1 diabetes. In the present     study we are planning to study 24 (12 phase 1 ans 12 phase 2) young people aged 10-18 years     on insulin pump therapy. This study will involve two 7 (phase 1) and 21 (phase 2) day home     study periods, during which glucose levels will be controlled either by an automated     closed-loop system or by subjects usual insulin pump therapy combined with continuous glucose     monitoring alone in random order. Prior to the closed-loop study period, there will be a     training period in the clinical research facility, which will allow participants to     familiarise themselves with the closed-loop system before going home.      We aim to to determine the effect of the closed-loop computer algorithm in keeping glucose     levels between 3.9 and 10.0 mmol/L during the daytime and overnight.   "
107998|NCT01872403|"     Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung     squamous cell carcinoma has a better tumor response rate and safety, therefore.The main     purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel /     carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.   "
116677|NCT01758705|"     The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the     HRQoL, work productivity and activity impairment in patients with psoriasis using adalimumab.   "
107949|NCT01873040|"     This study will assess the effectiveness of social media website devoted to vaccines to     change immunization knowledge, perceptions and behavior. If effective, this intervention will     represent an innovative, low cost and broadly applicable resource to reduce parental     vaccination concerns.      The study has two hypothesis:        1. Parents receiving usual care plus social media website will demonstrate higher early          childhood immunization rates to parents receiving either usual plus non interactive          website or usual care only.        2. Parents receiving usual care plus social media website will demonstrate positive changes          in knowledge, attitudes and beliefs supporting vaccination compared to parents receiving          either usual care plus non-interactive website or usual care only.   "
107950|NCT01873027|"     The aim of this randomized study is to evaluate the impact of Optical frequency domain     imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent     (DES) as compared with Intravascular ultrasound (IVUS) guidance.   "
107951|NCT01873014|"     safe study of Chinese Herbs to Treat Thyroid Diseases With Different Iodine   "
107952|NCT01873001|"     The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics     (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone     acetate in healthy adult male participants.   "
107953|NCT01872988|"     Hepatocellular carcinoma (HCC) is one of the most common solid cancers worldwide, and chronic     hepatitis B virus (HBV) infection is the most common etiology of HCC in Asia. Transarterial     chemoembolization (TACE) is the standard treatment for patients with unresectable HCC in the     BCLC intermediate stage, but the HCC recurrence rates and long-term mortality rates are quite     high. These intermediate-staged HCC patients usually need repeated TACE due to tumor     recurrence, and they may die of HCC progression or liver decompensation after repeated TACE.     Improved liver function and decreased liver disease progression due to oral antiviral therapy     have been proven to be effective for chronic hepatitis B, and oral antiviral therapy may keep     better liver reserve and provide better chance for HCC patients received TACE. In addition,     chronic HBV infection is one of the most important factors for HCC development, and antiviral     therapy can improve the outcomes after curative treatment. However, the evidence of improving     outcomes of HCC patients underwent TACE by oral antiviral therapy is lacking. Moreover,     Tenofovir Disoproxil Fumarate (TDF) is one of the most potent oral antiviral agents, and its     safety and very low long-term viral resistance rate have been also reported. There is no     study to evaluate the impacts of TDF for HBV-related HCC patients underwent TACE. Until now,     routine antiviral therapy for HBV-related HCC patients underwent TACE has still not been     recommended by current guidelines. The hypothesis of this study is that a potent oral     antiviral therapy for patients with HBV-related HCC patients receiving TACE improve patients'     outcomes   "
107954|NCT01872975|"     This randomized phase III trial studies standard or comprehensive radiation therapy in     treating patients with early-stage breast cancer who have undergone surgery. Radiation     therapy uses high-energy x rays to kill tumor cells. It is not yet known whether     comprehensive radiation therapy is more effective than standard radiation therapy in treating     patients with breast cancer   "
107955|NCT01872962|"     The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus     concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced     nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC     patients.   "
107956|NCT01872949|"     The study is designed to observe the clinical outcomes of heart failure patients treated with     C-Pulse® System in the usual manner and according to the approved indications and     contraindications.   "
107957|NCT01872936|"     The purpose of this open-label study is to assess the safety, tolerability, antiviral     activity, genotype resistance associated with virological failure, pharmacokinetics and     pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and     ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to     pegylated-interferon alpha and ribavirin.   "
107958|NCT01872923|"     The primary goal of this extension study is to further investigate the tolerability and     efficacy in a phase I setting in order to see whether lower doses than the initial study dose     of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or     improved safety and tolerability profile in combination with comparable signs of efficacy.   "
107959|NCT01872910|"     The main purpose of this study is to test if a single dose of LY3023703 relieves pain after     wisdom teeth removal. The study will last about one week for each participant, not including     screening.   "
107960|NCT01872897|"     This study is being conducted to assess the effectiveness of the Compound Sodium Alginate     Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus     in patients diagnosed with Gastroesophageal Reflux Disease (GERD).   "
107961|NCT01872884|"     The purpose of this study is to evaluate whether general anesthesia or sedation technique is     preferable during embolectomy for stroke, measured in terms of three months neurological     impairment. In addition we study if there is any difference between the methods regarding     complication frequency.   "
107962|NCT01872871|"     Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants.     Although, local anesthetics reduce pain to some extent, eye examination still remains as a     painful procedure. The investigators aimed to evaluate the effect of oral paracetamol     combined with local anesthetics for pain relief during ophthalmological examination.   "
107963|NCT01872858|"     Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed     cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive     function, MRI and other sides at given time. The investigators hypothesize that cilostazol is     more efficient and safer than aspirin in patients with VCIND.   "
108018|NCT01872143|"     The purpose of this study is to determine whether transcranial direct current stimulation     (tDCS) is effective in the treatment of psychiatric disorders in which available treatments     are either ineffective or not tolerated   "
108293|NCT01868542|"     This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of     Levemir® (insulin detemir) administered once daily according to two titration algorithms     after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin     treatment with or without other anti-diabetic drugs (OADs).   "
107964|NCT01872845|"     Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL)     cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery     disease. However, there is lack of solid evidence whether a specific kind of statin have the     superiority against other statins in clinical outcomes. Furthermore, recent data have showed     that several kinds of statin could have an adverse effect on glucose metabolism and increase     the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate     marker of atherosclerosis to predict long term cardiovascular outcomes in not only general     population but also patients with established coronary artery disease. Consequently, we will     evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of     rosuvastatin in patients with established coronary artery disease. Additionally, we will     assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well     as adverse outcomes including insulin resistance and new onset diabetes compared with     rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to     rosuvastatin 20mg regarding CIMT at 1 year follow up.   "
107965|NCT01872832|"     This study will explore the safety, tolerability, and serum uric acid lowering effect of     RDEA3170 in healthy Japanese males to allow comparison with the Western population.   "
107966|NCT01872819|"     This clinical trial uses a laboratory test called a high throughput sensitivity assay in     planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim     is to try to identify drugs that may be effective in killing leukemia cells for those     patients who will not be cured with conventional chemotherapy. This assay will test multiple     drugs simultaneously against a patient's own donated blood sample. The goal is to use this     laboratory assay to best match a drug to a patient's disease.   "
107967|NCT01872806|"     The main objective of this study is to investigate whether radiofrequency electromagnetic     radiation, induced by a dialing mobile phone placed on the body, causes a change in     electrophysiology.   "
107968|NCT01872793|"     Despite the importance of nutritional status in patient's outcome, there is no gold standard     for nutritional assessment. Traditional techniques used in healthy subjects to assess     nutritional status cannot be used in cirrhotic patients due especially to ascites and     peripheral edema, and altered rates of biochemical markers due to liver failure.      Bioelectrical impedance vector analysis has emerged as a useful method to assess body     composition and nutritional status especially in patients at the extremes of body weight     (fluid overload, excess of adipose tissue, etc.).      With previous results from our research group, BIVA showed to be useful for evaluating     cirrhotic patients.      The aim of this study is to validate our previous results and validate BIVA for nutritional     assessment in patients with liver cirrhosis   "
107969|NCT01872780|"     The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic     population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.   "
107970|NCT01872767|"     After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will     be made. These patients will undergo detail clinical, biochemical and microbiological     examination at baseline. Clinical examination and Biochemical evaluation will be done daily     and signs of infection will be noted. Patients will undergo microbiological screening for     infection every 48 hours. Patients suspected or diagnosed to be suffering from infections     will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site     and etiology (bacterial and/or fungal) of infections will be noted in all patients at     admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care     Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care     Unit).   "
107971|NCT01872754|"     The purpose of this study is to determine whether the use of Target-Controlled Infusion (TCI)     of Remifentanil can deliver better conditions for performing bronchial fibroscopy with     spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of     Propofol.   "
107972|NCT01872741|"     This randomized prospective study was designed to compare the clinical, functional and     aesthetic results of two surgical techniques for microsurgical clipping of anterior     circulation aneurysms   "
107973|NCT01872728|"     A bilateral facial block (infraorbital and infratrochlear) will be performed immediately     after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine     (intervention group) or saline as control. Intravenous saline or morphine will be     administered at the end of surgery in intervention or control groups, respectively. In case     of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups     will receive intravenous morphine titration. The total perioperative morphine consumption     (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain     intensity, presence of nausea/vomiting and patient's satisfaction will be compared between     groups.   "
107974|NCT01872715|"     The purpose of this study is to characterize rosacea patients', being treated with Oracea,     perception through visual analog scale reporting.   "
107975|NCT01872702|"     The overall aim of this study is two fold:        1. to pilot targeted chemo-elimination of plasmodium falciparum malaria in known areas of          artemisinin resistance in South East Asia.        2. to understand the micro-epidemiology of malaria in these areas; chiefly, the prevalence          and importance to on-going transmission of sub-clinical p.f malaria infections.   "
107976|NCT01872689|"     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will     evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background     idiopathic pulmonary fibrosis (IPF) therapy or as combination therapy with pirfenidone     background therapy in participants with idiopathic pulmonary fibrosis. Participants will be     randomized to receive either lebrikizumab or placebo subcutaneously (SC) every 4 weeks.   "
108019|NCT01872130|"     The purpose of this study is to evaluate a new instrument that shines light and takes digital     pictures of skin. The goal is to develop a technique that may enable fast and accurate     assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell     carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal     microscope to determine whether this technique may be useful in the future for helping Mohs     surgeons remove cancers. In the future, patients may benefit with shorter surgery and     improved care.   "
130996|NCT01570374|"     The purpose of this study is to determine whether internet-administered cognitive behavior     therapy is a feasible treatment for generalized anxiety disorder.   "
107977|NCT01872676|"     The aim of the present study was to assess the immediate effects of upper thoracic     manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii     muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women     of the university community were randomly allocated to an experimental group (n = 13) and a     placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment     T3)was performed. Infrared thermography was used to determine changes in skin surface     temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect     sympathetic activity. Images were taken prior to manipulation, immediately after and both     five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc Bonferroni     test and the independent samples t-test were used for the intragroup and intergroup     comparisons, respectively, with the level of significance set to 5%.   "
107978|NCT01872663|"     The aim of this study will be to investigate the effects of using physical therapy resources     in the postoperative morbidly obese individuals undergoing gastroplasty.      It is believed that the application of these various features of physiotherapy after     abdominal surgery may contribute differently in restoring lung function and prevention of     pulmonary complications and can thus identify the resources that can contribute more     effectively in post-operative bariatric surgery.   "
107979|NCT01872650|"     Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical leading     to serious consequences and complications at reoperation.      The investigators initiate a prospective, randomized, controlled, multicenter trial to assess     whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects     undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an adhesion     prevention barrier for colorectal surgery will be compared with the control group at the     second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of     adhesions to the incision site.   "
107980|NCT01872637|"     Hospitalization increases the risk for new disability in older adults. In the current health     care system, home health physical therapy is understudied and often does not return older     adults to prior levels of function. The proposed evidence-based multicomponent intervention     that combines high intensity strength training and motor control based systems of gait and     balance training will advance clinical practice by providing an intervention strategy for     practitioners. If successful, improving patient function and decreasing re-hospitalization     rates and falls will have large cost saving implications.   "
107981|NCT01872624|"     The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal     cells in patients with severe pulmonary emphysema is safe and will contribute to increase     quality of life.   "
107982|NCT01872611|"     The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,     0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among     diabetic participants following cataract surgery.   "
107983|NCT01872598|"     The objective is to compare the efficacy and safety of oral masitinib 3 or 4.5 mg/kg/day in     combination with cholinesterase inhibitors and/or memantine to placebo in combination with     cholinesterase inhibitors and/or memantine in patients with mild-to-moderate Alzheimer's     disease.   "
107984|NCT01872585|"     The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting     intervention for implementation with female adult caregivers who have or are at risk for     long-term interpersonal conflict with family members, children, or significant others and are     caring for a child between the ages of birth and 7 years.   "
107985|NCT01872572|"     This was a Phase 1a, single-center, double-blind, randomized, placebo-controlled study of the     safety, tolerability, PK, and PD of single ascending doses of RB006 administered as an SC     injection, with and without IV RB007 (an active control agent for RB006), in healthy young     volunteers. The study originally planned to enroll 4 cohorts of 8 subjects each (N=32);     however, upon review cohort (Cohort 1-A) was necessary in order to fully define the PK     profile of SC RB006. Therefore, 36 subjects were enrolled in this study.      Each cohort was balanced by sex with no more than 2/3 of one sex enrolled in any particular     cohort (i.e., 5 of 8 subjects in each cohort). No subject participated in >1 dose group, and     progression to the next higher dose only occurred if the prior dose level was well tolerated,     as assessed by a Safety Review Committee (SRC)   "
107986|NCT01872559|"     The study is designed to evaluate a new imaging modality, 3-dimmensional sonographic     volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is     currently in place. Those patients who are scheduled to have an ultrasound as part of their     infertility treatment will be offered the opportunity to have additional measurements done at     the time of their ultrasound; these additional measurements will take less than 2 minutes and     do no require any additional sonograms, tests, or interventions. All patients are eligible     (oocyte donors and autologous oocyte patients) and only patients with a serum estradiol >     2000pg/ML will be enrolled in the study. After the additional measurements are obtained, the     results will be digitally stored. The results of the 3D sonographic volumetric analysis will     then be correlated with the patients' IVF performance.   "
107987|NCT01872546|"     The expertise in the characterization of transcriptomics profile in lesional psoriatic skin     and on the availability of innovative therapy for these patients.The investigators propose to     follow the modification of the skin transcriptomics profile in psoriatic patients during     successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non     lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The     investigators will focus on the modification of the cytokine signature in these skin     lesions and of some markers of keratinocyte inflammation. The modification of the     transcriptomics profile induced by the biotherapy will be correlated to the clinical response     Psoriasis Area and Severity Index.   "
107988|NCT01872533|"     The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences     insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to     moderate hypoxia (~ 15% O2, similar to conditions at an altitude of ~7500 feet) will improve     glucose metabolism.   "
107989|NCT01872520|"     Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the     Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia     Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the     real world, and observe the adverse drug reactions/ adverse drug events during treatment.   "
107990|NCT01872507|"     The effect of breathing biofeedback training to influence the function of the cardiac     autonomic nervous system at rest and in activity in children with cerebral palsy.      Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most     common injury that causes physical handicapped in childhood. There are a few researches that     investigated the autonomic function in cerebral palsy children. Those researches found     hyperactivity of the sympathetic autonomic system, including high resting heart rate compare     to their typically developed pears. The recommended treatment for cerebral palsy is activity,     muscle strengthening and mobility. The impairment in the autonomic system influences the     everyday function and has correlation with secondary morbidity.      As far as we know there are no researches who investigated the following issues.      In this study we would like to:        1. Describe the autonomic cardiac function, Breathing function, motor function and the          correlation between them in children with cerebral palsy.        2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic          breathing.        3. Test the influence of breathing training on Heart rate variability parameters at rest,          in aerobic test right after the breathing training program and one month after, in          children with cerebral palsy   "
107991|NCT01872494|"     Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma     and rich periosteum and joint capsule innervation, patients after general anesthesia     immediately feel acute pain.The use of appropriate postoperative analgesia in patients with     thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic     via multilumen catheters that deliver directly to wound sites have been used for     postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will     make the mode of analgesia a better tolerated and more palatable option for patients. The aim     of this study is to examine the effects of using local anaesthetic infusion catheters     following posterior thoracolumbar surgery, and compares the outcomes of patients managed     using intravenous analgesia pump infusion of systemic opioids.   "
107992|NCT01872481|"     Phantom Limb Pain (PLP) is a neuropathic chronic syndrome, characterized by a painful     sensation in a body part that has been amputated. The incidence of phantom limb pain is     between 50-80% of all amputees, however, additional risk factors as psychological trauma,     blood loss, and infection increases its incidence after a traumatic amputation in landmine     victims. Satisfactory management is often difficult to achieve and different clinical trials     with medical and surgical measures have yielded unsatisfactory results. The response rate     with pharmacologic treatment is around 30% using conventional medication as opiates and     N-methyl-D-aspartate (NMDA) receptor antagonists, which is not significantly different from     response rates with placebo.      Recent case series have shown that repetitive Transcranial Magnetic Stimulation (rTMS) of the     motor cortex can display an effectiveness that goes from 52% to 88% in the treatment of some     refractory neurogenic pain cases which is quite superior to conventional management. However,     the use of this type of treatment has not been studied in patients with phantom limb pain     secondary to landmine injuries. The main objective of this trial is to evaluate the efficacy     and safety of rTMS in the treatment of phantom limb pain in landmine victims.      A double blind randomized placebo-controlled clinical trial, including 54 landmine victims     with PLP will be performed. At the time of enrollment, a complete medical evaluation will be     performed and those patients who meet the inclusion criteria will be randomly assigned to one     of two groups, to receive rTMS in series of 20 trains of 6 s in duration (54-s intertrain     interval) at a stimulation rate of 10 Hz (1200 pulses) and an intensity of 90% rest motor     threshold using an active coil or a sham coil. Sessions will be administered 5 days a     week (Monday to Friday) during two consecutive weeks. The stimulation will be directed to the     primary motor cortex contralateral to the amputated limb. Response will be evaluated by     measuring the pain intensity at baseline and after each session using a visual analog scale.     These measurements will be repeated 2 weeks after the end of the treatment scheme, in order     to determine the duration of the analgesic effect of rTMS   "
107993|NCT01872468|"     The propose of study is to study if an informative intervention and a structured follow-up     carried out in health centres of primary care in patients with chronic kidney failure, stage     3, is more effective than the current follow-up in slowing the disease progression measured     by the glomerular filtration rate.   "
107994|NCT01872455|"     n-3 Polyunsaturated fatty acids (PUFAs) supplementation reduces systemic inflammation and     improves renal and cardiovascular prognosis in kidney transplant recipients. A good patient     compliance is often difficult to obtain because bad tasting fish oils are used as n-3 PUFA     source. Therefore, we explored whether n-3 beneficial effects can be obtained by     administering a diet based on n-3 rich foods.   "
107995|NCT01872442|"     Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the     advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a     with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the investigators     address the question of the efficacy and safety of dasatinib in combination with low dose of     Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia     in Chronic phase.   "
107996|NCT01872429|"     The impact of parathyroidectomy (PTX) on the bone mineral parameters in dialysis patients     with secondary hyperparathyroidism (SHPT) remains unclear. The investigators performed this     study to present the short- and long-term impact of PTX on calcium, phosphorus and intact     parathyroid hormone control in dialysis patients with severe SHPT after operation. In     particular, the investigators evaluate the impact based on the achievement of recommendations     of the current clinical practice guidelines for bone and mineral parameters in dialysis     patients after PTX.   "
107997|NCT01872416|"     At present, there is no standard second-line treatment of refractory and relapsed SCLC,     topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide second-line     treatment of small cell lung cancer currently being explored, Anthracycline antibiotics is a     cell cycle non-specific anticancer drugs could inhibit the synthesis of DNA, DNA and     dependent RNA, its wide antitumor spectrum, widely used in malignant hematologic diseases and     lung cancer and other solid tumors. Jacot W, et al evaluated epirubicin combined with     ifosfamide (EI) for treatment of refractory and recurrent SCLC in 70 cases, the objective     response rate (ORR) reached 21.4%, including 1 cases of complete remission, 10% other     patients obtained stable disease (SD), all the patients had a median survival of 3.9 months,     most (71%) patients with neutropenia, platelet count and anemia are also common, showed that     EI treatment of refractory and relapsed SCLC is effectively controlled, toxicity.      In view of epirubicin combined with ifosfamide (EI) scheme is effective and safety in the     treatment of refractory and relapsed SCLC, the investigators will use liposomal doxorubicin     plus ifosfamide second-line treatment of refractory and relapsed small cell lung cancer, may     obtain better tumor remission rate, improve the prognosis of the patients.   "
108294|NCT01868529|"     This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic     (the effect of the investigated drug on the body) response of insulin degludec (insulin 454)     with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.   "
107999|NCT01872390|"     The purpose of the START Study is to identify an effective, cost-effective, acceptable     intervention that addresses programmatic, structural and psychosocial barriers to ART     initiation and retention during TB treatment, with the ultimate goal of improving health     outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster randomized     trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV clinics in Berea     district. Clinics are randomized to deliver the combination intervention package (CIP) or     standard of care (SOC), with stratification by facility type. The experimental intervention     will be delivered to all HIV-infected TB patients in TB/HIV clinics randomly assigned to CIP.     In TB/HIV clinics assigned to SOC, usual care procedures for ART initiation and retention     will be delivered.      Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes.      Compared to HIV-infected TB patients attending SOC clinics, HIV-infected TB patients at CIP     clinics will have superior HIV- and TB-related outcomes, including:        -  Greater ART initiation during TB treatment        -  Shorter time to ART initiation        -  Greater retention in ART care        -  Higher adherence to ART        -  Greater change in CD4+ count        -  Greater TB treatment success (completion and cure)        -  Greater sputum smear conversion        -  Higher adherence to TB treatment      Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable     than alternative resource uses.   "
108000|NCT01872377|"     Currently the standard treatment for locally advanced, unresectable pancreatic cancer     consists either of chemotherapy by itself or a combination of chemotherapy plus radiation     therapy or no treatment at all. Unfortunately, no treatment thus far has been able to provide     patients with a consistent chance for a cure although there are rare patients who will live     for many years after treatment. For most patients the chemotherapy or chemotherapy plus     radiation will maintain or improve quality of life by keeping the cancer under control for a     period of time.      Approximately 25-30% of patients with early pancreatic cancer who are able to have the cancer     completely removed surgically will live beyond 5 years and will be considered cured. This     tells us that aggressive treatment directed at the tumour in the pancreas can lead to cure.     For the majority of patients who can not have an operation, giving more radiation as part of     the treatment may be a strategy that results in better control of the tumour in the pancreas     which may or may not result in patients living longer.      The purpose of this study is to test the safety of adding a higher dose (a boost dose) of     radiation using a radiation unit called CyberKnife when combined with standard chemotherapy     and radiation for patients with locally advanced, unresectable pancreatic cancer.      Participants on this study will receive a 'boost' dose of radiation which consists of 3     treatments over 1 week. The participants will then receive the standard of care treatment of     chemotherapy and standard radiation therapy over a 5 week period, which will be followed by     the conventional 20 weeks of chemotherapy alone. The participants will then be followed for     progression of disease and toxicity related to the boost treatment for up to 5 years.   "
108001|NCT01872364|"     Expenditures on material supplies and medications constitute the greatest per capita costs     for surgical missions. We hypothesized that supply acquisition at nonprofit organization cost     would lead to significant cost-savings compared to supply acquisition at US academic     institution costs from the provider perspective for hernia repairs and minor procedures     during a surgical mission in the Dominican Republic.   "
108002|NCT01872351|"     The purpose of this study is to determine whether therapy that has been shown to be     beneficial for mitochondrial diseases is also beneficial for Chronic Fatigue Syndrome (CFS)     patients. This study is a chart review of previous CFS patients who received daily     conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed     nutraceutical supplements included alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids     (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin.      Twelve CFS male and female patients between the ages of 20-70 years will be recruited to     participate in this pilot study. Subjects will be eligible to participate if they meet the     criteria for CFS of the Centers for Disease Control and Prevention (CDC). These include     persistent, unexplained fatigue for at least 6 months, concurrent with four of the following:     impaired memory/concentration, sore throat, new headaches, unrefreshing sleep, muscle pain,     multi-joint pain, tender lymph nodes, and post-exertional malaise.   "
108003|NCT01872338|"     The purpose of this study is to test a psychotherapeutic intervention that integrates     cognitive therapy and mindfulness meditation techniques to prevent suicide in military     Veterans.   "
108004|NCT01872325|"     The main goal of this project is to help 9-1-1 emergency medical dispatchers save the lives     of more cardiac arrest victims. The investigators will develop teaching tools to help the     dispatchers recognize abnormal breathing that may indicate a victim as having a cardiac     arrest. After training sessions, the investigators will see if dispatchers can get better at     recognizing abnormal breathing, how often they give CPR instructions, and if use of the     teaching tool will increase bystander CPR and the number of victims leaving the hospital     alive.   "
108005|NCT01872312|"     This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.   "
108006|NCT01872299|"     SICA-HF is a prospective, multicentre, multinational, longitudinal, pathophysiological     evaluation study, which is being conducted in 11 centres across six countries. SICA-HF     receives funding from the European commission's Seventh Framework Programme (FP7/2007-2013)     under grant agreement no. 241558 (SICA-HF) and from the Russian Ministry of Science and     Education within the file transfer protocol R&D in priority fields of the S&T complex of     Russia 2007-2012 under state contract number 02.527.11.0007. The aim of SICA-HF is to     provide detailed characteristics of co-morbidities of heart failure at baseline and over     time, particularly with regards to obesity, cachexia, and type 2 diabetes.   "
108007|NCT01872286|"     Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel     disease. This study was aimed to compare the performance between the frequency-altering AKE-1     capsule and the Pillcam SB2 in patients with suspected small bowel disease.   "
108008|NCT01872273|"     Moderate exercise is recommended to improve cardiovascular health in obese and overweight     people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting     blood sugar, and elevated blood lipids. This study is being done to determine how platelets     respond when a person performs an initial period of moderate exercise.   "
108009|NCT01872260|"     The purpose of this trial is to inform the future clinical development of the two     investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha     inhibitor).      This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate     the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and     BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole     (Arms 3 and 4).      The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further     characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the     combinations. Optional crossover for patients who have progressed while on dose escalation or     dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet     combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted     after protocol amendment 6.      Approximately 250 adult women with ER+/HER2- locally advanced or metastatic breast cancer     will be enrolled.   "
108010|NCT01872247|"     HP-hMG, recombinant FSH (r-hFSH) and a combination of r-hFSH/r-hLH, are commonly used for     ovarian stimulation in infertile women undergoing IVF/ICSI treatments. Several publications     have compared the effectiveness of these compounds, in terms of clinical outcomes.      The aim of our study is to investigate the effects of three different ovarian stimulation     protocols (HP-hMG, r-hFSH and r-hFSH/r-hLH), in a pilot prospective observational study,     evaluating the effects of recombinant LH and extractive hCG (with LH like activity) on the     biological outcome as well as on the clinical outcome. We will use the apoptosis rate of the     cumulus cell, usually discarded after oocyte collection, as molecular biomarker to assess the     oocyte quality, as biological outcome. The clinical outcome was estimated measuring     implantation and ongoing pregnancy rates within and between the three different ovarian     stimulation protocols   "
108011|NCT01872234|"     The purpose of this trial or study is to determine if pacemaker therapy can be a beneficial     alternative to conventional medical therapy in patients with a history of moderate heart     failure. The investigators are looking to enroll approximately 180 people in this trial.     Patients will be randomized in two groups. One group will be implanted with a pacemaker and     will continue to receive conventional medical therapy as prescribed by their doctor. The     second group will continue to receive conventional medical therapy as prescribed by their     doctor and will not be implanted with a pacemaker. Clinical histories, physical exams, and     external device testing will be collected both at the time of enrollment in the trial and     during follow-up study visits. Patients who enter the study will be seen for study visits at     1 month, 3 and 6 months.   "
108012|NCT01872221|"     This is a prospective biomedical study of interventional type which includes 16 patients on     52 months (24 months of inclusion and 28 months of follow up).      This pilot study, combining a metabolic imaging approach (Proton Magnetic Resonance     Spectroscopy = 1HMRSI) and a biological one, will be performed in patients harbouring a     Glioblastoma (GBM)to determine whether MRI markers of aggressiveness (CNI2) are associated     with specific biological patterns as regards to GBMSC (GBM contains tumor stem cell).      In the first part of the study, patients with radiological criteria of GBM amenable to     surgical resection will be included ; pre-operative multimodal MRI scans will be done and all     data acquired (including H1MRS and DTI data) will be integrated in the image-guided surgical     device (ie neuronavigation system) to be used intraoperatively. During tumor resection,     tissue samples will be individualized, based on their multimodal imaging characteristics and     sent to the radiobiology laboratory INSERM for biological analysis.      After surgery, patient will be treated by the standard radio-chemotherapy stupp protocol and     will be followed according to standard practices; multimodal MRI will be performed every 2     months during the first year and then every 3 months until progression.   "
108013|NCT01872208|"     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the     creation of an above-knee femoro-popliteal bypass graft in patients with peripheral arterial     disease.   "
108014|NCT01872195|"     This project aims to produce a systematic review on present knowledge on effects of using     safety checklists in medicine. Implementation of a checklist system throughout surgical care     may reduce patient morbidity and mortality. The reliability of patient data is crucial to     make firm conclusions as to such effects. This project aims to investigate if such morbidity     and mortality effects are obtainable in two Norwegian hospitals while at the same time making     a crucial evaluation of the patient data used in this study itself.      We hypothesise        1. An updated systematic review of the research literature provide evidence that safety          checklists use does enhance safety and reduces patient mortality and morbidity        2. Implementation of the patient safety checklist system will reduce patient mortality and          morbidity in the checklist cohort, and subsequent effects on length of stay        3. The sensitivity and specificity of ICD-10 coding vs. medical journal information is          poor, with study results to be adjusted accordingly.   "
108015|NCT01872182|"     The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in     patients with abdominal obesity of metabolic syndrome.   "
108016|NCT01872169|"     Gastroenterological disorders are disorders affecting the stomach, intestines and associated     organs. Symptoms of these types of disorders vary but often include vomiting, diarrhoea,     weight loss and loss of appetite. Due to the nature and symptomatology of these disorders     research has suggested that sufferers may be vulnerable to developing disordered eating     behaviours. Treatment of such disorders often requires dietary restriction which has been     found to lead to an obsessive preoccupation with food and in some cases to an increase in     binge eating. Further to this, symptoms of Gastroenterological disorders such as vomiting     have also been suggested to be linked with disordered eating. At the present there is limited     research in this area and as such evidence is inconclusive. Particularly little research has     looked at this area in relation to adolescents, who have been recognised as being at     increased risk for the development of disordered eating . Gastroenterological disorders are     likely to affect the typical development of eating habits and therefore it seems plausible     they may also predispose adolescents to developing abnormal eating behaviours /weight     concerns.      The aim of this study is to further investigate the possibility that Gastroenterological     disorders may be a risk factor for disordered eating in children and adolescents. This study     will recruit children/ adolescents aged 5-17 and their parents, who are attending Great     Ormond Street Gastroenterology Clinic and ask them to complete a screening questionnaire. The     recruitment process will be on going for around 5 months until the study has around 300     participants. Following this initial questionnaire, participants who are categorised as     screening positively for disordered eating and a 10% sample of participants that screen     negatively, will be contacted to complete a further questionnaire interview that will look     more specifically into this area.   "
108017|NCT01872156|"     The purpose of this study is to evaluate the effectiveness of the behavior treatment     accompanied by self-help materials in Primary health care, across the intervention of the     midwifes in the pregnancy follow-up visits.   "
108020|NCT01872117|"     The deep heat therapies are increasingly frequent in daily physical therapist for the     treatment of musculoskeletal diseases. The use of such procedures is justified by their     analgesic, anti-inflammatory, antiespasmolíticos and hiperemiantes. However, studies on the     cardiovascular effects of these therapies are still incipient. Therefore, this study has as     objectives: map the skin temperature changes in the lower limbs in different areas and     positions after applying shortwave diathermy and microwave; assess hemodynamic and autonomic     cardiovascular parameters, and investigate the occurrence of changes in conduction velocity     superficial blood resulting from the application of these thermal features. The study will be     conducted on 40 female volunteers between 18 and 30 years, university, healthy, that fit the     inclusion and exclusion criteria of the study. The analysis by infrared thermography will be     held in a room with temperature maintained at 23 ± 1°C and humidity average 50%. The     volunteers will stay in prone position, with the legs bare, resting for 20 min to stabilize     skin temperature with temperature of the room. After this period will be held applying     diathermy of shortwave or microwave for 20 minutes at moderate heat on the lower limb regions     of the hamstrings and triceps surae in extension and flexion to 180° to 90°. The records beat     to beat blood pressure and heart rate to autonomic and cardiovascular hemodynamic evaluation     will be performed by means of equipment Finometer (Finapress Medical Systems, Inc.) and     electrocardiogram (ADInstruments, Inc.), respectively, before and after application of     diathermy. On the other hand, the images will be processed using FLIR ThermoScan and blood     flow data will be collected through the Doppler ultrasound. The results will be processed and     analyzed using descriptive statistics, submitted to a linear regression model with mixed     effects (random effects and fixed), with p≤0.05.   "
108021|NCT01872104|"     This research is a prospective randomized controlled trial.It aimed to determine longterm     outcomes and factors associated with increased survival after photodynamic therapy (PDT)     through colonscopy compared with chemotherapy alone in patients presenting with advanced     rectal cancer.   "
108022|NCT01872091|"     Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature     and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries     and veins resulting in decreased blood flow.   "
108023|NCT01872078|"     To assess the effects of AZD4901 when given in multiple doses to females with Polycystic     Ovary Syndrome   "
108024|NCT01872065|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     ARC-520 in normal, adult volunteers.   "
108025|NCT01872052|"     Study to determine the feasibility of the Acutus Medical System in obtaining data to create     Dipole Density Maps of electrical activation in the right atrium in patients with typical     atrial flutter.   "
108026|NCT01872039|"     To compare the efficacy and safety of two dose adjustment regimens (i.e. weight-based and     non-weight-based) for the treatment of Chinese hypertensive emergency patients.   "
108027|NCT01872026|"     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics     of ASP7991 after oral administration to patients with chronic kidney disease undergoing     hemodialysis.   "
108028|NCT01872013|"     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics     of ASP7991 after multiple oral administrations to non-elderly subjects.   "
108029|NCT01872000|"     Following cataract surgery, an intraocular lens (IOL) is implanted in the eye. The majority     of people develop an operable cataract when they are over the age of 50. Occasionally people     under 50 years develop a cataract requiring an operation. The visual demands in this age     group are very different due to both physiological and lifestyle factors. Traditionally IOLs     are focussed for distance vision and additional spectacles are worn for near vision. Under     the age of 45 years we have the ability to naturally change the focus of our eyes and do not     require additional reading glasses. This is known as accommodation. By removing the     cataractous lens and replacing it with an IOL with a fixed single focus, both eyes work     together for distance vision but only the unoperated eye is able to change focus for     different working distances. This study aims to establish whether a multifocal IOL implanted     in one eye is able to complement the accommodation in the other eye so the 2 eyes work more     effectively together. This may enhance depth perception and improve the quality of vision.     Depth perception is important for more comfortable vision on the computer screen, when     reading and for jobs that require good depth perception.   "
108030|NCT01871987|"     A study to evaluate the effect of food on the plasma concentration changes of quetiapine     after oral administration of FK949E (extended release formulation of quetiapine) in healthy     male subjects.   "
108031|NCT01871974|"     The objective of the study was to evaluate the safety and plasma concentration changes of     quetiapine after multiple oral administration of FK949E (extended-release formulation of     quetiapine) in patients with major depressive disorder (MDD).   "
108032|NCT01871961|"     To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the     Metoject® prefilled pen (including a label comprehension assessment and a device robustness     evaluation).   "
108033|NCT01871948|"     Cancer patients often experience problems in their care, many of which are caused by     communication breakdowns. Some communication breakdowns lead to adverse events and even     harmful errors. Deficiencies in provider-patient communication can compound patients'     distress, lower the quality of care, and disrupt patient-provider relationships. There is     little research on patients' and providers' experiences of the communication breakdowns that     precipitate adverse events and errors, or on effective responses to these events. Because of     this, cancer providers are unsure how to communicate with patients in these difficult     situations. The goal of the proposed study is to improve patient-centered communication     around adverse events and errors in cancer care. Our specific aims are: 1) To describe     patients' experiences with communication around adverse events and errors in cancer care, 2)     To describe providers' experiences and practices with communication around adverse events and     errors in cancer care, 3) To develop practical recommendations, provider training materials     and patient educational materials for improving communication around adverse events and     errors in cancer care, 4) To disseminate the recommendations and materials through three     health plans, and 5) To conduct a preliminary evaluation of the perceived usefulness and     impact of the materials. The investigators will first conduct interviews with breast and     colorectal cancer patients who have experienced adverse events or errors at 3 Cancer Research     Network (CRN) health plans (Atlanta, Georgia; Seattle, Washington and Worcester,     Massachusetts). The interviews will focus on instances where patients believe that better     communication might have prevented an adverse event or error, or mitigated the event's     impact. Next the investigators will conduct focus groups to understand providers' attitudes     and experiences with these communication dilemmas, and use simulations to describe providers'     communication practices. Finally, the investigators will interview health plan leaders to     identify the systems factors that influence communication with patients around adverse events     and errors. These perspectives will be synthesized to create patient and provider educational     material for improving communication. Three advisory panels: a Patient Advisory Panel, a     Health Plan Advisory Panel and a Dissemination Advisory Panel (including all 14 CRN health     plans) will help create and disseminate these educational interventions. Dissemination will     occur at the three core clinical sites. The investigators use patient and provider surveys to     evaluate the educational materials' impact. This evaluation will provide the evidence-base to     refine the study products before widespread dissemination throughout the CRN and beyond. The     project will have the advantage of the CRN infrastructure, the CRN Clinical Communication     Research Center, and is led by nationally recognized communication researchers.   "
108040|NCT01871857|"     Research suggests that hypertonic saline may improve mucous flow in infants with acute     bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved     pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as     compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has     not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve     bronchiolitis severity scores and admission rate.   "
108034|NCT01871935|"     Induction of general anaesthesia with a combination of opiates and hypnotics often induces     vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure     (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize     tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators     group has revealed that atropine has an exceptionally beneficial effect on the determinants     of tissue oxygen delivery as well as on tissue oxygenation. The investigators have     demonstrated a significant and clinically relevant increase in CO and cerebral tissue     oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more     usual clinical practice of administrating classical vasoactive medication such as     phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and     SctO2. In previous research the investigators used standardized target controlled     propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known     that remifentanil has more intense haemodynamic side-effects compared to other opiates such     as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect     of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid     during anaesthesia of propofol combined with other opiates such as sufentanil.      Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep     general anaesthesia, which is usually performed with the combination of drugs as mentioned     above. Because these patients often experience severe haemodynamic fluctuations they need to     be closely monitored.   "
108035|NCT01871922|"     Remifentanil is a widely used potent intravenous opioid with the advantage of having a short     time of action. Compared to other opiates however remifentanil generates more intense     hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges     necessitate the administration of a combination of relatively high doses of analgesics on the     one hand and a short time for postoperative recovery from anesthesia on the other. For these     reasons, anesthetic management often consists of a combination of relatively high doses of     propofol and remifentanil. A primary concern during this deep propofol/remifentanil     anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous     research of the investigators group has revealed that atropine has an exceptionally     beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the     investigators hypothesize that administration of intravenous atropine during induction of     propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral     and cerebral tissue oxygenation during and after induction of anesthesia.   "
108036|NCT01871909|"     Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans.     The investigators hypothesize that the physiologic changes that occur with application of     LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that     LBNP is a truly valid model of human hemorrhage.   "
108037|NCT01871896|"     Morbid obesity and its associated metabolic diseases are on the rise in the United States.     Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric     bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients     who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess     body weight loss or regain of weight. For those patients who fail to lose weight after     bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment     is re-operation and revision. Re-operation of the abdomen carries significant postoperative     morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic     suturing device that has already been approved by the FDA as an option for bariatric surgery     revision without having to re-operate on the patient. The investigators believe that the     endoscopic technique may be able to provide weight loss without having to re-operate on the     patient.   "
108038|NCT01871883|"     Sensitive skin syndrome is defined as the presence of burning, itching or any other     unpleasant sensation on the skin, due to physical, chemical or psychological factors. It is     frequently a self-diagnosed condition, and there are no accurate tests to recognize or     quantify it because of the individual variations in perception and intensity of the related     symptoms. The most accepted physiopathogenic theory is the presence of an altered barrier     function of epidermis. Also, changes in the pH of the stratum corneum have been found to     induce skin sensitivity through the activation of the transient potential receptor vanilloid     (TRPV) neuronal receptors.      TRPV1 has been found in human keratinocytes, although its physiologic role in the skin is not     yet established. Their presence in keratinocytes and cutaneous nervous fibers suggests a role     in the sensitive function of the epidermis. Since this receptors can be activated by low pH     (< 5.9), which is also important for the development of sensitive skin, we hypothesized that     an increase in the expression of these receptors can be the responsible for the syndrome.   "
108039|NCT01871870|"     The objectives of this outpatient research study are (1) to assess the ability of this     automated system to be operated by a subject with limited professional oversight; (2) to     assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump     controller) will reduce the frequency of hardware and data communication lapses seen in the     previous system; and (3) to measure the degree of glucose control achievable with this     automated system. The system will adjust blood glucose by administering insulin and glucagon.     Insulin is a hormone that lowers blood glucose and will be given nearly continuously during     this study. Glucagon raises blood glucose and will be automatically administered during     hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will     have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering     insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring     glucose. The two sensors will feed glucose data into Motorola smart phone master controller,     which will calculate the correct amount of insulin or glucagon to deliver. The system will     then send the command to the correct Omnipod through the iDex pod controller.      In this new system, the research subject will be able to monitor the progress of the study by     use of the smart phone graphical user interface. The subject will have a companion with     him/her during the entire study for safety purposes. Both the subject and companion will     complete a training course on how to treat diabetic emergencies and how to operate the     system. A study physician and technician will be in the hotel during each study and will be     monitoring the study via a cloud-based data communication system. These studies will be     carried out in a hotel setting.   "
108041|NCT01871844|"     This was a within group, randomised, repeated dose, placebo- and octreotide controlled study     in a target population of 45 healthy male subjects. Subjects were required to attend the     clinical for screening procedures between 3 and 28 days before dosing commenced. The study     was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised     design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9     subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow     for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group 4     (the active control group) was still to proceed if the decision was taken to prematurely stop     dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data     presented at the interim decision meeting; dosing of this group was conducted independently     from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of     investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were to     receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled to     receive their final dose of IMP on the morning of Day 7.      In addition, subjects were to receive exogenous test administrations(stimulation test) on Day     -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first dose     of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day). Blood     samples for PD and PK analyses were taken at specified time points after each dosing.      Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7)     providing that discharge conditions had been met, and returned to the clinic between 5 and 10     days after the last IMP administration for a follow-up visit.   "
108042|NCT01871831|"     Systems for blood glucose monitoring with glucose oxidase enzyme reaction on test strips can     be affected by the partial pressure of oxygen of the blood sample. In this study, we     investigate the influence of different partial pressure of oxygen in blood samples on     measurement results. Systems with labelled oxygen-dependency as well as systems without     labelled oxygen-dependency are evaluated.   "
108043|NCT01871818|"     The purpose of this study was to compare the effectiveness of two rehabilitation programs     (one month) in patients with multiple sclerosis. The first program is combined with     physiotherapy, endurance training and resistance training. The second one is physiotherapy in     private practice. Another purpose is to assess the length of the benefits of the combined     program.   "
108044|NCT01871805|"     This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of     CH5424802/RO5424802 in patients with ALK-rearranged non-small cell lung cancer who failed     crizotinib treatment. In Phase I, cohorts of patients will receive escalating doses of     CH5424802/RO5424802 orally twice daily. In Phase II, patients who failed crizotinib treatment     will receive the recommended phase II dose (600 mg) daily in two oral doses.   "
108045|NCT01871792|"     Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast     administration and is associated with increased short- and long-term mortality. Previous     strategies including forced diuresis with diuretics or mannitol, intravenous administration     of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN have been largely     unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has yielded conflicting     outcomes.      A review of a large insurance database and retrospective study have shown that statins     therapy is associated with a lower incidence of CIN after percutaneous coronary intervention.     The preventive effect of statins on CIN may be attributed to direct pleiotropic effects on     the vascular wall such as improvement of endothelial dysfunction, anti-inflammatory or     anti-oxidative effect. However, recent randomized trial could not demonstrate the preventive     effect of statin on CIN in patients with chronic kidney disease.      Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal     dysfunction undergoing coronary angiography or intervention.   "
108046|NCT01871779|"     Cardiovascular disease remain one of the leading causes of death in Australia, accounting for     47637 (36%) of deaths in 2004.      Peripheral arterial disease (PAD) is a category of cardiovascular disease, characterised by     intermittent claudication. This is defined as walking induced pain, cramping, aching,     tiredness or heaviness in one or both legs that does not go away with continued walking and     is relieved with rest. It is estimated that between 5-10% of individuals aged over 50 years     suffer from claudication. The primary and most effective treatment for these patients is     focused on improving walking ability and functional status.      Current research has shown that approximately 30% of patients improve with exercise, while     30% continue to deteriorate and the rest show no change. The changes produced at a     biochemical and cellular level due to exercise are unknown. To help better understand this,     our study will assess the entire range of proteins expressed before and after exercise in the     skeletal muscle tissue of patients with intermittent claudication. This will help to     identifying key proteins that have a role in improving patient symptoms and outcome.   "
108047|NCT01871766|"     This study will treat participants with newly diagnosed, low, intermediate and high risk     rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified     dose chemotherapy, radiation and surgical resection. Intermediate and high risk participants     will receive an additional 12 weeks (4 cycles) of maintenance therapy with anti-angiogenic     chemotherapy.      PRIMARY OBJECTIVE:        -  Estimate event-free survival for intermediate risk participants treated with          vincristine, dactinomycin and cyclophosphamide with the addition of maintenance          anti-angiogenic therapy.      SECONDARY OBJECTIVES:        -  Estimate the false negative rate and incidence of additional positive lymph nodes in          participants undergoing sentinel lymph node biopsy followed by limited nodal dissection.        -  Maintain a high local control rate in participants treated with surgery and/or limited          volume proton and photon radiation without dose escalation.        -  Define the incidence and type of failure in participants who receive risk-adapted local          therapy relative to the primary tumor volume.        -  Establish the feasibility of delivering 4 cycles of maintenance anti-angiogenic          chemotherapy in intermediate and high risk patients following standard chemotherapy.        -  Estimate the event free survival for high risk patients receiving interval dose          compressed therapy and maintenance anti-angiogenic therapy.        -  Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2          toxicities) related to proton beam therapy.   "
108048|NCT01871753|"     The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant     recipients with asymptomatic bacteriuria.   "
108053|NCT01871688|"     As cancer treatment improves, the cancer survivor's quality of life and level of function     have gained increasing importance. Pelvic floor function is directly affected by     gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a     patient's life. PFD negatively affects health-related quality of life (HRQOL). Evaluation of     PFD provides information about the disease burden and treatment-related effects directly from     the patient's perspective and informs clinical decision-making. The pelvic floor musculature     and sacral nerves are not easily accessible, and it is difficult to test them. Several     functional assessments have been used to evaluate pelvic floor dysfunction; however, reports     on methodology are sparse, and consensus on their use is lacking. Research on functional     outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.   "
108054|NCT01871675|"     The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and     preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine     plus rituximab, to subjects with select relapsed/refractory hematologic malignancies.   "
108055|NCT01871662|"     The purpose of this study is to explore whether silibinin plus ribavirin with/without     peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of     care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.   "
108056|NCT01871649|"     The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial     of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients     with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate     alone is started. Golimumab will be discontinued.      Hypotheses:      First, the investigators hypothesize that initiation of a combination therapy with golimumab     + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the     percentage of patients achieving Disease Activity Score (the investigators hypothesize that     more patients with the early combination treatment will respond (according to Disease     Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response     Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal     Disease Activity (MDA) than patients on MTX alone.      Third, the investigators hypothesize that a significant proportion of the patients will     continue to benefit from this early aggressive treatment initiation even after stopping     golimumab treatment.   "
108057|NCT01871636|"     Conventional techniques of endoscopic mucosal resection (EMR) by snare resection do usually     not achieve resection of gastrointestinal mucosal neoplastic lesions larger than 1 cm in     diameter in a single piece. Complete R0 resection cannot be histologically confirmed. In     contrast to EMR the technique of endoscopic submucosal dissection (ESD) allows en-bloc     resection even of large neoplastic lesions. The waterjet-assisted ESD technology (WESD)     allows pressure controlled injection of fluids through the tip of a recently developed     HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions as well     as coagulation of bleeding sources can be performed with the same device without need for     changing the instrument. Our group reported on effective en-bloc resection of esophageal     areas in all of 14 cases of an Erlangen porcine model. We subsequently compared WESD with EMR     of predefined esophageal mucosal lesions in anesthetizised pigs in a randomized controlled     trial. The results demonstrated that WESD more frequently achieved a complete resection with     a significantly lower number of specimen. WESD caused no perforations and bleedings could be     endoscopically managed during the procedure. In addition we recently reported on this     technology in a first clinical trial on WESD for early Barrett`s neoplasia . The results     indicated that WESD can be safely and effectively performed in the esophagus.      Therefore the primary objective of this study is to compare the R0 resection rate of ESD and     EMR for visible lesions of HIgh grade intraepithelial neoplasia (HGIN) or esophageal     adenocarcinoma (EAC). Secondary objectives are related to completeness of resection, safety     of the procedures, the medium term outcome and comparison of costs.   "
108058|NCT01871623|"     Le Fort I osteotomy is often used in orthognathic surgery for patients to solve midface     retrusion. It is known that post-surgical stability of Le Fort I osteotomy can be influenced     by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. In     patients with cleft lip and palate, the postoperative instability of Le Fort I osteotomy can     be even worse due to scar tissue resulted from palate surgery. Segmental LeFort I osteotomy     is another useful surgical modifications that can be easily done through the alveolar cleft.     It is performed to allow the correction of differences in the occlusal planes, correction of     transverse discrepancy or to facilitate an optimal occlusion. The most important benefits is     that the alveolar cleft in patients who have not had alveolar bone graft surgery or failed to     have successful result can be narrow down or even closed by approximation of two separating     alveolar segments. However, there are limited previous studies comparing the stability of     segmental versus one-piece Le Fort I osteotomy especially in patients with cleft. It is our     aim to investigate whether one-piece Le Fort I osteotomy or segmental Le Fort I osteotomy can     provide a better stability after surgery.   "
108059|NCT01871610|"     There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago     and GCS=13-15 will be recruited. Another group of 200 participants with the same age and     gender and without TBI will be recruited as the controls. All of them will undergo AD8     questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be     tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2.     10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for     AV45 amylid PET study.      There will also be 10 participants without traumatic brain injury and interested in this     study, aged 55 years or older better.   "
108060|NCT01871597|"     Video assisted thoracoscopic surgery (VATS) anatomical lung resections (lobectomy or     pneumonectomy) provide an effective minimally invasive treatment for stage 1 lung cancer.      Currently, a minority of anatomical pulmonary resections are being performed by VATS (15%)     (6). The technical difficulty and danger of VATS lobectomy is related to pulmonary arterial     branch manipulation and this is the main limitation of many thoracic surgeons regarding the     adoption of VATS lobectomy. We believe that if we can decrease the manipulation required by     the surgeon on the pulmonary arterial branch, we can make these procedures safe and therefore     more prevalent for anatomical pulmonary resections.   "
139001|NCT01465308|"     The purpose of this study is to determine whether the use of pure honey will help in the     treatment of radiation induced xerostomia and oral mucositis (symptom management)   "
108062|NCT01871571|"     This phase II trial studies how well bevacizumab, fluorouracil, leucovorin calcium, and     oxaliplatin before surgery works in treating patients with stage II-III rectal cancer.     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Drugs used in chemotherapy, such as fluorouracil,     leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab     together with fluorouracil, leucovorin calcium, and oxaliplatin may be an effective treatment     for rectal cancer.   "
108063|NCT01871558|"     To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus     SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.   "
108064|NCT01871545|"     The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States.     Although imaging plays a major role in HCC screening and staging, the possibility of     predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet     needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate     the use of new imaging criteria beyond size. The investigators would like to develop and     validate non-invasive magnetic resonance imaging (MRI) methods based on advanced     diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI     and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive     markers of major histopathologic features of HCC, and to predict and assess early response of     HCC to systemic therapy. The investigators also would like to develop quality control tools     to improve the quality and decrease variability of quantitative MRI metrics. These techniques     combined could represent non-invasive correlates of histologic findings in HCC, could enable     individualized therapy, and provide prognosis in patients with HCC.   "
108065|NCT01871532|"     This is a prospective, multicenter, open-label, comparative and parallel-group study of     ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH)     treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2     anovulatory subjects who have previously failed to conceive with clomifene treatment.   "
108066|NCT01871519|"     The study objective is to collect and report 12-month outcomes pertaining to activities of     daily living, quality of life, and safety parameters in a Medicare population to be treated     with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression     fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to     show statistically significant improvement from baseline in the four co-primary endpoints     (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if     the primary objective is met. New radiographic fractures, non-surgical management received,     VCF-related healthcare resource utilization, and vertebral body height restoration data will     also be collected.   "
108067|NCT01871506|"     There are currently over 11 million cancer survivors in the U.S. and survival rates are     increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of     diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial     vulnerabilities. Documented risks associated with continued smoking following cancer     diagnosis include decreased survival time; increased complications from surgery, radiation,     and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health &     Human Services Public Health Service evidence-based tobacco treatment guidelines exist but     have not been integrated into the cancer setting. This is a tremendous missed opportunity to     address a modifiable risk factor. In recognition of this treatment gap, the National Cancer     Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and     capacity for delivery of tobacco treatment in Cancer Centers. The American Society of     Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by     their second oncology visit as a core quality indicator; however, currently only half of     patients report being asked about tobacco use.      Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two     strategies to promote smoking cessation in suspected or newly diagnosed cancer patients.      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll     295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast,     genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be     randomly assigned to receive Intensive Counseling (IC) or Standard Care (SC). Both groups     will receive an initial motivational counseling session and 3 weekly follow-up counseling     sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm     has the option to also receive:        -  Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation          medication (Varenicline, bupropion, or combination NRT) at no cost to the participant.        -  Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling          sessions with a tobacco treatment counselor (total of 11 counseling contacts).      All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months.     Self-reported abstinence will be biochemically confirmed at 3 and 6 months.   "
108068|NCT01871493|"     The main purpose of this study is to evaluate how the body absorbs and removes LY2605541,     insulin lispro, and a mixture of both from the blood. The study has two parts. Participants     may enroll in only one part. Each part has four treatment periods in a fixed order. The study     will last approximately 8 weeks, not including screening. Screening is required within 28     days prior to the start of the study.   "
108069|NCT01871480|"     Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises     about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and     adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment     as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to     further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy     with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a     better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion     plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.   "
108070|NCT01871467|"     Previous studies have demonstrated a deficiency of blood dendritic cells in patients with     kidney disease that is associated with the development of viral infections after kidney     transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell     levels in patients with kidney disease in the hopes of developing new therapies to prevent     viral infections after kidney transplantation.   "
108071|NCT01871454|"     The objective of this prospective phase II protocol is to assess the toxicity and efficacy of     pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers   "
108295|NCT01868516|"     Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate     with or without incontinence (leaking). The purpose of this study is to test whether     dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of     OAB.   "
139361|NCT01460550|"     The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient     with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal     reconstruction.   "
108072|NCT01871441|"     This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant     works in treating patients with hematologic malignancies. Giving chemotherapy and total-body     irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may     also stop the patient's immune system from rejecting the donor's stem cells. Giving an     infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune     cells and help destroy any remaining cancer cells. When the stem cells from a related donor,     that closely matches the patient's blood, are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.   "
108073|NCT01871428|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes     mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to     receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.   "
108074|NCT01871415|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy, safety and tolerability of aleglitazar in combination with metformin in patients     with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy.     Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for     26 weeks in combination with their pre-existing metformin regimen and dose.   "
108075|NCT01871402|"     This Phase 3 study has been designed to determine and compare the efficacy and safety of     000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque     psoriasis.   "
108076|NCT01871389|"     Vitamin D deficiency is common after bariatric surgery. This study is designed to determine     if a high dose monthly supplement of vitamin D 3 will be effective in helping improve vitamin     D status after surgery such as gastric bypass. Bariatric surgery subjects taking monthly high     dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a     significant rise in serum vitamin D levels compared to the subjects taking only the usual     vitamin D protocol.   "
108077|NCT01871376|"     To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of     PCV   "
108078|NCT01871363|"     Pathological complete response, (pCR) correlates with a favourable overall prognosis in     locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a     pCR might be beneficial. The aim of the study is to investigate safety and efficacy of     preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is     pathological complete remission rate.   "
108079|NCT01871350|"     Weight loss and muscle wasting commonly occurs in patients with cancer, negatively     influencing their quality of life, treatment response and survival. Weight loss has been     reported as a side effect of chemotherapy treatment in cancer. Weight changes may be the     consequence of energy imbalance and disturbances in protein metabolism (through different     factors linked with chemotherapy), such as reduced caloric and protein intake (partly related     to depression), poor treatment tolerance, hormonal alterations, systemic inflammation etc.     This results in body composition modiﬁcations in favor of fat gain and/or lean body mass loss     in early stage cancer and loss of both fat mass and lean mass in advanced cancer. Depletion     of lean tissue in cancer patients is related to short survival, and decreased skeletal muscle     mass and function may result in fatigue and inactivity, which contributes to fat mass changes     and can be responsible for chemo-toxicity and increased mortality.      Gains in muscle mass are difficult to achieve in cancer unless specific metabolic     abnormalities are targeted. Recently, the investigators observed that essential amino acid     mixtures (EAA) are able to induce protein anabolism in patients with stage III and IV     non-small cell lung cancer. Previous experimental research and clinical studies in cachectic     conditions (including cancer) indicate that polyunsaturated fatty acids (PUFA) are able to     attenuate protein degradation by improving the anabolic response to feeding and by decreasing     the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic     acid (DHA)) has been shown to effectively inhibit weight loss in several disease states;     however, weight and muscle mass gain was not present or minimal. Recent studies examining the     effect of fish oil supplementation in relation to chemotherapy have been inconclusive but     found potential beneficial effects on physical performance and increased efficacy of     first-line chemotherapy in patients with non-small cell lung cancer.      It is the investigators' hypothesis that supplementation with milk protein (containing     essential amino acids) carbohydrate (CHO) mixture in combination with fish oil     supplementation will target the metabolic alterations in cancer patients receiving     chemotherapy, attenuating the negative effects of chemotherapy on gut function, muscle mass     and muscle function, and cognition; and leading to reduced toxicity from chemotherapy.   "
108080|NCT01871337|"     This study will examine whether the Paula method is an effective treatment for UI and the     correlating LUTD symptoms. We assume that the Paula method, a simple, non-aerobic exercise     method that significantly decreased urinary incontinence in women with MIX in two randomized     controlled trials, would also be effective in Multiple Sclerosis (MS) patients with UI. The     secondary aim is to evaluate the effectiveness in terms of MS general physical functioning,     quality of life and sexual function and to detect adherence and continuity six months post     intervention.   "
108081|NCT01871324|"     The purpose of this study is to compare the influence of an intervention program especially     designed to young ultra orthodox men that were diagnosed with diabetes type one.   "
108082|NCT01871311|"     The purpose of this study is to determine the recommended Phase II dose of nilotinib when     used in combination with cetuximab in the treatment of patients with recurrent and/or     metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.   "
108083|NCT01871298|"     The purpose of this exploratory study is to examine factors associated with frequency and     type of internet and mobile technology use among illegal drug users, specifically use of     internet and text-messaging to obtain health care information and engage in health care     utilization, specifically human immunodeficiency virus (HIV) prevention and treatment     services. We will target high drug activity neighborhoods in New York City and enroll     participants recruited through targeted street outreach. All participants (n=336) will     undergo an audio computer-assisted self-interview (ACASI) that will assess sociodemographics,     health care access and utilization, sex/drug use behavior, health status, and characteristics     of general and health-related internet/mobile technology use including factors that promote     or hinder use. Participants identified as using the internet ≥1/month (n=151) will return for     a 4-week ACASI to report on use of the pilot website (which will largely display information     currently available in the community in print/ pamphlet/ video form).   "
108084|NCT01871285|"     The primary aim of this study is to determine if chronic pain subjects on around-the-clock     opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely     transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose     without inducing opioid withdrawal or reversing analgesic effects.   "
108085|NCT01871272|"     PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus     surgery and identify factors associated with good and bad outcome after surgery.   "
108086|NCT01871259|"     To relate two different predictive values of sleep apnea: the STOP score (snoring while     sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the     estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during     propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under     spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a     STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade, tonsil     grade, and the body mass index. After performing spinal anaesthesia, propofol will be infused     and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal cannula,     will be then applied to estimate the level of apnea-hypopnea.   "
108087|NCT01871246|"     People with chronic obstructive pulmonary disease (COPD) are very sedentary and efforts to     establish an active lifestyle are challenging because of periodic acute exacerbations of COPD     that interrupt physical activity patterns and contribute to further decline in physical     activity. The purpose of this preliminary research is to learn more about the experience of     acute exacerbations of COPD (AECOPD) from the perspective of the patient and his/her family     and to learn how AECOPDs affect physical activity.   "
108088|NCT01871233|"     The Extended Access Program (EAP) is a managed access programme for Perampanel. The main     objective of this EAP is to ensure that patients participating in studies E2007-A001-207,     E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time     perampanel tablets become commercially available for the treatment of Partial Onset Seizures     (POS) in the country in which they reside. This EAP will consist of 2 phases:        -  Screening: The patient will start the program once the Screening assessments are          completed and the patient is qualified for participation.        -  Treatment: Additional assessments, physical examinations, and dosage changes will be          clinically determined by the treating physician.      Patients will enter this program on the same dose of perampanel that they were receiving at     the end of their participation in previous study. Doses of perampanel and of concomitant     anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based     on clinical judgment.      Treatment will be prescribed as long as clinically appropriate according to the judgement of     the treating physician and the approved Summary of Product Characteristics (SmPC).      The program will complete in a staggered fashion, country by country, as and when perampanel     becomes commercially available for the treatment of POS in each country.   "
108089|NCT01871220|"     The purpose of this study is to compare the effect of two different implant abutment designs     on gum tissue volume changes over time after implant placement.   "
108090|NCT01871207|"     Some studies have recently shown that the concentration of erythropoietin in the vitreous     humor of diabetic patients suffering from diabetic retinopathy is higher than non-diabetic     patients. It was reported a higher concentration of erythropoietin in vitreous humor than     blood, indicating a local production. In some cases it was also found a positive association     between concentrations of Erythropoietin and Vascular Endothelial Growth Factor (VEGF). Both     of these factors, erythropoietin and VEGF, show important angiogenic activity and may play a     role in the development of diabetic retinopathy.      This study enrolled type 2 diabetic patients with PDR who had to undergo vitrectomy during     the period May 2011-January 2012 at the Unit of Ophthalmology, A.O. Civil Hospital and     University of Brescia. Inclusion criteria were the following: type 2 diabetes, age greater     than 18 years, and PDR; exclusion criteria were: age less than 18 years, type 1 diabetes,     initial DR, PDR patients not requiring surgery, previous vitrectomy in the eye under     examination or other ophthalmic surgery or laser therapy within the previous 3 months.      Non-diabetic patients who underwent vitrectomy for macular hole or pucker represented the     control group (CTRLs); their inclusion criteria were: age greater than 18 years and the     presence of macular pucker or macular hole requiring vitrectomy. Exclusion criteria were: age     less than 18 years, diagnosis of diabetes mellitus, and previous vitrectomy in the eye under     examination or other ophthalmic surgery or laser therapy within the previous 3 months. All     patients underwent a complete ophthalmologic examination (visual acuity, slit lamp,     tonometry, fluorescein retinal angiography, and optical coherence tomography -OCT-). Informed     consent was obtained from all patients after a detailed description of the aims and     procedures of the study.      The following data were recorded for each patient:        1. Population: age (years), sex (M/F);        2. Clinical: diabetes (Absent or Type 2); time since initial diagnosis of diabetes (years);          type of therapy for DM: diet, oral hypoglycaemic agents, mixed (oral agents and insulin,          insulin); hypertension (defined as systolic blood pressure > 140 and diastolic blood          pressure > 90 mmHg or on antihypertensive drugs); current (Yes/No) antihypertensive          therapy; use of angiotensin II receptor blockers (ARB) or angiotensin converting enzyme          inhibitors (ACE-i); presence of hypercholesterolaemia, comorbidities, therapy with          statins (Yes/No), anticoagulants (Yes/No), antiplatelet therapy (Yes/No); other          therapies performed, smoking (non-smoker, active smoker); complications of diabetes          mellitus present at the time of evaluation (heart disease, nephropathy, neuropathy);        3. Ocular: eye (OD/OS); visual acuity; presence and grade of diabetic retinopathy; presence          of emovitreo; presence of diabetic macular oedema; presence of cataract or lens implant;          intervention with phacoemulsification during vitrectomy; presence of retinal diseases,          or any other concomitant eye diseases; performance of previous retinal laser therapy,          intravitreal injection of Avastin before the vitrectomy;        4. Biochemical: Haemoglobin (g/dL); glucose (mg/dL); glycated haemoglobin (%); platelets          (N/mmc); creatinine (mg/dL); albuminuria (mg/day), creatinine clearance (mL/min),          calculated by the Modification of Diet in Renal Disease (MDRD) formula; total          cholesterol (mg/dL); HDL and LDL; triglycerides (mg/dL).      All patients underwent a 23- or 25-gauge pars plana vitrectomy. The primary outcome of the     study was the measurement of EPO and VEGF concentrations in serum and vitreous and aqueous     humor. Blood samples, taken before surgery, were centrifuged at 3000 rpm for 10 minutes to     separate the serum fraction, which was stored at -80°C. Aqueous and vitreous humor were taken     during the surgery and immediately frozen at -80°C. Both EPO and VEGF concentrations were     measured in serum and vitreous humor; however, owing to the small amount of sample, only EPO     concentrations were determined in aqueous humor. EPO was assayed by radioimmunoassay     (Immulite EPO 200, Siemens), with the lowest detection limit of 1.0 mIU/mL. VEGF was assayed     by ELISA (Human VEGF Immunoassay, R & D Systems Europe, Abingdon, UK) with a lower limit of     detection of 10.0 pg/mL. VEGF concentrations below the lower limit of detection were set to 5     pg/mL to perform statistical analysis. VEGF values above 2000 pg/mL were set to 2500 pg/mL;     statistical tests were also performed after deleting the data above 2000 pg/mL.   "
108091|NCT01871194|"     This study aims to evaluate the use of rivaroxaban and its short term safety when used by     patients for the new indications of prevention of stroke and systemic embolism in patients     with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary     embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care     team on rivaroxaban or an alternative anticoagulant for the specified indications during the     study period will be eligible to take part. A questionnaire will be completed by the care     team of each patient at the start of treatment and again 12 weeks later. The care team will     complete the questionnaires using information from the patient's medical notes, not by asking     the patient directly. If a participant has an adverse event during the 12 week period, we may     ask the patient's care team to fill out a further follow up questionnaire. No other     examinations or tests will be performed. Patients will only be recruited to the study after     the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made,     so that prescribing behaviour is not altered by the study. It is an observational,     non-interventional study covering the whole of England and Wales.   "
108092|NCT01871181|"     Injection of local anesthetic drugs is an effective way to freeze (block) nerves to achieve     loss of sensation during surgery and satisfactory pain control afterwards. Many studies have     shown that nerve block is associated with higher degree of success in controlling pain after     open inguinal hernia repair. Nerve block can be administered by a single injection with a     long acting local anesthetic agent using ultrasound guidance. This study is to compare     different techniques for freezing the nerves responsible for pain after open inguinal hernia     repair. Patients will be randomized to one of two groups. In the first group, participants     will receive ultrasound-guided nerve block following induction of general anesthesia but     prior to surgical procedure. In the second group, participants will receive local anesthetic     injection directly into the wound by the surgeon prior to closure. The investigators will     assess the level of pain control for 48 hours after the surgical procedure. Patients will be     provided with additional medications for pain relief if necessary. The investigators will     also contact participants to follow-up with regard to possible chronic groin pain after 3     months following the surgical procedure.   "
108093|NCT01871168|"     The purpose of this study is to establish an alternative method of postoperative pain control     to the current standard of practice, patient-controlled analgesia with intravenous opioids,     for patients undergoing a major major abdominal surgery at the University of Alberta     Hospital. The primary objective is to determine whether a continuous transversus abdominis     plane (TAP) block, run until the third postoperative day, will reduce the amount of     intravenous morphine required. Additionally, the investigators propose to measure the amount     of local anesthetic (lidocaine) in the blood during this time frame to provide patient safety     data for this procedure. This will be a prospective controlled randomized double-blind     clinical trial. The patients, anesthesiologists and staff providing post operative care will     be blinded to group assignment. Patients will be randomized by sealed envelopes.   "
108094|NCT01871155|"     The purpose of this study is to determine whether a novel edible nutritious gel for patients     with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality     of life of head and neck cancer patients while undergoing conventional radiotherapy.   "
108296|NCT01868503|"     This phase II trial studies how well lapatinib ditosylate and radiation therapy work in     treating patients with locally advanced or locally recurrent breast cancer. Lapatinib     ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib     ditosylate together with radiation therapy may be an effective treatment for breast cancer.   "
108297|NCT01868490|"     Cytokine-induced killer (CIK) cells exhibit high proliferation rate and cytotoxic activity in     vitro. The major effector cells are the CD3+CD56+ subset. The cytolytic activity of CIK cells     being independent of MHC restriction implies feasibility in using CIK cells allogeneic to the     tumors. Experiments to block the MHC class-I and -II pathways on tumors-RNA transfected DCs     showed that only MHC class-I blocking led to a significant reduction of heterogeneous CIK     cells cytotoxicity after the co-culture. The safety of CIK cells was demonstrated by the lack     of cytotoxicity toward autologous as well as allogeneic normal cells. Co-culture of CIK cells     with dendritic cells (DCs) has been reported by us and others in a myriad of cancer (e.g.,     cholangiocarcinoma, osteosarcoma, glioblastoma multiforme, multiple myeloma, hepatocellular     carcinoma, pancreatic carcinoma, renal & colon carcinoma, murine leukemia & lymphoma showing     enhancement of anti-tumor cytotoxicity of CIK cell in all. The co-culture of CIK cells with     DCs were reported to decrease the number of professional regulatory/ suppressor T cells     (Treg, CD4+CD25+ cells) and decrease the secretion of IL-10, an immune suppressor cytokine,     whereas the cytotoxic activity against target cells increased.      We have recently brought CIK cells through the preclinical phase (animal study) of human     cholangiocarcinoma treatment. Cholangiocarcinoma (CCA), is a bile duct epithelial cancer     endemic in the Northeast of Thailand, with an increasing incidence discernible in Europe and     North America. Conventional treatments including surgery, chemotherapy, and radiation do not     bring satisfactory survival due to anatomic location, presence of metastases, and high     recurrent rates. These unsatisfactory outcomes urge to search innovative treatments such as     immunotherapy. We reported the safety and efficacy of CIK cells in SCID mice model for     cholangiocarcinoma. Several conditions of human CIK cells were examined using ex vivo     cytotoxic assay and SCID mice pre-inoculated with human cholangiocarcinoma cells. We     monitored the ex vivo cytotoxicity, tumor sizes and immunohistochemistry. Optimal tumor     suppression was observed when CIK cells were pre-exposed to dendritic cells (DCs).     Tumor-infiltrating human CD3+ cells were observed from day 2 - 14, but not in normal tissues     elsewhere. These altogether indicated the specific homing of CIK cells to tumor mass. All     animals did not exhibit any noticeable adverse reaction from the CIK treatments. The     CD3+CD56+ cells are logical candidates for clinical trial while the DC-co-cultured CIK cells     produced similar efficacy and more feasible for clinical application.      With a complete array of in vitro and in vivo study, the next rational step is moving forward     to phase I/II clinical trials for a number of specified solid tumors (i.e.,     cholangiocarcinoma, osteosarcoma, and glioblastoma multiforme, nueroblastoma) using the     optimized autologous CIK cells. Subjects without prior exposure to or weaned for at least 3     months from chemotherapy can be recruited to maintain the integrity of their immunological     system, a critical factor for a successful immunotherapy.   "
108095|NCT01871142|"     In low oxygen environments, such as high-altitude, some adults may become ill and suffer from     acute mountain sickness. Further, all adults will find that exercising becomes much more     difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of     this investigation is to study the effects of a new medicine called Aes-103. A company called     AesRx, LLC makes this medicine. The active ingredient in the medicine is     5-Hydroxymethyl-2-Furfural (5HMF), a naturally occurring substance that can be found in     coffee, honey, dried fruits, fruit juices, malt, barley, Balsamic vinegar and caramel.The     investigators believe that Aes-103 may help people adjust to high-altitude quickly and     prevent them from becoming ill. The purpose of the study is to determine if Aes-103 will     promote endurance performance in low oxygen environments in healthy adult humans.      Aes-103 is currently being investigated by AesRx, LLC (Newton, MA) in collaboration with the     National Heart, Lung and Blood Institute of the NIH (Bethesda, MD) as a potential     anti-sickling agent in sickle cell disease. Sickle-cell disease is characterized by problems     in blood that prevent blood cells from carrying oxygen. Aes-103 might be able to help blood     cells carry more oxygen. It is for this reason that the investigators in this study believe     Aes-103 might help people adjust to high-altitude quickly.      There are no known special safety considerations with the active ingredient in Aes-103     (5-HMF). In recent, placebo controlled, clinical safety tests, Aes-103 was given in single     doses of 300 mg, 1000 mg,2000 mg and 4000 mg to healthy normal volunteers. Additionally, the     toxicological effects of Aes-103 have been studied when given acutely, sub-acutely, and     chronically in rodents, and for up to 28 days in dogs. Based on these safety studies, single     doses of Aes-103 are expected to have no significant negative/toxicological effect at the     doses being evaluated in this study.   "
108096|NCT01871129|"     The postoperative removal of intubation tube induces a noticeable sympathic response and     increase of blood pressure. The risk of complications is especially elevated with the     patients having cardiac surgery. Though sedation inhibits the sympathetic responses to     extubation, according to the current protocol the propofol infusion has to be discontinued     well before extubation because of its inhibitory effects on breathing centers.      Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its     characteristic that it does not have the paralyzing effect on breathing. The aim of our study     is to work out whether dexmedetomidine-extended propofol sedation over the extubation     diminishes the aforementioned harmful effects of the extubation procedure.      Study design is prospective double-blinded randomized study. The investigators compare two     groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic     valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first     group receives dexmedetomidine infusion and the other receives placebo infusion after the end     of propofol infusion.      The specific goal of the study is to figure what haemodynamic - mostly blood pressure related     - changes can be observed when the postoperatively cut propofol infusion is continued with     dexmedetomidine over the extubation procedure.      Our hypothesis is that by using dexmedetomidine supplemented sedation the normally notifiable     peak in blood pressure may be avoided.      The study will be carried out completely in Cardiac ICU in Tampere University Hospital.   "
108097|NCT01871116|"     This research is being done to assess the effectiveness of a weight loss program in women     with early stage breast cancer whose body mass index (BMI) is in the overweight or obese     range (>25). Weight loss is beneficial in improving cardiovascular risk factors and overall     health, but may also decrease the chance of breast cancer coming back. A weight loss     counseling program was studied in a general population and was found to be effective to help     reduce weight over a 2 year period.      The main goal of this study is to determine if women with a recent diagnosis of early breast     cancer will also lose weight with this program. To better understand the effect that weight     loss has on women with breast cancer, we will compare the patterns in blood and breast tissue     samples (tissue biopsies will be optional), and questionnaires evaluating different aspects     of one's well-being, before and after a dietary intervention or no intervention.   "
108098|NCT01871103|"     Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a     reliable flap donor site in reconstructive hand surgery because of its similar quality to the     original. The dorsal homodigital island flap can be used as a reliable alternative for     reconstructing small to moderate defects of the fingers. In this retrospective study, the     investigators would evaluate the efficacy of the technique for tissue reconstruction in     different regions of the finger, with an emphasis on sensibility, pain and donor site     morbidity.   "
108099|NCT01871090|"     A prospective, post market, non-randomized study to evaluate the reduction in time to     interrogation for patients with St. Jude Medical remote care compatible devices interrogated     by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will     enroll up to 100 patients total.      Expected duration of the study is 6 months. Once enrolled the patient will participate in the     study for the duration of the Emergency Department stay, until discharged or admitted to the     hospital.   "
108100|NCT01871077|"     The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution     PRO-156 over the ocular surface of ophthalmologically healthy volunteers   "
108101|NCT01871064|"     This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios     at tracheal extubation when anesthesiologists have determined that full recovery of     neuromuscular function has occurred using standard clinical criteria for participants whose     non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase     inhibitor administered as per standard routine care.   "
108102|NCT01871051|"     This project was aimed to identify the risk factors associated with the occurrence of     respiratory complications in post anesthesia care unit. The primary outcome was the composite     measure of occurrence of complications in PACU. The components were apnea or hypopnea,     laryngospasm, bronchospasm and prolonged oxygen requirement.   "
108103|NCT01871038|"     To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted     at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and     the Medical University of South Carolina (MUSC) in Charleston, South Carolina.      Children born on or after April 1, 2006 presenting to CCHMC as an inpatient or for a     short-stay or Emergency Department (ED) visit with acute gastroenteritis (AGE) and/or fever     will be approached for enrollment. Children will be eligible if they have vomiting and/or     diarrhea less than or equal to 10 days duration. Data including demographic information,     illness characteristics and socio-economic status will be collected from each patient. A     sample of the patient's stool will be collected within 14 days of the onset of symptoms.     Stool specimens will be tested for rotavirus antigen by Rotaclone at CCHMC. All rotavirus     positive stool specimens will be typed for common G and P serotypes. Using the children     identified with rotavirus as our cases and the children who were rotavirus negative as our     controls, we will conduct a case control study to assess the effectiveness of rotavirus     vaccines, in particular Rotarix.   "
108104|NCT01871025|"     To study the effects of early exercise training in hospitalized patients for Chronic     Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one     group, early exercise training (aerobic and strength) during hospitalization for COPD     exacerbation followed by exercise training at home until 90 days to discharge and in the     other the intervention is usual care. In both group, usual respiratory physiotherapy     techniques during hospitalization and adequate physical activity recommendations have been     included. The main variable is the presence of a new COPD exacerbation according to Global     Initiative for COPD (GOLD guidelines) with a minimum of 12 months-follow up.   "
108105|NCT01871012|"     Total Knee Replacement (TKR) performed under general anesthesia is a common successful     orthopedic procedure. Nonetheless, in elder patients with diabetes mellitus (DM) this     procedure can present unique challenges to orthopedic surgeon and anesthesiologist alike.     Many diabetic patients have clinical or subclinical neuropathy. Although there is no evidence     that the neuropathy is exacerbated by neural blockade, recent studies have suggested that the     peripheral nerves in diabetic patients may be more susceptible to trauma and local     anaesthetic toxicity. Therefore, The investigators observe peripheral nerve blocks with     ropivacaine on diabetic patients or non-diabetic patients undergoing TKR by assessing the     management of intraoperation and the Postoperative Recovery and complications.   "
108106|NCT01870999|"     This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of     aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with     schizophrenia.   "
108107|NCT01870986|"     This healthy volunteers study will evaluate 210 subjects who will receive a single     sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European     Union). This study will involve sampling and pharmacokinetics evaluation of drug levels     following administration of PF-06410293 and the licensed adalimumab products.   "
108108|NCT01870973|"     The purpose of this study is to evaluate patients with emergency pain and a sore (infected)     tooth to determine if immediate root canal therapy is better at reducing pain, when compared     to initial treatment with antibiotic and pain medication followed by root canal therapy. Each     participant will be randomly assigned a number, which will determine if they will receive     initial endodontic treatment that day or at a later date. Each participant will receive an     anesthetic injection, pain medication and a prescription for an antibiotic. They will be     asked to keep a diary to record their pain level after the injection and their pain levels     and the amount and type of pain medication taken each day for the next 5 days. Participants     who did not receive root canal therapy at the initial appointment will receive it after the 5     day postoperative period. The pain levels and medication use will be compared between the     treatment and nontreatment groups.   "
108109|NCT01870960|"     The main problem of using xenogenic bone in sinus floor elevation is the slow rate of     absorption, which gives the percentages of vital bone low (20 to 30% depending on the study)     in which the dental implant will be positioned However, osseointegration of the implant can     be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and     osteogenic properties known, could promote bone healing during surgery sinus floor elevation     by increasing the percentage of vital bone reformed, when added to xenografts.   "
108110|NCT01870947|"     This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and     DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive,     supervised assisted exercise program on a stationary bike improves quality of life, increases     motivation to continue to exercise, improves dietary behavior and leads to sustained weight     loss in women who have had early-stage endometrial cancer. Questionnaires will be used to     assess exercise motivation and dietary behavior. Brain's responses to different visual images     will also be assessed.   "
108111|NCT01870934|"     Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet     (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers;     approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer     treatment is extensive, resource demanding and highly specialized and necessitates     involvement of patient, hospital and local in-home care personnel.      The 3D photo optic camera project aims at a much more efficient and precise method for     diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for     LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera     that takes pictures and measurements of the ulcer that can provide the basis for correct     diagnosis and treatment of the ulcer. The camera was developed in close cooperation with     TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.   "
108112|NCT01870921|"     A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the     incidence of major cardiovascular events of ticagrelor in Chinese patients with acute     coronary syndrome   "
108113|NCT01870908|"     This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and     biological agents.   "
108114|NCT01870895|"     To demonstrate the superiority of YM060 to a placebo in global assessment of relief of     overall IBS symptoms and stool form normalization, and to evaluate safety in female patients     with diarrhea-predominant irritable bowel syndrome (D-IBS).   "
108115|NCT01870882|"     The purpose of this study is to determine the feasibility and preliminary efficacy of     attention training using a portable electronic device for opioid-dependent cocaine-users     stabilized on methadone.   "
108116|NCT01870856|"     The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper     epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of     that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the     ocular surface during blinking.   "
108117|NCT01870843|"     The purpose of this study is to evaluate the impact of escitalopram on quality of life and     social functionality in patients with major depressive disorder with anxiety symptom.   "
108118|NCT01870830|"     The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients     with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate     altitude.   "
108328|NCT01868087|"     The purpose of this study is determine if using Impact Advanced Recovery® before and after RC     surgery helps reduce surgical complications.   "
108119|NCT01870817|"     After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely     fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in     hospital. Current practice is to stop feeding once the patient leaves hospital, although the     tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have     to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed     restarted because of nutritional problems and this requires a further inpatient stay.      It is unknown whether every patient would benefit from this type of feeding at home. Previous     studies have only assessed the value of JEJ feeding while patients are still in hospital.     There is little known about the benefit of continuing JEJ feeding after discharge from     hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).      The proposed study will provide initial information on patients' well being by measuring     quality of life and factors such as change in body weight and dietary intake following a     period of home JEJ feeding after surgery. Subjects recruited into the study will be placed,     randomly, into a control group who receive current nutritional care (based on dietary advice     and oral nutritional supplement drinks) or an intervention group who will receive home JEJ     feeding for 6 weeks after hospital discharge, in addition to current treatment.      If subjects in the control group are experiencing problems eating at home, home feeding     through the JEJ tube will be started as needed.      The study will also examine how surgery and JEJ feeding at home impact on the patient and     carer(s) by means of questionnaires and interviews conducted in the patients' home.      Information obtained will assist in the design of a multicentre study. This intervention is     considered important because it has the potential to benefit thousands of patients each year     at a modest cost.   "
108120|NCT01870804|"     The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin     and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in     patients with non-ST-elevation acute coronary syndromes scheduled for early invasive     strategy.   "
108121|NCT01870791|"     The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately     16,000 patients in the United Kingdom die from the disease. In spite of new chemotherapy     regimens, the average survival for these patients is around 9 months from diagnosis.      Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish oil     supplementation can improve general well-being and quality of life in patients receiving     palliative chemotherapy for a number of different cancer types. It has also been suggested     that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy.      This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the     most widely used regimen for patients with advanced oesophago-gastric cancer, will make this     drug regimen more effective at killing oesophago-gastric cancer cells, such that disease     progression is delayed. Forty-five patients who have been diagnosed with advanced     oesophago-gastric cancer will be recruited over a two year period to receive standard     chemotherapy and omega-3 fish oil supplementation. The results in these 45 patients will be     compared to a matched historical control group of patients who have received identical     chemotherapy. If results suggest that the combination of EOX and Omegaven is sufficiently     effective, tolerable and feasible then it will be the intention of the trial team to take the     combination forward to treat patients with advanced oesophago-gastric cancer in a randomised     study.   "
108122|NCT01870778|"     The purpose of the study to evaluate the efficacy, safety and tolerability of intravenous     infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.   "
108123|NCT01870765|"     Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia.     Especially patients with acute or chronic pulmonary diseases are at risk of respiratory     failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be     performed safely using non-invasive ventilation. It seems probable that high-flow oxygen,     which is used in the treatment of patients with hypoxemic respiratory failure, is equally     effective in preventing the development of respiratory failure during fiberoptic bronchoscopy     while improving patient comfort. In this prospective randomised study the safety of high-flow     oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory     failure undergoing fiberoptic bronchoscopy.   "
108124|NCT01870752|"     Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility.     Ovarian tissue cryopreservation is an experimental strategy offered at The University of     Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this     study is to determine the efficacy and safety of autologous transplantation of previously     cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian     insufficiency after cancer treatments.   "
108125|NCT01870739|"     This was the first evaluation of the effects of LCZ696 on local and regional measures of     aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure.     The results of this exploratory study will help to understand the mechanism of action of     LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with     cardiovascular diseases.   "
108126|NCT01870726|"     The study will assess the safety and the dose of the combination of INC280 and buparlisib     (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent     glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In     addition, the anti-tumor activity of INC280 single agent will be assessed in patients with     recurrent glioblastoma with c-Met alteration.   "
108127|NCT01870713|"     The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery     which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard     remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes     mellitus patients in China.   "
108128|NCT01870700|"     A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in     adult patients with functional constipation.   "
108129|NCT01870687|"     The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg)     VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre     menstrual syndrome).   "
108130|NCT01870674|"     Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of     YH12852 after oral administration in healthy subjects   "
108131|NCT01870661|"     Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the     short axis technique. Our hypothesis is that long axis ultrasound placement will increase the     longevity of the IV catheter.   "
108132|NCT01870648|"     The primary objective is to determine if the administration of a single dose of oral     ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in     intravenous (IV) rehydration therapy in children presenting for emergency department care     with some dehydration, vomiting and diarrhea in Pakistan.      SOME Dehydration is defined as 2 or more of the following signs and symptoms:        -  Restlessness, irritability        -  Sunken Eyes        -  Drinks eagerly, thirsty        -  Skin pinch goes back slowly   "
108134|NCT01870622|"     Most premature babies have difficulty breathing at birth and need help (resuscitation). The     treatment for this is to gently inflate their lungs with a resuscitation device and a     facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in     the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical     team checks if the breathing tube is correctly placed within the windpipe. The investigators     routinely use a detector which checks for exhaled carbon dioxide or the graphical display of     waves forms of the infants breathing to check that the breathing tube position. However, the     investigators do not know which one (exhaled carbon dioxide or the graphical display of waves     forms) is better to check that the breathing tube position is correct and therefore the     investigators would like to study them. The purpose of this study is to compare exhaled     carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves     group) to provide us with information on how the investigators can help babies who struggle     with breathing at birth.   "
108135|NCT01870609|"     This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of     defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not     progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment     with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the     study, each subject must have tumor Merlin status(high or low) established by     immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1     ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be     stratified by tumor Merlin status (high versus low). Progression will be assessed both     locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST)     Version 1.1. Subjects will continue to receive treatment until disease progression or other     discontinuation criteria are met. Following documentation of nonfatal disease progression,     all subjects will be followed for overall survival by telephone contact every 2 months until     end of life or the close of the study.   "
108136|NCT01870596|"     This randomized phase II trial studies how well cytarabine with or without SCH 900776 works     in treating adult patients with relapsed acute myeloid leukemia. Drugs used in chemotherapy,     such as cytarabine, work in different ways to stop the growth of cancer cells, either by     killing the cells or stopping them from dividing. SCH 900776 may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     cytarabine is more effective with or without SCH 900776 in treating acute myeloid leukemia.   "
108137|NCT01870583|"     In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation     solutions for best outcome of surgical site infection. The three different solutions are:     Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin     preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based     skin preparation solutions. Women are prospectively randomized to one of the three groups and     followed until thier postpartum visit at 6-8 weeks following delivery.   "
108138|NCT01870570|"     The purpose of this study is to determine and compare the glycaemic index values and response     parameters of 6 food products between 3 laboratories.   "
108139|NCT01870557|"     Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers     and bone scans.      Methods:      This is a multicenter trial involving the University Hospitals of three major danish cities:     Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of     examinations including:        -  Blood samples to analyze bone markers, glycemic state, kidney function and sex-hormones.        -  24 hour urine sample to analyze bone markers and kidney function.        -  Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution          peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density,          t-score and bone structure.      Participants:      100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg,     Aarhus and Odense, general practitioners and flyers.   "
108140|NCT01870544|"     The purpose of the weight-loss study is to characterize the effect of LGG supplementation on     the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass     and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota     pattern and the degree of weight-loss post-surgery.      The investigators hypothesize that LGG administration will result in a leaner pattern of     gut microbiota that will lead to higher weight loss at 3 months post-surgery.   "
108141|NCT01870531|"     This study is to determine the clinical and neuroimaging characteristics of Transient     Ischemic Attacks in Korean populations.   "
108142|NCT01870518|"     Purpose: This is a prospective single-center, randomized, patient and evaluator-blind     clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi) versus     subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD) patients     with mild cognitive impairment (MCI).   "
108143|NCT01870505|"     The purpose of this study is to test the safety of a drug called BYL719 at different dose     levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the     patient and breast cancer. BYL719 will be given with either letrozole or exemestane to     patients with HR+ locally-advanced or metastatic breast cancer. When the recommended phase II     dose of BYL719 in combination with letrozole or exemestane has been determined in the     dose-finding phase, an additional 10 patients will be enrolled onto each arm in an expansion     phase of the study. The purpose of the expansion phase is to further define the safety and     feasibility of BYL719 in combination with letrozole or exemestane at the recommended phase II     dose, and to estimate efficacy.   "
108229|NCT01869387|"     There is evidence that noninvasive mechanical ventilation (NIV) is effective in the treatment     of severe exacerbations of COPD presenting respiratory acidosis.      The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in     patients with COPD exacerbation and hypercapnic respiratory failure without acidosis     requiring hospital admission. It is known that NIV improves respiratory mechanics, so the     primary outcome will be respiratory muscle function.      All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory     failure without acidosis will be included for a period of 12 months. The patients will be     randomized into two groups (conventional treatment or conventional treatment plus NIV).     Clinical data, blood gases, muscle strength parameters will be collected at the inclusion     time and 24h after starting NIV. Quality of life and hospital stay will be measured at     discharge. All patients will be followed for a year.   "
108144|NCT01870492|"     Limited access is a major hurdle in the treatment of AIS; many hospitals, especially rural     hospitals, do not have the infrastructure or medical support to effectively treat AIS     patients.5 Failure to recognize the signs and symptoms of stroke by the patient and/or     emergency medical services (EMS) is another barrier to the timely treatment of AIS. Several     studies, including the Paul Coverdell National Acute Stroke Registry (PCNASR), have reported     low rates of adherence to stroke care guidelines, suggesting that many AIS patients do not     receive proper treatment according to established guidelines. Thus, there remains an     increasing need to assess and address the barriers that prevent patient access to proper AIS     treatment.      Annually, approximately 20,000 patients are discharged from Wisconsin hospitals with the     diagnosis of stroke and an estimated 4,000 patients die from stroke each year in WI. To date,     there have been no statewide studies initiated in Wisconsin to assess the regional barriers     to the treatment of AIS patients with thrombolytic or endovascular therapy, and many     hospitals do not routinely collect and analyze AIS patient data.      The goal of the Improving Patient Access to Stroke Therapy (IMPACT) pilot study is to engage     community hospitals statewide to identify the regional barriers to AIS therapy in WI.   "
108145|NCT01870479|"     Main purpose: To determine if live music moderates the level of chemotherapy related anxiety,     in patients with haematological cancer      The investigators hypothesize that live music:        1. Have an ameliorating effect on physical and psychological symptoms during chemotherapy          treatment        2. May counteract the patients feeling of loss of identity and alienation in this          particular group of cancer patients.        3. Is more effective in patients with good musical abilities.        4. Is more effective than taped music.      Method: Intervention groups:        1. Listening to patient-preferred live music during chemotherapy        2. Listening to patient-preferred taped music during chemotherapy        3. Standard care      Endpoints:      Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines.      Background: In order to establish the intervention procedures, the investigators have carried     out a pilot study at the hematology department at Hospital of Southwest Denmark, including     students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot results     indicates that live music has an uplifting, pain relieving, and then releasing effect and     that music has a positive impact on hospitalisation. According to the evaluation forms filled     out by 243 cancer patients, the music experience has provided human anchorage/cohesion as a     counterweight to disease fixation and alienation Chemotherapy involves major physical and     psychological problems. Not much has been provided in the clinical setting which relieves the     symptoms of anxiety associated with chemotherapy. A review of the literature illustrate the     need for developing new potential areas of intervention that takes into account, that not     only do cancer patients face challenges in everyday life ranging from physiological changes     over social to psychological problems, but also during treatment procedures, which may cause     a higher level of anxiety associated with these procedures, e.g., chemotherapy infusion.This     project investigates to what degree live music may relieve some of these symptoms during     treatment for haematological cancer. The project is created in order to both measure     psychosocial effects as well as direct stress measures, i.e. serum catecholamine. These     physiological changes are measured in order to shed light on the mechanism behind the     potential effects of live music on discomfort in connection with chemotherapy treatment.      Perspectives: The vision of the project focus on strengthening the cancer patients' ability     to cope with physiological and psychological issues during chemotherapy sessions and to make     the patients conscious of music as an option in these coping efforts. Hopefully, the results     will provide a scientific basis for an evaluation of the perspectives and the potentials of     live music treatment during chemotherapy infusion among cancer patients.   "
108146|NCT01870466|"     The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol     and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in     healthy male subjects.   "
108147|NCT01870453|"     The objective of the study is to determine the effects of different anesthetic agents on     cognitive function in patients with Alzheimer's disease (AD). The investigators will test the     hypothesis that anesthesia with desflurane or propofol, compared to isoflurane or     sevoflurane, will have less of an effect on post-operative cognitive dysfunction in patients     with AD.   "
108148|NCT01870440|"     The purpose of this study is to determine whether an intravitreal dexamethasone implant     (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis.   "
108149|NCT01870427|"     The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection     (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF     agents.   "
108150|NCT01870414|"     The influence of cryotherapy on ankle motor control and balance of athletes is controversial.     The aim of this study is to assess the neuromuscular response of the dominant leg and body     balance basketball athletes after application of cryotherapy. The sample is distributed into     two groups. Group one will consist of 20 basketball players without a history of ankle     sprains in the past 12 months and no complaints of instability in this joint, and group two,     20 non-athletes, active, no complaints in the lower limb in the last 12 months. Will perform     the inversion movements and single-leg hop for the analysis of the electromyographic signal     of anterior tibial, peroneal, gastrocnemius (lateral), rectus femoris, hamstrings and gluteus     medius. Will also be performed kinematic analysis in search of body balance and range of     motion of the joints of the lower limbs. And yet, the analysis of the plantar support and     ground reaction force. After the initial collection of the data subjects will be submitted to     the application of cryotherapy by immersion in a time of 20 minutes, with a temperature of 6     ± 2 degrees Celsius. Data collection will be held in pre, 0, 10, 20 and 30 minutes after     application of cryotherapy. The data will be statistically analyzed to compare the results in     collection times within and between groups. The significance level is set at 5%. The data     support the intended use of cryotherapy in motor control of the inversion movement, jump and     balance of athletes.   "
108152|NCT01870388|"     The main purpose of this study is to measure how much of the study drug called baricitinib     gets into the blood stream and how long it takes the body to get rid of it. Healthy     participants and those with liver disease may enroll. The study will last about 7 days for     each participant, not including screening.   "
108660|NCT01863745|"     The purpose of this study is to collect and assess long-term safety of nilotinib in patients     who are on nilotinib treatment in a Novartis-sponsored, Oncology CD&MA study and are     benefiting from the treatment as judged by the investigator.   "
108154|NCT01870362|"     Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent     diseases associated with bone loss. Following bacterial colonization, the gingiva becomes     inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has     two distinct but interconnected etiologic components, periodontopathic bacteria and     host-mediated connective tissue-destructive responses to the causative bacteria and their     metabolic products.      A few studies have revealed that probiotic Lactobacillus strains were useful in reducing     gingival inflammation and the number of black-pigmented rods, including Porphyromonas     gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions,     its shown that application of beneficial bacteria, as an adjunct to scaling and root planing     (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on     probing.      The aim of the present study is to evaluate the improvement of periodontal health with     probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].   "
108156|NCT01870336|"     The purpose of this study is to evaluate the immediate and short-term effects of the     combination of lateral customized foot orthoses on the pain and medial knee loading during     gait among medial knee osteoarthritis patients. The effects of the combination is compared to     the single use of these devices. The investigators recruited 22 knee osteoarthritis. They     have to wear each of treatments (foot orthoses, knee brace and combination) during three     months. A fifteen days wash-out period is given after each three months. Biomechanical     evaluation is carried out before and after each three months. This evaluation consisted of     three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster     Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36(     MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During     motion analysis, ten gait trials are executed without treatment and ten with the treatment.   "
108157|NCT01870323|"     In an effort to address the physical inactivity crisis among adolescents, the present study     will examine the efficacy of using an already established Web-based social networking     platform (i.e., Facebook) to deliver a physical activity intervention to adolescents.   "
108158|NCT01870310|"     It is a randomized prospective controlled study evaluating the effect of transcatheter renal     denervation on the clinical status of patients with chronic heart failure and its safety     procedures. The working hypothesis of the study is that by performing transcatheter renal     denervation in patients with chronic heart failure and severe left ventricular systolic     dysfunction there will a resultant reduction in the renal sympathetic activation which in     turn will reduce the number of hospitalizations and deaths from heart failure.   "
108159|NCT01870297|"     The main purpose of this study is to assess the safety and tolerability of LY3025876 given     alone (Part A) and in combination with liraglutide (Part B) in participants with type 2     diabetes mellitus (T2DM).   "
108160|NCT01870284|"     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo     in participants with active AS.   "
108161|NCT01870271|"     The aim of this pilot study is to evaluate the developmentally adapted cognitive processing     therapy (D-CPT)in adolescents suffering from childhood abuse(CA)or physical abuse (PA)     related PTSD. D-CPT's feasibility and efficacy will be examined in 20 adolescents suffering     from CA or PA-related PTSD in a multicenter study (3 sites).Patients will be assessed prior     to (t0), post (t1) and 6 weeks after treatment (t2). Assessments include Clinician     Administered PTSD Scale (CAPS), UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI),     Adolescent Dissociative Experiences Scale (A-DES), and Borderline Symptom List (BSL-23).   "
108162|NCT01870258|"     prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks   "
108163|NCT01870245|"     This is a randomized, double-blind, placebo-controlled, multiple-dose study, designed to     assess the safety, tolerability, and pharmacokinetics (PK) of ACHN-975. This study will take     place in the US at one clinical site.   "
108164|NCT01870232|"     Dental anesthesia is routinely performed based on anatomical landmarks which can be variable     leading to repeated injections and failure. Ultrasonography can be used to guide these     injections by identifying the nerves, accompanying blood vessels and the bony landmarks. 20     healthy adult patients will be selected to receive ultrasound guided greater palatine nerve     block (gpn) (10 patients) or inferior alveolar nerve (ian) block (10 patients) depending on     the dental procedure they are undergoing. The study will evaluate the feasibility and success     rates of the ultrasound guided gpn and ian nerve block.   "
108165|NCT01870219|"     The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and     Tp-e interval during in patients with major depression.   "
108166|NCT01870206|"     Polio is a highly infectious disease caused by a virus. It invades the nervous system, and     can cause total paralysis in a matter of hours. The virus enters the body through the mouth     and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting,     stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible     paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing     muscles become immobilized. There is no cure for polio, it can only be prevented. Polio     vaccine, given multiple times, can protect a child for life.      Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex     compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.   "
108230|NCT01869374|"     To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in     elderly patients with a major depressive episode, who are randomly assigned to receive an     acute course of MST or ECT.      The investigators hypothesize:        1. MST and ECT will have similar antidepressant efficacy        2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of          anterograde and retrograde amnesia following the acute treatment phase.        3. At follow up, MST will show a lesser degree of persisting deficit in measures of          retrograde amnesia than ECT.   "
108689|NCT01863368|"     The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE®     lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the     safety of Systane® ULTRA after 3 months of use.   "
108167|NCT01870193|"     Glutathione is an important antioxidant protein which protects cells from harmful oxidative     stress. Elderly humans are known to have elevated oxidative stress and deficiency of     glutathione, but it is not known whether there is deficient synthesis of glutathione in     muscle tissue of elderly humans.      Mitochondria are engines of cells where food consumed is burned to make energy. Under normal     conditions the fuel of choice in the fasted state is fat, but fasted elderly humans are not     able to oxidize fat as well as healthy young humans. Elderly humans also have the highest     incidence and prevalence of being overweight and obese, and have increased storage of fat in     liver and muscle.      This study will help determine whether        1. elderly humans have diminished synthesis of glutathione in the skeletal muscle, and          whether this can be improved by supplementing cysteine and glycine (and not an          isonitrogenous placebo) in the diet;        2. improving muscle glutathione concentrations can also improve fuel oxidation in aging;        3. improvement of intracellular glutathione concentrations will be associated with a change          in total body fat content   "
109294|NCT01855425|"     The study objective is to compare the CBCT images generated by the CS 9300 to those generated     by conventional CT. It proposes a direct comparison of diagnostic image quality between the     CS 9300 and conventional CT using double image examinations.   "
108168|NCT01870180|"     Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from     meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain     a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye     symptoms. Treatments often involve gently warming the eyelids to melt this blockage which     prevents tears from spreading over the eye. Although there has been some research on     application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and     more effective method of applying heat to the eyelids. This study will test the efficiency of     these eyelid warming devices over a period of two weeks use in one eye compared to the other     non-treated eye.   "
108169|NCT01870167|"     The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can     reduce the incidence of peristomal wound infection in the paediatric population.   "
108170|NCT01870154|"     Background: Burnout syndrome is an important health problem that affects many professionals     and must be addressed globally, with both organizational measures and personal interventions.     Burnout of health professionals can be prevented in order to avoid personal, familial, and     social consequences, as well as repercussions for patients.      Methods/Design: This work describes a protocol for a controlled, pragmatic, randomized     clinical trial in 2 parallel groups: intervention and control. All health professionals from     7 health care centers (HCCs) will form the intervention group, and all health professionals     from 7 different HCCs will form the control group. The intervention group will receive 16     hours of training at their work place. The Maslach's burnout inventory (MBI), burnout     physician Questionnaire (CDPM) or burnout nurse Questionnaire (CDPE), and the 28-item     Goldberg's General Health Questionnaire (GHQ-28), validated for our setting, will be used as     measurement tools. Change in the average scores from the MBI emotional exhaustion scale will     be compared between the intervention and control groups, measured as intention-to-treat, and     the intervention will be considered effective if a minimum increase of 20% is achieved.      Discussion: Due to the deleterious consequences of burnout syndrome for people suffering from     it and for the organization where they work, it is necessary to evaluate the effectiveness of     certain interventions for its prevention. Organizational measures are important for     preventing burnout syndrome, but so is providing professionals with coping strategies, as     this group intervention intends to do.   "
108171|NCT01870141|"     Increasing evidence suggests that psychological disorders play an important role in the     development and worsening of type 2 diabetes (T2D). Among the spectrum of psychological     disorders, there is a wide literature about the association between depression and T2D and     current data show an approximately two-fold prevalence of depression in adults affected by     diabetes compared to un-affected subjects. Moreover, depression in diabetic patients is     associated with higher blood glucose levels, poorer adherence to therapeutic regimens     (whether pharmacological or therapeutic lifestyle changes), more medical complications, and     higher hospitalization rates. Nevertheless, at the best of our knowledge, the mechanism     underlying the association between depression and adverse diabetes-related outcomes is     currently unresolved.      Aim of this project is to assess the efficacy of a psychological treatment for diabetic     patients with suboptimal level of Hemoglobin A1c. This project is a RCT that seeks to address     the question if type 2 diabetic patients with suboptimal glycaemic control would benefit from     a specific psychological intervention, as specified below. A total of 80 diabetic patients     will be recruited and randomly assigned to two treatment arms:        1. Standard diabetes care        2. 24 individual sessions of psychological intervention The expected main outcome is the          improvement of glycaemic control under psychological intervention in 38 weeks of follow          up.      Secondary outcomes: reduction of depression and anxiety, improvement in self-efficacy,     perceived interference caused by diabetes, family support and eating problems.   "
108172|NCT01870128|"     Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid     arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of     various treatment regimens in early RA. Methods: This is a randomized open-labeled trial.     Patients were randomised into three groups. In group A, patients were treated with single     drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of     DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received     combination therapy as in group B and 3 pulses of methylprednisolone intravenously.   "
108173|NCT01870115|"     The investigators' long-term goal is to employ novel methods to improve bone formation and     bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs     and symptoms of degenerative joint and disc disease that commonly accompany bone loss as well     as improve quality of life (QOL). These conditions generally begin silently as early as the     menopause transition and progress to osteopenia and osteoporosis during the post-menopausal     years in aging women. The investigators also envision this will be beneficial in aging     andropausal men with these conditions. The investigators postulate that melatonin in novel     combination with other natural bone-protective agents may act in a chronosynergy manner to     prevent and correct these perturbations, reducing the risk of bone fractures, and lessening     the stiffness and pain associated with bone, joint and cartilage degeneration and improving     quality of life (QOL). The objective here, which is the investigators' next step in pursuit     of our goal, is to assess the efficacy of an alternative therapy that uses a novel     combination of bone-forming agents, melatonin, strontium (citrate)/ vitamin K2 (MK7), and     vitamin D3 on bone health in a postmenopausal population. Melatonin is a novel alternative to     current treatment(s) because it has multiple bone-protective and sleep-promoting activities     within the body, and it is relatively safe so it can be used in an aging population without     untoward side effects; strontium and vitamin D3 are shown to enhance bone mineralization and     improve post-menopausal osteoporosis. The project goal is to identify if this combination     therapy improves bone health and QOL compared to women taking placebo. The investigators'     central hypothesis is that combination therapy using melatonin, strontium, vitamin K2, and     vitamin D3 will improve bone health and overall QOL in postmenopausal women not taking this     regimen by reducing osteoclast activity and increasing osteoblast activity and by improving     subjective measures of stress, anxiety, depression and menopause-related symptoms.   "
108220|NCT01869504|"     Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an     essential tool in Chest Medicine. A common complication of drain insertion is accidental     removal of the drain, usually as a result of inadequate securing techniques, with rates of up     to 1 in 5 reported. This often results in the need for further procedures (including drain     re-siting), with associated additional risk to the patient and an increase in health care     costs. One suggested method to reduce premature drain removal is to use chest drains with     ballooned tips, much like a bladder catheter. These would provide a physical obstruction     inside the chest cavity at the insertion site, whilst being easy to use as stitching or     extensive taping may not be required.      The investigators propose a trial of a dedicated ballooned chest drain to investigate whether     a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed     during this trial to ensure that irritation of the lining of the lung or chest wall by the     balloon is not excessive.   "
108175|NCT01870089|"     Knowledge-based systems were initially developped to automatically adapt pressure support     settings during invasive ventilation, and proved to be at least as efficient as experienced     clinicians.      Non-invasive ventilation has become the standard of care for patients suffering from acute     hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in     these patients, thus reducing their hospital mortality.      NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly     correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during     NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to     the use of high pressure support levels, to the presence of leaks and/or to non optimal     expiratory trigger settings, very frequent ventilator settings adaptations should allow     reducing patient-ventilator asynchronies but require the presence of an experienced clinician     at the bedside during NIV treatment.      A computer-driven ventilator settings adaptation has the adavantage of permitting very     frequent ventilator settings adaptation whithout requiring the presence of an experienced     clinician at the bedside and could possibly improve patient-ventilator interaction.      The aim of the present study is to test the faisability of using the Smartcare NIV     computer-driven system to automatically adapt ventilator settings during non invasive     ventilation delivered because of acute respiratory failure.   "
108176|NCT01870076|"     Healing Touch improves measures of sleep the night prior to surgery, thus improving     surgery-related morbidity.   "
108177|NCT01870063|"     Correlation between FIBTEM and intraoperative blood loss   "
108178|NCT01870050|"     Principal aim of this study is to assess whether a combination of topical dapsone and     clobetasol as a topical steroid is superior to clobetasol alone as treatment of prurigo     nodularis or lichen simplex chronicus in a side to side comparison. The study is primarily     exploratory and essentially meant to inform the sponsor whether further development of a     combination treatment formulation is warranted   "
108179|NCT01870037|"     The primary objective of this study is to evaluate the safety of a single treatment of     hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections.     Two dose levels (16000 µg and 24000 µg -20 or 30 bladder wall injections, respectively) in     females with moderate OAB/DO of ≥ six months duration will be evaluated. In each dose level,     6 participants will receive hMaxi-K and 3 will receive placebo. .      In addition secondary efficacy parameters will be evaluated (change from baseline compared to     placebo), including number of micturitions per day, volume of micturitions, incontinence     episodes, pad weight, uninhibited contractions during cystoscopy, and quality of life     assessments.   "
108180|NCT01870024|"     The main purpose of this study is to know on one hand if lorazepam is more (effective) than     clonazepam and on the other hand if lorazepam is also effective as the association clonazepam     + fosphenytoin in out-of-hospital treatment of the generalized convulsive status epilepticus     in adult patients.   "
108181|NCT01870011|"     Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and     long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R     injury and maintaining renal function during renal transplant surgery is therefore very     important in order to improve post-operative outcome. This purpose of this study is to     investigate whether propofol anesthesia done in both kidney donors and recipients during     deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury     via its antioxidant and antiinflammatory properties and improve post-transplant outcome     compared to desflurane anesthesia.   "
108182|NCT01869998|"     Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting     Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter     Prospective Randomized Clinical Trial; INNOVATION study   "
108183|NCT01869985|"     The purpose of this study is to evaluate pharmacokinetics and safety after oral     administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.   "
108184|NCT01869972|"     Phenylketonuria (PKU) is a rare disease where the level of phenylalanine (one of the amino     acids) in the body is greatly increased. High levels can cause brain damage, especially in     babies and children. This brain damage can be prevented if a special low phenylalanine diet     is started soon after birth. A new drug, sapropterin, can also lower phenylalanine levels in     some patients. PKU therapy is monitored by measuring the blood phenylalanine every week, with     the goal to keep the level within a target range. Recently, studies have suggested that the     variation in the blood phenylalanine may be just as important as the absolute blood     phenylalanine level for brain outcome.      The investigators will look at the variation in blood phenylalanine level over 24 hours to     see how much the level changes. The investigators will measure this in patients with typical     PKU who are compliant with the diet and in patients who are not compliant with the diet. The     investigators will also measure this in patients with mild PKU who do not usually have as     high levels of phenylalanine. Finally, the investigators will see if patients on sapropterin     have lower variation.   "
108185|NCT01869959|"     The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It     was given as a daily injection under the skin to participants with type 2 diabetes mellitus     (T2DM) for 28 days. This study determined how long the drug stays in the body and how it     affects blood sugar levels. After screening, the study lasted about 2 months for each     participant. Participants continued their prestudy regimen of diet and exercise alone or in     combination with metformin.   "
108186|NCT01869946|"     The primary goal is to evaluate ropivacaine blood concentrations during and after local     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total hip replacement     surgery. The investigators plan to measure these levels by testing blood samples taken over a     timed period.      This will allow us to confirm whether the current regimen of local anaesthetic use is within     safe limits.   "
108239|NCT01869257|"     Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors,     surgical site infections (SSI) remain the most frequent complication of colorectal resection     (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of     local antimicrobial agents seems successful.      The primary aim of the present trial was to evaluate the efficacy of a surgical suture,     coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after     colorectal operations.   "
108240|NCT01869244|"     The aim of the study is to collect comments form users of new type of hand resting splint.   "
108187|NCT01869933|"     The present study is intended to evaluate the safety and tolerability of topical OC-10X     Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc. (Roanoke, VA) has     developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under     development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related     Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated     both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of     AMD. Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent     without the traditional toxicity and works downstream independently of growth factors. As     demonstrated by OcuCure's preclinical data, tubulin inhibition using OC-10X has promise as a     new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by     the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage     into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years     or more. If administration of OC-10X is well tolerated as a topical eye drop and is well     tolerated systemically, then OC-10X will have the potential to provide benefits to patients     with ocular diseases associated with angiogenesis.   "
108188|NCT01869920|"     Hypothesis: An educational intervention increases the proportion of mother-infant pairs using     exclusive breastfeeding   "
108189|NCT01869907|"     The purpose of this study is to determine if minocycline is effective in the treatment of     neuropathic pain. The effect of minocycline will be compared to the effect of placebo and     amitriptyline.   "
108190|NCT01869894|"     Our study is the prospective randomized study for efficacy of uncovered double bare metallic     stent compared to uncovered single bare metallic stent in malignant biliary obstruction   "
108191|NCT01869881|"     Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have     Type 2 Diabetes by using sarpogrelate and placebo.   "
108192|NCT01869868|"     The purpose of this study is to determine functional and structural changes in brain     following treatment of severe depression with electroconvulsive therapy with correlation to     clinical outcome. Our hypothesis is that there are state-dependent changes in functional     connectivity within specific neurocircuits systems, as well as structural plasticity changes     in hippocampus, when recovering from depression.   "
108193|NCT01869855|"     The aim of our study is to investigate in randomized controlled fashion whether the     recurrence and complication rate, after insertion of subperiosteal drainage in the treatment     of chronic subdural haematoma, is higher compared to insertion of subdural drainage.      We hypothesize that patients treated with a subperiosteal drainage do not show higher     recurrence rates than those treated with a subdural drainage, and suffer less complications.   "
108194|NCT01869842|"     Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and     expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas     by improving the parameters of the best stent will be useful. However, for better results for     optical coherence tomography in percutaneous interventions have little useful data on the     role. Randomized controlled study of the traditional percutaneous coronary intervention and     intervention using optical coherence tomography.   "
108195|NCT01869829|"     The overarching objective is to develop new evidence-based treatment guidelines for invasive     fungal diseases in children. To accomplish that, this protocol will focus on two specific     aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole     antifungal therapy for pediatric invasive candidiasis and for the subset of patients with     invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive     candidiasis per hospital admissions.   "
108196|NCT01869816|"     Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in     industrialized countries. Adipose tissue secretes various kinds of bioactive molecules termed     adipokines which contribute to the development of obesity-related disorders including     cardiovascular disease (CVD). Progranulin and CTRP3 are recently discovered novel adipokines.     Therefore, the investigators tried to compare circulating CTRP-3 and progranulin levels in     patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated     with CAD prevalence after adjustment for well-known CAD risk factors.   "
108197|NCT01869803|"     This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or     refractory acute myeloid leukemia or acute promyelocytic leukemia. Monoclonal antibodies,     such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the     ability of cancer to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them.   "
108198|NCT01869790|"     The purpose of this study is examine the effect of different fat types on postprandial     glucose control in patients with type 1 diabetes.      Subjects will have several admissions and, in random order, will receive lunches with     identical carbohydrate content but different fat content: lunch A will minimal fat content,     lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will     contain added cheese. Total fat content in lunches B-D will be the same. Subjects will     receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate     ratio) for the meals.      The investigators hypothesize that, despite identical carbohydrate content,the lunches higher     in saturated fat will lead to more postprandial hyperglycemia than the lunch containing     minimal fat and the lunch high in monounsaturated fat.      The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B,     C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be     greater than that of Lunch A and C.   "
108199|NCT01869777|"     This clinical trial studies bioelectrical impedance measurement for predicting treatment     outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as     bioelectrical impedance measurement, may help predict a patient's response to treatment for     acute leukemia.   "
108200|NCT01869764|"     This phase II clinical trial studies how well omega-3 fatty acid works in treating patients     with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from     breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the     effects of omega-3 fatty acid on tumor cells.   "
108241|NCT01869231|"     Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in     resolving postoperative ileus.   "
108201|NCT01869751|"     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are     among the most extensively studied gut microbial metabolites, and are associated with     cardiovascular disease, chronic kidney disease progression and overall mortality. Colonic     transit time is an important determinant of intestinal generation and uptake of bacterial     metabolites. However, it is unknown if accelerating the colonic transit time reduces the     intestinal generation and uptake of indoxyl sulfate and p-cresyl sulfate. Prucalopride is a     selective, high-affinity 5-HT4 receptor agonist with a stimulating effect on colonic motility     and transit. It is currently used in treating chronic slow-transit constipation. An     observational study will be initiated in non-chronic kidney disease patients with chronic     slow-transit constipation necessitating treatment with prucalopride to observe its effect on     serum concentrations and intestinal generation of indoxyl sulfate and p-cresyl sulfate.   "
108202|NCT01869738|"     To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked     arteries in coronary arteries in patients undergoing a stenting procedure due to having a     heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS)     or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent     will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure     ECG as compared to the comparator stent, and will have a similar effect on the rate of     all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.   "
108203|NCT01869725|"     This clinical trial studies gallium Ga 68-edotreotide positron emission tomography     (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus     contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other     somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga     68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive     neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective     as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of     patients with neuroendocrine tumors.   "
108204|NCT01869712|"     To assess the application of partially randomized patient preference (PRPP) trial model which     concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical     therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies     (acupuncture and cupping therapy) for fibromyalgia.   "
108205|NCT01869699|"     The purpose of this study is to compare the effects of intravenous acetaminophen to placebo     on body temperature and hemodynamic (heart rate and blood pressure) responses in febrile     critically ill adult patients.      There are limited data to explain the variable and unpredictable antipyretic and hemodynamic     response to acetaminophen in febrile ICU patients. The complex pathophysiology of critically     ill patients, co-morbid conditions, the effect of multiple pharmacologic and     non-pharmacologic care interventions, and/or the potential interferences with absorption of     enteral or rectal formulations may be related to variations in the antipyretic response to     acetaminophen. It is necessary for clinicians to have a better understanding of the therapy     response and potential adverse effects of this commonly administered medication, especially     the recently available IV formulation, in critically ill patients. Further research of the     antipyretic response to acetaminophen in critically ill patients is warranted to inform     evidence-based practice guidelines for fever management. Further randomized,     placebo-controlled studies of hemodynamic responses to IV acetaminophen are also warranted.      Primary Hypothesis:      There is a significant reduction in time-weighted average core body temperature over 4 hours     after administration of IV acetaminophen compared to placebo in febrile critically ill     patients.      Secondary Hypotheses:        1. There is a significant reduction in time-weighted average heart rate over 4 hours after          administration of IV acetaminophen compared to placebo in febrile critically ill          patients.        2. There is a significant reduction in time-weighted mean arterial pressure over 4 hours          after administration of IV acetaminophen compared to placebo in febrile critically ill          patients.      Adult patients with fever (≥ 38.3ºCentigrade/101ºFarenheit) in the intensive care unit will     be screened for eligibility and enrolled after informed consent. Patients will be randomized     to receive IV acetaminophen 1 gram or normal saline 100 mLs. Body temperature, heart rate,     and blood pressure will be measured at baseline and during the 4 hours post study drug     administration.   "
108206|NCT01869686|"     This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12     healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects     will be followed by a 105 day treatment-free follow-up period.   "
108207|NCT01869673|"     Difficult mask ventilation is usually studied in relation to airway management and difficult     intubation and mostly during the induction period of anesthesia.      According to the closed claim reports tracheal extubation and recovery of anesthesia is     associated with brain damage or death.      Difficult mask ventilation can also be a problem during the emergence phase of anesthesia     after extubation. Especially after nasal surgery the use of nasal tampon and casts can     resemble upper airway obstruction and facial deformity and cause difficult mask ventilation.      The effectiveness of ventilation is affected by the design of the mask. Leaks may develop due     to the inability to obtain a tight seal.      The use of an oral mask for ventilation in patients with nasal tumors and after rhinoplasty     for patients with a nasal cast has been reported. This suggests that oral mask ventilation,     rather than face mask ventilation, should be considered after nasal surgery.      The aim of this prospective randomized study is to compare the face mask and oral mask     ventilation after nasal surgery in terms of the mask ventilation classification, airway     pressure, minute ventilation and tidal volume.      Our hypothesis is that ventilation with oral mask would provide better airway pressures,     superior mask-ventilation classification and higher tidal volumes compared to face mask     ventilation in patients with obstructed nasal pasage (nasal packing and/or cast) after nasal     surgery'.   "
108208|NCT01869660|"     To determine whether shared decision making (SDM) intervention improves patient satisfaction     in patients with first-admission schizophrenia compared with usual care.   "
108209|NCT01869647|"     This is the third phase (feasibility and impact) of a three-phase project designed to derive,     validate and test the feasibility and impact of implementing clinical decision support to     safely limit the use of Computerized Tomography (CT) and its accompanying radiation and cost     in emergency department patients with suspected renal colic.      Hypothesis: Using a before and after model, integration of a clinical prediction rule into     decisions about imaging in patients with suspected renal colic will result in a reduction of     between 25-50% of radiation received from CT scanning in this population, without adverse     affects on patient-centered outcomes.   "
108210|NCT01869634|"     Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to     repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation     (CD)4+ T-cell populations, normalization of systemic immune activation, and improved     HIV-associated cardiovascular disease (CVD) risk.   "
108211|NCT01869621|"     The trough concentration of metformin will be examined in monozygotic and dizygotic twins.     Current twin study will determine the total weight of genetics on the trough concentration of     metformin.   "
108212|NCT01869608|"     Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as     hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of     type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum     screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance     test (OGTT).      However, less than a quarter of these women are screened. This recommendation has failed for     multiple reasons; the most important being that busy new mothers must deal with the major     inconveniences of returning to a sampling center for a 2h testing session, bringing baby     along or paying for a sitter, transportation, parking… A mother-friendly solution is direly     needed.      The investigators hypothesize that, in these women, results of an OGTT performed after     delivery on the last day of their hospital stay (OGTT-1) will predict results of the     recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.      The main aim of our project is to determine the optimal cut-off value for the 2h glucose     result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the     gold standard), in the same woman.   "
108213|NCT01869595|"     Objectives        1. To determine the uptake of universal HIV testing among Thai men who have sex with men          (MSM) and transgender women (TG)        2. To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among          Thai MSM/TG who test positive for HIV      Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18     years old, Have engaged in anal intercourse with a man without using a condom at least one     time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not     known to be HIV-positive (either have never been tested for HIV or have had a previous     negative HIV test)      Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in     Lampang and 5-12% in Ubonratchathani.   "
108214|NCT01869582|"     Safer Births is a research and development collaboration to establish new knowledge and new     innovative products to better equip and increase competence of health workers for safer     births and increased newborn survival worldwide.      The main objectives are:      To randomize different devices for fetal heart rate assessments. To assess if a novel Newborn     Resuscitation Monitor will facilitate newborn resuscitation in a low-resource setting. To     determine bag mask ventilation treatment and devices beneficial for neonatal outcome.   "
108215|NCT01869569|"     Rationale: Pregabalin is effective on radiotherapy-related neuropathic pain. Purpose: This     randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety     of pregabalin in treating radiotherapy-related neuropathic pain.   "
108216|NCT01869556|"     Patients having Cesarean section after they have been in labor for many hours bleed much     more, in average twice as much, as compared with patients having an elective Cesarean     section. The investigators believe a simple change in practice might contribute to reduce     this bleeding. This study will involve the use of oxytocin (also known as syntocinon),     ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is     routinely used to help contract the uterus and keep it contracted after the delivery of the     baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through     the intravenous line, while carboprost is given as an injection in the muscle. Although they     are not routinely given in every case, these are very frequently given as rescue medications     to patients who fail to respond appropriately to oxytocin. This study is designed to     determine if ergonovine or carboprost given in association with oxytocin, in a preventive     way, after delivery of the baby and placenta, can reduce the amount of blood loss during     Cesarean sections following a trial of labour.   "
108217|NCT01869543|"     Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study     to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing     asthma symptoms. One intervention group will have high efficiency filters or filtration     systems installed in their central heating and air conditioning (HVAC) system. The second     intervention group will have high efficiency portable air cleaners placed in the child's     bedroom and in the main living area. Each participant will receive true air filtration for a     year and a placebo for a year. During the placebo period a sham filter will be used that     removes very little of the particles. Measures of health effects will include days of     symptoms, unplanned utilization of the healthcare system for asthma-related illness,     short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).   "
108218|NCT01869530|"     TARGet Kids! (The Applied Research Group for Kids) is a research study enrolling healthy     children aged 0-5 years. The aim of the TARGet Kids! registry is to link early life exposures     to health problems including obesity, micronutrient deficiencies, and developmental problems.      TARGet Kids! represents an innovative collaboration between child health researchers and     children's primary care doctors (pediatricians and family physicians) to promote research     that really matters and create solutions to some of the today's biggest health concerns. The     results of this collaborative research study are not only improving the quality of children's     healthcare but also the health of children across the country. Coordinated by Sick Kids and     St. Michael's Hospital with data management services by the Applied Health Research Centre     (AHRC), TARGet Kids! is the only primary care research network for children in Canada.   "
108219|NCT01869517|"     Various approaches, including surgical and non-surgical management have been proposed for     keratoconus. One of the surgical procedures is Intrastromal Corneal Ring implantations that     have been designed to achieve refractive readjustment by flattening the cornea. There are     different models of Intrastromal Corneal rings available: intrastromal corneal ring segments     (ICRS) such as Keraring and intrastromal corneal continuous ring (ICCR) like Myoring.      Most studies of these two types of ring implantation outcomes are retrospective case series.     Thus, this Randomized Clinical Trial study was designed with the aim of Comparing visual and     refractive outcomes and complications of insertion Myoring versus Keraring using Femtosecond     laser. Keratoconus patients with compound myopic astigmatism who meet the inclusion criteria     will randomly allocated to the Keraring and Myoring groups. Subsequently, the clinical     outcomes of two groups will be compared at one,3 and 6 months after surgery.   "
108329|NCT01868074|"     This research is being conducted to determine whether use of an arch-supporting insole during     pregnancy prevents alterations in foot structure and lower limb rotational movements. The     investigators hypothesize that the arch collapse during pregnancy will be significantly     reduced in women randomized to use the supportive insole compared with women randomized to     the control group.   "
108222|NCT01869478|"     This pilot trial will be the first step toward direct comparison of delivery of endovascular     reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a     time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A     randomized trial is justified for the following reasons: 1) The high rate of death and     disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates     critical analysis of alternate therapies with therapeutic potential, 2) endovascular     treatment for acute ischemic stroke is expanding in North America without compelling evidence     of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness     analysis cannot be done without acquiring pertinent outcomes data from controlled studies.   "
108223|NCT01869465|"     Previous research undertaken among adults in high endemic districts of Busia, Adjumani, Moyo     and Nebbi reported unwillingness to take preventive treatment. A particular study conducted     in primary schools of Jinja district showed that only 30% of school children took     praziquantel during the 2011 Mass Drug Administration (MDA). Fear of side effects of     praziquantel, lack of knowledge about schistosomiasis transmission and prevention and lack of     teacher support were some of the major factors associated with the low uptake. Similar     reasons for non-uptake have been reported elsewhere. Thus, measures are needed to increase     uptake of Mass Drug Administration (MDA) in Uganda. There is no doubt that health education     facilitates a better understanding of the obvious risks to health, including the knowledge of     preventing parasitic infections among primary school children. Better compliance to treatment     for schistosomiasis among school children can be achieved through implementing carefully     designed programs involving face to face education methods. Increasing knowledge about     schistosomiasis transmission and prevention and implementing measures to mitigate the side     effects attributable to praziquantel, such as providing a snack prior to drug administration     may improve uptake of the drug among school children.      Hypothesis- Provision of a pre-treatment snack is effective in improving uptake of preventive     treatment for intestinal schistosomiasis among primary school children.   "
108224|NCT01869452|"     A first therapeutic education is given before patient's discharge at the hospital, then a     dedicated nurse follows patients through the phone,regularly according to patients' needs,     continues to give advise on risk factors, information on medication and alert symptoms and     therapeutic education.   "
108225|NCT01869439|"     The purpose of this study is to test wounds found on the outside of the body surface with an     investigational medical imaging device that collects visual pictures and thermal digital     pictures of the wound site. The investigational device has not been approved by the Food and     Drug Administration (FDA).      The medical imaging device is non-contacting and is non-radiating (delivers no energy to the     body). It passively collects pictures (typical digital color photographs)and thermal pictures     (black and white digital photographs of heat at the body surface.)   "
108226|NCT01869426|"     Infantile colic is one of the most commonly reported medical problems within the first three     months of life causing appreciable distress for both parents and pediatricians.      It appears that multiple independent origins might be involved: amongst them infant's     difficult temperament, inadequate mother-infant communication or maternal anxiety, transient     lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal     smoking during pregnancy or after delivery. Consequently, various treatment approaches have     been tried to alleviate this condition.      Recent studies have suggested that changes of intestinal microflora of a newborn may play an     important role in pathogenesis of infantile colic. Therefore, dietary supplementation with     probiotics has been proposed for the improvement of this condition.   "
108227|NCT01869413|"     A cystectomy is the removal of the bladder and adjacent organs in patients with bladder     cancer. This often results in significant blood loss, and about 60% of patients will require     a blood transfusion during or up to 30 days after surgery. Significant blood loss may result     in cardiovascular morbidity, and the use of blood products are expensive and expose patients     to risk.      Tranexamic acid reduces breakdown of hemostatic blood clots and it has therapeutic benefit     when used in other surgical procedures to reduce blood loss and the need for transfusion. The     current study will be the first to evaluate whether tranexamic acid is effective and safe to     use during radical cystectomy. The results of the study will have an immediate impact on     patient care.   "
108228|NCT01869400|"     Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined     patient groups, which are not representative for the whole patient population.      Especially elderly patients and patients with co-morbidities are underrepresented in clinical     trials.      This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD     combination therapy in a general patient population to evaluate if the data collected in the     clinical trials can be assigned to a general patient population.   "
108242|NCT01869218|"     This study is aimed to determine the feasibility of obtaining and molecularly characterizing     pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly     characterizing archival and post-treatment tumor biopsies, to assess molecular expression     changes between archival and baseline tumor samples, and to assess molecular expression     changes between tumor samples obtained at baseline and at the time of disease progression.   "
108231|NCT01869361|"     Background: Indomethacin is frequently used as a tocolytic, however there is currently only     scant evidence to support its efficacy.      Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and     maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin     for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor     randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48     hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously     administered, and magnesium sulfate for neuroprotection. Ultrasound performed before     initiation of study drug and after completion of study medication for amniotic fluid index     and fetal cardiac assessment.   "
108396|NCT01867203|"     Patients needing lipid lowering therapy will be recruited before initiation of the treatment.     For each patient, total and LDL cholesterol levels before start of therapy will be measured.     One, three and six months after his/her first visit, when steady-state will be reached, for     each included patient, the cholesterol levels will be re-assessed in order to evaluate the     response to statin therapy calculated as the amplitude of cholesterol reduction. The aim is     to assess the association between patient's genotype and the response to statin therapy.   "
108232|NCT01869348|"     As individuals age, their physical activity decreases and sedentary time increases. Even     small changes in these two behaviors can greatly decrease risks for several major health     problems, including cardiovascular disease, diabetes, and many cancers. Studies that use     pedometers to encourage walking have successfully increased physical activity, but do not     address sedentary behaviors such as television watching. The investigators propose to use a     novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and     decreased sedentary time. First, the investigators will recruit 10 adults to participate in a     brief intervention for six weeks. They will wear the wrist-based activity monitor and use a     mini-tablet device to see feedback on their activity and sedentary time. They will also     receive brief counseling weekly. The investigators will use this first study to investigate     the basic feasibility of the intervention materials. Next, the investigators will recruit 20     adults and randomize them to receive the intervention for 12 weeks or to a waiting list.     Here, the investigators will test the intervention with refinements made based on participant     responses from the first small study. Our primary outcomes will be measures of feasibility     and acceptability across all parts of the study. The investigators hypothesize that the     intervention will be feasible and acceptable to the participants. The investigators will also     measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings     of motivation.   "
108233|NCT01869335|"     Radiography of breast specimens is currently the only radiological procedure used to verify     removal of microcalcifications and presence of tumor-free margins after breast surgical     resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not     detected by radiography in resected breast tumor specimens and/or its ability to verify     tumor-free margins in breast cancer detected by MRI only.   "
108234|NCT01869322|"     When people break their arm and arrive at Oregon Health and Science University's Emergency     Department (OHSU ED), they are treated with a short-term means of immobilizing their broken     arm. The two most common ways of stabilizing the broken parts of the arm are 1) with a     plaster-based coaptation splint, or 2) with a soft cloth sling and swathe. These hold the arm     steady until the patient can schedule an appointment with the OHSU Orthopaedic Trauma clinic     where they will receive definitive evaluation and stabilization/fixation. In much of the     orthopaedic literature coaptation splints are the default immobilization method. The     investigators hypothesize however, that sling and swathe immobilization may be equally     effective for short term stabilization, while being faster to apply, and more comfortable for     the patient. This randomized, unblinded prospective study will follow the satisfaction,     quality of life and limited functional outcomes of all enrolled participants during the first     week following their injury.   "
108235|NCT01869309|"     The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg     LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who     exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated     Phosphoprotein-Phosphorylation (VASP-P) >50%.   "
108236|NCT01869296|"     The purpose of this study is to compare the cecal intubation rate between two endoscopy water     pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy     examination in unsedated patients undergoing diagnostic colonoscopy.   "
108237|NCT01869283|"     Neck pain is a prevalent musculoskeletal dysfunction. Studies point that individuals with     chronic pain have metabolic, vascular and electromyographic changes in trapezius muscle.     Moreover, a common clinical sign in this muscle in subjects with neck pain is the presence of     myofascial trigger points. These are related to the sensory, motor and autonomic changes,     being defined as palpable nodules located in the taut band of skeletal muscle. In this     context, the focus on treatment modalities stands out in the literature, however, other     resources commonly used in clinical practice still lack scientific evidence. Therefore, the     aim of this project is to evaluate the effectiveness of physiotherapy resources in the     treatment of myofascial trigger points in the trapezius muscle of patients with neck pain.     For such, volunteers with neck pain for more than 90 days, of both genders, aged between 18     and 59 years and bilateral myofascial trigger points in the upper trapezius will be     randomized into the following groups: group 1 (kinesiotherapy, n = 20), group 2     (kinesiotherapy + static ultrasound, n = 20), group 3 (kinesiotherapy + diadynamic currents,     n = 20) and group 4 (untreated control, n = 20). Volunteers will undergo ten sessions of     treatment, being realized the following evaluations: surface electromyography, infrared     thermography, numerical scale of pain assessment, algometry, Neck Disability Index and skin     impedance. For data analysis, normality test will used to verify the data distribution and     consistent statistical test for the appropriate comparisons within and between groups, and     thus considered two factors in the comparisons, time and group. Will adopt a significance     level of 5%.   "
108238|NCT01869270|"     Hypothesis: To study the natural history of Tay-Sachs disease and evaluate therapeutic     interventions.      This study is intended to work in collaboration with NCT00668187 A Natural History Study of     Hexosaminidase Deficiency. Because so few patients with Tay-Sachs disease present annually,     we will maximize both research projects by enrolling patients in both studies. For this     present study, we will perform retrospective medical record review to gather data. Through     this medical record review, we will collect biomarker analysis results, neuroimaging report     data, quality-of-life questionnaire data and ophthalmology exam findings. If the subject has     undergone therapy or treatment, the results will be noted.   "
108243|NCT01869205|"     To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients   "
117971|NCT01741792|"     The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab is     effective and safe in the treatment of patients with relapsed/refractory diffuse large B-cell     lymphoma (DLBCL).   "
108298|NCT01868477|"     The primary purpose of this trial is to assess the effect of treatment with deferasirox     combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low-     and int-1-risk myelodysplastic syndrome.      The addition of deferasirox to erythropoietin could lead to a potential synergism with the     reduction of reactive oxygen species, through both the NF-kB pathway and the control of free     toxic iron. This may create a better environment in the bone marrow for a better response     with erythropoietin.      This study is designed to test in a prospective way the combination of deferasirox with     erythropoietin in term of their effect on hematopoiesis.   "
108244|NCT01869192|"     A primary objective of this study is to evaluate the in vivo response of tumor to     chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique     opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor     tissue. The investigators plan to evaluate several different questions by comparing gene     profiles in different phases of treatment in this study. These are outlined below.      Hypotheses        1. Chemotherapy enriches for tumor cell populations that have enhanced resistance and          survival mechanisms. These mechanisms will in part be identifiable through changes in          gene expression profiles pre vs. post treatment.        2. Use of two distinct chemotherapy selection pressures, for example a DNA-damaging regimen          (epirubicin and cyclophosphamide) or a mitotic spindle/metabolic targeted regimen          (docetaxel and capecitabine), will allow for the identification of a smaller set of          genes associated to resistance and survival mechanisms of broad importance.        3. Genes associated with enrichment for resistance and survival mechanisms will not be          present in large amounts pretreatment in tumors destined for complete pathologic          response.   "
108245|NCT01869179|"     The investigators will recruit 450 older adults and will utilize 12 Administration on Aging     (AoA)-supported senior centers to implement a multisite, cluster randomized (by center),     wait-list clinical trial. Centers will be randomized to receive the choir program immediately     (intervention group) or after a 6-month delayed intervention phase (control group). The     community choirs will be led by professional music directors. The investigators will assess     both primary and secondary outcomes at baseline, 6 and 12 months, with the main intervention     group comparison being at 6 months. The investigators will also evaluate the start-up and     ongoing program costs for senior centers, including cost/person served and determine quality     adjusted life years.      The hypotheses are:        1. Compared to delayed intervention controls, participation in a community choir program          will be associated with improvements/maintenance on the primary outcomes of physical          function (balance, walking speed, strength), depressive symptoms, and cognition          (executive function and memory) at 6 months. The investigators also predict within-group          improvements on these primary outcomes at 12 months.        2. Compared to delayed intervention controls, participation in a community choir program          will be associated with improvements in the secondary outcomes of well-being (depressive          symptoms, loneliness, resilience, social participation, health-related quality of life,          shortness of breath, functional status, falls, and health services use) at 6 months. The          investigators also predict within-group improvements on these secondary outcomes at 12          months.   "
108246|NCT01869166|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous T cells may make the body build immune response to kill cancer cells.      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in     treating patients with EGFR positive advanced/unresectable operation solid tumors, such as     lung cancer, colorectal cancer，ovary cancer，cholangiocarcinoma，pancreatic cancer，renal     carcinoma and other relapsed/metastatic tumors.   "
108247|NCT01869153|"     Growth is poor in preterm infants, partly due to difficulty identifying when growth is slow.     The investigators will examine the use of a computer program to try and identify periods of     growth slowing in preterm babies, and compare those results to the usual assessments made on     patient care rounds.   "
108248|NCT01869140|"     To study the immediate effect of spinal manual therapy on pain perception in normal subjects   "
108249|NCT01869127|"     Small association studies have hypothesised that shoes protect against hookworm infection.     The purpose of this pragmatic study was determine, under field conditions, whether school-age     children on Pemba Island, Zanzibar, would wear shoes and if shoes protected them against     hookworm infection.   "
108250|NCT01869114|"     This phase II trial studies how well sirolimus and azacitidine works in treating patients     with high-risk myelodysplastic syndrome or recurrent acute myeloid leukemia. Sirolimus may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as azacitidine, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Sirolimus and     azacitidine may kill more cancer cells.   "
108251|NCT01869101|"     The purpose of this observational study is to assess the treatment and outcomes of patients     with prediabetes in community-based clinical practices.   "
108252|NCT01869088|"     The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5     Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not     amenable to surgery or local ablative therapy.   "
108253|NCT01869075|"     Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary     embolism (PE, is one of the common and preventable complications of hospital stay. VTE     prophylaxis through the use of evidence-based anticoagulant medication options or mechanical     prophylaxis have been shown to reduce this risk and improve patient safety. Despite an     abundance of evidence, use of VTE prophylaxis remains low.      This study assesses the effectiveness of quality improvement strategies (use of pre-printed     orders, audit and feedback, involvement of the pharmacist as project need and as a reminder     to the physician, and education of staff) on use of appropriate VTE prophylaxis. The study     aims to measure if the use of these strategies improves the use of VTE prophylaxis and     therefore, improves patient safety and patient care by reducing the risk of developing DVT or     PE.   "
108254|NCT01869062|"     The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT     parameters by SonR technology is able to increase the rate of CRT-D responders, based on     significant LV reverse remodeling, as compared to Standard of Care settings.      This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard     of care (SoC) programming methods in providing appropriate LV filling, as expected from the     Ritter method.   "
108255|NCT01869049|"     This project was undertaken by Qilu Hospital of Shandong University and other well-known     hospitals in China. In order to report the alteration on the macrophage function in the     spleen tissue of primary immune thrombocytopenia (ITP).   "
108256|NCT01869036|"     The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal     anesthesia in children who undergo renal surgery in our department.   "
109295|NCT01855412|"     The purpose of this study is to evaluate acute and long term clinical and economic outcomes     of endovascular procedures to treat Peripheral Arterial Disease (PAD).   "
108257|NCT01869023|"     Malignant pleural mesothelioma (MPM) is a rare disease, but with a very high mortality. MPM     is frequently found in advanced stages. The standard treatment in advanced pleural     mesothelioma is cisplatin-based chemotherapy combined with pemetrexed/raltitrexed (phase III     studies showed its benefit in response and overall survival compared with cisplatin alone).     There are other active drugs such as liposomal doxorubicin and gemcitabine. Unfortunately,     cost is an important factor to consider in our population and standard treatments are very     expensive. Gemcitabine 250 mg infused over 6 hrs in combination with cisplatin, compared to     the standard administration of gemcitabine 1250 mg infusion of 30 minutes in NSCLC, combined     with cisplatin showed 75 mg shown in a study to be equally effective in treating cancer     non-small cell lung. A phase II study using this strategy for advanced MPM has shown     promising results. Gemcitabine administered in low dose in a six hour infusion may reduce     cost of treatment without altering the effectiveness.      Primary Objective.      -Evaluate the response of treatment with gemcitabine at a dose of 250 mg/m2SC in 6-hour     infusion combined with cisplatin in patients with unresectable malignant mesothelioma.      Secondary objectives.        -  Evaluate toxicity of the combination of gemcitabine at a dose of 250 mg/m2 infused over          6 hours in with cisplatin in patients with unresectable malignant mesothelioma.        -  Evaluate the progression free survival (PFS) and overall survival (OS) in patients with          unresectable MM treated with this combination.      Hypothesis:      Combination therapy of gemcitabine at a dose of 250 mg/m2 infusion of 6 hrs applied on day 1     and 8 combined with cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles is a treatment     that provides similar results in responses when compared with previous studies with the same     combination therapy, but with a conventional administration (gemcitabine 1,250 mg in 30     minutes on days 1, 8 and 15).   "
108258|NCT01869010|"     The objective of the present study is to analyze the overall tubular function, and in     particular that from the proximal tubule and the thick ascending loop of Henle (TALH) in     patients with HIV infection receiving or not tenofovir-containing antiretroviral treatment in     comparison with seronegative controls, by applying a validated tubular physiological test     known as Low sodium infusion test.      Hypothesis is that patients with HIV infection and normal renal function will show     subclinical tubular abnormalities compared with seronegative controls   "
108259|NCT01868997|"     The primary objective of this study is to investigate the efficacy, safety, and tolerability     of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months,     in comparison to placebo, in the treatment of participants suffering from active TED.      Funding Source - FDA OOPD   "
108260|NCT01868984|"     The objective of this study is to evaluate the safety and effectiveness of the use of     intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous     dialysis access fistula stenosis.      A fistulogram will be performed in standard fashion. The diagnostic component will include     evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or     graft, plus venous return up to the heart. The location, vessel size, lesion diameter and     percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at     this point.      All patients will then receive standard therapy for their stenosis. This will include     intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond     poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations)     will be stented. Stent selection will be based on clinical setting. Initial stent treatment     will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include     initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard).     Documentation of location and type of treatment for each lesion treated will be recorded.      Once standard treatment is completed, the operating surgeon will be informed of the patient     randomization: treatment (paclitaxel) or control. For subjects assigned to treatment,     Paclitaxel solution treatment of each lesion encountered from proximal to distal will be     attempted until the 20 mg Paclitaxel dose limit is met.      A TAPAS infusion catheter will be used for all paclitaxel dose administrations. The TAPAS     infusion catheter will be positioned to reduce the presence of branches which permit the loss     of paclitaxel from the treatment zone. After the full outflow vein segment is treated, the     fistulogram is completed in the standard fashion. Prior to removal of the sheath, a final     angiographic study of all areas treated is performed to document patency and lesion     appearance.      For the control group, instead of paclitaxel administration, a sham treatment period of 10     minutes is allowed to elapse followed by the performance of the final completion angiogram.     Any additional lesions identified with this study are then treated appropriately following     standard technique.      All patients will follow the same follow up evaluation schedule.   "
108261|NCT01868971|"     The purpose of this prospective clinical study is to establish the feasibility and usability     of the ENDORINGS™ when used during standard colonoscopy procedure.   "
108262|NCT01868958|"     More than half of the middle-aged population has radiologic evidence of cervical spondylosis     (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy (CSM),     a condition in which the spinal cord is impaired, either by direct mechanical compression or     indirectly by arterial deprivation and/or venous stasis. In this study we aim to test the     hypothesis that diffusion tensor imaging can provide prognostic information on the integrity     of the spine in these patients which is unavailable from conventional MRI images   "
108263|NCT01868945|"     The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of     vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in     physically frail elderly people after 24 weeks of daily supplementation with different doses     of Hy.D Calcifediol 25 SD/S compared to vitamin D3.   "
108264|NCT01868932|"     Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used     in bronchodilator therapy for acute viral wheezing in all children under age 6 years will     provide superior symptom relief leading to decreased admission rates from the Emergency     Department.      The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered     with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group)     in a prospective, double blind, randomized controlled, multi-centre clinical trial of     children under age 6 years presenting to the ED with acute viral-associated wheezing.   "
108265|NCT01868919|"     Joint research (quantitative and qualitative methodology) with quasi-experimental design,     before-after without control group to evaluate the pilot implementation of Positive Parenting     Program (Triple P) in the context of primary health care in Chile. The hypothesis is that the     program is feasible and acceptable to the Chilean population.   "
108266|NCT01868906|"     The aim of this study is to assess, with 18F-FMISO PET, hypoxia in high grade gliomas and     changes by spinal cord stimulation in a subset of patients. Additionally, the potential     correlation with pathological, imaging and clinical parameters will be analyzed.   "
108267|NCT01868893|"     This is a multicenter, open-label, single-arm, expanded access treatment study designed to     provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL)     in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab     administered in combination with chlorambucil. This study will enroll patients with     previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines     (Hallek et al 2008), as assessed by the investigator.   "
108280|NCT01868711|"     Psychological mindedness(PM) is a meta cognitive process in which the person uses his     cognitive and affective abilities to better understand his thoughts, feelings, and his     behaviors as they interact with his internal experiences and his external experiences in the     world, and dynamically modifies his behavior to move towards self actualization, in a manner     positive to himself and the world. We investigate whether assessment of PM can distinguish     depressed patients who benefit from CBT.   "
109689|NCT01850446|"     The purpose of this study is:        -  to assess efficiency of Ergoferon for treatment of influenza;        -  to assess safety of Ergoferon for treatment of influenza;        -  to compare efficiency of Ergoferon and Oseltamivir for treatment of influenza.   "
108268|NCT01868880|"     The aim of this prospective, randomized and controlled trial is to evaluate the use of the     ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of     beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in     single-chamber or dual chambers ICD recipients HF patients with moderate to severe left     ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a     12-months follow up.      Besides the investigators want to assess if the combination of ivabradine to a low-dose of     beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a     lower degree of left ventricular dysfunction progression, the reduction of ventricular     arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of     life in ICD heart failure patients.   "
108269|NCT01868867|"     The goal of this study is to examine the use of new technologies in disseminating and     improving CBT treatment for adolescent depression. An on-line therapist training tutorial     will be followed by 12 weeks of CBT treatment according to the training protocol. CBT     treatment will be augmented with the use of automated text messages for homework reminders     and reinforcement of learning. In session patient education and review of CBT concepts will     be augmented through teaching materials delivered via iPad. 16 therapists will be recruited,     each treating 4 depressed adolescents. Half the therapists will be randomly assigned to TAU,     followed by the training intervention. Automated patient outcomes measures will be examined.   "
108270|NCT01868854|"     The location of the catheter tip in radiographic planes 1 and 2, is a protection factor for     the mechanical performance of peritoneal Dialysis. Instead radiographic planes 3 and 4 are     risk factors.   "
108271|NCT01868841|"     The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when     derived from a large field of view Anger SPECT system and from a small field of view high     sensitivity (CZT) SPECT system.   "
108272|NCT01868828|"     A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50     previously untreated subjects with multiple myeloma will be enrolled. The study will consist     of 6 phases, screening, treatment and follow-up.   "
108273|NCT01868802|"     A randomized multicentric parallel arms study involving the use of ketamine for     treatment-resistant depression will be held at three national health provider clinics in the     Mexican population. The purpose of this study is to determine whether clinical response seen     in previous studies is replicable in this population.   "
108274|NCT01868789|"     The purpose of this study is to compare the average joint motion and joint axis orientation     of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD)     and a control group of patients without foot deformity, using weight-bearing CT technology.   "
108275|NCT01868776|"     The purpose of this study is to determine the effect of buffered lidocaine (a numbing     solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing)     solutions have shown promise in some medical and dental research. Patients presenting with     toothaches will be given either a buffered numbing solution or a nonbuffered numbing     solution. Neither the patient nor the operator will know which solution they will receive.     Root canal treatment will be performed on the tooth and the ability of the buffered versus     non-buffered numbing solutions will be compared.   "
108276|NCT01868763|"     Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching     have the potential to support lifestyle change and weight loss. Therefore, the aim of our     randomized controlled trial was to examine the effect of telemedicine with and without     coaching in comparison to a control group on weight loss in overweight participants.   "
108277|NCT01868750|"     One of the major side effects of surgery to remove the thyroid gland is transient (lasting     for a short time) low calcium levels in the blood, or hypocalcemia. Low calcium levels can     cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet,     severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities.     Severe symptoms are life threatening, so it is important to start the management of these     symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a     few extra days in the hospital.      The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the     calcium needed to make strong bones and teeth. The purpose of this study is to determine if     taking vitamin D before surgery to remove the thyroid gland affects whether or not you may     have low calcium levels after your surgery and to test the hypothesis that those who are     given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital     stay.   "
108278|NCT01868737|"     A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal     high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period     July 2011 to August 2012. The primary objective of the study was to assess the effect of     probiotics on the incidence of NEC in high risk infants born to HIV-positive and HIV-negative     women.      Throughout the study period, the standard of care protocol consisted of one dose (5 drops)     probiotic/placebo daily for 4 weeks (28 days). This provided the study group with L.     rhamnosus GG (0.35 x 109 colony-forming units [CFU]) and B. infantis (0.35 x 109 CFU) daily.     The control group received placebo consisting of medium chain triglyceride (MCT) oil.     Supplementation of the probiotic/placebo was initiated when enteral feeds started. Probiotic/     placebo supplementation was delayed/ halted in the event of: the infants being nill per os     (NPO); when a query Necrotizing Enterocolitis (NEC) was suspected the infant continued with     treatment until a confirmed a positive diagnosis of NEC I was made through abdominal X-ray;     if the infant remained a query NEC and was NPO the infant did not receive probiotics/ placebo     until the enteral feeds were commenced again. Supplementation was discontinued when     HIV-exposed infants had a positive polymerase chain reaction (PCR) result on day 14 of life.      All study participants received human breast milk. Both the probiotics and placebo were mixed     with the mothers own breast milk or donor breast milk before administration via the     orogastric tube or orally. The probiotic/ placebo was added to the breast milk by the     researcher and two research assistants who were blinded and not involved in the routine care     of the infants. Participants exited the study on day 28 after birth or upon discharge from     the hospital.   "
108279|NCT01868724|"     This study is to collect blood and urine samples to help identify and validate protein     biomarkers of recovery from moderate or severe acute kidney injury (AKI).   "
108281|NCT01868698|"     Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a     narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis     and thromboembolic events. One of the main risk factors for the development of DAP is     diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of     this study is to evaluate the effects of three treatment modalities for PAD on the blood flow     velocity. It is a crossover study. Fifteen women with diabetes receive three types of     treatment, the order defined according draw: high voltage electrical stimulation, shortwave     diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler     ultrasound. The hypothesis of this study is that physical therapy resources increase the     circulation of the lower limb.   "
108282|NCT01868685|"     The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in     Group III failure to wean patients, as compared to placebo controls.   "
108283|NCT01868672|"     The burden of tobacco use falls disproportionately on low-income populations, through high     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in     creating smoke-free environments in the U.S. over the past two decades has left smoker's     homes as one of the primary sources of exposure to secondhand smoke for both children and     nonsmoking adults. Intervention research that identifies effective and practical strategies     for reaching the minority of households that still allow smoking in the home has considerable     potential to reduce smoke exposure, but suitable channels to reach low-income families are     limited.      The proposed research will systematically test an intervention designed to create smoke-free     homes in low income households among 2-1-1 callers. During this randomized control trial,     researchers will disseminate and evaluate a brief smoke-free homes intervention through the     established infrastructure of a North Carolina 2-1-1 call center. 2-1-1 is a nationally     designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for     directory assistance, that links callers to community-based health and social services. The     main hypothesis to be tested is that a higher proportion of households in the intervention     group will establish and maintain a smoke-free home than in the measures-only control group.   "
108284|NCT01868659|"     Diagnostic errors are common, but they have been largely ignored by patient safety groups.     Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics     (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors,     but we know little about how to resist them. Faulty thinking has plagued other high-risk,     high-reliability professionals, such as airline pilots and nuclear plant operators. These     professions have learned from their mistakes and have developed checklists to help prevent     them. The medical profession has started to use checklists and time-out periods in the     operating room and intensive care unit, but these strategies have not been used to reduce     diagnostic errors. The most common reason that physicians fail to make the correct diagnosis     is that they never consider it. This failure could potentially be prevented if the physician     took a time-out to review a checklist. Our broad long-term goal is to reduce diagnostic     errors by developing interventions that help counter faulty diagnostic thinking. The specific     aims of this project are to (1) determine the feasibility of taking a diagnostic time-out in     the acute outpatient setting (urgent care clinic and emergency department), (2) determine if     new diagnostic possibilities are seriously considered as a result of the time-out and     checklist, and (3) compare the initial differential diagnosis with the new differential     diagnosis following the time-out, and with the discharge diagnosis documented in the medical     record, and with the final diagnosis based on a one-month follow-up. To achieve these aims,     the investigators will ask 5 urgent-care physicians to complete a time-out procedure for 10     diagnostically challenging adult patients and 5 physicians will serve as controls (no time     out) for 10 diagnostically challenging patients (total of 100 patients). The investigator     will ask the intervention physicians to take a 2-minute time-out to review a     complaint-specific differential-diagnosis checklist, which includes the differential     diagnosis for 60 common presenting complaints, such as dyspnea and chest pain. The time-out     will occur at the conclusion of the history and physical exam. We will use descriptive     statistics and qualitative methods to characterize physicians' reactions to the time-out and     checklists. We will use this pilot project to plan a larger study that will determine the     risks and benefits of diagnostic time-outs and checklists.   "
108285|NCT01868646|"     The purpose of this study is:        -  to assess clinical efficiency of Subetta in the combined treatment of type II diabetes          mellitus;        -  to assess safety of Subetta in the combined treatment of type II diabetes mellitus.   "
108286|NCT01868633|"     The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when     used as part of a multimodal regimen to manage post cesarean delivery pain.      We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal     analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid     consumption and pain   "
108287|NCT01868620|"     The primary purpose of the protocol is to compare the current standard CXL with iontophoretic     CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.      Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the     progression of keratoconus. In the current standard CXL, the central corneal epithelium must     be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium     debridement can cause severe pain, infection and stromal haze. The study hypothesis is that     iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.   "
108288|NCT01868607|"     The objective of the study is to evaluate the reliability of the impedance data in adult     subjects measured with five different FOT devices.   "
108289|NCT01868594|"     The purpose of this study is:        -  to assess clinical efficiency of Subetta in the combined treatment of type I diabetes          mellitus;        -  to assess safety of Subetta in the combined treatment of type I diabetes mellitus.   "
108290|NCT01868581|"     This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between     two explorative formulations of insulin degludec (insulin 454) and between two explorative     insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without     buffer, in healthy male subjects. The investigated formulations are explorative, not similar     to the proposed commercial formulation.   "
108291|NCT01868568|"     This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and     insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of     insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30     (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to     four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high     concentration were explorative formulations, not similar to the proposed commercial     formulation.   "
108292|NCT01868555|"     This trial is conducted in Asia. The aim of this trial is to assess the safety,     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the     effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp)     preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male     subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar     to the proposed commercial formulations.   "
108299|NCT01868464|"     This is a Phase I open-label, dose escalation trial to evaluate the use of Tice® BCG as a     challenge for future assessment of in vivo TB immunity. Subjects will be recruited from the     target population reflecting the community at 2 VTEU sites. Enrollment will occur over 14     months. Subjects who provide informed consent will be screened, and up to 120 eligible, HIV     and TB uninfected subjects, 18-45 years, inclusive, will be enrolled for study interventions     and sequentially assigned to 1 of 4 dose groups. Doses of Tice BCG from 2 to 16x10^6 cfu will     be delivered ID in a dose escalation format to 4 groups of 30 subjects per dose group.     Primary Objectives: 1) Evaluate the safety of different doses of ID Tice BCG for use as a     human challenge model for TB infection. 2) Examine shedding from ID challenge sites after     administration of different doses of Tice BCG in TB naive healthy subjects. 3) Evaluate the     reproducibility of BCG shedding over time with both quantitative PCR and culture.   "
108300|NCT01868451|"     The purpose of this study is to compare the outcomes across the 4 different treatment groups.     The investigators hope that this treatment will improve the ability to cure more patients     with HL and also limit the long-term side effects from the treatment. Although eliminating     radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it     is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the     Hodgkin lymphoma coming back after initial treatment.   "
108301|NCT01868438|"     The purpose of this study is to compare the bioavailability of two formulations (tablets and     granules for dispersion) of the antimalarial drug Pyramax (which is a combination of     pyronaridine and artesunate).   "
108302|NCT01868425|"     This study will evaluate the effectiveness of an aggressive multimodal regimen versus     standard multimodal for ACL repair using hamstring graft for patients having surgery in our     outpatient surgicenter.   "
108303|NCT01868412|"     In recent years, salve prepared from Norway spruce (Picea abies) resin and refined honey from     manuka myrtle (Leptospermum scoparium), has successfully been used in medical context to     treat both acute and chronic surgical wounds. The objective of this prospective, randomized     and controlled clinical trial is to investigate healing rate and healing time of surgical     wounds in patients, who have undergone peripheral vascular surgery, and whose complicated     wounds are candidate for topical treatment with the resin or honey. In addition, factors     contributing with delayed wound healing, antimicrobial properties, safety and     cost-effectiveness of the resin salve and medical honey will be analyzed.   "
108304|NCT01868399|"     Since 2009, Kaohsiung Medical University Hospital organized a medical team to provide the     medical service for people in Solomon Islands thru Taiwan Health Center at the local. In     addition to Malaria and pulmonary tuberculosis, the investigators also found dengue virus,     Japanese Encephalitis virus, Chikungunya virus infections and intestinal parasitic infections     might be the existing but overlooked and neglected medical issues in Solomon Islands. These     infections show similarity in clinical manifestations and usually difficulty in clinical     diagnosis, instead these infections rely on the laboratory identification with good     laboratory quality and facility.   "
108305|NCT01868386|"     Radiation therapy is one of the standard treatments for men with prostate cancer who have     detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after     surgery. When radiation therapy is given to patients who have an increase in PSA after     surgery, it is called salvage radiation therapy. Currently the standard radiation therapy     course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy     after prostate removal causes unpleasant side effects. A shorter course of radiation therapy,     known as a hypofractionated course, gives fewer but higher doses of radiation than standard     radiation.      The purpose of this study is to test the safety of a shorter course of radiation therapy at     progressively lower dose levels and shorter lengths of treatment (hypofractionated) with     patients who have had their prostate removed. The study will assess whether the     hypofractionated course works better without causing additional side effects to the remaining     cancer cells in the prostate bed.   "
108306|NCT01868373|"     To confirm and extend the work of Trede and Rask-Madsen (Lancet 1989;1:1156-1160) that     administration of a defined fecal microbiota will lead to rapid and sustained resolution of     C. difficile associated chronic relapsing diarrhea.      The current rationale behind FMT for CDI is that introduction of microbes from a healthy     donor allows restoration of a normal microbial community in the diseased host with consequent     suppression of C. difficile colonization and disease pathogenesis. The first modern use of     FMT was reported in a 1958 case series of 4 patients with pseudomembranous enterocolitis. The     first case of confirmed CDI treated with FMT was reported in 1983; treatment was curative.     Until 1989, retention enemas were the most common technique for FMT. Alternative methods for     delivering FMT have included fecal infusion via duodenal tube (1991), rectal tube (1994), and     colonoscopy (1998). FMT for recurrent CDI has been used successfully whether administered by     nasogastric tube, rectal administration by colonoscopy, rectal tube including     self-administration at home by enema. FMT has proven to be remarkably effective and     remarkably safe without any significant problems (see below and attached reviews and     meta-analyses).      Increasing, interest is emerging regarding the changes in the intestinal microbiota     associated with CDI. In 2008 Chang et al. constructed small (< 200 sequences per subject) 16S     rRNA gene libraries from the stools of 4 patients with first-time CDI and 3 patients with     recurrent CDI. Based on 16S rRNA gene classification, they found that the fecal microbiomes     of patients with an initial episode of CDI were similar at the phylum level to healthy     subjects (i.e., the majority of sequences belonged to dominant fecal phyla Bacteroidetes and     Firmicutes), while a major reduction or loss of Bacteroidetes was observed in patients with     recurrent CDI. The loss of the Bacteroidetes was accompanied by the expansion of other phyla,     including Proteobacteria and Verrucomicrobia, which are normally minor constituents of the     fecal microbiota. Khoruts et al. (2010) compared the microbiota of a patient with recurrent     CDI before and after FMT by using terminal-restriction fragment length polymorphism and     clone-based 16S rRNA gene sequencing. Before transplantation, the patient's microbiota were     deficient in members of Bacteroides and instead were composed of atypical fecal genera such     as Veillonella, Clostridium, Lactobacillus, Streptococcus, and unclassified bacteria similar     to Erysipelothrix. Two weeks after infusion of donor fecal suspension, the bacterial     composition of her feces approached normal and was dominated by Bacteroides sp. strains.      In 1989, Tvede and Rask-Madsen used a combination of nine normal fecal organisms to treat 6     patients with chronic relapsing C. difficile diarrhea. These investigators cultivated 10     strains of bacteria, including Enterococcus (Streptococcus) faecalis (1108-2), Clostridium     innocuum (A27-24), Clostridium ramosum (A3I-3), Bacteroides ovatus (A40-4), Bacteroides     vulgatus (A33-14), Bacteroides thetaiotaomicron (A33-12), Escherichia coli (1109), E. coli     (1108-1), Clostridium bifermentans (A27-6), and Blautia producta (Peptostreptococcus     productus) (1108-2) in broth for 48 h to a concentration of approximately 10 to the 9th power     bacteria/mL. Two mL from each bacterial culture were admixed with 180 mL saline that had been     pretreated in an anaerobic chamber for 24 h; the bacterial suspension was then instilled     rectally. This procedure was followed promptly by a decline of C. difficile to undetectable     levels by culture and the loss of detectable toxin from the stools. Normal bowel function was     restored within 24 hours, and abdominal symptoms disappeared. Stool cultures and toxin assays     for C. difficile remained negative during a year of follow-up. It is especially important to     note that feces from none of the 6 patients contained Bacteroides sp.   "
108307|NCT01868360|"     The cornea is the clear front part of the eye. Corneal neovascularization, the excessive     growth of blood vessels into the cornea, is a sight-threatening condition. Corneal     neovascularization is also a well recognized risk factor for corneal graft failure. The     current standard of care to prevent graft rejection includes use of topical steroids and     medicines that suppress the immune system. These medicines do not address corneal     neovascularization. The purpose of the study is to establish the safety and potential     efficacy of subconjunctival injections of aflibercept (EYLEA® , marketed by Regeneron)     injection in inducing regression of blood vessels growing into the cornea and promoting graft     survival.      This study is being conducted by Dr. Balamurali Ambati at the Moran Eye Center.   "
108308|NCT01868347|"     Analysis of the specific elastance during general anesthesia in patients treated with RARP     (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive     strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of     pneumoperitoneum and trendelenburg position.   "
108309|NCT01868334|"     The purpose of this study is to test whether or not the 4 Pillars Toolkit increases adult     Influenza, pneumococcal polysaccharide vaccine (PPSV), tetanus, adult diphtheria and     acellular pertussis vaccine (Tdap/Td) vaccination rates. The vaccines are all FDA licensed     vaccines and to be used according to national guidelines. The investigators will conduct a     randomized cluster trial of this toolkit in diverse primary care practice with electronic     medical records (EMRs).   "
108418|NCT01866904|"     THis study is intended to provide contemporary data on the burden of disease in patients 1 to     3 years post-MI, including a description of patient characteristics, current treatment     patterns, rate of major CV events, and healthcare resource utilization in a 'real world'     patient population at high atherothrombotic risk.   "
108393|NCT01867242|"     This is a multi-center trial involving the University of Minnesota, Ohio State University     Comprehensive Cancer Center, and Roswell Park Cancer. Cigarette smokers who are eligible will     enter a Camel Snus sampling phase. Smokers interested in continuing with the study after the     sampling phase will undergo a 2 week baseline assessment phase and will then be randomized to     one of the five experimental conditions for 8 weeks. Tobacco use patterns, subjective     responses to product, and nicotine and toxicant exposure will be assessed.   "
108394|NCT01867229|"     Relation between chemotherapy and amennorhea   "
108310|NCT01868321|"     The purpose of this international, multicenter study is to determine ventilation practice and     outcomes of intubated and ventilated intensive care unit (ICU) patients. Ventilation     characteristics and outcomes will be compared between patients without the acute respiratory     distress syndrome (ARDS), patients at risk for ARDS, and patients with mild, moderate or     severe ARDS.      Participating centres worldwide will include adult patients undergoing mechanical ventilation     in the ICU during a 7-day period. Patients data will be collected during the first 7 days in     the ICU, or until ICU discharge. Follow up is until day 90. Primary endpoint is the tidal     volume size used during mechanical ventilation. Secondary endpoints are development of ARDS     in patients without ARDS at the onset of mechanical ventilation, worsening of ARDS in     patients with ARDS at the onset of mechanical ventilation, pulmonary infection, other     pulmonary complications, need for tracheostomy, extra-pulmonary complications, duration of     ventilation, length of ICU and hospital stay, and ICU, hospital and 90-day mortality.   "
108311|NCT01868308|"     Our objective is to investigate the predictive value of a panel of biomarkers associated with     two biologically plausible pathways of preterm birth: membrane breakdown and cervical     remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin,     and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a     prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm     birth in an effort to better risk stratify this cohort.   "
108312|NCT01868295|"     Tooth loss and sleep problems are common conditions in elders. Tooth loss can influence sleep     quality by changing the shape of the lower face and upper airway. While some studies suggest     that sleeping without dentures can worsen sleep quality in toothless elders, others suggest     the opposite. Consequently, there are currently no evidence-based practice guidelines     regarding whether dentures should be used at night, and dentists and doctors do not know how     to properly advise their patients on these issues. To address this knowledge gap, over the     past 5 years we have carried out research examining the quality of sleep of a group of     edentulous elders. In addition, we conducted a pilot study to examine the link between     night-time denture wear and sleep. Our results indicate that edentulous elders who wore their     dentures at night had high levels of daytime sleepiness. Furthermore, use of dentures at     night seemed to increase the risk of apneic events in those elders who had mild sleep     disturbance. While intriguing, these results require confirmation in larger samples. In line     with our previous research, the aim of the proposed study is to produce reliable evidence     that clinical practice guidelines could be based on and which could be used by dentists and     doctors who treat toothless elders.      We will enroll 70 toothless elders who will be randomly assigned to wear and not wear their     dentures at night for two periods of 30 days. Sleep studies will be conducted at the homes of     participants. The participants will also be asked to respond to questions on sleep quality     and oral health-related quality of life. Ultimately, the results of this study will help     improve the health and quality of life of millions of elders in Canada and around the world.   "
108313|NCT01868282|"     Patients scheduled to undergo knee arthroscopy with anterior cruciate ligament repair with     graft from the ipsilateral hamstrings and gracilis will be randomized to one of three groups.     All patients will receive subsartorial saphenous nerve block. Along with this, Group 1 will     receive perihamstring local anesthetic infiltration (Hamstring block), Group 2 will receive     blockade of the anterior division of obturator nerve and Group 3 (control group) will receive     sham injections of hamstrings and anterior division obturator nerve. All patients will     receive co-analgesics for home discharge. The study will evaluate the efficacy of     subsartorial saphenous nerve block alone or in combination with either hamstring block or     obturator block with regards to postoperative analgesia especially the donor site pain and     total analgesic consumption.   "
108314|NCT01868269|"     The OMS/DES study is a multinational European Trial for Children with the Opsoclonus     Myoclonus Syndrome / Dancing Eye Syndrome.      This trial brought on the way by specialists of the EPNS (European Paediatric Neurology     Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN     (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma).      This protocol will investigate an escalating treatment schedule starting with a     corticosteroid standard treatment with dexamethasone pulses (first step), which is followed,     if response has been inadequate after 3 months of treatment, by the addition of CP (second     step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third     step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES     severity.   "
108315|NCT01868256|"     -  Objectives: The primary objective of this study is to evaluate the safety of an early          discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI),          treated with primary percutaneous coronary intervention (PPCI), compared to a          conventional strategy.        -  Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical          trial. The investigators will compare an early discharge strategy (≤72 hours) with a          conventional strategy (discharge according to treating physician's criterion). Inclusion          criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24          hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular          tachycardia or fibrillation, asystole, pulseless electrical activity, advanced          atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or          septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding          (according to the GUSTO criteria), complications related to vascular access of the          procedure, acute kidney failure, infection, heart failure. Sample size will be 1558          subjects (n=779 per group). The investigators will study demographic, clinical,          biochemical, echocardiographic and angiographic variables. The primary endpoint will be          a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias,          stroke and severe bleeding. The secondary endpoint will include each of the items of the          primary endpoint and quality of life and functional capacity questionnaire SF-36.          Finally, the investigators will analyze the degree of compliance with the European          Society of Cardiology guidelines on STEMI and the rate of hospitalization-related          complications. Follow up will be at 30 days.   "
108316|NCT01868243|"     DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be     observed in this study is intracardiac thrombus. There are no formal primary or secondary     clinical efﬁcacy or safety outcomes because it is a pilot study.   "
108338|NCT01867957|"     1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective          in preclinical studies.        2. OBJECTIVE           - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy          male volunteers.        3. STUDY DESIGN             -  single-blinded             -  randomized             -  placebo controlled             -  phase 1 study   "
109690|NCT01850433|"     The primary aim is to develop, and test the feasibility, of a novel and protocol-based     cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered     via the Internet.   "
108317|NCT01868230|"     The overall goal of this randomized controlled trial is to test the efficacy of a culturally     and linguistically modified, individually tailored lifestyle intervention to reduce excess     gestational weight gain (GWG), increase postpartum weight loss, and improve maternal     metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the     impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum     biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin),     3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4)     offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and     5) to evaluate the cost-effectiveness of the intervention per average incremental improvement     in the outcome variables. Overweight/obese Hispanic women will be recruited in early     pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150)     or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will     utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally     adapted for Hispanics and shown to be efficacious in our previous controlled trials in this     ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed     print-based materials) will be used to deliver the intervention during pregnancy (~12 wks     gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum); follow-up     will continue for one year postpartum. Targets of the intervention are to achieve Institute     of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical     activity through increasing walking and developing a more active lifestyle; and reduction in     total calories by following a balanced healthy diet in compliance with American Diabetes     Association guidelines. The intervention draws from Social Cognitive Theory and the     Transtheoretical Model and includes strategies for partner and/or family support to address     the specific social, cultural, and economic challenges faced by underserved Hispanic women.     Measures of compliance will include actigraphs and Hispanic food frequency questionnaires.     The proposed project builds upon the expertise of the investigative team in conducting     randomized controlled trials of exercise interventions among Hispanic pregnant women (R01     DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18     DK0658850) and can readily be translated into clinical practice in underserved and minority     populations.   "
108318|NCT01868217|"     -  To Investigate the Prevalence of Capsular Bag Distention Syndrome        -  To Analyze Influencing Factors of Capsular Bag Distention Syndrome   "
108319|NCT01868204|"     Adoption, twin and family studies have reported that obesity has a strong heritable component     and in particular, it has been suggested that BMI in adults is due to genetic influence     rather than shared family environment. Binge eating in obese patients was described.     Therefore, it has been proposed that binge eating disorder (BED) may contribute to obesity in     some individuals.      Pharmacological studies reported that topiramate plays an important role in the treatment of     binge eating disorder. It has been observed improvement of co-occurring binge eating disorder     in patients receiving topiramate for treatment of mood disorders. In addition, topiramate was     associated with anorexia and weight loss in clinical trials with epilepsy patients. Also,     topiramate has been demonstrated efficacy in pilot and controlled studies for binge eating     disorder (BED) associated with obesity. Genetic studies will be important to elucidate the     mechanism by which putative susceptibility variation in candidate genes influences in     pharmacological improvement of binge eating disorder in obese patients treated with     topiramate.      Connecting drug response with relevant functional DNA variants and differences in brain     regions represents the ultimate goal for pharmacogenetic research playing an important role     in advancing this understanding. The use of brain imaging combined with genetics can aid in     understanding the pathophysiological mechanism of the disease. Additionally, brain imaging     has the ability to bridge between preclinical research and human pharmacological studies.      This will be a naturalistic clinical study designed to analyze the effect of genetic variants     and neurofunctional brain areas associated with food craving in patients with obesity and     binge eating disorder responders to topiramate.      Hypothesis: The use of topiramate in obese subjects with binge eating disorder is associated     with a differential gene variants and different activation brain areas in subjects that     showed a reduction of food craving and weight lost.   "
108320|NCT01868191|"     The aim of the present study is to assess before, as well as 6 and 12 months following a     therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density     (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes     mellitus and diabetic sensomotoric neuropathy.   "
108321|NCT01868178|"     The aim of this study was to estimate the relationship between BIS and Spectral Entropy     values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.   "
108322|NCT01868165|"     Older adults are at increased risk of high blood pressure and cognitive decline. High blood     pressure itself also increases risk of cognitive decline. A particular type of blood pressure     lowering drug (a calcium channel blocker(CCB)) may lower risk of dementia in younger adults     but there is no clear evidence of it's impact in those >=80. It is important that we know     whether CCB use impacts on cognitive function in this age group. This study will compare     change in cognitive function in those taking CCBs to those not taking CCBs.   "
108323|NCT01868152|"     This study aimed to find a quick and timely way to predict the individual variation of     efficacy of opioid analgesic during the operation and postoperative analgesia in Chinese     patients undergoing elective surgeries. Methods: female patients receiving elective surgery     under general anesthesia were recruited into this study. At the time of routine intravenous     anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect,     effects on Narcotrend index, sedative effect, effects on respiratory system, and aslo effects     on cardiovascular system. Then we record the consumption of of opioid analgesic during the     operation and postoperative analgesia. Also we record the side effect of the opioid     analgesic.   "
108324|NCT01868139|"     The goal of this study is to evaluate the safety and efficacy of endoscopic spray cryotherapy     using the CSA Medical, Inc. truFreeze System for patients with previously untreated     early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy including     surgery, chemotherapy, radiation therapy, and endoscopic resection.      It is hypothesized that one of the two following outcomes will occur:        1. Complete response to therapy: complete tumor eradication confirmed through histologic          examination of biopsy specimens from the targeted esophageal tissue site;        2. Stable disease: tumor remission is not attained, but disease progression is halted.   "
108325|NCT01868126|"     The purpose of this study is to investigate the safety and efficacy of four concentrations of     DE-117 ophthalmic solution.   "
108326|NCT01868113|"     The purpose of this study is to find out whether adjunct treatment with inhaled     corticosteroids lead to faster improvement and reduce mortality of children under 5 years of     age admitted to hospital with ALRI.   "
108327|NCT01868100|"     Advanced cancer has an adverse effect in virtually all dimensions of patients' lives     (physical, psychosocial, spiritual, familial, role function). One of the less frequently     explored effects of cancer is its impact on personal finances and the contribution of     financial-related distress to overall suffering and quality of life. Financial issues have     been recently found to be the second most frequent source of distress identified by cancer     patients in a community cancer center context (22%).      In the context of continuous increased health care costs, it is likely that the frequency of     health care related financial problems will keep rising. The relative contribution of these     adverse financial events in advanced cancer patients to overall patient distress is not well     assessed and this is particularly true in France. The main objective of this work is to     determine the association between financial distress and quality of life of patients with     advanced cancer in a Public General Hospital and in a Comprehensive Cancer Center. A     secondary objective is to characterize the frequency and intensity of financial distress     reported by French cancer patients and their impact on their quality of life.   "
108330|NCT01868061|"     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will     evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease     remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at     least one second controller medication. Participants will be randomized in 1:1:1 ratio to     receive double-blind treatment with either lebrikizumab (high or low) or placebo,     administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their     standard-of-care therapy. This will be followed by a 52-week double-blind active treatment     extension. Participants who were assigned to placebo during the placebo-controlled period of     the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams     (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is     104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.   "
108331|NCT01868048|"     The purpose of this study is to determine the effective dose range and to demonstrate a     non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity     due to multiple sclerosis.   "
108332|NCT01868035|"     This is a multicenter study for the long-term follow-up of surviving patients who are     expected to complete or who have completed at least two years of follow-up after treatment     with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or     CP-99-036. All patients will be assessed for survival and disease status, including     subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term     safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH)     level and a complete blood cell (CBC) count with a differential and platelet count will be     obtained annually. Additionally, patients who remain in long-term response following Iodine I     131 Tositumomab treatment will be followed for response and progression.   "
108333|NCT01868022|"     This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with     malignancies with abnormal dependence on FGF pathway signaling. Combination doses of     GSK3052230 with standard of care chemotherapy in the first and second line or greater setting     of metastatic squamous non-small cell lung cancer (NSCLC) and first line malignant pleural     mesothelioma subjects will be studied in the 3+3 dose-escalation design. This will be a     multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase IB     study designed to evaluate the safety, tolerability and preliminary activity of GSK3052230 in     combination with paclitaxel + carboplatin (Arm A), in combination with docetaxel (Arm B), or     in combination with pemetrexed + cisplatin (Arm C). Approximately 70 subjects will be     enrolled in the study (approximately up to 120 may be enrolled).   "
108334|NCT01868009|"     Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months     will be screened to participate in the study. Subjects will have an equal chance of being in     any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA     inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS     inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other     group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice     daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period     (once daily for 5 to9 days). At the end of the second period, subjects will complete the     study by answering 7 questions to assess their preference of device attributes and dosing     regimens between the two inhalers.      The null hypothesis for device preference for a specific attribute is that 50% subjects     express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in     that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA     is unity.      The null hypothesis for dosing regimen preference is that 50% subjects express a preference     of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice     daily dosing or have no preference).   "
108335|NCT01867996|"     This will be a randomized single sequence open label study. This study is designed to     determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics     (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of     screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and     the total duration of study participation for each subject will be approximately 8 weeks.     During the treatment period, subjects will be admitted to the clinical research unit the day     before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All     subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min),     followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On Days     3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects will     receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs plus     a 600 mg dose of EFZ.   "
108336|NCT01867983|"     This randomized controlled trial compares the effectiveness for both smoking cessation and     weight control of two alternative combined interventions offered via telephone quitline, as     compared to standard of care quitline treatment addressing cessation alone. The interventions     to be compared are cessation treatment alone versus cessation treatment combined with weight     control treatment added either simultaneously or sequentially.   "
108337|NCT01867970|"     Rationale: Physical activity is an important factor for a healthy lifestyle. Although     physical activity can delay complications and decrease the burden of the disease in     chronically ill persons, their level of activity is often far from optimal. Many     interventions have been developed to stimulate physical activity, with disappointing results.     New in this field is the use of technology. Human persuasion (for example guidance by a     practice nurse) can be enhanced by technological persuasion. Therefore a monitor and feedback     tool, consisting of an accelerometer linked to a smart phone and webserver, has been     developed and tested.      Objective: The main objective of this study is to measure the effects of the monitoring and     feedback tool embedded in a Self-management Support Program on physical activity. The     secondary objective is to measure the effect on self-efficacy, quality of life and health     status. In addition a process evaluation will be conducted.      Study design: A three-armed cluster randomised controlled trial will be conducted with 240     patients from 24 general practices. Randomisation level is the practice. The following     conditions will be compared: 1) Tool and Self-management Support Program; 2) Self-management     Support Program; 3) Care as usual. Outcome measures will be measured at t0 (before the start     of the intervention), t1 (after 6 months, at the end of the intervention) and t2 (after 9     months).      Study population: 120 People with COPD and 120 people with Diabetes type 2 (aged 40-70)     treated in primary care will be included from 24 GP practices.      Intervention: Spread over a period of six months patients in condition 1 and 2 have to visit     the practice nurse for 3-4 times for physical activity counselling. Specific activity goals     will be set that are tailored to the individual patient's preferences and needs. On top of     this, patients in condition 1 will be instructed to use the monitoring and feedback tool in     daily life. Patients in condition 3 will not be exposed to any intervention.      Main study parameters/endpoints: Primary outcome: physical activity measured with a physical     activity monitor (PAM). Secondary outcomes: quality of life, general self-efficacy, exercise     self-efficacy and health status.   "
108339|NCT01867944|"     The primary aim of this study is to test a non-medicinal technique for chronic constipation.     The core of the technique is to have subjects repeatedly press on and massage their perineum     before defecation to fragment and soften the stool before it passes the lower rectum and     anus. The technique will be evaluated as a complementary treatment to standard treatment of     constipation (patient educational materials about treatments such as stool softeners,     laxatives fiber supplements, and increased exercise). Although this technique has been     studied for other conditions (for example in pregnant women to prevent birthing-related     injuries), and it is recommended anecdotally by some physicians, this would be the first time     it will be studied for chronic constipation in a randomized, controlled clinical trial.      $50 dollars in compensation is provided for about an hour of participant's time.   "
108340|NCT01867931|"     The purpose of this study is to characterize and compare epithelial damage in patients with     erosive esophagitis and non-erosive reflux disease.   "
108341|NCT01867918|"     In this study the investigators will include colo-rectal cancer (CRC) patients starting last     line of standard palliative chemotherapy. Eligible patients include patients with KRAS     mutation starting line or KRAS wild type starting line treatment. Standard treatment today     for these patients is chemotherapy only and median overall survival (OS) is about 10 months.     The hypothesis is that local treatment in addition to systemic treatment will increase time     to progression, progression free survival and overall survival compared to patients who     receive systemic chemotherapy only. The investigators experience with local treatment of     liver metastases in CRC patients is that side-effects of treatment in general are minor,     although gastric bleeding have been observed after stereotactic body radiation therapy.   "
108342|NCT01867905|"     Sepsis is a significant cause health care expenditure and carries an extremely high rate of     morbidity and mortality if not treated appropriately. From 1979 to 2000, sepsis resulted in     over 10 million admissions to hospital in the United States with a mortality rate of 17.9 to     27.8 percent. In Canada, it is estimated that the incidence of sepsis from 2008-2009 was     103.3 per 100,000 per year.      Advances in the multifaceted management of sepsis in recent years have resulted in improved     clinical outcomes. However, the cornerstone of sepsis management relies on the prompt     administration of appropriate antibiotics. Current clinical practice suggests that antibiotic     administration can be delayed up to 45 minutes in order to obtain blood cultures, whose     results have a profound impact on the type and duration of antimicrobial therapy.     Unfortunately, this recommendation is based on very little evidence and the investigators     have found that potential life-saving treatment is often delayed in order to abide by it.     Furthermore, recent data suggest that mortality could be increased by approximately 5% by     delaying antibiotic administration for that time period.      The investigators therefore wish to organize a prospective, multi-centre trial in order to     identify the effect of antibiotic administration on blood culture positivity in patients     presenting with severe sepsis or septic shock. Other objectives will be to elucidate which     patient factors, including age, co-morbid conditions and clinical presentation, as well as     antibiotic choice will affect blood culture results.      This study will be conducted in the emergency departments at St. Paul's Hospital (SPH),     Vancouver General Hospital (VGH), and Lion's Gate Hospital (LGH). Patients identified for the     aforementioned conditions will be treated as per routine hospital protocol. If the patient is     deemed eligible for the study, a second set of blood of blood cultures will subsequently be     drawn ideally between 30 and 60 minutes after the administration of antibiotic therapy.     Subject demographic data will be collected pertaining to age, comorbid immunocompromised     conditions, vital signs, laboratory tests pertaining to end organ dysfunction, suspected     source of sepsis, the type antibiotics administered and the timing of antimicrobial     administration with respect to the second set of blood cultures taken.      Our hypothesis is that blood culture positivity in patients presenting with severe sepsis and     septic shock will not be altered significantly by antibiotic therapy. If so, our study would     strongly argue against delaying life-saving therapy and would thus greatly improve patient     care in our local emergency rooms. If incorrect, our study would be the first to demonstrate     the benefit of obtaining blood cultures before antibiotic therapy and would strengthen     current recommendations.   "
108343|NCT01867892|"     The primary end point is to evaluate the 9-month progression free survival rate and safety     profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent     chemoradiotherapy in locally advanced pancreatic cancer.      The secondary end points are to evaluate the disease control rate, overall survival time,     toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy     as well as the disease control rate after inductional chemotherapy alone in locally advanced     pancreatic cancer. Translational research including pharmacogenomic study and biomarker study     will also be done concomitantly.   "
108344|NCT01867879|"     The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with     advanced solid tumors.   "
108345|NCT01867866|"     The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a     component of TAS-102 with FTD alone.   "
108346|NCT01867853|"     To evaluate the performance of volume responsiveness in predicting the outcome of mechanical     ventilation weaning in critically ill patients.   "
108347|NCT01867840|"     In recent years, ion channels have emerged as new therapeutic targets for pain. Among these     channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are     directly activated by extracellular acidity, which is a major cause of pain. Indeed, many     painful conditions such as ischemia, inflammation, tumor development or tissue incision are     accompanied by tissue acidification. ASIC are excitatory ion channels that are expressed in     neurons, including nociceptive sensory neurons. In humans, the use of amiloride, a     nonspecific inhibitor of ASICs, has demonstrated their role in the perception of pain induced     by subcutaneous injections of acidic solutions. ASICs thus appear as new candidates capable     of mediating pain in humans. A growing number of data suggests that, in addition to protons,     ASICs may also be activated by one or more endogenous compounds produced during inflammation.     The purpose of this research project is to identify these compounds by testing the effects of     human inflammatory exudates on ASICs activity. The discovery of such compounds would     definitely validate ASICs as novel therapeutic targets for pain treatment in humans   "
108348|NCT01867827|"     The aim of the study is to train patients with Parkinson's Disease to increase activity in a     brain area that is involved in the control of motor functions with the use of a technique     called real-time fMRI neurofeedback (NF) along with regular physical exercise. This will be a     randomised and controlled clinical trial to evaluate the benefits of a novel treatment. The     investigators expect NF training along with physical exercise practise to better improve     motor functions compared to physical exercise alone.   "
108370|NCT01867541|"     Refractive outcome after cataract surgery mainly depends on the prediction of the intraocular     lens that is implanted in the eye during surgery.      Aim of this study is to measure the position of the lens capsule during surgery and to use     this measurements to improve post-operative refractive outcomes.   "
108623|NCT01864226|"     This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose,     placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive     either RO5545965 or matching placebo daily for 12 days.   "
108349|NCT01867814|"     Laparoscopic surgery is frequently associated with hemodynamic changes due to     pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and     occasionally they require active therapeutic interventions or even interruption of the     surgical procedure.      One of the main hemodynamic effects of PnP is a decrease in cardiac output due to reduction     of venous return and cardiac preload. Although it has been shown repeatedly that waveform     variables are good predictors of cardiac output response to volume loading, the prediction     hemodynamic response to decrease of preload is more complex.      The investigators hypothesize that waveform variables will predict cardiac output changes     resulting from PnP. Particularly, augmented values of waveform variables before PnP will be     associated with a larger decrease of cardiac output after establishing PnP.   "
108350|NCT01867801|"     The purpose of this Registry is creating a database management that allows continuous     monitoring characteristics, evolution, prognostic indicators and management of patients     undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of     clinical and interventional practice recommendations for diagnosis and treatment of coronary     disease and monitoring its evolution.   "
108351|NCT01867788|"     The Harvard Biomarker Study is a Harvard-wide, longitudinal case-control study designed for     discovering, replicating, and developing biomarkers for Parkinson's disease and Alzheimer's     disease. High-quality biosamples and high-resolution clinical phenotypes are tracked at three     visits over a two-year period for more than 2,000 individuals with early-stage PD, MCI/AD,     and controls without neurologic disease.      The present Ancillary Longitudinal CSF Collection Study (short HBS2) is an ancillary study     to the parent Harvard Biomarker Study. HBS2 is funded by the NINDS. In HBS2, 75 participants     are more intensely studied and followed over a three-year time period. Clinical data and     blood biospecimens are collected every six months and four annual CSF collections are     performed. Biospecimens and clinical data are deposited into the NINDS PD Biomarkers Program     (PDBP) Repository and the Data Management Resource (DMR) and are accessible through the PDBP     DMR website.   "
108352|NCT01867775|"     The purpose of this study is to determine whether mirtazapine is effective in the treatment     of sleep disorders in Alzheimers disease.   "
108353|NCT01867762|"     The purpose of this study is to assess the effectiveness and safety of JNJ 49095397 in     participants with symptomatic moderate to severe chronic obstructive pulmonary disease     (COPD).   "
108354|NCT01867749|"     The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who     meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to     demonstrate the feasibility of the proposed recruitment methods and research design, of the     therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group     treatment.      The investigators would like to examine preliminary evidence for the following hypotheses:        -  Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD          following perinatal loss than will Coping with Depression (CWD).        -  Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and          reduced depressive symptoms relative to CWD.        -  Perinatal-loss specific IPT-G will result in increased social support and social          functioning, reduced couple distress, and reduced grief relative to CWD.   "
108355|NCT01867736|"     A prospective, multicentric, randomized controlled trial to assess the safety and performance     of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18     PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the     infrapopliteal arteries.   "
108356|NCT01867723|"     Being diagnosed and treated for cancer is usually associated with severe side effects and     symptoms. Cancer patients can have difficulty to manage the symptoms as a result of treatment     which may cause i) an interruption or cessation of cancer treatment ii) can have a negative     impact on patients' quality of life (QoL). Family caregivers (FCs) of cancer patients are     often the primary source of social and emotional support for patients, and play major roles     in how well patients manage with the consequences of illness and treatment. Thus, FCs are     clinically important, since supporting FCs indirectly supports patients.      To help both cancer patients and their FCs to manage their symptoms, our center has developed     WebChoice now called Connect, an internet based support system that extends traditional     health services into cancer patients' homes. Connect provides individualized symptom     management support, illness relevant information, and communication with a clinical nurse     specialist in cancer care, as well as with other cancer patients and their FCs over the     Internet. The objectives of this interdisciplinary research project are to test main and     interaction effects of providing Connect to patients, to FCs or both simultaneously on 1)     primary patient outcomes in terms of symptom distress, QoL, depression, fatigue and sleep 2)     Primary FC outcomes in terms of symptom distress, QoL, depression, fatigue, sleep and FC     burden 3) Secondary, or intermediate, patient and FC outcomes in terms of self-efficacy     social support, and self-reported health care utilization.   "
108357|NCT01867710|"     The purpose of the study is to determine the safety and clinical benefit of the combinations     of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer     patients. Prednisone will be given at one of three different dose schedules. Dexamethasone     will be given at one dose schedule. This will include looking at what side effects occur and     how often they occur. In addition the impact of the study drug on quality of life and pain     will be evaluated. The study will also collect data on subsequent treatment of patients after     they come off the study drug (up to a maximum of 5 years after the study starts). By     analyzing blood samples, the study aims to identify if some markers could help to understand     if the treatment with abiraterone is effective and also help to understand if patients can     become resistant.   "
108391|NCT01867268|"     -  Purpose of study : to determine the preventive effect of acetazolamide administration,          prone positioning, and the combination of both following the neurosurgical interventions          in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound          dehiscence.        -  Sample size: 144        -  intervention groups:             -  Group A: Acetazolamide administration for 10 days             -  Group B: prone positioning for 10 days             -  Group C: Acetazolamide administration and prone positioning for 10 days             -  Group D: no intervention        -  Period of study: Autumn 2012 to the end of winter of 2015   "
131174|NCT01568060|"     The purpose of this study is to collect safety information following routine vaccination with     Infanrix-IPV among infants and children in Korea.   "
108358|NCT01867697|"     Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating     FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in     patients with potential resectable KRAS wildtype metastatic colorectal cancer.      All patients will be randomized to biweekly cetuximab 500 mg/m2 in combination with arm A)     FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46     hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6     (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU     infusion of 2400 mg/m2 every 2 weeks) .      Primary objective: response rate (RECIST 1.1) in patients with with potential resectable KRAS     wildtype metastatic colorectal cancer.      Secondary objectives: Resection rate, PFS, OS, Quality of life, tolerability. Biomarker     evaluation to measure plasma biomarkers, Tumour blocks and sequential serum and plasma will     be collected to search for markers that may predict efficacy including respectability and     safety.   "
108359|NCT01867684|"     Stroke, head injury and other forms of brain injury are a major cause of physical,     psychological and social disability in the adult population. Psychological distress is common     following brain injury, but the evidence base for specific psychotherapeutic methods in this     population is limited, and standard treatment approaches may not be suitable. Recently there     has been a growing interest in positive psychology - the study of wellbeing, positive     emotions and characteristics, and personal growth. The investigators believe that positive     psychotherapy interventions may be beneficial after acquired brain injury, to reduce     psychological morbidity. Because such interventions have not previously been applied in this     population, the investigators propose to conduct a pilot randomised controlled trial to     examine the feasibility of a brief positive psychotherapy intervention in an out-patient     setting. This project will produce essential information to allow us to plan future     full-scale clinical trials in this area.   "
108360|NCT01867671|"     This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut     oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in     peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned     to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26     weeks.   "
108361|NCT01867658|"     The objective of this clinical study is to evaluate the safety of the Progel® PALS, including     the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks     in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic)     surgeries.      The data collected in this clinical study will supplement the Approved PMA P010047 Progel®     PALS product.   "
108362|NCT01867645|"     Critical illness polyneuropathy and/or myopathy (CIPNM) is a severe complication of critical     illness. Retrospective data suggest that early application of IgM-enriched intravenous     immunoglobulin (IVIG) may prevent or mitigate CIPNM. Therefore, the primary objective was to     assess the effect of early IgM-enriched IVIG versus placebo to mitigate CIPNM in a     prospective setting.   "
108363|NCT01867632|"     The goal of the present study is to definitely determine whether the use of acellular dermal     matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation.     Although individual studies have described promising advantages to its use in cleft palate     surgery, no consensus currently exists. Without concrete evidence, one must question the     whether the increased cost, time and potential patient risk (human derived tissue) to     patients justifies its use in primary cleft palate repair.   "
108364|NCT01867619|"     The primary objective of the phase II study is to assess the objective (CR+PR) response rate     at a maximum tolerated dose (MTD) of Lomustine in combination with Temozolomide and     Thalidomide after the first cycle (8 weeks) in patients with metastatic melanoma in the     brain. Secondary objectives include the evaluation of objective response in the extracranial     metastases, duration of response and overall survival.   "
108365|NCT01867606|"     This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein     isolate works in improving quality of life and post-operative recovery in patients with     cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin     may help provide nutrition to patients who are not able to eat or digest ordinary food. This     may improve the quality of life of patients with gynecological cancer and help them recover     more quickly from surgery.   "
108366|NCT01867593|"     This research study is a prospective pilot study. The purpose of a pilot clinical study is to     obtain preliminary data to support the reason for doing a larger clinical trial on testing     the clinical effectiveness of an investigational intervention. Investigational means that     the role of MET-PET scans is still being studied and that research doctors are trying to find     out more about it. It also means that the FDA has not approved this intervention for your     type cancer.      In this research study, the investigators are evaluating whether or not MET-PET scans have     value in predicting response to standard chemoradiation therapy in participants with     newly-diagnosed glioblastoma. A standard treatment for glioblastoma is treatment with a     combination of radiation therapy and chemotherapy with the drug temozolomide.      In PET scans, a radioactive substance is injected into the body. The scanning machine finds     the radioactive substance, which tends to go to cancer cells. With standard PET scans, the     radioactive substance used is FDG. FDG goes to many areas of the normal brain which makes it     difficult for use in distinguishing brain tumors from normal tissue.      For the PET scans in this research study, the investigators are using a radioactive substance     called MET, instead of the standard substance FDG. MET gets absorbed by cancer cells but not     by normal brain and therefore may be better than FDG in evaluating brain tumors and therefore     may be better than FDG in evaluating brain tumors and their response to treatment.      In this research study, participants will receive standard chemotherapy and radiation therapy     for glioblastoma as well as standard MRI scans. In addition, participants will undergo     L-[Methyl]-11C Methionine Positron Emission Tomography (MET-PET) scans twice. The first     MET-PET scan will occur after enrollment but prior to radiation therapy. The second MET-PET     scan will occur approximately one month after completion of radiation therapy.   "
108367|NCT01867580|"     The purpose of this study is to examine the effectiveness of the V.A.C.Ulta Negative Pressure     Wound Therapy System and V.A.C. VeraFlo Dressing System in wounds that require operative     debridement.   "
108368|NCT01867567|"     Women undergoing their first second or third cesarean section will be randomized into two     groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the     other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days     for both groups. The incision will be inspected at the time of staple removal. The 2 groups     will be compared for incision disruption and infection. Also, the women will be asked about     their satisfaction for time of bandage removal.   "
108369|NCT01867554|"     Intellectual disability (ID) occurs in 2 to 3 % of the general population but the cause is     identified only in 30 to 60% of cases.      The purpose of this study is to indentify genes involved in ID with new genetics tools     (SNP-arrays, next generation sequencing...) and establish genotype-phenotype correlations.   "
108371|NCT01867528|"     Small bowel obstruction is a common reason for surgical admission. Most common reason for     small bowel obstruction is adhesions, which account up to 70-80 % of small bowel     obstructions. Large proportion of adhesive small bowel obstructions may be treated     nonoperatively, but up to 50-60% may need surgical intervention. Current golden standard for     surgical intervention is open adhesiolysis. Recently, retrospective studies have provided     encouraging results of laparoscopic adhesiolysis for small bowel obstructions. However, no     prospective randomized trials have been carried out and retrospective series carries a high     risk for patient selection and bias. Although in general laparoscopy has been associated with     shortened hospital stay, less pain and reduced mortality, laparoscopic adhesiolysis for small     bowel obstruction has been reported to cause iatrogenic small bowel lesions up to 7% of     patients. Aim of the study is to compare open adhesiolysis to laparoscopic adhesiolysis. The     investigators hypothesis is that laparoscopic adhesiolysis is safe, will shorten the hospital     stay, and reduce mortality compared to open approach.   "
108372|NCT01867515|"     The purpose of this program of research is to understand the perception of the dynamic     spectral properties of speech by hearing-impaired listeners, with the long-term goal of     improving speech understanding by these individuals in adverse listening conditions. The     proposed research compares the performance of normally-hearing and hearing-impaired listeners     on measures of speech understanding in the presence of different types of signal distortion     and speech understanding of signals with enhanced spectral dynamics. A computational model     based on the amount of potential information available in speech will be used to quantify     differences in speech intelligibility due to hearing status and stimulus characteristics.   "
108373|NCT01867502|"     Exercise is considered a way to benefit the health of unhealthy and healthy individuals. This     is confirmed by different scientific researches, in which people who participated improve     their health. The present study will be conducted to test the hypothesis that vildagliptin     associated with metformin may have more impact in improving glucose variability after a     sub-maximal exercise test, as compared to glibenclamide. Our general aim will be to evaluate     glucose variability after the submaximal exercise test under the treatment with vildagliptin     or glibenclamide. The specific aims of this study are to evaluate the oxidative stress,     endothelial function, metabolic and cardiovascular responses to exercise under the treatment     with vildagliptin or glibenclamide. All these responses are important in patients with     Diabetes Mellitus type II. Allied to the patient's routine treatment (metformin), they will     receive orally a second drug, to take in 12 weeks. The patients will be raffled to take one     of the two drugs that act on glycemia, that are called vildagliptin (50 mg of this drug twice     a day) and glibenclamide (5 mg once a day during the first week and later you will increase     to 5 mg twice a day). The metformin drug will continue be used.      Patients who meet the eligible criteria for the study will first make the test of the maximum     effort, to determination of peak oxygen consumption (VO2peak) and ventilatory thresholds.     Forty eight hours after this test, patients will be allowed to do the pre-drugs protocol that     will be given in three consecutive days as explained below.        -  Day 1: Begin a 24-hour urinary collection, perform vascular doppler ultrasound to          evaluate endothelial function and then the glucose sensor will be inserted          subcutaneously (begin continuous glucose monitoring system - CGMS evaluation);        -  Day 2: End the 24-hour urinary collection, submit to the submaximal test (blood          collection at baseline, 15 and 30 min of the session, and 60 min after recovery). On the          same day, the patients will begin 24h ambulatory blood pressure monitoring (24h-ABPM).        -  Day 3: Removal of the glucose sensor; end of the 24h ABPM, randomization. This same          protocol, except the randomization will be repeated at the end of the 12 week treatment.   "
108374|NCT01867489|"     This qualitative study explores how patients deal with the side effects from chemotherapy at     their home, what factors and ideas influence their symptom self-management and how     professional caregivers contribute to the management of their symptoms at home. Data are     collected through semi-structured interviews with adult patients treated with chemotherapy     and analysed using a Grounded Theory approach.   "
108375|NCT01867476|"     The purpose of this study is to determine the feasibility and accuracy of an automated     adherence monitoring system, and to compare the variance between urine and oral fluid     riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen     interval.   "
108376|NCT01867463|"     Background:      - Malaria is a disease that is spread by mosquitoes. Researchers are looking for a vaccine     that can prevent mosquitoes from transmitting malaria to people. They want to test a vaccine     called Pfs25-EPA/Alhydrogel that may help stop malaria parasites from developing in     mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites     from developing in the mosquito. As a result, the mosquito will not spread malaria to the     next person it bites. However, the vaccine will not directly prevent people vaccinated from     getting sick with malaria. Researchers want to test this vaccine in people who live in rural     Mali. To do so, the study will compare the symptoms and the blood tests of the participants     who receive either the study vaccine or a regular hepatitis B/meningococcal vaccine.      Objectives:      - To see if Pfs25-EPA/Alhydrogel is a safe and effective malaria vaccine.      Eligibility:      - Healthy volunteers between 18 and 45 years of age who live in Bancoumana, Mali.      Design:        -  Participants will be screened with a medical history, physical exam, and blood tests.        -  Participants will be separated into two groups. One group will have Pfs25-EPA/Alhydrogel          to test the study vaccine. The other group will have the regular Hepatitis B vaccine          series, meningococcal vaccine.        -  In the study vaccine group, participants will have either a lower dose or a higher dose.          For the lower dose, they will have two vaccine shots over 1 year. For the higher dose,          they will have four vaccine shots over about 14 months.        -  In the other vaccine group, participants will have the Hepatitis B vaccine series,          meningococcal vaccine according to the standard dose schedule.        -  All participants will provide regular blood samples for testing during the study.        -  Participants who develop malaria during the study will participate in evaluation of          transmission and parasite development of malaria parasite from the person to mosquito          via transmission assays. They will allow mosquitoes (that have no diseases) to bite them          in a controlled clinic setting. This will let researchers see if the vaccine can stop          the mosquitoes from carrying malaria to other people.   "
108377|NCT01867450|"     Background:      - Diesel fuel is the most commonly used fuel to power cars and trucks worldwide. However,     diesel exhaust fumes can have harmful effects on the body. Researchers are interested in     studying how diesel exhaust exposure can affect lung health. To study these effects,     researchers will look at employees of a diesel truck engine testing facility in China. Some     workers at this facility are exposed to high levels of diesel exhaust. This study will     compare tests and monitoring information from a group of highly exposed workers and a similar     group of unexposed comparable controls.      Objectives:        -  To study the effects of diesel exhaust on lung health.      Eligibility:        -  Participants will be drawn from a diesel truck engine testing facility and other          workplaces in China.        -  Individuals at least 18 years of age who work in workshops with diesel fuel.        -  Individuals at least 18 years of age who work in workshops that do not use diesel fuel.      Design:        -  Depending on what type of factory study subjects work in, participants will wear          personal air pumps and small badges on their clothing on one or more days. This          equipment will measure particles, chemicals, and other compounds in the air. This          information plus other information collected in the study including workplace practices          will be used to estimate exposure to diesel exhaust among study subjects.        -  Participants will provide a number of study samples. These samples include blood, urine,          and sputum. To collect other samples, participants will also have a mouth rinse, cheek          cell scrapes, and nasal cell scrapes. They will also have a physical exam.        -  Treatment will not be provided as part of this study. Participants will receive          financial compensation for participation in the study.   "
108392|NCT01867255|"     The purpose of the study is to determine whether a significant and predictable change in     bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.   "
108378|NCT01867437|"     Background:      - RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It     has helped to reduce body weight and improve insulin sensitivity in lab tests. However, it is     not fully known whether RM-493 causes weight loss by just decreasing appetite or by     increasing metabolism or both. Researchers want to see how RM-493 affects metabolism and     hormones that affect the metabolic rate. They also want to see how RM-493 affects appetite by     assessing feelings of hunger and fullness. They will study this drug in people who are obese     but are otherwise in good health.      Objectives:      - To see how RM-493 affects metabolic rate and appetite in obese but otherwise healthy     individuals.      Eligibility:      - Individuals between 18 and 50 years old who are obese (body mass index between 30 and 40     kg/m2) but are otherwise healthy.      Design:        -  The study consists of three phases. The first phase is the screening visit. The second          phase is an 8-day inpatient stay. The final phase is a follow-up phone call one week          after the end of the second phase.        -  Participants will be divided into two groups. One group will receive the study drug          first, followed by a placebo. The other group will receive the placebo followed by the          study drug. The study drug and placebo will be given under the skin for 3 days each by a          small device (OmniPod) that normally is used to give insulin to people with diabetes.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. They will also meet with a dietitian. The OmniPod device will          be demonstrated before use.        -  Participants will have the following procedures during their 8-day inpatient stay:        -  Daily exercise routine (walking on treadmill) after setting a comfortable pace (miles          per hour) during an exercise test        -  Wear physical activity monitors        -  Body composition study to measure amounts of fat and muscle        -  Calorie controlled study diet        -  Study drug/placebo dose through the OmniPod (Days 2 through 4 and 5 through 7)        -  Metabolic rate studies using a cart or the metabolic chamber        -  Daily blood samples        -  Urine collection for 24 hours        -  Questions about weight history and appetite        -  About a week after the inpatient stay, participants will have a followup phone call to          ask about any side effects from the study.   "
108379|NCT01867424|"     Background:      - Prostate cancer is the most common cancer type among men. Some prostate cancers respond to     hormonal therapy. However, some cell characteristics of other prostate cancers cause it not     to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast     agent used to help identify damaged liver tissue, can help tell these types of prostate     cancer apart. It may be able to identify if a man has a type of prostate cancer for which     hormone therapy may not work as well.      Objectives:      - To see if gadoxetate can help identify different types of prostate cancers during imaging     studies.      Eligibility:      - Men at least 18 years of age who have prostate cancer. Participants will be having surgery     to either remove the prostate or take tumor tissue samples.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected.        -  Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They          will receive gadoxetate during the MRI scan.        -  Participants who have surgery will have a sample of their tumor cells collected. Those          who have a biopsy will provide cells from this biopsy for study.        -  Treatment will not be provided as part of this study.   "
108380|NCT01867411|"     Background:      - Smoking is a difficult habit to quit, and some people find it more difficult to quit than     others do. Nicotine is the substance in cigarettes that makes smoking so addictive. Nicotine     changes some patterns of brain activity, and smokers have differences in brain activity when     compared to non-smokers. Some genes make it more likely that a person will become addicted to     smoking. Researchers want to study how nicotine interacts with genes and brain activity. This     may help develop better treatments to help people quit smoking.      Objectives:      - To develop a test of nicotine dependence, using brain activity and genetic analysis, which     may be useful in predicting success in smoking cessation and in the development of new     smoking cessation treatment targets.      Eligibility:        -  Main group: Current smokers between 18 and 55 years of age who are seeking treatment to          quit.        -  Comparison group: Current smokers between 18 and 55 years of age who are not seeking to          quit.        -  Comparison group: Healthy former smokers between 18 and 55 years of age.        -  Comparison group: Healthy nonsmoking volunteers between 18 and 55 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected.        -  The three comparison groups will have one magnetic resonance imaging (MRI) scan session.          They will have tests of thinking, concentration, and memory both inside the scanner, and          while sitting in front of a computer.        -  Current smokers who are trying to quit must be willing to undergo a course of nicotine          treatment that includes weekly counseling (for 12 weeks) and e-cigarettes. Participants          will attempt smoking abstinence and will have a total of 6 MRI scanning sessions. They          will do thinking, concentration, and memory tasks inside and outside of the scanner.        -  For smokers, the first scanning session will take place before they attempt to quit.          This will be a baseline scan. The second scanning session will take place 48 hours after          having their last real cigarette. After this scan, they will use electronic cigarettes          to help quit their habit.        -  After using e-cigarettes for two weeks, smokers will have a third scan session.. They          will then gradually taper their use of the electronic cigarettes over the course of          three weeks, at which point they will be nicotine abstinent.        -  After about 5 weeks of abstinence, they will have the fourth scan. The fifth scan will          be approximately 6 months after start of the study, and the final scan will take place          at about 1 year from the study start.        -  Smokers will continue to receive support on quitting smoking until the study ends at          about 1 year.   "
108381|NCT01867398|"     Background:      - Some children and teenagers have conditions known as conduct disorders. They often have     long-term chronic behavior problems, such as defiant behavior or violence. Conduct disorders     are often treated with antipsychotic medication. Researchers want to study two types of newer     antipsychotics (aripiprizole and risperidone) for children and adolescents with conduct     disorders. They will look at how these drugs affect brain activity. To do so, they will give     brain activity tests using magnetic resonance imaging (MRI). The tests will compare the     results from healthy volunteer children and teens to those of others with behavior problems.      Objectives:      - To see how atypical antipsychotics affect brain activity of children and teenagers with     conduct disorders.      Eligibility:        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and          are taking aripiprizole.        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and          are taking risperidone.        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and          are not taking an atypical antipsychotic.        -  Healthy volunteers between 10 and 18 years of age.      Design:        -  Participants will be screened with a physical exam and medical history.          Parents/guardians will be asked questions about their child s feelings, experiences, and          behavior. Participants will also answer questions about their feelings and moods.        -  This study will involve two visits. Each visit will involve MRI scanning.        -  At the first visit, participants will have memory and thinking tests. The tests will          involve making decisions or playing games. Some of these tests will use MRI scanning to          look at brain activity.        -  The second visit will be 3 to 5 months after the first visit. The tests from the first          visit will be repeated.   "
108382|NCT01867385|"     Background:      - Fatigue is a common and often disabling symptom in people with chronic liver disease. Its     causes are not well understood. Sleep disturbance may play a role in people with cirrhosis,     but these factors have not been studied in people with other stages of liver disease. This     study will look at the body's circadian rhythms (internal clock) to see if problems with     these rhythms can contribute to fatigue. It will look at the causes and mechanisms of fatigue     in people with chronic liver disease by comparing people with and without fatigue.      Objectives:      - To study reasons for fatigue in people with chronic liver disease.      Eligibility:        -  <TAB>Individuals at least 18 years of age who have chronic liver disease.        -  <TAB>Participants with or without fatigue may enroll.      Design:        -  Participants will be screened with a physical exam and medical history. They will have a          2-day inpatient stay for the study.        -  For the 7 days before the inpatient stay, participants will keep a sleep diary. They          will record any caffeine or alcohol consumption, medicines, exercise, and sleep or naps.          They will also wear an actigraph to measure their activity levels.        -  During the inpatient stay, participants will answer questions about fatigue and sleep          habits. They will have regular blood tests for 24 hours. Their body temperature will          also be monitored. During the night, they will have a sleep study to look at how well or          poorly they sleep.        -  Treatment will not be provided as part of this study.   "
108416|NCT01866930|"     To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment     with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1   "
108417|NCT01866917|"     Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for     obese women undergoing laparoscopic or robotic gynecologic procedures.   "
108383|NCT01867372|"     Background:      - Participants in the Baltimore Longitudinal Study of Aging are being studied to examine     changes in brain structure and function over time, and to determine if these changes can     predict the likelihood that an individual will develop thinking and memory impairments such     as Alzheimer s disease later in life. Imaging studies and neuropsychological testing have     been conducted on current participants, and new participants are being recruited to the     study. To develop better treatments and therapies for aging-related memory loss and other     disorders, researchers are interested in determining whether early prediction of thinking and     memory impairments are accurate and in evaluating factors that affect these predictions.      Objectives:      - To use imaging studies and tests of thinking and memory to determine early markers of     Alzheimer s disease and other cognitive impairments.      Eligibility:      - Current participants and new recruits to the Baltimore Longitudinal Study of Aging.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine tests.        -  Participants will have testing visits as directed by the study researchers. All          participants will have tests as part of their an initial enrollment in the study, and          may be asked to return yearly, 2 years later, or 4 years later for repeated tests.        -  At each visit, participants will have brain imaging scans (including magnetic resonance          imaging and/or magnetic resonance spectroscopy to measure brain structure and function,          and positron emission tomography to study blood flow in the brain) to evaluate brain          structure and function. Participants will also take tests of memory and problem-solving          skills.        -  Treatment will not be provided as part of this protocol.   "
108384|NCT01867359|"     Background:      - Researchers are interested in learning more about dementia and its causes. They want to     look at the genetic basis of dementia. Identifying genetic aspects of dementia may help     provide better tests and treatments for it. It may also show rare gene variants that can     cause or alter a person's risks for developing dementia. This study will look at people who     have dementia, their family members, and healthy volunteers.      Objectives:      - To study genetic influences on dementia.      Eligibility:        -  Individuals who have been diagnosed with dementia.        -  Family members of individuals who have been diagnosed with dementia.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants will be interviewed and answer questions about their medical history. They          will also provide general information on the relatives' medical histories.        -  Participants will provide a blood sample for genetic testing.        -  Participants will remain on the study for up to 10 years. They will have regular visits          to monitor their brain health and function.        -  Treatment will not be provided as part of this study.   "
108385|NCT01867346|"     Background:      - The Baltimore Longitudinal Study of Aging (BLSA) is a long-term study of human aging. To     see how the brain changes with age, researchers will study BLSA participants who are at least     60 years old. In particular, researchers are looking for early markers of possible     Alzheimer's disease and other conditions that cause memory loss. To do so, they will give     tests of memory and brain function, and stay in close contact with participants.      Objectives:      - To study cognitive changes that occur in normal aging and in people who develop memory     problems.      Eligibility:      - Individuals at least 60 years of age who are participating in the BLSA.      Design:        -  There are three parts to this study. These study procedures will be done under the usual          BLSA guidelines.        -  Participants will take paper and pencil tests. The tests measure skills such as          language, attention, memory, and problem solving. They will also ask questions about          emotions and feelings.        -  Participants will give the name and phone number of a person who knows them well and          sees them often. Researchers will ask this person to fill out questionnaires on the          effects of aging on the participant. These questions will monitor the participant's          memory and ability to function independently.        -  Participants will have regular phone calls between study visits. These calls will help          to keep their information up to date.        -  Participants will continue on this study for as long as they are able to participate.   "
108386|NCT01867333|"     Background:      - Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is     given after chemotherapy and surgery to help the body destroy the cancer cells. A new     possible way of treating prostate cancer is using a vaccine that may help stimulate the     immune system. It will help white blood cells recognize and kill the cancer cells in and     around the prostate. Researchers want to see whether this vaccine, given with enzalutamide,     is more effective at treating advanced prostate cancer than enzalutamide alone.      Objectives:      - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy     for advanced prostate cancer.      Eligibility:      - Men at least 18 years of age who have advanced castration-resistant prostate cancer.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies will be used to monitor the cancer before          treatment.        -  Participants will be separated into two groups. One group will have enzalutamide and the          study vaccine. The other group will have enzalutamide alone.        -  All participants will take enzalutamide once a day. They will take the drug during          4-week cycles of treatment.        -  Treatment will be monitored with frequent blood tests and imaging studies. Participants          will continue to take the study drug for as long as the cancer does not grow and the          side effects are not severe.        -  The vaccine group of participants will also have the new study vaccine. They will have a          single injection on the first day of the first study cycle. There will be regular          booster injections afterward. There will be one on day 15 of the first cycle, the first          day of the second cycle. The vaccine will then be given every 4 weeks for the next four          cycles, and then every 12 weeks (every 3 cycles) thereafter. Participants will continue          to have the study vaccine for as long as the cancer does not grow and the side effects          are not severe.   "
108387|NCT01867320|"     Background:      - Human T-cell lymphotropic virus type 1 associated myelopathy/tropical spastic paraparesis     (HAM/TSP) is an infection of the spinal cord. The infection is caused by a virus that has     been known to cause cancers like leukemia and lymphoma. It causes a weakening of the legs.     Researchers want to see if raltegravir, a drug for treating human immunodeficiency virus     (HIV), can be used to treat HAM/TSP. They will see if the drug can reduce the amount of virus     in the blood of people with HAM/TSP.      Objectives:      - To see if raltegravir can reduce the viral load of people with HAM/TSP.      Eligibility:      - Individuals at least 18 years of age who have HAM/TSP.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. Imaging studies will be performed. A lumbar puncture will also be          taken.        -  Participants will take the study drug twice a day for 6 months. They will note each dose          in a study diary, as well as any side effects.        -  At the 6-month visit, participants will stop taking the study drug. They will have a          physical exam and blood samples, as well as other tests.        -  Participants will have two further exams 9 months and 15 months after starting the study          drug. They will have a physical exam and blood samples, as well as other tests.   "
108388|NCT01867307|"     Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on     kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus     and healthy controls   "
108389|NCT01867294|"     This randomized phase II trial studies how well giving spironolactone works in preventing     rash in patients with advanced cancer receiving panitumumab and cetuximab. Spironolactone may     prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.   "
108390|NCT01867281|"     The purpose of this study is to determine the effect of aspirin desensitization on symptoms     and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).   "
139401|NCT01460017|"     The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer     procedure and may yield better results than trabeculotomy trabeculectomy approach.   "
108397|NCT01867190|"     This study will assess the safety and efficacy of intra-arterial infusion and intramuscular     injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) versus placebo     in patients with critical limb ischemia who have exhausted all medical and surgical     therapeutic options. The safety and tolerability will be evaluated by regular monitoring of     the general physical condition, vital signs, and the occurrence of AE and SAE, respectively.     Furthermore, the standard biochemical and blood variables (red and white blood cell counts,     Hb, Ht, platelets, sodium, potassium, chloride, calcium, phosphor, ASAT, ALAT, bilirubin,     total protein, albumin, AP, cholesterol (LDL,HDL), triglycerides, urea and creatinine,     immunoglobulins, HBA1c, C-peptide) will be checked before the treatment as well as 30 and 90     days after the treatment.   "
108398|NCT01867177|"     The purpose of this study is to conduct a cross-site evaluation of the Kaiser Permanente's     Community-based Interventions to Increase HIV Testing and HIV Care Utilization Program,     designed to support community-based interventions to reduce the number of new HIV cases and     to increase HIV care acquisition and maintenance in minority communities disproportionately     affected by the HIV epidemic. This effort builds on the President's National Strategy for HIV     Prevention and recent research documenting the importance and efficacy of test and treat     and treatment as prevention approaches. Hence, goals of this important and novel work will     focus on the following objectives:        1. identification of HIV infection among recently infected adolescents and adults        2. improved access to HIV care, particularly among newly diagnosed adolescents and adults      To achieve these objectives, the following outcomes are expected from grantee programs:        1. increased HIV testing among populations at risk for HIV        2. improved health care utilization among HIV infected adults and adolescents      This initiative has been undertaken by Kaiser to affect HIV at a population level via     community approaches to prevention, intervention and care in minority communities most     affected by HIV (e.g. gay, African American, and Latino communities). The University of     California, San Diego has developed and will oversee a cross-site evaluation of Kaiser     grantee programs funded under this initiative. Each site will have a treatment and comparison     group, and will conduct follow up surveys with their participants three and six months after     their interventions.   "
108399|NCT01867164|"     The purpose of this comparative study is to evaluate the efficacy of an ovule with triple     active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple     active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused     by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis     (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella     vaginalis and other anaerobic organisms and a decrease in lactobacilli).   "
108400|NCT01867151|"     Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and     multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or     gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected by     burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and     especially tongue burning sensation, deeply decreasing the quality of life of patients   "
108401|NCT01867138|"     The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to     vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial     sepsis probably caused by Coagulase-negative staphylococcus.      The investigators hypothesized that newborn infants with the presumptive diagnosis of     nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome     not inferior to that of those treated with vancomycin.   "
108402|NCT01867125|"     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will     evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease     remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at     least one second controller medication. Participants will be randomized in 1:1:1 ratio to     receive double-blind treatment with either lebrikizumab (high or low) or placebo,     administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their     standard-of-care therapy. This will be followed by a 52-week double-blind active treatment     extension. During double-blind active treatment extension period, all participants will     receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study     treatment is 104 weeks. After study treatment, all participants will complete a 20-week     safety follow-up.   "
108403|NCT01867112|"     Individuals of advanced age undergo both physical and cognitive deterioration. The aim of     this study is to explore the connection between level of physical activity and health     parameters, quality of life, and frailty.   "
108404|NCT01867099|"     Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients     do not respond favorably to medical therapy. Successful procedures are accomplished in the     majority of patients, but the outcome after many years of follow-up after ablation is     unknown.   "
108405|NCT01867086|"     This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with     carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells     obtained at the time of primary surgical debulking. Patients meeting eligibility criteria     will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30     minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7     cells/intradermal injection, once every 3 weeks.   "
108406|NCT01867073|"     OPB-51602 is a novel oral small molecule STAT3 inhibitor developed by Otsuka Pharmaceutical     Company, Ltd, and is currently undergoing clinical investigation at the National University     Health System (NUHS), Singapore. The proposed correlative pharmacodynamic and pharmacogenetic     biomarker study is initiated and funded by the investigators, and will be conducted in     conjunction with the extension phase I protocol of OPB-51602 in patients with advanced solid     tumours (Study code 266-09-801-01/ DSRB protocol B/09/514). All biomarker and pharmacogenetic     samples will be collected, stored and analysed at the local laboratory of the study site     (Cancer Science Institute, National University Health System, Singapore, Dr Boon-Cher Goh).   "
108638|NCT01864031|"     The association between alcohol consumption and cardiovascular disease (CVD) has mostly been     examined using broad endpoints or cause-specific mortality. The purpose of our study is to     compare the effect of alcohol consumption in the aetiology of a range of cardiovascular     disease phenotypes.   "
108407|NCT01867060|"     This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm     Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial     Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3     months, will detect significantly more cases of PAF than the ACER, used continuously for one     week.      A case-control sub-study will identify individuals with confirmed PAF, and matched     individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.      A further case-control study will assess markers of left atrial function in patients with PAF     and their matched controls.      Another case-control sub-study will determine the significance of frequent Atrial Premature     Beats (APBs) in the development of AF over a one year period.   "
108408|NCT01867047|"     The purpose of this study is to determine the effects of Angiotension Converting Enzyme     Inhibitors (ACE-I) during surgery and in the immediate postoperative period for patients     undergoing elective total hip or knee arthroplasty.   "
108409|NCT01867034|"     It is hypothesized that patients with low pre-PCI serum levels of sRAGE should receive DES     implantation and/ or procedures taken to increase serum levels of sRAGE and/ or decrease the     serum levels of AGE.      The purpose of this pilot study is to afford invasive cardiologists with additional evidenced     based information to guide their decision as to which patients should receive a BMS or DES     for coronary implantation.      The objectives of the study are to determine whether or not:        1. Patients with low pre-PCI serum levels of sRAGE who receive bare metal stents develop          restenosis        2. Patients with high pre-PCI serum levels of sRAGE who receive bare metal stents will have          reduced risk of the development of restenosis        3. Patients with low pre-PCI serum levels of sRAGE who receive drug eluting stents will          have an increased risk of the development of restenosis   "
108410|NCT01867021|"     Demonstrate non-inferiority of the post-vaccination (Day 22) Hemagglutination inhibition (HI)     Geometric Mean Titers (GMTs) of trivalent, inactivated, subunit influenza vaccine (TIV) over     the corresponding GMTs of the comparator vaccine for all three strains, in healthy adults     aged 50 years and above.      Demonstrate non-inferiority of the percentages of subjects achieving seroconversion in     antibody titers at Day 22 in the TIV group over the corresponding percentages of subjects in     the comparator group for all three strains, in healthy adults aged 50 years and above.   "
108411|NCT01866995|"     The purpose of this study is to investigate the efficacy of Phytotherapy Raylis (Ginseng     Root Powder 50 mg, False Ginseng Root Powder 50 mg, Codonopsis Root Powder 50 mg, Astragalus     Membranaceus Root Powder 50 mg, Epimedium Alpinum Herbal Extract 100 mg) In Congestive     Processes Of The Pelvic Organs (Prostatostasis) In Congestive Processes Of The Pelvic Organs     (Prostatostasis)   "
108412|NCT01866982|"     Premature babies can be very sick and have bleeding in the brain. Giving babies more blood     before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been     shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion     to the brain. However, some studies suggest that delayed cord clamping may not increase     hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical     cord may give more blood in babies delivered by Cesarean Section may improve perfusion and     reduce bleeding in the brain.   "
108413|NCT01866969|"     This clinical trial studies quality of life in caregivers of hospitalized older patients with     cancer.   "
108414|NCT01866956|"     The KSADS-COMP will facilitate identification of comorbid psychiatric and substance use     diagnoses frequently missed in clinical practice, and improve adolescent treatment outcomes.     The self-administered version of the KSADS-COMP can also be used cost-effectively in schools     and juvenile justice settings where there is a growing interest in early identification and     referral of youth in need of mental health services. The KSADS-Bridge assessment tool with     its RDoC neurocognitive tasks, when completed with the self- or clinician administered     KSADS-COMP, will help to create cross-talk between the DSM and RDoC diagnostic perspectives,     and begin to generate a database on the relationship between RDoC constructs and treatment     outcomes across a range of diagnostic categories.   "
108415|NCT01866943|"     Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss,     requiring blood transfusions in some patients. The major cause of this blood loss is due to     surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies     and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that     reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form     has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical     procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic     acid has been associated with decreased blood loss in cardiac surgeries as well. Recently,     results from a prospective randomized study on the topical use of tranexamic acid in total     knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all     of the above into consideration we have proposed a study to evaluate effects of topical     application of tranexamic acid on postoperative blood loss and blood transfusion on patients     undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the     topical application of tranexamic acid on blood loss in patients undergoing a primary     unilateral total hip arthroplasty.   "
108419|NCT01866891|"     Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease     (PAD). This could lead wounds, infections then amputations or deaths by impairment of the     peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow     down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased     by the significant inactivity of the chronic hemodialysis patients. Recently, many studies     have shown several various favorable effects of the perdialytic physical activity. There is     currently no data about effects of the perdialytic activity on the lower extremity perfusion.     The aim of this clinical study is to show the impact of three months perdialytic cycling on     the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase     of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about     twenty patients.   "
108748|NCT01862601|"     This research study is being done to see how well the JetTouch Needle-Free Endoscopic     Injection System is able to deliver a solution safely into the bladder wall. The JetTouch     Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected     into the bladder without using a needle. It is hoped that this method will provide a reliable     and consistent method to deliver drugs into the bladder wall.   "
108420|NCT01866878|"     Sensory disorders in patients with multiple sclerosis are among the most common symptoms     encountered.      A functional impairment based on sensory disorders of the hand. The hand is a sensory organ     that transmits the cerebral cortex protopathic sensitive information, proprioceptive or     epicritiques. The view-hand association plays an important role in the understanding of the     environment. Its exploratory use remains an essential and voluntary basis. The process of     recognition of the object passes through manipulation, but operates instantaneously. The     brain is able to do a quick summary of the information it receives to determine the nature of     the manipulated object. The exploration takes a posteriori, the brain can then determine the     details component object (texture, shape, composition, temperature and weight).      Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous     electrical nerve stimulation (TENS) are not fully understood. Several theories underlying its     use as a neuromodulator of pain. The gate control theory has led to the development of TENS     devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent fibers     increases the control exerted on spinal level, thereby inhibiting the action of afferent     fibers of small caliber related to nociception. This stimulation strengthens the blocking of     gate at the corresponding cell bodies of spinothalamic tract and reduces the transmission     of nociceptive impulses to the spinal cord dorsal horn. This is segmental presynaptic     inhibition depends on the area and stimulated.      The objective of this study is to improve the quality of life through improved sensitivity     disorders of the hand in patients with MS, thanks to reeducation of the hand.   "
108421|NCT01866865|"     Background:      - Women who have a BRCA1/2 gene mutation have a very high risk of developing breast or     ovarian cancer. They are also at increased risk of other developing other cancers. Male     carriers are at increased risk for breast, prostate and other cancers. Testing for this     mutation and living with this increased risk can be a source of stress for both people with     the mutation and their partners. Researchers want to look at how well people adapt to living     with this type of cancer risk over time.      Objectives:      - To see how women with the BRCA1/2 gene mutation and their partners adapt to the stress of     long-term cancer risk.      Eligibility:      - Women at least 18 years of age who have a BRCA1/2 mutation, and their male or female     partners.      Design:        -  This study involves a one-time self-administered questionnaire. Participants will be          recruited from local and national hereditary cancer support groups and cancer centers.        -  There are two versions of the survey. One is for the woman with the BRCA1/2 gene          mutation. The other is for her partner.        -  The survey will ask about risk perception, cancer worry, risk-related stress, and coping          and adaptation methods.        -  Treatment will not be provided as part of this study.   "
108422|NCT01866852|"     Background:      - An earlier study on child development focused on the relationship between children and     their caregivers (usually mothers). It looked at how this relationship influenced children's     social and mental development. It also studied how these children related with family members     and friends. Researchers are now interested in expanding the study with the same group of     children. They want to look at these children, who are now young adults, and focus on their     current romantic relationships. This new study will look at how child development affects the     formation of stable, mature romantic relationships in young adulthood. Original child study     participants and their significant others will be included in the new study. Only     participants who are living together with a partner will be studied.      Objectives:      - To look at romantic partnerships in a childhood study s original participants and their     significant others.      Eligibility:        -  Participants of the 88-CH-32 study who are at least 18 years of age.        -  Significant others of the study participants who are at least 18 years of age.        -  Original participants and significant others must be cohabiting (living together).      Design:        -  No screening tests will be required for this study. No study visits will be needed.          Samples will not be collected.        -  Original study participants will fill out four online questionnaires. They will be on a          National Institute of Child Health and Human Development (NICHHD) website. They will ask          personal questions about relationships with the current romantic partner and other          important people. The questions will take about 25 minutes to answer.        -  Significant others will fill out 13 online questionnaires. They will be on a NICHHD          website. They will ask personal questions about the romantic partner and other important          people. The questions will take about 1.5 hours to answer.        -  All participants will receive a small amount of money for completing the study.   "
108423|NCT01866839|"     Background:      - Researchers are working to make stem cell transplant procedures safer and more effective.     One complication of transplants is graft-versus-host disease (GVHD). This complication     happens when certain white blood cells from the donor attack the recipient's own body.     Researchers want to test a blood separator machine that may help remove more of the donor's     white blood cells before transplant. They will study donors and recipients during stem cell     transplant to see how well this process can prevent GVHD and other complications.      Objectives:      - To see if a new blood separator machine can improve outcomes of stem cell transplants.      Eligibility:        -  Individuals between 10 and 75 years of age who are having a stem cell transplant for          leukemia or other blood-related cancers.        -  Donors for the stem cell transplant.      Design:        -  Recipients and donors will be screened with a physical exam and medical history.        -  Donors will have two blood collection procedures. The first will collect only white          blood cells, and return the rest of the blood. After the first collection, participants          will have filgrastim injections to help their stem cells enter their blood. Then, they          will have a second blood collection for the stem cells.        -  Recipients will have radiation and chemotherapy to prepare for the stem cell transplant.          They will then have the stem cell transplant with the donor cells that have been treated          with the blood separator machine.        -  Recipients will be monitored closely after the procedure. They may receive some of their          donor's white blood cells if needed to fight serious infections.        -  Recipients will have the regular standard of care after their transplant. Blood samples          will be taken and any side effects will be monitored and treated.   "
108443|NCT01866579|"     Ethambutol is widely used as first-line drug, but has serious side effect of optic     neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1~2%,     there was considerable screening efforts and medical cost is increasing. However, there is no     effective treatment of ethambutol optic neuropathy or no definite preventable measure.     Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is     emerging, more toxic secondary drug is used in the long-term.      It is known that retinal nerve fiber layer is increased early stage in ethambutol optic     neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by     optical coherence tomography in longitudinal manner.   "
108444|NCT01866566|"     Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune     procedure we could supply scientific and practical evidence for this two doses immune     procedure promotion and management.   "
108446|NCT01866540|"     This research during the last decade has focused on the kinetics of the systemic and local     immune response to parenteral influenza vaccine in humans. The investigators have shown that     normally high numbers of influenza specific antibody secreting cells (ASC) are present in the     nasal mucosa of healthy adults but upon parenteral vaccination the numbers remain stable.     However, a rapid transient increase in specific ASC is observed in the tonsils and peripheral     blood after parenteral vaccination. In the tonsils, this is associated with a significant     decrease in both naïve/effector (CD45RA+) and memory (CD45RO+) CD4+ cells upon vaccination.     In this study the investigators will extend our work to investigate the characteristics of     influenza-specific T- and B-cells induced locally and systemically after intranasal     vaccination in man.   "
109322|NCT01855061|"     The purpose of this study is to determine whether it is possible to predict response to     chemotherapy in patients with metastatic cancer who are treated with irinotecan by     determining the mutational profile of the tumor.   "
108424|NCT01866826|"     Background:        -  Human immunodeficiency virus (HIV) treatment can control the amount of virus in the          blood, but it does not provide a cure. The reasons why HIV treatment does not cure the          infection are not well understood. HIV persists in blood cells for years, even if people          receive treatment for it. In addition, HIV infection leads to an activated immune          system, which can cause other problems.        -  One theory for why HIV infection causes immune activation involves the intestinal tract.          HIV infects immune cells the intestine soon after infection and damages their immune          barrier. This damage lets bacteria cross into the bloodstream, leading to ongoing          inflammation. Even when a person with HIV feels well, this chronic inflammation may          affect the immune system. Researchers want to see if the antibiotic Rifaximin can reduce          this inflammation. Rifaximin is designed to stay inside the digestive system, so it          affects only bacteria in the intestines.      Objectives:      - To see if Rifaximin can reduce bacteria-related inflammation in people with HIV.      Eligibility:      - Individuals at least 18 years of age who have HIV infection and are taking medications to     treat it.      Design:        -  Participants will be screened with a physical exam, blood test, and medical history.        -  Participants will take either Rifaximin or a placebo for 4 weeks. They will have no          medication for 4 to 6 weeks, and then take the other drug for 4 more weeks.        -  During the study, participants will have frequent blood and urine tests. They will also          provide stool samples. Liver and kidney function tests will be performed. HIV viral load          (the amount of virus in the blood) will also be studied.        -  Participants will have a final follow-up visit after an additional 4 weeks.        -  Two additional tests are optional for study participants:        -  Two blood draws: one on the third day after starting Rifaximin, and one on the third day          after starting the placebo.        -  Up to three colonoscopies of the lower intestine and biopsies of the intestine. These          studies will collect samples of the intestinal tract to look at the effects of Rifaximin          in the study.   "
108425|NCT01866813|"     The aim of the proposed study is to investigate whether women treated for breast cancer who     experience cognitive difficulties will profit from the Internet-based program Scientific     Brain Training Pro with respect to: 1) attention, working memory, learning and recall, and     executive function as assessed by standardized neuropsychological tests and 2,) self-reported     cognitive difficulties in daily life as measured by questionnaires.   "
108426|NCT01866800|"     Evaluating whether forced diuresis with matched hydration will reduce the risk of contrast     induced nephropathy in patients undergoing Transcatheter Aortic Valve Implantation (TAVI).   "
108427|NCT01866787|"     The purpose of this observational study is to evaluate the baroreceptor function in relation     to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.      The main hypothesis is that baroreceptor function is attenuated after surgery and related to     surgical inflammation.   "
108428|NCT01866774|"     Triaging new pediatric gastroenterology consultations is challenging as both inflammatory and     non-inflammatory gastrointestinal (GI) diseases can present with non-specific chronic     abdominal pain and/or diarrhea. Examples of inflammatory GI diseases include Crohn's disease,     ulcerative colitis and celiac disease and non-inflammatory GI diseases lactose intolerance,     irritable bowel syndrome and non-ulcer dyspepsia. Inflammatory GI diseases require different     investigations and treatment than non-inflammatory GI diseases and ideally, would be     identified early. Higher priority triage of these patients would allow timely organization of     further investigations including pertinent laboratory testing, radiologic studies and     gastrointestinal endoscopies. These more invasive procedures are not needed in most patients     presenting with non-specific gastrointestinal symptoms. Therefore, the investigators do not     routinely ask for screening laboratory testing or other studies in children referred to our     clinic.      Non-invasive screening tests for GI disorders may aid in appropriately triaging new     consultations to pediatric gastroenterology. Calprotectin is a protein found in inflammatory     cells called neutrophils. The concentration of calprotectin in stool reflects the presence of     an inflammatory process occurring in the GI tract. Thus, testing for calprotectin has been     proposed as a potentially useful test for detecting some inflammatory GI diseases, most     notably Crohn's disease and ulcerative colitis. Alternatively, a simple gastrointestinal     questionnaire of red flag symptoms and family history of GI disorders may also be of     benefit. The investigators hypothesize that the use of fecal calprotectin and a screening GI     questionnaire will aid in identifying children at higher risk of an inflammatory GI disorder.     Subsequently, higher priority triaging of these patients will decrease the time to diagnosis     of inflammatory GI disease.      This will be a single centre, stratified, randomized clinical trial conducted in Kingston,     Ontario, Canada. Patients referred to the pediatric gastroenterology service without a known     diagnosis for non-specific chronic abdominal pain and/or diarrhea will be asked to     participate in the study. All patients who meet the inclusion criteria will be consented by     telephone with a standard form. Consenting patients will be mailed the GI questionnaire and     the fecal calprotectin test kit. The fecal calprotectin test kid includes instructions, a     stool collection kit and return postage. All patients will be given the next available     appointment with a pediatric gastroenterologist. Patients will then be randomized to receive     either usual care (50%, 40 patients) or to have a screening fecal calprotectin (FC)     measurement (50%, 40 patients). Patients in the FC group will have FC measured by the Quantum     Blue® Rapid Calprotectin Assay. If the calprotectin level is high (above 50 μg/g), the     patient will be contacted again by telephone and given a new appointment time (within 14     working days). This study may have a positive impact by demonstrating a novel method for     decreasing the time to diagnosis of inflammatory GI disease.   "
108429|NCT01866761|"     Objective: We aimed at analyzing the relationship between periodontal disease and     atherosclerosis in medical treatment and periodontal treatment under medical and dental care     across borders in a local cooperation system of Japanese medical services.      Materials and methods:        -  A prospective multi-center case cohort study was conducted on 37 ambulatory medical          patients (with lifestyle-related diseases under consultation in either of the medical          clinics registered as collaborative investigation facilities) and 79 periodontal          patients (who were seen by the dental clinics registered as collaborative investigation          facilities).        -  Medical treatment and clinical periodontal treatment were provided on the subjects under          medical and dental care across borders by each internal medicine and dental clinics.        -  Systemic examination of lifestyle-related disease and periodontal examination were          performed before and after periodontal treatment, and the relationships between          periodontal and atherosclerosis-related clinical markers were analyzed before and after          periodontal treatment.   "
108430|NCT01866748|"     This trial is conducted in Europe. The aim of the trial is to investigate the safety,     tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single     and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in     healthy male subjects.   "
108431|NCT01866735|"     This study will demonstrate that Standardized Rehabilitation Therapy for burn patients with     ARF reduces hospital stay through immediate improvement in functional capacity and functional     performance. Our team comprises Burn Surgeons, Intensivists with expertise in Critical Care     Trial design, Exercise Physiologists and Outpatient Functional Outcome Assessment Experts.     The design was conceived through the US-Critical Illness and Injury Trials Group which     allowed these investigators to bring varied expertise to the problems faced by critically ill     Burn patients.      Hypotheses:1) Standardized Rehabilitation Therapy (SRT) will shorten hospital stay in burn     patients with ARF. 2) SRT will prevent loss in muscle size and loss of architecture during     critical illness of severe burns. 3) SRT will improve objective functional measures and     quality of life at 3, 6, 12, 24, and 36 months post-enrollment.   "
108445|NCT01866553|"     The purpose of this trial is to assess the effect of switching CML patients, who have been     treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease     between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the     proportion of patients who achieve confirmed MR4.0.   "
108624|NCT01864213|"     Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It     is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain     of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not been     studied.   "
108432|NCT01866722|"     In our communications with the public, the investigators will call this the Not Quite Ready     to Quit Smoking Study.      One new method to increase quit attempts is to have smokers reduce their cigs/day. The     investigators and others have shown that reduction aided by nicotine medications can increase     quit attempts and later abstinence among smokers not ready to quit. Because half of smokers     are reluctant to use nicotine medications for a non-cessation reason, the investigators now     propose to test whether reduction not aided by nicotine medications can be effective. Another     new method to increase quit attempts is motivational counseling. The investigators previously     found implementation of the brief United States Public Health Service (USPHS) Guidelines 5 Rs     motivational intervention via three 15 min phone calls can provide a large increase in     quitting (OR = 6.3); however, the investigators need to replicate that result. A vendor will     proactively email adult, daily smokers listed in a consumer panel to recruit 560 smokers who     do not plan to quit in the next month and randomize them to a) reduction counseling without     the aid of nicotine medications , b) brief counseling guided by the USPHS 5 R's, or c) usual     care. The first two conditions will be delivered via brief counseling calls at study onset     and then 2 and 4 weeks later (total = 35 min). The usual care condition will consist of a     brief (< 5 min) phone intervention followed by a quit guide. Our major hypothesis is that the     incidence of quit attempts over the 6 months of the study will be greater in both the     reduction and the motivational conditions than in the usual care condition. A secondary     hypothesis is that the increase in quit attempts will lead to increased abstinence. Another     secondary hypothesis is that beneficial effects of both treatments will be mediated by     increases in self-efficacy and intentions to quit. A final hypothesis is that decreases in     cigs/day and nicotine dependence will mediate the efficacy of the reduction treatment but not     the motivational treatment and, conversely, that a shift in decisional balance will mediate     the efficacy of the motivational treatment but not of the reduction treatment.   "
108433|NCT01866709|"     It is hypothesized that SPS is more effective than placebo control (alternative hypothesis)     in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 -     6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).   "
108434|NCT01866696|"     Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23     edentulous jaws treated with 3D software planning, guided surgery, immediate loading and     restored with Cad-Cam Zirconia and titanium full arch frameworks.      Material & methods: This study was designed as a prospective clinical trial. Twenty patients     have been consecutively rehabilitated with an immediately loaded implant supported fixed full     prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were     placed , 22 of which in fresh post extraction sockets. All the implants were inserted with an     insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other 3     were delayed loaded.      Outcome measures were implants survival, radiographic marginal bone-levels and bone     remodeling, soft tissue parameters and complications.   "
108435|NCT01866683|"     Since yoga breathing exercises are traditionally used to tranquilize the mind, and have a     well-known positive effect on the cardiovascular system, it is our hypothesis that a     respiratory yoga exercise named bhastrika pranayama may have positive effects on heart rate     variability, electroencephalography, quality of life and salivary cortisol (stress hormone).   "
108436|NCT01866670|"     Condition: patients with breast cancer. Intervention: spiritual support (relaxation + image     guided + meditation) or relaxation in three consecutive meetings (day 2, 3 and 4), three days     of intervention in the same week. The first day the participants will be evaluated if she     meets the needs of the research and will answer questions about their indentification and     spirituality.      Type of study: intervention Study design: randomized controlled trial Masking: blind study.     Randomization: sequence generated by SPSS (Statistical Package for the Social Sciences)     version 15, organized in sealed envelopes by another qualified professional.      The research ends in 2014 jun.   "
108437|NCT01866657|"     This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly     patients undergoing thoracic surgical procedures that require the use of single lung     ventilation. The hypothesis is that subjects randomized to open cerebral oximetry monitoring     that have active intervention to mitigate observed desaturations will have measurable     postoperative clinical outcome benefits when compared to the patients randomized to blinded     cerebral oximetry monitoring with no active interventions to mitigate desaturations.   "
108438|NCT01866644|"     Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC),     decreasing the incidence of primary graft dysfunction and primary failure. The degree of     dysfunction will be monitored by the method of LIMON, metabonomics techniques and according     to the latest published validation Liver Transplantation (16 943-949 2010), total     billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day     and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days.     Liver dysfunction is considered, the presence of a transaminase value> 2000 IU / L 1-7     postoperative day or BT> 10 mg / dl or INR> 1.6, both only in the 7th postoperative day     (Olthoff et al Liver Transplantation 16,943 -949 2010).   "
108439|NCT01866631|"     The investigators hypothesise that the research data will enable them to elucidate local     clinical practices with regard to breast cancer care and enable them to extrpolate the data     to improved local clinical care for their patients through self-regulation and audit.   "
108440|NCT01866618|"     Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron & hCG.     Patients will not be given any other stimulating medications during the cycle. They will have     2 uterine aspirations and an endometrial biopsy at designated times. The first uterine     aspiration will be randomized to one of four days (day before retrieval, day of retrieval,     day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial     biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for     Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.   "
108441|NCT01866605|"     Patients are often anxious immediately before surgery. The investigators hypothesis is that a     warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.   "
108442|NCT01866592|"     VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects     of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained     improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E     extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood     and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections     following FDA-approved psoriasis treatment regimen.   "
108467|NCT01866267|"     This pilot single arm, single site, open-labeled switch study seeks to enroll thirty (30) HIV     positive patients infected with CCR5 tropic virus that have achieved an undetectable viral     load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse     Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase     Inhibitor (NRTI)] and switch them to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs.   "
108468|NCT01866254|"     The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as     well as intrathecal morphine after cesarean delivery, with fewer side effects.   "
108447|NCT01866527|"     Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the     choice of screening strategy is debated. The investigators evaluated the effect of a     selective ultrasound (US) screening programme.      All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e.     clinical hip instability, breech presentation, congenital foot deformities or a family     history of DDH, were subjected to US screening at age one to three days. Severe sonographic     dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild     dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were     followed clinically and sonographically until spontaneous resolution, or until treatment     became necessary. The minimum observation period was 5,5 years.   "
108448|NCT01866514|"     This will be a prospective, non-controlled study using healthy adult volunteers as subjects     receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the     insertion technique and IO infusion flow rates.   "
108449|NCT01866501|"     A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus     Intraosseous Vascular Access Insertion Site   "
108450|NCT01866488|"     The current study is a randomized, controlled, double-blinded trial of Obstetric Cook     Catheter combined with oral misoprostol for induction of labor in pregnant patients. The     primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in     combination with oral placebo and the Obstetric Cook Catheter in combination with oral     misoprostol. Secondary outcomes to be studied include the safety of the method, composite     maternal morbidity and composite neonatal morbidity.      The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive     both the Obstetric Cook Catheter and the oral misoprostol.   "
108451|NCT01866475|"     A prospective study to determine the safety of intraosseous (IO) access for a period up to 48     hours in healthy adult volunteers and volunteers with a history of mild to moderate renal     disease and/or controlled diabetes.   "
108452|NCT01866462|"     The purpose of the study is to determine if NM504 will prevent GI side effects that are     associated with using metformin for the treatment of diabetes.   "
108453|NCT01866449|"     The proposed study is an open-label, single-arm, Phase- II trial to assess the efficacy of     cabazitaxel in GBM WHO grade IV patients with a progression during or within 6 months after     last temozolomide treatment (Figure 1).      Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks with standard     concomitant medication (as outlined below):        -  On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25mg/m²,          administered by i.v. route in 1 hour.        -  Cycle length for cabazitaxel is 3 weeks (21 days).        -  New cycles of therapy may not begin until Absolute Neutrophil Count (ANC) ≥1500/mm3,          platelet count ≥75 000/mm3, and non-hematological toxicities (except alopecia) have          recovered to baseline.        -  A maximum of 2 weeks (14 days) delay is allowed between 2 treatment cycles.        -  Patients should come off treatment if treatment delay is more than 2 weeks.      At least 30 minutes prior to each administration of cabazitaxel, patients will receive i.v.     premedication including:        -  An antihistamine (dexchlorpheniramine 5mg, diphenhydramine 25mg, or equivalent). In case          of i.v. antihistamine other than promethazine is not being available, local practice          should be followed.        -  Corticosteroid (dexamethasone 8mg or equivalent)        -  H2 antagonist (ranitidine or equivalent).        -  Antiemetic prophylaxis is recommended and can be given orally or intravenously if          necessary.        -  Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) should be given          on day 4 of each treatment cycle as per ASCO and ESMO guidelines.   "
108454|NCT01866436|"     To practice independently surgeons require competency in surgical skills, encompassing a     combination of technical and non-technical skills. Cognitive skills, aspects of non-technical     skills, represent an integral component of surgical competency. Cognitive skills comprise     factual knowledge and decision-making.      Changing work patterns in the United Kingdom, as specified by the European Working Time     Directive (EWTD), have had a profound impact on the delivery of surgical skills training.     Surgical trainees are now increasingly removed from normal working hours in which the     majority of traditional operative training and experience is gained, leading to a net     reduction in trainees' operative exposure. This reduction in operative experience means that     surgical competence can no longer be assured on the basis of experience alone.      Although there is no educational technology that can replace the craft apprenticeship     required to train a competent surgeon, reduction in training hours has led to rapid     development of educational tools to augment surgical skills training outside the operating     room environment. These tools tend to concentrate on technical skills performance without     emphasis on cognitive skills.      Trainees in today's era have grown up in a multimedia environment; multimedia is media that     uses a combination of text, voiceover, animation and video. Multimedia is an underdeveloped     educational resource that can supplement cognitive skills training in operative surgery.      The purpose of this study was to design and develop an online multimedia educational tool in     a common colorectal surgery procedure (Anterior Resection) and determine the effectiveness     of this tool in teaching and assessment of cognitive skills.      Study hypothesis: Multimedia learning is equivalent to conventional teaching Study Day in     improving scores in cognitive surgical skills.   "
108455|NCT01866423|"     This phase II trial studies how well orteronel works in treating patients with metastatic     hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
108456|NCT01866410|"     This phase II trial studies how well cabozantinib-s-malate and erlotinib hydrochloride works     in treating patients with previously treated metastatic non-small cell lung cancer.     Cabozantinib-s-malate and erlotinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the     growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving     cabozantinib-s-malate together with erlotinib hydrochloride may be an effective treatment for     non-small cell lung cancer.   "
108469|NCT01866241|"     Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of     third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to     10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of     third stage of labor   "
108489|NCT01865981|"     Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life     threatening conditions affecting otherwise healthy young individuals. Due to the     inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells     causing the rhythm disturbance can be difficult to study in detail and therefore in many     cases remain untreatable. The investigators propose to study heart cell electrical function     from such patients by reprogramming skin cells to become stem cells and then differentiating     them to heart muscle cells.      The hypothesis of the study is that the differentiated cardiac cells will display electrical     abnormalities dependent on the mutation causing the disease. These abnormalities can     therefore provide a clue as to the nature of the mutation causing the disease or information     about its effective management   "
108457|NCT01866397|"     Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against     herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro     studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis     in patients with AIDS and as a second line therapy for HCMV infections not responding to     ganciclovir or foscarnet.      In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established     extracorporal renal replacement therapy with a high clearance rate.      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are     rare. Elimination of any given drug by renal replacement therapy is determined by several     major factors which are membrane specific, due to physico-chemical properties of the drug and     characteristics of the renal replacement technique used.      Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir     during CVVH in critically ill patients. It is suspected that Hemofiltration will influence     cidofovir plasma levels.   "
108458|NCT01866384|"     Early hematoma growth (HG) after spontaneous intra-cerebral/intra-parenchymal hemorrhage     (IPH) is common and associated with neurological deterioration and poor clinical outcome.     Temperature modulation to hypothermia (Temperature, 32-34°C) has been associated with     reduction or improvement of physiopathologic processes associated with inflammatory     activation and degradation of blood-brain barrier after all types of brain injury. In this     sense, we believe that the initiation of an ultra-early protocol of active temperature     modulation or Targeted Temperature Management (TTM) to mild induced hypothermia (MIH,     32-34°C) may be associated with good safety and tolerability profile, less HG and cerebral     edema after IPH by modulation of systemic and local inflammatory responses, so we hypothesize     that TTM to MIH will be a safe/tolerable and effective therapy to limit HG and cerebral edema     after IPH.   "
108459|NCT01866371|"     Studying the morphology and function of the normal and diseased retina in vivo is needed for     advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an     adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina     with individual cellular resolution non-invasively. The primary objective of this study is to     obtain and analyze high-resolution images of the retina, in particular by imaging the cone     photoreceptor mosaic, the retinal vasculature and other retinal layers. The study design will     involve case-control studies, where cases are followed over time. Subjects age 7 and older     may be invited to participate. The main research procedure involves retinal imaging with the     AOSLO. The primary endpoint is the observation of differences in retinal images between     subjects with and without retinal diseases. These changes will be quantified by examining the     cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as     examining the differences between other retinal layers.   "
108460|NCT01866358|"     Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated     resuscitation   "
108461|NCT01866345|"     The purpose of this investigation is intended to evaluate the efficacy of surgically     facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root     shortening, and occurrence of mucogingival side effects compared to conventional orthodontic     therapy in patients undergoing orthodontic treatment to correct crowding and/or     retroclination of their mandibular anterior dentition.   "
108462|NCT01866332|"     The purpose of this study is to determine the effectiveness of the addition of the use of     Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional     physical therapy.   "
108463|NCT01866319|"     This study will evaluate the safety and efficacy of 2 different dosing schedules of     pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2     schedules to treatment with ipilimumab in ipilimumab-naïve participants with unresectable or     metastatic melanoma.      Participants assigned to treatment with pembrolizumab could receive up to 2 years of     treatment; if participants stopped treatment at 2 years and later experienced progression,     they were eligible for a second course of treatment for up to 1 additional year. With     Amendment 05, all Second Course participants will be treated with a fixed dose of     pembrolizumab 200 mg Q3W.   "
108464|NCT01866306|"     The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers     for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB)     in healthy and asthmatic participants, and to identify an appropriate dosage of RV16UB in     order to study biomarkers in asthmatic participants. The study is divided into 2 parts. Part     1 is a dose-finding study where healthy participants, and asthmatic participants, who were     either treated or not treated with a class of long-acting beta antagonists (LABA) will be     recruited to undergo nasal challenge with increasing doses of RV16UB. Part 2 is a biomarker     study where mild to moderate asthmatics undergo challenge with the most appropriate dose of     RV16UB identified in Part 1, based on tolerability and viral effects. .   "
108465|NCT01866293|"     This study is an open label phase I/II trial to investigate the safety and efficacy of     Cabozantinib for patients with relapsed or refractory myeloma.   "
108466|NCT01866280|"     The purpose of this study is to test the effects of sleep and meal timing, independent of     sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in     normal weight adults.      This study will be a 4-phase, randomized controlled study of 5 days each in which     participants will undergo 2 phases of late sleep times that differ in meal timing (normal or     late) and 2 phases of normal sleep times that differ in meal timing (normal or late).      The Aims and Hypotheses of this study are:      Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response     to altered sleep and meal timing.        -  Hypothesis 1: There will be an interaction between sleep and meal time on glucose,          insulin, and glucose and insulin area under the curve after the glucose tolerance test          such that the late sleep/late meal will result in the worst metabolic profile, normal          sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal          sleep/normal meal will result in the best metabolic profile.        -  Hypothesis 2: There will be an interaction between sleep and meal time on leptin and          ghrelin concentrations such that the late sleep/late meal timing phase will result in          low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will          have an intermediate profile, and normal sleep/normal meal timing will result in high          leptin/low ghrelin.      Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal     timing.      • Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase     compared to normal sleep timing.   "
108470|NCT01866228|"     The time period from diagnosis through to the end of treatment is challenging for patients.     Patients need information, assistance with decision making, and emotional and social support     to help cope with their diagnosis and treatment. The first meeting with the cancer doctor is     especially anxiety-provoking for patients who will learn, for the first time, their treatment     options and likelihood of being cured. This anxiety causes many patients to have difficulty     remembering the important pieces of information that their cancer doctor tells them during     this consultation. The main goal of this study is to demonstrate the benefits of giving     cancer patients an audio-recording of their first consultation with their cancer doctor. The     investigators will include newly diagnosed patients from cancer centres in Winnipeg and     Calgary. The types of cancer that will be included in this study are brain and     neuroendocrine. Patients with these types of cancer are more likely to have confused     thinking, and therefore may have the most to gain from receiving their consultation     recordings. The study will include 244 patients, and those who sign consent forms to     participate will be assigned by chance to either receive their treatment consultation     recording or not. Patients will receive their recording immediately after their consultation,     and will be able to listen to the recording at any time either alone, or with family and     friends. To figure out whether the consultation recording provides patients with benefits,     the investigators will administer some questionnaires to patients at 1 week after the     consultation, and again at 3 and 6 months after the consultation. These questionnaires will     assess the following patient outcomes: i) anxiety and depression, ii) perception of being     informed about the disease and treatment, iii) satisfaction with cancer care, iv)     satisfaction with the doctor, and v) the extent to which patients are satisfied with their     degree of involvement in treatment decision making. The investigators hypothesize that     patients who receive their consultation recording will experience more benefits than patients     who do not receive their consultation recording.   "
108471|NCT01866215|"     A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in     sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic     de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced     dyslipidemia.This study will evaluate        1. how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed          before fructose ingestion 1b) when exercise is performed after fructose ingestion          Metabolic effects of exercise will be assessed in healthy male subjects by measuring          fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose          concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very          low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled          fructose meals        2. how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion          after exercise Healthy male subjects will be fed various fructose, glucose, lipid and          whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The          effects of meals' composition will be assessed after 24 hours by measuring          intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).   "
108472|NCT01866202|"     Aims: To evaluate the role of monoclonal antibodies in the detection of cancer specific     antigens in blood and tumor tissue, and the potential use of these antibodies for future     evaluation for therapy. Also, to evaluate the presence of circulating tumor cells (CTCs) and     to study EMT (epithelial-mesenchymal) signature changes during chemotherapy.      Methods: To take 20mls of blood from advanced breast cancer patients before a new course of     anti-cancer therapy, and another 20mls of blood 3 weeks after treatment. In addition, Consent     will be obtained to cut 10-15 tissue sections from their archival tumor specimens. Whenever     possible, the blood taking will be timed such that no additional needle prick will be done     specifically for the purpose of the study, by coinciding it with standard blood taking which     is required for the patient's treatment.      Importance of proposed research to science or medicine:Detection of tumor specific antigens     in the blood may potentially reduce the need for more invasive biopsies for confirmation of     diagnosis of cancer or follow-up of cancer in the future. The identification and development     of antibodies specific to these tumor antigens or markers may offer future therapeutic     options, or as a vehicle to deliver cytotoxic therapy. Identification of CTCs as well as     understanding the changes that occur in EMT signature in these circulating tumor cells may     serve as a means of potential means of prognostication and modification of therapy in the     future.      Potential Benefits and Risks: Potential risks to the patient include that of blood taking     (pain, feeling faint, infection). Patients will not benefit directly from the study but the     knowledge gained may help the management of future patients.      Cancer biomarkers, such as antigens and circulating tumor cells, may be a potential area to     developing new methods of diagnosis and treatment of cancer. Monoclonal antibiotics are now     able to be identified and isolated that may specifically target progenitors of breast cancer     as well as CTCs. The changes that occur to CTCs during treatment may serve as a means of     prognostication, as well as allow for therapeutic modifications. Clinical correlative studies     into these areas (MAbs and CTCs) will serve to determine the role of these in clinical     application in the future.   "
108473|NCT01866189|"     This study is a French multicenter prospective study including 5 stroke units with available     MRI and F-MISO PET for patients with acute ischemic stroke.      Background and Purpose: 18F-Fluoromisonidazole (FMISO) PET has been used to identify hypoxic     tissues in animals and stroke patients. While MRI has become the gold standard acute stroke     imaging, no published study has compared FMISO PET and MRI.      The aim of this prospective study is to identify hypoxic tissues in 40 patients with acute     ischemic stroke with F-MISO PET and to compare the location and the outcome of these hypoxic     cells with MRI datas (weighted diffusion and FLAIR) and to clinical outcome.   "
108474|NCT01866176|"     The purpose of this study is to evaluate the immediate effects of a knee brace with a new     mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis     patients. The effects of this new brace is compared to a stabilizing brace and a typical     valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear     each of the three braces during three months. A fifteen days wash-out period is given after     each three months. Biomechanical evaluation is carried out before and after each three     months. This evaluation consisted of three questionnaires (KOOS, WOMAC and Medical Outcome     Score Short Form-36 (MOS-SF36)), a motion analysis with an optoelectronic system, then a     6-min walk test. During motion analysis, ten gait trials are executed without brace and ten     with the brace.   "
108475|NCT01866163|"     The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of     treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.   "
108476|NCT01866150|"     This cross-sectional, non-interventional, retrospective chart review will compare the     efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy     in patients with rheumatoid arthritis who have had an inadequate response to prior treatment     with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected     from patients who have been on first-line biologic treatment for at least 6 months.   "
108477|NCT01866137|"     The aim of the PsyCo Study is to determine whether psychological Stress has an influence on     copeptin levels.   "
108487|NCT01866007|"     The purpose of this study is to evaluate the pharmacokinetic (what the body does to the     medication) comparability of guselkumab in lyophilized and liquid formulations. Also to     evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as     prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe     facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration     of 100 mg guselkumab in healthy participants.   "
108488|NCT01865994|"     The purpose of this study is to determine the measuring accuracy of the truly non-invasive     method estimated continuous cardiac output (esCCO) against the reference method     transesophageal echocardiography in pediatric cardiac surgery. esCCO is calculated using the     pulse wave transit time, which is defined as the time between the R-wave of the ECG and the     30% increase of the differentiated pulseoximetry waveform.   "
108478|NCT01866124|"     The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer     program in the framework of a safety net to prevent acute malnutrition by children under 24     months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region     of Burkina Faso, Africa). The program will be targeted to economically vulnerable households     with children less than 1 year old at the time of inclusion and the cash distributed to     mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries'     self-determination on the use that will be made of cash. This study will be designed as a     two-arm cluster randomized intervention trial, based on randomization of rural villages of     the Tapoa province. One arm will receive the intervention and one will be a control arm. The     main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the     cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as     well as indicators of dietary diversity, food security, health center frequentation,     families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be     analyzed. Finally, based on a model theory framework built a priori, the pathways used by the     cash to have an effect on the prevention of under-nutrition will be assessed.   "
108479|NCT01866111|"     This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with     an 8-week prospective baseline and an 18 week double-blind treatment period (including a     6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study     drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for     subjects who will participate in the open-label extension).      The primary objective of this study is to determine the effective dose range of YKP3089 as     adjunctive therapy for the treatment of partial seizures.      The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy     population.   "
108480|NCT01866098|"     This study is designed to look at the effects of naltrexone on weight loss in individuals     treated with antipsychotic medications. Naltrexone is an FDA approved medication for the     management of alcohol dependence and drug dependence, but has not been fully evaluated for     its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia,     schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out how     effective two different doses of oral naltrexone is on reducing body weight when compared to     placebo (an inactive substance or sugar pill).   "
108481|NCT01866085|"     The study is designed to assess efficacy and subject satisfaction of two sling devices:     Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.   "
108482|NCT01866072|"     Transient elastography is novel non-invasive method for assessment of hepatic fibrosis in     patients with chronic liver disease, by measuring liver stiffness. Transient elastography is     a user friendly technique that can be easily performed at bedside or in outpatient clinic     with immediate results and good reproducibility.      Liver stiffness values ranges from 2.5 to 75 kPa with lower values <6kPa suggest no fibrosis     where as higher values above 14kPa suggests cirrhosis. In the present study the investigators     hypothesis that the investigators can differentiate ACLF and acute severe viral hepatitis     based on fibroscan as patients with underlying fibrosis with superadded inflammation would     have higher fibroscan value than when patient have only inflammation with no underlying     fibrosis and hence the investigators can avoid unnecessary test in such subgroup.   "
108483|NCT01866059|"     This study will involve filling teeth which have decay on their roots with three different     filling materials. Patients will attend Cork University Dental School and hospital for a     clinical examination and to complete a questionnaire describing how they feel about the     comfort and appearance of their teeth. Patients will be asked to provide a sample of saliva     by spitting into a tube. This saliva will be tested to see what levels of bacteria are     present and how well their saliva neutralises acid in their diet. This is used to assess how     high or low the patient's risk of dental decay is. They will also complete a questionnaire     about the amount of sugar in their diet and how often they clean their teeth. If the exam     shows that any teeth are so decayed that they cannot be filled, the patient will then be     offered extraction of these teeth. All treatment will be discussed with the patient. Patients     will be randomly assigned one of the three materials and this material will be used for their     fillings. Patients will not know which of the three materials they received but all three     materials are already in use in dentistry and all of the elements of each treatment plan are     well recognised, routine dental procedures. After all the treatment has been completed, each     patient will be shown how best to take care of their teeth and how to manage their sugar     intake to reduce their risk of further decay.      Patients will be given appointments to return for review at 6 months, 12 months, 18 months     and 24 months after treatment. This will include a dental examination and dental impressions     will be taken. These are used to measure how the restorative materials wear over time.     Patients will also be asked to complete again the two questionnaires that they completed at     their first visit to see if any of their answers have changed.   "
108484|NCT01866046|"     This is a developmental study evaluating a new rapid HIV testing and risk prevention     intervention for residents of battered women's shelters who endorse risky sexual behaviors.   "
108485|NCT01866033|"     The purpose of this study is to assess the absolute bioavailability of oral PCI-32765 and the     effect of grapefruit juice on the absorption of PCI-32765 in healthy adult participants.   "
108486|NCT01866020|"     Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high     morbidity and mortality in critically ill patients in the ICU. Accepted diagnostic protocols     for haemato-oncological patients are not applicable for critically ill patients in ICUs.     Definitive discrimination between aspergillic colonisation and IPA often depends on the     clinical experience of the treating physician, evaluating clinical signs, co-morbidities, and     course of the disease. Life saving treatment with the first line antimycotic Voriconazol     (Vfend®) can only be initiated after diagnosis of IPA.      In this prospective clinical trial the investigators aim to structure, optimize and fast     track the diagnostic pathway of IPA in critically ill patients treated in our ICU-department.   "
108542|NCT01865292|"     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics     (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the     trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not     similar to the proposed commercial formulation, with insulin glargine in subjects with type 1     and type 2 diabetes.   "
108491|NCT01865955|"     Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly     performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to     facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar     punctures, performance of spinal anesthesia in non-obstetric patients and accurate     identification of the interspace at which the puncture is being performed. This is especially     important during spinal anesthesia, where puncture below the ending of the spinal cord is     recommended for safety.      The purpose of this study is to compare the performance of spinal anesthesia between the     pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in     term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe     sonoanatomic features of the spine that could predict the ease of insertion of spinal     anesthesia in that patient population.      We hypothesize that in term pregnant women undergoing elective cesarean delivery,     pre-procedural ultrasound assessment of the spine will improve the success rate of spinal     anesthesia at first attempt, compared to the traditional palpatory technique.   "
108492|NCT01865942|"     The investigators wish to evaluate the effect of minimal access spinal surgery compared to     traditional open surgery spinal surgery in patients with metastatic spinal cord compression.      Minimal access surgery has been shown to bee less damaging for the tissue compared to     traditional open surgery and also cause fewer wound complications, the investigators expect     the above could have impact in a vulnerable patient group like patients with metastatic     spinal cord compression.   "
108493|NCT01865929|"     A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods;     robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy;     outcome and cost analyses.   "
108494|NCT01865916|"     This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority     trial. The purpose of our study is to determine if using a 2-litre mixture in combination     with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre     PegLyte based preparations with an added laxative agent are commonly used for colonoscopies     in outpatient settings. If the investigators discover that a 2-litre mixture with either the     tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be able     to experience fewer side effects and be less troubled by the preparation while still allowing     a good view of the colon.   "
108495|NCT01865903|"     Weight loss and loss of lean body mass are common and associated with adverse outcomes such     as loss of strength, reduced immune- and pulmonary function and increased disability in     advanced cancer. Progressive weight loss interferes with cancer therapy and is responsible     for reduced quality of life (QoL) as well as shorter survival irrespective of tumour mass or     presence of metastases. Weight loss in advanced cancer is regarded as a major clinical     challenge because of its serious consequences, its varying aetiology and the contribution of     multiple pathophysiological mechanisms that are poorly disentangled.   "
108496|NCT01865890|"     The investigators are trying to find out if Clopidogrel (Plavix) is as effective in     hemodialysis patients as in patients not hemodialysed.   "
108497|NCT01865877|"     The objective of the study is to assess the effect of motor, non-motor and genetic factors on     the progression of Parkinson's disease as well as its impact on complications rates.      A large sample of Mexican subjects with Parkinson's disease attending several referral     centers will be included.      Data collected will include disease severity and motor scales, non-motor scales as well as     genotyping for monogenic forms of the disease.      Assessments will be performed every 6 months for two years.   "
108498|NCT01865864|"     to test whether using CPAP can restore the normal pattern of drop of blood pressure during     sleep.   "
108499|NCT01865851|"     Currently used face mask has certain disadvantages; such as, not providing a complete seal in     certain patients, causing hand fatigue after holding the mask in place for more than a few     minutes, causing claustrophobia in an occasional patient, the need to hold the mask from head     of the bed, and possible worsening of the trauma in patients with facial injuries, and the     need to use different size masks in different patients. The NuMask overcomes all of these     disadvantages and does benefit the patients.   "
108500|NCT01865838|"     The investigators intend to determine the role of Seprafilm, a popular anti-adhesive agent in     minimising internal adhesion formation in the neck after thyroid surgery and therefore reduce     swallowing discomfort experienced by patients after surgery.   "
108501|NCT01865825|"     The investigators would like to determine if there are patients with PPI responsive     Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility     suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.      If this group of patients exists, the investigators would like to determine if they have the     typical endoscopic features of EoE rather than those of GERD.   "
108502|NCT01865812|"     The purpose of this study is to determine if obeticholic acid (OCA) has an effect on     cholesterol levels in the blood in patients with PBC.   "
108543|NCT01865279|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec     (insulin 454), an explorative formulation, not similar to the proposed commerical     formulation.   "
108503|NCT01865799|"     This is a prospective, 3-year observational study to describe drug utilization in uninfected     individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)     (Truvada®) for a pre-exposure prophylaxis (PrEP) indication.      An electronic source of pharmacy/medical encounter information will be used to assess the     demographics and other characteristics of the subjects prescribed FTC/TDF or its components     in a prospective fashion. The data provider will supply all the de-identified information     regarding each visit/interaction that the subject has had with the health system and all the     diagnoses and medications that the UI has had prospectively and retrospectively for the     length of time captured by the source selected.      200 physicians who prescribe FTC/TDF for a PrEP indication will be sampled from the same     source.   "
108749|NCT01862588|"     Record the renal resistive index and hemodynamic parameters ( record the cardiac output and     stroke volume if the patient's next to kin agree to undertake a PiCCO monitoring ) before and     after resuscitation for severe sepsis or septic shock patients, to determine whether the     changes of resistive index or hemodynamic parameters, especially the cardiac output can be a     better parameter to predict AKI   "
108504|NCT01865786|"     This is a prospective, observational study to describe pregnancy outcomes among HIV-1     uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate     (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the     Antiretroviral Pregnancy Registry (APR).      Information on subjects is provided to the APR prospectively (prior to the outcome of the     pregnancy being known) through their healthcare provider, with follow-up obtained from the     healthcare provider following determination of the pregnancy outcome.   "
108505|NCT01865773|"     A major limitation of standard hemodialysis is that it does not clear the plasma from     interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular     risk in end stage renal disease (ESRD). In the present study, we evaluated whether these     compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the     ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge.     We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240     minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by     comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol     levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start     or at the end of the HFR session. The proinflammatory activity of UFin and UFout was     determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid     (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8     healthy volunteers and cultured in vitro for 24 hr.   "
108506|NCT01865760|"     With increasing rates of obesity the number of anti-obesity operations performed is     increasing; one of the most common is gastric bypass. Anti-obesity surgery ameliorates     diabetes and several other serious comorbidities, but bariatric surgery is also associated     with medical and nutritional complications.      Post-gastric bypass hyperinsulinemic hypoglycemia is a relative rare but serious complication     often seen months to years after gastric bypass surgery. The patients experience     neuroglycopenic symptoms (eg. inability to concentrate, weakness, altered mental status, loss     of consciousness).      The purpose of this study is to determine whether glucagon-like peptide-1 (GLP-1)or other     enteropancreatic factors (eg. gastric emptying rate) are responsible for the excessed insulin     secretion seen in some patients after bariatric surgery.   "
108507|NCT01865747|"     The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with     Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in     subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine     kinase inhibitor therapy.   "
108508|NCT01865734|"     Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical     therapy practice and often is associated with chronic symptoms, and disability. Persistence     of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to     reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of     care for PHP. Two practice guidelines are available to direct management patterns, but the     guidelines and recent evidence of PHP interventions are unclear about the timing and     influence of physical therapy in the multidisciplinary management of PHP. The purpose of this     investigation is to compare the outcomes and costs associated with early physical therapy     (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in     individuals with PHP. It is hypothesized that there will be greater improvement and/or     reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP     will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment     provided in the uPOD group will reflect usual management patterns and intervention will be     determined by the podiatrist. Treatment provided in the ePT group will be determined by the     physical therapist and will focus on impairment-based manual therapy and exercise to the     lower half of the body. In addition, evidence-based pain modulating modalities will be     integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle     Ability measure (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale     (NPRS), Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The     association between successful outcome based on GROC score and patient expectation of     physical therapy or podiatry, and general expectations of symptom improvement will be     analyzed. The results of this investigation will help to determine the impact of ePT to     inform practice, update existing guidelines to reduce practice variation, and identify the     most cost effective treatment for patients with PHP.   "
108509|NCT01865721|"     This study will randomise patients undergoing screening colonoscopy to receive Entonox either     continuously or as required.      Both these methods are used in the published studies of Entonox and in clinical practice.      Null hypothesis There will be no difference in pain levels between these two methods of     Entonox administration   "
108510|NCT01865708|"     Hypothesis 1: Blood alcohol concentration will be <25 mg/100ml (equivalent to a blood alcohol     concentration of <0.025%) after a 1 hour urinary catheter ethanol lock.      Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or     increased urinary white cells.   "
108511|NCT01865695|"     Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine     insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing     potential impairment on an individual's quality of life. Creon, a pancreatic enzyme     supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for     this condition. However, there has been limited work evaluating the merits of this medication     in this condition. This study aims to evaluate the benefits that Creon may have in coeliac     patients with low faecal pancreatic elastase by randomising patients with low faecal     pancreatic elastase (<200 ug/g) to either treatment with Creon or placebo. Outcome measures     that we aim to assess to determine the benefits of Creon include evaluation of stool     frequency, abdominal pain, body mass index (BMI) and quality of life.   "
108555|NCT01865110|"     This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance     improves progression free survival (PFS) compared to standard rituximab maintenance after     induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year     old) with mantle cell lymphoma.      The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28     alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of     rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).   "
108521|NCT01865565|"     Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma     tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST     patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective,     multicenter, open, observational study in evaluation of safety and efficacy of imatinib     compared with that of historical data for locally unresectable advanced GIST without     metastasis. The study will include an up to 28-day screening period, followed by receiving     imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after     surgery.   "
108522|NCT01865552|"     The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of     SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.   "
108512|NCT01865682|"     The purpose of this study is to quantify changes in ankle and knee motion and force resulting     from five progressive modifications to the anterior-posterior trim lines of thermoformed     ankle-foot orthoses (AFO). It is hypothesized that the AFO with the most anterior trim line     will prevent the most plantar flexion during loading response (the first 10% of the gait     cycle)and prevent the most dorsiflexion at terminal stance (from 30 to 50% of the gait cycle)     as compared to the non-device condition. This will be evidenced by the sagittal plane ankle     motion and ground reaction force magnitude and location during loading response and terminal     stance. Additionally, the angular velocity of knee flexion will increase during these same     periods. By contrast, as the trim lines are moved more posterior this will result in lowering     the effective stiffness of the device which will result in progressive increases in     dorsiflexion and allow increasing amounts of knee flexion during terminal stance.   "
108513|NCT01865669|"     Women with advanced maternal age and morbid obesity, have a higher incidence of labor     induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum     hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin     receptor (OTR) desensitization has been recognized in the context of prolonged labors     secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin     desensitization specifically affects contractility in women with advanced maternal age and     morbid obesity when compared to younger or normal weight populations. Further it is not known     if the higher incidence of PPH seen in these women is due to poor uterine contractility     and/or poor response to oxytocin.      The investigators hypothesize that women with advanced maternal age and morbid obesity will     exhibit poor myometrial contractility as compared to women that are younger and of normal     body habitus, in both oxytocin pre-treated and untreated myometrium.   "
108514|NCT01865656|"     To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn     Care (EmONC) skills and drills intervention, to estimate the appropriateness and     effectiveness of referrals in intervention arm compared to control arm and to calculate the     incremental cost and cost effectiveness of EmONC skills and drills intervention.   "
108515|NCT01865643|"     The aim of this study is to compare the hemodynamic response to tracheal intubations using     the standard technique versus the alternative GS intubation technique. As secondary outcomes     the investigators will analyze procedure time, success rate and injury rate.      The investigators hypothesize that the alternative intubation technique will have a shorter     procedure time and lower injury rate when compared to the standard technique of GS     intubation.   "
108516|NCT01865630|"     Subarachnoid hemorrhage (SAH) is a special type of stroke that typically results from a     ruptured intracranial aneurysm, a weakening in the wall of a blood vessel. This type of     life-threatening bleeding occurs in over 3000 Canadians per year, usually in working age     adults. Although this type of stroke accounts for only 5-10% of strokes, it contributes a     disproportionately larger percent of overall stroke morbidity and mortality due in part to     the young age of those affected. If one is fortunate enough to survive the initial bleeding     episode and the subsequent surgical treatment of the aneurysm, a patient may still develop     secondary strokes 3 to 14 days after the initial bleed. These delayed strokes are the most     significant cause of morbidity and mortality after SAH and may be potentially preventable.     Currently, there is only one medication (an anti-hypertensive) that has convincingly shown to     improve outcomes after SAH. The molecular pathway causing these delayed strokes is still not     clear, and this is an active area of research.      Animal studies have revealed that these delayed strokes may be caused by a pro-inflammation     molecule called tumor necrosis factor alpha (TNFa). Delayed strokes were prevented     experimentally by a TNFa blocker called etanercept. This clinical study, utilizing     prophylactic treatment with etanercept in patients with SAH, will ensure the safety of this     drug and determine its effectiveness in preventing delayed strokes.   "
108517|NCT01865617|"     This phase I/II trial studies the side effects and best dose of laboratory treated T cells to     see how well they work in treating patients with chronic lymphocytic leukemia, non-Hodgkin     lymphoma, or acute lymphoblastic leukemia that have come back or have not responded to     treatment. T cells that are treated in the laboratory before being given back to the patient     may make the body build an immune response to kill cancer cells.   "
108518|NCT01865604|"     The aim of the study is to investigate whether there is a polarity-specific influence of tDCS     on cerebral vasomotor reactivity monitored by transcranial doppler sonography.   "
108519|NCT01865591|"     The aim of this study is to assess the potential therapeutic benefit of catheter-based renal     sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility     trial.   "
108520|NCT01865578|"     Patients suffering from anti-NMDA receptor encephalitis show impaired NMDA-receptor dependent     neuronal transmission. Furthermore, they often have cognitive deficits of different     magnitude. Impaired neuronal signaling of NMDA-receptors very likely result in decreased     cortical synaptic plasticity. Thus, this represents one major reason of cognitive deficits.     Synaptic plasticity can be assessed in humans via the non-invasive technique of transcranial     magnetic stimulation (TMS).      The current study aims to investigate whether learning ability and also cortical plasticity     can be changed by applying sessions of transcranial direct current stimulation (tDCS).     Therefore, we are recruiting 10 to 15 patients suffering from anti-NMDA receptor encephalitis     as well as healthy controls in order to compare tDCS effects. Learning ability is assessed by     motor sequence tasks, whereas cortical plasticity is measured via TMS.      tDCS is a novel non-invasive technique allowing induction of changes in cerebral excitability     level and also cortical plasticity. Previous studies showed positive outcome of anodal     stimulation on learning tasks. Especially motor learning seems to be an important target for     tDCS treatment since it showed best results for both post-stroke patients and healthy     subjects. Multiple sessions of tDCS are inducing long-term effects and improved learning     function, which were present three months after stimulation.      In this study we hope to reveals new insights into the pathomechanisms of impaired cognitive     and learning abilities in patients having anti-NMDA receptor encephalitis. Moreover, we     evaluate whether tDCS is an effective treatment for patients with cognitive and learning     deficits.   "
108556|NCT01865097|"     Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome     non-motor symptom is pain. Currently these symptoms are treated with medication with limited     success. Our study aims to determine whether relaxation guided imagery can alleviate pain in     Parkinson's disease patients.   "
108524|NCT01865526|"     The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic     kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are     complex and the patients' compliance is very low. A dietary interview method is a validated     instrument to evaluate the patients' compliance; however, it the presence of a dedicated     dietitians. For these reasons, and because of the absence of dedicated dietitians in many     nephrology centres, it is usual practice to give standard low protein diets to CKD patients     not on dialysis.      Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and     sodium intake in patients with CKD, as compared to the practice of giving a low protein diet     elaborated by a renal dietitian.   "
108525|NCT01865513|"     International multicenter observational study of a random-sample cohort of patients     undergoing any in-hospital surgical procedure under general or regional anaesthesia during a     continued 14-day period of recruitment.      Primary hypothesis of this study is that the use of muscle relaxants, their reversal agents,     or neuromuscular monitoring increases the incidence of postoperative pulmonary complications.     The secondary hypothesis is that the use of muscle relaxants increases in-hospital mortality.   "
108526|NCT01865500|"     Chronic obstructive pulmonary disease (COPD) is a common disease that has a chronic and     progressive course. Patients with COPD may have exacerbations one to four times in a year.     Numbers of exacerbations are important because of increased morbidity and mortality and     healthcare costs.      Systemic corticosteroids (SC) are recommended in the management of exacerbations of COPD as     well as bronchodilator, oxygen and antibacterial treatment by all international guidelines.     However, there are still some concerns about systemic corticosteroid use because COPD     patients are older and relatively immobilized. In addition, exacerbation rate is     significantly higher in a group of COPD patients, and these patients need higher amounts of     SC in order to control of exacerbation. It results in some adverse effects such as     osteoporosis and bone fractures, thinning of the skin, posterior subcapsular cataract     formation, glucose intolerance and myopathy. Thus, this condition leads clinicians to seek     alternative options. However, there are few studies showing that nebulized steroids (NS) are     as effective as SC in exacerbations of COPD and the optimal NS dose is not certain.      The investigators aimed to determine the optimal NS dose and evaluate the efficacy and safety     of NS compared with SC in the treatment of patients with COPD exacerbations requiring     hospitalization.   "
108527|NCT01865487|"     This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and     regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV     negative, and have no history or evidence of TB disease. The investigational product is     AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is     administered by IM injection.   "
108528|NCT01865474|"     This is a prospective, double-blind, randomized, and controlled study. The investigational     product, DLBS1033 at a dose of 490 mg thrice daily or placebo, will be given for an 8-week     course of therapy.      DLBS1033 effectively demonstrated fibrinolytic, fibrinogenolytic as well as antithrombotic     activities. Hypercoagulation state with high fibrinogen level is usually found in diabetes     mellitus patients.      Therefore, the hypothesis of interest of this study is that DLBS1033 will reduce fibrinogen     level of diabetes mellitus patients better than that of the Control Group.   "
108529|NCT01865461|"     MRI, without any contrast injection, allows a non-invasive evaluation and quantification of     hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads,     but in certain clinical circumstances, cases require to improve performances. The aim of the     study is to add to MRI scans which currently must be performed innovative sequences     appropriate for the clinical question to overall appreciate on a varied range of patients     their quality, their robustness, their relative performance and, for patients having a     biopsy, their accuracy.   "
108530|NCT01865448|"     Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to     assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to     increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the     biological markers of chronic inflammation in obese patients following a weight-loss     programme.   "
108531|NCT01865435|"     Actually, there is an increasing number of arguments for a premature origin of chronic     adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors     interacting with the foetal or postnatal lung growth are associated with early and     long-lasting respiratory functional changes susceptible to contribute very significantly to     the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena     of premature cellular senescence, recently involved in the physiopathology of the COPD. An in     utero exposition to cigarette smoking is one of these situations, because it is known to     induce, not only functional respiratory changes, but also multiple diseases in the child     which could testify of cellular ageing phenomena.      Our project aims to demonstrate that in utero smoking is associated with markers of premature     cellular senescence in newborn children      The study will be driven in human newborn child's, with comparison of the length of the     telomeres in circulating lymphocytes (umbilical blood is collected), according to the     exposure in in utero smoking and also according to the degree of hypotrophy. This study will     be a pilot study completed by an animal experimental study.   "
108557|NCT01865084|"     The main purpose of this study is to determine if tadalafil can slow the decline in walking     ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the     safety of tadalafil and any side effects that might be associated with it in boys who have     DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks     of the study, and can then continue into an open label extension (OLE) that consists of two     periods during which all participants will receive tadalafil. In OLE period 1, all     participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will     continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.   "
108558|NCT01865071|"     Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer   "
108665|NCT01863680|"     The primary objective of this trial is to demonstrate the non-inferiority of the clinical     pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization     (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology [JSOG]     2009 registry data: 24.3 percent [%]). The secondary objectives of this trial are to assess     the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.   "
108532|NCT01865422|"     Cough is one of the most common reasons for consultation. Even if cough is a non-specific     symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated     that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to     evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL     chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A. B.      Objective : The aim of the study is to validate the French version of the PC-QoL, a     parent-proxy QoL chronic cough specific questionnaire.      Methods : Linguistic validation will be performed using backward/forward translation     guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested in     150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (> 4 weeks);     18 years of age or younger; all etiologies excepting cystic fibrosis. Informed consent from     parents will be obtained. At enrollement, each parent will fulfill the PC-QOL questionnaire     and two cough-related measures (visual analogue score, verbal category descriptive). Clinical     data (medical history, physical examination) will be collected. Children QoL will be assessed     using VSPA, Kidscreen and Qualin questionnaires. For assessing reproductibility and     sensitivity to change, parents will be retested 7 and 21 days later. Content validity,     construct's validity, external validity and instrument's reliability will be explored.   "
108533|NCT01865409|"     Physiological processes leading to a preterm infant to be able to feed orally has not been     fully understood. The investigators hypothesized that maturation of autonomic nervous system     may play a major role in this process and kangaroo care may accelerate this maturation. The     investigators will use heart rate variability to measure the maturation of autonomic nervous     system.   "
108534|NCT01865396|"     The World Health Organization (WHO) defines palliative care as an approach to improve the     quality of life of patients and their families facing life-threatening illness, through     prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO     stresses that palliative care is applicable early in the course of the illness together with     other therapies that are intended to cure or prolong life, such as chemotherapy or radiation     therapy. For the benefit of the patient, palliative care is however often given (too) late in     the course of the disease of incurably ill patients.      The aim of our study is to measure the effect of interventional palliative care on quality of     life, mood and end-of-life care of patients with advanced cancer and their families. These     patients have a limited life expectancy and a high symptom burden, this leads us to suggest     that these patients may be benefited with palliative care soon after diagnosis of metastatic     disease (interventional palliative care).      The research design of this study is a randomized controlled trial with, on the one hand, an     intervention group in which patients and their families receive interventional palliative     care in combination with standard cancer care and on the other hand a control group in which     patients and their families receive only standard oncologic care. Participants in the     intervention group will meet the palliative support team shortly after diagnosis. Afterwards,     the palliative support will meet them at least once a month. This intervention focuses on     topics such illness understanding, symptom management, decision making and coping with the     disease. Participants in the control group will only meet with the palliative support team at     the patient's own request or after referral by the oncologist or the nursing staff.   "
108535|NCT01865383|"     Young men who are members of the camps randomized to receive a microfinance and health     leadership intervention will have a lower incidence of sexually transmitted infections     (Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) and     report perpetrating less physical or sexual violence against sexual partners as compared to     young men who are members of camps not randomized to receive the intervention.   "
108536|NCT01865370|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids.     The investigators measured improvement of blood lipids parameters , including Total     Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.   "
108537|NCT01865357|"     Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS).     Cognitive deficiencies could occur at this early stage and concern mainly information     processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor     Imaging (DTI) can help in the understanding of these mechanisms.   "
108538|NCT01865344|"     To provide a preliminary evaluation of the correlation between Numeric rating Score (NRS) and     skin conductance responses per second at rest and in response to a painful stimulus.     Sensitivity and specificity will be calculated for NRS and skin conductance responses per sec     to a standardized painful stimulus. Furthermore, predictors of pain will be examined.   "
108539|NCT01865331|"     This trial is conducted in Europe. The aim of this trial is to investigate safety,     tolerability and pharmacokinetic (the exposure of the trial drug in the body) and     pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin     degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM),     both explorative formulations, not similar to the proposed commercial formulation, in healthy     male Japanese subjects.   "
108540|NCT01865318|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec     (insulin 454), an explorative formulation, not similar to the proposed commercial     formulation, under single-dose and steady-state conditions in male subjects with type 1     diabetes.   "
108541|NCT01865305|"     This trial is conducted in Europe. The aim of this trial is to compare different ratios of     explorative formulations, not similar to the proposed commercial formulation, of IDegAsp     (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately     injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared     with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.      Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with     type 1 diabetes where each subject will be randomised to five out of the ten possible     treatments. Each treatment consists of an injection of the insulin product followed by a     euglycemic clamp with a washout period of 7-15 days between treatments.      Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with     type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a     euglycaemic clamp with a washout period of 7-15 days between treatments.   "
108544|NCT01865266|"     Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in     ventilated critically ill patients specially in intensive care unit (ICU). It is associated     with an increased duration of mechanical ventilation, high death rates and increased     healthcare costs in the development country.      Although VAP is preventable and many practices have been demonstrated to reduce the incidence     of this disease, the morbidity is still so high. VAP is hard to cure and the mortality is     about to 40% which was reported in China in 2004. If the bacteria of     multidrug-resistance(MDR) is isolated, the mortality can increase to 70%. So much more     methods should be needed in treating VAP in addition to using antibiotics.      Ulinastatin is a serine protease inhibitor with a molecular weight of 67,000 found in healthy     human urine. It is used worldwide for patients with inflammatory disorders, including     disseminated intravascular coagulation(DIC),shock, and pancreatitis . Furthermore,     ulinastatin administration can help reduce sepsis, prevent multiple organ dysfunction, and     modulate immune functions.      Actually, three studies have showed that ulinastatin treatment is associated with reduced the     levels of inflammatory factors in blood serum in patients with acute respiratory distress     syndrome(ARDS).Though analyses of serum inflammatory factors such as tumor necrosis factor     (TNF)-α and interleukin (IL)-6 have been used to determine the degree of systemic     inflammation under various clinical conditions, they can not reflect the degrees of lung     infection directly.      Basing on the results of previous studies, meta analyses and system reviews, the     investigators hypothesized that the anti-inflammatory function of ulinaststin may also     decrease the levels of inflammatory factors in bronchoalveolar lavage(BAL) fluid in Patients     with VAP.      In addition there is no prospective study to investigate the role of ulinastatin in BAL. The     investigator hopes that this study can approve the relationship between ulinastatin and     inflammatory factors in BAL. And it can improve the processes,outcomes and costs of critical     care as well.   "
108545|NCT01865253|"     This is an observational proof of concept study investigating the safety and effectiveness of     renal denervation to lower blood pressure in people whose blood pressure is not adequately     controlled due to:        -  intolerance to antihypertensive medication        -  inability to take antihypertensive medication due to planned pregnancy        -  renal artery stenosis        -  chronic kidney disease        -  non-compliance to antihypertensive medication      A total of 125 participants, 25 from each of the groups mentioned above will be recruited to     the study.      The duration of this study is 36 months.   "
108546|NCT01865240|"     This is a study investigating the effectiveness of renal denervation in lowering blood     pressure in people whose blood pressure is not adequately controlled despite treatment with 3     or more blood pressure lowering drugs. The study is designed to compare the effects of renal     denervation to a usual care group receiving additional blood pressure lowering drugs.   "
108547|NCT01865227|"     Obesity has become a global epidemic causing enormous human and economic costs. Incidence     rates have doubled over the last few decades and obesity-related illnesses such as diabetes     and cardiovascular diseases now constitute one of the major contributors to the global burden     of disability. Overall, obesity has been recognized as one of the most pressing public health     concerns worldwide and effective treatment and prevention strategies are urgently required.     While behavioral and pharmacological treatments (e.g.low calorie diets, medication) are     successful means for overcoming overweight and mild obesity, more severe cases of obesity     usually fail to respond to such interventions. As a result, the demand for weight loss     surgery is growing among this population. However, uncertainties about the effectiveness of     obesity surgery persist and high relapse rates (i.e. weight regain) are common. Further     research in this field is needed to identify risk factors that may trigger relapse and to     understand patients' treatment needs in greater depth. Previous studies have pointed toward     high levels of mental health problems among patients. However, the impact of preoperative     psychopathology on actual surgery outcomes remains unclear. Similarly, few studies have     investigated the effect of postoperative therapy on patients' psychological functioning and     weight loss patterns. Research addressing these gaps is imperative to establish best-practice     approaches. This challenge applies in particular to Middle East and North Africa(MENA)     countries where research in the field of bariatric surgery and related mental health is     largely missing. This is a major concern given the fact that the MENA region experienced the     highest increase in overweight and obesity in recent decades compared to other countries.      The proposed study aims to address this deficiency by examining obesity surgery patients in     two Arab countries (UAE and Jordan). The goals of the project are to investigate the nature     and extent of psychological health concerns among these patients before and after surgery and     potential associations with treatment outcomes. Moreover, it will test the efficacy of     post-operative counseling to improve weight loss and psychological health. For this purpose,     a randomized clinical trial design will be employed so that cause and effect relationships     between postoperative counseling and treatment outcomes(i.e. weight loss and psychological     functioning) can be examined experimentally. The study will start by assessing participants'     psychological health prior to surgery by using standardized self-report measures.      After surgery, participants will be randomly assigned to either the intervention condition     consisting of 3-monthly post-operative medical checkups plus group counseling or the     treatment as usual condition (i.e. 3-monthly standard medical checkups only). Additionally,     participants' psychological health will be reassessed in both groups at 3, 6, 9 and 12 months     after surgery. The benefit of the experimental study design is that it allows comparing     patient outcomes between groups while at the same time controlling for a wide range of     potential confounding variables.      The data collected are expected to make a significant contribution to the treatment challenge     of one of the most pressing public health concerns worldwide. Study results will add to     clinical practice by broadening and deepening our knowledge of the treatment needs of obese     patients. By identifying psychological health concerns that may threaten successful treatment     outcomes high-risk patient groups can be recognized early, which in turn may help to reduce     postoperative weight regain and other complications.      To the best of the PI's knowledge, the proposed work would be the first study of this kind in     the Arab world. Findings will be helpful for developing culturally sensitive and     evidence-based best-practice guidelines, which are vital to achieve satisfying long-term     outcomes. Moreover, study results will be relevant for research communities and practitioners     outside the MENA region since empirical support for the effectiveness of obesity surgery     remains weak internationally.   "
108548|NCT01865201|"     It is hypothesized that excessive generation of free radicals involves in the pathogenesis of     radiation-induced brain necrosis. This study therefore evaluated the effect of free radical     scavenger, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients with     nasopharyngeal carcinoma (NPC) after radiotherapy.   "
108549|NCT01865188|"     To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in     combination with amlodipine in patients with essential hypertension.   "
108550|NCT01865175|"     This is a pilot study designed to compare the tolerance of ionic iron (ferrous sulphate) with     heme iron polypeptide. Subjects will take one week of one product followed by a week with no     product followed by a week with the other product. Subjects will complete a daily diary to     assess side effects.      Hypothesis: Heme iron polypeptide is associated with fewer gastrointestinal side effects than     ionic iron.   "
108551|NCT01865162|"     The first weekly KD meal package will be given to the patient at the study site. The patient     will be instructed in how to process the week-long meal plan package content. Participants     will measure urine ketone bodies with Ketostix 2x day and blood for glucose and ketone levels     using self-administered Precision Xtra® Meter (Abbot Diabetes Care, Alameda, CA, USA)     starting with the first day of the diet. Self-administered blood checks for glucose and     ketone bodies will be done in fasted state in the morning and 2 hours post-prandially in the     evening. Participants will be seen on day 7 of treatment by the study nutritionist and a     study investigator-physician (separately) to review possible AEs, and for further education     about the diet. Study staff will review and evaluate the participant's method of urine ketone     and blood glucose and ketone levels testing. Subsequently, participants will be seen at one,     2 weeks, and 4 weeks after KG diet initiation, and then monthly. KD treatment will last until     exit criteria are met or for 6 months, whichever comes first. Exit criteria are the primary     outcome measures, the first of either (a) cerebral edema requiring steroid rescue therapy or     (b) death.      Treatment will occur in outpatient office setting at the Mid-Atlantic Epilepsy and Sleep     Center, Bethesda, MD. The location of subsequent treatment administration may change to     hospital setting at Holy Cross Hospital should a patient need hospitalization during the     study for any reason, as determined by the patient's clinical care needs.   "
108552|NCT01865149|"     Studies in patients with intracranial hypertension have shown a good relationship between     optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured     intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath     diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.   "
108553|NCT01865136|"     The aim of this project is to study the safety, efficacy and effectiveness of medical     treatment of incomplete abortion provided to women by physicians or midwives in Kisumu,     Kenya.      In Kenya, Post Abortion Care (PAC), provided by physicians, nurse-midwives and clinical     officers, has been integrated at private reproductive health facilities since 1998.     Misoprostol as treatment of incomplete abortion was launched I Nyanza Province in April,     2012. The involvement of midwives in medical (Misoprostol) treatment of incomplete abortion     has, however, not been systematically evaluated. There is a need to determine whether     midwives and physician can perform medical treatment of incomplete abortion equally safe and     effective in Kenya. The results will thus provide evidence-based information that can     contribute to the development of strategies to increase women's access to Post Abortion Care     in Kenya as well as in other low-income contexts.   "
108554|NCT01865123|"     The purpose of this study is to compare the effectiveness of the Transcendental Meditation     (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure     (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month     treatment period.   "
108598|NCT01864551|"     The investigators hypothesized that olanzapine will be superior to lamotrigine in the     prevention of any kind of recurrence of bipolar disorder. On the other hand, lamotrigine     group will have better prevention of depressive episode than olanzapine group. Meanwhile, the     investigators supposed that there will be more concomitant medicine in lamictal group than     olanzapine group. The comorbidity will influence the measurement of outcome such as time     period of recurrence of depressive episode in both groups..   "
108559|NCT01865058|"     Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with     approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark     accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of     chemotherapy and monoclonal antibodies has significantly improved prognosis over the past     decade, but a large proportion of patients with DLBCL will continue to relapse with our     current treatment options. Therefore, there is a need for reliable methods for detection of     treatment response as early as possible in the treatment course in order to identify patients     who respond poorly to standard treatment and potentially would benefit from a change in     treatment strategy. This has still not been established, but a valid early marker is required     in order to allow randomized trials of treatment stratified by early response. One of the     most promising applications of PET is the metabolic assessment of the early response of     cancer treatment.      This study is a national prospective multicenter study emanating from the Danish Lymphoma     Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim     is to establish the correct timing of response evaluation. Additionally, the investigators     wish to investigate the optimal qualitative and quantitative method of response assessment in     order to predict post-therapeutic remission and long-term prognosis.This study will     contribute to interim-PET being implemented in the most optimal way in daily clinical     practice.   "
108560|NCT01865045|"     This is a multicenter retrospective analysis .The aim of the present study is to investigate     the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients     and evaluate the possible impact on clinical outcome.      Sample size: around 150 patients based on the availability of tumor size   "
108561|NCT01865032|"     This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus     the gold standard for Leishmania diagnosis in the US which is microscopic identification of     Leishmania amastigotes in a stained lesion sample. Subjects will be patients who present for     dermatology consultation with a primarily ulcerated lesion. After informed consent is     obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected     from the subject's lesion in the following order: 1) one sample will be obtained with a     dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained     by scraping for use in the microscopic identification of amastigotes. Samples will be     analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed     by different operators who are clinical staff members. These staff members, blinded to each     other's results, will evaluate the samples from each method independently. Each of the 150     study subjects will be followed administratively to the point where a diagnosis is     established (if possible) for their tested lesion, even if that diagnosis is not cutaneous     leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the     investigator will assign a likely etiology (eg, infectious, oncological, immunological,     vascular, or undetermined/other origin). Based on the diagnosis determined for each lesion,     subjects will be referred for appropriate treatment.   "
108562|NCT01865019|"     pressure controlled ventilation will improve oxygenation indices , hemodynamics during     anesthesia for living donor liver transplantation recipients ,improving postoperative graft     function and decreasing postoperative pulmonary complications   "
108563|NCT01865006|"     The purpose of this study is to compare effect of sutureless thyroidectomy with vessel     closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric     evaluation.   "
108564|NCT01864993|"     Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal     symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents     an important issue in health care. Actually it remains difficult to diagnose and prove due to     the lack of established criteria. The investigators intention is to establish a diagnostic     flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from     functional gastrointestinal symptoms.   "
108565|NCT01864980|"     Certain types of surgery are associated with occult blood loss, which is hard to detect     intraoperatively by intermittent conventional, invasive Hb concentration measurements using     the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The     investigators want to see whether continuous non-invasive transcutaneous Hb measurement using     a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb     is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell     concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly     associated with transfusion below a critical haemoglobin concentration. Furthermore, the     investigators want to study if SpHb monitoring changes the timing of RBC administration and     reduces the need for intra- and post-operative RBC transfusion.   "
108566|NCT01864967|"     Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and     subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating local     nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor     and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow in     chronic wounds of the lower limbs.   "
108599|NCT01864538|"     The primary objective of this study is to determine the response rate, duration of     response,progression-free survival and overall survival of subjects with advanced melanoma     treated with TH-302.   "
108654|NCT01863823|"     1. Gastric eradication has no effective on oral H. pylori infection.        2. Treatment of oral infection increase success rate of eradication on stomach infection.   "
139734|NCT01455649|"     The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus,     with its onset after 3 months of treatment with calcineurin inhibitor.   "
108567|NCT01864954|"     This study seeks to develop and test a Web-based tobacco relapse prevention program targeting     postpartum women who quit smoking for pregnancy. Participants are randomly assigned to one of     two conditions: (1) an Enhanced Web+phone Condition that receives access to an interactive     Web-based intervention plus up to 3 brief supportive phone calls from a personal coach; (2) A     Basic Web Information-Only Control Condition that receives access to an informational website     plus an introductory phone call. The hypothesis is that Women in the Enhanced Condition will     be more successful in avoiding tobacco relapse than women assigned to the Basic Control     Condition.   "
108569|NCT01864928|"     Despite abundant evident supporting the use of acute reperfusion therapy in the setting of     acute ischemic stroke (AIS), adoption of this practice in routine clinical care is poor. We     hypothesize that a significant barrier is the difficulty in weighing the benefits and risks     of rt-PA treatment in the care of an individual patient, a problem compounded by the time     urgency of decision-making and clinical fears that weigh risks of treatment more heavily than     benefits.      The goal of this Quality Improvement (QI) study is to leverage an IT solution that we have     developed, ePRISM, that executes multivariable risk models with patient-specific data so that     a personalized estimate of an individual's outcomes (both risks and benefits) with and     without rt-PA, can be generated so support safer, more effective clinical care. Through an     earlier project, we will have programmed ePRISM with the best available risk-stratification     models and developed a clinically useful format for presenting the data to support clinical     decision-making in AIS.      Through QI, we propose to identify the optimal mechanism for integrating the tool within the     routine flow of patient care in preparation for more definitive studies, or dissemination     strategies, to improve the treatment of patients with AIS.   "
108570|NCT01864915|"     Colon capsule endoscopy is a new technology that is a noninvasive method of examining the     large bowel. The bowel preparation required for this test differs from colonoscopy in that it     needs to clean the colon but also needs to provide propulsion. Most published studies have     used medications as part of their regime that are not available in parts of North America     (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp     detection rates.      Objective: In this study a bowel preparation for the colon capsule is proposed that uses     medications approved for use in Canada that may provide a better preparation quality and     better completion rates.      Methods: Patients who are being referred for a colonoscopy will be recruited to participate     in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel     preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four     days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride     2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study.     The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior     to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by     two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation     using a previously defined scale and examine for polyps. We propose that administering     Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule     completion rates and a booster dose of Picosalax will improve colon capsule completion rates     compared to prucalopride by itself.   "
108571|NCT01864902|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous or donor-derived T cells may make the body build immune response to     kill cancer cells.      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in     treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem     cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.   "
108572|NCT01864889|"     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory     into patient autologous or donor-derived T cells may make the body build immune response to     kill cancer cells.      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in     treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell     transplantation or intensive chemotherapy) or refractory to chemotherapy.   "
108573|NCT01864876|"     This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and     tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF     administered subcutaneously. The second focus will be to detail the global immune response by     measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be     to investigate the effects of GLA on the peripheral blood immune cells including monocytes     and dendritic cells. The results of this trial will generate supportive human data to use GLA     as an adjuvant in a dendritic cell-targeted vaccine strategy.   "
108574|NCT01864863|"     The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets     and one HGP1206 125 mg tablet in healthy male volunteers.   "
108575|NCT01864850|"     Randomized comparison between standard radiotherapy and hypofractionated split course     schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated     split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment,     acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the     same efficacy, measured by the locoregional control rate.   "
108576|NCT01864837|"     The aim of the proposed study is to investigate the agreement between the measurement of the     tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue     coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM).   "
108600|NCT01864525|"     Essential voice tremor is a neurological condition that produces a regular, shaking quality     in the voice. One form of drug treatment that produces some improvement in tremor of the     hands is octanoic acid, which is a food additive that is similar to alcohol. Research     suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no     intoxication effects. This study will determine whether octanoic acid may be useful for     reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid     will reduce the effects of tremor on the voice.   "
108577|NCT01864824|"     In this study, the pills formulated are being used to try to ameliorate the effect of air     pollution on epigenetic changes, specifically DNA methylation, potentially linked with     particulate matter air pollution inhalation and cardiovascular health effects. The way in     which this is achieved is that the vitamins, which act as methyl donors, add a methyl group     to the DNA to reverse the loss observed on exposure to air pollution.      Specifically for this study, the methyl donor supplement has been made by Jamieson     Laboratories, and consists of 50mg Vitamin B6 and 1 mg Vitamin B12, (both within Health     Canada approved limits) and 2.5 mg folic acid. The non-vitamin ingredients are those commonly     used in pill formation. However, the folic acid concentration is 2.5mg, which is above the     1.0mg limit set by Health Canada for a natural health product. This concentration, however,     has been used in previous academic studies safely and effectively, and was also formulated by     Jamieson Laboratories. (ClinicalTrials.gov number, NCT00106886; Current Controlled Trials     number, ISRCTN14017017. HOPE2 study).   "
108579|NCT01864798|"     This is a prospective, single arm phase IIa trial in which patients with early breast cancer     will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart     (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be     collected at baseline and at surgery. Post-operative treatment will be at the discretion of     the investigator.      Primary objective: to determine if a short course of RANKL inhibition with denosumab can     induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry     (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women.      Secondary objectives:        -  To determine the number of absolute Ki67 responders after a short course of denosumab          (defined as <2.7% IHC staining in the post treatment tumor biopsy).        -  To determine the effects of a short course of denosumab on serum C-terminal telopeptide          levels (CTX).        -  To determine the effects of a short course of denosumab on RANK/RANKL gene expression          and signaling as assessed by immunohistochemistry (IHC) and gene expression profile in          the tumor.        -  To determine the effect of a short course of denosumab on tumor apoptosis rates using          IHC        -  To determine the effect of a short course of denosumab on modulating the immature          mammary epithelial cell populations in the tumor.        -  To determine the effect of a short course of denosumab on estrogen signaling pathways in          the tumor.        -  To determine the effect of a short course of denosumab on various immune - To determine          effect of safety profile of denosumab   "
108580|NCT01864785|"     Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are     composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains     controversial. Treatment varies from the conservative management to various types of surgery.     Internal fixation with spinal fusion is a surgical treatment method that is generally     accepted for patients with thoracolumbar fracture. In this department, the investigators     treat thoracolumbar burst fracture with posterior fixation alone and combined with articular     process fusion. To evaluate the result of the two kinds of treatment, the investigators     design this clinical trial. So, the investigators compared the radiological and clinical     outcomes between patients who underwent posterior fixation alone and supplemented with fusion     following the onset of thoracolumbar burst fractures.   "
108581|NCT01864772|"     The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of     autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or     metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty     (after geriatric assessment).   "
108582|NCT01864759|"     The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in     adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally     replicative or oncolytic adenovirus.   "
108583|NCT01864746|"     The PENELOPEB study is designed to demonstrate that in the background of standard     anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS)     compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early     breast cancer at high risk of relapse after showing less than pathological complete response     to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in     patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an     attractive option with a favourable safety profile for these patients.   "
108584|NCT01864733|"     The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite     medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an     independent risk factor for mortality and complications. Up-to-date, interventional studies     involving nutrition are scarce in CHF. Academic societies are recommending the use of oral     nutritional supplements (ONS) in case of weight loss, without defining the modalities. ONS     could improve nutritional status in undernourished CHF patients, but solely administered,     have a limited impact on undernutrition, physical performance and prognosis. A multimodal     approach integrating physical exercise, nutritional intakes, polyunsaturated n-3 fatty acids     (n-3 PUFA), and anabolizing hormones, has to be privileged. A recent trial has shown the     clinical benefits of such an approach in patients with chronic respiratory insufficiency     (CRI), who have similar nutritional and muscular characteristics.      Exercise rehabilitation is well validated in CHF patients, but has never been validated in     case of undernutrition. Exercise rehabilitation allows improving exercise capacity, quality     of life and cardiovascular outcomes including mortality.      N-3 PUFA supplementation improves muscle strength and endurance in CRI patients. n-3 PUFA     supplementation decreases by 30% cardiovascular mortality of CHF patients. n-3 PUFA could be     useful for CHF patients rehabilitation.      Androgenopenia is a prognostic factor in CHF. Androgen substitution improves significantly     muscle strength, walking endurance and quality of life. In the context of a multimodal     approach, Androgen substitution together with exercise rehabilitation and ONS could have a     beneficial effect on muscle mass, strength and endurance of CHF patients, as already     described in CRI, elderly and HIV patients.      The study hypotheses that a 3-month multimodal approach associating exercise rehabilitation,     androgen substitution, n-3 PUFAs and ONS improves exercise capacity of undernourished CHF     patients.   "
108601|NCT01864512|"     This project was undertaken by Qilu Hospital of Shandong University and other well-known     hospitals in China. In order to report the alteration of Different Immune Parameters in ITP     Patients Receiving Eltrombopag Treatment.   "
108661|NCT01863732|"     This 3-year extension study aims at making available the treatment with secukinumab in     prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III     study CAIN457F2305, defined as core study, as well as to generate additional data on the     sustainability of clinical benefits, safety and tolerability during long-term administration     of secukinumab.   "
108602|NCT01864499|"     Neurosurgery for supratentorial brain tumor is frequently associated with preoperative     intracranial hypertension. The evaluation of intracranial pressure is available noninvasively     by measuring the diameter of the optic nerve sheath ultrasound.      The evaluation of intracranial pressure by measuring the DNO in perioperative is not     described in the literature. The investigators propose a pilot study to assess intracranial     pressure perioperative surgery for supratentorial brain tumor. The investigators consider a     diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20     mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal     healthy adult unanesthetized is 5 mm.      The main objective of the study is to compare the mean change in diameter of the optic nerve     between the postoperative and D2 between groups of patients undergoing resection of a brain     tumor and patients undergoing biopsy brain tumor.      Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients     is estimated according to the recruiting capabilities of neurosurgery for this type of     patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control     group: 20 patients Biopsy Brain Tumor.   "
108603|NCT01864486|"     This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System     (IRIS V1)   "
108585|NCT01864720|"     Insomnia is very common in cancer patients. When left untreated, insomnia can lead to     numerous serious consequences (e.g., psychological disorders) for the individual and     significant costs for society (e.g., increased medical consultations). Cognitive-behavioural     therapy (CBT), a form of psychotherapy, is now considered the treatment of choice for     insomnia and its efficacy has been demonstrated in clinical studies conducted in cancer     patients. Unfortunately, CBT for insomnia (CBT-I) is not widely accessible as only a few     cancer clinics have mental health professionals formally trained in the administration of     this treatment. Innovative models of treatment delivery are therefore needed to make sure     that every cancer patient with insomnia receives the care he/she needs. A stepped care     approach in which patients only receive the level of treatment that they need, beginning with     a minimal, less costly, intervention followed by more intensive treatment if required, has     shown some promises for other psychological disorders (e.g., depression). Although its     relevance has been emphasized to make CBT-I more accessible, its utility has never been     investigated. The main goal of this randomized non-inferiority study is to assess the     efficacy and costeffectiveness of a stepped care CBT-I as compared with standard care. Our     hypothesis is that a stepped care approach will not be statistically inferior in terms of     efficacy as compared to usual care, while being much less costly (better cost-effectiveness     ratio). Three hundred cancer patients (mixed cancer sites) with insomnia symptoms will be     assigned to: (1) stepped care CBT-I (n = 200) or (2) standard care (n = 100), consisting of 6     weekly sessions administered individually by a professional.   "
108586|NCT01864707|"     The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based     stress reduction is more efficacious than usual care only to reduce fatigue in patients with     multiple sclerosis.   "
108587|NCT01864694|"     The aim of this study is to compare a Web-based system and a computer telephone system to     determine their effectiveness in improving diet behaviors compared to each other and a     control group.   "
108588|NCT01864681|"     The purpose of this study is to determine whether metformin in combination with gefitinib are     effective in patients with previously untreated advanced or metastatic Non-Small-Cell Lung     cancer with epidermal growth factor receptor (EGFR) mutations   "
108589|NCT01864668|"     Measure the lung strain in different tidal volume in ADRS patients to find the relationship     between tidal volume and lung strain and find the most suitable tidal volume for each     patient.   "
108590|NCT01864655|"     Alzheimer's disease is a devastating neurodegenerative disorder, for which there is currently     no effective treatment to slow or halt progression. Beta amyloid peptide accumulates in the     brains of those with Alzheimer's, and is thought to play a major role in triggering the     dementia. The investigators recently characterized a molecular pathway by which ß-amyloid     damages neurons, and showed that the protein termed Fyn kinase is crucial. Our data suggest     that blocking Fyn will have a significant therapeutic benefit for Alzheimer's. Astra Zeneca     has developed a blocker of Fyn and related kinases (AZD0530) for the treatment of cancer.     Chronic AZD0530 administration is well tolerated in humans, and the investigators propose to     test its potential as a novel Alzheimer's disease modifying therapy. This study will assess     the safety and tolerability of AZD0530 in patients with Alzheimer's disease.   "
108591|NCT01864642|"     The hypothesis is that osteopathic manipulative treatment (OMT)will significantly reduce     intraocular pressure (IOP) in individuals with ocular hypertension (OHT) and glaucoma suspect     patients.   "
108592|NCT01864629|"     The purpose of this study is to examine the effectiveness of focused family planning     counseling on the uptake and continuation of highly effective contraceptive methods (defined     as the intrauterine device, implant, and both male and female sterilization methods including     vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently     experienced a preterm delivery.      The investigators hypothesize that women with a recent preterm birth (PTB) will be more     likely to initiate and continue using a highly effective method of contraception when     provided with focused family planning counseling.   "
108593|NCT01864616|"     The purpose for this study is to determine the effect of vitamin D supplementation on disease     activity in Crohn's disease patients in Canada and Saudi Arabia   "
108594|NCT01864603|"     The SEARCH study aims to test evidenced-based innovative community based interventions that     lead to the elimination of HIV in rural communities in East Africa using a multi-disease     approach. The first phase of the study will quantify the health, economic and educational     impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy).     This first phase will be completed in July 2017. The second phase of the study, will quantify     the health, economic and educational impact of targeted Pre-Exposure Prophylaxis (PrEP),     targeted HIV testing and targeted care interventions in the context of universal treatment     and streamlined care. This second phase will be completed in July 2020. The study     intervention is designed to improve the entire continuum of care, to reduce structural     barriers for all populations including those most at risk.   "
108595|NCT01864590|"     The open abdomen is a valid and accepted surgical tactic for the trauma and acute care     patient. There have been many mechanisms described for its management, but the most accepted     strategy is the vacuum pack. At our hospital the investigators have used for many years a     double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial     operation. At subsequent surgeries once the abdomen is clean the investigators leave the same     subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the     investigators try to tighten the mesh with sutures until the abdomen can be closed. This     study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to     determine which is related to a higher fascial closure rate.   "
108596|NCT01864577|"     The purpose of this study is to determine whether the use of negative pleural suction in tube     thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or     hemothorax in patients with chest trauma.   "
108597|NCT01864564|"     Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese     women (body mass index ≥30.0) will result in improved perinatal outcomes.      Specific Aim 2: To test the hypothesis that a lower diagnostic threshold for GDM at 14-18     weeks will result in improved detection of GDM and reduce the need for third-trimester     testing.      Specific Aim 3: To test the hypothesis that 1,5-anhydroglucitol, a sensitive marker of     hyperglycemia, can be used as a simple and sensitive serum test for GDM in the obese     population.   "
108604|NCT01864473|"     Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an     ancient surgical problem. It was commonly described even in the Vedic period. The description     of Bhagandara, with the full text of its managements, can be gathered from the Sushruta     Samhita, which is supposed to have been written in the second century B.C. Fistula-in-ano is     a tubular ulcer formed around the peri-anal region. It may also be found anywhere in the     perineal region. Its ramifications can extend to the lower back, subscrotal region, vagina     etc.      Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment     due to probability of recurrence after surgery. The present treatment modality Kshar Sutra     has been found effective and as adjuvant therapy by avoiding recurrence.   "
108605|NCT01864460|"     Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired     glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting     glucose (IFG), and early diabetes affects a considerably larger but unknown population group.     At the current time there is no effective therapy to completely prevent, or reverse     neuropathy associated with IGR and this represents a considerable challenge in     rehabilitation. There is a particularly strong incentive to prevent IGT and related     complications from advancing to DM2. IGR is a growing problem among all older adults and its     strong association with many functional limitations, particularly mobility limitations, is     not always recognized, even though diabetes-related disability occurs in up to 2/3 of older     adults with diabetes and is associated with dependency, poor quality of life, and increased     acute and long-term care utilization.      Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data     shows that over 90% of subjects with IGT have an abnormal score on questionnaires about     autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet     that are colder than the rest of the body, decreased sweating in the feet or increased     sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation,     or leaking of urine. In addition, patients with IGR have impaired balance control. These     factors can increase the risk of falls in affected subjects. A non-randomized and     non-controlled study showed that a diet and exercise intervention in patients with diabetes     led to an overall improvement in autonomic function. Furthermore, it was shown that standing     balance can be improved with a balance intervention program.      However, there are no published studies that assess the effect of an intense physical     activity intervention on autonomic function in IGR related neuropathy. This study will test     an aerobic exercise and balance intervention in participants with IGR. The investigators will     examine if an individually tailored, carefully monitored, Diet, Physical Activity, and     Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when     compared to patients who receive standard care. Improving balance control and autonomic     function can decrease the risk of falls and have a significant effect on the health of     participants.      The research is also significant because it will test subjects either before they become     diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the     autonomic neuropathy or balance impairment. Furthermore, the study is designed to test     whether improvement in autonomic function and balance is associated with improvement in     clinical outcomes, quality of life, and the metabolic state of participants. Thus, the     proposed interventions are likely to have a real life impact on participants and their     health.   "
108606|NCT01864447|"     Patients after an acute blood clot in the veins are at risk for leg-related complications     such as pain, swelling, and immobility. In addition, the occurrence of blood clots can have     major implications for personal health including weight gain, blood clot recurrence and     impairment in cardiovascular functioning. The goal of this study is to determine whether     aerobic exercise training is a therapeutic strategy to offset risk factors for recurrent     blood clots or leg complications.   "
108607|NCT01864434|"     This study will compare the kinematics data collected from patients with implants created by     different manufacturers to see which of these implants provides a more normal-like kinematic     pattern compared to the normal knee.   "
108608|NCT01864421|"     This is an observational study to see if at birth, flow of blood from a placenta to the baby     can be estimated non-invasively using Doppler ultrasound and/or cutaneous perfusion measured     using a novel PPG sensor.   "
108609|NCT01864408|"     The primary aim is to assess whether an interactive patient/provider counseling process using     a web-based tool (iPadTM) will improve patient satisfaction regarding understanding of her     bulge symptoms.      The secondary aims are to assess whether an interactive patient/provider counseling process     using web-based tool (iPadTM) will:        1. Decrease patient anxiety with counseling        2. Improve patient satisfaction with counseling        3. Improve provider knowledge, anxiety, and satisfaction with counseling        4. Be easy to use in clinic        5. Be actually used in clinic   "
108610|NCT01864395|"     It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass     will result in improved patient outcomes over the 12-hour post-operative period as compared     to control and off-line MUFF.   "
108619|NCT01864278|"     The registry will enroll patients with claudication or ischemic rest pain and an     angiographically significant lesion in the superficial femoral or popliteal artery. Subjects     will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per     current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.   "
108620|NCT01864265|"     By using functional MRI the investigators have recently shown that TNFi elicit rapid changes     in brain function linked to the perception of RA [5]. Functional MRI represents a method     allowing detecting tiny changes in neuronal activity by measuring alterations of blood flow     in the context of neuronal activation. TNFi rapidly reversed the widespread activation of     brain centers involved in pain such as the thalamus and the somatosensoric cortex, as well as     those involved in the control, of mood and emotions such as the limbic system. Moreover, as     small phase I study with 10 patients with RA showed that high brain activity detected in the     functional MRI predicts clinical response to Certolizumab Pegol after 1 month, suggesting the     central nervous system activity may be used as a tool to predict response to TNFi [8]. The     rationale of this study is to test whether response to TNFi can be predicted by using     functional MRI.   "
108611|NCT01864382|"     The stroke as cerebrovascular disease is the leading cause of permanent neurological     disability and the third death in the Western world. Their affected often have motor and     sensory disturbances in the form of hemiparesis with a possible influence on the balance be     altered trunk muscles, important components of postural control. The treatment of stroke,     covers a wide range of different strategies and approaches physiotherapy, including, specific     exercises on the trunk called core stability, performed by the patient with the help and     supervision of a physiotherapist specializing in neurology, that are based on coordination,     motor and proprioceptive work, especially the lumbar-pelvic. The effectiveness of these last     years has been demonstrated empirically, but until now there is no sufficient evidence of the     effects of these exercises on sitting balance in respect, and standing up in the subacute     phase post-stroke patients. To prove the evidence raises a randomized, multicenter, blinded     and where the evaluator will not participate in the analysis and processing is done by     intention to treat. Patients will be divided into two groups: control (usual physiotherapy     center made ) and experimental (made also 15 minutes workout core stability). The     intervention will have a frequency of 5 days a week for 5 weeks and up to 12 weeks. The     expected effect is that the experimental group patients develop better postural control at     the trunk and this influences the balance in sitting, standing and walking.   "
108612|NCT01864369|"     Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission     within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling     by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for     medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the     rate of death and CHF hospitalization. In the absence of intervention, patient adherence to     these behaviors is below recommended standards and quality of life among CHF patients becomes     progressively compromised. A major challenge is to make self-care counseling available     without overtaxing health care resources.      This 3.5 year multicenter clinical trial will establish and evaluate a Canadian e-platform     that provides multidisciplinary e-counseling to help patients with CHF to initiate and     maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in     Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of     e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life,     self-care behaviors and heart health. This proposal is based upon previous clinical trials in     CHF, e-health and preventive lifestyle counseling by our team. It also builds upon our     established collaboration with the consumer eHealth program of the Heart and Stroke     Foundation of Ontario. The novel contribution of this research is that it will establish an     infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key     feature of this proposal is that our multidisciplinary team will work with the Heart and     Stroke Foundation to share our findings and e-health resources with the public and other     health care professionals in Canada, which will help to galvanize research and clinical work     in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve     the quality of life of patients with CHF.   "
108613|NCT01864356|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple     doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a     history of repeated IVF failures.   "
108614|NCT01864343|"     The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic     myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling     to temperatures below 35°C before revascularisation can additionally reduce infarct size and     therefore improves outcome in these patients.      The purpose of the study is to determine the feasibility and safety of a combined cooling     strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in     patients with acute st-elevation myocardial infarction.   "
108615|NCT01864330|"     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the     elderly population. Topically administered lubricants are the basis for treatment of this     disease. However, information about the corneal residence time of topical lubricants is still     sparse, therefore no ideal treatment regimen has been found.      Recently a new method for assessment of tear film thickness based on optical coherence     tomography (OCT) has become available. The aim of the present study is to assess corneal     residence time of three different formulations of topical lubricants, in particular Thealoz     Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye     disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease     index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be     performed..   "
108616|NCT01864317|"     Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular     pressure (IOP) has been identified as the most important risk factor. However, some patients     progress despite adequate IOP lowering while some subjects with elevated IOP never develop     glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal     range. Therefore, other factors must be involved. In the last years, studies using MRI have     been performed and evidence has accumulated that also changes in retrobulbar structures are     present, in particular in the lateral geniculate nucleus and the visual cortex. However,     these studies were limited by the low spatial resolution of the MRI instruments used.      The investigators propose to overcome this problem by using an ultrahigh-field Magnetom 7T     whole-body MR scanner (Siemens Medical, Germany) installed at the MR Centre of Excellence at     the Medical University of Vienna. This scanner is equipped with a 32-channel head coil and     the SC72 high-performance gradient system and is thus perfectly suited for structural and     functional imaging. The aim of the present study is to investigate whether structural and     functional parameters are altered in patients with primary open angle glaucoma (POAG), normal     tension glaucoma (NTG), ocular hypertension (OHT) compared to healthy control subjects. The     exact topographical survey of intracranial structures such as the LGN and the assessment of     neuronal structures by DTI may allow for the better assessment of therapeutic responses to     new neuroprotective agents.   "
108617|NCT01864304|"     Williams Syndrome (WS) is a genetic syndrome with features that may include vascular     stenoses, neuro-developmental changes, and a variety of endocrine and metabolic     abnormalities, including impaired glucose metabolism and abnormal body composition.     Approximately 75% of adults with WS have impaired glucose tolerance or diabetes on oral     glucose tolerance testing (OGTT). In addition, clinical observations and preliminary data     suggest increased overall body fat in these individuals, as well as a relative increase in     fat deposition in the lower extremities. However, glucose and lipid metabolism in WS remain     incompletely characterized. The purpose of the current study is to carefully describe glucose     metabolism and lipid parameters in people with WS.   "
108618|NCT01864291|"     The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI)     can improve hearing in children who are deaf and cannot receive a cochlear implants.   "
108625|NCT01864200|"     This study will evaluate the recovery from copperhead snake bite in patients with mild or     moderate venom effect. Potential subjects will receive CroFab antivenom or placebo. The trial     is conducted by emergency room doctors, toxicologists, or surgeons at hospitals in regions     where copperhead bites are common. After blinded treatment and discharge, the subject returns     to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake bite. The subject     will also be called by telephone for follow-up assessments on day 10, 17, and 24 after snake     bite. The purpose of this study is to compare recovery in copperhead snake bite patients     treated with antivenom versus placebo (no active drug) as measured by the Patient Specific     Functional Scale (PSFS) at Day 14 follow-up.   "
108626|NCT01864187|"     Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective,     potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects.     The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of     the drug in these people is still unknown.This research was designed to study the     pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.   "
108627|NCT01864174|"     The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2     diabetes is non-inferior to Metformin IR monotherapy   "
109323|NCT01855048|"     The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics     of single dose of N-Rephasin® SAL200 in healthy male subjects.   "
108628|NCT01864161|"     Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to     erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia     in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and     absorption, gastroenteric bleeding, urinary iron loss in patient with significant     proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the     prescription of iron is usually oral because of practicality and safety, but often it is     inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance     to oral administration, irregular intake. There're few randomized controlled studies about     the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them     demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin     levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption     and high bioavailability with lower incidence of side effects. The investigators study aims     to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron     in CKD anemic patients not on dialysis in the presence of iron deficiency.   "
108629|NCT01864148|"     The primary objective of the study is to evaluate the efficacy of BIIB033 in participants     with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.      Secondary objectives of this study in this study population are to assess the safety,     tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.   "
108630|NCT01864135|"     Prostate cancer has been the most common cancer in men in Finland over the last ten years.     Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer.     However, PSA has a limited sensitivity and specificity for prostate cancer detection.     Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)     guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed     instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there     is an increasing interest in developing more accurate non-invasive imaging modalities.      This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum     level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric     magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using surface coils will be     used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS     guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS     biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from     fresh biopsy sample will be collected and correlated with the presence or absence of prostate     cancer.   "
108631|NCT01864122|"     The overall objective of this research proposal is to determine whether the predictive value     of using plasma concentrations of selected nutrient biomarkers of food intake determined     using a single plasma sample either alone or in combination are stronger, objective     predictors of subsequent death from coronary heart disease (CHD) or myocardial infarct (MI)     compared to selected food intake data derived from subjective, self-reported food frequency     questionnaires.   "
108632|NCT01864109|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     irinotecan and temozolomide has on Ewing sarcoma.      Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat     pediatric patients at MSKCC. The investigators have used these two drugs for many years to     treat patients with Ewing sarcoma whose cancer has relapsed.      For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a     five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This     standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have     their cancer cured by the chemotherapy and surgery/radiation therapy.      This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard EFT     regimen. The investigators are trying to improve the success of standard therapy by adding     these drugs. The use of irinotecan and temozolomide in this study is experimental because     they have not been used before in patients with newly diagnosed Ewing sarcoma. However the     investigators have found these drugs to be effective in patients with relapsed Ewing sarcoma.     It is not known if adding these two drugs will improve the outcomes of patients treated for     Ewing sarcoma.   "
108633|NCT01864096|"     This study aims to see if metformin can delay the time to progression in men with low risk     prostate cancer when compared to a placebo.   "
108687|NCT01863394|"     The objective of this study is to determine the efficacity of a community strategy for     screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their     mothers' compared with a community screening strategy conducted by Community Health Workers.   "
108688|NCT01863381|"     This research is being done to determine the accuracy of two noninvasive methods of measuring     the pressure of the cerebrospinal fluid (CSF), also known as intracranial pressure or ICP.   "
108635|NCT01864070|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of everolimus with TheraSphere that can be given to patients with advanced NETs     that have spread to the liver. The safety of everolimus and TheraSphere will also be studied.      Everolimus is designed to block a protein inside the cancer cells, which is also involved in     cancer growth.      TheraSphere is a medical device containing a radioactive material called yttrium-90 (Y-90).     Tiny glass beads called microspheres are filled with Y-90 and then injected through an artery     directly into the liver. This allows a large dose of radiation to be given directly to the     tumor, which may lower the risk of side effects from the radiation to other parts of the body     and/or to healthy liver tissue. The radiation from TheraSphere stays in the body and begins     to lose its effect within 12 days. The glass microspheres will stay in the body from that     point on. The radiation will eventually decay (go away). By the time a participant leaves the     hospital, the amount of radiation outside of the body will be low enough to not be a threat     to others.   "
108636|NCT01864057|"     Thiamine deficiency causes beriberi and is common in parts of rural Cambodia, where it     appears to be a leading cause of infant death. The change in maternal and infant thiamine     level after administration of thiamine to either Cambodian mothers or their infants is     unknown. Normal human breast milk thiamine levels in thiamine-replete mothers are poorly     characterized. The aim of this study is to determine if thiamine administered to nursing     Cambodian mothers normalizes maternal and infant thiamine levels. Levels will also be     obtained in nursing Caucasian mothers residing in the United States.   "
108639|NCT01864018|"     This phase I/II trial studies the side effects and the best dose of cyclophosphamide when     given together with ixazomib citrate and dexamethasone in treating patients with previously     untreated symptomatic multiple myeloma or light chain amyloidosis. Drugs used in     chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Ixazomib citrate may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with     ixazomib citrate and dexamethasone may be a better treatment for multiple myeloma or light     chain amyloidosis.   "
108640|NCT01864005|"     The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect     of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.   "
108641|NCT01863992|"     The investigators wish to learn about the quality of life (QOL) of children needing long term     home ventilation and also that of their regular caregivers. In addition, the investigators     will monitor the extra health-related expenses these families must meet. Data will be     collected using two age-specific questionnaires of QOL plus a third one validated for     assessing chronic health care costs. Questionnaires will be administered at an initial face     to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses,     one and two months later.   "
108642|NCT01863979|"     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and its prevalence     increases with aging of the population. It is reflected in the ECG recording by the     replacement of regular P-waves by an undulating baseline and irregular ventricular complexes     [2]. The uncoordinated atrial activity prevents effective atrial contraction, leading to clot     formation. Atrial fibrillation contributes significantly to population morbidity and     mortality, and presently available therapeutic approaches have major limitations, including     limited efficacy and potentially serious side effects. It can be classified into one of the     three following categories:        1. Paroxysmal: self-termination within 7 days        2. Persistent: requires termination by pharmacological or direct-current electric          cardioversion        3. Permanent: restoration to sinus rhythm is impossible or inadvisable      It is believed that in many cases the natural history of AF involves evolution from     paroxysmal to persistent to permanent forms through the influence of atrial remodeling caused     by the arrhythmia itself and/or progression of underlying heart disease. As many underlying     conditions contribute to the development and progression of AF, the full and exact mechanisms     standing behind this common arrhythmia are not completely or sufficiently understood.      Thromboembolism is by far the most important complication of AF, and the most common factor     in stroke in the elderly. The determinants of Virchow triad, including stasis, endothelial     damage, and coagulation properties, are centrally involved in AF- related thrombus formation.      Hence, thorough searching for new possible causes or contributing factors for the developing     and progression of AF and its most threatening complication, thromboembolism, is mandatory      The aim of the study is to look for new possible causes of atrial fibrillation and its     complications.   "
108643|NCT01863966|"     From clinical observation that some achalasia patients drink water to help swallow food, the     investigators have proposed a systemic hot water drinking therapy. This study is to observe     its efficacy on achalasia symptoms and explore its mechanism.   "
108644|NCT01863953|"     This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared     with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.   "
108655|NCT01863810|"     Diabetic neuropathy is known to be the most common complication of diabetes, although the     estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is     accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life     and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to     manage the chronic neuropathic pain in diabetic patients. This study is designed as a     randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction     measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th     week of intervention is inferior to that of Lyrica.   "
108656|NCT01863797|"     The purpose of the study was to compare early induction versus expectant management regarding     outcome and experience of delivery in nulliparous women with a prolonged latent phase.   "
108657|NCT01863784|"     The purpose of this study is to characterize the pharmacokinetics (what the body does to the     study medication) of JNJ-38518168 at approximately steady-state (stable medication levels)     after administration of multiple oral 30 mg doses of JNJ-38518168 to participants with mild     or moderate hepatic (liver) impairment (abnormal function) compared with participants with     normal hepatic function.   "
108645|NCT01863940|"     Ukraine is a newly sovereign country in Eastern Europe with a large burn population. With the     collapse of the Soviet Union, burn programs have become decentralized and resources for     maintaining facilities have dwindled. Patients frequently present with debilitating burn     injuries and often do not receive necessary treatment secondary to limited resources and cost     of treatment.      The investigators have established an annual medical mission, outreach clinic and     telemedicine relationship with hospitals and burn centers in Ukraine in an effort to improve     burn care. One focus is post-operative pain control. The investigators have noticed a pattern     of anxiety with children from the Ukraine surrounding dressing changes which they believe     this is secondary to inadequate pain control in the immediate post-operative period including     the initial dressing changes.      The goal is to provide wound catheters with a continuous infusion of procaine in an attempt     to reduce the pain experienced in the early post-operative period and specifically with     dressing changes.      There will be 200 participants, 12-65 years old who are receiving reconstructive plastic     procedure with split-thickness skin grafts from lateral thigh in the study. 100 will receive     the standard pain management Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM regimen and     100 will receive wound catheters with continuous procaine infusion for 48 hours with the     standard Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM available for breakthrough pain.     Pain scores will be assessed prior to dressing change, during dressing changes and at 30     minutes and 1 hour after dressing change.   "
108646|NCT01863927|"     The purpose of this preliminary experiment is to measure the effect of a novel ventilation     system on the physiological strain during exercise in high heat load while wearing ballistic     protective vest. Ten young and healthy participants will participate in the study. They will     all go through a six days heat acclimation period in a heat chamber according to a valid     protocol. Afterwards they will be randomly exposed to 4 conditions during four separate     consecutive days.   "
108763|NCT01862393|"     This study aims to examine the variation in muscle torque and discomfort produced when     electrically stimulating quadriceps femoris using pulsed current with three different phase     durations in order to establish whether there are any advantages or disadvantages in varying     the phase duration over the range examined.   "
108647|NCT01863914|"     Background Arteriovenous (AV) fistula is the most common vascular access for long-term     hemodialysis in the end-stage renal disease (ESRD) patients. About 25% of these patients are     diabetes mellitus. However, the effects of hyperglycemia on the vascular function of     arteriovenous fistula are still remained unclear. Studies have shown that blood flow in the     AV fistula is significantly reduced in patients with diabetes mellitus. Diabetic patients     also require a longer period of time for the maturation of AV fistula, and have slightly     higher complication rate than non-diabetic patients. Statins have been widely shown to     mediate several important pleiotropic effects in the improvement of vascular endothelial     dysfunction, attenuation of inflammatory responses, stabilization of atherosclerotic plaques,     inhibition of vascular smooth muscle proliferation, and modulation of procoagulant activity     and platelet function.Our experimental studies in diabetic animals demonstrate that     administration of a water-soluble statin rosuvastatin significantly improves the fistula     flow, vascular function and luminal dilatation of AV fistula in diabetic rats by suppression     of vascular oxidative stress and inflammatory load.      Study hypothesis The central hypothesis of this research project is rosuvastatin mediates     pleiotropic protective effect on vascular endothelial function and suppresses the regional     pro-inflammatory reaction in the vasculature, therefore administration of rosuvastatin during     the perioperative period of creation of native AV fistulas in diabetic patients with ESRD may     potentiate the vascular function and reduce the primary failure rate of AV fistulae.   "
108648|NCT01863901|"     A proof of concept study to evaluate the feasibility of safe and effective treatment of upper     limb spasticity using the Cryo-Touch III Device.   "
108649|NCT01863888|"     Primary Objective:      To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing     forms of multiple sclerosis as compared with baseline values and those of a reference     population of untreated healthy subjects.      Secondary Objectives:      To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the     effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation     and cytokine production in situ).      To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis     (RMS) patients during a 24-week treatment versus baseline and healthy controls.      To assess the reversibility of all parameter changes in patients who discontinue treatment     after accelerated elimination procedure with cholestyramine or activated charcoal.   "
108650|NCT01863875|"     Treatment with cochlear implantation is now offered to proximately 95 % of children with     deafness in Norway. More than 500 children have been operated at Oslo University Hospital.     The study is a cross-sectional study aimed to investigate speech perception, language skills,     quality of life in all childhood cochlear implant (CI) recipients in Norway from 1988-2012.     Factors such as child characteristics, characteristics with the family, the cochlear implant,     the rehabilitation situation, choice of communication mode, school and work situation are     surveyed to see if these factors can be associated with variations in outcome. The study will     include pre and post lingual deaf children and children with multiple disabilities.     Participants are recruited and examined in conjunction with their annual CI control at the     hospital. It will be conducted a series of tests determining listening, speech and language     development, non-verbal intelligence. Questionnaires are used to collect background     information and quality of life experience. The questionnaires include self-report forms for     different age groups, and a parent report form. The patient will be tested for the most     common genetic causes of deafness. Additional data will be collected from patient records and     from local health register at Oslo University Hospital.   "
108651|NCT01863862|"     In elderly patients postoperative mortality measured 3-6 months after total mesorectal     excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly     patients even if a risk of local recurrence is slightly higher compared to the open surgery.     The investigators addressed the question whether watch and wait policy is safe in clinical     complete responders after (chemo)radiation for elderly patients with small or moderately     advanced tumours.   "
108652|NCT01863849|"     To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for     injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of     seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination     inhibition (HI) test.   "
108653|NCT01863836|"     The purpose of this study is to determine whether the use of fluoroscopy improves the     diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial     ultrasound (with the use of a guide sheath).   "
108662|NCT01863719|"     Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is     administered intramuscularly, intravenously (IV) or via inhalation. In the case of pneumonia,     aerosolized route of administration is favorable as it presumably delivers a high     concentration of drug directly to the infection site. Colistimethate sodium is an FDA     approved drug, however, its aerosolized use represents a new method of administration not     currently FDA-approved in the United States. In this proposal, the inactive prodrug     colistimethate sodium has been selected to use for aerosolization as it is better tolerated     than colistin sulphate. It is a randomized, open-labeled Phase 1 trial of aerosolized and/or     IV formulations of colistin as multiple doses over seven days. The primary objective of this     trial is to evaluate the safety and tolerability of multiple doses of aerosolized and     intravenous colistimethate sodium separately or in combination in healthy adult subjects.   "
108663|NCT01863706|"     Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin     is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative     treatment when Oxytocin isn't available. The aim of this study is to compare the safety and     efficacy of Oxytocin and misoprostol for prevention of PPH.   "
108664|NCT01863693|"     This multicenter, prospective, observational study will evaluate the safety and efficacy of     Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients     with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine     clinical practice. Eligible patients will be followed for approximately 15 months.   "
109069|NCT01858363|"     This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety     and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA)     balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic     or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.   "
108666|NCT01863667|"     This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the     sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin     intolerant or who have a contraindication to the use of metformin. The primary hypothesis is     that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants     treated with omarigliptin is non-inferior compared with that in participants treated with     glimepiride.   "
108667|NCT01863654|"     The objective of this study was to confirm if two formulations of montelukast tablets are     bioequivalent.      Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product     Singulair (5 mg chewable tablets; Merck Sharp & Dohme). The single dosage was one tablet.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 32 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
108668|NCT01863641|"     The purpose of this study is to determine whether calcitriol is effective in the treatment of     lupus nephritis.   "
108669|NCT01863628|"     Background and study hypothesis:      Many studies including prospective studies have been demonstrated that a long symptomatic     prodromal phase exists prior to the onset of full-brown bipolar disorder, lasting for 9-12     years (Egeland et al., 2000). During the prodromal stage, there are three main clusters of     syndromes, including hypomania/mania symptoms, depressive symptoms, and signs of attention     deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al.,     2008). Of the hypomania/mania symptoms, decreased sleep, elevated mood, irritability, mood     lability, increased energy, and psychomotor agitation are present most frequently. The     prodromal depressive symptoms are reported to be depressed mood, anhedonia, insomnia,     feelings of worthlessness. Among patients with bipolar disorders, 22.5% reported to comorbid     with pediatric ADHD. In addition, some symptoms are considered as non-specific such as     decreased functioning, anger outburst, social isolation, and anxiety (Egeland et al., 2000).      Offspring of parents with bipolar disorders are much likely to present prodromal symptoms     compared to offspring of healthy parents. In a 10-year longitudinal study using 55 prodromal     symptoms checklist, , Egeland et al.(2002) found that 38% offspring of parents with bipolar     disorder were considered as at risk compared to 17% in children of healthy parents. In a     15-year follow-up study, Duffy et al.,(2009) found that 32.7% offspring (aged 8-25 years old)     of parents with bipolar disorder met the criteria of major mood episode.      Objectives:      One primary objective of this study is to prospectively identify the prodromal stage of     bipolar disorder.      Another primary objective is to conduct a randomized, place-controlled trial of aerobic     exercise on people who suffering from prodromal symptoms to the extent of significantly     impaired function, with attempt at delaying or preventing the onset of a full-blown bipolar     disorder.      Design of study and the procedures:      The study will consist of two phases: one-week screening period and a randomized,     placebo-controlled, 3-month trial. During the screening period, offspring of parents with     bipolar disorder will undergo systematically clinical evaluations. The offspring will be     evaluated with clinical symptoms assessing scales, neuropsychological tests, magnetic     resonance imaging. During the 3-month trial period, the offspring who meet the inclusion     criteria will be randomly assigned to receive treatment of aerobic exercise, placebo, or     wait-list group. Psychiatrists are scheduled to assess mood, treatment outcome during the     3-month trial.      Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder     aged between 10—25 years, meeting the inclusion of prodromal stage, will be included in the     study. All of the offspring will undertake the Kiddie Sads Present and Lifetime Version     (K-SADS-PL), and a 70 checklist items of potential prodromal symptoms suggest by us as well     as by Dr. Correll et al. (2007). The parents of these offspring are to have a DSM-IV     (Diagnostic and Statistical Manual of Mental Disorders)-defined bipolar disorder (bipolar I     or II), confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis     I Disorders patient edition (SCID-I/P) [First et al., 2002]. The offspring are to be     recruited through the referrals by their parents who will receive psychiatric services in the     Guangzhou psychiatric Hospital.      The offspring will be randomly assigned to aerobic exercise and placebo controlled groups.     The aerobic exercise would include cycling, jogging,table tennis, and playing badminton for     40 mins at least 3 times a week for 3 months. In each exercise, participants are supposed to     exercise to the extent of getting sweaty. In the placebo group, participants will receive     general psychoeducation, including delivering knowledge on symptoms, discussion of the     suffering mental difficulties, and general coping techniques.      Significance:      Bipolar disorder is a common, chronic, and recurrent mental disorder. The recognition of     prodromal stage of bipolar disorder and the early intervention on it may help delay or     prevent the onset of bipolar disorder.   "
108670|NCT01863615|"     The objective of this study was to confirm if two formulations of isotretionin (capsules) are     bioequivalent.      Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product     Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single     dosage.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fed conditions.      The population was composed of 36 healthy volunteers, male adults between 18-45 years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
108671|NCT01863602|"     The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of     lamotrigine tablets to collect safety information in the long-term use according to seizure     type and concomitant antiepileptic drug (AED), and to confirm its efficacy.   "
108672|NCT01863589|"     This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among     subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir     tablets.   "
108673|NCT01863576|"     The objective of this trial is to study the effects of omega-3 PUFA supplementation on the     inflammatory response and lipid profile in patients with chronic Chagas cardiomyopathy.      Study Type: Interventional      Study Design: A total 40 patients will be randomly assigned into two parallel groups. The     intervention will be treatment with omega-3 PUFAs at a dose of 3 g/day for 8 weeks, compared     to placebo (corn oil). The primary endpoints will be the concentrations of inflammatory     markers (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Secondary endpoints     will be the fasting glucose, lipid, and anthropometric profiles.   "
108674|NCT01863563|"     Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of     QuickClot.   "
108675|NCT01863550|"     This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see     how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating     patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer     cells   "
108676|NCT01863537|"     This RCT will randomly assign 40 of the CBOs to receive the Multimedia intervention and     training package (Multimedia)and the other 40 to receive the original, manualized Connect     intervention and training package (Traditional). The technology transfer process involves all     agencies receiving four days of training and two planned technical assistance conference     calls, by study investigative staff, in the first four months following training. Telephone     assessments completed by up to 6 staff at each agency will measure primary outcomes,     mediating, moderating and process measure variables at baseline, 6, 12 and 18 months     post-technology transfer. The primary outcome of the study is adoptions of the Connect     intervention. The unit of analysis is the CBO.   "
108677|NCT01863524|"     The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%.     when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in     women.      As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients     with acute coronary syndrome represent a high risk population in which screening for another     atherosclerotic site is recommended.      Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the     opportunity to evaluate the cardiac morphology and function and to screen for Abdominal     Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique     was between 91-96% for AAA screening.      In addition, this method is cheap, available and requires only 2-3 minutes to be added to the     standard TTE.      we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA by     TTE in subcostal views in addition to the standard TTE examination.   "
108678|NCT01863511|"     For patients hospitalized with acute decompensated heart failure,volume removal remains the     primary therapeutic objective. The current standard of care remains loop diuretics.The high     likelihood of readmissions and poor outcomes highlights the need to examine and improve     in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal,     less neurohormonal stimulation and greater sodium removal.However it is associated with     increased costs, line complications, and relative immobility during treatment. Tolvaptan in     addition to diuretic therapy has been shown to improve the amount of volume removed compared     to diuretic alone.      The study proposes to compare the strategy of adding tolvaptan to usual care with     ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients.      Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:        -  greater volume and weight reduction compared with usual care        -  similar efficacy outcomes compared with ultrafiltration, with less complications of          therapy   "
108679|NCT01863498|"     Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000     children. Operative repair of the anterior thoracic concavity has transitioned to the     minimally invasive approach with substernal bar placement through small axillary incisions     (Nuss procedure and multiple modifications). These procedures were quickly incorporated by     high volume centers around the world including our own. The operation is certainly quicker     and associated with less blood loss than the open operation, but as opposed to most minimally     invasive versions of an operation, patients do not leave the hospital sooner after bar     placement and experience more post-operative pain.      Pain during the post-operative hospital stay is the dominant management issue after bar     placement. The sparse literature on the topic has suggested that a thoracic epidural is the     most effective means for attenuating the pain during the first few post-operative days.     Therefore, most centers approach all patients undergoing a pectus deformity repair with an     attempt at epidural placement under the assumption that this provides the most effective     strategy for pain control.      However, the investigators conducted a retrospective evaluation to examine the validity of     this assumption and to investigate whether there is a role for a prospective study to     determine the optimum post-operative pain management of these patients. The results     demonstrate there was a decreased length of stay in the patients not treated with an epidural     (PCA), despite no disadvantage in pain control. Further, 30% in whom an epidural was     attempted, catheter placement failed.      This data certainly challenges the assumption that an epidural is the optimum management for     these patients, and convincingly answers the question as to whether there is a role for a     prospective randomized trial.   "
108680|NCT01863485|"     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and     Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.   "
108681|NCT01863472|"     Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the     endoscopic ablation system in comparison to irrigated radiofrequency current ablation in     patients with drug-refractory persistent atrial fibrillation.   "
108682|NCT01863459|"     1. To evaluate the safety, and efficacy of Lisdexamfetamine dimesylate in the treatment of          outpatients with DSM-IV ADHD with anxiety and depressive disorder comorbidity, as well          as to evaluate the effects on quality of life .        2. To evaluate the efficacy of Lisdexamfetamine dimesylate in the treatment of anxiety and          depressive disorders which commonly occur with ADHD.        3. To examine the potential relationship between telomere length and Adult ADHD with          comorbidity and the potential effect of treatment response.        4. To examine the potential associations with specific genes and Adult ADHD.   "
108683|NCT01863446|"     Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin     secretion and reduce uterine contractions in women at late term pregnancies.      Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported     uterine contractions in women at late term pregnancies.   "
108684|NCT01863433|"     This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,     inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in     healthy adult volunteers aged between 18 and 60 years.   "
108685|NCT01863420|"     Concurrent chemotherapy with external beam radiotherapy is the standard treatment of bulky or     locally advanced cervical cancer, gastric cancer and rectal cancer.Despite excellent     therapeutic results, acute hematologic toxicity (HT) is common with this regimen. Previous     studies have founded acute HT was significantly associated the volume of pelvic (PBM) and     lumbosacral bone marrow (LSBM) receiving 10 and 20 Gy radiation (RT). Therefore, reducing the     volume of BM receiving low-dose RT might prevent HT.      More than one-half of the body's bone marrow (BM) is located in the PBM, LSBM and proximal,     where is just in the low dose of RT in patients with gastric, rectal and cervical cancer.     Previous study have demonstrated highly conformal IMRT treatment plans reduced the volume of     PBM irradiated resulting in less HT. We have since assumed that even better BM sparing is     possible when the BM is entered as a separate constraint in the planning process. However, it     is well known that hematopoietically active (red) BM is poorly visualized with computed     tomography (CT). Consequently, the entire contents of the medullary canals must be entered as     BM. Yet, a considerable portion of the medullary canal is comprised of inactive (yellow)     marrow, which is composed primarily of fat. Contouring the entire medullary canals on CT thus     overestimates the volume of active BM, unnecessarily constraining the IMRT plan. An     alternative approach is the incorporation of functional BM imaging into the treatment     planning process. One economical and efficiency approach involves the use of T1-weighted     magnetic resonance (MR) images.      Therefore, we designed this study to test whether a separate constraint of active BM     identified by MR could reduce acute HT in course of concurrent chemoradiotherapy for patients     with gastric and rectal cancer.   "
108686|NCT01863407|"     This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole     (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal     operation when compared with a placebo.   "
108690|NCT01863355|"     Fentanyl based intravenous patient controlled analgesia(PCA)is popular method for     postoperative pain control, but information regarding optimal dose of fentanyl in IV PCA is     currently lacking. We thus determine appropriate dose of fentanyl (bolus dose and background     infusion rate) for effective pain control with minimal side effects such as nausea and     vomiting   "
108691|NCT01863342|"     Nociceptor inputs can trigger a prolonged but reversible increase in the excitability and     synaptic efficacy of neurons in central nociceptive pathways, the phenomenon of central     sensitization. The degenerative joint disease, osteoarthritis, with characteristic     destruction of cartilage and alteration in bone is a very common cause of chronic pain. The     degree of pain does not always correlate with the extent of joint damage or presence of     active inflammation raising the possibility that there may be a central component to the     pain. The central sensitization inventory (CSI) is a new self-report screening instrument to     measure the degree of central sensitization, and to help identify patients with central     sensitivity syndromes. The aim of this investigation is to evaluate the influence of     preoperative central sensitization, which represented by CSI score, on postoperative pain     score in osteoarthritis patients undergoing total knee replacement who receiving     patient-controlled epidural analgesia.   "
108692|NCT01863329|"     Studies in patients with intracranial hypertension have shown a good relationship between     optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured     intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath     diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.   "
109090|NCT01858090|"     In this prospective, randomized, double-blind, controlled study, the aim was to compare the     effect of adding fentanyl (10 µg) or sufentanil (2.5 µg) to levobupivacaine (2.2±0.2 ml 0.5%)     on the intraoperative anesthesia quality, block characteristics, the side effects on the     newborn and mother, the duration of postoperative analgesia, and surgeon satisfaction score.   "
108693|NCT01863316|"     Although the safety and efficacy of the I gel in children has been shown in several large     observational studies, There is no study about comparison of the clinical efficacy between     I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are     new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a     noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising,     showing an easy insertion, high airway leak pressures, and low complication rates with few     postoperative complaints. The aim of this study is to compare clinical performance of the     pediatric i-gel and LMA Supreme in infants.   "
108694|NCT01863303|"     The incidence risk of colorectal cancer （CRC） is increasing at 4.2% year by year in China.     Most effective way to reduce the death rate of CRC patients is to diagnose in quite an early     stage. QiaoKou District is a chemical industry Zone of Wuhan with a long history, which has     few data of CRC epidemiology. The investigators design the primary CRC screening for this     district by healthy questionnaire, Fecal Occult Blood Test(FOBT) and colonoscopy. HanYang     Areo has been chosen as Control for its non-industry environment.The crowd would be screen     biennially. The high risk group would be intervened, such as resection of polyps or other     specific treatment. A follow-up registration database has been built for analysis the     relationship between incidence or death rate to high risk factors, such as age, life     environment, lifestyles, base diseases and family history of cancer.      This study will provide some epidemiology dates of CRC to the local Government, and assist     the governor to built a more effective screening system of CRC.   "
108695|NCT01863290|"     The Transitions Clinic Network (TCN)aims to connect former inmates to primary care using     trained, culturally competent primary care providers and community health workers (CHWs). The     purpose of this project is to support ongoing quality improvement at the 13 participating     sites by training culturally competent CHWs and measuring the health, health care     utilization, and the costs of caring for former inmates.   "
108696|NCT01863277|"     The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily)     for a better clinical outcome in the period three days post stroke.   "
108697|NCT01863264|"     The purpose of this study is to see if cold liquids improve the swallowing mechanisms in     premature infants with swallowing difficulties (dysphagia). The only way to objectively     diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study     (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants     suspected of having dysphagia and who are referred for a VFSS will be recruited for this     study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed     with dysphagia, the study protocol will begin by keeping the infant the same position and     feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be     visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows     and the study swallows will be recorded for analysis and comparison. It is hypothesized that     the study swallows will have less deficits than the standard swallows. If an infant's     standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this     study.   "
108698|NCT01863251|"     To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4     months of atomoxetine treatment for patients with co-occurring ATS and heroin dependence     (COATS) receiving buprenorphine maintenance treatment (BMT) and educational drug and HIV risk     reduction counseling (EDRC).   "
108699|NCT01863238|"     This study is designed to evaluate the risk of cataracts (lens opacities) and describe the     best corrected distance vision (with glasses/contacts for those who wear them) of pediatric     patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor     treatment initiation and are receiving or planning to receive commercially-available     ivacaftor in the US.   "
108700|NCT01863225|"     This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and     atorvastatin and rosuvastatin when either statin is administered in combination with     RVX000222 in subjects with dyslipidemia.   "
108701|NCT01863212|"     In order to investigate if individuals, carrying genetic variants predisposing to obesity,     respond differently to visual presented food images than non-carriers the investigators aim     to screen 500 people for a common risk variant in the FTO gene. From those 500 screened 40     subjects, 20 homozygous for the risk allele and 20 homozygous for a non risk allele will be     selected for the second step in the study. This part involves the fMRI technique to visualize     the brain response, focus on reward system activation, when food images are visually     presented in the scanner. Factors regarding eating behavior, sleep, physical exercise and     relation to food are investigated in the first part of the study as well as clinical     parameters such as BMI.   "
108702|NCT01863199|"     A study to use in home technology to reduce the burden of in office visits and injections.   "
108703|NCT01863186|"     The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride,     an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from     short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind     treatment portion where subjects will be randomly assigned to one of three doses of study     medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of lofexidine, or     placebo) followed by an optional open-label treatment period where subjects will be inpatient     or outpatient and receive lofexidine at variable dosing for up to an additional 7 days. The     Investigator hypothesizes that subjects will achieve maximum treatment effect with tolerable     side effects at the 3.2 mg total daily dose and that both the 3.2 mg and 2.4 total daily     doses will show better efficacy over placebo in treating symptoms of acute opioid withdrawal.   "
108704|NCT01863173|"     effect of B blocker was first evaluated in patient with cardiomyopathy not induced by     ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on     Thalassemia cardiomyopathy was evaluated in this study   "
108764|NCT01862380|"     The risk of adrenal insufficiency in patients with nonclassical congenital adrenal     hyperplasia due to 21-hydroxylase deficiency is not well documented. Indication of cortisol     replacement therapy in situation of acute stress or at long term is thus controversial. The     mineralocorticoid reserve of these patients has never been evaluated.      Hypothesis: The glucocorticoid and mineralocorticoid function of the adrenal glands in women     with nonclassical 21-hydroxylase deficiency is comparable with the adrenal functions of     healthy age- sexe- and BMI-matched subjects.   "
108705|NCT01863160|"     It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess     safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream,     administered topically up to 5 consecutive treatment days in healthy volunteers.      This is a single center trial. It is anticipated that the study will be conducted at the     Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.      The screening/enrollment visit includes a PK study for 24h following a single IP topical     application. After a 24h washout time break, the subject will enter the treatment period for     5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of     treatment.   "
108706|NCT01863147|"     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,     mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread     in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong     predictor of cardiovascular events and all-cause mortality .      Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular     mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .   "
108707|NCT01863134|"     1. INTRODUCTION           Through last couple of years the number of patients treated for acute coronary event          without persistent ST segment elevation in ECG has been growing.           This is probably an effect of improving diagnostics of myocardial infraction without          persistent ST segment elevation in ECG, due to routine Troponin serum level evaluation          and better primary prevention.           This fact makes the search for the optimal treatment for patients with acute coronary          event without persistent ST segment elevation in ECG, including both patients intended          for pharmacological and invasive treatment percutaneous coronary intervention (PCI) or          coronary artery byppass grafting (CABG).           Patients undergoing invasive treatment for acute coronary event, have higher risk rate,          than those with stabile angina pectoris.           The authors of this study want to evaluate, whether the proportional use of platelet GP          IIb/IIIa receptor antagonist - eptifibatide in patients undergoing CABG results in          improvement of short-, and long time results in those patients.           Eptifibatide ( Integrilin) a cyclic heptapeptide antagonist of the GP IIb/IIIa integrin          receptor, is an intravenous antagonist with rapid onset and short half-life.        2. STUDY RATIONALE      The notion acute coronary syndrome (ACS) includes several clinical situations, such a     unstable coronary artery disease, non-Q wave myocardial infarction and Q wave myocardial     infarction.      On the basis of 12-lead ECG, patients with acute coronary syndrome (ACS) can be divided into     two groups: with and without ST segment elevation.      Another stratification factor in patients with ACS, especially these without ST elevation is     evaluation of biochemical markers of myocardial necrosis, such as Troponins (TnI, TnT) and     creatinine kinase isoenzymes (CK-MB). Serum concentrations of these markers allow to     distinguish myocardial infarction (elevation of markers' concentration) from unstable     coronary artery disease.      All ACS have common etiopathogenesis which is plaque rupture, thrombus formation in the lumen     of coronary artery.      Platelets are the key factor in this process. Platelets by means of their collagen and von     Willebrand factor glycoprotein receptors bind to damaged artery wall. Simultaneously many     factors cause platelet activation, which leads to changes in their shape, release of     intraplatelet components and activation of fibrinogen-binding glycoprotein receptors IIb/IIIa     (GP IIb/IIIa). Activated form of GP IIb/IIIa binds to GP IIb/IIIa of another platelet by     means of fibrinogen molecule. Fibrinogen molecules form stable bridges between platelets.     This process is referred to as aggregation, and leads to clot formation, which is further     stabilized by fibrine fibres.      In this way the intravascular thrombus is formed, which after totally occluding the arterial     lumen causes acute ischemia of the relevant region of myocardium and subsequently its     infarction.      The key role of GP IIa/IIIb in the process of platelet clot formation has important     therapeutic consequences. By now several specific (direct) and non-specific (indirect)     antagonists of GP IIb/IIIa have been developed.      There are indirect antagonists as acetylsalicylic acid, ticlopidine and clopidogrel and     direct antagonists as abciximab, tirofiban and eptifibatide Additionally also anticoagulants     (heparin, LMWH - low molecular weight heparin) have antiplatelet properties by inhibiting     thrombin production.      Clinical studies performed all over the world have proven the efficacy and safety of three     agents from the GP Iia/IIIb group: abciximab, tirofiban and eptifibatide.      In several big clinical studies (EPIC, EPILOG, EPISTENT, ESPRIT, CAPTURE, PURSUIT,     PRISM-PLUS, TACTICS-TIMI 18) the high efficacy of these drugs was showed in patients with ACS     without ST segment elevation undergoing mainly percutaneous transluminal coronary angiography     (PTCA) and stenting. The use of GP IIa/IIIb antagonists in this group of patients     significantly reduces the death and myocardial infarction (MI) rate during early as well as     late follow-up period. Moreover, last observations indicate, that the biggest benefit from     such therapeutic strategy is observed in high risk patients; those with diabetes, high     troponin levels and ECG changes.      During last years, there is an increase in frequency of ACS without ST segment elevation.     This is probably due to improved diagnostics of MI without ST elevation basing on routine     troponin evaluation, but also thanks to better primary prevention.      Therefore determining an optimal therapeutic strategy for patients with ACS without ST     segment elevation remains a crucial issue.      It concerns patients qualified to medical treatment as well as those qualified to invasive     procedures (PTCA or CABG).   "
108708|NCT01863121|"     The CTP score is one of the best proved severity score in predicting mortality in patients     with cirrhosis. Portal hypertension and variceal bleed are significant causes of morbidity     and mortality in patients with cirrhosis. The recently published CTPK score included variceal     variceal bleed status to the CTP score which improved the accuracy of CTP score in predicting     short term mortality. CTPK score needs prospective validation.   "
108709|NCT01863108|"     The primary objective of this study is to evaluate the safety and tolerability of multiple     sub-cutaneous injections of GeniusVac-Mel4, a dendritic cell-based cancer vaccine, in     patients with melanoma. The secondary objectives are to determine immune response and     clinical efficacy of such injections in patients with melanoma.   "
108710|NCT01863095|"     Currently, marijuana (MJ) is the most popular illicit drug, but there are few effective     interventions to help young adults (age 18 to 25 years) to reduce their MJ intake. In this     study, we will develop and initially test a smart phone app designed to promote     exercise/physical activity as a positive alternative to MJ use. The app will be tested in an     efficacy study in which MJ users are randomly to either receive personalized feedback about     MJ use + use the exercise app or personalized feedback only. The results will contribute to     knowledge about exercise/physical activity as a strategy for reducing young adults' MJ use     and problems.   "
108711|NCT01863082|"     patients with resistant hypertension will be submitted to an exercise protocol in a heated     pool for three months   "
108712|NCT01863069|"     The primary objective was to determine the tolerability of a new inhaled formulation of     interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and     compared with standard intramuscular (IM) AVONEX® when given as a single dose.      The additional objectives were:      To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon     beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when     given as a single dose, when given once per week for 4 weeks, and compared with standard IM     AVONEX® when given as a single dose.      To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon     beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose,     when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a     single dose.   "
108713|NCT01863056|"     The purpose of this study was to determine whether the installation of sit-stand work     stations could lead to decreased sedentary time and increased physical activity during the     workday among sedentary office workers.   "
108714|NCT01863043|"     The primary purpose of this study is to determine nutrition outcomes and risks to     gastrointestinal integrity and function of aspirating for routine gastric contents prior to     each feeding in very low birth weight premature infants.   "
108715|NCT01863030|"     The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh     in ventral and incisional repair procedures by evaluating the following:        1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh          for up to 12 months post surgery.        2. Perioperative, short-term and long-term procedural and/or device related complications.        3. Abdominal Wall Function and mobility.   "
108716|NCT01863017|"     The purpose of this study is to determine the effects of transcranial direct current     stimulation (tDCS) as it modifies hyperphagia in obese subjects, non-obese subjects, and     subjects with Prader-Willi syndrome (PWS).   "
108744|NCT01862653|"     Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops     returning from combat zones. A majority of these veterans will report difficulty maintaining     or initiating sleep. The purpose of this research will be to conduct a prospective,     randomized, wait list controlled, small scale feasibility study to examine if the use of an     auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation     Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis:     Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF     veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or     standard therapy alone.   "
108717|NCT01863004|"     Dysferlin is a protein with an important role in the repair of muscle surface membranes.     Mutations in dysferlin cause different forms of muscular dystrophies. Dysferlinopathies are     inherited in an autosomal recessive manner, and many patients with this disease harbor     mis-sense mutations in at least one of their two pathogenic DYSF alleles. These patients have     significantly reduced or absent dysferlin levels in skeletal muscle, suggesting that     dysferlin encoded by mis-sense alleles is rapidly degraded by the cell's quality-control     system. In a series of in-vitro experiments we showed that mis-sense mutated dysferlin can be     salvaged from degradation by proteasomal inhibition. This resulted in an increase of     functional dysferlin protein and a subsequent repair of plasma membranes of cultured     patient-derived muscle cells. In this proof-of-concept study we would like to test wether     proteasomal inhibition can salvage mis-sense mutated dysferlin in patients harboring certain     dysferlin mis-sense mutations.   "
108776|NCT01862224|"     The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis     (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with     active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of     JNJ-38518168 over one year.   "
108718|NCT01862991|"     This research study investigates the use of a drug, mifepristone, given before second     trimester abortion. Mifepristone is a medication that is approved for medical abortion during     the first trimester. It also has been used prior to abortion in the early seconds trimester     (14-16 weeks gestation) and for medication abortion in the second trimester (also called     induction abortion). This medication has effects on the uterus that may help dilate, or open,     the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical     dilation, or opening, is essential to both ease of completion of procedure and reducing     complications that can occur. These complications include laceration, or tearing, of the     cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the     uterus) and are not expected to be increased in the study. Dilation of the cervix is usually     achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb     the moisture of the vagina and slowly expand, opening the cervix. The standard method of     dilation is performed at the clinic and involves the placement of cervical dilators the day     before the procedure. This procedure can be uncomfortable. A prior study showed that     mifepristone reduces the number of osmotic dilators that need to be placed prior to the     procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct     to cervical dilation or used alone, without dilators, as method of cervical preparation with     the hopes of reducing barriers imposed by painful procedures and time in clinic and away from     work/home that the current approach involving dilators requires.   "
108719|NCT01862978|"     The goal of this study is to show the efficacy and safety of heparin and nadroparin in the     acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2     hours after onset of clinical signs. Overall administration of anticoagulant agents will test     72 hours.      Randomized patients will be divided into three groups. The first group of patients will     receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by     intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT.     After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic     dose.      Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose     as recommended.      The third group of patients are those who will receive placebo intravenously and 24 hours     after receiving nadroparin subcutaneously in the therapeutic dose.      All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.      For initiation of treatment will be assessed:        -  Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion          criteria        -  Sign the informed consent and patient randomization        -  Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic          coagulation        -  Women of childbearing age (pregnancy test)        -  History, clinical presentation, medical history, basic internal review of the status          (blood pressure, pulse, body temperature, etc.).        -  Initial CT examination of the brain        -  EKG        -  USG sections of extracranial carotid and vertebral arteries        -  special hematology factors      If a patient meets all the necessary criteria, he may be given the test substance. During the     first 24 hours will be monitored at regular intervals vital functions.      After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also     100 mg of aspirin per orally.      In the interval from 24 to 30 hours of starting treatment the patient will be made:        -  Control CT brain        -  EKG        -  Basic coagulation        -  Reduction to stop treatment for newly identified haemorrhage or severe and extensive          focal cerebral ischemia by CT scan        -  special hematology factors           72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation          using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel          Index.      Safety endpoints: mortality, adverse side effects, bleeding   "
108720|NCT01862965|"     In this study patients with moderate to severe chronic graft-versus-host disease will be     treated with a combination of prednisone and everolimus. Patients will be treated on the     study for a maximum of 12 months and followed up for another 12 months.      The primary hypothesis of this study is that the addition of everolimus to prednisone     increases response rates without increasing treatment related mortality or mortality due to     relapse of underlying disease.   "
108721|NCT01862952|"     Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke epilepsy     are not known. Subclinical epileptiform discharges could contribute to the neuronal damage     and influence functional outcome. Electro-encefalography (EEG) is the golden standard to     detect interictal, ictal and subclinical epileptic brain activity.      Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack     will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and     paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together     with the EEG results. The EEG results will be correlated with the occurence of epileptic     seizures and functional outcome and mortality in the acute phase and in the long-term. When     subclinical epileptic discharges are found on the EEG, patients will be asked to participate     in a second part of the study where they will be randomised into a treatment (with an     anti-epileptic drug) versus no-treatment group for a period of 6 months. Outcome parameters     will be the occurrence of epileptic seizures, mortality and functional outcome.      Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the     acute phase following stroke influences functional outcome.   "
108722|NCT01862939|"     This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.      Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized,     placebo-controlled, two-period sequential pharmacodynamic (PD) arm.   "
108745|NCT01862640|"     To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in subjects with     agitation associated with dementia of the Alzheimer's type.   "
108746|NCT01862627|"     Clinical features, optical coherence tomography findings and surgical outcome in eyes with     macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit     or high myopia were evaluated.   "
109023|NCT01858961|"     The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI     207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based     regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients,     including patients with compensated cirrhosis.   "
139821|NCT01454518|"     The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic     solution around the hip joint will provide effective pain control after hip arthroscopy.   "
108747|NCT01862614|"     Infiltration (injecting next to the tooth) injections are common in dentistry and a number of     studies have shown that articaine anesthetic, when injected next to a lower molar, is more     effective than a local anesthetic injection of lidocaine. However success rates have not been     as high as hoped for. No objective study has addressed the success rate of buffering     articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the     purpose of this prospective, randomized, double-blind, crossover study is to compare the     degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine     solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary     infiltration in the mandibular first molar. The investigators will also record the pain of     injection and postoperative pain.   "
108777|NCT01862211|"     The deficiency of alpha-1 antitrypsin (DA1AT) is a genetic disorder of variable clinical     expression, initially described in adults with pulmonary emphysema patients. In children, it     is the second cause of neonatal cholestasis after biliary atresia and is a common indication     for liver transplantation.      Several genotypes for SERPINA1 gene coding for alpha-1 anti-trypsin were identified. The main     ones are M / M, M / Z, M / S and Z / Z and each genotype is closely correlated with the     concentration of blood A1AT. The estimate for France suggests a prevalence of genotype     deficit Z / Z of the order of 1/6054, (9982 patients), which in 11% of cases, have liver     disease (prolonged neonatal jaundice). Half of them will move towards the development of     cirrhosis with portal hypertension, at worst liver transplantation.      Currently, we do not know what are the clinical and genetic factors that predispose a patient     A1AT deficiency develop liver damage. Recent studies have led us to think that polymorphisms     in the gene SERPINA1, as well as that of the alpha-mannosidase 1 endoplasmic reticulum (Erman     gene) could be a predictive marker of liver complications. Another possible candidate gene is     one of the importin beta (KPNB1), a protein involved in the elimination of misfolded     proteins. These data lead us to propose the study of genetic polymorphisms.      The main objective of the study is to compare the allele frequencies of these polymorphisms     between (i) a cohort of A1AT deficient patients and with hepatic symptoms (portal     hypertension and its complications, severe liver failure leading to transplant or not, or an     indication for liver transplantation) and (ii) a cohort of A1AT deficient patients without     signs of hepatic call. To build this last cohort, we will include in the genetic study the     family members of deficient patients, some of whom probably carrying a deficit genotype Z / Z     but without any associated clinical manifestations. This will allow us to facilitate the     establishment of genotype profiles / phenotype clearly identified, which then allow a more     appropriate care for children who may have such a development, we will strive to achieve a     haplotype interpretation of polymorphisms found.      This study will be conducted in association with the DEFI-ALPHA study to identify clinical     and biological prognostic factors such as age at diagnosis, the diagnostic mode, the results     of liver biopsy (when available), the clinical course, family history, the existence of IUGR     and long-term treatment.      The secondary objectives of the study are :        -  The measurement and interpretation of serum IL-8 in A1AT-deficient patients. Indeed, one          study showed a higher IL-8 in patients with ulcerative colitis compared with healthy          patients' serum. These considerations led us to hypothesize that IL-8 may be a marker of          liver disease in A1AT deficiency.        -  Preservation of blood samples for further study of other genes, which may be in the          future suspected to be associated with the occurrence of liver complications. To this          end, a DNA bank will be created. It will involve the children with a deficiency of          alpha-1 antitrypsin and their family of 1st and 2nd degree in civil law (parents and          siblings).      This study is a continuation of the cohort DEFI-ALPHA (descriptive study of a cohort of     children with DA1AT) and sought to identify the clinical and biological factors such as age     at diagnosis, diagnosis mode, the result sets of the liver biopsy (when available), clinical     course, family history, the presence of IUGR and long-term treatment.      The only criterion for not-inclusion is, according to the subject, the lack of consent of the     child and his parents, the lack of consent of the adult patient, or the lack of consent of     the witness. Demographic and clinical history data (for parents and brothers/sisters showing     no DA1AT) will be collected.      Currently, the cohort of patients with DA1AT is being set up in the framework of the Cohort     DEFI-ALPHA. This multicenter project is realized with the help of french pediatric     hepatology centers that regularly follow patients DA1AT. Today, over 100 patients DA1AT have     already been identified, and the collection of historical data has already begun on several     centers since September 2009. This study is therefore a continuation of this work.      Over a period of 30 months, the total number of potentially includable subjects is estimated     at about 400 in this study (100 patients and 300 related to the first degree such as parents,     brothers and sisters).      This study will be promoted by the Hospices Civils de Lyon. Authorization of the competent     authority and the ethical committee will be obtained as well as informed consent from     families before blood sampling.   "
108723|NCT01862926|"     Interstitial lung disease (ILD) is characterised by inflammation and scarring of the lung and     is the leading cause of death in patients with systemic sclerosis, and contributes     significantly to morbidity and mortality in many other connective tissue diseases (CTDs) such     as polymyositis/dermatomyositis and mixed connective tissue disease. When ILD is extensive     and/or progressive, immunosuppressive medication is often required to stabilize lung disease     and alleviate symptoms. Current standard care for CTD associated ILD is extrapolated from     studies performed in individuals with systemic sclerosis and comprises low dose     corticosteroids and intravenous cyclophosphamide followed by oral azathioprine. In some     individuals even this intensive immunosuppression is insufficient to prevent deterioration,     and in a significant minority of affected individuals this results in respiratory failure and     death. Rituximab has recently been reported as an effective 'rescue therapy' for stabilizing     and even improving ILD in this patient group. Based on observations gained from this     experience, the investigators believe that rituximab is a potential important alternative to     current best therapy for this patient group. This study has therefore been initiated to     evaluate the efficacy of rituximab (compared with standard therapy) in patients with     progressive CTD related ILD.   "
108724|NCT01862913|"     Background: Most adolescents suffering depression are treated in primary care clinics.     Cognitive-behavior therapy (CBT) is effective in the treatment of adolescent depression. The     availability of appropriately trained CBT therapist may be limited, especially in primary     care clinics. One way to increase the availability of CBT is to use computer-assisted CBT     (c-CBT). It can be effective in the treatment of adults, although the outcomes in adolescents     remain unclear.      Purpose: The purpose of this study is to determine whether a computer-assisted     cognitive-behavioral therapy is effective for the treatment of depression in adolescents     between 15 and 19 years of age in 4 primary care clinics in Santiago, Chile.      Study design: A two-arm single-blind (outcomes assessor) randomized controlled trial will be     carried out with 216 adolescents. The efficacy, the adherence, and acceptability of the     computerized-assisted cognitive behavioral therapy will be evaluated.   "
108725|NCT01862900|"     This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with     stereotactic body radiation in breast cancer patients that have liver or lung metastases and     have received systemic therapy and have progressive disease. The investigators hypothesize     that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor     immune system response. This amplified and directed immune response could result in     anti-tumor responses.   "
108726|NCT01862887|"     The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24     mg oral tablet on the QTc interval   "
108727|NCT01862874|"     A study to evaluate the efficacy, immunogenicity, and tolerability of V501 (quadrivalent     Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine,     GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501     reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection     compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or     18-related persistent infection, condyloma acuminata, penile/perianal/perineal     intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.   "
108728|NCT01862861|"     Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various     menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced     peri or post-menopausal women.   "
108729|NCT01862848|"     To evaluate the change in patient pain perception with the use of a topical compounded pain     cream regimen.   "
108730|NCT01862835|"     Repletion of testosterone (T) in older men drives Growth Hormone secretion after its     aromatization to estradiol (E2) by potentiating endogenous GH drive.   "
108731|NCT01862822|"     Urinary tract infection (UTI) is a frequently suspected cause of fever in young children,     justifying urine cultures. Sampling procedures are decisive for the reliability of UTI     diagnosis. Even though official guidelines recommend clean catch method, catheterization or     suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate     of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators     have noticed that the rate of contaminated urine cultures was lower when children were kept     in an upright position at the time of urine collection. The upright position could explain     this decrease, perineum being less in contact with urine. These results are borderline     significant, the investigators would like to confirm them with a specific study.   "
108732|NCT01862809|"     Background:      - Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They     contribute to human health in many ways, including digesting food and balancing hormones.     Testing samples from the mouth can show how microbiotas are related to health and disease.     However, the microbiota in a person's mouth differs depending on the methods of collection     and the part of the mouth that is tested. Understanding what can change the microbiota     (including mouth sites, and what a person eats or smokes) will give more information on how     to study oral microbiota and smoking-related cancers and other diseases.      Objectives:        -  To see how smoking affects the microbiotas in mouth and nose.        -  To determine which collection method for mouth specimens should be used for studying          microbiota.      Eligibility:        -  Individuals at least 18 years of age who have been using tobacco products regularly for          at least 5 years.        -  Individuals at least 18 years of age who have never smoked.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have a dental exam. They will provide a saliva sample. The dentist          will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and          teeth. The inside of the nose will also be swabbed.        -  Participants will also fill out a questionnaire. It will ask about their history of          smoking and consumption of alcohol, tea, and coffee. It will also ask about current          medications, including antibiotics.   "
108758|NCT01862458|"     The objective of this study is to scientifically evaluate a new substrate for fibrinolysis     compared to our standard tPA.      The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the     addition of DNAse.      The primary outcome variable between the two techniques will be length of hospitalization     after initiation of treatment.   "
140606|NCT01444105|"     Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT     procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.   "
108733|NCT01862796|"     Background:      - Sticking to a diet plan can be difficult, but is important for many different health     reasons. Some people seem to have a harder time following and sticking to a diet plan than     others. It is not clear whether people of different weights (lean or obese) might have     differences in the way they adhere to diet plans. Researchers want to study three different     groups of people based on their body mass index (BMI), which measures people based on their     weight and height. The study will place the participants on a 6-week diet and see how well     they follow the diet. The information from this study may help develop better weight-loss     plans and healthy diet ideas.      Objectives:        -  To understand what factors affect adherence to a diet plan.        -  To collect information for future studies that may improve people's ability to stick to          diets.      Eligibility:      - Individuals at least 18 years of age who are lean (BMI between 18.5 and 25) or obese (BMI     greater than 30).      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. They will have a full-body scan to measure fat and muscle.          They will also answer questions on eating behaviors, mood, and desire to change eating          patterns.        -  Participants will be separated into three groups. Each group will have a different diet.          The lean group will have a heart-healthy diet designed to maintain the same weight. One          of the obese groups will also have a heart-healthy diet designed to maintain the same          weight. The other obese group will have a heart-healthy weight loss diet. In all groups,          all food will be provided by the study doctors. Participants should not eat any food          other than that provided for the study.        -  Everyone will start with a 1-week food testing period to find the right number of          calories for each group. After this first week, participants will attend one diet          counseling session per week and will be contacted randomly once a week to check on the          foods they have had in the past 24 hours. Participants will complete daily food diaries          on paper as well as daily food records using a smart phone.        -  Participants will come to the clinic twice a week to pick up the diet food. On one of          those days, they will also have their counseling session.        -  The study will last for 6 weeks. At the final study visit, participants will repeat the          tests from the screening study.   "
108734|NCT01862783|"     Background:      - Malaria is a disease caused by a parasite that infects the blood. It affects millions of     people every year and frequently harms or kills pregnant woman and infants. Researchers are     looking for treatments that may help pregnant women in areas of the world where malaria is     common. To do so, they want to collect blood and other samples from pregnant women in     south-central Uganda. They will also collect samples from newborn babies if the mother agrees     to it.      Objectives:      - To collect biological material such as blood samples from pregnant women and newborns.      Eligibility:        -  Women between 14 and 45 years of age who are pregnant or are in labor.        -  Participants will be from the Kalisizio area of south-central Uganda.      Design:        -  Women who are pregnant will provide blood and urine samples.        -  Women who are in labor will allow researchers to collect samples from their baby after          the delivery. Samples will be taken of placenta tissue and umbilical cord blood. The          baby will also be weighed and measured. Researchers will look at the baby's physical          appearance and muscle strength.        -  Treatment will not be offered as part of this study.   "
108735|NCT01862770|"     Background:      - A health event can be a powerful motivator for abrupt behavior changes. For instance, many     people who smoke stop after having a heart attack or being diagnosed with cancer. A relative     s health event may have a similar effect. For instance, smokers may try to quit after     learning that a parent or sibling has lung cancer. Researchers want to study relatives of     people with lung cancer to see how the relative s diagnosis affects a person s willingness to     quit smoking or have genetic testing.      Objectives:      - To study the impact of a relative s lung cancer diagnosis on a person s approach to genetic     testing and smoking cessation services.      Eligibility:      - Current smokers between 18 and 55 years of age who are close blood relatives of people     being treated for lung cancer.      Design:        -  Participants will be recruited through telephone surveys. Participants will log on to a          password-protected website. The site has two educational sessions and three surveys to          complete.        -  Participants will also be offered free genetic testing. The test will see whether they          have a gene that can reduce the effectiveness of some cancer treatment drugs. Those who          agree to the test will collect a cheek swab sample at home and send the sample in for          testing. They will receive the test results through the website.        -  The surveys will ask about risk perceptions and emotional responses to the relative s          diagnosis. They will also ask about smoking history, motivation to quit, and reactions          to information about smoking and genetic risk.        -  All participants will be able to receive free smoking cessation services.        -  Six months after completing the surveys, participants will have a follow-up phone call.          The call will ask whether participants used the smoking cessation services.   "
108736|NCT01862757|"     Background:      - Some people who are obese may have decreased muscle strength. They may have greater muscle     mass shown in scans, but they show poor results in exercise tests. Poor muscle strength might     cause some of the difficulty with exercise performance. Researchers want to test muscle     strength in the arms and legs of overweight women. They will also see how insulin resistance     affects muscle strength in these women.      Objectives:        -  To test muscle strength in overweight women.        -  To see if insulin resistance affects muscle strength.      Eligibility:      - Women at least 18 years of age who are overweight (body mass index greater than 25 kg/m2).      Design:        -  Participants will be asked to fast before having an initial blood test to measure          glucose and insulin levels.        -  On a different day, they will have the strength testing. The first test will measure leg          muscle strength by testing the quadriceps and the hamstrings. The second test will          measure arm muscle strength by testing the biceps and triceps. The final test will          measure hand muscle (grip) strength.        -  All the tests should take about an hour.   "
108737|NCT01862744|"     Background:      - Parkinson's disease causes slow movements, stiffness, and tremor. It can get worse over     time, and in some cases can lead to dementia. Researchers are interested in how dementia     affects the brain in people with Parkinson's disease. They will study both people with     Parkinson s disease and healthy volunteers. They will give tests of thinking and memory, and     look at brain activity using imaging studies. This may provide more information on what parts     of the brain are not working well in people who have dementia related to Parkinson's disease.      Objectives:      - To use imaging studies to see what parts of the brain do not work well in people with     dementia caused by Parkinson's disease.      Eligibility:        -  Individuals at least 40 years of age who have Parkinson s disease.        -  Healthy volunteers at least 40 years of age.      Design:        -  Participants will be screened with a medical history and physical exam.        -  This study requires two outpatient visits over 2 days.        -  Participants will have tests of thinking, memory, and concentration. They will answer          questions and fill out questionnaires. The tests will also look at how quickly they can          move and handle small objects. The tests will take about 3 hours.        -  Participants will have magnetic resonance imaging to study the brain. Functional MRI          (fMRI) can show what parts of the brain are used when performing a task. Participants          will respond to images on a computer screen during fMRI.        -  Treatment will not be provided as part of this study.   "
108759|NCT01862445|"     This is a non interventional study to evaluate the efficacy and safety of Chlorambucil plus     Rituximab as firstline therapy in elderly and/or unfit patients affected by B-cell Chronic     Lymphocytic Leukemia (B-CLL).   "
109024|NCT01858948|"     The investigators will test the hypothesis that the adverse effects of second-generation     antipsychotics exposure and the beneficial effects of long-chain omega-3 (LCn-3) fatty acids     are mediated by opposing effects on the enzyme implicated in the metabolic syndrome and     obesity.   "
109025|NCT01858935|"     This study is to evaluate the safety, tolerability, and pharmacokinetics of ND-L02-s0201 in     normal, healthy, subjects   "
108738|NCT01862731|"     Background:      - Researchers are interested in how the muscles affect the movement of the knee cap. These     muscles may be related to different kinds of knee pain that are not caused by an injury or a     disease. Imaging studies such as magnetic resonance imaging (MRI) can be used to look at     these muscles. To study these muscles and how they move, researchers will use MRI to look at     healthy individuals and individuals with knee cap pain.      Objectives:      - To study how changes to the muscles around the knee can influence knee pain.      Eligibility:        -  Individuals between 18 to 55 years of age who have knee cap pain that cannot be          explained by a specific injury or disease.        -  Healthy volunteers between 18 and 55 years of age.      Design:        -  Participants will be screened with a physical exam and medical history.        -  This study requires two visits. Each visit will use standard MRI sequences to take          images of the knee in motion and at rest.        -  On the first visit, the MRI scan will look at the knee in its natural state.          Participants will move the knee up and down for 1 to 3 minutes at a time during the          scan.        -  On the second visit, a local anesthetic agent will be injected into the muscle of the          thigh. The anesthetic will block this muscle from generating force for 2 or 3 hours.          Participants will move the knee up and down for 1 to 3 minutes at a time during the MRI          scan.   "
108739|NCT01862718|"     Background:      Pilot study to assess feasibility for combining treatment modalities that should be     synergistic (radiation and thermal ablation).      Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard     treatments for focal neoplasms in the liver.      High volume or scattered locations of tumor burden results in inability to successfully use     this technology for a large proportion of patients with hepatic neoplasms.      Methods to enhance treatment volumes could be advantageous in potentially increasing the     indications for thermal ablation or the number of patients benefitting from local ablation.      Primary objective:      To determine the safety of combining 2 standard therapies (thermal ablation and external beam     radiation therapy) for liver neoplasms up to 10 cm diameter.      Eligibility:      Patients greater than 18 years of age with pathologically proven unresectable primary or     metastatic hepatic neoplasms      Patients whose extent of hepatic metastases represents approximately less than 60% of total     liver volume AND whose extrahepatic metastatic disease is determined to be minimal      ECOG performance status of less than or equal to 2 and a life expectancy of more than 3     months      Patients with a history of chemotherapy, radiation therapy, or biological therapy for at     least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must     not have an acute, critical illness      If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3     mg/dl and Child-Pugh Classification A, (Class B & C are excluded)      Design:      Patients will undergo external beam radiation as well as thermal ablation according to     standard operating procedures of the NCI and NIH CC.      Patients will be monitored using the standard imaging studies when clinically warranted.      Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is     deemed beneficial for the patient by the investigator.      The sample size will be 10 evaluable patients   "
108740|NCT01862705|"     Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in     the management of patients with neck pain. However the mechanisms for pain relief associated     with this intervention remain largely unexplained. Recent evidence suggests structures within     the brain may have a role in creating responses of pain relief. This study aims to use     functional magnetic resonance imaging (fMRI) to determine if there is a change in blood flow     to structures within the brain following TSM in patients with neck pain. All patients will     undergo fMRI while receiving painful stimuli directed to two separate sites, the cuticle of     the index finger and the great toe. Subjects will then receive either TSM or     sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful     stimuli. The primary outcome of interest is the shift in blood flow within the brain before     and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD)     technology. This study will be the first to examine this type of response to manual therapy     within the brain in patients with neck pain.   "
108741|NCT01862692|"     This innovative interactive Internet-based parent education intervention will help serve to     promote the social emotional development and communication skills of infants to decrease the     chances of child maltreatment in low-income, culturally diverse, families.   "
108742|NCT01862679|"     The most common forms of renal replacement therapy currently in use are high flux     haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar     to the patient, there are important differences in what happens to the blood as it travels     through the dialysis machine.      During HDF, the machine controls hydrostatic pressure across the dialyser to remove     additional water together with toxins from the blood and this fluid volume is continually     replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste     substances, especially larger molecules, from the blood than HF-HD which may be of benefit to     the patient in the medium to long term.Despite the theoretical advantages, trials have so far     been unable to find any significant difference in death rates or the development of health     problems among patients on HDF or HF-HD.      It is therefore important to examine other factors which may help doctors and patients to     decide which treatment to use. The investigators have designed a study which aims to answer     three main questions:        1. Does HDF make patients feel better?        2. Is blood pressure more stable on HDF in comparison with HF-HD?        3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?      The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of     either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the     patient knowing which treatment they are receiving. After two months the patients will switch     to the alternative form of dialysis for a further two months. During the study the     investigators will ask the patients how long it took them to recover from the preceding     session of dialysis, assess the frequency of symptomatic low blood pressure and also perform     blood tests at set intervals to measure specific blood parameters.   "
108743|NCT01862666|"     Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal     squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development     is mostly associated with chronic injury from gastroesophageal reflux. BE is widely     considered the leading risk factor for the development of esophageal adenocarcinoma (EAC).      Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to     ultrasound, however, instead of producing an image from the scattering of sound waves, it     utilizes optical scattering based on differences in tissue composition to form a     two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating     cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is     comparable to low-power microscopy.      The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade     intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and     in-vivo setting and correlate those images to standard histology of endoscopic mucosal     resection specimens as the gold standard.   "
108806|NCT01861821|"     The purpose of this study is to determine whether multiple ports improve the analgesic     efficacy of flexible catheters used for the provision of epidural analgesia during the entire     continuum of labor and delivery   "
108807|NCT01861808|"     The project is aimed to develop predictive indices of spinal cord injury severity through the     analysis of cerebrospinal fluid of patient collected during acute injury.   "
140607|NCT01444092|"     A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease   "
108750|NCT01862562|"     Elderly patients have poorer preoperative conditions than younger patients. Therefore,     minimally invasive surgery should be an effective treatment method for elderly patients. The     investigators conducted a randomized trial that compared laparoscopic surgery and     conventional open surgery in elderly patients who were 75 years old or over. The purpose of     the present study was to clarify the effect of laparoscopic surgery in elderly patients. In     our hypothesis of this trial, laparoscopic surgery is superior to conventional open surgery     in short-term results, and same outcome in long -term results. Therefore, laparoscopic     surgery would be recommended as standard procedure in an elderly colorectal patient.   "
108751|NCT01862549|"     This study examines feasibility and preliminary efficacy of Dialectical Behavior Therapy     adapted to children (DBT-C). DBT-C as compared to treatment-as-usual (TAU) is hypothesized to     have lower drop-out rate, and higher treatment attendance and satisfaction. Further, DBT-C as     compared to TAU will have significantly greater reduction in symptoms of Disruptive Mood     Dysregulation disorder, including verbal and behavioral outbursts and angry/irritable mood.   "
108752|NCT01862536|"     The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the     healthcare system is extraordinary. COPD is the fourth leading cause of death in the United     States, and some estimates attribute up to $33.2 billion in health care costs to     COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare     system parallels these findings. According to the VA HSR&D Health Economics Resource Center,     COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran     patient population, is responsible for >14,000 VA hospital admission annually, and increases     by $1,051/patient the total annual health care cost burden on the VA Healthcare system.     Importantly, COPD is associated with frequent emergency room visitation and/or     hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen     morbidity and mortality in patients with COPD. This study will examine the potential for     tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by     decreasing pulmonary hypertension. Results from this study are expected to define the     potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful, this     treatment option may improve quality of life and outcomes for the large number of Veterans     afflicted with PH due to COPD.   "
108753|NCT01862523|"     Capsaicin nasal spray is used in daily practice against IR without knowledge about the exact     mechanisms involved in this treatment. Therefore, this study aims to address this issue by     studying the functional (electrophysiologic) changes after specific stimulations in IR     patients and healthy controls before and after capsaicin/placebo treatment.   "
108754|NCT01862510|"     The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to     maintain a euthyroid state are at increased risk of having celiac disease. It also attempts     to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid     state in patients with hypothyroidism that should prompt serologic testing for celiac     disease.   "
108755|NCT01862497|"     The purpose of this study is 1) to determine what physiologic factors (extracellular fluid     overload or vasoconstriction) contribute more to increased blood pressure levels between     dialysis treatments in hemodialysis patients whose blood pressure increases and decreases     during hemodialysis and 2) to determine whether carvedilol provides better control of blood     pressure between dialysis treatments than prazosin in patients whose blood pressure increases     during dialysis.   "
108756|NCT01862484|"     Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be     placed on a restriction diet for a 5 week period. Children will be randomized to either     receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a     double blind fashion. It is hypothesized that children who are consistently on the restricted     diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.   "
108757|NCT01862471|"     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among     hospitalized patients, with death occurring in approximately 6% of cases. It involves the     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to     blood vessel wall), collectively known as Virchow's triad.      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have     been shown to improve lower limb blood flow. However, few studies have directly compared the     two methods and those that have, have used outdated NMES devices.      The objective of this study is to compare the effectiveness of a modern NMES device to     intermittent pneumatic compression in terms of blood flow.   "
108808|NCT01861795|"     The purpose of this observational study is to collect data on vital signs, oxygen     requirements and other data related to ventilator care in preterm neonates under standard of     care treatment.   "
108760|NCT01862432|"     At birth, the passage from intrauterine to the aerial life can be considered as one of the     most stressful and painful life events. Skin-to-skin contact (STSC) with mother is known to     provide numerous virtues and World Health Organisation (WHO) recently supported the     introduction of such care among healthy, term-born neonates. Here, the investigators     hypothesized that immediate STSC could reduce neonatal, birth-evoked stress and pain. This     randomized controlled trial (RCT) aimed to compare the pain and stress response of C-section     born neonates that received either immediate STSC with mother (intervention) or classical     support and monitoring (control).   "
108761|NCT01862419|"     This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care,     or an electronic alert intervention. The electronic alert will be in the form of a text page     that will be sent to the covering clinician and unit pharmacist once per patient with AKI at     the time lab results are uploaded. The investigators hypothesize that such an alert will     improve outcomes in these patients.   "
108762|NCT01862406|"     Although generic drugs are pharmacologically equivalent to their brand-name counterparts,     prejudices against the former remain strong among patients and doctors. In a randomized     controlled field experiment, this research assesses the extent to which generic (versus     brand-name) labels affect patients' consumption dosage, medication compliance and reported     pain.   "
108778|NCT01862198|"     The purpose of this study is to investigate the feasibility and safety of endoscopic     ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.   "
108765|NCT01862367|"     This study is conducted globally. The aim of this observational study is to investigate the     incidence of specific adverse drug reactions associated with the use of recombinant factor     XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII     deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events     and lack of therapeutic effect.      The study will aim at observing all patients exposed to NovoThirteen® in the EU, and     additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered     in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.   "
108766|NCT01862354|"     The purpose of this randomized controlled study is to compare the postoperative analgesic     effect of a continuous wound infusion of local anesthetics and a sole transverse abdominal     plan (TAP) regional block in the surgery of Abdominoplasty Combined With Flank Liposuction.     Local anesthetics products used are ropivacaine combined with clonidine. Similar amount of     local anesthetics and clonidine are used.   "
108767|NCT01862341|"     In-Shape Nutritional Milk Powder is a nutritional milk powder containing fibers, probiotics     and other nutrients. This study will focus on the effects of fiber and probiotics on     digestive health and health well being in selected Filipino mothers   "
108768|NCT01862328|"     This is an open-label, multicenter, phase 1b, dose escalation study of MLN4924 plus     docetaxel, gemcitabine or combination of carboplatin and paclitaxel in adult patients with     solid tumors.   "
108769|NCT01862315|"     The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to     assess the effects this type of treatment has on the patient and the tumor. Liver pump     treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy     directly to the liver. Systemic chemotherapy gives chemotherapy through a vein [intravenously     (IV)] and treats the whole body. This type of treatment has been done before and had shown     that people with both pump and systemic chemotherapy had improved results. The investigators     hope that this combination of treatments improves the response to chemotherapy and reduces     the spread of the disease.      Another purpose of this study is to learn the clinical importance of a specific type of MRI     scan. The investigators would like to see if this type of MRI will help predict the response     to the treatment and see if they could help the physician with their treatment plan. These     scans will be done at specific time points.      The last purpose of this study is to learn more about how the tumor interacts with the     chemotherapy. This will be done through a biopsy taken during surgery and blood draws at     specific time points.      Permission from patients entering the study will be obtained to take normal and tumor liver     biopsies at the time of surgery. These samples are voluntary and optional.   "
108770|NCT01862302|"     Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce     the incidence, duration, and severity of post cardiotomy delirium?   "
108771|NCT01862289|"     Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment.     Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to     40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic     hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients,     those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an     additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled     (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis     of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest,     hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect     demographic information as well as information about asthma history, asthma control and     treatment.   "
108772|NCT01862276|"     To investigate the prognosis due to presence or absence of bile duct resection in     intrahepatic cholangiocarcinoma that require hepatic lobectomy.   "
108773|NCT01862263|"     The purpose of the study is to assess if the addition of vildagliptin as add-on therapy     improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately     controlled with insulin, with special emphasis in hypoglycemic episodes measured by     continuous glucose monitoring.   "
108774|NCT01862250|"     This research is being done to find out the safety of the investigational study     drug,clonidine HCL ( CLON). , in infants who are undergoing whole body cooling for the     treatment of hypoxic ischemic encephalopathy (HIE). The only known and effective treatment     for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling     process, babies get agitated, shiver and are uncomfortable. To treat these side effects     morphine is frequently used. CLON is very effective in decreasing shivering in adults and     children. Furthermore, in some preclinical studies, clonidine has been shown to be     neuroprotective (safe for the brain in models of brain injury)..This is a Phase I-II to     determine if low dose CLON will reduce the incidence of shivering and whether it has short     term cardiovascular safety. In this Phase I-II study, the investigators will determine the     (i) the maximum tolerated dose of CLON during cooling for HIE, (ii) the effects of CLON on     heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to     maintain constant blood flow to the brain) and (iii) association between blood levels and     changes in the above parameters. In this study the investigators hope to find ways to improve     sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our     ultimate goal is determine the potential neuro-protective properties of clonidine in newborn     babies with HIE.   "
108775|NCT01862237|"     This project focuses on the physiopathology of left ventricular remodeling associated with     type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve     replacement.      The main objective is to compare the reverse left ventricular remodeling between patients     with type II diabetes and case-control patients without diabetes at one(1) year after     surgical aortic valve replacement.      The secondary objectives are :        1. assess the influence of type II diabetes on left ventricular remodeling in patients          presenting with aortic valve stenosis,        2. assess the predictive value of myocardial fibrosis and other LV characteristics present          prior to aortic valve surgery on the LV reverse remodeling and their influence on          cardiovascular events at one (1) year after surgery,        3. assess the influence of type II diabetes on cardiovascular morbidity and mortality post          aortic valve surgery.      The investigators main hypothesis is that patients with type II diabetes and aortic valve     stenosis requiring aortic valve replacement have poorer LV function and less favorable post     surgery clinical outcomes than patients without type II diabetes.   "
108779|NCT01862185|"     Sepsis is a serious clinical condition with a considerable morbidity and mortality.     Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The     present study aimed to investigate the effect of semi-quantitative PCT test to the empirical     antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in     septic patients.      The hypothesis of the study are :        -  There is an effect on mortality between septic patients who do and do not do          semi-quantitative PCT examination        -  There is an effect on empirical antibiotic initiation time between septic patients who          do and do not do semi-quantitative PCT examination        -  There is an effect on appropriateness of empirical antibiotic between septic patients          who do and do not do semi-quantitative PCT examination      Study design is randomized diagnostic trial which is also a pragmatic trial.   "
108780|NCT01862172|"     Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy,     localized in the ipsilateral primary motor area, measured in mm, three months after     infarction of internal capsule.      The patient is compared to himself between day zero to ten and three months.      The study hypotheses are:        -  A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral          infarction of the internal capsule. It is measurable accurately and reproducibly by MRI          at three months. Other brain areas within the voluntary motor system will also be          explored (supplementary motor area, pre motor area).        -  This atrophy is correlated with achievement of pyramidal tract, assessed by the          fractional anisotropy of its fibers.        -  This atrophy is correlated with disability at three months, assessed by Rankin score.   "
108781|NCT01862159|"     The rate of serious complications are relatively low in bariatric surgery today, but still     3-4 % will suffer from a serious complication. There are factors known before the surgery or     during the operation that are likely to increase the risk for a serious complication. If the     investigators are aware of these we can optimize the patients risk factors prior to the     operation or at least increase the awareness of the increased risk in some patients given the     presence of risk factors.   "
108782|NCT01862146|"     Cigarette smoking is the most important modifiable cardiovascular risk factor leading to     endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the     study was to investigate the effect of smoking on vascular response to transradial coronary     angiography (TCA).   "
108783|NCT01862133|"     Health information technology, including health information exchange, offers the potential to     improve care by providing an integrated view of relevant, integrated patient information from     multiple health care providers practicing in multiple sites. However, realizing that     potential can be difficult, particularly with respect sensitive information. Increasingly,     patients, patient advocate groups, and even the National Coordinator for Health Information     Technology are pushing for patients to have more granular control over specifically who can     see what personal health information in their electronic health records.      This will be a demonstration project aimed at showing the initial feasibility a system     allowing patient controls on their electronic health records. Because of the exploratory     nature of the research, the investigators do not have specific hypotheses. The investigators     hope that this demonstration and feasibility project will lead to more extensive prospective     evaluations of patient control of access to their health records and other tools for     enhancing patient control over access to their health records.   "
108818|NCT01861665|"     The purpose of this trial is to compare incisional pain in patients receiving pre-incisional     versus post operative Marcaine injection.   "
108784|NCT01862120|"     Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key     role in the regulation of the immune system. At high doses, rhIL-2 activates the immune     effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells     (TREGS), a population of immune cells controlling the immune Teff response. In patients with     Type 1 Diabetes (T1D), TREGS fail to control the autoimmune destruction by TEFFS of     pancreatic beta-cells producing insulin. The investigator recently showed that rhIL-2 at low     dose is well tolerated in patients with an autoimmune disease and in adults with established     T1D, inducing TREGS without effects on TEFFS. The investigators aim to use rhIL-2 at low dose     to induce/stimulate TREGS in young recently diagnosed T1D patients. This study will     investigate the dose effect relationship of low dose rhIL-2 on TREG induction such as to     optimize the risk benefit ratio of this treatment in T1D. Through Treg induction, the     investigators aim to protect the remaining/regenerating pancreatic β-cells from autoimmune     destruction, thus improving or even curing T1D.   "
108785|NCT01862107|"     Background:      - Cerebrospinal fluid (CSF) is the liquid around the brain and spinal cord. Many diseases can     only be diagnosed by examining the CSF. A lumbar puncture is used to collect and test CSF.     Once someone is already having a lumbar puncture, a small extra amount of CSF can be     collected at the same time. This fluid can be used to study brain, nerve, and related health     issues. Researchers want to collect CSF and blood samples from people who are scheduled to     have a lumbar puncture.      Objectives:      - To collect cerebrospinal fluid and blood samples from individuals who are having a lumbar     puncture.      Eligibility:      - Individuals between 2 and 100 years of age who are scheduled to have a lumbar puncture for     clinical or research purposes.      Design:        -  Participants will have a lumbar puncture for clinical or research purposes.        -  During the procedure, an additional sample of CSF will be collected. They will also          provide a blood sample, if one is not taken at the time of the procedure.        -  Treatment will not be provided as part of this study.   "
108786|NCT01862081|"     This is an open-label, multicenter, dose-escalation study designed to assess the safety,     tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either     docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have     HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer     (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal     growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There     are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and     a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm     has been established from dose escalation, additional patients with each combination will be     enrolled in Stage 2.   "
117421|NCT01749098|"     To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal     learning and memory, episodic memory and spatial working memory in healthy volunteers.   "
108787|NCT01862068|"     Anti-neutrophil cytoplasm antibodies (ANCA)-associated vasculitis are rare diseases     characterized by inflammation of blood vessels. Among the numerous cell types that play a     role in vasculitis, one of the key actors is the neutrophil. Neutrophils are equipped with     very powerful molecules that they use to destroy the invading microbes. Therefore, the     mechanisms controlling neutrophil activation should be tightly controlled. If that is not the     case, neutrophils may destroy the tissues of the host. This is what happens during chronic     inflammation in vasculitis. Autoantibodies directed against neutrophils, ANCA, produced thus     demonstrating that neutrophils are also targets of the immune system in these diseases. In     addition, molecular studies provided evidence that genes normally silenced in mature     neutrophils under normal conditions can be re-expressed in neutrophils from patients with     ANCA-associated vasculitis thus strongly suggesting a profound deregulation of neutrophil     functions in these conditions. Notably, the investigators have preliminary data showing that     neutrophils from patients with granulomatosis with polyangiitis (GPA, formerly Wegener's     granulomatosis), an ANCA-associated vasculitis, interfere with the normal phase of resolution     of inflammation.      The objective of the investigators' study is to understand the mechanisms underlying this     increased activation state and determine if neutrophils could be used to define prognostic     markers by clinicians to optimize patients' care. Therefore, the investigators plan to study     the expression of proteins implicated in GPA pathophysiology at the membrane of neutrophils     when they undergo apoptosis. The investigators will also study the deregulation of protein     expression in neutrophils. This point will be the molecular translation of neutrophil     deregulation. This technique is powerful and well adapted to identify by mass spectrometry     the proteins that will be differentially expressed between the control and the disease state.     After identification of proteins differentially expressed in patients with GPA, the     investigators will further investigate whether their expression is modulated during the     disease course and/or modified by the treatment.      The investigators believe that understanding these neutrophil perturbations can lead to     better monitoring of disease activity. Ultimately, the investigators may propose more     targeted anti-inflammatory therapies which would be better tolerated by patients. the     investigators also can identify new markers for disease activity which allow clinicians to     define a better therapeutic strategy.   "
108788|NCT01862055|"     Spinal anesthesia is the technique of choice for planned cesarean section. It is associated     with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system     assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of     maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by     maternal stress that can be measured with salivary amylase. The goal of this study is to     assess the relationship between salivary amylase and severity of maternal hypotension after     spinal anesthesia for planned cesarean section.   "
108789|NCT01862042|"     The purpose of this study is to evaluate the quality of supportive and palliative care for     SMA type 1 patients.   "
108790|NCT01862029|"     Background:      - Roflumilast is a drug used to treat chronic obstructive pulmonary disease (COPD). It is     designed to help reduce lung inflammation. However, during testing, roflumilast also appeared     to reduce high blood sugar levels in people with COPD and type 2 diabetes. Other tests showed     that roflumilast also improved blood sugar levels in people who only had type 2 diabetes.     Researchers want to see how roflumilast affects insulin and blood sugar levels in overweight     or obese people who are not diabetic, but who have high blood sugar levels.      Objectives:      - To see how well roflumilast improves blood sugar and insulin levels in prediabetic     overweight or obese individuals.      Eligibility:      - Individuals between 30 to 65 years old who are overweight or obese (body mass index of 24.9     to 39.9 kg/m2) and have elevated blood sugar levels.      Design:        -  This study will last approximately 8 weeks. Participants will have approximately five          study visits over about 7 weeks. Two of these visits will be overnight inpatient stays.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. They will also have a 3-day diet and exercise assessment with          a dietitian.        -  In Week 1, participants will have a special diet for 2 days to keep their regular          weight. They will then have a 2-day inpatient stay. During their stay, they will have          multiple tests, including blood sugar tests and full body scans. They may provide a fat          and muscle tissue biopsy sample. They will then receive the study drug to take during          the study.        -  In Week 2, participants will repeat the diet study from the screening visit. They will          receive a different dose of the study drug.        -  In Week 3, participants will review their diet results and have blood and urine tests.        -  In Week 5, participants will repeat the diet and exercise study from the screening          visit.        -  In Week 6, participants will repeat the inpatient studies and tests from Week 1.      In the last week, participants will have a final follow-up visit.   "
108849|NCT01861262|"     The primary purpose of the protocol is to evaluate the StO2 performance measured at the     admission to the emergency department to identify hemodynamic failure at the admission or     within the first three hours of monitoring patients with drug poisoning.      The study hypotheses are:        -  The early detection of hypoperfusion by StO2, essential to prevent the development of          collapse.        -  To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning,          hospital stay and cost.   "
108850|NCT01861249|"     Primary Objective:      To assess the long term safety and tolerability of SAR339658      Secondary Objective:      To assess the long term efficacy of SAR339658   "
108791|NCT01862016|"     The care of acute respiratory distress syndrome (ARDS) has been significantly improved by     learning from experimental and physiological research works and by a series of randomized     controlled trials. The mortality of this syndrome remains however high. Numerous experimental     and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from     the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the     ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of     the ventilation while reducing the need for sedative drugs. This ventilatory mode could also     reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our     hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS     patients.      The aim of this multicenter, prospective, randomized, controlled, open study is to compare     the effects of two ventilatory strategies on the mortality of ARDS patients and placed under     mechanical ventilation.   "
108792|NCT01862003|"     Recruitment to phase I of the PANTHER trial is complete.      In phase II, the combination of AZD8931 and FOLFIRI will be compared to FOLFIRI alone, to     determine the efficacy of the treatment.   "
108793|NCT01861990|"     The study investigates valproic acid added to radiation and temozolomide therapy (standard of     care) for progressive or recurrent pediatric brain tumors.   "
108794|NCT01861977|"     The purpose of this study is to determine the effectiveness of a program to improve habits in     a population with cardiovascular disease, comparing two different educational techniques     (cognitive behavioral therapy group vs. informational workshops).   "
108795|NCT01861964|"     Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly efficacious     prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d), which is     much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or     galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves     diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may also     reduce blood cholesterol and may improve glycemic control, although more data from clinical     trials are needed to confirm preliminary findings.   "
108811|NCT01861756|"     A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision     aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool     will serve as a facilitator for the Shared Decision Making process.   "
109091|NCT01858077|"     To evaluate the efficacy and performance in an all-comers contemporary population of the     ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME     or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary     lesions.   "
108796|NCT01861951|"     Patients with a locally advanced or metastatic (i.e., there are already metastases of the     diagnosed tumor in the body outside the primary lesion) soft tissue sarcoma will be recruited     for this study. The minimum age to enter the study is 60 years.      Therapy with doxorubicin is the mainstay of palliative chemotherapy for these patients, which     is associated with hematological toxicity and an increase of the infection rate. Pazopanib is     known to rarely induce hematological toxicity or to trigger infection. We therefore assume     that pazopanib exerts similar activity while decreasing neutropenia and neutropenic fever.     Pazopanib is already approved in the U.S. and Europe for the treatment of advanced soft     tissue sarcoma.      Doxorubicin and pazopanib will be randomly allocated to either receive doxorubicin or     pazopanib in a phase II clinical trial. The aim of this study is to measure the treatment     effect (reduction in tumor size or tumor stabilization) for both drugs, as well as the     survival rate, and the duration of tumor control by the different therapies. A further     objective is to measure the quality of life by standardized questionnaires throughout the     course of treatment.   "
108797|NCT01861938|"     This study is based on the hypothesis that stimulation of the immune response against the     tumor can help destroy residual tumor in melanoma patients with very high risk for disease     recurrence and in patients with relatively low tumor burden who already got first line     treatment for their disease.      Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with     a cell line of tumor cells from the patient himself, or with a combination of three cell     lines that partially match the patient's cell characteristics, could improve the immune     response against the tumor, was associated with improved disease-free and overall survival.      In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine,     in terms of immune response,improved disease-free and overall survival. The vaccine consists     of a cell line that has a high expression level of melanoma molecules, and has been     genetically modified to induce a strong immune response.   "
108798|NCT01861925|"     The purpose of this study is to quantify in-vivo repeatability of a new corneal topography     measurement mode of an optical biometer, and the clinical performance of measurement in     comparison to reference devices.   "
108799|NCT01861912|"     The purpose of this study is to determine whether compared with arsenic trioxide TACE alone,     arsenic trioxide TACE and intravenous administration could further prolong the overall     survival.   "
108800|NCT01861899|"     The objective of this study is to gather clinical data on SI-LOK® for the treatment of     sacroiliac joint dysfunction.      The purpose of this prospective study is to evaluate clinical and radiographic outcomes,     intra-operative parameters, patient satisfaction and work status following a procedure using     SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.   "
108801|NCT01861886|"     To evaluate the safety and long-term (approximately one year) effectiveness of the Essure     System for Permanent Birth Control ESS505 device in preventing pregnancy.   "
108802|NCT01861873|"     Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning     assumes homogenous distribution of function in the normal liver tissue. In functional     treatment planning, additional information on distribution of the function derived from     functional imaging of normal tissue is taken into account. by functional treatment planning     it becomes possible to prioritize and spare the best functioning part of an organ.      Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the     best functioning liver tissue.      Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan     one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or     higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring     system that includes biochemical measures as well as symptomatic scores.   "
108803|NCT01861860|"     Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been     specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization     (AVIO) study was performed with (medical device's type )Promus stent, results are promising,     but the study was not designed for clinical endpoint.      There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely     used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were     recently proposed for complex lesions, but these criteria also have some issues and the     complexity make their routine use challenging.      We performed a pilot study for long complex lesion analysis using IVUS, in order to define     easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The     new criteria (OPERA) are an adaptation of the MUSIC criteria.      OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major     Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the     study.      Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element     stent deployment?      Study design This study will consist to prospectively include consecutive patients with>28mm     taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to     reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients     from the OTELLO study, with the same inclusion criteria, will composed the control group .     Population will be matched using the propensity score.      20 to 30 French centers involved in OTELLO study will be contacted for participating in     OPERA.      Hypothesis:      Long lesion percutaneous coronary intervention(PCI) have specific characteristics like     Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter     Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the     balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA     criteria have better outcomes than without IVUS      Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial     infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm     implantation      Secondary endpoint        1. MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria        2. Safety: procedural Stroke, Urgent cardiac surgery, procedural MI        3. Comparison of IVUS criteria: OPERA, MUSIC, AVIO      Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non     expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm     implantation with IVUS and OPERA criteria      Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric     study propensity score matched analysis matched for comparison to OTELLO study. (Same     inclusion criteria as OTELLO)      Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in     the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number     of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions.      Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts      Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months     telephone contact      Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization     (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery,     According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours   "
108804|NCT01861847|"     The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing     symptoms of Post-Traumatic Stress Disorder (PTSD).   "
108805|NCT01861834|"     To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based     intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable     oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver     transplantation.   "
108809|NCT01861782|"     Prospective open label crossover self controlled study. The study population will randomly be     divided into two groups.      The study will take place in Lot Spa Hotel at the Dead Sea in two cycles (one of 16     participants and one of 14 participants) and will be comprised of 3 main stages:        1. Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two          groups will have its own treatment protocol)        2. 12-month washout period        3. Crossover of the two groups and second exposure to treatment for 14 days excluding          Friday and Saturday (each of the two groups will have its own treatment protocol).      The population in the study will be composed of patients diagnosed and treated for rheumatoid     arthritis at the Soroka University Medical Center who are 18 and above of age.      The patients will be selected by the PI and his team and addressed regarding their     willingness to participate in the study.   "
108810|NCT01861769|"     Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their     lifetime. In the military veteran population, the lifetime prevalence of PTSD has been     estimated to be as high as 20%. Numerous research studies have demonstrated that short-term,     cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to     substantial improvements in PTSD symptoms. However, research suggests that a minority of     clinicians provide these therapies in clinical settings. The transfer of this research     knowledge into clinical settings remains one of the largest hurdles to improving the health     of Canadians with PTSD.      It is well established that attending a 2-day workshop on these therapies alone is     insufficient to promote adequate knowledge transfer and sustained skillful use. The current     study aims to contrast whether two forms of post-workshop support (6-month duration), with     different levels of expert oversight, will result in superior levels of clinician skill and     patient outcomes versus no formal post-workshop support. The three forms of post-workshop     support are 1) technology-enhanced group tele-consultation 2) standard group     tele-consultation 3) no tele consultation. The primary and secondary outcomes will be the     assessment of the clinicians' competence in CPT and patient symptoms,respectively. This study     will inform how best to transfer evidence based therapy outcomes to the clinical milieu to     attain comparable outcomes as those observed in research.      The investigators' hypotheses are as follows: Hypothesis 1:The technology enhanced group     tele-consultation condition will evidence the highest levels of fidelity, the standard group     tele-consultation condition will evidence intermediate levels of fidelity, and the     no-consultation/fidelity monitoring only condition will evidence the lowest fidelity.     Hypothesis 2: Fidelity to the CPT protocol, irrespective of consultation condition, will be     positively associated with improved client outcomes. Hypothesis 3: Organizational context     variables, such as the organizational climate and readiness for change, will influence the     uptake of CPT skills, as well as the extent to which these skills are utilized in practice.   "
108854|NCT01861197|"     Efficacy of Dovitinib for Squamous NSCLC.   "
108812|NCT01861743|"     Most patients undergoing surgery experience significant post-operative pain. Inadequate     peri-operative pain management may decrease post-operative mobilization and increase length     of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is     associated with an increased risk of developing chronic pain and delayed wound healing.      Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization.     The most common post-operative analgesia used in spine surgery is narcotic medication     delivered via an intravenous patient controlled analgesia (IV PCA).      A multimodal peri-operative pain management protocol for spine surgery has the potential to     not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease     length of stay in the hospital and reduce both direct and indirect hospital costs.      The purpose of this study is to determine if post-operative pain and rate of recovery are     improved in patients undergoing spine surgery using MMA compared to usual analgesic care.   "
108813|NCT01861730|"     Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and     dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly     in Bacille Calmette-Guerin (BCG) primed infants.   "
108814|NCT01861717|"     If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth     hormone) the treatment is to have it surgically removed. This study has two phases.      The first phase provides medical treatment with a drug that will be provided for 3 months     before surgery to see if complications of surgery are reduced and to see whether or not     remission improves following surgery if you have this medical treatment. The drug     administered is approved by the FDA for long-term treatment of acromegaly. It is not     routinely administered before surgery, and is therefore experimental as used in this way. All     other procedures performed during this research are standard of care with the exception of     the 3 questionnaires to be completed at each visit.      The second phase of this study is from 3 months until 12 months after surgery and is only for     people who do not go into remission after the operation. This phase assesses the possible     remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months.     The drug will be prescribed by your physician as part of your regular medical care and will     not be included as part of the study. All other procedures performed during this research are     standard of care with the exception of the 3 questionnaires to be completed at each visit.      The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.   "
108815|NCT01861704|"     Randomized post market study comparing Lyric to Lyric2 capturing information regarding     comparative performance and safety.   "
108816|NCT01861691|"     The long-term results of several large-scale prospective randomized trials that compared     laparoscopic-assisted and open colectomy for colon cancer were published in the past decade.     The oncologic outcomes were nearly similar in patients who underwent laparoscopic or open     surgery. In Japan, the Japan Clinical Oncology Group (JCOG) conducted a randomized trial to     compare oncological outcomes between patients who underwent laparoscopic or open surgery for     advanced colon cancer and recto-sigmoid cancer. However, the exclusion criterion were     concerning tumor site in transverse and descending colon. The reason of exclusion was that     laparoscopic procedure was difficult in transverse and descending colon cancers. However,     laparoscopic surgery for transverse and descending colon cancer was performed clinically. We     conducted a randomized trial that compared laparoscopic surgery and conventional open surgery     in in transverse and descending colon cancer. The purpose of the present study was to clarify     the safety and feasibility of laparoscopic surgery on in transverse and descending colon     cancer patients.   "
108817|NCT01861678|"     The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure     technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic     artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is     performed in practice. However, there is no evidence that shows effectiveness of this     technique.      We conducted a randomized trial that compared between high tie and low tie of the IMA in     rectal anterior resection to define an appropriate portion of IMA tying.   "
108819|NCT01861652|"     Restless legs syndrome (RLS) is a debilitating sleep disorder that has significant impact on     quality of life, and often times can be difficult to diagnose and treat effectively. RLS is     typically treated with medical therapy (including dopaminergic agents, dopamine agonists,     benzodiazepines, anticonvulsants, opiates, among other therapies). Many patients are either     refractory to medical therapy, have contraindications or adverse reactions to the available     medical therapies, or desire conservative non-medication based therapies. Two previous     studies have demonstrated that pneumatic compression devices placed on the legs can improve     symptoms of RLS. We would like to assess whether the Venous Health Systems Vasculaire leg     compression device improves symptoms and quality of life measures related to RLS in up to 40     patients evaluated prospectively for one month. This is a pilot study to assess the     subjective response of our cohort of patients to this device prospectively. Our hypothesis is     that over 66% of our cohort will demonstrate a positive symptomatic response based on RLS     specific quality of life questionnaires.   "
108820|NCT01861639|"     Episodic and working memory processes are the most affected cognitive domains in Alzheimer's     Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).      Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive     processes by inducing virtual and transient lesions, mimicking those observed in MCI. It     has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However,     to date, only few imaging data exist on the cerebral pathways involved in encoding memory     task. Moreover, the stability of TMS effects over time remains to be investigated. If proven     to be a stable interfering challenge, TMS could be used to investigate the potential     restoring effect of new medication in AD.      The study is the pilot study of a larger clinical trial which aims to prove the utility of     rTMS as a potential model for prediction of clinical efficacy using a combination of     cognitive and neuroimaging endpoints.   "
108821|NCT01861626|"     The purpose of this study is to evaluate the bioequivalence (comparison of the rate and     extent of the active substance into the body following single administration of the drugs)     between the test product V0057 and a reference product after two single oral administration     separate by 7 days.   "
108870|NCT01860989|"     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria     patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg,     225mg and 300mg/day   "
108822|NCT01861613|"     At present, children less than 15 y of age have been regarded as a key group for hepatitis B     immunization in China. However, there is not yet special immunization strategy for population     above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and     immune response to HB vaccine among Chinese college students to uncover the need on universal     mass vaccination or booster immunization only for students with HBV vaccination history     against hepatitis B in Chinese college students to inform decision making.   "
108823|NCT01861600|"     The primary efficacy objective was to determine and compare stool composition (stool soap and     non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the     feeding groups.   "
108824|NCT01861587|"     The purpose of this study is to determine whether a new medical technology can help reduce     post-operative pain. The new technology is called Transcranial Direct Current Stimulation.   "
108825|NCT01861574|"     The purpose of this research study is to investigate the effects of Transcranial Magnetic     Stimulation on pain perception. TMS is a non - invasive technique that uses electromagnetic     pulses to temporarily stimulate specificc brain area in awake people ( without the need for     surgery, anesthetic, or other invasive procedures.   "
108826|NCT01861561|"     Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in     juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous     cyclophosphamide can improve renal outcomes, but considerably associated with infection.     Although severe infection is the significant complication related to poorer prognosis for     juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice     for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous     cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable     with obtained high-dose regimen. There was lower number of severe infection episodes, but no     significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose     or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous     cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of     serious infection and improve overall patient outcomes.   "
108827|NCT01861548|"     The Polish Mother and Child Cohort is multicentre prospective study on different exposures.      Prospective cohort study design enables identification of exposures that may influence     pregnancy outcome and chil-dren's health, verification of such exposures by biomarker     measurements and notification of any changes in exposure levels.      The aim of the study is to evaluate the impact of exposure to different environmental factors     during pregnancy and after birth on pregnancy outcome and children's health. Specific     research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic     hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine     growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases,     allergy and poor mental and physical development. It is also intended to explain the role of     oxidative stress and nutritional status of the pregnant women. The impact of occupational     exposures and stressful situations on pregnancy outcome will be evaluated from question-naire     data.      The results of the study will help to determine levels of child prenatal and postnatal     exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and     children's health.      This protocol concerns the children that are followed-up from birth to the age of 2 years to     determine long term effects of pre- and postnatal environmental exposures.   "
108828|NCT01861535|"     To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs.     standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).   "
108829|NCT01861522|"     The objectives of this study are: to confirm the superiority of TAU-284 over placebo after     two weeks of administration to pediatric patients with perennial allergic rhinitis and to     investigate safety of TAU-284.   "
108830|NCT01861509|"     This study is an open label, non-randomized phase I single-armed study in women with     metastatic breast cancer (MBC) who have previously undergone all available standard     chemotherapy regimens. The purpose of the study is to estimate the pharmacokinetics (PK)     after single dose and multiple dose of BP-C1, investigate interleukin levels during BP-C1     treatment and assess treatment response according to RECIST criteria.   "
108831|NCT01861496|"     Liposomal formulations are frequently used today in the treatment of cancer. LiPlaCis is the     first targeted liposomal formulation with a tumour triggered release mechanism to undergo     clinical development in oncology and it is expected that LiPlaCis will improve the     therapeutic index of cisplatin compared to conventional cisplatin.      Cisplatin is one of the most widely used drugs in the treatment of cancer due to its     documented efficacy in a number of tumour types. Furthermore, it seems highly likely that     cisplatin will remain an important drug in the future treatment of cancer. However, the drug     is associated with a number of serious toxicities that complicates or necessitates     discontinuation of therapy - e.g. need for pre-hydration, neurotoxicity, nausea and vomiting.      Thus, there is a well-established need for improving cisplatin therapy in cancer patients.     One option here is improving the formulation of the drug, so that a more selective up-take of     cisplatin administered takes place at the tumour sites.      Based on the results of the pre-clinical studies of LiPlaCis, it seems clear that LiPlaCis     offers the potential to improve cisplatin therapy to the benefits of cancer patients.      In a prematurely stopped Phase I Dutch study a Recommended Dose (RD) for a Phase II study was     never reached which was the aim of the finished Phase I dose escalating part of this study     for advanced or refractory solid tumors.      In the Phase 2 part of this study, patients with advanced breast cancer with a biopsy     examination showing a pattern compatible with sensitivity to LiPlaCis or patients with skin     cancer will be included.   "
108832|NCT01861483|"     To investigate the vessel resection and reconstruction in biliary tract cancer.   "
108871|NCT01860976|"     The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of     psoriatic arthritis   "
108872|NCT01860963|"     This study is designed to establish the prevalence of anal squamous intraepithelial lesion     (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.   "
108873|NCT01860950|"     The purpose of this study is to determine whether a new medical technology can temporarily     alter pain perception. The new technology is called Transcranial direct current stimulation     (tDCS).   "
108833|NCT01861470|"     More than 8000 babies born >8 weeks early or weighing less than 1500g at birth in the United     Kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (ROP).     Less than 1 in 10 need treating, but to identify these all of them require eye examinations     1-2 weekly from 5 weeks. These tests are uncomfortable, upsetting for families, and cost     considerable time and money.      There is now a new urine test that might help identify babies with the highest risk of     developing significant ROP. This cheap test appears to predict which babies need treatment     and could avoid invasive eye examination in thousands of babies. The test has so far only     been used in 136 babies. It accurately predicted ROP, but 136 babies cannot change practice.     We need to test more babies including in the UK. This study is designed to test >300 UK     babies to see how accurately urine levels of NTproBNP predict development of ROP needing     treatment.      We will also pool our data with other researchers across Europe testing the same test to     identify the best 'cut'-off' value for this test. In the future babies with urine levels of     this chemical lower than this cut-off level would not need invasive eye examinations.      If this test works as we hope it will many babies will avoid repeated painful eye tests, and     their families will be saved the stress of watching this being done, by replacing these with     a simple easy cheap pain free urine test. There will be substantial savings in health care     costs that could be used to improve other aspects of care. In resource poor settings without     an expert ophthalmologist babies could be screened for ROP that currently cannot be screened.      We hope to demonstrate this to be a family-friendly, achievable intervention that positively     impacts on the lives of babies and families experiencing neonatal intensive care.   "
108834|NCT01861457|"     The purpose of this study is to determine the extent to which bacterial growth in the     nostrils by S. aureus, a common bacteria that is found in hospital environment, can be     reduced by NOZIN® Nasal Sanitizer® antiseptic nasal swabs during the course of a typical     10-hour work period in participants known to have S. aureus in their nose passages.   "
108835|NCT01861444|"     This prospective, multicenter, observational study will assess the prevalence of chronic     hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of     Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients     treated with Pegasys according to current medical practice will be followed until 24 weeks     after the end of treatment.   "
108836|NCT01861431|"     The proposed study aims to test the feasibility and preliminary efficacy of a combined     4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34     training session and matched savings) to reduce unprotected sex and to increase proportion of     income from sex work among women engaged in high risk sexual activity in Ulaanbaatar,     Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical     trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility     screening, eligible women will complete informed consent, a baseline assessment, and be     randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus     microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition.      The study design will permit us to:        1. Examine and enhance the feasibility (i.e. recruitment, engagement, attendance, retention          data collection) of a combination HIV sexual risk reduction and MF intervention with          high risk women in Ulaanbaatar, Mongolia;        2. Examine the preliminary outcomes of the interventions on decreasing unprotected acts of          vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal          acts using barrier protection and decreasing number of sexual partners with repeated          measures at baseline, immediately post-intervention, and 3 and 6 month follow-up          assessments.        3. Use the results of the pilot study to inform the design of a future R01 application.   "
108837|NCT01861418|"     The purposes of this study are:        1. To examine the within-day and between-day test-retest reliability of a testing protocol          measuring the back and hip muscles fatigability using EMG median frequency        2. To examine the immediate and the carry-over effects of the lumbopelvic manipulation on          the EMG median frequency of the lumbar multifidus (MULT), gluteus medius (GMED) and          gluteus maximus (GMAX) muscles in patients with chronic low back pain (CLBP)        3. To compare the fatigability levels of the MULT, GMED and GMAX muscles by measuring the          EMG median frequency between the participants who will receive lumbopelvic manipulation.      The research hypotheses are:        1. The testing protocol using EMG median frequency as a fatigue indicator for MULT,GMED and          GMAX muscles will have good (ICC ≥ 0.80) within-day and between-day test-retest          reliability.        2. The fatigability level of the MULT, GMED and GMAX muscles will significantly decrease          immediately after the lumbopelvic manipulation and will be maintained over two to four          days following the manipulation.        3. The fatigability of the MULT, GMED and GMAX muscles will significantly decrease after          the intervention in the manipulation group while no change will occur in the placebo          group.   "
108851|NCT01861236|"     Prospective, observational study to collect and analyze data on patients with advanced     hormone dependent prostate cancer treated with Firmagon® according to routine medical     practice in Argentina   "
108852|NCT01861223|"     To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to     gefitinib or erlotinib.   "
140663|NCT01443364|"     The study aims to evaluate the predictability of early response to Certolizumab pegol in     combination with Methotrexate at one year in patients with moderate to severe rheumatoid     arthritis.   "
108838|NCT01861405|"     The investigators seek to perform an observational study in patients with brain metastases     that are to undergo whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS)     treatment in order to quantify any baseline neurocognitive changes which may result from     intracranial disease burden, from radiation treatment (WBRT or SRS), or both. To do so, the     investigators will compare matched control subjects to patients at time points obtained     before and after radiation treatment with either SRS or WBRT. Pre-treatment evaluation will     include neurocognitive testing and an assessment of fMRI task-related activation patterns and     resting state brain activity. Four and twelve month post-treatment neuropsychological     evaluations will be performed and pre- and 4-month post-treatment fMRI scans will be obtained     in order to evaluate changes in neurocognitive functioning with a focus on short-term memory     and executive function domains. A brief quality of life assessment will also be completed at     each study time point. In order to plan treatment strategies in the future it is important to     accurately document the effects of intracranial disease burden as well as radiation treatment     on neurocognitive functioning, validate fMRI activation tasks for short term memory and     executive functioning, and quantify the activation volumes that would potentially be spared     in future cognitive sparing protocols.      The investigators hypothesize first that the amount and location of intracranial disease     burden will represent pre-treatment variables that affect NCF. The compromised NCF will be     visualized in both the resting state and task-oriented neurocognitive exercise. The     investigators anticipate that any perturbation in resting state caused by intracranial     disease burden should be reflected in patients when compared to matched controls.      The investigators hypothesize additionally that cancer patients with brain metastases     undergoing radiation treatments will have improved intracranial disease control at the     expense of executive and memory function with differences between patients that undergo     stereotactic radiosurgery or whole brain radiation alone.   "
108874|NCT01860937|"     The purpose of this study is to test the safety of giving the patient special cells made from     their own blood called Modified T-cells. The goal is to find a safe dose of modified     T-cells for patients whose leukemia has returned to the bone marrow.   "
132428|NCT01551602|"     The objective of this study is to investigate the pharmacokinetics, safety, and tolerability     of AK159 administered to healthy postmenopausal women.   "
108839|NCT01861392|"     Background: The individual's ability to sustain itself in the upright position, effectively     adjusting the body's movements and reacting to external stimuli, postural control strategies     represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is considered     a more problem of Public Health as having complications deficit in functional performance of     the lower limbs and falls, which can interfere with the maintenance of balance, and is a     strong predictor of functional limitations self referred. Aim: To assess quality of life and     the answers neuromuscular balance and baropodometric after sensory-motor training in patients     with type 2 diabetes. Method: To be recruited 50 volunteers aged between 45 to 64 years with     DM-2, of both sexes, divided into two groups: 1) Guidelines and 2) Guidelines + sensory-motor     training. Biomechanical data will be collected (balance, baropodometry, electromyography     strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The     intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases:     heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood     glucose. There will be a follow up after 3 months of intervention. Statistical analysis will     be used normality test to verify the data distribution and consistent statistical test for     the appropriate comparisons within and between groups, and adopted a significance level of     5%. Expected Results: Considering previous studies that demonstrate improvement in postural     balance static and dynamic responses under the forward training protocol sensorimotor disease     Diabetes mellitus type 2, is expected to improve neuromuscular, balance, distribution plant,     the joint position sense and the quality of life of voluntary DM-2.      Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus,     quality of life.   "
108840|NCT01861379|"     To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a     prospective randomized controlled study comparing 2 groups of patients undergoing anterior     resection of the rectum laparoscopically. In the first group of patients at the end of the     procedure was always performed a Ghost Ileostomy while in the second group no protective     stoma was built at the end of the intervention.   "
108841|NCT01861366|"     The aim of this study is to examine two implementation strategies (external facilitation and     educational outreach visit) when introducing nutritional guidelines in the elderly care     setting and to evaluate the results of the implementation by clinical outcome measures of the     nursing home residents.      The hypothesis is that the residents affected by the external facilitation strategy will stay     stable in the measured clinical outcomes, while the residents influenced by the educational     outreach visit will deteriorate during the implementation process.   "
108842|NCT01861353|"     Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and     in adults in our earlier clinical trials. The preventive effect was, however, observed late     in the follow-up and the next recurrence was not prevented in children. The investigators     hypothesize that cranberry-lingonberry juice should be started already during the     antimicrobial treatment of acute urinary tract infection in order to maximize the preventive     efficacy of the juice. In addition, the investigators aim to find the explanation for the     efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical     composition of urine and feces as well as the changes of gut microbiota.   "
108843|NCT01861340|"     This research study is being done to see if combining the investigational chemotherapy drug,     MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your     myeloma cancer stem cells.   "
108844|NCT01861327|"     Prospective randomized comparison between endovascular procedures performed with iodinated     contrast or carbon dioxide as intraarterial contrast.   "
108845|NCT01861314|"     This phase I trial studies the side effects and the best dose of bortezomib and sorafenib     tosylate when given together with decitabine in treating patients with acute myeloid     leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine,     work in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving bortezomib and     sorafenib tosylate together with decitabine may work better in treating acute myeloid     leukemia.   "
108846|NCT01861301|"     This phase II trial studies how well tivantinib works in treating patients with previously     treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
108847|NCT01861288|"     We hypothesize that the number of needed endoscopic procedure performed at IBD patients     (adult and children), can be reduced by using an individualized algorithm of symptoms, blood     and faecal biomarkers.      The aim of the study is to reduce the numbers of endoscopies, as the procedure is     uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood     test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we     want to construct an algorithm by which the intestinal healing can be foreseen without     performing an endoscopy.      Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score,     with the histo-pathological inflammation score from intestinal biopsies and the immunological     score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order to assess the     gold standard - endoscopic remission.   "
108848|NCT01861275|"     Obstructive sleep apnoea is a risk factor for ischaemic stroke. study hypothesis: In     prospective study the investigators want to know how many ischaemic stroke patients have     sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.   "
109055|NCT01858545|"     The primary objective of this study is to assess the effectiveness of MatriStem devices     compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic     foot ulcers.   "
108853|NCT01861210|"     This is a study to determine whether testing for HIV together as a couple, as opposed to     testing separately, in acceptable to men in male couples, and is a safe prevention service.     Testing of couples together has been provided for decades in Africa, but has never been     tested in the United States. In this study, male couples will be enrolled and randomly     assigned to be tested together in the same room, or separately. At the time of testing,     investigators will ask questions about how they felt about the service they received. Three     months later, investigators will survey the men again, and determine whether they had any     problems after the testing, like violence in the relationship or the relationship breaking     up. The main outcomes are being satisfied with the testing service, and safety (lack of     intimate partner violence or relationship termination). Although the study is not designed to     determine if the service reduces risk behaviors for HIV transmission, investigators will     examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at     least as satisfied with couples testing as they are with individual testing; and (2) men     tested as couples will not experience higher rates of intimate partner violence or     relationship dissolution, relative to men tested separately.   "
108855|NCT01861184|"     We are interested in developing new and better ways of diagnosing the cause of lower     respiratory tract infections including pneumonia. Currently we find the causal bug (bacteria     or virus) in less than 50% of patients with pneumonia. A potential way to better find the bug     responsible may include checking for bugs in the nose by a nasal wash or swab. Better     diagnostics would allow more targeted antibiotic therapy and in the future this technique may     be used as a way of checking the efficiency of new vaccines.      We are recruiting both patients with respiratory infections and also a 'control' group of     patients admitted to hospital who do not have respiratory infection. We need to have access     to your medical history information to make sure you are eligible and suitable for the study.     If you participate in the study, it is important that the study doctors continue to have     access to your personal Investigator Designation Contact telephone Dr Andrea Collins PhD     student/research SpR xxxxxxxxxxxxx Carole Hancock Research nurse 0151 706 4856 Prof Stephen     Gordon Principle Investigator 0151 705 3169 NW PIL V1.3: October 2012 REC ref: 12/NW/0713     information so you can be followed up properly and so we can contact you during the study if     needed.      Patients in both groups will have a nasal wash (or swab), blood (30mls = 6 teaspoons) and     urine taken on the day of recruitment and a nasal wash (or swab) and blood (30mls = 6     teaspoons) taken 6 weeks later (this is likely to be as an out-patient at the Royal     Liverpool, in extreme circumstances this will occur at the patient's home).   "
108856|NCT01861171|"     The purpose of this study is to evaluate the effects of green tea on body weight, waist     circumference, metabolic profile, inflammation, blood pressure and endothelial function in     obese pre-hypertensive women.   "
108857|NCT01861158|"     This study evaluates Parenting Wisely (PW), an interactive, computer-based, online parenting     program, through a formal randomized trial conducted in collaboration with the juvenile     justice system (JJS), the primary market for such a program. Parents of 450 delinquent     receiving JJS services as usual (SAU) will be randomly assigned to: PW plus a social     networking online discussion forum, PW alone, or SAU. The investigators will also determine     the potential marketability of the PW intervention to JJS programs based on the effects of PW     on parent report and direct observation measures of parenting behaviors, adolescent     behaviors, and family functioning, as well as measures of recidivism and cost savings. User     satisfaction, program comprehension, receptivity, and parent self-efficacy will also be     assessed. The investigators hypothesize that the two PW interventions (PW only and PW +     Social Network) will produce greater reductions in disruptive behavior problems from baseline     to 3- and 6-month assessments compared to SAU.   "
108858|NCT01861145|"     Enuresis (E) or bedwetting is a common pediatric complaint, and recent research has     discovered a link with obstructive sleep apnea (OSA). In children, OSA is often secondary to     enlargement of their adenoids or tonsils, and is often successfully treated with a steroid     solution given through the nose.      The relationship between SDB and E is incompletely understood. Airway obstruction affects the     quality of sleep, as the child will wake as the oxygen levels drop. Abnormal sleep also can     decrease the secretion of hormones that affects the kidney's ability to concentrate urine at     night, which can result in too much urine in the bladder. Contemporary evidence also suggests     that patients with enuresis have abnormal sleep phases, which may impair the communications     and inhibition of the bladder.      In previous studies, the investigators have demonstrated that children with E have a high     likelihood of having concomitant SDB. The investigators have also demonstrated that children     with E and symptoms of SDB do not respond to typical management for bedwetting. Therefore,     the investigators propose to treat patients presenting with E with our standard treatments     for E (bed alarm) and first line therapy for SDB: Intranasal steroids. This medication helps     to decrease the inflammation of the adenoids and tonsils, thereby reducing the airway     obstruction. the investigators hypothesize that children with significant symptoms of SDB     will improve with the addition of INS, and the investigators hope to see an improvement in     their bedwetting, quality of life, and sleep quality as well.      To test this, patents with E will be recruited from the pediatric urology clinic. They will     be offered the standard treatment for E, the bed alarm, and the treatment group will be given     an intranasal steroid spray. The investigators will then reassess the patients 3 months after     treatment, and compare the two groups.   "
108859|NCT01861132|"     Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive     monitoring devices are desirable, but until now, no equipment has proven validity. This study     aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in     pregnant women.   "
108860|NCT01861119|"     Hypertrophic or keloid scars develop for about 39% to 68% of patients after surgery. The     subjective opinion of the patient regarding the scar will often constitute the standard for     judging the success or failure of the procedure. Surgical scars are not only a cosmetic     concern but they can also cause pain, itching, discomfort, contracture, and other functional     impairment. Various treatment options exists for treating hypertrophic scars and keloids,     including intralesional steroid injection, dermabrasion, pressure therapy, surgical excision,     radiotherapy, cryotherapy, pulse dye, and carbon dioxide laser ablation. However, these     treatments often require multiple visits and have limited success. Therefore, prevention and     early recognition of hypertrophic scars and keloids are very important in their management.      Among preventive treatments available, silicone gel and onion extract gel have been marketed     as products to improve the appearance and texture of surgical scars. Despite its popularity,     data demonstrating the efficacy of these gels are lacking. Furthermore, there is no     comparative study of silicone gel and onion extract gel for preventing postsurgical     hypertrophic or keloid scars. The investigators therefore conducted this randomized     controlled trial to compare the efficacy of silicone gel and onion extract gel for the     prevention of postsurgical hypertrophic scars. The investigators also compared patient     compliance and side effect between two topical gels.   "
108875|NCT01860924|"     In this project the investigators will develop and pilot test a supervised, vigorous     intensity exercise intervention for depressed female smokers. If the pilot intervention is     successful the investigators will have a blueprint for a large randomized controlled trial.     The long term objective is to develop interventions for depressed women that will ultimately     reduce their risk of tobacco-caused disease and mortality.   "
108876|NCT01860911|"     Increased accumulation of fat into the muscles is associated with what is called     insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to     find out how fat circulating in the blood following fat consumption is taken up by the     muscles in healthy people as well as people that are insulin-resistant. The investigators are     specifically interested in how a hormone called insulin is involved in this process. Findings     from this research will contribute to our understanding of why insulin-resistant people have     increased accumulation of fat in their muscles, and ultimately help to design appropriate     interventions to prevent type 2 Diabetes.   "
118583|NCT01733810|"     The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on     the production of inflammatory cytokines that lead to reflux esophagitis.   "
108862|NCT01861093|"     Background:      - Cord blood is blood that is taken from the umbilical cord and placenta of healthy newborns     after childbirth. The cord blood collected from a baby is called a cord blood unit. Cord     blood units are stored frozen in public cord blood banks. About 10,000 cord blood transplants     have been performed in children and adults for blood cancers and other diseases in the world.     These transplants have helped save lives and improve treatments. However, not all available     units of cord blood have been collected, stored, and licensed according to specific     government requirements. These unlicensed units can still be used in transplant, but they can     only be given as part of specific research studies. This study will evaluate the safety of     giving these unlicensed units by recording any problems that may occur during and after     giving the cord blood.      Objectives:      - To test the safety and effectiveness of unlicensed cord blood units in people who need stem     cell transplants.      Eligibility:      - Individuals who are scheduled to have a stem cell transplant.      Design:        -  Participants will be screened with a medical history and physical exam.        -  Participants will receive the cord blood unit as part of their stem cell transplant          procedure. The transplant will be performed according to the current standard of care          for the procedure.        -  After the transplant, participants will be monitored for up to 1 year. Any problems or          side effects from the transplant will be treated as necessary. All outcomes will be          reported to the National Cord Blood Program and to the Center for International Blood          and Marrow Transplant.   "
108863|NCT01861080|"     The objective of this study is to know prevalence of clinical or subclinical target organ     damages in Korea hypertensives by constructing nationwide hypertension registry. We will     register 5000 consecutive patients with incident hypertension at 20 major university     hospitals in South Korea. We will investigate clinical/subclinical target organ damages,     renin/aldosterone level and cardiovascular events in each patient.   "
108864|NCT01861067|"     During the last 2 decades, several studies have tried to define the best surgical approach to     hysterectomy for benign uterine diseases1. Accumulating evidence demonstrates that abdominal     hysterectomy has a higher incidence of complications, a longer hospital stay and a slower     convalescence in comparison with laparoscopic hysterectomy (LH). The main advantage of LHs is     the absence of a wide abdominal scar, which results in fewer wound-related complications and     in a significant decrease of postoperative pain.      Technologic advances in endoscopic instrumentation and optics have allowed the development of     an even less invasive procedure than conventional LH using multiple ports: laparoendoscopic     single-site (LESS) surgery, also known as single-port access (SPA) laparoscopy3. In the LESS     approaches, total laparoscopic hysterectomy (TLH) and laparoscopically-assisted vaginal     hysterectomy (LAVH) are all feasible, with comparable conventional LH. However, it is yet to     be determined which of two alternative and less invasive approaches (LESS-TLH and LESS-LAVH)     should be preferred. In particular, none has focused on postoperative pain as the primary     outcome of the study. The investigators have therefore designed the randomized trial to     investigate specifically differences in postoperative pain after LESS-TLH and LESS-LAVH.   "
108865|NCT01861054|"     This is a pilot window of opportunity clinical study in patients with operable breast     cancer investigating use of reparixin as single agent in the time period between clinical     diagnosis and surgery. This study evaluates the effects of orally administered reparixin on     CSCs in the primary tumor and the tumoral microenvironment in an early breast cancer     population. The aim is to investigate if cancer stem cells (CSCs) and pathway markers     decrease in two early breast cancer subgroups (ER+ and/or progesterone receptor     positive/HER-2- and ER negative/progesterone receptor negative/HER‑2-) and to compare any     differences between the two subgroups to try to better identify a target population. 20     patients will be enrolled to each subgroup at ten sites in the US.   "
108866|NCT01861041|"     Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose     hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We     compared the efficacy and duration of the spinal block with two different bupivacaine     baricities.        -  Group I: low dose isobaric group        -  GroupII: Low dose hyperbaric group   "
108867|NCT01861028|"     This study compares intraoperative fit of the patient-specific iTotal knee replacement to     other standard knee replacement implants   "
108905|NCT01860534|"     Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can     persist for hours. Despite regular use of eye protection for mydriatic-induced light     sensitivity for infants, children and adults, eye protection after mydriasis has not been     addressed in neonates. This study examines the use of eye patches to protect the dilated     pupil from light exposure and their impact on vital signs and pain scores. prevents     tachycardia, tachypnea and discomfort in neonates after ROP screening.   "
109056|NCT01858532|"     This study is being conducted to evaluate the effects of Atrasentan on Renal Outcomes in     Subjects with Type 2 Diabetes and Nephropathy.   "
108868|NCT01861015|"     Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female     genital tract and the leading indication for hysterectomy. Although hysterectomy is the     definitive treatment of myomas, myomectomy remains the gold standard treatment for women     desiring future fertility and uterine conservation3. However, bleeding is often a problem in     myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic     infection, and adhesions with infertility.      A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two     categories of interventions can be identified: (a) Vascular interventions on uterine and/or     ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic     interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol,     sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative     local injection of vasopressin causing vasospasm is most commonly used. However, there is not     a wide consensus on the use of this agent because of serious side effects reported in     literature. In addition, in several countries, including France and Italy, vasopressin has     not been commercialized because of its potential adverse effects on cardiovascular system.      Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of     vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological     surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However,     there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy.     Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents     during myomectomy has never been conducted. To test the hypothesis that the injections of     epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the     investigators performed this randomized controlled study.   "
108869|NCT01861002|"     This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility     of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5     days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid     leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary     treatment or who relapsed.   "
108877|NCT01860898|"     As part of the long-term goal of successfully implementing tissue regeneration strategies in     an individualized manner for patients with thoracic diseases including, but not limited to:     cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess     the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic     disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts     into induced pluripotent cells.   "
108878|NCT01860885|"     Opioids are the mainstay of analgesia in hospitalized children but opioid therapy is     associated with life-threatening respiratory depression requiring antagonism with naloxone.     Hence, it is hypothesized that naloxone requirement can be used as a quality measure of     opioid safety. A retrospective medical chart review of 95 patients, who received naloxone for     life threatening events, from June 2006-2012, is planned, to identify significant factors     associated with risk for opioid induced respiratory depression and formulation of preventive     strategies.   "
108879|NCT01860872|"     The purpose of this research is to learn more about the heart and blood vessels in the lungs     of people with cystic fibrosis (CF). This study will include approximately 36 children and     adults with CF and 12 children and adults without CF. The study will involve one magnetic     resonance imaging (MRI) . The research also includes blood samples to look at inflammation     and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple Breath     Washout test.      For the CF subjects, enrollment will be timed to coincide with routine scheduled computerized     tomography (CT) or the CF subject may choose to have a CT for research purposes. The MRI will     be compared to CT images of the lungs. The goal is to develop better imaging that does not     use radiation.   "
108880|NCT01860859|"     This study compares three techniques of uterine closure on myometrium thickness evaluated by     ultrasound six months after the primary cesarean. The three techniques include: 1) locked     single layer closure; 2) double layer closure with a first continuous locked suture and a     second imbricating continuous suture; 3) double layer closure with a first continuous     unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua     and a second unlocked continuous suture that approximate the upper portion of the myometrium.     The primary outcome is the mean myometrium thickness at the site of the uterine scar     evaluated by transvaginal ultrasound at six months after cesarean.   "
108881|NCT01860846|"     This multicenter, prospective, post marketing observational study (PMOS) was designed to     demonstrate long-term effects of anti-Tumor Necrosis Factor therapies on Work Productivity     and Impairment scales in participants with moderate to severe Crohn's Disease (CD) under     routine conditions. Secondary objectives of this study were long-term improvement of Quality     of Life (QoL), evaluation of improvement of extraintestinal symptoms and comorbidities, and     evaluation of safety.   "
108882|NCT01860833|"     Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local     inflammation (which involves production of pro-inflammatory cytokines such as interleukin     (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.      Certain therapies that specifically interfere with the expression or actions of     pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and     anti-inflammatory properties and are extensively prescribed for several musculoskeletal     disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently     recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients.     These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA     patients with satisfactory relief of painful osteoarthritic joints.      The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6,     IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular,     diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships     between proinflammatory cytokines and the clinical status of OA patients are possible, we     also evaluated the association between the concentration of these molecules in the     osteoarthritic knee synovial fluid and the pain and functional status of patients with OA.     The effects of NSAIDS on signal transduction pathways in the synovial membrane were also     investigated.   "
108883|NCT01860820|"     This will be a randomized, controlled trial involving kidney and kidney pancreas transplant     patients. There will be 2 groups and patients will be randomized to one of the two; one will     receive standard of care IPC or TED stockings to help with circulation, the other group will     use the geko device which is a newer device with Health Canada approval. Clinical outcomes     will be compared for those in each group and clinical differences between patients who     receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.   "
108884|NCT01860807|"     The objective of this study is to test the safety and potential efficacy of ibudilast to     treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce     methamphetamine use and increase treatment retention more than placebo among patients seeking     treatment for methamphetamine dependence. As HIV infection is a common complication of     methamphetamine dependence, half of the participants will be HIV positive and the study will     assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence, CD4     count, risk behaviors).   "
108885|NCT01860794|"     The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic     Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.   "
108886|NCT01860781|"     The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within     three different group of schizophrenia patients.   "
108896|NCT01860651|"     The investigators hypothesize that E-health - web based monitoring of disease and treatment -     in young patients with chronic inflammatory disease (IBD) can improve the disease course and     quality of life.      Adherence (to take the prescribed medicine) is difficult for young patients. In this E-health     project the investigators seek to improve young patients (10-17 years) responsibility for     treatment, to empower them and thereby enhance the adherence in order to achieve a more quiet     disease course. Through the e-Health program and web-app the disease activity will be     presented to the young patient via a simple traffic light chart and the patient will be     guided to: continue the prescribed medication, call the physician or visit the out-patient     clinic. In future the concept is believed also to be applicable for young patients with other     chronic diseases.   "
118584|NCT01733797|"     The trial will compare exercises using Therabite® versus wooden spatulas to prevent or     relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.   "
108887|NCT01860768|"     Acute aortic dissection (AAD) is an acute vascular lesions with high early misdiagnosis     rate(31.8%), and mortality rate was 38%. In recent years, the incidence is rising and serious     threat to human health. At present, the clinical diagnosis of AAD commonly used imaging     methods, including chest X-ray, B ultrasound, CT, MRI and aortic angiography. Chest X-ray and     two-dimensional ultrasound is limited in diagnosis of AAD, esophageal ultrasonography can     display the intimal, identify the true and false lumen, but greater risk. CT, MRI and aortic     angiography can be used as diagnosis method, but time-consuming, expensive and requires     handling patients in emergency situations, should not be used as the preferred. Therefore, it     is significance that biomarkers with high specificity and sensitivity for clinical fast     diagnosis of AAD.      Parts small sample tests found that single serum α-smooth muscle actin (α-SMA), myosin heavy     chain(MHC) and human soluble elastin fragments (sELAF) levels in patients with AAD were     significantly higher than that of others (normal people, acute myocardial infarction     patients). But because of the small study sample, limited control risk factors and incomplete     comparison, their conclusions were questionable. In our previous studies also found that     serum α-SMA, MHC and sELAF levels and the pathogenesis of AAD and prognosis are closely     related. Therefore, on the basis, a prospective study is needed. We observe all the three     biomarkers in enrolled patients with acute chest pain in emergency department, levels in     healthy volunteers as the blank control. Then make definite diagnosis of the enrolled     patients, and further observe the biomarkers dynamic change in AAD. Lastly, evaluate the     early diagnostic value of combination serum α-SMA, MHC and sELAF level on patients with AAD.   "
108888|NCT01860755|"     The purpose of this study is to determine the effects of a combined physiotherapy treatment     (including vestibular rehabilitation and treatment for the cervical spine) in youth and young     adults with ongoing symptoms of dizziness, neck pain and headaches following a sport-related     concussion.   "
108889|NCT01860742|"     The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b     in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine     tumors resistant to therapy with somatostatin analogues, in terms of disease control.   "
108890|NCT01860729|"     This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol     (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with     hypercholesterolemia when added to an existing statin therapy.   "
108906|NCT01860521|"     This study included women who underwent voluntary second trimester termination of pregnancy.     Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous     epidural infusion for pain analgesia. In this randomized, double-blind study, the     investigators assess the incidence of motor block (primary outcome), degree of satisfaction     of the patients, total levobupivacaine and sufentanil consumption and adverse events     (secondary outcomes) between the two study groups.   "
108907|NCT01860508|"     PFS   "
108908|NCT01860495|"     One of the most important elements suggested to be provided through membrane perforations to     augment regeneration are cell released growth factors from the overlying periosteal and     gingival cells. A direct correlation could exist between the number of such cells and their     available released growth factors. To test this assumption, this study was designed to     evaluate levels of bone morphogenetic protein-2 in gingival crevicular fluid (GCF) during the     early stages of healing for sites treated by MPM compared to that of the occlusive barrier     membranes.   "
108909|NCT01860482|"     The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients     with refractory reflux esophagitis to the prior standard PPIs regimen.   "
108891|NCT01860716|"     Impact of melatonin on organ donor pretreatment and liver transplant recipient: prospective,     randomized, double-blind trial.      OBJECTIVES. To establish the efficacy of the melatonin administered to encephalic death     donors (EDD) in liver transplantation. The aim is to improve the functional quality of the     retrieved organs, attenuate lesions and ischemia-reperfusion mediators, and provide grafts     with greater resistance to post-transplant aggression.      METHODOLOGY. Prospective, randomized, double-blind, pilot trial to evaluate preconditioning     with melatonin versus placebo in EDDs. Two groups, melatonin and control-placebo, n=30 per     group. Administration to donor via NG tube of 30mg of melatonin or placebo (lactose) upon     inclusion in the trial, 60 minutes prior to commencement of surgery and following laparotomy     during extraction. Evaluation of response to treatment: A) Conventional clinical,     hemodynamic, analytical and histopathological parameters in donor and recipient. B) Plasma     determinations for: oxidative/nitrosative stress; acute phase proteins; cellular and humoral     immunity; NT-proBNP and cystatin C; endocrine profile; melatonin levels. C) Determinations in     liver tissue: quantification of malonyldialdehyde-4hydroxyalkenals and protein carbonyl     content; cellular and mitochondrial membrane fluidity; markers of tissue-vascular damage and     proliferation: transforming growth factor-beta (TGF-β); hypoxia-inducible factor (HIF) and     vascular endothelial growth factor (VEGF). Data will be analyzed following a prospectively     define plan and by intention-to-treat analysis.   "
108892|NCT01860703|"     Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover     study to evaluate the effect of deferiprone on QTc prolongation after administration of a     single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in     healthy volunteers as compared to placebo treatment.   "
108893|NCT01860690|"     The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for     Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that BHCG level     in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According     to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the     trophoblast tissue , and only day 10 is an indicator for treatment success   "
108894|NCT01860677|"     Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in     brain activity.   "
108895|NCT01860664|"     The purpose of this study is to determine the safety and effectiveness of hydrocortisone     ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.   "
109092|NCT01858064|"     The primary aim of this study is to assess the predictability of treatment response to     stimulants in adults with ADHD using functional magnetic resonance      This study will be a six-week, open-label study including adults ranging from age 18-55 with     ADHD.   "
108897|NCT01860638|"     This multicenter, double-blind, placebo-controlled, randomized study will evaluate the     efficacy and safety of the addition of bevacizumab or placebo treatment to lomustine in     second-line treatment and standard of care (SOC) in third-line treatment following disease     progression after first-line treatment in participants with newly diagnosed glioblastoma. All     enrolled participants will receive first-line treatment with radiotherapy, temozolomide, and     bevacizumab. At first disease progression (PD1), eligible participants will be randomized     (1:1) to bevacizumab plus lomustine or placebo plus lomustine for second-line treatment.     After second disease progression (PD2), participants will continue with blinded bevacizumab     or placebo with the addition of an SOC agent for third-line treatment. Following third     disease progression (PD3) and subsequent, blinded bevacizumab or placebo may continue at the     discretion of the investigator, or open-label bevacizumab may be given at the choice of the     participant.   "
108898|NCT01860625|"     Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in     healthy male subjects.   "
108899|NCT01860612|"     The purpose of this study is to evaluate the safety and effectiveness of an artificial iris     prosthesis for the treatment of iris defects.   "
108900|NCT01860599|"     It is well known that diabetes and excessive or high blood sugars causes blood vessel and     blood cell damage. It is also possible, then, that people with pre-diabetes may also start to     have blood vessel and blood cell damage as the blood sugars rise from the normal range into     the diabetic range. In addition to looking at potential damage, the question is whether or     not this damage improves with exercise. This study aims to look at blood vessel and blood     cells in three different ways by 1) looking at how the blood vessel responds to sheer force     (a blood pressure cuff pumped up and then released after a few minutes). This is done by     ultrasound. 2) By looking at blood tests such as blood sugar, cholesterol, and inflammation     and 3) By looking at certain blood cells in the lab, how long they live and the number of     cells left after a certain number of days, and again, if this improves with exercise.   "
108901|NCT01860586|"     The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin) on     the rates of recurrent retinal detachment and scar tissue formation.   "
108902|NCT01860573|"     The purpose of this study is to determine whether providing increased protein to premature     infants in the first week of life allows for better growth during the hospital stay and     improved developmental outcomes by age 2.   "
108903|NCT01860560|"     Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow     Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the     management of apnea / hypopnea index (AHI).   "
108904|NCT01860547|"     The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë     rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on     lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic     diseases.   "
108910|NCT01860469|"     Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will     decrease rates of mesh infection   "
108911|NCT01860456|"     Rationale      The pharmacokinetics of imatinib and nilotinib, two BCR/Abl tyrosine-kinase inhibitors (TKI),     is variable among patients suffering from chronic myeloid leukemia (CML). Transmembrane     transporters may play a pivotal role in interindividual variability in TKI disposition.     Furthermore, minimum plasma concentrations (Cmin) higher than 1 mg/L could be associated with     a higher likelihood of molecular and cytogenetic responses.      Therefore, the TIKlet study is aimed at evaluating any possible correlation among the     pharmacogenetics of transmembrane transporters, imatinib and nilotinib pharmacokinetics and     treatment efficacy/tolerability in CML patients.      1. PATIENTS AND METHODS      1.1. Patients      Patients affected by CML will be enrolled in the TIKLet study after the informed consent will     be signed. The following inclusion criteria will be adopted:        -  patients of both sexes,        -  age between 18 and 80 years,        -  treated with imatinib or nilotinib,        -  included in the follow-up in the Divisions / Units of Hematology involved in the          project,        -  able to give informed consent to trial participation,        -  with a proved compliance with the scheduled treatment.      The administration of other drugs will be allowed, but active pharmacological agents, their     dose and duration of treatment should be known.      Smoking and herbal products will be allowed but they should be recorded. Alterations in liver     and kidney functions, body mass index >28, or any other alteration in physicochemical exams     does not represent exclusion criteria.      1.2. Enrolment and follow-up visits      During enrolment visit, the following activities will take place:        -  patients will be informed about the characteristics, objectives, and procedures of the          study.        -  Patient's consent to study participation will be confirmed by signing the informed          consent form.        -  Assignment of personal alphanumeric code.        -  Collection of main data of the patient within the individual case report form (CRF).        -  Collection of a blood sample (approximately 4 mL). At follow-up visits, a blood sample          (approximately 4 mL) will be collected for therapeutic drug monitoring of drugs and          patients' CRF will be updated. The blood sample and all of the records will be sent to          the Dept. of Clinical and Experimental Medicine, University of Pisa.      1.3. Blood samples      Each tube containing the patient's whole blood, plasma or DNA and used for the execution of     therapeutic monitoring or pharmacogenetic analyses will be identified by a) the patient's     code and b) the date of execution of blood withdrawal.      After centrifugation of the blood sample, the resulting plasma (1.5 mL) will be collected and     stored in an eppendorf tube for the measurement of drug concentrations. During the enrolment     visit, an aliquot of whole blood (0.5 mL) will be collected in a sterile eppendorf tube for     molecular analyses. Both samples will be stored at -20 °C for a maximum of 2 weeks, then they     will be sent to the Dept. of Clinical and Experimental Medicine, University of Pisa.      1.4 Laboratory analyses      The following analyses will be conducted at the Department of Clinical and Experimental     Medicine, University of Pisa and at the Department of Pharmacology, University of Bologna.      Plasma concentrations of drugs (i.e., imatinib and its metabolite, nilotinib) will be     measured by high-performance liquid chromatography systems. Values of plasma concentrations     will be analyzed by a population pharmacokinetic analysis to obtain main pharmacokinetic     parameters (i.e., clearance of the drugs). Those parameters will help to describe in a     quantitative manner drug disposition into every patient.      Furthermore, DNA will be extracted from whole blood and genetic variants (called single     nucleotide polymorphisms) will be investigated in the following genes that code for     transmembrane transporters: ABCB1, ABCG2, hOCT1, OCTN1, OATP1A2.      Finally, response to drugs, in terms of Major Molecular Response (MMR) and Complete     Cytogenetic Response (CCyR), and tolerability will be evaluated. Any possible correlation     among drug disposition, pharmacogenetics and treatment effects will be analyzed.   "
108912|NCT01860443|"     Background: Depression is common in adolescents and it is associated with serious     consequences. In Chile, primary care team has a leading role in the management of depression     in adolescents. Nevertheless, the majority of primary care professionals report not feeling     adequately prepared to take on this responsibility and having difficulties referring patients     to specialists. This situation is particularity complex in regions far away from the central     zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical     expertise.      Purpose: The purpose of this study is to determine whether a telepsychiatry-based     collaborative program is effective to improve the management of depression in adolescents     between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.      Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents.     The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program     will be evaluated.   "
108913|NCT01860430|"     This clinical trial is aimed to establish a recommended starting dose of ipilimumab for a     future efficacy trial when used in combination with intensity modulated radiation therapy     (IMRT) and cetuximab.   "
108914|NCT01860417|"     In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC),     obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease     (DDD). The trial is based in previous results with autologous MSC (Orozco et al.,     Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective,     randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing     Practice (GMP)-compliant expanded bone marrow MSC (MSV, PEI Num. 10-134). The assay consists     of two arms with 12 patients each one. Patients in the experimental arm will be given a     single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be     infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We     shall follow the evolution of pain, disability and quality of life as well as disc fluid     content by Magnetic Resonance Imaging (T2-calibrated).   "
108915|NCT01860404|"     This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory     clinical trial of branched chain amino acids (BCAA's) in the treatment of sports-related     concussion. The aim of the study is to determine whether, compared to placebo treatment,     administration of BCAA's, at one or more doses, after a sports-related concussion improves     neurocognitive recovery at one or more time-periods post concussion.   "
108934|NCT01860157|"     In this study, the investigators will be examining the effects of the deep repetitive     transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 who     have been unable to tolerate or failed to respond to antidepressant medications. The coil was     designed to stimulate deeper regions of the left DLPFC. The investigators propose that active     stimulation with the H1 coil will result in higher remission rates than placebo stimulation     but will have a similar tolerability and safety profile.   "
108935|NCT01860144|"     This observational, multicenter, prospective study will evaluate the use of bevacizumab in     real clinical practice in chinese patients with metastatic colorectal cancer.   "
109111|NCT01857817|"     The purpose of this study is to evaluate the clinical benefit of the co-administration of     propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate     cancer.   "
108916|NCT01860391|"     The aim of the study is to measure salivary fluoride and silver levels up to 7 days     post-treatment.      The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to     use the day before the study and all during the study.      3 participants will have 6 teeth treated (Group A).3 participants will have 28 teeth treated     each on the facial aspect (Group B).      On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in     the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3     times.      On day 0, 10 minutes after the rinsing and spitting, the participant will provide a     unstimulated salivary sample into a universal collection tube until 5 ml are collected. The     tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at     the University of Washington.      On Day 0, Isolation and application of silver fluoride.      The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with     petroleum jelly to provide additional protection.      After application, participant will be given 25 ml of fluoride free water to rinse as in 1     above and water collected. This will be done 10 times.      DAY 1-6 Salivary Collection      Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier     et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry     (EPA 6020a Rev.1 2007) at the University of Washington   "
108917|NCT01860378|"     This study is a small-scale randomized, placebo-controlled factorial trial of two     interventions to increase Tetanus, diphtheria and acellular pertussis (Tdap) immunization     rates among infant caregivers. Specifically, the trial will compare a full cost vs. $5 Tdap     voucher with or without an educational video.   "
108918|NCT01860365|"     In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of     integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS     established the Integrative Oncology Program with the goal of addressing patient concerns and     improving quality of life parameters during chemotherapy and advanced disease. The study     hypothesis is that integrated medicine consultation and treatment provided within the     oncology department may improve patients' concerns and well-being.   "
108919|NCT01860352|"     The purpose of this study is to see what effects the dietary supplement called Omega-3 or     Fish Oil and it has on your colon, if any. Omega-3 (Fish Oil) is available in many forms     (pills, capsules, liquid) in grocery stores, health food/vitamin stores and drug stores and     from eating fish. We would like to learn if different amounts of Fish Oil specifically chosen     for you individually change your colon tissue (large intestine). We hope that Fish Oil may be     useful in the future as something that may help to prevent colon cancer, but we don't have     any research in humans that shows that yet. We have to do this study first to see if Fish Oil     effects the colon. One type of Fish Oil is has been approved by the U.S. Food and Drug     Administration (FDA) to reduce the risk of heart disease. We are going to test a different     Fish Oil supplement made by a company called Nordic Naturals.      The colon lining or mucosa comes in contact with all the undigested things we eat or drink     as it passes out to waste (stool). Animal studies suggest that fish oil may help the colon     lining by reducing colon polyps and therefore colon cancer. We think this happens through     chemical changes in the colon lining and also in the blood. The chemicals that we are looking     at are called fatty acids. We want to see if taking different amounts fish oil chosen for     you changes these chemicals (fatty acids) in your colon or your blood. We will assign you a     personal low dose of fish oil to take for 2 weeks, followed by a high dose, or maximum     dose for 2 weeks. We will calculate your basal Metabolic Rate (BMR) from your height, weight,     age and assess your activity factor. We have a table that then tells us your target low and     high dose. Then, based on your blood samples, we figure out which target dose is the one for     you that will change these chemicals (fatty acids) by about ½ (50%). We will check how well     this process worked by collecting small pieces of colon tissue (biopsies) of the colon before     any fish oil and after all the fish oil is consumed. We will also use blood samples to test     for these fatty acids and a few others. We are going to collect diet information at several     times throughout the study so we can see if the food you eat makes a difference too.      We hope to learn a lot about how fatty acids are metabolized (broken down or used) in the     colon directly in combination with Omega-3 supplements.   "
108943|NCT01860040|"     To determine the rate of pathologic complete responses (pCR) at the time of definitive     surgical resection of non-small cell lung cancer (NSCLC)   "
109057|NCT01858519|"     This is a point prevalence study conducted entirely in the United States (US) to establish     the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in     cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for     pancreatic insufficiency compared with matched (age and region of residence) control patients     with chronic medical conditions unexposed to PERT.   "
108920|NCT01860339|"     Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of     cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat     (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized     as a neurodegenerative disease. However, recent evidence suggests that abnormal brain     development may play an important role in the etiology of HD. Huntingtin (HTT)is expressed     during development and through life. In animal studies, the HTT gene has been shown to be     vital for brain development. This suggests that a mutant form of HTT (gene-expanded or CAG     repeats of 40 and above) would affect normal brain development. In addition, studies in     adults who are gene-expanded for HD, but have not yet manifested the illness, (pre-HD     subjects) have significant changes in the structure of their brain, even up to 20 years     before onset of clinical diagnosis. How far back these changes are evident is unknown. One     possibility is that these brain changes are present throughout life, due to changes in brain     development,though initially associated with only subtle functional abnormalities.      In an effort to better understand the developmental aspects of this brain disease, the     current study proposes to evaluate brain structure and function in children, adolescents, and     young adults (ages 6-18) who are at risk for developing HD - those who have a parent or     grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging     (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white     matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive     tests, physical and neurologic evaluation, behavioral assessment, and quantitative     craniofacial structure assessment. Subjects that are gene-expanded (GE) will be compared to     subjects who are gene non-expanded (GNE) and as well to matched healthy controls. Changes in     brain structure and/or function in the GE group, compared to both GNE and control groups,     would lend support to the notion that this disease has an important developmental component.   "
108921|NCT01860326|"     This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of     single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment     compared to matched healthy subjects with normal liver function.   "
108922|NCT01860313|"     The purpose of this study is to create a web-based interactive educational environment to     train elementary teachers, to identify children and adolescents in need of specialized mental     health care and give them some advises in managing problematic children in class. After the     creation of such an educational environment the psychoeducational project was tested in order     to verify it's effectiveness.   "
108948|NCT01859962|"     This study is designed to provide a preliminary assessment of the safety and effectiveness of     the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the     treatment of chronic hepatitis C virus infection.   "
108949|NCT01859949|"     To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA)     without epiphyseal closing.   "
108923|NCT01860300|"     This study is an extension of the European Multicentre Tics In Children Studies (EMTICS)     COURSE study for which a separate study protocol exists; Aim of this clinical trial is to     study the efficacy of treatment with antibiotics in reducing severity of tics and associated     neuropsychiatric symptoms in patients with a tic disorder colonised by GAS.      Primary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation compared     to placebo is associated with a larger reduction of tic and associated neuropsychiatric     symptoms in the short-term (1 month) in patients with a tic disorder colonised by GAS.      Secondary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation is     superior to placebo in the long-term (1 year) reduction of tic and associated     neuropsychiatric symptoms in patients with a tic disorder colonized by GAS.      Patients affected by a chronic tic disorder followed in the EMTICS- Longitudinal Course Study     that show a positive culture for GAS at any microbiological examination during their     follow-up will be considered eligible for the treatment trial.      Patients showing GAS positivity will be invited to participate in the clinical trial.      The patients enrolled will be randomly assigned to antibiotic or placebo in a 1:1 ratio.      All participating patients will undergo a microbiological, serological and clinical     assessment 1 month after the date of entering in the treatment trial (i.e. around 20 days     after the end of treatment). Then, the patients will be followed with clinical, laboratory     and microbiological assessments every four months for 1 year.      Patients will be deblinded at the end of the treatment trial follow-up (1 year after the     recruitment).      Patients who will develop a true GAS infection or who otherwise need to be prescribed     antibiotics for any clinical reason during the follow-up will be withdrawn from the study and     immediately deblinded. Data of such patients would, however, remain part of the study     analyses, following the intention-to-treat principle.   "
108924|NCT01860287|"     In this study, the investigators will examine the effects of buprenorphine, as compared to     placebo, upon physiological, subjective, and hormonal responses to a stressful speech task     and a non-stressful control task in healthy adults. There is strong evidence in support of     the role of endogenous opioids and opiates in mediating social behavior in humans and other     animals, and particularly, in social distress. Recently it has been shown that buprenorphine,     a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions     in humans. Here, the investigators propose to further explore the role of the opioid system     in mediating stress responses in humans through the use of buprenorphine. The investigators     hypothesize that buprenorphine with reduce both physiological and subjective measures of     stress.   "
108925|NCT01860274|"     The study hypothesis is that a meshed conduit made of safen vein allows a better patency at     mid-long term than a safen vein alone.      To test this hypothesis the investigators plan a prospective, randomized study, comparing     grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will     be performed one year after the operation.   "
108926|NCT01860261|"     This pilot study will test the feasibility and acceptability of a 12 week combined aerobic     and strength training intervention among persons with HIV who are age 50 or older and do not     exercise frequently, and its preliminary effects on aging-related outcomes . The study uses     an randomized, controlled trial design and is intended to lead to a larger clinical trial     with long-term follow-up. The intervention incorporates small group instruction from a     trainer, a small wearable accelerometer to provide accurate data on physical activity, and     real-time feedback to participants about exercise levels. The primary outcome measure will be     changes in fitness, measured as change in maximal oxygen consumption (VO2 max). The control     group will receive a comparable exercise intervention after they complete 12 weeks of     observation.   "
108927|NCT01860248|"     This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed     with vapocoolant spray in comparison to placebo.   "
108928|NCT01860235|"     Injectable anesthesics previous to subgingival scaling and root planing (SRP) presents some     disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening     of adjacent tissues. This study will compare the intrapocket anesthetic effectiveness of a     skin topical anesthesic EMLA with intrapocket 2% benzocaine, intrapocket placebo and     injectable anaesthesia for SRP in a Split-mouth, double-blind, clinical trial study.   "
108929|NCT01860222|"     The aim of this study is to compare the operative complication and short-/long-term     therapeutic effects of percutaneous local ablative therapy (PLAT) versus surgical     resection(SR) on small hepatocellular carcinoma(HCC) patients with clinically significant     portal hypertension(CSPH) so as to lend clinical and theoretical basis of the therapeutic     schemes for the disease.   "
108930|NCT01860209|"     The purpose of this study is to investigate the effect of decreasing fluid overload by     hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic     kidney disease on intermittent hemodialysis. It aims further to investigate the relationship     between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.   "
108931|NCT01860196|"     This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical     dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind,     Randomized, Clinical trial.   "
142764|NCT01415804|"     The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis     versus medical management in patients with dissection of the thoracic aorta.   "
108932|NCT01860183|"     Development of chronic changes (scarring) in transplanted kidney tissue is a major cause of     long-term kidney function deterioration and ultimately graft loss. It results from both     immunologic and non-immunologic mechanisms. Mycophenolate mofetil (MMF) is immunosuppressive     drug used for prevention of rejection after kidney transplant, usually in combination with a     calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. Besides     immunosuppression, MMF may also have direct antifibrotic properties. Tacrolimus has potent     immunosuppressive effects and is the cornerstone of contemporary posttransplant     immunosuppressive therapy in kidney recipients. However, it is also nephrotoxic. The     hypothesis of the present study is that in the setting of similar net immunosuppression,     higher dose of MMF (3 g daily) will result in slower progression of kidney fibrosis during     first year posttransplant as compared to MMF 2 g daily. To test this hypothesis, the present     study will randomly assign low immunological risk kidney transplant recipients to either 2g     or 3 g MMF daily, in combination with tacrolimus, with, or without maintenance steroids. All     patients will have kidney biopsy at implantation and at 12 months after transplantation. Main     outcome will be 1-year change in chronic kidney histology (interstitial fibrosis) assessed by     protocol biopsy.   "
108933|NCT01860170|"     The purpose of this study is to determine if Bortezomib, known commercially as Velcade is     safe and tolerated at different dose levels (amounts) with high dose Cyclophosphamide to be     used as graft versus host disease prevention after reduced-intensity allogeneic hematopoietic     stem cell transplantation.   "
109016|NCT01859052|"     The purpose of this study is to look at two different diets (a low carbohydrate diet and a     low fat diet) for migraine prevention in overweight or obese persons with migraine. The     overall aim is to test the theory that diet will improve migraine frequency and that such     improvements will be associated with favorable changes in body weight, inflammation, and     heart health.   "
108936|NCT01860131|"     Extreme obesity is present in 9% of the Canadian population. Extremely obese people have a     high chance of developing health problems and dying early. Our national guidelines recommend     that extremely obese individuals receive multidisciplinary treatment, meaning that a number     of specialized care providers should be available to help administer obesity treatments to     these patients.      The investigators oversee a large obesity program called the Weight Wise Obesity Program,     which delivers multidisciplinary care at 5 sites in Alberta, Canada (Edmonton, Calgary, Grand     Prairie, Medicine Hat, Red Deer). Wait times to enter the Weight Wise clinics range from a     few months to three years depending on the site in Alberta. The investigators performed a     survey of the patients on the wait list in Edmonton and discovered that they self- report     extremely poor health and feel that the long wait times are partly responsible for this poor     health. To try to support these patients as they wait for multidisciplinary care, the     investigators designed a group based self-management intervention, consisting of Weight Wise     Community Modules. Patients attend this program over three months to receive weight     management education (diet, exercise, stress management, coping strategies).A web-based     version of the modules is also available.      The investigators wish to determine if these modules delivered to patients prior to entering     the clinic help to reduce weight, improve quality of life in the wait listed patients and     also to see if going through the modules helps patients to be more ready for weight     management when they reach the Weight Wise clinic. The investigators also wish to examine     whether or not these modules are cost effective. If these modules are not useful, a more     effective way to support wait listed patients will be sought.   "
108937|NCT01860118|"     This proposal seeks to 1) determine whether there are biomarkers associated with Parkinson's     disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients     versus controls, and 2) to determine if LRRK2 expression and/or phosphorylation are     significantly lowered in the exosomes of individuals treated with the potent LRRK2 kinase     inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target     effects for future LRRK2 inhibitor clinical trials.   "
108938|NCT01860105|"     Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs),     this study, to be conducted in approximately 36 NHVs, will provide pertinent information in     determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12     receptor inhibition effects and in selection of doses that match the antiplatelet effects of     300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK),     safety and tolerability of single doses of MDCO-157.   "
108939|NCT01860092|"     This post-approval study is being implemented to monitor the use of Argus II System in a     larger US population than available within pre-approval studies. An attempt will be made to     include all eligible and willing subjects implanted with Argus II System in the United     States.      Safety data will be monitored to ensure continued acceptability of risks to study subjects.     The utility (i.e. visual function and functional vision) and reliability of Argus II System     will also be evaluated.      There is no study hypothesis.   "
108940|NCT01860079|"     -  When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at          a high-volume centre, it is the optimal approach for ST elevation myocardial infarction          (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition          for when to discharge and which patient to discharge.        -  An early discharge strategy may be desired by all parties (financial health care          provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.        -  The main goal in our study is to test the hypothesis that an early discharge strategy          within 48-56 hours in patients with successful PPCI is as safe as in those patients who          stay longer (96-120 hours) as of a standard procedure.   "
108941|NCT01860066|"     Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in     patients with moderate to severe airflow limitation.   "
108942|NCT01860053|"     The purpose of this study is to reduce problematic vomiting and associated gastrointestinal     symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention     will yield greater reductions in vomiting and associated symptoms compared to our control     condition.   "
108944|NCT01860027|"     The mechanism of the eye movement anomalies seen in dyslexic patients is not well defined.     Some optometrists use observational eye movement tests as screening devices for dyslexia and     advocate eye movement therapy as a treatment option for dyslexia. The reliability of the     clinical eye movement tests and the efficacy of the eye movement therapies have not been     determined.      Saccades are the fast eye movements that move our eyes from one word to the next when we     read. The eye movement recordings from patients diagnosed with reading disorders, extra     ocular muscle imbalances and control patients (no learning disability or eye movement     disorder) will be analyzed and compared. The sensitivity and specificity of detecting reading     disorders will be determined for the Visagraph III and the Readalyzer. Although these     clinical tests are frequently used to diagnose saccadic inaccuracies and diagnose dyslexia in     school aged children, the validity of these clinical screening tests has not been determined.   "
108945|NCT01860014|"     The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs     mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who     often have a PDA and have received surfactant. Although not clear, the cause of PH is thought     to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right     shunting across a patent ductus arteriosus and an increase in pulmonary blood flow.     Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising     results in treating PH.In this study we aimed to evaluate the effect of two different natural     surfactants in neonates with pulmonary hemorrhage.   "
108946|NCT01860001|"     The aim of this study is to define the incidence and nature of acidosis after major surgery     using Figge's equations to directly measure acidosis. This study will also aim to compare the     ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to     identify the presence of tissue acids in this population. The incidence of postoperative     ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of     care urinalysis.   "
108947|NCT01859988|"     To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult     participants with moderate-to-severe atopic dermatitis (AD).   "
108950|NCT01859936|"     The study is a prospective randomised multicenter trial assessing the additional value of     breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will     preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the     number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies?     Will preoperative breast MRI be cost effective?   "
108951|NCT01859923|"     The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and     efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen     of other anti-tuberculosis drugs in pediatric patients who completed Trial 242-12-232.   "
108952|NCT01859910|"     To investigate whether compression of the lid margin increase microbial contamination risk of     patients undergoing cataract surgery   "
108953|NCT01859897|"     The objective of this five-year prospective observational follow-up study is to examine the     additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of     cardiovascular events in high-risk patients.   "
108954|NCT01859884|"     The objective of this study is to evaluate kidney transplant candidates' comprehension about     increased risk donor kidneys necessary for informed consent. We have developed a web-based     tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to     current informed consent processes. We will then compare the effectiveness of the current     informed consent processes supplemented by Inform Me, with the current consent processes     alone for kidney transplant.   "
108955|NCT01859871|"     The purpose of this study is to increase understanding about living kidney donation (LKD)     among Hispanic/Latino patients and public by increasing knowledge and positive attitudes     about LKD. Improving Hispanics' understanding about LKD will ensure that Hispanic patients     and public are fully informed of the treatment options for End Stage Kidney Disease.   "
108956|NCT01859858|"     Curcumin is an extract of the tumeric root that has been shown to have anti-tumor properties     in laboratory studies. Curcumin, and its parent spice, turmeric (curcuma longa), are the 4th     most commonly purchased dietary supplement in the U.S. Many cancer patients take curcumin     during their treatment for cancer because of the purported health benefits.      This research study is designed to learn more about the safety, pharmacokinetics and     effectiveness of irinotecan when given in combination with curcumin in patients with     metastatic colorectal cancer. The study of how the body absorbs, processes and eliminates     drugs is called pharmacokinetics (PK). One of the main purposes of this study is to better     understand the interaction between curcumin and irinotecan by measuring levels of irinotecan     in the blood (ie. measure irinotecan PK) when a patient also takes curcumin. Information     collected from this study could result in improved dosing guidelines and lead to more     effective treatment of your cancer with less toxicity.   "
108957|NCT01859845|"     The specific aim of this study is to determine if interactive touchscreen-based learning with     deliberate practice modules can enhance the retention of life-saving medical skills when     incorporated into medical training curricula. We will analyze the retention and confidence of     screening skills by comparing outcomes on pretest and posttest in each arm.   "
108969|NCT01859689|"     This phase II trial studies how well internal radiation therapy works in treating patients     with low-risk prostate cancer. Internal radiation uses radioactive material placed directly     into or near a tumor to kill tumor cells.   "
108970|NCT01859663|"     The purpose of the study is to identify lifestyle factors associated with PCOS and understand     how diet and activity levels impact features of PCOS. The secondary aim is to examine     psychosocial factors (e.g., health beliefs) of women with PCOS.   "
109075|NCT01858285|"     Investigators at Boston Children's Hospital are conducting research in order to better     understand the genetic factors which may contribute to disorders related to epilepsy. These     findings may help explain the broad spectrum of clinical characteristics and outcomes seen in     people with epilepsy.   "
108958|NCT01859832|"     Patients undergoing renal transplantation at London Health Sciences Centre, University     Hospital and who are participating in the study A Comparison of Effects of Standard Dose vs     Low Dose Advagraf with IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without     ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune     Response will be evaluated with the ImmuKnow Assay to assess the ability of this assay to     predict underimmunosuppression (rejection) or overimmunosuppression determined by this test     and to determine retrospectively whether decision making utilizing this novel assay would     have improved outcomes over standard techniques.      This study is designed to evaluate an in vitro assay (Cylex®ImmuKnow Assay) for the     measurement of cell-mediated immune response in renal transplant patients receiving     immunosuppressive therapy. This assay measures ATP as an activation response of CD4+ cells to     stimulation with phytohemagglutinin (PHA) in whole blood samples as a reflection of the     immune system of the patient at any point in therapy. The natural history of the immune     status of the renal transplant recipient as reflected by the ImmuKnow assay will be     determined at specific time points of interest including: pre and post transplant, as an     adjunct to therapeutic drug monitoring, and pre and post infectious or rejection episode.     Analysis of the results of the assay at these time points will allow us to retrospectively     study the effects of routine immunosuppressive agent modulation on immune function, and its     subsequent effects in times of renal allograft insult.   "
108959|NCT01859819|"     To safely reduce the burden of therapy in children, adolescents and young adults with mature     B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT     Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline     (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy     backbone (Immunochemotherapy).   "
108960|NCT01859806|"     Pancreaticoduodenectomy (PD)is the treatment of choice for patients with periampullary tumour     (benign or malignant). In the recent years, the mortality rate of PD has decreased to 5% in     many centers. However, pancreatic fistula (POPF) still occurs in 5 % to 40% of patients after     PD. The hypothesis that isolated Roux loop PJ with isolated pancreatic drainage decrease the     incidence of PF and severity with preservation of pancreatic function.      So the investigators compare isolated Roux Loop Pancreaticojejunostomy (PJ) Versus     Pancreaticogastrostomy (PG) as regards incidence of POPF, severity of POPF and functional     outcome.   "
132960|NCT01544881|"     This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response     (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.   "
108961|NCT01859793|"     The study is being performed to determine whether sitagliptin, a dipeptidyl peptidase-4     inhibitor, both acutely and chronically improves blood vessel function. Patients with type 2     diabetes who are on metformin will be enrolled in this study for up to 22 weeks in this     double blinded cross over study where they will receive a sitagliptin pill once a day for 8     weeks and during a separate 8 weeks receive a matching placebo pill. The treatment periods     are divided by a 4 week period. Blood vessel function will be measured by ultrasound before     and after a single dose of sitagliptin and placebo, as well as after 8 weeks of treatment     with each. Blood will also be taken to measure blood markers of inflammation at each time the     ultrasounds are performed.   "
108962|NCT01859780|"     Unintentional poisonings of children continues to be a major issue in the US. According to a     study conducted by Cincinnati Children's Hospital Medical Centers, during the period from     2001-2008, emergency room visits for children less than 5 rose 28% as the result of     pharmaceutical products. The authors note, the problem of pediatric medication poisoning is     getting worse, not better.      Child resistant closures have been required on most medications sold in the US since the     early 1970s. However, most designs attempt to thwart children through purely physical means     (e.g. simultaneous dissimilar motion or opening using sequential tasks). Few, if any designs,     have utilized perception and cognition as a way to enhance child resistance.      The investigators propose utilizing visual illusions in spaces distinct from the opening     mechanism of prescription packages as a means of enhancing child resistance. In this project,     visual illusion images are applied to both vials and wallet blisters in order to attract     children's interest and prolong the time before opening.      During Stage I, the investigators will determine if the visual distractor attracts attention     when samples are displayed in a storage rack. During Stage II, the investigators will test     the effect of visual distractors on child resistance as measured by successful openings and     time to open.   "
108963|NCT01859767|"     This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD     patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of     MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to     detect ß amyloid deposition in the brain of AD research participants and young healthy male     subjects. All study procedures will be conducted at Molecular NeuroImaging (MNI) in New     Haven, CT. Approximately 3 patients with AD and 3 young male HVs will be recruited to     participate in this study. HVs will be screened to ensure that there is no evidence of     cognitive decline or significant neurological deficit.      All eligible subjects will be required to visit the study center on at least 2 occasions:        1. for one or more screening visits which should include a history and physical          examination, laboratory and extensive neuro-psychological testing and MRI brain          scanning. AD subjects will also undergo Amyvid PET imaging as part of the Screening          Visit.        2. on one day for baseline examinations and MNI-672 administration and subsequent SPECT          scanning- followed by safety measures   "
108964|NCT01859754|"     Study Design:      This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug     reactions between Octagam 5% and other marketed IVIG infusion treatments.   "
108965|NCT01859741|"     The study consists of a Phase1b lead-in portion to determine the MTD of OMP-59R5 in     combination with EP for 6 cycles followed a Phase 2, multicenter, randomized,     placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with     EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in     subjects receiving first-line therapy for extensive stage small cell lung cancer.   "
108966|NCT01859728|"     To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment     of biliary tract cancer.   "
108967|NCT01859715|"     This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of     oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.   "
108968|NCT01859702|"     The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing     with a combination drug Vigadexa preoperatively in cataract patients.   "
108971|NCT01859650|"     The University of Sheffield is one of the leading centres in the world for basic and     translational research with inhaled gas MRI, which provides lung images with unprecedented     spatial and temporal resolution. Our previous work demonstrated that inhaled gas MRI can     provide significant clinical information for lung cancer radiotherapy planning and     post-treatment evaluation. Building upon this unique experience, a multidisciplinary team     will conduct an inhaled gas and proton lung MRI study that will address two of the major     clinical problems faced by lung cancer patients treated with radiotherapy.        1. Normal lung tissue is often damaged by the curative radiation dose. The investigators          hypothesise that regional ventilation-perfusion lung function imaging with inhaled gas          and proton MRI before and after treatment will help to lower the risk of          radiation-induced lung injury and help to detect such damage at an early stage.        2. Identification of the extent of cancerous tissue is error-prone when planning treatment          from CT images alone. The investigators hypothesise that advanced proton MRI techniques          will improve the identification of tumour volume, which is critical to successfully          targeting the radiation dose.      To achieve these goals, image acquisition and image processing methods will be tested with a     study of 20 patients. Results from this study will make an important contribution to     improving the treatment of lung disease which is one of the key research priorities of the     NHS.   "
108972|NCT01859637|"     Purpose of the study is to investigate the safety, immunogenicity and the efficacy of     Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed     with severe chronic neutropenia.   "
108973|NCT01859624|"     Albuterol is a drug approved by the US Food and Drug Administration (FDA) for treating     breathing problems such as asthma. Studies have shown that albuterol may be beneficial in     improving muscle function in people with late-onset Pompe disease. The purpose of this study     is to evaluate whether albuterol is safe and effective for improving muscle function in     people with late-onset Pompe disease, whether or not they are receiving enzyme replacement     therapy (ERT). For this study, albuterol is considered an investigational drug. The word     investigational means albuterol is not approved by the FDA for individuals with late-onset     Pompe disease.   "
109139|NCT01857440|"     This study is designed to investigate whether the pupil response to slowly flashing colored     lights is significantly altered in patients with glaucoma, as compared to a control group of     subjects without glaucoma.   "
108974|NCT01859611|"     The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source,     the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple     treatments. The primary endpoint is observation of changes to the surface by visual and     photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort     of the treatment and the measurement of adverse events.   "
108975|NCT01859598|"     The scientific use of basal insulin is of great help to individuals and the government.     However, there are few studies to investigate the real world use, effect, safety and     influence factors of basal insulin in China. This study is to evaluate the use of first basal     insulin in China patients with type 2 diabetes with inadequate glycemic control on oral     antidiabetic agents (OADs) from the naturalistic clinical practice.   "
108976|NCT01859585|"     The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a     preemptive analgesia in patients undergoing lumbar spinal fusion.   "
108977|NCT01859572|"     The rationale for this study is to facilitate future Phase II/III clinical trials and improve     outcome for patients suffering residual disability after an ischaemic stroke. Main study     objectives are to document and better define the prognostic characteristics of residual     disability in patients following an ischaemic stroke, to inform the design of small efficient     Phase II studies when screening potentially efficacious interventions for signals of activity     which merit further development and to establish a pool of patients who may be approached to     participate in future clinical trials in the ischaemic stroke setting.   "
108978|NCT01859559|"     The primary objective of this randomized controlled trial (RCT) is to compare the success     rate of obtaining peripheral vascular access with ultrasound guidance versus the traditional,     landmark approach among patients with varying degrees of intravenous access difficulty. In     addition to comparing overall initial success rates of the two methods, we will also compare     the success rates by degree of intravenous access difficulty (3 main subject subgroups) and     by operator experience (approximately 20 emergency department technicians).      The main hypothesis is that the initial success rate will be significantly higher (5% or     greater) for ultrasound guided peripheral intravenous access compared to landmark approach     among patients who are judged to have difficult intravenous access but no significant     difference (i.e. < 5%) among patients judged to have easy intravenous access.   "
108979|NCT01859546|"     Vaccines are one of the best public health tools available to achieve the Millennium     Development Goal (MDG) # 4 of decreasing child mortality. A major reason for poor childhood     vaccine coverage is the lack of awareness among parents regarding the need for immunization     in children, and the importance of completing the entire series of vaccines. This result in     significant drop-out between vaccines delivered at birth and later in the infancy period. New     innovative methods involving technologies are needed to be employed to increase the vaccine     coverage. This study is being conducted in Karachi, Pakistan and main study objective is      • To assess the effectiveness of SMS reminders on cell phones in improving the compliance of     subsequent visits for routine immunization for children.   "
108980|NCT01859533|"     Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via     Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the     duration and complication of TTN.   "
108981|NCT01859520|"     Sperms are prepared by sperm washing techniques before used in assisted reproductive     technologies. Most commonly used sperm preparation methods are the swim up and the density     gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to     the success in assisted reproduction techniques. Sperm preparation methods may theoretically     cause damage to sperm DNA. Therefore it is important to select the optimum method of sperm     preparation causing least sperm DNA damage. Aim of our study is to investigate and compare     the effect two different sperm preparation techniques on DNA fragmentation.   "
109013|NCT01859091|"     The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for     non-invasive reduction of submental fat.   "
109085|NCT01858155|"     This study will evaluate dose escalation of melatonin in pediatric oncology patients with     relapsed solid tumors. The purpose of this study is to determine the safety of melatonin at a     dose up to 20 mg daily, as well as to determine the maximum tolerated dose of melatonin.   "
108982|NCT01859507|"     During the first visit, the couple will be acquainted with their condition. This will include     the epidemiology of their condition, some sex education tips, as well as the therapeutic     modalities available. This is followed by short description of the protocol. In the procedure     room, each patient will be examined to determine the degree of vaginismus and classify her     condition according to Lemont's classification as modified by Pacik, from 1 to 5. In the same     or subsequent sessions, surface anesthesia of the area of injection followed by ice packs is     used before the BOTOX is injected into the muscle.   "
108983|NCT01859494|"     The purpose of this study was to determine if untrained subjects who have diabetes can     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose     results.   "
108984|NCT01859481|"     Evaluation of headache response at 2 hours for active treated attacks for increasing dose.   "
108985|NCT01859468|"     Amorphical has a strong basis to believe that the Amorphous Calcium Carbonate (ACC) product     has an effect on active mineralization during bone remodelling hence, it has a potential to     accelerate fracture healing process. The active mineralization can most probably be     attributed to the mineral component of this substance.      The distal radius fracture was chosen as the model to test the effects of ACC treatment     because it includes both trabecular and cortical bone, is accessible for radiographs, has     little soft tissue that can distort the radiograph, and is amenable to multiple functional     endpoints.      Primary objective:      To assess the efficacy of treatment with calcium from ACC compared to placebo on radiographic     healing time in subjects with distal radius fractures.      Secondary objectives:        -  To evaluate the effect of ACC compared to placebo on the improvement in wrist functional          outcome following distal radius fracture.        -  To evaluate the safety profile of ACC in this population   "
108986|NCT01859455|"     This study is designed to investigate the safety, tolerability, pharmacokinetics and     pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications     and in healthy volunteers.   "
133370|NCT01539226|"     This is a double-blind, randomised, placebo-controlled study to assess the safety and     efficacy of a silicone elastomer vaginal matrix ring.   "
108987|NCT01859442|"     The present study is a randomised control trial investigating the effects of a short six week     exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy     prior to elective rectal cancer surgery.      Twelve patients will be randomised (1:1) to an intervention and a control group. The patients     randomized to the intervention group will attend a total of 18 tailored exercise sessions     (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy treatment.     Where possible the exercise training sessions will be arranged to fit in with other     appointments at the hospital. Patients randomized to the control group will be unsupervised.     They will only attend an extra 3 sessions were a cardiopulmonary exercise test and VO2     Kinetics test will be performed. Patients will also be invited to attend 3 health related     quality of life interviews at week 0, 3 and 6 during their exercise programme. These     appointments will be directly before or after their exercise sessions to minimise hospital     attendence.      Following surgery only routine clinically relevant observational data will be collected.     These data will relate to hospital length of stay, the level of care required following     surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this     information can be accessed from patient notes and on the electronic patient records system.      This is a subgroup RCT of patients in a larger interventional trial (6 control and 6 exercise     intervention patients) will be asked to consent separately for the the 31-Phosphorus Magnetic     Resonance Spectroscopy (31P MRS) scans and the blood samples.      HYPOTHESIS        1. Interval exercise training will maintain or improve fitness (measured by anaerobic          threshold) in patients undergoing neoadjuvant chemoradiotherapy.        2. Interval exercise training is safe and feasible in patients undergoing neoadjuvant          chemoradiotherapy awaiting rectal cancer resection.        3. Interval exercise training will improve other measures of physical fitness measured in          the CPET and the oxygen uptake kinetics test.        4. Interval exercise training will improve quality of life in patients undergoing          neoadjuvant chemoradiotherapy.        5. Improvements in physical fitness will reduce postoperative complications following major          rectal cancer surgery.        6. Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during          neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise          training program?        7. Can we find an optimal time for surgery when fitness and cancer downstaging are at their          best?      HYPOTHESIS for Mechanism Pilot Study        1. To explore the exponential rate constant of post-exercise phosphocreatine recovery.        2. To explore the alteration in cellular and mitochondrial energetics eg. Change in          mitochondrial numbers, change in mitochondrial activity and respiration.   "
108988|NCT01859429|"     The study will examine whether the provision of psychosocial support services for cancer     patients in acute care can be optimized by the use of a structured combination of screening     procedures with physician interviews and structured patient pathways.      There is strong evidence that a third of all cancer patients in acute care are suffering from     mental health conditions and that a third expresses the need for professional     psycho-oncological support.      However, physicians and nurses do not always identify these patients in need for support.     Screening questionnaires are significantly better to identify distressed patients however the     use of screenings alone does not necessarily improve the patients' emotional well-being.      Purpose of this study is to evaluate a psychosocial stepped care model which aims to decrease     the patients' distress.   "
108989|NCT01859416|"     Although oral nutritional supplements (ONS) are known to be effective to treat malnutrition     in older persons, evidence from nursing home populations including demented residents is     rare, especially with regard to functionality and well-being. A known barrier for ONS use     among older persons is the volume that needs to be consumed, resulting in low compliance and     thus reduced effectiveness.      Thus, this study aimed to investigate the effects of a new, low volume, energy- and     nutrient-dense ONS on nutritional status, functionality and quality of life of nursing home     residents with malnutrition or at risk of malnutrition.      In 6 nursing homes in Nuremberg and Fuerth, Germany, a standardized screening was performed     to identify all residents with malnutrition or at risk of malnutrition who might possibly     benefit from nutritional intervention. All subjects with either a Mini Nutritional Assessment     (MNA®) score below 24 points, BMI ≤22 kg/m², a low food intake according to the nurses'     perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months, respectively, were     invited to participate and asked for informed consent.      Eligible residents with informed consent were randomly assigned to the intervention group     (IG) which received two bottles of the ONS per day (250 mL, 600 kcal) in addition to usual     nutritional care or to the control group (CG) which received usual nutritional care only.      Assessment of nutritional parameters included body weight, BMI, arm- and calf-circumference     and Mini Nutritional Assessment (MNA). Cognitive status, depression, activities of daily     living, handgrip strength, gait speed and quality of life were examined using standardized     instruments and protocols. All measurements and tests were performed at baseline, after 12     and 24 weeks.      Compliance and tolerance were documented daily by nursing staff and regularly controlled by     the study team.      Statistical analysis was performed following the intention-to-treat (ITT) approach including     all residents originally assigned to either the IG or CG unless residents died during the     study. A sample size calculation was performed with body weight as the primary outcome     parameter (0.8 power to detect a significant difference p<0.05, two-sided) based on an     estimated mean body weight 55 kg and a mean difference in body weight between the groups     after 12 weeks of 1.5±2.2 kg comparable to results previously observed in this population. To     detect a significant difference between IG and CG, 35 subjects were needed for each group.     While sample size calculation aimed at ensuring adequate power to detect meaningful     differences, the actual statistical analysis was of exploratory nature.   "
108990|NCT01859403|"     This study aims to determine if providing genomic information to veterans can help them lose     weight compared to usual care.   "
109014|NCT01859078|"     The purpose of this study is to determine the effect of baricitinib on the levels of digoxin     in the blood stream and how long it takes the body to remove digoxin. This study will also     look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in     healthy participants. This study will last approximately 3-4 weeks.   "
110854|NCT01834963|"     To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy,     interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with     hepatocellular carcinoma with portal vein tumor thrombus.   "
108991|NCT01859390|"     The purpose of this study will be to evaluate the effects of a modified formulation of     AquADEKs (AquADEKs-2) on markers of inflammation, antioxidant levels and oxidative stress.      Cystic Fibrosis (CF) is a disease that affects the organs in the body such as the lungs. Some     of the damage to the lungs of CF patients may be caused by something called     oxidant/antioxidant imbalance and oxidative stress.      Oxidation in the body is kind of what happens to an apple when it turns brown after being     cut. And, just as a squeeze of lemon juice stops the oxidation of an apple, antioxidants can     stop the rusting (or damage) inside our bodies by unstable oxygen molecules called free     radicals. Free radicals can help fight off bacteria and viruses but too many of them do     damage instead. Our bodies need antioxidants to keep things in balance so we have the right     amount of free radicals.      Many CF patients also have trouble digesting food and absorbing nutrients like vitamins. Many     of the vitamins we rely on are antioxidants, like vitamins A, D, E, K and beta-carotene. In     some people with CF, even though they take multivitamins and pancreatic enzymes, they still     have low amounts of antioxidants. The investigators are looking to see if taking more     vitamins and antioxidants will help CF patients.      AquADEKs-2 is an investigational new drug (a drug that has not received approval by the Food     and Drug Administration [FDA]). This research study is being done with the AquADEKs-2     compared to a control multivitamin. The study drug, AquADEKs-2 contains standard amounts of     fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements     plus several antioxidants including beta-carotene, mixed tocopherols (different forms of     vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and     the minerals zinc and selenium. The control multivitamin contains standard amounts of     vitamins A, B, D, E, and K without additional antioxidant supplementation.   "
108992|NCT01859377|"     The purpose of this study is to evaluate the systemic exposure to ibuprofen after single     oromucosal administration of the test product V0498 and single oral administration of a     reference product.   "
109061|NCT01858467|"     The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for     positive pressure ventilation and good first attempt insertion rate of 98% in low-risk     patients undergoing Caesarean section. It has a double aperture design that facilitates the     introduction of an orogastric tube to aspirate gastric contents. The current practice is to     use endotracheal intubation with rapid sequence induction in general anaesthesia for     Caesarean section.      The primary study hypothesis is the first attempt insertion success rate of SLMA and     endotracheal intubation are equivalent with a difference of less than 3%.   "
108993|NCT01859364|"     Background:      - The success rate for those who attempt to quit using tobacco products is only about 5     percent. Many people who try to quit do so without seeking professional help. Several kinds     of nicotine replacement therapy (NRT) are available without a prescription. However,     prescription drugs and mental health counseling can also help people stop using tobacco.     Combining NRT and/or medication with counseling can increase success rates. Researchers want     to study what kinds of tobacco cessation treatments are most successful. This may help     develop better treatments and determine who will respond best to them.      Objectives:        -  To provide treatment for tobacco use.        -  To identify factors that affect how well people respond to treatment.      Eligibility:      - Individuals at least 18 years of age who are trying to stop using tobacco products.      Design:        -  This study will last up to 1 year. Treatment may last up to 36 weeks. Treatment may          include counseling, NRT (patches and/or nicotine lozenges), or prescription medication          (varenicline or bupropion). Treatment will be determined by a study doctor.        -  Participants will also have three study visits at 4, 6, and 12 months after starting          treatment. Each visit may take up to 2 hours. At the study visits, participants will          have different kinds of tests. They will provide blood and urine samples, and have          carbon monoxide breath tests. They will also fill out forms about mood and tobacco          cravings.        -  During treatment, participants will have clinic visits once or twice a week for          counseling and to monitor tobacco use and withdrawal symptoms. Counseling sessions will          work on dealing with tobacco cravings. Each visit may take up to 90 minutes.   "
108994|NCT01859351|"     The purpose of this study is to test the safety of escalating doses of the novel PI3K     inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets     mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these     two novel compounds could provide targeted inhibition of both pathways to block tumour     growth.   "
108995|NCT01859338|"     This clinical trial studies magnetic resonance imaging (MRI), cone beam computed tomography     (CT), and fan beam CT in detecting soft tissue in patients with prostate and lung cancer     undergoing radiation therapy. Comparing results of diagnostic procedures done before and     during radiation therapy may help doctors predict a patient's response to treatment and help     plan the best treatment.   "
108996|NCT01859325|"     Background:      - In most people who have human immunodeficiency virus (HIV), the immune system cannot     control or cure the infection. Antiretroviral therapy drugs can keep the amount of HIV virus     low for a long time. However, this treatment does not remove the virus from the body. In the     vast majority of patients antiretroviral therapy also will not protect the body from the     virus once treatment stops. Researchers want to see if therapeutic vaccination can help     people with HIV. Therapeutic vaccination means giving vaccines to treat an infection that     someone already has (HIV, in this case). It may help the body's immune system attack the     infection. This study will look at different measures of HIV infection after receiving either     therapeutic vaccination or a placebo.      Objectives:      - To see whether therapeutic vaccination is safe and can affect how the body responds to HIV     infection.      Eligibility:      - Individuals between 18 and 65 years of age who have HIV and are taking antiretroviral     therapy drugs.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  During the screening visit and throughout the study until week 56, participants will          continue to take their HIV medications.        -  Participants will be divided into two groups. One group will have the study vaccines.          The other will have a placebo.        -  The first study vaccine or placebo will be given in weeks 4, 12, and 36. The second          study vaccine or the placebo will be given in weeks 24 and 48. Blood samples and other          tests will be given at each visit.        -  After the study visit at week 56, participants will stop their HIV medications until          week 72. From weeks 58 through 72, they will come in every 2 weeks for study visits;          each visit will take about 1 hour to complete. These visits will look at the body s          response to the vaccines and their HIV viral load. After week 72, participants will          re-start their HIV medications.        -  There will be follow-up study visits from weeks 76 to 96, with blood tests and other          studies.   "
108997|NCT01859312|"     Background:        -  Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The          adrenal gland is located in the abdomen and produces small amounts of hormones such as          cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect          the body, and maintain good health, especially during development. People with CAH do          not make enough cortisol and aldosterone, and make too much androgen. This can lead to          serious medical problems. The standard treatment is to take pills that mimic the effects          of cortisol and aldosterone. However, treatment with pills can have long-term side          effects because of the higher doses needed, and may not work well for some people.        -  A possible new treatment for CAH is to use a pump to deliver cortisol under the skin.          Similar pumps are often used to give insulin to people with diabetes. Researchers think          that a cortisol pump might be able to help the body use the cortisol more effectively          than taking pills. They want to compare the results of a cortisol pump and standard pill          treatments for CAH.      Objectives:      - To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for     CAH.      Eligibility:      - Men and women at least 18 years of age who have CAH (see more details in Eligibility     section below).      Design:        -  This study will involve four inpatient hospital stays at the National Institutes of          Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays          will last about 5 days. The second and third stays will last about 3 days.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  At the first study visit, participants will provide regular blood and urine samples.          They will also have imaging studies. These studies will look at the bones, fat, and          muscles in the abdomen and pelvis.        -  Participants will receive a cortisol pump during the first visit. They will be shown how          to use the pump. They will also learn what to do, if they need to take extra stress          dose cortisol pills.        -  At the second and third visits, the cortisol dose given with the pump will be adjusted          as needed. Blood and urine samples will also be collected. No imaging studies are          scheduled for these visits.        -  The last study visit will have the same tests as the first visit. Participants will be          offered the chance to continue with the pump treatment for 1 more year, or go back to          their standard pill treatment.      Study type: Interventional non-randomized trial      Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone     Infusion In the Treatment of Congenital Adrenal Hyperplasia      Estimated enrollment: 8      Study Start Date: May 2013      Estimated Study Completion Date: December 2016      Sponsoring Institute: National Institute of Child Health and Human Development      <TAB>ELIGIBILITY      Inclusion criteria        1. Men and women 18 years of age or older with classic congenital adrenal hyperplasia          (21-Hydroxylase deficiency)        2. High adrenal androgens in the blood, and        3. One or more of the following conditions: obesity, fatty liver, risk for diabetes, low          bone mass, inability to tolerate cortisol pills      Exclusion criteria        1. Pregnancy        2. Breast feeding        3. Use of inhaled or oral steroids for diseases other than CAH        4. Use of estrogen-containing birth control pills        5. Use of medicines that cross-react with hydrocortisone        6. Use of stress dose steroids for illness during the last 30 days prior to joining the          study   "
108998|NCT01859299|"     Background:      - Uveitis and age-related macular degeneration (AMD) are two types of eye diseases related to     inflammation in the eyes. However, the causes of these diseases are not fully understood.     Researchers want to look at bacteria in the body that might be related to the inflammation.     They will study the natural bacteria present in the gut and intestines of people with uveitis     and AMD to learn what might trigger these diseases.      Objectives:      - To study the gut and intestinal bacteria in people with AMD and uveitis.      Eligibility:        -  Individuals at least 18 years of age who have quiet (non-inflamed) uveitis.        -  Individuals at least 18 years of age who have active (inflamed) uveitis that requires          additional treatment.        -  Individuals at least 18 years of age who have uveitis or AMD and are having immune          system therapy at the National Eye Institute.      Design:        -  Participants with quiet uveitis will have one study visit. Participants with active          uveitis will have two study visits. The second visit will be 4 to 6 months after the          first visit. Participants with uveitis or AMD who are having immune system therapy will          have two visits. The first will be before the start of the therapy, and the second visit          will be 4 to 6 months after starting the therapy.        -  About 12 hours before each study visit, participants will give themselves an enema at          home. This will clear out the lower intestine for specimen collection.        -  At each visit, participants will have a full eye examination, including vision and eye          pressure tests. They will provide blood samples for testing. They will also have an          anoscopy to collect rectal fluid and study the colon lining.        -  Treatment will not be provided as part of this study.   "
108999|NCT01859286|"     The investigators sought to determine if implementing a standardized sign out process would     reduce the amount of medical errors related to patient sign out. The standardized process     included the following interventions: implementation of a data resident to review patients     lab values, vital signs, radiologist results, and orders in real time, conducting sign out in     a standardized location and using the attending physician as an interruption manager. The     investigators defined medical errors related to sign out as any piece of information was     incorrectly reported or omitted during sign out that caused a change in treatment or     disposition discussed during sign out. The investigators hypothesis was that implementing a     standardized sign out process would lead to a decrease in the amount of sign out related     errors.   "
109000|NCT01859273|"     Despite significant advances in the care of kidney transplant recipients, long term graft     survival after renal transplantation remains suboptimal. Medication nonadherence and clinical     inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study     is to evaluate impact of a bundled wireless real time medication reminder system and blood     pressure monitoring system in combination with a cognitive behavioral adherence skills     enhancement program upon medication adherence, therapeutic drug concentration, and blood     pressure, in nonadherent kidney transplant recipients with hypertension. We propose to     recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2     for a 5-month feasibility RCT.   "
109001|NCT01859260|"     Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with chronic     kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia due to OSA     is associated with worsening kidney function. Hospitalized patients are often exposed to     multiple nephrotoxins such as antibiotics, contrast agents, and diuretics, which place them     at risk for acute worsening of kidney function. This study aims to determine whether     immediate diagnosis and treatment of OSA in CKD patients will decrease the incidence of acute     kidney injury during hospitalization. The investigators will evaluate the extent to which     this effect can be attributed to a decrease in nocturnal hypoxia and improved blood pressure     control. Secondary endpoints include hospital length of stay, and a composite outcome     comprised of hemodialysis initiation, major cardiovascular events, and mortality.   "
109002|NCT01859247|"     The overall objective of this application is to therapeutically target the dysfunctional     premotor-motor interaction in dystonia—and to provide a focused treatment of specific     anatomical networks in order to reduce side effects and to improve symptom control over     conventional therapies.   "
109003|NCT01859234|"     The purpose of this study is to see whether 89Zr-bevacizumab PET scanning is feasible in     relapsing multiple myeloma patients.   "
109004|NCT01859221|"     The purpose of this phase II study is to evaluate the outcomes of patients treated with an     investigational radiation regimen using stereotactic radiotherapy for oligometastatic     prostate cancer and to establish efficacy (producing a desired result or effect) and safety     in this setting.   "
109005|NCT01859195|"     The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal     products. The investigators will ask women to help design the best strategy for applying a     vaginal product using a specific kind of applicator. The investigators want to identify     designs that women think would be easy to prepare and insert. Women's thoughts and opinions     will help researchers develop new products called microbicides that may protect against HIV     and other sexually transmitted diseases, that are easy to use, and that will be acceptable to     women who use them. If researchers can make products that are easy to use and that women like     to use, the products will be used more often, and more infections will be prevented.      Women who enroll in the project will either participate in a focus group with approximately     3-7 other women or a one-on-one cognitive interview. All participants will complete a brief     questionnaire. Some women may enroll in both stages.      Each focus group will take approximately 1.5-2.5 hours. Group leaders will talk to women     about their experiences using vaginal products and will provide participants with study     products to look at and touch. All participants will be asked to come up with ideas of how to     make the products easy to use and acceptable to women who use them. Group leaders will     encourage discussion about the different designs. After this, group leaders will talk about a     specific type of microbicide and ask women about their opinions. In particular, researchers     and participants will talk about the language that would be best understood by women who     would use these products or be in studies to evaluate them.      Each cognitive interview will take approximately 1.5-2.5 hours. Each participant will be     asked about different product designs and application instructions, and will be asked her     thoughts, opinions, and potential concerns about each. She will also evaluate sample language     that will be used to help women understand the products and how to use them.   "
109006|NCT01859182|"     This phase II trial studies how well selumetinib and Akt inhibitor MK-2206 work in treating     patients with refractory or advanced gallbladder or bile duct cancer that cannot be removed     by surgery. Selumetinib and Akt inhibitor MK-2206 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
109007|NCT01859169|"     This research is a prospective randomized controlled trial.It aimed to determine longterm     outcomes and factors associated with increased survival after photodynamic therapy (PDT)     through T-tube compared with biliary drainage alone in patients presenting with unresectable     bile duct cancer.   "
109008|NCT01859156|"     The purpose of this study is to determine whether a relationship exists between EtCO2 and     carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner     relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.   "
109009|NCT01859143|"     This prospective annual release study is designed to evaluate the safety on new influenza     virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza     season.   "
109010|NCT01859130|"     The primary objective of this study is to obtain implant survivorship and clinical outcomes     data for commercially available Persona fixed bearing knee implants used in total knee     arthroplasty. The assessment will include implant survivorship and clinical performance     measured by pain and function, quality of life data, radiographic parameters and     survivorship.   "
109011|NCT01859117|"     This clinical study is being conducted to assess the safety and determine the maximum     tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower     leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will     look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer     healing. This study will also help to find the best dose of PDA-002 to use in future studies.   "
109012|NCT01859104|"     This current study aims to evaluate the efficacy of engagement modules in assisting patients     who are candidates for renal and liver transplantation make significant lifestyle     modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android     and iOS compatible) has been created to assist in both educating and engaging patients to     develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective,     smartphone-based platform that serves to not only efficiently educate but to also verify     competence and keep our patients engaged.   "
109015|NCT01859065|"     Kennedy et al, in a study of pediatric Emergency Department (ED) use by newborns less than 14     days of age, revealed that half of all visits in this population were non-acute problems.     Other pediatric ED utilization studies have shown similar findings in that 32% to 72% of all     visits were for non-urgent problems.      Many studies have found that primiparity and young maternal age are associated with non-acute     ED presentations. A recent factor that has been investigated is the effect of early neonatal     discharge. Some other factors are nonwhite mothers and mothers on Medicaid. Zandieh et al,     found additional predisposing determinants for non-urgent ED visits, such as single     parenthood, Hispanic ethnicity, and having perceptions that their child's overall physical     health was poor.      Paradis et al found that parents receiving a video intervention rated higher confidence with     specific infant care skills and reported feeling better prepared to care for their baby,     compared to parents receiving only handouts. However, there isn't any reported study that     evaluates the benefits of receiving both, a video intervention along with handouts.      Aim: to demonstrate whether conducting anticipatory guidance related to non-urgent problems     will reduce non-urgent ED visits, compared to care as usual (CAU) anticipatory guidance     (Sudden Infant Death Syndrome and Shaken Baby Syndrome videos; and unstructured talk about     jaundice, vaccinations, appointments, care of umbilical stump, normal urination and bowel     movement, fever).   "
109062|NCT01858454|"     The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted     laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in     myomectomy.   "
109017|NCT01859039|"     Egg allergy is common in early childhood, affecting at least one in 50 preschool children.     Influenza ('flu) vaccines contain egg protein, as the vaccine is cultured in hen's eggs.     There is robust data to support the safety of influenza vaccines (containing low or     negligible amounts of egg protein) in patients with egg allergy.      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been     approved by a number of licensing boards and is given by a spray into the nose. This new     vaccine has been available in the United States for several years and is highly effective and     against influenza infection, with an excellent safety profile in children without egg     allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO     existing data on the safety of LAIV in egg-allergic children.      The objective of this multicentre study is to assess the safety of intranasal LAIV in     egg-allergic children, in order to demonstrate that these children can safely be given the     new LAIV within a primary care health environment.   "
109018|NCT01859026|"     The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva)     given in combination are safe and have beneficial effects in patients who have NSCLC.      The U.S. Food and Drug Administration (FDA) has not approved MEK162 for use to treat NSCLC.     Erlotinib is an FDA approved drug for the treatment of Non-Small Cell Lung Cancer.   "
109019|NCT01859013|"     The prevalence of severe pediatric obesity is on the rise and youth with this condition are     at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and     type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug     Administration (FDA) for the treatment of seizures in adults and children, is associated with     weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults     have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However,     the weight loss effect of topiramate has never been evaluated among children and adolescents.     Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of     topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with     severe obesity. The primary hypothesis is that 4 weeks of meal replacement therapy followed     by 24 weeks of topiramate will have a larger average percent decline in BMI between baseline     and 28 weeks compared to meal replacement therapy followed by placebo.   "
109020|NCT01859000|"     This protocol seizes this rare scientific opportunity to test an integrative family based     model to address youths' coexisting substance abuse and trauma in the wake of Hurricane     Katrina. The study would address a number of gaps in the current evidence base related to     understanding and treating comorbid teen drug abuse and trauma that may be initiated or     exacerbated in the wake of disasters such as Hurricane Katrina. This study would compare two     promising interventions for youth with comorbid trauma and substance abuse, family-based     treatment and group Cognitive Behavioral Therapy (CBT), potentially yielding new and vital     information about effective treatment for substance abusing youth following traumatic events.   "
109021|NCT01858987|"     The optimal technique of parenchymal transection in liver surgery has remained a matter of     controversial debate among hepatobiliary surgeons. The optimal technique should enable secure     sealing of the vascular and biliary structures that results in low intraoperative blood loss     as well as low postoperative complication rates. Although numerous devices have been     introduced and are used widely, high-level evidence, randomized controlled trials, that     evaluate efficacy and safety of these devices are scarce. In the present randomized     controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure     vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a     set of general and surgical variables will be analyzed to evaluate efficacy and safety of     both methods.   "
109022|NCT01858974|"     With this study the investigators want to determine, if a fast identification of germs,     causing infections of the lower respiratory tract, is possible through the use of Multiplex     PCR technology - a method that allows on time detection of bacteria in medical specimen by     identifying DNA sequences that are known to be specific for the respective microbe. Therefore     aspiration samples from the respiratory tracts of ventilated patients, which are suspected to     develop such an infection, will be collected and analyzed by using a multiplex PCR     (polymerase chain reaction) application situated on the intensive care unit. The     investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to     conventional microbiological methods. The results of the Multiplex PCR analyses therefore     will be compared with results of conventional microbiological methods.   "
109118|NCT01857713|"     The purpose of the study is to determine the safety and effectiveness of non-invasive Reza     Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal     symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat,     throat clearing).   "
109026|NCT01858922|"     Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The     lymph system is made up of tissue throughout the body that makes and stores     infection-fighting cells. HD is one of the most treatable childhood cancers. The standard     treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation     therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured     from their cancer, some patients experience negative side effects from treatment later in     life. These kinds of side effects are often referred to as late effects. This can include     problems with growth, problems with some organ functions, and sometimes second cancers. These     types of effects can be associated with either chemotherapy or radiation therapy. The     investigators are therefore designing studies to minimize or prevent these late effects. It     is thought that if some patients can be successfully treated without radiation, those     patients might experience fewer late side effects.      Some patients, however, do not respond as well to the first stages of treatment (slow early     responders). Slow early responders are considered to be at higher risk for relapse. This     study also looks at whether these kinds of patients will benefit from additional     chemotherapy.      The purpose of this study is to look at how the immune system recovers and at how certain     T-cells in the blood behave after receiving chemotherapy with or without radiation. The     investigators also want to identify if bio-markers (special proteins in blood and in cancer)     relate to the response of HD to study treatment.   "
109063|NCT01858441|"     Prostate cancer is the 2nd leading cause of mortality in men in developed countries. For     metastatic prostate cancer patients, the 1st-line treatment relies on hormone therapy.     However, the efficacy of androgen deprivation therapy remains limited in time and most     patients eventually develop castration-resistant prostate cancer (CRPC), while remaining     androgen-dependent.      Docetaxel is currently the standard of care for metastatic CPRC. It has been shown that     testosterone levels within metastatic tumoral tissue from men receiving hormone therapy were     significantly higher than those from primitive tumors of untreated prostate cancers. Among     the mechanistic explanations for this observation, it has been shown that CYP17A1, a key     enzyme in de novo steroid synthesis localized in testis and adrenal gland, is up-regulated in     CRPC metastases. The existence of de novo CYP17A1-dependent androgen biosynthesis at the     tumor level has supported the development of novel antiandrogens, including abiraterone     acetate (AA), an irreversible CYP17A1 inhibitor. Based on a placebo-controlled phase III     trial, demonstrating that abiraterone prolonged overall survival (14.8 vs 10.9 months) and     increased PSA response rate (29% vs 6%) in patients with metastatic CRPC who previously     received docetaxel, AA was recently approved by the FDA and French Health Authorities. AA is     well-tolerated and main toxicities are urinary tract infections (2%) and a syndrome of     secondary mineralocorticoid excess characterized by fluid overload, hypertension and     hypokaliema (1% to 4% of grade 3-4).      Almost concomitantly, a novel taxane-class cytotoxic agent, cabazitaxel, has proven efficacy     in CRPC treatment after failure to docetaxel, and has recently been approved by the FDA and     French Health Authority. Although cabazitaxel exhibits a less favorable toxicity profile,     this precise context creates a need to dispose of objective individual criteria so as to     orientate patients to treatment towards AA or towards cabazitaxel. To this purpose, several     approaches are of potential interest for identifying good candidates for a treatment by AA:     tumor-specific TMPRSS2-ERG gene fusion measurement, circulating tumor cell analysis, tumoral     CYP17A1 expression, analysis of splicing forms of the androgen receptor. However, the     clinical relevance of these potential predictive factors remains to be established in this     setting.      Pharmacogenetics examines germinal gene polymorphisms likely to influence the     pharmacodynamics of anticancer agents. Encouraging results have recently been reported by our     group for irinotecan pharmacogenetics with concrete possibilities of individual dose     adaptations, and very recently by other investigators for sunitinib pharmacogenetics.     Concerning AA, one can hypothesize that tumors with elevated CYP17A1 expression will be more     likely to respond better to AA. This hypothesis is indirectly supported by the observation     that in CPRC patients receiving AA, PSA-based response is higher in patients with elevated     pre-treatment blood concentration of DHEA and androstenedione.      The CYP17A1 gene presents numerous single nucleotide polymorphisms (SNPs), whose frequencies     of rare alleles are at least 12%. Their functional impact has been suggested for nine of     them, which were linked either to the risk of developing prostate cancer or to survival of     prostate cancer patients. So far, no study has examined the links between these polymorphisms     and the efficacy of a CYP17A1 inhibitor. Also, relationships with the efficacy of androgen     deprivation therapy have recently been reported for SNPs of genes involved in the     membrane-transport testosterone and dehydroepiandrosterone, namely SLCO2B1 and SLCO1B3. One     can make the hypothesis that gene polymorphisms of these transporters may play a role for the     intratumoral concentration of testosterone locally-produced through the mediation of CYP17A1     activity.      To resume, two second-line treatments of metastatic CRPC cancers are currently available,     thus is raising the question in practice of which treatment is more appropriate for a given     patient. Herein, the present study proposes an original pharmacogenetic approach in order to     highlight a relationship between AA activity and patient's genetic profile. Ultimately, this     could reveal evidences of genetic predispositions for potentially good responders to AA     treatment.   "
109064|NCT01858428|"     This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated     percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with     peripheral arterial disease.   "
109027|NCT01858909|"     OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with     severe sepsis and septic shock.      Specifically:        1. To evaluate the survival to 28 days of mechanical assisted ventilation, days with          vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution          towards the failure of other organs.        2. To evaluate, waiting for reduction under the influence of the treatment with melatonin,          :             1. clinical - analytical parameters of sepsis;             2. levels of cytokines;             3. oxidative and nitrosative stress;             4. acute-phase proteins (APP), specially of the ITIH4;             5. immune response;             6. endocrine response.      METHODOLOGY. Patients will be randomized in two groups, n = 55 in each group: 1) treatment     with melatonin 30mg/12 hours 28 days; 2) placebo.      Determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin     plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein     carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase,     catalase, glutathione reductase and glutathione peroxidase activity; d) Interleukins-1,2,4,5,     6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF; e) acute-phase proteins: PCR, haptoglobin, Apo A-I,     α1-GPA and ITIH4; f) lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins; g)     cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3. Data will be     analyzed following a prospectively define plan and by intention-to-treat (ITT) analysis.   "
109028|NCT01858896|"     Low blood sugar can negatively affect how blood vessels function, and this can lead to an     increase in the risk for heart attacks, strokes and other problems related to the stiffening     and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like     peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low     blood sugar levels have on blood vessels.   "
109029|NCT01858883|"     Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination     with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.   "
109030|NCT01858870|"     Lacosamide is an antiepileptic drug approved for using like adjuvant treatment in adults     epileptic crisis.      Previous studies has granted to the adjuvant therapy a significant efficacy. This is an     observational study, multicenter and retrospective, in patients with epilepsy. The aim of     study is the evaluation of the adjuvant treatment with Lacosamide administered over 12     months.      The investigators will collect information from 860 patients in 13 spanish centers.      The secondary aim is assess the tolerability of treatment during 3,6 and 12 month.   "
109031|NCT01858857|"     The purpose of this observational multicenter-study is to investigate safety of     psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric     inpatients. Elderly people are at higher risk for developing side effects under     pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and     often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their     symptoms clearly, for example due to pronounced cognitive impairment.      The aim of the study is to gain valid data of possible adverse drug reaction rates, their     potential risk factors and outcome, as well as medical prescription practises.      To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the     five participating study sites.      At Baseline demographic data, previous and present disorders, use of drugs, previous and     present medication, quality of life, cognitive function, physical examination results,     laboratory results and ECG will be assessed.      Afterwards patients are visited weekly and screened for possible adverse drug reactions. All     adverse drug reactions will be coded in the MedDRA-system.      In case of a possible serious adverse drug reaction serum levels of all psychotropic     substances applicated will be assessed. Drug combinations will be analysed using an     established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible     adverse drug reactions are documented continually.      2 weeks after discharge from the ward, patients will be contacted by phone to assess     catamnestic data.   "
109032|NCT01858844|"     Evaluate the effect of chest manual compression technique (CCT) in the variables of     oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are     associated with atelectasis.   "
109033|NCT01858831|"     This study will be a single-center, phase I, randomized, open, in fed condition, parallel,     single dose study to evaluate the pharmacokinetics and the safety, tolerability of     Atovaquone/proguanil combination tablets and atovaquone suspension in Japanese healthy male     subjects.      Serial blood samples will be collected for the determination of the plasma concentration of     atovaquone, proguanil and cycloguanil after dosing of atovaquone 1000mg/proguanil 400 mg and     the plasma atovaquone concentration of atovaquone 750 and 1500 mg. Safety assessments will be     performed for each treatment group.      CYP2C19 contribute to proguanil metabolism. CYP2C19 genotype will be determined in     atovaquone/proguanil dosing group.   "
111002|NCT01833039|"     The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell     Lymphoma (MCL) with early access to an investigational medication called ibrutinib     (PCI-32765) and to collect safety information about the drug.   "
109034|NCT01858818|"     This project aims to investigate how dysfunctional learning and habitization are affected by     acute alcohol exposure, and whether individual differences in such alcohol effects can     predict later development of Alcohol Use Disorders (AUDs). Eighty 18-year-old healthy male     subjects are tested on two days in a within-subjects design with blinded administration of     alcohol vs. placebo and different behavioral and learning tasks. The investigators     investigate how alcohol influences the performance during these tasks, whether alcohol     effects differ between high- and low-risk subjects, and whether task performance under     alcohol predicts future AUDs.   "
109035|NCT01858805|"     Despite the availability of several preoperative diagnostic techniques, accurate pretreatment     staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated     the prognostic significance of circulating tumor cells (CTCs) in patients with EC.   "
109036|NCT01858792|"     Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients     with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of     the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies   "
109065|NCT01858415|"     The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This     study was designed in order to evaluate the safety and efficacy of the TriPollar.   "
109037|NCT01858779|"     Atrial fibrillation (AF) is the most common cause of cardioembolism and a leading cause of     ischemic stroke. The diagnosis of AF after cerebral ischemia is difficult to establish even     during the treatment at specialised stroke units, as paroxysmal episodes may terminate     spontaneously before arrival at the hospital and do not always show early recurrence.     However, the diagnosis of AF is of particular clinical relevance since adaequate     anticoagulation is one of the most effective secondary preventive treatments in stroke. The     detection rate of AF after stroke increases progressively by extending the duration and     intensity of cardiac monitoring. For this purpose innovative medical devices and implantable     event recorders have been suggested. However, high socioeconomic expenses, malcompliance and     the invasiveness of some of these approaches currently limit their use to a minority of     affected patients, while the growing number of stroke survivors is lacking access to free and     simple screening tools.      For primary prevention, the measurement of the peripheral pulse (MPP) is currently the only     guideline-recommended screening method among individuals aged 65 years or older. In contrast,     MPP has never been applied in the setting of secondary stroke prevention, probably because     several factors were expected to interfere with this simple technique, including sensomotor     and neuropsychiologic handicaps of stroke patients 18. This study investigates feasibility     and validity of MPP in this cohort (pilot phase) and compares daily MPP for 6 months with     repeated holter-ECG in patients after ischemic stroke.   "
109038|NCT01858766|"     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and     tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)     in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus     (HCV) infection.   "
109039|NCT01858753|"     This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to     determine whether injection of autologous fibroblasts can increase the mobility (decrease the     restriction) of burn scars. The study will assess the effects of azficel-T (autologous     fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia     (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute     to the restriction) and that is either:        1. An axillary scar causing 20-60% restriction of shoulder adduction        2. An anterior elbow scar causing 20-60% restriction of elbow extension        3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or          extension      Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7     days) apart (depending on cell availability) and will be followed for efficacy (including     range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for     safety to Visit 9 at 1 year.   "
109040|NCT01858740|"     This phase II trial studies how well T cell depleted donor peripheral blood stem cell     transplant works in preventing graft-versus-host disease in younger patients with high risk     hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop     the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted     cells from a donor can make an immune response against the body's normal cells. Removing a     subset of the T cells from the donor cells before transplant may stop this from happening.   "
109041|NCT01858727|"     30 patients American society of anesthesiology (ASA) physical status I,II and III undergoing     general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will     be included in the study. Patients will be randomized into two groups; first group(control     group) and second group (forced-air warming). Resistive heating will start when patients are     transferred to the operating room table; forced-air warming will start before preoperative 30     minute.   "
109042|NCT01858714|"     The major goal of this project is to evaluate an innovative approach to obesity involving     modification of the home environment. The project also will evaluate if home environment     modification is more effective when supplemented with distress tolerance and related skills     training.   "
109043|NCT01858701|"     The purpose of this study is to compare the amount of coma as measured by aberrometry induced     by two silicone hydrogel toric lenses in astigmatic participants.   "
109058|NCT01858506|"     Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and     education among Arab people with diabetes who have varying literacy skills using an     interactive computerized tool and graphically-enhanced patient logs for dietary and physical     activity.      The investigators hypothesize that this tool will: a) increase patients' knowledge and     understanding of the role of lifestyle (diet and physical activity) in diabetes management;     b) improve patients' engagement in monitoring dietary intake and physical activity; c)     improve dietary and physical activity behaviors and self-blood glucose monitoring (SBGM)     practices; d) improve glycemic control; and, e) improve the efficiency of lifestyle     assessment, education and counseling while increasing patients' engagement in the process.   "
109059|NCT01858493|"     To determine whether women exposed to the continence promotion intervention will report     improved urinary symptoms and quality of life, and lower incontinence-related stigma and     falls than women who receive a control intervention at one-year post-intervention.   "
109066|NCT01858402|"     We conducted a prospective, randomized double-blind study to compare the effectiveness of     intravenous paracetamol and dipyrone for preventing pain during early postoperative period in     school-age children undergoing lower abdominal surgery with spinal anesthesia.   "
109067|NCT01858389|"     This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each     two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of     patients, those whose tumor has a documented T790M mutation, and those without this mutation.     All patients will receive repeated cycles of dacomitinib until disease progression,     occurrence of unacceptable toxicity, or other withdrawal criteria are met.   "
109068|NCT01858376|"     The hypothesis of this study is that the natural supplement Capros will decrease LDL levels,     platelet aggregation, and serum concentrations of high sensitivity C-reactive protein in     humans at risk for cardiovascular disease.   "
109140|NCT01857427|"     The primary objective of this study is to build a well characterized cohort of patients that     will be used to determine the genetic variants associated with obstructive sleep apnea     (OSA)and its co-morbidities.   "
109044|NCT01858688|"     Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather,     they can be followed closely with regular physical exams, blood work and repeated biopsies of     the prostate. If the prostate cancer is becoming more aggressive, curative treatment can be     offered at that time. This strategy of delaying treatment until necessary is called active     surveillance in prostate cancer.      Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay     unnecessary treatment in men with less aggressive cancer.      Prostate cancer can be slow growing and, for many men, the disease may never progress or     cause any symptoms. In other words, many men with prostate cancer will never need any     treatment. Treatments for prostate cancer may cause side effects which can affect your     quality of life. By monitoring the cancer with regular tests, you can avoid or delay these     side effects.      Active surveillance is generally suitable for men with low risk early stage prostate cancer     that is contained within the prostate gland (localized prostate cancer).      If doctors had a better way of identifying who might be best suited for this approach, it     would likely become more appealing for more men. In this study, the investigators are looking     at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk prostate     cancer, which might make a man a poor candidate for active surveillance.      To do this, the investigators are collecting data from the MRI scan of men and comparing it     to a trans-rectal biopsy performed following the scan. The results of this study will help     inform doctors how accurate the MRI is in identifying men who should not be on active     surveillance.   "
109045|NCT01858675|"     The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR     proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro     Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with     Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on     albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such     as erythropoietin and catecholamines. 80 ICU patients are included.   "
109046|NCT01858662|"     To analyze the pathological tumor response on resected colorectal cancer metastases after     preoperative treatment with cetuximab combined with FOLFOX or FOLFIRI regimen in a     prospective cohort (RAS and B-RAF WT tumors) and to correlate this response with patient's     outcome.   "
109047|NCT01858649|"     The study is designed to analyze the pathological tumor response on resected colorectal     cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or     FOLFIRI regimen in a prospective cohort and to correlate this response with patient's     outcome.   "
109048|NCT01858636|"     To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen     through the collection of device/procedure-related major vascular complications and time to     hemostasis.   "
109049|NCT01858623|"     This study was conducted to investigate any potential reaction between losartan and     hydrochlorothiazide.   "
109050|NCT01858610|"     This study was conducted to investigate any potential reaction between irbesartan and     hydrochlorothiazide.   "
109051|NCT01858597|"     Gestational diabetes mellitus (GDM) is the most common complication in pregnancy. Both mother     and offspring have a significantly increased future risk for metabolic and cardiovascular     disease as a consequence of GDM. Pathological insulin resistance and the pancreatic β-cell     dysfunction may contribute to the development and adverse outcomes of GDM.      Recently, fibroblast growth factor 19 (FGF19) and FGF21 have emerged as key endocrine     regulators of glucose, lipid and energy metabolism. Both factors activate FGFRs in the     context of co-receptor βKlotho(KLB) expression. After that, both proteins alter ERK     phosphorylation and stimulate glucose uptake. Furthermore, these two factors ameliorate     insulin resistance through various ways including up-regulating insulin mRNA, IRS-1, GLUT-1     expressions, down-regulating GH-IGF-1 levels in different tissues and blood circulation and     also improving dyslipidemia.      Our previous studies showed that several factors which involved in insulin resistance and     FGF19/FGF21 signaling pathway had differential expression in placenta from GDM and normal     glucose tolerance pregnancy. Those led us to hypothesize that FGF19/FGF21 signaling pathway     could play an important role in the pathogenesis and development of insulin resistance state     in GDM.      In the present study, we will further investigate whether maternal and neonatal FGF19/FGF21     signaling pathway are altered and associated with insulin resistance, glucose intolerance,     dyslipidemia and adverse pregnancy outcomes. Thus we will evaluate the regulating action of     FGF19/FGF21 on gestational insulin resistance.      The aim of this study is to elucidate the role of FGF19/FGF21 in insulin resistance and     metabolic disorder in GDM.   "
109052|NCT01858584|"     The results on the efficacy of the formulations based on alginic acid are controversial.     Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by     evaluation with pH-impedance analysis. This study concludes that the use of alginic acid     reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a     lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and     proton pump inhibitor (PPI).   "
109053|NCT01858571|"     Many of the pediatric malignancies are not curable on progression on front line or 2nd line     chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases     the QOL. The usual therapy offered to such patients is best supportive care.      Metronomic chemotherapy can induce tumor stabilization or tumor responses in patients with     cancer that are refractory or have relapsed after conventional chemotherapy. Whether     metronomic therapy is better than best supportive care is not known. In order to do so, a     study is required which may compare metronomic therapy with a placebo therapy on PFS and QOL     in relapsed refractory cases of pediatric solid tumors who have failed at least two lines of     chemotherapy.      HYPOTHESIS      The investigators hypothesize that metronomic chemotherapy in progressive pediatric     malignancy will improve PFS and QOL. If validated, then this form for therapy will be an     option for both the patients and the clinicians, who are left with just an option of best     supportive care in such situations of progressive pediatric cancers despite multiple lines of     chemotherapy.   "
109054|NCT01858558|"     This research is being done to find out if altering the immune system by giving Prevnar     vaccine, Tadalafil, and activated marrow infiltrating lymphocytes (MILs) can improve outcomes     for multiple myeloma patients who receive a standard autologous stem cell transplant.   "
142765|NCT01415791|"     The purpose of this study is to investigate the presence or absence of oral mucosal     absorption of ICI176,334-1   "
109070|NCT01858350|"     The investigators conducted a prospective open unblinded clinical four-arm evaluation of     Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who     were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation.     Children were assigned to active music therapy, passive music therapy, distraction therapy,     and no intervention; measures included doses and numbers of sedation medications, time of     sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines,     before and immediately after the intervention was completed. The Time Frame for the outcome     measures are at the start of the intervention and immediately following the procedure     (generally about 150 minutes). No further follow up was conducted.   "
109071|NCT01858337|"     -  Rationale: Despite the health benefits, children's consumption of vegetables is below          the recommendations. Most human food preferences are learned through mere exposure,          imitation, and conditioning principles. During the last years, it has become clear that          the development of food preferences starts very early in life. Furthermore, preferences          that are learned early in life, are relatively stable and may track into adulthood.          However, it is unclear how vegetable preferences develop from infancy until young          childhood. In order to influence vegetable consumption, it is essential to study the          opportunities to develop a preference for vegetable products early in childhood.        -  Objective: The aim of this study is to investigate the effect of repeated exposure to          vegetables compared to repeated exposure to fruit during weaning on short and long term          vegetable and fruit intake. Furthermore, the stability of the learned fruit or vegetable          preferences and the later food preferences are measured (i.e. vegetable, fruits,          sweets).        -  Study design:      In this longitudinal study we will measure the development of preferences for a particular     vegetable or fruit type within 4 to 6 months old subjects, during a 19 day exposure period to     fruit or vegetables (of which 9 days exposure to the target fruit or vegetable) and 6 months     after this exposure period. In addition, we compare the food preferences (fruit, vegetable,     sweet foods in general), after 6 months, between infants who were weaned with a variety of     fruits and infants who were weaned with a variety of vegetables.   "
109072|NCT01858324|"     Hypertensive disorders of pregnancy happen in 5% of pregnancies. Being aware of symptoms and     complications may help women to present early and preserve their own and their baby's health.      The proposed research aims to evaluate the impact of educational tools in pregnant women from     an ambulatory population. These tools include a detailed pamphlet (including a graphic-based     summary), a magnet summarizing symptoms and appropriate action, and a video. Level of     knowledge will be evaluated after one month with a validated questionnaire. We will also     evaluate if getting more information about preeclampsia increases patient anxiety as well as     satisfaction about the tools.   "
109073|NCT01858311|"     A natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol     lowering properties, both of which may benefit stroke survivors. This study is being     conducted to determine the blood thinning and cholesterol lowering properties of TCT in     stroke or TIA (transient ischemic attack, which is also referred to as a mini-stroke)     survivors that are receiving the standard treatment for prevention of recurrent stroke.      Study Hypothesis: Oral TCT decreases the incidence of aspirin and clopidogrel nonresponders,     increases the extent of inhibition of platelet aggregation, and decreases LDL without     significant side effects in stroke patients.   "
109074|NCT01858298|"     The purpose of this study is to compare the effectiveness of the conservative (pulpectomy)     versus non-conservative treatment (tooth extraction) of primary molars affected with severe     dental caries associated to oral health-related quality of life, anthropometric and clinical     outcomes.   "
111417|NCT01827579|"     The purpose of this study is to evaluate whether the administration of allodepleted donor T     cells to patients with haematological malignancies after stem cell transplant can improve the     recovery of the patients immune system.   "
109076|NCT01858272|"     The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an     intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary     endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for     the intra-ulcer injection of H5.020CMV.PDGF-b.   "
109077|NCT01858259|"     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of     the skin and all internal organs. Interstitial lung disease is a frequent morbidity and     mortality-driving manifestation in systemic sclerosis.      This observational trial (OT) is part of the collaborative project DeSScipher, one out of     five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational     try is to identify:        -  The state of clinical practice in Europe for prevention and treatment of interstitial          lung disease and its impact on lung function and disease progression        -  The potential predictors and confounders for response to therapy   "
109078|NCT01858246|"     The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to     randomize patients to receive either the Bonebridge or a conventional bone conducting hearing     device. The investigators will then compare the surgical and audiological outcomes of the two     groups.   "
109079|NCT01858233|"     The IBEP study is a randomized control trial of a healthy lifestyle intervention program for     women with gestational diabetes. The primary aim of the study is to evaluate whether women     with gestational diabetes enrolled in an intensive behavioral educational program (IBEP)     demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose     tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who     undergo routine gestational diabetes education and counseling.   "
109080|NCT01858220|"     Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of     mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness     (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become     a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized     to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac     disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and     usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim     of the study is to determine the correlation between gasytoparesis symptoms to duration of     capsule retention in the stomach   "
109081|NCT01858207|"     Abstract of Research Proposal Radiofrequency ablation (RFA) has been proved to be a curative     treatment with minimal invasiveness and high efficacy for small hepatocellular carcinoma     (HCC) that is generally defined as maximal diameter no larger than 3cm. RFA can achieve a     rate of complete necrosis as 80-100% in small HCC. However, the rate will drop to 71% in HCC     of 3.1-5cm and 25% for HCC larger than 5cm。This is due to the relative hypervascularity for     the bigger tumor and it will induce heat sink that leading to less effect of ablation.     Therefore, transcatheter chemoembolization (TACE) before RFA may reduce the vascularity and     enhance the effect of subsequent RFA. Moreover, pre-RF TACE will reduce the tumor size and     the subsequent RFA will be more effective than RFA alone. In retrospective studies, Kitamoto     M et al showed that tumor necrosis diameter was larger in TACE and RFA combination therapies     compared to RFA mono-therapy; Yamakado K et al showed that TACE and RFA combination therapies     in HCC (maximal diameter up to 12 cm) achieved 100% complete necrosis, 0% local recurrence     rate and 93% of 2-year survival rate. Nevertheless, only one randomized trial in intermediate     size HCC (3-5cm in diameter) showed that TACE and RFA combination therapies achieved a     significant higher rate of complete necrosis, technique success, fewer treatment sessions to     achieve complete necrosis and lower local recurrence but non-significant difference in 3-year     survival rate. Therefore, based on the limited studies, combine TACE and RFA may achieve     better effects than RFA mono-therapy in HCC larger than 3cm. However, repeat TACE may induce     some complications such as HBV reactivation, hepatitis or even liver decompensation.     Moreover, novel RFA using simultaneous multiple RFA probes with switching RF controller may     achieve a better effects and shorter ablation time than sequential RFA with single electrode.     Thus, is it still necessary using TACE and RFA combination therapies for HCC >3cm when     application of novel switching RF controller? The aim of the current study is to conduct a     RCT comparing combine TACE and RFA compared to RFA mono-therapy by using simultaneous     multiple electrodes and switching RF controller in uni-lobar HCC of 3.1-7cm. The rate of     complete necrosis, technique success, sessions to achieve CN, local tumor progression,     survival rate and major complications will be analyzed. Investigators cannot expect which one     is better, safer before the achievement of the study.   "
109082|NCT01858194|"     Despite significant advances in the management of ventricular arrhythmias through the use of     ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain.     The optimal method for the prevention of recurrent VT following catheter ablation remains     unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated     ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the     renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has     been shown to reduce the recurrence of VT in a case report of 2 patients suffering from     electrical storm, to date no large prospective randomized study has evaluated the impact of     RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with     ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the     safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with     ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT     ablation.   "
109083|NCT01858181|"     Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting     the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an     increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity     (ADCC) effector function.      A previous phase I/II study of intravenously (IV) administered ocaratuzumab in     refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and     well-tolerated at doses up to 375mg/ m2 weekly for four weeks.      In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients     with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses,     80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety,     tolerability, pharmacokinetic, and pharmacodynamic analyses.   "
109084|NCT01858168|"     This research study is a Two arm Phase I clinical trial, which tests the safety of an     investigational drug or combination of drugs and also tries to define the appropriate dose of     the combination of investigational drugs to use for further studies. Investigational means     that the combination of drugs is being studied. It also means that the FDA has not yet     approved the combination of drugs for your type of cancer.      Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase     (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and     enable them to continue dividing. Olaparib has been used in research studies with other     cancers. Information from those other research studies suggests that this drug may help to     treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for     any use outside of research studies.      Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor,     glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is     not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for     relapsed disease.      Irinotecan is approved by the FDA for the treatment of gastrointestinal cancers. It has been     studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA     for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.      Laboratory studies suggest that the combination of olaparib and temozolomide and irinotecan     may help kill Ewing sarcoma cells.      In this research study, the investigators are looking for the highest dose of the combination     of olaparib and irinotecan and/or temozolomide that can be given safely. The investigators     will also begin to collect information about the effects of the combination on Ewing sarcoma.   "
109086|NCT01858142|"     Children are distressed at anesthesia induction and this distress can result in maladaptive     recovery outcomes. Having parents be present at anesthesia induction (PPIA) has been     suggested as a potential intervention to decrease children's distress, and this intervention     is widely favored by parents. However, to date, PPIA has not been found to be effective in     reducing children's anxiety. The lack of efficacy may be attributable to the fact that     parents have generally not been prepared for PPIA. The one study that prepared parents (as     part of a larger preoperative preparation program) found that PPIA with preparation was     superior to PPIA as previously studied (without preparation). Unfortunately, this program is     resource intensive and therefore is not clinically feasible. This study will compare PPIA     with a clinically feasible preparation program to PPIA with standard care (minimal     preparation). Should our intervention show evidence of efficacy, the investigators will have     designed a program that is easily translatable to everyday clinical practice. This will, in     turn, reduce children's anxiety, improve postoperative outcomes and increase parental     satisfaction.   "
109087|NCT01858129|"     Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late     preterm and term babies caused by lung edema resulting from delayed absorption of fetal     alveolar lung fluid.      The investigators hypothesize that ENAC expression will be up-regulated as a result of     administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung     fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled     corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates     presenting with TTN.   "
109088|NCT01858116|"     The study will evaluate [68Ga]ABY-025 for PET imaging of HER2 expression in subjects with     HER2-positive or HER2-negative breast cancer.   "
109089|NCT01858103|"     The Expanded Access Program (EAP) is an open-label, multicenter program to:        1. Provide patients who have been diagnosed with Mucopolysaccharidosis IVA (MPS IVA) access          to BMN 110 until commercial product is available        2. Collect additional information on the safety and tolerability of BMN 110 administration          in patients with MPS IVA      Patients enrolled in the EAP will receive 2.0 mg/kg intravenous infusions of BMN 110 every     week during the program.   "
109194|NCT01856725|"     The purpose of this study is to compare the efficacy of cardiac resynchronization therapy     (CRT) device programming with hemodynamic measurements to device programming without     hemodynamic measurements.   "
109093|NCT01858051|"     In the United States, ~1 million elective hip or knee replacement surgeries are performed     annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents     ~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint     replacement surgery. Although SSIs only account for 20% of all HAIs, they are a major risk     factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also been identified as     an independent risk factor for infections of implanted hardware.      In general, the majority of PJIs become apparent within 3 months of hardware implantation,     but deep infections may not be evident for up to one year after surgery. Hardware infections     result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy.     PJIs are associated with an average increase in hospital LOS by 14 days, additional     expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate     compared to uninfected lower extremity joint replacements.      Recent work from our group suggests that vitamin D insufficiency may be a risk factor for     perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in     elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in     the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. To     date, perioperative vitamin D optimization strategies have not been reported. Therefore, our     goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and     on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in     patients scheduled for elective hip or knee joint replacement surgery.   "
109094|NCT01858038|"     This project aims to understand the molecular biology underlying the improvement of surgical     scars treated by ablative fractional photothermolysis (FP). Previous human studies at MGH     have shown that FP significantly improves the appearance and functionality of surgical and     burn scars. At the Wellman Center, we have conducted a randomized, controlled study on linear     surgical scars demonstrating the efficacy of FP to decrease the volume of hypertrophic scars,     and to improve the appearance and texture of scars. However, the underlying mechanism of this     therapeutic effect is unknown. It is clear that FP induces wound healing and remodeling of     the normal skin surrounding microthermal zones (MTZs). Furthermore, other researchers have     employed animal models using transgenic zebrafish and the mouse eye, and found that laser     treatments induce changes in gene expression in specific cells. We propose to determine     whether the effect of FP on scar improvement occurs via changes in patterns of local gene     expression within the skin, specifically dermal fibroblasts. By characterizing these changes,     we may be able to identify molecular mechanisms that both explain and contribute to the     beneficial effects of FP in the surgical and traumatic scar. The molecular insights into the     therapeutic effects of fractional laser photothermolysis may provide a basis for future     therapeutic strategies to improve scar remodeling.   "
109104|NCT01857908|"     Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate     treatment, particularly at the time of progression. Biomarkers may also help identify     pathways to resistance of abiraterone acetate treatment. The most practical way of     approaching this question is to explore surrogate biomarkers of prostate cancer including     quantification of pharmacodynamic endocrine biomarkers.   "
111441|NCT01827254|"     Retrospective and prospective study in mRCC patients treated with sutent in first line and     rechallenged by Sutent in 3rd and 4th line.   "
109095|NCT01858025|"     This research study is a Pilot Study. Pilot studies are conducted to see if it is practical     to do this type of research ona larger scale in the future. The pilot part of the study is to     assess the possibility of using pencil beam proton radiation to treat your type of cancer.     Proton radiation is used for many other types of malignancies, but its use for the treatment     of anal cancer has been limited. The treatment is still being studied as research doctors are     trying to find out more about its use in the treatment of anal cancer. Proton beam radiation     therapy is an FDA approved radiation delivery system.      You are being asked to participate in this study because you have cancer in the anal canal.     Conventional radiation therapy with photons in combination with 5-FU and mitomycin-C is used     as standard treatment for many patients with anal cancer.      In this research study we are looking at another type of radiation called proton radiation,     which is known to spare surrounding tissue and organs from radiation. Proton radiation     delivers radiation to the area requiring radiation but delivers no dose beyond the region     requiring treatment. There are several techniques that can be used to deliver proton     radiation therapy. One of the newer techniques, called pencil beam scanning, allows for more     accurate delivery of radiation to your tumor and further reduces the amount of normal tissue     exposed to radiation. Most proton patients are treated with a number of beams that study     doctors conform to the shape of your tumor. Pencil beam scanning delivers radiation with a     single, narrow proton beam that is swept over the area of your tumor. This may reduce side     effects that patients would normally experience with conventional radiation therapy or other     means of delivering proton radiation therapy, and also minimizes treatment time.      In this research study, we are evaluating the effectiveness of using pencil beam proton     radiation delivered to reduce side effects associated with radiation treatment.   "
109096|NCT01858012|"     The study hypothesis is that the means by which HCV induces glucose intolerance is through     impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with     insulin resistance and that HCV eradication improves these abnormalities. It is also     hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with     Latinos with or without HCV infection.   "
109097|NCT01857999|"     The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting     enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients     has been demonstrated to be beneficial. However, the dual inhibition has not been studied     during heart failure decompensation or even when low cardiac output is present.      The objective of this study was to assess the effects of add-on therapy with angiotensin     receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in     heart failure patients with low cardiac output during hospitalization for decompensation.      This was a randomized, double-blind, placebo-controlled clinical trial.   "
109098|NCT01857986|"     This trial is designed to assess the effectiveness of the AnapnoGaurd 100 system relative to     standard of care (SOC) Control, in the course of mechanical ventilation and intubation. The     main effectiveness aspect of this trial is the AnapnoGaurd 100's ability to reduce leaks     between the endotracheal tube and the trachea walls as a result of the cuff pressure     management. Since the primary outcome can't be measured by any method other than the     investigational device, the study groups will be treated as follows:        -  The Treatment group in this study will be treated with the fully functional AnapnoGaurd          100 device (per its intended use),        -  The Control group will be treated with the AnapnoGuard device, where the cuff control          will be disabled (off) and the cuff management will be done according to SOC.      Effectiveness will be measured by the duration and level of carbon dioxide (CO2) leakage     around the endotracheal tube (ETT) cuff, from the lungs to the subglottic space and safety     will be measured by adverse events (AEs).   "
119239|NCT01725165|"     The goal of this clinical research study is to learn if surgery or radiation after     chemotherapy can help to control NSCLC. The safety of this treatment will also be studied.   "
109100|NCT01857960|"     Acne is a chronic inflammatory disease that affects almost 100% of the teenagers worldwide.     The peak incidence is between 12 and 18 years old, although it can be present in adults.     There are many different beliefs about what can cause or exacerbate acne, and also about     treatment.      In Mexico, 26.4% of the population is between 15 and 29 years old, which represents that more     than 25% of the population is at risk for presenting acne. In our country, the different     beliefs about the causes and treatment of acne among general adolescent population have not     been explored. The objective of the present study is to determine the possible causes for     which young Mexicans do not go to the dermatologist to receive treatment for acne. Our main     hypothesis is that the lack of knowledge of the disease is responsible for this behavior.   "
109101|NCT01857947|"     The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition     to clinical evaluation is effective to predict outcome of acute exacerbations of COPD     patients visiting the emergency room(ER).   "
109102|NCT01857934|"     Neuroblastoma is the most common extracranial solid tumor in childhood, with nearly 50% of     patients presenting with widespread metastatic disease. The current treatment for this group     of high-risk patients includes intensive multi-agent chemotherapy (induction) followed by     myeloablative therapy with stem-cell rescue (consolidation) and then treatment of minimal     residual disease (MRD) with isotretinoin. Recently a new standard of care was established by     enhancing the treatment of MRD with the addition of a monoclonal antibody (ch14.18) which     targets a tumor-associated antigen, the disialoganglioside GD2, which is uniformly expressed     by neuroblasts. Despite improvement in 2-year event-free survival (EFS) of 20%, more than     one-third of children with high-risk neuroblastoma (HR defined in) still cannot be cured by     this approach. Therefore, novel therapeutic approaches are needed for this subset of     patients. This study will be a pilot Phase II study of a unique anti-disialoganglioside     (anti-GD2) monoclonal antibody (mAb) called hu14.18K322A, given with induction chemotherapy.      PRIMARY OBJECTIVE:        -  To study the efficacy [response: complete remission + partial remission (CR+PR)] to two          initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4          doses/course followed by GM-CSF) in previously untreated children with high-risk          neuroblastoma.        -  To estimate the event-free survival of patients with newly diagnosed high-risk          neuroblastoma treated with the addition of hu14.18K322A to treatment.      SECONDARY OBJECTIVES:        -  To study the feasibility of delivering hu14.18K322A to 6 cycles induction chemotherapy          and describe the antitumor activity (CR+PR) of this 6 course induction therapy.        -  To estimate local control and pattern of failure associated with focal intensity          modulated or proton beam radiation therapy dose delivery in high-risk abdominal          neuroblastoma.        -  To describe the tolerability of four doses of hu14.18K322A with allogeneic natural          killer (NK) cells from an acceptable parent, in the immediate post-transplant period          [day +2 - +5 after peripheral blood stem cell (PBSC) infusion] in consenting          participants.        -  To describe the tolerability of hu14.18K322A with interleukin-2 and GM-CSF as treatment          for minimal residual disease (MRD).   "
109103|NCT01857921|"     Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory properties.     In addition, previous reports showed that trimetazidine was effective in reducing     intracoronary platelet aggregation and preventing platelet thrombogenesis. Therefore, for the     evaluation of these combination effects of statin and trimetazidine on patients with aspirin     monotherapy who had previously received CABG and were free of the major adverse cardiac     events such as death, MI, TLR, or TVR for 12 months, the investigators hypothesize that     atorvastatin 40mg/day would be more effective in the prevention of the further late adverse     cardiac and cerebrovascular events than other statin. To test this hypothesis, the     investigators will perform a multi-center, randomized, prospective trial aimed at     demonstrating the superiority of combination of high dose atorvastatin therapy and     trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG     surgery in real world practice.   "
109105|NCT01857895|"     This is an open-label study to investigate the feasibility of administering exenatide by     continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e.     Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours     followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B     approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum     of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.   "
109106|NCT01857882|"     The purpose of this study is to determine the effectiveness of a pre-consultation decision     support workshop for breast reconstruction after breast cancer, in facilitating the     decision-making process, compared to routine pre-surgical education.   "
109107|NCT01857869|"     This study is designed to evaluate safety, reactogenicity, immunogenicity, and efficacy of     GSK Biological's malaria candidate vaccine 257049 administered as standard doses at 0 and 1     months and 1/5th standard dose at 7 months (delayed fractional dose group) and 257049     administered as three standard doses one month apart (0, 1, 2-month group) in healthy     malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.      An additional, delayed sporozoite challenge will assess persistence of protection induced by     the primary immune schedule and if an additional dose can provide protection in those     unprotected by the initial vaccination series.   "
109108|NCT01857856|"     In the Netherlands ≈15% of idiopathic dilated cardiomyopathy (DCM) and ≈10% arrhythmogenic     right ventricular cardiomyopathy (ARVC) patients carry a single (founder) mutation in the     gene encoding Phospholamban, PLN R14del. Analogous to other inherited cardiomyopathies, the     natural course of the disease is age-related (age-related penetrance); after a     presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease,     and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum     Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+     homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The     investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with     eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a     strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.   "
109109|NCT01857843|"     Objective: To evaluate the early effects of intensive lipid lowering treatments with     ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques.      Study Design        -  Prospective, randomized, single-center study of each 80 subjects enrolled        -  Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will          be enrolled.        -  Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B)          Pravastatin (n=80), and each group of patients will be randomized further in a ratio of          1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used.        -  All subjects will undergo VH-IVUS at initial procedure.        -  Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial          procedure and 3-months will be performed in available cases.   "
109110|NCT01857830|"     The purpose of this research study is to examine whether a short term meditation intervention     can improve health, mood, and biological markers of cellular stress and aging in novice and     experienced meditators compared to controls.   "
109112|NCT01857804|"     The objective of this randomized controlled clinical trial is to evaluate the outcome of     treatment of peri-implantitis with or without systemic antibiotics.      Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on     the healing process, and (ii) the risk for recurrence of disease following surgical treatment     of peri-implantitis.   "
109113|NCT01857791|"     Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the     prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1     Although several pediatric weight management programs are available, access to these programs     may not always be possible.      The proposed study will be an ongoing research program with approximately 40 children ages     12-18 years enrolled into the study over a year. All study participants will participate in a     baseline evaluation which will include body composition measures, aerobic testing, as well as     nutrition and physical activity questionnaires. Study participants will be assigned to the     clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary     weight management program. All study participants will then participate in a 12-week     follow-up evaluation similar to the baseline visit. New participants will be enrolled every     12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12     weeks) will have the option to continue in the program or, discontinue their active     participation in the program and enroll into the maintenance phase which will consist of     measures only every 12 weeks.      The objective of the proposed study includes examining the efficacy of the clinic-based,     multi-disciplinary, pediatric weight management program.   "
109114|NCT01857778|"     There will be breast tissue changes after use of a breast pump.   "
109115|NCT01857765|"     The purpose of this study is to determine whether implementing a rehabilitation program can     improve the post-operative time to pain free living after breast augmentation.   "
109116|NCT01857752|"     Primary Objectives:        1. To investigate the response rate (complete response plus partial response) of          temozolomide for 8 weeks (2 cycles), in patients with retinoblastoma metastatic to the          central nervous system (mass only) in two strata:             -  A. Initial diagnosis (mass)             -  B. At relapse (mass)        2. To determine hematologic toxicity: absolute neutrophil count (ANC), platelets and          hemoglobin count.      Secondary Objectives:        1. To determine the response in other metastatic sites (non target) (orbit, bone marrow,          bone, lung, liver and others)        2. To determine the remission rate and time to relapse on temozolomide.        3. To document the response of leptomeningeal metastasis (cerebrospinal fluid) to          temozolomide   "
109117|NCT01857726|"     The aim of this study is to compare the efficacy of transarterial chemoembolization with     adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion     with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.   "
142766|NCT01415778|"     The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese     healthy male subjects.   "
109119|NCT01857700|"     Research questions: What effect does provision of food vouchers have on uptake of voluntary     medical male circumcision? What is the amount of food voucher that should be given?      Hypothesis: The percentage of men who are compensated for costs of travel to and lost wages     due to VMMC and who undergo VMMC will be higher than the percentage of men who are     compensated for lost wages or travel and undergo VMMC, and both of these percentages will be     higher than the percentage of men who are not compensated for travel or lost wage costs but     undergo VMMC.   "
109120|NCT01857687|"     To assess the feasibility of CT-derived computed fractional flow reserve (FFRCT), wall shear     stress and total plaque force on coronary atherosclerotic plaque and to collect the     preliminary data to apply those parameters for the prediction of clinical outcomes in     patients with coronary artery stenosis.   "
109121|NCT01857674|"     -  For patient in intensive care unit, extubation failure is defined as the necessity of          early reintubation after scheduled extubation, with Increased morbidity and mortality,          so it seems important to quickly identify patients with high risk of post-extubation          acute respiratory failure.        -  Major post-extubation laryngeal edema is one of extubation failure causes, and its          incidence vary in literature from 4 to 37%.        -  We can't currently predict arising of a major post-extubation laryngeal edema. However,          a recent pilot study showed that laryngeal ultrasonography could help to identify          patients with high risk of post-extubation stridor, measuring ultrasonic leak volume and          cuff-deflated air-column width, of which we propose to assess diagnostic performance.   "
109122|NCT01857661|"     The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a     digital new hearing aid with an integrated sound generator. These prototypes assist both     hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the     population).      Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the     development of devices for the hearing rehabilitation as well as the treatment of tinnitus     represents an advance in the implementation of Public Policies in Brazil.      The aim of this study is to compare the efficacy of the hearing aid with an integrated sound     generator and amplification alone for tinnitus control in patients with tinnitus associated     hearing loss.   "
109123|NCT01857648|"     The aim of this study is to test a methodology of counseling on physical activity among     Community Health Workers working within primary health care in Brazil.   "
109124|NCT01857635|"     In patients suffering from hypercapnic respiratory failure and treated by non invasive     ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and     PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will     be done during one-hour NIV treatments.   "
109125|NCT01857622|"     To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial     fibrillation patients with severe renal impairment, compared with DU-176b administered to     non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal     impairment (Normal/MiRI).   "
109126|NCT01857609|"     This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics     and pharmacodynamics of metformin in healthy Korean men.   "
109127|NCT01857596|"     The purpose of this study is to investigate whether Lorexys is effective and safe to treat     premenopausal women who have lost their sexual desire to a distressing degree.   "
109128|NCT01857583|"     To assess the safety and pharmacokinetics of DU-176b administered to patients with severe     renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b     administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of     the lower limbs.      For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of     the lower limbs will be compared with that of fondaparinux.   "
109129|NCT01857570|"     The purpose of this study is to evaluate whether standard volume computed tomography (CT) has     impact on treatment in patients with suspicion of fractures of the wrist and carpus.   "
109130|NCT01857557|"     This trial assesses the impact of a supervised aerobic exercise program by a kinesiologist in     patients with migraine. Patients can be assigned to one of two groups 1)The exercise group or     2)non-exercise group. This is a important area to study because there is currently limited     information regarding exercise and its impact on migraine frequency and severity. In many     cases, migraine patients are disabled by their headaches and sometimes will not have a     significant response to medications. As a result, it is important to study other     non-pharmacological interventions. In this study, the investigators hope to show the benefits     of exercise by a reduction in number of headache days per month as well as by improvement in     quality of life, disability,depression,anxiety,and aerobic fitness.This study will not     interfere with the usual treatment patients receive at our headache clinic and patients can     remain on medications deemed necessary.   "
109131|NCT01857544|"     The purpose of this study is determine the number of patients with complete resolution of     macular edema secondary to central retinal vein occlusion following 6 monthly injections of     Aflibercept.   "
109132|NCT01857531|"     The purpose of this research study is to evaluate whether the investigational drug ganaxolone     can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other     research studies) for the treatment of seizures and migraines. This drug is considered     investigational in the US.   "
109133|NCT01857518|"     Adolescence is a critical period for the development of depressive disorders. As adolescence     also is a critical period for brain maturation, it may be hypothesized that maturation     changes in emotional circuits could underlie vulnerability for depression.      The aims of the study are (1) to identify the changes in brain morphometry, white matter     microstructure, and functioning, in networks associated with depression features in     adolescents, and (2) to assess the effects of treated pathology on brain structure by     comparing the neuroimaging measures obtained in adolescents at inclusion with those at     follow-up.   "
109134|NCT01857505|"     The investigators propose to evaluate and compare the percentage of patients who are able to     be discharged in less than 3 days after undergoing total hip arthroscopy through either a     direct anterior or posterior approach, utilizing the identical post operative protocol. The     investigators also propose to evaluate the costs associated with the two different approaches     to hip replacement in the same group of patients. Post operative resource utilization,     discharge disposition, and pain medicine requirement will also be evaluated.   "
109135|NCT01857492|"     This study is testing whether the addition of a noninvasive form of brain stimulation called     transcranial direct current stimulation (tDCS) when combined with meditation helps decrease     the abdominal pain in patients with chronic pancreatitis. The device involved in this study,     transcranial direct current stimulation (tDCS) is investigational. This means that the study     device is still being tested in research studies and is not approved by the Food and Drug     Administration [FDA].   "
109136|NCT01857479|"     Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease     the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).   "
109137|NCT01857466|"     Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts     and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of     the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar     coagulation could result in the damage of ovarian reserve and decrease the response of the     ovaries to hormonal stimulation for assisted reproductive technologies. The possible     mechanism may contribute to thermal destruction of ovarian follicles by excessive use of     bipolar coagulation for hemostasis purposes.      To avoid additional ovarian tissue damage by conventional bipolar coagulation being     potentially important ovarian reproductive function, hemostasis using various topical     hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among     them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix     sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact with     blood after application at a bleeding site, the gelatin particles swell and tamponade     bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood     flow and providing exposure to a high thrombin concentration, thus hastening clot formation.     Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where     there is superficially pervasive focus of bleeding.      Ovarian reserve is defined as the functional potential of the ovary, which reflects the     number and quality of antral follicles left in the ovary, and is correlated with the response     to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone (AMH) has     been accepted as the most reliable and easily measurable marker for postoperative assessment     of ovarian reserve.      The investigators conducted a multicenter, large-scale, randomized controlled trial to     investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in     preserving ovarian reserve by assessing serial AMH levels in patients undergoing laparoscopic     ovarian cystectomy for benign ovarian cysts.   "
109138|NCT01857453|"     Adult medulloblastoma is a rare tumour.      The standard risk  group (complete surgery or residual tumour lower than 1,5 cm2, absence     of malignant cells in the cerebrospinal fluid, absence of metastasis, absence of MYC     amplification and exclusion of large cells medulloblastoma) concerns, for the adult     population, a majority of patients at diagnosis (about ¾ of cases).      Conventional treatment is classically based on a 54/36 Gy cranio-spinal radiotherapy (54 Gy     on the posterior fossa and 36 Gy on the nevraxis).      This treatment is associated with an acute toxicity (haematological, cutaneous, digestive and     general) wich decreases gradually when patient goes away from the treatment period.      For this category of patients and this modality of treatment, The French intergroup     experience, pleads in favour of a late and progressive neurotoxicity.      This neurotoxicity is associated with a clear degradation of the quality of life.      In the light of paediatric studies :      We propose a phase II study to estimate the interest of a decrease of radiation doses     compensated by a chemotherapy according to the following schedule        1. carboplatine + etoposide based chemotherapy every 28 days x 2        2. followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the in          toto neuro axis and 54 Gy on the post operative bed.      The majority of French centres concerned with the neuro-oncology are involved in this trial.      About 25 new cases by year are waited. A centralized analysis of pathological slides and of     the pre and post surgery Magnetic Resonance Imaging is foreseen.      The main objective is to estimate the survival without disease at 1 year      Secondary objectives associate the evaluations of the rate of complete response at the end of     procedure, the overall survival, the survival without disease, the survival without events,     the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the time until     definitive deterioration of the quality of life Associated studies      Two associated studies are besides foreseen (parallel search for co-financing):        1. A biologic study is planed with the aim to confirm, by morphological, genomic and          transcriptomic studies, the interest, for the adult population, of the prognostic          markers used in paediatric population        2. A radiological study is planed with the aim to estimate the interest :             -  of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature               detection of recurrences             -  of the study of functional connectivity in correlation with the neuropsychological               follow-up for the analysis of the aetiology and premature markers of neurotoxicity.   "
109141|NCT01857414|"     The aim of the the study is to investigate whether Remote Ischaemic Conditioning (RIC) can     improve clinical outcomes (cardiac death and hospitalisation for heart failure) at one year     in patients presenting with ST-elevation Myocardial Infarction and undergoing primary     percutaneous coronary intervention. This will be done in a multinational investigator-driven,     multi-centre, randomised, controlled, single-blind, parallel assignment, prospective clinical     efficacy trial.   "
109142|NCT01857401|"     There is currently no experimental model that accurately represents sarcoidosis. The lack of     a useful research model significantly slows progress towards developing new treatments for     sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will     test the model to see if it helps us understand how sarcoidosis develops and if it is useful     for testing new treatments.   "
109143|NCT01857388|"     Implementation of an adapted ParentCorps program in Ugandan schools will improve school     mental health service resources, teachers' knowledge about child mental health, and teachers'     classroom behavioral management and parent involvement skills.   "
109144|NCT01857375|"     This research is to determine the use of insulin pens compared to syringe and vial therapy in     adults newly begun on insulin therapy during their hospital stay.   "
109145|NCT01857362|"     The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg     capsules in healthy volunteers.   "
109146|NCT01857349|"     The goal of this study is to determine the superiority of surgical scrub preparations in     total knee arthroplasty based on the bacterial counts present on the skin surface and in the     deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub     preparation, post preparation after the application of the sterile drapes, deep joint tissue     sample prior to wound closure, and immediately post wound closure. This study will provide an     assessment of the management of sterility by comparing quantitative and qualitative cultures     immediately after surgical scrub preparation and the maintenance of sterility throughout the     procedure. This study will enhance prior research efforts by contributing quantitative     bacterial load and bacterial load within the surgical wound at closure.   "
109147|NCT01857336|"     Poor graft function (PGF) is a common complication after allogeneic stem cell     transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly     understood. Infusion of donor peripheral cell harvest was effective for some patients with     PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral     cell harvest for poor graft function.   "
144126|NCT01397903|"     The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in     patients with MDD who had an inadequate disease control with antidepressant medication.   "
109148|NCT01857323|"     This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of     the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The     purpose of this study is to evaluate the functionality, reliability, and accuracy of the     Albuterol Spiromax inhaler integrated dose counter in a clinical setting.   "
109149|NCT01857310|"     The overarching goal of this trial is to determine if an intervention comprising folic acid     and zinc dietary supplementation improves semen quality and indirectly fertility outcomes     (i.e., live birth rate) among couples trying to conceive and seeking assisted reproduction.     The following study objectives underlie successful attainment of the overarching research     goal:        1. To estimate the effect of folic acid and zinc dietary supplementation on semen quality          parameters, including but not limited to concentration, motility, morphology, and sperm          DNA integrity, relative to the placebo group.        2. To estimate the effect of folic acid and zinc dietary supplementation on fertility          treatment outcomes [fertilization, embryo quality, implantation/human Chorionic          Gonadotropin (hCG) confirmed pregnancy, clinical pregnancy, live birth], relative to the          placebo group.        3. To estimate the association between semen quality parameters, sperm DNA integrity and          fertility treatment outcomes (fertilization, embryo quality, clinical pregnancy, live          birth) and to identify the best combination of semen quality parameters for prediction          of clinical pregnancy and live birth.        4. To estimate the effect of folic acid and zinc dietary supplementation on fertilization          rates among couples undergoing assisted reproductive technology procedures, relative to          the placebo group.        5. To estimate the effect of folic acid and zinc dietary supplementation on embryonic          quality among couples undergoing assisted reproductive technology procedures, relative          to the placebo group.   "
109150|NCT01857297|"     This is a study to assess the immune (antibody) response and safety of the 2013/2014     formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.   "
109151|NCT01857284|"     Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical     effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.     The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of     UDCA, and has been approved by state food and drug administration in China for treatment of     cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the     treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,     double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of     patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total     bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or     UDCA for 24 weeks.   "
109152|NCT01857271|"     This phase II trial studies how well erlotinib hydrochloride works before surgery in treating     patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of     normal tissue that needs to be removed.   "
109153|NCT01857258|"     The objective of this study is to formulate and validate a green tea confection (i.e. gummy     candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular     function. The central hypothesis is that a green tea confection will protect against vascular     endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of     this application will be assessed by developing a green tea-containing confection, examining     its physiochemical properties and its inhibition of starch digestion, and then validating its     vasoprotective activities in healthy humans by assessing its blood glucose-regulating     activities.   "
109154|NCT01857245|"     Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S.     infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response     (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care     and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV     treatment delivered within large clinical trials leads to SVR or cure in over 70% of     genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are     as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will     develop drug resistance, but the optimal adherence level to minimize resistance is unknown.     If HCV treatment continues to be delivered within current models of care, most IDUs will not     only fail treatment and develop resistance, but may transmit resistant viruses to others. We     have previously developed a multidisciplinary model of HCV care which integrates on-site     primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate     agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive     HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our     DOT model, pegylated interferon is administered once weekly, if applicable, and one daily     dose of oral medication is administered at the methadone window. In our CGT model, patients     initiate HCV treatment within a once weekly treatment group which provides powerful social     support to mitigate fears of side effects, promote efficient education, and deliver weekly     injections, if applicable. It is unknown whether either model is better or more     cost-effective than standard on-site care.      PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited     from methadone clinics and randomized to one of three models of care: DOT; concurrent group     treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of     two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more     efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing     drug resistance; (2) To determine the incidence and factors associated with the development     of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each     model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among     HCV-infected IDUs.      PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be     recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will     be offered the choice of model of care (either standard on-site, DOT, or concurrent group     treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of     opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2)     to determine adherence rates over time in drug users (genotype 3 and genotype 1 /     IFN-ineligible) initiating a 24 week IFN-free regimen.      PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be     recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will     be offered the choice of model of care (either standard on-site, DOT, or concurrent group     treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of     opiate agonist treatment patients initiating treatment with oral DAA combination of     sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine     adherence rates over time in drug users.   "
109155|NCT01857232|"     Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received     cancer chemotherapy   "
109156|NCT01857219|"     To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up to     30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be     invited to complete the second, identical fMRI session about 3 months following completion of     the first session. Fibromyalgia subjects will complete their scans before and after a 12-week     Tai Chi intervention in collaboration with Tufts Medical Center.   "
109157|NCT01857206|"     Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents     4 to 17 years of age.   "
109494|NCT01852812|"     This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the     treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The     primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets     (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.   "
109158|NCT01857193|"     Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in     combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to     characterize the safety and tolerability of the combinations of everolimus + exemestane +     LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer      Dose Expansion part of the study: To characterize the safety and tolerability of the triplet     combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6     inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011     + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients     treated with prior LEE011 are not allowed in Group 3).   "
109159|NCT01857180|"     Laparoscopic surgery has become the standard approach to a vast variety of surgical     procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation,     amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a     different set of skills than in open access surgery. Acknowledging this, several     comprehensive curricula have been developed to teach basic skills as well as advanced     laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to     surgery no designated curricula have been developed to introduce medical students to the     technique of laparoscopic surgery.      Participation in an introductory curriculum in laparoscopic surgery results in improved     cognitive and technical performance compared to self-directed learning. The greater     homogeneity and fewer dropouts amongst those in the curriculum group suggest that a     structured curriculum is essential in ensuring standardization of clinically relevant     training. An introductory curriculum for medical students should be delivered in a structured     and standardized fashion prior to clinical exposure in order to maintain motivation and     enhance learning.   "
109160|NCT01857167|"     This study is to examine the change of fasting insulin, glucose, insulin sensitivity and     related traits in response to the six month treatment of omega-3 fatty acids, including fish     oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty     acids, will be selected as a controlled oil. The investigators hypothesize that omega-3 fatty     acids could improve insulin sensitivity and glucose metabolism in Chinese type 2 diabetic     patients.   "
109161|NCT01857154|"     The purpose of this study is to determine whether consuming calcium carbonate that has been     micronized is more effective than the traditional form of calcium carbonate in maintaining or     increasing bone mineral density in people who are currently taking bisphosphonates or other     bone-health medications.   "
109162|NCT01857141|"     The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved     postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist     and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a     useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural     dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.   "
109163|NCT01857128|"     The purpose of the study is to learn about the best way to treat pilonidal cyst wounds and     learn which type of bandage (or dressing) can help the wound heal faster after having     surgery.   "
109164|NCT01857115|"     This protocol is a phase I/II multicenter study designed to assess the safety and the     efficacy of the proposed combinations as up-front treatment in elderly Multiple Myeloma (MM)     patients.   "
109165|NCT01857102|"     The purpose of this study is to determine the benefits of fitting low astigmats with soft     toric contact lenses versus spherical contact lenses with regard to visual comfort,     eyestrain, fitting efficiency, and visual performance.   "
109166|NCT01857089|"     The aim of this study is to assess the intra and inter-subjects variability of the pressure     measurement cartography in healthy and well and able volunteers, sitting on a rigid base     during two hours.   "
109167|NCT01857076|"     There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical,     gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a     single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2     diabetes mellitus and obesity class I. In order to compare the effect of weight loss on     glycemic control among medical and surgical groups, and after 2 years of follow up, the     results of efficacy, safety and maintenance will be compared between the three groups.   "
109168|NCT01857063|"     This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of     Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis     of this study is that montelukast is superior to placebo in the treatment of nasal symptoms     in SAR.   "
109169|NCT01857050|"     Many drug interactions with Warfarin are well documented in the literature, including     interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict     when the interaction remains theoretical and when it becomes clinically significant and will     be reflected in the individual patient. This study's aim is to identify and characterize     related conditions (including comorbidities, laboratory test results and other parameters     related to the patient)that might be predictors for drug interactions turning from     theoretical to clinically significant.   "
109170|NCT01857037|"     Inclusion criteria:        -  Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after          radiation therapy for prostate cancer addressed for prostate biopsy OR        -  Patients referred to our institution for biopsy-proven local recurrence after radiation          therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number          of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of          recurrence)      Study Design:        -  Included patients will undergo an endorectal US examination with a Histoscanning™          acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic          contrast-enhanced) MRI.        -  Two independent operators will separately define suspicious focal lesion on          Histoscanning™ images and on MR images.        -  Random biopsies (at least 2 cores) will be performed in sextants negative at          Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI,          targeted biopsies will be performed in the suspicious part of the sextant (at least two          cores per suspicious lesion).        -  Histoscanning™ and MRI results will be compared to biopsy results.      A total of 30 patients will be included   "
118107|NCT01740024|"     The primary objective of this clinical trial is to quantify the loss of in vivo biological     potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the     native allergenic extract (N).   "
109171|NCT01857024|"     The primary objective of this study is to assess in a post-approval clinical setting the     safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult     hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum     phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of     Product Characteristics (SmPC) and followed according to the investigator's standard clinical     practice management. Each patient will be followed up for 12 months or up to the time they     start dialysis, whichever occurs first.   "
109172|NCT01857011|"     The purpose of this study is to determine whether intravenous or oral iron are effective in     the treatment of postoperative anemia and iron deficiency in patients submitted in     postbariatric abdominoplasty.   "
109173|NCT01856998|"     The purpose of this study is to evaluate the therapeutic equivalence, based on     pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL     (AstraZeneca), administered by target controlled infusion (TCI).   "
109174|NCT01856985|"     These pilot studies are designed as open label studies to investigate the acceptability of     200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered     buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in     gestations 78-84 days' LMP. They will be done consecutively.      Findings from the pilot studies will guide the development of a larger, multi-site study to     investigate the efficacy of outpatient medical abortion regimens for women with gestations     from 78 - 84 days LMP. In that end, the pilots seek to collect information on the     acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed     by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable?     Women's rating of the tolerability of any side effects will also be documented.   "
109175|NCT01856972|"     This study will examine the short term effects of adding manual therapy techniques to static     stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2     forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument assisted     soft tissue mobilization (IASTM). By comparing 3 groups: TJM+static stretching versus IASTM +     static stretching versus static stretching alone the investigators wish to see if there are     any short term benefits in DF ROM by adding either of these interventions to static     stretching.      The manual therapy treatment will occur over 2 sessions and DF ROM measurements will be taken     4 times over a 2 week period.      The population that the investigators wish to examine are subjects with healthy feet and     ankles, but with limited DF ROM.      The primary objective of this study is to see if subjects with decreased dorsiflexion motion     will experience greater increases in dorsiflexion motion with the addition of manual therapy     of static stretching alone.      Our hypothesis is subjects who receive manual therapy therapy and static stretching will     experience a significant increase in DF ROM as compared to subjects who receive static     stretching alone. More specifically subjects who are treated with the IASTM will experience     greater results than subjects who are treated with the rear-foot thrust mobilization.   "
109208|NCT01856543|"     The purpose of this study is to find out if the effect of mometasone furoate is any different     from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing     the skin from peeling, or reducing the amount of irritation the patient reports during     treatment.   "
109324|NCT01855035|"     The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring     after ischemic stroke results in a higher detection of atrial fibrillation (/flutter)     compared to usual care (at least 24 hour of cardiac monitoring).   "
110220|NCT01843296|"     The purpose of this study is to Compare three methods of intrathecal bupivacaine;     bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and     postoperative pain in patients undergoing lumbar disk herniation surgery.   "
109176|NCT01856959|"     As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered     intravenously in the treatment of the patients with acute severe asthma not responding to     conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted     in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of     intravenous MgSO4 administered is not common in clinical practice, because it's prone to have     adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension,     decreased tendon reflexes and so on with this treatment. The aerosolised route offers the     advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle     and lower incidence of side effects when compared to the intravenous route. At present, there     are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma     in children, and the conclusions are controversial.   "
109177|NCT01856946|"     Childhood obesity is a rapidly growing epidemic in the US and the world. Current estimates     suggest that 30% of our nation's children are either overweight ot obese. Obesity is a major     risk factor towards the development of insulin resistance, which, in turn is a major risk     factor for the development of type 2 diabetes. Prior research has suggested that vitamin D     therapy may be a safe, inexpensive, and effective method of reducing insulin resistance and a     person's risk of developing diabetes.      The investigators' prior studies have shown that daily 4,000 IU vitamin D therapy is a safe     and effective method of improving insulin resistance based on a calculation called the     HOMA-IR.      The next step in identifying whether vitamin D truly improves insulin resistance is to use     oral glucose tolerance testing (OGTT), which is a better real-life measure of insulin     resistance compared to the previously used HOMA-IR.   "
109178|NCT01856933|"     The purpose of this study is to evaluate the effectiveness of Prostate Specific Membrane     Antigen (PSMA ADC), as well as its safety and side effects for patients with advanced brain     tumors. This study will also study how your body metabolizes (breaks down) PSMA ADC.   "
109179|NCT01856920|"     Background:      - GI-6207 is an experimental cancer vaccine made with baker's yeast. The yeast has been     modified to help the immune system target a protein called CEA. CEA is found on the surface     of some kinds of tumor cells, including thyroid cancer cells. Researchers want to see if     GI-6207 can encourage the body's immune system to attack and kill tumor cells that contain     the CEA protein. They will test to see whether this vaccine is a safe and effective treatment     for medullary thyroid cancer that has not responded to earlier treatments.      Objectives:      - To test the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid     cancer.      Eligibility:      - Individuals at least 18 years of age who have medullary thyroid cancer that has not     responded to earlier treatments.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide blood and tumor samples and have an imaging study of the neck and chest. They          will also have a skin test to make sure that they are not allergic to the yeast in the          vaccine.        -  Participants will be divided into two groups. One group will start to take GI-6207          immediately for 1 year. The second group will have 6 months of monitoring and tests with          no vaccine, and then will take GI-6207 for 1 year.        -  GI-6207 will be given every other week for the first seven visits (about 3 months), and          then monthly for the remaining year of treatment. It will be given as injections beneath          the arm and in the upper thigh. These locations will help the vaccine enter the lymph          nodes and reach the immune system more quickly.        -  Participants will be monitored with frequent blood and urine tests and imaging studies.        -  Participants will have regular follow-up visits after their year of study vaccines.   "
109232|NCT01856231|"     The purpose of this preliminary study is to examine the effects of a program that includes     two-months of structured lab-based training. The proposed study will examine the effects of a     lifestyle physical activity intervention designed to increase PA in people with moderate and     severe COPD. The intervention includes a combination of (a) structured laboratory-based     exercises with a behavioral intervention, (b) structured home-based exercises and (c)     lifestyle physical activities performed at home. The subjects will be followed for a total of     18 weeks.   "
109181|NCT01856894|"     In this study the investigators aimed to investigate whether there is a relation between body     weight and serum anti mullerian hormone levels in adults with polycystic ovary syndrome. For     this purpose the investigators designed a prospective study including three groups. The group     I is defined as adults with polycystic ovary syndrome and body mass index is greater than 25.     The group II is defined as adults with polycystic ovary syndrome and body mass index is less     than 25. The group III is defined as adults with non-polycystic ovary syndrome and body mass     index is less than 25. The all three groups are compared considering their serum AMH     levels,lipid profiles, sex steroids and glycemic analyses.   "
109182|NCT01856881|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics following ascending multiple doses of AMG 876 in subjects with type 2     diabetes.   "
109183|NCT01856868|"     (-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired     skeletal muscle function in Becker Muscular Dystrophy (BMD) patients.   "
109184|NCT01856855|"     This study will investigate the safety, tolerability, and effectiveness of giving a higher     dose to the part of the prostate which contains the cancer while giving a standard radiation     dose to the entire prostate. The investigators have hypothesized that this treatment     technique will effectively control the prostate cancer while minimizing the side effects.   "
109185|NCT01856842|"     AVMs are abnormal collections of blood vessels which can occur in any part of the body     including the lungs. These blood vessels are weakened and can rupture anytime causing     bleeding which can be massive, leading to life-threatening conditions.      Pulmonary AVMs occur in about 40% of patients with HHT. Each patient may have an average of 5     AVMs .Rupture of the AVM can lead to massive bleeding in the lung, stroke and infection of     the brain. In order to prevent these complications, patients with HHT are routinely examined     for pulmonary AVMs and treatment with embolization is recommended.      AVMs have a main blood vessel or artery supplying blood to the collection of blood vessels.     The way to treat AVMs is cut off their blood supply through a process called embolization.      Embolization is a standard medical procedure which is done to stop or prevent hemorrhage     (bleeding) from an AVM. It involves blocking the artery that supplies blood to the AVM by     inserting a foreign body, into the blood vessel supplying blood to the AVM.      Standard devices used for embolization include coils (made of stainless steel or platinum).     These devices usually have a good success rate for blocking the artery that supplies blood to     the AVM. However, a few AVMs that are embolized by standard devices may reopen over time.     This is called reperfusion and will require repeat embolization procedures.      For embolization of pulmonary AVMs at St. Michael's Hospital, the Nester coil is used. In     this study, we would like to compare the Nester coil with a new coil device called the     Interlock Fibered IDC Occlusion System. Both coils are approved for use in Canada, however     the cost of the IDC coil limits its use at this hospital.      Compared to the Nester coil, the IDC coils are made so that they can be removed or     repositioned if they are not placed correctly. The coil also allows tighter packing which     helps prevent reperfusion.      This study will compare the success rate of embolization between the Interlock™ Fibered IDC™     Occlusion System (IDC coil) and the Nester coil.   "
109325|NCT01855022|"     The primary purpose of this study is to determine the effectiveness of a hospital-based     intervention, using motivational interviewing and interactive voice response (IVR), to reduce     hospital readmissions within 90 days of enrollment compared to usual care, for patients with     heart failure and chronic obstructive pulmonary disease.   "
120960|NCT01702649|"     RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat     bacterial infections, including those due to multi-drug resistant bacteria.   "
109186|NCT01856829|"     Omega 3 in the form of phospholipids are the main component of nerve cells and their oral     intake is known to have a positive impact on behavior disorders such as depression or bipolar     disorder. Their consumption would improve brain function while increasing the ability to     concentrate. The study aims to determine the effect of an increase in Omega 3 in the form of     phospholipids on the processing of visual information in the brain and in particular the     attention and perceptual-cognitive learning in a three dimensions environment. Eighty     subjects (40 young (18-35 years) and 40 older (60-75 years)) divided into four groups, two     Omega-3 (20 young and 20 older) and two other placebo (20 young and 20 elderly ), will in     this study, performing a complex perceptual-cognitive task such as the pursuit of moving     objects in a 3D space. This stimulus was chosen because it is very similar to the situations     of daily life, but also because it involves a mechanism of perceptual-cognitive level. The     main objective is to demonstrate the positive effect of Omega-3 phospholipids on the     perceptual-cognitive training.   "
109187|NCT01856816|"     The purpose of this research study is to determine how different meal patterns influence the     absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that     carotenoid absorption will be lower when daily vegetables are consumed in one meal compared     two smaller meals throughout the day.   "
109188|NCT01856803|"     Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen     (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of acute     GVHD is significantly higher in patients at 40 years of age or more than those at 18 to 39     years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used for     prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG in     patients at 40 years of age or more in matched sibling allo-SCT settings might significantly     decrease the incidence of acute and chronic GVHD and the incidence of late effect after     transplantation.   "
109189|NCT01856790|"     Closed loop artificial pancreas systems have been under development for the control of     blood sugars in those living with diabetes. These systems consist of a continuous glucose     sensor, which sends a signal to a computer program that automatically determines how much     insulin to give. The computer program then tells an insulin pump to deliver the insulin.     While such systems have been tested under a number of conditions, post-meal blood sugars are     difficult to control. This study is designed to see if liraglutide, a glucagon like peptide     receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1     diabetes while they are on a closed loop system.   "
109190|NCT01856777|"     This randomized study will examine the effectiveness of two types of pregnancy tests (a     semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home     at various time points after early medical abortion. The first test a semi-quantitative panel     test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based,     one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a     locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San     Diego, CA, USA).        1. The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly          identify ongoing pregnancy at day 14.        2. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly          identify ongoing pregnancy at day 7.        3. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly          identify ongoing pregnancy at day 4.   "
109191|NCT01856764|"     The purpose of this study is to evaluate the effect of topical roflumilast on the reduction     of atopic dermatitis lesions in adults with atopic dermatitis.   "
109192|NCT01856751|"     Occurrence of inhibitors to coagulation factor VIII is diagnosed in ~30% patients with     haemophilia A. Presence of inhibitor with a titre >5 BU/ml requires the use of by-passing     agents: recombinant activated Factor VIIa concentrate (rFVIIa) and/or activated prothrombin     complex concentrate (APCC). Similarly, haemorrhagic complications in patients with acquired     haemophilia and inhibitor titre >5 BU/ml should be treated with by-passing agents.      Response to treatment with by-passing agents is patient-specific, and can vary in the same     patient during subsequent bleedings. Some patients have good response to both products,     however in other patients a better bleeding control is provided by one of the mentioned above     agents (APCC or rFVIIa). There are clinical situations when severe bleedings requires an     alternate use of both these agents.      Traditional methods of laboratory tests used post-treatment in patients with haemophilia     without inhibitors are useless in the presence of inhibitor. Laboratory monitoring of therapy     with by-passing agents is possible with the use of global tests for the coagulation process     assessment, which are as follows: thrombin generation assay (TGA) and thromboelastometry     (TEM).      Several studies revealed that TGA allows a monitoring of therapy with by-passing agents in     patients with haemophilia A and inhibitor - the choice of the most effective treatment option     - agent type and its dose, as well as laboratory assessment of treatment efficacy.      Up to date, laboratory tests assessing the efficacy of by-passing agents in patients with     acquired haemophilia were not conducted.      In Factor VIII or IX deficiency conditions, fibrin's fibres generated by thrombin are     morphologically thicker, and blood clots have increased susceptibility to fibrinolytic     enzymes. Blood clot stability may be assessed with the use of thromboelastometry (TEM). We     can hypothesize that simultaneous use of TGA and TEM methods may allow for an assessment of     patient's individual response to therapy with by-passing agents. Clinical significance of the     minimal dose of APCC and rFVIIa, needed to TGA and TEM normalization, requires further     studies.      Tests' purpose: Examination of the hypothesis that simultaneous use of thrombin generation     assay (TGA) and thromboelastometry (TEM) may facilitate the choice of optimal therapy with     by-passing agents and laboratory monitoring of efficacy of those agents in patients with     acquired haemophilia or haemophilia A with inhibitor.   "
109193|NCT01856738|"     Rationale: Visual hallucinations (VH) are the most common non-motor symptoms in Parkinson's     disease (PD). As an independent predictor for cognitive decline and nursing home placement     they form an important disability milestone in the course of PD. According to current     clinical guidelines minor VH do not require treatment per se. But as minor VH precede the     stage of major VH without insight and PD associated psychosis (PDP) they offer an opportunity     for early intervention. Neuroleptic drugs delay the transition into PDP but are unsuitable     for early treatment of VH due to their side effects. We hypothesize that cholinesterase     inhibitors (ChEI) are a well-tolerated alternative for the early treatment of minor VH to     delay the progression to PDP, and that brain network analysis is suitable to predict     treatment response.      Objective: Investigate whether early treatment with ChEI delays the progression of minor VH     to major VH without insight or PDP. In addition, we will measure motor control, psychotic     symptoms, cognitive impairment, mood disorders, daytime sleepiness, adverse events and     compliance, disability, caregiver burden and care use. We assess the cost-effectiveness of     early chronic treatment of VH with ChEI. Finally, we analyse changes of functional brain     networks before and during treatment.      Study design: A randomized, double blind, placebo-controlled, multi-center trial with an     economic evaluation.      Study population: 168 patients with PD and VH after fulfilling the in-and exclusion criteria.      Intervention: Rivastigmine capsule 6 mg BID or placebo BID for 24 months.      Main study parameters/endpoints: The primary outcome measure is the median time until PD     patients with minor VH progress to major VH without insight. The clinical endpoint is defined     as the start with antipsychotic treatment. Secondary outcome measures are changes in motor     control, psychotic symptoms, cognitive impairment, mood disorders, daytime sleepiness,     cholinergic deficiency, the number of adverse events, compliance, disability and caregiver     burden. The median time until PD patients with minor VH progress to PD dementia is measured     by means of changes in cognitive function. The secondary neurophysiological outcome measures     are peak frequency, functional connectivity, topological network organisation and the     direction of information flow. All relevant costs will be measured and valued.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The burden of participation consists of a total of 5 clinical visits (every 6     months), 5 telephone interviews on adverse events during the escalation phase and 9     questionnaires on health related costs (every 3 months). In a subgroup 3 additional visits     for EEG recording are needed. There is a risk for adverse reactions with rivastigmine     treatment; the most common are nausea and vomiting.   "
109195|NCT01856712|"     The over-arching goal of the proposed project is to understand the impact of medication     adherence upon engagement in behavioral treatment for alcohol use disorders. The proposed     project is a pilot feasibility study of inpatient veterans with problem alcohol use at the     William S. Middleton VA Hospital (Madison, WI). Participants will be randomized to one of two     parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital     discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg     intramuscular injection of naltrexone administered prior to discharge and a second injection     one month later. The central hypothesis is that hospital-administered injectable naltrexone,     when compared to daily oral naltrexone taken at home, will reduce alcohol use in the days     immediately following hospitalization. Injectable naltrexone has been efficacious vs. placebo     in addition to behavioral treatment in several studies. However, it has yet to be examined in     head-to-head comparison with oral naltrexone, or in the hospital setting as an intervention     that might facilitate behavioral treatment follow up after discharge.   "
109196|NCT01856699|"     Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of     cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a     primary focus on future stroke and mortality.   "
109197|NCT01856686|"     Multicenter, Prospective, randomized, comparative and controlled study about the beneficial     effects in behavior and brain connectivity of different dietary patterns in 100 children with     ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.   "
109222|NCT01856361|"     This is a randomized controlled trial to evaluate the effect of ramipril in stimulating and     promoting sperm production in men with low sperm count. Ramipril is an Angiotensin Converting     Enzyme Inhibitor (ACEI) currently used to treat high blood pressure. However, previous     studies have shown that this class of medications can improve sperm parameters. The purpose     of this study is to evaluate the efficacy of ramipril compared to placebo (Substance That is     not known to have treatment effect), in improving sperm density in infertile men with     documented low sperm count. This study will help us identify subjects that might benefit from     treatment with this medication, and the effect it will have on sperm count, shape, and     motility.   "
109223|NCT01856348|"     The study is conducted to assess the effect of a vitamin D3 supplementation on the activities     of two intestinal transporters and on the pharmacokinetics of the transporter substrates     folic acid and fexofenadine.        -  Trial with medicinal product   "
109198|NCT01856673|"     This study is a community prevention randomized trial with three parallel groups: two     intervention groups and one control group in Buenaventura and Quibdó.      The aim of the trial is to evaluate the impact of two community interventions on mental     health; the intervention groups are designed to decrease depression, anxiety, post-traumatic     stress disorders symptoms as well as the level of dysfunctionality in Afro-Colombian victims     of violence.      Adult people (equal or more than 18 years old) belonging to Afro-Colombian communities in     both cities will participate in the enter survey. The subjects will be selected based on the     severity of symptoms, traumatic experiences and a level of dysfunction identified using the     instruments of this research (i.e. those obtaining an score equal or higher than 49 in     symptoms (25% of the total of symptoms)).      The fieldwork and the interventions will be conducted by people belonging to the community;     they are called Lay Psychosocial Community Workers (LPCW). After six (6) weeks of formal     training, they will be able to perform two kinds of interventions, Common Elements Treatment     Approach (CETA) based on a cognitive behavioral intervention and Narrative Community Group     Therapy (NCGT), for the people affected by violence and displacement that were pre-selected     according to the baseline instrument.      The LPCW will be under the constant supervision by psychologists of the project, and under     weekly supervision by a group of experts from Johns Hopkins University, the Heartland     Alliance and The Institute for Research and Development in Violence Prevention and Promotion     of Peaceful Coexistence Social (CISALVA) by means of phone calls or monthly visits to the     cities. Selected subjects will be randomly allocated to any study branch: CETA, NCGT or the     waiting control group.      The study subjects will follow their allocated treatment, or waiting in the control group,     for 8 to 12 weeks; then they will be re-assessed using the project instrument two weeks after     the last session of therapy.      The study outcome is the differences in instrument scores between the follow-up and the     baseline among the interventions (CETA or NCGT) and control group.      Control subjects will be assessed by the project psychologist after the follow-up, and they     will receive treatment when necessary.   "
109199|NCT01856660|"     Individual food preferences are not considered in designing weight-loss therapies. This     project will determine if short-term weight-loss is improved by matching participants with     diets that reflect their genetically-determined food preferences.   "
109200|NCT01856647|"     Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and     risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular     disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose     tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene     expression will enable us to identify inflammation in this tissue and may help us to     understand the causes and consequences of obesity in order to determine how these cells might     be implicated in the initiation and/or progression of the aforementioned diseases.   "
109201|NCT01856634|"     The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent     to the adult dose already shown to be effective against multidrug-resistant tuberculosis.   "
109202|NCT01856621|"     The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler     with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.   "
109203|NCT01856608|"     Assessing the utility of the Team SA instrument in measuring the effectiveness of     communication across disciplines during ICU rounds.   "
109204|NCT01856595|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple ascending doses of PF-06291874 in Type 2 Diabetes patients.   "
109205|NCT01856582|"     The purpose of this study is to determine if infusing additional special donor cells will     help to improve graft or immune function in previously transplanted children with immune     deficiencies and bone marrow failures.   "
109206|NCT01856569|"     Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients     with predominant assial involvement with 4 anti-TNF.   "
109207|NCT01856556|"     The primary objective of this study is to evaluate the safety and tolerability of a single     intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and     severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis,     changes in physical examination findings and subject-reported symptoms.      The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF)     pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal     elimination through urine concentration of NRX-1074 through 24 hours following dosing.   "
112082|NCT01818856|"     Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be     affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues     (NRTIs) in HCV/HIV-co-infected patients.   "
109209|NCT01856530|"     The purpose of this study is to learn more about how the hormone, oxytocin, impacts social     behavior in terms of cooperation with others, attention processing, and reward processing,     among patients with social anxiety disorder. Based on available research, the investigators     predict that in patients with social anxiety disorder, oxytocin will improve social     cooperation during an online ball-tossing game called Cyberball, reduce attention toward     socially threatening cues during a dot-probe task, and lead to greater willingness to work     for monetary rewards for others rather than themselves during an effort expenditure task.   "
109210|NCT01856517|"     The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous     noradrenaline. The working hypothesis is that the higher the plasma concentration of     endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline     will be. This will be tested in patients presenting with septic shock, following state of the     art management (including repeated assessment of vena cava diameter and compliance, and     response to dynamic indices of loading) following placebo vs clonidine administration (1     mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline     (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).   "
109211|NCT01856504|"     To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected     improvements in image quality and diagnostic accuracy.   "
109212|NCT01856491|"     The objective of this study is to gather data to establish the chronic safety, performance     and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.   "
109213|NCT01856478|"     This randomized, open-label, phase III study will be performed in patients with recurrent     and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The     objectives of this trial are to compare the efficacy and safety of afatinib versus     methotrexate.   "
109244|NCT01856075|"     This is an international observational multicentre study to be conducted in Germany, Spain,     Italy and USA. The main objective of the study is to evaluate the relative effectiveness of     dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest.     The design of the study is a historic-prospective cohort with dynamic exposure and stratified     competitive recruitment with balanced comparison groups of dronedarone versus alternative     antiarrhythmic drugs of interest.   "
109214|NCT01856465|"     Non-alcoholic fatty liver disease (NAFLD) includes benign hepatic simple steatosis (SS) and     steatohepatitis (NASH), which is characterised by inflammation leading to fibrosis and     cirrhosis. NAFLD is the hepatic manifestation of the metabolic syndrome, and the prevalence     is 74-98% in morbidly obese individuals undergoing bariatric surgery. Although steatosis     improves post bariatric surgery, hepatic inflammation and fibrosis do not consistently     improve. Alterations of the human gut flora (intestinal microbiota; IM) may play a role. One     mechanism linking IM to obesity, insulin resistance (IR), and NAFLD is through translocation     of bacterial lipopolisaccharide (LPS=endotoxin) into the blood stream (=endotoxemia), causing     chronic inflammation. Morbidly obese subjects have different IM compared to lean controls,     and the IM structure is significantly altered after bariatric surgery, probably due to a     combination of anatomic changes, diet, and weight loss. For example, the ratio of     Firmicutes/Bacteroidetes may be lower in obese subjects compared to lean controls and lower     numbers of Faecalibacterium prausnitzii were reported in some obese subjects before bariatric     surgery, which increased 3 months post-surgery. This is of interest since, in animal studies,     low abundance of F. prausnitzii, a butyrate producing bacterium, is associated with increased     intestinal permeability, endotoxemia, and inflammation. To our knowledge, only two studies     are available describing IM in patients pre and post bariatric surgery, and no data have been     published on the relationship between IM and NAFLD in these patients.   "
109215|NCT01856452|"     Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It     provides the surgeon the evidence of axillary lymph node metastasis, which determines the     extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node     dissection, it is increasingly important. In general, radioactive colloid has been used for     SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method     enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.      In this study, our hypotheses are as following:        1. Multimodal method enables to increase identification rate of SLNB        2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better          outcome        3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an          identification strategy   "
109216|NCT01856439|"     The study is designed to assess the long term tolerability of ProSavin and whether it is safe     and efficacious in patients administered ProSavin from the PS1/001/07 study .   "
109217|NCT01856426|"     The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV     gentotype-1 in chronically infected subjects and to further evaluate the safety profile of     EDP239.   "
109218|NCT01856413|"     Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure     require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved     preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral     antiviral medication. In the first 6 months after liver transplantation, patients receive     treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody     concentrations above 100 IU/L, the level considered safe for preventing hepatitis B     reinfection.      Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the     'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver     transplantation for hepatitis B induced liver failure'. The purpose of this study is to show     that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can     prevent hepatitis B reinfection.      Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of     patients and is more convenient for patients compared to intravenous treatment that must take     place in the hospital setting.      Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy     and Spain. Patients who are eligible for the study will receive treatment with Zutectra for     24 weeks.      During the study, the safety and effectiveness of Zutectra will be assessed by checking for     symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs     antibodies and hepatitis B surface antigen (HBsAg).   "
109219|NCT01856400|"     There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in heart     muscle. This gene is also found in blood vessels and skin tissue. When active this gene     builds a crucial protein inside the heart muscle called SERCA2a protein. This is responsible     for regulating calcium levels inside your heart muscle. When this gene is not activated,     studies have shown that it can lead to abnormal electrical currents in the heart that can     lead to death. The investigators are conducting this study to prove that SERCA2a gene is     inactive in patients with kidney disease. Scientists found that patient at risk for abnormal     electrical currents in the heart can be tested by what they called microvolt Twave     alternans. This is a very delicate machine much more sensitive than a regular     electrocardiogram that you do at the cardiology office.   "
109220|NCT01856387|"     Neutrophil/lymphocyte ratio (NLR) is a marker of systemic inflammation and endothelial     dysfunction. In recent years, it has been reported that the individual components of the     differential white cell count, specifically the neutrophil and lymphocyte counts,may have     clinical utility in predicting diseases. An elevated NLR has been shown to be a prognostic     indicator in various malignancies. İn the literature, many studies have been shown that NLR     have predictive value in determining the prognosis of various diseases (cardiac or noncardiac     diseases ). However, little is known about the predictive values of NLR in pregnancy     complications. This study aimed to evaluate the potential predictive value of NLR in     preeclampsia- eclampsia.   "
109221|NCT01856374|"     This study is a prospective open-labeled, randomized study to compare the neointimal coverage     at 3 months and 12 months and its serial changes between 3 months and 12 months according to     the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial     coronary artery and left main artery including the assessment of fibrous cap thickness and     lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the     changes such as plaques and neointimal coverage from serial OCT follow-up according to the     different statin strategy.   "
109245|NCT01856062|"     The purpose of this study is to determine if the addition of dexamethasone to clomiphene     citrate will increase the pregnancy rate of intrauterine insemination (IUI) cycles.   "
112541|NCT01812863|"     The purpose of this study is to determine if US-guided supraclavicular anesthetic blocks     reduce postoperative pain, use of rescue medication, and improve functional outcomes in     children who underwent surgery for supracondylar humerus fractures.   "
109224|NCT01856335|"     Study Population      -People with seizures benefit from regular exercise. Exercise may help decrease the number of     seizures they have. It also improves overall health and quality of life. However, people with     seizure disorders often have been prevented from doing sports or other regular physical     activity. They may also feel that exercise or injury can increase their risk of seizures.     Researchers want to try an exercise program for people who have seizures to see if they can     increase motivation to exercise which will improve overall health and may decrease the     frequency of seizures.      Objectives:      - To see how exercise education improves motivation to exercise in people who have a history     of seizures.      Eligibility:      - Individuals at least 18 years of age who have a history of seizures.      Design:        -  This study involves three outpatient visits and weekly telephone calls for about 12          weeks. There will be followup calls at about 6 and 12 months after the outpatient          visits.        -  Participants will be screened with a physical exam and medical history. They will answer          questions about their current level of physical activity, mood, quality of life, and          ideas about exercise.        -  At the first visit, participants will learn how to keep a physical activity log and          seizure calendar. They will also use an activity monitor and take their pulse regularly.          They will complete questionnaires about their mood and thoughts about exercise and          seizures.        -  At the second visit, participants will set personal activity goals and learn about          physical activity and seizures. They will review the physical activity log, seizure log,          and activity monitor and pulse readings for the previous 4 weeks.        -  After the second visit, participants will receive weekly telephone calls. Each call will          last about 5 minutes. These calls will ask about physical activities for the week and          participants' progress toward meeting their goals. These calls will also review the          seizure log.        -  At the third visit (12 weeks), the same tests from the first visit will be repeated.        -  The followup phone calls will continue to monitor participants' activity levels.   "
109225|NCT01856322|"     Background:      - Some types of inflammation may increase the risk of cancers in the intestinal track.     Because of this possibility, anti-inflammatory drugs may be able to prevent tumor growth and     spread. One such drug, sulindac, may be helpful to study. Researchers want to see if people     who are having surgery to remove intestinal tumors from advanced colorectal cancer will     benefit from sulindac. It will be tested against a placebo.      Objectives:      - To see if sulindac can improve treatment outcomes in people who are having surgery for     advanced colorectal cancer.      Eligibility:      - Individuals at least 18 years of age who are having surgery for advanced colorectal cancer.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. Imaging studies and heart and lung function tests may also be given.        -  Participants will be separated into two groups. One group will take sulindac. The other          will take a placebo.        -  Participants will take sulindac or placebo twice daily from about 2 to 3 weeks before          the scheduled surgery. Seven days before the surgery, they will stop taking the pills.        -  Participants will have surgery to remove their tumors. The surgery will also remove          affected organ tissue.        -  Participants will start to take the pills again once they have recovered from surgery.          They will continue taking the sulindac or placebo twice a day for 3 years, or for as          long as the tumors do not return.   "
109226|NCT01856309|"     The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136     (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment     with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.   "
109227|NCT01856296|"     An open non-randomized study using biology driven selection of therapies. WINTHER study will     explore matched tumoral and normal tissue biopsies and will use a novel method for predicting     efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all     (100 %) patients enrolled in the study, harboring oncogenic events (mutations/     translocations/ amplifications, etc.) or not. The total number of patients treated in the     study will be two hundred across all participating cancer centers (European countries     -France; Spain-, Israel, USA and Canada). All centers will realize the same study     independently.   "
109228|NCT01856283|"     This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients     with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells     (CD34+/lin-) in BM during nilotinib treatment.      In addition, in this study the investigators aim to perform Gene Expression Profiling (GEP)     of CML enrolled patients using Affymetrix GeneChip Instruments and Software Systems, and     Affymetrix GeneChip Human Genome U133 Plus 2.0 (whole human transcriptome analysis) at     diagnosis and at 3 different time points during treatment with Nilotinib (after 3, 6, 12     months).   "
112392|NCT01814800|"     This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous     infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary     Immunodeficiency Diseases (PIDD).   "
109229|NCT01856270|"     The investigators propose to conduct a 2-arm, open-label pilot study to determine if early     treatment with amitriptyline will decrease the frequency and severity of headaches after mild     traumatic brain injury (TBI). Amitriptyline is a tricyclic antidepressant that is commonly     available and inexpensive. It is used as a first-line drug for primary headache prevention in     a very low dose range of 10-50 mg.        -  Specific Aim 1 is to conduct a 2-arm open-label study to examine the effect of          preventive treatment with amitriptyline on the frequency and severity of headache after          mild TBI.        -  Specific Aim 2 is to collect data needed for design of a Phase 3 study, including an          estimate of effect size, headache variability, and desirable drug treatment start date.        -  Specific Aim 3 is to examine the feasibility of using headache diaries with individuals          with mild TBI.        -  Specific Aim 4 is to establish the safety and tolerability of amitriptyline for the          prevention of headache after mild TBI.      The investigators hypothesize that early preventive treatment with amitriptyline will avert     the development of chronic post-traumatic headache (PTH) as compared to rates of headache     from a recent natural history study on PTH after mild TBI.      The investigators propose to enroll inpatient subjects from a Level I trauma center as well     as from outpatient clinics and from the general community with a diagnosis of mild TBI.     Subjects will be screened for current headache. After baseline assessment, 72 subjects with     current headache will be randomized to one of 2 groups. Group 1 will immediately begin     amitriptyline and or Group 2 will be followed and begin amitriptyline at Day 30. All subjects     will be asked to complete a daily headache diary beginning on Day 1 of the study. A detailed     medical history and headache survey will be completed. Subjects will have a scheduled stepped     increase in the drug dosage every week for 3 weeks to the maximum study dosage of 50 mg.     Weekly telephone calls will monitor for adverse events and compliance with the drug and     headache diary. Clinic visits will occur at 30, 60 and 90 days. The 30 day clinic visit will     include cognitive testing to assess for differences between groups and initiation of drug     treatment for Group 2. Both 30 and 60 day visits will include review of headache diary,     potential adverse effects, and pill counts. The 90 day visit will be for outcome assessment.     In addition, the headache survey will be repeated by telephone at Day 180.   "
109230|NCT01856257|"     The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of     improving long-term graft function without increasing the risks of immunologic graft injury     by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.   "
109231|NCT01856244|"     Persons with Morbus Parkinson commonly develop gait and balance disorders leading to     dependence, loss of mobility and a high risk of falling.      This study investigates the effectiveness of a sensorimotor treadmill intervention to improve     walking and balance abilities in persons with early stages of Parkinson's disease. The     sensorimotor treadmill training is conducted on a special treadmill device which is     challenging the participants by small oscillations. This intervention, which is supposed to     simulate walking on natural, uneven surfaces, is compared to a conventional treadmill     training.      Hypothesis: Sensorimotor treadmill training leads to larger improvements in walking and     balance abilities as compared to conventional treadmill exercise.   "
109270|NCT01855737|"     1. Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in          Chinese patients        2. Drug: Warfarin        3. Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm          calculated dose and actual dose in the Chinese patients.        4. Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in          Chinese patients.   "
109233|NCT01856218|"     UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of     UX003 in MPS 7 subjects via IV administration every other week (QOW) for 36 weeks with up to     an additional 36 weeks from the optional continuation period. Up to 5 subjects, who are     between 5 and 30 years of age inclusive, will be enrolled and treated with UX003.      The initial 12-week treatment period will be followed by a 24-week forced dose titration     period to assess the optimal dose. Subjects who complete both the initial treatment and     forced dose titration periods will continue treatment in a 36 week continuation period   "
109234|NCT01856205|"     Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of     an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening     conscious level and seizures. Around a third will die from the infection and half of     survivors have serious long-term neurological disability. The majority of those affected are     children. There are many causes of viral encephalitis, however Japanese encephalitis virus is     the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia     and the geographical range is expanding. There is no specific treatment for Japanese     encephalitis virus, although several have been trialed. In this study we examined the effect     of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis     in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese     encephalitis virus and suppress damaging inflammation in the brain. It has previously been     used in individual cases but never examined in a randomized trial. There was recently a trial     of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the     Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is     safe in this context, and that this treatment may alter the way the immune system manages the     infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely     given to children with suspected JE, with no increased risk of serious adverse events     compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability     randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with     Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory     markers called cytokines and blood brain barrier markers, and the effect of IVIG on these     relationships.   "
109236|NCT01856179|"     The objective of this study is to investigate the conversion of the precursors ALA and SDA     into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in     comparison with SDA soybean oil (positive control). In addition, the accumulation of n-3     LC-PUFA is compared between subpopulations of different age, gender and physiological     conditions (overweight, increased serum total cholesterol).   "
109237|NCT01856166|"     Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented     delivery rates.      To assess the best maintainance regimen of epidural analgesia during labor the investigators     plan to include 300 nulliparous in this multicenter randomized, double blind trial. The     primary outcome will be a composite set of criteria that can lead to instrumented delivery.     Secondary outcome will focus on analgesia motor block and satisfaction.   "
109238|NCT01856153|"     Primary objective is to determine if the efficacy of strawberries delivering polyphenols to     prevent metabolic inflammation will be influenced by timing of consumption relative to meal     intake.      Secondary objective is to characterize the relative bioavailability and absorption profile of     strawberry polyphenols consumed with meal or at alternatives times around a meal (2 hours     before the meal ad 2 hours after the meal).      Third objective is to determine the bioavailability/absorption profile of strawberry     polyphenols and its relationship with the anti-inflammatory mechanism of action of strawberry     constituents.   "
109239|NCT01856140|"     Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived     mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be     administrated to the patients with lateral epicondylitis by ultrasonographic guided     injection.   "
109326|NCT01855009|"     This study will compare changes in body composition (lean mass, fat, and bone)and parent     ratings of quality of life in 5-19 Year Olds as a function of participation in one of four     versions of the Good NEWS 4 Kids Program (GN4K).   "
109327|NCT01854996|"     This study aims to test plasma exposure to PF-05089771 with same formulation will be used for     phase II trials (capsule).   "
109240|NCT01856127|"     This is a three-center, randomized, double-blind, fixed dose study designed to assess the     efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction     associated with use of a selective serotonin reuptake inhibitor (SSRI) and     serotonin-norepinephrine reuptake inhibitor (SNRI)compared to switching to sertraline in     patients with Major Depressive Disorder (MDD).      Vilazodone is a newly introduced, FDA approved antidepressant that is a combined serotonin     specific reuptake inhibitor and serotonin 1A receptor partial agonist. In contrast to the     SSRIs and SNRIs, appears to have low adverse effects on sexual functioning when compared to     placebo.   "
109241|NCT01856114|"     The goal of this clinical research study is to learn if fentanyl can change perception of     shortness of breath in cancer patients. Researchers also want to learn if the study drug can     help to improve your physical function. In this study, fentanyl will be compared to a     placebo.      Fentanyl is commonly used for treatment of cancer pain.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
109242|NCT01856101|"     The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays     an important role in cell growth, proliferation, survival and angiogenesis through sensing     and integrating energetic signals from cellular environment. The mTOR protein is composed of     two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2).      In regards of mTOR pathway dysregulations observed in TCC development, there is a rational to     test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition, binds     to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.   "
109243|NCT01856088|"     The main objective of this study is to evaluate the effectiveness of stent Inspiron ™     sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in     native coronary arteries.   "
109271|NCT01855724|"     The purpose of this study is to determine whether gemcitabine and pazopanib are effective in     the treatment of inoperable, locally advanced or metastatic biliary tree cancer     (cholangiocarcinoma or gallbladder carcinoma).   "
118150|NCT01739465|"     The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic     therapy for inoperable cholangiocarcinoma   "
109246|NCT01856049|"     Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many     years. However, congenital heart disease with severe structural abnormalities may also be     reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally     growing and may be the most amendable to regenerative strategies. Therefore, identifying     autologous cells (cells from the patient's own body) would be important to initiate these     studies.      This study aims to validate the use of umbilical cord blood as a source of autologous cells     for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from     the cord blood to help us determine the feasibility of collection, processing, and storage of     these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left     heart syndrome. This study may be useful for the development of pre-clinical and clinical     studies aimed at the long-term goal of repairing damaged heart muscle.   "
109247|NCT01856036|"     This protocol will study the impact of cryoablation on immune response in patients diagnosed     with invasive breast cancers smaller than 1.5 cm. It will profile the immune response to     cryoablation of invasive breast cancers. The intra-tumoral and systemic immune response to     cryoablation will be determined and compared to pre-ablated breast cancer specimens and     historical control specimens.   "
109248|NCT01856023|"     Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic     melanoma who are treatment naïve or have previously received a single non-immunologic     therapy.      Treatment Arm 1: Patients will receive two courses (four cycles) of High Dose Interleukin-2     (HD IL-2) followed by one course (four doses) of ipilimumab.      Treatment Arm 2: Patients will receive one course (four doses) of ipilimumab followed by two     courses (four cycles) of HD IL-2.      HD IL-2 and ipilimumab dosing regimens will comply with the instructions in the most current     package inserts, institutional guidelines, and medical expertise of the treating physician.     However, neither the ipilimumab nor the HD IL-2 should be dose reduced. If necessary, doses     should be either held or permanently discontinued (per package insert instructions). Protocol     specific dosing guidance is included in the 12PLK02 Work Instructions.      Patients will be scheduled for four response assessments. Response assessment timing should     be targeted to fall within the following time points: between 5-11 weeks, 13-19 weeks, 24-30     weeks and one year after initiating therapy in either treatment arm. Timing of the response     assessments may be adjusted to facilitate clinical procedures and treatment decisions.      Patient treatment tolerability and safety events will be monitored and managed while enrolled     in the 12PLK02 study. Patients who receive HD IL-2 in the 12PLK02 study will be enrolled in     the PROCLAIM study (Registry Protocol 10PLK13) for the collection of long-term assessment     data, including response and disease status and treatment decisions. Patient treatment data     will be entered in to the PROCLAIM database, for a minimum target of 2 years and potentially     up to 5 years, after the patient completes the 12PLK02 study.   "
109249|NCT01856010|"     Agitation/aggression is one of the most common and serious behavioral complications of     dementia. If the behavior is refractory to standard care (behavior approaches and off label     use of psychotropic medications), other evidence based treatment options are not currently     available. Retrospective reviews and preliminary studies have indicated Electroconvulsive     Therapy (ECT) may be a safe, effective intervention in this patient population. This study     will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition,     mood and psychosis for patients referred for ECT who accept this intervention vs. those     patients referred for ECT but decline this intervention (i.e. standard care controls). It     will also assess adverse events, activities of daily living and caregiver burden during study     participation. The hypothesis is that subjects with dementia related aggression/agitation who     receive ECT will show significantly greater reductions in these behaviors than subjects who     do not consent for ECT and continue with standard care. Pine Rest is partnering with McLean     Hospital (Massachusetts) to answer this question. To our knowledge, this is the first     prospective study to examine whether patients receiving ECT or standard care differ in     reduction of aggression and agitation symptom severity and changes in cognition pre- and     post- treatment.   "
109250|NCT01855997|"     This Phase 4 study is designed for the collection of blood biomarker samples from     participants who have completed CHB treatment with at least 24 weeks of a pegylated     interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment     follow-up. Participants may be enrolled from historical studies supported or sponsored by     Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The     follow-up of individuals who choose to participate in this study will be in accordance with     the ongoing studies or with the general medical practice of the physician. Data from whole     blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from     previously collected Roche Clinical Repository (RCR) samples will be used for combined     analysis with data from other applicable studies. Procedures will include blood sample     collection (not applicable for participants who previously have consented and donated RCR DNA     samples) and medical record capture.   "
109251|NCT01855984|"     The purpose of this study is to determine if tocotrienol supplementation given to school     going children with ADHD will result in reduction of their ADHD symptoms.   "
109252|NCT01855971|"     Fragile X syndrome (FXS) present alterations in synaptic plasticity that produce intellectual     disability. can produce improvement. Estrogens (targeting Estrogen Receptors beta (ER-β) can     act as neuroprotective agents, promoting synaptic plasticity and neurite outgrowth, and     health benefits derived from flavonoids, as the flavonol epigallocatechin gallate (EGCG),     phytoestrogens of natural origin are partially explained by their interaction with membrane     ER. Selective ER-β flavonoids are thus good candidates for their therapeutic evaluation in     intellectual disabilities. EGCG also targets central intracellular transduction signals     altered in FXS and improves memory recognition in a FXS animal model(adenosine triphosphate     (ATP)-inhibitor of phosphatidylinositol 3-kinase (PI3K)and mammalian target of rapamycin     (mTOR) and extracellular signal-regulated kinase (ERK1/2). This study targets the synaptic     plasticity alterations that underlie the learning and memory impairment but also the     computational disability in FXS. The hypothesis is that EGCG can act by favoring the     physiological processes involved in cognition.   "
109272|NCT01855711|"     This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in     Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and     (ii) to obtain reference data for endpoints and dosage and administration of a next phase     study.   "
109253|NCT01855958|"     The aim of this study is to evaluate the cortical excitability in pain of knee osteoarthritis     (OA), as well as the effect of one session of a kind of electroacupuncture (deep needling     intramuscular stimulation therapy - DIMST) in this pain and the cortical excitability after     the intervention.      The hypothesis is that cortical excitability is altered in this condition, confirming the     findings already described in other chronic pain conditions. The investigators also believe     that a session DIMST can reduce pain and alter cortical excitability, restoring its previous     activity will occur from chronic pain.   "
109254|NCT01855945|"     Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in     children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly     65 years and older.   "
109255|NCT01855932|"     The Enlighten study is an 8-week trial investigating the response to use of a smartphone diet     and activity application. Participants are enrolled as part of a worksite intervention, and     will receive the LoseIt! weight loss smartphone application, which requires participants to     self-monitor dietary intake and physical activity, a component shown to effectively produce     weight loss. The application will be programmed to deliver dietary intake recommendations     during the first three weeks of the intervention. At the 3 week time point, self-monitoring     adherence via the smartphone application will be assessed and those who are not responding     will receive 4 weekly telephone coaching sessions. Those individuals who respond at the end     of 3 weeks will be encouraged to continue self-monitoring on the application. All     participants will also receive regular text messages throughout the trial. The importance of     the proposed research lies in the objective to reconfigure weight loss treatment so as to     achieve the intended outcome more efficiently and in a manner that allows greater reach.   "
109256|NCT01855919|"     The purpose of the study is to assess the efficacy and safety of duloxetine in participants     with Chronic Low Back Pain (CLBP).   "
109257|NCT01855906|"     The purpose of this study is to examine the impact of two surgical techniques on the outcome     of the knee replacement surgery.   "
109258|NCT01855893|"     The purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital     pressure in points of acupuncture) added to the conventional treatment.   "
109259|NCT01855880|"     This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose,     multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque     psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and     pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients     with moderate to severe chronic plaque psoriasis.   "
109260|NCT01855867|"     The purpose of this study is to see if an anti-HIV medication known as Stribild     (elvitegravir/cobicistat/emtricitabine/tenofovir DF) is safe, tolerable and acceptable when     taken for 28 days, once a day after a possible, sexual, exposure to the Human Immune     Deficiency Virus (HIV).   "
109261|NCT01855854|"     This study is designed to evaluate the efficacy and safety of icotinib in treating advanced     carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or     positive FISH, the primary endpoint is objective response rates.   "
109286|NCT01855529|"     After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and     68%. They begin after surgery and may persist until more than 6 months. They respond poorly     to opioid analgesics impair the quality of life.      Among the different postoperative analgesic techniques used, the use of a local anesthetic     infiltration continues catheter has advantages including improving the quality of analgesia,     with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine     consumption, improving the quality of life of patients.      Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in     the control of postoperative pain after mastectomy.   "
109328|NCT01854983|"     Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence     imaging for the screening of cervical cancer   "
109262|NCT01855841|"     ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be     effective in multiple bilio-pancreatic indications. However, one of the feared complication     of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient     groups have been demonstrated to present a higher risk linked to individual factors or to the     procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the     incidence of this complication but each has his own inconvenient. Recently, the activation of     heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be     effective in prevention and treatment of acute pancreatitis mice models. This protective     effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated     by hemin. The investigators thus propose to conduct a prospective randomized double blind     controlled trial to demonstrate a protective effect of hemin administration against post-ERCP     acute pancreatitis in high risk patients.   "
109263|NCT01855828|"     The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the     anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin)     concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The     study will also test the safety of this therapy.   "
109264|NCT01855815|"     The purpose of the Hemolung RAS Registry Program is to collect retrospective, de-identified,     standard of care data following the commercial use of the Hemolung RAS.   "
109265|NCT01855802|"     This attempts to investigate the perceptions of Greek Ophthalmologists regarding generics     prescription in glaucoma by means of a structured questionnaire.   "
109266|NCT01855789|"     This randomized, multicenter, double-blind, parallel group study will evaluate the impact of     MTX discontinuation on the efficacy of subcutaneous tocilizumab (RoActemra/Actemra) in     participants with moderate to severe active rheumatoid arthritis who have an inadequate     response to current MTX therapy. Participants will be initiated on tocilizumab 162 milligrams     (mg) weekly or every 2 weeks, remaining on a stable dose of MTX. At Week 24, participants     achieving DAS28 less than or equal to (</=) 3.2 will be randomized to either continue     receiving a stable dose of MTX or to switch to matching placebo until Week 52. In the     magnetic resonance imaging (MRI) substudy of participants in both treatment arms (MTX or     placebo), MRI images of hands and wrists will be obtained and analyzed.   "
109267|NCT01855776|"     This study aims to assess the uptake, effectiveness, and cost-effectiveness of a scalable     walking programme for full-time employees both with and without incentives.   "
109268|NCT01855763|"     The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy     metformin treatment compared with insulin will result in better perinatal and maternal     outcome and improved treatment acceptability with low or noadditional insulin requirement.   "
109269|NCT01855750|"     The purpose of this study is to evaluate if ibrutinib administered in combination with     rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the     clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of     diffuse large B-cell lymphoma (DLBCL).   "
109274|NCT01855685|"     X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects     boys. It is caused by an error in a gene that makes part of the immune system. The basic     defect lies in specialised white blood cells called phagocytic cells (or phagocytes), which     are responsible for protection against infection by destroying invading bacteria and fungi.     They do this by pouring large amounts of substances similar to bleach onto these organisms.     In CGD, there is a defect in the system that makes the bleach, called the NADPH-oxidase. In     X-CGD (which accounts for two thirds of patients), the defect lies in a gene which makes up a     critical part of the NADPH-oxidase (known as gp91-phox), and the cells cannot make     bleach-like substances. Therefore they kill bacteria and fungi poorly, and the patients     suffer from severe and recurrent infections. This also results in inflammation which can     damage parts of the body such as the lung and gut.      In many cases, patients can be adequately protected from infection by constant intake of     antibiotics. However, in others, severe life-threatening infections break through. In some     cases, inflammation in the bowel or urinary systems results in blockages which cannot be     treated with antibiotics, and which may require the use of other drugs such as steroids.     Development of curative treatments for CGD is therefore of great importance.   "
109275|NCT01855672|"     The objective of this proof-of-concept study is to generate initial safety and effectiveness     data for the neuro-modulation stimulation (NMS) E-Box in patients with chronic migraine in an     acute setting. The results of this study will determine if further development of this device     in a larger study is warranted.   "
109276|NCT01855659|"     Peak Inspiratory Flow Rate (PIFR) is defined by the fastest flow rate noted during the     inspiratory cycle.      Inhaled medication plays an important role in the treatment of chronic obstructive pulmonary     disease (COPD), with dry powder inhalers (DPIs) increasingly replacing metered dose inhalers     (MDIs). DPIs are interesting as they do not require the need for coordinate actuation of the     MDI device with inhalation or the use of a large spacer device 1-3. Several DPIs are     available for the administration of inhaled corticosteroids, as well as bronchodilators, with     each of them corresponding to a different type of inhaler (e.g. Diskus®, Turbuhaler®,     Aeroliser®, etc.). During the inspiratory effort the patient generates a pressure drop with a     consequent airflow across the DPI. This inspiratory flow has to be high enough to     disaggregate and adequately disperse the drug powder into an aerosol cloud of drug particles     and to guarantee an optimal deposition of the medication in the lung. Such peak inspiratory     flows (PIFs) are not only dependent on a patient's inhalation effort but also on the internal     resistance of the device.      It has been shown that optimal deposition of medication with DPIs is not achieved in some     patients with low inspiratory flow rates, such as children or patients with COPD, especially     during acute exacerbations. In such conditions the use of a DPI with low internal resistance     has been suggested, ensuring an optimal deposition despite the lower flow rate. In addition,     many clinicians are nowadays confronted with an important number of COPD patients who are     aged >70 yrs   "
109364|NCT01854619|"     The purpose of this study is to determine whether the use of light and a topically applied     photosensitizer can relieve symptoms and clinically improve patients with chronic     rhinosinusitis.   "
122497|NCT01682564|"     To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on     blood pressure in patients with hypertension diagnosed congestive heart failure   "
109277|NCT01855646|"     The overall aim of this project is to improve the quality of the handoffs between     hospitalists on the general medicine service at Durham Regional Hospital with the intent of     improving transitions of care. The intervention will be an improved and more structured face     to face sign-out process using a standardized admission sign-out sheet, which is not part of     the official medical record. Daytime admitting physicians will assign an acuity score to     their patients in which the severity of illness will be scored from 1-7, with 7 being the     most sick / likely to have rapid response team (RRT) or adverse event. The assignment of this     score would be based off of the clinician's judgment in the patient's overall assessment. All     patients, age >18 years, admitted to the non-resident hospital medicine general medicine     service at DRH will be study eligible. Data analysis will examine aggregate hospitalist     perception of sign-out practice before and after intervention, total number of RRTs,     unplanned transfers, and rapid responses pre and post intervention, percentage of hospitalist     based patients of overall rapid responses pre and post intervention, percentage of     hospitalists using acuity scores, and average and mean severity score of patients with rapid     responses compared with those admitted. Patients have a risk of loss of confidentiality.   "
109278|NCT01855633|"     Stroke is one of the major causes of death in the World. Many stroke survivors may suffer     from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy     are limited. The development of new treatment strategies is essential. Repetitive     transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal area     of the brain for restoring brain function. The aim of this study is to investigate the     therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.   "
109279|NCT01855620|"     Two-thirds of young women in the United States are overweight or obese. This excess weight     may affect how their body metabolizes drugs such as different birth control methods. There is     a not a lot of research about how excess weight could affect the hormone levels of the     contraceptive implant. Methods like the implant contain only progesterone, which is a hormone     that does not increase a woman's risk of blood clot. These methods would be preferred for     overweight and obese women because excess weight also increases a woman's risk of blood clot.      The investigators propose a study comparing blood hormone levels of women using the implant     for at least twelve months and in all weight categories. The investigators hope to show that     all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.   "
109280|NCT01855607|"     To assess whether six week treatment with twice a day topical Menthol application will     decrease persistent neuropathic pain from chemotherapy among breast and colorectal cancer     patients.   "
109281|NCT01855594|"     To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of     patients with spinal cord injury.   "
145013|NCT01386268|"     To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life     conditions in its registered indications.      The observation period for each patient is up to 6 months.   "
109282|NCT01855581|"     Sedation and anesthesia for diagnostic imaging represents a rapidly growing field of     practice, especially in children. Propofol is the most common sedative drug administered for     MRI/CT. However, this drug is associated with adverse events, including pulmonary     complications, and there has been no report on these complications in Korea.      The investigators reviewed 3739 charts of pediatric patients sedated for MRI/CT between     January and November 2012.      In this study, the investigators will report the nature and frequency of adverse events     associated with sedation for MRI/CT between January and November 2012.   "
109283|NCT01855568|"     Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality.     Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in     the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic     pregnancy. The main stays of management for ectopic pregnancy were surgery and medical     treatment. Medical management with systemic methotrexate administration avoids the inherent     morbidity of anesthesia and surgery is cost-effective, and also offers success rates     comparable to surgical management, with no loss in future potential fertility.      However, although medical management using methotrexate is used commonly, there is no solid     consensus regarding dose protocol. Currently, there are three methotrexate protocols for the     treatment of an ectopic pregnancy, multi-dose, single-dose, or two-dose. Among them,     the multi-dose protocol includes the administration of 4 methotrexate doses alternating with     leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side effects     are more common. In contrast, the advantages of the single-dose protocol include elimination     of a rescue regimen, lower incidence of adverse effects, and better compliance. However, the     single-dose protocol was found to be associated with a considerably lower success rate as     compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. The     two-dose protocol, which it balances efficacy and safety/convenience, was described as a     cross between the multi-dose and single-dose protocols.      However, there were a few studies comparing between single-dose and two-dose protocol. The     purpose of this prospective randomized trial was to compared the success rates of single-dose     and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.   "
109284|NCT01855555|"     Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing     field of practice, especially in children. Propofol is the most common sedative drug     administered for MRI/CT. However, this drug is associated with adverse events, including     pulmonary complications, and there has been no report on these complications in Korea. In     this prospective observation study, the investigators will report the nature and frequency of     adverse events associated with propofol-based sedation for MRI/CT.   "
109285|NCT01855542|"     Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance     and metabolic acidosis in critically ill patients. The aim of this investigation is to     compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and     electrolytes in healthy patients undergoing major spine surgeries.   "
109287|NCT01855516|"     This study is designed to assess: the incidence of abnormal partial thromboplastin time in     patients receiving unfractionated heparin (UFH) 5000 U 2 times a day versus 3 times a day 72     hours after administration of the first dose of heparin.      Hypothesis: The basic hypothesis of this study is that patients receiving UFH 5000 U     subcutaneously 3 times a day will have a higher proportion of elevated partial thromboplastin     time than patients receiving UFH 5000 U subcutaneously twice a day.   "
109288|NCT01855503|"     This is a molecular testing study for patients with metastatic breast cancer. The purpose of     this study is to find defects in the DNA of the cancer that could potentially be treated with     US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your     cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a     change int he DNA sequence of a gene) that makes this receptor superactive a drug that     inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is     not present in the cancer the same drug may not work. This EGFR gene mutation based patient     selection for treatment has worked in lung cancer and we are testing its value in breast     cancer. What drugs may be available against particular genetic abnormalities in the context     of this clinical study will change over time.   "
109289|NCT01855490|"     The study is designed as an open labeled pilot trial to analyze the acute responses of     glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or     intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide     (Byetta) 5 mcg sc.      The investigators will also test the effects of Exenatide on gastric emptying during the     MMTT.   "
109313|NCT01855178|"     Nocturnal seizure and Sudden unexplained death in epilepsy patients (SUDEP) are major     concerns for parents and creates anxiety and poor sleep conditions for many families dealing     with epilepsy. An accurate and reliable system for alerting parents to ongoing seizure     activity could make a substantial impact in quality of life and possibly reduce the mortality     of epilepsy. No previous studies in the pediatric population have been performed to evaluate     this type of monitoring for seizure activity. This is one of the most common questions     parents ask in clinic, Are there any alarms that can tell me when my child is having a     seizure at night? Currently the answer is no. This study has the capability to give us data     that may change this answer to yes.   "
109314|NCT01855165|"     Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and     their incidence increases with the number of drugs that the patients are prescribed for     treatment of their condition. Data bases often detect DDIs that are of high clinical     relevance. The investigators have performed this study in order to detect clinically     significant DDIs and to diminish their occurrence by sending notification about DDIs to     attending physician.   "
109290|NCT01855477|"     A major challenge for researchers in cancer care is to expedite the development of new     therapeutics and the Center for Personalized Cancer Treatment (a collaboration of the Dept.     of Medical Oncology from the University Medical Center Utrecht, Netherlands Cancer Center -     Antoni van Leeuwenhoek hospital and the Erasmus Medical Center - Daniël den Hoed clinic) is     an initiative to achieve this goal.      The current and future generation anti-cancer drugs are developed to specifically activate or     deactivate deregulated gene products or signaling pathways in cancer cells. The development     of such targeted agents is an exciting new opportunity that promises to deliver more     anti-cancer efficacy and less toxicity. Although targeted therapy has been a breakthrough in     medical oncology leading to the development of a portfolio of potentially successful new     drugs, it has not yet delivered the much needed relief for large patient populations. We     believe that the development of these agents is mainly hampered by our lack of successful     patient selection.      The CPCT aims to select patients for clinical trial participation based on the results of     Next Generation Sequencing (NGS) information obtained from tumor material. The advent of NGS     platforms enables us to probe a significant proportion of the cancer genome and thus to     develop a realistic view on the complex genetic changes in cancer cells. The CPCT aims to use     NGS platforms to improve the selection of patients for targeted therapy trials.      We will obtain tumor biopsies of a (preferably) metastatic or locally advanced lesion and     peripheral blood sample from all patients included in the trial; the biopsies to obtain     information on the tumor related genetic mutations (mutational profile) and the blood samples     to assess each patient's germline DNA background variation. As patients will be asked to     undergo an invasive procedure it is important to address the potential safety issues. Review     of the literature shows that in general tumor biopsies can be performed with only minor     complications and acceptable risks. We will recruit patients with metastatic or locally     advanced (incurable) solid tumors and we aim to use the information obtained from DNA     sequencing to stratify patients for inclusion in clinical trials. The final personalized     treatment decision will be made dependent on the availability of trials and the expected     predictive value of the mutational profile.   "
109291|NCT01855464|"     Primary spontaneous pneumothoraces (PSP) represent a significant public health problem,     occurring in young healthy subjects without pre-existing lung disease or precedent medical     intervention or trauma with a reported incidence of up to 18-28/100 000 per year. PSP     treatment often requires thoracic surgery to restore lung expansion and to prevent de novo     lung collapse. Despite the presence of elaborated guidelines by the British Thoracic Society     (BTS) postulating apical wedge resection of the lung and total parietal pleurectomy (WRPP),     the majority of German hospitals gathered experience especially in limiting surgery to     cost-saving partial apical parietal pleurectomy or yet apical pleural abrasion (PP). Until     today, hardly any reliable data exist to analyze and compare the varying treatment approaches     regarding efficacy and efficiency. In this randomized, multi-centric clinical trial, both     treatment approaches will be compared. For this purpose, candidates for surgery will be     randomized into one of the two treatment groups after informed consent has been obtained.     Patients will be followed for 2 years by the participating centres to be able to evaluate the     long-term effect of the surgical interventions.   "
109292|NCT01855451|"     A standard treatment for patients with head and neck cancer is radiation given with high     doses of a chemotherapy drug called cisplatin, given every 3 weeks during the radiation. This     treatment is effective but can significantly increase side effects such as difficulty with     swallowing, a sore mouth, fatigue, hearing loss, ringing in the ears and kidney failure. In     Australia, a commonly used treatment HPV-Associated Oropharyngeal Squamous Cell Carcinoma is     a lower dose of cisplatin given weekly during the radiation. The high dose and low dose     schedules result in a similar total dose of cisplatin being given during the radiation, but     it is thought that the weekly schedule results in fewer side effects while maintaining     effectiveness.      Another approach widely used around the world for patients with head and neck cancer, is to     administer the antibody, cetuximab, weekly during radiation. Cetuximab has a very different     side effect profile to cisplatin, and has been reported to result in less exacerbation of     radiation related side effects. Both cetuximab and cisplatin can reduce the growth of a     cancer and increase the effectiveness of radiation. Both cisplatin and cetuximab appear to be     effective treatments in combination with radiation, but have not been directly compared.      The purpose of this study is to compare the treatment related side effects (both acute and     longer term) between the cisplatin and cetuximab regimens. Both treatments would be given     with the same dose of radiation therapy over 7 weeks. The results of this trial will help     determine the optimal treatment for patients with HPV-Associated Oropharyngeal Squamous Cell     Carcinoma.   "
109293|NCT01855438|"     This study will test the efficacy of a communication intervention intended to increase and     improve kidney transplant candidates' communication about live donor kidney transplantation.   "
109296|NCT01855399|"     Peer support programs have been demonstrated to improve glycemic control among Veterans with     poor control. This program will expand on this success by putting innovative tools in the     hands of Veteran diabetes patients. Veteran coaches who have demonstrated effective control     of their own diabetes will be trained to use communication skills to guide their peers     through a diabetes education and decision aid. This tool, which is an iPad application, draws     the patient in by showing them their personal risk and medication information derived from     baseline labs and self-reported survey data. The tool encourages interaction by providing     choices of materials to view, using audio-visual elements and incorporating a goal-setting     process for developing self-management action steps and questions to discuss with their     doctor at their next clinic visit. Ongoing weekly contact between the Veterans is supported     by a confidential phone system.   "
109297|NCT01855386|"     The thought is that Non-Alcoholic Fatty Liver Disease (NAFLD) plays a key role in the     progression to prediabetes/T2DM in those with a history of Gestational Diabetes (GDM). The     investigators want to know if having a fatty liver will be connected with more glucose     abnormalities (higher fasting/oral glucose tolerance test glucose, more insulin resistance)     and that a history of GDM will be common in those with NAFLD.   "
109298|NCT01855373|"     To purpose of this study is to assess the effectiveness, safety and tolerability of PEAK ATP®     with GlycoCarn®, PEAK ATP® and GlycoCarn® on levels of blood sugar and endothelial function     improvement which may lead to improved vascular health.   "
109299|NCT01855360|"     The objective of the study is to determine whether the combination of the bile acid TUDCA,     and doxycycline will slow the progression of familial and senile amyloidosis.   "
109331|NCT01854944|"     The purpose of this study is to determine how low and high does of brexpiprazole binds to     certain receptors in the brain. This will be determined by PET scans taken pre-dose and     post-dose.   "
109300|NCT01855347|"     There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature     infant population, principally those with associated risk like extreme prematurity, extreme     low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia)     and those born in hospitals with limited resources for optimal neonatal care.      Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in     cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen     delivery.(3) In the premature patient population, many neurologic injuries occur as a result     of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been     focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin     tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to     validate NIRS measurements and have established normative data.(4-6) The non-invasive method     of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care     units in patients at risk for neurological injuries. This method has been successfully     validated to monitor neonatal cerebral oxygenation in different clinical settings and study     protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and     oxygen dynamics.      One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis.     It is important to monitor not just cerebral perfusion but also the intestinal     oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change     their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS     in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12);     these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature     infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations     in intestinal oxygenation and perfusion.      In summary, a-NIRS could be use in the premature infant population to define reference     values, especially in patients at risk, which would then facilitate the early diagnosis of     NEC spectrum diseases.   "
109301|NCT01855334|"     Cardiovascular disease is the primary cause of death in patients with end stage renal disease     (ESRD). New research suggests that the high risk of death may be partly due to high levels of     fibrosis and a loss of small blood vessels in the heart of patients with dialysis-dependent     ESRD. This study is designed to compare the effects of two different drugs, spironolactone     and L-arginine, with placebo on structure and function of the heart in individuals with     dialysis-dependent ESRD.   "
109302|NCT01855321|"     This pilot study will investigate the effect of Vitamin D supplementation in improving     glucose control with patients with poorly controlled diabetes and concurrent Vitamin D     deficiency.   "
109303|NCT01855308|"     This is a study of new technology to allow gallbladder removal through a single small     surgical incision. A surgical robot is utilized to help navigate the small space. In this     study, patient characteristics are broad to assess how applicable the procedure is to     everyone.   "
109304|NCT01855295|"     Poor nutritional status as evidenced by low body mass index, low muscle mass or low serum     albumin is a strong predictor of morbidity and mortality in dialysis patients.     Hypercatabolism induced by inflammation is widely considered the cause of uremic malnutrition     even though there is no clear evidence that hemodialysis patients with elevated C-reactive     protein (CRP) levels are at greater risk of losing weight or muscle mass. Conversely, there     is little data on whether dialysis patients with malnutrition and elevated C-reactive protein     levels would gain muscle mass with protein supplementation.      The hypothesis is that protein supplementation during dialysis will improve muscle mass,     functional status and quality of life in inflamed malnourished hemodialysis patients.     Therefore, the objectives of the current proposal are to examine in malnourished (body mass     index < 23 kg/m2 or serum creatinine < 8 mg/dL) hemodialysis patients with inflammation (high     sensitivity CRP > 3 mg/dL), the effects of protein supplementation on        1. Muscle mass as determined by creatinine kinetics        2. Functional status as assessed by 6 min walk        3. Quality of life as assessed by Short Form -12 survey   "
109305|NCT01855282|"     This is a study to assess the effectiveness of a culturally appropriate behavioral     intervention to reduce obesity levels and ultimately the risk of developing diabetes type II     in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into     an intervention or control arm of the study. The intervention participants received weekly     classes for 10 weeks with education on diabetes, diet and physical activity and practical     exercises. Both control and intervention were measured for weight, waist circumference,     fasting blood glucose and interviewed before and after the study intervention. The main     hypothesis was that intervention, but not control participants, would experience reduction in     body measurements after the intervention.   "
109306|NCT01855269|"     The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a     prospective randomized controlled study would improve symptoms of infantile colic.   "
109307|NCT01855256|"     Evaluation of the effectiveness of oxybutynin in hyperhidrosis   "
109502|NCT01852708|"     The purpose of this study is to collect maternal blood samples from pregnant women carrying a     fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including     microdeletions in order to further develop a non-invasive prenatal screening test based on     fetal DNA isolated from maternal blood.   "
109308|NCT01855243|"     Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus     modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens     for glycemic control in hospitalized diabetic patients with diabetes.      Methods: In a prospective trial, patients with diabetes will be randomized to receive either     traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin     for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥     150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day     for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.   "
109309|NCT01855230|"     The purpose of this study is to evaluate the safety, tolerability, and clinical activity of     ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or     GOLD 3 COPD.   "
109310|NCT01855217|"     Should the dose of sugammadex in morbid obese patients be calculated on the real body weight     or the ideal body weight?      To study the pharmacodynamics of sugammadex in morbidly obese patients by comparing 1 mg/kg     IBW versus 1 mg/kg TBW versus placebo.   "
109311|NCT01855204|"     Computed Tomographic (CT) urography is the best imaging modality to evaluate obstructing     lesions of urinary tract such as urinary stone, tumor and inflammatory lesion. The purpose of     our study is to compare images of CT urography performed by low voltage and low concentrated     iodine CT contrast with them of conventional CT urography.   "
109312|NCT01855191|"     Introducing standardized data collection (SDC) for lung cancer patients to improve the     performance of the prediction models.   "
109332|NCT01854931|"     The overarching objective of this project is to assess the potential public health impact of     delivering Tai Ji Quan: Moving for Better Balance, a proven fall prevention program, through     local community dissemination partners (e.g., senior service providers), in the selected     counties in the state of Oregon.   "
109333|NCT01854918|"     This study will contribute to the evaluation of long-term safety, tolerability and efficacy     of evolocumab (AMG 145) in subjects with hyperlipidemia and subjects with mixed dyslipidemia.   "
109315|NCT01855152|"     800,000 people in the United Kingdom (UK)have dementia, of which 250,000 are living in care     homes. These individuals have complex mental health problems, disabilities and social needs,     which if unmet will continue to adversely affect each individual, as well as the main goal of     enabling people to live well with dementia, as presented in the National Dementia Strategy     (NDS) (Department of Health, 2009).      This optimized intervention WHELD is based on a factorial study and qualitative evaluation     designed to facilitate the design of this current study and will combine this with the most     effective elements of existing approaches to develop a comprehensive but practical     intervention to improve quality of life in persons with dementia living in care homes. The     intervention will combine training on person centred care, promoting person centred     activities and interactions and provide care home staff and general practitioners with     updated knowledge regarding the optimal use of psychotropic medications for persons with     dementia in care homes.      The overarching goal of this trial is to determine whether this optimised WHELD intervention     is more effective in improving the quality of life and mental health, than the usual care     provided people with dementia living in nursing homes. The cost effectiveness of the     intervention will be assessed as well, with the aim to provide a cost effective, simple and     practical intervention, improving quality of life and mental health of people with dementia     in care homes; which can be rolled out nationally to all UK care homes as an National Health     Service (NHS) intervention. The trial will be a randomised controlled 2-arm cluster single     blind trial that will take place for 9 months across 80 care homes in UK.   "
109316|NCT01855139|"     The objective of this NIS is to assess in a real-life setting, usage patterns and associated     outcomes in the management (healthcare resource utilisation and associated costs) of patients     with non-valvular AF treated with Xarelto, in accordance with the terms of the European     marketing authorization and the Belgian reimbursement criteria.   "
109317|NCT01855126|"     In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research,     University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a     low-cost, minimally obtrusive device that delivers individualized light therapy to adults     with early-awakening insomnia - the most common sleep disturbance in older adults, and a     significant problem because of its relationship to daytime sleepiness, use of potentially     hazardous sleep medication, and reduced quality of life. The proposed device will measure     light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and     deliver an individualized light dosage while subjects are asleep. Light applied through     closed eyelids in the early part of the night will delay the dim light melatonin onset, a     marker of the circadian clock, and help those with early sleep onset to fall asleep later   "
109318|NCT01855113|"     This study aims to compare the pain experienced by patients undergoing orthodontic treatment     with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment     with conventional braces. Because the aligners are removable, nearly invisible and don't     involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign     Treatment and less affectation of the quality of life.   "
109319|NCT01855100|"     The objective of this NIS is to assess in a real-life setting, usage patterns and associated     outcomes in the management (healthcare resource utilisation and associated costs) of patients     with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the     European marketing authorization and the Belgian reimbursement criteria.   "
109320|NCT01855087|"     There is paucity of information about the combination therapy with dipeptidyl peptidase-4     inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety     and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.   "
109321|NCT01855074|"     The purpose of this study is to evaluate the efficacy and safety of long acting injectable     microspheres of risperidone in participants with schizophrenia (psychiatric disorder with     symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders     (disorders in which there is a loss of ego boundaries or a gross impairment in reality     testing with delusions or prominent hallucinations).   "
122498|NCT01682551|"     This trial is aimed to evaluate the effects of Wu Zhu Yu Tang on the prevention of Acute     Mountain Sickness(AMS).   "
109329|NCT01854970|"     Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the     larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very     changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these     reflux and to identify patients with abnormal LPR.      To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients     with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.   "
109330|NCT01854957|"     A double-blind, randomized, cross-over phase I/II study to evaluate the safety and the     efficacy of the intravenous administration of autologous Mesenchymal Stem Cells (MSC) to     patients with active multiple sclerosis (MS) resistant to currently available therapies.   "
109335|NCT01854892|"     Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts     for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will     experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will     develop chronic pain and related disability.      While there is growing evidence for the clinical effectiveness of alternative and     complementary therapies to treat low back pain, little is known on the physiologic     consequences and effects of these treatments. Further, additional data is needed to     understand how these different treatment techniques effect clinical changes in pain and     disability. The lack of empirical data hinders acceptance by the wider scientific and     health-care communities, and it also limits the development of rational strategies for using     alternative and complementary therapies.   "
109336|NCT01853839|"     This is an out-patient based prospective, multi-centre, observational post-marketing     surveillance study amongst internists and cardiologists. In this study, patients with     essential hypertension and at least one additional risk factor will be included. Patients may     take any antihypertensive treatment which is approved for cardiovascular protection including     Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four visits from     baseline to endpoint with an additional visit before and after the month of Ramadan.   "
109337|NCT01853826|"     To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally     advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have     never been treated with an EGFR-TKI   "
109338|NCT01853813|"     Bevacizumab in combination with chemotherapy represents a standard of care for first-line     treatment in patients with advanced colorectal cancer. Molecular predictive factors for     bevacizumab efficacy have not yet been identified therefore selection of patients more likely     to benefit from such a treatment approach is not possible. Retrospective analyses suggested     that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary     aim of our clinical trial will be to prospectively ascertain whether bevacizumab in     combination with chemotherapy has an improved clinical activity in patients with high LDH     serum levels compared to patients with normal LDH serum levels   "
109339|NCT01853800|"     Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.     Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood     vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is     therefore being developed for the treatment of thromboembolic events in children and     adolescents. As small children are often unable to swallow tablets, an oral suspension     (mixture of a liquid containing finely distributed solids) has been developed which allows     dosing according to body weight. The objective of this trial is to compare the     bioavailability (proportion of a substance that remains available unchanged in the blood     circulation) of a rivaroxaban oral solution with that of the rivaroxaban tablet approved for     treatment. In order to evaluate the potential influence of food, the oral suspension     containing 20 mg rivaroxaban will be taken after consuming food. In addition, the     pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood),     safety and tolerability will be assessed.   "
109340|NCT01853787|"     -  Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease          (COPD) is also caused by inflammation of peripheral airways walls.        -  Neutrophils and other inflammatory mediators like Interleukin-6 (IL6), Interleukin-8          (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis          Factor alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric          Oxyde (NO) are implicated in the inflammation.        -  NO is produced in response to physical and chemical stress on bronchial epithelium and          plays a critical role in small airways remodelling        -  Exhaled NO concentration is usually used to monitor bronchial inflammation        -  The relationship between stretch and strain of small airways and bronchial inflammation          is not well understood.        -  The investigators hypothesis is that cyclic opening and closure of peripheral obstructed          airways through the consequent stretching and strain acting on them can provoke an          inflammatory response which can be monitored by exhaled NO.        -  The pharmacological effects of bronchodilators may play a role on bronchial inflammation          by reducing the stretching stress on bronchiolar walls thus reducing the production of          NO in exhalate        -  Data about these physiopathological aspects is missing in literature.   "
109341|NCT01853774|"     The purpose of this study is to test the effectiveness of a two-phase intervention using     community-to-clinic navigators to guide individuals from an especially hard-to-reach,     multicultural, and underinsured population into primary care clinics and, subsequently, to     track effects of the intervention on completion of colorectal cancer (CRC) screening in     clinics. A cost-effectiveness analysis will lay the foundation for further implementation and     dissemination research.      Aim 1: Test effectiveness of community group education + tailored navigation versus community     group education only in increasing clinic attendance among low-income, multicultural Arizona     residents, aged 50 to 75 yrs.      Hypothesis 1: Individuals receiving group education classes + tailored navigation will show     higher rates of clinic attendance than those receiving only group education.      * As a separate critical step for those who make clinic appointments, the investigators will     examine the effect on follow through to screening, using initial group assignment as a     control variable in analysis. Patients making clinic appointments will receive referral for     screening and tailored navigation as usual care.      Aim 2: Track outcomes of the Phase I intervention on CRC screening test completion among     low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.      Hypothesis 2: Individuals receiving group classes and tailored navigation during Phase I will     have higher rates of CRC screening test completion than those receiving classes only,     (however this outcome will be primarily due to clinic attendance).      Aim 3: Determine the cost-effectiveness of each phase of the interventions on increasing CRC     screening completion among low-income, multicultural Arizona residents aged 50 to 75 years.      Exploratory Aim 4: Examine the levels of program dissemination from community to clinic to     final screenings using the RE-AIM model.      Research Question 2: What is the degree of Reach, Efficacy, Adoption, Implementation, and     Maintenance of the community-to-clinic navigation, and clinic-to-screening outcomes?   "
109342|NCT01853761|"     The purpose of this study was to analyze microcurrent short and long term effects used with     aerobic exercise on abdominal fat.   "
122523|NCT01682226|"     The purpose of this study is to find out whether the addition of blood stem cells from a     close family member, when added to umbilical cord blood will make the transplant safer.   "
109369|NCT01854554|"     The goal of this clinical research study is to compare IMRT with IMPT in patients with     glioblastoma. Researchers want to learn about cognitive side effects (mental status changes)     that may occur, such as memory loss and impaired thinking.      IMRT is the delivery of focused radiation therapy using photon beams and advanced computer     planning to help shape the dose in order to give the highest possible dose to the tumor with     the least dose to surrounding normal tissues.      IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to     deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in     order to shape the dose to the target with the least dose to surrounding normal tissues.   "
112692|NCT01810887|"     The purpose of this study is to evaluate the pharmacokinetics (explores what the body does to     the drug) and safety of darunavir, and will be administered in combination with Ritonavir in     healthy adult Japanese male participants.   "
109343|NCT01853748|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug to learn whether the drug works in treating a     specific cancer. Investigational means that the drug is still being studied and that     research doctors are trying to find out more about it-such as the safest dose to use, the     side effects it may cause, and if the drug is effective for treating different types of     cancer. It also means that the FDA has not approved this drug for use patients undergoing     adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may     stop cancer cells from growing. This drug has been used in other research studies and     information from those other research studies suggests that this drug may help to prevent the     recurrence of breast cancer in this research study.      The use of T-DM1 in this research study is experimental, which means it is not approved by     any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However,     it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to     die in laboratory studies. In preclinical studies, this drug has prevented or slowed the     growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in     this study are considered part of standard-of-care regimens in early breast cancer. A     standard treatment means that this is a treatment that would be accepted by the majority of     the medical community as a suitable treatment for your type of breast cancer.      In this research study, the investigators are looking to see if the study drug T-DM1 will     have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab     and paclitaxel. The investigators are also hoping to learn about the long term benefits and     disease-free survival of participants who take the study drug T-DM1 in comparison to those     participants to take the combination of trastuzumab and paclitaxel.   "
109344|NCT01853735|"     The purpose of this study is to determine if Enteral Feeding (EN) in patients with a     traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN     will be compared to those who remain nil-per-os (NPO). Additionally, an internal study     control will be performed by analyzing concurrent injured patients requiring an open abdomen     who did not have a bowel injury.      Specific aims:      Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves     fascial closure rate compared to patients who remain NPO.      Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces     infectious complications compared to patients who remain NPO.      Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a     lower mortality rate compared to patients who remain NPO.   "
109345|NCT01854866|"     Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer.     Currently, the management of malignant ascites and pleural effusion is a considerable     clinical challenge. The investigator hypothesized that tumor cell-derived microparticles     packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and     pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for     Phase II clinical trials.   "
109346|NCT01854853|"     Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk     behaviors than those in the general population. In Brazil, among youth seeking HIV testing,     those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk     reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in     Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for     adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents     is not available in Brazil; this application targets this need.      Using quantitative and qualitative methods we will explore the contextual influences on     sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention     adaptation. The investigators will then pilot-test the family-based (parent-adolescent dyad)     intervention HIV, STI and pregnancy prevention intervention with a sample of male and female     youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites     in preparation for the RCT.   "
109347|NCT01854840|"     Primary purpose: to study the relationship between betamethasone placental transfer and the     occurrence and severity of the Hyaline Membrane Disease.   "
109348|NCT01854827|"     The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical     trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG     treatment administered to infants after hepatic portoenterostomy (HPE) for biliary atresia,     as well as investigate preliminary evidence of activity and explore mechanisms of action.   "
109349|NCT01854814|"     The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on     time to doubling of serum creatinine or the onset of end stage renal disease in patients with     advanced IgA nephropathy who are treated with the maximal tolerated daily dose of     losartan.The study will also assess the effects of MMF compared with losartan alone on the     changes of urine albumin excretion and the changes in estimated glomerular filtration rate.   "
109350|NCT01854801|"     The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual     medical care of electro-sensitive patients: by measurement of health status, sensitivity to     electromagnetic fields exposures, and quality of life.   "
109351|NCT01854788|"     Study design: a randomized, crossover trial. Each patient performed three different airway     clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral     posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy     degree in a randomized order. Each technique were applied in 3 sessions during one week at     alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in     each bronchial session was 40 minutes. Seven days were the wash-out time period between the     different techniques.   "
109365|NCT01854606|"     Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC     subtype Diffuse Large B-Cell Lymphoma.      The trial did not progress into Phase II due to the suboptimal tolerability of the     combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There     were no serious safety concerns associated with this combination.   "
112601|NCT01812070|"     This innovative study will compare a newly developed smartphone application for Acceptance     and Commitment Therapy (ACT) to a smartphone application for traditional cognitive behavioral     therapy (CBT).   "
109352|NCT01854775|"     There will be 2 cohorts in this study, each consisting of Part A and Part B.      The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for     elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen     (STR) (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24     (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.      The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically     suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered     E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through     Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥     25 kg.   "
109370|NCT01854541|"     The Visual Management for Radiotherapy Practice (VMRTP) aims to analyze, predict, visualize     and shorten the waiting times for radiotherapy patients. The hypothesis is that this can be     done by the introduction of models that can predict a patient being at risk for waiting too     long as well as visual management tools that visualize the radiotherapy process.   "
109691|NCT01850420|"     This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate     the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia     symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this     suspected virus and thus alleviate fibromyalgia symptoms.   "
109353|NCT01854762|"     The current available antiretroviral (ARV) agents make possible a successful treatment of     virtually all HIV-infected patients, even those heavily experienced subjects, with a history     of previous failure to ARV drugs of different classes. However, some problems are still     present, especially for specific populations, like pregnant women and infants. For these     groups, most of currently available drugs are not used, because the lack of information on     safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child     transmission (MTCT) is still a problem in certain areas of the world, especially in     resource-limited settings. In some settings, women often present to their first antenatal     care visit late in the pregnancy, posing an additional problem: how to effectively treat     these patients to assure they will have an undetectable viral load at the moment of     delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take 6     or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA /     ml of plasma. To achieve this goal, it would be necessary the use of a potent, very     efficacious ARV regimen that could provide such viral decay in a very short period.     Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The     available evidence suggest it has no genotoxic potential, and promotes a rapid decline in     HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting     different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to     be used for prevention of MTCT for women with detectable viral load, presenting late in the     course of pregnancy. Another attractive point is to consider that, due to the similarity     between the integrase enzyme of HIV-1 and Human T-cell lymphotropic virus type-1 (HTLV-1);     RAL could be active against HTLV-1, blocking its replication. If our hypothesis is correct,     the use f RAL-containing ARV regimens would reduce the MTCT of both agents. This study has     the objective of evaluating the efficacy of RAL containing ARV regimens in reducing the HIV-1     RNA plasma viral load below 50 copies/ml, at the end of pregnancy, for late-presenters     pregnant women and to compare the frequency of adverse events for women using RAL-based ARV     regimens and comparators, and for their babies.   "
109354|NCT01854749|"     Assess the efficacy and safety of S1 combined with cisplatin in treatment of     recurrence/metastasis of ESCC   "
109355|NCT01854736|"     This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled,     national, single-centre trial.      The trial will be initiated before 2013 grass pollen season and subjects will be randomised     in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo     group will be treated 2 years with placebo and a third year with active therapy (Grazax®) and     active group will continue the active treatment in the third year. In the last year, all     placebo patients will be changed to active group and active and placebo patients will be     informed about, but the trial will not be unblinded until the end of the third year and     patients won´t know what treatment they were assigned to during the first 2 years.   "
109356|NCT01854723|"     This study will compare the safety, effectiveness, and cost of two different types of     long-acting insulin.   "
109357|NCT01854710|"     It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation     does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc     prolongation following repeat dosing is unknown. Therefore the current study will assess the     potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours     apart, in relation to placebo and an active control in healthy volunteers.      The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec   "
109358|NCT01854697|"     This is a study to evaluate the efficacy and safety of three experimental drugs compared with     telaprevir (a licensed product) in people with hepatitis C virus infection who have not had     treatment before.   "
109359|NCT01854684|"     This phase I trial studies the side effects and best dose of photodynamic therapy during     surgery in treating patients with non-small cell lung cancer that can be removed by surgery.     Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed     to a certain kind of light. When the drug is active, cancer cells are killed. This may be a     better way to treat patients with non-small cell lung cancer.   "
109360|NCT01854671|"     The purpose of this study is to measure the difference in proportion of postpartum women     using contraception after a Community Health Worker (CHW) family planning educational     intervention compared to women who receive standard care in the West Bank district of     Ramallah and Al-Bireh.      Primary hypothesis: Postpartum contraceptive use will increase in women who receive a     dedicated family planning counseling intervention delivered by CHWs during antenatal care     compared to women receiving usual care.   "
109361|NCT01854658|"     This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks),     placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and     Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001),     and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.   "
109362|NCT01854645|"     The overall objective of this study is to assess the efficacy and safety of treatment with     PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation     powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to     very severe COPD.   "
109363|NCT01854632|"     This study will provide the Senegal Ministry of Health with data on the clinical efficacy of     the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy     considerations for influenza vaccine.   "
122524|NCT01682213|"     In this study, the investigator's want to find out if dabrafenib can stop stage IIIC melanoma     from coming back after surgery.   "
109366|NCT01854593|"     We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular     tissue and whole body, intravitreal injection of a low concentration of bevacizumab and     conducting vitrectomy shortly after the injection is useful. In the present prospective,     double-masked, randomized, controlled study, we aimed to verify the usefulness of     intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy     for PDR.   "
109367|NCT01854580|"     The purpose of the study is to investigate the effectiveness and cost-effectiveness of the     integrated care program of a statutory health insurance offering additional homeopathic     treatment to their members   "
109368|NCT01854567|"     The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in     patients with hematologic malignancies undergoing transplantation with myeloablative     conditioning.   "
109371|NCT01854528|"     The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting     antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as     ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with     telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic     hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously     treated with pegylated interferon/ribavirin (pegIFN/RBV).   "
109372|NCT01854515|"     The present study was aimed at investigating the efficacy of nebulizing Budesonide sin     comparison with intravenous Dexamethasone before extubation in prevention of post-extubation     complications amongst patients admitted in intensive care unit.      In this double-blind randomized clinical trial study, 90 patients (age between 18 to 65) who     are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in     the study after obtaining a written informed consent from their parents or guardians.      The investigators divide our patients randomly into two equal groups.      -In the budesonide group patients underwent a therapy with nebulizing Budesonide at a dose of     1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation. After     extubation patients received nebulizing budesonide via oxygen mask at the same dose every 12     hours for 48 h.i In dexamethasone group intravenous dexamethasone was administered to patient     at a dose of 0.15 mg/kg before extubation. After extubation, the administration of     intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.      Another anesthesiologist who is unaware about kind of medication, will evaluate the patients     for severity of stridor. We will record the vital sings and grade of stridor every 6 hour.     Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were     recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60     min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with     the aid of stethoscope) was recorded within 48 hr of extubation   "
109373|NCT01854502|"     The purpose of this study is to compare the effects of two new family-based oral health     promotion programs with the routine program in use earlier in Vantaa public dental service.     The children born in 2008 were followed from their first visit to public dental service at     the age of 6-12 months to their dental examination at the age of 2-2½ years. The outcome     measures are the colonization of mutans streptococci in dental plaque, dental caries, and the     oral health habits of two-year-olds.   "
109374|NCT01854489|"     This study is aimed to examine the possible interactions of sublingual and intravenous     buprenorphine with rifampicin.   "
109375|NCT01854476|"     Patients on chronic treatment with hemodialysis have an arterio-venous fistula which enable     the insertion of two large gauge needles. At the end of dialysis the needles are extracted     and continuous pressure is needed to stop the bleeding. Time to bleeding cessation is     different between patients and may be up to 20 minutes. Acquired coagulopathy in patients on     chronic hemodylasis is a well known entity. The coagulopathy is multi-factorial including     uremic thrombocytopathia, the presence of anemia, the use of anti-platelets and/or     anti-coagulation drugs and the regular use of heparin during dialysis. Tranexamic acid     (Hexakapron) is an anti-fibrinolytic drug that has a proven efficacy in reducing blood loss     at different clinical settings. The drug may be given systemically (PO/IV) or applied locally     on the site of injury.      The aim of the study is to assess the efficacy and safety of a pad gauze dressing containing     tranexamic acid.      Study design:      A Double-blind study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular     pad-gauze. The type of dressing for each dialysis session will be decided in a random manner.     In each dialysis session only one type of dressing will be used for both insertion points.      Protocol for applying the dressing:      Following the needle extraction either dressing A or B will applied with slight pressure     for 2 minutes. If bleeding stops it will be the end of session.      If bleeding persists than another dressing of the same kind is applied with slight pressure     for 4 minutes. If bleeding stops it will be the end of session.      If bleeding persists than another dressing of the same kind is applied with slight pressure     for 6 minutes. If bleeding stops it will be the end of session.      If bleeding persists than it will be consider a failure and a regular measures will be used     until bleeding stops.      Each session will be documented in the patient's case report file (CRF). The primary end     point of the study: Time to bleeding cessation   "
109376|NCT01854463|"     In many observational studies, vitamin D deficiency is related to glucose intolerance and     diabetes. But there little randomized, controlled interventional studies that evaluate the     effect of vitamin D in type 2 diabetes.      Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2     diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and     bone turnover markers.   "
109377|NCT01854450|"     Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal     position in anterior.      Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the     fetal head.   "
109378|NCT01854437|"     Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for     control of Hyperphosphatemia are used. The aim of this study was to assess the effect of     magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its     side effects in hemodialysis patients.   "
109379|NCT01854424|"     Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and     associated with outcome in different diseases. In previous study, we have demonstrated the     presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their     association with patient outcome. The purpose of this multicentric observational prospective     study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS     (survivors vs. non survivors) and to confirm their association with 28-day mortality.   "
109380|NCT01854411|"     The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into     mature breastmilk that could allowed breastfeeding during a long time   "
109387|NCT01854320|"     The primary goal of this project is to determine if an innovative behavioral weight loss     program that incorporates new developments from the field of behavior therapy produces     superior weight control than standard behavioral treatment. A sample of 200 adults from the     community are participating in this study.   "
109381|NCT01854398|"     The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been     reported, and improvement of diastolic function after continuous positive airway pressure     (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by     supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3     months of CPAP therapy in OSA patients will significantly improve diastolic functional     parameters measured by exercise stress echocardiography. Patients with severe OSA     (Apnea-hypopnea index > 30) will be included in this study, and randomized to CPAP versus     sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity,     24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP     therapy and parameters will be compared.   "
109430|NCT01853644|"     This phase II trial studies how well tivozanib works in treating patients with recurrent     ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
112693|NCT01810874|"     The purpose of this study is to determine whether the extraperitoneal approach is better than     the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging     of endometrial or ovarian cancer.   "
109382|NCT01854385|"     This phase II evaluation of sumatriptan as a treatment for post traumatic headache (PTH) will     examine the methods and approach necessary to take the next step to a phase III trial. The     sample will include 40 persons with mild complicated, moderate or severe TBI who will be     recruited from patients discharged from the acute rehabilitation unit as well as outpatient     clinics and the community who are between 3 and 24 months of injury and will be followed over     3 months. The investigators plan to enroll those who have moderate to severe headache with     frequency of at least four and up to a maximum of fifteen total headache days per month and     at least three months after discharge from hospital. The investigators will use headache     diaries to track the headaches for a month. If subjects still have significant headache, the     investigators will instruct them in the use of sumatriptan 100 mg. to treat headaches. The     subjects will continue to keep daily headache diaries. The investigators will evaluate them     at baseline, Day 30 and Day 90. Each subject will receive weekly telephone follow up calls     from the research staff. The investigators will measure pain severity, duration, recurrence     of headaches, and side effects and how well persons with TBI can use headache diaries.   "
109383|NCT01854372|"     To estimate the I-year progression-free survival probability in patients up to 70 years of     age with previously untreated diffuse large B-celllymphoma (DLBCL), or with intermediate     (Burkitt-like) lymphoma, whose tumor cells show MYC rearrangement, and who are treated with     alternating cycles of Rituximab-HCV AD and Rituximab-Methotrexate-Cytarabine, in concert with     optimal supportive treatment including Pegfilgrastim, prophylactic antimicrobials, and close     clinical follow-up.   "
109384|NCT01854359|"     Background:      - The Idebenone in Patients With Primary Progressive Multiple Sclerosis (IPPoMS) trial tested     a new drug for multiple sclerosis. In the IPPoMS trial, participants took either idebenone or     placebo. Researchers want to give idebenone to all participants for 1 year. It is still not     certain whether idebenone can slow the progression of multiple sclerosis, but this study may     help answer that question.      Objectives:        -  To provide idebenone to all participants on the IPPoMS trial.        -  To collect data on the safety and effectiveness of idebenone for primary progressive          multiple sclerosis.      Eligibility:      - Individuals at least 18 years of age who have completed 3 years in the IPPoMS trial.      Design:        -  The first study visit for this trial will happen on the same day as the last visit for          the IPPoMS trial.        -  Participants will provide a blood samples and will have a lumbar puncture. They will          also receive a new supply of idebenone to take three times a day with food. They will          keep a diary to report on any side effects.        -  After this first treatment visit, participants will have two follow-up visits to the NIH          6 months apart. These visits may be scheduled over multiple days. Participants will          provide blood and urine samples. They will also have imaging studies of the brain and          spine.        -  Participants will have phone calls with the study researchers to provide updates on          their condition and any side effects.   "
109385|NCT01854346|"     This trial investigates the behavioral effects of manualized social skills training (KONTAKT)     in children´s and adolescents with high-functioning autism spectrum disorder with psychiatric     comorbidity in a RCT, multicenter study. N = 288 are recruited from 10 child and adolescent     psychiatric clinics in Stockholm County. The examination of genetic variants as predictors     for outcome and a qualitative study of KONTAKT complete the trial.   "
109386|NCT01854333|"     Autism spectrum disorders (ASD) are early onset chronic conditions coined by deficits in     social reciprocity, communication and stereotypic interests and activities. Other functional     impairments such as mental retardation, ADHD, known genetic syndromes and epilepsy are     frequent coexisting problems. ASD cause considerable suffering for the affected individuals     and burden for their families. With an estimated prevalence exceeding 1%, recent     population-based studies suggest that ASD are no rare phenomena. Lifetime societal costs for     services and support, together with the opportunity costs of lost productivity in a     prototypic developed country are estimated SEK 15.6 million for someone with and SEK 10.3     million for a person without co-existing mental retardation. Despite ongoing efforts, no     diagnostically informative biomarker has yet been identified for ASD. The development,     refinement and evaluation of behavioral assessment tools has therefore been decisive to     progress and quality assurance in ASD clinical practice and research. The most widely used     and thoroughly evaluated instruments for ASD in international child mental health are the     Autism Diagnostic Interview- Revised (ADI-R) and the Autism Diagnostic Observation Schedule     (ADOS). The ADI-R and ADOS are deemed highly by the ASD expert community and thus commonly     labeled as being the gold standard in ASD diagnostics. Although, Swedish translations of     the ADI-R and ADOS exist, a Swedish standardization and cross-cultural validation is still     lacking, impeding good clinical practice and research prerequisites for ASD in Sweden. The     applied project seeks to broadly establish reliability and validity of the Swedish     translations of the ADI-R and ADOS in order to enhance evidence-based clinical practice and     stimulate internationally competitive ASD research in Sweden.   "
110446|NCT01840345|"     This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases     pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will     be a useful adjunct to opioid treatment in chronic neuropathic pain.   "
109388|NCT01854307|"     Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal     invasive cardiac output monitoring is a key method to guide fluid therapy. More operations     are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled     with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output     monitoring, therefore minimal cardiac output monitoring is not recommended during     laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy     and therefore facilitate for goal directed fluid therapy.   "
109504|NCT01851941|"     The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC)     with regional lymph node metastasis is still in the area of controversy. The aim of this     study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional     5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with     regional lymph node (LN) metastasis.   "
111716|NCT01823913|"     This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet     of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of     amlodipine and valsartan (reference formulation) for single dose in healthy volunteers   "
109389|NCT01854294|"     GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that     controls the development, monitoring and correction of the human nervous system. Neurological     diseases are multisystem, multifactorial, and single target drugs are ineffective. Genervon's     Master Regulators play a significant role in embryonic/fetal nervous system development and     are potent disease modification drug candidates modulating many pathways including     inflammation, apoptotic, and hypoxia. The study drug is an regulatory peptide with a sequence     identical to one of the active sites of human Motoneuronotrophic Factor and is manufactured     by solid phase synthesis. Pre-clinical research indicates it to be a neuro-protective agent     in animal models of ALS, motorneuron diseases, PD, other neuro-degenerative diseases and     stroke. GM604 controls and modulates over many known and significant ALS genes with positive     effects interactively and dynamically through multiple pathways, and up to twenty-two     biological processes, including neuro-protection, neurogenesis, neural development, neuronal     signaling, neural transport, and other processes. GM6 is not a cocktail of drugs, but one     master regulator peptide drug that functions through multiple pathways. Genervon hypothesized     that studying the biomarkers of protein expressions of these ALS genes such as SOD1 and the     protein expression of substances such as tau, NF-H, Cystatin C which were indications of     degeneration of neuron in the CSF collected from ALS patients will provide information of the     possible GM604's mechanisms of action in treating ALS. 1. This pilot trial is designed to     test proof of principle, i.e. determine if a 2-week IV bolus treatment with this agent can     (1) change ALS protein expression (target biomarkers and efficacy biomarkers) after treatment     (2) have preliminary effects measures of ALS disease clinical progression.      Study Objectives are:        1. To test the safety and tolerability of GM604 in a population of ALS patients.        2. To test for changes in ALS biomarkers before and after treatment.        3. To determine preliminary effects of injections of GM604 on measures of ALS disease          biomarkers and clinical progression   "
109390|NCT01854281|"     The aim of this study is to determine whether catheter-based closure of patent foramen ovale     is effective in preventing paradoxical embolization of nitrogen bubbles after simulated     dives.   "
109391|NCT01854268|"     Cough is a defensive behavior that involves three stages. A large inspiratory phase, a     compression phase where the vocal folds close and subglottal pressure is developed, and an     expiratory phase. Cough serves to protect the upper and lower airways from material such as     liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary     and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that     is generated secondary to a stimulus in or near the airway. There has been some research     regarding the differences between voluntary and reflex cough. However, no research has     described the differences in airflow or movement pattern (kinematics) between the two types     of cough. This study seeks to determine the respiratory kinematics and airflow differences     between voluntary and reflex cough in healthy participants.   "
109392|NCT01854255|"     A prospective series of patients with recurrent gastric cancer will be treated with three     cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the     form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be     assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the     procedure will be assessed.   "
109393|NCT01854242|"     The purpose of this research study is to understand the relationship between inflammatory     bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been     established to have an association with IBD with clinical and histologic features that mirror     those of Crohn disease. Development of the disease seems to be related to the defect of     neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In     the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal     symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have     similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in     patients with GSD type Ia versus the general population.   "
109394|NCT01854229|"     The Prometra Pump is approved by the FDA for use in the United States. The purpose of this     study is to collect long-term safety data on the Prometra Pump.   "
109395|NCT01854216|"     To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine     in Japanese and Caucasian female and male healthy subjects.   "
109396|NCT01854203|"     Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of     treatment-related death and severe acute toxicity. The survival benefit of adding concurrent     chemotherapy to intensity modulated radiation in patients with locoregionally advanced     nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with     radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.   "
109397|NCT01854190|"     The purpose of this study is to determine the prevalence of obstructive sleep apnea and     associate it with the endothelial function behavior in patients with resistant hypertension.     Two groups will be evaluate, one presenting uncontrolled high blood pressure, and other, with     controlled blood pressure by drugs.   "
109407|NCT01854060|"     The prevalence of IBS in the community has been reported in numerous cross-sectional surveys.     However, less is known about the incidence of IBS ,mainly due to its slow development and to     patients under-reporting. Furthermore, only one study has analyzed data concerning potential     risk factors for the diagnosis of IBS. The investigators will examine the incidence of IBS in     a large cohort of young adults and will look at the association of socioeconomic,     anthropometric and occupational factors with IBS incidence.   "
109408|NCT01854047|"     Primary Objective:      To evaluate the efficacy of different doses and regimens of dupilumab in participants with     moderate to severe uncontrolled asthma.      Secondary Objective:      To evaluate different doses and regimens of dupilumab in participants with moderate to severe     uncontrolled asthma, with regard to:        -  Safety and tolerability        -  Dupilumab systemic exposure and anti-drug antibodies   "
109398|NCT01854177|"     In previous studies we demonstrated that endogenous opioids (inhibitory neuropeptides)     modulate the perception of breathing difficulty in patients with chronic obstructive     pulmonary disease (COPD) (ERJ 2009;33:771; J COPD 2011;8:160). Recently, we found that     antagonism of substance P (an excitatory neuropeptide) with aprepitant did not affect the     perception of breathing difficulty. However, after administration of aprepitant, blood levels     of both substance P(+ 54 ± 39%) and beta-endorphin (+ 27 ± 17%) increased significantly. As     these blood levels reflect cellular/tissue activity, we postulated that the concomitant     release of excitatory (substance P) and inhibitory (beta-endorphin) neuropeptides had     opposing effects (counterbalanced each other) on the perception of breathing difficulty.      The objective of the present study is to further examine the possible role of substance P on     the perception of breathlessness. We propose to administer oral aprepitant and oral placebo     in a randomized clinical trial in patients with COPD. However, four hours after patients take     these medications, intravenous naloxone will be administered in order to block the effects of     endogenous opioids (beta-endorphin) on opioid receptors. Five minutes later, patients will     breathe thru a tube with fine wire mesh to provoke breathing difficulty, and then provide     ratings of the intensity and unpleasantness of breathlessness every minute.      The two competing hypothesis of the study are:        1. if breathlessness ratings with aprepitant/naloxone = placebo/naloxone, then substance P          has no effect on perception of breathing difficulty;        2. if breathlessness ratings with aprepitant/naloxone ≠ placebo/naloxone, then substance P          has an effect on perception of breathing difficulty.   "
109399|NCT01854164|"     This study was conducted to investigate the effects of daily supplementation of hydrolyzed     ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).   "
109692|NCT01850407|"     Children are typically inadequately prepared for the sexual abuse medical examination.     Caregivers report lack of examination knowledge as a barrier to preparing their children. The     purpose of this study was to determine if informational leaflets provided prior to the     examination are helpful to caregivers in preparing their children.   "
109400|NCT01854151|"     Variable and poor-quality drug labeling has been cited as a leading cause of medication     errors and adverse drug events, especially in the context of low health literacy. This is a     particularly important issue in pediatrics as more than half of US children are exposed to     one or more outpatient medications in a given week, and studies suggest that over half of     caregivers make errors when dosing liquid medications for children. Our study objective is to     identify evidence-based strategies for labeling and dosing prescription and over-the-counter     pediatric liquid medications in order to promote safe, appropriate use, as well as to inform     state and federal policy standards. We hypothesize that a health literacy-informed labeling     and dosing strategy will result in improved parent ability to administer medications     prescribed to their young children.   "
109401|NCT01854138|"     Determine the extent to which application of the Prevena vacuum system to clean surgical     incisions immediately following surgical procedure (total hip or total knee arthroplasty)     will reduce the rates of:        -  readmission to hospital for surgical intervention due to wound complications        -  seroma        -  hematoma        -  infection compared to group of patients whose wounds were covered with traditional gauze          dressings.   "
109402|NCT01854125|"     Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in     liver cirrhosis patients with refractory ascites are very wretched. The objective of this     study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem     cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis     patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was     confirmed, and several clinical studies have applied MSCs to eliminate the progression of     fibrosis. In this research the investigators will study the affect and influence of MSCs in     the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.   "
109403|NCT01854112|"     Radiation therapy, total skin electron therapy (TSET), achieves a high response rate and is     an effective treatment for cutaneous T-cell lymphoma affecting the superficial region 1. One     the most widely used TSET techniques consists of six dual fields initially developed at     Stanford University 2. Dosimetrically, TSET at energies of about 3-7 MeV at the surface of a     standing patient may result in significant dose variations due to variable skin distance,     self shielding, irradiated fields overlapping and patient motion. Deviations occur from the     prescription dose up to 40% and the surface dose inhomogeneity as much as 90% in body areas     such as the perineum and eyelid, are revealed in the literature. To improve this condition, a     selection of patients with advanced skin disease and regional extension could be cured by a     combination of TSEB and photon beam irradiation.      Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length     of up to 160 cm, continuously in a helical pattern without the need for field junction. Total     marrow irradiation (TMI) via HT with low toxicities for bone marrow transplantation of Asia     multiple myeloma patients could be feasible . A study of HT for total scalp irradiation has     also shown that the employment of directional and complete blocking on the inner structures     can effectively force the tangential delivery of the majority of beamlets to the PTV, which     can limit the treatment depth.      Using HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSI     technique to increase dose delivery and decrease toxicities could be a workable and feasible.     Here, we applied TSI via HT (HITS) for a woman with T cell lymphoma failure by chemotherapy,     topic UV irradiation and local radiotherapy (RT) in MMH to overcome the surface dose     inhomogeneity by conventional RT. Additionally, we will compare the advantages and     disadvantages between the plan of HT and conventional RT for TSI.   "
109404|NCT01854099|"     Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly     vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation.     Patients will then be randomized to one of three arms: 1). standard temozolomide     (TMZ)(200mg/m^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard     TMZ (200mg/m^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3).     dose-intensified TMZ (100 mg./m^2 for 21 days) with vaccine on day 22-24 of each monthly     cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ     cycles and continue after TMZ cycles until progression or death.   "
109405|NCT01854086|"     The purpose of the study is to provide information about the rate of response and persistence     to drug therapies for osteoporosis. Another issue examined in this study refers to the     preferences and concerns about future treatments in patients during drug holiday.   "
109406|NCT01854073|"     To determine the value of using Hyoscine as an antispasmodic drug for the management of     prolonged labor in nulliparous women at term.   "
109444|NCT01853462|"     The purpose of this study is to determine the comparative effectiveness of proprioceptive     neuromuscular facilitation and balance exercise programs for the rehabilitation of ankle     sprain injuries.   "
109409|NCT01854034|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the drug is being studied. It also means that the FDA has not     yet approved the drug for your type of cancer or for any use outside of research studies.      It has been found that some people with NSCLC have a change (mutation) in a certain gene     called the EGFR gene. This mutated gene helps cancer cells grow. The majority of NSCLC     patients with EGFR mutations achieve good outcomes with erlotinib or other EGFR inhibitor     therapies, with a high response rate, prolonged progression-free survival and possibly     improved overall survival from therapy. However, the 4% of EGFR mutant patients that harbor     an exon 20 insertion mutation historically have reaped little benefit from EGFR-directed     therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially     erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is     ideal for studying other targeted therapeutic strategies that could affect the oncogene     mutation in EGFR via alternative mechanisms.      AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This     drug has been used in other research studies. Information from those other research studies     suggests that AUY922 may be effective in killing cancer cells in patients with exon 20     insertion mutations in EGFR.      The purpose of this study is to test the safety of AUY922 and determine how well AUY922 works     for participants with advanced NSCLC and exon 20 insertion mutations in EGFR.   "
109410|NCT01854021|"     Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced     immunosuppression has been implicated in the development of post-operative septic     complications and neoplasm metastasis. General anesthesia is considered to not only suppress     surgical stress, but also affect the immune function directly，such as altering the number and     activity of immune cells. It is reported that some anesthetics increase susceptibility to     tumor metastasis, apparently by suppressing natural killer cell activity. Different     anesthetic techniques and anesthetics used in anesthesia have shown different effects on     immunity. Many of the studies were animal trials or performed in vitro; in addition, most are     focused on a single drug. To date, there is little published prospective clinical research     designed specifically to investigate the effects of different general anesthetic technique on     immune function in patients with oral malignant tumors. The aim of this study is going to     characterize the immune response of patients undergoing surgery for tongue cancer under 3     types of general anesthesia.   "
109411|NCT01854008|"     The aim of this study was to assess the effectiveness of the implementation of walking urban     circuits in increasing the level of physical activity and exercise capacity in severe chronic     obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary     rehabilitation program.   "
109412|NCT01853995|"     The aim of the current controlled trial was to assess the possible net skeletal and dental     effects of FLMGM treatment in relation to growth with emphasis on the contribution of     skeletal and dental changes to sagittal correction of Cl II/1 malocclusion.      The null hypothesis stated that there were no significant differences in dentoskeletal     changes between FLMGM treated group and control untreated group.   "
109413|NCT01853982|"     This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the     safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV     piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult     participants .   "
109414|NCT01853969|"     This study will investigate how soon a patient's typing proficiency returns to their     pre-operative levels following carpal tunnel release surgery. In order to determine this,     patients will undergo typing tests at different time points that will record their typing     accuracy and speed. The results will then be compared to determine on average how soon a     person returns to their pre-operative baseline results.   "
109415|NCT01853956|"     The objective of this study was to confirm if two formulations of alprazolam (tablets) are     bioequivalent.      Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg     (Pharmacia & Upjohn). One tablet was the single dosage.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 28 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
109416|NCT01853943|"     Transradial coronary procedures are gaining in popularity worldwide. A possible complication     of transradial approach is the occlusion of the radial artery that in most cases is     asymptomatic. However the investigators do not know if the radial artery occlusion may impact     over the muscle force of the hand or fingers.      To evaluate if transradial approach for percutaneous coronary procedures may affect muscle     force of the hand, thumb and index finger the investigators use a standardized hand-grip     manometer and a pinch gauge before the transradial procedure, the day after the procedures     and after few months.   "
109417|NCT01853930|"     Age-related macular degeneration (AMD) is the most common visual impairment in persons over     50 years of age. It has been estimated that 1 in 3 individuals over 75 years of age and 1 in     30 individuals over 52 years of age are affected by AMD. The deficits in visual function as a     result of this disease affecting the central retina are debilitating, as individuals lose     their ability to carry out many of their daily activities that require resolving fine spatial     details. The investigator's previous studies have shown that training with oculomotor control     exercises significantly increases reading speeds in patients with AMD. In the proposed study,     the investigators will examine whether these training exercises are effective when practiced     at home.      In Phase 1, the investigators will develop a standardized user-friendly, Web-based platform     that will allow patients to easily self-administer training exercises. The software platform     will be designed to automatically choose the appropriate exercises based on a patient's     previous performance, run the training exercise, and collect performance data into a     universal patient data file. In Phase 2, the platform will be tested in two settings: in     standard clinical rehabilitation practice and in the patient's home. Reading outcomes in the     two settings will be compared. The investigators will recruit 60 patients per year for each     of the three years for Phase 2 of the study. Half of these patients will be assigned to the     Clinic Training Group, while the other half will be assigned to At-home Training Group. For     all patients, three assessments will be taken: at baseline, after 1 month, and after 2 months     of training.      The investigators will compare reading outcomes to assess the roles of feedback versus the     role of frequent available practice. Because of the extensive cost and clinical resources     required for vision rehabilitation, it is critical to determine whether the training program     can be made less expensive, but as effective, when it is self-trained. If the investigators     demonstrate the utility of at-home practice, clinical facilities and therapists' time can be     made available for those activities requiring face-to-face contact   "
122525|NCT01682200|"     This study was conducted to determine the effects and side effects of ProOxy facial spray in     the treatment of acne.   "
109418|NCT01853917|"     The purpose of this study is to evaluate why the majority of HIV infected women in the Harris     County Health District system who are pregnant do not come to clinic for their HIV disease     after they have a baby through questionaires administered prepartum and questionaires and     structured interviews postpartum. The study will ask subjects questions about HIV, drug use,     depression and social problems.   "
109419|NCT01853904|"     Bronchoalveolar lavage (BAL) is a common technique among pulmonologists. Its goal is to     collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a     bronchus, instilling saline, and removing the saline via suction. Two techniques are     currently used for suctioning: syringe based and channel suction.      The investigators concern is that channel suction creates too much force and there is     collapsing of the airways which results in decreased fluid removal as well as cell sampling.     The investigators propose that syringe based suctioning will not only return more of the     instilled fluid but also more cells from the alveoli.   "
109420|NCT01853891|"     With the advent of electricity, light at night has become a ubiquitous part of our society.      The main purpose of this study is to determine whether sleeping with dim light (40 lux), the     brightness of a night light) in your bedroom for 5 consecutive nights will result in     increased markers of inflammation in the blood compared to sleeping in darkness during the     night in patients with obstructive sleep apnea (OSA).      A secondary aim is to examine the effects on insulin sensitivity, other blood proteins, and     RNA molecules as a result of sleeping with dim light. RNA molecules are substances in blood     that dictate what type of proteins the body should make.   "
109421|NCT01853878|"     The purpose of this study was to test a potential new kind of anti-cancer treatment, called     PRAME immunotherapy in resected patients with lung cancer.      As of 18 July 2014, the recruitment was stopped prematurely and the study was unblinded. Only     patients on active treatment will have the option to continue in the study. Patients     randomised to the Placebo group were withdrawn.      There will no longer be an active follow-up of patients after discontinuation or completion     of the treatment. The study will end 30 days after the last dose will be administered.      As a result, primary and secondary objectives will not be assessed as planned. All clinical     and safety data collected in the study will be analysed descriptively. For each biological     sample already collected in the scope of this study and not tested yet, testing will not be     performed by default, except if a scientific rationale remains relevant despite the premature     termination of the study.   "
109422|NCT01853865|"     The present study is conducted, to elucidate the value of follow-up examinations in     endometrial cancer patients. Specifically the objective is to compare hospital-based     follow-up examinations with instruction in self-referral in stage I endometrial cancer     patients.      The investigators hypothesize that the intervention, instruction in self-referral, will:        -  reduce fear of recurrence        -  improve quality of life        -  improve cost-utility        -  not affect disease-free survival.   "
109423|NCT01853852|"     GR181413A/AT1001 (migalastat hydrochloride) is a low molecular weight iminosugar, an analog     of the terminal galactose group that is cleaved from the substrate GL-3. This compound was     researched and developed as a drug for treatment of Fabry disease. This study, MGM115806,     will be the first administration of GR181413A/AT1001 to Japanese subjects to investigate the     safety, tolerability and pharmacokinetics of single oral doses in healthy Japanese adult     subjects. Approximately 12 subjects will receive three treatments of 50, 150 and 450 mg     GR181413A/AT1001 under fasted conditions plus placebo in a dose ascending crossover design.     Serial pharmacokinetic samples will be collected and safety assessments will be performed     following each dose. The pharmacokinetics and dose proportionality of GR181413A/AT1001 after     single oral doses of GR181413A/AT1001 at the dose levels of 50, 150 and 450 mg under fasted     conditions will be assessed.   "
109424|NCT01853722|"     This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping     of the periocular region.   "
109425|NCT01853709|"     Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel     cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common     problem that occurs up to 20% of procedures. This fact has a deep clinical and economical     impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of     lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and     hospitalized patients are predictive factors of inadequate colonic preparations. These     circumstances have promoted multiple clinical trials, however there is no consensus about the     optimal strategy for colonic cleansing. Education in colonic preparation has obtained     conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the     commonest preparations used with a similar efficacy. However, the large volume to ingest (4     litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels     in sodium and phosphate which contraindicate its use in elderly patients and / or with     comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume     of polyethylene glycol thereby improving the tolerance and right colon preparation.      The aim of this study is to compare the efficacy of a multidisciplinary approach (education,     fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a     conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of     hospitalized patients.   "
109426|NCT01853696|"     Graft rejection has traditionally been one of the leading causes of cornea transplant     failure. To help prevent rejection, corticosteroid eye drops are used for an extended period     after transplant surgery. The purpose of this study is to compare the efficacy and side     effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea     transplant) surgery.   "
109427|NCT01853683|"     Appendicitis is one of the most common surgical problems in children, with 20-35% of patients     having perforated by the time they present to a doctor. In these cases, the patient is often     treated non-surgically with antibiotics. Once a patient has improved, it is not known whether     it is better to perform an interval appendectomy (IA) or to continue a watchful waiting     approach. The purpose of this trial is to determine if expectant nonoperative management     (watchful waiting) is not inferior compared to IA management after successful conservative     treatment of appendiceal mass at admission.   "
109454|NCT01853332|"     The purpose of this study is to determine the effects of individual characteristics, life     stresses, and relationships over time on psychosocial outcomes (e.g. marriage, parenting,     work) and physical health   "
109428|NCT01853670|"     The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT     imaging to track the dose delivered in head and neck cancer patients, to assess the benefit     of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on     kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote     access tools (preferably internet-based) so that the MD can approve these plans in real time.   "
109429|NCT01853657|"     The main objective is to access efficacy of first and second line antiretroviral therapy     (ART) and its determinants in patients treated at the Komfo Anokye Teaching Hospital in     Kumasi (KATH), Ghana, and to compare the clinical, virological and immunological efficacy of     second line ART in patients who were switched after virological failure compared to patients     who were switched after clinical or immunological failure.      Other specific study objectives are:        1. To establish an HIV Cohort Study at the study site.        2. To assess the rate of virological failure among patients on first line therapy        3. To compare the clinical, immunological and virological efficacy of second line          antiretroviral therapy amongst patients randomised to virological monitoring whilst on          first line compared with those monitored routinely using clinical and immunological          monitoring.        4. To assess the incidence and outcome of tuberculosis (TB) and other opportunistic          infections in patients treated at the Komfo Anokye Teaching Hospital HIV services        5. To obtain parameters for quality of care, e. g. performance of TB screening procedures        6. To develop strategies to minimise treatment failures, on the basis of the results of the          study        7. To generate a large prospective second-line ART cohort, to serve as basis for further          research projects        8. To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital        9. Capacity building: epidemiology, medical documentation and data base management.          Enrollment of one PhD and one Master student   "
109431|NCT01853631|"     Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute     lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as     lymphoma or leukemia). The lymphoma or leukemia has come back or has not gone away after     treatment.      The body has different ways of fighting infection and disease. No one way seems perfect for     fighting cancers. This research study combines two different ways of fighting disease,     antibodies and T cells, hoping that they will work together. Both antibodies and T cells have     been used to treat patients with cancer. They have shown promise, but have not been strong     enough to cure most patients.      T cells can kill tumor cells but normally there are not enough of them to kill all the tumor     cells. Some researchers have taken T cells from a person's blood, grown more of them in the     laboratory and then given them back to the person.      The antibody used in this study is called anti-CD19. It first came from mice that have     developed immunity to human lymphoma. This antibody sticks to lymphoma cells because of a     substance on the outside of these cells called CD19. CD19 antibodies have been used to treat     people with lymphoma and leukemia. For this study, anti-CD19 has been changed so that instead     of floating free in the blood it is now joined to the T cells. When an antibody is joined to     a T cell in this way it is called a chimeric receptor.      In the laboratory, the investigators found that T cells work better if they also add proteins     that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells last longer     in the body but not long enough for them to be able to kill the lymphoma cells. The     investigators believe that if they add an extra stimulating protein, called CD137, the cells     will have a better chance of killing the lymphoma cells.      The investigators are going to see if this is true by putting the CD19 chimeric receptor with     CD28 alone into half of the cells and the CD19 chimeric receptor with CD28 and CD137 into the     other half of the cells. These CD19 chimeric receptor T cells with CD28 and with or without     CD137 are investigational products not approved by the FDA.      The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to     see how long the T cell with each sort of chimeric receptor lasts, to learn what the side     effects are and to see whether this therapy might help people with lymphoma or leukemia.   "
109432|NCT01853618|"     Background:      - Tremelimumab is a cancer treatment drug that helps the immune system recognize and destroy     cancer cells. Researchers want to see if it can be used to treat advanced liver cancer. The     drug will be given with one of two types of treatment for liver cancer. The first type,     transarterial catheter chemoembolization (TACE), injects chemotherapy drugs into the tumor     through the main blood vessel that is feeding it. That blood vessel is then closed off to     help keep the drugs in the tumor longer. The second type, radiofrequency ablation (RFA), uses     a heated probe to destroy the tumor tissue. Researchers want to study how safe and effective     these treatments are with the study drug.      Objectives:      - To test the safety and effectiveness of Tremelimumab with TACE or RFA for advanced liver     cancer.      Eligibility:      - Individuals at least 18 years of age who have advanced liver cancer that has not responded     to other treatments.   "
109433|NCT01853605|"     Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive     Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast     augmentation, reconstruction, or revision   "
109434|NCT01853592|"     Background:      - Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and     radio waves to take pictures of the body. To help the images show up more clearly, a contrast     agent is injected into a vein. Researchers are interested in finding contrast agents that can     help show problems with the blood vessels around the heart. They want to test an agent called     Gadofosveset Trisodium to see how it works in MRI scans.      Objectives:      - To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.      Eligibility:      - Healthy volunteers between 18 and 45 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide blood samples before the scanning sessions.        -  Participants will have an MRI scan after the screening visit. They will have a dose of          the contrast scan before the study.        -  Participants will return for one additional MRI scan within 1 to 2 months of each scan.          Different doses of the contrast agent will be used for each scan.        -  An additional blood sample will be collected within 1 week of the second MRI scan.   "
109435|NCT01853579|"     Mild thyroid failure is a common condition among older adults and has been associated with     numerous adverse effects on health, such as cardiovascular disease, cognition disturbances     and muscular problems. Mild thyroid failure has also been associated with an increased risk     of developing depression. To date, only few studies have investigated the effect of thyroid     hormone replacement on depression in patients with mild thyroid failure. This study therefore     aims to assess whether thyroid hormone replacement in older adults with mild thyroid failure     is associated with a decrease in the presence of depressive symptoms. This study forms a     substudy of a large international study on thyroid hormone replacement in older adults with     mild thyroid failure (the TRUST study).   "
109455|NCT01853319|"     This is an open-label phase III study of regorafenib in patients with metastatic colorectal     cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this     study is to provide additional information about the safety profile of Regorafenib.   "
109456|NCT01853306|"     This is a 3 part phase 1 study to evaluate the safety, pharmacokinetic and oral     bioavailability of veliparib in subjects with solid tumors.   "
109436|NCT01853566|"     The growth hormone (GH) secretion declines gradually with age, with studies demonstrating a     progressive reduction of 14% secretion per decade of life beginning in the second decade.     Other studies suggest a disruption in GH secretion in elderly people. These findings suggest     a possible association between growth hormone deficiency (GHD) and the ageing process.GH     replacement is well known to improve body composition, leading to a decrease in total body     fat and an increase in lean body mass. However, GH replacement has only shown an effect on     muscle strength in GH-deficient adults subjected to long-term GH therapy. Few studies have     evaluated the effect of GH replacement on muscle strength in elderly people engaged in a     program of exercise training.Our purpose is to evaluate the effect of GH therapy on muscle     strength in healthy, non-sedentary men over 50 years old.   "
109437|NCT01853553|"     The proposed research will determine the effectiveness of blocking aldosterone for improving     the health and function of arteries in patients with autosomal dominant polycystic kidney     disease (ADPKD). The study also will provide insight into how blocking aldosterone improves     artery health by determining the physiological mechanisms (biological reasons) involved.     Overall, the proposed research will provide important new scientific evidence upon which     physicians can base recommendations to patients with ADPKD to decrease risk of developing     cardiovascular diseases.   "
109459|NCT01853267|"     TITLE Perianal Abscess Packing (PAP): a randomised controlled trial (Pilot study)      DESIGN Randomised controlled trial.      HYPOTHESIS In patients with perianal abscesses incision and drainage without packing the     subsequent cavity will reduce patient discomfort without increasing healing time or     recurrence compared with management involving cavity packing.      OUTCOME MEASURES        -  Length of hospital stay        -  Time to cavity healing        -  Recurrent abscess or fistula formation        -  Pain score        -  Analgesia usage POPULATION All patients older than 18 years presenting with a perianal          abscess.      ELIGIBILITY Exclusion criteria:        -  under 18 years        -  those unable to give informed consent        -  abscesses associated with Crohn's disease or other underlying causes        -  abscesses in which initial drainage is considered inadequate (if the skin is not open          sufficiently to allow drainage of the abscess cavity)      DURATION Until recruitment of subjects is complete   "
109438|NCT01853540|"     Background:        -  Pulmonary nontuberculous mycobacterial (PNTM) infection is caused by a common type of          bacteria in the environment. Although PNTM infection is most common in people with lung          diseases, it can also affect healthy people. It can be difficult to treat, and affects          parts of the body other than the lungs. For example, PNTM may affect the cilia, the          hair-like structures inside the nose and lungs that help move dirt and debris out of the          body.        -  Ciliary beat frequency (CBF) is a measurement of how fast cilia move. People with PNTM          infection have a lower CBF than healthy people. Nitric oxide (NO) is a gas in the body          that may affect CBF. People with PNTM infection produce lower amounts of NO in their          noses than healthy people. Researchers want to see if a drug called sildenafil can          increase NO production and CBF. If sildenafil can improve these measurements, it may be          a useful treatment for PNTM infection.      Objectives:      - To study the effect of sildenafil on CBF and NO levels in people with PNTM infection.      Eligibility:        -  Individuals at least 18 years of age who have PNTM infection.        -  Participants must be enrolled in a related National Institutes of Health study on          bacterial infections. The study is Natural History, Genetics, Phenotype and Treatment of          Mycobacterial Infections.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have heart and lung function tests, as well as tests of NO production in the nose. They          will provide samples of sputum and cells from inside the nose.        -  Before the first study visit, participants will collect sputum samples for 24 hours.          They will bring the samples to the study visit.        -  At the first study visit, participants will have heart and lung function tests, as well          as tests of NO production in the nose. They will provide blood, urine, sputum, and nasal          cell samples. They will also receive sildenafil tablets to take at home.        -  Participants will take sildenafil tablets three times a day.        -  The second study visit will be 7 days after the first one. The tests from the first          visit will be repeated. Participants will receive more sildenafil tablets to take on the          same schedule as before.        -  The third and final study visit will be 30 days after the first one. The tests from the          first visit will be repeated. Participants will stop taking sildenafil at this visit.        -  A follow-up phone call will be made about 2 weeks after the final study visit. This call          will ask questions about quality of life and any symptoms or side effects of the study.   "
109439|NCT01853527|"     The aim of the study is to assess presence of myocardial ischemia by contrast stress     echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD)     by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of     myocardial ischemia in such patients.   "
109440|NCT01853514|"     Primary objective is to determine the impact of messages related to conventionally grown and     organically grown produce on purchasing behaviors in low-income individuals.      Secondary objective is to assess knowledge and attitudes about conventionally and organically     grown fruit and vegetable in low-income individuals.   "
109441|NCT01853501|"     The purpose of this study is to determine whether Adipose Derived Stem Cells are effective in     the treatment of Premature Ovarian Failure (POF). Stem cell transplantation has been reported     to rescue ovarian function in a pre-clinical mouse model of chemotherapy-induced POF;     however, maintaining the survival of transplanted cells in human ovarian tissues to enable     the POF patients regain ovary function over the long-term and achieving a successful     pregnancy remain a troublesome issue. In this study the investigators are aiming to determine     whether the CD29+/CD44+ human Adipose Derived Stem Cells could later enable ovaries produce     mature oocytes.   "
109442|NCT01853488|"     Background:      After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is     observed. This leads to a osteoporosis which is connected to a high fracture risk.      Aims:      To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and     assessment of fracture risk in subjects with spinal cord injury.      Subjects:      250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord     injury will be recruited for this study. For a reference group, 500 able-bodied persons will     be measured analogously.      Methods:      Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur,     distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone     parameters of the tibia will be measured by using pQCT. All measurements will be done     unilaterally. For the assessment of potential risk factors for reduced bone stiffness after     spinal cord injury a questionnaire will be used.   "
109443|NCT01853475|"     Piperaquine tablets (coated) + OZ439 granules + TPGS granules will be co-administered in     Phase IIb (adults). However, safety and PK data (for OZ439 plus piperaquine) were obtained     using piperaquine tablets plus OZ439 as Powder in Bottle with milk. Piperaquine has not yet     been administered together with TPGS. Co-administration of piperaquine plus OZ439 as Powder     in Bottle (PIB) with milk results in an increase in OZ439 exposure (current estimate ~ 70%     due to a small drug drug interaction).      This study investigates the exposure of piperaquine and OZ439 when co-administered as     piperaquine phosphate tablets and OZ439 + TPGS prototype (a formulation close to that of     Phase IIb, but not identical), in order to select the appropriate doses for Phase IIb. The     reference treatment is piperaquine phosphate tablets + OZ439 Powder in Bottle + full fat milk   "
109445|NCT01853449|"     Dyspnea refers to the awareness of breathing discomfort that is typically experienced     during exercise in health and disease. In various participant populations, dyspnea is a     predictor of disability and death; and contributes to exercise intolerance and an adverse     health-related quality-of-life. It follows that alleviating dyspnea and improving exercise     tolerance are among the principal goals of disease management. Nevertheless, the effective     management of dyspnea and activity-limitation remains an elusive goal for many healthcare     providers and current strategies aimed at reversing the underlying chronic disease are only     partially successful in this regard. Thus, research aimed at identifying dyspnea-specific     medications to complement existing therapies for the management of exertional symptoms is     timely and clinically relevant. The purpose of this study is to test the hypothesis that     single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the     perception of dyspnea during strenuous exercise in healthy, young men in the presence of an     external thoracic restriction. To this end, the investigators plan compare the effects of     inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of     neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating     lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea     (sensory intensity and affective responses) during symptom-limited, high-intensity,     constant-work-rate cycle exercise testing with and without external thoracic restriction in     healthy, men aged 20-40 years.   "
109446|NCT01853436|"     The objective of this study is to demonstrate that acellular dermal matrix, Strattice™     Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of     breast reconstructions with implants by avoiding one more surgical step in the operating     room.   "
109447|NCT01853423|"     The objective of this study is to evaluate the safety and efficacy of a 0.1% formulation of     rapamune cream in children with Tuberous Sclerosis Complex (TSC), ages 3 years and older, who     have facial angiofibromas that would benefit from treatment.   "
109448|NCT01853410|"     The purpose of the PERCCAD Study is to investigate the effect of the gekoTM device (a     non-invasive calf muscle stimulator approved for use to improve blood flow by Health Canada)     on coronary blood flow in order to assess its potential role as a therapeutic modality for     the treatment of symptomatic coronary artery disease (CAD). This will occur in patients     already undergoing coronary angiography and percutaneous coronary intervention (PCI) as part     of their usual medical care. Further, the investigators will also assess the overall effect     on blood flow in the body using non-invasive techniques. The primary objective of the PERCCAD     study is to assess the effect of the gekoTM device on coronary blood flow in patients with     symptomatic CAD who are undergoing invasive angiographic assessment and management with PCI.     This evaluation of the gekoTM device is to be performed at the time of the patient's already     planned invasive assessment and management so that invasive data can be collected without     exposing the patient to risks other than those already associated with their planned     procedure and usual clinical care. The secondary objective of the study is to assess the     effect of muscle stimulation with the gekoTM device on endothelial function and peripheral     blood flow measured via non-invasive techniques.   "
109449|NCT01853397|"     The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment     with the Liposonix System (Model 2)using a single pass technique.   "
109450|NCT01853384|"     This study is being done to find out if an investigational product called HP802-247 can help     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by     the U.S. Food and Drug Administration (FDA).      This research is being done to compare the efficacy of HP802-247 plus compression therapy     against Vehicle plus compression therapy in achieving complete wound closure over the 12-week     treatment period. Vehicle looks the same as HP802-247 but contains no cells.      At least 440 subjects will participate. The study is going to be conducted in approximately 5     countries at approximately 50 sites across the European Union.   "
109451|NCT01853371|"     This research proposal is submitted to fulfill the requirement of the PHD degree of Community     Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi     Arabia.      Background: Cupping is an ancient treatment remedy that has been used for many centuries in     many parts of the world. In the Middle East, Wet cupping Hijama is still a popular     treatment because of its religious background. Despite of that, it still has little     scientific evidence that proves its efficacy. Many hijama healers claim that they have     observed dramatic improvement in Blood pressure control of hypertension patients. Not many     studies support that. This study should help to prove or disprove this hypothesis.      Objectives:        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure          patients.        -  To assess the incidence of wet cupping side effects in the intervention group.      Methods: The study design is a randomised controlled trial. There will be an intervention     group of high blood pressure patients who will perform hijama in addition to their usual     management, and a control group of high blood pressure patients who will receive their usual     anti-hypertension management only. There will be 4 weeks follow up period. After that, data     entry, analysis and interpretation will take place.      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients   "
109452|NCT01853358|"     The goal of our study will be to determine the clinical and biological safety of infusing     immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation     with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced     Intensity Conditioning (RIC), as a potential substitute to usual Donor Lymphocyte Infusion     (DLI), that contain the whole range of immune effectors. The trial will include several     progressive steps: dose escalation up to a level compatible with the cost-effectiveness     potential of the device and clinical situation and recombinant interleukin-2 (r-IL2)     activation of selected NK cells in vitro prior to re-infusion.   "
109453|NCT01853345|"     In this study tumor will be tested for cancer causing gene alterations such as mutations or     copy number alterations. This is called tumor profiling. A panel of experts will review the     tumor profiling results and determine whether there is a cancer-causing alteration present in     the tumor. If there is, the experts will determine if there is a targeted drug available that     could counteract this alteration. If there is an alteration identified and a targeted drug     available the panel of experts will make an individualized treatment recommendation. The     results of the tumor profiling and the individualized treatment recommendation can be shared     with the primary oncologist.   "
109458|NCT01853280|"     This pilot study seeks to evaluate initial evidence for the effect of L-methylfolate     supplementation to OROS-Methylphenidate pharmacotherapy on ADHD symptoms and associated     features in adults with ADHD, as well as tolerability of this supplementation. The     investigators will conduct a 12-week double-blind randomized placebo-controlled trial with     L-methylfolate supplementing open-label OROS-Methylphenidate (OROS-MPH). The investigators     propose to examine 40 adult (ages 18-55) subjects satisfying the DSM-IV diagnostic criteria     for ADHD.   "
109460|NCT01853254|"     This open-label, non-randomized, single arm study will provide treatment or re-treatment with     Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to     patients with chronic hepatitis C infection. Patients who have received prior Pegasys     monotherapy or combination therapy or who were considered eligible for treatment with Pegasys     in previous donor protocols will be eligible to participate in this study. Treatment will be     on investigator's decision according to the approved label for up to 48 weeks, with a 24-week     safety follow-up.   "
109461|NCT01853241|"     The small bowel is poorly suited to standard endoscopy techniques due to its anatomical     differences from the colon and the upper gastrointestinal tract. The small bowel has an     average length of 6.7 m, with a free mesentery that resists standard push to advance     endoscopy techniques. New developments in overtubes, which are placed over an enteroscope,     have revolutionized doctors ability to deeply intubate the small bowel. Three types of     'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE)     and spiral enteroscopy (SE), have been developed. Although studies have been performed on     these individual techniques, there are no studies comparing SBE and SE, the two techniques     used in Johns Hopkins.      The investigators propose performing a prospective, randomised trial, to assess the     differences between these two techniques. The question of what differences there are between     these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time     required for the procedure and the sedation requirements, are important questions to answer,     and depending on the results, would affect the investigators approach to patients with small     bowel disease.   "
109462|NCT01853228|"     The purpose of this study is to examine the safety and efficacy of decitabine in sequential     administration with cytarabine in children with relapsed or refractory acute myeloid leukemia     (AML).   "
109463|NCT01853215|"     This study is being done to evaluate intraosseous vascular access through the sternum.   "
109464|NCT01853202|"     Patients with lymphoma or cancer who are receiving chemotherapy in the outpatient setting are     at risk for blood clots which form in the veins. The occurrence of blood clots has major     implications on personal health including the need for blood thinners and monitoring,     potential bleeding, and complications related to blood clots on cardiovascular health. The     goal of this study is to determine whether aerobic exercise training is a therapeutic     strategy to offset risk of blood clots and improve quality of life among cancer patients     during chemotherapy.   "
109465|NCT01853189|"     Asthma is a highly prevalent chronic disease in children. Complementary and Alternative     Medicine research on asthma showed a potential effect on pediatric patients.      Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive     results.      The aim of study is to further explore the role of OMT on asthma in a pediatric population.   "
109466|NCT01853176|"     Background & study question:      Strategies for post-operative pain control that make use of various different types of     medicines are advantageous both for patient comfort and for minimizing the use of opioid pain     medicines and their associated side effects, which include drowsiness, nausea, and vomiting.     A key element of these strategies is wound injection with local anesthetic (numbing medicine)     at the time of surgery. Local numbing procedures are used routinely in patients undergoing     abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine, which can last several     hours. Multiple studies have shown that locally injected pain medicines achieve better pain     control, less opioid use, and faster return to normal activities, such that the use of one of     these local anesthetic medicines is the current standard of care.      Exparel is an extended-release formulation of bupivacaine that can produce local pain relief     for up to 72 hours. Studies have shown it to provide better post-operative pain control and     decreased use of opioid medications when compared to patients who did not receive any local     numbing agents. Exparel has been used successfully in a variety of surgical settings,     including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast     augmentation. Its effectiveness has by and large been established in comparison to no local     anesthetic. In this study, we seek to investigate the benefit of Exparel compared to standard     bupivacaine infiltration in patients undergoing abdominoplasty.      Study design:      Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in     this study. Consenting patients will be randomly assigned to standard bupivacaine or Exparel     by coin toss after their clinic visit. On the day of surgery, the only difference between     patients assigned to one arm or the other is the local anesthetic used. The surgery itself     and plan for general anesthesia will be similar. Both groups will have the same pain     medicines available after surgery.      Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic     needs for 3 days after surgery. For patients admitted after surgery, oral and IV narcotic use     will be collected from their inpatient medical record.      The primary outcome of interest is daily and cumulative pain scores through 3 days. A     secondary endpoint is daily and total opioid use over 3 days. Additional measures include the     time to first post-operative use of opioid medication and incidence of any adverse side     effects.   "
109467|NCT01853163|"     The purpose of the study is to further investigate the safety of six different commercially     used Gadolinium-containing contrast agents.      The study has been developed to evaluate Gadolinium retention in patients with renal function     ranging from stable to severely impaired renal function who had previously (i.e. before start     of this study) received any of the six different contrast agents within a magnetic resonance     contrast imaging procedure and who will now undergo an orthopaedic procedure that allows     collection of bone and skin samples for analysis.   "
109468|NCT01853150|"     Freezing of gait (FOG) means that patients cannot walk without any known causes, other than     parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet     suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive     procedure using electromagnetic induction to stimulate brain. Transcranial magnetic     stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim     of this study is to the therapeutic effect of rTMS for the FOG.   "
109469|NCT01853137|"     The current trial was designed to investigate the possible initial net skeletal and dental     effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1     malocclusion subjects. The null hypothesis stated that there were no significant differences     in dentofacial changes between FLMGM group and control group.   "
109865|NCT01847937|"     This project aims to develop high field MR techniques to detect nerve lesions in diabetic     patients. The MRI findings will be compared to results from conventional evaluations and     nerve conduction studies to determine the validity as part of a clinical practice.   "
122526|NCT01682187|"     This is a study of oral LY2157299 as monotherapy and in combination with lomustine in     participants with recurrent malignant glioma.   "
109470|NCT01853124|"     The objective of this study is to determine for previously healthy children who present to a     Canadian Emergency Department (ED) with acute gastroenteritis (infection or irritation of the     digestive tract); if compared with placebo, the administration of a probiotic agent     (Lacidofil) will result in a significantly lower proportion of children developing moderate     to severe disease over the subsequent 2 weeks and will not be associated with a significantly     greater occurrence of side effects.   "
109484|NCT01852942|"     This study was designed to test the hypothesis that treatment of HIV infected subjects with     losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will:        1. reverse existing lymphoid tissue fibrosis,        2. restore lymphoid tissue architecture,        3. increase the number and improve the function of peripheral and lymphatic CD4 T cells,        4. decrease levels of systemic immune activation (IA),        5. decrease size of the HIV reservoir, and        6. be safe and well tolerated.   "
109537|NCT01852474|"     In this study, the investigators aim to assess the clinical and neurophysiological effects of     a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)-     on cortical plasticity and motor learning in children with cerebral palsy. Investigators will     use different assessment techniques, such as transcranial magnetic stimulation (TMS) and     kinematics (sensors) to measure changes through the trial.   "
109471|NCT01853111|"     Many patients suffer from devastating injuries to vascularized composite tissues.     Vascularized composite tissues are blocs of functional tissue that can contain multiple     tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others.     Examples of patients with severe vascularized composite tissue defects include limb amputees,     patients with third-degree burns to the face or extremities, soldiers with     improvised-explosive-device blast injuries to the face, and others. These patients cannot be     helped satisfactorily with conventional reconstructive surgery; however, recently     vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs     became available to this patients. Unfortunately, at this juncture, patients who receive VCA     must submit to life-long regime of immunosuppressant drugs with serious side effects such as     infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune     response from the recipient's body to the transplant, while otherwise maintaining sufficient     immune function to fight infections and other threats. Transplant recipients with immune     tolerance do not need to take immunosuppression drugs. The investigators believe that they     can achieve immune tolerance in recipients of face and limb transplants.   "
109472|NCT01853098|"     The primary objective of this study is a proof-of-concept study to test whether a novel     mindfulness based intervention, Positive Affect Training (PAT), can enhance positive affect     and compassion, and decrease negative affect and feelings of depression. PAT involves a     combination of practicing mindfulness meditation and loving-kindness meditation in groups.     The goal of the research is to test the initial feasibility and efficacy in increasing     positive affect and decreasing negative affect in individuals recruited from the general     community who experience negative affect. If the training proves to be successful, we will     test the intervention, in additional studies, on individuals with dysthymic disorder and     other clinical disorders. PAT is a cost-effective, non-invasive intervention. Therefore if     effective, it could be an alternative or supplemental intervention option to existing     psychotherapy for dysthymic disorder.   "
109473|NCT01853085|"     The study will evaluate patients diagnosed with primary open angle glaucoma or ocular     hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance     with physician standard clinical practice. All treatment decisions lie with the physician.   "
109474|NCT01853072|"     The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,     0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among     diabetic subjects following cataract surgery.   "
109475|NCT01853059|"     Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This     is very successful (75% long term survival). During the course of the radiotherapy, other     organs in the pelvis may be damaged. This can lead to long-term problems with possible     changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and     incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain     during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help     with these side effects. At present, there is very little information on the effect treatment     has on a patient's quality of life, making it difficult to judge if new treatment methods are     better.      This project will measure quality of life from the patient's perspective after treatment for     anal cancer. It will also gather preliminary data on quality of life after the introduction     of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called     IMRT.   "
109476|NCT01853046|"     To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe     renal impairment when compared to the Control group (cancer subjects with normal or mildly     impaired renal function)   "
109477|NCT01853033|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     ABT-122 in subjects with Rheumatoid Arthritis.   "
109478|NCT01853020|"     The purpose of this study is to characterize the dose-related effects of     delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor     functions.   "
109479|NCT01853007|"     The purpose of this study is to test the impact of a newly developed educational program on     kidney transplant candidates' communication about living and deceased donor kidney     transplantation.   "
109480|NCT01852994|"     The purpose of this study is to determine if exercise training with or without testosterone     replacement can improve cardiopathy in heart failure patients   "
109481|NCT01852981|"     To verify changes in physical activity levels, metabolic markers, and physical fitness as     results of two physical activity interventions within the Brazilian public health system     (primary health care).   "
109482|NCT01852968|"     The hippocampus is an area of brain which plays an essential role in learning and memory     processing and is thought to be particularly vulnerable to effects of hypoglycemia (low blood     glucose). The goal of this project is to examine hippocampal neurochemistry and metabolism     and identify how diabetes and recurrent hypoglycemia alter the hippocampus.   "
109924|NCT01847157|"     Background and purpose:      About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor     impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke     patients' daily living independence and quality of life. However, treatment effect of current     interventions is still limited. Nick Ward and Leonardo Cohen suggested 5 intervention     strategies for stroke motor recovery: （1） reduction of somatosensory input from the intact;     （2） increase in somatosensory input from the paretic; （3） anesthesia of a body part proximal     to the paretic hand; （4） activity within the affected motor cortex may be up-regulated; （5）     activity within the intact motor cortex may be down-regulated. Recent studies have shown each     strategy to be effective in stroke patients with mild or moderate UE impairment. However,     evidence for people with severe UE impairment after stroke remains unclear. Since research     has found a greater effect for combined strategies than a single strategy, this proposal     develops a combined intervention with the above 5 strategies, named transcranial direct     current stimulation （tDCS） combined sensory modulation intervention. This intervention is     expected to be most effective for people with severe UE impairment after stroke.      In addition, neuroimaging can provide in vivo information about the brain plasticity which     underpinning the motor recovery after stroke. However, image indexes that can be used in     stroke patients with severe UE impairment remained examined. Therefore, this proposal has 3     aims: （1） to examine the treatment effect of the tDCS combined sensory modulation     intervention in stroke patients with severe UE impairment; （2） to examine the underline     mechanism of the efficacy of tDCS combined sensory modulation intervention using     neuroimaging technology.      Methods:      This study is a double-blinded randomized controlled trial which will recruit 60 people who     have had stroke onset more than 6 months and have severe UE motor impairment. All     participants will be randomly assigned into 2 groups. The experimental group will be given     the tDCS combined sensory modulation intervention, combining bilateral tDCS stimulation,     anesthesia techniques and repetitive passive motor training. The control group is given sham     tDCS, sham anesthesia and repetitive passive motor training. Each group will be evaluated for     outcomes at 4 time points （i.e. baseline, post-intervention, 3 months and 6months     post-intervention）. The immediate and long-term effect of the interventions will be examined.      Primary outcome indicators include upper extremity impairment measures. Secondary outcome     measures include upper extremity function, activities of daily living function, functional     Magnetic Resonance Imaging （fMRI）, and corticospinal tract structural integrity using     diffusion spectrum imaging （DSI）. Fifteen subjects of each group will be assessed 2 times     （i.e., prior to the intervention and after the intervention） for fMRI and DSI scan.      Anticipatory results and contributions:      The results of the studies are expected to present a potentially effective intervention for     stroke patients with severe impaired UE motor. Imaging evidence of brain plasticity for this     particular intervention is also provided. The results will contribute to our understanding of     brain plasticity for UE motor recovery after stroke. Findings from this proposal may help     researchers and clinicians choose or develop interventions that are optimal to their clients     individually.   "
109483|NCT01852955|"     Recent evidence demonstrates that perioperative pain continues to be poorly managed among     ambulatory surgical patients. More importantly, few interventions that minimize postoperative     pain have also shown to improve patient overall quality of post-surgical recovery. Ketorolac     has been used to minimize perioperative pain despite the lack of evidence for its use when     administered as a single dose preventive strategy.Ketorolac has also been associated with a     higher incidence of perioperative hematomas and the need for surgical re-exploration after     breast surgery.      Systemic acetaminophen has become recently available in The United States. In contrast to     ketorolac, systemic acetaminophen has not been reported to have adverse side effects on     patients undergoing breast surgery. Although evidence suggests that a single dose     perioperative acetaminophen reduces postoperative pain, it remains unknown if a single dose     intravenous acetaminophen improves postoperative quality of recovery after ambulatory     surgery.      The main objective of the current investigation is to evaluate the effect of a single dose     systemic acetaminophen on postoperative quality of recovery after ambulatory breast surgery.     We also seek to determine if systemic acetaminophen would decrease postoperative pain and the     time to hospital discharge in the same population.      Significance: The current project evaluates a potential intervention to improve perioperative     pain and recovery after ambulatory breast surgery. Postoperative pain in the ambulatory     surgical patients has been shown consistently to be poorly managed.   "
109485|NCT01852929|"     The purpose of this study is to determine whether obstructive sleep apnea affects sleep     dependent memory and learning. Subjects with apnea will be given a test of perceptual skill     learning (the Visual Discrimination Task (VDT)) that has previously been shown to depend on     sleep. Subjects will be tested on this task before and after sleep. The difference in     performance after sleep compared to before sleep provides a measure of sleep dependent     learning. Participants will be tested on one night when they have less apnea because they are     using continuous positive airway pressure (CPAP) as prescribed by their physician, which is     well known to reduce apnea; and on another night when they are in their native state and have     a greater degree of apnea. Memory performance will be compared between the two nights to     determine how apnea affects sleep dependent memory.   "
109486|NCT01852916|"     The purpose of the study is to assess whether nasal high frequency ventilation (NHFV) is     superior to nasal continuous positive pressure (nCPAP) to prevent tracheal intubation and     mechanical ventilation in preterm infants less than 28 weeks gestation following first     attempt at extubation and removal from mechanical ventilation   "
109487|NCT01852903|"     The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour     period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and     placebo.   "
109488|NCT01852890|"     This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate     (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.   "
109489|NCT01852877|"     Aim-1: Evaluate opt-out versus opt-in testing for the human immunodeficiency virus (HIV) at     the Cook County jail and the Illinois Department of Corrections Northern Intake facilities.     Outcomes of interest include a) uptake of each HIV testing strategy, b) comparative     effectiveness of identifying HIV-positive cases, new cases and undisclosed cases, and c)     predictors of HIV testing.      Aim-2: Evaluate two case management strategies - correctional case management and     transitional case management - designed to improve linkage and adherence to appropriate     medical care after release from incarceration. Correctional case management is a longer-term,     more intense approach while transitional case management seeks to meet the clients' immediate     needs, link them to Ryan White case management, and then support the Ryan White case manager     in assisting these clients. Correctional case management will be compared to the standard of     care for jail detainees, and to transitional case management for persons leaving prison.     Outcomes of interest include, (a) HIV viral load and CD4 cell counts over time, (b) adherence     to medication, and (c) visits to medical providers.      Aim-3: Evaluate the impact of an incentive for HIV-positive detainees released from jail to     visit an HIV service organization where they can be linked to medical care and case     management. Outcomes of interest are essentially the same as Aim-2.      Aim-4: Assess university-based telemedicine as means to improve care of state prison inmates     living with HIV. Outcomes of interest include medication regimens, HIV viral load and CD4     cell counts, and associated health conditions.      Aim-5: Assess the uptake of partner notification and social network HIV counseling and     testing involving HIV-positive persons released from jail and prison as a means to extend the     reach of the 'seek, test, treat and retain' (STTR) model into the community.   "
109490|NCT01852864|"     The biological effects of castration on prostate cancers will be studies by administration of     degarelix prior to radical prostatectomy.      The effects will be studied by analysis of gene expression and immunohistochemistry focusing     on markers of proliferation and apoptosis of samples taken at the time of radical     prostatectomy (7 days after administration of degarelix).      Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from     patients who have not been medically castrated.   "
109491|NCT01852851|"     The investigators plan to conduct a randomized controlled trial to evaluate the effectiveness     and the cost effectiveness of an on-line eLearning program (entitled Employment and     Arthritis: Making it Work) designed to help people with inflammatory arthritis stay employed.     The program also includes assessments with 1) an occupational therapist, and 2) a vocational     rehabilitation counsellor at the end of the program to help participants identify and obtain     necessary changes at work. People from three provinces will be recruited from collaborators'     patient and program recipient lists. The study group will receive the program intervention     and the control group will receive usual care and printed educational material. All     participants will be followed for five years. The effectiveness of the program at improving     at work productivity and reducing work cessation will be evaluated compared to a control     group receiving printed material on employment and arthritis.   "
109500|NCT01852734|"     The purpose of this prospective non-randomised study is to examine whether two different     microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the     uterine fibroid controlled with contrast-enhanced MR examination.      Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement     characteristics before intervention and 3 months after interventions will be analysed as a     potential predictor of volumetric response after embolization.      Another purpose is to determine long-term follow-up in all patient treated in a period from     2001-2011 in OUH analysed retrospectively.   "
109501|NCT01852721|"     The purpose of this study is to document differences between men and women (referred here as     gender differences) in diet adherence and in changes in specific dietary intakes and energy     density in response to a 12-week nutritional education program promoting the Mediterranean     diet in both the short term (immediately after the end of the intervention) and longer term     (3 and 6 months after the end of the intervention). The investigators hypothesize that both     in the short and the longer term, women will have a better adherence to recommendations     promoting the Mediterranean diet than men namely because of higher self-determination.   "
109492|NCT01852838|"     Lung cancer is the most lethal cancer, killing ~1.3 million people worldwide every year.     Early diagnosis could increase its survival by 3-4 folds. Therefore the yield of screening     for lung cancer is not a question anymore and the urgent unmet need is to define the group     that is under a high risk for lung cancer.      Our lab is focusing on revealing non-invasive biomarkers as for early detection of lung     cancer. This study specifically focuses on biomarkers that are found in exhaled breath. These     biomarkers are known as volatile organic compounds (VOCs).The VOCs' profile can discriminate     between those who suffer from lung cancer and healthy individuals.      It is well established that a cancer cell can activate their glycolysis (glucose degradation)     pathway in order to survive. This links malignant processes with this basic biochemical,     metabolic cycle. This study will focus on the unique processes incurred by glycolysis in the     tumor cells and its effect on the surrounding environment. By better understanding and     revealing the exact mechanism, it will become possible to identify the biomarkers released by     malignant cells that use glycolysis as a source of energy.      This study's goal is to identify and analyze those distinguishing VOCs. The hope is that     these VOCs will provide a new innovative possibility of developing the so desperately needed,     early-detection lung cancer screening method.      This research will collect and analyze the exhaled breath of participants. The exhaled breath     will be obtained before and after a glucose challenge test, in which the participant is asked     to drink a solution containing water and glucose. This study will involve a total of seventy     participants, fifty of which currently suffer from active lung cancer, while the remaining     participants belong to a high-risk group.   "
109493|NCT01852825|"     The purpose of this study is to assess the effect on various biomarkers of treatment with     MK-8237 in participants with allergic rhinitis or rhinoconjunctivitis. In Part 1 of the study     healthy participants undergo nasal allergen challenge (NAC) with house dust mite (HDM)     extract in order to verify the operational performance of NAC and associated sample     collection methods. Part 2, the main study, is a placebo controlled, double blind study of     participants with HDM-induced allergic rhinitis or rhinoconjunctivitis. The primary     hypotheses are that the changes from baseline in post-allergen challenge HDM-specific     Immunoglobulin G4 (IgG4) and Immunoglobulin E blocking factor (IgE-BF) are greater after     treatment with MK-8237 than after treatment with placebo.   "
109538|NCT01852461|"     Perfusion index may vary according to type of surfactant during the treatment of respiratory     distress syndrome.   "
109495|NCT01852799|"     This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma.      The primary objectives of this study is to assess the effect of bortezomib combination     therapy (PAD regimen) followed by ASCT on bone metabolites in patients with newly diagnosed     multiple myeloma, as measured by ELISA methodology as previously described analyzing the     change in biochemical bone marker compared with the baseline value: bone formation marker-     bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）.      The secondary objectives of this study are:        1. Subgroup analysis for the change from baseline in biochemical bone marker based on          whether or not Bisphosphonate was used.        2. Assessment of other bone markers parameters: bone formation marker -carboxy terminal          propeptide of type I procollagen (PICP); bone resorption markers -carboxy terminal          telopeptide region of type I collagen ( ICTP); osteoclast stimulators          -osteoprotegerin(OPG), soluble receptor activator of nuclear factor kappaB          ligand(sRANKL);        3. To observe the effect of bortezomib on bone mineral density (BMD) as measured by          repeated quantitative CT-scan;        4. The evaluation of Skeletal related events (SRE) and appearance of new bone lesions;        5. To determine progression free survival (PFS), 1 year survival, overall survival and          safety profile following treatment with PAD and ASCT as first-line therapy.   "
109496|NCT01852786|"     The aim- To evaluate the impact of combined oral contraceptives on women's psychosexual,     metabolic, blood coagulation, hormonal and genetic measures.      Combined oral contraceptives (COCs) is still the most popular contraception method. It is     possible to find a number of publications about their non-contraceptive benefits, also about     their adverse events. Most researches are conducted during clinical trials, which are     commissioned by pharmaceutical companies, in order to compare COCs of different composition.     This study set out to assess the role of psychosexual, metabolic, endocrine, hormonal and     genetic measures of low dose combined oral contraceptive users- 20 micrograms of     Ethinylestradiol/3 mg of Drospirenone and 20 micrograms of Ethinylestradiol/75 micrograms of     Gestoden. Because this study is not commercial, it is expected to obtain valuable objective     data - there are very few comparative studies about the impact of COCs to woman's organism.   "
109497|NCT01852773|"     This study aims to increase understanding of the short-term and long-term outcome of blunt     aortic injury (BAI) and to discern if there is an advantage resulting from the type of     operative treatment used to manage it, either the classic open surgical repair or a newer     technique known as thoracic endovascular repair (TEVAR). Specifically, this study will answer     the following questions regarding patients suffering BAI:        1. What clinical variables affect short-term mortality and neurologic outcome?        2. What are the long-term treatment-associated complications of open repair and TEVAR?        3. In patients with a similar injury and physiologic profile, is there a survival advantage          resulting from the type of operative treatment?   "
109498|NCT01852760|"     In this cross-sectional study patients with active or quiescent ulcerative colitis will be     studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood     flow and thickness as reliable indices of disease severity and the degree of correlation that     exists with validated clinical, endoscopic, and histological indices.   "
109499|NCT01852747|"     This study is being done to compare people who had a standard of care spinal fusion using     part of their local bone graft (a small amount of bone from the region of the spine where the     fusion is occurring) to correct an adult spinal deformity and people who will have a standard     of care spinal fusion using a mixture of Actifuse ABX® (a market approved bone graft     substitute) and a local bone graft (a small amount of bone from the region of the spine where     the fusion is occurring). This study will compare the outcomes of both groups to help the     Orthopaedic surgeon conducting spinal fusions in the future. Investigators expect that     Actifuse ABX® will be as good if not better than just a local bone graft.   "
112716|NCT01810575|"     The purpose of this study is to assess the safety & efficacy of a single dose of alprostadil     cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile     dysfunction.   "
109503|NCT01852695|"     In the highly technological environment of the modern neonatal intensive care unit (NICU),     the infant is physically, psychologically and emotionally separated from its parents.     Recognition that this impedes parent- infant interaction and is detrimental to the infant,     led to the development of programs such as family centered care, kangaroo care and     skin-to-skin care1-3. However, they are based on the common premise that only NICU     professionals with special skills can provide care for the infant. Parents are relegated to a     supportive role, and some have described themselves as voyeurs who are allowed to visit and     hold their infants4. Many feel anxious and unprepared to care for their infants after     discharge5.      In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a humane care     model in which parents provided nursing care for the infant (except for administration of IV     fluid and medication), while nurses provided teaching and guidance to parents. This resulted     in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length     of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents     and staff [personal communication, Levin,A.]. Building on the Estonian experience, we have     developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment     in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their     families were enrolled in the study. Preliminary results and feedback from parents and     healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to     improved outcomes including improved weight gain(paper submitted for publication). This study     is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy     of the FIC model in Canada.   "
109505|NCT01851928|"     The objective of this study is to evaluate the sensitivity and specificity of two nutrition     screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two     tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the     Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted     gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools     are in the form of scored questionnaires and are suitable for electronic input.      The ultimate objective is to select an adult inpatient nutrition screening tool with the     highest sensitivity for future use in the oncology inpatient setting in order to allow prompt     commencement of an appropriate nutrition care plan.   "
109506|NCT01851915|"     In this study, the differential effectiveness of CBT and IPT for patients with Major     Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both     methods are evidence based and recommended by the National Board of Health in Sweden. They     are manual based and the patients will receive 14 sessions in each therapy. Their comparative     effectiveness has not been studied in Sweden, and their effectiveness with regard to work     capacity has not been tested. The hypotheses in the study are that they have equal effect for     depression remission, but that CBT is superior when return to work is measured. Three     moderator analyses, testing effects for different subgroups, will be made. They propose that     patients with attachment avoidance and lower mentalization ability and male patients will     have better outcome with CBT. The study will be performed at Sundsvall Hospital, in     cooperation with Linköping University. Sundsvall hospital is the only hospital in Sweden     where there is a group IPT therapists large enough to make a controlled study possible. The     study has a randomized design, with 16 therapists, 8 of them delivering CBT and 8 IPT. The     number of patients is 96. The statistical power is .87, with a hypothesized between-groups     effect size of d = .40 for return to work, and the significance level of .05 for the     between-groups difference. Outcome will be measured as remission of psychiatric diagnosis,     decrease in depression severity and frequency of patients who return to work. Both     intent-to-treat and completers analyses will be made. The project will go over two years. The     study has an effectiveness character in the sense that treatments, although manual based,     will be performed in the manner that the therapists usually work, and by having broad     inclusion criteria. Treatment integrity will be ascertained by therapist reports and by     filming sessions.   "
109507|NCT01851902|"     The purpose of this study is to determine, through continuous monitoring with a cardiac     monitoring device placed under the skin, the incidence of atrial fibrillation or flutter     (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It     is hoped that this information may assist health care professionals in treatment decisions     related to the early identification of patients at high risk for AF.   "
109508|NCT01851889|"     The purpose of the trial is to identify factors which can be used as guidance when optimizing     continuous-flow left ventricular assist device (CF-LVAD) settings.      The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change     independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed     ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.      The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under     ramp testing in a cohort of continuous-flow left ventricular assist device heart failure     patients.   "
109509|NCT01851876|"     Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing     long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.   "
109510|NCT01851863|"     The study hypothesis is appropriate clinician-patient communication that provides     explanations of the reasons for psychoactive drug prescriptions based on the generation of FD     symptoms and the drugs' effects might improve compliance with psychoactive agent regimens     among FD patients.   "
109511|NCT01851850|"     The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by     subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for     additional three years.   "
109512|NCT01851837|"     The exercise time is an important factor among the medical guides for weight loss; however,     there is still little knowledge about exercise duration paths in middle-aged and older women.     The present study aimed to determine the effects of the interval training on weight loss and     lipid profile, and to compare its efficiency with the continuous training.   "
109513|NCT01851824|"     This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of     multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in     participants with BRAFV600 mutation-positive metastatic malignancies. Participants will     receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg     orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26,     eligible participants will have the option to continue treatment with vemurafenib as part of     an extension study (GO28399 [NCT01739764]).   "
109514|NCT01851811|"     Despite widespread agreement that continuous positive airway pressure is effective therapy     for obstructive sleep apnea, it is estimated that 50% of patients recommended for therapy are     noncompliant 1 year later. Nasal continuous positive airway pressure (CPAP) is the most     definitive medical therapy for obstructive sleep apnea (OSA). Many patients have difficulty     tolerating nasal CPAP due to nasal airway problems, mouth leak, and general discomfort from     the mask and headgear. Interventions to improve compliance in such patients have not been     studied. The investigators plan to further evaluate the usage of CPAP and identify if the     timing of last meal before bedtime affects the compliance and tolerance of CPAP.   "
109934|NCT01847027|"     The purpose of this study is to see if an investigational supplement called NutraStem® will     increase the amount of stem cells in human blood at rest and after exercise. The ingredients     found in NutraStem® can be found in nutrition or vitamin shops/stores.   "
109515|NCT01851798|"     Obstructive sleep apnea (OSA) is a relatively common medical condition that includes     upper-airway obstruction and consequent cessation of breathing during sleep with significant     associated other medical problems. The time period around surgery has been demonstrated to be     an independent risk factor for various complications but the mechanism is not well     understood.      This protocol proposes to study the fundamental question of what changes occur in the     postoperative setting to ambulatory patients with and without OSA by administering a     validated STOP-BANG screening questionnaire and conducting preoperative and postoperative     Home Sleep Testing (HST). In doing so, critical evidence shall be gained in the understanding     of postoperative sleep disorder breathing changes associated with surgery and anesthesia.     With evidence, sound perioperative management recommendations and policy may be developed to     assist with caring for this large and at risk surgical population.   "
109539|NCT01852448|"     Cystic fibrosis related diabetes (CFRD) is associated with worse CF-relevant outcomes.      The mechanisms underlying CFRD development are not fully understood, but recent evidence     suggests Type 2 Diabetes Mellitus (T2DM) mechanisms may be involved and may involve incretins     (gut secreted hormones that augment insulin secretion in response to a nutrient load).      This study will examine the prevalence of Genome wide association study (GWAS)-implicated     T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in CF and will     use this information to compare incretin and insulin secretion in non-diabetic children and     adults with high risk and low risk alleles.   "
109516|NCT01851785|"     A randomized, controlled design will be utilized to examine and compare the effectiveness of     the proposed educational intervention, which includes an educational decision aid with     attention control on select key patient-centered and process of care outcomes. The study     sample will consist of approximately 300 African-American patients with osteoarthritis (OA)     of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center and the     Philadelphia VA Medical Center and will be randomized to one of the two study arms.      The immediate goal of this randomized controlled trial is to assess the effect of a     high-quality, evidence-based, patient-centered educational intervention on African American     patient preferences, expectations, and the likelihood of receiving a recommendation for knee     joint replacement surgery when clinically indicated. The long-term goal of this research is     to implement effective strategies to improve minority patients' access to joint replacement     and ultimately eliminate racial disparities in the utilization of this effective treatment     for knee OA.      Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of     receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis:     The DA intervention will lead to higher rate of treatment recommendation within 6 months.      Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement     receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will     undergo knee replacement within 12 months at a higher rate than those in the attention     control group.   "
109517|NCT01851772|"     The purpose of this study is to evaluate the safety, performance and usability of the Xoft     Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the     physician's current standard treatment practice and in replacement of high-dose-rate     after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on     treatment delivery, safety, and acute toxicity.      Our hypothesis is that the treatment is safe as incorporated into the physician's current     standard of practice.   "
109518|NCT01851759|"     Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of     methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral     infarction patients, and explore the best safe and effective dose as well as dose method.   "
109519|NCT01851746|"     The purpose of this study is to evaluate the effectiveness and security of lobaplatin     combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.   "
109520|NCT01851733|"     This pilot clinical trial studies magnetic resonance imaging (MRI)-guided laser surgery (MLA)     and doxorubicin hydrochloride in treating patients with recurrent glioblastoma multiforme.     The blood brain barrier (BBB) is a separation of circulating blood from the tissue of the     central nervous system, preventing substances in the blood from entering the brain. MLA     disrupts the BBB around the tumor which may allow cancer-killing substances to be carried     directly to the tumor and the surrounding area. Using MLA prior to chemotherapy may result in     a greater concentration of drug in the tumor to kill the cancer cells while limiting side     effects.   "
109521|NCT01852682|"     The purpose of this study is to investigate efficacy and safety, when administering PA21, in     peritoneal dialysis patients having hyperphosphatemia.   "
109522|NCT01852669|"     This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL)     with and without simultaneous adjunct controlled inversion therapy in the treatment of lower     pole caliceal stone.   "
109523|NCT01852656|"     Influenza disease causes significant morbidity and mortality in the Unites States each year.     Although influenza can cause morbidity in otherwise healthy individuals, adults with chronic     lung disease have significantly increased rates of hospitalization from influenza-related     illnesses compared to healthy adults. Influenza vaccination is the primary means of     preventing influenza disease. Annual influenza vaccination is recommended for all individuals     6 months of age and older in the United States. Influenza vaccination rates are sub-optimal,     however. Patient reminder/recall has been shown, in multiple studies across a variety of age     groups and health conditions, to increase immunization rates. However, the effectiveness and     cost-effectiveness of different types of reminder/recall has not been well-studied,     particularly in adults. In the fall of 2012, the Population and Prevention Services (PPS)     Department at Kaiser Permanente Colorado (KPCO) is using 3 different reminder strategies for     influenza vaccination among adults with asthma and chronic obstructive pulmonary disease     (COPD). The objective of this study is to provide a rigorous evaluation of which strategy is     more effective and more cost-effective, to promote influenza vaccination.   "
109524|NCT01852643|"     Most of the studies performed to compare the present techniques of rhinoplasty have been     based on the clinical examination and change of postoperative complaints that cannot be very     precise in evaluating the advantages of one technique over another. Therefore, in this study     the investigators are going to compare the efficacy of spreader graft and lateral crural     overlay techniques by an objective method, rhinomanometry.   "
109525|NCT01852630|"     1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver          & Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial          Peritonitis) by ascitic fluid examination at admission.        2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute          neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients          with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to          receive cefepime or imipenem.        3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for          randomization will be given empirical therapy with 3rd generation cephalosporin          (ceftriaxone).   "
109540|NCT01852435|"     The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70     Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma     Grade 3B patients.   "
109612|NCT01851252|"     The purpose of this study is to determine the effect on the (carbon 13     labelled(13C)-Methacetin Breath Test (MBT) of i.v. propranolol, a non-selective beta blocker     (NSBB) following initial administration and after chronic use of each of these agents. The     correlation of the MBT with Hepatic Venous Pressure Gradient (HVPG) measurement before and     after treatment will be assessed. Additionally, the MBT measurements following 60 days of     therapy will be compared to the first MBT measurement and to the second MBT measurement, post     HVPG. Each patient's subsequent MBT measurement will be compared to his previous MBT results     in order to determine his/her response to therapy.   "
109526|NCT01852617|"     Argentina and Uruguay are among the countries with the highest proportion of pregnant women     who smoke. The implementation of an effective smoking cessation intervention would have a     significant impact on the health of mothers and children. The 5 A's (Ask, Advise, Assess,     Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15     minutes delivered by a trained provider, which is considered the standard of care worldwide.     However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel     cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics     in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in     prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving     tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the     intervention will decrease the frequency of women who smoke by the end of their pregnancies.     Prenatal clinics will be randomly allocated to either an intervention or a control group     after a baseline data collection period. Midwife facilitators in the ten intervention clinics     will be identified and trained to deliver the 5 A's to pregnant women and will then     disseminate and implement the program. The ten clinics in the control group will continue     with their standard in-service activities. A follow-up data collection will be conducted     immediately after delivery. The intervention will be tailored by formative research to be     readily applicable to local prenatal care services at busy maternity hospitals, as well as to     be acceptable to local pregnant women and health providers. The study will be conducted in 48     months.   "
109527|NCT01852604|"     Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and     pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with     ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus     (HCV)-infected participants.      Part C of this study is designed to evaluate the safety, tolerability, efficacy and     pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when     administered in combination with or without RBV for 12 weeks in treatment-naïve or     interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.   "
109528|NCT01852591|"     There is no study hypothesis. The purpose of this study is to see if the Pneumococcal     conjugate vaccine (PCV13), when administered before and early after an autologous peripheral     stem cell transplant will induce an immune response.   "
109529|NCT01852578|"     The investigators propose to study the single agent activity of Cabazitaxel in a Phase II     trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with     docetaxel, given the fact of its significant activity and its acceptable toxicity profile.   "
109530|NCT01852565|"     Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein     associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline     as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV)     events in patient populations with chronic coronary heart disease and after an acute coronary     syndrome.      This study will determine the effect of repeated administration of diltiazem on the     pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a     moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.   "
109531|NCT01852552|"     Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing     transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve     replacement (AVR).      The objectives of the study are:        1. Description of neurocognitive status before and after transcatheter aortic valve          implantation and aortic valve replacement procedures        2. Description of Quality of Life (QoL) after these procedures        3. Defining the relevance of baseline psychological, emotional and cognitive factors on the          outcomes associated to the different treatment modalities        4. Assessment of costs associated to each of the above mentioned strategies of treatment,          including costs of the index hospitalization and costs of follow-up.   "
109532|NCT01852539|"     The investigators attempted to determine the optimal dose of dexmedetomidine required for the     successful insertion of LMA during propofol induction without a neuromuscular blocking agent.   "
109627|NCT01851057|"     Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs     (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated     with continued seizures, mortality, poor quality of life, and high healthcare costs. There     are no adherence interventions for young children with epilepsy and their families; thus, the     current proposal examines a family-based behavioral treatment focused on improving epilepsy     knowledge and problem-solving around barriers to adherence in young children with epilepsy     and their families with the goal of improving adherence and ultimately, seizures and quality     of life. It is hypothesized that children with newly diagnosed epilepsy and their families     who participate in the problem-solving intervention will have significant improvements on     adherence compared to those in the education only intervention.   "
109533|NCT01852526|"     This study is designed as a randomized, parallel-group, therapy-controlled trial in a     clinical care setting at a university hospital. Patients presenting to our outpatient clinic     with degenerative disc disease or spondylolisthesis will be assessed against study inclusion     and exclusion criteria. After informed consent and randomization of patients, surgery will be     performed. Follow-up examinations will take place immediately after treatment during hospital     stay, and then after another 6 and 24 weeks, for a total study duration of 6 months. Data     will be assessed after 12, 24 and 36 months for a supplemental investigation. A further     assessment will be performed every year, owing to the possibility that a statement regarding     ASD cannot be given after 36 months.      Experimental research in this trial will be performed with the approval of the ethics     committee of the medical faculty of the University of Cologne and of the university of Halle.   "
109534|NCT01852513|"     The investigators hypothesize that treatment with QNASL will reduce nasal mucosal     inflammation induced by the allergy season and prevent the changes in the microbiome caused     by the allergy season.   "
109535|NCT01852500|"     Results from previous studies suggest the association between Osteopathic Manipulative     Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.      The primary objective of the present study is to evaluate the effectiveness of sham OMT in     reducing LOS in a sample of preterm newborns, in order to investigate whether previous     clinical results could be related to a hypothetical placebo effect.   "
109536|NCT01852487|"     Androgenic alopecia is the most common cause of hair loss in men. Finasteride and minoxidil     are available in treatment of androgenetic alopecia, although the former causes decreased     libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the     scalp. Recently, Pulpkin Seed Oil shows some improved clinical efficacy on scalp hair growth     in men with androgenetic alopecia, but there is no evidence to support this.      The investigators conducted a randomized, double-blind, placebo-controlled efficacy and     tolerability trial of Pumpkin seed oil (400mg/day)therapy in male patients with androgenetic     alopecia.   "
109581|NCT01851668|"     This is an observational pilot study to quantify the amount of vibration, noise,     physiological and biochemical instability that premature babies are exposed to during     inter-hospital transport.   "
109541|NCT01852422|"     Pelvic organ prolapse is a common disorder that results in significant patient morbidity.     Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP)     and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP     remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani     (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during     childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures     employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse     surgery, there is a paucity of information regarding the identification of these structures     outside of surgical dissection. Furthermore, there is no published data describing the     relative distances between the apex of the vagina and these ligaments in women with prolapse.     Recent developments in imaging have enabled the identification of the distal subdivisions of     the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the     subdivisions of the pubovisceralis. The visualization of these structures is possible using a     3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and     in live humans, with excellent interrater reliability. The investigators propose to use this     technology to explore the anatomy of the sacrospinous ligaments.   "
109542|NCT01852409|"     Malignant ascites often has a profound impact on the quality of life of cancer patients.     Current treatments,including dietary, medical, and procedural are often temporary and     unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab     for the palliation of malignant ascites might be a novel choice for refractory malignant     ascites.   "
109543|NCT01852396|"     The goal of this study is to demonstrate that the novel retroclavicular approach is a safe,     fast and effective technique for ultrasound-guided brachial plexus anesthesia.   "
109544|NCT01852383|"     Dysthymic disorder (DD) denotes chronic depression with fewer symptoms than major depressive     disorder (MDD), and it affects ~ 2-4 % of adults with a similar prevalence in the elderly. In     the elderly, dysthymic disorder (DD) has been shown to be associated with suffering and     disability. The differences between young adult and elderly DD patients indicate that     findings obtained in young adults with DD cannot be extrapolated to elderly DD patients who     need to be studied separately. Data from epidemiologic studies support this view. In contrast     to the data in young adult DD patients, there is a paucity of controlled data on the     treatment of elderly DD patients. In our center, a double-masked, placebo-controlled study of     91 elderly DD patients did not find significant superiority for fluoxetine over placebo with     response rates of 27.3% for fluoxetine and 19.6% for placebo in intent-to-treat analyses, and     response rates of 37.5% for fluoxetine and 23.1% for placebo in completer analyses. Given the     relative failure of selective serotonin reuptake inhibitor (SSRIs) to treat geriatric DD     effectively, the investigators decided to evaluate the dual reuptake inhibitor, venlafaxine.      The investigators earlier completed an investigator-initiated, open-label 12-week venlafaxine     (Effexor XR) trial. Of 23 elderly DD patients, 18 completed the trial. Fourteen (60.9%) were     responders in intent-to-treat analyses with the last observation carried forward, and 77.8%     were responders in completer analyses. Nearly half the sample (47.8%) met criteria for     remission. In the intent-to-treat sample, increased severity of depression at baseline was     associated with superior response and the presence of cardiovascular disease was associated     with poorer response. These results with venlafaxine indicate that further treatment studies     of dual serotonin-norepinephrine reuptake inhibitors like duloxetine are warranted in elderly     patients with dysthymic disorder.   "
109545|NCT01852370|"     The purpose of this study is to determine whether bilateral orthotopic lung transplantation     (BOLT) followed by cadaveric partially-matched hematopoietic stem cell transplantation (HSCT)     is safe and effective for patients aged 5-40 years with primary immunodeficiency (PID) and     end-stage lung disease.   "
109554|NCT01852253|"     Peri-implantitis is a infectious disease that resides in the mucosa surrounding dental     implants and also affects the supporting bone. Because the number of implants placed in     everyday clinical practice is continuously increasing, is it reasonable to anticipate an     increasing prevalence of peri-implantitis. This underlines the necessity for a predictable     therapy. However, from the literature there is very little reliable evidence suggesting which     could be the most effective interventions for treating periimplantitis.      The primary objective of this controlled clinical study is to evaluate the clinical effect of     decontamination of the implant surface during the surgical treatment of peri-implantitis     using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective     is to assess the microbiological effect of decontamination of the implant surface during the     surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12%     chlorhexidine solution.      The primary study parameter is the change from baseline in modified bleeding index. Secondary     study parameters are: change in microbial composition of the biofilm covering the dental     implant surface; microbiological composition of the peri-implant sulcus; change in probing     pocket depth;change in suppuration on probing; change in radiographic marginal bone level on     standardized intraoral radiographs; change in modified plaque index; implant failure, defined     as implant mobility of previously clinically osseointegrated implants and removal of     non-mobile implants because of progressive marginal bone loss or infection; complications and     adverse events. It is hypothesized that decontamination of the implant surface with 2%     chlorhexidine leads to a greater decrease in modified bleeding index than decontamination     with a 0.12% chlorhexidine solution.   "
109546|NCT01852357|"     The primary objective of this study is to evaluate the effectiveness of neurofeedback     training (NFB) on objective measurements of attention in young adults with ADHD. The     secondary objectives are to evaluate neurofeedback effects on self-report measures of     attention, ADHD symptoms, and to identify electroencephalogram (EEG) markers of ADHD and     neurofeedback efficacy. The study is a double-blind, placebo controlled clinical trial to     test the efficacy and safety of EEG neurofeedback in individuals 18-40 years of age with     attention deficit hyperactivity disorder (ADHD). Attention will be evaluated at baseline,     after 12 and 24 training sessions (an average of 4 and 8 weeks, respectively), and 4 weeks     after the last neurofeedback session. The primary outcome will be change from baseline on the     Attention Performance Index (API) variable of the Test of Variables of Attention (TOVA) a     standardized, well-normed, computerized test of attention, after 12 neurofeedback or sham     training sessions (and average of 4 weeks). Secondary outcomes will be change from baseline     on other TOVA variables after 12 and 24 sessions (an average of 4 and 8 weeks, respectively),     at 4 weeks post-training follow-up, and changes from baseline at each time point on the Adult     Self Report Scale (ASRS) and Mindful Awareness and Attention Scale (MAAS). EEG data collected     during TOVA attention testing at baseline will be used to model EEG differences between ADHD     and non-ADHD participants. Additional EEG data collected during the TOVA at midpoint (average     of 4 weeks), after 24 NFB sessions (average of 8 weeks), and 4 weeks post-NFB will be used to     develop statistical models to use as indicators of neurofeedback efficacy   "
109547|NCT01852344|"     Effortful control refers to the mental processes that help a person to regulate his or her     own attention, thoughts, and emotions. This study will examine behavioral differences in     healthy individuals when performing a task that induces fatigue.      The purpose of this study is to examine the effects of methylphenidate on the cognitive     functions in healthy individuals when performing fatiguing cognitive tasks.   "
109548|NCT01852331|"     The investigators hypothesize that Peony-Glycyrrhiza Decoction (PGD) adjunctive therapy could     reduce the incidence of prolactin (PRL)-related adverse events in patients with schizophrenia     and suppress antipsychotic-induced elevation of PRL levels.      This is a placebo-controlled trial conducted in schizophrenic patients to determine whether     PGD adjunctive treatment could produce greater biochemical and clinical improvement on     hyperprolactinemia (hyperPRL) compared to placebo treatment.   "
109582|NCT01851655|"     This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled patients     had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced     rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or     high-intensity plyometric exercise. The objective of the study was to determine the effect of     plyometric exercise intensity on knee function and knee cartilage in patients with ACL     reconstruction.   "
109583|NCT01851642|"     The purpose of this study is to look at how Alpha-1-antitrypsin (AAT) deficiency and Cystic     Fibrosis (CF) affect white blood cells in the lungs, called macrophages, and their ability to     work.   "
112694|NCT01810861|"     The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae     that causes invasive diseases at children and adults in Turkey.   "
109549|NCT01852318|"     Pruritus s a very distressing problem affecting patients with uremia and the prevalence of     uremic pruritus (UP) ranges between 22% to 66%. Although some studies suggested pruritus is     being decreased recently by use of better dialysis techniques, accumulating studies have     shown the still high prevalence of UP. Because of its long duration, frequency and high     intensity, UP has been reported to have a negative impact upon the patients' quality of life     (QoL). However, the therapies in use, including antihistamines, ultraviolets, opioid     antagonists and topical agents, are generally of insufficient efficacy, failing to provide     adequate and long-lasting relief. Based on the neuropathic hypothesis and frequent     co-occurrence of chronic pruritus and peripheral neuropathy in the patients undergoing     hemodialysis, gabapentin, a medication widely used for a spectrum of neuropathic pain     syndromes, has recently been suggested to be effective in the treatment of UP.Pregabalin,     another gabaergic drug structurally related to gabapentin, have an advantage over gabapentin     in terms of its more rapid response to stressful symptoms. Only two very recently     small-scaled studies evaluate the effect of pregabalin for UP. However, both these studies     were not randomized, placebo-controlled trails.As UP is still one of the most vexing and     disabling symptoms in patients with ESRD, we decided to do this multicenter, randomized     double-blind placebo-controlled trial (RCT) with a larger sample size and a longer duration.   "
109550|NCT01852305|"     Purpose:      The purpose of this study is to develop a novel pathway to decrease the cost and waiting time     to manage bariatric surgical patients with obstructive sleep apnea.      Hypotheses:      Compared to the current perioperative pathway, the proposed novel pathway incorporating     overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective     for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.      To decrease the cost and waiting time, we proposed a novel perioperative pathway to manage     obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be     screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two     groups:      The STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups        -  sleep study group (group 1) or        -  oximetry group (group 2).   "
109551|NCT01852292|"     Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo     plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a     platinum therapy.   "
109552|NCT01852279|"     This study will assess whether functional recovery of the hand muscles in patients with     spinal cord injury is enhanced when electrical stimulation of the muscles is delivered     actively by means of using the electroencephalography wave patterns arising from the patient     imagining moving their hand to operate the stimulator. A control group will obtain the     electrical stimulation treatment passively by a therapist operating the machine.   "
109553|NCT01852266|"     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants     and children. This study will evaluate the safety and immune response to an RSV vaccine in     healthy RSV-naïve children.   "
109628|NCT01851044|"     The purpose of this study is to compare the effects of platelet rich plasma, whole blood and     saline vehicle on the natural course of lateral epicondylitis.   "
109555|NCT01852240|"     Background Increased levels of C reactive protein (CRP) can be found not only within     individuals with periodontal diseases and those with atherosclerotic alterations but also     have been proved in men with erectile dysfunction (ED). NO seems to be the key mediator in     the endothelial-derived vasodilation and penile erection.      The incidence of ED increases in patients with diabetes, hypertonia, hypercholesteremia,     cardiovascular diseases and renal failure. First evidence suggests that there is a     relationship between periodontal disease and ED as well. Due to slow progression of chronic     periodontal disease (0.3-0.5mm attachment loss/year) it can be assumed, that periodontal     disease exists mainly before ED develops.      Specific Aims This cross-sectional study aims to assess the incidence of periodontal disease     in male individuals with ED. A possible correlation between severity of periodontal disease,     level of systemic hs-CRP and ED will be assessed. Additionally, further risk factors for     endothelial dysfunction, such lipid values, will be determined and regarded in the analysis.      Hypothesis The investigators assume, that severity of ED correlates with severity of     periodontal disease as well as with systemic involvement assessed by CRP-levels. In detail,     the investigators hypothesize, that severity of ED (assessed by the questionnaire     International Index of Erectile Function) correlates with the mean probing depth and the     level of systemic hs-CRP.      Material and Methods        1. st appointment: In the present cross-sectional study 100 male patients with ED will be          included. Patients who visit the urological department (Rudolfstiftung) for ED-treatment          will be asked to participate. The erectile dysfunction will be assessed by means of a          questionnaire (International Index of Erectile Function - IIEF-5). Urologic examination.          The following blood parameters will be assessed: testosterone, prolactin, hs-CRP, tumor          necrosis factor (TNF)-alpha, Interleukin-1, total cholesterol, LDL, HDL, HbA1c and          fasting glucose.        2. nd appointment: At the department of Oral Surgery (Bernhard Gottlieb School of          Dentistry) the periodontal situation and the index of decayed-missing-filled permanent          teeth (DMFT) index of the patients will be determined. A panoramic radiograph for          assessment of alveolar bone loss and a periodontal status (probing depth, recession,          bleeding- and plaque-indices) will be performed. The observer at the dental clinic will          have no information on the severity of the ED (observer blinded).   "
109556|NCT01852227|"     In collaboration with the Neurointerventional programs at state university of new york     Buffalo, state university of new york Stonybrook, Swedish Medical Center, Erlanger Health     System, Vanderbilt University, and West Virginia University School of Medicine, the     investigators aim to prospectively collect experiences where direct aspiration as a first     pass technique is used for thrombectomy procedures.      The investigators also want to compare specific characteristics from these cases to other     stroke cases where traditional thrombectomy devices were used.   "
109557|NCT01852214|"     Patients with diabetes mellitus (DM) have an increased risk of adverse atherothrombotic     events. This may be in part attributed to the fact that these patients have reduced response     to oral antiplatelet medications, in particular the P2Y12 receptor inhibitor clopidogrel,     used for secondary prevention of ischemic events. Prasugrel and ticagrelor are recently     approved P2Y12 receptor inhibitors which, compared with clopidogrel, have more potent     antiplatelet effects. Head-to-head comparisons between the two drugs are lacking.   "
109558|NCT01852201|"     Primary Endpoint:      The primary objective is to show that AIS patients, ineligible for or refractory to treatment     with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within     6-12 hours of symptom onset have less stroke related disability and improved good functional     outcomes as compared to those treated with best MT with respect to endpoint defined as:      • 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw     mRS scores. Statistical details can be found in section 7.2.      Secondary Endpoints:        -  90-day global disability in the 6-12 hr cohort assessed via the overall distribution of          mRS        -  Proportion of patients with good functional recovery for the 6-12 hr cohort as defined          by mRS 0-2 at 90 days        -  Mortality at 30 and 90 days        -  Intracranial hemorrhage with neurological deterioration (NIHSS worsening >4) within 24          hours of randomization        -  Procedure related serious adverse events (SAE's)        -  Arterial revascularization measured by TICI 2b or 3 following device use   "
109559|NCT01852188|"     The purpose of this study is to determine whether the use of sterile or clean gloves during     labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the     membranes around the baby.   "
109560|NCT01852175|"     Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and     ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent     antiplatelet effects compared with clopidogrel and are associated with an improved net     clinical benefit. However, to date there are limited head-to-head comparisons of these two     new agents.   "
109561|NCT01852162|"     Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of     treatment for prevention of atherothrombotic events in patients with coronary artery disease     (CAD) undergoing percutaneous coronary interventions (PCI). Many patients on dual     antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in     particular atrial fibrillation, therefore having an indication to also receive oral     anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under     triple therapy which consists of aspirin plus clopidogrel plus an oral anticoagulant. The     ever raising population with CAD warranting triple therapy and the growing number of patients     being treated with dabigatran underscores the importance of understanding the pharmacodynamic     effects of this treatment regimen.   "
109562|NCT01852149|"     The purpose of this study is to assess the safety and feasibility of the Mitralign     Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral     regurgitation. No formal test of hypothesis is proposed for this trial.   "
109563|NCT01852136|"     This prospective, multi-center, 2 period cross-over study is designed to determine if people     who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle     (PN) in comparison with currently marketed pen needles of the same or similar gauge and     length. Subjects will use the investigational (BD NEXT) PN and their usual conventional PN     each for one week in a randomly assigned sequence, and will be asked to evaluate and compare     characteristics of the BD NEXT pen needle versus their usual pen needle when used for all     their pen injections performed at home. Since injection experience may vary according to the     type of pen device used, equal numbers of subjects will be recruited who are users of three     of the most commonly used insulin pen injectors.   "
109603|NCT01851382|"     Background:      - Researchers often collect samples from healthy volunteers to further their research. These     samples can help better understand serious side effects and complications of transplant     treatments in patients. This study will collect saliva samples from healthy volunteers.      Objectives:      - To collect saliva and blood samples from healthy volunteers for research studies.      Eligibility:      - Healthy men ages 30-70 years for Phase I of the study.      Design:        -  Participants will be screened with a medical history questionnaire. They will also have          a brief oral exam to check for any mouth infection.        -  Participants will provide a saliva sample. The collection process will take about 5          minutes.        -  No treatment will be given as part of this study.   "
109564|NCT01852123|"     In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made     where there is evidence of heart muscle damage using a blood test to measure the heart muscle     protein troponin. A new a more sensitive troponin test may help us to identify patients with     myocardial infarction more easily.      The investigators propose to evaluate whether use of a novel high-sensitivity troponin test     to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased     sensitivity does not reduce specificity for the diagnosis, then this new test will improve     patient outcome through better targeting of therapies for coronary heart disease. However, if     increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given     inappropriate cardiac medications with potentially detrimental outcomes.      In ten secondary and tertiary care hospitals across Scotland, the investigators will     undertake a stepped wedge cluster randomized controlled trial of the implementation of a     novel high-sensitivity troponin test. The primary end-point will be the one-year rate of     cardiovascular death or recurrent myocardial infarction. This will establish whether the     introduction of this high-sensitivity troponin test into routine clinical practice is     beneficial to patient management and outcomes.      A subset of patients will be asked to give consent for inclusion into a sub-study that will     permit storage of blood samples and will require the completion of a survey during the index     admission and after 6 and 12 months of follow up.   "
109565|NCT01852110|"     The purpose of this multicenter trial is to assess the efficacy and safety of MK-7622     compared with placebo as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for     the symptomatic treatment of participants with mild to moderate Alzheimer's Disease (AD). The     trial consists of two stages: Stage 1 and Stage 2. Participants in Stage 1 will be randomized     to receive either placebo or MK-7622 45 mg once daily. In Stage 2, participants will be     randomized to receive either placebo, or MK-7622 5, 15 or 45 mg once daily. Participants will     be enrolled in only one stage. Interim analyses will be performed in both Stage 1 and Stage 2     to determine whether the trial should continue. Duration of each stage is approximately 26     weeks; all participants receive placebo at some time during the trial. The primary study     hypotheses are the following: Stage 1 - MK-7622 45 mg once daily is superior to placebo in     improving cognition in participants with mild to moderate AD as assessed by mean change from     baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11)     at Week 12; Stage 2 - At least one of the top two doses of MK-7622 (15 mg once daily, 45 mg     once daily) is superior to placebo in improving cognition in participants with mild to     moderate AD as assessed by mean change from baseline in ADAS-Cog11 at Week 12.   "
109584|NCT01851629|"     The purpose of this study is: (1) to establish assessment techniques (in our laboratory) to     identify the functional integrity of long spinal tracts associated with adaptive walking     recovery post-spinal cord injury and (2) to preliminary investigate locomotor outcomes     associated with an adaptive locomotor training approach post-spinal cord injury.   "
109585|NCT01851616|"     The objective of this study is to examine gastric emptying and satiety hormones after oral     glucose stimulation in 2 different concentrations in morbidly obese patients after     Roux-en-Y-gastric-Bypass.   "
109566|NCT01852097|"     Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory     conditions that usually affect the colon and the small intestine. Between 30 to 45% of     patients with IBD do not take their treatment as prescribed by their health care team     (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA)     provides a theoretical framework to develop adherence interventions that are patient-centred     (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the     medication but there are barriers beyond their control, such as not understanding the     instructions (practical barriers). Intentional non-adherence is the result of the beliefs     affecting the patient's motivation to continue with treatment (perceptual barriers).      Aims        1. To develop an internet-based intervention to address perceptual and practical barriers          to adherence to medicine for IBD.        2. To determine whether the intervention is effective based on change in both types of          barriers.      Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD; currently     prescribed azathioprine, mesalazine, and/or adalimumab.      240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will     take part in the study. An online pilot Randomised Controlled Trial will allocate the     participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or     Treatment as Usual group. On first visiting the website, participants will be screened for     eligibility and asked for consent before answering the questionnaires. The website will     assign intervention modules to be completed based on an individual's profile.      Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month     follow-ups.      Potential Impact A CBT based online intervention tailored to personal needs and concerns may     benefit a large number of patients with low costs for the national healthcare services. A     website can be accessed at a time and place convenient to the patient.   "
109567|NCT01852071|"     In this current study, the investigators will determine whether using a lentiviral vector     (based on HIV-1) will be more effective and safer at gene transfer to hematopoietic stem     cells compared to previous gene transfer vectors based on murine (mouse) retroviruses for     ADA-deficient SCID. The level of gene transfer in blood cells and immune function will be     measured as endpoints.   "
109568|NCT01852058|"     This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA for the     treatment of urinary incontinence due to neurogenic detrusor overactivity in patients who     successfully completed Study 191622-120.   "
109569|NCT01852045|"     This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of     urinary incontinence due to neurogenic detrusor overactivity in pediatric patients between     the ages of 5 to 17 years.   "
109570|NCT01852032|"     The purpose of this study is to compare the imaging performance of an investigational breast     computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast     tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis     images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.   "
109571|NCT01852019|"     To demonstrate that patients treated with cangrelor can be directly switched to oral     prasugrel and that patients treated with prasugrel can be switched to cangrelor without a     significant decrease in the extent of inhibition of platelet aggregation.   "
109629|NCT01851031|"     The aim of the study was to compare the new approach and the retromandibular approach, so     that the therapeutic effect and the advantages of the new approach would be clear.   "
109935|NCT01847014|"     SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm,     Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to     psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the     long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401     study.   "
109572|NCT01852006|"     Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive     pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia)     and/or dynamic respiratory mechanics (e.g., bronchodilators). Although these approaches yield     meaningful symptom improvements there remains many COPD patients incapacitated by dyspnea.     Accumulating evidence suggests that abdominal binding (AB) is a potentially novel method of     improving respiratory muscle function and, by extension, dyspnea and exercise tolerance in     COPD. Thus, the purpose of this randomized, cross-over study is to test the hypothesis that     AB improves exertional dyspnea and exercise tolerance in symptomatic patients with COPD by     improving dynamic respiratory muscle function. To this end, the investigators will examine     the effects of AB on detailed assessments of baseline pulmonary function (spirometry,     plethysmography), dyspnea (sensory intensity & affective responses), neural respiratory drive     (diaphragm EMG), contractile respiratory muscle function (esophageal, gastric &     transdiaphragmatic pressures), ventilation, breathing pattern and cardiometabolic function     during symptom-limited constant load cycle exercise (75% Wmax) in 20 patients with GOLD stage     II/III COPD.   "
109573|NCT01851993|"     Dyspnea refers to the awareness of breathing discomfort that is typically experienced     during exercise in health and disease. In various participant populations, dyspnea is a     predictor of disability and death; and contributes to exercise intolerance and an adverse     health-related quality-of-life. It follows that alleviating dyspnea and improving exercise     tolerance are among the principal goals of disease management. Nevertheless, the effective     management of dyspnea and activity-limitation remains an elusive goal for many healthcare     providers and current strategies aimed at reversing the underlying chronic disease are only     partially successful in this regard. Thus, research aimed at identifying dyspnea-specific     medications to complement existing therapies for the management of exertional symptoms is     timely and clinically relevant. The purpose of this study is to test the hypothesis that     single-dose inhalation of nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will     improve the perception of dyspnea during strenuous exercise in health, young men. To this     end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled     ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm EMG),     ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory     muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective     responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing     in healthy, men aged 20-40 years.   "
109586|NCT01851603|"     This is a brief inpatient study to determine the safety of a new drug in healthy people.   "
109587|NCT01851590|"     The current study is conducted to corroborate the previous observational clinical trial with     more valid methods and a more clinically relevant experimental design. This study aims to     compare efficacy, safety, and cost between topically administered 30% resin lacquer for the     treatment of dermatophyte toenail onychomycosis and the current best practices: topical 5%     amorolfine and systemic terbinafine.   "
109613|NCT01851239|"     Venous thromboembolism(VTE) is the third most common cardiovascular complication among     hospitalized patients, and can even cause death. VTE often occurs in intensive care patients     and there had been many efforts to prevent such complication. The American College of Chest     Physicians (ACCP) had published evidence-based clinical practice guideline for VTE     prophylaxis.      This study focuses on how VTE prophylaxis is being performed in both medical and surgical     ICUs in a single University hospital, and sees the differences in such prophylactic patterns.   "
145279|NCT01382797|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37     when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).   "
109574|NCT01851980|"     Breathlessness on exertion is a common and troublesome complaint of individuals with     restrictive lung disorders. In these adults, breathlessness contributes to physical     activity-limitation and avoidance and an adverse health-related quality-of-life, often in a     self-perpetuating cycle. It follows that alleviating dyspnea and improving exercise tolerance     are among the principal goals in the management of adults with restrictive lung disorders.     Nevertheless, effective management of breathlessness and physical activity-limitation remains     an elusive goal for many healthcare providers and current therapies (e.g., antifibrotic     agents, oxygen, exercise training) are only partially successful in this regard. Thus,     research aimed at identifying breathlessness-specific medications to complement existing     therapies for the management of physical activity-related breathlessness in restrictive lung     disorders is timely and both clinically and physiologically relevant. The purpose of this     randomized crossover study study is to examine the acute effects of two doses of inhaled     nebulized furosemide (a loop diuretic) on the perception of breathlessness during     laboratory-based cycle exercise in healthy, young men in the presence of an external thoracic     restriction to mimic a 'mild' restrictive lung deficit. To this end, the investigators will     compare the effects of inhaled 0.9% saline placebo and inhaled furosemide (40 mg and 120 mg)     on detailed assessments of breathlessness (sensory intensity and affective responses) and its     physiological determinants (ventilation, breathing pattern, dynamic operating lung volumes,     cardio-metabolic function) symptom-limited, high-intensity, constant-work-rate cycle exercise     testing with external thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary     deficit in healthy, men aged 18-40 years.   "
109575|NCT01851967|"     This study aims to evaluate efficacy and acceptability of the Chinese language version of     MoodGYM as a therapeutic intervention in treating symptoms of depression in community     dwelling Chinese Americans in the Boston area.      Hypothesis 1: Participants enrolled in MoodGYM will show a significant decrease in depressive     symptoms after completion of the 5 modules.      Hypothesis 2: Participants enrolled in MoodGYM will show significantly improved dysfunctional     thinking.      Hypothesis 3: Participants enrolled in MoodGym will rate this program as culturally     acceptable.   "
109576|NCT01851954|"     The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is     used for premature infants with ureaplasma.   "
110081|NCT01845103|"     This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery     System. The purpose of this study is to demonstrate that the 30 day mortality rate among     patients who are treated with this device is less than the historical rate plus a     non-inferiority margin.   "
110082|NCT01845090|"     To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in     hemodialysis patients.   "
109577|NCT01851720|"     Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache     management is complex, requiring a balance between pain control and preservation of     neurological assessment. Sufficient pain control can be achieved with narcotics, however,     these carry numerous undesirable side effects. Most critically, all narcotics can result in     respiratory depression and sedation. For patients who present without neurological defects     but debilitating pain, management is particularly challenging. The sedative effect of     narcotics confounds the management of these patients by interfering with the neurological     examination. Pain management is also a significant concern for patient's families as they     observe suffering without full understanding of the importance of preserved mental status. In     order to control the pain associated with SAH headaches, the use of narcotics is often     required despite the risks. This standard therapy involves an IV bolus dose delivered by the     provider regularly as needed for pain control. A common approach to reduce pain in other     patient populations, including acute pain relief following major spine surgery, is patient     controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics     through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that     this approach to pain relief for SAH headaches will result in lower pain scores, greater     patient and family satisfaction scores, and increased patient safety with lower narcotic     doses minimally interfering with neurological assessment.   "
109578|NCT01851707|"     The purpose of this study is to investigate the safety and efficacy of multiple dose levels     of the investigational product (study drug), IPI-145, in combination with methotrexate     compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid     Arthritis.   "
109579|NCT01851694|"     In recent years, diabetes has emerged as one of the most significant co-diseases that many     Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when     either the body does not make enough insulin or the body does not respond correctly to this     insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps     carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic     fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with     CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little     understanding of CFRD and the best options for treatment remain unclear.      The purpose of this research study is to examine and understand the various mechanisms that     contribute to CFRD and gain a better understanding of potential means to treat CFRD. In     particular, we plan to study the effects of incretin hormones that can enhance insulin     production in CF patients.   "
109580|NCT01851681|"     In order to prevent infections and complications, it has been initially established with the     dental implant placement protocol that pre- and post-operative antibiotics should be     prescribed to the patient receiving dental implants. There have been many antibiotic regimens     used in the attempt to minimize the risks of infections and consequently, increasing the     survival rate of dental implants placement procedures. However, issues about bacterial     resistance have been raised recently concerning the extensive use of antibiotics. The primary     objective of this study is to find out whether giving antibiotics before or after implant     placement would significantly influence crestal bone loss around dental implants. One study     group will receive one dosage of antibiotics before implant placement followed by     post-operative intake of antibiotics for 7 days. Another group will receive the antibiotics     in one single preoperative dose followed by an identical placebo for 7 days. Questionnaires     for pain and interference with daily activities assessment to be filled for the first     postoperative week will be distributed to participants. Signs of postoperative morbidity will     be recorded at 1 and 3 weeks following the surgery, and both clinical and radiographic data     will be collected at 4 months postoperative to assess the implants status. A radiographic     follow-up will be done 1 year after the surgery. Peri-implant crevicular fluid levels of 3     known immunological markers for bone loss (MMP-8, sRANKL and OPG) will be measured at 1-, 3-     and 16-weeks follow-ups. The findings from this study might allow clinicians to establish the     ideal antibiotic regimen with minimal risk exposure to bacterial resistance.   "
109588|NCT01851577|"     The purpose of this study is to determine the efficacy of Family Foundations that is to be     delivered concurrently with home visiting. Delivered prenatally and postnatally, Family     Foundations is a coparenting prevention program for new mothers and fathers that is designed     to optimize child outcomes by teaching parents how to work together in raising their child.     Using a randomized clinical trial design, families will be assigned to receive Family     Foundations + home visiting or home visiting alone. A comprehensive assessment is     administered at baseline and then at post-intervention, and 9 and 18 months later. It is     hypothesized that families receiving Family Foundations will improve in their resolving of     conflict from pre-intervention through follow-up. Additional anticipated outcomes are that     those receiving the intervention will have more involved fathers, mothers and fathers will     report less conflict, and children will have better emotional and behavioral outcomes     relative to those who receive home visiting alone.   "
109589|NCT01851564|"     The mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy     may fail in 15-25% of patients. The self-expandable metal stent has been described in case     series as having a very high efficacy at control of haemorrhage from oesophageal varices when     used as rescue therapy. This randomised controlled trial aims to assess for any potential     superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy     for bleeding oesophageal varices.   "
109590|NCT01851551|"     This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a     single arm, open label study evaluating VSLI plus rituximab in adults with aggressive     relapsed or refractory non-Hodgkin's lymphoma.   "
109630|NCT01851018|"     The purpose of this study is to compare toxicities between 2 external beam radiation     fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard     use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy     per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and     safety of such a treatment regimen in prostate cancer. It may also set base for a larger     randomized trial.   "
110083|NCT01845077|"     The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed     fixed dose combination (FDC) tablets containing linagliptin & metformin and the single     tablets of linagliptin and metformin when administered singularly.   "
109591|NCT01851538|"     The Bio-SHiFT study aims to investigate whether disease progression in individual patients     with chronic heart failure (CHF) can be accurately assessed by serial measurements of     disease-related (novel) biomarkers. Secondary objectives of the study include comparison of     2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking     with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic     measurements to clinical outcome.      Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged     18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of     inclusion and at follow-up visits, which are performed every 3 months until the end of the     scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up     visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed     in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary     endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular     assist device implantation, and re-hospitalization for the management of acute or worsened     heart failure.   "
109592|NCT01851525|"     Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However,     achievement of complete& durable isolation of the pulmonary veins (PVs) is challenging,     primary limited both by operator experience and also the limits of currently available     ablation technology. Direct contact force sensing (CFS) is a novel technology that may help     to ensure adequate lesion delivery. CFS may also help to improve the safety profile of     catheter ablation. The purpose of this study is to compare two strategies of wide antral PV     isolation plus linear ablation for persistent AF:        1. guided by contact force sensing (CFS) OR        2. blinded to contact force sensing (CFS) - i.e. standard approach   "
109593|NCT01851512|"     This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability,     safety and pharmacokinetic characteristics of human chorionic gonadotropin between two     recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy     subjects. The subjects will injected with these two injections at the the 21day-interval of     time and their conditions including vital signs, blood, clinical examination will be     carefully observed.   "
109594|NCT01851499|"     Randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized PEA     (Normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed by     1 x 12 weeks treatment period.   "
109595|NCT01851486|"     The role of alpha2 receptor agonist on pain perception and modulation will be examined. In     addition whether this is mediated through the opioid system will be examined. Pain perception     and modulation will be examined before and after administration of Clonidine or placebo     together with Naloxone or saline.   "
109596|NCT01851473|"     Background:      - Scientists are studying medications that may be useful in treating cocaine addiction. It is     important in these studies to know whether study participants are always taking their     medications as directed. This study will look at two chemicals to see if they can be used to     determine whether participants are taking their medications as directed. Because     acetazolamide and quinine can be measured in plasma and urine, they are good test subjects     for this study. They will be given alone, and combined with intravenous cocaine.      Objectives:      - To see how they body handles acetazolamide and quinine alone, and when combined with     cocaine.      Eligibility:      - Individuals between 18 and 50 years of age who have smoked or used IV cocaine for at least     one year and at least three times per month during the three months prior to screening. Urine     test positive for cocaine within the prior 6 months      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will also be collected.        -  This study will involve a 12-day inpatient stay at the National Institutes of Health.        -  On days 1, 5, and 10, participants will receive a dose of cocaine. Blood, urine, breath,          and saliva samples will be collected up to 18 times a day for up to about 24 hours.        -  On days 2, 3, 4, and 5, participants will receive acetazolamide. Regular blood samples          will be collected on Day 4.        -  Day 6 is a wash-out day with no drugs or blood tests.        -  On days 7, 8, 9, and 10, participants will receive quinine. Regular blood samples will          be collected on Day 9.        -  On day 11, blood, urine, breath, and saliva samples will be collected in the early          morning. Participants will be able to leave later in the day.   "
109651|NCT01850745|"     Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to     achieve sustained virological response (SVR). The aim of our study is to evaluate the     efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of     pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed     447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group     (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and     MSP-validation group (recruited 2007-2009, n=169).   "
109597|NCT01851460|"     Background:      - Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called     chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited     disorder that affects how white blood cells function. Liver abscesses in people with CGD     often require surgery to remove them and treat the infection. However, some people with CGD     cannot have full surgery because it would be too risky. Researchers want to try a procedure     called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done     without a major operation. This study will see if RFA is a safe and effective treatment for     liver abscesses in patients with CGD.      Objectives:      - To see if RFA is a safe and effective treatment for CGD-related liver abscesses.      Eligibility:      - Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be     treated with surgery.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies will be performed on the liver.        -  Participants will have RFA for the abscesses. RFA is an image-guided technique that          heats and destroys specific tissue, such as tumor tissue. It will target any abscesses          on the liver.        -  After the procedure, participants will stay in the hospital for monitoring before being          released.        -  Participants will have regular follow-up visits for up to 1 year after treatment. Blood          and urine samples will be collected. Additional imaging studies will be performed.   "
122527|NCT01682174|"     The purpose of this study is to assess whether added food ingredient(s) affect glycaemic     responses to a liquid meal tolerance test (LMTT).   "
109598|NCT01851447|"     Background:      - Some kinds of muscular dystrophy affect the skeletal muscle membrane. In these conditions,     the muscle membrane is more fragile. This affects how the muscles contract and relax, which     causes movement problems. Researchers are looking at several muscle enzymes, or chemicals     that affect how muscle cells function. By studying changes in these enzymes, they may be able     to better understand how muscular dystrophy affects the cells. Researchers want to collect     biomarkers (chemicals from blood samples) from people with fragile sarcolemmal muscular     dystrophy. This information may provide better treatments for this condition.      Objectives:      - To study biomarkers that may affect the muscles of people with fragile sarcolemmal muscular     dystrophy.      Eligibility:      - Individuals at least 18 years of age with fragile sarcolemmal muscular dystrophy.      Design:        -  Participants will be screened with a medical history and physical exam.        -  Participants will be asked to come for four visits to the National Institutes of Health          Clinical Center. The visits will be at least 2 months apart. Each visit will require          participants to stay for 5 days at the clinical center.        -  During each visit, participants will provide frequent small blood samples. These samples          will be collected while at rest and after physical exercise.        -  Participants will also have a physical therapy assessment. They will perform standard          motor function tests and imaging tests (MRI, MRS). These tests may take up to 1 hour          each time.        -  Treatment will not be provided as part of this study.   "
109599|NCT01851434|"     Background:      - Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience     optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance     imaging (MRI) scans is often greater than that seen in tests given during regular doctor's     visits. Even though MRI is a helpful tool for studying optic neuritis and MS, more     information is needed on how MS symptoms show up on MRI scans. Researchers want to use MRI     scans to track changes in the optic nerve after an optic neuritis episode. This approach will     help them study the relationship between optic neuritis and MS.      Objectives:      - To collect more information about the relationship between optic neuritis and multiple     sclerosis.      Eligibility:        -  Individuals between 18 and 50 years of age who have new optic neuritis.        -  Individuals between 18 and 50 years of age who have new symptoms of MS other than optic          neuritis.        -  Healthy volunteers between 18 and 50 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. They may provide          blood or urine samples.        -  Participants with optic neuritis or other MS symptoms will have a baseline study visit.          They will have a physical exam and full eye exam. To look for signs of MS, they will          have evoked potential tests to see how the body responds to stimulation. They will also          have an MRI scan to study any changes in the brain and optic nerves.        -  After the first visit, participants will have steroid treatment for 5 days for the optic          neuritis.        -  Additional study visits will be given 1, 3, 6, 9, and 12 months after the baseline          visit. The tests from the first visit, including the MRI scans, will be repeated at          these visits.        -  Healthy volunteers will have a baseline study visit. They will have a physical exam and          full eye exam. They will have evoked potential tests to see how the body responds to          stimulation. They will also have an MRI scan to study any changes in the brain and optic          nerves.        -  Healthy volunteers will have additional study visits 2 and 11 months after the baseline          visit. The tests from the first visit, including the MRI scans, will be repeated at          these visits.   "
109600|NCT01851421|"     Background:      - Melanocortin receptors are proteins in the body that help send messages between body     systems. One such receptor, the melanocortin 3 receptor (MC3R), is important for regulating     body weight. Differences in MC3R can affect fat metabolism - or how the body handles fat.     Some people who have changes in the MC3R genetic code are heavier than those who do not have     these changes. These changes are found more often in African Americans. Researchers want to     study the MC3R in African American adults to see how these changes may affect fat metabolism.     They will look at overweight adults with either the most common genetic code for the MC3R or     a rare variant.      Objectives:      - To study the role of the MC3R in body weight and fat metabolism.      Eligibility:        -  Healthy African American volunteers between 18 and 55 years of age.        -  Volunteers must be overweight (body mass index at least 30 kg/m2) but weigh less than          450 lbs.      Design:        -  The study consists of an outpatient screening visit and a 7-day inpatient visit with          dietary studies.        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. (Participants will need to fast for 10 hours before giving blood          samples.) A body scan will be given to determine fat, bone, and muscle content.          Participants will complete a 3-day dietary assessment to record their food and drink          consumption. They will also have an exercise test to look at heart and lung function.        -  Participants will have a 7-day inpatient stay. They will have a regular diet for the          first 3 days of the study. For the final 4 days, they will have a diet with a higher fat          content.        -  During the inpatient visit, participants will have the following study procedures:        -  Body measurements        -  Daily exercise routine        -  Imaging studies of the body        -  Measurement of a whole day s energy expenditure (spending one day in metabolic          chamber-day 5)        -  Frequent blood samples        -  Urine collection for 24 hours (days 3 and 7)        -  Fat biopsy (collection of a small sample of fat tissue from under the skin on the          abdomen)        -  Insulin and metabolism tests while eating the two different diets (day 4 and day 7).        -  After the final insulin and metabolism test, participants will be discharged from the          study.   "
109601|NCT01851408|"     This phase II portion of the trial is studying the side effects and best dose of temsirolimus     when given together with sorafenib and to see how well they work in treating patients with     metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may     also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib     together with temsirolimus may kill more tumor cells.   "
109609|NCT01851304|"     A diet high in easily obtained energy-dense foods leads to the problems of overweight and     obesity common in the developed world. Foods enriched with fiber or bitter compounds may     increase satiety and decrease energy intake. This intervention will measure the effectiveness     of coffee melanoidins, bread melanoidins, beta-glucans, and a Gentiana lutea L. extract in     both a free or encapsulated form to decrease energy intake and modify the physiological     markers of satiety in the short term. In particular bread (fiber) and a pudding (Gentiana     lutea L. extract) will be used as tasty food matrices in the study.   "
109610|NCT01851278|"     The purpose of this study is to compare the small and large dose of corticosteroid used in     intraarticular injection of wrist.   "
109602|NCT01851395|"     Background:      - People with lung cancers unfortunately commonly succumb to their disease. Some agree to     donate their bodies to cancer research that may help the medical community better understand     these diseases. Studies of lung cancer tumor tissue obtained soon after death may be used to     answer questions about the origins, progression, and treatment of lung cancer. Researchers     want to conduct a study that involves planned collection of lung cancer tumor tissue shortly     after death. To do so, they will arrange to provide inpatient hospice care for people with     non-small cell lung cancer.      <TAB>      Objectives:      - To collect lung cancer tissue biopsy samples as soon as possible after death.      Eligibility:      - Individuals who have non-small cell lung cancer and are planning to receive end-of-life     hospice care.      Design:        -  Participants will agree to receive inpatient hospice care at the National Institutes of          Health Clinical Center. Full details on end-of-life instructions will be noted.        -  An autopsy will be performed at the clinical center within 3 hours of death. Tumor          tissue will be collected from the primary site of cancer and from any areas of the body          to which the cancer has spread.        -  Participants will not receive further cancer treatments as part of this study. This is a          tissue collection study only.   "
109645|NCT01850823|"     A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare     the Clinical Equivalence of Mometasone Nasal Spray (Watson Laboratories, Inc) with NASONEX®     Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal     Allergic Rhinitis   "
109604|NCT01851369|"     Background:      - TRC102 is a new cancer treatment drug that may help improve the results of chemotherapy. It     blocks tumor cells' attempts to repair damaged DNA, which may allow chemotherapy to kill the     cells more easily. Researchers want to see how well it works with temozolomide, a     chemotherapy drug that is designed to damage tumor cell DNA. These drugs will be given to     people who have advanced solid tumors or lymphomas that have not responded to earlier     treatments.      Objectives:      - To test the safety and effectiveness of TRC102 and temozolomide for advanced solid tumors     and lymphomas.      Eligibility:      - Individuals at least 18 years of age who have advanced solid tumors or lymphomas that have     not responded to earlier treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Tumor samples may also be collected. The size and location of          the tumors will be determined with imaging studies.        -  Participants will take TRC102 and temozolomide for 28-day cycles of treatment. They will          take temozolomide and TRC 102 by mouth once a day on days 1-5. Participants will keep a          diary to record doses and any side effects.        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples          will also be collected.        -  Participants will continue their treatment as long as the cancer does not grow and there          are no severe side effects.   "
109605|NCT01851356|"     Background:      - Studies have shown that inflammation plays an important role in depression. Brain     inflammation may contribute to depression, and may make it more difficult to treat some kinds     of depression with current therapies. Researchers want to use magnetic resonance imaging     (MRI) and positron emission tomography (PET) scanning to study inflammation in the brain. To     do so, they will use a contrast agent, which is a chemical that can show inflammation during     an imaging study.      Objectives:      - To see if people with major depressive disorder have increased inflammation in the brain.      Eligibility:      - Individuals at least 18 years of age who have major depressive disorder.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide blood samples before the scanning sessions.        -  Participants will have a PET scan after the screening visit. They will have a dose of          the contrast agent before the study. This scan will look for possible brain          inflammation.        -  Participants will also have an MRI scan. This scan will take pictures of the brain for          comparison studies.        -  Treatment will not be provided as part of this study.   "
109606|NCT01851343|"     Background:      - Bone marrow stromal cells (BMSCs) are cells that can develop into other tissue types,     including bone, cartilage, marrow, and blood cells. However, BMSCs are not stem cells there     is no evidence that after infusion into another person that BMSCs change into any other     cells. Research suggests that BMSCs can travel to different parts of the body and work with     immune cells to reduce inflammation and help repair damaged tissues. BMSC infusions have been     used in tests to treat moderate to severe inflammatory bowel disease, like Crohn's disease     (CD) or ulcerative colitis (UC). These tests have shown some good results, but more research     is needed to study their safety and effectiveness. Researchers want to see how well BMSC     infusions work to treat CD and UC. The BMSCs will be collected from volunteer donors.      Objectives:      - To look at the safety and effectiveness of BMSC infusions for moderate to severe CD and UC.      Eligibility:      - Individuals between 18 and 65 years old with moderate or severe inflammatory bowel disease     (CD or UC) that has not responded to standard treatment.      Design:        -  Participants will have two screening visits. The first will be 15 to 30 days before the          first BMSC infusion. The second will be within 14 days of the first BMSC infusion.        -  At the first screening visit, participants will have a physical exam and medical          history. They will provide blood, urine, and stool samples. They will also give          information about their symptoms and quality of life.        -  At the second screening visit, participants will have their vital signs (like blood          pressure and heart rate) measured. They will also provide blood samples, and have a          colonoscopy with biopsies.        -  During treatment, participants will have one BMSC infusion per week for 4 weeks. Blood          and urine samples will be collected at each treatment visit.        -  One week after the last infusion, participants will have a study visit. The tests from          the first and second screening visits will be repeated.        -  There will be six follow-up visits at 1, 2, 3, 6, 12, and 24 months after the last study          visit. Participants will repeat the tests from the first screening visit.   "
109607|NCT01851330|"     This study is to evaluate the safety, tolerability, and antiviral efficacy of     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV)     administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV     infection.   "
109608|NCT01851317|"     This study is designed to investigate the relationship between patients' position and     endotracheal tube intracuff pressure in the pediatric population.   "
109611|NCT01851265|"     This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure     the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after     eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take     olaparib capsules daily and study assessments will be recorded for 6 months (minimum).     Treatment can continue for as long as the patient is benefitting. Throughout the study     patients will be monitored for any side effects.   "
109614|NCT01851226|"     Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques     in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform     enough cases to grasp this technique. The methods of ERCP training include hands-on teaching,     training on different kinds of simulators, training on ex-vivo or live anesthetized porcine     stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training.      Selective cannulation is considered the most difficult and challenging part of learning ERCP.     There is not an optimal time for trainees to attempt cannulation during hands-on ERCP     training. The time used for attempting cannulation by trainees was 5min or 10min in several     centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt     cannulation for about one year. The incidence of post-ERCP pancreatitis, the major     complication related to cannulation, was 4.0%, which was comparable with previous studies.      The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation     would increase success rate of selective cannulation and help to improve skills more quickly.     At the meantime, with actively verbal or hands-on assistance from the instructor during     performance of trainees, the risk of complications would not increased with a longer time to     attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study     was designed to evaluate the effects of different periods of time for trainees to attempt     selective cannulation on success rate of cannulation, self-satisfaction of performance and     post-ERCP pancreatitis.   "
109646|NCT01850810|"     The objective of this trial is to evaluate a nutritional product for people with Diabetes.   "
110097|NCT01844895|"     The purpose of this study is to implement a substudy in approximately 120 rheumatoid     arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax     and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC)     Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled     syringe.   "
109615|NCT01851213|"     This study is a prospective, multicenter, observational study to characterize utilization     patterns of the FoundationOne™ test by oncologists under conditions of routine clinical     practice in the US. The study will also examine impact of test results on subsequent clinical     decisions regarding choice of therapy. The planned duration of the study is at least 2 years     with 1 year for patient recruitment and a minimum 1-year follow-up period for each patient.     Any patient for whom the treating physician has ordered a FoundationOne™ test and a report is     delivered is eligible for participation on the study. Eligible patients from participating     sites will be enrolled sequentially during the 1-year enrollment period. Sites will be     required to maintain an enrollment log of all patients for whom the FoundationOne™ test has     been ordered and document patient disposition and reasons for non-participation. All     treatment decisions and clinical assessment will be made at the discretion of the treating     physician per usual care and are not mandated by study design or protocol. Informed consent     will be obtained from eligible patients prior to study entry.   "
109616|NCT01851200|"     The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ     cell tumors.   "
109617|NCT01851187|"     Pregnancy or childbirth is a kind of persistent and strong source of stress for pregnant     women. Prenatal and intrapartum negative emotions not only damage the mental health of     pregnant women, but also have a negative impact on the mode of delivery, labor, postpartum     complications and neonatal outcomes . Due to considerations for the effect on the fetus,     there is concern of the use of drug treatment for depression during pregnancy. Therefore,     psychological interventions have an important role. According to the WHO global survey in     Asia 2007-08, China had the highest overall rate of caesarean section (46.2%), and also had     the highest rate of caesarean section without indication (11.7%). The embarrassing first in     the world of caesarean section rate was causing widespread concern in China. Recently, the     Chinese government has launched a project named promoting the rate of natural childbirth and     protecting the health of mother and child, trying to reduce the cesarean section rate     especially that without medical indication. Therefore, examining if emotional management is     effective in reducing negative emotions of pregnant women as well as decreasing the rate of     cesarean section is an important research question. Our study aims to help the pregnant women     control their anxiety, depressive feelings and other negative emotions by emotional     self-management group training and we examine if this can reduce the incidence of depression     and improve delivery outcomes.   "
109618|NCT01851174|"     To determine whether the occurrence of adverse events can be decreased by moving to a     bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of     unresectable/metastatic pancreatic cancer.   "
109619|NCT01851161|"     This clinical trial studies prone patient positioning in reducing tumor motion and improving     breathing reproduction in patients with lung cancer undergoing radiation therapy. Prone     patient positioning during radiation therapy may help kill tumor cells without harming normal     tissue.   "
109620|NCT01851148|"     The aim of the present study is to determine the extend to which OMT is effective on a sample     of subjects affected by migraine evaluated using the headache impact test (HIT-6)     questionnaire.   "
109621|NCT01851135|"     The main objective of the study is to investigate the determinants of the quality of life in     children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific     impact of neuropsychological deficits. In fact, cognitive impairment is currently considered     as one of the most pervasive features of this genetic disorder but its relationship with the     worsening of quality of life found in this population has not been directly investigated to     date.      Secondary objectives of this study are (i) to compare neuropsychological and quality of life     measures between patients and healthy controls matched by age, gender and education level,     (ii) to contrast neuropsychological deficits incidence between patients and controls, and     (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life.      The main hypothesis of this study is that the neuropsychological impairment classically     identified in this clinical population will be associated to the quality of life's worsening     both in children and adults.   "
109622|NCT01851122|"     The amino acid l-theanine (the active ingredient in green tea) is considered to have a     calming effect without causing sleepiness. This study evaluates whether l-theanine affects     blood pressure, heart rate, alertness, and sense of well-being.   "
109623|NCT01851109|"     The primary purpose of this study is to evaluate the effect of systematic identification and     genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove     both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in     Seattle, WA.   "
109624|NCT01851096|"     Heat shock protein 90 (Hsp90) is a chemical in the body that is involved in the promotion of     cancer. SNX-5422 is an experimental drug that blocks Hsp90.   "
109625|NCT01851083|"     Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability in     children ages 1-14 years old. There are no effective therapies to treat secondary brain     injury and the post-injury response of CNS apoptosis and neuroinflammation. This study is a     follow-up trial from a previously performed Phase I trial that demonstrated the safety and     potential CNS structural preservation effect of intravenous autologous bone marrow     mononuclear cells (BMMNC) after severe TBI in children. (Cox, 2011) The study is designed as     a prospective, randomized, placebo controlled, blinded Phase 2 safety/biological activity     study. The investigators hope to determine the effect of intravenous infusion of autologous     BMMNCs on brain structure and neurocognitive/functional outcomes after severe TBI in     children.   "
109626|NCT01851070|"     Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary     objective of this study is to evaluate the safety, tolerability and feasibility of a single     intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at     12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who     have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who     have had an incomplete response to at least one TNF-alpha inhibitor.   "
110280|NCT01842516|"     Primary        -  To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral          dose in healthy male subjects        -  To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male          subjects   "
109631|NCT01851005|"     Emergence of elderly patients from anesthesia may face with cognitive dysfunction or     agitation such as delirium. There are reports that using dexmedetomidine as a adjuvant for     general anesthesia decreased emergence-agitation in children and dexmedetomidine may be used     for treating deliriums. Thus, we thought that dexmedetomidine as a adjuvant agent may be a     help to smooth emergence from anesthesia in elderly.      The aims of this study were to investigate the recovery characteristics (time to recovery of     consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and     Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs     during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients     undergoing elective surgery.   "
109632|NCT01850992|"     The purpose of this study is to identify the mechanism(s) by which OSA exacerbates the     age-linked decline in systemic testosterone concentrations by conducting a randomized order     sham-controlled crossover study that dynamically evaluates the entire hypothalamic-pituitary     testicular axis across a wide age range.   "
109633|NCT01850979|"     Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune, chronic,     inflammatory and systemic disease which affects most commonly the lacrimal and salivary     glands.The ocular treatment is focused in increasing lubrification and decreasing     inflammation with topical autologous serum, topical immunosuppressive agents and     corticotherapy. Use of topical immunosuppressants has increased in recent years because the     topical corticotherapy leads to ocular complications. The most used immunosuppressant is     cyclosporine. Tacrolimus , another immunosuppressant, has been used in treatment of immune     and inflammatory ocular diseases.This study describes a prospective controlled double-blinded     randomized study of the clinical outcome of SS dry eyes patients treated with 0.03%     tacrolimus eye drops. As secondary purposes, outcome of dry eye symptoms and any ocular     symptoms of the eye drops were also questioned to the patients.   "
109634|NCT01850966|"     To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52     weeks in patients with rheumatoid arthritis in clinical practice   "
109635|NCT01850953|"     The objective of this study is to determine the mechanisms by which varenicline, an effective     smoking cessation treatment, protects against relapse. Varenicline will be administered in     smokers with schizophrenia and control smokers using a randomized, double-blind, cross-over     design. Smokers will be asked to stop smoking overnight; the next day the ability to resist     smoking will be assessed in a laboratory smoking lapse paradigm. Measures of tobacco craving,     reinforcement and withdrawal-related cognitive dysfunction will be correlated with time to     lapse. The results could have significant clinical implications by identifying mechanisms by     which smokers with schizophrenia are at more risk for relapse than the general population,     leading to the development of more effective smoking cessation therapies.   "
109636|NCT01850940|"     This is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting     dose of tolvaptan is 15 mg daily orally. The dose may be titrated on the next day at 15 mg     intervals up to 60 mg daily according to the serum sodium level response.Serum sodium level,     change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight,     edema, renal function, mortality and liver-related complications on day 7 and day 30 to     evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.   "
109664|NCT01849614|"     The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold     (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast     cancer radiation therapy, can reduce side effects to the heart.   "
109638|NCT01850914|"     Idiopathic normal pressure hydrocephalus (INPH) is a treatable and a common disease of the     elderly. The overall objective of this work is to describe cardio- and cerebrovascular risk     factors and vascular disease in shunted INPH-patients compared to an age- and sex matched     elderly population, as well as the impact of vascular risk factors and vascular co-morbidity     on clinical symptoms and outcome of surgery in INPH-patients. The hypothesis is that     INPH-patients have a higher level of vascular risk factors and subclinical organ damage than     a normal elderly population, and that the higher the level of existing vascular risk factors,     the more severe the symptoms of the hydrocephalic disease.   "
109639|NCT01850901|"     The aim of this study is to assess whether renal denervation (RD) added to usual care     compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP     monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least     135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or     with documented intolerance or contraindication for to 2 or more of the 4 major classes of     antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics)     obstructing use of 3 antihypertensives      Further aims are to assess the effect of renal denervation on the use of BP lowering agents,     to explore the effect of renal denervation in strata of estimated glomerular filtration rate     (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR>60 mL/min per 1.73m2) and according to baseline     office BP.      Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.   "
109640|NCT01850888|"     This is a best available therapy/compassionate use single institution study designed to     determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive     neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher     priority. Patients may receive a range of doses depending on stem cell availability and tumor     involvement of bone marrow. Response rate, toxicity, and time to progression and death will     be evaluated.   "
109641|NCT01850875|"     The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in     non-specific chronic back pain.   "
109642|NCT01850862|"     The investigators hypothesized that an eight-week collective group exercise program would     improve pain, quality of life and functional capacity in patients with knee osteoarthritis     (KOA) compared with those receiving no exercise intervention.   "
109643|NCT01850849|"     The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data     when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic     dermatitis and to healthy subjects.   "
109644|NCT01850836|"     To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic     stimulation (rTMS) on post-stroke non fluent aphasia.   "
133908|NCT01532115|"     The purpose of this study is to evaluate the effect of BIA 9-1067 on the cardiac     repolarization in adult healthy men and women volunteers.   "
109647|NCT01850797|"     The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German multicenter,     prospective, observational registry performed at about 50 study centers covering about 50.000     acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment     will be consecutive. The RASUNOA registry study center is the University Medical Center of     the Principal Investigator (Heidelberg, Germany). The registry will focus on treatment     decisions and concepts in patients being under treatment with a new oral anticoagulant and     suffering from acute ischemic or hemorrhagic stroke.   "
109648|NCT01850784|"     High energy formula more positively affect growth in infants with congenital heart disease     compared to standard formula   "
109649|NCT01850771|"     The primary objective of this study is to compare the improvement in subject-reported     clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar     radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and     durability up to 12 months.      Secondary objectives include incidence of post-operative complications, adverse events,     re-injections, and surgical intervention; change in pain score and use of pain medications.   "
109650|NCT01850758|"     The primary objective of this study is to compare the improvement in subject-reported     clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete,     non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation     of efficacy and durability up to 24 months.      Secondary objectives include evaluation of MRI evidence of tendon repair; incidence of     post-operative complications, adverse events, re-injections, and surgical intervention;     change in pain score and use of pain medications.   "
109665|NCT01849601|"     The purpose of this study is to determine whether the peripheral balloon dilatation catheter     (trade name: Iris) is safe an effective in PTA procedure.   "
112721|NCT01810510|"     The purpose of this study is to determine whether two modes of artificial (i.e. mechanical)     ventilation have an impact on patient synchrony with the ventilator (breathing machine) and     on the patient's work of breathing.   "
109652|NCT01850732|"     The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms     (AAA) among male patients with transient ischemic attack (TIA) symptoms. Ethiology of AAA is     known to be common with atherosclerotic arterial diseases (coronary artery disease,     peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should     be more common among these TIA patients, thus making screening of these patients (for AAA)     more cost-efficient.      Study will be carried out as a prospective screening study. Data will be collected in North     Karelia Central Hospital within one year. All male patients with TIA symptoms will be     recruited for the study and screened for AAA with ultrasound.   "
109653|NCT01850719|"     The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery     and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.      The investigators assume equal improvement of physical function in both groups and reduced     costs with conservative treatment.   "
109654|NCT01850706|"     The purpose of this study is to find a noninvasive test to help physicians diagnose detrusor     overactivity (DO), to use this urine test to help diagnose bladder problems, determine if     treatments are working, and determine if patients are good candidates for interventions like     sacral neuromodulation/Interstim Therapy.   "
109655|NCT01850693|"     This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis     degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with     coronary CT angiography.   "
109656|NCT01850680|"     Primary Objective:      To assess the safety and tolerability of a single dose of subcutaneously administered     sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant     treatment with methotrexate.      Secondary Objective:      To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in     Japanese RA patients.   "
109657|NCT01850667|"     The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic     resection or liver transplantation, but less than 20% of HCC patients are suitable for     surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial     chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete     response and commonly develops recurrence. Recently several small studies reported high tumor     response and local control rate after stereotactic body radiotherapy (SBRT) alone or with     TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable HCC     after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall     response rate of 73% and 2-year local control rate of 95%. They reported severe     gastrointestinal toxicity of 11% because there was no normal tissue constraint for     gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest     levels possible. In addition, they found that the presence of gastroduodenal ulcer before     SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study,     we will conduct a multicenter phase II trial on maintenance of treatment results and     reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply     normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT     to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of     gastrointestinal tract according to gastroduodenal ulcer.   "
109658|NCT01850654|"     The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce     morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying     individuals at high-risk for CRC (genetically predisposed) and providing screening     recommendations for cancer risk reduction, the OCCPI will understand how to increase length     of life and quality of life for those diagnosed with CRC in Ohio, as well as to better     prevent CRC in others in Ohio.      Participants will have free tumor screening for Lynch syndrome, and may be eligible for free     genetic testing and free genetic counseling as part of this study.   "
109659|NCT01849679|"     The investigators hypothesize that aspiration will be more prevalent at two to four hours     post-extubation but will resolve in the majority of patients by 24 to 26 hours     post-extubation.      The purpose of the research is to investigate whether there is a difference in swallow     function two to four hours after extubation (removal of breathing tube) compared to 24 hours     after extubation. This information will help healthcare providers decide if it is necessary     for people to wait 24 hours after extubation before they start eating and drinking.   "
109660|NCT01849666|"     This open-label, multicenter, parallel study will evaluate the effect of multiple doses of     vemurafenib on the pharmacokinetics of a single dose of phenprocoumon in patients with     BRAFV600 mutation-positive metastatic malignancies. Patients will be randomized to receive     either treatment A: a single oral dose of phenprocoumon 6 mg on Day 1 (Eligible patients will     have the option to continue treatment with vemurafenib as part of an extension study     (NCT01739764).), or treatment B: vemurafenib 960 mg orally twice daily on Days 1-29 plus a     single oral dose of phenprocoumon 6 mg on Day 22 (with the option to receive vemurafenib in     the extension study after completion of pharmacokinetic assessments).   "
109661|NCT01849653|"     To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria     gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a     non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a     new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT     (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be     compared to the result obtained with an SOVS collected in the clinic on multiple platforms     (Direct Tube Sampling (DTS) / Panther / Tigris). The term home-collected is used to refer     to any specimen that is not collected in a clinic, since there is no certainty that a     specimen is collected at home or in a restroom in an office setting, etc. To compare the     SOVS results to an FDA cleared predicate test with the collection of two clinician collected     vaginal swabs.   "
109662|NCT01849640|"     This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability     and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or     without single-dose primaquine in patients with uncomplicated Plasmodium falciparum malaria.     On the last day of DP therapy, volunteers will be randomized to receive either a single 45 mg     dose of primaquine (PQ) or DP treatment only (no primaquine).   "
109663|NCT01849627|"     A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g     and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily     energy intake at estimated energy needs for maintenance) on weight loss maintenance.   "
109666|NCT01849588|"     This research study is a Phase IV clinical trial. Phase IV trials are used to further test     and monitor the safety of a drug approved by the FDA and to see if the drug has any other     indications that can be used to treat different diseases.      Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of     liver cancer. It is also currently being tested in various other cancers. Sorafenib works by     slowing down and/or stopping the development of new cancer cells and new blood vessels. By     slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed     that sorafenib prevents or slows down the growth of tumors.      The researchers of this study would like to study the effects of sorafenib on hepatitis C by     drawing additional research blood samples from people infected with hepatitis C who are     receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in     the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.   "
109667|NCT01849575|"     This population based randomized controlled trial (RCT) aims at optimizing cardiovascular     disease (CVD) prevention through accurate identification of individuals at high risk of CVD     and accurate perception of the risk, and better compliance to preventive treatments and     reduced premature CV morbidity and mortality Increased carotid artery intima-media thickness     (CIMT) and carotid plaques, assessed by ultrasonography, are early signs of atherosclerosis     and associated with myocardial infarction and stroke. Few studies have systematically     evaluated image-based risk stratification and its effect on clinical outcomes and results are     conflicting.      The Västerbotten Intervention Programme (VIP), Northern Sweden, is integrated in primary care     services with assessment of traditional CV risk factors and individual health promoting     counseling for all 40-, 50- and 60-year olds (n=6500/yr). Those with diabetes, hypertension,     family history of premature CVD and/or hypercholesterolemia are referred to treatment.      VIP participants with at least one conventional CV risk factor (60% of participants) are     eligible for inclusion in VIPVIZA. During 2013-2015, 3200 participants will be enrolled.     Portable carotid ultrasound machines will be used for ultrasound examinations, whereby CIMT     and plaque formation will be visualized and measured.      Subjects will be randomly assigned to one of two groups; 1/ Intervention: Written information     to patient and physician, including graphic presentation in color of CIMT and of plaque,     vascular age, an ultrasound image, general information about atherosclerosis as a dynamic     process, and recommendation to follow clinical guidelines for risk factor control. 2/     Control: No information from the baseline ultrasonography.      We will explore determinants of behavioral change using psychometric questionnaires and level     of health literacy. Deep interviews at the time point for the ultrasound examinations will     explore how the screening relates to risk perception, quality of life, coping strategies,     attitudes to and skills of self-care.      Both groups will be managed according to clinical guidelines within the usual health care.     After three years (2015-2017), the ultrasonography is repeated and information given to all     participants and their physicians.      CV risk factors, life style and pharmacological treatments will be assessed after one and     three years. CV morbidity and mortality and all-cause mortality will be followed during five     years, i.e. until 2020.   "
109668|NCT01849562|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of     treatment with sovaprevir, ACH-0143102 and ribavirin in GT1, treatment-naive, HCV subjects.   "
109669|NCT01849549|"     Two groups of subjects will be constitute: (i) patients with circumscribed brain injury     (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or     degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.      The objective of this project is to evaluate specific neuropsychological deficits and apply     current brain imaging techniques (anatomical, diffusion, functional) to patients suffering     from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms     underlying these deficits.   "
109670|NCT01849536|"     Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and     progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP     circadian rhythm is altered and varied widely between patients. To date, the only way to     evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour     hospitalization. This method is expensive and does not reflect physiological conditions     because it requires IOP measurements during sleeping periods that may potentially produce     artifacts.      Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour     continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical     device might be influenced by corneal properties of the cornea as central corneal thickness,     keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance, potential     modifications of corneal parameters after a 24-hour wear of the lens, and its influence on     data collected during the whole period of analysis. Then we will also analyze the influence     of corneal parameters on continuous IOP fluctuations measured with the contact sensor and     finally the correlation between data collected and the rate of progression (severity) of     glaucoma evaluated with visual field test or optic nerve head damages.   "
109671|NCT01849523|"     Background Physical as well as psychosocial complaints are frequently present in patients     with a neuroendocrine tumor (NET). Adequate information is seen as an essential aspect of     supportive care. The aim of the current study is to test the effectiveness of a web-based     tailored information and support system targeting patients' information and care needs. Key     features of this system are self-screening of physical and psychosocial problems, tailored     education on reported problems and self-referral to professional health care.      Objective To detect whether a web-based tailored information and support system improves     patients' perception and satisfaction of received information. The investigators hypothesize     that after having received web-based tailored information and support patients feel more     informed and are more satisfied with the received information than when receiving standard     care.      Study design The present study is a randomized prospective longitudinal experimental     multicenter pilot study. In this study, we want to examine the effect sizes on the perception     and satisfaction by the patient of received information (primary objective) and secondary     objectives after having used web-based tailored information and support. Eligible are newly     diagnosed NET-patients (N=40) (diagnosed less than 3 months ago). Patients will be asked to     fill out questionnaires at baseline and after 12 weeks, on socio-demographic features (only     at baseline), internet use (only at baseline), health care use, patients' perception and     satisfaction of received information, distress, quality of life and empowerment (only after     12 weeks).      Study population Patients diagnosed with a NET (any type of NET, any phase of disease) who     are under treatment at the Department of Medical Oncology in the University Medical Center     Groningen or Hospital Medisch Spectrum; twenty will be invited to participate in the study.      Intervention During 12 subsequent weeks, a personalized website (with a surname/password)     will become available to patients in the experimental group beside the usual standard care.     Key features of the website are self-screening, tailored patient education and self-referral.     Self-screening will be performed by an online version of the Dutch Distress thermometer (DT)     and Problem List (PL). Patients will receive automated feedback on their DT score immediately     after test completion together with information regarding problems reported on the PL,     options for (self)-help and possibilities for referral to professional care. Contact     information will also be available to discuss questions, problems and/or referral needs.     Patients may also request a telephone call.      Main study endpoint The primary endpoint is to detect an improvement in patients' perception     and satisfaction of received information after having received web-based tailored information     and support.   "
109687|NCT01850472|"     The purpose of this research study is to investigate how the brain processes emotions, and     the way these processes affect behavior. Specifically, we hypothesize that individual     differences in reward responsiveness will correlate with differential activation in     mesolimbic regions of the brain and predict future wellbeing in follow-up interviews.   "
109688|NCT01850459|"     The purpose of this research study is to establish a way to help the development of targeted     treatments in autism spectrum disorders. This may also help in early diagnosis of autism and     may possibly predict severity. The study will compare subject's ERK (extracellular     signal-related kinase) signaling to age- and gender-matched neurotypical controls and     Intelligence quotient (IQ)-matched developmental disabilities.   "
109672|NCT01849510|"     Spinal metastases indicate for an incurable course of disease. Local tumor control after     palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of     patients, therapy fails locally within two years associated with further symptoms that are     difficult to treat, because a further radiation of already radiated vertebra leads to a     higher rate of myelitis. This trial aims to improve local tumor control and control of pain     by radiotherapy with increase in total and single dose. Dose elevation is realized by     simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT &     hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy).     Primary endpoint is local tumor control (time up to progression). Secondary endpoints are     pain control associated with quality of live, severity of acute and chronic adverse effects     and overall survival. It is planned to recruit a total number of 155 patients.   "
109673|NCT01849497|"     The primary objective of this study was to assess users' ability to administer a full dose of     evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.   "
109674|NCT01850641|"     The purpose of this study is to investigate the safety and efficacy when administering PA21     with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.   "
109675|NCT01850628|"     This study is a biospecimen discovery project that will serve as a pilot for a comprehensive     'omics approach using fresh core biopsy tissue and blood samples for DNA and protein     analysis, as well as paired tumor-normal exome DNA and RNA sequencing.   "
109676|NCT01850615|"     This trial is conducted in Asia, Europe, South America, and the United States of America     (USA).      The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen     versus basal insulin therapy, both in combination with metformin in adult subjects with type     2 diabetes.   "
109677|NCT01850602|"     The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis     patients with hyperphosphatemia   "
109678|NCT01850589|"     The aim of this study is to prove that the use of Bupropion with counseling works better than     counseling alone for patients to quit smoking. The belief is that overall, there is a small     percentage of patients who quit smoking all together.   "
109679|NCT01850576|"     Public health programs and policies have utilized the combination prevention model of     bringing together tailored, proven interventions in order to reduce the global impact of HIV.     Project TEACH-Kenya adapts two effective HIV interventions, Project BRIEF (Behavioral     intervention, Rapid HIV test, Innovative video, Efficient cost and health care savings,     Facilitated seamless care) and STEP (Skill-based Teenage Education Program for HIV     prevention) to increase HIV testing and counseling rates, implement proven risk reduction     programs, and improve rates of linkage to care and ART initiation among adolescents in Kenya.     The collaboration with St. Francis Community Hospital and input from the Kasarani community     will increase the breadth, reach, and impact of this HIV prevention intervention in Kenya.   "
109680|NCT01850563|"     Patients with brain metastases who are candidates for treatment with stereotactic     radiosurgery (SRS) are potential study participants. SRS delivers high-energy,     precisely-focused radiation to each brain metastasis to shrink the tumor, and is the     standard-of-care for patients with these tumors. Oxygen enhances the damaging effects of     radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all     kinds of tissues, including tumors. The purpose of this trial is to study whether it is     feasible to treat patients with HBO just prior to receiving SRS, given the timing constraints     of treating sequentially with HBO and then SRS. Patients will undergo HBO treatment followed     by the placement of a Gill-Thomas-Cosman head frame then transported ,via stretcher, to     receive SRS. The transfer and placement of the head frame needs to be completed within the     15minute time frame. The trial's secondary objectives are to determine whether it has any     effects on outcomes and quality of life. As part of study participation patients will be     asked to complete quality of life questionnaires as well as mini mental status     questionnaires. These will be done prior to treatment and at follow up appointments     throughout the next 3 years while participating in the study. Patients will be given the     option to participate in the optional bio marker blood draw study which would require     patients to have blood drawn at three time points, pre-treatment, the day after treatment and     at their first follow up visit.   "
109681|NCT01850550|"     The specific objective of this research proposal is to determine the short-term efficacy of a     primary care-based weight control intervention in which successful volunteer peers deliver a     group-based program.      The purpose of the study is to conduct a pilot randomized controlled trial (RCT) of a     successful volunteer peer-led weight control program compared to a control condition to     determine intervention efficacy at 3 months. Six peer leaders from 2 primary care clinics     will be recruited and trained to conduct the intervention. Overweight and obese patients     (n=80) will be recruited (randomized by individual) to determine weight loss at 3 months     (primary outcome). The program consists of 12 weekly weight loss sessions led by a successful     volunteer peer leader using an adaptation of the Diabetes Prevention Program to help     participants lose weight.   "
109682|NCT01850537|"     This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is     to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar     Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic     degenerative disc disease (DDD).   "
109683|NCT01850524|"     This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and     efficacy of IXAZOMIB versus placebo when added to lenalidomide and dexamethasone (LenDex) in     patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell     transplant.   "
109684|NCT01850511|"     Nasal obstruction is a common complaint prompting presentation to an otolaryngologist. Many     studies have been performed quantifying and describing the impact of a number of factors on     symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and inflammatory     causes. Despite this scrutiny, no attention has been paid to the nasal vibrissae as a     potential anatomical contributor to nasal obstruction. The proposed study intends to     elucidate that contribution, if any exists.   "
109685|NCT01850498|"     Evaluate patient motion during seizures.   "
109686|NCT01850485|"     The hypothesis is: In patients after an out of hospital cardiac arrest, treated with     therapeutic hypothermia (33°C) will be found significantly more microcirculatory     abnormalities, compared to the same group of patients treated with 36°C.   "
109693|NCT01850394|"     The purpose of this study is to determine 1) the effective dosage of intra-articular     tranexamic acid injection for controlling blood loss and blood transfusion requirement in     conventional total knee replacement, and 2) whether the blood loss reduction effect depended     on the dose of tranexamic acid used.   "
109694|NCT01850381|"     GM608 is an endogenous human embryonic stage neural regulatory and signaling peptide that     controls the development, monitoring and correction of the human nervous system. The study     drug is an oligopeptide with a sequence identical to one of the active sites of human     Motoneuronotrophic Factor and is manufactured by solid phase synthesis. Preclinical research     indicates it to be a neuro-protective agent in animal models of PD, other neuro-degenerative     diseases and stroke. This trial is designed to test proof of principle, i.e. determine if a     2-week treatment with this agent can restore the non-functioning nigral dopaminergic neurons     in PD over a 3 month period, during which the placebo-treated arm is expected to have little     or no worsening of the total UPDRS (Unified Parkinson's Disease Rating Scale)score compared     to baseline.      Study Objectives are:        1. To compare the safety and tolerability of GM608 with placebo in a population of patients          with early PD.        2. To field test the study procedures for feasibility and efficiency        3. To determine if there is any hint that injections of GM608 might slow the rate of          clinical worsening of PD.   "
109695|NCT01850368|"     Recently, several studies reported promising outcomes of patients after external beam     radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis.     However, conventional EBRT is composed of many fractions (20-35 fractions). On the other     hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a     high dose of radiation to the target using a few fractions with a high precision within body.     SABR increases radiation biologic effect for tumor, makes patients more comfortable due to     reduction of the number of hospital visit, and enables patients to receive another treatment     more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with     major portal vein tumor thrombosis.   "
109696|NCT01850355|"     The main objective of this exploratory 8-week pilot study is to evaluate the safety and     efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism     spectrum disorders. The study results will be used to generate hypothesis for a larger     randomized controlled clinical trials with explicit hypotheses and sufficient statistical     power.   "
109697|NCT01850342|"     Autologous washed and homogenized fat micrograft harvested from the patient's front abdominal     wall enriched with adipose-derived regenerative cells (ADRC) derived by enzyme-treatment of a     portion of the harvested fat. Fat tissue micrograft mixed with ADRC will be administered     one-time endoscopically into submucosal layer of urethra under eye control. This is a single     arm study with no control. All patients receive cell therapy.   "
109698|NCT01850329|"     This study is planning to develop the computed-assisted information program and determine     whether the computed-assisted information program are superior to routine discussion for     informing parents in the emergency department (ED) about risks, benefits, and alternatives to     receiving procedural sedation for their children.   "
109699|NCT01850316|"     Respiratory-gated, volumetric-modulated arc therapy will be used for the clinical development     of high dose rate Stereotactic Body Radiotherapy (SBRT) in inoperable hepatocellular     carcinoma (HCC). These treatments should enhance local control, progression-free survival and     potentially overall survival in HCC patients. The investigators will also examine the     mechanism of tumour and microenvironmental response to high dose radiation, and search for     potential biomarkers to optimize and individualize therapy. Pre-treatment and follow-up     PET/CT imaging with 11C-choline, 18F-fluorodeoxyglucose (FDG) and CT perfusion will examine     in-vivo changes in proliferation, glycolysis, and the tumour vasculature, respectively, and     blood samples will look for immunologic biomarkers of tumour response.   "
109982|NCT01846390|"     This research is being done because it is not yet known what dose of romidepsin in     combination with gemcitabine, dexamethasone, and cisplatin (GDP) can be given safely to     patients with peripheral T-cell lymphoma, nor what type and severity of side effects will     result from the combination of these treatments. This research is also being done because it     is not clear if the addition of the new drug romidepsin to treatment with GDP can offer     better results and longer survival.   "
109700|NCT01850303|"     For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but     IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is     better than monotherapy in term of overall survival and progression free survival. The     current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles).     After the treatment is stopped until progression and initiation of a second line treatment.     The risk of this strategy is to be confronted to a rapid disease progression during the free     interval. Indeed, about 1/3 of the patients whose disease was controlled after the     chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous     therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of     1st line (induction chemotherapy).      There is two types of maintenance :        -  continuous maintenance therapy which consists in continuing the treatment initially          associated with platinum until disease progression.        -  switch maintenance which consists in introducing a new treatment after the end of          induction chemotherapy The two types are validated by several trials. The marketing          authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.      Gemcitabine has a good tolerance profile which make possible the use in a maintenance     strategy. Several trials evaluated maintenance with this product and some show benefits in     term of progression free survival.      The objective of this trial is to evaluate the switch maintenance in elderly patient with a     controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.   "
109701|NCT01850290|"     This study will examine resting dopamine function as well as dopamine response in the brain     as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI)     patients.   "
109702|NCT01850277|"     The purpose of this prospective randomized study is to determine whether patients on cardiac     resynchronization therapy with concomitant long-standing persistent or permanent atrial     fibrillation would benefit from a strategy to restore and maintain sinus rhythm (rhythm     control strategy) in comparison to a rate control strategy in terms of higher biventricular     paced beats percentage.   "
109703|NCT01850264|"     Primary objective of this study is to evaluate whether the use of a quadripolar left     ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower     non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)   "
110313|NCT01842074|"     The investigators plan to study the role of bortezomib for desensitizing patients awaiting a     living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA)     Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4     hospital in FRANCE.   "
109704|NCT01850251|"     The purpose of this study is to determine whether a nutritional supplement high in protein     and energy, and enriched with hydroxymethylbutyrate (HMB) and vitamin D is more effective     than a standard nutritional supplement high in protein and energy in improving muscle     strength in elderly patients with hip fracture.   "
109705|NCT01850238|"     This first-time-in-man study is mainly designed to assess the safety and tolerability of     AADvac1 in the treatment of Alzheimer's disease.      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is     the main constituent of neurofibrillary tangles (NFTs), and is intended to be a     disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.      As this study is a Phase I study focused on tolerability and safety, efficacy will be     assessed in an exploratory manner.   "
109706|NCT01850225|"     Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear     anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An     auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the     brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not     demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1     year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study     to determine the safety of the ABI.   "
109707|NCT01850212|"     A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year     old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate     (TDF)-based regimen   "
109708|NCT01850199|"     Gestational diabetes, diabetes diagnosed during pregnancy, affects 8.8% of pregnancies in     Spain that means more than 40,000 women per year. This prevalence is based on the National     Diabetes Data Group criteria, previous to the 4th workshop on Gestational Diabetes (1998),     but, if the new diagnosis criteria proposed by the International Associations of Diabetes and     Pregnancy Study Groups, based on the most important study never made before on this topic,     prevalence would increase to the double. When a women is diagnosed, the risk of complications     for her and the child increases and, therefore, she has to start an specific diet and     frequent visits to the diabetes center in order to check that glucose values do not exceed 95     mg/dl before or 140 mg/dl 1-hour after meals. In other case, she should start insulin     treatment. Our project is aimed to develop intelligent tools based on neuro-diffuse     techniques and integrated in a telemedicine system that allows control of gestational     diabetes automatically, guaranteeing glucose control objectives consecution and avoiding     face-to-face visits to the health care center. Furthermore, educational and motivation tools     for a healthy behaviour will be included. At the end of the study efficacy and security about     insulin management will be compare with the recommendations proposed by the diabetes team and     data about direct and indirect costs will be calculated. The investigators anticipate that     the smart telemedicine system can allow us to detect high blood glucose values earlier than     in-person scheduled visits.   "
109729|NCT01849926|"     Although uncomplicated cystitis is considered to be a mild condition and mostly self     limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are     known to give a quick relief of symptoms and shorten the course of the condition by a few     days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of     uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see     whether symptomatic treatment with ibuprofen is equally efficient as treatment with     mecillinam in this group.   "
109730|NCT01849913|"     The aim of the proposed study is to investigate the effects of low-level laser therapy on     neck pain.   "
114524|NCT01786798|"     The objective of this study is to investigate the role of transvaginal ultrasound in     detecting endometrial hyperplasia and endometrial cancer in women aged more than 35     presenting with abnormal uterine bleeding.   "
109709|NCT01850186|"     Recent data highlight the role of vascularity in melasma and a recent study showed the     interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a     copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser can     target both the vascular and pigmented components of melasma. A preliminary study has shown     its efficacy and excellent tolerability in the treatment of melasma. This study requires     however to be confirmed by a comparative study versus reference treatment.      Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow     Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in an     intra-patient study.      Secondary objectives        -  To study the frequency of PPI.        -  Compare the rate and extent of recurrence 6 months after completion of treatment.        -  To study the occurrence of possible adverse effects.        -  Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end          of treatment).        -  To study patient satisfaction on the effectiveness and tolerability of the study          treatments.      Methods Monocentric prospective interventional randomized split face comparative study     between experimental treatment versus reference treatment.      Intervention        1. Visit Selection Patients will be selected from those presenting to the consultation of          the department of dermatology at University Hospital of Nice. Participation will be          offered to patients corresponding to the selection criteria of the study.        2. Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin          the study. This will ensure that patients signed informed consent. An initial clinical          evaluation of melasma with calculation of MASI score and standardized photographs (see          chapter 'assessment') will be made. An examination by confocal microscopy in vivo will          be realized. All patients will receive treatment by stabilized kilnman trio for four          weeks.           In the week prior to Visit 1, the side of the face to receive the laser treatment will          be determined by randomisation.        3. Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and          photographs will be made. Possible side effects (including PPI) will be noted.           The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The          contralateral side will receive its first laser session. Given the results of analysis          by intention to treat, the occurrence of serious side effects will result in          discontinuation of treatment but monitoring will continue with the assessments.        4. Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and          photographs will be made. Possible side effects (including PPI) will be noted.           The laser side will receive its second session. Patients continue the applications of          cream on the contralateral side.        5. Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and          photographs will be made. Possible side effects (including PPI) will be noted.           The laser side will receive its third session.Patients continue the applications of          cream on the contralateral side.        6. Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and          photographs will be made. Possible side effects (including PPI) will be noted.           The laser side will receive its fourth and final session. Patients continue the          applications of cream on the contralateral side during 4 weeks.        7. Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and          photographs will be made. Possible side effects (including PPI) will be noted. An          assessment by in vivo confocal laser will be realized.        8. Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and          photographs will be made. Possible side effects (including PPI) will be noted. An          assessment by in vivo confocal laser will be realized.        9. Visit V7 (final week 36):      Clinical evaluation of melasma with calculation of MASI score and photographs will be made.     Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser     will be realized. The evaluation of safety and patient satisfaction will be performed using a     visual analog scale.      The primary endpoint will be the MASI score, score approved for assessment of melasma     treatments.   "
109710|NCT01850173|"     The investigators designed the current study with the main objective of determining whether     Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the     functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD)     patients referred to a rehabilitation programme.   "
109711|NCT01850160|"     This trial is aimed to assess the efficacy and safety of a fixed-dose combination therapy     with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone alone for treatment of     adult patients with diagnosis of arterial hypertension.   "
109712|NCT01850147|"     The purpose of this study is to determine whether sequential application of low-dose     short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung     cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.   "
109713|NCT01850134|"     The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.   "
109714|NCT01850121|"     The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg     every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether     IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year     sustained the treatment effect. The study was started in 2003 an finished in 2008.   "
109755|NCT01849393|"     The primary objective of this project is to assess the study population's acceptance of two     medication adherence support strategies: incentive-based programs and electronic medication     monitoring. The study population is adolescents (ages 16 - 24) positive for human     immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St.     Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio     Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be     10-20 minutes. Patient identifiers will not be attached the survey.   "
109715|NCT01850108|"     Allogeneic blood or marrow transplantation (alloBMT) is a curative therapy for a variety of     hematologic disorders, including sickle cell disease and thalassemia. Even when it is clear     that alloBMT can give to these patients an improvement in their disease, myeloablative     transplants have important toxicities and mortalities associated. The lack of suitable donors     continues to be a limit to access to transplantation. Substantial progress has been made     recently in the development of pre-treatment regimens that facilitate the sustained     engraftment of donor marrow with reduced toxicity. Most of these regimens incorporate highly     immunosuppressive drugs, which allow the reduction or elimination of myeloablative agents or     total body irradiation without endangering the sustained engraftment of HLA-identical     allogeneic stem cells. Preliminary results of non-myeloablative allogeneic stem cell     transplantation suggest that the procedure can be performed in patients who are ineligible     for myeloablative alloBMT, and that sustained remissions of several hematologic malignancies     can be obtained.   "
109716|NCT01850095|"     Acne vulgaris is a chronic inflammatory disease that affects the pilosebaceous unit. Recent     studies have demonstrated an increase number of acne cases in adult women. These cases are     predominantly normoandrogenic and have some clinical differences when compared with the most     common group, the adolescent. The local glandular metabolism converts some hormonal     precursors to more active substances that increase the sebum production, leaving these areas     more prone to increase the colonization to Propionibacterium Acnes (P. Acnes). Toll-like     receptor 2, expressed by inflammatory cells play a crucial role in the innate immune response     to this bacterium. Previous studies confirm that exist a reduced expression of CD1d by     keratinocytes in acne lesion, what can be interpreted as a low antigen-present function. The     influence of hormonal alteration in the sebaceous glands could modulate the expressions of     TLR-2 and CD1d explaining the persistence of lesions in adult women. The change to more     estrogenic metabolism, with use of specific contraceptive pills could normalize this     immune-mediated inflammatory process.      Objective      To analyze how the peripheral androgen conversion can influence the toll-like receptor 2 and     CD1d expression in women with inflammatory acne before and after 6 months of oral     contraceptives with anti-androgen activity.   "
109731|NCT01849900|"     This study examines the efficacy of the Preconception Reproductive Knowledge Promotion     (PREKNOP) intervention, designed to promote women's reproductive health and positive     pregnancy outcomes. The study's goal is to educate low-income women about reproductive     changes related to their menstrual cycle. The main hypothesis of the study is that women who     receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and     increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning     ability.   "
110448|NCT01840319|"     The goal of this retrospective observational study is to collect only status survival data 30     days after the last dose of treatment of patients included in the initial protocol WYETH     3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the     last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.   "
109717|NCT01850082|"     Coronary artery bypass grafting (CABG) is the most common major surgical procedure in the     United States with over 300,000 cases performed each year. To restore blood flow to the     heart, vascular conduits from another part of the body are procured to create a bypass around     critically blocked coronary arteries. The left internal thoracic artery is the conduit of     choice for CABG due to its superior long-term patency. However, almost all patients referred     for CABG require additional grafts to provide complete revascularization. This necessitates     the harvest of other vessels, most commonly the saphenous vein which is used almost     ubiquitously in contemporary CABG with an average of two vein grafts per CABG procedure. In     the last 10 years, Endoscopic Vein Harvesting (EVH) has been recommended as the preferred     method over the traditional open harvesting technique (OVH) because it provides a minimally     invasive approach. However, more recent investigations indicate potential for reduced     long-term bypass graft patency and worse clinical outcomes with EVH. The long term impact of     EVH on clinical outcomes has never been investigated on a large scale using a definitive,     adequately powered, prospective Randomized Controlled Trial (RCT) with long-term follow-up.   "
109718|NCT01850069|"     The aim of this study is to determine whether we can predict the intracranial pressure using     near infra-red spectroscopy   "
109719|NCT01850056|"     The purpose of this study is to determine whether DEB is more effective than common PTA     balloon in long-term vessel patency and inhibiting restenosis.   "
109720|NCT01850043|"     TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC     recommendation. Participants with chest radiograph showing active TB lesion are excluded from     this study.   "
109721|NCT01850030|"     Female inability to conceive a child. The purpose of this randomized, two-arm and     double-blind study is to demonstrate that the treatment of a daily dose of 3x10mg     dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized     progesterone capsules administered intravaginally for the luteal support in patients     undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until     pregnancy is negative or until week 12 gestation.Patients will be followed during treatment     until 30 days after delivery to record any safety and tolerability data of the patient and     their newborn(s).   "
109722|NCT01850017|"     The investigators will conduct a prospective randomized double blind study comparing     methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in     two randomized groups. The investigators plan to document the intraoperative opioid     requirements, time to first dose of opioids postoperatively and total opioid consumption in     the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be     assessed.   "
109723|NCT01850004|"     The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia     (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib     treatment are able to maintain a sustained remission in the long-term, with undetectable or     minimally detectable BCR-ABL residual disease.   "
109724|NCT01849991|"     This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with     colic. The study is being conducted in order to prove treatment dose with probiotic     (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.   "
109725|NCT01849978|"     This study will examine whether or not providing early stage breast cancer survivors with     tips on making exercise more enjoyable promotes greater levels of moderate to strenuous     exercise.   "
109726|NCT01849965|"     To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound     closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active     ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM)     who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.   "
109849|NCT01848145|"     This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated     infusion schedule of ofatumumab in patients who have received at least one prior therapy for     CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion     number 3 (2000 mg) within 15 minutes of the planned time.   "
109727|NCT01849952|"     MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes.     Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas,     known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b     (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue.     This study tests the hypothesis that in primary glioma samples mir-10b expression patterns     will serve as a prognostic and diagnostic marker. This study will also characterize the     phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the     critical function of anti-mir-10b in blocking established glioblastoma growth, the     investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b     treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from patients     diagnosed with gliomas over a period of two years. These samples will be examined for mir-10b     expression levels. Patient survival, as well as tumor grade and genotypic variations will be     correlated to mir-10b expression levels.   "
109728|NCT01849939|"     Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However, the     diagnosis in young patients become more frequently with poor prognosis. The identification of     new prognostic factors permits early determination of the high risk population and provide     them the therapeutic intensification. Allogeneic transplantation of hematopoietic stem cells     transplantation (AHSCT) allows to long-term remission and in some cases complete and     definitive eradication of the disease. After chemotherapy or antibodies, the Minimal Residual     Disease (MRD) negativity is associated with better disease-free survival. MRD negativity     occurs in some patients with the appearance of GVHD, stopping the immunosuppression or after     donor lymphocyte injection (DLI). The negativity of MRD in the first year post-transplant is     correlated with better progression-free survival or overall survival (Dreger 2010, Farina     2009, Caballero 2005, Algrin, 2011). So, MRD negativity may be an objective after AHSCT. The     aim of this prospective study is to evaluate a standardized preemptive immunointervention of     post-allograft immunosuppressive therapy modulation and DLI administration according to MRD     level. The objective is to obtain MRD negativity at 12 months after AHSCT.   "
116086|NCT01766388|"     The primary goal of this study is to examine the efficacy and feasibility of a mifepristone     combined with misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in     Armenia.   "
109732|NCT01849887|"     Stroke is a major cause of adult disability. Currently approved reperfusion therapies are     provided to only a small percentage of patients in the U.S. New therapies are needed that     improve outcome and that can be accessed by a majority of patients. Animal studies suggest     that bone marrow-derived mesenchymal stem cells, administered intravenously days after a     stroke, safely improve long-term behavioral outcome. A large human experience suggests the     safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to     assess the safety of this therapy in patients with recent ischemic stroke.   "
109733|NCT01849874|"     The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during     which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary,     fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or     a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan).     Patients will be followed to compare the effectiveness of the study drug to that of the     selected chemotherapies. Patients may be eligible to crossover from physician's choice     chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed     disease progression. Approximately 360 patients from North America, Europe and Australia will     be enrolled in this study.   "
109734|NCT01849861|"     The purpose of this study is to correlate in an elderly population (≥ 65 years), the     different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive     symptoms and cognition. And assess whether the increased serum TSH to the upper half of the     normal range, through the use of antithyroid drugs, is associated with improvements in these     parameters.   "
109735|NCT01849848|"     The purpose of this study is to determine the antitumor efficacy and safety of bendamustine     (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration     for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory     multiple myeloma.   "
109736|NCT01849835|"     The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal     and trans-perineal) to perform prostate biopsy from the rate of Positive detection,     complications, pain level, operation time and costs et al.   "
109756|NCT01849380|"     S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine     drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and     1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal     toxicity. Several studies have proved the safety and efficacy of single agent S-1 in     metastatic breast cancer. This study is designed to further investigate and compare the     efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs.     Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with     local advanced breast cancer.   "
109757|NCT01849367|"     Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression     that has shown promising efficacy in four recent double-blind, randomized, sham-controlled     trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be     measured during the trial.   "
109737|NCT01849822|"     This research study is being done to develop a brain controlled medical device, called a     brain-machine interface or BMI, that will provide people with a spinal cord injury some     ability to control an external device such as a computer cursor or robotic limb by using     their thoughts.      Developing a brain-machine interface (BMI) is very difficult and currently only limited     technology exists in this area of neuroscience. The device in this study involves implanting     very fine recording electrodes into areas of the brain that are known to create arm movement     plans and provide hand grasping information. These movement and grasp plans would then     normally be sent to other regions of the brain to execute the actual movements. By tying into     those pathways and sending the movement plan signals to a computer instead, the investigators     can translate the movement plans into actual movements by a computer cursor or robotic limb.      The device being used in this study is called the NeuroPort Array and is surgically implanted     in the brain. This device and the implantation procedure are experimental which means that it     has not been approved by the Food and Drug Administration (FDA). One NeuroPort Array consists     of a small grid of electrodes that will be implanted in brain tissue with a small cable that     runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed     to be attached to the skull and protrude though the scalp to allow for connection with the     computer equipment.      The investigators hope to learn how safe and effective the NeuroPort Array is in controlling     computer generated images and real world objects, such as a robotic arm, using imagined     movements of the arms and hands. To accomplish this goal, two NeuroPort Arrays will be used.   "
109738|NCT01849809|"     A research study of the effectiveness and safety of gamma knife ventral capsulotomy in     patients with severe intractable obsessive-compulsive disorder (OCD).   "
109739|NCT01849796|"     A study to determine if transcranial direct current stimulation (tDCS, the device that     regulates brain activity, can improve pain in people with neuropathic facial pain and compare     which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the     motor cortex) can result in better pain-relief.)   "
109740|NCT01849783|"     This phase II trial investigates whether patients greater than or equal to 65 years of age     diagnosed with myeloma or another plasma cell malignancy will have better outcomes with     transplant followed by maintenance therapy, as primarily measured by progression-free     survival, versus non-transplant approaches.   "
109741|NCT01849770|"     The purpose of this research is to find out if mexiletine is safe and effective in people     with Amyotrophic Lateral Sclerosis (ALS). In this trial, participants will be taking either     300 milligrams per day of mexiletine, 900 milligrams per day of mexiletine or placebo     (non-active study drug). The safety and efficacy of these doses will be compared to see if     one dose is better than the other.   "
109742|NCT01849757|"     The purpose of the study is to determine which priming fluid is the safest for use for     priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing     cardiac surgery. The fluids to be compared are albumin and voluven. A control group will     receive only crystalloid.   "
110474|NCT01839981|"     This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with     locally advanced or metastatic pancreatic cancer. Drugs used in chemotherapy, such as     6,8-bis(benzylthio)octanoic acid, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing.   "
109743|NCT01849744|"     This is a Phase I, open-label, multicenter, dose-escalation trial of VS-4718, a focal     adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. This     clinical study is comprised of 2 parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The     purpose of this study is to evaluate the safety (including the recommended Phase II dose),     pharmacokinetics (the amount of VS-4718 in your blood) and the anti-cancer activity of     VS-4718. The pharmacodynamic effects (genes or proteins that may predict or show how your     body may respond to VS-4718) will also be examined in tumor biopsies and blood samples.   "
109744|NCT01849731|"     The purpose of this cluster randomized trial is to determine whether an intervention     implemented in a General Surgery, based in improving patient-provider communication, results     in a better diabetes self-management in patients with lower educational level. A secondary     objective is to assess whether telephone reinforcement enhances the effect of such     intervention.   "
109745|NCT01849718|"     This research project deals with stress treatment in the form of garden therapy in the     therapy garden Nacadia. The therapy Garden Nacadia has an evidence-based design that is     specially designed for the treatment of stressed people.      Nacadia-therapy can be described as a process in which the patient's health and well-being is     assumed to enhance by the presence of the natural environment and through participating in     meaningful gardening activities.      NEST concerns research on the effect of Nacadia-therapy. The study consists of randomized and     longitudinal studies of the effects of Nacadia-therapy compared to acknowledged cognitive     behavioral therapy (CBT).      The outcome measures for example consist of: ability to return to work, health care use,     psychological measurements related to stress, health, quality of life and changes in     medication use. Further, exploratory studies of the garden therapy in the form of     observations and interviews will be performed, to get a better understanding of the garden     and the garden activities' importance for the therapeutic purposes.      Hypothesis:      - garden therapy, in a designed natural environment, will lead to improved health and     well-being for people who are off sick with stress-related disorders   "
109746|NCT01849705|"     Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic     obesity, and can explain 2-6% of severe obesity.      Studies have shown that mutations in MC4R are associated with increased fat mass,     height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R     are less penetrant for these phenotypes but it has been observed that individuals with MC4R     mutations have a smaller than expected blood pressure for their degree of obesity.      The purpose of this study is to explore the association between functional MC4R mutations and     obesity, insulin resistance and blood pressure.   "
109747|NCT01849692|"     The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a     microvolume injection or infusion on retinal function and morphology in subjects with     exudative age-related macular degeneration (AMD).   "
109874|NCT01847807|"     Metabolic syndrome have the damages on tissues and organs in heart、kindey and vessels. In     this study, prospective randomized, controlled, parallel designed ,different doses of     Astragalus Mongolia, Gansu Longxi produce treat on the MS patients, and then use real-time     quantitative PCR and Western Blotting to detect the index of oxidative stress     、angiotensin-converting enzyme 2 mRNA expression and proteins.   "
109748|NCT01849484|"     This randomized trial examines possible enhancements in live quality and neurocognitive     functions in patients after radiotherapy of the neurocranial area with hippocampal sparing.     Although the hippocampus has a crucial role in regard to neurocognition and memory,     hippocampal region has been relatively disregarded in radiotherapy of neurocranium so far.     Brain metastases in the hippocampal region are very rare and an infiltration of the     hippocampus by meningioma or by pituitary adenoma just occurs when volume of the tumor is     very high. This study aims to reduce the radiation dose in the hippocampal region to improve     the quality of live and neurocognitive functions in patients without degrading prognosis or     increasing probability of brain metastases in hippocampal region.      Primary endpoint of the trial is quality of live and neurocognitive functions in patients     after radiation of neurocranial region with hippocampal sparing compared with conventional     radiotherapy of the neurocranial region without hippocampal sparing. Secondary endpoints are     cerebral recurrence rate in hippocampal region and overall survival. It is planned to include     a total number of 150 patients.   "
109749|NCT01849471|"     This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic     effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous     and interstitial radiotherapy are included. Beside medical effects and adverse events, it's     prospectively needed to extensively inform patients about socioeconomic aspects associated     with radiotherapy. The interrogation comprises to collect possible costs and expenditures     during and after therapy. Aspects especially concerning post therapy period include     additional consultations, individual applied alternative medical care, need for additional     medical aids (salves, medicine, bandages) and changes in professional and social situation.     It's figured out in what extend costs are absorbed by health insurance coverage. In Germany     there is no appropriate trial with respective patient population and respective therapy.     Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as     changes in social and professional situation. Secondary endpoints are quality of life,     adverse events of therapy and the correlation of quality of life, adverse events and economic     aspects for the patient and the health insurance coverage.   "
109750|NCT01849458|"     The aim of this study is to collect and report data from a consecutive series of patients     implanted with these products as part of a post-market surveillance plan for CE Mark approval     in the European Union.   "
109751|NCT01849445|"     The TRIO-physio study is looking at how well patients with osteoarthritis recover after knee     replacement surgery (also known as Total Knee Arthroplasty (TKA)). Currently around 20% of     patients are not satisfied after TKA. This project will look to find out if the research team     can identify patients who will not recover well at an earlier stage, so that these patients     can be helped sooner.      The study will try to determine if doing intense physiotherapy with patients who are not     doing well at the first review (6 weeks after their operation) can improve how well they have     recovered at one year.   "
110475|NCT01839968|"     The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to     reverse the antiplatelet effects of prasugrel.   "
109752|NCT01849432|"     A diverse body of research has implicated the amygdalo-cortical circuitry in the     pathophysiology of anxiety disorders. For example, one model of PTSD posits exaggerated     amygdala responsivity to threat-related stimuli as well as deficient top-down modulation of     amygdala responses by specific cortical regions, including the pregenual anterior cingulate     cortex, subcallosal cortex, and hippocampus.      The investigators propose to investigate the pathophysiology of several specific anxiety     disorders, Posttraumatic Stress Disorder (PTSD), Panic Disorder (PD), and Specific     Phobia(SP), by using cognitive activation paradigms and magnetic resonance imaging (MRI) to     probe the function and structure of implicated amygdalo-cortical circuitry.   "
109753|NCT01849419|"     The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine     (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely     used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With     this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory     animals, the public health implications of ecstasy use may be substantial. Certain subjective     effects of this drug distinguish it from other stimulants, and may contribute to its     widespread use: That is, users report that ecstasy produces profound feelings of empathy and     closeness to others. These so-called 'empathogenic' effects, which may reflect the     distinctive neurochemical profile of action of the drug, have yet to be characterized in     controlled laboratory studies. The investigators propose to characterize the effects of MDMA     on measures of social and emotional processing that may contribute to this 'empathogenic'     profile, including measures of emotion recognition, emotional responsiveness and sociability.     The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active     control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin     will be used because it appears to produce pro-social behavioral effects resembling those     attributed to MDMA.   "
109754|NCT01849406|"     It is anecdotally well known that patients snore more when their nose is blocked. However,     the therapeutic effect of improving nasal airway patency on snoring indices remains a point     of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and failed     to show any improvement in the number of snores after its application, although     apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that     dilation of the anterior nares in patients without nasal pathology has a relatively weak     effect on snoring, and routine use of nasal dilating appliances was not recommended for the     treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids     have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep apnea     (OSA) implying that there might be an equivalent result for the use of nasal steroids on     snoring indices.      Additionally, the present authors have demonstrated a strong correlation between     apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal     nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively     have decreased nasal breathing epochs.      It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might     be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal     steroids might also increase nasal breathing epochs and lead to decreased snoring indices in     patients who had decreased nasal breathing before the administration of nasal steroids.      Patients will be randomized in two groups: the patients of the first group will undergo a one     week therapy of nasal budesonide, then two weeks of washout period, and thereafter one week     of nasal normal saline. The patients of the second group will undergo a one week therapy of     nasal normal saline, then two weeks of washout period, and thereafter one week of nasal     budesonide. Before and after each treatment regimen patients will undergo an assessment,     which will consist of anterior rhinomanometry and polysomnography with concomitant     measurement of snoring indices and breathing route pattern.      The investigators hypothesize that the application for one week of nasal budesonide has a     beneficial effect on snoring indices in patients who present before the application decreased     proportion of nasal breathing epochs and in whom nasal budesonide succeeded in increasing     nasal breathing epochs.   "
109875|NCT01847794|"     To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the     HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.      Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.   "
109758|NCT01849354|"     The women's clinic at Turku University Hospital has also since year 2000 accomplished and     systematically increased advanced surgical treatment for the endometriosis patients with     difficult disease. The aim is to centralize endometriosis treatment in the hospital district     and by doing that be able to offer exact diagnosis, advanced surgical treatment and     infertility treatment for every patient in the hospital area. The main purpose of this study     is to find out how the operative treatment of endometriosis patients in Turku University     Hospital is functioning and to see how the quality of life of these patients is before and     after the surgery. Furthermore, the structure of the endometriosis patients' endometrium and     the different markers of blood and urine are studied.   "
109759|NCT01849341|"     It is a phase IV clinical trial: longitudinal, prospective, evaluator-blind, randomized into     2 groups of patients with chronic obstructive pulmonary disease (COPD). The intervention     group was based on the administration of roflumilast 500 mcg per day on alternate days     (roflumilast 500μg eod) for 2 weeks (phasing). In the control group assigned to undertake the     treatment according to the standard dosage (roflumilast 500μg od).      The patient monitoring will be done by one of the sub-investigators fully independent team     that started the medication keeping the pattern masking by single blind, and since it aims to     assess the frequency of adverse events (AEs) in both groups were collected systematically     different AEs and their characteristics at 15 days (V1), and from that moment a month (V2)     and 2 months (V3). Likewise, other data collected (functional demographic, comorbidities,     home treatment, anxiety and depression and quality of life).      The purpose of this study is to assess whether the administration of roflumilast by a gradual     pattern varies the incidence of discontinuations due to adverse events when compared with the     usual dosage.   "
109760|NCT01849328|"     Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the     Spectrosense EVA system, which is combination of a gas chromatography (GC) and software     algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the     best discrimination between Breast Cancer sick population and healthy population. The gold     standard for identifying sick/healthy population is biopsy proven breast cancer.   "
109770|NCT01849198|"     Accelerometric Assessment of neuromuscular block during anaesthesia is routinely performed at     the M. adductor pollicis. However, many operations require positioning of the patients with     arms attached to the body. In these situations, the anaesthesiologist has no access to the     m.adductor pollicis.      In this study, a new position of accelerometry at the neck is evaluated: Stimulation of the     n. accessorius with accelerometry of the m. trapezius.   "
109771|NCT01849185|"     The primary objective is to examine whether probiotics given to hypercholesterolemic patients     treated with statins, would further decrease LDL-Cholesterol levels.      The secondary objective is to examine whether adding of probiotics to statins would decrease     fasting glucose levels and glycolysated hemoglobin   "
109772|NCT01849172|"     The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms     of menopausal transition .   "
109761|NCT01849315|"     Obesity is associated with increased risk of heart disease and diabetes (Kim et al., 2010).     Appalachian children in Athens County, Ohio, experience higher rates of obesity compared to     the national average (20.9% vs. 15.4%), which increases their risk of obesity-related     diseases (Montgomery-Reagan, Bianco, Heh, Rettos, & Huston, 2009). Although physical activity     (PA) is known to improve fitness and adiposity (Gutin & Owens, 2011; Yin et al., 2009), very     little is known about the effects of PA on the progression of chronic disease risk factors     (biomarkers) for obesity-related diseases in children, such as inflammatory markers, lipids,     and glucose/insulin. This lack of knowledge is due to a limited understanding of the number     of calories burned during children's free-play PA. This study will assess the impact of a PA     program (ACT) of known energy cost on obesity-related disease markers in 2nd-4th grade     children compared to a sedentary control group (SED). The study will recruit children from an     after-school program in Athens County elementary schools. Baseline and posttest data will     include measures of height, weight, body composition, blood pressure, and physical activity     levels. Following baseline measures, children will be randomized into either the ACT or SED     group for 8 weeks. The ACT group will play recess-type games previously determined to expend     ≥100 calories in 30 minutes. The SED group children will play sedentary-type activities     during the same time period. It is hypothesized that the ACT group children will demonstrate     significant improvements in PA after 8 weeks compared to the SED group children and that     these improvements will be related to positive changes in body weight and body composition.   "
109762|NCT01849302|"     Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance     becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion     adults being overweight.      Consumption of foods that can affect appetite by increasing satiety could regulate the total     energy intake and thus body weight. There is data suggesting that the macronutrient     composition of the foods and especially protein content may have a potent role on satiety.     However, it is difficult to pinpoint the optimum quantity needed to observe significant     effects of protein on satiety.      The research project is dedicated to identify which food components [proteins, carbohydrates     (CHO), fats] and the optimized protein quantity needed to accelerate satiation, suppress     appetite and extend satiety until hunger appears again.      It is hypothesized that the consumption of protein-enriched meals will induce a reduction in     hunger through the impact on gut hormones and peptides that are closely related to the     short-term regulation of food intake.   "
109763|NCT01849289|"     This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the     trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin     naïve subjects with type 2 diabetes.   "
109764|NCT01849276|"     The purpose of the study is to determine if metformin in combination with cytarabine is safe     and effective. Participants in this research study have acute myeloid leukemia (AML) that has     come back after initial treatment or has not gone away with initial therapy.There is evidence     that metformin directly kills leukemia cells. Laboratory data have also shown that     combinations of metformin with cytarabine are more efficient than each agent alone in killing     leukemia cells in the laboratory.   "
109765|NCT01849263|"     This phase II trial studies how well ibrutinib works in treating patients with follicular     lymphoma that has come back after a period of improvement or does not respond to treatment.     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth.   "
109766|NCT01849250|"     This randomized phase II trial studies how well docosahexaenoic acid works in preventing     recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence     in breast cancer survivors.   "
109876|NCT01847781|"     The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13)     in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the     antibody response will be impaired in patients as compared with controls. In contrast, we     postulate that the cellular immune response will be intact.   "
109894|NCT01847547|"     This cohort study plans to identify initiators of oral anticoagulants using electronic claims     data from a commercial insurance database to quantify associations between anticoagulant     choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with     non-valvular atrial fibrillation at risk for stroke.   "
109767|NCT01849237|"     Septic shock remains a significant clinical problem associated with high rates of mortality     among neutropenic patient despite antimicrobial therapy and supportive care. Recently,     mesenchymal stromal cells (MSC) have demonstrated remarkable potential effect in sepsis. MSC     treatment significantly reduced mortality in septic mice receiving appropriate antimicrobial     therapy. MSCs reduced systemic inflammatory cytokine levels in mice, down-regulated of     inflammation and inflammation-related genes (such as interleukin-10, interleukin-6).     Bacterial clearance was greater in MSC-treated mice. Thus, MSCs have beneficial effects on     experimental sepsis and suggest that MSСs-therapy may be an effective adjunctive treatment to     reduce sepsis-related mortality.      The safety of MSCs is proved by Graft-versus-host disease treatment MSCs in patients after     bone marrow transplantation.      This study hypothesis is that MSCs reduce organ dysfunction/injury, systemic inflammation and     mortality in patients with septic shock and severe neutropenia.      The main goal of the study is to evaluate the impact of MSCs therapy on organ     dysfunction/injury, systemic inflammation and 28-day mortality in patients with septic shock     and severe neutropenia. All patients will be randomized in two groups: control group     (standard treatment of septic shock) and MSCs-group (standard treatment of septic shock +     MSCs infusion of 1-2 millions/kg/ day).   "
109768|NCT01849224|"     The primary outcome is the change in lower extremity edema-related symptoms. Secondary     outcomes include the compliance rate of management guidelines for lower extremity edema, the     performance rate for pelvic and lower extremity exercise.   "
109769|NCT01849211|"     Difficult mask ventilation might lead to a life-threatening situation, if endotracheal     intubation is also impossible and neuromuscular blocking agents (NMBA) inhibit spontaneous     ventilation. However, controversies exist if NMBA improve or impede face mask ventilation.     Therefore, the effect of NMBAs on mask ventilation is assessed in patients with predictors     for difficult face mask ventilation.   "
110577|NCT01838629|"     1. acquire the environmental iodine status of Hangzhou        2. acquire the iodine status of population in Hangzhou        3. acquire the prevalence of thyroid diseases in Hangzhou        4. explore the association between iodized salt and thyroid disease   "
109773|NCT01849159|"     Actively developing stem cells (SCs) transplantation techniques cause natural interest to the     problem of regeneration in the lungs. Numerous experimental studies proved the benefits of     different types of SCs in experimental models of pulmonary emphysema (PE).      G. Zhen et al. have shown that the transplantation of mesenchymal stem cells (MSCs) to rats     with papain-induced emphysema leads to their migration into the lungs, differentiation into     type 2 alveolocytes, and inhibition of apoptosis and prevention PE.      K. Schweitzer et al. have proved the activity of inflammation in the airways, alveolocytes     and endothelial cells apoptosis decreased after adipose SCs intravenous administration to     mice with emphysema caused by chronic exposure to tobacco smoke or VEGF receptors blockade.     The study of E.P. Ingenito et al. found that endobronchial installed MSCs engraft into the     alveolar wall and peribronchial interstitium and release integrins, extracellular matrix     components (collagen IV, laminin and fibrillin), platelet-derived growth factor receptor and     transforming growth factor β2.      Our study also found reliable deterrent effect of allogeneic bone marrow MSCs on the     development of elastase-induced emphysema in rats at different terms of transplantation.      After the success of pilot studies have started clinical trials. Currently, the website     http://www. ClinicalTrials.gov reported three studies evaluating the efficacy and safety of     MSC transplantation in patients with COPD and emphysema. Two of them have already been     completed and the results of the first pilot project published.      Authors on the example of 4 patients showed a complete absence of adverse effects, improved     quality of life and stability of functional parameters at 12 months after starting treatment     One of the problems of MSC transplantation in patients with respiratory failure is an     accelerated apoptosis of transplanted cells under the influence of proinflammatory cytokines     and oxidative stress. Since it is proved that preconditioning MSCs under hypoxia increases     their survival in hypoxic conditions, increases the expression of growth factors and     antiinflammatory cytokines, we suppose that MSCs grown in hypoxic medium may have a     significant positive effect on the disease.   "
109774|NCT01849146|"     This phase I trial studies the side effects and best dose of WEE1 inhibitor AZD1775 when     given together with radiation therapy and temozolomide in treating patients with newly     diagnosed or glioblastoma that has come back. WEE1 inhibitor AZD1775 may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses     high energy x rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving WEE1     inhibitor AZD1775, radiation therapy, and temozolomide may work better in treating patients     with newly diagnosed or recurrent glioblastoma.   "
109775|NCT01849133|"     The purpose of this study is to investigate the efficacy of exclusive intraoperative     radiation therapy after conserving surgery in early-stage breast cancer compared with whole     breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any     recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence     occurring in quadrants other than the previous one) and the recurrence free survival.   "
109794|NCT01848886|"     Coronary artery bypass grafting (CABG) using the radial artery (RA) has since the nineties     gone through a revival. The initially reported worse outcome in RA graft patients compared to     patients grafted with the saphenous vein (SV) has since been corrected. Studies have shown     better patency when using RA, so the RA is going to be preferred more and more especially in     younger patients where long time patency is critical. During the last 10 years endoscopic     techniques to harvest the RA have evolved. Multiple different techniques have been used, but     now the equipment and technique have been refined and are highly reliable. The investigators     hypothesize that the endoscopic technique has less complications and a just as good patency     as open harvest. There are also two possible ways to use the RA as a graft. One way is sewing     it onto the aorta and another way is sewing it onto the mammarian artery. The investigators     hypothesize that using it on the mammarian artery is superior as a revascularisation     technique with just as good a patency as sewing it directly onto the aorta.   "
109795|NCT01848873|"     To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and     plasma homocystein.   "
109776|NCT01849120|"     Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for     congenital heart disease are at great risk for experiencing life-threatening low cardiac     output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and inadequate     oxygen delivery that occurs may result in multiple organ failure and death. It is LCOS that     is responsible for the majority of early postoperative deaths in this population of neonates     and infants. Improved pediatric probes placed in peripheral locations using near infrared     spectroscopy (NIRS) may permit continuous monitoring of venous saturations reflecting overall     perfusion and oxygen balance in the tissues. Following parental or guardian consent, 30     neonates and infants scheduled to undergo surgery for congenital heart disease will be     enrolled. At the end of surgery, four EQUANOX Advance 8004CB probes will be placed on the     flank, lower extremities and the forehead. Continuous NIRS saturations will be monitored and     stored for analysis. Point of care (POC) lactates will be obtained after admission to the     intensive care unit (ICU) every 2 hours for the first 24 hours postoperatively, then once at     48 hours. The association between NIRS oxygen saturation and POC lactate values will be     assessed using mixed linear models taking into account the repeated measures design.     Exploratory analyses will be performed to assess whether NIRS oxygen saturation is associated     with outcomes such as days in ICU, adverse events and mortality.      The ability to use noninvasive, continuous monitoring for overall perfusion and cardiac     output will allow better and earlier therapy for neonates and infants following cardiac     surgery.   "
109777|NCT01849107|"     Small bowel irradiation results in epithelial cell loss and consequently impairs function and     metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The     investigators evaluate the correlation between plasma citrulline level, dose-volume histogram     of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse     Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a     biomarker for quantifying radiation-induced epithelial cell loss.   "
109778|NCT01849094|"     To determine the pharmacokinetic profile of a new (extended release) formulation of milrinone     and to demonstrate evidence of hemodynamic effect      Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort)     - to demonstrate evidence of haemodynamic benefit      Study Design: Open label   "
109779|NCT01849081|"     We are doing this research study to evaluate whether continuous positive airway pressure     (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea is     a disease where a person has interruptions in their breathing while they are sleep. This can     lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high pressure     to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known treatment for     sleep apnea.   "
134401|NCT01525641|"     Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily     use of Mirapex®-LA Tablets in patients with Parkinson's disease.   "
109780|NCT01849068|"     Ezetimibe has been shown to inhibit cholesterol absorption and several lines of evidence from     in vitro systems and animal models suggest that this effect is associated with an increase in     low-density lipoprotein (LDL) receptor expression in the small intestine. The impact of a     treatment with ezetimibe on intestinal gene expression and protein mass levels of LDL     receptor and other key genes involved in intestinal cholesterol homeostasis will be examined     in dyslipidemic men with insulin-resistance. In the present study, gene expression studies     and protein mass levels will be assessed on duodenal biopsies by real-time polymerase chain     reaction (rt-PCR) and liquid chromatography-mass spectrometry (LC-MS/MS), respectively. The     primary objective of this proposal is to examine the effects of ezetimibe on intestinal gene     expression (rt-PCR) and protein mass levels (LC-MS/MS) of LDL receptor in dyslipidemic men     with insulin-resistance. The secondary objective is to examine the impact of ezetimibe     treatment on intestinal gene expression and protein mass levels of sterol regulatory     element-binding protein (SREBP)-2, Niemann-Pick C1-Like1 (NPC1L1), ATP binding cassette gene     (ABCG)-5/8, proprotein convertase subtilisin/kexin type 9 (PCSK9) and     3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase.      Primary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal     mRNA and protein mass levels of LDL receptor in dyslipidemic men with insulin-resistance.      Secondary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal     mRNA and protein mass levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase in     dyslipidemic men with insulin-resistance.   "
109781|NCT01849055|"     This is a study of LY3023703 in healthy participants. The purposes of this study are to look     at safety, how well the study drug is tolerated, how much of the study drug gets into the     blood stream and how long it takes the body to remove the study drug. The effects of     LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any     side effects that occur will be collected. The study is expected to last 21 weeks.   "
109782|NCT01849042|"     This study will evaluate the pharmacological efficacy on language capability and compliance     with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients     with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine     on language capability in moderate to severe Alzheimer's disease patients who are taking     stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on     cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in     probable AD.   "
109805|NCT01848743|"     In Taiwan, 15% of general population had hepatitis B virus (HBV) infection, HBV is the     leading cause of liver cirrhosis and hepatocellular carcinoma in Taiwan. After entering     immune clearance, 10-30% of patients of chronic HBV develop acute exacerbation (AE) , some     are mild but some developed hepatic decompensation or even death.      Previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl     can improve survival in chornic HBV with severe AE. From the study from Hongkong, lamivudine     was found to have better survival than entecavir in chronic HBV with severe AE. Recent study     from India found that tenofovir is able to improve survival in chronic HBV with severe AE.     The aim of this study is to compare the effect of lamivudine and tenofovir for chronic HBV     with severe AE.      The study aims to enroll 120 patients with chronic HBV defined as persistence of HBsAg for     more than 6 months. Severe AE was defined as ALT > 400 U/L, prolongation of prothrombin time     > 3 seconds, bilirubin > 2 mg/dl. Patients with hepatitis A, C, D or HIV infection, drug or     alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or     previous use of anti-HBV agents are excluded. All enrolled patients are randomized into group     A who received tenofovir 300 mg qd for 3 years and group B who received lamivuidne 100 mg qd     for 6 months, followed by tenofovir 300mg qd for 30 months. Mortality rate and virological,     biochemical and serological response were evaluated at 1,2,4,48,96 and 144 weeks. The values     are expressed as mean + SD. Categorical variables were analyzed with Chi-square test or     Fisher's exact test as appropriate and continuous variables were analyzed by Mann-Whitney     test. Logistic regression test was applied to analyze the independent association of various     variables with outcome. A p value < 0.05 was regarded as significant.   "
109783|NCT01849029|"     Many American Indian (AI) women never receive services for serious mental health problems     resulting from traumatic events, violence exposure and maltreatment. AI women suffer higher     lifetime rates of Post-traumatic Stress Disorder (PTSD) (20-23%), that often co-occur with     excessive drinking and risky sexual behaviors. These factors magnify risk for human     immunodeficiency virus and sexually transmitted disease (HIV/STI). In full development with     tribal partners, this application, proposes a 3-year project to culturally adapt and pilot an     empirically supported trauma-focused treatment, Cognitive Processing Therapy (CPT) for PTSD,     substance use and HIV/STI sexual risk behavior among 50 AI women. Additionally, the     investigators will assess the feasibility, acceptability and treatment fidelity of delivering     CPT via AI community health workers in a resource-limited tribal reservation. This project     brings a culturally responsive intervention to an understudied and highly vulnerable     population. Its significance lies in its potential to advance science in the area of PTSD,     substance use treatment and HIV/STI prevention among AI women. Study data would benefit     tribal and rural communities and the mental health field. Finally, it is geared toward     developing the research infrastructure and mental health treatment capacity serving AI women     living in rural settings, a group at risk for an expanding HIV/AIDS epidemic. If successful,     findings from this pilot will provide evidence for a larger effectiveness trial.      The AIMS are AIM I. Adapt the evidence-based CPT intervention in full collaboration with     tribal partners. This will be done in accordance with the CDC's Map of Adaptation Process and     involves formative research with tribal leaders, potential consumers, providers, and health     care administrators using qualitative methodology.      AIM 2. Assess this intervention delivered by Native American community health workers for     feasibility and acceptability in a resource-limited rural reservation setting.      AIM 3. Conduct a two-group, single-site waitlist randomized controlled pilot trial of a     12-session, 6-week CPT intervention among 56 (6 pilot) sexually active and substance using AI     women with PTSD or sub-threshold PTSD. Determine preliminary efficacy and estimate an effect     size in terms of three primary outcomes: (a) PTSD symptomatology; (b) substance use; (c) high     risk sexual behavior.   "
109784|NCT01849016|"     The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the     frequency of pain in daily life in patients with Sickle Cell Disease (SCD).      Pain is an invalidating hallmark of this disease and has a considerable impact on the Quality     of Life of patients and the medical health care system. Oxidative stress is hypothesized to     play a central role in its pathophysiology. In pilot studies the administration of     N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress. Moreover, administration     of NAC seemed to decrease hospitalization for painful crises in a small pilot study in     patients with SCD.      This study will be performed as a multicenter, randomized, controlled trial where patients     will be treated with either NAC or placebo for a period of 6 months. The investigators expect     that NAC can reduce the frequency of pain in patients with SCD, thereby improving their     quality of life and participation in society.   "
109798|NCT01848834|"     This study is being done to investigate the safety, tolerability and anti-tumor activity of     pembrolizumab (MK-3475) in participants with advanced triple negative breast cancer (TNBC)     (Cohort A), advanced head and neck cancer (Cohorts B and B2), advanced urothelial cancer     (Cohort C), or advanced gastric cancer (Cohort D). Additionally, for Cohort D, data is     presented for Asian Pacific (AP) participants. Only participants with programmed cell     death-ligand 1 (PD-L1) expressing tumors were enrolled in Cohorts A, B, C and D. Participants     in Cohort B2 were enrolled irrespective of PD-L1 status.      The primary study hypothesis is that pembrolizumab is safe and well-tolerated.   "
109785|NCT01849003|"     This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval     in participants with Long QT-3 syndrome. This study will be performed in six cohorts of     participants in a sequential manner, four single-dose cohorts followed by two multiple-dose     cohorts. Duration of treatment for the single-dose cohorts and multiple-dose cohorts will be     1 day and 7 days, respectively. Participants will be confined at the study center from     check-in until completion of assessments at discharge.      Participants will be continuously monitored using real-time telemetry throughout the     in-clinic confinement. Physical examinations including vital signs, laboratory analysis,     electrocardiograms (ECGs), Holter recordings and echocardiography (ECHO) will be performed at     defined time points throughout the study period. Assessment of adverse events and concomitant     medications will continue throughout the duration of the study.   "
109786|NCT01848990|"     The primary objectives of this study are to compare the difference in glycosylated hemoglobin     (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous     subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of     Hylenex recombinant preadministration, including local tolerability, adverse events, and     hypo- and hyperglycemia rates.   "
109787|NCT01848977|"     Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two     device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA).     Each probes are attached to both thenar muscles and vascular occlusion test (VOT) is     performed. The investigators will compare the Invos® data to InSpectra™ to investigate     whether tissue oxygen saturation values by INVOS® can substitute for InSpectra™.   "
109788|NCT01848964|"     This study aims at evaluating the relation between quality of the interface between the stump     and the prosthesis, and the quality of gait in above-knee amputees.      The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee     amputees corresponds to an homogeneous pressure distribution pattern onto the stump.   "
109789|NCT01848951|"     This study intends to examine this rational by comparing the infiltrative     transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal     surgery . The efficacy of the TAP block for abdominal surgery is well documented in the     literature (McDonnell 2007) (Kadam 2011), but there are no studies utilizing long-acting     bupivacaine. The investigators believe the primary outcome will demonstrate no difference     between the two in terms of pain scores and opioid consumption. The investigators anticipate     that patients who have undergone TAP blocks will have improved secondary outcomes with     respect to a decreased costs, urinary retention, and hypotension.   "
109790|NCT01848938|"     The purpose of this study is to determine whether treatment of stress urinary incontinence     (SUI) via smartphone is effective.   "
109791|NCT01848925|"     The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in     patients suffering from Sickle Cell Disease.   "
109792|NCT01848912|"     The purpose of this study is to find a way of detecting infection earlier in patients     receiving bone marrow transplant. This is accomplished by continuous individualized     monitoring of heart rate, respiratory rate and temperature variability in this patient     population. The investigators are collecting data to determine whether or not subtle     differences in heart rate, respiratory rate and temperature will help physicians to detect     infection earlier in order to begin faster treatment before a patient's condition     deteriorates. Blood tests will also be performed to check for certain biomarkers that may     indicate infection   "
109793|NCT01848899|"     The aim of this study is to determine how two different types of iodinated contrast media     (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific     markers of thrombogenesis and platelet function in patients undergoing coronary angiography,     and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary     intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet     function.   "
109806|NCT01848730|"     To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain     experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three     weeks of treatment compared to the baseline period.   "
109796|NCT01848860|"     Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung     disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the     lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated     in patients with recurrence or persisted air leakage. In recent years, thoracoscopic     bullectomy with pleural abrasion is getting popular, thanks for the advance of endoscopic     instruments and technique. The pneumothorax recurrence rate after thoracoscopic surgery is     around 10%, which is significantly higher than that of thoracotomy. In addition, the rate of     postoperative prolonged air leakage is 5-8%. The possible causes of recurrent pneumothorax     and prolonged air leakage are missed bleb surrounding the endoscopic suture line or     suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications, a     novel method using coverage of the endoscopic suture line by a large absorbable mesh during     thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can     strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce     the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, the     investigators are conducting a prospective randomized trial in National Taiwan University     Hospital. The investigators will enroll 204 patients with primary spontaneous pneumothorax     who will be randomly assigned to additional mesh pleurodesis (mesh group, 102 patients) or     not (control group, 102 patients) after thoracoscopic bullectomy and pleural abrasion. The     primary endpoint is to compare the rate of pneumothorax recurrence within one year between     the two groups. The secondary endpoints are to compare the safety, efficacy, and long-term     pulmonary function between the two groups.   "
109797|NCT01848847|"     The purpose of the study is to investigate the advantages and disadvantages of bladder     filling during hysteroscopy procedure.   "
109818|NCT01848561|"     This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in     patients with moderately to severely active UC who are treated as recommended in the product     label.   "
110986|NCT01833247|"     This project looks at the time course of lactic acid rise (if any) after seizures. Salivary     and capillary lactic acid are tested. This type of measurement may be useful in signalling     the occurrence or recent history of a seizure.   "
109799|NCT01848821|"     The aim of this study is to evaluate the speed and quality with which OASIS® Ultra     (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical     sized defect. The investigators intend on confirming the histological composition of the     dermal substitute in order to delineate the amount of cellular recruitment, collagen     deposition and neovascularization present compared with control wounds. The investigators     hypothesize that OASIS® Ultra will provide a faster healing time as well as the     re-establishment of a dermis for further skin graft application. The investigators anticipate     that our study will define parameters for the application of OASIS® Ultra as well as     potentially demonstrating the advantages in healing time, healed wound quality and hospital     stay.   "
109800|NCT01848808|"     The general objective of this project is to examine the impact of Wobenzym PS supplementation     on blood markers of inflammation and inflammation gene expression in volunteers with     sub-clinical inflammation.      The study will be undertaken according to a double-blind, cross over, randomized, placebo     controlled design. The study will involve men and women with subclinical inflammation (n=24).     Eligible subjects will have blood CRP >1 mg/L and <10 mg/L and will be in good health. The     impact of Wobenzym PS on inflammation (vs. placebo) will be assessed by comparing the blood     fasting concentrations and whole blood gene expression of anti- and pro-inflammatory proteins     before and after the 4-week supplementation (Wobenzym and placebo). The two 4-week     supplementation will be separated by a 4-week wash out period.   "
109801|NCT01848795|"     Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured     or improved following bariatric surgery. This could be explained by weight loss or by changes     of nutrient absorption or gut hormone secretion. The comparison of glucose metabolism in     patients undergoing malabsorptive or mechanical procedures will clarify this matter.     EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical     procedures while the endoscopically placed intragastric balloon induces weight loss with a     mechanical action.      The present study hypothesis is that the bypass of the first portion of the intestine     obtained with the EndoBarrier will be more effective in improving glucose metabolism than the     reduction of food intake obtained with the intragastric balloon. Since similar weight loss is     expected in the two groups, the study will aid in understanding the mechanisms behind the     metabolic improvement seeing after intestine bypass.   "
109802|NCT01848782|"     Objective: The investigators aim to evaluate the impact of a adding a  limitations  section     in systematic review's abstract on result's interpretation by readers Design: randomized     controlled trial with two parallel arms. Participants will be invited to participate in an     online survey.      Participants: Eligible participants are corresponding authors of clinical trials published     between 2010 and 2012 and referenced in Medline.      Intervention: The investigators will evaluate the impact of the presence of a  limitations      section in abstract of systematic review with meta- analysis. The investigators selected     abstracts of meta-analysis from a sample.      Selected abstract will be standardised and the treatment's name hidden. Two groups of     abstract will be presented as follow: 1) abstract without  limitations  section 2) abstract     with  limitations  section. The  limitations  section will be written by authors and will     briefly describe the risk of bias of included studies.      Selected participant are invited by e-mail to answer the survey. After reading one abstract     from his/her group of randomisation they are invited to answer 5 questions about their     interpretation of the results.   "
109803|NCT01848769|"     The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after     single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and     Formoterol pMDIs, in asthmatic children (5 to 11 years old).   "
109804|NCT01848756|"     Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an     experimental drug that blocks Hsp90   "
109807|NCT01848717|"     The objective of this clinical test is to verify the safety and efficacy of MINTLIFT®, used     for the purpose of improving the appearance of the nasolabial fold on both sides of the face.   "
109808|NCT01848704|"     1Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid     dissemination of trial results and their translation into clinical practice is particularly     important. Abstracts published or presented in conferences are a large, rapid and free method     to disseminate these results. However, this mode of dissemination may have serious     consequences for patients if abstracts are not an accurate and unbiased reflection of the     trial results. Indeed, investigators have great freedom when writing their abstracts and     articles. They can choose the data to present and decide how to present them. Consequently,     they have many opportunities to shape readers' impressions of their results, that is, to add     spin (ie, spin is a specific way of reporting to convince readers that the beneficial     effect (efficacy, safety) of the experimental treatment is higher than shown by the results).      Objective: To assess the impact of spin on the interpretation of results in abstracts of     randomized controlled trials with nonstatistically significant results in the field of     cancer.      Design: The investigators performed a RCT comparing the interpretation of results in     abstracts a) with and b) without spin.        1. Identification of abstracts of randomized trials with spin. The investigators selected a          sample of negative published RCTs (i.e. non statistically significant results) with a          spin in abstract conclusion identified in previous works. Inclusion criteria were 1)          RCTs with non statistically significant primary outcome, 2) spin in the abstract          conclusion.        2. Abstracts' modification Selected abstracts were systematically rewritten to contain no          spin. All abstracts were presented in the same format without the names of authors,          references, or the name of the journal in which it was published, and the names of          treatments were masked by using generic terms (e.g., treatment A, comparator B). All          abstracts had the same number of words +/-20        3. Assessment Abstracts were assessed by corresponding authors of randomized trials,          experts of specific grants and investigator of trials registered in clinicaltrials.gov.          Experts were invited to participate in our study. They were not informed of the          objectives of our study. Each clinician were randomized to evaluate 1 abstracts with or          1 abstracts without spin.        4. The primary endpoint was the interpretation of abstract results by the participants. All          readers participating in the study evaluated the abstract of randomized trial and          answered the following question: Based on this abstract, do you think treatment A would          be beneficial to patients? (answer: numerical scale from 0-10)   "
109809|NCT01848691|"     People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans.     These red blood cells breakdown faster, and this is called hemolysis. When red blood cells     breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is eliminated     in exhaled breath. This research study will use a device called CoSense™, which will measure     Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how well the device     measures the CO levels that an individual breathes out.   "
109859|NCT01848015|"     To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced     gastric cancer after radical resection.      To identify the relationship between the detection of circulation tumor cells and recurrence     patterns of gastric cancer after radical resection.   "
109860|NCT01848002|"     This trial was conducted in Europe. The aim of this trial was to investigate safety and     pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in     healthy volunteers.   "
109810|NCT01848665|"     Increased core temperature (hyperthermia) has been associated with impaired neuromuscular     performance; however, the mechanisms associated with these performance decrements and their     potential synergies remain unclear. While the majority of research suggests that the observed     fatigue is related to the central nervous system, the influence of changes in cerebral blood     flow (CBF) and associated changes in cerebral alkalosis (estimated by end-tidal partial     pressure of carbon dioxide; PETCO2) remains unexamined. In response to hyperthermia, humans     hyperventilate as means of heat dissipation, resulting in a hypocapnia (reduced PETCO2)     mediated decrease in CBF and consequently, cerebral alkalosis (increased cerebral pH).     Previous research suggests that hyperventilation induces changes in neural excitability and     synaptic transmission; however, it remains unclear if these changes are related to hypocapnia     mediated decrease in CBF or decreased PETCO2 or both.      The purpose of the proposed research program is to examine the influence of changes in CBF     and cerebral alkalosis on neuromuscular function during passive heat stress. The research     project will consist of 3 separate experimental trials: (a) poikilocapnic hyperthermia     (increased core temperature; decrease CBF; decrease PETCO2), (b) isocapnic hyperthermia     (increased core temperature; no change CBF; no change PETCO2) and (c) isocapnic hyperthermia     + indomethacin (increased core temperature; decrease CBF; no change PETCO2). During each     manipulation, neuromuscular function will be evaluated and compared to baseline     (normothermic) conditions using a repeated measures design.      It is hypothesized that changes in PETCO2 and therefore, changes in cerebral alkalosis will     contribute to neuromuscular fatigue independent of changes in CBF or increases in core     temperature.   "
109811|NCT01848652|"     The protocol is to assess the overall response rate (complete response and partial response)     of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination     with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell     refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding     strict eye lymphomas.      This is a Phase II, open, prospective, multicenter, non-comparative with direct individual     benefit.   "
109812|NCT01848639|"     This study is designed to etablish the effects of spironolactone in comparison to placebo on     the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome,     hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The     primary endpoint will be the time to onset of the first incident.   "
109813|NCT01848626|"     The objectives of this study are:        1. To collect data necessary for assessing the performance of advanced Vaginal Tactile          Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;        2. To assess the clinical suitability of the interface software to facilitate the data          collection process and to get in vivo examination data for validation of visualization          and analysis routines;        3. To test the data collection technique and establish a reliable examination procedure.   "
109814|NCT01848613|"     Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine     in the treatment of advanced NSCLC. A phase IV study.      ShortTitle/ Acronym: VIVOS      Protocol Code :IRST162.05      Study Design: Randomized, open label cross-over study      Study Duration: Two years      Study Center(s): Multicenter study      Objectives:      Primary: Patient preference for oral or intravenous vinorelbine Secondary: Overall Response     Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice.      Number of Subjects: 120      Diagnosis and Main Inclusion Criteria:      Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line     chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG)     Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2      Study Product, Dose, Route, Regimen and duration of administration :        -  Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine          (60mg/m2)        -  Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV          vinorelbine (30mg/m2) In both arms vinorelbine will be given at day 1 and day 8 every 3          weeks. From the third cycle onwards patients will have to choose to receive oral or          intravenous vinorelbine. Vinorelbine capsules will be administered at the dosage of 60          mg/m2 for the first course and then may be increased to 80 mg/m² at physician's choice.      Treatment will be repeated every 21 days and continued until disease progression, intolerable     toxicity or patient refusal.      Reference therapy: Vinorelbine 30 mg/m2 intravenous day 1 and 8 every 21 days      Statistical Methodology: The sample size is calculated based on 75% of patients preferring     oral vinorelbine and 25% preferring intravenous vinorelbine. Therefore, the investigators     would compare patients preferring oral vinorelbine as 75% compared to a null hypothesis of     50% (no difference in proportion of patients preferring oral to intravenous). With 80%     power and a total alpha of 0.05, the estimated sample size is 60 for group (120 total).     During recruitment period, a formal interim analysis was planned when 60 patients (30 for     group) have been enrolled, with a p-value <0.0001. To claim statistical significance in the     final analysis, the overall p-value is still 5% (referred to Peto-Haybittle rule).   "
109877|NCT01847768|"     In this study, the following subjects will be exposed to human rhinovirus (HRV):        -  those with classification of mild-moderate asthma        -  healthy control subjects.      The investigators will study the kinetics of HRV-induced inflammatory and remodeling     responses in a well characterized group of asthmatic subjects and compare these outcomes to     those in a healthy, non-asthmatic control group.   "
109815|NCT01848600|"     Objective: The investigators aim to evaluate the impact of a  limitations  section in     systematic review's abstract on results' interpretation by readers.      Design: Randomized ratio 1:1 controlled trial with two parallel arms. Participants will be     invited to participate in an online survey.      Participants: Eligible participants are corresponding authors of randomized controlled trial     published between 2010 and 2012 and referenced in pubmed Intervention: The investigators will     evaluate the impact of the presence of a  limitations  section in abstract of systematic     review with meta-analysis. The investigators selected abstracts of meta-analysis published in     the journal Annals of Internal Medicine between 2006 and 2011.      Selected abstract will be standardised and the treatment's name hidden. The two groups of     abstract will be presented as follow: 1) abstract with  limitations  section and 2)     abstract without  limitations  section: the  limitations  section of the original     abstract will be deleted.      Selected participants are invited by e-mail to answer the survey. After reading one abstract     from his group a randomization they are invited two answer 5 questions about their     interpretation of the meta-analysis's results.   "
109816|NCT01848587|"     Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10%     of women. Our hypothesis is that offering acupuncture in addition to standard care would     reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units     will be randomized over a 3 year period to receive standard care or standard care plus     acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤     4/10. Secondary outcomes will compare groups for an impairment score and for direct and     indirect costs.   "
109817|NCT01848574|"     Evaluation of global understanding and with items of patients admitted to the emergency.      Prospective observational study randomized in cluster during 6 weeks in 14 centers   "
109819|NCT01848548|"     Awake tracheal intubation is the standard management for patients as risk for airway     compromise. It is also commonly done in cases where there is significant cervical spine     pathology i.e. cervical myelopathy or instability. The anesthetic technique used for the     awake intubation is crucial to the patient's safety. One of the most important aspects of the     anesthetic technique is airway anesthesia prior to placement of an endotracheal tube. The     superior laryngeal nerve is responsible for mediating the cough reflex around the vocal     cords. The investigators have developed an approach to reliably block the superior laryngeal     nerve by injecting local anesthetic near the nerve in a unique approach. Injecting local     anesthetic into or through the thyrohyoid membrane will effectively block the superior     laryngeal nerve   "
109820|NCT01848535|"     Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea     because of their ability to stimulate beneficial bacteria. In-vitro results showed a     promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids     (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota.     As the microbiota is nowadays considered as a key factor in human health, a further     understanding of the gut microbiota functioning in-vivo is essential. This understanding of     the use of specific prebiotics may possibly be beneficial in the prevention or recovery of     antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota     composition and activity from healthy adults receiving amoxicillin have never been tested     in-vivo, the investigators propose the current study as a proof of principle.      Objective:      To explore whether the promising effects of GOS supplementation on the composition and     activity of gut microbiota from healthy adults as found by in-vitro, can also be observed     in-vivo.      Study population:      10 healthy men and women volunteers, 18 - 40 yr old   "
109821|NCT01848522|"     The purpose of this study is to suggest system for improving patients' management through a     detail analysis of physical therapy departments functioning   "
109822|NCT01848509|"     Objective: Set up an interoperable telemedicine system for the follow-up of patients with     sleep apnea syndrome.   "
109823|NCT01848496|"     Regardless of the selected technique for dental impression, gingival displacement is an     essential procedure specially when making impressions of subgingival finishing lines, because     a moisture-free sulcus is a requirement for an effective impression.      The objective of this randomized clinical study is to evaluate the efficacy of the     conventional and cordless gingival displacement (GD) techniques.   "
109824|NCT01848483|"     The overall goal of this project is to implement and test the efficacy of an enhanced     comprehensive multidisciplinary early palliative care (EPC) package that includes four     motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the     innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance     care planning in a cost effective manner and could promote engagement and retention in HIV     care. If successful, it could serve as a model of early palliative care for persons with AIDS     in the US.   "
109825|NCT01848470|"     The purpose of this study is to investigate the safety and tolerability of 3 multiple and     escalating dose regimens of CG400549 administered orally in healthy volunteers.   "
109834|NCT01848340|"     This will be a two-part study in healthy adults. Part A is a phase 1, non-randomized, open     label, single-dose, single-centre mass balance study utilizing a radiolabeled dose to     investigate the recovery, excretion, and pharmacokinetics of oral GSK1265744 in a cohort of 6     healthy adult male subjects. Subjects will undergo a pre-study screening visit within 30 days     of the first dose and those who successfully pass pre-study assessments and meet eligibility     criteria will be enrolled into the study to receive the equivalent of a 30 mg dose of     GSK1265744 as an oral solution, containing approximately 70 microcuries (mcg Ci) [0.96     millisieverts (mSv)] of radioactivity under fasted conditions. Blood, urine and fecal samples     will be collected for a maximum of 504 hours (21 days) following study drug administration.     In Part B, approximately 10 healthy male and female subjects will be enrolled to evaluate the     single-dose safety, tolerability and PK of supratherapeutic dose of GSK1265744 150 mg     compared with placebo. Each subject will receive a single dose of GSK1265744 150 mg or     placebo on Day 1 under fasting conditions in the morning. Blood, urine and fecal samples will     be collected for 336 hours (14 days) following dosing.   "
109826|NCT01848457|"     Osteosarcoma is the most common type of bone cancer in children, adolescents and young     adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can     cure nearly two-thirds patients with osteosarcoma, but the treatment can also cause     irreversible damage to the kidneys and cause permanent hearing loss. The purpose of this     study is to evaluate new approaches to prevent these side effects without interfering with     the beneficial effects of the chemotherapy drugs on the cancer by using our knowledge of how     the drugs damage the kidney and cochlear hair cells in the ear to selectively block these     side effects. Preventing these side effects without interfering with the anti-cancer effect     of the drugs will improve the outcome in survivors and may also improve the effectiveness of     the chemotherapy regimen by preventing treatment delays and dose reductions that are often     caused by the side effects. Patients will be carefully monitored to ensure that the new     interventions do not adversely affect response to the treatment and do not increase the other     side effects of the chemotherapy. Specifically, we will monitor the nutritional status of the     patients closely and ask patients to complete a survey describing the side effects after each     treatment cycle. We will also collect a small sample of cancer tissue at the time of biopsy     and surgery from each patient on this study for testing to determine new classes of     anti-cancer drugs currently under development may have a role in treating osteosarcoma. If     effective, these new approaches to prevent kidney damage and hearing loss will be applicable     in other types of cancers treated with the same chemotherapy drugs.   "
109827|NCT01848444|"     Recent international data have shown that the levels of chemical substances found in human     milk could be at risk for breastfed infants. New data are necessary to assess this risk among     French newborns.   "
109828|NCT01848431|"     The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible     reduction of the transfusion threshold.        -  Trial with surgical intervention   "
109829|NCT01848418|"     The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis   "
136474|NCT01498419|"     The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus     PA-824 plus pyrazinamide regimen after 8 weeks of treatment.   "
109830|NCT01848392|"     Physical activity seems to be a prognostic factor for quality of life and survival in     patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed through     medical examination, their daily physical activity has been little studied. Activity monitors     have measured physical activity only in a few studies which considered mainly respiratory     status and more recently bone mineral density and body composition. Determinants of physical     activity in patients with CF remain largely unknown.      The objective of this study is to measure daily physical activity with activity monitors in     adult patients with CF and to investigate the determinants of physical activity, with a focus     on extra-respiratory factors (nutritional status, diabetes, bone mineralization, anxiety     and/or depression, cardiac impairment).      Seventy adult patients with CF, regularly cared at the Cochin adult CF centre, will be     recruited in a stable period during their annual review. During this assessment, laboratory     tests will be carried out (especially parameters for nutritional status), as well as     measurement of body composition and bone mineral density, respiratory function tests and a 6     minute walk test, and echocardiography. Patients will wear for 7 consecutive days a     multi-sensor armband SenseWear on the arm, to assess the intensity of physical activity in     metabolic equivalents (METS) and steps per day. Finally, patients will complete three     self-administered questionnaires: Quality of Life (CFQ14 +), hospital anxiety depression     scale and physical activity.      After a descriptive analysis of the study cohort, we will study qualitative and quantitative     criteria related to physical activity (assessed quantitatively by the number of steps/day or     metabolic equivalents).      Linear regression models will then be developed to assess the independent factors associated     with physical activity, adjusting for different variables of interest related to patients     demographic, behavioral, clinical (respiratory and non-respiratory ) and biological     parameters. Conversely, the predictive independent aspect of physical activity will be     studied according to respiratory function, nutritional status and quality of life.   "
109831|NCT01848379|"     White blood cell membrane and surface structures are affected by the metabolic disorders and     complications found in diabetes mellitus. Therefore, cellular activation, signal propagation,     intracellular signaling as well as bactericidal effector functions are altered.      When diabetic symptoms are corrected by the systemic intervention and treatment of the     patients (Anti-diabetic Therapy/ADT, i.e. anti-diabetic medication, diet and dietetic     supervision, physiotherapy and physical exercises), white blood cell functions will then     normalize and reach the functionality comparable to those cells derived from healthy     subjects.      Gum diseases like periodontitis have long been associated with and termed complications of     uncontrolled diabetes mellitus. Vice versa, after diabetic conditions are corrected,     periodontitis treatment will be proven effective, when oral hygiene regimen, full mouth     decontamination (FD, i.e. the oral use of topical antiseptics prior and after professional     mechanical tooth cleaning, tooth as well as root surface planing, polishing as well as gum     and soft tissue decontamination in combination with systemic antibiotics) are performed. To     reinforce gum healing, reinfection prevention (RP) as well as supportive periodontal therapy     (SPT) will be administered by dental professionals on an individual basis and a detailed     schedule.      If periodontal pockets critical for participant's self care are not eliminated by FD     including RP and SPT, and niches >5mm after 6 month persist, patients are informed and     offered surgical intervention as indicated for gum disease elimination.      Dental follow up exams will be offered to all participants.   "
109832|NCT01848366|"     Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device     and a microneedle patch electrode in patients with overactive bladder symptoms. The     investigators hypothesize that after at least 6 weekly treatments there will be modest     improvements in overactive bladder symptoms trending toward more improvement.   "
109833|NCT01848353|"     Among youth populations, American Indians have the highest prevalence of diabetes in the     United States. This study will use exercise as the principal lifestyle modification approach     to reduce the risk of diabetes in this population. The Choctaw Nation of Oklahoma has several     excellent, but underutilized wellness facilities in their Health Services Area in rural     Southeast Oklahoma, a low socioeconomic region. It has been established that exercise lowers     diabetes risk, and many overweight/obese, insulin resistant American Indian youth who live in     this region would benefit from an increase in regular exercise. The challenge is to modify     behavior so that routine exercise is established and maintained. The proposed study will test     whether monetary incentives can elicit greater frequency and duration of exercise in American     Indian youth when transportation and access barriers are reduced.   "
109847|NCT01848171|"     Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is     also reported increased risk for incidence of atherosclerosis and resulting coronary heart     disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine     replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid     patients, especially in those with mild or moderate subclinical hypothyroidism. The present     study was designed to investigate whether L-thyroxine replacement was effective in improving     serum lipid profiles and retarding atherosclerosis progress.   "
109835|NCT01848327|"     Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple     Sclerosis (MS). Treatment options are limited, and there is a pressing need for new     interventions to treat MS-related cognitive impairment. Glucose (a type of sugar) is used to     fuel the cells of the healthy brain. For people with neurological conditions such as MS,     glucose is not converted into energy as efficiently as it would be in a healthy brain, which     can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this     problem by providing an alternative energy source that is metabolized in the liver and used     by the brain.      Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on     cognitive impairment in multiple sclerosis.      Design: Randomized, double blinded, placebo controlled trial of 158 subjects.      Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd     Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90   "
109836|NCT01848314|"     Many studies have studied the effect and safety of renal denervation. However, it remains     unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a     difference in renal blood flow occurs after treatment. In the light of this ignorance,     current study will investigate whether renal denervation leads to a difference in renal blood     flow after treatment with renal denervation.   "
109861|NCT01847989|"     This trial was conducted in Europe. The aim of this trial was to investigate safety and     pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII)     in healthy volunteers.   "
109862|NCT01847976|"     The purpose of this study is to see if women with bone metastases from breast cancer will     benefit from the addition of doxycycline to their standard bone-targeted therapy.     Participants will be asked to take 100 mg of Doxycycline orally twice a day for 12 weeks.     Blood and tissue collection will further define the mechanism of the benefits if there are     any.   "
111013|NCT01832896|"     The objective of this study is to evaluate the safety and tolerability of a single     Subcutaneous (SC) dose of Ecallantide in children and adolescents with Hereditary Angioedema     (HAE).   "
109837|NCT01848301|"     Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second     leading cause of late mortality after heart transplantation. CAV has been associated with a     variety of traditional risk factors for atherosclerosis; however, immune mediated injury from     development of de-novo donor-specific antibodies after transplantation also likely plays an     important role. Similar to the progression of traditional atherosclerosis, it is likely that     endothelial dysfunction is the precursor to the development of intimal thickening and CAV.      The investigators hypothesize that coronary allograft vasculopathy after heart     transplantation as defined by progressive neointimal hyperplasia is preceded by endothelial     dysfunction, which in turn is at least partly mediated by donor specific antibodies.      The investigators are proposing a prospective study in humans to test the above hypothesis     and further mechanistically understand how CAV progresses. In this study the investigators     will test for coronary endothelial function by infusing acetylcholine into the coronary     artery and measure intimal hyperplasia by optical coherence tomography (OCT) and compare     findings in patients with and without donor specific antibodies.   "
109838|NCT01848288|"     The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics     after phacoemulsification with the CENTURION® vision system configuration compared with the     INFINITI® vision system configuration.   "
109839|NCT01848275|"     Catheter-based renal sympathetic modification has been documented to be effective option for     blood pressure control in patients with resistant hypertension, but the safety is still     concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at     proximity may be enough for successful renal sympathetic modifications. This study was     designed to compare the efficacy and safety of full length versus proximal ablation of     bilateral renal arteries.   "
109840|NCT01848262|"     Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP     And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant     Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective     randomized clinical trial.   "
109841|NCT01848249|"     Compared to chronic dialysis, kidney transplantation provides recipients with longer survival     and better quality of life at a lower cost. In order to meet increasing demands for kidney     allografts, kidneys from older and sicker donors are being procured. This has led to greater     discard rates of donated kidneys as well as more complications for recipients, including     shorter allograft survival. Available clinical models to predict kidney allograft quality     have poor prognostic ability and do not asses the degree of kidney allograft injury. However,     allograft injury near the time of procurement can lead to major consequences for the     transplant recipient: greater risks of delayed graft function, poor allograft function and     premature loss of the transplant. Our proposal is based on the hypotheses that novel     biomarkers measured in donor urine and transport media at the time of procurement can assess     acute and chronic kidney injury and that distinct biomarker patterns will predict allograft     survival. In collaboration with five organ procurement organizations, we will collect urine     samples from consecutive deceased donors and samples of transport solution for every pumped     kidney. We will measure markers of injury, repair, inflammation and fibrosis. We will     determine mortality and allograft survival in all patients by linkage to the United Network     for Organ Sharing (UNOS) database (Overall Cohort). Additionally, we will perform a detailed     chart review of a subset of recipients (detailed cohort) and will also examine associations     between biomarkers and longitudinal graft function over five years after transplant. Early,     non-invasive and rapid assessment of donor kidney injury could drive better allocation     decisions and potentially reduce the rates of post-transplant complications. Further, these     new tools could provide a platform for clinical trials of therapies for allografts and kidney     transplant recipients aimed at ameliorating allograft injury.   "
109842|NCT01848236|"     We would like to determine if vitamin D insufficiency exists in different ethnic groups, if     it has an effect on bone mass and muscle function, if it has an impact on the function of the     cells of the immune system, and if the functioning level of these systems can be improved by     stabilizing the vitamin D levels to within normal limits.   "
109843|NCT01848223|"     The purpose of this study is to evaluate the quality of life of late postmenopausal Finnish     women and the factors affecting it.   "
109844|NCT01848210|"     The purpose of this study is to evaluate the efficacy and safety of the fixed-dose     combination of coumarin and troxerutin versus placebo in the symptomatic treatment of chronic     venous insufficiency.   "
109845|NCT01848197|"     RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse     and death in women with operable breast cancer.In the North American Inter-Group factorial     trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested     in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant     chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival     in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals     (supported by the use of granulocyte-colony stimulating factor) were better than the     conventional inconvenient weekly intervals.   "
109846|NCT01848184|"     The objective of this study is to assess the recurrence rate following the use of PARIETEX™     Composite Ventral Patch in primary ventral hernia repair by open approach with     intra‐peritoneal positioning.   "
109848|NCT01848158|"     The purpose of this study is to determine whether acupuncture is effective at improving     comfort in children on a ventilator in the intensive care unit. Our hypothesis is that the     patients receiving acupuncture will require less medications to keep them comfortable than     those who receive sham or fake acupuncture.   "
109850|NCT01848132|"     Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting     for between 30% and 50% of the patients. Although it is considered a curable disease, still     at least 40 % of the patients will fail first line chemotherapy. The International Prognostic     Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to     identify patients with different outcome.      There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The     survival of these patients remains poor, with EFS around 40%.      The combination of RCHOP with new drugs is an attractive approach to treat these patients.      The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2     years, with a diagnosis of DLBCL with an aIPI > 1 or an aIPI =1 with increased levels of     beta-2-microglobulin (above the Upper Limits of Normal.)   "
109863|NCT01847963|"     This study is a non randomized non comparative study with two Siddha formulations     Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts     existing for longer period. But there is no scientific data is documented about these     formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis.     After the preliminary drug standardization the clinical study is Started at The National     Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones     or Changes in the number and size of the stones with 45 days drug treatment.   "
109851|NCT01848119|"     Gabapentin has been very effective at treating pain after knee and hip operations,     hysterectomies, and many other types of operations. A previous study at the investigators'     hospital found that a single pre-operative dose of 600mg gabapentin produced a significant     reduction in pain after cesarean section. However, 19% of patients complained of sedation. A     subsequent study at the same institution looked to see if lowering the dose to 300mg would     decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The     results were inconclusive but it provided valuable information to guide the design of this     study.      The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a     48 hour low-dose course will produce improvement in pain scores. This study will compare the     efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and     200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women     undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin     will result in decreased pain scores and increased satisfaction.   "
109852|NCT01848106|"     This study is designed to determine the efficacy of REG1 compared to bivalirudin in     preventing periprocedural ischemic complications and major bleeding in patients undergoing     PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both     ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin has     shown similar rates of ischemic events while demonstrating a significant reduction in     bleeding and an improved net clinical benefit.      Evidence from previous studies indicates that pegnivacogin represents an extremely potent,     chemically unique anticoagulant that can be reversed by anivamersen across multiple     populations (refer to Section 1.2.2). The question that still remains is whether Factor IX     (FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously     studied agent while active control with anivamersen can preserve the benefit of reduced     bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive     study with an open-label, multi-center, active-controlled, randomized design to answer that     question.   "
109853|NCT01848093|"     chronic obstructive pulmonary disease (COPD) is typically associated with mucus     hypersecretion in the airways. In health, mucin is the major macromolecular component and is     responsible for the protective and clearance properties of the mucus gel. In a recent study     the investigators found that mucins are decreased and unstable in the sputum of adult cystic     fibrosis (CF) patients.      In this study the investigators want to investigate the differences on the mucin quantity and     quality of airway secretions during pulmonary exacerbation of patients with COPD.   "
109854|NCT01848080|"     In Canada, only 10 to 15% of individuals following a cerebral vascular accident (CVA) receive     intensive rehabilitation services. The majority of individuals return home with or without     rehabilitation services, as outpatient services are unable to meet the demand.     Telerehabilitation is a promising alternative approach that can help improve access to     rehabilitation services once patients are discharged home. The main hypothesis is: The     participants who received the intervention via telerehabilitation will have a gain in their     Community Balance and Mobility Scale (CB&M) score that will not be inferior to the gain     observed in participants who received the intervention via home visits (less than 4 points).     The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation     approach compared to home visits. The secondary hypotheses are: Two to four months following     discharge from hospital, the investigators hypothesize that the level of: 1) gain in physical     and psychological capacities related to mobility; 2) gain in the quality of life, and 3)     satisfaction of services received will not be inferior in the TELE group compared to the     VISIT group and that 4) the Tele approach will be more cost-effective compared to the VISIT     approach. The platform used will be based on a technological infrastructure that was     developed and tested in previous telerehabilitation studies. The study is a randomized     control trial (RCT).The study population of interest will target individuals who have had a     stroke who stayed in a hospital. Participants will be recruited during the hospitalization     period at each of the three sites. The investigators expect to recruit 240 participants, 120     per group. All evaluations will be completed in the research centers/hospitals of the three     sites and will last approximately 1.5 hours. The first evaluation will be conducted prior to     hospital discharge (T1) to establish the baseline measures. The two other evaluations will be     conducted 2 months (T2) and four months (T3) following discharge from hospital. The     independent variable is individualized exercise program, based on Tai Chi. The dependant     variables are Balance, functional mobility, physical capacities, psychological capacities     related to mobility and balance, quality of life, satisfaction with care received, cost of     services according to the healthcare system. The difference between the two groups will then     be compared using a t-test. The economic analysis will be a type of cost-effectiveness.   "
109855|NCT01848067|"     This phase I/II trial studies the side effects and best dose of alisertib when given together     with abiraterone acetate and prednisone and to see how well it works in treating patients     with hormone-resistant prostate cancer. Alisertib and abiraterone acetate may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause     the growth of prostate cancer cells. Drugs, such as abiraterone acetate, may also lessen the     amount of androgens made by the body. Drugs used in chemotherapy, such as prednisone, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving alisertib, abiraterone acetate, and prednisone together may be an     effective treatment for prostate cancer.   "
109856|NCT01848054|"     The purpose of the study was to assess the efficacy of induction treatment with     buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with     buprenorphine only. The hypothesis is that starting directly on OX219 works equally well     (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on     Day 3.   "
109857|NCT01848041|"     This is an exploratory, proof of concept study to evaluate the safety and efficacy of     RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in     patients with ptosis.   "
109878|NCT01847755|"     This study is designed to test the hypothesis that patients with Traumatic Brain Injury     (TBI)treated with Hyperbaric (HBO) will show improvement in function and an increased blood     flow as evidenced by single-photon emission computerized tomography (SPECT) scan. Improvement     is evidenced by increase in number of pixels on SPECT Scan and increased brain metabolism.     Improvement may also be identified via cognitive assessments administered by Jupiter Medical     Center Research Department.   "
109858|NCT01848028|"     Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely     confined to systemic therapy in Germany. Systemic therapy includes conventional systemic     therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g.     adalimumab, etanercept). While short- and middle-term efficacy of most systemic treatments     has been shown in clinical studies (and is incorporated in international guidelines),     knowledge about long-term outcomes, optimal treatment and effectiveness under real-world     conditions is still missing. PsoBest, the German registry on the treatment of moderate to     severe Pso and PsA started in 2008 and documents the long-term course of patients being     administered any biologic or conventional systemic antipsoriatic drug authorized in Germany     for the first time. The registry evaluates the long-term course of 3,500 patients with Pso     and PsA treated with systemic antipsoriatics.   "
136475|NCT01498406|"     Lupus is a disease in which the immune system, which normally fights infection, begins to     attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune     system attacks is called the autoantigen. Lupus can affect many parts of the body and often     affects the skin, with immune cells attacking autoantigens in the skin and causing a rash.     This rash is often visible to the public because it tends to occur on sun-exposed areas, for     example a patient's face, chest, and arms. For this reason, among others, skin lupus can be a     source of disability and poor health related quality of life in many patients with this     disease. It is not completely understood why or how someone might develop lupus, however     there are likely many reasons which include their genetics and also the kind of environment     they live in.      One such environmental factor, vitamin D, is more commonly known as a vitamin important for     bone health. However, we are learning that vitamin D has effects all over the body, and is     also important for a healthy immune system. Low levels of vitamin D have been associated with     an increased risk of other autoimmune disorders such as diabetes and multiple sclerosis, and     have also been found to be common in skin lupus patients.      Vitamin D is made in the skin when it is exposed to the sun, specifically ultraviolet B     radiation (UVB). The main source of vitamin D for most people is its production in the skin     because the normal American diet is not high in vitamin D. However, patients with skin lupus     tend to stay out of the sun because their rash is made worse by sunlight, which is thought to     produce more of the autoantigens in the skin attacked by the immune system. Additionally, as     skin doctors (dermatologists) we recommend sun protection to skin lupus patients to minimize     sun-sensitivity and prevent flares of their skin disease. However we may be putting them at     risk for low vitamin D status and even more severe disease. Another risk factor that puts     skin lupus patients at risk for vitamin D deficiency is that these patients generally have     darker skin types which blocks UVB and further limits vitamin D production in the skin.      Given that skin lupus patients are at high risk for low vitamin D status as mentioned above,     the investigators propose a research study that will provide information about vitamin D     levels in these patients. The investigators seek to identify how many skin lupus patients     have low vitamin D status and how vitamin D influences the natural history of this skin     disease. Additionally the investigators will evaluate whether or not supplementation with     high dose vitamin D will lessen the severity and negative quality of life impact of skin     lupus. Supplementation of vitamin D by mouth is an inexpensive, well tolerated, and safe over     the counter method to replete and maintain a normal vitamin D status. Studies in other     autoimmune diseases, specifically Crohn's disease and multiple sclerosis, have shown that     high dose vitamin D supplementation improves disease severity. It is the hope of the     investigators that this will also be observed in skin lupus patients.      In summary, the investigators seek to move beyond establishing an association between vitamin     D status and skin lupus. The investigators aim to elucidate the therapeutic benefit, if any,     of vitamin D status on disease severity and quality of life while controlling for important     factors that may influence vitamin D status. If the investigators are to show improvement in     disease severity with vitamin D supplementation, this would be a cost-effective additional     therapy to our standard clinical practice. Future research would also allow us to investigate     other alternative markers of vitamin D deficiency and disease activity in skin lupus     patients, a population at high risk for low vitamin D status and in need of further research.   "
109866|NCT01847924|"     Patients who have suffered from stroke may develop problems with thinking. Moreover, such     patients have a high risk of becoming demented, more dependent or dying. Therefore, further     studies are urgently needed to find effective and safe treatments.      Neuroaid is a Traditional Chinese Medicine which has been shown to stimulate growth of brain     cells and connections in animals. Neuroaid may improve blood flow in the brain and functional     recovery after stroke in patients. Neuroaid-II is a simplified formula with only the main 9     herbal ingredients of the original formula and no animal ingredients.      The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot     double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is     a 24-week, early phase trial of Neuroaid-II in patients who have thinking problems after     stroke. The study aims to investigate the effectiveness of the study drug in improving     cognitive performance. The safety of the study drug will be closely monitored using adverse     events, laboratory tests and vital signs.      The trial is important as it aims to set new standards for the scientific evaluation of Asian     Traditional Medicine for integration into standard medicine practice. It may potentially     establish a novel therapeutic approach for improving cognition after stroke.   "
109867|NCT01847911|"     The effect of a self directed video strategy will be compared to a face to face neonatal     resuscitation training program. The hypothesis is that both strategies are equivalent.   "
109868|NCT01847898|"     This is a randomized, controlled study to document and evaluate the clinical performance of     the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar     spine.      The randomized, controlled trial (RCT) will compare patients with VBS and Balloon     Kyphoplasty.   "
109869|NCT01847885|"     The purpose of this study is to determine if electrical stimulation (small levels of     electricity) reduces post-stroke shoulder pain. This study involves a device called the     Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles     in the shoulder. The Smartpatch System includes a small wire (called a Lead) that is placed     through the skin into the muscle of the shoulder. It also includes a device worn on the body     that delivers stimulation (called the Smartpatch Stimulator).   "
109870|NCT01847872|"     The overall goal of this study is to identify interference between intramuscular Inactivated     Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at     nine months of age and to confirm the safety of co-administration. In addition, the study     will compare the immunogenicity and safety of IPV when administered via different routes.      A total of 1504 healthy infants between the ages of nine to ten months, who have completed     their primary immunizations, including at least three doses of trivalent Oral Polio Vaccine     (tOPV) will be recruited for this study.   "
109871|NCT01847859|"     The investigators aim to study the feasibility and reliability of pocket-size diagnostic     ultrasound examinations performed by nurses of postoperative patients who have underwent     cardiothoracic surgery in a cardiac unit.   "
109872|NCT01847833|"     The goals of this study are to:        1. To improve upon and develop new innovative magnetic resonance imaging techniques that          refine image quality and enhance performance. Improvements in these areas will have          positive implications for medical diagnosis and treatment.        2. To correlate MRI images with underlying disease pathophysiology in order to ensure that          imaging accurately reflects the disease process.   "
109873|NCT01847820|"     To show that having less qualified personnel (non-Laboratory trained professionals) perform     the test yields the same result as if a Laboratory trained professional performed the test.   "
109880|NCT01847729|"     The aim of this study is to determine the current prevalence of co-addictions, including     problem/pathological gambling, in patients receiving Opiate Substitution Treatment (OST), and     to then compare patients receiving OST with or without a co-addiction (excluding tobacco     dependence) in order to determine their clinical profile.      In addition, an ancillary study to be carried out only among those patients receiving     methadone, will aim to etablish whether a low plasma concentration of methadone, on the one     hand, and an ultrarapid metabolizer genetic profile, on the other, are the characteristics     most commonly associated with the presence of co-addictions. This will allow us to complete     patient's pharmacological characterization.   "
109881|NCT01847716|"     Pulmonary arterial hypertension (PAH) is a disease that causes raised blood pressure in blood     vessels that pick up oxygen from the lungs. It has a life expectancy similar to some cancers.     There is treatment available but there is no cure. We now know that PAH is associated with     weakness in the muscles in the legs, which contributes to the symptoms patients' experience.     Researchers believe that certain proteins found in high levels in the blood of patients with     other chronic diseases can affect muscle function and growth. One of these proteins is called     growth differentiating factor (GDF) 8, high levels of which are associated with muscle     weakness in chronic obstructive pulmonary disease(COPD) and heart failure (HF). Interestingly     there are drugs available which block the actions of GDF-8 on muscle cells which has been     shown in animals to result in increased muscle size. A related protein called GDF-15 is found     in elevated levels in patients PAH, and is linked to prognosis. Our preliminary data suggests     that GDF-15 can also directly influence muscle size in a number of situations. We aim to     investigate the role of GDF-15 and related molecules in the development of muscle weakness in     patients with PAH. We will do this by measuring certain markers of muscle weakness and taking     blood and muscle samples in patients and controls. We will then compare the levels of GDF-15     in these tissues in those with and without muscle wasting. We hope this work will lead to a     greater understanding of the role of GDF-15 in the development of muscle weakness in patients     with PAH. GDF-15 levels may be important in allowing us to define which patients have muscle     weakness. In the future we aim to perform a clinical trial of drugs which block the actions     of GDF-15.   "
109882|NCT01847703|"     This study is intended to explore differences in oncologic and surgical safety between     robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial     cancer.   "
110151|NCT01844193|"     This study will examine the effects, if any, of using muscle stimulation on the quadriceps     following a total knee replacement. Secondary objectives will be to evaluate and compare pain     levels, qualitative outcomes, and the impact of NMES on pain medication requests between     groups. It is possible that strengthening the quadriceps muscles and improving their     activation will reduce postoperative pain and help patients return to activities sooner than     with standard therapy alone.   "
109883|NCT01847690|"     The conventional glucocorticoid replacement therapy in primary adrenal insufficiency-     Addison's disease,renders the cortisol levels unphysiological, which may cause symptoms and     long-term complications. Many patients take stress-doses that are extra doses of     hydrocortisone or cortisone acetate before or during stressful physical or psychological     events. However, the effect of such dosing has not been tested in scientific studies. In this     double blind cross-over designed pilot trial we aim to test the effect of an extra dose of     cortisol on physical activity and hormone levels.   "
109884|NCT01847677|"     Recently results have shown that Bevacizumab is active both in monotherapy and in combination     therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the     addition of neoadjuvant bevacizumab improves the response and whether this affects the     evolution of patients.   "
109885|NCT01847664|"     The purpose of the trial is to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs.     Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo in patients with acute uncomplicated     diverticulitis.   "
109886|NCT01847651|"     Patients with cirrhosis of the liver may suffer from a condition called hepatic     encephalopathy which in its mildest form as mental slowing and impaired reaction times in     driving and machinery operation. Left untreated it may lead to deep coma. The cause is not     fully understood but is though to be related to the inability of a damaged liver to filter     out toxins such as ammonia in the blood, which then accumulate within the brain and result in     altered function and swelling within certain brain cells,astrocytes. These patients also     suffer from muscle loss, which is associated with a poor outcome. L-ornithine     L-aspartate(LOLA) is a licensed drug in Germany and has been shown to promote ammonia     elimination from the body in the form of urea. Some experimental studies have suggested that     LOLA also potentially attenuates muscle loss by incorporating ammonia into muscle in the form     of glutamine. The aim of this study is to determine cognitive and nutritional effects of 12     weeks of LOLA administration and its effect on brain muscle structure and function in     patients with cirrhosis.   "
109887|NCT01847638|"     To investigate inflammation, visual acuity and macular thickness after treatment with     Prolensa vs Ilevro after cataract surgery.   "
109888|NCT01847625|"     The study will evaluate (in-vitro) the forces that are typically used for the extraction of     pacemaker or defibrillator electrodes.   "
109889|NCT01847612|"     The aim of the present study is to evaluate whether the use of indocyanine green fluorescent     cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver     diseases requiring liver resection.   "
109890|NCT01847599|"     The purpose of this study is to evaluate the efficacy of the implementation of an educational     program on adherence to capecitabine alone or in combination to lapatinib.   "
109891|NCT01847586|"     The purpose of this study is to determine if a novel brain stimulation approach using     magnetic stimulation (Transcranial Magnetic Stimulation [TMS]) can improve memory and     thinking processes in individuals with mild Alzheimer's disease (AD).   "
109892|NCT01847573|"     The main purpose of this study is to test the safety and tolerability of different,     increasing doses of an experimental medication called HT-100 in boys and young men with     Duchenne muscular dystrophy (DMD). The study medication, HT-100, is a medicine that may help     promote healthy muscle regeneration, diminish inflammation and the resulting damage to     muscle, and decrease the scar tissue that forms in the muscles of children with DMD. In this     study, pharmacokinetic sampling, or measurements of the amount of HT-100 in the bloodstream     will also be taken.   "
109893|NCT01847560|"     This study plans to describe utilization patterns for oral anticoagulants over time in     patients with non-valvular atrial fibrillation at risk for stroke using electronic claims     data from a United States commercial insurance database.   "
109951|NCT01846793|"     This study is designed to demonstrate the safety and efficacy of a second transrectal     intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH)     who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.   "
109895|NCT01847534|"     One of the essential treatments for assisting patients in their recovery from illness is the     provision of nutrition in a liquid form which is delivered into the stomach or as a fluid     into the vein. Until recently the benefits of nutrition were undervalued in the critically     ill, however, it has now become clear that targeted nutrition can positively affect a     person's outcome. This is particularly important for patients who are significantly unwell     and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy     leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly     contributes to their poor recovery.      Whilst nutrition is essential for recovery, there are several issues with the delivery of     nutrition via the stomach (the most commonly used method of delivering nutrition in the     critically ill). For many reasons, patients are unable to tolerate large quantities of     nutrition via the stomach and in addition to this there are hospital or procedural reasons     for nutrition being turned off for lengthy periods of time. As such, this results in patients     being delivered only about half of the nutrition that is planned. One potential way to     overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach     continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the     stomach.      In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in     50 patients and the other 50 patients will receive nutrition as per normal practice. We will     measure important outcomes for these patients to determine if this allows us to meet     significantly more of their nutrition needs. This study will also help us determine how best     to design a larger study of this strategy.   "
109896|NCT01847521|"     Background. Increasing evidence indicates that brain inflammation is important in the     pathogenesis of neuropsychiatric disorders, including at least a significant proportion of     subjects with Autism spectrum disorder (ASD). Natural flavonoids, such as luteolin and     quercetin, exhibit potent antioxidant and anti-inflammatory activities, inhibit the release     of inflammatory mediators from human mast cells, and reduce maternal interleukin 6-induced     autism-like behavioral deficits related to social interactions in mice. In a case series of     37 children with ASD who took a dietary supplement containing luteolin and quercetin for 4     months reported gains in eye contact, attention and social interaction according to parental     reports.      Aim. The purpose of this study was to assess the effectiveness and tolerability in white     children with ASD of a dietary supplement containing 2 flavonoids, luteolin and quercetin,     and the quercetin glycoside rutin.      Methods. Fifty children (42 boys and 8 girls) divided into 2 equal age groups (4-6 years old,     and 7-10 years) with ASD were enrolled in a 26-week, prospective, open-label trial at the 2nd     University Department of Psychiatry at Attikon General Hospital, Athens, Greece, the Ethics     Committee of which approved the study. The parents of all subjects were informed of the     study's aims, including risks versus benefits of participating and not participating as well     as the inclusion and exclusion criteria, and they written consent for participation in the     study.      Participants had already been diagnosed with ASD based on clinical assessments, and this     diagnosis was corroborated at the 'Attikon' clinic by meeting the cutoff scores on both the     DSM-IV-TR, symptom list and the ADOS algorithm. All children were medication naive. Apart     from the diagnostic evaluation, the assessment also included a thorough medical evaluation     comprising a physical examination and health history (including a review of allergic and     gastrointestinal symptoms, as well as any food allergies or food intolerance). All concurrent     interventions were thoroughly noted (type and hours), and the same was done at all visits.     After meeting screening criteria, subjects were evaluated at the baseline visit, mid-trial     visit at 18 weeks, and final visit at 26 weeks.      Children were administered a dietary formulation containing 2 flavonoids, luteolin (100     mg/capsule) and quercetin (70 mg/capsule), and the quercetin glycoside rutin (30 mg/capsule).     The dose used was 1 softgel capsule per 10 kg (22 lb) weight per day with food for 26 weeks.      The primary outcomes were the age-equivalent scores in the 3 domains of the Vineland Adaptive     Behavior Scales (VABS), communication, daily living skills, and socialization. The VABS was     chosen because the impact of an agent on adaptive functioning in real life is even more     important for obtaining a better quality of life than just alleviation of some symptoms. The     raw scores from the interview can be also expressed as an age-equivalent score and a standard     score compared with those of the subject's peers. There are also supplementary special norms     for individuals with autism. Although standard scores could be more useful in subject     characterization, their use as an outcome measure has been proven to be less sensitive due to     floor effects and reduced variability, especially in short time periods, and thus these     scores underestimate change. Conversely, scores of special norms tend to overestimate change,     as a small increase in a raw score can produce a big improvement in special norm percentile     rank. Thus, raw scores and age-equivalent scores seem to be the most appropriate for use as     outcome measures, with the latter being more easily interpreted as change over time.      Secondary outcomes included the Aberrant Behavior Checklist (ABC), the Autism Treatment     Evaluation Checklist (ATEC), and the Clinical Global Impression-Improvement score (CGI-I). To     explore other possible effects of the formulation not captured from the aforementioned     instruments, we chose to record any other benefits observed and reported by the parents     during its use. For this, the primary clinician (K.F.) conducted telephone or in-person     interviews of the parents, independently of the assessing clinician (A.T.), to discuss the     possible gains of the child. CGI-I was also independently coded by the primary clinician with     personal assessments as well as with information gathered by parents and, in the majority of     cases, by the subjects' trainers.      Compliance was monitored by softgel capsule count and the parents' assurance that the     capsules had actually been taken at each visit; in case of a capsule count <85% of the     prescribed dosage at midterm and at the end of the study, the subject was excluded from the     final analysis.      Adverse events were systematically recorded on an adverse event form by using scales     indicating severity, relationship to the study procedures, action taken, and any therapy     required.   "
109897|NCT01847508|"     The primary objective is to compare the mechanical failure risks in the first year after     treatment.   "
110016|NCT01845948|"     This study tested the effectiveness of a parental training programme to enhance parent-child     relationship and reduce harsh parenting practices and parental stress in the preparation of     children for transition to primary school. A randomized controlled trial was employed and 142     parents were recruited. Parents in the experimental group engaged in less harsh parenting     practices and reported better parent-child relationships than parents in the control group.     Findings from this study provide empirical evidence of the effectiveness of the parental     training programme and highlight the significance of parental involvement in promoting a     smooth transition for children from kindergarten to primary one.   "
109898|NCT01847495|"     The purpose of this study is to determine the effects of CyberKnife stereotactic body     radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal     cancer that has spread to the liver.      Conventional radiation therapy has a limited role in the treatment of patients with liver     metastases because the radiation doses are limited by liver toxicity. The CyberKnife system     is a type of radiation machine that precisely focuses large doses of x-rays on the tumor, so     that injury from radiation to the nearby normal tissue will be minimal. It is approved by the     U.S. Food and Drug Administration to treat tumors, lesions and conditions anywhere in the     body when radiation therapy is required. While the device is no longer classified as     investigational, the best treatment dose and times are still being evaluated.      Chemotherapy delivered with radiation therapy can increase the effectiveness of treatment,     and may allow for a lower dose of radiation therapy to be utilized, thereby limiting negative     side effects.      In this study, patients will receive Cyberknife radiosurgery directed to liver metastasis for     3-5 treatments, given every other day. Irinotecan 40mg/m2 will be administered intravenously     daily for 3-5 days (5 treatments within 10 elapsed days), and prior to radiation therapy.     Patients will have follow-up visits at months 1,2,4,6,9,12,15,18, 24, 30, 36, and every 6     months thereafter for 3 years.   "
109899|NCT01847482|"     A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic     hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac     arrest, post-return of spontaneous circulation (ROSC) patients in Japan.      The objective of this study is to verify that therapeutic hypothermia performed by     intravascular cooling using the investigational device (IVTM) can control body temperature     appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.   "
109900|NCT01847469|"     This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress     disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive     either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization     will be done using 3:1 ratio and will be performed by our research pharmacy using a random     assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo.     Medication will be titrated over a 6 week titration phase followed by a 6 week treatment     phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will     be provided by trained and qualified clinicians with extensive experience providing E-CPT-C.     Veterans will be recruited primarily through advertisement, but also through the clinical     facilities at the VA and from other collaborators.   "
109901|NCT01847456|"     The researchers will investigate if brain insulin action influences peripheral insulin     sensitivity in healthy humans.   "
109902|NCT01847443|"     The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess     the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the     reference nicotine gums (2 mg and 4 mg) in healthy smokers.   "
109903|NCT01847430|"     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B     in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The     study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these     subjects.   "
109904|NCT01847417|"     An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over,     single dose, comparative bioavailability pilot study under fed conditions. For fed condition,     after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories)     after which they will be required to fast overnight (for at least 10 hours). Thereafter they     will receive a non-vegetarian high calorie, high-fat breakfast (800-1000 calories) before     dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and dinner.   "
109905|NCT01847404|"     An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over,     single dose, comparative bioavailability pilot study under fasting conditions. The treatments     will be administered after an overnight fasting of at least 10 hours in each period. Fasting     will continue for four hours post-dose, and then meals will be provided at specified     intervals. Drinking water will not be permitted one hour before dosing and until one hour     post-dose.   "
109906|NCT01847391|"     This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose     study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy     subjects.   "
110453|NCT01840254|"     The aim of this study is to test the hypothesis that addition of dexmedetomidine to     fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl     bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing     lumbar spine surgery.   "
109907|NCT01847378|"     Ventricular tachycardia is one of the commonest cause of sudden death in chronic chagas     disease. As most ventricular tachycardias originate from scar in patients with heart disease,     catheter ablation is an important step in patient treatment. Identification of fibrosis prior     to ablation of sustained ventricular tachycardia (SVT) might reduce the time of anesthesia,     procedure time, radiation exposure and possibly the risk of complications. Knowledge of     arrhythmia circuit within scar allows planning strategies for each procedure. Condreanu et     al. stablished that voltages inferior to 6.52 mV (unipolar) and 1.54mV (bipolar) are useful     tools in detecting scar during electroanatomic mapping. Accuracy, however when compared to     magnetic resonance imaging is limited due to difficulties in maintaining good contact between     ablation catheter and ventricular wall. Contact force catheters might help increase accuracy     of voltage mapping because they allow detection of poor contact areas. Although the threshold     for identification of scar in ischemic and non ischemic patients during electroanatomical     mapping is already known, this parameters still lacking for chronic chagasic individuals. A     marked qualitative histological difference between these fibrous scars supports the     hypothesis that voltage scar in chagasics might be different. Catheter ablation contact with     endo and epicardial surface is an important issue when ablating arrhythmias. Conventional     catheter ablation is not equipped with sensors capable of detecting degree of contact with     the target. To our knowledge, the literature lacks information in regard to late lesions     produced by a known contact force pressure in vivo. The pattern of electrical activation in     these patients and their relationship with local coronary veins for resynchronization likely     to approach through the coronary sinus can be useful in defining chagasic that can benefit     from resynchronization.        1. Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on          3T MRI        2. Correlate areas of late activation within scar during activating mapping in sinus rhythm          with different signal intensity in 3T MRI        3. Evaluate the influence of contact pressure during application of radiofrequency in          making fibrosis analyzed 30 days after the procedure using a 3T MRI.        4. Assess the site of latest left ventricular activation in sinus rhythm and correlate with          the coronary veins location   "
110017|NCT01845935|"     To now, two alternatives for the management of venous vascular malformations are recognized,     appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is     effective on symptoms in 80% of cases and excision removes the malformation completely or     partially, but it is aggressive and recurrences are common.   "
109908|NCT01847365|"     Retinitis pigmentosa (RP) is a progressive degenerative disease of the retina, which often     leads to blindness. 1 in 4000 people in the UK are affected by RP yet there is no established     therapy for treating or delaying its progression.      Transcorneal electrical stimulation (TES) has garnered attention as a possible therapeutic     option for RP. Research has shown that TES improves retinal cell viability and visual     function. An initial pilot study of TES on 24 participants with RP demonstrated that it was     safe and improved vision.      This study aims to confirm the safety of the new CE-approved Okustim device and to further     characterise the benefits of TES on a larger scale. 12 participants will be enrolled for 1     year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital.      Recruited participants will undergo weekly TES of 1 eye for 30 minutes for a period of 6     months. This will be followed by a further 6 months of observation without stimulation giving     a total participation time of 1 year. Participants will be assessed at 3, 6, 9 and 12 months     after their initial baseline visit by clinical examination, investigations and     questionnaires.      Participants should have a diagnosis of RP and be capable of giving consent. Participants, or     a carer, should have sufficient motor skills to attach the device themselves. As this study     seeks to ascertain the impact of TES on RP, participants with other eye diseases (e.g.     diabetic retinopathy) cannot be included in the study.   "
109909|NCT01847352|"     On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic     blood pressure (PASP, blood pressure through the lungs) to increase. We have previously shown     that raising iron by giving an infusion of iron into a vein reduces this pressure rise and     that lowering iron by giving a drug that binds iron, magnifies this response. This is     potentially a clinically important observation since iron-deficient people may be at     increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia due     to lung disease or residence at high altitude; furthermore if this were true then intravenous     iron could be an important treatment in this patient group in the event of hypoxic exposure.     The observed effects of iron on PASP are likely to be because iron levels affect oxygen     sensing. Low iron levels make the body behave as if exposed to low oxygen by inhibiting the     breakdown of the family of oxygen-sensing transcription factors, 'hypoxia inducible factor'     or HIF. This includes one of the body's normal responses to low oxygen levels - raising blood     pressure through the lungs.      This study will answer the question (1) do iron-deficient volunteers have a greater rise in     PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron cause     a greater reduction in the rise in PASP in those who are iron-deficient than iron-replete?     The purpose of this study is not to test the safety or clinical efficacy of iron which is     already known.   "
109910|NCT01847339|"     The effective relief of pain is of paramount importance to anyone treating patients     undergoing surgery. Post-operative pain increases the possibility of post-surgical     complications, raises the cost of medical care, and most importantly, interferes with     recovery and return to normal activities of daily living. Therefore pain control is essential     in the management of patients undergoing spinal surgery.Parenteral administration of     narcotics has been the mainstay for postoperative pain relief in patients undergoing     laminectomy and discectomy. Epidural and intrathecal opioids are also effective means of pain     control in several major surgical interventions including spinal surgery. However, some of     the side effects have limited their widespread use (eg, late-onset respiratory depression).     Therefore, alternative measures of pain control including infiltration of paraspinal     musculature with local anesthetics have been investigated with conflicting results. In     situations such as laminectomies, where the epidural space is exposed as part of the surgical     procedure, the application of absorbable gelatin sponge soaked in local anesthetics appears     to be an alternative for providing postoperative analgesia. By investigating the probable     analgesic effects of this method the investigators may relieve post laminectomy pain with     minimal side effects and also costs.   "
109911|NCT01847326|"     This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized     nanoparticle formulation when given together with carboplatin followed by chemoradiation in     treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as     paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and     hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill     tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by     chemoradiation therapy may be an effective treatment for head and neck cancer.   "
109952|NCT01846780|"     Patients with unilateral post-thrombotic obstruction of the iliac tract and or common femoral     vein, eligible for stenting are included. Intravenous pressure is measured in both dorsal     foot veins and both common femoral veins. Patients are asked to undergo a standardised     treadmill test (3.2km/h, 0% slope that increases by 2%/2min, maximum walking time 26 min).     Painfree and maximum action radius are noted.   "
109953|NCT01846767|"     The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in     type 2 diabetic patients.   "
109912|NCT01847313|"     Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst     form, can lead to early cardiovascular death or kidney failure. A group of medicines used to     treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with     diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory     by studying the effect of GLP-1 on kidney function in people with diabetes.      To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1     treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney     function using blood and urine tests. The investigators will compare these results to     patients with DKD who do not receive GLP-1 treatment.      If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then     it could be developed as a viable new treatment for people with DKD, and may significantly     reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major     advance in the treatment of DKD.   "
110028|NCT01845792|"     Patients are being asked to take place in this research study because they have advanced     prostate cancer that has gotten worse after other treatments. If they join this study they     will receive a new combination of drugs that are used to treat prostate cancer.   "
110152|NCT01844180|"     The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in     female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).   "
109913|NCT01847300|"     The goal of this project is to test the efficacy of a computer-facilitated Screening and     Brief Intervention system adapted for Military use (cSBI-M) in reducing substance use among     18- to 25-yr-old U.S. Navy and U.S. Marine Corps personnel (USN/USMCs). The aims and     hypotheses of this project are to: 1)Test the effects of cSBI-M on any alcohol use.     Hypothesis: Among 18- to 25-yr-old USN/USMCs coming for routine health screenings, those     receiving cSBI-M will have lower rates of any alcohol use at follow-ups compared to TAU. 2)     Test the effects of cSBI-M separately as a preventive, early therapeutic, and risk-reduction     intervention. Hypotheses: (a) Among 18- to 25-yr-old non-drinking USN/USMCs (negative history     of past-12-months drinking at baseline), those receiving cSBI-M will have lower rates of     drinking initiation and heavy episodic drinking (HED, a.k.a. binge drinking). (b) Among 18-     to 25-yr-old drinking USN/USMCs, those receiving cSBI-M will have higher rates of drinking     cessation, reduced intensity of drinking (e.g., past-3-months drinking days, HED, and driving     after drinking or riding with a drinking driver.(3) Test the effects of cSBI-M on tobacco     use; explore its effects on other drug use. (4) Assess potential moderators (e.g., age,     gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use),     mediators (e.g., Patient to Provider Connectedness,17 perceived harmfulness of alcohol and     drug use), and explore cSBI-M's mechanism of action. Hypotheses: among 12- to 18-yr-old     patients coming for routine care, those receiving c-ASBI will have 1) lower rates of any     alcohol use, of drinking initiation and riding with a driver who has been drinking, and 2)     higher rates of drinking cessation, reduced intensity of drinking, heavy episodic drinking     and driving after drinking or riding with a driver who has been drinking.   "
109914|NCT01847287|"     The primary aim of this study is to evaluate the effect of using Tysabri on changes in the     brain using MRI and on disease progression in patients with relapsing-remitting Multiple     Sclerosis over 5 years.   "
109915|NCT01847274|"     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of     niraparib as maintenance in platinum sensitive ovarian cancer patients who have either     gBRCAmut or a tumor with high-grade serous histology and who have responded to their most     recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP     inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously     during a 28-day cycle. Health-related quality of life will be measured by the Functional     Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale,     5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be     assessed by clinical review of adverse events (AEs), physical examinations,     electrocardiograms (ECGs), and safety laboratory values.      The primary objective of this study is to evaluate efficacy of niraparib as maintenance     therapy in patients who have platinum sensitive ovarian cancer as assessed by the     prolongation of progression free survival (PFS).   "
109916|NCT01847261|"     During aging there is a tendency for muscle protein synthesis (growth) to become less     efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can     affect strength and mobility. Protein consumption may be one opportunity to alleviate this     problem especially when consumed in appropriate amounts following resistance training. This     study is designed to determine if a soy dairy protein blend, shown to be effective in younger     adults, will produce beneficial muscle protein synthesis in older healthy adults following     resistance exercise.   "
109917|NCT01847248|"     -  Molecules indicating endothelial injury may serve as biomarkers for severe sepsis          because of the critical role of endothelial injury in organ dysfunction during severe          sepsis.        -  HSPA12B is primarily located in endothelial cells and detectable during sepsis.        -  The investigators speculated that HSPA12B from endothelial cells might be correlated          with severe sepsis.   "
109918|NCT01847235|"     The purpose of this study is to determine the efficacy and safety of temozolomide in patient     with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.   "
109919|NCT01847222|"     Safety assessment of SANGUINATE™ in Healthy Volunteers.   "
109920|NCT01847209|"     This is a phase II protocol to determine the safety and feasibility of Intraoperative CT     fluoroscopy guidance for lung resection for small nodules.   "
109921|NCT01847196|"     The primary objective of this clinical trial is to obtain initial insights into the safety of     the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE)     disease AND who are not receiving pharmacological thromboprophylaxis.   "
109922|NCT01847183|"     The purpose of this research is to create and evaluate the efficacy of an exciting (fun to     use), and potentially disseminable computer-based prevention program, Click City®: Alcohol,     for use by 7th graders with a booster in 8th grade students. The ultimate goal of Click     City®: Alcohol is to prevent the onset of heavy drinking during high school and post-high     school. Secondary goals of the program include decreasing students' intentions and     willingness to engage in heavy drinking in high school. The proposed program is unique both     in its delivery system and the development process.      Aim 1: The investigators plan to develop and test approximately 24 components over the first     two years of the study.      Aim 2: The final Click City®: Alcohol program will consist of 12 effective components     delivered in six sessions over a three-week period in 7th grade. This is followed by two     booster sessions, consisting of a total of 5 components delivered over a one-week period in     8th grade. Educational newsletters to parents and teacher guides will accompany the program.      Aim 3: Following development, the investigators will conduct a group randomized trial to     evaluate the efficacy of this program as compared to schools' usual alcohol prevention     curriculum. The investigators plan to recruit, stratify and randomly assign 26 middle schools     to one of the two conditions, Click City®: Alcohol and Usual Curriculum (UC). Students in the     Click City®: Alcohol and yoked UC schools will be assessed prior to the beginning of the 7th     grade program, following the 7th grade program, following the 8th grade booster, which would     occur approximately one year after the 7th grade program, and a follow-up assessment in the     9th grade to assess long-term outcomes, one year after the 8th grade assessment.   "
109923|NCT01847170|"     The human immune system is usually tolerant of the millions of beneficial commensal bacteria     (the microbiome), which colonize the healthy intestinal tract. In contrast, patients with     Inflammatory Bowel Disease (IBD) may play host to an imbalanced mix of such intestinal     bacteria, which initiates abnormal immune responses in susceptible individuals. The resulting     inflammation that occurs in the gastrointestinal tract damages the intestinal lining, leading     to symptoms (such as intractable diarrhea, pain or weight loss), heightened cancer risk,     other serious complications with substantial morbidity and even death. Current therapies for     IBD focus on suppressing the excessive immune response to these bacteria, but have major side     effects and do not address any role of the microbiome in disease development.      The investigators hypothesize that there is heightened intraluminal generation of     pro-inflammatory factors by luminal pathogenic bacteria, such as extracellular nucleotides     and purinergic derivatives, which trigger host immune cells. This results in loss of     suppressive T regulatory cells with unrestrained immune cell deviation to pathogenic T helper     cells that cause inflammatory responses. The investigators' proposal is that correcting the     disease-provoking microbiome would beneficially improve gut microbial diversity, alter immune     responses elicited in patients by such microbial products of pathogenic bacteria, and     ultimately limit and suppress disease activity.      To test the hypothesis, the investigators propose to enroll patients with active Crohn's     Disease, and introduce the microbiome of healthy and unrelated individuals to patient's     intestinal tract, via fecal biotherapy (FBT) with all applicable safety measures. The     investigators propose to comprehensively test the effects of FBT on the host microbiome,     determine microbial production of inflammatory nucleotides and derivatives, which the     investigators suggest might impact the host immune response and disease activity in patients     with IBD.   "
109925|NCT01847144|"     Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have     little effect in one person but a large effect in another. Understanding mechanisms of     altered response to treatment could aid treatment selection and assist the design of new     medications with lower nonresponse rates.      This study will examine the physiological mechanisms and potential clinical/biomarker     predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering     medication and answer fundamental methodological questions for the future study of variation     in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy     for up to 2 weeks with assessment of baseline characteristics and glycaemic response.     Participants will then enter an optional extension where they receive sulphonylurea or DPPIV     inhibitor therapy in crossover fashion.   "
109926|NCT01847131|"     Background Allergic rhinitis is a common health problem with a worldwide prevalence is     10-25%, and poses significant impact on the quality of life of the patients. In Thailand, the     prevalence of allergic rhinitis in the general population is 13.5%, of which the frequency of     allergic rhinitis increased from 23% to 38% in the children, and 61.9% in the graduate     students. Despite intranasal steroid being the current first-line treatment of patients with     allergic rhinitis, only 60% of patients achieve excellent control. Persistent nasal     congestion is the major symptom which is difficult to control in these patients. Data are     limited about efficacy and safety of the additional use of 0.05% intranasal oxymetazoline     hydrochloride (OXY) for persistent nasal congestion that does not adequately respond to     recommended doses of intranasal steroid (INS) and oral antihistamine(OAH).      Objective To determine the efficacy and safety of the additional use of OXY for persistent     nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately     controlled by combination treatment with INS and OAH.      Methods The investigators performed a 6-week, randomized, double blind, placebo controlled,     clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom     inadequately controlled by combination treatment with INS and oral antihistamine (OAH). After     an initial screening, qualified individuals were randomized into 2 groups including the     treatment group and the control group. The treatment group received the INS (2 puffs in each     nostril twice daily) and OAH (1 tablet once daily) plus OXY (2 puffs in each nostril twice     daily) The control group received INS (2 puffs in each nostril twice daily) and OAH (1 tablet     once daily) plus placebo (2 puffs in each nostril twice daily).   "
109927|NCT01847118|"     This study is to assess the safety, tolerability and pharmacokinetics of single dose and     multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with     advanced or metastatic solid tumors. The secondary objective is to explore the preliminary     anti-tumor effects.   "
109928|NCT01847105|"     Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).   "
109929|NCT01847092|"     The purpose of this study is to determine if the study drug is safe, tolerable and active in     reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.   "
109930|NCT01847079|"     PROBIC      Rationale: Procalcitonin measurements can reduce the number of blood cultures in the ICU.      Objective: The investigators suggest that PCT is a marker for blood stream infection in all     patients in the ICU in whom attending physicians/ intensivists order blood culturing in the     suspicion of microbial infection. The investigators want to demonstrate that its use for     guiding blood culturing is cost-effective and safe compared with blood cultures alone.      Study design: Prospective, non- inferiority, multicenter, single-blinded, cluster- randomised     cross-over clinical trial.      Intervention (if applicable): The intensive care units will be allocated into two groups: a     control group (blood culture) and the intervention group (procalcitonin).      Main study parameters/endpoints: Safety, expressed as mortality at day 28 and 90, with a     mortality difference not exceeding a between groups difference of 10% by non-inferiority     analysis.      Cost-effectiveness, expressed in euro, calculated by deducting costs of procalcitonin testing     from saved blood cultures compared with standard treatment spending on blood cultures in the     control group.      ICIS      Rationale: The aim was to evaluate the Intensive Care Infection Score (ICIS) in predicting     microbial infection and its sequelae in critically ill patients in whom attending physicians/     intensivists order blood culturing in the suspicion of microbial infection.      Objective: Because of the complexity of the pathophysiology of systemic inflammation it is     unlikely that a single parameter will have sufficient diagnostic accuracy for infection.     Therefore we will study combining parameters producing a diagnostic score.      Study design: Prospective, multicenter, cohort trial. Supplement for the control arm of the     ProBIC study.      Intervention (if applicable): Blood is drawn for daily routine laboratory measurements and     collected in K3EDTA aliqnots. The ICIS score is composed of five blood-cell derived     parameters which can be extracted using the same aliqnots.      Main study parameters/endpoints: To develop and evaluate a blood- cell derived score to     enable the diagnosis of microbial infection, its likelihood, its invasiveness and severity.   "
109931|NCT01847066|"     To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the     US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and     pigmented skin.   "
109932|NCT01847053|"     A partial double-blind, randomized, placebo-controlled, 4-treatment crossover study design     will be used to evaluate bioavailability of various forms of cinnamon and to determine the     effects of 3 and 6 g of cinnamon added to instant oatmeal on blood glucose levels in 8     healthy subjects. In the extended dose response study, three subjects will continue the study     and be offered 5 day consecutive feedings of 9 g cinnamon extract and on Day 6, and blood     samples would be collected over 6 hours after a single morning dose. Urinary samples would be     collected upon to 48 hours.   "
110454|NCT01840241|"     In this single-site, randomized, controlled and double-blind clinical trial, the     investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury     in high risk patients undergoing off pump coronary bypass surgery.   "
109933|NCT01847040|"     The study will provide evidence on the long term outcomes of mTBI in service members     returning from Afghanistan and Iraq. In addition, the study will provide evidence on mTBI     incidence, and symptom patterns. Self-reported assessments at baseline and follow-ups will be     combined with data on health care utilization and military job performance. The work,     symptoms, and family interaction outcomes of returning soldiers screening positive for mTBI,     combined mTBI and PTSD, and soldier controls will be compared at 3 months, 6 months, and at     one year. The assessments over time will permit descriptions of symptom changes for these     populations. It is likely the study will find similar findings to those of previous civilian     studies - that concussive symptoms often resolve within months of injury. However, some     soldier subsets may have chronic problems. Determining the incidence and outcomes of     individuals with mTBI will assist medical providers in determining the types of follow-ups     needed by returning service members and suggest the development of additional treatment     interventions. These results may also inform treatment of civilian populations with mTBI.      The three primary hypotheses are:        1. Concussive symptoms at the time of return from serving in Afghanistan and Iraq and          symptoms persisting 3 months, 6 months, and 12 months after return will be associated          with extent of exposure to combat, injury mechanism, associated injuries (co-occuring          injuries), PTSD and other psychiatric co-morbidities, and number of deployment-related          mTBIs.        2. Returning troops reporting concussive symptoms at the time of return from deployment          will have more work related problems at each follow-up (including lower rates of return          to duty, return to work, and poor quality of work).        3. The mTBI screening tool will be sensitive and specific to mTBI when compared to the          criterion measure, which is a structured interview conducted by clinicians blinded to          the screening results.   "
136692|NCT01495533|"     The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis     with a drug coated AngioSculpt scoring balloon.   "
109937|NCT01846988|"     The purpose of this research study is to determine if auto-adjustable positive airway     pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP     is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to     the upper airway (nose and throat) to keep the airway from collapsing while during sleep. The     difference is that APAP adjusts the pressure throughout the night with changes in resistance     during breathing, and CPAP gives the same amount of pressure the whole time it is worn. APAP     is currently widely used to treat adults with OSA, however, this device has not yet been     extensively studied in children.      There are two parts to this research study. Subjects will begin using APAP at the time of     enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the APAP     device over the 4-8 weeks with the pressure determined by a CPAP titration study. The     titration study is a second overnight sleep study that is routinely ordered when a child with     sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be used.      In the second part of this study The investigators will compare the effects of APAP with CPAP     to see what is reported as more comfortable and is used during more hours of sleep. This part     of the study will last about 8 weeks and each subject will use both CPAP and APAP for 4 weeks     each.      Currently when someone is diagnosed with OSA there is a delay in starting treatment with CPAP     until the results of the titration study are available. In this research, patients could be     allowed to immediately start treatment with APAP. If APAP is found to be as safe and     effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.   "
109938|NCT01846975|"     RA (rheumatoid arthritis) patients effectively treated weekly with SC (subcutaneous)     Abatacept will be switched to IV (intravenous) Abatacept and restarted with SC Abatacept four     after IV application. The investigators hypothesize that a switch from SC- to IV-abatacept     and back in patients with low disease activity is safe and not associated with a worsening of     the disease.   "
109939|NCT01846962|"     Therapeutic strategies for eosinophilic esophagitis (EoE) actually include: 1) allergen     avoidance through dietary modifications, and 2) pharmacologic antiinflammatory therapy.     Medical treatment is mainly based on topical administration of corticosteroids by swallowing     fluticasone propionate or budesonide spray. Dietetic treatment with highest efficacy is     elemental diet, consisting in exclusive feeding with amino-acid based formulas, often     administered trough SNG. Alternative choices of acceptable efficacy are empirical six-foods     elimination diet (cow's milk, egg, soy, wheat, peanuts, fish) and targeted elimination diet     based on the results of allergy tests. Most of the paediatric patients with EE respond to     elemental or targeted elimination diets, and therefore such authors recommend elimination     diets to be considered the treatment of choice in children. However, elimination diets can     often be complex to follow and may be associated with poor adherence owing to the low     palatability of a highly restricted diet. In non-compliant patients, especially in     adolescents and young adults, it may be more practical to proceed first with corticosteroid     treatment. In the case of partial response to elimination diets or corticosteroids, a     combination of both treatment mod. However, there has been limited testing of these regimens     in randomized controlled trials, while most of available literature is based on case series.      The aim of this study was to compare the efficacy of six-foods elimination diet versus     swallowed fluticasone versus budesonide in pediatric patients with active EoE. The     investigators assessed the effects of randomly assigned treatment on clinical and     endoscopic/histologic severity as primary and secondary outcomes, respectively. In addiction,     we assessed the efficacy of combined therapy (diet plus topical steroids) administered to non     responding patients. The investigators describe clinical, allergological, endoscopic and     histological features, and pH study results, of our pediatric population.   "
110023|NCT01845857|"     This survey will address important research, practice, and policy questions: How does Chronic     Disease Self-Management Program (CDSMP) impact participants' general health, their health     behaviors, and their need for health care utilization? Who benefits most from the CDSMP     program? Are predicted gains maintained over a six and twelve month period? Can critical     clinical changes be seen for those who are diabetic?   "
109940|NCT01846949|"     This study is intended to be a prospective observational study at multiple sites, not a     randomized controlled trial (RCT). The uses of the biomarkers has been approved by government     regulations and adopted for surveillance programs in some countries, thus an RCT which     compares patients followed by US alone with patients followed by both US and the biomarkers     would raise an ethical conflict, especially in countries where the biomarkers have been     routinely used.      For this study, enrolled patients will be followed by US and the biomarkers at regular     intervals and classified after completing the study to evaluate the clinical effectiveness of     the biomarkers. The comparisons of sensitivity, specificity, and other parameters with     respect to tumor characteristics will be made among US alone, the biomarkers, and combined     use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be     investigated in this study.   "
109941|NCT01846936|"     One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial     blocker (BB). In this study, the investigators compared the effectiveness of lung collapse     using DLT, BB with spontaneous collapse, and BB with disconnection technique.   "
109942|NCT01846923|"     The purpose of this study is to determine whether one dose of the 13-valent pneumococcal     conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether     previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine     influence the cellular immune response to PCV13 in this group.   "
109943|NCT01846910|"     The objectives of this study are:        1. To determine the effect that an intensive, community dental clinic centered,          stop-smoking program using a motivational interviewing approach has upon cessation rates          for interested, smoking inner-city dental patients.        2. To determine the effect that providing a tooth whitening incentive, in a community          dental clinic stop-smoking program, has upon cessation rates for interested, smoking          inner-city dental patients.   "
109944|NCT01846884|"     To collect and process urine samples from critically ill subjects for use in assessing the     effects of various urine sample freezing and storage conditions on biomarker test results.   "
109945|NCT01846871|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the study drug tivozanib is still being studied. It also means     that the FDA has not yet approved tivozanib for your type of cancer.      Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking     the blood supply to the tumor, so that the tumor does not receive the nutrients it requires     to grow.      In this research study, we are looking to see what effects, good and bad, tivozanib will have     on you and your disease.   "
111014|NCT01832883|"     The purpose of this project is to compare the performance of the Pediatric Vision Scanner     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at     detecting amblyopia and strabismus.   "
109946|NCT01846858|"     Vaginal cuff dehiscence, a rare complication of gynecologic surgeries, can be devastating,     particularly when associated with bowel evisceration. A review of records from 1970 - 2001 at     the Mayo Clinic in Rochester, MN revealed a low incidence (0.032%) of vaginal cuff dehiscence     after pelvic operation via both abdominal and vaginal approaches3. At a single, large,     tertiary care facility, total laparoscopic hysterectomy (TLH) was associated with an     increased incidence of vaginal cuff dehiscence compared to other approaches (4.93% vs. 0.29%     TVH, and 0.12% TAH)1. A review of our robotic experience revealed a vaginal cuff dehiscence     incidence of 4.1%, which is comparable to the previously reported incidence for TLH2. An     increasing number of laparoscopic hysterectomies are being performed in the United States     with the rate of laparoscopic procedures increasing from 0.3% in 1990 to 11.8% in 20034. With     11.8% of 600,000 annual hysterectomies being performed via the laparoscopic route in the     United States, there would be an estimated 3,400 cases of vaginal cuff dehiscence per year.      The cause of the higher rate of vaginal cuff dehiscence in both laparoscopic and robotic     hysterectomies is currently unknown. One of the major differences between the laparoscopic     and robotic approach as compared to the vaginal/abdominal route is the method by which the     cervix is amputated from the vagina. With the vaginal and abdominal approaches, a colpotomy     is made sharply with a knife or scissors. In contrast, the colpotomy is performed with     electrocoagulation with the laparoscopic and robotic routes. One theory to explain the     increased dehiscence incidence is the lateral thermal effects of electrocoagulation on the     vaginal cuff which may adversely affect tissue healing.      This study aims primarily to shed light on the etiology of vaginal cuff healing after a     robotic total hysterectomy. This will be done by comparing the extent of thermal injury at     the cellular level using monopolar vs CO2 laser at the time of the colpotomy.   "
109947|NCT01846845|"     The purpose of the study is to evaluate residual limb circulation and skin health associated     with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will     be compared to the novel transfemoral socket system.   "
109948|NCT01846832|"     The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks     of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV)     in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C     Virus (HCV) infection.   "
109949|NCT01846819|"     100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a     comprehensive clinical evaluation for severity of liver disease, anemia, depression, and     fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the     6-minute walk test (6MWT), a standardized exercise test that measures the distance that a     patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using three     well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and the     Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to     select the factors that potentially are associated with the scores as indicated by a P value     <.20; the selected factors will then be entered in a stepwise regression to create a     multivariate model giving the combination of factors that are significantly associated with     the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the model     in order to test its significance while controlling for the other factors.   "
109950|NCT01846806|"     This is a prospective study designed to examine the role of bacterial overgrowth and delayed     intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study     is divided into Phase A and Phase B. The purpose of Phase A is to test patients with     cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal     transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the     improvement found in patients with hepatic encephalopathy taking Rifaximin is also related to     decreased bacterial overgrowth.      Subjects' mental capacity will be assessed at each visit via interview, brief mental status,     questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to     continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness,     concentration, or understanding of evaluation, will be discontinued from the study. Female     subjects of childbearing potential will be asked to comply with the use of contraception     during the Phase B study period as well as throughout the time they remain on study drug.   "
109954|NCT01846754|"     The prevalence of end stage renal disease in Taiwan was listed first all over the world.     Fatigue, which makes patients unable to be competitive to play their functional roles, is one     of the most bothersome symptoms of patients receiving long-term hemodialysis. Tracing back to     the development of its relating studies, there is no accurate reason that why does people     undergoing hemodialysis feel fatigued. Conclusive predictors of fatigue are still not shown     up yet. Paper review indicated that the level of L-Carnitine concentration, which affect     metabolism of fatty acid, had correlation with fatigue and muscle strength in this     population. The serum concentration of L-Carnitine is influenced a lot by hemodialysis. When     there is deficiency of energy supply, it resulted to decline of muscle strength, which     increased frequency and intensity of fatigue. Hence, the purposes of this study are (1) to     understand the basic condition of fatigue level, muscle and metabolism of fat and     carbohydrate among hemodialysis patients, (2) to analyze correlation among muscle strength,     metabolism of fat/carbohydrate, and fatigue, and (3) to understand correlations among     demographic characteristics, blood test data (hemoglobin, albumin, Kt/V, urea reduction     ratio(URR), blood urea nitrogen(BUN), creatinine, calcium, phosphorus, and C-reactive     protein), mental and social conditions (depression, anxiety, and social support), muscle     strength and fatigue, seeking further exploring predictors of muscle strength and fatigue.      The study use cross-sectional descriptive correlative design with consecutive sampling.     Recruit patients from a hemodialysis unit in a medical center in north Taiwan after informed-     consent. The estimated sample size is 100. To understand relationship among muscle strength,     by-products of fatty acid and carbohydrate and fatigue, we collect data by measuring their     muscle strength (handgrip and 30 seconds sit-to-stand), and analyzing blood test data and the     structured questionnaires which included mental/social data (depression, anxiety, social     support and fatigue level). Descriptive statistics, ANOVA, Pearson's correlation, Spearsman's     rank correlation and stepwise regression were used to analyze the collected data. Hope this     research can get advance in comprehension of cause of fatigue and improve the fatigue symptom     of hemodialysis patients.   "
109955|NCT01846741|"     Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage     2) of the Model 106 VNS implantable pulse generator   "
109956|NCT01846728|"     Menopause is associated with weight gain, but the reasons why are not clear. In this study,     the investigators will determine if reducing estrogen levels causes a decrease in the ability     of the body to produce heat. If so, this would suggest this is one way that menopause may     cause weight gain.   "
109957|NCT01846715|"     The primary purpose of this study is to assess the safety and optimal delivery of the     Neo-Kidney Augment (NKA) when implanted at one site in a recipient kidney. NKA is made from     expanded autologous, homologous, selected renal cells (SRC) obtained from the patient's     kidney biopsy.   "
109958|NCT01846702|"     The main purpose of this study is to evaluate the safety and tolerability of the study drug     known as LY3084077 in healthy participants. The study will also investigate how much of the     study drug gets into the blood stream and how long it takes the body to get rid of it.     Information about any side effects that may occur will also be collected. The study is     expected to last approximately 8 weeks for each participant.   "
109959|NCT01846689|"     The objective of this study is to measure the change in blood values after the administration     of an amino acid based erythropoietin stimulating system.   "
111015|NCT01832870|"     This is a clinical trial designed to quantify the immune response and determine the     tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for     patients with advanced prostate cancer.   "
109960|NCT01846676|"     -  Introduction: Hearing loss is a prevalent condition in elderly population. However, the          low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In          2007 there was designed a rehabilitation program called ACE, which aims to improve          rehabilitation directed to hearing aids users. The study hypothesis is that a counseling          program will improve adherence to hearing aids in elderly population.        -  Objective: To evaluate the utility of a standardized counselling program in patients          with hearing loss.        -  Material and Methods: A before/after trial will be carried out, approved by the Hospital          ethics - committee. Patients with 65 years and older with hearing loss diagnosed by pure          tone audiometry will be included. To assess adherence we will use the IOI-HA scale.   "
109961|NCT01846663|"     The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with     severe hepatic impairment and Hepatic Encephalopathy.   "
109962|NCT01846650|"     1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg          (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets          (Manufactured by Roche Pharma AG)        2. Experimental Design： Two-period crossover design        3. Test drug: Capecitabine tablets Reference drug: XELODA        4. Sample size：24   "
109963|NCT01846637|"     The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first     one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away     from the pylorus.   "
109964|NCT01846624|"     This phase 2 study evaluates the sequential combination of decitabine then midostaurin for     the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.   "
109965|NCT01846611|"     The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a     third-line chemotherapy regimen (treatment) in patients with platinum-sensitive     advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who     received 2 previous lines of platinum-based chemotherapy.   "
109966|NCT01846598|"     Background and Purpose:The level of the surgical wound healing of the epidermis takes 6-12     hours, and the peak period of 48 hours to achieve healing.The traditional postoperative wound     care was every 1-3 days clean with saline and gauze or other dressing and not opened .In     traditional concept the wound touch the water that will increase the rate of wound     infection.England Department of Health in 2008 surgical wound care guidelines about surgery     wound cleaning solution comparison. It was no significant difference in wound infection.with     normalsaline and tap water. 2012 The Cochrane Collaboration: Water for wound cleansing     systematic review of the literature that wound clean water has no effect on the rate of wound     infection and healing rate, conducive to personal hygiene and cost-effective. Under high     temperature and humid environments in our country, after surgery not bathe often affect     patients' satisfaction and increase the cost of dressing and manpower, Was opened a line     after surgery the wound can be shower? It is important about surgical wound care guidelines,     but also the patient daily asked a high degree of issues. Purpose of this study (1)     post-operative 48 hours, shower or not wound infection rate (2) post-operative 48 hours,     shower or not the pain score (3) post-operative 48 hours, shower or not the comfortable (4)     post-operative 48 hours, shower or not the care costs.   "
109967|NCT01846585|"     The aim of the study is to improve sleep during pregnancy and the postpartum period in women     who are experiencing insomnia, using a brief non-pharmacological treatment.   "
109968|NCT01846572|"     The aim of this study was to determine the prevalence rate and risk factors for chemical     laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.   "
145296|NCT01382576|"     In the present study, serum chitotriosidase activity and its relationship with insulin     resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).   "
109969|NCT01846559|"     Platelets are the main type of blood cell involved in the formation of blood clots that cause     heart attacks. The investigators give antiplatelet drugs (aspirin, for example) to reduce the     risk of another clot forming in the future and causing another heart attack. Platelets are     known to have a role in inflammation and infection as well as clotting. In a recent large     clinical trial, known as the PLATO study, it was also shown that patients treated with a new     antiplatelet medication (ticagrelor) developed fewer lung infections, as well as fewer heart     attacks, compared to the current standard treatment (clopidogrel). The investigators would     therefore like to investigate the reasons behind this and look at the effect of these     medications on immune response. This may help us develop new drugs that have a better effect     on immune response. The investigators are planning a clinical trial that investigates the     effect of these medications on the immune response of healthy volunteers aged 18 to 65.      Only volunteers with no significant past medical history and not taking any medications will     be included.      Thirty volunteers will receive either a normal dose of ticagrelor or clopidogrel or no     antiplatelet medication for 1 week.      They will then attend the Sheffield Clinical Research Facility where their immune response     will be stimulated using a safe, well established method. The investigators will do this with     an injection of a low dose of endotoxin, which is part of the surface coating of some     bacteria and has been used extensively in similar studies, in over a thousand volunteers over     the past 20 years to investigate immune response. It is known to cause temporary flu-like     symptoms that last approximately 68 hours. The investigators will take measurements of     inflammatory markers, white blood cell function and platelet function and compare the effect     of ticagrelor and clopidogrel on this immune response.   "
109970|NCT01846546|"     Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and     modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous     angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the     secondary brain injury following TBI. The aim of this study was to investigate early changes     in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations     of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen     XVIII concentrations were measured serially for 1 week after hospitalization by using the     enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI     and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to     determine if its serial changes correlate with the GCS score and prognosis. Receiver     operating characteristic curve was used to appraise the value of CSF endostatin/collagen     XVIII levels in predicting the prognosis of patients with severe head injury.   "
110046|NCT01845558|"     The aim of the current study is to investigate the therapeutic effect and especially the mode     of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on     exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium     proficiency level compared to placebo.   "
110177|NCT01843855|"     The study is being undertaken to understand how a gastric bypass can affect a subject's     diabetes even prior to their losing significant amounts of weight. The hypothesis of this     study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration     in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.   "
109971|NCT01846533|"     Some possible humoural and cellular mechanism for diabetes related osteoporosis/fractures     were proposed and summarzied as the following, (1)Diabetes mellitus increases osteoclast     function but decreases osteoblast function, thereby leading to accelerated bone loss,     osteopenia and osteoporosis. (2)DM/hyperglycemia induces production of macrophage colony     stimulating factor (MCSF), tumor necrosis factor (TNF)-α and receptor activator of nuclear     factor-κB ligand (RANKL), all of which are osteoblast-derived activators of osteoclast     proliferation and differentiation. (3) DM/hyperglycemia suppresses osteoblast proliferation     and function, in part, by decreasing runtrelated transcription factor (Runx)-2, osteocalcin     and osteopontin expressions. (4)Adipogenic differentiation of mesenchymal stem cells is     increased as indicated by the overexpression of adipocyte differentiation markers, including     peroxisome proliferator-activated receptor (PPAR)-g, adipocyte fatty acid binding protein     (aP2), adipsin and resistin. A decrease in neovascularization may further aggravate bone     loss. (5)Bone quality is also reduced as a result of advanced glycation end products (AGE)     production, which may eventually result in low impact or fragility fractures. DM are     associated osteoporosis/fracture. The underlying mechanism, especially of type 2 DM, mandates     a DM-osteoporosis cohort to elucidate. In clinical practice, to developed preventive     strategies from osteoporotic-fracture is also necessary.   "
109972|NCT01846520|"     This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in     supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic     and lung cancers. Education and telephone counseling may reduce stress and improve the     well-being and quality of life of caregivers of cancer patients.   "
109973|NCT01846507|"     This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as     Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and     lead to an increase in the quality of life.      Menorrhagia in young women with bleeding disorders is typically treated with a combination of     treatments including hormonal contraceptives. However, there are barriers to hormonal     contraception use in younger adolescents.      Tranexamic acid is taken orally during the first 5 days of menstrual bleeding.      The purposes of this study include:      To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda     works in decreasing menstrual blood loss. To see if parents and children participating in     this study think the drug is improving their quality of life.      Lysteda has been approved by the Food and Drug Administration for use in patients > than 18     years of age but not for younger patients.   "
109974|NCT01846494|"     The purpose of this study is to monitor the cardiovascular and renal health of patients who     previously took BMS-986094 (an investigational medication for hepatitis C) in comparison to     hepatitis C infected patients who have never taken BMS-986094.   "
109975|NCT01846481|"     This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male     and female subjects with an American Psychiatric Association Diagnostic and Statistical     Manual DSM-IV-TR diagnosis of cocaine abuse.   "
109976|NCT01846468|"     The purpose of the study is to provide pertinent information to enable decisions regarding     the developability of LHW090 for use in patients with chronic renal insufficiency, including     a comparison of the potential risk-benefit ratio of several doses of the study drug to enable     optimal doses to be tested in later studies.   "
109977|NCT01846455|"     The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic     impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine,     norbuprenorphine, or naloxone.   "
109978|NCT01846442|"     The purpose of this study is to determine the dose-response of vaginal mucosa parameters to     the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from     vaginal atrophy.   "
109979|NCT01846429|"     The purpose of this study is to:        -  Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses          than those usually given for heartburn.        -  Determine if sodium bicarbonate can reduce cancer-related pain.   "
110024|NCT01845844|"     This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in     subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab     (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at     least 6 bevacizumab injections within 9 months of enrollment).   "
145297|NCT01382563|"     Develop Registry tool   "
109980|NCT01846416|"     This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab     (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC.     Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab     (MPDL3280A) on Day 1 of 21-day cycles until disease progression.      Eligible participants will be categorized in to three groups as follows:        1. Participants with no prior chemotherapy for advanced disease;        2. Participants who progress during or following a prior-platinum based chemotherapy          regimen for advanced disease (2L+participants);        3. Participants who are 2L+ and previously treated for brain metastases.   "
109981|NCT01846403|"     Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care,     we would like to document the feasibility and acceptability of a semi-quantitative pregnancy     test as an adjunct to or replacement of current monitoring protocols to offer women and     health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot     will help us to better understand how this tool complements existing monitoring protocols. If     a suitable addition, replacement to repeat blood draws for serum hCG assessment, the SQPT     could also contribute to efforts to make assisted fertility treatments more patient-friendly.     This study seeks to test this innovation by asking women assigned to perform a dBest®     semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis     for up to 4 weeks after embryo transfer.      We hypothesize that the test, which can be used at home by women, will provide confirmation     of the presence of a pregnancy compared with standard serum hCG testing because 1) it has     sensitivity and specificity that correlates well with serum testing, and 2) it can be used at     home and thus earlier to determine presence of hCG. Furthermore, a pregnancy can be assured     only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3     weeks after the next menses expected.      We hypothesize that women seeking assisted fertility treatments will be able to monitor their     hCG at home as well. Further, we plan to develop revised instructions to better suit the     needs and questions we think would be relevant to women desiring to use this test as part of     assisted fertility services.      We hypothesize that the simple instructions we will develop for use in this study will enable     women to use the test on their own. Provider counseling will complement these instructions     and contribute to overall quality of care given to each participant.   "
110178|NCT01843842|"     The purpose of this study is:        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper          respiratory tract infections in children;        -  to assess clinical efficiency of the liquid dosage form of Ergoferon for treatment acute          upper respiratory tract infections in children.   "
109983|NCT01846377|"     With the increasing rates of child obesity and diabetes, innovative programs are needed that     capture children's attention and permit behavior change messages to get through. Serious     video games with their immersive stories offer one such promising alternative due to their     low cost approach to intervention since the games have already been developed, and can be     broadly disseminated by simply reproducing and distributing their DVDs. While using video     games for health promotion is controversial, this study will establish whether video games     can effectively change diabetes and obesity risks (especially fasting insulin, diet and     physical activity) among children.      Escape from Diab and Nanoswarm: Invasion from Inner Space are two video games that     targeted children to increase fruit, vegetable and water intakes, reduce sedentary behaviors     (SB), and increase physical activity in a pilot study with a relatively low risk children. In     light of this, it is important to test whether these games can help decrease diabetes (i.e.     fasting insulin) and obesity risks with high risk (85%tile < BMI < 99%tile) 10 to 12 year old     children.      Children will be randomly assigned to treatment or control groups. The treatment group will     play Diab and Nano over a 3-month time period. A wait-list control group will receive the     Diab and Nano games at the end of their second post assessment (5-months post baseline     assessment).   "
109984|NCT01846364|"     Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such     as cabbage, cauliflower, broccoli, & Brussels sprouts) has been studied extensively in recent     years for its anti-cancer effects. DIM has been shown to exert control over cancer cell     growth in breast, uterine, cervical, ovarian, and colon cancer.      To date no human study has been published regarding the bioavailability of DIM in thyroid     tissue or its effects in proliferative thyroid disease. Our previous study attempted to     elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid     disease and ascertain its uptake in thyroid tissue. DIM has been shown to concentrate in the     thyroid gland. Furthermore, thyroid volumes have been seen to decrease subjectively.      This study would continue our attempt to elucidate DIM's promotion of anti-proliferative     estrogen metabolites in proliferative thyroid disease.   "
109985|NCT01846351|"     Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes     of intravitreal anti-VEGF therapy for eAMD.   "
109986|NCT01846338|"     The aim of this study is to investigate the therapeutic effects of green tea extract on acne     treatment and related hormone peptides by a double-blinded, randomized and controlled     clinical trial.   "
109987|NCT01846325|"     Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in     asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve     it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds     which are susceptible to oxidation and production of free oxygen radicals.   "
109988|NCT01846312|"     This study is conducted in the United States of America (USA). The aim of the study is to     assess longitudinal variation of immune biomarkers in subjects at risk for development of     type 1 diabetes (T1D).   "
109989|NCT01846299|"     To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult     patients with visual impairment due to macular edema (ME).   "
109990|NCT01846286|"     The goal of this research study is to learn more about chronic pain associated with cancer     treatment.   "
109991|NCT01846273|"     This study will compare the effect of ranibizumab administered as monotherapy versus     ranibizumab administered in combination with verteporfin PDT on visual acuity in patients     with symptomatic macular PCV. The results of this study will provide long-term safety and     efficacy data used to generate further guidance on the management of patients with PCV.   "
110063|NCT01845337|"     Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and     stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems     including heart attacks. An alternative drug, called teysuno is used extensively in other     countries instead of capecitabine and appears to have less of a bad effect on the heart     whilst still killing cancer cells. This study will investigate the effect of these two drugs     on the heart and blood vessels and will be the first of its kind in humans.   "
109992|NCT01846260|"     Cognitive impairment associated with chemotherapy is an important reported post-treatment     side-effect among breast and other cancer survivors. As some patients report cognitive     complaints before the administration of their therapy, some authors suggest an association     with psychological risk factors such as distress. Distress, a multifactorial unpleasant     emotional experience of a psychological (cognitive, behavioral and emotional), social and/or     spiritual nature that may interfere with the ability to cope with cancer effectively, its     physical symptoms and its treatment, can easily be assessed by the Distress Thermometer.      In this trial we aim to determine if the Distress Thermometer, accompanied by the 38-item     Problem List, could predict cancer-related cognitive impairment in patients with hematologic     malignancies, and in patients with gynecological, urological, breast, lung or     gastro-intestinal cancer receiving curative radiotherapy, chemotherapy, radiochemotherapy,     anti-hormonal or targeted therapy.   "
109993|NCT01846247|"     Phase 3, multicenter, international randomized controlled trial of a Very Early     Mobilization(VEM) care rehabilitation protocol compared to standard post stroke care (SC).     Participants receive either SC and VEM or SC alone in the acute phase of stroke up to a     period of 14 days.      Participants are followed up by a blinded assessor at 3 and 12 months post stroke to     determine trial outcomes.   "
109994|NCT01846234|"     Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the     differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were     described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis).      However, the role of sodium intake in MS has not been investigated. In this study we     investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological     activity.   "
110055|NCT01845441|"     Dexmedetomidine is a unique sedative medication able to provide sedation without causing     respiratory depression and maintaining neurological functions. Patients having an acute     ischemic stroke and need to undergo endovascular therapy require constant assessment of their     neurological status prior, during and after the interventional procedure. In this study the     investigators will compare the efficacy of Dexmedetomidine to other standard sedative     medications in providing optimal sedative effect while maintaining neurological function.   "
109995|NCT01846221|"     Epidural analgesia has proven to be an effective method for severe pain relief associated     with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and     narcotic will be administered through an epidural catheter. As labor progresses and the     baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs     further treatment. The investigators provide pain relief by administering analgesics through     the epidural catheter. The patients will be randomly assigned to receive one of two     medication mixtures believed to be successful in treating this type of pain associated with     advanced labor. After this initial treatment, if pain relief is not attained, the patient may     receive the other medication as well. The medications used in this study have been used at     this institution for some time and have been found to be safe for mother and baby. The opioid     (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other     medication (clonidine) better known as a blood pressure medication has also been used for     pain relief. Studies and clinical experience have shown that clonidine when given epidurally     in the doses used in this study has minimal, if any effect, on the blood pressure of the     mother or of the baby. The investigators will record medical and obstetric history and labor     progress relevant to the patient. The patient will be asked questions regarding labor pain     and side effects before and after the analgesic is administered. The primary objective is to     determine which treatment regimen is more successful in abolishing breakthrough pain in     advanced labor.   "
109996|NCT01846208|"     The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing     sustained unresponsiveness to egg exposure in children.   "
109997|NCT01846195|"     Non-invasive monitoring to measure changes in blood volume.   "
109998|NCT01846182|"     At least 1 in 4 of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer from     Gulf War Illness (GWI). Despite considerable research, effective treatments remain elusive.     GWI refers to a complex of symptoms that typically include widespread chronic pain,     persistent headache, memory and concentration problems, gastrointestinal difficulties, sleep     disturbances and unexplained fatigue. These symptoms are similar to that of fibromyalgia     syndrome (FMS), another multi-symptom condition. Whereas, effective treatments for GWI have     yet to be found, the FDA has approved duloxetine and pregabalin for the treatment of FMS. The     lack of progress in finding effective treatments for GWI, and the similarities between GWI     and FMS, provides a rationale for determining if these medications can provide relief to     Veterans who suffer from GWI. This randomized controlled trial will test the efficacy of     Duloxetine and Pregabalin for treating Gulf War Veterans who suffer from GWI.   "
109999|NCT01846169|"     This application, funded by the American Association of Retired Persons(AARP) Foundation, is     to implement the Healthy Eating for at Risk Older Adults (HERO) initiative. This initiative     will address barriers of affordability, and reduced mobility by providing older adults with     nutritious foods that are usually difficult to purchase due to high cost; delivering needed     foods to individuals in their homes; tailoring food delivery frequency based on level of food     insecurity; and offering basic nutrition education.   "
110000|NCT01846156|"     there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we     need to make a trial to find the best protocol   "
110001|NCT01846143|"     The purpose of this study is to learn what effects (good and bad) experimental phosphopeptide     vaccines plus a tetanus peptide and other substances called polyICLC and Montanide ISA-51     have on people with melanoma. The investigators will also look at whether the experimental     reagents cause any changes in the immune system.   "
110002|NCT01846130|"     The loss of muscle mass and function in older adults during bed rest is facilitated by     defects in the regulation of muscle protein metabolism, including an impaired ability to     mount an anabolic response to a mixed nutrient meal. The investigators propose that     low-intensity exercise and supplementing daily meals with leucine or whey will independently     and synergistically reduce the deleterious effects of inactivity on skeletal muscle and     facilitate recovery during rehabilitation. Metabolic measures will include: a) nutrient and     exercise-specific markers of translation initiation; b) skeletal muscle protein synthesis;     and c) a novel breath test of glucose tolerance. Morphologic and functional measures will     include: a) muscle mass and body composition; b) muscle strength and function; and c) motor     activation. The investigators will test the following hypotheses in older men and women     (65-80 years) during 7 days of bed rest followed by 7 days of inpatient rehabilitation:        1. Inactivity-induced metabolic dysregulation will blunt the anabolic response to meals,          facilitating a loss of lean muscle mass, glucose tolerance and functional capacity that          is partially restored during rehabilitation.        2. Supplementing daily meals with leucine or whey will maintain nutrient-stimulated          translation initiation and preserve the anabolic response to meal ingestion. This will          partially preserve lean muscle mass and function during bed rest and facilitate the          recovery of functional and metabolic capacity during rehabilitation.        3. Daily low-intensity exercise will preserve motor unit activation, stimulate the          exercise-regulated signaling pathway and normalize the anabolic response to meal          ingestion. This will partially preserve glucose tolerance, lean muscle mass and function          during bed rest and facilitate rehabilitation.        4. Leucine or whey-supplemented meals combined with low-intensity exercise will be a more          effective stimulus than either intervention alone, preserving glucose tolerance, lean          muscle mass and function during bed rest and facilitating a greater increase in          functional and metabolic capacity during rehabilitation.      This translational project will provide mechanistic and practical insight into strategies to     reduce the negative consequences of physical inactivity and promote rehabilitation in aging     muscle. Our novel, minimally invasive and clinically interventions have direct application     for older hospitalized patients at risk of accelerated muscle loss and diminished functional     capacity.   "
110003|NCT01846117|"     The investigators are investigating whether the flax lignan, secoisolariciresinol     diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to     be broken down in the body to produce the health benefits of flax. Flax lignan is separated     from the whole flax seed as this compound is believed to have health effects. Decreasing     oxidative stress and inflammation should improve a number of the problems associated with     aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an     equivalent amount of whey protein.      The investigators are comparing lignan to a placebo (whey powder) to examine whether a     dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and     inflammation.   "
110004|NCT01846104|"     The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg     booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg     doses of RVEc in a Phase 1 trial (NCT01317667).   "
110005|NCT01846091|"     This phase I trial studies the side effects and the best dose of viral therapy in treating     patients with squamous cell carcinoma of the head and neck that has returned (come back)     after a period of improvement or has spread to other parts of the body or breast cancer that     has spread to other parts of the body. A virus called encoding thyroidal sodium iodide     symporter, which has been changed in a certain way, may be able to kill tumor cells without     damaging normal cells.   "
110006|NCT01846078|"     Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.   "
111211|NCT01830283|"     To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after     the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination     was promoted by Beijing Center for Disease Control and Prevention in November, 2012.   "
110007|NCT01846065|"     Investigators have recently completed a pilot study exploring the safety and efficacy of     using a virtual-reality based cue platform to elicit craving in smokers with     schizophrenia(SWS)(Wehring et al, unpublished). In this study, participants with     schizophrenia (n=16) showed increased attention to cigarettes and changes in craving measures     when participating in the VR craving platform. In addition, participants tolerated the VR     environment without undue adverse effects or exacerbation of symptoms. Adverse effects from     the VR environment did not differ from that in a non-mentally ill population, and included     headache, nausea, and dizziness as most commonly occurring factors. Persons in this pilot     also showed acceptable rates of Immersion and Presence in the VR environment, showing the     potential use of this form of environment for this and other purposes.      In this study, investigators will examine virtual reality cue-reactivity in smokers with     schizophrenia, with a focus on the relationship of cue-reactivity with self-identified     triggers/cues. Smokers with schizophrenia often identify specific cues that trigger craving.     Many of these are environmental (scent, sight of smoking paraphernalia or cigarettes, related     objects, or social situations), however, a significant amount of smokers describe     emotionally-based factors (sadness, being upset, etc.) as primary cues and triggers. Most     methods used to elicit craving in experimental studies are executed via using environmental     cues like sight of cigarettes or smoking paraphernalia. It is not known if smokers with     schizophrenia(SWS) who are strongly emotionally triggered will be responsive to environmental     triggers in a cue-elicited craving platform. This is an important research question, as the     testing of anti-craving interventions should be generalizable for use across SWS with     differing triggers to smoking. The VR-based environmental program from our pilot study, which     includes sight, scent, and social cues, will be used to test pre-identified environmental     cues/triggers and their effects on cue-elicited craving in 30 SWS. Subjective reports, mood     and emotion measures, and objective physiological measurements will be used to identify and     quantify environmental craving responsivity as well as tonic craving.      Given the high prevalence of smoking among individuals with schizophrenia, understanding some     of the environmental factors that serve to maintain nicotine dependence is a critical step in     improving smoking cessation treatment outcomes. Establishing and validating a model of     cue-elicited responsivity will allow future investigations of craving, and ultimately designs     for studying the efficacy of anti-craving medications in people with schizophrenia.   "
110008|NCT01846052|"     The purpose of this study is to identify individuals with achromatopsia caused by mutations     in the CNGB3 gene and characterize their clinical condition using several tests of visual     function every 6 months for up to 1.5 years.   "
110009|NCT01846039|"     A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA®     to enhance the aesthetic appearance of the Asian nose.   "
110010|NCT01846026|"     Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with     bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased     permeability. Several cytokines are described to mediate the progressive course of ulcerative     colitis and it is considered nowadays an immunologic disease. Patients with UC have often low     levels of vitamin D and elevated prevalence of osteoporosis.      In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a     direct healing action on colonic mucosa has been described in animal studies. One can     therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with     UC. To our knowledge, it has not been performed randomized clinical trials to study these     possible effects of vitamin D and it has not been studied the effects of vitamin D on the     relapse frequency and immunological composition of colic mucosa in patient with moderate to     severe ulcerative colitis.      Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in     patients with moderate to severe ulcerative colitis:        -  reduces relapse frequency and increase the duration of the Infliximab induced remission        -  mediates and changes the cytokines composition in the colic mucosa        -  decreases the excretion of calprotectin in feces and reduces the concentration of          inflammation markers        -  augments bone mass   "
110011|NCT01846013|"     Purpose:      The purpose of this study is to implement and evaluate a randomized controlled trial in     sitting office workers to reduce sitting time through the use of motorized and non-motorized     sit/stand workstations as well as a walking intervention.      Hypotheses:        1. Compared to the control group, total physical activity will be higher in the standing          and walking intervention groups.        2. The combined standing and walking group will have higher total physical activity than          the other three groups.        3. Compared to the control group, the fitness and health outcomes will be improved for the          standing and walking groups.   "
110012|NCT01846000|"     The purpose of this study is to assess the effect of low-level laser on pain, occlusal     contacts, mandibular movements and electromyography activity in the masseter and temporal     muscles in adolescents with TMD.   "
110013|NCT01845987|"     The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959     following subcutaneous administration in participants with palmoplantar pustulosis.   "
110064|NCT01845324|"     The investigators asume that the measurement of the fetal heart interventricular septum can     serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus.     The investigators will measure the septum width in patients with Diabetes and will correlate     to standard measurements of the glucuse levels.   "
110065|NCT01845311|"     The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2     Bioresorbable Coronary Scaffold in native coronary arteries.   "
110868|NCT01834781|"     The purpose of this study is to determine whether pulsed electromagnetic fields(PEMF) is     effective in the treatment of multiple chemical sensitivity in terms of life impact,     symptoms, psychological distress, markers of central sensitization and the immune system, and     quality of life.   "
110014|NCT01845974|"     This study is examining data elements of hemodynamic, electrophysiologic and electrolyte     trends comparing 2 different types of catheters used during a procedure to treat medication     resistant atrial fibrillation- an irregular heart beat- called radiofrequency catheter     ablation. A high flow catheter delivers a higher volume of saline during the procedure. The     low flow catheter delivers a lower volume of saline during the procedure. The patient will be     consented and randomized to one of the 2 groups using a computer generated randomization     chart. Those that are put in the low flow catheter group will be considered the experimental     group. All data will be collected before and after the procedure and each patient will act as     their own control within each group. The hypothesis is that using a lower flow catheter will     cause less hemodynamic, electrolyte, and electrophysiologic derangements resulting in better     patient outcomes and fewer complications   "
110015|NCT01845961|"     The objective of this proof-of-concept pilot study to evaluate galantaminehydrobromide     extended-release (ER) as a potential smoking cessation aid in treatment-seeking smokers.   "
110187|NCT01843725|"     Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to     assess the safety and tolerability of capecitabine given in combination with aflibercept in     patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in     terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To     establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with     Aflibercept.   "
110018|NCT01845922|"     The study is based on a master thesis which showed that 72% of patients with head and neck     cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding     syndrome after admission.      Refeeding syndrome is characterized by a decrease in plasma phosphate levels, which develops     after the reintroduction of an adequate food intake after a longer period of starvation or     semi-starvation. This normally happens within 7 days after reintroduction of food.      The aim of this study is to minimize the incidence of refeeding syndrome in this group of     patients by reintroducing food slowly and by providing a diet low in sodium and high in     slowly absorbed carbohydrates as a prevention diet (i.e. given before a potential decrease in     plasma phosphate levels appear). Both patients that eat normally, patients with eating tubes     and patients with central vein catheters are included in the study, but the data will be     evaluated both together and separately.   "
110019|NCT01845909|"     The investigators have created a way of quickly collecting information in a large scale young     population regarding the presence of some severity indicators that may allow us to classify     them into: seemingly low risk and possible elevated risk for the presence of heart     disease. It would have to be a short questionnaire, in order to receive a great adherence but     that could simultaneously provide precise information, with an adequate description of     symptoms and warning signs, in a way that a triage in the young adult population could be     performed in the general young adult population in order to select individuals with an     indication for personalized clinical evaluation and possible need of complementary diagnostic     means. Based on this premise the investigators have developed a fast-response questionnaire     named the Sudden Cardiac Death Screening Of risk factorS (SCD-SOS). This questionnaire has     already been tested in a population of approximately 1500 young adults, and some changes have     been introduced in order to refine its performance.      To best of the investigators knowledge, there are no large scale European surveys estimating     the prevalence of cardiac disease and associated clinical symptoms in a non-selected     (non-athlete) population of this age group.      Purpose: To screen a young adult population from central regional of Portugal for heart     disease possibly associated to a high risk of Sudden Cardiac Death (SCD).      To determine the national prevalence of clinical symptoms of heart disease and of heart     disease with increased risk for SCD in this age group.      To detect young adults in risk of SCD and with an indication for evaluation by a     cardiologist, and possible need of:        -  medical treatment        -  electrophysiologic (EP) study and percutaneous ablation        -  an implantable cardiovertor defibrillator        -  a pacemaker        -  other type of specialized cardiac intervention   "
110020|NCT01845896|"     The purpose of this study is to investigate the effects of a combined training programme and     a high intensity interval training programme on insulin resistance, muscle strength/ muscle     contractile properties, aerobic capacity and body composition in MS patients.      It is assumed that the the above mentioned clinical parameters will improve due to physical     exercise.   "
110021|NCT01845883|"     In this proposal the investigators have three Specific Aims using human patient populations     as model systems; 1) identify a role for the Basal Ganglia (BG) in perceptual decision     making; 2) determine whether the Basal Ganglia contribute to decision making under conditions     of visual uncertainty; 3) determine whether the cerebellum plays a role in perceptual     decision-making under conditions of visual uncertainty. The investigators designed     experiments using healthy humans and humans with diseases known to affect the Basal Ganglia     and the cerebellum, Parkinson's Disease, dystonia and non-dystonic cerebellar damage. With     this approach the investigators will test the following hypotheses: 1) Patients with     Parkinson's Disease and dystonia will have more difficulty than healthy controls making     perceptual decisions when faced with sensory uncertainty; when sensory information is     certain, patients will show improved decision-making but will still be impaired relative to     healthy humans. Hypothesis 2: If ambiguous sensory information is aided by prior information,     patients with Parkinson's Disease and dystonia will be unable to use the prior (bias/memory)     information to inform their decisions. Hypothesis 3: Deep Brain Stimulation (DBS) of Basal     Ganglia structures will improve the ability of patients to use prior information to inform     their decisions when faced with sensory uncertainty. Hypothesis 4: Both cholinergic and     dopaminergic medical therapies will improve the ability of patients to use prior information     to inform their decisions. Hypothesis 5: Patients with non-dystonic cerebellar damage will be     similar to healthy controls in performance of a perceptual decision making task in conditions     of visual uncertainty. The overarching framework of this application is that the same     mechanisms (D1 striatal synaptic plasticity) that operate in reward learning play a role in     learning and using stimulus priors in a perceptual decision-making task when faced with     uncertainty. Because Parkinson's Disease and dystonia share deficits in striatal circuitry,     the patient deficits on this task will be similar. Because non-dystonic cerebellar patients     do not have dysfunction of striatal circuits, they will show no deficits in the ability to     use stimulus priors to guide choices in uncertain conditions. In the event these patients do     show deficits, this is will provide evidence for an unexplored role for the cerebellum in     perceptual decision-making.   "
110022|NCT01845870|"     Diabetic nephropathy(DN)is a major microvascular complication of diabetes.Renal injury may be     presented with the characteristics of albuminuria, and its main pathological change is     glomerular sclerosis. However, both glomerular lesions such as glomerulosclerosis, glomerular     basement membrane thickness and tubulointerstitial fibrosis have been found in both type 1     and type 2 diabetic patients with normal urinary albumin excretion rate, moreover the tubular     injury may be the primary pathological change in diabetic renal injury not only the secondary     change brought on by glomerular injury. Thus, if overt urinary albumin exists in T2DM     patients, the tubular injury may be severe already. An index which is predominant, sensitive     and convenient to be measured should be purposed.It is predicted that insufficient renal     1-alpha hydroxylase may play a critical role in diabetic nephropathy. Then the investigators     present the presumption that the activity of renal 1-alpha hydroxylase could reflect the     degrees of tubulointerstitial injury, using serum 1,25-dihydroxyvitamin D level as an index.   "
110025|NCT01845831|"     High blood glucose levels in hospitalized patients with diabetes are associated with     increased risk of medical complications and death. Improved glucose control with insulin     injections may improve clinical outcome and prevent some of the hospital complications.     Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the     hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot     study aiming to determine differences in glycemic control between treatment with sitagliptin     (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general     medicine and surgery patients with type 2 diabetes (T2D). The investigators found that     treatment with sitagliptin alone or in combination with basal insulin resulted in similar     glycemic control compared to basal bolus regimen.      The investigators will conduct a prospective RCT aimed to determine the safety and efficacy     of sitagliptin therapy for in-hospital and post-discharge management of general medicine and     surgical patients with T2D. A total of 280 patients with known history of diabetes will be     randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or     basal bolus regimen with glargine once daily and aspart or lispro insulin before meals (group     2). If needed, patients in the treatment groups will receive correction doses of rapid-acting     insulin in the presence of hyperglycemia (BG > 140 mg/dl). The overall hypothesis is that     treatment with sitagliptin in combination with basal insulin in patients with type 2 diabetes     will result in a similar improvement in hospital and post-discharge glycemic control and in a     lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with     glargine once daily and lispro insulin before meals.      Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University     of Michigan, Ohio State University and Temple University   "
110026|NCT01845818|"     This observational study will document to what extend in daily clinical practice the work     productivity is affected before and after the start of adalimumab treatment.      Changes in the employment status and work productivity of patients with AS and PsA before and     after the start of Adalimumab will be noted. The relationship between employment status, work     productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA     might be very invalidating diseases with a strong impact on the daily life of the patient, an     evaluation will be performed to the effect of the disease on Quality of Life and work     productivity.   "
110027|NCT01845805|"     To improve progression free survival in high risk patients with resected pancreatic     adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in     CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of     adjuvant therapy.   "
116113|NCT01766037|"     This research study is being performed to find out if a new device, AspireAssist Aspiration     Therapy System, can help people with obesity to lose weight without causing too many side     effects.   "
110029|NCT01845779|"     Complete response is a rare event in metastatic anal cancer in the case of unresectable     recurrence after radiochemotherapy.      In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were     treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel,     Cisplatin and 5-Fluorouracil.      In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection,     that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was     identified within the tumor samples.      The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with     DCF and contributed to the elimination of the tumour cells and to the increase of complete     responses. The aim to this study is to analyze immune response against HPV in this patients     in complete response.   "
110030|NCT01845766|"     We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic     shock would decrease their functional disability and cognitive impairment. We plan to enroll     patients with severe sepsis and septic shock who admitted an urban teaching hospital in     Seoul, South Korea via ER. We will randomize those subjects into the intervention group which     will take a standardized rehabilitation with routine clinical care for sepsis and the control     group which will take routine clinical care for sepsis. And, we plan to assess their     functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time     of enrollment, 28 days, and 6 months later.   "
110031|NCT01845753|"     A clinically applicably strategy for molecular screening for Lynch Syndrome is being     implemented in Denmark.      Based on sequential analysis with immunohistochemistry and methylation analysis, patients     with possible hereditary colorectal cancer are identified. These patients are offered genetic     risk assessment and counselling.      The study hypothesis is that molecular screening will identify more patients with Lynch     Syndrome than the family history alone.      Prospective data collection is performed using established clinical databases.   "
110032|NCT01845740|"     Milatuzumab will be given subcutaneously at different dose levels once (depending on the dose     level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).   "
110033|NCT01845727|"     The proposed study encompasses a two-step approach. The first aiming to determine the safety     of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in     subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in     having and indication of the efficacy of the two above mentioned regimens of Topical 3%     Amphotericin B Cream      For the first step, 30 subjects will be randomly assigned to receive direct observed     treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per     day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each     group) have been enrolled and completed the 28 day treatment course. An interim analysis of     all safety (Adverse Events, including local reactions and lab parameters) and     pharmacokinetics collected on subjects who were randomized will be performed by data safety     monitoring board. If no serious adverse events (SAEs) related to the study drug are     identified on the first 30 subjects by the end of the treatment course, 50 additional     subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three     or two times per day for 28 days      Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5 days     and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as     measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization of     the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to Day     180 for final analysis of efficacy.   "
110034|NCT01845714|"     Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on     vision-specific quality of life. This study attempts to confirm this statement and assess     whether cross-linking and cross-linking combined with photorefractive keratectomy improve     vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.   "
110105|NCT01844791|"     The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS     in combination with Platinum-Gemcitabine based doublet first line therapy in stage IV     non-small cell lung cancer (NSCLC) patients.   "
110879|NCT01834638|"     This is a study of ABT-126 in the treatment of cognitive impairment associated with     schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).   "
110035|NCT01845701|"     To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in     comparison with artemether-lumefantrine during 42 days follow up period in 720 children with     acute uncomplicated P. falciparum malaria, in two different endemic ecological areas -     Savanna and equatorial forest regions of Cameroon.      We have set as specific objectives:        -  To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in          comparison with artemether-lumefantrine during 14 and 28 days follow up period in          children with acute uncomplicated P. falciparum malaria in two different endemic areas.        -  To evaluate the safety of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in          comparison with artemether-lumefantrine during 42 days follow up period in children with          acute uncomplicated P. falciparum malaria.        -  To determine parasite clearance time (PCT) and fever clearance time (FCT) following the          administration of the three trial regimens.        -  To investigate the treatment response based on WHO criteria (WHO, 2003) in patients in          all groups after trial.        -  To investigate the Single Nucleotide Polymorphisms (SNPs) and microsatellite markers of          genes associated with drug resistance   "
110036|NCT01845688|"     The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen     Granule to treat idiopathic membranous nephropathy.   "
110037|NCT01845675|"     Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in     well-differentiated pancreatic neuroendocrine tumor   "
110056|NCT01845428|"     The purpose of this research study is to learn if using statin in patients with nephrotic     syndrome could lower the risk of blood clots. Nephrotic syndrome is a collection of signs and     symptoms that occur when the glomeruli -the tiny filters that work in the kidney- leak     protein in the urine.      One of the symptoms associated with nephrotic syndrome is hyperlipidemia: too much bad     cholesterol (LDL). This bad cholesterol could be linked to the increased risk of blood clots     in patients with nephrotic syndrome. The study doctors would like to see if taking a statin     drug to reduce the amount of bad cholesterol could reduce the risk of blood clots.   "
110038|NCT01845662|"     Purpose: Non-traumatic rupture of the spleen should be suspected when patients (especially     young men) present with abdominal pain and a history of acute infectious or     myeloproliferative disorders. Preoperative imaging studies in hemodynamically stable patients     may obviate the need for surgery even in the presence of massive hemoperitoneum. The purpose     of this research is to inform acute management where spontaneous rupture is suspected in     order to avoid surgery where appropriate, rationalise angiographic intervention and blood     transfusion.      Hypothesis: Indentifying the cause of injuries can help target preventative intervention.      Background: Non-traumatic rupture of the spleen is a rare condition. It may occur in the     diseased spleen secondary to a variety of pathologies including malaria and     myeloproliferative disorders. In some cases rupture may occur in an apparently normal spleen.     The incidence, symptoms, causes, therapy and prognosis are poorly defined. The investigators,     therefore, propose an extension of retrospective analysis conducted, presented and published     in 2003 to examine all the cases of non-traumatic splenic rupture treated at Ziv Medical     Centre from the last 26 years to present.      Methods: Analysis of the medical notes of all patients with spontaneous splenic rupture in     the medical archives.      The investigators hope to determine the true incidence of this condition within the local     population, increasingly diverse in origin, travel and the incidence of predisposing     infectious disease; and to devise a practical protocol in their safe diagnosis and     management, especially as non-operative interventions have grown in safety and effectiveness.      Discussion: Although rare, spontaneous splenic rupture may be fatal if not suspected or     treated inappropriately. Understanding the pitfalls in diagnosis and management better     informs decision making towards improved care of these patients.   "
110039|NCT01845649|"     The purpose of the study is to determine if WC3011 is safe and effective in treating the     symptom of painful intercourse secondary to vulvovaginal atrophy as measured by subject     self-assessment when compared to vehicle.   "
110040|NCT01845636|"     Odor identification deficits, which are a result of early Alzheimer's Disease (AD) pathology     in the olfactory bulb and tract as well as olfactory projection areas in the medial temporal     lobe (entorhinal and piriform cortex and hippocampus), lateral and central orbitofrontal     cortex and several other regions, occur in AD and strongly predict mild cognitive impairment     (MCI) conversion to AD. Our pilot data, along with converging findings in the literature,     suggests that odor identification deficits, both incremental change over time and change in     response to an anticholinergic challenge, may be clinically simple, relatively inexpensive,     predictors of cognitive improvement with acetylcholinesterase inhibitor (ACheI) treatment     with potential clinical implications for predicting improvement and monitoring ACheI therapy.   "
110041|NCT01845623|"     This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of     indacaterol maleate (QAB149), administered via the EPIC test fixture. The study aims to     determine whether the novel device has a similar clinical profile as the established concept     1 device.   "
110042|NCT01845610|"     Complementary food supplements (CFS), fortified products that are mixed with the infant's     usual complementary foods, have the potential to improve nutrition among infants. In Africa,     maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize     has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit     their absorption. The impact of CFS products in the context of a maize-based diet has not     been well investigated. This study will test two newly developed fat-based CFS products made     from soy.      The first product is a fortified fat-based spread that contains essential fatty acids with     added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and     zinc bioavailability. The second product is a fortified fat-based product containing     essential fatty acids. Both products contain soy. The enrichment of the products with     essential fatty acids is of particular interest in the South African context, as consumers     are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high     LA-containing sunflower oil during food preparation. The CFS products could contribute     towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.      The results of this study will provide evidence on whether or not two types of fortified CFS     have the potential to address malnutrition (linear growth) and improve psychomotor     development in infants. If proven effective, this approach of providing multiple nutrients     can be made available to infants in the developing world and may lead to sustainable actions.   "
110043|NCT01845597|"     The purpose of this study is to determine the survivorship rate of robotic assisted medial     partial knee replacement at a two, five, and ten years.   "
110044|NCT01845584|"     Patients diagnosed with anti-aquaporin 4 antibody positive Neuromyelitis Optica spectrum     disorder were confirmed based on diagnostic criteria. Patients who meet all inclusion     criteria and do not conflict with the exclusion criteria will receive steroid plus therapy     （1g/day for five consecutive days）. Subsequently, patients who not provided adequate effect     of therapy to steroids plus therapy will receive NPB-01 (intravenous immunoglobulin)     400mg/kg/day for five consecutive days. Patients evaluated Quantification of nerve and spinal     cord impairment （QOSI） and the Expanded Disability Status Scale （EDSS）/ Functional Systems     （FS） and anti-aquaporin 4 antibody et al.      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse     events by one year after the start of the study treatment.   "
110930|NCT01833975|"     This Study is a single arm,Phase I/II , single centre trial to check active comparing the     safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be     conducted for 36 months.   "
110045|NCT01845571|"     Background:      Rhegmatogenous retinal detachment is an ophthalmic emergency that, without surgical repair,     often leads to blindness. The incidence is about 1/10000/year. The leading causes are myopia     and aging which cause retinal tears often resulting in retinal detachment. Patients commonly     experience photopsia, floaters, and peripheral visual field loss.      Two different general surgical treatment options exist for retinal detachment; scleral     buckling or vitrectomy. However, the precise indications for each approach have not been well     established. Correct classification of the retinal detachment is important. The first step is     to decide whether an intra- or extra-ocular surgical approach is more appropriate. Simple     rhegmatogenous retinal detachments are usually treated extraocularly with scleral buckling     surgery, whereas more complicated cases require intraocular primary pars plana vitrectomy and     one or more of gas, silicone oil, laser therapy, or cryotherapy.      Study objectives:      The purpose of this study is to evaluate different surgical techniques for the treatment of     retinal detachment. Data relating to retinal status before treatment, surgical treatment,     post-operative anatomy and visual acuity, post-operative OCT, and intra- and post-operative     complications will be collected.      Vitreous cytokines will also be analyzed to monitor intravitreal inflammation as a result of     retinal detachment.   "
114100|NCT01792401|"     The purpose of this study is to investigate the effect of probiotics in enteral nutrition on     improving gut function, inflammatory markers and clinical outcomes in critically ill patients     admitted to the intensive care unit.   "
110047|NCT01845545|"     Investigators propose a feasibility and pilot study for a cluster randomised controlled     trial. The proposed trial will evaluate the effects of an economic intervention     (microfinance) in self-help groups of poor and marginalised women in three provinces in     northern India, upon the health of these communities, with a focus on children under five     years. This feasibility and pilot study will determine whether accurate data can be collected     on mortality by means of a house to house survey or from the register of births and deaths.     The feasibility stage will also determine whether village volunteers can accurately weigh     children under five and record their weights alongside the financial data already recorded by     the self-help group. If these data are accurate and can be collected reliably, the     investigators will calculate the power and sample size needed for a future cluster randomised     trial, as well as analysing preliminary results from the current project. The investigators     will evaluate health outcomes, relating to two Millennium Development Goals: number of     children under five years of age who are underweight and the under five mortality rate.   "
110048|NCT01845532|"     Laparoscopic operative procedures have revolutionized gynecological surgery. These have     several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter     postoperative stay, which cuts down on hospital costs. However, postoperative pain continues     to be one complication, which results in an unpleasant experience for the patient and at     times causes a delayed discharge. Trigger point injection removes the pain developing point     and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin.     An literature showed that patch of local anesthetics showed the effect of trigger point     inject. The purpose of this study is to investigate the alleviation of shoulder pain,     headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying     on shoulder in patients undergoing total laparoscopic hysterectomy.   "
110049|NCT01845519|"     This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm     randomized walking intervention. All intervention materials will be delivered electronically.      The investigators hypothesize that at the end of 12-weeks, participants randomized to the     intervention group will engage in more weekly steps than those participants randomized to the     comparison group.   "
110050|NCT01845506|"     The primary outcome for this project will be the development of a small, non-invasive     wireless sensor that is linked to a conventional computer that can be used in health care for     monitoring of acute and chronic health problems. The advantages of developing this technology     are threefold. First, monitoring can be conducted for a fraction of the cost of a bedside     nurse. Second, monitoring can be done in real time and stored so that we can diagnose and     manage critical events in a more timely manner. Lastly, many patients can be monitored     simultaneously. The wireless sensors will be fitted to healthy volunteers of various ages.     The data gathered from the sensor with respect to their vital signs will be compared to that     of conventional tools such as nursing assessments and pulse oximetry.   "
110051|NCT01845493|"     The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN)     for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is     possible with this supplementation regimen in individuals with allergic asthma.   "
110052|NCT01845480|"     Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and     word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants     will be randomly assigned to either healthful eating and physical activity skills coaching or     general health education coaching intervention conditions. For both conditions, research     assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of     each participating child.      Assessments will be completed at baseline, intervention end (3 months), and follow-up (6     months), comprising biomedical and psychosocial measures. Biomedical measurements to be     obtained include:        -  body composition (DEXA, tetrapolar bioimpedance, body mass index, waist circumference)        -  blood pressure (automated sphygmomanometer),        -  pulmonary function tests (forced expiratory flow in 1-sec, forced vital capacity, forced          expiratory flow at 25-75% of vital capacity),        -  unstimulated whole (mixed) saliva passive drool to detect markers of inflammation,        -  and physical activity levels (7-day accelerometry).      Psychosocial measurements include:        -  fruit and vegetable consumption (Child Dietary Questionnaire)        -  self efficacy,        -  enjoyment        -  quality of life (Peds QL).      Inclusion criteria are:        -  being female        -  aged 8-13 years        -  with parental consent,        -  residing within a 40-minute drive        -  being available for 12 home coaching visits and three lab assessments.      Exclusion criteria are        -  having developmental delay or psychiatric problems,        -  any illness, injury, condition, or disease that would prevent participation in          moderate-to-vigorous physical activity,        -  taking weight-altering medications        -  participating in any other health behavior change program.      The objectives of this study are to determine        -  whether both types of the home-based coaching interventions are feasible        -  whether the healthful eating and physical activity skills coaching intervention is more          efficacious, relative to the general health education coaching group, in preventing          increases in body fat percentage, body mass index percentile, waist circumference,          systolic and diastolic blood pressure, and sedentary behavior        -  whether the healthful eating and physical activity skills coaching intervention is more          efficacious, relative to the general health education coaching group, in facilitating          increases in quality of life, moderate-to-vigorous physical activity, enjoyment of          physical activity and fruit and vegetable consumption, and self-efficacy for physical          activity and fruit and vegetable consumption.      We hypothesize that the research project will be successful in recruiting and retaining     participating families, training research assistants to deliver the intervention components,     and that both of the coaching conditions will be well received and appreciated by     participating families. We hypothesize that the healthful eating and physical activity skills     coaching intervention will be more effective than the support coaching condition in     preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both     intervention conditions will show improvements to pediatric quality of life measures, but     that the healthful eating and physical activity skills coaching intervention will be more     effective than general health education coaching condition in increasing physical activity,     physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and     vegetable enjoyment and self-efficacy.   "
110053|NCT01845467|"     BACKGROUND:      Auto immune pancreatitis (AIP), a benign pancreatic disease has certain morphological forms     which mimics pancreatic malignancy in radiological appearance. There is no singe diagnostic     test which can accurately differentiate these two conditions. In the past, AIP accounted for     up to 27% of Whipple resections performed for suspected adenocarcinoma.      AIMS:      To evaluate the efficacy of Secretin assisted Magnetic resonance cholangio pancreatography     (MRCP) in differentiating AIP and pancreatic malignancy.      METHODS:      100 patients suspected with AIP will be consented to participate in the study to undergo     secretin MRCP in addition to their other standard investigations. Patients will be     categorized as those with AIP and with pancreatic malignancy based on these results and will     be followed. Follow up will eventually give the true diagnosis when patients with pancreatic     malignancy undergo pancreatic surgery and their pancreatic tissue is examined by     histopathologist. AIP patients will undergo steroid trial which will give the true diagnosis.     The preliminary diagnosis results based on standard investigations with and without inclusion     of secretin MRCP will be compared to the true diagnosis.   "
110054|NCT01845454|"     The primary objective of this study is to determine the percentage segment regression after     spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's     Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended     therapeutic range.      Secondary objectives are the determination of safety related outcomes such as esophageal     stricture.   "
111765|NCT01823016|"     The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics     (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with     persistent asthma that is inadequately controlled despite current treatment.   "
110057|NCT01845415|"     Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the     developed and implementation of a social marketing intervention campaign aimed at lowering     the incidence of falls to children in the home; City of Hamilton - Public Health Services     (Control), Durham Public Health, Haldimand-Norfolk Health Unit, Niagara Region Public Health,     Wellington-Dufferin-Guelph Public Health and Windsor Public Health (Control). This campaign     is based on community-based intervention research and 'best practices' for improving parent     attitudes and behaviours toward child safety. The campaign will focus on increasing parents'     awareness and knowledge of fall injuries, positively impact parental attitudes to motivate     them to want to implement strategies to reduce fall risks, and increase parental safety     practices that would counteract the most common mechanisms that contribute to home falls for     children at these young ages. The campaign will run from September 2013 through August 2014.     The PHUs' social marketing campaign will strategically disseminate different materials to     their respective communities: printed materials (posters, pamphlets), video modules about     parenting safety, safety information through an e-Health website, and direction communication     with parents through Family Health Team practitioners.      The proposed research project will request archival data from Canadian Institute of Health     Information (CIHI), specifically from their National Ambulatory Care Reporting System     (NACRS), on frequency of falls in the home to determine the extent to which the social     marketing campaign is effective. Comparing pre-, during and post-intervention levels in the     PHU communities will determine if and which social marketing strategies were effective.     Additionally, random digit dialing will be used to assess pre vs post parental fall related     attitudes, behaviors and intervention exposure. This evaluation will provide the first ever     test of a community level intervention to reduce childhood falls in the home in Canada and     will provide valuable information about what constitutes 'best practices' for preventing     falls in the home among children 1 through 4 years of age.   "
110058|NCT01845402|"     The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is     not known, but there is evidence of CKD in young adults. In the present study assumption is     made that CKD can already by diagnosed in patients at or just before adolescence, and the aim     is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which     will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring     peri-operatively during initial surgery or during follow-up could by chart review and     regression analysis.   "
110059|NCT01845389|"     Geriatric patients have a significantly higher incidence of morbidity and morality during     surgery compared with younger age group. Transurethral resection of the prostate (TURP) is     the gold standard treatment for elderly patients with bladder outlet obstruction. Thus     Regional techniques may be better tolerated in the elderly patients undergoing TURP having     the advantages of minimizing blood loss and thromboembolic events. The Wiley Spinal™ (Epimed;     Johnstown, NY) catheter is an innovative flexible cannula over needle designed for convenient     intrathecal access that reduces PDPH. We hypothesized that using less anesthetics during     continuous spinal anesthesia with the Wiley spinal catheter would offer more hemodynamic     stability with less side effects when compared with continuous epidural anesthesia in     patients undergoing TURP   "
110060|NCT01845376|"     This present randomized trial is designed to evaluate the postoperative pain,inflammatory     marker, postoperative analgesic medication, length of hospital stay and the modifications of     inflammatory mediators in patients undergoing inguinal hernia repair using local, spinal or     general anesthesia.   "
110061|NCT01845363|"     Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented     with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at     the beginning and end of surgery, were analyzed using high performance liquid chromatography.      Some published studies suggest that the dose of 2g does not supply the minimum inhibitory     concentration for principal causal agents of surgical site infection.      To determine the concentration of Cefazolin in adipose tissue of patients undergoing     bariatric surgery and to evaluate the relationship between concentrations obtained and body     mass index (BMI).   "
110062|NCT01845350|"     The purpose of this study is to determine whether M2 macrophages are safe and feasible in the     treatment of non-acute stroke patients   "
110646|NCT01837732|"     The aim is to investigate the feasibility and efficacy of a relational touch / relational     intervention on persistent pain in a long term geriatric hospital care ward population. The     main issue is the pain reduction. The hypothesis is that this type of intervention is very     useful on pain reduction in old people even with physical or mental disability.   "
110066|NCT01845298|"     The investigators' objective is to describe the variability of rifampicin absorption, markers     of inflammation and gut damage, intestinal absorptive capacity, and intestinal permeability     among HIV-infected volunteers. Rifampicin is the least well absorbed of the first-line     anti-tuberculosis drugs. Rifampicin malabsorption is frequently observed in HIV-infected     patients with active tuberculosis, but cannot be predicted by patient factors such as CD4+ T     cell count, viral load, or the presence of diarrhea. The mechanisms for rifampicin     malabsorption in HIV-infected patients are unknown. An understanding of mechanisms for     rifampicin malabsorption could eventually lead to new therapeutic targets, with the ultimate     goal of improving HIV/tuberculosis treatment outcomes.   "
110067|NCT01845285|"     The purpose of this postmarket Registry is to assess the standard of care and clinical     outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical     routine according to the approved commercial indications. Procedures and assessments required     by this registry are generally considered standard of care for Transcatheter Aortic Valve     Replacement patients.      Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical     performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and angiographic     imaging.   "
110068|NCT01845272|"     This study is designated to evaluate the pharmacokinetic interactions of candesartan     cilexetil and amlodipine besylate in healthy male volunteers.   "
110069|NCT01845259|"     Metabolic disturbances, obesity and life-shortening cardiovascular morbidity are major     clinical problems among antipsychotic-treated patients. Especially two of the most     efficacious antipsychotics, clozapine and olanzapine, cause weight gain and metabolic     disturbances and can rarely be replaced by other drugs due to the effectiveness of the     compounds. Glucagon-like peptide 1 (GLP-1) has improved glycemic control among patients with     type 2 diabetes. The study will investigate whether the beneficial effects of GLP-1 analogues     on glycemic control in type 2 diabetic patients, can be extended to a population of     non-diabetic, dysglycemic psychiatric patients, receiving antipsychotic medical treatment.   "
110080|NCT01845116|"     The purpose of this study is to determine whether the omega-3 fatty acid emulsion     (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is     effective in treating parenteral nutrition associated liver disease (PNALD) in children.      The study hypothesis is that Omegaven® can be safely provided to children who are dependent     on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until     the child can take adequate nutrition by mouth.   "
110070|NCT01845246|"     Objectives: Main objective: to assess the impact of an intervention for optimizing the dosing     of colistin based on its plasma levels in patients with infections due to multi-drug     resistant gram negative bacilli. The impact will be evaluated in terms of clinical and     microbiological outcome, and toxicity.      Secondary objectives:        1. To determine the percentage of patients reaching plasma levels considered adequate (Cmax          / MIC 8-10) for the treatment of infections due to gram-negative bacilli susceptible to          colistin, in the cohort of patients treated with standard doses of this drug without          adjusting the dose.        2. To analyze the possible emergence of bacterial resistance to this drug and its          relationship to the calculated colistin pharmacokinetic and pharmacodynamic indexes.      Methods:      Design: open controlled trial, blinded for the analyst, to be performed at thre tertiary care     Hospitals in Barcelona.      Subjects: Patients attended consecutively between 2012 and 2013 infected with multi-drug     resistant gram negative bacilli and treated with colistin.      Sample size: 142 cases. Intervention: Once detected the infection requiring treatment with     colistin, patients will be randomized to receive the intervention or not, with a 1:1 ratio.     The intervention will be performed by an Infectious Diseases physician and will consist in a     recommendation on the dose of colistin based on its plasma levels 48 hours after treatment     onset.      Variables: peak and through colistin levels 48 hours after treatment onset, clinical,     analytical and microbiological data at baseline and during follow-up of the patients.      Outcome measures: clinical, microbiological and toxicity data. Analysis: Comparison of     patient characteristics and outcome variables between patients who had received the     intervention and those who had not. The analysis will be done by intention to treat, by     biological effectiveness and by compliance with the protocol.   "
110071|NCT01845233|"     The purpose of this study is to determine whether clinical examination, report from     ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as     screening tools to reveal clinical relevant problems with patients receiving long term     treatment with non invasive ventilation.   "
110072|NCT01845220|"     This study is designed to determine whether Asians who are especially sensitive to alcohol     exposure can be protected by boosting their activities of an alcohol disposing enzyme. This     will be accomplished by administering broccoli sprouts that are rich in an agent that     increases protective enzyme activity. The test system involves applying alcohol patches to     the skin and measuring skin redness.   "
110073|NCT01845207|"     Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several     tools exist to measure frailty, some based on physical tests and others on questionnaires,     yet there is no agreement on which tool to recommend. This multi-center prospective cohort     study is aimed at comparing various frailty assessment tools to determine which best predicts     death or major complications after cardiac surgery or transcatheter intervention. The     population of interest is elderly patients with severe aortic stenosis undergoing surgical or     transcatheter aortic valve replacement. The frailty assessment tools under investigation     include composite frailty scales, physical performance tests, muscle mass, and biomarker     expression. The overall objective is to improve our ability to predict risk by measuring     frailty using the optimal tool in elderly cardiovascular patients.   "
110074|NCT01845194|"     This human pharmacokinetic study investigates, whether processes of drug metabolism and     transport are determined by genetic or hereditary factors. Therefore, approved drugs are     applied to twins and metabolism and transport processes are investigated.   "
110075|NCT01845181|"     This is a phase I, single-center, randomized, double-blind, dose escalation study without     therapeutic benefit, in which PBF-680 will be administered as single oral ascending dose to     young male healthy volunteers. Up to four different rising doses will be tested in groups of     8 participants. Thus, four groups will participate but each one participating only once. For     each dose level / group the participants will be randomized to active or placebo with 2     participants being randomly assigned to placebo and 6 to the active drug. First, one     volunteer will receive active drug (subgroup 1); after 48h of safety and tolerability     assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after     48h of safety and tolerability parameters assessment a third subgroup of 4 volunteers will     receive 3 active drug and 1 placebo. After evaluation of safety parameters of dose level the     process will replicate one week afterwards in the following dosages.      The aims of this study are:      Primary:      - To assess the safety and tolerability of single escalating oral doses of PBF-680 in young     male healthy subjects leading to the determination of the maximum tolerated dose (MTD).      Secondary:        -  To assess the pharmacokinetics of PBF-680 after single rising oral doses in healthy          young male subjects.        -  To asses the preliminary pharmacodynamic effects.        -  To evaluate the adenosine A1 receptor antagonism in blood samples of healthy volunteer          caused by the PBF-680 administration   "
110647|NCT01837719|"     The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir     in a fixed-dose combination with cobicistat with that of atazanavir coadministered with     cobicistat as single agents.   "
110076|NCT01845168|"     The purpose of this study is to investigate if a computerised decision-support tool used in     general practice, can reduce the frequency of peptic ulcer bleeding related to the use of     NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .      On the basis of The Danish general medical database it is possible to develope a     computerised decision-support tool, which enables the general practitioner (GP) in a pop-up     window to get information on each patients risk-factors, when prescribing NSAID and aspirin     to a patient at risk. This will give the general practitioner the oppurtunity to choose a     different type of preparation or prescribe ulcer-preventive medicine at the same time.      The decision-support tool will be tested in a randomized trial among general practitioners.     The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a     reduction in half of the total numbers of peptic ulcers.   "
110077|NCT01845155|"     BACKGROUND: Tinnitus is a nonspecific symptom of hearing disorder characterized by the     sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Despite a     variety of treatments, many patients with chronic tinnitus ask for more active ways in coping     with their tinnitus. Gold standard treatment in chronic tinnitus is a comprehensive directive     counseling explaining the underlying mechanisms leading to the tinnitus percept. Therefore a     neuro-music therapeutic treatment based on a bio-psycho-social framework was developed and     compared to a counselling-only control group.      INTERVENTION: two standardized protocols for tinnitus therapy were defined (neuro-music     therapy vs. counselling)   "
110078|NCT01845142|"     Vitamin D receptors are expressed in activated different immune cells. It is not known, which     immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals     will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a     double-blind placebo controlled setting. Immune cells will be monitored from the blood over     time.   "
110079|NCT01845129|"     The present study assesses whether language functions in patients with residual post-stroke     aphasia can be improved by transcranial direct current stimulation administered to the     primary motor cortex in the language dominant (left) hemisphere.   "
110084|NCT01845064|"     DM199 (recombinant human tissue kallikrein-1) is a new investigational compound that may     eventually be used for the treatment of Diabetes Mellitus Type 2. This is the first time that     this compound is being given to humans.      The purpose of the study is to investigate to what extent DM199 is safe and tolerated.     Further, it will be investigated how quickly and to what extent DM99 is absorbed and     eliminated from the body (this is called pharmacokinetics). In addition, the effect of the     compound on the body will be investigated (this is called pharmacodynamics).      This study is not intended to improve anyone's health, but is necessary for the further     development of DM199.      The study consists of 4 parts. Each part (A, B, C and D) will consist of one or several     periods. The research will be conducted in healthy male and female volunteers (Part A and C)     and in male and female type 2 diabetes mellitus patients (Part B and D).   "
110085|NCT01845051|"     The researchers investigated the relationship between migraine and allergy. For this purpose,     the researchers designed a controlled study to evaluate nasal symptoms and signs; and to     perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy     subjects. According to these results the prevalence of allergic rhinitis in migraine group     was planned to be compared to that of the healthy controls, statistically.   "
110086|NCT01845038|"     The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug     product, when placed in the canaliculus of the eyelid compares to timolol drops for the     lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular     hypertension.   "
110087|NCT01845025|"     The purpose of this study was to assess whether the risk of serious asthma-related events     (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in     adolescents and adults (12 years of age and older) taking inhaled formoterol     fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone     propionate alone.   "
110088|NCT01845012|"     HDQ 200 is an interventional multicenter study. This is a before-and-after design in which     the patient is his own control. The main objective of the study is to determine the     percentage of success of a procedure of daily hemodialysis at low dialysate flow. All     patients treated with conventional hemodialysis, for at least 3 months and clinically stable,     can be included in the study. Their 3 months data prior to inclusion is collected     retrospectively. These 3 months of conventional hemodialysis are the reference period.     Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During     this 3 months period, the same data as during the period of conventional hemodialysis are     collected prospectively.   "
110089|NCT01844999|"     The purpose of this study is to determine whether using the P3P website can increase     decisional preparation and satisfaction, and decrease decisional conflict, in men deciding     how to manage early stage prostate cancer.   "
110090|NCT01844986|"     Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line     Platinum Based Chemotherapy.   "
110091|NCT01844973|"     This study is to evaluate the pharmacokinetics and safety of M518101 in male and female     plaque psoriasis patients.   "
110092|NCT01844960|"     A double blinded randomised control trial comparing the differences between laparoscopic     single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35).     Single incision surgery is a new minimally invasive surgical technique requiring the surgeon     to operate through one small single incision and is virtually scarless. The traditional     laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports)     across the whole abdomen. This study seeks to identify the risks, benefits and costs of the     adjustable gastric band insertion via single incision and multiple incision within the     morbidly obese patient group.   "
110093|NCT01844947|"     This study aims to analyse the tolerability (side effects and safety) with standard treatment     (Javlor®) with the addition of a second anti-tumour drug: sorafenib (Nexavar®). This is the     first time this treatment combination is studied in humans. Samples of blood, urine and     tumour tissues will be analysed for molecular biomarkers. These biomarkers may potentially     help us in the future in predicting whether a patient will benefit or not from the cancer     treatment. The study also aims to investigate if a newer imaging method, called PET-CT     (positron emission tomography-computed tomography), at an earlier stage (than a normal CT     scan) can identify patients who will benefit from the given treatment.   "
110094|NCT01844934|"     A study comparing the benefits of pre-habilitation exercise to standard care prior to total     knee arthroplasy   "
110095|NCT01844921|"     This is a single center, single arm, open label observational trial of patients undergoing     EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to     position the NvisionVLE catheter to acquire an image of an area of the esophagus to identify     and discriminate abnormal areas of tissue from normal.   "
110096|NCT01844908|"     Postoperative ileus remains a significant medical problem after colorectal surgery that     adversely influences patients' recovery. The investigators previous study demonstrated that     electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of     postoperative ileus and hospital stay after laparoscopic resection of colonic and upper     rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal     excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex     cases are more likely to develop prolonged ileus and morbidity after surgery, and it is     uncertain whether EA will be beneficial to them. The investigators therefore propose to     conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged     ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with     mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will     be recruited. All patients will undergo 1 session (20 minutes) of EA daily from postoperative     day 1 till day 4. These patients will be compared with a matched historical control group     (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is the incidence     of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after     surgery, associated with the need for nasogastric decompression and/or parenteral nutrition     support. Secondary outcomes include time to defecation and duration of hospital stay. Results     of this study will help clarify the efficacy of EA in preventing prolonged ileus after     laparoscopic rectal surgery, and may provide the basis for planning a larger randomized     controlled trial.   "
136706|NCT01495338|"     The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a     placebo.   "
110098|NCT01844882|"     Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline     of renal function associated with increased overall mortality. Most dietary guidelines for     CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods.     However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion     which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review     and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as     classical markers of a state of uremia in individuals with CKD. We hypothesize that     increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.   "
110099|NCT01844869|"     The purpose of this study is to determine the pharmacokinetic and safety profiles of     omacetaxine and its metabolites in patients with relapsed and/or refractory hematologic     malignancies or advanced solid tumors following subcutaneous (sc) administration.   "
110100|NCT01844856|"     This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to     assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in     the treatment of adult complicated intra-abdominal infections (cIAI).   "
110101|NCT01844843|"     Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES),     coverage of the stent struts by new tissue. The evaluation will be performed by means of     intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue     coverage over the implanted stent struts prevents direct contact between blood and     metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs     to prevent these events. Ous new stent has drug and polymer only on the outside of the stent,     and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This     should allow fast coverage of the struts, and might allow to reduce duration of the     supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3     months after implantation, as assessed by OFDI.   "
110102|NCT01844830|"     The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for     inducing pulpal anesthesia of the maxillary teeth in pediatric patients.   "
110103|NCT01844817|"     The purpose of this study is to compare the overall survival in patients with previously     untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or     gemcitabine/nab-paclitaxel plus placebo.   "
110104|NCT01844804|"     In this study, healthy volunteers will receive a single intravenous dose of either     PF-06438179 or infliximab (United States) or infliximab (European Union). During the course     of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the     blood, and by comparing these levels among the different administration arms of PF-06438179     and the licensed infliximab products. Safety, tolerability, and immunologic response will     also be evaluated throughout.   "
110106|NCT01844778|"     The purpose of this interventional Phase IV study was to explore the ease of use of TIP and     prevalence of microbial contamination of the T-326 Inhaler compared with TIS and     colistimethate administered via nebuliser for the treatment of Cystic Fibrosis (CF) patients     chronically infected with P. aeruginosa.      It was anticipated that the data from this study would provide clinicians with further     guidance on the relative differences between the speed and ease of use of these treatments as     well as useful information on the prevalence of microbial contamination of the inhalation     devices in real world use.   "
110107|NCT01844765|"     To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic     myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).   "
110108|NCT01844752|"     This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized     to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and     efficacy will be assessed over the course of the study.   "
110109|NCT01844739|"     This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with     elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or     Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability,     safety, and P. acnes counts.   "
110110|NCT01844726|"     The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13,     an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness     on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.   "
110111|NCT01844713|"     This study is being done to evaluate the effectiveness of a Sun Protection Strategies     workbook for kidney transplant recipients. Since the medication taken to preserve the kidney     transplant puts kidney transplant recipients at an increased risk of developing skin cancer.     The program will help people learn about how to practice effective sun protection after the     transplant.   "
110112|NCT01844700|"     We will conduct a 12-week, randomized open label study, comparing usual care (UC)     antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in     children and adolescents aged 13-18 years old. Patients will have 10 days or less lifetime     antipsychotic exposure and be in clinical need for antipsychotic treatment for a pediatric     psychiatric disorder with FDA indication for antipsychotic use, i.e., bipolar mania,     schizophrenia-spectrum disorders, and irritability associated with autistic disorder. In     addition, we will also include youth fulfilling research diagnostic criteria for severe mood     dysregulation (SMD). Randomization will be stratified by high vs. low genetic risk for     antipsychotic-induced weight gain based on MC4R genotype and the primary outcome will be     weight change from baseline to endpoint between ZIP and UC antipsychotic treatment in each of     the two genotype groups. As detailed below, other metabolic and cardiac safety parameters     will also be measured and compared across treatments in each of the genotype groups.   "
110113|NCT01844687|"     The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400,     800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and     cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when     combined with placebo marijuana, as well as its ability to modulate the behavioral effects of     active marijuana.   "
110491|NCT01839760|"     The objective of the study is virological assessment (e.g., proportion of prolonged viral     shedding, median days to viral clearance, and viral load) in laboratory-confirmed adult     influenza patients admitted to the general ward and/or to the ICU and to assess the     correlation with the clinical manifestations and prognosis.   "
110114|NCT01844674|"     This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of     multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of     tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies.     Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice     daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will     have the option to continue treatment with vemurafenib as part of an extension study     (NCT01739764).   "
110115|NCT01844661|"     The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children     and adults with metastatic and refractory solid tumors. CELYVIR consists in bone     marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic     adenovirus. In addition to data on toxicities the investigators will evaluate clinical     response.   "
110116|NCT01844648|"     To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive     thin films compared to placebo to reduce hypersalivation in PD patients manifesting     sialorrhea complaints.   "
110117|NCT01844635|"     The objective of this study is to evaluate the feasibility and effectiveness of     immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline,     Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia     (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR)     + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include     evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and     EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and     CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse     rate and overall survival.   "
110118|NCT01844622|"     The purpose of the study is to treat patients with on-going slow stomach     emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy   "
110119|NCT01844609|"     The purpose of this study is to determine if an intensive journal club based on articles and     materials provided on the journal Obstetrics and Gynecology Website improves written and     spoken comprehension of medical English in a population of Chinese medical professionals.   "
110141|NCT01844323|"     The particle size of the active ingredient may impact dissolution rate in the gastro     intestinal tract and hence the amount of drug available for absorption. Similarly,     differences in the percentage of the excipients used in the formulated capsules may affect     dissolution rate. The purpose of this study is to estimate the effect that particle size and     percentage of excipients could have in drug absorption, which will improve the manufacturing     process of the formulated capsules.   "
110142|NCT01844310|"     This study is to evaluate the safety and efficacy of RAL-based regimen in     treatment-experienced patients with resistant HIV infection   "
110143|NCT01844297|"     This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate     (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive     Chinese HIV/AIDS patients.   "
110120|NCT01844596|"     Cardiovascular disease (CVD) is the leading cause of death in sub-Saharan Africa among adults     above age 30. The prevalence of hypertension, a major risk factor for CVD, is increasing over     time in sub-Saharan Africa, exerting a significant epidemiologic and economic burden on the     region. Without adequate control of hypertension, its health and economic burden will     increase drastically in the decades ahead. Well established and evidence-based interventions     to manage hypertension exist; however, treatment and control rates are low.      A critical component of hypertension management is to facilitate sustained access of affected     individuals to effective clinical services. In partnership with the Government of Kenya, the     United States Agency for International Development-Academic Model Providing Access to     Healthcare Partnership (AMPATH) is expanding its clinical scope of work in rural western     Kenya to include hypertension and other chronic diseases.      However, linking and retaining individuals with elevated blood pressure to the clinical care     program has been difficult. Thus, the overall objective of this application is to utilize a     multi-disciplinary implementation research approach to address the challenge of linking and     retaining hypertensive individuals to a hypertension management program. We aim to add to     existing knowledge on scalable and sustainable strategies for optimizing control of     hypertension and other chronic diseases in low- and middle-income countries.   "
110121|NCT01844583|"     Safety, tolerability and PK of concomitant esomeprazole and rifampin, and QT study on single     and multiple-doses of alisertib   "
110122|NCT01844570|"     The purpose of this study is to determine whether the effectiveness of levamlodipine maleate     (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a     Chinese primary hypertension population.   "
110123|NCT01844557|"     The goal of this research study is to look for factors that influence whether or not head and     neck cancer patients follow the swallowing exercises that they are asked to perform while     receiving radiation treatment.   "
110124|NCT01844544|"     the purpose of the study is to:        1. Identify and characterize drug related problems in patients after a femur neck fracture          that are hospitalized in the orthopedic department at Meir medical center.        2. Evaluate the contribution of a clinical pharmacist in identifying,characterizing and          preventing drug related problems in patients after a femur neck fracture that are          hospitalized in the orthopedic department at Meir medical center.   "
110125|NCT01844531|"     The primary objective of this trial is to establish bioequivalence of two fixed dose     combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and     low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose     empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin     tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high     fat, high caloric meal.      The assessment of safety and tolerability will be an additional objective of this trial.   "
110126|NCT01844518|"     The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin)     at Day 113 in children and adolescents with pJIA   "
110127|NCT01844505|"     The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with     Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab     alone.   "
110128|NCT01844492|"     One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care     unit (ICU), typically following decisions made by surrogate decision makers to forego life     prolonging treatment. A large body of empirical research has identified deficiencies in care     processes that contribute to three important problems: 1) family members often struggle in     the role of surrogate, 2)leading to lasting psychological distress associated with the ICU     experience patients near the end of life frequently receive invasive, expensive treatment     that is inconsistent with their values and preferences, and 3) end-of-life care is a major     contributor to health care costs.[8, 9] Although advance care planning can prevent some     unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis     is uncertain, and therefore it seems likely that the need for interventions to improve     in-the-moment decisions by surrogates will persist.[10, 11]      The long term goal of the investigators research program is to develop, test, and disseminate     strategies to improve surrogate decision making for incapacitated patients and to mitigate     adverse psychological outcomes among surrogates. In a pilot project, the investigators     developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven     Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives     new responsibilities and advanced communication skills training to existing ICU staff (local     nurse leaders and social work members of the ICU team); 2) changes care defaults to ensure     frequent clinician-family meetings; 3) adds protocolized, nurse-administered coaching and     emotional support of surrogates before and during clinician-family meetings, and 4) increases     use of palliative care services for patients with a poor prognosis. The investigators 2-year     pilot study documented that the intervention is feasible, sustainable, and is associated with     shorter ICU length of stay and cost savings. The objective of this proposal, which is the     next step in pursuit of the long term goal, is to conduct a stepped wedge randomized     controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced     critical illness and their surrogates.   "
110129|NCT01844479|"     In this pilot study, the first objective is to bench test a novel shear reducing insole and     compare it to current standard insoles and shoes. The second objective is to study     twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for     changes in spatial temporal gait including gait initiation, risk of falling, static and     dynamic balance, and plantar temperature response to walking and consecutive plantar stress     in both footwear conditions.   "
110130|NCT01844466|"     This is a prospective study of patients with stroke with accompanying motor and visual     deficits. There will be patients' evaluations at 2 time points at the acute and subacute     period after the stroke. Statistical correlation of the improvement of their deficits will be     conducted   "
110144|NCT01844284|"     Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter,     Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in     the treatment of subjects with ischemic heart disease caused by de novo native coronary     artery lesions in Japanese population by comparing to approved metallic drug eluting stent.   "
110156|NCT01844128|"     Obesity affects on fertility. Obese women have lower pregnancy rate after infertility     treatments.They need more doses of hormone during ovarian stimulation, more days for     stimulation. During IVF treatment less oocytes are collected and the quality of embryo also     harmed.      The first line treatment for those women with obesity and infertility is weight loss.      The investigators' hypothesis is that weight reduction improves ovarian reserve and fertility     treatment outcome.   "
110157|NCT01844115|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone     relative to placebo in the treatment of generalized anxiety disorder (GAD).   "
110131|NCT01844453|"     The application of in-vitro fertilization (IVF) has provided remarkable opportunities for     infertile couple to conceive in the last four decades. Historically IVF was performed for     patients with bilateral tubal obstruction, but its use is presently widespread. Although the     efficacy of assisted reproductive technology continues to improve, endometrial implantation     remains the limiting step towards a successful pregnancy. Reduced endometrial receptivity and     embryonic defects are the probable primary causes of implantation failure during IVF(1).     Patients with repeated implantation failure despite transferring good-quality embryos     continue to be a major dilemma for clinicians and are a topic of great research interest.     Barash et al. unintentionally discovered and initially reported that an endometrial biopsy     prior to IVF in women who have had one or more implantation failures was associated with an     increased clinical pregnancy (66.7% vs 30.3%, p<0.01) and live birth rates 48.9% vs 22.5%,     p=0.02) compared to a control group(2). The mechanism by which a local endometrial injury     (LEI) may increase the pregnancy rate is still not fully clear. Possible etiologies include     its role in promoting a beneficial local inflammatory response, inducing endometrial     decidualization, or improving endometrial maturation synchrony (3-6).      Following Barash et al's publication, several randomized controlled studies confirmed their     findings (7-11). However, there has been extensive heterogeneity among studies, including the     number of biopsies, how the biopsy is performed and the selected patient population. On the     other hand all the studies have in common that the endometrial biopsy was performed prior to     the start of the IVF cycle.      The optimal timing of an endometrial biopsy with respect to an IVF cycle is unknown. There is     reason to suspect that an endometrial biopsy during the follicular phase of an IVF     stimulation cycle may improve pregnancy outcomes, although this has not been directly     examined. We therefore propose a randomized controlled study to evaluate the impact of an     endometrial biopsy on the implantation and pregnancy rate in both the luteal phase prior to     the IVF cycle as well as the follicular phase of the concurrent IVF cycles.   "
110132|NCT01844440|"     The aim of this study is to establish and validate High resolution manometry (HRM) criteria     for the definition of transient lower esophageal sphincter relaxations (tLESRs) in     gastroesophageal reflux disease (GERD) patients.   "
110133|NCT01844427|"     This is a 12-week clinical trial evaluating the efficacy and safety of memantine     hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function     deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). After     screening procedures, memantine is prescribed in randomized, double-blind fashion (equal     chance of medication or placebo) for 12 weeks.      The investigators hypothesize that memantine hydrochloride will prove to be an effective,     safe, and well-tolerated agent for the treatment of EFDs in individuals with ADHD interested     in non-stimulant medications.   "
110134|NCT01844414|"     The purpose of this study is to conduct a prospective, three-group study that randomly     assigns 700 parolees, in a community residential drug treatment program, to enter one of     three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes     nurse case management and specialized hepatitis education sessions and the hepatitis A/B     (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by     cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP)     Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and     coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief     general health information, one-on-one coaching and the HAV/HBV vaccine.   "
110135|NCT01844401|"     The primary objective of this study is to compare the pharmacokinetic (PK) profiles of     Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg     albuterol base from each product.   "
110136|NCT01844388|"     This study will compare the safety and efficacy of a new carboxymethylcellulose based eye     drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.   "
110137|NCT01844375|"     This prospective randomized controlled study is designed to investigate whether preoperative     oral carbohydrate loading improves postoperative walking performance, a surrogate indicator     for overall functional recovery, in patients undergoing colorectal surgery as measured by     2-minute and 6-minute walk test. The secondary outcomes are postoperative insulin resistance     measured with plasma insulin and glucose concentrations. The tertiary outcomes are duration     of hospital stay, patients satisfaction during staying in the hospital and morbidity measured     as postoperative complications.   "
110138|NCT01844362|"     Uterus transplantation, as a possible future treatment for uterine factor infertility, has     been developed in animal species during the last decade.      The study protocol includes transplantation of the uterus from a live donor (mother,     relative, friend) into women with absolute uterine factor infertility (lack of uterus from     birth or due to life saving hysterectomy).The recipient will be treated by standard     immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted     when at least 12 months have passed from transplantation. Approval for a case series     including up to 10 patients has been acquired.   "
110139|NCT01844349|"     Problematic and state of the art Obesity and its associated non communicable diseases (NCDs)     are rising rapidly in middle income countries, such as those in the Maghreb (North Africa).     This progression is related to the context of a nutrition transition (changing food and     physical activity environment) and profound changes in technological advances and in society.     These societies and their health systems are insufficiently prepared for this evolution,     which has enormous health and socioeconomic consequences. In the context of limited     resources, the priority has been given on an international level to prevention. But several     problems arise: - these countries are still confronted by undernutrition in terms of     micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level     and also individual level. Known as the 'double burden', this coexistence is relatively new     and has been rarely documented until recently. Educational measures could be ineffective in a     society where cultural norms do not recognise obesity and where changes in lifestyle are     possibly not seen as acceptable. As well as information about citizen's knowledge of risk     factors, data on their perceptions and attitudes are indispensable. Policies that involve     changing the 'obesogenic' environment that individuals occupy is a priority.      Objectives of the project Overall aim: to contribute to the development of preventive     strategies for obesity and chronic NCDs in the context of a nutrition transition.      Specific objectives: characterise the nature and size of the double burden     (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of     biological and behavioural risk factors; characterise the psycho-sociocultural determinants     of behaviour.   "
110140|NCT01844336|"     The purpose of this study is to evaluate the performance of the PBASE system, in terms of the     efficacy of treatment in patients with idiopathic rhinitis.   "
110192|NCT01843660|"     The purpose of this study is to evaluate the efficacy and safety of tramadol     hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to     severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to     the bones) outpatient or emergency setting.   "
110145|NCT01844271|"     Muscle fatigue and muscle recovery after exercise are recent areas of research involving Low     Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and     application parameters, mechanisms of action, effects on long-term exercise and the long-term     effects on skeletal muscle recovery.      The present research project aims to assess the effects of long-term recovery of LLLT in     skeletal muscle after exercise and identify the optimal dose application of LLLT.      After defining the best dose of application, we recruited two groups which will be irradiated     with different power, 100mW and 400mW in order to seek the optimal parameter of low level     laser therapy in performance.      The investigators believed that the Low Level Laser Therapy can delay the physiological     process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from physical     effort and accelerate muscle recovery after exercise.   "
110146|NCT01844258|"     Pediatric cataract is totally different from adult cataract. There is traditionally no     difference in technique between pediatric and adult cataract surgery. Opacification of the     visual axis was the most frequent complication after pediatric surgery. In this clinical     study, the investigators aimed to evaluate the safety and postoperative recovery of a     modified technique for pediatric cataract surgery.   "
110147|NCT01844245|"     Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are     suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage     is accepted approaches for the relief of jaundice in malignant biliary obstruction. But     restoration of bile flow have few improvement of the survival of cancer patient. By using     endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth,     which might improve the survival of patients. The feasibility and safety of this technique     using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled,     multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve     the median survival of patients with unresectable biliary malignancy.   "
110148|NCT01844232|"     Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose     escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release     Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this     study will receive arbaclofen in the extended release tablet formulation.   "
110149|NCT01844219|"     Acute kidney injury after cardiac surgery has been reported to increase morbidity and     mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac     surgery have been developed. However, predictive accuracy of these models is stil unclear.     The aim of this study is to evaluate the accuracy of four pre-existing prediction models     using a gray zone approach in patients who underwent aortic surgery in our institution.   "
110150|NCT01844206|"     The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen     for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes     scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that     administration of a second dose of epidural morphine 3 mg, 24 hours after an initial     intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours     after surgery, compared to a single epidural morphine dose regimen. The primary outcome will     be the amount of intravenous morphine patients self-administer during the 2nd 24 hours     post-surgery.   "
110153|NCT01844167|"     Chronic cervical pain is a common problem in rehabilitation clinic, but the treatment is time     consuming and the effect unsatisfactory. Noxipoint® Therapy, developed by Dr. Charles C. Koo,     is a unique electrical stimulation precisely on corresponding Noxipoints® of each injured     soft tissue, with specific duration and intensity of TENS that induce C-fiber nerve ending     sensation. Each application typically last for 2 to 5 minutes. Based on observations of the     clinical application, Noxipoint® Therapy appears to relieve chronic neck and shoulder pain     significantly with lasting effect, and effectively improves the range of motion. However,     large-scale double-blinded, randomized control study on the therapy is not available yet.      The purpose of this study is to compare the effect of Noxipoint® Therapy and physical therapy     (including the current TENS application) on patients with chronic neck pain. This study is a     prospective stratified randomized control trial. Eighty subjects with chronic cervical pain     will be recruited from the Rehabilitation Department or the Physical Therapy Center of     National Taiwan University Hospital (NTUH). The qualified subjects will be stratified and     randomly allocated into two arms, 40 persons in each:        1. Physical Therapy group (PT)        2. Noxipoint Therapy group (NT) Subjects in either group will be treated for up to 6          sessions within 3 weeks, about 1.5 hours per session. The treatment will terminate after          six sessions or earlier if the patient shows no symptoms.      Subjects will be evaluated before and after the first treatment session and followed up at     about 4 weeks, 8 weeks, and 12 weeks after the first treatment.      Outcome measures are (1) the pain scale in the Brief Pain Index, (2) cervical Range of Motion     (ROM), (3) Quality of Life (QoL) measured with the Interference of Pain to Life section in     the Brief Pain Index (BPI) and (4) ultrasound elastogram. Pain scale, ROM and QoL measures     will be taken before and after the first treatment session, and at 4 weeks, 8 weeks and 12     weeks after the first session. Elastogram will be taken before the first treatment, and about     four weeks after the first treatment.      Statistics: The effects of PT and NT will be compared based on two-sample hypothesis testing     methods. All the estimated P-values are two tailed.   "
110154|NCT01844154|"     Osteoporosis is a prevalent health concern among older adults and is associated with an     increased risk of falls that can cause fracture, injury or mortality. Identifying the factors     related to falls occurring within this population is essential for the development of     effective regimes for fall prevention. Studies have shown that muscle quality and good     posture alignments are critical for balance control in older adults. People are diagnosed     with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading     vertebral, fractures and poor balance control, even falls. Therefore, improving muscle     quality, strengthening weak muscles and correcting postural alignment are essential elements     for fracture and fall prevention in older adults with osteoporosis. The long-term objectives     of this work are to prevent fracture and fall in older adults with osteoporosis by improving     the function of degenerative muscles using exercise training.   "
110155|NCT01844141|"     To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70%     alcohol in the surgical treatment of ingrown toenails.   "
110193|NCT01843647|"     The purpose of this study is to evaluate the overall response rate and disease free survival     for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.   "
110158|NCT01844102|"     The study will measure the incidence of moderate and severe adverse events (AEs) associated     with PrePex procedures among 500 men, including both procedural and post-procedure events,     and all device-related incidents such as dislodgment. To assure complete ascertainment of     AEs, study-specific forms will be used to collect standardized data from the circumcision     visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and     will transition to follow-up at two visits (7 and 42 days) for the remaining 450 cases.   "
110159|NCT01844089|"     The broad objective of the study is to determine if the Bakri Postpartum Balloon is effective     in preventing morbidity and mortality from postpartum hemorrhage (PPH) as part of a     standardized management algorithm.      Specific Objectives        -  To estimate the rate of morbidity (including operative intervention and peripartum          hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of          a standardized protocol for management of PPH, but prior to the inclusion of the Bakri          Postpartum Balloon as part of the protocol.        -  To estimate the rate of morbidity (including operative intervention and peripartum          hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of          a standardized protocol for management of PPH, after the inclusion of the Bakri          Postpartum Balloon as part of the protocol.        -  To compare morbidity        -  To generate preliminary data for (a) a larger confirmatory study of the use of the Bakri          Postpartum Balloon in centers with surgical and blood transfusion services, and (b)          design of a pilot study of the use of the Bakri device of temporary control of PPH in          settings outside of surgical centers (such as by trained midwives or emergency transport          personnel).   "
110160|NCT01844076|"     Establish the tolerability and safety of aimed dose of both quinacrine and capecitabine in     combination to treat patients with advanced colorectal adenocarcinoma.   "
110161|NCT01844063|"     HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with     massive necrosis of liver cells. Liver transplantation might be the most effective therapy     for HBV-LF. However, there are a lot of problems such as lack of donors, surgical     complications, transplant rejection, and high cost, which could limit the application of     liver transplantation. It is demonstrated that mesenchymal stem cells could directionally     differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce     inflammation of the liver by immune regulation. In this study, we assess the safety and     efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for     patients with HBV-LF.   "
110162|NCT01844050|"     Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome     differentiation treatment of Traditional Chinese medicine.   "
110163|NCT01844037|"     This is a multi-center, prospective registry designed to monitor the outcomes of renal     denervation with the OneShot Device in a real-world patient population.   "
110188|NCT01843712|"     Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of     hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link     these measurements with individual characteristics (adiposity, age, gender) and parental     feeding practices.      Design: Three consecutive weeks an identical lunch was served in four preschool canteens     reaching 236 children. The first lunch was a control session. For the CC situation (week 2),     thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH     situation (week 3), ten minutes after lunch children were exposed to palatable foods (430     kcal). Food intake was measured at the individual level. Parental eating behaviour and     feeding practices were measured by questionnaires. Child's height and weight were measured by     a medical doctor.   "
110896|NCT01834417|"     Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device.     During this period, patients write in an agenda noteworthy events that could occur while     they're using their wheelchair. A control is done every week and the device can be changed     until it is returned at the end of the study period.   "
110164|NCT01844024|"     Uganda is one of the countries with highest fertility rate in the world, 6.7 children per     women. It is estimated that 56 percent of all pregnancies are unintended and the     contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and     induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and     mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units     in Uganda due to unsafe abortion is reported and considered high in international comparison.     Studies have revealed that trained midlevel providers can deliver safe post abortion care     (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue     misoprostol has been shown to be an effective tool in the treatment of incomplete abortions.     This option is so far under-used in developing countries, especially outside the larger     hospitals and private clinics. One significant limiting factor in providing safe PAC is the     lack of providers. So far technical training has been mainly limited to physicians. The     long-term goal of this project is to provide evidence based information that will contribute     to the development of strategies to increase women's access to high level post- abortion care     at primary health care level provided by midlevel providers in Uganda. A task shift to     midlevel provider in providing treatment of incomplete abortion will increase access to safe     PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete     abortion remains underused and in accessible to a majority of women in Uganda because     national regulations restricts its prescription and supervision to doctors. However, the     safety of misoprostol treatment should make it amenable to provision by midlevel providers.     Training of midlevel providers in misoprostol treatment of incomplete abortion will support     task shifting in places where doctors are costly and scarce. By evaluating the effectiveness     of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion     the project is attempting to contribute to the reduction of maternal mortality and morbidity     and safeguard high quality of post-abortion care. A direct economic impact can also be     expected due to reduced treatment costs of complications from unsafely induced abortion and     incomplete abortions. The involvement of midlevel providers in medical treatment of     incomplete abortion has previously not been systematically evaluated in African primary     health care setting.   "
110165|NCT01844011|"     The purpose of the study is to find out the best way to help pregnant women keep track of     their baby's movements. During pregnancy, feeling your baby's movements is normal. A decrease     in movement can indicate potential problems with your baby's well-being. This study will see     if daily electronic reminders and kick count charts help women to better track their baby's     movements over the last weeks of pregnancy.   "
110166|NCT01843998|"     The purpose of this study is to determine whether sirolimus reduces the symptoms of cutaneous     T-cell lymphoma (CTCL) and whether it causes any side effects.   "
110167|NCT01843985|"     Patients diagnosed with Stage IV cancer (solid tumors only) are evaluated to determine     whether they are candidates for traditional chemotherapy. If eligible, patients are offered     traditional chemotherapy, low-dose chemotherapy, or palliative care. If ineligible, patients     are offered low-dose chemotherapy or palliative care. Patients will be monitored for 5 years     and survival data recorded.   "
110168|NCT01843972|"     To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single     rising doses of BI 691751 in healthy male subjects (part I).      To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution     (part II)   "
110169|NCT01843959|"     A cross-sectional study investigating the aetiology, mechanisms and associated complications     contributing to obesity and diabetes within the UAE population. The study will be carried out     in two main sample populations; children and adults, and characterized by the occurrence of     obesity and diabetes. The main samples will then be divided into a subgroup for metabolomic     analysis. Patients will be recruited from the Imperial College London Diabetes Centre. The     study is aimed at elucidating the various factors that have an impact or may influence     obesity and diabetes in the Emirati population.   "
110170|NCT01843946|"     Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia     and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory     diseases. To explore the potential therapeutic benefit of roxithromycin in chronic     prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of     roxithromycin with ciprofloxacin and aceclofenac.   "
110171|NCT01843933|"     Background: Due to the lingering effects of general anesthesia and the administration of     medications for pain after surgery, children in the recovery room are at risk for breathing     problems. While there are less data specific to children, in general 25% of patients in the     recovery room experience complications from anesthesia. The most common complications involve     the patient's airway and their ability to breath adequately. Currently, checks of oxygenation     with a pulse oximetry monitor and of respiration through nursing assessments are used to     detect breathing problems. However, these are believed not to be adequate for reliably     recognizing significant respiratory depression until other dangerous events develop such as     the cessation of breathing, severe drops in oxygen levels, or cardiac arrest. Capnography is     a monitoring device that measures the amount of carbon dioxide being exhaled and assesses the     adequacy of respiration. A small plastic cannula sits at the base of the nose and on the lip     to continuously monitor the patient's breathing. Most children tolerate this device well and     staff consider it easy to use. While capnography is routinely used in the operating room to     monitor breathing, it is not used during post-operative care when patients are still at risk     of breathing problems.      Objectives: To determine if capnography can detect problems with breathing faster and more     often than traditional monitors. To determine if the addition of capnography to routine     monitoring will decrease the numbers of additional adverse events that occur in children     undergoing post-operative care by allowing nurses to intervene in care faster and more     frequently.      Methods: In the first phase of this study, the investigators will apply the capnography     monitor to children in the recover room and determine how often they experience breathing     difficulties measured by this device. In the second phase, the investigators will educate     staff on the use of capnography and what values are considered abnormal. Children will again     have the capnography cannula placed on them as they enter the recovery room. They will then     be divided into two groups - in one group the nurses in the recovery room will have access to     the capnography monitor for their patients, whereas in the other group the nurses will not be     able to see the readout from the monitor. The investigators will determine if children have     fewer breathing problems and less additional adverse events when nurses use capnography in     addition to the routine monitors already in place in the recovery room as compared to when     nurses use standard monitoring alone.      Potential Impact: If capnography can detect breathing problems prior to being identified by     current monitoring devices, staff may be able to intervene more quickly and before more     serious events occur in the children receiving post-operative care. This can reduce adverse     events, improve patient safety, and avert harm in children. The adoption of this device for     routine monitoring of post-operative care has the potential to save lives.   "
110172|NCT01843920|"     A controlled clinical study comparing the effect of topical aqueous suppressants on     intraocular gas duration.   "
110173|NCT01843907|"     Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive     interventions on readmission rates, loss of functions, quality of life and cost-benefit.   "
110174|NCT01843894|"     Objectives:      Primary        -  To determine the safety and tolerability of escalating doses of RU-101 for 4 weeks in          patients with severe dry eye      Secondary        -  To explore the efficacy of RU-101        -  To explore optimal endpoints for future studies   "
110175|NCT01843881|"     The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can     affect insulin secretion after meals. The hypothesis of this study is the Disposition Index     is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by     glucagon-like peptide-1 (GLP-1) receptor blockade.   "
110176|NCT01843868|"     The incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in patients     receiving R-CHOP chemotherapy for in non-Hodgkin's lymphoma is not well documented. The     contribution of prednisolone to CINV control in the R-CHOP regimen is also unclear.      This study aims to evaluate the overall effectiveness of antiemetic control using a     standardised 5HT3 (5-Hydroxytryptamine 3) antagonist-containing regimen (e.g. ondansetron) in     a heterogeneous group of patients receiving R-CHOP chemotherapy (Rituximab Doxorubicin     Vincristine Cyclophosphamide Prednisolone).   "
110179|NCT01843829|"     About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less     than a quarter have resectable disease at diagnosis. There is a general lack of consistency     in the standard of care for patients across UK hospitals. Patients are either treated with a)     chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by     removal of the tumour by surgery, as part of their standard of care. Recent research supports     the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and     preventing the disease from spreading than taking chemotherapy alone. However, there is no     definitive way of identifying which treatment is best without a clinical trial.      Evidence suggests that the effect of the chemoradiotherapy currently used as standard     practice may be improved and the side effects reduced by using a different chemoradiotherapy     combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy     before being randomised to receive two different chemoradiotherapy regimens (carboplatin and     paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in     previous studies. Patients will then have their tumour removed. The best chemoradiotherapy     regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be     compared with chemotherapy alone.      The efficacy of the regimens will be measured by counting the number of patients who i)     remain free from cancer, ii)have local or distant spread of their cancer, iii) are     successfully recruited and iv) experience toxicities. A specific set of toxicity criteria     will be used to monitor any treatment induced side-effects and provide justification for any     necessary dose modifications or withdrawal of treatment.   "
110180|NCT01843816|"     Tragus-to-wall distance (TWD) measurements is a method to evaluate spinal mobility in     ankylosing spondylitis (AS) patients and it also takes place in Bath Ankylosing Spondylitis     Metrology Index (BASMI). Being obese or slim may affect TWD. As well as the person's losing     or taking weight may lead wrong evaluations, in comparative studies, according to the height     or weight uneven distribution of groups may affect the results. The aim of this study is to     investigate whether the body shape affect TWD or not.   "
110194|NCT01843634|"     This is an open-label pilot study evaluating the safety and preliminary evidence of a     therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard     induction and consolidation therapy for acute myeloid leukemia.   "
110208|NCT01843452|"     There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal cancer     and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR antibody     Panitumumab to chemoradiotherapy seems therefore solidly justified. This trial investigates     concurrent panitumumab/capecitabine/mitomycin concurrent to IMRT-radiotherapy. Treatment     components used in this study have been selected on scientific rationale. The trial regimen     should be feasible with acceptable toxicity and outcome similar to historic series.   "
110181|NCT01843803|"     This study will use a multi-phase mixed-methods approach to develop and test a patient     inventory to facilitate patient-centered care delivery. In Phase I the investigators will     identify which factors should be considered for inclusion in the patient inventory. This will     involve qualitative data collection with providers and patients using interviews and focus     groups, respectively; and developing a question repository. The interviews and focus groups     will take place at the six study sites: Hines VA Hospital and two Community Based Outpatient     Clinics(CBOCs) in LaSalle, IL and Kankakee, IL; Jesse Brown VA Medical Center; and two CBOCs     in Crown Point, IN; and Chicago Heights, IL. The question repository will involve a research     assistant (RA) performing a literature review to gather items related to areas of patient     context.      Phase II will develop and test an item inventory using a Delphi panel - a panel of     stakeholders including Veteran representatives, VA providers, researchers and representatives     from the investigators' operations partners. The panel of at least 14 respondents will     develop a questionnaire through three rounds of email exchanges ranking the list of items to     be included in the patient inventory. Once the patient inventory is finalized, it will be     integrated into an iPad application for patient use.      In Phase III the investigators will test the patient inventory in a randomized trial.      The investigators will conduct a randomized trial of the patient inventory to a control     condition (e.g., healthy living video) to assess whether use of the inventory results in care     that is more patient-centered and decisions that are more collaborative. Eligible     participants will be identified and recruited from the Patient Aligned Care Team (PACT)     clinics at Hines and Jess Brown VA facilities. Patients will be randomly assigned to either     complete the patient inventory on the iPad or watch a health video on the iPad. Patients in     the Intervention group will give a copy of the summary of the inventory to their provider.     Both groups will be asked to carry a concealed tape recorder during their visit. Following     the visit, patients in both groups will complete a set of questionnaires about the encounter     including the CARE and CCM. The recordings will be analyzed by the team using a coding system     developed in a previous Health Services Research and Development (HSR&D) study to see if the     use of the patient inventory facilitated patient-centered care during the encounter. A second     coding scheme, the Informed Decision Making (IDM) will also be applied to examine     collaborative decision making.   "
110182|NCT01843790|"     The primary objective of this study is to compare the change in estimated glomerular     filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The     secondary objective is to determine the safety and tolerability of GCS-100 administered for 8     weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on     circulating galectin-3 and other markers of disease activity.   "
110183|NCT01843777|"     The purpose of this study is to compare two different ways of helping first-time hearing-aid     users get the most out of their hearing aids and determine if one method is better than the     other. One method provides the patient with routine information regarding the care and use of     hearing aids the other method uses tools to address patient-specific barriers against and     motivators for hearing-aid use.   "
110184|NCT01843764|"     The aim of the study was to follow clearance of malaria infections and detection of new     malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this     purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on     Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and     one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children     during 42 days.   "
110185|NCT01843751|"     The proposed work addresses critical health and public safety issues in the U.S. and in     Wisconsin: the intersection of addiction and crime and the prevention of associated     individual and public health complications. The results will provide justification for the     expanded involvement of primary care in the treatment of substance-related disorders (opioid     dependence in particular) and the prevention of their complications. As such, the project     answers to federal calls for the expansion of substance abuse treatment into primary care     settings and to objectives within the Alcohol and Drug Focus Area of Healthiest Wisconsin     2020.   "
110186|NCT01843738|"     Patients are being asked to take part because they have melanoma that has spread to other     organs in their body (metastatic). As part of this study, patients will receive radiation     therapy and an approved drug (Vemurafenib).   "
110897|NCT01834404|"     Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric     emptying, gastric accommodation, satiety, and satiation in obese participants.   "
110189|NCT01843699|"     Objectives: Pathological gambling (PG) is a prevalent disorder with no approved     pharmacological treatment. Previous reports suggest that topiramate could be useful in     reducing impulsivity in PG, and craving in other addictions. The goal of this study was to     investigate the effectiveness of topiramate combined with brief cognitive restructuring in     treating PG. Methods: 38 PG patients were randomized to either topiramate (N=18) or placebo     (N=20) in a 12-week double-blind trial; all patients received brief cognitive restructuring.     The main outcome measures were craving, gambling behaviour, gambling cognitive distortions,     impulsivity, depression and social adjustment.   "
110190|NCT01843686|"     This study will demonstrate the safety of the application of autologous platelet rich plasma     (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree     burns. The study will be a randomized, double-blinded controlled safety study. Investigators     expect that the PRP will deliver improved hemostasis and growth factors at the wound site     thus increasing the effectiveness of treatment at the wound site. This will lead to rapid     production and delivery of an autologous therapy that should minimize additional morbidity to     the patient.   "
110191|NCT01843673|"     This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during     treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high     quality imaging technology to detect the tumor and normal organs during treatment. It is not     yet known which imaging technique provides the best image for guidance during treatment with     radiation therapy. Comparing results of imaging procedures done before, during, and after     radiotherapy may help doctors plan the best treatment.   "
110648|NCT01837706|"     The purpose of this study is to observe whether people would report being less likely to sue     a physician who shows more empathy when giving a patient potentially bad news regarding their     medical condition.   "
110195|NCT01843621|"     The purpose of this study is to find out more about the two doses of dengue vaccine, over a     five year period, that the children received in the Dengue-003 study and to study a third     dose of dengue that will be given to the children        -  Do children still have dengue antibodies intended to provide protection against dengue          infection one year after the two doses of vaccine given in study Dengue-003?        -  Were there any major medical problems that appeared as dengue-like symptoms during the          one year after vaccinations?        -  Will a third dose of dengue help to further stimulate the part of the immune system          intended to help protect against dengue infection?        -  Is a third dose as safe as the first two doses?        -  Are the local reactions to a third dose of the vaccine similar to what your child          experienced after the first two doses?   "
110196|NCT01843608|"     Breast cancer survival it is affected by the side effects related to the illness, the     treatments or even the behavioral factors (e.g. inadequate diet, sedentary behavior) that     create in this women an important quantity of psychological and physical disorders. Prior     systematic reviews and meta-analyses have demonstrate that supervised aerobic training is a     safe, feasible, and effective adjunct therapy to improve a broad range of physiological and     psychological outcomes in women with early breast cancer. However the vast majority of     studies to date have focused on the efficacy of exercise to improve symptom control outcomes     in breast cancer patients either during or following the completion of adjuvant therapy.      Most relevant consequences are found in women that have to undergo surgery as 16% to 43% of     women with breast cancer suffer functional limitation in the shoulder, inflammation, pain or     strength and flexibility reduction in upper body limbs one year after surgery with a high     prevalence which is rising.      Weight gain is associated with decreased quality of life and increased risk for several     comorbid conditions, such as cardiovascular disease and diabetes. The most of the     cardiopulmonary problems are induced by chemotherapy or radiotherapy, because of the     treatments effect in the heart and its consequences in cardiorespiratory fitness of these     women.      These side effects become in important limitations to allow women return their normal life     style. These limitations have a severe effect in decreasing of physical activity practice,     which have visible consequences in increasing general fatigue and calcium deficiency in bones     due to the age and some adjuvant treatments.      Previous studies found that patients with breast cancer who gained modest amounts of weight     were significantly more likely to experience disease recurrence and die from breast cancer     and other causes that those who were weight stable. In addition, two thirds of the studies     that have assessed body composition change in relation to weight gain in this patient     population observe no net gain in muscle mass or loss in muscle mass as body weight and     adipose tissue increase. These changes are defined as sarcopenic obesity. This kind of     obesity is characterized by weight gain in the presence of lean tissue loss or absence of     lean tissue gain. In addition fat tissue gain is related with other health disorders such as     diabetes, functional limitations and poor survival levels. Treatment for this unique pattern     of weight gain is an exercise intervention, especially strength training.      Psychological effects have to be took account as cancer produce important aftermath. Large     scientific evidence shows the psycho-emotional alterations in women diagnosed with breast     cancer at some point in their life.      World Health Organization (WHO) defines quality of life as individuals perception of their     position in life in the context of the culture and value systems in which they live and in     relation to their goals, expectations, standards and concerns. It is a broad ranging concept     affected in a complex way by the person's physical health, psychological state, level of     independence, social relationships, personal beliefs and their relationship to salient     features of their environment. Following this definition numbered of researches have been     developed, presenting interest in both physiological and psychological changes and     improvements, as show different studies.      HYPOTHESIS The primary hypothesis of this study is that group exercise intervention,     combining aerobic and strength training, will reduce lean mass and body fat tissue in breast     cancer post treatment survival.      Secondary hypothesis of this clinical trial are follows:        1. Combined exercise intervention will increase maximal strength level of chest press and          leg press.        2. Combined exercise intervention will increase maximal cardiopulmonary capacity, assessed          by Peak Oxygen Consumption(VO2peak), which has been confirmed as an important value in          survivals. In addition, ACSM propose this value as the Gold Standard to assess fitness          level.        3. Combined exercise intervention will increase global Isometric Strength Index, assessed          by Grip Strength Dynamometer.        4. Combined exercise intervention will improve range motion in upper-limbs.        5. Patients Reported Outcomes (PROs), such as quality of life (QoL), Health perception and          depression.   "
110197|NCT01843595|"     The purpose of this study is to test the effect of a new three-month behavioral weight loss     program among adult men. Weight will be measured at three and six months post randomization.     The intervention will be compared to a wait-list control group. Participants will be 112     overweight and obese men (18-65) living in the Chapel Hill/Raleigh/Durham area. The     behavioral intervention tested will be delivered online with two face-to-face group meetings.     Intervention content will be delivered via email and online. It is hypothesized that men     randomized to the REFIT intervention will lose more weight at 3 months than men randomized to     the wait-list group.   "
110198|NCT01843582|"     The study is aimed to develop a new reaction-time based method for examining the visual field     and to study the effect of refractive error on the magnification of a fundus photograph in     order to evaluate the true size of a retinal feature.   "
110199|NCT01843569|"     We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection     combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected     population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk     of ovarian hyperstimulation syndrome.   "
110200|NCT01843556|"     A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and     pharmacokinetics.   "
110201|NCT01843543|"     Urgency Incontinence (where the bladder muscles contract suddenly, causing an immediate urge     to urinate that is difficult to prevent) is commonly experienced in patients with overactive     bladder. New findings have discovered that urgency incontinence may be connected to the     interactions of certain regions of the brain and the bladder. Although this is a common     problem, researched still do not know how these interactions impact the process of urgency     incontinence. Furthermore, there is preliminary data to suggest that interventions such as     Mindful-Based Stress Reduction (MBSR) can potentially be used as therapy for UI. The purpose     of this study is to determine the impact MBSR training on UI symptoms, quality of life, and     anxiety measures.   "
110202|NCT01843530|"     This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert     for treatment of ACE induced Angioedema.      This study should show that Berinert shortens the time to complete resolution of signs and     symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when     given on top of standard treatment. This study should also compare the time to onset of     relief as defined by an at least one point reduction on the severity scale of ACE-induced     angioedema with Berinert versus placebo.   "
110203|NCT01843517|"     This study seeks to further understand these three observations - (1) that the time period     surrounding childbirth accelerates recovery from pain after injury (2) that this likely     reflects dampened facilitating mechanisms and exaggerated inhibitory mechanisms, and (3) that     stress may interfere with this protection. In this study the investigators will compare women     within 2 weeks of delivery to age matched controls and anticipate that pain inhibition is     increased after delivery, pain facilitation is decreased, and that there is a relationship     between these pain responses and the degree of pre-existing stress.   "
110204|NCT01843504|"     The goal of this study is to find an effective treatment for chronic patellar tendinopathy     (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine     whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with     correlation to a new method of ultrasound (US) imaging assessment called Acoustoelastography     (AE). Positive findings of PRP compared to control would suggest future larger scale studies     to help establish an optimal protocol for the nonsurgical management of PT.   "
122562|NCT01681719|"     this study aims evaluate the ergospirometric values after 03 months of training with WBV in     elderly health people. The hypothesis is increases of ergospirometric values.   "
110205|NCT01843491|"     This is an open label Phase 1 study of the Ad-PfCA vaccine designed to 1) provide reagents     for the development and refinement of cell-mediated immunoassays for measuring the human     immune response to candidate malaria vaccines (especially protective malaria vaccines such as     DNA/Ad-PfCA where better assays are needed to identify the correlates of protective immunity)     and 2) to provide a repository of antigen-specific PBMCs that can be used as positive and     negative controls in cell mediated immunoassays.   "
110206|NCT01843478|"     Cervical cancer is the second most common type of cancer among women worldwide. Women with     human immunodeficiency virus (HIV) bear a disproportionate burden of cervical cancer and its     precursor, cervical intraepithelial neoplasia (CIN), that result from persistent high-risk     Human Papillomavirus (HPV) infection. HIV clinical practice guidelines recommend two Pap     tests in the year following diagnosis, and if both are normal, yearly thereafter. Nationally,     only 25% of women meet this recommendation. The mean annual Pap testing rate for federally     funded HIV centers is only 55.7%. In 2009, quality improvement statistics from the Johns     Hopkins Hospital Moore Clinic, a large urban HIV center, revealed an annual Pap testing rate     of 59%. This occurred despite interventions to address adherence issues were implemented,     including nurse case management, co-location of HIV and gynecology services, flexible     scheduling, and continuity of care. Women keep their appointments for HIV primary care more     often than for gynecology care in the Moore Clinic, so an intervention that takes place     during a primary care visit could improve cervical cancer screening rates.      The availability of HPV testing provides a unique opportunity to increase perceived     susceptibility to and severity of cervical cancer among women with HIV, and to encourage     follow-up Pap testing. HPV testing involves analyzing a sample of cervicovaginal cells for     the presence of high-risk HPV strains. Detection of high-risk strains of the virus indicates     a high risk for high grade CIN and cancer, while a negative HPV test predicts a less than 2%     risk of developing CIN. HPV testing can be easily conducted by women themselves through     self-collection in a primary care visit. Studies of women without HIV who do not have regular     Pap testing have demonstrated that self-collected HPV testing and results counseling     increases the overall screening rate, and women who test positive for HPV have a high rate of     follow-up Pap testing. Self-collected HPV testing and results counseling could be utilized in     the HIV primary care setting to promote Pap testing among women with HIV.   "
110207|NCT01843465|"     According to data from high volume Centres, documentation of entry block with the Achieve     catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to     assess strategies using the Achieve catheter that can improve this performance.   "
110209|NCT01843439|"     We want to examine the effect of multidisciplinary interventions in asthma patients who had     experienced acute exacerbation of asthma.      In our previous observational studies, elderly asthma patients had a some distinct features     such as impairment of cognitive function, deficiency of micronutrient and absence of     caregiver compared with young adult asthmatics.      We wanted to evaluate whether the long-term course of asthma could be modified by intervening     deficienies which were found in elderly patiensts.      So, we designed a interventional study to correct above risk factors in elderly asthma     patients, which could be aggravating their asthma. Followings are our specific     multidiciplinary items that we want to correct.        1. popularize and educate the asthma action plan        2. run a emergency call system for acute exacerbation        3. educate the proper techniques using inhalers        4. correct the deficiency of magnesium (magnesium 500 mg per day)      After 1 years, we will measure the numbers of acute exacerbations, lung function including     FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study     patients.   "
110210|NCT01843426|"     The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of     patients after a computed tomography (CT) scan. The results of this study will help to     determine the minimum volume of contrast material that can be used to ensure patient safety     while not compromising diagnostic image quality in high-risk patients.   "
110211|NCT01843413|"     This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery     and to see how well it works in treating patients with large brain metastases. Radiosurgery     can send x-rays directly to the tumor and cause less damage to normal tissue.   "
110212|NCT01843400|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Regorafenib for colorectal     cancer.      The objective of this study is to assess safety and effectiveness of Regorafenib using in     real clinical practice.      A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational     period. At 12 months after the first administration of Regorafenib for confirmation of     efficacy information including treatment duration and survival status of the patient.   "
110213|NCT01843387|"     The study investigates the safety, tolerability and efficacy of a single intravenous infusion     of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic     nephropathy and type 2 diabetes.   "
110214|NCT01843374|"     This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with     unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio     to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at     study centers in multiple countries. The study consists of a screening period, a treatment     period, a 90-day follow-up period for safety, and a long-term survival follow-up period.   "
110215|NCT01843361|"     The aim of this study was to determine the prevalence rate and risk factors for chemical     laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.   "
110216|NCT01843348|"     This study was designed to evaluate the renal function comparing Certican based     immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a     standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant     recipients.   "
110217|NCT01843335|"     X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular     aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate     information about endoleak after EVAR. Benefits of CEUS over CT include less radiation     exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent     application and decrease in the cost of EVAR follow-up. This study is designed to investigate     if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to     gain experience with the technique and to introduce CEUS as an alternative for detection of     endoleak in this hospital.   "
110218|NCT01843322|"     The study is aimed at investigating whether repair of endoleak type II can be improved by     adding navigation technology. Can this technology increase precision by guiding the needle     that punctures through the skin as used during the repair procedure? Can the procedure     logistics be improved by using navigation technology instead of computed tomography (CT)     guidance of the needle puncture? Parameters logged during the procedure:        -  was the needle placement successful?        -  number of needle punctures?        -  time used on guidance procedure        -  X-ray exposure dose   "
110219|NCT01843309|"     Purpose Invasive fungal infections cause significant morbidity and mortality in     immunocompromised patients.      Amphotericin B deoxycholate (AmB) is a polyene antifungal agent. The broad spectrum of     activity contributed to it being considered the gold standard of antifungal therapy despite     being associated with high incidences of infusion related adverse events.      AmB exerts their antifungal effect binding to ergosterol; a sterol similar to cholesterol     found in fungal cell membranes. However AmB also binds to cholesterol molecules in mammalian     cell membranes forming intramembranous pores and vacuoles in the distal convoluted tubule of     the kidney producing its nephrotoxic effects.      Nephrotoxicity is the major adverse effect of AmB, often limiting administrations of full     dosage; it's manifested as acute kidney injury, impaired renal concentrating ability,     augmented urinary potassium secretion through tubular Na+/K+ ATPase, type-1 renal tubular     acidosis, which increases the elimination of potassium, and magnesium wasting. Furthermore     potassium depletion potentiates the tubular toxicity of AmB.      The management of potassium wasting may be difficult, even high intravenous doses of     potassium chloride may not be fully effective in correcting the hypokalemia. It has been     probed the use of potassium-sparing diuretics to limit electrolyte wasting in patients     treated with AmB.      In 1988 Smith et al, demonstrated that amiloride was well tolerated and provided effective     control of plasma potassium in patients treated with AmB. This finding was confirmed in 2001     by Bearden et al. However in our country the only available commercial presentation of     amiloride also contains hydrochlorothiazide, limiting its use in such patients.      Spironolactone acts on the distal renal tubule by competitive inhibition of aldosterone,     thereby blocking the exchange between sodium and both potassium and hydrogen in the distal     tubules and collecting ducts. These agents produce a sodium diuresis which results in     potassium retention. There is only one clinical trial by Ural et al, using spironolactone to     prevent hypokalemia in twenty-six neutropenic patients on AmB treatment; they demonstrated     that those patients receiving concomitant AmB and spironolactone (100mg bid) had     significantly higher plasma potassium levels than those receiving AmB alone (P=0.0027) and     required significantly less potassium supplementation to maintain their plasma potassium     within the normal range (P=0.022).      Renal vasoconstriction appears to play a major role in AmB induced reduction in GFR;     recurrent ischemia may lead to structural and tubular damage and permanent nephrotoxic     effects.      Aldosterone modulates the tone of the renal vasculature. Bobadilla et al have shown in animal     models of cytotoxic damage using cyclosporine; that a mineralocorticoid receptor blockade     with spironolactone reduces the structural renal damage, and also prevents renal dysfunction     due to afferent and efferent vasoconstrictions. This group has also shown that prophylactic     treatment with spironolactone completely prevents renal dysfunction and histological signs of     tubular injury from ischemia-reperfusion injuries. And also has demonstrated the ability of     spironolactone in animal models to protect the kidney after establishing an ischemic insult,     when spironolactone was administrated immediately or 3h after the renal ischemic insult had     occurred, reducing levels of sensitive biomarkers such as Kim-1 and Hsp70.      The investigators' hypothesis is that administration of spironolactone in patients treated     with AmB will help to maintain significantly higher plasma potassium levels and will help to     reduce potassium and magnesium supplementation. Moreover spironolactone will help to reduce     the urinary excretion of potassium.      The investigators propose a randomized, double blind, placebo controlled trial approved by     the local ethical committee, to compare the efficacy and security of spironolactone to reduce     electrolytic derangements in three groups: AmB and placebo, AmB and spironolactone 100mg once     a day, AmB and spironolactone 100mg twice a day. The investigators will include 12 patients     per group. Researchers will collect daily plasma creatinine, sodium, potassium, BUN and     urinary potassium, as well as the values of potassium and magnesium supplements administered     orally or parenterally. The researchers will also collect by 7 days urinary levels of NGAL,     KIM-1 and Hsp-70 as tubular injury markers.   "
110221|NCT01843283|"     The purpose of this pilot study is to evaluate the feasibility of and satisfaction with the     revised DEMA and to estimate effect sizes for DEMA through incorporation of a comparison     group. Specific aims are as follows:      Aim 1: Evaluate feasibility of the study for MCI patient/caregivers. Aim 2: Estimate effect     sizes for DEMA on MCI patient and caregiver outcomes. Aim 3: Evaluate MCI patients and family     caregivers' satisfaction with and perceptions of DEMA or IS.   "
110222|NCT01843270|"     The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It     achieves a reliable airway with a low incidence of major complications and     pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the proper     size selection by actual body weight. It was recommended a size 3 for 30-70kg, a size 4 for     70-90 kg, and size 5 for > 90 kg. Obesity increases the fat tissue around an upper airway and     decreases the pharyngeal cross sectional area. Also it was reported that pharyngeal area was     reduced according to the increasing of BMI. Therefore, the aim of this study is to determine     which of actual body weight or ideal body weight is proper on the size selection of laryngeal     mask airway.   "
110223|NCT01843257|"     The investigators wish to study the effects of three forms of bariatric surgery: gastric     bypass, sleeve gastrectomy, and lap banding. The surgery is not part of the clinical trial.     If insurance does not cover the procedure, then the patient is responsible for payment of the     surgical process. The investigators are doing pre- and post-surgery testing to provide a     better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol     absorption, distribution and elimination from the body; 2) the effects of alcohol on blood     sugar; and 3) the effects of alcohol on mood.   "
110224|NCT01843244|"     Data from both the traditional invasive cardiac monitors and the Nonin will be collected     simultaneously. The investigators will analyze Nonin data for peak and trough variation with     respiration, area under the curve, time from trough to peak, and slope, and compare these to     data collected from the invasive monitors to look for correlations in clinically important     parameters such as blood pressure, central venous pressure, cardiac output, etc.   "
110225|NCT01843231|"     This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the     safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight     loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss     [TBWL] in Treatment subjects versus that of Control subjects at 12 months is the primary     endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group     is a co-primary endpoint.   "
110226|NCT01843218|"     Erectile dysfunction will be explored by recording R / P and self-administered questionnaire     IIEF-5.   "
110227|NCT01843205|"     Methamphetamine use disorders are an unrelenting public health concern. Intensive research     efforts have yielded behavioral interventions that reduce methamphetamine use, however, these     interventions are not universally effective and treatment effects diminish over time.     Development of a pharmacotherapy that enhances the efficacy of these interventions is a     priority for the National Institute on Drug Abuse. This study proposes to determine the     impact of buspirone maintenance on self-administration of methamphetamine. These preliminary     data will be used to support further research developing buspirone as a pharmacotherapy for     methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate     the reinforcing effects of methamphetamine.   "
110228|NCT01843192|"     This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS)     for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers     45 mm and/or 60 mm (study devices).   "
110229|NCT01843179|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug to learn whether the drug is effective in treating a     specific cancer. Investigational means that sulindac is still being studied and that     research doctors are trying to find out more about it. It also means that the FDA has not yet     approved the use of sulindac for your type of cancer.      Participants in this study must have undergone previous chemotherapy and achieved complete     remission, which is the absence of disease activity in people with a chronic illness, in this     case AML. Unfortunately, a significant number of patients with AML who achieve a complete     remission with initial chemotherapy eventually experience a relapse, often within a few     months.      Previous research studies have demonstrated that a type of medication frequently used to     treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX     inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX     inhibitors are ibuprofen and naproxen.      For this study, the investigators are using a COX inhibitor called sulindac, which has been     FDA approved and used to treat pain and inflammation for many years, and has also been     studied in suppressing certain tumors of the gastrointestinal system. The main goal of this     study is to determine whether sulindac can help participants remain in a state of complete     remission following the initial course of chemotherapy for AML, and two cycles of     chemotherapy that is standard of care for your cancer, called consolidation chemotherapy.     During the course of this study, the investigators will also attempt to learn more about how     COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by     studying the participants on this trial.   "
110230|NCT01843166|"     Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal     estrogen cream treatment with the pessary will be randomized amongst the patients and patient     satisfaction and complication rates will be assessed during follow-up.   "
110231|NCT01843153|"     The role of a sciatic block in addition to a femoral block remains controversial. The study     addresses this topic by comparing a continuous block versus an injection on demand.   "
110232|NCT01843140|"     The FIRST project is a national fertility preservation registry for young women facing cancer     treatments. The investigators will examine how different cancers and treatments affect the     reproductive health of young survivors. This prospective cohort study seeks to recruit young     women close to time of cancer diagnosis and treatment. Participants will answer a yearly     questionnaire on their current health. A subset of participants will provide dried blood     spots to measure reproductive hormones. The primary goal of the study is to determine the     risk of infertility and time to pregnancy in young female cancer survivors.   "
110233|NCT01843127|"     To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes     mellitus (T2DM).   "
110281|NCT01842503|"     Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics     (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate     whether GET 73, as compared to placebo, results in diminished cue-reactivity responses to     alcohol cues in terms of urge to drink during the cue reactivity session and results in lower     quantity of alcohol consumed during an alcohol self-administration session.   "
122733|NCT01679496|"     The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory     markers after intake of food items with different fatty acid composition.   "
110234|NCT01843114|"     The prevalence of diabetes and diabetes-associated complications is still increasing. Several     major long-term complications of diabetes such as cardiovascular disease, chronic renal     failure, diabetic retinopathy and others relate to the damage of blood vessels. Given that     the eye provides the unique possibility in the human body to directly visualize blood     vessels, much interest has been directed towards studying the ocular circulation. Although     data of large epidemiological studies indicate that changes in retinal vessel caliber reflect     other diabetes related factors, such as fasting glucose levels, there is still conflicting     evidence on blood flow alterations in patients with diabetes. This is also related to the     fact that up to now, methodological difficulties aggravate the assessment of blood flow     changes in the retina in larger groups of patients. In the present study we propose to     overcome this problem by using a technique called bi-directional Fourier Domain Doppler     Optical Coherence Tomography (FDOCT), which we have developed in the recent years to measure     retinal blood velocities. This technique allows for the non-invasive investigation of blood     flow changes in human retina and will help us to better understand diabetes related vascular     changes. The present study will use this technique to assess retinal blood flow changes in     patients with diabetes and healthy subjects.   "
110235|NCT01843101|"     The aim of the present study is to develop a protocol for optimal corneal 3-dimensional     imaging based on measurements in healthy volunteers. For this purpose, a customized     ultra-high resolution Spectral Domain OCT will be used. To validate whether the protocol can     also be applied in patients with corneal pathologies, for whom it is intended to be used,     measurements in these patients will be performed. We propose to obtain images from patients     with keratoconus, since this is one of the most frequent causes for corneal transplantations     in Europe and from patients with corneal neovascularization which is a major cause of vision     loss in several ophthalmic diseases. Based on the obtained measurement protocol, further     studies investigating the pathophysiology or treatment success of several corneal pathologies     can be planned.   "
110297|NCT01842295|"     The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding,     bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological     parameters, lifestyle, quality of life) involved in fertility of obese adult men.   "
110236|NCT01843088|"     Mannitol cream has been shown clinically to be effective for pain control. To determine if     this effect is worth testing on a larger scale, 170 runners will receive a sample of 25%     mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg     following a 10 km or longer run, and for the following five days. Mannitol and control legs     will be chosen at random for each runner. Pain scores before and after cream application will     be acquired each day for each leg. Means and standard deviations found will be used to     determine the size of a larger study.   "
110237|NCT01843075|"     This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in     patients with mild Alzheimer's dementia (AD). The investigators aim to recruit patients with     mild Alzheimer's dementia as defined by the National Institute of Neurological and     Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association     (NINCDS-ADRDA) Criteria for Probable Alzheimer's Dementia or meeting Dubois criteria for     early AD, with Mini Mental State Evaluation score of at least 20 out of a maximum of 30 and a     CDR Global score of 0.5 or 1.      Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.   "
110238|NCT01843062|"     The study is designed to evaluate the clinical efficacy, safety and tolerability of     selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.   "
110239|NCT01843049|"     Most local failures after definitive chemoradiation for unresectable esophageal cancer occur     in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located     in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose     boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost     (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the     esophageal GTV defined prior to treatment may improve local tumor control.   "
110240|NCT01843036|"     The aim of this randomized controlled trial (RCT) is to conduct a second, independent     evaluation the implementation and impact of the Durham Connects (DC) brief universal nurse     home-visiting program to prevent child maltreatment and improve child and family health and     well-being. Durham Connects is the first home-visiting program that is designed to prevent     child maltreatment and improve health and well-being outcomes in an entire community     population.      Program evaluation will test four hypotheses: 1) The program can be implemented with     population reach, fidelity to the manualized intervention protocol, and reliability in     assessment of family risk; 2) Random assignment to the Durham Connects program will be     associated with lower rates of child maltreatment and emergency department     maltreatment-related injuries, better pediatric care, better parental functioning, and better     child well-being than assignment as control; 2) Intervention effect sizes will be larger for     higher-risk groups; and 3) Community resource use and enhanced family functioning will     mediate the positive impact of Durham Connects on outcomes.   "
110241|NCT01843023|"     The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old     opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual     (TAU).   "
110242|NCT01843010|"     This prospective, double blind, placebo-controlled, parallel group study will be conducted in     the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged     18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia     will be involved in this study. According to previous studies and our pilot trial, estimated     120 patients will be involved in this study. All eligible patients will be randomly assigned     to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before     intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive     normal saline at the same time points. The shoulder pressure pain thresholds will be measured     with a pressure algometer by an independent doctor blinding to medication and grouping at the     day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and     side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At     the end of the observation, the intensity of the maximal shoulder pain will be assessed.   "
122734|NCT01679483|"     To compare the incidence of lymphocele and lymphatic ascites between patient who use versus     who do not use FloSeal during lymph node dissection   "
110243|NCT01842997|"     Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in     population in China. However, there was little epidemiological evidence of safety when     vaccinated in healthy pregnant women. The main objective of this study is to assess the     safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy     pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women.     And participants were included up to 226 healthy pregnant women aged 18 -35 years old who     have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The     pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups:     vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were     administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no     vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And     observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated;     and protective effect was observed for six months.   "
110244|NCT01842984|"     The purposes of this study are: (1) decrease loneliness and social isolation and increase     social competence and social integration of older adults experiencing loneliness; (2) examine     an intervention process grounded in a theoretical model that was developed in a previous     study. The intervention process is tailored to the participants' barriers and abilities, and     includes up to 10 personal meetings with an activities counselor and several group meetings.   "
110245|NCT01842971|"     The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients     with liver metastasis from colorectal cancer.   "
110246|NCT01842958|"     The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone     Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC     SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery     and 12 months post-implant placement. The secondary objectives will assess differences in     clinical outcomes between the test and control implants, including implant success and     survival, gingival recession, subject satisfaction and additional early bone level     measurements.   "
110312|NCT01842087|"     A single blind, six week dietary intervention will be conducted in order to evaluate the     impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life     in patients presenting with a moderate to severe decline in kidney function.   "
110247|NCT01842945|"     The aim of this study is to examine the effects of cognitive behavior therapy (CBT) for     procrastination, and to investigate whether it can be delivered via the Internet. Two     treatment groups will be used, one with therapist contact and one without, as well as a     wait-list control group. It is assumed that the treatment group with therapist contact will     be superior to the treatment group receiving no therapist contact since procrastination can     be partially explained as a self-regulatory failure. Both treatment groups are presumed to be     superior to the wait-list control.   "
110248|NCT01842932|"     Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind     controlled trial   "
110249|NCT01842919|"     In this project investigators will evaluate the benefits of contemporary dance training using     a comprehensive test battery combining standard neuropsychological batteries, psychological     questionnaires on emotion, empathy and quality of life, structural magnet-resonance     tomography (MRI), as well as psychophysical tests on movement recognition and agency, the     sense of being in control of one's own movement.      For 10 years now two experienced dancer‐choreographers lead dance workshops for people with     Huntington's Disease (HD) and their family and caregivers in Paris. This project will     evaluate objectively the effects these workshops have, by assessing a new group of 18     patients and their partners and caregivers before and after 8 month of weekly dance training.      People with HD are troubled by involuntary movements, of which they are however not     accurately aware, but moreover they become impaired at recognising instrumental actions in     others. It is well known that observing somebody else's action and executing the same action     rest on a common neural network. This might mean that improving one's own action execution     can improve the observation and understanding of others' actions in turn. Here, investigators     will investigate both the impact the movement impairments caused by HD might have on patients     themselves as well as on their partners and caregivers, as a consequence of the fact that own     and other action representations are shared. After 8 months of contemporary dance training,     both groups will be tested again, in order to establish if both action execution (self) and     perception (in others) have improved.      Other recent psychophysics and brain imaging experiments have demonstrated how the sense of     agency is composed from external cues (for example sound) of the consequences of movements,     and from internal sensorimotor information that result from the action plan. Importantly, in     HD the latter input might be impaired, but this has never been systematically tested. Making     use of a psychophysics paradigm disentangling the two cues to agency investigators first     monitor the sense of their own movement in HD, and further assess the changes in agency and     in the role of these cues to agency after eight months of contemporary dance practice.      Finally investigators will monitor the structural brain changes accompanying this progress,     comparing the brain before and after regular dance practice and correlating action     recognition psychophysics measures of agency with these changes.      In sum, this project has a double impact. Firstly it will scientifically evaluate the impact     of dance on the normal but especially the brain affected by a neurodegenerative disease that     causes movement impairments, and establish its effect on behaviour and wellbeing. Secondly it     will evaluate in patient partners and caregivers how they represent the patients' as well as     their own movements and how this changes with dance practice.   "
110250|NCT01842906|"     The study is examining if an over-the-counter device (Theravent) worn while sleeping can     reduce acute mountain sickness upon awakening in a high altitude trekking population.   "
110251|NCT01842893|"     The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when     used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.   "
110252|NCT01842880|"     The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas     Disease prognosis. This analysis will be done through the correlation between the plasmatic     levels of this molecule with functional and laboratory tests.   "
110253|NCT01842867|"     The purpose of this study is to analyze the efficacy of syndecan-4 as a biomarker on the     Chagas Disease prognosis. This analysis will be done through the correlation between the     plasmatic levels of this molecule with functional and laboratory tests.   "
110254|NCT01842854|"     The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker on the     Chagas Disease prognosis. This analysis will be done through the correlation between the     plasmatic levels of this molecule with functional and laboratory tests.   "
110282|NCT01842490|"     No serum biomarker has qualified for clinical use until now. However several biomarkers,     especially markers of inflammatory or proteolytic activity seem to promising in the     identification of vulnerable plaques. Moreover, recent study confirmed that contrast-enhanced     ultrasound imaging(CEUS) can visualize intraplaque neovascularization and represent the     plaque vulnerability. In this study we try to identify indicators through analysis of the     relationship between plaque neovascularization seen by CEUS and well known biomarkers such as     serum matrix metalloproteinase(MMP)-2, MMP-9, cathepsin family(L,S,V), cystatin C,     lipoprotein phospholipase A2, and hs-crp   "
138127|NCT01475760|"     The purpose of this study is to determine the efficacy of chitosan chewing gum (K2CG) in     reducing serum phosphorus in subjects with chronic kidney disease.   "
110255|NCT01842841|"     Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB)     that leads to progressive accumulation of glucocerebroside within macrophages and subsequent     tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1     Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1     Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher     disease present with acute neurological deterioration, which leads to early death. Those with     Type 3 disease typically display a more sub-acute neurological course, with later onset and     slower progression.      The primary objective of this study is to evaluate the long-term safety of every other week     (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed     study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa.      Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type     1 Gaucher disease.   "
110256|NCT01842828|"     Currently available smoking cessation treatments help only about 15% of smokers to quit     long-term. These treatments do not typically address the behaviours and sensations associated     with the act of smoking (e.g. handling a cigarette, inhaling, taste and feel of smoke on the     throat). There is evidence that these elements influence smoking behaviour and cessation.     Electronic cigarettes (EC) are a new product with a strong potential to be a realistic     behavioural replacement for smoking.      Whilst EC deliver nicotine, their use does not involve tobacco combustion, which is the     primary source of the many thousands of dangerous chemicals to which smokers of conventional     cigarettes are exposed. Studies on EC products and users indicate there is little doubt that     they are substantially safer than conventional cigarettes.      The investigators plan to conduct a study one of the very first studies to test the effects     of adding EC to standard care on long-term validated outcomes. Before launching such a large     and demanding trial however, data are needed on what proportion of smokers would be     interested in using EC and what compliance with EC use can be expected, and no data exist to     inform how large a sample is needed. This pilot study would provide such data.      A total of 220 smokers would be recruited at smoking cessation clinics in London (n=20),     Madrid (n=100), and Prague (n=100). Within each site, half the smokers would be randomised to     receive standard smoking cessation behavioural support and medication (standard care; SC),     and half to receive SC plus EC. The EC group would receive a four week supply of EC. The     outcome measures for the study would be smoking status at 4 and 24 weeks after the target     quit date, EC use, acceptability, and adverse events.   "
110257|NCT01842815|"     The purpose of this study is to collect further data on the safety and efficacy of removing     unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.   "
110258|NCT01842802|"     The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser     to reduce the volume of fat.   "
110259|NCT01842789|"     The purpose of this study is to test both user preference and speed of targeting with the use     of the Acessa System with Targeting Animation Guidance (TAG).   "
110260|NCT01842776|"     The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis     patients. It is a quality improvement project that consistent of 4 tracks. Tracks 1 & 2:     Implement use of checklists of activities for staff to complete when patients are admitted to     the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition     management, patient coaching, and communication between institutions. Track 3: Work with     physicians to develop process to individualize post-hospitalization dialysis orders and     improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to     follow patients in the hospital and 30 days post-hospitalization to facilitate care and     patient coaching.   "
110261|NCT01842763|"     The purpose of this non interventional research is to set up a French database, initially for     3 years, of patients suffering from refractory chronic headache disorders (chronic migraine,     cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua,     cervicogenic headache disorders), and treated by occipital nerves stimulation.      Every team using this neuromodulation approach in France is likely to participate in the     network.      Fifty patients a year are expected. They will be informed about data which are collected and     why they are collected.      The data will come from medical files and questionnaires filling out by the patients. The     data will be collected on a case report form adapted to each refractory chronic headache     disorder. The case report form pages will be faxed to the coordinating team who will enter     the data in the database and analyse the data in a descriptive manner.      These data are social and demographic data, medical data (headache features, headache     functional and emotional impact, medications, and concomitant medical conditions), technical     data (kind of electrodes and implantable pulse generator used, stimulation parameters     chosen), and safety data.      This research should provide an update on practices, an evaluation of the efficacy and long     term safety of occipital nerves stimulation, and perhaps help in identifying response     predictive factors to this neuromodulation approach.   "
110262|NCT01842750|"     This study aims to test the hypothesis that insertion of an endorectal balloon into a patient     receiving radical prostate radiotherapy by treatment radiographers is feasible without the     patient experiencing undue discomfort. In addition this study will test the hypotheses that     insertion of the rectal balloon prior to radiotherapy delivery stabilises rectal volume     during radiotherapy treatment and minimises organ motion within the pelvis.   "
110263|NCT01842737|"     The Patient Response to Graded Sensory Stimulation-Pilot Study (PRoGReSS-PS) will measure     back pain perceptions in participants who receive either chiropractic treatment or foot     massage. The study will also measure back pain and function with research questionnaires and     other measures.   "
110264|NCT01842724|"     The purpose of this study is to determine the difference in the results between Motec and     Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.   "
110265|NCT01842711|"     A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical     agent or agents have the potential to cause contact irritation or contact allergy in the     skin. Allergy is only elicited in immunologically competent individuals who have become     sensitized through exposure to the chemical agent at a sufficient concentration and for a     sufficient duration of time.   "
110898|NCT01834391|"     The purpose of this study is to see if the investigators can identify early those patients     who are admitted to the hospital and have a urinary tract infection (UTI) or those patients     that develop a UTI during their hospitalization.   "
110266|NCT01842698|"     Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary     surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain.     Control of the pain is essential in the perioperative management.      Nowadays, there are several strategies to support this pain, including regional anesthesia     techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and     respiratory complications significantly. ParaVertebral Block (PVB) is a technique as     effective as epidural analgesia in the treatment of pain after thoracotomy and could present     a more limited number of complications. However, there is no consensus on the best technique     for realisation of PVB.      Para-vertebral catheterisation can be performed by posterior approach in seeking a strength     loss after bone contact of transverse vertebral process using the technique of Eason and     Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of     all puncture invasive actions, is an effective contribution to the realisation of a BPV, but     still insufficiently validated. First used to measure the distance skin - posterior     costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography     has recently led to the publication of echo-guided techniques combining recognition of     structures defining the space para- vertebral, viewing the progression of the needle and the     spread of the local anesthetic. The handling of the ultrasonographic probe associated with     the puncture requires additional learning.      The objective of this project is to study the feasibility of para-vertebral catheter     insertion under ultrasonographic control. The appearance like pigtail of the catheter, the     most recently proposed, seems the more attractive in terms of safety. The aim of this pilot     prospective study is accurately quantify all qualitative parameters related to the technique     in order to achieve a future validation with a medico-economic component.      Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to     medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.      This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary     resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required     is 60 patients over a period of inclusion of 12 months.   "
110267|NCT01842685|"     In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention     (BTD) in patients with overactive bladder syndrome who failed previous treatment of     anticholinergic drugs.      The investigators' hypothesis is that it will improve the storage symptoms.   "
110268|NCT01842672|"     The combination of mitoxantrone and clofarabine as reinduction therapy will be safe, well     tolerated and effective in children, adolescents and young adults with poor risk     refractory/relapsed acute leukemia and high grade non-Hodgkin lymphoma (NHL).   "
110269|NCT01842659|"     Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region     lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a     mosaic pattern, rendering their detection difficult, especially given the scarcity of     available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND)     for imprinting abnormalities of the 11p15 region is not available.      The recent development of a quantitative PCR method that permits the methylation index (MI)     of imprinted regions to be calculated renders PND technically possible. Nevertheless, because     of the mosaic nature of these anomalies, it is essential to verify that the methylation     pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the     blood.   "
110270|NCT01842646|"     This study is being done to see how safe an investigational drug is and test how well it will     work to help people with refractory/relapsed myelodysplastic syndrome (MDS) or chronic     myelomonocytic leukemia (CMML).   "
110271|NCT01842633|"     The purpose of this multi-center study is to assess the efficacy of headache relief of new     paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type     headache (ETTH).   "
110272|NCT01842620|"     This is an open-label, single-center, randomized, 2-way crossover study to evaluate the     bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference     product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult     subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period     1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two     500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following a     washout of at least 7 days, subjects will be crossed over in Period 2 to receive the     treatment that they did not receive in Period 1.   "
110273|NCT01842607|"     This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab     administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care     in subjects who have severe, refractory asthma and a history of eosinophilic inflammation.     Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to     consent for this study.   "
110274|NCT01842594|"     Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and     sirolimus.   "
110275|NCT01842581|"     The purpose of the study is to evaluate if Rifaximin alone or Rifaximin plus Lactulose delays     the onset of hepatic encephalopathy (HE) in cirrhotic subjects who have had a previous     episode of HE.   "
110276|NCT01842568|"     Worldwide over 2 million adults (>30,000 Canadians) undergo heart surgery annually. Although     heart surgery provides important survival benefits, it is associated with potential major     complications such as death, stroke, and heart attack. There is promising evidence that     measurement of heart injury markers after surgery will identify patients at risk of death or     major complications.      This study will determine the current incidence of major complications in a representative     sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current     burden of complications will inform clinicians, administrators, government and granting     agencies about resources required to address the problem. This study will also establish the     role of measuring heart injury markers to identify important heart injury after heart surgery     and the proportion that would go undetected without routine heart injury marker monitoring.     This information will facilitate further studies of timely interventions. In summary, the     VISION Cardiac Surgery Study addresses fundamental questions that will have profound public     health implications given the millions of adults worldwide who undergo heart surgery     annually.   "
110277|NCT01842555|"     The data elements for the PDT Registry project include virtually all the elements in the     standard hospital-based cancer registry record, although in some cases at a finer level of     detail. All data points should be found in the participant's medical record. The principal     difference between the PDT Registry data set and that collected by the registries is the     inclusion of more information specific to PDT.   "
110278|NCT01842542|"     The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS     therapy in women who have postpartum depression.   "
110279|NCT01842529|"     The aim of this prospective randomized double-blind study was to compare the efficacy and     safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in     early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial     fibrillation undergoing coronary artery bypass graft (CABG) surgery.   "
110283|NCT01842477|"     Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal     tissue. In Europe, about one million patients encounter a surgical bone reconstruction     annually and the numbers are increasing due to our ageing population. Bone grafting intends     to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage,     but this is only attained presently by including cells capable of forming bone into the     augmentation.      Bone autograft is the safest and most effective grafting procedure, since it contains     patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance     osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction).     However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from     the iliac crest) represents an additional surgical intervention, with frequent consequent     pain and complications.      We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically     implanted with synthetic bone substitutes contribute to the resolution of the health and     socioeconomic complications of delayed union or non-union after diaphyseal and     metaphyseal-diaphyseal fractures with safety and efficacy.   "
110284|NCT01842464|"     Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here     to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.   "
110285|NCT01842451|"     A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of     VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C   "
110931|NCT01833962|"     The purpose of this study is to assess fusion status in patients who underwent spinal fusion     with Actifuse synthetic bone graft versus other bone graft material (including autograft) in     achieving lumbar spinal fusion.   "
110286|NCT01842438|"     Even with careful prostate surgery, men find it difficult to have an erection. Our previous     research shows that couples are not often supported to cope with the effects of surgery on     their sexual relationships. In this study, the investigators will design a way of supporting     couples, and test how well it works.      The investigators will decide what the support should include (e.g. duration, frequency and     timing of the support). The investigators will do this by looking at available literature on     the subject.      The investigators will recruit 68 couples to the study, half will receive standard care and     the other half will be invited to attend six sessions of psychosexual support with specially     trained professionals (trained by men affected by prostate conditions and a cancer/couple     support specialist). Before and after the support, men and their partners will be asked to     complete questionnaires which measure quality-of-life, emotional needs, and their     relationship. The investigators will ask the couples to fill out the questionnaires again     six-months later to see if the support has long-term benefits. At the end of the study the     investigators will also interview 10 couples to find out their views of the support, and     another 10 couples about standard treatment.      When the investigators have tested this support, they expect to see men and their partners     tell us that their quality of life has improved, and they have higher satisfaction with their     relationship. The investigators will calculate the overall cost of providing this support,     and the benefits it has on reducing the need for other health-care services (like General     Practice use).   "
110287|NCT01842425|"     The purpose of this study is to determine what changes occur in body- and liver-composition     during four weeks of low calorie diet in morbidly obese females   "
110288|NCT01842412|"     The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes     in mitochondrial function in claudication. Final purpose is to determine the optimal exercise     frequency in treatment of claudication.   "
110289|NCT01842399|"     Background:      - Resveratrol is a compound found in the skin of red grapes. It is being tested to see if it     can have positive effects on human health. Lab studies show that it may help lower blood     sugar, improve heart and blood vessel health, and prevent cancer. Researchers want to test     different dose levels of Resveratrol to see what kind of effects it has on older overweight     people. It will be tested in healthy volunteers at least 50 years of age.      Objectives:      - To test the effects of different dose levels of Resveratrol on heart and blood vessel     health.      Eligibility:      - Healthy overweight nonsmoking volunteers at least 50 years of age.      Design:        -  This study will involve a screening visit and four study visits. Some of the study          visits will involve overnight inpatient stays.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. They will be given a list of foods that they should avoid          eating while on the study.        -  Participants will be separated into three groups. Two groups will take different dose          levels of the study drug. The third group will take a placebo.        -  At the first study visit, participants will stay in the clinical center overnight for 2          days of tests. They will provide blood and urine samples and have body scans to measure          fat and muscle mass. They will also have exercise tests. A muscle biopsy will also be          performed. At this visit, they will receive their dose of the study drug. They will          continue to take this dose for as long as they are on the study.        -  The second visit will be 16 weeks after the first one. It will take only 2 hours, and          repeat most of the tests from the screening visit.        -  The third visit will be 16 weeks later. It will involve an overnight stay. Most of the          tests from the second visit will be repeated.        -  The fourth and final visit will be 16 weeks later. It will involve an overnight stay.          Most of the tests from the initial study visit (including the scans and the exercise          tests) will be repeated.   "
110290|NCT01842386|"     Background:        -  Healthy people have white blood cells that protect them against bacteria, viruses, and          fungi. However, some people have diseases which cause the body to make white blood cells          that do not work properly. These white blood cells can attack the body s own proteins.          These types of diseases are called anti-cytokine autoantibody-associated diseases. They          can cause severe illnesses and even death. They are also difficult to treat with          standard drugs.        -  Rituximab is a drug used to treat rheumatoid arthritis. It attacks white blood cells          that do not work properly. Currently, it is not approved for treating anti-cytokine          autoantibody-associated diseases. However, researchers think that it may be able to help          treat people with these immune diseases.      Objectives:      - To see if rituximab is a safe and effective treatment for anti-cytokine     autoantibody-associated diseases.      Eligibility:        -  Individuals at least 18 years of age who have anti-cytokine autoantibody-associated          diseases.        -  Participants must also be enrolled in a related immune disorder study at the National          Institutes of Health.      Design:        -  The study will last 24 months. Participants will take rituximab for 6 months and have          follow-up visits for the remaining 18 months.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Other samples will be collected as needed if participants          currently have an infection.        -  Participants will enter the hospital for 1 week at the start of treatment. They will          have four doses of rituximab given 2 days apart. This first treatment will be monitored          with frequent blood tests.        -  Over the next 6 months, participants will have four more doses of rituximab given about          1 month apart. Treatment will be monitored with frequent blood tests and sample          collections as needed.        -  There will be four follow-up study visits at 3, 6, 12, and 18 months after the last dose          of rituximab.   "
110291|NCT01842373|"     The purpose of this research study is to test which topical anesthesia: LMX4 (Lidocaine 4%)     or BLT (Benzocaine 20%, Lidocaine 6%, and Tetracaine 4%) is more effective in reducing     discomfort during treatment with the Fraxel DUAL 1550/1927 (Solta Medical, Hayward, CA). No     studies have been done on the effectiveness of LMX4 versus BLT using the Fraxel DUAL,     although individually LMX4, BLT, and the Fraxel DUAL have been studied extensively.      The hypothesis is that there will be no clinical difference between the two topical     anesthetics.   "
110292|NCT01842360|"     The purpose of the study is to evaluate the efficacy and safety of a biological vaccine     (MV130 in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with a placebo     group.   "
110293|NCT01842347|"     The purpose of this study is to treat children with severe, moderate, resistant or relapsing     C. difficile infection and to determine the changes in the intestinal microbiome (all of the     bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data     will be collected throughout the FMT procedure to determine effectiveness and to help     standardize this procedure. Stool samples will be collected to look at the different bacteria     that are in the intestines before and after FMT.   "
110294|NCT01842334|"     1. Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS) vs.          placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine          replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking          nicotine-dependent outpatients.        2. Compare the relative efficacy of ten weeks of once weekly 250 mg DCS vs. placebo on the          process of extinction and the memory encoding process.   "
110295|NCT01842321|"     The purpose of this study is to estimate antitumour activity of abiraterone acetate in     Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast     Cancer.   "
110296|NCT01842308|"     This phase I/II trial studies the side effects and best dose of carfilzomib when given     together with melphalan and to see how well they work in treating patients with multiple     myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     melphalan, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill     more cancer cells.   "
110298|NCT01842282|"     This study involves the use of a research drug, Amlexanox, for the treatment of type 2     diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD).     Amlexanox is taken orally in a pill three times a day. The investigators plan to continue     therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The     investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol,     liver function, insulin resistance) and body composition characteristics (e.g. the pattern of     fat distribution in the body). Seven eligible subjects in this study will also be evaluated     for a change in liver disease by a liver biopsy.   "
110299|NCT01842269|"     Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept®     Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant     Patients   "
110300|NCT01842256|"     The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the     pharmacokinetic properties of atorvastatin.   "
110301|NCT01842243|"     Despite considerable effort the optimal site to place a pacemaker lead at the time of     pacemaker implant remains unclear. Historically pacemaker leads have always been inserted at     the bottom (apex) of the heart. It is suggested that a lead placed at the apex is associated     with an increase in heart rhythm problems and also heart failure (impaired pumping function).     The top of the ventricle (septum) has been investigated as an alternative site and is now     routinely used by some centres. Previous estimation of the hearts pumping function (ejection     fraction) has been limited to the use of echo (sound waves). Echo is not sensitive enough to     detect small changes in the ejection fraction reliably (measure of pumping function of     heart). The gold standard for measurement of ejection fraction is MRI (using magnets).     Previous pacemakers have not been compatible with MRI scans. The latest generation of     pacemakers are now able to be safely scanned within an MRI scanner. This allows a much more     accurate estimation of the effects of a pacemaker on the ejection fraction which has not yet     been studied.      The investigators plan to study those patients undergoing a pacemaker implant and ablation     procedure as part of their standard care.      Individuals will have an exercise test, blood test used to measure biomarkers and fill in a     symptom questionnaire.      Individuals will have a Cardiac MR compatible pacemaker fitted and 2 ventricular leads will     be inserted, one apically and one septally. Only one lead will be used at any given time.     Individuals will then undergo their planned AV node ablation.      Following this they will have a cardiac MR scan. Further MRI scans will be performed at 9 and     18 month intervals, as will symptom questionnaires, blood tests (BNP) to determine heart     muscle strain, exercise testing and echocardiograms.      The hypothesis is that a lead placed on the septum will produce superior cardiac performance     over the short and long term.   "
110302|NCT01842230|"     The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic     properties of Telmisartan/S-amlodipine   "
110303|NCT01842217|"     Validation of [18F]-FES for imaging of estrogen receptors in the brain      The primary objective of the study is to determine if [18F]-FES Positron Emission Tomography     (PET) can be used to quantify the estrogen receptor expression in the human brain.   "
110304|NCT01842204|"     A monocentric interventional randomized placebo controlled trial evaluating the efficacy of     the post surgical and wound care recovery kit.      It's a small device that consists of a thin metal ring that is placed on the skin surface,     non-invasively. It's connected with a small battery. When the plastic tag is removed and the     button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is     created. It influences the receptor-ligand binding at the cell surface and might improve     wound healing by diminishing wound edema and inflammation. It possibly helps reducing the     inflammatory reaction induced by surgery.      Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at     the time of bandage, a kit will be applied at the level of the incision. One group will at     random receive a working device, the other half will have a kit without active     electromagnetic field.      Postoperative analgesic consumption will be measured in a diary and pain and quality of life     will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.      The aim of this study is to evaluate whether the placement of the device reduces the acute     postoperative pain and whether it reduces the incidence of chronic groin pain.   "
110305|NCT01842191|"     The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum     proinflammatory cytokines levels, oxidative stress markers and disease progression in MS.   "
110306|NCT01842178|"     This study is designed to evaluate the potential benefit in pregnancy rates produced by an     endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated     oocytes.   "
110307|NCT01842165|"     The purpose of this study is to determine if 68Gallium-octreotate and 18Fluorodesoxyglucose     uptake, apparent diffusion coefficient and post 177Lu-octreotate SPECT/CT dosimetry are     reliable predictors for lesion-by-lesion treatment outcome.   "
110447|NCT01840332|"     The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine     treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for     cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks.     Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin     dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks     in majority of patients.   "
110308|NCT01842139|"     This randomized phase I trial studies the side effects and best way to give vaccine therapy     together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete     remission. Vaccines made from the WT1 peptide may help the body build an effective immune     response to kill cancer cells. Montanide ISA 51 VG and poly-ICLC may enhance this response.     Monoclonal antibodies, such as basiliximab, can block cancer growth in different ways. Some     block the ability of cancer to grow and spread. Others find cancer cells and help kill them     or carry cancer-killing substances to them. It is not yet known whether WT1 126-134 peptide     vaccine with Montanide ISA 51 VG is more effective than with poly-ICLC when given together     with basiliximab in treating AML   "
110309|NCT01842126|"     The primary objective of the study is to evaluate the safety and tolerability of a range of     single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a     range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy.     Secondary objectives of this study are to determine the single IV and SC dose     pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of     bioavailability by comparing SC exposure to IV exposure in each participant, to determine the     multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to     assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess     the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar     radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC     administrations in participants with painful lumbar radiculopathy.   "
110310|NCT01842113|"     The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction     with the use of nutritional concepts is effective in improving morbidity and quality of life     in cirrhotic patients suffering from hepatic encephalopathy (HE).   "
110311|NCT01842100|"     Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced     abortion, and at the same time alters women's sexual behavior and prevents further     re-infection by sexually transmitted infections when compared to the universal antibiotic     prophylaxis strategy.   "
110314|NCT01842061|"     The investigators propose a 6-month, parallel, single-blind randomized controlled trial (RCT)     feasibility study of a self-management program to reduce sedentary time and increase physical     activity (Sit Less to Move More) in women aged 55-70 years. The primary aim is to determine     feasibility and acceptability of the intervention; and the secondary aim is to test the     effect of the intervention on the primary health outcome, physical activity (mean daily step     count by accelerometry) at 6 months. The investigators will also conduct an economic     evaluation and a process evaluation to guide a future larger study and to inform a scaled-up     implementation plan.   "
110315|NCT01842048|"     The main goals of deep hyperthermia combined with external beam radiation (EBRT) on bone     metastases are the response on pain relief, duration of response and time to achieve complete     pain relief.   "
110316|NCT01842035|"     The purpose of this study is to determine whether a blunted heart rate response to     regadenoson is an independent predictor of sudden cardiac death.   "
110317|NCT01842022|"     A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and     mood, however, the data in older adults and those most prone to cognitive dysfunction, is     limited and conflicting. One explanation is that the GL of a meal may interact with a     person's pre-existing glucose tolerance (GT).      As older adults have a higher incidence of glucose tolerance and are more likely to     experience memory problems the present study considers the interaction between the GL of meal     in those with better or poorer GT.      The population studied will not have a history of diabetes or dementia. A battery of     cognitive tests will be administered after meals sweetened with one of three sugars known to     vary in the rate that they release glucose into the blood stream.   "
110318|NCT01842009|"     The purpose of this study is to investigate the mean number of stimulation (high     definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a     clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS)     for pain. These data will be important in defining the optimal number of sessions for future     fibromyalgia subjects in Phase III trials.   "
110319|NCT01841996|"     This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study.      The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics     of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in     adults with distal subungual onychomycosis of the toenails.   "
110320|NCT01841983|"     While most of the research on integrated approaches of occupational health and safety and     worksite health promotion to date has focused on manufacturing settings, employment is     shifting to the service sector. Within this sector, health care employs over 12 million     workers, and is the second fastest growing industry in the U.S. economy. In contrast to     workers in other industries, rates of occupational injuries and illnesses among health care     workers have increased over the past decade. The purpose of this study is to lay the     foundation for integrated interventions in health care through examination of the     associations of worker health outcomes and risks on and off the job with work policies and     practices and to address the prevalent issues of musculoskeletal disorders (MSDs),     particularly low back pain disability (LBPD), and health promotions through physical activity     among patient care workers. The specific aims of this study are:        1. To estimate the efficacy and determine the feasibility of an integrated intervention,          addressing both health protection and health promotion in order to reduce MSD symptoms          and improve health behaviors among healthcare workers. We will assess between-group          differences in MSD symptoms, health behaviors, including physical activity, and a set of          secondary outcomes, including unplanned absence, reported injuries, worker compensation          claims and costs, turnover and retention, intention to leave the job, and work-role          function. This study will explore the working hypothesis that: Workers employed at          baseline in patient-care units receiving the intervention will report greater reductions          in their MSD symptoms (primary outcome) and greater improvements in health behaviors,          compared with workers employed at baseline in units assigned to the Usual Care control          group.        2. To determine the factors in the work environment which contribute over time to          reductions in MSD symptoms and improvements in safe and healthy behaviors. (1) The work          environment, work organization, and psychosocial factors, measured in our current study,          will be associated with changes in workers' health behaviors and health outcomes between          the assessments in the current and proposed studies; (2) Improvements in the work          environment over time will be associated with improvements in workers' health behaviors          and health outcomes. We will conduct multilevel modeling analysis to evaluate the          simultaneous effects of worker-level and unit-level factors on MSD symptoms and safety          and health behaviors.   "
110409|NCT01840826|"     Project Re-Engineered Discharge (Project RED) has previously demonstrated that patients who     received the RED were 30% less likely than patients receiving usual care to access inpatient     or emergency services within 30 days of discharge. In this project, the investigators add a     new dimension to RED by integrating screening, referral and treatment for depression into the     original RED intervention and determining if this enhanced intervention increases the     effectiveness of RED in preventing readmissions and controlling costs in the 180 days after     discharge for patients with signs of depression.   "
110321|NCT01841970|"     Hemorrhoids are vascular cushions in the anal canal. People are normally born with     hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids     typically cause symptoms when they enlarge over time. There are two types of hemorrhoids-     External Hemorrhoids and Internal Hemorrhoids.      Current minimally invasive technologies for the treatment of internal hemorrhoids are     associated with several drawbacks that include high rate of recurrence and a need for     repetitive procedures, frequent post-procedural pain or significant discomfort,     intra-operative pain and technically demanding. The purpose of this study is to determine     whether the HET Bipolar System is safe and effective in the treatment of Stage I and Stage II     hemorrhoids (internal hemorrhoids). The HET Bipolar System is a new alternative device for     the minimally invasive treatment of Stage I and Stage II hemorrhoids that incorporate design     features with the intent of resolving each of the major limitations of currently available     technology.   "
110322|NCT01841957|"     To evaluate the safety and efficacy of treating visually significant bilateral cataract with     the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the     conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select     patient population.   "
110323|NCT01841944|"     The aim of the present study is to investigate the possible effects of supplementation with     1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during     a follow-up period of 2 years in an elderly population after having experienced an acute     myocardial infarction.      The hypothesis is that this supplementation on top of modern therapy will reduce the combined     cardiovascular end-point of death, non-fatal myocardial infarction, stroke and     revascularizations with at least 30%.   "
110324|NCT01841931|"     The purpose of this study is to examine whether buprenorphine can be at least as effective as     other opioid medications in relieving chronic pain in patients who suffer from dependence on     their opioid medications, while patients simultaneously experience progressive decline of     pain along with absence of opioid withdrawal symptoms and improved quality of life.   "
110325|NCT01841918|"     The purpose of this study is to evaluate immune response and safety of live attenuated     influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,     Thailand in healthy Thais.   "
110374|NCT01841281|"     The major impact of this study will be to identify the adult severe asthma cohort that will     benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of     adult severe asthma patients will respond to supplemental L-arginine and derive clinical     benefit from the addition of this therapy to standard-of-care asthma medications. The     investigators hypothesize that the patients that benefit most will have low exhaled nitric     oxide concentrations (< 20 ppb) at baseline.   "
110326|NCT01841905|"     The investigators are conducting a study to try to improve our ability to identify older     adults who are at high-risk for progression to Alzheimer's disease, several years before they     have symptoms that might reduce their quality of life. The investigators believe they can     increase the sensitivity of tests of memory and problem solving, by using a very small dose     of a medication (scopolamine) that reduces the activity of the principal chemical system in     the brain that is changing in the earliest stages of Alzheimer's disease. By pairing this     micro-dose drug challenge (that is administered with a tiny needle placed just under the     surface of the skin on the forearm), with our tests of memory and thinking, it is believed     that the investigators can create a stress test that is very similar in concept to the use     of the exercise treadmill to make the results of a heart EKG more sensitive to detect early     disease, as a cardiac stress test for heart disease. The investigators want to create a     similar stress test for Alzheimer's disease (AD).   "
110327|NCT01841892|"     Methadone is effective for heroin addiction, but many methadone patients continue to use     cocaine. High magnitude and long-duration voucher-based abstinence reinforcement, in which     participants receive vouchers exchangeable for goods and services contingent on providing     drug-free biological samples, is one of the most effective treatments for drug addiction and     can maintain cocaine abstinence over extended periods of time. Our research on a model     Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which     participants must provide drug-free urine samples to access the workplace and maintain     maximum pay, can maintain cocaine abstinence and reduce drug-related HIV risk behaviors over     extended time periods. Our next challenge is to disseminate employment-based reinforcement     for the treatment of drug addiction. The investigators propose to develop, manualize, and     pilot test a community-friendly Therapeutic Workplace intervention that can be implemented     widely throughout the US and elsewhere. Methadone patients who use injection or crack cocaine     during methadone treatment will be invited to participate (N = 58) and randomly assigned to     one of two groups: Usual Care (control) group or Community Therapeutic Workplace group. As in     our prior implementations of the Therapeutic Workplace intervention, Community Therapeutic     Workplace participants will enroll in Phase 1 to initiate drug abstinence and acquire job     skills. Participants who initiate abstinence and acquire job skills in Phase 1 will be hired     into community workplaces with collaborating employers in Phase 2. During Phase 2,     employment-based abstinence reinforcement contingencies will be implemented using procedures     for workplace drug and alcohol testing overseen by the US Department of Transportation. Using     this system, a national provider of Drug-Free Workplace Services will arrange random drug     testing and employment-based abstinence reinforcement contingencies in which employees will     be required to remain drug-free to maintain employment. The investigators hypothesize that     participants in the Community Therapeutic Workplace group will provide more drug-free     samples, and engage in fewer HIV-risk behaviors than participants in the Usual Care group.     The study will provide vital information on the acceptability of the intervention to     participants and employers, and provide preliminary data on the effectiveness of the     investigators procedures to maintain abstinence and promote employment.   "
110328|NCT01841879|"     The investigators are designing and testing the effectiveness of an integrated tobacco     control and occupational health (OH) intervention aimed at promoting tobacco cessation among     workers and supporting the adoption, implementation, and enforcement of tobacco control     policies in 20 manufacturing worksites in the greater Mumbai region of India.   "
110329|NCT01841866|"     Laryngeal mask airway (LMA) is widely used in children.The appropriate time to remove     laryngeal mask airway is still inconclusive.Sore throat is one of common complications after     general anesthesia. Sometimes postoperative sore throat affects patients' satisfaction and     daily activities. It can be correlated with dysphagia and may limit oral intake especially in     children.The incidence of postoperative sore throat after laryngeal mask airway insertion     varies from 5.8-34% in adult(13) and 17.5% in pediatric.Somehow, almost the studies of     postoperative sore throat after laryngeal mask airway removal were done in awake state. Our     study object to test that post operative sore throat after LMA removal in deep anesthetized     children is lower than awake children.   "
110330|NCT01841853|"     The aim of this research project is to evaluate a health-promoting and disease-preventive     intervention for older foreign-born adults. The overarching goal of the intervention is to     preserve participant's health, quality of life, and minimize their need of medical care.   "
110410|NCT01840813|"     Administration of intraumbilical misoprostol to women with retained placenta despite active     management of third stage of labour reduces the need for manual removal of placenta and the     amount of blood loss vaginally.   "
110331|NCT01841840|"     Stroke is the third leading cause of death in the United States. Of those who are affected by     stroke, a third becomes permanently disabled. Risk factors for stroke include, but are not     limited to, advancing age, physical inactivity, arterial stiffness, and most commonly, high     blood pressure. Stroke is a major form of a much boarder problem, cardiovascular disease     (CVD). CVD is considered the primary cause of death in the US. Interestingly, increased     arterial stiffness of elastic arteries (carotid and aorta) has been shown to be strongly     correlated to CVD and stroke. Increased arterial stiffness is considered an independent risk     for the development of CVD and stroke. Hence, arterial stiffness has been suggested as a     potential therapeutic target for CVD and more specifically stroke.      Recently, whole-body vibration (WBV) exercise has been proposed as a new and effective method     to improve muscle mass and muscle strength in younger and older individuals. It is known that     systemic arterial stiffness decreased 40 min after a single WBV session in healthy men. In     our laboratory, we have shown that leg arterial stiffness decreases after a session of WBV.     Taken together, this data seems to suggest WBV may be used as a viable way to decrease     arterial stiffness. Special populations, such as post-stroke patients, may be unwilling or     unable to perform WBV exercise so an inactive form of exercise (vibration) therapy is needed.      Passive vibration (PV), allows patients to lie in an inactive, supine position, with their     legs placed onto the vibration plate. This exposes the lower limbs to continuous vibration     without performing voluntary muscle contraction. PV has been shown to increase skin blood     flow on the vibrated extremity through vasodilation in healthy individuals and type 2     diabetics. Previous work in our laboratory has demonstrated that a 10-min session of PV on     the legs decreases augmentation index (AIx) , a marker of pressure wave reflection, as well     as leg and systemic PWV through decreases in local peripheral resistance in young men.     However, the effects of PV on arterial function in post-stroke patients are unknown.      It is hypothesized that post-stroke patients will demonstrate a decrease in leg PWV and     central AIx. However, greater responses are expected with the lower vibration frequency.   "
110332|NCT01841827|"     We will use Cilostazol as a tool to investigate its headache inducing effects in migraine     patients.   "
110333|NCT01841814|"     The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months     during the therapeutic management of patients with lymphoma.   "
110334|NCT01841801|"     To assess the safety and tolerability for the extended wear of an experimental air-activated     self adhesive patch.   "
110335|NCT01841788|"     A disposable, air-activated, adhesive backed heat patch is being developed to provide     temporary relief from minor muscular ache and joint pains associated with overexertion     strains and sprains as well as minor pain associated with arthritis. The aim of the study is     to determine the safety and tolerability of the patch during normal wear conditions.   "
110336|NCT01841775|"     Multicenter prospective follow-up of a not controlled chronic hepatitis C genotypes 2/3     patients cohort with treatment indication with interferon α 2b and ribavirin for 24 weeks,     and the verification of sustained virological response at week 48.      The eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic     Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health:      http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf   "
110393|NCT01841034|"     Male infertility is a multifactorial disease process with a number of potential contributive     causes. Considering the majority of male infertility cases are due to deficient sperm     production of unknown origin, environmental and nutritional factors must be evaluated. The     purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement     (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile     men with oligoasthenozoospermia.   "
110337|NCT01841762|"     SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric     validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with     pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of     which they will receive macitentan, 10 mg, once daily.      The primary objectives are to demonstrate the final content validity of the PAH SYMPACT     instrument, to demonstrate the psychometric characteristics of reliability and construct     validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT     instrument to detect change. The secondary objective is to assess the safety of macitentan in     patients with pulmonary arterial hypertension. The exploratory objective is to explore the     effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in     patients with pulmonary arterial hypertension.   "
110338|NCT01841749|"     The rate of axillary dissection avoided in patients with Ductal Carcinoma in Situ (DCIS) and     a mastectomy indication will be obtained by calculating the proportion of women with GAS     in-patient population that will prove to be DCIS or DCIS-MI + CCI. A confidence interval of     95% will be deferred.   "
110339|NCT01841736|"     This randomized phase II trial studies how well pazopanib hydrochloride works in treating     patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth.   "
110340|NCT01841723|"     This phase II trial studies how well ibrutinib works in treating patients with hairy cell     leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth.   "
110341|NCT01841710|"     This proposal describes a pilot study aimed at determining whether genetic variations in     taste receptors determine differential taste tolerability of pediatric medications.   "
110342|NCT01841697|"     This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with     type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The     primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c     (A1C) in participants treated with omarigliptin is non-inferior to that in participants     treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior     to the double-blind treatment period.   "
110343|NCT01841684|"     This study will evaluate the safety and effect of anacetrapib on low-density     lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary     hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a     greater extent than treatment with placebo.   "
110441|NCT01840410|"     This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult     and adolescent patients with visual impairment due to choridal neovascularization (CNV).   "
110442|NCT01840397|"     The hypothesis of this study is to find evidence if there is an influence of spine surgery on     the serum levels of two proteins secreted from neuronal cells.   "
110443|NCT01840384|"     This study is initiated to investigate the effect of multi micronutrient supplementation for     12 months on serum haemoglobin level in Indonesian young children.   "
117422|NCT01749085|"     The study aims to determine what effect a high fat meal will have on the drug exposure of     PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4)     inhibitor on drug exposure of PF-04449913.   "
110344|NCT01841671|"     The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV, two     doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to provide     evidence for better immunization policy making in regions of the world that must switch to     use of IPV/bOPV schedules in the 2014-2015 time frame. The goal is to identify the best     option optimizing humoral immune responses, intestinal immunity and thereby prevent community     transmission as well as preventing VAPP. Specifically, the study seeks to show that both of     the sequential regimens are equivalent (not-inferior) to the 3-dose IPV regimen in the     seroconversion rates to both type 1 and type 3 poliovirus such that not more than 10% of     subjects fall below the 95% confidence interval observed for the 3-dose IPV alone regimen and     the geometric mean titers (GMTs) are no more than 2/3 logs less than those for the 3-dose IPV     regimen. In addition, the study will evaluate by a novel method (poliovirus shedding index),     the adequacy of IPV vaccines in inducing intestinal immunity, specifically by reducing the     shedding of poliovirus type 2 after an OPV challenge. The hypotheses of the study are:        -  A 3-dose IPV/bOPV sequential schedule including 1 or 2 doses of bOPV is non-inferior in          terms of types 1 and 3 seroconversion rates and GMTs to a 3-dose IPV schedule.        -  Two and possibly 1 IPV dose(s) provides significant seroconversion rates and GMTs to          type 2 poliovirus and sufficient priming to induce a rapid immune response in the          context of an oral challenge at 7 months of age.        -  Three, 2, and possibly 1 dose of IPV will induce intestinal immunity to poliovirus type          2 as measured by a combination of quantity of virus in stools and duration of shedding          (shedding index).      In addition to these 3 hypotheses, the study will explore the following hypothesis:      • Co-administration of bOPV and rotavirus at 16 weeks of age (the second rotavirus dose)     provides similar antirotavirus IgA seroconversion rates and GMCs compared to subjects     receiving rotavirus vaccine together with IPV.   "
110345|NCT01841658|"     The objective of this study is to identify genes whose expression is potentially modifiable     due to changes in folate intake and help delineate mechanisms accounting for the variability     in individual response to folic acid supplementation. The study will be conducted in normal     weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic     acid.      It is hypothesized that (1) a change in folate status, induced by the supplementation, will     influence the DNA methylation of specific genes and (2) the DNA methylation response to folic     acid supplementation may differ between the normal weight and the obese women of childbearing     age.   "
110346|NCT01841645|"     The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from     dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was     carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy     fat restriction, followed by an eight-week repletion period consisting of intake of a butter     naturally enriched with CLA. Changes in body composition, fasting glucose and insulin,     inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid     composition of lipid classes are evaluated after depletion and repletion phases.   "
110347|NCT01841632|"     MultiStem ® is a new biological product, manufactured from human stem cells obtained from     adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune     system function and augment tissue repair.      Standard of care pharmacological immunosuppression after liver transplantation can achieve     reasonable survival of liver grafts and patients. The side effects of this treatment,     however, are clinically significant and diminish the overall success of organ transplantation     as a curative therapy. It is therefore the objective of this study to implement cellular     immunomodulation therapy with MultiStem as an adjunct to standard pharmacological     immunosuppression with the ultimate goal of significantly reducing drug-based     immunosuppression.      As this is the first study with MultiStem in this subject population it has been designed as     a safety and feasibility trial. However, first evidence of a potential benefit for this     patient population will be explored cautiously.   "
110348|NCT01841619|"     The purpose of this research study is to show that non-steroidal treatment with intravenous     immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous     lupus erythematosis (CLE) patients.   "
110349|NCT01841606|"     Ondansetron is a medication routinely given to mothers having cesarean deliveries to help     prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects     of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under     spinal anesthesia.   "
110350|NCT01841593|"     The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the     blood, and how it is affected if raltegravir is taken at the same time as another medicine     for high blood pressure (amlodipine). Many patients with HIV will also have high blood     pressure, so it is important to know which drugs for each of these conditions can be taken     together without affecting how well they work individually.      Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks,     with the middle week being on both drugs. The investigators will look at and compare the     levels of these two drugs in the blood after subjects have taken them separately and both     together.      This study is randomised into two groups with both study medications received by all     participants in a three-period crossover pattern; randomisation determined which medication     was taken first. Once randomised allocation was performed, medications were administered in     an open-label fashion.   "
110351|NCT01841580|"     Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million     have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk factor     in glaucoma, and reducing intraocular pressure to a consistently low level can delay disease     progression and therefore, blindness.6 Topical intraocular pressure -lowering medication     remains the first-line treatment for glaucoma, with surgical intervention playing a secondary     role in cases suboptimally controlled with medication alone.      In this study, we plan to assess the change in tear proteins in trabeculectomy patients     before and after operations. It is hoped that this study could help us gain more     understanding of the possible mechanism accounting for the development of dry eye disease in     glaucoma patients, which could help us develop better screening modalities and therapeutic     agents for glaucoma patients at risk to prevent the development of dry eye disease.   "
110352|NCT01841567|"     The overall rationale for this study is to evaluate the clinical performance potential for     Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less     dressing change due to high absorption capacity. This study is a part of Post Market Clinical     Follow-Up (PMCF).   "
110353|NCT01841554|"     To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for     repair of functional mitral regurgitation.   "
110354|NCT01841541|"     Training and engaging of unpaid informal providers (such as tea-sellers, women's groups,     youth clubs, small traders and religious groups) from poorer localities in TB disease     recognition, referral and community awareness raising will increase the access of TB patients     to formal health facilities and decrease their delay in initiating TB treatment.   "
117524|NCT01747629|"     The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus     placebo in subjects with persistent asthma.   "
110355|NCT01841528|"     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of     childbearing age. However, the optimal infertility treatment for PCOS patients is still a     matter of controversy. Despite producing more follicles and more oocytes than other women     undergoing controlled ovarian hyperstimulation during an IVF cycle, women with PCOS have     comparable or lower pregnancy rates. Additionally women with PCOS patients undergoing IVF     have a higher risk of developing ovarian hyperstimulation syndrome (OHSS), which may be     aggravated by pregnancy after an embryo transfer in a fresh cycle. Further women with PCOS     are thought to have higher rates of later pregnancy complications including spontaneous     abortion, pre-eclampsia, and preterm labor that may be related to impaired implantation in     the superovulated endometrium. We propose a randomized clinical trial of elective embryo     cryopreservation followed by a programmed cycle of endometrial preparation and frozen embryo     transfer (FET) compared to fresh embryo transfer in women with PCOS undergoing in vitro     fertilization (IVF).   "
110356|NCT01841515|"     Prolonged Collagen/Epinephrine - closure time (CEPI-CT) indicates platelet dysfunction in CKD     patients taking antiplatelet agent. The synthetic vasopressin derivative, Desmopressin     (DDAVP) shortens the prolonged bleeding time and improves platelet dysfunction measured by in     vitro closure time: CEPI-CT in uremic patients. Desmopressin also antagonizes the in vitro     platelet dysfunction induced by GPIIb/IIIa inhibitors, clopidogrel and aspirin. The     investigators designed a prospective study to evaluate the effect of desmopressin on platelet     function, as measured by in vitro collagen/epinephrine - closure time, in uremic patients who     were taking antiplatelet drugs.   "
110357|NCT01841502|"     Hepatitis C (HCV) infected patients are often in need for an antidepressant. The introduction     of Direct Acting Antivirals such as telaprevir has greatly improved treatment outcome of HCV     infected patients.Telaprevir has been studied with one antidepressant, escitalopram: plasma     concentrations of the antidepressant were reduced by 35% and without dose adjustment this may     lead to inadequate treatment of depressive symptoms. There is a need for more data on     telaprevir drug interactions with other antidepressants.      For a number of reasons, paroxetine may be a good candidate for use together with     telaprevir-containing HCV treatment.      The interaction between paroxetine and telaprevir has not been studied before.   "
110358|NCT01841489|"     This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to     Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on     GS-9973 Pharmacokinetics.   "
110359|NCT01841476|"     Phase I study to determine and compare the safety/tolerability of single ascending doses of     POL6326 by intravenous infusion.   "
110360|NCT01841463|"     -  An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05          Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with          Advanced or Inoperable Malignant Melanoma with BRAF Mutation        -  The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose          limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in          melanoma patients with BRAF mutation   "
110361|NCT01841450|"     The purpose of this study is to assess the long-term safety of the Glaukos® iStent®     Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract     surgery only, in subjects with mild to moderate open-angle glaucoma.   "
110362|NCT01841437|"     The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular     Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to     moderate open-angle glaucoma.   "
110661|NCT01837537|"     The purpose of this study is to meet the respiration rate accuracy specifications for the     study pulse oximeter monitoring system (study device) in a hospitalized volunteer population     when compared to established technologies for measuring parameters related to respiration,     such as Capnograph Respiration Rate (RR)(CO2).   "
110363|NCT01841424|"     Obesity is becoming more common and disproportionately affects the younger generation, the     poor and certain ethnic groups. Nearly 50% of reproductive aged women are obese or     overweight. Obesity during pregnancy leads to higher rates of hypertensive disorders,     stillbirth, less successful breastfeeding, obesity in their offspring, postpartum depression,     and higher weight retention postpartum. Dietary counseling can prevent excessive maternal     weight gain and is more effective than activity-based interventions. The two objectives of     this study are 1) to use community-based techniques to improve dietary counseling for high     risk women and 2) to randomize obese women to dietary counseling at Truman Medical Center and     measure their success. The hypothesis is that dietary interventions can successfully be     tailored for high risk women and that excessive weight gain during pregnancy can be avoided.   "
110364|NCT01841411|"     N-Acetyl cysteine (NAC) is an amino acid with strong antioxidant, mucolytic and antibacterial     properties, and is produced within the human body.Its effect in biofilms has been tested in     several bacteria. Biofilms have recently been observed in 90% of subjects with bacterial     vaginosis (BV) with Gardnerella vaginalis being the predominant species. Although a wide     range of antimicrobial agents are currently available, treatment options for controlling BV     are still limited. Furthermore, the number of relapses are increasing and require alternative     treatments. This study is aiming to evaluate the role of NAC in treatment of BV and     prevention of recurrence.   "
110376|NCT01841255|"     Background - Preoxygenation is performed before general anesthesia to increase the oxygen     reserves of the body and prolong the safe period of apnea without hypoxia. However, it is     often impossible to obtain a perfect face mask fit, and optimal end-tidal fractional oxygen     concentration (EtO2) are not attained. The investigators designed a new oropharyngeal     preoxygenation device, UMOX™, to avoid leaks during preoxygenation. In this study, the     investigators compared the efficacy of UMOX™ with that of a conventional face mask.      Methods - In 50 healthy volunteers breathing 100% oxygen from a circle absorber system for a     5 minute-period, the investigators compared preoxygenation using the 1) a conventional mask;     2) UMOX™ without any instruction; 3) UMOX™ with instruction on mouth breathing; and 4) UMOX™     with a nose clip, in random order. Each subject underwent all steps with a 10-minute rest     period of room air breathing between each step. Inspired and end-tidal respiratory gases were     measured every 10 seconds. EtO2 variation was analyzed using Anova.   "
117536|NCT01747473|"     Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse     subject population during severe signal interference over a specified saturation range.   "
110365|NCT01841398|"     People who originate from the Indian subcontinent known as South Asians are the fastest     growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity,     type 2 diabetes and heart disease. They also develop these risk factors at significantly     lower body weight and at younger ages compared to people of European origin. The purpose of     SAHARA (South Asian HeArt Risk Assessment) Trial, is to recruit 330 South Asians from Ontario     (Principal Investigator: Dr. Sonia Anand) and British Columbia (Co-investigator: Dr. Scott     Lear), who use the internet, email and other multimedia devices. Among these participants,     the investigators will compare the effectiveness of a 12-month interactive multi-media health     behaviour intervention to usual care in reducing cardiac risk factors. This intervention     enables participants to set their health goals and provides health messaging and feedback     designed to improve their smoking, dietary habits and physical activity. In addition, the     investigators will test if knowledge of genetic risk for heart attack influences behaviour     change and their heart health risk factor profile. The information generated from SAHARA will     enable individuals, physicians, health professionals, and policy makers to develop risk     factor modification programs to prevent cardiovascular disease in this high-risk group.   "
110366|NCT01841385|"     The aim of this study was to evaluate the influence of a fitness program from the application     of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in     women.   "
110367|NCT01841372|"     The purpose of this study is to determine if use of a virtual reality platform, Second Life,     is more effective than traditional face-to-face methods for maintaining weight loss in     overweight and obese individuals.   "
110368|NCT01841359|"     The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce     the frequency and severity of hypoglycemia in individuals who have had gastric bypass     surgery.   "
110369|NCT01841346|"     The investigators will look at the short- (in hospital) and long- term ( 1 year)outcome in     consecutive patients who undergo stent implantation and angioplasty in Jordan.   "
110370|NCT01841333|"     This phase II trial will test whether the Hedgehog signaling pathway inhibitor PF-04449913     can decrease disease relapse in high-risk patients with acute myeloid leukemia after donor     stem cell transplant.   "
110371|NCT01841320|"     This research examines the effectiveness of an intervention that employs seek, test, and     treat strategies for Vietnamese injection drug users (IDU) and their network members, by     ensuring that high risk individuals are sought for HIV testing and promptly referred to and     maintained on antiretroviral therapy (ART). HIV prevention interventions are provided to IDUs     who test HIV-negative, as well as those who test HIV-positive. HIV-positive IDUs will be     referred to HIV care through a two-arm randomized controlled trial to compare the effects of     different levels of engagement in care on ART uptake, ART adherence, and treatment outcome.   "
110372|NCT01841307|"     The overall purpose of this project is to develop and validate a simple, non-invasive method     to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient     setting, the investigators will compare the quantity of cromolyn detected in urine collected     overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn     sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6     either awaiting or recently undergone lung transplantation) with clinical and laboratory     evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting,     the investigators will compare the quantity of cromolyn detected in urine collected overnight     after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by     10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung     transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with     microaspiration.   "
110373|NCT01841294|"     Surgical resection is the best treatment option for colorectal cancer. Despite this radical     approach, recurrences within five years are still common. Several authors have proposed that     the immunosuppressive state surrounding the perioperative period was a key element of cancer     cells spread.      A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of     the innate immune system. Several factors of the perioperative period can reduce activity of     NKs such as stress, pain, opioids and general anaesthetics.      Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal     surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption,     ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic     inflammation as well.      The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries     for colorectal cancer resection will preserve NKs activity.   "
110394|NCT01841021|"     The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in     patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of     SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. It     is not known if brentuximab vedotin is better or worse than other treatment patients might be     given.   "
110375|NCT01841268|"     This study is designed to compare the skin lipid and protein composition between term and     premature infants and determine how the skin composition changes over the first four weeks of     life. The investigators hope to elucidate the unique characteristics of premature skin by     measuring the lipid and protein content in skin, how it changes during the first month of     life, and how it varies with formula feeding versus breast feeding. Additionally, the     investigators will study the relationships among diet, skin composition and plasma lipids in     premature infants over the first four weeks of life.   "
110406|NCT01840865|"     The beneficial effect of daytime sleep on memory consolidation has been shown in young,     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity     typically occuring during SWS has been implicated in the consolidation effect. In this study     we investigate if the consolidation effect can be amplified by the application of a weak     transcranial oscillatory electric current within the frequency range of SWS in humans     (0,7-0,8 Hz) during daytime SWS.   "
110407|NCT01840852|"     The purpose of this study is to investigate sleep disturbances during Acute uncomplicated     diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes     REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.   "
117537|NCT01747460|"     To determine accuracy specifications of the Pulse oximeter.   "
110377|NCT01841242|"     Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long     term despite the use of many effective drug treatment in reducing morbidity and mortality. In     this context, cardiac resynchronization (CR), either alone or combined with a defibrillator     function, has improved by about 30 to 40% of morbidity and mortality in this population of     patients with heart failure. The information on the CR are now well established for patients     with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%),     presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal.     As a result, the number of implanted devices continue to grow even if the implant procedures     of cardiac resynchronization devices (CRD) are long, difficult and associated with     significant complications with a risk of reoperation estimated between 10 and 15% . One of     the most feared during implantation devices stimulation or defibrillation risk is represented     by the risk of infection that will lead inevitably to explantation of the device. Despite the     use of several preventive measures, including the use of an antiseptic shower, a local     preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic     prophylaxis clinical studies the most recent have clearly demonstrated that the risk of     infection was associated with the duration of the intervention and was higher for procedures     CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term.     Infections of implantable devices are associated with a poor prognosis, even in an excess     mortality. It has been shown that the majority of infections may be linked to local     contamination during surgery reinforcing the idea that prevention is mainly based on local     measures and the reduction of operating time.   "
110378|NCT01841229|"     Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive     hypoglycemic effects, including improvements in glycated blood proteins[HbA1c], fasting     glucose, fasting insulin, and the homeostasis model assessment of insulin resistance     [HOMA-IR]).   "
110379|NCT01841216|"     The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the     treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises     which activate the Gmed and Gmax, but limited research remains on exercises involving     resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and     TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy     and low back pain patients while performing exercises with and without resistance. Methods: A     convenience sample of healthy subjects and patients diagnosed with non-radicular low back     pain will be recruited. Exclusionary criteria will include: current low back or lower     extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms.     Surface electromyography will be used to quantify the activity level of the gluteal muscles     and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance     Tubing and Stability Trainer. The maximal voluntary isometric contraction (MVIC) will be     established for each muscle group and the order of exercises performed will be randomized to     minimize the effect of fatigue. Following the completion of each exercise, the patient will     rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for     Exercise (RISE). The EMG signals will be smoothed and rectified and analyzed using a     root-mean-square algorithm. Clinical Relevance: The results of this study will allow     clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit     the TFL involvement, in the treatment of low back pain.   "
110380|NCT01841203|"     A dual POC immunoassay simultaneously detecting non-treponemal and treponemal antibodies was     developed for the diagnosis of infections with T. pallidum. The assay is designed for use in     resource-limited settings where challenging conditions (such as lack of electricity, running     water, or laboratory equipment) commonly exist. We sought to compare performance of the     dual-POC assay for diagnosis of yaws infection with that of the RPR and TPHA as reference     standards.   "
110381|NCT01841190|"     The purpose of this study is to compare the tendency of plasma concentration and clearance of     procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and     septic shock with another marker of early prognosis represented by 48 hours delta sofa.   "
110382|NCT01841177|"     Children with congenital heart disease have significant morbidity including low cardiac     output syndrome and subsequent organ dysfunction that may be prevented by optimization of     circulatory function. More than half of these children receive milrinone. Clinical evaluation     cannot distinguish between patients with sub-therapeutic, therapeutic, and toxic milrinone     drug levels. Consequently children who require pharmacologic circulatory support may be     receiving sub-optimal dosing, and children who do not need milrinone may be receiving     milrinone unnecessarily. The primary objective of this study is to determine if optimizing     milrinone levels with therapeutic drug monitoring in critically ill children following     cardiac surgery improves clinical outcomes and reduces the duration of milrinone infusion.     This study hypothesizes that optimizing milrinone levels with therapeutic drug monitoring in     critically ill children following cardiac surgery will improve clinical outcomes and reduce     the duration of milrinone infusion.   "
110497|NCT01839682|"     This post-market surveillance research project consists of data collection at specified time     points using standard questionnaire instruments to compare pain level, mobility and function     pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT®     Bone Cement, an FDA approved product used in the standard treatment of vertebral compression     fractures.   "
110383|NCT01841164|"     The trial is an investigator-driven research study in subjects with intermittent asthma, the     aim of which is to explore the likelihood of a functionally important separate leukotriene E4     (LTE4) receptor in airways and/or inflammatory cells in human subjects with asthma.      Mostly on the basis of experiments in mice models, the prevailing view suggests that the     present class of anti-leukotriene drugs are insufficient because they do not block the     pro-inflammatory and bronchoconstrictive effects of LTE4. It is established by us and other     groups that LTE4 is the most stable and long-lived leukotriene.      The study will establish the effect of oral treatment with the highly selective     CysLT1-receptor antagonist, montelukast, on bronchial responsiveness to inhaled LTE4 in     subjects with intermittent asthma   "
110384|NCT01841151|"     The purpose of this study is to investigate if neurofeedback and working memory training     improves core symptoms of ADHD in children and adolescents.   "
110444|NCT01840371|"     The investigators study is the randomized controlled study for analyzing clinical benefit of     pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde     cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse     effect during ERCP as the primary end point between two group. The investigators will also     access satisfaction score for endoscopist and patients as the secondary end point.   "
110445|NCT01840358|"     The purpose of this study is to determine if patients have more hypoglycemic episodes the     first 3 days following pump start compared to their usual number of hypoglycemias with our     actual pump initiation protocol.   "
110385|NCT01841138|"     Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have     significant changes of serum electrolytes.      A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount     of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal     results. Ingestion of a high volume of free water bears a risk for severe changes of serum     electrolytes, particularly for sodium and potassium.      In this trial, patients undergo regular bowel preparation for standard colonoscopy with     Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient     cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium,     phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure     and right before colonoscopy. The interval between both blood samples that will be compared     is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is     recorded. The quality of bowel preparation is visually rated during colonoscopy with a     validated score.      Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the     proportion of patients who have a serum sodium beyond the reference values after the     completion of bowel preparation. Secondary outcome parameters are the proportion of patients     with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of     serum electrolytes and osmolarity will be correlated with the amount of prep solution and     liquid.   "
110386|NCT01841125|"     Purpose : to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in     Alzheimer's Disease      Trial Design : A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial     with an open-label, 12-week extension   "
110387|NCT01841112|"     Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306     tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in     the study protocol.   "
110388|NCT01841099|"     Undernutrition is one of the most important health issues in Kenya. Children who are     chronically undernourished do not reach their full potential and are at increased risk of     infectious disease. Stunting occurs in a third of Kenyan children and has severe and     long-term consequences in terms of health, development, and poverty. Several studies have     shown that stunting is frequently associated with subclinical inflammation of the bowel, a     condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue'     or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases     (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut     immunomodulatory agents, but this approach has never been tried in EE.      This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine     (also called mesalazine - the safest immunomodulator used in IBD with least systemic     activity) in treatment of severely malnourished children with EE.   "
110389|NCT01841086|"     The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate     controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and     Food effect on the pharmacokinetics of sarpogrelate CR.   "
110390|NCT01841073|"     The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading     to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and     diabetes. A type of fibre - fermentable carbohydrate - may help prevent diabetes in     individuals with IGT by reducing appetite and food intake, and improving insulin sensitivity.     Although fermentable carbohydrate is not absorbed in the small intestine it is full fermented     by the colonic bacteria. The fermentation of this carbohydrate produces short chain fatty     acids which act on specific G protein coupled receptors (GPR41/43) in the intestine to     release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres in the brain     to decrease appetite. GLP-1 incretin effects and possible effect of the beta cell will     increase insulin sensitivity. Short chain fatty acids also suppress the release of free fatty     acids from adipocytes. Lower levels of free fatty acids in insulin resistant subject's leads     to improved insulin sensitivity. This body of work will examine the effect of fermentable     carbohydrate on appetite, weight loss, blood glucose control which will give an indication of     the possibility of fermentable carbohydrate to prevent type 2 diabetes in this at-risk group.   "
110391|NCT01841060|"     Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are     not operable because of their condition or respiratory problems associated with it. The     treatment is then suggested that local radiotherapy is conventionally carried out in split     mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to     complications, including post-radiation pneumonitis.   "
110392|NCT01841047|"     Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is     locoregional.      In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the     surgical resection. The effect of radiotherapy combined with surgery is uncertain and until     now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to     high risk of organ toxicity nearby.      The helical tomotherapy is an innovative equipment radiotherapy to make conformational     radiotherapy modulation intensity and is particularly suitable for irradiations precision     (imaging mode associated with daily scanner) in large complex volumes. Increasing doses     (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical     tomotherapy should allow to improve the efficacy of radiotherapy.   "
110932|NCT01833949|"     The objective of our study was to compare the efficiency of the right ULOD using thermal     doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to     assess treatment efficiency.   "
110408|NCT01840839|"     The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is     well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its     slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory     representations. This impact of sleep on memory performance can be additionally enhanced by     exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency     range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy     subjects. If older adults that commonly experiencing cognitive decline, including long-term     retention of declarative memory - benefit from transcranial slow oscillatory stimulation     (tSOS) during sleep in the same way has not been studied so far. The primary goal of the     study is therefore to investigate the impact of oscillating current stimulation (tSOS) during     a daytime nap on declarative memory consolidation in older adults.   "
110395|NCT01841008|"     Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many     prospective studies. Prospective randomized studies versus placebo are required to confirm     the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1%     per week can reduce relapses of non-segmental vitiligo lesions.      Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs     placebo in the prevention of depigmentation in patients with vitiligo who responded to     treatment.      Secondary objectives        -  Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to          decrease the intensity of depigmentation in patients with vitiligo who responded to          treatment.        -  To study the occurrence of possible adverse effects.      Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total length     of the study: 18 months      Intervention Multicentric prospective interventional randomized comparative study versus     placebo.        -  Visit V0: Selection Information of the patient, control of inclusion and non inclusion          criteria.        -  Visit V1: Control of inclusion and non inclusion criteria, patients signed informed          consent. An initial clinical evaluation and photographs in direct sunlight and UV.          Topical treatment (tacrolimus or placebo) will be delivered to the patient by the          hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.        -  Visit V2:      The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for     final evaluation. A clinical assessment will be made and photographs in the same way as the     inclusion. Adverse reactions during treatment will be collected by the investigator (they     will be noted as and when the patient in a notebook that will be presented at baseline).      The percentage of depigmentation will be evaluated in a blinded treatment of photographs by     two reviewers. In case of disagreement, the opinion of a third appraiser will be required.      - End of study: After the end of the study patients will be supported via the usual care     recommended for their condition.      Evaluation criteria        -  primary endpoint           ---Percentage of patients at 24 weeks without depigmentation (depigmentation score = 0).          A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of          direct light and UV photographs will be made by two independent observers          (dermatologists) between inclusion and after 24 weeks of treatment.        -  secondary endpoints           ---- The efficiency to reduce the intensity of relapses will be evaluated using the          score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the          VASI score (Appendix 4).        -  The frequency, severity and time of occurrence of adverse events are reported. Side          effects are classified into grades according to WHO criteria.      Number of subject Considering that depigmentation occurs in more than 40% of patients during     the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the     rate of depigmentation of 10%, a population of 26 patients per group will be necessary     (taking into account 10% of patients lost to follow). The total number of patients to be     included in the study will be 52.   "
110396|NCT01840995|"     The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has     the potential to cause an increase of intracranial pressure (ICP). Previous studies have     proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD)     correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased     ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.   "
110397|NCT01840982|"     This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical     trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic     index(GI) in healthy males.   "
110398|NCT01840969|"     This study is aimed to evaluate the association of common carotid artery circumferential     strain with the echocardiographic parameters of left ventricular function and the degree of     actual hemodynamic deterioration in patients undergoing multi-vessel off-pump coronary artery     bypass with preserved left ventricular ejection fraction.   "
110399|NCT01840956|"     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the     creation of vascular access for dialysis.   "
110400|NCT01840943|"     The purpose of this study is to compare the effectiveness between CAELYX and topotecan     hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma     following failure of first-line, platinum-based chemotherapy, who have received no more than     one prior platinum-based regimen therapy.   "
110401|NCT01840930|"      Cohort CP  is a multicentre cohort study, initiated by the Hospices Civils de Lyon in     September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS     IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the     rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological     and environmental data.      The primary objective is to establish the incidence of orthopaedic complications (scoliosis     and hip joint) depending on patients' age.      Secondary objectives are to describe the sequences over time of these complications and the     related pain, to explore the impact of nutrition, surgery, asymmetric postures and     environmental factors, and to describe the medical and rehabilitative follow-up of these     patients.      385 patients are expected by the end of 2016. We expect of this long-term follow-up to gain     tools that permit to improve patient's care and patient's quality of life, by putting in     place preventing actions and adapted treatments related to their own pathologies.   "
110402|NCT01840917|"     The purpose of this study is to investigate heart rate variability during Acute uncomplicated     diverticulitis by ECG-monitor (Holter), the investigators hypothesis is the inflammation     causes a decrease of High Frequency(HF)-power component of heart rate variability and this     correlates with sleep quality and daytime fatigue.   "
110403|NCT01840904|"     The purpose of this study is to investigate subjective sleep quality and fatigue during and     after Acute uncomplicated diverticulitis assessed by questionnaires and a sleep-diary. The     investigators hypothesis is that subjective sleep and fatigue are correlated with the     inflammatory activities.   "
110404|NCT01840891|"     The objective of this study is to determine the prevalence of secondary lactose intolerance     in renal transplant recipients (RTR) with chronic norovirus infection.      In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University     Hospital of Zurich, the investigators are currently aware of 10 patients with chronic     norovirus infection, which was proven by positive polymerase chain reaction (PCR) analysis of     recent stool samples, whereas chronic virus shedding is defined as more than two PCR positive     samples in an interval of at least one month. Concomitant viral (other than norovirus),     bacterial or parasitic (particularly Gardia lamblia) intestinal infections are excluded by     negative stool cultures and PCR analyses, respectively. Main exclusion criterion for the     present case series is a concomitant intestinal infection (other than norovirus) and primary     lactose intolerance, which is previously excluded by absence of the CC genotype of the DNA     variant -13910 T/C upstream in the LCT gene. After obtaining written and oral informed     consent, the investigators perform a lactose hydrogen breath (LH2BT) test and a lactose     tolerance test (LTT) in all eligible RTRs with proven chronic norovirus infection     irrespective of current abdominal symptoms.      The study population (N=10) is divided into two groups according to the gastrointestinal     symptoms (asymptomatic versus symptomatic, such as chronic diarrhoea or diffuse abdominal     discomfort). The investigators chose the cut-off three or more stools per day as indicative     of diarrhoea for the purpose of this study. RTRs with otherwise unexplainable chronic     diarrhoea but absent norovirus infection serve as control group (N=10).   "
110405|NCT01840878|"     The purpose of this study is to investigate the accuracy of actigraph measured sleep compared     to the golden standard (polysomnography) during Acute uncomplicated diverticulitis. Our     hypothesis is the actigraph is accurate for sleep-monitoring for this group of patients   "
110411|NCT01840800|"     Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional     femoral/sciatic block combinations effectively reduce postoperative pain, but results in     considerable motor blockade. The investigators aimed to evaluate postoperative pain relief     and the degree of motor block with block combinations of femoral nerve (FEM) and obturator     [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks     with isotonic saline. All patients received standard patient controlled analgesia with     morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB     approval, 81 patients were planned to be randomized to one of three USG block combinations:     Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used     for all active blocks following induction of general anaesthesia [propofol-remifentanil,     laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours     postoperatively at rest.      Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor     abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short     form-8] scores and degree of motor blockade [Jensen- Børglum motor test].   "
110412|NCT01840787|"     As new contact lens products continue to be developed and improved, it's becoming harder for     some individuals to tell whether one product is different from another. In addition, not     everyone has the same level of sensitivity of their eyes, making it difficult for these     judgments to be made. The purpose of this study is to explore the idea of using a     pre-determined expert panel of individuals who are able to tell differences between contact     lenses based on their comfort.   "
110413|NCT01840774|"     The purpose of this study is to determine how pain relief is modified when the investigators     combine the Virtual Reality based Snow World game with certain pain medications.   "
110414|NCT01840761|"     Delayed vasospasm (DCVS) is the most serious complication of aneurysmal subarachnoid     hemorrhage (aSAH) perioperative period ,the incidence rate up to 30% to 90%, and often can     cause severe brain ischemia or brain damage of delayed ischemic and even lead to cerebral     infarction, to be the main factor of deadly and severe disability . (aSAH) perioperative     delayed vasospasm (CVS) is the bottleneck to restrict the long-term effect. Since there is no     standard clinical treatment programs, limiting the advantages and characteristics of     traditional Chinese medicine to play.Guangdong Provincial Hospital of TCM is the province's     Medical Center encephalopathy, treated 100 brain aneurysm patients each year, more than 80     times craniotomies and surgical interventions , with a rich source of patiengs to carry out     the study. In this study, on the basis studies on hemorrhagic stroke of a yin and yang     syndrome and comprehensive treatment programe of the State 1995,the 15th research , in     accordance with characteristics of the pathophysiology and understanding of cause and     pathogenesis in aSAH perioperative period , through expert advice and review of the     literature, under the guidance of Liu Maocai who isChinese medicine practitioners of     Guangdong province , from diagnosis, diagnosis and treatment,prescription drugs, and other     aspects of efficacy evaluation, developmenting a standardized treatment program of delayed     CVS after aSAH . To evaluate the efficacy of the standardized program by prospective,     randomized,controlled clinical trial,improving the postoperative results, reducting     significantly the mortality and morbidity patients with cerebral aneurysms.   "
110433|NCT01840514|"     The stress of orthotopic living donor liver transplantation in patients with cirrhosis could     induce worsening of an already recorded myocardial dysfunction or may be associated with a     new myocardial dysfunction in patients previously having normal myocardial functions,     therefore this study will be designed for intra-operative detection of new onset ventricular     dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver     transplant recipient and the possible contribution of several hemodynamic and oxygenation     parameters in the generation of any cardiovascular function impairment will be also     investigated and to determine the impact of ventricular dysfunction on early (7 PO days)     graft function, 28 days survival and patient outcomes.   "
110415|NCT01840748|"     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of     the skin and several internal organs.      Pulmonary hypertension (PH) is a fatal disorder characterized by an increase in pulmonary     vascular resistance, which leads to right ventricular failure. Despite being recently the     object of greater attention and despite therapeutic advances, pulmonary hypertension due to     SSc remains associated with a dismal 47 - 67% 3-year survival. Among SSc patients     prospectively followed in the European League Against Rheumatism Scleroderma Trials and     Research (EUSTAR) cohort, 26% of death was related to pulmonary hypertension. Although some     previous data have suggested the protective effects of calcium channel blockers on the     development of pulmonary hypertension, the potential preventive effects of vasodilators for     the prevention of Pulmonary hypertension have not been determined yet. In addition to be     considered routinely for the treatment of SSc-related pulmonary hypertension, prostanoids,     endothelin receptor antagonists (ETRA) and Phosphodiesterase-5 inhibitors (PDE5i) can also be     used for this indication.      This observational trial is one out of five observational trials of the collaborative project     To decipher the optimal management of systemic sclerosis (DeSScipher).      Aim of this observational trial is:      - to compare the outcomes of adult and juvenile SSc patients who are at high risk of     developing pulmonary hypertension and are receiving either different vasodilator treatments     or no vasodilator treatment.   "
110416|NCT01840735|"     This study will determine the safety, tolerability, and pharmacokinetics of a single dose of     GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.   "
110417|NCT01840722|"     The overall aim of this study is to reduce risk behaviors and increase health and behavioral     health service utilization among disadvantaged, drug-using rural women at high risk for HIV     and HCV. This project has potential to make a significant contribution to science by     providing knowledge about the health, risk behaviors, and service utilization of a vulnerable     and understudied group of women during a time of emerging and significant public health risk     in a rural Appalachian setting. Successful completion of the aims of this project will     advance the delivery of a low-cost, potentially high impact intervention with implications     for a number of other real world settings (such as criminal justice venues) where other     disadvantaged high-risk drug users can be identified and targeted for intervention.   "
117924|NCT01742403|"     This study is investigating measurement of prostate motion during radiotherapy using the     implanted gold markers. If motion is greater than 3mm then the beam will be stopped and     position corrected (gating).   "
110418|NCT01840709|"     Psychosomatic is a new approach to understanding the phenomena of somatization using the     knowledge of medicine and psychology to treat human being. A Brief Group Psychanalytic     Psychotherapy (BGPP) for psychosomatic patients has been used to supplement the treatment of     some diseases including Systemic Lupus Erythematosus (SLE). The hypothesis of the study is     that BGPP beside clinical treatment can improve the quality of life and coping in SLE     patients. The aim of the study is to evaluate the effectiveness of BGPP in Brazilian SLE     patients.      Primary objective: To evaluate the effectiveness of BGPP to improve quality of life.     Secondary objectives: To evaluate the effectiveness of BGPP to improve coping, anxiety and     depression symptoms. SLE patients will be randomized to receive Psychotherapy or only     clinical treatment. The effectiveness will be assessed through specific questionnaires.   "
110419|NCT01840696|"     Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal     blood flow to the heart secondary to narrowing of the heart vessels.      Phase analysis is a computer method that is applied after the PET test is done. It is used to     determine when a region of the heart contracts relative to other heart regions in the heart     beating cycle. Initial data suggest that regions of the heart with abnormal blood flow change     the pattern of contraction from rest to stress conditions. That is, regions of the heart with     abnormal blood supply become dyssynchronous when compared to the normal regions of the heart.      This study will investigate whether phase analysis may aid the visual interpretation of     rubidium myocardial perfusion PET studies by determining the areas of the heart that are not     beating in synchrony with the normal heart regions. This information will be used as a proxy     for poor blood supply. The gold standard will be coronary angiography by which the percent     narrowing of the heart vessels is assessed.   "
110420|NCT01840683|"     This is an open-label, single center clinical investigation to evaluate the efficacy and     safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a     treatment for non-exudative (dry) Age-related Macular Degeneration (AMD). A total of 14     clinic visits are scheduled, one baseline visit, 8 visits for H.E.L.P. therapy treatments (to     be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be     performed one week following the 4th H.E.L.P. therapy session and 12 weeks, 24 weeks, 36     weeks and 52 weeks after the final H.E.L.P. therapy session.   "
110421|NCT01840670|"     The elliptic shape of inferior vena cava (IVC) sections, while hindering the ultrasound     measurement of IVC diameter, may provide a useful tool to estimate central venous pressure     (CVP). Hypothetically, the higher is CVP and more the ratio R between minimum and maximum     diameters approximates 1. The purpose of this study is to determine R values in four     different sections before and after a fluid load test, in order to evaluate if R is affected     by the test and at which level the variation is larger.      The secondary endpoint is to search for the parameter best predictive of the positivity of     the fluid load test among IVC minimum and maximum diameters, eccentricity, section area, and     blood velocity at the level that presented the largest variations after the fluid load.   "
110434|NCT01840501|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the     body does to the medication), potential immunogenicity (ability to induce an immune     response), and pharmacodynamics (what the drug does to the body) after administration of     JNJ-42721458 in healthy adult male participants.   "
110435|NCT01840488|"     The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat     (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or     metastatic breast cancer with disease progression after prior hormonal therapy.      This study is designed to provide necessary information on safety and dose response of     BN83495, when given by repeated once daily oral administration, while achieving a maximal STS     inhibition and a maximal reduction in plasma oestradiol (E2) and adiol levels. The data     obtained will be used to plan further clinical studies.   "
110933|NCT01833936|"     Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to     the immobilization period necessary to ensure optimal healing.      The purpose of this study is to determine if the use of neuromuscular electrical stimulation     (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.   "
110422|NCT01840657|"     X-Linked myotubular myopathy (XLMTM), a form of centronuclear myopathy (CNM) is the result of     a mutation in the MTM1 (myotubularin) gene which leads to altered myotubularin. Myotubularin     is essential for optimum muscle function. To date, over 100 mutations have been described     resulting in a range of disease onset and symptom severity. The early onset form presents     with neonatal hypotonia, muscle weakness, respiratory distress and an ongoing requirement for     continuous ventilatory support with the inability to maintain a sitting position once placed.     Males with both later onset and milder symptoms usually do not require ongoing ventilatory     support, achieve a higher maximal motor function with ability to sit when placed and even     walk, and have improved survival rates. Males with XLMTM may experience complications     (events) at birth and throughout their lifetime. The goal of the study is to identify the     number of events over twelve months in males with genetically confirmed XLMTM. Parents or     affected individuals over the age of 18 years who are able to access telephone will provide     answers to an established event survey to evaluate the frequency and types of events.     Emergency department, hospital admissions and mortality will be confirmed by obtaining     medical reports.      The investigators hypothesize that there will be no association between the frequency of     events and markers of clinical severity including the need for ventilatory support at birth,     current level of ventilatory support (no support, support less than 12 hours, support more     than 12 hours) and current motor function (walking, sitting without support, inability to sit     without support).   "
110423|NCT01840644|"     The purpose of this study is to examine the reliability and validity of the rating of     perceived exertion scale in children post severe traumatic brain injury during treadmill     exercise.   "
110424|NCT01840631|"     Aim 1 - The primary aim of our study is to assess whether group counseling is a non-inferior     intervention compared to the usual care of individual counseling in the management of     childhood obesity. In order to achieve this aim, the investigators will compare the mean     change in BMI after 6 months of intervention in the two study arms.      Aim 2 - The secondary aim of our study is to determine if the change in BMI is associated     with changes in the dietary composition, physical activity and metabolic profile.   "
110425|NCT01840618|"     Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal     imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent     girls and women capable of having children. Polycystic ovary syndrome is associated with     missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes.     Girls with polycystic ovary syndrome may have a breathing problem known as sleep apnea.     Sleep apnea may cause a person to stop breathing for short periods of time while sleeping.     People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea     than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime     sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The     purpose of this study is to understand how insulin function is affected in presence of sleep     apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls     with PCOS without sleep apnea. Insulin is one of the hormones made in your body to convert     food into energy. In people with increase weight body cannot use insulin properly. The     investigators also want to see if insulin action is also affected by sleep apnea.   "
110426|NCT01840605|"     The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate     dry syrup in the change in the severity of pruritus after the treatment period.   "
110427|NCT01840592|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     the drug sorafenib in combination with the drug doxorubicin might have on the growth and     spread of liver cancer (HCC).   "
110428|NCT01840579|"     This study using pembrolizumab (MK-3475) will be done in 5 parts. In Part A, successive     participant cohorts with advanced solid tumors will receive pembrolizumab to assess the     safety and tolerability of monotherapy. In Parts B, C, and D, participants with advanced     non-small cell lung cancer (NSCLC) will receive pembrolizumab in combination with either     cisplatin/pemetrexed or carboplatin/pemetrexed (Part B); with either carboplatin/paclitaxel     or carboplatin/nab-paclitaxel (Part C); or with ipilimumab (Part D) by non-random assignment     to assess the safety and tolerability of the combination therapy. In Part E, participants     untreated Extensive-disease (ED) Small Cell Lung Cancer (SCLC) will receive pembrolizumab in     combination with either cisplatin/etoposide or carboplatin/etoposide by non-random assignment     to assess the safety and tolerability of the combination therapy.   "
110429|NCT01840566|"     The purpose of this study is to test the safety of delivering the patients' own immune cells,     called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell     transplantation (ASCT).   "
110430|NCT01840553|"     The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets     compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to     colonoscopy.   "
110431|NCT01840540|"     To determine the safety and toxicity of intra-arterial infused autologous adipose derived     mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.   "
110432|NCT01840527|"     This primary purpose of this study is to obtain blood samples from participants with both     early and later stages of melanoma (Stage II/III and Stage IV). The researchers hope to     better understand an abnormal protein found in many melanoma tumors called the BRAFV600     mutation.      There will be two separate cohorts (groups) of participants on this study. You will be placed     in one of the Groups.      Group 1-For participants with advanced melanoma: Your existing tumor tissue sample will be     compared to the blood samples given in order to further analyze and to understand the     BRAFV600E gene mutation.      Group 2-For participants with stage II/III melanoma: Following surgery, blood samples will be     collected and analyzed.      Understanding the BRAFV600E gene mutation in melanoma will help the researchers better     understand the disease, and help plan treatment options for people with melanoma of all     stages in the future.   "
110452|NCT01840267|"     The pneumoperitoneum during laparoscopic surgery in pediatrics has the potential to cause an     increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic     measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP.     Therefore, this study aims to confirm the increased ICP by ultrasonographic measurement of     ONSD during laparoscopic surgery in pediatric patients.   "
110436|NCT01840475|"     Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and     reducing the burden of associated symptoms.      The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no     significant difference between naïve and pre-treated patients. The patients will be divided     in sub-groups according to the time interval between occurrence of stroke and start of     treatment (early, medium and late start of treatment according to the first and third     quartiles time distribution). It is hypothesized that the early start of treatment group     will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when     compared to the late start of treatment group.   "
110437|NCT01840462|"     The objective of this study is to investigate the efficacy of Dysport® in the treatment of     cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated     patients.   "
110438|NCT01840449|"     The aim of the study is to identify predictive factors for the response to Lanreotide     treatment in Acromegaly as well as in Neuroendocrine Tumours.   "
110439|NCT01840436|"     MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates.     Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as     extracellular matrix, by binding to structural proteins, and 2) in cells communication     process by protecting growth factors. At the site of a lesion, glycosaminoglycans are     degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By     replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix     scaffold and cells communication, a process known as Matrix Therapy.      The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the     incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of     upper aerodigestive tract cancers, when used as a preventive agent.      The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would     protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.   "
110440|NCT01840423|"     The purpose of this study is to evaluate the safety and tolerability of escalating doses of     ODM-104 when given to healthy male volunteers.   "
110449|NCT01840306|"     Primary Objective:      (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents,     considering clinical responses. (ii) To investigate associations between presence vs. absence     (or relative levels) of identified extracellular (EC) RNAs/proteins and patients'     clinicopathological characteristics, including age at diagnosis, time to progression and     overall survival, as well as correlations with serum protein biomarkers routinely analysed     for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for     the existence of RNAs/proteins identified in (i) and (ii).      Secondary Objective:      To develop a predictive model for use in the HER2 positive population based on the most     accurate and sensitive combination of the identified biomarkers.   "
110450|NCT01840293|"     Primary objective:      The primary objective is to define the proteomic and molecular characteristics of primary and     recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and     the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2     (HER2) genes      Secondary objective:        -  To expand our understanding of the complex molecular pathways dictating the progression          of breast cancer and their response to different treatment regimes.        -  To relate proteomic findings to survival data        -  To identify potential serum markers of breast cancer progression   "
110451|NCT01840280|"     The main purpose of this observational study with Irinotecan onkovis is to determine the     number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose     under the special circumstances of ambulant chemotherapy.      Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This     includes provision of appropriate packaging sizes to decrease the excess quantity to be     discarded, and thus also follows this objective.      Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end,     data regarding co-medication and adverse events are also collected.   "
110455|NCT01840228|"     Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant     death and disease. Progesterone is the single most effective intervention in the prevention     of preterm birth. However, current use of this therapy is limited to certain high-risk groups     including women with a history of preterm birth and women with a short cervix. This study     seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women     with arrested preterm labor. The investigators hypothesize that administration of vaginal     progesterone in women who present with preterm labor but remain undelivered 12 hours after     cessation of short-term therapy to inhibit contractions will result in lower rates of preterm     birth before 37 weeks' than will administration of placebo.   "
110456|NCT01840215|"     Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the     past decades. When deciding for a retrobulbar block, the local injection of varying mixtures     and volumes of fast-acting anesthetics (such as lidocaine) - with or without a     vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the     standard care to provide painless surgery while minimizing the possible risks such as     increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood     flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to play     a role in intra-operatory vision loss (a wipe-out phenomenon) in patients with advanced     glaucoma.      The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of     the anesthetic in general circulation and thus to achieve a longer effect in the orbit.     However, studies on ocular blood flow after adrenaline-containing compounds have consistently     showed a decrease in ocular blood flow, thus raising the issue of whether it should be used     in patients with known vascular dysfunction, namely glaucoma patients. Nevertheless, there     has been no study to verify this claim concerning the safety of non-adrenaline containing     anesthetics.      Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its     formulation has also been debated. The orbital pressure increase can lead to a number of     adverse reactions, not only increasing IOP but also potentially decreasing vascular input by     local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to     be less elastic than in healthy individuals, potentially making this structure less compliant     to outside compression. These more rigid orbital tissues could also impair the orbit's     ability to deal with the iatrogenic increased volume.      As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the     vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim     to study this impact through a non-invasive, widely established ultrasound based method of     ocular blood flow research (color Doppler Imaging). Potentially, our study could help     determine a taylor-made choice of the anesthesiology procedure to apply to a specific     patient, thereby advancing the current standard of care in ophthalmology.   "
110457|NCT01840202|"     Glaucoma is a leading cause of blindness worldwide, whose treatment - intraocular pressure     lowering - is only partially effective in preventing disease progression. Accordingly, other     variables, such as ocular blood flow-related factors, have been implicated in disease     pathogenesis. However, most findings involving vascular variables come from partial,     small-scale studies. Furthermore, recent technological advances have identified a number of     ocular blood flow variables that have yet to be tested in large scale trials. Therefore, a     study that specifically aims at uncovering the role of vascular aspects in glaucoma is     needed.      For this purpose, a cross-sectional, observational case-control study will be conducted in     the University Hospitals Leuven. This will be the largest-yet study on the subject, involving     more than 750 patients. This will allow the creation of a specific cohort of patients where     the vascular aspects are thought to be particularly important (low-tension glaucoma). It will     use the largest combination yet of vascular-related measuring techniques (dynamic contour     tonometry, optic coherent tomography, colour Doppler imaging and retinal oximetry)   "
110458|NCT01840189|"     The conventional glucocorticoid replacement therapy in primary adrenal insufficiency     (Addison's disease) renders the cortisol levels unphysiological, which may cause symptoms and     long-term complications.      The majority of Addison's patients have other organ-specific autoimmune disease, which poses     challenges to the replacement therapy. Of particular interest is the combination of Addison`s     disease and type 1 diabetes, since cortisol affects glucose homeostasis. The clinical     experience is that this subgroup of patients is difficult to treat, but very little research     has been done to understand and improve their situation.      Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone     infusion, and can mimic the normal diurnal cortisol rhythm. This pilot study aims to further     evaluate continuous subcutaneous hydrocortisone infusion treatment in terms of metabolic     effects especially glycemic control in patients with the combination of Addison`s disease and     type 1 diabetes in an 5 months cross-over design open clinical pilot study.   "
110515|NCT01839448|"     The main objective of the study is to estimate and compare the percentage of patients with     abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed     with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism     is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.   "
110459|NCT01840176|"     The purpose of this study is to assess the feasibility of performing prophylactic McCall     culdoplasty at the time of total laparoscopic hysterectomy. The investigators will also be     measuring pelvic support (using POP-Q) and sexual function before and at different time     points (up to 12 months) postoperatively.      The investigators hypothesize that women undergoing the McCall culdoplasty will not have     different immediate surgical outcomes (operative time, etc) and may have better pelvic     support and sexual function in the future.   "
110460|NCT01840163|"     This study examines the impact of an online decision tool for patients with early stage     invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly     diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas.     Participants will be randomized to receive either a basic version of a decision tool (similar     to existing website with breast cancer information) or an enhanced version (featuring a     knowledge building component, a values clarification exercise, and a patient activation     module). Our hypothesis is that patients who use the enhanced version of the tool will have     greater knowledge of their test and treatment options, have a higher rate of high quality     (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the     decision-making process.   "
110461|NCT01840150|"     This clinical trial studies nanoscale artificial nose (NA-NOSE) in monitoring response and     detecting recurrence after surgery or radiation therapy in patients with stage I or stage II     non-small cell lung cancer (NSCLC). Using the NA-NOSE breath test may be an effective way to     monitor response and detect recurrence of NSCLC after surgery or radiation therapy.   "
110507|NCT01839552|"     Lazanda is a prescription nasal spray medicine that contains the medicine fentanyl. It is     used to manage breakthrough pain in adults with cancer who are already routinely taking other     opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after taking     other opioid pain medicines and the patient's body has become used to them (opioid tolerant).      The purpose of this study is to assess the ability of Lazanda to control pain during an     episode of breakthrough pain in cancer patients.   "
110508|NCT01839539|"     The purpose of this study is to evaluate the efficacy of dendritic and cytokine-induced     killer cells (DC-CIK) for colorectal cancer (CRC).   "
110462|NCT01840137|"     The development of clinically relevant and scalable exercise interventions in older     cystectomy patients may have an impact upon:        -  Patients: Exercise interventions may improve patient outcomes, including quality of life          and avoidance of skilled nursing facilities.        -  Clinicians: Proving the safety and feasibility of targeted interventions in older          surgical patients may facilitate the development of clinically relevant preoperative          interventions suitable for wider study and implementation.        -  Payers: Improved surgical outcomes among high risk surgical patients will be associated          with significant cost savings.        -  Researchers: Targeted and well controlled studies focusing on improving surgical          outcomes through exercise may provide insight into relationships between patient          factors, surgical stressors and outcomes. Ultimately, such work may lead to novel          clinical approaches to optimize patients for surgery.      The investigators will study the effects of preoperative exercise training on cystectomy     patients, specifically targeting increasing functional capacity and muscular strength. Prior     to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility,     safety, and initial efficacy of preoperative exercise in cystectomy patients must be     determined. To address this issue, the investigators will complete a trial of rehabilitation     in cystectomy patients at the University of Michigan.   "
110463|NCT01840124|"     The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine     fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA     approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to     destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The     radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure.     There is minimal blood loss and pain and women return to the usual activities 5-9 days after     the Acessa procedure.      The investigators will evaluate changes in fibroid-related symptoms from before the Acessa     treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators     will also assess operative outcomes including procedure duration, complications, blood loss,     post-operative pain, and the time to return to usual activities. The investigators will     determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic     fibroids after the Acessa procedure.      Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC     Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as     the Coordinating Center for the trial with oversight of all scientific and administrative     aspects of the study. All study data will be stored securely in a HIPAA compliant, secure     database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring     board will oversee participant safety and protection.   "
110464|NCT01840111|"     The overarching goals of this proposal are to 1) identify the network of brain regions     specifically activated by personal smoking environment cues and 2) to evaluate the effects of     exposure to these cues on smoke self-administration and subjective reactivity. The results of     this study will inform the development of novel and more efficacious cue-exposures therapies     targeted at helping smokers quit smoking and will provide novel mechanism information     regarding the influence of environmental context on drug taking.      The investigator hypothesizes that cue-exposure treatments (CETs), in which drug use is     prevented during exposure to drug cues (e.g. lit cigarette) have been of limited efficacy in     part because they have not included cues representative of the contexts in which drug use     occurs. By demonstrating that context cues have a differential and robust influence on brain     and behavioral responses, we will have provided a substantial basis for including such     stimuli in the context of treatment. At the same time, we will have identified novel     mechanisms by which such stimuli promote continued drug use and relapse.   "
110516|NCT01839435|"     The aim of our monocentric prospective in intention-to-treat study is to evaluate the     feasibility of outpatient appendectomy for non complicated acute appendicitis.   "
110517|NCT01839422|"     This research attempts to better understand the altered and preserved memory mechanisms in     Alzheimer disease, particularly to better apprehend learning implicit memory processes, and     give a scientific support to non-pharmalogical interventions. At the present time, it is     possible to delay the emergence of the symptoms related to this disease, eventually to     decrease it, but not to cure it. Yet, care these patients became a crucial question and the     solutions proposed to healthy aging people are not appropriate for Alzheimer patients who     present specific disorders. The improvement of the quality of life of the institutionalized     patients lies on a better comprehension of their disorders but also of their preserved     abilities. The literature testifies of a great heterogeneity in the clinical expression of     this disease, however we noticed two constants with regard to the capabilities generally     announced as being preserved, on one hand, the implicit memory, and on the other hand the     artistic aptitudes, and more particularly musical capabilities.      Patients with Alzheimer disease present a particularly severe and early deterioration of     episodic memory. Thus, at the beginning of the disease the explicit acquisition of new     knowledge becomes increasingly difficult. However, some clinical observations, such as new     learning of unknown songs, even with patients at a severe stage of the illness, seem to     support the assumption of a preservation of some implicit learning abilities. Indeed, several     studies already showed preserved implicit memory capabilities among patients with Alzheimer     disease, mostly at the beginning stage of the illness: preserved effects of perceptual     priming, procedural learning. Thus, we are mainly interested by the effects of exposure and     the rising of a feeling of familiarity, both showing preserved implicit learning abilities,     for moderate to severe Alzheimer patients. However, no study was carried out to date using     the neuroimaging techniques, among Alzheimer patients at a moderated to severe stage of     illness, with the main objective to identify the cerebral substrates implied in the learning     of new knowledge.      Indeed, several studies already showed preserved implicit memory capabilities among patients     with Alzheimer disease, mostly were performed at the beginning stage of the illness and none     of them have studied theses learning abilities for moderate to severe Alzheimer patients.      The objective of this work is to specify, in severe form of Alzheimer disease, the cognitive     mechanisms allowing the memorizing (feeling of familiarity) of new information and thus to     highlight neural networks underlying this learning process (recently learned stimuli vs old     stimuli). The goal is to propose a positive image of the Alzheimer patients, in understanding     which cognitive mechanisms and cerebral areas allow these learning capabilities.      20 patients Alzheimer at a moderate to severe stage, 20 patients at a mild to moderate stage     of the illness, and 20 healthy aging participants, are selected after a neurological     interview and a neuropsychological evaluation. The whole of the included participants take     part of the experimental protocol organized in two phases: - the phase of familiarization and     the phase of test. The phase of familiarization consists of the repeated exposure (daily     session before the MRI acquisition) of new songs and new painting until obtaining a high     feeling of familiarity for each item. The phase of test is carried out in the 3T MRI camera,     it comprises an anatomical (T1, T2 MRI) and a functional acquisitions. The functional     acquisition corresponds to a passive listening and seeing tasks of musical and pictorial     stimuli. Finally, all participants realize a debriefing phase that allows obtaining a     feedback on the familiarity of stimuli presented during the functional acquisition.   "
110518|NCT01839409|"     The purpose of this study is to study the relationship between the vestibular system and     chronobiology   "
110465|NCT01840098|"     The purpose of this study is to investigate metabolic effects of 3 different nutritional     compounds.      Fasting (36 hours) creates a catabolic state that is comparable with the catabolic state seen     in acute illness.      This study is a randomized, placebo cross-over study investigating 8 healthy men on 4     separated days (at least 3 weeks between trials).        -  High leucine content drink        -  Low leucine content drink        -  Low leucine content drink + HMB        -  Carbohydrate (isocaloric)      The investigators hypothesize that these nutritional supplements may counteract catabolic     processes in different ways and degrees.   "
110466|NCT01840085|"     To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous     treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple     ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.   "
110467|NCT01840072|"     This randomized trial tests the effect of early blood pressure reduction on major disability     and death among patients with acute ischemic stroke in china.   "
110468|NCT01840059|"     The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a     treatment that lowers the activity of the sympathetic nervous system) is useful in the     management of patients with heart failure with preserved ejection fraction (HF-PEF).   "
110469|NCT01840046|"     Alopecia areata is an autoimmune disease associated with infiltration of cluster of     differentiation 4(CD4 +) and cluster of differentiation 8 (CD8) + cells around the hair     follicles. One of the therapeutic approaches of inflammatory diseases such as alopecia areata     is the induction of tolerance. This tolerance induction can be obtained by stimulating     regulatory T cells (Treg). The low-dose interleukin-2 plays a central role in the     development, expansion, regulation and survival of regulatory T cells CD4 + cluster of     differentiation 25 (CD25) + forkhead box protein 3 (FoxP3). Recently, recombinant interleukin     2 (IL2-R) with low dose showed very promising results in two inflammatory disease (GVHD     vasculitis and cryoglobulinemia secondary to hepatitis C): clinical efficacy, increased     population Treg in the blood and an excellent safety profile. We hypothesized that     administration of IL2-R in patients with severe alopecia areata might allow regrowth via     activation of Treg and thus induce regrowth of the air.   "
110522|NCT01839357|"     A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with     left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to     rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo     image and common clinical outcomes such as bleeding and stroke or thromboembolism.   "
145336|NCT01382056|"     Consumption of a diet containing pulse crops provides flavonoid compounds that will improve     vascular function and glycemic control in individuals with Peripheral Artery Disease.   "
110470|NCT01840033|"     Home parenteral nutrition (HPN) is the reference treatment for anatomic or fonctionnal     chronic intestinal failure. Nutritionnal catheter must follow two rules: low infection rate     and be able to preserve the permeability of the central vein. Today, in europeen guidelines,     two types of central devices are recommended: tunnelled central catheter with cuff and     implanted ports. However, their insertion is not without risk. Since many years, we have seen     a new generation of catheter - peripherally inserted central catheter (PICC line)- which have     many advantage over other central catheter. ESPEN guidelines accept the use of PICC line in     short and moderate-term for HPN, but no prospective study have look for long-term used in     HPN.      The objective of our study is to evaluate in a prospective randomised monocenter study the     no-inferiority of PICC line to tunnelled central catheter with cuff for serious catheter     related-complications such as infection and thrombophlebitis for patient on HPN over 1 month     of duration. The secondary objectives are to: evaluate the number of patients with at least     one serious complications related in 1000 days of used, the rate of minors and majors     complications, number of catheter inserted, the satisfaction of patients and doctors.      The study is held in CHU Nice and will be proposed to hospitalized patients who will need     HPN. After consent, patients will be randomized to receive PICC Line (group A) of nutritional     central catheter with cuff (group B). Echography of vessels will be held at the beginning, 3     months and 12 months. Follow-up will be conduct at regular interval (month 0-1-3-6-9-12). The     duration of follow-up will be of 12 months and the global duration of the study will be 36     months. One major complication will conduct to withdrawal of the study. There will be 55     patients in each group.   "
110471|NCT01840020|"     The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size     and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass     procedure, involves significant changes to the size and function of the stomach and leads to     more rapid gastric emptying. Consequences will be faster absorption and higher peak     concentration of ethanol after surgery than before. There are growing concerns that surgery     for obesity in this way may cause alcohol abuse.      In this study the investigators compare changes in FPM of ethanol following two different     bariatric surgical procedures.   "
110472|NCT01840007|"     In western countries, melanoma represents a major mistake of public health by its frequency,     lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In     other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of     visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6     months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response     rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a     response rate of 10%, and other available treatments don't have a superior efficiency.     Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation     of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement     with these data, several preclinical studies suggested that metformin has antineoplastic     activity. In the case of melanoma, a study published recently has showed that metformin     inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results     in our laboratory (INSERM U895).   "
110473|NCT01839994|"     The purpose of this study is to compare the outcomes of conventionally fractionated conformal     radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or stereotactic     body radiotherapy for intermediate or high-risk prostate cancer patients.   "
110913|NCT01834196|"     This is a clinical pilot study to assess the feasibility of using a swept-source optical     coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature     in patients with existing microvascular disease.   "
110476|NCT01839955|"     This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when     given together with erlotinib hydrochloride and to see how well it works in treating patients     with stage IIIB-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as quinacrine dihydrochloride, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Giving     erlotinib hydrochloride together with quinacrine dihydrochloride may kill more tumor cells   "
110477|NCT01839942|"     For laparoscopic ventral hernia repair, the technique to close the hernia gap is not well     established. Mainly three techniques are currently applied:        -  no closure at all        -  extracorporal suturing of the gap        -  intracorporal suturing of the gap      All three techniques have been applied at our hospital. Patients who received laparoscopic     hernia repair between 2006 and 2011 will be identified from the patient database and will be     contacted by phone to inquire about the outcome and the satisfaction of the surgery.   "
110478|NCT01839929|"     The purpose of this study is to evaluate the efficacy of tacrolimus modified release     formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.   "
110479|NCT01839916|"     This pilot phase II trial studies how well giving donor T cells after donor stem cell     transplant works in treating patients with hematologic malignancies. In a donor stem cell     transplant, the donated stem cells may replace the patient's immune cells and help destroy     any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T     cells (donor lymphocyte infusion) after the transplant may help increase this effect.   "
110480|NCT01839903|"     Emergency Departments (EDs) are a critical component of the U.S. healthcare system, treating     over 119 million patients each year. While EDs have historically neglected tobacco control     efforts, several recent studies have examined the feasibility and efficacy of implementing     tobacco cessation in the ED. Work by our research team and others, has shown that tobacco     treatment is both feasible and effective in the ED setting.      Effective, evidence-based interventions for treating tobacco dependence have also been     codified in the United States Public Health Service guidelines. Even brief interventions     delivered by physicians and other healthcare providers can produce significant increases in     cessation across diverse clinical settings (e.g., outpatient clinics, surgery units, EDs),     and patient groups (cardiac, respiratory, general admissions). However, in clinical practice,     delivery of tobacco interventions is inconsistent at best, particularly in non-primary care     settings.      This translational study uses an existing Emergency Department Information System (EDIS), to     facilitate the identification of smokers and to enhance the provision of smoking cessation     intervention materials and pharmacological adjuncts for patients receiving treatment in the     ED. The EDIS tracks the geographic and chronologic progression of patients through the ED and     contains triage and nursing notes, lab values, radiology reports and links to images, vital     signs, embedded printable discharge instructions, and fax links to primary care provider     (PCP) offices.      Following recruitment of a baseline (care-as-usual) cohort (Step 1), the investigators will     provide training to ED physicians and staff to improve the identification and treatment of     smokers. Following Step 1, the investigators will make adaptations to the EDIS system that     include smoking status tracking, tobacco treatment prompts and medication information panels     for the emergency treating physician, and links to printable discharge instructions,     quit-smoking medication information and referral to a pro-active phone follow-up counseling     for enrolled smokers. A second cohort of participants (Step 2) will be enrolled after     implementation is complete. Contemporaneous with Steps 1 and 2, participant cohorts will be     recruited at a control site (UMass Medical) to control for potential effects of historical     trends. This study represents a comprehensive systems-based translation of empirically     supported tobacco treatment built into a widely used patient tracking platform (MedHost)     maximizing the probability of developing a sustainable tobacco intervention that can be     readily disseminated.      Specific Aims A.1. To test the incremental efficacy of a modified Emergency Department     Information System (EDIS) MedHost, using a multiple-cohort design implemented in 2 steps.     Two recruitment phases (baseline/care as usual and full implementation) will be used to     assess the impact of EDIS enhancements on rates of identification and treatment of ED     patients who smoke. The primary outcome is the difference in six-month abstinence between     those recruited prior to program implementation (Baseline) versus those recruited when the     program is fully implemented (Step 2). H1) Smokers enrolled during Step 2 at RIH will show     significantly greater cessation at month 6 compared Step 1 and control site participants.      A.2. To compare rates of smoker identification, physician intervention and follow up care for     smoking cessation and use of quit-smoking medications among ED patients recruited before and     after EDIS modification. H2) Compared to Step 1 and the control site, Step 2 will show     significantly higher rates of smoker identification, physician intervention and follow-up for     smoking, and use of quit-smoking medications.      A.3. To investigate the effects of the EDIS enhancement on relevant behavioral and     psychological constructs that may act as mediators of smoking behavior change (Mechanisms of     Action), and the relationships of these potential mediators to smoking cessation (e.g.,     perceived risk, nicotine dependence; in Measures section). H3) Participants enrolled during     Step 2 at RIH will show greater changes in posited mediational constructs than those enrolled     in Step 1 and at the control site.      A.4. To examine the incremental costs of implementation of the intervention and to conduct     analyses of marginal cost effectiveness using cost-per-smoker-quit. (This aim is not     hypothesis driven) Exploratory Aim: A.5. To examine ED physician and other health care     providers (HCP) attitudes regarding the utility of the EDIS system for tobacco intervention.     The investigators will conduct interviews with ED physicians and nurses to elicit their     perceptions of the usefulness and helpfulness of the modified EDIS, and its effects on their     perceived self-efficacy and motivation to provide tobacco intervention. The investigators     will also solicit direct feedback on the modified platform and user interface.   "
110481|NCT01839890|"     Study objective is the evaluation of safety and efficacy at 9 months of combination treatment     of bare metal Stent plus Paclitaxel Eluting Balloon vs bare metal stent (conventional     treatment) in patients with acute myocardial infarction with systolic time elevation of less     than 12 hours of evolution.   "
110593|NCT01838421|"     In the context of the study a retrospective data collection of all anaesthesia protocols of     children under the age of 12 which underwent surgery in the Charité - University Medicine     Berlin, Campus Virchow - Klinikum in the years 2011 and 2012 shall be executed. The     correlation of the tracheal tube sizes with the weight, age and height shall be evaluated.     This data collection should serve to reevaluate the already published formulas e.g. (Rettberg     M. et al., 2011).   "
110482|NCT01839877|"     Treatment of patients with colorectal cancer having liver metastases is currently based on     systemic chemotherapy.      Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of     response and secondary resectability, however it is particularly toxic.      Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has     shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up     and reserved for experienced centers.      The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin     associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto     microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2     sessions, and therefore could be more easily generalized.   "
110483|NCT01839864|"     The study aims are to test whether the use of promotoras significantly impacts the health     attitudes, health seeking behaviors, and patient confidence in self-managing health of rural     Hispanic adults who have been diagnosed with metabolic syndrome. Specifically, the study is     designed to address four areas of inquiry: 1) identification of patient attitudes involving:     a) trust in medical providers and in the health care system, b) procedural fairness in     treatment, c) provider and patient communication patterns, d) potential cultural bias in     treatment, and e) healthy lifestyle behavior adoption/maintenance, 2) selected clinical     indicators of metabolic syndrome (blood pressure, height/weight/BMI, blood glucose,     hemoglobin A1c, and cholesterol), 3) the cultural competence of medical providers from the     perspective of both the provider and the patient, and 4) patient self-management confidence     scores.   "
110484|NCT01839851|"     The purpose of this study is to prospectively examine the relation between topical     corticosteroid use and hair cortisol concentration, among patients with moderate persistent     asthma or allergic rhinitis. The investigators hypothesize that patients with asthma or     allergic rhinitis treated with topical corticosteroids (i.e. inhaled corticosteroids (ICS) or     intranasal glucocorticoids (INGC)) have higher levels of hair cortisol after 3 months of     treatment than during the 3 months prior to initiation of treatment.   "
110485|NCT01839838|"     The overall objectives of the study are to establish feasibility and acute side effects of     accelerated partial breast irradiation therapy, along with more long-term side effects and     clinical efficacy of treatment.   "
110486|NCT01839825|"     The objective of the study is to examine the efficacy and safety of QuietCare in a     randomized, open study in elderly subjects living in assisted/ independent living facilities     for 6 months.   "
110487|NCT01839812|"     Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone     results in similar drug levels for all patients and to characterize the relationship between     these drug levels and the innate stress response following infant Cardiopulmonary Bypass     (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly     variable, and that the infant stress response is inversely related to the amount of     dexamethasone measured in the blood. To test this theory the investigators simultaneously     measured blood levels of dexamethasone and cortisol at critical time points during the     perioperative period for infants undergoing CPB for CHD surgery.   "
110488|NCT01839799|"     Determine the relapse-free survival of resected pancreatic cancer patients following two     novel regimens with activity in advanced disease.   "
110489|NCT01839786|"     The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary     hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart     catheterization (RHC) in order to assess whether this non-invasive tool could be used in     pulmonary hypertension diagnosis and monitoring.   "
110490|NCT01839773|"     The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral     paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent     Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.   "
110492|NCT01839747|"     This research study is a Pilot study (a small preliminary study to assess the feasibility of     a larger, more in depth study involving a new test or procedure) and is being done to     evaluate the feasibility and accuracy of PET/MRI in the evaluation of cancer. PET/MRI is a     FDA approved technology that is currently being studied to assess its accuracy and utility in     the diagnosis and management of a variety of diseases and patient populations. The focus of     this particular study will be to compare the performance of PET/MRI in its ability to detect     and characterize cancerous tumors using positron emission topography and computed tomography     (PET/CT) as a reference standard.   "
110493|NCT01839734|"     The use of lubiprostone will decrease the levels of immune activation in HIV-infected     subjects with incomplete CD4+ T-cell recovery with antiretroviral therapy (ART).        -  Lubiprostone will decrease levels of translocated gut microbial products in HIV-infected          subjects with incomplete CD4+ T-cell recovery with ART.        -  The decrease in levels of translocated gut microbial products will be associated with a          decline in the levels of immune activation in HIV-infected subjects with incomplete CD4+          T-cell recovery with ART.   "
110494|NCT01839721|"     In this double-blinded randomized clinical trial study, investigators assessed probiotic used     to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated     for pelvic cancer.   "
110495|NCT01839708|"     Mothers in Motion will draw on the successes of the pilot intervention of the same name and     will promote healthy lifestyle behavior changes (eating more fruits and vegetables,     increasing physical activity, dealing with stress) in low-income WIC mothers of young     children. The intervention group's weight change (difference between the initial enrollment     and 3 months post intervention) will differ from the control group's weight change by an     average of at least 2.8 pounds.   "
110496|NCT01839695|"     The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms     of the descending thoracic aorta (DTA) in patients who require coverage of the left     subclavian artery (LSA).The study is intended to assess safety and performance of the device     acutely and at 30 days.   "
145358|NCT01380808|"     The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy     capecitabine.   "
110498|NCT01839669|"     Pes planovalgus, also called flat foot, is a common foot deformity characterized by a     flattening of the foot's longitudinal arch and is accompanied by a dysfunction of the     posterior tibial tendon (posterior tibial tendon dysfunction or PTTD). Early stages of     this pathology are thought to be treated with non-surgical therapy options like foot orthoses     (relief of tendon stress by mechanical unloading of the arch), strengthening exercises or     basic physiotherapeutic measures. Recent literature clearly states the urgent need for high     quality studies to evaluate the proposed non-surgical treatments (Bowring 2009, 2010). There     is only one high quality study available that shows benefits of orthoses therapy and exercise     (Kulig 2009). No study to date evaluated functional changes pre-post in dynamic movement     pattern like gait or stair climbing. The widespread use of several non-surgical treatment     strategies lead to extensive financial expenses of the health care system. An optimized     therapeutic strategy could eventually lead to more efficient health care investments. The     presented proposal addresses this latest knowledge and aims to analyse non-surgical treatment     strategies to Cure Pes Planovalgus associated Complaints (CurePPaC) in the CurePPaC Study.   "
110499|NCT01839656|"     The primary objective is to examine the clinical efficacy of multiple doses of nusinersen     (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular     Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of     multiple doses of nusinersen administered intrathecally to participants with infantile-onset     SMA and to examine the cerebral spinal fluid (CSF) and plasma Pharmacokinetics (PK) of     multiple doses of nusinersen administered intrathecally to participants with infantile-onset     SMA.   "
110500|NCT01839643|"     In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a     local route (vaginal) and observe the effect on follicular development. This study will     include 3 menstrual cycles, beginning with one menstrual control cycle, following by one     menstrual cycle with meloxicam ring administration and finishing with another control     menstrual cycle.      Meloxicam will be administered via a vaginal ring in two doses of 2.4 g and 3.0 g/ ring     during one menstrual cycle. Safety study of absorption will be assessed. Also the     investigators will study the effect on follicular development and if it maintains ovarian     cyclicity, as well as shown in recent study with oral administration.   "
110501|NCT01839630|"     This study is to obtain the characteristics and treatment pattern of the unresectable HCC     patients who are candidates for systemic therapy and in whom a decision to treat with     sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd     TACE procedure) has been made under real-life practice conditions.this study will also     conclude the safety and effectiveness of combination in uHCC patients.   "
110502|NCT01839617|"     The aim of this study is to find which is the best nutritional strategy in cancer patients     undergoing abdominal surgery regarding postoperative complications.   "
110503|NCT01839604|"     This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability,     pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with     advanced/metastatic hepatocellular carcinoma.   "
110519|NCT01839396|"     The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's     Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced,     levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled     with medication.   "
110529|NCT01839266|"     Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be     rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and     therapeutic modalities, it is still one of the important causes of hospital mortality.     Previous several reports have described the variable outcome of patients with PE with     reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock)     and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies     from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV     unfractionated heparin. We conducted this study to determine the outcome, risk factors,     clinical characteristics and demographics of patients with acute PE and to identify possible     demographic and clinical factors associated with prognosis.   "
110504|NCT01839591|"     In severe bronchial asthma the mechanism of inflammation and bronchospasm is complex and     still not clarified. The smooth muscle cells play an important role from the mechanical point     of view, as a culmination of neurogenic stimuli and inflammatory cytokines that determine as     final effect the bronchospasm and over time a hypertrophy of the muscular coat. There are     some other hypothesis that the smooth muscle cells may play a role as central regulator of     chemical mediators that cause bronchospasm and inflammation, although there are currently no     firm conclusions 2 According to other studies3,the nerve receptors TRANSIENT RECEPTOR     POTENTIAL VANILLOID TYPE 1 have a great importance in the complex mechanism of airway     inflammation too. (There are at least 4)      These receptors would intervene according to the following mechanism:        1. Irritants on the bronchial mucosa stimulate the TRANSIENT RECEPTOR POTENTIAL VANILLOID          TYPE 1 present on afferent endings of sensory fibers, unmyelinated C (chemiosensitive          neurons)        2. On the same afferent axon acting factors with the activation effect (lowering the          activation threshold, increase the expression, promote the translocation of TRPV1          receptor on the membrane). Among these factors the neurotrophins of which the most          important NERVE GROWTH FACTOR (NGF)        3. The activation of TRPV1 (through release of Ca2 + +) determines two efferent responses:             1. CENTRALLY-MEDIATED             2. LOCAL AXON Reflex      Investigators hypothesized that BT may have a strong influence on the destruction of nerve     receptors TRPV1 and unmyelinated nerve fibers located in the mucosa going to stop reflections     both central and local authorities responsible for the activation of bronchospasm. In support     of this hypothesis, there are some anatomical studies4, which show that these receptors are     more numerous at the level of main bronchi which are the main target of BT. Please note in     this context that it is already known that in thermoablations commonly used in cardiology it     is used a radio frequency with development of heat controlled to 65 °, as in the BT, able to     interrupt the circuit nervous responsible for the activation of the circuit causing the     abnormal 'arrhythmia.   "
110505|NCT01839578|"     Sepsis is responsible for 50% of all acute kidney injury (AKI) in intensive care units     (ICUs), contributing greatly to multiple organ dysfunction syndrome (MODS). Special types of     continuous renal replacement therapies (CRRT) have been proposed as adjuvant therapies for     septic shock due to their ability to remove middle molecular weight molecules such as     inflammatory mediators involved in MODS pathophysiology. These therapies are called     extracorporeal  blood purification  therapies.      When CRRT is used, an anticoagulation is required to prevent clotting of the extracorporeal     circuit, possibly causing bleeding in selected patients. Many anticoagulation strategies have     been proposed and the most commonly used in 2013 is still unfractionated heparin. Regional     citrate anticoagulation (RCA) is an interesting alternative as it dramatically decreases the     bleeding risk.      The investigators hypothesize that the use of citrate with Super High Flux Continuous     Veno-Venus Hemodialysis (SHF-CVVHD) would be highly beneficial over time by preserving the     filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore     sizes (protein cake)), as compared to heparin. Consequently, higher clearances of the     inflammatory mediators could be maintained over time with citrate as compared to heparin     anticoagulation. In other words, for the same duration of filter use, middle molecular weight     molecules and cytokines clearances would be greater with citrate as compared to heparin. To     test this hypothesis, the investigators will perform a clinical randomized controlled trial     which aim would be to compare middle molecular weight molecules and cytokines clearances in     SHF-CVVHD using RCA versus systemic heparin anticoagulation in septic patients with AKI.   "
110506|NCT01839565|"     The absence of methodologically, prospectively and retrospectively collected information on     the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a     multicenter approach. Using a registry to get more information about the effectiveness and     possible benefits or complications during the surgery and during the post-operative treatment     is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.   "
145359|NCT01380795|"     The knowledge concerning the biology of the human tumors do not stop widening, in particular     concerning the molecular mechanisms at the origin of the process of carcinogenesis and its     ability to become perpetual. The identification and the increasing knowledge of these     abnormalities allowed during these last years the development of therapeutic strategies     targeting specifically the molecular pathways involved in the carcinogenesis. It quickly lead     to numerous therapeutic successes in association with conventional chemotherapy, allowing a     better individualization of the treatment according to the biological characteristics of the     tumor of the patient.      However such therapeutics are effective only if the patients carries specific genomic     mutations making necessary the systematic research for one kind of mutation.      The problem is that currently the mutational status is frequently made on the tissue     resulting from the initial tumor biopsy, and as it is not excluded that the evolution of the     biology of the metastasis reports a different genomic status, the only theoretical solution     is then to make biopsy systematically on metastasis, what is not always technically possible.     The problem still complicates when the investigators know that the biology of the tumor may     evolve in time, particularly under treatment, with appearance of chemotherapy resistant     clones. The monitoring of the genomic status of the tumor thus appears to be a crucial stake     in the next years in cancer research as far as the efficiency of numerous therapeutic     targeted put at the disposal of the clinician, depends on it largely. The repeated access to     tumor tissue, during the follow-up of the patient in treatment, seems from then on     indispensable to guide prematurely the therapeutics, in particular by stopping a targeted     therapeutics which the investigators know that it is not any more going to be effective, and     so avoiding exposing the patient to useless toxicity of a treatment often extremely     expensive, and of which usage should have to be reserved to patient who could respond to it.      The access to the circulating tumor cells in the blood of patients is a repeatable, not     invasive technique (blood test) and henceforth accessible thanks to a technique using a     magnetic sorting of the tumor cells selected by an antibody directed against the tumor     antigen EpCAM. This new technology (CellSearch, Veridex system) totally standardized and     automated, allows from a total sample of blood of the patient, to determine the quantity of     circulating tumor cells (CTC).The number of CTC seems to constitute in recent studies, a     powerful prognosis tool at the moment diagnosis, but also during treatment, according to its     decrease or not under chemotherapy. In United States, the Food and Drug Administration (FDA)     recently approved the use of this system for the quantification of the CTCs in the care of     the patients affected by breast, colon, and prostate cancer. The CellSearch system will     probably become in the future years an indispensable tool to help the clinicians to encircle     better the prognosis of their patient. This technology already allows to realize besides a     quantification, the isolation of viable CTCs, from which the genetic material can be     extracted, amplified thus potentially analyzed. The investigators thus see all the interest     which such a device can represent in the non invasive monitoring of the patients under     treatment targeting molecular abnormality susceptible to evolve in time. The investigators     thus propose to study thanks to the system CellSearch the feasibility of the research for the     mutation of K-Ras and EGFR in the CTC of patients carriers of a metastatic non small cells     bronchial carcinoma.      Secondly, the investigators research will be interested in the possible conflicts existing     between the primitive tumor and the CTCs for the various popular mutations. In case of     feasibility of the method, and the good initial concordance between the genomic status of the     CTCs and that of the tumor, the investigators shall describe the genomic evolution under     treatment monitoring the CTCs of the patients under targeted therapeutics. The investigators     shall describe then if the premature observation of modification precedes the appearance of     an effective resistance in treatments.   "
110509|NCT01839526|"     No investigational drug will be administered in this study for the treatment of Fabry     disease.      This will be a multicenter, multinational, non-treatment, cross-sectional study of young male     patients with Fabry disease who have not yet initiated interventional treatment for this     disease. The study will consist of a screening visit(s), a clinical investigation visit(s),     and a follow-up phone contact.      The objectives of the study are:        -  To document renal function and other Fabry disease manifestations across age in          treatment-naïve, young male patients with Fabry disease.        -  To provide a reference group for comparison with interventional clinical trials of Fabry          disease.      The duration of each patient's participation in the study, inclusive of the screening visit     and follow-up phone contact, will be approximately 12 weeks.   "
110510|NCT01839513|"     The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the     prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower     limb orthopedic surgery on desflurane/remifentanil general anesthesia.   "
110511|NCT01839500|"     This prospective, multi-center, non-interventional study will evaluate the efficacy and     safety of trastuzumab in routine clinical practice in Chinese participants with gastric or     gastro-oesophageal cancer. The study will be conducted in 5 cohorts and eligible participants     will be enrolled and assigned to the various cohorts according to human epidermal growth     factor receptor 2 (HER2) status, disease stage and treatment with trastuzumab according to     physician's decision. Treatment patterns and clinical outcomes in participants with gastric     cancer in China will be evaluated. The total study duration is 60 months.   "
110512|NCT01839487|"     To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG)     to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer.      The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization,     PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a     second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).   "
110513|NCT01839474|"     The purpose of this study is to determine if the use of a continuous positive airway pressure     (CPAP) machine (a device that blows air into the lungs) decreases the chance of a child dying     from difficulty breathing.   "
110514|NCT01839461|"     The purpose of this research study is to identify factors and genes (the DNA material that     determines the makeup of the human body) that may be associated with how children respond to     pain medication. Morphine is a pain medication commonly prescribed after this surgery during     the hospital stay. The investigators want to study factors that may be associated with pain     sensitivity, morphine requirement after surgery and side-effects from morphine. The     investigators expect that the information obtained in this research study will help to     develop effective, safer, and tailored treatment options in the future.   "
110530|NCT01839253|"     For those who receive hypotensive anesthesia in orthognathic surgeries, the investigators     premedicate with anti-hypertensive agent so that it decreases the occurence of tachycardia     and the rebound hypertension due to hypotensive anesthesia, enabling us to compare     hemodynamic stability and reduction of anesthetic agents during the operation.   "
110520|NCT01839383|"     The investigators enrolled 90 patients on maintenance hemodialysis with dialytic vintage ≥12     months, iPTH 150-300pg/ml and serum calcium<2.5mmol/L. Patients were randomized to three     groups with different dialysate calcium concentration , 1.25 mmol/L(DCa1.25),     1.5mmol/L(DCa1.5) and 1.75 mmol/L(DCa1.75) for 24 months respectively. Hemodialysis was     performed for 4 hours three times weekly. Serum total calcium(tCa), ionized     calcium(iCa),intact parathyroid hormone(iPTH)and phosphorus (P) levels were recorded before     and after the study and single dialysis session in every patient. iCa and P levels were     measured in spent dialysate.Bone density, bone-specific alkaline phosphatase(BAP),     osteoprotegerin(OPG)、β-crosslaps、total Procollagen Type I Intact Propeptide (P1NP）and     vascular calcification were measured in every patient periodically. vascular calcification     including aortic arch calcification, abdominal aorta calcification and coronary artery     calcification were measured by chest radiography, lateral lumbar radiographs and coronary     artery computer tomography (CT) respectively. The primary endpoints included death,     cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke),     newly nontraumatic bone fracture, secondary parathyroidism uncontrolled by medicine and     valvular or vascular calcification. The secondary endpoint were admission or emergency     observation.   "
110521|NCT01839370|"     In this study, a closed-loop Adaptive Insulin Meal Supervisor system (AIMS) utilizing     continuous glucose monitoring (CGM), a subcutaneous insulin pump and standard pramlintide     therapy will be applied in individuals with type 1 diabetes. Pramlintide, a drug well     recognized to help control hyperglycemia with meals, will be evaluated in both closed loop     and open loop control. It is expected that the closed loop control condition with pramlintide     will improve glycemia, thus combining better control with enhanced safety. In a recent pilot     study, the investigators started testing this concept and collected data showing that in     order to be successful such strategy must have a controller equipped with the ability to     optimize the configuration and timing of meal boluses with concomitant administration of     pramlintide. Our preliminary data and review of previously unavailable individual data from a     German study indicate a large individual variability in the timing of the appearance of meal     insulin needs. Thus, for both adequate safety and efficacy of meal insulin on pramlintide,     the investigators have developed a new closed-loop controller that accounts for the     variability in the individual responses to a meal and meal delays, the Adaptive Insulin Meal     Supervisor system (AIMS). In this study, the performance of a combination between the AIMS     system and a standard pramlintide treatment will be tested versus the standard pramlintide     treatment alone.   "
110523|NCT01839344|"     The purpose of this study is to measure the effect of quercetin on glucose tolerance and     postprandial endothelial function in comparison to placebo and Acarbose in participants with     Type 2 Diabetes.      Primary Hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a 100g     maltose tolerance test (MTT) will result in a decrease in postprandial blood glucose at 60     minutes compared to placebo. Acarbose (100mg oral), a pharmaceutical alpha-glucosidase     inhibitor, will serve as a positive control.      Secondary Hypothesis: We hypothesize that administration of quercetin (2g oral) will reduce     the Area Under the Glucose Curve (AUC) for the 2 hours following a 100g MTT compared to     placebo. AUC is hypothesized to be comparable between quercetin and Acarbose.      Tertiary hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a     100g MTT will result in a smaller reduction in flow mediated dilation (FMD) measured as an     increase in Reactive Hyperemia Index (RHI) at 90 minutes compared to placebo.   "
110524|NCT01839331|"     This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in     Adults with pain due to osteoarthritis of the knee.   "
110525|NCT01839318|"     The purpose of this study was to compare three CE-marked daily disposable contact lenses for     tear film stability as measured by pre-lens non-invasive keratograph break up time (PL     NIK-BUT). Secondarily, contact lens surface wettability was assessed.   "
110526|NCT01839305|"     Fibromyalgia Syndrome (FS) is one condition that most affects functional performance,     especially in women, due to alterations in the entire musculoskeletal system. Given that,     Physical Therapy (PT) studies the human movement and its dysfunctions, and that FS, because     of its complex chronic characteristic, impairs the affected individual's activities causing     movement disorders, a PT professional must be part of the multidisciplinary team involved in     the FS treatment. Nonetheless, as explained in the present proposal, several aspects still     need clarification related to the PT role in this syndrome. Particularly, studies that     analyze the biomechanical, sensorial and cardiorespiratory adaptations in individuals who     undergo PT intervention still lack; those studies would contribute with scientific evidence     to the clinical practice. According to recent systematic reviews, one of the most used     therapies with positive effects on FS subjects is the hydrotherapy, which combines exercises     and the water relaxing effects. Other alternative treatments have also been searched, in an     attempt to decrease the painful picture presented, as the FS etiology and pathophysiology are     not well known. The aim of this study is to evaluate the efficacy of different physical     therapy resources in the FS, in two subprojects. The first will verify if hydrotherapy is     effective in modifying movement variables (scapular kinematics and electromyography) and     autonomic modulation. Other variables, such as pain level and quality of life in women with     FS, will also be analyzed. The second study will evaluate the efficacy of the Shiatsu massage     on pain, sleep quality, balance and quality of life of subjects with FS.   "
110527|NCT01839292|"     Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a     common complication of uncovered SEMSs. However, they have revealed a high incidence of stent     migration in patients with unresectable malignant gastric outlet obstruction (GOO). A     conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth.     The aims of this study were to evaluate the clinical outcomes of newly designed conformable     covered and uncovered SEMS for palliation of malignant GOO.   "
110528|NCT01839279|"     This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study     with a nested crossover comparison to define the ECG effects of tizanidine compared to     placebo and the positive control, moxifloxacin, in healthy men and women. The study will be     conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the     protocol.   "
118995|NCT01728376|"     The intent of this study is to describe the safety and efficacy of daptomycin versus standard     of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by     Staphylococcus aureus (S. aureus).   "
110531|NCT01839240|"     This phase I trial studies the side effects and best dose of azacitidine when given together     with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute     myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, cytarabine, and     mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. Azacitidine may also help cytarabine     and mitoxantrone hydrochloride work better by making the cancer cells more sensitive to the     drugs   "
110532|NCT01839227|"     Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients     undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides     information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD     after general surgery has been lacking. Especially, the prone position is used primarily for     surgical access to the posterior spine, if there is any significant lowering of the legs or     tilt of the entire table, venous returns may be decrease or augmented accordingly. The     purpose of this study was to examine the relationship between POCD and intra-operative     cerebral oxygen saturation after spine surgery in elderly patients.   "
110533|NCT01839214|"     This study will examine the safety and efficacy in subjects with mild to moderate ulcerative     colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and     other assessments.   "
111717|NCT01823900|"     This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug     of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and     Olmesartan (reference formulation) for single dose in healthy volunteers   "
110534|NCT01839201|"     Hypothesis: By employing suggestions before the induction of narcosis dreams may be evoked     and their content may be directed.      The main goal of suggestive techniques in the perioperative phase is to turn the content of     dreams toward a favourable direction that is considered a pleasant event by the patient. So     far little attention has been paid to the administration of perioperative psychological     methods that may meet these requirements.      Along these lines, in the present study we intended to assess whether dream recalls can be     influenced by two different psychological methods administered in the preoperative setting   "
110535|NCT01839188|"     To evaluate the immune response and the safety of a primary series schedule that includes     V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age      Primary objectives        -  To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B one          month after completion of the mixed schedule        -  To demonstrate that the mixed schedule induces acceptable responses for Hib one month          after completion of the mixed schedule      Secondary objectives        -  To describe the antibody response to all PR5I antigens one month after completion of the          mixed schedule        -  To describe the antibody response to meningococcal serogroup C (MenC) conjugate vaccine          one month after the second dose of MenC vaccine        -  To describe the safety profile after each dose of study vaccines administered   "
110536|NCT01839175|"     Primary Series Primary objectives        -  To demonstrate that the concomitant administration of the hexavalent vaccine with a          meningococcal serogroup C conjugate vaccine is non inferior to the administration of the          hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate          for hepatitis B one month after the third dose of the hexavalent vaccine        -  To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent          vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one          month after the second dose of MenC      Booster Primary objectives      - To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a     meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of     age or given separately.   "
110537|NCT01839162|"     During percutaneous coronary interventions standard operator radio-protection is generally     ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded     glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a     bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield     on the patient, the radiation dose adsorbed by operators was significantly reduced even if     was higher compared to transfemoral approach. No studies evaluated the effect of both     adjunctive shields placed in the same patient.      Aim of our randomized study is to evaluate if the combination of a shield drape on the     patient right arm and a pelvic lead shield during transradial percutaneous coronary     procedures may reduce the radiation dose adsorbed by operators compared to the use of only     one shield or none.      All patients who underwent to percutaneous coronary diagnostic or interventional procedures     will be enrolled in this randomized study. Eligible patients will be randomized (using a     computer generated randomization sequence) in 4 groups:        1. use of a pelvic shield drape        2. use of a shield drape on the patient right arm        3. use of a pelvic shield drape and a shield drape on the patient right arm        4. Any adjunctive shield drape (only standard radio-protection) For each group a further          internal randomization will be performed in order to compare the right or left radial          transradial approach.      Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax     level outside the lead apron. Since December 2013 the operators are equipped with a further     dosimeter at head level.      Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by     operators and detected by the electronic dosimeters.      Secondary end-point are:        1. Radiation dose adsorbed by operators according to the radial access (right versus left)        2. Radiation dose adsorbed by the patients        3. Radiation dose adsorbed at head level.   "
110538|NCT01839149|"     This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high     frequency episodic migraine and chronic migraine.   "
110539|NCT01839136|"     Background: The cost for the treatment of infertility are limiting for the health care     access, particularly if we consider that the success rate per cycle is approximately 35%.     Alternative regimens for controlled ovarian stimulation (COS)have been described in the     medical literature, that lead to a lower cost, fewer injections and less risk of adverse     events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report     excellent results with less manipulation as possible, which reduces the cost of laboratory of     human and ethically be considered less complicated once fertilization occurs in the uterus     and not in vitro.      Objectives: The main objective is to compare the reproductive outcomes between intrauterine     transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the average     number of eggs that are raised when using an EOC reduced cost.      Methods: This study will be conducted in the area of Human Reproduction, Department of     Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study     with random allocation of the participants in a 1:1 ratio, and we plan to include 100     participants. All participants will undergo an EOC reduced cost. We will compare the chance     of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman allocated     and to estimate the number of oocytes retrieved considering all participants.   "
110540|NCT01839123|"     The purpose of the study is to evaluate residual limb circulation and skin health associated     with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will     be compared to a vacuum prosthetic socket.   "
118996|NCT01728363|"     Multiple center, open-label, PK study   "
110541|NCT01839110|"     This study is looking to see if giving ranolazine to subjects on stable pulmonary     hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) would     improve their outcome. This study is accompanied by a baseline comparison of the metabolic     profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.   "
110542|NCT01839097|"     The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for     belinostat when combined with CHOP regimen and establish the recommended belinostat dose for     the Phase 3 study.   "
110543|NCT01839084|"     Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a     nephroprotection after partial nephrectomy.   "
110544|NCT01839071|"     The purpose of this study is to investigate if patients with coronary heart disease have     higher risk to develop diabetes mellitus among the following two years.      The examination of biomarkers taken from blood and fat issue shall provide which factors     could be responsible for development of diabetes mellitus.   "
110558|NCT01838889|"     This study is an exploratory randomized controlled trial (RCT) of a group psychological     intervention for postnatal depression in British mother's of south Asian origin. The aim is     to evaluate the efficacy of a group psychological intervention (PHP) based on the principles     of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is     that depressed British women of South Asian origin receiving the group intervention will show     significant improvements in terms of severity of depression as compared to the treatment as     usual (TAU) control group.   "
110545|NCT01839058|"     Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly     understood. Some evidence suggests it may be related to sustained esophageal contractions     (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a     trigger for SECs and results in shortening of the esophagus. In this study, the investigators     plan to prospectively evaluate esophageal shortening responses to acid in a group of patients     with NCCP compared to controls. The investigators will use high resolution esophageal     manometry coupled with acid infusion to evaluate shortening. The investigators hypothesize     that at least a subset of patients with NCCP will have an exaggerated esophageal shortening     response to acid which correlates with symptom production. If our hypothesis proves true,     this may lead to a future therapeutic target in the treatment of these patients.   "
110546|NCT01839045|"     The major purpose of this study is to evaluate a laboratory developed test that measures     multiple breast cancer-specific biomarker proteins in your blood samples. The biomarker     results along with your personal medical profile will be evaluated to determine your risk for     the presence of a malignancy in the breast as compared to your breast evaluation assessment     conducted by your physician.   "
110547|NCT01839032|"     Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and     NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non     change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles     during RT(66 Gy/6.5 w).   "
110548|NCT01839019|"     The purpose of the study is to evaluate the safety and tolerability of escalating single     doses of ODM-102 in healthy volunteers   "
110549|NCT01839006|"     The purpose of this study is to assess the clinical significance of supranormal differential     renal function (DRF) in the recovery of unilateral hydronephrosis (HN) after surgery,     pediatric patients who underwent pyeloplasty for ureteropelvic junction obstruction (UPJO)     who showed supranormal DRF (> 55%) in the DTPA renography will be analyzed.   "
110550|NCT01838993|"     We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately     before induction.   "
110551|NCT01838980|"     Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby     integrating colon cleansing, screening and treatment into one procedure. The device creates     turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the     system.   "
110552|NCT01838967|"     The investigators investigate the potential pharmacokinetic drug-drug interaction between     Cilnidipine 10 mg and Valsartan 160 mg in healthy male volunteers who receive Cilnidipine 10     mg alone, Valsartan 160 mg , and both together in a 3 period repeatedly.   "
110553|NCT01838954|"     Due to constant strain the joints of the hands are frequently affected by osteoarthritis     (OA).      Short-wave diathermy (SWD) is a form of electromagnetic therapy, which causes movement of     ions, distortion of molecules, and creation of eddy currents and as a result heat is produced     in deep tissue. Its claimed mechanism of action includes inducing an anti-inflammatory     response, reducing joint stiffness, stimulating connective tissue repair, and reducing muscle     spasm and pain.      Since the available studies were performed to study the large weight-bearing joints only,     there is a lack in scientific evidence for the efficacy of SWD in hand OA.      The aim of this randomized, double blind, placebo-controlled study is to evaluate the effect     of SWD on:      joint function in patients with hand OA. joint pain in patients with hand OA. grip strength     in patients with hand OA. quality of live in patients with hand OA.   "
110554|NCT01838941|"     The PBD are a rare group of inherited disorders due to the failure to form functional     cellular peroxisomes. Most patients have progressive hearing and visual loss, leading to     deafness and blindness, as well as neurological deterioration. There are no therapies for     this disorder. A misfolded protein with residual function, PEX1-Gly843Asp, represents one     third of all mutant alleles. Using patient cell lines with this mutation, we reported the     recovery of peroxisome functions by treatment with Betaine, acting as a nonspecific chemical     chaperone for the misfolded PEX1 protein. Betaine, or trimethylglycine, is a Health Canada     and FDA approved orphan drug for the treatment of homocystinuria and is used by us safely and     regularly in genetic medicine. We will perform a 6 month pilot study with 12 patients to test     the hypothesis that Betaine, at recommended doses, can recover peroxisome biochemical     functions in blood.   "
110566|NCT01838772|"     The purpose of this study is to assess the effectiveness and tolerability of hepatitis C     virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia     through a pilot model of care for treatment of HCV in resource-limited settings.   "
110567|NCT01838759|"     We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of     hyponatremia   "
138251|NCT01475162|"     This trial designed to evaluate the toxicity and efficacy of tocilizumab in the treatment of     steroid refractory acute Graft versus host disease (GVHD).   "
110555|NCT01838928|"     Background: The use of ultrasound in regional anesthesia enables a reduction in the local     anesthetic volume. The present study aimed to determine the minimum effective concentration     (EC50 and EC95) of bupivacaine for axillary brachial plexus block (ABPB). Methods: Following     approval by the Research Ethics Committee, patients with a physical condition of I or II     according to the American Society of Anesthesiologists, between 21 and 65 years of age were     recruited and subjected to elective surgery of the hand and ABPB. The concentration of the     anesthetic was determined using a step-up/step-down method and was based on the outcome of     the preceding block.   "
110556|NCT01838915|"     A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue     (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier,     changes in gut microbiota, increased bacterial translocation and persistent immune     activation, changes that are not restored after the initiation of antiretroviral therapy. The     investigators hypothesize than an intervention targetting the enterocyte barrier and the gut     microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and     improve markers of bacterial translocation, inflammation, immune activation and endothelial     dysfunction.   "
110557|NCT01838902|"     In this study, the investigators are interested to know if lower doses of Primaquine together     with dihydroartemisinin-piperaquine can produce a similar effect of clearing both sexual and     asexual parasites in asymptomatic carriers compared to the recommended dose of primaquine but     with a decreased risk of haemolysis.      Children (> 1 year) and adults with normal Glucose-6-phosphate dehydrogenase enzyme levels     but with asexual Plasmodium falciparum parasites on the day of screening will be invited to     take part in this study.   "
110559|NCT01838876|"     The objective of this study is to evaluate the long-term safety and tolerability of     cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major     Depressive Disorder (MDD).   "
146441|NCT01367509|"     This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in     patients with mild, moderate, or severe renal impairment who do not require hemodialysis.   "
110560|NCT01838863|"     Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely     injured trauma patients are found to be coagulopathic and forty percent of the mortality     following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy.     It has been established that early administration of fresh frozen plasma decreases mortality     following severe injury, replacing lost coagulation factors, improving the coagulopathy and     restoring blood volume. This study will determine if giving plasma to severely injured trauma     patients during ambulance transport versus after arrival to the hospital will help reduce     hemorrhage, thus decreasing both total blood product administration and mortality.   "
110561|NCT01838850|"     CS-8635 combines three widely prescribed antihypertensive medications, olmesartan     medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The     purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635     compared with dual therapy in Korean patients with hypertension not controlled with dual     fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in this     study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ; Double     blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching placebo     vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label extension     period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg (CS8635     20/5/12.5mg).   "
110562|NCT01838824|"     This pilot study will document the efficacy of a behavioral intervention for Processing Speed     (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been     successful used in the aging population in several studies. This study will (1) apply a     treatment protocol for PS impairments, well-validated in aging, to persons with MS with     impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess     the effectiveness of the intervention utilizing global measures of daily life, including an     objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in     that it will be the first to evaluate the efficacy of a highly-manualized structured     behavioral treatment for processing speed deficits in persons with MS utilizing the optimal     methodology for carrying out such studies, a randomized clinical trial. Given the prevalence     of PS deficits in the MS population and the significant impact such deficits have on everyday     functioning, public safety, and overall quality of life, the identification of an effective     intervention for PS deficits in MS could have a profound impact on the population and society     as a whole.   "
110563|NCT01838811|"     This pilot study will document the efficacy of a behavioral intervention for Processing Speed     (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been     successful used in the aging population in several studies. This study will (1) apply a     treatment protocol for PS impairments, well-validated in aging, to persons with TBI with     impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess     the effectiveness of the intervention utilizing global measures of daily life, including an     objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in     that it will be the first to evaluate the efficacy of a highly-manualized structured     behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal     methodology for carrying out such studies, a randomized clinical trial. Given the prevalence     of PS deficits in the TBI population and the significant impact such deficits have on     everyday functioning, public safety, and overall quality of life, the identification of an     effective intervention for PS deficits in TBI could have a profound impact on the population     and society as a whole.   "
110564|NCT01838798|"     This is a prospective, single-center, pilot, cohort study. The first phase of this study is     observational and the usual care of patients is maintained during the ICU stay, except for an     interview with a psychologist preceding patient discharge. A phone interview at 2 months and     a visit with a psychologist at four months after ICU discharge are specific to the study.      The main objective of this study is to make a first estimate of the percentage of patients     (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence /     absence of cognitive impairment will be determined by the D2 test.   "
110565|NCT01838785|"     A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years     of age may be eligible for this study. Candidates are screened with a medical history and     physical examination, and blood test.   "
110568|NCT01838746|"     Young patients requiring myocardial revascularization are generally considered at low     operative risk, but data on their immediate and late outcome are scarce. The decision-making     process in these young patients is complicated by the potentially aggressive nature of     premature coronary artery disease and their likely long expectancy of life, which expose them     to a significantly higher risk of recurrent coronary events as well as the need of repeat     revascularization. The lack of data on long-term outcome as well as on operative details (in     particular, on the use of arterial grafts) and peri- and postoperative medication prevent any     conclusive results on the durability either of coronary artery bypass grafting (CABG) or of     percutaneous coronary intervention (PCI) in these young patients. Furthermore, recent     advances in stents technology as well in peri- and postoperative medical treatment indicate     the need a comparative study to define the baseline characteristics of patients aged < 50     years undergoing either PCI or CABG and to evaluate their current immediate and late outcome.   "
110578|NCT01838616|"     This was a clinical effectiveness trial designed to compare the effectiveness, safety, and     tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone     prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with a     neuropathic pain component.      Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol     and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus     oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics     with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the     neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.   "
110569|NCT01838733|"     Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The     definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the     association between desaturations and perioperative outcome, and the mechanistic explanations     of cerebral desaturations remain unexamined. This study seeks to identify the true incidence     and magnitude of cerebral desaturations in high-risk non-cardiac surgical patients and the     association between desaturations and perioperative outcome.      The investigators will attempt to determine the following (1) The proper definition,     incidence and severity of decreased cerebral saturation (rSO2) in high-risk non-cardiac     surgical patients (2) the mechanisms surrounding decreases in rSO2 by correlating it with     alterations in physiologic parameters (such as blood pressure, cardiac output, hemoglobin     concentration, and carbon dioxide levels) and (3) to correlate the incidence and severity of     decreased rSO2 with relevant perioperative.      The investigators will also analyze a panel of inflammatory biomarkers to determine if these     biomarkers have the ability to predict postoperative complications.      The investigators will study 200 high-risk patients undergoing high-risk non-cardiac surgery.     The investigators will determine the incidence and severity of decreases in rSO2, the     associated factors with the occurrence of decreased rSO2, and the relationship between     decreases in rSO2 and adverse perioperative outcome with a composite of well defined     perioperative complications such as death, myocardial infarction, cerebrovascular accident,     acute kidney injury, delirium, postoperative infections, and the need for mechanical     ventilation.   "
110570|NCT01838720|"     To evaluate the feasibility and efﬁciency of zero ischemia laparoscopic radio frequency     ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional     laparoscopic partial nephrectomy.   "
110571|NCT01838707|"     we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL +     Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and     mobilization maneuvers.   "
110572|NCT01838694|"     The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4     weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.   "
110573|NCT01838681|"     To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to     an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).   "
110575|NCT01838655|"     Background:      - Oculocutaneous albinism, type 1B (OCA1B) is a genetic disease caused by problems in the     gene that makes tyrosine. Tyrosine is an amino acid needed to produce pigment in the skin,     hair, and eyes. People with OCA1B have pale skin, white hair, and light-colored eyes. Pigment     in the back of the eye helps vision, so people with OCA-1B often have visual problems.     Researchers want to see if a drug called nitisinone can help improve eye pigmentation and     vision in people with OCA1B. Nitisinone is approved for treating a related genetic disease     that causes problems with tyrosine, so it may help people with OCA1B.      Objectives:      - To see if nitisinone can help improve eye pigmentation and vision in people with OCA1B.      Eligibility:      - Individuals at least 18 years of age who have OCA1B.      Design:        -  This study will last about 18 months. It requires eight outpatient visits, each about 3          months apart. Each visit will require 1 to 2 days of testing.        -  Participants will be screened with a physical exam, eye exam, and medical history. They          will have additional vision and neurological tests. They will be tested to see how their          brain and retinas respond to light. They will also take hair and blood samples, and          answer questions about diet.        -  Participants will receive the study drug. They will take one pill a day for 1 year. They          will keep track of the dose in a study diary.        -  At the outpatient visits, participants will have the following tests:        -  Medical history and physical exam        -  Neurological and eye exams        -  Retina function tests        -  Tests of the skin and brain's response to light        -  Blood and urine tests        -  Dietary consultation        -  Visual function questionnaire.        -  After the end of the study, participants will return to the care of their regular eye          doctor.   "
110576|NCT01838642|"     Background:        -  Medullary thyroid cancer (MTC) represents 5% of thyroid cancers and presents as a          hereditary (25% of cases) or sporadic (75% of cases) neuroendocrine malignancy.        -  MTC arises from the parafollicular C-cells of the thyroid.        -  Germline mutations in the rearranged during transfection (RET) proto-oncogene occur in          virtually all of hereditary MTC cases, and somatic RET mutations occur in 50% of          sporadic cases.        -  Drugs targeting RET kinase such as vandetanib and cabozantinib have shown efficacy in          the treatment of advanced or metastatic MTC, however, more effective RET inhibitors are          needed for previously untreated patients as well as patients who have become refractory          to other molecular targeted therapeutics (MTTs).        -  Ponatinib, a drug that is Food and Drug Administration (FDA) approved as a therapy for          chronic myelogenous leukemia      (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is a     potent inhibitor of RET kinase.      Primary Objective:      -To determine the objective overall response rate (complete response [CR] + partial response      [PR] by Response Evaluation Criteria in Solid Tumors (RECIST) to ponatinib in the treatment     of patients with advanced or metastatic MTC previously treated with cabozantinib and     vandetanib who: 1) have tumors with RET mutations and 2) have tumors without RET mutations.      Eligibility:        -  Patients must have histologically confirmed, unresectable, locally advanced or          metastatic MTC, with measurable disease by RECIST criteria.        -  Patients must have disease amenable to biopsy and be willing to undergo biopsy for          molecular analysis, and also have adequate archival material from their thyroidectomy or          from a tumor biopsy obtained prior to beginning any systemic therapy.        -  Patients must have failed or been intolerant to prior treatment with both cabozantinib          and vandetanib.        -  The last dose of prior systemic therapy must be more than 28 days prior to the first          dose of ponatinib        -  Radiation therapy is permitted if the last treatment was received more than 28 days          prior to the first dose of ponatinib.      Design:        -  Open label phase II trial with 2 treatment groups:        -  RET mutation positive MTC, previously treated with vandetanib and cabozantinib        -  RET mutation negative MTC, previously treated with vandetanib and cabozantinib        -  Patients will receive ponatinib 30 mg orally daily until disease progression or until          the development of intolerable side effects.        -  Tumor response will be assessed by RECIST 1.1 criteria at 8 weeks and then every 12          weeks thereafter. After one year on study, tumor response will be assessed every 16          weeks.        -  Patients will have a biopsy of their MTC for molecular analysis prior to initiating          treatment with ponatinib. Patients will also have a biopsy of their MTC at the time of          tumor progression, should that occur.   "
110579|NCT01838603|"     There are quite a few qualitative studies done to find out patients experience of chronic     pain. There are no studies on what the patients feel and what thoughts and feelings arise in     the patients that are exposed to interventional pain management. This study aims to     illuminate how it is to live through an interventional pain management program.   "
110581|NCT01838577|"     The investigators wish to document the distribution of EGFR somatic mutations, and assess the     relationship between specific genotype, clinical demographic, therapy, and survival, in a     large cohort of EGFR mutant NSCLC.      The investigators also wish to comprehensively investigate the relationship between germline     DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association     Studies) and candidate gene approach, and explore the relationship between germline DNA and     clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI     (Tyrosine Kinase Inhibitor) outcome.   "
110582|NCT01838564|"     Over 50% of children dying from cancer still suffer from symptoms that could be effectively     alleviated. The purpose of the Pediatric Quality of Life and Evaluation of Symptoms     Technology (PediQUEST) Study was to evaluate whether providing feedback to families and     providers about how the child is feeling improved child distress and quality of life (QoL) in     children with advanced cancer.      PediQUEST is a computerized survey that asks the child and/or parents how the child has been     feeling, i.e. whether the child had any physical or emotional symptoms, as well as how other     aspects of life, such as school and friends, are going. After the survey is complete a report     that summarizes patient/parent answers is printed. When a child reports moderate to high     distress from any symptom an email is automatically sent to the primary providers     (oncologist, nurse, and psycho-social clinician as well as the pain and palliative care     services) alerting them about the child's distress.      In this study we evaluated whether using PediQUEST and providing printed reports to parents     and providers reduced distress and improved quality of life in children with advanced cancer.     In addition, we wanted to understand whether it was feasible to carry out a randomized     controlled trial in children with advanced cancer. Finally, the data collected, will be used     to describe the natural history of symptoms and quality of life as reported by the children.      Children enrolled in the study (or their parents) were asked to complete a PediQUEST survey     at most once a week. A random half of the children received the feedback intervention, i.e.     patients, parents, and providers received printed reports (and emails if the child was in     distress). The other half only completed the PediQUEST surveys and did not receive reports.     We analyzed data collected over 20 weeks of follow-up to see whether receiving PediQUEST     reports had any effect on child distress and quality of life.   "
110583|NCT01838551|"     The primary objectives of this study are to evaluate the efficacy of ascending doses of     COR-003 in subjects with elevated levels of cortisol due to endogenous Cushing's Syndrome by     assessment of reduction in Urinary Free Cortisol (UFC) concentrations and to identify the     range of safe and effective doses of COR-003 that reduce mean UFC concentrations ≤ULN (upper     limit of normal) of the assay at month 6 of the maintenance phase of dosing without a prior     dose increase in that phase.   "
110584|NCT01838538|"     To study the efficacy and safety of intraperitoneal injection bevacizumab combined with     intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of     ovarian cancer. To analyze the clinical significance of the concentration change of vascular     endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection     bevacizumab   "
110585|NCT01838525|"     To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and     prognosis of patients with sepsis, and then compared with C-reactive protein (CRP),     procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health     Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164     patients were enrolled in the study, including 25 cases with systemic inflammatory response     syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe     sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive     protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on     the day of admission to intensive care unit (ICU).   "
110586|NCT01838512|"     This is a non-interventional observational study aimed at understanding the real world     effectiveness of novel agents used in treating multiple myeloma and their impact on     patient-reported outcomes. This study will collect information that is already in medical     records regarding treatment and diagnostic procedures. Patients are asked to complete     questionnaires for patient-reported outcome measures.   "
110587|NCT01838499|"     The purpose of this study is to gain initial evidence for the safety, tolerability and     efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis     suppurativa   "
110588|NCT01838486|"     Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention     (BTD).   "
110589|NCT01838473|"     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users     will be given repeated doses of four different types of portion snus: General, Catch,     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.   "
110590|NCT01838460|"     To compare each subject's AUCinf, after administration of one single dose of 6 mg of     Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of     SS containing 16 mg nicotine.   "
110591|NCT01838447|"     Our research group has shown that almost all children with congenital heart disease (CHD) are     vitamin D deficient following heart surgery. This work strongly suggests that the vitamin D     intake presently recommended for healthy children, and also given to children with CHD, is     inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there have been     no studies investigating any other vitamin D dose in children with heart disease. Recently, a     higher dose of vitamin D intake has been approved (by the Institute of Medicine and Health     Canada) and recent work on healthy children has shown it to be safe. The objective of this     study is to determine whether this recently approved higher dose of vitamin D can safely     reduce the number of children who are vitamin D deficient following surgery. This dose     evaluation study will also evaluate whether it is possible to perform a large study (across     Canada) to determine whether vitamin D supplementation can improve outcomes following     surgery. It is hypothesized that a daily high dose vitamin D regimen, modeled on the     Institute of Medicine daily upper tolerable intake level (UL), will significantly reduce     vitamin D deficiency following CHD surgery, when compared with usual intake.   "
110883|NCT01834586|"     The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will     reduce the injection pain. Relieving injection site pain may improve the tolerability of     Multiple Sclerosis medications.      Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings     as measured by the visual analog scale and Local injection site reaction scale.   "
110592|NCT01838434|"     This Phase I/II trial studies the safety and effectiveness of lenalidomide with or without     idelalisib. Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Idelalisib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     lenalidomide is more effective with or without idelalisib in treating mantle cell lymphoma.   "
111718|NCT01823887|"     The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve     stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with     symptomatic heart failure.   "
110594|NCT01838408|"     This study aims to provide safety and efficacy data comparable to available over-the-counter     bowel preparations prior to colonoscopy. While there are many bowel preparations available,     most of them remain expensive and require prescription from a health provider. The     investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more     accessible way (over-the-counter).      To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination     versus currently available over-the-counter bowel preparations. The investigators believe the     EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.   "
110595|NCT01838395|"     The goal of this clinical research study is to learn if BL-8040 in combination with     cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia     (AML) that has relapsed or did not respond adequately to previous treatment. The safety of     the study drug combination will also be studied.   "
110596|NCT01838382|"     Laparoscopic operative procedures have revolutionized gynecological surgery. These have     several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter     postoperative stay, which cuts down on hospital costs. However, postoperative pain continues     to be one complication, which results in an unpleasant experience for the patient and at     times causes a delayed discharge. There are few studies about pain characteristics as one of     laparoscopic hysterectomy complications. The purpose of this study is to investigate the     prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in     patients undergoing total laparoscopic hysterectomy.   "
110597|NCT01838369|"     The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients     diagnosed with smoldering multiple myeloma.   "
110598|NCT01838356|"     The purpose of the study is to examine if blood flow in the brain before coronary artery     bypass graft surgery has an effect on depression after surgery.      The main hypothesis of the study states that pre-surgical blood flow in the brain will be an     independent risk factor for depression after surgery after adjusting for other risk factors     such as gender, pre-CABG depression, social support, medical comorbidity burden,     socioeconomic status, and neuroticism.   "
110599|NCT01838343|"     Rapid response team systems have been implemented in numerous hospitals throughout the world     with the goal of improving the identification and safety of hospitalized patients who are     clinically deteriorating. Despite their theoretical benefit, rapid response systems have not     been proven in the medical literature to ultimately change outcomes.      The traditional physical exam is helpful in evaluating and treating unstable medical patients     during these types of events but has significant limitations of deceased sensitivity and     specificity of findings. Ultrasound is a known tool for more accurately assessing patients in     shock and respiratory failure in the ICU by highly trained operators but to the investigators     knowledge has not been studied in the setting of rapid response events on hospital wards by     critical care fellows after focused training. The investigators aim to assess the impact of     ultrasound performed by critical care fellows during rapid response events.   "
110600|NCT01838330|"     Loss of kidney function results in accumulation in the blood of molecules that are either     excreted or metabolized by the kidney. Collectively, these molecules are termed Uremic     Retention Molecules (URMs) or toxins. It is increasingly recognized that colonic bacterial     metabolites like p-cresyl sulfate and indoxyl sulfate that are absorbed from the colon and     excreted by the kidney may contribute to the pool of compounds implied in uremic toxicity.     Indeed, these URMs have been linked to increased levels of inflammation markers, chronic     kidney disease (CKD) progression, cardiovascular disease and overall mortality in CKD and/ or     hemodialysis patients. Therefore, interventions that target the production or absorption of     URMs from the gut might decrease inflammation and oxidative stress that are commonly seen in     the uremic milieu. The National Health and Nutrition Examination Survey III (NHANES III) data     show that high dietary fiber intake is associated with decreased serum levels of C-reactive     protein (CRP) in those with and without CKD and these associations are much stronger in the     CKD population. A possible explanation of this effect is that a high fiber diet in CKD     patients modulates the bacterial production, intestinal absorption and finally the serum     levels of URMs like p-cresyl sulfate and indoxyl sulfate, which in turn results in decrease     in inflammation.      OBJECTIVES:      Hypothesis:        1. Higher serum levels of markers of inflammation such as high sensitivity C-reactive          protein (hsCRP), interleukin 6 (IL-6) and tumor necrosis factor (TNF) -α seen in stage 4          CKD (estimated Glomerular Filtration Rate 15-29 ml/min/1.73 m2) compared to stage 2 CKD          (estimated Glomerular Filtration Rate 60-89 ml/min/1.73 m2) is partly explained by the          higher circulating levels of URMs (p-cresyl sulfate and indoxyl sulfate) in stage 4 CKD,          and        2. Dietary supplementation in stage 4 CKD with 30g/d of a soluble fiber Psyllium (brand          name-Metamucil TM) will decrease circulating URMs levels and thereby, decrease serum          levels of inflammation markers and urinary levels of transforming growth factor (TGF)-β,          a marker of kidney fibrosis.   "
110601|NCT01838317|"     This study is being done to determine whether or not addition of the oral medication,     pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the     body's ability to utilize sugar (glucose and insulin metabolism). In addition the     investigators want to determine whether or not treatment with pioglitazone results in (1)     improvement in the size of the tumor, (2) weight gain, (3) improved ability to function     during the day and (4) quality of life.   "
110602|NCT01838304|"     Endoscopic sedation requires titration of propofol to deep sedation without minimum overshoot     into general anesthesia. This skill is demanding and acquired slowly. Probability Ramp     Control (PRC) simplifies this by providing the clinician with a simple infusion sequence that     permits gradual titration of propofol. The purpose of this study is to compare the     performance of this technology to that of experienced anesthesia providers in endoscopic     sedation.   "
110603|NCT01838291|"     Observational, open label, prospective, multi-center, post-marketing drug surveillance     program.   "
110604|NCT01838278|"     - Justification: Prematurely born children have an increased prevalence of neurodevelopment     problems in the first two years. Knowledge regarding the effects of early intervention     programs is essential to the follow up of these children and the families.      -Hypothesis: The Vojta Therapy Model showed beneﬁcial effects on motor development outcomes     reported by Bayley Sales of Infant Development-Second Edition, in the first 18 months of life     on European sample.   "
110605|NCT01838265|"     1. Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more          accurate sampling of the tumors and therefore will increase the rate of progression on          early (first and second) surveillance biopsies and decrease the rate of progression on          late (third and further) surveillance biopsies compared to Transrectal Ultrasound-guided          biopsies.        2. Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or          MRI-guided and Transrectal Ultrasound-guided biopsies.        3. Biomarker expression levels will correlate with biopsy progression.   "
118151|NCT01739452|"     Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of     patients with MDS. The information will be collected retrospectively from diagnosis of MDS,     until the date of December 31, 2011.   "
110606|NCT01838252|"     Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can     result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic.     Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be     damaging to the cornea. The definitive therapy for lid retraction is surgical, and often     involves complicated procedures including tissue grafting.      Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by     subcutaneous injection and volume addition. These gels have gained wide popularity in for     cosmetic applications in filling volume deficit areas. Functional applications in the     periorbital area have also been described including the filling of volume deficit     anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG     to be useful in correcting both upper and lower eyelid retraction, with good effect.      The purpose of this investigation is to define the clinical utility of HAG correction of     lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on     cornea) and qualitative effects (symptom severity).      Our hypothesis is that HAG correction of lower eyelid retraction will improve patient     comfort, clinical signs of dry eye and aesthetic self image.   "
110607|NCT01838239|"     The purpose of this study is to examine the variation between individuals in blood lipid     metabolites, and the changes in these metabolites in response to omega-3 fatty acids in     patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. The hypothesis is     that measuring variation among individuals and changes in response to omega-3 fatty acids     comprehensively by using metabolomics will help to identify those individuals who are     responders and those who are non-responders to omega-3 fatty acids as an anti-inflammatory     intervention.   "
110609|NCT01838213|"     This project aims at investigating the duration of human fecal carriage of bacteria harboring     plasmid-borne resistance genes expressing Extended Spectrum beta-lactamases (ESBL), risk     factors for infections with such bacteria and persistence, mobility and spread of ESBL in the     environment and within households. It also aims to compare different methods of detecting     ESBL carriage and treat patients with urinary tract infection caused by these bacteria.   "
110610|NCT01838200|"     This is an open-label, dose-escalation, non-randomized, phase I study in patients with     histologically confirmed Stage III or IV melanoma and at least three metastatic cutaneous or     subcutaneous lesions suitable for: intralesional (IL) injection (1 lesion), accessible for     biopsy (1 lesion), and response evaluation by RECIST (v1.1) and modified RECIST (irRC) (1     lesion). The primary objective is to determine whether IL administration of BCG followed by     intravenous (IV) infusion of ipilimumab is safe. Ipilimumab (YERVOY®) is the monoclonal     anti-CTLA-4 antibody approved by the FDA and TGA as anticancer therapy for melanoma.     Secondary objectives of the study are: a) clinical efficacy, to document whether this     combination therapy induces tumour responses; and b) immunogenicity, to identify if the     combination induces immune responses against the tumours. All patients will be included in     the analysis of efficacy and immunogenicity.      Cohort 1 (9 patients with <10mm induration after tuberculin Purified Protein Derivative [PPD]     test): Group 1 (3 patients) will receive one IL injection of 200 µl BCG containing 0.16 -     0.64 x 106 cfu followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on     day 36. Group 2 (3 patients) and 3 (n=3) will receive 200 µl BCG containing 0.8 - 3.2 x 106     cfu and 4.0 -16.0 x 106 cfu, respectively, followed by the same ipilimumab regimen. Safety     will be evaluated in this cohort.      Cohort 2 (up to 9 patients with ≥10mm induration after PPD test): Enrolment will start after     the final patient in Cohort 1, Group 1 has reached study week 7. Then enrolment can proceed     in parallel for Cohort 2 and Cohort 1 Groups 2 and 3. Patients will receive 0.16 -0.64 x 106     cfu BCG followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on day     36. Evaluation of safety in this cohort will be observational.   "
110611|NCT01838187|"     Currently there is no known effective treatment for patients with advanced stage     neuroblastoma, pheochromocytoma, or paraganglioma who have relapsed or not responded to     standard therapy. In previous studies that used 131I-MIBG as a potential anti-cancer therapy,     a decrease in the size of tumors was seen in some of the children and adults. This research     study will continue to evaluate the side effects of 131I-MIBG when treating children and     adults with neuroblastoma, pheochromocytoma, or paraganglioma. The 131I-MIBG compound is     intended to work by selectively delivering the radioactive iodine to the tumor cells, which     is then intended to result in their destruction.      The purpose of this research study is to:        -  Make 131I-MIBG therapy available to patients with advanced neuroblastoma,          pheochromocytoma, or paraganglioma        -  Further assess the side effects of 131I-MIBG therapy   "
110612|NCT01838174|"     We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of     Adrenocorticotropic hormone (ACTH) will reduce axonal loss following ON by limiting     inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous     methylprednisolone therapy on axonal injury following ON using ocular coherence tomography     (OCT), a sensitive, reproducible and noninvasive tool to measure retinal nerve fiber layer     (RNFL) thickness.      The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified     statistical analyses will compare the difference in the mean RNFL thickness at 6 months in     the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean     6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The     secondary outcome measure will examine the frequency of optic nerves with RNFL swelling     between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. The tertiary     outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary     diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus     inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups   "
110690|NCT01837147|"     Women who are overweight or do not exercise are at higher risk for breast cancer after     menopause. This study will test a new electronic device that measures the body's movement and     works alongside a website to help women increase their physical activity level. If effective,     this system could be tested in larger studies aiming to reduce breast cancer risk by reducing     or preventing obesity.   "
118997|NCT01728350|"     The purpose of this project is to determine if participating in volunteer activity improves     the psychological well-being of individuals with traumatic brain injury (TBI).   "
110613|NCT01838161|"     The proposed project develops a community and school-based intervention to enhance     understanding of the importance all age-appropriate vaccinations, and uses an innovative,     comprehensive approach (Project INSPIRE - Instilling Necessary Sickness Prevention with     Immunizations Reaching Everyone) to ensure that all parents of adolescents are advised of all     age-appropriate vaccines for sickness prevention. The investigator will develop a novel set     of targeted video vignette persuasive informational decision aids (including target     population representatives) to enhance lay understanding of recommended adolescent (or     catch-up) vaccines. The Investigator will also partner with school districts to develop a     replicable social marketing vaccination event program (Project INSPIRE) to encourage parents     and teens to publicly vaccinate at community events and during drop-in school nursing clinic     hours. The project will test the efficacy of the video-based health education intervention +     standard of care to ideal standard of care (social marketing vaccination event program)     approaches to immunize adolescents in this region.   "
110614|NCT01838148|"     The primary aim is to perform the largest study worldwide to evaluate novel biochemical and     electrocardiographic signatures alone as well as in combination with the standard 12-lead     exercise ECG in the detection of exercise-induced myocardial ischemia (diagnostic endpoint).     The secondary aim is to evaluate these innovative tools in the risk prediction for the     occurrence of cardiovascular death and acute myocardial infarction during long-term     follow-up.   "
110615|NCT01838135|"     Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important     psychological factor for wheelchair mobility. A feasibility study will evaluate a novel     self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to     determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use,     confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in     older adults compared to group-based information sessions; and 3. the study design is     appropriate. This feasibility study will allow for study design and protocol refinement and     will provide pilot data for an experimental trial.   "
110616|NCT01838122|"     Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes     Association has suggested screening of women with PCOS for HbA1C.   "
110617|NCT01838109|"     Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition     due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption     function, and/or metabolic changes after surgery. The postoperative malnutrition is     associated with low quality of life and seems to be related long-term nutritional status.     This study is a multicenter, open-labeled prospective randomized clinical trial to examine     the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal     surgery by comparing the change of body weight and other nutritional parameters between the     experiment group that is supplied with ONS and the control group without ONS.   "
110618|NCT01838096|"     This study will evaluate clinical outcome on patients who undergo cementless 4th generation     ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total hip     aArthroplasty (THA) in patients younger than 30 years.   "
110619|NCT01838083|"     Primary Objective:      To demonstrate equivalence in exposure to insulin glargine given as test formulation T and     reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses      Secondary Objective:        -  To assess relative Pharmacodynamic activity of the insulin glargine test formulation T          to the insulin glargine reference formulation R in steady state conditions after 6          once-daily SC doses        -  To assess the safety and tolerability of the test and reference formulations of two new          insulin glargine formulations   "
110620|NCT01838070|"     This safety surveillance study is being conducted in accordance with Korea Food and Drug     Administration (KFDA) Basic standard for reexamination of new drug.      Primary objective:        -  To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine          practice, according to Korea Food and Drug Administration Basic standard for          reexamination of new drug based on the pharmaceutical law in Korea.   "
110621|NCT01838057|"     To evaluate the impact of painPRIMER in a prospective six-month clinical investigation     looking at clinical outcomes, health care professional and patient satisfaction, healthcare     resource use, productivity and direct and indirect costs. The hypothesis is that early     identification of the presence of neuropathic pain and back pain related comorbidities, to     direct appropriate pharmacologic and non-pharmacologic treatment, painPRIMER would improve     patient outcomes and reduce patient cycling, inappropriate use of imaging and surgery,     thereby reducing costs and productivity loss associated with these inefficiencies.   "
110622|NCT01838044|"     The purpose of this study is to determine if treatment with celecoxib and pregabalin together     would prove to be more effective in relief of pain than treatment with celecoxib alone in     people who have chronic low back pain with a probable neuropathic component.   "
110623|NCT01838031|"     Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal     subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome     and cognitive function in the children.   "
110624|NCT01838018|"     The purpose of this study is to learn whether blood flow in the brain is normal in people     with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data     suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN,     may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to     learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other     brain regions as well as to healthy controls.   "
110625|NCT01838005|"     The goals of the proposed study are to: 1) test whether small, increasing cash payments to     HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and     receive proposed services, will increase the proportion of women who receive the most     effective antiretroviral regimen they are eligible for by the time of delivery, and 2)     elucidate factors that facilitate or inhibit the uptake and adherence to the PMTCT cascade,     and to what extent the conditional cash payment program addresses these factors.      This intervention will be implemented and evaluated within our well-established PMTCT program     in Kinshasa, Democratic Republic of Congo (DRC),   "
118368|NCT01736618|"     The purpose of the S-ICD Post Approval Study is to document long term safety and     effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and     Q-TRAK electrode in a commercial clinical setting.   "
110626|NCT01837992|"     The Melanesian states of the Western Pacific (Papua New Guinea, Solomon Islands and Vanuatu)     represent a unique and especially prescient challenge to malaria control and elimination.      While the use of bed nets and other vector control and case management measures have achieved     major advances in overall malaria control, the P. vivax and P. ovale species account for an     ever-increasing burden of clinical disease.      The lack of effective treatment of the hypnozoite stages of infection with these species     result in ongoing relapses and a continuing reservoir of infection.      The only known drug effective for treatment of the hypnozoite stage is primaquine; however     the safe and effective dose of this drug in malaria treatment is still unclear.      A recent study evaluated the safety and efficacy of two primaquine dosing regimens (0.25mg/kg     and 0.5mg/kg) in a population in New Ireland province, PNG. This study aims to replicate this     methodology in Vanuatu and Solomon Islands, to provide a more complete picture of primaquine     efficacy and safety in each of the three countries of this region.   "
110627|NCT01837979|"     There are 26,600 Down Syndrome newborns every year in China. The economic burden of this     disease is 65,000 USD for lifetime of every patient. The common prenatal screening and     diagnosis procedure for fetal chromosomal abnormalities in China is maternal serum prenatal     screening in second trimester followed by amniocentesis. The detection rate of MSS is 70%-75%     with 5% false positive rate. There are only 13.9% of pregnant women can receive prenatal     screening testing in China. It is very urgent that we build a training system and convenient,     efficient, cost-effective procedure suitable to rural China.      The use of dried blood spots (DBS) technology in conjunction with the second trimester     prenatal screening protocol has been proved to be as efficient as serum screening by our     previous study. Noninvasive prenatal testing that uses cell free fetal DNA (cff DNA) from the     plasma of pregnant women offers a tremendous potential for fetal chromosomal abnormalities. A     positive test should be followed by invasive prenatal diagnosis to confirm the test results.     Cff DNA is a good supplement to the DBS technology in rural China. A combination of the two     methods can increase the screening rate and accuracy without increasing the demand of     amniocentesis and cytogenetic test. This procedure with adequate training system should be     suitable to rural China.      Our study will build a training system for DBS and cffDNA prenatal screening procedure in     Pinggu, Beijing. Two thousand pregnant women will receive prenatal screening. DBS sample will     be collected in the second trimester, Cff DNA is offered to confirm the positive screening     test results, and lastly amniocentesis is offered for confirmation of the test results. All     of the pregnancy and neonatal outcomes will be followed. We can estimate the efficiency and     cost-effectiveness of DBS followed with cff DNA screening procedure.   "
110628|NCT01837966|"     The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in     breast surgery patients.   "
110629|NCT01837953|"     Binge Eating Disorder (BED) affects as many as 3% of women and men in Ontario, 8% of obese     individuals, and 30% to 50% of those participating in weight loss programs. BED, the most     common eating disorder, is characterized by over-eating with loss of control (i.e., binge     eating), but with no purging (e.g., vomiting).Our previous research indicates that the total     health care costs for women with BED is 36% higher than the Canadian average for women of a     similar age, and that health care costs significantly decreased following intensive treatment     at our Centre. The main goal of our study is to inform the development of a stepped care     approach to the treatment of BED. Stepped care involves providing easily accessible low     intensity treatment first, and then providing more expensive intensive treatment second, if     necessary. The second goal is to assess if a second more intensive step of treatment provides     added value. Although stepped care for BED is suggested by a number of clinicians and     researchers, no study adequately tests predictors of who might benefit from minimal treatment     alone and who would require the more intensive second step. The results of this study will     guide decision making regarding who benefits from stepped care, and will help to increase the     accessibility, availability, and cost effectiveness of psychological treatments for BED.   "
110630|NCT01837940|"     The purpose of this study is to investigate the effect of a daily supplement consisting of     the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years     and older.   "
110631|NCT01837927|"     This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as     active control in COPD patients.   "
110632|NCT01837914|"     Obstructive Sleep Apnea is a serious medical condition affecting an estimated 1-5% of     children. The disease is believed to have several overlapping causes including large tonsils     and small or narrow jaws. This prospective, randomized cross-over study will evaluate the     effectiveness of orthodontic treatment of narrow upper teeth and jaws compared to the current     standard of care which is surgical removal of the adenoids and tonsils.      Patients will be evaluated by both an orthodontist and ENT physician, complete a series of     questionnaires and undergo an overnight sleep study, both initially and after undergoing the     randomized treatment. Patients who on reassessment have residual symptoms of sleep apnea will     then be crossed over and receive the other form of treatment. The levels of improvement to     both subjective (questionnaire) and objective (overnight sleep study) measures of sleep apnea     will then be compared.      The null hypothesis is there is no significant difference in improvement between maxillary     expansion and adenotonsillectomy in the objective and subjective outcome measures in children     with mild to moderate obstructive sleep apnea.   "
110633|NCT01837901|"     The purpose of this study is to determine the long term effects of transcorneal     electrostimulation (TES) in patients with retinitis pigmentosa (RP). In a prior study     (NCT00804102) the results of short term stimulation pointed to a positive effect on the     visual field and other parameters. In this study, the patients will be stimulated with either     0%, 150% or 200% of the individually determined phosphene threshold.   "
110634|NCT01837888|"     Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important     psychological factor for wheelchair mobility. A feasibility study will evaluate a novel     self-efficacy enhanced wheelchair training intervention (WheelSee) to determine if:     1.WheelSee improves self-efficacy compared to standard care; 2. study design is appropriate;     and 3. The WheelSee intervention protocol is suitable. This feasibility study will allow for     study design and protocol refinement and will provide pilot data for an experimental trial.   "
110645|NCT01837745|"     Open-label randomized phase III trial, using a non-inferiority comparison design. After     randomization,patients will receive either post-operative radioiodine ablation with an     activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation     group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).      The objective is to assess the non-inferiority of the proportion of patients without     tumor-related event evaluated at three years after randomisation in the absence of     radioiodine ablation (follow-up group) compared to the ablation group, in patients with     low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph     node dissection (pT1am N0 or Nx, pT1b N0 or Nx)   "
118402|NCT01736176|"     The primary objective of this study is to evaluate change in non-motor symptoms from baseline     to Week 12 as measured by the Non-Motor Symptom Scale total score.   "
110635|NCT01837875|"     The goal of the proposed project is to enhance the Principal Investigator's research ability     to conduct behavioral interventions for people with lupus. This includes intervention design,     implementation, data collection and data analysis. The Intervention to Improve Quality of     life for African-AmericaN lupus patients (IQAN) Project is designed to examine whether a     uniquely tailored intervention program can improve quality of life, decrease indicators of     depression, and reduce perceived and biological indicators of stress in African American     lupus patients. This study builds on three decades of work conducted in the field of     arthritis self-management but differs in that the intervention mode, the disease (lupus), and     the study population (African-Americans) are unstudied or understudied. The IQAN Project will     use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model as its     theoretical framework. This program has three specific aims. The first aim seeks to design a     three armed randomized, wait list controlled trial that employs a patient-centered     'a-la-carte' approach that offers subjects a variety of modes of interaction, allowing them     to choose as many or few as they wish. The second aim is to assess the intervention, using     the RE-AIM model framework. The third aim, to be achieved before the first aim, is to use     previously collected data to characterize patient-centric barriers to care in     African-American lupus patients, in order to identify trends in patient needs and desires, as     well as correlates of non-response and non-compliance that can be used in the development and     refinement of the intervention.   "
110636|NCT01837862|"     This is a study to determine the safety and efficacy of the drug, mebendazole, when used in     combination with standard chemotherapy drugs for the treatment of pediatric brain tumors.     Mebendazole is a drug used to treat infections with intestinal parasites and has a long track     record of safety in humans. Recently, it was discovered that mebendazole may be effective in     treating cancer as well, in particular brain tumors. Studies using both cell cultures and     mouse models demonstrated that mebendazole was effective in decreasing the growth of brain     tumor cells.      This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade     gliomas are tumors arising from the glial cells of the central nervous system and are     characterized by slower, less aggressive growth than that of high-grade gliomas. Some     low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or     recurrence.      Low-grade gliomas are often able to be treated by observation alone if they receive a total     surgical resection. However, tumors which are only partially resected and continue to grow or     cause symptoms, or those which recur following total resection require additional treatment,     such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when     totally resected, will often be treated with chemotherapy. The current first-line treatment     at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of     vincristine, carboplatin, and temozolomide. However, based on our data from our own     historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have     disease progression while on this treatment. We believe that mebendazole in combination with     vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with     increased progression-free and overall survival for low-grade glioma patients, particularly     for those with pilomyxoid astrocytomas.      High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is     radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but     with disappointing results. For high-grade gliomas this study will add mebendazole to the     established combination of bevacizumab and irinotecan to determine this combinations safety     and efficacy   "
110637|NCT01837849|"     To compare the therapeutic efficacy of recombinant human brain natriuretic peptide (rhBNP)     with dobutamine on acute decompensated heart failure patients with different blood BNP levels   "
110638|NCT01837836|"     The purpose of this study is to assess the drinking water handling practices at household     level and to determine the effect of health education on the drinking water handling.     Participants from study villages, mainly homemakers, school children and water tank operators     who are willing to participate, will be targeted.      Baseline assessment of household practices related to water will be done. Followed by a     health education regarding the healthy practices will be given to them. Practice of household     water chlorination will be promoted. The healthy behavior will be reinforced through     reminders and community activities of self help groups for one year.      The study participants will be benefited from survey in terms of        1. Improved knowledge and practices of drinking water handling        2. Risk reduction of water borne illness to family members   "
110639|NCT01837823|"     Coronary artery disease (CAD) remains a leading cause of death in most countries. It is well     known that the reduction of cholesterol levels by statin therapy is associated with     significant decreases in plaque burden. REVERSAL, ASTEROID, and more recently the SATURN II     trial showed that in patients with CAD, lipid lowering with atorvastatin or rosuvastatin     respectively reduced progression of coronary atherosclerosis, even causing plaque regression     of some lesions. CAD clinical events are related to plaque instability due to lipid content     and activity within the atherosclerotic plaque. The investigators recently completed the     YELLOW I study, and identified that intensive statin therapy (rosuvastatin 40mg) was     associated with a reduction in the amount of lipid in obstructive coronary plaques, as     measured by near-infrared spectroscopy (NIRS). The YELLOW II study is designed to expand and     build upon these results, and to provide mechanistic insights into the potential benefits of     intensive statin therapy on atherosclerotic plaques.   "
110640|NCT01837810|"     The purpose of this study is to determine if ibuprofen use after electrocautery tonsillectomy     increases the post-tonsillectomy hemorrhage rate.      Hypothesis: Use of ibuprofen does not increase the post-tonsillectomy hemorrhage rate.      Primary outcome: Rate of tonsillar hemorrhage following adult tonsillectomy in those     receiving narcotic pain medications plus ibuprofen compared to those receiving narcotics     alone.      Secondary outcome: Determine whether ibuprofen, a non-steroidal anti-inflammatory drug     (NSAID), decreases post tonsillectomy pain, narcotic pain medication use, or cost of pain     management.   "
110641|NCT01837797|"     To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly     patients with Major Depressive Disorder (MDD)   "
110642|NCT01837784|"     Guidelines recommend measuring end organ damage and in particular arterial stiffness in     patients with hypertension. However, until now it was not possible to measure arterial     stiffness with the use of simple methods. Recently, novel and innovative devices offering     determination of arterial stiffness and central hemodynamics from simple and non-invasive arm     cuff measurements have now become available. This study therefore evaluates the value of     non-invasively measured arterial stiffness and central hemodynamics for guiding     antihypertensive treatment in selected patient populations (i.e. elderly patients, patients     with diabetes mellitus, patients with heart failure, and patients with resistant     hypertension).   "
110643|NCT01837771|"     The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by     interventionally placed electrodes may improve heart function, symptoms and functional     capacity in patients with severe heart failure.   "
110644|NCT01837758|"     Aim of the study is a description of changes in platelet function during continuous     veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the     Multiplate system.   "
110649|NCT01837693|"     In industrialized countries, cervical cancer is a well controlled disease thanks to the     diffusion of Pap test and, in particular, to organized screening programs, which are able to     detect and treat pre-invasive lesions (cervical intraepithelial neoplasia, CIN). The human     papilloma virus (HPV) has been recognised as the necessary, but not sufficient, cause of     cervical cancer, so a new screening test based on the identification of high risk (HR) HPV     types has been developed(HPV DNA test). This test has demonstrated to be more effective than     cytology in reducing the incidence and the mortality of cervical cancer, but it is less     specific, so the use of a test triage is necessary to reduce the number of colposcopies and     the risk of over-diagnosis (due to the potential regressivity of pre-invasive lesions). Until     now, the triage test used is the cytology (Pap test).      Recently specific biomarkers (mRNA and p16 tests) have been introduced for high grade CIN,     targeting the molecular alterations strictly associated to transformation rather than simply     detecting HR-HPV infections. These tests are more specific than HPV DNA test with a modest     reduction of sensitivity for high-grade lesions.      This is a multicenter randomised trial nested into some Italian screening programs based on     the use of HPV DNA test as primary test.      All women with positive HPV DNA test will be tested for cytology and also for mRNA and p16.     Women with positive cytology will be referred to colposcopy, while women with negative     cytology will be randomized into two arms.      This study aims to evaluate if mRNA and p16 could be used as test of triage of HPV DNA or as     a primary screening test with direct sending in colposcopy.      In particular the main objectives are:        -  Measuring the cumulative detection rate of CIN2+ in the five years following a HPV DNA          positive test and mRNA or p16 negative.        -  Measuring the potential reduction of overdiagnosis of using mRNA or p16 test instead of          DNA, with direct sending in colposcopy        -  Measuring the reduction of overdiagnosis of cytological triage or triage with mRNA or          p16 compared to the direct sending in colposcopy in women with HPV DNA test positive.      Secondary objectives are:        -  to assess the feasibility of mRNA testing in primary screening        -  to validate the sample techniques for the new tests        -  to standardize quality controls for the the new tests   "
110650|NCT01837680|"     The aim of this study is to compare glycemic control in pregnant women treated with insulin     Detemir and pregnant women treated with NPH insulin. These women are diagnosed with     gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2     diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference     between these two treatment modalities in terms of glycemic control in diabetes.   "
110651|NCT01837667|"     The purpose of this study is to test the safety of an investigational drug called LB-100 for     Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a     small molecule that in laboratory and animal studies has shown activity when used by itself     or together with drugs approved to treat some types of cancer (chemotherapeutic agents).     Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of     the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will     receive injections of LB-100. Part 2: Patients will receive injections of LB-100 and     docetaxel. This is the first study where LB-100 for Injection will be used in humans.   "
110652|NCT01837654|"     The purpose of this study is to find out whether plantarflexion has an effect on the degree     of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in     patients with detrusor overactivity (DO).   "
110653|NCT01837641|"     The study will evaluate the safety of LY3002813 by looking at adverse events. The study will     also look at the effect the body has on LY3002813. Study participants will be healthy or will     have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD.      There will be seven groups of study participants. Five groups will receive a single dose of     LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo     given as an injection into a vein. Approximately 12 weeks will pass between the single dose     and the first multiple dose. One group of participants will receive a single dose of     LY3002813 given as an injection under the skin. One group of participants will receive a     single dose of LY3002813 given as an injection into a vein.   "
110654|NCT01837628|"     Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing     urethral pain during urodynamic test.   "
110655|NCT01837615|"     Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that     involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular.     Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations     in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and     the Photopill capsule was developed for this purpose.      An open-label, interventional, clinical trial was designed for assessment of the safety and     feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative     Proctitis.      Primary endpoints being: safety reflected by the number and severity of adverse events and     mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.      Furthermore clinical and biochemical parameters are monitored during the study.   "
110656|NCT01837602|"     An open-label, clinical trial of autologous cMet redirected T cells administered     intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be     enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer     refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with     operable triple negative breast cancer.   "
110657|NCT01837589|"     The purpose of this study is to conduct a comparative study for the study of bone     mineralization evaluated with Quantitative computed tomodensitometry (QCT) compared to the     reference technique, Dual-emission X-ray absorptiometry (DXA).   "
110658|NCT01837576|"     The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations     of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to     Daivobet® gel in order to explore/find other safe and effective combination of the two     components.   "
110659|NCT01837563|"     The purpose of this study is to determine whether four new alternative imaging methods can be     used to follow the response of breast cancer to the treatment patients are being given. These     methods produce an image of the inside of the breast so that doctors can better decide     whether breast cancer is responding to therapy. An important part of the study is to examine     the same person with all methods in order to directly compare results. The four methods are:     MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated     EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy     (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo     a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare     the experimental methods. These additional examinations are accepted diagnostic procedures;     they are not experimental. Some participants will have one or both of these additional     examinations if clinically indicated.   "
110660|NCT01837550|"     The purpose of this study is to examine the short-term effects of complementing an     educational program for hearing aid users with Internet support.   "
118844|NCT01730352|"     The purpose of this study is to determine whether eradication of Helicobacter pylori     infection is effective in the improvement of platelet counts in children and adolescents with     chronic ITP.   "
110662|NCT01837524|"     Randomized trial of grocery-store based nutrition counseling visits for weight management vs.     in-office visits. The investigators will test pre- and post-intervention individual-level     dietary quality, knowledge, self-efficacy around dietary choice, and cost of shopping,     measuring difference between intervention and control arms. At the study's end, the     investigators will also conduct focus groups with a subset of 20 patients (10 from each arm)     and do a structured interview with the dietitian to better understand the feasibility,     strengths and shortcomings of this approach. Patients who complete the main portion of the     trial will be randomly selected for recruitment into a focus group and consented separately     for that focus group at the end of the study.      The investigators hypothesize that, compared to office-based visits, the KP Personal Shopper     visits will result in higher member diet quality scores, better nutritional knowledge scores,     higher self-efficacy and confidence around food purchasing decisions, and more favorable     perception of the visit by both dietician and member. The KP Personal Shopper approach may     also result in increased grocery store costs for some members. Long-term, the investigators     hypothesize that improvements in member perception, knowledge and dietary quality will lead     to improved health outcomes.   "
110663|NCT01837511|"     This study aims to investigate the expression of Melanoma-associated antigen 3 (MAGE-A3),     Melanoma-associated antigen C2 (MAGE-C2), New York esophageal squamous cell carcinoma 1     (NY-ESO-1), L antigen family member 1 (LAGE-1), Wilms' tumor gene (WT1) and PRAME     (PReferentially expressed Antigen of MElanoma) tumor antigens in a large number of     pathologically proven stage I, II and III NSCLC samples of Asiatic patients.   "
110664|NCT01837498|"     The majority of patients undergoing surgery receive neuromuscular blocking agents (NMBAs) in     the operating room. Reversal of neuromuscular blockade at the conclusion of a general     anesthetic is accomplished with cholinesterase inhibitors (primarily neostigmine). Although     these drugs are often effective in enhancing recovery of muscle strength, the onset of effect     is often slow (usually 15-30 minutes). More effective neuromuscular reversal agents are     needed in clinical practice to enhance surgical and anesthetic management of perioperative     patients. A new reversal agent (sugammadex) will likely be approved for clinical use in the     United States next year. Unlike neostigmine, sugammadex is effective in providing rapid     antagonism of all levels of neuromuscular blockade (typically within 2-4 minutes). The aim of     this prospective observational study is to study neuromuscular and clinical recovery in 120     consecutive thoracic surgical patients receiving neostigmine, followed by a 120 consecutive     thoracic surgical patients administered sugammadex (after the drug is approved by the FDA).     In addition, after data on 120 patients reversed with neostigmine is collected, the data will     be analyzed to compare patients with residual block (train-of four < 0.9) and without     residual block (TOF </= 0.9)   "
110665|NCT01837485|"     Some evidences have shown that probiotics are effective in the treatment of irritable bowel     syndrome. Because few evidences are available in our population, we investigated if     probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol     which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.   "
110666|NCT01837472|"     Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome     (IBS), but few reports are available on the effects of multistrain probiotics and there are     few reports available in this regard from our society. Thus, we investigated if probiotics     are effective in our patients as well. We hypothesize that the multistrain probiotic Balance     containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains,     and Streptococcus thermophiles reduces the symptoms of irritable bowel syndrome.   "
110667|NCT01837459|"     In this research study the investigators want to learn more about the risk of developing     blood vessel and heart disease from night-time sleep apnea. Sleep apnea is a condition that     results from blocking of the throat during sleep. This study examines changes in blood     pressure, blood vessel stiffness, heart size and levels of specific substances in the blood     which may cause heart disease.      This study is for children ages 5 to 13 years. The study involves 3 visits over 18 months.     The first and last visits include an overnight sleep study (polysomnography or PSG). All the     visits will include:        -  body measurements to measure growth and how weight is distributed,        -  resting blood pressure measurements,        -  heart measurements (electrocardiogram and ultrasounds of the heart and blood vessels),        -  36 hour home ambulatory blood pressure measurements,        -  blood tests to look at things like fats, cholesterol, inflammatory factors,        -  questionnaires      Optional parts of the study include DNA and for children 8 years and older, testing and     questionnaires to learn more about how sleep relates to learning, memory and behavior issues.   "
110668|NCT01837446|"     Oral mucositis is a debilitating side effects of cancer treatment for which there is not much     successful treatments at yet. The investigators are going to evaluate the effectiveness of     topical morphine compared with a routine mouthwash in managing cancer treatment-induced     mucositis. The investigators hypothesize that topical morphine is more effective and more     satisfied by patients than the magic mouthwash in reducing severity of cancer     treatment-induced oral mucositis.   "
110669|NCT01837433|"     Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute     Thyroiditis      The investigators hypothesize that less adverse reactions will be observed, comparing with     the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent     hypothyroidism aren't significant difference.   "
110670|NCT01837420|"     This study will examine the safety and efficacy in subjects with moderate to severe     psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA),     Dermatology Life Quality Index (DLQI) and other assessments.   "
110671|NCT01837407|"     Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging     problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap     including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous     defect of the proximal phalanx.   "
110691|NCT01837134|"     Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching     have the potential to support lifestyle change and weight loss. Therefore, the aim of our     randomized controlled trial is to examine the effect of telemedicine with and without     coaching in comparison to a control group on weight loss in overweight participants.   "
110672|NCT01837394|"     In this study, we wish to investigate the effect of ultrasound (US) -guided block of the     saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative     pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following     ambulatory knee arthroscopy.      We wish to investigate the analgesic effect of these two blocks compared to placebo     (injection of local anesthetic with known pain blocking properties compared with injection of     a saline solution), when used as a supplement to conventional oral analgesics.      We hypothesize that patients receiving the active treatment may experience less pain during     the first 24 hours after their operation than patients receiving the placebo treatment, and     possibly require less opioid analgesics, experience less opioid related side effects and have     a higher function level in this period than patients receiving the placebo treatment.   "
110673|NCT01837381|"     The objective of this trial was to evaluate the clinical outcome, treatment toxicity and     tumor response of TEA for unresectable HCC.   "
110674|NCT01837368|"     Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment of     quality of life and suffering in patients with tinnitus.      Association between experiencing, verbalizing and regulating emotions and perceived tinnitus.      Correlation analysis are used to search for connections between the subjective behavioral     outcomes mentioned above and the objective EEG-patterns.   "
110675|NCT01837355|"     Pulmonary inflammation is an independent risk factor for disease progression in cystic     fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental     inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several     inflammatory diseases. As children with CF have different faecal microbiota from their     healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation     might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy     control) will receive either placebo or lactobacillus rhamnosus once daily as dietary     supplementation for 12 weeks. After a one-week washout phase, they will be switched for     another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation     as well as clinical outcome will be studied.   "
110676|NCT01837342|"     Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A     person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and     infection sets in around the diverticulum the condition is called diverticulitis. An     individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and     fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent     hospitalisations as a result of the evolution of purulent peritonitis that originates from     diverticulitis treated by mini-invasive surgery results.      Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic     generalized purulent peritonitis of diverticular origin have been identified as therapeutic     options by HAS (French health authorities), followed by second stage resection-anastomosis     under elective surgery. It has been observed in patients that if only drainage and washing     are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are     much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore     this reduces the risks of postoperatory complications.      Some studies have shown that the attitude of non-distance resection of the acute episode was     associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity.     In addition, the morbidity associated with intervention sigmoid resection is around 30%.      The question arises in our daily practice, or not to propose systematic resection of sigmoid     diverticulitis after an acute episode of severe purulent peritonitis or abscess types     supported initially by minimally invasive.      The primary objective of the study is to determine, after clinical improvement linked to     conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if     a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as     currently recommended.      The secondary objective of the study is to determine if conservative treatment reduces     mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and     improves quality of life.   "
110677|NCT01837329|"     The main objective of this study is to determine recommended phase II dose and safety of     tetrathiomolybdate (TM) in combination with carboplatin and pemetrexed in chemo-naive     metastatic or recurrent non-squamous non-small cell lung cancer.   "
110678|NCT01837316|"     The study will be a randomized, double-blind, placebo controlled cross-over study in 32 adult     subjects with moderately severe asthma. In this study the bronchodilator effect of a single     morning dosing of FF/VI combination 100/25 mcg will be determined by spirometry. After the     screening the subject will be randomized and will be assigned to one of two treatment     sequences (AB or BA, where A is placebo and B is FF/VI 100/25 mcg). Between the two treatment     periods there will be a washout period of 7-14 days. A serial forced expiratory volume in one     second (FEV1) measurements will be taken at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and     72 hours post dose. Safety assessments will include vital signs, electrocardiograms (ECGs),     adverse event (AE) monitoring and laboratory safety tests however, these will not constitute     study endpoints. The results of the study will provide supporting information to prescribers     on the bronchodilator effect of FF/VI over 72 hours.   "
110679|NCT01837303|"     Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and     standard Thin prep cytology screening.      Participants: 100-120 healthy women presenting for standard pap smear screening      Procedures (methods): After routine care pap smear, another pap smear will be performed and     placed in the study medium. Clinical care pap and study pap will be reviewed by a single     pathologist to assess for equivalent findings.      Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.   "
110680|NCT01837290|"     Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to     osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an     increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be     required for geriatric patients with end stage renal disease. These patients have severe     comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the     perioperative period. For this reasons a careful anesthesia plan should be planned and     performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with     chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine     position with a fracture table. Intraoperative sedation might be necessary for patients under     regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist that is     being used as an agent for its sedative and adjuvant analgesic effects.      The aim of this study is to evaluate the effects of dexmedetomidine premedication on     geriatric patients with end stage renal disease, who will be undergoing a surgical operation     for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral     Index) guided sedation with intraoperative propofol infusion.   "
110692|NCT01837121|"     The purpose of this study is to use a randomized controlled design to determine the impact of     a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic     retinopathy in rural China.   "
110681|NCT01837277|"     The current available antiretroviral (ARV) agents make possible a successful treatment of     virtually all HIV-infected patients, but some problems related to early mortality are still     of concern, mainly in resources-limited settings. There are several published reports showing     that such patients are at a significantly higher risk of death during the first months of     treatment, in comparison with the observed outcomes in developed countries. One of the     consistently detected risks for early mortality across these reports is the baseline low CD4     count, although it does not seem to be the only reason for such outcome. In Brazil and other     developing countries, there is still a large proportion of AIDS patients who are diagnosed     with AIDS, or only seek health care for HIV infection late in the course of disease.     Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The     available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher     increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The     investigators propose to compare the impact of RAL versus EFV in the early mortality rates     for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.   "
110682|NCT01837264|"     Compartment syndrome (CS) is a condition resulting from increased pressure within a     compartment, which compromises circulation and can lead to critical limb ischemia. CS is one     of the biggest medical challenges that our soldiers face after battlefield related injuries.     Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute     compartment syndrome is a medical emergency requiring surgery. Treatment of compartment     syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to     evaluate the feasibility and safety of the administration of marrow-derived autologous bone     marrow concentrate and PRP gel generated by a point of care marrow separation system for the     treatment of compartment syndrome. And to show this treatment possibly enhances wound     healing, bone healing, perfusion, infection control, and the return of limb function in     patients with CS.      Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and     wound healing have predominantly focused on the mechanism of action of a single stem cell     population to achieve neovascularization and improve tissue perfusion. It is well documented     that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF,     bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's     development efforts focus on concentration of autologous bone marrow-derived stem cells and     platelets for delivery to the site of injury in a concentration sufficient to effect local     tissue revascularization and repair. These products provide for the rapid, bedside     preparation of autologous PRP and bone marrow stem cell concentrate.      This clinical trial with the Magellan® System is for the preparation of autologous cell     concentrate for the treatment of wound, tissue and bone healing, improved perfusion,     infection control, and the return of limb function in patients at risk of amputation.   "
110683|NCT01837251|"     Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer     when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and     PLD/carboplatin.   "
110684|NCT01837238|"     The purpose of this study is to examine the effect of 6 months of daily beta-hydroxy     beta-methylbutyrate (HMB) supplementation on the physical function and the health of bones,     arteries and heart in hemodialysis patients.   "
110685|NCT01837225|"     Breast cancer is the most commonly occurring cancer in women. Currently, breast conservation     surgery (BCS) is the treatment most often prescribed. BCS involves removing the tumor while     conserving the greatest amount of healthy breast tissue. Under standard white light, tumor     borders are difficult for the surgeons to visualize. Therefore, between 30-70% of patients     require a second operation to remove remaining cancerous tissue that wasn't detected during     the initial surgery. Thus, there is an urgent clinical need for a new imaging tool that     improves tumor visualization during the first surgery.      PRODIGI, a new hand-held optical imaging device, uses a safe violet-blue light to detect     fluorescence signals in the tissue. Different tissues are associated with specific     fluorescent colors and therefore the device can be used to differentiate between tumor and     healthy breast tissue. Based on previous clinical data, PRODIGI can distinguish some tumors     from normal tissues, but is not specific enough to detect a difference across all breast     tumor types.      The fluorescent contrast drug 5-aminolevulinic acid (5-ALA) accumulates in tumors naturally     and previous research has shown that 5-ALA increases tumor-normal tissue fluorescence     contrast. In this observational clinical study, PRODIGI and 5-ALA will be used to visualize     tumor borders during BCS. 5-ALA induced fluorescent images from the surgical sample and the     surgical bed obtained by PRODIGI will be compared retrospectively with the images taken under     standard white light and/or autofluorescence. The technology's ability to accurately identify     tumor borders better than conventional practice will be confirmed by tissue pathology.   "
110686|NCT01837199|"     Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX) and     metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and     microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with     ChP. However, the effects of this antibiotic protocol have not been directly compared in     non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical and     microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and non-smokers     subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers would benefit     better from this combination of therapies than the smokers.   "
110687|NCT01837186|"     Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem     that occurs in about 2% of pneumonectomy patients.   "
110688|NCT01837173|"     It is well known that lymph node metastasis is one of the most important prognostic factors     in oesophageal carcinoma.      The investigators want to determine the influence of lymph node characteristics, being either     intracapsular or extracapsular, on overall survival after esophagectomy for esophageal     cancer.   "
110689|NCT01837160|"     Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible     for cardiovascular disease. In this proposal, the investigators intend to build upon a highly     successful programme of studies exploring the cardiovascular applications of positron     emission tomography. Specifically, the investigators will explore the potential role of a     novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and αvβ5     integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and     remodelling. This tracer has been successfully used to assess angiogenesis in metastatic     tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here     propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases,     specifically aortic stenosis and aortic atherosclerosis. The investigators will correlate     18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis as well as ex vivo     histological characterisation of tissue. If successful, this novel radiotracer could provide     an extremely important non-invasive method of assessing in vivo angiogenesis, plaque     vulnerability, and tissue remodelling as well as potential applications in developing stem     cell therapies.   "
110693|NCT01837108|"     Various studies have reported cardioprotective effects of mineralocorticoid receptor (MR)     antagonists in the setting of an acute myocardial infarction. In a recent animal study, the     protective effect of MR antagonists on infarct size was completely abolished in CD73     knock-out and adenosine A2b receptor knock-out mice, and by co-administration of adenosine     receptor antagonists in rats. These findings suggest that extracellular formation of     adenosine is crucial for this protective effect and that MR antagonists stimulate     extracellular adenosine formation by the enzyme CD73.      To investigate whether eplerenone promotes adenosine receptor stimulation by activating CD73,     the investigators will measure forearm blood flow in response to various dosages of     dipyridamole with the use of plethysmography. Dipyridamole increases the extracellular     endogenous adenosine concentration by inhibition of the ENT transporter and induces local     vasodilation. Therefore, the vasodilator effect of dipyridamole accurately reflects     extracellular adenosine formation by the CD73 enzyme.   "
110694|NCT01837095|"     POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to,     on the day of and on days after treatment with eribulin. Different doses and dosing     frequencies will be investigated   "
110695|NCT01837082|"     The hypothesis to be tested is whether treatment with intravenous iron (ferric     carboxymaltose) will improve left-ventricular ejection fraction in patients with heart     failure and iron deficiency as determined by cardiac magnetic resonance imaging.   "
110696|NCT01837069|"     This trial is designed to determine the best preoperative management strategy for patients     undergoing orthopedic surgery.   "
110697|NCT01837056|"     Investigate the prevalence of Toxoplasma gondii and Toxocara canis in Uveitis        -  serum antibody to T. gondii and T. canis        -  PCR with peripheral blood for T. gondii and T. canis        -  PCR with aqueous humor for T. gondii and T. canis        -  Clinical manifestation of patient with uveitis   "
110698|NCT01837043|"     The purpose of this study is to evaluate the safety and efficacy of conversion from a     calcineurin inhibitor (tacrolimus or cyclosporine) immunosuppression therapy to Nulojix®     (belatacept) immunosuppression therapy in patients with delayed (DGF) or slow graft function     (SGF) following kidney transplantation. Patients at risk for SGF or DGF will be consented at     the time of kidney transplantation. On post-op Day 5 the patient will be assessed, if they     have developed SGF or DGF they will be randomized to convert to Belatacept or continue on     their CNI regimen. Up to 20 subjects who do not develop DGF will be followed as control     subjects. Seventy randomized subjects will be followed for a total of 14 months with a renal     biopsy at Month 12 post transplant.      Research Hypotheses:      Primary Hypotheses:        -  Kidneys with slow or delayed graft function are more susceptible to acute and long-term          CNI toxicity        -  Kidneys converted from calcineurin inhibitor based therapy to belatacept will achieve a          more rapid recovery from post-ischemic acute tubular necrosis (ATN) and will have          improved 1 year calculated GFR.      Key Secondary Hypotheses:        -  Renal Histology: Belatacept converted patients will have a lower chronic allograft          damage index (CADI) score and lower interstitial fibrosis and tubular atrophy (IF/TA)          score as calculated by Banff criteria at 1 year post- transplant        -  Biomarker Analysis: Biomarker analysis (clusterin) measured in serial urine collections          can 1) directly assess CNI induced kidney injury and 2) improve the prediction of          patients that benefit in early belatacept conversion.   "
110699|NCT01837030|"     This study is a single center prospective randomized control trial comparing the utility of     performing capsule endoscopy compared to conservative management with oral iron therapy as     the initial course of action in patients with non-severe obscure occult or obscure overt     gastrointestinal (GI) bleeding. The investigators hypothesize that outcomes in patients with     non-severe obscure GI bleeding who receive conservative therapy with oral iron will not     differ to those on oral iron who undergo capsule endoscopy.   "
110700|NCT01837017|"     Over half of persons with multiple sclerosis (MS) report falling over a 6-month period and a     majority of those who fall require medical attention for injuries. Importantly, balance     dysfunction, muscle weakness, and spasticity are modifiable risk factors for falls among     community-dwelling older adults and likely persons with MS. Indeed, there is evidence that     these physiological risk factors can be minimized with exercise training in persons with MS     and this might translate into a decrease in fall risk as documented in community-dwelling     older adults.      The investigation will examine the effectiveness of a home-based exercise program that is     designed to reduce fall risk by targeting specific fall risk factors including balance     dysfunction and two of its latent causes, muscle weakness and spasticity in persons with     multiple sclerosis. It is predicted that persons who receive home-based exercise program will     have a reduction in fall risk.   "
110701|NCT01837004|"     The purpose of this study is to compare CORTEX (Cognitive Regulation Training and Exercise),     a multi-faceted, general and exercise-specific cognitive training program plus a 4-month     exercise program, to an attention-control condition involving health and wellness     informational lectures plus videos. The proposed exercise program will involve both aerobic     and resistive exercises. The investigators hypothesize that pre-intervention cognitive     training will enhance self-regulation and self-efficacy and in turn, increase exercise     adherence. The investigators also expect more positive improvements in cognitive and     psychosocial function among participants in the CORTEX condition as compared to the Control     condition immediately following the cognitive booster training, and across time.   "
110702|NCT01836991|"     The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical     surgery for the treatment of advanced distal gastric cancer.   "
110703|NCT01836978|"     The process of enhancing the functional capacity of an individual before an operation to     enable him or her to withstand the stress of surgery has been termed prehabilitation. It has     been shown that poor baseline capacity for physical performance and poor nutritional status     increase the risk of complications after major non cardiac surgery and prolong recovery. A     controlled randomized study in patients undergoing radical cystectomy for cancer is therefore     proposed to determine the impact of multimodal prehabilitation on functional exercise     capacity and functional recovery. Patients who accept to be enrolled in the study will be     randomized to either a group receiving a multimodal intervention which includes nutritional     supplementation (Immunocal® whey protein) combined with a physical exercise program and     stress reduction strategies before and after surgery, or a control group who will receive     standard preoperative treatment as per our institution.   "
110704|NCT01836965|"     The objective of this study is to validate a social skills training program manual for     adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately     150 adolescents with autism spectrum disorders will participate in this study, in groups     consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both     group therapy and peer generalization sessions (in the form of a photography class) once a     week over the course of twelve weeks. Participants and their parents will complete paper and     pencil, online, or phone measures and video-recordings to assess the participant's social     skills prior to the intervention, at completion of the intervention and three months later.   "
110705|NCT01836952|"     Dietary and oral hygiene habits are known to affect oral microorganisms and disease     incidence, but most research has focused on preschool aged (2-4 yr old) children. A recent     experiment in our lab demonstrated a highly diverse oral microbiome in the saliva of infants     without teeth (3-6 months old). These data suggest that soft tissues in the mouth serve as a     reservoir for pathogens and must be considered in oral health management. The evolution of     microorganisms that occurs between birth and tooth eruption has not been characterized and     may have great implications as it pertains to oral disease later in life. The investigators     are interested in determining how dietary changes during this time affect oral microbiota.     Tongue and cheek swab samples will be collected from a small cohort of infants (n=20) at 4     time points. At the same time, a survey and 3 day feeding diary of the infant's diet will be     collected. In addition, a pregnancy survey and food frequency questionnaire will be     administered at the time of recruitment. Research staff will conduct a 10-minute interview at     the first and last oral sample collection time. These pilot data will provide important     diet-oral microbe relationships in edentulous infants, allowing us to propose and test     specific hypotheses pertaining to diet, oral microbes, and disease in young children.   "
110706|NCT01836939|"     The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris     suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.   "
110707|NCT01836926|"     The two surgical options for lower 1/3 rectal cancer is APR and sphincter sparing procedures.     Intersphincteric resection is procedure to treat very low rectal cancer within 2 cm from the     dentate line to avoid permanent colostomy,improves the quality of life with better     genitourinary function. Neoadjuvant chemo-radiotherapy is routine for T3 cases.   "
110708|NCT01836913|"     The RESPECT study is intended to prospectively assess the impact of PET/CT on the delineation     of target volumes and to estimate the proportion of recurrences that could possibly be     prevented by the use of PET/CT-based target volume, instead of CT-based. Patients will     recieve radiotherapy using CT-based planning, but a PET/CT-based treatment plan will also be     made. CT-based and PET/CT-based target volumes will be compared after treatment has been     completed. If a locoregional recurrence takes place, the localisation will be compared to the     CT-based and PET/CT based clinical target volumes (CTVs). If the local recurrence is located     outside the CT-CTV but inside the PET/CT-CTV, the recurrence could possibly have been     prevented with PET/CT-based radiotherapy.   "
110709|NCT01836900|"     Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are     randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic     standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy     regarding technical success and rebleeding.   "
110710|NCT01836887|"     The purpose of this study is to determine whether consumption of the active product affects     postprandial changes in metabolic indices, in comparison to the control product.   "
110711|NCT01836874|"     The purpose of this study is to evaluate the safety and effectiveness of topiramate in     preventing migraine among Indian participants requiring prophylaxis (measure taken to     maintain health and prevent the spread of disease).   "
110712|NCT01836861|"     This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME)     and absolute bioavailability study in 6 healthy adult male subjects.   "
110713|NCT01836848|"     The purpose of this study is to show if it is possible to detect secondary ischemic events in     patients with severe brain injury or cerebral haemorrhage with the help of non-invasive     near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral     perfusion.   "
110714|NCT01836835|"     Nausea in early pregnancy (emesis gravidarum) is very common but most often self-limiting.     Hyperemesis gravidarum; where nausea and vomiting is severe and protracted is potentially     dangerous for the woman and her foetus and necessitates hospital treatment. An English     questionnaire (PUQE; Pregnancy Unique Questionnaire of Emesis) exists that can differentiate     between uncomplicated emesis and the severe hyperemesis condition. This questionnaire has     been translated to Norwegian. The investigators want to test the ability of this     questionnaire to differentiate the grade of nausea/vomiting between a group of presumed     normal pregnant woman and patients treated for hyperemesis gravidarum in a Norwegian     population. The investigators also want to relate the PUQE questionnaire scoring to the     women/patients' self-reported nutritional intake during 24 hours.   "
110715|NCT01836822|"     The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle     aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal     lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are     considered insufficient and histological sampling is preferred. The aim of the study is to     compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to     obtain histological samples from MLN in patients with clinical and radiological features of     sarcoidosis.      Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps     biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy     will be performed in 90 consecutive patients with mediastinal lymph node enlargement and     clinical and radiological features of sarcoidosis.      Diagnostic accuracy of each sampling technique will be calculated and compared to other     techniques. Diagnostic yield of different technique combinations will also be calculated and     the most efficient diagnostic approach will be defined.   "
110748|NCT01836393|"     To determine whether plai cream is effective in treating mild to moderate degrees of     osteoarthritis of the knee in the elderly patient compared with placebo cream.   "
119397|NCT01723098|"     The main aim of this study was to analysed the security of a supervised exercise program on     maternal cardiovascular system and assess the positive effects of this program on maternal     cardiovascular function and structure   "
110716|NCT01836809|"     The prevalence of renal dysfunction after implantation of the artificial heart is high. The     infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total     artificial heart (TAH) improves renal function in a sustained manner. The renal protective     and hormone-modulating effects of nesiritide may be enhanced with ventriculectomy compared to     heart failure surgery that leaves the native myocardium intact. The goal of this project is     to determine the renal protective effects of nesiritide after implantation of a mechanical     device.   "
110717|NCT01836796|"     Recent data suggest that the trillions of bacteria in gastrointestinal tracts (gut     microbiota) can function as an environmental factor that modulates the amount of body fat.     Obese individuals have an altered gut microbiota and germ-free mice are resistant to     developing diet-induced obesity and have lower fasting insulin and glucose concentrations and     shows an improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus     Gasseri SBT2055 in fermented milk for 12 weeks reduced adiposity and body weight in obese     adults possibly by reducing lipid absorption and inflammatory status. However, there are no     controlled studies to the investigators knowledge that address whether probiotic     supplementation affects glucose metabolism. The investigators hypothesis is that     supplementation of Lactobacillus reuteri DSM 17938 may improve metabolic control in type 2     diabetes patients. In addition, the investigators will explore possible mechanisms behind the     antihyperglycemic action of Lactobacillus Reuteri.   "
110718|NCT01836783|"     The study will compare the density and strength of regenerated bone in extraction sockets     after being grafted with two different materials: Bone Allograft and Bone Allograft with     Amnion.      The investigators hypothesize that sockets grafted with the Amnion graft will exhibit     enhanced healing patterns and will accelerate the formation of regenerated bone in the     grafted areas.   "
110719|NCT01836770|"     The purpose of this study is to describe the contrast flow patterns in the epidural space     using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how     well this approach correlates with appropriate contrast flow patterns and with analgesia at     follow up. This knowledge may prove useful in guiding physician practice patterns in the     non-surgical management of low back pain.      Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior)     epidural contrast spread based on inferior-anterior needle-tip position, particularly with     appropriate needle tip position.   "
110720|NCT01836757|"     To delineate the effect of MSM on osteoarthritis   "
110721|NCT01836744|"     Previous in a randomized way, it will be performance 12 bilateral sinus lift with autologous     bone in one side and the in other with xenograft material. After 6 mouths we will place 1 to     3 implants in each side and analyse the survival rate and possibles differences related to;     prosthesis failure; biological and prosthetic complications; peri-implant marginal bone level     changes.   "
110722|NCT01836731|"     Community Health Clubs to improve local sanitation, hygiene and health conditions have been     implemented in several countries in Africa and Asia with some success. The Ministry of Health     in Rwanda has committed to rolling out a program designed along similar lines, the Community     Based Environmental Health Promotion Program (CBEHPP), in all 15000 villages across Rwanda.     The main objective of the program is to achieve 'zero open defecation' in all villages of     Rwanda, at least 80% hygienic latrine coverage and improvements in a range of health     behaviors such as the use of mosquito nets, hand-washing with soap and the use of household     water treatment.      To evaluate the impact of the program on health, other socio-economic outcomes and community     functioning, a single district has been chosen where 150 communities will be randomized to     receive the intervention immediately or 18 months later. The evaluation is led by US based     Innovation for Poverty Action (IPA) through researchers based at the National University of     Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York     University. The research team will work in close collaboration with the implementing team,     which consists of the Ministry of Health, Rwanda and Africa AHEAD.      The study will span three years, beginning in May 2013, and ending in late 2015.   "
110723|NCT01836718|"     The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver     transplantation in patients receiving antiviral therapy while on the liver transplant waiting     list. This will eventually be correlated with the degree of hepatic fibrosis present within     different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the     patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver     at the time of transplantation, the explant will be biopsied multiple times in different     segments of the liver and preserved for viral detection studies as well as analysis of the     degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral     detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1     month, 3 months and 6 months post liver transplantation.      Study Hypotheses:        -  Virological relapse or non-response is higher is patients with cirrhosis due to failure          of antiviral medication to concentrate adequately in a fibrotic liver having an altered          sinusoidal micro-architecture        -  HCV may persist in different geographic regions of the fibrotic liver in part predicated          on blood supply to that area and this may have an effect on overall virological          response. These differences in viral persistence and detection may exist in different          lobes of the liver or even within a few centimeters within the same portion of the liver          parenchyma.        -  PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in          patients receiving antiviral therapy and may account for virological relapse          post-therapy        -  There may be varying degrees of fibrosis within the same cirrhotic liver which may          impact on hepatic synthetic function and antiviral response to treatment.   "
110724|NCT01836705|"     Primary Objective:      - To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the     QTcF interval compared to 1-day placebo in patients with advanced solid tumors.      Secondary Objectives:        -  To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate          (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo.        -  To assess the clinical and laboratory safety of SAR302503        -  To document the plasma concentrations of SAR302503 at the time of ECG investigation.        -  To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503          concentration and QTcF        -  To explore antitumor activity   "
110749|NCT01836380|"     Hypothesis #1: The investigators hypothesize that both swimming training and cycling training     will demonstrate significant improvements in endothelium-mediated vasodilation and central     artery compliance in this population and that there will be no difference in the magnitude of     increases between the water-based and land-based exercise interventions.      Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent     vasodilation and arterial compliance in response to exercise training interventions will be     related to the corresponding reductions in inflammatory biomarkers.      Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling exercise     will improve functional capacities and disease progression in middle-aged and older adults     with osteoarthritis.   "
110725|NCT01836692|"     This study is for patients having a course of chest radiotherapy treatment after receiving     chemotherapy for the treatment of non-small cell lung cancer. Patients with non-small cell     lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.      In this study, we will investigate:        -  whether giving a more targeted and individualised type of chest irradiation or          radiotherapy to the lung tumour (known as Isotoxic IMRT), is practical and whether it          causes side effects which can be tolerated        -  whether this new method of delivering the radiotherapy can reduce the risk of the tumour          in the lung recurring or progressing        -  whether survival can be improved by using this new radiotherapy method      The dose of chest irradiation will be calculated specifically to suit patient's body shape,     the position of the lung cancer, and how close healthy tissues are to the tumour.     Radiotherapy will be delivered twice a day over a maximum period of 4.5 weeks. The duration     of treatment will vary individually according to the delivered dose to the tumour area.   "
110726|NCT01836679|"     The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with     paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.   "
110727|NCT01836666|"     How are the health related quality of life among patients with chronic pain effected by     interventional pain managment?      Hypothesis:      Health related quality of life can be improved by interventional pain management both among     patients with localizable pain focuses and among patients among whom no pain focuses can be     found.      Method:      Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the     time of treatment for pain focuses an during the following 12 months.   "
110728|NCT01836653|"     The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and     mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol     1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.   "
110729|NCT01836640|"     There are three major subtypes of breast cancer:        1. Hormone receptor positive (contain cells that express the estrogen receptor or          progesterone receptor).        2. Tumors that express the epidermal growth factor receptor gene ( HER-2)        3. Triple negative (cancer cells that lack the hormone receptors and the epidermal growth          factor receptor gene HER-2.      While effective therapies exist for most cases of breast cancer at first occurrence, many     patients eventually exhibit disease that does not respond to all standard breast therapies,     particularly in the metastatic setting.      There are therapies that are used to treat other types of cancers with genetic mutations that     are in the process of being evaluated for use in breast cancer. The current techniques used     for detecting mutations in the genes of breast cancer patients, which can be treated with     drugs specific for the genetic mutations, are invasive and identifying effective diagnostic     non-invasive procedures are the next challenge for physicians. This study will compare the     ability to detect genetic mutations samples from non-invasive procedures such as a blood     draw, to more invasive procedures such as tissue taken from a biopsy sample.      There is also a concern with current techniques used to detect genetic mutations that cells     from a single tissue sample may not be representative of the types of cells present in all     the tumors in the body and therapies selected using a single tissue sample may not be     effective for all of the cancer in the body. This study will use blood drawn from     participants prior to any drug therapy and compare the genes from this blood to tissue     samples from multiple sites of disease.      The study will also compare the genetic profile of the metastatic tumors to the genetic     profile of the original breast cancer to determine if there are any changes in the genetics     of the tumor cells.      The participants that have newly diagnosed metastatic disease will provide tissue from their     primary site of disease via an image guided biopsy. These participants will also provide     tissue from at least 2 other distant metastatic sites (lung, pleural/peritoneal, liver,     brain, or skin). Each biopsy procedure will attempt to obtain 2-3 samples for research     purposes.      Participants that have locally recurrent disease in the breast will have the tissue from the     site of re-occurrence biopsied as well as two distant metastatic sites (lung,     pleural/peritoneal, liver, brain, or skin). Participants that have either multi-centric     disease or bilateral disease will have all tumors sampled with the intention of providing 2-3     samples/tumor for research purposes. Participants with multi-centric and bilateral disease     will also have 2 distant sites of distant disease sampled (lung, pleural/peritoneal, liver,     brain, or skin).      Prior to any scheduled biopsy procedures all participants will have a blood draw used to     examine the genetics of the tumor cells in the blood. The participants will have 8 tubes of     blood drawn for the test and then they will proceed onto the tissue sampling portion of the     study.   "
110730|NCT01836627|"     This research study includes children ages 5 to 20 years old with Collagen Type 6 Congenital     Muscular Dystrophy or Laminin α2-related muscular dystrophy (LAMA2-MD). The goal of this     study is to measure the effect of breathing exercise to stretch the chest in slowing the loss     of breathing function. The breathing stretches are done with a machine called Cough Assist®.      The study is being done at Cincinnati Children's Hospital Medical Center and Children's     Hospital of Philadelphia. The study involves traveling to one of these 2 centers for 4 visits     over 13 months. The study also includes 3 sets of phone visits called Daily Phone Diaries.      Participants will be randomized into one of 2 study groups in a 1:1 ratio. The treatment     group will use the Cough Assist® machine twice a day for 15 minutes. The control group will     continue with their current daily care. The Cough Assist® is a machine that blows air into     the lungs (insufflation) and helps pull air out of the lungs. The investigators will be     blowing enough air into the lungs to cause a stretch to the chest. This is called     hyperinsufflation.      Study visits will last about 5 to 6 hours and will include medical and quality of life     questionnaires and pulmonary function tests to determine lung function and the individualized     settings to be prescribed for the Cough Assist®.   "
110731|NCT01836614|"     The purpose of this study is to determine if an intravenous lidocaine infusion (compared to     placebo) intraoperatively will decrease time to return of bowel function postoperatively,     decrease postoperative pain, diminish postoperative opioid requirement, minimize inflammatory     markers and shorten time to discharge after colorectal surgery.   "
110732|NCT01836601|"     This study seeks to determine whether a family-centered nighttime communication intervention     improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric     patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of     nighttime medical care.   "
110733|NCT01836588|"     It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix     will bring the same conclusion than the conventional cervix biopsy, but with less pain and     morbidity, after patients were undergoing a conisation in order to treat CIN.   "
110767|NCT01836133|"     This multicenter, observational study will evaluate the efficacy and safety of Tarceva     (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell     lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva     according to the Summary of Product Characteristics and local label will be followed for the     duration of their treatment.   "
110768|NCT01836120|"     A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in     subjects with Gastric Cancer.The purpose of this study is to compare the activity of     Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with     gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.   "
110934|NCT01833923|"     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,     Ltd.      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and     VEGFR3. It has the obvious resistance to new angiogenesis.   "
110734|NCT01836575|"     Optimal management of patients with advanced NSCLC and with PS 2 remains controversial and     underrepresented in clinical trials, typically accounting for 5 to 10% of enrolled patients.     Patient PS 2 proportion in population-based studies is considerably higher than that included     in clinical trials. Management of patients with PS of 2 in clinical practice is empirical and     inconsistent. Patients have median overall survival of 3 to 5 months in randomized trials,     and treatment options include best supportive care, single-agent and combination     chemotherapy. Retrospective studies have suggested that patients PS 2 may benefit from     first-line chemotherapy in terms of symptom improvement and overall survival. In many of     these studies, single-agent chemotherapy was compared with best supportive care alone. Data     on the role of cisplatin-based combinations for patients with PS 2 is more scant, with one     study questioning its benefit, and another interrupting accrual because of undue toxicity.     With regards to carboplatin, the Cancer and Leukemia Group B (CALGB) study 9730 compared     paclitaxel plus carboplatin versus paclitaxel alone in a subgroup of 107 patients with PS 2;     the median overall survival was significantly longer in group treated with combination     chemotherapy (4.7 versus 2.4 months). Combination chemotherapy with carboplatin and     paclitaxel also produced a statistically significantly higher incidence of severe     hematological and non-hematological toxicities. On the basis of aforementioned results, a     recent European panel stated that carboplatin-based or low-dose cisplatin-based doublets     might represent alternative options to single-agent chemoterapy in patients PS 2. Outside     clinical trials, single-agent chemotherapy with a 3rd generation agent remains valid option     for patients PS2. Results demonstrate that pemetrexed is an agent with established     single-agent activity in NSCLC, and suggest it is a potential candidate for combinations with     platinum and other agents currently utilized for patients with advanced NSCLC. Favorable     toxicity profile of pemetrexed suggests that this agent is an ideal candidate for single     agent testing and in combination among patients with PS 2. Substantial doubt remains in the     comparative benefit from monotherapy versus combination. Starting dose and schedule of     pemetrexed were set for this study based on its current labeling in the 2nd line treatment of     metastatic NSCLC and 1st line treatment of malignant pleural mesothelioma.   "
110735|NCT01836562|"     This clinical trial is a single Arm, single centre to check the safety and efficacy of bone     marrow derived autologous mono nuclear cells (MNC) (100 million per dose). Trial to be     conducted for 36 months.   "
110736|NCT01836549|"     This molecular biology and phase II trial studies how well imetelstat sodium works in     treating younger patients with recurrent or refractory brain tumors. Imetelstat sodium may     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
110737|NCT01836536|"     Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an     antiangiogenic treatment currently proposed to recurrent high grade glioma patients.     Unfortunately some patients fail to respond to this treatment and finding biological factors     allowing the discrimination between potential responders and non responders would be very     helpful. As the immune system plays a key role in angiogenesis induction and maintenance in     cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.      The purpose of this study is to determine the influence of bevacizumab treatment on     circulating immune cells in high grade glioma patients and to search for a link between the     variation of these cells and the response to treatment.   "
110738|NCT01836523|"     This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety     of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total     trial duration per subject is approximately 58 weeks.   "
110739|NCT01836510|"     Multicentre study with the objective to correlate heart failure hospitalizations and deaths     with Home Monitoring data in ICD/CRT-D recipients, in order to identify the combination of     Home Monitoring data with the greatest sensitivity and specificity in predicting Heart     Failure events.      All data are prospectively collected.   "
110740|NCT01836497|"     The study is designed to confirm safety and efficacy of the SD01 ICD (implantable     cardioverter-defibrillator) lead.   "
110742|NCT01836471|"     The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics     taking low dose Inhaled Corticosteroid (ICS) as background therapy.   "
110743|NCT01836458|"     This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male     patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single     dosing with KAE609   "
110744|NCT01836445|"     Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all     young people in the U.S. and are alone in facing an increasing rate of infections. Because     YMSM are less likely to receive relevant sexual health education in traditional settings     (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.      The purpose of this study is to compare two different versions of an online HIV prevention     program for YMSM. The study is being conducted by researchers at Northwestern University in     Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900     YMSM will be enrolled into this study from the clinics of community partners in Chicago, New     York, and Atlanta.      Participants will be randomly assigned to one of two versions of the program. Some topics in     the program include HIV facts and myths, sexually transmitted infections (STIs), and condom     use. All participants, regardless of the program version they receive, will also take at-home     urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program,     participants will be contacted three more times over the course of a year for follow-up     sessions and surveys.      The research team hypothesizes that the YMSM-specific prevention program will lead to a     significant reduction in the frequency of unprotected anal sex acts and new STI infections     compared to the HIV knowledge program that is for a general audience. The YMSM-specific     program will also lead to improvements in secondary knowledge, motivation, and skills     outcomes.      In order for the research team to measure the effectiveness of the YMSM-specific prevention     program and determine if the study hypothesis is correct, participants will be asked     questions about themselves, including questions about their sexual orientation, sexual     experiences, health practices, including drug use, health knowledge, and questions about     their feelings and emotions. Based on this information, the research team hopes to later     change, improve, or expand the program to better address the needs of YMSM.   "
110745|NCT01836432|"     Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most     patients diagnosed with pancreatic cancer continue to die from the rapid progression of their     disease. One primary reason for this is that the disease is typically without symptoms until     significant local and/or distant spread has occurred and is often beyond the chance for cure     at the time of the diagnosis. The lack of any treatment to substantially increase long term     survival rates is reflected by the poor outcomes associated with this disease, specifically     time to disease progression and overall survival.      However, another important part of the body is now being looked at as a target for therapy     against this disease - the immune system. Scientists have clearly shown that pancreatic tumor     cells produce a number of defective proteins, or express normal proteins in highly     uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause     an immune response to the cancer cells much in the way one responds to infected tissue. In     progressive cancers however, the immune system fails to effectively identify or respond to     these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet     fully understood. This clinical trial proposes a new way to stimulate the immune system to     recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks     the growth of the cancer.      This new method of treatment helps the immune system of pancreatic cancer patients to     identify the cancerous tissue so that it can be eliminated from the body. As an example,     most people are aware that patients with certain diseases may require an organ transplant to     replace a damaged kidney or heart. After receiving their transplant, these patients receive     special drugs because they are at great danger of having an immune response that destroys or     rejects the transplanted organ. This rejection occurs when their immune system responds     to differences between the cells of the transplanted organ and their own immune system by     attacking the foreign tissue in the same way as it would attack infected tissue. When the     differences between foreign tissues and the patient's body are even larger, as with the     differences between organs from different species, the rejection is very rapid, highly     destructive, and the immunity it generates is longlasting. This is called hyperacute     rejection and the medicine used to immunize patients in this protocol tries to harness this     response to teach a patient's immune system to fight their pancreatic cancer just as the body     would learn to reject a transplanted organ from an animal.      To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that contain     a mouse gene that marks the cancer cells as foreign to patient's immune systems. The immune     system therefore attacks these cancer cells just as they would attack any truly foreign     tissue, destroying as much as it can. Additionally, the immune system is stimulated to     identify differences (aside from the mouse gene) between these cancer cells and normal human     tissue as foreign. This education of the immune system helps treat the patient because     pancreatic cancer cells already present in a treated patient are believed to show some of the     same differences from normal tissue as the modified pancreatic cancer cells in the product.     Due to these similarities, the immune system, once educated by the Algenpantucel-L     immunotherapy, identifies the patient's cancer as foreign and attacks.      The chemotherapy combination to be used in this study has been shown to improve survival in     advanced pancreatic cancer and is being combined with an experimental pancreatic cancer     immunotherapy that stimulates the immune system to recognize and attack the cancer. One goal     of this study is to determine whether chemotherapy and immunotherapies can work cooperatively     to increase anti-tumor effects to levels beyond what would be seen with either treatment     alone.      In this experimental study, all patients are given a strong combination of anti-tumor     chemotherapies while some patients are also given injections of an immunotherapy drug     consisting of two types of pancreatic cancer cells that we have modified to make them more     easily recognized and attacked by the immune system. We propose to test this new treatment     protocol in patients with locally advanced pancreatic cancer to demonstrate that treatment     with the immunotherapy increases the time until the tumor progresses or increases overall     survival when given in combination with the current standard of care therapy for this     disease.   "
110746|NCT01836419|"     There are some differences between elderly and young adult patients regarding the anatomy of     upper airways. Elderly patients have larger upper airways than young adult patients at all     pharyngeal levels as revealed by CT. Another study explained that there is a progressive     descent of the larynx and epiglottis with aging, which lengthens the upper airway and     possibly makes it more likely to collapse.      The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in     elderly patients with young adults. In this study, the investigators will measure the ease of     insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure,     gastric leak pressure, fiberoptic position and intraoperative complications of the classic     LMA.   "
110747|NCT01836406|"     Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with     clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney.     Interruption of renal blood flow via pedicle clamping is often necessary during partial     nephrectomy, especially for complex tumors with deep parenchymal invasion.     Ischemia-reperfusion injury is a complex process involving several mechanisms including renal     vasoconstriction, extensive tubular damage and glomerular injury. The investigators will     examine the postoperative renal function of patients who received intraoperative ketorolac     and remote ischemic preconditioning during partial nephrectomy.   "
110895|NCT01834430|"     Different studies suggest that early enteral nutrition (EEN) has benefits in reducing     infectious complications, there is no data that addresses whether delayed enteral nutrition     (EN) is detrimental and if it may have effects on inflammatory responses and immune function.   "
110750|NCT01836367|"     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some     consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for     the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage,     topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for     therapy, however as with other lesion-directed therapies, cryosurgery does not treat     subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the     sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been     approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide an     effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel 0.015%     has shown to not only have a high clearance rate but also a transient localized inflammatory     skin response that resolves quickly without sequelae. However, one common fear about ingenol     mebutate is that it's mechanism of action is purely destructive to both AKs and healthy skin,     and that retreatment would produce an equally, if not more, caustic result on the skin such     as severe erosion, scaling, and erythema. It is our hope to debunk this misconception and     demonstrate that reapplication of a second cycle of ingenol mebutate would result in lower     LSR scores compared to the LSR in the first cycle of application. We plan to treat 20     subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2     treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol     mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be     started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days     regimen for both cycles.   "
110751|NCT01836354|"     DESERVE is a discharge education study using health workers to enroll and randomly assign 800     subjects diagnosed with TIA, or mild stroke to either risk factor education or usual care.     Those patients assigned to education will receive stroke preparedness education plus risk     factor reduction education, and help accessing follow up care with health workers. Those     patients assigned to usual care will receive written stroke preparedness education. This     protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and     individual stroke risk factors and future stroke risk.   "
110752|NCT01836341|"     The purpose of this Phase I study is to test the safety of combining afatinib with standard     chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and     radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This     study will then test the safety of afatinib at different dose levels when combined with the     chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given     during radiation treatment and the drug afatinib will be continued after chemotherapy and     radiation.   "
110753|NCT01836328|"     The majority of current studies regarding the use of methadone (MTD) in the treatment of     cancer pain are focused in its administration via the oral route (PO). The ratio considered     from VO to parenteral route (BP) is 2:1. Academic literature assumes the ratio from BP to VO     to be 1:2. In our unit, we use MTD in the context of ROP and not as the last opioid. If face     with a situation where there is a good control of pain with MTD BP, usually we move to VO. We     have observed that the traditional ratio tend to produce certain toxicity problems. Because     of this, we have proposed a new ratio of conversion from PAR MTD to oral MTD, i.e. 1:1.2   "
110754|NCT01836315|"     Hypothesis: The investigators propose that obese parturients will have an increased     inflammatory response and a decreased anti-inflammatory response to the surgical and     anesthetic insult of caesarean section and that this will be associated with a higher rate of     perioperative complications, as compared to non-obese parturients.2 Background: Obese     patients exhibit higher levels of inflammatory markers than non-obese patients. Furthermore,     obese patients have a higher incidence of perioperative complications, especially wound     infections, and this is well documented in the caesarean section population. The pregnant     population is unique as a result of the immunologic changes that occur at baseline, and an     increase in pro-inflammatory markers is seen in serum and in placental tissue of obese     subjects, and has been demonstrated to correlate with adverse fetal outcomes.      Specific Objectives: To determine the baseline levels of three established markers of     inflammation in term pregnant obese and non-obese patients (defined by a BMI > and < 35 kg/M2     respectively), and examine how they change in response to the stress of surgery/anesthesia.     The investigators will correlate the inflammatory response with the incidence of     postoperative wound infections.      Methods: Patients will be recruited to the study prior to the planned caesarean section.     Blood samples for inflammatory marker levels will be performed preoperatively, immediately     postoperatively, and at 24 hours postoperatively. Samples will be analyzed for pentraxin-3 (a     relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and clinically     relevant inflammatory marker), and interleukin-10 (IL-10) (an established anti-inflammatory     marker). Plasma will be analyzed by ELISA to determine levels of each biomarker. Patient     charts will be reviewed to determine which patients have experienced surgical complications     in the 30 days postoperatively. Surgical complications will then be correlated with the     measured levels of inflammatory markers.      Assuming that the levels of inflammatory cytokines in obese patients will be 15% higher in     obese parturients and assuming an alpha error level of 5% and a beta error level of 20%, the     investigators would need to study 18 patients per group to prove our hypothesis that     inflammatory cytokine levels are correlated with postoperative infections. The investigators     plan to study 20 patients per group to account for a potential patient attrition rate of 10%     during the study.      Significance/Importance: The connection between obesity and dysregulation of the     perioperative inflammatory response has not been well established nor has perioperative     inflammation in the obese population been linked to the observed increased in perioperative     morbidity. The investigators hope to demonstrate these connections and hopefully will be able     to identify at risk patients earlier, and in a subsequent study intervene to reduce the risk     of postoperative wound infections with pharmacokinetically targeted antimicrobial     prophylaxis.   "
110755|NCT01836302|"     Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A     potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is     associated with high rates of delirium.      The aim of this pilot study is two fold. First, to determine the feasibility and potential     challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic     shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated     with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.   "
110756|NCT01836289|"     This research is being done to see if people with Crohn's disease who receive high-dose     cyclophosphamide have an improvement of their disease, how long the benefit may last, and how     safe cyclophosphamide is. This study is for patient with medically refractory disease that is     not easily amenable to surgery.      Cyclophosphamide is an FDA-approved chemotherapy medication that is also frequently used to     treat autoimmune illness; use of cyclophosphamide for autoimmune disease is not approved by     the FDA. An autoimmune illness is when the immune system mistakenly attacks self, targeting     the cells, tissues, and organs of a person's own body. There are many different autoimmune     diseases and they can each affect the body is different ways. Crohn's disease is an     autoimmune disease that primarily affects the small and large intestines. High     dose-cyclophosphamide has been successfully used to treat Crohn's, primarily as part of a     conditioning regimen for autologous stem cell transplantation. However, this therapy is     limited in Crohn's because of it's serious infectious risks. This current study involves     using high-dose cyclophosphamide without need for stem cell transplantation. This appears to     be a safer approach in other autoimmune illnesses that have been studied.   "
111148|NCT01831102|"     The purpose of this protocol is to measure and compare levels of the circulating protein     adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and     non-Latino white subjects. The investigators also aimed to examine associations between     nutritional factors and adiponectin levels.   "
118998|NCT01728337|"     this study was proposed to provide more scientific and objective data on the clinical and     aesthetic effects of these two toxins (Dysport and Xeomin).   "
110758|NCT01836263|"     Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the     skin and several internal organs.      Digital ulcers are frequent and have a major impact on the quality of life in patients with     systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the     principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and     inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy.     Consequently, there are at least three types of DU: (i) those localized at the tips of the     fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the     dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences     seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous     calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent     or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality     of life and spare the enormous costs due to conventional digital ulcer management.      This observational trial is part of the collaborative project DeSScipher, one out of five     observational trials to decipher the optimal management of systemic sclerosis.      Aim of this observational trial is:        1. To identify the best treatment combination for prevention of digital ulcers in patients          with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for          very early diagnosis of systemic sclerosis        2. To identify the best treatment associated with improved healing of digital ulcers in          patients with fulfilment of the new ACR/EULAR SSc criteria      Thus, the observational trial consist of a prevention arm and a healing arm.   "
110759|NCT01836237|"     Background: There are no published studies regarding the use of wound protectors in the     context of surgical site infection (SSI) rates among patients receiving a     pancreatoduodenectomy (Whipple) with preoperatively placed intrabiliary stents. In high     volume experiences, the SSI rate is 40-50% within this cohort. In Calgary, preoperative     biliary stent placement for bile duct decompression represents the norm given typical     surgical wait times. In addition to having higher associated lengths of hospital stay, ICU     admissions, hospital re-admissions, and overall mortality, patients with SSI are also     delayed, and often omitted, in their progression to critical oncologic adjuvant chemotherapy.     As a result, SSI remain crucial and devastating complications for pancreas surgeons and their     patients alike.      Methods: The investigators will complete a randomized controlled trial evaluating the rate of     SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent placement     when wound protectors are employed versus no wound protector use. This trial will employ     block randomization. All four University of Calgary Heapato-Pancreatico-Biliary (HPB)     surgeons will participate with a planned inclusion of all patients scheduled to undergo a     pancreatoduodenectomy.      Analysis: The investigators will use an intention to treat approach to the analysis.     Categorical baseline data will be analyzed using the Fisher exact probability test.     Non-categorical baseline data will be analyzed using the Student t test. SSI rates will be     determined using the Fisher exact probability test.      Hypothesis: Wound protectors will reduce the SSI rate in patients undergoing a     pancreatoduodenectomy with preoperatively placed intrabiliary stents.      Potential Impact: Given the tremendous oncologic, economic, and psychological impact of SSI     following pancreatoduodenectomy, the epidemic incidence of this complication must be reduced.     The additional crippling effect of refusing (Medicare) payment for any patient who receives a     SSI in the United States has launched all techniques and analyses that can potentially reduce     this complication into the National health care agenda. In Canada, health care utilization     and economics are always a relevant and ever expanding area of importance. It is crucial that     the investigators reduce complications such as SSI, regardless of individual payer sources.   "
110760|NCT01836224|"     The Patient evaluated in Emergency room since admission and detailed history and clinical     examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive     Care Unit (ICU) in view of septic shock were included since onset of shock.      Initial fluid resuscitation done and if the patient were no fluid responsive they were     randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the     primary objectives. At the same time the strict vitals monitoring and standard medical     therapy for sepsis including antibiotics and other supportive therapy continued. The patients     were followed up till discharge, death or up to 28days after enrollment into the protocol     (whichever the longest). The detail methodology has been explained in column 14 later.   "
110761|NCT01836211|"     -  The purpose of this study is to determine the efficacy and safety of an evaluation          strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed          by coronary computed tomography angiography (CCTA) in patients with low-intermediate          risk chest pain consistent with a possible acute coronary syndrome compared to a          standard of care (SOC) strategy.        -  Unicentric, randomized, controlled, open label clinical trial that will compare a fast          strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac          biomarkers followed by stress/rest imaging study).   "
110762|NCT01836198|"     The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and     clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes     to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part     A are divided into two cohorts (groups). Each cohort will participate in two study periods.     Period one involves a single dose of LY2409021. Period two involves either gemfibrozil or     ketoconazole for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and     will also involve screening within 27 days of the start of the study. Part B is only open to     participants who successfully completed Part A of the study. Participants in Part B will     receive one single dose of LY2409021 on Day 4 and clarithromycin for 21 days. Part B will     last for 29 days and will also involve screening within 27 days of the start of the study.   "
110763|NCT01836185|"     The purpose of this study is to measure how much of the drug gets into the bloodstream and     how long it takes the body to remove it when given to participants with hepatic (liver)     impairment compared to participants with normal hepatic function. Information about any side     effects that may occur will also be collected. This study will last approximately 28 days,     not including screening.   "
110764|NCT01836172|"     The purpose of this study is to evaluate the safety and efficacy of YJP-14 capsules for the     treatment of endothelial dysfunction in patients with diabetes mellitus.   "
110765|NCT01836159|"     A pilot randomized, two parallel group study comparing an iPad software game application     versus standard care in post-stroke patients.      Study hypothesis: Tablet PC technology using the iPad is a feasible and potentially     efficacious tool which has the potential to promote fine motor recovery of the upper     extremity after stroke.   "
110766|NCT01836146|"     The purpose of this First-in-Human Clinical investigation is to evaluate the safety and     performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the     treatment of patients with drug-resistant uncontrolled hypertension.   "
111149|NCT01831089|"     Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in     patients with solid tumors   "
147069|NCT01359228|"     The purpose of this study is to determine the effects of rifaximin on skin symptoms in     patients with rosacea by double-blinded, placebo-controlled, crossover study.   "
110769|NCT01836107|"     The purpose of this study is to make a Spanish version of a score that evaluates the     characteristics of a good quality clinical note for the purpose of physician communication.     The score is an instrument, originally made in English. Due to the score will be used in a     different country, language and culture of the original protocol, it is necessary apply a     process of translation and adaptation to the context where the score is going to be applied.      The process of validation implies to evaluate if the instrument produces the same results     under similar conditions and if the instrument maintains the ability to measure the same     features or characteristics according to the original design.   "
110770|NCT01836094|"     The purpose of the study is to evaluate whether low-dose USP methylene blue (MB) will: i)     improve short-term memory retention in a delayed match-to-sample task, ii) reduce reaction     time in a psychomotor vigilance test, and iii) enhance responses to a visual-motor task as     measured by functional magnetic resonance imaging (fMRI).      A single low-dose MB or placebo will be orally administered to self-declared healthy adults     using double-blind study design. Non-invasive fMRI data will be acquired before and after MB     administration in the same subjects. Each study will take 2-3 hours, inclusive of an hour     break in between.   "
110771|NCT01836081|"     The aim of this study is to investigate usefulness of the respirophasic variation in carotid     artery peak flow velocity measured by Doppler ultrasound, which is noninvasive and easily     accessible, as a predictor of fluid responsiveness in patients with coronary artery disease.   "
110772|NCT01836068|"     To find out if it is possible for HIV-1 patients to maintain antiretroviral medications     during allogeneic bone marrow transplant   "
110773|NCT01836055|"     -  The investigators are conducting a magnetic resonance imaging (MRI) study comparing two          MRI contrast agents in people with clinically isolated syndrome and relapsing remitting          multiple sclerosis (MS). MS is a disease that affects the white matter and gray matter          in the brain. MRI is used as a gold standard to visualize the degenerative changes in          the brain and spine. The neurologist will usually order an MRI to confirm the diagnosis          of MS using conventional imaging methods. These images reveal two main pieces of          information regarding (a) the location of the lesions and (b) the status of the lesions.          While the location of the lesions directly correlates with the clinical symptoms, the          information about the status of the lesions informs the neurologist whether the lesion          is new (active) or old (chronic).        -  This ability to differentiate new and old lesions requires the use of a contrast agent.          Currently, used agents reveal some lesions but it is unclear if they reveal the full          extent of the disease. In new lesions, there may be a leakiness in the blood vessels and          if the contrast agent leaks out then the investigators can see this. In healthy          controls, the blood brain barrier is usually intact and this leak does not happen. One          open question is: can the extravasation of the contrast agent to the brain precede the          major tissue damage that we see in the structural MRI?        -  Recently, a new FDA approved contrast agent (Gadavist) has been released and has          enhanced characteristics in terms of affecting the MR signal resulting in a better          contrast in the image and therefore, better diagnosis of the status of the disease.          Given its high relaxivity, a small amount of Gadavist may show a better signal          enhancement affected tissue for multiple sclerosis patients. The investigators          hypothesize that Gadavist will reveal more tissue damage (lesions) than Magnevist and,          therefore, may present a better tool for early diagnosis of brain damage.        -  The investigators' goal in this research project is to see if the newer contrast agent          is able to detect changes and differentiate healthy from affected tissue in the white          matter and gray matter earlier than current contrast agents so that detection can be          possible before major damage occurs to the tissue. Each person will be scanned initially          with one agent and then between 8 and 30 days later with the other agent. The MR data          processing results will be compared to check the efficacy of each contrast agent.   "
110774|NCT01836042|"     The purpose of this study is to assess the long-term safety of the Glaukos® iStent®     Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos     Study GC-003.   "
110775|NCT01836029|"     The purpose of this study is to compare the progression-free survival of patients with     recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with     VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin     or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival     will also be evaluated.   "
110776|NCT01836016|"     The aim of this study is to compare the effectiveness and economic evaluation of three     treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional     medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and     Chinese Treatment Guidelines; another, TCM treatments, which have been evaluated and have     certain effect; and finally, combination of both conventional medicine and TCM treatment,     then determine which treatment is the most suitable for COPD patients.   "
110777|NCT01836003|"     Access to highly active antiretroviral therapy can improve maternal health outcomes for the     4000 HIV- infected women who give birth daily and nearly eliminate transmission of HIV to     their infants. However, system inefficiencies, particularly CD4 testing to determine     treatment eligibility, are barriers. The project aims to study the effectiveness of a     programmatic intervention at improving antenatal access to treatment.   "
110778|NCT01835990|"     Trauma patients are at a high risk of developing blood clots in the legs (deep vein     thrombosis - DVT), which can travel to the lungs and cause serious health consequences.     Often, these patients cannot receive blood-thinning medication to prevent these blood clots     because of the risk of bleeding; in this case, they are usually given intermittent pneumatic     compression devices (IPCs) to prevent blood clots. IPCs are inflatable sleeves that fit over     the legs and periodically inflate and deflate, helping to pump blood out of the legs and thus     reduce the risk of blood clot formation. Several studies suggest that IPCs are working     properly on the patient only 60-70% of the time. Some patients also find them uncomfortable.     A new device (geko) that works by stimulating the leg muscles and increasing blood flow in     the legs has recently been developed. To compare the geko with IPCs, this study will randomly     assign trauma patients who cannot receive blood thinners for blood clot prevention to either     IPCs or geko. The main goal is to determine the feasibility of doing a larger study which     would compare the efficacy of these devices in preventing blood clots. The amount of time the     devices are properly used on the patients, comfort and tolerability, development of blood     clots, and blood flow in the leg veins and arteries will also be measured and compared     between the devices.   "
110799|NCT01835704|"     To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are     referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure     the health-related quality of life at the first visit and then during the following year.     Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this     and calculations of the cost we will be able to calculate the cost per QALY-gained which     makes it possible to compare interventional pain managment to other treatments for pain     patients.   "
110800|NCT01835691|"     This study is to research two questions. First, is vitamin D3 more effective than vitamin D2     in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients? And     secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral     metabolism parameters?   "
110779|NCT01835977|"     Multi-centre Randomized Clinical Trial: 200 patients with confirmed unilateral high-volume     low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4)     will undergo an IRE treatment. These patients will be randomized into one of the two groups     of the study.      Group 1: Focal ablation of the prostate at the side of the positive biopsies (focal-ablation)     Group 2: Extended ablation of the prostate (extended ablation)      Patients will have an ultrasound of the prostate and the imaging data will be entered into     the Planning Software system of the IRE-device. The volume of the prostate is measured and a     specified ablation zone will be determined. The patients will be admitted for overnight stay     in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed     under general anaesthetic and the specified zone identified in the planning stage will be     ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound     image guidance with a perineal approach using a brachytherapy grid. When the needles are in     place, electric pulses of one to two minutes duration are used to ablate the specified zone.     The total procedure time will be approximately 1 hour.      Safety data will be collected and patients will be followed up at 1 day post-operatively, 1     month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.   "
110780|NCT01835964|"     The purpose of this study is to investigate how blood sugar changes in response to insulin     and what the body does to counter-act low blood sugar in people with Type 1 Diabetes     Mellitus. Insulin sensitivity is the term used to describe blood sugar changes within the     body in response to insulin. Greater understanding of insulin sensitivity, particularly how     the body responds to low blood sugar, will help us to better predict how blood sugar levels     will change.      All subjects will receive a liquid mixed-meal and will have their blood sugar response     monitored in order to study insulin sensitivity. All subjects will receive additional insulin     injections that are given to cause a low blood sugar in order to understand how the body     responds to a low blood sugar. All subjects will be closely monitored during the time the     insulin is given, by frequent checks of blood sugar and constant medical and nursing     supervision. Details of the visits, tests and procedures are described below. During this     study, the study team will ask that subjects to use their own insulin pump and own     glucometer. Subjects will need to use the same glucometer for the entire study. Subjects will     be provided 1 box of strips. Subjects will be required to use lispro (Humalog) insulin 2-3     days before your inpatient admission which will be provided free of charge.   "
110781|NCT01835951|"     Simulation-based training is essential in learning or maintaining skills in high risk     industry such as aviation and railway and in the medical field like anaesthesia. Debriefing     following simulation is fundamental in order to reduce the emotional impact of the session     and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing     method is still to be found, individual debriefing is considered as the gold standard but     time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and     randomized study that will compare the individual (defined by learning couple resident and     nurse) approach to a grouped (several couples) debriefing. The primary end point is to define     the noninferiority of this approach compared to the individual one on the educational impact.      The learners will be debriefed according to their randomization after the first session, but     will all undergo individual debriefing following the second session.   "
110782|NCT01835938|"     Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and     hepatocellular carcinoma world-wide. Current combination therapy of pegylated     interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial     side effects.      The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV     infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM)     broadly inhibits HCV infection of all major genotypes including viral escape variants     resistant to host immune responses.      Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems     demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral     approach for prevention and treatment of HCV infection (European patent application EP 08 305     604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature     Medicine 2011).      Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a     well characterized safety profile in humans, the aim of the study is to investigate the     safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for     treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in     patients chronically infected with HCV. Following completion, this trial will set the stage     for a further investigation of entry inhibitors as antivirals in combination with standard of     care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical     trial will be an important step in the development of novel urgently needed antiviral     therapies overcoming resistance.   "
110783|NCT01835925|"     The purpose of this study is to study which genes are abnormal in rectal cancer and see if     this predicts how well chemotherapy and radiation will reduce the size of cancer and whether     cancer recurs after surgery.   "
110784|NCT01835912|"     Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via     liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies     have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active     muscles. This is due to an increase in activity of the pH sensitive monocarboxylate     transporter as the gradient of intracellular versus extracellular H+ increases. Therefore,     artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis     and increase the time to fatigue - defined as a decrease in force production with an     increased perception of effort. The investigators will test the null hypothesis that sodium     citrate ingestion (chronic and acute) will not have an effect on exercise performance     compared to placebo.   "
110785|NCT01835899|"     To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI     1015550 in healthy male volunteers   "
110786|NCT01835886|"     To determine if stair climbing can be used as a measure of progress in persons with pulmonary     disease.   "
110820|NCT01835431|"     This trial is conducted in Asia, Europe and North and South America. The aim of the trial is     to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus     insulin aspart for the remaining meals in children and adolescents with type 1 diabetes     mellitus.   "
110787|NCT01835873|"     Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia     obstetric deliveries because of the ability to use fewer drugs, a more direct experience of     childbirth and the capability to provide excellent postoperative analgesia. However, the     incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead     to maternal and fetal morbidities. Certain interventions may reduce the incidence and     severity of spinal anesthesia induced hypotension, including the use of vasopressors and     intravenous pre- or co-hydration using different types of volume expanders; crystalloid or     colloid solutions. Such interventions aim to increase maternal cardiac output, which is the     key in attenuating the hypotensive response to spinal anesthesia.      The primary purpose of this study is to compare the efficacy of intravenous prehydration     (preloading) of healthy parturients scheduled for caesarean section with either a crystalloid     (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of hypotension after     spinal anesthesia.      The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by     employment of a minimally invasive technique based on arterial pulse contour analysis.     Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a secondary     outcome. Other secondary outcomes are total amount of vasopressors used, neonatal outcome,     intraoperative side effects and maternal satisfaction scores.   "
110788|NCT01835860|"     To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative     treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold     standard surgical treatment- Transurethral Resection of Prostate (TURP).   "
110789|NCT01835847|"     Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium     (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action     (like the Tipepidine Hibenzate) is expected as a new curative medicine of adolescent     depression.      The purpose of this research is to confirm the effect by carrying out the additional dosage     of the Tipepidine Hibenzate to the adolescent patients with depression.      If suggestion is obtained by this research about the effect on adolescent patients with     depression of Tipepidine Hibenzate, it can contribute to development of the medical treatment     of adolescent patients with depression.   "
110790|NCT01835834|"     To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded     Zirconia on natural teeth in the posterior region for a period of 5 years. The working     hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges     of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded     Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings     (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference     level of 95%.   "
110791|NCT01835821|"     This clinical study has the objective to compare the longevity and the clinical behaviour     (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic     crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full     contour crowns IPS e.max CAD lithium disilicate on molars.   "
110792|NCT01835808|"     Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve     (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a     randomised trial - the FAME trial - where it was showed to be superior to classic anatomical     evaluation. Based on these results, current guidelines recommend the use of FFR (class I-A     recommendation) when objective evidence of vessel-related ischemia is not available. Since     the FAME trial was published, FFR use increased dramatically in most European countries,     Portugal being no exception to this trend. FFR is currently being used in many interventional     cardiology centres quite beyond the European Guidelines recommendation, since many physicians     now trust more on the information they can collect with pressure-wire during the angiography,     and less on non invasive imaging stress tests.      Considering this widespread use of FFR in the evaluation of patients with CAD, there is a     need to clarify the clinical results of this approach in a real patient setting. The     Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT) was     planned to evaluate if the use of FFR in the decision of coronary revascularization is     feasible and allows optimized clinical results in real world non selected patients, as     showed in clinical randomised trials.   "
110793|NCT01835795|"     The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in     myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and     imaging exams.   "
110794|NCT01835782|"     The purpose of this study is to determine the safety of L-Serine in subjects with Amyotrophic     Lateral Sclerosis (ALS) at varied doses.   "
110795|NCT01835756|"     The purpose of this study is to determine whether the Erchonia® ML Scanner (MLS) is effective     in the treatment of acute minor episodic chronic low back pain of musculoskeletal origin.   "
110796|NCT01835743|"     The purpose of this study is to determine whether the Erchonia HPS Laser is effective in the     treatment of chronic heel pain arising from plantar fasciitis.   "
110797|NCT01835730|"     This study is a first-in-human randomized, double-blind (Investigator and subject), placebo     controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo     per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).   "
110798|NCT01835717|"     Before Alzheimer's disease (AD) clinical symptoms appear, there is a long period when changes     in the brain occur. In this long asymptomatic period or preclinical phase, studies with     populations at risk of developing AD have shown cognitive differences compared to control     groups without such risk. There is a need for short, sensitive, easily administered,     reproducible, non-expensive and independent of socio-demographic influences tests enabling     the detection of pre-symptomatic variations in memory, when the memory decline is still     within a normal range.      Study main hypothesis: When evaluated with high-demanding tests of memory and executive     function, the cognitive performance of cognitive healthy people aged between 45 and 65 and,     extensively, to a group of up to 75 years, will vary significantly depending on clinical,     socio-demographic and genetic features   "
110821|NCT01835418|"     This study seeks to compare the differences in effectiveness among individual patients     treated at for hypertension with bedtime administration of amlodipine versus lisinopril.     There will be an analysis of whether one medication was more effective than another and     whether specific patient factors could predict who responded better to which one.   "
110801|NCT01835678|"     Diabetes mellitus is a metabolic disease with a growing prevalence worldwide, affecting 171     million people in 2000 and an expected 366 million people in 2030 (1) and therefore diabetic     nephropathy is rapidly increasing in the Western hemisphere and represents in up to 50 % the     cause of end stage renal disease. Hence, early intervention is desirable to prevent any     damage to the kidneys. In the early stage of diabetic nephropathy, endothelium dysfunction is     a key pathogenetic process as indicated by increased leakage of albumin through the     glomerular barrier (2).      Hence, improvement of endothelium function is an attractive therapeutic goal of antidiabetic     medication. Endothelial dysfunction, in particular basal nitric oxide activity, has been also     identified as pivotal determinant of glomerular filtration rate (3).      A new and promising class of antidiabetic drugs are the gliptins. Gliptins act by inhibiting     the enzyme dipeptidyl peptidase-4 (DPP-4), which is responsible for the rapid inactivation of     glucagon-like peptide-1 (GLP-1) - an incretin hormone of the gut (6 - 8), thereby enhancing     and prolonging the effects of GLP-1. GLP-1 - member of the incretin hormones - is released     into the blood after meal ingestion and stimulates the insulin secretion in a glucose     dependent manner. This accounts for the marked prandial insulin response, which prevents     prandial hyperglycemia.      Apart from surrogate parameters like reduction of fasting and postprandial blood glucose     levels or improvement of HbA1c, the effect of gliptins on micro- and macrovascular function     and cardiovascular outcome has not been the primary focus of current studies. However,     infusion of GLP-1, the incretin hormone affected by gliptins has been reported to ameliorate     endothelial dysfunction in patients suffering from coronary artery disease (9) and it was     recently shown that infusion of GLP-1 into healthy human subjects increases both normal and     ACh-induced vasodilatation (10). In studies on rats with diabetes, GLP-1 infusion nearly     re-established their normal vascular tone (11) and there are further data from experimental     animals that indicate a beneficial effect of GLP-1 on endothelial function (12).      It is of major interest whether therapy with gliptins improves endothelial function of the     micro- and macrovasculature. In face of the burden that diabetic nephropathy causes, the     effect of linagliptin on the renal vasculature and endothelium integrity of the renal     circulation (as measured by the availability of nitric oxide), is a key stone in order to     claim that linagliptin is an effective antidiabetic agents. There is a need to demonstrate     that linagliptin is effective beyond its blood glucose lowering actions and improves vascular     endothelium function in the kidney.   "
110802|NCT01835665|"     The purpose of this study is to determine the maximum tolerated dose of nimodipine as well as     the safety and tolerability of oral nimodipine in progranulin mutation carriers in     preparation for longer term efficacy studies in patients with frontotemporal dementia due to     progranulin gene mutations.   "
110803|NCT01835652|"     Parkinson's disease is caused by a reduction of dopamine causing motor deficits. The     investigators are studying how exercise can help PD patients by increasing dopamine release     in an area of the brain that coordinates movement, the striatum. The investigators will     enroll PD patients into two groups; one group will complete a 12-week aerobic exercise     program and the other will complete a 12-week control program including yoga and stretching     only. The investigators will measure changes in dopamine release before and after either     12-week intervention. Subjects will complete motor and cognitive questionnaires in addition     to functional magnetic resonance imaging and positron emission tomography neuroimaging.   "
110804|NCT01835639|"     This multi-site, pilot study will assess vitamin D supplementation in children and young     adults with Glomerular Disease. .   "
110805|NCT01835626|"     Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell carcinoma     at most institutions. The purpose of this study is to determine whether adding vismodegib to     radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study is to assess     the safety and tolerability of combined radiation therapy and vismodegib. This combination     may increase the chances of the tumors being destroyed or unable to spread to other parts of     the body in people with locally advanced basal cell carcinoma of the head and neck.   "
110806|NCT01835613|"     The purpose of this study is to assess the clinical response to IL-6 inhibition defined as     Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation     between the biomarkers and treatment response.   "
110807|NCT01835600|"     For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed     under general anesthesia with interrupted suspension of mechanical ventilation, which could     result in hypercapnia and hypoxia. In this study, the investigators hypothesize that 10 cmH2O     PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of     ventilation suspension but have no effect on carbon dioxide retention in blood.   "
110808|NCT01835587|"     The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486     (also known as oral Azacitidine) in patients with AML or MDS after allogeneic HSCT.     Allogeneic hematopoietic stem cell transplantation (HSCT) is more frequently used in Acute     Myloid leukemia (AML) or Myelodysplastic Syndromes (MDS) as a potential curative therapy.     However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal     causes of fatal complications after transplantation. Azacitidine has significant activity in     MDS and AML. Azacitidine has also demonstrated immunomodulatory activity in AML patients     after allogeneic HSCT. An oral formulation of Azacitidine provides a convenient route of     administration and an opportunity to deliver the drug over a prolonged schedule.   "
110809|NCT01835574|"     HIV risk among female entertainment and sex workers (FESW) remains high and use of     amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster     randomized stepped wedge trial: The Cambodia Integrated HIV and Drug Prevention     Implementation [CIPI) study. The CIPI study is embedded within the SMARTgirl HIV prevention     program. The CIPI study aimed to recruit FESW from 10 provinces, assessing HIV risk exposures     including ATS use. The CIPI study then tested sequentially delivered, behavioral     interventions targeting ATS use. The trial combines a 12-week Conditional Cash Transfer (CCT)     intervention with four-weeks of cognitive-behavioral group aftercare (AC) among FESW who use     ATS. The primary goal of the CIPI study is to reduce ATS use and unprotected sex among FESW.     The CCT+AC intervention is being implemented in ten provinces where order of delivery was     randomized. Outcome assessments (OEs) including biomarkers and self-reported measures of     recent sexual and ATS use behaviors are conducted prior to implementation, and at three     6-month intervals after completion. All women who are ATS negative at 6-months, including     those who have completed the CCT+AC intervention are eligible to participate in a     micro-enterprise (ME) opportunity. Consultation with multiple groups and stakeholders on     implementation factors facilitated acceptance and operationalization of the trial.     Statistical power and sample size calculations were based on expected changes in ATS use and     unprotected sex at the population level as well as within-subjects. Dissemination of process     indicators during the multi-year trial is carried out through annual in-country Stakeholder     Meetings. Provincial 'Close-Out' forums are held at the conclusion of data collection in each     province. When analysis is completed, dissemination meetings will be held in Cambodia with     stakeholders, including community-based discussions sessions, policy briefs, and results     published and presented in the HIV prevention scientific journals and conferences. CIPI is     the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia.     Results will inform both CCT+AC implementation in low and middle-income countries and     programs designed to reach FESW.   "
110822|NCT01835405|"     To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of     LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical     closure of surgical wounds.   "
111150|NCT01831076|"     This phase II trial studies how well exemestane before surgery works in treating     postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast     cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using     exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.   "
110810|NCT01835561|"     This study is for research purposes only and will not treat any disease or condition you may     have. The study is an open label and single dose study; open label means that you, the study     doctor and study staff will know which study drug you are taking.      The purpose of this research study is to compare drug levels in the body of people with liver     disease to drug levels in healthy people with a normal liver. In addition, the safety of the     study drug will be studied. Information about any side effects (discomfort or decline in     health) that may happen will be collected. The study drug will be given by mouth to subjects     with liver disease and to healthy subjects.      In the body, drugs are normally removed by the liver with a smaller amount being removed by     the kidneys. When the liver is not working as well as it should, the body may not be able to     remove drugs from the body quickly.      The information from this study will be used to decide if the drug is safe in subjects with     liver disease or if a lower dose of the study drug would be safer.   "
110811|NCT01835548|"     This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to     evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit     Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.   "
110812|NCT01835535|"     The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the     safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:        -  TIVUS™ Severe Resistant HTN Cohort        -  TIVUS™ Moderate Resistant HTN Cohort        -  TIVUS™ Failed RF Therapy Cohort   "
110813|NCT01835522|"     The goal of this study is to survey patients with a diagnosis of schizophrenia to determine     if there is a relationship between self-reported sexual function and treatment with     antipsychotic medication.      Hypotheses: 1. Patients on typical antipsychotics will rate their sexual function as lower     than those on atypical agents. 2. Patients on multiple antipsychotics will rate their sexual     function as lower than those on a single agent.   "
110814|NCT01835509|"     The primary aim of this randomized, controlled study is to evaluate the impact and     feasibility of a prolonged physical activity intervention in school-aged childhood cancer     survivors who self-report sedentary lifestyles. The study will test the hypothesis that     childhood cancer survivors participating in a physical activity intervention guided by Social     Cognitive Theory will increase the amount of time spent daily in moderate to vigorous     physical activity, and improve exercise self-efficacy compared to children randomized to     usual care. A secondary aim is to assess the impact of the intervention on cardiovascular     risk factors including fitness and body composition.   "
110815|NCT01835496|"     The objective of this study is to evaluate the pharmacokinetics of deferiprone and its     3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in     patients with sickle cell disease.   "
110816|NCT01835483|"     To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping     Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.   "
110817|NCT01835470|"     The purpose of this study is to assess the efficacy of Abatacept after intravenous     administration in Japanese children and adolescents with active juvenile idiopathic arthritis     who have a history of an inadequate response or intolerance to Methotrexate or biologics   "
110818|NCT01835457|"     Auto-immune diseases are characterized by an inappropriate inflammatory response against     tissues in the body and represent a major health care burden. Pro-inflammatory cytokines such     as TNF-α, IL-6 and IL-1β play a central role in the pathophysiology of many auto-immune     diseases. Innovative therapies aimed at limiting pro-inflammatory cytokine production in a     more physiological manner are warranted. In previous research conducted in an individual     known as the iceman, the investigators found that, through a autodidact     concentration/meditation technique, he appears to mount a controlled stress response,     characterized by activation of the sympathetic nervous system and enhanced production of     cortisol, both of which are known to result in immunosuppression. In accordance, while     practicing this concentration/meditation technique, the inflammatory response during human     endotoxemia (lipopolysaccharide [LPS] administration) was remarkably low in this individual.     Therefore, this technique could provide a novel means of controlling the inflammatory     response. However, the aforementioned results were obtained in just one subject, and hence     can not serve as scientific evidence for the effectiveness of the concentration/meditation     technique. The iceman claims that he can teach this technique to other subjects within a     relatively short time frame. Therefore, in the present study the investigators wish to     investigate the effect of concentration/meditation on autonomic nervous system activity and     the inflammatory response during experimental human endotoxemia in a controlled manner, by     comparing a group of subjects that are trained by the iceman and practice the     concentration/meditation technique with a group of subjects which do not.   "
110819|NCT01835444|"     Reallocation of healthcare is one solution to the problems healthcare is facing. In the     Netherlands reallocation of care to Physician Assistants (PAs) hasn't adequately been     studied. Given the growing number of PAs, it is essential to evaluate the effectiveness and     efficacy of (Dutch) PA services.      This multicenter matched-controlled study aims to evaluate the (cost) effectiveness of     substitution of hospital ward care from medical doctors (MDs) to PAs. The traditional model     in which the role of house officer is taken by medical doctors MD model) will be compared     with a mixed model in which a PA functions as house officer together with a medical doctor     (PA/MD model). Hospital wards will be matched on medical specialism and hospital type (i.e.     academic;non-academic). On the basis of USA studies, it is hypothesized that the mixed PA/MD     model compared to the MD model reduces the costs of healthcare, while improving or     maintaining the clinical outcomes, patients and provider satisfaction, and continuity and     quality of care.      Primary research question:      • What is the effect of 'mixed PA/MD model' compared with 'MD model' on efficiency of care?      Secondary research questions:        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on clinical and          patients outcomes?        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on continuity of          care?        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on nurses and          (specialist) medicals doctor experiences?        -  What are the barriers and facilitating factors considering the implementation of PAs as          house officer?   "
110852|NCT01834989|"     The purpose of the study is to test the hypothesis that stimulation of the synthesis of new     structural tendon proteins combined with training improve the tendon structure in patients     with chronic knee tendon pain.   "
110823|NCT01835392|"     The purpose of this study is to look at whether the use of a simple technique before surgery,     which involves inflating a blood pressure cuff on the infant's leg, can improve development     of language, motor and thinking skills at 12 months of age. Some research has found that a     brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm     may help the body to tolerate a longer and more severe shortage of blood (for example, during     surgery).   "
110824|NCT01835379|"     Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are     available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.     The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot     ulcers to heal than wounds treated with regular medical care. Subjects will have their     diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .   "
110825|NCT01835353|"     This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups     of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin     325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet     reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately     prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will     be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.   "
110826|NCT01835340|"     Propofol can be measured continuously in breath gas during anesthesia. This study compares     propofol concentration in plasma and breath gas and processed electroencephalographic     monitoring (bispectral index) under clinical conditions with patients and total intravenous     anesthesia. Target controlled infusion technique is used to deliver adequate propofol     concentration in plasma.   "
110827|NCT01835327|"     The current study proposes to address the question of whether patients' cerebral oxygen     saturation levels are predictive of their recovery from thoracic surgery. Further, the study     poses the hypothesis that a patient's poor recovery status goes on to increase a patient's     risk of developing post-operative morbidities such as pneumonia, arrhythmias and delirium.     The aim of this study is to address the observation that some patients struggle more than     others in their recovery and that 1) this may be a result of intraoperative cerebral oxygen     desaturations and 2) that this may affect their post-operative morbidity. If a potential     means of predicting poor outcomes is identified this will lead to further research into how     to adjust the associated variables, such as cerebral oxygenation, to improve patient     post-operative outcome.   "
110828|NCT01835314|"     Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a     research study, therefore children will only be monitored on a clinical basis for seizure     improvement predominantly by parent and caregiver report.   "
110829|NCT01835301|"     This study aims to test the hypothesis that plaque composition differs within a stent between     bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque     composition seen within a stent may be contributory to the late thrombotic events seen more     frequently with DES.   "
110830|NCT01835288|"     This phase II trial studies how well arsenic trioxide works in treating patients with     relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as arsenic     trioxide, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing.   "
110831|NCT01835275|"     The purpose of this study is to determine whether enhanced audio methods can be used to     improve analgesia for experimental pain in healthy subjects.   "
110832|NCT01835262|"     The primary objectives of the study are to evaluate the efficacy of subdissociative dose     intravenous ketamine compared with intravenous morphine in relieving acute pain in the ED.     Secondary objectives will include the rate of adverse effects and need for rescue analgesia.     The hypothesis is that intravenous administration of subdissociative dose ketamine at 0.3     mg/kg is superior to intravenous morphine at 0.1mg/kg in treating moderate and severe acute     pain in patients presenting to the ED.   "
110833|NCT01835249|"     Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause     of premature mortality worldwide. Early hypertension studies showed that treating elevated     blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality.     In subsequent research, patients achieved greater improvement in cardiovascular outcomes when     their treatment was aimed at a moderate systolic BP target (<150mmHg) than at higher targets.     Although observational data suggest that even lower BP targets may be beneficial, this has     not been seen in randomized trials; instead, intense treatment of hypertension (i.e., to a     target systolic BP <120mmHg) was found to have no effect on participants' risk for renal     disease, cardiovascular disease, or all-cause mortality.      One potential explanation for this apparent lack of benefit of intense BP targets is that the     study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory BP     monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP     measurements, nighttime systolic BP appears to be the best predictor of cardiovascular     disease and all-cause mortality. Because recent trials assessing intense BP targets did not     include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is     largely unknown.      To address this important gap in knowledge, we will conduct ABPM in 600 participants as part     of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT). The     goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based     BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of peak     BP, 24hr BP, and BP variability (secondary outcomes). The SPRINT trial includes approximately     9250 participants at high risk for cardiovascular disease.      The investigators hypothesize that intense targeting of clinic systolic BP does not lower     nighttime systolic BP compared to a standard target.   "
110834|NCT01835236|"     In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of     care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is     being combined with taxanes in the first-line setting. However, since therapy with     trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal     treatment strategy either in combination or in sequence with chemotherapy is still under     debate. This randomized phase II trial is studying a new strategy for the treatment of     metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and     pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy     with T-DM1 is then performed as second-line treatment. Third-line and further line therapies     are performed according to the physician's discretion. If this new therapeutic strategy is as     effective and better tolerated than the conventional strategy, this would mean a serious     breakthrough in the treatment of HER2-positive metastatic breast cancer.   "
110835|NCT01835223|"     This phase I/II trial studies the side effects and best dose of tivozanib and to see how well     it works in treating patients with liver cancer that has spread to other parts of the body or     cannot be removed by surgery. Tivozanib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
110836|NCT01835210|"     Acne vulgaris is a common problem in the adolescent community. Past research has shown that     acne affects teenager's self-esteem and mood. However, no research has evaluated the parent     perception of their teenager's acne in comparison to the severity of acne and the patient's     own reported quality of life. It is hypothesized that parents of teenagers underestimate how     much acne vulgaris affects their teenager's skin disease-related quality of life. Also that     teenager's perception of the severity of their acne is greater versus their parent's     perception. We believe that increased acne severity based on clinician assessment will     correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis     of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1     visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen     quality of life survey (modified for parents), and 2 Likert scales will be completed. In     addition, the clinician will score the teen's acne using the standardized Investigator Global     Assessment tool. Statistical analysis will compare teen subject answers to the Skindex-Teen     with their parent's answers. Also analyzed will be the severity of acne and differences     between the clinician IGA score and Skindex-Teen responses   "
110837|NCT01835197|"     This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a     Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability,     pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.   "
110838|NCT01835184|"     This phase I trial studies the side effects and best dose of cabozantinib-s-malate when given     together with vemurafenib in treating patients with solid tumors or melanoma that is     metastatic or that cannot be removed by surgery. Cabozantinib-s-malate and vemurafenib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
110840|NCT01835145|"     This randomized phase II trial studies how well cabozantinib-s-malate works compared with     temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma)     that has spread to other parts of the body and cannot be removed by surgery.     Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. It is not yet known whether     cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with     melanoma of the eye.   "
110841|NCT01835132|"     Background:      - Scleritis is the inflammation of the white outer coating of the eye, known as the sclera.     In severe cases, it can cause blindness. It is commonly associated with autoimmune disorders     such as rheumatoid arthritis. Mild scleritis can be treated with drugs such as ibuprofen.     More severe scleritis may need oral steroids or immunosuppressive treatments; however, these     treatments can cause side effects in the whole body. Gevokizumab is a newer anti-inflammatory     drug that is under investigation to treat other inflammatory diseases. It may not have as     severe side effects as some other drugs. However, it has not yet been used to treat     scleritis. Researchers want to see if it can be given as a safe and effective treatment for     scleritis.      Objectives:      - To see if gevokizumab is a safe and effective treatment for scleritis.      Eligibility:      - Individuals at least 18 years of age who have active scleritis.      Design:        -  There is an initial phase and a two-part extension phase in this study. The extension          phase is optional. The initial phase of the study requires seven visits to the National          Eye Institute (NEI).        -  Participants will be screened with a physical exam and eye exam, and medical history          will be obtained. Blood and urine samples will be collected.        -  Eligible participants will receive an injection of 60 mg of gevokizumab at the first          study visit and at Weeks 4, 8, and 12. They will be given under the skin by the stomach,          or in the upper arm or thigh.        -  Participants will have additional visits after the first study visit at Weeks 2, 16, and          28. No injection will be given at these visits. Eye exams will be done, and blood and          tear samples will be collected.        -  If the scleritis improves by Week 16, participants may choose to continue the study in          the extension phase. In the 1st extension, they will have a visit every 4 weeks until          Week 36 and then two additional monitoring visits at Weeks 40 and 52 for a total of 13          study visits.        -  Participants who are eligible at Week 52 may continue in the as needed (PRN) extension          phase (2nd extension) and receive gevokizumab injections (60 mg) at Weeks 52, 54, 58 and          62.   "
110842|NCT01835119|"     Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea,     vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the commonest     reasons for delayed recovery and discharge from hospital following abdominal surgery.     Advances in surgical techniques and peri-operative management such as the use of laparoscopic     surgery, thoracic epidural analgesia, early postoperative feeding and mobilization, amongst     others, have been shown to help in the resolution of postoperative ileus.      Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by     stimulating the cephalic phase of digestion and eliciting the release of multiple promotility     GI hormones. A number of small controlled studies evaluating the effect of chewing gum on     postoperative intestinal recovery in patients undergoing colorectal surgery have been     conducted. Decreased time for bowel function recovery and decreased hospital length of stay     have not been consistently documented, possibly owing to the insufficient power of existing     studies and study design issues. In addition, all previous studies have been limited by their     use of sugarfree gum, containing known motility agents (eg, sorbitol).      In this study, gum chewing was studied for its effect on women with surgical staging for     malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.   "
110843|NCT01835106|"     The investigators are investigating two ways of treating pain after hip surgery. One way is     though a thin tube (called a catheter), and it is placed into the back so that pain-numbing     drugs can reach the nerves near the backbone. This is called an epidural catheter. Another     way is to place the catheter close to the hip, where the surgery is done, so that the     pain-numbing drugs can reach some of the nerves more locally. This is called a fascia iliaca     compartment catheter.      The investigators do not know which way is best to treat pain, or has fewer side effects, or     allows a patient to leave hospital faster. Usually, patients would receive only one type of     catheter for pain relief. To do this comparison, the investigators would place both catheter     types, so that patients help us tell which one works better.   "
110853|NCT01834976|"     The purpose of this study is to investigate cardiac biomarker during perioperative management     in pediatric cardiac surgery.   "
119401|NCT01723046|"     The purpose of this pilot study is to investigate the clinical effects of a new upper limb     robot assisted therapy device that is linked to a virtual therapy environment in patients     with stroke.   "
110855|NCT01834950|"     The study is a single arm prospective study, aiming at identifying biomarkers of early     response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of     HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed     by breast conserving surgery. The investigators will study the association between the value     of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors     response (partial and complete response) using a logistic regression (main analysis).   "
110844|NCT01835093|"     Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium     (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action     (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit /     Hyperactivity Disorder (AD/HD).      The purpose of this research is to confirm the effect by carrying out the additional dosage     of the Tipepidine Hibenzate to the AD/HD patients.      If suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate,     it can contribute to development of the medical treatment of AD/HD.   "
110845|NCT01835080|"     The purpose of this study is to determine whether pulmonary arterial hypertension can worsen     or even cause sleep apnea. It is hypothesized that if pulmonary arterial hypertension does     indeed worsen or cause sleep apnea, then the treatment should first focus on the underlying     pulmonary arterial hypertension instead of the sleep apnea.      To determine if a person has sleep apnea, they will undergo one overnight polysomnogram     (sleep study). If it is found that they have mild to moderate sleep apnea, then the subject     will be invited to continue in the study and their pulmonary arterial hypertension will be     treated by their managing primary physician. After the subject has had treatment for their     pulmonary arterial hypertension, the study center will have them return for a follow up sleep     study to learn the effects of pulmonary arterial hypertension treatment management on their     sleep apnea, 12-24 weeks after the first sleep study.   "
110846|NCT01835067|"     This study will recruit patients who have recently had a submacular haemorrhage (bleed under     the part of the retina responsible for detailed vision), as a complication of wet age-related     macular degeneration (wet AMD). Wet AMD is a very common disease where abnormal blood vessels     form under the retina and leak, causing a significant reduction in vision.      The study will investigate treatment of the bleed with various combinations of the two drugs:     tissue plasminogen activator (tPA) - designed to dissolve the blood clot; and     perfluoropropane (C3F8) - designed to shift the blood clot away from the central part of the     retina (the macula). tPA is a commonly used 'clot-buster' drug for the treatment of stroke.     C3F8 is a gas commonly used in eye surgery. Patients recruited will be divided into four     groups: control group that receive none of the above drugs; one group that receives only tPA;     one group that receives only C3F8; and one group that receives both.      All patients will receive the current gold standard treatment for wet AMD, ranibizumab     (Lucentis®).      The aim of the study is to improve vision in a condition, which left untreated, would cause     severe visual loss.   "
110847|NCT01835054|"     Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America     and in Europe, and its prevalence is increasing with the aging of the population. Organic     Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR.     Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular     mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet     prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the     most frequent cause of severe MR leading to surgery in the western world. However, the best     current treatment for OMR remains uncertain and controversial. We have obtained preliminary     data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at     rest, as generally performed during routine clinical exam, does not necessarily reflect the     status of MR during patient's daily activities and thereby does not adequately assess the     risk of rapid progression and poor outcome in these patients. The objective of this study is     to identify the independent predictors of disease progression and outcome in patients with     asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers     to improve risk stratification and therapeutic decision-making process in patients with     chronic asymptomatic primary OMR.   "
110848|NCT01835041|"     This phase I trial studies the side effects and best dose of CPI-613 when given together with     combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs used     in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing.   "
110849|NCT01835028|"     Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical     LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both     situations are amongst the most challenging encountered in patients with valvular heart     disease. Although, CLF-LG AS is recognized has an important clinical entity, current     ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical management     of these patients . PLF-LG AS is a new entity recently described by our group, which is     characterized by more pronounced LV concentric remodeling with smaller LV cavity size and a     restrictive physiology leading to impaired LV filling, altered myocardial function, and a     low-flow state. Up to recently, this entity was often misdiagnosed, leading to     underestimation of AS severity and inappropriate delays for aortic valve replacement surgery     (SAVR). The two main challenges in patients with CLF- or PLF- LG AS are to distinguish     between a true-severe (TS) versus a pseudo-severe (PS) stenosis and to accurately quantify     the extent of myocardial impairment. Unfortunately, the traditional resting and stress     echocardiographic parameters currently used to assess the severity of valvular and myocardial     dysfunction in patients with LF-LG AS are far from being optimal, and as a consequence,     quantification of disease severity and therapeutic management may not be appropriate in a     substantial proportion of these patients.      THE GENERAL OBJECTIVES of the TOPAS study are to develop and validate new parameters and     biomarkers to improve the assessment of stenosis severity and myocardial impairment, the     risk-stratification, and the clinical decision making in patients with LF-LG AS and to assess     the impact of the different therapeutic strategies on patient outcomes.   "
110850|NCT01835015|"     The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics     of CLG561 in subjects with advanced age-related macular degeneration (AMD).   "
110851|NCT01835002|"     The purpose of this study is to determine the long term effects of transcorneal     electrostimulation (TES) in patients with retinitis pigmentosa (RP). In a prior study     (NCT00804102) the results of short term stimulation pointed to a positive effect on the     visual field and other parameters. In this study, the patients will be stimulated with the     OkuStim device for half a year and safety parameters will be measured.   "
147070|NCT01359215|"     The purpose of this study is to determine whether pediatric anesthesia is associated with     long-term hippocampal dysfunction   "
110856|NCT01834937|"     The purpose of this enhanced surveillance study (ESS) is to collect information regarding     chronic adverse events that are possibly related to the ExAblate® System (ExAblate) that     are received by InSightec (InSightec) following PMA approval. This study will examine     adverse events reported in patients undergoing the device procedure for the first two years     of commercial experience. Other relevant data may be collected as well.   "
110857|NCT01834924|"     Almost half of all US adults have trouble understanding and using health information, or low     health literacy. Health literacy is considered to be an important patient safety issue, and     has been linked to poor medication management. Low health literacy is a risk factor for     parent errors in administering medications to their children; difficulty understanding     provider medication instructions is likely to contribute to errors.      To address these issues, bilingual (English/Spanish), low literacy, picture-based medication     instruction sheets were developed. This study will look at the effectiveness and feasibility     of the medication instruction sheet-based intervention as it is used by providers in 2     pediatric emergency department settings, as part of a planned roll out of HELPix within the     hospital system. The investigators hypothesize that there will be reduced medication dosing     errors, improved medication adherence, reduced hospital revisit rates, and improved     provider-parent communication. The investigators also hypothesize that provider technology     experience, knowledge, and attitudes, will affect the extent to which providers use the tool.   "
110858|NCT01834911|"     Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve     postural stability in Huntington disease (HD) patients as measured by computerized dynamic     posturography testing. This study aims to elucidate whether partial dopaminergic depletion     via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on     the Stroop interference test.   "
110859|NCT01834898|"     The hypothesis of this study is that controlled release oxycodone can be safe and well     tolerated for the control of postoperative pain in surgery for head and neck cancer. The     primary objective is to study the safety and the incidence and severity of adverse effects,     and the secondary objective is to evaluate the analgesic efficacy and identify the frequency     of use of rescue medication and the prescribing physician's opinion about the quality of     postoperative analgesia with oxycodone controlled release in oncologic surgery of the head     and neck.   "
110860|NCT01834885|"     Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in     patients with moderate to severe airflow limitation   "
110861|NCT01834872|"     The aim of this prospective observational study is to evaluate the performance of Amigo RCS     in ablation procedures for most common arrhythmias as compared to a conventional manual     approach.   "
110862|NCT01834859|"     Very-low calorie diets are relatively safe and effective in inducing significant weight loss,     when used in selective individuals and under clinical supervision. However, weight loss     maintenance in the long-term remains the main challenge, with many experiencing a significant     weight regain. Several compensatory mechanisms are activated under weight reduction, both at     the level of energy intake (such as increased appetite) and energy expenditure (such as     reduced energy expenditure), and increase the risk of relapse.      The main aim of this study is to compare the effect of two multidisciplinary lifestyle     interventions on weight loss maintenance at one year, after initial weight loss during 8     weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an     outpatient program in the obesity unit of the local hospital, or to an inpatient program     consisting of a continuous care intervention, with three intermittent stays (each with     three-week duration) in a rehabilitation center over a one year period. Moreover, the     investigators aim to assess the impact of weight loss (achieved with a very low calorie diet)     and weight loss maintenance on compensatory mechanisms activated during weight reduction.   "
110863|NCT01834846|"     The success of coronary artery bypass grafting is reliant on the quality of the grafts used.     A new technique for harvesting veins used as grafts has been introduced. The study hypothesis     is that veins harvested with this technique have an improved endothelial function.   "
110864|NCT01834833|"     Evaluate the benefit of systematic appointment with a cardiologist a week after     hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of     hospital during 6 months   "
110865|NCT01834820|"     In infancy, bronchiolitis is the most common acute infection of the lower respiratory Tract.     The current treatment of bronchiolitis is controversial. Bronchodilators and corticosteroids     are widely used but not routinely recommended. Hypertonic saline is currently the only drug     recommended by the Spanish Association of Pediatrics in treatment guidelines.      The purpose of this study is quantify whether epinephrine, dexamethasone, and hypertonic     saline are effective to decrease the rate of hospital admissions at seven day, also verify     adverse effects in patients submitted.   "
110866|NCT01834807|"     This retrospective, observational, multi-center study will evaluate the use of biological     agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid     arthritis. Data from medical record files will be collected of patients currently treated     with a biologic in monotherapy.   "
110867|NCT01834794|"     This project aims to develop and test an intervention for the simultaneous treatment of     cannabis use disorders and tobacco smoking. This is important because over 50% of adults     seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases     their chance for a successful treatment outcome and increases adverse acute and long-term     psychosocial and health consequences. The proposed treatment will integrate existing     computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement     medications to improve outcomes in this difficult to treat clinical population.   "
114193|NCT01791166|"     Open multicentric prospective study performed on pulmonary transplanted patients to detect     the values of different diagnostic markers for immuno- humoral reaction and their roles in     the humoral rejection for those patients.   "
110880|NCT01834625|"     In this pilot study the investigators shall prospectively in a blinded fashion evaluate with     Aβ PET and CSF Aβ42 and tTau or pTau in patients committed to shunt surgery and then     investigate the relationship of these biomarkers with outcome on gait, cognition and urinary     control improvement in the short term (3 months) and long term (1 year). The imaging agent     will be provided by AVID.      Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide     information on amyloid burden.   "
110869|NCT01834768|"     Kidney transplant recipients usually lose their graft by rejection or by immunosuppressive     drugs toxicity. In kidney transplantation, calcineurin-inhibitors (including cyclosporine A)     are widely used. Their renal toxicity could be divided between an acute toxicity (toxic     arteriolopathy and toxic tubulopathy) and a chronic toxicity (hyaline arteriolopathy,     interstitial fibrosis, tubular atrophy and glomerulosclerosis). Several animal models have     shown the implication of the mineralocorticoid receptor (MR) activation in those toxic     phenomenons. The use of a mineralocorticoid receptor antagonist is useful regarding to the     renal function and kidney histological damages.      Several antagonists are available in France but none is indicated in kidney transplantation.     Eplerenone appears to be the most selective molecule of the mineralocorticoid receptor and to     have less adverse anti-androgenic effects than others molecules. Its principal adverse events     are hyperkalemia and orthostatic hypotension. Mineralocorticoid receptor antagonists,     especially eplerenone, could be very useful in the prevention of the nephrotoxicity induced     by calcineurin-inhibitors.      Classically, eplerenone is contra-indicated in patients presenting with an impaired renal     function, determined by a creatinine clearance under 50mL/min. Moreover, in France, a warning     is especially notified for the association with cyclosporine A due to the fact that no study     have been done in this context.      The investigators study first the safety of the use of eplerenone in association with     cyclosporine A in kidney transplant recipients. Then, if it is safe, the investigators will     study its efficiency in a large randomized controlled trial.   "
110870|NCT01834755|"     Highlighting the relationship between psychological and physical profiles and patient's     preference to better understand the patient's treatment preference and improve the     information provided.   "
110871|NCT01834742|"     This study is to investigate the effect of various modified low volume polyethylene glycol     (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool     output in healthy subjects. In addition, the study is to assess and compare the safety and     tolerance of the modified PEG+ASC formulations following oral administration with the safety     profile of MOVIPREP®.   "
110872|NCT01834729|"     This study is designed to better understand the effects of effects of stress, relaxation, and     a medication alfuzosin on bowel control and emptying in healthy people and patients with     bowel problems.   "
110873|NCT01834716|"     5.4 million Americans have Alzheimer's disease (AD) costing $185 billion annually, while 15     million caregivers look after these individuals. AD is the sixth leading cause of death, but     the only one in the top 10 causes that cannot be prevented.      This study may demonstrate exercise in an amount attainable by many will be preventative in     asymptomatic individuals including those with brain Abeta deposition already that are at     impending risk of the disease. Sperling and colleagues(1) coined the research term     AD-pathophysiological process (abbreviated AD-P) for use in studies such as the intervention     in this proposal.      Our long term goal is to assess whether exercise may be preventative of AD at older ages     (=73, mean=75), when more than 40% of cognitively normal persons have A beta deposits, the     hallmark of AD pathogenesis, in their brains. In a NIH RO1 grant submission the investigators     proposed to conduct a partially blinded controlled preventative trial in 150 cognitively     normal individuals, randomized in a 2:1 ratio to 18 months of moderate aerobic exercise     versus 18 months of toning and stretching. All persons would have baseline and 18 month brain     Abeta PET studies. The study was designed to determine whether an exercise intervention in     persons mean age 75 would lead to decreased brain Abeta accumulation, increased hippocampal     volume, improved cognition, and improved dementia-related biomarkers compared to the control     group. The study would be unique in that the investigators would be able to examine if     aerobic exercise slows the accumulation of brain Abeta in an older population, at which time     Abeta deposition is common. If successful, this would provide an additional motivating reason     to recommend exercise for most elderly persons.   "
110874|NCT01834703|"     This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine Artery     Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients with     uterine fibroid.   "
110875|NCT01834690|"     Conventionally, the outcome of liver transplantation is usually reported in terms of graft     and patient survival, medical and surgical complications, but lack of health-related quality     of life (HRQOL) that might be associated with immunosuppression complications (e.g.,     diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease,     renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections     after transplantation.   "
110876|NCT01834677|"     The purpose of this study is to evaluate the psychometric properties and utility of new,     computerized, neurocognitive measures in humans with depression, and humans with depression     undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as     there is the possibility of developing better computerized neurocognitive measures, and the     risks are limited to no more than minimal test related fatigue and psychological stress.      Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with     Parkinson's disease (age 18-85) will be invited to participate in this study. After providing     informed consent participants will undergo a clinical psychiatric evaluation to confirm the     inclusion/exclusion criteria. After the clinical psychiatric evaluation, participants will     complete common and new neurocognitive measures. There will be a total of two testing visits     (baseline, 1-month follow-up). The anticipated duration of the participant's involvement is     no more than 2 study visits that can take place over a 4-day period (i.e., the clinical     evaluation can occur on day 1 and the neuropsychological measures can be administered on day     2 of each study visit) equating to approximately 6-hours (3-hours each day) per study visit.   "
110877|NCT01834664|"     This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow     derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36     months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy     in India. Primary outcome measures are improvement in walking ability and kinetic gait     pattern.   "
110878|NCT01834651|"     This research study is being done to measure the clinical benefit associated with     cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs     (organs other than bone or lymph nodes) and no longer responds to initial hormonal     (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant     prostate cancer.   "
110884|NCT01834573|"     Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life     compared to healthy adults. This is due to the chronic course of disease accompanied with     diarrhea, stomach pains but also with psychological stress.      It is known that physical education may improve course of disease and quality of life in a     multitude of diseases. These include coronary heart disease, malignancies and also     depression. The investigators believe that sport is as effective supportive tool in improving     quality of life in IBD patients. But data is lacking with regard to controlled randomized     clinical trials. Because of the small amount of data available the investigators considered a     feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The     investigators further suspect that these patients improve their quality of life compared with     patients in the control group.   "
110885|NCT01834560|"     Despite the availability of several treatments, a number of patients with major depression     are refractory to therapeutical approaches and therefore suffer from chronic handicap. For     these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting     bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the     patients.      This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In     this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS)     of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an     alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s     with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since     1992, psychosurgical therapies that respect ethical recommendations have regained interest to     treat highly impaired patients. Before the investigators can propose deep brain stimulation     of subgenual cingulate brain region as a new therapeutic approach for the investigators     patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a     group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to     the model used by Drs. Lozano and Mayberg and the investigators took advantage of the     investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.      Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their     preliminary results. Cartography of physiological consequences of this procedure will be     assessed by measuring cerebral blood flow by PET scan (positron emission tomography).     Patients will be monitored and thoroughly assessed during including psychiatric,     neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment     efficacy and potential adverse reactions. Patients will be followed for two more years to     assess medium-term complications. This study will be a first step toward further research     including potentially a multicentric clinical trial.   "
110886|NCT01834547|"     Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of chess     players in chess games and neuropsychiatric standardized tests. We hypothesize that     substances will change cognitive performance in chess players leading to changed results in     chess games and neuropsychiatric tests.   "
110887|NCT01834534|"     The objective of this research is to test the efficacy of CarePartners for Depression     (CP-D) intervention, which was designed to increase between visit monitoring of depression     status and enhance self-management.      **In order to participate, subjects must be patients at participating clinics: Alcona Health     Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.   "
110888|NCT01834521|"     The ever expanding breast cancer survivor population urges the health care system to develop     (cost-)effective screening and management of convalescent care needs that can be easily     implemented in conventional follow-up care. Internet-delivered systems may be well-equipped     to meet these demands. The aim of the current study is to assess the effectiveness of a     web-based support system. Key features of this system are patient self-screening of physical     and psychosocial problems, tailored patient education on reported problems and self-referral     to professional care. In this era of high internet usage, we expect that internet is a highly     suitable medium to provide tailored support for breast cancer patients and will empower the     patient to take control over their convalescence.   "
110889|NCT01834508|"     The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5     mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.   "
110890|NCT01834495|"     The purpose of the investigators study is to examine and compare primary patency between     balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus     COMPLETE-SE) in atherosclerotic iliac artery lesion.   "
110891|NCT01834482|"     The modified Atkins diet (MAD) has been shown to be effective in treating children and adults     with medically resistant seizures. A recent study in children showed that the use of KetoCal®     once per day in addition to the MAD appeared to be beneficial when used during the first     month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one     meal during the initial month of the MAD will produce urinary ketosis in more adult patients     than the MAD alone and will lead to greater seizure reduction.   "
110892|NCT01834469|"     The purpose of this study is to determine if NIF fluorescent imaging is an effective approach     to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer     patients.   "
110935|NCT01833910|"     Prompt delivery of cardiopulmonary resuscitation (CPR) can double a victims chance of     survival from cardiac arrest (CA), yet it is provided in less than 1/3 of witnessed events.     Studies indicate that video-based education methods can effectively train bystanders in CPR.     Using the education and evaluation methods of an existing in-hospital training program, the     investigators will assess the CPR skills of students taught with video-only methods, with and     without psychomotor skills practice, and compare them to those using a video self-instruction     (VSI) kit.   "
115006|NCT01780519|"     The investigators' goal is to determine if certain tests of memory and attention, performed     while sleepiness is induced by a single dose of lorazepam, can predict whether or not an     individual is at risk for developing Alzheimer's disease.   "
110893|NCT01834456|"     Under the auspice of 'Specially for Children and with funding from the Seton Healthcare     Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and     integrated model of care for children with medical complexity. This model serves as the     patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who     work as hospitalists and within the PCP) and nurse practitioners to provide continuous care     between hospital and primary care. This model seeks to provide a system of care that more     fully meets the complex needs of the child and family, while implementing innovations in care     delivery, fully implementing family-centered practice, and embedding behavioral,     psychiatric, psychosocial, and palliative care. This study is a randomized intervention trial     that evaluates the effectiveness of the newly-created Children's Comprehensive Care on two     outcomes: utilization and cost of care; and, evaluation of the experience of parents and     their families.   "
110894|NCT01834443|"     The purpose of this study is to determine whether galvanic vestibular stimulation is     effective in the treatment of spatial neglect after right brain-damage.   "
110899|NCT01834378|"     We randomize individuals with impaired glucose tolerance to one of three arms for degree of     physical activity: 1. Continue with your current life style; 2. Ordinary life activities for     increased physical activity; 3. Scheduled group activities for changed behavior. The overall     aim is to focus on change of physical activity and to keep other life style activities more     or less unchanged (diet, smoking, etc) and the effect on metabolic variables.   "
110900|NCT01834365|"     There is a structured educational effect on blood pressure reduction in elderly hypertensive     patients.   "
110901|NCT01834352|"     The purpose of this study is to determine if walnut oral immunotherapy can be used in     subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their     immune system.   "
110902|NCT01834339|"     The purpose of this study is to compare the safety and effectiveness of performing oral     reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or     AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a     type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.   "
110903|NCT01834326|"     The purpose of this study is to improve the current standard of care of repairing mouth soft     tissue defects.   "
110904|NCT01834313|"     The purpose of this study is to evaluate the monetary value of patient-centrednes in health     care by determining a willingness-to-pay for more patient-centredness care for both patients     and health insurers   "
110905|NCT01834300|"     This project examines the effects of a 4 month structured exercise intervention program in     patients with non-alcoholic fatty liver disease (NAFLD). We will examine changes in total and     depot-specific (i.e.in different tissues, liver, muscle and pancreas)fat. We will correlate     these with measurements of the insulin from the liver. The hypothesis is that by reducing fat     in these specific depots we can reduce insulin resistance and prevent progression to     diabetes.   "
110906|NCT01834287|"     In this study, investigators are specifically targeting Latina women as they are more likely     to be inactive and, therefore, are at higher risk for developing chronic conditions such as     obesity, diabetes, or cardiovascular disease.      The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical     Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact     Control condition. Participants are randomly assigned to one of two groups (Exercise and     General Wellness).      The investigators hypothesize that at the end of treatment, intervention participants will     report significantly more minutes of moderate intensity physical activity per week than the     wellness contact control participants.   "
110907|NCT01834274|"     The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin     compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.   "
110908|NCT01834261|"     Oxytocin is a neuropeptide that is well known for its role in social and affiliative behavior     in humans. Oxytocin receptors are significantly lowered in autistic individuals and     administration of oxytocin has shown benefits in enhancing social recognition and behavior in     autistic children. However, more recent research has refined the behavioral effects of     oxytocin, moving away from the notion that the neuropeptide blindly induces love and trust,     towards the view that it actually increases social perception in assessing friend vs. foe:     supporting cohesion with 'insiders' and distrust and aggression for 'outsiders.' Oxytocin is     responsible for the selective aggression shown by lactating female mammals protecting their     young, an effect demonstrated also in humans, and has been shown to strengthen feelings of     ethnocentrism. However, no neuroimaging study to date has investigated this effect, with the     consequence that its neurobiological basis is still unknown.      The general aim of our study is to determine meso-circuit brain dynamics that underlie     oxytocin's amplification of both trust and aggression; and specifically, using neuroimaging     (fMRI, magnetoencephalography, and behavioral testing) whether oxytocin amplifies kinship     bias by attenuating social reward learning.   "
110936|NCT01833897|"     The purpose of this study is to test whether ketamine and D-cycloserine can be safely and     effectively used for the treatment of depression. The investigators hypothesize that ketamine     will serve as a rapid acting and safe antidepressant in patients with bipolar depression, and     furthermore, that D-cycloserine will serve as an effective therapy following ketamine     treatment.   "
110909|NCT01834248|"     This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion     protein CDX-1401 and decitabine in patients with myelodysplastic syndrome or acute myeloid     leukemia. DEC-205-NY-ESO-1 fusion protein, called CDX-1401, is a full length NY-ESO-1 protein     sequence fused to a monoclonal antibody against DEC-205, a surface marker present on many     immune stimulatory cells. This drug is given with another substance called PolyICLC, which     acts to provoke any immune stimulatory cells which encounter the NY-ESO-1-DEC-205 fusion     protein to produce an immune response signal against NY-ESO-1. Immune cells which have thus     been primed to react against NY-ESO-1 may then attack myelodysplastic or leukemic cells which     express NY-ESO-1 after exposure to the drug decitabine. The chemotherapy drug decitabine is     thought to act in several different ways, first, it may directly kill cancer cells, and     secondly, the drug can cause cancer cells to re-express genes that are turned off by the     cancer, including the gene for NY-ESO-1. Giving DEC-205/NY-ESO-1 fusion protein (CDX-1401)     and polyICLC together with decitabine may allow the immune system to more effectively     recognize cancer cells and kill them.   "
110910|NCT01834235|"     This is a randomized phase II multi-institution prospective open label study in which up to     90 subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who     previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen     will be enrolled into one of two arms:      A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel   "
110911|NCT01834222|"     The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean     adults in the routine clinical setting, as required for any new drug approved by Korea Food     and Drug Administration (KFDA).   "
110912|NCT01834209|"     The purpose of this study is to collect additional safety data during treatment with     abiraterone acetate plus prednisone or prednisolone among adult participants with     asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC)     who reside in areas in which abiraterone acetate is not yet available for this indication     through local healthcare providers, and who are not eligible for enrollment into an available     ongoing clinical study of abiraterone acetate.   "
110914|NCT01834183|"     This research study is a PHase II clinical trial, which tests the safety and effectiveness of     an investigational combination of drugs to learn whether the combination of drugs works in     treating a specific cancer. Investigational means that the combination of drugs is being     studied. It also means that the FDA has not yet approved these drugs or combination of drugs     for use in participants, including people with your type of cancer.      Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood     supply so that it does not get the blood and nutrients it needs to grow. This drug has been     used in other research studies and information from those other research studies suggests     that this drug may help to slow the growth of cancer cells.      Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of     pancreatic cancer and several other cancers. It is not approved for the treatment of renal     cell carcinoma. Previous research suggests combining gemcitabine with tivozanib may have some     effectiveness in treating metastatic renal cell carcinoma.      The purpose of this research study is to determine the effectiveness of tivozanib as a     treatment for renal cell carcinoma. The purpose of this research study is to also determine     if the combination of tivozanib and gemcitabine is effective in treating your type of cancer     if your cancer becomes unresponsive or gets worse with tivozanib as treatment alone. The     safety of the combination of tivozanib and gemcitabine will also wbe studied.      Another goal of this research study is to learn more about how tivozanib alone and the     combination of tivozanib and gemcitabine may work to treat renal cell carcinoma. During the     research study we will perform blood tests to measure the level of substances in the blood     such as proteins (biomarkers) that may predict who will respond to treatment with tivozanib     and gemcitabine.   "
110915|NCT01834170|"     Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause     of cancer death. The only effective treatment for pancreatic cancer includes surgery.     However, only 20% of the patients have surgically treatable disease. Also, the 5-year     survival for the surgically treated patients is only 15%.      About 40% of the patients present with advanced disease with distant metastasis, and the     remaining 40% present with locally advanced unresectable cancer with the tumor invaded into     surrounding major vessels. For those with locally advanced disease, systemic chemotherapy     with or without radiotherapy provides palliation of the symptoms but cannot cure the     disorder. Systemic chemotherapy is given through peripheral vessels.      The investigators hypothesized that direct injection of the chemotherapeutic drug into the     tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with     locally advanced pancreatic cancer.   "
110916|NCT01834157|"     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of     the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis,     calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to     impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in     other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate     mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand     function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease     activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related     arthritis, too.      This observational trial is part of the collaborative project DeSScipher, one out of five     observational trials to decipher the optimal management of systemic sclerosis. Aim of this     observational trial is to:        -  investigate the efficacy and safety of different treatments on hand dysfunction in          systemic sclerosis patients with hand arthritis and        -  to validate the CDAI for arthritis in systemic sclerosis.   "
110946|NCT01833767|"     The purpose of this study is to determine response rates by administering low dose     cyclophosphamide on day 1, followed by 5 days of outpatient IL2.   "
110947|NCT01833754|"     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile     of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients     with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.   "
110948|NCT01833741|"     This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated     intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension     (OHT) in a clinical setting.   "
111028|NCT01832701|"     Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic     acids) and bioavailability of these bioactive compounds is now somewhat well understood. In     addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence     remains to be observed in vivo. The objective of this trial is to understand if regular (14d)     coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and     plasma after an acute stress caused by exercise.   "
110917|NCT01834144|"     Background/Justification: Regular physical activity (PA) has substantial health benefits in     persons with type 1 diabetes (T1D), including reduced risk of complications and     cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly     less active than their peers without diabetes. Two major factors likely explain the low rates     of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly     nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for     achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated     that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking)     PA sessions may overcome these limitations. No studies have tested the efficacy of high     intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability     in a randomized controlled trial (RCT).      Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the     hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate     intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period     following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate     intensity PA intervention will elicit significant improvements in glycemic excursions, as     measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period     following exercise.We are also exploring the hypothesis that reducing the risk of     hypoglycemia will lead to a sustained increase in physical activity one year after     randomization.   "
110918|NCT01834131|"     The objective of this cluster randomized trial is to test whether a comprehensive     intervention program within a national public primary care system will improve hypertension     control among uninsured hypertensive patients and their families in Argentina.   "
110919|NCT01834118|"     The purpose of this study is to determine the effect of repeated renal denervation in     non-responding patients with severe hypertension. Therefore ultrasound technique will be     used.   "
110974|NCT01833403|"     This is a pilot study to show that it is possible to identify the specific types of fats in     blood, adipose tissue, and liver tissue. The study doctors hope to use the analysis of these     fats to learn more about nonalcoholic fatty liver disease (NFLD). Nonalcoholic fatty liver     disease is the accumulation of fat in the liver of people who have minimal alcohol exposure.     Nonalcoholic Fatty Liver Disease is associated with obesity and insulin resistance, and     predicts development of Type 2 Diabetes. The study doctors are interested in looking at the     relationship between liver fat and insulin resistance.   "
110920|NCT01834105|"     This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and     protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between     CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe the     mRNA and protein 's expression of CBP、JAK1、STAT4 and the protein phosphorylation of     JAK1、STAT4 in JAK-STAT signal to reveal the CLCF1 regulate the CBP's mechanism.Use the Liuwei     Dihuang Pills to detect the effect of treatment ,compare use or not the Liuwei Dihuang Pills     to detect the mRNA and protein 's expression of CLCF1、CBP etc.Aim to clarify the POP kidney     Yin deficiency molecular mechanism.   "
110921|NCT01834092|"     The investigators want to measure the degradation of the endothelial glycocalyx before and     after clamping the aorta, in patients operated for a abdominal aortic aneurism.   "
110922|NCT01834079|"     This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow     derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted     for 36 months in patients with optic nerve diseases.   "
110923|NCT01834066|"     This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow     derived autologous cell(100 million per dose) for the patient with Duchenne Muscular     Dystrophy.   "
110924|NCT01834053|"     This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow     Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36     months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in     cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable     Movements called Chorea.   "
110925|NCT01834040|"     This Study is single arm, single center trial to check the safety and efficacy of BMMNC (100     million per dose) for the patient with Duchenne Muscular Dystrophy,   "
110926|NCT01834027|"     The purpose of this study is to investigate the effects of music on patients after surgery in     the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant     emotional stress and anxiety which can include discomfort or pain. Music therapy has proven     to be a useful adjuvant in various inpatient and outpatient settings by providing a relaxing     effect that decreases heart rate, blood pressure, and hormonal measures of stress. It has     been shown that classical music can cause physiological and psychological differences in     patient outcomes, but few studies have looked specifically at effects of jazz music. Some     have argued that jazz may be too involved to provide the same relaxed state as classical     music, but this may be due in part to the type of jazz played for the patient. It is our     hypothesis that slow jazz music by artists including Miles Davis, Ella Fitzgerald, Diana     Krall, Dave Brubeck, etc. will reduce measures of stress and anxiety in patients in the PACU     following surgery for hysterectomy (laparoscopic or robotic) to a greater extent than the     control group. Jazz music or no music will be played through headphones to participants in     the study post-surgically while they are in the PACU and measures of stress, anxiety, and     pain will be monitored.   "
110927|NCT01834014|"     The correlation between the values of angiogenesis-related growth factors in plasma and     efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity     or resistance to treatment will be examined exploratively.   "
110928|NCT01834001|"     Background:      - Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes     them to die. Radiation can be effective, but some tumors may be harder to treat with     radiation or even with surgery. This happens to a small number of men who have either     radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not     know if the tumor has recurred only in the prostate or has spread to another area. Also, men     whose prostate cancer has recurred only after radiation may have different treatment options.     This study will use improved imaging studies to better understand why some men do not respond     as well to initial radiation treatments.      Objectives:      - To use detailed imaging studies to look at the results of local radiation therapy for     prostate cancer.      Eligibility:        -  Men at least 18 years of age who are scheduled to have radiation for prostate cancer.        -  Men at least 18 years of age whose prostate cancer has returned after earlier          treatments.      Design:        -  All participants will have a medical history and physical exam. Blood and urine samples          will be collected. Imaging studies will be used to evaluate the cancer at the start of          the study.        -  All participants will have an initial full magnetic resonance imaging (MRI) scan of the          prostate. Tumor and healthy tissue samples will be collected.        -  Those whose cancer has recurred after treatment will discuss possible treatment options          with the study doctors.        -  Participants who are scheduled to have radiation will have radiation therapy. This will          be given according to the current standard of treatment.        -  After radiation, participants will have regular follow-up tests and imaging studies.          They will have another full MRI scan 6 months after the end of radiation treatment.   "
110929|NCT01833988|"     This study will test the hypothesis that a wearable automated bionic pancreas system that     automatically delivers both insulin and glucagon can improved glycemic control vs. usual care     for young people with type 1 diabetes 12-20 in a diabetes camp environment.   "
110937|NCT01833884|"     More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional     polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless,     some patients relapse and others are resistant to any treatment. These patients represent     2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on     clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International     Prognostic Score) cannot always detect patients at risk.      New prognostic factors are required to screen out these high risk patients. Among available     biological factors, we will retain the cytokines secreted by tumor cells and cells from the     environment.      Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has     recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index     based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team     published the prognostic value of the decrease of TARC (CC Thymus and Activation-related     chemokine).      In daily practice, the early assessment of response by PET CT-scan is now an undeniable     prognostic factor. Early identification of no-response or relapse is, in fact, based on     clinical and imaging (PET-CT scan).      We propose to evaluate the decrease of cytokines concentration with a prognostic value (TARC,     IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early     follow-up. The dosage of these cytokines will be paired with radiological assessments.      A correlation between the decrease of cytokines plasma levels overtime and event-free     survival will be searched afterwards.   "
110938|NCT01833871|"     Colour Doppler sonography has also been evaluated in differentiating adenomyosis from     fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases had     vessel distributions different from those found in leiomyoma cases, in addition to a high     pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or intratumoral     signals while leiomyomas usually had peripheral scattered or outer feeding vessels.   "
110939|NCT01833858|"     A novel gonadotropin protocol for ovarian stimulation adds low-dose hCG (50- 200 IU) as a     source of LH (luteinizing hormone) in the late follicular phase .      This regimen reduces the number of small pre-ovulatory follicles which could reduce the risk     of OHSS(ovarian hyper stimulation syndrome). Adequate ovarian hormonal levels , oocyte     maturation, avoidance of a premature LH surge, and increased pregnancy rate are the other     benefits of this regimen.      HCG might also affect endometrial function, stimulate endometrial growth and maturation and     enhance the endometrial angiogenesis. These effects could extend the angiogenesis. These     results could lengthen the implantation Window.      Inhibin A is a heterodimer protein and does not begin to increase until just after the     increase in oestradiol in the late follicular phase, suggesting secretion by the dominant     follicle. Inhibin A secretion is regulated by LH and is associated with paracrine/autocrine     action on oocyte maturation. Moreover, it is related to follicular development and size,     serving as a marker of follicular maturation after IVF cycles .However, the role of hCG     supplementation during COH (controlled ovarian hyperstimulation)is still a matter of debate     and more studies is needed. Thus, the objective of this trial was to investigate whether LH     activity in the form of low dose hCG in GnRH (Gonadotropin releasing hormone)antagonist     cycles would improve the quality of oocytes, level of inhibin A and endometrial vascularity.   "
110940|NCT01833845|"     Proof-of Concept, Open-Label, Two-Stage Study without Direct Individual Benefit The proposed     study design consists of two treatment periods and one treatment arm. Treatment Period 1     involves the administration of RBV monotherapy for a period of 8 weeks and Treatment Period 2     involves administration of up to 16 weeks combination therapy with RBV plus HCQ.   "
110941|NCT01833832|"     Background:      - Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop     this disease live more than 5 years after being diagnosed. Those whose tumors have spread     inside their abdomen may have an especially poor outcome. In these cases, traditional     chemotherapy is not very effective. One possible new treatment is aggressive surgery with     heated chemotherapy. This type of treatment has been more effective for other types of cancer     in the abdomen. Researchers want to see this if approach can improve the outcomes of people     with ACC.      Objectives:      - To test the safety and effectiveness of surgery and heated chemotherapy for ACC.      Eligibility:      - Individuals at least 18 years of age who have advanced ACC.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. Heart function tests will be given. Imaging studies will be used to          locate the surgical sites before the operation.        -  Participants will have surgery to remove ACC tumor tissue. After the tumors have been          removed, they will have heated chemotherapy with cisplatin. The heat may help weaken any          remaining cancer cells and make them easier to destroy. It will also focus the treatment          on the tumor sites, rather than the whole body.        -  Participants will recover in the hospital for several days after surgery. They will have          regular follow-up visits to monitor the outcome of the surgery.   "
110942|NCT01833819|"     Opioids may attenuate postoperative hyperalgesia and postoperative nausea and vomiting. Our     hypothesis is: opioid-free total intravenous anesthesia with propofol, dexmedetomidine and     lidocaine infusions for laparoscopic cholecystectomy may achieve comparable hemodynamic     stability during laparoscopy, with lower postoperative analgesic consumption and incidence of     postoperative nausea and vomiting.   "
110943|NCT01833806|"     The study hypotheses is that the proportion of patients experiencing clinically significant     pain relief will be at least 30% greater than the proportion experiencing worsening pain.   "
110944|NCT01833793|"     MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is     to describe the acceptability of Amenorrhea in contraception indication of Mirena users     during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in     the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be     evaluated.   "
110945|NCT01833780|"     Study hypothesis: Intrapartum polimeraze chain reaction (PCR)of group B streptoccocus (GBS)     test is more accurate than Culture of GBS at 35-37 weeks gestation for GBS carriage.      The investigators will compare GBS culture and PCR results taken at 35-37 weeks gestation to     intrapartum PCR GBS and GBS cultures status.      The larger perspective of this trial is to check the possibility of replacing the GBS culture     screening program at 35-37 weeks gestation with a more accurate examination (PCR), avoiding     the changing GBS carriage status from the time of culture at 35-37 weeks to delivery.   "
110949|NCT01833728|"     The multimodal analgesia for postoperative pain aims for optimal analgesia through additive     or synergic drug effects. The multimodal analgesia results in the use of smaller doses of     opioids and lowering opioid-related side effects.      Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug     of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia     after major surgery.      NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side     effects.      In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely     used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter     renal function or cause hemorrhagic complications.      Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous     acetaminophen) associated with the analgesic effectiveness of nefopam could explain the     observed synergy of the combination.      The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and     analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and     propacetamol in patients undergoing laparoscopic nephrectomy.   "
110950|NCT01833715|"     The aim of this study is to compare the efficacy of methadone versus morphine in dealing with     postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia     (TIVA); Efficacy is defined in terms of the difference of milligrams in morphine used as     rescue analgesia postoperatively. Our hypothesis is that methadone is more effective than     morphine for postoperative pain treatment.   "
110975|NCT01833390|"     The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical     imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.   "
110976|NCT01833377|"     This study aims to investigate the applicability of caraway (black cumin) intake on the     treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to     examine the applicability of caraway product in terms of safety and efficacy.   "
110951|NCT01833702|"     The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older     who have access to a smartphone or tablet with Internet access daily.      The study will evaluate patient-reported comfort level with using a mobile device to record     their pain levels, as well as adherence to recording these levels daily.      The study will track patients' assessment of their pain, actions taken, and outcomes related     to pain management and provider involvement.      This study will attempt to collect information about differences in the use of two     traditional pain assessment modes (verbal scale and paper) versus the use of a pain     assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an     Android or iOS operating system.   "
110952|NCT01833689|"     The objective of this study is to assess the effect that dietary carbohydrates have on blood     sugar by measuring the glycaemic index. The glycaemic index is a comparison between the     effect of equal amounts of carbohydrate from a test food compared to a standard (in this case     glucose) on blood sugar.      Different foods that contain different carbohydrates have different effects on blood sugars.     This is of interest as a number of studies have shown that the level of sugar in the blood     after a meal relates directly to the risk of developing heart disease and diabetes. The aim     of collecting this data is to be able to give advice to people about the carbohydrates they     eat to reduce the risk of diabetes and heart disease.   "
110953|NCT01833676|"     Anaesthesia and surgery has become more common in the elderly as the population survives     longer. Anaesthesia in the elderly confers a higher risk which is related to the aging     process and the diseases that accompany seniority. As such, there is a need to provide     optimal anaesthetic management in order to minimize complications and risks perioperatively.     One of the changes associated with ageing is the progressive decrease in protective laryngeal     reflexes. Any depression of upper airway reflexes increases the chance of pulmonary     aspiration and compromises the maintenance of the airway.      Desflurane is an inhalational agent strongly favored due to its lower solubility in blood,     lean tissue and fat as compared to sevoflurane. This enables the agent to be quickly     eliminated at the end of surgery, with minimal metabolic breakdown, thus facilitating more     rapid emergence as compared to sevoflurane anesthesia in elderly undergoing general     anaesthesia. McKay et al conducted a study in 2005 in US, which showed that the choice of     inhalational agent itself can influence the return of protective airway reflexes. In the     study, the inhalational agent sevoflurane was found to cause significant impairment of     swallowing, in comparison with desflurane(1). However, the aforementioned study focussed on     the general population. As such, the purpose of this study is to determine whether the choice     of inhalational anesthetic (sevoflurane versus desflurane) has similar influence on the     return of protective airway reflexes in the geriatric population in Malaysia, and whether the     significance is greater in the elderly population.   "
110954|NCT01833663|"     This study is a multi-site, randomized, opened and parallel-controlled clinical study.      The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate     Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks.     Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and     various indices are evaluated.   "
110955|NCT01833650|"     The purpose of this study is to determine whether the use of honey mouthwashes in the     prevention of salivary side effects of 131I (radioiodine) therapy.   "
110956|NCT01833637|"     The purpose of this study is to assess whether using computerized screening questions can     improve how well we manage symptoms related to cancer and cancer treatments. Advance care     planning is a process in which teams of experts assist in with treatment plans, managing pain     and other symptoms, emotional issues, and end of life issues. With advances in technology, it     is now possible to get the patient's feedback directly and more often. It is thought that     repeated questionnaires completed by the patient will provide a better and more accurate     measure of the patient's needs and experiences but this has not been tested. This study is     designed to learn if using a computerized assessment repeatedly is better than standard     planning techniques.   "
110957|NCT01833624|"     An early and efficient enteral nutritional support could improve the clinical outcomes of     brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an     increased gastric residual volume frequently occurs in these patients.      Previous experimental studies have suggested that a small-peptide enteral feeding formula     could promote the gastric emptying compared to a whole-protein formula. An improved     gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily     caloric intake and enhance nutritional support of brain injured critically ill patients.   "
110972|NCT01833429|"     The contribution of this study is the unedited evaluation of the circadian autonomic profiles     of resistant hypertension with and without white-coat response.   "
111074|NCT01832077|"     To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment     of Diabetes retinopathy and Diabetes macular edema.   "
110958|NCT01833611|"     Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication,     histology improvement as well as low rate of emergence of resistant mutants. Out of range of     clinical recommendations for treatment of chronic hepatitis B (CHB), chronic HBV carriers     with persistently normal ALT and viral load more than 10^5 copies/mL have progression of     liver disease during long-term follow-up. In addition, certain proportions of these patients     do have significant inflammation and fibrosis in liver histology. This study will be able to     identify who are at risk of liver disease progression and evaluate efficacy of ETV regarding     improvement of liver histology during short-term (1-year) and long-term ETV treatment     (3-year).   "
110977|NCT01833364|"     By doing this study, the investigators hope to learn provide safety data that can be used to     generate a larger phase III clinical trial. If successful, it would promote the development     of a new treatment for PD in which patients are able to provide their own tissue as a source     of a supportive environment for the injured and dying cells and thereby possibly stopping the     progression of the illness or even improve the symptoms of PD.      The purpose of this research is to gather information on the safety and feasibility of nerve     graft implantation is. The results of this study will be shared with the University of     Kentucky, Center for Clinical and Translational Science (group providing financial support     for the study) and other federal agencies, if required.      The overall goal of this research is to develop a novel, regenerative treatment strategy for     idiopathic Parkinson's disease (PD) that is safe, cost effective and widely available to     patients.   "
110959|NCT01833598|"     Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a     person's ability to perform daily activities and recreation. Traditional conservative     treatments include activity modification, exercises, ice/heat, and medications and     corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which     the affected area is repetitively needled to disrupt pathological tissue and induce bleeding.     This turns a nonhealing chronic injury into an acute injury with enhanced healing capability.     Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the     affected area, also activating growth factors. There has been promising research in these     tendinopathy treatments but more research is needed.      The investigators plan to expand on prior studies to identify a reproducible and efficacious     treatment for chronic tendinopathy to reduce pain and improve function and quality of life.     Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT     with peritendinous PRP as a treatment for chronic tendinopathy.   "
110960|NCT01833585|"     The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized     autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with     critical limb ischemia.   "
110961|NCT01833572|"     This is an open-label, single-arm, phase II interventional clinical trial. The investigators     hypothesize that the application of EGFR-TKI, like gefitinib will be efficient and safe in a     neo-adjuvant setting. 42 resectable stage II-IIIa NSCLC patients with EGFR activating (19/21)     mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all     the participants' biopsy samples and confirmed in surgical resected samples. Eligible     patients will be given gefitinib 250mg for 42days followed with surgical resection of tumor.     Efficacy of preoperative gefitinib is based on radiographic (CT response/ORR), pathologic     (pathologic response), surgical (complete resection) evaluations, and safety is based on     adverse effect evaluations.   "
110962|NCT01833559|"     The study is to investigate the impact of blood glucose management at the first trimester of     pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic     disorder.   "
110963|NCT01833546|"     This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy in     subjects with solid tumors and in combination with gemcitabine in subjects with pancreatic     cancer.   "
110964|NCT01833533|"     The purpose of this study is to evaluate the safety and antiviral activity of     ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin     (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without     cirrhosis.   "
110965|NCT01833520|"     The goal of this clinical research study is to find the highest tolerable dose of radium-223     dichloride that can be given to patients with osteosarcoma.      Radium-223 chloride is designed to work like radiation therapy in cells that are actively     making bone. It is designed to target new bone growth in and around bone cancer and may kill     cancer cells.   "
110966|NCT01833507|"     Obesity is common in adults with complex medical problems with ensuing complications     afterwards. Obese patients suffer higher mortality and impaired functional status often as a     result of their obesity. One primary goal to reduce both obesity and improve functional     status is exercise. The investigators hypothesize that a simple exercise intervention with     limited behavioral goal-setting will reduce weight and increase functional status compared to     usual care. As a secondary measure, the investigators hypothesize that using this     intervention will reduce hospital admissions and ER visits.   "
110967|NCT01833494|"     The purpose of this study is to investigate the safety and efficacy for 52-week dosing in     hemodialysis patients with hyperphosphatemia.   "
110968|NCT01833481|"     In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total     Hip Arthroplasties (THA), it was determined that the investigators could simultaneously     capture in vivo sound and motion of the femoral head within the acetabular cup during     weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP),     metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound     analysis as an impulse excitation technique for testing hip conditions and for measuring     femoral head sliding in the acetabular component of human hip joints by acoustic means.     Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for     subjects implanted using various surgical approaches. It could be hypothesized that subjects     having various surgical approaches could lead to an increase or reduction of in vivo hip     separation. Therefore, the objective of this study is to analyze a total of 30 subjects     implanted with either an anterior (10 patients), anterior-lateral (10 patients), or     posterior-lateral (10 patients) surgical approach to determine if any of these surgical     approaches leads to less or more in vivo hip separation. All subjects will be analyzed under     in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.   "
110969|NCT01833468|"     Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the     SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The     functional status of the SpA patients are usually evaluated globally.The aim of this study is     to assess specifically the foot -related functional limitations of the SpA patients.   "
110970|NCT01833455|"     The purpose of this study is to determine if reduction in premature ventricular contraction     (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma     catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC     suppression in a randomized, double-blinded, crossover fashion.   "
110971|NCT01833442|"     The trial objective is to compare two very different meditation protocols (Kundalini Yoga and     Relaxation Response meditation techniques) to help the OCD treatment.   "
110973|NCT01833416|"     Although the accumulated knowledge regarding Cytomegalovirus (CMV) infection increased     substantially over the past years, several issues still deserve further investigation. The     epidemiology of this disease has been changing, perhaps influenced by new immunosuppressive     strategies currently used and growing and widespread use of prophylaxis. The knowledge of the     CMV viral load kinetics, using a polymerase chain reaction (PCR-based assay), among renal     transplant recipients not receiving any prophylactic therapy will allow the determination of     risk factors for and the impact of earlier intervention on CMV infection and disease. The     goal is to ultimately improve the clinical outcomes for renal transplant recipients.   "
110978|NCT01833351|"     This Phase I study will be conducted in 2 parts to examine safety and pharmacokinetics of     escalating doses of intravenous ascorbic acid (AA) first in healthy volunteers followed by     evaluation in oncology subjects. The study will be conducted in the Program in Integrative     Medicine Infusion Clinic at the University of Kansas Medical Center in conjunction with the     Program in Integrative Medicine, Kansas Cancer Research Institute, Department of Pharmacy,     Department of Medical Oncology, the Division of Surgical Oncology,and with consultants from     the NIH, and FDA.   "
110979|NCT01833338|"     The accuracy of coronary plaque characterization with Multi-slice computed tomography as     compared to intravascular ultrasound and optical coherence tomography will be investigated in     patients presenting with acute coronary syndrome without ST-elevation.   "
110980|NCT01833325|"     This is a pilot study to determine if proton radiation therapy can provide effective and safe     treatment for subfoveal neovascularization membrane (SNVM). The study will include adult     patients over the age of 50 with macular degeneration, who have subfoveal neovascularization     membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of     this study are to see if the growth of neovascular membranes can be stopped and overall     vision improved with the use of protons and assess the side effects associated with this     treatment.   "
110981|NCT01833312|"     The purpose of this study is to determine if systemic cooling to a target temperature of 34     to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves     functional outcome at 3 months in patients with acute ischaemic stroke.   "
110982|NCT01833299|"     Hepatocellular carcinoma (HCC) is the 6th most common cancer and the third most frequent     cause of cancer death worldwide. Hepatic resection (HR) has been the standard treatment     modality for HCC aiming at clinical cure. In both Europe and Unit States proposed guidelines     for HCC, HR was recommend only for patients with a single HCC lesion and preserved liver     function . Unfortunately, only 10%-30% of HCCs are amenable to such curative surgical     resection at the time of diagnosis, because of tumor multifocality, portal vein invasion, and     underlying advanced liver cirrhosis . Alternatively, transarterial chemoembolization (TACE)     has become the most popular modality for palliative treatment for the other patients.     However, the long term outcomes were generally poor for HCC patients treated with TACE.      Recently, sorafenib has shown some promises in improvement of 3-month survival among patients     with advanced HCC. It is claimed that sorafenib has become the standard of care for patients     advanced HCC.      Thus, the purpose of this study was to prospectively compare the effectiveness of sorafenib     combined with TACE with that of TACE alone in the treatment of unresectable HCC .   "
110998|NCT01833091|"     Effects of creating an artificial night on physiological changes, weight and feeding     tolerance in preterm infants.      Introduction:Nowdays,with medical advances in intensive care increased chance of survival in     premature infants.One of the major concerns exposure to high light levels in neonate &     subsequent it is increase in metabolism rate.So,this study was conducted to determine the     effect of creating an artificial night on physiological changes, weight and feeding tolerance     in preterm infants.      Methods: This is a randomized clinical trial dual group study, 38 preterm infants     (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated     within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the     weight and the weight of each group were randomized into artificial night(dark period was     from 19 to 7 during incubator was covered with linen cloth & light period was from 7 to 19     removed the cover) and control groups(continuous lighting). Mothers & infants through     questionnaires,interviews,observation & document completion, changes in physiologic & weight     befor entering the study & then physiologic changes twice a day,weight & feeding tolerance     were collected daily.Data were analyzed using spss v.16 software.   "
111075|NCT01832064|"     The development and pilot testing of a self-management program that would be delivered in a     one time mailing.   "
110983|NCT01833286|"     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial     hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence     of HCC after partial hepatectomy is common and was reported to be more than 77% within 5     years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC     recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after     initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a     small proportion of patients with HCC recurrence (10.4-31%), either because of the poor     functional liver reserve or because of widespread intrahepatic recurrence. In the past two     decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality     and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0     cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year     survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is     particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors     are usually detected when they are small and PRFA causes the least deterioration of liver     function in the patients. Our previous retrospective study demonstrated that RFA was     comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined     with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with TACE     is superior to re-resection for recurrent small HCC. The aim of this retrospective study is     to compare the outcome of reresection with TACE+RFA for small recurrent HCC after partial     hepatectomy.   "
110984|NCT01833273|"     In order to test the investigators hypothesis that 8 teaspoons of POLYMVA is safe in a     population of patients with grade IV brain astrocytoma (glioblastoma multiforme), the     investigators will conduct an open-label, prospective, un-blinded study. The investigators     expect that at least 70% of subjects will tolerate the supplement and complete the trial. The     investigators expect no Serious Adverse Event to occur during this trial which is     attributable to study compound. During this study, the investigators will also collect other     qualitative data to be utilized for future double-blinded studies which will be aimed at     determining whether grade IV astrocytoma patients who receive PolyMVA achieve a better     quality of life during their chemo-therapeutic regimens versus grade IV astrocytoma patients     who do not receive PolyMVA.   "
110985|NCT01833260|"     The aim of this study was to evaluate the effect of listening to ambient music on the     perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary     disease patients.   "
110987|NCT01833234|"     The investigators are developing a questionnaire that can quickly measure the impact that     epilepsy has on a person's life. This questionnaire will be useful in following whether the     impact of epilepsy increases, decreases or stays the same over time. The results also may     point out areas that would benefit from discussion or attention in visits with your doctor.   "
110988|NCT01833221|"     The purpose of this study is to determine the physiology of nerve healing and the     neurotization of the facial muscles after lengthening temporalis myoplasty.   "
110989|NCT01833208|"     This pilot clinical trial studies the impact of radiation therapy on the immunogenicity of     Sipuleucel-T. Patients with castration recurrent prostate cancer who are eligible for     treatment with Sipuleucel-T and who have bone metastases are eligible.   "
110990|NCT01833195|"     The objective of this registry is to observe short and long term clinical outcomes in heart     transplant recipients who receive regular AlloMap testing as part of allograft rejection     surveillance.   "
110991|NCT01833182|"     Phase 1 of the study:      Falls are the leading cause of preventable injury, long term disability, premature     institutionalization and mortality in the older adult population. Promising preliminary     research suggests that modifications to the home can potentially reduce the incidence of     falls in the elderly. The purpose of this study is to gather data necessary to design a     definitive trial of a home modification intervention for older adults at risk for fall. The     specific aims are to 1) estimate the efficacy of an intensive tailored environmental     intervention to reduce functional decline among community-dwelling older adults; 2) gather     the data necessary to design a definitive clinical trial of an intensive tailored     environmental intervention to reduce the cumulative incidence of falls among     community-dwelling older adults; 3) examine the direct cost of intensive tailored home     modification. A pilot randomized controlled trial will be conducted with 40 older adults who     have experienced a fall resulting in an emergency room visit.      Phase 2 of the study:      Our long-term objective is to prevent falls for these older adults at high risk by removing     hazards in their homes. Development of an effective intervention for fall reduction could     have an immediate impact for this population and high public health significance. Intensive     home hazard removal has been established as an effective environmental intervention for the     prevention of falls; however, none of the published studies have been conducted in the US,     and no study has adequately controlled for biases. The investigators propose a     double-blinded, randomized sham-controlled clinical trial to determine the efficacy of an     intensive tailored home hazard removal intervention to reduce the cumulative incidence of     falls among 110 community-dwelling older adults who visit the emergency department (ED)     because of a fall. This three year study will be the first to utilize a sham control group     and a double-blind, randomized study design. The investigators will intervene with a     high-risk group of community-dwelling older adults who visit an ED after a fall. The primary     hypothesis will be tested by comparing the 12-month cumulative incidence of falls in an     intensive tailored home intervention group with falls in a sham control group. Falls will be     operationalized as unintentional movements to the floor, ground or object below knee level.     The secondary hypothesis will be tested by comparing total number of falls, number of     injurious falls, fear of falling and performance in daily activities between the intervention     and sham control group.      The primary aim of the proposed study is to:        1. Compare the efficacy of an intensive tailored home hazard reduction intervention to sham          treatment on the cumulative incidence of falls over 12 months for older adults who visit          the ED after a fall.           Hypothesis 1: The cumulative incidence of falls over 12 months will be lower for the          intensive tailored home hazard removal group compared to the sham control group.           The secondary aims of the proposed study are to:        2. Determine if intensive tailored home hazard reduction intervention is superior to sham          treatment on secondary outcomes including: total number of falls, number of injurious          falls, fear of falling and activities of daily living (ADL) performance.           Hypothesis 2: The investigators hypothesize that the intensive tailored home hazard          reduction intervention group will experience fewer total falls, fewer injurious falls,          less fear of falling and improved ADL performance compared to the sham control group.        3. Characterize intensive tailored home hazard reduction interventions including the          frequency of environmental modification by type and location in the home and its direct          costs. The investigators will also conduct subgroup analysis of type, location and cost          of home modifications by race and gender.      The proposed study is innovative because it provides intensive, individualized prescriptions     of home hazard removal and because it provides a quick response to a fall. It is also the     first double-blind trial of the effect of environmental modification on falls and, to our     knowledge, is the first collaboration between occupational therapy and emergency medicine on     fall reduction strategies in the US.      The results of the proposed study will provide new evidence about the effectiveness of     intensive tailored home hazard removal to reduce falls. This study has the potential to     provide public health guidelines for the delivery of home hazard removal, decrease the health     care costs associated with falls and to provide evidence for guiding public health policy for     older adults who have fallen.   "
110992|NCT01833169|"     The purpose of this signal seeking study is to determine whether treatment with BKM120     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic     malignancies to warrant further study.   "
110993|NCT01833156|"     In lymphedema there is increase in water content of the tissue. We studied a device     (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the     apparatus is commercially available, no validation study had been performed in vivo with     local edema.      We designed a validation study for inter- and intra observer variability and the     reproducibility in vivo by histamin induced local edema   "
110994|NCT01833143|"     The purpose of this study is to test the drug Bortezomib to see how well it works. The     investigators want to find out what effects, good or bad, it has on patients with a limited     smoking history or who have a specific mutation associated with their lung cancer.   "
110995|NCT01833130|"     This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I)     Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA     (BOTOX®) in adults with chronic migraine.   "
110996|NCT01833117|"     The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the     integrity of tear film in adults with a history of dry eye in both eyes.   "
110997|NCT01833104|"     The purpose of the study is to look at the long term effects of a complex socio-affective     mental training program on a neuroscientific-, hormonal-, behavioral-, biological, and     subjective measures-level. The training protocol consists of a variety of meditation and     other mental health techniques, which are trained over the period of 3-9 months (13 weeks per     Module; 1-3 Modules)   "
110999|NCT01833078|"     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the     brain. The investigators already know that a single dose of Ghrelin improves food intake     immediately after the dose in frail older people. In this study, the investigators are trying     to find out if repeated daily doses of ghrelin will help frail older people improve food     intake for multiple days in a row.   "
111000|NCT01833065|"     12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with     Chronic Idiopathic Constipation.   "
111001|NCT01833052|"     This prospective, randomized study was designed to investigate the benefit of using a     Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic     valve implantation (TAVI) with a Medtronic CoreValve®.   "
111003|NCT01833026|"     Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that     makes it harder to breathe over time. To date, there is no cure for COPD, but it can be     managed when diagnosed and proper medical care is provided.      The purpose of this study is to determine if diagnosis and guided therapy with the use of     spirometry is related to better patient outcomes (the condition of a patient's health)     compared to usual care which may or may not include the use of spirometry. Spirometry is a     standardized test used in medical practice that measures how much air your lungs can hold and     how forcefully you can breathe out.      For this study, the investigators will compare two groups: 1) intervention (treatment) group     and 2) usual care group (control). The intervention group will have a spirometry test and the     results will be provided to the primary care physician. The usual care group will not     initially have a spirometry test. Both groups will be followed for outcomes.   "
111004|NCT01833013|"     Nowadays, one in six couples consults for fertility problems. If the standard examination and     tests do not reveal any cause of infertility, the woman may undergo a laparoscopic     exploration which reveals endometriosis in more than 50% of cases.      Endometriosis is an inflammatory disease defined as the presence of endometrial tissue out of     the uterine cavity. It is frequent (1 in 10 women) and associated with a high economic burden     (22 billion dollars in 2002 in the USA) and important decrease in quality of life.     Physiopathological mechanisms and risk factors for endometriosis are not well identified.      A woman with endometriosis is 20 times more at risk of infertility. Fecundity rate of a     25-year-old couple is about 15 to 20% in the general population and only 2 to 10% in case of     endometriosis.      There are many manifestations of this disease (infertility, pelvic pain) and the     anatomo-clinical correlation is not good. The presently used international classification     (American Fertility Society revised in 1985, AFSr) does not predict the chance of pregnancy.     New scores such as the Endometriosis Fertility Index (EFI) have been proposed to do so, but     need to be validated. Treatment for endometriosis-related infertility is not consensual.      A prospective cohort study would give access to clinical data of patients followed in our     center, so as to identify clinical factors predicting pregnancy and to help treatment     decision for women with endometriosis suffering from infertility.   "
111005|NCT01833000|"     The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR)     for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding     and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).   "
111056|NCT01832337|"     Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The     investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce     heart and gastrointestinal function injury in middle-aged and elderly patients undergoing     elective laparoscopic colorectal surgery.   "
111006|NCT01832987|"     Rationale:      Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real     challenge as failure in response to treatment and serious side-effects are frequently     encountered. New, more effective drugs with less side effects are therefore urgently needed     to solve this problem. Although several new drugs against TB are in the pipeline, physicians     currently have limited treatment options for treatment of complicated MDR/XDR-TB cases.     Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB.     Co-trimoxazole consists of sulfamethoxazole and trimethoprim. Sulfamethoxazole could be     effective in the treatment of tuberculosis as shown by Forgacs et al. and Huang et al.      Furthermore, with dried blood spot (DBS) analysis, the exposure to co-trimoxazole could be     analyzed with only some blood drops withdrawn with a finger prick on paper. This paper is     suitable for storage, transportation and subsequently analysis without additional cooling or     storage requirements.      Objective:      The main objective of this prospective clinical trial is to evaluate pharmacokinetics of 960     mg co-trimoxazole in TB patients. This clinical trial will provide important information on     PK of co-trimoxazole in TB patients for future studies.      The second objective is to calculate the T>MIC and AUC0-24h/Minimal inhibitory concentration     (MIC) ratio as efficacy predicting parameter. Furthermore, the analysis of dried blood spots     will be clinically validated by comparing results of blood samples withdrawn from venous     blood versus withdrawn by finger prick and transferred to filter paper. Retrospectively, data     from this study can be used for limited sampling strategies for co-trimoxazole based on a     pharmacokinetic population model constructed from the full PK curves of the patients.      Study design:      A prospective pharmacokinetic study.      Study population: 12 TB patients.      Intervention: on 4 to 6 days, 960 mg co-trimoxazole daily will be added to the normal     treatment regimen.      Main study parameters/endpoints:      The pharmacokinetic parameters (Vd, Cl, AUC, etc) of co-trimoxazole are the primary endpoints     of the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most     likely the best predictive parameters for efficacy of co-trimoxazole treatment and will be     calculated for a range of M tuberculosis isolates.   "
111007|NCT01832974|"     IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to     specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to     find one that may be safe and effective against cancer that has returned, spread to other     organs, or that cannot be surgically removed.      Participants will receive physical exams and report side effects. Blood and urine samples     will be collected. Imaging studies, tissue samples, and other tests will be used to study the     tumor before the start of treatment and during the study. IL-13-PE therapy will be given to     each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles.      The study will be done in two parts, with a six-month period between them. If the cancer     continues to grow, participants will stop taking IL-13-PE. If the cancer continues to shrink     or not grow the study will continue, even into a follow-up period after the second part of     the study.      The first part of this study will determine how much IL-13-PE can be tolerated. For this     part, the study is recruiting adult patients with various types of cancer. After six     participants have taken the lowest dose with no more than one experiencing dose-limiting     toxicity, two participants may begin the study taking the medium dose. If they tolerate the     medium dose for a month, up to four more may begin at that dose. When at least three     participants have tolerated the medium dose, two may attempt the highest dose. When they have     tolerated the highest dose for one monthly cycle, 1-4 more may begin the study, receiving the     highest dose.      Adrenal cortex cancer (ACC) is a rare tumor in the gland above the kidney. It affects only     1-2 people per million each year and causes hormone problems. This tumor affects children     under age 5 and adults aged 30-40, causing death within five years for up to 80% of them.     During the second part of the study, all participants will be ACC patients. They will receive     the highest dose tolerated during Part 1 on days 1, 3, and 5 of each monthly cycle for up to     four months.   "
111008|NCT01832961|"     Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is     not fully reversible, and is usually progressive and associated with an abnormal inflammatory     response of the lungs to noxious particles or gases, most commonly cigarette smoking. The     disease affects not only the large central airways but also the small, more peripheral     airways deeper into the lung, defined as less than 2 mm in diameter.      Besides medical treatment, physiotherapy plays a major role in treatment and various methods     have been suggested to remove airway of secretions. The flutter is a simple and small device     shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency     oscillation when the expired air passes through it. These vibrations are thought to mobilise     airway secretions facilitating their clearance and improving breathing.      Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have     previously been used to investigate the efficacy of flutter devices. However, spirometry     assesses the damage of larger airways but not small airways, also known as the silent zone     which, crucially, are specifically damaged in COPD.      In this study the investigators hypothesise that because the flutter helps clear the airways     from the excessive thick mucus produced by COPD patients, these patients may find it easier     to breathe and have lower resistance to moving air in and out of their lungs.      The main objective of this study is to compare the effect of a flutter or a sham device on     small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary     to other common blowing tests, measures small airway resistance during normal breathing.      In addition, because COPD is characterised by inflammation, the investigators would also like     to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway     inflammation. This will give to investigators an insight into the relationship between airway     inflammation and small airway function.   "
111009|NCT01832948|"     This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in     untreated metastatic colorectal cancer patients, and to find the markers that may predict the     efficacy.   "
111120|NCT01831479|"     This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and     Olmesartan in healthy male volunteers   "
111010|NCT01832935|"     Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle     intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail     to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are     generated to improve glycemic control .New insulin analogs are generated to improve glycemic     control,However, the cost of these analogs is a major problem .The aim of this piggy back     evaluation was to assess the effect of Glargine insuline versus NPH plus regular human     insulin on metabolic control as well as its cost-effectiveness in people with type 2 diabetes     in the Iranian setting.   "
111011|NCT01832922|"     This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR)     in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia     (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are     FDA approved for this indication. However, full dose bendamustine is associated with     significant hematologic toxicity and a high rate of infectious complications in unfit     patients and patients with significantly impaired renal function. This study will attempt to     optimize and define adequate and safe treatment protocols for these patients with     comorbidities and/or renal dysfunction.      The study will accrue two independent patient cohorts which will follow a standard Phase I     design. Patients with CLL who have significant comorbidities with or without minor renal     dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with     significant renal dysfunction (CrCL<40 mL/min) will be accrued onto Cohort 2. Once the     maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled.      There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients     will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to     9 patients with renal dysfunction will also provide samples for bendamustine PK analysis.      Accrual of both patient cohorts will occur simultaneously and will take place at two centers:     Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI). Coordination of     accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V. Danilov.   "
111012|NCT01832909|"     The objective of this study is to measure the energy value of walnuts in the human diet and     study molecular mechanisms that may help explain the beneficial health effects of walnuts.     The hypothesis is that there will be less metabolizable energy in walnuts due to decreased     fat digestibility.   "
111016|NCT01832857|"     This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients     with advanced and/or metastatic solid tumors for whom there there is no available therapy to     provide clinical benefit or for those who have refused further standard therapy. The primary     outcome measure is Overall Survival (OS). The secondary outcome measures are: Response Rate     (RR), Progression-Free Survival (PFS), and safety.   "
111017|NCT01832844|"     The aim of this care protocol is to study the effects of scan to help epidural infiltration     realization, in presumed difficult patients suffering from sciatica.      These scans are already performed in our Rheumatology Department but our objective is to     evaluate objectively its contribution for patients and doctors.      Epidural infiltration in young patients, with an easy anatomical identification, causes     generally no technical difficulties, therefore this protocol will only include patients     presumed to have a difficult infiltration, that means those aged more than 60, and/or with     BMI > 30 and/or suffering from scoliosis.      This study concerns patients who are hospitalized in Rheumatology Department (Hospital of     Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.      Patient will be randomized at Day 0, before infiltration. This latter will be performed in     accordance to current practice.      Tolerance data (pain and satisfaction) will be collected just after the infiltration and     eventual complications will be reported within 48 hours after infiltration.      Following treatment of lombosciatic will be realized through hospitalization, as usual.      Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the     musculoskeletal clinical exam and it has already changed our rheumatology practices. The     investigators hope at the end of this study, that results would confirm that scan can be a     help in practice to perform epidural infiltrations.   "
111018|NCT01832831|"     One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to     75% report urinary incontinence. There are many hypotheses about the exact cause of post     prostatectomy stress incontinence (PPI). Existing studies have focused on surgical or     cadaveric dissections to define structures responsible for PPI. Contemporary 3T MRI now     allows three dimensional, sub-millimeter resolution of the human pelvis and clearly     demonstrates pelvic anatomy without the distortion of dissection. It is our overarching     hypothesis that PPI is multifactorial and occurs because of a combination of specific     anatomical and functional impairments. We propose conducting a case control study with     matching for age and race to compare the MRI anatomy and urinary tract function on     urodynamics between 20 men with PPI (cases) and 20 men who are continent post prostatectomy     (controls) who are all a minimum of 12 months post surgery. We will use static and dynamic     MRI at 3 Tesla to make objective measurements of the bladder neck, external urethral     sphincter, pelvic floor, urethral anastomotic fibrosis, and urethral hypermobility- all     believed to play a large part in continence. Multi-channel urodynamic studies will also be     performed to assess the leak point and maximum urethral closure pressure. All cases and     controls will complete standardized questionnaires - the AUA symptom index and the     Incontinence Severity Index as a quality of life measure. This study is needed to provide     critical information about causes of male PPI, a quality of life altering voiding     dysfunction, and will assist with the advancement of pharmacological and surgical treatment     of this disease.   "
111019|NCT01832818|"     The objective of this study is to evaluate long-term safety and effectiveness of the NuNec®     Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE     marked and commercially available in Europe.   "
111020|NCT01832805|"     50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be     treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each     stimulation day, a given patient shall receive 5 sessions with a between session delay of 10     to 15 minutes. Patients will be selected using the structured Mini-International     Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because     concomitant antidepressant treatment can confound outcome results, all patients will go     through a medication washout before entering the study and they will be free from any     antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the     treatment protocol. Only habitual benzodiazepine agents will be allowed.      All patients will be closely matched for gender and age with 50 never-depressed     medication-free healthy volunteers. Only baseline measurements will be collected: no     volunteer will undergo the treatment.      We expect that real Theta burst treatment and not sham will result in a significant and     clinical meaningful response.   "
111021|NCT01832792|"     Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge     eating disorder, and atypical variants of these disorders. The current study proposes to     investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using     a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of     cost-effectiveness made. Results are proposed to be disseminated locally and internationally     (through submission to conferences and peer-reviewed journals), and will hopefully inform     local service provision.      Please note that we are only able to offer the intervention to individuals who are currently     registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust     - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of     Wiltshire.   "
111022|NCT01832779|"     Achalasia is a chronic disease of altered esophageal motility with resulting functional     obstruction to the passage of food leading to poor quality of life and significant morbidity.     The two main treatments available in the US are endoscopic balloon dilation and surgical     myotomy. Each therapy has advantages and drawbacks and at present both are considered a first     choice approach depending on patient preferences and local expertise. Surgical myotomy     provides long lasting improvement in dysphagia but even when done laparoscopically is     invasive and complex. Extensive acid reflux resulting in significant morbidity is routinely     seen after surgical myotomy and additional anti-reflux operation is typically done at the     time of the myotomy. Endoscopic balloon dilation is a simple minimally invasive outpatient     procedure but improvement of symptoms tends to be shorter in duration and repeat dilations     are commonly needed. Both therapies improve on dysphagia but tend to provide suboptimal     control of chest pain which is one of the cardinal symptoms of achalasia.      The peroral endoscopic myotomy (POEM) was first introduced in Japan to address the suboptimal     results with endoscopic balloon dilation and surgical myotomy. POEM is incisionless minimally     invasive but in addition may have some further advantages over surgical myotomy including     unlimited length of the myotomy with expected better control of chest pain and preservation     of the anatomical anti-reflux barrier (angle of His and the cruse of the diaphragm) with     expected lower incidence of acid reflux.      In Japan POEM has become the preferred modality for therapy of achalasia due to the excellent     results and exceptional safety record. In the US, dedicated POEM devices were approved by the     FDA just recently. As a result the bulk of the published data comes from Japan and very     little is known regarding outcomes in US population. Therefore the investigators want to     prospectively record our experience with POEM as done as part of routine medical care in US     population. This will be a data recording study. All patients will receive standard medical     care and no experimental interventions will be performed.   "
111023|NCT01832766|"     Approximately 25% of people with schizophrenia abuse marijuana. These people may be using     marijuana to self-medicate symptoms such as hallucinations (hearing or seeing things that are     not heard or seen by others) or delusions (false beliefs i.e. people are harassing or     persecuting them) or the depressed and anxious feelings brought on by these symptoms.     Currently, it is unknown whether marijuana makes schizophrenia better or worse. Marijuana     intoxication in people without schizophrenia generally causes decreased recall of words, may     decrease reaction time and decrease inhibition. Additionally, marijuana may cause     distractibility as demonstrated by difficulty keeping their eyes on a moving target and     difficulty inhibiting their response to repetitive tones. However, marijuana may have     different effects in schizophrenia. Receptors for cannabis (marijuana) are concentrated in     the brain and maladjustment of the cannabinoid system may be associated with the difficulty     in thinking found in schizophrenia. The proposed research project examines if clinical     symptoms, learning, memory, inhibition and distractibility are improved or made worse by the     acute ingestion of tetrahydrocannabinol (THC).   "
111024|NCT01832753|"     The purpose of this research study is to learn about the effects of treating subclinical     hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down     syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will     improve cardiometabolic health and quality of life.   "
111025|NCT01832740|"     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity     typically occuring during SWS has been implicated in the consolidation effect. In this study     we investigate if the consolidation effect can be amplified by the application of a weak     transcranial oscillatory electric current within the frequency range of SWS in humans     (0,7-0,8 Hz) during nocturnal SWS.   "
111026|NCT01832727|"     The primary objectives are as follows:      Phase 1b:        -  To determine the maximum tolerated dose (MTD) of oprozomib given orally, once daily, on          2 different schedules.        -  To evaluate safety and tolerability      Phase 2:        -  To estimate the overall response rate (ORR).        -  To evaluate safety and tolerability   "
111027|NCT01832714|"     This study is designed to evaluate the use of a collection of tests that measure the eye     response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI. The     tests use highly precise measurement tools to assess various neurologic functions. (For     example, high-speed cameras to record eye movement, high-end motors to precisely spin and     move the subject, comprehensive analysis to stitch together the stimulus and the response.)      Hypotheses:        1. A battery of oculomotor, vestibular and reaction time tests will generate variables that          when properly weighted and run through a given multi-variant analysis, will separate the          subjects into one of two groups, mTBI or not-mTBI.        2. A battery of neurologic assessment tests including reaction time, vestibular and          oculomotor tests taxing a range of neurologic functions and executed using one or more          of the I-Portal® family of devices, will generate responses that, when used by a trained          physician, can aid in the diagnosis of an mTBI.   "
111151|NCT01831063|"     Caregivers of children with seizures receiving simulation based seizure management teaching     in addition to the traditional seizure teaching will report more confidence with seizure     management and demonstrate a higher level of performance with seizure management.   "
111029|NCT01832688|"     A national survey in Niger found that women and children are at risk of undernutrition and     that many pregnant women don't visit health centers during pregnancy as often as is     recommended. The aim is to assess the nutritional and health status of pregnant women in the     Zinder region and to understand their knowledge, attitudes and practices related to health     and nutrition during pregnancy. In collaboration with the Medical District of Zinder the     prenatal care services will be optimized and the programmatic impact on gestational weight     gain and anemia prevalence will be assessed.   "
111030|NCT01832675|"     In this project the investigators want to compare a new anaesthetic method during upper     gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new     method is a lozenge containing bupivacaine, and the traditional method is a lidocaine spray.   "
111031|NCT01832662|"     Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic     acids) and bioavailability of these bioactive compounds is now somewhat well understood. In     addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence     remains to be observed in vivo. The objective of this trial is to understand if regular (10d)     coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and     plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as     beneficial as the whole beverage in reducing oxidative stress compared to placebo   "
111032|NCT01832649|"     The purpose of this study is to evaluate if exercise added to usual treatment improves     cocaine dependence treatment. The primary objective of this study is to investigate if     exercise can facilitate cocaine craving reduction. The secondary aims are to evaluate if     exercise can reduce negative mood states, improve quality of life and facilitate abstinence     of cocaine.   "
111033|NCT01832636|"     Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea     and undernutrition in developing countries. These include intestinal inflammation, mucosal     damage, and alterations in intestinal barrier function that lead to malabsorption, growth     failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea.     Recent studies from Northeast Brazil demonstrate the benefits of a novel     alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the     recovery of damaged intestinal barrier function in cell culture, animal models, patients with     AIDS, and underweight children.      Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves     short-term gut integrity and weight velocity 4 months after therapy in a group of     undernourished children from Northeast Brazil. Intervention and Mechanisms of     Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed     to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves     intestinal barrier function, intestinal inflammation, and nutritional status in children at     risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts     these benefits?   "
111034|NCT01832623|"     Vitamin D is not seen anymore only as a phosphocalcic hormone, but also as having an effect     on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular     protection).      The link between vitamin D deficiency and osteomalacia lesions is well-known. In paediatrics,     systematic vitamin D supplementation of infants and toddlers, associated with milk     enrichment, has allowed an almost total disappearance of rickets. Vitamin D repletion was     defined as the minimal concentration that enables the prevention of rickets in children and     osteomalacia in adults, that is approximately 8 ng/mL (20 nmol/L). However, in 2010, most of     the international experts agreed to set minimal threshold of 25 OH vitamin D serum     concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L)     to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D     insufficiency in adults. In the paediatric population, the consensus is less obvious and we     consider that a serum concentration of minimum 20 ng/mL is necessary.      A study on more than 200 children from Lyon, followed in the paediatric nephrology unit and     having a renal function normal or sub-normal, demonstrated an important prevalence of vitamin     D deficiency (75%) in adolescents and pre-adolescents.      Concurrently, the appearance of new bone imaging techniques (especially high-resolution     peripheral quantitative computed tomography HR-pQCT) improved bone status evaluation in a     non-invasive manner.      Given the new pathophysiological data on pleiotropic role of vitamin D (bone, cardiovascular     system, adipose tissue) and given the proportion of French children possibly suffering from     vitamin D deficiency, it seems urgent to actualize current recommendations regarding     systematic supplementation in vitamin D. This transversal study on 200 healthy children and     adolescents will allow to have an overview of vitamin D status in French healthy children and     adolescents, studying with non-invasive, safe, reliable and innovative tools, the theoretical     targets of vitamin D (bones, cardiovascular system and nutritional status); and then to lay     the foundations of therapeutic trials aiming to evaluate the mode of vitamin D     supplementation for healthy children and adolescents; while having a cohort for HR-pQCT     measurements, that will allow us to have French reference range in a 10-17 year-old     population, for this innovative, non-invasive and low radiation exposure technique.   "
111035|NCT01832610|"     Patients will be approached to participate in this PAS after the HeartWare® Ventricular     Assist System receives PMA approval for the indicated use as a bridge to cardiac     transplantation.      Patients who participated in prior trials will be approached for this PAS as follows:        -  Patients who are on continued HeartWare® System support, (original or exchange device)        -  Patients who have been explanted for transplant or recovery and have not yet completed 6          months of follow-up      Patients who participated in prior trials who will not be approached to participate in this     follow-up study include:      • Patients who have been explanted for transplant or recovery and have completed at least 6     months of follow-up (documented in the prior IDE trial).      No new patients are being screened or implanted with the HeartWare® System for this trial, it     is a follow-up trial only.   "
111036|NCT01832597|"     The purpose of this study is collect and evaluate the clinical experience reached in Italy on     the use of bendamustine alone or combined with rituximab as treatment of patients with     relapsed or refractory chronic lymphoproliferative disorders.   "
111037|NCT01832584|"     This is a 3-arm double blind placebo controlled study to investigate the effect of Red Grape     Cell (RGC) powder containing all the matrix of polyphenols that can be found in red grapes.     polyphenols have several beneficial effects on various body systems, are present in many     edible foods, and are considered safe for human consumption by regulatory authorities. Animal     and human studies suggest a potential for polyphenol-rich compounds in enhancing     mitochondrial activity and exercise capacity. However, the effect of RGC on exercise     performance in humans had not yet been tested. A special population where increasing     performance is highly sought are competitive athletes. The aim of the current study is to     investigate the effect of RGC on measures of aerobic fitness, body composition and mood in     trained male cyclists   "
111038|NCT01832571|"     This pilot, open-label, prospective study will determine the feasibility of integrating     pre-exposure prophylaxis (PrEP) into existing HIV prevention programs for female sex workers     and if women who are enrolled in those programs will adhere to the daily PrEP regimen of     Truvada®. This study will enroll 500 HIV antibody negative female sex workers in Eldoret and     Nairobi, Kenya.   "
111039|NCT01832558|"     In a prospective single centre placebo-controlled trial over ten weeks, 24 CKD II-III     patients (eGFR 30-89 ml/min per 1.73 m2) with DM II will be randomized to enalapril 20mg per     day after a two week run-in phase. Thereafter, patients will either receive eplerenone 25mg     (n=12) or a placebo (n=12) for eight weeks. Eplerenone will be increased to 50mg under close     monitoring of serum potassium levels. Employing a novel mass-spectrometry ( MS)-based method,     quantification of up to 10 different Ang metabolites (Ang I, Ang II, Ang 1-7, Ang 1-9, Ang     2-10, Ang 1-5, Ang 2-7, Ang 3-7, Ang 3-8 and Ang 2-8) will be performed simultaneously out of     blood sera (after run-in phase and after 10 weeks).   "
111040|NCT01832545|"     The aim of PICO study is to design an aquatic exercise program specific for obese individuals     with knee osteoarthritis which the main goals are OA symptoms management and the improvement     of physical fitness. The author's opinion is that the musculoskeletal pain is the main     constraint for any kind of mobility and its control should be considered as an important goal     in the weight management's programs. Therefore the PICO project proposes an aquatic exercise     program to controlling pain and other symptoms management, showing that it is possible to     live with the disease, and motivating the change in lifestyle, thus preventing the     installation or worsening of KOA. In this way, five hypotheses were formulated: H1. 3 months     of aquatic exercise is enough to improve KOA symptoms and functionality in obese individuals;     H2. The gait parameters of obese individuals with KOA can be improved by aquatic exercise;     H3. Beyond the exercises skills, aquatic exercise group classes can work with an educational     component, promoting lifestyles changes. H4: Pain reduction and a better psychological status     can lead an increase of functionally, increasing amount of physical activity. H5: Even if the     main goal is not weight management, the aquatic exercise program can lead a weight reduction     or body composition change.   "
111041|NCT01832532|"     This is an open label, controlled study.      The investigators are studying if the FDA approved diabetes medicine liraglutide (Victoza®)     can improve sleep apnea in adults. This study is testing liraglutide in 20 adults without     diabetes that are diagnosed with sleep apnea.The treatment group will be compared to a     control group of 10 adults without diabetes who have sleep apnea but will not use     liraglutide. Both groups will continue receiving standard of care for their sleep apnea as     prescribed by their managing sleep physician throughout their study participation.      Everyone in the study will have two study visits and one overnight sleep study for research.     Subjects who have not had a recent sleep study but otherwise qualify for the study, will have     an additional research sleep study to determine the baseline severity of their sleep apnea.     The study visits include fasting blood samples and breathing tests (pulmonary function test     and hypercapnic challenge). There will be weekly phone visits that include a questionnaire on     sleepiness. The group that takes liraglutide will check their blood sugar two times a day     while on the medicine.   "
111042|NCT01832519|"     Our research is comparing the lungs of babies and young children with CF (cystic fibrosis) to     those without CF. We are looking at the blood flow in the lungs to help doctors better     understand how CF damages lungs and how to prevent this damage in the future. We will use MRI     (Magnetic Resonance Imaging) and special blood tests as ways to understand early changes in     the lungs of babies and young children with CF. We will look at the special blood tests to     see if they can work as signals for the doctors to better understand when changes are     happening in the lungs.      For the babies with CF, we will compare MRI images of the lungs to their CT images (also     sometimes called CAT scans or Computerized Tomography). We hope that this study will help us     reduce the number of X-rays and CT scans children with CF might get in the future. Because     MRI's do not use radiation, this could reduce the amount of radiation exposure that children     with CF would get over their lifetime.   "
111043|NCT01832506|"     This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of     MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or     to which no effective standard therapy is applicable.   "
111044|NCT01832493|"     The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a     multicenter, prospective, non-randomized acute feasibility study that is being conducted to     determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the     optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes     in patients indicated for cardiac resynchronization therapy.   "
111045|NCT01832480|"     The overall goal of this project is to determine the influence of patient treatment and host     factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women   "
111046|NCT01832467|"     To determine the objective overall response of re-treatment with cetuximab-based chemotherapy     in patients upon disease progression while under observation, who had previously responded to     first-line or second-line treatment with cetuximab-based chemotherapy for metastatic     colorectal cancer (mCRC), but had stopped treatment for reasons other than disease     progression.   "
111047|NCT01832454|"     This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow     derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36     months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome     measures are improvement in walking ability and kinetic gait pattern.   "
111048|NCT01832441|"     This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow     Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36     months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or     reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any reduction in     requirement of Insulin dosage and Improvement in HbA1C Level.   "
111049|NCT01832428|"     This study is single, centre trial to study the safety and efficacy of Bone marrow derived     autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients ,     the primary outcome measure will be the improvement in muscle power of Body and face   "
111050|NCT01832415|"     The French cooperative group GINECO proposes to implement an observational study to describe     a real situation, in daily practice tolerance and methods of administration of bevacizumab     (Avastin ®)   "
111397|NCT01827839|"     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster     (HZ). The data collected will be compared with the data from subjects without HZ in other     HZ/su trials.   "
111051|NCT01832402|"     The goal of this clinical research study is to learn if fentanyl nasal spray can help to     control shortness of breath in patients who have been treated or are being treated for     cancer.      Fentanyl is commonly used for treatment of cancer pain. It may help patients with their     shortness of breath as well.      In this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks like     the study drug but is not designed to treat any disease or illness. It is designed to be     compared with a study drug to learn if the study drug has any real effect.   "
111052|NCT01832389|"     The objective of this study is to determine whether a goal-directed therapy can reduce the     incidence of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.   "
111053|NCT01832376|"     Study population: Subjects with long standing symptoms from calcific tendonitis,     non-responsive to other forms of conservative treatment      Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by     ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical     examination, imaging of the shoulder by x-ray and sonography and by the self-report section     of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1     and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score     only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient     treatment effect will be offered physiotherapy, re-lavage or surgical treatment by     acromioplasty.      Purpose of the study: The investigators want to find out        -  if shoulder function, measured by a shoulder score, will increase during follow-up        -  how much of the calcific material can be aspirated (in ml)        -  to which extend the calcific deposit disappears on x-rays and sonographic images        -  how many patients will need surgical treatment   "
111054|NCT01832363|"     The purpose of this study is to determine if the bronchial thermoplasty treatment can be     guided through hyperpolarized xenon lung MRI.   "
111055|NCT01832350|"     The primary objective of this study is to test the hypothesis that Nuedexta (20/10)     administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity     (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients     with Alzheimer's Disease (AD). The primary objective will be evaluated using a study endpoint     at 1, 13, 26 weeks after initiation of treatment. The secondary objective of this study is to     evaluate the benefit of treatment with Nuedexta (20/10) on cognition and functionality as     demonstrated in the Rey Auditory Verbal Learning Test (RAVLT), Trail making A and B, Wechsler     Memory Scale (WMS) logical memory and delayed recall, Controlled Oral Word Association     (COWA), Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI), Alzheimer's Disease     Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the 11-item Alzheimer's     Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).   "
111057|NCT01832324|"     The Study examines the molecular basis of food allergy. It explores the interaction between T     cells, InKT cells and cytokines in the development of food allergy. The study also explores     these factors in development of tolerance outgrowing food allergy. It will also explore the     genetic factors that lead to the development of food allergy.      The study examines all type of food allergy including IgE mediated reactions, Eosinophilic     Esophagitis and Food Protein Induced Enterocolitis   "
111058|NCT01832311|"     The purpose of this study is to compare the levels of several immunoregulatory factors in     serums and aqueous humor of type II diabetes cataract patients with those in senile     non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in     diabetic eye may contribute to an increased frequency of intraoperative and postoperative     intraocular lens surgery complications.   "
111059|NCT01832298|"     RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to     chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both     in vitro and in vivo by inhibiting topoisomerase I. Also exerted comparable effects on     topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency     and pharmacologic profiles, compared with the clinically available CPT analogues.      PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of     Simmitecan.   "
111060|NCT01832285|"     The purpose of this study is to determine effect of Fluvoxamine augmentation on cognitive     function , aggressive behavior , clinical symptoms and mRNA (messenger ribonucleic acid) and     protein expression in human peripheral mononuclear blood cells (PMC) in medicated     schizophrenia patients   "
111061|NCT01832272|"     This study is aimed to determine the efficacy and the safety of the tourniquet reinflation     after early tourniquet release in total knee arthroplasty, compared to the method of early     deflation without reinflation. The investigators hypothesized that the reinflation after     early release of the tourniquet would be effective in terms of improved visualization of the     surgical field and decreased operation time and blood loss, whereas it would increase     tourniquet-related complication due to longer tourniquet-use time.   "
111062|NCT01832259|"     The area around a tumor (pre-metastatic niche) may be an area to which cancer cells are     attracted. The study doctor will take blood and tumor samples to look for certain features     linked with response to treatment so that they can predict which future patients may benefit     from this therapy. The purpose of this study is to see if the drug pazopanib can be used to     reduce the amount of pre-metastatic niche in the patient's lymph nodes (a common site for     prostate cancer to spread). Down the line, this may help to prevent prostate cancer from     coming back after surgery.   "
111063|NCT01832246|"     The accurate prediction of depth of tumor invasion in early gastric cancer is essential for     the proper selection of candidates for endoscopic resection. Conventional endoscopy and     endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early     gastric cancer. However, there has been no prospective comparative study on the accuracy     between the 2 methods. Therefore, the investigators prospectively compare the accuracy     between the 2 methods regarding prediction of depth of invasion.   "
115513|NCT01773876|"     Invasive Candida infections are burdened with a high mortality rate and is very common in     intensive care units. This study aims to evaluate the efficacy of empirical treatment with     micafungin in adult patients with suspected invasive candidiasis.   "
111064|NCT01832233|"     People with hypertension are at a higher risk for cardiovascular disease and death so it is     important to lower blood pressure to normal levels as quickly as possible. Previous research     has established that renal nerve denervation successfully lowers blood pressure measured in     the arm in the physician's office. This study is being conducted so that the investigators     can determine whether renal nerve denervation also helps to lower blood pressure over 24     hours, as well as central aortic blood pressure, which is pressure exerted by the aorta     closer to the heart and may be a better predictor of cardiovascular problems. The     investigators also want to know whether these beneficial effects on blood pressure can last     up to 2 years, whether renal denervation reduces the number of medications patients need to     take, and whether it reduces glucose and insulin levels in the blood since hypertension is     also related to obesity and diabetes.   "
111065|NCT01832220|"     This project is designed to examine the interaction between the microflora in the lower     airway and the concentration of a serum protein called alpha-1 antitrypsin. The hypothesis is     that alpha-1 antitrypsin impacts the diversity and content of the lower airway microflora,     resulting in a less inflammatory airway.      The Specific Aims are:        1. To compare the lower respiratory tract microbiome and virome population diversity and          content in age and GOLD stage matched PiZZ individuals not receiving augmentation          therapy, PiZZ individuals on augmentation therapy, PiMZ individuals not receiving          augmentation therapy, and PiMM individuals with chronic obstructive pulmonary disease          (COPD).        2. Determine correlations between bronchoalveolar lavage (BAL) and peripheral blood gene          expression patterns and patterns in lung microbial and viral populations across all          cohorts.        3. Correlate the presence or absence of computed tomography (CT) bronchiectasis and          bronchiolectasis with patterns in the microbiome population diversity and content.        4. To identify and define novel molecular phenotypes of Alpha-1 Antitrypsin Deficiency          (AATD) based on computational integration of clinical, transcriptomic, and microbiome          data.   "
111066|NCT01832207|"     Background The purpose of the present controlled clinical trial was to assess the effect of a     single 60 min application of transcutaneous electrical nervous stimulation (TENS) at sensory     stimulation threshold (STS), compared to the application of motor stimulation threshold (MTS)     as well as to untreatment, on the surface electromyographic (sEMG) and kinesiographic     activity of patients with temporomandibular disorder (TMD). Methods Sixty female subjects,     selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in     remission were assigned to MTS, STS or untreatment. Pre- and post-treatment differences in     the sEMG activity of temporalis anterior (TA), masseter (MM), digastric (DA) and     sternocleidomastoid muscles (SCM), as well in the interocclusal distance (ID), within group     were tested using the Wilcoxon test, while differences among groups were assessed by     Kruskal-Wallis test; the level of significance was set at p ≤ 0.01.   "
119664|NCT01719601|"     The purpose of this study is to evaluate the safety and effectiveness of immediate release     tapentadol hydrochloride for the relief of moderate to severe acute non-cancer pain among     Filipino patients.   "
111067|NCT01832194|"     There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal     pain that we found published. We propose a pilot study to use Botox to block the testicular     nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical     therapy. The men must have had temporary relief from a testicular cord block using marcaine.     Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men     would be asked to fill in visual analog scales for pain, a quality of life assessment, a     depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be     subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.   "
111068|NCT01832181|"     The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is     increasing evidence that in-utero exposure to maternal diabetes is associated with an     increased risk of obesity and type 2 diabetes in children and adults. There is an urgent need     to reduce these increasing rates of obesity and diabetes in subsequent generations.      The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded     multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample     size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin     to a standard regimen of insulin in women with diabetes, on perinatal morbidity and     mortality.      The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment     with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in     adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2     years of age.   "
111069|NCT01832168|"     The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic     membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic     prostatectomies.   "
111070|NCT01832155|"     The study hypothesized that it is feasible and safe to use Hatha yoga in older women with     knee osteoarthritis (OA), and practicing Hatha yoga regularly will help reduce pain and     stiffness, enhance physical function, and improve quality of sleep and quality of life in     older women with knee OA.   "
111071|NCT01832129|"     In this study, biomarker response after supplementation with oral and intramuscular vitamin     B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be     used to control for non compliance as a possible confounder in oral treatment. Additionally     subjective acceptance in terms of presumed preferences will be compared with oral vs.     intramuscular supplementation of vitamin B12 in the view of the patient.   "
111072|NCT01832116|"     The purpose of this multicenter imaging sub study is to evaluate the biodistribution and     organ pharmacokinetics of 89Zr-MMOT0530A in patients with unresectable pancreatic or     platinum-resistant ovarian cancer. MMOT0530A is a monoclonal antibody that targets an antigen     overexpressed in pancreatic and ovarian cancer. Subsequent to imaging with 89Zr-MMOT0530A,     patients will be treated with DMOT4039A in the DMO4993g protocol (clinicaltrials.gov     identifier NCT01469793) after this study. DMOT4039A is an antibody-drug conjugate composed of     the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). By     imaging patients with the monoclonal antibody MMOT0530A before treatment, the correlation     between tumor uptake of 89Zr-MMOT0530A and response to DMOT4039A therapy will be assessed.   "
111073|NCT01832103|"     The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of     MK-7145 2 mg immediate release (IR) following single-dose administration in male participants     with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic     effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants     with moderate renal insufficiency.   "
111076|NCT01832051|"     Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor     lesions in breast cancer patients is essential for diagnostic and therapeutic management of     metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be     difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical     dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack     of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional     information, have so far not been able to replace the biopsy. To solve this problem,     non-invasive whole body visualization and quantification of HER2 expression by means of the     HER2-PET may be a valuable tool.      In this prospective multicenter imaging study, eligible patients will receive one HER2-PET     and CTC analysis in addition to standard work up for metastatic disease. Subsequent     administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three     questionnaires, one before HER2-PET and two after HER2-PET.   "
111077|NCT01832038|"     The purpose of this trial is to evaluate the safety and tolerability of long-term     administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with     Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]   "
111078|NCT01832025|"     Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery     procedure where bone is added to the upper jaw near the molars. The goal of the surgery is to     add enough bone material onto the upper jaw to support the placement of a dental implant. The     augmentation and the dental implant placement will be done at the same time to avoid the need     for two surgeries. This is standard of care.      The purpose of this study is to compare any problems and patient comfort levels following     surgery. Subjects will be randomly placed into one of two groups: the internal lift group or     the external lift group. Both types of surgery are routinely done at our clinic. Usually the     type of procedure (internal or external) is based on the dentist's preference. Investigators     are doing this study to compare them to each other to see if one is more comfortable for the     subject than the other or if they are equal. It is predicted that the two techniques may     differ when it comes to complications during the procedure, patient discomfort following the     procedure and patient complications in the weeks and months after the procedure. This last     comparison has not yet been studied, and surgeons often choose the technique that they prefer     from their own experiences. With this research study researchers hope to gain valuable     information that will help surgeons' decisions in the future.        -  Investigators hypothesize that external sinus augmentation with simultaneous implant          placement (external technique) will have a higher rate of Schneiderian membrane          perforation than the internal sinus augmentation with simultaneous implant placement          (internal technique).        -  Investigators hypothesize that the internal technique is associated with more discomfort          for the subject compared with the external technique.        -  Investigators hypothesize that the external technique will result in more severe          pain/bleeding/swelling than the internal technique.        -  Investigators hypothesize that the internal technique has a higher incidence of          complications that occur between three weeks and three months postoperatively compared          with the external technique.        -  Investigators hypothesize that the external technique has a higher amount of analgesics          taken postoperatively compared with the internal technique   "
111079|NCT01832012|"     175 second year medical students were assessed on their BLS CPR skill retention after an     approximate one year after taking the initial certification class, and the investigators     assessed which type of refresher course would be most effective in improving the students'     CPR skills. Group 2 had no refresher, Group 3 had a multimedia refresher, and Group 4 had the     same multimedia refresher plus hands on practice on a Laerdal BLS manikin. The investigators     hypothesized that Group 4 would perform CPR skills with the highest competency compared to     the other two groups.   "
111080|NCT01831999|"     Building on the recent advances in telephone supported care, clinical monitoring, and     outreach work, the specific aims of the study are to:        1. Develop RecoveryTrack™- ExtendedCare (RT-E), a modified/new version of RecoveryTrack™.          The investigators will adapt and finalize the original Web-based RT system, manual, and          training to accommodate use by counselors for clients who are no longer attending          Outpatient (OP) treatment.        2. Conduct a pilot study to determine the preliminary efficacy of RT-E compared to          treatment as usual (TAU) for clients entering Intensive Outpatient (IOP) substance abuse          treatment (SAT). In this randomized clinical trial, it is hypothesized that RT-E will          positively impact treatment attendance and substance use outcomes. In exploratory          analyses, the investigators will also evaluate the comparative impact of RT-E versus TAU          on HIV related client behaviors.        3. Evaluate feasibility and counselor and client acceptability of RT-E.        4. Conduct preliminary cost and cost effectiveness analyses comparing RT-E to TAU.      Hypothesis 1: RT-E clients will attend more days of OP treatment than TAU clients. The     investigators will compare the two groups on monthly treatment attendance for months 1     through 9. We expect a main effect of group with RT-E clients displaying more attendance than     TAU clients.      Hypothesis 2: RT-E clients will have higher rates of abstinence than TAU clients. The     investigators will compare abstinence rates at months 3, 6, and 9. Abstinence is a binary     variable based on both biological test results and self-reported substance use from the     Addiction Severity Index, Version 6 (ASI6). We expect a main effect of group with RT-E     clients displaying higher rates of abstinence than TAU clients.      Secondary Analyses:      HIV Risk Scores: The investigators will compare the two groups' Risk Assessment Battery (RAB)     HIV risk scores (i.e., total, sex, drug) at month 9.      Use of HIV specialist services: Client attendance charts will be reviewed to compare the two     groups on the number of times clients met with a program HIV Specialist at month 9.      Multidimensional Outcomes: The investigators will compare RT-E and TAU clients on     multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.   "
111081|NCT01831986|"     Schizophrenia (SZ) and schizoaffective (SA) disorders are comprised of several debilitating     symptoms. It was suggested that compounds with neuroprotective effects might be useful in the     management of SZ/SA symptoms. Our previous clinical trials indicated significant beneficial     effects for augmentations with two different neuroprotective agents: Pregnenolone and     L-Theanine. Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the     central nervous system. Our recent 8-week, randomized, double-blind trial among patients with     chronic SZ/SA disorders, in which PREG versus placebo and DHEA was added to antipsychotics,     yielded encouraging results: PREG augmentation demonstrated significant amelioration of     positive symptoms, EPS, as well as an improvement in attention, and working memory     performance of SZ/SA disorder patients (Ritsner et al 2010). L-Theanine is a unique amino     acid present almost exclusively in the tea plant. It possesses neuroprotective,     mood-enhancing, and relaxation activities. L-theanine augmentation to antipsychotic therapy     can ameliorate positive, activation, and anxiety symptoms in SZ/SA disorder patients (grant #     06TGF-911, (Ritsner et al 2010). This proposed study would extend our prior research with     Pregnenolone and L-theanine by combining both agents versus placebo. We hypothesized that     addition of both these compounds to ongoing antipsychotics would significantly improve the     clinical status of SZ/SA patients.      Methods: In an 8-week, randomized, double-blind placebo-controlled trial a combination of     PREG (50 mg/day) with L-theanine (400 mg/day) versus placebo will be added to the stable     ongoing antipsychotic treatment of 200 patients with schizophrenia or schizoaffective     disorders. This trial will be conducted at five sites in Israel. Participants will be     assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research     instruments will be used for the assessment of psychopathology, side effects, general     functioning and quality of life   "
111082|NCT01831973|"     INVESTIGATIONAL PRODUCT:      TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl.      PHASE OF DEVELOPMENT:      Phase II      No. OF PATIENTS:      Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients)      STUDY OBJECTIVES:      Primary      • To evaluate non-progression disease (non-PD) rate at the end of cycle 6      Secondary        -  To evaluate progression free survival (PFS)        -  To evaluate overall survival (OS)        -  To evaluate the duration of non-PD        -  To evaluate objective response rate (ORR; where ORR= CR+PR) and duration        -  To evaluate the safety profile of TLC388        -  To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6      STUDY DESIGN:      This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388 monotherapy     in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).   "
111083|NCT01831960|"     This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression     potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve     hours for two weeks, in subjects with acne vulgaris ages 12 years or older.   "
111084|NCT01831947|"     This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody     on the acuteness of vision. Patients included are suffering from choroidal     neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).      Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3     months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second     group is treated on demand.      The primary end point of the study is the change of best-corrected visual acuity after 12     month.      Secondary end points include the impact of Ranibizumab on morphological changes of the     retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12     months, changes in quality of life and the number of injections required during the first 12     months of treatment.   "
111085|NCT01831934|"     This pilot clinical study evaluated the safety and metabolic responses to a licensed     inactivated seasonal influenza vaccine (TIV) in mitochondrial encephalopathy, lactic     acidosis, and stroke-like episodes syndrome (MELAS) volunteers and controls.   "
111086|NCT01831921|"     The investigators plan to test two different strategies for weight loss and diabetes     prevention in the Latino community in and around Forsyth County, NC. The study is designed to     test the hypothesis that a lifestyle weight-loss program implemented within the Latino     community will have a more beneficial and clinically meaningful impact on HbA1c, insulin     metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care     condition. This lifestyle intervention will include group-based sessions promoting healthy     eating, increased physical activity and weight loss. These sessions will be delivered by lay     community members, known as Latino Health Advisors (LHAs). The enhanced usual care group will     consist of individual counseling with are registered dietitian and uses existing community     resources to assist participants in making healthier lifestyle choices.   "
111087|NCT01831908|"     Persons voluntarily attending the Community Center of the Atahualpa Project during one     calendar year will be evaluated by trained personnel to check their cardiovascular health     status. A chart with information of healthy behaviors as well as the numbers of the person's     blood pressure, fasting glucose, and total cholesterol levels will be given. Persons who sign     the informed consent will be visited at their homes after 3 months and than every year up to     five years. The idea is to check whether the person followed our advises and if that     compliance iis associated with improvement in the cardiovascular status or with a decreased     incidence of stroke and ischemic heart disease, when compared with persons who did not attend     the community center or those who did not follow our advices.   "
111088|NCT01831895|"     To evaluate the safety and performance of the MobiusHD system in subjects with resistant     hypertension.   "
111089|NCT01831882|"     The primary objective of this study is to investigate the biological components of major     depression. The investigators are particularity interested in genetic variation and how it     contributes to cortisol (because cortisol is higher in severe depression than mild depression     or healthy controls) and how it contributes to clinical symptoms, especially suicidal     ideation/behavior and psychosis.   "
111090|NCT01831869|"     Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general     population, especially in women older than 50 years old. It is controversial whether SCH can     lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine     reverses these risks. The present study was designed to evaluate the effect of L-thyroxine     treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory     factors and adipocytokines.   "
111091|NCT01831856|"     The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal     cardiac rhythm after direct electric cardioversion in patients with persistent atrial     fibrillation and cardiac failure.   "
111092|NCT01831843|"     To evaluate differences in intraoperative body temperature between heated huimid breathing     circuit and conventional breathing circuit   "
111093|NCT01831830|"     The primary objective of this study is to evaluate the preliminary effectiveness and     acceptability of an innovative in-home nonpharmacological intervention, the Veterans' In-home     Program (VIP), for Veterans with mild to moderate traumatic brain injury (TBI) and their     families. VIP is designed to promote community reintegration, improve quality of life, and     support functioning by realigning environmental demands to match the Veteran's abilities.   "
111094|NCT01831817|"     The purpose of this exploratory study is to compare the treatment effect on dentinal     hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile     sensitivity. This proof of concept study will compare the test dentifrice with three other     treatment groups.   "
111095|NCT01831804|"     This is a randomized, placebo-controlled, single-blind (subjects and investigators will be     blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part     B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to     evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin)     and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first     single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by     subjects at home. Part B will include approximately 3 cohorts in which the concentration of     drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in     Part B.   "
111096|NCT01831791|"     This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of     0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia     types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a     Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who     completes the full course of study treatment and the final study visit (Week 52; Visit 7)     will be considered as study completion.   "
111121|NCT01831466|"     The study is beng done to test if tofacitinib ointment is safe and effective for people with     plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied     once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment     used for 12 weeks will be compared to the safety and effectiveness of placebo ointment     (vehicle) used for 12 weeks.   "
111122|NCT01831453|"     The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral     aphthous ulcers   "
111097|NCT01831778|"     The Breast Cancer Surveillance Consortium (BCSC) database contains data from 1994-2009 on     breast cancer screening, quality, and outcomes, and its main goal is to advance breast cancer     research. This project is funded to maintain the BCSC database and share the data with     investigators. Our objectives are to:        -  Maintain the BCSC pooled database using secure methods that protect the confidentiality          of women, radiologists, facilities, and BCSC registries;        -  Encourage and facilitate sharing of BCSC research resources, and continue developing and          implementing our communications plan to expand resource dissemination;        -  Provide statistical and scientific expertise to researchers, distribute customized          limited datasets, and analyze BCSC data;        -  Develop and support a new web-based dynamic query tool and other electronic interfaces          to efficiently share aggregated BCSC data with the public.   "
111098|NCT01831765|"     This trial is conducted in Europe and the United States of America (USA). The aim of the     trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared     to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes.     This trial consists of two periods: a 26 week treatment period followed by a 26 week     additional treatment period.   "
111099|NCT01831752|"     This study is for adults and adolescents with type 1 diabetes. The purpose of this study is     to learn more about an investigational system to measure blood glucose. This system does not     require blood to be drawn from the body, and it does not require a glucose sensor to be worn     under the skin (subcutaneously). This device instead estimates blood glucose levels by     shining infrared light on the skin and then using sophisticated statistical analysis on how     the light bounces back or gets absorbed (spectral data). The researchers in this study will     compare the accuracy of the new device to glucose measurement devices that are already     approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring     (CGM) sensors. Information learned from this study will be used in the development of tools     for managing diabetes.   "
111100|NCT01831739|"     This project is designed to address the following hypothesis:      Distinct patterns in lung microbiome are characteristic of sarcoidosis phenotypes and     reflected in changes in systemic inflammatory responses as measured by peripheral changes in     gene transcription.      The Specific Aims are:        1. To identify peripheral blood mononuclear cell (PBMC) gene expression patterns that          characterize distinct sarcoidosis phenotypes.        2. To determine whether patterns in the lung microbiome are associated with sarcoidosis          severity and disease phenotypes        3. To correlate mRNA and microRNA expression patterns in sarcoidosis affected organs with          changes in microbiome, clinical parameters and PBMC gene expression patterns        4. To integrate clinical, transcriptomic, and microbiome data to identify novel molecular          phenotypes in sarcoidosis.   "
111101|NCT01831726|"     The purpose of this signal seeking study was to determine whether treatment with dovitinib     (TKI258) demonstrated sufficient efficacy in select pathway-activated solid tumors and/or     hematologic malignancies to warrant further study.   "
115247|NCT01777347|"     The purpose of this study is to determine whether nebulized hypertonic saline solution     reduces the admission rate 48 hours after initial treatment in the emergency department, when     compared to normal saline solution (control).   "
111102|NCT01831713|"     Historically, transthoracic Doppler echocardiography has been unable to provide interpretable     data of blood flow within the lung parenchyma because of air attenuation of Doppler signals.     Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD)     System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals.     The ability to non-invasively collect information regarding the pulmonary aspect of the     cardio-pulmonary system may provide valuable information and new insights into the structural     and functional characteristics of the lung parenchyma and vasculature in health and disease     states.   "
111103|NCT01831700|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fasting condition in     normal, healthy, adult, human subjects.   "
111104|NCT01831687|"     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,     two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to     assess the bioequivalence between Test Product and the corresponding Reference Product under     fed condition in healthy, adult human subjects.   "
111105|NCT01831674|"     The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose,     crossover, oral bioequivalence study in normal, healthy adult human subjects under fed     condition.   "
111106|NCT01831661|"     The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose,     crossover, oral bioequivalence study in normal, healthy adult human subjects under fasting     condition.   "
111107|NCT01831648|"     Various assays can be used for IGF-I measurement in French laboratories. Unfortunately, each     assay gives a very different result for the same sample. As IGF-I also varies with age, it is     necessary to establish a broad population reference values of IGF1 concentration for each of     the IGF1 assays used in clinical practice, taking into account individual variation factors     such as age, nutritional status and possible treatments.      The objective of this study is to establish normative data based on a large random selection     from the general population, including representation from all age groups (around 100     subjects for each decade age range). This will be performed for all the available assay kits.     Subjects with medical conditions and medications that may affect the outcome will be     excluded. Normative data will include the range (2.5 to 97.5 percentiles) in mass units and     results will be reported as mass units but also as SD scores in order to be able, in a given     patient, to compare its IGF-I concentration along time, even if using different assays.   "
111123|NCT01831440|"     The purpose of this study is to determine the level of residual symptoms and psychosocial     factors affecting recovery of psychosocial functions in MDD patients who reach remission, and     investigate the recovery process of psychosocial functions.      The investigators suppose that even the patient is well-treated by drug,there are still many     residual symptoms,and they also exist different degree of damage in the structure and     functions of brain. CBT could help them obtain better recovery,especially in psychosocial     functions.   "
111124|NCT01831427|"     This is a staggered, placebo-controlled, single and multiple ascending dose (SAD/MAD) study     evaluating the safety, tolerability and pharmacokinetics of GS-5745 in participants with     moderately to severely active ulcerative colitis. This study will provide valuable data that     can help establish the safety, pharmacokinetics and efficacy of GS-5745 in participants with     ulcerative colitis.   "
111108|NCT01831635|"     There is a paucity of data on the aetiology of myeloproliferative neoplasms (MPNs). The     investigators conducted a systematic review of the literature which identified several cohort     and case-control studies that have investigated a wide range of potential medical,     environmental and occupational risk factors. However, these studies have been limited by a     wide variation in case definition and small sample sizes limiting the potential to detect     modest risk differences between cases and controls. The research group propose an exploratory     case-control study of 100 patients with classic MPNs and 200 controls to determine the     optimal methods for roll out of this study to a multi-centred UK-based case-control study     that will investigate the aetiology of MPN subtypes. The objectives of the study are to     evaluate recruitment procedures, response rates, the development of a telephone administered     questionnaire, compare occupational exposure assessment using OccIDEAS, a novel web based     program, with a job-exposure matrix (FINJEM), evaluate the feasibility of collection of DNA     from saliva compared to blood samples, identify potential aetiologic factors associated with     MPNs and explore assessment of quality of life. The findings of this exploratory study will     form the basis of a protocol for a large United Kingdom (UK)-wide case-control study of MPNs.   "
111109|NCT01831622|"     The goal of this trial is to investigate the cognitive- and brain-mechanisms underlying     decision making (DM) and learning in young adults with Attention-Deficit/Hyperactivity     Disorder (ADHD) as well as the modulation of task-related and task-independent brain     activation by methylphenidate. The study aims at using a double-blinded, placebo controlled,     cross-over, withdrawal design to study the effects of ADHD and methylphenidate in both a     behavioural study investigating cognitive effects on decision making and instrumental     learning, and a functional MRI (fMRI) study investigating the effects on brain mechanisms     during decision making alone. A secondary objective of the trial is to measure the effect of     adult ADHD and methylphenidate on cerebral perfusion. This will be done through applying a     novel arterial spin labelling MRI-technique on the participants in the fMRI arm of the study.   "
111110|NCT01831609|"     To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary     cultures from metastatic cancer patients. The specimens will be analyzed using     DNA/RNA/proteomic approaches.   "
111111|NCT01831596|"     The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP     Device.   "
111112|NCT01831583|"     The goal of this study is to collect raw waveform data for two separate noninvasive methods,     both of which may be useful for the assessment of upper airway obstruction.   "
111156|NCT01830998|"     The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals     with type 2 diabetes.There are no established specific treatment measures to prevent or     ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical     dementia in diabete.   "
141108|NCT01437527|"     The purpose of the study is to test a new procedure of body image therapy in anorexia     nervosa, using the anamorphic micro software.   "
111113|NCT01831570|"     Introduction Osteoarthritis is a chronic disease characterized by a progressive degradation     of articular cartilage. Hand OA involves symptomatically more than 1 million of subjects in     France (i.e., painful or with functional impairment). To date, the treatment of OA is only     symptomatic and no drugs are able to stop the degradative process of cartilage.      50% of patients with hand OA exhibit a functional impairment responsible for a severe     handicap, which is almost similar to rheumatoid arthritis. While the risk factors of hand OA     are well identified (i.e., familial history, female sex, menopause, obesity), clinical     outcome in large cohort is poorly known. In addition, the investigators miss predictive     clinical, biological or imaging factors of severe clinical (i.e. pain, functional impairment     or aesthetic damage) or structural evolution (i.e., aggravation of radiographic scores).      Primary objective To investigate in hand OA patients predictive clinical, biological, genetic     and imaging factors of clinical aggravation after 6 years of follow-up.      Secondary objectives To investigate in hand OA patients predictive clinical, biological,     genetic and imaging factors of clinical aggravation after 3 years of follow-up.      To investigate in hand OA patients predictive clinical, biological, genetic and imaging     factors of clinical aggravation after 3 years of follow-up.      To investigate whether variations of clinical evaluation of hand hand OA and radiographic     structural changes are associated or correlated between inclusion and 3 years of follow-up or     between inclusion and 6 years follow-up To investigate whether clinical status and     radiographic alterations are correlated at inclusion To determine whether hand OA is     associated with OA at other sites or with other hand diseases (carpal tunnel syndrome,     tendinitis) To evaluate frequency of erosive hand OA among the whole hand OA cohort at     inclusion, at 3 and 6 years of follow-up To identify clinical, biological, genetic and     imaging factors associated with erosive hand OA (versus non erosive hand OA) at inclusion or     during the follow up (3 and 6 years) To investigate predictive clinical, biological, genetic     and imaging factors of clinical or radiographic aggravation after 3 or 6 years of follow-up     in the erosive hand OA subgroup      Methods :      the investigators plan to include 500 patients in the cohort (5/week) 7 visits (one per year)     are planned: M0, M12, M24, M36, M48, M60 and M72. A clinical evaluation of hand OA will be     performed at each visit. At visit M0, M36 and M72, hand radiographs and radiographs of other     OA localisation (if symptomatic) will be performed.      A blood sample will be taken at inclusion for biomarker studies and genetic investigations.      A blood sample will be taken at M36 and M72 to build a prospective serum collection.      Duration of the study: 8.5 years with 2.5 years of inclusion period Duration of the study for     one patient: 6 years Recruitment at the Rheumatology Department of Saint-Antoine Hospital     with a multicentric international steering committee      Potential outcomes :        -  Identification of clinical, radiological and biological tools useful to predict clinical          and structural outcomes        -  Description of the history course of hand OA and predictive factors of severe evolution          (i.e. erosive form of hand OA) To integrate in daily practice, clinical and radiological          tools allowing a standardized follow up of hand OA patients.   "
111114|NCT01831557|"     The objective of this study is to explore the genetic basis of the influence of dairy product     intake on body measures in children. The investigators assume that the effect of dairy     products intake on children body measures is affected by genetic polymorphisms.   "
111115|NCT01831544|"     This multi-center, prospective, non-randomized, single-arm trial will investigate the safety     and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over     24 months in subjects with advanced heart failure   "
111116|NCT01831531|"     This trial aims to study the safety, the local control, and the overall survival of S-1     combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients     will be recruited into this trial.   "
111117|NCT01831518|"     Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart     in order to improve the coordination of the contraction in patients with heart failure.     Current selection criteria incorporate the severity of the symptoms, the mechanical function     of the heart and the time it takes the electrical stimulation to spread over the left     ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these     criteria only seem to select approximately 70% of the patients who might respond to this     invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical     activation of the heart in more detail than the standard ECG. This study aims to determine     whether this new technology may aid current selection criteria in predicting response to CRT.   "
111118|NCT01831505|"     Many cancer patients are prescribed drugs to which their cancer is already resistant - and     thus suffer toxicity with no potential for benefit. Previous attempts to assess     chemoresistance or sensitivity in vitro have failed. This is a feasibility study in human     patients with newly diagnosed or recurrent lymphoma to determine how human cancerous lymph     nodes in situ respond to standard of care therapeutics precisely microinjected with the     CIVO(tm) microdosing system.   "
111119|NCT01831492|"     Purpose:      This study investigates the effects of dietary zeolite + dolomite on performance,     exercise-induced acidosis, oxidative stress, inflammation and intestinal barrier dysfunction     in trained people.      Hypotheses (H1):      Zeolite + dolomite increase performance in an ergometer step test Zeolite + dolomite reduce     exercise-induced acidosis Zeolite + dolomite reduce oxidative stress Zeolite + dolomite     reduce inflammation Zeolite + dolomite improve intestinal barrier dysfunction   "
111125|NCT01831414|"     Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless     environment and which is often used in patients with spinal cord injury. In normal subjects,     water immersion generates a reduction in lung volumes. The effects of water immersion on the     respiratory function of spinal cord injury patient (who are liable to present a respiratory     failure secondary to paralysis) are not well known. They could be deleterious (by majoring     respiratory failure)or beneficial (by mimicking the effect of a corset and improving     respiratory function). Therefore, we are planning to study the effect of different water     immersion levels on the respiratory function of spinal cord injury patients.   "
111126|NCT01831401|"     Total Hip Arthroplasty (THA) is one of the most commonly performed orthopaedic operations     worldwide. The main aim is overall improvement in levels of patient pain and mobility. Such     surgery involves implantation of both an acetabular and femoral component. With the patient     in the lateral decubitus position, the Orthopaedic Surgeon assumes that the pelvis is in a     neutral position with respect to all three body planes at the time of acetabular component     implantation.      With regard to THA, the current orthopaedic literature demonstrates a clear relationship     between acetabular component positioning, polyethylene wear and risk of dislocation. Problems     with edge loading, stripe wear and squeaking are also associated with higher acetabular     inclination angles, particularly in hard-on-hard bearing implants.      The important parameters of acetabular component positioning are depth, height, version and     inclination.      Control of acetabular component inclination, particularly in the lateral decubitus position,     is difficult and remains a challenge for the Orthopaedic Surgeon.      Accurate implantation of the acetabular component within the 'safe zone' of radiological     inclination is dependent on:        -  Operative version        -  Operative inclination        -  Pelvic position (Primarily, but not exclusively, abduction / adduction.)      This study aims to investigate the effect of patient pelvic positioning and method of     acetabular component insertion on acetabular component inclination during Total Hip     Arthroplasty (THA).   "
111157|NCT01830985|"     This study is designed to evaluate the long-term safety and tolerability of VX-509 in     subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll     subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).   "
112256|NCT01816594|"     This randomized, parallel cohort, two stage, double-blind, placebo-controlled study will     evaluate the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in     HER2-positive primary breast cancer prior to definitive surgery (neo-adjuvant setting).   "
111127|NCT01831388|"     The purpose of this study is to test whether a breath training exercise program may be used     to make patients with chronic lung conditions feel less short of breath, whether such a     program is well received by patients and whether a future larger study is worthwhile.      The breath training exercise program uses some breathing techniques derived from Yoga     practices. They were shown to help patients experiencing shortness of breath feel less short     of breath in other settings. Whether the training is beneficial to patients with chronic lung     conditions, especially those with a history of cancer affecting their lungs, is not clear.     This study would help us answer that question.   "
111128|NCT01831375|"     This research represents a pioneering effort to design a brief, cost effective and readily     transportable program that will enable disadvantaged elders to become more effective     participants in their health care.      The intervention is expected to result in trained elders becoming more knowledgeable health     care partners. Trained patients will be prepared for appointments and will engage their     primary care physicians in active dialogue regarding cancer prevention and screening.      Based on self-advocacy, these patients are expected to receive better preventive care and     report greater satisfaction with care. Program participation can subsequently contribute to     general health improvements and minimize health disparities.   "
111129|NCT01831362|"     This study addresses NCCAM's request for research that investigates the neuropsychological     mechanisms underlying mind-body therapies, and for precise criteria and better delineation of     meditation practices.      The purpose of this study is to assess the clinical efficacy and mechanism of action of 2     component practices of mindfulness meditation, i.e. focused awareness (FA) and open     monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based     Cognitive Therapy (MBCT).   "
111130|NCT01831336|"     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring     coronary revascularization with Drug Eluting Stents (DES).   "
111131|NCT01831323|"     To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of     diverticular disease, comparing it with the effects exerted by supplementation with fibers,     by rifaximin and by mesalazine, and assessing the evolution over time after each specific     treatment   "
111132|NCT01831310|"     Hypercatabolism and immune suppression are frequently seen in patients with malignancy.     Preoperative nutritional state is an important factor in determining surgical and     postoperative complications because the preoperative nutritional status affects the     postoperative nutritional state, immunity and inflammatory response. In these patients,     standard parenteral nutrition may not be sufficient to maintain the immunity and provide     positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with     immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T     lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa.     There is a report which showed that glutamine dipeptide supplemented parenteral nutrition     improved the cellular and humoral immune functions. The investigators aimed to evaluate the     effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral     nutrition on the neutrophil functions and postoperative course of patients with colorectal     cancer.   "
111133|NCT01831297|"     This study´s aim is to explore physiological associations concerning pulse wave velocity,     heart rate and blood pressure in order to make taking the blood pressure more comfortable.   "
111134|NCT01831284|"     The goal of this study is to learn how injection drug use may affect the immune system.   "
111135|NCT01831271|"     The overall objective is to evaluate if treatment with a neck-specific exercise program and     cognitive behavioural approach improves the outcome compared with prescribed, self-mediated     and progressive physical activity in patients with cervical radiculopathy. There is a lack of     evidence of the best treatment for the patient category. Many patients are sick-listed for     long periods of time with different kind of treatment approaches or without any treatment at     all. The present study could fill the identified knowledge gap by strengthening of the     currently weak scientific evidence for treatment of the patient category. The long-term     effects of the study could be to reduce the time for sick leave and improve the rate of     patients returning to work and/ or former activity by optimising treatments. Further on, to     decrease the number of patients who finally have surgery for their neck problems and thus     reducing the mental, physical and social costs.   "
111136|NCT01831258|"     Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the     pressure during wakefulness may improve therapy comfort and potentially adherence without     compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by     Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the     transition from sleep to wake. When the transition from sleep to wake is detected the device     promptly reduces the pressure to help facilitate a return to sleep.      The purpose of this study is to compare adherence and sleep quality outcomes in patients     treated by CPAP with and without SensAwake technology.      It is hypothesised that participants with SensAwake on will have improved adherence and sleep     quality.   "
111137|NCT01831245|"     Register study. Patients who had been operated for right-sided colon tumor or benign adenoids     between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an     ERAS (Enhanced Recovery After Surgery) protocol.      Hypothesis:      Operation of right-sided colon tumor and large benign adenoids, a better selection of     patients for open or laparoscopic surgery can improve short term results.   "
111138|NCT01831232|"     This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating     patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used     in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin     sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more     cancer cells.   "
111158|NCT01830972|"     GNE myopathy or hereditary inclusion body myopathy (HIBM) is a severe progressive metabolic     myopathy caused by a defect in the biosynthetic pathway for sialic acid (SA). The purpose of     the study is to measure long term safety and the effects of Sialic Acid-Extended Release     (SA-ER) tablets and Sialic Acid-Immediate Release (SA-IR) capsules.   "
111139|NCT01831219|"     This is a follow-up study looking at the and long-term results of two methods of preparing     the thigh bone to receive an implant during hip replacement surgery. For one group of     patients in the original study, the surgeon used a cutting tool called a broach and a special     hammer on patients who had standard hip replacement operations. For the other patients, the     surgeon used a surgical robot which was equipped with a cutting tool, like a drill, to     prepare the thigh bone. The purpose of this study is to collect additional information     confirming that the surgical robot is safe and effective when used as recommended. Only     patients who were enrolled in the original clinical trials are eligible for this study.   "
111140|NCT01831206|"     The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment     of infectious keratitis.   "
111141|NCT01831193|"     The purpose of this study is to determine if the oral supplementation with curcumin reduces     proteinuria in patients with chronic kidney disease regardless the ethiology.   "
111142|NCT01831180|"     The purpose of this study is to compare the differences in various chemical and biologic     parameters of scalp and and hair parameters between young and old Caucasian females. The hair     state and scalp blood flow in younger and older age groups with typical hair care practices     will be qualified by measuring various parameters of the hair shaft and scalp with     correlation back to hair and scalp satisfaction as measured in the subject. This is a single     center study with an anticipated 4 month enrollment period. The investigators will compare     various scalp and hair parameters between young and old Caucasian females by obtaining the     following biological and chemical/structural information. Hair growth rate, anagen to telogen     ratio, hair density (determined via phototrichogram and digital imaging), Vascular blood flow     (Laser Doppler Flowmetry), Histamine stimulation and Hair diameter (clipped hairs). In     addition, a detailed questionnaire will be administered to each subject regarding     satisfaction of the subject's hair state, including typical hair care regimens and symptoms     in scalp and/or hair shafts. This information will be correlated to the biologic and     chemical/structural information about hair and scalp health. Approximately 50 healthy,     Caucasian female subjects will be enrolled in this study. Twenty five participants will be     19-25 years-old and 25 participants 60 years or older. There will be two visits, Baseline and     approximately 48 hours after baseline.   "
111143|NCT01831167|"     In two sessions of four days nurses will be exposed to dynamic lighting and normal     (reference) lighting. Through the psychological tests T.O.D.A. (Test or divided attention)     and T.O.S.S.A. (Test of sustained selective attention), then the focus tested. These two     tests run both 5 times. The investigators also ask to fill out: 3 questionnaires, fatigue and     mood, sleep and Questions of Life.   "
111144|NCT01831154|"     The purpose of this study was to investigate the effects of three different glycemic     treatment conditions (tight, conventional, and standard) in the intraoperative period on: 1)     postoperative surgical site infections, and 2) postoperative procalcitonin, and C-reactive     protein levels in patients undergoing open-heart surgery. Secondary aims of the study were to     investigate the effects of the three glycemic treatment conditions on: 1) intraoperative     blood glucose; 2) intraoperative glycemic stability; and 3) intensive care unit length of     stay, in patients undergoing open-heart surgery.   "
111145|NCT01831141|"     Congenital solitary kidney (CSK) is a disorder caused by an abnormal development of one of     the two kidneys. The reported incidence ranges between 1:450-3200. It is debated whether CSK     is a benign condition or not. A variable risk of developing proteinuria (11-27%),     hypertension (0-60%) and chronic kidney damage (3.5-30%) is described. This knowledge derives     mainly from retrospective studies performed in tertiary medical centers which is difficult to     compare for the following reasons: the number of individuals evaluated, the length of     follow-up and the outcome studied.      The aim of this longitudinal study is to assess, in a cohort of children with congenital     solitary kidney, during a 10 year follow-up period: 1) the rates of developing proteinuria,     hypertension and chronic kidney disease and the corresponding potential prognostic factors.     2) the role of new biomarkers of glomerular (Cystatin C) or tubular damage (NGAL, NAG,     B2-microglobulin) in predicting the appearance of chronic kidney damage.   "
111146|NCT01831128|"     The purpose of FACE study is to provide in routine practice complementary long-term data on     the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea     eligible for Adaptative Servo-Ventilation (ASV) treatment (PaceWave, AutoSet CS; ResMed).   "
111147|NCT01831115|"     To improve the diagnostic and prognostic utility of various biomarkers, detailed patient's     history, physical examinations and technical devices in patients presenting with acute     dyspnea.   "
120086|NCT01714076|"     Observational cohort study in children hospitalized for acute bronchiolitis. Patients are     nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of     co-infections in this group.   "
111152|NCT01831050|"     This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted     in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children     previously vaccinated with 3 doses of bOPV. We will examine the impact of supplemental IPV on     stool shedding and humoral immunity, as well as intra-IPV manufacturer comparability, and     safety.   "
111153|NCT01831037|"     This study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB)     experiencing regression of liver cirrhosis after effective antiviral therapy have decreased     risk for hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in     patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to     identify the magnitude of the decreased risk for HCC in patients experiencing regression of     fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought,     in order to determine a subset of patients in whom it will be safe to stop surveillance.   "
111154|NCT01831024|"     The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will     be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant     chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair     loss will be evaluated by patient self assessment of 5 standardized photographs taken prior     to each chemotherapy cycle. A concurrent control group not using a cold cap will also be     evaluated.   "
111155|NCT01831011|"     Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic     drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating     acute ischemic stroke.   "
111159|NCT01830959|"     Pulmonary sarcoidosis patients with fibrosis often develop recurrent episodes of bronchitis.     These can lead to worsening of disease for both the short and long term.      Roflumilast has been shown to reduce the number of acute bronchitis episodes in patients with     COPD.      Drugs similar to Roflumilast have been shown to help sarcoidosis. The current study is to     determine if Roflumilast will reduce number of episodes of bronchitis and help fibrotic     sarcoidosis.   "
111160|NCT01830946|"     Obesity is recognized as a major public health concern because of its link to potential fatal     complications arising from metabolic and cardiovascular diseases. Despite many     pharmacological advances in this field, lifestyle strategies that emphasize proper nutrient     intake and physical activity continue to be the primary strategy for individuals to fight     obesity. However, controversy exists regarding the type and timing of exercise and specific     nutrient intake to maximize fat loss, muscle gain, and beneficial cardio-metabolic     adaptations derived from these lifestyle interventions. Furthermore, limited data exists     investigating the impact of nutrient timing at times other than immediately before or after     exercise and no studies have examined time-of-day nutritional intake in overweight or obese     individuals.In addition, many individuals attempting to improve body composition and     cardio-metabolic health are concerned with what food choices are appropriate in the late     evening to support positive physiological adaptations. However, research-based information     examining this topic is scarce.      The investigators hypothesize that consumption of a protein beverage in the late evening     before sleep will improve body composition, cardio-metabolic health, and adaptations to     exercise more than an isocaloric placebo beverage. The investigators also hypothesize that     the different digestion and absorption kinetics of whey and casein proteins will elicit     different effects on the measures variables.   "
111161|NCT01830933|"     The proposed research combines the scientific advances in breast cancer research with health     information technology (IT) to design a personalized intervention that assesses breast cancer     risk for women, disseminates important breast health information, and facilitates discussion     of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal     computer) based breast cancer risk education (BreastCare) intervention in the primary care     setting that estimates a woman's individual risk for breast cancer and provides her and her     physician with personalized breast cancer risk information and recommendations for action.   "
111162|NCT01830920|"     The purpose of this study is to determine whether THR-184 when administered around the time     of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the     development of acute kidney injury.   "
111163|NCT01830907|"     Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients     at nutritional risk. The primary endpoint was the complication rate and the second endpoint     was the length of stay.   "
111164|NCT01830894|"     MRI research Group in the Advanced Technology Center of the Sheba Medical Center has     developed an innovative methodology based on leakage (extravasation) contrast agent that     allows to map the entire brain with high resolution and high sensitivity to check and     describe disorders BBB (blood brain barrier).      The aim of the current study is to evaluate the feasibility of the BBB disruption detection     method to predict delayed peri - hemorrhage edema.   "
111165|NCT01830881|"     The purpose of this study is to determine the level of pain, anxiety and side effects that     women experience with a surgical abortion and the effect that the anti-anxiety medication,     midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead     of the standard pain treatment of only ibuprofen and a PCB.   "
111183|NCT01830647|"     This prospective observational study will evaluate the safety and efficacy of first-line     Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice     in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for     the duration of their treatment and a 30-day follow-up after the last dose of study drug.   "
111166|NCT01830868|"     This is a Non-interventional Prospective Study. Centres will enroll adult patients with     partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive     therapy prior to the decision to take part in this study. Patients to be enrolled into the     study are not sufficiently controlled with one dug licensed for the use of monotherapy in     partial onset seizures. Patients will be seen at baseline and then during normal clinical     visits at intervals which are appropriate to the typical practice of the treating clinician.     Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.   "
111167|NCT01830855|"     This study is looking at a new vaccine that might prevent meningococcal disease, and will     study whether healthy adolescent subjects receiving different lots of vaccine respond in a     similar way. The study will also look at the safety of the new vaccine as well as how it is     tolerated.   "
111168|NCT01830842|"     The purpose of this study is to use functional magnetic resonance imaging (fMRI) to     investigate the acute and chronic effects of nicotine on motivational behavior and prediction     error-related neural activation. Nonsmokers (n = 24) and smokers (n = 24) will undergo fMRI     scans on two separate occasions while performing a decision-making task that will elicit     prediction error signals in the mesocorticolimbic pathway of the brain. Nonsmokers will be     scanned once following an acute dose of nicotine and once following placebo administration.     Smokers will be scanned once following smoking as usual and once following 24-hours of     smoking abstinence, in order to measure the effects of nicotine withdrawal. The study team     hypothesizes that acute nicotine will increase the prediction error signal in nonsmokers     compared to placebo, and that nicotine withdrawal will decrease the prediction error signal     in smokers compared to the normal satiated condition. Furthermore, nonsmokers (during the     placebo condition) will have greater prediction error activation than smokers (during the     satiated condition). The results of this study will inform whether the initiation and     maintenance of smoking behavior could be facilitated by the effects of nicotine on     reinforcement learning.   "
111185|NCT01830621|"     The purpose of this study is to find out whether it is better to receive a new drug, BBI608,     or better to receive no further treatment for colon or rectal cancer. To do this, half of the     patients in this study will get BBI608 and the other half will receive a placebo (a substance     that is designed not to do anything).   "
119665|NCT01719588|"     The purpose of this study is to evaluate the safety and effectiveness of prolonged release     tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among     Filipino patients.   "
111169|NCT01830829|"     Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45     associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms     and is in part related to prostate enlargement and obstruction. The standard medical therapy     for this condition includes 5-alpha reductase inhibitors -5ARI (eg dutasteride) or alpha     blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the     combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH     also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain     syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset of     patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS (organ     specific phenotype) is the third most prevalent prostate disease after prostate cancer and     BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant percentage of     urology outpatients (3-8% of male outpatient visits)resulting in a major impact on quality of     life of patients and economic costs to society. Clinical phenotyping allows for prediction of     the patients with CP/CPPS most likely to respond to dutasteride and tamsulosin (age, Lower     Urinary Tract Symptoms [LUTS] and prostate related phenotypes [BPH]). It can be estimated     that up to 30% of men currently diagnosed with CP/CPPS will include men with co-existing     Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of JALYN     (dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in men     diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower     Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg.     BPH and CP/CPPS).   "
111170|NCT01830816|"     This is a phase 1/1b, open-label, multicenter study of oral ixazomib (MLN9708)designed to     assess the pharmacokinetics (PK) of single dose ixazomib in patients with normal renal     function and in patients with severe renal impairment (RI) (according to Cockcroft-Gault     estimates). Twenty-eight PK-evaluable patients will be enrolled in either 1 of the 2 arms of     the study.      Arm 1: (N = 12): Normal renal function (creatinine clearance [CrCl] ≥ 90 mL/min)      Arm 2: (N = 16): Severe RI (CrCl < 30 mL/min) including at least 6 patients with ESRD,     defined as renal failure requiring hemodialysis   "
111171|NCT01830803|"     Quality of life and patient satisfaction are two important concepts in health care,     especially in chronic diseases. Currently, there are several instruments available to     determine this, but many are not easily applicable in daily practice because of their length     and the consequential effort they require from both patients and caregivers.      In the UK, Benson et al. recently developed two short generic patient questionnaires on     quality of life and patient satisfaction: the howRu and howRwe questionnaires. Both     questionnaires contain four items.      The howRU questionnaire has already been validated and seems highly applicable to be used in     large patient groups. The howRwe questionnaire has not been validated yet. The reliability of     both questionnaires has not been assessed either. The procedure as suggested by Kocks et al.     provides us with the opportunity to perform a reliability procedure on patient level.      The purpose of this study is to assess the reliability of the howRU and the howRwe     questionnaires on patient level in the Dutch population.   "
111181|NCT01830673|"     The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous     immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical     symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher)     were included. The patients were allocated to three study groups:      Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment)     Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant     grass pollen allergy without SCIT.      The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the     patients to record symptoms during the adjacent pollen season. A blood sample was drawn to     analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5,     IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).   "
111182|NCT01830660|"     Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of     increasing platelet count in animal and human. This study is designed in dose escalation     fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.   "
111852|NCT01821885|"     The aim of the study is to asses the efficacy of the spirometry and a minimal smoking     cessation counselling intervention to quit smoking after a year in patients older than 40     years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease     (COPD) diagnosis.   "
111172|NCT01830790|"     Choroidal thinning has been hypothesized to partake in the pathogenesis of age-related     macular degeneration (AMD), but it is not known if increasing choroidal thickness may     potentially alter the disease course. Past studies have shown that a single dose of the     phosphodiesterase type-5 inhibitor sildenafil citrate can increase choroidal thickness in     young healthy patients. The investigators hypothesize that sildenafil may also increase     choroidal thickness in eyes with AMD and perhaps potentially reduce AMD progression.     Alternatively, if sildenafil has minimal effect on choroidal thickness in eyes in patients     with AMD, such results may suggest that choroidal vascular compliance or stiffness is reduced     in this condition. Patients seen at the Duke Eye Center with a diagnosis of AMD or     age-matched control subjects with no macular pathology will be administered a single 100mg     oral dose of sildenafil citrate (Viagra®; Pfizer), and undergo EDI-OCT imaging before and     after treatment. Images obtained will be used to measure choroidal thickness, as well as     central macular thickness (CMT) and macular volume (MV). Choroidal thickness changes after a     single-dose sildenafil treatment in AMD patients will be compared with age-matched control     subjects using standard statistical methods. By also correlating choroidal thickness changes     with functional (visual acuity) and anatomical (CMT & MV) changes, the investigators hope to     further their understanding of the choroid's role in aging and AMD pathogenesis. The safety     of a single dose of sildenafil citrate will be addressed by excluding any patients with risk     factors or using medications that are contraindicated for sildenafil as determined by careful     informed consent and a study questionnaire.   "
111195|NCT01830491|"     The aim of this study is to demonstrate that the combination therapy of aspirin and     clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with     respect to its effectiveness in inhibiting platelet aggregation, if it is given for four     weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting     stent before > 12 months and had remained in a stable condition with a single antiplatelet     agent, aspirin.   "
111173|NCT01830777|"     This research study is a Phase I clinical trial. Phase I trials test the safety of an     investigational drug or combination of drugs. These trials also try to define the appropriate     dose of the investigational drug to use for further studies. Investigational means that the     combination of drugs is still being studied and that research doctors are trying to find out     more about it. As part of this research study, patients will be administered brentuximab     vedotin in combination with a conventional re-induction chemotherapy regimen called MEC,     which consists of the chemotherapy drugs mitoxantrone, etoposide, and cytarabine. Brentuximab     vedotin has not been approved by the FDA for the patient's cancer. However, brentuximab     targets a protein on tumors called CD30, and it is approved for other cancers which express     CD30, and these include Hodgkin lymphoma. This means that the FDA has not approved giving     brentuximab in conjunction with MEC for use in people, including people with this type of     malignancy, acute myeloid leukemia (AML).      Mitoxantrone, etoposide and cytarabine are chemotherapy agents that are commonly used to     treat individuals with relapsed AML. Brentuximab is an antibody-drug conjugate (ADC), which     is the combination of an antibody (a protein that binds to cells) and a drug. Brentuximab     vedotin works by using the antibody portion to enter into CD30-positive cells and then     releasing the drug portion, which attempts to destroy the cell. Brentuximab vedotin has been     used in laboratory and other research studies and information from those studies suggest that     brentuximab vedotin may slow down the spread of cancers which express CD30. Some AML cell     express CD30, so investigators hope that brentuximab vedotin will help with this type of AML.      The primary purpose of this research study is to determine the highest dose that Brentuximab     vedotin can safely be given with MEC without severe or unmanageable side effects. The dose     identified in this study will be used in future research studies.   "
111174|NCT01830764|"     The purpose of this study is assess the safety and tolerability of lemuteporfin topical     solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy     volunteers.   "
111175|NCT01830751|"     The purpose of the proposed study is to test the effect of an intervention technique that     reduces trunk flexion upon rising, on the outcome measures of self-reported back pain and     functional impairment in individuals with chronic or recurrent non-specific low back pain     (LBP). The intervention is a self-administered and requires no medical intervention or drugs.     The technique referred to as the restrained sitting treatment (RST), involves training in     minimizing forward bending of the trunk immediately upon rising. The technique builds upon a     previous randomized controlled study conducted and published by members of the research team.     The underlying premise of RST exploits the natural diurnal pattern as the intervertebral     discs (people are tallest when they first wake up). The discs are fully hydrated upon rising,     disc internal hydrostatic pressures and external forces acting on surrounding soft tissues     are greatest at this time, and these pressures and forces can increase significantly with     trunk flexion. The RST technique utilizes a back support used in sitting during the first     hour upon rising to minimize trunk flexion during this critical period as the intervertebral     discs begins the diurnal cycle of fluid loss. The study will test the null hypothesis that     there are no significant difference in outcome (LBP, work or social function/disability)     between groups performing RST, the experimental group performing RST upon rising, the control     group performing prior to going to bed.   "
111176|NCT01830738|"     The main objective of the study is the comparison of the effective duration of     hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical     technique versus an conventional multi-port technique.   "
111177|NCT01830725|"     Determine whether a relationship exists between polymorphisms of the genes XDH, HPRT1, and     PRPS1 and gout, hyperuricemia, or the dose of xanthine oxidase (XO) inhibitors to reach a     goal serum uric acid of less than 6 mg/dL. This study is observational in nature as no dose     adjustment of XO inhibitors will be made by study investigators.   "
111178|NCT01830712|"     This study is conducted in the United States of America (USA). The aim of this study is to     assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic     surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA     (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency     of bleeding episodes and durability of joint surgery.   "
111179|NCT01830699|"     To date no trials have been performed looking at whether or not intra-bursal injection of an     IL-1 antagonist provides pain relief similar to that of a corticosteroid injection. The     subcutaneous injection of anakinra, an IL-1 receptor antagonist, in patients with shoulder     pain due to rotator cuff tendonitis and subacromial bursitis was efficacious in relieving     pain but this information was presented as a case series in a letter to the editor format, so     the validity of these results would require additional testing [Omoigui S, et al. 2004].     Based mainly on the data from the intra-articular administration of anakinra, there have not     been any adverse trends in outcomes or safety to suggest that intra-bursal injection of     rilonacept will carry an increase risk of adverse events. The purpose of this trial is to     compare the improvement in pain and function of patients with clinical symptoms and signs of     subacromial bursitis of rilonacept vs. corticosteroid injection (standard of care).   "
111180|NCT01830686|"     The purpose of this study is to help understand the benefits of eating food supplemented with     fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on     glucose metabolism and body weight.   "
117994|NCT01741493|"     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose     study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and     multiple dose study in healthy volunteers.   "
111184|NCT01830634|"     Background: Accidental falls result in major physical and psychological morbidity in the     elderly.      Aim: To evaluate effects of lower-limb strength and flexibility program, which is analyzed     under the control of other risk factors, on preventing recurrent falls and fall- related     injuries in the community-dwelling elderly faller.      Methods: The randomized double blind, longitudinal study will enroll about 780 elderly     fallers, who are aged more than 70 years old. They are retrieved from the Adult Health     Examination and allocated into intervention group and control group. All the fallers have at     least one risk factor of accidental falls and no indication for exclusion criteria. Health     professionals assess the risk factors of falls and provide medical educations and suggestions     to all subjects concerning modification of environmental hazards, dizziness, multiple drugs     use, and general transfer skill, etc. Physical therapists instruct the elderly of     intervention group to do lower-limb strength and flexibility program by the aid of Theraband.     There are three times of variables measurement at baseline, 6 months and 12 months after     examination. Differences in baseline characteristics between groups are tested by independent     samples t test, Mann Whitney U test, or Chi-square test. To compare the outcomes in different     groups, the investigators evaluate balance and mobility with multiple linear regression,     accidental falls or not with logistic regression, and all-related injuries with Cox's     proportional hazard model.   "
145070|NCT01385527|"     The purpose of this study is to evaluate whether participation in an Internet-based     intervention helps improve atopic dermatitis treatment outcomes.   "
111186|NCT01830608|"     Age-related macular degeneration (AMD) is the leading cause of blindness in the Western     World. The etiology and pathogenesis of this disease remain largely unknown. In Europe about     two million people suffer from AMD. According to the Age-Related Eye Disease Study (AREDS)     the disease can be classified into early, intermediate and late. Early age-related macular     degeneration is characterized by the presence of small or medium-sized drusen and/or retinal     pigmentary abnormalities. Intermediate age-related macular degeneration is characterized by     large drusen or numerous medium-size drusen and/or geographic atrophy not extending to the     center of the macula. Late age-related macular degeneration can be either atrophic with     extension to the macula or neovascular. The late form of the disease is associated with a     pronounced loss of visual acuity.      In the recent years several studies focused on risk factors for late AMD and a recent     systematic review and meta-analysis reported risk factors for AMD based on 16 studies in     almost 114000 subjects. Strong and consistent associations with late AMD for found for     increasing age, current cigarette smoking, previous cataract surgery, and a family history of     AMD. Consistent associations between late AMD and higher body mass index, history of     cardiovascular disease, hypertension and higher plasma fibrinogen were also found, but the     association was weak. Inconsistent associations were found for gender, ethnicity, diabetes,     iris color, history of cerebrovascular disease, serum total and HDL cholesterol and     triglyceride levels.      Evidence has also accumulated that other factors influence the risk for AMD. Several genetic     risk factors have been identified in the last years including genes in the alternative     complement pathway and the RMS2/HTRA1 region. In addition, post-hoc analysis of data from the     AREDS study has indicated that reduced intake of the omega-3 free fatty acids     eicosapentaenoic acid and docsahexaenoic acid are associated with the risk of late AMD     thereby supporting previous population based studies. The AREDS study also revealed that     reduced intake of the macular pigment lutein and zeaxanthin may be associated with late AMD,     again supporting previous population-based studies. Finally, 2 small studies indicate that     reduced choroidal blood flow is associated with an increased risk of developing late AMD.      Less data are available for the progression of early or intermediate AMD and the associated     risk factors. This is at least partially related to the problems in quantifying progression     of drusen size and volume. In the recent years, however, significant efforts have been     achieved in optical coherence tomography (OCT)-based methods for quantifying drusen     progression and drusen volume. Polarization-sensitive OCT is the most promising of these     approaches and will be used to quantify drusen area and volume in the present study.   "
111187|NCT01830595|"     Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin     (1500mg bid) for reducing inflammation among HIV positive participants.   "
111188|NCT01830582|"     The purpose of this study is to see whether three new types of MRI techniques used during     magnetic resonance imaging (MRI) of the pelvis to look at rectal cancer can help doctors to     tell if the tumor is getting better in response to the radiation and/or chemotherapy     treatments.   "
111189|NCT01830569|"     The purpose of this study is to assess the feasibility of the use of an evidence-based     decision support system (EBMeDS) in daily Belgian family medicine and to study the     effectiveness of EBMeDS use on improving diabetes care.      Specific research questions are:        -  Does family physicians use the EBMeDS system in daily practice?        -  Does the use of the EBMeDS system by family physicians leads to an improvement in          diabetes control compared to the control group?   "
111190|NCT01830556|"     Primary To investigate in patients with relapsed or metastatic squamous cell carcinoma of the     head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel     and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab     and 5-FU, cisplatin or carboplatin based chemotherapy.      Secondary      To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and     neck the following study variables between both treatment arms:        -  Best overall response        -  Duration of response        -  Time to treatment failure        -  Overall survival        -  Safety   "
111191|NCT01830543|"     The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban     treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various     combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or     prasugrel or ticagrelor).   "
111192|NCT01830530|"     This study is aimed to assess the efficacy of combined treatment with two antihypertensive     agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high     altitude.   "
111193|NCT01830517|"     This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine     camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute     ischemic stroke by measuring their 24-hour ambulatory BP (ABP).   "
111204|NCT01830374|"     The purpose of this study is to examine biological (e.g., energy expenditure, neuroendocrine     and appetitive hormones)and behavioral (e.g., binge eating and purging) correlates of weight     suppression and current dieting status in women with bulimia nervosa. The investigators have     differentiated between a diet-induced long-term energy imbalance (weight suppression, or the     difference between one's highest-ever body weight and current weight) and a short-term energy     imbalance (current dieting to either lose weight or avoid weight gain). This study will     elucidate how two common yet largely unexplored types of dieting influence biological and     behavioral variables in patients with bulimia nervosa, which could lead to modifications of     prevailing models of bulimia nervosa and new strategies for improving treatment outcome.   "
111205|NCT01830361|"     To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated     t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation   "
111194|NCT01830504|"     In France, 7-8 000 new thyroid cancer cases are diagnosed each year. Although a good overall     prognosis, it is usually estimated that 10 to 20% will rescue and 5% will become metastatic.      The standard treatment of advanced metastatic or recurrent thyroid cancer is limited to     radioiodine therapy. It is estimated that 30 to 50% of patients will become resistant to     radio iodine. Treatments options are limited in these refractory thyroid patients and long     term survival is estimated to less than 10%. Nowadays, no drug is approved in this     indication.      The recent explosion in knowledge in tumour biology and the identification of potential     biological targets in thyroid cancer led to several clinical trials with targeted therapies,     mainly focused on TKI inhibitors targeting the MAPkinase pathway and/or VEGF. Preliminary     results were encouraging in papillary thyroid tumors.      Follicular (FTC) and poorly differentiated thyroid (PDTC) cancers account for 10% of thyroid     cancer but 20-25% of cancers diagnosed at an advanced stage and near 50% of metastatic     refractory thyroid cancers. These cancers with an aggressive behavior represent a major cause     of death from thyroid cancer. In these subtypes, targeted therapies gave disappointing     results. This may be related to the mutational profile of these tumors which is different     from that of papillary cancers. Aberrant activation of the phosphatidylinositol-3-kinase     (PI3K)/AKT pathway is thought to play a fundamental role in thyroid tumorigenenesis of     follicular and poorly differentiated thyroid cancers. Many genetic alterations have been,     recently, identified in this pathway. PIK3CA mutations are found in 10-15% of FTC and can     also occur in metastases derived from PDTC. Amplification/genomic copy gain of the PIK3CA has     been identified in 24% of FTC and 42% of PDTC. Epigenetic inactivation of PTEN which     negatively regulates PI3K has been shown in FTC. Moreover, RAS mutations observed in 20-40%     of FTC and PDTC can activate the PI3K/AKT by interacting with the RAS-binding site of the     P110 catalytic subunit of PI3K.      Due to the high frequency of activation of PI3K and downstream effectors in progressive,     recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with     BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic     target and should be properly evaluated in advanced follicular and poorly differentiated     thyroid carcinomas   "
111196|NCT01830478|"     The purpose of this study is to determine whether lenalidomide in association with rituximab     is effective in the treatment of patients with indolent non follicular NHL relapsed after     >=2, but less than 4 prior lines of (immuno)chemotherapy.   "
111198|NCT01830452|"     Chronic pain after Lichtenstein hernioplasty is a common problem with an incidence of 11%.     Many factors influence the onset and persistence of pain. Mesh characteristics and fixation     have been pointed as important etiologic factors. This study compares two types of fixation     for the same mesh. The mesh used is a lightweight parietex mesh. In the control group this     mesh will be fixed with non absorbable sutures. In the study group sutures will not be needed     because of self gripping microhooks on the surface of the mesh.      Methods: The HIPPO trial is a multicenter double blind randomized clinical trial. Patients     will be randomly allocated to the sutured mesh or the self-gripping mesh. Hernia repair will     be done according to Lichtenstein as described by Amid et all. Included will be all     unilateral primary inguinal hernia in man patients aged 18 years or older not meeting the     exclusion criteria. Patients will be followed for two years. The main endpoint is the amount     of post-operative chronic pain evaluated by VAS scores. The existence of neuropathic pain     will be evaluated by the Paindetect questionnaire (and a bedside variant of the QST).     Secondary endpoints are recurrence rate, post-operative complications, costs, hospital stay,     QOL, return to work and daily activities, genital and sexual problems. To demonstrate a     difference in VAS score of 10 with α=0.05 and power 80% a sample size of 400 patients is     calculated.      Discussion: Hypothesized is that the self gripping non-sutured mesh (Parietex Progrip) will     cause less post-operative and chronic pain without enhancing the recurrence rate.   "
111199|NCT01830439|"     This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period,     two-sequence, crossover, open-label study to evaluate the effect of food on the     pharmacokinetics of PA-824. The hypothesis to be tested in this study is that the rate and     extent of absorption of two doses of PA-824 (50mg or 400 mg and 200mg) are the same after a     high-calorie, high-fat meal as compared with after a minimum 10-hour fast.      For each of the two dose levels 16 subjects with approximately 8 men and 8 women, will be     enrolled for a total of 32 subjects.   "
111200|NCT01830426|"     The purpose of this study is to establish the circulating tumor cell (CTC) assay as a     surrogate for tissue diagnosis of suspected primary lung cancer. This is done through     evaluating clinical and molecular markers to stratify the outcome/survival in patients with     thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of     California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.   "
111201|NCT01830413|"     Stenting for systematic Intracranial artery stenosis is challenged recently, especially for     safety. This registry is aimed to explore the safety profile during peri-operation period in     Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real     world.   "
111202|NCT01830400|"     This was a Non-interventional Prospective Study. Centres enrolled adult patients with     partial-onset seizures with or without secondary generalisation for whom the clinician had     decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the     decision to take part in this study. Patients enrolled into the study were not sufficiently     controlled with one drug licensed for the use as monotherapy in partial-onset seizures.     Patients were seen at baseline and then during normal clinical visits at intervals. Patients     in this study were assessed for efficacy and tolerability at baseline and then at least 3 and     6 months after the baseline.   "
111203|NCT01830387|"     The purpose of this study is to compare the clinical outcomes and the operative costs of     appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers.     Prospective data will be collected before, during, and after surgery on patients undergoing a     laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after the     appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy patients at     Duke Regional Hospital. Retrospective data will be collected from patients who had an     appendectomy prior to 1/2012 using a different clip as part of their surgery, or an open     appendectomy to compare outcomes.   "
111206|NCT01830348|"     The purpose of the study is to determine if DSC127 is effective in increasing incidence of     complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the     vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have     chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.   "
111207|NCT01830335|"     Environmental stress, such as low oxygen availability (hypoxia), has been associated with     impaired neuromuscular performance; however, the mechanisms associated with these performance     decrements remain unclear. While the majority of research suggests that the observed fatigue     is related to the central nervous system, the influence of changes in cerebral blood flow     (CBF) and associated changes in cerebral pH (partial pressure of carbon dioxide; PCO2)     remains unexamined. In response to hypoxic stress, humans hyperventilate to maintain oxygen     consumption, resulting in a hypocapnia mediated decrease in CBF and cerebral alkalosis     (decreased PCO2). Previous research suggests that hyperventilation induces changes in neural     excitability and synaptic transmission; however, it remains unclear if these changes are     related to hypocapnia mediated decrease in CBF or cerebral alkalosis or both.      The purpose of the proposed research program is to examine the influence of changes in CBF     and cerebral alkalosis on neuromuscular function during environmental stress. The research     program will consist of 2 separate projects, summarized below in a table outlining the     proposed protocols and resultant physiological manipulations. During each manipulation,     neuromuscular function will be evaluated and compared to baseline (normoxic) conditions using     a repeated measures design.      The research program will consist of 2 separate projects. Project 1 will examine the changes     in CBF and alkalosis by using (a) indomethacin (decrease CBF; no change PCO2) and (b)     hypocapnia (decrease CBF; decrease PCO2). Using a similar experimental design, Project 2 will     examine the change in CBF and alkalosis during hypoxia by using (a) poikilocapnic hypoxia     (decrease PO2; decrease CBF; decrease PCO2), (b) isocapnic hypoxia (decrease PO2; no change     CBF; no change PCO2) and (c) isocapnic hypoxia + indomethacin (decrease PO2; decrease CBF; no     change PCO2). During each manipulation, neuromuscular function will be evaluated and compared     to baseline (normoxic) conditions using a repeated measures design.      Therefore, Project 1 will examine the separate and combined effect of changes in CBF and     cerebral alkalosis on neuromuscular function independent of environmental manipulations.     Subsequently, Project 2 will examine neuromuscular function during hypoxia while controlling     CBF and cerebral alkalosis. It is hypothesized that changes in PCO2 and therefore, changes in     cerebral alkalosis will contribute to neuromuscular fatigue independent of changes in CBF and     oxygen availability.   "
111208|NCT01830322|"     This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients     with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The     secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free     Survival (PFS), and safety.   "
111209|NCT01830309|"     -  Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of          CJ-12420 in healthy male subjects.        -  Secondary             -  To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420               in healthy male subjects(PD/PK group)             -  To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects               under fed or fasting condition.   "
111210|NCT01830296|"     Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized     study tested the effects of coadministration of patient controlled remifentanil+morphine     combination on postthoracotomy pain, analgesic consumption and side effects compared with     morphine PCA alone   "
145349|NCT01381887|"     The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose     blood levels in patients with Type 2 Diabetes Mellitus.   "
111212|NCT01830270|"     If surgery remains the main treatment for gastric cancer without distant metastases;     perioperative-chemotherapy increased the likelihood of progression free survival.     Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to     improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative     chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to     treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients     could received post-chemotherapy, due to post-operative complications and toxicities. To     overcome this limitation, the investigators will conduct a phase II clinical trial assessing     the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P),     epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer     treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and     paclitaxel/epirubicin combinations, sustain the development of dose density based on PET     combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the     effectiveness of this PET preoperative regimen   "
111213|NCT01830257|"     The investigators would remind the guardians of observation after immunization via sending     short message and collect the information of AEFI by two ways, short message/telephone and     website questionnaire.   "
111214|NCT01830244|"     The aim of this project is to evaluate tailored primary systemic therapy with sequential nab     paclitaxel and epirubicin and cyclophosphamide in early breast cancer. This study will be an     open label phase II clinical trial. The hypothesis is that tailored neoadjuvant chemotherapy     with sequential nab paclitaxel and epirubicin and cyclophosphamide is feasible and achieves     high response rates. It is proposed that 60 patients will be enrolled in this study including     40 patients which are likely to have chemotherapy sensitive tumors and 20 patients who have     ER positive tumors and are more likely to respond to hormonal treatment as an exploratory     cohort. The target population is women with early breast cancer who are eligible for primary     systemic therapy. The overall response rate in the breast will be measured. Secondary     endpoints will include response rates in axillary lymph nodes, safety and tolerability and     the rate of breast conservation. Participants will have a blood test to determine a specific     genotype status that may help in predicting sensitivity to chemotherapy. This genotype test     result is exploratory and will not influence selection of therapy for participants. Patients     will also be given the option of having he their tumour tissues used in laboratory studies     involving isolating cancer initiating cells from the tumor to subsequently generate breast     cancer models in the laboratory and using aptamers (chemical antibodies) to target tumours.   "
111215|NCT01830231|"     Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised     phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR)     are sufficiently high to further study the treatment regimens in a phase III setting.   "
111216|NCT01830218|"     A national survey of current practices, preferred drug and technique choices for obstetric     anesthesia and analgesia in Czech Republic.   "
111217|NCT01830205|"     The purpose of this study is to assess the effect of renal function impairment on the single     dose pharmacokinetics of Daclatasvir.   "
111218|NCT01830192|"     The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial     Malignancy (REM) in women with ultrasound endometrial abnormalities.   "
111247|NCT01829802|"     The purpose of this pilot study is to assess the efficacy and safety of the combination of     RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic     failure and PI and TDF naïve.   "
111327|NCT01828762|"     Although liver resection, liver transplantation, a-interferon, Transarterial Chemo     Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation     therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the     high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous     Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection     and TACE Therapy will be evaluated.   "
111219|NCT01830166|"     This project will develop and evaluate a treatment plan for prostate focal therapy based on     low dose rate brachytherapy. The participants entering this study are those suitable for     active surveillance. These participants will be monitored with various imaging methods and     interventions such as MR elastography, Transrectal ultrasound elastography, PET/CT and     transperineal mapping biopsy to determine the extent of cancer and suitable treatments. Those     suitable for focal therapy will be offered the option of low dose rate brachytherapy (LDRB)     focal therapy in addition to active surveillance or radical therapy.      This study will be used to evaluate the long term use of multi-modal, multi-parametric     prostate cancer imaging, combining data from MRI, ultrasound and 11C-choline PET/CT. Such     methods can be used to eliminate the need for invasive methods such as mapping biopsies.   "
111220|NCT01830153|"     This trial intends to test the efficacy and safety of RAD001 in patients with advanced     sarcoma who failed to conventional chemotherapy.   "
111221|NCT01830140|"     This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or     ocular hypertension (OHT).   "
111222|NCT01830127|"     To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir     /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA)     (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of     GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).   "
111223|NCT01830114|"     The objective of this pilot study is to evaluate the feasibility and technical merit of a web     application for patients in primary care called Check-up and Choices (CC).   "
111224|NCT01830101|"     The investigators hope to improve overall median survival of patients with recurrent     Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five     treatments of re-irradiation.   "
111382|NCT01828034|"     The purpose of this study is to test an investigational combination of drugs for bile duct or     gallbladder cancers. Gemcitabine and cisplatin are two forms of chemotherapy commonly used in     combination to treat bile duct and gallbladder cancers. The investigators are looking to     improve treatment results. They will attempt to do so by adding the drug MEK162 to the     treatment plan. MEK162 acts by blocking a protein called MEK 1/2 which helps cancer cells     grow and divide. This study will help answer the question of whether MEK162 is a helpful drug     in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.   "
111225|NCT01830088|"     Major depressive disorder (MDD) affects about 5% of adolescents and is on the rise both     internationally and in Norway. Further, it is also associated with increased risk for     suicide. Not surprisingly, depression is the largest reason for referral to specialty mental     health services for adolescents (13-17 years) in Norway. Although anti-depressants and     Cognitive behavioral therapy are strong treatments and have received extensive research, the     best treatments show a recovery rate of only 37 %.      There is a need to develop and test alternative treatments that can stand alone or augment     anti-depressant medication. Family factors play an important role in the etiology,     maintenance and relapse of depression. A promising family-based treatment (Attachment based     family therapy- ABFT) was imported to Norway and its feasibility tested in a pilot randomized     clinical trial with 20 families. The results showed promising treatment outcomes. Although     the developers of the model have refined, adapted the model to suicidal ideation and built     strong technology to support dissemination, a definitive study of ABFT for adolescents with     major depression has not yet been conducted. Therefore the primary aim of this study is to     test if ABFT is more effective that enhanced usual care (EUC) to treat clinic-referred     adolescents with major depression. The investigators will test the hypothesis that 12 weeks     of ABFT therapy will produce a greater proportion of adolescents report remission from     depression and symptom change than 12 weeks of enhanced clinical care (EUC). Secondary     research aims are i) to test a hypothesis that parent-adolescent conflict will be more     sensitive to change for adolescents receiving ABFT that adolescents receiving EUC ii) to     explore patterns of change in suicidal ideation in the recruited sample in the acute-phase     treatment.      Central challenges to the study are i) blinding therapists/patients, which is difficult in     psychotherapy trials ii) lack of a standardized control condition, and iii) selecting and     training regular staff therapists to high adherence levels. However, with tighter control     over these factors than is normal for a typical effectiveness trial, the investigators expect     results to show what to expect under the best of conditions in community clinics. Benchmark     derived from the study will inform how to effectively train therapists and subsequently     implement the model into mainstream services.   "
111226|NCT01830075|"     Background:      It is widely recognised that spiritual care plays an important role in physical and     psychosocial well-being of cancer patients but there is little evidence based research on the     effects of spiritual care. The investigators will conduct the first randomized controlled     trial on spiritual care using a brief structured interview scheme supported by an     e-application. The aim is to examine whether an assisted reflection on life events and     ultimate life goals can improve quality of life of cancer patients.      Design:      Based on the findings of the investigators previous research, the investigators have     developed a brief interview model that allows spiritual counselors to explore, explicate and     discuss life events and ultimate life goals with cancer patients. To support the interview,     the investigators created an e-application for a PC or a tablet. To examine whether this     assisted reflection improves quality of life the investigators will conduct a randomized     trial. Patients with advanced cancer not amenable to curative treatment options will be     randomized to either the intervention or the control group. The intervention group will have     two consultations with a spiritual counselor using the interview scheme supported by the     e-application. The control group will receive care as usual. At baseline and one and three     months after randomization all patients fill out questionnaires regarding quality of life,     spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health     care consumption.      Discussion:      Having insight into one's ultimate life goals may help to cope with a life event such as     cancer. This is the first randomized controlled trial to evaluate the role of an assisted     structured reflection on ultimate life goals to improve patients' quality of life and     spiritual well being. The intervention is brief and based on concepts and skills that     spiritual counselors are familiar with, it can be easily implemented in routine patient care     and incorporated in guidelines on spiritual care.   "
111227|NCT01830062|"     The aim of this study is to compare the relationship between the coronary artery     calcification assessed by MDCT with the plaque characteristics and necrotic lipid core     content of non-intervened coronary segments assessed with near infrared spectroscopy (NIRS)     in patients with symptomatic coronary artery disease (CAD).   "
111228|NCT01830049|"     Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging     population and the increase in life expectancy, an increase in the prevalence of ED is     expected in the years to come. Currently, the mechanism of ED is not fully understood.     MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression     post-transcriptionally. It has been included in many in vitro physiology and pathophysiology     processes, which also involved in the process of ED. This research was designed to     investigate the differential plasma MiRNA profiles in ED and normal erectile function in     older males. The results might tell us which MiRNA and how did it involved in the process of     ED in aging.   "
111229|NCT01830036|"     Prevalence of sleep-related breath disturbance in patients in cardiac rehabilitation.      The aim of the register is to enable a better diagnosis and early treatment initiation in the     context of secondary prevention. In addition to the prevalence, the further course of the     patients shall be documented after hospital discharge to verify any gaps (sleep laboratory,     therapy introduction) and emphasize the importance of rehabilitation and to examine the     possibility of initiating therapy in rehabilitation.   "
111230|NCT01830023|"     This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination     will be done and the data will be compared to the other examinations.   "
111231|NCT01830010|"     Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part     2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for     hematological malignancies   "
111350|NCT01828463|"     SONIA 1 is an international, multicentre, randomised, open-label, no-treatment controlled,     parallel group, dose-response study to investigate the effect of once daily nitisinone on     24-hour urinary homogentisic acid excretion in patients with alkaptonuria after 4-weeks     treatment. They study will identify the optimal dose to decrease urine homogentisic acid to     near normal levels.   "
111232|NCT01829997|"     Spine fusion is one of the most common procedures performed in spinal surgery. Several     surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion     (PLF) is the most widely used. However, complications can develop when the bone graft     material used is insufficient to achieve the desired fusion. With its unique properties,     nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain     new bone growth during the healing process.      nanOss Bioactive 3D is approved for use in the U.S., however, additional information is     useful to assess its efficacy in the posterolateral spine. The purpose of this study is to     assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with     autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in     fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of     translational motion, and less than 5 degrees of angular motion.   "
111233|NCT01829984|"     The purpose of this study is to compare two different ways of teaching people how to give     injections at home. The first is what we do now, which is teaching patients and/or their     caregivers verbally and by giving written instructions. The second is what we do now (verbal     and written instructions) along with a demonstration and practice using a needle and an     injection pad that feels similar to skin and fat. This is being done to find the best method     for teaching people to give an injection at home.   "
111234|NCT01829971|"     This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or     other selected solid tumors or hematologic malignancies. The drug is given intravenously, for     5 days in a row and then two weeks off.   "
111235|NCT01829958|"     This study will evaluate the ability of a largely self-administered geriatric assessment (GA)     to predict toxicity in non-Hodgkin Lymphoma (NHL) patients ≥60 years old receiving     chemotherapy or chemoimmunotherapy.   "
111236|NCT01829945|"     Several lines of evidence indicate that a significant proportion of cardiovascular disease     (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and     perturbations, defined as the metabolic syndrome. It has been estimated that approximately     25% of the North American adult population is living with the metabolic syndrome. Recent     studies show that overaccumulation of atherogenic triglyceride-rich lipoproteins (TRL) seen     in insulin-resistant patients is partly due to increased production rate of intestinally     derived apolipoproteinB-48-containing lipoproteins. This is of interest because substantial     evidence exists indicating that elevated levels of intestinal lipoproteins are associated     with increased CVD risk. However, as indicated in the body of this grant proposal, the     underlying mechanisms that lead to intestinal overproduction of lipoproteins in     insulin-resistant states are poorly understood.      The general objective of the proposed research is to investigate the mechanisms by which the     metabolic syndrome affects apolipoproteinB-48 secretion in human. The primary hypothesis is     that insulin resistance will be associated with higher levels of intestinal lipoproteins     because of an increased secretion of these particles.   "
111237|NCT01829932|"     Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose     symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to     influence the bacteria gut interaction. Our aim is to determine if components of the diet     affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure     whether after being on a diet high or low on certain factors there is a change in the timing     and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS     symptom severity.   "
111238|NCT01829919|"     The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and     elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate)     Capsules 7.5 mg when given as a single dose and multiple doses.   "
111239|NCT01829906|"     Bariatric surgery is the only long-term established treatment for morbid obesity. However,     some patients experience suboptimal weight loss after surgery and/or experience a significant     weight regain. Unfortunately there are very few studies in this area and little is known     about the causes for lack of success or the best approach to treat this group of patients.     The main aim of this study is to compare the efficacy of two different lifestyle treatment     programs in this group of patients: 1) Hospital-based outpatient program or 2) an inpatient     treatment program consisting of 3 - 3-week stays at a rehabilitation center over a 1-year     period. Secondary aim is to determine potential reasons for suboptimal weight loss after     bariatric surgery.   "
111240|NCT01829893|"     To compare the relative bioavailability and pharmacokinetic characteristics of a newly single     pill combination of finasteride and tamsulosin with a conventional combination of finasteride     and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence     -2period crossover study.   "
111241|NCT01829880|"     The purpose of this study is to determine if cachexia and changes in body composition     influence pharmacokinetics of bisoprolol and ramipril and the accuracy of equations for renal     function estimation.   "
111242|NCT01829867|"     The purpose of this study is to assess the safety and tolerability of a dose of 95μg sNN0031     after intracerebroventricular administration to patients with Parkinson's disease   "
111243|NCT01829854|"     This is a study to investigate the incidence of Obstructive Sleep Apnoea in Patient     undergoing open heart Surgery . This will include enrolment of 400 patient undergoing open     heart surgery .   "
111244|NCT01829841|"     -  Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1          and Flt3. Phase I study has shown that the toxicity is manageable.        -  The purpose of this study is to compare the efficacy and safety profile between          Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.   "
111245|NCT01829828|"     The purpose of this survey is to investigate the usefulness of a patient self-reported     scoring tool on patient satisfaction improvement.   "
111246|NCT01829815|"     The aim of this study is to assess the impact of an intervention to improve parenting     practices, pre-academic and developmental skills, and use of mosquito nets for children in     kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist controlled     design will be conducted to measure the impact of the intervention on three primary outcomes:     positive parenting skills, children's cognitive and educational skills, and malaria knowledge     and prevention behaviors.   "
111248|NCT01829789|"     The purpose of this study is to test the efficacy and cost-effectiveness of Community     Reinforcement Training (CRT) provided in a group therapy format. The goals of CRT are to     teach parents behavioral and communication skills to influence their youth's drug use and     encourage them to enter treatment. Thirty parents will be randomly assigned to Group CRT and     30 will be randomly assigned to traditional, Individual CRT. Youth engaged in treatment will     receive individual Cognitive Behavioral Therapy. Families are assessed for adolescent     substance use and other areas of individual and family functioning. It is expected that Group     CRT will be more effective for encouraging youth entry into treatment and improving parental     functioning.   "
111249|NCT01829776|"     This pilot study will compare how often people with multiple sclerosis (MS) fall before     participating in the Free From Falls (FFF) educational program, during the program, and for 8     weeks after the program. The protocol will also evaluate the accuracy, efficiency and     convenience of an email survey to count how often people fall.   "
111258|NCT01829659|"     This study is being done to assess the effects of the CTP inhibitor on the function of your     platelets (cells within your blood that are involved in the formation of blood clots) and to     assess whether you have responded to the ticagrelor well enough to prevent the formation of     blood clots within the stent or site in which angioplasty was performed.      Recent studies have looked at how racial differences can affect platelet reactivity, the way     blood clots. But these studies have not looked at the way different racial backgrounds can     affect the way the blood forms clots. Minorities, such as African-Americans are     underrepresented. Therefore, we are conducting this platelet reactivity study to better     understand if there are differences in how this drug affects African-Americans from how they     affect Caucasian patients undergoing percutaneous coronary intervention and receiving     ticagrelor. These data will be compared to a historical control of Caucasian patients who     underwent similar platelet function testing.   "
111250|NCT01829763|"     Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic     stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often     display spasticity due to the interruption of the descending pathways that control the spinal     reflex networks, which results in hyperexcitability of the monosynaptic reflex triggered by     stretch of the muscle spindles. Spasticity in lower limb muscle impairs the gait, especially     in strokes that are the main cause of neurological disability. While 80% of the stroke     survivors recover the ability to walk, the poor quality of their gait constitutes a serious     handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).      Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal     spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle     contraction by blocking the release of acethylcholine from motoneuron terminals at the     neuromuscular junction and transiently paralyzing the muscle for several months. Besides this     peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004; Gracies     2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the fusimotor     synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al. 2008;     Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may be     indirectly responsible for functional changes in central motor mechanisms at both spinal and     supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde     axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal     cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological     findings are limited and controversial, probably due to the various motor disorders     investigated, the physiological mechanisms tested and the different toxin injection protocols     used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997; Modugno et     al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995; Wohlfarth et al.     2001). Hence, the central action of the toxin in spasticity remains uncertain.   "
111251|NCT01829750|"     The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac     progenitor cells in patients with univentricular heart disease. Patients with preoperative     high-risk group or whose cardiac function did not recover postoperatively eventually have no     choice other than heart transplantation.   "
111252|NCT01829737|"     Background:      - Malaria is an illness caused by a parasite spread by mosquitoes. When a mosquito bites a     person who is infected with a kind of parasite called a gametocyte, it is able to spread the     infection to another person. Not everyone infected with parasites have gametocytes in their     blood. As a result, not everyone can spread malaria to others. Researchers are interested in     learning more about why some healthy people have gametocytes in their blood and others do     not. Identifying the people who have gametocytes in their blood can help target treatment and     reduce the spread of malaria. This study will focus on the people of the village of Kenieroba     in Mali, where malaria is common.      Objectives:      - To study the relationship between gametocytes and malaria transmission in Mali.      Eligibility:      - Individuals between 6 months and 65 years of age who live in Kenieroba, Mali, and will stay     in the area for 1 year.      Design:        -  For 1 year, participants will have study visits once every 2 weeks (twice a month, for a          total of 24 visits). The visits will last 30 minutes each.        -  At each visit, participants will provide a small blood sample. They will report any          symptoms of malaria such as fever, headache, and body aches. Participants will be          encouraged to seek medical treatment if they experience malaria symptoms between visits.        -  Participants who have malaria symptoms will have a blood test for malaria parasites.          Those who have parasites in the blood will receive antimalarial treatment.        -  Three times over 1 year, a larger blood sample will be collected. These blood samples          will be taken once in the dry season, once in the wet season, and once in the next dry          season.        -  Women between 14 and 45 years of age will also provide urine samples to test for          pregnancy. Pregnant women will not be asked to give blood samples.   "
111253|NCT01829724|"     Background:      - Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS)     and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it     is active. EEG records electrical activity in the brain. Both have been used safely for many     years, even in very young children. NIRS or EEG can be used while a person is moving to show     which parts of the brain are the most active. Researchers want to use NIRS and EEG to study     brain activity during movement in people with cerebral palsy and healthy volunteers. Learning     more about how people with and without cerebral palsy use their brain to control their     muscles may lead to new ways of training people with cerebral palsy to move better.      Objectives:      - To study how the brain controls body movement in people with and without cerebral palsy.      Eligibility:        -  Individuals at least 5 years of age who have cerebral palsy.        -  Healthy volunteers at least 5 years of age.      Design:        -  This study has three parts. People with cerebral palsy will be selected for all three.          Healthy volunteers will be asked to do only two of them. Everyone who participates will          have NIRS and/or EEG exams during movement. People with cerebral palsy may also have          biofeedback sessions to train coordination of movement and brain activity.        -  Participants will be screened with a physical exam and medical history. Urine samples          may be collected.        -  All participants will have at least one session of NIRS and/or EEG imaging studies.          Sessions may also include the following tests:        -  Magnetic resonance imaging to look at the brain        -  Electromyography to measure electrical activity of the muscles        -  Motion analysis of specific body parts        -  Ultrasound to measure activity of the muscles        -  Motorized, robotic, and electrical stimulation of the muscles        -  Other clinical tests of muscle movement as needed.        -  Participants with cerebral palsy will have biofeedback sessions. These sessions will          help them learn to coordinate muscle movement and brain activity.   "
111254|NCT01829711|"     Background:      - Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets     CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab     pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a     phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile     supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase     III multicenter trial designed to confirm these results.   "
111255|NCT01829698|"     Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical     effectiveness of UDCA may be limited by its poor absorption and extensive     biotransformation.The more hydrophillic bile acid tauroursodeoxycholate (TUDCA) is the active     ingredients of UDCA,and has been approved by state food and drug administration in China for     treatment of cholesterol stones.So it is necessary to verify the efficacy and safety of TUDCA     in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,     double -dummy, parallel-controlled and multicenter clinical trial, we detect the proportion     of patients who had AKP decline more than 25% as the primary outcome;decline of ALP,total     bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated with TUDCA or     UDCA for 24 weeks.   "
111256|NCT01829685|"     The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0     mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B     patients with inadequate response to NUC therapy   "
112287|NCT01816191|"     The study is a single-center, open-label, safety and pharmacokinetic study in12 adult     subjects with Anal Fissures. Subjects will be screened to determine eligibility within 7 days     of treatment. There will be three parts to the study and all subjects will participate in     each part.   "
111257|NCT01829672|"     The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of     pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In     this prospective study the investigators validate DE-CT results of patients against     hemodynamic parameters from right heart catheterisation and control the results by other     clinical investigations. The investigators expect that using this non-invasive method,     parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume,     blood flow and perfusion heterogeneity, can be determined.   "
111383|NCT01828021|"     The purpose of this study is to determine if margetuximab is effective in the treatment of     certain patients with relapsed or refractory advanced breast cancer.   "
111384|NCT01828008|"     To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in     refractory and/or chemoresistant lymphomas.   "
111259|NCT01829646|"     Despite uniform histopathological definition the response of locally advanced squamous cell     carcinomas of the head and neck (HNSCC) to ionizing radiation differs greatly with     locoregional recurrences burdening this patient population. The addition of concurrent     chemotherapy and the use of altered fractionation schedules has significantly increased     locoregional control and overall survival over the last decade however, this has come at the     cost of increased acute and late toxicity, preventing further treatment intensification in     all patients. If the investigators want to increase the therapeutic index of HNSCC, we need     to be able to tailor the treatment more individually to each patient. The project aims at     developing a prognostic model for head and neck cancer patients based on the combination of     known clinical parameters with 1) genetic characteristics of the tumor and 2) parameters     derived from diffusion weighted and dynamic contrast enhanced magnetic resonance imaging     (MRI) obtained before and during treatment. The investigators plan a prospective trial where     120 patients with locally advanced head and neck cancer treated with chemoradiotherapy will     be included. Prior to treatment biopsy material will be collected for genetic analysis and     before and during treatment functional MRI with diffusion weighted and dynamic contrast     enhanced imaging will be performed. All patients will be followed up multidisciplinary     afterwards with follow-up of tumor status and toxicity.   "
111260|NCT01829633|"     Study population: Patients who have been treated with physiotherapy for a potentially     repairable rotator cuff tear in the period from 2002 to 2005.      Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined     clinically, sonographically and by MRI. Some patients also completed a shoulder score. All     study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination     includes history taking, clinical examination, completion of three shoulder scores (two     shoulder specific scores, one general health score), Sonography and MRI. Findings of interest     are        -  the number of relapses during follow-up,        -  the need for surgical treatment during follow-up,        -  the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during          follow-up        -  the actual clinical shoulder condition (as given by shoulder scores) at reexamination.      Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy     for potentially repairable rotator cuff tears. We want to find out if tear anatomy of     unrepaired rotator cuff tears deteriorates over time and if such a deterioration is     associated with a development of more serious degrees of symptoms.   "
111261|NCT01829620|"     The investigators propose to utilize text messaging to create and investigate the efficacy of     a Continuing Contacts via Text (CCVT) intervention that extends the continuity of care for     Service Members with a recent suicide attempt and/or reported suicidal ideation by sending     them non-demanding caring text messages at regular intervals over a 12-month period.     Participants will be randomly assigned to receive Continuing Contacts via Text (CCVT) in     addition to Treatment as Usual (TAU) or TAU alone.      Aim 1: To determine if the addition of 12 months of CCVT to TAU (CCVT+TAU) results in lower     rates of suicidal ideation and behavior relative to TAU alone.        -  Hypothesis 1a: Participants assigned to CCTV+TAU compared to TAU alone will experience          reduced suicidal ideation at 12-month follow-up.        -  Hypothesis 1b: Over the 12 months following study enrollment, a smaller proportion of          participants assigned to CCVT+TAU vs. TAU alone will have suicide risk incidents (i.e.,          those requiring medical evacuation or hospital admission).        -  Hypothesis 1c: Over the 12 months following study enrollment, CCVT+TAU vs. TAU alone          will have fewer total number of suicide risk incidents requiring medical evacuation or          hospital admission.      Aim 2: To test two proposed mechanisms of action of CCVT outcome: 1) reduced thwarted     belongingness and 2) increased engagement in behavioral health services.        -  Hypothesis 2a: The effect of CCVT+TAU compared to TAU alone will be mediated by          reductions in thwarted belongingness from pre to post-study.        -  Hypothesis 2b: The effect of CCVT+TAU compared to TAU alone will be mediated by          increased use of outpatient behavioral health services in the CCVT+TAU condition.   "
111262|NCT01829607|"     The purpose of this study is to evaluate the effects of functional electrical stimulation of     peripheral muscles on clinical and emotional status, endothelial function and left     ventricular diastolic function in heart failure with preserved left ventricular ejection     fraction.   "
111263|NCT01829594|"     The aim of is to test the effects of a model for care (case management) to older people with     high healthcare consumption and functional dependency on healthcare consumption, quality of     life, functional ability and experiences of care.   "
111365|NCT01828255|"     The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time     and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be     recorded continuously over 24 hours with SENSIMED Triggerfish®, a portable investigational     device using a contact lens sensor. After completing the Triggerfish lens placement and     removal; the patient will complete a formal Polysomnography.   "
111264|NCT01829581|"     Intracerebral hemorrhage [ICH] is the most feared complication of anticoagulant therapy     [OAC]. Evidence regarding acute therapeutic interventions as well as secondary treatment     approaches is still limited. Therefore, this German-wide observational cohort study will     retrospectively identify and evaluate all OAC-associated ICH patients that have been admitted     to the 20 participating tertiary centres over a 5-year period. The main focus of this     investigation, besides epidemiological aspects, will be the (i) acute management of OAC-ICH,     (ii) secondary therapy (anticoagulant management) and (iii) long-term outcome after OAC-ICH.   "
111265|NCT01829568|"     This phase I clinical trial studies the side effects and best dose of lenalidomide and     ibrutinib when given together with rituximab in treating patients with previously untreated     stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different     ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     rituximab, can find cancer cells and help kill them. Giving lenalidomide and ibrutinib     together with rituximab may work well in treating follicular lymphoma.   "
111400|NCT01827800|"     This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention     that includes interactive self-monitoring and feedback, tailored skills training materials,     telephone counseling calls, and primary care physician (PCP) counseling will produce greater     weight change at 12 months than a standard primary care control.   "
111266|NCT01829555|"     Glucose control is necessary to avoid the immediate and long-term adverse effects associated     with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important     step to achieving glucose control. Data suggest that large proportions of adolescents and     young adults fail to adhere to standard guidelines of self-monitored of blood glucose testing     and have hemoglobin A1c levels >7.5%. A finite period of poor metabolic control can lead to     increased risk of medical complications over an individual's lifespan, necessitating novel     interventions to improve self-monitored blood glucose testing and metabolic control in     emerging adults with type 1 diabetes. The investigators treatment approach, which provides     direct tangible reinforcement for objective evidence of behavior change, is efficacious in     decreasing substance use, reducing weight, and improving medication adherence.      The purpose of this project is to develop and pilot test an intervention based on behavioral     economic principles for improving self-monitored blood glucose testing in young persons with     type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they     test, and a return text will inform them of reinforcer vouchers earned. The investigators     will collect data on self-monitored blood glucose testing frequency and A1c levels preceding     treatment initiation and throughout a 6 month treatment period. If promising, a randomized     trial will lead to larger scale evaluations of reinforcement interventions alone, or in     combination with multimodal treatment approaches, and it may be applied to other clinical     issues such as adherence to continuous glucose monitoring. Importantly, this intervention can     be administered remotely and in an automated fashion, allowing for widespread adoption if     efficacious.   "
111267|NCT01829542|"     The purpose of this study is to assess the impact of acute blueberry polyphenol intake on     endothelial function of healthy volunteers. Specifically, the investigators plan to perform a     randomised, double blind, cross-over human intervention trial using a blueberry drink to     investigate the dose-dependent effects of blueberry polyphenols on blood vessel function     using Flow mediated dilation (FMD) to measure endothelial function. The study will not only     measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess     plasma polyphenol metabolite levels.   "
111268|NCT01829529|"     The hypothesis of the present study is that quantitative and qualitative oral microflora     alterations and changes in antibiotic susceptibility among oral commensal microflora will     occur following a single dose administration of amoxicillin.   "
111269|NCT01829516|"     This is a randomized, placebo controlled, double blind crossover study of the effects of     intranasal oxytocin on social cognition, implicit preferences and craving in moderate to     heavy social alcohol drinkers.   "
111270|NCT01829503|"     Primary objective: To determine the efficacy of an induction regimen using decitabine as an     epigenetic primer followed by cytarabine in the treatment of older patients with newly     diagnosed Acute myeloid leukemia (AML).      Primary endpoint:      Complete remission rates      Secondary objective: To determine the safety of an induction regimen of decitabine followed     by cytarabine in the treatment of older patients with newly diagnosed AML, evaluate survival     and identify potential predictive factors for response to treatment      Secondary endpoints:        -  Treatment related toxicities        -  4 and 8 week mortality        -  Overall survival        -  Relapse-free survival        -  Predictive factors for response to treatment        -  Quality of Life measures including self reported symptoms and assessment of sleep          patterns      Treatment administration      Induction therapy Eligible patients will be treated with induction therapy (decitabine +     cytarabine) at the University of Pittsburgh Cancer Center inpatient leukemia service at     Shadyside Hospital. Patients will receive decitabine 20mg/m2 in 100mL normal saline (NS)     intravenously (IV) over 1 hour daily for five days, followed by cytarabine 100mg/m2 in 1000     mL normal saline (NS) as a continuous IV infusion over 24 hours for 5 days. Treatment should     be discontinued or delayed for any of the following during the treatment period: a rise in     serum creatinine > 2x patient baseline or upper limit of normal (whichever is higher) unless     there is an identifiable reversible etiology, or ALT, AST or total bilirubin > 5x upper limit     of normal, and should be held until resolution below these parameters. There are no     parameters for dose reduction.      Patients who have persistent disease on post-treatment bone marrow aspirate and biopsy, will     undergo a repeat cycle of induction with decitabine followed by cytarabine as outlined above.      Supportive care including blood product transfusions, antiemetic medications antiviral and     antifungal medications, or empiric antibiotics may be used at the clinical discretion of the     provider.      Maintenance therapy Patients in complete response (CR) will proceed to decitabine maintenance     therapy, where each treatment will be decitabine 20mg/m2 in 100mL normal saline (NS)     intravenously (IV) over 1 hour daily for five days administered in the outpatient setting.     Maintenance treatments will be continued until disease relapse. Maintenance treatments can be     administered as an outpatient at the Hillman Cancer Center, or at a University of Pittsburgh     Medical Center (UPMC) facility that is able to administer chemotherapy under the supervision     of an Oncologist      Evaluations during maintenance Phase:      During maintenance therapy, complete blood count (CBC) w/ diff/platelets, CMP (Na, K, Cl,     carbon dioxide (CO2), glucose, blood urea nitrogen (BUN), Cr, Ca, Total Protein, Albumin,     AST, ALT, Alk Phos, Total Bilirubin) will be checked each cycle on day 14 [+/- 4 days].      Within 7 days of start of new cycle, study visits will include physical exam, adverse events     assessment, CBC and comprehensive metabolic panel (CMP).      Maintenance cycles will be 28 days [+/- 7 days]. Cycles can be held up to 4 weeks [28 days].     For start of new cycle, any grade 3 or 4 non-hematologic toxicity possibly, probably or     definitely related to decitabine therapy must resolve to grade 2 or baseline.      In addition the following lab parameters must be met to start a new cycle of maintenance:      Absolute Neutrophil Count (ANC) > or = 1000/mm3 Platelets >/= 50,000/mm3 AST or ALT < 2 x     Uppler Limit of Normal (ULN) Total billirubin < 2 x ULN Serum creatinine < 2x patient     baseline or upper limit of normal (whichever is higher)      [If lab parameters are not met for start of cycle, these labs will be checked a minimum of     once per week]. If start of new cycle is held for more than 4 weeks [28 days], the subject     will be off treatment.      Other reasons for delay in treatment should be discussed with the Principal Investigator.   "
111271|NCT01829490|"     This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A     vaccination with and without MVA85A boost in healthy BCG vaccinated adults.   "
111272|NCT01829477|"     The purpose of this study is to evaluate the effect of TAK-875 compared to placebo on     glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in     addition to diet and exercise.   "
111273|NCT01829464|"     The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination     with sitagliptin on glycemic control in adults with type 2 diabetes.   "
111274|NCT01829451|"     The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion     formation after endometrial thermal ablation.   "
111275|NCT01829438|"     To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred)     on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen     saturation) in healthy children.   "
111276|NCT01829425|"     This study is randomized controlled trial in which urgency incontinent women (approximately     150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6     &12; a subset of women will have pre-treatment brain activation and connectivity compared to     controls using functional magnetic imaging (fMRI) with 2 month post-treatment brain     activation and connectivity compared to pre-treatment in the UUI subset using fMRI.      Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy decreases     abnormal perception of bladder distension outside the hypnotic state and is at least as     effective as pharmacotherapy in diminishing symptoms of urgency and severity of UUI. On fMRI     in UUI, hypnotherapy will decrease hyper-activation of brain areas in response to bladder     distension and/or modulate functional connectivity within the brain. Normalization of     hyper-activation and connectivity will be greater in hypnotherapy compared to     pharmacotherapy. Additionally, women who have greater improvement in UUI will have greater     normalization of hyper-activation and connectivity on fMRI. UUI participants will exhibit     increased activation within portions of the brain and abnormal functional connectivity     relative to controls.   "
111322|NCT01828827|"     This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment,     two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the     pharmacokinetics of PA-824. This study was designed to understand the possible effects of a     high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be     tested in this study is that the rate and extent of absorption of PA-824, as measured by     Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as     compared with after a minimum 10-hour fast.   "
111277|NCT01829412|"     Bone disease in multiple myeloma (MM) is routinely assessed by skeletal X-ray (XR) and     magnetic resonance of the spine (S-MRI). Diffusion-weighted MRI (DW-MRI) is a functional MRI     that detects water diffusion through cells. This prospective phase II study compared     whole-body DW-MRI with XR and S-MRI for the assessment of MM bone lesions.      METHODS. Thirty-six consecutive symptomatic patients at diagnosis or at relapse performed XR,     S-MRI, whole-body MRI, and whole-body DW-MRI before treatment, after treatment, and 6 months     after treatment. A substudy evaluated 12 asymptomatic patients at diagnosis, after 6 and 12     months. Radiology exams were independently read by 3 experienced radiologists, and the     techniques were compared by the count of segments with focal lesions (FL) (>=5mm).   "
111837|NCT01822080|"     This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the     treatment of endometriosis.      There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group     phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks     for all subjects who completed the double-blind phase, irrespective of their treatment     assignment in the first study phase.   "
111278|NCT01829399|"     Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq) pain     from an upper arm Tq can limit the ability to use regional anesthesia as the primary     anesthetic for surgical procedures on the upper extremity. The aim of this study is to     determine whether a subcutaneous ring of local anesthetic on the inner aspect of the upper     arm just distal to axillary crease will significantly diminish Tq pain. If it does,     peripheral nerve blocks distal to the Tq (i.e., nerve blocks at the elbow) could be used as     the primary anesthetic for surgery of the hand and forearm. These distal peripheral nerve     blocks have fewer complications than brachial plexus blocks performed at higher levels, and,     postoperatively, the patient has better control of his or her arm when distal nerve blocks     are used.      Procedures (methods): This is a prospective, cross-over study to examine the effectiveness of     an upper arm Subcutaneous ring of local anesthetic alone in relieving Tq pain. This     Subcutaneous ring of local anesthetic is often referred to as Intercostobrachial nerve     block or Subcutaneous ring anesthesia (SRA). Twenty volunteers will be randomized into     four groups of 5 participants each. During the initial experiment, the first group will be     given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their dominant     arm, the second group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine     1:200,000 on their non-dominant arm, the third group will be given sham SRA with saline on     their dominant arm, and the fourth group will be given sham SRA with saline on their     non-dominant arm. 15 minutes after SRA, a Tq will be applied to the arm with the subcutaneous     injection and it will be inflated to 100 mm Hg above the subject's baseline systolic blood     pressure. We will monitor heart rate, blood pressure (opposite arm) and pain (0 to 10 VAS)     every 5 minutes. Each Tq will be released when the subject requests deflation or when 1 hour     of Tq time has elapsed, whichever occurs first. The subject's discomfort level (VAS) just     prior to deflation will be recorded. Since Tq pressure alone can inhibit nerve function, we     will monitor motor and sensory function distal to the Tq every 10 minutes during Tq inflation     and for 30 minutes after Tq deflation. One to two weeks after this initial study, the same 20     subjects will receive SRA on the same arm and the same parameters will be measured. The 10     subjects who received 0.25% Bupivacaine the first time will receive Normal Saline, and the 10     subjects who received Normal Saline the first time will receive 0.25% Bupivacaine. In this     way, each subject will act as his or her own control.   "
111279|NCT01829386|"     This study will determine if MRI imaging can be used to estimate the amount of iron in areas     of the brain affected by a stroke. This may help future patients if the scan can be used to     predict the amount of brain damage and therefore the effects on the patient.      New research treatments are being used to reduce the amount of iron build-up in the brain.     The effects of that treatment may also be estimated using new MRI techniques.   "
111280|NCT01829373|"     This study tests the ability of the allogeneic cellular vaccine 1650-G vaccine to enhance     immune recognition of tumor cells in patients with lung cancer. The vaccine is combined with     an oral medication called beta glucan, an over the counter oral dietary supplement that may     also stimulate the immune system in ways that helps the body eradicate cancer cells and     reduce risk of recurrent cancer. The primary purpose of this study is to measure the changes     in the number of immune cells that might help lower risk of cancer recurrence. The     investigators do not yet know if the vaccine is effective in fighting cancer and will not     know at the end of this study whether this has been of benefit.   "
111281|NCT01829360|"     This research attempts to adapt and optimize a word learning treatment, specifically     interactive book reading, for use with Kindergarten children with Specific Language     Impairment (SLI). Children with SLI have difficulty learning language without any obvious     cause for this difficulty. Two treatment studies will be conducted to determine (1) the     number of times children with SLI need to hear new words during book reading to learn the new     words; (2) the best way to provide the target number of exposures to new words during book     reading. For example, is it better to hear the new words many times within the book and to     read the book few times, or is it better to hear the new words a few times within the book     and to read the book many times. The investigators hypothesize that children with SLI will     need to hear new words 2 to 3 times as often as children with normal language to learn the     words and that reading the books many times will be more effective than repeating the words     many times within a book.   "
111282|NCT01829347|"     The purpose of this study is to determine if treatment with the ELAD System is safe and     effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille     score >0.45).   "
111283|NCT01829334|"     The aim of this proposed study is to investigate the cost-effectiveness of four methods in     preventing fissure caries in permanent teeth, which is the most prevalent dental disease in     primary school children in China.      The four caries prevention methods are: resin fissure sealant, atraumatic restorative     treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.      The specific study objectives are:        1. to describe longitudinally the clinical outcomes of using the above four methods to          prevent dental caries in the pits and fissures of permanent first molars in school          children,        2. to describe the cost of using the above four methods to prevent dental caries in an          outreaching dental care programme in China, and        3. to compare the cost-effectiveness of the above four caries prevention methods.   "
111284|NCT01829321|"     -  Approximately 45 patients suffering from mild to moderate ulcerative colitis will be          examined for any side effects (safety and tolerability) that may occur when taking          GLPG0974 or matching placebo (2:1 ratio) for 28 days.        -  During the course of the study, patients will also be evaluated for improvement of          disease activity by different efficacy measures, the amount of GLPG0974 present in the          blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the          blood, colon biopsies and faeces will be explored.   "
111285|NCT01829308|"     The purpose of this study is to examine the implementation of two evidence-based intervention     strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug     use, and HIV risk behaviors.   "
111286|NCT01829295|"     In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the     investigators propose to establish which immunosuppressive therapy, methotrexate or     mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for     the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative     effectiveness trial.   "
111377|NCT01828099|"     The primary purpose of the study is to compare the antitumor activity of LDK378 versus     reference chemotherapy.   "
111366|NCT01828242|"     Life style changes, particularly in dietary patterns have contributed a great deal to the     incidence and risks of type 2 Diabetes. Decreased intakes of vegetables and fruits replaced     by pre processed food, added sugar and those of animal origin lead towards rapid increase of     adult-onset-diabetes.      In spite of the knowledge of the benefit of consuming vegetable and fruits, and people are     well informed, they still need to be committed to perform a behavior and implement these     intention. Behavioral approach methods have demonstrated successful adherence in health     education with life style changes.      Objective: To identify the impact of The Empowerment Model to enhance vegetable intake in     Type 2 Diabetes Mellitus adults in achieving glycemic control.   "
119666|NCT01719575|"     The purpose of this study is to compare the effects of Motilitone and placebo on gastric     volumes, gastric emptying, small bowel transit and colon transit in female and male healthy     volunteers.   "
111287|NCT01829282|"     This study focuses on the implementation of an evidence-based HIV risk reduction intervention     for HIV-serodiscordant, heterosexual African American couples (Eban II) in two geographic     areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that     have a high prevalence of HIV infection and risk conditions among African Americans.      The Specific Aims are as follows:        1. To evaluate implementation of Eban for HIV serodiscordant African American couples in 10          CBOs in California. To do this, we will document the implementation process and identify          barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200          staff at CBOs to obtain this information.        2. To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples,          specifically incidents of protected sex, proportion of condom use, and incident sexually          transmitted infections. Eban will be assessed using a randomized delayed enrollment          (waitlist) control design to evaluate the impact of treatment on outcomes at posttest          and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to          couples and evaluated for effectiveness - that is, how well it works in the real world.)        3. To determine the cost-effectiveness of implementation of Eban, based on implementation          costs and potential cost savings.   "
111288|NCT01829269|"     The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years     and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher     complication rate than average. We will therefore be increasingly confronted with faulty     sensors or at risk to be replaced.      There are no standardized approach for replacing defibrillation lead. A record made in the     United States showed significant differences according to the teams strategy in case of     failure of defibrillation lead in particular with regard to the decision to explant or     abandon the probe.      The risk of extracting a defibrillation lead are well known with a major complication rate of     1.6 to 1.95%.      Regarding the risk of complications related to the abandonment of a probe we have less data.     For some there is no risk to abandon a defibrillation lead. But others reported a     complication rate of 5.5% related to pacing discontinued.      Main objective: Collect the attitude of different centers and different operators when     replacing a failed defibrillation lead or at risk. Explantation or abandonment of the     sensor replaced.   "
111289|NCT01829256|"     Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and     death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United     States. The purpose of this study is to prevent progression of kidney disease among patients     with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that     simultaneously address medication management and modifies multiple risk factors through a     combination of patient self-monitoring, behavioral therapies and education to optimize     adherence and self-efficacy. Additional goals are to improve control of cardiovascular     disease risk factors and reduce cardiovascular events and death.      We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention will     have less progression, or a smaller decrease in kidney function, after 3 years when compared     to the education control group.   "
111290|NCT01829243|"     This study was designed to investigate whether milnacipran is safe and effective in improving     cognitive function in fibromyalgia. In addition, this study was aimed to investigate whether     improvement in neurocognitive status due to milnacipran correlates with improvements in pain,     to investigate whether improvement in neurocognitive status due to milnacipran correlates     with improvements in fatigue, and to determine whether treatment with improvement in     neurocognitive status, pain and fatigue correlates with functional improvement.   "
111291|NCT01829230|"     This is a continuation study for subjects who were previously fit with test or control     lenses; all will stop wearing their study lenses assigned in the previous study and will     start to wear an FDA-approved marketed spherical soft contact lens.   "
111292|NCT01829217|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the drug is being studied. It also means that the FDA has not     yet approved sunitinib for your type of cancer.      Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors,     advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most     chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking     certain protein signals within the cell. Because sunitinib works differently from standard     intravenous chemotherapies, we call it a targeted therapy. This drug has also been used in     other research studies and information from those other research studies suggests that this     agent may help to slow the growth of some NSCLC tumors.      In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors from     growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously been     found to be more sensitive to other kinds of oral targeted therapies. This study will focus     specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known cancer gene     (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100 cigarettes in     their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET gene.   "
111293|NCT01829204|"     The purpose of this study is to identify and elucidate the pattern and perhaps role of     atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms     involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and     preterm labor.   "
111294|NCT01829191|"     This study is to investigate whether novel soft contact lens optical designs can slow myopia     progression   "
111323|NCT01828814|"     Options for large-scale preventive distributions include fortified blended flours,     ready-to-use foods and direct cash transfer either alone or in combination with family     protective rations. Finding the most appropriate strategy is essential to prevent child     malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare     different preventive strategies on the incidence of acute malnutrition among children 6 to 23     months.   "
111324|NCT01828801|"     The purpose of this clinical study is to evaluate blood metal ion levels as a function of     time of implantation for the Pinnacle Acetabular MoM system.   "
111378|NCT01828086|"     A randomized, double-blind, placebo and positive controlled, single and multiple dose study     to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in     chronic plaque-type psoriasis patients.   "
111295|NCT01829178|"     Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid     tumours. acute renal failure, despite conservative fluid and electrolyte management,     frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan     complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective,     anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated     lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to     cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor,     vascular endothelial growth factor and insulin-like growth factor-I have shown in the     previous in-vitro studies.The aim of present study,a randomized double-blind placebo-     controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin     induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed     upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus     chemotherapy [cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21     days] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and urine     electrolyte will be measured daily during chemotherapy.      changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity     assessed up to 64 days.   "
111296|NCT01829165|"     The overarching goal of this research program is to elucidate causal and directional neural     network- level abnormalities in depression, and how they are modulated by an     individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the     investigators can overcome a major limitation of neuroimaging - the inability to demonstrate     causality. The investigators' findings will serve as a platform for future studies wherein     TMS treatment can be directly guided by the investigators' ability to image and causally     manipulate specific neural networks.      Aim 1: To examine causal interactions between two major brain networks in depression.      Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in     depression.      Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls,     in two targeted and interacting networks, using concurrent transcranial magnetic stimulation     (TMS) and functional magnetic resonance imaging (fMRI).      Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in     normalization of baseline network-level deficits, and be predicted by degree of baseline     network abnormalities.   "
111297|NCT01829152|"     The primary objective is to evaluate the impact on heart failure related quality of life when     integrating a mobile health system, Verizon Wireless's Converged Health Management (CHM),     into a subject's self-management of their heart failure (HF) as well as in the medical     management of HF by the subjects' clinical team.   "
111298|NCT01829139|"     In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones,     there is no definite guideline for the management of remnant acalculous gallbladder. This     study was planned to evaluate the efficacy of choleretic agents in those patients comparing     with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So     that, the investigators want to establish the treatment guideline in gallbladder in situ     without definite stones following complete removal of CBD stones. Second, the protective or     preventive effect of choleretics may be defined.   "
111299|NCT01829126|"     Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the     skin and all internal organs. Cardiac involvement, mainly characterised by small     intramyocardial coronary artery involvement and myocardial fibrosis, can cause the     development of impaired diastolic ventricular filling, cardiac blocks and ventricular     arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug     has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based     level. Short-term trials and retrospective studies have suggested a favourable and protective     effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients     with myocardial involvement. However, no data are presently available on the prevention and     treatment of severe heart disease.      This observational trial is part of the collaborative project DeSScipher, one out of five     observational trials to decipher the optimal management of systemic sclerosis. Aim of this     observational trial is to assess the efficacy and safety of calcium channel blockers and     angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac     involvement.   "
111300|NCT01829113|"     This randomized phase II study will compare the efficacy and safety of the combination of     carboplatin and pemetrexed with and without OGX-427 in patients with previously untreated     advanced non-squamous NSCLC.   "
111301|NCT01829100|"     Psychological therapies for depression have demonstrated efficacy, but outcomes are still     unsatisfactory, especially in cases with high comorbidity. Depression and anxiety co-occur in     up to 69-75% of teens and intensify functional impairment and service use. This study will     develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy (GBAT)     and conduct a pilot waitlist-controlled school-based study with 35 7th and 8th grade boys and     girls with co-occurring depression and anxiety. Multi-reporter, multi-domain assessments will     be conducted at initial screening, pre- and post-treatment, and 4-month follow-up. BA is a     straightforward, but flexible and robust, therapy that has demonstrated strong results in     adults. Current formulations of BA highlight the specific role of avoidance in depressotypic     behavior. It presumes that anhedonia, isolation, and negative behaviors associated with     depression function to avoid imminent distress even as it blocks access to otherwise     available positive reinforcement. This study will therefore employ novel electronic diary     technology to obtain Ecological Momentary Assessment and evaluate: (a) the function of     avoidance in distinguishing youth with depression (n=35) from a non-clinical comparison group     (n=18), and (b) the role of avoidance in mediating treatment gains in participants in the     GBAT intervention.   "
111302|NCT01829087|"     The goal of this research project is to evaluate injections of botulinum toxin A (Botox) as     the treatment for knee flexion contracture after total knee arthroplasty (TKA). The current     treatment for patients who do not achieve full extension of the knee (flexion contracture)     after TKA consists of an aggressive physical therapy program, home stretching program, and     the use of an extension orthosis (brace). Many patients do not tolerate wearing these braces.     This initial project is designed to use injections of Botox as an adjunct to the standard     current treatment and evaluate its efficacy. It is our hypothesis that a single injection     into the hamstrings in addition to routine postoperative rehabilitation will result in     improved knee extension and this improvement in function should endure without further     treatment.   "
111303|NCT01829074|"     Acid reflux can cause many symptoms in the throat, including discomfort or pain, and     difficulty with breathing and voice problems. Doctors have different ways of diagnosing and     treating the reflux that causes these symptoms, and they are trying to better understand what     the best ways are to treat the patients with these symptoms.      Usually, a doctor will prescribe medication for reflux based on the symptoms a patient     complains of. Sometimes it works and the patient gets better, sometimes it does not work and     the patient's condition does not improve. The doctor will also use findings from an     examination with an endoscope in the patient's throat to see if there is any damage that     might have been caused by reflux. One new device that doctors use to help them diagnose     reflux has a sensor on the end of a tube that goes through the nose and rests in the throat.     This sensor measures the acid reflux for 24 hours, showing the doctor when acid reflux     occurs.      The study doctors are performing this research study to help them understand more about acid     reflux disease, and the best ways to diagnose and treat their patients who have acid reflux.      The study involves procedures, medications and devices that are already used regularly in     doctors' offices and hospitals. The experimental part of this research is blinding the study     doctor to the results of the pH study until the end of a three month course of antireflux     medication, and performing a second pH study to measure change in acid exposure.      Hypothesis: The Restech pH study helps identify patients who will respond positively to acid     inhibitory therapy, and patients whose study normalizes will have better Symptomatic response     rates than those whose pH levels fail to normalize.   "
111304|NCT01829061|"     The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the     in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained     from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is     indicated in the management and treatment of diabetes and for monitoring long term glycemic     control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing     devices should be used with this system.   "
111305|NCT01829048|"     To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally     to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/-     other adjunctive medication.   "
111306|NCT01829035|"     This is a randomized, multi-center, open-labeled, phase III study in patients with advanced     HCC. A total of 338 patients will be randomized (1:1) into one of the two treatment arms, to     receive sorafenib with (Arm Combination-treatment; Arm C) or without (Arm Sorafenib alone     treatment; Arm S) cTACE.      All the patients will be initially given sorafenib within 72 hours after the randomization.     Treatment should continue until the criteria for treatment discontinuation are met.      After the treatment period, patients will undergo follow up for survival every 12 weeks (±7     days) from the last dose, and the survival follow up will be performed for at least 1.5 years     after the last patient's last treatment.   "
111307|NCT01829022|"     Primary objectives : To investigate technical feasibility and postoperative morbidity after     E-NOTES for Myomectomy with Traction of Multidirectional Sutures      Secondary objectives : To investigate postoperative pain after E-NOTES for Myomectomy with     Traction of Multidirectional Sutures by clinical variables such as incision size, type of     port, size and number of myoma, or operation time.   "
111308|NCT01829009|"     Aging is characterized by a progressive loss of multiple physical and cognitive abilities.     From these changes, the most important one is the loss of muscle mass, which has been called     sarcopenia. Resistance exercise is a therapeutic approach for sarcopenia, nevertheless     there is no universal consensus. Therefore, this research is interested in determining the     effect of a resistance exercise program on physical performance and/or functional status in     sarcopenic older women. The main study hypothesis is that a program of resistance exercise     will improve physical performance and functional status in sarcopenic older women compared     against general recommendations.      This is a single-blind, controlled clinical trial, including women> 70 years, living in the     community with sarcopenia. Those who agree to participate, will be randomly assigned to one     of the following groups:        1. Resistance Exercise Group        2. General Recommendations Group (control) The study will last 24 weeks, with 4          measurements performed at baseline, week 6, 12 and 24. Multilevel models (random          effects) will be constructed for the comparison between the two groups. Tests will be          conducted with a P=0.05 and confidence intervals at 95%. This protocol has been approved          by the local ethics committee.   "
111309|NCT01828996|"     Chronic prostatitis/chronic pelvic pain syndrome is an extremely common urologic diagnosis     and accounts for approximately 2 million outpatient visits to urology practices in the United     States alone. Up to 6% of men in Canada recently experienced at least moderate to severe     prostatitis-like symptoms with two thirds having symptoms lasting more than one year. There     are a myriad of therapies for prostatitis, some of which work on some of the men but none     works for all the men. Recently, a number of centres have been using low energy shock waves     applied on the skin to target the prostate and the muscles around the prostate. The initial     reports showed a significant reduction in the pain experienced by the men with prostatitis.     However, this potentially highly promising therapy has not been widely used at least in part     due to a lack of properly designed studies to validate this therapy. The investigators plan a     randomized control trial using shock wave therapy on men with prostatitis. The goal is to     provide some solid evidence that either shock waves are or are not of clinical benefit.      The investigators hypothesize men with chronic prostatitis/ chronic pelvic pain syndrome will     have a reduction in pain and improved voiding and sexual function following low power     transdermal shock wave therapy to the prostate and surrounding pelvic muscles.   "
111325|NCT01828788|"     Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In     cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's     capacity of coughing, deep breathing, and early mobilisation. It may be responsible for     respiratory complications such as bronchial or pulmonary infection, and may also delay the     patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous     pilot study performed in our department showed a sensible improvement of analgesia at     movement and of rehabilitation with a continuous bilaterosternal infusion of local     anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested     in a subpopulation of patients at risk for respiratory complication.   "
111310|NCT01828983|"     Deployment impacts both service member and family, and the cost can be high. Spouses'     reactions to deployment may include emotional distress, loneliness, anticipatory fear or     grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage     stress and solve problems related to deployment and reintegration, communication, managing     long distance relationships, and other common problems. The study will compare telephone     support groups to online education sessions. The study will enroll 160 spouses. In the     Telephone Support groups, a group leader and participants will meet 12 times over six months     to focus on education, skills building and support. Education Only online sessions will     provide the same education content, without skills building or support. Content includes     strategies to reduce or eliminate communication difficulties during deployment, how to find     help; practical concerns during deployment; fostering resilience and decreasing stress;     fostering relationships while apart, negotiating roles and relationships; changes during     deployment; strategies to support the spouse and the service member; and cues to alert     spouses when to seek mental health services for the family or themselves. Outcomes will     include resilience, depression, anxiety and coping behaviors. Telephone data collection will     be conducted at baseline, six and twelve months.   "
111311|NCT01828970|"     The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin     regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed     patients with diabetes   "
111312|NCT01828957|"     The objective of this study is to evaluate the efficacy and safety of a single intratracheal     administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk     premature infants by comparing Pneumostem-treated group with a control group.   "
111313|NCT01828944|"     The present project hypothesizes that the potential protective effect of olive oil relies on     its polyphenols profile (quality and quantity) and that it may be synergistic to other food     components. Among the nutrients that may be of interest for bone and muscle tissues,     unsaturated fatty acids and vitamins are the most described.      Consequently, based on the promising available preliminary data, the present project aims to     investigate the possible preventive effect of olive oil polyphenols and eventually the     synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order     to prevent any locomotor dysfunction.      Volunteers will be supplemented during 9 months. The primary and secondary outcome measures     will be performed at baseline, 3 and 9 months.   "
111314|NCT01828931|"     The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with     psychotic illnesses than in the general population. Life expectancy of individuals with     psychosis is also 20-25 years less than the general population, primarily due to premature     onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic     illness has been an exclusion criterion in all large-scale studies of diabetes prevention and     management. We propose a 3-year randomized controlled trial examining the effectiveness of a     lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity     in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM.     Weight and glycemic control will be the primary outcome variables. It is hypothesized that a     significant weight reduction and improvement in glycemic control will be found in those who     receive the LI relative to those who do not.   "
111315|NCT01828918|"     Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients     takes potential diagnostics, prognostics, and applications into consideration, especially the     molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic     targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic     therapy are the most important future clinical applications. CTCs measures may be useful to     guide change in treatment decisions.   "
111316|NCT01828905|"     The aim of the study is to compare fracture healing, quality of life, pain, and cost of care     of the use of CERAMENT™|BONE VOID FILLER as bone graft substitute to the use of autologous     cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated     by internal fixation and void reconstruction.   "
111317|NCT01828892|"     Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of     low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to     compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG),     commercial fibrin glue, and control therapy in the management of patients with low-output     volume ECFs.   "
111318|NCT01828879|"     The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in     treating the signs and symptoms of moderate (medium level of seriousness) to severe (very     serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic     [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease     with a genetic predisposition [latent susceptibility to disease at the genetic level]) in     adult participants.   "
111319|NCT01828866|"     One interesting approach to the treatment of addiction is the use of Eye Movement     Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the feasibility     and efficacy of EMDR on addiction is limited and often lacks methodological rigor, the     results are promising and suggest that further research on this subject is warranted.      This proposal consists of two studies to test and determine the acceptability, feasibility     and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol     dependent outpatients as well as to gain further understanding in underlying working     mechanisms.   "
111320|NCT01828853|"     This study aim to estimate maternal and neonatal outcomes after membrane sweeping in     different group of patients.   "
111321|NCT01828840|"     The current study aim is to compare between the opioids morphine, fentanyl and methadone in     terms of efficacy and side effects profile when administered epidurally for pain management     after laparotomies. Intravenous morphine will also be used. The outcomes of that method will     be compared to those obtained using epidurally administered opioids, as this is another     commonly used postoperative pain relief method.   "
111326|NCT01828775|"     This pilot randomized clinical trial studies palliative care intervention in improving     quality of life, psychological distress, and communication in patients with solid tumors     receiving treatment on phase I trials. Cancer patients experience many symptoms related to     treatment and the cancer itself that can be distressing and impact quality of life.     Palliative care focuses on managing these symptoms and may help patients with solid tumors     live more comfortably.   "
111328|NCT01828749|"     Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the     last decade. However, the observed increases failed to reduce mortality or missed injury     rates. Several investigators have derived (citation) and validated (citation) clinical     decision rules that attempt to identify a subset of low risk pediatric and adult patients in     whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to     significantly reduce utilization. The investigators propose an alternative and complimentary     strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the     abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence     of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies     clinically significant intra-abdominal injury (cs-IAI) as accurately as routine     abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically     important decrease in radiation exposure. The study will investigate this by comparing the     accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect     cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two     age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically     indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study     will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis     imaging for the identification of cs-IAI. The reference standard will include initial     radiology reports, with structured follow up of indeterminate scans, operative reports, and     7-day medical record review.   "
111329|NCT01828736|"     A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of     association of trastuzumab with combination chemotherapy in advanced or metastatic bladder     cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may     improve treatment efficacy on tumours overexpressed HER 2.   "
111330|NCT01828723|"     The primary purpose of this study is to demonstrate the safety of injecting the Stromal     Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts     into regions of the face that require enhancement. The safety of SVF will be evaluated     throughout the course of the study phase through the assessment of laboratory values,     physical examinations, adverse events, safety phone calls etc.   "
111331|NCT01828710|"     Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction.     Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher     than in serum, and interestingly it was increasing through the epididymis and the deferent     duct mining that sperm cell before ejaculation are stored in a medium highly enriched in     myo-inositol.      Starting from this evidences, the investigators hypothesized that myo-inositol may be a     possible factor able to improve the semen parameters of samples used in in vitro     fertilization cycles.   "
111332|NCT01828697|"     This is a randomized-controlled open-label trial comparing two different doses of     low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous     thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the     American College of Chest Physicians (ACCP), but it is not known which dose is more     efficacious in preventing recurrent venous thromboembolism in pregnancy.      Patients enter the study and will be randomized as soon as a home test confirms pregnancy.     LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months     postpartum. Patients will be recruited by their treating physician, either an obstetrician or     internist.   "
111333|NCT01828684|"     Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine     sufferers report light sensitivity during a headache. Some people with migraine report that     light can trigger their migraines and some people with migraine are light sensitive all of     the time. The investigators have recently determined that certain colors of light are more     likely to trigger migraines than other colors. In this study the investigators want to know     if people who wear glasses that block these colors of light will have fewer migraine     headaches.   "
111334|NCT01828671|"     Tortillas are a staple food in several cultures and are widely used to make tacos, burritos,     and enchiladas. These foods are gaining a significant segment of the North American fast food     and restaurant industry. From a health point of view, the addition of soy flour into corn     tortillas will improve the nutritional profile of the tortillas and the presence of soy     protein, dietary fibre and bioactive components has the potential to yield other health     benefits. It is hypothesized that the addition of soy flour to corn tortillas will lower the     glycemic index which could benefit those individuals with type 2 diabetes.      The purpose of this research is to investigate whether different levels of soy flour in corn     tortillas influences the glycemic response.   "
111335|NCT01828658|"     The investigators developed a prospective, randomized, controlled trial to compare strict     volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus     traditional clinical volume control in hemodialysis patients and the impact on mortality,     hydration status, blood pressure values and arterial stiffness.   "
111336|NCT01828645|"     Carbohydrate enriched-drinks has been used as preoperative treatment up to two hours before     anesthesia. These drinks are safe and are not associated to bronchial aspiration during     anesthesia. The addition of protein may be beneficial for metabolic preconditioning but there     is a few data in literature testing these drinks for safety. The aim of the study will be to     investigate the residual gastric volume (RGV) measured during the gastroscopy with     abbreviation of fast to 2h with a carbohydrate plus whey protein enriched-drink.   "
111362|NCT01828294|"     The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive     acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients     may or may not be receiving anticholinesterase agents. A common treatment for patients with     this disease includes the administration of intravenous immunoglobulin (IVIG), which is a     plasma protein that is given to help maintain adequate antibody levels to prevent infections     and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to     test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and     thighs) will be better tolerated for patients with Myasthenia Gravis.   "
111363|NCT01828281|"     We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and     increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and     liver fat, plasma lipids, carotid artery thickness.   "
111337|NCT01828632|"     Background. Morbidly obese patients show an increased risk of hypoxemia and a higher     incidence of postoperative pulmonary complications during the postoperative period resulting     in prolonged hospital length of stay when compared with normal weight subjects. Preoperative     respiratory physiotherapy including inspiratory muscle training (IMT) has been shown to     reduce the incidence of post operative respiratory complications in some different settings.      Objective. To determine wether a program of preoperative respiratory physical therapy could     reduce the incidence and severity of postoperative hypoxemia in morbidly obese patients     undergoing laparoscopic bariatric surgery.      Setting. Hospital Clínico Universitario, Valencia, Spain.      Design and Patients. A double-blind, randomized clinical trial. 50 patients (BMI≥40%)     consecutively scheduled for laparoscopic bariatric surgery were included of whom 44 completed     the study. Sample size was calculated using the repeated measures of the PaO2/FiO2 ratio     along the postoperative period as the primary endpoint and considering an effect size of     0.25.      Interventions. Patients were randomly assigned to receive either preoperative respiratory     physical therapy (n=23) or usual care (n=21) during a month just before the date of surgery.     Both groups received the same postoperative physical therapy.      Measures. Data on oxygenation (primary outcome, PaO2/Fio2 ratio) were obtained at 1hour and     at 12 hours after surgery. Data on spirometry and maximum static respiratory pressures     (secondary outcomes) were obtained before and after the training period, and in the     postoperative period.   "
111338|NCT01828619|"     The purpose of this study is to determine whether the new RIC regimen, containing of low dose     of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged     and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem     cell transplantation.   "
111339|NCT01828606|"     Although there is no doubt about the need for compression therapy in lymphoedema, it is not     investigated in much detail how much pressure is needed to get optimum volume reduction. New     research suggests that there is obviously an upper pressure limit beyond further increase of     pressure seems contra productive. This upper limit is around 30-40 mm Hg of initial pressure     exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity.     This study is designed to investigate the effect of pressure on %volume reduction of leg     lymphoedema with 2 bandages which are very comparable in product properties (slippage,     stiffness, etc.), but differ in their pressure exerted to the limb.   "
111340|NCT01828593|"     The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy     serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0     g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated     enteropathy.   "
111341|NCT01828580|"     The main objectives of this study are to evaluate the safety and performance of the AutoLap     system in Laparoscopic Cholecystectomy procedures.   "
111342|NCT01828567|"     The VA has committed to disseminate a web-based Healthy Living Assessment tool and use it as     the cornerstone of a personalized prevention plan to engage patients to improve their health     behaviors that lead to high health risk. Health risk assessments done in isolation, however,     do not generally lead to behavior change. Our study will test the effectiveness of a Shared     Decision Making intervention designed to activate Veterans to enroll in effective prevention     programs. The intervention will be conducted over the telephone, by a prevention coach, and     will be linked to the patients' primary care team. The co-primary outcomes will be patient     activation and patient enrollment in prevention programs; 10-year risk of major cardiac     events will also be measured.   "
111343|NCT01828554|"     The purpose of this research study is to find what happens to capecitabine in the body when     dosed using actual versus ideal body weight in subjects with advanced tumors and elevated     body mass index.   "
111344|NCT01828541|"     The purpose of this study is to determine whether hypnosis will decrease the intensity of     either pain or itch in patients who have sustained a burn injury. Primary hypothesis:     Hypnosis will provide more effective relief from post-burn itch and pain than a control     intervention at 1-month, 3-months, 6-months and 1-year post-burn injury.      Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and     fewer symptoms of Post Traumatic Stress Disorder (PTSD).      Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the     gabapentin doses and have lower average pain scores than those in the control group.      Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early     after injury will report lower rates of neuropathic pain and itch than subjects who will be     enrolled in the study and receive hypnosis later in the healing process.   "
111345|NCT01828528|"     The purpose of this study is to investigate the effect of weight loss rate on liver     steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and     after bariatric surgery. The investigators also aim to study the short-term effect of     bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric     surgery.   "
111346|NCT01828515|"     The purpose of this study is to examine whether vilazodone attenuates the memory and mood     effects of corticosteroids on the human hippocampus in 18 healthy controls.   "
111347|NCT01828502|"     RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of     secondhand smoke exposure can protect the child from future exposure to tobacco smoke.      PURPOSE: This randomized study will compare education only to education plus cotinine     feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that     reside with a household smoker.   "
111348|NCT01828489|"     This study evaluates the effect of different induction courses in children and adolescents     with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to     receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In     the second course patients are randomised between standard treatment with ADxE (cytarabine,     DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine,     DaunoXome).   "
111349|NCT01828476|"     The purpose of this study is to assess the effect of combining abiraterone with medicines     that may block some of the ways that cells become resistant to abiraterone. The investigators     hope that these combinations of medicines will result in prostrate cancer cells dying.      This study will see if overcoming diseases resistance to abiraterone will restore sensitivity     to androgen deprivation therapy.   "
111351|NCT01828437|"     Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized     by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of     hypsarrhythmia. When all 3 components are present, the eponym West syndrome is commonly     used. West syndrome is a catastrophic epileptic encephalopathy. It does not respond well to     standard anti-epileptic drugs. Hormonal therapy is the mainstay in the treatment of infantile     spasms. This includes adreno-cortico trophic hormone (ACTH) and oral steroids. Variable dose     of prednisolone used in the treatment. Oral prednisolone used in usual dose (2mg/kg) has been     shown to be less effective as compared to ACTH. High dose prednisolone (4mg/kg) has been used     in the treatment of infantile spasms, which has been shown to be as effective as ACTH.     Pyridoxine has been used as first line treatment in Japan, however there is paucity of data     on the efficacy of combination of pyridoxine with hormonal therapy. There are no studies     comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the     treatment of infantile spasms. Therefore the study has been planned to see whether the     addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms     improves the efficacy in terms of spasm cessation.   "
111352|NCT01828424|"     There is a large variability of postoperative pain intensity and of the drug doses necessary     to alleviate this pain. The investigators hypothesis is that a measurement of nociception at     the end of surgery, using either the RIII reflex threshold, measures of heart rate     variability or the pupil dilatation reflex measured by pupillometry, in relation to the doses     of opioids used intraoperatively will yield a prediction of postoperative pain.   "
111353|NCT01828411|"     This prospective observational pilot study investigates transpharyngeal ultrasonography (TPU)     as an additional neuromonitoring strategy to assess cerebral perfusion during on-pump     cardiovascular surgery.      In the first part of the study the investigators will investigate the feasibility of TPU for     visualization of aortic arch branches including the innominate and the carotid arteries in     twenty patients undergoing coronary artery bypass grafting with extracorporeal circulation     (cohort 1.). In the second part the investigators plan to adopt the investigators previous     experiences on TPU to a selected population of twelve patients undergoing ascending aortic     and/or arch repair in deep hypothermic circulatory arrest (DHCA, cohort 2.). In contrast to     cohort 1., patients in cohort 2. are exposed intraoperatively to intermittent cerebral     perfusion stops or reductions due to surgical procedure, perfusion technique and their     underlying disease (aortic dissection or aortic aneurysm).      The investigators hypothesize that cerebral perfusion monitoring using TPU as a non-invasive     technique provides a simple and real-time adjunct to assess blood flow velocity in the     extracranial cephalic vessels with Doppler ultrasound. Especially in aortic arch surgery with     its inherent risk of cerebral hypoperfusion TPU might be a valuable adjunct to routine.   "
111354|NCT01828398|"     After stroke a limited motor recovery in the paretic upper limb accounts for a large     proportion of the disabling sequelae. Only about 15% of those with initial complete upper     limb paralysis after stroke recover functional use of their impaired arm in daily life.      The aim of this study is to test the effects of tDCS combined with upper extremity     robot-assisted therapy on stroke survivors.   "
111355|NCT01828385|"     The aim of this study is to determine the recovery time of moderate neuromuscular blockade     with sugammadex in adults pretreated with magnesium sulfate.   "
111356|NCT01828372|"     The study includes two study parts in which blood is collected from the patients.      Study part A (observational study, already received positive ethics committee vote; Our sign:     12-330): Use of blood samples gathered during routine blood withdrawal Study part B     (interventional study in the sense of additional blood samples but without an investigational     product): Optional, for further pharmacokinetic questions: blood withdrawal with a maximum of     20 ml ( ten tubes of 2 ml each) within a maximal study length of four weeks.      The primary objective of this study is to gain an overview about drug concentrations in     plasma and/or cerebrospinal fluid (CSF), in order to determine pharmacokinetics of drugs in     patients. Any drug may be tested, however the initial focus is on antiinfective,     antineoplastic, and antipsychotic drugs.      Many published studies show that there is a profound lack of information on pharmacokinetics     and interactions of many commonly used drugs in clinical routine, and that drug     concentrations, if controlled by therapeutic drug monitoring, are not in the therapeutic     range (provided that such ranges are known at all).   "
111357|NCT01828359|"     The purpose of this study is to evaluate the blood pressure lowering effects of an     amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination     treatment in patients with essential hypertension uncontrolled with losartan 100mg     monotherapy.   "
111358|NCT01828346|"     This is a dose escalation followed by dose expansion study of TL32711 in combination with     5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have     failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that     5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.   "
111359|NCT01828333|"     The MATIAS study aims to demonstrate through limited scope implementation studies how     injectable artesunate may be progressively rolled out nationwide in the Democratic Republic     of the Congo as the preferred treatment for severe malaria.   "
111360|NCT01828320|"     There is an urgent need to identify modifiable mechanisms contributing to risk and     vulnerability among youth. The investigators test the hypothesis that eveningness, the     tendency to go to sleep late and wake late, is an important contributor to, and even cause     of, vicious cycles that escalate vulnerability and risk among youth. This study seeks to     determine whether two interventions to reduce eveningness can reduce risk and confer     resilience in critical aspects of health, development and functioning in youth.   "
111361|NCT01828307|"     Relapse contributes significantly to the chronicity of substance use disorders, one of the     most costly medical/mental health problems facing our nation. The incorporation of exercise     into relapse prevention efforts will address stress, a critical factor in relapse, provide     other health benefits, and improve overall quality of life. Combined, these changes will     reduce the risk of relapse to substance use while also lessening the burden of this     psychiatric disorder upon society   "
111364|NCT01828268|"     The purpose of this plot study is to find out the relationship between metabolic changes and     anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients     using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics     methodology.   "
111367|NCT01828229|"     Epidemiological studies as well as both longitudinal animal and human inactivity studies     indicate that low physical activity is associated with the pathophysiology of type 2 diabetes     mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity     (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a     high energy dietary intake, and T2DM are also associated with dementia, depression, and     impaired cognitive function. It is critical that we understand how inactivity alters body     composition, glucose and lipid metabolism, and cognitive function, if normal physical     activity can prevent these changes, and if there are any differences between sexes.      The present protocol is divided in several in several sub-studies:        1. To test whether and how a physically inactive lifestyle will influence body composition,          glucose and lipid metabolism, and cognitive function.        2. To test whether normal physical activity can prevent the deleterious effect of a          physically inactive lifestyle despite a high-caloric intake.        3. To test whether the influence of a physically inactive lifestyle combined with a          high-caloric intake differs between sexes.   "
111368|NCT01828216|"     Very few studies have examined different models of care involving initial ambulatory     home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who     benefit from continuous positive airway pressure (CPAP), and reducing the need for     polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home     diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the     conventional approach in managing OSA in terms of improvement of clinical outcome but the     former approach will lead to substantial cost savings.   "
111369|NCT01828203|"     The objective of this study is to assess the efficacy of IV minocycline in improving     neurological and functional outcome after acute non-penetrating traumatic spinal cord injury     (SCI).      The primary hypothesis is that intravenous minocycline twice daily (800 mg initial dose     tapered to 400 mg by 100 mg at each dose then administered to the end of day 7) administered     to subjects with acute traumatic non-penetrating cervical SCI starting within 12 hours of     injury will improve motor recovery as assessed by the International Standards for Neurologic     Classification of Spinal Cord Injury - ISNCSCI (a.k.a. ASIA) neurological examination     measured between 3 months and 1 year post-injury, compared to placebo.      The secondary hypotheses are that the above minocycline treatment will also results in     improvement in ASIA sensory improvement, in ASIA grade and in functional outcome as assessed     by Spinal Cord Independence Measure (SCIM) and Short Form 36 (SF-36), compared to placebo. In     addition the effect of minocycline on neurological and functional outcome after SCI is     expected to be more pronounced in those subjects with motor incomplete SCI compared to those     with motor compete SCI. A subgroup analysis will be undertaken to examine this hypothesis.   "
111370|NCT01828190|"     The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on     patient suffering from residual Crohn's disease related perianal fistulas already treated     with TNF alpha blockers   "
111371|NCT01828177|"     This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of     PDI-320, and the individual components, in adult subjects with rosacea.   "
111372|NCT01828164|"     To study whether or not the Aevo System™ medical device enhances the rate of tooth movement     in human subjects who use orthodontic braces.   "
111373|NCT01828151|"     To assess risk of skin pressure lesions in patients treated with noninvasive mechanical     ventilation.   "
111374|NCT01828138|"     Preeclampsia (PE) is a common disorder of pregnancy that complicates 4-7% of all pregnancies.     It is a serious condition with acute proteinuria and hypertension and varying degrees of     edema after 20 weeks of gestation. PE leads to a severe risk of low birth weight because of     prematurity with inherent complications. The pathogenesis is unknown but is assumed to     involve placental ischemia.The primary placental disorder results in renal glomerular injury.     Established PE is associated with paradoxical suppression of the     renin-angiotensin-aldosterone system, RAAS.      Despite suppressed RAAS, patients with PE retain NaCl(sodium chloride) after an intravenous     isotonic NaCl overload compared to healthy pregnant women on a low NaCl diet. The     investigators believe to have data that provide a possible explanation for the overall     relationship between proteinuria, NaCl retension, suppression of RAAS, hypertension and     underdevelopment of placenta. Earlier data, which the investigators have confirmed, shows     abnormal glomerular loss of the enzyme plasmin/plasminogen from plasma to the urine in PE.     Active plasmin in urine from patients with nephrotic syndrome and PE activates the epithelial     sodium channel ( ENaC ) in renal collecting duct cells. The investigators hypothesize that     loss of plasmin/plasminogen are shared for the diseases with proteinuria, including PE, and     that plasmin- driven ENaC (epithelial sodium channel) activation is a causal factor in the     pathophysiology of established PE. Hyperactive ENaC causes primary renal sodium retention     with secondary suppression of the renin-angiotensin-aldosterone system. Aldosterone is     recently established as a placental growth factor.      Plasma-aldosterone levels are significant higher in normal pregnant women. PE is     characterized by low aldosterone levels (a discovery the investigators have also confirmed)     and by placental underdevelopment.      Study Aim: To test specific hypothesis regarding established PE´s pathophysiological     mechanisms.      Study Hypothesis:        1. Excretion of urine proteases (plasmin/plasminogen) in PE leads to an activation of ENaC          and hence RAAS is less NaCl sensitive while the blood pressure is more NaCl sensitive          compared to healthy pregnant women.        2. The degree of aldosterone suppression in PE determines placental development   "
111375|NCT01828125|"     In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because     of its potent and rapid action starting as fast as 5 minutes after subcutaneous or     intramuscular injection. Large dose of glucagon such as 1 mg subcutaneous is usually     associated with undesirable side-effects such as nausea, vomiting, bloating and headache.      The overall objective of this research proposal is to assess the efficacy of lower     subcutaneous doses of glucagon (0.1 mg or 0.2 mg) to correct hypoglycaemia compared to the     standard dose (1.0 mg) in adults with type 1 diabetes mellitus (T1D).      It is postulated that much lower dosages of glucagon (0.1 or 0.2 mg) injected subcutaneously     will be just as effective as the current recommended dose of 1.0 mg to correct hypoglycaemia     without the undesirable gastro-intestinal side effects.   "
111376|NCT01828112|"     The primary purpose of the study was to compare the antitumor activity of LDK378 vs.     chemotherapy in patients previously treated with chemotherapy (platinum doublet) and     crizotinib.   "
111379|NCT01828073|"     This study will evaluate the safety and pharmacokinetics (PKs) of exposure (in utero or     intrapartum) to raltegravir (RAL) in infants born to HIV-infected pregnant women who received     RAL during pregnancy. (Pharmacokinetics are the various interactions between a drug and the     body.) This study will also seek to develop an infant RAL dosing regimen to be evaluated in a     follow-up study.   "
111380|NCT01828060|"     The purpose of this study is to evaluate the timing and magnitude of improvements to red     blood cell health associated with consumption of Jobelyn™.   "
111381|NCT01828047|"     The aim of this pilot study is to establish if a correlation between sub-lingual     microcirculation measured by Orthogonal polarization spectral (OPS) imaging and symptoms of     postoperative ileus exist in patients undergoing elective colorectal surgery.   "
111385|NCT01827995|"     It is estimated that around 50 000 women die every year due to consequences of unsafe     abortion (Singh et al, 2009). A majority of these deaths occur in low-income countries where     access to safe abortion care is limited. Unplanned pregnancy and unsafe abortion thus place a     huge burden on scarce medical resources. Any improvement in Comprehensive Abortion Care (CAC)     would mean important improvements for the concerned women and their families (Singh, 2006) as     well as for the societies at large. Recommended improvements concern increased access to the     safest and most cost-effective methods such as medical abortion provided at primary level     facilities (Singh et al, 2009). A Cochrane Review concludes that most randomised controlled     trials within the field of medical abortion are conducted in high-income settings with good     access to emergency health care services (Kulier et al, 2004). A simplified regime for     medical abortion, which could be used at primary level facilities, would contribute to the     reduction of maternal mortality and morbidity related to unsafe abortions globally. However,     there is a knowledge gap in order to determine if a simplified follow up of medical abortion     is equally effective as the standard procedure in a low-income setting. The results will     provide evidence-based information to be used in revising training and service delivery     guidelines' in order to reduce maternal mortality and morbidity in both low and high-income     setting.   "
111386|NCT01827982|"     The purpose of this study to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of JNJ-54861911 which is currently being developed for the treatment of     Alzheimer's Disease.   "
111387|NCT01827969|"     The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by     MRI, performed under local anesthesia and sedation.   "
111388|NCT01827956|"     Hypothesis:      Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally     advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers     of Cetuximab antitumor activity are known in this setting. It has been shown recently that     FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of     trastuzumab and cetuximab.      The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may     play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with     recurrence or metastatic disease that make them inaccessible to loco regional treatment.   "
111389|NCT01827943|"     In the absence of standard treatment in this indication, this test evaluates a new drug type     targeted therapy in this indication, evaluating its efficacy in terms of tumor response and     survival.   "
111390|NCT01827930|"     The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with     CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response     and major molecular response rate) is dependent on the residual plasma Imatinib.   "
111391|NCT01827917|"     The objective of this study was to achieve the post-marketing protective effect research of     Speeda® rabies vaccine for human use from Chengda Bio.   "
111392|NCT01827904|"     The objective of this prospective, randomized, double-blind (to subjects, local site's     blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study     (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of     treatment using the ExAblate Transcranial System and to further demonstrate safety in     medication-refractory tremor in subjects with essential tremor (ET).   "
111393|NCT01827891|"     This single-center, randomized controlled trial is to investigate the impact of remote     ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its     long-term impact on renal function for patients with diabetes undergoing percutaneous     coronary intervention.   "
111394|NCT01827878|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fed condition in normal,     healthy, adult, human subjects.   "
111395|NCT01827865|"     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,     two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to     assess the bioequivalence between Test Product and the corresponding Reference Product under     fasting condition in healthy, adult human subjects.   "
111396|NCT01827852|"     This prospective observational study will evaluate the efficacy and safety of first-line     Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups     (<60, 60-69, 70-79, >80 years) in patients with inoperable advanced, metastatic or recurrent     adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the     start of first-line therapy.   "
111398|NCT01827826|"     It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing     to this national trend is the obesity epidemic. Three randomized trials have demonstrated     that intensive behavioral interventions can prevent or delay the onset of diabetes. The     purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a     population-based, telephonic, exercise and weight loss intervention to translate the findings     of the Diabetes Prevention Program into practice. The telephonic intervention will be     compared to usual care (30 participants in each group). The investigators will deliver the     intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a     total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24     weeks.      For this planning grant the investigators do not have an overall hypothesis. The     investigators' goal is to develop and test whether it is possible to do exercise and weight     loss   "
111399|NCT01827813|"     OBJECTIVE To assessment the results of repeated saturation and 10-12 core biopsy protocols in     patients with a negative initial biopsy but continued suspicion for prostate cancer MATERIALS     AND METHOD Data of the patients who underwent prostate biopsy between June 2007 and June 2012     were retrospectively assessed. Patients with an abnormal digital examination findings and/or     abnormal serum prostate specific antigen levels were biopsied. The indication for a repeated     biopsy was determined as the continued suspicion for a malignancy after the initial benign     biopsy result and/or a pathology result consistent with a high-grade prostatic     intraepithelial neoplasia or atypical small acinar proliferation. Patients who underwent     saturation and core 10-12 biopsies at repeated biopsies were compared. Statistical analyses     were performed with Shapiro-Wilk test and Mann- Whitney U test. A p value less than 0.05 was     accepted as statistically significant.   "
111401|NCT01827787|"     This research study is a phase II clinical trial. Phase II clinical trials test the     effectiveness of a drug to learn whether the drug works in treating a specific cancer.      Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with     metastatic breast cancer who have received at least two prior chemotherapy regimens. It works     by interfering with cancer cell division, growth and spread.      In this research study, the investigators are looking to see how well Eribulin helps     participants with metastatic breast cancer as a first-line or second-line chemotherapy     treatment. The investigators also would like to learn about the side-effects that     participants experience with this medication, in particular, neuropathy.      Neuropathy is a condition in which the nerves are affected, leading to numbness or tingling     of the fingers and toes. The investigators would like to study the effect Eribulin has on the     nerves through regular questionnaires that ask about any nerve-related symptoms. The     investigators also plan to send blood samples to determine if gene markers may indicate     increased sensitivity to the nerve effects of Eribulin.   "
111402|NCT01827774|"     The purpose of this Study is to collect information about the performance of the Surgisis®     Soft Tissue Graft (Study Product) for the repair of pelvic organ prolapse in women.   "
111403|NCT01827761|"     This study will evaluate whether chemotherapy teaching sessions improves patient's knowledge,     preparedness and anxiety in relation to chemotherapy. This study will also evaluate the     effect of age, race, native language, education level, type of cancer and chemotherapy     regimen on the oncology teaching session.   "
111404|NCT01827748|"     The purpose of this study is to evaluate the accuracy and repeatability of an individually     validated prototype autorefractor designed to be mounted on a surgical microscope.   "
111405|NCT01827735|"     Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused     by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing     pancreatic beta cells thus leading to insulin deficiency and development of hyperglycaemia.     Currently, medical management of type 1 diabetes focuses on intensive insulin replacement     therapy to limit complications (retinopathy, nephropathy, neuropathy); nevertheless clinical     outcomes remain sub optimal. There are intensive efforts to design novel immunotherapies that     can arrest the autoimmune process and thereby preserve residual insulin production leading to     fewer complications and better clinical outcomes.      The vast majority of genes that contribute to susceptibility to type 1 diabetes have been     found to encode proteins involved in immune regulation and function. In particular, several     susceptibility proteins are involved in the interleukin 2 (IL-2) pathway that regulates T     cell activation and tolerance to self antigens. Aldesleukin is a human recombinant IL-2     product produced by recombinant DNA technology using genetically engineered E. coli stain     containing an analog of the human interleukin-2 gene. There is substantial nonclinical,     preclinical and clinical data that ultra low dose IL-2 (aldesleukin) therapy can arrest the     autoimmune mediated destruction of pancreatic beta cells by induction of functional T     regulatory cells. However, prior to embarking on large proof of concept trials in type 1     diabetes it is essential that the optimum dose of IL-2 (aldesleukin) is determined. The     objective of this study is to establish in patients with type 1 diabetes the optimal dose of     IL-2 (aldesleukin) to administer in order to increase T regulatory cell response.   "
111413|NCT01827631|"     This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in     healthy male and female subjects. This study will confirm the PK and safety profile in     Chinese subjects. GSK1605786 is currently in clinical development for the treatment of     Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or     500mg twice daily) within 30 minutes after a meal. The study will consist of single and     repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.   "
111414|NCT01827618|"     This study aims to evaluate the effects of rapamycin directly on bladder tumors and the     effects of rapamycin on the immune system of patients with bladder cancer.   "
111415|NCT01827605|"     This is a Phase III, multicenter, open-label, randomized and controlled study to compare the     efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR     after second or third line chemotherapy supplemented with rituximab.   "
111416|NCT01827592|"     Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation     treated for 26 Weeks.   "
111406|NCT01827722|"     CRVO occurs when the vessels in the back of the eye become blocked. This creates a dangerous     condition because the vessels are weak and prone to leakage. This results in the development     of macular edema.      Previous studies have shown that inflammatory mediators and growth factors, such as vascular     endothelial growth factor (VEGF), are elevated in patients with macular edema associated with     CRVO.      Ozurdex® is approved by the Food and Drug Administration (FDA) and is available by     prescription for macular edema following CRVO and branch retinal vein occlusion (BRVO). It is     also indicated for the treatment of non-infectious uveitis affecting the posterior segment of     the eye. The approved dosage is 0.7 mg.      Ranibizumab (Lucentis®) is approved by the Food and Drug Administration (FDA) and is     available by prescription for other eye disorders, such as wet age-related macular     degeneration (AMD), macular edema following CRVO or BRVO, and diabetic macular edema (DME).     The approved dosage for wet AMD and macular edema following CRVO/BROV is 0.5 mg given     monthly. The approved dosage for DME is 0.3 mg given monthly.      Dr. Gonzalez is conducting an investigational study on the safety and effectiveness of     treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex® and 0.5 mg     Lucentis®, given as separate injections into the eye.   "
111431|NCT01827384|"     This randomized pilot phase II trial studies molecular profiling-based targeted therapy in     treating patients with solid tumors that have spread to other places in the body and usually     cannot be cured or controlled with treatment. WEE1 inhibitor MK-1775, everolimus, and     trametinib are drugs that each target a specific variation in tumors by blocking different     proteins needed for cell growth. Veliparib blocks an enzyme that helps repair     deoxyribonucleic acid (DNA) damaged by chemotherapy, which may help chemotherapy drugs work     better. It is not yet known whether testing patients for variations in their tumor and     assigning treatment targeting the variation is more effective than standard non-targeted     therapy in treating advanced solid tumors.   "
119696|NCT01719185|"     This is a pilot study designed to test the hypothesis that the combination of phentermine and     B12 will result in significantly greater weight loss among obese patients compared to     phentermine alone.   "
111407|NCT01827709|"     Chemo-radiotherapy (CRT) is currently the cornerstone in the management of locoregional     advanced head and neck cancer (HNC). Optimization of the quality of RT is therefore an     important issue, if the investigators want to improve the therapeutic index in HNC. This     could be achieved by a more accurate definition of the tumor volume and by identification of     radioresistant volumes within the tumor. Recent literature puts in this regard the     incorporation of functional imaging (FI) in the RT treatment planning forward as a promising     tool.      FI modalities provide an outstanding contrast between tumor and surrounding tissues. This is     in contrast to anatomical imaging. Using anatomical imaging in RT treatment planning,     sufficient margins need to be placed around the tumor volume in order to compensate for     geometric uncertainties. Consequently many surrounding functional structures receive high     doses of irradiation, resulting in side effects. It is expected that, using FI in RT     treatment planning will make these margins smaller or even unnecessary, which will result in     less irradiation of the surrounding tissues. So far only one study has reported a comparison     between tumor volume on anatomical (CT and MRI) and FI (PET-CT) modalities with pathological     tumor volume. This study showed indeed that the tumor volumes delineated on PET-CT correlated     more to tumor volumes defined by pathology and were significantly smaller.      Furthermore, FI provides us with a deeper insight in the tumor's underlying biological     activity and microstructure. These techniques can thus help to identify radioresistant     subvolumes which might benefit from treatment intensification.      A validation of these FI modalities with pathology is necessary to investigate their true     power in tumor delineation and in the identification of radioresistant subvolumes.   "
111408|NCT01827696|"     Healthy participants will ingest American ginseng daily or a placebo for four weeks prior to     engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness.     Muscle soreness will be assessed via decrements in muscle strength and with a self-rating of     perceived soreness before and several times after the exercise.   "
111409|NCT01827683|"     The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on     patients suffering from chronic pain syndrome (Fibromyalgia).   "
111410|NCT01827670|"     Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice     daily brushing of a toothpaste containing stannous fluoride in comparison to marketed     (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous     fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed     (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.   "
111411|NCT01827657|"     This is a single-dose, open-label, two part, parallel group study. This study is being     conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in     subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll subjects     with mild and moderate hepatic impairment and healthy control subjects matched to the     subjects in the moderate hepatic impairment category. The decision to commence Part 2 will be     based on a review of the preliminary safety and pharmacokinetic data from subjects with     moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic impairment.     Additionally, based on emergent data from Part 1, matched controls to the severe hepatic     group may be enrolled (optional). Due to the potential difficulty in identifying eligible     subjects with severe hepatic impairment, the study may be stopped prior to full enrollment in     Part 2, provided that a minimum of 4 evaluable subjects with severe hepatic impairment have     been enrolled. The study will consist of a Screening visit, a single dose Treatment Period     and a Follow-up visit. Subjects will be screened for eligibility criteria within 30 days of     enrolment. Subjects will be admitted to the clinical unit on Day -1; each subject will     receive a single dose of GSK2336805 on Day 1 and will remain in the clinical unit for 5 days     (check-out on Day 4). The follow-up visit will be conducted within 7-10 days after Day 1     dosing.   "
111412|NCT01827644|"     This will be a randomized, open-label, sequential, single dose, 4-period crossover study.     This study is being conducted to measure the relative bioavailability of the original gelatin     capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose [HPMC]     capsule and enteric coated tablet [ECT]) of afuresertib (AFU), in the fed and fasted state.     The study will be composed of Screening, Treatment, and Follow-up Periods. Screening     assessments to determine subject eligibility will be performed within 3 weeks prior to the     first dose of study drug in the Treatment Period. Eligible subjects will be randomized to     receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B:     AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D:     AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F:     AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period).     Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on     Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB, ABFC,     BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses     administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days     after the last dose. A subject's total time involved in the study will be approximately 9     weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6 subjects     will be randomized to receive each treatment sequence.   "
111418|NCT01827566|"     The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a     double-blind placebo-controlled challenge with gluten, followed by two months period of     Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in     patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure     and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.   "
111432|NCT01827371|"     Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over     2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate     three different immunization schedules and two different modes of delivery. The study will     look at condensed schedules. Study will randomize subjects to one of four arms.   "
111766|NCT01823003|"     This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in     selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer     to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with FFF     beams. Other aims are To evaluate the incidence of acute and late complications; To evaluate     tumour response to local radiation therapy by means of CT, PET/TC and MRI and To evaluate the     impact of local therapy on overall and disease-free survival.   "
111419|NCT01827553|"     This randomized trial examines the effectiveness of chemoradiotherapy compared to     chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of     FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic     cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles,     the agent and its administration for sole chemotherapy is determined by induction     chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will     be followed for the duration of therapy and for 5 years after the last study treatment.     Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints     are tumor-free survival, rate of local recurrence or local progression, rate of distant     metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of     remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is     planned to include a total number of 830 patients.   "
111420|NCT01827540|"     To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and     without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy     subjects.   "
111421|NCT01827527|"     The purpose of this study is to develop and refine techniques for using magnetic resonance     and optical spectroscopy to investigate how your body uses energy.   "
111422|NCT01827514|"     Erythropoietin, EPO, is the main regulator and stimulator of bone marrow erythropoiesis, and     is responsible for growth and differentiation of the erythroid cell lineage. Our team, in     collaboration with partners (see below) has taken responsibility to study the presence,     function and clinical significance of EPO-R in human cancer specimens.      General Aim of the Proposed Project: To study EPO-R in human cancer specimens. Prepared     slides from already taken preparations (specimens from Bone Marrow tests) will serve as the     basis for that part of the work.Specimens will be taken from Breast cancer, Colon cancer,     Lung cancer, Head & Neck cancer and from Lymph nodes biopsy (positive for lymphoma) The     slides will be stained with anti-EPO-R antibodies (Abs).   "
111423|NCT01827501|"     This study is designed to compare the incidence of postoperative delirium in older patients     after major non-cardiac surgery with different perioperative hemodynamic managements: a goal     directed hemodynamic management group and a control group   "
111424|NCT01827475|"     The purpose of this study is to determine whether the combination of ibuprofen and     acetaminophen, is more effective than either single agent alone in treating pain from acute     musculoskeletal injuries in the emergency department.   "
111425|NCT01827462|"     In this study the investigators are trying to understand how immune function declines in the     elderly using annual influenza vaccinations as a model system. The longitudinal study began     in 2007 and continued through early 2017.   "
111426|NCT01827449|"     The study will compare the rewarming effectiveness of heat donation through the distal arms     and legs during rewarming of mildly hypothermic subjects. Warming will be accomplished     through either warm water immersion; and fluidotherapy. The investigators hypothesize that     fluidotherapy will be as, or more, effective compared to warm water immersion   "
111427|NCT01827436|"     The purposes of this pilot research study are 1. To begin to test if two different types of     physical therapy might have different results in children and adolescents who have had a     prior stroke, and 2. To determine if either type of physical therapy causes changes in the     brain signals that control leg muscles. All participants will receive physical therapy 3     times per week for 8 weeks. Half of the participants will receive typical physical therapy,     such as walking practice, muscle strengthening, and balance training. Half of the     participants will receive asymmetrical gait training physical therapy, which uses new     technology to train each leg differently during walking practice. After enrolling,     participants will be randomly assigned to the type of therapy. Measurements will be taken     before, during, and after the 8 weeks of physical therapy. These include walking tests to     measure symmetry, walking speed and daily step activity, and brain tests to measure the     strength of the signals from the brain to the leg muscles. One blood test is also taken to     identify if certain genetic factors affect how each child responds to the physical therapy.   "
111428|NCT01827423|"     This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen     (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of     SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was     evaluated as well.      Blood samples from patients with sinonasal IP were examined to determine serum SCCA levels     before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and     postoperative levels of SCCA were compared.   "
111429|NCT01827410|"     Is there agreement between data in the Danish Ventral Hernia Database and patient files   "
111430|NCT01827397|"     The purpose of the clinical trial is to evaluate the safety and immunogenicity in female     volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The     objective of the immunisation is to induce mucosal and systemic binding and neutralizing     antibodies against HIV in order to block the virus on the mucosal surface and neutralise the     viral particles that may eventually succeed in crossing the mucosal barrier.      This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in     humans.      Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but     its ability to induce meaningful protection against HIV will not be known before Phase 3     efficacy trials are completed, as correlates of protection against HIV are not yet clearly     defined.      Consequently, there is no direct benefit to volunteers. They will be reimbursed for their     time and travel.   "
111523|NCT01826175|"     Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled     in this study. Subjects that are to be treated clinically with coronary artery stenting will     be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic     angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after     stenting and the presence of blood clots inside the new stent will be measured and compared     between the groups.   "
111548|NCT01825837|"     This was an extension study consisting of 2 parts. In Part I, all participants received     open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a     double-blind, parallel-group design in which participants were randomly assigned to treatment     with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission continued     double-blind therapy until approximately 6 months after the last patient entered Part II.   "
111433|NCT01827358|"     The objective of this trial is 1) to evaluate the safety and clinical acceptability of a     5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and     perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in     eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures     of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to     examine the efficacy of mupirocin in achieving persistent eradication of SA colonization     among infants residing in the ICU,defined as the absence of SA in cultures of the nares,     umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to     receive medical care as they otherwise would if they were not enrolled in the trial. The     study will be powered with a primary endpoint with 126 participants. Enrollment may continue     to 500 participants to power secondary and exploratory endpoints and assist design subsequent     studies.   "
111434|NCT01827345|"     The role of vitamin D deficiency on increased risk for falls and physical dysfunction is     unclear. It is also unclear if taking vitamin D improves physical function and reduces fall     risk in older adults. The purpose of this research study is to explore the effects of taking     the recommended dose of vitamin D (800 IUs/day) for six months on fall risk and physical     functional outcomes in older adults with low vitamin D levels. The investigators hypothesize     that the participants will experience fewer falls and function better physically after taking     vitamin D for six months.   "
111435|NCT01827332|"     The purpose of this study is to examine the impact of a medication called oxytocin on     marijuana use and therapy response in people who frequently use marijuana.   "
111436|NCT01827319|"     The objectives of the registry are as follows:        -  Track real world performance outcomes and physician experience using the Cardiogenesis          Laser System;        -  Further define the disease characteristics of the population being treated;        -  Examine transmyocardial revascularization (TMR) usage characteristics and 30-day          outcomes;        -  Further assess the 30-day postoperative risk factors for adverse events. To limit the          potential for bias, all patients eligible for TMR treatment who meet the Inclusion and          Exclusion Criteria are to be offered the opportunity to enroll in the study at          participating centers.   "
111437|NCT01827306|"     Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for     home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises     are considered an important component of care for shoulder pain patients, although pain can     be a limiting factor in the advancement of rehabilitation. The purpose of this study is to     evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to     determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical     shoulder pain who are candidates for standard shoulder therapy will be randomized into two     groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while     the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just     prior to initiating the in-office exercise program. Values of pain (NPRS) and disability     (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by     repeated measures ANOVAs within and between group, time, and interaction main effects.     Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the     associated disability. The ability to decrease shoulder pain and disability with a topical     analgesic will allow health care professionals to advance patients through a therapeutic     exercise program without the restriction of pain. In turn, patients will correct the     underlying condition of their shoulder pain at a faster rate.   "
111438|NCT01827293|"     This study was a prospective, randomized, double-blind, parallel group clinical trial     designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the     treatment of peripheral vertigo in Emergency Department setting.   "
111439|NCT01827280|"     The prevalence of obesity and type 2 diabetes mellitus (T2DM) has increased progressively in     the past decades, and consequently, a higher incidence of cardiovascular diseases is     observed. As this process develops, the endothelial dysfunction is present at early stages of     the atherosclerotic disease. Studies conducted at BioVasc/UERJ show the occurrence of     endothelial and microvascular dysfunction in obese carriers, even in the absence of     dysglycemia. New concepts indicate the endothelium as a possible therapeutic target, and     drugs which act not only on diabetes mellitus pathophysiology but also acting as direct     cardiovascular protectors bring new therapeutic possibilities. The dipeptidyl-peptidase-4     inhibitors (DPP4), such as vildagliptin, are drugs used on the T2DM treatment. Its incretin     mimetic and insulinotropic effects are already well established and several other studies     show its effectiveness in reducing glycated hemoglobin, even in monotherapy.      Currently, fat rich foods are being increasingly introduced in the western way of life and     recent evidence suggests that the postprandial lipemia (LPP) is related to cardiovascular     risk. A better glucose control using vildagliptin can reduce the oxidative stress, and     consequently promote a better microvascular and endothelial reactivity. However, vildagliptin     can have an additional cardiovascular protective action, not only because of its effect on     glycemia and oxidative stress reduction, but maybe because of its direct effect on intestinal     peptides with postprandial lipemia reduction. To test this hypothesis, we will proceed the     following exams: venous occlusion pletysmography, nailfold videocapilaroscopy and     laser-Doppler flowmetry aiming to evaluate vascular reactivity on muscle and at cutaneous     site. Anoter group of patients with the same clinical charactherisitics will use metformin,     in order to compare its effects with those obtained from the use of Vildaglitpin. Our purpose     is to determine whether vildagliptin, evaluated in obese and diabetic women, has vascular     protective effects, and whether the regulatory mechanisms of these actions correlate with     oxidative stress, inflammatory markers and intestinal peptides in baseline state and after a     lipid overload.   "
111440|NCT01827267|"     This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter,     multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus     combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented     somatic HER2 mutations.   "
111442|NCT01827241|"     With this study, we plan to review the performance of colonoscopy in colon cancer screening     and surveillance, especially with the recent improvements in endoscopic technology (high     definition endoscopes), use of split dose preparation which provides excellent colon     preparation for detection of lesions and increasing awareness and detection of flat lesions     of the colon. The findings will help us define the role of colonoscopy screening of colon     polyps and flat lesions and identity areas for improvement. The data will be used for     continuing quality improvement and presenting our outcomes at academic meetings and     publishing our results in peer reviewed journals.   "
111838|NCT01822067|"     The specific aim of this study is to use MRI methods to evaluate and compare brain structure     and function in two groups of full-term neonates at two-weeks of age: those born of obese     mothers and those born to normal weight mothers.   "
111839|NCT01822054|"     The specific aim of this research project is to use MRI methods to evaluate and compare brain     structure and function in normal weight and obese children age 8-10 years.   "
111443|NCT01827228|"     Half or more of HIV transmission events may occur within the period of high infectivity (and     often high risk behavior) that can last 11 months or more after a person is initially     infected. Unfortunately, neither test-and-treat intervention methods nor Acute HIV Infection     projects have found effective ways to intervene against transmission during this risky     recent infection period. The investigators seek to develop effective intervention     techniques against HIV transmission during the recent infection period using a combination of     injection-, sexual- and social-network-based contact tracing methods; community alerts in the     networks and venues of recent infectees; and the logic of going up and down infection     chains.      The investigators first Aim is to develop and evaluate ways to locate seeds, defined as     drug users and other people who have recently been infected. The investigators second Aim     targets members of seeds' networks and people who attend their venues. The investigators will     test them for acute and for recent infection, and alert them to the probability that their     networks contain highly-infectious members so they should reduce their risk and transmission     behaviors for the next several months to minimize their chances of getting infected. This may     also reduce transmission by untested people with recent infection. Community, network and     venue education about the need and value of supporting those with recent infection should     reduce stigma. The investigators third Aim is to reduce HIV transmission and to develop new     ways to evaluate prevention for positives generally as well as The investigators own     success in reducing transmission.      The investigators will do this using a combination of follow-up interviews and testing,     including of viral loads; phylogenetic techniques; and discrete event simulation modeling to     assess The investigators effectiveness.   "
111444|NCT01827215|"     This study is to examine the effectiveness of a health communication system (Gabby) that     assesses preconception health risks and tailors the education and intervention to each     subject, based on her health risks. This project specifically targets young Black or African     American women in order to reduce major disparities in birth outcomes. Clinicians do not have     time to assess for the over 100 preconception health risks that can impact birth outcomes;     the investigators system can streamline that assessment and create a personalized list of     risks. Patients can then share their list with clinicians to make their healthcare visits     more effective.      The investigators will conduct a two-armed randomized controlled trial (RCT) designed to     enroll 530 African American women ages 18-25. After all subjects complete a comprehensive     preconception health risk assessment, the intervention group will be trained to use the Gabby     system and encouraged to use it at least monthly for one year. The control group will receive     a letter listing the risks identified and they will be encouraged to see their clinician to     discuss them.      The investigators primary hypothesis will test whether the Gabby system will result in a     lower rate of preconception health risks, as defined by CDC, as compared to the control group     after 12 months. Secondary outcomes include: measurement of usage rates, dose of exposure,     attrition, subject and healthcare provider satisfaction, and number of women with a     personalized health plan.   "
111445|NCT01827202|"     Forced blockade of the renin-angiotensin-system (RAS) by using direct renin inhibition (DRI)     has long been propagated to effectuate beneficial outcomes. However, recent large clinical     trials have outlined harmful effects for DRI in combination with other forms of RAS blockade.     To date, information regarding DRI as RAS-blocking monotherapy is very limited. Furthermore,     it remains to be elucidated how DRI and angiotensin receptor blockers affect the so-called     'classical' and 'alternative' RAS molecularly. As components of the 'alternative' RAS (e.g.     Ang 1-7) have moved into research focus, it would be of importance to determine angiotensin     regulation with medical RAS blockade.      In this prospective, single-center randomized trial over 10 weeks, 24 patients with chronic     kidney disease (CKD) stage III-IV (eGFR 15-59 ml/min) will be randomized to take either     aliskiren (up to 300 mg per day) or candesartan (up to 16 mg per day) after a two week run-in     phase where all RAS-blockers are eliminated. The investigators will then employ a novel mass     spectrometry-based quantification method (after run-in and 10 weeks) to capture the     concentrations of ten different angiotensin peptides (including angiotensin I and II,     angiotensin 1-7 and angiotensin 1-5).      The investigators hypothesize that significant differences exist between angiotensin levels     in CKD patients with DRI compared to angiotensin receptor blockers. Specifically, the     investigators expect to determine the regulation of the alternative RAS represented by     angiotensin 1-7 with proximal versus distal blockade of the system.      Our data might contribute to a more profound understanding of results from registries and     clinical trials beyond the clinical effects of RAS blockade. Further, the study's results     might help to individualize and optimize RAS-blocking therapy strategies in CKD patients.   "
111446|NCT01827189|"     Examines staff size and composition of the 496 advanced primary care practices participating     in CMS's comprehensive primary care initiative, in 7 regions (states or local areas) that     were selected for the demonstration.   "
111447|NCT01827176|"     The purpose of this study is to determine the clinical characteristic of recurrent acute     rhinosinusitis in children.   "
111448|NCT01827163|"     The purpose of this study is to study a new treatment for HER2-positive breast cancer.   "
111449|NCT01827150|"     The present proposal investigates the influence of energy drinks on the blood oxygenation     concentration of the optic nerve on healthy subjects. On a voluntary basis, 15 subjects, man     or woman, will be selected to undergo this experiment. Many factors can influence the blood     oxygenation concentration of the optic nerve, which will be measured also during this     experiment, namely: Intra ocular pressure (IOP), blood pressure, heart rate and systemic     hemoglobin saturation.      The subjects will have to be tested twice to test the two conditions of this experiment:        1. The effect after the intake of a can of Redbull (250 ml)        2. The difference with the intake of 250 ml of water      The purpose of this study is to determine if the blood oxygenation concentration of the optic     nerve varies after having ingested 250 ml of Redbull.      Our hypothesis are:        1. The blood oxygenation concentration of the optic nerve measured with OSOME (see detailed          description below), decreases due to the consumption of the energy drink Redbull          compared to an equal volume of water.        2. The IOP measured with iCare tonometer decreases after the consumption of the energy          drink Redbull compared to an equal volume of water.        3. The systemic blood pressure, measured with an automatic sphygmomanometer remains          constant after ingestion of Redbull energy drink or an equal volume of water.        4. Heart rate, measured with a sphygmomanometer automatic increases after taking a Redbull          energy drink compared to an equal volume of water.        5. The rate of systemic hemoglobin saturation measured with a pulse oximeter remains          constant after the ingestion of a Redbull energy drink or an equal volume of water.   "
111581|NCT01825408|"     The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics     as part of maximal medical therapy for treating chronic sinusitis and thus preventing     patients from having to have sinus surgery. The hypothesis is that in the context of maximal     medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at     successfully treating chronic sinusitis.   "
111622|NCT01824875|"     This randomized phase II trial studies how well giving temozolomide with or without     capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs     used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. It is not yet known whether temozolomide is more effective with     or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.   "
111450|NCT01827137|"     The purpose of this study is to see if the investigator can help the immune system to work     against myeloma. Because cancer is produced by the patients own body, the immune system does     not easily recognize and fight cancer cells. The immune system needs to be trained to do     this.      This disease has been selected for this study because the Wilms Tumor 1 (WT1) protein is     often present in myeloma cells. WT1 is a gene that is involved in the normal development of     kidneys and other organs. When the WT1 gene becomes abnormal, it can make proteins involved     in the development of cancer. This study will determine whether the WT1 vaccine causes an     immune response which is safe and able to keep the myeloma from coming back.   "
111451|NCT01827124|"     Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of     placental delivery in 2nd trimester interruption.   "
111452|NCT01827111|"     The goal of this clinical research study is to learn if the combination of ipilimumab and     ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug     combination will also be studied.      Ipilimumab is designed to increase the immune system's ability to fight cancer.      Abraxane is designed to stop cancer cells from making new DNA (the genetic material of     cells). This may stop the cancer cells from dividing into new cells.   "
111453|NCT01827098|"     Both methods tested in this study disinfect the non-vital root canals and induce blood clot     formation inside the root canal. One method places calcium hydroxide inside the root canal     after disinfection and the blood clot is induced four weeks later.      The other method performs disinfection and induction of blood clot in one appointment. The     investigators hypothesize that both methods will obtain the same success rate in eliminating     infection, increase in root length and canal walls thickness.   "
111454|NCT01827085|"     The purpose of the study is to investigate wether the use of the Stortz video laryngoscope     will render in shorter time for the intubation of obese patients compared with the use of a     conventional Macintosh laryngoscope.   "
111455|NCT01827072|"     Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European     Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet     all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01     (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients     receive NPB-01 1g/kg every 3weeks and evaluate the Medical Research Council（MRC） score and     the Guy's Neurological Disability Scale（GNDS） et al.      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse     events by one year after the start of the study treatment.   "
111456|NCT01827059|"     SUMMARY Rationale: Pulmonary arterial hypertension (PAH) can be a rapidly progressive     disorder and is associated with a high mortality rate, despite medical intervention. With the     availability of effective therapy, early disease detection is an important strategic     objective to improve treatment outcomes. Resting echocardiography is currently the     recommended screening modality for high-risk population groups. However, it is clear that     abnormalities in resting hemodynamics (and symptoms) are late sequelae of the pathobiological     processes that begin in the distal pulmonary arteries. Exercise stress may unmask early     pulmonary vascular dysfunction, however the definition, clinical significance, and natural     history of 'exercise PAH' remain undefined. However, based on clinical experience and     literature the prevalence is estimated at ~ 20%.Treatment with endothelin receptor blockers     has shown a beneficial influence on the clinical performance in patients with exercise     induced PAH due to systemic sclerosis and primary pulmonary hypertension. Whether endothelin     receptor blockers decrease pulmonary pressures and improve clinical outcome in patients with     exercise induced pulmonary arterial hypertension due to congenital heart disease is unknown.      Objective: Identify congenital heart disease patients with exercise-induced pulmonary     arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in     patients with exercise induced pulmonary arterial hypertension before and after treatment     with bosentan, compared to placebo.      Study design: Randomized placebo controlled trial with a study period of 26 weeks.      Study population: Adult congenital heart disease patients with exercise induced pulmonary     arterial hypertension (n=40) from the Academic Medical Centre, Amsterdam.      Intervention: After randomization one group (n=20) receives a 125 mg tablet of Bosentan twice     daily for 6 months. The other group (n=20) receives placebo for 6 months.      Main study parameters/endpoints: To determine wether bosentan (endothelin receptor inhibitor)     decreases mean pulmonary arterial pressure at peak exercise in adult congenital heart disease     patients with exercise induced pulmonary arterial hypertension. Furthermore the change in     cardiopulmonary exercise capacity and right ventricular function will be investigated.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: All investigations, blood analysis excepted, are non-invasive and free of risk.     The burden for the patients mainly consists of the time that is consumed by the     investigations, namely: history taking + physical examination (15 min); Quality-of-Life-     score (15 min); laboratory tests (electrolytes, creatinine, urea, albumin and neurohormones,     troponin T); 12 lead electrocardiogram (10 min); exercise echocardiography (30 min);     cardiovascular exercise testing (30 min).      The trial medication has a potential risk of liver damage, which will be monitored regularly     by laboratory testing of liver transaminases.   "
111457|NCT01827046|"     A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally     invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).   "
111458|NCT01827033|"     This research is being done to learn about the effects of doing meditation (sitting quietly     and concentrating) on people's ability to pay attention and be relaxed.   "
111459|NCT01827020|"     The purpose of this study is to determine whether subanesthetic ketamine addition to     lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.   "
111460|NCT01827007|"     The aim of the study is to evaluate whether fluid responsiveness of the critically ill     patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood     pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left     ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test).     The chances are compared to increase of CI after volume expansion (gold standard). In     clinical practise, it would be especially relevant if PEEP-induced changes in arterial     pressure variations could be used in evaluation of volume status and fluid responsiveness.     However, as ECHO-derived variables are used in greater extent to guide the treatment with     inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic     measurements is essential in the study design.   "
111474|NCT01826825|"     The objectives of this pilot study are:        1. to determine whether a short cognitive test battery administered in the preadmission          test center can be used to cognitively stratify elderly patients presenting for elective          surgical procedures.        2. to evaluate the cost of cognitive screening in the preoperative testing center in terms          of time and finances.        3. to evaluate patient perceptions about the use of preoperative cognitive screening and          their outcome expectations from their surgical procedure.      Subsequent investigations may evaluate whether preoperative cognitive screening is a     predictor of postoperative morbidity and mortality in elderly surgical patients and whether a     short cognitive screen administered in the preadmission testing center could be used to     identify individuals with baseline cognitive impairments that should be refered for more     formal cognitive evaluation.   "
111475|NCT01826812|"     To assess the reading function impairment in patients with dry eye and to assess the effects     of reading on the ocular surface.   "
111461|NCT01826994|"     Rationale:      Thoracic complaints, possibly due to a cardiac ischemic cause are a diagnostic challenge in     general practice. When an underlying ischemic cardiac condition (AMI (acute myocardial     infarction), UAP (unstable angina pectoris)) is considered, referral from general     practitioner (GP) to a cardiologist has to take place. However, cardiac analysis in 80% of     referred patients is negative. To optimize referral decisions of GPs, new and fast     diagnostics are needed.      Objective:      To assess the incremental diagnostic value for AMI of a novel rapid PoC H-FABP-test in     addition to history taking and physical examination in patients presenting in daily general     practice with possible AMI. In addition the cost-effectiveness of the test will be evaluated.      Study design:      Delayed type cross-sectional diagnostic study.      Study population:      Patients presenting to the GP with any new-onset chest complaint, at time of presentation not     lasting for more than 24 hours, that is considered to be of possible cardiac origin by the     GP.      Intervention:      Point of care Heart Type Fatty Acid Binding Protein test (PoC H-FABP-test), added to usual     care. PoC H-FABP-testing, by qualitatively measuring H-FABP in one single drop of blood     obtained by finger prick, is added to normal procedures of consultation and referral decision     by the GP.      Main study parameters / endpoints:      Sensitivity, specificity, positive and negative predictive value of point of care     H-FABP-testing for AMI, alone as well as part of a clinical diagnostic algorithm, in patients     with thoracic complaints in general practice. All outcome measures, based on using an     algorithm and/or point of care H-FABP-testing, will be compared to regular diagnostic     assessment by the GP without using an algorithm and/or point of care H-FABP-testing.     Therefore, incremental value of H-FABP-testing and/or a diagnostic algorithm is measured.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      Individual participants will experience low risk, since study participation comprehends     regular care except for an extra finger prick and possibly collection of one extra venous     blood sample. For this low amount of disadvantage, the participant will experience no     advantage either. However, results of the study will possibly be useful for similar patients     in future.   "
111462|NCT01826981|"     The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of     combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic     hepatitis C virus (HCV) infection.   "
111463|NCT01826968|"     The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean     section and in women under general anesthesia improves lung compliance and gas exchange. The     investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8     cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment     maneuver. The primary end point of the study is the improvement of the lung compliance     measured as volume difference/pressure difference (dv/dp) or ml/cmH2O   "
111464|NCT01826955|"     The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position     could alter the rSO2 and early postoperative cognitive function.   "
111465|NCT01826942|"     In this study the investigators intend to determine the impact of fractional CO2 laser     treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face,     hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation.     The investigators will also evaluate the effect of shallow fractional laser treatment versus     deep parameters settings. If effective treatments could be performed at time of surgery, this     would result in both time and cost saving to the patient and to the healthcare system and     will improve patient's self-image post surgeries.   "
111466|NCT01826929|"     The purpose of this study is to determine whether a multifactorial primary care intervention     based on chronic models can improve the level of control and reduce the number of hospital     admissions in patients with ischemic heart disease.   "
111467|NCT01826916|"     EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and     efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients     with Hereditary Angioedema.   "
111468|NCT01826903|"     The purpose of this study is to examine whether the successful perinatal depression     intervention among mothers (Thinking Healthy Programme, THP) has led to improved     developmental outcomes in the children 6 years later. Economic and human resources aspects of     the intervention will also be evaluated to determine overall societal benefits from     investment in such a program, feasibility of scaling up the intervention and its     sustainability in the long-term. The primary hypothesis is that children of mothers who     participated in the THP will have better cognitive outcomes and socio-emotional functioning     when compared to children of mothers randomized to the control group.   "
111469|NCT01826890|"     Many patients admitted to intensive care have heart or lung problems. Patients with these     conditions often require longer durations of support from breathing machines. Survival and     long-term recovery are improved if the investigators can remove the breathing support     quickly. In this study, the investigators will focus on patients with severe lung or heart     disease to examine whether a particular type of breathing machine (NAVA ventilator) will     allow us to remove breathing support more quickly and with less need for sedative     medications, when compared to current practice.   "
111470|NCT01826877|"     This phase I trial studies the side effects and best dose of autologous dendritic cells in     treating patients with metastatic kidney cancer. Vaccines made from a person's tumor cells     and white blood cells may help the body build an effective immune response to kill tumor     cells.   "
111471|NCT01826864|"     This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see     how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating     patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune     system in different ways and stop cancer cells from growing. It is not yet known whether     sargramostim is more effective than hypertonic saline in treating patients with stage IB-II     melanoma undergoing sentinel lymph node biopsy.   "
111472|NCT01826851|"     Exparel is a new local analgesic (numbing medication) that is intended to be longer acting     than currently available local analgesics. The purpose of this study is to determine whether     use of Exparel to numb the nerves along the breastbone after open heart surgery, will     decrease pain and pain medication use after surgery.   "
111473|NCT01826838|"     Radiation and androgen deprivation is a common modality for patients with localized prostate     cancer. Unfortunately for patients with intermediate to high risk prostate cancer incomplete     tumor eradication and subsequent relapse occurs in 50-75% of patients. The Src pathway     appears to be integral to the pathobiology of prostate cancer and may be fundamental to     radioresistance.   "
111520|NCT01826214|"     The study will evaluate the efficacy, safety and tolerability of two dosing schedules of     LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated     acute leukemia.   "
111521|NCT01826201|"     The purpose of this study is to determine whether MOL4239 is effective in adult subjects with     mild to moderate plaque psoriasis by comparing two target lesions in which each subject will     apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target     lesion twice a day for 28.5 consecutive days.   "
111476|NCT01826799|"     Rationale: Sound levels in the Intensive Care Unit are frequently reported to exceed the     recommended levels. It is plausible to assume that this causes sleep disturbance in the     patients on the ICU.      Goals/endpoints: to assess sound pressure levels in 6 different Dutch ICU´s and evaluate the     effect of higher levels on sleep as perceived by the patient.      Study design: observational multicenter study      Study population: adult ICU patients > 18 years old with an expected duration of stay of more     than 24 hours      Study parameters/endpoints:      Primary        1. To gather information on how Dutch ICUs perform on sound levels             1. Average sound pressure level             2. Number of sound peaks        2. To question patients about their perception of sleep quality (measured by RCSQ)        3. Causes of elevated sound pressure levels        4. Identification of the most annoying sounds experienced by the patient      Secondary      1) Incidence of delirium measured by CAM-ICU   "
111477|NCT01826786|"     The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating     anxiety disorders through evaluation of brain activation patterns using imaging technology in     healthy volunteers.   "
111478|NCT01826773|"     The study is designed to evaluate how safe and how well an investigational imaging product     CardioPET™ performs as compared to standard approved imaging products in assessing the     function of heart muscle in coronary artery disease patients.   "
111479|NCT01826760|"     This study was to predict 3-month mortality risk of acute-on-chronic hepatitis B liver     failure (ACHBLF) on an individual patient level using artificial neural network (ANN) system.     The area under the curve of receiver operating characteristic (AUROC) were calculated for ANN     and MELD-based scoring systems to evaluate the performances of the ANN prediction.   "
111480|NCT01826747|"     The objective is to test the hypothesis that luteal phase support with vaginal progesterone     leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary     outcome) when compared to no luteal phase support in a program of intrauterine insemination     (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of     the luteal phase will be recorded (secondary outcome) in order to detect luteal phase     defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase     prolongation in case of luteal phase support which may be a burden for the patients waiting     for the outcome of the treatment.   "
111481|NCT01826734|"     Background Because dacryoliths occur at low frequency, few studies have focused on their     composition.      The investigators aimed to present findings from morphological, chemical, and mineralogic     analysis of 86 dacryoliths.      Methods The team studied 86 dacryoliths obtained during 832 dacryocystorhinostomies (DCR)     performed for postsaccal obstruction. The samples were analyzed with atomic infrared     spectrometry (80 samples), amino acid analysis (17 samples), scanning electron microscopy,     and an electron microprobe with an energy dispersive detector (7 samples).   "
111482|NCT01826721|"     Solid organ transplant recipients (SOTR) must follow complex medication regimens and require     a substantial amount of education for effective self-management. The current standard of care     for post-transplant medication teaching is a Self Medication education program conducted in     hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a     web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to     control the content, sequence, pace and timing of education in order to achieve personal     learning objectives, as well as the opportunity for ongoing review and reinforcement of     information, may be an attractive, convenient and effective teaching modality.      SOTR will be randomly assigned to receive the standard of care or the standard of care plus     the TMITT intervention. Primary objectives are to compare patient satisfaction and medication     knowledge between the two groups at baseline and 3 months using modified versions of     previously published questionnaires. Medication adherence as measured by a multidimensional     approach including both subjective and objective components, will also be compared at 3     months. Our hypothesis is that an education strategy that includes both the standard     pharmacist teaching followed by a tailored online e-learning intervention post-discharge will     lead to improved patient satisfaction, knowledge and medication adherence.   "
111483|NCT01826708|"     For every child with developmental delay, the investigators do a constitutional karyotype.     This karyotype can reveal an apparently balanced chromosomal rearrangement (no visible loss     or gain of genetic material), such as a translocation between two or more chromosomes of     accidental occurrence (not transmitted by parents). However, an apparently balanced     translocation does not explain the phenotype of the child. Among the hypotheses that could     explain the child's symptoms, there is the possibility of another chromosomal abnormality at     the translocation breakpoints, another defect elsewhere on the chromosomes or gene disruption     at or near the breakpoints. Because the resolution of a constitutional karyotype is limited,     these microanomalies can go undiagnosed. The goal of this study is to look for a microanomaly     on a chromosome using a technology of higher resolution than that of the conventional     karyotype. The proposed study uses DNA microarray technology on DNA extracted from blood     lymphocytes to perform high-resolution analysis of all chromosomes to search for an     unbalanced microrearrangement (such as loss or gain of chromosomal material). If no     microrearrangement is found, the investigators will pursue by looking for a gene disruption     defect at or near the breakpoints involved in the translocation. This will be done by first     isolating the chromosomes involved in the translocation by flow cytometry and then     hybridizing each of the isolated chromosomes on a new microarray. The purpose of this study     is to find a possible cause to explain the phenotype (microrearrangement or gene disruption).   "
111484|NCT01826695|"     Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with     generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms     like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological     disorders. This condition is very prevalent. It has been reported to be about 2-5% of the     general global population.      Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this     prospective study was to examine the combined effects of soft tissue mobilization and nerve     slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.   "
111522|NCT01826188|"     There are many reports about efficacy of Cannabis in Crohn's disease but no controlled     trials. The aim of the proposed trial is to investigate the efficacy of oil containing the     cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.   "
111485|NCT01826682|"     Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be     aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea     and the quantity of sputum purulence). This is known as exacerbation and it is the most     frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy program     is carrying out in patients attending to the Hospital because of an exacerbation.      The hypothesis of this study is that a physiotherapy program added to a medical treatment     increase the ventilatory function, the physiques variables, decrease depression and anxiety     and improve the quality of life. Additionally, it is going to be assessed the effect of     physiotherapy in time using phone calls and visits to the patient's home.   "
111486|NCT01826669|"     The study hypothesis is chest wall muscle stretching increase distribution of volume     variation of thoracoabdominal wall and reduce electromyographic activity of respiratory     muscles in patients with Chronic Obstructive Pulmonary Disease.   "
111487|NCT01826656|"     Both the pathogenesis and the treatment of osteoporosis may potentially interfere at     different levels on the multi-stage complex cascade of events involved in bone     healing/regeneration. To our knowledge no human studies have been performed to clarify the     potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of     the study is to compare alveolar bone changes in width and height 3 months after tooth     extraction in 10 post-menopausal osteoporotic women and 10 post menopausal non osteoporotic     women by the use of cone-beam computer tomography (CBCT) images. The secondary outcomes     considered are: clinical changes in the external contour of the ridge and periodontal     parameters in the neighbouring teeth after a tooth extraction and 3 months later. In addition     the accuracy of panoramic morphometric indexes in detecting osteoporosis will be measured.   "
111488|NCT01826630|"     The primary objective of this protocol is to acquire pilot data for a larger study to test     the following hypothesis: Treatment of the hands of patients with chronic hand     dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed     as a cosmetic product containing a dilute concentration of less than 0.01% sodium     hypochlorite and less than 0.005% concentration as it is lathered, will result in a     statistically significant reduction in the number of skin fauna present on the hands of these     patients compared to treatment of such patients with traditional wash used clinically such as     Cetaphil Daily Facial Cleanser.   "
111489|NCT01826617|"     This study will identify significant clinical parameters and individual risk factors related     to certain prostate disease (BPH, prostatitis and prostate cancer). With the identified     important correlations, a locally generated bias free nomogram will be constructed for     predicting prostate biopsy outcome among Asian men with indications for prostate biopsy.     While this study will evaluate the accuracy and predictive value of this novel prostate     disease nomogram.   "
111490|NCT01826604|"     The purpose of this study is to investigate the effects of the Alexis O C-section retractor     in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized     to the use of the Alexis retractor during Cesarean section (treatment group) or the use of     traditional hand-held retractors (control group). We will determine if there is any     difference in surgical site infection or wound disruption rates. We will also determine if     there is a difference in the duration of surgery or length of time from skin incision to     delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length     of stay, intra-operative or postoperative anti-emetic requirements, need for hospital     readmission or emergency room visits, or other complication rate between the two groups.   "
111491|NCT01826591|"     Genomics research is advancing rapidly, and links between genes and obesity continue to be     discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in     multiple genes have been shown to alter an individual's response to dietary macronutrient     composition. Based on prior genetic studies evaluating the body's physiological responses to     dietary carbohydrates or fats, the investigators identified multi-locus genotype patterns     with SNPs from three genes (FABP2, PPARG, and ADRB2): a low carbohydrate-responsive genotype     (LCG) and a low fat-responsive genotype (LFG). In a preliminary, retrospective study (using     the A TO Z weight loss study data), the investigators observed a 3-fold difference in     12-month weight loss for initially overweight women who were determined to have been     appropriately matched vs. mismatched to a low carbohydrate (Low Carb) or low fat (Low Fat)     diet based on their multi-locus genotype pattern. The primary objective of this study is to     confirm and expand on the preliminary results and determine if weight loss success can be     increased if the dietary approach (Low Carb vs. Low Fat) is appropriately matched to an     individual' s genetic predisposition (Low Carb Genotype vs. Low Fat Genotype) toward those     diets.   "
111492|NCT01826578|"     This study is about the evaluation of which benefits single port laparoscopic myomectomy has     in the perspective of cosmetics and patient satisfaction.   "
111493|NCT01826565|"     To evaluate the efficacy of rotational technique in the insertion of i-gel   "
111494|NCT01826552|"     The purpose of this multicenter, randomized, open label, parallel arm study whether the     newest 3rd generation stent - Orsiro hybrid sirolimus-eluting stent is noninferior to the     newest 2nd generation stent - Resolute Integrity zotarolimus-eluting stent in terms of 9     months in-stent late lumen loss. 345 Korean patients with a wide variety of coronary heart     disease will be enrolled to this all-comers trial to give definite answer to the above     hypothesis that is urgently needed.   "
111495|NCT01826539|"     As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the     dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two     donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.   "
111496|NCT01826526|"     The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than     saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream     infections in patients with home parenteral nutrition.   "
111497|NCT01826513|"     The purpose of this study is to assess the efficacy and user preference of the Newport     AutoSet for Her in female obstructive sleep apnea (OSA) patients.      Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen     desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.      User preference will be evaluated by subjective feedback relating to comfort, ease of falling     asleep, sleep disturbance and feeling of being refreshed.   "
111498|NCT01826500|"     The five proteins of the ITI (Inter-α-trypsin inhibitor) family, are essential components of     the extracellular matrix, the dynamics of which they participate in the processes of cellular     differentiation and proliferation. I. The ITIH1, ITIH2, ITIH3 and ITIH4 genes seem to be     overwhelmingly expressed in the liver, this organ secreting then the corresponding proteins     in the general circulation. The only data on ITIH5 indicate that this gene is poorly     expressed in the liver and that the major source of its expression is the placenta. In the     context of genetic studies on the syndrome of Mayer-Rokitansky-Küster-Hauser (congenital     aplasia of the uterus and vagina), the investigators have shown the involvement of ITIH5 and     implemented validation experiments of this gene in mice. The investigators have shown that     the production of ITIH5 by the uterus varies greatly depending on the physiological state of     this organ, especially during pregnancy and the estrous cycle. The investigators also found     that most of the production ITIH5 was located in the uterus. Therefore, the serum dosage of     ITIH5 could be used clinically as a new biological marker specific to the uterus. This     non-invasive biological marker could thus assist in the diagnosis and the understanding of     uterine pathologies. ITIH5 rate being correlated to endometrial proliferation, its dosage     could be an early and non-invasive marker of endometriosis. The peak of production of ITIH5     by the uterus at the time of embryo implantation window indicates that the assay could     provide a better assessment of endometrial receptivity to embryo. It then could be a hand     tool of diagnosis in some cases of early repeated miscarriages, and secondly, a prognostic     tool for embryo implantation in the context of in vitro fertilization.      The investigators conducted an initial feasibility study on the serum dosage of ITIH5, which     was approved by the ethics committee of the University Hospital of Rennes. This first step     has been validated. Now, the project is to perform a quantitative analysis of ITIH5 and to     correlate clinical and biological data of relevant pathological and physiological situations.     This project was the subject of a national and international patents of which the University     Hospital of Rennes is promoter.   "
111499|NCT01826487|"     Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which     develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is     important for maintaining normal muscle structure and function. Loss of dystrophin causes     muscle fragility that leads to weakness and loss of walking ability. A specific type of     mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy     in approximately 10-15% of boys with the disease. Ataluren is an orally delivered,     investigational drug that has the potential to overcome the effects of the nonsense mutation.     The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability.     The effect of ataluren on physical function, quality of life, and activities of daily living     will be evaluated. This study will also provide additional information on the long-term     safety of ataluren.   "
111500|NCT01826474|"     The purpose of the study is to see whether PRO045 is safe and effective to use as medication     for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 45 in the DNA     for the dystrophin protein.   "
111501|NCT01826461|"     This study will compare the safety and efficacy of three test article foams (PDI-192 0.1%     Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be     selected for future development.   "
111502|NCT01826448|"     The purpose of this research study is to test the safety of an investigational new drug     called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose     levels. Vemurafenib has been approved by the United States Food and Drug Administration     (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of     unresectable or metastatic melanoma.   "
111503|NCT01826435|"     The study team is proposing a single arm intervention to test the effect of an electronic     intervention on medication use among individuals with a prescription for hypertension/high     blood pressure. The investigator proposes that technology like text messaging, email, web     applications and mobile apps with proven, nurse intervention scripts, will lead to     significant, cost-effective improvements in hypertension medication use.   "
111504|NCT01826422|"     The purpose of this study is to evaluate the effect of the supplement with docosahexaenoic     fatty acid and eicosapentaenoic fatty acid for six months in the inflammation states as well     as the process of muscular regeneration and the metabolic disorders like obesity and insulin     resistance on patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy     (DMB) compared to those receiving placebo.   "
111505|NCT01826409|"     This study was conducted to investigate the effects of daily supplementation of fermented red     ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2     diabetes.   "
111506|NCT01826396|"     In the current treatment of colon cancer, the definition of locally advanced colon cancer     (LACC) is controversial, and the clinical trial evidence which support treatment for LACC is     not clear. Irinotecan (CPT-11) combined with fluoropyrimidine (5FU, capecitabine) is main     chemotherapy regimen for patients with advanced colorectal cancer. Whether this regimen also     could be effectively applied for patients with locally advanced colon cancer? It is worthy of     clinicians to conduct research. In recent studies, the literature indicated that the the     uridine diphosphate glucuronide transfer enzyme (UGT1A1) is an important metabolic enzymes     associated with drug metabolism of CPT-11. The gene polymorphism of UGT1A1 is related to     delayed diarrhea and neutropenia caused by irinotecan. Irinotecan dose-exploration study     found that the maximum tolerated dose for irinotecan in patients with UGT1A1*28 homozygous     variant genotypes was significantly lower compared with the wild genotype. The studies based     on Asian patients suggested that the gene variant of UGT1A1*6 also have similar impacts. At     present, the studies of irinotecan dose adjustment based on the UGT1A1 gene polymorphisms has     not yet come to the consistency of conclusions. The frequency of UGT1A1 gene polymorphisms     between different races is significant different, irinotecan dose exploratory study based on     Chinese patients has not been carried out.      This study focus on prospectively adverse reactions, optimal efficacy and R0 resection rate     of the patients with LACC who treated by dose-adjusted irinotecan based on the genotypes of     UGT1A1.   "
111507|NCT01826383|"     This study sets out to compare the effectiveness of a parent pain management coaching video     that is 5-minutes in length. The investigators will be comparing an active-video to a     placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month     infants undergoing routine immunization. The investigators hypothesize the active video will     result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase     in the parental use of distraction, physical comfort, and rocking.   "
111508|NCT01826370|"     This is a prospective, non-interventional, open label, multi center, post marketing     surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin     among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24     weeks.   "
111582|NCT01825395|"     To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with     Lambert-Eaton myasthenic syndrome (LEMS).   "
111677|NCT01824420|"     To investigate if oxybutynin ER adding on antimuscarinics is more effective than     mono-antimuscarinic treatment for patients with refractory OAB   "
111509|NCT01826357|"     The metabolic syndrome (MetS) is a cluster of clinical indices that signals increased risk     for cardiovascular disease and Type 2 diabetes. Women with polycystic ovary syndrome (PCOS)     were associated with MetS and insulin resistance. Cluster analysis was a useful tool for     identifying groups of women sharing similar metabolic risk factor patterns. Oligomenorrhea,     hyperandrogenism and polycystic ovary morphology were the three major components of PCOS.     Obesity is a main risk factor in metabolic syndrome. the investigators are interesting to     evaluate the relationship between risk of metabolic syndrome and their clinical and/or     biochemical characteristics in women with reproductive age.      Design: Retrospective study; medical records reviewed. Participants and setting: The     investigators retrospectively reviewed the medical records of female patients who visited our     Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.   "
111510|NCT01826344|"     This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1     year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and     effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a     short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion     of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated     Stent Graft and for whom a customised medical device is required.   "
111511|NCT01826331|"     One of the most important debates in the field of disease prevention is whether financial     incentives should be contingent on participation in evidence-based programs for smoking     cessation or on actual outcomes, like prolonged abstinence. This study can fill a major     knowledge gap in this debate, which is the lack of any population trial that compared the     impacts of outcomes- and participation-based incentives in a population of smokers. This     research can help policy makers and health service providers choose the incentives approach     that provides the most effectiveness, cost-effectiveness and cost-savings for entire     populations of smokers.   "
111512|NCT01826318|"     This study assessed the impact of a task-focusing strategy on perceived stress levels and     performance during a simulated CPR scenario.   "
111513|NCT01826305|"     In this study we plan to compare the efficacy of independent exercises performed by the     patients at home to formal rehabilitation therapy following primary total knee replacement.     Patients will be randomized to these two cohorts at enrollment into the study and followed     prospectively. Patients randomized to the formal rehabilitation cohort will receive a     prescription for therapy for twelve weeks. Patients randomized to the independent exercise     cohort will receive online access to a twelve-week protocol of exercises to perform at home     to strengthen and improve function of the replaced joint.      At enrollment, a baseline evaluation will be conducted to capture demographics, height,     weight, primary diagnosis, medical comorbidities, and social supports as well as completion     of the selected outcome measure, American Knee Society (AKS) Score, Knee and Osteoarthritis     Outcome Score (KOOS). Secondary outcomes will include the measurement of health status with     use of the Short Form-12v2 (SF-12v2) and activity level with the University of California,     Los Angeles (UCLA) Activity Score. At the twelve-week, six-month and twelve-month follow-up     visits, the study subjects will complete the KOOS, SF-12v2, and UCLA Activity Score     questionnaires. Statistical analysis will be performed to compare the outcomes between the     two cohorts.      Hypothesis:      There will be no difference in outcomes between formal rehabilitation and independent     exercises at twelve months after primary total knee replacement surgery using the American     Knee Society (AKS) Knee Score.   "
111514|NCT01826292|"     The investigators are conducting a retrospective, cross-sectional chart review of patients     who underwent an anesthetic administered by an anesthesiologist in the University of     California Davis main operating rooms and were transferred to the main post anesthesia care     unit between January 1, 2012 and March 31, 2012. The investigators are excluding patients     less than 18 years of age, patients transferred to the intensive care unit, and patients for     whom data is not reported. Our aim is to report the incidences patient characteristics, as     well as anesthetic and surgical techniques, and the associations these factors may have with     the outcome of patient length of stay in the PACU.   "
111515|NCT01826279|"     The purpose of this study is to investigate potential metabolic effects of resveratrol in     morbidly obese women undergoing gastric bypass surgery.      The investigators hypothesize that resveratrol will:        -  Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion        -  Decrease hepatic and adipose tissue VLDL-TG uptake        -  Increase insulin sensitivity      The investigators will look at changes in:        -  Lipid turnover (VLDL-TG kinetics, palmitate kinetics,calorimetry)        -  VLDL-TG uptake in different tissues (subcutaneous femoral adipose tissue, subcutaneous          abdominal adipose tissue, visceral adipose tissue and liver tissue)        -  Insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)        -  Regulation of liver fat handling        -  Lipoprotein lipase activity and fat cell size (abdominal and femoral adipose tissue)   "
111516|NCT01826266|"     PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable     safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977     that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care     prothrombin time [PoC-PT]), and/or secondary biomarkers (thromboelastography reaction time     [TEG-R]) will be identified.   "
111517|NCT01826253|"     Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output     monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which     consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The     maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was     too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion     conducted for cardiac output maximalization, following actual guidelines.   "
111518|NCT01826240|"     The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT)     + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine     its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is     to collect data on the cognitive changes underlying treatment gains.   "
111519|NCT01826227|"     The purpose of this study is to see if Positron Emission Tomography (PET) probes make it     easier for your surgeon to find cancer and remove it during your surgery. A PET probe is a     wandlike device that can detect radioactivity.   "
111524|NCT01826162|"     Gut microbiota is being increasingly recognized as an important factor in fat distribution,     insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota     could play an important role in the development of obesity and type 2 diabetes mellitus. The     role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by     microbial fermentation of fibre, is still controversial. At the present time, our     understanding of the effects of SCFA on human metabolism (in gut or systemically) is still     limited. The investigators hypothesize that the differential availability of SCFA impacts     human metabolism differently.      In this placebo controlled, double-blind, randomized crossover pilot study the investigators     will validate in overweight/obese healthy male volunteers whether rectal administration of     SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be     investigated if site of administration (in distal or proximal colon) of SCFA differentially     affects parameters of substrate and energy metabolism and to test the duration of short-term     effects of SCFA administration.   "
111525|NCT01826149|"     The purpose of this study is primarily to determine the effects of propofol at different     concentration on the mitral valve annulus by using Tissue Doppler Imaging   "
111526|NCT01826136|"     Postoperative airway clearance and recovery of pulmonary function after lung resection is     critical in patients undergoing pulmonary resection surgery. The investigators hypothesized     that vibratory positive expiratory pressure using the Acapella device may improve pulmonary     function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.   "
111527|NCT01826123|"     Recently, the investigators study group showed in a mono center study that Point of Care     (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in     perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify     the obtained results by conducting this multicenter study.   "
111528|NCT01826110|"     The purpose of this study is to investigate the radiotracer [11C] PIB in participants with     probably Alzheimer's Disease (AD) and healthy age-matched controls.   "
111529|NCT01826097|"     Can a commercially available vibrating chair increase the number of urothelial cells in a     urine sample of healthy participants non-invasively? The investigators plan is participants     will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting     in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking     eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour.     Then, urine samples will be collected and examined for urothelial cell concentration for both     groups.   "
111530|NCT01826071|"     The purpose of this study is to compare three different treatments for these types of lower     extremity apophysitis- Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome     (SLJ), or Sever's disease.      The investigators hypothesize that adolescents who perform a home exercise program (HEP)     consisting of active elongation exercises will have decreased pain and earlier return to     sports and activities as compared to those who perform a HEP that consists of static     stretching exercises or those who use symptomatic treatment with ice, acetaminophen or NSAIDs     and activity modification.   "
111531|NCT01826058|"     Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that     requires to be treated promptly. Although direct decompressive surgery is the most effective     treatment, surgery is only used in selected patients because most patients have a poor     overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most     commonly used for patients with MESCC, but conventional RT alone can achieve modest     neurologic outcomes.      The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid     decompression of epidural mass, durable local control and subsequently improved neurologic     outcomes compared to conventional RT are expected when MESCC is treated with SBRT.   "
111532|NCT01826045|"     The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma     Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).   "
111533|NCT01826032|"     In the near future more than 20% of the European population will be over 65 years old and the     prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher     than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the     relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly     has scarcely been observed.      The aim of this study is to investigate cognitive performance in elderly OSA patients, the     corresponding brain morphology changes and biological markers and their reversibility with     continuous positive airway pressure (CPAP) treatment.   "
111534|NCT01826019|"     The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and evaluate     an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk     assessment, treatment and control involving: (1) simplified algorithms implemented by     non-physician health workers (NPHW) and supported by e-health technologies (tablets     programmed with decision and counselling support software); (2) initiation of evidence-based     cardiovascular (CV) medications and (3) treatment supporters to optimize long-term medication     and lifestyle adherence.   "
111535|NCT01826006|"     The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in     acute myocardial infarction is described in up to 40% of cases. This event is associated with     a worse prognosis at follow up and an unfavourable left ventricular remodelling. Two main     pathogenetic mechanisms cause no-reflow: distal embolization, ischemia-reperfusion injury and     individual susceptibility. In such a context, Excimer Laser (EL) may play an important role     in order to reduce the rate of microvascular obstruction.      Thus, in this randomized study we will assess the effect of EL versus Manual Thrombus     Aspiration for ST elevation MI using ST segment resolution on standard 12 leads ECG as     primary endpoint of myocardial reperfusion.   "
111536|NCT01825993|"     The investigators would study the control of postoperative pain with peridural catheter,     morphine PCA ev or Transabdominal block.   "
111537|NCT01825980|"     To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability     of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.   "
111538|NCT01825967|"     The management of acute diverticulitis maybe better if we have prognostic markers of     evolution.      Hypothesis: C-reactive protein maybe a good prognostic marker of evolution of acute     diverticulitis.      The investigators need to know the values of C-reactive protein to predict evolution of acute     diverticulitis.   "
111539|NCT01825954|"     The purpose of this study is to test the safety and efficacy of a noninvasive cortical     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical     Electrostimulation (RINCE) in the management of fibromyalgia. Patients who meet the 1990     American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE     treatments delivered by a medical device called NeuroPoint. Approximately 45 fibromyalgia     patients will be randomized into one of three study groups. One of these groups will receive     sham treatment, meaning they will receive no treatment at all, while the remaining two groups     will receive different amounts of RINCE therapy. The study's primary outcome measure will be     the patient's change from baseline in self-reported 24-hour average pain intensity. The     study's hypothesis is that there will be a difference between treatment groups in primary     outcome measure.   "
111540|NCT01825941|"     Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite     the fact that data supporting this practice do not exist. The investigators propose a     randomized double blind study to test the hypothesis that 50mg of intravenous     diphenhydramine, when added to standard migraine therapy, will result in a greater rate of     sustained headache relief than standard migraine therapy alone. For this study, standard     migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is     defined as achieving a headache level of mild or none within two hours and maintaining a     level of mild or none for 48 hours. Patients who present to the Montefiore emergency room     (Bronx, NY) with an acute migraine will be approached for participation. They will be     screened for medication contra-indications and non-migraine etiologies of headache. The study     will be randomized. Assignment will be concealed. Participants and researchers will be     blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours     in the ED and by telephone 48 hours after medication administration. A sample size     calculation, based on pilot data, revealed the need for 374 participants. An interim analysis     will be performed after 200 participants have been enrolled with the goal of assessing for     lack of conditional power.   "
111541|NCT01825928|"     Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for     methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have     effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors     neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among     methamphetamine addicts.   "
111542|NCT01825915|"     Observational studies suggest faster recovery and quicker return to normal activities     following laparoscopic supracervical hysterectomy (LSH which involves removal of the body of     the womb but conservation of the neck of the womb or cervix) compared with laparoscopic     hysterectomy (LH in which both the body and neck of the womb are removed) in women with     benign uterine disease. Data from the only randomised controlled trial (RCT) on the topic     does not support this observation.      The investigators set out to investigate the feasibility of a double blind RCT comparing     post-operative recovery following LH with that following LSH.      The investigators set out to recruit 50 participants from a single gynaecological surgeon's     caseload. Web based randomisation was carried out at the time of study laparoscopy. Surgery     was performed using a standardised technique.      Participants and the data handler were blinded to treatment allocation (double blind study     where neither the patient nor the surgeon have knowledge of treatment group allocation at the     time of questionnaire analysis).      Primary outcome is feasibility of recruitment to the study. The null hypothesis for this     study is that 'a double blind, randomised controlled comparison of recovery following     laparoscopic hysterectomy with recovery following laparoscopic sub-total hysterectomy' is not     feasible.      Secondary outcomes included validated post-operative recovery and mood questionnaires at     baseline, prior to discharge and at weekly intervals for 12 weeks. Validated questionnaires     regarding pelvic floor function and sexual function will be assessed at baseline, 6 weeks and     6 months.      The findings of the feasibility study will inform the power calculation for a planned     definitive study ( the magnitude of the differences found between the 2 arms of the     feasibility study will allow calculation of the total number of participants required in a     definitive study to allow demonstration of statistically significant differences in     outcomes).   "
111543|NCT01825902|"     This pilot trial studies fluorine F 18 fluorothymidine (18F-FLT) positron emission tomography     and diffusion-weighted magnetic resonance imaging in planing surgery and radiation therapy     and measuring response in patients with newly diagnosed Ewing sarcoma. Comparing results of     diagnostic procedures done before and after treatment may help doctors predict a patient's     response and help plan the best treatment.   "
111544|NCT01825889|"     The purpose of this study is to measure how much of the study drug, evacetrapib, gets into     the blood stream and how long it takes the body to get rid of it when given to participants     with severe renal (kidney) impairment compared to participants with normal renal (kidney)     function. This study will last approximately 8 weeks.   "
111545|NCT01825876|"     All study participants will receive both warfarin and a study drug called evacetrapib. The     main purpose of this study is to look at how much warfarin gets into the blood stream and how     long it takes the body to get rid of warfarin when given both with and without evacetrapib.     Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots     when given with evacetrapib by measuring the time it takes for blood to clot and comparing it     to an average of the international normalized ratio (INR). INR measures the time it takes for     blood to clot and compares it to an average.      The study will last approximately 5 weeks, not including screening.   "
111546|NCT01825863|"     Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years     old. Ten percent of the population will get this disease during a lifetime. At Bispebjerg     hospital it is one of the most common acute surgeries performed. Though at Bispebjerg     hospital the surgery is only performed on adults as there is no pediatric ward. The surgical     technique is primarily laparoscopic surgery, where the patients have their appendix removed     while in general anaesthesia. During the last three years Bispebjerg hospital has had an     average of 287 patients per year undergoing laparoscopic surgery. From January to the     September 2012 a total of 211 patients have had the operation, with 29% having the operation     performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only     performed in cases where laparoscopic surgery is impossible, this is often due to adhesions,     scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery     are usually smaller than that from an open appendectomy, but it gives the patient three     smaller scars divided on three abdominal quadrants instead of one larger scar on one     quadrant.      The investigators want to conduct a clinical trial with fifty six patients undergoing     laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is     possible to improve the post-operative pain management within this very large group of     patients undergoing acute surgery. In detail, the investigators wish to explore whether the     use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery     due to acute appendicitis, can anesthetize the patients completely or partially, so they can     avoid morphine intake completely or partially during the post-operative phase (12-24 hours).     The research project will be a randomized, double-blinded, controlled clinical trial.   "
111547|NCT01825850|"     The objective of the study is to investigate the drug interaction between Gemigliptin and     Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered     concomitantly and each alone in healthy male subjects.   "
111951|NCT01820559|"     This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study     to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic     treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1     ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.   "
111549|NCT01825824|"     The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic     resection or liver transplantation, but less than 20% of HCC patients are suitable for     surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial     chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete     response and commonly develops recurrence. Recently several small studies reported high tumor     response and local control rate after stereotactic ablative radiotherapy (SABR) alone or with     TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3 fractionations     for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.   "
111550|NCT01825811|"     The purpose of this study is to determine whether TissueGene-C, allogeneic human chondrocytes     expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue is effective and safe     in patients with degenerative arthritis.   "
111551|NCT01825798|"     The purpose of this study is to determine whether metformin is safe and effective in the     treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who     are currently taking atypical antipsychotic medication.   "
111552|NCT01825785|"     This multicenter, randomized, double-blind, placebo-controlled, ascending multiple dose study     assesses the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous     administration of 6 doses of 1 mg/kg AMG 785 once every 2 weeks or 3 doses of 3 mg/kg AMG 785     every 4 weeks in healthy men or postmenopausal women with low bone mass and 3 doses of 2     mg/kg AMG 785 every 4 weeks or 6 doses of 2 mg/kg AMG 785 every 2 weeks in healthy     postmenopausal women with low bone mass.   "
111553|NCT01825772|"     900 subjects having received dental implants 9-10 years ago are invited for a clinical and     radiographic examination. The individuals were randomly selected from the National Health     Insurance data register in Sweden.      The clinical and radiographic examination of the 900 selected subjects will include     assessments of implant loss, loss of prosthesis and technical / biological complications.      Biological complications will be assessed from the findings in the clinical and radiographic     examinations. Thus, signs of pathology in peri-implant tissues, probing pocket depth (PPD)     and bleeding/pus on probing (BoP) will be recorded. Marginal bone loss and other findings in     radiographs will also be evaluated.      The prevalence, extent and severity of peri-implantitis will hereby be determined.     Patient-centered outcomes will also be obtained.   "
111554|NCT01825759|"     The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and     artery structure and function in patients with hypertension   "
111555|NCT01825746|"     The purpose of this delayed cluster randomized intervention trial is to evaluate primary care     strategies to increase goal setting, shared decision-making and evidence-based support and     counseling for health behaviors and psychosocial issues through the implementation of a     standard set of practical, patient-centered survey items and related decision support tools,     called the My Own Health Report (MOHR) assessment. Nine pairs of diverse primary care     practices will participate, four pairs of federally qualified health centers clinics and 5     pairs of practice based research network practices. Practice pairs are similar in size,     patient and staff mix, culture, and level of EHR integration. Within pairs, practices will be     randomized to early or delayed intervention (4 months later). The intervention consists of     implementing the MOHR assessment and patient counseling into clinical care for all patients     presenting for wellness or chronic care during a 6 month study period. Prior to     implementation, practices will receive brief training about health behavior counseling, goal     setting, and action planning. Practices will also be provided materials to support     evidence-based counseling and referrals to local community resources. MOHR assessment     implementation details will be determined by each practice pair but will generally include     (1) asking patients to complete the MOHR assessment on the web prior to encounters (available     at www.MyOwnHealthReport.org it addresses10 distinct health behaviors and psychosocial issues     including physical activity, diet, alcohol consumption, tobacco use, drug use, sleep, stress,     depression and anxiety), (2) provision, via the tool, immediate patient feedback that     includes identification of unhealthy issues, assessment of readiness to change,     prioritization of issues to change, and preparation for goal-setting and action planning, (3)     feedback to the primary care team on the patient status and priorities for change, (4)     provision of counseling, goal setting, and referrals to local resources by clinicians during     the subsequent office visit, and (5) follow-up with the clinicians and local resources as     agreed upon by the patient and clinician. Data sources will include patient responses to the     MOHR assessment, practice appointment records, and a patient experience survey mailed to the     first 300 patients offered the MOHR assessment two weeks after their office visit. Primary     outcomes will include the Reach and Effectiveness of the intervention. Reach will be assessed     in early and delayed intervention sites when they field the MOHR assessment. Effectiveness     will compare early and delayed intervention sites during the early intervention phase,     allowing the delayed intervention sites to serve as controls. Reach outcomes will include the     percent of eligible patients receiving and completing the MOHR assessment. Effectiveness     outcomes will include the percent of patients reporting that they were asked about health     topics, set a change goal, received assistance for making a change, were referred for local     counseling and support, and/or made any changes. Additional outcomes will include maintenance     of the MOHR assessment implementation beyond 4 months, changes in patient reported health     behavior and psychosocial measures by repeated administration of the MOHR assessment 4 months     after initial completion, qualitative assessments on implementation factors and context that     influence outcomes, and cost, in terms of time and resources required for practices to     implement the MOHR assessment.   "
111556|NCT01825733|"     Postoperative pain, the great concern for the patients undergoing spine surgery, has led to     common use of opioid-based intravenous patient-controlled analgesia (IV-PCA) postoperatively.     Opioid-based IV-PCA offers better pain control, which could facilitate early recovery,     rehabilitation and increase patient satisfaction. However, its use inevitably increases the     incidence of postoperative nausea and vomiting (PONV), another great discomfort, as high as     80% in patients with multiple risk factors.Therefore, there have been consistent efforts to     prevent PONV with multimodal therapies such as risk stratification, modification and     preventive use of antiemetics.      Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most     commonly used and extensively studied to reduce PONV because of its efficacy and fewer side     effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated     with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy     between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and palonosetron.     Ramosetron is known to have a higher affinity and longer duration of binding to 5-HT3     receptor, therefore exhibits potent and sustained anti-emetic effect than previously     developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the 5-HT3     receptor, which brings a higher affinity, longer duration of action and longer elimination     half-time.According to the previous studies, both ramosetron and palonosetron showed superior     antiemetic efficacy for PONV associated with opioid-based IV-PCA to ondansetron as expected     by their theoretical advantages. However, it has never been evaluated which one has superior     antiemetic efficacy for opioid-based IV-PCA associated PONV. Therefore, in this study, we     tried to evaluate the relative antiemetic efficacy of ramosetron and palonosetron in     controlling opioid-based IV-PCA related PONV.   "
111557|NCT01825720|"     Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to     be associated with hemodynamic instability, organ dysfunction and increased postoperative     morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an     adjuvant therapy in patients with myocardial infarction or in the patients undergoing     valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known     to prevent excretion of lactate and to increase the extraction of lactate after reperfusion     with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury     of myocardium after CPB, to improve myocardial contractility, insulin resistance and     hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to     the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.   "
111558|NCT01825707|"     The purpose of this study is to determine the absorption, metabolism, and excretion (AME)     kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine,     and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi)     administered as a single oral dose.   "
111559|NCT01825694|"     This study plans to develop an integrated treatment for comorbid post-traumatic stress     disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a     treatment approach that is community-friendly, well-tolerated, and deliverable by substance     abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse     Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The     investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral     Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to     assess the acceptability and feasibility of the integrated approach; and to pilot test the     new program against standard care.      The investigators hypothesize that the intervention group, compared to the control group,     will reduce substance use and symptoms for traumatic stress.   "
111583|NCT01825382|"     The goal of this prospective pilot study is to evaluate the use of remote technology (iBGStar     in combination with Diabetes Manager App on iPhone) to patient related outcomes, and a     hypoglycemia fear questionnaire. In the future, this study might lead to investigating the     role of social media with mobile phones in Type 1 Diabetes (T1D) care. Moreover, the number     of patients with T1D continues to increase, and such technology could conceivably help     compensate for the shortages of endocrinologists providing care.   "
111840|NCT01822041|"     This is study in healthy human volunteers to determine the absorption, metabolism, and     excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).   "
119697|NCT01719172|"     The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used     during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be     used.   "
111560|NCT01825681|"     Life Enhancing Activities for Family Caregivers is a six-week program designed to increase     positive affect in people who care for a family member with dementia. The intervention     consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to     teach simple skills that are practiced at home in a study-supplied workbook. The program is     preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be     conducted at 1-month, 3-months, and 6-months post intervention.      Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate     significantly greater improvements in psychological outcomes and will engage in more problem     focused and positive appraisal forms of coping compared to the wait-list control condition.   "
111561|NCT01825668|"     The overall goal of this clinical study is to investigate how dietary cholesterol intake     influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol     metabolism between adults who had been breast-fed as infants as a function of the duration of     breast feeding and quantity of early cholesterol intake. The study also aims to evaluate the     effect of a plant sterol formulation in low fat milk shake in modulating the lipid profile     favorably in the study population.   "
111562|NCT01825655|"     The purpose of this study is determine if long acting antihistamine like cetirizine can help     with itching induced by opioid pain medications.   "
111563|NCT01825642|"     Surgical removal of the prostate (radical prostatectomy) is a common and generally effective     treatment for prostate cancer. However, standard prostatectomy can affect urinary continence     and sexual function. Different surgical techniques, such as nerve-sparing prostatectomy and     seminal vesicle-sparing prostatectomy, may limit these treatment-related effects. In a     standard prostatectomy, the seminal vesicles are removed completely. In contrast, during a     seminal vesicle-sparing prostatectomy, the surgeon leaves a portion of the seminal vesicles     intact. This is done because the nerves that are important to urinary continence and erectile     function are located close to the seminal vesicles. The purpose of this study is to determine     whether patients who undergo nerve-sparing prostatectomy with seminal vesicle-sparing     experience better urinary and sexual functioning after surgery than patients who undergo     standard nerve-sparing prostatectomy.   "
111564|NCT01825629|"     The purpose of this study is to determine the efficacy of a multidisciplinary therapy with     physical, manual and deontology therapies in the treatment of temporomandibular joint     dysfunction in patients with fibromyalgia syndrome.   "
111565|NCT01825616|"     Hypothesis: Six weeks of supplementation with vitamin D (4000 IU/day) using Dole's Vitamin D     Portobello Mushroom Powder will increase winter serum vitamin D levels, and improve muscle     function and strength, and innate immunity (granulocyte/monocyte phagocytosis and oxidative     burst activity), and attenuate exercise-induced muscle damage and DOMS.   "
111566|NCT01825603|"     This phase I trial studies the side effects and best dose of ADH-1 when given together with     gemcitabine hydrochloride and cisplatin in treating patients with metastatic pancreatic or     biliary tract cancer that cannot be removed by surgery. ADH-1 may stop the growth of cancer     cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine     hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells or by stopping them from dividing. Giving ADH-1 together with     gemcitabine hydrochloride and cisplatin may kill more tumor cells.   "
111567|NCT01825590|"     A difference between dialysate and serum sodium concentration leads to diffusive sodium     transfer across the dialyzer membrane. The consequences of diffusive sodium flux into the     patient can be chronic sodium overload leading to overhydration, hypertension, cardiovascular     disease, and other problems. Diffusive sodium flux out of the patient can lead to     intradialytic blood pressure instability. A simple strategy for alignment of dialysate and     serum sodium concentrations was implemented starting in April/May 2010 in order to minimize     the problems particularly associated with chronic sodium overload.   "
111568|NCT01825577|"     Falls in the elderly are a very common and serious health problem with devastating     consequences. Those with dementia are 5 times more likely to experience falls than older     people without significant cognitive impairment. Despite a growing awareness and the use of     available treatments, the number of falls and fall related injuries continue to increase. It     is important to develop more effective treatments to help reduce the number of falls and     prevent injury. The assessments used in this study determine fall risk which predicts the     likelihood of falls in the future.      This study will evaluate the possible role of Methylphenidate, Ritalin, in preventing falls     and improving symptoms of apathy, or indifference. Methylphenidate is FDA approved for the     treatment of ADHD but is not currently approved by the FDA for preventing falls or improving     apathy(lack of interest) in the elderly. The methylphenidate used in this study will be     absorbed through the skin by wearing a small patch near the hip area.      The specific primary aim of this open label study is to determine if use of transdermal     Methylphenidate (t-MPH) causes a reduction in fall risk in patients with dementia.      The hypotheses to be tested is that after receiving t-MPH for 4 weeks, subjects will show     improvement in gait and mobility assessment scores when compared to gait and mobility scores     at screening.   "
111569|NCT01825564|"     Replacing a G tube and placing feeding tubes is standard in the Emergency Department (ED) and     ICU, respectively. However placement requires a chest or abdominal x-ray to confirm correct     position. The investigators are testing the accuracy of the FDA approved devices RightSpot pH     Indicator & RightLevel pH Detector in determining correct position based upon pH which will     then be correlated with the standard of care x-ray.   "
111570|NCT01825551|"     The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor     (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.   "
111571|NCT01825538|"     To understand current practices of pulmonary physicians in relation to Advanced Care Planning     (ACP) in order to develop future disease-specific tools that will improve patient-physician     communication about ACP.   "
111618|NCT01824927|"     Patients having cataract extraction in the second eye under topical anesthesia with monitored     anesthesia care often report increased pain and awareness relative to the first surgery in     the fellow eye, despite similar operative and anesthetic conditions. The purpose of this     study is to investigate the pathogenesis of this phenomenon.   "
111952|NCT01820546|"     In multiple myeloma cancer stem cells can be defined and quantified with flow cytometry.     More, these cells can be related to treatment response.   "
111572|NCT01825525|"     The Olympus ScopeGuide® is a useful tool in speeding up colonoscopy and making it less     painful for patients. It is currently contraindicated by the manufacturer for use with     patients with implantable electronic devices (such as cardiac pacemakers). There is no     evidence to back up this contraindication and with the number of pacemakers being inserted     increasing by around 30 000 annually in the UK, more patients will be denied the use of this     device should they require a colonoscopy.      Participants with Pacemakers or Implantable Cardioverter Defibrillators will attend their     check appointment. Following this they will be asked to lie with a colonoscope connected to     the ScopeGuide® placed onto their abdomen (with clothes on) for 2 minutes. During this time     they will be monitored for any irregular cardiac activity which may indicate electromagnetic     interference. After this a second device check will occur and the participant will be sent     home.      The hypothesis is that the ScopeGuide will not interfere with the cardiac devices.   "
111573|NCT01825512|"     Haemoglobinopathies are a group of inherited disorders characterized by structural variations     of the haemoglobin molecule. Most of the patients affected require for survival chronic red     blood cells transfusions to overcome ineffective erythropoiesis. Unfortunately, all     chronically transfused patients become clinically iron overloaded as there is no     physiological mechanism for the removal of iron from the body. The pathologic changes and     clinical manifestations associated to chronic iron overload are common among all     transfusional iron-overload patients, albeit best documented in patients with     beta-thalassemia major. The recommended treatment consists in regular blood transfusions     combined with chelating therapy to remove the harmful iron accumulation in the body.      Currently, in the clinical practice particularly in children and adolescents, the criteria     leading to the choice of the chelating agent include also the adherence to therapy, thus     favouring the use of oral chelators (Ceci A et al., 2011) DFP (Deferiprone) was the first     oral chelator authorised in Europe in 1999 as second line treatment for the treatment of iron     overload in patients with thalassaemia major when DFO (Deferoxamine) is contraindicated or     inadequate. However, despite a wide experience of DFP with iron overloaded (specifically     thalassaemic )patients, limited data are available for younger children. For this reason the     need for additional data in younger children is expressively included in the 2009 PDCO     (Paediatric Committee) Priority List.      The purpose of this study is to assess the non-inferiority of DFP compared to DFX     (deferasirox)in paediatric patients affected by hereditary haemoglobinopathies requiring     chronic transfusions and chelation. Non inferiority will be established in terms of     percentage of patients successfully chelated, as assessed by serum ferritin levels (in all     patients) and cardiac MRI T2* (in patients above 10 years of age able to have an MRI scan     without sedation).   "
111574|NCT01825499|"     Vermont Oxford Network maintains a database for live born infants 401 to 1500 grams or 22 to     29 weeks gestational age who are born at participating hospitals or admitted to them within     28 days of birth, regardless of where the infant receives care.   "
111575|NCT01825486|"     Background: Accidental falls result in major physical and psychological morbidity in the     elderly, especially stroke patients. To get optimal prevention of stroke falls, it is crucial     to identify independent risk factors from multivariate analysis of related balance and gait     parameters.      Aim: To evaluate the effects of balance and gait characteristics in determining whether or     not accidental falls may happen. To investigate if the balance and gait parameters affect the     time from lesion to when (and if) patients suffer from falls. To compare differences of     balance and gait parameters in accidental fall patients between those with severe accidental     injuries and those without severe injuries.      Methods: The 2-year observational cohort study will enroll 706 elderly stroke patients, who     have not had a previous stroke. They will be retrieved from the Inpatient department and     followed-up regularly in the Outpatient department when they are discharged. All subjects     will be evaluated at 1 month and 6 months after stroke. These evaluations will include:     mental, cognition and depression status; lower-limb muscle strength assessed by a dynamometer     as well as range of motion of joints assessed by a biaxial electro-goniometry; functional     independence measure; balance and gait pattern will be assessed by both clinical observation     and objective laboratory examination (a dynamic posturography and computerized gait analysis     system); falls and fall-related injuries during the proceeding year. Differences in baseline     characteristics are tested by one-way ANOVA, Mann Whitney U or t tests, if appropriate. The     investigators will identify the independent risk factors of accidental falls with logistic     regression and use the log rank statistic of Kaplan-Meier survival curve to differentiate the     risk of accidental falls or fall-related injuries in different groups.   "
111576|NCT01825473|"     To evaluate the relationship of reflux and apnea and to determine whether the administration     of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or     desaturation events in a prospective randomized controlled trial.   "
111577|NCT01825460|"     The purpose of this study is to determine the short-term effects of a manual therapy protocol     on pain, disability and cervical range of motion in individuals with acute whiplash injury.   "
111578|NCT01825447|"     The main purpose of this study is to simulate if oxycodone and naltrexone combination     capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for     the purpose of getting high.   "
111579|NCT01825434|"     Background and aims:Constipation is a frequent complaint and the combination of a prebiotic     and probiotics would have a potentially synergic effect on the intestinal transit. The     present study therefore aims to investigate the combination of polydextrose (Litesse®), L.     acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who     suffer from constipation.      Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG)     and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14     days. Those in the CG received only yogurt, while the TG received yogurt containing     polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513).     Expect that patients who took a combination of polydextrose has a decrease in the colonic     transit time (CTT) when comparing initial and final transit time.   "
111580|NCT01825421|"     Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences     including development of necrotizing enterocolitis (a serious, potentially life-threatening     gastrointestinal illness in premature babies), late-onset infections, resistance to     antibiotics, increased length of hospital stay, and death.      Starting and continuing antibiotic therapy for blood culture-negative infections in the     neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying     from 20%-90% of infants undergoing a sepsis evaluation in the NICU.      While blood culture results are the gold standard, there is usually a delay of up to 48-72h     before the results are known. Hence, initiation and continuation of antibiotic treatment are     usually based on clinical evaluation and blood count criteria which do not possess high     specificity or sensitivity, and may be unreliable in the first few hours after birth or in     the early stages of infection.      Since the investigators found that neutrophil CD64 (a type of protein found on the surface of     a type of white blood cell that can be detected quickly in a very small amount of blood     sample) has high accuracy for early detection of blood culture-proven infections in newborn     babies, with extremely high negative predictive value (can identify babies definitively with     no infection), the investigators will use this test to decide whether to stop or continue     antibiotics in the NICU.      The investigators hypothesis is that neutrophil CD64 values can be safely used to discontinue     antibiotics in newborns suspected of having infections.      The investigators aims are to utilize sequential measurements of CD64 values to stop     antibiotics early in neonates being investigated for both early and late-onset infections in     the NICU.      This is a prospective, randomized, controlled (RCT) trial. The study population will be     derived from the sub-set of all newborn infants who have undergone investigations for     presence of infection in the NICU.   "
111953|NCT01820533|"     To study ownership and use of cell phones in low-income smokers. This may help us better     understand the impact of cell phone ownership plans on low income smokers' access to     quitlines. Use of quitlines may be impeded by limited access to landline phones and limited     airtime minutes on cell phones.   "
111584|NCT01825369|"     Infants with congenital heart disease and increased pulmonary blood flow have altered     carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment     will attenuate these alterations and improve clinical outcomes.      The investigators will pilot a trial assessing the safety and pharmacokinetics of     perioperative IV L-carnitine administration in these patients. To this end, a pilot clinical     trial is proposed. Infants with ventricular septal defects or atrioventricular septal defects     undergoing complete surgical repair will receive L-carnitine (25, 50, or 100 mg/kg, IV) just     prior to cardiopulmonary bypass (CPB) and 2hr after CPB. Carnitine levels will be measured     before CPB, and before and 0.5, 1.5, 3, 5, 9, 12, and 24h after the second dose. The safety,     pharmacokinetic profile, feasibility, and effect of L-carnitine administration on biochemical     parameters, as well as clinical outcomes will be determined. The investigators expect this     pilot to provide the data needed to proceed with a placebo-based randomized, controlled,     trial.   "
111585|NCT01825356|"     The purpose of this study is to determine whether patients undergoing a dorsal cheilectomy     procedure with implementation of amniotic membrane tissue results in improved clinical and     functional outcomes compared to a standard dorsal cheilectomy procedure.      Specific Aim 1:      To compare American Orthopedic Foot and Ankle Society (AOFAS) scores between patients     undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of     amniotic membrane tissue.      Hypothesis 1: Clinical and functional outcomes, as measured by the AOFAS , in the patients     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior     to those without.      Specific Aim 2:      To compare range of motion between patients undergoing dorsal cheilectomy to patients     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.      Hypothesis 2: Patient to undergo dorsal cheilectomy and implantation of amniotic membrane     tissue will demonstrate less postoperative stiffness as measured from the pre-and     postoperative radiographs.      Specific Aim 3:      To compare Foot Function Index (FFI) scores between patients undergoing dorsal cheilectomy to     patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.      Hypothesis 3: Clinical and functional outcomes, as measured by the FFI, the patients     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior     to those without.   "
111586|NCT01825343|"     Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical Centre     with injuries of all systems, major and minor, in order to determine the exact circumstances     of the injury, whether this might have been preventable and design a Haddon Matrix of risk     factors for injury to target prevention.      Hypothesis: injury prevention interventions can be targetted by finding out local causes of     Paediatric Trauma   "
111587|NCT01825330|"     The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The     NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.   "
111588|NCT01825317|"     Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer     for the treatment of Alzheimer patients.   "
111589|NCT01825304|"     Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory     transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung     injury/acute respiratory distress syndrome will appear. In the group of people who suffering     intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate     the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of     ALI/ARDS, which may decrease morbidity in this population.   "
111590|NCT01825291|"     The purpose of this study is to investigate the effectiveness of CPAP treatment to     co-morbidities of sleep apnea by looking the change of the consumption of medication of the     co-morbidities before and after starting the CPAP treatment.   "
111591|NCT01825278|"     This study proposes to evaluate the clinical applicability of the ExSpiron Respiratory Volume     Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) in obese surgical patients     undergoing general anesthesia. Previous work has demonstrated the ability of the ExSpiron     monitor to provide non-invasive, real-time, continuous measurements of respiratory parameters     such as tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in normal     weight patients but those studies did not specifically look at obese subjects. Respiratory     depression, in the postoperative setting due to residual anesthetics and/or opioid     administration, continues to be a significant cause of adverse outcomes. Obese patients are     at increased risk for respiratory complications. Currently, there is no objective measure of     early respiratory indicators for developing respiratory compromise. Current respiratory     assessment in non-intubated patients relies on oximetry data and subjective clinical     assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but     it is a late indicator of respiratory decline. There is no current device capable of giving     real time ventilatory information such as tidal volume and minute ventilation of a patient     that is not mechanically ventilated. The ExSpiron system utilizes an impedance based     technology and proprietary algorithms (Respiratory Motion Inc.) to obtain these measurements.     The study hypotheses are that the non-invasive, impedance-based RVM monitor will accurately     reflect TV, RR and MV in obese surgical patients before induction of general anesthesia,     during controlled ventilation and following extubation; that ExSpiron will accurately reflect     the post-extubation respiratory status of the patient; and that apnea and hypopnea episodes     in the recovery room as detected by the ExSpiron monitor are correlated with the individual     risk for obstructive sleep apnea as determined by the STOP-Bang risk stratification.   "
111592|NCT01825265|"     Primary:        -  To assess the safety and tolerability and to find the maximum tolerated dose of the          combination administration of RAD001 plus docetaxel when given to patients with          metastatic breast cancer who are being considered for standard docetaxel treatment          (phase I).        -  To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase          I).      Secondary:        -  To assess the clinical efficacy of the combination regimens in this patient population          as shown by response (according to the modified RECIST criteria) (phase II).        -  To determine the phosphorylation status of the components of the mTOR signaling pathway          and the expression of modifiers of apoptosis in the primary breast tumors, in order to          determine whether these markers can be used as predictors of sensitivity to the          combination of RAD001 and docetaxel        -  To determine the effect of the combination of RAD001 and docetaxel on the expression and          phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify          potential pharmacodynamics markers of response to this drug combination   "
111619|NCT01824914|"     Difficult tracheal intubation is a cause of severe patient damage and death. There is not a     good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization     of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a     Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of     the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to     compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the     role of videolaryngoscope in predicting difficult intubation.   "
111593|NCT01825252|"     During the formative research phase, investigators will undertake formative studies to     locate, understand, and characterize high-risk social networks of African American MSM in the     community; gain community participation, involvement, and input; and undertake interviews     with key informants and community members to gain information needed to pilot test study     recruitment procedures, measures, and intervention content.      During a 4-year main outcome trial phase, the investigators will enroll 24 separate     sociocentric (bounded) social networks composed predominantly of Black MSM. Each     sociocentric network will consist of the ring of friends surrounding an initial high-risk     index as well as all friends surrounding persons in this second ring and then friends     surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network     is expected to consist of approximately 40 unique members (n=24 networks, each with 40     members = approximately 960 individual participants).      All participants will be assessed at baseline to measure sexual practices, substance use, and     other risk characteristics over the past 3 months; asked to provide biological specimens to     be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD     risk reduction. STDs will be treated and those with HIV will be referred for treatment.      The investigators will identify the individuals in intervention condition networks with the     greatest number of reciprocal interconnections and the most favorable sociometric standing in     the network. These individuals--expected to constitute approximately 20% of the sociocentric     network and designated as network leaders--will be recruited to attend a 9-session program     that provides training and guidance in how to deliver on-going, theoretically-based, and     culturally tailored risk reduction advice and counseling to other members within the same     network.      Six and 18 months following the intervention, all participants will be reassessed on risk     behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with     positive STD and HIV cases respectively treated or referred to care at each assessment point.     Outcome analyses will test whether there is greater reduction in high-risk sexual practices,     substance use associated with risky sex, and HIV/STD incidence within social networks in the     intervention condition. The primary trial endpoints are reductions in prevalence and     frequency of unprotected anal intercourse with nonexclusive partners, increased condom use,     and lower incidence on a composite biological measure of new HIV/STD disease during the     followup period.   "
111594|NCT01825239|"     Presently, the left ventricular lead is placed in a similar position for all patients. It is     not known whether placing this lead in different positions in the heart will make the heart     pump better. In this study, the investigator will collect measurements of the heart's     electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that     these measurements will provide the know how to develop an individualized left ventricular     lead placement prescription for patients referred for left ventricular lead pacing.   "
111595|NCT01825226|"     Helen Keller International (HKI) has been implementing homestead food production (HFP)     programs in Asia for the past 20 years and has recently begun implementing HFP programs in     Africa as well. In general, these programs target women and are designed to improve maternal     and child health and nutrition outcomes through three primary pathways: 1. Increasing the     availability of micronutrient-rich foods through increased household production of these     foods; 2. Raising income through the sale of surplus production; and 3. Increasing knowledge     and adoption of optimal nutrition practices, including the consumption of micronutrient-rich     foods. Evaluations of HFP programs have consistently demonstrated significant increases in     household production and consumption of micronutrient-rich foods. This increased consumption,     along with improvements in health and nutrition related knowledge, and increased income,     could all contribute to improvements in maternal and child health and nutrition outcomes.     However, to date there has been limited understanding as to how these types of programs can     be optimized to maximize impacts on these outcomes.      In order to better understand the potential of these types of programs to improve maternal     and child health and nutrition outcomes and how this impact may be achieved IFPRI has been     collaborating with HKI to evaluate one of their E-HFP programs in Burkina Faso. The     evaluation considers impact of the program through the three pathways above, and assesses     anthropometric and clinical measures of nutrition, as well as looking at how the programs     might be improved.   "
111596|NCT01825213|"     The purpose of this study is to evaluate the feasibility to stratify liver fibrosis in     patients with chronic liver disease through non-invasive, spectral CT.   "
111597|NCT01825200|"     The hypothesis for this trial is that the incidence of a pre-defined composite of common     systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that     reported for licensed IIV recipients. Another hypothesis is that the safety and     reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety     profiles previously observed with Flublok and with the licensed comparator.   "
111598|NCT01825187|"     The purpose of this research study is to measure the clinical effectiveness of two different     polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of     hospital stay, perioperative complications, recurrence rate, pain score, comfort level and     postoperative quality of life. A secondary goal of the study is to evaluate the ease of use     and time it takes surgical residents to place the mesh and perform the surgery using these     two different meshes.   "
111599|NCT01825174|"     The purpose was to investigate the consequences of pediatric overweight on the     musculoskeletal system, postural control and proprioception, and to analyze prospectively the     influence of ball games and nutrition counseling.   "
111600|NCT01825161|"     The main purpose of this study is to utilize a comprehensive, prospective clinical database     to collect patient, diagnostic and treatment variables along with disease specific and     generic health related quality of life (HRQOL) data on consecutively treated patients with     metastatic spine tumors. The objectives are to determine the validity and reliability of the     Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes,     to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool     for predicting the stability of spine in metastatic spine disease, and to determine the     efficacy of surgery versus radiotherapy for the treatment of impending instability secondary     to metastatic disease of the spine.   "
111601|NCT01825148|"     The purpose of the study is to determine whether there are differences in pancreatic uptake     of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D     patients have a markedly reduced uptake, the compound may be suitable for estimation of     pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.   "
111602|NCT01825135|"     The primary aim of this proposal is to test the effectiveness of NMES in improving functional     status and muscle function in patients requirng prolonged mechanical ventilation   "
111603|NCT01825122|"     To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking     cessation in patients with chronic cough associated with long-term smoking, with or without     airflow obstruction, including those with established chronic obstructive pulmonary disease     (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared to     placebo and standard of care, while undergoing a validated smoking cessation program.   "
112288|NCT01816178|"     It was proposed that in order to teach these children to use a Voice Output Communication Aid     (VOCA), it should be introduced through a play-based situation using parents as the primary     interventionist.   "
111604|NCT01825109|"     Rotavirus is the leading cause of severe gastroenteritis in infants and young children     worldwide and is estimated to account for 600,000 deaths in children <5 years of age.     However, live oral enteric vaccines (e.g. OPV, cholera vaccines, typhoid vaccine) have been     less immunogenic in poor communities with high levels of malnutrition and poor sanitation.     Rotavirus vaccines also appear to be less immunogenic in the setting where they are most     needed. High maternal antibody (IgG) to rotavirus and breast feeding near the time of     vaccination may inhibit rotavirus vaccine effectiveness. We propose a quick study to look at     practical ways to improve the immunogenicity of rotavirus vaccine in our own setting in     Bangladesh. The objectives are to assess if delaying Rotarix vaccination will improve the     immune response to the vaccine and to assess if avoiding breastfeeding in the 45 minutes     before and after vaccine administration will improve the immune response to administration of     Rotarix vaccine. The study will be conducted in the urban Dhaka Mirpur Community, a setting     where previous rotavirus vaccine immunogenicity studies have been successfully conducted. A     total of 300 infant will be randomly assigned to one of the following groups: 1)     Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine     with no intervention in normal breastfeeding practices before and after receiving vaccine. 2)     Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.     Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes     after each vaccine administration. 3) Administration of Rotarix at 14 and 18 weeks     co-administered with oral polio virus, with no intervention in normal breastfeeding practices     before and after receiving vaccine. 4) Administration of Rotarix at 14 and 18 weeks     co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior     to vaccine administration and 45 minutes after each vaccine administration. Blood and stool     samples will be collected from infants and breast milk from mothers. The primary outcome is     to determine the sero-conversion rate of anti-rotavirus IgA in different groups of infants.   "
111605|NCT01825096|"     The principal advantages of functional magnetic resonance imaging (fMRI) with     blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are:     non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the     ability to map function over the entire brain. Thus, BOLD fMRI is the most widely applied     technology to study healthy brain function and pathophysiology associated with disease. In     studies of drug abuse and psychiatric illness though, normal assumptions mapping BOLD signals     to neurometabolism may be violated. Generally, these effects are ignored, resulting in large     study-to-study variability.      Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of     drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral     metabolism during brain activation during visual stimulation measured with a new fMRI     approach that is simple enough for clinical applications will be compared to CMRO2 activation     measured using standard qfMRI.   "
111606|NCT01825083|"     Procedures performed under sedation have the same severity in regards to morbidity and     mortality as procedures performed under general anesthesia1. The demand for anesthesia care     outside the operating room has increased tremendously and it poses, according to a closed     claim analysis, major risks to patients. Both closed claim analysis identified respiratory     depression due to over sedation as the main risk to patients undergoing procedures under     sedation. The major problem is that hypoventilation is only detected at very late stages in     patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation,     hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.      The incidence of anesthetized patients with obstructive sleep apnea has increased     substantially over the last years along with the current national obesity epidemic. These     patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The     context of the massive increase in procedural sedation and the extremely high prevalence of     obstructive sleep apnea poses major respiratory risks to patients and it may, in a near     future, increase malpractice claims to anesthesiologists. The development of safer anesthesia     regimen for sedation are, therefore, needed. The establishment of safer anesthetics regimen     for sedation is in direct relationship with the anesthesia patient safety foundation     priorities. It addresses peri-anesthetic safety problems for healthy patient's. It can also     be broadly applicable and easily implemented into daily clinical care. Ketamine has an     established effect on analgesia but the effects of ketamine on ventilation have not been     clearly defined. The investigators have demonstrated that the transcutaneous carbon dioxide     monitor is accurate in detecting hypoventilation in patients undergoing deep sedation. Animal     data suggest that when added to propofol in a sedation regimen, ketamine decreased     hypoventilation when compared to propofol alone. It is unknown if ketamine added to a     commonly used sedative agent (propofol) and fentanyl can decrease the incidence and severity     of hypoventilation in patients undergoing deep sedation.      The investigators hypothesize that patients receiving ketamine, propofol and fentanyl will     develop less intraoperative hypoventilation than patients receiving propofol and fentanyl.      The investigators also hypothesize that this effect will be even greater in patients with     obstructive sleep apnea than patients without obstructive sleep apnea.      Significance: Respiratory depression due to over sedation was identified twice as the major     factor responsible for claims related to anesthesia. The high prevalence of obstructive sleep     apnea combined with more complex procedures done in outpatient settings can increase physical     risks to patients and liability cases to anesthesiologists. The main goal of this project is     to establish the effect of ketamine in preventing respiratory depression to patients     undergoing procedures under deep sedation using propofol and fentanyl.      If the investigators can confirm our hypothesis, our findings can be valuable not only to     anesthesiologist but also to other specialties (emergency medicine, gastroenterologists,     cardiologists, radiologists) that frequently performed procedural sedation.      The research questions is; does the addition of ketamine prevent hypoventilation during deep     sedation using propofol and fentanyl?      The hypotheses of this study: Ketamine will prevent hypoventilation during deep sedation     cases.   "
111607|NCT01825070|"     Cherries have been show to possess the ability to reduce uric acid concentrations and     inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds     than other cherries and hence makes the expectation possible that Montmorency cherries will     lower uric acid and inflammation.   "
111608|NCT01825057|"     General medical hospitals provide care for a disproportionate share of patients who abuse or     are dependent upon substances. This group is among the most costly to treat and has the     poorest medical and substance use outcomes. Motivational interviewing(MI) is a     well-recognized, evidenced-based substance abuse treatment that has been adapted for use as a     brief intervention in health care settings.MI is applicable to many health-related behavioral     problems, and can be taught to a broad range of health care clinicians. However, it is     unclear which implementation strategies will lead to the efficient and proficient uptake of     MI in general medical settings, such as medical inpatient units.      Primary care clinicians have multiple practice demands and time constraints. New practices     have the greatest chance of being implemented if they are simple and compatible with existing     workflows and systems. Two widely used strategies to bring specialized practices into use     within general hospital settings are the see one, do one apprenticeship model of training     and use of consultation-liaison (CL) services. See one, do one has been a modus operandi in     medical education for centuries and relies upon a competency-based supervision training     approach. While it has been empirically validated in the specialty addiction field, less     controlled testing of this implementation strategy is available in general medical settings.     The apprenticeship approach requires that appropriate patients and trainers are available     with high flexibility for teaching and supervision; when applied to behavioral counseling     approaches, this may be seen as incompatible with the medical role and time constraints of     clinicians. In contrast, ordering MI through CL is a relatively simple, minimally burdensome     process and highly compatible with the way clinicians secure other specialist services for     their patients in the hospital.      We propose to conduct a randomized controlled trial using mixed quantitative and qualitative     methods to examine the effectiveness of three different strategies for integrating MI into     the practice of healthcare providers working within Yale New Haven Hospital's internal     medicine hospitalist service and other general medical inpatient units. Specifically, we will     randomize 40 healthcare providers to one of three conditions: (1) a continuing medical     education workshop that provides background and shows healthcare providers how to conduct     MI (the control condition, called SEE ONE); (2) a see one, do one apprenticeship model     involving workshop training plus live supervision of bedside practice (DO ONE); and (3)     ordering MI from CL after learning about it in a workshop (ORDER ONE). Following the     respective MI trainings, each healthcare provider will be assessed for the provision of MI to     40 study-eligible inpatients, recruited by the research team after admission to our general     medical units.   "
111620|NCT01824901|"     This randomized phase I/II trial studies the side effects and best dose of fibroblast growth     factor receptor (FGFR) inhibitor AZD4547 when given with docetaxel and to see how well it     works in treating patients with recurrent non-small cell lung cancer. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. FGFR inhibitor AZD4547 may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is     not yet known whether docetaxel and FGFR inhibitor AZD4547 are more effective when given     together or separately.   "
111621|NCT01824888|"     JUC is a commercially available wound care spray. It is evaluated for the efficacy when using     as a hygienic hand rub following the protocol described in the European standard EN 1500:1997     Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirement     (phase 2/step 2). A crossover study to compare the JUC solution with 60% (v/v) propan-2-ol     by using Escherichia coli K12 NCTC strain 10538 as test organism.   "
111609|NCT01825044|"     This is an open label study on the pharmacokinetics and safety of ciclosporin in patients     with severe traumatic brain injury, who require intensive care unit admission and monitoring     of intracranial pressure via a ventricular catheter. 20 patients will be screened, and     subsequently enrolled after clinical stabilisation. Thereafter, patients will receive 2.5     mg/kg bolus dose infusion of ciclosporin, followed by either 5 mg/kg/day or 10 mg/kg/day of     ciclosporin as continuous infusion for 5 days+3 days monitoring at the intensive care unit.     After an additional 30 days, a follow-up phone call will be made to the patient, or the     patient's nursing staff, checking patient status and serious adverse events. The two dose     levels will be investigated in 10 patients each, starting with the lower dose level for the     first 10 patients. Patients will have samples of blood and cerebrospinal fluid drawn at     pre-defined time points during the study for pharmacokinetic assessment and evaluation of     biomarkers. Bedside monitoring with microdialysis and brain tissue oxygenation will be     performed. The safety monitoring includes nephrotoxicity, hepatotoxicity, monitoring of     intracranial pressure (ICP), infections monitoring and adverse events collection and     reporting.   "
111610|NCT01825031|"     A randomised controlled trial to investigate three methods to reduce early mortality in     adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART)     with severe immuno-deficiency. The three methods are:      (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral     drugs from 3 classes      (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12     weeks      (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.   "
111611|NCT01825018|"     Formative Research Phase (Months 1-6) The investigators will undertake qualitative formative     studies to: (1) identify barriers to highly active antiretroviral therapy (HAART) and     strategies currently used to engage PLH in care; (2) identify access points and ways to reach     a diversity of PLH social networks; (3) gain an understanding of PLH views, motivations,     barriers, and facilitators of care entry, maintenance, and adherence; (4) examine the     structure and segments of the PLH community in St. Petersburg; and (5) elicit input from     members of the PLH community and its stakeholders concerning the planned network recruitment,     assessment, and intervention procedures and content. The investigators will refine protocols     used in their intervention pilot study based on findings of the formative research phase.      Main Trial Phase (Months 7-60)      Overview of the main intervention outcome trial's experimental design. The main trial is a     two-arm randomized outcome study. A total of 32 sociocentric social networks of PLH will be     recruited by first identifying initial seeds—always PLH who are either out-of-care or     treatment nonadherent—in multiple access points that were identified in the formative phase.     The investigators will then enroll three rings of HIV+ friends outward beginning with each     seed. Each sociocentric network is expected to consist of approximately 16 to 18 individuals     (expected n=32x18=576 participants). This estimate is based on the size and density of     participants' personal networks observed in our pilot studies. Each network member will be     assessed at baseline using measures to be described shortly and will receive individual     motivational counseling in care and adherence. This session will prime participants to an     understanding about the availability, accessibility, and benefits of care. Members of the 16     PLH networks randomized to the experimental condition will then receive the network     intervention. Cadres of empirically identified influence leaders within each network will be     identified, trained, and engaged to reinforce network member engagement and adherence. At 6-     and 12-month followup points, assessment data will again be collected to determine     intervention impact on the primary and secondary outcomes.   "
111612|NCT01825005|"     The main aim is to validate and improve the predictive model for survival and toxicity in     patients with cervical cancer through multicentric prospective data collection. The data     contain information on patient, tumor and treatment characteristics. For this study,     additional health related QOL scores will be assessed using the EORTC Quality of Life     Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a     Decision Support System based on the predictive model validated in this study.   "
111613|NCT01824992|"     to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for     the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type     infections and clinical negative conversion.      285 patients with positive high risk HPV infection were randomized into interferon gel group     and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control     group). The patients in treatment group received 1g recombinant human α-2b interferon gel     every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in     control group.   "
111614|NCT01824979|"     The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other     commercially available masks for continuous positive airwary pressure (CPAP) therapy.   "
111615|NCT01824966|"     There has been much controversy surrounding the biologic behavior and prognosis of esophageal     signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the     investigators compared the clinicopathologic features and prognosis of SRCs with other     adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).   "
111616|NCT01824953|"     Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic     gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination     of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for     detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis.     The investigators aimed to uncover whether this combination method could predict the risk of     gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the     participants will be followed for an expected average of 3 years.   "
111617|NCT01824940|"     Globally, stunting affects 26% (165 million) of under-5-year children, underlies 15-17% of     their mortality and leads to long-term cognitive deficits, fewer years and poorer performance     in school, lower adult economic productivity, and a higher risk that their own children will     also be stunted, perpetuating the problem into future generations. Stunting begins     antenatally and peaks at 18-24 months of postnatal life, when mean length-for-age Z-score     (LAZ) is about -2.0 among children living in Africa and Asia. Improving the diets of young     children can reduce stunting, though, at best, only by about one-third. Frequent diarrheal     illness has also been implicated. However, the effect of diarrhea on permanent stunting is     relatively small, maybe because children grow at catch-up rates between illness episodes.      The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by a 2-part     premise:        -  A major cause of child stunting and anemia is Environmental Enteric Dysfunction (EED).          EED is a subclinical disorder of the small intestine, which is virtually ubiquitous          among asymptomatic people living in low-income settings throughout the world. EED is          characterized by increased permeability which facilitates microbial translocation into          the systemic circulation and triggers chronic immune activation.        -  The primary cause of EED is infant ingestion of fecal microbes due to living in          conditions of poor quality and quantity of water, sanitation, and hygiene (WASH).   "
111623|NCT01824862|"     Clinically significant macular edema (CSME) is a thickening of the macula associated with the     risk of visual loss, which increases its centre is involved. Functional evaluation of the     macula relies on best corrected visual acuity; however, neural dysfunction in diabetic eyes     appears before retinal thickening and visual loss. Retinal sensitivity decreases in eyes with     CSME, but it is unknown whether it differs between eyes with and without centre thickening.      Aim: To compare the reduction of foveal sensitivity in eyes with CSME, with and without     centre thickening.   "
111624|NCT01824849|"     Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss     than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective     evidence for such conclusion is lacking. There is no study comparing swallowing and voice     after total and partial arytenoidectomy.   "
111625|NCT01824836|"     E1Z11 is a study to determine whether certain genetic information can predict which breast     cancer patients will discontinue treatment with AIs due to the development of musculoskeletal     symptoms (MSS). Women with stage 1-111 breast cancer who are prescribed the aromatase     inhibitor anastrozole as treatment may join.   "
111626|NCT01824823|"     This randomized phase II trial studies how well giving afatinib after chemoradiation and     surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and     neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth.   "
111627|NCT01824810|"     This pilot study is being conducted to provide proof of concept for three recently developed     needling treatments, in the treatment of whiplash associated disorder type 2 (WAD-II). The     investigators aim to show that these techniques should be considered as regular, effective     options for people suffering from WAD-II. These techniques are Intramuscular stimulation     (IMS), neural prolotherapy (NPT), and myoActivation (mA).      Additionally, the investigators plan to begin profiling responders and non-responders in an     effort to identify which treatment is likely to work best for different people. In the     future, this may help to expedite treatment for WAD-II, helping patients get the most     appropriate treatment, more quickly.      The investigators expect to show that all three treatments are significantly better than a     placebo treatment, and to collect information on what makes each technique more or less     likely to work for individual cases.   "
111628|NCT01824797|"     The purpose and objective of this study is to determine the changes in bone metabolism after     bariatric surgery in postmenopausal women.      This is a prospective cohort study that will enroll up to 40 postmenopausal female subjects     with class II and III obesity from the Duke Center for Metabolic and Weight Loss Surgery. The     study team will enroll subjects that are already being scheduled for either sleeve     gastrectomy or Roux-en-Y gastric bypass. The osteoclast activity, the osteoblast activity,     and the bone mineral density will be measured in all subjects preoperatively and 12 months     postoperatively through research specific blood tests and Dual energy x-ray Absorptiometry     (DEXA) scans.      The primary endpoints are change in osteoclast activity as measured by C-terminal telopeptide     of type I collagen and change in bone density as measured by DEXA scan. These are continuous     variable and given the small sample size the investigators will use a nonparametric Wilcoxon     rank-sum test to compare the difference in one year change in these variables. There is a     slight risk of loss of confidentiality. Every effort will be made to protect all PHI. There     is also the risk of increased exposure to radiation from the DEXA scans performed twice with     each subjects participating in the study.   "
111629|NCT01823809|"     The purpose of the study is to assess the diagnostic accuracy of a combined use of     non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress     cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and     with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to     invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.   "
111630|NCT01823796|"     Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with     generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms:     fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders.     The prevalence has been reported to be between 2 and 5%.      The hypothesis of this study is that women with fibromyalgia present high risk of falls and     balance disorders compared with healthy women. The objective of this study was to investigate     wether gait pattern changes in single and dual task conditions were associated with the risk     of falling in women with fibromyalgia.   "
111631|NCT01823783|"     Duchenne muscular dystrophy (DMD) is the most common and devastating form of muscular     dystrophy, caused by an X-chromosome gene mutation resulting in the absence of the protein     dystrophin. Gene therapy by exon skipping or stop codon read-through and cell therapy are at     the stage of clinical assays with very promising results. Nevertheless, they will not allow a     complete cure of DMD patients and they will concern only specific types of mutations. It is     therefore crucial to develop other therapeutic strategies related to the natural history of     the disease and targeted not on the dystrophin itself, but on the consequences of its     absence.      Another crucial pathophysiological pathway in DMD is muscle cell calcium homeostasis,     particularly via the ryanodine recepteur (RyR1).      Our study focus on the relationship between endomysial fibrosis, abnormal inflammation     response and calcium homeostasis dysfunction which are not entirely established in DMD.      The identification of the biological mechanisms that play a role in the severity of the     phenotype, particularly endomysial fibrosis, should allow the development of targeted     pharmacotherapy as a complementary strategy for the future treatment of DMD.   "
111665|NCT01824576|"     The purpose of the study is to evaluate the physiological response to application of the     Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.     The study will evaluate the physiological response to intrathoracic pressure regulation (IPR)     therapy in hemodynamically stable patients with compromised cerebral circulation who are on     ventilatory support.   "
111807|NCT01822470|"     The purpose of this study is to investigate the prevalence of small intestinal bacterial     overgrowth (SIBO) in patients who will be undergoing an enteroscopy as an outpatient     procedure with symptoms of functional dyspepsia. In addition, the investigators would like to     identify the types of bacteria that are present in the small intestines in patients with SIBO     and compare two different diagnostic tools: microbiologic culture and DNA sequencing of     bacteria.      The aim is to compare the microbiota between patients with and without the clinical     complications of SIBO   "
111632|NCT01823770|"     Several studies report association between restless legs syndrome (RLS), HTA and     cardiovascular diseases .      The mechanisms involved in this relationship remained unknown, but several evidences favor     the role of periodic limb movements in sleep (PLMS), patterns frequently associated with RLS.     Sympathetic overactivity is associated with PLMS with increased pulse rate and blood pressure     coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations could     contribute to the risk of high blood pressure, heart disease, and stroke in patients with     RLS, especially in the elderly. Several studies already reported that dopaminergic agonists     reduce the severity of RLS and the PLMS index.      Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic     dysfunctions in patients with RLS? Nocturnal BP (blood pressure) decline has major clinical     implications, and the loss of normal reduction in BP during sleep is associated with high     risk of cardiovascular morbidity and mortality.      The main aim of this study was to evaluate the impact of rotigotine patch treatment on     validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio,     and endothelial function in patients with idiopathic RLS compared to placebo.   "
111633|NCT01823757|"     This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100     patients will be selected into this controlled study.The hypothesis are:        1. After patients receive pharmaceutical care, their drug related problems will be          decreased.        2. After patients received pharmaceutical care, their self-reported medical expenditure          will be decreased.   "
111634|NCT01823744|"     The purpose of this trial is to better define how individuals with different genetic make-ups     will require different interventions to improve their methylation potential and nutrient     status.   "
111635|NCT01823731|"     objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description     of perioperative tumor burden and surgical approaches in the management of ovarian cancer,     tubal cancer, and primary peritoneal cancer   "
111636|NCT01823718|"     Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow     transplantation, organ transplantation or patient immunodeficient.      They will receive one to three injections of allogenic CTL specific EBV.      The purpose of this study is to ensure that these injections can not cause a GVH and to study     what the side effects are and to see whether this therapy might help patients with Lymphoma.      Immunological monitoring will also be studied.   "
111637|NCT01823705|"     The purpose of this feasibility study is to provide safety data on the implantable Exilis     gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to     levels that are comfortable for implanted subjects during chronic daily treatment, and to     collect data on acute gastrointestinal function and food intake responses to GES during     in-clinic testing.   "
111638|NCT01823692|"     The purpose of this study is to evaluate whether ultrasonography guidance compare with the     simple radiography aids in determining the adequacy of distal radius fracture reduction.   "
111639|NCT01823679|"     Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell     carcinoma of the skin.   "
111640|NCT01823666|"     Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The     investigators assume that some psychological and imaging risks may predict the conversion. In     the current longitudinal study, psychological and imaging data of people with MCI will be     obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be     found in comparison with controls.   "
111641|NCT01823653|"     The purpose of this study is to assess the safety and efficacy of treatment with the     Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue     (SAT) of the thighs.   "
111642|NCT01823640|"     Our primary objective is to set up the Human Rhinovirus (HRV)-model in our centre. In     addition, to facilitate future clinical trials, we want to determine optimal read-out     parameters and read-out time points for experimental HRV infection in healthy volunteers.     Furthermore, we want to analyze to what extent HRV can cause systemic immune effects, and we     want to test if subjects with antibodies against HRV can be re-infected with the same virus,     and if the presence of HRV antibodies influences the local clinical and immunological     response upon infection. Additionally, to gain insight in the immune modulating properties of     HRV, we want to investigate the immunological response to a HRV re-infection within one week     to determine if there are mechanisms that provide immediate protection against re-infection.     This facilitates a cross-over design of future pharmacological intervention-trials.     Furthermore, we want to investigate the capacity of HRV infection to modulate the systemic     immune response by analyzing the response of leukocytes ex vivo stimulated with different     stimuli. Moreover, we want to evaluate the effects of HRV-16 infection on the host     transcriptome and metabolome. Finally, The influence of HRV-16 infection on nasal and gut     microbiota will be assessed.   "
111643|NCT01823627|"     Purpose: Patients with mental health disorders have a reduced life expectancy, compared to     the general population. The shorter life expectancy is caused by natural and unnatural death.     In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the     general population, characterized by e.g. lack of exercise and smoking.      Hypothesis      Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients     There is a higher prevalence of COPD in psychiatric inpatients compared to the general     population Screening of patients with one respiratory symptom and a smoking history, has the     same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking     history      Method:      80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment     Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will     be taken into account.   "
111663|NCT01824602|"     The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine     acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with     placebo, as therapy in patients with acute mania. The secondary objectives of this study were     to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093)     administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration     to onset of action in the different dose groups, and c) monitor the appearance of depressive     symptoms.   "
120157|NCT01713153|"     This is a large, community-based, cluster-randomized trial to compare routine prophylactic     use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly     during the third stage of labor   "
111644|NCT01823614|"     To date, all work related to the study of HIV tropism, was performed on HIV B and C subtypes.     In the studied samples, HIV variants of subtype A were virtually absent. However, the     existence has been shown previously of some differences in the nucleotide sequences in the V3     loop of env region of subtype A from other subtypes of virus. In the Russian Federation the     subtype A of HIV-1 is predominant, and, according to some estimates, accounts for about 89%     of all newly diagnosed cases of HIV infection. Thus, it seems interesting and effective to     study the characteristics of HIV-1 subtype A, associated with the tropism, in the Russian     Federation.      The primary objective is determination of the prevalence of R5 (chemokine receptor 5), X4     (chemokine receptor 4), and R5X4-tropic variants of HIV in HIV-infected population in Russia,     and analysis of the possible features of tropism of viruses belonging to subtype A.   "
111645|NCT01823601|"     The aim of present study is to evaluate whether a program of behavioral and cognitive     procedures for emotional control, and assertive training, produces well-being and improvement     in quality of life of healthy volunteers.   "
111646|NCT01823588|"     A number of strategies have been evaluated to improve the prevention and control of the main     cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized     lifestyle educational programs were found to improve blood pressure (BP) control and     adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy     of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among     hypertensive adults.      Participants will receive usual care and a guideline-based educational program on BP control     and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email     alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder     program on the compliance with a healthy lifestyle based upon current guidelines for CVD     prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment;     randomization will be made centrally and blood samples will be evaluated into a single,     accredited laboratory.   "
111647|NCT01823575|"     Malignant ureteral obstruction often necessitates chronic urinary diversion and is associated     with high rates of failure with traditional double-J ureteral stents. To overcome drawbacks     of the double-J stent, recently, metallic stents have been used to manage for palliative     treatment in patients with ureteral obstruction associated with end stage malignant disease.     The success rates of metallic stents have been reported to be high and the method proved to     be useful in patients with malignant ureteral obstruction. In addition, covered metallic     stents have many advantages compared with bare metallic stents, such as lower rate of tissue     invasion and higher patency rate. However, there is little investigation about comparison of     clinical efficacy between covered-metallic stents and double-J stents in malignant ureteral     obstruction.      Therefore, investigators plan to perform a prospective randomized study to compare clinical     efficacy of silicone-covered metallic ureteral stent and double-J ureteral stent in patients     with malignant ureteral obstruction.   "
111648|NCT01823562|"     This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in     black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us     design future chemoprevention studies and assist in making future dietary recommendations for     men at high risk for prostate cancer.   "
111649|NCT01824784|"     To determine optimal cut-off value for TopQ cut-off.   "
111650|NCT01824771|"     Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively and     replace renal function partly. It is widely used in intensive care units (ICUs), especially     for patients with acute kidney injury/failure in an unstable hemodynamic status. Lactate is a     molecule smaller than glucose, which can pass through filtration membrane freely in CVVH.     Therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status     in patients with unstable hemodynamic status. However, there is no prospective study     evaluated the effect of CVVH on lactate removal in critically ill patients. The influence of     different dose of CVVH on lactate elimination is not clear in patients with different level     of serum lactate. Our study aimed to find out how the dose of CVVH effects on lactate     clearance, and then re-estimate the prognostic value of lactate in critically ill patients     with CVVH.   "
111651|NCT01824758|"     90 American society of anesthesiology (ASA) physical status I and II patients undergoing     general anesthesia for elective surgery will be included in the study. Patients will be     randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (1.5     mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After     intravenous induction with propofol, adequate muscle relaxation for intubation will be     received by 0.5 mg/kg rocuronium.   "
111652|NCT01824745|"     This randomized pilot clinical trial studies survivorship care planning in improving the     quality of life in breast cancer survivors. Survivorship care planning may reduce stress and     improve the well-being and quality of life of cancer survivors.   "
111653|NCT01824732|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in December 2012.      The purpose of this study is to make a event monitoring to see whether Tanreqing injection is     safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection     in hospitals in China.   "
111654|NCT01824719|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in January 2013.      The purpose of this study is to make a event monitoring to see whether Reduning injection is     safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in     hospitals in China.   "
111655|NCT01824706|"     A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of     Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™      The patients will be included as soon as they are ilplanted and follow-up for 2 years. It is     observationnal so no specific exam is planned.      The explantation rate will be measured, that is to say the number of patients whose     prosthesis will be removed (with or without any relationship with the implant or the     procedure).   "
111664|NCT01824589|"     The purpose of this study is to demonstrate proof of clinical concept that application of the     Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion     Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head     injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).   "
111656|NCT01824693|"     This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and     melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant     works in treating younger patients with juvenile myelomonocytic leukemia. Giving chemotherapy     before a donor hematopoietic transplant helps stop the growth of cancer cells. It may also     stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem     cells from a donor are infused into the patient, they may help the patient's bone marrow make     stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether     giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before     a donor stem cell transplant is more effective in treating juvenile myelomonocytic leukemia.   "
111657|NCT01824680|"     The primary purpose of this protocol is to assess the hormonal regulation of satiety by an     intense exercise before and after a 3 month physical activity program. Hormones assessed are:     leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.      It is well known that in overweight adults and children also, an intense physical exercise     diminish the food intake relatively to the total energy expenditure and this effect is     persistent after a 6 weeks physical activity program.      Our hypothesis are: a diminution of food intake after the intense physical exercise and a     persistent diminution of food intake after the 3 month physical activity program, an     augmentation of levels of GLP-1 and PYY during the intense exercise before and after the     physical activity program, a diminution of the level of GLP-1 and leptin before and after the     physical activity program   "
111658|NCT01824667|"     The aim of the study is to evaluate the effects of a new food supplement which is currently     available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g.     bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms     but are otherwise healthy.      About 400 volunteers will take part in this study, which will last 6 weeks (to include 4     weeks treatment and 2 weeks follow up period).      Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and     flatulence), in the absence of diseases, are commonly associated with food or drug intake or     with alterations of bowel habit and vary between individuals in frequency and severity.      Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously in     trials with healthy younger and older adults and we have observed a trend towards reducing     abdominal bloating. However, the investigators have not tested B-GOS in healthy adults who     often experience these symptoms and this is what we will investigate now.   "
111659|NCT01824654|"     An increasing incidence of abdominal aortic aneurysms (AAA) is observed in our ageing     population. Since it is less invasive, endovascular repair (EVAR) by stent-graft (SG)     insertion is frequently indicated in patients with intermediate and high-operative risk.     Patient selection and stent planning for EVAR is done on CT-scans based on specific anatomic     criteria. SG are inserted in the catheterization laboratory under digital substraction     angiography (DSA) and fluoroscopic guidance. With this technology, no soft-tissue     differentiation is available during the intervention and important information are lacking     such as thrombus and aneurysm extension close to proximal and distal landing zones. Our team     has recently patented a software allowing the extraction of the AAA (lumen and thrombus) from     pre-operative CT-scanner. In collaboration with Siemens medical, the investigators have     integrated this technology to the Siemens workstation in the catheterization laboratory. The     investigators can now import the aortic lumen and thrombus meshes segmented from     pre-operative CT-scans and perform a rigid registration with fluoroscopy and DSA data to     enhance visualization of soft tissue during EVAR.      Our preliminary results are encouraging in terms of feasibility and visualization. However,     the delivery device of the SG and the guidewire used during the intervention are stiff and     induce a deformation of aortic lumen and thrombus. This deformation impairs the accuracy of     rigid registration. The investigators propose to improve registration accuracy by     implementing an elastic deformation of aortic lumen and wall based on the segmentation of     endovascular devices (delivery device, guidewires and catheters) inserted during the     procedure and by biomechanical modeling.   "
111660|NCT01824641|"     The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial     Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a     planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction     (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration     using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to     conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index     of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus     aspiration compared to conventional PCI group.   "
111661|NCT01824628|"     This is a unicentric, two cohorts, observational transversal study.      The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects     receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.   "
111662|NCT01824615|"     Patients with early and advanced stages of epithelial ovarian cancer are treated with     postoperative systemic chemotherapy after appropriate surgical staging and cytoreductive     surgery. For ovarian cancer patients with recurrence, salvage chemotherapy with or without     secondary cytoreductive surgery are recommended. The recommendation for specific primary     adjuvant or salvage chemotherapy is cyclophosphamide or paclitaxel plus platinum regimens.     Despite the high objective response rate associated with primary chemotherapy in ovarian     cancer, the majority of patients will eventually experience disease recurrence and be     potential candidates for a second-line treatment approach.      Ovarian clear cell adenocarcinoma (OCCA) is recognized as a distinct histological type of     cancer in the WHO-classification of ovarian tumors. OCCA is thought to arise from     endometriosis and most patients present with the disease at early stages (International     Federation of Gynecology and Obstetrics (FIGO) stages I and II). The incidence of OCCA among     epithelial ovarian cancers is estimated to be less than 5-10%. However, OCCA occurs more     frequent in Japan and Taiwan (around 10-15%). Unfortunately, OCCA is usually more resistant     to systemic chemotherapy than other types and has a poorer prognosis.      Sunitinib is a small molecule with anti-tumor properties pharmacologically mediated through     inhibition of multiple receptor tyrosine kinase (RTKs), which are important regulators of     tumor cell growth, angiogenesis, and metastasis. Due to its multi-targeted profile, the     pharmacological activity of sunitinib is likely mediated by inhibition of multiple RTK     targets and multiple pathways. c-KIT has been implicated in mastocytosis/mast cell leukemia,     germ cell cancers, small-cell lung cancer, GISTs, AML, neuroblastoma, melanoma, and ovarian     and breast carcinoma. In addition, sunitinib has demonstrated a higher response rate than     that reported for anti- VEGF antibody treatment in patients with renal cell carcinoma (RCC).     A few clinical case reports indicated sunitinib is effective in treating recurrent ovarian     clear cell adenocarcinoma (OCCA) which is almost resistant to second line chemotherapy.      So we would like to conduct this Phase II Sunitinib clinical trial in recurrent / persistent     ovarian clear cell cancer patients.   "
118006|NCT01741337|"     The aim of this clinical trial is to evaluate the effect of an early treatment of     sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following     coronary artery bypass graft surgery or other coronary reperfusion.   "
111666|NCT01824563|"     The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala     electrode. As a point of interest the investigators would like to evaluate the benefit to     patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode.     The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a     variety of contemporary surgical techniques that have been shown to enable easy insertion and     to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and     Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus     Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to     cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus     Mid-Scala has already shown to be a safe electrode and promising post op clinical results in     the premarketing study that is now in the final stage.   "
111667|NCT01824550|"     The objective of this study is to determine the effect of home-based, aerobic exercise     training on subclinical atherosclerosis and mobility disability in persons with Multiple     Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both     subclinical atherosclerosis and mobility disability.   "
111668|NCT01824537|"     Human papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is     capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina,     and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have     been proven to be highly effective in preventing the acquisition of HPV infection and the     genital precancerous lesions caused by it. However, we do not know yet if a previously     infected individual, once vaccinated, would be less infective to her or his sexual partner.     We plan to conduct a study, called Transmission Reduction And Prevention with HPV vaccination     (TRAP-HPV) study to answer this question. It will include 500 sexually active couples (total     of 1000 individuals) in university student health clinics in Montreal (age 18-45 years). It     will be a randomized placebo-controlled, double-blinded intervention trial. Study     participants will be followed up to 12 months. Behavioural and biological data will be     collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment.     The results of this trial will be invaluable in informing policies regarding vaccination of     women and men.   "
111669|NCT01824524|"     The purpose of this study is to assess the single dose pharmacokinetic profile (explores what     a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone in     chinese participants with cancer (abnormal tissue that grows and spreads in the body) who are     not opioid (morphine-like medications) tolerant (decrease in response to a fixed dosage of     drug over time and higher doses of a drug are needed to get desired effect).   "
111670|NCT01824511|"     The most widely-accepted animal model of nicotine withdrawal states stopping nicotine makes     rewarding events become less rewarding. The current study will test if this is true in     humans. If we find tobacco abstinence does make rewards less rewarding, this would suggest     new symptoms to add to official descriptions of nicotine withdrawal. It would also suggest we     need to develop new behavioral and pharmacological interventions to correct this problem. If     stopping smoking does not make rewards less rewarding, this would suggest this animal model     does not apply to the human condition and we need to continue to search for an animal model     of tobacco withdrawal that is relevant to smokers stopping smoking.   "
111671|NCT01824498|"     The primary objective of this investigation is to determine whether diets designed to     increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment),     will favorably affect sex hormone distribution in women in a direction associated with     reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an     increased concentration of circulating n3 fatty acids will reduce the biochemical markers     associated with increased risk for developing certain sex hormone mediated cancers such as     breast cancer   "
111672|NCT01824485|"     Viscosupplementation by intra-articular injection of hyaluronate products has recently gained     popularity as a treatment modality of gonarthritis.There is not, however, a consensus on the     best method.Our objective is to evaluate what is the best dosage of viscosupplementation with     hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of triamcinolone hexacetonide. One     hundred and four patients with knee osteoarthritis (KOA) were divides into 2 groups of 52     patients each to receive either a single application of 3 ampoules of OSTEONIL® + 1ml of     Hexacetonide of triamcinolone or three applications of 1 ampoule of OSTEONIL®, one per week     for three weeks + 1ml of Hexacetonide of triamcinolone only in the first injection. Primary     endpoint was clinical results expressed by Visual Analogic Scale of pain (VAS), Western     Ontario and Mcmaster Universities (WOMAC) and Lequesne questionaires at one, three, six and     12 months after the procedure   "
111673|NCT01824472|"     Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some,     but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The     purpose of this study is to find out what type of insomnia symptoms are caused by obstructive     sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with     continuous positive airway pressure (also known as CPAP) and if additional treatment with     cognitive-behavioral therapy for insomnia is beneficial.   "
111674|NCT01824459|"     The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin     vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Diffuse Gastric Adenocarcinoma     or Gastroesophageal Junction Adenocarcinoma Patients.   "
111675|NCT01824446|"     To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the     study drug. Further, the study will determine how much of the study drug gets into the     bloodstream and how long it takes the body to get rid of it when given as a single dose to     healthy male subjects.   "
111690|NCT01824251|"     Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed     based on the European Federation of Neurological Societies/ Peripheral. Nerve Society     Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion     criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive     days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory     Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse     events by one year after the start of the study treatment.   "
111678|NCT01824407|"     The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as     the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of     diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act     on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE®     device has not been approved for the treatment of diabetic foot ulcers; therefore its use in     this study is investigational.      The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic     foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to     an inactive look-alike device (called a Sham) in this study. The sham device will not     provide any treatment to your diabetic foot ulcer.   "
111679|NCT01824394|"     To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with     THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory     symptomatic paroxysmal atrial fibrillation (PAF).   "
111680|NCT01824381|"     The purpose of this study is to analyze the security application of the amniotic membrane in     extensive wounds in the granulation phase.   "
111681|NCT01824368|"     The purpose of this study is to evaluate the safety of extracorporeal photopheresis in     patients with long-standing liver transplantation subjected to a progressive reduction of     immunosuppression by complications arising from its use.   "
111682|NCT01824355|"     The purpose of this study was to demonstrate that untrained subjects who have diabetes can     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose     results.   "
111683|NCT01824342|"     This is a multi-national, multi-center, open-label, single-arm extension study for the     prolongation of bone metastasis-free survival in men with hormone-refractory (androgen     independent) prostate cancer. Patients currently participating in the phase 3 study 20050147     (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is     determined in the 20050147 study. The primary endpoint of the 20050147 study is bone     metastases-free survival determined by the time to first occurrence of bone metastases     (either symptomatic or asymptomatic) or death from any cause. Participants will receive     open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they     developed a bone metastasis or for up to 3 years, whichever comes first.   "
111684|NCT01824329|"     Bladder cancer is the 4th most common cancer amongst men. If bladder cancer invades the     muscle of the bladder or fails local treatments, surgical removal of the bladder (cystectomy)     with creation of a new bladder from intestine is required. However, standard cystectomy     affects urinary function and sexual function. The investigators are evaluating two     modifications to cystectomy to determine to what extent they preserve urinary and sexual     function.   "
111685|NCT01824316|"     Investigate differences in practice patterns in providers who may care for pregnant women     with asthma exacerbations. The investigators believe that practitioners of different     specialties will practice differently.   "
111686|NCT01824303|"     The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system,     is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in     IC symptoms following LiRIS administration.   "
111687|NCT01824290|"     The main purpose of this study is to evaluate the safety and efficacy of tadalafil in     pediatric participants with pulmonary arterial hypertension. Participants will receive study     treatment for 6 months in the double-blind period (Period 1), and then will be eligible to     enroll into an open-label 2 year extension period (Period 2) during which participants will     receive tadalafil.   "
111688|NCT01824277|"     The Canadian Diabetes Association recommends optimizing glycemic control to achieve a     glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these     recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of     suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients     experience a higher rate of post-operative complications and significantly worse short-term     and long-term post-operative survival. Therefore, it is recommended that attempts should be     made to improve glycemic control while patients wait for their elective surgery. However, at     present processes of care that facilitate pre-operative glycemic control optimization do not     exist in Canada.      The objective of this project is to determine the feasibility and effectiveness of a     comprehensive community-based pre-operative diabetes optimization program for patients     awaiting elective cardiac surgery.   "
111689|NCT01824264|"     The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of     LIK066 to support dose selection for phase 3.   "
111691|NCT01824238|"     This study will evaluate the effects of anacetrapib (MK-0859) on low-density     lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with     heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying     therapy.   "
111692|NCT01824225|"     Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial     monthly intravitreal aflibercept for the Japanese age related macular degeneration.   "
111693|NCT01824212|"     Recognition of out of hospital cardiac arrest (OHCA) during an emergency call is based on     standardized questions concerning the symptoms of OHCA. With this method cardiac arrest is     recognized in 50-83% of cases. When the emergency medical dispatcher identifies cardiac     arrest during the emergency call the survival of the patient improves. Accurate emergency     medical service response is activated promptly and bystander will receive cardiopulmonary     resuscitation (CPR) instructions. It has been estimated that proper implementation of CPR     instructions will save thousands of lives each year.      If the ECG could be recorded by the mobile phone, transmitted during the emergency call to     the dispatch centre and analysed there with the software of a semi-automated external     defibrillator(AED), the recognition of cardiac arrest could be more accurate.      The aim of this study is to examine, if AED, with minimal size electrodes within an area of a     mobile phone, is able to recognize reliably ventricular fibrillation (VF), the rhythm with     the best prognosis in OHCA.   "
111694|NCT01824199|"     If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid     secretion in patients taking once a day omeprazole.   "
111695|NCT01824186|"     This study aims to evaluate post-operative pain in single-incision laparoscopic     cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators     hypothesize that SILC is non-inferior in post-operative pain.   "
111696|NCT01824173|"     Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle,     a condition that can impair muscle metabolism. The proposed research will discover mechanisms     responsible for decreased content in mitochondrial proteins as well as in protein     β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese     individuals. This research will further examine the effectiveness of interventions, such as     increased plasma amino acid availability and exercise, to increase the rate of production of     mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The     findings will help to develop appropriate interventions to improve muscle ATP turnover and     metabolism in obese people.   "
111697|NCT01824160|"     The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in     the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the     right ventricle of the heart to the pulmonary arteries. Patients undergoing replacement of     their pulmonary valve by transcatheter technique Melody Valve) are at risk of developing such     tears in the process of preparing the conduit to accept the new valve. In order to implant     such a valve, the connection between the right ventricle and the pulmonary arteries often     needs to be enlarged. High pressure balloons may be needed and these balloons can sometimes     cause tears in or even rupture of the connecting conduit. Such tears can allow blood to flow     into the chest and rarely this can lead to a life-threatening emergency. Experience suggests     that such tears can be closed by implanting into the conduit a metallic stent with an outer     covering, rebuilding the wall and allowing continuation of the valve implant.   "
111698|NCT01824147|"     It is the aim of the present study to assess the prevalence of ASS-Nonresponse following     cardiac surgery using the Multiple Electrode Aggregometry (MEA).   "
111699|NCT01824134|"     The investigators are testing two over the counter aloe veras on irradiated breast tissue.   "
111700|NCT01824121|"     There is evidence suggesting that stem cells harvested from the bone marrow and transplanted     into the brain may be effective in slowing down the progression of parkinsonism. Mesenchymal     stem cells are able to produce growth factors that provide support to diseased nervous cells.      In this study mesenchymal stem cells will be harvested from the bone marrow, cultivated in a     test tube so that they multiply and then infused into the arteries that supply blood to the     brain in 20 patients suffering from a rare form of parkinsonism, Progressive Supranuclear     Palsy. Each patient will undergo two infusions, one with the stem cells and one without, at     an interval of 6 months. The sequence of the two infusions will be assigned randomly;     patients and assessors will not know the sequence (double-blind). Patients will be     followed-up for up to 1 year after the last infusion, with regular assessments to assess     safety, efficacy on motor and cognitive functions, and effects on the brain by neuroimaging     techniques.      The study has a preliminary phase with 5 patients all given stem cell therapy alone, designed     to assess safety   "
111701|NCT01824108|"     Lumbar disc herniation is usually treated by discectomy alone. Nonfusion system such as     Wallis interspinous implants have also been successfully used in disc degenerative diseases.     However, the superiority of a discectomy with Wallis in comparison to a discectomy alone for     primary lumbar disc herniation has yet to be determined.The aim of our study is to     investigate whether lumbar discectomy combined with the Wallis device provides better     radiographic and clinical short-term outcome than posterior lumbar discectomy alone.   "
111702|NCT01824095|"     The purpose of this multisite randomized controlled trial (RCT) is to compare the short-term     (6 week) and long-term (6 month) effect of chiropractic care combined with a specific     nutritional supplement regimen to chiropractic care with a placebo supplement for patients     with ankle sprains, in terms of improvement in physical function and pain.   "
111703|NCT01824082|"     When a limb is traumatically severed, pain perceived in the part of the body that no longer     exists often develops. This is called phantom limb pain, and is different from stump     pain, which is pain within the part of the limb that remains intact. Unfortunately, phantom     pain resolves in only 16% of people, with the rest experiencing this pain for the remainder     of the lives. There is currently no reliable treatment for phantom limb pain.      The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut—as happens     with a traumatic amputation—changes occur in the brain and spinal cord that actually worsen     with increasing phantom pain. These abnormal changes may often be corrected by putting local     anesthetic—termed a peripheral nerve block—on the injured nerve, keeping any bad signals     from reaching the brain, with resolution of the phantom limb pain. However, when the nerve     block ends after a few hours, the phantom pain returns. But, this demonstrates that the brain     abnormalities—and phantom pain—that occur with an amputation may be dependent upon the bad     signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve     block—lasting many days rather than hours—may permanently reverse the abnormal changes in the     brain, and provide lasting relief from phantom pain.      Until recently, extending a peripheral nerve block beyond 16 hours was unrealistic. However,     a treatment option called a continuous peripheral nerve block is now available. This     technique involves the placement of a tiny tube—smaller than a piece of spaghetti—through the     skin and next to the nerves supplying the amputated limb. The tiny tube may be placed with     minimal discomfort in about 15 minutes. Numbing medicine called local anesthetic is then     infused through the tube, blocking any signals that the injured nerve sends to the spinal     cord and brain. Using a small, portable infusion pump, this prolonged nerve block may be     provided in individuals' own homes.      The ultimate objective of the proposed research study is to determine if a 6-day continuous     peripheral nerve block provided at home is an effective treatment for persistent phantom limb     pain following a traumatic limb amputation. The primary hypothesis (what the researchers     predict) is that phantom limb pain intensity will be significantly decreased 4 weeks     following treatment with a 6-day continuous peripheral nerve block.   "
111704|NCT01824069|"     It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells     derived from lipoaspirate for treating various pathologies fistula. With this project we will     address a study population with critical ischemia of lower limbs without possibility of     revascularization, either by technical criteria (no intervention possible to compensate for     the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for     the type of intervention required). It will almost always elderly patients with multiple     comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with     very high probability of major amputation in the short term or immediate.      Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded ex vivo, are capable     of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable     a safe manner   "
111705|NCT01824056|"     The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET     to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders,     including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive     supranuclear palsy (PSP).   "
111826|NCT01822223|"     The purpose of this study is to determine which implant-abutment design is more likely to     promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant     bone and soft-tissue health.   "
111706|NCT01824043|"     Primary Objective:      To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis     (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy.      The primary endpoint for the study will be the mean change in best-corrected visual acuity     (BCVA) from baseline to the mean level at Month 3.      Secondary Objectives:        1. To assess any differences in mean change in BCVA over time;        2. To assess differences in vitreous transparency (amount of hemorrhage) with fundus          angiography exam;        3. To assess any differences in retinopathy severity level according to the Early Treatment          Diabetic Retinopathy Study;        4. To correlate the visual outcomes with serum glucose levels.   "
111707|NCT01824030|"     Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL)     is a major clinical issue. Intravascular techniques (assessing either the anatomy or the     functional effect of coronary stenoses) are routinely used to better characterize coronary     lesions. Among these,fractional flow reserve (FFR) provides validated functional insights     while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both     techniques may be applied to guide decisions regarding the opportunity to revascularize     patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We     aim to compare the clinical and the economical impact of FFR versus OCT guidance in the     percutaneous management of patients with AICL.   "
111708|NCT01824017|"     The current proposal extends work done in mouse models evaluating the consistency of     measuring RLIP76 in a clinical cohort (Aim 1) by using guidelines provided by the NIH for     validating biomarkers. We will also proceed to estimate the effect size of a potential     correlation of RLIP76 with standard MsY treatment measures such as hgbA1c, LDL, and     triglyceride levels in a longitudinal prospective study ( Aim 2) that will follow a cohort of     patients with MsY who seek care at the City of Hope Endocrine clinic over a 12 month period..   "
111709|NCT01824004|"     This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant     treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.   "
111710|NCT01823991|"     The purpose of this study is to examine the safety and influence of an intervention     (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on     cognitive performance in breast cancer survivors following chemotherapy. The investigators'     goal is to treat or lessen the late effects of cancer treatment. The supplement to be used     will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins     from blueberries (BB) and (2) n-3 fatty acids - Lovaza.   "
111711|NCT01823978|"     This is a Phase I, non-randomized, dose escalation study of the safety, biomarkers, and     preliminary efficacy of dendritic cell vaccine, BPX-201, plus activating agent, AP1903, in     patients with metastatic castrate resistant prostate cancer.   "
111712|NCT01823965|"     In the prospective monocentric open label trial patients with diabetic macular edema will be     treated with intravitreal injections of ranibizumab given for 3 months then with laser grid     at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case     of best-corrected visual acuity decreased more than 5 letters.   "
111713|NCT01823952|"     A randomized, double-blind trial in adult males with acute dehydrating diarrhea of cholera     comparing the safety, tolerability and efficacy of HAMS HO-ORS, HAMS 2.5% Acetate HO-ORS,     HAMS 6% Acetate HO-ORS and HO-ORS.      The primary hypothesis is that at least one of the hypo-osmolar ORS containing high amylose     maize starch 6% acetate (HAMSA6-HO-ORS), hypo-osmolar ORS containing high amylose maize     starch 2.5% acetate (HAMSA2.5-HO-ORS) and a hypo-osmolar ORS containing high amylose maize     starch (HAMS-HO-ORS), will significantly reduce diarrhea duration compared with hypo-osmolar     (HO) ORS.      Specifically, the investigators expect that HAMSA6 will be the most effective preparation.   "
111714|NCT01823939|"     This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are     grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients.     This is not a hypothesis-driven research study.   "
111715|NCT01823926|"     Introduction: Inhalation therapy has been established as an efficient route to treat asthma     exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.      Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and     radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using     vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation     (NIV).      Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in a     crossover study. Patients was randomly assigned to participate in both phases of the study:     Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used to     inhaler using JN positioned in the circuit using a T piece, particle size generation in a     five micron range and oxygen flow tritated at eight L/min and MN was positioned in the mask,     particle size generation in a one range and connected to electrical energy. NIV was used a     bilevel pressure through a face mask attached with straps and pressure adjusted were 12 cmH2O     and 5 cmH2O as inspiratory and expiratory pressures, respectively. After, radioactivity     counts were performed using a gama camera and regions of interest were delimited. To     calculate aerosol mass balance the investigators considered the amount of radioaerosol     deposited into the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and     expiratory filters, and mask divided for each of these compartments and represented as a     percentage.   "
111719|NCT01823874|"     Clinical benefits of VR analgesia have been empirically demonstrated as either an alternative     or in combination with opioids. Issues of cost, ergonomics, and maintenance of the hardware     systems have limited the wider use of this benefit to the public. Firsthand Technology has     designed a system to meet the performance requirements for high levels of pain control in a     durable, ergonomic package at a greatly reduced cost compared to the current systems in use.     This study will validate the new system by running a thermal pain study that tests the effect     of the new system (ID) compared to the established standard helmet currently used.   "
111720|NCT01823861|"     An individual randomised controlled trial (RCT) to evaluate the effectiveness of a     voice-based mobile phone health (mHealth) intervention to support post-abortion family     planning (PAFP) at four Marie Stopes International clinics in Cambodia.      The study seeks to address the research question: does a PAFP mHealth intervention increase     use of contraception in Cambodia?   "
111890|NCT01821378|"     The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in     subjects with an acute exacerbation of schizophrenia.   "
111721|NCT01823848|"     Functional constipation is extremely common in children and is defined as painful, hard     stools or firm stools for twice or less per week. Functional constipation accounts for 3% of     general pediatric visits and up to 25% of pediatric gastroenterology visits. Constipation and     fecal impaction can lead to a range of symptoms including decreased appetite, vomiting, and     abdominal pain frequently resulting in Emergency Department (ED) presentation. In contrast to     the outpatient setting where diet and oral medications work well to relieve symptoms related     to functional constipation, ED management requires an approach with quicker results. For     immediate relief of symptoms, disimpaction via enema use may be better than polyethylene     glycol (PEG) 3350 for children. However, the type of enema to be used is not well studied.     Currently, any patient presenting to the ED with a presumed diagnosis of abdominal pain due     to functional constipation receives an oral dose of PEG and one of the following three types     of enemas (based on the ED treating attending's discretion): phosphate or Fleets enema,     normal saline enema, or mineral oil enema. There is no evidence in the literature that     demonstrates any difference in the effectiveness of each of these enemas. The investigators     propose a randomized control trial of the three types of pediatric enemas readily used in our     ED to determine the best approach. There will be three arms within this study: a) PEG plus     phosphate enema b) PEG plus normal saline enema and c) PEG plus mineral oil enema. The     physicians enrolling patients will not be the treating physicians. The four principal     investigators (blinded to the type of enema being used), following appropriate informed     consent, will obtain pain scores (Faces Pain Scale - Revised) pre- and post-administration of     each of the three treatments listed above in order to determine the best enema to use in     children 4-12 years of age. Other outcomes to be analyzed will include the patient's weight     pre- and post-administration of the enema, satisfaction ratings on a visual analog scale from     the treating physician (who will also be blinded), and parental surveys on the day of     administration and 3-5 days following discharge. Data analysis for pain scores will be     completed with repeated measures anova. Categorical values will be compared using Chi Square     analysis and continuous variables will be compared using parametric statistics.   "
111722|NCT01823835|"     This study is a multi-institution, Phase Ia/Ib/IIa open-label, dose-finding, safety,     pharmacokinetics (PK), and proof-of-concept study of GDC-0810 as a single agent and in     combination with palbociclib and/or LHRH agonist. The study is divided into 3 phases: Phase     Ia, Phase Ib, and Phase IIa. During Phase Ia (dose escalation phase), GDC-0810 single agent     will be administered orally on a continuous daily dosing regimen with a Day -7 lead-in period     for single dose PK evaluation prior to the start of daily treatment. The incidence of     dose-limiting toxicities (DLTs) will be evaluated from Day -7 through the first cycle (28     days) of treatment (35 days total). Depending on safety and tolerability, participants will     be assigned sequentially to escalating doses of GDC-0810 using standard 3 + 3 design. During     Phase Ib (dose escalation and expansion phase), participants will receive GDC-0810 with     palbociclib and/or LHRH agonist to determine the recommended Phase II dose (RP2D) and assess     the safety and tolerability of concomitant administration. During Phase IIa (dose expansion     phase), participants previously treated with an aromatase inhibitor (AI) will be treated at     the RP2D to further characterize the safety, PK, pharmacodynamics, and anti-tumor activity of     GDC-0810.   "
111723|NCT01823822|"     This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to     investigate whether oral milk protein supplements led to increase in serum Insulin-like     Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric     supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested     product or control product for 4-week, followed by a 4-week follow-up.   "
111724|NCT01823549|"     This study was a survey to determine the frequency of Complementary and Alternative Medicine     (CAM) use in patients recently diagnosed with breast or prostate cancer who were starting     radiation therapy. The survey was repeated at three time points to assess changes in CAM use     over time.   "
111725|NCT01823536|"     In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody     persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10     years of age, and to evaluate response to a booster dose administered 5 years after primary     vaccination in the parent study V59P20 (NCT00616421).   "
111726|NCT01823523|"     Currently there is debate in the literature as to the recommended length of postoperative     antibiotics in patients undergoing orthognathic surgery. The investigators plan to     investigate using a randomized controlled trial the comparison between a 1 day and 3 day     regimen of antibiotics and the effects on post operative infection.   "
111727|NCT01823510|"     The purpose of this study is to determine whether treatment with ticagrelor + aspirin is more     effective than treatment with clopidogrel + aspirin in patients with type-2 diabetes. Both     treatments will be given (separately) to all subjects as a one-time loading dose (i.e. higher     than a normal daily dose), followed by daily dose for the next 5 to 7 days. Effectiveness of     treatment will be measured with specialized blood tests before the loading dose, at two     time-points after the loading dose, and once after the last daily dose.   "
111728|NCT01823497|"     The aim of this study is to examine the safety and effectiveness of 2 morphine delivery     systems for post-surgical neonates. The investigators hypothesize that this study will be     feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled     Analgesia pump will receive less morphine and experience fewer side effects than neonates     receiving morphine via continuous opioid infusion.   "
111729|NCT01823484|"     Compared with AN69 hemofilter, AN69 ST hemofilter may prolong the time of hemofilter and     decrease the quantity of heparin during continuous renal replacement therapy in critically     ill.   "
111759|NCT01823094|"     Investigators hope to learn more about how to use computed tomography (CT) scans to measure     blood flow in lung tumors and how it may change in response to treatment. This measurement     technique is called computed tomography perfusion (CTP). CT scanners use X-rays to produce     3-dimensional images of the body.      Currently, doctors determine the response to treatment by measuring the size of the tumor.     Investigators are trying to find out if measuring the blood flow in the tumor is equal to or     better than measuring the size of the tumor.   "
111763|NCT01823042|"     Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after     surgery treatment.So maintain remission medications were routinely given to patients after     surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium     glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken     medicine.There is a treatment blank period between surgery and onset time of maintain     remission medications.Enteral nutrition has been used in the induction remission and maintain     remission for CD.May be it can fill the treatment blank period.   "
111764|NCT01823029|"     Extra iron may not be necessary in the treatment of iron deficiency anemia in Crohn's     Disease;Oxidative Stress and Inflammation may be Caused by Intravenous Iron in Crohn's     Disease Patients With Iron Deficiency Anemia.   "
111904|NCT01821183|"     At this investigation we want to find out whether there is a difference in muscle strength of     the internal and external rotation hip muscles between soccer players and non-soccer players     caused by typical movement patterns seen in soccer sport.   "
111730|NCT01823471|"     Hereditary non-polyposis colon carcinoma (HNPCC or Lynch-Syndrome) is a rare cause of     colorectal cancer caused by a gene defect in the so -called mismatch repair genes. Patients     can present at young age with colorectal cancer and polyps can develop faster to malignant     lesions in comparison to classical sporadic adenomas. New advanced imaging modalities with     high definition images and virtual chromoendoscopy have a theoretical advantage to improve     detection and to increase polyp detection. In patients with HNPCC polyp detection has been     shown to be increased by classical chromo-endoscopy and by high definition endoscopy with     narrow band imaging (NBI) (a virtual chromo-endoscopy modality activated by a button on the     endoscope), in comparison to white light endoscopy. However, in these back-to-back studies     there was no randomization for the order of imaging modality. It is therefore not clear     whether really the image enhancement adds to increased polyp detection or if this is achieved     by a second inspection of the mucosa. In this trial the investigators want to assess the real     additional value of virtual chromo-endoscopy for polyp detection in patients with the Lynch     syndrome. The investigators will use the high definition pentax system and will compare white     light endoscopy to i-scan, the incorporated virtual chromo-endoscopy mode in this system.   "
111731|NCT01823458|"     Incentives are increasingly being used to motivate health behavior in medical studies. Small     cash payments conditional on certain health and welfare promoting behaviors have shown     efficacy in both real world and experimental settings. Furthermore, in incentive studies,     behavioral economics has been shown to amplify behavior change beyond what is possible with     simple cash payments, but little is known about how varying incentive payment design may     impact health behavior. The goal of the present study is to evaluate a new incentive payment     instrument, lottery insurance, to determine its impact on adherence to the target health     behavior, attendance at free exercise classes provided by QueensCare Family Clinics, a     safety-net medical clinic.   "
111732|NCT01823445|"     The purpose of this study is to demonstrate whether decay causing bacteria are reduced when     adhesive xylitol disks are used intraorally three times a day for two weeks in adults with     dry mouth.   "
111733|NCT01823432|"     Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but     very little is known about the genetic causes or risk factors for adverse outcomes.     Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years     old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the     ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to     use individual genetic information to identify persons with BAV who are at high risk for     complications and to customize therapies.   "
111734|NCT01823419|"     The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3 fatty     acids on executive functions. The investigators hypothesize that participants ages 7-9 years     with a ratio closer to 4:1 will do better on tests of executive function than participants     with a ratio closer to the purported Western diet norm of 15:1.   "
111735|NCT01823406|"     We will perform blood sugar studies to assess changes in metabolic (biochemical processes     that occur within us) profiles associated with high blood sugar and diabetes.   "
111736|NCT01823393|"     To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces     serious complications due to the procedure, by decreasing the rate of vascular and     hemorrhagic complications without increasing the rate of ischeamic events.   "
111737|NCT01823380|"     The main objective of this study is to investigate the correlation between the rate of motor     decline and blood levels of Vitamin D total. Secondary objectives are to investigate the     relationship between blood levels of vitamin D and total disease duration of ALS, forced     vital capacity, weight loss, age of onset and the start site of ALS.   "
111738|NCT01823367|"     This study is a randomized intervention that will test two different approaches reflecting     diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help     address a critical question in the translation of primary prevention research into the public     health: how much intensity (and thus cost) is required to achieve an effective outcome? In     addition, the proposed study will address a critical need in diabetes prevention that has not     received sufficient scholarly attention: the prevention of T2D in children. No studies of     diabetes prevention similar in scope to the DPP have been performed in school-aged children;     however, reducing childhood obesity is widely accepted as the primary pathway to decreasing     the growing prevalence of T2D in the pediatric population.   "
111739|NCT01823354|"     Restless leg syndrome (RLS) is a common neurological disorder whose diagnosis is only     clinical. The efficacy of dopaminergic agents in improvement of sensorimotor symptoms advance     the hypothesis that altered dopaminergic transmission is at the origin of this condition. RLS     usually leads to a sleep fragmentation, which induces sometimes severe insomnia most often     associated, in clinical practice, to a cognitive complaint (attentional in nature). Executive     functions in which dopaminergic transmission is heavily involved refer to a set of complex     functions. At least three of them should be considered during their evaluation (ie     flexibility, inhibition, and the updating of working memory). These functions are among the     targets of the alteration of the quality and quantity of sleep. The few studies that have     focused on the study of the integrity of executive functions in RLS have discordant results.     The lack of control of key variables in the assessment of executive functioning (ie     intellectual performance, depressive symptomatology, generalized slowing in information     processing) and the lack of reference in the theoretical approach in executive functions are     certainly the two main reasons. Moreover, the question of polysomnographic correlates and the     reversibility of these cognitive abnormalities after pharmacological management of RLS     remains unanswered today.      The main objective of this study is to compare the executive performance of untreated RLS     patients with a group of matched controls.   "
111760|NCT01823081|"     Eligible eyes are randomized to two groups. Group A will receive three intravitreal     injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of     combined bevacizumab and fasudil will be performed with the same frequency.      Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated     prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be     performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of     BCVA and CMT changes.   "
145785|NCT01376154|"     The purpose of this study is to confirm efficacy and safety when administering lamivudine     tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.   "
111740|NCT01823341|"     The purpose of this study is to see whether low blood sugar at night can be reduced by using     a system that turns off the insulin pump automatically. The study system includes a     continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular     laptop computer. A The system works by (1) measuring the glucose levels under the skin with     the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is     likely to occur, and (3) turning off the insulin pump when the computer program predicts that     a low blood sugar will occur.      We have tested the system in the home environment in individuals with type 1 diabetes age 15     years and older. We have found an indication that the system can decrease the frequency of     hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We     are now ready to further test the system in the home environment in a younger age group to     learn more about its ability to reduce overnight low blood sugar risk.      This study has several phases and will take about 3 months for a patient to complete.        -  First, the patient will use the CGM and pump at home for up to 15 days with the help of          a parent/guardian. This is done to determine if the patient meets our study criteria to          proceed with the next phase of the study.        -  If the patient is eligible to continue in the study, the patient will need to use the          full study system for at least 5 nights at home with the help of a parent/guardian. This          is done to make sure the patient and parent/guardian are able to use the system          correctly. The patient may participate in starting and stopping the system at home, but          the parent/guardian is responsible for making sure it is used as instructed.        -  After that, the patient will be asked to use the study system each night for an          additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the          system is used as instructed.      The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the     United States and Canada. First a study of children 8 to less than 15 years old will be done.     Then, a study of children 3 to less than 8 years old will be conducted.   "
111741|NCT01823328|"     The purpose of this study is to compare the effectiveness and safety of ketamine and     etomidate during rapid sequence intubation (RSI).   "
111742|NCT01823315|"     The investigators will conduct a trial to determine whether methotrexate single-dose     treatment and methotrexate/Actinomycin-D single-dose treatment work well as multiple courses     of single agent chemotherapy in low-risk gestational trophoblastic neoplasia.   "
111743|NCT01823302|"     The primary objective of the study was to compare the change in z-scores for growth during a     120-day study period in children with picky eating behaviors who were randomly assigned to     receive nutrition counseling only (control group) or nutrition counseling plus an oral     milk-based nutritional supplement (study group). The secondary objectives of the study were     to compare the following between the control and study groups: a) dietary macro- and     micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and     c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety     objective of the study was to compare the frequency of adverse events (AE) among the control     group and study group subjects.   "
111744|NCT01823289|"     The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential     therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal     infections ([IPFI]; lung diseases caused by fungal infection).   "
111745|NCT01823276|"     The objective of the proposed research is to determine if tyrosine, an amino acid found in     protein-containing foods, will mitigate the cognitive deficits and adverse effects on     behavior and mood produced by exposure to military stress. This study will be conducted at     the Army Survive, Evade, Resist, Escape (SERE) school at Fort Bragg, NC.      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain     neurotransmitter that is critical for the central nervous system (CNS) response to various     types of acute stress. Psychological stress increases catecholamine turnover in the brain,     increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and     human studies have shown that tyrosine supplementation can produce beneficial effects on     cognitive and physiological functions during exposure to a variety of acute stressors.      This project will determine if volunteers treated with supplemental tyrosine during stressful     phases of SERE training experience less degradation in cognitive performance and mood than     volunteers treated with placebo. Tyrosine or placebo will be administered in a specially     developed food bar provided to volunteers. The bar is part of a prototype of ration-component     designed for use during assault operations. A between-subjects, double blind experimental     design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has     been tested in hundreds of volunteers without adverse effects.      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 82     volunteers complete the study. They will be tested during several portions of SERE. A     comprehensive but brief battery of cognitive tests, as well as saliva and blood samples, will     be collected in a manner that does not interfere with ongoing training.      Hypotheses:        1. The adverse effects of psychological stress on cognitive performance and mood during          SERE school will be reduced when volunteers are given supplemental tyrosine compared to          placebo treatment.        2. Supplemental tyrosine will reduce release of proinflammatory cytokines that may be          increased by the stressful activities of SERE school.   "
111746|NCT01823263|"     The purpose of this study is to determine whether partial sleep deprivation, as compared with     normal sleep, influences certain metabolic and cognitive parameters, related to food intake,     hunger and memory functions, when participants are shielded from external time cues.   "
111747|NCT01823250|"     This Stage II randomized trial tests Culturally Informed & Flexible Family Based Treatment     for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and     yielding promising preliminary findings. Drug use rates are highest among Hispanic middle     school youth and to date no treatments have met criteria for Well Established in the     treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth     and families is complicated by the fact that these families often differ from mainstream     populations in culture-related values, beliefs and behaviors that can directly impact     engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop a     more powerful treatment capable of addressing these issues began with a Stage 1 study that     led to the development of a multi-component treatment that includes a flexible manual that     allows treatment tailoring to the unique characteristics of individual families. CIFFTA     integrates innovative culturally-based, individually-based, and family-based components to:     1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and     increase family protective factors (e.g., strong parent-child attachment), 2) teach     adolescents skills to effectively manage interpersonal conflicts and stressors and to     increase motivation to change, 3) deliver psycho-educational and culturally congruent     material (e.g., modules on immigration stressors) to youth and parents both separately and     together, and 4) deliver the intervention using a flexible treatment manual that allows the     clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational     modules and themes) to the unique characteristics and needs of the Hispanic family.      This Stage II randomized trial randomizes 220 Hispanic adolescents ages 14-17 who meet DSM-IV     criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional Family     Therapy. The study tests CIFFTA's efficacy in impacting drug use, risky sexual behavior, and     other severe behavior problems, and hypothesized mechanisms of change, in a larger and more     rigorous Stage II trial. Assessments occur at baseline, 4 months post baseline (end of     treatment), 10 months post baseline and 16 months post baseline. Should this line of research     continue to be successful, it has the potential to contribute to the field a highly     innovative and efficacious treatment for Hispanic drug abusing adolescents, a better     understanding of mechanisms of treatment efficacy, and also a framework for future flexible     and tailored treatments that can be used to better address the unique needs of other special     populations.   "
111761|NCT01823068|"     The purpose of this study is to investigate the efficacy and safety of vandetanib, in     patients with advanced non-small-cell lung cancer harboring RET gene rearrangement. In 2011,     gene rearrangement between RET and KIF5B gene (fusion) was discovered in a young, male lung     cancer patient. The following studies showed that this gene rearrangement was critical for     tumor initiation and maintenance. Of note, the growth and signaling properties mediated by     KIF5B-RET were diminished after treatment with vandetanib.      Until now, RET rearrangements have been known in thyroid cancers. Vandetanib, a multi-kinase     inhibitors with anti-RET activity, is an FDA-approved drug for the treatments of adults with     metastatic medullary thyroid cancers who are ineligible for surgery and who have progressive     or symptomatic disease. This study aimed to examine the efficacy and safety of this drug, for     the treatment of advanced lung cancer harboring RET rearrangement.   "
145838|NCT01375452|"     The purpose of this study is to compare bioavailability in healthy, post menopausal women     subjects under fasting conditions.   "
111748|NCT01823237|"     Dystonia is a disease where muscles in the affected body part are abnormally active. This may     result in abnormal postures. The underlying mechanisms are not known. One proposed mechanism     is located in the motor area of the brain that controls the coordination of muscles, called     the motor cortex. It is well known that the motor area of one hemisphere of the brain (motor     cortex) controls the movement of the opposite side of the body. When people perform tasks     such as picking up an object or writing there are mechanisms in motor cortex that focus the     level of activity so that they can do these tasks with a high level of precision. Focusing     activity in motor cortex seems to be disturbed in people with dystonia. Transcranial magnetic     stimulation (TMS) is a device that allows the non-invasive stimulation of the brain. When     applied to the motor cortex it can upregulate or down regulate its activity. In the present     study the investigators will conduct experiments on subjects with task specific focal hand     dystonia (such as writers cramp) using TMS to decrease unwanted motor activity. The     investigators will assess the effects of this intervention using objective, subjective and     kinematic measures. This is a pilot study and will require further research to assess the     long-term effects of repetitive TMS on task-specific focal hand dystonia.   "
111749|NCT01823224|"     The purpose of the study is to learn whether perioperative IV (intravenous) administration of     acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over     the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic     cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen,     it may result in fewer requests for pain-related intervention such as other oral pain     medications.   "
111750|NCT01823211|"     The purpose of this study is further risk stratification of patients receiving implantable     cardioverter-defibrillator in primary prevention of sudden cardiac death.   "
111751|NCT01823198|"     The goal of this clinical research study is to find the highest tolerable dose of immune     cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell     transplant to patients with AML and MDS. Researchers want to learn if adding NK cells will     help make the stem cell transplant more effective in treating the disease. The safety of this     treatment will also be studied.      NK cells may kill cancer cells that remain in your body after your last chemotherapy     treatment. The NK cells will be separated from blood from a relative of yours or from     umbilical cord blood. These separated NK cells will then be grown in the lab to increase the     number of NK cells that can be given to you by vein.      The chemotherapy given on this study will consist of the following drugs:        -  Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of          cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell          transplants.        -  Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the          cancer cells to die.        -  IL-2 (interleukin-2) is a naturally occurring protein (cytokine) that can enhance NK          cell function.   "
111752|NCT01823185|"     Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary     intervention (PCI) with stent implantation and during one year after PCI, to prevent     atherothrombotic complications. However, clopidogrel is ineffective in certain patients due     to genetic mutation in CYP2C19 gene a specific enzyme in the liver required for metabolism of     clopidogrel. Therefore, the purpose of this study is to test these patients genetically at     bedside and prescribe an alternative drug such as Ticagrelor (90 mg twice daily) or prasugrel     ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight <     60kg) if they are carriers of the allele 2 or 3 of the mutated gene.   "
111753|NCT01823172|"     The investigators plan to study the ability to identify the lymph nodes beyond the sentinel     lymph node that may harbor cancer using methylene blue dye.   "
111754|NCT01823159|"     The objective of this study is to characterize the effects of a single-dose of retigabine on     cortical excitability in healthy subjects, as quantified by means of TMS.   "
111755|NCT01823146|"     This study will investigate the extent to which intranasal oxytocin affects changes in social     decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the     body and the brain and has been shown to be relevant for many behaviors, particularly in     social situations. Research on the effects of oxytocin in aging is very scarce; therefore,     the purpose of this research project is to determine the effects of oxytocin on     socioemotional aging.   "
111756|NCT01823133|"     Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in     healthy subjects   "
111757|NCT01823120|"     Between 6% and 30% of people who harm themselves repeat this self-harm within the following     12 months. The investigators know that people who harm themselves are much more likely to     commit suicide, but the investigators have no clear evidence about the best way to reduce the     likelihood of someone harming themselves again.      Text messaging is now a common form of communication. Previous research has shown us that the     investigators can use text messages for different types of health care interventions.     Examples of this include reminding patients of medical appointments, delivering test results,     to check patient side effects following treatment and to reduce depressive symptoms in     patients with depression and alcohol problems. The Samaritans have introduced interactive     text messages (where you can have a conversation by text with their service) and have noted     an increasing use of this contact with their service.      This research study is taking place to find out if using supportive and interactive text     messages can reduce further episodes of self-harm in patients who present to the Emergency     Department (ED) with self-harm.      The investigators hypothesize that supportive, informative and interactive text messages     delivered to patients discharged from an ED after an episode of self-harm will significantly     reduce the frequency and intensity of thoughts of self-harm and self-harming behaviour in     patients compared with those receiving only follow-up treatment as usual. A secondary     hypothesis is that patients receiving the text messages will report a favourable experience     and an overall satisfaction with the system.   "
111758|NCT01823107|"     The purpose of the study is to evaluate the safety and feasibility of the use of Meso     BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during     2-stage, tissue expander assisted breast reconstruction.   "
111762|NCT01823055|"     To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic     organ prolapse in a prospective multicenter, single cohort study.   "
111767|NCT01822990|"     Circulating anti-beta2-glycoprotein antibodies have been associated with coronary artery     disease and peripheral arterial disease. This auto-antibodies could activate endothelial     cells leading to the expression of leukocyte adhesion molecules and increasing the release of     pro-inflammatory cytokines.      On the other hand, endothelial dysfunction of atherosclerotic patients acts as a primary     pathogenic event, as it occur before structural changes are evident on angiogram or     ultrasound scan. Loss of endothelial normal function causes vasoconstriction, local     coagulation alterations and an increase arterial wall proliferation. This situation s been     attributed to a reduction in nitric oxide bioactivity, and to an increase oxygen-free radical     formation in the context of the pro-inflammatory status found in atherosclerosis.      Hypothesis: Circulating Anti-beta2-glycoprotein I antibodies could be associated with     endothelial dysfunction and nitric oxide metabolism disruption en patients with peripheral     arterial disease.   "
111768|NCT01822977|"     The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is associated     with significant alterations in the healthy fecal microbiome that are similar to those seen     in persons with an initial episode of clostridium difficile infection (CDI).   "
111769|NCT01822964|"     The aim of this study is to assess the possible neuroprotective effects of cooling (targeted     cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI)     procedures. From start of anesthesia, until final valve implantation, local cooling (by the     RhinoChill device) will be applied to the brain. Effect of cooling on cerebral oxygenation,     by cerebral oxygen saturation monitoring (NIRS ForeSight technology) during the TAVI     procedure will be continuously assessed during native valve manipulation and during final     valve deployment (=primary endpoint of he study). As secondary endpoints, neuropsychological     testing performed before and after TAVI procedure will assess the effects of the use of     cooling during the TAVI procedure. Neuron-specific enolase (NSE) and S100-beta will be     analyzed during and up to 72hrs after TAVI to compare the cerebral ischemic damage between     cooled and non-cooled patients. And finally, diffusion-weighted MRI of the brain will be     performed 5 days before and 5-7 days after TAVI to compare the number and total amount of     cerebral ischemic insults between cooled and non-cooled patients. The hypothesis behind this     study is that by local cooling of the brain during manipulation of the calcified aorta and     aortic valve, the brain might be protected from cerebral ischemic insults.   "
111770|NCT01822951|"     The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared     to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT). In     addition, a traditional approach will be taken based on the evaluation of the separate risk     and benefit domains in comparison with donepezil.      Global risk-benefit as compared to donepezil will be analyzed by determining whether the     Cerebrolysin group shows a statistically significant non-inferiority with regard to the     combined primary safety and efficacy endpoints (weighted multivariate ensemble). The     endpoints will be combined by a global multivariate non-parametric procedure, weighting the     safety and efficacy part 50:50.   "
111771|NCT01822938|"     Physical exercise has been identified as a major item of many affecting many chronic diseases     and stroke rehabilitation. It contributes to an improvement in the quality of life and to a     decrease in the current treatment side-effects and mortality. Stroke in association with an     inactive lifestyle lead to a decrease in physical capability and causes problems in daily     activities. The physical capacity and the tolerance for exercise fall simultaneously leading     to vicious circle of less and less mobility. Therefore, physical activity for the health is a     valid and relevant way to improve the quality of life and to recover functional capacity. The     aim of the study is the assessment of the effects of a incentive program for physical     activity on people following/with stroke.   "
111772|NCT01822925|"     To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain     in subjects with diabetic neuropathic pain compared to their baseline values.   "
111773|NCT01822912|"     Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher     rehospitalization rates and mortality than patients discharged to home.      HF disease management programs have been shown to reduce rehospitalizations in community     settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF).      This study will investigate the the effect of a heart failure-disease management program on     the outcome of all-cause hospital readmissions, emergency room admissions and mortality for     30 days post-SNF admission using 7 component heart failure disease management program.   "
111849|NCT01821924|"     The investigators plan to use retrospective data to assess heart function and structure     abnormalities through the use of an approved vasodilating agent for stress cardiac MRI tests.     The investigators are interested in how these MRI findings relate to long-term prognosis in     people who are at risk for cardiac disease.   "
111774|NCT01822899|"     This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The     purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol     (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive     Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will     complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710     eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to     one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered     as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo     administered as one inhalation each morning and evening via single multidose powdered inhaler     (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and     evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A     safety Follow-up assessment will be conducted approximately 7 days after the end of the study     treatment (Early Withdrawal, if applicable). The total duration of subject participation will     be approximately 15 weeks.   "
111775|NCT01822886|"     Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate     efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin     (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL in a selected population of     patients.   "
112083|NCT01818843|"     Based on the study about carbon monoxide in human inflammatory and other beneficial     physiological function , now we'll be going to research its application in neonates .Phase 1     Study as a foundation for the further test is, the safety and Adverse reaction study of     newborn to inhaled CO   "
111776|NCT01822873|"     The study hypothesis is that patients with dry age-related macular degeneration experience     visual function impairments such as defects in dark adaptation, glare intolerance, poor light     transition and reading in low lighting conditions. Studies have shown that patients in the     early phases of AMD with normal visual acuity commonly reported difficulty with these visual     functions but there have been no systematic studies evaluating these deficits in this     population.      This prospective, exploratory study will include up to 130 patients with dry AMD and 60     controls. These patients will undergo the following non-invasive visual function testing:        -  microperimetry with eye tracking        -  low luminance visual acuity        -  specialized color vision (cone-specific)        -  contrast testing and night vision testing.      High-resolution spectral domain optical coherence tomography (SDOCT) images will be taken of     the central retina using the Spectralis OCT unit. The values of visual function tested will     be correlated with the findings on SDOCT (volume/amount of drusen present in early AMD).      There are no known risks to the subjects beyond what is normal for standard examinations of     the eye, visual function testing and standard ocular photographic procedures.   "
111777|NCT01822860|"     Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide     as measured by flow mediated vasodilatation.   "
111778|NCT01822847|"     Cortisol is essential for survival. The importance of cortisol response is most apparent in     patients with partial or complete deficiency of glucocorticoids during stressful events such     as illness or surgery.   "
111779|NCT01822834|"     The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis     (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple     clinical institutions.   "
111780|NCT01822821|"     Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid     consumption and/or pain intensity scores after cardiac surgery.   "
111781|NCT01822808|"     To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms,     cardiac parameters and functional status of African patients hospitalized with AHF and left     ventricular dysfunction during 24 weeks of therapy.      Administration of hydralazine/nitrates will be superior to placebo administration in reducing     HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic     peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.   "
111782|NCT01822795|"     -  BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited.          Lung volume reduction surgery is infrequently used because of its high morbi-mortality.          Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment          has been recently developed and has been shown to be feasible and associated with an          acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity          and lung function. The objective of this study is to analyze the cost effectiveness of          LVRC treatment in severe emphysema.        -  METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs          conventional treatment) will include 100 patients who will be followed up for 1year. The          primary outcome measure is the 6-month improvement of the 6-minute walk test: the          percentage of patients showing an improvement of at least 54m will be compared between          groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global          cost of this therapeutic option and will compare the cost between patients treated by          LVRC and by medical treatment alone.        -  EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in          severe emphysema. The cost-effectiveness study will assess the medical-economic impact          of the LVRC therapeutic option.   "
111783|NCT01822782|"     The main objective of this study is to assess whether the presence of abnormal vaginal flora     (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of     delivery. For this, the primary endpoint will be the proportion of vaginal lesions according     to the presence or absence of abnormal vaginal flora.      A more precise qualitative and quantitative study of vaginal flora isolated from pregnant     women and its association with vaginal lesions will also be conducted.   "
111784|NCT01822769|"     The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation     program improves aerobic exercise capacity and quality of life over the medium term for     patients with congenital heart disease with reduced exercise capacity. To test this     hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary     rehabilitation program or standard of care, with interval testing of aerobic capacity and     other physiologic markers improved fitness, as well as assessment of quality of life.   "
111850|NCT01821911|"     The objective of this study was to achieve the post-marketing safety and immunogenicity     research of Speeda® rabies vaccine for human use from Chengda Bio   "
111954|NCT01820520|"     Study designed to evaluate the safety and efficacy of double staining with brilliant blue G     0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or     epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography,     pattern reversal electroretinogram and multifocal electroretinogram.   "
111795|NCT01822626|"     Obesity is one of the leading causes of morbidity and mortality in the industrialised world.     Evidence is growing that early life nutrition can play a role in behavioural and cognitive     problems in children and adolescents and is well documented that being overweight and obese     during childhood can have short- and long-term physical and psycho-social health     implications.      This is an individually randomised trial to evaluate the efficacy of a family     pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged     4-7 years old. As secondary objectives the investigators evaluate the effect of the     counselling on dietary behaviours and physical activity.      The investigators targeted the intervention to overweight children, while obese children were     referred to specialised care. The counselling targeted diet, physical activity, and sedentary     behaviours.   "
111796|NCT01822613|"     To study the safety and efficacy of the combination of LJM716 and BYL719 against currently     available treatments of physician's choice in previously treated esophageal squamous cell     carcinoma patients.   "
111797|NCT01822600|"     To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration     of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.   "
111785|NCT01822756|"     This is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel     administered to patients with advanced or metastatic pancreatic cancer. The study will be     conducted in two parts.      Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of     ruxolitinib when given as described to patients with advanced or metastatic pancreatic     cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of     ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be     selected for use in Part 2 of the study.      Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary     clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with     gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic pancreatic     cancer.      After multiple challenges of trial conduct, by mutual agreement between investigators and     sponsor, dose escalation ended after Cohort B1, RUX 10 mg twice daily (BID) - GCSF in October     2014. Therefore, the MTD was not reached. No safety issues led to the decision to stop     further enrollment.      Because of the early study termination, samples for pharmacokinetics and pharmacodynamics,     and computed tomography for tumor burden were collected, but not analyzed; analysis data are     not available. The data cutoff for this posting is 22 SEP 2015. As of the data cutoff, 1     subject was receiving treatment in the study and had been enrolled for 47 weeks. This subject     had their end of treatment visit in AUG 2016. A comparison of this subjects' safety data     after the cutoff date showed no clinically meaningful differences (eg, adverse events)     compared with safety results that are summarized here.   "
111786|NCT01822743|"     The main objective is to evaluate an osteopathic compression of pterygopalatine node in     healthy subjects and patients suffering from obstructive apnea syndrome (OSA).   "
111787|NCT01822730|"     Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or     environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical     presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms),     response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic     neurotransmission) of both conditions. Both paliperidone and risperidone are second     generation antipsychotics，but have same pharmacological effects of antipsychotic treatment     and paliperidone may have more efficacy and safty.This study was designed to examine the     acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with     MAP.   "
111788|NCT01822717|"     The purpose of this study was to find out whether a method of nonvisual foot inspection,     using the senses of touch and smell, helps people with diabetes and visual impairment to find     new foot problems when they are in early, easily-treated stages. All people in the study had     regular foot inspections by podiatrists. The results include how people feel about the     method, whether they actually did check their feet it, and whether the method helped them to     discover foot problems themselves.   "
111789|NCT01822704|"     This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole     body vibration training program on physical functioning, societal participation and quality     of life in individuals with chronic stroke. It is hypothesized that the whole body vibration     program will induce significantly more gain in physical functioning, societal participation,     and quality of life in chronic stroke patients, compared with the control group.   "
111790|NCT01822691|"     The primary purpose of this research study is to assess whether the participant's disease,     Myelodysplastic Syndromes (MDS), responds favorably to INCB024360. The study will also     evaluate the long-term outcomes of the participant's disease after they have finished taking     INCB024360.   "
111791|NCT01822678|"     Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration     study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of     treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment     period; subsequently, down-titration (according to the dose steps and the time intervals of     up-titration) and administration of an established anti-manic therapy during the tapering-off     period (in patients who discontinued treatment) or entry into a recurrence prevention study     (Protocol PRA+SCO/BIA-2093-205; reported under separate cover) as an option for patients who     responded to the study treatment   "
111792|NCT01822665|"     This study evaluated the effect of oral fast-dissolving formulations of paracetamol and     ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic     examinations were conducted to determine the gastrointestinal damage produced post a 7 day     treatment regimen.   "
111793|NCT01822652|"     Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene     transfer research study.      We have found from previous research that we can put a new gene called a chimeric antigen     receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them.     In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost     all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to     patients that had neuroblastoma. The infusions were safe and in patients with disease at the     time of their infusion, the time to progression was longer if we could find GD2 T cells in     their blood for more than 6 weeks. Because of this, we think that if T cells are able to last     longer, they may have a better chance of killing neuroblastoma tumor cells.      Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to     live longer. These new genes are called CD28 and OX40. The purpose of this study will be to     determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to     patients with relapsed/refractory neuroblastoma.      In other clinical studies using T cells, some investigators found that giving chemotherapy     before the T cell infusion can improve the amount of time the T cells stay in the body and     therefore the effect the T cells can have. This is called lymphodepletion and we think that     it will allow the T cells we infuse to expand and stay longer in the body, and potentially     kill cancer cells more effectively.      The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and     fludarabine.      Additionally, to effectively kill the tumor cells, it is important that the T cells are able     to survive and expand in the tumor. Recent studies have shown that solid tumors release a     substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an     attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called     pembrolizumab.   "
111794|NCT01822639|"     The study is designed to estimate the bioavailability of amlodipine and enalapril maleate     fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril     maleate tablets. The rational for this study is to provide a more convenient dosing regimen     for patients. This is an open-label, randomized, single dose, two-way crossover study, in     which 16 healthy adult male and female subjects will be enrolled and dosed under fasting     conditions. Each subject will participate in two treatment periods of 7 days each. There will     be at least 14 days of wash out period between the two dosing periods and a follow-up period     of up to 21 days after treatment period 2. The total duration of study will be approximately     35 days from the start of the first treatment.   "
111798|NCT01822587|"     The investigators' recently completed study has provided the first evidence that     administration of the medication propranolol, following exposure to cocaine cues, can alter     drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine     addicted persons. The investigators will attempt to augment this effect by a) doubling the     number of propranolol-medicated cocaine cue exposure (CCE) retrieval sessions and b)     increasing the dose of propranolol. It is expected that propranolol treated groups, relative     to placebo treated groups, will evidence greater reduction of craving, cue reactivity and     cocaine use during follow-up cocaine cue exposures. Also, these effects will be greater for     those who receive 80mg of propranolol as opposed to 40mg.   "
111799|NCT01822574|"     This research was performed to determine which of the three techniques used by knee surgeons     at the Mayo Clinic was the most accurate at the surgical removal (resection) of the knee-cap     (patella) in a symmetric fashion during total knee replacement (arthroplasty). Although all     three techniques are known to be effective, the three techniques had never been compared to     one another to determine if one was more effective than the others at resecting the patella.   "
111800|NCT01822561|"     -  The goal of the study is to examine the short-term effects and safety of a systemic          anti-aldosterone medication, eplerenone, in a small group of patients with central          serous chorioretinopathy (CSCR).        -  There is currently no standard treatment or therapy for either acute or chronic CSCR, a          potentially debilitating eye disease.        -  There is evidence in both animals and humans that high blood serum corticosteroid levels          can cause or worsen CSCR or findings similar to CSCR in the choroid and retina        -  Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and          anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that          decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR        -  The investigators' aim is to evaluate a standardized dose of eplerenone in a controlled          prospective fashion for both acute and chronic CSCR.        -  The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1 month        -  Over the course of the month, patients will be monitored for side effects, as well as          visual and anatomical response to the medication   "
111801|NCT01822548|"     The purpose of this study is to evaluate the effect of Dipeptidyl peptidase (DPP) -IV     inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs)     number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12     months after randomization.   "
111802|NCT01822535|"     The ability to maintain normal body core temperature (Tcore = 98.6°F) is impaired in persons     with tetraplegia. Despite the known challenges to the ability of persons with spinal cord     injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in     able-bodied (AB) persons, there has been no work to date addressing these issues in persons     with tetraplegia.      The aim of this study is to determine if exposure of up to 2 hrs to cool temperatures (64°F)     causes body core temperature to decrease in persons with tetraplegia and if that decrease is     related to a decrease in mental performance.      After sitting in a cool (64°F) room for up to 2 hours the investigators hypotheses are:      Hypotheses (1): Tcore of most of the persons with tetraplegia will decline approximately     1.8°F (e.g., 98.6 to 96.8°F) while Tcore of controls will not decline at all; (2) Most of the     persons with tetraplegia will show a decline in mental performance (memory or     clear-headedness) while only some of AB controls will show a decline.      The second aim of this study is to determine if a 10 mg dose of an approved blood pressure     raising medicine (midodrine hydrochloride) will (1) reduce the decrease in body core     temperature and (2) prevent or delay the decline in mental performance in the group with     tetraplegia compared to the exact same procedures performed on the day with no medicine     (Visit 1) in the same group.      Hypotheses (3 & 4): The changes in blood flow to the skin caused by taking a one-time dose of     midodrine will lessen the decline in Tcore and prevent or delay the decline in mental     performance compared to the changes in Tcore and mental performance during cool temperature     exposure without midodrine in the group with tetraplegia.   "
111803|NCT01822522|"     This phase I trial studies the side effects and best dose of cabozantinib-s-malate in     treating patients with solid tumors that have spread to other places in the body and usually     cannot be cured or controlled with treatment and human immunodeficiency virus.     Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
111804|NCT01822509|"     This phase I/Ib trial studies the side effects and best dose of ipilimumab or nivolumab in     treating patients with cancers of the blood and blood-forming tissues (hematologic cancers)     that have returned after a period of improvement (relapsed) after donor stem cell transplant.     Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of     cancer cells to grow and spread.   "
111946|NCT01820624|"     This phase I trial studies the side effects and best dose of tretinoin when given together     with lithium carbonate in treating patients with relapsed or refractory acute myeloid     leukemia. Lithium carbonate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth. Tretinoin may help [type of cancer] cells become more like     normal cells, and to grow and spread more slowly. Giving lithium carbonate together with     tretinoin may kill more cancer cells   "
111805|NCT01822496|"     This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with     chemoradiation therapy works in treating patients with stage III non-small cell lung cancer.     Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and     cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide,     paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It     is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib     with chemoradiation therapy in treating patients with non-small cell lung cancer.   "
111806|NCT01822483|"     The purpose of this study is investigate mycophenolic acid exposure through area under the     curve in renal transplants recipients treated with mycophenolate mofetil and after conversion     to mycophenolate sodium.   "
112091|NCT01818739|"     This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph     node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer     staging and treatment.   "
111808|NCT01822457|"     This is a randomised controlled study of patients suffering from intermittent claudication     (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise     levels and quality of life.      IC manifests as pain in the calf, thigh or buttock muscles when walking. It is caused by     narrowing or blockage of the blood vessels in the legs.      The NFB is a discrete wristband with a built-in accelerometer to measure motion. It provides     estimates of the number of steps taken and the amount of distance covered each day.      This study will be conducted over a period of 18 months at Imperial College Trust's vascular     outpatients service. Patients that meet the inclusion/exclusion criteria will be asked to     consider participating. Participants will receive routine diagnostic work up with the     addition of having their walking distances measured on a lab treadmill. They will also have     their functional status and mood assessed using a questionnaire. These assessments will be     carried out a total of five times over the course of the study. Patients will not need to     make any additional visits to hospital.      Patients will be randomly allocated to either the NFB group or the control group. Patients in     the NFB group will be given a FuelBand with instructions on how to use it. All patients will     be given routine instructions on maintaining activity and target daily walking distances.     Target walking distances will be programmed into the NFB. Patients in the NFB group will be     asked to record estimates of how far they have walked each day directly from their band. All     patients will be contacted by telephone at a pre-arranged time to collect recordings.      Patients will be followed up at their routine 3-month follow up appointment and additionally     at 6 and 12 months.   "
111809|NCT01822444|"     Primary Objective:      The primary objective is to validate previously identified predictive/prognostic genomic DNA     and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced     CRC (a CRC) or metastatic CRC (mCRC).      Secondary Objective:        1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed          advanced or metastatic K-ras mutant CRC and        2. To determine the progression free and overall survival of patients under first line          FOLFOX + bvz in aCRC or mCRC.   "
111810|NCT01822431|"     This study will examine if one of the following methods: pupillometry, spectral analysis of     heart rate variability and metaiodobenzylguanidine scintigraphy, is more capable to detect     early diabetic autonomic neuropathy in patients with type 1 diabetes mellitus   "
111811|NCT01822418|"     Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders,     and several antidepressive agents have been successfully applied. The new melatonergic     antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia     for several reasons. The investigators plan to test the efficacy and tolerability of AGO for     antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27     schizophrenic patients into an open, single-armed, prospective clinical trial with     agomelatine.   "
111812|NCT01822405|"     The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of     the fibrosis.      Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical     conditions including the treatment of delayed radiation injuries (soft tissue and bony     radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation     tissue and produces angiogenesis maintained after use.   "
111813|NCT01822392|"     The research evaluates the use of online versions of delivering an effective psychological     treatment for children clinically referred for serious oppositional, aggressive, and     antisocial behavior. The goal is to develop models of delivery that reach families in need     that are not being served by in-person treatment. The project has immediate implications for     the treatment of children but more generally addresses several issues critical to treatments     that are based on Internet, telepsychiatry, and related technologies.   "
111814|NCT01822379|"     Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin     cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP     (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this     procedure to be both safe and effective for the treatment of vitiligo. The majority of these     studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme     that helps to separate the different layers of skin. However, some cell biologists believe     that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less     toxic to cells of the epidermis and can result in a greater number of viable melanocytes and     keratinocytes for transplantation.      This study will look at the repigmentation rates of MKTP using trypsin to isolate cells,     versus MKTP using dispase to isolate cells.   "
111947|NCT01820611|"     The primary purpose of this study is to evaluate the clinical performance of the Arcos     Revision Stem system, determine the stability of the implants, and evaluate any relationship     between Paprosky bone defect level and the success of the Arcos Stem.   "
111815|NCT01822366|"     The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy     (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young     adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and     Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility     study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT     intervention to be feasible and acceptable, with promising clinical outcomes. In the     feasibility study, lay counselors with no prior mental health experience delivered the     intervention with training and supervision by our team of mental health and TF-CBT experts.      Building on this initial study, the investigators are conducting a RCT to test the     effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual     care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots     organizations and local Co-Investigators in TZ and KE, both of whom are longstanding     collaborators with the investigators' US team and are located in mixed urban and rural areas,     allowing examination of effectiveness in two countries and two settings (urban/rural). Using     a task-shifting approach, in which lay individuals are trained as counselors, the     investigators will train six counselors in each country, who deliver 20 groups in each site     (10 rural, 10 urban), resulting in 320 children and adolescents (ages 7-13) who receive     TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks     (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months     post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors     from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and     these local trainers provide the TF-CBT supervision, while supervised themselves by the     US-based TF-CBT and mental health experts. The investigators expect this trial to yield     recommendations regarding an effective intervention for orphans that is acceptable, feasible,     and includes local responsibility as a means to enhance potential sustainability in Low- and     Middle-Income Countries (LAMICs). Findings will inform other efforts to scale up mental     health interventions to address the substantial mental health gap.   "
112092|NCT01818726|"     To evaluate Exjade efficacy and safety in patients with aplastic anemia and     transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive     treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment     programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.   "
111816|NCT01822353|"     In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old     children is 9%, and the most common allergen is milk. The overall food allergy has been     reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood.     In addition, it predicts later development of allergic disease such as asthma. Most of the     egg and milk allergy is transient and disappears in childhood. Currently, the standard of     care for food allergy includes strict allergen avoidance. However, oral immunotherapy has     been under investigation in children milk, egg, and wheat allergy. Previously, induction of     clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3     to 13 years. In adults, strict avoidance is still the standard care but there is also growing     interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.      The investigators aim to analyse the results of per oral immunotherapy treatment in severe     IgE-mediated egg, milk, and nut allergy in adults.      Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead     of total allergen avoidance and could desensitization thus be achieved?   "
111817|NCT01822340|"     The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/     Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and     one dose on every other week (EOW) regime administered for a period of 24 weeks initial     study.   "
111818|NCT01822327|"     This study is designed to advance our development of a treatment for cocaine dependence. The     investigators hypothesize that clients with high-risk characteristics will benefit from     enhanced levels of treatment.   "
111819|NCT01822314|"     The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel     followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or     Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based     paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions     at surgery.   "
111820|NCT01822301|"     Fat grafting represents a technique with great potential to improve outcomes in minimally     invasive facial reconstruction. Fat grafting has already been demonstrated as a safe and     minimally invasive technique over decades of widespread practice in plastic surgery. In our     current study of fat grafting for facial deformities (IRB# PRO09060101), we have treated 9     subjects without adverse event and all have had a significant improvement. Since all methods     of treatment and evaluation are the same in this study, we will be able to use the data in     our prior study as additional control data.      We hypothesize that repeating the fat grafting in subjects with previous facial fat grafts     will enable successful restoration of tissue volume and craniofacial form. Additionally, we     hypothesize that the results will be durable and subject quality of life improved.      Five (5) subjects (who were previously enrolled into IRB# PRO09060101) will be enrolled to     this single center University of Pittsburgh site research study.   "
111821|NCT01822288|"     Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction and     even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal     symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol     valerate (E2V) 1mg & medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine     estrogens & MPA.      However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack     of comparison research about their therapeutic effect on somatic symptoms, psychosomatic     symptoms, sexual dysfunction and even urinary symptoms. The knowledge of the above     therapeutic effects should be important for choosing a suitable medication. Therefore, the     aim of this study is to assess the therapeutic effect on somatic symptoms, psychosomatic     symptoms, sexual dysfunction and even urinary symptoms between tibolone and E2V/MPA.   "
111822|NCT01822275|"     In the current proposed trial the role of the low-dose WBRT (0.15 Gy) would be to safely     treat the microscopic distant GBM cells outside of the high dose RT region and sensitize the     gross tumor, while the focal radiation dose (1.85 Gy) to the gross tumor will bring the total     tumor dose of 2 Gy per fraction which is the standard of care.      Radiotherapy (RT) has been integral in the treatment of GBM since the 1970s when Walker et     al. showed that post-operative whole brain radiotherapy (WBRT) offered significant     improvements in median survival time, and even more so when given with concomitant BCNU     chemotherapy. Ensuing dose escalation studies found the optimal dose to be 60 Gy. Patients     could not tolerate escalation to higher doses than 60 Gy with WBRT due to unacceptable     toxicity. Even with WBRT of 60 Gy, a huge volume of healthy brain tissue was unnecessarily     treated with high-dose radiation; recurrences with WBRT remained overwhelmingly local.     Hochberg and Pruitt (1980) found that after WBRT only 3% of recurrences were outside 2 cm of     the margins of the primary tumor. With the rise of the CT scan in the 1980s and the MRI in     the 1990s, along with subsequent improvements in three-dimensional conformal radiation,     partial brain RT (PBRT) became practical since tumor margins could be visualized and     irradiated more accurately. - Subsequently, WBRT was shown to provide no survival benefit     over PBRT at the same dosage; - thus, the latter took over as the standard of care.   "
111823|NCT01822262|"     To explore the therapeutic effects for treatment of cholecystolithiasis by minimally invasive     cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy. Method：     patients with cholecystolithiasis who received minimally invasive Cholecystolithotomy with     gallbladder reservation and patients with cholecystolithiasis who received laparoscopic     cholecystectomy(LC) in The Affiliated Hospital of Guiyang Medical College from May 2011 to     December 2013. Patients who received minimally invasive cholecystolithotomy with gallbladder     reservation as trial group, patients who received LC as control group.the overall follow-up     period is 1 year. Then the investigators statistically analyze improvement of     cholecystolithiasis symptoms in every group, thickness of gall bladder wall, the gallbladder     function and the rate of the recurrence of cholesterol gallstone in trial group.   "
111824|NCT01822249|"     Rett syndrome is a severe neurodevelopmental disorder that primarily affects female children.     Rett syndrome is characterized by significant elevation in blood markers of oxidative stress.     EPI-743 is a novel therapeutic with demonstrated efficacy and safety in the treatment of     disorders characterized by oxidative stress. The purpose of this study is to examine the     safety and efficacy of EPI-743 in a population of children with Rett syndrome.   "
111825|NCT01822236|"     The purpose of this study is to determine whether a craniosacral therapy program are     effective on disability, quality of life, autonomic nervous system and oxidative stress     indicators in patients with chronic low back pain.   "
111827|NCT01822210|"     Preclinical studies at our institution, using a genetic mouse model of gastric cancer,     strongly suggest that innervation of the stomach wall is required not only for the     development, but also for the progression of gastric cancer, and that denervation of the     stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall     may represent an effective therapeutic intervention. New treatment options for inoperable     cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to     be an attractive possibility. In this pilot study Botox injections will be given by     gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is     to obtain data needed to calculate sample size in a larger controlled trial.   "
111828|NCT01822197|"     The purpose of this study is to determine whether bright light phototherapy can improve     depressive symptoms in hospitalized patients with cystic fibrosis (CF) with subsequent     effects on quality of life and illness recovery. It is hypothesized that phototherapy will     improve depressive symptoms and decrease length of stay in depressed patients with CF who are     hospitalized.   "
111829|NCT01822184|"     Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) is a rare, genetically linked lysosomal     storage disease (LSD) caused by deficiency of the enzyme, iduronate-2-sulfatase (I2S). Most     MPS II patients will present with some degree of neurodevelopmental involvement, ranging from     severe cognitive impairment and behavioral problems to mildly impaired cognition. This is an     observational study; no investigational treatment will be administered. The primary objective     of this study is to evaluate the neurodevelopmental status of pediatric patients with MPS II     over time and to gain information to guide future treatment studies in this patient     population.   "
111830|NCT01822171|"     Readmission to a hospital shortly after discharge is a common and costly problem. In the     United States patients with a diagnosis of heart failure currently experience an elevated 30     day readmission rate of approximately 20%. By providing patients with medication related     counseling at discharge by a pharmacist, home medications at discharge, and seeing the     patient again in a pharmacist-run Medication Therapy Management (MTM) clinic 7 days after     discharge, the study anticipates achieving its primary goal of showing a reduction in the     readmission rate. Secondary goals are: 1) to determine patients understanding of the     medication they are taking, 2) to evaluate satisfaction with the comprehensive discharge     counseling service, and 3) determine the number of interventions made and benefit of the MTM     clinic.   "
111831|NCT01822158|"     This study is to determine if using a standardized debrief checklist after vaginal delivery     improves communication between the vaginal delivery health care team members and if using the     checklist increases a sense of enhanced communication between team members.   "
111832|NCT01822145|"     The primary hypothesis is that an ICD shock may be predicted days in advance by a combined     score derived from different data obtainable from the ICD   "
111833|NCT01822132|"     The purpose of this protocol is to learn more about impulsive decision making in people who     use methamphetamines. The investigators would like to know if a medication called naltrexone     changes how people make decisions. The investigators would also like to know whether changes     in decision making can be observed by MRI (magnetic resonance imaging).      The research is conducted in Portland, OR.   "
111834|NCT01822119|"     The rationale behind this clinical performance investigation is to collect data regarding the     usability of the Baha Attract System in patients with hearing impairment that are candidates     for Baha surgery:        -  To describe the expected hearing performance with the Baha Attract in comparison to          unaided hearing thresholds or a pre-test situation using a sound processor together with          a softband        -  Which sound processor to select, i.e. BP100 vs BP110        -  Improve the fitting process for the sound processor        -  Selection of sound processor magnet at time of fitting and over time   "
111851|NCT01821898|"     Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil)     involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a     result, the esophagus becomes swollen and blocked making it difficult to swallow, and this     leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and     poor growth or weight loss in children      The main purpose of this research study is to compare the effectiveness of two different     types of treatment for EoE:        1. Oral viscous budesonide- which is a steroid medication that has been used to treat          asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation          in EoE, and        2. Specific food elimination.      The study will also be looking to see if a blood test is useful in following the progression     of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more     invasive test.   "
111835|NCT01822106|"     GERD is due to gastric content reflux to esophagus cause symptom and complication including     intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because     the changes of dietary habit, and improvement of examination skill and data analysis, the     prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is     25% in Taiwan community.      Although proton pump inhibitor (PPI) can inhibit gastric acid secretion, relief symptom and     enhancing repair of esophageal damage, therefore, PPI is a main drug for the treatment of     GRED, but because of PPI has disadvantage of poor compliance, and slow gastric empty time and     hypersensitivity, and about 40-50% of GERD patients is inefficacy. In addition, PPI produces     bone fracture, community pneumonia and diarrhea in patient with long-term use.      Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng),     Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger). According to     I-Fang-Chi-Chieh and Shanghonzobinglun recordings that Wu-Chu-Yu tang can treat vomiting,     and also can relax gastric tonicity and can enhance peristalsis of stomach.      Therefore, the purpose of the present study was to investigate the efficacy of Wu-Chu-Yu tang     on GRED, and this effect of Wu-Chu-Yu tang compared to PPI Omeprazole.   "
111836|NCT01822093|"     Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response     post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral     therapy without toxicity or increasing the occurrence of Graft Versus Host Disease. This is a     Phase I/IIa open-label safety study, assessing the effects of administering     adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post haematopoietic stem     cell transplant.   "
111841|NCT01822028|"     Cross-over, tolerability study with healthy subjects taking Zavesca in combination with     Florastor. Forty-two subjects will be randomized to one of two treatment sequences of Zavesca     with Florastor and Zavesca with Placebo of Florastor. Gastrointestinal tolerability and PK     endpoints, demographic, laboratory and safety testing, and AEs and SAEs will be collected     throughout the seventy-four day study.   "
111842|NCT01822015|"     This pilot clinical trial studies sirolimus, idarubicin, and cytarabine in treating patients     with newly diagnosed acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. Giving sirolimus together with     idarubicin and cytarabine may kill more cancer cells.   "
111843|NCT01822002|"     To determine the immediate therapeutic efficacies of canalith repositioning maneuvers in each     type of BPPV (posterior canal type, apogeotropic horizontal canal type and geotropic     horizontal canal type).   "
111844|NCT01821989|"     Hypothesis:      Orally ingested lactoferrin has effects on promotion of growth and differentiation of the     immature gut; also it has immunomodulatory properties, so it will prevent serious infections     in preterm infants.      The aim of the study is to:        -  Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.        -  Compare two dose regiment of lactoferrin supplementation.        -  Study effect of lactoferrin supplementation on serum iron stores.      It is a prospective, randomized, double blind, placebo-controlled study, it will include 180     preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University     Hospitals and Manshiet El Bakry Hospital.      •Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.      •Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice     daily.      •Group C (Controls): Who match the subjected neonates, will receive placebo in form of     distilled water.   "
111845|NCT01821976|"     The goals of the TAOS study is to determine the best procedures for below the knee     amputations. There are two different procedures currently used by surgeons around the county:     the Erlt procedure and the Burgess procedure. Proponents of the Ertl procedure advocate that     the surgical formation of a tibia to fibula bone bridge provides stability, shape and weight     bearing capability to the residual limb that result in less pain and better prosthetic fit     and alignment. This procedure is popular especially among the military but it's advantages     over the Burgess procedure are not well supported by current research. This study aims to     compare the two amputation procedures in an adequately powered randomized trial.   "
111846|NCT01821963|"     The goal of this clinical research study is to learn if the antiviral combination of     telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the     virus from coming back after the liver transplant.      Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at     different stages of the HCV infection to stop the virus.   "
111847|NCT01821950|"     This study will evaluate the efficacy of yoga taught during school to positively influence     risk and protective factors of substance use and the initiation and severity of substance     use. The study hypothesis is that, compared to a control group participating in regular     physical education classes, subjects who participate in 32 yoga sessions across an academic     year will improve in negative internalizing behaviors and self-regulatory skills that are     known risk and protective factors for substance use. This study will also test the hypothesis     that the yoga intervention will reduce both severity of substance use and the degree of     substance use initiation.   "
111848|NCT01821937|"     The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single     oral dose and multiple oral doses in Chinese subjects   "
111853|NCT01821872|"     Despite its use for decades all over the world, the exact mechanism of action of paracetamol     is not fully understood and essentially involves a combination of hypotheses. It is known to     have an effect via the central nervous system, and of the many mechanisms proposed, one     hypothesis is that it may have indirectly activate CB1 (cannabinoid) receptors, through its     novel metabolite AM404.      This study aims to elucidate cerebrospinal levels of paracetamol and to measure the     concentration of its metabolites, including AM404 in CSF. This may, in turn, give us useful     information on the mechanism of action of paracetamol.   "
111854|NCT01821859|"     The protocol will study the effect of the combination of two drugs—Abraxane and     Bevacizumab—on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal     cancer. This study drug combination will be given to subjects who have already been treated     for their cancer with other chemotherapy, and now their cancer has become worse or has come     back again. Neither one of these study drugs has been approved by the FDA for treatment in     these three types of cancer.   "
111855|NCT01821846|"     This trial is conducted in Asia. The aim of this study is to investigate the safety profile     of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2     diabetes mellitus.   "
111856|NCT01821833|"     Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side     effects including neuropathy (weakness, numbness and pain) and generalized body aches. The     latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and     often occurs in the first three to four days after administration. It affects about 58-90% of     patients. Currently, the mechanism of P-APS is unknown, and there is no standard of care to     treat it. However, an intervention with both anti-inflammatory as well as neuroprotective     properties would be an ideal candidate for testing in the prevention of P-APS and subsequent     development of peripheral neuropathy. Previous studies have suggested that omega-3 fatty     acids may act as neuroprotective agents, and there are no currently documented safety     concerns with their combined use with paclitaxel.      Therefore, this randomized pilot clinical trial will determine whether omega-3 fatty acids     can treat pain in patients with breast or ovarian cancer receiving paclitaxel.   "
111857|NCT01821820|"     Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling     intensely for 75 kilometers will support substrate utilization during exercise (as determined     through metabolomics) and improve performance compared to water only, and attenuate     inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.   "
111858|NCT01821807|"     The aim of the study is to observe the rate of postdural puncture headache observed after     spinal anesthesia in cesarean section patients.      Two kind of spinal anesthesia needles will be used:        1. 26 Gauge Quincke (cutting-tip needle)        2. 26 Gauge Atraucan (atraumatic needle)      The investigators will observe:        1. Number of spinal punctures        2. Time required for the spinal anesthesia procedure      Patients will be evaluated after 7 days for:        1. Headache        2. Backache   "
111859|NCT01821781|"     This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will     establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity     in patients with immune function disorders. A regimen that maximizes host immune suppression     is expected to reduce graft rejection and optimize donor cell engraftment.   "
111860|NCT01821768|"     This randomized clinical trial studies two different tests that are currently being used to     detect the spread of breast cancer to the lymph nodes under the arm in candidates for breast     conservation therapy. The two tests are sentinel lymph node biopsy (SLNB) and axillary     ultrasound. The current standard of care is sentinel lymph node biopsy, which is a surgical     procedure. Axillary ultrasound (AUS) may be just as good as SLNB for detecting the spread of     cancer but without the surgical risks.   "
111861|NCT01821755|"     The hypothesis of the study is that the intervention leads to a reduction in foster     children's externalizing problems and foster parents' parenting stress and that this in turn     leads to a reduction in the number of breakdowns of foster placements.   "
111862|NCT01821742|"     A study to determine if echocardiographically derived parameters, plethysmographic     variability index and pulse pressure variation predict fluid responsiveness in children on     PICU.   "
111863|NCT01821729|"     This is a Phase II clinical trial, which tests the safety and effectiveness of an     investigational combination of drugs to learn whether the combination of drugs works in     treating a specific cancer. Investigational means that the combination of drugs is being     studied. It also means that the FDA has not yet approved it for your type of cancer. Proton     beam radiation therapy is an FDA approved radiation delivery system.      Conventional radiation therapy uses photons to treat cancer before patients undergo surgery     to remove the tumor. In this study we are using radiation with protons, which spares     surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area     requiring radiation with no dose beyond the treatment area. This may reduce side effects that     patients would normally experience with conventional radiation therapy.      Researchers in the laboratory have discovered pathways inside cancer cells which contribute     to the growth and survival of tumors. The FOLFIRINOX chemotherapy regimen is a combination of     the drugs 5-fluorouracil, leucovorin and oxaliplatin. These chemotherapy drugs, along with     the chemotherapy drug capecitabine, work by blocking these pathways and thereby preventing     tumor growth. Capecitabine is FDA approved to be used alone or with other drugs to treat     other types of advanced cancer, but not pancreatic cancer. In past research studies,     FOLFIRINOX followed by radiation therapy with capecitabine has been identified as the most     effective and active chemotherapy for patients with cancer that is spreading, and this is why     we are using it to treat your type of cancer.      Losartan is classified as an angiotensin-receptor blocker (ARB), and is FDA approved for use     in people with high blood pressure. Recent studies in people with different types of cancer,     including pancreatic cancer, have shown that combining chemotherapy drugs with an ARB can     help reduce/stop tumor growth more effectively than chemotherapy alone. Losartan has been     used in previous research studies, and information from those research studies suggests that     this drug in combination with FOLFIRINOX and capecitabine may be better at treating your type     of cancer.      In this research study, we seek to determine whether combining FOLFIRINOX with Losartan     before proton radiation therapy will be more efficient at controlling the growth of or     shrinking your tumor than just FOLFIRINOX alone.   "
111864|NCT01821716|"     The objective of this study is to determine the biologic activity of a Dermatophagoides     pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used     as in-house reference preparation (IHRP).   "
111865|NCT01821703|"     The purpose of this study is to investigate the safety and tolerability of LY3045697 after     multiple doses and to determine how long LY3045697 remains in the body. Each participant is     expected to complete 3 dosing periods. At least 7 days will pass between dosing periods.   "
111866|NCT01821690|"     The purpose of this study is to improve behavior control displayed by persons with traumatic     brain injury by assessing effectiveness of treatments for post-TBI irritability and     aggression.   "
112605|NCT01812018|"     The purpose of this exploratory phase II study is to assess the effectiveness and safety     profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel     in treatment of soft tissue sarcoma patients with pulmonary metastases.   "
111867|NCT01821677|"     This study will evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of     diabetic macular edema versus placebo. Optina has already been granted 505(b)2 status by the     FDA and will incorporate all safety data from prior FDA approvals. Additional safety data     will be collected specifically for this low dosage.      This study will identify a population of subjects where Optina demonstrates a therapeutic     effect.      A portion of 505(b)2 drugs are approved based on a single clinical trial.   "
111868|NCT01821664|"     Background: Vascular grafts are increasingly implanted due to an increasing prevalence of     atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by     infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high.     However, there are almost no data regarding best treatment options of such complicated     infections. Most recommendations are based on expert opinion and not on clinical trials or     cohort observational data analyses. Evaluating infectious and other complications after     vascular surgery procedures are important, and additionally, such studies may offer insights     for quality improvement and improved patient outcomes. With the first aim investigators will     establish an infrastructure for studying PVGI in Zurich. Investigators will take advantage of     the Swissvasc registry, a central registry which collects preoperative, operative and     discharge data regarding the index vascular surgical interventions. They will create a     prospective observational cohort database of all patients who receive a vascular graft     (peripheral, aortic, vein) at the University hospital of Zurich (VASGRA Cohort A). Patients     with a PVGI will be included in VASGRA Cohort B and followed up using a flow chart with a     focus on the course of this infectious complication. Additionally, investigators will     establish a biobank with the collection of tissue- and blood samples of patients with PVGI.     With the second aim researchers will investigate different diagnostic, clinical and     therapeutic research questions nested in the VASGRA Cohort. Firstly, they will address     epidemiological questions, such as: determine the incidence and outcome of complications     after vascular graft placement; determine risk factors, best treatment strategies and outcome     of PVGI, and determine the influence of different antibiotic regimens on the outcome of PVGI     due to different bacterial pathogens. Secondly, investigators will determine the accuracy of     different imaging techniques (PET/CT and MRI) for the diagnosis of PVGI, and their individual     role for the assessment of treatment response. Thirdly, investigators will evaluate the     bacterial diversity of vascular wound infections using 16s r-Ribonucleic acid     (RNA)amplification, and investigators will explore whether this bacterial diversity does     predict disease progression. Here, investigators will also study the impact of negative     pressure wound therapy (NPWT) on bacterial diversity in the treatment course of PVGI.     Fourthly, investigators will look for cut-off levels of relevant blood leucocytes count,     C-reactive protein and procalcitonin raising suspicion of a PVGI. Lastly, investigators will     look at histopathological features of excised vascular grafts. Expected value of the project:     Results from the proposed study are an important contribution to the field, based on the     large sample size, longitudinal design and by unifying clinical and epidemiological science.     The very well characterized patient groups and the close connection between vascular     surgeons, infectious disease specialists, specialists in nuclear medicine and microbiologist     will help to investigate PVGI in depths. Investigators hope to be able to develop guidelines     regarding best diagnostic modalities and treatment options in case of vascular graft     infections. In the future we plan to examine bacteria retrieved from the PVGI in the     laboratory in detail. The recovered bacteria will be examined for antimicrobial     susceptibility and their capability to form biofilms. Furthermore investigators will examine     how bacterial recovery form explanted grafts could be optimized.   "
111869|NCT01821651|"     Objectives:      Goal of the study is to investigate the potential benefit that transcatheter interventions     such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage     Closure and catheter Ablation can gain from multimodal image fusion techniques as they are     available in the Hybrid suite.      Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and     contrast agent, to shorten the operation time (efficacy), and to increase the quality of care     (safety).      This pilot study aims at observing these aims on a small patient population and a control     group.      Number of Subjects:      140 patients total in 6 groups:        -  MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in          stage).        -  MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).        -  TAVI with HeartNavigator lead in (10)        -  TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).   "
111870|NCT01821638|"     Cognitive impairment, commonly reported as difficulty with memory and executive function, is     a widely recognized clinical challenge for older persons with heart failure (HF). Little is     known about the relationship between brain MRI and cognitive impairment in older persons with     HF. A limited number of studies have investigated brain MRI in adults with HF and produced     conflicting results. Previous findings are limited by use of lower resolution scanners (1.5     Tesla), lack of MRI techniques (i.e. combining structural sequences with perfusion sequences)     and recruitment of mixed age samples. Based on these limitations, the purpose of this     research plan is to explore the relationship between brain MRI and cognitive impairment in     older persons with HF using high resolution structural and perfusion scans. To accomplish     this goal, investigators will compare 40 adults with HF who are age > 65 years old with 40     healthy, gender, age, and education matched controls. Investigators will obtain     neuropsychological measures of multiple domains, as well as MRI measurements of the temporal     lobe and prefrontal cortex at baseline and 12-months.   "
111871|NCT01821625|"     This study will provide chronic hepatitis C (CHC) patients with low platelets (less than     75x10^9/L) the opportunity to undergo treatment and possible cure of their virus. The main     hepatitis C drugs will be administered as standard of care, with the addition of the study     drug eltrombopag.      The investigators hypothesize that providing eltrombopag to CHC patients with low platelets     (less than 75x10^9/L) will permit the initiation and completion of antiviral triple therapy     with boceprevir, ribavirin, and pegylated-interferon.   "
111872|NCT01821612|"     This pilot clinical trial studies combination chemotherapy and radiation therapy before     surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer.     Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin     calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination     chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill     any tumor cells that remain after surgery.   "
111873|NCT01821599|"     The accelerated rehabilitation and early return does not seem to be harmful, but still needs     further research to define the rehabilitation time is what shows Kruse and collaborators     (2012) in their study of systematic review. The surgical treatment of anterior cruciate     ligament injury is the gold standard in the treatment of these injuries in young and active,     the postoperative rehabilitation is extensive and full return to sport occurs only after 6     months postoperatively. Based on this gap, the investigators seek to draw properly through     our study methods and more complex techniques, that comparing two rehabilitation programs can     achieve high precision early rehabilitation. This will include 32 athletes who had complete     ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All     subjects will be followed from the pre-surgery, the fourth and sixth month after surgery     with: KT1000 measures the ligamentous laxity, knee function by applying the International     Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a     random draw of sealed envelopes, patients will be allocated in their rehabilitation groups:     Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month     after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee     function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to     treatment group. This study will have the locus Institute of Orthopaedics and Traumatology,     School of Medicine, São Paulo. The comparative results of the two groups are analyzed using     specific statistical tests to prove an improved significative without damaging the integrity     of the graft.   "
111883|NCT01821469|"     This research project follows two main objectives: 1) Assess anatomical and functional     cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes     after the application of a psychoeducational program in these patients. Specifically, this     project aims to assess neurophysiological (fMRI - activation and functional connectivity) and     neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar     disorders and the therapeutic response to the psychoeducation. The results of this thesis     project would also contribute to the validation of a pathophysiological model of the bipolar     disorder.   "
111884|NCT01821456|"     The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study     assessing risk factors, interventions, and outcome of immunosuppressed patients with or     without opportunistic infections.   "
111948|NCT01820598|"     The study was designed to test the following hypotheses:      In patients with severe obesity, a multisite electrostimulation session (m-NMES) will induce     higher changes in metabolic, inflammatory and cardiovascular parameters and higher increase     in muscle strength during stimulated contractions than conventional unidirectional     electrostimulation session (c-NMES).      In patients with severe obesity, a six-weeks m-NMES training program will enhance     cardiovascular, metabolic and inflammatory parameters.   "
111874|NCT01821586|"     Diarrhoea and malnutrition are the common childhood illnesses responsible for higher deaths     in developing counties. Physiologically, malnourished children excrete lower amounts of salts     and water in diarrhoeal stools, and they also are unable to handle excessive salts and water     load. Some times they are found to be hyponatraemic due to the shift of sodium inside the     cells (inefficient Na+ /K+ pump), and fluids containing higher amounts of sodium (such as the     standard ORS) may lead to further increase in the intracellular sodium, fluid overload and     heart failure. They also have depleted in potassium stores in the body. Recently, the WHO     recommended a special ORS formulation, known as ReSoMal, for management of diarrhoea in     severely malnourished children that contains a lower amount of sodium (45mmol/L) and higher     amount of potassium (40 mmol/L) than the standard WHO-ORS. It is felt that an ORS containing     lower sodium and higher potassium concentration may be useful in correcting hypokalemia, and     in lowering the risks of excess sodium and /or overhydration, in severely malnourished     children with diarrhoea. The safety of ReSoMaL is, however, still in question due to the risk     of hyponatraemia, including symptomatic hyponatraemia, especially in the treatment of severe     watery diarrhoea due to Vibrio cholerae and ETEC where loss of sodium in the stool exceeds     than that is contained in ReSoMal. Thus an ORS solution with modest concentration of sodium     (75 mmol/L) and higher concentration of potassium (40 mmol/L) have been suggested for the     treatment of diarrhoea in these children. To improve the efficacy of oral rehydration, in     terms of reducing the severity of purging and diarrhoea duration, different approaches     (changing the substrates/ reducing the sodium and glucose concentration and osmolarity) have     been tried with limited success. Benefiber (partially hydrolysed guar gum), a soluble fiber     if added to a ORS solution is expected to be fermented in the colon liberating short chain     fatty acids (SCFAs). SCFAs stimulate sodium and water absorption from the colon, and they     have trophic effect, act as a fuel source for the colonocytes, have antibacterial properties     and stimulates the production commensal flora, thereby may enhance recovery from acute     diarrhoea in severely malnourished children. The aims of our proposed study are to examine     whether an ORS solution with a modest concentration of sodium will prevent the occurrence of     hyponatraemia including symptomatic hyponatraemia, and also whether addition of benefiber     will improve the efficacy of ORS solution. This will be a randomized, double blind,     controlled clinical trial in 186 children with severe malnutrition and watery diarrhoea (62     in each of the three treatment groups) to compare the efficacy of (i) the currently     recommended ORS with some modofication(Na+ 75 mmol/L and K40 momol/L and minerals-Zinc,     copper and magnesium), (ii) ReSoMal (Na+ 45 mmol/L), (iii) Currently recommended ORS (Na+ 75     mmol/L, K 40 momol/L and added minerals) with added Benefiber (25 grams/L), in the treatment     of acute watery diarrhoea in children with severe malnutrition   "
111875|NCT01821573|"     The aim of this randomized controlled study is to quantify the modification during locomotion     of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps     Surae induced by botulinum toxin injection type A.      The main hypotheses of this study based on previous studies are that botulinum toxin     injection increases on one hand the length of the muscle injected during gait and on the     other hand decreased the strength of the muscles injected.      The investigators also hypothesized that botulinum toxin injection improved the strength of     the antagonist muscles and normalized the pattern of strength of the muscles injected during     gait.   "
112562|NCT01812590|"     Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient     hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise     bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.   "
111876|NCT01821560|"     The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a     functional candidate gene association approach (of dopaminergic addictions-targeted     polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor     agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive     smoking reminders (cues that motivate continued smoking and relapse). These studies will     provide a means to identify an appetitive cue-sensitive pharmacologic-responsive     endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to     treatment, smoking cessation treatments can be structured to meet individual needs, which     will significantly improve treatment outcome.   "
111877|NCT01821547|"     Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because     of this it is a useful vaccine in which to develop new methods for studying immune responses.     Measuring the immune response to vaccines helps us to understand how they work and whether     they are likely to protect any individual against infection. For most vaccines we measure the     immune system's production of antibody after a vaccine has been given. The investigators want     to develop new methods that give a far more detailed picture of the antibody response to     vaccines than has previously been possible. These methods will investigate the genetic     instructions used by each antibody producing cell to make antibody. These methods have the     potential to give new insights into the way vaccines work, which could be applied to studying     vaccines and vaccine schedules in the future.   "
111878|NCT01821534|"     This study will evaluate the inter-rater and intra-rater reliability of a Masseter Muscle     Prominence Scale for evaluating a patient's muscle prominence and a Lower Shape     Classification for evaluating a patient's lower facial shape.   "
111879|NCT01821521|"     Primary object : Evaluate pharmacokinetic property administered S-pantoprazole 20mg and     Pantoprazole 40mg in healthy male subjects      Secondary object : Evaluate safety administered S-pantoprazole 20mg and Pantoprazole 40mg in     healthy male subjects   "
111880|NCT01821508|"     This is a prospective, open, randomized study involving 72 patients with microvascular     complications of type 2 diabetes mellitus and obesity, who will undergo gastric bypass     (Roux-en-Y gastric bypass ARM A) or receive best medical treatment (ARM B, control arm).      The aim of this study is to evaluate the effects of Roux-en-Y gastric bypass in the control     of diabetic nephropathy in diabetic patients with BMI between 30 and 35 kg/m2.      The medical community is confronted with many different studies using various methodologies     to investigate the best pharmacological treatment for type 2 diabetes mellitus. The treatment     algorithm offers several different options according to the stage of the disease (which is     different in each study). In addition, new drugs are being developed over the years, but are     not always a guarantee of effective type 2 diabetes mellitus control [MENDES, 2010].     Furthermore, these drugs do not prevent the development of this disease, consequently     increasing the risks of microvascular and macrovascular complications.      Conversely, there is considerable evidence that surgery can be an adequate tool to promote     type 2 diabetes mellitus remission in patients who are unresponsive to clinical treatment.     Gastric bypass surgery is one of the most popular bariatric surgeries in the world, but its     effects on microvascular and macrovascular complications of type 2 diabetes mellitus have not     been established. Specialists suggest that the rapid and uncontrollable decrease in blood     glucose adds to the concern that the surgery may paradoxically cause exacerbation of     microvascular complications [LEOW, 2005], whereas gradual improvement in blood glucose before     gastric bypass surgery may prevent this paradoxical worsening, leading to an interruption of     this process, or even retinopathy, nephropathy, and neuropathy remission.      However, there are no studies comparing the results of these two types of treatment (clinical     vs. surgical) in a similar population and assessing the development of microvascular     complications of type 2 diabetes mellitus. Therefore, in order to clarify such doubts, it is     necessary and extremely desirable to conduct a randomized controlled trial comparing gastric     bypass with the best and most modern clinical treatment. Its findings could have a direct     impact on hundreds of millions of diabetics by allowing the inclusion of surgical treatment     as a safe and feasible therapeutic option for a significant portion of these patients.   "
111881|NCT01821495|"     Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with     nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment     failure. A series of studies reported that dendritic and cytokine-induced killer cells     (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis     of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after     concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the     efficacy of DC-CIK for NPC.   "
111882|NCT01821482|"     The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced     Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).   "
112003|NCT01819883|"     This study investigates fat distribution in people with acromegaly. The investigator is also     investigating the change of fat distribution before and after treatment of acromegaly. The     investigator will compare the results of people with acromegaly to the results of healthy     volunteers.   "
111885|NCT01821443|"     The purpose of this study is to find out what effects, good and/or bad, stereotactic     radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of     giving radiation therapy to the brain in a very focused way, so that nearby parts of the     brain receive very little exposure to radiation. No incisions are involved. Imaging     technology is used to pinpoint the location of the tumor.      In this study, the investigators are also trying to find out how the tumor and/or treatment     affect brain function over time. The investigators will do this by performing a series of     neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before     treatment and at regular intervals after treatment.   "
111886|NCT01821430|"     Managing pain in patients who abuse prescription opioids presents many challenges, including     the development of opioid-induced hyperalgesia (OIH). Hyperalgesia is a condition in which     something that usually feels slightly painful is perceived as something very painful. The     proposed study will test the efficacy of the well-known neurological medication pregabalin to     diminish OIH and chronic pain in persons who are in Suboxone (buprenorphine) or methadone     treatment for prescription drug abuse.   "
111887|NCT01821417|"     The study will compare initial peri-implant bone healing and longitudinal osseointegration     between a fully microtextured dental implant and an analogous implant with a smooth machined     collar.      The investigators hypothesize the fully textured implant will result in less peri-implant     crestal bone resorption than the implant with a machined collar.   "
111888|NCT01821404|"     This single-center, randomized, double-blind trial assesses the impact of short-term     atorvastatin administration on proliferation activity, apoptotic rate and histological     inflammation in prostate tissue.   "
111889|NCT01821391|"     This study will be conducted as a multi-centre, randomized, investigator-blind, active and     vehicle-controlled, intra-individual study.      The purpose of this study is to confirm that the Metvix NDL-PDT procedure is similar in     efficacy and less painful when compared to Metvix c-PDT procedure for the treatment of mild     and moderate AKs.      In addition this study will include a Metvix NDL-PDT arm versus Metvix vehicle cream c PDT     (Placebo) to assess the sensitivity of the trial.   "
111891|NCT01821365|"     Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when     people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect     the level of PaCO2,but some investigators found that PETCO2 measurements did not reflect     PaCO2 in COPD patients.There may be several reasons for this discrepancy. Due to airway     obstruction and ventilation-perfusion mismatch, there is a delay in the maximum alveolar     concentration of CO2 reaching the cannula, which may give lower PETCO2 values compared with     PaCO2. To overcome this disadvantage, we tried to prolong their expiratory time (extend to     5-8s) in order to guarantee adequate time for alveolar CO2 reaching the cannula.our study     mainly focus on two issues.First, to explore the optimal depth of tube placed when patients     with COPD breathe spontaneously or receive noninvasive ventilation, and compare the     differences of two condition at the same time. Secondly, to evaluate the agreement between     the PaCO2 and sidestream PETCO2（5s）values in COPD patients receiving noninvasive ventilation     when our extension tube locates in the optimal position, and investigate whether     PETCO2（5s）can be used to monitor ventilation status dynamically.   "
111892|NCT01821352|"     The purpose of this study is to determine whether low level laser light therapy is effective     in reducing circumference of the waist, hips and upper abdomen in obese individuals.   "
111893|NCT01821339|"     The purpose of this study is to determine whether displacement on one or all of the standard     radiography views done within 6 months and 1 year after a pelvic injury is related to health     related quality of life outcomes of patients with an isolated pelvic ring injury.   "
111894|NCT01821326|"     The investigators investigated the rebleeding rate the risk factors for rebleeding after     long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure     gastrointestinal bleeding.   "
111895|NCT01821313|"     The purpose of this study is to examine the effects of high intensity interval exercise     (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our     working hypothesis is that, compared with obese children prescribed moderate exercise, obese     children prescribed HIIE will demonstrate greater improvements in endothelial function and     inflammatory markers following a 6-week exercise intervention.   "
111896|NCT01821300|"     The purpose of this research study is to determine which measures best capture cardiovascular     disease (CVD) risk and type 2 diabetes (T2DM) risk in children and adolescents with Down     syndrome (DS).      We hypothesize that DS is associated with worse cardiometabolic risk factors for a given body     mass index compared to controls. This difference arises at least in part, from increased fat     tissue.   "
111897|NCT01821287|"     The purpose of this study is to understand the causes of growth failure and to define     biochemical markers of nutritional failure in patients with single ventricle Congenital Heart     Disease (CHD).   "
111898|NCT01821274|"     The purpose of the study is to determine whether Diltiazem Hydrochloride 2% Cream will cause     irritation to skin on the back of healthy volunteers after repeated application over 21-days.   "
111899|NCT01821248|"     To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/     Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.   "
111900|NCT01821235|"     The NO SWITCH list is based on the hypothesis that the pharmacokinetic differences between     different batches of one medicines are smaller than the pharmacokinetic differences between     two medicines (from a different manufacturer, e.g. brand versus generic medicine). The aim of     this study is to investigate the hypothesis using gabapentin as test product. Therefore, the     first objective of this study is to investigate the individual bioequivalence - or     switchability - of Gabasandoz® 800 mg relative to Neurontin 800 mg®. The second objective is     to investigate the individual bioequivalence between two different batches of the same     medicine, for Gabasandoz® 800 mg and Neurontin® 800 mg.   "
111949|NCT01820585|"     This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre,     multinational, Phase II study in 528 subjects with pain due to Fibromyalgia syndrome(FMS).     Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate (ESL)     400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as     follows.   "
111901|NCT01821222|"     Reducing maternal and newborn mortality remains a global challenge. Because obstetric     complications cannot be predicted, skilled attendance at the time of delivery and access to     emergency obstetric care remain the most effective strategies to reduce mortality. Antenatal     care has the potential to reduce maternal morbidity and improve newborns survival but this     benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is     declining. There is a rapidly expanding number of mobile phone users in developing countries     and due to the potential to strengthen health system the use of mobile phones is health care     is emerging. The investigators assessed a mobile phone intervention named wired mothers     aimed to improve maternal and newborn health.      The hypothesis of the study was that the wired mothers mobile phone intervention would     increase attendance to essential reproductive health services such as antenatal care and     skilled delivery attendance and reduce severe adverse pregnancy outcomes for women and     newborn.      The objective of the study was to examine the effect of the wired mothers intervention on     antenatal care, skilled delivery attendance, access to emergency obstetric care and perinatal     mortality.      The study was a pragmatic cluster randomized controlled trial with the primary health care     facility as the unit of randomization. The study took place in 2009-2010 on the island of     Unguja in Zanzibar. 2550 pregnant women who attended antenatal care at one of 24 selected     facilities were included at their first visit and followed until 42 days after delivery.     Facilities were allocated by simple randomization to either mobile phone intervention (n=12)     or standard care (n=12). The intervention consisted of a SMS and mobile phone voucher     component.      The perspectives of the study are that mobile phones may contribute to saving the lives of     women and their newborns and achievement of MDGs 4 and 5. Evidence is needed to guide     maternal and child health policy makers in developing countries.   "
111902|NCT01821209|"     Placement of an autologous retropubic urethral sling at the time of robot assisted radical     prostatectomy will improve the recovery of continence after radical prostatectomy   "
111903|NCT01821196|"     Preclinical studies at our institution, based on a genetic mouse model of stomach cancer,     strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of     stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by     injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer     as well as reduces already established tumor volume in the stomach in this mouse model. Gene     expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The     expression of PGP9.5 is highly specific for the density of neurons and the diffuse     neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal     mucosa either by means of endoscopy and/or from operative specimens from participants treated     or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs     Hospital, Trondheim University Hospital. The biopsies will be evaluated with     immunohistochemistry and gene expression studies for the presence and density of PGP9.5.     These data will be correlated to stage evaluation (TNM) and survival.   "
111905|NCT01821170|"     The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most     frequently found disorder in children. It is characterized by a triad of symptoms involving     attention deficit, hyperactivity and impulsivity and having an impact on the functioning of     the subject especially in terms of learning.      Currently, main interventions to treat ADHD in children are stimulant medication or     supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs     (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD     children. These drugs are generally effective but their nature (psychostimulants) and adverse     effects they cause (appetite suppression, sleep disturbances, headaches, motor tics,     abdominal pain, irritability, nausea and fatigue) encourage the development of new     therapeutic approaches. The use of supportive psychotherapy alone would have limited effect     on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program     using a virtual classroom in children suffering from ADHD.   "
111906|NCT01821157|"     The aim of this study is to compare the clinical outcomes of open-flap (OF) and flapless (FL)     esthetic crown lengthening (ECL) for the treatment of excessive gingival display (EGD). It     was hypothesized that the FL surgery would yield similar clinical results to the OF technique     up to 12 months. Methods: A split-mouth randomized controlled trial will be conducted in 28     subjects presenting EGD. Contralateral quadrants will receive ECL using OF or FL techniques.     Clinical parameters will be evaluated at baseline, 3, 6 and 12 months post-surgeries. The     local levels of receptor activator of NF-КB ligand (RANKL) and osteoprotegerin (OPG) will be     assessed by ELISA at baseline and 3 months. Patients' perceptions regarding morbidity and     esthetical appearance will be also evaluated. Periodontal tissue dimensions will be obtained     by computed tomography at baseline and correlated with the changes in the gingival margin     (GM).   "
111907|NCT01821144|"     The study is to test whether an education programme targeted at school children can lower     salt intake in children and their families. In this study, the investigators will educate     children on how to reduce salt intake, and the investigators will empower children by asking     them to deliver the salt reduction message home to their families, particularly children need     to persuade the person who does the cooking for the whole family to cut down on the amount of     salt used during food preparations. The study will involve children aged about 11 years, and     their parents and grandparents in Northern China.   "
111908|NCT01821131|"     This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities     of flax. The purpose of this study is to find the lowest dose of flax that can lower     LDL-cholesterol.   "
111909|NCT01821118|"     Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called     amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood     vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more     hemorrhages in the brain cortex in individuals 55 years of age or older. This study will     examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the     maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30     and 60. Subjects will be followed for 6 months after receiving the last dose of study     medication.   "
111910|NCT01821105|"     This pilot phase II studies how well computed tomography (CT) and positron emission     tomography (PET) imaging works in detecting disease in patients undergoing surgery for     metastatic colorectal cancer. Diagnostic procedures, such as CT and PET scans, done before     and during surgery may help find colorectal cancer and help guide surgery   "
111950|NCT01820572|"     The primary purpose is to assess the benefits and risks of changing from Cyclosporine or     Tacrolimus to Belatacept between 6-60 months after kidney transplant.   "
112004|NCT01819870|"     The purpose of this study is to compare the pharmacokinetic characteristics and safety of     dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.   "
111911|NCT01821092|"     40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic     area (from second premolar to second premolar) will be enrolled in the study. At the time of     surgery, a full thickness flap will be elevated, the implant bed will be prepared according     to the manufacturer's instruction and the implants will be then seated into the bone. T0     corresponds to the time of implant insertion, T1 to the time of healing abutment's connection     (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from healing     abutment's connection.      Cone Beam Computed Tomography (CBCT) scans will be taken immediately after abutment     connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be     identified, and measurements will be made at predetermined levels. Horizontal facial bone     thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be     measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular     distance from the implant platform to the most coronal point of the facial bone. Changes     between T1 and T2 will be calculated.   "
111912|NCT01821079|"     The purpose of this study in healthy volunteers is to assess the relative bioavailability of     PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the     pharmacokinetics of the tablet formulation.   "
111913|NCT01821066|"     A single 125 mg oral dose of the investigational compound PD-0332991 will be administered     alone and after steady-state dosing of tamoxifen to determine if coadministration of     tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.   "
111914|NCT01821053|"     A tonic active epithelial Na+ channel (ENaC) in pre-eclampsia (PE) escaped normal hormonal     control may offer an attractive explanatory model for the pathophysiology of established PE.     The channel is activated by plasmin. Microalbuminuria predicts the development of     pre-eclampsia in pregnant patients with pregestational diabetes type 1. The investigators     hypothesize that urine-plasmin excreted in the kidneys, when proteinuria occurs, could be the     cause. The investigators want to test the correlation between measurable plasmin/plasminogen     in the urine early in pregnancy and the development of preeclampsia in pregnant patients with     type 1 diabetes.   "
111915|NCT01821040|"     The study compares the efficacy and safety of modified release prednisone versus immediate     release prednisone in patients suffering from polymyalgia rheumatica.   "
111916|NCT01821027|"     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)     affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how     the drug affects the body) of a single dose of simvastatin.   "
111917|NCT01821014|"     Much of the basic general medical care and chronic disease management in rural Honduras comes     from groups of volunteers setting up temporary clinics run by volunteers. These clinics, also     known as brigades, or medical missions, are often criticized for their lack of quality and     the lack of follow-up, both of which stem, in part, from understaffing with volunteer     physicians. This study is designed to assess if it is feasible, safe, and acceptable to treat     patients in short-term mobile medical clinics in rural Honduras using US physicians connected     with patients by videoconference.   "
111918|NCT01821001|"     Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms     including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for     adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as     a therapy based on animal models of the disease and our prior clinical research to observe     any objective improvement in the extent of the disease using Magnetic Resonance Imaging     (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.   "
111919|NCT01820988|"     The objective of this cross-sectional study is to obtain insight in the characteristics     (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic     community-dwelling older people. There is one measurement moment and measurements will take     place at the participant's home.   "
111920|NCT01820975|"     In the present study, the effect of habitual dietary protein on the anabolic response will be     investigated.   "
111921|NCT01820962|"     Patients with a hematological malignancy who are undergoing intensive chemotherapy need a     central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they     are not used.      The purpose of this study is to determine whether concentrated citrate locking, compared to     heparin, reduces the incidence of central venous catheter-related thrombosis and infections     in patients with hematological malignancies undergoing intensive chemotherapy.   "
111922|NCT01820949|"     This study will evaluate clinical outcome after the step-wise implementation of a Patient     Blood Management (PBM) Program in surgical patients at 4 hospitals.   "
111923|NCT01820936|"     The purpose of this study is to compare the effect of food and two modified fasting regimens     on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult     participants.   "
111924|NCT01820923|"     The aim of this study is to determine whether transcranial brain stimulations, such as     repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current     stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients     in vegetative and minimally conscious state.   "
111925|NCT01820910|"     Objective of this trial is to establish the efficacy of an upfront targeted therapy     consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration     of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection     re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma The     primary endpoint is the 2-year progression-free survival (PFS) of patients with newly     diagnosed stage-IE lymphoma treated with the experimental strategy.   "
111926|NCT01820897|"     Urinary tract infections (UTI) are the most common complications after kidney     transplantation. Most series have reported incidence between 20 to 50% during the first year.     In the most recent report from our center the incidence was 36.6% during the first 6 months     after transplantation.      The clinical consequence in the graft survival and the association with immunological     rejection has not been well defined. Nevertheless, the association of UTI with high rate of     hospitalization and their costs are widely recognized. There is paucity of trials, specially     randomized and controlled, comparing antibiotic prophylaxis in this group of patients. In a     recently published metaanalysis Green et al. (Transpl Infect Dis. 2011 Oct;13(5):441-7) found     only 6 clinical trials well designed, the conclusion was that antibiotic prophylaxis reduced     the incidence of UTI and the risk of sepsis. Based in this information, the KDIGO guidelines     in transplantation recommend the prophylaxis for UTI with sulfamethoxazole-trimethoprim     (SMT). Nevertheless, the rate of bacterial resistance to SMT has been reported above 50% in     almost all the series.      Fosfomycin-trometamol (FT) is a wall antibiotic (piruvil-tranferase inhibitor) that has shown     a good bioavailability, especially in the urinary tract. It has shown a wide antibacterial     spectrum, but the important target seems to be enteric bacilli particularly Escherichia coli     (the most prevalent cause of UTI). FT has also shown a very good activity against E. coli     producer of Extended Spectrum Betalactamases. Recently, the rate of these multi-drug     resistant bacteria has increased in our center as evidence of worldwide distribution. In     addition, the rate of FT resistance has been stable during the last years (<3%). This     phenomenon could be explained because of the properties of this antibiotic, the most     important one seems to be related with the unique mechanism of action and the lack to     propagate the mechanisms of resistance at least in E. coli. There is only one clinical trial     (randomized and controlled), which compared FT with placebo in UTI prophylaxis; 317 women     with recurrent UTI (three by year) were included. They found rates of 0.14 and 2.9     episodes/patient/year, respectively (p<0.001). Furthermore, there was no FT resistance during     the follow up.      Our hypothesis is that in the first six months after kidney transplantation, UTI prophylaxis     with FT will show greater efficacy in comparison with SMT. Considering the incidence of UTI     in our center (36.6%) and the rate of UTI in the unique trial of prophylaxis with FT (14%),     65 patients will be needed by group of treatment to demonstrate a difference of 22% in the     incidence of UTI, with a power of 80% and confidence level of 95%. The primary outcome is the     incidence and rate of UTI during the first six months after kidney transplantation. The     secondary outcomes are, the hospitalization rate, antibiotic resistance rate, rejections and     titer and number of de novo donor specific antibodies.      The investigators propose a randomized, double blind, placebo controlled trial to compare FT     with SMT in the efficacy and safety to prevent UTI during the first six months after kidney     transplantation. The investigators will include patients from two tertiary-care transplant     centers. Recruiting and the randomization will be carried out separately by center and gender     (because female patients have a greater risk of UTI). The medical visits will be scheduled     monthly and include general laboratory, urine culture and information gathering about     antibiotic side effects as well as adherence. Rejection rate and the number and titers of de     novo donor specific antibodies (secondary outcome) will be obtained according to the standard     of care of the institutional kidney transplantation follow up. These include kidney biopsy at     days 0 and 90 after transplantation, as well as determination of donor specific antibodies     after sixth months of follow up. Graft biopsy is also performed whenever graft dysfunction     exists in the absence of an identifiable cause (infection, urinary graft obstruction).   "
111927|NCT01820884|"     This randomized trial is studying the efficacy and safety of the hysterectomy alone compared     with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA     endometrial carcinoma.   "
111943|NCT01820663|"     This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor     impairment after stroke. It is based on the hypothesis that after stroke, the brain's     utilization of glucose, it's primary source of energy, is disrupted. The MAD is a     low-carbohydrate diet that has can switch the body's metabolism from using glucose to using     products of fat metabolism, so-called ketones. Ketones may act as an alternative energy     substrate for the brain. Ketones also have several neuroprotective effects after stroke.   "
111928|NCT01820871|"     The purpose of this study is to evaluate the effectiveness of smartphone application for     management of type 2 diabetes mellitus (DM).      Type 2 DM is an almost incurable chronic disease and continuous management is important for     long-term prognosis. However, patient's compliance to conventional medical intervention is     generally unsatisfactory and many patients feel difficult to access to the detail medical     advice for type 2 DM.      Thus, the investigators developed a smartphone application for giving programed medical     intervention to patients according to patients data; blood pressure, fasting blood sugar,     body weight, calorie intake,exercise amount, etc.   "
111929|NCT01820858|"     This randomized trial is studying the efficacy and safety of the chemotherapy compared with     radiation therapy alone as adjuvant treatment after operation in Patients with high risk and     Stage I endometrial carcinoma.   "
111930|NCT01820845|"     Plethysmographic Variability index is a simple index accurate in predicting fluid     responsiveness.      The aim of this study was to investigate its accuracy in predicting fluid response to     intravenous fluid challenge during scoliosis surgery in children.   "
111931|NCT01820832|"     The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.   "
111932|NCT01820819|"     The purpose of this study is to determine whether there are reasons other than medical     reasons that could limit access to liver transplantation in alcoholic patients.   "
111933|NCT01820806|"     This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg     [14C]-radiolabeled GLPG0634.      The study aims to establish the elimination pathways of GLPG0634 and their relative     significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.      Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634     will be evaluated.      This study will also provide safety and tolerability information for GLPG0634.   "
111970|NCT01820312|"     The purpose of this study is to determine if low-dose radiation therapy and the chemotherapy     drug paclitaxel is effective in treating head and neck cancer that has returned after     treatment with standard radiation therapy alone, but cannot be removed by surgery. The     overall total dose received of both the chemotherapy and radiation therapy will be less than     that typically given as standard of care; however, the Food and Drug Administration (FDA) has     not evaluated the safety and effectiveness of this combination therapy. In addition, this     study will gather information about the effects of radiation therapy and chemotherapy on     subject's overall quality of life.   "
111934|NCT01820793|"     Escherichia coli is the primary cause of urinary tract infections and Gram-negative     bacteremia worldwide. Since the early years of the 21st century, E.coli has acquired a new     mechanism of resistance to antibiotics: extended spectrum β-lactamase (ESBL), type CTX-M.     These ESBL inactivate most β-lactams, the preferred class of antibiotics for the treatment of     severe E.coli infections. Moreover, the strains that produce these ESBL are often resistant     to other classes of antibiotics. Their rapid spread constitutes a major public health concern     because of a serious risk of therapeutic impasse. Treatment options in cases of infection     with ESBL-producing E.coli are often limited to carbapenems, a class of more recently     developed β-lactams. Carbapenems have a very wide spectrum of activity but their     effectiveness is threatened by the emergence of strains producing carbapenemases. The     development of therapeutic alternatives to treat ESBL-producing E.coli infections is     therefore essential. Cephamycins, including cefoxitin, are β-lactams marketed in the     seventies but their use was practically abandoned when wide spectrum antibiotics became     available. They are distinguished by the presence of an α-methoxy group in position 7 which     interferes with the action of the extended-spectrum β-lactamase and renders it ineffective     against cephamycins. Cefoxitin is therefore active in vitro against ESBL-producing E.coli and     offers the advantage of a narrower antibacterial spectrum, thus reducing the selection     pressure and the emergence of resistance. However, the in vivo activity of cefoxitin for the     treatment of ESBL-producing E.coli infections has never been measured. Furthermore, available     pharmacokinetic and pharmacodynamic (PK/PD) data for cefoxitin are dated and incomplete,     which raises many questions concerning the optimal dosage regimen. We have shown in a mouse     model of ESBL-producing E. coli CTX-M pyelonephritis that cefoxitin efficacy is comparable to     that of carbapenems without selecting resistant mutants. Cefoxitin could thus constitute an     alternative to carbapenems for the treatment of pyelonephritis caused by ESBL-producing     E.coli.   "
111935|NCT01820780|"     After decompensated heart failure, a number of patients have high risk of early     rehospitalization as well as death. Specialized medical management for a short period but     very early after discharge could be critical for optimizing care and improving early outcome.      This study aims to compare such early intensive medical management with usual care in     high-risk patients after discharge.   "
111936|NCT01820767|"     Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of     inflammatory and oxidative stress parameters.   "
111937|NCT01820754|"     The purpose of this study is to evaluate whether the combination of neoadjuvant chemotherapy     (chemotherapy before surgery) plus ipilimumab for lung cancer increases the number of     patients with detectable circulating T cells with specificities against tumor associated     antigens (TAA) from zero percent (0%) of patients prior to therapy to 20% of patients after     neoadjuvant chemotherapy plus ipilimumab.      This is an open label Phase 2 trial. Patients with clinical stage IB (>4 cm), II, (N0-2)     non-small cell lung cancer (NSCLC) and no prior therapy for the current diagnosis of lung     cancer will be eligible for the study. Subjects will receive 3 cycles of neoadjuvant     chemotherapy (paclitaxel + cisplatin/carboplatin). Ipilimumab will be administered during     Cycles 2 and 3 of standard chemotherapy and for up to 4 cycles alone after surgery. Subjects     will undergo standard clinically indicated surgical resection of their lung cancer as deemed     appropriate by their surgeon.      Standard diagnostic and staging work up will be performed including: pathologic/histologic     diagnosis of NSCLC, Positron Emission Tomography (PET)/Computed Tomography (CT) scan, brain     imaging, and mediastinoscopy. Three cycles of neoadjuvant chemotherapy will be given.     Ipilimumab will be added to neoadjuvant chemotherapy for cycles 2 and 3. Standard surgical     evaluation and therapy will be performed following completion of neoadjuvant therapy. Two     cycles of single agent ipilimumab will be given after surgery (adjuvantly), followed by 2     cycles of maintenance therapy.   "
111938|NCT01820728|"     This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in     treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene     citrate treatment. The study is conducted with following methods: open label,     active-controlled, randomized, parallel group, comparative.   "
111939|NCT01820715|"     A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is     designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for     Neuropathic pain.   "
111940|NCT01820702|"     Randomized cross-over design with 10 male subjects and 3 campaigns to test whether the     negative effects of bed rest (6º head-down tilt) on the various systems of the body and the     consequences to health of simulated weightlessness can be counteracted by the use of a     defined training programme.   "
111941|NCT01820689|"     Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the     post surgery period and correlate it with the time of palatoplasty. Methods: The sample     consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public     University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three     months to 33 years. Were sampled patients of both sexes, pediatrics and adults.   "
111942|NCT01820676|"     This study is designed to monitor long term clinical outcomes of the iUni G2+     unicompartmental knee replacement   "
111955|NCT01820507|"     Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main     reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of     breathing. Most of this issues can be partly counterbalanced by a device named High flow     conditioned oxygen therapy (HFCO). Then, our hypothesis is that HFCO may reduce the     incidence of respiratory failure after extubation in patients with high risk for failure.   "
111956|NCT01820494|"     The study objective is to assess the growth of infants fed an experimental formula for the     nutritional management of chronic diarrhea.   "
111957|NCT01820481|"     This clinical trial is designed to evaluate the efficacy, dose-response and safety of     WIN-901X in Asthma patients.   "
111958|NCT01820468|"     This randomized controlled study tests an adapted critical time intervention model for     veterans discharged from a psychiatric inpatient unit. It is hypothesized that veterans on     the inpatient unit who are assigned to such a community-based team will have shorter lengths     of inpatient stay and better mental health. There have been few developments of     community-based models of care in the post-deinstitutionalization era of short inpatient     stays and the results of the study may inform how inpatient stays can be further reduced.   "
111971|NCT01820299|"     This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate,     lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify     plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation     throughout the entire body) in subjects with advanced cancer.   "
112215|NCT01817127|"     This observational study is designed to determine how sugars, lipids and proteins in breast     milk vary among mothers; is affected by maternal diet, health and microbiota and vary over     the course of lactation. Additionally, the study is designed to determine how the structure     and composition of complex milk sugars, maternal health status and diet influence the     development and maintenance of infant gut microflora.   "
111959|NCT01820455|"     All trauma patients admitted to certain Intensive Care Units (ICU) will have     Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA     colonization status. Only those patients who are determined to be colonized with MRSA at     admission will be included in the study. All patients must be age 18 and older, admitted     directly to the ICU from either the Emergency Department or the operating room with     trauma-related injuries, and must not have active or recent known history of MRSA infections.     Once patients have been determined to be colonized with MRSA, they will be randomized to     receive decolonization treatment or placebo. Decolonization treatment will include     Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail     routine soap baths and Lubricating Jelly. Both groups will be kept on standard contact     precautions throughout the course of the study. Repeat nasal swabs will be performed at the     completion of the treatment regimen to determine the efficacy. Patients will be screened for     invasive MRSA infections as dictated by their clinical course. The primary outcome measure     will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft     tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay,     mechanical ventilatory support requirements, colonization status at the end of treatment, and     death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm     over the course of 12-24 months.   "
111960|NCT01820442|"     The primary objective of this study is to assess lofexidine related effects on QTc (an     interval of the heart rhythm) in subjects receiving buprenorphine maintenance. The secondary     objectives of the study are to evaluate the safety and tolerability of lofexidine by     evaluating and monitoring pharmacokinetics (amounts of drug in the blood), vital signs (heart     rate and blood pressure) and adverse events (side effects) when co-administered with     buprenorphine; to describe effects on opiate withdrawal when lofexidine is introduced     following a 50% buprenorphine dose reduction, as required to elicit a withdrawal response;     and to evaluate QTc interaction effects of lofexidine compared with placebo. The     Investigators hypothesize that while lofexidine is known to prolong the QTc interval, the     combination of the drugs will not create an additive effect which creates a significant     safety concern. The Investigators further hypothesize that subjects will be able to tolerate     the therapeutic dose of lofexidine (0.8 mg four times daily) when the buprenorphine     maintenance dose is lowered to elicit withdrawal.   "
111961|NCT01820429|"     The purpose of this study is to compare the response to aspirin in the acute phase with the     late phase of an acute coronary syndrome.   "
111962|NCT01820416|"     The purpose of this study is to determine whether low-level laser therapy can improve hearing     thresholds in individuals with hearing loss. Subjects will be randomly assigned to a     treatment, placebo, or control group. The treatment group will be given a three treatment of     low-level laser therapy, which consists of shining low-level lasers beams onto the ear and     head. The laser beams are cool to the touch, and do not cause discomfort. Each laser     treatment will last approximately 4 minutes. Three treatments will be applied three times     within the course of one week. Hearing tests will be administered immediately before     treatment, immediately after treatment, and six weeks after treatment. Results will be     analyzed to determine the effect of the laser treatment on hearing.   "
111963|NCT01820403|"     The study purpose was to evaluate the effects of portion sizes on body weight and energy     intake in a free-living setting. 223 healthy adults were recruited from an urban worksite and     randomized to one of four groups for a six-month period. The groups were: 1) 400 kcal box     lunch; 2) 800 kcal box lunch; 3) 1600 kcal box lunch; or 4) no box lunch. Participants were     required to pick up a box lunch every week day for six months. Control participants did not     receive a box lunch and were instructed to eat their usual lunch. Participants were weighed     and dietary intake measured at baseline, one, three and six months. It was hypothesized that     at six months, participants in the 1600 kcal box lunch would gain more weight and have higher     energy intake than those in the other groups.   "
111964|NCT01820390|"     Deep brain stimulation (DBS) has become the primary surgical therapy for the treatment of     motor symptoms associated with Parkinson's disease (PD), and for essential tremor (ET).     Although an effective and relatively safe procedure with expanding indications, opportunities     exist for the optimization of the current procedure.      The investigators therefore propose, in a group of patients undergoing DBS surgery for the     treatment of PD or ET, to use a combination of high‐field imaging modalities, intraoperative     electrophysiology, external sensor interfaces, and computational modeling, to gather     information on the utility of using these techniques to optimize DBS electrode placement and     programming.   "
111965|NCT01820377|"     Building on the successes of a communal, relationship based approach to Aboriginal youth     mentoring in an after school physical activity program (AYMP), the investigators are     evaluating a peer-led approach for diabetes prevention.   "
111966|NCT01820364|"     The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity     of LGX818 in combination with selected agents.   "
111967|NCT01820351|"     The purpose of this study is to establish, through ultrasound, measurements of the thigh     muscles (Biceps Femoris and Vastus Lateralis)and the chronic effects of a static stretching     program on the muscle-tendon unit these muscles.   "
111968|NCT01820338|"     The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) trial will evaluate the     impact of a community based intervention delivered to families in rural settings utilizing     the existing Cooperative Extension Service network on child dietary intake and weight.     Specifically, the E-FLIP for Kids study will determine if behavioral treatments for child     obesity lead to greater improvement in child weight compared to educational only     treatment.Participants will include 240 parent-child dyads from ten rural counties in north     central Florida. Study outcomes will be measure prior to treatment, at the end of treatment     (month 12) and at one year follow-up (month 24). All treatment meetings will be held at     Cooperative Extension Service offices within each participating county.   "
111969|NCT01820325|"     The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended     Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week     carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC.      The purpose of the Phase II portion of the study was to assess the treatment effect of adding     buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel     on progression free survival (PFS) in patients with previously untreated metastatic squamous     NSCLC.   "
111972|NCT01820286|"     The investigators are doing this study to see if positive psychology can help adults with     depression or bipolar disorder.      Positive psychology involves exercises—short tasks—that try to increase good feelings and     emotions, like optimism, happiness, personal strengths, and well-being. Positive psychology     exercises might include imagining a bright future, being grateful for good events, forgiving     others, and doing kind acts for others.      The investigators want to see if practicing positive psychology exercises after leaving the     hospital can increase feelings of hope, optimism, and positive thinking. The investigators     are asking you to take part in this research study because you are in the hospital for     depression or bipolar disorder.      This research study will compare positive psychology exercises to control condition     exercises. During the study, you may take part in control condition exercises instead of     positive psychology exercises.   "
111973|NCT01820273|"     The purpose of this study is to determine the early changes in gut hormonal, and other     metabolites with known relations to the glycemic homeostasis. The study mainly focus on these     responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass     surgery. Also aiming for recording changes in the earliest postoperative phase.   "
111974|NCT01820260|"     To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily     treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in     different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle     gel   "
111975|NCT01820247|"     The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with     enteral nutrition in the treatment of Crohn's disease for induction remission and compare the     therapeutic effect with patients who only received Tripterygium Glycosides or enteral     nutrition.   "
111976|NCT01820234|"     The purpose of this study is to determine the diagnostic and management concordance of     face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer     screening event.      The investigators' hypotheses include the following:        1. Compared to in-person assessment, store-and-forward teledermatology assessment will          result in adequate diagnostic concordance.        2. Compared to in-person assessment, store-and-forward teledermatology results in adequate          management concordance.        3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions          that are either premalignant or malignant will be similar to that of in-person          evaluation.   "
111977|NCT01820221|"     This is a randomized prospective clinical trial designed to determine the wound complication     rates for stainless steel staples versus subcuticular suture for skin closure in the obese     parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.   "
111978|NCT01820208|"     After successful screening, first the investigators first treat patients of severe alcoholic     hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's     score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to     steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non     responders will be randomized to receive G-CSF for 28days.   "
111979|NCT01820195|"     There are many controversies about the role of N-Acetyl Cystein in preventing of contrast     nephropathy. These contradictory results may be due to different criteria for patients'     selection, different end points, different type and dose of N-Acetyl Cystein administration     and finally different prophylactic measures other than N-Acetyl Cystein. The investigators     try to enroll a double blind double dummy study with a good power to compare the effect of     this drug both in the form of oral and intravenous against the placebo in preventing the     contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.   "
111980|NCT01820182|"     Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2     to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging,     Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices     are administered is randomly allocated.   "
111981|NCT01820169|"     This clinical study is to determine if the use of structured testing, which is a blood     glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive     effect on the subjects overall glycemic control.   "
111982|NCT01820156|"     Study Objectives: Obstructive sleep apnea (OSA) diagnosis using simplified methods such as     home respiratory polygraphy (HRP) is only recommended in patients with a high pre-test     probability. The aim is to determine the diagnostic efficacy, therapeutic decision-making and     costs of OSA diagnosis using PSG or three consecutive studies of HRP in patients with     mild-moderate suspicion of sleep apnea or with co-morbidity that can mask OSA symptoms.      Design and Setting: Randomized, blinded, crossover study of three nights of HRP (3N-HRP) vs.     PSG. The diagnostic efficacy was evaluated with ROC curves. Therapeutic decisions to assess     concordance between the two different approaches were analyzed by sleep physicians and     respiratory physicians (staff and residents) using agreement level and kappa coefficient. The     costs of each diagnostic strategy were considered.   "
111983|NCT01820143|"     The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and     compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1)     and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg     ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg,     20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days;     and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following     QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets     for 5 consecutive days.   "
111984|NCT01820130|"     The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal     Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter     Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).   "
112019|NCT01819675|"     The purpose of this study is to determine whether repetitive transcranial magnetic     stimulation (rTMS) over the brain can modulate the binding of neurotransmitter (GABA in this     study) to its receptor using the special PET study.   "
112283|NCT01816243|"     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so     the drug will enter the body through the skin) in Thai participants with chronic (lasting a     long time) non-malignant (non-cancerous) pain.   "
111985|NCT01820117|"     While thoracic radiation therapy (TRT) has been a primary component in successful treatment     of a variety of childhood and adult cancers, the exposure to this treatment has been     associated with significant cardiovascular and pulmonary morbidity in long-term survivors.     Within non-cancer populations, cardiovascular and pulmonary morbidity is associated with     increased risk for cerebral vascular accidents (CVAs), accelerated brain atrophy and     neurocognitive impairment. Patients with chronic heart disease demonstrate problems with     attention, processing speed, memory, and executive functions. Chronic pulmonary disease also     increases the risk of stroke, leukoencephalopathy, and neurocognitive impairment in     non-cancer populations. The investigators propose to examine indices of brain integrity,     including neurocognitive performance and brain MRI/MRA, in long-term adult survivors of     Hodgkin lymphoma (HL) treated with thoracic radiation and no direct central nervous system     therapy.      OBJECTIVES:        1. To evaluate brain integrity in adult survivors of childhood HL treated with thoracic          radiation therapy.        2. To identify therapeutic factors associated with brain integrity in adult survivors of          childhood HL who are at risk for cardiac and pulmonary morbidity.        3. To examine associations between cardiac, vascular and pulmonary health and brain          integrity in adult survivors of childhood HL treated with thoracic radiation.   "
111986|NCT01820104|"     Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump     inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the     hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this     therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole,     DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation     in healthy subjects in oral glucose tolerance (OGTT).   "
111987|NCT01820091|"     To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related     Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.   "
111988|NCT01820078|"     The purpose of this study is to estimate the differences between albuminuria values     determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last     observation caused by paricalcitol between the group of control and group of treatment.   "
111989|NCT01820065|"     Although contemporary cataract surgery has made tremendous strides in technological     advancement, posterior capsular opacification (PCO) is still the most frequent long-term     complication leading to decreased visual functions and thereby dissatisfying results. A great     deal of effort has been made to develop new ways to prevent the formation of PCO. A key     factor, widely discussed in literature, is the material and design of the intraocular lense     (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL     produces less PCO because of its optic geometry alone or whether the biomaterial contributes     to the inhibition of PCO. With the clinical introduction of the single‐piece acrylic     hydrophobic IOLs with some optic and haptic design differences compared with three‐piece     acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material     and design on PCO prevention. It is well established that the development of PCO is a dynamic     process and that a longer follow-up time is correlated with a higher degree of PCO. So far,     there have been prospective clinical studies on the clinical results of single and     three‐piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the     PCO further increases or becomes stable or regresses on a long-term basis has not yet been     answered. Since there is paucity of available literature that prospectively evaluates the     development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL     on a long-term basis, the investigators decided to observe the degree of development of PCO     at 5 years after cataract surgery.   "
111990|NCT01820052|"     Fibromyalgia (FM) is a disorder with chronic widespread musculoskeletal pain for which no     alternative cause can be identified. The condition is often accompanied by other features     such as fatigue, stiffness, cold intolerance, cognitive impairment, intolerance to external     stimuli, sleep disturbances, anxiety and depression, which significantly affect the quality     of life. Fibromyalgia is characterized by altered pain perception, and studies have shown     fibromyalgia to be more prevalent in patients with iron deficiency anemia. Iron is essential     for a number of enzymes involved in serotonin and dopamine synthesis. Deficiency of     serotonergic neuronal functioning might be related to the pathophysiology of FM.      This study attempts to explore the use of oral iron as a cheap and readily available     alternative for the treatment of FM .   "
112041|NCT01819389|"     The purpose of this study is to determine if low-dose imatinib and nilotinib combination,     will improve treatment results in CML patients with failure, suboptimal response or     intolerance to imatinib therapy.      The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular     response will be achieved in patients not previously obtained with imatinib monotherapy.   "
111991|NCT01820039|"     Objectives The investigators present an online application to empower and inform patients and     improve guideline adherence in unexplained subfertility. Thereby the investigators expect to     reduce overtreatment in fertility care with higher quality of care.      Methods The investigators conduct a prospective cohort study including couples with a     diagnosis of unexplained subfertility. Couples consulting their general practitioner with an     unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online     application, in which patients are asked questions about their fertility problem (ie     menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis     antibody titre and semen analysis). FertiScreen then uses the validated prediction model of     Hunault to calculate couples' chance of natural conception during the next twelve months. In     addition, patients can find links to extra information concerning subfertility. Couples can     then initiate an online consultation with their general practitioner and a gynaecologist, in     order to discuss their results and prognosis. When the calculated prognosis of spontaneous     conception within one year is >30%, tailored expectant management for 6-12 months will be     advised, as no benefit can be expected from fertility treatment.      Questionnaires will be sent to patients as well as to their caregivers (general practitioner,     gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability     Scale) and the different domains of quality of care (effectiveness, cost-effectiveness,     safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and     Depression Scale and the Patient Centredness Questionnaire for Infertility.      In order to be able to draw conclusions, the investigators will conduct a baseline     measurement among couples with unexplained subfertility who have been referred to a fertility     clinic. Their data will be abstracted from their medical records and they will receive the     aforementioned questionnaires as well (except for the System Usability Scale).      The investigators will recruit couples presenting to general practitioners in the Nijmegen     area (which for second line treatment consists of one general hospital and one academic     hospital). To detect an increase in guideline adherence of the current 60% to 75% with a     power of 80% (P<0,05), the investigators need to include 152 couples in the before as well as     in the after measurement.   "
112060|NCT01819142|"     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a     prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will     be treated using AutoloGel and standard care and case-matched against a concurrent cohort of     patients receiving undefined Usual and Customary Care.   "
111992|NCT01820026|"     Bacterial infections are a frequent complication in liver cirrhosis with a bad prognosis.     However, the clinical outcome of cirrhotic patients with serious infections is significantly     improved over the last 30 years due to early diagnosis and to the use of a more appropriate     antibiotic therapy.      As in the general population, empirical treatment should be initiated soon after diagnosis,     after making the necessary sampling and should be based on the use of an antibiotic with low     toxicity and broad spectrum antibacterial efficacy, taking into account the local     epidemiology and prevalence of antibiotic resistance.      The third generation cephalosporins are considered the gold standard in the treatment of most     infections in cirrhotics due to their effectiveness against enterobacteriaceae and against     non-enterococcal streptococci and due to their low toxicity.      However, the recommendations for the antibiotic therapy are currently based on results of     trials of '80s and '90s, when the proportion of resistant pathogens was lower. Similarly to     nosocomial infections, the increasing rate of infections due to multidrug resistant (MDR)     bacteria represents the rational for a different choice of empirical antibiotic therapy with     a higher resistance barrier. This change in the epidemiology of community acquired infections     is mainly due to the increased contacts with healthcare system of these patients and for the     larger use of antibiotic prophylaxis. With this regard, it was recently proposed to introduce     a third epidemiological class of infection Health care-associated: Infections occurring in     community in patients who have been in contact with the health system shortly before the     infection.      This epidemiological class of infection should be distinguished from community-acquired     because they are more similar tonosocomial in terms of their sensitivity to antibiotics.     Therefore for this class should be taken into consideration the use of a different empirical     antibiotic therapy.      The investigators aim was to evaluate prospectively the effectiveness of a broad spectrum     antibiotic treatment in a cohort of cirrhotic patients with healthcare-Associatedinfections      Cirrhotic patients with Healthcare Associated admitted to the gastroenterology department     of the Policlinico Umberto I and in the Department of Hepatology of the Hospital of Marino     will be consecutively enrolled.      Randomized controlled trial with randomisation stratified by epidemiological class of     infection.   "
111993|NCT01820013|"     This blinded randomized comparative trial aims to determine the effectiveness of a customized     Dynamic Elastomeric Fabric Orthoses (DEFO) compared to a standard pelvic belt in: a) reducing     pregnancy-related pelvic girdle pain (PGP), b) optimizing activity levels in pregnant women     with PGP, c) improving quality of life for pregnant women with PGP d) cost effectiveness.   "
111994|NCT01820000|"     Use of MRI and DWI to diagnose cardiac scarring after heart attack.   "
111995|NCT01819987|"     About 17% of Chinese American preschool children are obese, compared to 12.4%of all children     from age three to five years residing in the US; the prevalence of obesity is expected to     increase in the future. Therefore, the proposed study will adapt a home-based and     technology-centered childhood obesity prevention program for low-income Chinese American     mothers of children three to five years old. The aims of the study are to assess the     feasibility of the intervention and estimate the effect sizes on children's and mothers'     outcomes.   "
111996|NCT01819974|"     The purpose of the study is to examine whether a stratified medication review performed in     patients at highest risk of experiencing medication errors have impact on numbers of     medication errrors during hospitalization.   "
111997|NCT01819961|"     The aim of this study is to assess the effect of postoperative parenteral fish oil on     clinical outcome and immune function after major laparoscopic abdominal surgery.   "
111998|NCT01819948|"     The purpose of this study is to determine whether the administration of the PhytoMed™     complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer     which has been completely surgically resected and without evidence of disease as determined     by their physician   "
111999|NCT01819935|"     The purpose of this non-interventional, retrospective study of existing data is to evaluate     clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based     pneumonia by treatment and among subpopulations.   "
112000|NCT01819922|"     This study is designed to assess the effect of one single dose of PF-05175157 on metabolic     and cardiopulmonary parameters before, during and after treadmill exercise in healthy     volunteers.   "
112001|NCT01819909|"     There are very few level 1 or level 2 evidence studies that examine postoperative     rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level     1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that     found only four studies that examined rotator cuff repair rehabilitation.      The current study was performed to determine if there is a significant difference in passive     glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular     substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo     rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins'     exercises.      Null Hypothesis: There will be no significant difference in passive range of motion, active     range of motion, scapular substitution, and subject measured outcomes scores in subjects who     undergo rotator cuff repair when treated with pulley exercises compared to Jackins'     exercises.   "
112002|NCT01819896|"     Over the past year smartphones have developed from a niche product to a commoditized product     and are now squeezing classic mobile phones out of market. According to a survey a quarter of     the German population is making use of a smartphone at present.      An interference between smartphones and the functionality of pacemakers or implantable     defibrillators is rather unlikely but cannot entirely be excluded. A systematic study     regarding a possible interference between smartphones and modern pacemaker- and ICD-system     with a better shielding against external influence has not taken place so far. In this study     the investigators intend to investigate any interference between different smartphones     produced by different manufacturers and diverse cardiovascular implanted electronic devices.   "
112005|NCT01819857|"     For many years droperidol has been used in prophylaxis and therapy of PONV. Information that     it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those     data didn't base on solid examinations confirming torsadogenic action of droperidol. It is     known that droperidol prolongs time of repolarisation, but there wasn't any data confirming     its impact on transmural dispersion of repolarisation. Only estimation both of those actions     in one time allows to define for sure arrhythmogenic role of droperidol.      The aim of this study was to answer the questions:      6. Does droperidol make an significant prolongation of heart repolarisation, expressed as     corrected QT interval?        1. Does droperidol cause increase of transmural dispersion of repolarisation?        2. Does possible torsadogenic acting of droperidol depend on dose of drug?        3. Does ondansetron cause changes of electrical heart function, suggesting its          possibilities to induce TdP tachycardia?        4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in          people not suffering from cardiovascular diseases?   "
112006|NCT01819844|"     The purpose of this study is to test an experimental medical device designed to automatically     control blood sugar. This device was designed for use by patients with diabetes while they     are in the hospital, and others who may develop high blood sugar as a result of their medical     problems.   "
112007|NCT01819831|"     When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back.     Radiation therapy is frequently used in addition to surgery to reduce the chances of the     sarcoma coming back. However, radiation can have long-term side effects on the normal tissues     surrounding the tumor, leading to problems such as swelling, scarring, and joint stiffness.      Recently, there have been advances in the way that radiation therapy can be given. Proton     radiation therapy is one of those advances. With proton radiation, it is possible to give     radiation over a smaller area surrounding the tumor, resulting in less radiation to the     surrounding normal tissues.      The purpose of this study is to determine whether proton radiation decreases the long-term     side effects of radiation on normal tissues and if smaller proton radiation fields reduce     local recurrence compared to the larger radiation fields that have been used in prior     studies.   "
112008|NCT01819818|"     The purpose of this study is to evaluate the safety and tolerability of paliperidone     palmitate over a 9-week period for participants with schizophrenia in Korea.   "
112009|NCT01819805|"     The purpose of this study is to evaluate the impact of extended release tramadol     hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.   "
112010|NCT01819792|"     Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia)     induction and consolidation chemotherapies related aplasia. The main aim of this study is to     measure incidence of respiratory viral infections during AML induction and consolidation     chemotherapy related aplasia. Primary end point is a positive polymerase chain     reaction(PCR)associated with clinical signs.   "
112011|NCT01819779|"     The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and     S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination     formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a     combination formulation of valsartan and S-amlodipine as test drug in healthy male adults.     Additionally the safety and tolerability of two drugs will be evaluated.   "
112012|NCT01819766|"     This study aims to determine the performance of the Exact IBD-ACRN surveillance test to     detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel     disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of     primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to     participate in this study. Enrolled subjects will collect a stool sample for the Exact     IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days     prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of     enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.   "
112013|NCT01819753|"     In this study 37 patients who had undergone percutaneous nephrolithotomy were included.     Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans     were randomized by evaluating them before (n=25) and after (n=12) the 6th postoperative     month. A DMSA scan was read by using a technique that divides both kidneys into three paired     poles. In this way functional changes were investigated in the renal units. Twenty six of 37     cases underwent percutaneous nephrolithotomy with a single access site and 11 with multiple     access sites. When each of the poles of a kidney was admitted as a surgical unit separately,     there were 51 units.   "
112014|NCT01819740|"     The aim of our study is to determine if the levels of the HEM substance in seminal plasma     are associated with the presence of prostate cancer in transrectal prostate biopsy.   "
112015|NCT01819727|"     The BMN 165 clinical development program has been designed to demonstrate the safety and     efficacy of BMN 165 in reducing blood Phe concentrations in patients 18 to 70 years old with     hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label, randomized     study designed to further characterize the safety of BMN 165 during two induction, titration,     and maintenance dose regimens in adults with PKU who have not had previous exposure to BMN     165 (naive). Subjects will be randomized (1:1) to titrate up to one of two dose regimens.     Other key features of this study are the dose regimens chosen for induction and titration;     the study duration; self administration of study drug; and the chosen tertiary objectives.   "
112016|NCT01819714|"     The main objective of this study is to evaluate the effect of 3 months of Snoezelen-type     multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for     patients with Alzheimer's-type neurodegenerative disease.   "
112042|NCT01819376|"     The purpose of this study is to determine if Facebook can be used as a motivating factor for     obese or overweight adolescents in a weight-reduction program.   "
112043|NCT01819363|"     The objective of this study is to analyze the correlation between pleural elastance and the     radiological effectiveness (measured by chest tomography) of pleurodesis performed via     catheters in patients with RMPE. The secondary objectives of this study are: correlate     pleural elastance with quality of life, analysis of dyspnea and pain after the procedure,     clinical effectiveness, complications and mortality in 30 days.   "
112044|NCT01819350|"     The aims of this study were to determine the sucrose and liquid oral pediatric medicines of     long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.   "
112017|NCT01819701|"     Cardiovascular disease (CVD) is the leading cause of Taiwan. L-carnitine (LC) and coenzyme     Q10 is recognized as lipid soluble antioxidants. The purposes of this study are going to     investigate the relation of LC and coenzyme Q10 with the markers of lipid peroxidation,     antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD)     patients. The study is designed as a three-year study. The first year is an observation     study. We will recruit CAD patients who are identified by cardiac catheterization as having     at least 50% stenosis of one major coronary artery, and age-gender matched healthy subjects.     The concentrations of LC, coenzyme Q10, lipid peroxidation markers (TBARS and ox-LDL),     antioxidant enzymes activities (catalase, glutathione peroxidase, glutathione reductase, and     superoxide dismutase), and inflammatory markers are going to analysis. The second year is a     single-blind, single dose intervention study. CAD subjects are recruit form the first year     and randomly assigned to placebo, coenzyme Q10-150 (150 mg/d), coenzyme Q10-300 (300 mg/d),     LC-1000 (1000 mg/d) or LC-2000 (2000 mg/d) groups. Intervention is going to administration     for three months. Fasting blood will be obtained in each month and determine the     concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes     activities, and inflammatory markers after intervention. The third year is a single-blind,     multiple doses intervention study. We are going to measure the CAD subjects from the second     year intervention study. After three months washout period, the subjects are assigned to     placebo, coenzyme Q10-150 plus LC-1000, coenzyme Q10-150 plus LC-2000, coenzyme Q10-300 plus     LC-1000, and coenzyme Q10-300 plus LC-2000 groups. Intervention is going to administration     for three months. Fasting blood will be obtained in each month and determine the     concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes     activities, and inflammatory markers after intervention. Hopefully, the results of this study     could provide information of LC and coenzyme Q10 supplementation for clinical dietitian in     advising CAD patients.   "
112018|NCT01819688|"     The purpose of this study is to determine whether the postoperative insulin resistance and     cytokine release would be attenuated in laparoscopic compared with open liver resection.   "
146174|NCT01370993|"     The purpose of this study is to develop the hypoxemia prediction model during fiberoptic     bronchoscopy under MAC(monitored anesthesia care) anesthesia.   "
112020|NCT01819662|"     Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people     have a pacemaker, and each year another 36,000 receive them. All of these patients are     usually seen yearly to have their device checked. However, pacemaker technology is now very     reliable, batteries last well over 5 years, and many patients require their pacemaker only     occasionally as a back-up. Each visit costs around £200 such that pacemaker follow-up cost     the NHS around £50million per year. Most visits involve checking the battery and the leads     which, in the absence of symptoms might be unnecessary.      Pacemaker patients are at risk of developing other problems including heart failure which     puts them at higher risk of hospitalisation and death. For those under follow-up, no     mechanism exists to identify whether they might have heart failure, and for those receiving     new implants, it is unclear which will go on to develop heart failure. Also, whether optimal     heart failure treatment with a multidisciplinary team reduces the chances that they will be     hospitalised is also unproven.      Our study therefore has three main aims: 1) based on pacing indications and patient factors,     to identify which patients are likely to develop complications and therefore which patients     could be seen less frequently; 2) to validate and refine a simple risk score to help identify     which patients in pacing clinic should undergo screening for heart failure; and 3) to     establish whether such screening and subsequent optimisation of those with heart failure is     clinically and cost-effective for reducing hospitalisation and death.   "
112021|NCT01819649|"     This is a pilot study proceeding an intended international trial.      Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast     tablets will reduce the risk of cancer in healthy individuals.      Objective: The objective of this pilot study was to assess the viability of a full scale     randomised trial.   "
112022|NCT01819636|"     The aim of the study is to assess the beneficial effect of the short term consumption of the     highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low     mineralized water.   "
112023|NCT01819623|"     Supervised nonpharmacologic therapy improve cognitive function in patients with Mild     Cognitive Impairment   "
112024|NCT01819610|"     A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting     in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be     collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety     and efficacy of SPRIX.   "
112025|NCT01819597|"     Stroke due to intracranial arterial atherosclerosis is a significant medical problem,     carrying one of the highest rates of recurrent stroke despite best medical therapy, with     annual recurrence rates as elevated as 25% in high risk groups.      The goal of this investigation is to advance a promising surgical treatment for symptomatic     atherosclerotic intracranial stenosis - encephaloduroarteriosynangiosis (EDAS). The     investigation will test in a phase II futility trial the potential of EDAS for further     development before proceeding with the design of a definitive clinical trial of EDAS     Revascularization in patients with Symptomatic Intracranial Arterial Stenosis (ERSIAS).      The investigation is a 4-year futility trial to test the hypothesis that EDAS     revascularization combined with aggressive medical therapy warrants further evaluation in a     subsequent pivotal trial as an alternative to aggressive medical management alone for     preventing the primary endpoint of stroke or death in patients with symptomatic intracranial     arterial stenosis (Specific Aim 1). During the investigation the time course of     collateralogenesis and perfusion improvement following EDAS will also be evaluated (Specific     Aim 2.   "
112026|NCT01819584|"     The purpose of this study is to continue follow up of conservatively treated CHI patients and     to focus on their metabolic outcome, including frequency of hypoglycemia after discontinuing     treatment and incidence of diabetes mellitus in the long term.   "
112027|NCT01819571|"     The investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid     responsiveness would be reduced in patients with coronary disease who have diastolic     dysfunction.   "
112028|NCT01819558|"     Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent     allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after     reduced-intensity conditioning regimen.      If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days     after allograft.      6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.      The safety and immunological efficacy of this immune therapy after hematopoietic stem cells     transplantation with reduced intensity conditioning will be evaluated.   "
112029|NCT01819545|"     The miRNA 107 gene is increasingly appreciated to serve key functions in humans. The miRNA     regulate gene expression involved in cell division, metabolism, stress response, and     angiogenesis in vertebrate species. But the relationship and diagnosis capability of miRNA     107 and BACE1 mRNA gene expression in plasma and cerebrospinal fluid (CSF) of amnestic mild     cognitive impairment (aMCI) and normal control is still a mystery.   "
112030|NCT01819532|"     Anemia in preterm neonates is a significant problem encountered frequently in the neonatal     intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require     at least one blood transfusion during their hospital course and many will require repeated     transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections     and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and     placenta harbor up to 40% of blood available during fetal life. The current standard of care     is immediate umbilical cord clamping. The investigators are performing a randomized     controlled trial comparing immediate cord clamping to milking the umbilical cord prior to     clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize     that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping,     without delaying neonatal resuscitation.   "
112031|NCT01819519|"     The purpose of this study is to develop a brief screening and behavioral intervention for the     prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff     and feasible to implement as part of routine clinical prenatal care, and to test whether     behavioral intervention for susceptible pregnant women can lead to a behavioral change that     is likely to lead to decreased primary CMV infection. The study research assistants will     enroll pregnant women who are less than 20 weeks' gestation, either English or     Spanish-speaking and that do not have a primary CMV infection (never been infected or     previously infected). Enrollment will occur during the woman's prenatal visit.   "
112032|NCT01819506|"     Each year in the US, approximately 795,000 people have a stroke, and the overwhelming     majority of those who survive are unable to resume meaningful daily activities because of     impaired movement in one arm/hand. This study will investigate the effects of a challenging     4-week physical rehabilitation therapy program that is targeted at specific movement     impairments and systematically progressed to assure an ongoing just right level of rigor.     The investigators anticipate that therapy targeted to address specific movement impairments     will improve recovery of arm/hand movement in people who have had a stroke.   "
112033|NCT01819493|"     In response to the growing threat of obesity on the health of American children, specifically     African American children, the investigators propose to develop a program to educate and     motivate African American families to improve health behavior for obesity reduction and     diabetes prevention. This project will be unique in its partnership with local YMCAs and its     use of Family Health Coaches from the YMCAs who will work one-on-one with participating     families. The investigators feel this program will benefit all members of the families who     are enrolled and will encourage all members to participate though the study will target one     parent and one child who is 8 to 10 years old.   "
112034|NCT01819480|"     The purpose of this study is to learn more about the outcomes of treatment of throat and     voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option     involving the use of the da Vinci surgical robot to remove these cancers through the mouth.   "
112035|NCT01819467|"     The primary objective of this study is to determine whether the use of Seprafilm reduces the     incidence rate of adhesion formation following a primary C-section.      A secondary objective of the study will be to determine whether or not a correlation between     the adhesion score and the difficulty or delay in delivery of the infant exists.   "
112036|NCT01819454|"     The aim of the project is to define the frequency with which EER is present in patient with     chronic rhinosinusitis (CHR). The measurement will be carried out with a 24-hour monitoring     of the pH using the Restech system. This modern device is equipped with a narrow antimony     probe. The sensor is able to record not only liquid but also aerosol reflux episodes. The     second aim is to determine the relation among EER, CHR and asthma bronchiale. We will compare     the presence of reflux in three different patient groups (1. CHR without nasal polyposis,     without asthma bronchiale or ASA syndrome, 2. CHR with nasal polyposis, without asthma     bronchiale or ASA syndrome, 3. CHR with nasal polyposis and asthma bronchiale and/or ASA     syndrome). We expect to find a significantly more frequent presence of EER in patients with     CHR and asthma bronchiale or ASA syndrome. In case our hypothesis is confirmed, it will be     especially these patients(with a difficult to manage nasal polyposis) benefiting from the     antireflux therapy.   "
112037|NCT01819441|"     A. the controlling of the blood pressure, especially the variation of blood pressure, can     slow down the development of the small vessel disease.      B intensive BP control is more effective than normal control of blood pressure in slowing     down the small vessel disease.      C drugs of Calcium Channel Blocker(CCB) and Angiotensin-Converting Enzyme Inhibitor(ACEI)     have no significant difference in lowing the blood pressure and variability of blood pressure   "
112038|NCT01819428|"     The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the     efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line     monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.   "
112039|NCT01819415|"     The purpose of this trial is to detect the influence of omega-3 supplements on vitreous     levels of vascular endothelial growth factor (VEGF) in exudative age-related macular     degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are     randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula     with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and     EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these     patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines     and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a     potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition     and metobolite levels will significantly vary according to VEGF levels. Based on the results     of this pioneering clinical study, our research team will proceed to evaluate the individual     anti-angiogenic (vessel growth stopping) properties of the predominant Omega-3 metabolites     found.   "
112040|NCT01819402|"     Excess visceral fat is associated with chronic systemic inflammation and cardiovascular     complications. Pioglitazone has been reported to variably influence visceral fat volume, but     it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate     the effect of pioglitazone on glucose metabolism of fat tissue by using     18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)     imaging.   "
112046|NCT01819324|"     1. The purpose of the study is to test the effectiveness of a new mail-based intervention          for breast cancer survivors compared with standard lifestyle management and          no-treatment.        2. This intervention addresses both lifestyle factors such as dietary and physical          activities and psychological issues specific to breast cancer survivors to improve          healthy behaviors.   "
112047|NCT01819311|"     This project will test Attention Bias Modification Training (ABMT) among children and     adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for     anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose     of this project is to determine whether ABMT leads to reductions in anxiety and related     impairment, relative to a placebo task condition.   "
112061|NCT01819129|"     This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare     FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin     glargine and metformin in adults with type 2 diabetes.   "
112062|NCT01819116|"     The objective of this study is to quantify the association between tissue oxygen saturation     (StO2) during the donor management phase of the Death by Neurological Criteria (DNC) organ     donor and the number of organs transplanted per donor.   "
112063|NCT01819103|"     To investigate the causes of hospital variation in outcomes from acute coronary syndromes in     England and develop recommendations for improving patient care.   "
122769|NCT01679028|"     The purpose of this study is to see how safe an investigational new drug (T89) is and how     well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.   "
112048|NCT01819298|"     Patients with COPD (chronic obstructive pulmonary disease) suffer from episodes of acute     exacerbations leading to additional morbidity and mortality, and also a further decline in     lung function. It has been well-established that bacterial colonization is prevalent in COPD,     especially in moderate to severe COPD, and airway bacterial colonization is known to play an     important role in the development of pneumonia and exacerbations. On the other way, inhaled     corticosteroid (ICS) and long acting β2 agonist (LABA) were recommended in the treatment of     moderate to severe COPD. Though there were some evidences that ICS had some protective     effects on airway mucosa against bacteria invasion, the locally immunosuppressive effects of     ICS is still a concern. Indeed, the incidence of pneumonia was higher than the control group,     not only in the Towards a Revolution in COPD Health (TORCH) study but also in various studies     and meta-analyses.We hypothesized that airway bacteria colonization is associated with     disease severity, and that disease status can be identified by CAT (COPD assessment     test)scores and changes of CAT scores. We therefore conducted this prospective, observational     study in which CAT scores and sputum cultures were assessed in moderate to severe COPD     patients with the combination therapy of ICS and LABA every three months during the study     period. The primary end-point is the condition of potential pathogenic microorganisms (PPM)     colonization in view of CAT scores. The second end-point was the changes of PPM colonization     in association with CAT changes during follow-up. By the mean of CAT follow-up, it could     possibly provide a surrogate about the risk of exacerbation and pneumonia under the     combination therapy of ICS and LABA.   "
112049|NCT01819285|"     Objectives      I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time     of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local     curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention     (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).      II. Compare the overall survival of these two groups of patients.      III. Compare the time to first evidence of distant progression (N4 or M1) of these two     treatment groups.      IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these     parameters following endocrine therapy.      V. Study the prognosis of various sub-groups of patients stratified according to performance     status, local tumor extent, nodal status, and choice of endocrine treatment.   "
112050|NCT01819272|"     This study compared the effect of delayed-release metformin (Met DR) to placebo and extended     release metformin (Met XR) on glycemic control (fasting plasma glucose and HbA1c) and body     weight, and assessed the safety and tolerability of a range of doses of Met DR when     administered in subjects with type 2 diabetes mellitus (T2DM).   "
112052|NCT01819246|"     The overall aim is to reduce overall allogeneic transfusion requirements during cardiac     surgery when compared to standard management.      To evaluate this the investigators will test the hypothesis that intraoperative, autologous     platelet apheresis will primarily avoid allogeneic platelet transfusion. Following induction     of anesthesia and intravascular line insertion, the patient will be randomized to control or     treatment arms by sealed envelope technique where computer generated, randomization numbers     are assigned prior to enrollment based on study patient number which is never reused.      The control arm will have central venous access sham connected to the apheresis machine     Trima® (Terumo BCT, Denver CO); the treatment arm will be connected and undergo pheresis. The     clinical team will be blinded by a sterile sheet acting as a curtain and a recorded playback     of the typical sounds of the operation of the apheresis machine. At the end of the pheresis,     the platelet units will be disguised with opaque coverings and agitated at room temperature     in compliance with the American Association of Blood Banks (AABB) recommendations for     platelet storage. On separation from CPB, the blinded administration of autologous platelets     or allogeneic (blood bank) platelets will occur after protamine administration, if the     surgeon requests platelet transfusion (this is typically the case for these operations). The     surgeon will be blinded and he will order subsequent transfusions based on clinical evidence     of microvascular bleeding in accordance with standard guidelines, as is the investigators     practice for these operations.   "
112053|NCT01819233|"     This pilot clinical trial studies caloric restriction in patients with stage 0-I breast     cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease     progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill     tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor     cells.   "
112054|NCT01819220|"     Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to     RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS     inhibitors/calcium channel blockers are recommended as first line combination treatment for     hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium     channel blockers are not well defined. This study will compare the efficacy of RAS     inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance     and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint     will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing     2hour post prandial glucose compared to RAS inhibitors/diuretics.   "
112055|NCT01819207|"     thromboelastography can identify alteration in the coagulation profile in bariatric patients     who undergo sleeve gastrectomy or gastric bypass   "
112056|NCT01819194|"     This trial aims to establish a correlation between patient reported comfort while using soft     contact lenses and meibomian gland dysfunction (MGD).   "
112057|NCT01819181|"     The study will evaluate all female patients with severe aortic stenosis undergoing     transcatheter valve implantation with commercially available valves and delivery systems.   "
112058|NCT01819168|"     The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more     effective in treating patients with nocturia.   "
112059|NCT01819155|"     This study will provide the Senegal Ministry of Health with data on the safety and     immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose     seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data     will inform future policy considerations for influenza vaccine. The study is not powered to     detect significant differences between vaccines or groups, and no hypotheses are to be     tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.   "
112064|NCT01819090|"     Mechanical ventilation is one of the only treatment that has improved survival of patients     with neuromuscular respiratory failure. As disease progresses, some patients may require     longer ventilation period. Non invasive mechanical ventilation is the preferred method of     ventilation but it may interfere with speech and communication of patients who require     ventilation throughout the day. The investigators are evaluating the effect on speech and     communication of a ventilation device which allows patients to momentarily and voluntarily     withhold ventilation if they want to speak. This should allow the patients to have a more     fluid speech.   "
112065|NCT01819077|"     TMMR/tLNE was shown to result in very low locoregional recurrence rates and low morbidity in     surgical treatment of cervical cancer stage IB-IIA without any adjuvant radiotherapy even in     high risk situations. More and more this therapeutic strategy is implemented in clinical     routine in specialized cancer centres, thus, treatment of cervical cancer could be performed     for these stages in a systematically defined and reproducible radicality; adjuvant     radiotherapy could be spared for recurrent disease, thus lowering morbidity and resource     assignment in primary treatment dramatically. Due to the nerve-sparing character of the     procedure bladder, bowel and sexual dysfunction would also be minimized and markedly benefit     the patient.      This study is designed to follow up the results of this therapeutic concept adapted to     clinical routine in a multiinstitutional register study accompanied by detailed assessment of     pathological work-up, quality of life and bladder and sexual function following surgery.   "
112066|NCT01819064|"     An infants heart rate is very important because it ensures that blood is pumped to all organs     in the body. Heart rate may decrease during anesthesia and surgery, and this is why the     anesthesiologist will often give a medication to prevent this from happening. The most common     drug for this purpose is called atropine. The dose of most drugs given to babies is based     upon the baby's weight, but some believe that the dose of atropine should not be less than     0.1mg. However there is no evidence to support this minimum dose. A larger dose of atropine     may cause a very fast heart rate instead. Anesthesiologists routinely dose the atropine based     upon the baby's weight without regard for a minimum dose.      The purpose of the present study is to measure the heart rate after doses of atropine in     neonates and infants who receive less than 0.1 mg.   "
112067|NCT01819051|"     The purpose of this study is to evaluate the safety of treating human toenails with     atmospheric plasma (MOE Antimicrobial Plasma Treatment System) and get an initial evaluation     of the efficacy of this treatment for toenail fungus (onychomycosis).   "
112068|NCT01819038|"     This research project is a prospective study to compare mortality between early renal     replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil     gelatinase associated lipocalin (pNGAL) as a tool in decision- making.   "
112069|NCT01819025|"     The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy     (CBT) with a smartphone application, focused on providing support in homework assignments and     an increase in behavioral activation, is effective in treating mild to moderate depression.     The study will be conducted as a randomized controlled treatment study investigating the     effect of the current blended treatment compared to treatment as usual.   "
112070|NCT01819012|"     The purpose of this study is to determine Isoflurane's dose-dependent effect on left     ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging     (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane     concentrations would be analyzed by using intraoperative transesophageal echocardiography     (TEE) in cardiac surgery patients.   "
112072|NCT01818986|"     In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic     radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky     progressive disease, but also to provide antigen presentation and immune stimulation which is     expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T     and thereby significantly improve the treatment outcome for metastatic castrate resistant     prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic     cancer treatment   "
112073|NCT01818973|"     We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and     combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in     locally advanced nonmetastatic rectal cancer.   "
112074|NCT01818960|"     Revascularization strategies for ST elevation myocardial infarction (STEMI) study     (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting     multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial     infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients     presenting with STEMI and multivessel disease (MVD).   "
112075|NCT01818947|"     The purpose of this study is to understand real world gefitinib usage patterns, patient     characteristics and outcomes and to present these for a Caucasian population   "
112076|NCT01818934|"     The aim of the randomized controlled trial was to determine whether the addition of a general     or of a selective ultrasound screening program resulted in more appropriate criteria for     treatment and a reduced prevalence of late DDH compared with clinical examination alone.   "
112077|NCT01818921|"     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for     certain doses of beloranib in obese subjects with Prader-Willi Syndrome.   "
112078|NCT01818908|"     The major purpose of this clinical study is to assess clinical outcome of dose-adjusted EPOCH     regimen for patients with non-Hodgkin's lymphoma(NHL)-associated hemophagocytic     lymphohistiocytosis   "
112079|NCT01818895|"     The purpose of the study is to assess the dying process in critically ill patients with     decision to withdraw invasive mechanical ventilation in anticipation of death and to compare     effects of extubation and those of terminal weaning of mechanical ventilation on relatives     and care givers. The investigators primary hypothesis is that extubation is associated with     less symptoms of post-traumatic stress disorders in relatives, as compared to terminal     weaning.   "
112080|NCT01818882|"     The main objective of our study is to compare the effects of two care strategies for dyspneic     patients on the length of hospital stay: (1) standard care (=contextual analysis +     conventional clinical chest radiography) versus (2) standard care + pleuropulmonary     ultrasound.   "
112081|NCT01818869|"     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics     of multiple ascending doses of AZD8848 in healthy subjects.   "
112084|NCT01818830|"     The patients with sepsis are in the state of hypermetabolism, increased resting energy     expenditure, protein and fat catabolism disorder, negative nitrogen balance, insulin     resistance, hyperglycemia, and amino acid metabolism disorders. However, it is remain unclear     the changes of amino acids expression profiling in sepsis patients. In this study, the     investigators has planned to enroll 100 subjects, including 20 cases with systemic     inflammatory response syndrome (SIRS), 20 cases with sepsis, 20 cases with severe sepsis and     20 with septic shock. In addition, this study also include 20 normal cases as control. The     serum sample of patients with sepsis is draw on days 1, 3, 5, 7, 10, and 14 after first ICU     admission. High-performance liquid chromatography and tandem mass spectrometry was used to     detect the quantification of amino acids. The amino acids expression profiling contain     Arginine, Ornithine, Histidine, Cystine, Isoleucine, Cystathionine, Leucine, Homocystine,     Lysine, α-Amino-n-Butyric Acid, Methionine, Alanine, Phenylalanine, Anserine, Threonine,     β-Alanine, Tryptophan, β-Amino-Isobutyric Acid, Valine, Carnosine, γ-Amino-n-Butyric Acid,     Ethanolamine, Glycine, δ-Hydroxylysine, Serine, Hydroxy-L-Proline, Taurine,     1-Methyl-L-Histidine, Tyrosine, 3-Methyl-L-Mistidine, α-Amino-Adipic, Phospho-Ethanolamine,     Asparagine, Phospho-L-Serine, Aspartic acid, Proline, Citrulline, Sarcosine, Glutamic acid,     Argininosuccinic Acid, Glutamine, Homocitrulline. The investigators speculate that     measurement of amino acids expression profiling could be taken as an indicator for assessment     in critically ill patients.   "
112085|NCT01818817|"     The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral     block with single shot is a safe and reliable anesthetic technique in breast surgery.   "
112086|NCT01818804|"     Background: There is evidence for a high cardiovascular risk in rheumatic and inflammatory     diseases . Recent evidence suggest that psoriatic arthritis is also associated with an     increased cardiovascular risk with accelerated atherosclerosis and increased cardiovascular     risk. However, data regarding cardiovascular comorbidity and cardiovascular risk factors in     patients with psoriatic arthritis are limited.      Objective: The aim of this study is to investigate the effect of daily supplementation with 3     g n-3 polyunsaturated fatty acids on risk markers for cardiovascular disease and inflammation     in patients with psoriatic arthritis.      Design: Randomized double-blind, placebo-controlled, multicenter trial with n-3     polyunsaturated fatty acids in patient with psoriatic arthritis.      Setting: Departments of Rheumatology, Nephrology and Cardiology at Aalborg University     Hospital and Vendsyssel Hospital in Region Northern Denmark      Participants: 156 men and women aged > 18 years with psoriatic arthritis classified by the     CASPAR criteria will be included. Exclusion criteria: cardiac arrhythmias, conduction     disturbances, treatment with biological drugs or oral corticosteroids. Inclusion time: spring     2013 to spring 2015.      Method: The following data will be collected for each participant: Interview including     dietary records, assessment of tender and swollen joints, enthesitis, dactylitis, patient     global assessment of disease activity (Visual Analogue Scale ), global assessment of pain     (Visual Analogue Scale), psoriatic skin involvement by Psoriatic Area and Severity Index     (PASI), laboratory parameters of disease activity and risk markers of cardiovascular disease.      For detection of early cardiovascular risk markers Heart Rate Variability (HRV) and Pulse     Wave Velocity (PWV) will be performed.      Main outcome measures: The primary endpoint will be HRV and secondary endpoints will be PWV,     inflammatory activity and use of analgesics.      The trial is approved by The local Ethics Committee, registration number N20120076   "
112087|NCT01818791|"     As a nation, the U.S. invests heavily in community-based organizations to conduct     interventions, proven through research, to reduce the high rates of unplanned pregnancies and     sexually transmitted infections (STIs) and HIV among teens. Much less is invested in helping     communities implement these programs with quality. Although many research-based programs     exist to address teen pregnancy and STIs, communities face difficulty implementing them and     achieving the same outcomes as researchers. This gap is because resources are limited,     prevention is complex, and communities often lack the capacity—or the knowledge, attitudes,     and skills—needed to implement off the shelf programs well. Common ways to bridge this gap,     such as information dissemination, fail to change practice or outcomes at the local level in     part because it does not sufficiently address capacity of community practitioners. Therefore,     building a community's capacity is a method that could improve the quality of implementation     and outcomes. The proposed study will use a randomized controlled design and primary data     from middle school youth (960) and program staff from 32 cooperating Boys and Girls Clubs     (Clubs) to assess how a capacity building intervention called Getting To Outcomes (GTO)     augments the quality of implementation of a research-based intervention to improve teen     sexual health (Making Proud Choices, MPC). Specifically, the study will: (1) Assess the     utilization of and subsequent effects of GTO on program staff capacity to implement MPC; (2)     Assess the degree to which Clubs using GTO show greater improvements in MPC fidelity than     Clubs that are not using GTO; and (3) Assess the degree to which Clubs using GTO show greater     improvements on teen sexual health outcomes than the comparison Clubs. To address these aims     we will collect data on the delivery and utilization of GTO (e.g., method of delivery,     duration, topics); staff capacity to implement research-based interventions; observations of     program delivery (fidelity monitoring); and youth participants' sexual activity, pregnancy,     STIs, condom use, and knowledge/ attitudes towards sex. Analyses will examine differences     between intervention and control sites over time, accounting for clustering of youth within     site. These outcomes are important to NICHD's focus on providing opportunities for youth to     become healthy and productive adults.   "
112088|NCT01818778|"     Many volunteers visiting seniors make socially-based friendly visits. This study     investigated the efficacy of volunteers making visits focused on stimulating cognition.     Participants were randomly assigned to either a friendly visit control group or a cognitive     stimulation group. Seniors receiving stimulation visits made statistically significant     improvement in memory abilities.   "
112089|NCT01818765|"     Cardiac resynchronization therapy (CRT) is known to result in significant improvement in the     symptoms of selected patients with heart failure, and to reduce hospital admission and death     rates in these patients. CRT can improve cardiac function by improving the coordination of     the heart beat using a special pacemaker. This requires a wire in the coronary sinus, one of     the veins running around the outside of the heart, to stimulate the outside of the left     ventricle (main pumping chamber).      There are two particular issues with this standard technique. In some patients it is not     possible to get the wire into the coronary sinus due to difficult vein shapes, and in others     the wire can be put there, but it does not end up in a suitable position to act on the heart     enough to improve heart function. This is thought to be a major part of the reasons why one     in four patients does not improve with CRT (non-responders).      The investigators have developed a novel method of pacing the left ventricle of the heart by     putting the wire through a tiny hole made in the muscle between the left and right ventricles     and pacing the inside surface of the left ventricular chamber. This will allow patients in     whom the coronary sinus cannot be used to have CRT. The investigators will also offer it to     patients who have not improved with CRT, as there is evidence that they may respond to this     procedure due to physiological benefits from pacing the inside rather than the outside and     also the ability to steer the lead anywhere on the inner surface.      The investigators have performed this new procedure in a small number of patients already.     This study will allow closer follow-up of more patients, and also investigation of ways to     optimize results of the procedure for these patients.   "
112090|NCT01818752|"     The primary objective was to compare the progression-free survival of transplant ineligible     patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan     and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).   "
112093|NCT01818713|"     Leptomeningeal metastases (LM) develop when tumor cells reach the cerebrospinal fluid (CSF)     and infiltrate the leptomeninges. The median survival of patient with breast cancer and LM is     4-6 months with up to 25% long-term survivors. Many potentially highly efficacious     intravenous chemotherapies are currently not effective to treat LM because they do not     adequately cross the blood-CSF barrier.      Doxorubicin, the anthracycline chemotherapeutic agent, has a well-established antineoplastic     activity in breast cancer. To optimally enhance the delivery of liposomal doxorubicin to the     brain, to-BBB technologies B.V. has designed a glutathione (GSH) pegylated liposomal     doxorubicin hydrochloride formulation (2B3-101). Coating of liposomes with PEG ensures the     prolonged circulation time in plasma, whilst conjugation of GSH to the tips of the PEG     molecules targets the liposomes towards the active GSH transporters on the BBB to enhance the     delivery of doxorubicin to the brain.      This is a a clinical and pharmacological study that aims to determine preliminary efficacy of     treatment with 2B3-101 in patients with leptomeningeal metastases of breast cancer using the     LM response score.   "
112094|NCT01818700|"     The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of     NORSPAN® from baseline.      And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0)     the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's     overall satisfaction, and safety   "
112095|NCT01818687|"     The objective of this study is to assess the safety and tolerability of colestilan (MCI-196)     in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with     hyperphosphataemia, who are not on dialysis.   "
112105|NCT01818557|"     The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to     test their blood glucose at least four times daily. The investigators propose to     prospectively evaluate blood glucose testing done every day compared to every other day. The     primary goal is to establish the most cost-effective modality while still being able to     detect patients who require therapy in a timely fashion. The investigators plan to evaluate     this new management scheme utilizing a non-inferiority trial design.      The investigators primary research question is the following: When managing patients with     GDM, is every other day blood glucose testing non-inferior compared to every day blood     glucose testing, as measured by the difference of less than 5% in birth weight?   "
112096|NCT01818674|"     The Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor     Control in Jordan spans 51 months and aims to test the effectiveness of the Microclinic     Social Network Behavioral Health Program in influencing lifestyle behavioral risk factors to     improve diabetes management that effect weight and metabolic outcomes through social     networks. The Microclinic Social Network Behavioral Health Program provides microclinic (MC)     groups—consisting of approximately 2-8 individuals from pre-existing social networks     (friends, relatives, coworkers, neighbors, etc)—with shared access to diabetes education,     technology, and group support to promote weight and metabolic control through diet, exercise,     medication adherence, and blood pressure management. MC members play a role in the collective     effort to combat diabetes and solidifying self-management behavioral skills through     peer-monitoring and encouragement of lifestyle behaviors.      This Microclinic Social Network Behavioral Health Trial was established in collaboration with     the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).      This objective of the Microclinic Social Network Behavioral Health Trial, the first     randomized control study of its kind, is to test the effectiveness of the Microclinic Social     Network Behavioral Health Program. The study will yield valuable information on the impact of     social relationships with diabetes education on weight and metabolic control among     individuals with type 2 diabetes.   "
112097|NCT01818661|"     The study is designed to determine the relationship between structural and functional changes     in the brain on imaging and progression of speech and language, neurological and     neuropsychological features in patients with neurodegenerative apraxia of speech (AOS).   "
112098|NCT01818648|"     We plan to examine the gastrointestinal (GI) physiologic profile of Exenatide, a     glucagon-like peptide (GLP-1) analog as a possible intestino-trophic growth factor capable of     inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS),     with the potential to decrease parenteral nutrition dependence.   "
112099|NCT01818635|"     The purpose of the study to investigate whether montelukast lead to behavior problems in     children with asthma.   "
112100|NCT01818622|"     In this randomized controlled study we will investigate the effect of blue-blocking goggles     or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to     placebo. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The     main hypothesis is that virtual darkness therapy is effective as additive treatment in     mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep,     motor activity, circadian rhythm and mood also in the non-bipolar control-group.   "
112101|NCT01818609|"     Skeletal muscle mass declines with inactivity (casting is a good example) and increases with     activity (such as weightlifting). Whether muscle mass increases or decreases, is determined     by whether more new proteins within muscle are made than are broken down. The investigators     know that feeding protein increases the synthesis of new proteins but that the response of     older muscles to protein feeding is blunted compared with the young. This resistance of the     elderly to muscle building stimuli may be the primary reason that muscle mass is lost in     aging. The investigators also know that periods of muscle disuse such as casting result in a     person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new     muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at     approximately 1% for every year after. Elderly persons would likely fare well with advancing     age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is     a 'population view' and does not represent what occurs during short periods of muscle disuse     (i.e. during hospitalization or illness), which occur with increasing frequency in elderly     persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may     be worsened. The investigators will measure how quickly new proteins are made at rest and     after protein feeding in elderly men, before and after a 14 day period of reduced activity     brought on by having people reduce their daily step count.   "
120288|NCT01711437|"     THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL     PREPARATIONS FOR COLONOSCOPY IN CHILDREN.      THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING   "
112102|NCT01818596|"     This open-label, multicenter, multi-cohort study is to assess the safety, tolerability, and     efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF)     fixed-dose combination (FDC) tablet in treatment-naive and treatment-experienced     HIV-positive, adult participants with mild to moderate renal impairment.      The primary objective of this study is to evaluate the effect of E/C/F/TAF on renal     parameters at Week 24. The proportion of subjects achieving virologic response of HIV-1 RNA <     50 copies/mL will also be assessed.      At sites able to conduct the appropriate testing, approximately 30 participants will be     enrolled into an intensive pharmacokinetic/pharmacodynamic (PK/PD) substudy to evaluate the     PK/PD parameters of the individual components of E/C/F/TAF as well as tenofovir diphosphate     (TFV-DP).   "
112103|NCT01818583|"     Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract     at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the     general population. The prevalence of atrial fibrillation increases with age. Between 50 and     70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal     sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm.     Another treatment option for conversion of atrial fibrillation and atrial flutter is     electrical conversion. This is an effective treatment but requires anesthesia.      Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter     is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such     converting drugs all have potentially serious side effects and are expensive. Potassium,     sodium, calcium, and magnesium molecules are the most important ions causing electric current     in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial     flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium     infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this     would be an inexpensive treatment with potentially very few side effects.   "
112104|NCT01818570|"     The purpose of this trial is to evaluate the effect of a single PPC‐5650 dose in a human pain     model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the     esophagus.   "
112326|NCT01815684|"     The purpose of this study is to explore the safety (including the effect on cardiac     intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS     side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and     female subjects.   "
112106|NCT01818544|"     The primary objective of this study is to assess the safety and tolerability of 28 day oral     administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).      The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function,     biomarkers of inflammation and tissue damage, and the impact on overall health and perceived     well-being and to evaluate the pharmacokinetics of BAY85-8501.   "
112107|NCT01818531|"     This study will evaluate the affects of a single injection ultrasound-guided adductor canal     block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee     arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia     provided by the adductor canal block with that provided by single injection lumbar plexus     blockade. The working hypothesis is that the analgesia provided by the adductor canal block     will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome     will be a comparison of verbal numerical pain scores at rest and with movement over the first     24 hours following nerve blockade.   "
112108|NCT01818518|"     To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered     secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal     morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen     requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia     (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage     (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis,     necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal     hospital discharge.   "
112109|NCT01818505|"     Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease,     but the exact mechanism remained to be elucidated. Many connective tissue diseases such as     rheumatoid arthritis are often associated with antiphospholipid antibodies-associated     endothelial impairment. In the present study, the investigators will analyze the presence of     antiphospholipid antibodies in the serum of the patients with gout/asymptomatic     hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia     and gout. The investigators expect to find a correlation between these pathogenic antibody     and those cardiovascular co-morbidities.   "
112110|NCT01818492|"     The purpose of this study is to assess the safety, tolerability and efficacy of a new drug     aimed at controlling disease activity in patients diagnosed with primary haemophagocytic     lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients     not previously treated with the current standard of care, or can be given to patients who     have either failed or were unable to tolerate the current standard of care. Administration     will be on top of a glucocorticosteroid, which is usually part of the current recommended     treatment.   "
112111|NCT01818479|"     Open label, dose finding trial with two treatment arms ( high-TBI and low-TBI conditioning     regimens) to assess the efficacy of Treg/Tcon addback to CD34 selected partially matched     related donor stem cells. The maximum tolerated dose will be established using 3 patients per     dose level and there will be an expansion cohort at the MTD.   "
112112|NCT01818466|"     The aim of this study is to evaluate the clinical and radiographic outcomes of patients who     have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate     fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal     tibia.   "
112113|NCT01818453|"     The goal of this project is to determine whether genetic information can be used to predict     response to an internet-based treatment of depression. Several studies now indicate that     completing an internet-based treatment for depression, called Deprexis, can significantly     improve symptoms of depression. However, not everyone improves. The purpose of this study is     to determine whether genetic profile can predict who is likely to improve.   "
122770|NCT01679015|"     Evaluating the percentage of patients that suffer from eye allergies and determining whether     they also have dry eyes.   "
112114|NCT01818440|"     Background:      - Researchers are interested in comparing two methods that doctors can use to position     catheters in blood vessels. These methods are used to deliver chemotherapy and close the     blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way     called 3-D Roadmap. The 3-D Roadmap software uses computed tomography (CT) images to help the     doctor choose the best position for the catheter to get to the tumor. The computer shows the     route on an x-ray screen in real time. This technique may help doctors position the catheter     with less x-ray dye and in a shorter time. These methods will be compared in people who are     having a procedure to destroy liver tumors. The procedure, called trans-arterial     embolization, will deliver chemotherapy and destroy the tumor blood supply.      Objectives:      - To compare the effectiveness of fluoroscopy or 3-D Roadmap software for liver tumor     treatment.      Eligibility:      - Individuals at least 18 years of age who are having trans-arterial embolization for liver     cancer.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide blood and urine samples, and have imaging studies.        -  Participants will be divided into two groups. One group will have regular fluoroscopy          (X-ray) during the procedure. The other group will have the procedure with the 3-D          Roadmap software.        -  In the first group, participants will have a CT scan. The doctor will decide how many          vessels need to be treated. The doctor will advance the catheter using fluoroscopy only.          Another CT scan will be given after the procedure.        -  In the second group, participants will have a CT scan. The doctor will look at the scan          with the 3-D Roadmap software. The software will show the path to advance the catheter.          The doctor will use the software to help destroy the tumors. Another CT scan will be          given after the procedure.        -  Both groups will have the same follow-up care afterward. Other tests will be given as          needed for the cancer treatment.   "
112115|NCT01818427|"     To determine the effect of the prehospital infusion during air transport of 2 units of AB     plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional     care.   "
112116|NCT01818414|"     Cervical preparation before second trimester dilation and evacuation (D&E) reduces risks and     complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied     for cervical preparation. However, the optimal method for cervical preparation, especially     for D&E procedures that occur on the same day as cervical preparation, is not known. This     study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical     preparation for same-day D&E between 16+0 and 20+6 weeks gestation.      HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours     prior to D&E as an adjunct to cervical preparation with Dilapan-S will decrease operative     time for same-day D&E performed between 16+0 and 20+6 weeks.   "
112126|NCT01818284|"     The goal of this clinical research study is to learn if treating stem cell donors with     filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of     blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of     these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs     to be performed.      Researchers will study if using both drugs lowers the risk of the stem cell transplant     recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in     which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's     body.      The safety and effectiveness of this drug combination will also be studied.      Filgrastim and plerixafor are both designed to help move or mobilize the stem cells from     the bone marrow to the blood.   "
112117|NCT01818401|"     Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10%     yearly increase since the early 1990s. The clinical experience shows a strong rate of success     on pain relief and on function. Longevity of the implants has been shown to be determined by     the biomechanical design of the prosthesis, and by the implantation technique, especially the     correct positioning of the bone cuts during the surgery. To improve the precision of these     cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to     the patient's anatomy, improving the reliability of this procedure. A reduction of the     surgery time lengh and bleeding would be other benefits expected with this type of ancillary.     The objective of this trial is to study the reliability of patient matched cutting blocks for     total knee arthroplasty, by both clinical and radiological assessment, the effect on     morbidity reduction during and after the procedure and also the benefit it could bring on an     economic point of view.   "
112118|NCT01818388|"     A multicenter prospective single arm interventional trial in hospitals where therapeutic     hypothermia is standard practice. This trial will enroll 50 subjects to evaluate the ability     of the ZOLL Intravascular Temperature Management (IVTM) System to induce, maintain, and     reverse mild therapeutic hypothermia and maintain normothermia post cardiac arrest.   "
112119|NCT01818375|"     Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and     overall complications in patients undergoing abdominal surgery, there is a need to address     the effect of implementing GDFT on the incidence of specific surgical complications and in a     context of en enhanced recovery program (ERP). Specifically, studies investigating the impact     of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal     surgery and using an ERP are missing.      It is hypothesized that the incidence of primary POI will be reduced in patients receiving     intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after     elective laparoscopic colorectal surgeries with an ERP program.   "
112120|NCT01818362|"     This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50.     The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and     MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of     the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will     be recruited simultaneously to control for seasonal changes in influenza. This is because at     certain times of year there is likely to be a higher naturally acquired T cell response to     influenza than at other times due to circulating influenza virus in the community.      The study has been extended to include 2 additional groups (group 5 & 6), each containing 12     healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and     group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.   "
112131|NCT01818219|"     Due to recent technological improvements, it is now possible to record the electrical     activity of the diaphragm (Eadi), a direct expression of the central nervous system     respiratory center activity. By providing a relatively easy-to-use technique to record Eadi     the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to     explore the effects of various interventions on neural inspiratory activity in human subjects     during spontaneous and assisted ventilation both for normal and simulated abnormal     respiratory mechanics.      The main aim of this project is to measure and compare the components of Eadi signal, the     direct reflect of the respiratory centers activity, under various conditions of normal and     simulated altered respiratory mechanics (either obstructive or restrictive respiratory     mechanics° in order to better understand the neuroregulation of breathing. The second aim of     the present project is to perform a similar analysis regarding the effects of various modes     (Pressure Support and NAVA) and various levels of assisted ventilation both in case of normal     and abnormal respiratory mechanics. Based on the information recorded on Eadi and flow and     pressure signals, the last aim of this project is to correlate Eadi and pneumatic derived     parameters both during spontaneous breathing and assisted ventilation.      Practically, by using the NAVA recording technology, the investigators will perform a     physiological study on normal volunteers to explore the effects of normal and simulated     abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and     transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing.     Thirty healthy volunteers with documented normal lung function tests will be included in the     study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and     respiratory mechanics will be simulated in 15 healthy volunteers).   "
112121|NCT01818349|"     Background: A discrepancy between strength gain and gait changes following various training     programs aimed at improving gait function after stroke has been noted. A mismatch between the     training program and gait parameters could explain this finding.      Objective: To evaluate the impact of an isokinetic-strengthening program, matching the     requirements of the affected lower-limb muscle groups involved in the energy generation of     gait, to a control intervention, on gait performance and muscle strength.      Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce     greater changes in gait performance and strength than a control intervention not aiming at     training these muscle groups.      Design: Single-blinded randomized controlled trial.      Participants: A convenient sample of 30 individuals with chronic hemiparesis.      Interventions: Participants were randomly assigned into two groups (n=15), each training     three times/week for six weeks. The experimental group trained the affected plantarflexors,     hip flexors and extensors concentrically, while the control group trained the affected     upper-limb muscles.      Main outcome measures: Baseline values and post-training values, taken at the end of the     training program, of maximal voluntary concentric strength, gait speed and peak positive     power.   "
112122|NCT01818336|"     A self- or parent-reported history of penicillin allergy excludes approximately 10% of the US     population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000,     Neugut et al. 2001). Yet approximately 80% of patients labeled as allergic to the penicillins     can safely take these antibiotics without fear of a life-threatening reaction (Gadde et al.     1993, Macy et al. 1997). The outcomes of this erroneous classification of patients include     unnecessary denial of an effective and well-tolerated class of antibiotics, which are often     the treatment of choice.      The primary aim of skin testing with the Penicillin Skin Test Kit is to identify subjects at     very low risk of developing acute IgE-dependent reactions when given a penicillin or     cross-reacting drug. The negative predictive value (NPV) of skin testing is assessed by oral     challenge with a penicillin.   "
112123|NCT01818323|"     The overall goal of this study is to investigate the safety of T4 immunotherapy when     administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck     (SCCHN) that is not suitable for conventional active therapy.      The investigators propose to conduct an open-labelled, non-randomized, dose-escalation phase     I trial in which autologous T4+ T-cells are administered to patients with SCCHN. T-cells will     be engineered to express a second generation chimeric antigen receptor (CAR) named T1E28z.     Engineered T-cells will be injected directly into the tumour site. Patients will not be     lymphodepleted. A classical 3+3 design will be employed, with dose escalation from 10^7     through to 10^9 transduced T4+ T-cells, dependent upon toxicity monitoring. It is anticipated     that up to 30 patients will be enrolled over the course of the study.   "
112124|NCT01818310|"     The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from     bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity     in patients with diabetes mellitus type II., intraarterially into the defect of the limb or     with an intravenous application only, has a greater potential to improve the perfusion in the     ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out     differences among three different therapeutic types of BMAC application, to define their     effectiveness and safety and to compare the impact of different means of application to the     speed of healing of the limb defects and the improvement of perfusion parameters.   "
112125|NCT01818297|"     The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve     Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of     chronic, intractable post-surgical back pain in adults.   "
112127|NCT01818271|"     Stroke patients clearly benefit from intensive and coordinated inpatient care. While     inpatient rehabilitation care is the preferred form for many patients post-stroke, due to     access and financial barriers, many patients do not have this option. Community, outpatient     rehabilitation programs will allow the patients with moderately disabling strokes the     opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation ,     while allowing some patients with mild disability to avoid inpatient rehabilitation     completely.      Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of     treating adults who have suffered a single stroke using the following essential treatment     components; a) community setting, b) group activity program, c) flexible, task-specific,     computer-based exercise regime This program is designed to allow an extension of the     in-patient rehabilitation experience to a community-based setting, in a cost-effective manner     using paraprofessional staff and rehabilitation specialists, to provide a challenging,     functional program to promote recovery and independence from physical impairments affecting     balance and walking.      The specific objectives are to:        1. assess the benefits and feasibility of the multi-functional group exercise intervention          for balance and mobility in a community setting. Secondary objectives        2. identify effective combinations of exercises & activities that translate to increased          abilities and participation levels.      Hypothesis: Intense training targeting standing balance, and walking will significantly     improve stroke clients' functional mobility. Training in a group setting and incorporating     interactive and engaging computer gaming further provides the benefits of motivation and peer     support while providing treatment in a cost effective manner.   "
112128|NCT01818258|"     HIV-infected children from sub-Saharan Africa often present with severe malnutrition. In     severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate     antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to     weight ratio in severely malnourished children could also place them at higher risk of under     dosing compared to children with mild to moderate malnutrition. However, limited data are     available on the pharmacokinetics of ARVs in severely malnourished children. This study will     address this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine     (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children, compared to     children with normal nutrition to mild malnutrition.   "
112129|NCT01818245|"     This study will include two groups (cohorts) of participants:      In Group A, this study will look at the amount of LY2605541 that is present in the body after     it is injected in 3 different locations in the body of the same participant. At least 16 days     will pass between each injection.      In Group B, the study will look at how the body absorbs, distributes, and gets rid of     LY2605541 in participants over age 65.      Participants may enroll in only one group.   "
112130|NCT01818232|"     This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent of     elimination of a single oral dose of 400 mg [14C]LX4211 to healthy male subjects   "
112284|NCT01816230|"     A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit     (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in     Patients with Hematological Malignancies.   "
124090|NCT01661608|"     The primary objective is to collect data on the use of the EndoSurgical Operating System     (EOS) for gastric tissue approximation during primary gastric restrictive procedures.   "
112132|NCT01818206|"     Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been     investigated in animals. The aim of the present study is to evaluate the efficacy of     bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A     cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic     fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages     strains in sputum samples collected. Then the sensitivity of individual colony will be     tested.   "
112133|NCT01818193|"     A monocentric prospective open study to evaluate the frequency and nature of cognitive     complications in the 3rd month post pulmonary transplant.   "
112134|NCT01818180|"     Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract     infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).   "
112135|NCT01818167|"     The purpose of this study is to compare the efficacy of Provodine™ topical cream to 10%     benzoyl peroxide topical body wash for the treatment of early stage hidradenitis suppurativa.   "
112136|NCT01818154|"     The purpose of this study is to validate a new hand held light emitting diode (LED) device     for the measurement of minimal erythema dose (MED) for narrow band Ultraviolet B (UVB)     radiation by comparing to the traditional approach of measurement of the minimal erythema     dose.   "
112137|NCT01818141|"     The purpose of this study is to compare number of vegetative cells and spores in stool over     time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C.     difficile infection.   "
112138|NCT01818128|"     The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided     double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.   "
112139|NCT01818115|"     The objective of this study is to demonstrate the ability of the Hydrus Implant to lower     intraocular pressure in glaucoma patients undergoing cataract surgery.   "
112140|NCT01818102|"     The purpose of this study is to investigate the appropriate window setting of chest computed     tomography to select a correct size of double-lumen endobronchial tube.   "
112141|NCT01818089|"     The aim of this study is to investigate if any correlation between lung sounds of pneumonia     patients and the clinical development or therapy of the pneumonia exists.   "
112142|NCT01818076|"     This study will evaluate the long-term safety of botulinum toxin type A for the treatment of     moderate to severe crow's feet lines after repeat application.   "
112143|NCT01818063|"     This randomized phase II trial studies how well carboplatin and combination chemotherapy with     or without veliparib works in treating patients with stage IIB-IIIC breast cancer. Drugs used     in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Veliparib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. It is not yet known whether giving     carboplatin and combination chemotherapy are more effective with or without veliparib is more     effective in treating breast cancer.   "
112144|NCT01818050|"     Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for     resolution of biliary obstruction has been the method of choice for many years. However,     stent clogging/obstruction is a major limitation in the management of biliary obstruction.     Studies have shown that the conventional tubular type polyethylene stents (CS) with side     holes accumulate significant sludge and their mean patency is approximately 90 days.      Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3     months.      Recently, a stent with a star-shaped cross-section has been developed for biliary     applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary     stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent.     The stent which is star shaped in cross section, channels fluid along its winged perimeter.     It has been proposed that the winged stent design with a lack of central lumen obviates the     risk of luminal occlusion and that the risk of occlusion, given the presence of multiple     external drainage channels, is smaller. Longer term biliary drainage without the need for     stent exchange should therefore be possible with these stents.      The primary aim of this study is to prospectively evaluate the patency rate of the WS up to     90 days in 50 patients with biliary obstruction due to stones or benign strictures.   "
112145|NCT01818037|"     Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.      In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus,     glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of     cataract surgery.      In our previous study, the investigators examined the intraoperative performance and     postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients     before their first birthday. At 1 year, the postoperative results showed that good visual     outcomes could be obtained in microphthalmic eyes.      Since only a few studies have reported outcomes, and that too only short term of cataract     surgery on microphthalmic eyes, in this prospective observational study we evaluated the     long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators     examined the outcomes, complication rates, influence of age at surgery on pattern of axial     growth and central corneal thickness and visual and orthoptic assessment in these eyes.   "
112146|NCT01818024|"     This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and     pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or     intravenous (IV) routes in healthy subjects.      Part 1 of this study will involve an initial assessment of safety, tolerability and     pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a     predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will     occur which will assess key comparability criteria to inform progression to Part 2 of the     study.      Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or     close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes     of administration, in sequential manner, respectively. An interim data review will also occur     after completion of Part 2, where all data accumulated previously will be assessed to examine     appropriateness to progress to Part 3.      Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous     routes using the same dose administered in Part 2.   "
112297|NCT01816061|"     Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD   "
112147|NCT01818011|"     The primary objectives of this study are to assess the safety, tolerability and     pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration. GSK1322322     shows broad spectrum antibacterial activity against pathogens involved in respiratory tract     infections as well as methicillin-resistant S. Aureus (MRSA).      This study consists of three parts (Part A, Part B and Part C). The results from Part A of     this study will enable use of large-scale, commercial tablets produced for administration to     patients in pivotal clinical trials of GSK1322322. The results from Parts B and C will     support enrolment of Japanese subjects in future clinical studies. Additionally, the results     will support the dose selection for further clinical development of GSK1322322 in     hospitalized patients with severe bacterial infections in Japan and other Asian populations.      In Part A, subjects will undergo screening, 4 treatment periods receiving single dose of each     of: 1500 mg Initial, fit-for-purpose tablet (product code AP), 1500 mg Over granulated tablet     (product code AR), and the 1500 mg and 2000 mg of intended commercial tablets (product code     AU).      In Part B of the study subjects will undergo screening, and be randomized to receive 3 doses     of GSK1322322 oral cohort (100 mg, 1500 mg and 2000 mg) or IV cohort (600 mg, 900 mg and 1200     mg) each in 3 treatment periods.      Part C will be a single-blind, placebo-controlled, repeat dose study of GSK1322322 in healthy     Japanese male subjects. GSK1322322 will be administered (fasted) via IV for 4 days BID,     followed by administration of GSK1322322 orally (fed) for 6 days BID. A follow-up evaluation     will be conducted 7-10 days following last dose of for each subjects in each Part of the     study.      Approximately 12 subjects will be enrolled in each part of the study such that approximately     8, 6, and 9 subjects complete dosing and critical assessments in part A,B, and C     respectively.   "
112148|NCT01817998|"     Background and study concept:      Atrial fibrillation is the new global epidemic in cardiology. With improved survival from     other cardiovascular diseases and longer living in general, the incidence and prevalence of     AF rise dramatically in all developed countries with an estimated life time risk of one in     four for all people above the age of 40 years. Similarly in Denmark, the prevalence is     estimated to almost double within 2020. It is a fatal arrhythmia with doubled mortality     compared to patients with normal sinus rhythm; this primarily caused by an increased risk of     stroke and heart failure. In particular stroke is a feared complication with a 70% risk of     fatal outcome or lasting handicaps and immense costs for each patient as well as in terms of     health costs.      Moreover, many AF patients experience a variety of symptoms and have markedly reduced quality     of life. Opposed to heart failure patients and patients who have suffered from a myocardial     infarction, AF patients are not offered any sort of rehabilitation when diagnosed.      Pharmacological treatment of the arrhythmia is challenging. Most often, individual and     careful risk evaluation including ultrasound of the heart is obligatory to choose optimal     treatment strategy and prophylactic anticoagulation. In case a new anti-arrhythmic drug is     started to restore and maintain sinus rhythm, hospitalization for at least two days with     heart rhythm monitoring is required to detect any possible potentially dangerous or even     fatal arrhythmia as a side effect to the treatment. Additionally, the first new oral     anti-arrhythmic AF drug introduced for more than twenty-five years proved to be hazardous in     a high-risk AF population and is now only used with strict precautions.      To explore the role of alternative treatment strategies and to renew handling of cardiac     arrhythmia, we have therefore set out to study the role of physical exercise in AF patients.      Our specific study aims are to examine:        1. The effect of physical exercise on AF burden        2. The effect of physical exercise on the risk of cardiovascular hospitalization      Method:      Our study is an interventional, randomized exercise study. 60 patients older than 18 years     with ECG-documented AF will be included if written informed consent is obtained. They will be     randomized 1:1 to moderate-severe (80-85% of max capacity) or low intensity (50% of max     capacity) training. Exclusion criteria are language barrier, illness inherent with an     expected survival shorter than a year, other reasons preventing the patient from training,     revealed serious cardiac disease during pre-tests, AF ablation within one year, permanent AF.      Both groups are first participating in a nurse-led educational and care program. The program     is built on two individual consultations and one team consultation with focus on education in     AF.      The patients will be thoroughly examined before randomization and after ended training period     with special ultrasound of the heart, ECG-monitored test of maximal oxygen uptake on     ergometer bicycle, 24 hours measurement of blood pressure and pulse, and blood samples. They     will all be taught to use home ECG recorders, a new handheld device. The patients will send     ECG's twice daily and if the experience cardiac symptoms for 5 months (during exercise and     two months after).      When randomized the patients will be divided in teams of ten and trained on separate teams,     so the physiotherapist closely can guide the patients in training at the correct intensity     level.      Measurements:      During and after physical exercise the burden of atrial fibrillation is measured by tele-ECG     i.e. number of ECGs with atrial fibrillation divided by total number of ECGs. ECG reporting     begins after four weeks of physical exercise and continues 2 months after last training     session.      Recording of hospitalization begins after randomization and continues one year after last     training session. All hospitalizations caused by AF or related to the AF disease (relapse of     AF, heart failure, stroke, new anti-arrhythmic medication, elective electrical cardioversion,     complications to anticoagulation, pacemaker implantation) are recorded. Also, total days in     hospital are registered.      The AF population is growing on a global scale and the disease attracts immense interest on     all international cardiology congresses. New knowledge of the effect of training for the     general population as well as the effect in the setting of established disease could have     paramount effect for prognosis, quality of life, and health costs as pharmacological     treatment is AF still holds challenges.   "
112149|NCT01817985|"     This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the     Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe     hepatic impairment.   "
112150|NCT01817972|"     This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine)     versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic     Scoring in Crohn's Disease) score.      It is a trial where the investigators are administering biological therapy by itself and     biological therapy plus an immunosuppressive medicine in combination to see which form of     therapy has a better effect on healing ulcerations in the small intestine and colon that are     due to a flare up of Crohn's disease.   "
112151|NCT01817959|"     The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear     neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the     first low molecular weight blocker of CXCL8 biological activity in clinical development.     Thus, the use of reparixin may emerge as a potential key component in the sequentially     integrated approach to immunomodulation and control of non specific inflammatory events     surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D)     patients.   "
112161|NCT01817829|"     It is a double blinded randomized control trial assessing the use of Oral paracetamol in     managing the intrapartum pain.   "
112162|NCT01817816|"     Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke     patients. They cause disabled condition of patients in activities of daily life and     functional performance, and also accidental falls and subsequent fractures.      This study is to evaluate and compare the effects of different phase injection of Botulinum     Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone,     functional performance, gait pattern and energy consumption in stroke patients.   "
112163|NCT01817803|"     To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure     patients   "
112152|NCT01817946|"     Myotubular myopathy (XLMTM) is an X-linked disorder caused by mutations in the myotubularin     gene (MTM1). The clinical spectrum is variable and ranges from individuals who require a     wheelchair and full time breathing support to those who are able to walk and breathe on their     own. Symptoms of myotubular myopathy include long faces, facial weakness with eye muscle     weakness, breathing support with a muscle biopsy demonstrating central nucleated fibers.     These symptoms may be caused by mutations or changes in the MTM1, BIN1 (bridging integrator     1), DNM2 (dynamin 2) and RYR1 (ryanodine receptor 1) genes. However, the majority are caused     by mutations in the MTM1 gene. Some patients with symptoms consistent with myotubular     myopathy who initially have negative testing of the MTM1 gene were later found to have a     unique type of change in the MTM1 gene. This unique change, called a deletion or duplication,     can be found with a different type of genetic test called a CGH (comparative genomic     hybridization) array.      Investigators do not know how frequent deletions and duplications are in patients with     X-linked myotubular myopathy. Recently, there have been advances in identifying potential     treatments for XLMTM. The next step will be to proceed with clinical trials of potential     treatments. In order to be ready for clinical trials, it is important that investigators find     the specific genetic change that is causing XLMTM in people with this diagnosis. This study     will attempt to find changes in the MTM1 gene in individuals who have clinical symptoms     consistent with a diagnosis of XLMTM. Participants will be asked to enroll in the CMDIR     (Congenital Muscle Disease International Registry), complete a brief clinical survey, provide     access to medical records, and provide a saliva or blood sample for genetic testing. Results     of genetic testing will be communicated to participants by the physician specified in the     consent by the signing person.      Study Hypothesis:      Not all individuals with a clinical diagnosis of XLMTM have access to genetic testing.     Investigators know that deletions and duplications of the MTM1 gene can cause XLMTM.     Investigators will find more individuals with XLMTM by performing genetic testing of the MTM1     gene, including CGH array for deletions and duplications.   "
112153|NCT01817933|"     The recovery of range of motion and muscle power after surgical intervention of the fracture     will mostly affect patient's daily activities. So postoperative rehabilitation program will     play the important role. Correct and effective physical therapy will reduce the functional     impairment of limbs after long term casting or surgical fixation, and accelerate to recover     the independent daily activities. There is no consensus between immediate or delay and the     duration of continue physical therapy will improve the shoulder function、muscle power and     degree of satisfaction( physiological function、social function、mental health、 pain、 general     health status ) after surgical fixation of fractures. This study will evaluate the patients     of the fracture that including of the humeral neck fracture, vertebral fracture, distal     radial fracture and hip fractures after surgical fixation, to see the difference of fracture     healing time, function recovery and pain sensation after intervention of physical therapy at     different time point.      From this study, we hope to discriminate the timing of intervention and duration of physical     therapy which is the key factors for postoperative prognosis of fractures fixation, and to     set up the perfect rehabilitation program in ChangHua Christian Hospital. The results of this     study will improve the discomfort of fracture patient's recovery or reduce the complications     rate, and set up the standard treatment policy of our hospital , also was the model of other     hospitals.   "
112154|NCT01817920|"     Falls are very common accidents in Hospital. It not only results in injuries, less mobility     among patients but increases their length of stay, cost and family burdens. Reducing the     rates and injuries of falls is an urgent issue around hospitals.      An integrated multidisciplinary fall prevention program (IMFPP) was implemented from 2006 in     CCH. Members include physicians, nurses, case manager therapists, engineers and staffs of     maintenance. The aim of this study is to determine whether IMFPP efforts support     interventions with multiple components do reduce the fall rates and severity of injuries.   "
112298|NCT01816048|"     The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate     treatment response in bone metastases in subjects with prostate cancer treated with the     investigational drug, TAK-700.   "
112155|NCT01817907|"     In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep.     This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an     increased risk for developing high blood pressure. Currently, the best treatment for     obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose     (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the     upper airway from closing in most people, many people have difficulty sleeping with the mask     in place and therefore do not use the CPAP treatment. This research study is being conducted     to learn whether using a sedative will improve OSA severity by altering some of the traits     that are responsible for the disorder.   "
112156|NCT01817894|"     Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six     months after a period with six laser treatments for hair removal.   "
112157|NCT01817881|"     The purpose of this study is to determine whether temporal artery thermometers are accurate     tools in temperature measurements of patients presenting to the Emergency Department. The     investigators´ hypothesis is that there is a difference of > 0,3 degrees centigrade     (Bland-Altman) between the temperatures measured with the temporal artery thermometers used     at the investigators´ hospital (Exergen TAT-5000) and those measured with rectal thermometers     (OMRON MC-341-E), which is considered to be the gold standard in Denmark defined by the     Danish Center for Clinical Guidelines. The investigators furthermore hypothesize that the     difference between these measurements is greater if measured in a patient with hyperthermia     (temperature > 37,9 degrees Centigrade).   "
112158|NCT01817868|"     The project is an observational, multi-central, prospective, non-interventional and     open-label data collection study on secondary prophylaxis with recombinant FVIII products in     adolescents and adults with severe hemophilia A (FVIII < 1%).      It will be a controlled observation of patients on secondary prophylaxis versus on-demand     treatment regimen. Patients will be enrolled preferably on a 1:1 basis with regards to     prophylaxis and on-demand treatment.      The patient enrollment period will be 2 years with a follow-up (observation period) of 2     years for each patient. Based on the primary effectiveness parameters (joint bleeds and     overall bleeds per year) an observation period of 2 years is considered sufficient although     it has to be admitted that it is rather short to assess the progression of orthopedic status.     Previously treated prophylaxis patients with at least 50 exposure days and patients with     continuing prophylaxis treatment will be included.   "
112159|NCT01817855|"     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics     of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic     obstructive pulmonary disease.   "
112160|NCT01817842|"     This is a study of the effectiveness of mobile phone support for the D.C. Tobacco Quitline.     The project will test the efficacy of a web-based system that uses mobile phones to improve     quit rates at 3-month intervals, relative to standard quitline services. Under the standard     model, relatively infrequent, periodic support is provided to smokers who want to quit and     seek out the services. The new system will complement that effort by increasing the quality,     frequency and accessibility of quit smoking support - when and where the smoker needs it     most. It is hypothesized that successful abstinence rates will improve to the degree that     participants utilize the support system and engage with the quitline.   "
112165|NCT01817777|"     MTF116086 is an open-label, randomised, parallel-design study in subjects with type II     diabetes. The study is site-based, with local pharmacies serving as the sites and pharmacists     as principal investigators for the sites. All subjects will enter an initial 8-week     observational phase during which purchase behaviour and compliance with usual metformin use     will be observed and recorded. At the end of the observational phase, subjects will be     randomised to one of the two arms (metformin small pack vs. metformin large pack) for a     20-week interventional phase. The medication in the interventional phase is provided to the     subjects free of charge. HbA1c will be collected for all subjects during Week 0, Week 8, and     Week 28. Subjects will be asked questions about their tablet compliance, their satisfaction     with the pack size they received and reasons for missing doses throughout the interventional     phase by the pharmacist. The pharmacy visit on Week 28 will be end of the study.   "
112166|NCT01817764|"     This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The     purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol     (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who     meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the     end of the run-in period, approximately 710 eligible subjects will be equally randomized (to     complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1.     UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via     the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and     evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg     administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo     administered once-daily in the morning via NDPI. A safety Follow-up assessment will be     conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if     applicable). The total duration of subject participation will be approximately 15 weeks.   "
112167|NCT01817751|"     This phase II trial studies how well sorafenib tosylate, valproic acid, and sildenafil     citrate works in treating patients with recurrent high-grade glioma. Sorafenib tosylate,     valproic acid, and sildenafil citrate may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
112168|NCT01817738|"     The purpose of this study is to determine whether the new RNActive®-derived prostate cancer     vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic     metastatic prostate cancer that is castrate resistant.   "
112226|NCT01816984|"     This pilot randomized phase I/II trial studies the side effects and best dose of PI3K     inhibitor BKM120 when given together with cetuximab and to see how well it works in treating     patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the     ability of tumors to grow and spread. Others find tumor cells and help kill them or carry     tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may     kill more tumor cells   "
112169|NCT01817725|"     Background:      The HBsAg clearance rate in interferon-treated responders is significantly higher than that     in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.     There is a good chance to further increase the cure rate if the investigators can enhance the     HBV-specific immune response when the HBsAg level already comes to a low level.      Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients     whose HBsAg already <=2000 IU/ml.      Patients and methods:      This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no     hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine     (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one     year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose     during the treatment period and every 3 months for another year following the last dose.     Viral and cellular factors will be studied to discover determinants affecting HBsAg     clearance.      Aims        1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate          chronic HBV infection in patients with low titer HBsAg.        2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as          to design a feasible schedule for future clinical trials in a larger group of patients.        3. To discover viral and host factors which can be used as biomarkers for personalized          vaccine therapy.   "
112170|NCT01817712|"     The primary objective of CSP#589 VIP-STAR is to evaluate the effectiveness of Individual     Placement & Support (IPS) in unemployed Veterans with PTSD. The primary hypothesis is that,     compared to those treated with transitional work program (TWP), unemployed Veterans with PTSD     treated with IPS will be significantly more likely to become a steady worker. A steady worker     is defined as holding a competitive job for greater than or equal to 50% of the 18-month     study follow-up period (i.e., greater than or equal to 39 of the 78 weeks). All participants     will be followed for 18 months post-randomization.      12/14/12: Analytic plan augmented to allow for a sensitivity analysis of the primary outcome     that would exclude the first 12 weeks post-randomization, and evaluate between group     proportion of steady worker status, as defined by working in a competitive job for greater     than or equal to 50% of the weeks during week 13-78.      7/1/13: Analysis plan has been augmented to include a logistic regression analysis of the     primary outcome, adjusted for participating medical center.      10/4/13: Addition of the IPS-25 Fidelity Scale. The addition of the IPS-25 scale should     increase the validity of study results.      1/15/15: Addition of an Interactive Voice Recognition/Web-based (IVR/Web) System; as an     option for weekly data capture of the primary outcome data (employment history).      8/17/15: Approval of Supplemental Data Collection at Participant Study Exit; use of the data     collected will supplement the study analysis plan and, provide further insight into the     impact of vocational rehab. A Participant Satisfaction Survey will allow study participants     to indicate their level of satisfaction with the study, vocational rehabilitation     intervention and, suggestions for future research.   "
112171|NCT01817699|"     The purpose of this study is to evaluate the effect of anemia correction and vitamin D     supplementation in kidney transplant recipients.   "
112191|NCT01817439|"     Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity.     Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at     high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention,     delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach,     aimed to reduce the incidence of phlebitis is a valuable clinical and research goal.      Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the     treatment of AF of recent onset (duration < 48 h).   "
112327|NCT01815671|"     A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to     systematically evaluate the diagnostic utility and incidence of adverse events in women using     standard horizontal compared to lateral tilt down positioning for colonoscopy.   "
112172|NCT01817686|"     Default options represent the events or conditions that are set into place if no alternatives     are actively chosen. The setting of default options has well-established effects on a broad     range of human decisions, but its influence on patients' preferences for end-of-life care is     only beginning to be understood.      This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness,     assessing the impact of Advance Directive (AD) forms framed with different default options.     The central goals are to assess how default options in ADs influence the end-of-life care     choices made by patients at risk for critical care, and these patients' hospital and ICU     utilization.      The investigators hypothesize that setting defaults in real ADs will increase the proportion     of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending     therapies such as mechanical ventilation and dialysis, and reduce the proportion of time     during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient     satisfaction with end-of-life care planning.   "
112173|NCT01817673|"     There is a claim that creatine supplementation might affect kidney function, especially in     those consuming a high-protein diet. The aim of this study was to investigate the effects of     creatine supplementation on kidney function in resistance-trained individuals ingesting a     high-protein diet.   "
112193|NCT01817413|"     Children often damage their front teeth. In approximately 6% of cases, the nerve inside the     affected tooth dies (becomes 'non-vital') and natural root development stops. In these cases,     the tooth requires a root canal treatment in order to prevent problems such as pain and     dental abscesses from arising. However, because the roots of these young teeth are not fully     formed, they are weaker and prone to fracture. In addition, root canal treatment is difficult     because a root canal filling cannot be placed in a tooth which is not yet fully formed, due     to the fact that the root has an 'open' end.      To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of     the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral     Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the     tooth. However, although they help to provide a barrier, they do not help to strengthen the     walls of the root. Treatment with these materials requires multiple visits to the dentist,     over a period of up to 18 months.      There is evidence to suggest that an alternative treatment involving 'revascularisation'     (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows     'natural' root growth to restart, and also strengthens the walls of the root. Treatment can     often be carried out in just two visits.      The aim of this study is to discover whether there is a difference between one of two methods     of treating non-vital teeth with open ends. It is thought that there will be no significant     differences seen between the results of the two techniques.      Children with teeth that fall into this category and require root canal treatment will be     given one of two treatments, both of which aim to treat infection, close the root end and to     allow healing to take place.      Teeth will receive one of the following methods of root treatment:        1. Revascularisation (recovery of the natural blood supply to the tooth) following          placement of an antibiotic paste into the tooth root. The aim of this treatment is to          allow 'natural' root growth to restart. Root growth will allow the tooth to form at          barrier at the end of the root. No root canal filling will then be necessary.        2. Closure of the open root end by placement of an artificial barrier at the end of the          root so that a root canal filling can then be placed. This will be done with a dental          material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are          routinely treated in this way at Liverpool Dental Hospital.   "
112174|NCT01817660|"     Weakness in the wall of a blood vessel located behind the knee (popliteal artery) which leads     to a swelling of this blood vessel (aneurysm) is one of the most common types of arterial     aneurysms. It is associated with significant risk of blood clot formation, narrowing of blood     vessel which can create a serious threat to individual's health. Currently, approved     treatment options for this condition include both open surgical and endovascular stent-graft     repairs.      In the open repair procedure, the blood vessel behind the knee is tied up or removed and a     small artery is created using a vein on the same leg. This is also called a bypass procedure.      In the endovascular repair, using X-rays, doctors places a stent in the blood vessel. Stent     is a small device similar to a thin tube. When it is placed in the right location, your     doctor can open it. When stent is opened, it supports weakened blood vessel and blood goes     through it. The weakened artery then shrinks around the stent.      The OVER-PAR is a short name for this study. Many hospitals in the United States agreed to     participate in this study. Patients are randomized to undergo either open or endovascular     repair because they can be treated with either of the procedures. Investigators use the short     names OPAR for open surgical repair and EPAR for endovascular repair. People who have an     aneurysm that is larger than 2 cm (about an inch) can participate in this study.      The purpose of this study is to compare outcomes after these two standard procedures.   "
112175|NCT01817647|"     Procalcitonin (PCT) is a biomarker used to monitor serious bacterial infections and guide     antibiotic therapy. Anastomotic leak (AL) after colorectal surgery is a severe complication     associated with relevant short and long-term sequelae. The aim of our study is to assess the     predictive value of PCT level for early diagnosis of anastomotic leak after colorectal     surgery.   "
112176|NCT01817634|"     New approaches are needed to prevent growth failure in children from low- and middle-income     countries (LMIC). To date, nutrition intervention studies have focused on micronutrient and     energy content of complementary foods and have yielded only small to moderate effects on     growth and development. There appears to be a missing link that mediates and reduces the     expected beneficial effect. Child populations in LMIC show an asymptomatic environmental     enteropathy that is characterized by a reduced size of the small intestinal villi, decreased     gut integrity and a chronic inflammatory response in the gut. Results from studies in     industrialized countries suggest that ω3 long-chain polyunsaturated fatty acids (ω3 LCPUFAs)     improve immune response and gut integrity. These reported beneficial effects could result in     even more important physiological implications for children from LMIC and will ultimately     contribute to their healthy growth and development.      The hypothesis of the OME³Jim study is that an increased intake of ω3 LCPUFAs through     complementary foods and human milk has an effect on infant growth and development in a     context of high malnutrition rates and low ω3 LCPUFAs intake. This study will identify     whether intake by either or both mother and infant is more effective.      The specific objectives of the OME³Jim study are:        1. To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement          on infant growth, morbidity, nutritional status and development;        2. To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on          infant growth, nutritional status and development;        3. To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating          mothers and infant on infant growth, morbidity, nutritional status and development:        4. To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and          human milk.   "
112177|NCT01817621|"     The purpose of this study is to develop and test counseling strategies for men who have sex     with men (MSM) who are living with HIV and are experiencing body dissatisfaction.      Two phases will be conducted throughout the course of the study.      Phase 1: Develop an intervention for HIV-infected MSM that addresses body dissatisfaction and     self-care. (NOTE: currently, only Phase 1 will be recruiting participants, Phase 2 will not     be active for several months)      Because of the prospective syndemic relationship between body dissatisfaction and depression,     the investigator will integrate the most efficacious interventions for body dissatisfaction,     depression, adherence, and sexual risk reduction, and tailor them to HIV-infected MSM. The     investigator will then conduct an iterative process of pilots and exit interviews about     feasibility, acceptability, and the strengths and weaknesses of the intervention until the     intervention is maximized. Up to 9 participants will be involved in Phase 1.      Phase 2: Conduct a two-arm randomized control trial comparing the newly developed     intervention to a treatment-as-usual condition.      As a first step in addressing the efficacy of the newly developed intervention, the     investigator plans on randomizing up to 60 participants into either the newly-developed     intervention or a treatment-as-usual condition. Participants will be assessed at baseline, 3     months (acute outcome), and 6 months postrandomization. The primary outcome variable is body     image disturbance. Depression, HIV sexual transmission risk behaviors, and highly active     antiretroviral therapy (HAART) adherence will serve as secondary outcomes.      Study hypotheses for the two phases include:        1. The investigator will be able to develop and implement a feasible intervention that          integrates addressing and relieving body dissatisfaction with increasing health related          behavior change in MSM with HIV. Adequate recruitment (at least 80% of goal) and          retention (at least 80% to follow up) in the trial will be an indicator of success for          this aim.        2. Those who receive the intervention will show improvements in health behavior outcomes          (medication adherence, HIV transmission risk behavior) and will show reduced body          dissatisfaction and depressive symptoms.   "
112178|NCT01817608|"     The investigators objective is to assess quality of life and functional outcome in patients     requiring short-term mechanical ventilation. Additionally, the investigators plan to measure     the recovery of peripheral muscle strength and respiratory muscle strength during recovery.   "
112192|NCT01817426|"     The purpose of this study is to determine whether infliximab can favourably and safely be     discontinued in patients with Crohn's disease in sustained complete clinical, biochemical,     and endoscopic remission on infliximab.      Further to examine the clinical utility of measuring levels/activity of infliximab and     activity of anti-infliximab Ab in patients in sustained complete remission, in order to     investigate whether pharmacoimmunological data can predict the clinical outcome and     rationalize therapeutic management of these patients with respect to continuation or     discontinuation of infliximab therapy. Additional, to investigate the optimal time-point, out     of three, to measure this activity.   "
112328|NCT01815658|"     The aim of this study is to present a novel Intramedullary Nail (IMN) made of CFR - PEED     composite, that is biomechanically tailored to closely match cortical bone. This IMN should     promote fracture healing and prevent stress shielding osteopenia.      Case records of patients with humurus shaft fracture will be retrospectively reviewed to     determine whether the implant promotes bone healing.   "
112194|NCT01817400|"     The study is seeking to understand how being overweight and obese makes women less fertile.     The studies the investigators have done so far indicate that there is a hormone or other     substance produced by fat that goes into the blood and reduces reproductive hormones in women     who are overweight and obese. The present study will try to find the most promising     substances by studying small numbers of women and trying to remove the substances that are     causing the problem.      Hypothesis: A circulating factor or factors, either hormonal, inflammatory or metabolic,     causes relative pituitary hypofunction and correction of this reproductive deficit will allow     obese women with infertility who have failed to reduce their body weight to normal to     conceive, and may also prevent the horizontal passage of an adverse metabolic phenotype to     the offspring.   "
112251|NCT01816659|"     The goal of this clinical research study is to learn more about the possible effects of     metformin extended release (ER) in patients with colon cancer or adenomas who are about to     have surgery. The safety of this drug will also be studied.      Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is     also designed to block a protein in tumor cells that is important in tumor growth and blood     vessel development. This may cause cell death or reduce the spread of the disease.   "
112179|NCT01817595|"     Background      With the emergence of the internet, health care professionals are changing the way they     approach diabetes management. Internet Blood Glucose Monitoring Systems (IBGMS) are aimed at     keeping blood glucose levels normal or in the range of acceptable levels to prevent the     complications associated with diabetes. The Principal Investigators have completed a     randomized clinical trial supporting the efficacy of IBGMS (1,2).      Patient satisfaction of reporting platform is essential to encourage patient reporting and     participation in IBGMS. In this study, we wish to compare two different types of meters which     will be used to internet blood glucose monitoring: the BG Star Meter (Conventional Meter),     and the iBG Star Group (iPhone Technology).      Purpose and Rationale      Patients who are more satisfied with their meter and internet reporting platform are more     likely to participate in an internet monitoring system. Patients often lack the motivation to     report to their endocrinologist. With increased reporting to their healthcare professional,     patients are more likely to benefit from such a system. This study aims to compare two types     of meters and their respective internet reporting platforms to encourage patient     participation.      Objectives      Our main goal is to compare the two types of meters.      Primary Outcomes Include:        1. Patient Satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire          (DTSQ)        2. Frequency of reporting to endocrinologist        3. Number of Self-Monitoring Blood Glucose (SMBG) tests        4. Time taken to teach each patient the platforms      Research Design/Methods      Sample Size: 50 patients will be randomized into two groups:      BG Star Group (Conventional Meter) 25 patients will use the (conventional) BG star meter in     which patients will upload their readings onto a computer and send in their readings via     email.      IBG Star Group (iPhone Technology) 25 patients will be randomized to the iBGstar system will     upload their readings to their iPhone and send in their readings using the iPhone.      Patients will be recruited from a Physician's private office.      Both the (Conventional meter) BG star and iBG star (iPhone Technology) group will be asked to     perform SMBG 3 or more times per day and to upload their metered glucose values online every     2 weeks to be reviewed by the doctor.      Inclusion criteria:        -  Type 1s        -  Type 2s, can be on insulin, oral antihyperglycemic agents, or in combination.        -  Willingness to test blood glucose levels a minimum of 3 times daily        -  Willingness to be randomized        -  Trained in self-blood glucose monitoring        -  Internet Access      Exclusion criteria: Patients who do not meet the above criteria or are not willing to     participate will not be included in the study.   "
112180|NCT01817582|"     This study is being conducted to investigate the safety, comfort, and tolerability of 3     treatments: Lotemax® gel 0.5% administered twice daily (BID)with or without Restasis 0.05%     administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety     visit 1 week post-treatment. This study will also investigate the relative efficacy of     Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID     and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of     keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week Treatment Period and at     the end of a 12-week Treatment Period.   "
112181|NCT01817569|"     The purpose of this investigation is to describe general safety profile of type II Diabetes     Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices.   "
112182|NCT01817556|"     This is a multicenter, active-controlled, randomized, double-blinded, paralleled group     clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients     with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three     times a day for four weeks.   "
112183|NCT01817543|"     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a     prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be     treated using AutoloGel and case-matched against a concurrent cohort of patients receiving     undefined Usual and Customary Care (UCC)   "
112184|NCT01817530|"     This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety     and efficacy of elagolix alone and in combination with add-back therapy versus placebo on     heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.   "
112185|NCT01817517|"     This research is being performed to try to understand if the use of deep brain stimulation or     DBS can treat the symptoms of Tourette syndrome that do not respond well to current     medications. In order to do this the investigators will place small stimulation leads on both     sides of the brain in a region (a portion of the thalamus) that may alter the abnormal     activity in the brain contributing to the symptoms of Tourette syndrome. This requires two     surgical procedures, and several preoperative and postoperative visits for tuning the     stimulation parameters and recording stimulation effects. The FDA has not approved DBS for     use in people with Tourette syndrome, and Medtronic (the manufacturer of the device) has not     conducted testing for the system in Tourette syndrome. Therefore its use in this study is     experimental.   "
112186|NCT01817504|"     Our hypothesis is early and systematic transplantectomy under a well-conducted     immunosuppression is associated with a decreased risk of anti-HLA immunization against a     conservative attitude including a gradual reduction of immunosuppression, with or without a     transplantectomy performed for cause (clinical event).      Observation or Investigation Method Used :      The study is :        -  multicenter        -  prospective        -  open        -  randomized: patients are divided into two parallel groups:             -  study group: transplantectomy within six weeks after return to dialysis,               antiproliferatives stop at the start of dialysis, Maintenance               anticalcineurin-based-immunosuppression without dose reduction up to two weeks               after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after               transplantectomy. Corticosteroids: 5mg per day until one month after               transplantectomy then stop within one month.             -  control group: No systematic transplantectomy. Antiproliferatives stop at the start               of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then               stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3               months.      In the case of transplantectomy for cause in the control group, immunosuppression will be     continued at the maintenance dose during the current surgical procedure, and withdrawn two     weeks later,similary to systematic transplantectomy.   "
112187|NCT01817491|"     The purpose of this study is to investigate the short-term effects of a reduced fat     plant-based diet on biomarkers of inflammation, oxidative stress and cardiovascular risk.     This plant-based diet consists of whole grains, fruits and vegetables and little amounts of     nuts and seeds, with no limitations on the amount of food intake. Animal products are not     allowed. The results of the plant-based diet will be compared with the diet recommended by     American Heart Association. This diet also emphasizes fruits and vegetables, but allows     healthy fats, low-fat meats, fish and low-fat dairy in moderation. The results of the study     might be useful in understanding whether or not plant-based diets are protective against     cardiovascular disease.   "
112188|NCT01817478|"     The investigators want to find out if there is any difference between the microbiotic flora     lining the conjunctiva of medical staff that work in the hospital and others who do not work     in the hospital.   "
112189|NCT01817465|"     This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in     treatment of the patients with functional dyspepsia. The study is conducted with following     methods: multi-centers, double blind, randomization, parallel. The subjects will receive     Motilitone® or/and Pantoline®.   "
112195|NCT01817387|"     This project will result in the development of a personalized intervention strategy to     improve motivation for treatment engagement and functional outcomes in individuals with a     recent onset of schizophrenia. Motivational impairment is arguably the single most important     factor that determines a patient's ability to engage in and adhere to effective treatment. In     our study, sixty participants will be enrolled in a randomized controlled trial comparing the     feasibility and tolerability of two types of motivational interventions (Daily Goals or     PRIME), and a neuroplasticity-based cognitive training program. Participants are randomized     to either receive Daily Goals or PRIME for 8 weeks, after which, both conditions will also     receive an 8-week course of cognitive training delivered via iPads. Participants will undergo     pre/post-testing and a 6-month follow-up to determine feasibility and efficacy of the     interventions. By enhancing motivation, schizophrenia patients would be able to engage more     fully with treatment and develop full and productive lives. This study may also pave the way     forward for other health conditions in which motivational impairments impede health outcomes.      All assessments will be conducted at the University of California, San Francisco; however, we     offer some assessments to be done remotely.   "
112196|NCT01817374|"     1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to          neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale          ultrasound and post-treatment mammography findings utilizing final surgical pathology          and clinical outcome.        2. Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion          measurements and enhancement patterns in predicting tumor response to adjuvant treatment          in clinical studies.      The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound     (echocardiography) of the heart. Definity® will be used off-label (during ultrasound of the     breast) in this study. The administration of Definity® during this study will follow total     dose guidelines approved by the FDA.   "
112197|NCT01817361|"     The public health impact of this study will be the application of the greater understanding     of the oral health status, oral health related behaviors, and quality of life of patients     with systemic sclerosis (scleroderma or SSc). It is hoped that risks and protective factors     can be identified to be associated with the oral health status of adults with systemic     sclerosis,leading to the development of interventions for improved oral health in this     population,and providing the basis for a larger study of oral health problems of adults with     systemic sclerosis.   "
112198|NCT01817348|"     1. Therapeutic exercise, especially stretch exercise and joint mobilization, remain the          mainstay of conservative treatment of frozen shoulder.             1. Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect.             2. Manipulation or arthroscopic release under general anesthesia may avoid pain during               the intervention; however, increased risk of humeral shaft fracture and failure of               release of pathological tissue were reported.        2. We consider intra-articular injection is a compromized way, from a practical point of          veiw, to reduce the pain during physiotherapy.        3. We hypothesize that, intra-articular injection with lidocaine before joint mobilization          and stretch exercise, can make the patient pain-free during physiotherapy, and the          effect of combined therapy is superior to physiotherapy alone in the treatment of frozen          shoulder.   "
112199|NCT01817335|"     This pilot clinical trial studies psycho-educational program in increasing knowledge and     satisfaction and decreasing distress in younger patients with cancer receiving treatment.     Psycho-educational program may increase knowledge and satisfaction and decrease distress in     younger patients with cancer receiving treatment   "
112200|NCT01817322|"     To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of     Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation     without an increase of incidences of adverse events, such as biopsy confirmed acute     rejection, local or systemic infections, and bone marrow suppression.   "
112235|NCT01816867|"     The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This     registry will collect data from 100 patients treated for a ventral hernia repair.   "
112236|NCT01816854|"     In this prospective study, a newly developed self-expanding nitinol stent is evaluated for     the treatment of atherosclerotic lesions in the superficial femoral artery.   "
112201|NCT01817309|"     Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in     Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent     peritonitis remains the major cause of peritoneal failure. A reliable predictor of relapsing     peritonitis is invaluable in the management of PD peritonitis. Recent studies showed that     bacterial-derived lipopolysaccharide (LPS) fragments are present in clinically used fluids     such as dialysis fluid. LPS are thought to be derived from microorganisms inhabiting body     fluid. The investigators hypothesize that the presence of LPS in PD effluent is a predictor     of relapsing peritonitis in PD patients. The investigators plan to study 300 patients with PD     peritonitis. After inform consent, specimens of PD effluent will be collected on the day of     initiating antibiotic treatment, every 5 days until the day of completing antibiotic     treatment, and then 28 days later for the test of LPS level. All patients will be followed     for one year after completion of antibiotic therapy for the development of relapsing,     recurrent, or repeat peritonitis episodes. Our study would explore the use of detecting LPS     in PD effluent as a non-invasive tests for the prediction of relapsing peritonitis.   "
112213|NCT01817153|"     The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8     hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic     vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between     post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound     imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by     near-infrared spectroscopy).   "
112214|NCT01817140|"     The primary objective of this study is to improve the diagnostic accuracy and specificity of     MRI in detecting the degree of bone involvement and invasion in oral cancer. The presence and     degree of bone invasion determines the extent of surgery and has great effect on the     morbidity of patients with oral cancer and bone/soft tissue tumors.      MRI scanning in 3 Tesla (3T) and 4Tesla (4T) MR magnet will be performed on up to 10 patients     with possible maxillofacial and/or mandibular bone invasion. We will then compare the     conventional imaging results of the patients with 3T and 4T MRI results and post operative     pathology results.   "
112202|NCT01817296|"     Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. It     appears scar tissue forms in these boys' testicles, leading to progressive destruction over     their lifetimes. Advanced reproductive technology can be used to surgically retrieve sperm     from these individuals, but these methods have a 50% failure rate in adult Klinefelter     patients. Younger men have higher success rates, suggesting that adolescence and young     adulthood may be the best time to extract sperm, but these techniques have not been studied     in Klinefelter patients younger than 26 years of age. Additionally, there is currently no way     to predict which Klinefelter patients will have success with these methods and which of them     will not. This trial will explore sperm extraction in Klinefelter syndrome in an age range     (12-25 years) that has never been studied, with the ultimate hope of improving the potential     for fertility in these patients. The specific goals of this study are to determine the ideal     age for sperm retrieval in Klinefelter patients and to establish factors that can be used to     predict which of these patients will have a higher likelihood of success with advanced     reproductive technology. The hypothesis is that younger Klinefelter patients will have higher     sperm retrieval rates.   "
112203|NCT01817283|"     This study is a prospective, multicenter, randomized, placebo-controlled clinical trial, to     evaluate impact of Triptolide wilfordii on T cell immune activation and inflammation     biomarkers in HIV-infected immunological non-responders.   "
112204|NCT01817270|"     The purpose of this study is to observe the occurrence of adverse events, seroconversion rate     and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.   "
112205|NCT01817257|"     This is a two year, multicentre, mixed methods feasibility study including a randomised     controlled two-arm interventional trial, a nested qualitative study, focus groups and a     United Kingdom (UK) wide survey exercise.   "
112206|NCT01817244|"     Suicide is a significant cause of death in Korea. According to the report compiled by the     Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National     Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in     the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and     Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons     who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when     they committed suicide. Therefore, this study aimed the impact of a care management     intervention on depression treatment and reducing suicidal ideation in elderly patients with     depression.   "
112207|NCT01817231|"     This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with     breast cancer and 120 control women, to evalyate if vitamin D status is associated with     breast cancer risk.   "
112208|NCT01817218|"     INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all     the assistance levels, and they have big repercussion referring to individual, social and     labour levels, supposing a big consumption of human and material resources.The cure with     autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a     decrease in the cicatrization time comparing to conventional methods in hospital levels,     which becomes interesting contrasting its efficacy in primary care.      AIM:Evaluate the practicability, security and potential of the autologous PRP in the     treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid     environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP     classification).      DESIGN:A pilot study will be executed, which will consist in a randomized clinical test,     multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers     will be studied, who will be between the age of 40-80 years old, and who will be attached to     five health centers. Variables for the identification, following, result and patient profile     have been defined. Emphasize the variables of ulcer area decreasing, CIVIQ index, % one     cure per week .   "
112209|NCT01817205|"     The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and     TACE for unresectable HCC   "
112210|NCT01817192|"     The optimal treatment for stage I non-small cell lung cancer (NSCLC) remains controversial.     Radiographic surveillance alone has been recommended for stage I patients after the tumor is     removed surgically from the lung, and this standard has been based on the fact that no     previous clinical trial has demonstrated a benefit for stage I NSCLC patients who receive     post-operative chemotherapy. These patients, however, have a substantial risk of death within     five years after operation, ranging from approximately 30% to 45%, largely due to metastatic     disease that is present immediately after surgery but that is undetectable by conventional     methods. Some leading organizations therefore currently recommend post-operative chemotherapy     as an alternative standard of care in stage I NSCLC patients who are considered to be at     particularly high-risk. Up until now, however, there has not been a well-validated means to     identify stage I NSCLC patients at high risk of death within five years after operation. A     new prognostic tool, the Pervenio™ Lung RS Assay, which has been validated and definitively     demonstrated in large scale studies to identify high-risk stage I patients with non-squamous     NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is     therefore now possible to compare the outcomes of patients randomly assigned to one or the     other of these competing standards of care.   "
112211|NCT01817179|"     The purpose of this study is to evaluate how a functional electrical stimulation (FES) device     worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy     walk and perform other functional activities.      The investigators expect to find that wearing the functional electrical stimulation device     will improve walking and other functional activities of children with hemiplegic cerebral     palsy. Participants will be trained in use of the device and will be required to wear it     daily for 3 months. Each participant will be evaluated before beginning the intervention and     after completing the intervention. This study will provide important information regarding     the benefits of this treatment intervention in children with hemiplegic cerebral palsy.   "
112212|NCT01817166|"     The main objective of this study is to evaluate the efficacy and tolerance of 2 years of     treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome     at high risk for MS (CIS).   "
112374|NCT01815034|"     Use of trancutaneous CO2 (TC02) monitoring to aide in titration of sedation of midazolam and     fentanyl. Trancutaneous readings validated with invasively obtained specimens from existing     arterial sheaths required during AF and VT ablations (trans-septal and retrograde aortic     respectively)   "
112216|NCT01817114|"     During a heart attack, an artery carrying blood and oxygen to the heart becomes blocked,     which causes damage to the heart muscle. When possible, a clot-busting drug is given or a     procedure called angioplasty is performed soon after a heart attack starts, to open up the     blocked artery and restore blood flow to the heart. While this can be an effective treatment     to reduce permanent damage to the heart, patients can still experience heart failure     afterwards. Consequently many patients require medications to support their heart after a     heart attack. Recent research has shown a new technique called Remote Ischemic conditioning     or RIC, is effective at protecting the heart muscle in a heart attack. RIC is produced simply     by repeated inflation and deflation of a blood pressure cuff on an arm or leg to temporarily     cut off and then restore blood flow to that limb. The investigators believe this triggers the     release of molecular factors that protect heart muscle. In a recent study in humans, it     reduced the amount of permanent damage to the heart muscle when applied before the     angioplasty procedure. The investigators recent animal studies have shown that RIC may also     help the heart muscle recover after a heart attack if applied everyday during the month after     a heart attack, by preventing heart failure. This is important for two reasons: first,     currently the investigators can only treat heart failure with medications, and second, some     people have heart attacks but are not suitable to have angioplasty and so are at greater risk     of heart failure. Daily RIC may provide an easy and effective new treatment to prevent heart     failure after a heart attack. This application proposes a preliminary study in humans to see     if daily RIC can help heart muscle recovery after a heart attack.   "
112217|NCT01817101|"     The purpose of this study is to determine whether an omega-3 fatty acid supplementation is     effective in the prevention of progressive cognitive decline in elderly people aged 75 years     or older.   "
112218|NCT01817088|"     Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of     Parkinson's disease. This procedure performed in two steps using electrophysiology. This     study is a prospective, randomized and monocentric study to compare two DBS procedures with     or without electrophysiology.      A better control of targeting and trajectory is necessary before not using electrophysiology,     which is the reference procedure. A new definition of sub thalamic nuclei with new MRI     stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of     operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei     without the need of electrophysiology.      Two groups of patients will be followed: a first group of patients with a procedure under     general anesthesia alone without electrophysiological stimulation and a second smaller group     of patients with a first step of electrode implantation under awake surgery with     electrophysiological stimulation followed by a second step under general anesthesia for the     implantation of stimulator.      Clinical results will be assessed at 6 months after implantation.   "
112219|NCT01817075|"     This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it     works compared to control cleansing in preventing central line associated bloodstream     infection and acquisition of multi-drug resistant organisms in younger patients with cancer     or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream     infections and bacterial infections associated with the central line.   "
112220|NCT01817062|"     Objective:      Due to high mortality rates the capillary leakage and the acute abdomen are important risk     factors of the probability of survival. The aim of an optimal therapy of the acute abdomen     within the neonatal period is beside the cure of the underlying disease the prophylaxis of     capillary leakage with the help of optimised intra- and postoperative volume therapy.      Question:      Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit     from early increase of the haemoglobin/haematocrit by optimised volume therapy with     crystalloid and colloidal volume as prophylaxis of the capillary leakage?   "
112237|NCT01816841|"     This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk     patients and patients undergoing routine dental care. Diagnostic procedures, such as direct     visual fluorescence, may help find and diagnose oral cancer.   "
112221|NCT01817049|"     Soccer accounts for more than 10% of all sport injuries in youth requiring medical attention.     The injury rates in youth soccer where there is no established injury prevention program are     estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000 participation     hours. Risk reductions ranging from 32-43% have been found for youth players participating in     neuromuscular training programs, such as the FIFA 11+, that include agility, balance     training, and strengthening components. Although studies have shown that the FIFA 11+ is     effective at reducing injuries, there is poor uptake of the program in the youth soccer     community. It is therefore important to develop ways of delivering the program to soccer     coaches and players in order to maximize its protective benefit. The Health Action Process     Approach (HAPA) is a behavior change theory that has been used to successfully predict the     uptake of health behaviours in a number of populations, such as cancer screening and     exercise, but has not been tested in sport injury prevention settings.      The primary objective of this study is to examine the effect of a HAPA-based coach education     intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the     course of one outdoor and one indoor season. The secondary objective is to examine the     dose-response relationship between program adherence and injury, comparing program adherence     and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches     receive a HAPA-based intervention will have greater adherence to the program than teams whose     coaches do not receive the intervention, and that that injury incidence will decrease as     adherence to the program increases. It is expected that program adherence will be lower and     injury rates will be higher in indoor soccer compared to outdoor soccer.   "
112222|NCT01817036|"     To determine the dose-response between the doses of vitamin D3 supplements and raised serum     levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥     75 nmol/L;   "
112223|NCT01817023|"     The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT)     alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally     advanced nasopharyngeal carcinoma.   "
112224|NCT01817010|"     To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation     program (CMC) have better strength and functional performance compared to a control group     (CON).      The investigators hypothesize that functional performance and strength in the muscles     surrounding the hip and the knee will be greater in the multi-component rehabilitation group     compared to the control group.   "
112225|NCT01816997|"     Evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems     to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired     fasting glucose.   "
112661|NCT01811290|"     The purpose of this study is to assess whether Multiple Sclerosis patients treated with     Gilenya show a beneficial change over time in bone mass density and bone turnover markers as     compared to matched controls treated with alternative FDA approved therapy or no therapy.   "
112227|NCT01816971|"     This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and     after stem cell transplant works in treating patients with newly diagnosed multiple myeloma.     Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in     different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing     the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and     dexamethasone before and after stem cell transplant may kill more cancer cells   "
112228|NCT01816958|"     application of external neuromodulation along with ketamine infusion.   "
112229|NCT01816945|"     The investigators' mobile application-based community, termed Momba, will provide a     bi-directional flow of information on maternal and infant mental health to traditionally     underrepresented groups of mothers and their infants. The overall goal of this mobile     application-based community of low-income postpartum women and infants is to increase the     social support, social networks, and social capital of low-income mothers; thereby, leading     to a positive change in the health behaviors, utilization of health services, and mental     health status of both mothers and their infants.   "
112230|NCT01816932|"     This is a pilot study in which women who desire an etonogestrel implant will be randomized to     either a home or office insertion visit. The purpose of this research is to study the     interest in, feasibility of, and rates of insertion for implantable birth control     (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office     visit appointments.      The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant     and increase consistent and correct contraception use by introducing a previously unexplored     method of access, the home visit.   "
112231|NCT01816919|"     Head and neck tumors are common in the general population especially in high risk groups of     smokers and alcohol abusers, as well as after exposure to various environmental factors.     Diagnosis is based on identification of patients gross disease after a physical examination     and various imaging methods, and characterization of tissue mainly by fine-needle puncture     (FNA) and biopsy. Determining the stage of disease is based on physical examination, imaging     and tissue samples.      Using the electronic nose technology we hope to identify microscopic disease when it is     suspected or in populations in risk, thus diagnose patients in the initial stages of the     disease. Obviously, early diagnosis and treatment decisions will hopefully improve the     prognosis.      Finding a positive correlation between the stages, levels and various tumor volume and     respiratory specimens findings will classify patients more accurately and contribute to     further characterization of the disease in a more accurate, rapid and non-invasive fashion.   "
112232|NCT01816906|"     This particular trial is looking to compare the effectiveness of two types of foot bed/ sole     materials used within diabetic footwear.   "
112233|NCT01816893|"     The goals of this proposal are to determine the effects of hypoglycemia on the autonomic     nervous system and whether administration of a mineralocorticoid receptor antagonist modifies     the effects of hypoglycemia on the autonomic nervous system   "
112234|NCT01816880|"     The aim of this sub-study is to determine whether healthy individuals over 90 years of age     possess immune cells that are involved in protection from chronic disease. The immune system     is well known to produce anti-cancer and other immune cells, called antibodies that can be     beneficial to our health. In this study the investigators will evaluate the immune status of     the healthy individuals over 90 years of age. The investigators will be focused on studying     molecules known to be involved in cholesterol, cancer like those for prostate cancer and     breast cancer, inflammatory diseases, and infectious diseases like influenza.   "
112238|NCT01816828|"     Gay Poz Sex (GPS) is a peer-facilitated holistic sexual health program for gay and bisexual     HIV-positive men. Groups of five to eight men attend eight weekly sessions which cover basic     sexual health information, review the current legal context surrounding HIV non-disclosure     and use motivational interviewing (MI) to support participants in setting and achieving     personal goals.      In this randomized control trial phase of the research, the investigators are assessing the     efficacy of the group counseling intervention, GPS. Participants are randomized to receive     GPS immediately or to a wait list/standard of care condition. Participants are followed for a     6 month period and are asked to complete baseline quantitative assessments, as well as two     qualitative interviews.   "
112239|NCT01816815|"     Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian     function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD     (pharmacokinetic/pharmacodynamic) relationship   "
112240|NCT01816802|"     The purpose of this study is to record and evaluate the use of traditional morphology grading     combined with Eeva in the treatment of in vitro fertilization.   "
112241|NCT01816789|"     This randomized controlled trial has been designed for carrying out a comparison of new AMH     (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide     accepted age-based strategy. The main objective of the trial is to assess whether an     individualized FSH starting dose can increase the rate of women with an adequate ovarian     response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).   "
112242|NCT01816776|"     The primary purpose of this prospective, multicenter, randomized trial is to evaluate the     safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate     to severe central sleep apnea and optimal medical management, compared to outcomes in     randomized control subjects receiving optimal medical management and implanted but inactive     remedē® systems.   "
112252|NCT01816646|"     The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose     directly into the bladder is absorbed by the body. Researchers also want to measure the     amount of study drug in the body at different time points. The safety and tolerability of     this drug will also be studied.      Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing.   "
112253|NCT01816633|"     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a     prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will     be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving     undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research     Network (USWRRN) centers.   "
112243|NCT01816763|"     In light of the importance of pain and widespread interest in patient-centeredness, the     Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its     management a routine feature of the health record and a focus of care. Awareness of pain and     efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice     of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10     Numeric Rating Scale (NRS).      The team's previous research on VA's '5th Vital Sign' informs the specific design of this     Effective Screening for Pain (ESP) study as well as the proposed research products.      Alternatives to the current pain screening approach may improve the sensitivity and     specificity of screening for chronic pain. These alternatives include the nurse administered     NRS with a one week look back period and a three item scale (PEG) incorporating intensity and     emotional and physical interference. The PEG is very similar to the gold standard Brief Pain     Inventory (BPI) from which it is derived, in its sensitivity, specificity, and sensitivity to     change in detecting clinically important, functionally impairing pain.      The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain     screening, focusing on simple, feasible measures that can be used cross-sectionally for pain     screening. In the setting of a primary care clinic, the investigators plan to     cross-sectionally evaluate three arms - a nurse documented NRS now, a tablet computer-based     NRS one week, and a tablet computer-based PEG.   "
112244|NCT01816750|"     The recently introduced Computed tomography (CT) scanner, Discovery CT750 HD (GE Healthcare,     Milwaukee), incorporates a battery of innovations aimed at improving diagnostic image     quality, evaluating perfusion and assessing for scar, in an effort to address the current     shortcomings of Computed tomographic coronary angiography (CTCA) in patients with significant     coronary artery disease. The new scanner will use a novel method of scanning (Cardiac     Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical     Iterative Reconstruction- ASIR) as opposed to standard definition 64-slice CT Multi-detector     row computed tomography(MDCT)and Filtered Back Projection (FBP) used by the conventional CT     scanners. The Cardiac GSI protocol enables the scanner to acquire images at two different     x-ray energies almost simultaneously, which can be post-processed to selectively reduce beam     hardening artefacts and delete materials with specific attenuating properties from the     images, such as coronary calcium. ASIR offsets the potential increase in radiation dose     required for Cardiac GSI scanning. This will potentially result in images of higher     diagnostic quality with an equivalent or perhaps lower dose of radiation compared to present     technology.      Furthermore, it is hypothesised that dual-energy acquisition may improve the accuracy of the     assessment of perfusion.      Although initial in-vitro results are encouraging, this technology has not been rigorously     assessed with regards to its feasibility and diagnostic quality, limiting its applicability     in routine clinical practice. This assessment will require a trial comparing the accuracy of     Cardiac GSI CTCA with that of Invasive coronary angiography (ICA) for anatomical assessment     of stenosis, Myocardial Perfusion Imaging with Single Photon Emission Computed Tomography     (MPI-SPECT) for assessment of perfusion and Cardiac Magnetic Resonance (CMR) for assessment     of myocardial scar. We have designed a pilot study in this regard which will help us assess     the feasibility of the scan protocol and provide data to power a larger study to assess the     diagnostic remit of Cardiac GSI scanning in the assessment of patients with high-risk of     significant coronary artery disease and myocardial scar.   "
112245|NCT01816737|"     Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure     induced by te abdominal ultrasound transducer. The investigators would like to study the     response of flow in main fetal vessels to different, mild to moderate pressures induced by     the abdominal transducer. The pressure induced by the transducer will be measured by a     digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound     Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each     pregnant woman. Ones without applying transducer pressure (control) and ones after applying     mild pressure.   "
112246|NCT01816724|"     The objective of this study is to validate the spanish (from Spain) version of the Nocturia     Quality of Life Questionnaire and assess their psychometric properties, using the spanish     translation provided by the copyright holder.      Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by     Intraclass Correlation Coefficient), Convergent Validity (assessed using other already     validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health     and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be     evaluated.   "
112247|NCT01816711|"     The purpose of this study is to assess whether all frail elderly admitted with hip fracture     has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in     frail elderly.      Frail elderly are defined as being 65 years of age or older, and living in nursing homes or     senior housings.      The investigators' hypotheses state that:        1. Frail elderly with hip fractures will have a suboptimal level of vitamin D.        2. Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin D          than frail elderly without any hip fractures during the last ten years.   "
112248|NCT01816698|"     Prehypertension are associated with an increased risk of atherosclerosis and coronary artery     disease, and often complicated with the metabolic disorder of glucose and lipid. The     comprehensive prevention of hypertension is still an important and complex clinical issue.     Taurine is one of the ingredients of Chinese medicine bezoar ,as an endogenous amino acids is     central inhibitory neurotransmitter, can regulate the excitability of nerve tissue, regulate     body temperature, therefore, antipyretic, sedative, analgesic, anti-inflammatory,the role of     anti-rheumatic, anti-convulsant. In addition, Taurine inhibits platelet aggregation in the     circulatory system, lower blood lipids, to maintain the body's normal blood pressure and     prevent atherosclerosis; protective effect on myocardial cells, can be anti-arrhythmic;     special efficacy to lower blood cholesterol, to treat heart failure. The effect of oral     Taurine on blood pressure is not consistent, however, many animal study has shown that oral     administration of Taurine, could reduce 24-hour mean arterial systolic and diastolic blood     pressure in spontaneous hypertensive rats. Furthermore, Taurine interfere with calcium and     low affinity binding of the calcium binding sites, decrease the voltage-dependent Ca2+channel     in vascular smooth muscle relaxation, vasodilation, lower blood pressure.In a prospective,     double-blind, randomized, and parallel-group study, we will evaluate the effects of Taurine     granule on blood pressure and metabolic parameters in prehypertensive and mild hypertensive     patients. This study will help develop future comprehensive prevention and treatment     strategies for hypertension.   "
112249|NCT01816685|"     Patients with a medical condition known as obstructive sleep apnea may be at increased risk     of delirium following surgery. This study loans autotitrating CPAP machines to     randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of     preventing post-operative delirium.   "
112250|NCT01816672|"     The purpose of this study is to determine if AutoloGel platelet rich plasma used on non     healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and     customary care   "
112257|NCT01816581|"     Postoperative pain and analgesic treatment still remains a challenge in daily perioperative     medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal     cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for     postoperative pain. Poorly controlled pain can contribute directly or indirectly to     postoperative complications, such as myocardial ischemia, pulmonary dysfunction like     hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and     decreased mobility. In addition, prolonged acute pain also results in chronic pain.      Opioids are internationally recognized as the golden standard in the treatment of acute     postoperative pain. On one side, the high potency of opioids in pain relief is clearly     undisputed, but on the other hand, the administration of opioids is associated with nausea,     vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms     including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is     a frequently reported adverse effect and sometimes requires discontinuation of therapy, which     results in analgesic under-treatment, severely impairing quality of life. However, there are     many different regimes for the treatment of postoperative pain using opioids.     Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff     and expensive equipment. Once patients are able to tolerate oral medications, the oral route     is preferred postoperatively because it is more convenient, noninvasive and less expensive.   "
112258|NCT01816568|"     Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery     with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3     ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital     stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was     developed with the aim of reducing the invasiveness of conventional laparoscopy. In this     study the investigators aimed to compare results of SILS appendectomy and three port     conventional laparoscopic appendectomy prospectively.   "
112273|NCT01816373|"     The purpose of this study is to determine whether the non-invasive negative pressure     treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum     treatment   "
112274|NCT01816360|"     The purpose of this study is to verify and analyse psychological and physiological effects of     olfactory aromatherapy and yogatherapy respiratory exercises, together and separately, on the     quality of life, levels of stress, quality of sleep and intensity and frequence of hot     flashes in climacteric women.   "
112259|NCT01816555|"     This study is for adult females who have been newly diagnosed with breast cancer that     includes surgery as part of standard cancer treatment. This is a research study combining     Vitamin D (an over the counter medication) with the standard of care (or the established and     approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a     higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to     find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer.     Screening tests will be done to determine if subjects are eligible to participate in this     study. If subjects are eligible and they agree to participate, they will be assigned to one     of two groups which will receive different amounts of vitamin D. Subjects will be asked to     keep a medication diary. Subjects may remain on treatment for approximately 56 days.   "
112260|NCT01816542|"     The purpose of the study is to determine if any of Mother's Choice' all-natural personal-care     products cause either irritation or allergic reaction when applied to both normal or     sensitive skin.      Each product will be tested on the skin using patch tests.   "
112261|NCT01816529|"     The goal of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream     to induce sensitization by repeated topical application to the skin of healthy subjects under     controlled conditions.   "
112262|NCT01816516|"     Poor feeding practices during infancy contribute to obesity risk because they interfere with     infant feeding self-regulation and appropriate growth patterns as infants transition from     human milk and/or formula-based diets to solid foods. The goal of the project is to provide     an educational intervention that fosters appropriate maternal responsiveness, feeding styles,     and feeding practices via infant-centered feeding.   "
112263|NCT01816503|"     The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring     satisfaction with pain treatment after administering fentanyl matrix in patients whose pain     was not controlled sufficiently with the previous analgesic use in real practice at the     investigator's discretion.   "
112264|NCT01816490|"     Chronic hepatitis C virus (HCV) is a major cause of morbidity and mortality worldwide with an     estimated number of 180 million infected patients. Until 2012 the current standard of care     (SOC) treatment of patients with chronic hepatitis C was a 24 to 72 weeks therapy with     pegylated interferon- and ribavirin (PR). In 2012, the protease-inhibitors (PI's) telaprevir     and boceprevir as first directly acting HCV drugs have been approved by the local Swiss     authority for hepatitis C mono-infected and HCV-HIV-co-infected individuals. However, therapy     success is strongly limited in null-responders (NR) to previous PR. Treatment of HCV-HIV     co-infected individuals with the new PI's is accompanied by additional challenges (e.g.     drug-drug interactions, toxicity, high pill burden). Patients with advanced fibrosis are at     highest risk for decompensated liver disease and hepatocellular carcinoma (HCC) and prompt     initiation of treatment is strongly recommended. Recently, data in mono-infected patients     showed, that in prior non responders a 12 week course of a triple therapy (TT) with     telaprevir and PR followed by another 24 weeks of PR resulted in an sustained virologic     response (SVR) of only 29%. In HCV-HIV co-infected non-responders with unfavourable     preconditions (e.g. HCV-genotype 1, interleukin 28 B non-CC genotype, advanced liver     fibrosis, high baseline HCV viral load) SVR after TT is even expected to be lower. These     patients urgently need additional therapeutic options with the goal to eradicate HCV in order     to prevent further fibrosis progression and to reduce morbidity and mortality. A promising     substance in the field of drugs targeting the HCV replication is silibinin. Silibinin is the     main component of silymarin, an extract of the milk thistle Silybum marianum. Intravenous     silibinin (iSIL) targets multiple steps in the virus life cycle and exhibits anti-oxidant,     anti-inflammatory, anti-viral and immunomodulatory properties. iSIL inhibits the HCV NS5B     polymerase activity directly or by interfering with the binding of RNA to this enzyme. In     addition, iSIL appears to block virus entry, virus transmission and virus secretion.In 2008     Ferenci et al. for the first time reported the substantial clinical antiviral-effect of     intravenous silibinin (iSIL) against HCV in PR non-responders. The administration of 20mg/kg     iSIL in 20 patients led to a highly significant decrease in viral load. We intend to     investigate the effect and tolerability of iSIL in HIV-HCV co-infected individuals with     advanced liver fibrosis and previous non- or partial response to SOC. All included     study-subjects will receive a lead-in therapy with iSIL in a dosage of 20mg/kg/day (expressed     as silibinin concentration) once a day for 14 days. At the end of the THISTLE study, i.e.     after the day of completion of the 14-day iSIL administration (day 15), the patients will be     considered for eligibility to receive standard of care. We assume that the decline in HCV     viral load would substantially improve the chances of SVR as the reduction of viral load     should both increase the efficacy of PR and reduce the odds of drug resistance to     HCV-specific protease inhibitor.        -  Trial with medicinal product   "
112265|NCT01816477|"     Pectus excavatum (PE) is a common chest wall deformity where the sternum is displaced     posteriorly. In severe cases, surgery is performed to correct the defect. In recent years,     minimally invasive surgery with the placement of stainless steel support bars has been     increasingly performed in patients over the age of 17 years. Because of the decreased     malleability and tremendous pressure required to hold the chest wall in the corrected     position, post-operative pain control has been a significant problem in this patient     population. Thoracic epidurals are commonly employed however mean hospitalizations of up to 7     days have been required before adequate pain control on oral analgesics is obtained and     patients are suitable for discharge.      It is hypothesized that using the ON-Q system (I-Flow Corporation, Lake Forest CA) with     bilateral intercostal catheter infusion would provide adequate post operative pain control     with a significantly shorter hospital length-of-stay than thoracic epidural. Total use of     narcotics for 1 week following surgery would also be less with the ON-Q system versus     epidural.   "
112266|NCT01816464|"     The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in     HIV-uninfected pregnant women compared with HIV-uninfected non-pregnant women in 2013. Safety     data will also be collected.THe Pregnancy outcomes and the transplacental transfer of     antibodies will also be assessed.   "
112267|NCT01816451|"     The purpose of this study was to verify physiological responses to constant-load (continuous)     vs. variable-intensity (interval) during 14 weeks of aerobic exercise on active men. The     hypothesis was that would be differences in physiological variables on distinct modes of     execution performed on the treadmill over a period of 14 weeks of training.   "
112811|NCT01809314|"     This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon)     in participants with symptomatic anemia and cancer receiving chemotherapy. Participants     receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics     will be followed for 4 months.   "
112268|NCT01816438|"     The main purpose is to describe clinical practices nowadays prospectively about patients with     a dysplasia diagnosis or another histological lesions.      It will be identified colic situation during the initial colonoscopy after dysplasia     diagnosis or atypical lesion.      Also the frequency and the type of monitoring conducted about these patients(surgical and     endoscopic treatments).      The main criterion evaluation will be the surgical and endoscopic rates during the time.      The treatments offered such as surgical, endoscopic ones or none of them will be followed.      Finally, the outcome of these patients: stability, lesion disappearance, surgery or     development of cancer with frequencies for each of them and relationships with histological     abnormal colorectal lesion will be measured.   "
112269|NCT01816425|"     The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects     biomechanical principles, providing harmony between mechanical and biological activities. The     fundamental principles of biomechanics applied in the manufacture of steel structure are:     retention, reciprocity, attachment and stability. To get the proper planning, we need to     assess the dental support system, with its qualitative and quantitative values. But     conventional dentures has a inherent problem which is the metallic elements apparent and in     some cases the stiffness of the component support elements that generates stress.      The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in     oral rehabilitation. So many treatments are being done in everyday practice without a defined     concept on various aspects of its construction and oral applicability.      This trial aims to assess the basic parameters of both dentures in: nutrition, speech     therapy, chewing force, chewing efficiency and quality of life.      60 years old or older patients who require removable prosthesis. These will be randomly     selected for the fabrication and installation of removable partial dentures (Gold Standard -     control group - CoCr partial denture) and thermoplastic partial denture(experimental group).      Before beginning the work, selected patients will make some preliminary tests such as     controlling the individual condition, they are:        -  three questionnaires:        -  instrument for assessing quality of life related to oral health, GOHAI - General Oral          Health Assessment Index of Atchinson & Dolan        -  instrument for assessing the social and economic profile of ABEP (Brazilian Association          of Research Companies) CCEB 2011;        -  Instrument for assessing cognitive condition MINI-MENTAL;        -  Speech evaluation        -  Nutritional assessment;        -  Evaluation of masticatory efficiency and        -  Chewing strength. After preliminary assessments patients will be subjected to treatments          for manufacture of partial dentures. After the installation (end of the technical          construction of the dentures) and the adjustments appointment the tests will be repeated          and in successive control periods of 3 months, 6 months, 12 months, 18 months and 24          months respectively, when the tests will do again now to see if there was a change in          the initial condition.   "
112270|NCT01816412|"     To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of     the femoral and popliteal arteries in the Japanese population.   "
112271|NCT01816399|"     The aim of this study is to determine whether a new vectorcardiogram (VCG) analysis will     facilitate the detection of significant coronary disease (CAD) in patients with normal rest     12-leads ECG (NE).   "
112272|NCT01816386|"     In the present study, the investigators want to evaluate if press needle acupuncture applied     prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve     fast-track anaesthesia in the PACU after general surgery.   "
112275|NCT01816347|"     The cyclic movement of the heart and the coronary arteries induces relative axial movement     between the artery and a pre-deployed intra-luminal stent which may cause malpositioning.     Using a new imaging algorithm to indicate the position of a stent in patients undergoing     percutaneous coronary intervention (PCI), the investigators will measure the pre-deployment     relative, intra-luminal stent axial movement in the different coronary arteries to facilitate     the precise deployment site.   "
112276|NCT01816334|"     The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids     are effective in the treatment of acute sciatica   "
112277|NCT01816321|"     In combination with the existing literature, previous work indicates that 1) women with poor     ovarian response fulfilling the Bologna criteria have very low pregnancy rates,     irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that     do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing     pregnancy rates in young patients (<40years old) fulfilling the criteria. These findings     provide a strong rationale for a definitive large RCT. The COMPORT study will provide     conclusive evidence regarding the superiority or not of this novel protocol with     corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders     fulfilling the Bologna criteria.   "
112278|NCT01816308|"     This study aims to compare the incidence of new-onset cognitive impairments and change in     existing impairment status between AF patients undergoing either catheter ablation or     remaining on anti-arrhythmic drugs (AAD) as assessed by Montreal Cognitive Assessment (MoCA).   "
112279|NCT01816295|"     The main purpose of this study is to evaluate if testosterone solution can raise testosterone     hormone levels into the normal range, and also improve levels of sexual arousal, interest and     drive and/or energy level, in men with low testosterone and decreased sexual arousal,     interest and drive and/or decreased energy. The study will last about 16 weeks, followed by     an optional 24 week open label treatment phase to investigate the long term safety of     testosterone solution.   "
112280|NCT01816282|"     A randomized controlled study is performed to address the question of whether the topical     application of a novel fibrin sealant, Evicel (Johnson & Johnson Wound Management, Ethicon,     Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative     blood loss and the need for allogenic blood transfusion compared to a control group. We     hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after     total knee replacement.   "
112281|NCT01816269|"     Patients who had received H.pylori eradication treatment will be categorised as eradication     and reinfection status and whether dental scaling has any influence on these results.   "
112282|NCT01816256|"     This study involves screening for portal vein thrombosis and portal hypertension in patients     with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia     vera (PV), essential thrombocythemia (ET), and myelofibrosis.      Portal vein thrombosis and portal hypertension are serious complications that are often seen     in myeloproliferative patients. These complications are usually diagnosed when patients     become symptomatic, and are often already at an advanced stage. They can further progress to     cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of     this, patients often accumulate fluid in the abdomen which is ascites; and can develop     swelling of veins in the lining of the esophagus known as varices. If untreated, varices have     the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced     stage, the treatment is usually supportive therapy and there are no treatments available at     present which can reverse these conditions.      This study is looking at screening for these two conditions using Doppler ultrasound and     upper gastrointestinal endoscopy.   "
112285|NCT01816217|"     Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New     videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed     to compare a new videolaryngoscope called  McGrath Mac Video Laryngoscope vs standard     Macintosh Laryngoscope in critically ill patients on difficult intubation and/or Cormack 3-4     rates in a prospective interventional study.The present study was conducted to test the     hypothesis that the implementation of a quality-improvement process for airway management     using a new videolaryngoscope would be associated with a decreased incidence of difficult     intubation and/or Cormack 3-4.   "
112286|NCT01816204|"     Therapist assisted, internet-based cognitive behavioral therapy (TAI-CBT) has been shown to     be effective with patients who have Generalized Anxiety Disorder (GAD) in multiple studies     from several countries, including: the United Kingdom, Australia, Sweden, and the     Netherlands. Despite strong evidence of efficacy, TAI-CBT has not been offered in the USA.     TAI-CBT could provide an effective alternative to face-to-face psychotherapy that would     expand the availability and convenience of evidence- based treatment anywhere clinical     availability is limited. The University of Florida (UF) has historically had greater demand     for psychotherapy than the available supply of psychotherapy hours resulting in waiting lists     for students needing to receive treatment for anxiety. Anxiety disorders interfere with     memory and concentration thus impairing academic functioning. Students who must wait for     treatment for 3-4 weeks are at risk for failing courses or dropping out of school. If TAI-CBT     proved to be effective with UF students, providing it could increase the number of students     who would receive effective and timely treatment. This project will create a 6-8 session     therapist assisted on-line treatment for anxiety disorder. The investigators will offer     TAI-CBT as an experimental treatment in summer and fall, 2013 comparing outcomes to     face-to-face individual therapy, group therapy, and wait-list controls. The investigators     hypothesize that students receiving TAI-CBT will have a reduction in anxiety symptoms     comparable to face-to-face counseling and greater than wait list controls.   "
112289|NCT01816165|"     Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk     in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to     IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated     fatty acid lowering with acipimox will improve insulin action and blood vessel function and     have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial     function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D     treatment that may significantly improve current management of TID and of cardiovascular     disease (CVD) risk in this high risk population.   "
112290|NCT01816152|"     Tailored light treatment will increase sleep efficiency, reduce depression and reduce     agitation scores in those with Alzheimer's disease and related dementia   "
112291|NCT01816139|"     The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal     gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as     measured by self-assessment, vaginal pH and vaginal smear.   "
112292|NCT01816126|"     Colonoscopy can be performed by a one-operator technique with endoscopist personally     advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant     doing the physical insertion and withdrawal of the scope directed by the endoscopist.     Uncontrolled data report that 1 operator technique is associated with a higher adenoma     detection rate, although it is also characterized by a lowwer cecal intubation rate and     longer intubation time. The aim of present randomized controlled study was to assess whether     one technique is better than the other one in terms of colonoscopy quality performances.   "
112293|NCT01816113|"     This is an open label phase Ia study, to assess the safety of two novel malaria vaccines,     ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our     knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can     importantly also induce antibodies. Previous clinical trials using this regimen expressing     ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later     by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide     comparability with previous ChAd63-MVA trials, we propose to use a similar administration     schedule.   "
112294|NCT01816100|"     This study is a unique blend of new technologies never used in combination with individuals     diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in     brain activity, functional brain activation and diffusion in the brain following 6 months of     structured weight resistance and balance training. Positive changes would indicate that the     therapy has ignited brain plasticity and may drive the brain to repair itself. These changes     to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and slowing     of neural degeneration. No other trials have been published evaluating brain plasticity     utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in subjects with MS     undergoing physical training. DTI has demonstrated the ability to find changes (plasticity)     that occur in the brain and using the MEG findings to focus the DTI analysis will optimize     the capacity to detect changes secondary to therapy. This quantification will give a better     understanding of the repair that goes on in the brain, and may potentially revolutionize the     field of the central nervous system (CNS) rehabilitation. One of the most innovative aspects     of this study is the full integration of clinical neurobehavioral metrics and functional     imaging data in conjunction with a proven MS therapy along with quality of life indicators.     This approach will allow new links to be illuminated as the trajectories of functional and     structural brain changes (neuroplasticity) are meshed with clinical improvement indices     collected visit-by-visit. This study will also compare disease modifying treatments (DMTs)     and their effect(s) on indices of brain plasticity and cognitive and behavioral assessments.   "
112295|NCT01816087|"     The AGE (Active Geriatric Evaluation) aims to develop a brief assessment tool adapted to the     primary care setting.   "
112296|NCT01816074|"     We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder     (ADHD) will have a beneficial effect that extends to the child. We believe that     multi-component interventions combining maternal stimulant medication, Lisdexamfetamine     (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child     outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well     to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may     benefit most from multi-modal treatment   "
112299|NCT01816035|"     This phase I trial studies the side effects and best way of giving trastuzumab emtansine in     treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer     that has spread to other parts of the body or nearby tissue and cannot be removed by surgery.     Biological therapies, such as trastuzumab emtansine, may stimulate the immune system in     different ways and stop cancer cells from growing.   "
112300|NCT01816022|"     This is a clinical study to evaluate the effect of CMPN (Chronic myeloproliferative neoplasm)     to the bone.      The hypothesis is that patients with CMPN have a higher fracture-rate compared to the     background population. We expect to find a lower BMD using conventional DXA scan (dual energy     x-ray absorptiometry), and a change in other parameters using HR-pQCT (high-resolution     peripheral quantitative computerized tomography).Biochemical bone markers is measured to     support the hypothesis.   "
112301|NCT01816009|"     The study is a prospective, open randomized, non-inferiority trial with two parallel groups,     comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure     (debridement and retention, 1-stage or 2 stage exchange).      The duration of the treatment antibiotic of prosthetic joint infections is only based on     experts' opinion ; this one varies from 6 weeks to several months according to the customs of     the influencer.      The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12     weeks antibiotic therapy duration, both associated with surgical procedure (debridement and     retention of implant, one-stage or two stages exchange), in PJI treatment.      The study concerns 410 men or women of more than 18 years include in 34 centres in France.      The duration of the study is of 4 years.   "
112302|NCT01815996|"     The investigators are developing a test that is expected to measure the amount of radiation a     patient has been exposed to after a nuclear bomb. The investigator will do this by measuring     the DNA in the patients blood from cells killed by the radiation.      Many diseases and medical conditions can put DNA in the blood. The investigator needs to know     how much DNA in order to better interpret our radiation detection test. Therefore, the     investigator is collecting blood from several patients with different diseases or medical     conditions and also healthy volunteers to measure their DNA content.      Patients that will be included in this study are pregnant women, patients who have suffered a     pulmonary embolism within the past 48 hours, patients who have suffered from myocardial     infarction in the past 48 hours, patients with autoimmune diseases and health patients.   "
112303|NCT01815983|"     This study is designed to evaluate the impact of a video recording review on the acquisition     of a new technical skill (laryngoscopy and tracheal intubation).   "
112304|NCT01815970|"     Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death world-wide.     Dyspnea (i.e., sensations of breathlessness) is the hallmark symptom of patients with this     disease. Pulmonary rehabilitation programs that incorporate exercise training remain the most     effective non-pharmacological method of reducing dyspnea in COPD, however it is not     understood how exercise training relieves dyspnea. Accordingly, the purpose of this study is     to determine if pulmonary rehabilitation can reduce the disparity between the drive to     breathe and the breathing response in patients with COPD and to determine if this reduction     is associated with improvements in dyspnea during exercise.      The investigators hypothesise pulmonary rehabilitation will reduce dyspnea at a standardized     work rate and this reduction will be directly related to an improvement in the breathing     response.   "
112305|NCT01815957|"     This study is being done to determine if Ranolazine treatment improves coronary     microcirculation function among patients with coronary microcirculation dysfunction. We are     also looking to learn if symptomatic improvement of chest pain during treatment with     Ranalozine is related to improved coronary microcirculation function.   "
112306|NCT01815944|"     Regional anesthesia employs the use of local anesthetics (LA) to block specific nerves to     enable pain free surgery to be performed, or for intra and post operative pain relief.     Dilution of local anesthetics with normal saline (NS) is a common practice to enable larger     volumes of LA to be given, for example, in instances where multiple nerve blocks are needed     to be performed for optimal pain relief while avoiding toxic doses.      A high sodium concentration is known to antagonize the analgesic effect of local anesthetics.     5% dextrose (D5W) on the other hand is painless on injection and does not cause any long-term     effects in animals or humans when injected around neurological tissue. In the literature,     only one study using dextrose 5% as diluent to produce 0.5% ropivacaine for axillary brachial     plexus block showed a statistically significant reduction in the onset time for sensory     blockade when compared with dilution with NS.      In this study, 0.5% ropivacaine diluted with D5W or NS is used for ultrasound guided     supraclavicular brachial plexus block, and the time for complete sensory and motor blockade     was compared. 0.5% ropivacaine is easily diluted and is a common concentration used at our     centre for nerve blocks. The aim of this study is to assess if 0.5% ropivacaine diluted with     D5W results in a shorter onset time for sensory block which may change the current practice     of dilution with NS   "
112307|NCT01815931|"     In this study, we aim to identify risk factors for hemolysis in blood samples drawn in the     ED.   "
112308|NCT01815918|"     One postoperative complication following unilateral or bilateral total knee arthroplasty is     thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled     clinical trial, researchers are investigating the effect of steroids on biochemical markers     of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have     been linked to postoperative depression following total knee arthroplasty surgery. Hence the     investigators are also checking if use of hydrocortisone, a steroid, may help reduce the     incidence of postoperative depression.      Other studies have shown that surgery causes some reaction in the body that is consistent     with inflammation. When the inflammation is extensive, it may affect different parts of the     body. It may also lead to clotting disorders and result in blood clots. In a previous study     by this principal investigator (see reference 22, Use of low-dose steroids in decreasing     cytokine release during bilateral total knee arthroplasty), hydrocortisone was administered     over 24 hours following surgery to patients who underwent bilateral total knee arthroplasty.     The investigator found lower levels of cellular markers consistent with inflammation     (specifically the protein, IL-6). Steroid use also showed additional benefits, such as     decreased pain and better range of motion at the knee.      In this study, investigators recruit patients undergoing total knee arthroplasty surgery.     Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a     saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect     on clotting factors (i.e. IL-6), investigators record patients' pain scores and patients'     oral analgesic use. To assess patients' well-being, patients are contacted one month and 3     months following their surgeries and administered the Patient Health Questionnaire (see     reference 23, The PHQ-9: validity of a brief depression severity measure.) arthroplasty.   "
112309|NCT01815905|"     Provides mobile programs for occupational and speech therapy to patients with stroke.   "
146467|NCT01367158|"     This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a     meningococcal vaccine formulation in adolescents.   "
112310|NCT01815892|"     Patients often begin dialysis taking diuretics (stimulate the kidney to excrete salt and     water). Once on dialysis, these drugs are often continued. Whether these drugs are still     needed, or even effective is often unclear.This study,by evaluating the composition of the     patients' urine when off the drug, will predict which patients should benefit from the drug.     By comparing their 24 hour volume both off and on the drug, the impact of the drug will be     established. The results will allow the prediction of which patients, in the future, should     take the drug. The hypothesis is: Among dialysis recipients, evaluation of the random urine     sodium concentration will help predict the likelihood of a positive response to Furosemide,     as manifested by an increased urine volume and sodium excretion.   "
112311|NCT01815879|"     Investigator initiated multi-institutional retrospective review of clinical and radiographic     outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver     metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks     follow up.   "
112312|NCT01815866|"     Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and     water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency.     They have been demonstrated to cause clinically significant lung disease in some cases and     the transmission of NTM, from person to person has been proposed. There are currently no     standardized guidelines for isolation of those colonized or infected with NTM.      The investigators will measure particle droplet size from patients with CF who have positive     sputum cultures for NTM with the hypothesis that they will be in a range that can spread     infection.   "
112313|NCT01815853|"     Background: It has been shown that the patitents with gastric cancer could benefits from     peri-operative chemoradiotherapy, but whether the pre-operative chemoradiotherapy can improve     patitents' outcome is still unclear.      Patients and methods: In this study , patients with histologically confirmed gastric cancer     whose pre-operative staging are cT4 any N,MO, aged from 18 to 70 years and with Eastern     Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized     1:1 to receive pre-operative chemoradiotherapy with DT45Gy/25f plus two cycles of     XELOX(Xeloda 1000mg/m2, BID, DI-D14; Oxaliplatin 130mg/m2 on day 1;,21-days per cycle) or     chemotherapy alone then following by surgical resection and adjuvant chemotherapy with XELOX     at the same dose up to 4 cycles. The primary end point is overall survival (OS), and     secondary end point is disease free survival(DFS) and safety. Final study analysis will be     conducted in the end of the 5th year after the last patient's enrollment.   "
112314|NCT01815840|"     This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess     the efficacy and safety of two different vismodegib regimens in participants with multiple     basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in     an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24     weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks     vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.   "
112315|NCT01815827|"     This open-label, parallel group study will evaluate the safety, tolerability,     pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy     volunteers compared to Caucasian healthy volunteers. Subjects will receive a single     intravenous dose of inclacumab. Follow-up will be for up to 197 days.   "
112316|NCT01815814|"     The investigators hypothesize that children with spastic cerebral palsy will show greater     improvements in gross motor function, associated developmental skills and growth after the 3     months of myofascial structural integration treatment, a form of deep massage, than they     showed after a 3- or 6-month pre-treatment waiting period.      The investigators further hypothesize that children with spastic CP will maintain their gains     in gross motor function for ≥ 3 months after completion of MSI treatment.   "
112317|NCT01815801|"     The purpose of this study is to determine whether mechanical ventilation influences the     incidence of pneumothorax after subclavian venous catheterization.   "
112318|NCT01815788|"     A personal sound amplifying device (PASP) like Teo First is a wearable electronic product     that is not intended to compensate for impaired hearing, but rather is intended for     non-hearing impaired consumers to amplify sounds in the environment for a number of reasons,     such as for recreational activities. Nevertheless, a lot of mild and moderate impaired     hearing people don't want to buy and wear all day a real hearing aid.      The goal of our study is to evaluate the benefit of such a device for mild and moderate     presbycusis patient 60 years of age and older, with no previous hearing aid.   "
112319|NCT01815775|"     The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for     patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the     depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery.     The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of     predictive value of surgery response.      In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive     examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th     ventricle levels.   "
112320|NCT01815762|"     Patients will be selected from the Dialisys Centers in Iasi, Romania. Patients will be     randomized 1:1 to have a dry-weight assessment based on clinical (control) or lung US and     bioimpedance (active) guided protocol. In the control group post-dialysis dry weight will be     adjusted based on clinical criteria only (blood pressure, presence of edema, intradialytic     hypotension, cramps etc.) and in the active group the target weight will be prescribed using     lung US and bioimpedance evaluation.      In patients randomized to the active arm of the study, the US B-line score (BLS) will be     measured before dialysis and these measurements will be used to titrate ultrafiltration     prescription. In patients presenting moderate to severe lung congestion (≥15 BLS     pre-dialysis) LUS measurements will be repeated once a week until the treatment goal was     achieved (<15 BLS pre-dialysis) and once a month thereafter. The same (monthly) monitoring     frequency will be adopted also in patients without pulmonary congestion at pre-dialysis     baseline (<15 BLS). Furthermore, the use of the technique is allowed whenever its application     is deemed useful to assume clinical decisions by attending physicians. Patients in the active     arm of the study without evidence of lung congestion at baseline who developed pulmonary     congestion (≥ 15 BLS) during the trial will received the same treatment contemplated for     those with lung congestion at baseline during the trial. The treatment goal will be pursued     by ultrafiltration intensification realized within the same HD schedule (3 sessions x 4     hours/week) or, if not tolerated, by extra-dialyses, according to individual tolerance and     feasibility. In case of clinical hypovolemia (persistent cramps, hypotension etc) additional     dry-weight adjustments will be performed according to the bioimpedance measurement, provided     that the patients are below 15 BLS. This addition will be necessary in order to be able to     increase the dry-weight in patients with a persistent BLS < 15 and avoid under perfusion.      Patients in the control arm of the study will be followed up and managed strictly with     standard criteria according to current recommendations (implying optimization of fluids     volume control on the basis of clinical criteria and the use of carvedilol, ACE     inhibitors/sartans whenever deemed necessary); the use of lung US / bioimpedanc assistance     will not be messured in these patients.      The main exclusion criteria will be the presence of severe cardiac failure (NYHA class     III-IV), past myocardial infarction, stable or unstable angina and acute coronary syndrome.     Due to bioimpedance assessment limitation patients with metallic joint prostheses, cardiac     stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations will be     excluded, as BIS cannot be accurately performed in such cases. Due to lung US measurement     limitation we will exclude patients with known persistent pleurisy, pulmonary fibrosis or     pneumectomy. Other exclusion criteria will be malignancy, active infections, temporary or     permanent catheter as a vascular access, mental incompetence and unwillingness to participate     in the study.   "
112321|NCT01815749|"     This phase I trial studies the side effects and best dose of genetically modified T-cells     following peripheral blood stem cell transplant in treating patients with recurrent or     high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop     the growth of cancer cells. When the healthy stem cells from a donor are infused into the     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood     cells, and platelets. Sometimes the transplanted cells from a donor can make an immune     response against the body's normal cells. Removing the T cells from the donor cells before     transplant may stop this from happening. Giving an infusion of the donor's T cells (donor     lymphocyte infusion) later may help the patient's immune system see any remaining cancer     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor     effect)   "
112322|NCT01815736|"     This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide     (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil     fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected     participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.   "
124260|NCT01659281|"     The main purpose of this study is to compare artesunate-mefloquine combination therapy given     for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum     malaria.   "
112323|NCT01815723|"     This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group     study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared     to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial     wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study     treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily     Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks     for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate     open label treatment protocol expected to continue for up to 5 years.   "
112324|NCT01815710|"     An Ontario-wide study to identify best strategies to promote uptake of high quality, expert     developed Clinical Pathways (CPs) within Emergency Departments.      The investigators will work with 16 Community EDs across Ontario to i) tailor an     implementation strategy that works for each ED, ii) assist with the implementation of one     pediatric emergency CP (Asthma or Gastroenteritis) at each site, and iii) evaluate the impact     on health professionals, patient outcomes and economic costs. The investigators will conduct     a 3.5 - year mixed methods health services research project with four study objectives: 1) to     design a theory-based and knowledge user-informed intervention strategy to successfully     implement two provincial pediatric emergency clinical pathways into practice in community     Emergency Departments (EDs); 2) to evaluate the effectiveness of this implementation     strategy; 3) to conduct a process evaluation to assess the implementation strategy; and 4) to     conduct an economic analysis to evaluate implementation costs and benefits.   "
112325|NCT01815697|"     The purpose of this study is to access the effects of Enhanced External Counterpulsation     treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.   "
112329|NCT01815645|"     Crack addiction has become a severe health problem in Brazil. Today, crack addiction is the     primary cause for inpatient treatment for all illicit substances. When compared to cocaine,     crack users develop much faster diagnoses for crack dependence, shows a more compulsive     pattern of use, has higher probability of living or have lived in the streets, and of     engaging in illegal activities. Consequently to this, mortality of crack addicts is 7 times     higher than for the rest of the population.      Despite all efforts being made for the development of effective pharmacological treatments     for stimulant addiction (crack included), up to today, there is no robust evidence of     efficacy of any pharmacological treatment. For that reason, the use of evidence based     psychosocial interventions is so important for treating this population.      Although today open treatment facilities in Brazil are more and more starting to use     evidence-based interventions such as motivational interviewing, cognitive behavior therapy,     relapse prevention and coping skills, such treatments present very modest results when     treating crack addiction. The biggest difficulties encountered when treating this population     are maintaining patients in treatment, reducing crack use and achieving continued abstinence.      A psychosocial treatment based in behavioral principals' named Contingency Management (CM) is     widely applied in the USA. Recent meta-analyses and review studies present robust evidence     that, when applied alone or in adjunction with other psychosocial and pharmacological     treatment, CM is the most effective treatment for what regards, treatment retention, reducing     drug use and promoting continued abstinence.      The purpose of this study is to evaluate if Contingence Management (CM) can be affective in     the treatment of crack addiction in Brazil. To accomplish this, 60 individuals (male and     female from 18 to 65 years of age) seeking open treatment for crack addiction will be     randomized to 2 treatment conditions (Standard treatment (ST) or ST+CM. Both treatments will     last 12 weeks with 3 and 6-month follow-up. In both groups patients will be encourage to     leave urine samples 3 times week.      Hypotheses: Patients receiving ST+CM will stay longer in treatment, have more negative tests     for cocaine/crack, and achieve longer periods of cocaine/crack abstinence when compared to     patients receiving ST alone.   "
112330|NCT01815632|"     Multiple sclerosis - MS - affects 1.3m people worldwide, costing the European Union economy     €9 billion/year, through both direct and indirect consequences of progressive disability.     Despite the usual relapsing-remitting presentation, over 80% of patients develop progressive     disability; 40% require a wheelchair within 10 years of diagnosis. At present, there are no     treatments that reverse, halt or even slow progressive disability in MS.      The investigators recently completed one of the first feasibility/safety trials in the world     of reparative bone marrow cell therapy in 6 patients with longstanding MS     (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and     intensive repeated tests on the patients measuring nerve conduction in various pathways in     the brain and in the spinal cord showed statistically significant improvements at 12 months     in every patient. While highly preliminary and involving only a very small number of     patients, these results at least raise the possibility of a significant (though very partial)     underlying repair effect within the damaged nervous system.      The investigators believe this urgently requires further testing - both to accelerate benefit     for patients, and to begin improving therapeutic efficacy. The investigators therefore     propose a programme of translational and clinical stem cell research, aiming (1) to continue     translation with a phase two controlled trial of bone marrow cells in patients with     longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by     studying bone marrow cells from treated patients and control subjects, aiming to establish     which of the various relevant bone marrow subpopulations contribute to efficacy, and which     particular reparative mechanism(s) are important. The investigators hope these studies will     not only confirm the therapeutic benefit of this approach, but also provide the basis for     improving the magnitude and impact of this novel and exciting treatment modality.   "
112331|NCT01815619|"     This study will test two different methods for processing biopsy specimens taken from the     bile duct. Patient;s who are asked to participate int his study have a growth (mass) in the     bile duct that needs a biopsy so a diagnosis can be made. Standard of care includes     performing 5-7 biopsies in the bile duct and sending the tissue to the lab for testing to     make a diagnosis. Using this method the investigators can establish a diagnosis only about     50% of the time. The investigators believe that if a pathologist is available in the     endoscopy suite during the procedure, the investigators can improve the test results. The     purpose of this study is to compare the two methods for processing biopsies obtained from the     bile duct.   "
112332|NCT01815606|"     This study will test two different needles for performing a biopsy of the pancreas during     endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study     have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a     diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The     purpose of this study is to compare which of the two needles is better for performing     biopsies of the pancreas on masses that are greater than 35mm.   "
112333|NCT01815593|"     The purpose of this study is to investigate the efficacy of Enhanced External     Counterpulsation (EECP) in patients with erectile dysfunction   "
112335|NCT01815567|"     The purpose of this study is to study the impact of blood pressure on cognitive performance.   "
112469|NCT01813799|"     This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in     the treatment of pain associated with diabetic neuropathy. Subjects will receive either     300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain     score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and     Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.   "
112470|NCT01813786|"     Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of     scars.   "
146832|NCT01362348|"     The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a     single dose regimen of pazopanib eye drop for neovascular AMD.   "
112336|NCT01815554|"     This is an observational longitudinal study designed to identify and describe long term     outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As     this is not a randomized or experimental study, no specific hypotheses are proposed. The data     collected will enable us to answer the following research questions:        1. What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS          stimulus parameters, abandonment of DPS and related reasons).        2. What mechanical problems have DPS users encountered (system failure, repairs needed)?        3. What are the frequency of and reasons for rehospitalization following DPS implant?        4. What levels of care are needed at home to manage the DPS?        5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste,          swallowing)?   "
112337|NCT01815541|"     This is a biomedical research, prospective, mono centric, tolerance study Of the     administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.   "
112338|NCT01815528|"     Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with     recurrent ovarian cancer to investigate the feasibility and clinical activity of initial     intraperitoneal catumaxomab followed by chemotherapy regimes.   "
112339|NCT01815515|"     This research is being done to see if an investigational radioactive drug called 18F-DCFBC     can help us find cancer that has spread (metastatic disease) from its original site in people     who have cancer in their prostate to other parts of their body.   "
118153|NCT01739426|"     The primary objective of this study is to evaluation the success of endoscopic treatment of     Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of     swallowing function at 12 months post-surgery.   "
112340|NCT01815502|"     The study will investigate the cardiovascular effects of sildenafil on patients with Fontan     circulation. Recent studies suggest that sildenafil may improve exercise in patients with     Fontan circulation. However, why this occurs is not known. The study will used specialized     catheters to measure pressure and volume. The measure of pressure and volume leads to more     detailed analysis of heart function. Patients will receive either sugar pill or sildenafil     prior to catheterization. It is believed that sildenafil will improve relaxation and     contraction of the heart.   "
112341|NCT01815489|"     Necrotizing pancreatitis is a severe form of inflammation of the pancreas with subsequent     destruction of the pancreas (necrosis). Often, this condition manifests in patients as an     overwhelming systemic inflammatory response and multisystem organ failure. Many times the     pancreas can become superinfected with bacteria and other organisms as a result of this     process. Clinicians may decide to sample fluid from the pancreas or pancreatic tissue to     determine the presence of infection. This can be done through surgery with a concurrent     debridement and drainage of the pancreas or by a radiologist using an ultrasound or CT guided     method to sample the pancreatic fluid. These samples are then sent for culture in the     microbiology laboratory. Culture results often reveal 1-2 types of infecting bacteria that     originate from the gastrointestinal tract. The investigators hypothesize that in actuality,     many different kinds of bacteria may infect the pancreas. This project uses molecular DNA     techniques to help identify bacteria present in the pancreas of patients with severe     necrotizing pancreatitis.   "
112342|NCT01815476|"     Participants undergoing radiation after breast conserving surgery for an early breast cancer     (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at     increased risk of developing a skin reaction because of their large breast size.      After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or     early stage invasive breast cancer receive radiation to the breast to decrease the risk of     cancer recurrence. Breast radiation is usually done with women lying on their back     (supine). Some women develop temporary breakdown of the skin (moist desquamation). This     skin reaction can be painful and has been linked to long term side effects such as chronic     pain and decreased quality of life.      This study is being done because women with large breasts have higher rates of skin breakdown     (called 'moist desquamation') and breast pain during and shortly after radiation therapy is     complete. It is unclear if such skin reactions and pain would be improved by alternating     treatment position - namely lying on your belly (prone) during their radiation treatment.   "
112343|NCT01815463|"     Hypothesis:The Adnab-9 antigen is a predictive biomarker in individuals at risk of developing     colorectal neoplasia.      Study aim is to evaluate the potential of the Adnab-9 monoclonal antibody (MAb) as a marker     of cancer risk in a population at increased risk for colorectal cancer (CRC). This marker     would be compared to other current and emerging diagnostic methods. 2,800 Veterans would be     recruited into the study. In phase 1, candidates would be defined as having increased CRC     risk by a short questionnaire. Stool samples would be obtained and a semi-quantitative     Adnab-9 antigen assay (ELISA) would be determined. Patients with differing high and low     estimations of fecal Adnab-9 would undergo colonoscopy at which time other samples of     effluent and colonic mucosa would be taken, and a detailed lifestyle and nutritional     questionnaire would be completed. The characteristics of the Adnab-9 fecal test as a     diagnostic test would be critically determined using the outcome of the colonoscopic and     other test results. The patients will be contacted through the mail and by word of mouth.     Informed consent will be obtained before the samples are obtained. The participants are     clinically defined as high-risk and therefore screening colonoscopy would be likely performed     in any event. A number of assays for Adnab-9 are feasible including slot-blot, Western blot,     and ELISA. Other stool studies include conventional fecal occult blood tests (FOBT or FIT)     that will be performed in tandem. The investigators therefore began this method of collection     and obtained consent from over 2000 patients with a similar overall compliance rate with FOBT     screening procedures to that reported previously of approximately 50%. Currently the study is     no longer enrolling patients at the Detroit VA and is now finalizing data entry. Another 450     patients to be recruited at the Philadelphia VAMC.   "
112344|NCT01815450|"     The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to     placebo for the treatment of moderate to severe acne vulgaris.   "
112345|NCT01815437|"     This study will evaluate how much vitamin D is present in a mushroom supplement. This     supplement contains an extract from mushrooms that have been exposed to sunlight. The     mushroom supplement will be compared to non-commercially available vitamin D supplements     produced in a Goo Manufacturing Practices (GMP)-licensed facility.   "
112346|NCT01815424|"     The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10     mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of     treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are     candidates for systemic therapy or phototherapy.   "
112471|NCT01813773|"     To assess the safety of intravitreal aflibercept injection in the treatment of proliferative     diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.   "
112347|NCT01815411|"     Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to     significant pain, joint destruction and functional decline, and has a substantial economic     impact both for sufferers and society. Although the etiology of RA is unknown, it is     generally accepted that it arises from an interplay of genetic predisposition (in particular,     HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g.     autoantibody production), and environmental factors. The prevalence and incidence of RA in     Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are     2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA     and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6).     RA is also associated with significant comorbidity; the most important is premature     cardiovascular disease that significantly contributes to increased mortality. Compared with     the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden,     and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of     RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids,     traditional disease modifying antirheumatic drugs (including methotrexate) and biologic     therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy).     Also, a considerable portion of the patients are in need of joint replacement surgery and in     need of rehabilitation.      However, the treatment opportunities are still not optimal. In a large proportion of the     patients, full control of the disease is not possible due to limited effect of available     therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new     therapeutic alternatives to treat RA.      Since studies on healthy volunteers and IBD-patients support that the mushroom extract     AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a     pilot study whether this effect also was evident in patients with RA. A potential     anti-inflammatory effect could prove beneficial in these seriously ill patients, who     accordingly could experience less side effects (edema, granulocytopenia, diminished tissue     repair) due to potential reduction number and dose of disease modifying drugs.   "
112348|NCT01815398|"     Many young people who are homeless have cognitive deficits which impede their ability to     secure and maintain employment. This study looks to see if targeting cognitive deficits can     improve cognition and vocational outcome.   "
112451|NCT01814033|"     The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or     function for a group of patients following total knee arthroplasty (TKA) who use the LRU     pillow as compared to a control group of total knee arthroplasty patients who do not use the     pillow.   "
112349|NCT01815385|"     Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure     to an adverse developmental environment, including environmental toxins, are linked to     increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the     mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong     evidence suggests that alterations in the epigenome play a critical role in this process. The     central hypothesis of this proposal is that intrauterine exposure to benzo[a]pyrene leads to     epigenetic changes which will have functional consequences and may be a marker for, or may     contribute to, increased susceptibility to adverse outcomes in childhood including increased     adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The     goals of this proposal are to: 1) determine benzo[a]pyrene levels in umbilical cord blood of     newborns, 2) determine whether benzo[a]pyrene exposure during pregnancy correlates with early     onset of obesity and metabolic disease by examining the children at 12 and 24 months of age,     3) determine whether in utero benzo[a]pyrene exposure programs metabolic disease through     alterations in DNA methylation and gene expression, and 4) determine the plasticity of the     DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of     this project is to define biomarkers that identify neonates at high-risk for diminished     attainment of full health potential, who can then be targeted for preventative measures.   "
112350|NCT01815372|"     Background and aims: Ultrasound-guided (USG) nerve blocks of the sciatic nerve (popliteal     level = PL) and the saphenous nerve (mid-femoral level = MFL) provides analgesia following     leg surgery. Traditionally two separate injections are performed. The aim was to describe a     novel, faster USG block combination requiring only one skin penetration to block the sciatic     and saphenous nerves; i.e. the SPEDI block = Single PEnetration Dual Injection.      Methods: A randomized, controlled and double-blinded trial. Following ethics committee     approval 60 patients will be randomized to the administration of an USG SPEDI block compared     to two separate USG blocks of the saphenous (MFL) and sciatic (PL) nerves. Blocks will be     performed after induction of general anaesthesia. Outcome measures will be performance time     (primary outcome measure), Post-Anaesthesia Care Unit pain scores (VAS scores 0-10), block     difficulty level (easy, middle, difficult), opioid consumption (in the PACU),     serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). Both block combinations will     be evaluated by MR imaging (MRI).      Hypothesis: The USG SPEDI block combination is expected to be performed significantly faster     without moving the leg, and achieve successful perioperative pain management. The SPEDI block     may find important use in the emergency setting.   "
112351|NCT01815359|"     This is the first randomized trial comparing Early post-operative intraperitoneal     chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal and     colorectal cancer. The purpose of this study is to find out what effects, good and/or bad,     EPIC and HIPEC after cytoreductive surgery have on the patient and the appendiceal, rectal or     colon cancer.   "
112352|NCT01815346|"     The goal of this clinical research study is to compare the level of effectiveness for 2     acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers also     want to study how patients may respond to acupuncture treatments, and how the treatments may     affect quality of life, hand function, balance, and the use of drugs for neuropathy pain.   "
112353|NCT01815333|"     The goal of this clinical research study is to learn if the drug Feraheme ® (ferumoxytole)     helps researchers most clearly to see cancerous lymph nodes on an MRI scan. Researchers     also want to learn if ferumoxytole may be used in liver imaging.      Ferumoxytole is designed to deliver iron to treat iron-deficiency anemia (low red blood cell     counts) in patients with chronic kidney disease. In this study, it will be used as an MRI     contrast. Contrasts are used by doctors in order to see MRI images more clearly.   "
112472|NCT01813760|"     The Diode laser system is being used in this marketing study for the treatment of wrinkles     around the eyes and mouth.   "
112473|NCT01813747|"     The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to     provide clinical outcome data for treatment of the mandibular and submandibular areas     specifically for skin tightening and laser lipolysis.   "
112812|NCT01809301|"     The objective of this study is to compare the absorption of a niacin metabolite     (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the     production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be used     to adjust the top dose of a planned TRIA-622 efficacy study.   "
112354|NCT01815320|"     Acute allograft dysfunction is often observed in the first weeks after kidney     transplantation. Renal biopsy is universally considered the gold standard procedure for     differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes.     Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover,     it may but not contribute to clinical diagnosis in about 10% of cases because of the     impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or     readily applicable non-invasive procedures might therefore allow increasing the performance     of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging     technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in     this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a     surrounding phospholipid monolayer and last for several minutes in the systemic circulation     before spontaneous degradation with absorption of the gaseous component by the lungs and the     phospholipid shell by the liver. With the use of gasfilled microbubbles that act as     scatterers within the blood stream and the development of low-MI ultrasound techniques that     allow the visualization of the bubbles without destroying them, it is possible to improve the     depiction of vessels and have access to structural and functional information on the     microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to     evaluate kidney disfunction.      Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be     associated with different patterns of renal graft involvement during acute renal function     deterioration and b. whether, conversely, different patterns of parenchymal perfusion     detected by CE-US may help predicting different patterns of renal involvement will be     investigated in 20 deceased or living donor kidney graft recipients.   "
112355|NCT01815307|"     To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after     hemihepatectomy.   "
112356|NCT01815294|"     The purpose of this study is to support the qualification of a replacement manufacturing site     for DOXIL/CAELYX (doxorubicin HCL).   "
112357|NCT01815281|"     The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical     stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive     Supranuclear Palsy both stable and with motor fluctuation.   "
112358|NCT01815268|"     The purpose of this study is to prospectively evaluate relative effectiveness of high dose     influenza vaccine in preventing influenza mortality, hospitalization, and functional decline     in a nursing home population in the U.S., compared to the standard dose trivalent seasonal     influenza vaccine.   "
112359|NCT01815255|"     This study will assess the safety and efficacy of generic TDF from Governmental     Pharmaceutical Organization (GPO) in HIV-infected children   "
112360|NCT01815242|"     The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either     carboplatin or gemcitabine for patients with triple negative breast cancer.   "
112361|NCT01815229|"     Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal     lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique.     Specimen samples obtained by wall suction will be collected at 2 time points following     intubation.      Blood samples will be obtained at 2 time points, simultaneous with the collection of the     tracheal specimens.   "
112362|NCT01815216|"     After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former     preponderance in relative short time (~ 2 years). But knowledge of the underlying biological     mechanisms of decline in body weight is still inadequate.      This project intends to examine patients' background activity in the brain (i.e. the resting     state activity) and brain volume using MRI both before and one year after surgery.   "
112363|NCT01815203|"     With the abundance of energy-dense foods that are designed for ease of consumption in the     current environment, it is of importance to better understand the factors that may undermine     the control of energy intake at healthy levels.      One of the factors that is potentially important in response inhibition is caffeine.      The aim is to assess the direct effects of caffeine on response inhibition, using a No     Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as     pictures, modulate response inhibition different in restrained vs. non-restrained eaters.   "
112364|NCT01815190|"     Cutaneous vasculitis due to vascular deposition of large circulating immune complexes is a     disease frequently seen by general practitioners and dermatologists. The clinical symptom is     palpable purpura with predilection for the lower legs.      In some cases vasculitis also affects systemic organs, such as the kidneys and the intestine.      When the immune complexes contain immunoglobulin class A (IgA) and when there is systemic     involvement, the disease has been referred to as Henoch Schönlein purpura.      When there are no signs of systemic involvement, the disease has been referred to as     cutaneous leukocytoclastic angiitis.      The investigators hypothesize that palpable purpura with predilection for lower legs is a     pathognomonic clinical sign for immune complex vasculitis in both IgA vasculitis and     IgA-negative vasculitis, but that only the presence of IgA in immune complexes is likely to     be associated with systemic involvement and therefore warrants more extensive diagnostic     procedures Vice versa the investigators postulate that the presence of IgG or IgM without IgA     in immune complexes excludes systemic involvement The investigators also want to investigate     to which of the 2 groups patients with palpable purpura and negative immunofluorescence     should be assigned.   "
112365|NCT01815177|"     Arthroscopic transosseous fixation of rotator cuff tears has become an alternative to     arthroscopic suture anchor.      This novel technique that allows surgeons to perform a standardized arthroscopic transosseous     (anchor free) repair of rotator cuff tears can improve postoperative pain and reduce the     incidence of shoulder stiffness.      The aim of the this study is to compare clinical outcomes of two groups of patients: patients     that received an arthroscopic transosseous fixation using the ArthroTunneler tunneling device     (Tornier Inc, Edina, Minnesota) versus patients that received an arthroscopic rotator cuff     repair using suture anchors.   "
112375|NCT01815021|"     Primary objective:      Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared     to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).      Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from     ACC compared to CCS can maintain target serum calcium (corrected for albumin) values     (7.0-10.0 mg/dL).      Secondary objectives:      Phase I        -  ACC dose selection - to confirm the conversion factor of ACC from CCS        -  To determine the effect of food on ACC absorption      Phase II        -  To test the hypothesis that treatment with smaller doses of elemental calcium from ACC          compared to CCS will not cause an increase in hypercalciuria in patients with          hypoparathyroidism        -  To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the          side effects related with high calcium consumption.      Amorphical has a strong basis to believe that the ACC product is better absorbed compared to     the commercially available CCS products and therefore, can maintain desirable target albumin     corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As     results, the burden of taking high doses of calcium supplementation along with the side     effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be     reduced.      Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a     straightforward method to test this hypothesis.      The study is designed to be conducted with extra precaution in order to avoid disturbing the     fragile balance between CA levels in serum and calcium levels urine. The crossover design of     phase II of the study allows a more accurate and reliable comparison of results attributable     to the specific treatment within the same individual. In addition, the subjects will continue     consuming all their routine medication throughout the trial. The subjects in the control arm     will consume their routine calcium supplement doses thus, will be treated with a standard of     care.   "
112366|NCT01815164|"     Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this     therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational     intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44 women     with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen level     dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI) during     expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal distensions.     Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational intervention     (EDU). 31 patients completed the treatments and the post treatment fMRI. Results: Similar     symptom reduction was achieved in both groups. HYP responders demonstrated a pre-post     treatment BOLD attenuation in both anterior and posterior insula during high intensity     distension, while EDU responders had a BOLD attenuation in prefrontal cortex. Pre-post     differences for the low distension and for the two expectation conditions were almost     exclusively seen in the HYP group. For all responders there was a significant correlation     between treatment induced reduction of GI related anxiety and BOLD decrease in the anterior     insula. Following treatment, the brain response to distension was similar to that observed in     HCs, suggesting that the treatment had a normalizing effect on the central processing     abnormality of visceral signals in IBS. Conclusions: The abnormal processing and enhanced     perception of visceral stimuli in IBS can be normalized by psychological interventions.     Symptom improvement in the treatment groups may be mediated by different brain mechanisms.   "
112367|NCT01815138|"     This a prospective randomized double blind study involving patients at high risk of OHSS     development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in     patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant     hCG 1,500 IU 35 hours after GnRH agonist trigger.   "
112368|NCT01815125|"     Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present     persistent symptoms at one week post injury. A systematic review showed a paucity of studies     for short term outcomes following mTBI. Among potential treatments for mTBI, ondansetron has     shown promising results based on clinical experience and a single retrospective study.     Objectives: The primary objective of this pilot study is to determine the feasibility of a     randomized controlled trial evaluating the effect of ondansetron to decrease post concussion     symptoms at one week following mTBI in children. More specifically, this pilot study will     evaluate the proportion of participants who complete assessment at one week following     intervention. Method: This will be a randomized, double blinded, controlled trial performed     among children aged between 8 and 17 years old who sustained a mTBI in the previous 24 hours.     Participants visiting the emergency department will be randomized to receive one dose of     either ondansetron or placebo. The primary outcome of interest is defined as an increase from     pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory     (PCSI) one week following trauma. Secondary outcomes will include time to full recovery, mean     PCSI score, and outcomes at one month following head trauma. The primary analysis will     compare the proportion of participants with persistence of symptoms at one week in both     groups. The full study sample size was calculated to have 90% power to detect a decrease in     the proportion of persistence of symptoms from 50% to 30% with an alpha value of 0.05.     Approximately 126 patients will therefore be recruited in each arm. The investigators plan to     recruit 30 participants (10% of the final population) for the pilot study. Expected results:     This pilot study should confirm the feasibility of the randomized controlled trial by showing     that 90% of the recruited participants provide data on the primary outcome at one week     following intervention. On the long term, the investigator expect that ondansetron will     decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to     lower than 30%.   "
112380|NCT01814956|"     Aim is to investigate the influence of an early supply of parenteral nutrition including a     fish oil containing lipid emulsion on the course of acute lung injury in the intensive care     unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will     be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil     derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung     injury.   "
112452|NCT01814020|"     Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with     fungal nail infection.   "
112453|NCT01814007|"     To evaluate if multiple same-day CoolSculpting treatments increase the risk of abnormal     lipids and liver-related tests.   "
112369|NCT01815112|"     The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus,     the search for objective markers of preclinical first signs of cognitive impairment, is     currently a major public health issue. Early detection of the disease is a major challenge to     hope to slow or even stop the neurodegenerative process before the stage of dementia.      In AD the investigators observe:        -  A reduction in the volume of brain hippocampi associated with an alteration of the          diffusion of water molecules in the white matter.        -  A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.      Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to     dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to     conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that     aim,the investigators use two imaging modalities:        -  Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain        -  Positron emission tomography (PET) is used to assess glucose metabolism in grey/white          matter and also in choroid plexus.      The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be     altered as well as glucose metabolism dynamic in choroid plexus.   "
112370|NCT01815099|"     We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS)     for patients with GAD who were placebo nonresponders in DIEF003523.1.   "
112371|NCT01815086|"     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive     monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by     PET/CT imaging in patients with AL amyloidosis.   "
112372|NCT01815073|"     The purpose of this study is to observe the occurrence of adverse events and seroconversion     rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE     vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine,     respectively.   "
112373|NCT01815047|"     The goal of this study is to characterize the function and efficacy of the bioactive     nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The     three specific aims of this study are 1) To address the impact of maternal vitamin D status     on inflammation and infections across pregnancy using retrospective data, 2) To address the     impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections     across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D     status during pregnancy on inflammatory mediators at the level of the placenta.   "
112376|NCT01815008|"     This clinical trial is examining the role of genetic polymorphism on the effect of     clopidogrel (with or without aspirin) on platelet response in persons at high-risk for     myocardial infarction or stroke due to family history of early-onset coronary artery disease.   "
112377|NCT01814995|"     Women with a history of 'diabetes in pregnancy' or Gestational Diabetes (GDM) have a high     risk for type 2 diabetes later in life. This can often be prevented, however, with     improvements in eating habits and higher physical activity levels. However, many women find     it difficult to alter their lifestyle habits, especially if they have young children. In     adults with type 2 diabetes, the investigators have been studying the effects of combining     nutrition education with meal preparation training and pedometer-based self-monitoring to     improve eating habits and increase activity levels. The investigators have shown that such a     strategy can reduce hemoglobin A1C by 0.3% and correlates with small reductions in weight     (Dasgupta et al, International Journal of Behavioural Nutrition and Physical Activity, 2012).     In developing the present interventional study, we presented this strategy to women with a     GDM history and asked them how they would modify it to suit their needs. They expressed     strong interest in such an approach but emphasized a need to involve their spouses and     provide childcare support. They did not express interest in use of meal replacements.     Therefore, in MoMM-intervention phase, the investigators will examine the effects of a once     per month (4 session) program combined with Internet/telephone-based support. The four     sessions with include meal preparation training, strategies to limit mindless eating and     improve meal content and portion control. All sessions will offer child care. Two sessions     will involve spouses. The investigators will assess effects on weight, BMI, DXA measures of     fat, and measures of insulin resistance and blood pressure. This single-arm intervention     study may lead ultimately to a randomized controlled trial.   "
112378|NCT01814982|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores     what the body does to the drug) and pharmacodynamics (the study of the action or effects a     drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and     chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain     stem).   "
112379|NCT01814969|"     Clinical objective of the study is to compare the rates of pathologic response, acute     toxicity and sphincter preservation with two schedules of preoperative regiment in patients     with locally advanced rectal cancer.   "
112408|NCT01814592|"     The aim of this study is to evaluate the effectiveness of total root coverage between two     coronally positioned flap technique in Miller recession Class I and II, in patients attending     at Universidad El Bosque dental school clinics.   "
112381|NCT01814943|"     This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained.     The aims of the post hoc analyses are:      To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for     secondary prevention of vascular disease and the relative risk of UPU associated with use and     discontinuation of use of low dose ASA.      To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users     of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other     risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of     vascular disease.   "
112382|NCT01814930|"     Postpartum contraceptive counseling varies widely in its provision; no standardized practice     has been well-established by the literature. We intend to evaluate how directed postpartum     contraceptive counseling to adolescents aged 14-19 affects key outcomes over time. Subjects     will be randomized to receive either the standardized contraceptive counseling intervention     or routine postpartum care. We will then assess the difference in repeat pregnancy rates     between the two groups   "
112383|NCT01814917|"     The Primary Objectives of this study are to assess the long-term efficacy of treatment with     colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of     treatment with colestilan (MCI-196) (including combination therapy).   "
112384|NCT01814904|"     The Primary Objective of this study is to determine the initial starting doses of colestilan     (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with     Hyperphosphataemia.   "
112385|NCT01814891|"     Determination of liver stores of vitamin A will be determined before and after consumption of     high pro-vitamin A orange maize, compared to low provitamin A white maize.   "
112386|NCT01814878|"     The purpose of this study is to compare the efficacy and safety of extended release (ER)     tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol     HCl/acetaminophen in participants with moderate to severe (very serious, life threatening)     postoperative pain.   "
112387|NCT01814865|"     This study is being offered to patients who are post-menopausal, have breast cancer with a     positive estrogen and/or progesterone hormone receptor test and are currently awaiting     surgery for breast cancer.      The purpose of this study is to determine whether abiraterone acetate has different hormonal     and genomic effects than non-steroidal aromatase inhibitors in the treatment of     post-menopausal hormonal receptor positive primary operable breast cancer   "
112388|NCT01814852|"     This is a prospective, randomized, double-blind clinical study for assessing the safety and     efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.   "
112389|NCT01814839|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer subjects.   "
112390|NCT01814826|"     This study is an open-label, multicenter, phase 1b, dose-escalation study of MLN4924 in     combination with azacitidine in adult patients with AML. The patient population will consist     of patients 60 years of age or older, previously diagnosed with World Health     Organization(WHO)-defined AML, who are unlikely to benefit from standard induction therapy     and who have not received definitive treatment for AML or prior treatment with azacitidine or     decitabine.   "
112391|NCT01814813|"     This randomized phase II trial studies how well giving vaccine therapy with or without     bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be     removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a     person's own tumor tissue may help the body build an effective immune response to kill tumor     cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them. It is not yet known whether giving vaccine     therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.   "
149432|NCT01328093|"     The purpose of this study is to determine whether weight gain will be significantly less in     LY2140023 than aripiprazole in patients with schizophrenia.   "
112393|NCT01814787|"     Increasing rates of type 2 diabetes among children and adolescents has considerable long-term     implications not only for the affected individuals, but also for society and the health     system as a whole. Pediatricians have unique and important opportunities to screen for type 2     diabetes and to promote lifestyle modification for those children identified with     pre-diabetes; yet implementation of these practices within the pediatric primary care setting     is far from ideal. The purpose of this study is to implement the ADA screening guidelines for     type 2 diabetes and clinical management prompts within a pediatric primary care setting using     a computer decision support system (CDSS) developed by the investigators research group - the     Child Health Improvement through Computer Automation (CHICA) system. The investigators     hypothesize that the coupling of CDSS with ADA guidelines will result in greater compliance     with ADA recommended screening procedures as well as better clinical management of children     identified as having pre-diabetes or type 2 diabetes.   "
112394|NCT01814774|"     This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins     BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of     Cervical Dystonia and Blepharospasm in clinical practice.   "
112395|NCT01814761|"     This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle     glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated     intraocular pressure (IOP).   "
112396|NCT01814748|"     This study will examine the safety and efficacy of once-weekly omarigliptin in participants     18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The     study hypothesis is that treatment with omarigliptin compared with placebo provides greater     reduction in hemoglobin A1c (A1C) in participants after 24 weeks.   "
112397|NCT01814735|"     Currently, India has the largest absolute number of people with diabetes in the world, and     evidence indicates that consumption of whole-grains can decrease diabetes by improving     glycemic control. Our study will evaluate the efficacy of substituting brown rice, a     whole-grain, for white rice in Chennai, India, on biomarkers of diabetes risk. The ultimate     goal of this research is to provide data for use in designing a global dietary intervention     study aimed at reducing diabetes risk through simple, culturally appropriate, feasible and     sustainable dietary changes.   "
112398|NCT01814722|"     This is a multi-center, longitudinal observational study of adult human immunodeficiency     virus (HIV) participants at academic and community-based practices in the United States who     are switching from first-line to second-line therapy. The study's primary hypothesis is that     HIV participants switching to raltegravir-based regimens will have better Medical Outcomes     Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside reverse     transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.   "
112399|NCT01814709|"     This open-label, two-arm, drug interaction study will investigate the effect of     co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy     volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers     will receive GDC-0032 and itraconazole. The anticipated time on study treatment is     approximately 30 days.   "
112400|NCT01814696|"     The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted     medication adherence device and reminder system, on medication adherence and clinical     outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction     derived from using this system.      We hypothesize that:        1. The use of the MedSentry system will improve medication adherence in patients with a          discharge diagnosis of HF.        2. The improvement in adherence correlates with fewer hospitalizations and emergency          department (ED) visits.        3. The improvement in adherence correlates with better health-related quality of life.   "
112401|NCT01814683|"     The main determinant of primaquine efficacy is the total dose of primaquine administered,     rather than the dosing schedule. Previous trials have demonstrated that the standard low dose     regimen of primaquine (3.5 mg/kg total) fails to prevent relapses in many different endemic     locations. For this reason the 2010 WHO antimalarial guidelines now recommend a high dose     regimen of 7 mg/kg (equivalent to an adult dose of 30mg per day), although many countries     still recommend lower doses for fear of causing more serious harm to unscreened G6PDd     patients.      Shorter courses of higher daily doses of primaquine have the potential to improve adherence     and thus effectiveness without compromising efficacy. Primaquine also has relatively weak but     clinically relevant asexual stage activity against P. vivax so larger daily doses may     substantially augment chloroquine's blood stage activity at low levels of resistance. In     Thailand directly observed primaquine (1mg/kg/day) administered over 7 days was well     tolerated and reduced relapses by day 28 to 4%. This is encouraging but not definitive since     many relapses present after one month. Longer follow-up is needed to distinguish whether     relapse was prevented or deferred. If the efficacy, tolerability and safety of short-course,     high-dose primaquine regimens can be assured across the range of endemic settings, along with     reliable point-of-care G6PDd diagnostics, then this new primaquine regimen would be a major     advance in malaria treatment improving adherence to and thus the effectiveness of     anti-relapse therapy.      Due to the long duration of standard primaquine treatment regimens, courses are difficult to     supervise, are poorly adhered to and lack effectiveness. This proposed multicentre randomised     clinical trial will provide evidence across a variety of endemic settings on the safety and     efficacy of high dose-short course primaquine in G6PD normal patients. In a parallel single     arm study the investigators will also gather safety data on the use of weekly primaquine in     patients with G6PDd. This study aims to generate evidence that will directly inform global     public health policy for the radical cure of P. vivax. A better understanding of the risks     and benefits of primaquine is crucial in persuading policy makers and clinicians of the     importance of the radical cure of vivax malaria that will reduce the parasite reservoir and     decrease transmission.   "
112402|NCT01814670|"     A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in     Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated     with facial laser resurfacing.   "
112423|NCT01814397|"     Postmenopausal women who have hormone receptor positive breast cancer are typically treated     with aromatase inhibitor medications, which substantially decrease the amount of estrogen     produced by their bodies. These medications are fairly well tolerated, but can cause aches     and pains which can be quite severe in some cases.      People experience pain differently. Estrogen appears to play a role in how we experience     pain. Therefore, decreasing estrogen levels may lead to more pain in some women than others.     The goal of this study is to evaluate perception of pain in women with breast cancer, and to     determine if differences in pain perception lead to more aches and pains in some women     treated with aromatase inhibitors.      In this study, we plan to enroll 55 women with breast cancer who are starting treatment with     an aromatase inhibitor. Participants will undergo testing to evaluate their perception of     pain, and will also complete a set of questionnaires. Testing will be conducted before     starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. We will     investigate whether pre-existing differences in pain perception lead to different amounts of     pain during aromatase inhibitor therapy.   "
112403|NCT01814657|"     This study is for patients undergoing In Vitro Fertilization (IVF). The investigators are     studying the best way to control pain during the egg retrieval process. The egg retrieval     involves passing a needle under ultrasound guidance through the vagina into the ovaries to     remove eggs that are to be later fertilized. Patients often report this as very     uncomfortable.      Different fertility clinics across the country use different methods of pain control. All     clinics will use intravenous medication to control pain, while some may or may not use local     anaesthetic (freezing) in the vagina. Our goal is to find the best way to control pain. Since     local anaesthetic injection involves multiple needle punctures and may be painful, the     investigators are unsure if local anaesthetic is necessary in addition to the intravenous     pain medication.      The investigators will conduct a randomized trial where all patients will receive intravenous     pain medication, but some will receive local anaesthetic injection and some will receive     placebo injection. Patients will be asked to complete a questionnaire on their pain     experience after oocyte retrieval. The investigators will then analyze the data and determine     whether local anaesthetic actually improves pain when patients are already receiving     intravenous pain medications. Through our study, the investigators aim to improve the pain     experience of all women undergoing IVF in the future.   "
112404|NCT01814644|"     This project will test the efficacy of the TRIMM (Tailored Rapid Interactive Mobile     Messaging) program, a user‐friendly, semi‐individualized text-messaging intervention to     facilitate lifestyle change and weight loss among obese African-American adults with or at     risk for diabetes, in a pilot, controlled clinical trial.      The text-messaging intervention will be in addition to, and compared with traditional diet,     behavior, and physical activity education. Tips will be designed to increase knowledge,     skills, and motivation.   "
112405|NCT01814631|"     The primary objective for this study is to compare the image quality of two endoscopic     ultrasound (EUS) processors used for imaging of the pancreas. Processor images are used to     make a correct clinical diagnosis and higher quality imaging is related to more accurate     results. Patient care may be improved due to the information collected as part of this study.      The quality of imaging is of utmost importance for diagnosing early neoplasms in the pancreas     and diseases such as chronic pancreatitis. Image quality is dictated by two factors: image     resolution and depth of penetration. Good imaging enables diagnosis of early stage disease     and thereby facilitates early treatment.   "
112406|NCT01814618|"     The purpose of this study is to determine if a trial of directed high-dose nasal steroids     improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery.     Other outcomes of this study include: identifying the differences in sinus airflow between     patients who improve following nasal steroid treatment and those who do not, and to see if,     in patients who improve following surgery, the improvement remains throughout follow-up.   "
112407|NCT01814605|"     A new ultrasound-guided subgluteal space approach to sciatic nerve block that has been     recently described obviates the need to identify the sciatic nerve. The investigators     hypothesize that the use of an ultrasound-guided subgluteal space injection to perform     sciatic nerve block will increase the proportion of patients experiencing complete sensory     block in both terminal branches of the Sciatic nerve in comparison to the same proportion in     those who receive the block via ultrasound-guided infragluteal approach with circumferential     injection in patients scheduled for unilateral TKA(total knee arthroplasty) surgeries.   "
112410|NCT01814566|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in January 2013.      It was funded by China major scientific and technological specialized project for     'significant new formulation of new drugs'.      DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart     disease and angina pectoris in many Chinese hospitals.      The purpose of this study is to determine adverse drug events or adverse drug reaction in     large sample size 30,000 patients.   "
112411|NCT01814553|"     This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the     use of diarrheal management tools intended to facilitate timely intervention and treatment     modifications due to afatinib treatment-related diarrhea in patients with EGFR     mutations-positive adenocarcinoma of the lung. Patients in Cohort 1 will follow diarrhea     management. Patients in Cohort 2 will receive prophylactic loperamide starting the fist day     of afatinib treatment.   "
112412|NCT01814540|"     The purpose of this study is to elucidate tolerability and effectiveness in consumption of     the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO)     to enrich intestinal microflora toward beneficial populations.   "
112413|NCT01814527|"     Concussions are defined as a complex pathophysiological process affecting the brain, induced     by traumatic biomechanical forces. Currently the standard of care in the treatment for     concussions is cognitive and physical rest until symptoms resolve with a graduated return to     activity. High dose omega-3 fatty acids have shown to have anti-inflammatory, anti-oxidant,     and membrane stabilizing properties. They have also been used in treatment of severe     traumatic brain injury. The purpose of this study is to determine if early high dose omega-3     fatty acid supplementation in Division I National Collegiate Athletic Association (NCAA)     athletes that have sustained a concussion will decrease the number of days out of competitive     sports with a quicker symptom resolution, return to baseline neurocognitive functioning and     postural stability using a randomized double blind placebo controlled study design. Once an     athlete is identified as having sustained a concussion by the East Carolina University Sports     Medicine staff and qualifies for the study, he/she will randomly be assigned to either high     dose omega-3 fatty acid or placebo. Both groups will undergo standard and usual care for     concussed athletes at East Carolina University. The number of days it takes the athlete to     return to competitive athletics will be recorded, along with time to symptom resolution,     normalization of their computerized neurocognitive testing (ImPact) and computerized postural     stability testing (Biodex BioSway).   "
112445|NCT01814111|"     The purpose of this study is to demonstrate whether renal sympathetic denervation is safe and     effective in patients with hypertension and paroxysmal atrial fibrillation.   "
112446|NCT01814098|"     The purpose of this study is to evaluate the efficacy and safety of long term escitalopram     treatment in participants with Major Depressive Disorder (MDD) with associated anxiety     symptoms.   "
112414|NCT01814514|"     The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus     maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device     (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The     hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by     the hypertensive period where the IOP tends to rise steadily above 21mmhg.      The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved     implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase     can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is     intense congestion of the bleb wall, that IOP is highest.      Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's     capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue     growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators     induce an inflammatory reaction, and if excessive, will result in fibrosis and poor     functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β     by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis     and poor bleb function. The investigators supposed that with early use of aqueous suppressant     medication after AGV implantation, the concentration of inflammatory mediators decreased in     subconjunctival space and may lead to better IOP control after shunt surgery.   "
112415|NCT01814501|"     This phase II trial studies how well panitumumab and combination chemotherapy works in     treating patients with metastatic colorectal cancer previously treated with combination     chemotherapy and bevacizumab. Monoclonal antibodies, such as panitumumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in     chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Giving panitumumab and combination chemotherapy together may kill more     tumor cells   "
112416|NCT01814488|"     The experimental treatment consists in the application of a therapeutic strategy of     allogeneic transplantation as a potential curative procedure in a population of patients with     chemoresistant acute leukemias.      Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are     based on regimens currently in standard use in the context of allogeneic transplantation.   "
112417|NCT01814475|"     This study will be performed as a prospective multicenter phase II trial for compare     busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC     regimen prior to allogeneic transplantation of hematopoietic cells for the treatment of     myelofibrosis.      The primary endpoint for this study is to compare Progression Free Survival of two different     RIC regimens for allogeneic stem cell transplantation in myelofibrosis.      Progression Free Survival is defined as the time from the date of randomization to the date     of the first documented disease progression or relapse (according to the International     Working Group Consensus Criteria) or death due to any cause. Patients who have neither     progressed nor died at the time of study completion or who are lost to follow-up are censored     at the data of the last follow up for progression of disease for this study.   "
112418|NCT01814462|"     The present study aims to document and assess changes in single parameters of pulse wave     analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment     before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with     obstructive sleep apnea.   "
112419|NCT01814449|"     The aim of our current study was to analyze whether 18F-labeled Fluoromisonidazole     (1-(2-nitro-1-imidazolyl)- 2-hydroxy-3-fluoropropane [18F-FMISO]) PET/CT and expression of     HIF-1-alpha could predict response of primary endocrine therapy in ER-positive breast cancer   "
112420|NCT01814436|"     Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem     Cells from Human Exfoliated Deciduous Teeth   "
112421|NCT01814423|"     Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous     research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95%     efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of CQ     is increased. Severe adverse events are caused by high peak concentrations of CQ. Using split     doses of CQ avoids high peak concentrations enabling the safe administration of high doses,     however, pharmacokinetic data are lacking.      Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg     as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse     events will be monitored. On day 1, children and their mother/guardian will be requested to     stay at the health centre between 9 am and 6 pm.      Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the     inclusion criteria will be recruited into each study arm.      Following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and     28.      Any child wishing to withdraw during the treatment phase and any child with reparasitaemia     during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine     according to treatment guidelines in Guinea-Bissau.      Final analysis will include a description of included children, proportions of adverse events     and any serious adverse events, drug concentrations and their relation to adverse events, the     proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and     uncorrected success and failure rates on day 28 and the proportion of early, late clinical     and late parasitological treatment failures.   "
112422|NCT01814410|"     There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive     performance and behavior in humans. The main objective of this study is to characterize the     interactive effects of acute intravenous (IV) ethanol and nicotine administration on     cognition and behavior in healthy smokers. The general hypothesis is that nicotine will     attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative     effects of ethanol.   "
112447|NCT01814085|"     The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment in     participants with severe major depressive disorder (MDD [marked depression appearing in the     involution period and characterized by hallucinations, delusions, paranoia, and agitation]).   "
114322|NCT01789476|"     This is a single-center, randomized, double blind, placebo controlled, parallel group proof     of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and     pharmacokinetic profile of CR845 in patients with pain following bunionectomy surgery.   "
112424|NCT01814384|"     Total knee arthroplasty represents over 70 000 surgical procedures per year in France,     increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate     of success on pain relieve and improvement of knee articular function for these patients.      Longevity of the implants had been proved to depend on the biomechanical design and     implantation techniques, particularly the bone cuts during the surgery. To improve the     precision of these cuts, the patient matched cutting blocks developed by Medacta company     allows to adapt bone cuts to the patient anatomy improving the reliability of these     procedure. A reduction of surgical time and bleeding would be another benefit expected with     this type of ancillary. The objective of this study is to demonstrate the advantage of     patient matched cutting blocks for total knee arthroplasty on realiability for both clinical     and radiological criteria, morbidity reduction during and after the procedure and also a     benefit on an economic point of view.   "
112425|NCT01814371|"     The purpose of this research study is to compare the effectiveness of commonly used     decolonization treatments (application of mupirocin antibiotic ointment to the nose and     bleach baths) when performed by individuals with a history of skin and soft tissue infection     (SSTI) in the prior year (individualized approach) in comparison to decolonization of all     household members (household approach) in an attempt to prevent Staphylococcus aureus skin     infections. The investigators hypothesize an individualized decolonization approach will be     equally as effective as a household approach to prevent SSTI.   "
112426|NCT01814358|"     Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel     dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood     vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in     blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein     effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in     normal weight and obese adults. This study will investigate the efficacy of drinking a whey     protein beverage prior to eating for improved daily blood sugar control in normal weight and     obese adults in the real world. Also, the study will test this dietary approach to reduce     blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24     normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects     will wear a sensor to monitor daily blood sugar changes in response to their typically     consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the     monitoring period for measurement of blood vessel function after eating a breakfast cereal     meal. Blood samples will be obtained before and after the meal to measure relevant health     markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week     or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein     (control) shake prior to each meal. Neither subjects nor researchers will know which protein     (double blind). Subjects will receive the alternate protein intervention after another week     or more (crossover). We think drinking the protein shake prior to meals will reduce daily     blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results     from eating the breakfast cereal.   "
112440|NCT01814176|"     During Anesthesia many patients require that a breathing be inserted into their windpipe.     This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a     light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more     force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope     uses a camera and light source to see the windpipe. This enables the user to see objects that     may not be in the direct line-of-sight. This likely results in less force being required,     reducing patient stress. Because such stresses are often confounded by patient variables, we     are comparing the forces required by the direct and video laryngoscopes on patients with at     least one risk factor for difficulty, by directly measuring these with special sensors     attached to the laryngoscope blades.   "
112441|NCT01814163|"     This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line     therapy in patients with non-squamous advanced non-small cell lung cancer.   "
112427|NCT01814345|"     Gastric cancer remains a major health issue and a leading cause of cancer death worldwide,     although the prevalence and mortality of the disease have gradually decreased. The     investigators have very few options for patients with advanced disease.      The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of     patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy     of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall     survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months;     HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit     was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall     survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this     study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2     testing is recommended for all patients with advanced gastric cancers and type III     oesophageal adenocarcinomas.      Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100     patients with IHC and FISH in 2+ and 3+ patients.   "
112428|NCT01814332|"     This purpose of this study is to look at the safety of the experimental drug GSK561679 as     well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress hormones,     and mental health symptoms in comparison to placebo (an inactive substance).   "
112429|NCT01814319|"     Probenecid is an FDA approved drug for the treatment gout and hyperuricemia. It has been used     safely in humans for decades for this and other indications. The investigators have recently     discovered that this drug can also stimulate other receptors in the heart and therefore     improve its function. The hypothesis of this study is that probenecid can be used to improve     the function of the heart and therefore the symptoms in patients with heart failure.   "
112430|NCT01814306|"     There is no significant difference about success rate of two devices.   "
112431|NCT01814293|"     This is a nonblinded randomized controlled trial which is a survey-based comparison between     supportive treatments for symptom relief from pediatric upper respiratory infection (URI).     The primary objective of this study is to determine if the use of handheld humidifier     improves URI symptom scores and/or reduces use of over the counter medications compared to     other supportive treatments for pediatric URIs (ie. OTC cold medications, room air     humidifier). Study duration is approximately 1 year and the individual intervention is 4     days.   "
112467|NCT01813825|"     A registry is an observation database. Participation in this registry does not require any     additional or different procedures or drugs other than those you would normally receive for     breast cancer. Registry databases are used to identify trends in medical care that help the     medical community identify optimal care for different diseases.      The data will be compiled on the safety and performance of the Partial Breast Brachytherapy     Applicator based on the information collected about the treatment and follow up visits.   "
112432|NCT01814280|"     Background:      Medication reviews performed on admission to hospitals reduce medication errors; however,     evidence of effect on morbidity and mortality is currently inconsistent. It is known that     patients' risks of experiencing medication errors are dependent on both patient- and drug     factors, e.g. age, co-morbidity, number of drugs, risk of side effects.      Aim and hypothesis:      The aim of this pilot study is to study acute medical patients' risk of getting a medication     error based on an algorithm that takes into account both patient and drug related factors.     Secondary, the investigators will explore whether our methods are applicable in a randomised     controlled trial. The investigators will also decide the number of patients in a randomised     controlled trial based on this pilot study.      The hypothesis is that an algorithm that has already been developed can stratify patients     according to their risk of experiencing a medication error.      Methods:      100 acute admitted patients will be risk stratified at admission (>8 hours after). The     patients who have highest risks of medication errors will receive a medication review     performed by either a clinical pharmacist or a clinical pharmacologist.   "
112433|NCT01814267|"     The aim of the study is to assess the cost-effectiveness of telemedicine in the care of     chronic diabetic foot ulcers.      Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to     diabetes specialist or 2/innovative care (telemedicine group).      the health insurance system perspective is adopted.   "
112434|NCT01814254|"     Estimation of hydration state in dialysis patients is a major challenge in clinical practice.     Although many methods have been studied, none have been established yet for clinical routine     practice.      The investigators have developed a method, using segmental and calf bioimpedance spectroscopy     (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved     Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to     measure whole body and segmental body fluid volumes but Hydra is approved only for measuring     healthy subjects. The cBIS monitors hydration state by continuously measuring change in     resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple     measurement before, during and after dialysis. Preliminary results in clinical studies have     shown that optimal hydration state of HD patients may be determined by the calf method. This     study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz)     Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified     version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8     mA current instead of 100 kHz and 2 mA.      The subjects of this study include a group of hemodialysis patients and a group of healthy     controls. The healthy controls are used to identify a normal range within the healthy     population for each method. Each hemodialysis patient will be studied twice in different     hydration state. The study will not change the procedure of the patient's dialysis treatment.     Since all devices are based on noninvasive bioimpedance technique, this study has minimal     risk.   "
112435|NCT01814241|"     The purpose of this study is to attempt to understand how desensitization works in peanut     allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify     the early changes in the desensitization process the immune cells undergo to become     desensitized to the peanut protein.   "
112436|NCT01814228|"     Cardioinhibitory neurocardiogenic syncope (CNS) or vasovagal syncope, is the most frequent     aetiology of syncope in young people without apparent cardiac or neurological pathology. It     is usually caused by inappropriately trigger-activated cardiac reflex which finally     precipitates asystole, sinus bradycardia, or atrioventricular (AV) block [1]. Despite young     patients affected by CNS have an excellent prognosis when electro-structural heart diseases     are excluded [2], their quality of life may be seriously affected by recurrent episodes [2,     3]. Cardiac pacing might help to control symptoms and therefore is considered in patients     aged more than 40 years old with recurrent episodes and documented cardioinhibitory response     [1, 4]. In young individuals, the role of cardiac pacing is dubious due to predicted frequent     device substitutions and adverse ventricular remodeling over time. Recently, radiofrequency     (RF) biatrial ablation of ganglionated plexi (GP) has showed promising results in the short     and long-term treatment of reflex syncope, functional atrioventricular block, or sinus node     dysfunction [5, 6]. Nonetheless, strong evidences are emerging about efficacy of     transcatheter ablation limited to ganglionated plexi in the right atrium with the possibility     to avoid side-effects related to left-sided procedures [6]      Aim of study      To evaluate in a large cohort of patients effectiveness and safety of gangliar transcatheter     ablation in the right atrium to obtain atrial denervation and prevent CNS.      Study population and methods      Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be     enrolled in the study.      Inclusion criteria:        -  age between 18 and 60 years        -  3 syncopal episodes at least of likely CNS in the previous 2 years        -  marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop          recorder registration [7].      Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV     block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.      Exclusion criteria:        -  documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection          fraction lower than 50%)        -  documented tachyarrhythmias as possible causes of symptoms        -  channelopathies (Brugada syndrome, LQT or SQT syndrome)        -  ventricular preexcitation        -  symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement        -  pregnancy in women        -  previous cardiac pacemaker implantation.      After obtaining informed consent patients will undergo to basal electrophysiological study     (EPS) to record AH interval, HV interval, Wenckebach cycle length, sinus node recovery time     (SNRT) and correct sinus node recovery time (cSNRT); the same parameters will be recorded     immediately after ablation. Following basal EPS an accurate (200 valid points at least)     electroanatomic right atrium mapping (CARTO 3™ Biosense Webster, Inc) will be performed and     subsequently radiofrequency delivered at right atrial anatomic sites where the underlying     presence of ganglionated plexi (GPs) clusters was regarded as highly probable, on the basis     of anatomical studies [8-11]: the supero-posterior area (superior right atrial GP, adjacent     to the junction of the superior vena cava and the posterior surface of RA), the     middleposterior area (posterior right atrial GP, posterior surface of the RA adjacent the     interatrial groove), the infero-posterior area (inferior right GP placed between the inferior     vena cava, coronary sinus ostium, and near the atrioventricular groove). Transcatheter     ablation will be performed using an 8mm-tip catheter (Biosence-Webster Navistar DS 8mm) or an     irrigated 4 mm-tip catheter with force control system (Biosence Webster Smarttouch). Ablation     will be performed until complete elimination of local atrial electrical activity. Response to     radiofrequencies delivery will be considered successful in case of asystolic pause or cardiac     cycle lengthening of 30% (compared to basal cycle) at least. To prolong RF delivery despite     asystolic response, a quadripolar catheter will be positioned in right ventricle to backup     stimulation. To avoid phrenic nerve injury, high amplitude stimulation will be performed just     before radiofrequency delivery to the superior right atrial GP.      HRV analysis will be performed on admission, at 2 hour after ablation and patients discharge.     The HRV analysis will include the following parameters: mean, maximal and minimal heart rate,     SDNN (standard deviation of Normal-Normal), RMSSD (root mean square successive difference),     pNN50 (percentage of differences between adjacent N-N intervals that are >50 msec), LF (low     frequency), HF (high frequency).      Moreover, an HUT and an HRV analysis will be performed at 1, 3, 6 and 12 months after     ablation procedure during the follow up.   "
112437|NCT01814215|"     The purpose of this project is to evaluate the efficacy of a 9-month Family Child Care Home     (FCCH)-based intervention, Keys to Healthy Family Child Care Homes, to increase the physical     activity and improve the diet quality of children (1.5 to 4.9 years).   "
112438|NCT01814202|"     The purpose of this study is to determine whether a medical nutrition product, PTM202, along     with standard of care, enhances recovery and reduces diarrhea morbidity in young children   "
112439|NCT01814189|"     The purpose of this study is to show the efficacy of promethazine in management of patients     with moderate to severe migraine   "
118209|NCT01738698|"     The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg     are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).   "
112442|NCT01814150|"     Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including     lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.      One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein.      Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with     the outcome of docetaxel based therapy in cancer patients.      The investigators aim to prospectively study the association between the plasma level of     alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.   "
112443|NCT01814137|"     This trial is conducted globally. The aim of the trial is to compare efficacy of insulin     degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD)     versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in     controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an     extension to trial NN5401-3941 (NCT01680341).   "
112444|NCT01814124|"     Femoroacetabular impingement (FAI) is recognized as a formal source of hip pain and     disability typically affecting the young adult, active population and has been identified as     a precursor to hip osteoarthritis (OA). Common impairments include sharp, anterior groin pain     in a position of hip flexion limiting patients' ability to tolerate prolonged sitting,     squatting, stair climbing, etc. resulting in both work limitations and decreased social     participation. Manual therapy and exercise is known to be effective in reducing pain and     increasing physical function in the management of hip OA. To the extent that FAI is often a     precursor to developing hip OA, logic would seem to dictate a manual therapy plus exercise     approach to decrease pain and disability and potentially prevent or delay osteoarthritis     related surgery. Currently, surgery is considered the first line of treatment with respect to     FAI. However, there is a lack of evidence to support or refute the use of conservative     treatment interventions in this patient population.      This study is designed to investigate the benefits of physical therapy interventions (manual     therapy and exercise) over usual care for improving pain and physical function in patients     with FAI of the hip. For this study, 52 participants will be recruited from the Department of     Orthopaedic Surgery, Wake Forest Baptist Medical Center, for an outpatient consultation for     consideration of hip arthroscopy surgery. Participants will include those patients who meet     clinical and radiological criteria for formal diagnosis of FAI. Participants will be     randomized into two treatment groups. Participants in one group will receive usual care plus     manual therapy directed at the hip as well as a supervised exercise program and home exercise     program twice weekly for six weeks. Participants in the usual care group will receive usual     care as prescribed by the physician. Changes in pain, physical function and benefits of the     intervention will be assessed over six weeks. Should this research study demonstrate     treatment effectiveness of physical therapy intervention in patients diagnosed with FAI of     the hip, manual therapy plus exercise may have the potential to delay or prevent surgery in     this patient population. Further, to the extent to which FAI has been shown to lead to later     development of hip OA, effective treatment interventions may help to delay or prevent     secondary osteoarthritis related changes as well as total joint replacement surgery     associated with hip OA. This study will provide preliminary data that can be used to prepare     further grant applications designed to determine the safest, most effective treatments for     patients with FAI.   "
112448|NCT01814072|"     The overall objective of the proposed research is to use an innovative methodological     framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an     optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI)     for obesity. MOST involves highly efficient randomized experimentation to assess the effects     of individual treatment components, and thereby identify which components and component     levels make important contributions to the overall program effect on weight loss. This     information then guides assembly of an optimized treatment package that achieves target     outcomes with least resource consumption and participant burden. Because the intervention     strategies being tested minimize in-person coaching and leverage technology that participants     already own, the new optimized intervention, to be called Opt-IN, will be more scalable than     traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant     progress in the fight against obesity.   "
112449|NCT01814059|"     Background:        -  Eosinophil-associated gastrointestinal disorders (EGID) are a group of related disorders          that affect the esophagus, stomach, and bowel. There are two major types of EGID,          eosinophilic esophagitis and eosinophilic gastroenteritis. They are caused by the body's          immune system being activated by food allergens, which then damages the gut wall. People          with EGID have large numbers of eosinophils (a type of white blood cell) in their gut.          EGID can cause difficulty swallowing, abdominal pain, or nausea.        -  At present, there are no drugs specifically approved to treat EGID. Most adults who have          EGID receive steroid therapy to manage the symptoms. However, long-term steroid use may          cause other problems in the body. Researchers want to see if low-dose sirolimus can be          used to treat EGID. Sirolimus is a drug used to prevent rejection of transplanted          organs. It may be able to keep the body's immune cells from being activated by food          allergens and decrease the eosinophils.      Objectives:      - To see if low dose sirolimus is safe and decreases blood or gut eosinophils in EGID.      Eligibility:        -  Individuals between 18 to 65 years of age who have EGID.        -  Participants must also have an elevated blood eosinophil count and positive blood tests          for IgE antibodies to foods.      Design:        -  Participants who are on medicine for EGID or related symptoms must be on a stable dose          for 1 month before screening and stay on that dose throughout the study.        -  Participants will be screened with a medical history and physical exam, and review their          symptoms. They will provide blood and urine samples. They will also have heart and lung          function tests. Some participants may have allergy skin tests.        -  At the first study visit, participants will have 2 days of inpatient tests. They will          repeat the tests from the screening visit. They will also have a full analysis of the          esophagus, stomach, and small intestine. On the second day, they will start to take          sirolimus as a liquid with orange juice or water.        -  Participants will continue to take sirolimus at home. They will record their doses and          any symptoms. They will also have a visit to provide blood samples about 2 weeks after          the first study visit.        -  At the second study visit (about a month after the first visit), participants will          repeat the tests from the screening visit. The sirolimus dose may be adjusted as needed.        -  Participants will take sirolimus for at least another 28 days. Depending on the dose of          the drug and the blood test results, some participants may need to take it for up to 112          days. Those who take the drug for a longer period will have additional study visits with          tests.        -  There will be another study visit when participants stop taking the drug. The last visit          will be a final follow-up visit.   "
112450|NCT01814046|"     Background:      - The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy     that involves taking white blood cells from patients' tumors, growing them in the laboratory     in large numbers, and then giving the cells back to the patient. These cells are called Tumor     Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200     patients with melanoma. This study will use chemotherapy to prepare the immune system before     this white blood cell treatment. After receiving the cells, the drug aldesleukin (IL-2) may     be given to help the cells stay alive longer.      Objectives:      - To see if chemotherapy and white blood cell therapy is a safe and effective treatment for     advanced ocular melanoma.      Eligibility:      - Individuals at least greater than or equal to 16 years to less than or equal to 75 years     who have advanced ocular melanoma.      Design:        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of          Health (NIH) clinical Center and undergo a history and physical examination, scans,          x-rays, lab tests, and other tests as needed.        -  Surgery: If the patients meet all of the requirements for the study they will undergo          surgery to remove a tumor that can be used to grow the TIL product.        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood          cells. {Leukapheresis is a common procedure, which removes only the white blood cells          from the patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the          hospital for about 4 weeks for the treatment.        -  Follow up: Patients will return to the clinic for a physical exam, review of side          effects, lab tests, and scans about every 1-3 months for the first year, and then every          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2          days.   "
112454|NCT01813994|"     Statins are commonly used as cholesterol-lowering medications and have shown effectiveness in     the primary and secondary prevention of heart attack and stroke. In addition, several recent     studies of human cancer cell lines and animal tumor models indicate that statins may have     chemopreventive properties through the arresting of cell-cycle progression. The     chemopreventive effect of statins was demonstrated in some kind of human tumors including     colorectal cancer. In addition, recent one large epidemiologic study showed that statins     decreased risk of gastric cancer. On the other hands, it has been well known that     Helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are     premalignant lesions of gastric cancer. Progression of these premalignant lesions could be     limited by H. pylori eradication. In addition, a recent double blind randomization study     revealed that simvastatin as adjuvant to standard therapy improves significantly the H.     pylori eradication rate. Therefore, investigators conjecture that statins may have an     adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the     role of statins in gastric carcinogenesis by observing the changes of gastric inflammation     under statins.   "
112455|NCT01813981|"     Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular     effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA),     however the level of CGA is reduced during the roasting process.      The aim of this study is to investigate the effect of coffee roasting on vascular response.     The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable     vascular response over more heavily roasted coffee due to the higher levels of CGA.   "
112456|NCT01813968|"     Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven     both in animal models and in humans. This study aims to investigate the effect of ischemic     postconditioning on postoperative hemodynamic function in a standard heart surgery patient     population.   "
112457|NCT01813955|"     Phosphodiesterase (PDE) inhibitors represent a new group of potential antipsychotic compounds     currently under development. One of these is papaverine, an inhibitor of the PDE 10 family.     The class of PDE10 inhibitors have been reported as possible candidates in the treatment of     schizophrenia, and may prove an attractive antipsychotic alternative due to the many     side-effects of the currently available antipsychotics. It has been proposed from preclinical     studies that PDE10 inhibitors have the potential to reduce cognitive deficits in     schizophrenia and these findings need to be confirmed in a human population, in view of the     fact that no other currently registered drug posses these unique properties.      The currently proposed project is designed to investigate whether the PDE10 inhibitor     Papaverine indeed have the capacity to reduce cognitive deficits in schizophrenia patients.     In order to accomplish this effect, Papaverine will be investigated in schizophrenia, with     regards to symptomatology, hemodynamic, neurocognition and early information-processing.   "
112458|NCT01813942|"     In order to perform research smoothly, the process of information extraction is required for     translating data in clinical text into available format for analysis and statistic. In     medical research, the problem of missing data occurs frequently. It is important to develop     the method with better imputation performance in the stability and accuracy. The purposes of     this project are to provide the data integration and extraction methods for handling the     structured and unstructured data sources in more efficient ways, to provide the validation     scheme for facilitating the data reviewing of extracted results produced by information     extraction modules, to increase the quality of clinical data by comparing the data from     different data sources and correcting data errors and inconsistent, to handle the clinical     data with the properties of time series and incompleteness, to increase accuracy of data     analysis and increase quality of health care by improving the completeness and correctness of     clinical data, to provide flexibility of methods in the platform. In the project, the disease     topic is focused on the liver cancer patients' clinical data and we hope the methods in the     projects can be extended to handle other diseases by replacing these knowledge models in the     future.   "
112459|NCT01813929|"     Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk     in type 1 diabetes (T1D). The purpose of this study is to measure the effect of metformin on     insulin sensitivity, vascular function and compliance, and mitochondrial function in T1D. The     long term goal is to identify novel non-glycemic approaches to managing cardiovascular     disease risk in T1D. The results of this study may validate a novel approach to T1D treatment     that could significantly improve current management of cardiovascular disease risk in this     high risk population.   "
112460|NCT01813916|"     The purpose of this study is to use the proteomic analysis of synovial fluid to perform the     comprehensive investigation of the biomarker that will be useful to assign the tratment     effectiveness of five weekly intra-articular HA injection.   "
112461|NCT01813903|"     The purpose of this study was to test internet and mobile-based applications to support     motivating lifestyle counseling to promote healthy eating habits of the mothers and their     spouses expecting first child. The feasibility of the intervention will be evaluated in the     pilot.   "
112462|NCT01813890|"     The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol     immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain,     compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.   "
112463|NCT01813877|"     It was previously shown that 18F-DOPA PET imaging results in intended management changes in     41% of brain tumor patients. However, its impact on patient outcome defined as survival,     costs, and/or quality of life has not been demonstrated. Regulatory agencies require     randomized trials to determine the impact of PET on patient management and outcome. In this     study we hypothesize that the addition of 18F-DOPA PET will improve patient outcome by more     accurately identifying presence or absence of tumor recurrence than conventional imaging.   "
112494|NCT01813474|"     The objective of this study will be to investigate the safety and tolerability of olaparib     tablet when given orally to Japanese patients with advanced solid malignancies. In addition,     the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.   "
112495|NCT01813461|"     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole     and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.   "
112464|NCT01813864|"     The proposed Quality Improvement Initiative study is a health services research project in     community-based substance abuse treatment programs. The primary goals are to use training and     technology transfer to match services to client needs, increase the number of services     received by clients, and improve client outcomes. This is a two phase study in which we     compare clients pre-intervention to clients post-intervention.      Clients from Phase II (Post-Intervention) compared to Phase I (Pre-Intervention) will:have     treatment plans that better match the problems reported at assessment; receive services that     better match their needs, as reported during the assessment/intake; show better results     during treatment performance on the Treatment Services Review (TSR), including attending a     greater percentage of their scheduled treatment sessions and increased satisfaction with the     Treatment Planning process; show better client outcomes at 3 month follow-up on primary drug     and alcohol measures, including Breathalyzer and urine drug screen, and secondary personal     health and social functioning measures such as days medical problems, days psychiatric     problems, days employed, days of conflict with family members, etc.   "
112465|NCT01813851|"     Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse     outcome and low quality of life in chronic renal failure patients treated by dialysis.     Treatment strategies of PEW by different types of nutritional support (as dietary counseling,     oral nutritional supplements or intradialytic parenteral nutrition) have limited efficacy.     Physical activity has been shown to have numerous positive impacts in pathologic conditions     associated to end stage renal disease.      Concomitant prescription of physical activity and nutritional support might mutually enhance     the anabolic effects of these interventions and improve the rate of remission of PEW.      The aim of this study is to analyze the effect of a programmed, progressive endurance     training performed during the dialysis session on a cycle ergometer under the supervision of     a qualified trainer, on protein energy wasting and physical functioning of chronic     hemodialysis patients.   "
112466|NCT01813838|"     A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute     myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not     responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response:      Patients will receive 6 treatment cycles unless disease progression, transformation, or     unacceptable toxicity occurs, or the patient refuses to continue participating in the study.      Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients     demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of     Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until     progression.   "
112468|NCT01813812|"     This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III     clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the     non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic     gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets,     three times a day for two weeks.   "
112474|NCT01813734|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the drug is being studied.      It has been found that some people with NSCLC have a change (mutation) in a certain gene     called the RET gene. This mutated gene may help cancer cells grow. Only participants with a     RET mutation will be allowed to participate. In this study, investigators are testing the     strategy of using a study drug designed to inhibit or shut off growth signals that results     from the mutated RET gene.      Ponatinib is an anti-cancer drug that has been used in research studies for other types of     cancer. Ponatinib blocks several growth signals in cancer cells, including RET. In this     research study, investigators are looking to see whether ponatinib is effective and safe in     treating NSCLC harboring RET rearrangements.   "
112496|NCT01813448|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)     of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will     also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in     healthy Japanese and Caucasian subjects.   "
112497|NCT01813435|"     After a stent procedure, it is common practice to prescribe anti-platelet medication to     prevent the blood from clotting. The main objective of this study is to determine if there is     a better medication strategy to prevent blood from clotting and at the same time minimising     the number of complications.      There are two medication strategies:        -  Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month,          and then ticagrelor alone for another 23 months OR        -  Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or          clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely   "
112475|NCT01813721|"     This is a prospective observational study investigating how physicians assess the risk of     febrile neutropenia (FN) developing in patients who will receive chemotherapy.      Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and     Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell     lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast     cancer and will be due to receive one of the specific chemotherapy regimens of interest.      Investigators' approach to FN risk assessment will be studied using lists of possible risk     factors they may consider during their assessment. Investigators will be asked to select and     rank the factors they consider the most important when assessing the overall FN risk of a     subject and when making the decision whether to treat with granulocyte-colony stimulating     factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based     initially on their own routine clinical practise and subsequently relating specifically to     each subject recruited.      This is a non-interventional study that involves no procedures outside normal care for the     subjects; all data collection will be completed prior to chemotherapy administration.   "
112476|NCT01813708|"     200 type 2 diabetes patients will be randomly submitted to an intensive life-style or a     collaborative educational programmes by means of random numbers list. The intervention will     be conducted by certified nutritionists or certified diabetes educators, previously trained     in behavioural modification and in self-care techniques. The intervention will last 16 weekly     sessions and A1c, LDL cholesterol, blood pressure will be measured as main variables.     Furthermore, body weight and abdominal girth, other lipids (HDL cholesterol,     triglycerides),and physical activity, quality of life, psychological well-being and     self-efficacy will be measured with specific questionnaires for up to 6 months.   "
112477|NCT01813695|"     The purpose of this study is to see if testing for genes related to pain and pain management     before surgery affects how patients are treated for pain after surgery. The investigators     want to know if this information will be used to effectively treat patients for pain after     surgery if the clinical staff have a chance to review it before the surgery.   "
112478|NCT01813682|"     The purpose of this study is to determine whether iron-fortified TPN is effective in the     preventative and treatment of preterm infants. Preterm infants are at risk for anemia     especially in preterm infants. Generally the smaller Birth weight and gestational age the     higher anemia rate in infants. About 25% to 85% of preterm infants develop evidence of anemia     during infancy，77% VLBW（very low birth weight） infants developed anemia during the hospital     stay. The effects of iron deficiency are pervasive and involve multiple organ systems. Poor     physical growth, gastrointestinal disturbances, thyroid dysfunction, altered immunity and     temperature instability has been attributed to iron deficiency in very low birth weight     infants. So it is important to provide iron for preterm infants.      As enteral nutrition is not feasible soon after birth in most preterm infants, Parenteral     iron administration is an efficacious method for us to select. For most preterm infants the     use of TPN(total parenteral nutrition) is very common during the first ten days of life, so     we hypothesis that iron-fortified TPN may have a preventative and treatment effect on preterm     infants using TPN as a supplementation of oral nutrition; Iron-fortified TPN(total parenteral     nutrition) can also improve iron store status of preterm infants. The higher concentration of     iron used in this study the larger preventative or treatment effect on preterm infants     anemia; It is safe to add Small dose of iron agent to TPN.   "
112479|NCT01813669|"     The purpose of this study is to examine whether an integrative group-based intervention will     help children experiencing psychological and physical distress. Children, ages 10 to 12, will     be recruited for participation in this therapeutic group. Eligible and consenting     participants will be randomized to a wait-list control group or the group intervention. The     group intervention will take place over a 12-week period, during which participants will     attend a weekly coping skills group that integrates yoga-based practices (such as yoga poses,     mindfulness, self-acceptance, breath work) with cognitive-behavioral principles (such as     increasing awareness of thoughts and emotions).   "
112480|NCT01813656|"     Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for     methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have     different pharmacological effects of neurotransmitters.To determine whether mirtazapine would     reduce methamphetamine use among mehtamphetamine addicts.   "
113403|NCT01801579|"     Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise.     The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it     appears important to know whether automatic assessment of ABI is as reliable and reproducible     as the manual method.   "
112481|NCT01813643|"     Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or     environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical     presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms),     response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic     neurotransmission) of both conditions. Both risperidone and aripiprazole are second     generation antipsychotics，but have different pharmacological effects of antipsychotic     treatment.This study was designed to examine the acute efficacy, safety, and tolerability of     risperidone and aripiprazole for patients with MAP.   "
112482|NCT01813630|"     A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.   "
112483|NCT01813617|"     Most patients respond to medical treatment with corticosteroids and immunosuppressive     treatment, but a majority of patients develop sustained muscle impairment. The aim of this     study was to evaluate the outcome of muscle endurance assessed with the Functional Index-2     (FI-2), muscle strength assessed by the MMT-8 and disease activity assessed by the six item     core set at 6 and 12 months following diagnosis in patients with polymyositis (PM) and     dermatomyositis (DM).      72 patients diagnosed with probable or definite PM or DM 2003-2010 who performed the FI-2 and     the MMT at the time of diagnosis were included in this Swedish Myositis Register study. All     patients had performed both the Functional Index-2 assessing muscle endurance and the Manual     Muscle test (MMT) assessing isometric muscle strength. Physician Global assessment based on     the evaluation of the consensus recommended six item core set for disease activity assessment     was also included. Data were analysed on group levels as well as with criteria for individual     responder criteria. A responder was identified as improving at least 20 % compared to     baseline.   "
112498|NCT01813422|"     This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab     (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78     than placebo in adults with coronary artery disease taking lipid lowering therapy.   "
112484|NCT01813604|"     This study is an open-label phase III randomized clinical trial that would compare     immunogenicity after receiving one of five different combinations of polio vaccines. Infants     will be enrolled and randomized at 6 weeks of age to one of five different arms:      A) Three doses of trivalent oral poliovirus vaccine (tOPV) at 6, 10 and 14 weeks of age B)     Three doses of bivalent OPV (bOPV) at 6, 10 and 14 weeks of age C) Two doses of intramuscular     (IM) inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age D) Two doses of     intra-dermal (ID) fractional IPV (f-IPV) at 6 and 14 weeks of age E) Sequential     administration of ID f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age To assess     the immunogenicity of each study vaccine and vaccination schedule, antibody titers against     poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before     (at 6 weeks of age) and after receiving 3 doses of study vaccine (18 weeks of age).     Seroconversion will be defined as a titer 4-fold higher than the expected fall in maternally     derived antibodies, assuming a half-life of 28 days. The initial antibody titer at 6 weeks of     age will be used as the starting point for the expected decline in maternal antibody.      This study will compare the immunogenicity of:        1. Sequential dose of intra-dermal f-IPV and bOPV to bOPV alone administered at 6, 10 and          14 weeks of age        2. tOPV to bOPV administered at 6,10 and 14 weeks of age        3. IM IPV to ID f-IPV administered at 6 and 14 weeks of age The answer to these questions          will guide the global polio eradication program in designing new routine immunization          schedule for children that eliminates the risks of paralysis due to vaccine derived          poliovirus (VDPV) from type 2 vaccine poliovirus.   "
112485|NCT01813591|"     This small study is to investigate the efficacy of Acthar in the treatment of chronic     migraine in patients who have failed multiple treatments, including Botox (which is defined     as having <30% reduction from baseline in the number of headache days per month). Despite the     widespread use of anti-seizure medications, there remain a significant number of patient     whose migraines are refractory to these agents. The pathophysiology of migraine is such that     the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are     released at the trigeminal nerve endings innervating the large cranial and dura mater blood     vessels and this neurotrasmission generates migraine associated pain. Because of this,     treatment for migraine can be directed towards down regulating those receptor sites     accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to     inhibit the release of CGRP and may also provide relief through a negative feedback loop as     exogenous ACTH inhibits CRH release and mast cell degranulation.   "
112486|NCT01813578|"     The hypothesis is that intensive aerobic and endurance muscle training is safe and beneficial     in patients with systemic sclerosis and concurrent interstitial lung disease.      The purpose of the study is to examine the effect of an eight week intensive aerobic exercise     and muscle endurance training program for patients with systemic sclerosis and 50-100 % of     forced vital capacity.      A single subject experimental design with repeated systematic measures during a six week     A-phase (baseline period) and an eight week B-phase (intervention period) was used. Physical     capacity (six minute walk test), aerobic capacity (submaximal treadmill test) and muscle     endurance in shoulder and hip flexion (Functional Index 2) are assessed every other week     throughout the 14 week study. Activity limitation (Health Assessment Questionnaire), quality     of life (Short Form 36), Raynaud, Fatigue and Global Health during the recent week (Visual     Analogue Scales) are assessed at weeks 0, 6, 14. The exercise program includes aerobic     exercise corresponding to 15 on the Borg RPE scale (strenuous) and muscular endurance     training three times/week.   "
112487|NCT01813565|"     The purpose of this study is to evaluate efficacy and safety of additional hyaluronic     acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with     interstitial cystitis.   "
112488|NCT01813552|"     This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or     omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and     tolerability of the study drugs when administered alone and in combination in healthy     participants.   "
112490|NCT01813526|"     Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based     medical food will be evaluated for 42 days.   "
114323|NCT01789463|"     Multicenter randomised study, on parallel groups to compare recovery of functional amplitude     following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the     other group.   "
112491|NCT01813513|"     The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food     on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK     interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK     of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus     low-fat meals on the PK of IDX719.   "
112492|NCT01813500|"     The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are     chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium     difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A     and B and is increasing faster in IBD patients, than the general population. Clinically, CDI     in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to     severe life threatening colitis, colectomy and death.      This pilot study will look at the relationship between IBD and this variable host immune     response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the IBD     population than in the general population. In the general population, high antitoxin titers     have been linked with colonization and low antitoxin titers with recurrent disease. The     investigators hypothesize that patients with IBD will have a lower Clostridium difficile     colonization and will have lower antibody titers than the control group. Additionally those     with lower titers will have an increased risk of developing CDI.      In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool     study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls).     In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to     controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate     the incidence of CDI in patients with IBD compared to controls and associations with     anti-toxin titers.   "
112493|NCT01813487|"     The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in     combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.   "
112499|NCT01813409|"     The ACR Rheumatology Clinical Registry (RCR) is a tool developed to assist members in     practice improvement, local population management, and efficient, successful participation in     national quality programs. RCR integrates evidence-based quality measures aimed at improving     care and drug safety for patients with rheumatoid arthritis, osteoarthritis, osteoporosis,     gout and juvenile idiopathic arthritis.   "
112500|NCT01813396|"     First, the purpose of the first year study will examine the joint capsule/muscular and     shoulder physical activity hypotheses related to ROM deficits as well as functional     disability in subjects with Stiff shoulders. Second, the purpose of the second and third year     study will investigate the long-term effect of 12-week joint mobilization, 12-week joint     mobilization plus soft tissue mobilization/massage, and 12-week joint mobilization plus soft     tissue mobilization/massage with appropriate shoulder physical activity guide on subjects     with Stiff shoulders. Subjects: First year: thirty subjects with Stiff shoulders will be     recruited. Second and third years: forty-five subjects with Stiff shoulders for one year     follow-up. Methods: For the measurement outcomes; functional disability, rotation range of     motion, joint mobility, muscle stiffness, and shoulder physical activity will be measured by     self-reported Flexi-level Scale of Shoulder Function or performance-based motion analysis,     goniometer, uni-axis load cell and electromagnetic tracking sensor, myotonometer, and     accelerometers, respectively.   "
112501|NCT01813383|"     Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical and     clinical behaviour as patients with HLA-DR3-DQ2 haplotype.   "
112502|NCT01813370|"     The purpose of this study is to continue follow-up on patients who were treated on the study     called TAX 3505 (MSK IRB #07-101). The sponsor of this study, has decided to end the study     early, before all patients have completed all planned follow-up tests. As a result, the     investigators do not yet know whether hormonal therapy alone, or in combination with     docetaxel, is better at preventing prostate cancer recurrence in patients who had a rising     PSA after prostatectomy. This study will continue following patients according to a schedule     that is similar to that found in the TAX 3503 (MSK IRB #07-101) study in order to answer that     question. This study is known as a registry study. The patients' will not receive any     treatment as part of this study. Instead, they will be asked to have a blood test performed     once every 12 weeks.   "
112503|NCT01813357|"     This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with     placbeo in HIV positive people who are at intermediate cardiovascular risk.      It is possible that HIV positive people will receive a greater benefit from statins because     of their higher baseline levels of inflammation. Current Australian guidelines recommend     initiation of statin therapy on the basis of cholesterol level and the presence of other risk     factors for heart disease (such as diabetes) but do not take into account whether a patient     is infected with HIV. This study aims to determine what benefit HIV infected people will     receive from starting statin therapy earlier then currently recommended.   "
112504|NCT01813344|"     Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens     for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with     high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment     outcome of hyper-CVAD in LBL has reported only in small number of patients from single     institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based     treatment in LBL.   "
112505|NCT01813331|"     ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the     adherence to the current therapeutic guidelines in a large series of patients affected with     chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart     failure among all the patients referring to the ambulatory cardiologists of the healthcare     district.   "
112506|NCT01813318|"     Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused     on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability     that commonly occur in persons with ASD. Despite over two decades of significant     pharmacotherapy research, to date no medication has been shown in controlled trials to     enhance the core social deficits of ASD. Based upon findings describing the neurobiology of     ASD combined with our preliminary results, we believe the novel drug acamprosate will show     evidence of reducing social skills deficits associated with ASD.   "
112507|NCT01813305|"     The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with     diabetic foot ulcers.   "
112508|NCT01813292|"     HIV+ patients are considered at risk for excessive bone fragility. Several factors could     contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D     deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is     used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as     TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine     (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone     formation by stimulating osteoblasts, of often impaired bone quality.      The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal,     bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than     60 months. The patients will be randomly selected, then matched according to age, ethnic     origin, BMI.   "
112519|NCT01813149|"     40 CRPS patients will be recruited over a three-year period (target of 160 patients at all     sites). Assessment of exclusion criteria will be undertaken during initial recruitment.     Exclusion criteria are: <18 years; a second chronic pain syndrome that would interfere with     pain rating; psychiatric comorbidity; pain in both hands or feet; pregnancy or breastfeeding;     sympathectomy in the affected limb; use of topical medication; known sensitivity to alpha 1-     adrenoceptor agonists or other contraindications. Patients will maintain their regular oral     medications throughout the study period.      Assessment of sympathetically maintained pain (SMP) will require an intradermal dose of     Phenylephrine to rekindle SMP and mechanical hyperalgesia. Clonidine will be used to control     for affects of lgometer iction and may inhibit SMP by inhibiting the release of more     norepinephrine from sympathetic nerve terminals. Skin biopsies will be obtained under sterile     conditions from a site of mechanical or thermal hyperalgesia using a 3mm diameter skin biopsy     punch under local anesthesia. Samples from a mirror image site on the contralateral body side     will also be taken.   "
112509|NCT01813279|"     Systemic sclerosis is an autoimmune disease characterized by skin lesions and visceral     responsible for significant morbidity. Microcirculatory disorders and tissue fibrosis are     excessive severity of the disease. This condition can affect the hands with a major     functional consequence severely impairing the quality of life of patients.      Adipose tissue is used in plastic surgery for over a century for the filling of depressions     in the skin. In addition to the volume effect, a trophic effect on the surrounding tissue was     noted. It is shown that the stromal vascular fraction is responsible for this regenerative     effect.      In a previous study the investigators have demonstrated in a mouse model that the     subcutaneous adipose tissue provides a trophic effect on SSc skin lesions by reducing the     fibrosis of the dermis and providing a pro angiogenic.      Objectives and means:      This is a clinical study evaluating an innovative cell therapy procedure. The objective of     this study was to evaluate the effects of injection of autologous stromal vascular fraction     of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United     Kingdom) in digital in patients with scleroderma cutaneous hands.      Eleven patients with scleroderma with the hands will be included in the study. Due to the     nature of the orphan disease, a longitudinal study be conducted, where each patient will have     own control.      The evaluation will be pre and post operative for a period of six months. This evaluation     will be based on clinical criteria (trophic balance, functional) and laboratory     (capillaroscopy, Doppler ultrasound of the arteries of the forearm, laser-Doppler tissue).      Project schedule and implementation phases:      The project will run over a period of twelve months. Patients will be followed for a period     of six months. Analyzes clinical, paraclinical, and exploitation of results will be achieved     over a period of six months.      Expected Results: This study will validate the functional and trophic effects of reinjection     of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients     with scleroderma.      Conclusion: This innovative cell therapy could represent an alternative treatment for     patients with scleroderma in check, intolerant or insufficiently relieved by medical     treatment currently available in the scleroderma hand   "
112510|NCT01813266|"     Although infection with the hepatitis C virus (HCV) can result in acute hepatitis; it more     commonly progresses to chronic hepatitis. The acute process is most often asymptomatic. Acute     HCV typically leads to chronic infection. Chronic HCV infection is usually slowly     progressive. Approximately 5 to 20 percent of chronically infected individuals develop     cirrhosis over a 20-30 year period of time. Chronic HCV is the most common cause of chronic     liver disease, cirrhosis, hepatocellular carcinoma, and the most frequent indication for     liver transplantation in the United States.      Screening for chronic HCV infection is crucial because chronic HCV infection is often     asymptomatic, effective treatment is available, and untreated disease carries a high risk of     morbidity and mortality. Expert opinion, recommendations, and guidelines for HCV screening do     not all agree. All guidelines recommend screening patients at increased risk for HCV (ie:     typical risk factors). In 2012, the Centers for Disease Control and Prevention (CDC)     recommended screening all persons born between 1945 and 1965. At least two studies suggest     that screening persons born between 1945 and 1964 or 1946 to 1970, respectively, is     cost-effective. The studies estimated that if patients found to be HCV positive were treated     with pegylated interferon, ribavirin, and direct acting antiviral therapy (for patients with     HCV genotype 1), it would cost $35,700 to 37,700 per quality adjusted life-year. Screening     based upon a birth cohort in patients without risk factors may lead to more false positive     results.      Currently only 1 % of patients in the birth cohort of 1945-1965 who cared for by     Intermountain Healthcare providers have been screened. Ambulatory care physicians are not     effectively screening patients. It is unclear whether screening based on risk factors alone     versus screening based upon risk factors and birth cohort most effectively manages the burden     of chronic HCV infection for patients managed by Intermountain Healthcare providers. It is     possible that the Intermountain Healthcare population differs in risk from the U.S.     population,making guideline application less certain.      A well-designed prospective cohort study is needed to understand the risks and benefits of     different HCV screening strategies on diagnostic yield and clinical outcomes.      The investigators hypothesize that screening based on a person's history of risk factors will     detect chronic HCV infection in 2.7 % of the population tested; this would be according to     national average. The investigators further hypothesize that screening based on birth cohort     and risk factors will identify roughly the same percentage in the tested population. The     investigators anticipate usable data within three months which should give us data to     describe and publish the effectiveness of different screening strategies.      The investigators will identify patients with chronic HCV infection through this initial     study who now require treatment and management. The investigators believe this group could be     followed inexpensively for clinical endpoints for many years. This would then definitively     define the effectiveness of screening strategies based on good evidence. No study has     evaluated clinical outcomes associated with the different screening strategies for chronic     hepatitis c virus infection.   "
112511|NCT01813253|"     This study will evaluate overall survival of nimotuzumab in combination with irinotecan     compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or     gastroesophageal junction cancer.   "
112512|NCT01813240|"     Spinal cord trauma and the consequent paraplegia are possibly among the most devastating     injuries in soldiers and during spine surgery, and are significant in the medical, social and     financial aspects. Limited mobility, the need for assistance in all human activities, shame,     and many medical complications related directly to the neural deficits make paraplegia an     important target for prevention. Our study will evaluate the efficacy of Minocycline in two     different groups:        1. Minimizing the neurological damage among trauma patients.        2. Preventing neurological damage through operation in spinal tumors patients.      2.OBJECTIVES      The primary objectives of the trial are to determine:        1. Efficacy of administrating minocycline in minimizing the neurological damage among acute          spinal cord injury patients and spinal cord tumors (primary and metastases) patients?        2. Efficacy of administrating minocycline at changing the natural history and          rehabilitation of spinal cord trauma patients.        3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?   "
112513|NCT01813227|"     The purpose of this study is to evaluate the safety and effectiveness of an investigational     study drug called carfilzomib. The investigators want to find out what effects, good and/or     bad, it has on patients and their cancer if treatment continues beyond previous carfilzomib     treatment study.      Carfilzomib (KyprolisTM) is approved by the U.S. Food and Drug Administration (FDA) to be     used only in certain U.S. patients with relapsed and refractory multiple myeloma that have     tried and failed other therapies. It has not been approved to be used for any other disease     or condition.      In this study, carfilzomib is referred to as an investigational study drug because it is not     approved for use in all patients with multiple myeloma in the United States, and it is not     approved by some regulatory authorities (the agencies that are responsible for approving the     use of a medicine in a country such as Health Canada).      Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found     within cells that has the important role of identifying and marking damaged proteins that are     needed to be destroyed by the cell for survival. The inhibition of the proteasome allows for     damaged protein to accumulate within cells. This accumulation of damaged protein causes the     cell to die.   "
112557|NCT01812655|"     Relief of severe burn wound care pain may require both medications to relieve pain and     non−medication interventions,such as distraction. Little is known about distraction's     effectiveness. Virtual reality may be an effective distraction. The aims of this study are     1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction,     compared to passive distraction (PD) by watching a movie, and usual care (SC) that is     provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to     determine the relationship among anxiety, desire for distraction, and engagement with     distraction on the pain.   "
113503|NCT01800253|"     The study proposes to investigate whether acute total deprivation affects metabolism as     measured through blood and peripheral tissues. Its aim is also to investigate how acute total     sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance     and aspects of appetite regulation.   "
112514|NCT01813214|"     This study is for patients with malignant melanoma which has spread beyond the local area and     cannot be surgically removed, and who have melanoma tumors that are accessible for repeat     biopsies. This research study is a way of gaining new knowledge about treatment options for     metastatic melanoma. This research study is evaluating the effects of the drugs vemurafenib     and cobimetinib on the immune system.      Vemurafenib has been approved by the FDA for treatment of patients with advanced melanoma     that harbors a B-RAF mutation. Vemurafenib works by blocking a protein called B-RAF.     Researchers have found that a large number of melanomas have mutations (changes) in the BRAF     gene. Genes are specific parts of your DNA that contain information on hereditary     characteristics such as hair color and eye color. The BRAF gene codes for a protein called     B-RAF, which is involved in sending signals in cells that can lead to cell growth. Research     has determined that mutations in the BRAF gene at the V600 position cause a change in the     B-RAF protein that can drive the growth and spread of melanoma cells.      Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2,     central components of the RAS/RAF pathway.      The purpose of this research study is to determine how vemurafenib and cobitmetinib may alter     the immune system's reaction to melanoma, in order to learn how best to combine immune     therapies with vemurafenib in the future.   "
112515|NCT01813201|"     The purpose of this clinical trial is to determine whether intermittent administration of     testosterone against placebo is associated with a reduction of mortality and heart failure     hospitalizations at 1 year, in male patients with advanced heart failure and testosterone     deficiency.   "
112516|NCT01813188|"     The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the     use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for     the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone     graft.   "
112517|NCT01813175|"     This study is initiated to investigate the effect of infant formula with added specific     synbiotics mixture on proportion of beneficial bacteria.   "
112518|NCT01813162|"     The purpose of the study is determine if the local release characteristics and systemic     exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by     concomitant use   "
112520|NCT01813136|"     The objective of this study is to determine the feasibility of pazopanib treatment     interruption with reintroduction at progression in iodine refractory progressive     Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous     administration.   "
120841|NCT01704196|"     The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving     the number of subjects that achieve abstinence from cocaine and reducing cocaine use in     subjects with cocaine dependence.   "
112521|NCT01813123|"     This study is designed to develop and test a gender-specific, web-based drug abuse prevention     program. Study participants will be adolescent girls aged 13 and 14 years who will complete     all measures online. Randomly assigned girls will also interact online with a skills-based     program and subsequent annual booster sessions.      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower     among girls assigned to receive the intervention.   "
112522|NCT01813110|"     The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate     inflammatory responses to endotoxin challenge.   "
112523|NCT01813097|"     Patients with prostate cancer should have the following examination including biopsy, serum     PSA volume, prostate CT scan or MRI, bone scan, abdomen ultrasound, chest X ray, blood     biochemistry, blood rout, ECG and testosterone.      Two groups:      First group:30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal     prostate implant +Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection     1/4weeks).      Second group: 30 cases should be treated with Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg     subcutaneous injection 1/4weeks).      PFS and PSA level will be the primary variables.   "
112524|NCT01813084|"     RV1729 is a new medicine being developed for possible treatment of asthma and smoking related     lung disease (also known as chronic obstructive pulmonary disease - COPD).      The main purpose of this study is to investigate the safety, tolerability and     pharmacokinetics of single and repeat doses of RV1729.   "
112525|NCT01813071|"     This is a research study about an experimental (investigational) oral Shigella sonnei     (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which     causes bloody, watery diarrhea. Infants and children living in developing countries     experience the greatest consequences of this disease. The purpose of this study is to find a     dose of the vaccine that is safe, tolerable, and develops an immune response. About 39     healthy adults, ages 18-39, and 48 healthy children, ages 5-9, will participate in this     study. Once the vaccine is proven safe and tolerable in adults, then it will be tested in the     children. This study will require volunteers to stay in the research facility for several     nights for the first dose; they will not be required to stay overnight for the second and     third doses. Participants will be assigned to receive 1 of 3 vaccine dose levels by mouth.     Study procedures include: stool samples, blood samples and documenting side effects.     Participants will be involved in study related procedures for about 8 months.   "
112526|NCT01813058|"     Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant     blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a     synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to     extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial     and orthopedic surgery. In this prospective randomized double-blinded study, the     investigators wish to evaluate the hypothesis that TXA is more effective than standard of     care at decreasing blood loss and blood transfusion perioperatively in children and     adolescents undergoing idiopathic scoliosis surgery.   "
112558|NCT01812642|"     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores     what the body does to the drug) of JNJ-37822681 in participants with stable schizophrenia     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often     with delusions and hallucinations, and withdrawal into the self).   "
112559|NCT01812629|"     The study objective is to assess the growth, tolerance and efficacy of a complete amino     acid-based medical food in children with chronic diarrhea.   "
124455|NCT01656707|"     The purpose of this study is to examine an Adaptive Treatment approach in order to improve     outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.   "
112527|NCT01813045|"     Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible     for cardiovascular disease. In this proposal, the investigators intend to build upon a highly     successful programme of studies exploring the cardiovascular applications of positron     emission tomography. Specifically, the investigators will explore the potential role of a     novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and αvβ5     integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and     remodelling. This tracer has been successfully used to assess angiogenesis in metastatic     tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here     propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases,     specifically acute myocardial infarction and aortic atherosclerosis. The investigators will     correlate 18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis. If     successful, this novel radiotracer could provide an extremely important non-invasive method     of assessing in vivo angiogenesis, plaque vulnerability, and tissue remodelling as well as     potential applications in developing stem cell therapies.   "
112528|NCT01813032|"     Emergency Service Professionals have an increased risk of death from heart attacks when     compared to the general public. All the emergency professions share similar responsibilities     such as emergency call-outs and shift work. Heart disease is the commonest cause of on-duty     death amongst fire-fighters accounting for 45% and compared with 22% in police officers and     15% in the general population. The unique risk to fire-fighters is likely to reflect a     combination of factors including extreme physical exertion, mental stress, heat and pollutant     exposure.      In this study the investigators will assess healthy career fire-fighters and age-matched     healthy police officer control subjects following a sedentary period. The investigators will     take blood samples to measure platelet activity (platelets are the particles in blood that     help blood clot) and will examine how blood clots outside of the body. The investigators will     then perform studies placing small needles in the arm to assess how the blood vessels respond     following these duties. The investigators hypothesise that fire-fighters do not have     pre-existing impairment of heart, blood or blood vessel function as a cumulative effect of     their occupation, but rather these are acute and transitory effects following distinct     fire-fighter duties. We therefore expect similar results in both occupational groups.   "
112529|NCT01813019|"     The purpose of this study is to determine whether AFQ056 as an add on therapy to SSRIs can     have beneficial effects by reducing the total score of Y-BOCS (Yale and Brown Obsessive     Compulsive Scale) in OCD patients resistant to SSRI treatment (failed SSRI over 12 weeks at     appropriate doses).   "
112530|NCT01813006|"     Background      Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad     cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease     even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated     fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease,     however its effect on patients with FH is not known.      The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to     inflammation measured in the blood and the effect on the blood vessels`ability to relax     (endothelial function) by means of tonometry.      Hypothesis      Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the     endothelial function, and the treatment will also lead to a decrease in in several markers of     inflammation and in lipids in the blood.   "
112531|NCT01812993|"     Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke     (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce.     Several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled     randomized sequential phase studies currently exist that aim to establish the efficacy of     early non-invasive ventilation in AIS patients. The main hypothesis for this study is that     early non-invasive ventilation with automated bilevel positive airway pressure (auto-BPAP)     positively affects short-term clinical outcomes in AIS patients. This is a multicenter,     prospective, randomized, controlled, third rater-blinded, parallel-group trial. Patients with     AIS with proximal arterial obstruction and clinically suspected sleep apnea will be     randomized to standard or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated     within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and     nocturnal sleep. Patients will undergo cardiorespiratory polygraphy between day 3 and 5 to     assess sleep apnea. The primary endpoint is any early neurological improvement on the NIHSS     at 72 hours from randomization. Safety, tolerability, short-term and 3 months functional     outcomes are assessed as secondary endpoints by un-blinded and blinded observers     respectively. This study will provide data to power a subsequent phase III study.   "
112532|NCT01812980|"     The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in     HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic     reactions to the vaccine will also be assessed.   "
112533|NCT01812967|"     The investigators hypothesize that the physiological effects of milk on satiety and glycemic     control are mediated by the interaction between its macronutrient components by both     insulin-dependent and independent mechanisms.   "
112534|NCT01812954|"     This study is health economic analysis of medicinal treatment options for moderate-to-severe     psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes     will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for     moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various     different sources, including summary of product characteristics (SPCs) and the German S3     guideline on psoriasis care, health care utilization data and official statistics.      The study aims to investigate the comparative cost-effectiveness of biologic and conventional     systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe     plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled     (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as     well as indirect cost will be considered.   "
112535|NCT01812941|"     The purpose of this project is to evaluate the level of mitochondrial dysfunction several     patient populations: Burn, trauma, and control group of healthy volunteers.      Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory     mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction     syndrome in severly injured patients.      As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial     dysfunction.   "
112536|NCT01812928|"     Flexible cystoscopy has diagnostic as well as therapeutic role in many patients presenting in     urology clinic with lower urinary tract symptoms (frequency, nocturia etc) and hematuria     (blood in urine).      Pain associated with cystoscopy varies from patient to patient, majority requires local     anesthesia or lubricant solution only. During flexible cystoscopy, lubrication, use of     topical anesthesia and duration of cystoscopy are recognized as important factors     contributing in severity of pain of which use of intraurethral gel left to individual     preference. Various studies are available reporting the pain perception with use of various     intraurethral gels. Even the highest level of evidence is unable to resolve the query.      With this study the investigators hypothesize that pain perception (recorded in form of pain     score) during flexible cystoscopy can be reduced with use of per operative diclofenac(Non     Steroidal Anti Inflammatory Drug)suppository in comparison to plain gel alone.      With better control of pain the investigators aim to increase patient comfort and compliance     which will increase the patient satisfaction rate and early return to work.   "
112537|NCT01812915|"     When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff     hyperinflation of the endotracheal tube. Furthermore the difference among various types of     cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.      TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the     intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with     cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical     study is needed to evaluate the intracuff pressure during general anesthesia with nitrous     oxide exposure.   "
112538|NCT01812902|"     Prostate cancer is currently the second most common cause of cancer death in men in Western     countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and     is classically indicated in intermediate and high risk prostate cancer patients and is held     at the same time of prostatectomy. A traditionally pelvic lymphadenectomy covers the     obturator chain bilaterally. Recently, some studies have demonstrated the existence of lymph     node involvement outside the traditional boundaries of classical lymphadenectomy,     recommending therefore extended dissection; this also includes the external / internal /     common iliac chains and presacral. Thus lymphadenectomy, according to these authors, would     also has a therapeutic role, besides helping in better staging. Although some retrospective     studies report an association between lymphadenectomy and tumor progression, the exact impact     of extended lymphadenectomy in oncological outcome of patients with prostate cancer is not     clearly established, mainly by lack of prospective randomized studies on the subject . The     study objectives are to compare the oncologic results of extended lymphadenectomy versus     limited in order to elucidate the role of extended dissection in lymph node staging and     results of treatment in terms of increased tumor cure. The investigators also intend to     identify patients who may benefit from oncologically extended procedure. To do this, the     investigators will evaluate prospectively patients diagnosed with prostate cancer at     intermediate or high risk indicating lymphadenectomy and radical prostatectomy. These     patients will be randomized to the extended versus limited lymphadenectomy and the     investigators will compare the lymph node metastasis and pattern of spread of prostate     cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis     and cancer-specific survival.   "
112539|NCT01812889|"     The purpose of this study is to determine the safety, local tolerability and pharmacokinetic     parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females     following single dose administration (Part 1), and in nonpregnant women with vaginitis     following multi-dose administration (Part 2).   "
112540|NCT01812876|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in December 2012.      It was funded by China major scientific and technological specialized project for     'significant new formulation of new drugs'.      The purpose of this study is to make a cohort event monitoring to see whether and how     Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.   "
112542|NCT01812850|"     The purpose of this study is to assess temporomandibular joint (TMJ) symptoms and night     muscle activity in an objective manner, in addition to daytime bruxism and clenching, as     reported by the patient, following the start of orthodontic treatment with Invisalign®. A     baseline evaluation of all measures will be used as control data, while different time points     will be used to evaluate the evolution of patients' symptoms over the course of six months     (the duration of the study).   "
112543|NCT01812837|"     The global aim of this study is to investigate how microneedles can facilitate the     penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses      The specific aims are as follows:        1. Investigate whether pretreatment with microneedles enhances penetration of topical          aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA          pharmaceuticals Inc.        2. Investigate whether pretreatment with microneedles can decrease the required incubation          times of the topical ALA prior to exposure to blue light photodynamic therapy.   "
112544|NCT01812824|"     This study is to examine the effectiveness of a health communication system (Gabby) that     assesses preconception health risks and tailors the intervention to each subject, based on     her health risks.      There is a need to develop practical tools that can be used to identify preconception health     risks and will facilitate the initiation of intervention for these risks; this project     specifically targets young Black or African American women in order to reduce major     disparities in birth outcomes. Clinicians do not have time to assess for over 100     preconception health risks that can impact birth outcomes; this system can streamline that     assessment and create a personalized list of risks. Patients can then share their list with     clinicians to make their healthcare visits more effective.      This study involves a pilot of the system through the Preconception Peer Educator (PPE)     Program, which is a program created by the Office of Minority Health. The program began in     historically black colleges in the United States, with the purpose of training students to     reach out to their community to educate about the increased risk of preterm birth, low birth     weight and infant mortality among African Americans. The PPEs teach about preconception     health, or getting healthy before pregnancy, to increase the chances of having a healthy     baby. Now the PPE program has expanded to colleges in over 20 states across the country.   "
112545|NCT01812811|"     The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2     diabetic patients who had two 24 hour measurements performed within one week with the     Arteriograph24 equipment.   "
112560|NCT01812616|"     An open-label phase to assess the frequency and severity of adverse events in recurrent     glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part     A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B).     Part B will be reported here.   "
112561|NCT01812603|"     An open-label phase to assess the frequency and severity of adverse events in recurrent     glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part     A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B).     Part A will be reported here.   "
112546|NCT01812798|"     An important gap in the management of peanut allergy is that we do not know the threshold     dose, below which most peanut allergic individuals will not react. There is likely a spectrum     of reactivity to peanut where some individuals react to trace doses, whereas others are able     to tolerate larger doses. The purpose of this study is to determine the minimum threshold     dose needed to cause a mild objective reaction when peanuts are consumed by peanut-allergic     individuals in a carefully controlled clinical setting. 30 peanut-allergic participants aged     7-65 years will undergo a two-day, double blind placebo controlled food challenge.     Participants will be gradually fed increasing amounts of peanut, or placebo, until objective     allergic symptoms are observed. Statistical modelling of individual threshold doses will be     used to determine a population threshold dose, or a level of peanut to which 90% of the     peanut-allergic population will not react. Knowledge of threshold doses at an individual and     population level is valuable in that it provides critical information for the management of     peanut allergy by individuals, their caregivers and health professionals, as well as     knowledge of allergen risks to public health agencies and the food industry.   "
112547|NCT01812785|"     The goal is to improve the evidence-based management of fever cases seen in outpatient     clinics in malaria endemic countries, through a better understanding of the value of accurate     malaria diagnosis, and through an improved understanding of the other causes of fever in     children. The objective is to describe systematically (as much as possible) the etiologies of     fever in children in an urban and in a rural environment of sub-Saharan Africa.   "
112548|NCT01812772|"     RESEARCH QUESTION Do ureteric stents with tethers, left in-situ for 1-2 weeks, increase the     rate of stent bacterial colonization, urinary bacterial colonization and stent related lower     urinary tract symptoms compared to stents without tethers?      HYPOTHESIS We hypothesize that ureteral double-J stents with tethers increase the rate of     stent bacterial colonization, but do not increase the rate of urinary bacterial colonization     or stent related lower urinary tract symptoms compared to stents without tethers when left     in-situ for 1-2 weeks.   "
112549|NCT01812759|"     The goal of this clinical research study is to learn if fentanyl nasal spray can help     decrease pain related to cancer when used with other drugs for pain. Researchers also want to     know if this drug can help decrease the length of your stay in the Emergency Department.      In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is     not a drug. It looks like the study drug but it is not designed to treat any disease or     illness. It is designed in this study to be compared with the study spray to learn if the     study spray has any real effect.      You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you     decide not to take part in this study.   "
112550|NCT01812746|"     The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with     metastatic castration-resistant prostate cancer (mCRPC).   "
112551|NCT01812733|"     The objective of the non-interventional study is to compare the quality of life, health care     resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq)     versus oxycodone and laxatives for patients with severe pain, and to evaluate the     cost-effectiveness of treatment with Targiniq.   "
112552|NCT01812720|"     This phase II trial studies how well carfilzomib and dexamethasone work in treating patients     with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth.     Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and     increase blood cell counts. Giving carfilzomib together with dexamethasone may be an     effective treatment for multiple myeloma.   "
112622|NCT01811797|"     This is a prospective, randomized, double-blind clinical study comparing safety and efficacy     of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)     device - Renova on symptomatic ED patients to the safety and efficacy of the control sham     patients.   "
112553|NCT01812707|"     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein     convertase subtilisin/kexin type 9 (PCSK9).      Primary Objective of the study:      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels     after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL     (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.      Secondary Objectives:        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment          in comparison with placebo        -  To evaluate the safety and tolerability of alirocumab        -  To evaluate the development of anti-alirocumab antibodies        -  To evaluate the pharmacokinetics of alirocumab   "
112554|NCT01812694|"     Background:      - LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is     studying pregnant women who are overweight or obese. It is looking at ways they can manage     their weight gain in pregnancy and how this may affect them and their babies health at birth     and through the first year. Researchers want to recruit pregnant women who are being treated     at the Phoenix Indian Medical Center. They will participate in a two-part study.      Objectives:      - To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical     Center.      Eligibility:        -  Pregnant women at least 18 years of age who are overweight or obese.        -  Participants must be receiving care at the Phoenix Indian Medical Center.        -  Participants must be having only one child in their pregnancy (no twins or other          multiple births).      Design:        -  This study will have two parts. The first part will have three visits to obtain data          about health early in pregnancy. It will also let participants and researchers find out          if the participants are eligible and should continue in the second part of the study. In          the second part, participants will be monitored throughout their pregnancy and during          the first year after the baby s birth to test the effects of a lifestyle intervention to          control weight gain during pregnancy.        -  On the Part 1 study visits, participants will have a physical exam and medical history.          They will provide blood, urine, hair, and other samples to be examined for possible          genetic conditions.        -  For the Part 2 study visits, participants will be placed in one of two treatment groups.          Each group will receive the same prenatal and postnatal care that they would get if they          did not join the study.        -  The first group will have a lifestyle intervention program. They will spend about 2          hours every week with other members of their group to learn diet and activity behaviors          that may help with their health.        -  The second group will have an enhanced care program. They will be given additional          information about health and pregnancy and be invited to attend three classes to learn          about staying healthy during pregnancy.   "
112555|NCT01812681|"     Experimental and observational studies have shown that vitamin D deficiency may be associated     with an increased risk for non-bone diseases and/or abnormal development for the other     systems of fetus. The aim of this study is to determine the relationship between cord blood     25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities     including RDS, PDA, NEC, BPD AND ROP in preterm infants.   "
112556|NCT01812668|"     This pilot clinical trial studies cabozantinib-s-malate in treating patients with     hormone-resistant metastatic prostate cancer. Cabozantinib-s-malate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth   "
112563|NCT01812577|"     Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and     after the procedure. During the procedure patients need deep sedation and cannot be     collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to     evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can     provide anesthesia and post-operative analgesia in these patients.   "
112564|NCT01812564|"     The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth     factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring     injuries.      The hypothesis is that the time to return to sport is shorter in the patient group treated     with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in     comparison with 2 control groups:        -  the patient group treated with Platelet Poor Plasma (PPP) injections in combination with          exercise therapy (control injection AND usual care).        -  the patient group treated with exercise therapy (usual care)   "
112565|NCT01812551|"     Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000     individuals worldwide, including about 3,800 in Italy -- is often associated with low bone     mineral mass. The current aggressive therapies have ensured a much longer survival of CF     patients but this has led to a higher frequency of osteoporosis and bone fractures, a serious     problem which not only affects quality of life, but also hinders further therapeutic     measures.      The aim of this study, conducted on a large group of children, adolescents and young adults     with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment with     RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility and     efficacy of alendronate treatment (for another year) in patients not responding to calcium +     25-OH vitamin D alone.   "
112790|NCT01809600|"     This retrospective study is aimed at evaluating the safety and efficacy of     rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or     high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large     B-cell lymphoma and BL.   "
112566|NCT01812538|"     This study is conducted to evaluate the effectiveness of DIC075V on ventricular     repolarization in healthy subjects compared to placebo after a single dose of DIC075V     administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the     baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular     repolarization in healthy subjects compared to placebo. Other secondary objectives are as     follows:        -  To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects          compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD).        -  To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between          the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations.        -  Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy          subjects.        -  Provide additional safety information.   "
112567|NCT01812525|"     Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no     inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of     hospital stay will be analyzed.   "
112568|NCT01812512|"     People with heart failure (HF) are hospitalized over a million times a year in the US at a     cost over $39 billion dollars. About half of the patients are readmitted within 30 days.     Despite a number of institutional reforms, cost and readmissions remain high in the VA. The     VA Home Telehealth (HT) monitoring program decreases preventable readmissions, but HF     readmissions remain increased in the VA. Despite an active and effective HT program, the     Charleston VAMC has the highest HF readmission rate in VISN 7. Though the HT program     introduces communication, self-management, and shared decision-making in initial training,     previous QUERI RRP evaluation identified lower than expected levels of specific communication     practices associated with the promotion of HF self-management and shared decision-making,     mediated by the requirements of the technology.   "
112569|NCT01812499|"     Inhospital the blood transfusion process consists of many phases: ordering the blood product,     analysis of the blood sample, delivery, transport and storage of the blood product and     administration. In each of these phases (near) accidents may occur. A severe transfusion     incident refers to the transfusion of a wrong blood product, whereas a near miss is detected     before transfusion.      In 2010 the University Hospitals Leuven introduced a new electronic patient incident report     system for transfusion events.      In this study the investigators will analyze the reported blood transfusion events to detect     the most common causes of blood transfusion events and the weakest link in the blood     transfusion chain.   "
112570|NCT01812486|"     A randomized clinical trial was initiated to investigate whether a reduction of the dose to     the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a     reduction of acute and late side effects without compromising tumor control.   "
112571|NCT01812473|"     The purpose of this study is to investigate the influence of hypoalbuminemia on the protein     binding characteristics of the antifungal drug voriconazole in ICU patients.   "
112572|NCT01812460|"     We want to test the hypothesis, that resistance training by the use of weigth cuffs on the     angle can prevent loss or improve the strength of the quadriceps muscle in COPD patients     admitted to hospital due to an exacerbation. The training is started at day one of admittance     and the strength of the quadriceps is measured by a portable dynamometer.   "
112573|NCT01812447|"     EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the     safety and long-term effectiveness of the Spiration Valve System in patients with emphysema.      Patients appropriate for the EMPROVE study are those who are currently on medical treatment     but still symptomatic.      EMPROVE also accepts α-1 antitrypsin deficiency patients.   "
112574|NCT01812434|"     Hypothesis 1: Treatment of heart transplant recipients with sildenafil, a PDE-5 inhibitor,     will improve small artery elasticity (SAE) when compared to placebo.      Hypothesis 2: PDE-5 inhibition will improve endothelial function, resulting in increased     production of nitric oxide, reduced activation of circulating endothelial cells, and     increased endothelial progenitor cells.   "
112599|NCT01812096|"     Intravenous injection is the standard administration route of bortezomib; however,     subcutaneous administration is an important alternative. We want to compared the     pharmacokinetic of subcutaneous versus intravenous bortezomib at the approved 1•3 mg/m2 dose     and twice per week,on days1, 4, 8 and 11 of 21-day cycles, schedule in newly diagnosed     patients of multiple myeloma.   "
112575|NCT01812421|"     Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are     asked to participate in our pre specified hypertension health education protocol (HHEP) after     discharge from our hospital.HHEP was used as secondary prevention treatments of stroke and     cardiovascular diseases.      HHEP consists of several items such as controlling the patient's hypertension level,     monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension     like tobacco smoking, obesity, and motivating the patient to physical activity and to a     healthy diet.      Patients will receive visits by a study nurse with the aim of supervising, monitoring, and     recording the adherence of HHEP. The patients will be classified as different adherence level     at the end of the study according to their adherence condition.      This study is aimed at testing the hypothesis that controlling hypertension and its risk     factors was more effective than those do not receive HHEP in reducing the recurrence of     stroke and cardiovascular diseases.   "
112576|NCT01812395|"     New devices and techniques are coming into use everyday. Ultrasonic dissectors (UDs) are such     new devices which is a practical alternative to the usage of scalpel and sutures. UD's cause     overheating of neighboring tissues in an area of 1 to 3 millimeters. Due to the generated     heat UDs might cause nerve injury. The investigators would like to see if usage of UDs during     thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional     thyroidectomy.   "
112577|NCT01812382|"     This feasibility study will allow for the determination of the in vivo recovery and time of     dialysis to optimize a future thorough microdialysis study. This is a single session, open     label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects.     Three healthy subjects will be enrolled and complete the study procedures. Subjects will be     admitted to the research unit on Day 1 and three microdialysis probes will be placed in the     thigh of each subject prior to the start of the microdialysis procedure. After normal saline     solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes.     Saline perfusion will occur during the washout period. Microdialysis sampling will be done     for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection     will continue every 30 minutes for 4 hours. The approximate duration of study including     follow-up is 4 days.   "
112791|NCT01809587|"     The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating     the bowel movement frequency   "
112578|NCT01812369|"     Radical cystectomy remains the gold standard treatment for invasive non metastatic     transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival     rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in     patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with     lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been     developed in order to improve these results. Thanks to randomized trials and meta-analysis,     it can be concluded that perioperative chemotherapy increases overall survival with an     absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined     tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen     to be delivered are not yet determined. Meta-analyses have shown that the benefit is only     observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of     gemcitabine and cisplatin are delivered since this combination has been shown to yield a     similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate,     vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown     to be associated with higher response rates than MVAC in bladder metastatic disease, also a     better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators     therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in     term of progression-free survival in patients for whom chemotherapy has been decided, before     or after radical cystectomy. Secondary endpoints include overall survival, side effects,     response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and     cisplatin sensitivity. The total number of patients projected is 500. The number of patients     is based on the median progression-free survival rate of 50% at 3 years observed in patients     treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10%     (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim     analysis is planned after the occurrence of 174 events. With an estimated uniform accrual     rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is     expected to occur 8 years after the start of the trial.   "
112579|NCT01812356|"     The aim of this study is compare the surgical convenience and early and long-term outcomes of     cryomaze procedure using nitrous oxide with using Argon gas.      The investigators will analyze the pathologic findings of atrial tissue after cryoablation     using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation     burden 3 months and 1 year postoperatively and atrial activity will be checked.   "
112580|NCT01812343|"     Estimate the response of ankle to brachial pressure index to incremental maximum exercise in     subjects free from prior cardiovascular disease.      Estimate morbi-mortality of included patients over a 5 years follow up.   "
112581|NCT01812330|"     The purpose of this study is to compare the efficacy and safety of ticagrelor with     clopidogrel   "
112582|NCT01812317|"     Fire-fighters are at increased risk of death from heart attacks when compared to other     emergency service professionals whose jobs involve similar components such as emergency     call-outs and shift work. The unique risk to fire-fighters is likely to reflect a combination     of factors including extreme physical exertion, mental stress, heat and pollutant exposure.      In the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths     were classified according to the duty performed during the onset of symptoms or immediately     prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart     attack) occurred during fire-suppression whilst this activity represented a relatively small     amount of a fire-fighters professional time. Fire simulation training centers offer a unique     opportunity to assess the heart, blood and blood vessel response to fire suppression in a     controlled environment.      In this study the investigators will assess healthy career fire-fighters on two occasions:     following a fire-suppression training exercise in a purpose built real-fire training center,     and following a sedentary period as a control. The investigators will take blood samples to     measure platelet activity (platelets are the particles in blood that help blood clot) and     will examine how blood clots outside of the body. The investigators will then perform studies     placing small needles in the arm to assess blood vessel function following fire suppression.     By undertaking this comprehensive assessment of blood, blood vessel and heart function we     hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire     suppression. The investigators hypothesize that following the fire-suppression exercise     firefighters blood will clot more readily and their blood vessels will not relax properly     which are two of the main processes in the development of a heart attack.   "
112583|NCT01812304|"     This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on     a pelvic model is significantly better in terms of a technical skills scoring system compared     to frontal teaching.   "
112600|NCT01812083|"     The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene     polymorphisms may be associated with PLBW. Smoking has been well documented by numerous     studies as a major environmental risk factor for periodontitis and adverse pregnancy     outcomes. Therefore, the investigators only selected non-smoking individuals in this study as     the smoking-related risk could obscure the polymorphism-related increase in risk for     periodontitis and adverse pregnancy outcomes. This study aimed to determine the association     between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy     outcomes and periodontitis in a non-smoking Turkish population.   "
112584|NCT01812291|"     The study examines the efficacy of a stepped care approach for depressed diabetes patients     (first study objective). 256 patients with diabetes and comorbid subthreshold or clinical     depression will be randomly assigned to either a stepped care approach or a     treatment-as-usual condition. The stepped care approach consists of three treatment steps     comprising diabetes-specific cognitive-behavioral therapy (CBT) (group), depression-specific     CBT (single), and psychotherapeutic and/or psychiatric treatment (single). Patients assigned     to the stepped care approach will be treated stepwise until a clinically significant     reduction of depressive symptoms is attained or all three treatment steps are passed.      The primary outcome of the first study objective is a clinically significant reduction of     depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of     diabetes-related distress and improvement of well-being, health-related quality of life,     diabetes acceptance, diabetes self-care, and glycaemic control. Additionally, cost-benefit     analyses will be performed.      The second study objective is to analyse associations between diabetes, depression, and the     serum levels of inflammatory markers.      The third study objective is to analyse the courses of depressive conditions in diabetes with     regard to recovery rates and incidence of major depression.   "
112585|NCT01812278|"     The goal of this study is to determine whether the ACT website provides higher quit rates     than a current standard smoking cessation website.   "
112586|NCT01812265|"     This study will evaluate the pharmacological activity of PF-06305591 in healthy male     volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity     evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.   "
112587|NCT01812252|"     This randomized clinical trial studies different chemotherapies in treating patients with     myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a     donor stem cell transplant helps stop the growth of cancer cells in the bone marrow,     including normal blood-forming cells (stem cells) and cancer cells, and may prevent the     myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets.   "
112588|NCT01812239|"     A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal     Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.   "
112606|NCT01812005|"     This phase II trial studies how well alisertib with and without rituximab works in treating     patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Alisertib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as rituximab, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     carry cancer-killing substances to them. Giving alisertib with and without rituximab may be     an effective treatment for B-cell non-Hodgkin lymphoma   "
112589|NCT01812226|"     The aim of this study is to compare the predictive validity and reliability of PEth testing     at detecting alcohol use in post liver transplant patients. A prospective cohort study will     be used to test the primary hypothesis. Subjects enrolled in the study will be followed for     12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview     will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month     Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior     alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and     depression. The six and 12 months interview will focus on previous 30 day alcohol use. The     baseline, six and 12 months interviews will be conducted face-to-face at each site. While     many patients who receive a transplant do not live near the academic medical center that     performed the surgery patient, they normally have a transplant clinic visit 1-2 times per     year. Medical records and transplant databases will be assessed to assess the other variables     of interest.   "
112590|NCT01812213|"     To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the     ability to distinguish subjects with mild cognitive impairment (MCI) who progress to     Alzheimer's disease (AD) from those who do not.   "
112591|NCT01812200|"     Background:The acute coronary syndrome (ACS) is a complication of coronary artery disease     (CAD) and associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic     acid (ASA) with P2Y12 receptor antagonists such as clopidogrel is a cornerstone in the     treatment of patients with advanced CAD. Due to delayed onset of action, intersubject     variability or resistance to clopidogrel, different platelet aggregation inhibitors have been     developed. Ticagrelor is a reversible P2Y12 receptor antagonist with superior efficacy     compared to clopidogrel in the prevention of cardiovascular death in these patients.      Atrial fibrillation (AF) is also associated with thromboembolic events and substantial     mortality. Beside vitamin K antagonists (VKA, phenprocoumon) for stroke prevention in     patients with AF, the direct factor Xa inhibitor rivaroxaban and the direct thrombin     inhibitor dabigatran have recently received approval for prophylactic treatment of patients     with non-valvular AF.      However, there is a lack of efficacy or safety data for the combined impact of antithrombotic     drugs in patients requiring arterial and venous thromboembolic prophylaxis due to their     underlying co-morbidities.      Study objectives: To evaluate the effect of ticagrelor + ASA in combination with dabigatran,     rivaroxaban or phenprocoumon at steady state on markers of coagulation activation. The     effects on coagulation activation will also be studied after a single dose of dabigatran,     rivaroxaban or ticagrelor and at a therapeutic INR of phenprocoumon.      Study design: A single-centre, prospective, randomized, controlled, analyst-blinded study in     three parallel-groups. Subjects will receive ticagrelor + ASA in combination with dabigatran     (treatment A), rivaroxaban (treatment B) or phenprocoumon (treatment C). All IMPs will be     administered at doses indicated for stroke prevention in AF or ACS. Markers on thrombin     generation and platelet activation will be studied in venous blood where coagulation is in     resting state and in shed blood where the clotting system is activated in the     microvasculature in vivo: prothrombin fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT),     β-thromboglobulin (β-TG), D-Dimer, thromboxane B2 (TxB2), CD40 ligand (CD40L), p-Selectin.     Further, the endogenous thrombin potential (ETP), inhibition of factor Xa activity, activated     partial thromboplastin time (aPTT), prothrombin time (PT), Biophen® and Hemoclot® will be     assessed in venous blood.      Study population: A total of 60 healthy, non-smoking and drug-free male volunteers will be     enrolled in this trial and randomized into one of three balanced groups (treatment A, B and     C; n = 20 per group).      Main outcome variables: β-TG, F1+2 and TAT in shed blood      Additional outcome variables:        -  D-Dimer, TxB2, CD40L and p-Selectin in shed blood        -  β-TG, F1+2, TAT, D-Dimer, TxB2, CD40L, p-Selectin, ETP, aPTT, PT, inhibition of factor          Xa, Biophen® and Hemoclot® in venous blood      Risk/ benefit assessment:Total blood loss will be, dependent on treatment allocation, between     330 ml and 510 ml throughout the entire study period of 4 - 5 weeks. This amount of venous     blood is considered to be acceptable in this healthy population. Blood sampling procedures     may cause mild and transient pain. A minor haematoma may occur at the site of needle     insertions. Bleeding time incisions may leave small persistent scars. Administration of the     study drugs, in particular as triple combination for 5 days, results in transient     hypocoagulability and may cause overt or occult bleeding. The risk is considered low in the     healthy subjects under study. Continuous monitoring of safety parameters (haemoglobin,     haematocrit, platelet count, coagulation) and surveillance of the overall status will be     performed during study participation. Subjects will be instructed to avoid vigorous physical     exercise and handling of hazardous machinery during study participation. ASA, dabigatran and     rivaroxaban can cause gastrointestinal discomfort. Other side effects are rare.      The combination of these novel anticoagulants (dabigatran, rivaroxaban, ticagrelor) has not     been investigated so far. Conducting this study in a healthy population limits potential     bleeding risk reported from drug interactions and impaired liver or renal function, which may     influence the pharmacokinetics and -dynamics of the investigational products.      This study can provide information on haemostatic system activation in vivo during triple     treatment with antithrombotic drugs, which is indicated for patients with AF and ACS. The     results of this study may provide dosing guidance for risk reduction of patients with ACS and     AF.   "
112592|NCT01812187|"     The purpose of this study is to increase access for rural Veterans to evidence-based,     person-centered, individually tailored treatment for alcohol use problems. The primary aim is     to evaluate the acceptability and feasibility of using mobile technology deliver treatment     for alcohol use disorder. A mobile application will be used replacing the usual setting of     clinical visits that accompanies standard face-to-face CBT therapy. The application will be     loaded onto an iPod, which will be distributed to each participant that has been found to be     eligible to participate.   "
112593|NCT01812174|"     This study examines the hemodynamic and hemolytic properties of two additional smaller size     valves to the On-X line of valves already approved by FDA.   "
112594|NCT01812161|"     Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP),     androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the     Human chorionic gonadotrophin (HCG) stimulation test ，also，we hypothesize that EA is more     efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.   "
112595|NCT01812148|"     Review of the investigators hospital experience in cytoreductive surgery and hyperthermic     intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as     intraperitoneal chemotherapeutic agent.   "
112596|NCT01812135|"     A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and     immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant   "
112597|NCT01812122|"     The purpose of this study is to analyze the differences of blood sugar level and glycemic     variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number     of type 2 DM patients. The investigators also reveal influences of each drugs on     cardiovascular risk factors by measuring related biomarkers.   "
112598|NCT01812109|"     Testicular torsion is the spontaneous twisting of the testis and its blood vessels, resulting     in acute pain, vascular compromise and death of the testicle if unrelieved quickly. In this     study, investigators will test a near-infrared spectroscopy (NIRS) device that rapidly and     non-invasively measures deep tissue oxygen saturation.   "
112602|NCT01812057|"     The purpose of this study is to compare post-cesarean section consumption of pain medication     between two groups of patients undergoing scheduled cesarean section at term gestation who     receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo     at 24 hours after surgery. The hypothesis is that a single perioperative dose of     dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in     women having cesarean delivery under spinal anesthesia.   "
112603|NCT01812044|"     The purpose of this study is to determine if local anesthetic, either a subtenons injection     (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel     (applied directly on the surface of the eye) given at the end of strabismus surgery reduces     postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic     for pain at the end of strabismus surgery.   "
112604|NCT01812031|"     Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer     imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism.     In case of cancer, metabolism is, classically, increased and some hot spots are visible on     PET images. Because of respiratory motion some lung tumours (especially the smallest ones)     can be falsely interpreted by the clinician.      The investigators developed a respiratory-gated PET method in order to reduce the motion     issue. The investigators designed a study to investigate its effect on lung cancer (primary     or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the     lungs.      To that aim, patients presenting a lung nodule on a CT examination can be proposed to     participate this study. After the standard PET acquisition (acquired in free-breathing), an     additional 10 minutes respiratory-gated PET acquisition is performed without additional     injection. After that, a breath-hold (~10s) CT is performed.   "
112607|NCT01811992|"     Despite the marginal improvements in survival of patients suffering from malignant glioma     treated with gene therapy vectors, the clinical trials conducted so far using viral vectors,     in particular adenoviral vectors, have proven that the use of adenoviral vectors is a safe     therapeutic approach, even in large, multicenter, phase 3 clinical trials. Treatment of     malignant glioma using gene transfer modalities typically consists of surgical debulking of     the tumor mass followed by the administration of the viral vectors into the brain tissue     surrounding the tumor cavity. This study will combine direct tumor cell killing (TK) and     immune-mediated stimulatory (Flt3L) gene transfer approaches delivered by first generation     adenoviral vectors.   "
112608|NCT01811979|"     Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The     purpose of this study was to determine the effectiveness of local anesthetic eye drops and a     pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye     examinations for retinopathy of prematurity.   "
112609|NCT01811966|"     Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during     introduction of anesthesia.      The purpose of this study is to test the hypothesis that a defined preoperative volume     substitution compared to standard procedure will result in a reduced incidence of hemodynamic     instabilities during introduction of anesthesia in elective surgery patients.   "
112610|NCT01811953|"     Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two     strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and     bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets     empagliflozin and metformin under fed conditions (Part II).   "
112611|NCT01811940|"     The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of     the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine     dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The     proportion of participants achieving sustained cocaine abstinence for three consecutive weeks     at the end of the study will be significantly greater for the combined pharmacotherapies     group compared to the placebo group.   "
112612|NCT01811927|"     The purpose of this study is to the assess the clinical performance of the BIOTRONIK     PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary     arteries.   "
112613|NCT01811914|"     Focused transthoracic echocardiography (TTE) is a technique, which allows quick and     non-invasive diagnosis and monitoring in hemodynamic instable patients. There are preliminary     data supporting the hypothesis that TTE is feasible in the operating theatre.      The purpose of this study is to test the hypothesis that intraoperative focused TTE has an     impact on high risk patients´ management when it is added to standard extended monitoring     practices in hemodynamic instabilities.   "
112614|NCT01811901|"     In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered     after symptom onset - the better the outcome. This delay can be dissected into onset-to-door     time and door-to-needle time (DNT). SITS-WATCH aims to reduce median DNT in participating     centres.   "
112615|NCT01811888|"     This is a prospective, observational study, aimed to establish the relationship between an     inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the     probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous     analgesia efficiency will be measured during the month previous to surgery using quantitative     sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in     movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after     surgery.   "
112616|NCT01811875|"     Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma     inhibitor levels for at least 100 Exposure Days (EDs) for each subject.      Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and     adverse events   "
112617|NCT01811862|"     This is a prospective randomized controlled trial to obtain preliminary data for the design     of a future definitive efficacy study. A randomized controlled trial is needed because     comparison to historical data would be biased. The investigators will use sham acupuncture as     the control to account for effect from attention from and interaction with the therapist.   "
112618|NCT01811849|"     A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to     Humalog® in Subjects with Type 1 Diabetes   "
114324|NCT01789450|"     The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar     complex (NAC) prospectively due to the section of the dermis after decortication     (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.   "
112619|NCT01811836|"     Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc     homeostasis and environmental enteropathy (EE).      Specific -        1. To measure zinc status using a dual zinc stable isotope assay before and after          administering resistant starch (RS) in 20 children.        2. To measure intestinal function using a site-specific sugar absorption test before and          after administering RS in 20 children.        3. To determine the relationship between RS and zinc homeostasis.        4. To determine the relationship between RS and environmental enteropathy.   "
112620|NCT01811823|"     Prospective, open-labelled study which will enrol 360 participants in four groups of 80     participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults     without any evidence of TB; HIV-uninfected adults with concurrent microbiologic confirmed TB,     HIV-infected adults with concurrent microbiologic confirmed TB.      Participants will receive the recommended seasonal 2013 un-adjuvanted Trivalent Influenza     Vaccine (TIV). At 3 visits, blood will be collected for determination of immune responses.      Objective:      • To determine the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on     immune responses   "
112621|NCT01811810|"     The most common treatment for men with high risk prostate cancer is radiation therapy (XRT)     followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with     substantial metabolic, physical, mental and sexual side-effects. In this study, the     investigators propose a treatment strategy to optimize the control of high risk prostate     cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent     with docetaxel and adjuvant short-course AD. The investigators hypothesize that this approach     will be superior to the current standard of care and obviate the need for long term AD. In     this study, subjects will be randomized to either XRT with long term ADT or XRT and     chemotherapy and short term ADT.   "
112792|NCT01809574|"     We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients     would lead to a more accurate diagnosis and consequently alterations in treatment regimens     that may lead to improved outcomes.   "
112623|NCT01811784|"     Several human Nipah virus (NiV) outbreaks have occurred in Bangladesh since 2001with 71% case     fatality. Outbreak investigations have repeatedly identified drinking fresh date palm sap as     a risk factor for NiV transmission. Bats are the reservoir of NiV and infected bats can shed     virus through both saliva and urine and can contaminate the raw sap. The virus can transmit     to humans through ingestion of contaminated sap. To interrupt bats access to the sap, sap     harvesters (gachhis) occasionally use skirts make by local materials. These skirts have been     found to be effective to interrupt bats' access to the sap. As an indirect effect of the     community level skirt promotion, some people stopped drinking raw sap. When trees have     skirts, bats cannot access the sap and when people do not drink sap, they are at much lower     risk of contracting Nipah virus. The purpose of this study is to design, implement and     evaluate behavior change interventions to prevent human consumption of NiV contaminated sap     through reducing raw sap consumption from unprotected trees in a district of the NiV affected     regions in Bangladesh.   "
112624|NCT01811771|"     Background:      Vibrio cholerae is one of the major causes of severe diarrheal disease in Bangladesh. It is     estimated that there are about 450,000 cholera cases each year in Bangladesh. Cholera is     prevalent in both urban and rural settings in the country. Policy decisions about how best a     new public health tool can be incorporated into the system requires evidence. Investigators     have recently carried out a feasibility study of oral cholera vaccine in urban Dhaka in     Mirpur (Protocol #10061). However, whether a similar system can also be utilized in a rural     area in Bangladesh needs to be studied.      The hospital disease surveillance data from International Centre for Diarrhoeal Disease     Research, Bangladesh (icddr,b) reveals a substantial burden of cholera from Keraniganj     upazila. Investigators propose a feasibility study of oral cholera vaccination by using the     existing national immunization service delivery mechanism in Keraniganj. This study will help     to provide evidence for the policy makers in introducing oral cholera vaccine in preventing     cholera in high risk rural areas in Bangladesh.      Hypothesis:      That icddr,b in collaboration with the Government of Bangladesh will be able to implement an     oral cholera vaccine program that;        1. reaches residents of rural union of Keraniganj        2. reduces the incidence of diarrhea due to Vibrio cholerae      Objectives:        1. Carry out cholera vaccination in one rural union in Keraniganj.        2. Evaluate the impact of vaccination in reducing cholera in the study area      Methods:      Two unions in Keraniganj will be selected; around 30,000 individuals in one union will be     vaccinated and impact evaluated by comparison with another similar union. After vaccination,     passive cholera surveillance at the Upazila hospital will be conducted for two years on the     patients from the two unions.      Outcome measures/variables:      Cholera vaccination programme will be assessed by the number of doses administered, drop-out     rates between the two rounds, the proportion of vaccine wastage, and the vaccine coverage.      Proportion of diarrheal hospitalizations that are due to V. cholerae O1 between the     vaccinated and non vaccinated union will be calculated and compared to assess the impact of     intervention.   "
112625|NCT01811758|"     The investigators expect that a culturally specific group intervention targeting African     American smokers will result in greater smoking cessation rates compared to a standard     intervention.   "
112626|NCT01811745|"     The purpose of this study is to evaluate the efficacy and the possible mechanisms underlying     music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) in older people, compared     to multicomponent exercise training.      This study is designed as a 12-month, prospective, single-centre, single-blind, 2-arm,     parallel group, randomized controlled trial in which 140 community-dwelling older adults at     high risk of falls are randomly assigned to receive either a music-based multitask training     intervention (i.e., Jaques-Dalcroze eurhythmics) or a multicomponent exercise training     intervention, for 12 months. A 12-month follow-up is planned with outcome measures assessed     at three time points: baseline (before intervention initiation), 6-month (intervention     mid-point), and 12-month (intervention termination). Outcomes of interest include physical     and cognitive performances, and falls. In addition, the investigators specifically address     brain circuits in an exploratory sub-study. Volunteer trial participants from both study arms     are invited to undergo functional magnetic resonance imaging (fMRI) at baseline and 12-month.   "
112627|NCT01811732|"     This study was designed to evaluate the efficacy of delafloxacin patients with acute     bacterial skin and soft tissue infections (ABSSSI).   "
112637|NCT01811602|"     A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training     intervention led by a physiotherapist on urinary incontinence, quality of life and sexual     health in women who report urinary urgency and incontinence following surgery and radiation     treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).   "
112638|NCT01811589|"     Failure of ventricular catheters remains a significant problem in patients with     hydrocephalus. The purpose of this study is to determine whether the use of a simple     instrument assisted by a smart phone application software can achieve a more precise     placement of ventricular catheters than the standard free-hand placement technique.   "
112639|NCT01811576|"     The primary objective of this study is to evaluate the clinical effect of TV-1106.   "
112628|NCT01811719|"     An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This     randomized trial of an intervention to assess and prevent intimate partner violence during     pregnancy and the post-partum builds upon the David Olds model of nurse home visitation     (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be     effective in multiple settings in preventing child abuse and enhancing maternal and child     health and psychosocial outcomes. However, prior research has shown that the NFP intervention     is not as effective in homes where there is intimate partner violence (IPV). Although the NFP     by itself has reduced IPV in one setting, it has not in another. The proposed study will test     the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among     women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice     or empowerment model whereby women can choose among interventions related to her goal for her     current intimate relationship. If IPV or emotional abuse or controlling behaviors are     assessed, the intervention is based on two interventions shown to be effective in assessing     for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker     brochure driven intervention). For women desiring to enhance marital quality, the Markman and     Stanley PREP model that has been shown to enhance relationship quality will be offered. The     PREP model also has some preliminary evidence of preventing IPV. For women with other risk     factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child     abuse, substance abuse), community resource linkage (beyond referral) strategies as with the     NFP model will be used to obtain community resources to address these risk factors. 250 women     referred to the Multnomah County Health Department will be randomized to the experimental     (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule     during pregnancy and until the infant is 24 months old. The intervention will concentrate on     the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional     abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome     measurement (CTS2, WEB, TPMI, depression - Edinborough, & parenting stress), will occur at 3     months before delivery, 9 months & 21 months post-partum with multivariate MANOVA, SEM and     growth curve analyses.   "
112629|NCT01811706|"     Investigators expect there will be improvement in walking speed and steadiness after taking     Dalfampridine, thereby improving activities of daily living and enhancing social and     occupational functions for patients with spinocerebellar ataxia.   "
112630|NCT01811693|"     This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin)     administered by paramedics in the field within 2 hours of symptom onset to 45 severely     hypertensive stroke patients. The primary objective of the study is to evaluate the     feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in     achieving modest reduction of blood pressure. Patients with acute stroke will be identified     in the field by paramedics who have received training in basic and advanced cardiac life     support, stroke recognition, and specific procedures relevant to the proposed study.     Physician-investigators will obtain informed consent for each subject for study entry after     cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment     by applying transdermal GTN patch in the first two dose-tiers, and administering a single     sublingual GTN metered spray followed by application of the transdermal system in the last     dose tier. The sites involved in the study will be emergency medical services rescue     ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.   "
112631|NCT01811680|"     To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill     device devised by local engineers for subacute hemiplegic stroke patients for gait     rehabilitation. This is a phase 1 feasibility and safety trial on the above device for 10     chronic stroke patients with hemiparetic gait dysfunction to be conducted over a period of 2     months.      Research protocol and standardized outcomes measures will be used.   "
112632|NCT01811667|"     The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of     rapamycin (mTor) pathway plays a role on the development and the lymphatic-vascular     organisations.      The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.   "
112633|NCT01811654|"     The purpose of this study is to determine the safety and effectiveness of intra-articular     hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome     (PFPS) and determine if this treatment can provide incremental clinical benefits over     standard care for patients with this diagnosis.   "
112634|NCT01811641|"     Accumulating evidence suggests that early-life nutrition can affect metabolism and thus     increase the risk of disease in adulthood (e.g. type II diabetes and obesity). One possible     mechanism to explain these effects is epigenetic variation at critical periods of     development. Epigenetic variation describes non-inherited permanent alterations to an     individuals DNA.      Recent work in mouse models has demonstrated that maternal nutritional status can affect such     epigenetic processes such as DNA methylation and gene expression during embryonic     development, with profound effects on outcomes. The investigators aim to study these     processes in humans for the first time. The investigators will exploit the experiment of     nature setting in The Gambia, i.e. fluctuation in diet according to season. During the     'hungry' season diets are known to be depleted in nutrients required for epigenetic gene     regulation. Nutritional biomarkers in blood as well as the dietary intake will be measured in     pregnant women according to season. A blood sample will also be taken from babies born to     these women to determine whether there is a direct effect of diet on mothers' nutritional     status and hence variation in DNA methylation patterns in their babies by season.   "
112635|NCT01811628|"     The goal of this research study is to collect information from Latino and Hispanic smokers     and recent quitters about factors that are important to them when they are trying to quit.     Researchers want to better understand some of the challenges and problems that Latinos and     Hispanics face when they try to quit smoking, and then use that information to design a     treatment for future smokers.   "
112636|NCT01811615|"     Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing     plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.      Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study.     After screening and stratification by sex and papillary bleeding index (PBI), participants     were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX +     0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control);     (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3)     toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental     rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index     (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were     advised to brush their teeth as usual during the eight weeks study period. Additionally,     groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr.     Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks     after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for     statistical analysis.   "
112640|NCT01811563|"     The purpose of this study is to assess the differences in functional and patient reported     outcomes between total knee replacement (TKA) implants. In addition, this work will examine     the correlation between functional assessments and patient reported outcomes following     surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and     then one year following TKA. Subjects will complete a series of patient reported outcomes as     well as a series of functional outcomes at each of the time points of interest. The analysis     will include a repeated measures design to determine differences between groups across time     as well as correlations between the functional and patient reported outcomes. This work will     hopefully determine the importance of using objective functional outcomes following TKA as     well as determining the need for patient assessments out to one year following surgery.   "
112650|NCT01811433|"     The purpose of this study is to determine whether the Halo Index has utility in detecting the     difference between normal and non-normal recovery of patients in the first few hours     immediately following major inpatient surgery. A small but significant percentage of patients     who undergo major surgery will experience a major life-threatening complication in the first     30 days following surgery.      The chance of developing one or more of these complications increases with the size of the     surgery and with the severity of the patient's preexisting medical problems. It is unknown     whether fluctuations in a patient's vital signs and other measures of bodily function that     occur early in the recovery period are associated with postoperative complications. If this     is so, it may be possible to predict who is at increased risk for complications based on     monitoring during the early recovery period.      This study will make use of the Halo Index, a compilation of measures of patient functions     collected by non-invasive monitoring devices. In addition to heart rate, blood pressure,     temperature, and breathing rate, these include measures of dissolved oxygen in the blood, the     amount of hemoglobin in the blood, and other parameters.      Patients will have two additional non-invasive monitors attached during their stay in the     hospital post-anesthesia care unit (PACU). After the patient has been discharged from the     hospital, their medical record will be reviewed at two time points: The first will be soon     after discharge. Normal recovery patients will be defined as those who require only IV     fluids, pain medications and anti-emetic medications. Non-normal recovery will include those     who require transfusions of blood products, airway interventions such as a breathing tube,     blood pressure medications, or heart rhythm medications. The second chart review will occur     30 days after surgery. In this review, the presence or absence of the following events will     be ascertained: rapid response team calls, admission to the intensive care unit, infection,     pneumonia, the need for transfusion of 5 or more units of blood within a three-day period,     septic shock, the need for ventilation with a breathing tube, blood clot in the lung, kidney     failure, coma, stroke, heart attack, and death.   "
112641|NCT01811550|"     The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT):     Response to Insulin Administration and Blood Glucose Control proposal is designed to     accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III     multicenter, randomized, controlled trial planning to determine the efficacy and validate the     safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS     patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of     hyperglycemia control with intravenous (IV) insulin therapy or control therapy with     subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood     coagulation marker levels will be measured before and at 48 hours after the start of     treatment. Baseline and temporal changes in biomarkers levels will be compared between     treatment groups.      Hypothesis: The decrease in levels of markers of blood coagulation will be greater in     patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the     standard fashion.      Hypothesis: The decrease in levels of markers of blood coagulation will be greater in     patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity     adjusted measure of functional ability at 90 days after AIS).      Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels     and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for     hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood     coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ     Insulin-treated with or without favorable outcomes at 90 days after AIS.   "
112642|NCT01811537|"     Mitral prolapse is a common cardiac disease whose patients are at higher risk for serious     complications. Mitral valve (MV) repair offers several important advantages compared with     valve replacement and it achieves excellent midterm and long-term results. Two major problems     of using pre-measured expanded polytetrafluoroethylene(ePTFE) neochordae (the loop technique)     are deciding the length of the neochordae and tying the knot at the intended length.     Therefore, a great need still exists to find new method to simplify and precise the length of     neochordae. 20 patients with mitral valve prolapse who undergo mitral valve repair using     neochorda will be recruited in this study. Trans thoracic echocardiography (TTE) will be done     preoperatively for all patients. Two, three, and four chamber view of each patient will be     pre-operatively recorded. The device will be set with extracted measurements. Artificial     corda loops are made using CV-4 ePTFE sutures. After artificial chordae replacement, the ring     annuloplasty will be done. Follow up: A leakage test after attaching the 1st loop; Post     operative trans esophageal echocardiography (TEE) and determining the severity of mitral     regurgitation [Wall motion Score Index (WMSI), Mitral Annulus Area (MAA), LVEF, End Systolic     Volume (ESV), End Diastolic Volume (EDV), Iso-Volemic Relaxation Time (IVRT), (IVRT/(QE-QE^')     ,Chamber Relaxation velocity)/(Myocard relaxation velocity(E/E^' ), HR]; TEE 3 months after     discharge; Cross clamp time; Intubation period in ICU.   "
112643|NCT01811524|"     The main goal of the study is to present a framework, which integrates DNA, RNA and tissue     data to identify and prioritize genetic events that represent clinically relevant new     therapeutic targets and prognostic biomarkers for different kinds of brain tumors. The     investigators study the regulation of neoplastic cell growth by oncogenes, tumor-suppressor     and other cancer related genes using modern molecular genetic methods, such as     chromogenic-in-situ hybridization, comparative genomic hybridization (CGH), array-CGH, cDNA     microarray etc. In these studies the investigators utilize disease-specific tissue     microarrays (TMA) which the investigators have constructed since 1999. Until now up to 3000     different brain tumours have been sampled to our TMA:s. These permit high-volume simultaneous     analysis of molecular targets at the DNA, mRNA and protein levels. Research group has also     focused its interest on the neoplastic development of gliomas, particularly on their     hereditary and environmental factors.   "
112644|NCT01811511|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover     human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic     syndrome. The investigators measured decrement of body fat parameters, including Body Fat     Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their     blood pressure.   "
112659|NCT01811316|"     The purpose of this study is to evaluate the long-term efficacy and safety of lozenges     containing probiotics in reducing gingivitis. The primary purpose of this study is to support     claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.   "
112645|NCT01811498|"     The high-grade malignant brain tumors, glioblastoma multiforme (GBM), comprise the majority     of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive     behavior, resulting in median overall survival of only 9-12 months. Initial therapy consists     of either surgical resection, external beam radiation, or both. All patients experience a     recurrence after first-line therapy, so improvements in both first-line and salvage therapy     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently     used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in a     previous phase I trial that a single Superselective Intraarterial Cerebral Infusion (SIACI)     of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM.     Therefore, this phase I/II clinical research trial is an extension of that trial in that we     seek to test the hypothesis that repeated dosing of intra-arterial Bevacizumab is safe and     effective in the treatment of newly diagnosed malignant glioma. By achieving the aims of this     study we will also determine if repeated intra-arterial Bevacizumab improves progression free     and overall survival in newly diagnosed patients. We expect that this project will provide     important information regarding the utility of repeated SIACI Bevacizumab therapy for     malignant glioma, and may alter the way these drugs are delivered to our patients in the near     future.   "
112646|NCT01811485|"     The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and     50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin     monotherapy. This study was conducted to support registration of the fixed-dose combination     of vildagliptin and metformin for the treatment of T2DM in Japan.   "
112647|NCT01811472|"     The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as     assessed by MRI and to assess its safety and tolerability profile in subjects with     non-alcoholic fatty liver disease (NAFLD).   "
112648|NCT01811459|"     Background:      Delirium is an important problem in critical care. Its prevalence often reaches 75% in     intensive care patients. Its occurrence is associated with numerous complications and     deleterious consequences such as death, longer stay, higher cost, and long-term cognitive     impairment. Delirium treatment entails correcting its underlying causes and usually     initiating a pharmacological intervention with an antipsychotic. Typical antipsychotics,     particularly haloperidol, are commonly used to treat delirium although few placebo-controlled     trials of pharmacological treatments for delirium have been conducted. Furthermore,     appropriate doses for delirium treatment have yet to be established. In critical care, two     pilot studies provided the first randomized, placebo-controlled evidence for the     pharmacologic treatment of ICU delirium. One found that neither haloperidol nor ziprasidone     significantly reduced the incidence or duration of delirium compared with placebo whereas the     other one found that quetiapine added to as-needed haloperidol resulted in faster delirium     resolution.      Objective:      The goal of this study is to determine the effectiveness of antipsychotics in regular dosage     regimen (quetiapine group and haloperidol group) compared to as-needed haloperidol (placebo     group) in the pharmacological treatment of delirium. We will conduct a three-arm randomized     controlled trial to achieve this goal.      Materials and Methods:      During one year, 45 delirious patients from three intensive care units will be recruited and     randomized into one of three groups. Randomization will be performed in blocks of 9 by the     pharmacy department, using a random numbers table.      Patients will be continuously screened for delirium using the Intensive Care Delirium     Screening Checklist (ICDSC) as part of routine care. A positive screening score (≥4) will     warrant confirmation of delirium diagnosis by the treating physician. Treatment will begin     according to randomization group, provided that informed consent has been obtained. Delirium     status will be monitored during the episode using the Nursing Delirium Screening Scale     (Nu-DESC). When the Nu-DESC monitoring will become negative for delirium (total score below     2), the resolution of the episode will be confirmed by the treating physician. A clinical     evaluation by a psychiatrist will be performed within 24-48 hours of each of the two     evaluations made by the treating physician (beginning and end of the delirium episode).      The treating physician will initiate twice-daily treatment at the first of five levels for     each of the three groups: 1) 1 mg of intravenous (IV) haloperidol + oral (PO) placebo, 2) 50     mg of PO quetiapine + IV placebo, or 3) IV + PO placebo. Therapy will be titrated upwards on     a daily basis by increments of 1) 1 mg of IV haloperidol or 2) 50 mg of PO quetiapine, or 3)     IV + PO placebo every 12 hrs, respectively, if the subject received at least two doses of     as-needed haloperidol in the previous 24 hrs. As-needed (PRN) doses of 2 mg of IV haloperidol     q 30 minutes will be available to patients from all three groups and administered by nurses     until symptoms associated with delirium resolve. In case of unsuccessful as-needed treatment,     rescue (STAT) doses of 5 mg of IV haloperidol q 30 minutes will be available to patients from     all three groups and will be administered by nurses if agreement is reached with the treating     physician that the situation indeed calls for it. The treatment level of patients requiring a     STAT dose will immediately be raised to the above level. The treatment will stop when one of     the following occurs: (1) the subject is deemed by the treating physicians, based on their     clinical judgment, to no longer demonstrate signs of delirium and, therefore, to no longer     require scheduled therapy with an antipsychotic agent; (2) 21 days of therapy has elapsed;     (3) ICU discharge occurred; or (4) a life-threatening adverse event potentially attributable     to the study drug occurred that warranted discontinuation of the study drug.      Adverse effects will be closely monitored: extrapyramidal reactions, neuroleptic malignant     syndrome, drowsiness, hypotension, QTc prolongation. The treatment level of patients     presenting a non life-threatening adverse event will immediately be lowered to the level     directly below.      The sample size was calculated for a 2-tailed test with an alpha of .05 and a power of .80.      The primary statistical analysis will involve Cox proportional time to event analysis     comparing the three groups. Secondary analysis will use T-test comparisons for continuous     variables and chi square for proportional analysis.   "
112649|NCT01811446|"     The purpose of this study is to determine whether muscle activation can be accomplished more     effectively and comfortably in challenging subjects using novel configurations of an     activation device. A novel device will be compared side by side with a market leading device.   "
112651|NCT01811420|"     To evaluate the efficacy of a papain-based gel in caries removal.   "
112652|NCT01811407|"     Physical activity is known to help reduce obesity and the problems that accompany it. Walking     has many benefits that make it an excellent way for obese people to increase their physical     activity. It is hard, however, for people to stick with walking programs. Setting specific     and challenging walking targets that are combined with timely feedback about discrepancies     between desired and actual performance lead to higher performance. There is conflicting     theory and evidence about the effects of publicly announcing those targets on commitment to     the targets and on performance.      Our research question is whether public announcements reduce the challenge level of     commitments people set, and whether the reputational consequence of public announcements is     severe enough to increase performance. The investigators propose a controlled trial that will     integrate Facebook with the objective monitoring of walking via the use of pedometers to test     the effect of public announcements on commitments and step counts.      All participants will wear a pedometer and upload via the internet for 14 to 15 weeks,     depending on their date of randomization. The first 2 to 3 weeks the investigators will     determine the participant's baseline step counts. The following 12 weeks, the investigators     will recommend a daily step count target based on the median number of steps the participants     walked the previous week. Each week, participants will set a commitment by stating the number     of days in the following week that he/she will meet the computer-set step count target.      Commitments will be entered into an interface that will link with Facebook. Participants will     select who of their Facebook friends will receive their commitments and/or results via     Facebook posts. The interface will distribute those posts in a way that fits in with existing     online social practices.      There will be 3 experimental conditions. 1.) No public announcements 2.) Public announcement     of commitment and 3.) Public announcement of commitment and results. In addition, groups 2     and 3 will provide us with emails of 3 friends or family members who will act as the     participant's support team. The investigators will send announcements directly to support     team members.      The investigators plan to recruit 165 participants primarily by obtaining lists of     potentially eligible University of Michigan Health System patients from the clinical data     repository, and sending targeted letters to these patients. Because this research - and the     physical activity programs it will inform - aims to reach a large number of people     efficiently, enrollment will take place online with a click-through consent document. The     investigators have extensive experience with delivering online walking programs in similar     populations.      The investigators hope to learn best practices for using public announcements and online     social networks to encourage people to exercise more or to otherwise promote wellness.   "
112653|NCT01811394|"     The purpose of this study is to evaluate the safety and feasibility of primary     hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the     raster scan technique.   "
112654|NCT01811381|"     Physical exercise has proven to improve memory including in the elderly. Drugs developed to     stop the underlying disease processes that cause Alzheimer's disease may succeed only with     multimodal efforts to stimulate brain function. One purpose of the study is to test the     clinical benefits of curcumin, a safe and effective compound isolated from the turmeric root     (a component of Indian curry spices), which has been found to inhibit several potential     disease pathways in Alzheimer's disease. Another purpose of this study is to determine how     the addition of a physical exercise program in individuals with early memory problems may     affect memory function or brain imaging and blood-based markers associated with Alzheimer's     disease.   "
112655|NCT01811368|"     This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem     cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma.     Giving rituximab, antithymocyte globulin, and total-lymphoid irradiation (TLI) before a donor     peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop     the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled     monoclonal antibodies, such as ibritumomab tiuxetan, can find cancer cells and carry     cancer-killing substances to them without harming normal cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving rituximab,     antithymocyte globulin, and TLI before the transplant together with cyclosporine and     mycophenolate mofetil after the transplant may stop this from happening. Giving a     radiolabeled monoclonal antibody before a donor peripheral blood stem cell transplant may be     an effective treatment for non-Hodgkin lymphoma.   "
112656|NCT01811355|"     The purpose of this study is to determine if mexiletine is effective for the treatment of     muscle cramps in Amyotrophic Lateral Sclerosis (ALS).   "
112657|NCT01811342|"     Evaluate potential sources of error that affect the accuracy of continuous hemoglobin     monitoring.   "
112658|NCT01811329|"     Phase 1 of this study involves determining how consumption of dairy fat fractions rich in     milk fat globule membrane influences postprandial inflammation in participants with metabolic     syndrome or obesity during a high dietary fat challenge in a six-hour period.   "
112662|NCT01811277|"     This is an exploratory, single-armed, open label study on the efficacy and safety of     sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary     system or periampullary cancer or pancreatic cancer patients. The primary endpoint is     Objective response rate and secondary endpoint is progression free survival , overall     survival ,1 year survival rate and safety.   "
112663|NCT01811264|"     Through a patient participation aid (PPA) the investigators hope to improve the psychosocial     well-being of women diagnosed with metastatic breast cancer by empowering them to be active     participants in clinical encounters.   "
112664|NCT01811251|"     The aim of the study is to show a decrease in postoperative pain during the first     postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a     single dose of dexamethasone, pregabalin, or a combination of these two products.      Pain assessed by simple numerical scale will be also evaluated during the 48 first     post-operative hours.      Determining an optimal co-analgesic protocol through the results of this study could help     develop validation studies with larger scale such as a medico-economic component. In     addition, these study protocols are easy to apply (ponctual administration) and inexpensive.   "
112665|NCT01811238|"     Study Objectives:        1. Primary objective           - To assess the pain reduction after 8 weeks treatment from baseline (week 0)        2. Secondary objectives             -  To assess the pain reduction after 4 weeks treatment from baseline (week 0)             -  To assess the EQ-5D             -  To assess physician's overall satisfaction             -  To assess subject's overall satisfaction             -  To assess safety   "
112666|NCT01811225|"     Using two clinical models - pregnancy (Sample 1) and oral contraceptives (OC; Sample 2) - we     aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone     (Allo) and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology     during ad libitum smoking, and (2) determine the association between Prog, Allo, and E2/P     with the changes in smoking-related symptomatology and response to nicotine following     overnight abstinence   "
112667|NCT01811212|"     This phase II trial studies how well cabozantinib-s-malate works in treating patients with     thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth     of thyroid cancer by blocking some of the enzymes needed for cell growth.     Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to     the tumor.   "
112668|NCT01811199|"     Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy     patients.   "
112669|NCT01811186|"     Objectives:        1. Objective of main interest           - To assess the drop-out rate caused by adverse event* after 6 weeks treatment        2. Further objectives             -  To assess the drop-out rate caused by adverse event* after 1 week treatment             -  To assess the pain reduction rate after 6 weeks treatment from baseline             -  To assess the Euroquol (EQ-5D) quality of life             -  To assess physician's overall satisfaction             -  To assess subject's overall satisfaction             -  To assess safety   "
112670|NCT01811173|"     This study is intended to examine whether directed care of a nurse working jointly with the     patient's primary care physician, including a comprehensive assessment, creation of a     tailored care plan, proactive follow-up, self management support and caregiver support and     care coordination, can reduce hospital admissions for patients with multiple chronic     conditions.   "
112671|NCT01811160|"     Schizophrenia and bipolar disorder are frequently associated with an elevated risk for     obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic     disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute     and long term treatment of these disorders and are considered a first option on most     treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain,     disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality     as well as non- adherence to treatment. There are several hypotheses attempting to explain     the complex pathways that lead to antipsychotic therapeutic effects and their accompanying     adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent     the body weight increase, which indicates a possible role for biological rhythms in SGA     induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that     follows a circadian rhythm with an increased secretion in the middle of the night. This     hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and     periphery. Thus melatonin is involved in a series of biological functions such as sleep     regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more     recently in the regulation of metabolic processes including insulin, leptin, and lipid     regulation.      Given previous results in experimental animals, the purpose of the present study is to test     the potential effect of melatonin in reducing or preventing some of the metabolic     disturbances associated with SGA   "
112672|NCT01811147|"     The purpose of the study is to find out what parts of the brain have increased or decreased     activity and connectivity in individuals who have bipolar disorder, major depression, or no     history of mood disorder. Another purpose of this study is to use MRI images to determine     which young adults with major depression may be at greater risk for developing mild or more     severe symptoms of mania which suggests a diagnosis of bipolar disorder.   "
112673|NCT01811134|"     Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular     occlusion using detachable coils, with or without expendable stent assistance. A new     endovascular technique has recently been developed, using flow diverter stents without     associated coils. Clinical results already published are encouraging but have to be     confirmed. Furthermore, these medical devices are expensive in comparison to the coiling     strategy. The purpose of this study is to compare the clinical efficacy, safety, and     cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted     saccular intracranial aneurysms.   "
112688|NCT01810939|"     The purpose of this study was to evaluate the efficacy and safety of patiromer     (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study     also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic     treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer     treatment was also evaluated.   "
115248|NCT01777334|"     The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough     FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily     along with safety assessments in subjects with COPD.   "
112674|NCT01811121|"     Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases     per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is     based mainly on surgical excision as complete as possible followed by an additional     radiochemotherapy. The prognosis depends mainly on the quality of resection when it is     macroscopically complete. Different techniques to support the surgical resection have been     developed over the past 20 years. The reference technique is currently the intraoperative     neuronavigation for guiding excision by matching the intraoperative tumor boundaries with     those of the preoperative MRI. Its main drawback is the loss of precision during the     resection related to changes in anatomical limits of the tumor.      The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique to     support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by the     patient before surgery is captured specifically by the tumor cells and transformed into a     fluorochrome revealed intraoperatively by a light source length adapted wave with a set of     lenses included in the microscope. Resection is thus guided by this fluorescence whose     disappearance translates complete tumor resection.      Its interest is twofold:        -  Increase the percentage of complete tumor resection.        -  Improve disease-free survival and overall survival. The objective of the study is to          compare the FGS to the intraoperative neuronavigation for the resection of glioblastoma,          on a medical and economical level through a randomized, prospective, multicenter trial.      The annual number of patients likely to benefit of this technique in France is estimated at     2200 new cases.   "
112675|NCT01811108|"     Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to     31/12/2013,) the safety and tolerability profile (number of participants with adverse events)     of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line     treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation. All     treatment schedules that are going to be assessed are considered by the international     guidelines as standard therapy for patients with metastatic Colorectal Cancer.   "
112676|NCT01811095|"     The aim of this study is to determine if training with a robotic simulator improves ability     to perform robotic suturing. We aim to recruit 38 participants (attending surgeons or     residents in obstetrics and gynecology, urology, general surgery, or cardiac surgery).     Participants will be randomized to training with a virtual reality robotic simulator in     addition to clinical work or to usual clinical work alone for a period of 5 weeks. They will     be tested at baseline and post-intervention in the task of suturing a inanimate model with     the actual surgical robot. After the initial study period, the control group will have the     opportunity to cross over and complete the training and then re-testing.   "
112677|NCT01811082|"     The purpose of this study is to compare the lipid lowering effects and clinical safety of a     natural hypolipidemic compound, coenzyme A capsule with a marketed drug, Pantethine Capsule,     in Chinese patients with moderate dyslipidemia.   "
112678|NCT01811069|"     Upper airway obstruction (UAO) during induction of general anesthesia is a frequently     occurring complication. The mechanism of UAO during anesthesia shares many similarities with     the upper airway obstruction observed during obstructive sleep apnea (OSA). Obesity is major     risk factors for OSA and obese patients have a higher prevalence of UAO during anesthesia.     The change of body position improved upper airway stability during sleep in patients with     OSA.We hypothesis that the 30˚ reverse trendelenburg body position maintain airway patency in     obese patients during general anesthesia.   "
112679|NCT01811056|"     This study will test ways to give women more options and flexibility when they are ending     their unwanted pregnancies. The investigators will look at uptake and acceptability of using     mifepristone outside of the clinic for pregnancy termination.   "
112680|NCT01811043|"     The goal of this study is to examine whether a guided meditation intervention will reduce     anxiety and distress as compared to a music intervention or radiologist supportive dialogue     in women undergoing imaging-guided core needle breast biopsies. Both the guided meditation     and music interventions are administered through use of headphones during routine outpatient     imaging-guided core needle breast biopsies. Women in the guided meditation and music     conditions will be given a CD with instructions for home practice. Women complete follow-up     questionnaires in the 12 months after biopsy. Receipt of recommended follow-up care is     examined for 60 months.   "
112681|NCT01811030|"     Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.   "
112682|NCT01811017|"     Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser     for the removal of unwanted tattoos using photographic evaluation and histological findings.   "
112683|NCT01811004|"     The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis     vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary     Hyperhidrosis.   "
112684|NCT01810991|"     The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm     wavelength laser for the treatment of primary hyperhidrosis of the axilla.   "
112685|NCT01810978|"     Infants with congenital heart disease have more frequent infections and exposures to     antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce     the rate of sepsis and necrotizing enterocolitis in infants with CHD   "
112686|NCT01810965|"     Hemochromatosis type 1 is one of the most frequent genetic disease since the genetic     predisposition (homozygosity for the C282Y mutation of the HFE gene) is encountered in about     3/1000 white subjects (5/1000 in Brittany, France).      For the half of these predisposed subjects, the phenotypic expression of the disease needs a     treatment. This treatment is based upon repeated bloodletting which is generally considered     as simple, safe and effective.      Nevertheless, it is still questioned as regard its physiopathological justification and its     clinical implications. Indeed, bloodletting could cause an increase of non-transferrin bound     iron (NTBI) particularly for its reactive form called labile plasma iron (LPI) This adverse     physiopathological effect could have clinical consequences and could be linked with articular     consequences which can be aggravated by the treatment.   "
112687|NCT01810952|"     The investigators hypothesize that includes patient weight and glucocorticoid dose can be     used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be     treated with pharmacological doses of glucocorticoids.   "
112714|NCT01810601|"     To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy     rates versus clinical touch technique   "
112689|NCT01810926|"     • The primary aim of the present trial is to assess in a randomized fashion the benefit on     standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ® in     transplants from matched related donors (MRD) and of anti-CD20 rituximab in transplants from     matched unrelated donors (MUD). Both safety and efficacy of the treatment will be assessed,     in particular in respect to the clinical status of the patient, i.e. prevention of graft     failure and chronic GvHD and of Ebstein Barr virus (EBV) viremia for MUD patients.      The conditioning proposed combines myeloablative drugs with a favorable safety profile such     as treosulfan, thiotepa (Tepadina®) and fludarabine with the intent to reduce the traditional     immediate and late toxicity of busulfan and cyclophosphamide.   "
112690|NCT01810913|"     This randomized phase II/III trial studies how well radiation therapy works when given     together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in     treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor     cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin     and docetaxel, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or transmit tumor killing molecules to     them. It is not yet known whether radiation therapy is more effective when given with     cisplatin, docetaxel, or cetuximab and docetaxel.   "
112691|NCT01810900|"     This multicenter, randomized, single-blind study assessed the safety and efficacy of     Protescal for the reduction of post-operative adhesion formation following myomectomy.   "
112695|NCT01810848|"     Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the     joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an     effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA.     Initiation and maintenance of even low-levels of physical activity is critical for management     of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic     conditioning, lower daily physical activity levels and lower self-efficacy for exercise than     non-OA cohorts.      It has been established that there exists a consistent gradient across activity groups     indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active     individuals. Available research suggests the greatest gains in cardiovascular fitness occur     in moving a sedentary individual to even low levels of physical activity, and 12 weeks is     enough to demonstrate change in the risk profile of at-risk individuals.      Finally, appropriate levels of aerobic and strength training have been shown to be beneficial     in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of     hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity     and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the     change in physical function as well as the cardiovascular risk profile. This is a randomized,     single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham     procedure. Subjects will undergo a regular exercise program for 6 months following     randomization.   "
112696|NCT01810835|"     The prevalence of HBsAg carriage in pregnant women varies in France, according to the native     country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 %     in Parisian area). The level of HBV-DNA varies according to HBe status and geographical     origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It     has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 %     in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns     to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus,     data are needed concerning the current practices about the prevention of HBV MTCT in France,     and their results.   "
112697|NCT01810822|"     Oxidative stress is involved in the pathophysiology of diabetic nephropathy. The     superoxide-generating nicotinamide adenine dinucleotide phosphate-oxidase 2 (NOX2, encoded by     the CYBB gene) and the antioxidant enzyme glutathione peroxidase 4 (GPX4) play opposing roles     in the balance of cellular redox status. In the present study, we investigated associations     of single nucleotide polymorphisms (SNPs) in the regulatory regions of CYBB and GPX4 with     kidney disease in patients with type 1 diabetes.   "
112698|NCT01810809|"     Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation     is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial     joints. The dosis regimen is well established for the knee joint, but there is still no     consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to     determine the optimal dosis for hip viscosupplementation   "
112699|NCT01810796|"     Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin     elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood     pressure or heart rate, prevents postoperative myocardial injury.   "
112700|NCT01810783|"     To determine the safety and efficacy of brexpiprazole during long-term treatment.   "
112701|NCT01810770|"     To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223     dichloride in an Asian population of subjects with CRPC metastatic to the bone.   "
112715|NCT01810588|"     In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord transplant     is a novel and promising way to improve transplant outcomes. We hypothesize that     identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA)     targeted (i.e., cord blood grafts share one or more IPA antigens with the prospective     recipient) is more important to the outcome of haplo cord transplant than the nucleated cell     dose. The identification of such a graft for a large proportion of the subjects may     necessitate accepting a lower umbilical cord graft dose.      In addition to a umbilical cord blood transplant, recipients will receive stem cells from a     family member ( a haplo-identical donor) . After collection and prior to infusion, these     cells will be purified using a device called a CliniMACS CD34 selection device. The subject     will undergo a chemotherapy conditioning regimen prior to transplantation. No experimental     drugs are used in this study, and the combinations of drugs that will be used in the     conditioning regimen are combinations that have been used in the past.   "
112702|NCT01810757|"     Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause     significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are     unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but     would have a normal life expectancy if their cancer were adequately controlled. Retrospective     studies suggest that radiotherapy which is given weekly using fewer fractions and higher     doses (hypofractionated), may be an alternative where daily radiotherapy is not an option.      Radiotherapy treatment is planned based on information from a CT scan which shows the     position and shape of the bladder. This plan needs to take into account the fact that the     bladder's shape and position can change, depending on how full it is and because of where it     is in relation to the bowel. A safety margin is therefore added around the bladder on the     planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy.      It is now possible to take scans of the bladder's position before each treatment and adjust     the position of the treatment plan accordingly to ensure the bladder is fully covered by it.     In this study we are also looking at whether it is possible to design a series of treatment     plans with different size safety margins and then choose one that fits best for each     particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate     treatment delivery using smaller safety margins and this might help to reduce side effects.      Aims      In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:        1. whether treatment using adaptive planning can be successfully delivered at multiple          sites across the UK and results in acceptable levels of toxicity        2. the local tumour control rate achieved by hypofractionated weekly radiotherapy        3. the requirement to treat with adaptive planning.      How results will be used Results will provide robust evidence for use of hypofractionated     radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient     population. The randomised element of the trial will support the implementation of     image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence     on the benefits or otherwise of this methodology and inform the development of further trials     in this and other patient groups.   "
112703|NCT01810744|"     The treatment of the most common cancers (colon, breast, lung, liver and kidney) has recently     added a new therapeutic class known as the anti-angiogenic. It was born from a better     understanding of tumor growth requires the development of neo-vessels. These new vessels are     of major importance for the viability of the tumor but also the birth of metastases. This     neo-angiogenesis is complex and results from an imbalance between pro-angiogenic factors and     anti-angiogenic factors. Growth factor VEGF and its receptors (VEGFR-1, VEGFR-2 and VEGFR-3)     are a way of survival of endothelial cells required for tumor neoangiogenesis. The     anti-angiogenic drugs currently available on the market are bevacizumab (Avastin ®),     sunitinib (Sutent ®) and sorafenib (Nexavar ®). The mechanism of anti-angiogenic action of     these three main drugs are pharmacological inhibition of the VEGF pathway.      These new anti-angiogenic therapies, however, have significant adverse effects are common and     some other more serious but rare.      Hypertension is the most common side effect observed in patients treated with anti-VEGF. This     is usually iatrogenic hypertension controlled by antihypertensive therapy and rarely     compromises the pursuit of anti-angiogenic therapy. More rarely, it can have serious     consequences malignant hypertension, severe hypertension refractory reversible posterior     leukoencephalopathy associated with severe hypertension have also been reported.      The pathophysiology of hypertension may be due to the neutralization of major physiological     effects of VEGF in endothelial cell and therefore the vascular wall.      The study of the microcirculation is not only useful in the diagnosis of microvascular but     also macrovascular disease in the evaluation of chronic arterial and venous severe it     determines the prognosis. In these indications, capillaroscopy remains the gold standard for     all work pathophysiological because visualization of phenomena measured avoids artifacts and     difficulties of interpretation. It then appealed to additional technology to directly measure     the capillary pressure, capillary flow velocity, and indirectly assess capillary permeability     and function of lymphatic canaliculi. The simplest of these technological inputs: video     microscopy and digital image analysis, have also improved the practice of routine clinical     capillaroscopy in its main field of application, evaluation of microangiopathy connective.     The examination can be performed more quickly and easily archived and quantified.      Only two studies on 14 and 16 patients were able to see a decrease in capillary density     correlated with the therapeutic activity of anti-angiogenic the tumor mass and metastasis.      Thus, we propose to quantify in a number of relatively large patient patients the decrease in     capillary density as well as the relationship between the decrease in the number of     capillaries and anti-tumor response.      The study will also aim to measure the prevalence of hypertension in patients treated with     bevacizumab and to establish the link between these data and the modification of the     capillary microcirculation.   "
112704|NCT01810731|"     In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are     the most important risk group for season influenza vaccination based upon compelling     evidence of substantial risk of severe disease in this group and evidence that seasonal     influenza vaccine is safe and effective in preventing disease in pregnant women as well as     their young infants, in whom disease burden is also high. Recent data from Kenya, similarly     suggest rates of influenza-associated hospitalizations in children under age 1 to be as high,     or higher, than those observed in the United States. However, TIV may have reduced     immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental     transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a     double-blind randomized controlled trial of influenza vaccines stratified by HIV status in up     to 720 pregnant women in their second and third trimesters and their infants residing in     health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We     propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double     dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal     influenza vaccination policies in Kenya and other African countries.   "
112722|NCT01810497|"     The aim of the study is to investigate the possible influence of different durations of use     of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty.     We hypothesize that the duration of elastic bandage use has no significant influence on the     incidence of relapse of prominence of the ears and need for reoperation.   "
112705|NCT01810718|"     Chronic Graft versus Host Disease (cGvHD) has been identified as the leading cause of late     non-relapse mortality in Hemopoietic Stem Cell Transplant (HSCT) survivors. Up to now a     standard satisfactory treatment for these patients does not exist. cGVHD is an     immune-mediated disease, resulting from a complex interaction between donor and recipient     adaptive immunity, but its exact pathogenesis is still incompletely defined.      The purpose of this study is to determine safety and efficacy of Nilotinib in a population     with steroid-refractory/or steroid-dependent cGvHD with a phase I study.      In phase II the MTD will be used to define the efficacy of Nilotinib in a cGvHD steroid-     refractory or steroid dependent population, with the same characteristics of the previously     Imatinib-treated population.   "
112706|NCT01810705|"     The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells,     eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65     years diagnosed with AML and unfit for intensive chemotherapy.   "
112707|NCT01810692|"     In COPD the patient's ability to use inhalers correctly and their preference for the inhaler     are both important factors in selecting an appropriate treatment for COPD. This is a     cross-sectional study where satisfaction, preference and handling of two different devices     such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD     patients   "
112708|NCT01810679|"     To demonstrate the safety and effectiveness of the Perceval S heart valve when used to     replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.   "
112709|NCT01810666|"     Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand     treatment for children with severe Hemophilia A.   "
112710|NCT01810653|"     The study design combines a long-term safety and a dose range determination objective. The     first 8 weeks of the study were primarily intended for the dose range determination, while     the later visits were used for the comparison of long-term safety between the groups.   "
112711|NCT01810640|"     This study's objective is to obtain preliminary data to test the hypotheses that percutaneous     liver biopsy in brain death donors is safe and provides reliable histological information.     Furthermore, that information when disseminated fully and widely many hours before organ     recovery would not only decrease economic costs of wasteful recovery of livers that are not     ultimately transplanted but also increase transplantation and decrease cold ischemia times of     recovered livers.   "
112712|NCT01810627|"     This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure     in patients treated with interstitial permanent seed implants for low and intermediate risk     prostate cancer. All patients will received the same standard of care treatment but will     receive an additinoal CT image of the prostate.   "
112713|NCT01810614|"     Recent evidence has shown that kidney volume predicts the likelihood of developing renal     insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth     of cysts and the harm they do to kidney function. Recent studies indicate that the rate of     kidney volume increase is hastened by excess dietary protein, salt, and potential net acid     precursors, and slowed by increased water intake sufficient to lower plasma vasopressin     levels.      Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the     end-stage, but there is currently no specific diet prescription that takes potentially     harmful dietary elements into account for ADPKD patients in the earliest stages of the     disease. This study will examine a novel diet for ADPKD created by the researcher termed the     ADPKD diet.   "
112717|NCT01810562|"     The purpose of this study is to determine whether tactile stimulation for reduced sensibility     of the affected extremities after stroke has effect.      Hypothesis:      Stimulation of sensibility after stroke will have a significant contribution for improved     sensibility. Without any stimulation, no signal is sent to the brain and there is no need for     the healthy parts of the brain to adapt this function. Stimulation of the sensibility over a     period of time on both sides of the body, gives the brain signals and the opportunity to     compare how the signals should be recognized. New connection will be able to interpret     signals correctly.   "
112718|NCT01810549|"     The aim of the study is to investigate, if postprandial fatigue symptoms after ingestion of a     high-fat, high-carbohydrate meal are regulated by Interleukin (IL)-1 and can be prevented by     inhibition of IL-1 using a single dose injection of a specific IL-1 receptor antagonist.   "
112719|NCT01810536|"     Respiratory exacerbations are frequent among cystic fibrosis patients and supplemental oxygen     is usually required. We will compare a new high flow nasal cannula system with Venturi masks     for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation.   "
112720|NCT01810523|"     Study will test the use of narratives on patient satisfaction and translation of an     evidence-based approach to the use of X-rays for leg injuries in the Emergency Department     (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom     X-rays are determined to not be needed. On discharge, patients will receive the current     fact-based sheet or that plus a narrative explaining the work-up and treatment of these     injuries. Outcomes will be assessed by a survey measuring patient satisfaction and     understanding.   "
112723|NCT01810484|"     Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study     treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or     CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment.     Study images will be obtained pre-treatment, approximately 30 minutes post-treatment, and at     each follow-up visit.   "
112724|NCT01810471|"     Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim     of our study is to quantify the stabilizing effect of different devices. Through the use of a     foot measurement model in 3D motion analysis the influence of the devices with respect to a     mechanical effect is examined by means of different tests. The dynamic postural control is     quantified. The hypothesis was that the devices would stabilize differently the foot     segments.   "
112725|NCT01810458|"     We hypothesize that individuals with Alpha-1 Antitrypsin (AAT) deficiency have ongoing liver     injury which is not detected by the usual blood tests used to look at liver function. This     ongoing liver injury leads to cirrhosis in a significant number of adults with AAT     deficiency.   "
112726|NCT01810445|"     The purpose of this pilot study is to develop the methodology for an innovative subsurface     imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow     the non-invasive analysis and imaging of tissues and chemical distributions in the body at an     imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.   "
112727|NCT01810432|"     The purpose of this study is to measure how much of the drug gets into the blood stream and     how long it takes the body to get rid of it when given to healthy participants. Information     about any side effects that may occur will also be collected.      The study has 2 periods. In each period, participants will take the study drug for 10 days,     either with or without a meal. There is a minimum 14 day washout between each period.      This study is approximately 50 days, not including screening. Screening is required within 28     days prior to the start of the study.   "
112728|NCT01810419|"     In internal medicine, assessment of spleen size on physical examination is an extremely     important part of the overall evaluation of patients with many illnesses. Examination of the     spleen is also one of the core competencies that the investigators expect our students and     residents to learn as part of their training. Unfortunately, the sensitivity and specificity     of examination of the spleen at the bedside is not very good. The investigators wish to     determine if handheld ultrasound can accurately assess spleen size. Doing so would make     physical examination of the spleen obsolete and transform training objectives for medical     students and residents.   "
112729|NCT01810406|"     Combined spinal-epidurals (CSE) involve the injection of pain relief medication into the     cerebral spinal fluid (CSF) and the insertion of an epidural catheter in the epidural space     to continue to give pain relief medication. During a CSE, after injection of the medication     in the CSF and before inserting the epidural catheter, if normal saline is injected into the     epidural space, there may be an increase in pain relief and an increase in the level of     numbness. This injection of saline in the epidural space to increase pain relief and numbness     is termed epidural volume extension (EVE). The purpose of this study is to determine if there     is a benefit for EVE to improve labor analgesia (pain relief) using CSE in pregnant laboring     patients.   "
112730|NCT01810393|"     This open-label, randomized, multicenter study will evaluate participant preference for     subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with     HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab     for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle     length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of     trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive     trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until     disease progression or inacceptable toxicity occurs, whichever comes first.   "
112731|NCT01810380|"     To determine the efficacy and safety of brexpiprazole for the treatment of adults     experiencing an acute episode of schizophrenia.   "
112732|NCT01810367|"     Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With     Cisplatin in first Treatment of NSCLC   "
112750|NCT01810133|"     Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status     (American Society of Anesthesiology) is the most commonly scale to assess this parameter and     has yet been repeatedly criticized in the past for its discriminatory power.      Few studies have shown both the ASA physical status and the more detailed and more     time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.      The purpose of this observational study is to compare the predictive value of both scales     with regards to all-cause in-hospital mortality and hospital length of stay.   "
112733|NCT01810354|"     Surgical site infections are common and a cause of major morbidity. They are also more common     in obese women. Cesarean sections are the most common surgery performed in the United States,     therefore pregnant women are being faced with this problem frequently. There is evidence to     show that prophylactically administered antibiotics, cefazolin specifically, to obese women     prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent     infection. The purpose of this study is to evaluate if an increased dose of cefazolin will     attain adequate tissue concentration in obese women. Our hypothesis is that three grams of     cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese     (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue     concentration compared to two grams of cefazolin.      Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton     pregnancy and require a cesarean section for any obstetrical indication. Women will be     excluded if they have a suspected infection, have a multiple gestation, or have preexisting     diabetes or hypertension with end organ damage. The subjects will be screened both by through     the OR schedule as well as through the clinics. They will then be consented and enrolled by     the primary investigator. Once enrolled the subjects will be randomized to receive either two     grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60     minutes prior to the start of the surgery.      Two adipose tissue samples will be obtained at the time of surgery. The first at the start     after skin incision and the second at the end prior to closure of the skin. There will also     be a separate IV placed at the start of the procedure from which three blood draws can be     collected. These three samples will be obtained at the start of the surgery but after     antibiotic administration, at the time of the first adipose collection, and at the time of     the second adipose collection. The samples will then be stored at -80 degrees and shipped to     David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis.      While the subjects are in the hospital recovering from their surgery, a chart review will be     performed to determine if there are any infections occuring post-operatively. A telephone     survey will be conducted six to eight weeks postpartum again assessing for any infectious     complications after the cesarean section.   "
112756|NCT01810042|"     Exudative age-related macular degeneration (ARMD) is complicated by choroidal     neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the     gold standard treatment, recurrence is the main limitation of the treatment. The changes of     the CNV vascular structure is expected to provide information regarding recurrence. In the     eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the     vascular changes after ranibizumab injections will be investigated prospectively.   "
112793|NCT01809561|"     The purpose of the study is to assess the telomere array of different endometriosis tissue     and endometrium from women with endometriosis compared to healthy women.      Our hypothesis is that telomere shortening and high telomerase activity will be found in     tissues from women with endometriosis.   "
112734|NCT01810341|"     This study will prospectively enroll approximately 880 children, at least 18 months and less     than 60 months of age, who have been referred to a pediatric developmental evaluation center.     Enrolled children will have blood drawn for RNA gene expression analysis and optionally for     metabolite, lipid and DNA analysis and undergo a clinical evaluation to determine the     presence or absence of a diagnosis of ASD.      The primary objective of this study is:      - To develop an algorithm to classify blood RNA gene expression patterns to maximize     agreement between the classification and a clinical assessment of presence or absence of     Autism Spectrum Disorders (ASD).      The secondary objectives of this study are:        -  To develop an algorithm to classify plasma metabolite and/or lipid profiles in such a          way as to maximize agreement between the classification and a clinical assessment of          presence or absence of ASD.        -  To prospectively assess the clinical sensitivity and specificity of the plasma          metabolite and/or lipid profile classification algorithm in a separate population          consisting of children referred to a developmental evaluation clinic for a possible          developmental disorder (DD).        -  To evaluate clinical sensitivity and specificity of various combinations of gene          expression signature, metabolite and/or lipid signatures, and presence of ASD-associated          genetic variation detected by chromosomal microarray analysis (CMA) or sequencing          protein-coding regions of the genome.   "
112735|NCT01810328|"     The purpose of this study is to learn more about how to treat patients with severe injuries     related to trauma and to prevent failure of vital organs in this patient population.     Approximately 200 severely injured patients with blunt trauma and 40 healthy volunteer     subjects will be enrolled in this study. During the study seven blood samples (4-5 mls) will     be collected from patients who have suffered severe trauma over a 28 day period. A one time 5     ml blood sample will be collected from the healthy volunteers. Clinical data will be     collected daily while patients are hospitalized. The initial blood sample must be collected     from qualifying patients within the first 12 hours of admission to the hospital. The reason     for blood sampling is to validate a rapid genomic test in real time. Once confirmed, this     genomic test can be used to identify patients who will have a complicated clinical course and     would, therefore, be good candidates for interventional, immunomodulatory therapies.   "
112736|NCT01810315|"     Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety     parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator     use in premenopausal and postmenopausal women.   "
112737|NCT01810302|"     The purpose of this study is to determine if intrathecal nicardipine is safe for the     treatment of cerebral vasospasm.   "
112738|NCT01810289|"     START is clinic-level (not individual-patient) intervention to catalyze the process of ART     initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g.,     adults with a CD4 T cell level < 350/ul). The three START components are: (1) real-time     point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in     real time at first presentation to care, (2) targeted knowledge transfer (i.e.,     dissemination) of recent scientific evidence regarding effects rapid ART initiation on     survival to front line health care workers; and 3) feedback and reporting to clinic and     providers. There three components represent empirically validated steps in the PRECEED     implementation model.   "
112751|NCT01810120|"     Allocation: Non-Randomized Endpoint Classification: Safety/Feasibility Intervention Model:     Single Group Assignment Masking: Open Label Primary Purpose: Treatment Study to assess the     feasibility and safety of the infusion of a T cells receptor (TCR) alfa beta depleted graft     in pediatric patients affected by malignant and non-malignant hematological disorders and     receiving an Hematopoietic stem cell transplantation (HSCT) from a Human leukocyte antigen     (HLA) partially matched family donor.   "
112752|NCT01810107|"     The specific aim of this study is to develop a growth and development chart (similar to a     height or weight chart for children) that identifies the pattern of development of the     pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim     is to identify whether this growth chart shows a pattern of linear development or whether     there are clear critical periods of development.   "
124490|NCT01656239|"     The purpose of this study is to determine the dose level(s) of fedovapagon which result in a     decrease in the mean nocturnal void frequency.   "
112739|NCT01810276|"     The objective of this study is to determine if the administration of platelets will improve     outcome in patients with ICH who are being treated with either aspirin, a thienopyridine     (ticlodipine, clopidogrel, prasugrel) or a combination of both. The study has four specific     aims:        1. To determine what affect platelet administration will have on bleeding in the brain.        2. To determine what affect platelet administration will have on brain function. Several          assessments to test the functioning of the brain will be performed at enrollment and          throughout the study. Comparing the results of these assessments between the          experimental and control groups should allow us to determine if platelet administration          improves outcomes in patients with bleeding in the brain exposed to antiplatelet          therapy.        3. An important risk of reversing antiplatelet therapy is exposing the patient to the very          complications this therapy was designed to prevent. Therefore, tracking complications          will be a very important part of this study. The investigators will compare the rates of          death, heart attack, stroke and clots in the veins between groups.        4. Some patients (10-40%) have limited responsiveness to antiplatelet therapy. While          platelet responsiveness, as measured by a special platelet blood test, will not affect          enrollment, the investigators feel it will be important to measure.   "
112740|NCT01810263|"     The aim of this prospective randomized controlled study is to demonstrate the efficacy of     Intensive Nutritional Supplement in Patient with Stroke.   "
112741|NCT01810250|"     The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates     the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this     study is to collect clinical information on the performance of the Endurant Stent Graft     System for endovascular repair in anatomically challenging aneurysms, and to critically     assess whether the current guidelines for anatomic eligibility to endovascular treatment with     this system are still applicable. This study aims at creating a database that can be pooled/     compared with the ENGAGE database.      This study aims at answering two major questions:        1. Is the technical success rate of successful delivery and deployment of the Endurant (II)          similar in anatomically challenging aneurysm?        2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or          does treatment of these aneurysms lead to more complications and reinterventions?   "
112742|NCT01810237|"     Research Questions:        1. Does using dabigatran bridging result in consistent therapeutic anticoagulation? What          percentage of patients will become subtherapeutic on warfarin once dabigatran is          stopped?        2. What is the incidence of bleeding events with the use of dabigatran overlapped with          warfarin for bridging?        3. What is the cost benefit of using dabigatran instead of dalteparin for bridging          anticoagulation?   "
112743|NCT01810224|"     This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim     of this study is to assess the importance of functional assessment of coronary artery disease     prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the     traditional Angio-guided strategy in the guidance of surgical revascularization by     aorto-coronary bypass grafting.   "
112744|NCT01810211|"     This study will look at which, if any, active stretching procedure is most effective at     correcting posterior shoulder tightness (PST) in the post-operative population. Posterior     shoulder tightness can influence shoulder mobility and function within both a symptomatic and     an asymptomatic population. There are previous studies that have examined the effectiveness     of different active stretching procedures and their ability to correct PST but only in the     asymptomatic population. As clinicians it will be helpful to investigate their effect within     a symptomatic population in order to prescribe appropriate and effective stretches within an     individual's home exercise program. The study design is a double blinded randomized control     trial. During evaluation a passive measurement of PST and internal rotation will be     performed. Another therapist, blinded to the measurements, will randomly select which     subgroup the individual will be placed in for the first three individuals and this sequence     will be followed for the remainder of the participants. At this time the therapist will     instruct the individual on the corresponding exercise which they will perform in front of     that therapist. The individual will perform this exercise one more time that day and twice     the following day and once again upon follow up prior to having internal rotation and PST     measured once again. At this point this will be the conclusion of that individuals     involvement in the study.      Null Hypothesis1: Stretches are no more effective than no treatment for reducing PST acutely     in the post-operative shoulder population.      Hypothesis1: Stretches are more effective than no treatment for reducing PST acutely in the     post-operative population.      Null Hypothesis2: There is no significant difference in the reduction of PST between the     horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative     shoulder population.      Hypothesis2: There is a significant difference in the reduction of PST between the horizontal     adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder     population.   "
112745|NCT01810198|"     To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided     selective catheterization strategy for stable patients but without known CAD and an American     Heart Association/ American College of Cardiology Class II indication for non-emergent     invasive coronary angiography.   "
112746|NCT01810185|"     The investigators will be looking at the efficacy of the use of once daily use of low dose     naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.   "
112747|NCT01810172|"     Often the decision for chest tube removal or trial of chest tube clamping is based on     subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and     recording of air leaks has been done using digital pleural drainage devices. This provides us     with objective and continuous recording of air leaks as well as changes in pleural pressure.     Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in     shorter hospital stay in comparison to traditional pleural drainage systems.   "
112748|NCT01810159|"     Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments     for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs     and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS,     integrated collaborative care (ICC) and education and resources (E&R). The investigators     hypothesize that ICC will be more effective than E&R in promoting A. Implementation outcomes     B. Service system outcomes and C. Patient outcomes.      Results from our study will help providers choose between two different strategies and     advance the field of implementation research.   "
112749|NCT01810146|"     60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients     with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type     2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients     and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal     pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose     oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio     urinary excretion. Intestinal and colonic biopsies will be also provided for studying     permeability. For only patients, samples from the gastric resection will be provided for     analysing the enteric nervous system and motricity.   "
112753|NCT01810094|"     Spinal injuries, such as vertebral fractures, often result in a significant instability of     the spine and lead to acute or delayed neurological deficits. Depending on the type of injury     there are various methods available to stabilize the spine. The proposed study should clarify     whether the combined reduction and fixation with a minimally invasive approach can actually     be done with the same precision as in a conventional approach. The primary endpoint of this     investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the     first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical     and subjective patient outcome parameters for its patient population that will allow to     compare the results to a historical group of patients. The study design is     non-interventional, prospective, open,and multicentric.   "
112754|NCT01810081|"     In this study, the presence of H.Pylori in the gallbladder mucosa of patients with     symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori     infection of the gastric mucosa was also investigated to study the relationship of gastric     H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric     mucosa may have a role in the formation of gallstones.   "
112755|NCT01810068|"     The impact of of different surgical treatment modalities of benign prostatic hyperplasia in     men on their sexual function is not well studied.      The investigators will investigate prospectively the effect of conventional monopolar     transurethral resection of the prostate (TURP), bipolar TURP and Holmium laser enucleation on     urinary and sexual functions.   "
118273|NCT01737853|"     The objective of this phase IV clinical multi-center trial will be to compare the efficacy     and safety of Ganforti® versus Krytantek®, using a cross-over design during a six month     period (including a one-month wash-in period) in POAG and OH patients.   "
112757|NCT01810029|"     The overall hypothesis of this study is that a cardiac rehabilitation program with meditation     will be more effective than cardiac rehabilitation alone in improving blood flow through the     diseased coronary arteries in African Americans. For this purpose, 56 African American men     and women with coronary heart disease will be randomly assigned either to standard cardiac     rehabilitation plus the Transcendental Meditation program or to standard cardiac     rehabilitation alone. The treatment period will be 12 weeks in length.   "
112758|NCT01810016|"     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of     Ipilimumab i.v. followed by NY-ESO-1 Protein vaccine with Poly-ICLC and Montanide s.c. (Arm     A), or NY-ESO-1 OLP4 vaccine with Poly-ICLC and Montanide s.c. (Arm B), or NY-ESO-1 OLP4     vaccine mixed with Poly-ICLC without Montanide s.c.(Arm C).   "
112760|NCT01809990|"     The main goal of this trial is to study the feasibility and effectiveness of     internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive     disorder.   "
112761|NCT01809977|"     The purpose of this study is to determine which surgical method makes less corneal haze   "
112762|NCT01809964|"     The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral     Canthal Lines.   "
112763|NCT01809951|"     The use of soy-isolate protein based formula for infants with cow's milk protein intolerance     is common in Indonesia, however, there has not been any systematic collection of clinical     data to determine the formula's gastrointestinal tolerance, and the parent's perceptions     regarding the formula.   "
112764|NCT01809938|"     Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee,     the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this study     is to demonstrate whether there is really a delay in gastric emptying time associated with     the inclusion of milk in a cup of tea.   "
112765|NCT01809925|"     This is a randomized, double-blind, placebo-controlled, 2-treatment, 3-period crossover     design study to evaluate the effects of psyllium 6.8 g provided as sugarfree Metamucil fiber     supplement powder dissolved in water versus placebo on satiety measures in healthy     volunteers. This study will be conducted at a single study site.   "
112766|NCT01809912|"     To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in     patients with solid tumors for which no standard therapy is available.   "
112767|NCT01809899|"     The overall goal of the proposed study is to insure the protection and safety of human     subjects who have been previously exposed to interpersonal traumatic events and who are     participants in symptom provocation research. The investigators intend to examine trauma     history, cognitive, interpersonal, and genetic predictors of participants' unfavorable     reaction to participation in research involving trauma-related script-driven imagery (SDI).     The design includes comparing participants in a consent as usual group to participants in an     enhanced consent group to see which minimizes unfavorable effects of participating in a     research provocation study. In addition, the two different consent groups will be assessed     for their effects on psychobiological and neurobiological stress response. Furthermore, the     investigators will examine the relationship between the psychobiological responses and neural     mechanism during SDI, and unfavorable reactions to participation in symptom provocation     research.   "
112768|NCT01809886|"     The purpose of this clinical trial is to prove that the administration of sugammadex at a     dose of 4 mg/kg for counteracting deep blockage [without train-of-four (TOF) ratio response     and post-tetanic count (PTC) < of 2 induced and maintained with Rocuronium in pediatric     patients for short-term elective surgery.   "
112769|NCT01809873|"     This project aims to test an innovative, sustainable financial incentive designed to reduce     the number of non-malarial fevers that are treated inappropriately with antimalarial drugs.   "
112770|NCT01809860|"     The purpose of the study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics (PK) of sirolimus after single dose administration.   "
112771|NCT01809847|"     To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of     allogeneic HCT in CLL   "
112772|NCT01809834|"     Evaluation of two contact lenses   "
112808|NCT01809353|"     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the     drug) and safety of JNJ-54452840 in healthy participants.   "
112809|NCT01809340|"     The purpose of this study is to assess whether the antidepressant effect from intravenous     (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV     ketamine treatment is stopped.   "
112773|NCT01809821|"     Sleep is an essential component of good physical and mental health. Previous studies have     reported that poor quality sleep is associated with an increased risk of hypertension, stroke     and cardiovascular disease (CVD). Hypertension is the most common and important risk factor     for CVD, and even modest reductions in blood pressure result in significant reductions in     stroke and myocardial infarction. In this randomised trial, the investigators aim to evaluate     whether a simple, multi-component, online sleep intervention reduces blood pressure in     patients with essential hypertension.   "
112789|NCT01809613|"     This study is investigating the usefulness of using functional magnetic resonance imaging     (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease,     Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The     study may determine the relationship between patterns of brain activation and therapeutic     outcome and/or side effects.   "
112774|NCT01809808|"     The purpose of this study is to evaluate hormone values and other markers of disease activity     in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after     surgical or other treatment. This study is designed to determine blood levels of growth     hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of     the disease at diagnosis and how these parameters change over time after surgical or other     therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects     who will each be studied just once with an oral glucose tolerance test (OGTT). These data     will provide a comparison group to the acromegaly subjects.   "
112775|NCT01809795|"     The purpose of this study to determine if adding blueberries to obese children's diet will     improve weight status and other medical testing. We would also like to determine if a larger     research study involving blueberries is possible.   "
112776|NCT01809782|"     Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing     two-time liver resection.   "
112777|NCT01809769|"     Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for     each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following     initial injection.   "
112778|NCT01809756|"     Rationale: In the Netherlands 1731 people are being diagnosed with SCLC (Small Cell Lung     Cancer) in 2010. This is approximately 14% of all new diagnosed lungcancers. Part of them     will need a combination of chemo-radiationtherapy. A review of the incidence and severity of     esophagitis in SCLC patients receiving a combination of chemotherapy and once daily     radiotherapy revealed overall esophagitis rates up to 58% experiencing esophagitis grade 2     and higher. As concurrent radiotherapy is moving to twice daily radiation (30 x 1,5 Gy in 3     weeks) it is expected that the incidence of esophagitis will rise, the clinical symptoms are     likely to arise earlier and become more severe.      Mucositis of the upper tractus digestivus is a serious adverse event leading to pain,     problems with swallowing and decreased food intake. It has a negative infect on QoL and can     lead to prolonged hospital stay and delayed cancer treatment. Physicians seek improvements in     treatment modalities to improve these daily patient toxicities.      Caphosol® is an advanced electrolyte solution indicated as an adjunct to standard oral care     in treating oral mucositis caused by radiation or high dose chemotherapy. Positive effects of     Caphosol® oral rinse 4 times daily in a study with head and neck chemoradiation patients were     found on the presence of mucositis and on oral comfort.      It's supposed that the pathogenesis of chemo- or radiotherapy induced mucositis is the same     for the whole tractus digestivus. The appearance does differ due to differences in cell     proliferation.      Swallowing Caphosol® after oral rinse could have a positive effect on esophageal mucositis on     time of onset, severity and duration.      Objective: Adding the use of Caphosol® (rinsing and swallowing four times a day) to the     standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and     severity of esophagitis in SCLC patients, comparing to the standard of care alone.      Study design: A multi-centre, open, randomized prospective phase II study. Study population:     108 patients 18 years or older with histologically proven SCLC (all histological subtypes),     treated with concurrent chemo- and radiotherapy are estimated to be included in this study     (2:1 ratio inclusion; 72 patients with Caphosol® and 36 patients without Caphosol®; α=0.05,     power 80%).      Intervention (if applicable): 108 patients eligible for this study will be monitored during     their SCLC chemo/radiotherapy treatment. One group of 72 patients will receive Caphosol®, 4     times a day - next to the standard of care. Caphosol® will start at day 1 of treatment and     will be continued until 3 weeks after the last radiotherapy (RT).Another group of 36 patients     will receive only the current standard of care for esophagitis. The patients will be randomly     assigned to one of the groups.      Main study parameters/endpoints: The primary objective is to estimate the incidence, onset,     duration and severity of esophagitis in SCLC patients undergoing radiation therapy with     chemotherapy who receive Caphosol®.      Secondary study parameters/outcome of the study (if applicable):        1. To correlate components of esophagitis data with clinical outcomes (pain, dysphagia,          analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL)        2. Discontinuation or delay of chemotherapy due to esophagitis. Nature and extent of the          burden and risks associated with participation, benefit and group relatedness: The risks          are very small. The patient has to fill in a Esophagitis Daily Questionnaire and during          regular visits QOL questionaires are performed.      Sputumswabs are collected on a weekly basis for determination of the microbiological flora of     the mouth. During regular blood control max. 8 ml extra blood is taken for immunologic status     research.      Caphosol® is a saturated calciumphosphate solution. The daily intake of calcium and phosphor     when swallowing Caphosol® 4 times daily is far beyond the Acceptable Daily Intake (ADI)(<     5%). Compared to daily nutrients like milk (270 mg calcium per unit milk (225 ml)) or meat     (200 mg phosphor per 100 g meat) the intake of calcium and phosphor due to Caphosol® is     negligible and is considered safe.   "
112779|NCT01809743|"     The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady     state hyperemia as compared to central venous infusion of adenosine for assessing fractional     flow reserve. (adenosine is considered to be the gold standard)and to investigate the time     intervals of maximum hyperemia induced by centrally and peripherally administered     Regadenoson.   "
112780|NCT01809730|"     This is a non-randomized, non-interventional pilot observational study designed to follow     high-risk patients through their surgical and hospital stay. The investigators will collect 2     4ml vial's of blood (total of 8ml) prior to surgery to assess CV biomarkers - inflammatory,     metabolic, hypercoagulable and platelet.   "
112781|NCT01809717|"     This study will establich the feasibility of weight lifting exercise among patients with     multiple myeloma, determine if weight lifting exercise increases lean body mass among     patients with multiple myeloma and obtain further preliminary data on toxicity and     pharmacokinetics of high-dose melphalan.   "
112782|NCT01809704|"     To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the     commercially available Cirrus   "
112783|NCT01809691|"     The purpose of this study is to compare overall survival in newly diagnosed metastatic     prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700     versus ADT + bicalutamide.   "
112784|NCT01809678|"     This study examines the efficacy of yoga as a complementary therapy for smoking cessation   "
112785|NCT01809665|"     This investigation is designed to provide supporting evidence for the clinical safety of the     Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T     (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic     resonance imaging) conditions.   "
112786|NCT01809652|"     The purpose of this study is to gain real world, live implant experience with the remote     implant support system. This system is intended to provide the technical support for device     implants from a remote location through telepresence (audio and video) and remote control.     Specifically, the goals of this study are to corroborate bench testing, assess the     performance of the system, gain understanding of the workflows, customer experience, and     logistics.      The intent of the remote support model is to provide the same support that would typically be     provided by a local support person, only remotely. As such, the remote support person would     only perform actions that a local support person would routinely do under the direction of a     physician. This may involve observing patient data, providing technical support and advice,     and performing testing and device reprogramming via remote control of the programmer.   "
112787|NCT01809639|"     Concussions are a common injury among athletes in the United States. The annual incidence of     sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8     million, and the likelihood of an athlete in a contact sport experiencing a concussion is as     high as 20 percent per season. Even mild traumatic brain injury, including concussion, can     cause long-term cognitive problems that affect a person's ability to perform daily activities     and to return to school or work. Far more concerning is the mounting body of evidence that     concussions are not just transient injuries - but have cumulative effects. It has been well     established in animal models that progesterone has neuroprotective benefits. Animal studies     using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema,     reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral     outcomes. To date, there have been no studies to assess whether or not progesterone will be     effective for the treatment of concussions. This double-blind placebo controlled trial will     assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the     duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize     that athletes treated with progesterone will have faster resolution of their concussive     symptoms. The investigators believe this study may be the first clinical trial to show an     effective treatment for concussion.   "
112810|NCT01809327|"     The purpose of this study is to assess the effectiveness of the co-administration of     canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and     metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite     treatment with diet and exercise. The safety and tolerability of canagliflozin will also be     assessed.   "
112788|NCT01809626|"     The primary goal of this single-blind, placebo-controlled, within-subjects, double-scan,     one-visit neuroimaging study is to examine the effects of the hypnotic zolpidem (Ambien®) in     individuals who are maintained on selective serotonin reuptake inhibitors (SSRIs) for the     treatment of major depressive disorder. Specifically, levels of the brain chemical GABA will     be examined in the anterior cingulate and thalamus, two brain regions that play important     roles in mediating some of the effects of depression and sleep-related drugs, respectively.     Depressed individuals typically have lower levels of GABA than the healthy population, and     antidepressant treatment has been shown to help normalize this neurochemical in conjunction     with improved mood. Given that individuals maintained on SSRIs often are prescribed     sedative/hypnotics to treat concurrent insomnia, understanding a possible neurochemical     interaction between them, whether beneficial or harmful, is important for informing     evidence-based treatment strategies to treat the co-morbid patient. Zolpidem's effects on     GABA in participants who are maintained on SSRIs will be compared to baseline GABA levels in     these individuals (i.e., following placebo administration). Two separate scanning sessions     lasting approximately 45-60 min each will take place within one single study visit in order     to obtain these measurements using proton magnetic resonance spectroscopy (1H MRS). This type     of neuroimaging is like an MRI in that it is non-invasive, but it permits us to obtain     information about chemicals in the brain. A secondary goal of this study is to compare the     subjective drug effects, or how individuals feel, following the intervention. These measures     will be used to determine the existence of brain-behavior relationships in order to assess     the extent to which modulating GABA with zolpidem has effects on mood states in depressed     participants. Collectively, this study will contribute to our understanding of how these     drugs exert their effects when one is administered in the presence of the other, and it will     demonstrate that imaging is an important tool for informing us about how drug effects in the     brain ultimately result in behavior.   "
112794|NCT01809548|"     Introduction: Preterm infants with a birth weight less than 1500 grams have special     nutritional needs in comparison to full-term neonates. During their stay in the neonatal     intensive care unit an increased supply with energy, protein and electrolytes is necessary to     establish adequate growth. After discharge from the hospital special breast milk supplements     or post discharge formulas are available to cover the special nutrient requirements.     Complementary feeding in preterm infants is an unexplored field so far and nutritional     concepts for the first year of life are not available. Data concerning the optimal time for     starting solid foods are missing as well as information concerning the ideal composition of     complementary food. In this context it is essential to meet the special nutritional needs of     Ex-Preemies on the one hand and avoid overfeeding and later obesity on the other hand. So     far it remains unclear, what the safe time point for introduction of solid food to     premature infants is and whether this time point influences growth, body composition,     neurodevelopmental outcome or the incidence of atopic disease.   "
112795|NCT01809535|"     Endoscopic variceal ligation (EVL) has proved to be effective in the prevention of esophageal     variceal rebleeding. However, the optimal interval of EVL remains unclear. Our previous     studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low     incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL     ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of     1-2 weeks. So far the optimal treatment interval remained unknown. The investigators     hypothesis the Monthly EVL is superior to the Biweekly EVL in the prevention of esophageal     variceal rebleeding in cirrhotic patients.   "
112796|NCT01809522|"     The present study is a multicenter randomized, controlled trial, whose aim is to verify the     effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical     prostatectomy on early recovery of urinary continence.   "
112797|NCT01809509|"     Pilot study on molecular quantitation and sequencing of endometrial cytokines gene expression     and their effect on the outcome of in-vitro fertilization (IVF) Cycle   "
112798|NCT01809496|"     The purpose of this study is to examine the effect of enhanced patient-centered counseling     (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid     outcomes.   "
112799|NCT01809483|"     This research aims to compare between bandage contact lens and pressure patching in reducing     size of erosion area and pain scale in corneal erosion patients as well as its complications.   "
112800|NCT01809470|"     The study is investigating the metabolic response to playing competitive non-violent and     competitive violent video games. The primary hypothesis is that the metabolic response in the     violent game group will differ from the other two groups, due to activation of the stress     response. The investigators are using an experimental approach, whereby 72 young men are     randomised to one of three groups: watching television (TV), playing the non-violent video     game 'FIFA2013', or playing the violent video game 'Call of Duty'. Participants arrive     fasted, and are given a standardised breakfast. After measurements of weight, height and     waist girth, they then are assigned to one of the three groups. Baseline blood pressure,     heart rate and appetite/mood data are collected, along with a saliva sample for measurement     of the 'stress' hormone, cortisol. The investigators will collect these data again at 4     time-points during the one hour game-playing session. At the end of the study, the allow the     participants half an hour of rest, during which they can choose from a variety of sweet or     savoury snacks. The investigators will compare the data from the three groups, to test     whether changes in blood pressure, heart rate and salivary cortisol, as well as snack     consumption, are greater in the group playing the violent game.   "
112801|NCT01809457|"     to investigate the effectiveness of the educational poster regarding knowledge of dental     trauma for the secondary school students   "
112802|NCT01809444|"     The aim of this study is to compare the efficacy and safety of prednisone versus     sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe     Graves' Orbitopathy (GO).   "
112803|NCT01809431|"     The purpose of this study is to determine whether a 14 week intervention is successful in     improving outcomes for women with gestational diabetes mellitus and their infants.   "
112804|NCT01809405|"     To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual     Function(QSF) version in Korean language of the cancer patients.   "
112805|NCT01809392|"     Allo - hematopoietic stem cell transplantation is currently the only way to cure     myelodysplastic syndrome /acute leukemia . The existing experimental results showed that     decitabine and 5-azacytidine up-regulated the expression of tumor Ags on leukemic blasts in     vitro and expanded the numbers of immunomodulatory T regulatory cells in animal models.     Reasoning that decitabine might selectively augment a graft versus leukemia effect, the     investigators used decitabine administration after allogeneic stem cell transplantation to     studied the immunologic sequelae.   "
112806|NCT01809379|"     This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure     chemotherapy in women with recurrent ovarian cancer   "
112807|NCT01809366|"     Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases     uterine receptivity.   "
112813|NCT01809288|"     Background:      - Rates of diabetes and heart disease in women are increasing. Early recognition of risk     could help women live longer and healthier lives. Race and ethnicity may affect the best     kinds of tests to use to screen for these conditions. Researchers want to compare risk     factors for diabetes and heart disease in African, African-American, and white women. Doing     so may help identify the most effective screening test for each group. This study will look     at healthy African, African-American, and white women who are federal employees and     contractors.      Objectives:      - To study risk factors for diabetes and heart disease in African, African-American, and     white women.      Eligibility:        -  Healthy African, African-American, and white women between 30 and 65 years of age who          are federal employees or contractors.        -  For this study, African women must be born in Africa and have immigrated to the United          States, and report that both parents are Africans. African-American women must          self-identify as African-Americans, born in the United States, and have parents who both          self-identify as African-American born in the United States. White women must          self-identify as white and have parents who also self-identify as white.      Design:        -  Participants will have four visits to study their risk factors for diabetes and heart          disease.        -  The first visit is a screening visit. Participants will be screened with a physical exam          and medical history. Blood and urine samples will be collected. They will also have an          EKG test. Participants will also be shown how to fill out a 3-Day Food Record and wear          an activity monitor called an accelerometer. The food record will keep track of how much          participants eat for 3 consecutive days, including 1 non-working day. The accelerometer          device will be worn for 3 days to monitor movement.        -  At the second visit, participants will have blood tests, an oral glucose tolerance test,          and body fat measurements. They will also fill out questionnaires, review the food          record, and have two imaging studies.        -  At the third visit, participants will have a longer glucose tolerance test. During the          test, participants will receive both glucose and insulin and blood samples will be          collected over several hours. Participants will receive lunch at the clinical center          after the test.        -  At the fourth visit, participants will have a meal test. They will fast for 12 hours          before the test. Participants will eat a specific meal and have blood samples taken          during and after they eat.        -  Participants will discuss the results of these tests with the study doctors.   "
112814|NCT01809275|"     The purpose of this study is to evaluate the safety profile and to obtain an indication as to     the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to     severe Crohn's Disease.   "
112815|NCT01809262|"     Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744     CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI     1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for     additional PK assessments which are not defined as primary or secondary endpoints.   "
112816|NCT01809249|"     Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has     emerged as an option to the traditional deceased-donor transplantation procedure. But there     is an essential risk related to liver resection for healthy donors.   "
112817|NCT01809236|"     This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30 BRVO     and 30 CRVO, respectively) are enrolled in the study. The study included a fixed treatment     period (3 months) and a PRN period (6 months). In the fixed treatment period patients will     receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN period, patients     are monthly visited and retreatment will be needed according to the retreatment criteria     pre-specified.   "
112818|NCT01809223|"     This study is design to evaluate the effect of conbercept therapy on visual acuity and     anatomic outcomes compared to sham injection and durability of response observed in subjects     with choroid neovascularization secondary to pathological myopia.   "
112819|NCT01809210|"     This is a Phase I, open label multicentre study of selumetinib administered orally in     combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC.     The study has been designed to allow an investigation of the optimal dose of selumetinib in     combination with various standard first line double-platinum chemotherapy regimens. Initial     assessment will be based on tolerability of selumetinib in combination with one or more     selected regimens that are considered to be tolerated also being assessed for preliminary     evidence of activity.      This study is a dose finding and optional cohort expansion; In addition all patients will be     assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.   "
112820|NCT01809197|"     The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared     for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to     Acuvue® Oasys® lenses cared for with habitual MPDS.   "
112821|NCT01809184|"     This trial is conducted in Europe. The aim of this first human dose trial is to investigate     the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body)     and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287     (insulin 287) in a GIPET® I tablet formulation in healthy subjects.   "
112822|NCT01809171|"     The third generation oral aromatase inhibitors (AIs) are increasingly being used in the     management of estrogen receptor positive breast cancer. One of the issues related with     administration of oral AIs is their side effects, particularly on the musculoskeletal system.     Although the prevalence and importance of arthralgia and myalgia occurring in BC patients     receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating     symptoms are unknown.      In this project, we aim to unravel the interaction between vitamin D and musculoskeletal     adverse events experienced by AI users. We will also evaluate how vitamin D supplementation     affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a     randomized placebo-controlled double blind clinical trial. We will assess changes in the     musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and     also monitor serum IGF-I and estrogen levels together with bone resorption and formation     markers.   "
112823|NCT01809158|"     Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom     dimensions. The negative symptom dimension, with its protean cognitive manifestations,     responds poorly to treatment, which can be a particular challenge in countries where     clozapine therapy is not available. Preliminary data indicates that minocycline may be     beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive     symptoms. Persons with schizophrenia or schizoaffective disorder and recent onset     schizophrenic episode or recent relapse who are prescribed minocycline in addition to     standard antipsychotic medication will show greater symptom reduction, as measured by the     Positive and Negative Syndrome Scale (PANSS) total score.   "
112824|NCT01809145|"     The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to     metals, in Sarcoidosis patients with occupational exposure.   "
112843|NCT01808885|"     This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group,     multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when     administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple     Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1     ratio.   "
114101|NCT01792388|"     Increased Intestinal Permeability is detectable in clinically active Crohn's disease, in     stable Crohn's disease and is predictive of clinical relapse. Maintenance of the epithelial     barrier integrity is therefore essential for intestinal homeostasis. Vitamin D may have a     critical role in improving barrier function.   "
112825|NCT01809132|"     This study will compare two different treatments of acute alcoholic hepatitis. The current     standard of care is treatment with corticosteroids (methylprednisolone). This will be     compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will     be treated and followed for 6 months and the two treatment groups will be compared for     differences in death rates and laboratory tests that measure liver and gut function.   "
112826|NCT01809119|"     Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm.     With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are     being commonly diagnosed and treated. The partial open nephrectomy is still considered the     gold standard technique for nephron sparing surgery, especially when the surgeon is not     experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally     invasive techniques were developed, including the laparoscopic partial nephrectomy. The     objective of this study is compare the partial laparoscopic nephrectomy to open partial     nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced     randomized prospective trial will be conducted. One group of patients will be submitted to to     open partial nephrectomy while the other group of patients will be submitted to laparoscopic     partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary     to determine the differences in outcomes between them and if the laparoscopic partial     nephrectomy can be performed without harms to the patients.   "
112827|NCT01809106|"     Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life     of patients and a high incidence, with values around 70-90% in advanced and metastatic     stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are     the guidelines produced by the World Health Organization (WHO). This document shows that the     use of opioid drugs is the mainstay of treatment, with particular reference to opioids     major (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in     Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the     data currently available, have an analgesic effect would partly overlap but with different     percentages of non-responders (NR), a different need to increase the dose over time to     maintain adequate analgesia, a different action to the switch to another molecule for     ineffectiveness analgesic. The observations described suggest that opioids, although they     belong to the same family drug may not be fully comparable with regard to the clinical     effects products. Important differences are known on the pharmacokinetic and pharmacodynamic     and, more recently, also in terms of pharmacogenomics. This is a comparative study of     analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible     differences in terms of analgesic efficacy, changes in dose over time, use of switch or     permanent abandonment of treatment, parallel to the contour of the side effects. The     associated sub-project will link the structure gene of patients and clinical results have     emerged.   "
112828|NCT01809093|"     You are being asked to be in a research study to determine blood levels and vitreous levels     of compounds called thrombospondin 1 (TSP1) and pigment epithelium derived factor (PEDF).     These compounds exists naturally in your body.   "
112829|NCT01809080|"     Retrospective studies have established a strong correlation between reports of life stress     and depression. Investigators have begun to further explore this relationship by examining     the role of gene x stress interactions in the pathogenesis of depression. In a recent     landmark study, Caspi and colleagues (2003) reported an interaction between a serotonin     transporter promoter polymorphism and life stress in the development of depression. This     finding has been replicated in some but not all follow up studies. Despite the initial     promise of these results, the ability to draw definitive conclusions is compromised by     significant study design limitations: 1) retrospective design 2) a focus on acute rather than     chronic stress 3) substantial variation in the character and intensity of stress between     subjects. Medical internship is a period filled with predictable and high levels of chronic     uncontrolled stress. Rates of depression among interns are elevated compared to the general     population. In this study, we aim to utilize the predictable and consistent stress of     internship to investigate the relationship between stress, genes and depression with a     prospective study design that bypasses some of the pitfalls of previous studies.   "
112830|NCT01809067|"     Research Question:      What effect if any does the use of lavender aromatherapy have on a patient's stress and     anxiety during the MRI procedure in the Cardiovascular Services Department?      Hypothesis:        1. The use of lavender aromatherapy will reduce anxiety by 20% during MRI procedures.        2. MRI cancellations related to stress and anxiety will decrease by 10%.      Sample size of 30 patients is needed for the control group and the lavender aromatherapy     group, for a total of 60 patients.      Rationale:      Patients undergoing MRI procedures may experience stress and anxiety related to the small and     confining space required during the scan. Anyone with a history of claustrophobia, panic     attacks, or fear of enclosed spaces is more likely to experience symptoms of panic, fear, or     anxiety during the MRI procedure (Harris, Cumming, & Menzies, 2004, p. 1). This stress and     anxiety may cause the patient to abort the scan, the patient may refuse future scans, or the     patient's nervous tremors or involuntary quivering may adversely affect the images obtained.     Lavender aromatherapy has been shown to reduce stress and anxiety for patients in other     settings; however, its use during MRI procedures has not been studied.      This project investigates the use of lavender aromatherapy as a non-pharmacological way to     help patients relax during their MRI procedure. Lavender aromatherapy has been studied and     shown to reduce stress and anxiety for patients in other situations, but it has not been     studied during MRI procedures. Lavender is known to be uplifting, as well as soothing and     helpful for reducing stress, anxiety, depression, and insomnia (Herz, 2007, p. 264). If     aromatherapy proves useful as an agent to reduce stress and anxiety, patient satisfaction     with their MRI procedure will increase and the need for sedating medication could decrease.   "
112831|NCT01809054|"     This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to     detect changes in coagulability following elective total knee and hip arthroplasty. Patients     will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:        1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325          mg for 5 weeks, or        2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc.,          Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.   "
112832|NCT01809041|"     Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon.     Most patients will receive general anesthesia during surgery. Two groups of general     anesthetics are used for this purpose. We hypothesize that the incidence of POCD is not     different in patients received intravenous anesthetics only or sevoflurane (a volatile     anesthetic-based general anesthesia for their major intra-abdominal surgery.   "
112883|NCT01808365|"     This carriage study aims to evaluate the presence of meningococcus in Asian populations (and     potential for disease) and explore the extent and serogroup distribution of meningococci     circulating in the population.   "
112884|NCT01808352|"     Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client     Centered Care Coordination (C4)Component.   "
112833|NCT01809028|"     This study will test the amount of tissue, called cell block, obtained from your pancreas.     Patients who are asked to participate in this study have a growth (mass) in the pancreas that     needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number     of times the doctor biopsies the mass), at this time we do not know the ideal number of     passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this     study is to compare the amount of tissue obtained with 2 passes versus 4 passes.   "
112834|NCT01809015|"     Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established     therapy for both prevention and treatment of thromboembolism in daily clinical routine.     Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an     increasing complexity of medical therapy. However, data on quality and management of VKA     therapy with phenprocoumon in current medical care are limited. Our aim was to investigate     the quality of OAC with VKA in current health care and to evaluate the potential for     improvements.      The investigator-initiated thrombEVAL study program comprises two cohorts of patients treated     with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a     multicentre cohort of patients in regular medical care and a multi-local, single centre     cohort of patients in a telemedicine-based coagulation service. The study program is expected     to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts build on a     detailed clinical assessment of participants and anticoagulation therapy at study enrolment.     Subsequently active and passive follow-up investigations are carried out to document and     validate complications of the treatment. Primary short-term outcome is the distribution of     time in therapeutic range; the primary long-term outcome comprises the composite of stroke,     systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.   "
112835|NCT01809002|"     Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and     functional outcomes for the repair of nerve injuries in the hand.   "
112836|NCT01808989|"     The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the     buttocks and chest level during walking. Before and after exercise the diagnosis,     investigations and treatments ongoing or to be performed are recorded.      The present study focuses on the clinical interest of the transcutaneous oxygen pressure     during exercise in the diagnosis of claudication in patient referred for an oximetry exercise     test.   "
112837|NCT01808976|"     Over two million people in the US download health apps onto their smartphones and tablets,     with the intent of improving their quality of life. Despite widespread use of these apps,     there is relatively little information regarding app user access (do users download health     apps and use them more than once), app user engagement (do users follow the app protocols)     and app impact on mood, cognition and daily functioning. Our long-term goal is to conduct a     future randomized controlled trial investigating access, engagement and impact of two types     of mental health apps, apps based on evidence-based therapeutic principles (i.e.: Problem     Solving Therapy) and apps based on cognitive neuroscience principles of depression (i.e.: a     cognitive training game called Evolution) and compare both to an information only app. Our     intent is to conduct this study entirely on mobile devices, in order to investigate access,     engagement, and impact in an ecologically valid manner. The purpose of this pilot study is to     test the feasibility of conducting our future randomized controlled trial comparing three     mobile mental health apps for the management of depressed mood, improvement of cognitive     control, and improvement in activities of daily living in people aged 18 and older.     Recruitment, consent, randomization, app use and outcome assessment will be conducted     entirely on mobile devices. We will recruit 150 people through four different recruitment     avenues to determine which avenue results in the most representative sample of our target     population (people 18 and older who have symptoms of depression that are interfering with     their quality of life). We will also determine the number we need to recruit to have a final     sample of 150 people willing to be randomized between the 3 apps and complete an 12-week     study of app impact on mood, cognition and function. This pilot will provide information on     the completeness of data from a study conducted in this manner, and uncover any other     challenges we may face by using mobile devices for data collection, and if we will find     differential drop out between app type (e.g.: will more people stop using of the information     only app prematurely?). Although we will not have sufficient statistical power to answer     questions about comparative effectiveness between the apps, we plan to explore relationships     between sample demographics, app use, and improvement in cognitive control on improvements in     mood and function.   "
112838|NCT01808963|"     To evaluate the utility of respiratory heat loss measurements as a physiologic monitor.   "
112839|NCT01808950|"     The primary objective is the observation and description of the preliminary efficacy of     resiquimod gel 0.06% on a single nodular basal cell carcinoma (nBCC) in a small group of     patients.   "
112840|NCT01808937|"     The Morphea in Adults and Children (MAC) cohort is the first registry for both children and     adults with morphea (also known as localized scleroderma) in the country. The purpose of the     registry is to learn more about morphea, specifically:        -  How morphea behaves over time        -  How frequently specific problems occur along with morphea (for example, arthritis)        -  Whether morphea has an autoimmune background   "
112841|NCT01808911|"     CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid     combined with rituximab in patients with acquired haemophilia. The study will test the     hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus     rituximab for FVIII inhibitor eradication in acquired haemophilia.   "
112842|NCT01808898|"     The usual intervention to control the pain during an outpatient endometrial ablation has been     to use local anaesthesia (LA) injection just in the neck of the womb (cervix). However, this     alone may not be sufficient to control the pain completely. Therefore, we want to find out     whether an injection of LA given deep into the muscle of the womb (myometrium), in addition     to that in the cervix, has a better effect on controlling the pain during the procedure.      All women attending gynaecology outpatient clinics, who have consented for an outpatient     hysteroscopic procedure, will be invited to take part in the study. The study will be carried     out in the outpatient hysteroscopy clinic at Birmingham Women's Hospital.      As part of standard pain control method during an outpatient endometrial ablation, all women     will receive an injection of LA in the cervix of the uterus to 'freeze it'. During     hysteroscopy a randomly selected treatment group will receive an injection into deep muscle     containing only normal saline (control group) whereas the experiment group will receive fast     / long acting local anaesthesia (cornual block).      Women will be asked to rate the degree of pain by placing a mark on an ungraduated 10 cm     horizontal line. These scales will be given before the procedure, during LA injection,     immediately after, one hour and at the time of discharge from hospital.      The results will help future patients undergoing a similar procedure to have much better pain     relief and allow many more to have the procedure without the side effects of a general     anaesthetic and its risks. In addition to having less pain, it may reduce the number of     painkillers needed as well as any stay in hospital. In future this may also allow a greater     variety of procedures to be done in an outpatient setting.   "
114102|NCT01792375|"     To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor     induction for nulliparas at term with an unfavorable cervix   "
112844|NCT01808872|"     The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic peptide     (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis and     assessment of the severity of heart failure in point-of-care and laboratory settings. The     purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and     NT-proBNP assays for both whole blood and plasma in the intended use population.   "
112845|NCT01808859|"     The purpose for this study is to investigate the quadriceps (thigh) function preoperatively     and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint)     in a randomised study with or without the use of a Tourniquet (cuff around the thigh during     surgery) (100 mm Hg > systolic blood pressure).   "
112846|NCT01808846|"     To explore whether obese adolescents with insulin resistance and relative low leptin levels     exhibit functional alterations of the neuronal circuits involved in the regulation of energy     metabolism and food seeking behaviors.      We here propose to test the hypothesis that the reward circuitry is dysregulated in obese     adolescents and is related to the degree of insulin resistance and hyperinsulinemia.   "
112847|NCT01808833|"     The investigators hypothesize that frailty assessment prior to concurrent chemotherapy and     radiation therapy in the elderly will predict treatment-related toxicity and morbidity and     that such assessment at serial time points will help improve treatment and outcomes for these     patients.   "
112848|NCT01808820|"     Dendritic Cell vaccine manufactured and partially matured using our standard operating     procedures, developed in collaboration with the HGG Immuno Group, then administered through     imiquimod treated skin will be safe and feasible in patients with high grade glioma. This     will result in anti-tumor immunity that will prolong survival of subjects treated. Study     treatment will correlate with laboratory evidence of immune activation.   "
112849|NCT01808807|"     To elucidate the audit's effect on caesarean section rate, and also define the factors     influencing the caesarean section rate.      From Jan 2007 , pregnant women who delivered in a medical center will be included     retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the     indications of cesarean section, began from July 2008. Clinical data, indications of cesarean     section, and perinatal outcomes were compared between the cases of before and after the     audit. Multivariate logistic regression was performed to identify factors affecting cesarean     section rate.   "
112850|NCT01808794|"     The purpose of the study is to compare one material called Mucograft with another material     called Dynamatrix. These materials are used as a type of a barrier (made from pig material     also known as porcine material) in a preservation technique to increase the thickness and     width of tissues at a tooth extraction site. The investigators want to see if one works     better than the other or if they work equally as well. These materials are made up of     collagens, which are naturally occurring proteins found in the skin, specifically connective     tissue. Dynamatrix is made up of many types of collagens whereas Mucograft is only made of     fewer collagens. These materials have been given something called a 510(k) status by the FDA.     This means that the FDA determines them to be equivalent to another product that they have     previously approved. You will be put into one of two groups at random, and will not know     which one you are in. Like flipping a coin, you will have a 50/50 chance to be in either one     of the two groups. You will either be in a group using Mucograft or in a group using     Dynamatrix. Both of these materials are regularly used in the dental clinics.   "
112851|NCT01808781|"     The purpose of this study will be to find out the effect of two different interventions on     muscle strength, ability to produce muscle force quickly (power), daily function, and number     of steps and physical activity an individual with total knee replacement do daily.      The research hypotheses for this study will be as follows:        -  For individuals who are at least 6 months post-total knee replacement, home-based          high-velocity training exercises will result in significantly greater improvements in          muscle strength and power compared to those who receive a walking program only.        -  For individuals who are at least 6 months post-total knee replacement, home based          high-velocity training exercises will result in significantly greater improvements of          daily function(eg. sit to stand, climb a set of stairs)than those who receive a walking          program only.        -  For individuals who are at least 6 months post-total knee replacement, home based          high-velocity training exercises will result in significantly greater improvements in          physical activity behavior (eg. number of steps per day)compared to those who receive a          walking program only.   "
112852|NCT01808768|"     To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or     specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.   "
112853|NCT01808755|"     Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic     regimes do not change the long term risk of recurrence.      Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to     evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs.      Design, setting and participants- : In this crossover trial female patient were eligible for     the study if they had recurrent UTIs, that is three ore more episodes during the preceding 12     months. Suitable patients were randomly assigned to antibiotic treatment with     trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received     the other intervention in the second phase of the study.      Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain     (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at     the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as     mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for     paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and     number of voidings between treatment. Data analysis was performed with STATA statistical     package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).   "
112940|NCT01807624|"     The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of     a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline     with blood draws over 24 hours.   "
113033|NCT01806415|"     This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable     healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to     observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in     groups of healthy individuals and to compare the side effects and tolerability of a single     dose of fenobam with placebo.   "
112854|NCT01808742|"     myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive     facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience     Cryo-Touch III device uses well-established principles of cryobiology to cause localized     reduction in muscle activity resulting in a reversible reduction in facial animation and the     appearance of facial lines. The device operates on well-established cryobiology principles;     that localized exposure to controlled low temperature conditions can alter tissue function.     The therapy treats targeted motor nerves with low temperatures via a cold probe in the form     of an assembly of small diameter needles, creating a highly localized treatment zone around     the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction     resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch,     Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety     for applications in this indication. The goal of the study described herein is to investigate     optimized algorithms and ongoing safety and effectiveness.   "
112855|NCT01808729|"     The purpose of this project is to see if heritable alterations in the function, biology and     vascular repair capacity of vascular cells make a major contribution to the burden of     coronary artery disease (CAD), fibromuscular dysplasia (FMD), and other vascular diseases.      In more detail, FMD is a nonatherosclerotic vascular disease that primarily affects women     aged 20 to 60. It commonly affects the renal and carotid arteries but may involve almost     every artery in the body. At the cellular level, FMD is characterized by increased fibroblast     proliferation and collagen deposition. This study aims to define some of these cellular     problems by directly studying fibroblast cells from FMD patients and healthy control     subjects. Similarly, CAD is among the leading causes of death worldwide. However, a large     part of the risk for CAD is unexplained. It is thought that a major but undefined risk factor     may be gene (genomic) variations causing a change in vascular cell function. Here, we will     study important vascular cell types in patients with severe and early onset CAD in an attempt     to define these problems. Therefore, in summary, this study will look to define the various     cellular-level problems that occur in patients with both in CAD and FMD. These data will be     linked to DNA-level analyses to ultimately attempt to define the cause of these conditions.   "
112856|NCT01808716|"     The study hypothesis is a decreased muscle damage induced by exercises when low-level laser     therapy is applied on body muscles before exercises.   "
112857|NCT01808703|"     The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch)     applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs     of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone.     Eighty patients with advanced gum disease will be recruited and treated within this clinical     trial. Patients will be evaluated for changes in gum measurements over a 12-week period.   "
112858|NCT01808690|"     Diabetes is increasingly common among youth, forecasting early complications. Type 1 (T1D)     cause early heart disease, shortening lifespan despite modern improvements in control of     blood sugars and other risk factors for heart disease. Poor insulin action, otherwise known     as insulin resistance (IR), is the main factor causing heart disease in type 2 diabetes     (T2D), but the cause of increased heart disease in T1D is unclear. IR may contribute to heart     disease in T1D as in T2D, as the investigators and others have found the presence of IR in     T1D. Much less is known about IR in T1D, but a better understanding of its role in T1D is     critical to understanding causes of heart disease in T1D. The investigators long-term goal is     to understand the early causes of heart disease in diabetes so that we can prevent it. The     investigators unique initial findings suggest that even reasonably well-controlled, normal     weight, T1D youth are IR. The IR appears directly related to the heart, blood vessel, and     exercise defects, but in a pattern that appears very different from T2D. The goals of this     study are to determine the unique heart, blood vessel and insulin sensitivity abnormalities     in T1D youth, and determine whether metformin improves these abnormalities. A clear     understanding of these factors will help determine the causes, and what treatments could help     each abnormality.      Hypothesis 1: Metformin will improve insulin function and mitochondrial function in T1D.      Hypothesis 2: Metformin will improve vascular and cardiac function in T1D.      All measures will be performed twice, before and after a 3-month randomized,     placebo-controlled design where subjects are randomized to either metformin or placebo. The     independent impact of insulin action as well as glucose levels, BMI, T1D duration, and gender     on baseline outcomes and the impact of changes in insulin action, glucose levels and BMI on     response to metformin will also be examined to help customize future strategies to prevent     heart disease in T1D. This study will advance the field by providing new information about     the role of poor insulin action in the heart disease of T1D, and whether improving insulin     action in T1D is helpful. If a focus on directly improving insulin action in T1D youth is     supported by our studies, the clinical approach to T1D management may significantly change.   "
112859|NCT01808677|"     The goal of this research study is to learn more about the safety of treating NSCLC with     reirradiation using standard methods and to look for ways to lessen side effects and improve     therapy. Reirradiation is when radiation is given to an area of the body that has previously     received a full dose of radiation.   "
112860|NCT01808664|"     In this study, the investigators will develop and evaluate a novel intervention using     standardized patients (SPs) -- or actors playing the roles of patients -- to enhance     physicians' patient-centered counseling skills regarding two frequently overused, potentially     inappropriate services in primary care: magnetic resonance imaging (MRI) for acute low back     pain and bone densitometry in women at low-risk for osteoporosis. The investigators will     further evaluate whether intervention effects on physician patient-centeredness generalize to     counseling regarding other costly, unnecessary diagnostic tests.   "
112861|NCT01808651|"     This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the     treatment of MDD in adult Japanese participants.      Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#:     NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an     additional 52 weeks.   "
112862|NCT01808638|"     The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic     cancer disease by combining the new investigational medicinal product Atu027 with the     standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s     anti-tumor activity with Atu027.      The objectives of this clinical trial are to evaluate safety and activity of two Atu027     schedules in combination with standard gemcitabine treatment in patients with advanced or     metastatic pancreatic adenocarcinoma.   "
112954|NCT01807442|"     The purpose of the study is to understand peoples' positive emotions, like how optimistic or     grateful they feel, after they have had a heart problem. The investigators want to determine     whether positive emotions affect peoples' ability to follow recommendations, like following a     healthy diet, exercising, and taking medication.   "
112955|NCT01807429|"     the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on     pain control in trauma patients with closed limb fracture(s); and also compared the incidence     of adverse events (mainly cardio pulmonary ) between two groups.   "
113034|NCT01806402|"     The purpose of the study is to repeatability, reproducibility and agreement of eye     measurements in retina and glaucoma patients.   "
112863|NCT01808625|"     Radiotherapy is the mainstay of treatment for brain malignancies and is associated with     significant neurotoxicity. Due to continuous increase in patient's survival, the long term     risk for radiation-induced brain inflammation and necrosis inducing secondary cognitive     impairments are increasing concerns. Currently there is no effective treatment for preventing     long term radiation-induced brain damage.      Hyperbaric oxygen therapy (HBOT) is the administration of high oxygen concentrations within a     pressurized chamber to increase the cellular/mitochondrial delivery of oxygen. Oxygen     stimulation by HBOT has become the definitive therapy for radiation-induced damage to soft     tissues and bone due to its ability to stimulate healing processes by supplying the     energy/oxygen needed while down-regulating genes involved in inflammation. Oxygen stimulation     by HBOT is currently indicated for patients with overt radiation-induced neurotoxicity and     was proven to reduce further development of radiation damage while stimulating idling     neurons to return to function. Since HBOT is considered safe, we hypothesize that its     application following radiation, before the manifestation of neurological side effects, may     help avert development of early/delayed onset radiation-induced neurotoxicity.      In the proposed study, for the first time, HBOT will be applied early after radiation to     prevent the expected decrease in patients neurocognitive functions (NCF) and improve their     quality of life (QOL). The study is designed to provide statistically significant assessment,     in a prospective randomized clinical trial, of the effect of oxygen stimulation applied soon     after brain radiotherapy, for patients with primary and secondary brain tumors, on patients     QOL and NCF. In addition, advanced imaging methodologies will be applied to study the     feasibility of quantifying oxygen stimulation effects on the tumor and surrounding brain     tissue.   "
112864|NCT01808612|"     The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in     Japanese adult participants with Major Depressive Disorder (MDD).   "
112865|NCT01808599|"     Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed     by maintenance therapy with subcutaneous Rituximab in patients with histologically proven     diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any     extranodal site, either de novo, or relapsed following local therapy (including surgery,     radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).   "
112866|NCT01808586|"     A) Background Chronic neck pain is a significant and common issue which is difficult to     treat. Tight bands of muscle (trigger points) can be a source of chronic neck pain and they     are sometimes injected to manage chronic neck pain. However, these injections seldom lead to     significant, long-lasting relief. In some cases, these trigger points may originate from     injury or damage to a specific joint in the neck (the facet joint). Treatment of this joint     with cortisone injection may lead to improved pain relief and function.      B) Hypothesis By injecting the facet joint with cortisone, the pain associated with tight     bands of muscle in the neck and shoulders will be relieved to a greater extent than that     attained through trigger point injection.      C) Methods Patients with neck pain will have a test to determine if any pain originates from     the facet joint. Among those who have significant pain from these joints, a comparison     between the effect of cortisone injection into these joints versus injection into the trigger     points will be evaluated.      D) Expected Results and Significance      It is expected that injection with cortisone into the facet joints will lead to improved pain     and function when compared to that attained from trigger point injection. In addition, the     number of trigger points, and the pain and headache that originate from these trigger points,     are expected to decrease with cortisone injection into the facets to a statistically and     clinically significant extent. Results from this pilot study will then influence the design     of future trials into chronic neck pain treatment, leading to better clinical     recommendations. A peer-reviewed publication and conference presentations will facilitate     dissemination.   "
112867|NCT01808573|"     This is a randomized, multi-center, multinational, open-label, active-controlled, parallel     design study of the combination of neratinib plus capecitabine versus the combination of     lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2     directed regimens in the metastatic setting.   "
112868|NCT01808560|"     The purpose of this pilot feasibility study is to assess whether treating meibomian gland     dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual     quality and ocular comfort after cataract surgery.   "
112869|NCT01808547|"     The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of     topical administration of ISV-303 compared with Durasite Vehicle.   "
112870|NCT01808534|"     This phase II trial studies how well palifosfamide works in treating patients with recurrent     germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing   "
112871|NCT01808521|"     In this study, the investigators want to determine if N-acetylcysteine(NAC), given     intravenously, will decrease complications in patients with Thrombotic Thrombocytopenia     Purpura (TTP) who are receiving treatment with therapeutic plasma exchange (TPE). The     investigators want to determine, through anti-oxidant activity, if NAC will have additional     efficacy in TTP by improving cleavage of the patients' VWF by ADAMTS13, and preventing     propagation of platelet/VWF strings. This will be manifest by a more rapid improvement in the     patient's platelet count, decrease in number of days requiring TPE, and decrease in     microvascular thrombotic complications. The investigators will additionally: 1) Assess safety     of NAC by evaluating subjects for adverse events and significant adverse events 2) Determine     effects on TTP by measuring clinical and research laboratory values 3) Determine drug effects     by measuring clinical and research laboratory values.   "
112872|NCT01808508|"     Many individuals with Down syndrome (DS) have breathing problems during sleep. This is called     obstructive sleep apnea syndrome (OSAS). OSAS is very common in individuals with Down     syndrome because of the shape of their face and tongue and because of their low muscle tone.     OSAS can cause a lot of health problems including behavioral and learning problems as well as     heart problems.      The purpose of this research study is to look at the effects of treating OSAS in individuals     with Down syndrome with a machine called Continuous Positive Airway Pressure (CPAP). The     investigators want to see if treatment of OSAS improves learning, behavior and heart     problems.   "
112873|NCT01808495|"     The purpose of this study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human     Corneal Fibroblasts under treatment of mitomycin C (MMC).   "
113020|NCT01806584|"     A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard     practice treatment in extending the duration of primary patency after arteriovenous graft     surgery in subjects with end-stage renal disease.      It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin     matrix containing endothelial cells can provide a continuous supply of multiple growth     regulatory compounds to the underlying cells within the blood vessel, while being protected     from the effects of blood flow in the vessel(s) or complications resulting from being in     direct contact with the point of injury.   "
112874|NCT01808482|"     This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will     enrol healthy volunteers and Part C (open-label) will enrol RRMS patients. Parts A (single     ascending dose) and B (repeat ascending dose) will assess safety, tolerability, PK and PD of     GSK2618960. Part C (repeat doses) will assess safety, tolerability, PK, PD, immunogenicity,     paraclinical (magnetic resonance imaging [MRI] lesion counts) disease activity and markers of     Th1 and Th17 mechanisms.      Part A: Each of the 24 healthy volunteers (divided in 5 groups), will take part in only 2 of     the planned 8 dosing sessions (A-active, P-placebo). Subjects in each group of Part A will be     randomized in a 2:1:1 ratio to one of the following sequences: AA, AP or PA such that in each     dosing session they will receive study treatment in a 3:1 ratio of active: placebo     respectively.      Part B: Dosing levels and regimen are dependent upon safety tolerability and PK/receptor     occupancy (RO) data from Part A. In Cohort 1, 12 subjects will be randomized in a 3:1 ratio     to A or P. Each subject will receive the same study treatment for repeated doses. If the     duration of full RO from highest dose in Part A is less than 4 weeks, a second cohort of 12     subjects in Part B may be recruited, based on Dose Escalation Committee (DEC) decision Part     C: The 20 RRMS patients will be assigned to active treatments for 2 to 4 repeated doses.      Safety/tolerability and PK data monitoring and the decision to proceed to the next dose level     of GSK2618960, and the decisions to proceed to Part B and Part C of the study will be made by     a dose escalation committee.   "
112875|NCT01808469|"     The purpose of this study is to determine the safety, tolerability and distribution and     elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition     its effects on some inflammatory parameters will be measured in presence or absence of     lipopolysaccharide stimulation.   "
112876|NCT01808456|"     Influenza infection in recipients of solid organ transplants recipients while on maintenance     immunosuppressant therapy is associated with increased morbidity and mortality. Although     influenza vaccination is recommended in these high-risk patients, safety and immunogenicity     of commercially available different strengths of influenza vaccine have not been established.      The primary study objective is to determine the safety and immunogenicity of Fluzone and     Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of     two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are     commercially available for use in the general population. Fluzone is approved for use in 6     months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and     older.      This is an exploratory, open-label, parallel group, observer blinded, prospective study. All     recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at     least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be     eligible for enrollment.      Enrolled patients will be followed for three months (a total of 4 visits) following     enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and     12.   "
112877|NCT01808443|"     The purpose of this study is to test the efficacy of laser versus cryotherapy on the     treatment of warts   "
112878|NCT01808430|"     This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS)     for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers     45 mm and/or 60 mm (study devices).   "
112879|NCT01808417|"     This research study is a Phase I clinical trial. Phase I clinical trials test the feasibility     and safety of an investigational technique or drug. This study will try to define an     appropriate dose of the investigational drug indocyanine green (ICG) in combination with near     infrared (NIR) imaging to use for further studies. Investigational means that this drug,     ICG, is approved by the FDA for other imaging uses, but not for lymphatic mapping using NIR     light. Its use for following lymphatic pathways from tumors in the human body is still being     studied and research doctors are trying to find out more about it. It also means that the FDA     has not approved ICG mapping for your type of cancer.      ICG is a dye and is approved for testing liver function and measuring blood flow from the     heart. This drug has been used in studies to map lymphatic pathways in lung cancer and breast     cancer and information from those other research studies suggests that this dye may help to     identify lymph nodes associated with your esophageal tumor in this research study. ICG can be     detected within the body using special near-infrared light cameras. In this research study,     the investigators are looking at how easily ICG can get to the first lymph node (called the     sentinel lymph node or SLN) associated with your esophageal tumor and whether the     investigators can see the path of the ICG and the respective SLN using a near infrared     camera.   "
112880|NCT01808404|"     College counseling centers (CCCs) are being faced with increasing demands for services to     meet the treatment needs of their students, in the context of increasingly severe cases and     declining resources. Innovative, cost effective solutions are needed.      The proposed project seeks to meet these needs by testing a web-based guided self-help     version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic therapy     found to effectively treat a range of psychological problems. An ACT program would provide a     means of implementing effective treatment for the range of problems in the CCC setting, while     the guided self-help format would reduce counselors' workload, improving cost-effectiveness     and reducing waiting lists. This would both treat students and train counselors in how to     implement the ACT intervention. Three self-help lessons have been developed, as well as a     counselor portal to review students' use of the program and to receive training on     implementing ACT guided self-help.      The study is a pre-post, open(i.e., non-randomized) feasibility trial with 20 counselors and     60 clients from multiple CCCs throughout the country.   "
112881|NCT01808391|"     This is a prospective, multicenter, historical controlled study. The present clinical study     will measure non-inferiority of 12 month TLF rate compared to historical control.The selected     historical control is the Xience V arm from RESOLUTE All-Comer clinical study, that study is     a prospective, multicenter, randomized, two-arm, international, open-label study.The     historical control did not have angiographic follow up before 12 months, in the present     clinical study, only subjects with clinical follow-up conducted at 12 months without any     pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of     this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up     cohort) will be included in this analysis cohort.   "
112882|NCT01808378|"     Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated     keratopathy   "
112885|NCT01808339|"     This study will investigate the effects of altering the time of day of dosing (morning or     evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a     dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a repeat-dose,     double-blind, randomized, placebo-controlled, three-way crossover study to compare the effect     of morning (AM) and evening (PM) dosing with FF 100 on lung function. Twenty-four male and     female subjects with persistent bronchial asthma will be enrolled to ensure twenty evaluable     subjects. The three treatments will be FF 100 AM (with placebo PM), FF 100 PM (with placebo     AM) and matching placebo (AM and PM). All treatments will be administered for 14 (+/-2) days     with 14 day run-in and 14 to 21 day washout periods. The total duration of the study will be     approximately 13 to18 weeks for each subject.   "
112886|NCT01808326|"     This study is an open-label, single arm, phase II study of chlorambucil in subjects with     previously untreated CLL.      The primary objective is to evaluate the response to chlorambucil in Japanese subjects with     previously untreated CLL.      Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil in     Japanese subjects.   "
112887|NCT01808313|"     This open label, single-arm, non-controlled, multicentre study will determine the effect of     ambrisentan on exercise capacity (6MWT) in Chinese subjects with PAH. The study consists of a     screening period of 4 weeks, a 12-week primary evaluation period (PEP) and a 12-week     dose-adjustment period (DAP). Ambrisentan 5 mg will be administered to eligible subjects for     12 weeks (PEP).   "
112888|NCT01808300|"     A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing     clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and     Thioctic acid after oral administration in healthy male volunteers.   "
112889|NCT01808287|"     The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3     Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems     in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve     replacement.   "
112890|NCT01808274|"     The purpose of this study is to assess the safety and device success of the Edwards CENTERA     Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis     who are indicated for aortic valve replacement.   "
112891|NCT01808261|"     Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients.   "
112892|NCT01808248|"     This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir     (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12     weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have     previously failed prior treatment with an interferon-based regimen.   "
112893|NCT01808235|"     The purpose of this study is to pilot test an intervention to improve oral health for     individuals with memory problems. The results from this study will assist in developing     prevention and intervention programs aimed at maintaining good oral health, or at least     slowing its deterioration.   "
112894|NCT01808222|"     Prostate cancer is the most common solid tumor, with approximately 200,000 new cases     diagnosed per year. Several different local therapies are available for treatment; including     surgery and radiotherapy Significant advances have been made which have improved the cancer     control outcomes and treatment. Despite these significant advances, approximately 30% of     patients treated with definitive local therapy experience recurrent disease. Recurrent     (returning) disease usually displays rising PSA (blood test for prostate cancer). The PSA     level is often of limited use in differentiating local recurrence (i.e. recurrence in the     prostate bed) from recurrence outside of the prostate bed (extra-prostatic recurrence).     Imaging plays a central role in the detection of recurrent prostate carcinoma in the prostate     bed and in the differentiation of prostatic from extraprostatic recurrence. There are newer     methods of imaging such as magnetic resonance imaging (MRI) and positron emission tomography     (PET) with molecular radiotracers that are currently under study for the imaging of     post-therapy recurrence.      One PET radiotracer which has shown promise in the staging and restaging of patients with     prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid     (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher     accuracy compared with other methods in the restaging of patients with suspected recurrent     prostate carcinoma. FACBC has been tested in over 140 subjects in other studies in the Emory     system including 128 subjects with prostate cancer.      The investigators will perform a study with 25 patients in whom the investigators have a     strong suspicion of prostate cancer that has returned to the body after having an initial     treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and     MRI imaging individually then together will be useful in the detection of local and     extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of     the FACBC scan and one week later as required by the FDA.      All patients will undergo biopsy of the prostate as clinically appropriate per standard of     care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer     site(s) will also be biopsied as clinically appropriate. Biopsy of the suspected recurrence     sites will be scheduled at the subjects' convenience as soon as possible after the scans.      Tissue obtained from the biopsy will undergo standard analysis to determine if prostate     carcinoma cells are present. The secondary goal will be to use left-over biopsy material to     determine if there are genotypic differences between prostate carcinoma recurrence confined     to the prostate bed and extraprostatic recurrence   "
112895|NCT01808209|"     Clinical Performance of Stenfilcon vs. Filcon II 3   "
112896|NCT01808196|"     The purpose of this research study is to test the safety of losartan potassium and see what     effects (good and bad) it has on you and your eosinophilic esophagitis.   "
112897|NCT01808183|"     The purpose of this study is to use a device to compare the blood flow in the patient's     injured arm to the patient's uninjured arm. This will help us determine 'normal' readings for     this device for a child's forearm and may in the future help us detect children that have     injured the blood vessels that go to the forearm when they have an elbow fracture. The     patient will be one of approximately 100 people involved in this research project at     Carolinas Medical Center, and the patient's participation will last until the patient is     discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the     readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is also     hypothesized that if the blood vessel of the injured arm is injured, the readings on the NIRS     device will be different than on the uninjured arm.   "
112898|NCT01808170|"     The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus     laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian     hormone and antral follicle count in patients with endometriomas.   "
113007|NCT01806753|"     Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal     dissection, the effects of sedation on ESD performance and complications have not been fully     evaluated. In the investigators previous retrospective study, en bloc resection and complete     resection rates, and procedure time could be improved by sedation with continuous propofol     infusion with opioid administration by anesthesiologists. However, there are several     limitations to the study including retrospective design. The investigators aimed to evaluate     the relationship among sedation methods, satisfaction of endoscopists or patients, clinical     outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.   "
112899|NCT01808157|"     This is a Phase II, multi-centre, randomised, double-blind, placebo-controlled study in male     and female subjects, aged ≥ 12 years with mild/moderate atopic dermatitis and at least     moderate pruritus. All subjects will receive BID topical applications of CT327 ointment or     vehicle for up to 4 weeks.      At baseline, the subjects must have atopic dermatitis, as defined by the Hanifin and Rajka     criteria, which involves a minimum of 5% and a maximum of 20% body surface area, an     Investigator Global Assessment Score of 2 or 3 (mild or moderate) and pruritus visual     analogue scale scores of ≥ 40mm (at least moderate).      All subjects will attend a screening visit not more than 21 days prior to Day 1. Subjects     will be required to return to the clinic on Days 1 (baseline visit), 4, 11, 18 and 29 (end of     treatment visit). All subjects will be asked to attend for a follow-up visit 14 (±3) days     after the last dose of study medication.   "
112900|NCT01808144|"     This study will assess the serum uric acid lowering effects and safety of lesinurad in     combination with febuxostat over a long-term timeframe.   "
112901|NCT01808131|"     This study will assess the serum uric acid lowering effects and safety of lesinurad in     combination with allopurinol over a long-term timeframe.   "
112902|NCT01808118|"     This is a Multicenter, randomized, double-blind study in subjects with moderate to severe     non-radiographic Axial Spondyloarthritis.      There is a 28-week open-label period followed by a 40-week double-blind, placebo-controlled     period for subjects who meet the randomization criteria. Subjects who flare during the     double-blind period will have an opportunity to receive at least 12-weeks of rescue therapy.   "
112903|NCT01808105|"     To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a     commercial infant formula and human breast milk.   "
112904|NCT01808092|"     The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to     Meropenem for treating hospitalized adults with nosocomial pneumonia including     ventilator-associated pneumonia   "
112905|NCT01808079|"     This clinical trial studies gene analysis in studying susceptibility to Wilms tumor. Finding     genetic markers for Wilms tumor may help identify patients who are at risk of relapse.   "
112906|NCT01808066|"     The purpose of this study is to examine the use of, and reaction to, one particular software     application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). The     hypothesis is that the use of these devices will increase engagement, motivation, interest,     and have perceived benefits to users with unique attention-limiting cognitive disabilities.     How does the observation of and user feedback from gameplay reveal areas of improvement for     the game, strengths, and perceptions of value among the players and adults?   "
112907|NCT01808053|"     To adapt and refine the BodyGuardian remote health monitoring system to acquire ECG, Heart     rate (HR), activity and breathing data, which will be integrated with weight, blood pressure     and symptom data, in subjects in an independent living center, with wireless transmission of     data to a central data analysis hub.   "
112908|NCT01808040|"     In this study the investigators want to find out about the effects of this drug in women with     metastatic breast cancer. The study has two major parts; dose escalation and dose expansion.     In the first part or dose escalation, subjects will be treated at the lowest dose effective     in men: 300 mg two times daily. Orteronel (TAK-700) will be increased to reach the highest     dose tolerated in men: 400 mg two times daily. This part of the study is designed to see if     female subjects can safely tolerate orteronel (TAK-700), and to measure the changes in     estrogens and androgens at different levels of TAK-700.      In the second part of the study (dose expansion), seven women will be treated with the dose     identified in the first part of the study as being safest and most effective. In this part of     the study, the investigators want to see if orteronel (TAK-700) will routinely and     significantly decrease the estrogen levels at the dose which will be used for any future     studies.   "
112909|NCT01808027|"     To investigate the causes of hospital variation in outcomes from acute coronary syndromes in     England and develop recommendations for improving patient care.   "
112910|NCT01808014|"     Posterior lumbar spinal surgical pain leads to a severe degree of pain, and, hence, various     means of pain management are required. Opioid pain medications such as morphine and fentanyl     are frequently used as intravenously administered medications. To reduce the use of opioids     for pain relief, a non-opioid form of pain relief, such as a Non-Steroidal Anti-Inflammatory     Drug (NSAID), is often added to the regimen.      With the use of NSAIDs, however, the risk of systemic side effects such as bleeding,     gastroduodenal bleeding, and kidney damage are being reported, and there is also a report of     inhibition of spinal fusion; these risks limit the use of NSAIDs.      Nefopam, a new centrally-acting analgesic agent, has been reported in an animal study to     desensitize post-surgical pain, and when used with an opioid analgesic, it indirectly     controlled the NMDA receptor, which inhibited the generation of c-fos gene at the spine.     There are also reports that Nefopam managed pain by inhibiting the serotonin reuptake     receptors.      In clinical practice, the administration of Nefopam in patients who required post-surgical     pain management reduced the use of opioid analgesics by 20-50 % and also reduced the     prevalence of nausea and vomiting.      Therefore, the investigators considered whether the addition of Nefopam for intravenous     patient-controlled analgesia in patients with lumbar spinal surgery would reduce the side     effects seen in monotherapy with opioid analgesia and result in effective pain management.     This study was conducted to address this question.   "
112911|NCT01808001|"     This study will determine if operating room teams manage a simulated event more effectively     using a critical event checklist. Performance will be evaluated using a score based on how     closely they follow a protocol for critical event management; a 'team' score and a score     based on clinical recovery of the simulated patient. All teams will receive a debriefing     session after managing 4 scenarios. Teams will return and manage 4 further scenarios after a     period of 6-9 months.      The investigators will be testing the hypothesis that both clinical and behavioral team     performance will improve with the use of Critical Event Checklists. The investigators also     expect that health professional (participant) could attain knowledge related to the     importance of non-technical skills and the use of CECs in the management of critical events.   "
113008|NCT01806740|"     Primary objective :      The main objective is to evaluate the value of DCE-MRI in prediction of response of patients     with HCC to treatment with Sorafenib assessed by mRECIST.   "
112912|NCT01807988|"     The main purpose of the study is to test whether Internet-based relapse prevention plus     medication has a better protective effect compared to medication only, for persons with     residual depressive symptoms who are currently in paid employment or in education. We     hypothesise that during the two years following the intervention:        -  The persons in the group receiving Internet-based relapse prevention plus medication          will be absent from work for fewer days due to sick-leave compared to those in the          medication-only group.        -  Fewer persons in the group receiving Internet-based relapse prevention + medication will          experience long term sick-leave (60 days or more) compared to those in the          medication-only group.        -  The persons in the group receiving Internet-based relapse prevention plus medication          will suffer fewer depressive relapses compared to those in the medication-only group.        -  At follow-up, the persons in the group receiving Internet-based relapse prevention plus          medication will have higher health related quality of life and lower levels of          depressive symptoms compared to those in the medication-only group.   "
112913|NCT01807975|"     A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis     obliterans syndrome in patients with pulmonary transplant (time difference in detecting     distal airways functional impairment by forced oscillation and the standard technique using     spirometry).   "
112914|NCT01807962|"     We hypothesize that local ultrasound guided injection with corticosteroid and local     anaesthetic are effective on the symptoms of GTPS.   "
112915|NCT01807949|"     The primary objective of the study was to evaluate the efficacy of lumacaftor in combination     with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)     who are homozygous for the F508del mutation on the CF transmembrane conductance regulator     (CFTR) gene.   "
112916|NCT01807936|"     Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with     radical lymphadenectomy remains the basic method of management of this malignancy. Lymph node     metastasis is one of the most important factors in predicting the prognosis of patients with     esophageal carcinoma, but the extent of lymph node dissection is still in debate, and there     is no statistical evidence based on large scale prospective randomized trials with regard to     the issue that which is the optimal extent of lymphadenectomy for esophageal cancer. The     purpose of this study is to test two different extents of lymphadenectomy     (Cervical-thoracic-upper abdominal three-field lymphadenectomy and Thoracic-upper abdominal     two -field lymphadenectomy) in middle or lower third intrathoracic esophageal cancer. This     research is being done to see whether one extent of lymphadenectomy is superior than the     other with better long-term outcome and acceptable postoperative short-term outcome or not.   "
112917|NCT01807923|"     The primary objective of the study was to evaluate the efficacy of lumacaftor in combination     with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)     who are homozygous for the F508del mutation on the CF transmembrane conductance regulator     (CFTR) gene.   "
112918|NCT01807910|"     The investigators overall hypothesis is that exacerbation of endoplasmic reticulum (ER)     stress in the liver is associated with significant alterations in phosphatidylcholines that     drive the NASH phenotype in obese humans. The investigators plan to examine this hypothesis     in a well-characterized cohort of obese subjects that are scheduled for bariatric surgery.     Methyl-D9-choline chloride will be infused before and after a 2-week high fructose or glucose     feeding to determine the biosynthesis and kinetics of secretory lipoprotein phospholipids. It     is proposed that phospholipid metabolism play an important role in the pathogenesis or     etiology of fatty liver in non-alcoholic conditions through mechanisms that invoke ER and     oxidative stress responses.   "
112919|NCT01807897|"     The purpose of this study is to compare three treatment modalities for central, or mixed     obstructive and central, sleep apnea in patients with chronic heart failure and reduced     ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and     continuous positive airway pressure (CPAP). The main outcome measures will be left     ventricular ejection fraction on echocardiogram and peak oxygen consumption on     cardiopulmonary exercise testing.   "
112920|NCT01807884|"     The purpose of this study is to evaluate the impact of an optimized suctioning procedure on     the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of     amylase enzymatic activity.   "
112921|NCT01807871|"     Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and     patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products     tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe     to continue NM upon a lapse and that doing so dramatically increases success at quitting. The     investigators will test this by doing a randomized trial in which all treatment and measures     are done from home with paper, phone or computer surveys. The investigators will recruit     smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks     of counseling. One group will be asked to stop use of the patch if they lapse and the other     group will be asked to continue use of the patch if they lapse. The investigators will     compare the groups on their success at quitting and side-effects.   "
112922|NCT01807858|"     Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus     Maternity and Children Training and Research Hospital, Department of Neonatology; be     randomized to very low birth weight premature infants began eating until you are discharged     from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium     lactis, the addition of chicory inulin, in the other group given placebo; Patients taking     weekly blood cultures, the presence of residues in both groups during feeding, to evaluate     the incidence of NEC and sepsis are planned. Randomization and the number of patients planned     to separate into groups.   "
112923|NCT01807845|"     Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to     UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system     etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link     proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more.     VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of melanoma.     Therefore there is an urgent need to enrich staple foods & beverages with VD, to prevent     deficiency.      A novel technology was developed , for nanoencapsulating VD within casein micelles (CM)     (natural milk protein nanoparticles). Previously we have found that the bioavailability of VD     in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a     synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk.      The main research question studied in the current project is: how will the bioavailability of     VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat free     milk product, like nonfat yogurt.      Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible,     may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less     than that in Tween 80, which is considered to be good. CM are particularly useful for     oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk     product is 0% fat yoghurt, chosen it for this study.      Methods: Yoghurts will be made from 3 milk formulations:        1. Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product,          in CM.        2. Skim milk with same dosage of VD, emulsified with Tween 80.        3. Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a          medical qualification examination, will be randomly assigned to 3 groups. Following          over-night fasting they will each consume a 150 gr yoghurt sample as detailed above, and          be requested to fast 2 more hours. Blood will be sampled before yoghurt consumption, and          after 1, 7 and 14 days following consumption. Blood-serum level of 25(OH)D (the form of          VD used as a status indicator in routine blood tests), by chemiluminescence immunoassay          (CMIA).      Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80,     in 0% fat yoghurt.      Significance of the study: With the widespread VD deficiency, decreased fat consumption and     rising demand for using only natural ingredients there is great importance in delivery of VD     and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of     using synthetic emulsifiers, and it is imperative to assure the bioavailability is not     compromised by this dramatic change.      CM solubilize VD and help uniformly distribute it in aqueous products and protect it against     heat, oxidation and UV.   "
112924|NCT01807832|"     The purpose of this study is to determine whether the capsaicin challenge can improve the     diagnosis, treatment, monitoring and follow-up in patients with chronic cough.   "
112925|NCT01807819|"     The purpose of this study is to determine if analysis of heart ultrasound images with new     software programs will provide better understanding as to the specific heart problems that     lead to symptoms of heart failure.   "
113362|NCT01802125|"     This clinical trial studies biomarker differences in samples from patients with     undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in     the laboratory may help doctors identify and learn more about biomarkers related to cancer   "
112926|NCT01807806|"     This project is a partnership between Soar Technology, the University of Southern California     (USC) Center for Innovation and Research on Veterans and Military Families (CIR) and the USC     Creative Media and Behavioral Health Center (CM&BHC) to conduct a Safety and Effectiveness     Study (SES) for an educational role-playing game developed by Soar Technology, Inc. The     purpose of the intervention to be delivered by Soar Technology is to educate families and     friends with the ultimate goal of empowering them to have a conversation with the     veteran/service member about readjustment issues. The study will assess the safety and     effectiveness of the provided game using personal interviews, play testing, and surveys. The     game playing experience is hypothesized to be safe and effective with respect to having     conversations with veterans/service members following deployment.   "
112927|NCT01807793|"     Stroke is the leading cause of disability, third leading cause of death, and one of the most     resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate nearly     double that of Euro-Americans (EA), and AA who experience a first-ever stroke are younger,     have greater stroke disability, more post-stroke complications, and slower recovery compared     to EA.   "
112928|NCT01807780|"     The purpose of this study is to determine if multiple vaccination in military personnel may     be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome,     autoimmune or lymphoproliferative disorders. At the same time, considering possible     interference between different vaccines, proteins and polysaccharides, living and     inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the     specific Human Leucocyte Antigens (HLA) genetic structure.   "
112929|NCT01807767|"     The objective of the study is to determine the efficacy and safety of Everolimus conversion     in liver transplantation. Most large US liver centers transplant patients with high Model for     End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant trials     in the US do not include patients with high MELD scores making it difficult to extrapolate     these trial data to the patients cared for at larger liver transplant centers. The greatest     potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the avoidance of the     side-effects of calcineurin-inhibitors, namely, renal insufficiency, diabetes and     hypertension. Therefore, this protocol is designed to study the efficacy and safety of     everolimus and Myfortic in liver transplant patients with high MELD scores at two large     centers with a vast experience in the administration of mTOR inhibitors.   "
112930|NCT01807754|"     This is a pilot, simulated breast cancer screening study. The goal of the study is to explore     these scanning modalities:      1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated     ultrasound(AUS)      2. Explore the utility of photoacoustic imaging as an adjunct to digital breast     tomosynthesis(DBT)/ultrasound(US)alone.   "
112931|NCT01807741|"     The purpose of this study is to compare asenapine with placebo in the treatment of depression     associated with bipolar disorder, type I over eight weeks.      We hypothesize that patients will show significantly greater improvement with asenapine than     placebo over eight weeks of treatment.   "
112932|NCT01807728|"     The objective of this study is to determine the effectiveness of different training programs     on outcomes in persons with spinal cord injury (SCI). We are interested to see which programs     have the greatest impact.   "
112933|NCT01807715|"     The investigators will conduct a voluntary anonymous survey at four separate Sacramento area     family planning clinics. The investigators will ask the staff at each facility to offer a     survey to all women 18 and older presenting to the clinic to have a first trimester (<12     weeks gestation) surgical abortion. Gestational age will be based on what the woman believes     is her gestational age at presentation, before any evaluation in the clinic. Women who cannot     understand or read the survey will be excluded. The investigators hope to implement the     survey at these clinics for 3-4 months reaching a minimum of 200 women (based on a target     population of 600 women receiving surgical first trimester abortions at these two clinics     over a 3-4 month period with a 95% confidence interval).   "
112934|NCT01807702|"     The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12     hours and then undergo a breath test, have blood drawn, and cells from the inside of the     mouth collected over a 12 hour period. The tests will be repeated at least a week later and     subjects receive a dose of dichloroacetate (DCA)   "
112935|NCT01807689|"     This is a multi-center clinical study to compare the performance of a collective panel of     salivary biomarkers to discriminate SS from non-SS in sicca cohorts recruited from three     clinical sites with the diagnostic outcomes based on the new classification criteria for     Sjögren's syndrome by the American College of Rheumatology (ACR) developed in 2012. This is     not a treatment study, but a pilot study to confirm diagnostic ability of a panel of salivary     biomarkers. All enrolled subjects must be classified as having both oral and ocular sicca     symptoms without another autoimmune/connective tissue disease (Appendix 2). At the University     of California in Los Angeles, using molecular techniques, we will quantify discriminatory     biomarkers in saliva collected from enrolled subjects, who are also being evaluated as part     of their clinical care using the standard diagnostic tests of the 2002 AECG criteria. We also     will test the performance of these biomarkers to predict the diagnosis of pSS according to     the AECG criteria, as these are the most widely used tests to diagnose pSS and assess disease     activity worldwide.   "
112936|NCT01807676|"     No prospective randomized clinical trial assessed the performance of this new device in a     clinical setting. Consequently the aim of this study is to determine clinical performance of     this new device compared with conventional DLT.        -  Trial with medical device   "
112937|NCT01807663|"     Determing optimal time of ventilator disconnection is a challenge for both acute and chronic     neuromuscular disease. In one case it is helpful for weanning from ventilator and in the     other to optimize daytime ventilation in the most severe patients. The investigators propose     to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular     patients in both acute and chronic conditions.   "
112938|NCT01807650|"     The main purpose of this phase III clinical trial is to show safety and efficacy of     Oleogel-S10 in the acceleration of Split-Thickness Skin Graft Donor Sites.   "
112939|NCT01807637|"     The purpose of this study is to determine if transcranial direct current stimulation     (tDCS)applied over the lower extremity motor cortex in conjunction with functional electrical     stimulation assisted gait training (FESAGT) is effective for improving gait in patients with     chronic stroke.   "
112941|NCT01807611|"     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched     related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a     haploidentical donor HCT with additional natural killer (NK) cells.      The investigators anticipate enrollment of 75 donors and 75 recipients.      PRIMARY OBJECTIVE:        -  To estimate the rate of successful engraftment at day +42 post-transplant in patients          who receive haploidentical donor stem cell plus NK cell transplantation with TLI based          conditioning regimen for high risk hematologic malignancy.      SECONDARY OBJECTIVES:        -  Estimate the incidence of malignant relapse, event-free survival, and overall survival          at one-year post-transplantation.        -  Estimate incidence and severity of acute and chronic (GVHD).        -  Estimate the rate of transplant related mortality (TRM) in the first 100 days after          transplantation.   "
112942|NCT01807598|"     This pilot clinical trial studies brentuximab vedotin in treating patients with advanced     systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab     vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to     grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them   "
112943|NCT01807585|"     This is a randomized control trial comparing VenaSeal Sapheon Closure System with     Radiofrequency Ablation.   "
112944|NCT01807572|"     Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular     disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder     disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United     States ). In the US, 65% of adults are overweight or obese. Unfortunately, the treatment of     choice for obesity (behavioral weight loss treatment) only results in a 10% reduction in body     weight on average and most patients regain this weight within a few years. Further, most     obesity prevention programs do not reduce risk for future weight gain. The limited success of     treatment and prevention interventions may be due to an incomplete understanding of the     processes that increase risk for obesity. Recent data suggest that obese adults show     abnormalities in reward from food intake and anticipated food intake relative to lean adults,     but the precise nature of these abnormalities is unclear and it has not been established     whether these abnormalities predate obesity onset or are a consequence. It is vital to     elucidate risk factors for obesity onset to advance understanding of etiological processes     and determine the content of prevention and treatment programs.      The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by     virtue of having two obese parents, show abnormalities in reward from food intake     (consummatory food reward) and anticipated reward from food intake (anticipatory food reward)     compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities     in consummatory and anticipatory food reward increase risk for weight gain and obesity onset,     (3) examine moderators that may amplify the relations of consummatory and anticipatory food     reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory     food reward in those participants who show obesity onset relative to those not showing     obesity onset. Each of these goals is described in more detail below.   "
112945|NCT01807559|"     The objective of this multi-site observational study is to further assess the long-term     patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing     benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi     Site Study (Protocol CLN006) for an additional 12 months.   "
112946|NCT01807546|"     The primary objective of this study is to determine if tumors in patients with papillomavirus     (HPV) positive or negative squamous cell carcinoma (SCC) that no longer responds to standard     therapy will decrease in size following treatment with the investigational drug, rigosertib     sodium (ON 01910.Na). A secondary objective is to determine if treatment with rigosertib     causes any side effects.      Rigosertib is an investigational drug, which means that it has not been approved by the U.S.     Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as a new     anticancer drug. Tests that we have done in the laboratory suggest that rigosertib works by     blocking cell division in cancer cells and causing them to die.   "
112947|NCT01807533|"     Four hypotheses will be tested in this study:        1. The intervention group performs better in child, parent and transactions outcomes than          the control group throughout the follow-up period.        2. The intervention group shows greater changes in early neurophysiological brain functions          and transactions within the family that lead to better neurodevelopmental outcomes than          the control group.        3. Certain polymorphisms of the dopamine-related genes are associated with the          neurodevelopmental outcomes in VLBW preterm infants.        4. Very low birth weight preterm infants carrying more genetic plasticity in the          dopamine-related genes may benefit more from the interventions than those carrying less          genetic plasticity.   "
112948|NCT01807520|"     To demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess     long-term efficacy, safety and tolerability of secukinumab.   "
112949|NCT01807507|"     Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a     gold standard   "
112950|NCT01807494|"     Hip replacement is a common surgical procedure performed to relieve the pain and disability.     In general, the surgery consists of replacing the diseased or damaged joint surfaces of the     hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons     may perform this operation in several different ways. The purpose of this study is to compare     two different methods of performing total hip replacement. The investigators hypothesize that     subjects treated with the anterior approached may show improved function during the early     postoperative period, but that no differences in pain or function will be present after the     first postoperative year.      In this study, patients that have elected to have hip replacement and consented to     participate in the study will be randomized to have his or her hip replaced using one of two     surgical techniques. Subjects will be randomized to be implanted using either an anterior or     posterior approach. With the anterior approach, the study surgeon will use an incision that     is on the front of the hip, and with the posterior approach, the incision will be more on the     backside of your hip. The study surgeon has done more than 300 total hip replacements with     both of these techniques.      A baseline assessment will be conducted before hip replacement surgery that includes x-rays,     functional tasks like getting up from a chair and stepping down a step, and three     questionnaires about the hip, the subject's general health, and how well the subject is able     to function. Also, subjects will be required to return to the clinic at several time points     after surgery for follow-up visits. Follow-up visits will include hip assessments and     questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3     months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These     follow-up visits are part of the study surgeon's normal routine for hip replacement patients,     and are not extra visits as a part of this study.   "
112951|NCT01807481|"     The primary objective of study is to evaluate the no of patients which maintain the Hb level     between 9.0 ~ 12.0 g/dl during the evaluation period   "
112952|NCT01807468|"     To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients     with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous     stem cell transplantation.      To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell     transplantation in patients with high-risk solid tumors who failed after tandem high-dose     chemotherapy and autologous stem cell transplantation.   "
112953|NCT01807455|"     The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital     Lidocaine when acne scars are treated   "
113363|NCT01802112|"     The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to     placebo, in reducing the colonic transit time in healthy subjects.   "
112956|NCT01807416|"     Aim of the present study will be to evaluate if the platform switching and the flat abutment     can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft     tissues will also be provided.      80 consecutively inserted dental implants will be included in this study. Maxillary and     mandibular implants will be considered, both in frontal and posterior area. After 6 to 12     weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented.     After 2 more months, the definitive porcelain crown will be delivered. The final outcomes     will be collected after 1 year from implant insertion.      Data will refer to the following timing:      T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3=     1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each,     with different implant/abutment design.      Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3     Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants +     GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays,     the mesial and distal Marginal Bone Level will be measured and compared among and between the     groups at the 4 different timing.      Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at     T0, T1, T2 and T3. Data will be statistically analyzed.   "
112957|NCT01807403|"     Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive     disorder. This electrical stimulation has been tested on, and shown to be effective at,     different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the     efficacies of each target have never been compared directly.      This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be     more efficacious.   "
112958|NCT01807390|"     This study will examine the perspectives of patients' undergoing surgery for lung or     esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions     regarding pain and surgical complications. This study will also assess a general health     related quality of life pre-op and post-op. Additionally, it will examine the importance of     receiving care close to home and their support system.      Hypotheses:        1. The data will allow investigators to better understand the willingness of patients to          participate in prospective, randomized studies comparing minimally invasive and open          thoracic surgery. Patients will not be willing to undergo randomization to an open          versus minimally invasive surgical procedure.        2. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and          documented as lesser than open surgery.        3. Patients may be willing to accept a higher risk of complications or more post-operative          pain if they were given the option to be cared for closer to their home.   "
112959|NCT01807377|"     This study is designed to assess the safety, tolerability and pharmacokinetics of multiple     oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight     and obese subjects.   "
112960|NCT01807364|"     Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal     hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in     particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on     the cardiovascular risk profile in adult CAH patients. The objective of this study was to     evaluate the cardiovascular risk profile of adult CAH patients.   "
112961|NCT01807351|"     Retrospective cohort of all the patients with elevated blood sugar (but no Diabetes)     attending the study sites from 2002 to 2007. We retrieval their records to see how many of     them actually developed diabetes. The patient's record will be followed up to 6 years after     their first abnormally high blood sugar checked. We will measure their parameters including     sex, age, pay code and whether they have hypertension or not to see what factors will     increase risk of DM development.   "
112962|NCT01807338|"     The purpose of this study is to document the long-term safety and tolerability after     intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who     participated in study sNN0031-001   "
112963|NCT01807325|"     The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may     be benign, precancerous, or cancer. Current tests such as cytology (looking under a     microscope) and tumor markers do not always give us the answer. The investigators are looking     for genetic markers on biopsy specimens from the pancreas that will give us a better test for     diagnosis. This study is only for diagnosing these lesions. The investigators are not     treating any patients.   "
112964|NCT01807312|"     It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and     abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy     even under sedation has been already assessed in some earlier trials. Air insufflation is     still the standard method, however, due a lack of suitable replacement of equipment or     technical improvement in colonoscopy.      The investigators use radio frequency identification (RFID) technology to record the number     of times and duration in the toilet of the patient after colonoscopy examination. These data     may be proxies for discomfort. With application of CO2 insufflation, the times and duration     in the toilet after examination will decrease as well as patient's discomfort after     procedure, and further improvement of patient compliance can be anticipated.   "
112965|NCT01807299|"     The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause     disabilities through whole life. The treatment of this disease is expensive and difficult.     Moreover, physical exercise and omegas consumption may improve the cognitive functions and     behavior, so it could be an interesting strategy to improve this disorder. The aim of the     present study is to verify the effects of multiple components physical training and the     consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and     IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be     selected. The volunteers will be randomly divided into four groups: Physical Training Group     (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The     protocol of the experiment will last three months in which the OPTG will make physical     training and receive fish oil capsules, and the PTG will make only the physical training and     receive a placebo of fish oil. The others groups will be oriented not to make any type of     physical training, but the OG will receive fish oil capsule, and the CG will receive a     placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will     be made at the beginning and at the end of the protocol.   "
112966|NCT01807286|"     The goal of this clinical research study is to find the highest tolerable dose of     pomalidomide that can be given in combination with melphalan and dexamethasone that can be     given to patients with AL amyloidosis. The safety of this drug combination will also be     studied.      Pomalidomide is designed to change the body's immune system. It may also interfere with the     development of tiny blood vessels that help support tumor growth. This may decrease the     growth of cancer cells.      Melphalan is designed to damage the DNA (genetic material) of cells, which may cause cancer     cells to die.      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.     Dexamethasone is often given to Multiple Myeloma (MM) patients in combination with other     chemotherapy to treat cancer.      Planned Phase I/II Study terminated early during Phase I portion without continuation to     Phase II.   "
112967|NCT01807273|"     Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis   "
112968|NCT01807260|"     To evaluate and compare the results of conventional and stepwise shock wave lithotripsy     treatment modalities in pediatric urinary lithiasis.   "
112969|NCT01807247|"     The aim of the study is to evaluate the short effects of a two rehabilitation session     commonly performed in physical therapy,        1. muscle strengthening of the lower limbs and        2. effort reconditioning with cyclo ergometer, on gait characteristics (kinematics,          kinetics and electromyographic) in patients with central nervous system lesion.   "
112970|NCT01807234|"     The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan     nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for     migraine associated symptoms including nausea and allodynia.   "
112971|NCT01807221|"     To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it is     safe and can help the well-being of patients with worsening chronic heart failure and either     type II diabetes with or without chronic kidney disease or kidney disease alone. These     treatment doses will be compared to eplerenone, another marketed drug approved to treat heart     failure.   "
112972|NCT01807208|"     The goals of this study are two fold: 1) To learn whether a personalized patient health goal     and reminder tool helps patients to learn more about their condition and to make changes in     behavior and medication taking to reduce the risk of another heart attack. 2) To examine a     blood sample to learn how patients are responding to their medications. The study team will     enroll approximately 220 patients in the hospital recovering from a heart attack. Half of the     patients will receive the educational tools and a copy will be sent to their outpatient     provider.   "
112973|NCT01807195|"     Generally, a contrast medium is used when performing a CT scan or radiographic tests such as     angiography because it heightens image clarity and can increase diagnosis accuracy. Despite     these advantages, contrast media can cause allergic reactions in the body or a decline in     renal function. Therefore, they should be handled carefully and explained sufficiently to the     patient. For intensive care patients, the use of contrast agents has been revealed as a major     cause of acute renal damage, and many studies have investigated this complication by     examining incidence rates and prevention strategies. Hypothesis: Among intensive care     patients, the group in which a contrast medium was used will have a higher risk of renal     function decline compared with the group in which a contrast medium was not used, and, hence,     the use of contrast media becomes a cause of renal function deterioration. Categorizing     patients with renal function decline according to the new RIFLE criteria can have an     association with the prognosis of intensive care patients, such as hospitalization period and     death rate, which can promote faster intervention.   "
112974|NCT01807182|"     This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination     chemotherapy works in treating patients with melanoma that has spread to other places in the     body. Biological therapies, such as TIL, may stimulate the immune system in different ways     and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and     fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     TIL after combination chemotherapy may kill more tumor cells.   "
112975|NCT01807169|"     The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with     prevalence of patients on this type of therapy steadily increasing. The benefit / risk     balance to stop or continue the APA for the digestive endoscopic procedure confronts us every     day in clinical practice to another: the relationship thrombosis / hemorrhage.      Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from     the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin     for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic     mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The     concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned     gradually to the usual practice. However, these procedures are still not allowed under     clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the     literature.      It is necessary to achieve a large national multicenter study, to clarify the risk of post     recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in     combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures     used in daily practice by endoscopists in expert centers (clip, ligature and loop devices,     preventive adrenalin injection).      The aim of the MEDOC study is to determine the incidence of immediate and delayed bleeding     after colonic polypectomy and / or EMR for patients on clopidogrel.      It is expected in this work an incidence of post-polypectomy bleeding close to that observed     during the implementation of these actions in the population without any anti platelet     agents.   "
112976|NCT01807156|"     The purpose of this study is to learn about the effect of the investigational agent tivozanib     on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also     plan to collect information on the likelihood to develop side effects while on this     treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is     designed to stop the tumor from developing new blood vessels.   "
112977|NCT01807143|"     This clinical trial studies genetic biomarkers in tissue samples from patients with     osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer   "
112978|NCT01807130|"     Purpose and Objective: Heart failure therapies including beta-blockers, ACE-inhibitors,     aldosterone antagonists, implantable cardioverter-defibrillator (ICD) and cardiac     resynchronization therapy (CRT) devices have proven beneficial but are underused in eligible     patients. The investigators seek to determine if automating referral to cardiologists and     electrophysiologists through an intelligent electronic medical record system can improve     adherence to American College of Cardiology (ACC)/ American Heart Association (AHA) heart     failure guideline recommended therapies.      Study activities and population group: The AMERICA-HF trial will be a randomized,     single-center, single blinded study comparing standard-practice provider initiated     cardiovascular specialty referral to experimental automated medical record driven     cardiovascular specialty referral. An investigational program will automatically screen all     finalized electronic reports from clinically indicated transthoracic echocardiogram studies     performed in the Duke University Echo Lab system and create an automated query to obtain HF     ICD-9 codes. Eligible patients will be randomly assigned to participate in a registry (n=125)     or automated electronic medical record (EMR) based subspecialty care intervention arm     (n=125).      Data analysis: The primary endpoint is rate of adherence (%) to ACC/AHA HF guideline     recommended therapies at 3, 6, and 12 month follow-up among patients randomized to the     registry compared to the intervention. Differences in characteristics (including use of     guideline recommended therapies) will be tested using Pearson Chi-square tests for     categorical variables and Wilcoxon two-sample tests for continuous variables. Time to event     analysis will be performed for the secondary endpoints of hospitalization or death.   "
112979|NCT01807117|"     This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance     imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon     and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and     diagnose rectal cancer or recurrence of colorectal cancer   "
112980|NCT01807104|"     The purpose of this study is to compare the short term effectiveness and return to function     of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on     the front part of the hip joint) versus Posterior Approach (incision over back part of the     hip joint).   "
112981|NCT01807091|"     This pilot clinical trial studies the feasibility of having induction chemotherapy in an     outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome     (MDS), at least 18 years of age will be examined. Treating eligible patients with induction     chemotherapy in an outpatient setting may save in healthcare cost and improve a patients'     quality of life.   "
112982|NCT01807078|"     Treatment with statins has a class I indication after percutaneous coronary intervention     (PCI), but is often discontinued by patients due to side effects.      Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals     (i.e. compounds derived from foods with cholesterol lowering actions).      It remains unknown, however, which of these two therapeutic approaches is more effective     after PCI.      The primary objective of this study is to compare the efficacy and tolerability of ezetimibe     vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous     coronary intervention.   "
112983|NCT01807065|"     This randomized phase II trial studies how well giving sipuleucel-T with or without radiation     therapy works in treating patients with hormone-resistant metastatic prostate cancer.     Vaccines may help the body build an effective immune response to kill tumor cells. Radiation     therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving     sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate     cancer   "
112984|NCT01807052|"     This trial studies biomarker expression in tissue samples from patients with bone sarcomas.     Studying biomarker in tissue samples from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer   "
112985|NCT01807039|"     Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses     undergoing surgery. It affect most seniors and accompanied by a series of complications. The     aim of our retrospective clinical trial is to establish a thirty-day mortality rate after     surgical solutions, mortality during hospitalization and compare the types of anesthesia     chosen during the performance (general vs. subarachnoid anesthesia).   "
112986|NCT01807026|"     This study is being done for the following reasons:      To determine the safety of LY2886721 and any side effects that may be associated with it and     to see how much of the study drug is in the blood and the cerebrospinal fluid when one dose     is given to healthy participants and participants diagnosed with Alzheimer's disease. It will     also look at how safe and tolerable the study drug is when given to healthy participants in     higher doses.      This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B     or C.      Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll     healthy participants.      For Group A or B, participation in this research study could last up to 34 days. For Group C,     participation could last up to 60 days.   "
112987|NCT01807013|"     Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and     mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.   "
112988|NCT01807000|"     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,     pharmacokinetics, safety and tolerability following a single oral administration of [14C]     Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose     of this study is to investigate how and how quickly Prucalopride Succinate or its break down     products are excreted by analysing blood, faeces and urine samples collected during the     study.   "
112989|NCT01806987|"     The purpose of this project to determine whether the KITS Program, an intervention to improve     early literacy, prosocial and emotion and behavior regulation domains of school readiness,     improves school readiness and school outcomes in children from socioeconomically     disadvantaged neighborhoods.   "
113021|NCT01806571|"     This phase II trial studies how well daunorubicin hydrochloride, cytarabine, and nilotinib     work in treating patients newly diagnosed with acute myeloid leukemia. Drugs used in     chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Nilotinib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Giving daunorubicin hydrochloride with cytarabine     and nilotinib may kill more cancer cells.   "
112990|NCT01806974|"     Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many     pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6,     Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid     arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti     CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk     of infection, both viral and bacterial.      These new biotherapies could have an impact on periodontal status        -  either by favouring sub gingival colonization of root surfaces by periodontal pathogenic          bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,        -  or a positive modulation of the host response by inhibiting bone resorption of the          alveolar process.      To date, very few studies have been conducted on this subject which is really a translational     research, involving several medical specialties.   "
112991|NCT01806961|"     Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete     clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of     follow-up.   "
112992|NCT01806948|"     We randomized patients who received laparoscopic surgery for benign gynecologic disease into     double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared     the degree of postoperative nausea and vomiting in experimental and control groups.   "
112993|NCT01806935|"     The purpose of the study is to assess the the effect of the study product on itching symptoms     associated with xerotic dermatitis in aged population   "
112994|NCT01806922|"     Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients     who received a combination of yoga and traditional physiotherapy were getting more     improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga     can improve post-stroke depression symtom.   "
112995|NCT01806909|"     Background:        -  Adenoviruses are viruses that typically cause symptoms of a cold or eye infection. These          viruses are being tested as part of a possible new vaccine. Researchers hope that the          adenovirus will help carry the vaccine into the body and cause an immune response. An          immune response is the body s release of cells and substances that protect the body from          infection. If an adenovirus vaccine can be developed, it might be used as part of a          vaccine for malaria or other serious illnesses. Researchers want to test the adenovirus          vaccine as a nasal spray in healthy volunteers. The vaccine is called AD4-H5-VTN.        -  Because the vaccine contains a live adenovirus, there is a possibility that participants          can infect other people. Therefore, participants' intimate contacts must join this          study. An intimate contact is someone who the participant will kiss on the mouth or have          sexual intercourse with during the period of this study.      Objectives:        -  To study the immune response of the AD4-H5-VTN vaccine in healthy volunteers.        -  To see if the adenovirus in the AD4-H5-VTN vaccine is contagious or spreads to others.      Eligibility:        -  Healthy volunteers between 18 and 49 years of age.        -  Intimate contacts of healthy volunteers between 18 and 65 years of age.        -  Participants must not have evidence of previous exposure to adenovirus type 4.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants who will receive the vaccine must be willing to be hospitalized for between          5 and 7 days. They will come to the National Institutes of Health for follow-up visits          weekly for the first month, after 8 weeks, in 6 months, and possibly 1 year. They must          also avoid all vaccines (including seasonal flu vaccine) and allergy shots for 30 days          before and after having the study vaccine.        -  Participants will enter the hospital for the vaccine study visit. They will receive the          vaccine as a nasal spray. Because the vaccine uses a live virus, participants may be          contagious for the virus for up to 4 weeks. They will remain in the hospital in          respiratory isolation for 7 days, or until they have two negative nasal washes taken 1          day apart. A negative nasal wash means that there is no live virus in the nose.        -  After leaving the hospital, participants will keep a diary at home for at least 3 weeks.          They will record their temperature, any symptoms, or other health changes every day          during this time.        -  Participants should avoid intimate contact with others for 28 days after having the          vaccine. Intimate contact includes kissing on the mouth and sexual intercourse. Also,          participants should not share kitchen utensils, drinking cups, towels, or hair combs          with others. Intimate contacts will also keep track of any illnesses or symptoms they          develop during this time.        -  At the follow-up visits, participants will provide blood and swab samples for study.   "
112996|NCT01806896|"     This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920     in Subjects with Early Huntington's Disease.   "
112997|NCT01806883|"     The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb     movement in chronic stroke patients following rehabilitation using the Nintendo Wii. The     investigators hypothesize that patients will increase their use of compensatory strategies     following this rehabilitation.   "
112998|NCT01806870|"     The purpose of this study is to see if taking two nutritional supplements, zinc and SAMe     (S-adenosylmethionine), can improve lung health and immune function in persons with HIV. You     are being asked to volunteer because you have HIV (Human Immunodeficiency Virus) and you take     anti-retroviral therapy (ART) medications.   "
112999|NCT01806857|"     The purpose of this study is to determine whether Nuedexta is effective in the treatment of     symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral     Sclerosis (ALS).   "
113000|NCT01806844|"     Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation     in a non-invasive manner. Through the use of near infrared light, the difference between     oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a     numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no     cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital     cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show     the prognostic value of NIRS as extra monitoring.   "
113001|NCT01806831|"     The laser areas treated with biocellulose sheet from coconut juice containing     anti-hyperpigmentation agent (biocellulose mask, Farhorm®) heal faster than vaseline     ointment which is a standard treatment.   "
113002|NCT01806818|"     Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen     in Acute Low Back Pain Patients during 7 days.   "
113003|NCT01806805|"     Myoclonus Dystonia is a disease in which myoclonus distort the precision of movements and so     cause a handicap in the movements of the everyday life. Response to oral medications may be     incomplete and surgery may cause operating risk.      Zonisamide is an antiepileptic drug which could bring a therapeutic profit in Myoclonus     Dystonia on the severity of the myoclonus.   "
113004|NCT01806792|"     The purpose of this study is to evaluate the efficacy and the safety of Risedronate,     cholecalciferol combination tablet in patients with Osteoporosis   "
113005|NCT01806779|"     Previous results from the investigators' Center have shown that combination treatment with     Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to     replicate these findings with this study.   "
113006|NCT01806766|"     The purpose of this prospective, randomized study was to compare the clinical and     radiographic results and the prevalence of osteolysis of the cementless total hip     arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked     polyethylene bearings on the other side in the young and active patients.   "
113009|NCT01806727|"     This study is evaluating two approaches to improving the control blood sugar, and other risk     factors for heart disease in overweight and obese adults with type 2 diabetes. The first     approach has participants focus on weight loss via reducing food intake and increasing     physical activity, while attending weekly group sessions led by trained community health     workers for 12 months. The second approach has participants receive education on diabetes     self management, which focuses primarily on glucose control, while attending monthly group     sessions led by a study staff member for 12 months. We are recruiting persons with type 2     diabetes who live in the Winston-Salem/Forsyth County area of North Carolina who are willing     to attend sessions at the Downtown Health Plaza of Wake Forest Baptist Health. We will     measure risk factors for heart disease (glucose control, blood pressure, blood cholesterol)     and calculate the predicted risk of heart disease, and see which intervention lowers risk to     a greater extent at 12 months, as well as 24 months.   "
113010|NCT01806714|"     The purpose of the study is to evaluate the effectiveness of a managed care-based HPV     vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse     practices and patient populations. The trial will measure the effectiveness of text messaging     reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine     series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive     visits for adolescents      The hypotheses are that text-messaged reminders to parents of adolescents will result in     improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease     the intervals between vaccine doses and will improve rates of preventive care among     adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV     vaccination, well child care visits) for which their adolescent is due will be compared to a     control group of parents receiving general health tips through text messages.   "
113011|NCT01806701|"     This study will examine how brain activation changes as a result of behavioral treatment for     posttraumatic stress disorder (PTSD) in adolescents. The investigators will conduct     functional magnetic resonance imaging (fMRI) scans before and after the widely-used     trauma-focused cognitive behavioral therapy to better understand how the brain recovers from     illness. This study will provide much needed information about brain abnormalities in abused     youth, and could lead to improvements in behavioral treatments for patients who do not     respond to current treatments.   "
113012|NCT01806688|"     This clinical trial is being conducted to study whether eating certain snacks will reduce     your desire to eat and for a longer period of time compared to other snacks. The     investigators are testing 2 different snacks. Study #1 will involve eating 2 different     seed-like snacks or water. Study #2 will involve eating pita bread with jam, bread with jam     or water. The test snack is higher in protein and/or fibre compared to the reference product.   "
113013|NCT01806675|"     The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer     patients. We will assess the uptake of this novel radiopharmaceutical in subjects with breast     cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiring     antiangiogenesis treatment.   "
113014|NCT01806662|"     Atopic dermatitis (AD) is a chronic disease associated with intense itching, which affects     most aspects of everyday life in the majority of patients. Acute inflammation and     extensor/facial involvement is common in infants, whereas chronic inflammation increases in     prevalence with age, as do localization to flexures. AD has a complex background     characterized by immune activation, increased epidermal thickness in chronic diseased skin,     and defective barrier function. In normal, healthy skin, the outer layer of the epidermis,     the stratum corneum is made up flattened dead cells called corneocytes held together by a     mixture of lipids and proteins. The stratum corneum and, in particular, the lipid layer are     vital in providing a natural barrier function that locks water inside the skin and keeps     allergens and irritants out. In people with AD, the barrier function is defective, which     leads to dry skin. As the skin dries out, it cracks allowing allergens and irritants to     penetrate.      Mild AD can be controlled with emollients and topical medications. However, moderate to     severe AD is extremely difficult to control and requires systemic treatment that is often     unsatisfactory due to impracticality and lack of effectiveness. Only three therapeutic     options exist for moderate to severe AD, including: 1) oral steroids 2) cyclosporine A (CsA),     that is not widely used in the US as it is not FDA approved for AD and 3) ultraviolet     phototherapy. Oral steroids and CsA treatments have major side effects and UV radiation     therapy is highly inconvenient for patients. Several biologic medications, such as TNF-alpha     inhibitors, are effective, convenient, and relatively safe therapies for psoriasis, but have     thus far not shown efficacy in AD. Ustekinumab is a unique biologic medication that may     specifically target AD.      The investigators study will determine whether there is a reversal of the skin thickness and     the immune pathways involved in the disease during treatment with Ustekinumab and what     specific immune cells are involved. The investigators are also interested to understand how     the clinical reversal of the disease will correlate with tissue reversal of the disease.   "
113015|NCT01806649|"     There is a need for more effective therapy for patients with esophageal squamous cell     carcinoma who developed disease progression after first line therapy. Currently, there is no     standard second-line therapy for this disease.      BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials. In a cellular model of     oral-esophageal carcinogenesis, it has shown that EGFR overexpression activated PI3/AKT     pathway. Therfore, there is interest to see the efficacy and safety of BKM120 in this     setting.   "
113016|NCT01806636|"     This registry is a post market observational, prospective, multi-center registry. It is     designed to evaluate patient experience with the RePneu™ device for the relief of the     emphysema symptoms and the continued collection of safety and effectiveness data on this CE     Mark product. In addition, the registry will collect information that will serve as the     foundation for a cost effectiveness analysis.   "
113017|NCT01806623|"     As for the indication of vulvovaginal candidiasis, a single oral administration of     fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in     Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and     topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose     of this trial is to confirm the efficacy and safety of single oral administration of     fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.   "
113018|NCT01806610|"     The purpose of the study is to evaluate the safety, tolerability, and PK following a single     administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on     hemodialysis.   "
113019|NCT01806597|"     Purpose of the study is to demonstrate the efficacy of secukinumab versus placebo on     palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of     secukinumab.   "
113022|NCT01806558|"     A combined molecular breast imaging / ultrasound system will enable coregistration of a     functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding     anatomical abnormality seen on ultrasound.   "
113023|NCT01806545|"     A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard     practice treatment in improving the rate of AVF maturation and use in subjects with end-stage     renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.      It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin     matrix containing endothelial cells can provide a continuous supply of multiple growth     regulatory compounds to the underlying cells within the blood vessel, while being protected     from the effects of blood flow in the vessel(s) or complications resulting from being in     direct contact with the point of injury.   "
113024|NCT01806532|"     The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and     septic lung with positron emission tomography (PET) imaging and to examine the distribution     of inflammation, as measured by neutrophil metabolic activity.   "
113025|NCT01806519|"     Neck pain is a common problem in the western world. There is a group of people suffering from     neck pain with a reduced ability to maintain an upright posture showing a forward head     position and an altered muscle function.      The aim of the study was to evaluate a motor control intervention for patients with     persistent neck pain and a forward head posture.      This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and     multiple baselines.      The tailored motor control intervention addressed the faulty postural alignment and the deep     muscles of the cervical spine.   "
113026|NCT01806506|"     Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric     bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic     sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to     compare outcomes of these two surgical methods in terms of weight loss, improvement of common     comorbidities of obesity and influence on metabolic and hormonal status.   "
113027|NCT01806493|"     The prevalence of individuals who are classified as overweight or obese is increasing all     over the world and it represents a primary health concern due to the relationship between     obesity and a number of diseases, disabilities, comorbidities, and mortality. The definition     of obesity should consider not only the increase of body weight but more precisely the     increase in body fat mass. However, body composition evaluation is rarely performed in     overweight and obese subjects and the diagnosis is almost always achieved just considering     body mass index (BMI). In fact, whereas BMI can be considered an important tool in     epidemiological surveys, different papers stated the limitations of the use of BMI in single     individuals.      Aim: to assess the determinants of body composition in a population of overweight and obese     subjects and to propose a different model of estimation of fat mass (FM) in these subjects     when more reliable equipments for the evaluation of body composition are not available.      Methods: in 103 overweight or obese subjects ( 74 women, aged 41.5±10 years, and 29 men, aged     43.8±8 years); a multidimensional evaluation was performed including the assessment of body     composition using Dual Energy X-Ray Absorptiometry (DXA), anthropometry, bioimpedance     analysis (BIA) and biochemical parameters (total cholesterol, triacylglycerol, HDL- and LDL-     cholesterol, free fatty acids and glycerol, glucose, insulin, C-reactive protein, plasma     acylated and unacetylated ghrelin, adiponectin and leptin serum levels).   "
113028|NCT01806480|"     Although breast milk has numerous benefits for infants' development, with heightened effects     in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter     breastfeeding duration than mothers of term infants. One of the explanations proposed is the     difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home     environment. A person-centred proactive telephone support to breastfeeding mothers after     discharge from NICU is expected to promote mothers' sense of trust in their own capacity and     thereby facilitate breastfeeding. We hypothesize that proactive (health service initiated)     telephone breastfeeding support offered to mothers of preterm infants after hospital     discharge is more effective than reactive (mother initiated, and defined as usual care)     telephone support at increasing the proportion of mothers who are exclusively breastfeeding 8     weeks after discharge.      A multicentre randomized controlled blinded trial has been designed to evaluate the     effectiveness and cost-effectiveness of person-centred proactive telephone support on     breastfeeding to mothers of preterm infants. Mothers will be informed about the study before     discharge. Participating mothers will be randomized to either a control group or intervention     group, immediately after discharge. Mothers will be notified to what group they have been     randomized to through phone call or sms, depending on mother's preferences.        -  Control group: person-centred reactive telephone support where mothers can phone the          breastfeeding support team up to day 14 after hospital discharge.        -  Intervention group: reactive support AND person-centred proactive telephone support in          which the breastfeeding support team phones the mother daily for up to 14 days after          hospital discharge.      A stratified block randomization will be used; group allocation will be done on high or low     SES (i.e. educational level) and by NICU. Recruitment will be performed continuously until     1116 mothers (I: 558 C: 558) have been included. The data will be collected at eight weeks     after discharge and at six months of infant's postnatal age using telephone interviews and     questionnaires. Primary outcome is exclusive breastfeeding at eight weeks after discharge     from the NICU. Secondary outcomes are breastfeeding (i.e. exclusive, partial, none and     method), mothers satisfaction with breastfeeding, attachment, stress and quality of life in     mothers/partners at eight weeks after hospital discharge and at six months postnatal age. A     qualitative evaluation of experiences of providing/receiving the intervention will also be     performed with mothers and staff respectively.   "
113029|NCT01806467|"     Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them     the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the     agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous     pulmonary ThD in measuring CO in hemodynamically unstable patients.   "
113030|NCT01806454|"     the purpose of this study is to determine whether calcium supplementation is effective to     prevent preeclampsia in Sichuang Province of china and which dose is more suitable   "
113031|NCT01806441|"     Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several     lines of evidence suggest that this effect is associated with changes in the regulation of     different genes at the intestine level involved in the cholesterol and fatty acid metabolism     pathways. The present study will examine the impact of a short-term high fat diet versus a     short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine     triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer     protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a     critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid     absorption. Gene expression studies will be performed on duodenal biopsies. The primary     hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger     ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a     short-term low fat diet.   "
113032|NCT01806428|"     Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy improves     the microcirculation of severe septic patients.      Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients:     Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of     the onset of sepsis were included in a one year period.      Interventions: Patients who had no contraindication to aPC administration received aPC at a     dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were     considered as controls.   "
113035|NCT01806389|"     Goals: The overarching goals for this proposed research are to provide pilot data for a study     to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine     maintenance and to develop guidelines for the practitioner treating buprenorphine maintained     women who wish to breastfeed.      Background: There is an increase in the prevalence of illicit opiate use among women of     childbearing age. Recently, a large multisite study has suggested buprenorphine as an     alternative to methadone for use in this population. As a consequence, buprenorphine is     likely to be delivered to larger populations of pregnant and post-partum women. The     population of prenatally opioid-exposed neonates is a particularly vulnerable population.     Advances in neuroscience, molecular biology and epigenetics indicate that greater attention     should be given to strategies that prevent, reduce, or mitigate the consequences of     significant adversity on the developing brain. Breast milk and breastfeeding offer     significant health and other benefits that are particularly salient for this group. Today,     there is a near complete lack of information regarding the safety of buprenorphine     maintenance and lactation, making it unlikely that providers will endorse or mothers will     adopt this practice.      Methods: Five pregnant buprenorphine maintained breastfeeding women and their neonates will     be enrolled. Subjects will selected by buprenorphine maintenance in the postpartum period and     enrollment in a parent protocol and by decision to breast feed their infants. Subject will     provide breast milk at times of peak maternal buprenorphine levels on days 2, 3, 4, 14 and 30     after delivery to determine buprenorphine and norbuprenorphine concentrations. Subjects will     also provide plasma at times of peak buprenorphine levels for determination of buprenorphine     and norbuprenorphine concentrations on the same days. Concentrations of buprenorphine and     norbuprenorphine in the plasma of infants will be determined on approximately day 14 of life.     The relationship between maternal dose, maternal and infant plasma concentrations, and breast     milk concentrations of buprenorphine and norbuprenorphine will be determined, and ingestible     infant dose calculated.   "
113036|NCT01806376|"     1. purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib          Maleate capsules and rational dosage regimen for phase Ⅱ study        2. Experimental Design： A phase Ⅰ study of single-center        3. Test drug: Subutinib Maleate capsules        4. Sample size≥20   "
113037|NCT01806363|"     Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan     and chlorthalidone.   "
113038|NCT01806350|"     This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary     incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control     symptoms and improve physical function and quality of life in gynecologic cancer survivors.   "
113039|NCT01806337|"     Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus     PEG-Filgrastim Followed by Alemtuzumab Consolidation   "
113040|NCT01806324|"     The objective of this study is:      To evaluate the pharmacokinetics and safety of an experimental combination tablet containing     20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to     healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and     50 mg losartan potassium tablets.   "
113041|NCT01806311|"     Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of     amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in     healthy male volunteers.   "
113042|NCT01806298|"     This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity     of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency (AGHD),     who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD which was     stopped at least 1 month prior to Screening and have no contraindication to the use of GH.   "
113043|NCT01806285|"     The purpose of this sample collection study is to prospectively collect respiratory viral     clinical samples, conduct standard of care comparator testing and archive the collected     residual samples for future testing in order to establish the clinical performance     characteristics of the investigational instrument.   "
113044|NCT01806272|"     This is a open,randomized phase II trial comparing effectiveness and safety of local use of     rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral     mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II     and less oral mucositis at the end of treatment.The hypothesis of the study is that the local     use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more     oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.   "
113045|NCT01806259|"     Do the use of Ketorolac in one intravenous injection at the moment of the operative incision     reduce the number of recurrence in patient with advanced breast cancer without inflammation     signs.   "
113046|NCT01806246|"     The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue     Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation     reflecting the current knowledge about the disease, Heart Rate Variability Coherence     Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy.     The study is designed as a Single-Case study including 10- 15 participants.   "
113047|NCT01806233|"     There will be successive changes in traditional Chinese medicine rehabilitation for stroke     patients with limb hemiparetic through therapy of acupuncture and moxibustion.   "
113048|NCT01806220|"     -  Saliva plays an important role in the homeostasis of the digestive tract mucosa.        -  Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in          defficient concentrations in patients with gastroesophageal reflux disease (GERD) and          reflux related laryngitis (LPR).        -  The epidermal growth factor receptor (EGFR) signaling pathway is one of the most          important pathways that regulate growth, survival, proliferation, and differentiation in          mammalian cells        -  Eperdermal growth factor receptor (EGFR) overexpression has been linked to          hyperproliferative diseases.        -  It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR          expression.        -  The objective of the current study was to try to establish a correlation between the          expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis          in adults with GERD and LPR   "
113049|NCT01806207|"     This was a study that compared Durolane injections to saline injections in the treatment of     unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two     treatments unaware of which treatment they received. The study was conducted at 13 centers in     Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study     treatment.   "
113050|NCT01806194|"     The EMPOWER diabetes program is a year-long, community-based program designed to enhance     diabetes management in rural African American women with uncontrolled diabetes. The treatment     is delivered by community peers and follows a relative Small Changes approach.   "
113326|NCT01802593|"     The goal of the present study is to evaluate the best regimen for infliximab monotherapy, and     to evaluate if limited combination therapy with IFX and an Immunomodulator for the first 6     months of therapy, in prior Immunomodulator failures, is superior to monotherapy with     Immunomodulator cessation from the second infusion, in preventing loss of remission to IFX.   "
113051|NCT01806181|"     This study will offer a supervised exercise program and healthy eating education to women     with breast cancer undergoing chemotherapy as a physician-referred program and measure the     adoption, adherence and satisfaction with the intervention as well as its health effects.     Past trials have demonstrated various health benefits of exercise yet it is not currently     part of supportive care and few suitable programs exist in the community or outside of     research. This study is expected to address the unique barriers related to exercise in breast     cancer survivors and to better understand how the intervention might work in a real life     setting.   "
113052|NCT01806168|"     The purpose of this study is to assess the effects of repetitive transcranial magnetic     stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress     disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or     high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an     effect on symptoms of PTSD compared to sham rTMS treatment.   "
113053|NCT01806155|"     Headache after major craniotomy may be a problem in taking care of the patients. The     investigators want to identify the incidence of headache after major craniotomy and also the     risk factors.   "
113054|NCT01806142|"     Several lines of evidence indicate that a significant proportion of cardiovascular disease     (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and     perturbations, defined as the metabolic syndrome. It has been estimated that approximately     25% of the North American adult population is living with the metabolic syndrome. Recent     studies from the investigators group show that overaccumulation of atherogenic     triglyceride-rich lipoproteins (TRL) seen in insulin-resistant patients is partly due to     increased production rate of intestinally derived apolipoprotein (apo) B-48-containing     lipoproteins. This is of interest because substantial evidence exists indicating that     elevated levels of intestinal lipoproteins are associated with increased CVD risk. In this     regard, there is some evidence that medium-chain triglycerides (MCTs) may beneficially modify     lipoprotein metabolism in hypertriglyceridemic patients. However, as emphasized in the body     of this grant proposal, the specific impact of MCTs on the intestinal lipoprotein secretion     and on expression of genes that regulate intestinal lipid absorption and chylomicron     synthesis has not yet been investigated in humans.      The general objective of the proposed research is to investigate the mechanisms by which MCTs     beneficially modify intestinal lipoprotein metabolism in patients with the metabolic     syndrome. The primary hypothesis is that MCT supplementation will decrease plasma levels of     intestinal lipoproteins by reducing secretion of these particles.   "
113055|NCT01806129|"     This clinical trial studies reproductive health program in patients with cancer. A     reproductive health program may improve patients' understanding of reproductive risks and     receipt of appropriate treatment to achieve their reproductive health goals   "
113056|NCT01806116|"     Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for     patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse     remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT)     in patients，so that there is the need to continue to look for alternative therapies.     Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation     and expression of silenced genes including those involved in apoptosis. The approval of     decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit     disease progression in transplant-eligible patients. To assess the effect of pretransplant     decitabine treatment on post transplant outcomes, we recently reviewed our institutional     experience with MDS and AML patients.   "
113057|NCT01806103|"     The purpose of the study is to determine if physician education coupled with audit and     feedback of antibiotic prescribing can improve antibiotic prescribing by primary care     clinicians.   "
113058|NCT01806090|"     This double-blind, randomized trial aims to evaluate whether uninterrupted anti-platelet     therapy (clopidogrel) will increase the risk of bleeding associated with removal of polyp     during colonoscopy in patients with coronary artery disease.   "
113059|NCT01806077|"     This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1) in     subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk     factors.   "
113060|NCT01806064|"     Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for     TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma.      Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1     criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib     alone, following failure of one prior VEGF TKI   "
113061|NCT01806051|"     This self-controlled, prospective, pilot study is designed to gather information regarding     the diurnal variation (changes that occur each day) in the levels of plasma phenylalanine     (Phe) and tyrosine in patients with phenylketonuria (PKU) and in the non-PKU population.   "
113062|NCT01806038|"     The goal of this study is to investigate whether pharmacist provided counseling and     medication dispensing at the patient's bedside can provide better outcomes than the current     discharge process at Duke University Hospital. This study will be single-site, prospective,     randomized, cohort study. Patients who meet the inclusion and exclusion criteria, and provide     consent will be included in this study.   "
113063|NCT01806025|"     Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung     infection. Usually severity is determined by the class of CF mutations, but even among     patients with the same severity of mutations there is a variation of the severity of CF.      Haptoglobin has several types (phenotypes), one of them was found to be related to infectious     complications.      In this study the investigators aim to find a correlation between Haptoglobin phenotypes in     patients with CF and frequency of infectious complications.      To this end the investigators will collect serum from CF patients, and determine their     Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to     retrospectively gathered data on infectious complications.   "
113064|NCT01806012|"     The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a     randomized, single-blinded comparison to the conventional procedure. The objective of the     study is to investigate if the use of the Enseal sealing instrument for supracervical     hysterectomy leads to a shortening of the operation time.   "
113065|NCT01805999|"     Chronic constipation is a phenomenon which affects nearly 20% of the population worldwide.     Bulking agents such as ispaghula are used as treatments, but only half of the patients are     satisfied with the treatment. This highlights a need for better treatment options, which     requires a deeper understanding of the gastrointestinal fate of the products. The GI MRI     Research group at the University of Nottingham has been developing new, non-invasive magnetic     resonance imaging (MRI) techniques to image the gastrointestinal tract. In collaboration with     Ironwood Pharmaceuticals, the investigators now want to understand the gastrointestinal fate     of an ispaghula treatment, and also to improve the understanding of MRI parameters when they     are applied to the colon.   "
113066|NCT01805986|"     Magnetization transfer imaging is a magnetic resonance technique that has been used over the     last few years, and known for its ability to detect abnormalities that can be difficult to     detect by conventional MRI techniques.      The investigators would like to test if using an 7 Tesla MRI research scanner can help us     diagnose Multiple Sclerosis more efficiently compared to the current clinical practice, i.e.     if Multiple Sclerosis lesions in Gray Matter can be more readily identified and associated     with disease stage on Magnetic Transfer MRI images as opposed to conventional procedures.     Image analysis will allow the investigators to perform lesion segmentation and sequence     comparison between different MRI techniques. The investigators will apply computation     techniques to measure the local cortical thickness. Repeated scans at 6 monthly intervals     over two years will give an insight into the changes in cortical thickness over time. Based     on obtained data the investigators will look for the relationship between lesion loads in     White Matter and Gray Matter, cortical thickness and disease stage.   "
113067|NCT01805973|"     An abdominal aortic aneurysm (AAA) is an enlargement or ballooning of the main artery     supplying high pressure blood from the heart to the body. AAAs may continue to stretch until     they burst (rupture) causing 7000 deaths per year in the United Kingdom (UK); 2.1% of all     deaths in men over 65. Planned repair before rupture is critical and the National AAA     Screening Programme (NAAASP) is being introduced to identify AAAs in men before rupture.     Screening will identify over 9000 men per year with a previously undiagnosed AAA. More than     90% of screen detected AAAs are small, do no require repair, enter ultrasound follow-up     (surveillance) and may benefit from exercise to improve fitness before repair.      Over 4000 elective AAA repairs per year are performed in the UK and it has been suggested     that exercise training and weight loss may reduce mortality and complications of AAA repair.     This pilot study will examine the feasibility of supervised exercise training for patients     with AAAs and determine the optimal duration of training to achieve worthwhile improvements     in fitness.   "
113068|NCT01805960|"     The purpose of this study is to test the efficacy of a single injection of Canakinumab on AF     recurrences within 6 months after electrical cardioversion in patients with persistent AF.   "
113069|NCT01805947|"     In this observational study the effects of a Lifestyle Modification Program - offered as a     semi-residential day care clinic - on pain, disability, quality of life and satisfaction with     life will be investigated. Furthermore the influence of mindfulness, acceptance and coping,     and acquired changes in lifestyle behaviors on the outcome after the program will be     evaluated.      Effects will be measured after completion of the program (3 months), and at 6 and 12 months     follow up after start of the program, i.e. each outcome measure will be taken 4 times within     12 months.   "
113070|NCT01805934|"     The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not     satisfactory. The study aims to compare the efficacy and safety between quadruple therapy     with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.   "
113071|NCT01805921|"     In this study we are testing a new vaccine against Respiratory Syncytial Virus (RSV).      This virus can cause respiratory infections such as bronchiolitis and pneumonia. It affects     all ages, but especially infants, adults with a suppressed immune system, and the elderly.     RSV only infects humans and occurs in epidemics each winter. It is the single most common     cause of severe respiratory illness in children.      There is no effective anti-viral medication to treat RSV infections. There is a monoclonal     antibody, which can be given to 'at-risk' children given by injection on a monthly basis     during winter to provide short term protection against infection, but it is only partially     effective and prohibitively expensive. Currently, there is no licensed vaccine to prevent RSV     infection and there remains a real need to develop a vaccine as a cost-effective method to     save lives and reduce the cost of disease caused by RSV.   "
113072|NCT01805908|"     The general objective of the study is to improve the care of women with Human Epidermal     Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by     using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography     (SPECT) imaging to predict who will respond to treatment with Trastuzumab.   "
113073|NCT01805895|"     The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral     hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in     intracerebral hemorrhage patients.   "
113074|NCT01805882|"     Background:      - GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV)     infection. GS-7977 may help treat the infection when used with other treatments like     interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the     body. Researchers want to see whether GS-7977 can be combined with any of the other three     drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will     take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451.      Objectives:      - To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can     be used to treat HCV infection.      Eligibility:      Individuals at least 18 years of age who have chronic HCV infection and have never been     treated for it.      Individuals at least 18 years of age who have chronic HCV infection and have not responded to     interferon therapy.      Individuals at least 18 years of age who have chronic HCV infection with advanced liver     disease and have never been treated for HCV      Design:      Participants will be screened with a physical exam and medical history. Blood samples will be     collected. A liver biopsy may also be performed.      Some participants will take the two study drugs and some will take three study drugs. Those     who take GS-7977 and GS-5885 will have one daily tablet named fixed dose combination or FDC.     Those who take GS-7977 and CS-9669 will have three daily tablets taken once daily. Those who     take GS-7977 and GS-5885 and GS-9451 will take 2 pills once a day. GS-7977 and GS-5885 will     be combined in one pill and GS-9451 will be in another pill.      Treatment will be monitored with frequent blood tests. These tests will check liver function     and the level of HCV infection. Participants may have other blood tests as needed for     treatment.      Participants will have 4, 6 or 12 weeks of treatment depending on which study drugs are     scheduled to take. After they complete their schedule, they will stop treatment with the     study drugs. They may also have another liver biopsy.      Participants will have regular follow-up visits over the next 48 weeks. They will have     physical exams and provide blood samples....   "
113108|NCT01805440|"     This is a randomized, double-blind, placebo-controlled study of the investigational drug     uridine as a treatment for depressed adolescents with bipolar disorder (i.e. bipolar     depression). Participants initially randomized to placebo who complete the 6-week protocol     will be offered 6 months of open-label uridine treatment and follow-up. Participants     initially randomized to uridine will be offered the open-label treatment as well.   "
113075|NCT01805869|"     Background:      - The third molars (wisdom teeth) normally grow in during late adolescence or early     adulthood. Many people need or choose to have these teeth removed with oral surgery.     Normally, the removed teeth and tissue are thrown away as medical waste. However, oral health     researchers want to collect the teeth and tissue for research. They also want to encourage     dentists at the National Institutes of Health to improve their skills in oral surgery. This     study will collect the teeth and tissue of people who need to have oral surgery to remove     their wisdom teeth.      Objectives:        -  To provide continued dental skills training for dentists at the National Institutes of          Health.        -  To collect teeth and tissue samples following wisdom tooth removal surgery.      Eligibility:      - Individuals between 16 and 50 who need to have their wisdom teeth removed.      Design:        -  This study will involve a minimum of three visits. There will be a screening visit, a          surgery visit, and at least one follow-up visit.        -  Participants will be screened with a physical exam and medical history. A full dental          exam with x-rays will be given to evaluate the need for surgery.        -  At the second visit, participants will have oral surgery to remove their wisdom teeth.          The teeth and tissue removed during the surgery will be collected for study.        -  Participants will receive drugs to control the pain after surgery. They will also be          able to contact a dentist if there are any problems.        -  Between 7 and 21 days after surgery, participants will have a followup visit to check          the healing. If they are having no problems, this will be the last visit. If there are          any postsurgery issues, they will be scheduled for additional visits as needed.   "
113076|NCT01805856|"     The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site     infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present     prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean     neck surgery associated with thyroid and parathyroid disease.   "
113077|NCT01805843|"     Chronic myelogenous leukemia (CML) is a chronic myeloproliferative disorder characterized by     a translocation between chromosome 9 and 22, leading to a pathogenic tyrosine kinase signal     transduction protein. CML can be treated with tyrosine kinase inhibitors (TKIs), which     inhibit BCR/ABL kinase, such as imatinib. In about 20% of CML patients who are treated by     imatinib, a complete cytogenetic response cannot be achieved. The other two novel TKIs     (dasatinib and nilotinib), achieve higher rates of complete cytogenetic response and they are     proposed as second-line therapy for imatinib-resistant patients or for those who do not     tolerate imatinib. Dasatinib inhibits BCR/ABL kinase in about >300 times in vitro in more     than imatinib and also inhibits several other kinases, including the Src family. Src tyrosine     kinase is crucial for potassium channel function in human pulmonary arteries. Imatinib and     nilotinib do not inhibit the Src.      Incident cases of precapillary PH have been reported in patients who have CML treated with     the dasatinib. Improvements were usually observed after withdrawal of dasatinib.      This study is designed to identify incident cases of dasatinib-associated PH and describe     pulmonary vascular changes induced by dasatinib. As comparison population will be patients     who receive another second-line TKI (nilotinib).   "
113078|NCT01805830|"     The study design of this trial is double blind, parallel-group, randomized, Placebo     controlled study.   "
113079|NCT01805817|"     Oral combined contraceptives(OC) have both progesterone and estrogen inside.     Levonorgestrel-releasing intrauterine device(LNG_IUS) has only progestagen.      Copper IUD does not have any hormonal molecule inside.        -  Hypothesis is OC has more systemic beneficial or side effects than LNG_IUS or copper          IUD. LNG_IUS has more local effects than copper IUD.        -  Study reflects the beneficial or side effects of estrogen+progestagen pills and only          progestogen inside device.   "
113080|NCT01805804|"     Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to     heart failure. The investigators aim to test hypothesis that valsartan started immediately     after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve     months long follow up in comparison with placebo. Echocardiographic assessment of left     ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and     their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and     distance in meters during six minute walking test.   "
113081|NCT01805791|"     A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate     ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3,     taking mesalamine (or equivalent) as a concomitant medication.      The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine     treatment failures). Efficacy will be measured by a comparison of the proportion of patients     in each treatment group attaining clinical remission at Week 8 as compared to placebo.   "
113082|NCT01805778|"     Cancer therapy can place childhood cancer survivors at increased risk for heart disease which     can lead to significant illness or early death. Interventions that occur late in the     evolution of treatment-related heart disease are usually ineffective at preventing its     progression to death or heart transplant. Our team will work in several research cores to     test new imaging and biomarker methods that will lead to earlier detection of heart disease     before clinical symptoms develop or it become apparent on standard imaging tests. We will     evaluate the importance of genetic differences between individuals in determining who is at     greatest risk of developing heart disease as a result of exposure to cardiotoxic agents. We     will combine this genetic information with the novel imaging and biomarker methods to predict     which children are at particular risk. These vulnerable children can then be targeted by     modifying their cancer therapy to reduce their exposure to cardiac toxins, or introducing     medications that protect the heart from chemotherapy damage. This team brings together the     expertise of clinicians and scientists in pediatric oncology, pediatric and adult cardiology,     radiation oncology, genetics, and biostatistics. This is a cross-Canada initiative that will     leverage the latest knowledge about cardiac toxicity and create a resource for ongoing     research into this important cause of morbidity and mortality in childhood cancer survivors.   "
113083|NCT01805765|"     The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is     effective in alleviating menopausal symptoms and safety.   "
113084|NCT01805752|"     Each year, an estimated 230,000 HIV-infected women in need of services for prevention of     mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other     nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global     Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These sites     are predominantly rural primary health centers (PHCs) where shortages of high-cadre health     care providers and insufficient laboratory capacity to perform CD4+ cell count testing have     been major barriers to effective PMTCT scale-up. A systematic reassignment of patient care     responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell count testing     will facilitate the ability of lower-cadre health providers to manage PMTCT care, including     the provision and scale-up of antiretroviral treatment (ART) to pregnant women in these     rural, decentralized sites. A system wherein men are facilitated to accompany their wives to     ANC appointments will create an important opportunity to address entrenched gender norms. The     investigators therefore propose using community and facility-based measures to encourage male     partners to accompany their spouses for ANC. As influential community members, male partners     can assist their spouses to utilize culturally-sensitive, sustainable and integrated PMTCT     care provided by lower-cadre providers in these resource-constrained settings.      The investigators propose a parallel, cluster randomized trial to evaluate the impact of a     family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at     PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a     prominent role for influential family members (male partners), working in close partnership     with community-based health workers/volunteers. The specific aims of this study are:        1. To evaluate whether implementation of the integrated PMTCT package in primary level          antenatal clinics (ANC) increases the proportion of eligible pregnant women who initiate          antiretroviral medications for the purposes of PMTCT. The investigators hypothesize that          the provision of the PMTCT package in intervention clinics will improve PMTCT          antiretroviral uptake rates among eligible women during pregnancy from 40% to 65%.        2. To determine whether implementation of the PMTCT package improves postpartum retention          of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum          retention rates among mother-infant pairs attending intervention sites will be >20%          higher at 6 weeks when compared to mother-infant pairs receiving care in          non-intervention sites.        3. Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT          intervention compared to the existing standard-of-care referral model. The investigators          hypothesize that the proposed intervention will be more cost-effective than the existing          model of care.      In addition, two qualitative evaluations will be conducted in order to:        1. Assess client satisfaction with health services, comparing PMTCT services provided by          lower level vs. higher level cadre health workers; and        2. Evaluate health care worker satisfaction with the new PMTCT service delivery model.   "
113327|NCT01802580|"     To evaluate whether participation in an Internet-based intervention helps improve short-term     and long-term psoriasis treatment outcomes, in particular, adherence.   "
113085|NCT01805739|"     Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic     stenosis for patients ineligible for open heart surgery or at high risk for perioperative     complications. Pre-procedural imaging of the aortic root is essential for selection of the     correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly     subsequent embolization, coronary obstruction, annulus rupture or severe aortic     regurgitation.      The aim of the study is to compare the different imaging modalities for aortic root     measurements.      Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be     performed either into the aorta or into the left ventricle. The datasets will be assessed by     blinded-independent observers in a multi-planar reconstruction view.      The study will be performed retrospectively (2009-2012) and prospectively starting 2013.   "
113086|NCT01805726|"     The purpose of this study is to find the best sedation necessary for patients undergoing     bronchoscopy. Patients are randomized to three different regimes of sedation during     bronchoscopy were studied:        1. - Group standard/control: local anesthesia only(C)        2. - Group alfentanil + local anesthesia(A)        3. - Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy          score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy          examination. Measured parameters on the safety of examination are: the lowest          saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and          if the patient is ready or not to undertake bronchoscopy second time in his life if          necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen          are collected every 5 minutes before, during and after the bronchoscopy.   "
113087|NCT01805713|"     Cystic fibrosis (CF) is the most common autosomal recessive genetic disease in Caucasians. It     results in lung disease that affects quality of life and causes early death. Lung damage from     CF starts in infancy and continues over time. Lung damage can negatively affect how the lung     functions. It would be ideal to measure lung damage in CF patients in three instances: (1)     During the first year of life after diagnosis by state newborn screening programs, (2) In     children and adults over long periods of time (years), and (3) During times of illness     (pulmonary exacerbation), to allow for better treatment and therapy to prevent loss of lung     function. The lung is made of elastin, collagen and cartilage. When the lung is damaged by     CF, these components break down into pieces that can be measured in urine, sputum and blood.     These products may represent markers of lung injury. We believe that the levels of these     markers will be increased over time in CF patients and even higher in patients who are sick     with lung symptoms. The goal of my research is to measure the amount of lung breakdown     products in urine, sputum and blood in infants, children and adults with CF during times when     well and also during times of illness. I also hope to use new technologies involving the     study of proteins and metabolites in samples like sputum, urine and blood to help provide new     information regarding CF lung disease. These studies will help us to better treat CF lung     disease.   "
113088|NCT01805700|"     The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on     blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive     performance in patients with type 1 diabetes.      Knowledge acquired may inform a wider study of the impact of these drinks.      This is a randomised, cross over blinded study in which all participants will participate in     the 3 arms of the study.      The study will consist of 3 phases, each lasting 3 days. A different study drink will be     administered during each phase. There will be an initial screening visit and a pre- study     visit before each study phase. Each participant will make 10 visits to the research centre.      There will be a week wash out period between each study phase. Prior to each study phase,     there will be a 3 day caffeine and alcohol abstinence run-in period.      Study drinks will be matched for taste and volume (as far as possible) and will be     administered by the use of opaque cups, lids and straws to enable double-blind randomisation     for both researcher and participants. Administration of the study drink to participants will     be based on Latin squares to provide a balanced treatment order.      During the 3 days study period; participants will be required to abstain from all other     caffeine containing beverages or confectioneries.      The secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced     energy drinks is developed following acute short term ingestion.   "
113089|NCT01805687|"     Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable     asthma.   "
113090|NCT01805674|"     In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural     symptoms, globally worsens the quality of daily life.      The improvement of the quality could be reached with adequate food supplements, named     phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with     estrogen-like and estrogen-antagonistic activity, which are active in the control of     menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the     psychological symptomatology also improving the quality of life.   "
113091|NCT01805661|"     To compare early ambulation and ability to participate in rehabilitation in patients     undergoing total knee replacement using two different nerve block techniques for pain     control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2)     femoral nerve block with tibial nerve block   "
113092|NCT01805648|"     The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance     treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of     rhTPO .   "
113093|NCT01805635|"     The aim of this study is to assess the influence of kind of allergic disease, allergic     profile, allergen exposure, treatment method on lung function parameters, fractional exhaled     nitric oxide level in children suspected and being diagnosed due to allergic diseases.   "
113094|NCT01805622|"     -  Hypothesis 1. When compared to passive dissemination, active dissemination will result          in greater participant enrollment.        -  Hypothesis 2. The intervention will be offered with equal fidelity in churches, clinics          and community sites.        -  Hypothesis 3. Knowledge of CRC screening and perceived risk of CRC will be positively          correlated.   "
113127|NCT01805193|"     Coronary heart disease is a very common condition caused by narrowings in the blood vessel     supplying the heart. the investigators are studying new tests to diagnose heart disease. In     this study the investigators plan to investigate a special scan called a PET/CT (Positron     emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to     tell us about the flow of blood to the heart muscle.   "
113095|NCT01805609|"     The purpose of this study is to provide a communication training program to inpatient nurses     and social workers at Memorial Sloan Kettering Cancer Center in order to help them assist     caregiving families. The importance of this training program is that it aims to teach nurses     and social workers how and when to respond more effectively and compassionately to challenges     faced by caregiving families. One of the goals of this program is to address family support     needs during a patient's hospitalization.   "
113096|NCT01805596|"     This study is to assess the function of blood vessels while being treated with different     types of blood thinners to determine the effect of these medications on blood vessels.   "
113097|NCT01805583|"     Evidence-based clinical treatments for common mental disorders, such as CBT and/or     pharmacotherapy, have resulted in significant and sustained improvement in clinical symptoms.     However, the individual-focused treatments rarely have sickness absence as a target of     intervention or evaluate work-related outcomes, such as return to work. A recent review of     the evidence for managing stress at work showed that individual interventions give effects on     mental health measures but did not impact absenteeism at work. The purpose of this study is     to examine the efficacy and cost-effectiveness of two different rehabilitation models, one     based on psychotherapy and the other on workplace-interventions, when these are offered as     standalone interventions and in combination for patients with adjustment, anxiety and     depressive disorders.   "
113098|NCT01805570|"     The aim of the RAPID study is to evaluate the superiority rapid onset of action of Ticagrelor     360 mg LD versus Prasugrel 60 mg LD, in 50 patients with STEMI (ST segment elevation     myocardial infarction) undergoing PPCI with bivalirudin monotherapy. Secondary study aim is     to found out clinical predictors of high residual platelet reactivity in the first hour after     a novel oral antiplatelet agent LD.   "
113099|NCT01805557|"     The probability to achieve CR with R-chemotherapy in patients failing a rituximab containing     first line regimen is quite low, in particular in cases with non GCB profile. The bioCORAL     trial suggest that ABC subset have a dismal outcome whichever the induction treatment. Thus     it can be argued the addition of new molecule to the RDHAP regimen could be of value.     Bortezomib appears the best candidate in this setting as ABC subtypes constitutively express     NFkb, which is the target of bortezomib itself. Data from the literature suggest an     encouraging activity of R-chemo+ bortezomib in non GCB-derived DLBCL, although in small     series. Thus, the addition of bortezomib is here justified by the need to circumvent     constitutional resistance to chemotherapy. Published experience of the association between     bortezomib and cytarabine are also encouraging with acceptable cumulative toxicity.   "
113100|NCT01805544|"     National, multicenter, prospective, observational, non-interventional study. The objective is     to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated     with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and     pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after     3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS)     score.   "
113101|NCT01805531|"     National, multicenter, prospective, observational, non-interventional study. The objective is     to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated     with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated     with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction     will be measured by the Anti Clot Treatment Scale (ACTS) score.   "
113102|NCT01805518|"     Phosphodiesterase is a candidate for the Rx & prevention of cognitive and psychotic     disorders. Since caffeine targets primarily PDE4(Phosphodiesterase subtype 4), caffeine     analogs have been developed to mimic the actions of caffeine's ability to inhibit PDE-a,     PDE4, PDE5 and adenosine-2 (AD-2)but are limited by the side effects of insomnia and     heightened anxiety. Sildenafil (PDE-5 inhibitor) fails to enhance cognition in schizophrenia.      The study of PDE-4 in cognition in Alzheimer's dementia and schizophrenia has been done using     the PDE-4 prototypal compound, rolipram, which improves cognition in rodents. Rolipram     reverses the memory deficits induced by amyloid fragment Abeta25-35 and Abeta1-40 peptide. In     humans the frequent side effect of vomiting hampers translational research. The clinical     trial of rolipram in multiple sclerosis was terminated prematurely due to serious adverse     events with paradoxical increases in MRI MS-specific brain lesions. However, PDE-4 remains     paradigm for cognition.      Another strategy is chemical moieties capable of antagonizing the PDE-4 through allosteric     modulation, rather than direct competitive inhibition hoping to minimize adverse events while     retaining the biological potencies and functional responses of PDE-4 Modulators. Dietary     supplements with PDE-4 effects have advantages in that small investments are needed to     adequately study them.      Pharmacologically active chemicals of Sceletium species are mesembrine-type alkaloids that     have proven PDE-4 activity. The PDE-4D knockout mice have enhanced memory function mediated     through hippocampal neurogenesis via phosphorylated cAMP response element binding protein     (pCREB) signaling.      This study purpose is to delineate the relationship of PDE-4 and cognition in normals. pCREB     is possibly the putative biomarker of PDE-4 response with CREB as effector signaling pathway     of PDE-4. CREB is close to nuclear receptors represented by BDNF (Brain Derived Neurotrophic     Factor) and PPAR (Peroxisome Proliferator Activating Receptor) complexes. CREB changes in     neuronal plasticity are targets for pharmacological paradigms for cognitive enhancement. This     study will use the scelectium tortuosum as manufactured as Zembrin®. The findings in control     subjects will form the basis for designing future studies of Zembrin® in neurodegenerative     disorders with marked cognitive impairment such as Alzheimer's Dementia and Parkinson's     Disease.   "
113103|NCT01805505|"     Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal     ultrasound guidance was proposed recently to provide better visualization and reduce patient     discomfort as embryo transfer can be performed with an empty bladder in this case. The     purpose of this study is to determine whether there are any differences between transvaginal     and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient     satisfaction, and treatment outcome.   "
113104|NCT01805492|"     The purpose of this study is to characterize changes in gene and protein expression in     peripheral blood in patients with, or at risk for, heart disease during an intensive     lifestyle modification program.   "
113105|NCT01805479|"     The purpose of this study is to determine the feasibility of successfully delivering moderate     intensity aerobic exercise training to depressed traumatic brain injury subjects between one     and three years after injury.   "
113106|NCT01805466|"     The primary purpose of this study is to assess the effects of the use of EVADO with respect     to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality.     As secondary aim this study wants to conduct appropriate laboratory investigations in order     to detect the major biological mechanisms potentially responsible for the beneficial effects     of the EVADO system on the coagulation cascade and inflammatory activation.   "
113107|NCT01805453|"     To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema     in newly diagnosed glioblastoma patients.   "
113109|NCT01805427|"     The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse     Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according     to the body weight or body composition and therapeutic monitoring may be necessary in     overweight HIV patients.      The investigators aim at measuring the individual trough concentrations of interest [at     steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.   "
113110|NCT01805414|"     A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may     not be ideal for patients with diabetes. This concern is particularly pertinent to the     breakfast meal, which often contains mainly CHO. Clinical observations suggested that such     diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital     no concentrated sweets (NCS) breakfast meals with more balanced meals. The study team     hypothesized that a balanced breakfast would improve pre-lunch BG values.      This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward     A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD).     Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure     (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All     patients on Ward A (with and without diabetes) were given the intervention breakfast for the     first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS     meals). After 4 weeks, the standard and intervention wards were switched. Data were collected     only on patients with diabetes who were able to consume meals.   "
113111|NCT01805401|"     In this study the investigators aim to assess whether transcranial direct current stimulation     (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions)     when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and     impulse control in healthy participants.   "
113112|NCT01805388|"     The purpose of our study is to characterize the composition of the hard and soft tissues     present after regenerative endodontic procedures in root canals of teeth previously diagnosed     with the need for extraction for orthodontic treatment and incomplete root formation.     Although the protocol addressed in this study is currently being used in clinical practice,     there are no prospective clinical trials investigating its efficacy in stimulating continued     root development and the nature of the newly formed tissues.   "
113113|NCT01805375|"     The main aims of this clinical study are to find out the maximum dose that can be given     safely to patients, the potential side effects of the drug and how they can be managed. The     study will also look at what happens to Anti-CD19 (DI-B4) inside the body.      DI-B4 is a type of drug called an Anti-CD19 monoclonal antibody which is being used to stop     the growth and kill cancerous immune cells by targeting the B-cell marker (CD-19) expressed     on their surface. This drug has not been given to patients before.      DI-B4 will be given weekly by intravenous infusion for four weeks. The study is in two parts.     In Part 1, small groups of patients will be treated at increasing doses to find the highest     safest dose and best dose for part 2 of the study. Approximately 16-20 patients will be     treated in this part. In Part 2, the dose identified in Part 1 will be given to approximately     20 patients.      Patients recruited to the study will receive four weeks (cycles) of treatment. They will     attend an end of therapy visit eight weeks after their last dose of DI-B4, and attend     follow-up visits up to eighteen months after their first dose of DI-B4. Information on the     overall and progression free survival will be collected for a period up to eighteen months     after the final patient is treated on the study.      Patients will have blood and urine samples taken each week during treatment amongst other     clinical tests. CT scans will be performed at the start of the study, at eight weeks post     treatment and six months after the study start. Bone marrow biopsies and FDG-PET scans will     only be taken if needed. Research blood samples will also be taken to look at what happens to     the drug inside the body.      It is important to explain that patients will have advanced cancer so it is unlikely that     patients will benefit directly from taking part but the study may help improve future     treatment of cancer.   "
113114|NCT01805362|"     Objective:      To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given     at bedtime compared to on awaking, and to analyze the determinants and consequences of     aldosterone breakthrough.      Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design:     prospective, multicenter, randomized, controlled, open label, two parallel groups.      Main selection criteria:      Inclusion criteria        -  Chronic kidney disease stage 3 to 4,        -  ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or          irbesartan) on awaking for at least three months,        -  History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.      Exclusion criteria        -  Office blood pressure ≥ 160/100 mmHg,        -  Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide,          amiloride), or direct renin inhibitor.      Evaluation criteria:      Primary: Serum aldosterone levels at one year.      Secondary:        -  Serum aldosterone/renin ratio,        -  24h urine aldosterone,        -  Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone          levels over baseline values,        -  Aldosterone breakthrough defined by an increase of serum aldosterone levels over          baseline values,        -  HbA1c,        -  Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,        -  Systolic home blood pressure (SBP),        -  Estimated glomerular filtration rate (eGFR) using the MDRD equation.   "
113115|NCT01805349|"     Among the risk factors for lower limb osteoarthritis, if obesity is probably the most     studied, digital osteoarthritis received increasing interest in recent years. Recent     publications have highlighted a link between obesity and digital osteoarthritis, but also a     very probable link between digital osteoarthritis and structural progression of knee     osteoarthritis. Few data including hip exist and need to be confirmed on larger scale     studies. We have with Khoala a national multiregional cohort of symptomatic gonarthrosis     and coxarthrosis representative of the general population (which is rarely the case in the     literature) including X ray, clinical and biological follow-up (hips and / or knees).   "
113123|NCT01805245|"     The purpose of this study is to evaluate the impact of stress reduction on physiological and     psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe     levels of diabetes-related emotional distress. Subjects will be randomized to one of two     interventions. We will evaluate the impact of the interventions on glucose metabolism, blood     pressure, diabetes-related distress and quality of life. Additionally, we will investigate     the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care     practices as mediators in the relationship between increased stress, adverse glucose     metabolism and elevated blood pressure in those subjects with T2DM.   "
113124|NCT01805232|"     Intravenous artesunate is egual to quinine in the treatment of severe malaria   "
113125|NCT01805219|"     The aim of the study is to validate the association of the GPS and accelerometer tools in     order to assess the humain locomotion during exercises.      The hypotheses are:        1. GPS and accelerometer together can assess the human locomotion        2. GPS and accelerometer together can assess the energy expenditure during exercises   "
113116|NCT01805336|"     Since many years cognitive disorders are a main topic of clinical research in Multiple     Sclerosis (MS) as there could be observed early on in the disease and could induce with time     in patients significant socio-professional burden. Today assessment of cognitive dysfunction     in MS is still based on traditional pencil-paper task tests which are not able to give a true     representation of functional burden observed in patients in real life situations. The     development of new tools close to these life situations, i.e. more ecological, are needed     to better assess and take in charge cognitive impairment in MS patients. One way to reach     this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that     simulates a realistic 3D environment where the user become immersed and interacts with it.     These last ten years VR has known a rapid development in the health domain and has been     applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last     domain, virtual environment (VE) reproducing activities of daily living have been used to     evaluate executive and memory functions as well as attentional or visuospatial processes.     Among main VE developed, driving assessment system, navigation skills, cooking behaviors,     virtual supermarket have shown better sensitivity to detect functional consequences of     cognitive impairment in various neurological and psychiatric disorders than traditional     evaluations. In Caen University Hospital, investigators used VE driving system and developed     the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a     user move to select and buy groceries and other things inside an interactive virtual     supermarket using a shopping cart. In a preliminary study investigators have used this     virtual interactive tool to evaluate executive functioning in small group of Parkinson's     disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use     with these two kinds of diseases. According to these results investigators planned a new     study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving     system and the VAP-S) to traditional attentional and executive evaluation for estimate their     respective sensitivity to detect cognitive/functional impairment in MS patients.     Investigators hope to shown that VR will demonstrate its interest to assess cognitive     functions in MS and to develop cognitive rehabilitation.   "
113117|NCT01805323|"     This retrospective chart review study will describe the history of patients with retinal     disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is     administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously     administered according to general clinical practice.   "
113118|NCT01805310|"     Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative     mechanical bowel preparations in attempts to decrease the risk of infection, while also     providing easier bowel manipulation and better visualization during surgery. However, many of     these proposed benefits have never been proven, and usage of bowel preparations amongst     surgeons remains highly variable. In both the general surgery and gynecology literature,     researchers have begun to question the need for the vigorous preparations.      Aside from surgical visualization, urogynecologists have additional concerns about how bowel     preparations may impact postoperative bowel function given up to half of women with pelvic     floor disorders have baseline constipation and straining is known to impact surgical     recovery. Many studies have addressed various postoperative fiber and laxative preparations     in attempts to improve postoperative bowel-related symptomatology, but none have specifically     looked at preoperative bowel preparations.      This study aims to determine if mechanical bowel preparation prior to minimally invasive     sacral colpopexy affects patients' postoperative recovery, specifically related to bowel     symptomatology; operative or post-operative complications; surgeons' perceptions of surgical     difficulty directly attributed to the bowel; and post-operative return of normal bowel     function.   "
113119|NCT01805297|"     To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients     undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.   "
113120|NCT01805284|"     The objectives of the study are:      (i) to evaluate the proportion of patients who attain a T>MIC (Minimum Inhibitory     Concentration) of 100% and the time frame in which they do so. The investigators therefore     plan to measure unbound linezolid trough concentrations before administration of the second,     third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC     in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or     fifth dose, when steady state conditions are reached.      (ii) to describe the pharmacokinetic variability of unbound linezolid concentrations in this     cohort using a population pharmacokinetic model and to assess the expected probability of     target attainment (PTA) by MIC against MRSA.      Twenty adult, MRSA-positive, morbidly obese patients with clinically and radiologically     documented pneumonia are to be included. Therefore, a multi-centre, international     observational study is necessary. Given the specific target population this study is not     feasible in a single-centre approach. The goal is to find up to 6 centres that anticipate     including 3 to 4 patients in the study within a time frame of one year.      Included patients should receive at least 6 doses of linezolid. Linezolid must be     administered intravenously (iv) over a one hour controlled infusion (with use of a volumetric     infusion pump).   "
113121|NCT01805271|"     A significant number of patients relapse and eventually die, particularly if they were     initially diagnosed with large nodes involvement and/or T3/4 diseases. When analyses focus on     patients with ER+/Her2-negative breast cancer, with ≥4N+, 30% had relapsed at 5 years,     emphasizing the need for new drugs in this setting (PACS01 data, UNICANCER internal data).      Strong evidence suggests that cross-talk between the phosphatidylinositol 3-kinase     (PI3K)/AKT/mammalian target of rapamycin (mTOR) pathway and ER signaling is linked to hormone     resistance in breast cancer patients.      In the present study, we plan to evaluate the benefit from adding everolimus to standard     endocrine treatments after three years of treatment for patient ER+/HER2- at high risk of     relapse due to high nodes involvement (≥4) and/or persistent node involvement after     neo-adjuvant chemotherapy.      Genomic signatures have emerged during the last 10 years as a new and additive means to     evaluate more precisely long term prognosis, and in some instances the amount of benefit from     chemotherapy or endocrine therapy in the adjuvant setting. Therefore the UNIRAD study can be     proposed to patients with 1-3 positive lymph nodes at primary surgery and a high risk of     relapse with the EndoPredict test.      This study is a unique opportunity to prove the efficacy of everolimus in adjuvant setting.     The study could be practice changing in case of positive results and could allow improving     outcome of breast cancer patients presenting high risk of metastatic relapse.   "
113122|NCT01805258|"     The purpose of the study is to evaluate the efficacy and safety of Nevarapine and Rifampicin     vs Efavirenz and Rifampicin in antiretroviral naive patients co-infected with HIV and TB and     to investigate whether Rifampicin co-administration in clinical practice leads to a     clinically relevant decrease of Nevirapine plasma concentrations in Indian patients     co-infected with HIV and Tuberculosis and to characterize drug-associated toxicities     (especially hepatic).   "
113126|NCT01805206|"     During the first four days of life, intestinal fatty acid binding protein (iFABP) is elevated     in the urine of premature babies who go on to develop necrotizing enterocolitis (NEC) days to     weeks later. This study aims to determine whether the withholding of feedings in babies with     an elevated urinary iFABP can reduce the incidence of NEC.   "
113129|NCT01805167|"     Differences in speech-understanding and the quality of the subjective perception among     cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field     distribution (interaction between electrodes) could also explain the disparity of the     performances? The objective of our study was to quantify the influence of the electrical     field interactions between the channels of stimulation according to the vocal performances of     the implanted subjects, for various subjective levels of electric stimulation.   "
113130|NCT01805154|"     The intent of this registry is to understand comprehensive clinical care strategies for     Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world     clinical practice.   "
113131|NCT01805141|"     The investigators hope to learn whether perfusion CT is a useful way to assess primary     cervical tumor microenvironment and whether there is a relationship between pretreatment     perfusion CT measurements and primary cervical tumor size, lymph node involvement (as     assessed by standard of care pretreatment fludeoxyglucose Positron emission tomography/CT     (FDG-PET/CT)), and treatment response (as assessed by standard of care 3-month post-therapy     FDG-PET/CT).   "
113132|NCT01805128|"     The schizophrenic disorders and pervasive developmental disorders are neurodevelopmental     disorders distinct origin who share common challenges to engage and maintain social     relationships and mutual disturbances of affective contact. An important issue of research is     to determine the cognitive and brain mechanisms underlying social disability in these two     pathologies. Several lines of social cognition have been systematically explored: the     perception of emotions, the ability to attribute intentionality and mental states to others     (theory of mind), the understanding of social situations in different contexts. We made the     observation today that research findings clearly in the field of autism and schizophrenic     disorders that converge on common patterns neurocognitive abnormalities. Consequently, many     programs support published today use the same therapeutic targets and the same tools in both     pathologies. This raises two questions of science: (1) whether the disorders of social     cognition reported in the field of autism and schizophrenia are specific deficit and not     specific condition, that is to say they are inherent social disadvantage whatever condition     or (2) if these disorders of social cognition is a pattern common to autism and schizophrenia     but are the result of specific neurocognitive mechanisms and different in each these     pathologies. Systematic exploration of these issues is a current issue for understanding the     pathophysiological borders between the two neurodevelopmental disorders but also to better     define the potential targets of therapeutic strategies, psycho-educational and remediation of     disorders of social cognition in autism and schizophrenia.      Main objective: To compare clinical cognitive profiles in adolescents with a schizophrenic     disorder, autistic or healthy in the three areas of social cognition: perception of emotions,     attribution of intentions to others (theory of mind) and style attribution. We shall     constitute three population groups of patients, a group of patients meeting the diagnosis of     schizophrenia, a group of patients with autism and a control group (healthy subjects).   "
113133|NCT01805115|"     The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no     misoprostol prior to operative hysteroscopy in premenopausal women.   "
113134|NCT01805102|"     PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta.      Except for serum hCG, no pregnancy-complication markers are widely employed to predict the     need for medical intervention. Since circulating PIF is present from very early and     throughout viable pregnancy, it may represent a specific biomarker candidate. PIF levels will     be analyzed in serum of pregnant women in a range of settings: a) following IVF; b) index     pregnancy of women with history of recurrent pregnancy loss, c) index pregnancy of women with     history of placenta mediated complications such as: intrauterine growth restriction,     spontaneous idiopathic preterm delivery, and preeclampsia; and d) index pregnancy in women     with evidence of abnormal placentation, namely placenta accreta and related conditions.   "
113135|NCT01805089|"     The purpose of this research study is to determine whether melatonin taken every night can     affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen     are normally produced in the body and may influence breast cancer risk. Melatonin is also     naturally produced in the body. Laboratory studies have shown that melatonin may decrease     cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot     flashes, and mood will also be measured.   "
113136|NCT01805076|"     The purpose of this study is to test whether patients undergoing a breast MRI (magnetic     resonance imaging) before breast surgery will have better results after the surgery. Breast     tumors are routinely evaluated using mammograms and ultrasound before surgery. This study     would like to find out if using MRI in addition to mammography before surgery improves our     ability to evaluate tumors and decide what kind of surgery is best for the patient.   "
113137|NCT01805063|"     Firefighters are at increased risk of death from heart attacks when compared to other     emergencyy service professionals whose jobs involve similar components such as emergency     call-outs and shift work. In the largest analysis of cause of death amongst on-duty     firefighters, firefighter deaths were classified according to the duty performed during the     onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a     cardiovascular cause (i.e. heart attack) occurred during fire suppression whilst this     activity represented a relatively small amount of a firefighters professional time. There was     also a risk of death associated with other duties such as emergency non-fire response and     physical exertion.      The investigators hypothesize that participation in active fire-fighting duties impairs blood     vessel function and increases blood clot formation when compared with non-fire-fighting     activities. In this study, healthy career firefighters will be assessed after three periods     of duty: fire-suppression, emergency response without fire suppression and following a     sedentary shift. The investigators will take blood samples to measure platelet activity     (platelets are the particles in blood that help blood clot) and will examine how blood clots     outside of the body. The investigators will then perform studies placing small needles in the     arm to assess blood vessel function following these duties. By undertaking this comprehensive     assessment of blood, blood vessel and heart function the investigators hope to understand the     mechanisms whereby the risk of a heart attack, fatal or otherwise, is posed throughout these     distinct duties that firefighters undertake on a daily basis.   "
113138|NCT01805050|"     This study shows a new technique which has been implemented at the schulthess clinic to     improve the outcome after an correction of an anterior instability in the shoulder joint due     to a HAGL lesion.   "
113139|NCT01805037|"     The purpose of this study is to evaluate how safe and effective the combination of two     different drugs (brentuximab vedotin and rituximab) is in patients with certain types of     lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor     marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related     lymphoma) and who have not yet received any treatment for their cancer, except for     dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of     transplanted organs (for those patients who have undergone transplantation). This study is     investigating the combination of brentuximab vedotin and rituximab as a first treatment for     lymphoma patients   "
113142|NCT01804998|"     Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric     cancer is less invasive method which can increase quality of life. For last two years,     multicenter quality control study (Phase II) has been performed in Korea and tolerable     results were observed. Based on these results, multicenter phase III trial is required to     validate the clinical role of laparoscopic sentinel lymph node biopsy.   "
113143|NCT01804985|"     The purpose of this study is to investigate whether some patients with excellent responses to     chronic myeloid leukaemia (CML) treatment are being overtreated, and can remain well on     either a lower dose of treatment or without treatment at all. The dose of imatinib (Glivec),     nilotinib (Tasigna) or dasatinib (Sprycel) treatment will initially be cut to half the     standard dose for 12 months, and then treatment will be stopped completely for a further two     years. The trial information will also help to develop a de-escalation and stopping strategy     for future newly diagnosed CML patients in the next British national CML study (to be known     as SPIRIT3).   "
113144|NCT01804972|"     This study aims to determine the usefulness of providing patients with web-based     electronically accessed patient information when compared to the provision of written     information leaflets.   "
113145|NCT01804959|"     SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment.     Probiotics may have beneficial effects on symptoms as supported by one small open-label study     (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of     probiotics. This study aims to determine (i) whether 60 days of VSL#3 probiotics result in     greater GI symptom improvement than placebo in SSc outpatients, assessed using an     interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60     days versus 120 days of probiotics result in greater GI symptom improvement in SSc     outpatients, assessed using the GIT questionnaire.   "
113146|NCT01804946|"     The purpose of this study is:        -  to assess clinical efficiency of Ergoferon for treatment of influenza        -  to assess safety of Ergoferon for treatment of influenza        -  to compare efficiency of Ergoferon and Tamiflu for treatment of influenza   "
113147|NCT01804933|"     Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia     often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The     use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many     anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative     administration of muscle relaxants had to be minimized in spite of poor surgical conditions.      This study, however, is designed to test the hypothesis that profound neuromusclular blockade     reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative     analgesic requirement.On the other hand,profound muscle relaxation can decrease postoperative     diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative     pulmonary function.   "
113148|NCT01804920|"     Presently no generally effective treatments for tardive dyskinesia (TD) are available.     D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric     modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous     studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which     are caused by treatment with presently used antipsychotics drugs.      The hypothesis under investigation in the present study is that D-serine adjuvant treatment     may improve TD in schizophrenia patients diagnosed with this disorder.   "
113149|NCT01804907|"     To establish with a prospective randomized placebo-controlled study the feasibility of     allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means     of improving HIV/AIDS treatment adherence.   "
113150|NCT01804894|"     Field tests are convenient, simple tests that serve as estimates of components of athletic     performance like power speed, and agility. It is thought clinically, that those who do best     at these tests will perform the best in their sport and/or be the least likely to get     injured. The converse is also thought to be true. The objective of this study is to     administer field tests to athletes at the beginning of each season and then follow athletes     over several years, tracking their injuries and their performance statistics. In this way,     the investigators can determine if the clinical supposition is true and that the results of     field tests are associated with injury or performance   "
113151|NCT01804881|"     Dietary management is an integral aspect of self care for many chronic diseases. Craving     Change™ is a standard program already offered at many Family Health Teams (FHT) to patients     interested in being more mindful of their food choices. The program helps patients understand     why they have difficulty with modifying behaviours associated with diet, addresses the impact     of emotion on eating behaviour and provides affect regulation strategies. Existing literature     shows that emotion has a strong effect on food choice and that emotion regulation can lead to     improvements in food choice. Craving Change™, however, is currently not selectively offered     at FHTs to patients deemed to be at higher risk of cardiovascular disease and has not been     evaluated in that context. For this study, we propose to 1) Selectively target patients at     higher cardiometabolic risk; and 2) Evaluate an effect of the program (as modified to address     chronic diseases) through a pilot Randomized Controlled Trial (RCT). If found to be     effective, the modified Craving Change™ program, called Beyond the Fork: A health-centred     approach to managing chronic disease, could be broadly implemented within Family Health     Teams.   "
113164|NCT01804712|"     There is now substantial evidence that B cells are recruited into prostate cancers by CXCL13     released by the tumor cells. B cells release lymphotoxin which drives malignant cell     proliferation through the NFkB pathway. This is a pilot trial in 18 patients to determine     whether depletion of B cells by rituximab will result in a decrease in the extent of B cell     infiltration of the prostatic cancer. The extent of infiltration in the diagnostic biopsy     will be compared to that in the prostatectomy samples following administration of 4 weekly     doses of rituximab.   "
113176|NCT01804556|"     Nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. It     occurs suddenly and induces pain. Patients with frequent nocturnal leg cramps suffer from     sleep disturbance in company with pain. In the present study, we examined the effects of the     myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg     cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger     points on gastrocnemius muscle.   "
113152|NCT01804868|"     Objective: The aim of this study is to assess the efficacy of a web tutorial based on case     vignettes as a complementary tool for teaching literature critical assessment to nursing     students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students'     point of view on research participation.      Participants: Nursing second-year students from 3 universities in Paris (Paris Descartes     University, Paris Diderot University and Paris 13 Nord).      Design: A randomized controlled trial will assess the teaching efficacy of a case vignettes     based tutorial compared to no tutorial. In order to preserve a minimal blinding of     participants, the comparator will be a basic passive teaching presentation on internet. The     students will be randomized in two parallel groups. They will be evaluated on a final case     vignette, and will be invited to follow the other intervention after evaluation. The     allocation of participants will be done by a computerized randomization list, the sequence     will be created by an independent statistician with a ratio 1: 1: 1. Since the students     follow courses in different nursing institutes for each university which may have different     teaching content and organization, the randomization will be stratified by nursing institute.     Allocation concealment will be provided because only the statistician will have access to the     randomization list. All the participants will receive an individual mail linking them to his     group dedicated website. In order to preserve a minimal blinding of participants, the     comparator will be a passive presentation and the participants will not be informed of the     intervention evaluated and will have the opportunity to follow the other intervention after     the evaluation. In parallel, both groups will follow normally their university courses.      Intervention: A case vignette is a clinical scenario based on clinical practice. It will ask     a clinical problem the student will have to answer by reading a research article on a     randomized clinical trial. Then he will have to answer questions about this article which are     related to the major methodological points of a randomized trial. All these steps are     available on a secure website.      Outcomes: The primary endpoint will be the student's knowledge of critical assessment of     randomized controlled trials. It will be measured by students' score on an evaluation case     vignette with multiple choice questionnaires. The secondary endpoints will be the quality     perception and acceptance of the tutorial and if the tutorial has modified their perception     of research participation. Responses will be ranged by a 5-point Likert scale.      Potential interests: This study takes place in the field of nursing universitary teaching.     Nursing students have entered recently the universitary education system which enhances the     nursing research, an emerging field in France.      The investigators hope that this complementary teaching tool will enhance the knowledge and     participation of nurses in research.      Sample size expected: 506 participants.   "
113153|NCT01804855|"     Though face-to-face treatment of childhood obesity can be effective, it is time consuming and     costly. This study will test whether treatment can be delivered via an Android app and     whether such treatment reduces obesity.   "
113154|NCT01804842|"     This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered     once daily in the morning (qAM), administered once daily in the evening (qPM), and     administered twice daily (BID) on circulating glucose concentrations and metformin     pharmacokinetics (PK) in subjects with type 2 diabetes mellitus (T2DM).   "
113155|NCT01804829|"     The purpose of this study is to test the safety and efficacy of Civacir® to prevent the     recurrence of Hepatitis C Virus (HCV) after liver transplant.   "
113156|NCT01804816|"     Acupuncture treatment may improve the cardiac function and the quality of life in heart     failure patients. These effects may be related to the inhibition of sympathetic activity     and/or increased vagal function. The suppression of inflammatory reaction with acupuncture     treatment may also be associated with these outcomes. Specific aims include:        1. To evaluate the effect of acupuncture treatment on human cardiac sympathetic/vagal          activity        2. To evaluate the effect of acupuncture treatment on cardiac function and functional          capacity        3. To evaluate the general health score of the quality-of-life with acupuncture treatment        4. To explore the mechanism of acupuncture treatment on inflammation and nitrative stress          in heart failure patients.   "
113157|NCT01804803|"     The study aims to validate the clinical efficacy of a telemedicine- and web-based system     platform for Self-monitoring of blood glucose (SMBG) data transmission and analysis in terms     of improved metabolic control, assessed by measuring changes in HbA1c, in insulin-treated     diabetic patients. The system platform involves (i.) systematic (real-time and anywhere)     transmission of SMBG data to a decision supported software (DSS)-assisted server, (ii.)     web-based analysis of data, and (iii.) feedback on patients and medical staff to implement     metabolic control. The expected outcome is that using this telemedicine-based system with     transmission of SMBG data, web-based analysis of data and medical feedback to patients and     medical team will improve glucose control in insulin-treated individuals with type 1 or type     2 diabetes mellitus.   "
113158|NCT01804790|"     National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing     neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy     (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.   "
113159|NCT01804777|"     The purpose of this study is to determine with the administration of amiloride, observe an     enhanced natriuresis, reduction in blood pressure and weight compared to the administration     of hydrochlorothiazide in Type 2 Diabetics.   "
113160|NCT01804764|"     Sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high     mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. The Surviving Sepsis     Campaign (SSC) recommends a first 6 hours resuscitative bundle to improve patient's     outcome. Despite this, the bundle is poorly performed, because of a superficial knowledge of     the guidelines and several difficulties in their clinical implementation. In recognition of     this, a sepsis six bundle is designed to facilitate early intervention with just three     diagnostic and three therapeutic steps to be delivered by staff within 1 h.      The aim of our study is to evaluate if an Educational and Organizational Intervention (EOI)     could improve septic patient's outcome in no Critical Care Units. The second endpoint is to     evaluate if the compliance to the sepsis six bundle could improve after this sort of     intervention.   "
113161|NCT01804751|"     The purpose of this study is to build a model for the prediction of adverse perinatal outcome     for preeclampsia in china   "
113162|NCT01804738|"     This study aims to test the following hypothesis in healthy lean young men:        -  There are differences in glycemic response (GR) and insulin response (IR) between          Chinese, Malay and Asian-Indian        -  There are differences in GI values to the same food between ethnic groups        -  There are ethnic differences postprandial GR and IR for high vs low GI foods        -  Mastication, salivary amylase activity, gastric emptying rate and gut microbiota          composition influences inter-individual glycemic and insulinemic variability        -  Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and          gut microbiota composition determines the inter-ethnic glycemic and insulinemic          variability   "
113163|NCT01804725|"     The objective is to study the effects of bicycle riding and bicycle seats on blood flow to a     man's reproductive organs. It has been shown that bicycle riding can affect a man's ability     to have an erection. Each year, newer and better bicycle seats come out but these seats have     not been adequately studied for their effects on blood flow in the genital region.   "
113177|NCT01804543|"     Evaluation of use of ranolazine in patients with stable heart pain with cardiac magnetic     resonance imaging (CMRI) and phosphorous-31 magnetic resonance spectroscopy (31P MRS).     Subsequent testing using these modalities will show improved oxygen to the heart muscle.   "
113165|NCT01804699|"     Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition that may     cause life threatening irregular heart rhythms that often manifest as unexpected cardiac     arrest or sudden death in early adulthood. The condition is difficult to diagnose and often     is not noticed until a family member suffers a cardiac arrest or death.      The Canadian National ARVC registry will collect data from Inherited Heart Rhythm Clinics     across Canada.      STUDY OBJECTIVES:      Primary:        1. To determine the natural history of ARVC (short/intermediate term), including risk of          symptomatic arrhythmias and sudden death, for patients with the phenotype and those gene          positive patients without phenotype evidence of disease.        2. To understand risk factors for sudden death/appropriate ICD use in ARVC, including test          characteristics/performance and their relationship to outcomes (ECG, Holter, signal          averaged ECG, loop recorders, imaging, voltage mapping, T wave alternans, cardiac biopsy          and biomarkers).        3. To establish a phenotype genotype correlation, including comparison of patients with          disease causing mutations, variants of unknown significance (VUS) and Task Force          Criteria (TFC) positive, gene negative patients   "
113166|NCT01804686|"     The purpose of this study is to collect long-term safety and efficacy data for participants     treated with PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for     participants who are currently enrolled in PCI-32765 studies that have been completed     according to the parent protocol, are actively receiving treatment with PCI-32765, and who     continue to benefit from PCI-32765 treatment.   "
113167|NCT01804673|"     The purpose of this study is to evaluate the safety and tolerability of the fentanyl     iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice     for management of acute (a quick and severe form of illness in its early stage) moderate to     severe post-operative pain (pain after surgery) including the comprehensibility and     usefulness of the accompanying information material.   "
113168|NCT01804660|"     This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV     transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal     population. This study is important for establishing a baseline to analyze results obtained     in MS patients (another dedicated study is performed in parallel in MS patients). The study     will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env     protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines     levels will be analysed to define control levels in the normal population and their variation     during one year. The data obtained in this study in healthy controls will be compared to     those obtained in a parallel similar study, GN-E-002, conducted in different types of MS     patients.   "
113169|NCT01804647|"     This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV     transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients.     The study will be conducted over one year in four cohorts of patients with different forms of     MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and     secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who     have suffered a single clinical event but do not comply with diagnosis criteria for definite     MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution     of patients and with the reverse transcriptase activity, inflammatory markers assessed by     cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003,     is performed in parallel and is part of another dedicated protocol).   "
113170|NCT01804634|"     The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical     bone marrow, post-transplant cyclophosphamide and sirolimus is safe and feasible for patients     with very high-risk solids tumors.   "
113171|NCT01804621|"     The purpose of the study is to implement a randomized control trial testing effects of     information scanning on cancer prevention and screening behaviors in a population sample of     50-70 year olds. Participants will receive one of five versions of an e-newsletter once/month     for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.   "
113172|NCT01804608|"     Assess pain, function, trunk and lower limbs kinematic during functional tasks after hip     muscle strengthening versus hip muscle strengthening and sensory motor training in lower     limbs.   "
113173|NCT01804595|"     This is a randomized controlled trial testing the efficacy of 4 sun protection     interventions--education only; education and mailed sunscreen; education and text message     reminders; and education, mailed sunscreen, and text message reminders--among Michigan     Operating Engineers. Pre- and post-intervention surveys will be collected to determine     changes in sunscreen use and sun burning, the primary outcome variables. The investigators     hypothesize that all interventions will increase sunscreen use and reduce burning and that     the education-only intervention will have the least effect of the 4 interventions while the     education, mailed sunscreen, and text messaging arm will have the greatest effect.   "
113174|NCT01804582|"     Family-centered mental health treatment of children values and supports the role of parents     in their child's recovery. However, medications are often the primary focus in community     treatment. Young children, even preschool-age youth, are increasingly being treated with     antipsychotic medication for serious mood and behavior problems. This medication may be     necessary to address safety issues (such as severe aggression), but it can cause serious side     effects, such as obesity. Also, medication-only treatment does not follow recommended care     for these types of problems. Psychosocial treatments (for example, programs that coach and     empower parents to manage their child's difficult behaviors) are highly recommended as part     of comprehensive (medication and psychosocial) child treatment. Parent involvement in     psychosocial treatment has clear benefits for their child's mental health and, unlike     medication, the effects can last long after treatment is completed. However, problems related     to access (for example, long waiting lists) and use (for example, parent mistrust of mental     health services) of services are common. Maryland, like other states, has developed a system     to improve medication safety by reviewing health information about the child to determine if     the treatment is appropriate. This review reduces unnecessary medication treatment and makes     sure that children have adequate health screening before starting any treatment. Children who     are approved for medication treatment have moderate-to-severe mental health problems, which     supports their need for comprehensive (medication and psychosocial)treatment, instead of     medication-only treatment. In this study, investigators are partnering with parents/family     advocates, child-serving agencies, and health providers to develop a Family Navigator Service     to link with this medication program. Family Navigators are individuals who have cared for     their own child with mental illness. The navigators will support parents, provide information     on psychosocial treatment options, and address barriers to using services. The goals of this     program are to improve use of psychosocial services, and to improve parent empowerment,     support, and satisfaction with their child's mental health treatment. The investigators also     expect that the Navigator Service will improve the child's overall mental health and reduce     the likelihood that he/she will need a medication dose increase or another medication added     over the initial treatment period. The Navigator Service will be provided for parents of     public insured children who are 10 years old and have just been approved for antipsychotic     medication treatment. The Navigator Services will be provided by phone, so this service can     support families in both rural and urban settings. The investigators' long term goal is to     develop a Family Navigator program that strongly supports Family-centered treatment of     children and can be used to help families in other underserved areas beyond Maryland.   "
113175|NCT01804569|"     There will be significant differences between control and experimental group after the     moxibustion intervention as to, subjective physical symptoms and quality of life.   "
113179|NCT01804517|"     Headache disorders are prevalent, disabling, under recognized, under diagnosed and under     treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment of     migraine is based on patient education (lifestyle habit modification, trigger avoidance), and     pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a     repartition of tasks between different health professionals.      In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache     Centers, and a headache nurse was judged as an essential component of such centers.      Gaul has reviewed the structured multidisciplinary approach that could be used in a headache     centre and the existing studies using such structures. Five studies did include a headache     nurse. No study did observe the impact of a nurse only. Resources in medical care are     limited. One study did use a program of 96 hours, which does not seem realistic on the     long-term and for a large pool of patients in a public hospital. Patients are not always able     to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do, finding     a specialized therapist for chronic headache is difficult. Defining the role of a nurse and     demonstrating the impact on patient care is therefore a first step in the concept of a     headache center. Possible roles of a headache nurse according to Gaul are patient education,     follow-up of the treatment plan, addressing patient queries, and monitoring of patient     progress. The headache nurse may also participate in research projects. In a hospital     Headache Clinic, the nurse may be involved in intra-venous treatments and blood sampling for     research.      In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking. We     propose to study this aspect prospectively. A study with positive findings would encourage     health ministers to fund and support headache nurses for headache centers across Canada for     headache management. Chronic headache and therefore chronic migraine would be a focus of such     centers, since most patients seen in specialized centers are chronic.      HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM Migraine     Clinic to improve treatment outcome, and reduce the burden of headache. This     multidisciplinary approach will also allow a higher efficiency of the team.   "
113180|NCT01804504|"     The project is aimed at investigating the effect of nutrition education on knowledge,     attitude and practice (KAP)of subjects who are frequently eating out, and the effect on     metabolic parameters.   "
113181|NCT01804491|"     The aim was to investigate with a multi-segmental foot model the kinetic and kinematic in     patients with a hallux rigidus, before and after different type of surgery.   "
113182|NCT01804478|"     SPECIFIC AIMS      The limbs of diabetic patients are associated with decreases in capillary density, arterial     inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing     and viability of tissue, especially in patients with peripheral vascular disease and     diabetes. The investigators hypothesize that mild external compression can restore the     decreases in skin and muscle blood flow and that there would be greater increases in     microvascular blood flow induced by leg compression compared to healthy subjects. Blood flow     will be measured using Photoplethysmography (PPG) before, during, and after external     compression, and muscle oxygenation will be measured with Near Infrared Spectroscopy (NIRS).      The specific aims are:        -  To measure Muscle Blood Flow (MBF), Skin Blood Flow (SBF), and Bone Blood Flow (BBF)          microcirculatory alterations in the leg and foot caused by mild external compression in          healthy subjects and patients with diabetes.        -  To measure muscle oxygenation changes in the leg and foot caused by mild external          compression in healthy subjects and patients with diabetes.        -  To optimize pressures of Continuous Compression to induce maximum microcirculatory blood          flow in healthy subjects and patients with diabetes.        -  To optimize compression pressures, duration, and frequency of Intermittent Pneumatic          Compression (IPC) to induce maximum microcirculatory blood flow in healthy subjects and          patients with diabetes.        -  To measure microcirculatory response to compression in patients with diabetes        -  Continue to validate of photoplethysmography as a tool for measuring microcirculation.   "
113183|NCT01804465|"     The purpose of this study is to find out what effects taking ipilimumab, as an immediate or     delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and     their prostate cancer.   "
113184|NCT01804452|"     The purpose of this study is to evaluate several different tests, including brain imaging,     eye movement testing, body fluid samples, measurements of memory and other thinking     abilities, and measures of functional independence in the hope that this information can be     used to guide diagnosis and treatment of PSP and CBD in the future. Recent advances in our     understanding of the biological causes of these diseases offer hope for new treatments. As     such treatments are developed, sensitive and specific biological measurements (biomarkers)     will be needed to provide precise and direct measures of the state of the brain, which will     improve the statistical power of clinical trials. Brain imaging with Magnetic Resonance     Imaging (MRI) has previously been used to measure disease-related changes in the brain. The     goal of this study is to identify the best methods of analysis (including eye movements,     imaging, and behavioral measures) for tracking PSP and CBD over time. In addition, certain     biomarkers in the blood and cerebrospinal fluid might also be useful for following these     diseases over time. This study will examine the value of blood and CSF biomarkers relative to     brain imaging and functional measures.   "
113185|NCT01804439|"     Cardiovascular disease (CVD) is an important public health problem that affects millions of     people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or     hypertension, and prevalent CVD are well documented. However, few studies have investigated     associations with onset of disease. The initial manifestation of CVD, for example an episode     of unstable angina, is important because it influences the prognosis, the quality of life and     the management of disease. Furthermore, the extent to which social deprivation, alcohol     consumption or atrial fibrillation affects presentation of CVD is poorly understood and     deserves further consideration.      Most previous studies have considered CVD as a single entity. However, differences in     aetiology between coronary phenotypes suggest that risk factors may not be shared across     specific coronary phenotypes and their relative importance is likely to differ for each     phenotype. Gaining knowledge of these differences could provide insights into the     pathophysiology of specific forms of CVD and could eventually lead to modification of     recommendations for patient management and disease prevention.      We propose to use the linkage of the national registry of coronary events to general practice     records in the Clinical Practice Research Database (CPRD), to investigate whether     demographic, behavioral, and clinico-metabolic risk factors differentially influence the     onset of specific types of CVD.   "
113218|NCT01804010|"     1. To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active          metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine          at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for          4.5 days at the same doses twice daily versus placebo and to use the study results for          bridging with Caucasian data.        2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on          heart rate after single and then after repeated administrations.        3. Clinical safety of ivabradine versus placebo.   "
113186|NCT01804426|"     Post-traumatic stress disorder, PTSD, is one of the most prevalent psychiatric disorders.      As casualties of motor vehicle accidents, criminal acts or terrorism are arriving to the ER,     it is almost impossible to conclude who will overcome his psychiatric trauma and will be able     to return to his normal life course and who will be thrown out of his promising life     trajectory.      Current attempts to identify those who are at the greatest risk are still unsatisfactory,     which comprise a therapeutic dilemma, since the interventions used to ameliorate and prevent     the occurrence of PTSD in a high-risk patient, might be counter-productive and even     precipitate the emergence of PTSD in lower-risk patients.      Since PTSD is closely related to the Fight, Flight or Freeze reaction, it has much to do     with the autonomic nervous system and the major stress hormone, cortisol. Despite many     studies demonstrating the involvement of those factors in the development of PTSD, various     attempts to profile the direction of the association between PTSD and cortisol abnormalities     have yielded conflicting results.      The introduction of a novel method of assessing the excretion of cortisol using residues in     the human hair shaft, has allowed an unprecedented evaluation of its activity over a     prolonged period of time.      Using this novel method of cortisol assessment, the investigators aim to identify biomarkers     that will be able to aid in the prediction of PTSD development ahead of symptoms emergence,     and will enhance the understanding of the physiological mechanism involved and etiology of     this disorder.   "
113187|NCT01804413|"     Hypothesis:      Pegvisomant combined with the glucagon stimulation test (GST) can improve the accuracy of     this test when used to diagnose adult GH and cortisol (steroid hormone)insufficiency.      Study aims:      Diagnosing GH and cortisol deficiency in adults requires a special test. At present, the     insulin tolerance test (ITT) is considered the test of choice. However, this test is     difficult to perform as it involves giving insulin through the veins to decrease blood sugars     to very low levels, and this can be unpleasant, and cannot be performed in elderly adults and     in those with a history of heart disease, seizure disorders or stroke. For this reason there     is an urgent need for an alternative reliable test. At present, the GST is considered the     alternative test to the ITT but its accuracy in obese patients and in those with diabetes     remains unclear. Pegvisomant is a medication that can increase GH production in the body. The     purpose of this study is to find out if combining pegvisomant with the GST can help improve     the accuracy of this test so that it is comparable with the ITT in diagnosing adult GH and     cortisol insufficiency.      Study design:      Subjects will be recruited from the Oregon Health & Science University Dynamic Endocrine     Testing Unit. A written informed consent will be obtained and a screening interview will be     carried out. During the screening interview, the study will be explained to the subject in     detail. For women of child-bearing age, a pregnancy test will be performed. The subjects will     then take part in three studies on separate days: (1) GST; (2) pegvisomant (1 mg/kg)     injection into the abdomen 3 days before the glucagon stimulation test (ii) insulin tolerance     test. For the GST, glucagon will be injected into the muscle and blood draws will be     performed every 30 mins for 240 mins. For the insulin tolerance test, a blood draw will be     performed and insulin will be given into the vein followed by blood draws every 15 mins for     120 mins. The data from all three studies will be analyzed in the study where the peak growth     hormone and cortisol levels for all three tests will be compared. A questionnaire will be     used at the end of the study for the subjects to rank the level of preference of the three     tests. The data of the study will be analyzed using a computer statistical program where the     identity of the subjects will be coded to maintain confidentiality.   "
113188|NCT01804400|"     This study will assess the safety and efficacy of QAW039 alone and in combination with     Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure     chamber.   "
113189|NCT01804387|"     Lamivudine had been widely used for treatment-naïve chronic hepatitis B patients. However,     development of antiviral resistance has been known as the major drawback: Incidence of     lamivudine resistance was reported to be approximately 70% after 5 years (Lok AS et al,     2003). For the treatment of lamivudine resistance, adefovir has been widely used (Lok AS and     McMahon B, 2009). However, switching to adefovir monotherapy was also reported to be at high     risk of resistance, 25% at year 2 (Yeon JE et al, 2006). Recently, adding adefovir on     lamivudine was shown to be superior to switching to adefovir monotherapy by decreasing the     adefovir resistance (Rapti I et al, 2007, Lampertico P et al, 2007). However, combination of     adefovir and lamivudine does not increase antiviral activity compared with adefovir     monotherapy in patients with lamivudine resistance (Peters MG et al, 2004). As many patients     are still viremic with the treatment of lamivudine and adefovir over 1 year, the     investigators need more potent combination of the drugs. Telbivudine is a new nucleoside     analogue with potent antiviral activity. The previous phase III study has shown the     superiority of telbivudine over lamivudine in HBeAg positive and negative subjects (Lai CL et     al, 2007). Therefore, telbivudine plus adefovir may be a better treatment option than     lamivudine plus adefovir for the lamivudine-resistant chronic hepatitis B patients. No study     assessing the efficacy of telbivudine plus adefovir has been conducted for these patients.     The aim of this study is to evaluate the safety and efficacy of telbivudine plus adefovir     compared with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patients     at the end of 1 year follow-up,   "
113190|NCT01804374|"     This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed     after first or further line treatments. In this trial, all patients will be treated until     progression or unacceptable toxicity with sorafenib and everolimus. The treatment with     sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression     of the disease after 6 months from study entry.   "
113191|NCT01804361|"     The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the     patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.   "
113192|NCT01804348|"     Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard     procedure, using pooling test and/or sterile speculum examination and /or pH test, and     AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic     fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of     presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as     observed by the patient and the clinician (positive/negative).   "
113193|NCT01804335|"     The goal of this clinical research study is to learn if CD5789 is safe and tolerable when     given to patients with early stage CTCL.      CD5789 is designed to attach to tumor cells and change their genetic material. This may stop     the growth of the tumor cells.   "
113282|NCT01803165|"     In this investigation, the investigators will attempt to demonstrate that patients who have     received nerve blocks (regional anesthesia) prior to open surgical vascular bypass of the     lower extremities (infrainguinal bypass grafting) will have improved surgical outcomes namely     a reduction in the rates of death, wound infection, graft thrombosis, graft revision, and     amputation. As well, the investigators anticipate that patients who have undergone regional     anesthesia for infrainguinal bypass grafting will have improved secondary outcomes with     respect to a decreased length of stay, narcotic consumption, nausea and vomiting,     post-operative cognitive dysfunction, major cardiac events, post-operative pain, and     hyperglycemic episodes.   "
113194|NCT01804322|"     Epilepsy requires long-term drug treatment and is frequently associated with other clinical     conditions. Combinations of antiepileptic drugs and other compounds are fairly common and     increase with age. Adverse drug reactions and drug interactions are expected and may affect     compliance, particularly in patients not receiving adequate information. Primary objective of     the study is to verify if a comprehensive and standardized educational plan is followed by a     significant reduction of the number of adult patients with epilepsy and comorbidity     presenting clinically relevant adverse treatment effects. Secondary objectives include     effects on number of adverse treatment events, health-related quality of life (HRQOL), direct     medical costs, and patient's compliance. The study is a randomized, controlled, open-label,     pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent clinical     conditions on chronic treatment and at least one clinically relevant treatment-related     adverse event and/or clinically relevant drug interaction. Eligible patients will be     randomized to receive a comprehensive and standardized educational plan (experimental arm) or     to usual care, ie management of adverse event/drug interaction as done in clinical practice     (control arm). The experimental plan consists in discussing with patient and caregiver the     cause and nature of adverse event/drug interaction, the tolerability profile of each drug,     the clinical manifestations associated with current drug interaction(s), contraindications of     potentially interfering over-the-counter drugs, indications and benefits of suggested     treatment changes, and withdrawal of potentially interfering, contraindicated or ineffective     drugs. All patients will be seen at one, three and six months after admission.      Expected results: The number of patients free from clinically relevant adverse treatment     events and/or drug interactions in each treatment arm at end of study is expected to be     higher in patients assigned to comprehensive and standardized educational plan compared to     usual care (primary outcome). Patients on the experimental plan are also expected to be more     commonly free from relevant adverse events and/or drug interactions at each intermediate     visit, to present a lower number of adverse treatment events, to imply lower costs for     medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to     present less weekly treatment omissions.   "
113195|NCT01804309|"     Regional lymph node status is the most important prognostic factor for disease-free and     overall survival in breast cancer. Accurate nodal staging can be achieved only by surgery.     Today, in early-stage invasive breast cancers with clinically negative lymph nodes, minimally     invasive sentinel lymph node biopsy (SLNB) is considered the gold standard of regional lymph     node staging. To optimize the effectiveness of SLNB, precise pre-and intraoperative mapping     of lymphatic drainage is important. The (SLNB) technique is not standardized. The most common     and most accurate way of lymphatic mapping is performed with the combined application of a     gamma-emitting isotope labeled substance and blue dye, the so-called double labeling     technique. Functional lymphatic drainage of SLNB double staining in the mammary gland, skin     and axilla present a number of uncertainties.      According to the axillary, lateral thoracic and thoracodorsal veins, Ibusuki et al. divided     the axillary region into four subregions: brachial (lateral), pectoral (anterior), central     and subscapular (posterior) zones. They revealed clear relationship between the anatomic     location and status of the SLN, also confirmed by Gallowitsch et al. SLN was detected in     Level I in 96% and in Level II in 4% by SPECT/CT.      Knowedge of relationships between the drainage of sentinel lymph node staining into the     axillary subregions, location of the primary tumor, tumor size, SLN positivity and its     location within the subregion are of particular importance in the decision making whether or     not axillary lymphadenectomy (ALND) needs to be performed.      In the prospective randomized phase 3 trial by Giuliano et al. (ACOSOG Z-11) ALND was not     performed in early breast cancer patients with clinically negative axilla and     breast-conserving surgery, for 1-2 macroscopically positive SLNs (10). After an average     follow-up of 6.3 years, data were compared to the traditional ALND group and no difference     was detected in 5-year overall survival or disease-free survival at 5 years.      Aims of the investigation:      To examine the location of SLN in the axillary subregion (anterior, posterior, central,     lateral, apical) in patients with early breast cancer (T <5 cm).      To statistically assess correlations between the location, size, histological parameters of     primary breast tumor and the subregion of the SLN.      To statistically assess SLN positivity and its location within the sbregion.      To statistically assess subregional localisation of positive SLN and the number of all     positive regional lymph nodes, to predict a limited number of cases with lymph node     metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be     omitted.   "
113196|NCT01804296|"     This research proposal aims to better understand the neurobiology of depression in     adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically     impact brain function and mood. This investigation also proposes the first study to examine     the efficacy of rTMS maintenance therapy in adolescents who have met clinical criteria     following acute rTMS treatment. The magnetic resonance (MR) spectroscopy pattern of rTMS     response will be analyzed according to previously established protocols.   "
113197|NCT01804283|"     1. Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in          patients undergoing double valve replacement (aortic and mitral).        2. The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest          may be rescued by ischemic postconditioning.        3. Downstream effectors would also be affected.   "
113198|NCT01804270|"     This research proposal aims to better understand the neurobiology of depression in     adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically     impact brain function and mood. This study will be the first to use a randomized,     double-blinded, sham-controlled approach to the investigation of rTMS therapy for depressed     adolescents. This approach will allow for the validation of rTMS treatment outcomes in the     depressed adolescent population in a scientifically rigorous manner. The magnetic resonance     (MR) spectroscopy pattern of rTMS response will be analyzed according to previously     established protocols.   "
113199|NCT01804257|"     Feasibility study of using a digital health feedback system (DHFS) to monitor     medication-taking and physiologic and behavioral parameters in patients with bipolar disorder     or schizophrenia. Hypothesis: Using a digital health feedback system to characterize     medication-taking behavior and activities of daily living is safe and tolerable in     appropriately selected patients with bipolar disorder and schizophrenia.   "
113200|NCT01804244|"     The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a     single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed     conditions in healthy Japanese adult male participants.   "
113201|NCT01804231|"     Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical     management of men with suspected recurrent prostate cancer post prostatectomy or     radiotherapy.      We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and     will lead to changes in management decisions among men being re-staged for suspected prostate     cancer recurrence post-surgery or radiation who are potentially eligible for local salvage     therapy.   "
113202|NCT01804218|"     The purpose of this study is to test the hypothesis that 18—22 week treatment with the     inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma,     compared to placebo.   "
113203|NCT01804205|"     The purpose of this study is to evaluate the effects of MgSO4 administration on the     pharmacodynamics of rocuronium in patients with 60 or more years of age.   "
113217|NCT01804023|"     The purpose of this study is to compare tests of vaginal insertion of applicators(visual     inspection of returned applicators (VIRA), inspection of returned applicators under     ultraviolet (UV) light, and DNA/protein markers) to determine which, if any, warrant use in a     clinical trial of a new vaginal microbicide. The study will also determine whether indicators     of semen can be detected on applicators and the degree to which they correlate with reported     intercourse, and the correlation between vaginal bacteria detected by a vaginal swab and     those detected from the applicator. In addition, the study will determine whether several     factors that may be encountered in a clinical trial are likely to affect detection of these     markers, including storage for 30 days vs. 7 days, wiping applicators after use, the presence     of gel, and inter- and intra-woman variability. The study will also assess safety.   "
113204|NCT01804192|"     Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the     body has a balanced ying-yang or the qi flows in correct strength and quality along the     meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in     the channels and is able to regulate and restore yin-yang balance.However, there are some     drawbacks associated with acupuncture which may limit its applications. These include     transmission of infectious disease, pneumothorax and other problems associated with organ     punctures, cardiac tamponade, and broken needles with remnants migrating to other     locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is     effective in reducing dyspnoea in patients with chronic obstructive pulmonary     disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor     pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy     subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works     still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4)     and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the     subject could experience distinct sensation as deqi.   "
113205|NCT01804179|"     There are two parts to this study: (1) an information gathering phase leading to the     development of new educational materials; and (2) a study to test the newly developed     material. The information gathering phase has been completed. The purpose of this part of the     research study is to test the usefulness and acceptability of new educational materials     investigators have developed. Investigators will compare the new educational material to     another widely available educational brochure. The goal is to see if the new educational     material will change knowledge and behaviors about colorectal cancer and colorectal     screening.   "
113206|NCT01804166|"     This study is designed to collect tissue samples from the biopsy specimen that was used to     diagnose HSTCL and, if possible, to obtain a single blood sample, a buccal swab sample and a     bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In     addition, demographic and clinical patient information will be collected. The study will be     conducted in North America. The study population will include IBD patients in North America     with HSTCL who are identified through the sponsor's adverse event reporting systems. Cases of     HSTCL will be identified through postmarketing adverse event reporting (eg, spontaneous     reports, reports from late phase clinical trials, reports from patient registries) or from     the sponsor's new or ongoing clinical trials. Eligible for enrollment are male or female     patients of any age who have a confirmed diagnosis of HSTCL. There is no study-related     therapeutic intervention and this protocol will not restrict or introduce any therapeutic     interventions, including medications. All patients will continue to be managed by their     personal physicians. No healthy subjects will be enrolled in this study.   "
113207|NCT01804153|"     Evaluate the feasability and security of the autologous ASC for the femenine stress urinary     incontinence   "
113208|NCT01804140|"     This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into     clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and     analyzed from eligible patients with solid tumors (other than metastatic melanoma or     papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as     defined by this screening protocol will have potential access to the separate vemurafenib     protocol MO28072.   "
113209|NCT01804127|"     The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse     large B-cell lymphoma based on the interim results of PET/CT.   "
113210|NCT01804114|"     The primary endpoint of this study will determine if subjects receiving a continuous infusion     of local anesthetic following laparoscopic ventral hernia repair, with the pain pump     installed as described to treat post surgical pain will have a lower incidence of pain than     those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this     study will determine if subjects receiving a continuous infusion of local anesthetic     following laparoscopic ventral hernia repair, with the pain pump installed as described to     treat post surgical pain will have a lower utilization of narcotic analgesic medication than     those patients treated with the placebo, saline-filled pain pump.   "
113211|NCT01804101|"     This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating     patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in     chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading.   "
113212|NCT01804088|"     The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the     Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of     the iliac arteries.   "
113213|NCT01804075|"     Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter     duration of opiate medication treatment and fewer infants treated with a second drug.   "
113214|NCT01804062|"     The purpose of this study is to meet the respiration rate accuracy specifications for the     study pulse oximeter monitoring system (study device)in a healthy volunteer population when     compared to established technologies for measuring parameters related to respiration, such as     Capnograph Respiration Rate (RR) (CO2).   "
113215|NCT01804049|"     Sarcopenia is the loss of muscle mass, strength and function with aging and is associated     with increased disability, falls and fractures. Older adults with diabetes and prediabetes     are insulin resistant and have a higher risk of developing sarcopenia. This study examines     the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in     older adults with prediabetes.   "
113216|NCT01804036|"     This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is     more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also     investigate whether MBB is additionally beneficial for co-morbid conditions such as stress,     PTSD, depression, etc, compared with that of Zolpidem.   "
113312|NCT01802775|"     This study is a randomized, open-label, blinded endpoint, parallel-group, active-control,     multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD),     designed to assess the safety and potential efficacy of adding edoxaban to aspirin following     femoropopliteal endovascular intervention, with or without stent placement, relative to     current treatment practice with clopidogrel and aspirin.   "
113219|NCT01803997|"     The purpose of the study is to evaluate an afterschool program to teach nutrition through     basic cooking skills. This after school extracurricular program increases the students'     confidence, knowledge, and skills for cooking as one of the first steps for dietary     improvement. In addition to the life lessons students learn during this class, they gain     self-confidence and become self-sufficient culinary experts that are capable of educating     their siblings, parents, and social circles. This research project will test the impact this     program has on nutritional knowledge, culinary efficacy, and nutritional choices made in and     out of the home. The Pink and Dude Chef Afterschool Cooking Program was developed through     STRIDE (Science through Translational Research in Diet and Exercise at California Polytechnic     state University (Cal Poly) in San Luis Obispo, CA.      Hypothesis: Middle school students participating in the Pink and Dude Chef afterschool     cooking program will increase nutritional knowledge, culinary efficacy, motivation to eat     fruits and vegetables, and fruit and vegetable intake compared to an attention control group.   "
113220|NCT01803984|"     Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder     that has long believed to have no severe consequences. Recent evidence, however, strongly     suggest that migraine is associated with increased risk of ischemic stroke and there is     initial evidence that migraine is associated with structural brain changes independent of the     occurrence of stroke.      As migraine has strong links with the vascular system, it is plausible that vascular     functions interact on the association between migraine and structural brain changes as well     as cognition.      Our primary objectives are to investigate: (i) the relationship of migraine and migraine     subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active     migraine; (ii) the relationship of migraine on cognitive performance among patients with     active migraine; and (iii) the relationship of migraine and migraine specifics with vascular     functions and morbidity. As secondary objective, we investigate whether the association of     migraine on structural brain changes or cognitive performance is modified by vascular     functions.      This will be an observational study conducted in the Headache Center in Bordeaux. 300     patients have to be included (150 patients with migraine with aura and 150 patients with     migraine without aura).      Inclusion criteria are: all patients with a clearly defined migraine (as per     IHS[International Headache Classification] criteria) who are aged 30 and older, are able to     fluently speak French, and who are willing to participate.      Exclusion criteria are: pregnant woman and patient who have a major psychiatric disease or     major anxiety disorder or had a pacemaker (which would not allow to perform a MRI imaging).      The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for     the Assessment of Neuropsychological Status (RBANS). In addition to the RBANS, we will use     the HIT-6 (Headache Impact Test) and MIDAS (MIgraine Disability ASessment) and the depression     scale CES-D (Center for Epidemiologic Studies Depression Scale).      Vascular risk status will be assessed by measurement of blood pressure and reports of     vascular risk factors. The endothelial function will be measured with a noninvasive     Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device (Itamar Medical     Inc, Framingham, MA).      For crude comparisons, chi-square tests will be used for categorical variables and t-test for     continuous variables. Multivariable-multinominal modeling techniques will be utilized for the     comparisons adjusting for potential confounding variables. All statistical tests will be     two-tailed and a P <0.05 will be considered statistically significant.   "
113221|NCT01803971|"     the international recommendations don't explain the place of the intraosseous infusion in the     reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the     delay for obtaining a vascular access by evaluation of a current strategy (using intraosseous     infusion after one peripheral venous access failure) and to determine the potential failure     risk factors of venous access.   "
113222|NCT01803958|"     This study was designed and developed in the Emilia Romania research and innovation program     (PRI ER). The study does not have commercial sponsors and comes under the independent studies     provided for by Ministerial Decree 17.12.2005. The PRI ER program will guarantee a     contribution to the study for the first three years of recruitment through the regional     Innovation Fund, to cover the costs of coordination and data management sustained by the     Coordinating Center.      Primary Objectives The study proposes to evaluate whether partial hypofractionated and     accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer     with low risk of local recurrence and who undergo conservative surgery, is not inferior to     postoperative irradiation with conventional fractionation of the entire breast as regards     local control (incidence of ipsilateral recurrences as prime event).      Secondary Objectives Comparison of the global survivals, freedom from locoregional     recurrences (with exception for contralateral tumors and second tumors), distant relapse-free     (except for local or regional relapses or in the contralateral breast) in patients treated     with conventional radiotherapy and accelerated partial radiation.      To evaluate whether accelerated partial irradiation offers cosmetic results, acute toxicity     comparable with conventional irradiation.      Possible connection with other national and international studies Similar studies which     nonetheless evaluate different methods of partial irradiation are currently underway.      Study Design Multicenter phase III controlled randomized, unblinded study of non-inferiority.      Number of cases Recruitment of 3302 patients is planned. Target Population of the Study Women     aged = > 49, ECOG 0-2, undergoing conservative breast surgery for invasive breast cancer, pT     1-2 (< 3 cm in diameter) pN0-N1 M0, unifocal, resection margins histologically negative (³ 2     mm) at first intervention or after subsequent widening.      Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is     planned and a follow-up period of 5 years for an overall duration of the study of 13 years.      Treatment      The patients will be randomized to receive one of the following treatments:      Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval     of at least 6 hours between the two fractions, for five consecutive working days.      Control arm 50.0 Gy in 25 fractions (2 Gy per fraction), once a day for 5 days in the week.      Endpoints Primary: survival free of local ipsilateral recurrence as prime event Secondary:     global survival, locoregional recurrence-free, distant recurrence-free, acute and late     toxicity (RTOG) and cosmetic result.      Evaluation and Follow-Up Program Controls are planned during the radiotherapy, at the end of     treatment, at 6 weeks, 3-6-12 months from the end of the radiotherapy and then once a year     until the end of 5 years.      Data Analysis Partial irradiation will be considered not inferior to the standard irradiation     if the top extreme of the HR confidence interval at 95% (to endpoint) does not exceed the     established value of 1.5 The study was sized in relation to the rate of local ipsilateral     breast recurrences as prime event at 5 years and assuming that this rate in the standard     treatment group is 4%, accepting as maximum Hazard Ratio inferior to 1.5 and error a and b     equal respectively to 0.05 and 0.10 and test at an endpoint.      The survivals will be calculated using the Kaplan-Meier method. The hazard ratio (HR) will be     calculated using the Cox model and its confidence interval at 95% will be reported.      Ethical Aspects and Informed Consent For participation in the study an informed consent is     planned appropriately drawn up and submitted to the approval of the Ethics Committees.      The clinical study will be carried out according to the ethical principles of the Helsinki     Declaration, the GCP guidelines, the Italian laws and regulatory activities for carrying out     clinical studies.      Before formal commencement of the study its approval/sole opinion by the reference Ethics     Committee of the proposing group is stipulated. The individual investigators of the different     participating institutions are directly responsible for the submission for approval of the     protocol by their Ethics Committees.   "
113223|NCT01803945|"     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of     orally administered AVE8112 in patients with Parkinson's Disease (PD).   "
113224|NCT01803932|"     Cluster randomized controlled trial to evaluate a male-focused primary prevention programme     which used a men's only group discussion format to prevent intimate partner violence against     women & girls through fostering knowledge and behaviour changes by: (1) increasing men's     knowledge on the impact of violence against women; (2) promoting gender equitable     beliefs/behaviours within relationships; and (3) developing anger management techniques.   "
113225|NCT01803919|"     The purpose of this trial is to make a comparison between the use of antiseptic silver     alloy-coated silicone urinary catheters and the use of conventional silicone urinary     catheters in spinal cord injured patients to prevent urinary infections.   "
113226|NCT01803906|"     The investigators are studying patients with undefined mitochondrial diseases to identify     genetic mutations in nuclear or mitochondrial Deoxyribonucleic Acid (DNA). Most patients with     suspected or known mitochondrial diseases have no genetic confirmation. The investigators     expect that evaluating tissue samples from patients with mitochondrial disorders will lead us     to discover mutations in new or known genes causing mitochondrial dysfunction.   "
113227|NCT01803893|"     PIF: biomarker of successful implantation To overcome the poor reproductive potential of     embryos generated during in vitro fertilization cycles and the lack of markers enabling the     identification of the most competent ones, it is common to transfer multiple embryos. However     this practice is associated with the risks of multi-fetal pregnancies and high     morbidity/mortality. Ideally, the availability of a marker specifically produced by viable     embryos would permit the transfer of a single embryo (SET) without affecting the chances of     pregnancy and, most importantly, capable to drastically reduce multiple pregnancies after     IVF. In preliminary work, we demonstrated that no pregnancy resulted following the transfer     of embryos where PIF was undetectable in culture media.(Keramitsoglou, T et al. ASRI Meeting,     Hamburg, 2012) Using a non-invasive method of detection of PIF in the media surrounding the     embryo will be correlated to live birth following single embryo transfer. By selecting only     viable embryos, it will reduce the need for multiple IVF cycles, increase the rate of     pregnancy outcome associated with SET, and will minimize multi-fetal pregnancy that has very     high medical and societal costs both in pregnancy and after delivery.   "
113228|NCT01803880|"     The purpose of this study is to evaluate changes in clinical and imaging outcomes following     arthroscopic treatment of a single medial femoral chondral lesion plus partial medial     meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥     eighteen (18) years of age.   "
113229|NCT01803867|"     This is a Phase I, multi-center, double-blind, randomized, placebo-controlled,     dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and     immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all     clinical presentations of MS.   "
113283|NCT01803152|"     The use of adjuvant vaccination with autologous dendritic cells (DC) matured in situ after     being loaded with tumor lysates derived from autologous refractory sarcoma tissue will be     safe, feasible and potentially beneficial for patients diagnosed with sarcoma. This     vaccination will result in evidence of immune stimulation against tumor antigens. In     addition, combining myeloid derived supressor cells (MDSC) inhibition using gemcitabine with     DC vaccination in this method will be safe and feasible and show improved immune parameters     over DC vaccination without MDSC inhibition.   "
113230|NCT01803854|"     The Gulf War Era Cohort and Biorepository pilot project collected epidemiological, survey,     clinical, and environmental exposure data from Veterans who served during the 1990-1991 Gulf     War Era. Approved researchers will be able to use these data and the blood samples to do     future research about the health of Gulf War Era Veterans.      During the pilot, the recruitment response rate and processes were assessed. The results     revealed several opportunities for improvement. For this reason, CSP 585 research activities     transitioned to a qualitative phase to focus more on the Veteran voice. In this stage,     research staff spoke with Gulf War Era Veterans through focus groups, interviews, and other     activities such as events and meetings to learn more about Veterans' experiences and/or ideas     on this and other Gulf War research projects. This phase provided new information that can     help researchers create better recruitment processes for future projects involving Gulf War     Era Veterans.      For more information on CSP 585, please contact Kristina Felder at 919-286-0411 ext. 7379 or     Kristina.Felder@va.gov.   "
113231|NCT01803841|"     The aim of this registry is to analyze several factors affecting the procedural success and     clinical outcomes at 1 year of follow-up according to the approach site.   "
113232|NCT01803828|"     Pathophysiology of diabetic cardiomyopathy (DCM) is yet unclear and gender differences at     baseline and a specific treatment have not been indicated. The investigators already     demonstrated the positive impact of phosphodiesterase type 5A (PDE5A) inhibition in men. The     investigators' study aims to characterize DCM, measuring molecular and neuroendocrine     assessment to relate to intramyocardial metabolism and cardiac kinetic. The investigators     will perform a randomized, placebo-controlled, double-blind study enrolling 164 diabetic     patients (females and males) with DCM, to evaluate gender responses to 6 months of PDE5A     inhibitors (PDE5Ai). The investigators' study will describe gender differences in DCM     features. The proposed research will test whether PDE5Ai could become a new target for     antiremodeling drugs and to discover a molecular pathways affected by this class of drugs and     a network of circulating markers for the early diagnosis, monitoring and prediction of     response to treatment of DCM.   "
113233|NCT01803815|"     This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients     and their pattern of antihypertensive drugs consumption. The investigators also aimed to     investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood     pressure control rates in these patients. Additionally, the investigators were also     interested in trying to understand if the control of OSA may be influenced by the use of     different classes of anti-hypertensive drugs.   "
113234|NCT01803802|"     This study is designed to help us better understand the factors that affect the sexual lives     of women who have been sexually mistreated during childhood. With this study we hope to learn     about factors that may be promising targets for future treatments of sexual problems related     to past sexual experiences. The investigators hypothesize that women who have experienced     early sexual abuse are more likely to have sexual problems in adulthood than women who were     not abuse in childhood.   "
113235|NCT01803789|"     Metacarpal V fractures are injuries of the upper extremities. They occur frequently,     primarily in young adults.These fractures are caused by falling on the fist, sports accidents     and direct or indirect forces.      Surgical intervention is necessary for fractures with a strong palmar angulation of the     metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline     recommendations decisions about therapy are made taking into account logistical aspects,     available hardware, individual expertise and preferences. The objective of the study is to     compare the advantages and disadvantages of single versus double Kirschner wires for     intramedullary fixation of metacarpal V fractures in order to standardize national therapy     procedures.      Primary hypothesis:      In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck     fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with     a double Kirschner wire with regard to the functional outcome after 6 month, as measured with     the Disabilities of the Arm, Shoulder and Hands Score (DASH).   "
113236|NCT01803776|"     The Physical Activity and Nutrition in Children (PANIC) Study is a single-centre physical     activity and diet intervention study that provides novel scientific information on physical     activity, nutrition, overweight, obesity, physical fitness, cognition, oral health, sleep,     pain and other aspects of quality of life as well as health care costs in a population sample     of children and adolescents. The main hypothesis of the study is that regular physical     activity and dietary changes improve health and quality of life among children and     adolescents.   "
113237|NCT01803763|"     The aim of this study is to investigate the pathophysiological mechanism of omalizumab in     patients with documented chronic urticaria who have complaints under standard antihistamine     treatment. With this study the investigators will assess the correlation between Fc-IgE     receptor downregulation as well as functionality and clinical response to omalizumab     treatment in patients with chronic urticaria. This may be an approach for other diseases as     well, where Fc-IgE receptor crosslinking are essential. The treatment time is set for a total     of 4 monthly applications of omalizumab. According to the dosage recommendations of recent     studies, fixed doses of 300 mg omalizumab are administered subcutaneously.   "
113238|NCT01803750|"     The purpose of this study is to understand primary care provider's knowledge, attitudes, and     barriers to promoting evidence-based cancer screening and prevention practices for physicians     with large Latino patient populations. The investigators will ask providers information on     cancer screening and prevention practices by conducting one-on-one interviews. In addition,     they would like to develop a committee of community providers to help design and implement     cancer screening and prevention programs specifically for Latino patients based on the     interview findings.   "
113239|NCT01803737|"     The purpose of this study is to examine the feasibility of a campaign intervention for weight     management compared to a standard behavioral weight loss intervention in overweight and obese     adults.   "
113284|NCT01803139|"     Women diagnosed with an early stage cancer of the breast usually have the cancer removed by     lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators     published the result of a multicentre study showing that breast Intensity Modulated Radiation     Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the     investigators will recall all patients at 8 years to assess if this technique also reduces     permanent side effects including pain and cosmesis.   "
113240|NCT01803724|"     The Irritable Bowel Syndrome (IBS) is a frequent disease, affecting between 10 and 20% of     general population. Several pathophysiologic mechanisms have been described in IBS, among     them the role of intestinal microbiota and small intestinal bacterial overgrowth (SIBO) have     received special attention. SIBO has an adequate response to antibiotic treatment,     unfortunately it didn't have an adequate diagnostic test: The classic gold standard -jejunal     aspirate culture- has been criticized due to lack of standardization; the breath tests are     simpler and widely available, but they have also been criticized due to inadequate diagnostic     accuracy for SIBO. For this reason seems important to evaluate the performance of breath     tests in terms of predicting clinical benefit of antibiotic therapy in IBS patients, rather     than predicting a positive culture and SIBO.      The objectives of this study are:        1. Determine which breath test (lactulose or glucose) predicts better a potential clinical          benefit of antibiotic treatment (Rifaximin) in IBS patients.        2. Determine which of the multiples diagnostic criteria described for the lactulose breath          test predicts better a potential clinical benefit Rifaximin in IBS patients.   "
113241|NCT01803711|"     To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine     (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety     symptoms in patients with select medical conditions (cancer, cardiovascular diseases and     diabetes).   "
113242|NCT01803698|"     Background The Institute of Medicine (IOM) published guidelines in 2009 for optimal     gestational weight gain (GWG) during pregnancy. These guidelines include trajectories for     optimal GWG, based on a woman's pre-pregnancy body mass index (BMI), to be used throughout     the duration of a pregnancy. Although there is a significant association between the total     GWG recommended by these guidelines and maternal and perinatal outcomes, research has     demonstrated that only approximately one-third of pregnant women have total GWG within the     recommended amounts. Factors known to influence GWG include maternal age, parity, being in a     committed relationship and smoking. In addition, recommendations by primary care providers     have been shown to influence actual GWG. Women appreciate advice from their primary care     providers, however, despite this, there is evidence that many patients report not being     advised at all about GWG by their primary care providers.      Relevance Excess weight gain in pregnancy has been shown to be a modifiable risk factor for     excess weight in childhood, thus contributing to the intergenerational cycle of obesity.     There is an opportunity to interfere with this cycle during the peri-pregnancy period, as     women's motivation to engage in behaviour change is elevated and contact with their primary     care providers is frequent.      Research Question and Hypothesis What impact does training family physicians to regularly     refer to the IOM trajectories and provide feedback about GWG (training in the use of IOM     charts) during routine prenatal visits, compared to usual care, have on congruence of total     GWG with IOM guidelines? Null Hypothesis: there is no difference in the congruence of total     GWG with IOM guidelines between women whose family physicians were assigned to training in     the use of the IOM charts and those whose family physicians were assigned to usual care.      Objectives      The following are the objectives for this study:        1. To compare the congruence of total GWG with IOM guidelines between women whose family          physicians were assigned to training in the use of IOM trajectories and those whose          family physicians were assigned to usual care.        2. To explore the relationship between other independent variables (maternal age, parity,          committed relationship and smoking) and congruence of total GWG with IOM guidelines, for          women whose family physicians were assigned to training in the use of IOM trajectories          and for those whose family physicians were assigned to usual care.   "
113243|NCT01803685|"     This register study will collect the treatment information of the intracranial arteriovenous     malformation patients in China. We aim to understand the current treatment situation of the     disease in China.   "
113244|NCT01803672|"     Background.There is some evidence that engaging in regular moderate-intensity physical     activity may help ameliorate cancer-related fatigue experienced by childhood cancer     survivors, which eventually improve their quality of life. Nevertheless, there is growing     concern about declining levels of physical activity in childhood cancer survivors.      Purposes. To examine the effectiveness of an integrated adventure-based training and health     education programme in promoting the adoption and maintenance of regular physical activity,     reducing fatigue and improving the quality of life among Hong Kong Chinese childhood cancer     survivors.      Design and Subjects. A randomised controlled trial (RCT), two-group pre-test and repeated     post-test, between subjects design was conducted. Recruitment of subjects was carried out     through the Sunshine Parents Club, which is a non-profit voluntary organization with the aim     to provide education and psychological support to parents of Hong Kong Chinese childhood     cancer survivors.      Intervention. Participants in the placebo control group received an amount of time and     attention (leisure activities organized by a community centre) that mimicked that received by     the experimental group. Participants in the experimental group joined a four-day integrated     adventure-based training and health education programme, which contained education talks, a     workshop and adventure-based training activities.   "
113245|NCT01803659|"     The purpose of this pilot study is to determine whether breast milk retinol concentration     increases in response to daily supplementation with small amounts of vitamin A (~600 ug     RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary     purpose is to evaluate sampling methods for collecting breast milk samples in a community     setting. The results of this pilot study will allow us to determine whether milk retinol is a     useful indicator for evaluating the impact of food-based interventions on the vitamin A     status of lactating women.   "
113246|NCT01803646|"     The purpose of this research study is to test the safety and effectiveness of the study drug,     AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an     injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with     tinnitus can take part in the study, if their tinnitus started within the last 3 months.   "
113247|NCT01803633|"     Phase 2 of this study involves determining how consumption of cheese compared with a     non-dairy cheese substitute influences inflammation over a six hour period.   "
113248|NCT01803607|"     The purpose of this study is to assess to what extent sequential treatment with odanacatib     results in incremental gains in bone mineral density (BMD) over time in female participants     who have received at least 3 years of bisphosphonate therapy. It was hypothesized that     odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.   "
113249|NCT01803594|"     This study involves measuring subject's blood lipid responses after they consume a mixture of     dietary fats of marine and dairy origin and vitamin supplements mixed into a milkshake, on     three separate days. The investigators hope to learn more about how different food     ingredients influence the metabolism HDL in individuals with low blood levels of HDL     cholesterol.   "
113250|NCT01803581|"     The purpose of this study is to compare the efficacy and safety of an insecticide-free head     lice product with that of a pyrethrum-based product.   "
113285|NCT01803126|"     Biofilm has been identified as the major bacterial phenotype contributing to atherosclerosis.     It has become very important to evaluate atherosclerosis and the role of biofilm using     advanced technologies. It is also important to understand wound biofilm at a genetic and a     molecular level.   "
113286|NCT01803113|"     The objective of this field study is to demonstrate the clinical performance of the Sofia hCG     FIA Test, using urine specimens from females of childbearing age.   "
113251|NCT01803568|"     Normal glucose uptake and metabolism in skeletal muscles are essential to keep blood glucose     within normal range and hence, insulin resistance (possibly mediated by inflammatory     processes) in skeletal muscle is a major pathogenic factor in type 2 diabetes. Physical     activity seems to be of essential importance in the prevention and treatment of type 2     diabetes. Myokines are proteins secreted from skeletal muscle that can execute important     biological functions locally in the muscle (paracrine) or in other organs like the brain,     heart and pancreas (endocrine). Evidence suggest that several interleukines and other     cytokines are secreted by skeletal muscles. In the present project, the investigators will     explore the relation between secreted myokines from muscle cells, insulin resistance and     glucose metabolism before and after 12 weeks of exercise intervention. Subjects with normal     as well as impaired glucose metabolism will be included in the study.   "
113252|NCT01803555|"     The primary objective of the study is to establish whether budesonide/formoterol fumarate     dihydrate (BF) SPIROMAX 160/4.5 mcg is as effective as SYMBICORT TURBOHALER 200/6 mcg     administered twice daily in patients with persistent asthma.   "
113253|NCT01803542|"     The purpose of this institutional protocol is to offer SBRT to selected patients in a     controlled environment to refine treatment techniques (including dose/fractionation     schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some     institutions and the available data suggest that it can be used safely and with good results.     This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours     in the lung and how often people have side effects. Radiation therapy is usually given once a     day, often for a few weeks. In this study, study participants will receive high doses of     radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of     about 1 to 2 weeks.      Several reports indicate that this therapy might shrink tumours and control the cancer for     extended periods of time. Although specialists started to treat patients with SBRT over 10     years ago, it is still used in relatively few cancer centres.   "
113254|NCT01803529|"     Studies show that chest pain is a common complaint presented in both general practice and in     emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies     about treatment of chest pain from the intercostal muscles were found by search in medical     literature databases. The purpose of this study is to evaluate the effect of two different     physical therapy interventions on intercostal pain in patients with stable heart disease.      The hypothesis was that deep friction massage combined with heat-pack is more effective than     heat-pack only.   "
113255|NCT01803516|"     The purpose of this study is to see how the look of telangiectasias (small dilated blood     vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's     overall well being.      Patients will have a set of treatments with a pulsed dye laser. This is a laser that targets     red blood vessels and delivers heat causing the telangiectasias to become smaller and less     visible. The laser has been used safely to treat telangiectasias on the skin of patients who     received radiation for breast cancer.      Patients in the study will be asked to complete a questionnaire asking how they feel about     the telangiectasias, their radiated skin and its effect on their daily lives. The     questionnaire will be given at every visit. The improvement in the look of patients' radiated     skin will also be compared to answers to the questionnaire. We hope the study will improve     our understanding of how patients feel about the long term effects of radiation on their     skin.   "
113256|NCT01803503|"     This study aims to find out whether the effect of docetaxel chemotherapy may be improved by     combining it with another anti-cancer drug called sunitinib, which stops blood vessels from     growing (anti-angiogenic agent). Sunitinib is an oral anti-angiogenic drug that has been     approved for the treatment of kidney cancer, a rare form of soft tissue tumor called     gastrointestinal stromal tumor, and a rare form of cancer in the pancreas called pancreatic     neuroendocrine tumor. Sunitinib is usually given continuously at a dose of 37.5mg (3 pills)     daily either alone or in combination with chemotherapy. However, there are studies which have     shown that the continuous administration of sunitinib may reduce chemotherapy effectiveness.     On the other hand, a short course of sunitinib before each chemotherapy cycle may sensitize     the tumor to chemotherapy. This treatment strategy will be used in patients with different     kinds of cancers with a commonly used chemotherapy drug, docetaxel. Ths study aims to     evaluate if intermittent administration of low dose sunitinib before docetaxel chemotherapy     can improve the treatment response in cancer patients.      Study Hypothesis: Low dose, short course sunitinib at 12.5mg daily orally for 1 week prior to     chemotherapy can normalize tumor vasculature and enhance delivery of chemotherapy into the     tumor, and improve treatment response and progression-free survival.   "
113257|NCT01803490|"     Closed suction drains are commonly used following surgery, if the wound is expected to     discharge significant amounts of fluid. To this date, no evidence base exists as to the exact     post operative time period or discharge volume necessitating presence of a drain. In     orthopedic common practice, drains are removed on the second post operative day, fearing the     drain will serve as a point of entry for nosocomial infection. In this study, drains will be     left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of     days following surgery. Daily cultures and antibiotic levels will be taken from the drains     receptacle, to determine if and when the drains is colonized by aerobic bacteria.   "
113258|NCT01803477|"     The purpose of this study is to determine if the new vehicle formulations containing ingenol     mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation)     when applied to AK lesions on the forearm for two consecutive days.   "
113259|NCT01803464|"     Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000     individuals in the U.S. An estimated 70-80% of these individuals have spasticity which     affects ambulation and requires management. Therefore, the treatment of spasticity is a     primary goal of interventions for children with CP. One treatment widely used to reduce     spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no     studies have determined the effect of Botox treatment on bone in humans. Also, a low     intensity vibration treatment has been shown to improve bone structure in the lower extremity     bones of children with CP. The aims of this study are: 1) to determine the effect of Botox     treatment in conjunction with a daily vibration treatment on bone mass and bone structure in     children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox     and vibration on bone.   "
113260|NCT01803451|"     The overall goal of this project is to understand the mechanisms by which gastric bypass     surgery improves glucose metabolism.      The central hypothesis guiding this project is that the reconfiguration of intestinal transit     with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins     that improve insulin secretion and glucose metabolism. The study is divided into three     specific aims.        1. To determine the role of incretin hormones on insulin secretion in patients with gastric          bypass surgery using intravenous-oral hyperglycemic clamp.        2. To compare incretin effect and glucose tolerance among patient who suffer from          hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.        3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.   "
113261|NCT01803438|"     The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI)     performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line     therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial     fibrillation (AF).   "
113262|NCT01803425|"     This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy     infants and children of the local population as per the licensing requirement of the Sri     Lankan regulatory authority.   "
113263|NCT01803412|"     This is a phase III, multicenter, open-label, uncontrolled extension study in male subjects     with DMD open to eligible US and Canadian subjects who previously participated in the     following studies of drisapersen: DMD114876, DMD114044 and DMD114349. Subjects will receive     6mg/kg subcutaneous drisapersen on a weekly basis. For subjects who have previously     experienced significant safety or tolerability issues or who experience these during the     study, there is the potential of an alternate intermittent dosing arm that will be given as a     regimen of 6 mg/kg weekly for 8 weeks followed by 4 weeks off treatment. For subjects who     experience or have previously experienced significant safety/tolerability issues, side     effects or reactions or intermittent dosing, intravenous dosing will be made available.   "
113264|NCT01803399|"     This is a randomized, partially-blinded, placebo and moxifloxacin-controlled, single dose,     4-period, balanced crossover study. The primary objective of this study is to separately     assess the effects of a therapeutic and supratherapeutic dose of GSK1322322 on the cardiac     conduction (corrected QT interval [QTc]) compared with placebo in eligible healthy male and     female subjects. Avelox (moxifloxacin hydrochloride) will be used as an open-label positive     control in order to validate the sensitivity of the study in detecting QTc change.     Approximately 56 healthy subjects will participate in the study for approximately 9 weeks     i.e. 30 day Screening period, 4-week Treatment period, and a 7-10 day Follow-up period. There     will be 4 treatment periods separated by at least 1 week. Subjects will be admitted to the     clinical unit on Day -1 of each dosing period. Each subject will receive each of the four     treatment sequences (GSK1322322 1200 milligram [mg] intravenous [IV] over 60 minutes x 1     dose, GSK1322322 3000 mg IV over 60 minutes x 1 dose, GSK1322322 Placebo IV over 60 minutes x     1 dose, moxifloxacin 400 mg administered orally x 1 dose) on Day 1 of each Treatment period     in a randomized fashion. Twelve-lead electrocardiogram (ECG), continuous Holter monitoring,     laboratory tests, vital sign measurements, and serial pharmacokinetic samples will be     collected for up to 24 hours following each treatment. If no clinically significant     abnormalities are noted, subjects will be discharged from the clinical research unit after     the completion of all assessments on Day 2 in each period and return approximately one week     later for the next dosing period. Each individual subject will follow the same dosing     schedule at every period. A Follow-up visit will be conducted 7-10 days after administration     of the last dose of study medication in treatment period 4.   "
113265|NCT01803386|"     The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device and     study its reliability and ability to differentiate ALS patients from healthy controls.   "
113266|NCT01803373|"     The purpose of this study is to test the relative bioavailability (extent and rate to which a     drug is taken up by the body) of TMC207 following the administration of two pediatric     formulations of TMC207 taken with and without food in healthy adult participants.   "
113267|NCT01803360|"     The purpose of this study is to determine whether neridronate is effective in the treatment     of pain related to bone marrow oedema in patients with osteoarthritis of the knee.   "
113268|NCT01803347|"     Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery   "
113269|NCT01803334|"     This is a study looking at patient's satisfaction with incision site and location after     undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have     the anticipated incision marked with a washable marker on their abdomen. The control group     will have preoperative counselling as usual. After surgery, will assess patient's     satisfaction with the incision scar.   "
113270|NCT01803321|"     This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo     controlled, pediatric study conducted in three phases.   "
113271|NCT01803308|"     The purpose of this study is to compare the safety and tolerability of ascending doses of SB     9200 given for up to 14 days to subjects with chronic Hepatitis C infection.   "
113272|NCT01803295|"     In the proposed study the investigators aim to evaluate the effect of the standard of care     dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low     risk recurrent NMIBC lesions and to compare our findings to instillation with the standard     mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed     with TC-3 gel will have at least non-inferior and even superior results over the standard     instillation mode      The investigators believe that this study is of importance of several aspects:        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the          current instillation mode.        2. If proved effective this mode of treatment might save the need of TURBT performance and          serve as a new mode of tumor ablation.        3. Even if proved partially effective this mode of treatment will diminish tumors size or          number thus enable a more limited TURBT procedure.        4. This mode of treatment will enable immediate medical attendance to the patient's tumor          recurrence without the waiting period (resulting from queues in the medical centers) for          TURBT, which might improve the patient's prognostic outcome.        5. If this experimental treatment will prove to have a better ablative effect, this could          be translated to a better prophylactic effect of tumor recurrence.   "
113298|NCT01802957|"     This study will introduce a multi-faceted intervention package which will be implemented in     the newly developed network of St. Paul's Hospital Millennium Medical College (St. Paul) and     the surrounding seven satellite health centers. The goal is to assess if this group of     interventions improve the skills and confidence of providers to handle obstetric emergencies,     if they streamline the referral process and if they result in improved maternal/newborn     health outcomes.   "
113273|NCT01803282|"     This is an open-label, multicenter, sequential dose-escalation, and expansion study to     evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of andecaliximab     (formerly GS-5745) alone and in combination with chemotherapy.      The study consists of 2 parts (Parts A and B). Participants can only qualify for and     participate in 1 part.      Part A is a sequential dose escalation to determine the maximum tolerated dose of     andecaliximab in participants with advanced solid tumors that are refractory to or intolerant     to standard therapy or for which no standard therapy exists. In Part A, participants will     receive andecaliximab only. Part A will consist of between 12 to 48 participants.      Part B is a dose expansion to obtain additional safety and tolerability data for     andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma,     lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast     cancer. In Part B, participants will receive andecaliximab in combination with     standard-of-care chemotherapy. Part B will consist of between 115 to 295 participants.      Please note the study is currently only recruiting in the breast cancer cohorts.   "
113274|NCT01803269|"     This randomized phase II trial studies how well giving topotecan hydrochloride or     cyclodextrin-based polymer-camptothecin CRLX101 works in treating patients with recurrent     small cell lung cancer. Drugs used in chemotherapy, such as topotecan hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Cyclodextrin-based polymer-camptothecin CRLX101 may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know     whether topotecan hydrochloride is more effective than cyclodextrin-based     polymer-camptothecin CRLX101 in treating patients with lung cancer.   "
113275|NCT01803256|"     The full body marker sets that are typically used in opto-electronic 3D gait analyses either     disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of     this study is to identify the possibilities and limitations of an enhanced trunk marker set     for the measurement of spine dynamics during gait in adolescents with and without structural     spine deformities.      It has been hypothesized that the enhance trunk marker set:        1. is a valid method for the measurement of spine deformations in the sagittal, frontal and          indirectly transverse planes.        2. is an applicable and reliable method for the measurement of spine dynamics during gait          in healthy adolescents and in patients with structural deformities such as seen in          scoliosis.        3. is sensitive enough to distinguish the spinal movement pattern during gait measured in          scoliosis patients from the one measured in healthy adolescents.      To verify the hypotheses, the following measurements will be carried out:        -  Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients.        -  Instrumented gait analysis with a standard full body marker set and the enhanced trunk          marker set in scoliosis patients and healthy controls.   "
113276|NCT01803243|"     Measuring spine dynamics is a necessity in order to better understand gait deviations     throughout the whole body and to evaluate treatment effects on spinal movement during gait.     However, the full body marker sets that are typically used in opto-electronic 3D gait     analyses either disregard the spine entirely or regard it as a rigid structure. Therefore,     the purpose of this study is to use an enhanced trunk marker set in order to evaluate the     biomechanical effects of lower extremity treatments on spine dynamics in patients with     different pathologies.      It has been hypothesized that        1. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics          during gait in patients with deviations occurring secondary to leg length inequality.        2. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics          during gait in patients that present both primary and secondary deviations such as seen          in hemiplegic and diplegic cerebral palsy.        3. treatment by means of either a shoe insole or a modified shoe with sole lift on the          shorter side has an effect on spine dynamics during gait in patients with leg length          inequality.        4. treatment by means of an ankle foot orthosis to control the foot position has an effect          on spine dynamics during gait in patients with hemiplegic and diplegic cerebral palsy.      To verify the hypotheses, instrumented gait analyses with a standard full body marker set and     the enhanced trunk marker set will be carried out before and immediately after an orthotic     lower extremity treatment in the respective patient group.   "
113277|NCT01803230|"     Creatine supplementation may improve cognitive function in elderly and vegetarian     individuals. This study aims to investigate the role of creatine supplementation on cognitive     function in healthy children.   "
113278|NCT01803217|"     Unnecessary right ventricular pacing has been shown to be detrimental in recipients of     implantable pacemaker or defibrillators.      The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms     (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right     ventricular pacing.   "
113279|NCT01803204|"     To evaluate the effectiveness in the use of an educational material through: Assessment of     knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the     survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management     of postoperative signs and symptoms   "
113280|NCT01803191|"     The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic     bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of     fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose     of ciprofloxacin 500 mg 1 hour before biopsy.   "
113281|NCT01803178|"     The main aim of the study is to investigate, in humans, the effect of plant sterols on     vascular function by measuring flow-mediated dilation (FMD).      This study also aims to study the effect of plant sterols on pulse wave velocity (PWV),     aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP),     blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on     z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will     be assessed.      For all study outcomes, effect sizes and 95% confidence intervals will be estimated.      Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly     increase FMD.   "
113309|NCT01802814|"     The main goal of this study is to improve the outcome of children and adolescents with     standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a     large international study group platform allowing for optimization of standard treatment     strategies and integration of new agents.   "
113287|NCT01803100|"     Overall Aim: To describe and to assess the change in the temporal profile and transmission of     microorganisms between patients and environmental surfaces after admission into a newly     disinfected room.      Study Activities: Investigators will prospectively and concurrently perform microbiological     sampling of body sites (nose, throat, axillae, perineal and wounds) high touch surfaces (e.g.     bedside rail, bed surface, toilet seat, IV pump and tray table) for consented adult patients     admitted to freshly cleaned patient rooms. The microbiological sampling of body sites is     already performed in many units of the hospital as standard of care. Infection and     readmission related data from enrolled patients will be collected for upto 1 year after     enrollment.      Data analysis: Standard surveillance for hospital-acquired infections will be performed by     the infection control group of the hospital. The identity and the nature of micro-organisms     colonizing the high touch surfaces of rooms and of patient's body sites will be determined     and compared. Risks involved is no more than minimal risk.   "
113288|NCT01803087|"     This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active     metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with     and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP     pMDI plus formoterol pMDI licensed products; this will be additionally compared to the     systemic exposure in adults without the spacer device.   "
113289|NCT01803074|"     The primary purpose of this study is to study the safety and tolerability of a HIV drug and     to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected     patients   "
113290|NCT01803061|"     Patient-reported information on outcomes such as symptom-burden and health-related quality of     life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer     research. However, integrating patient-reported information in the routine clinical practice     is often difficult due to excessive time use and practical barriers. Electronic data     acquisitions, where the treating physician has immediately access to the patient-reported     data in the subsequent consultation, have been shown to be beneficial in the everyday     clinical decision making.      The aim of this study is to develop and test a computer-based patient-reported assessment     tool that will assist the clinicians in tracking long term and late effects in head and neck     cancer patients and investigate if the tool leads to improved symptom assessment of a range     of head and neck cancer specific symptoms, which again may lead to improved symptom control     and enhanced quality of life in the patients.      Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics     at Herlev Hospital and physicians and nurses who work at the clinic will be invited to     participate. The assessment tool will be developed with inspiration from prior international     studies of symptom assessment in head and neck cancer patients and tailored so that it will     fit into a Danish context. The tool will be tested in a controlled intervention study. In the     intervention group, patients will complete the assessment tool in the patients waiting area     prior to every scheduled consultation. The result will then be printed and provided to the     treating physician. In the control group, the patients will complete the assessment tool     prior to consultations. However, the data will not be provided to the physicians at any time.      To assess the impact of the tool on number of symptoms addressed during consultations and     patients' overall quality of life, medical records will be reviewed for before start of     intervention and again at 6 and 12 months follow-up. The patients will also complete the     EORTC QLQ-C30 and the EORTC QLQ-H&N35 at baseline and at 6 and 12 months follow-up.     Furthermore, we will conduct a qualitative evaluation (semi structured interview and     participant observations) of attitudes among clinicians and patients regarding the use of     tool at the point of care.   "
113291|NCT01803048|"     Abnormalities in structural and functional connectivity between brain regions have been     suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant     contributors to neuropsychological functioning and injury outcome. The purpose of this study     is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted     imaging (DWI) and resting state functional MRI to compare structural and functional     connectivity between individuals with documented mild TBI and healthy controls. To evaluate     the significance of structural and functional connectivity for behavior, the brain imaging     data will then be related to measures of cognition and emotion. Over a 4-year period, 150     adults with documented mild TBI and 30 healthy controls will participate in the study.      The study will investigate the following questions and hypotheses:        1. Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter          integrity across multiple stages of recovery following mild TBI relative to healthy          controls. It is hypothesized that mild TBI will be associated with greater white matter          abnormalities than healthy controls.        2. It is hypothesized that there will be a relationship between FA, cognition and emotion          as a function of the injury.        3. It is hypothesized that functional connectivity will be related to FA.   "
113292|NCT01803035|"     The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in     terms of clinical and microbiological response in treatment of impetigo.   "
113293|NCT01803022|"     The study purpose is to document the prescription and the use of Low Molecular Weight Heparin     in usual medical practice in patients with cancer and established Venous Thromboembolism.     This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin     therapy of Venous Thromboembolism in patients with cancer.   "
113294|NCT01803009|"     Little is known about the impact of risk assessment tools on decision-making by patients and     clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one     of the most prominent risk assessment tools available, no study has quantified its usability     or impact on decision-making or uptake of screening. In this study, we will measure patients'     satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its     impact on their decision-making and behavior. In addition, we will assess the impact of     adding information about their chance of having an advanced adenoma.   "
113295|NCT01802996|"     This purpose of this study is to evaluate the evaluate the efficacy of Magnesium     Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute     liver injury.   "
113296|NCT01802983|"     The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to     prolongation of intensive and mortality. It is reported that the mortality rates have varied     between 20% and 100%, depending on number, severity, duration, type and combination, and     definition of dysfunction. In our study, the investigators explore some comprehensive     treatment technology to improved outcomes of MODS patients.   "
113297|NCT01802970|"     To determine the safety of administering anakinra plus the physician's chemotherapy choice     (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic     breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in     patients who undergo IL-1 receptor blockade.   "
113310|NCT01802801|"     The purpose of this study is to determine the intra- and interobserver agreement.   "
113311|NCT01802788|"     Further assess the performance and safety profile of the commercially available Portico Valve     implanted, using the Delivery System and the Loading System, in patients with severe     symptomatic aortic stenosis.   "
113299|NCT01802944|"     Following their deployment to the 1991 Gulf War, many veterans (GWV) reported a constellation     of unexplained health symptoms; common among them were attention and memory difficulties,     fatigue, joint pain, headaches, gastrointestinal complaints, and mood and sleep problems.     Despite the passage of time, the symptom complex persists for many veterans. Indeed, it is     estimated that at least 25 percent of GWV (nearly 170,000 veterans) have a persistent form of     chronic multisymptom illness (CMI). GW deployed veterans are also developing significantly     more chronic diseases such as diabetes, hypertension, arthritis, and coronary heart disease     than their non-deployed veteran peers putting these individuals at risk for accelerated     aging-related diseases of the peripheral and central nervous system (CNS). Recent studies     have shown a slowing of response speed that affects mental flexibility across multiple     cognitive domains (memory, attention, visuospatial functions) especially on tests that were     timed and computerized and where small differences in cognitive reaction times could be     measured. Recent studies also have suggested that the response inhibition deficits shown in     GWV may reflect executive system dysfunction as reflected by slower motor responses across     multiple cognitive domains.      To date, there are no treatments that have been shown to improve the health or cognitive     difficulties of GW veterans; thus there is an urgent need to establish effective, safe, and     tolerable treatments for GW CMI. Previous studies in other cognitive disorders have found     that intranasal insulin improves memory, attention, and mood, reduces neuroinflammation, and     modulates cortisol levels; it has also been identified as a treatment that has the capacity     to alter many of the leading problems of GW CMI.      During this study there are 2 treatment groups and a placebo group that will last for 8     weeks. The treatment groups will self-administer their designated dosage of insulin through a     nasal pump twice a day, while the placebo group will administer saline through a nasal pump     twice a day. These doses have been shown to be effective and safe. The primary outcome     measure will assess improvements in verbal delayed memory using a specific list learning task     and on a measure of selective attention. The study will assess improvements in overall     physical health and mood by asking the participants to complete self report questionnaires.     Neuroendocrine measures will also be obtained in order to evaluate changes in glucose,     insulin, and cortisol levels and examine their impact on GW CMI.      Intranasal insulin has shown great promise in improving memory, attention, and mood in both     older adults with cognitive impairment as well as normal subjects. Thus, this proposal could     prove intranasal insulin to be an effective, safe, and affordable therapy for these ailing     veterans.   "
113300|NCT01802931|"     The study will determine the effect of 400 mg once daily of ketoconazole at steady state on     the pharmacokinetics of a single oral dose of GSK239512 in young healthy volunteers.     Ketoconazole is a strong inhibitor of CYP3A4, which is involved in metabolism of drugs. A     two-cohort design will be applied with cohort 1 aimed at providing a first estimate of the     interaction potential of GSK239512 and ketoconazole in terms of pharmacokinetic parameters in     a small number of subjects. Data from Cohort 1 will inform the decision of which dose to use     in Cohort 2, in which a larger number of subjects will be exposed to GSK239512 without and     with ketoconazole. The target maximum exposure is aimed to be similar to the exposure by a     single dose of 80 mcg of GSK239512 without CYP3A4 inhibition. In summary, the results from     this study will help to estimate the maximum increase in exposure of GSK239512 during     concomitant use of strong CYP3A4 inhibitors and will help define the subsequent dosing     strategy around GSK239512 and co-medications with potential to inhibit CYP3A4.   "
113301|NCT01802918|"     GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the     treatment of chronic HIV infection. This study is the first administration of GSK2838232 in     humans to establish the initial safety, tolerability, and pharmacokinetic profile following     single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on     GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1,     approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose     visit. There will be four dosing sessions for each subject with subjects randomized to     receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be     enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four     dosing sessions for each subject with subjects randomized to receive placebo in a random     sequence.   "
113302|NCT01802905|"     Most systemic therapies are chosen on the basis of large randomized clinical trials; however,     tumour heterogeneity means that cancers with similar histological features may have     substantially different underlying biological drivers. The investigators propose that     applying personal genomic information prospectively obtained in a clinically realistic     timeframe to assist in chemotherapy decision-making could result in more effective and     efficient cancer treatment. This study will investigate this approach in a cross section of     advanced cancers to examine timeliness, deliverability, rate of actionable targets     identified, and our ability to expand this approach into a larger clinical trial setting.   "
113303|NCT01802892|"     The present study aims to evaluate the impact of 5 days oral administration of ronacaleret     100 miligram (mg) and 400 mg on changes in circulating CD34+ cells, when ronacaleret is     followed by the administration of a single dose of plerixafor in healthy human volunteers.      This single centre adaptive design study will be carried out in 2 parts. The part A will     evaluate the change in peripheral circulating CD34+ cells in response to two different 5 day     regimens of ronacaleret (100 mg or 400 mg once daily), given in conjunction with a single     dose of plerixafor (0.24 mg/kilogram [kg]) sub-cutaneously (SC) on the evening of the final     days dosing approximately 12 hours before collection of CD34+ cells on day 6. Subjects (5     each) will be assigned to either one of the ronacaleret arms, in an open fashion. Comparisons     will be made in the change from baseline to end of treatment peripheral CD34+ cell counts.     Part A will be conducted in two cohorts with 5 subjects being enrolled into each of the 2     treatment arms making up the first cohort. Cohort 2 will involve up to 5 further subjects     being enrolled into each treatment arm.      The structure of part B will be finalized following a review of data generated in part A.      The total study duration of Part A for each subject including the screening, treatment and     follow-up periods will be approximately 7 weeks.   "
113304|NCT01802879|"     The study allows continued use of single agent panobinostat in patients who are on single     agent panobinostat treatment in a Novartis-sponsored study which has met its endpoint and are     benefiting from the treatment as judged by the investigator.   "
113305|NCT01802866|"     The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the     rate of progression of geographic atrophy compared to placebo in subjects with dry     age-related macular degeneration.   "
113306|NCT01802853|"     This open-label, randomized, 2-way crossover study will assess the absolute bioavailability     and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to     one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B)     RO6811135, with a washout period of at least 7 days between dosing.   "
113307|NCT01802840|"     The aim of this study is to examine the effects of soy fiber on body weight, body composition     and blood lipids in overweight and obese participants.   "
113308|NCT01802827|"     To investigate the clinical course and risk factors for VAT and the impact of VAT on     Intensive Care Unit (ICU) morbidity and mortality.   "
113314|NCT01802749|"     Bevacizumab has been found to prolong progression free survival in first line, and more     recently, in second line treatment for platinum sensitive ovarian cancer patients who had not     received prior treatment with bevacizumab.      Recently reported data suggest that patients with colon cancer who receive bevacizumab in     more than one line of therapy (beyond progression) have better results. In ovarian cancer,     the role of bevacizumab administered in both first and second-line therapies needs to be     defined.      This study aims to evaluate whether administering bevacizumab in combination with     chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have     received first-line bevacizumab will be more effective than chemotherapy alone.   "
113315|NCT01802736|"     Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and     transmitted mainly through sexual intercourse between an HIV infected and uninfected person.     Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa.     in the general population, Alcohol consumption is associated with increased sexual     transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors     and HIV disease progression among HIV infected persons, the persons able to transmit HIV are     lacking in this setting.      Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons,     assess associations between alcohol and CD4 cell count as well as evaluate the effect of     alcohol motivational intervention counseling on alcohol consumption and the subsequent     practice of risky sexual behaviors, among HIV infected persons.      Methodology: Using both cross-sectional and longitudinal methods,persons living with HIV/AIDS     (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be recruited,     baseline alcohol consumption evaluated, and eligible subjects reporting alcohol consumption     will be randomized to receive either Standard positive prevention counseling alone or in     addition to alcohol motivation intervention counseling. Sexual risk behaviors and alcohol     consumption will be evaluated at 3 and 6 months and compared between randomization arms.   "
113316|NCT01802723|"     Dose Ranging Study   "
113317|NCT01802710|"     Functional dyspepsia (FD)is defined as the presence of symptoms thought to originate in the     gastroduodenal region with no evidence of structural disease that is likely to explain the     symptoms. The cause of this condition is unclear, not being a recognized treatment for it.     The conventional treatments for those patients are symptom based. Unfortunately, these     medications are not very effective. Patients with FD report poorer health status, mental     health, and social functioning than patients with structural gastrointestinal pathology. Our     aim is to compare a combined intervention (medical plus psychological intervention) versus     conventional intervention (medical intervention)in regard to the health related quality of     life, symptomatology, anxiety and depression of those patients. The investigators     hypothesized that compared with conventional intervention a combined intervention would yield     significantly better short (after treatment) and medium term (six months after treatment)     improvement of health related quality of life and symptoms.   "
113318|NCT01802697|"     This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme     Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).   "
113319|NCT01802684|"     Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a     continuous administration of chemotherapy until progression, in order to decrease the risk of     severe toxicities.   "
113320|NCT01802671|"     The objective of this study is to investigate the short- and long-term efficacy of a     Cognitive Behavioural Treatment program for chronic low back pain supported by information     and communication technologies   "
113321|NCT01802658|"     Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time     to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.      Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion     of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and     architectural disorganization. These phenomena occur in the first weeks of development of     spinal cord injury and predominate in the distal femur and proximal tibia. From the third     year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the     initial bone mass, the new equilibrium.      No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to     assess this risk. There is an association between bone mineral density and fracture risk. The     fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in     the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to     perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.   "
113322|NCT01802645|"     The aim of this study is to investigate the following schedules for efficacy with regard to     response rate in neoadjuvant treatment of patients with non-resectable liver metastases:        -  Cetuximab/FOLFOXIRI and cetuximab/FOLFIRI in patients with ras wild type tumours and        -  Bevacizumab/FOLFOXIRI and FOLFOXIRI in patients with ras mutant tumours.   "
113323|NCT01802632|"     This study will treat patients with advanced NSCLC who have already received at least one     course of specific anti-cancer treatment but the tumour has started to re-grow following that     treatment. This is the first time this drug has ever been tested in patients, and so it will     help to understand what type of side effects may occur with the drug treatment, it will     measure the levels of drug in the body, it will also measure the anti-cancer activity. By     using these pieces of information together the best dose of this drug to use in further     clinical trials will be selected.   "
113324|NCT01802619|"     Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free     haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion     of nitric oxide (NO) during and after the surgical procedure on CPB may protect against     endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging.   "
113325|NCT01802606|"     The investigators conducted the study in 4 teaching hospitals and 2 non-teaching hospitals of     Shaanxi Province. Surgeons, clinical pharmacists and nurses took part in patient collection,     information registration, protocol performance.      The investigators recruited 1200 patients with inguinal hernia undergoing inguinal     hernioplasty in the six hospitals from January 2010 to July 2011. The patients were randomly     allocated into control group, cefazolin group and levofloxacin group, with digital meter     method , 400 in each group. The data such as age, sex, case number, length of hospital stay,     antibiotic usage, post-operative infection, infection site, bacterial culture were filled in     self-designed forms on computer.   "
113328|NCT01802567|"     The purpose of this study is to test the feasibility (ability to be done) of experimental     technologies to determine a tumor's molecular makeup (gene expression profile) and mutations.     This technology called the Pediatric Gene Analysis Platform includes a genomic report (gene     expression profile) and a DNA Mutation Panel Report that are being used to discover new ways     to understand cancers and potentially predict the best treatments for patients with cancer in     the future.   "
113329|NCT01802554|"     Cardiovascular disease and depression are some of the most costly illnesses to society, and     caring for a loved-one with Alzheimer's disease has been associated with increased risk for     both depression and cardiovascular disease. Indeed, depressive symptoms have been linked with     elevated plasma concentrations of D-dimer and Interleukin-6 (IL-6), both of which are     associated with increased risk for cardiovascular disease (CVD). The present research tests a     brief behavioral intervention for reducing both depressive symptoms and CVD biomarkers in     Alzheimer caregivers. We hypothesize that caregivers receiving a brief Behavioral Activation     (BA) therapy will show greater reductions in depressive symptoms and in CVD biomarkers     relative to those randomized to a time-equivalent Information and Support (IS) therapy.   "
113330|NCT01802541|"     Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol     levels and reduce body fat. The investigators hypothesize that replacing dietary fat with     diacylglycerol oil reduces excess body fat in type 2 diabetic patients and that     diacylglycerol oil has a beneficial effect on cardiovascular risk factors in Chinese type 2     diabetic patients.   "
113331|NCT01802528|"     Obturator externus (OE) muscle has the possibility as a pain generator, considering its     anatomical and functional aspects, but this muscle as a possible target for therapeutic     intervention is currently understudied in pain practice.   "
113332|NCT01802515|"     The main goal of this study is to evaluate the safety and tolerability of 40 or 80 mg     atomoxetine as a treatment for cocaine dependence. The Phase I studies summarized above     support the safety of atomoxetine in combination with stimulants. As the next step, the     investigators will evaluate the safety and tolerability of atomoxetine in a small clinical     trial with cocaine users. If atomoxetine is found to be promising in this study and     sufficiently powered, double-blind, placebo-controlled studies will be proposed.   "
113333|NCT01802502|"     Tuberculous (TB) meningitis is the most severe manifestation of TB infection, leaving up to     50% of patients dead or neurologically disabled. Current treatment is similar to treatment of     lung TB, although penetration of some antibiotics into the brain is poor and the     immune-pathology of TB meningitis is very different from pulmonary TB. In a recent phase II     clinical trial from the investigators group, the first of its kind globally, intensified     antibiotic treatment, with moxifloxacin and high dose rifampicin, strongly reduced mortality     of TB meningitis.      The investigators aim to examine the effect of intensified antibiotic treatment on mortality     and morbidity of TB meningitis in a phase 3 clinical trial, preceded with an explorative     pharmacokinetic (PK) study to examine if higher oral doses rifampicin result in exposures     similar to the i.v. dose used in our phase 2 trial, since oral rifampicin could be     implemented much easier in low-resource settings.   "
113334|NCT01802489|"     Optic neuritis (ON) is a common event in Multiple Sclerosis (MS), and causes significant loss     of nerve cells in the eye, resulting in poor vision. Optic neuritis also provides a sensitive     way of testing the effectiveness of drugs that may help protect from loss of nerve cells in     ON and therefore in MS.      The investigators have identified through laboratory and early clinical research in humans     that amiloride (a water tablet already in use) may be a drug that can be of benefit in optic     neuritis by protecting from loss of nerves cells, ie a neuroprotective drug.      The purpose of this study is to assess the efficacy of amiloride as a neuroprotective drug in     optic neuritis   "
113335|NCT01802476|"     The purpose of this study is to determine approximately what percentage of an orally     administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic     circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg     oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of     PD-0332991 administered as a 4-hour infusion.   "
113336|NCT01802463|"     Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when     compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in     flow velocities in the retrobulbar arteries in what appears to be related to the degree of     the glaucomatous disease.      The anatomic pathway of the several arteries into the eye is intricately complicate, with at     least one of them (the central retina artery) penetrating the optic nerve before entering the     eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by     a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central     nervous system, this central retinal artery has also to cross this CSF containing     compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial     pressure at the orbital level - the possibility exists that this pressure around the optic     disc could affect the blood flow of the arteries that go through it.      The investigators will try to detect if a correlation exists between the optic nerve sheath     diameter and the blood flow in the retrobulbar vessels of glaucoma patients.   "
113337|NCT01802450|"     Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6     months in patients with CP-CML who have achieved complete cytogenetic response without major     molecular response after at least 18 months on Imatinib 400/600.   "
113338|NCT01802437|"     The purpose of the study is:        1. to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for          depression should get therapy before the therapist decides whether or not the teenager          is improving enough, and        2. to compare two ways of providing treatment to teenagers who have not improved enough.   "
113339|NCT01802424|"     The purpose of this pilot-study is to evaluate a cognitive behavioral program, the     Friends-program, as indicated prevention for anxious youth. The youths are recruited by     school nurses who will also lead the intervention groups applying the Friends-manual.   "
113340|NCT01802411|"     The purpose of the study is to examine the safety and efficacy of liposome bupivacaine for     intercostal nerve block in subjects undergoing posterolateral thoracotomy.   "
121772|NCT01692132|"     The purpose of this study is to determine the safety and effectiveness of prucalopride in the     treatment of Filipino patients with chronic constipation whom prior laxatives fail to provide     adequate relief.   "
113341|NCT01802398|"     Syncope (temporary loss of consciousness) is a frequent reason for an emergency department     (ED) visit among older adults. The current ED evaluation of syncope frequently leads to     hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of     this protocol is to improve risk prediction for syncope. Improved risk prediction will inform     the design of interventions to safely reduce unnecessary health service use.      This is a multi-center, prospective, observational cohort study of older (age≥60 years)     adults who present to an emergency department with syncope (otherwise known as fainting). The     primary outcome is a composite of 30-day cardiac death and serious cardiac events.      Study Aims and Hypotheses are:      Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for     admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic     tests.      H1: Current patterns of care representing a diversity of practice settings and patient     populations are costly with low clinical benefit.      Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death     and serious cardiac outcomes after unexplained syncope.      H2: Explicit criteria including contemporary cardiac biomarkers will improve risk     stratification compared to unstructured physician assessment and published risk models.      Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to     existing care for unexplained syncope.      H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating     unexplained syncope in older adults.   "
113342|NCT01802385|"     This is a phase III trial to determine whether adjunctive sertraline will lead to improved     survival 18-week survival.      There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF     concentrations in 172 persons conducted from August 2013 to August 2014.   "
113343|NCT01802372|"     The goal of this study is to evaluate the comparative effectiveness of the World Health     Organization Package targeted at Cardiovascular (CV) risk assessment and hypertension     control, delivered by Community Health Nurses as part of Ghana's Community based Health     Planning and Services program, versus provision of health insurance coverage, on blood     pressure reduction. Findings from this study will provide policy makers and other     stakeholders needed information to recommend efficient cost-effective policy with regards to     comprehensive CV risk reduction in patients with hypertension in low resource settings.   "
113344|NCT01802359|"     The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in     participants with erectile dysfunction.   "
113345|NCT01802346|"     This randomized phase II trial studies how well a controlled low calorie diet works in     reducing side effects and increasing response to chemotherapy in patients with breast or     prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Eating a special     diet with low calories may reduce the side effects of chemotherapy and improve the response     to treatment   "
113347|NCT01802320|"     This phase II trial studies how well v-akt murine thymoma viral oncogene homolog 1 (Akt)     inhibitor MK2206 works in treating patients with previously treated colon or rectal cancer     that has spread from the primary site to other places in the body or nearby tissue or lymph     nodes and cannot be removed by surgery. Akt inhibitor MK2206 may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
113348|NCT01802307|"     Prostate cancer is the most common solid organ cancer among men and is the second leading     cause of cancer death. In 2013 about 238,590 men will be diagnosed with prostate cancer and     29,720 men will die of the cancer. Overall, about 1 in 6 men will be diagnosed with prostate     cancer in their lifetime, but only 1 in 36 men will die. Currently, there are over 2.5     million men in the US living with prostate cancer. Standard treatment for prostate cancer has     involved either removal of the prostate (radical prostatectomy) or application of some type     of energy to the entire prostate gland in order to kill all of the cells--usually with     radiation or cryotherapy (freezing).      Over the past decade, it has become apparent that while some men will benefit from treatment     for prostate cancer, many will not. Particularly for men with a small amount of low-grade     (not very aggressive) type of prostate cancer, the risk of death from this very slow-growing     cancer is very low. However, the risk of harm from some of the treatments for prostate cancer     is very high. Treatment for prostate cancer can cause erectile dysfunction, urinary leakage,     difficulty urinating and overactive bladder and bowel symptoms.      One strategy for men with low risk prostate cancer has been to avoid immediate treatment and     wait until the cancer starts to grow. The risk of this strategy is that some men may not be     able to be cured once the cancer starts to grow. In addition, men who are on this active     surveillance protocol can become very nervous, fearing that the cancer will start to spread.      A new strategy to avoid some of the treatment harms of prostate cancer while also attempting     to avoid allowing the cancer to grow is called focal therapy. Many men with low-risk prostate     cancer will have only a small piece of cancer within the prostate gland. These men may     benefit from treating only this one area instead of the entire prostate. This will allow the     physician to kill the cancer cells and to avoid some of the problems associated with treating     the entire prostate.      The purpose of this study is to investigate the use of focal, targeted treatment of prostate     cancer, that is, to treat only the small area of cancer instead of the entire prostate. We     hope to show that this strategy will reduce the amount of side effects without compromising     cancer cure.   "
113349|NCT01802294|"     This pilot feasibility trial will evaluate the Sinovuyo Caring Families Program in a     small-scale randomized controlled trial in Cape Town, South Africa (n=60 families). The pilot     study will use a mixed-methods approach to intervention evaluation. Self-report and observed     quantitative data for intervention and control groups will be collected at pre-test and     post-test evaluation. Primary outcomes will include parent-reports and observations of child     behavior problems. In addition, as an exploratory study, this phase will examine initial     pre-post intervention effects for potential mediating factors of parenting behavior, parental     stress, parental depression, and perceived social support. However, this phase will not test     mediation effects due to small sample sizes. Quantitative assessments will also collect data     on program fidelity, exposure/adherence, participant engagement, and satisfaction.     Furthermore, qualitative focus groups with intervention participants and group leaders will     examine issues of program feasibility, content, deliver, and satisfaction. Randomization will     be done on an individual level and include a wait-list control group that will receive the     intervention 3 months after the post-test evaluation. Results from the feasibility pilot     study will be shared with intervention partners and advisory groups. If necessary, final     program adjustments will be made prior to further testing. Results will also be disseminated     to community forums, local organizations, government stakeholders, and via academic     conferences.      Research hypotheses:      Hypothesis 1: Children in the intervention group will demonstrate reduced observed and     parent-reported child behavior problems in comparison to the control group.      Hypothesis 2: Parents in the intervention group will demonstrate increased observed and     self-reported positive parenting outcomes and decreased observed and self-reported harsh and     inconsistent parenting outcomes in comparison to the control group.      Hypothesis 3: Parents in the intervention group will demonstrate decreased parental     depression and parental stress outcomes and increased perceived social support outcomes in     comparison to the control group.      Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable     degree of program fidelity, exposure/adherence, and participant satisfaction.   "
113350|NCT01802281|"     The primary purpose of this randomized clinical trial is to compare the effectiveness and     safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh     augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS).     The primary aim is to determine whether treatment success in women who undergo the above     strategies differ at time points through 3 years.      A supplemental study investigates anterior vaginal wall movement resulting from descent or     rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the     study arms of SUPeR.   "
114103|NCT01792362|"     This study is a prospective before & after clinical trial to compare the basal and 3 months     after diet anti-mullerian hormone levels between responders and non-responders to weight loss     diet in obese infertile women with PCOS population   "
113351|NCT01802268|"     Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin     inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate     long-term CNi associated adverse events. This study aims to evaluate the conversion from     tacrolimus to sirolimus in de novo kidney transplant recipients.      This multicenter, open-label study, planned to enroll 297 patients initially treated with     tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The     primary objective is to show superior glomerular filtration rate in the SRL group at 24     months after transplantation.   "
113352|NCT01802255|"     Patients needing intensive care often require sedative drugs to reduce anxiety and agitation     during ventilator care and invasive therapeutic and diagnostic procedures. At present there     is no optimal sedative agent for these patients. The most commonly used sedative agents in     intensive care units are midazolam and propofol. Both drugs have side effects of clinical     importance.      At present, a viable alternative to intravenous sedation is inhalatory sedation. Sevoflurane,     as other inhaled anesthetic agents, is sedative in low doses. A new simplified method of     administration of isoflurane or sevoflurane has been developed. The Anesthetic Conserving     Device is a modified heat-moisture exchanger (HME) that permits direct infusion of     sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.      However, the use of sevoflurane is limited to anesthesia and sedation lasting no more than 12     hours, since the possible renal problems posed by inorganic fluoride in prolonged operations     remain the subject of controversy.      The primary aim (and primary hypothesis) of the current trial is to determine whether     sevoflurane can be administered as a sedative drug for more than 48 hours without clinically     relevant physiopathological effects on kidney and liver function.      Other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in     terms of sedation control, the rapidity and predictability of awakening, and the incidence of     delirium in critical care patients.   "
113353|NCT01802242|"     Prostate cancer is common in males and may develop over the course of an individual's life.     This cancer is often discovered at the time of routine physical examinations and/or blood     work or on rectal examination. Once diagnosed, most patients do require some form of     treatment so that the prostate cancer does not progress to cause damage and/or shortened     lifespan. Occasionally, after patients receive treatment, the investigators have found that     an area of cancer remains within the prostate. Those patients with a large area of cancer     (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate     cancer even after standard treatment. Thus, the investigators believe that the area of the     prostate gland occupied by a dense area of cancer may need more radiation therapy than normal     to remain cancer free.      Standard therapy currently in place in North America: Currently patients who are diagnosed     with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT)     alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy     alongside the radiation depending on their physician's preference. For those who receive     radiation therapy, the tumor typically receives the same dose as the rest of the prostate     gland.      Findings to date: In the past few years the investigators have discovered that patients with     a tumor large enough to be seen on MRI images (>5mm) have a higher chance than normal of     having cancer remain in the prostate, despite receiving treatment for their cancer 3 years     earlier. Using new technology investigators can deliver radiation therapy after viewing the     prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted     to the tumor within the prostate. Based on this earlier success the investigators believe     that they can now safely give a higher dose of radiation to specifically target the cancer     within the prostate gland.      Reason for the study: The investigators would like to test this technology and expertise to     give radiation to a higher than normal dose to the tumor nodule in prostate gland.   "
113354|NCT01802229|"     The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes     and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of     umbilical port site.   "
113355|NCT01802216|"     The purpose of this study is (1) to determine whether a 12-month trial of patients from     underserved communities with clinically significant gum disease and kidney disease randomly     assigned to intensive gum disease treatment or delayed treatment is feasible and (2) to     determine the variability of various tests of kidney function and inflammation in response to     intensive gum disease treatment.   "
113356|NCT01802203|"     To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for     the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.   "
113357|NCT01802190|"     The study will allow to identify the prevalence of the SLC17A8 gene mutations in patients     suffering from deafness. This phenotype also corresponds to DFNA15 deafness caused by POU4F3     : mutations of this gene will be screened as well.   "
113358|NCT01802177|"     Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair     loss. Many treatment modalities have been found to be helpful in AA, however, none on them     cure the disease. UVB excimer light has recently emerged as a new therapeutic modality in     many dermatologic diseases. There are no prospective randomized controlled trials evaluating     the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split     lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer     light in the treatment of AA.   "
113359|NCT01802164|"     In patients undergoing laparotomy, the incidence of abdominal wall related complications such     as incisional hernia is very high. In particular in patients with peritonitis undergoing     laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are     at great risk for development of postoperative fascial dehiscence.      The gold standard of abdominal wall closure is a running slowly absorbable suture     irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh     potentially reduces the incidence of incisional hernia.      In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh     prophylactically we reduced the incidence of incisional hernia down to 3.2%.   "
113360|NCT01802151|"     The purpose of this study is to evaluate the effect of three doses of the probiotic B.     subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general     wellness in healthy young adults, survival through the gastrointestinal tract and impact on     intestinal microbes.   "
113361|NCT01802138|"     Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We     designed this study to determine the feasibility and safety of Activated T-lymphocyte cell     therapy for refractory/relapsed neuroblastoma patients.   "
113364|NCT01802099|"     The purpose of this study is to assess the hypothesis that, as compared to early intravenous     feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in     critically ill patients treated with mechanical ventilation and vasoactive drug.   "
113441|NCT01801059|"     This randomized clinical trial focused on activating the patient to ask their health care     provider for a colorectal cancer screening test to improve screening rates for colorectal     cancer. The patient activation intervention may increase information seeking, number of     screening tests ordered and number of completed screening tests for colorectal cancer.   "
113365|NCT01802086|"     The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief     or no pain relief in connection to the first pneumococcal vaccination at the age of three     months in Child health care.      Primary objective      1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at     the age of three months to lower pain scores in the use of FLACC as a pain measurement     instrument?   "
113366|NCT01802073|"     Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.   "
113367|NCT01802060|"     This study will examine the performance of the Persona assays in identifying the time when     risk of pregnancy is highest by comparing results to ultrasound observed ovulation and other     indices of ovulation.   "
113368|NCT01802047|"     Initiating and sustaining breastfeeding are common challenges in neonatal units.      It is known that hindmilk expressed at the end of the expression session has a higher fat     content.      Previous studies have shown that simultaneous pumping is more effective at producing milk     than sequential pumping. However this approach is often felt uncomfortable by the mothers,     and sequential pumping is preferred.      The purpose of this study is to determine which modality of milk expression by electric pump     is the most efficient and productive when sequential pumping is used.This is done by     assessing the milk volume expressed per expression and its macronutrients content.   "
113369|NCT01802034|"     A central goal of this data repository is to collect data from a large population of subjects     with a variety of renal disease states. Cohorts will include subjects with diabetes,     inflammatory/autoimmune and transplant related renal conditions. Additionally, the repository     will have the capacity to store biospecimens and electronic data in control subjects without     established renal disease. This initiative will provide an opportunity to compare data from     various disease states and controls with the objective of determining clinical and biological     factors that predict disease progression, response to therapy and identify discriminating     noninvasive clinical and biological features that predict renal biopsy findings.   "
113370|NCT01802021|"     The myeloid-derived suppressor cells (MDSCs) can further trigger cytotoxic T cell apoptosis,     and may shift the macrophages toward M2 subtype, inhibit the Th1 cell, and initiate other     immune suppressive mechanism. The functions of NK cells and regulatory T cells are altered,     resulting in a disturbance of anti-tumor immune function. All these can further create an     environment with a benefit for malignant cell growth and advancement. Astragalus-based     formula may confer its survival advantage in cancer patients through modulating the immune     system and reversing the immunosuppressive microenvironment.      The investigators aim to study the role of Qingshu-Yiqi-Tang in reversing the immune     alterations in patients with advanced stage, non-small cell lung cancer who receive 1st line     doublet chemotherapy of cisplatin plus doxetaxel（or Pemetrexed for adenocarcinoma）and 2nd     line target therapy of erlotinib. The investigators can explore the possible mechanism of the     Astragalus-based formula: Qingshu-Yiqi-Tang in modulating and reversing immunosuppression in     advanced stage, non-small cell lung cancer patients.   "
113371|NCT01802008|"     The objective of this study is to determine the optimal withdrawal time for colonoscopy. A     6-minute withdrawal time is currently the standard of care but has only been evaluated in an     observational fashion. The investigators believe that this should be validated in a     standardized fashion. If the benefits of a 6 minute withdrawal are proven in this study (ie a     low polyp/adenoma miss rate and a high polyp/adenoma detection rate), then this will support     widespread adoption of a 6 minute withdrawal as the standard of care. This in turn may     decrease the occurence of 'interval colon cancers', which are early colon cancers arising in     subjects despite their having undergone colonoscopy. Our hypothesis is that the polyp/adenoma     detection rate will be unacceptably low and the polyp/adenoma miss rate will be unacceptably     high in the 3-minute withdrawal group when compared to the 6-minute withdrawal group.   "
113372|NCT01801982|"     This single center study will monitor the developmental progress of PPHN patients who     received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months     following the end of study drug infusion.   "
113373|NCT01801969|"     The proportion of patients who return to work after surviving severe traumatic brain injury     (TBI) has been estimated in number of studies but results do not agree.This may be due to     complex interaction between many factors, including available rehabilitation services.      In Denmark rehabilitation services vary been regions and municipalities. Hospital based     rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized     by the municipalities      The first purpose of this study is to investigate a possible link between centralized     hospital based rehabilitation and better return to work / quality of life.      The second purpose is to investigate whether municipality size affects quality of life and     return to work after severe TBI.      Data on return to work are derived from a national register on labor market attachment. Data     on quality of life are derived from a questionnaire.      The study population is identified from the Danish Head Trauma Database. The completeness and     accuracy of the database will be investigated as the first part of the project.   "
113389|NCT01801761|"     To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive     pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a     simplified questionnaire was developed for identifying those COPD patients with severe OSA.   "
113390|NCT01801748|"     Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance     is exceedingly difficult and imposes major dietary restriction. The purpose of this study     were to determine the rate of oral tolerance and identify clinical and laboratory predictors     of tolerance development in Thai children who allergic to wheat.   "
113391|NCT01801735|"     The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up     to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip   "
113392|NCT01801722|"     The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an     initial step for the diagnosis of chronic heart failure in patients with COPD in primary     health care, and to select patients for a further examination by echocardiography.   "
114187|NCT01791244|"     This is a randomized, comparative, and multicenter study to assess the impact of a patient     support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in     subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™     device.   "
113374|NCT01801956|"     Background: Low levels of cardiorespiratory fitness are associated with high risk of     non-communicable diseases and all-cause mortality. Physical activity level is the primary     determinant of cardiorespiratory fitness in adults. However, knowledge on how to motivate     people to engage in physical activity and maintain an active lifestyle is lacking. This study     aims to investigate whether a motivational, individual, and locally anchored exercise     intervention, in primary care, can improve cardiorespiratory fitness in 30 to 49 year olds     with a low or very low cardiorespiratory fitness.      Design: Randomised controlled trial with 6 and 12 months follow-up. The primary outcome is     cardiorespiratory fitness. Secondary outcomes include biochemical parameters (HbA1C, HDL- and     LDL-cholesterol, and triglyceride), physical activity level (measured by accelerometer),     self-reported physical activity, anthropometric parameters and health-related quality of     life.      Methods: Cardiorespiratory fitness will be estimated via a maximal incremental exercise test     and expressed as the index of maximum oxygen uptake per minute divided by body weight (ml     O2/kg/min). A total of 236 participants, classified with a very low or low cardiorespiratory     fitness at a local health check programme, (corresponding to ≤ 39 and ≤35 ml O2/kg/min. for     30-39 and 40-49 year-old men respectively and ≤33 and ≤31 ml O2/kg/min. for 30-39 and 40-49     year-old women respectively), will be randomised into two groups. The intervention group will     receive 4 motivational interviews, six months membership to a sport club, and a global     positioning watch to upload training activity to a social media. The comparison group will     receive standard care: a one hour motivational interview. In addition to an     Intention-to-treat analysis a per-protocol analysis will be performed. Effect of the     intervention will be estimated by evaluating the differences in mean changes in     cardiorespiratory fitness between the two groups.      Discussion:In new and innovative ways the focus of this study will be to improve     cardiorespiratory fitness among a 30-49 year-old at-risk group using social media,     GPS-technology, on-going personal support and individually tailored physical activity.   "
113375|NCT01801943|"     The purpose of this study is to determine the effects of a coordinated intervention of     cognitive remediation training (CRT) and walking intervention on cognition and gait in the     elderly.   "
113376|NCT01801930|"     To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed     Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy   "
113377|NCT01801917|"     This study will assess the efficacy, safety and tolerability of BAF312 administered orally in     patients with clinically active polymyositis and also in patients with polymyositis who have     shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic     drugs).   "
113378|NCT01801904|"     The purpose of this study is to assess if panitumumab is active enough to warrant comparative     studies in patients with metastatic colorectal cancer that has progressed after treatment     with cetuximab.   "
113379|NCT01801891|"     This study aims to determine if the use of surface neuromuscular electrical stimulation,     applied to various motor points on the lower limb to elicit muscle contraction when combined     with compression bandaging accelerates the rate of venous leg ulcer healing.   "
113380|NCT01801878|"     The aim of this study is to evaluate the skin quality of using adipose-drived stromal     vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation     system into irradiated breasts.   "
113381|NCT01801865|"     The purpose of the present study is to make medically indicated state of the art/high end     magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's     Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).   "
113382|NCT01801852|"     The purpose of this study is to assess the safety and effectiveness of natural killer T (NKT)     cell-based autologous adoptive immunotherapy in subjects with metastatic,     treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung     cancer, pancreatic cancer, colon cancer or prostate cancer.   "
113383|NCT01801839|"     The imbalance between anti- and pro-inflammation often occurs in patients with sepsis. And     continuous such imbalance could lead to immunoparalysis, which is characterized by loss of     delayed type hypersensitivity, failure of primary infections eradication, and a     predisposition of secondary nosocomial infections development. However, in which phase of     sepsis does immunoparalysis occur is still unknown. So this study aims to tentatively     understand this problem by checking monocytes/macrophages` antigen presentation and cytokine     secretion，and by checking monocytes/macrophages` expression of Tim-3 (the T cell     transmembrane, immunoglobulin, and mucin-3), which is an inhibitory regulatory molecule, in     sepsis patients` peripheral blood mononuclear cells.   "
113384|NCT01801826|"     myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive     facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience     Cryo-Touch IV device uses well-established principles of cryobiology to cause localized     reduction in muscle activity resulting in a reversible reduction in facial animation and the     appearance of facial lines. The device operates on well-established cryobiology principles;     that localized exposure to controlled low temperature conditions can alter tissue function.     The therapy treats targeted motor nerves with low temperatures via a cold probe in the form     of an assembly of small diameter needles, creating a highly localized treatment zone around     the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction     resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch,     Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety     for applications in this indication. The goal of the study described herein is to show the     safety and effectiveness of this approach using the Cryo-Touch IV device.   "
113385|NCT01801813|"     Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but     lifethreatening post-operative complications. There are currently no strong recommendations     to help the clinician in an attempt to properly hospitalise these patients after their     intervention (Neuro-ICU, ICU,surgical ward).      Determining risk factors of post-operative complications could optimise resources. Therefore     hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.   "
113386|NCT01801800|"     Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact     patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon     Federation Score ≥ III   "
113387|NCT01801787|"     The current study investigates the basic principles that underlie the efficacy of     transcranial direct current stimulation for chronic auditory verbal hallucinations in     schizophrenia in a multimodal design.   "
113388|NCT01801774|"     Phacoemulsification is a quick method with less complication for cataract surgery. Due to the     use of ultrasonic energy, it produced more post-operative inflammation than other methods.     Many routes of steroid had been used to control post-operative inflammation. The     investigators here compare the efficacy of single depot steroid subtenon injection (20-mg     triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling     inflammation after uneventful phacoemulsification.   "
113393|NCT01801709|"     The objective of this open-label, single arm, monocentric, phase I/II clinical study is to     assess safety and efficacy of ARSA gene transfer in the brain of children affected with early     onset forms of Metachromatic Leukodystrophy (MLD). For this purpose, an adeno-associated     virus serotype rh.10 (AAVrh.10) vector will be used to transfer the ARSA cDNA coding for     Arylsulfatase A (ARSA) enzyme into the brain of children. Five patients with early onset form     of MLD, age ranging from 6 months to 4 years, will be included in this protocol and will be     followed during 24 months.      Patients will be selected at presymptomatic or early stage of their disease, following     clinical, neuropsychological and brain imaging criteria.      Twelve simultaneous injections of the investigational medicinal product will be performed in     the white matter of both brain hemispheres, through 6 image-guided tracks, with 2 deposits     per track.      A low dose (1x10EXP12 vg total) will be administered to the first 2 patients, while the last     3 will receive a higher dose (4x10EXP12 vg total).      Safety and efficiency will be evaluated based on clinical, neuropsychological, radiological,     electrophysiological and biological parameters.   "
113394|NCT01801696|"     Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute     at Western Oregon University (WOU) will be conducting research on the effect of a     parent-delivered massage program on measures of autism and general development in young     children with autism. Families will participate in an initial training, and receive 24     sessions of ongoing support and training from a trained therapist over the first nine months.   "
113395|NCT01801683|"     Evidence-based medicine (EBM) is the basis of work for physicians- practitioners in all     specialties, including family medicine. Various issues in diagnosis, treatment and prognosis     appear in daily work with patients and a physician should provide answers based on the best     evidence stemming from research. In spite of having access to EBM databases in every GP's     office in Croatia, searching and finding answers in consultation with a patienton the spot     in real time is missing from practice.      OBJECTIVES: To determine GP's knowledge and attitudes about EBM before and after applying     modified academic detailing EBM intervention. provided by sixth- year medical students We     assume that GP's knowledge and attitudes about EBM will change as a result of EBM     intervention applied by students.   "
113396|NCT01801670|"     Mycosis Fungoides (MF) is a rare malignancy in the United States. It is the most common form     of cutaneous T-cell lymphoma (CTCL). Sézary syndrome (SS) is the most severe and leukemic     form of CTCL. Pruritus, or itch, is defined as an unpleasant sensation that elicits the     desire to scratch. Severe itch is a manifestation of all forms of MF, especially those with     patch/plaque and folliculotropic variants, as well as in Sezary patients. While severe itch     causes great suffering for patients, the pathogenesis of itch in MF and Sezary syndrome is     complex and not well understood. It is thought that various chemical mediators are produced     by the malignant cells to cause itch. Vorinostat, an FDA approved therapy for the treatment     of MF, has also been reported to relieve pruritis. The goal of the study is to evaluate how     vorinostat affects different chemicals in the skin that have been known to cause itch. This     is a single center, non-randomized study designed to obtain and test blood and skin tissue     samples take at various time-points over 6 months in patients who are prescribed vorinostat     per standard of care treatment. Samples from pruritic and non-pruritic skin and blood of MF     and Sezary patients will be evaluated for the presence of chemicals thought to be important     in the cause of itch in these diseases. This evaluation will include immunohistochemistry,     RT-PCR, and ELISA assays. The results from this study may help define how vorinostat     decreases itch in patients with MF and Sezary Syndrome.   "
113397|NCT01801657|"     Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and     bronchioles leading to persistent cough, purulent sputum, and airway ﬂow limitation, which     may be accompanied by recurrent exacerbations.It has been increasingly recognized that     respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary     diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis.     However,little is known about the roles of viral infection in driving exacerbations of     bronchiectasis.This study aims to identify the frequency of common viral infections and     determine the roles that viruses play in acute exacerbations of bronchiectasis.   "
113398|NCT01801644|"     To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in     locally advanced bladder cancer.   "
113399|NCT01801631|"     Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result in     a decreased quality of life and increased distress. According to the American Diabetes     Association, transition from the acute care setting is a high-risk time for all patients, but     tailored support specific to diabetes is scarce in that period. The investigators developed     an intervention by a diabetes nurse to help diabetic patients reduce distress after their     first ACE. The intervention is based on Bandura's Social Cognitive Theory, Leventhal's Common     Sense Model, and on results of focus groups which were conducted to define the needs and     wishes of type 2 diabetes patients and their partners regarding professional support after an     ACE. The aim of this study is to evaluate the effectiveness of the intervention to reduce     distress. The hypothesis is that patients who receive the intervention will have less     diabetes related distress compared to the control group.      Methods/Design: Randomized controlled trial. Patients will be recruited directly after     discharge from hospital. A diabetes nurse will visit the patients in the intervention group     (n = 100) within three weeks after discharge from hospital, two weeks later and two months     later. The control group (n = 100) will receive a telephone consultation. The primary outcome     is diabetes related distress, measured with the Problem Areas in Diabetes questionnaire     (PAID). Secondary outcomes are quality of life, anxiety, depression, HbA1c, blood pressure     and lipids. Mediating variables are self-management, self-efficacy and illness     representations. Variables will be measured with questionnaires directly after discharge from     hospital and five months later. Biomedical variables will be obtained from the records from     the primary care physician and the hospital. Differences between groups in change over time     will be analyzed according to the intention-to-treat principle.      Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after     discharge from the hospital. This trial will provide evidence of the effectiveness of a     supportive intervention to reduce distress in these patients.   "
113400|NCT01801618|"     Medium and long term efficacy of PI-based 2nd line antiretroviral (ARV) therapy in Cambodia     is poorly documented when the numbers of patients on treatment and their duration are     increasing. For patients in treatment failure , there is no alternative ARV regimen available     to date.      This operational research aims to evaluate the Cambodian National Program PI-based 2nd line     antiretroviral regimen to assess the proportion of treatment failure and drug resistance     ;identify the structural and individual factors associated with treatment failure ; design     alternative salvage ARV regimens.   "
113401|NCT01801605|"     The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic     Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS)     in a prospective, randomized, double-blind study.   "
113402|NCT01801592|"     The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is     in individuals with intermittent claudication.   "
113404|NCT01801566|"     This study aims to evaluate the treatment with single implant overdenture for the edentulous     mandible. The investigators hypothesize that treatment with lower overdenture retained by a     single implant appears to have satisfactory effectiveness as a treatment for patients with     specific conditions (such as maladaptive patients), with the advantages of simplicity and     greater immediate benefits when compared to the conventional full denture, improving the     retention and stability of the denture and better oral-related quality of life.   "
113405|NCT01801553|"     The purpose of this study is:      - To validate or not the interest of the classification using the pragmatic application of     clinical predictive rule for low back pain to identify patients with good prognosis following     a brief spinal manipulation intervention.      Patients (n = 100 to 150) :      Recruited from emergency department of Saint-Luc hospital by medical doctors      Inclusion criteria:      A. Non-specific (No red flags) acute low back with mobility deficit (limitation in bending)     and a pain duration < 16 days and no symptoms distal to the knees, male and female patients     aged 19-55 years.      Exclusion criteria:        -  Specific LBP (red flags) and radiating beyond the knee        -  Low Back Pain Non-specific subacute and chronic        -  Recurrent low back pain (more than 3 painful episodes)        -  Lumbar instability or hyper laxity (instability catch, active straight leg raise (SLR) >          90°, aberrant movement,range of motion (ROM) of le lower lumbar spine > 50° during          standing flexion), pregnancy and post-partum status        -  High irritability = necessity of opioid medication or intravenous injection of          medication in the emergency department        -  previous history of surgical intervention in the low back area      Intervention:      - 3 sessions within one week of spinal manipulation (thrusts, grade V)      comparison:      - 3 sessions of false/sham manipulation (placebo) in side lying on thoraco-lumbar hinge in a     grade II      Co-intervention similar in both group:      = traditional medical care (TMC)      - Reassure patients, avoid bed rest, advise them to stay active and to take analgesics (if     needed such as paracetamol) (European Guidelines for non-specific acute low back pain ; van     Tulder et al. 2006 ; Koes et al. 2010).      Outcomes:      Use of effect sizes by standardized mean of difference. ANOVA one and Two Way, number needed     to treat (NNT) analysis and intention to treat analysis on all outcome variables:        -  Primary: Kinematic Variables: two indices, logit score for the amplitude and velocity          (Hidalgo et al., 2012) and patient's expectation from manual therapy (MT) treatment to          improve his LBP        -  Secondary: Pain in the presentation with visual analogical scale (VAS) and the          repartition (body diagram), Oswestry Disability Index (ODI, questionnaire on pain and          function), patient specific function (PSF), fear avoidance beliefs questionnaire (FABQ),          Start back tool, physical examination, medication use, return to work and treatment side          effects, patient's belief in a real MT intervention or not (at the end of the follow-up)      Study design:        -  Double blind ie: patients and assessors blind.        -  The methodological quality of the study is the 8-9/10 on the PEDro scale, we will          strictly follow the CONSORT statement and will be register in clinical.trials gov      Evaluators:      Christine Detrembleur (PT-PhD-UCL), Maxime Gilliaux (PT-PhD-student-UCL)      Responsible for the study: Henri Nielens (MD-PhD-UCL)      Practitioner and investigator:      Benjamin Hidalgo PE, PT-MT, DO, PhD-student Certificate in Orthopedic Manual Therapy (Manual     Concepts, Curtin University) Assistant-Professor Faculty of Physical therapy (FSM-UCL)     Belgium      International collaborator:      Timothy Flynn (PT-PhD), Regis University, Denver, USA   "
113406|NCT01801540|"     The purpose of this study is to investigate the effect of a meal containing different doses     of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring     the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and     GLP-1) to explain the correlations.   "
113407|NCT01801527|"     Background: Cancer is increasingly viewed as a chronic disease and therefore there is a     growing need for long-term treatments. Breast cancer survivors suffer physical impairment     after oncology treatment. This impairment reduces quality of life (QoL) and increases the     prevalence of conditions associated to unhealthy life-style.      Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short     and long-term effects telehealth program.      Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited     through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio     Hospital and associations of breast cancer patients in Granada. Patients will be randomized     to receive the online rehabilitation group (n=36) or usual care (control) group (n=36).     Telerehabilitation group will receive an eight-week online intervention and control group     receive recommendations about usual care.      Discussion: The investigators study attempts to increase the level of fitness and reduce     musculoskeletal disorders in breast cancer patients through a strategy for care based on     telerehabilitation to promote therapeutic exercise.   "
113408|NCT01801514|"     The purpose of the study is to evaluate the feasibility of multilayer detection-based dual     energy computed tomography scanner and to assess the added diagnostic value of dual energy     applications   "
113409|NCT01801501|"     The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth     Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.   "
113410|NCT01801488|"     Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to     identify a genetic difference between the two types of aneurysms; and to test SNP's in     arteriovenous malformation tissue to identify a genetic link.   "
113411|NCT01801475|"     This is called Aim 1 of the investigators' NIH grant. Ondansetron (Zofran) is a safe and     effective drug used in pregnant women to prevent nausea but the investigators do not know     what effect pregnancy may have on the metabolism of Zofran in pregnant women or their babies.     Therefore the investigators will enroll approximately 40 pregnant women and their babies and     draw blood samples from the mother, the baby and the cord, to determine how much Zofran is in     each sample of blood (called the pharmacokinetics or PK of Zofran). The pregnant women will     receive Zofran, as a standard-of-care drug, for their scheduled Cesarean Section.      The investigators will also enroll about 20 non-pregnant women undergoing surgery who will     receive Zofran as standard-of-care during surgery. In both the pregnant & the non-pregnant     women, the investigators will draw blood samples at the same time points based on number of     minutes from the time the Zofran is given. The blood data (PK of Zofran) will help the     investigators move into Aim 2 of the study, which will be done in pregnant, narcotic-addicted     mothers and their babies who are born addicted to narcotics. Aim 2 will be listed separately     as it will be an interventional study.   "
113412|NCT01801462|"     Ultrasonography has become increasingly used in many medical specialties over the last     decades as smaller and less expensive ultrasound equipment has become available. Although     ultrasound imaging traditionally is considered safe, its use is highly operator dependent     (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic errors that     eventually compromise patient safety due to unnecessary tests or interventions (Moore & Copel     2011). A recent report from the British National Health Service (NHS) analyzed maternity     claims reported to the NHS over the past decade and identified antenatal fetal ultrasound     investigations as one of the four major risk areas in obstetric care (NHS 2012). This study     therefore aims to explore the effects of simulation-based ultrasound training on patient     comfort levels and the need for re-examination by a second physician due to diagnostic     uncertainty.   "
113413|NCT01801449|"     Background:      - Deficiency of the IL-1 receptor antagonist (DIRA) is a condition that causes repeated     episodes of inflammation. People with DIRA can have rashes, fever, and joint pain. Most     treatments for DIRA are intended to control the immune system to stop these inflammations.     There are drugs that can treat DIRA, but they have to be given daily as injections.     Researchers want to try another drug, rilonacept, as a treatment for DIRA. It needs to be     given only once a week. Rilonacept will be given to individuals who are at least 3 months old     and who have DIRA.      Objectives:      - To test the safety and effectiveness of rilonacept for children and adults with DIRA.      Eligibility:      - Individuals at least 3 months old who have DIRA.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Other tests to study pain and movement will be given. Imaging          studies such as bone density scans and x-rays may also be taken.        -  Participants will have a minimum of four to five study visits over 12 months. Those who          are on different anti-inflammatory drugs (such as anakinra) will stop taking them before          beginning the study visits.        -  Participants will have rilonacept injections weekly while on this study. The dose will          be adjusted as needed to help treat the DIRA symptoms. Participants will keep a diary to          monitor their symptoms and any side effects.        -  Treatment with rilonacept will be given for 1 year. Participants will have study visits          to monitor the treatment. They will provide blood samples and have other tests at these          study visits.   "
113478|NCT01800578|"     the aim of this study was to estimate the relations between Bispectral Index values and     explicit or implicit memory or dreams during two different minimal alveolar concentration     (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery     and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like     epidural analgesia, the requirement of halogenated volatile anesthetics.   "
113414|NCT01801436|"     The purpose of this post marketing study is to determine the plasma concentration of     bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug     enters and leaves the blood and tissues over time) properties in the Taiwanese population. It     will also provide expanded access (expanded access, sometimes called compassionate use, is     the use of an investigational drug outside of a clinical trial to treat a participant with a     serious or immediately life-threatening disease or condition who has no comparable or     satisfactory alternative treatment options) to bortezomib for the same group of participants     with multiple myeloma (cancer of the types of cells normally found in bone marrow).   "
113415|NCT01801423|"     Given large absolute numbers of individuals with sickle cell disease in Nigeria, hydroxyurea     therapy for all individuals with sickle cell disease may not be initially feasible; however,     a targeted strategy of hydroxyurea use for primary prevention of strokes is an alternative to     the standard therapy (observation) for high-risk individuals. The investigators propose a     feasibility study, Sickle Cell Disease - Stroke Prevention in Nigeria (SPIN) Trial, to     determine whether hydroxyurea can be used for primary prevention of strokes in Nigerian     children with sickle cell anemia.   "
113416|NCT01801410|"     Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia.     Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with     pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby,     preferably by vaginal route, is vital in order to achieve good maternal and neonatal     outcomes. Induction of labour is therefore a critical intervention in order to prevent     morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and     transcervical Foley catheterization - are already used by some in low resource settings, but     their relative risks and benefits are not known. These interventions could optimize the care     pathway for women needing induction of labour. This is especially important in low resource     settings where improvement is most needed and the potential to reduce the maternal and     neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a     relatively short induction to delivery interval without risk to fetus and with low rates of     emergency caesarean section. The induction to delivery interval is especially important in     pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery.     Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine     hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley     catheter as an induction agent has been persistently questioned. This study will identify the     risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low     cost induction methods.   "
113417|NCT01801397|"     Study Title:      A pilot study to evaluate the effect of Forsteo® (Teriparatide, 1-34 rh-PTH) in Anorexia     Nervosa patients with low mineral density and increased bone fragility (FAN-Trial)      Short Title/Study ID:      FAN-Trial / Psy-Rheu_2011/1      Indication:      Low bone mineral density (Z-Score < -1.5 or T-Score < -1.5 if available) and fragility     fractures or very low bone mineral density (Z-Score < -2.5 or T-Score <-2.5 if available)     without fragility fractures in Anorexia Nervosa patients      Trial Design:      Open-label, single-centre pilot study with study drug treatment duration of 24 months.      Study Center:      Single-centre (University Hospital of Zürich)      Investigator(s)/Authors:      PD Dr. med Gabriella F. Milos (Principle Investigator and author), Dept of Psychiatry, Centre     for Eating Disorders, University Hospital Zürich, CH-8091 Zürich Dr. med. Diana P. Frey     (Co-Investigator and author), Dept. of Rheumatology, University Hospital Zürich, CH-8091     Zürich PD Dr. med. Daniel Uebelhart (author), SUVA Fribourg, CH-1701 Fribourg      Objective(s)/Outcome(s):      Primary endpoint:      •To assess the efficacy of Teriparatide (Forsteo®) in increasing the bone mineral density in     the lumbar spine, total hip and femoral neck in patients with anorexia nervosa and low bone     density at months 12 and 24.      Secondary endpoints:        -  To assess the changes in blood biomarkers        -  To assess changes in whole body composition        -  To assess the incidence of new fragility fractures        -  To assess changes in bone structure        -  To assess the changes in EDE-Q        -  Longterm safety and tolerability of Teriparatide (Forsteo®) in patients with AN      Assessments for primary endpoint:      •BMD at lumbar spine, total hip and femoral neck, measured by DXA      Assessments for secondary endpoints:        -  bone resorption and bone formation markers measured in urine and serum        -  whole body composition measured by DXA        -  New clinical peripheral and vertebral fractures        -  HRqCT of tibia and forearm        -  EDE-Q Score at months 12 and 24      Safety measurements:        -  Safety lab (blood and urine)        -  Clinical adverse event monitoring at all visits Number of Subjects: 10      Diagnosis and Main Inclusion Criteria:        -  Women, aged > 18 to < 35 years        -  Having severe anorexia nervosa (AN) (DSM-IV-R) for > 12 months before screening        -  Presenting with very low bone mineral density (defined as Z-Score < -2.5 or T-Score <          -2.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4,          total hip, femoral neck) without any previous fragility fracture        -  or low bone mineral density (defined as Z-Score < -1.5 or T-Score < -1.5 if available)          of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral          neck) and at least one previous fragility fracture        -  In- and out-patients of the Centre for Eating Disorders at the Clinic for Psychiatry and          Psychotherapy of the University Hospital of Zurich.      Main Exclusion Criteria:        -  Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism,          osteomalacia, Paget's disease of bone), pre-existing hypercalcemia, severe renal          impairment (GFR < 30 ml/min), prior external beam or implant radiation therapy to the          skeleton, skeletal malignancies or bone metastases, any unknown elevation of serum          alkaline phosphatase, severe psychiatric diseases other than AN, drug addiction, HIV          positive patients, pregnancy, open epiphyses        -  Incapacity to understand the aims of the study or patients not willing to collaborate.      Study Product, Dose, Route, Regimen:      Teriparatide (Forsteo®), 20µg s.c. daily for 24 months.      Duration of study:      24 months.      Reference therapy, Dose, Route, Regimen:        -  Trial with medicinal product   "
113418|NCT01801384|"     The major goal of this project is to examine the efficacy of a voucher-based incentive     program for promoting smoking cessation (Study 1) and preventing relapse (Study 2) during     pregnancy and postpartum. Identifying efficacious interventions to increase cessation rates     and decrease relapse among those who are able to quit is important to improving U.S. public     health.   "
113419|NCT01801371|"     This is an open-label brain PET/CT (positron emission tomography/computed tomography) study     to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in     glioma patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤40 µg BNOTA-PRGD2) will     be intravenously injected into patients in suspicion of glioma. Visual and semiquantitative     method will be used to assess the PET/CT images. Brain MRI with/without enhancement and     18F-FDG PET/CT will be performed for comparison. The postoperative pathology and integrin     αvβ3 and CD34 immunohistochemical stains will also be used for correlation.   "
113420|NCT01801358|"     A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with     confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose     limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the     combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in     a Phase II part of the study, which will enrol 55 patients each into two randomized groups:     the combination therapy or MEK162 alone. The Phase II part will continue until proof of     concept is established. Patients will continue treatment as long as clinical benefit is seen     and no limiting adverse toxicity is observed   "
113421|NCT01801345|"     The primary aim of this randomized controlled trial is to examine the effect of fatigue on     clinical performance in a simulated obstetric emergency. This scenario was chosen because it     is a common clinical situation faced by anesthesia providers on call and therefore likely to     occur when a provider is fatigued. Secondary outcomes will include the evaluation of other     factors that worsen fatigue related decrement in performance including age, years of     training/practice and clinical load prior to study participation.   "
113422|NCT01801332|"     To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in     association with corticosteroïds in patients with severe acute alcoholic hepatitis.   "
113423|NCT01801319|"     This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety,     efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate     Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression     (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10     participants per sequence). Each participant will be treated over a 6-month period with     active or sham stimulation in which both the participants and the attending psychiatrists     will be blinded to treatment allocation.   "
113424|NCT01801306|"     To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring     (NeMo Probe) and the accuracy of measurement values.      To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and     oxygenation during cerebrovascular events monitored with established methods including brain     tissue oxygenation tension and microdialysis   "
113425|NCT01801293|"     This is a single center, open-label, Phase 1 study to determine the mass balance of of     GS-5806 following administration of a single, oral dose of radiolabeled [14C]-GS-5806 in     healthy subjects.   "
113426|NCT01801280|"     The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of     Pantoprazole on the bioavailability mycophenolic acid administered as either Mycophenolate     mofetil (Cellcept(R) or Mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft     recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose     glucocorticoids).   "
113427|NCT01801267|"     Ventriculoperitoneal shunts are the standard of care for patients with communicating     hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail     within 2 years. It has long been assumed that endoscopic third ventriculostomy (ETV) would     not work in this population and is better suited to patients with obstructive hydrocephalus     (such as from a tumor blocking cerebral-spinal fluid (CSF) pathways). However, as scientists     learn more about CSF and the way our brains absorb this fluid, they have learned that this     may not be so straight-forward. Recent small studies have shown that ETVs can work in a good     percentage of children with communicating hydrocephalus, too. But no randomized controlled     trials have been done to compare these two treatments directly to determine which will     provide children with a better prognosis, fewer surgeries over their lifetime, less time in     the hospital and the greatest chance at as normal a life as possible.      The investigators will conduct a trial to compare these two surgical treatments where     patients will be randomized to receive either a shunt or an ETV. Because ETV has been shown     to have a high failure rate in newborns, the investigators will not include these patients     and instead will study patients who come to Duke University with communicating hydrocephalus     between the ages of 1 year and 18 years. The study will include patients with ventricular     shunts who are in need of revision and patients who were just diagnosed and need their first     shunt.      All patients who agree to participate will be randomized to receive either an ETV or a shunt.     The study team will follow them for one year from the time of the surgery and will determine     what percentage of patients require further CSF-related surgeries, how long they go after     their surgery before they need another surgery, how much time they spend in the hospital and     what percentage of patients suffer CSF-infections or other problems related to the surgery or     their hydrocephalus. The study team will examine these results and determine if ETV is a     safer or more effective treatment for children with communicating hydrocephalus than is a     ventricular shunt.   "
113428|NCT01801254|"     The field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control;     however, researchers have not yet harnessed neuroeconomics findings to develop interventions     for improving self-control ability. The investigators are currently developing such an     intervention. The investigators' approach involves using a brain-computer interface with     audiovisual feedback to show people what is happening in their own brains, in real time.     Through this interface, individuals are trained to increase levels of neural activity that     may facilitate self-control, which, in turn, may improve the ability to exhibit     self-controlled behaviors. This may increase the ability to engage in heath behaviors for     which self-control is required (eg, dieting and exercising). The investigators' long-term     goal is to create a tool that will help people develop the self-control needed to achieve     lasting improvements in health behaviors.   "
113429|NCT01801228|"     This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone,     a selective aldosterone antagonist, regarding efficacy and hormonal side effects when     treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The     investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of     ascites with less side effects such as painful gynecomastia.   "
113430|NCT01801202|"     -  The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for          removal of unwanted hair, and will result in hair removal and permanent hair count          reduction.        -  Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.        -  Each subject will receive five treatments at four to six week intervals and return for          follow-up visits at three and six months after the last treatment for evaluation of the          treated areas.   "
113431|NCT01801189|"     Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will     alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly     obese patients undergoing laparoscopic gastric bypass surgery.   "
113432|NCT01801176|"     It's a monitoring study. The aim is to assess the progression free survival up to 3 years.     Patients are not treated until progression. Search for scalability predictive factors and     registration of treatments if progression.   "
113433|NCT01801163|"     This is a research study of a radiation treatment called stereotactic body radiotherapy     (SBRT) plus a medicine called sorafenib. The purpose of this study is to evaluate the safety     of SBRT plus Sorafenib to see what effects (good and bad) it has on the treatment of liver     cancer.   "
113434|NCT01801150|"     Aim: To assess if six months of treatment with CPAP associated with conventional drug     therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep     apnea-hypopnea syndrome SAHS)   "
113435|NCT01801137|"     A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients     with transitional cell carcinoma of the urothelium which failed or progressed after two lines     of chemotherapy   "
113436|NCT01801124|"     Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the     Transversus Abdominis Plane (TAP).   "
113437|NCT01801111|"     This open-label, non-randomized, multicenter phase I/II study will evaluate the safety and     efficacy of RO5424802 in patients with non-small cell lung cancer who have ALK mutation and     failed crizotinib treatment. In Part 1, cohorts of patients will receive escalating doses of     RO5424802 orally twice daily. In Part 2, patients will receive the recommended phase II dose     of RO5424802 as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the     same dose until disease progression. In Part 3, following disease progression, patients     without EGFR mutation will be offered continued treatment with RO5424802, patients with EGFR     mutations will be offered a combination of RO5424802 and Tarceva (erlotinib).   "
113438|NCT01801098|"     The development of a high grade AV-block is a frequent complication associated with     transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be     enrolled in this study. The HV-interval will be determined before and immediately after     implantation.      The hypothesis is that a prolonged HV-interval is associated with a high rate of complete     AV-block following TAVI.   "
113439|NCT01801085|"     This is a prospective time-and-motion study to document and compare the time used in     preparation, dispensing and administration for capecitabine/oxaliplatin (XELOX) versus IV     5-FU/leucovorin/oxaliplatin (FOLFOX4) regimens in colorectal cancer (CRC) patients.   "
113440|NCT01801072|"     After a thorough review of the existing literature as well as a review of our own practice,     the investigators have concluded that the decision to treat patients undergoing aneurysm     repair with levetiracetam has reached true clinical equipoise. In other words, the     investigators cannot favor a decision to either administer or not administer this drug in     these patients based on the existing information. The utility of anti-epileptic prophlaxis in     the perioperative period for patients undergoing intracranial aneurysm repair remains a     common practice that is not supported by the current literature that includes retrospective     analyses as well as prospective trials for similar but not identical types of patients. The     investigators propose to settle this dilemma by performing a prospective randomized trial in     patients undergoing aneurysm repair in order to definitively determine if the common practice     of perioperative antiepileptic drug administration has any utility.   "
113442|NCT01801046|"     This phase I trial studies the side effects of donor stem cell transplant in treating     patients with high risk acute myeloid leukemia. Giving low doses of chemotherapy before a     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may     also stop the patient's immune system from rejecting the donor's stem cells when they do not     exactly match the patient's blood. The donated stem cells may replace the patient's immune     cells and help destroy any remaining cancer cells (graft-versus-tumor effect)   "
113443|NCT01801033|"     Background:      - Hypothyroidism is a condition caused by the loss of function of the thyroid gland. The     thyroid gland produces two hormones, T4 and T3. These hormones control the metabolism and     function of many organs. Lack of energy, depression, and constipation are common symptoms of     hypothyroidism. T4 is converted into T3, the active form of thyroid hormone, by two enzymes     called deiodinases. People with hypothyroidism are treated with a synthetic T4 hormone, which     the enzymes convert to T3. This treatment is usually effective, but some people continue to     have symptoms even after treatment. Some researchers think that this may be caused by a     problem with the enzymes that convert T4 into T3. They want to look at how the enzymes     regulate the levels of T4 and T3 in the blood. They will do so by using a drug that blocks     the action of one of the two enzymes.      Objectives:      - To look at how thyroid hormone enzyme blocking affects hypothyroidism treatment medication.      Eligibility:      - Individuals at least 18 years of age who have hypothyroidism and are on thyroid hormone     replacement therapy.      Design:        -  The study consists of one screening visit, 9 days of inpatient hospital admission, and a          follow-up visit 2 weeks after discharge.        -  Participants will be screened with a physical exam and medical history. They will          provide blood samples.        -  Participants will receive balanced-diet meals to take home for the 2 days before they          enter the hospital. They will continue this diet while in the hospital.        -  During the inpatient stay, participants will be monitored with regular blood tests. They          will have the following procedures:        -  Continued thyroid hormone replacement for all 9 days.        -  Drug to block thyroid enzyme for 7 days.        -  Metabolism test, with room temperature changes, on days 1, 2, 5, 8, and 9.        -  Measurements of body fat on days 2, 5, and 8.        -  Blood glucose tests on days 1 and 9.        -  Muscle contraction tests on days 1, 2, 4, 5, 8, and 9.        -  Heart imaging studies on days 2, 5, and 8.        -  Optional skeletal muscle and fat tissue biopsies on days 1 and 9.        -  There will be a follow-up visit 2 weeks after leaving the hospital. Participants will          have a final physical exam and provide blood samples.   "
113444|NCT01801020|"     Introduction: Temperature measurement is a crucial and integral element in the assessment of     the emergency department patients. The basis of triage and treatment is often directly     influenced by temperature measurement. The finding of hyper/hypothermia may differentiate     between a simple urinary tract infection and pyelonephritis, or in more extreme cases may     discern weakness in the elderly from sepsis. This brief encounter of temperature     measurement may be paramount to the medical treatment of the emergency department patient.     The investigators will explore the different modes of temperature measurements in emergency     department patients.   "
113446|NCT01800994|"     ASTHMA:      Asthma is a chronic inflammatory disorder of the airways in which many different types of     cells, and various cellular components. The chronic inflammation causes an increase of the     over-responsiveness of the airways, which leads to recurrent episodes of wheezing,     breathlessness, chest tightness, and coughing, particularly at night or in the early morning     hours. These episodes, usually associated with widespread but variable block the airway,     which is usually reversible either spontaneously or by treatment.      Asthma is one of the most common chronic diseases worldwide, posing significant social burden     in both children and adults. It is estimated that about 300 million people currently suffer     from asthma. The incidence of asthma is universal regardless of the level of development of     the country. There is evidence that over the last 20 years the prevalence has increased     significantly, specially in pediatric populations.      COPD:      Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem. It is the     fourth leading cause of chronic morbidity and mortality in the United States after heart     disease, strokes and acute respiratory infections, while on an annual basis, the disease robs     the lives of more than 3,000,000 people around us worldwide. The most worrying is that the     impact has been steadily rising, and this dramatic increase in the frequency shows that by     2020 the disease will be the third leading cause of death. In Greece, 8.4% of the population     suffers from COPD.      Smoking is the leading cause of COPD. However, not all smokers develop the clinical picture     of COPD, suggesting that additional factors are involved in manifestation. Further     investigation of risk factors for COPD, methods of reducing exposure to these agents and the     molecular and cellular mechanisms involved in the pathogenesis remain a major area of     research to develop effective treatments that will reduce or prevent the development the     disease.   "
113447|NCT01800981|"     Once the victim survived the acute phase, the outcome of wound healing, the scarring, became     a major medical issue with complications that may lead to cosmetic and functional sequelae.     Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface     texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease     function.      Thus, functional and cosmetic outcomes became at least important as wound closure in     assessing wound healing products   "
113448|NCT01800968|"     The primary objective is to test the hypothesis that, compared with placebo, therapy with     Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge     period will be associated with greater clinical stability at six months as assessed by a     composite clinical endpoint.   "
113449|NCT01800955|"     It is a double-blind randomized sham-controlled clinical trial to evaluate the effectiveness     of resistive capacitive diathermy in subjects affected by knee osteoarthritis in comparison     with a sham diathermy treatment. The resistive capacitive diathermy is a medical device     supplying low (448 KHz) radiofrequencies with maximum output power of 200 W, used to reduce     pain and inflammation and allowing healing processes. The sham diathermy treatment is     administered with the device set on on but not active (not supplying energy). Each subject,     randomly assigned to either resistive capacitive diathermy treatment (group 1) or     sham-treatment (group 2) is submitted to a thirty minutes session, three times per week for a     total of ten sessions. The outcome measures are the WOMAC scale (Western Ontario and McMaster     Universities Arthritis Index) to assess pain and physical functioning, a visual analogic     scale (VAS) for pain, the femoral quadriceps strength (MRC = Medical Research Council Scale).     Outcome measures are administered at baseline (T0), at the end of the treatment protocol     (T1), at 1 month (T2) and 3 months (T3) after the end of treatment.   "
113464|NCT01800760|"     The purpose of the study is explore the effect of probiotics on plasma lipopolysaccharides     (LPS) concentrations, as well as insulin and glucose levels, in obese women prior to and     after dietary challenges (high carbohydrate meal, high fat meal).   "
113465|NCT01800747|"     The general hypothesis is that delayed antibiotic treatment strategy present similar     effectiveness, when compared with non-prescription of antibiotics or the prescription of     antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.   "
113476|NCT01800604|"     Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation     (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been     little research on how to treat this pain. Different types of treatment that include     self-hypnosis, education about chronic pain, and learning skills on how to change how a     person thinks about his/her pain have been used to treat chronic pain in the general     population. The purpose of this study is to see if these different treatments can help     decrease pain in people with multiple sclerosis and spinal cord injury, and determine how and     why these treatments are effective. A subject must have a diagnosis of MS,SCI, AMP, MD, or     LBP, have chronic pain, and be at least 18 years old to participate.   "
113450|NCT01800942|"     The last decade has witnessed an important reduction of the mortality in children under 5     years but such reduction has not impacted in neonates. Mortality in neonates contributes 40%     of all deaths occurring in children below 5 years of age.      Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease     follows bacterial infection. Individuals can be infected without developing disease (carriage     stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa,     bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in     all age groups, with the consequence that occurrence of bacterial disease is one of the     highest in the world.      Newborns can be infected during labour - when passing through the birth canal - and during     the first days/weeks of life, as a consequence of the close physical contact with the mother,     if the latter carries bacteria in the nasopharyngeal tract.      If the mother is an important source of bacterial infection to the newborn, treating mothers     with a powerful antibiotic during labour should decrease bacterial carriage and therefore     diminish the risk of bacterial transmission to the newborn during the first days/weeks of     life, which should in turn result in the lower occurrence of severe bacterial disease and     hence lower mortality.      The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin     given to women in labour on bacterial carriage of the newborn as well as the women during the     first month after delivery.      The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has     already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause     mortality when administered to everybody in a community (mass drug administration). This     specific antibiotic has several advantages for being deployable as a simple intervention in     rural Africa, i.e. it requires a single oral administration, it has no special storage     requirements and it has the potential to eliminate many of the bacteria commonly causing     severe disease in newborn.      This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If     an impact is shown, the next step would be to conduct a larger study aiming at establishing     if the intervention, implemented at a lower level of care (most African women deliver at home     assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial     disease   "
113451|NCT01800929|"     The purpose of this study is to evaluate the performance and usability of the N6 system in     children with the N5 system.   "
113452|NCT01800916|"     The aim of the the current investigation is to develop new soft and more flexible 1-piece     ostomy products.   "
113453|NCT01800903|"     The aim of the study is to evaluate safety and performance of a new catheter coating,compared     to the current SpeediCath coating.   "
113454|NCT01800890|"     The aim of the current clinical investigation is to evaluate the performance and safety of     new 2-piece ostomy product concepts.   "
113455|NCT01800877|"     The purpose of this research study is to determine if it is better to give vasopressors to     patients to maintain a higher blood pressure target versus a lower blood pressure target.     This study is important because the information we find out will help us know how best to     administer vasopressors in patients with shock in the ICU.   "
113456|NCT01800864|"     Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are     high in obese subjects indicating resistance to the actions of leptin. High leptin levels     have been associated with increased cardiovascular and metabolic risks, but it is not clear     if increased leptin or leptin resistance contributes to the increased cardiovascular risk.     Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue     functions are not completely investigated in humans. Based on preliminary data the     investigators hypothesize that resistance to leptin action in obese adipose tissue is     responsible for altering the expression of adipose tissue proteins which contribute to the     development of cardiovascular and metabolic dysfunction. To test this hypothesis the     investigators propose a novel study directed at investigating the leptin dependent changes in     adipose tissue protein expression using adipose tissue obtained from lean and obese human     subjects   "
113457|NCT01800851|"     Weight gain is a common complication after transplantation. It has adverse effects such as     hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the     increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved     by a suitable dietary intervention in these patients transplanted kidney can correct lipid     disorders and facilitate balance blood pressure. The identification of mechanisms responsible     for weight gain would suggest prevention strategies and allow to align the caloric energy     needs of renal transplant patients.   "
113458|NCT01800838|"     This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and     photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin     lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes     active when it is exposed to a certain kind of light. When the drug is active, cancer cells     are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma.      Funding Source - FDA OOPD   "
113459|NCT01800825|"     Preterm birth has been linked to certain types of vaginal infections. The goal of this study     is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal     pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate     of preterm birth compared to women given a placebo(starch)   "
113460|NCT01800812|"     Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either     600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural     Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.   "
113461|NCT01800799|"     This study will enroll 30 female patients with the first time urinary tract infection (UTI),     30 female patients with recurrent UTI and 10 female without any prior history of UTI or     urinary tract pathology will be invited to serve as the controls. Urine samples will be     collected in the patients at baseline, 7 days after antibiotics treatment, and 2 weeks, 4     weeks, 8 weeks, and 12 weeks. Urinalysis will be performed at each visit and urine culture     will be performed at baseline and at the 2 weeks and 3 months visits. Urine samples at     baseline and 3 months will be collected from the controls for comparison.   "
113462|NCT01800786|"     The overarching goal of the research proposed here is to test the hypothesis (i) that the     pathophysiological mechanisms of OSA lead to deterioration in sleep-dependent memory     consolidation across memory systems, with the genetic marker APOε4 as a modulator, and (ii)     that CPAP can reverse some or all of these measured memory deficits.      In addition, we are exploring which aspects of OSA (e.g., changes in sleep architecture,     measures of hypoxemia, or the EEG power spectrum) most likely impact sleep-dependent memory     processing.To this end, we are using specific cognitive tasks for which sleep-dependent     memory consolidation processes have previously been demonstrated by our group and others. In     addition, we are carrying out quantitative EEG power spectral analyses, to delineate abnormal     functioning of brain regions with more precision.   "
113463|NCT01800773|"     Although evidence-based treatments for PTSD exist, a significant minority of individuals do     not benefit from these treatments and many individuals to not seek treatment, citing barriers     such as time commitment and expense of treatment. The goal of the proposed study is to     establish an alternative PTSD treatment that is efficacious and efficient.   "
113466|NCT01800734|"     Physiology studies will be performed in patients with type 1 diabetes to define during a     standardized mixed meal test: 1. The relationship between fast insulin analogue     administration by i.v. infusion or by subcutaneous pumps and plasma insulin concentration and     tissue insulin action; 2. The relationship between insulin action, glucose fluxes and glucose     concentration, the latter one as measured in plasma or estimated by a s.c. glucose-sensor; 3.     The concentration curves of some potential modifiers of the glucose-insulin system (i.e.:     glucagon, incretin hormones, free fatty and amino acids).      On the basis of these data, in silico phenocopies of the patients (virtual patients) will be     created to measure the glucose control coefficients, which quantify the role played by each     component of the glucose-insulin system on glucose concentration.      One final purpose of this research is to develop and to optimize an algorithm able to     integrate continuous glucose monitoring with continuous subcutaneous fast insulin analogue     infusion, known as closed-loop control (CLC) or artificial pancreas.   "
113467|NCT01800721|"     The present study includes a randomized clinical trial of a peer health education     intervention and a 12-month longitudinal study. The sample will include Black Men who have     Sex with Men (MSM) who will be randomized into an experimental or control condition and then     asked to recruit peer and risk network members for HIV testing over a 3 month period. Some of     the network members who are recruited for voluntary counseling and testing (VCT) will enroll     into the longitudinal study for assessments only. Both index and network participants will be     assessed at baseline, 6, and 12-months.      The specific aims of the proposed study are to:        1. Train Black MSM (index participants in the experimental condition) to conduct peer          health education, to promote VCT and HIV risk reduction among social network members,          and to recruit social network members for VCT.        2. Examine changes in HIV risk behaviors and VCT among index participants and their network          members in the experimental intervention as compared to those in the control condition.        3. Examine mediating effects of social environments (networks, social norms) on HIV risk          behaviors and VCT, among indexes and network members.        4. Examine mediating effects of individual level factors (substance use and depression) on          HIV risk behaviors and VCT among indexes and network members.   "
113468|NCT01800708|"     The aim of the present study is to investigate the outcomes of congenital cataract surgery     when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral     prednisolone.      This is a prospective, randomized clinical trial. Sixty children will be submitted to     congenital cataract surgery younger than 2 years of age. They will be randomly divided in two     groups. The study group will receive an intraoperative intracameral triamcinolone acetonide     injection. The control group will receive prednisolone syrup postoperatively. The surgical     outcomes will be assessed after one year.   "
113469|NCT01800695|"     This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with     glioblastoma multiforme.   "
113470|NCT01800682|"     The purpose of this study is to evaluate the dose proportionality of the pharmacokinetics     (explores what the body does to the drug) of tramadol in healthy adult participants.   "
113471|NCT01800669|"     The investigators hypothesize that by adding a patient screening and physician alerting     module to a computer-based decision support system, the investigators can improve the     detection and management of legal issues that may affect children's health. this randomized     controlled trial will place the module in two clinics using the CHICA decision support system     and compare the rate of detection and resolution of medical-legal issues in those clinics     compared to two clinics using the CHICA system without the medical-legal module.   "
113472|NCT01800656|"     The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy     interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2)     safety and feasibility of endoloop assisted snare polypectomy in patients with long-term     antiplatelet therapy; 3) safety and feasibility of so called ligate and let go approach in     patients with long-term antiplatelet therapy.   "
113473|NCT01800643|"     The purpose of this prospective study is evaluate the best dose of busulfan for each patient     undergoing Haematopoietic Stem Cell Transplantation   "
113474|NCT01800630|"     Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients     each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation     (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and     12 of 4 21-day cycles each to further characterize safety and tolerability.   "
113475|NCT01800617|"     The purpose of this study is to test a new thyroid hormone preparation. The thyroid gland     produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy     for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a     synthetic form of T4. T4 is converted into the active hormone T3 in the circulation.     Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly     lower than in individuals whose own thyroid gland is functioning normally. Symptoms of     hypothyroidism have been suggested to occur because of this possible T3 deficiency, although     this is controversial. Studies of T3, added to or substituted for T4 in traditional     levothyroxine regimens, have generally not shown any benefit of T3. However, it is still     possible that no benefit is seen because of the short duration of action or half-life of     T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite     multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and     troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels.     This study will look at TSH and thyroid hormone levels following a daily dose of a new     preparation of T3 that may have longer duration of action than liothyronine. This preparation     of T3 is called Thyromax® or BCT303. The investigators believe that steady levels of T3 will     be seen after taking Thyromax®. The investigators believe that in patients with     hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels, without     producing symptoms of too much thyroid hormone. The goal of future studies is to test whether     Thyromax® may be a potential treatment for hypothyroidism, by comparing it with traditional     levothyroxine therapy.   "
113563|NCT01799460|"     The purpose of this study is to analysis the different genotype in the idiopathic membranous     nephropathy patients which with different therapeutic outcomes after treated by the     Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal     markers to assess appropriate treatment approach and the long-term efficacy.   "
113479|NCT01800565|"     Precocious puberty (PP) in girls is classically defined by the onset of secondary sexual     characteristics before eight years of age, but subsequent pubertal maturation can be quite     varied. In many girls, PP takes a rapid course of progression (rapidly progressive precocious     puberty; RP-PP) with an early menarche and fusion of the epiphyseal growth plates, leading     eventually to a reduced final height if not treated. In a subset of girls with PP however,     the growth rate slows to normal for age, skeletal maturation progresses in accordance with     chronological age and there is little to no risk of impairment of final height (slowly     progressive precocious puberty; SP-PP). Other conditions of non-progressive PP include     premature breast budding and unsustained PP that is characterized by a spontaneous regression     of sexual precocity. Due to their benign course, slowly progressive (SP) PP and other     non-progressive forms of PP do not warrant therapy with GnRH agonists. Differentiating these     forms from RP-PP is therefore essential to prevent unnecessary intervention in a population     that accounts for at least 50% of girls with PP. A distinction between these forms of PP may     be difficult on clinical grounds however, since all these patients may present initially as     isolated breast development.      The gold standard for the diagnosis of true (central) PP is the measurement of gonadotropins     following GnRH stimulation test. There is however an overlap between prepubertal and early     pubertal values and between girls with premature breast budding and progressive PP. It was     suggested therefore that progressive pubertal development and growth acceleration should be     documented over a 3- to 6-months period before GnRHa therapy in initiated.      More than a decade ago several studies demonstrated that urinary gonadotropins are age     related and significantly increased during puberty. It has been suggested that urinary     gonadotropins measurements can be used for differential diagnosis of pubertal disorders. This     is based on the assumption that gradual elevation of nocturnal LH secretion prior to and at     the onset of puberty can be reflected by first-voided urinary LH (ULH). In this prospective     study, the investigators aimed to evaluate the value of first-voided ULH measurements in     predicting pubertal course and differentiating SP-PP from RP-PP, by comparison to     GnRH-stimulated gonadotropins.   "
113480|NCT01800552|"     The purpose of this study is to determine whether commercial ultrasound imaging systems can     discern normal from infiltrated tissue near a peripheral intravenous site.   "
113481|NCT01800539|"     Based on the need to characterize and improve early intervention services for minority and     under-resourced children with ASD, this study translates a manualized and proven training     model to examine its impact on the use of evidence-based practices (EBP) by early     intervention providers, and to examine its relationship to child and family outcomes. By     highlighting the impact of EBP-focused training on participating providers, children, and     families, findings of the proposed study have the potential to effect significant change in     the organization and delivery of early intervention services for minority and under-resourced     children with ASD.   "
113482|NCT01800526|"     Part 1: A pilot study in patients with homozygous S (HbSS) or hemoglobin S with beta zero     thalassemia(HbS-βo thalassemia), with the aim of examining the effect of intravenous NAC     treatment on plasma VWF parameters and measures of redox and RBC function.      Part 2: A pilot study in patients with sickle cell disease admitted to the hospital in     vaso-occlusive crisis to determine the effects of NAC infusions on plasma VWF parameters and     measures of redox and RBC function, and on measures of pain and hospital length of stay.   "
113483|NCT01800513|"     This proposed research is a single center, prospective, single-blinded, randomized controlled     trial, designed to evaluate IVF pregnancy outcomes following endometrial injury in 254     patients with implantation failure. Patients will be identified during their work-up and     treatment at Shady Grove Fertility Reproductive Science Center. Only Shady Grove patients are     eligible for the study. The investigators hypothesize in patients with one or more previous     failed day 5 blastocyst transfers, injury to the endometrium via endometrial biopsy will     improve clinical pregnancy outcomes compared to controls.   "
113484|NCT01800500|"     This randomized clinical trial studies interest in smokeless tobacco product as a     substitution for cigarettes in current smokers. Use of smokeless tobacco products may help     people stop smoking. Measuring use of other sources of nicotine for cigarettes under a     variety of different conditions may help determine whether and how much smokers are willing     to use substitutions   "
113485|NCT01800487|"     Hepatitis is one of the most common adverse effect from anti-tuberculosis. Silymarin showed     its efficacy to decreased serum alanine transaminase enzyme in animal models from recent     study. No confirmed this efficacy was performed in human.      A prospective, double-blind, placebo-controlled trial was carried out according to Good     Clinical Practice Guideline. This study is to define the efficacy of silymarin to prevent     hepatotoxicity from anti-tuberculosis drugs. Informed consent is obtained prior to the study.     New patients diagnosed with tuberculosis are enrolled. Patients with liver diseases, current     alcohol drinking more than 20 g/day, regular use of herbal or other potential hepatotoxic     drugs are excluded. Patients are treated with a standard regimen of four anti-tuberculosis     therapy. They will randomize to receive either placebo or silymarin (140 mg) thrice daily.     Liver function test (LFT) and clinical changes are assessed at 2- and 4-week after initiation     of the treatment. DILI from anti-tuberculosis drugs ('atb-DILI') is defined as: i) a rise of     alanine aminotransferase (ALT) to 2 times above normal upper limit, or ii) an elevation of     total bilirubin more than 2 mg/dl with or without ALT elevation. The study endpoints are the     level of ALT by week 4 and the number of patients who developed atb-DILI.      Statistical analysis is used to compare the differences in ALT and number of atb-DILI   "
113486|NCT01800474|"     A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice   "
113564|NCT01799447|"     Early intervention with the Marte Meo method. Aim to study whether the program have effect     on:      Maternal confidence, maternal stress, maternal mood (EPDS), dyadic synchrony (Infant care     index), and infants social competences (ASQ:SE)   "
113487|NCT01800461|"     Participation in valued activities following stroke is a recognized problem. Efficient and     effective interventions to address this problem have not yet been established although the     literature provides direction as to the needs of stroke survivors and important parts of     interventions to address these needs. Occupational Performance Coaching (OPC) is an emerging     approach to enabling occupational performance or participation in valued activities that     includes these important parts of interventions. The primary goal of OPC is ability and     satisfaction with participation in chosen activities, while promoting a client's ability to     address future problems with participation. OPC has been successfully used with parents and     their children in addressing problems with participation.      OPC has not been explored among adults who have experienced a stroke. For this study     OPC-Stroke (OPC adapted for stroke survivors) will be tested to explore its potential     effectiveness for increasing participation as well as how feasible and acceptable the     research methods are. Sixteen participants who receive OPC-Stroke will be compared with     sixteen who do not using measures of participation, goal achievement, well-being,     self-efficacy and cognition. Those who receive OPC-Stroke will also be interviewed about     their experience of the treatment.   "
113488|NCT01800448|"     For critically ill patients, it is important to know when to liberate them from mechanical     ventilation (the removal of breathing or endotracheal tube or extubation) and weaning (the     progressive decrease of the amount of support that a patient receives from the mechanical     ventilation). It is well recognized that prolonged ventilation and weaning harms patients and     introduces significant increased costs to the health care system. The investigators objective     is to improve the safety of removal of life support in critically ill patients by harnessing     information from two new technologies; NM3 and Nexus device. In particular, the investigators     are interested in the patterns of variation of respiratory and cardiac signals from the NM3     device, as well as monitor skin conductance with the Nexus device. The combination of these     measures has not yet been investigated to date, and could represent a novel set of measures     that can be used to help physicians better manage critically ill patients. The current     standard of care dictates that once a patient is considered as a candidate for withdrawal     from ventilation, a spontaneous breathing trial (SBTs) is performed, where the degree of     ventilator support is decreased, and their response is observed to help predict if they will     tolerate extubation.      Health is associated with a high degree of variation of physiologic parameters such as heart     rate and respiratory rate, and illness & stress are associated with a loss of variability.     The analysis of variability of biological signals measures the degree of fluctuations present     over time. Previous studies have demonstrated that changes in variability (generally     decreases) are observed in illness states, and the degree of this change correlates with     illness severity. Several studies have reported that reduced heart or respiratory rate     variability (HRV or RRV) during SBTs is associated with extubation failure. Until recently,     variability analysis has traditionally been done only on heart rate (HRV), derived from     analyzing beat-to-beat intervals from the ubiquitous electrocardiogram (ECG). The     investigators aim to apply variability analysis to the respiratory and cardiac signals which     represent a rich novel set of muti-organ variability measures whose utility in managing     extubation and ventilator weaning has not been investigated to date.   "
113489|NCT01800435|"     Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII     (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients     with high titer inhibitors. However, management of bleeds in these patients can be     challenging due to variation in response and lack of standardized methods to monitor the     effect. We hypothesized that significant increase in whole blood clot stability could be     achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin     generation remains unaffected. In this prospective crossover study the effect of aPCC and     rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were     studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively.     In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was     assessed.   "
113490|NCT01800422|"     The purpose of this study is to determine whether or not the medication that blocks the     effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of     breast cancer cells as compared to a placebo. CDB-4124 (also called Proellex) is a medication     that works against the hormone, progesterone. The researchers in this study would like to     compare changes in breast cancer cells of women who have taken CDB-4124 prior to surgery to     those from women who have taken a placebo pill prior to surgery.   "
113491|NCT01800409|"     Compromised respiratory function as a result of tetraplegia is a leading cause of     rehospitalisation for the tetraplegic patient group. Electrical stimulation of the abdominal     muscles has previously been used to improve the respiratory function of tetraplegic patients     in the chronic stage of injury. In this study the investigators aim to evaluate the optimum     protocol for the use of electrical stimulation of the abdominal muscles to improve the     respiratory function of the tetraplegic population. The investigators also aim to investigate     whether abdominal functional electrical stimulation combined with mechanical     insufflation-exsufflation can be used to help further improve the respiratory function of the     tetraplegic population.   "
113492|NCT01800396|"     Background: The incidence of gastrointestinal infections is very high. In Western countries     at least 30% of the population suffers from at least one food-borne infection per year.     Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of     infections. One of the possibilities is to strengthen human resistance to gut infections by     consumption of milk ingredients.      Aim: To study whether a milk protein concentrate rich in phospholipids improves the     resistance of humans to enterotoxigenic E. coli (ETEC).      Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks     intervention with a milk protein concentrate rich in phospholipids in healthy subjects of     18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate rich     in phospholipids or placebo group (n=30 per group). Subjects will be instructed to maintain     their usual pattern of physical activity and their habitual food intake, but to standardize     their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally     infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food     research; dose will be 1010 CFU). Before and after infection, an online diary will be kept to     record all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The     diary will also be used for daily recording of bowel habits and frequency and severity of     gastrointestinal complaints.      The following biological samples will be collected: 4x10 ml venous blood, a single fecal     bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and     the fecal samples are collected to quantify several infection- and immune system markers and     to verify dietary calcium intake. Saliva is sampled three times before and after infection to     quantify immune system markers.      Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output     per day).      Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and     gastrointestinal complaints, relative fecal wet weight.   "
113509|NCT01800175|"     The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug     when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in     order to assess retention and replacement of the OTX Punctum Plug for this duration. At the     Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial     OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180 and     270, the subject will again receive a new OTX Punctum Plug after the previous OTX Punctum     Plug is removed.   "
113565|NCT01799434|"     The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg     standing and in jump landing, followed by stabilization or side jumps, and to compare     athletes of different levels with control subjects.   "
113502|NCT01800266|"     The primary goal of this study is to examine the impact of varying supervision strategies on     clinician fidelity and client outcomes in a community-based setting. Prior research has     established that training approaches that do not include a period of intervention-specific     supervision or consultation are ineffective and that implementation efforts that include only     an initial period of supervision show an eventual attenuation of gains in knowledge and     fidelity in practice. Ongoing supervision may be required for effective and sustained     implementation of evidence-based practices (EBPs) in community-based settings. However,     supervision is one of the least investigated aspects of training. Gold standard elements of     supervision from efficacy trials include review of sessions, standardized procedures for     monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral     rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in     community-based settings is unknown.      There are a growing number of national and statewide efforts to increase the reach of EBPs     through dissemination and implementation initiatives. There are 18 statewide initiatives to     implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma     exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those     for other EBPs, include a specific focus on supervisors. However, the limited scientific     literature provides very little guidance for these efforts. Aims of the current trial include     1) studying supervision with existing implementation supports; particularly presence of gold     standard elements; 2) evaluating the effects of varying supervision strategies on fidelity     and client outcomes; and 3) testing the mediating effect of treatment fidelity on the     relationship between supervision type and client outcomes. We propose a two-phased,     within-subjects and between subjects design. In Phase I (9 months), we examined supervision     with implementation support. In Phase II (30 months), we will examine two specific     supervision conditions, each including varying EBP supervision elements.   "
113493|NCT01800383|"     Posttraumatic stress disorder (PTSD) is a common and debilitating neuropsychiatric disorder     in which an acute fear response to a traumatic event does not abate. This failure to recover     from trauma is thought to be due at least in part to a deficit in learning not to fear     situations and stimuli previously associated with the trauma (i.e., specifically due to a     failure of extinction recall). Pavlovian fear conditioning can be simulated and measured     experimentally in humans using a 2-day fear conditioning paradigm developed by our group,     wherein conditioning and extinction learning phases are conducted on Day 1, and extinction     recall is tested on Day 2.      Recent functional magnetic resonance imaging (fMRI) evidence indicates that PTSD is     associated with hyper-responsivity of the insular cortex and hyporesponsivity of the     ventromedial prefrontal cortex (VMPFC) during exposure to fear-inducing stimuli, consistent     with altered excitability of brain regions mediating fear conditioning and extinction. As the     brain's principal inhibitory neurotransmitter, GABA exerts a prominent role in modulating     neuronal excitability. Interestingly, there are reports that adjunctive treatment with     GABA-enhancing antiepileptics is efficacious in PTSD. There is also evidence, albeit     inconsistent, that lower serum GABA levels predict a more chronic course of the illness.     However, it is unclear whether serum levels accurately reflect brain GABA, which may     contribute to inconsistency of serum findings. Moreover, it is possible that GABA alterations     may vary in their presence, nature and significance across brain regions implicated in PTSD.     The proposed study will examine the relationship of PTSD symptoms and behavioral fear     conditioning deficits with regional brain gamma-aminobutyric acid (GABA) using proton     magnetic resonance spectroscopy (1H-MRS).      We have the following aims and hypotheses:        1. To determine whether GABA alterations are associated with the categorical diagnosis of          PTSD and not merely exposure to trauma. It is hypothesized that PTSD will be associated          with higher GABA in VMPFC and lower GABA in the right insula.        2. To determine whether GABA levels are significantly associated with dimensional measures          of PTSD symptom severity and individual symptom dimensions. It is predicted that higher          GABA in the VMPFC and lower GABA in the right anterior insula will be associated with          greater total symptom severity.        3. To determine whether GABA in VMPFC and right anterior insula are significantly          associated with measures of extinction recall failure and anxiety sensitivity in PTSD.          It is hypothesized that VMPFC GABA will be positively correlated with skin conductance          response to a conditioned stimulus that had previously been extinguished and insula GABA          will be negatively correlated with anxiety sensitivity.   "
113494|NCT01800370|"     Aging in men reduces the amount of luteinizing hormone (LH) and testosterone (Te) secreted in     each burst. Stress-associated mechanisms introduced by acute illness and chronic disease     decrease LH and Te secretion further. A major unresolved issue is whether the aging process     heightens the negative effects of a stressor (whether physical or metabolic) upon LH and Te     secretion. This study will assess LH and Te secretion in response to a physical stressor     (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in     healthy men ages 18-80 yr.   "
113495|NCT01800357|"     This study seeks to evaluate the efficacy and safety of mildronate injection in treating     acute ischemic stroke   "
113496|NCT01800344|"     The study compares the incidence of pharyngolaryngeal complications in patients managed with     either a pressure-limiting strategy using the AES Ultra CPVTM or a standard practice using a     LMA, in ambulatory surgery patients.   "
113497|NCT01800331|"     In Canada, the number of obese children and adolescents has increased tremendously.     Interventions addressing diet and physical activity have been successful in the short-term.     However, a great number of individuals have difficulties maintaining achieved weight loss and     returning to treatment sessions.      New technology interventions, through the web or delivered trough Personal Digital Assistants     (PDAs) (e.g. iPhone or Blackberry), are increasingly being used in health interventions. PDAs     have emerged as appealing in health interventions as they are easily accessible and their     interactivity makes them well suited to promote long-term engagement in behaviour change     interventions.      This study will look at the utility of supplementing a family-based lifestyle program for     overweight and obese adolescents (Shapedown BC) with a PDA intervention (Text2bHealthy)     focussing mainly on physical activity, sedentary behaviours, and dietary intake to maintain     treatment success by improving self-management skills. Adolescents and will receive     Text2bHealthy for 3-months after 3 months participation in the Shapedown BC program.      Results from this study will provide needed information on how to improve treatment adherence     and maintenance outcomes through the use of innovative methods and will ultimately contribute     to the improvement of long-term outcomes in obesity treatment.   "
113498|NCT01800318|"     The purpose of the study is to determine whether noninvasive electrical stimulation at     acupuncture points (NESAP) and/or 24% sucrose is effective in reducing pain in infants during     invasive procedures.      The investigators hypothesize that:        -  Gentle noninvasive electrical stimulation at selected acupuncture points and/or oral use          of 24% sucrose with pacifier will reduce the newborn infant's responses to heelstick          pain, as measured by the Premature Infant Pain Profile (PIPP), heart rate variability,          duration of crying, and salivary cortisol levels.        -  The effects of combined therapies will be additive.        -  The analgesic effects of NESAP and/or sucrose will continue for the duration of the          heelstick, reflected by the first two minutes of heelstick and the first two minutes of          recovery.   "
113499|NCT01800305|"     The object of this randomized, parallel, positive controlled study is to explore the     pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous     administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous     administration, by assessing plasma concentration of the drug and the reticulocyte count,     hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the     security and tolerability of the test drug in healthy subjects, and provide sufficient     information for dose selection in the future phase II and III study.   "
113500|NCT01800292|"     The purpose of this study is to determine if patients with pulmonary hypertension and mildly     elevated heart pressure known as PCWP will exhibit different patterns on echocardiography and     that these patterns will predict treatment response to sildenafil, a drug given for this     condition.   "
113501|NCT01800279|"     The purpose of this study is to determine whether kinesitherapy techniques and a myofascial     therapy protocol are effective in the treatment of temporomandibular joint dysfunction in     patients with fibromyalgia syndrome.   "
113510|NCT01800162|"     This is a randomized controlled trial to compare three currently available management     strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them     at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed     PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by     methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy)     2) Empiric treatment with MTX for all, and 3) Expectant management. Randomization will be     2:2:1 into these three arms. After randomization, they will be followed and treated     clinically as is indicated by the progression of their condition. Primary outcome measures:     uneventful decline of hCG to 5 IU/mL. Secondary outcome measures: re-interventions, treatment     complications, health-related quality of life, financial costs, future fertility, and     patient's preferences.   "
126831|NCT01624961|"     The study is designed to establish the best dose to safely infect healthy individuals with     Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.   "
113504|NCT01800240|"     Objective:      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride     and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone     hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals     America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, and Open-Label   "
113505|NCT01800227|"     Objective:      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride     and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone     hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals     America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, and Open-Label   "
113506|NCT01800214|"     The prospect of disease-modifying therapies in the pipeline for Alzheimer's Disease (AD) has     intensified efforts to use brain imaging more effectively for diagnosis and monitoring of     dementing illnesses. There is also emerging awareness of the destructive interplay between AD     and Cerebrovascular Disease (CVD) in our aging population; both disorders share common     vascular risk factors and may respond to similar prevention treatments. Brain mapping     techniques capitalize on the fact that different neurodegenerative diseases target particular     brain areas. Brain shrinkage and stroke disease can be quantified on Magnetic Resonance     Imaging (MRI) using computerized analysis.      This ongoing study applies advanced MR imaging analysis, genetic testing and standardized     cognitive and functional assessments done at yearly intervals to measure and monitor     longitudinal change in patients with AD, vascular and other neurodegenerative diseases and     potentially to measure modifying effects of emerging therapies. Over 1000 patients (Mild     Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and     125 normal elderly have already been enrolled, with 150 autopsies.      This study utilizes specialized imaging analysis software packages to reliably quantify brain     tissue volumes and small vessel disease, the most common type of CVD. Results from this study     will help to improve diagnosis, to customize treatment, and to better monitor     disease-modifying therapies currently under investigation should they become applicable to     everyday practice.   "
113507|NCT01800201|"     The goal of this proposal is to test the implementation of an innovative approach to     improving health and lowering cost for a high risk population of patients with acute     myocardial infarction (AMI) immediately post-hospitalization. The investigators will     implement a new service delivery approach that will provide a foundation for a payment system     that rewards keeping high-risk patients healthy and that deploys technology and a health care     workforce of the future to implement prevention, care coordination, care process     re-engineering, team-based care, and the use of data to support new care delivery models.     This program is focused on coronary artery disease (CAD), but we expect that a successful     implementation of this model will demonstrate a sustainable pathway to the three-part aim not     just for CAD, but for many other conditions whose outcomes are highly sensitive to     post-discharge coordination.      This proposal has three main principles:        1. Principles of behavioral economics that have been developed, refined, and tested over          the past decade offer practical insights into health behaviors that were previously          unavailable and are not reflected in existing care models.        2. New technology, typically wireless devices for pill bottles, and mobile telephones, make          engagement with patients substantially easier and more immediate now than ever before.        3. While randomized clinical intervention trials provide exceptional confidence of          comparative effectiveness in narrow interventions, they are slow and rigid and dont          reflect the urgency that health care transformation currently requires. Principles of          rapid cycle innovation are gaining acceptance as an alternative to or supplement of          these traditional methods in supporting evidence for implementation success.   "
113508|NCT01800188|"     Disturbed glucose metabolism is a common feature of patients with end-stage renal disease     (ESRD). Several hormones responsible of a stable blood glucose including insulin, glucagon,     and the gastrointestinal insulinotropic hormones Glucagon-like Peptide-1 (GLP-1) and     Glucose-dependent Insulinotropic Peptide (GIP) are elevated in patients with ESRD. These     hormones are all medium sized peptides which theoretically makes them removable during high     efficient hemodialysis. A significant removal could have consequences for the treatment of     patients with diabetes and ESRD.      The purpose of this study is to determine whether insulin, glucagon, GLP-1 and GIP are     cleared during high efficient hemodialysis and hemodiafiltration. The investigators     hypothesize that a significant amount of these hormones is removed during hemodialysis and to     a larger extend during hemodiafiltration.   "
113531|NCT01799876|"     The purpose of this study is to assess the potential benefit of enhancing knee surgery for     cartilage injury using some of the patient's own cells, taken from fat tissue, that may be     able to help cartilage to regenerate.   "
113511|NCT01800149|"     Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a     collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive     adult patients, requiring tooth extraction in the frontal area of the upper and lower arch     maxilla (from second premolar to second premolar), will be enrolled into the study.      After tooth extraction, sockets will be randomized and divided into two groups: in Group A     the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted     with BioOss granules (small granules). The graft will be covered with porcine collagen     membrane (BioGide). Then, the flap will be sutured.      MEASUREMENTS:      The end of the study will be fixed at the 6 months evaluation after tooth extraction.     Impression will be taken before tooth extraction and after 6 months in order to create cast     models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal     dimension of the soft tissues will be measured. One measurement per tooth will be recorded,     at T0 (before extraction) and T2 (after 6 months).      A 3D radiological image, using the CBCT technique, will be obtained at the end of the     surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition     will be performed in order to measure hard tissue remodelling.      After six months (T6), a a biopsy specimen will be also harvested for that augmented     extractions sockets on which an implant installation has been previously planned.   "
115734|NCT01770977|"     Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in     experimental models and human researches. Now, the investigators used LEDT to increase muscle     performance of professional athletes with high performance.   "
113512|NCT01800136|"     The aim of this study is to compare analgesic efficacy of two non invasive techniques based     on motor cortex stimulation in neuropathic pain patients. High frequency repetitive     transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to     induce an analgesic effect significantly different from placebo; this effect is clinically     useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct     current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its     efficacy in neuropathic pain has been not yet established. The investigators propose to     compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using     HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed     before and after the five sessions of rTMS and tDCS, in order to reveal the potential     plasticity induced within motor somatotopic map of the primary motor cortex.   "
113513|NCT01800123|"     There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital     signs or lactatemia have failed to prove good predictive value.      The main acute self poisoning complication is decreased consciousness level with consequent     increased risk of hypoxemia and aspiration pneumonitis.      Several clinical studies have recently shown that EtCO2 monitoring can be valuable in     procedural sedation in the emergency department. It is able to predict hypoxemia before any     SaO2 decrease and any complications related to these procedures.      We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring     in the ED.   "
113514|NCT01800110|"     Many medicinal effects of Pomegranate juices are already known. Mainly known for its     anti-viral, anti-bacterial and anti-oxide tendency of pomegranate juice.      Many studies which have demonstrated antioxidant activity of pomegranate juice in the blood     and blood cells were published.      In addition, published studies have demonstrated the anti-oxidant activity which inhibit the     development of atherosclerosis and stroke, even in patients with diabetes, and its effect of     decreasing systolic blood pressure in patients with systemic hypertension.      The purpose of the work is to examine the effect of drinking pomegranate juice on the level     of anti-oxidants in human breast milk.   "
113515|NCT01800097|"     This study is an investigator initiated placebo controlled double blinded trial. The     hypothesis is that treatment with modafinil positively will affect behavioural and cognitive     rehabilitation after stroke, causing the treatment group to experience decreased fatigue,     increased endurance, improved skills of sustaining attention and faster reaction times. The     cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and     better physical performances due to a higher level of physical activity.   "
113516|NCT01800084|"     The main objective of this study is to demonstrate the non-inferiority of SPECT image quality     (as measured by the signal / noise ratio) obtained by ASIR reconstruction of very-low-dose CT     acquisitions versus the quality of those obtained by filtered back projection (FBP) of     low-dose CT acquisitions.      The lower limit of non-inferiority is set to -1, the average SPECT signal / noise ratio TEMP     expected is between 5 and 6.   "
113517|NCT01800071|"     This clinical study is looking at a vaccine called MVA-EBNA1/LMP2. This is a new vaccine that     has already been studied in small number of cancer patients.      The vaccine is designed to boost a patient's immunity against a common virus. The virus is     called Epstein Barr virus or EBV. EBV is sometimes found inside cancer cells and is commonly     found in nasopharyngeal cancer cells.   "
113518|NCT01800058|"     The detection and quantification of Circulating tumor cells CTCs in peripheral blood of     patients with prostate adenocarcinoma may be useful at least for:      Getting a correct stratification of patients with high-risk prostate cancer (PCa).      Set the prognosis at baseline. Evaluate the response to different treatments (predictive     value and monitoring).      Establish individualized therapies.   "
113519|NCT01800045|"     Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic     patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks     per week).      The patients will be treated during 7 weeks with Pitolisant or placebo.   "
113520|NCT01800032|"     This prospective pilot study is designed to provide preliminary data on the use of     Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) in     patients with neurofibromatosis-1 (NF1) associated optic glioma and plexiform neurofibroma     (PN).      Subjects will undergo FDG-PET-MRI scans in place of standard of care imaging at 0 and 12     months, unless more frequent imaging is clinically indicated. Subjects and their family     caregivers will also undergo serial interviews and complete questionnaires related to the     psychosocial aspects of NF1.   "
113532|NCT01799863|"     The purpose of this study is to evaluate the evolution of the symptoms of acute viral     conjunctivitis using preservative free ketorolac trometamol 0.45% associated with     carboxymethylcellulose compared with isolated use of preservative-free artificial tears.   "
113533|NCT01799850|"     Subjects with type 2 diabetes will be treated with Actos or placebo for eight weeks and     needle biopsies of muscle will quantify changes in any of seven different glucose transport     proteins in muscle.   "
113521|NCT01800019|"     The objectives of this trial are:      Primary objectives:        1. To determine among HIV+ individuals whether varenicline or NRT is more effective at          helping individuals remain abstinent from smoking tobacco.        2. To determine among HIV+ individuals whether varenicline or NRT has the lowest          side-effect profile.        3. To determine if the HIV tailored Quit Smoking Counselling Intervention, plus smoking          cessation drug therapy, improves smoking cessation rates compared to smoking cessation          drug therapy alone with usual care.      Secondary objective:      1. To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit     depressive symptoms.      Hypothesis:      That varenicline will result in higher quit smoking rates and that NRT will result in a lower     side effect profile. Further, the HIV tailored quit smoking intervention will result in     higher rates of smoking cessation over and above the pharmacological treatment alone. And     finally, varenicline will be safe to use for HIV + individuals who exhibit depressive     symptoms.   "
114146|NCT01791777|"     The proposed study will compare purveyor coaching (conducted by National SafeCare Training     and Research Center (NSTRC)) to local coaching that is supported by the purveyor (NSTRC). The     outcomes of interest are home visitor fidelity and competence with the SafeCare model, and     family engagement and skill acquisition. The study will also include a rigorous cost     effectiveness analysis, and will examine individual and organizational factors that may     affect implementation.   "
113522|NCT01800006|"     This international study is a prospective noninterventional observational cohort study of     patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine     treatment conditions to prevent stroke or non-central nervous system systemic embolism.     Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in     case of therapy was discontinued earlier than 12 months. Serious adverse events will be     followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented     for each point in time they were measured.   "
113523|NCT01799993|"     To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg     (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System     (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal     saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and     mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint     objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized     placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on     ventilation, and the days in the intensive care unit (ICU).   "
113524|NCT01799980|"     This study will compare two different methods of staging lung cancer to determine whether     endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good     diagnostic yield in detecting lung cancer, when compared to current methods of a staging     bronchoscopy and cervical mediastinoscopy.   "
113525|NCT01799967|"     This study will assess short and long term outcomes of individuals undergoing minimally     invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to     questionnaires on an annual basis evaluating quality of life and functionality following     MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health     outcomes.   "
113526|NCT01799954|"     This study will evaluate the safety of and the body's immune response to experimental HIV     vaccine regimens using different vaccine priming combination, and boosting with the vaccines     NYVAC and AIDSVAX® B/E.   "
113527|NCT01799941|"     The objectives of the study are to evaluate the safety, tolerability, and effectiveness of     NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of     Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and     traumatic brain injury (TBI)over a 12 week period.   "
113528|NCT01799915|"     Synucleinopathies are a group of rare diseases associated with worsening neurological     deficits and the abnormal accumulation of the protein α-synuclein in the nervous system.     Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present     clinically with slowness of movement, coordination difficulties or mild cognitive impairment.     Development of these features indicates that abnormal alpha-synuclein deposits have destroyed     key areas of the brain involved in the control of movement or cognition. Patients with     synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease     (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA).      However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the     brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms     of autonomic impairment (unexplained constipation, urinary difficulties, and sexual     dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic     hypotension) may be the only clinical finding. This pre-motor autonomic stage suggests that     the disease process may not yet have spread to the brain.      After a variable period of time, but usually within 5-years, most patients with abnormally     low blood pressure on standing develop cognitive or motor abnormalities. This stepwise     evolution indicates that the disease spreads from the body to the brain. Another indication     of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem     that occurs when the lower part of the brain is affected, may also be the first noticeable     sign of Parkinson disease.      The purpose of this study is to document the clinical features and biological markers of     patients with synucleinopathies and better understand how these disorders evolve over time.     The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA)     and those believed to be in the pre-motor stage (with isolated autonomic impairment and/or     RBD). Through a careful series of follow-up visits to participating Centers, we will focus on     finding biological clues that predict which patients will develop motor/cognitive problems     and which ones have the resilience to keep the disease at bay preventing spread to the brain.     We will also define the natural history of MSA - the most aggressive of the     synucleinopathies.   "
113529|NCT01799902|"     This study is a non interventional study where no investigational medicine is provided.     Procedures and examination will follow the institution standard of care practice. The     therapeutic approach will not be decided in advance by the protocol or influenced in any way     by the protocol.      After standard evaluation the investigator will decide the treatment strategy and upon     eligibility criteria met will propose subject to participate to the study. Informed consent     will be collected for all subjects.      The study will consist of 3 possible observational visits; V1 (enrolment), V2 and V3 (follow     up).      During all observational visits (V1, V2 and V3) the patient will complete the I-PSS     (International Prostate Symptom Score) questionnaire including Quality Of Life (QOL)     questionnaire and a Patient assessment of treatment benefit and satisfaction using a Visual     Analogue Scale (VAS).      The patient will be asked to complete a voiding diary the first 3 days after Visit 1     (Baseline diary), 3 days before Visit 2 and again 3 days before Visit 3.      Prostate Specific Antigen (PSA) measurement- Uroflowmetry - Post Voiding Residual volume and     Trans Rectal Ultra Sound data will be collected only if available.      During all observational visits (V1, V2 and V3) the investigator will complete the assessment     of treatment benefit and satisfaction using a VAS.   "
113530|NCT01799889|"     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of     entospletinib. Participants with the following relapsed or refractory hematologic     malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic     leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular     lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid     lymphoma/ Waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or     marginal zone lymphoma [MZL]).   "
113543|NCT01799720|"     The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be     a serious problem for manufacturers and a risk to consumers; health by ingesting substances     whose effects are not desired. Therefore, the main objective of this paper is to analyze the     effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile     of women who consume these supplements. For this purpose the investigators have designed a     single-blind, parallel-groups, randomized controlled trial. Finally, 52 women between 25 and     75 years old were randomly distributed into three groups: (1) took 2 capsules/day of one of     the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2) took 2 capsules/day of one     of the most oxidized oil (containing 300 mg EPA + DHA) and diet and (3) no capsules, only     received the diet. There was a 30 days follow-up . All groups followed a low cholesterol     diet. Circulating glucose, total cholesterol, triglycerides and glutamic pyruvic transaminase     were determined at the beginning and end of a 30 day period.   "
113534|NCT01799837|"     The objective of this proposal is to collect pilot data to characterize the binding of     [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD).     Approximately two hundred thousand veterans will be returning stateside upon the end of     combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war     veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care.     Little is known about the dysregulation of PTSD veteran's neurochemical state including the     noradrenergic system which plays a primary role in memory and stress response. This includes     heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic     system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have     projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is     responsible for regulating and terminating noradrenergic transmission, and is a specific     marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET     protein. An unresolved problem in studying the noradrenergic system is identification of     suitable radiopharmaceutical to non-invasively measure alterations in the density of NET. The     investigators propose to address this challenge by using positron emission tomography (PET)     to measure stress-induced changes in NET expression in combat-exposed war veterans with PTSD.     The central hypothesis of this proposal is that war veterans with PTSD have an up-regulation     of NET in the locus coerulues resulting from hyperactivity of the noradrenergic system     compared to healthy controls. Through a series of experiments, the investigators will     determine the in vivo binding characteristics of [11C]MENET. The investigators will use this     information to optimally design an experimental protocol to measure the availability of NET     in a pilot group of combat-exposed war veterans with PTSD. The aims of this proposal are: 1)     Measure the uptake kinetics and whole brain distribution of [11C]MENET in combat-exposed     veterans with PTSD and healthy controls, 2) Develop a quantitative kinetic model of     [11C]MENET uptake to calculate the NET availability in brain. The subjects undergoing imaging     in this work will be recruited by Dr. J. Douglas Bremner (Co-Investigator) at Emory     University and Atlanta Veteran Affairs Hospital. Our long-term goal is to develop a     longitudinal study framework to assess the NETs dysregulation during onset of PTSD as well as     its transition to chronic lifetime PTSD.   "
113535|NCT01799824|"     The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary     axillary hyperhidrosis.   "
113536|NCT01799811|"     The objective Study is to evaluate the short- and long-term clinical outcomes of patients     receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open     bypass conduit to assess if there is a quantifiable correlation to time of placement as a     primary bypass graft and improved long-term clinical outcomes of patients with critical limb     ischemia (CLI).   "
113537|NCT01799798|"     Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children     5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta.     Efficacy will be assessed by DXA measurements at the lumbar spine of the areal bone mineral     density (BMD) which is the most frequently used parameter in trials investigating     osteoporosis.      The hypothesis of the study is:      Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast     maturation. Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL. BMD could     be increased during a 36 week treatment course with denosumab measured after 48 weeks.   "
113538|NCT01799785|"     Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an     impact or morbidity and mortality. Regular aerobic exercise training is a proven effective     therapy to improve exercise capacity in healthy and clinical populations. the effect of this     training has not yet been evaluated in cirrhosis. The safety of this intervention also     requires further study. Using a randomized controlled design, the investigators aim to     conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise     training on aerobic capacity.   "
113539|NCT01799772|"     Patients who undergo a replacement of their knees are generally older adults who have dealt     with severe knee pain and joint degeneration for a long time. The majority of them are     sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and     helps patients to live a better life. However, after the surgery, some patients have     difficulty performing basic activities such as walking, or going up-down stairs, and the     majority remains sedentary and gain weight. These combined problems leave patients at risk of     worsening their health. Therefore, a treatment that takes care of all these combined problems     is needed. We propose an all-inclusive treatment, called comprehensive behavioral     intervention (CBI) that intends to improve the long-term effects of exercise programs. The     CBI combines exercise program with promotion of physical activity, orientation on healthy     nutrition, and an education approach that promotes self-initiative towards healthy habits.     The overall aim of this proposed study is to test how patients post TKA will like the CBI     program, how safe the program is, and adapt the program as needed for better acceptability.     We believe the CBI will be safe, well tolerated, and will improve the ability of patients to     perform physical tasks. We also believe the program will increase the amount of physical     activity, will promote maintenance of healthy weight, and will help the patients to obtain     and maintain healthy habits. In this study subjects will be selected by a flip of a coin to     receive either our CBI program or a more traditional exercise program. Subjects will be     tested before and after the treatments. Our measures of main interest are how well subjects     move around and how physically active they are. We are also interested on the effect of the     interventions on body weight, blood pressure, eating habits, and general health. The team of     researchers for this study includes several disciplines. The proposed study will defend the     need for a larger study that can have a very important impact on the public health of     patients post TKA. The reason for the public health impact is if the physical limitations     experiences by patients post TKA are left untreated, they tend to get worse. Furthermore, by     increasing physical activity and promoting healthy weight, it may improve general health and     prevent chronic diseases. Last, developing educational intervention that promotes     self-initiative will result in long-term health benefits post TKA.   "
113540|NCT01799759|"     The proposed study is a continuation of a randomized, controlled pilot effectiveness trial     conducted in schools wherein the feasibility and completion of the trial by parents and     children will now additionally be examined in after school and YMCA connected programs.      The intervention for this study is Project FUN and Project FUN with Parents. Project FUN is     an 8 module online program for children in 4th through 8th grade. Project FUN with Parents is     a 6 module online program for their parent.      Children and parents will be recruited through the afterschool and YMCA connected programs.     Those agreeing to participate will be randomly assigned to a first intervention or second     intervention session (waiting list control group). Surveys and measures will be collected for     everyone pre-intervention, after the first session completion and after the second session     completion to create a waiting list control group.      Hypothesis 1: Body composition and dietary fat of children who complete Project FUN and have     a parent complete Project FUN with Parents will be lower on completion than children who only     complete instruments.      Hypothesis 2: Fruit and vegetable intake, physical activity and fitness of children who     complete Project FUN and have a parent complete Project FUN with Parents will be greater on     completion than children who only complete instruments.   "
113541|NCT01799746|"     In a controlled exposure setting, the study's goal is to determine the acute effect of diesel     exhaust (DE) inhalation on airway inflammation and hyperresponsiveness (AHR) in subjects with     mild to moderate stable asthma, using non-invasive measures.   "
113542|NCT01799733|"     The primary aim of this study is to examine the effects of co-administered wake therapy     followed by light treatment on mood, and secondarily on circadian rhythms, to test the     hypothesis that critically-timed chronotherapy improves mood by correcting phase disturbances     in melatonin and sleep in women with Premenstrual Dysphoric Disorder.   "
113566|NCT01799421|"     The purpose of this study is to identify prognostic factors and to develop predictive models     of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors     receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of     10-20%.   "
113544|NCT01799707|"     Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and     methods are needed to achieve vision restoration. Behavioral vision restoration training     (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise     such a method.      Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT     by daily one hour training for 3 months improves detection performance in perimetry compared     to a vision discrimination task in the intact visual field sector.   "
113545|NCT01799694|"     The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC     for the urinary incontinence after a radical prostate cancer surgery   "
113546|NCT01799681|"     To determine whether the 8-week Hopeful Outdoor Parkinson's Exercise (HOPE) Program would be     effective in improving balance performance, physical functions, gait parameter, balance     confidence, health-related quality-of-life, disease-specific motor performance and     fall-related outcomes in Parkinson's disease (PD) non-fallers and single fallers.   "
113547|NCT01799668|"     The research will examine psychotherapists' preferences for theoretical client     characteristics, such as age, gender, personality characteristics and symptoms. The research     will also examine the preferences' influence on the therapeutic alliance, from the     therapist's and the client's point of view.   "
113548|NCT01799655|"     Cardiovascular disease is the most common cause of mortality and morbidity worldwide.     Recently, a growing body of evidence has identified Vitamin D deficiency as a potential risk     factor for cardiovascular disease. Therefore, there is an increasing interest to explore the     mechanism in which vitamin D deficiency affect the cardiovascular system.      The investigators want to examine the relationship between serum vitamin D levels and the     coagulation status in the subjects. The applied the calibrated automated thrombogram (CAT) to     assess thrombin generation in plasma as a measure of overall thrombotic activity, and thus to     suggest a mechanism that may explain the link between vitamin D deficiency and cardiovascular     disease.      Our study population are going to include 100 patients from the internal departments in Emek     hospital, who present with chest pain but without acute coronary syndrome (ACS). The     investigators will take blood samples from the subjects to measure the serum vitamin D levels     and the generation of thrombin. The patients will be divided into four groups according to     the level of vitamin D to evaluate the effect of vitamin D levels in the blood on     coagulability and thrombotic activity in these patients.   "
113549|NCT01799642|"     Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly     reported symptom in patients with cystic fibrosis (CF). Due to the investigators' poor     understanding of how dyspnea develops, there are no treatments that consistently reduce     dyspnea in this population. The investigators aim to acquire a more comprehensive     understanding of the physiological mechanisms of exertional dyspnea in CF patients. This     study will likely identify an important physiological mechanism of dyspnea in CF and may     contribute to the development and use of effective treatments to reduce dyspnea in this     population.      The central hypothesis is that the impaired tidal volume (VT) response during exercise in CF,     in the setting of increased ventilatory demand will give rise to different qualitative     descriptions of exertional dyspnea compared with healthy age and sex-matched controls.     Specifically, CF patients will select increased work and effort as their dominant     descriptor of dyspnea up to the VT inflection/plateau. Beyond this point, CF patient's     dominant descriptor will become unsatisfied inspiration. In contrast, healthy control     participants will report increased work and effort throughout all phases of exercise and     will not report unsatisfied inspiration, even after the VT inflection/plateau.   "
113550|NCT01799629|"     To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the     elimination of meconium from the large intestine and thus reduce the incidence of feeding     intolerance in very low birth weight (VLBW) infants   "
113551|NCT01799616|"     The purpose of this study is to determine whether pamidronate is effective and well-tolerated     in the treatment of painful degenerative disk disease, also known as Modic type 1 changes   "
113552|NCT01799603|"     The purpose of this study is to investigate the effect of food on the pharmacokinetics     (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male     participants.   "
113553|NCT01799590|"     The purpose of this study is to evaluate the safety and efficacy of topiramate in     participants with migraine (type of severe headache that occurs periodically and is often     associated with nausea, vomiting and constipation or diarrhea) who completed the     JNS019-JPN-02 study.   "
113554|NCT01799577|"     This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking     Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic     tasks in an experimental model.   "
113555|NCT01799564|"     Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in     broad areas of the retina. The application of subthreshold micropulse laser spots in healthy     RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by     the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived     transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may     slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further     vision loss.   "
113567|NCT01799408|"     To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot     preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients     with osteoarthritis of the knee   "
113556|NCT01799551|"     Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is     recommended by the national bodies in many countries in the West. Our group has adapted CBT     for depression and psychosis in Pakistan for use with local clients. Initial evaluations have     found that these therapies are effective. However, due to the financial restraints it would     be useful if the investigators find that brief version of the CBT might be applicable and     effective in non western cultures. Therefore in this study, the investigators will be testing     effectiveness of brief version of culturally adapted CBT for depression in a randomized     controlled trial (RCT) in Pakistan.   "
113569|NCT01799382|"     The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can     increase the percentage of patients with advanced non-squamous non-small cell lung cancer in     whom both pathologic subtyping and mutational analysis are obtained.   "
113557|NCT01799538|"     Background:      - Lymphangioleiomyomatosis (LAM) is a rare type of lung disease that occurs almost     exclusively in women. In LAM, muscle tissue grows in the lungs and starts to block the flow     of air. It is a progressive disease, and in severe cases may require a lung transplant. One     possible treatment to improve breathing in people with LAM is inhaled albuterol. Albuterol     can be given in a metered dose inhaler (MDI) or with a nebulizer. Researchers want to compare     these methods to see which method best improves lung function in women with LAM.      Objectives:      - To see whether a nebulizer or MDI can better improve lung function in women with LAM.      Eligibility:      - Women at least 18 years of age who have impaired lung function because of LAM.      Design:        -  Participants will be screened with a physical exam and medical history. No lab tests          will be needed for this study.        -  Participants will have a 3-day overnight stay at the National Institutes of Health.          Those who are using long-acting inhalers will have to stop taking these drugs 1 week          before the study.        -  Participants will receive either the nebulizer or two or four puffs of the inhaler. Four          puffs of albuterol is a higher dose than is normally prescribed, and is being tested on          this study.        -  Participants will have each treatment around the same time of day on each of the 3 days.          Before and after taking the albuterol, participants will have lung function tests.   "
113558|NCT01799525|"     Delayed cerebral vasospasm and secondary ischemic infarction are feared complications after     aneurysmal subarachnoid hemorrhage (aSAH). To date, there is no effective therapy to prevent     these ischemic complications. The arterial partial pressure of carbon dioxide (PaCO2) is one     of the main determinants of cerebral blood flow (CBF) in healthy subjects. It is yet largely     unknown, if and to what extent modulations of PaCO2 can influence CBF in patients after aSAH.     The trial is a phase 1 study in which the feasibility of hypercapnia in SAH patients is     tested. PaCO2 is gradually raised to 60 mmHg in 10 mechanically ventilated aSAH patients.     Cerebral oxygen saturation measured by NIRS and CBF determined by an intracerebral     thermodilution probe are the primary end points. If the feasibility is confirmed, this trial     will be followed by a phase 2 dose finding study.   "
113559|NCT01799512|"     Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit     (MICU) and is associated with increased morbidity and mortality. However, randomized     controlled trials examining the effects of strict glycemic control demonstrated conflicting     results. A common finding in these trials was the high risk of hypoglycaemia.      This randomized controlled trial evaluates the impact of real-time continuous glucose     monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU     patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.   "
113560|NCT01799499|"     This study is a prospective randomized open labeled dose ranging comparative study. Twenty     four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for     the study following the initial diagnostic cystoscopy.      The investigators believe that this study is of importance on several aspects:        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the          current instillation mode.        2. If proved effective, this mode of treatment might save the need for TURBT performance          and serve as a new mode of tumor ablation.        3. Even if proved partially effective, this mode of treatment will diminish tumors size          and/or number, thus enable a more limited TURBT procedure.        4. This mode of treatment will enable immediate medical attendance to the patient's tumor          recurrence without the waiting period (resulting from queues in the medical centers) for          TURBT. This might improve the patient's prognostic outcome.        5. If this experimental treatment will prove to have a better ablative effect in comparison          to the standard of care known in the art, this could be translated to a better          prophylactic effect of tumor recurrence.        6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor recurrence          prevention will enable us to reduce adverse effects of higher drug dosage.   "
113561|NCT01799486|"     Chronic hepatitis B virus (HBV) infection is a serious clinical problem because of its     worldwide distribution and potential adverse outcome, including cirrhosis, which is a major     cause of HBV related death. Studies show the use of nucleot(s)ide analogs treatment can     alleviate, even reverse the progress of HBV-related cirrhosis. In cirrhosis stage, some     potential factors, including endocrine disorder, renin, aldosterone, vasopressin increasing,     hepatitis B virus related nephritis, hepatorenal syndrome, may cause renal damage. With the     exposure of NAs, adverse reports of rhabdomyolysis, renal dysfunction, and lactic acidosis     are increasing. So when choosing NAs, the potential renal function impairment should be     considered.      Recently, Gane, Xiaoxi Li have separately reported that Telbivudine can improve estimate of     glomerular filtration rate (eGFR) of patients with chronic hepatitis B, while eGFR of     patients with Lamivudine, adefovir and entecavir have a trend of decrease, which suggested     Telbivudine may have renal protective effects. This effect on patients with HBV-related liver     cirrhosis has not been studied, which is not clear now.      This study is a randomized controlled study to prospectively observe Telbivudine's effect on     renal function, which aims to provide evidence in antiviral treatment for the patients with     cirrhosis.   "
113562|NCT01799473|"     This prospective, observational, multi-center, patient registry will follow patients who are     newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once     enrolled, the patients' dose and titration will be followed for the first 6 months of     treatment with Tyvaso.      A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24     to review their dose and titration schedule. In addition to patient-reported dosing data,     some patient demographic information, will be collected by the investigative site at     Baseline.   "
122466|NCT01683084|"     The purpose of this study is to determine if telmisartan is effective in slowing the     progression of abdominal aortic aneurysms and reducing circulating concentrations of     Abdominal Aortic Aneurysms (AAA) biomarkers.   "
113568|NCT01799395|"     Lung cancer may cause central airway obstruction through several different mechanisms     (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).      The aim of the present study is to determine the prevalence at the time of diagnosis, the     incidence at 1 year from the diagnosis, and the predictors of central airway obstruction     associated with advanced lung cancer.   "
120289|NCT01711424|"     This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine     clinical setting. Treatment decisions are made by the physician and reflect the physician's     current standard of care.   "
113570|NCT01799369|"     Background Surgeons lack a routine, objective evaluation of patient condition after surgery.     We currently rely on subjective assessment of available patient data. The current scoring     methods such as Acute Physiology and Chronic Health Evaluation and Physiological and     Operative Severity Score for the enUmeration of Mortality and morbidity are complex and     cumbersome and have therefore not been adopted into routine practice.      The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3     parameters collected during the operation: lowest heart rate, lowest blood pressure,     estimated blood loss (Regenbogen et al., Arch Surg 2009).      Previous validation studies have shown a good correlation between the score and incidence of     major complications or death occurring within 30 days. For example, 75% patients with a score     of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10. To     date, the SAS has never been clinically applied and tested in a trial.      We believe that routine use of the SAS will lead to a reduction in major complications and     deaths after surgery. We also believe that it will lead to a reduction in the severity of the     complications.      This is based on our theory that the SAS eliminates the guesswork. Using this score will add     objectivity and clarity to clinical decisions that are presently based on clinical instinct     or 'gut feeling'. The score will more clearly highlight those patients who are at an     increased risk of developing complications or dying and will flag them up for increased     monitoring, a higher index of clinical suspicion and a lower threshold for early management     of problems.      Primary Aim The primary aim of the pilot is to strengthen the design and assess the     feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200     in total. The primary aim of the main study will be to establish if clinical application of     the SAS leads to a reduction in 30-day post-operative morbidity and mortality.      Study Design The design of this pilot is the same as what the main trial will eventually be:     a multicentre single-blind randomised controlled trial (RCT). Current data suggests the     overall expected major complication or death rate in our target population would be 21%. The     sample size of the future RCT is therefore estimated to be 986 each group to detect a 5%     reduction in complications (Significance 0.05%, Power 80%).      Outcomes Our primary outcome will be major complications or death within 30 days of     operation. Our secondary outcomes (all within 30 days of operation) will be minor     complications, primary and secondary critical care admissions and length of stay, duration of     therapeutic antibiotics, number of additional operations under general anaesthetic to treat     complications, and overall length of stay.   "
113571|NCT01799356|"     We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg     twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin     monotherapy, 400 mg once daily, for 14 days   "
113572|NCT01799343|"     Pregnant women with pre-eclampsia and growth restricted fetuses often have a reduced function     of the placenta. This is accompanied by an increased perinatal mortality and morbidity.      By ultrasound it is possible to measure blood flow and vascular resistance in both the fetal     umbilical cord and in the blood vessels supplying the uterus. A high resistance in these     vessels occur before the child is severely affected.      By immersion in water extracellular fluid is redistributed back into the circulation, and     central blood volume increases. Previous studies have shown that maternal minute-volume     increases, while blood pressure drops slightly. Also an increased amniotic fluid has been     recorded. This has been interpreted as an expression of increased renal blood flow. Immersion     into water could increase blood flow in the vessels supplying the uterus and thus increase     blood flow to the child.      The investigators aim to clarify this by examining blood flow and resistance in the blood     vessel supplying the uterus and in the umbilical cord, while the participant is immersed into     water. Initially, 25 healthy women with an uncomplicated singleton pregnancy recruited from     the Department of Obstetrics and Gynaecology: Hvidovre University Hospital, Denmark, will be     examined. The participant will act as its own control and measurements above water and     immersed will be conducted at the same study session.      Ultimately the investigators seek to contribute to a non-invasive option for prolonging those     pregnancies where the fetus and/or maternal condition requires delivery several weeks before     term, and where immersion of the pregnant woman in the water a few hours one to several times     daily, may prolong the pregnancy the required number of hours/days for antenatal steroid     treatment to be sufficient.      There are no risks associated with the study and the project team considers it ethical to     implement this. The study is not supported by pharmaceutical companies or other groups with     economic interests. The project group itself has taken the initiative to study.   "
113573|NCT01799330|"     The two hypotheses to be tested in this study are that:        1. The administration of transcutaneous electrical muscle stimulation (TCEMS) after          completion of conventional exercise training in pulmonary rehabilitation (PR) will          result in further improvements in exercise tolerance, functional status and symptoms of          patients with stable chronic obstructive pulmonary disease (COPD) above those achieved          in PR alone.        2. TCEMS can improve exercise tolerance, functional status and symptoms even among COPD          patients who fail to make gains in exercise tolerance by participating in conventional          PR due to their debilitation and/or marked cardio-respiratory impairment.   "
113574|NCT01799317|"     The study outlined is designed to measure and to determine whether the combined use of     vitamin D2 (ergocalciferoI) and 1-alpha-hydroxyvitamin D2 (doxercalciferol)) or     doxercalciferol alone will correct the mineralization defect in pediatric patients with     established secondary hyperparathyroidism (2°HPT) undergoing regular peritoneal dialysis.     Serum phosphorus levels will be controlled with a calcium¬-free-metal free phosphate binder;     (obtained at baseline and after 8 months of treatment) sevelamer. Indices of bone     mineralization obtained at baseline and after 8 months of treatment will be measured by     quantitative histomorphometry in iliac crest bone biopsies after double tetracycline     labeling. Immunohistochemistry will be done in specimens of bone biopsies from iliac crest to     examine the expression for selected markers of bone turnover and mineralization such as     FGF-23, DMP1, MEPE and OPG. Serum PTH levels will be measured with the 1st and 2nd generation     immunometric assay (PTH-IMAs) and fibroblast growth factor-23 (FGF-23) will be determined by     one assay with specific detection antibodies that are against epitopes within the C-terminus     of FGF-23 and another assay that uses antibodies against epitopes within the N- and     C-terminal portions of the molecule respectively. The value of non-invasive assessment of     bone mass by quantitative computed tomography (QCT) and its relationship with vascular     disease determined by ultrasound (US) of intimal carotid thickness (CIMT) will be correlated     with bone histomorphometry and the different biochemical determinations.   "
113612|NCT01798823|"     The goal of the project is to define the prevalence and inflammatory background of     exercise-induced bronchoconstriction (EIB) in school children and determine individual and     environmental risk factors for EIB. The obtained results will provide objective measures on     biological processes leading to bronchoconstriction during exercise, as might be experienced     naturally during the school life. The results could be applied in the management of EIB     patients with or without asthma. The results of planned research will be published in     journals with national and international impact, and presented during symposia and     conferences.   "
123269|NCT01672489|"     The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers     using objective measures of drowsiness and driving performance in an instrumented research     vehicle.   "
113633|NCT01798524|"     Kidney transplantation is the renal replacement therapy of choice for the majority of     patients with end-stage kidney disease. Epidemiological studies of kidney allograft     recipients can aid in the understanding of cause and effect of health and disease     post-transplantation. The combination of health care and information technology has made the     potential of transplant professionals to use health information effectively crucial to guide     kidney transplant management. The aim of this study is to undertake an observational cohort     study of kidney allograft recipients, supported by linking analysis across different database     sources, to provide a comprehensive biomedical dataset of information.   "
113575|NCT01799304|"     Cerebral palsy (CP) concerns 2 children out of 1000 in the general population (SCPE 2002). It     is the main cause of postural and motor deficits in children.      During the past 20 years, the postural deficits exhibited by these children have been     attributed to various factors :        1. neuromuscular functions        2. sensory integration        3. muscular-squeletic functions.      The common point of all these studies is the existence of immature motor patterns, probably     related to an inability to implement more elaborated and adapted motor patterns with respect     the task to perform.      CP children do not develop the characteristics of the plant grad locomotion. They exhibit a     uniform muscular activation with a high level of co-activation. Locomotion is generally     characterized by an increase of stretching reflexes at short latencies and by a low level of     activation associated to a low modulation of gastrocnemius muscles..      These data also suggest that it is the control of the temporal rather than the spatial     parameters of the head which are mainly altered in CP children.      Even though static postural control and locomotion are considered as automatic processes,     this control requires, however, a significant amount of attentional resources.      Within this context, the amount of attentional resources which need to be solicited can     provide information on two complementary dimensions. On one hand, on the level of     automaticity of postural control and/or locomotion when subjects' attention is oriented     toward another task. On the other hand, on the cognitive cost of postural control and/or     locomotion, depending on children age, that is, as a function of their level of maturation     and of the nature and importance of their sensory-motor deficits. When the amount of required     attentional resources is reduced, postural control and/or locomotion is considered as     automatic processes with a low cognitive cost.      The dual task paradigm in which subjects have to simultaneously process a cognitive (e.g.     Stroop task) and a postural or motor task (e.g., standing upright on a force platform) is     generally used to investigate these questions.      How an appropriate allocation of attention is performed as a function of the cognitive and     postural/motor tasks is important in the developmental process of posture and locomotion. It     seems to be even more crucial in CP children and more generally in pathology.      The main goal of the present project is to investigate the contribution of attentional     processes in postural control and locomotion of CP children as compared to control healthy     children.   "
113576|NCT01799291|"     The primary aim is to test the efficacy of a new intervention to improve clinical judgment.     The investigators focus on the assessment of pediatric bipolar disorder (PBD), a     controversial diagnosis with frequent diagnostic errors, by educating mental health     professionals in common cognitive pitfalls and training them in recommended de-biasing     strategies. The investigators hypothesize that the Treatment group will show higher     diagnostic accuracy than the Control condition: Participants receiving the cognitive     de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity     bias. Secondary aims include soliciting feedback about whether the skills were useful when     diagnosing the vignettes, and whether skills and cases seem clinically realistic.   "
113577|NCT01799278|"     This study will evaluate the response rate of MLN8237 in patients with histologically     confirmed or clinically suspected metastatic neuroendocrine prostate cancer (NEPC). MLN8237     is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor     activity in vitro and in vivo. In preclinical models, aurora kinase inhibition resulted in     dramatic and preferential anti-tumor activity in NEPC with suppression of neuroendocrine     marker expression.   "
113578|NCT01799265|"     The purpose of this study is to determine whether the Transcend Auto is as effective in     treating obstructive sleep apnea as another device that is already on the market.   "
113579|NCT01799252|"     The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The     experiences of women prescribed routine antibiotics after medical abortion is missing from     the existing evidence. This study seeks to add to the literature evidence of the side effects     associated with antibiotic treatment that women experience and their adherence to prescribed     regimens.   "
113580|NCT01799239|"     The aim of the current investigation is to evaluate the combination of an adhesive with a     soft top film.   "
113581|NCT01799226|"     This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental     gingivitis model developed by Löe et al. Half of the participants will use Colgate Total®     (which contains triclosan), while the other half will use a toothpaste which does not contain     triclosan as the control.   "
113582|NCT01799213|"     Knee osteoarthritis (OA) is now recognized as a major health problem. It is the number one     cause of lower extremity disability and has significant deleterious effects on quality of     life. While there are numerous therapies available for knee OA, most have limited efficacy.     Of particular concern, is the widespread use of nonsteroidal anti-inflammatory drugs (NSAIDs)     for this disorder. Veterans, as a group, are at high risk for both gastrointestinal and     cardiovascular NSAID-induced complications. In this study the investigators propose to     examine whether replacing NSAIDs with cognitive behavioral therapy delivered by telephone is     an effective strategy for Veterans with knee OA. Telephone-administered therapy is     particularly appealing since Veterans with knee OA are more likely to have limited mobility.     If successful, this program may result in significant cost-savings for both Veterans     (decreased co-pays and transportation costs) and the VA (decreased hospitalizations due to     NSAID induced toxicity).   "
113583|NCT01799200|"     The primary objective of this study is to investigate factors hypothesized to influence the     prevalence of hip pathomorphology (femoroacetabular impingement, dysplasia) in young adults.     To complete this objective, we will quantify the prevalence of radiographic measures     indicative of hip pathomorphology in collegiate athletes and age-matched controls. This data     will allow us to test our main hypothesis, that the prevalence of hip pathomorphology is     higher in collegiate athletes than age-matched controls. To further elucidate the factors     which may increase the prevalence of hip pathomorphology, we will correlate the radiographic     measures to sport involvement history, hip function and demographics, as collected by means     of a questionnaire.      The secondary objective of this study is to determine if physical exams (range of motion,     impingement test) could be used to screen for radiographic measures of hip pathomorphology in     athletes and age-matched controls. To complete this objective, we will correlate range     physical exam results to the radiographic measures and determine each exam's sensitivity and     specificity to detect abnormal morphology.   "
113584|NCT01799187|"     Revascularization is an alternative new treatment of immature permanent teeth with necrotic     pulp nowadays while apexification is the traditional therapy. The investigators suppose that     revascularization is superior to apexification at developing the root of immature permanent     teeth and reducing the risk of root fracture,and the research is designed.   "
113613|NCT01798810|"     The OXYGEN Study is a double blinded prospective randomized controlled trial that will     compare the proportion of surgical site infections within 6 months in patients treated with     Supplemental Perioperative Oxygen compared to those treated without Supplemental     Perioperative Oxygen.   "
113614|NCT01798797|"     A prospective post-market study to evaluate the performance and clinic usability of heart     failure risk status (HFRS) feature on CareLink.   "
113649|NCT01798316|"     The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain     management after laparoscopic cholecystectomy to determine if its use to supplement standard     of care pain management decreases the incidence of post-operative nausea and vomiting.   "
113585|NCT01799174|"     This is a randomized, blinded, and controlled trial to assess the efficacy and safety of UVA1     phototherapy in the treatment of active morphea in adults and children. Forty patients will     be randomized to receive either medium dose (70 J/cm2) phototherapy (active UVA1     phototherapy) with an ultraviolet translucent acrylic screen or sham UVA1 (0 J/cm2)     phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The     phototherapists, patients, and principal investigator will be blinded to whether the patients     receive active or sham UVA1 phototherapy. Patients will only be allowed to apply emollients     during the study.      Patients completing the randomized placebo controlled trial (RPCT) will be followed during an     open observation period for 3 months. During the open phase, all outcome measures from the     RPCT (LoSSI, PGA-A) will be assessed every 5 weeks as well as adverse events. Patients who     received sham UVA1 phototherapy will be invited to receive active UVA1 phototherapy using the     same protocol as in the RPCT during the open observation. Adult patients enrolled in the RPCT     will also be part of a nested translational study investigating the effect of UVA1     phototherapy on gene expression from whole skin biopsies taken before (Study Visit 1) and     after UVA1 phototherapy (Study Visit 3). Gene expression profiles will be compared in     lesional skin before and after treatment as well as nonlesional skin.   "
113586|NCT01799161|"     NSCLC tumors are appropriate targets for active immunotherapy, because they are     non-immunogenic, which indicates that NSCLC does not stimulate a spontaneous immune response.      NSCLC tumor-secreted gp96-Ig is an ideal vaccine because it combines adjuvant activity with     polyvalent peptide specificity. Tumor secreted gp96 activates dendritic cells (DC), natural     killer cells (NK) and cytotoxic T lymphocytes (CTL). Tumor cells can be killed by NK-specific     mechanisms, by promiscuous killing of CD8 CTL through NKG2D, and by MHC restricted CD8 CTL     activity. The activation of DC and NK by tumor secreted gp96 may also counteract the     generation of immuno-suppressive CD4 regulatory cells.      Suppression of adenosinergic pathways by oxygen and theophylline in combination with     immunotherapy will improve tumor rejection.      Allogeneic, gp96-Ig secreting tumor cells used as vaccine are expected to generate NK and CTL     with activity to the patient's autologous tumor.   "
113587|NCT01799148|"     The objectives of this study are: 1) To determine whether patients with acute coronary     syndrome, the level of environmental exposure to particulate air pollutants in the week prior     to admission, are related to concentrations of inflammatory molecules and oxidative stress.     2) To investigate whether the level of environmental exposure is an independent prognostic     factor in terms of overall and cardiovascular mortality, myocardial infarction or unstable     angina at 30 days, 6 and 12 months.   "
113588|NCT01799135|"     This is a pilot study. A pilot study is done with a small number of participants to see if a     technique works before using it in a larger research study. This pilot study is evaluating a     special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI).      DCE-MRI can demonstrate how much blood flows through the tumor and lungs and tell us how     active the tumor is, as well as how functional the lungs are. As part of this scan,     participants will receive an intravenous (into the blood via puncture of a vein) injection of     gadolinium contrast, a dye that helps us see the tumor and lung tissue more clearly.     Gadolinium is approved by the FDA and is routinely used for MRI.      The goal of the study is to determine whether DCE-MRI can provide images of the response of     the tumor and the normal lung tissue to SBRT and to potentially hep improve     treatment-planning methods for patients treated with SBRT in the future. We will also study     how the final DCE-MRI scan compares with another form of imaging, called 4-dimensional     computed tomography (4D-CT), that looks at the breathing capacity of the lungs. Although we     are researching the usefulness of DCE-MRI in early stage non-small cell lung cancer treated     with SBRT in this study, DCE-MRI with the dye injection is not an experimental technology and     is routinely used in the clinic for other indications. The 4D-CT scan is also not     experimental and is used for radiation planning and imaging of the lungs.      The SBRT you will receive will be standard treatment and will not be affected by your     participation in this study or by these DCE-MRI scans. That means that the findings on the     scan will not be used to alter your planned treatment in any way. Additionally, participants     will undergo the routine work-up prior to SBRT and surveillance studies after treatment is     complete.   "
113589|NCT01799122|"     Randomized comparison of two surgeries for the treatment of female stress urinary     incontinence.   "
113590|NCT01799109|"     Asthma is a common chronic respiratory illness which results in frequent wheezing,     cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy,     β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although     inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma     exacerbation, there are still some asthmatic children unresponsive to this management. The     Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate     (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous     MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g     relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB     provides greater benefit in severe asthma exacerbation.   "
113591|NCT01799096|"     This study partially replicates two previous studies with normal weight women, and overweight     women. Both found that women could compensate for sucrose added to the diet in carbonated     soft drinks (4 x250ml total1800 kJ per day) when it was given blind over a period of 4 weeks.     The hypothesis is that this applies also to obese women, who will not gain weight, increase     overall energy intake in the diet, or eat differently whilst consuming sucrose. 42     participants shall be randomly assigned to either be given carbonated drinks that contain     sucrose, or drinks that are artificially sweetened.   "
113592|NCT01799083|"     Determine alone or in combination with chemotherapy or autologous cytokine induced killer     cells are effective and safe in the treatment of patients with relapsed and/or refractory     solid tumors or B Cell lymphomas.   "
113615|NCT01798784|"     In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients     with suboptimal cholesterol control who are at high risk for CVD, the study investigators     propose to test the effectiveness of different behavioral economic techniques in inducing     habit formation for adherence to statin use and sustained reductions in LDL cholesterol after     financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to     12 months (6 months after cessation of financial incentives).   "
113593|NCT01799070|"     Background: Cerebral hyperperfusion syndrome (CHS) is a life threatening complication of     carotid endarterectomy (CEA) and the changes of middle cerebral artery velocity are used to     predict the occurrence of CHS but the accuracy is limited. In addition, changes of BP     post-operatively comparing with baseline BP should be a predictive factor of CHS.      Objective: The investigators aimed to create a predictive index, velocity systolic blood     pressure index (VSI), for improving the predictive power of Transcranial Doppler monitoring     regarding CHS.      Methods: The study design is a diagnostic test, which is an observational analytic clinical     study. From March 2013 to September 2014, 200 patients will be recruited. Patients will be     classified according to the CHS occurrence. VSI combined the changes of middle cerebral     artery velocity and blood pressure crossing CEA and the intra- and post-operative increase     ratios of middle cerebral artery velocity were calculated. Their prediction power of CHS will     be compared. Sensitivity, specificity, positive predictive value, negative predictive value     of them will be calculated. Receiver operating characteristic analysis will be performed.      Expected Outcomes: Comparing with the commonly used intra-operative and post-operative TCD     monitoring, VSI may be more useful to select CHS in patients who underwent CEA. As far as the     investigators know, analysis or studies combining the BP and velocity changes in the     prediction of CHS have never been performed.   "
113594|NCT01799057|"     The purpose of this study is to determine the effects of metformin on functional capacity     (pain-free and maximum walking times) in individuals with peripheral artery disease     (PAD)-related intermittent claudication.   "
113595|NCT01799044|"     Irreversible electroporation is a new, minimal-invasive image-guided treatment to treat     tumors near or around vulnerable structures, such as central liver tumors.      To investigate the safety and efficacy of IRE in the treatment of colorectal liver     metastases, patients with resectable colorectal liver metastases undergo IRE and resection of     the metastases in the same session. After resection, the specimen is examined macroscopically     to determine vitality using a specific vitality staining (triphenyl-tetrazoliumchloride) and     to visualize the exact ablation zone. Subsequently, histopathologic examination is used to     determine type of cell death and the microscopic ablation zone.      The investigators hypothesize that IRE is a safe effective method to treat colorectal liver     metastasis and that cell damage and cell death is demonstrated as soon as 1 hour after the     procedure.   "
113596|NCT01799031|"     This randomized clinical trial studies an educational intervention for reducing work     disability in breast cancer survivors. Web sites providing symptom management education may     be an effective method to help breast cancer survivors reduce work disability after treatment   "
113597|NCT01799018|"     The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral     Vasospasm following Subarachnoid Hemorrhage   "
113598|NCT01799005|"     Atherosclerosis progressively occurs with increasing age in the general population. So far     most dietary intervention studies with flavanols were performed over short time frames and in     small groups of young healthy and older patients with manifest cardiovascular disease,     respectively. Vascular health is defined as absence of vascular disease and the presence of     optimal parameters that determine the development and progression of arteriosclerosis     (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether     flavanols can improve parameters of vascular health, most importantly endothelial function,     when given repetitively to healthy middle aged and which factors affect the efficacy of     flavanol interventions.   "
113599|NCT01798992|"     The primary goal of the study is to measure in the intact human heart, the alterations in     gene expression over time that are associated with reverse remodeling in response to     β-blockade. The second goal is to investigate the signaling mechanisms which in turn are     responsible for these changes in gene expression, and the third goal is to determine the     relationship between intrinsic systolic dysfunction and remodeling of the left ventricle.     This will be accomplished by measuring ventricular size, function, and gene expression in     myocardial tissue samples obtained by percutaneous biopsy prior to initiation of β-blockade     and at 3 and 12 months after start of therapy. The specific Aims and Hypotheses to be tested     are:        1. Aim: Determine the changes in gene expression associated with changes in intrinsic          systolic function and with functional decompensation in the intact, failing human heart.           a. Hypothesis: Changes in the expression of select genes precede or accompany changes in          left ventricular systolic function in humans with idiopathic dilated cardiomyopathy          (IDC).        2. Aim: Identify signaling mechanisms responsible for alterations in expression of key          genes involved in mediation of ventricular hypertrophy or contractile dysfunction.           a. Hypothesis: Myocardial-failure-associated regulation of select messenger ribonucleic          acids and proteins are related to left ventricular wall stress and neurohormonal          signaling.        3. Aim: In the relationship between contractile dysfunction and dilatation/remodeling,          determine the relationship between contractile dysfunction and structural remodeling.           b. Hypothesis: the contractile dysfunction is primary and structural remodeling          secondary.   "
113600|NCT01798979|"     This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of     GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted     normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2     occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of     GLPG0634 (daily for 7 days).      Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with     midazolam in healthy male subjects will be evaluated.   "
113616|NCT01798771|"     The investigators hypothesize that the rate of radiologically complete resections of     contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced     fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to     surgeries aided by 5-ALA induced fluorescene alone.   "
113617|NCT01798745|"     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the     drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in     participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety     and tolerability of JNJ-54452840 will also be assessed.   "
113619|NCT01798719|"     Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated with     the metabolic syndrome. As the disease stems from excess calorie intake and lack of physical     activity, the correction of unhealthy lifestyles is the background of any prevention and     treatment strategy   "
113601|NCT01798966|"     Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher     orbital fat contents due to their disease process. The confined space of the orbit cannot     hold the enlarged orbital contents creating a forward displacement and/or compression of the     globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical     decompression, a procedure that fractures orbital bones, in order to allow more space for the     enlarged orbital contents to occupy. To date, there is no data that shows intraocular     patterns over a 24-hour period in patients with mechanical compression on the globe as in     TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns,     glaucomatous patterns, or perhaps completely different then either. The goal of this project     is to investigate patterns of IOP in patients requiring orbital decompression because of     orbital congestion. Changes in IOP during a 24-hour period will be studied with a     contact-lens embedded sensor that provides continuous data. This device has previously been     investigated and shown to be safe and well-tolerated. Monitoring the pattern in these     patients will allow us to compare Thyroid TED patterns of IOP with those of normal and     glaucomatous patients. Also, testing these patients before and after orbital decompression     surgery will allow characterization of how intraocular pressure changes once the mechanical     compression on the globe is relieved.   "
113602|NCT01798953|"     Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative     colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this     study was to determine the functional outcome after surgery, frequency of pouchitis,     complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both     ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.   "
113603|NCT01798940|"     Objective:      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride     Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing     periods of studies were separated by a washout period of 12 days and 11 days respectively.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, and Open-Label   "
113604|NCT01798927|"     The purpose of this study is to investigate the impact of a specifically designed ankle foot     orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and     temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals     living with Parkinson's disease.   "
113605|NCT01798914|"     The purpose of this study is to allow patients with specific needs for inhaled insulin to     continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn     from the market.   "
113606|NCT01798901|"     This phase I trial studies the side effects and best dose of AR-42 when given together with     decitabine in treating patients with acute myeloid leukemia. AR-42 may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving AR-42 together with     decitabine may kill more cancer cells.   "
113607|NCT01798888|"     Background:      - Current treatments for alcoholism have limited success. More than half of people with     alcoholism return to uncontrolled drinking even after treatment or self-help programs. One     possible treatment is the use of deep brain stimulation (DBS). DBS studies of the ventral     capsule/ventral striatum, a region of the brain, reduced cravings for alcohol in a small     group of alcoholics. DBS is approved for treating other disorders, such as Parkinson s     disease, but not for treating alcoholism. Researchers want to study whether DBS can be used     to treat chronic alcoholism.      Objectives:      - To see if deep brain stimulation is helpful and safe for people who have chronic     alcoholism.      Eligibility:        -  Individuals between 21 and 60 years of age who have been diagnosed with chronic          alcoholism.        -  Participants must have tried for more than 10 years to stop drinking alcohol, and have          failed multiple treatment and self-help programs. They may not have any other current          substance abuse or dependence problem (except alcohol and nicotine).      Design:        -  Participants will start the study by entering a separate alcohol detoxification study at          the National Institutes of Health. They will be monitored during this study with blood          tests and brain scans.        -  Participants will have 2 weeks of baseline tests. They will include physical exams and          blood and urine tests. They will also include tests of thinking and memory, and          questions about current moods.        -  Participants will have surgery to insert the DBS device. Electrodes will be placed in          the brain and a battery pack will be placed in the chest. Participants will recover from          the surgery and continue the alcohol detoxification program.        -  About 4 weeks after surgery, participants will be separated into two groups. For one          group, the DBS device will be turned on with electrical stimulation and participants          will be monitored for an additional two weeks in the hospital to find the right setting          for the device. For the second group, participants will receive mock stimulation, but no          real electrical DBS, and will also be monitored for an additional two weeks in the          hospital.        -  Participants will return home for 24 weeks. During this time they will have frequent          study visits to look at the DBS device. These visits will include questions about mood          and memory, as well as imaging studies.        -  All participants will return for an additional two week inpatient stay in the hospital.          Those participant who had initially received mock stimulation will now have their          devices turned on with real electrical stimulation and will be monitored for the two          weeks to find the right setting for the device. Those participants who had initially          received real stimulation will continue to receive stimulation while being monitored for          the two weeks.        -  Participants will return home for another 24. All participants at this point will have          actual electrical DBS. Participants will continue to have frequent study visits for up          to a year to look at the DBS device. These visits will also include questions about mood          levels and alcohol cravings.   "
113608|NCT01798875|"     In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS) is     also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead     to the development of diabetes, hypertension, atherosclerosis and coronary heart disease.     Serum markers of inflammation are being increasingly recognized as predictors of     atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently     proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes     mellitus. Therefore, the aim of the present study is to evaluate the effects of commonly used     non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives,     metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular     risk markers in women with PCOS. The study hypothesis is that some of the commonly used     therapies of women with PCOS may have more favorable effects on classical and surrogate     markers of cardiovascular risk then others or some of them may even confer a higher risk of     cardiovascular events   "
113609|NCT01798862|"     The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle     sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients     with previous IVF failures.   "
113610|NCT01798849|"     This study will evaluate safety, tolerability and effects on central diastolic blood pressure     (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and     in male participants with mild-to-moderate hypertension (Panel C).   "
113611|NCT01798836|"     To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH     agonist /GnRH antagonist protocol   "
113618|NCT01798732|"     The main objective of this study is to characterize the changes in IOP over 24 hours after     selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type     of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in     ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve     head after selective laser trabeculoplasty.   "
113620|NCT01798706|"     Primary objective:      - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic     control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes     participants (T2DM) who are inadequately controlled with their current anti-diabetic     treatment regimen.      Main secondary objective:      - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM     participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic     hypoglycemia and gastrointestinal side effects).      Other secondary objectives:        -  To assess the effect of lixisenatide compared to placebo after 24-week treatment on:             -  Fasting plasma glucose (FPG);             -  During liquid standardized breakfast meal challenge test : 2 hour- Postprandial               Plasma Glucose (PPG) and Plasma Glucose Excursion;             -  7-point Self-monitored plasma glucose (SMPG) profile;             -  Body weight;             -  Change in total daily dose of basal insulin (if taken);             -  Percentage of participants requiring rescue therapy             -  Safety and tolerability;        -  To assess lixisenatide pharmacokinetic profile;        -  To assess anti-lixisenatide antibody development.   "
113621|NCT01798693|"     Rotator Injury:        -  Strength/range of Motion        -  ASES, VAS   "
113622|NCT01798680|"     The purpose of this study is to determine the efficacy and safety of vitamin D3     (cholecalciferol) supplementation on HIV progression and incidence of pulmonary tuberculosis     among HIV-positive Tanzanian adult men and women initiating highly active antiretroviral     therapy (HAART).   "
113623|NCT01798667|"     This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the     optimal dose of DA-8031 in male patients with premature ejaculation after oral administration     on-demand.      The investigators hypothesized that newly-developed DA-8031 would effect in delaying     ejaculation in patients with premature ejaculation (PE).      Design:      Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design   "
113624|NCT01798654|"     The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle     aspiration (EUS-FNA) for patients with antithrombotic agents.   "
113625|NCT01798641|"     The goal of our study is to verify the effectiveness of the shunt and to identify the most     sensitive criteria to select patients for surgery. The study is designed to assess     improvement in walking and balance (gait), urinary function and memory after shunting. In     addition, the study aims to identify the most accurate and sensitive tools to measure     improvement for our patients.   "
113626|NCT01798628|"     The purpose of this study is to determine the effect of food on the pharmacokinetics (how the     drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a     single dose in healthy male volunteers.   "
113627|NCT01798602|"     The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with     suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and     study procedures.   "
113628|NCT01798589|"     The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when     prepared using methylcellulose versus preparation using polyvinylpyrrolidone.   "
113629|NCT01798576|"     This prospective, national, multicenter, observational study will evaluate in routine     clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon     alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with     chronic hepatitis C who failed previous treatment. Participants will be followed for the     duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.   "
113630|NCT01798563|"     In this study the investigators are looking at two subtypes of Parkinson Disease (PD);     tremor-dominant (TD) and postural imbalance and gait disorder (PIGD). This study will use     magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a     finger-tapping task while on and off PD medication. This study will look at the differences     between the two sub-types of PD and healthy volunteers.      The investigators will test the hypothesis that connectivity at rest within the motor cortex     and between the motor cortex and motor-associated regions such as the supplementary motor     area and the pre motor cortex will not be as strong in PIGD compared to TD (increased     activity and functional connectivity in TD group)   "
113631|NCT01798550|"     The purpose of this study is to determine an effective enoxaparin dosing strategy in     medically ill, morbidly obese patients. This study will include adult patients greater than     18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable     patients such as prisoners, children, and pregnant women will not be enrolled in the study.     Study participants will be contacted in person by the study personnel once inclusion criteria     are met. Written informed consent will be obtained in person while hospitalized. Once the     patient is consented they will be given enoxaparin and blood samples will be drawn. The data     collected will be from the electronic medical record which is accessed only with a username     and password so it is not publicly available. The data will be identifiable upon collection     and will be kept on a password protected file on a computer in a locked office. The data will     be de-identified after data analysis and only the study personnel will have access to the     code that links identifiers to subjects. A HIPAA waiver will be requested to access existing     data in order to identify patients for enrollment. All data will be collected in an office in     the hospital. The study participants' burden will be minimal and dependent only on time of     consent process since morbidly obese patients would be receiving this blood sample collection     regardless of their participation in the study.   "
113632|NCT01798537|"     A simplified graded gut decontamination protocol combined with rigorous bi-weekly screening     and appropriate bacterial prophylaxis, will lead to a 25% reduction in the acquisition of     blood stream infections and to a 25% reduction in lower airway colonization with multi drug     resistant organisms. There will be no concomitant rise in gram-positive or fungal infection     or a surgency of new resistance patterns.   "
113648|NCT01798329|"     The aim of the study is:        -  Epidemiological/observational: investigating the presence of neuropsychological and          electrophysiological alterations, suggesting a condition of minimal hepatic          encephalopathy(and its behavioral correlates), in childhood and young adulthood affected          by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing          specific diagnostic protocols.        -  Interventional: collecting preliminary data on the effects of a probiotic, in order to          implement a controlled clinical study.   "
113634|NCT01798511|"     Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of     surgeons and gastroenterologists throughout the world. The high rate of pain relapse after     oral refeeding contributes to high consumption of healthcare resources and prolonged hospital     stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration     of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The     potential beneficial effects of enteral tube feeding include induction of postprandial     gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the     risk of pain relapse, thereby shortening length of hospital stay and reducing cost of     treatment. The primary endpoint of the ORION trial will be the incidence of oral food     intolerance. All eligible AP patients will be randomly allocated to either the Early     Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of     hospital admission.   "
113635|NCT01798498|"     The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for     the correction of nasolabial folds.   "
113636|NCT01798485|"     The purpose of this study is to determine whether combining ganetespib (STA-9090) with     docetaxel is more effective than docetaxel alone in the treatment of patients with advanced     non-small cell lung cancer.   "
113637|NCT01798472|"     The aim of this study is to compare the functional and radiological outcome after displaced,     femoral neck fractures treated with either cemented or uncemented arthroplasties.      The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome     at 12 month as the cemented arthroplasty.   "
113638|NCT01798459|"     The purpose of the study is to explore the effect of methylphenidate on state anxiety in     children with attention deficit hyperactivity disorder.      Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The     subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of     age.      Structure: the study is a randomized double blind crossover study. The subjects will complete     a continuous performance test, the cambridge neuropsychological test automated Battery,     before and after given methylphenidate or placebo on the first day of the study. On the     second day of the study, the subjects will receive either methylphenidate or placebo based on     what was given on the first day of the study and they will complete the same task.   "
113639|NCT01798446|"     -  1. There is no standard treatment option for non-clear cell renal cell carcinoma (RCC).        -  2. Patients with non-clear cell RCC is strongly assumed to have benefit from anti-VEGF          treatment.        -  3. There is no trial of axitinib for non-clear cell RCC.        -  4. Axitinib is expected to show more potent efficacy over sorafenib or sunitinib in          renal cell carcinoma.   "
113640|NCT01798433|"     In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective     2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month     target lesion failure after percutaneous coronary intervention for bifurcation lesion.      In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique     with mandatory final kissing ballooning is superior to 1-stent technique without kissing     ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous     coronary intervention for bifurcation lesion.   "
113641|NCT01798420|"     Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to     significantly increase hemoglobin A1C levels   "
113642|NCT01798407|"     This research study will investigate the safety, tolerability, and benefit of bilateral deep     brain stimulation (DBS) to the lateral habenula in subjects with treatment-resistant major     depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD),     or bipolar disorder (BD) I. Six adult subjects with TRD will be treated in this single-site     study at Baylor College of Medicine; subjects will be chronically symptomatic with     significant functional disability, and will have demonstrated resistance to standard somatic     and pharmacotherapeutic treatments. The primary outcome measure will be the change in the     17-item Hamilton Depression Rating Scale (HDRS^17) six months after the commencement of     stimulation.   "
113643|NCT01798394|"     The primary goal of this project is to investigate the potential efficacy of exogenous     progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new     mothers. Also to determine the feasibility of enhanced compliance monitoring and     identification of collateral factors effecting outcomes.   "
113644|NCT01798381|"     The aim of this project is to investigate the effect of a dietary supplementation with     essential fatty acids in adults on cognitive functions related to attention and impulse     control in the general population and in individuals with a diagnosis of attention deficit     hyperactivity disorder (ADHD).   "
113645|NCT01798368|"     The purpose of this study is to demonstrate that the treatment does not cause any clinically     significant effects that would put patients at risk.   "
113646|NCT01798355|"     The purpose of this study is to determine whether cognitive behaviour therapy is effective in     the treatment of children and adolescents with dental anxiety. Our hypothesis is that     children and adolescents who have been offered CBT shows significant better performance on     outcome measures compared with patients in control group who have received treatment as     usual.   "
113647|NCT01798342|"     Carbohydrates (CHO)-based drinks 2h before the induction of anesthesia are recommended to     decrease insulin resistance. The addition of glutamine (GLN) in these beverages may enhance     the benefits of CHO alone. However, only a few studies tested the safety of this formula. The     objective of this study was to evaluate the gastric residual volume (GRV) after the intake of     a beverage containing CHO plus GLN using magnetic resonance (MRI).   "
123270|NCT01672476|"     A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive     Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild     to Moderate Essential Hypertension   "
113650|NCT01798303|"     The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose     of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce     alcohol drinking in these participants. The study will last for 8 weeks.   "
114147|NCT01791764|"     This study has the following objective:      To identify related factors to hospital mortality in patients with ST-segment elevation acute     myocardial infarction submitted to pharmacoinvasive strategy within a structured healthcare     network.   "
113651|NCT01798290|"     Objective: The aim of this study is to assess the impact of an educational program of     Narrative Medicine workshop reading diaries dedicated to medical students on their empathy.      Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of     the University Paris Descartes. Methods: participants will be randomized in 2 groups. The     allocation of participants will be done by a computerized randomization list, the sequence     will be created by an independent statistician. Participants will be blinded of the study     hypothesis. Allocation concealment will be provided because only the statistician will have     access to the randomization list.      A program of Narrative Medicine with lesson in small group of workshop reading patients'     diaries  vs workshop reading literature.      Outcome: The primary endpoint will be a first measure of the empathy of the medical students.     The secondary endpoints will be a second measure of the empathy of the medical student;     satisfaction of the student relative to the educational program .      Potential interests: We believe that the workshop reading patients' diaries can develop the     thinking of the student with respect to his behavior with the patient, and so the relation     between student and patient.      Sample size expected: 200 participants.   "
113652|NCT01798277|"     This study aims to compare antiarrhythmic drug therapy with catheter ablation using the     SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular     tachycardia and coronary artery disease   "
113653|NCT01798264|"     evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.   "
113654|NCT01798251|"     To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of     elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.   "
113655|NCT01798238|"     The study design of this trial is double blind, parallel-group, randomized, placebo     controlled study   "
113656|NCT01798225|"     Our overall hypothesis is that treatment of periodontal disease will produce better diabetes     glycemic control (glycated hemoglobin A1c, or HbA1c) and reduced levels of the catalytically     active form of matrix metalloproteinase (aMMP-8) in the Gullah African American type 2     diabetes patients living on the Sea Islands of the South Carolina coast. The gingival     crevicular fluid (GCF) aMMP-8 levels will be measured through a site-specific, novel     noninvasive technique allowing the pathophysiological status of the periodontium tissue to be     monitored. The investigators will conduct an interventional study on this population with     minimal genetic admixture.   "
113657|NCT01798212|"     A prospective multi center case controlled trial on the clinical feasibility of a new full     thickness endoscopic plication device for patients with GERD.      The primary objective of the present trial is to investigate, clinical feasibility of the     GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary     objective of the trail is to evaluate objective data before and after the procedure, using     manometry and 24h impedeance measurement   "
113658|NCT01798199|"     Virtual environments and information communication technologies (ICT) offer large     perspectives in the field of assistive care and rehabilitation.      As potentially endless, the scenarios and environment used using 3D can provide immersive     social and interactive context for enjoyable and therapeutic exercises in the aging     population. In addition it is also possible to use this type of serious game and scenario in     very easy to use devices such as lap top or tablet.      Social exclusion has many causes, Apathy as one of the most common behavioural disturbances     found in old adults populations alters significantly social and emotional interaction.      Even though, progress in VR has been made over the past year, the presence of such technology     in daily living space is still at the embryonic stage.      The European e-Inclusion policy stresses the importance of ICT in improving the quality of     life in potentially disadvantaged groups, including older people and persons.      The VERVE project is developing ICT tools to support the treatment of people who are at risk     of social exclusion due to apathy associated with a disability.      As people aged and autonomy worsen fear for safety and comfortable means to maintain social     and Health Related Quality of Life (HRQL) status are public health issues.      Moreover, even though older adults would like to perform some activities such as walking in     the streets some are reluctant to go out of their homes as the external environment is     perceived as potentially unsafe.      Apathy, the most common behavioural symptoms in aging population is characterized by symptoms     of reduced initiation and responsiveness to environmental interactions. The syndrome of     Apathy takes form of diminished goal-directed behaviour, characterised by emotional blunting,     loss of initiative and loss of interest. Apathy along with the nosological characteristics of     dementia induces impairment in autonomy level and therefore dependence as cognitive     impairments worsened.      The importance of stimulation could be related to the concept of engagement defined as the     act of being occupied or involved with an external stimulus. Engaging older person with or     without Alzheimer's disease and related disorders in appropriate activities has been shown to     yield beneficial HRQL effects such increasing positive emotion, improving cognition,     functional autonomy and quality of life.      Accordingly, enriched environments with high definition virtual representation of cities and     activities of interest have the potentials not only to encourage patients to get active in a     safe and interactive environment but also to create access to enjoyable and stimulating     settings for the more severe patients.      The VR setting from VERVE proposed personalised and populated environments available on two     different, but interlinked hardware platforms: 1/: standard gaming set-up in the home,     nursing home or day hospital therapy group; and 2/ mobile tracked internet devices     (e.g.,IPad). The system will ensure maximum openness and dissemination by using 3D Web     technologies.   "
113659|NCT01798186|"     This primary aim of this study is to assess the effects of passive (second-hand) inhalation     of cannabis smoke on toxicological analysis of native oral fluid (saliva), urine and blood     specimens. The results of this study will help inform the validity of oral fluid as a     biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation     of cannabis smoke could result in a positive toxicology result.   "
113660|NCT01798173|"     Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well     understood in absence of studies taking into account all recognised factors. A large scale     clinical, biochemical and molecular studies is potentially relevant to the understanding of     nutrition, physical activity, body weight metabolic syndrome whatever the etiology of     underlying cirrhosis. It will open new perspectives :        -  in prevention of hepatocellular carcinoma development in cirrhotic patients through          dietary counselling and therapeutics of metabolic syndrome,        -  in early screening of hepatocellular carcinoma in cirrhotic patients through          spectroscopic technology and later proteomic study resulting in an improvement of          hepatocellular carcinoma prognosis.   "
113661|NCT01798160|"     Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the     treatment of intermediate stage hepatocellular carcinoma.   "
113662|NCT01798147|"     Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the     treatment of intrahepatic cholangiocellular carcinoma (CCC).   "
113663|NCT01798134|"     This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead     transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™     Microspheres to treat hepatocellular carcinoma (HCC).   "
113664|NCT01798121|"     A study to determine bioequivalence of PPD material versus Reference Standard.   "
113665|NCT01798108|"     A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as     Alpharadin), is currently under development. It is an injectable aqueous solution     containing radium-223, a radionuclide that emits radiation of another quality and with a     different distribution than radiopharmaceuticals currently in use.      After injection of the drug into the blood, a large portion of the drug will accumulate in     the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer     in the painful sites of bone than in other sites of the body, and may alleviate pain through     its radiation. Radium-223 is expected to be both efficacious as regards the targeted     localised irradiation, and also to have a favourable safety profile.      The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first     clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of     various radioactivity doses of Radium-223 will be evaluated.   "
113666|NCT01798095|"     Determine if investigational products and reference standard produce similar responses.   "
113699|NCT01797666|"     Objective:      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride     Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing     periods of studies were separated by a washout period of 12 days and 11 days respectively.      Study Design:      Randomized, Two-Way Crossover, Single-Dose, and Open-Label   "
114148|NCT01791751|"     The purpose of this study is to evaluate the effect on LH levels of the 5-day CC     administration during luteal phase in oocyte donors, to investigate whether the CC corrects     the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the     agonist triggered antagonist cycles.   "
113667|NCT01798082|"     Pelvic organ prolapse is a common condition that affects millions of women every year. There     are many options for treatment and it can be difficult to make a decision as how best to     proceed. Previous studies have shown that decisional aids (DAs) may improve knowledge,     physician-patient communication, decisional conflict, and patient satisfaction. However, no     study has evaluated the role of a decisional aid among women presenting for evaluation and     management of prolapse. We would like to determine if a decision aid for prolapse decreases     the amount of decisional conflict women face when choosing a plan of care.      We hypothesize that there will be a difference in the level/amount of decisional conflict     between women who receive a DA and those who do not. Specifically, we anticipate that women     randomized to receiving standard counseling and a DA with have less decisional conflict than     the cohort receiving standard counseling alone.   "
113668|NCT01798069|"     Objective: The aim of this study is to assess the impact of an educational program of     Narrative Medicine workshop reflexive writing dedicated to medical students on the     satisfaction of standardized patients.      Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of     the University Paris Descartes. Methods: Participants will be randomized in two groups. The     allocation of participants will be done by a computerized randomization list, the sequence     will be created by an independent statistician. Participants will be blinded of the study     hypothesis. Allocation concealment will be provided because only the statistician will have     access to the randomization list.      A program of Narrative Medicine in Class-led instruction workshop reflexive writing vs     workshop reading medical publication.      Outcome: The primary endpoint will be the satisfaction of standardized patient relative to     the empathy of the medical students. The secondary endpoints will be the empathy of the     medical students; recommendation of the student by the standardized patients to friends or     relatives; students' satisfaction.      Potential interests: The investigators believe that the workshop reflexive writing can     develop the thinking of the student with respect to his behavior with the patient, and so the     relation between student and patient.   "
113669|NCT01798056|"     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'     HZ/su vaccine in adults with solid tumours undergoing chemotherapy.   "
113670|NCT01798043|"     The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in     cardiac function after 12 months of pacing in patients with pacing leads placed in different     positions within the right ventricle (apically or septally).   "
113671|NCT01798030|"     Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes,     hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed     to sunlight and it is also obtained from the diet and dietary supplements. Older people,     individuals with high skin pigmentation, obese and sedentary individuals have low levels of     Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical     inactivity are associated with reduced exposure to sunlight, and obesity is associated with     the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues     that require its metabolic action. These conditions are also associated with heightened risk     for developing type 2 diabetes, glucose intolerance, hypertension, and     osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in     older women who tend to have increased body fat, are more physically inactive and are at high     risk for central obesity and its metabolic consequences of diabetes, hypertension and     osteoporosis.   "
113672|NCT01798017|"     This open-label study is being conducted to determine whether a mifepristone-misoprostol     regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later     by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for     introduction in public sector facilities in Bangladesh. It will also determine the     feasibility of women availing the option of taking their dose of misoprostol outside the     facility.   "
113673|NCT01798004|"     This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after     chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come     back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops     the growth of tumor cells by stopping them from dividing or killing them. After treatment,     stem cells are collected from the patient's blood and stored. More chemotherapy or radiation     therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are     then returned to the patient to replace the blood-forming cells that were destroyed by the     chemotherapy.   "
113674|NCT01797991|"     This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double     blind pilot study.      The purpose of this pilot study is to assess the feasibility of a trial designed to compare     the quality of life of patients taking dexamethasone in two different ways to prevent     hypersensitivity reactions to paclitaxel.      Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of     life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce     adverse effects compared to dexamethasone given orally 12 hours and 6 hours before     paclitaxel.   "
113675|NCT01797978|"     This study is to see whether the intravenous administration of methylene blue improves the     outcome in severe sepsis and septic shock.   "
113676|NCT01797965|"     The primary objective of the study is to assess the safety and tolerability of long-term     treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants     with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301     (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).      Secondary objectives of this study in this study population are as follows:      To describe MS-related outcomes, including MS relapse, disability progression, MS lesion     formation, and participant-reported impact of MS, following long-term treatment with DAC HYP     To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To     assess the safety, tolerability, and efficacy of switching to DAC HYP in participants     previously on long-term treatment with interferon β-1a (Avonex) in Study     205MS301(NCT01064401).   "
113700|NCT01797653|"     Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with     obstructive sleep apnea (OSA) to define the physiological effects of continuous positive     airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal     microvascular function during a 2 week period.   "
126848|NCT01624740|"     To determine the effects of varying spinal cord stimulation programming parameters, including     stimulation rate, on pain intensity.   "
113677|NCT01797952|"     The study will be conducted at departments of Medical Oncology and Hematology, All India     Institute of Medical Sciences (AIIMS).      Patients with various malignancies who are taken up for high dose chemotherapy followed by     stem cells transplant (blood and marrow transplant) have very high chances of developing     severe oral mucositis (generally 60-80% in different studies and our own previous     experiences). This not only causes significant morbidity but also hampers quality of life     needing use of parenteral nutrition, analgesics, and antibiotics.      No definite treatment exists for prevention or treatment of oral mucositis in this group of     patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth     factor) will reduce duration and severity. Palifermin is very expensive and not available in     country. Recently investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in     reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck     squamous cell cancer patients. (Published online in European Journal of Cancer:     http://dx.doi.org/10.1016/j.ejca.2011.06.010)European Journal of Cancer 2012;4:875-881.No     significant toxicity has been reported with its use.      A pilot study on similar aspect was completed recently at our center(Clinical trial.gov     identifier:NCT 01480011) and in 31 patients who received this only 6 (20%) developed grade     III or IV Mucositis. Now, investigators want to study the efficacy of this drug to reduce     severity of mucositis in patients undergoing myeloablative hematopoietic stem cell     transplantation. The study drug and placebo will be supplied by CD Pharma India Private     Limited.      Investigators further give undertaking that study will be carried as per GCP and declaration     of Helsinki.   "
113678|NCT01797939|"     Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease     (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that     depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses     to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still     remain controversial. Therefore, the aims of this study were to investigate the efficacy of     PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic     GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS),     Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and     depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).   "
113679|NCT01797926|"     This is a three-period, three sequence, reference replicated, cross-over study to determine     the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and     FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and 100 mg losartan) to reference amlodipine     and losartan tablets co-administered in two groups enrolling 102 healthy adult male and     female subjects under fasting conditions.      A description of each treatment is provided below:      A (Reference) = 1 x 5 mg amlodipine tablet and 1 x 50 mg losartan tablet. B (FDC5/50) = 1 x 5     mg amlodipine and 50 mg losartan tablet C (Reference) = 1 x 5 mg amlodipine tablet and 1 x     100 mg losartan tablet D (FDC5/100) = 1 x 5 mg amlodipine and100 mg losartan tablet The     treatments will be administered in accordance with the randomisation schedule as.      Group 1: A → A → B or A → B → A or B → A → A Group 2: C → C → D or C → D → C or D → C → C All     subjects will attend a screening visit within 28 days of their first dosing period (Day 1).     The baseline assessments will be conducted the day before the first dosing.      In each treatment period, subjects will be admitted to the clinic in the evening before Day     1. All subjects will receive a single oral dose of amlodipine and losartan in the morning on     Day 1. All the subjects will remain in the clinical unit until completion of all assessments     at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample.     Subjects will return to the clinic for pharmacokinetic samples at 36, 48, 72 and 96 hours     post-dose.      The three treatment periods will be separated by a washout period of 10-17 days. Upon     completion of the last dosing period, or early withdrawal, subjects will return to the     clinical unit within 14-21 days for a follow up visit.   "
113680|NCT01797913|"     assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced     non-small cell lung cancer   "
113681|NCT01797900|"     The purpose of this study is to determine whether Intensity-modulated radiation therapy     (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin     and paclitaxel) is feasible and effective than current standard treatment for high-risk     locally advanced NPC patients.   "
113682|NCT01797887|"     Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling     compared to conventional standard diet and lifestyle counseling in outpatient mothers with     burnout-syndrome.   "
113683|NCT01797874|"     To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.   "
113684|NCT01797861|"     Chronic central serous chorioretinopathy (CSC) is a relatively frequent eye disease that     often occurs in patients in the professionally active age range. In this disease, there is     pooling of fluid under the central retina (the macula). This specific form of macular     degeneration can cause permanent vision loss, image distortion, loss of color and contrast     vision due to this fluid under the retina. An early diagnosis and treatment may improve the     visual outcome and quality of life. To date there is no international consensus on the     optimal treatment of chronic CSC. Many retrospective studies suggest that treatment with     photodynamic therapy (PDT) is effective in chronic CSC. Micropulse laser (ML) therapy may     also be effective in this disease.      The proposed study is the first prospective randomized controlled trial in chronic CSC. In     this study, participants with chronic CSC will be randomized into two treatment groups, PDT     or ML treatment. The trial is a superiority study, because retrospective studies suggest that     PDT treatment may be more effective than ML treatment. Therefore, PDT treatment is challenged     against ML treatment.      The null hypothesis of the study is that PDT treatment is more effective than ML treatment in     patients with active chronic CSC. The alternative hypothesis is that PDT treatment is not     more effective than ML treatment in these patients.      Treatment success will not only be based on anatomical improvement, but also on functional     endpoints, which are most important from a patient's perspective.      The study will take place in five large tertiary referral university hospitals in Europe that     have extensive experience with conducting clinical trials (in Nijmegen, the Netherlands;     Cologne, Germany; Leiden, the Netherlands; Oxford, United Kingdom; and Paris, France). Each     of these centers has confirmed sufficient funding to conduct the research. The study will     last max. 8 months per participant. Each participant will come for 5 (in the case of 1     treatment) or 7 visits (in the case of 2 treatments). Study evaluations will be mostly part     of regular clinical care. The whole study will last for max. 24 months.   "
113685|NCT01797848|"     The purpose of this study is to determine whether 24 week treatment with the Daclatasvir     (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is     safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24)     (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks     of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects   "
127405|NCT01617447|"     The objective of this study is to investigate the efficacy and safety of aripiprazole orally     administered over a period of 8 weeks in pediatric patients with Autistic Disorder   "
113686|NCT01797835|"     Screening youth in the primary care setting is one way to identify adolescents who may be     at-risk for future alcohol problems. The current study tests the new NIAAA screening guide     questions, which ask about friend and adolescent drinking, to see how well these questions     work to predict subsequent alcohol use, problems, and involvement in other risk behaviors,     such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a     brief motivational intervention for some at-risk teens and see whether alcohol use differs     for those teens who receive the intervention and those teens who receive enhanced usual care.     The results of this study have the potential to significantly impact the standard of care for     identifying and intervening with at- risk youth in primary care settings.   "
113687|NCT01797822|"     The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the     counter artificial tears and the prescription eye drop, dexamethasone, change or effect the     eyes response to a low humidity environment.      It is known that irritation from dry eye can be improved by over the counter artificial tears     because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can also     improve eye irritation by decreasing the inflammation that develops in dry eye. Thus, the     investigators hypothesize that the use of these conventional dry eye treatments will improve     the eyes' response to a low humidity environment.   "
113688|NCT01797809|"     The objective of this PMS is to gain information about safety and efficacy in real practice     as a regulatory commitment required by KFDA(Korea Food and drug administration)   "
113689|NCT01797796|"     The purpose of this study is to examine the effect of PF-06305591 on capsaicin and     capsaicin/heat-induced neurogenic flare.   "
113690|NCT01797783|"     The purpose of this study was to demonstrate substantial equivalence of the new DAILIES®     AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus®     DAILIES® Progressives (FDP) contact lens.   "
113691|NCT01797770|"     This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal     Surgery. In this trial patients with left sided colon and rectal tumors were randomized to     receive mechanical bowel preparation or no preparation to assess postoperative complications     and outcome   "
113692|NCT01797757|"     A potential application for unstructured monoacylglycerol (MAG) containing long chain     polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who     chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed,     it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty     acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source     of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other     type of maldigestion/malabsorption. Potential applications of such concept are therefore     related to disease conditions comprising low lipid digestion due to lipase activity     insufficiency.      In the present study, in order to see the response information for eicosapentanoic acid (EPA)     delivery, EPA will be provided either as a mixture of free monoacylglycerols or as     triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under     Orlistat® consumption will be analyzed.   "
113693|NCT01797744|"     Recently, the investigators has shown that dizziness is common among patients with first time     stroke and that it affects self perceived health. There are indications that vestibular     rehabilitation can have effect of neurological causes of dizziness and vertigo and it     therefore seems important to find out if vestibular rehabilitation can affect dizziness among     patients with stroke.      The aim of this study is to find out if vestibular rehabilitation can have any effect on     function, balance and self-rated health among patients with first time stroke.   "
113694|NCT01797731|"     This is a randomized, controlled, blinded prospective study comparing the use of the usual     cutting guides with a palm-sized digital surgical navigation system in unilateral total knee     arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of     the tibial (shinbone) implant components. The investigators expect that the FDA-approved     hand-held surgical navigation device will increase the accuracy and precision of the tibial     cut by telling the surgeon the exact position of the cutting block before the surgeon makes     the cut, allowing minor adjustments to be made. The investigators expect the conventional     device to take less time to use, but that this difference will decrease as the surgeon     becomes more familiar with the device. The investigators expect the intraoperative     measurements acquired by the KneeAlign system to strongly correlate with the radiographic     alignments measured postoperatively.   "
113695|NCT01797718|"     Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based     effective and safe treatment option. This study compares the effects of low-dose testosterone     and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys     CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster     biochemical and clinical progression of puberty as compared to low-dose intramuscular     testosterone Rx (~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful     waiting instead of medication will provide background data on the natural progression of     CDGP, and their data will not be used in primary statistical comparisons.   "
113696|NCT01797705|"     The purpose of this protocol is to improve the current FDA-approved continuous positive     pressure auto-titration algorithm, including treatment precision, residual disease detection     characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.   "
113697|NCT01797692|"     This is a multicenter pilot study, proposed for cases and controls 3 departments in France.      Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are     healthy subjects selected by lottery on voter list.      Volunteer subjects (cases and controls) are offered a consultation and assessment with an     geriatrician.   "
113698|NCT01797679|"     This study is the radiological component of an earlier registered RCT under the title:     Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee     Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy     of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the     articular cartilage. It has been proven that exercise can improve function and reduce the     need for analgesics in patients with osteoarthritis. With this study, we wish to investigate     if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation     times of the articular cartilage, and also if this improvements are transient or permanent.   "
113701|NCT01797640|"     Currently, the treatment of choice for tibial fracture is intramedullary nailing. This     procedure has been shown to have low rates of infection, high rates of bone healing, and a     faster return to weight bearing and activity in comparison to conservative treatment. In     concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to     identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the     tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures     prior to tibial nailing is a safe treatment in which the reduction of the malleolus is     maintained intraoperatively, postoperatively, and remains reduced until the fracture has     healed.   "
113702|NCT01797627|"     This multicenter, prospective study of children with hydrocephalus will examine whether or     not ventricle size is associated with poor cognitive outcomes. It is expected that results     will indicate larger ventricular size at 6 months after surgery for the initial treatment of     hydrocephalus will relate to poorer cognitive outcomes. This study is being conducted by the     Hydrocephalus Clinical Research Network (HCRN), a network established to conduct     multi-institutional clinical trials on pediatric hydrocephalus.   "
113703|NCT01797614|"     Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is     studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can     also reflect the change of pulmonary dynamics. In this study, we choose patients who received     spontaneous breathing trial to answer the hypothesis.   "
113704|NCT01797601|"     The purpose of the study is to investigate whether insulin sensitivity and insulin resistance     of the human brain is comparable in all insulin sensitive parts of the brain and whether     correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of     the study participants.   "
113705|NCT01797588|"     Effective pain management following total knee arthroplasty is important to facilitate early     mobilization and rehabilitation. To manage post-operative pain, multimodal analgesia,     including acetaminophen, NSAID's, gabapentin, opioids and local anesthetics are used.     However, local anesthetics injected into the femoral nerve area may cause a block in motor     function of the quadriceps muscle. Both adductor-canal peripheral nerve block performed     pre-operatively, and periarticular infiltration performed intra-operatively are effective in     reducing pain following TKA without causing quadriceps motor block which can impede     mobilization. No published trials have been found that compare single shot adductor-canal     block plus periarticular infiltration to periarticular infiltration only or adductor-canal     nerve block only. The purpose of this trial is to examine the effect of 3 different     approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2)     adductor-canal block only; 3) periarticular infiltration only, on pain, analgesic     consumption, mobility, pain related interference with activities and length of hospital stay     in participants undergoing unilateral TKA. Patients will be eligible for participation if     they are 18 years old or older, and can speak, and read English. Ninety-six trial     participants will be randomized to receive 1 of the 3 approaches to nerve blockade as part of     their pain management plan. Outcomes will be measured on post-operative days 1 and 2 and     length of stay will be calculated in hours after the participant is discharged to home. It is     hypothesized that participants that receive both adductor-canal nerve block plus     periarticular infiltration will report less pain, improved mobility and less pain related     interference with activities.   "
113706|NCT01797575|"     We propose to conduct a double-blind placebo-controlled trial with a widely available and     prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC,     involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed     episode currently. This will be the first controlled study to test the hypothesis that     aspirin and NAC, by themselves or in combination, will be beneficial in treating depression     in bipolar disorder patients and in promoting mood stabilization.      Our study has the following Aims:      Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a     double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating     depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III -     Examine efficacy of combined treatment with aspirin and NAC looking for synergistic,     potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible     mediators or modulators in therapeutic response in the treatment of depression in patients     with Bipolar Disorder.   "
113707|NCT01797562|"     To evaluate the performance and safety of seven T.R.U.E. Test Panel allergens in subjects     6-17 years of age with suspected contact dermatitis.   "
113708|NCT01797549|"     The goal of this project is to develop a test to assess frontal lobe function using a rapid,     inexpensive, objective, and standardized method, without the need for expertise in cognitive     test administration. Such methods would be particularly helpful in traumatic brain injury     (TBI), where objective measures are needed, and would greatly expand the capacity to make     such assessments in clinical practice and research.   "
113709|NCT01797536|"     The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir     (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic     insufficiency compared with healthy controls.   "
113710|NCT01797523|"     The goal of this clinical research study is to learn if the combination of everolimus,     letrozole, and metformin can help to control recurrent or progressive endometrial cancer. The     safety of this drug combination will also be studied.      Everolimus is designed to block a protein inside cancer cells that is involved in cancer     growth.      Letrozole is designed to block a protein from making estrogen. This may interfere with the     growth of cancer cells.      Metformin is commonly used to control blood sugar levels in patients with diabetes. It is     designed to lower insulin levels, which may slow or stop the growth of endometrial cancer     cells.   "
113711|NCT01797510|"     This study is designed to compare an intensive lifestyle and activity coaching program     (&quot;Sessions&quot;) to usual care for diabetic patients who are sedentary. The question to     be answered is whether the Sessions program improves clinical or patient centric outcomes.      Recruitment is through invitiation only.   "
113804|NCT01796301|"     The primary objective of the study was to evaluate the effect of 12 months of treatment with     romosozumab compared with teriparatide on total hip bone mineral density (BMD) in     postmenopausal women with osteoporosis who were previously treated with bisphosphonate     therapy.   "
113712|NCT01797497|"     The overall goal of this three-year study is to adapt and test a brief, feasible intervention     using a communication tool and brief parent coaching to increase the capability of parents of     children and youth with special health care needs to exchange and use medical information in     partnership with their child's physicians when their children require sub-specialty referral.     We hypothesize that the use of tools to coordinate referrals between physicians and parents     will facilitate increased communication between primary care physicians(PCPs) and     specialists, and that parents trained in information exchange and care planning will     experience increased self-efficacy in interacting with their child's physicians.      There are two primary aims of the study. The first aim is to adapt a joint parent-provider     referral communication and care planning intervention (i.e., the 'referral care plan') for     use with ethnically diverse populations in an electronic communication environment, and     optimize its usability in the practice setting. The second aim is to test the referral care     plan in nine pediatric primary care and subspecialty practices in two states, using a stepped     wedge cluster randomized trial, to evaluate its effect on communication, parent     self-efficacy, and patient outcomes.   "
113713|NCT01797484|"     The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in     acute myocardial ischemia.      A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of ischemic     myocardium in patients with stable coronary artery disease can be reduced by     Ranolazine-treatment2. This effect was shown by significantly reduced areas of atypical or     dysfunctional myocardium in SPECT-examinations.      The dimension of myocardial damage (i.e. area of ischemic myocardium) is directly related to     the rate of complications (i.e. left-ventricular pump failure, malignant arrhythmia) and the     grade of Rehabilitation to daily life (i.e. persistent reduced left-ventricular ejection     fraction).      In patients with stable angina pectoris, Ranolazine is used with beneficial results1.     Ranolazine improves diastolic blood flow and therefore microcirculation in the myocardium by     reducing diastolic tension (via inhibiting late Na+-Influx and consecutive Ca2+-Overload).      Recently published data2 showed that treatment with Ranolazine significantly reduces the     ischemic area in chronic damaged myocardium. This is due the effect of improved     microcirculation in hibernating myocardium.      Early administration of Ranolazine and improvement of microcirculation in patients with acute     damaged myocardium (i.e. directly after acute ischemia) should lead to a recruitment and     re-uptake of cardiac activity of hibernating myocardium.      For the RIMINI-Trial patients are given Ranolazine on top of the guideline-based treatment to     reduce the area of acute ischemic myocardium.      Patients with unstable angina pectoris and proof of acute cardiac ischemia, proof of     myocardial dyskinesia and angina pectoris in the patient history will receive unaltered     guideline-based therapy for acute cardiac ischemia5,6. All necessary procedures will be     performed to stabilize patients to a hemodynamically compensated state and patients are then     transferred to receive cardiac catheterization (angiography and angioplasty if necessary).      After patients are stabilized Ranolazine will be given additionally to guideline based     medication.      The measurement of the ischemic myocardial area will be done via three functional     echocardiographies with speckle tracking technique10.      A statistical evaluation of ischemic myocardial area before and after treatment with     Ranolazine/Placebo will be done after conclusion of the RIMINI-Trial to show the effect of     Ranolazine in acute myocardial ischemia.   "
113714|NCT01797471|"     The investigators aim to evaluate the safety of delivering a one-time single fraction of     Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose,     conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in     patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase     I clinical trial. The investigators hypothesize that the addition of a one-time single     fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity     above that expected with standard-dose concurrent chemotherapy and radiation alone.   "
113715|NCT01797458|"     The purpose of this randomized clinical trial is to compare the clinical effectiveness of     three treatments involving different caries management strategies (conventional restorations,     Hall technique, and a non-restorative treatment of dental caries) to the management of class     II carious primary molar in children 3-8 year-old from three different countries (Scotland,     Lithuania, and Germany).   "
113716|NCT01797445|"     This study will evaluate the efficacy and safety of     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose     combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate     (Stribild®; E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.   "
113717|NCT01797432|"     The investigators hypothesize that Restylane® could serve as a repair matrix which also     maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of     time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting     the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with     IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the     prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone     acetonide for longer periods of time, patients may see a better clinical response for a     longer period of time. Quality of life may improve as the number of clinic visits decreases     as would the number of IL corticosteroid injections.   "
113718|NCT01797419|"     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of     GS-5806 in hospitalized infants with RSV.   "
113719|NCT01797406|"     Water injection colonoscopy has been a generally accepted method in training the beginners of     colonoscopy for its low pain and less cecal intubation time, the investigators would conduct     this study to investigate advantages of this method for experienced endoscopists.   "
113720|NCT01797393|"     Up to now, many studies has showed that compared with air insufflation colonoscopy,     water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the     patients,especially for training the beginners,the investigators conduct this study to     preform the air assisted water injection colonoscopy in experienced endoscopists.   "
113721|NCT01797380|"     To determine the efficacy of escitalopram in treating depression in HIV seropositive women.   "
113722|NCT01797367|"     The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500     cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') slows the rate     of decrease in lung function over time compared to waiting to start ART until the CD4+ drops     below 350 cells/mL ('deferred ART group'). Lung function normally declines with age, and both     human immunodeficiency virus (HIV) infection and ART have been shown to case a decline in     lung function as well. Decline in lung function can be an early indicator of chronic     obstructive pulmonary disease (COPD), a significant cause of sickness and death in people     with HIV. In this study, lung function will be measured at baseline and every year thereafter     by using a spirometer.   "
113877|NCT01795339|"     This is a two-part multiple dose study in healthy male and female (of non-child bearing     potential) elderly volunteers, and in Alzheimer's disease patients, to assess the safety,     effects on the body, and blood, CSF, and urine drug levels of AZD3293. AZD3293 is being     developed for the treatment of Alzheimer's Disease   "
113878|NCT01795326|"     A physician survey to document receipt of metabolic educational materials and assess behavior     of physicians in following messages communicated through the educational materials   "
113723|NCT01797354|"     Background: The end of treatment is for cancer patients the beginning of a critical     rehabilitation period including numerous physical, emotional, professional and cognitive     challenges. Specific interventions adapted to this post-treatment period need thus to be     designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been     shown to be effective. However, moderate effect sizes, no comprehensive description of the     treatment interventions and assessments relying only on self-report measures warrant further     investigation. This study aims to assess, in breast cancer patients at the end of treatment,     the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus     a group intervention on patient's adjustment and emotion self-regulation.      Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer     patients finishing their radiation therapy treatment will be randomized to either an     immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group     intervention. Patients will be assessed at three time points during the first year following     the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment.     Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation     ability will be assessed through their ability to respond both subjectively (self-reported     emotional state) and objectively (heart rate) to two emotion self-regulation tasks.      Discussion: It is hypothesized that a group intervention combining cognitive-behavioral     therapy and hypnosis will be more effective than a group intervention. Results of this study     will contribute to improving post-treatment care for breast cancer patients.   "
113724|NCT01797341|"     The present study is aimed at evaluating the impact of a switch from Prograf to Advagraf on     renal function, trough tacrolimus levels, drug-related adverse effects and adherence in     stable recipients of kidney-pancreas transplants. MPA pharmacokinetics will also be     evaluated. The results of this study have the potential to change current practice.   "
113725|NCT01797328|"     About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of     ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for     determination of brown adipose tissue volume) imaging are performed before and after the     study.   "
113726|NCT01797315|"     Transplant recipients have a high risk to develop skin malignancies. This effect depends on     the one hand on the immunosuppressive drugs themselves and relates on the other hand on the     dosage. Based on the encouraging results of previous, retrospective studies on patients     treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive     regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from     former immunosuppression. A conversion to a SRL-based therapy is effective in     immunosuppression and safe regarding graft and patient survival.      This study was designed to assess whether a switch to a SRL-immunosuppressive therapy     decreases the incidence/reoccurrence of skin neoplasm.   "
113727|NCT01797302|"     In this study, we will test the central hypothesis that enhancement of vitamin D status in     obese and overweight children will improve their vascular health and their cardiovascular     disease (CVD) and metabolic syndrome risk profile.   "
113728|NCT01797289|"     All patients consecutively referred with the first episode of transient and short-lasting     loss of consciousness will have a diagnostic workup for the assessment of the most common     causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the     use of an internationally accepted algorithm including a pre-test clinical probability (PTP     according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay.     If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo     confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung     scanning) in order to confirm or rule out the presence of PE.   "
113729|NCT01797276|"     Expanded access to DCA as continued treatment for congenital lactic acidosis.   "
113730|NCT01797263|"     The Pain Outcomes comparing Yoga versus Structured Exercise (POYSE) Trial is a 2-arm parallel     group, randomized clinical trial to compare the effectiveness of a yoga-based intervention     (YOGA) with that of a structured exercise program (SEP) for subjects with fibromyalgia. The     study aims are: 1) to compare the interventions' (YOGA vs. SEP) effects on overall     fibromyalgia severity at 1 month (early response), 3 months (immediate post-intervention) and     at 6 and 9 months (sustained effects); 2) to compare the interventions effects on specific     fibromyalgia symptoms (pain, sleep, and fatigue), functional impairment, and related outcomes     (quality of life, psychological symptoms); and 3) to compare the cost-effectiveness of the     interventions.   "
113731|NCT01797250|"     To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population   "
113732|NCT01797237|"     The purpose of this study is to determine whether this two intramedullary fixations are     effectively in the treatment of intertrochanteric fracture.   "
113733|NCT01797224|"     The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic     effect of these medications and to follow live born infants for five years after birth. With     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be     relevant to a medication exposure during pregnancy, and these include both easily     recognizable defects which are visible at birth, as well as more subtle or delayed defects     that may not be readily identifiable without special expertise and observation beyond the     newborn period.   "
113734|NCT01797211|"     To assess the effect of Mediterranean diet and some of its specific components (olive oil,     non fried fish and nuts) on endothelial function in overweight and obese patients   "
113735|NCT01797198|"     ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a     two-part study to investigate the drug-drug potential of ASP3652.      Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of     ASP3652.      Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of     repaglinide.      Subjects participating in one part of the study may not participate in the other part.   "
113736|NCT01797185|"     Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis   "
113879|NCT01795313|"     The purpose of this study is to see if vaccination with HLA-A2 restricted peptides, combined     with the immunoadjuvant imiquimod is safe and can induce immune responses in children with     recurrent ependymomas. Eligible patients are stratiﬁed by primary tumor location.   "
113737|NCT01797172|"     Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral     medications. Once these treatments have failed, different alternative procedures can be     applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical     Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of thermal     damage. A variety of published studies have demonstrated this treatment to be both safe and     effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is also a     popular type of pain treatment. The application of PRF is also a safe and useful intervention     for neck pain. Although these treatment types are described in the literature, the available     evidence for efficacy is not sufficient to allow definitive conclusions on the optimal     therapy to be made. The purpose of this study is to investigate which technique is the most     effective in terms of pain relief on short term in patients with contained cervical disc     herniation: PCN or PRF?   "
113738|NCT01797159|"     The Investigators are looking to compare standard treatment for the management of small cell     lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in     patient survival) with cranial sparing PCI. Although standard of care PCI is successful in     patient survival it also has neurologic side-effects. The Investigators are hoping the     cranial sparing PCI has the same positive survival results with the added benefit of lowering     neurological side-effects.   "
113739|NCT01797146|"     The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy     of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use     and the number of infection relating to catheter use.   "
113740|NCT01797133|"     We will conduct a cluster randomized controlled trial to compare two antibiotic     pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and     duration of antibiotic consumption would be lower in the pharmacist group while the clinical     outcome would be equivalent between two groups.   "
113741|NCT01797120|"     Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant     to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with     Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).      Fulvestrant has demonstrated activity when used as first, second, or third line endocrine     therapy, making it an attractive therapy for combination with other agents. In addition, it     is commonly reserved for use following disease progression on AI therapy.      Everolimus is an orally administered drug that blocks a signaling pathway called mTOR.     mTOR acts as a regulator for many processes in the body, including cell growth. Blocking     this pathway may have an effect on cell growth.      The combination of a novel class of agents (mTOR inhibitors) and an established standard     treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by     targeting multiple different biological pathways.   "
113742|NCT01797107|"     The purpose of this study is to evaluate the effect of Azasite on patients with corneal     surface irregularity (meibomian gland dysfunction).   "
113743|NCT01797094|"     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the     treatment of upper facial lines (Crow's Feet Lines and Frown Lines).   "
113744|NCT01797081|"     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared     to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).   "
113745|NCT01797068|"     A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is     to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED)     visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported     health status, quality of life, access/barriers to care) among Medicaid patients who are high     utilizers of the ED, as well as to identify best practices for engaging and providing     healthcare services to underserved patients using patient navigation. This study will address     needs that have been identified within the New Haven community and the local healthcare     system, contribute to knowledge and literature surrounding the use of patient navigation to     improve care for underserved patients and improve health system efficiency, and inform the     design and development of programs that address these needs both locally and in other     communities.   "
113746|NCT01797055|"     Atransferrinemia is a very rare disorder, which is caused by a deficiency of the protein     transferrin. No regular treatment is available for these patients. The objective of this     study is to investigate the pharmacokinetics, efficacy and safety of Apotransferrin     replacement therapy in atransferrinemia patients.   "
113747|NCT01797042|"     The purpose of this study is to investigate the acute and chronic effects of consumption     fructose containing sugars and glucose in a real word setting when consumed in a manner and     amount typical in the American diet.   "
113748|NCT01797029|"     This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial     of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated     influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh.      Background:        1. Burden: Within Bangladesh, community- based influenza surveillance identified 84.5          cases/1000 children-years among children <5 years, while 10% of clinical pneumonia cases          were influenza positive in this age group.        2. Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL          LAIV vaccine conducted among children in a low-income country.        3. Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high efficacy          against laboratory-confirmed influenza among children. The SIIL LAIV has the potential          to be an inexpensive intervention to prevent pediatric influenza disease.      Primary Hypothesis: In children aged 24 through 59 months in Bangladesh, LAIV is efficacious     in reducing rates of symptomatic, laboratory-confirmed influenza (vaccine-matched strains)     among children vaccinated with LAIV as compared to children vaccinated with a placebo through     the first influenza season following vaccination.      Primary Objective: To determine the efficacy of LAIV in reducing rates of symptomatic,     laboratory-confirmed influenza virus infection (vaccine-matched strains) among children     receiving LAIV as compared to children receiving a placebo through the first influenza season     following vaccination (through December 2013).      Methods: A total of 1761 children will be enrolled and randomized in a 2:1 ratio of LAIV to     placebo beginning in March 2013. After vaccination, all children will be evaluated for     reactions with one home visit four days post vaccination. Subsequently, all children will be     monitored weekly for safety outcomes and illness signs at weekly field worker home visits     through December 2013. An extended surveillance period was added to this study and, for     participants consenting to additional follow-up, surveillance will extend through a second     season (through September 2014). Participants with illness signs will be referred to the     study clinic for evaluation using standardized diagnostic criteria and treatment by a study     physician. Children meeting protocol-defined clinical Specimen Collection Criteria will have     a nasopharyngeal wash specimen collected. Clinical specimens will be tested by Real time     polymerase chain reaction (rRT-PCR) for evidence of influenza virus infection.      Primary Outcome measures/variables: Vaccine efficacy will be assessed against symptomatic,     laboratory-confirmed influenza for all circulating virus strains.   "
114210|NCT01790945|"     The purpose of this study is explore if a partnership and screening program put in place     between a busy retina practice and their referring diabetes care offices can improve diabetic     retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in     patients with diabetic eye disease.   "
113749|NCT01797016|"     This project aims to refine previous studies including the investigators work recently     published in August 2012 Journal Thrombosis and Thrombolysis. That study showed a     relationship between the level of platelet leukocyte aggregates in patients with acute     coronary syndrome. The investigators intend to compare the characteristics of platelets,     monocytes and neutrophil data of volume, scatter and conductivity obtained from routine blood     count level with flow cytometry results defining platelet leukocyte aggregates. The     investigators hypothesize that there will be a direct correlation between elevated     platelet-leukocyte aggregates and biophysical data from the blood count.   "
113750|NCT01797003|"     Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for     treatment of medial knee osteoarthritis.      Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We     will compare functional results and patient satisfaction with repetitive evaluations from     preoperatively to 2 years postoperatively.   "
113751|NCT01796990|"     The main objective of the study is to provide data of the effectiveness and feasibility of     the Acceptance and Commitment Therapy in enhancing the physically active lifestyle among     sedentary adults. The psychological and motivational factors related to physical activity and     behavior change will also be evaluated.   "
113752|NCT01796977|"     This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound     complication rates of the nipple areolar complex after a nipple sparing mastectomy.   "
113753|NCT01796964|"     The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in     the treatment of exudative age-related macular degeneration.   "
113754|NCT01796951|"     Regular aspirin use has been associated with a reduction in the development of a number of     different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is     not known. This study will evaluate whether once daily aspirin use can reduce the production     of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically,     this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme     named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either     aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various     days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4     timepoints in this 16-day study.   "
113755|NCT01796938|"     To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired     subjects and healthy subjects.   "
113756|NCT01796925|"     The objective of the study is to confirm the safety and efficacy in patients utilizing the     aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).   "
113757|NCT01796912|"     Angina which is refractory to conventional medical therapy and revascularisation is     challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of     LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse     cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic     effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most     effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no     effect on Lp(a) levels.      The goal of this study is to determine the impact of apheresis on clinical parameters and     symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct     a prospective, randomised controlled crossover study of 20 patients with refractory angina     and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or     sham apheresis weekly for three months with assessment of myocardial perfusion, carotid     atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina     symptoms and quality of life at the beginning and end of treatment. Patients will then     crossover to the opposite study arm with the protocol repeated. The hypothesis is that the     above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and     Refractory Angina. Investigators will also test for the genotypic presence of     apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to     be associated with an increased level of Lp(a) and an increased risk of coronary disease.   "
113758|NCT01796899|"     To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg,     75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.   "
113759|NCT01796886|"     The pupillary examination is a major component of the clinical examination and monitoring of     brain-damaged patients in intensive care. The occurrence of abnormal size or pupillary     reactivity is a prognostic factor of poor neurological outcome or an indicator of the     neurological status degradation. To date, the monitoring of the pupils is clinical. The     subjectivity of this measure and, the lack of reproducibility and definition of the     abnormality remain as many obstacles to the development of a monitoring of early neurological     deterioration. The recent development in pupillometer electronics allows the assessment of     responsiveness to a calibrated light stimulus. It offers a reliable and reproducible measure     of the pupil diameter. The pupillometers were funded by the association of  Gueules Cassées     .      This study aims to establish a relationship between an abnormal pupillary reactivity     detection by the electronic pupillometer and a deterioration in neurological status of the     patient brain-damaged in the intensive-care unit (ICU). This is considered clinically     relevant and has been defined by a lower Glasgow Coma Score of at least 2 points for 2 hours     or involving a therapeutic action. If this relationship is demonstrated, the temporal     relationship between data pupillometry and the patient's neurological status remain to be     established more precisely. This is particularly relevant in neurosurgical context and aim to     define the status of the electronic pupillometer in intensive care but also in emergency     rooms services, the neurovascular units or in the pre-hospital care.      Therefore the investigators will compare the pupillometry data in two patients groups,     defined accordingly to the appearance or absence of neurological aggravation in the first 5     days of treatment in intensive care, time-frame defined as the maximum risk period in     patients with brain damage. The primary endpoint is represented by the estimated area under     the ROC curve corresponding to the last measure of the change in pupil size before the onset     of neurological deterioration and worse for the fifth day for non-aggravated.      Thus the investigators propose to conduct a prospective trial, aiming to record the     diagnostic value of pupillary reactivity by the electronic pupillometer in the monitoring of     the neurological aggravation of brain damaged patient in ICU. The duration of the follow-up     for a subject does not exceed 5 days. The statistical analysis requires the recruitment of 90     patients, which sets the length of the inclusions to 14 months.   "
113760|NCT01796873|"     Plavix (clopidogrel) is a drug that is approved by the FDA (Food and Drug Administration) to     reduce the risk of having another heart attack by preventing platelets (blood cells that are     important in forming blood clots) from sticking together and forming another clot. Platelet     activity can be measured by a machine called VerifyNow.      The purpose of this study is to see whether Hispanic women and White non-Hispanic women have     the same platelet response to a commonly used drug, Plavix (clopidogrel). Recent studies have     shown that platelets may be more active in Hispanics, making it more difficult to prevent     clots from forming, even when using Plavix. In addition, studies have shown that women may     also have more active platelets than men. There have been no studies of Hispanic women and     the effect of Plavix on platelet activity.   "
113761|NCT01796860|"     The purpose of this study is to investigate the impact of a specifically designed ankle foot     orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and     temporal gait parameters, electromyography (EMG), and walking endurance, in select     individuals living with MS. This orthotic is fabricated to allow ankle range of motion     required for normal gait kinematics. Additionally, it controls forward progression of the     tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are     fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2.     Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and     3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing     profiles/EMG measures.   "
113762|NCT01796847|"     Glycemic variability in critically ill patients is a recognized negative prognostic factor.     The molecular mechanisms determining inter-patients variability in glucose metabolism during     stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to     influence glucose homeostasis by interfering in intracellular insulin signaling.      Aim of this study is to ascertain whether differential expression of PTEN in critically ill     patients correlates with glycemic variability and clinical outcome.   "
113763|NCT01796834|"     To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction     (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure,     perceived stress, depression, patient self-efficacy and quality of life; and to estimate the     effect of a MBSR program for patients with DM. It is expected that MBSR program participants     will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and     standardized measures of diabetes self-management, perceived stress, depression,     self-efficacy, and quality-of-life.   "
113764|NCT01796821|"     To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline     EGW(s) on the treated area.   "
113765|NCT01796808|"     It is believed that the average person with an eighty year old life span will walk the     distance of the world twice in their lifetime. The foot is comprised of a specialized fat pad     to provide shock absorption and protection against breakdown. With all the walking humans do     however, foot fat pad breakdown is inevitable. Trauma to the foot is compounded in the     diabetic patients due to many reasons: loss of protective sensation secondary to neuropathy,     reduced skin hydration, decreased soft tissue elasticity, elevated blood sugars and increased     body weight to name a few. Increased foot pressure and decreased fat pad protection are the     main contributing factors to callus formation, foot pain and ulcer formation.      Fat grafting is a cosmetic and reconstructive procedure that is used sometimes to help     improve one's soft tissue thickness, shape and integrity. Autologous fat transplantation is a     procedure using a patient's own fat that is taken by a small liposuction tube, from areas     with a substantial amount of fat ( i.e. abdomen or thighs) and then transferred into the fat     atrophied (decreased or worn out) area (in this case, the foot).      The investigators are performing this research in an effort to decrease foot pressure during     activity and to increase the soft tissue thickness of the sole of the foot during one's     lifetime. Ultimately this could help reduce foot pain, callus formation and even ulcer     formation. The goal of this research is to see whether fat grafting will help decrease the     prevalence of the aforementioned foot complications. The investigators hope that by using     one's own fat tissue, he or she may have a longer duration of relief than by using other     methods.      This is a randomized, cross-over designed study. Randomized means that patients will be     enrolled by chance (like the flip of a coin) to one of two groups for the first part of the     study. Cross-over means that, after the first part of the study or at one year, patients will     move into the opposite group. One group will receive the fat grafting procedure with one year     follow up (year A pathway) and the other will receive standard of care treatment from the     patient's primary podiatrist during the first year (year B pathway). After the first year,     patients will switch to the opposite year pathway for the next 12 months. Participation in     this study will last approximately 24-26 months.   "
113766|NCT01796795|"     This phase II study is to evaluate the efficacy of SR-T100 gel in complete clearance of     target warts at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant     extract) in patients with CW.   "
113767|NCT01796782|"     Primary End Point:      - To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in     patients with metastatic pancreatic cancer.      Secondary End Points:        -  Compare clinical efficacy by other measures including PFS,tumor response,and changes in          quality of life (QOL) between these two groups.        -  Examine the feasibility and assess the side effects of treatment using QYHJ Granules in          patients with metastatic pancreatic cancer.   "
113768|NCT01796769|"     Targeted population:      Sleep apnea patients at low cardiovascular risk newly treated by CPAP      Hypothesis:      Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP     care.      Main goal:      To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are     randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based     on a telemonitoring web platform.   "
113769|NCT01796756|"     Miscommunication during patient handover can jeopardize patient safety and is the focus of     Quality Improvement initiatives by many organizations. It is widely recognized that such     miscommunication is preventable using a number of strategies identified in the literature.      Currently, there is no formal handover process of General Internal Medicine in-patients,     otherwise known as the Clinical Teaching Unit (CTU) at Vancouver General Hospital, which is a     major patient safety concern. This project will implement a formal handover program and     evaluate whether there are changes in resident satisfaction with handover, but more     importantly, whether the investigators can improve patient outcomes.   "
113770|NCT01796743|"     A novel Cardiac MRI sequence, developed by Dr. Maria Altbach (Double Inversion radial fast     Spin Echo T2 mapping), has been tested clinically. It demonstrated a high sensitivity to the     heart muscle swelling (edema) in different types of heart injury, including heart attacks.      The investigators propose to use T2-Map methodology in patients with acute heart attacks and     to compare value of this method with other clinical and imaging parameters in predicting     short-term (30 day) clinical outcomes of these patients.      If successful, the project will provide an effective risk-stratification tool to identify     patients with heart attack as a result of atherosclerotic disease, who require more     aggressive therapeutic approach and closer follow-up after initial hospitalization.   "
113771|NCT01796730|"     This is a randomized, double-blind, 3-crossover trial with a 7-days washout baseline period     followed by three treatment periods of 21-days each performed in patients with COPD. Patients     will be randomized to receive three treatments (bambuterol 10mg, bambuterol 5 mg and     placebo).   "
113772|NCT01796717|"     1. To observe clinical and bacteriologic responses of different regimens of          piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of          nosocomial pneumonia.        2. To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged          or intermittent infusion) in patients with nosocomial pneumonia.        3. To assess the safety profiles of piperacillin/tazobactam 4.5g q6h, prolonged or          intermittent infusion in patients with nosocomial pneumonia.   "
113773|NCT01796704|"     The study hypothesizes that an assumed cardiovascular performance reserve is physiologically     detectable.      High reserve at rest characterizes a healthy person while low reserve at rest characterizes     low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.      The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by     an algorithm composed of physiological measurements taken during the patient visit.      In this study the investigators evaluate CVRI capability in prediction of functional capacity     in comparison with the clinical evaluation during the same visit.   "
113774|NCT01796691|"     Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.   "
113775|NCT01796678|"     Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD).     Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of     emergency department visits. Currently efforts to treat painful episodes with use of     non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without     targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an     arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since     arginine is the obligate substrate for NO production, and an acute deficiency is associated     with VOE, investigators hypothesized that arginine supplementation may be a safe and     beneficial treatment for sickle cell pain.   "
113776|NCT01796665|"     The objective of this study was to evaluate the efficacy and safety of Perrigo's test     formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to     the already marketed formulation, Acanya gel in patients with acne vulgaris.   "
113777|NCT01796652|"     Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied     the feasibility of home management in AP.The aim of study was to compare 30 day readmission     rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home     monitoring versus hospitalization.   "
113778|NCT01796639|"     The primary objective of this study is to evaluate graft survival and recipient survival     among kidney transplant recipients in China, and also to analyze possible factors related to     patient and graft survival.      The secondary objective is to evaluate several secondary outcomes among kidney transplant     recipients, such as average creatinine value, acute rejection episodes, NODM, incidence of     BKV infection etc. At the same time analyze possible impact factors related to these     secondary outcomes.   "
113779|NCT01796626|"     At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2     clinical sites; each clinic will enroll at least 15 subjects.      Subjects should present visible wrinkles and/or striae requiring treatment.      Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at     least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least     50% using VAS as compared to baseline, for at least 75% of the subjects.   "
113780|NCT01796613|"     The study is a multidisciplinary research project and has two main aims:        1. To determine the safety of a contraceptive vaginal ring (CVR) in women, with an emphasis          on its effect on the vaginal microenvironment after different durations of use: the          vaginal microbiome, biofilm formation on epithelial cells and rings, inflammation and          immune activation in the vagina        2. To investigate the feasibility, acceptability and adherence to vaginal ring use in          Rwandan women, including attitudes towards a future multi-purpose vaginal ring for          prevention of both pregnancy and sexually transmitted infections (STI).   "
113781|NCT01796600|"     ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging.     Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for     an analysis of the distal appendicular skeleton. The investigators' hypothesis is that the     cone-beam scanner could detect and characterize fractures of the extremities similarly to a     multidetector CT (MDCT). 150 patients over 18 years requiring a CT scan for a suspected     distal limb fracture or a preoperative assessment will be enrolled. The primary endpointis     based on the ability of cone-beam scanner to properly characterize the type of fracture using     a classification derived from Maurice E. Müller (AO) classification. Secondary endpoints will     concern the depiction of the fracture, the assessment of the soft tissues near the fracture,     quality of images, inter and intra-operator reproducibility and tolerance of the patient for     the examination. Patients will have a MDCT considered as the reference exam, then a CBCT.     Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals.     The inter-observer agreement for the diagnosis of fracture type between the two techniques     will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be     achieved by studying the sensitivity, specificity, negative predictive value and positive     predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the     consistency of the characterization of the fracture and the evaluation of soft tissue near     the fracture. A Student t test will be performed for paired data if distributions are normal,     a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not     painful) will be calculated for each technique and will be compared using the Chi2 test (or     Fisher's exact test if the chi can not apply).   "
113782|NCT01796587|"     Primary objective: To evaluate compliance of LoFric Origo in a general intermittent     catheterization (IC) population with the use of LoFric Origo, by means of a subjective     assessment scale      Secondary objectives:        -  To evaluate the subject's perception associated with the use of the LoFric Origo, by          means of a subjective assessment scale        -  To evaluate the subject's discomfort associated with the use of the LoFric Origo, by          means of a subjective assessment scale        -  To observe and collect data on bladder regimen/IC frequency by assessments of          descriptive data of demography, catheter therapy, history and other patient reported          outcomes.      Study Design: Non-interventional study, multicentre, prospective study. Target Subject     Population: General intermittent catheterization, LoFric Origo male users.      Medical Device: LoFric Origo      Study Variable(s):        -  Primary variable: Use or No use of LoFric Origo after 8 weeks.        -  Secondary variable(s): patient reported questionnaire with regards to perception,          discomfort, diagnose, health status, catheter history and other patient reported          outcomes.   "
113783|NCT01796574|"     This research is being done to observe the safety, tolerability, side effects, and     effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus)     being treated in a neurointensive care unit.   "
113923|NCT01794728|"     The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity     to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson     University Hospital (TJUH). Additional information on their existing co-morbid conditions, an     inventory of their prescribed medications, and details regarding the type of treatment     interventions (over the counter analgesia and other comfort practices) they report using will     be collected.   "
113784|NCT01796561|"     Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all     deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation     2008 figures), a well established modifiable risk factor for CVD. Above 115/75 mmHg, CVD risk     doubles for each increment of 20/10 mmHg that blood pressure is raised. An increase in BMI     and waist circumference has been associated with an increase in blood pressure. The leaves of     the olive plant are rich in plant compounds known as polyphenols. This particular group of     polyphenols are known secoiridoids, which are also present in olive oil and olives though at     lower concentrations, are only found in this family of plants. Diets high in polyphenols have     been found to reduce the risk of chronic diseases. Studies have shown that consumption of     phenolic-rich olive leaf extract (OLE) can significantly reduce blood pressure in individuals     suffering from high blood pressure (hypertension), with the magnitude of effect being     comparable to a commonly used antihypertensive drug. In such trials OLE also resulted in an     improved blood lipid (a reduction in total and LDL cholesterol and triacylglycerides) which     also reduces CVD risk. One study testing the effect of OLE on individuals with mild or     prehypertension (i.e. those with systolic blood pressure in the range 121-139 mmHg and     diastolic blood pressure in the range 81-89 mmHg but not taking antihypertensive medication)     also found these same improvements. OLE has been indicated to have the potential to improve     other cardiovascular risk markers such as vascular function, inflammation, platelet     aggregation, oxidation of LDL and glucose tolerance however much of this evidence is derived     from animal, in vitro and ex vivo studies and so well designed and controlled human studies     are required to verify that these findings are applicable to humans. Therefore OLE     supplementation may be a useful dietary strategy for reducing CVD risk in a cohort of     overweight prehypertensive individuals.      The aim of the study is to determine the effect of OLE intake on blood pressure and other CVD     risk markers in overweight subjects with mild hypertension and to link any study outcomes     with the presence of OLE phenolics in urine   "
113785|NCT01796548|"     The purpose of this study is to evaluate the effects and tolerability (how well a participant     can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release     (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with     neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work     properly leading to frequent feeling of need to urinate during the day, night, or both).   "
113786|NCT01796535|"     This is a multi-center, non-randomized post marketing surveillance registry including up to     125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation     at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an     Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should     be per standard of care.   "
113787|NCT01796522|"     Hypothesis: Both nifedipine or progesterone are widely used in clinical practice as     maintenance tocolytic therapy after an episode of threatened preterm delivery. Nevertheless,     there is insufficient evidence to justify its routine use. The present study aims to evaluate     the efficacy and safety of these tocolytic drugs for maintenance tocolysis in the management     of threatened preterm delivery.      Materials and methods:      Phase III clinical trial, which evaluates the efficacy and safety of nifedipine and     progesterone as maintenance tocolytic therapy until the 34th week of pregnancy in randomized     women after an episode of threatened preterm delivery.      Pregnant women with singleton pregnancies are going to be evaluated, with intact membranes     and cervical length less than or equal to 25 mm, which have received acute tocolysis with     atosiban. They will be randomized to receive maintenance tocolysis with nifedipine (60 mg /     day orally) or progesterone (200 mg / day vaginally) until week 34 of gestation. Therefore     all included patients will receive treatment with proven but not agreed efficacy, to decrease     the recurrence of threatened preterm delivery, prolongation of gestation and subsequent     better perinatal outcome. During the course of pregnancy, patients will be monitored in     outpatient obstetrics, thus checking an adequate compliance. Monitoring will continue until     the end with the delivery and collection of newborn data.      The study will be single-blind, since there will be a blind evaluator. The drugs or     treatments not allowed before and / or during the clinical trial are those which are     indicated in the data sheet for each drug. If the patient takes antihypertensive treatment     and continues it during pregnancy, dose adjustment will be done if it is needed.      Data will be collected in the case report data (CRD). The end of the test will be considered     when the last recruited patient complete the gestation (delivered vaginally or cesarean), and     all data from newborn are collected. If a serious adverse event occurs in a patient, the     woman will immediately finish the clinical trial and will be followed until complete     resolution of the episode.      Treatment is going to be considered effective if the birth occurs after 37 weeks of pregnancy     with satisfactory perinatal outcome. The drugs are going to be considered safe if they do not     cause adverse events in pregnant women, or if they are not serious.      Number of Subjects: 50 pregnant women      Diagnosis and main criteria for inclusion and exclusion:      Inclusion Criteria        -  Pregnant women with singleton pregnancies and intact membranes which have passed an          episode of threatened preterm delivery (uterine contractions with cervical change)          successfully treated with atosiban as acute tocolytic therapy.        -  Cervical length ≤ 25 mm. Exclusion Criteria        -  ≥ 3 cm cervical dilation, multiple pregnancy, maternal medical contraindication to          tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to          tocolytic treatment (severe preeclampsia, intrauterine infection, placental abruption,          fetal abnormality incompatible with life, fetal death) .      Investigational product, dose and mode of administration: After a successful treatment of     acute preterm labor with atosiban, is will be compared the safety and efficacy of maintenance     tocolytic therapy with nifedipine 60 mg / day orally or progesterone 200 mg / day vaginally.      Therapeutic group: C08CA05 Nifedipine. G03DA04 micronized progesterone.      Route of administration: nifedipine orally. Progesterone vaginally.      Dose: Nifedipine 60 mg / day. Progesterone 200 mg / day.      Duration of treatment: From the resolution of acute episode of threatened preterm labor until     34 weeks of gestation.      Reference treatment, dose and mode of administration: Current evidence questions the utility     of maintenance tocolytic therapy. No reference treatment is currently defined.   "
113788|NCT01796509|"     Study Hypothesis:      Critical illness is associated with long-term medical and psychological sequelae that can     impact the professional and private life. The purpose of the present multicenter randomized     controlled trial is to assess whether or not a medical, psychological and social follow-up     improves quality of life of critically ill patients at one year after their discharge from     intensive care unit (ICU).      Primary Purpose:      Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one     year after ICU discharge.   "
113789|NCT01796496|"     The purpose of this study is to analyze the effectiveness of a three manipulative therapy     techniques in People with Chronic Low Back Pain.   "
113790|NCT01796483|"     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor     functions in patients with Parkinson disease (PD). However, growing evidence suggests that     STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al     2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007;     Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are     still unclear. Two reasons might explain this. 1) From a theoretical point of view, cognitive     models of executive control mechanisms are incomplete. 2) From a methodological point of     view, investigating cerebral activity during STN-DBS is very limited because most techniques     are incompatible with locally implanted electrodes.      This project relies on a double opportunity to answer these questions offered by recent     theoretical and methodological advances. First, investigations in healthy subjects (Jaffard     et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory     control, so far ignored, consisting in locking in advance movement triggering processes to     prevent undesired automatic or anticipated responses to unattended stimuli. In other words,     key processes of executive control may act tonically before stimulation occurs, calling brain     imaging studies to look at proactive and not only reactive activations. Second, recent     advances in EEG signal processing now allow suppressing from the electroencephalogram     DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a     non-invasive technique with the high temporal resolution necessary to disentangle proactive     from reactive brain activity. To our knowledge, up to date no study has been published using     EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this     project is to identify the anatomo-functional origin of STN-DBS-induced executive dysfunction     using EEG recordings in classical stimulus-response tasks. Results expected from this first     part of the project may help resolving other long-lasting issues. Indeed, reactivity as     assessed by simple reaction time in non-implanted patients as well as impulsivity in STN-DBS     patients are known to remain insensitive to dopaminergic medication. Since the proactive     activity related to executive, inhibitory, control may be supported by the noradrenergic (NA)     system, the second purpose of this project is to test the original hypothesis according to     which NA plays a central role in both akinesia and STN-DBS side effects.   "
113791|NCT01796470|"     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of     entospletinib and idelalisib. Participants will be enrolled who have one of the following     hematological tumor types: chronic lymphocytic leukemia (CLL), follicular lymphoma (FL),     mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or non-FL indolent     non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/Waldenström     macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma     [MZL]).   "
113792|NCT01796457|"     This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of     Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis     B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive     Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199).      This study will examine the balance between immune regulatory and effector responses in     hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and     NCT01369199) to define natural history and treatment outcome.   "
113793|NCT01796444|"     The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel     lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic     therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary lymph node     dissection (ALND) did not result in inferior survival. These patients, therefore, are     unlikely to benefit from further surgery that results in a longer period of hospitalization,     higher costs and higher postoperative morbidity. This result has been written in the 2012     National Comprehensive Cancer Network Clinical Practice Guidelines.      However, Limitations of Z0011, such as failure to achieve target accrual and possible     randomization imbalance favoring the SLNB-alone group, must be considered. In the other hand,     further testing in different country are needed.      The investigators design and begin a prospective randomized multicenter phase III study of     ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.   "
113794|NCT01796431|"     The purpose of the study is to look at the levels of three HIV medications: tenofovir,     emtricitabine, and rilpivirine in blood after the drug intake has been stopped in order to     understand how long these drugs persist in the blood. The study will specifically look at     blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for     14 days.      The duration of the subjects involvement in the study will be up to 23 days plus a screening     visit which will take place up to 4 weeks prior to the start of the study, and a follow up     visit which takes place 16-22 days after the last dose of study medication.      This study is not randomised which means that all participants will receive all study     medications in the same order. The participant and the study doctor will know which study     medications you are taking at all times during the study.   "
113795|NCT01796418|"     Diabetic nephropathy, the leading cause of end-stage renal disease in many countries, is     characterized by high cardiovascular mortality and morbidity even in the early course of the     disease. In addition, cardiovascular complication has been the most common cause of death in     these patients. Thus, early detection and appropriate intervention for this highly common and     critical complication is considered to play an important role in the management of the     disease. In this regard, much interest has been focused on the early markers which can     predict arterial diseases before the clinically apparent cardiovascular diseases. Recently,     glowing evidence suggests that arterial stiffness as assessed by pulse wave velocity (PWV)     may serve as a surrogate marker for future cardiovascular disease. In fact, increased PWV has     been known to be independently associated with diabetic nephropathy in type 2 diabetes.      Beraprost sodium (BPS) is a stable orally active prostacyclin (PGI2) analogue that has a     potent vasodilatory and anti-platelet effect. Also, BPS has been suggested to improve a     micro-vascular circulation through a reduction of red blood cell deformability. In addition,     recent studies have demonstrated that BPS improves endothelial function through an increase     in endothelial nitric oxide synthesis and NO synthase gene transcription. These beneficial     effects of BPS have been known to reduce PWV in patients prone to cardiovascular diseases     such as elderly, hypertension, or a history of cerebral infarction. However, the effect of     BPS on arterial stiffness in patients with diabetic nephropathy remains elusive. Our study     will address the effect of BPS on arterial stiffness by PWV in patients with diabetic     nephropathy.   "
113796|NCT01796405|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug to learn whether the drug works in treating a     specific disease. Investigational means that the drug is still being studied and that     research doctors are trying to find out more about it-such as the safest dose to use, the     side effects it may cause, and if the drug is effective for treating different diseases. It     also means that the FDA has not yet approved clofarabine for your disease.      Clofarabine is a chemotherapy drug that has been used in the treatment of leukemia in     children and adults. Information from other research studies suggests that this drug may also     be effective in patients with LCH.      The purpose of this study is to estimate the response rates of participants with recurrent     LCH to clofarabine within each of two strata: a) low-risk participants with disease     reactivation, and b) high-risk participants with risk-organ involvement.      Other purposes are to estimate the progression-free survival after clofarabine treatment,     estimate survival of participants with refractory multi-system LCH with risk organ     involvement treated with clofarabine and to describe toxicities of clofarabine in     participants with LCH.   "
113797|NCT01796392|"     The purpose of this research is to study an investigational medical device that is designed     to produce lung volume reduction in diseased areas of the lungs in patients with severe     emphysema.   "
113798|NCT01796379|"     Compared to end-stage heart failure, a patient's situation is usually greatly improved after     a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term,     ranging from 50 to 70% in most studies. While effective rehabilitation, including regular     exercise, is considered an effective tool of improving health related quality of life (HRQoL)     and prognosis of cardiac patients in general, the knowledge about and the effect of different     rehabilitation programs among HTx recipients is limited. Exercise training is considered one     of the most central parts in rehabilitation, but the mode of exercise used in different     studies varies considerably. It is documented that high intensity interval training (HIT) has     superior effects compared to training with moderate intensity in cardiac and heart failure     patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered     unphysiological. However, the investigators have recently demonstrated highly beneficial     effects on exercise capacity, muscle strength, body composition, reduced progression of     cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study     the investigators want to test the hypothesis that systematic aerobic exercise with high     intensity improve exercise capacity also in newly transplanted recipients, and secondarily     that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.   "
113799|NCT01796366|"     This trial is conducted in Europe. The aim of the trial is to investigate the safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338     (insulin 338) in subjects with type 2 diabetes.   "
113800|NCT01796353|"     The objective is to investigate the effect of a comprehensive sexual rehabilitation program,     consisting of a psycho-educative component and a physical exercise component.      The primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual     function.   "
113801|NCT01796340|"     The primary objective of the study is to investigate the effectiveness of two intensive     two-session trainings, the conventional psycho-education and food cue exposure, on eating in     the absence of hunger, binge eating and Body Mass Index (BMI) change in overweight/ obese     children.   "
113802|NCT01796327|"     This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is     taken up from the digestive tract into the body when given as an oral tablet compared with     that taken up by an intravenous dose.   "
113803|NCT01796314|"     Therapeutic education expands in Alzheimer's Disease management in France. Several studies     revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this     study, is to determine whether a therapeutic educational programme for both AD patients and     primary caregivers, in community dwelling, improves patient's quality of life.   "
113805|NCT01796288|"     This was a multi-center randomized controlled Phase II clinical trial. Patients with     oligometastatic stage IV (number of distant metastases ≤ 5) non-squamous non-small cell lung     cancer treated with second-line erlotinib150mg daily for 3 months with clinical benefits     (free-from progression) were randomized (stratified according to smoking status and different     research centers) to the radiotherapy group (n = 100) and the non-radiotherapy group (n =     100). Radiotherapy group (experimental group) patients started simultaneously radiotherapy     for all gross tumors soon after randomization; non-radiotherapy group (control group)     received no radiotherapy for all gross tumors. Erlotinib was continuously used until to     disease progression or unbearable adverse effect, and the subsequently further salvage     therapies were determined by the investigators. The primary endpoint was PFS.   "
113806|NCT01796275|"     The School of Public Health of HKU collaborates with the Hong Kong Council of Social Service     (HKSCC) to conduct a district-based mega-project Happy Family Kitchen, which using eating     and the kitchen as a platform, to make the effort to improve effective communication in     Hong Kong families.      The HFK 2 project is a enhanced version of HFK project, which plan to be conducted in the     Tsuen Wan, Kwai Chung and Tsing Yi district from August 2012 to August 2013. This project     adopts a cluster-randomized controlled design, with the application of positive psychology     concepts as a theoretical framework. A community-based participatory (CBP) approach, which is     an effective way to engage public health researchers and community members (NGOs, schools,     other major stakeholders, and participants), will be used. Both quantitative and qualitative     methods will be used in the evaluation of major outcomes (participants' family relationship     and 3Hs) at different time points throughout the project. Process evaluation will be     performed to evaluate the process of each component of the project. The whole project     includes two phases:      Phase 1: Model enhancement- an enhanced model of project is started with the training the     trainer workshop to build capacity among the community partners. After that, the trained     community partners design and conduct the district-based intervention programmes by using one     of the five themes of the positive psychology framework, which teach the participants to     practice positive behaviors for improving family communication, and in turn promote the 3Hs.     The five themes are joy, flow, gratitude, savoring and listening. The pre-, post-, 4 weeks     and 3 month follow up questionnaire surveys are conducted to assess the effectiveness of the     programmes. All of the participating NGOs and schools will be randomly allocated into three     groups:      Intervention arm 1: core session intervention + booster intervention; Intervention arm 2:     only core session intervention; Control arm: waiting list control, only questionnaire     evaluations can be conducted at different time points.      A subsequent qualitative study is conducted to further explore the outcomes, the problems and     the requirements from the programmes.      Phase 2: Model scaling up- A series of Professional Tool Kits consist of practice guides and     evaluation tools for different service settings will be published with the contribution of     participating NGOs and project partners. The tool kits will be the key reference and be     further disseminated to a wider scope. A series of Professional Practice Seminars will be     organized in different regions (including Hong Kong, Kowloon and New Territories). Social     work practitioners of various service settings will be invited to attend the seminars. The     evidence-based professional tool kits will be introduced and distributed in the seminar.     Clinical psychologist will be the speaker on how to apply positive psychology in practice,     and HKU staff will also illustrate the use of evaluation tools in assessing the outcome of     the program. Participating NGOs of this project will be invited to share their practice     experience in Tsuen Wan and Kwai Tsing district as well. another new edition of Happy Family     Cookbook will be published and distributed to the whole territory. The new edition will be     enhanced with more attractive content including healthy recipes and tips for positive     communication etc. To enhance the interactivity of the cookbook, related apps for mobile     devices will be developed for public free download.   "
113807|NCT01796262|"     The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in     reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample     of children and adolescents with ADHD.   "
113808|NCT01796249|"     The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI)     measured at the end of surgery for the prediction of immediate postoperative pain in     postoperative care unit in adult patients undergoing general anesthesia.   "
113809|NCT01796236|"     To demonstrate that the minimally invasive surgical procedure in combination with the use of     the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection,     overgrowth, pain and numbness at the site of implantation compared to the traditional     surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha     BA300 Abutment).      To demonstrate that the minimally invasive surgical procedure in combination with the use of     the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due     to shorter surgical procedures, faster wound healing and less complications compared to the     traditional surgical procedure in combination with the use of the standard Baha abutment     (Cochlear Baha BA300 Abutment).   "
113810|NCT01796223|"     The aim of this study is to evaluate the effects of a feedback-system in psychotherapy on     adult out-patients at a community mental health centre. It is hypothesized that the     intervention will lead to more effective treatment, decreasing treatment dropout as well as     improving patient-therapist relationship and patient activation in treatment.   "
113811|NCT01796210|"     The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the     prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on     general anesthesia.   "
113812|NCT01796197|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer. In     this study, paclitaxel and trastuzumab are being combined with pertuzumab which is     investigational for the preoperative treatment of inflammatory breast cancer. Trastuzumab     is given for a total of 12 months for the treatment of HER2 positive breast cancer. This     study also adds pertuzumab to trastuzumab so that both drugs are given for a total of 12     months; this combination is also investigational.      Investigational means that pertuzumab is being studied. It also means that although the FDA     has approved pertuzumab for preoperative use to treat breast cancer, it has not been     thoroughly studied in combination with paclitaxel and trastuzumab for preoperative treatment     of inflammatory breast cancer. It has been FDA approved for specific use in advanced breast     cancer that is HER2 positive.      Pertuzumab is an antibody, which is a protein that attacks a foreign substance is the body.     Pertuzumab blocks the function of the HER2 protein like trastuzumab does. However, pertuzumab     binds to a different part of the HER2 receptor and stops cancer cells from growing. This drug     has been used in the treatment of advanced breast cancer that is HER2 positive, and has been     combined with trastuzumab and chemotherapy in those studies. Information from those other     research studies suggests that pertuzumab may help to kill the cancer cells in the breast and     enable you to undergo a mastectomy. The addition of pertuzumab may also help reduce the     chance of cancer recurrence.      In this research study, we are combining pertuzumab with paclitaxel and trastuzumab as     preoperative therapy and will determine the response of the cancer remaining in the breast at     the time of mastectomy. In addition, we are combining trastuzumab with pertuzumab for a total     of 12 months and we are looking to see whether the combination reduces the chance that the     cancer will return.      Another goal of this research study is to determine whether we can develop a way to identify     tumors that will respond well to this study treatment. We will do research tests on your     tumor tissue before, during and after study treatment. These tests may help doctors     understand how the study treatment may work to treat your type of breast cancer. In the     future, these tests may help us find ways to help match patients with the drugs most likely     to work against their specific tumors before treatment begins.   "
113813|NCT01796184|"     Background. Obesity, insulin resistance and type 2 diabetes are closely associated with     chronic inflammation characterized by abnormal cytokine production. Some authors have found     discordances between glycated hemoglobin (HbA1c) and other measures of glycemic control,     suggesting that a glycation gap, defined as the difference between the HbA1c concentration     and that predicted by the fructosamine concentration, could explain the excess     interindividual variation in HbA1c.      The present study was aimed to examine the association between inflammation, sociodemographic     (age, gender) and lifestyle factors (diet, exercise, alcohol, and tobacco consumption), and     common diseases. In addition, we also examine levels of blood glucose, HbA1c, fructosamine     and glycation gap determining the prevalence of high glycators in a general adult     population and their association with lifestyles and prevalent diseases.      Methods. Selection of a random sample of the general adult population from a single     municipality (A-Estrada, Pontevedra, Spain), stratified by age. The initial sampling includes     3,500 subjects. Considering approximate 67% participation rate, the final study population     would include more than 2,000 individuals. The standard workup includes structured     questionnaires, skin prick test, periodontal examination, psychological tests, physical     examination and blood determinations to allow for categorization of participants in terms of     basic demographics, profession, education level, socioeconomic level, quality of life,     physical activity, diet, alcohol consumption and smoking, atopy, obesity, diabetes, metabolic     syndrome, hypertension, cardiovascular disease, and liver disease. We determine blood levels     of inflammation markers, HBA1c, fructosamine and glucose. We will collect a urine sample for     microalbuminuria determination. In addition, blood will be drawn to be stored at the Biobank     of our Hospital. One half of participants (~1000 individuals) will undergo continuous glucose     monitoring. The design is cross-sectional, followed by a longitudinal study using population     registries for the determination of events (mortality).      Discussion. This comprehensive study in a general adult population provides an excellent     opportunity to determine serum concentrations of inflammation and glycation markers and how     they can vary widely with age, sex, common habits, metabolic abnormalities, and chronic     diseases. The findings from this study should also help to find out the relationship between     glucose profiles and HbA1c and fructosamine concentrations with diet and inflammation     markers.      Keywords: Inflammation, glycation, glycated hemoglobin, glycation gap, continuous glucose     monitoring, obesity, allergy, periodontal diseases, depression, metabolic diseases.   "
113814|NCT01796171|"     This study is a phase I/II, open-label study in patients with relapsed positive non-Hodgkin     lymphoma. The Phase I part of the study is a dose escalating study to define the maximum     tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics,     biodistribution and efficacy. After completion of the phase I study, a dose will be selected     for the phase II part of the study which is designed to investigate tumour response rate,     progression free survival, confirmation of the selected dose as well as safety and toxicity.   "
113815|NCT01796158|"     The goal of this project is to conduct a pilot study evaluating feasibility, acceptability,     and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET)     intervention for alcohol-involved adolescent primary care patients.   "
113816|NCT01796145|"     In patients with inoperable HCC undergoing non-surgical therapy as first-line therapy        1. We aim to determine the prognostic significance of liver stiffness in patients with HCC        2. We aim to determine the rate and severity of complications of treatment and its          association with liver stiffness in patients with HCC   "
113817|NCT01796132|"     Background: The childbearing years are a time of increased vulnerability to the onset of mood     disorders in women and a high prevalence of exposure to antidepressant drugs during pregnancy     and postpartum has been reported. However, the lack of information regarding the milk     transfer and the safety of these drugs in breastfed infants and the related fear of adverse     events for the sucking infant are some of the factors responsible for stopping prematurely     breast-feeding or avoiding drug therapy. Selective serotonin reuptake inhibitors (SSRI) and     selective serotonin and noradrenaline reuptake inhibitors (SNRI) are the most frequently     prescribed antidepressant drugs during pregnancy and the post-partum period. They exhibit a     wide interpatient variability in their concentration profiles that has been related to     numerous environmental, stereochemical, demographic and genetic influences that might alter     the level of exposure of breastfed newborns. Limited information is available regarding the     safety of use of these antidepressant drugs during lactation, and is generally derived from     small studies. A comprehensive description of their distribution and quantification in milk     in a larger cohort of patients under various influences and the resulting impact on milk     concentrations is lacking.      Objectives: The current proposal addresses the primary objectives of quantifying the range of     concentration to citalopram, escitalopram, sertraline, fluoxetine, paroxetine, fluvoxamine,     duloxetine and venlafaxine in mother plasma and breast milk in relation to genetic     polymorphisms, stereochemistry, demographics and environmental factors in a large cohort of     depressive mothers. This will enable to derive the exposure to the breast-fed child taking     into account this variability and therefore better adjust treatment to potential influences.     As secondary objectives, we will examine the neurodevelopmental outcome of a sub-set of     infants subjected to SSRI/SNRI in utero and/or during breastfeeding at birth, 6, 18 and 36     months, and compared to that of a control population of infants not subjected to this     treatment.      Expected Results: The proposed strategy will offer new information regarding the expected     level of drug exposure associated with each or with a combination of risk factors and help     for optimizing the security and rationalizing the use of antidepressant treatment in     lactating women. Hence, research on the safety of use of these drugs for the developing child     is an area of great public health significance.   "
113818|NCT01796119|"     In this split-mouth controlled study, implants placed using the alveolar ridge expansion     technique will be compared to those placed in native bone with sufficient horizontal bone     width.      The Piezosurgery device and Bone expanders (Mectron,Italy) will be employed in an alveolar     ridge expansion technique.   "
113819|NCT01796106|"     The goal of the project is to investigate the clinical efficacy of management of early caries     lesions by resin infiltration, which may be imaged through a SFE laser optical device     comparable to radiographic results.   "
113820|NCT01796093|"     This is an investigator-started study. The trial is coded as no. GC&PJ-Dig-Iva2009-2012.      The authors have no conflict of interest and there was no financial sponsoring The study was     planned according to the Good Clinical Quality standards using an intention-to-treat     analysis. The protocol was approved from the ethics committee. Selected patients gave their     written informed consent. The family practitioners agreed and obtained the collected data and     analysis. Analysis of collected data was performed by a single-blinded author (without     knowledge of the used test drug and time of collection of data).      Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with     permanent atrial fibrillation (ischemic etiology).      Multiple Time Frames: Primary Outcome is measured before and after each medical intervention.      Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):      Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and     during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection     rate, left trial size,diastolic function.      Participants were followed (ambulatory observation) for at least 3 months   "
113821|NCT01796080|"     In this randomised controlled cross-over study we will investigate whether intrathoracic     pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature     supraventricular and ventricular contractions as well as atrial fibrillation in patients with     paroxysmal atrial fibrillation.   "
113822|NCT01796067|"     The increasing rate of obesity has become a major public health concern with national reports     indicating 40% of African American adolescents are now overweight/obese. Little is known     about effective weight loss interventions in ethnic minority adolescents. However, research     has shown that ethnic minorities attend fewer intervention sessions, have higher attrition     rates and lose less weight compared to Caucasians. Two fundamental problems related to this     lack of progress are 1) lack of appropriate content of weight loss interventions for African     American adolescents that integrate cultural issues, parenting skills, and motivational     strategies for long-term change and, 2) poor dose of weight loss interventions because of     participant fatigue and drop out. While previous weight loss studies for adolescents have     been long lasting (12-25 weeks), our team developed a weight loss program that is a     relatively brief (8-week) face-to-face intervention that integrates motivational     (autonomy-support) and positive parenting skills (monitoring, social support, positive     communication skills) for reducing z-BMI in overweight African American adolescents. Our team     recently conducted a pilot study testing the feasibility of an 8-week on-line culturally     tailored intervention, Thus, the goal of this project is to conduct a randomized controlled     efficacy trial to address the problems with past studies by 1) making the face-to-face group     intervention shorter, 2) using an on-line component to compliment the group-based     intervention for increasing dose, and by 3) tailoring a motivational and parenting skills     program directly to parents and adolescents skill levels and cultural background. 520     overweight African American adolescents and their parents will be recruited to participate.     Phase I of the trial will test the efficacy of an 8-week face-to-face group randomized trial     comparing motivational plus family-based weight loss (M+FWL) to a basic health (BH) education     program on reducing z-BMI and improving diet and physical activity (PA) in overweight African     American adolescents. In phase II of the trial participants will be re-randomized to either     an 8-week on-line intervention or a control on-line program resulting in a 2 (M+FWL vs. BH     group) x 2 (intervention vs. control on-line program) factorial design. A 6-month follow-up     will examine whether adolescents in the 8-week M+FWL group plus 8-week on-line intervention     program will show the greatest maintenance in reducing z-BMI.   "
113823|NCT01796054|"     Mindful meditation sessions have been associated with an improvement in mindfulness,     perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation     has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen     consumption and energy expenditure. Randomized controlled trials of online mindfulness and     relaxation programs have been studied in patients with conditions such as irritable bowel     syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such     programs given levels of job stress. This study will determine whether an online stress     reduction program that incorporates meditation with and without concomitant group support     reduces burnout among nurses, including emotional exhaustion and depersonalization. The     proposed research study will utilize Stress Free Now, an online stress reduction program     developed by Cleveland Clinic Wellness Institute.   "
113824|NCT01796041|"     According to the World Health Organization, breast cancer is the most common cancer in women,     and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000     women perished from the disease in 2002. Surgery remains the best option for patients     presenting with operable Stage I, II or III cancers. Breast conservation surgery has been     shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast     cancer are breast conservation candidates. However, the need to achieve negative tumor     margins often requires a second operation (re-excision) in up to 70% of the women having     lumpectomy surgery. Currently, tumor margins assessment in the operating room is often     assessed grossly by palpation. The ability to evaluate tumor margin using our proposed     intraoperative imaging technique may provide the surgeon with an alternative, and hopefully,     more sensitive method to assess tumor margins which may decrease re-excision and the     morbidity associated with additional surgery, and, perhaps, lower the risk of local regional     recurrence.   "
113825|NCT01796028|"     Prostate cancer is the second leading cause of mortality in men, representing 10 deaths about     of 100 cancers (INVS 2009). Treatment for metastatic prostate cancer, when becoming resistant     to hormone-treatment, is mostly resumed to a relatively ineffective chemotherapy     (Docetaxel/TAXOTERE®) (1). Recently, numerous clinical and preclinical works showed that     Metformin could represent an excellent candidate for treatment of advanced prostate cancer.     This is a widely prescribed drug, for type 2 diabetes, with clinical advantage of exhibiting     very rare serious side effects. On the other hand, the use of this molecule in patients was     associated with a decrease of tumors incidence, in particular prostate cancer (2). Numerous     in vitro and in vivo studies support its role as an anti-cancer drug, in several cell lines     (3). These experimental results are consistent with a clinical trial pilot study, performed     in colorectal cancer, showing anti proliferative effect of Metformin (4). In the field of     prostate, F. Bost in J.F. Tanti's team (INSERM U895, Nice) demonstrated that Metformin     inhibits cell viability of human prostate cancer cells, via mTOR downregulation and decrease     tumor growth in a xenograft model (5). Furthermore, preclinical data performed by this team     showed that Metformin increased significantly apoptosis induced by TAXOTERE®. Therefore, by     targeting specifically cancer cell metabolism, Metformin offers new promising therapeutic     strategy.      The primary objective of this randomized study is to evaluate the biological efficacy of     Metformin combination with TAXOTERE® in patients with metastatic hormone-refractory prostate     cancer. To achieve this purpose, PSA response rate will be evaluated according to ASTRO     definitions (Bubley, Carducci et al. 1999). Concurrently, secondary endpoints will be under     investigation in order to evaluate the clinical response according to RECIST criteria, the     overall and free-progression survival and the quality of life. Toxicity assessment will also     be performed regarding to this drug combination.      Considering the well tolerability of Metformin and the first clinical and pre-clinical data     reports of it use in cancer treatment, combining Docetaxel (TAXOTERE®) with Metformin may     represent a promising strategy for treatment of hormone-refractory prostate cancer.   "
113826|NCT01796015|"     Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury     (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also a     risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP)     monitoring is likely to guide therapeutics, and certain research on adults or on children,     suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve     the prognosis. Two monitoring techniques are currently recommended. They are reference     methods for ICP measure :        -  monitoring with intraventricular catheter,        -  intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have          been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD)          which is the most interesting one. The ONSD measured ultrasonically is correlated with          ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the          first 24 hours. In children, ONSD average values have been worked out, and an ONSD          increase is found in children suffering from hydrocephalus with IH and in children with          TBI. ICH precocious detection is fundamental in children sensitive to ICH because their          cerebral development is not finished yet. Difficulties met for ICP monitoring          implementation in infants and its invasive nature are often disliked by clinicians. A          non-invasive exam is then essential to allow a better care of children with ICH in          intensive care unit.   "
113827|NCT01796002|"     Primary objective of the study is to compare the efficacy of romidepsin when administered     with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma     (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria     for malignant lymphoma 1999 by RAC.   "
113828|NCT01795989|"     The purpose of this research study is to test the use of new Magnetic Resonance Imaging (MRI)     coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil is the     part of the MRI system that collects data to make the MR images. The investigators have     designed, developed, and built two child-sized coils to use when imaging elbows, wrists,     knees, and ankles. These new coils will be better suited to fit infants through teenagers     rather than the conventional coils used which were created for adults These MRI coils have     not been approved by the US Food and Drug Administration (FDA) and are considered     investigational devices.   "
113829|NCT01795976|"     This is a trial of adoptive T cell therapy using the patient's own T cells, genetically     engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous     cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white     blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the     laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide     (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The NY-ESO-1     gene modified cells will be re-infused on day 0 and the patients will receive up to 14 doses     of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4.      The primary objective of response rate according to Response Evaluation Criteria in Solid     Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12 and     at 12 weekly intervals thereafter.   "
113830|NCT01795963|"     The purpose of the present study is to examine the impact of ePREP when it is administered to     couples. More specifically, investigators will test whether--compared to placebo     controls--participants who receive ePREP will experience better outcomes for relationship     relevant variables.   "
113831|NCT01795950|"     The purpose of this clinical study is to assess the safety of PLX-PAD to treat pulmonary     arterial hypertension (PAH). PLX-PAD is a cell-based product made of allogeneic     Mesenchymal-like Adherent Stromal Cells (ASCs), derived from human full-term placentas     following an elective caesarean section. This year-long study will evaluate the safety of     three different dose levels of PLX-PAD, each given as a single intravenous infusion. This     study will also evaluate effects that PLX-PAD may have on PAH, such as changes in the ability     to exercise and on other tests used to measure the disease severity.   "
113832|NCT01795937|"     To investigate the effect of steady-state itraconazole on the pharmacokinetics of     steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose     pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the     single-dose pharmacokinetics of rosuvastatin   "
113833|NCT01795924|"     The purpose of this study is to determine whether PD-616 in combination with low-dose     Cytarabine is safe and effective in the treatment of untreated or relapsed/refractory acute     myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).   "
113834|NCT01795911|"     Substudy C: The purpose of this substudy is to determine whether Lambda combined with     Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with     genotype 1b chronic HCV infection   "
113835|NCT01795898|"     The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino     participants with osteoarthritis (disorder which is seen mostly in older persons in which the     joints become painful and stiff) and chronic (lasting a long time) low back pain.   "
113836|NCT01795885|"     The purpose of this study is to determine whether watching the MTV (Music Television)     television show 16 and Pregnant could affect teen girls' attitudes about teen pregnancy,     teen parenting, and pregnancy prevention. The investigators will recruit teen girls, ages     15-18, who will be randomized to the intervention group (who will be asked watch 4 episodes     of the show over a 4 week period) or the control group (who will not be intentionally exposed     to watching the show, and will not be told which show the intervention group is watching).     The investigators will evaluate, through survey, their attitudes about teen pregnancy and     teen parenting before and after the intervention period, and compare the two groups at the     conclusion of the study.      The investigators' hypothesis is that the teens that are exposed to watching the show will     have less favorable attitudes towards teen pregnancy and teen parenting than those teens who     are not exposed to watching the show.   "
113837|NCT01795872|"     This study assesses clinical and imaging long-term data, after early or delayed     interferon-beta-1b treatment in patients with a first demyelinating event suggestive of     multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly     Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main     objectives are to describe the disease course, change in disability, cognitive function,     resource use and employment status, in relation to Interferon beta-1b in the long term.   "
113838|NCT01795859|"     The purpose of this study is to determine whether SD-809 tablets are effective in the     treatment of chorea associated with Huntington's Disease.   "
113839|NCT01795846|"     The incidence of allergic rhinitis and asthma is increasing in throughout the world as well     as our country. Allergen-specific immunotherapy has been in use for almost 100 years. Since     then, it is recommended for the management of Immunoglobulin E (IgE)-mediated allergic     diseases as the only immune modulator therapeutic tool. It is well documented that allergen     immunotherapy performed using single allergen is efficacious in monosensitized patients.     Hence, polysensitization is much more prevalent than monosensitization in patients with     respiratory allergy. On the other hand, polysensitization may have a paramount relevance in     clinical practice; for example, many allergists have doubts in choosing the allergen extract     for allergen specific immunotherapy. In this regard, the evaluation of immunotherapy efficacy     in polysensitized patients still represents an unanswered question and there are very few     studies on this issue. However, most clinical trials of allergen immunotherapy have been     performed with multiple different allergen extracts using sublingual route. To the best of     our knowledge, no common single-allergen (house dust mite Dermatophagoides pteronyssinus, Der     p) subcutaneous immunotherapy trials have been specifically designed to compare efficacy in     monosensitized and polysensitized patients. Furthermore, few studies have demonstrated that     monosensitized and polysensitized patients appear to differ in terms of their immune     reactivity. But, it is unknown whether single-allergen immunotherapy protocol elicit distinct     immune responses in monosensitized and polysensitized patients.      The aim of this study was to investigate the immunological changes and clinical effectiveness     of most relevant single-allergen immunotherapy in patients with allergic rhinitis and/or     asthma. The study population will included 40 adult patients with moderate/severe perennial     allergic rhinitis and mild/moderate asthma who were monosensitized to house dust mites or     sensitized to at least 2 different allergens including house dust mites. No patient will     previously had been performed allergen immunotherapy. The study plan is prospective,     randomized, double-blind, placebo-controlled. Both groups will first received placebo     injections for 3 months, and followed by a cluster immunotherapy schedule. After the     maintenance dose will be reached within 6 weeks, injections will be received at monthly     intervals. Standardized depot preparations of Der p extract (Alutard Standard Quality SQ,     ALK-Abello (Company Name), Madrid, Spain ) were administered by means of subcutaneous     injection. All eligible patients will underwent 8 weeks run-in period to evaluate their     baseline clinical status based on history of allergy, symptom and medication usage for     rhinitis and asthma, skin prick testing, pulmonary function tests and methacholine     bronchoprovocation tests. According to the sensitizations, patients will be divided to 2     parallel groups either as polysensitized or monosensitized. Afterwards, both patient groups     will be followed by symptom and medication scales, visual analog scores, quality-of-life     scores for 1 month before placebo and immunotherapy. During this period, total serum IgE,     specific IgE levels will be measured using the method of UNI-CAP 100 (Phadia, Uppsala,     Sweden) and repeated after placebo and immunotherapy injections. At baseline, after placebo     (3 months) and immunotherapy injections (at third months of maintenance period), nasal     allergen provocation test with Der p extract will applied to the study groups. Peripheral     whole blood will drawn for the analysis of basophil activation marker CD203c (CD, cell     differentiation) expression at this three time points. For the clinical assessment, all     patients will record on diary cards their symptom scores, visual analog scale scores,     medication usage, quality-of-life measures for rhinitis and asthma. On each clinical visit,     physical examination and side effects will be collected from diary card data. In conclusion,     we believe that this study may be help for more understanding of the immune response to     allergen specific immunotherapy at early stage. On the other hand, if the similar clinical     improvement is demonstrated between the two groups with common single-allergen (Der p)     immunotherapy, unnecessary usage of multiple allergens may be prevented as well as     therapeutic side affects and cost.   "
113840|NCT01795833|"     Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent     clinical trials have demonstrated that it may be prevented by lifestyle intervention focused     on diet and physical activity. These trials have been expensive and labour intensive and this     has limited translation of the known benefits to the population at large.      We propose using a mobile phone intervention for lifestyle change and will assess it in a     clinical trial(study) in people with impaired glucose regulation (high risk at developing     type 2 diabetes).      The study will be conducted in both India and the UK. The purpose of the study is to assess     the effectiveness and acceptability of a text messaging system to prevent the progression to     diabetes in people with high risk. The study involves five visits to clinic over 2 year     period.      Study participants will be divided into two groups by the computer generated random method -     one is 'Usual Care' group and the other 'Text Messaging' group.        -  Usual care will consist of a 30 minute interview, delivering personalized diet and          exercise advice, supplemented by written material and education regarding diabetes. This          will be delivered once at the beginning of the study.        -  The intervention group will undergo the same initial interview and, in addition, will          receive 3 times weekly text messaging with education, advice, support and motivation.          These messages will be personalized to individual targets set at the initial interview.      The primary outcome will be progression to diabetes, with and without SMS intervention.     Secondary outcomes will be improvements in physical activity (reported and directly     measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL     cholesterol and serum triglycerides).   "
113841|NCT01795820|"     Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients     presenting with acute coronary syndrome. Such therapy is started with the administration of a     loading dose in patients which are not yet under treatment with P2Y12 inhibitors     (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a     satisfactory inhibition of platelet aggregation in patients who are already treated with a     previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound     ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet     aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or     without a loading starting dose of the newer drug.   "
113842|NCT01795794|"     Congenital Dyserythropoietic Anemia Type I (CDAI) is a recessive autosomal disease caused by     ineffective erythropoiesis that causes Anemia & accumulation of iron due to increased     absorption of iron in the intestine.      The iron is being accumulated in the body & causes damage of the liver, heart & endocrine     glands.      The standard follow up of iron levels is done by ferritin blood test & although the test is     not accurate it is the most available.      Medical treatment to removal of iron excess from the body is given in ferritin levels of     500-1000.      3 drugs are approved in the market:        -  Deferoxamine, given subcutaneous during the night, 5-7 nights/week and therefore is less          used today.        -  Deferiprone-given 3 times a day, is a weaker chelator, although it seems like it is good          to give it in combination with one of the 2 other drugs because it removes the iron from          the heart's cells better.      A rare but severe adverse effect is Agranulocytosis. This drug is usually not given in     childbirths.      -The 3rd drug which is mostly in use today is Deferasirox, given once daily, but has also     adverse effects, among them- damage of liver & kidney function, damage to the digestive     system, hearing and seeing.      Iron is being absorbed in acidic area, & thus drugs which decrease the acidity like hydrogen     pump's inhibitors, can inhibit the absorption of iron, and indeed there are reports that     these drugs decrease the absorption of iron and were used as treatment to hemochromatosis as     well.      Those hydrogen pump's inhibitors have also adverse effects. The rarest but most severe is     intestine infection by Clostridium.      In children, reports of adverse effects are minimal- mostly headaches & abdominal pains and     nosocomial infections. In adults, there are reports of fractures, magnesium deficiency &     vitamin B12 deficiency. All in all, the adverse effects are rare & uncommon.   "
113843|NCT01795781|"     New anticoagulants are being introduced to replace warfarin. These drugs do not require     monitoring and are safer. There is currently no recommended way to reverse these drugs     rapidly in the event of undue bleeding or need for emergency surgery. This is a lab study to     look at ways to reverse the drugs rapidly   "
113844|NCT01795768|"     To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2     amplified breast, squamous lung and stomach cancer whose cancers have progressed following     previous chemotherapy   "
113845|NCT01795755|"     The objective of the study is to assess the impact of horse assisted therapy (HAT) on:        -  Addiction treatment outcomes (its effectiveness as an alternative therapy)        -  Addiction treatment dropout & addiction relapse (its efficacy in preventing dropout).      Hypothesis: HAT will correlate with:        -  beneficial treatment outcomes of depression, anxiety, aggression        -  with improved self esteem & motivation        -  lower treatment dropout & addiction relapse.   "
113846|NCT01795742|"     This is an equivalence study comparing an electric nebulizer with a human-powered     nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma     exacerbations in a regional clinic in San Salvador, El Salvador.   "
113924|NCT01794715|"     Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a     pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.   "
113847|NCT01795729|"     The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary     intervention on top of medical therapy in the setting of heart transplant recipient coronary     artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite     of death, myocardial infarction, need for transitory or permanent ventricular assist device     implantation, myocardial revascularization, occurrence or worsening of heart failure, any     graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25%     compared to baseline. The hypothesis of the study is the superiority of the interventional     management over medical therapy alone in preventing the occurrence of the primary endpoint of     the study.   "
113848|NCT01795716|"     1. purpose: To conduct the relative bioavailability study of a single dose and multiple          doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus          Glivec (Novartis Pharma Stein AG).        2. Experimental Design： Two-period crossover design        3. Test drug: imatinib mesylate capsule Reference drug: Glivec        4. Sample size：20   "
113849|NCT01795703|"     The purpose of this study is to investigate the safety and efficacy of abiraterone in     participants with metastatic castration-resistant prostate cancer (mCRPC) who have received     docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents).   "
113850|NCT01795690|"     The purpose of this registry is to record information of routine treatment of anemia in     cancer patients in Germany. An overview of the current treatment of anemia in German     outpatient centers and hospitals will be provided. Primary outcome parameters, e.g.     improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of     different treatments will be analyzed.   "
113851|NCT01795677|"     JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT)     in patients with primary or secondary myelofibrosis : a prospective phase II   "
113852|NCT01795664|"     This study will be conducted as a randomized, double blind, double dummy two period crossover     study in stable asthma patients. A total of 16 stable asthma patients treated in accordance     with the Global Initiative for Asthma (GINA) guidelines, will be included.      Objectives:        -  The primary objective of this study is to evaluate the effect of both the study drugs          under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate          the particle deposition in the lungs using Computational Fluid Dynamic (CFD)        -  The secondary objectives are to assess the effect of both the study drugs on lung          function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking          Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog          Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will          be evaluated through monitoring of adverse events (AEs) throughout the study.   "
113853|NCT01795651|"     Medical education involves the acquisition of a large quantity of information. Lecture-based     learning (LBL) is the best known of conventional teaching methods. Two thirds of critical     care junior doctors identified at best only one of the three main take-home messages of a     lecture, suggesting that knowledge transfer is poor during passive format learning.      The investigators assess the impact of an intervention including the identification of     take-home message of lecture with slides calling Learning Objectives, Message,     Conclusion, in the identification of take-home message in critical care junior doctors.   "
113854|NCT01795638|"     Adequate growth during the neonatal period is critical for optimal long term outcomes.     Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to     thrive suggesting that factors other than total calorie intake are important in ensuring     consistent weight gain. Several reports have indicated a positive sodium balance is critical     in ensuring good weight gain in very low birth weight infants, however these infants are     susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to     diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but     there is no evidence for this practice in preterm neonates. Our central hypothesis is that     early supplementation with sodium will ensure positive sodium balance in very low birth     weight infants and will result in optimal weight gain and enhanced long term outcomes.     Secondarily we hypothesize that low sodium concentrations in the urine will not correlate     with low serum sodium values.   "
113855|NCT01795625|"     The evaluation will determine professional clinical accuracy comparing the OneTouch®     Verio™Pro+ blood glucose results with the YSI 2300 analyzer. Professional Clinical Accuracy     is defined as accuracy of the system when used by a trained healthcare professional.   "
113856|NCT01795612|"     Physical exercise has been identified as a major item of many chronic diseases and cancer     rehabilitation. It contributes to an improvement in the quality of life and to a decrease in     the current treatment side effects and mortality. Cancer in association with treatment     toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems     in daily activities. The physical capacity and the tolerance for exercise fall simultaneously     leading to a deconditioning vicious circle which increases physical, psychological and     emotional symptoms of fatigue. Therefore, physical activity for health is a valid and     relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the     study is the assessment of the effects of a physical activity retraining program on aerobic     capacity, strength and fatigue, in a breast cancer population treated by adjuvant or     néoadjuvant chemotherapy.   "
113880|NCT01795300|"     In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon     radiotherapy in patients with skull base meningiomas. There will be two treatment arms with     photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional     fractionation. The study is designed as descriptive study on feasibility of the investigated     therapies aiming at a comparison of toxicities. The study will serve as a basis for further     larger randomized protocols comparing efficacy of the therapies, assuming toxicity is     comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are     overall survival, progression-free survival and quality of life.   "
113942|NCT01794481|"     The purpose of this study is to evaluate the potential benefit of an individualized     resistance exercise-training program during radiotherapy for patients with locally advanced     head and neck cancer.   "
118403|NCT01736163|"     The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen     and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour     based on historical diagnostic whole body scan (DxWBS) records.   "
113857|NCT01795599|"     More than 100 000 surgical abortions are annually performed in France. About four in ten     women will have an abortion in their life. Abortion complications are cervical tearing     (0.1-1.18%), uterine perforation (0.09-19.8‰), hemorrhage (1.5‰) and infection (5-20%). These     complications can first compromise the vital prognosis and are involved in 10% of the     worldwide maternal mortality (20 000 women by year), then lead to infertility which is hard     to treat (uterine synechiae) or impossible to treat (hysterectomy for control of bleeding),     and are finally responsible for obstetrical pathologies as late miscarriages or premature     delivery due to cervical insufficiency. All that complications are linked to cervical     laceration of the surgical abortion, that can be reduced by the recommended use of     mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks.     However, it does not exist data evaluating the superiority of one of the two molecules or     their combination. These data could optimize the cervical preparation and thus reduce the     abortion complications with a direct impact on maternal mortality, infertility and     obstetrical complications. Thus, it seems to be important to evaluate these two molecules and     their combination.      Objectives To compare mifepristone, misoprostol and their combination in the cervical     preparation of the surgical abortion between 12 and14 weeks for their efficacy, complications     and side-effects.   "
113858|NCT01795586|"     This study is being done to see how safe the combination of eribulin and carboplatin is and     if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both     chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which     control every function in the body. Some cells stop working like they should and become     cancer cells. These cancer cells grow and multiply rapidly and can cause destruction to     normal body organs. Eribulin and carboplatin have both been approved by United States Food     and Drug Administration (FDA) for use in the treatment of breast cancer. The combination of     these two drugs and the safest dose of eribulin to use is experimental.   "
113859|NCT01795573|"     Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute     graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling     transplants.   "
113860|NCT01795560|"     Follow up via ultrasonic abdoman after patients who were giagnosed and treated as     periappendicular abcess and refused to be operated later on in the interval period . To ass     what occured to their appendics ?   "
113861|NCT01795547|"     To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of     patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical     Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care     setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.   "
113862|NCT01795534|"     The study will aim to describe and evaluate the effect of beetroot juice supplementation upon     whole body running exercise at altitude. It is hypothesised that beetroot supplementation     will decrease time to complete a 10 km time trial.   "
113863|NCT01795521|"     Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung     cancer in the European Union of 52/100.000 per year and a mortality of 47/100.000 per year.     Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all cases. The five year     survival of NSCLC patients is quite poor (16%), mainly due to patients being diagnosed at     advanced stages. However if lung cancer can be detected and treated at an earlier stage the     outcome and survival is much more favorable with five year survival rates up to 77%.      The current standard of care for small volume tumors is surgical resection in medically fit     patients, consisting in lobectomy or pneumonectomy accompanied by a systematic mediastinal     lymph node sampling or lymphadenectomy. For the patient population with small volume disease     at early stage surgery offers the potential of local tumor control in up to 96% of the     patients.      However, about one quarter of the patients is medically inoperable because of coexisting     morbidities or poor general condition, mostly the result of a long smoking history and     consecutive chronic Obstructive pulmonary disease (COPD) and coronary artery disease (CAD).      The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided     stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally     located NSCLC and in those who are not willing to undergo surgical treatment.      Secondary objectives of the study are        -  to assess safety of the treatment modality by collecting data about acute and late          toxicity        -  patterns of local and distant recurrence and relation between the site of local          recurrence and the clinical (CTV) and planning target volume (PTV)        -  survival and cause of death   "
113864|NCT01795508|"     The purpose of the study is to examine the effects of Parent Management Training Oregon     (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing     behavioral problems.   "
113865|NCT01795495|"     Significant pain may occur following posterior spinal fusion despite the use of     conventionally accepted techniques including patient controlled analgesia. If detected, a     significant reduction in opioid requirements may lead to improved patient satisfaction and     decreased opiate side effects.      The current study would use a prospective, randomized trial investigating the efficacy of one     of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along     with a third control group. The patients would be randomized to receive remifentanil plus a     single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of     magnesium; or remifentanil alone. In addition, the two medications being studied might make     it easier to determine the efficacy of neurophysiologic monitoring including somatosensory     evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA)     required to elicit the response.      The purpose of this study would be to explore the effects of intraoperative methadone vs     magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the     efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of     desflurane, remifentanil, and the need for intraoperative supplemental agents to control     blood pressure.   "
113866|NCT01795482|"     The study should evaluate how long patients undergoing major abdominal surgery under combined     general/epidural anaesthesia have to be actively warmed preoperatively to prevent     perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air     skin-surface warming for different duration. Body temperature will be measured at the     tympanic membrane. The investigators hypothesize that active warming before starting the     epidural anaesthesia will decrease the incidence of perioperative hypothermia.   "
113867|NCT01795469|"     Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance     in adolescents and adults. Compression stockings are commonly recommended as a treatment     modality for POTS, but the effects of abdominal and lower extremity compression during tilt     table testing have not been measured in adolescent patients. The aims of our study are to     compare heart-rate changes and symptom onset during tilt table testing (a) with and without     abdomen/lower extremity compression and (b) with abdominal compression only versus lower     extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10     minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full     compression (trial #2), and a third study without compression up to 10 minutes (trial #3).     Compression will be performed using the non-inflatable Zoex anti-shock garment. During study     phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt     without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression     only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated     without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we     will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower     extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4     (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart     rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare     mean heart rates between trials for each study phase. Hazard analyses will be used to assess     time-based endpoints.   "
113868|NCT01795456|"     The purpose of this study is to evaluate the ability of contrast enhanced carotid ultrasound     to serve as an indicator of disease activity in patients with Takayasu's arteritis or Giant     Cell arteritis and to determine if patients with active arteritis have a thickening of their     blood vessel walls compared to healthy people of the same age and gender.   "
113869|NCT01795443|"     The primary objective of this study is to compare the lumbar proprioception of patients with     chronic back pain to that of healthy volunteers during low- and high-frequency muscle     vibration.      The order of measures (low frequency of vibration, high frequency vibration and no vibration)     is randomized in a cross-over design.      Patients and volunteers are matched by age and body mass index.   "
113870|NCT01795430|"     This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and     high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk Ewing     sarcoma. Giving chemotherapy and radiation therapy before a peripheral blood stem cell or     bone marrow transplant stops the growth of tumor cells by stopping them from dividing or     killing them. After treatment, stem cells are collected from the patient's blood and stored.     More chemotherapy is given to prepare the bone marrow for stem cell transplant. The stem     cells are then returned to the patient to replace the blood-forming cells that were destroyed     by the chemotherapy   "
113871|NCT01795417|"     To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in     4 weekly applications to human periorbital skin area by grating pre- and 90-days post     treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded     evaluators.   "
113872|NCT01795404|"     A cancer diagnosis is a stressful phenomenon and a life-threatening experience that creates     immediate psychosocial distress for the patient and his or her family. Distress is also     experienced across the disease trajectory. Stress can manifest in a variety of psychological     symptoms, such as anxiety and depression, intrusive cancer-related thoughts, or physical     symptoms, such as fatigue, increased pain, and impaired sleep. Intensified stress in cancer     patients has been associated with increased morbidity and mortality, decreased immune     function, increased relapse, and decreased health-related quality of life. Given the known     negative impact of stress on cancer patients, stress has become a priority issue in cancer     treatment and research. Targeting stress-related variables with psychosocial interventions     has been an important emphasis in cancer-care models. One of these care modalities is     Inquiry-based stress reduction.      The IBSR intervention, developed by Byron Katie, is a simple yet powerful process of inquiry     that teaches the individual to identify and question the thoughts that cause him or her to     experience stress and suffering. It is a way to understand what is hurting the individual,     and to address the cause of his or her problems with clarity. This mindful-process, named     The Work, facilitates that through four questions and a turnaround, which is a way of     experiencing the opposite of what the individual believes in. The Work provides skills for     self-inquiry and management of stressful thoughts which can be easily implemented in daily     life. The study will focus on breast, colorectal and prostate cancer patients. These types of     cancers have high incidence along with high survival rates.      The primary objective is to examine the feasibility and effectiveness of IBSR for breast,     colorectal and prostate cancer survivors on quality of life. We hypothesize that this     intervention will lead to significant improvements in all quality of life domains (physical     well-being, psychological well-being, social well-being etc.)      Effects on secondary outcomes will be assessed, including depressive symptoms, anxiety and     stress levels, and fear of recurrence. Physical symptoms (disturbance in sleeping patterns,     fatigue, and pain), will be assessed as well. Biological measurements will be measured in     blood samples in order to observe effects on neural and immune components.      Additionally, we are interested in evaluating whether positive effects achieved from the IBSR     program are modified by specific patient characteristics measured at baseline (optimism,     social support, and spirituality).   "
113873|NCT01795391|"     Intravascular devices in intensive care units are often associated to complications. The     investigators estimate that 23.5% of catheters placed and used in intensive care are subject     to at least one complication; the goal is to demonstrate the effectiveness of the new     Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications     associated with intravascular catheters in intensive care.   "
113874|NCT01795378|"     The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells     that are given after HLA-mismatched hematopoietic cell transplantation.   "
113875|NCT01795365|"     Active Surveillance manages selected men with prostate cancer expectantly with curative     intent. This means men are carefully selected and subsequently actively observed in order to     have the possibility to offer them curative treatment once the tumor seems to progress.      The goal of this study is to validate the treatment option Active Surveillance in men with     localized, well differentiated prostate cancer, in order to limit the amount of     overtreatment. A number of key points will be studied, such as the pathological findings in     radical prostatectomy specimens, and the effect of expectancy on the quality of life.   "
113876|NCT01795352|"     This is a national, multicentre, non-interventional, retrospective study to be carried out in     the oncology settings of approximately 15-20 Spanish hospitals.      At each participant hospital, all patients recently diagnosed with advanced EGFR mutated     NSCLC (both newly or with recurrent disease , without previous treatment for metastatic     disease) from April 2010 to December 2011 will be included as study population. Information     about the follow-up of the patients during a minimum of 12 months after diagnosis will be     collected.   "
127729|NCT01613183|"     The objective of this study is to screen the effective core formulation in insomnia treatment     with Chinese medicine with a double-blind, randomized, placebo-controlled trial.   "
113881|NCT01795287|"     There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft     fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack     of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during     flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal     pulses are late symptoms of ACS.      Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide     the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is     based on old patient-series and single case-reports. Some of these studies report the     symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions     in these studies cannot be confirmed by an expert of RA. It is also possible that there are     more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS.     There are no modern, randomized and controlled studies of the safety of RA in patients with     tibial shaft fracture.   "
113882|NCT01795274|"     The physical and biological properties of the carbon ion beam promise to improve the     therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose     deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak     can be directed into the defined target volume, and the sharp dose fall-off thereafter again     spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been     shown also for pancreatic cancer cell lines in the preclinical setting, is likely to     contribute to an increase in local control, and perhaps in OS. Early data from Japanese     centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate     actively delivered carbon ion beams in patients with locally advanced pancreatic cancer     within a dose-escalation strategy.   "
113883|NCT01795261|"     The purpose of this study is to determine if providing free laboratory test to pregnant women     and their spouses at churches, in addition to laboratories or hospitals, will increase the     number of pregnant women and their spouses who get screened for HIV, malaria, sickle cell     trait, hemoglobin levels, syphilis, and hepatitis B. These tests are necessary to keep     mothers healthy during pregnancy and lead to healthy babies. This research is taking place in     40 churches in Nigeria.   "
113884|NCT01795248|"     It is well-known that women with previous gestational diabetes mellitus are in risk of     developing type 2 diabetes later in life; approximately half of the women develop overt type     2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the     effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous     gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.   "
113885|NCT01795235|"     Glucagon has been used for decades as a test of growth hormone (GH) reserve. The pathway by     which GH is stimulated by glucagon is not established. Acyl ghrelin has been shown to     increase GH levels and to be stimulated by an increase in adrenergic activity. The proposed     study will test the concept that with the fall in blood glucose it is likely that there is a     sympathetic discharge which contributes to the increase in acyl ghrelin and indirectly leads     to the increase in GH and cortisol.   "
113886|NCT01795222|"     Evaluation of oral midazolam to improve children's behavior and reduces the stress and     anxiety during dental treatment   "
113887|NCT01795209|"     The purpose of this study is to determine the effect of ranibizumab for the treatment of     macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial     fair visual acuity.   "
113888|NCT01795196|"     Integrated pulmonary index (IPI) is a tool that monitors respiratory status. It takes into     account four parameters: respiratory rate, end-tidal CO2, heart rate and O2 saturation using     a pulse oximeter and specialized sidestream CO2 monitor. The device can continuously monitor     and display the patient's ventilatory state as a single digit, 1-10. In addition, trends can     be kept and it can provide early indication of changes in respiratory status. IPI has only     been studied in pediatric patients who are under sedation; however, more uses for the     monitoring tool are a possibility. One of those possibilities is to use IPI to monitor     pediatric patients during the weaning and extubation process to determine if a specific     number, or less than a specific number, is associated with extubation failure. Therefore,     clinicians and physicians would be better able to determine if the patient is ready for     extubation.   "
113889|NCT01795183|"     Primary Objective:      To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia      Secondary Objective:      To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.   "
113890|NCT01795170|"     Restricting dietary lysine intake in infants from age 3 months or less with confirmed     diagnosis of pyridoxine-dependent epilepsy due to Antiquitin (ATQ) deficiency will: reduce     the accumulation of neurotoxic substratesα-aminoadipicsemialdehydeandits cyclic equivalent     1-piperideine-6-carboxylate;and will improve overall neurodevelopmental outcome at 3 years of     age by acting as an effective intervention into the complex pathophysiology of the condition.   "
113891|NCT01795157|"     This study aims to investigate computer based symptom assessment in an outpatient cancer     population, and the use of a computer based decision support system to facilitate the     diagnosis and treatment of cancer related pain.      Primary hypothesis is, that this approach improves pain control and pain management in an     unselected group of cancer patients in an outpatient setting.        -  Improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale        -  Improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale        -  An alteration in the prescribing dose of opioids in equipotent opioid dosage      Secondary hypothesis is, that this system improves overall symptom control and symptom     management in an unselected group of cancer patients in an outpatient setting.   "
113892|NCT01795144|"     The purpose of this study is to explore the mechanisms of metabolic control in monogenic     diabetes patients treated with sulfonylurea medications.   "
113920|NCT01794767|"     The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a     longer or equal duration of patency of peripheral venous catheters, compared with heparin     solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge     catheters Will be included in the study.The study will assess in particular:        -  the difference of permanence in situ of the device        -  the difference in incidence of complications (in detail: obstruction, phlebitis,          thrombocytopenia, systemic anticoagulation)        -  the difference in costs between use of saline normal saline 0.9% NaCl solution and          heparinized 50 U / ml.   "
113893|NCT01795131|"     Nutritional anemia is a major public health problem among children and women in developing     countries. Despite ongoing national program of supplementing pregnant women with iron-folate,     prevalence of anemia is 39% among pregnant women and 78% among infants in Bangladesh. Vitamin     B12 deficiency is a more prevalent cause of megaloblastic anemia than folate in many     developing countries. This data raises the interest to address the role of vitamin B12     deficiency in nutritional anemia. Low dietary intake of animal products, a predominant source     of vitamin B12 may cause anemia. Besides maintaining normal erythropoiesis, B12 is essential     for immune function. However, no studies have evaluated the effect of maternal B12     supplementation on reduction of anemia and improving immunity of their infants. The     investigators hypothesize that vitamin B12 supplementation plus iron-folate during pregnancy     and 3-mo postpartum would: (a) Decrease anemia among mothers and infants; (b) Improve vaccine     specific cellular and humoral immune responses among mothers; (c) Improve vaccine specific     immunity in infants by passive transfer; (d) Improve DNA methylation and one-carbon     metabolism in mother-child pairs; (e) Reduce antenatal/postnatal depression. Results from     this study will guide and provide support to the policy makers to identify effective     strategies to reduce nutritional anemia in population at risk.      The investigators aim to conduct a double-masked placebo controlled trial to investigate the     added effect of vitamin B12 on the iron-folate supplementation among pregnant women. Anemic     (Hb level <11.0 g/dl) mothers at 11-14 weeks of gestation will be randomized into two groups:     supplement group will receive 250 ug vitamin B12 plus 400 ug folate and 60 mg iron; placebo     group will receive folate and iron only. This daily supplementation will continue up to 3-mo     postpartum. At 26-28 wk of gestation mothers will be given inactivated influenza vaccine.     Data on anthropometric indices of mothers and children, birth size, infant growth and     morbidity (mothers and children) throughout the study period will be recorded. 24-h dietary     recall data will be collected from the mothers bimonthly throughout the study. Biochemical     indicators of anemia including Hb, vitamin B12, ferritin, folate and α-glycoprotein (AGP)     will be assessed in plasma of mothers (pre- and post-supplementation) and infants (cord blood     and 3-months). Additional measurements include serum transferrin receptor (sTfR) in plasma     and methyl malonic acid (MMA) and total homocysteine (tHcy) in the urine of mothers. Plasma     vaccine specific antibody responses will be measured in mothers (pre- and post     supplementation) and in infants (cord blood and 3-months). In breast milk, B12, folate and     s-IgA will be determined. Genetic polymorphism (one-carbon metabolism) and DNA methylation     will be studied in mothers and in cord blood.   "
113894|NCT01795105|"     This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean     regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA     Notification No. 2010-94 dated 27 December 2010).   "
113895|NCT01795092|"     This is a randomized, controlled study to compare patients evaluated by primary care     physicians alone versus patients who are additionally evaluated by a dermatologist at the     primary care physician‟s office, aiming to demonstrate that visits to the primary care     physician‟s (PCP) office that involve both the PCP and an on-site dermatology consultation     will reduce hospital admission rates. The hypothesis of this study is that obtaining     outpatient dermatology consultations during a patient‟s initial presentation to a primary     care office will reduce admissions for cellulitis with accuracy. The primary objective will     be to measure the difference in the proportion of patients requiring hospital admission     utilizing a dermatology consultation at the PCP‟s office (active arm) versus primary care     evaluation alone (control arm) by calculating risk ratios and risk differences. The risk of     admission for each arm will be assessed once the study has been completed. The secondary     endpoint will be admission versus discharge home at a dermatology follow-up visit to assess     accuracy of initial assessment. An additional endpoint will be to determine if any     differences in frequencies of cellulitis and admission exist based on age and     immunosuppression. Exploratory analyses will assess the percentage of patients with a     concomitant known predisposing factor for recurrent cellulitis such as lymphedema, leg     ulceration, tinea pedis, or onychomycosis, as well as the association of fever >100.5 F and a     history of a prior episode of cellulitis.   "
113896|NCT01795079|"     The purpose of this study is to see the effects of transcranial direct current stimulation     (tDCS) on the pain and itching associated with burn injury. This study is part of the     Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease     in pain levels with active stimulation, when compared to sham stimulation, using a 3 week     stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of     stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after     initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks     after the second course of stimulation.      If a subject receives sham during the experiment, he/she may enroll in an open-label portion     of the study and receive 10 days of active stimulation.   "
113897|NCT01795066|"     For 12 months after approvement by the University of Yonsei institutional review board, of     the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all     consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The     inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic     masses according to clinical evaluation and imaging studies with need of histologic tissue     confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the following: cystic     pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy     (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter     [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability     or refusal to give informed consent, and refusal to participate in the study. Patients     undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued     treatment at least 5 days before the endoscopic procedure. Written informed consent was     obtained from all patients for the procedures performed and participation in the study, and     the study protocol was approved by the University of Yonsei institutional review board. All     patients were underwent the procedure under conscious sedation with propofol and midazolam     according to the current guidelines.8 After procedure, the patients were monitored for at     least six hours in order to immediately detect post-procedural complications and were     followed for up to 7 days in order to detect late complications.   "
113898|NCT01795053|"     A sample of 60 children is randomly assigned to an intervention and a control condition. The     intervention group receives 15 sessions of child-focused treatment with play training to     enhance play persistence and intensity. The control group receives the same amount of placebo     play sessions. The intervention group receives subsequently 15 sessions of parent training.     All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD. Main     hypothesis are a stronger reduction of ADHD symptoms of the child in different settings in     the intervention than in the control group. Play-persistence and -intensity should also     increase more in the intervention group. An additional effect of a subsequent parent training     shall furthermore be tested.   "
113899|NCT01795040|"     The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS     symptoms will be evaluated in a randomised controlled doubleblind trail with children aged     3-6 years.   "
114226|NCT01790724|"     The propose of the study is to test the hypothesis that an eight week program consisting of     walking exercise and social cognitive theory based group workshops will increase physical     activity adherence six months later in older adults with type 2 diabetes or metabolic     syndrome.   "
113900|NCT01795027|"     Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients     with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of     the standard therapies to these patients. But it is still unknown whether it would improve     more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed     to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as     adjuvant chemotherapy after D2 resection in patients with gastric cancer.      Patients and methods: In this study , patients with histologically confirmed gastric cancer     who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern     Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized     1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a 21-days     cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end     of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14 days in a     21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is     overall survival (OS), and secondary end point is disease free survival(DFS) and safety.     Final study analysis will be conducted in the end of the 5th year after the last patient's     enrollment.   "
113901|NCT01795014|"     A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can     potentially be found in up to 98% of healthy individuals. In fact, the lack of this     spontaneous retinal venous pulse has been consistently implicated as an indicator of a more     advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the     mechanisms behind these change in the retinal venous system are not clear. Some evidence     suggests that extraocular features such as intracranial pressure (ICP) may play a role in     regulating the intraocular venous outflow. The reasons for this hypothetical downstream     resistance to venous outflow are not fully understood, with advances in this field being     limited by our technological-imposed difficulties in assessing the structures behind the     globe.      However, it has been established that the volume of cerebrospinal fluid surrounding the optic     nerve correlates with the ICP at the orbital level. Recent studies have suggested that     non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with     the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range     (normal tension glaucoma - NTG).      The investigators will therefore conduct a test to determine if this cerebrospinal volume     surrounding the optic nerve correlates with the frequency of observation of an otherwise     signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein)     Additionally, the investigators will assess if this correlation is different between healthy     individuals, hypertensive primary-open angle glaucoma or NTG patients.   "
113902|NCT01795001|"     The purpose of this study is to gain further insights into the molecular pathogenesis of     Fuchs' endothelial corneal dystrophy (FECD), to identify targets for potential specific drug     therapy.   "
113903|NCT01794988|"     The purpose of this study is to investigate whether a psycho-therapeutic approach, group     Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive     Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural     circuitry associated with chronic pain.   "
113904|NCT01794975|"     The primary objective of the study is to further investigate whether striatal [11C]ORM-13070     uptake can be reduced by physiological and pharmacological challenges that increase the     synaptic concentrations of noradrenaline in the human brain. Each subject will undergo 3 PET     scans, a baseline PET scan and two scans with noradrenaline challenges: intravenous     administration of ketamine and oral administration of atomoxetine combined with a cold     pressor test where the subject's foot is placed in an 8 °C water basin. Eight healthy male     subjects will be included in the study.   "
113905|NCT01794962|"     This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients     receive a specific diagnosis, leaving the majority of patients diagnosed with non specific     low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This     pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises     to a classification based biopsychosocial intervention (a cognitive/functional approach) as     described by Peter O`Sullivan, on a subgroup called flexion pattern      This pilot study has three specific aims:      (i) To determine the mean and standard deviation on the numerical rating scale of     participants in this setting who have a motor control flexion pattern, so that sample size     calculations for a fully powered randomized controlled trial could be performed.      (ii) To test the logistical and practical procedures that will be required to perform a fully     powered randomized controlled trial using these two treatments.      (iii) To gain a preliminary estimate of any difference in the effect of these two treatments,     so as to determine if the results of a fully powered randomized controlled trial might be     clinically important and therefore worthwhile undertaking   "
113906|NCT01794949|"     The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by     poor healing of the stented area. This will require the combined use of blood thinners such     as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications     such as clot formation on the stent which may lead to a heart attack. Diabetic patients and     those presenting with a heart attack at the time of stent placement are at increased risk for     clot formation. However, little is known of the healing responses after stent placement in     these populations.      Currently all patients receiving DES are advised to complete DAPT for twelve months although     more personalized durations of DAPT based on stent healing would reduce both clot formation     and potential bleeding from the blood thinners, thereby improving the long-term safety of     DES.      Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive     imaging technique that has the ability to evaluate stent healing at follow-up. Among the     commercially available coated stents used in the U.S., the zotarolimus eluting stents     (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both     preclinical and clinical studies.      The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity     stent as detected by OFDI in patients with and without diabetes presenting with ACS.     Specifically, in this observational study, the study team will investigate non-insulin     dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent     placement.      The investigators hypothesize that healing responses in patients with non-insulin dependent     diabetes will be similar to those without diabetes presenting with ACS and that a majority of     patients will demonstrate complete healing as determined by OFDI measurements.   "
113921|NCT01794754|"     The purpose of the study is to investigate if occupational therapy may delay or prevent the     need for surgery in patients with carpometacarpal(CMC) osteoarthritis (OA) who are scheduled     for surgery in the CMC-joint.      Our study hypothesis is that compared to participants in the intervention group,     significantly more participants in the control group have received CMC-surgery after two     years.   "
113922|NCT01794741|"     This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with     allergic rhinitis   "
113907|NCT01794936|"     This study is designed to evaluate the use of a disposable laparoscopic Doppler probe in     robotic assisted prostatectomies. The Vascular Technology, Inc. (VTI) laparoscopic probe is     simply a sterile, disposable Doppler probe that can be inserted through a laparoscopic trocar     and placed on structures to determine if there is vascular flow demonstrating an audible     pulse. During robotic-assisted prostatectomy, identification of vasculature is critical in     order to prevent hemorrhage and effectively treat the underlying pathology. The investigators     routinely utilize a combined Doppler ultrasound laparoscopic probe to identify vasculature     during renal surgery, but Doppler ultrasound usage has not been adopted for prostatic     surgery.      From a mechanical standpoint, these combination probes differ from the VTI probe in that they     are approximately 2 times the diameter of the VTI probe, and the portion of the probe     utilized for imaging much longer and on the side of the device. The VTI probe is much     narrower, and the portion of the probe utilized for vessel identification is at the tip of     the probe. For robotic-assisted prostatectomy, patients will be randomized to VTI     laparoscopic Doppler System to identify pedicles and neurovascular bundles (NVB) or to     robotic-assisted laparoscopic prostatectomy with no Doppler probe, which is the current     standard of care.   "
113908|NCT01794923|"     The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel     versus placebo administered two or three times daily for the treatment of pain associated     with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor     muscles.   "
113909|NCT01794910|"     Aim: To determine the effects of pelvic floor muscle training (PFMT) in women with a single     delivery route. Pregnancy and delivery route alter the pelvic floor muscle strength and are     considered risk factors for urinary incontinence and genital dystopias. Methods: A Randomized     controlled clinical trial with two hundred ninety-seven women aged 35 to 45 years old were     selected for functional assessments of their pelvic floors by vaginal digital palpation and     perineometry. One hundred sixty-five (69.7%) exhibited muscle strength deficits and were     included in the clinical trial. The participants were distributed into two groups based on     the delivery route (A, vaginal delivery and B, cesarean delivery) and were then randomly     subdivided into Groups A1 (n = 44) and B1 (n = 42), who performed PFMT, and Groups A2 (n =     39) and B2 (n = 40), who did not undergo muscle training. The PFMT involved perineal     contraction exercises in the dorsal decubitus, sitting, and standing positions and was     applied twice per week for a total of 15 sessions. The functional assessment of pelvic floor     by vaginal digital palpation and perineometry was performed after 15 sessions of pelvic´s     floor muscles training. The statistical analysis was performed using the Mann-Whitney and Z     tests at a 5% level of significance.   "
113910|NCT01794897|"     The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional     antipsychotic drug treatment will be evaluated among patients with schizophrenia who have     been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV)     augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1     (HSV-1) exposed early course schizophrenia patients.   "
113911|NCT01794884|"     In view of the lack of large-scale clinical study and potent evidence-based medicine, the     investigators designed a randomized, double-blind, placebo-controlled study to ascertain     whether preoperative intravenous administration with glutamine can improve the postoperative     cardiac function and prognosis of adult patients undergoing cardiac surgery. The     investigators want to detect the levels of myocardial protein O-GlcNAc modification and HSP70     expression, changes in sensitive indicators of myocardial injury, systemic inflammatory     reaction and oxidative stress levels, and to examine the correlation between these changes     and Clinical manifestations. The ultimate goal of the study is to explore a new way for     clinical myocardial protection.   "
113912|NCT01794871|"     Identify the cause of chronic allograft dysfunction using a combination of comprehensive     clinical and histologic information in Chinese renal transplant recipients, then to identify     the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual     impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor     [CNI]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered one     of the major causes of CAD, however, recently there has been found most death-censored graft     losses to be the result of alloimmune or autoimmune injury, with only a minority of cases     attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in CAD in     China is not well analyzed. To improve perception of Neo safety with more local evidence, we     want to do a retrospective study to identify the cause of chronic allograft dysfunction using     a combination of comprehensive clinical and histologic information in Chinese renal     transplantation recipients.   "
113913|NCT01794858|"     Background: Acute pancreatitis is characterized by a high mortality rate (10%-15%), and a     remarkably unpredictable clinical course. Approximately 50% of deaths in acute pancreatitis     occur early—within the first 14 days—and early mortality is attributable to sequelae of a     severe systemic inflammatory response syndrome (SIRS), which is associated with multi-organ     dysfunction syndrome (MODS) that can escalate to renal failure, respiratory failure, and     death. Significant improvements in acute pancreatitis mortality will demand innovative     approaches to counteract early organ failure. A series of destructive cellular processes     begins within minutes of initial pancreatic injury, and the ensuing inflammatory cascade is     compounded by disease sequelae including edema, ischemia, and tissue necrosis. Early     interventions to reduce inflammation within the first 36 hours have been shown to have     significant effects in minimizing progressive organ dysfunction.      Hypothermia is clinically employed to combat cellular injury and systemic responses following     ischemia-reperfusion, and is been studied as a mechanism of acute inflammatory inhibition in     processes including cardiogenic shock, lung injury, local intestinal injury, and reperfusion     injuries to the lung, liver, and endothelium. In numerous studies, effective     immunomodulations have been observed including reduction of pro-inflammatory cytokines     (TNF-α, IL-6), stimulation of anti-inflammatory cytokines (IL-10), inhibition of     pro-apoptotic JNK signaling, reduction of systemic oxidative stress, and inhibition of     neutrophils, monocytes, and monocyte-derived macrophages. Most saliently, in the caerulein     model of murine acute pancreatitis, therapeutic hypothermia has been shown to reduce serum     IL-1, IL-6, and TNF-α, increased serum IL-10, decrease serum amylase and lipase, lower the     histological grade of pancreatic injury as compared to normothermic mice, and significant     survival benefit. Although therapeutic hypothermia is actively employed in the treatment of     traumatic brain injury, neonatal asphyxia, spinal cord injury, and cardiac arrest, no studies     have yet been made of its application to acute pancreatitis.      Hypothesis: Patients treated with therapeutic hypothermia (32-34°C) will sustain reduced     organ-specific injury in acute pancreatitis.      Proposal: In a Phase IIa pilot clinical trial, we will examine the effects of therapeutic     hypothermia on organ-specific outcomes during the early stage of acute pancreatitis. We will     recruit five patients aged 18 to 80 receiving medically-necessitated ventilator support under     ICU monitoring with core temperatures ≥36°C and severe acute pancreatitis defined as either a     Ranson Score ≥7, a CT indicating ≥50% pancreatic necrosis, or a significant deterioration in     clinical status including dysfunction of two or more organ systems (defined by ACCP/SCCM     Organ Failure Guidelines, Chest 2009). All patients will receive current standard management     for severe acute pancreatitis and a standardized protocol for application of therapeutic     hypothermia and rewarming. Our primary endpoints are organ-specific cardiovascular,     respiratory, hematological, renal, and metabolic dysfunction as measured at 28 days. Logistic     Organ Dysfunction Scores (LOD) will be compared before and after therapeutic hypothermia,     establishing day 4 versus day 1 changes in LOD. Secondary endpoints include D-dimer, IL-6,     C-reactive protein, APACHE II scores on day 1 and day 4, inpatient and ICU length-of-stay,     infection, mortality, and hypothermia-associated side effects including cardiac arrhythmia,     electrolyte imbalance, hyperglycemia, major bleeding, and acute pancreatitis. We believe that     such a study will supply preliminary answers to our chief research questions: does     therapeutic hypothermia reduce morbidity as assessed by organ-specific outcomes, does     therapeutic hypothermia attenuate the steep rise in inflammation observed in severe acute     pancreatitis, and does therapeutic hypothermia shorten the clinical course for these     patients.   "
113914|NCT01794845|"     Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of     patients with recurrent unresectable head and neck squamous cell carcinoma.   "
113915|NCT01794832|"     Our main hypothesis on the present study is that new parameters such as risk-taking behavior,     patients motivation, health related quality of life, new biomarkers and more precise     echocardiography measures in addition to traditional parameters will improve pre-operative     risk assessment in patients with AS and better guide patients and doctors in decision whether     to operate or not.   "
113916|NCT01794819|"     The aim of this study is to evaluate the usefulness in Russian general practice of C-reactive     protein testing in patients with acute cough or lower respiratory tract infections.      In addition to studying the effect of C-reactive protein testing on the prescription of     antibiotics, the purpose is to find out whether the frequency of referral to radiography     could be reduced.   "
113917|NCT01794806|"     The purpose of this study is to clinically and radiographically assess whether the use of a     ridge preservation technique significantly minimizes alveolar ridge resorption following     tooth extraction.   "
113918|NCT01794793|"     The purpose of this study is to allow continued use of pasireotide in patients who are on     pasireotide treatment in a Novartis-sponsored, Oncology Clinical Development & Medical     Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.   "
113919|NCT01794780|"     This multi-center study is designed to describe natural history of disease, treatment and     health care products in physician-diagnosed COPD patients who require adding daily     maintenance therapy in real world.   "
113925|NCT01794702|"     The goal of Phase I of this clinical research study is find the highest tolerable dose of     clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with     acute leukemia.      The goal of Phase II of this study is to learn if decitabine followed by the combination of     clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of     this drug combination will also be studied.      Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells).     This may cause cancer cells to die.      Clofarabine is designed to interfere with the growth and development of cancer cells.      Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.   "
113926|NCT01794689|"     Twenty percent of Americans suffer from chronic pain. Sleep disturbance is similarly     prevalent and among the most common and disabling neurobehavioral problems associated with     chronic pain. This research is designed to evaluate the effects of disrupted sleep patterns     on mood, inflammation, the perception of pain, and pain relief. This study will help     researchers understand the relationship between sleep and pain, and how sleep disturbance     might influence chronic pain conditions.   "
113927|NCT01794676|"     This study is being conducted to identify altered genetic factors that may exist and     influence endocrine cancers in unrelated MEN1 families with different cancers. A grading     system will be developed for endocrine cancers, including pancreatic cancers, thymus gland     cancers, parathyroid disease and MEN1 syndrome as low-risk and high-risk to improve screening     and timing of surgery.   "
113928|NCT01794663|"     When a patient receives a kidney transplant particularly if the kidney is from an older donor     or one who has had the kidney removed after their heart has stopped, there is a risk that the     newly transplanted kidney may not function immediately. If the delay in function means that     dialysis is needed in the first 7 days after the transplantation then this is known as     delayed graft function or dDGF. Also delayed graft function that does not require dialysis     but is present because the serum creatinine does not fall sufficiently is known as functional     delayed graft function or fDGF. This problem is often due to an excessive inflammatory     reaction to not having had a blood supply between the time of donation and transplant.      OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be     partly responsible for increasing the risk of this inflammation. It is hoped that the effects     of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring.      The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF     as well as improving other measures of kidney function and the overall safety of the     antibody. In the first part of the study, each patient received an Infusion of one of three     possible doses of OPN-305 or a placebo and in the second part the most suitable dose of     OPN-305 and a placebo would be used. The purpose of this second part of the study is to find     out if a dose of OPN-305 which has already been tested in an earlier part of this study can     prevent kidney graft dysfunction. For the purposes of this study, kidney function will be     assessed using the composite of delayed graft function (dDGF) because dialysis is necessary     in the first 7 days and functional delayed graft function that does not require dialysis but     is present because the serum creatinine, a key measure of renal function, does not fall     sufficiently (fDGF) in the first 7 days post-transplant.      Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft     function of patients who have completed the 6-month post-transplant period under Part A or     Part B of OPN305-102.   "
113929|NCT01794650|"     The investigators hypothesise that manipulating the glycaemic index of the meal after     exercise and before sleep will help prevent Type 1 diabetes individuals experiencing     hypoglycaemia.   "
113930|NCT01794637|"     End - stage liver disease can cause many problems to the patients including fatigue,     weakness,jaundice, confusion, abdominal pain and distension. Another important problem is the     cardiovascular system (heart and blood vessels). There will be the impairment of heart     function to pump blood to the distal part of the body. Blood vessels are also affected by the     imbalance of chemical agents which are not detoxified by diseased liver, resulting in     impairment of oxygen carrying capacity and tissue oxygen exchange. Mechanism of this process     is still poorly understood.      This is a study about the peripheral vascular dysfunction by means of vascular occlusion test     (VOT). Blood pressure cuff is inflated (to occlude the proximal vessels and induce distal     part ischemia), then deflated and observing the distal tissue oxygenation (StO2)change by the     probe (Near-infrared spectroscopy : NIRS) at the hand. From our knowledge, there is no study     in patients undergoing liver transplantation.      The study investigator would like to observe the change in peripheral tissue oxygenation in     different time points during the liver transplantation. We hypothesize that there is a change     in microcirculatory function and StO2 in end-stage liver disease patients detected by VOT and     NIRS.   "
113931|NCT01794624|"     TMD is a poorly understood chronic pain disorder that affects up to 15% of the adult     population, notably impacting women, is linked to greater healthcare utilization, and     associated with multiple pain-related co-morbidities. Pain-related catastrophizing (CAT) and     sleep continuity disturbance (SCD) are well established modifiable risk factors for TMD and     other idiopathic pain conditions. Neither the causal status nor the neurobiological     mechanisms by which these factors exert their effects on clinical pain have been established.     We propose that CAT and SCD influence clinical pain through shared alterations in pain     modulation and key neurobiological pathways, including amplified inflammatory activity,     autonomic activity, and adrenocortical functioning. Beyond these shared mechanisms, however,     we propose to determine whether pre-sleep CAT increases cortical arousal during sleep. The     cognitive dimensions of pre-sleep arousal, particularly rumination and negative sleep-related     thoughts, are central to the phenomenology of insomnia. Extending this notion, we propose     that CAT in those experiencing ongoing clinical pain fosters sleep disturbance owing to     increased pre- and peri-sleep cognitive arousal. Moreover, we propose that pre-sleep CAT is     related to subtle variations in objective indices of fragmented sleep (e.g., cortical     arousal). We will examine key hypotheses derived from this framework using a brief,     prospective randomized experiment, which will permit careful analysis of the temporal     patterning of how changes in either CAT or SCD influence each other and contribute to     alterations in pain modulatory systems, key nociceptive mechanisms, and clinical pain.      Women experiencing at least moderate chronic TMD pain (N=225) who demonstrate at least mild     trait catastrophizing and meet at least subclinical insomnia criteria (SCD) will be randomly     assigned to: 1) cognitive therapy for catastrophizing (CT-CAT); 2) behavior therapy for sleep     disturbance (BT-SCD); or 3) TMD education (Control). Assessments of clinical pain, sleep     disturbance, catastrophizing, pain sensitivity and modulatory systems, and indices of     inflammatory activity, adrenocortical function and autonomic balance will be completed at     baseline, 4 weeks (mid-manipulation) and 8 weeks (post-manipulation). Clinical pain, sleep,     catastrophizing and covariates will additionally be measured at 16 weeks (follow-up).   "
113932|NCT01794611|"     C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is     used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes     (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider     and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and     Macintosh laryngoscope during routine intubation in adult patients.   "
113943|NCT01794468|"     Background: Conditions of reduced perfusion are characterized by redistribution of blood flow     away from the skin to more vital organs.      Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor     in detecting changes in perfusion in critically ill patients.      Preliminary Study      Study Population: critically ill patients in a general ICU   "
113969|NCT01794130|"     The aim of this investigation is to determine the incidence of silent interstitial pulmonary     edema by chest ultrasound at moderate altitude (3905m). Secondary endpoints are to detect a     suspected association with acute mountain sickness (AMS), co-morbidities and endothelial     dysfunction (marker of hypoxia responses, endothelial damage and inflammation).   "
113933|NCT01794598|"     Purpose of the Study: The significant impact of depression on the poor prognosis and     functional restrain, recognition and successful treatment of depression in patients with     Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients.     However, depression comorbid with CHF has been overlooked in the real practice. Therefore,     the investigators are proposing a study to 1) assess the prognostic impact of depression in     patients with stable CHF who have been managed as outpatients, and 2) assess whether     provision of depression education to CHF patients will improve the care of depression.      Patients with chronic heart failure are enrolled into this study with a half of them are     randomly assigned to receive a packet of depression education materials and then other half     not. Participants and investigators both are blinded to the assignment. All the participants     are provided a toll free phone number to contact the research team as needed. Depressive     symptoms and patients knowledge of depression are assessed at baseline prior to randomization     and at 1-month and 6-month following the enrollment.      Responses of the study participants, such as change of depressive symptoms, and requests for     psychiatric help are examined between two groups.   "
113934|NCT01794585|"     The purpose of this study is to evaluate the effectivenes of a home-based physical therapy     program designed to improve balance following traumatic brain injury by incorporating the use     of a virtual reality system.   "
113935|NCT01794572|"     In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow     (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome     inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem     Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to     healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern     irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a     Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ     at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the     conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose     escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting     Toxicities (DLT). An extended cohort will further in a phase-2 setting.   "
113936|NCT01794559|"     This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate     the effectiveness of PEER Interactive to inform treatment in subjects with a primary     diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus     treatment as usual, as determined by the investigator. The primary measurement for     improvement of the subjects depression will be a self-evaluation questionnaire, Quick     Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also     collect information on their clinical global improvement and any reduction in adverse events.   "
113937|NCT01794546|"     Obesity is perhaps the most urgent public health crisis in pediatrics. Thus, managing     childhood obesity is a top priority among pediatricians in primary care settings. However,     effective treatment typically is multidisciplinary, and most practices currently do not have     the infrastructure for coordinating integrated care. With the advent of the Affordable Care     Act (ACA), innovative systems for building multidisciplinary teams to provide integrated care     through a patient-centered medical home will be at a strategic advantage. The use of     electronic technologies for delivering health-related information or services, known as     telehealth, is an innovation with the potential to streamline integrated care and transform     interventions for chronic diseases. We propose a pilot study to evaluate telehealth for     treating pediatric obesity in collaboration with a community practice (Wareham Pediatrics).      Patients aged 10 to 17 years who participate in the telehealth intervention study (N=40) will     be randomly assigned to an immediate intervention group or a wait list control group.     Subjects in the immediate intervention group will begin the 6-month telehealth intervention     at the time of enrollment in the study and then receive general patient/family counseling     from their primary care providers (PCPs) at routine office visits during a 6-month follow-up     period. Those in the wait list control group will receive general patient/family counseling     from their PCPs for 6 months followed by the telehealth intervention for 6 months. Thus, the     total duration of participation in the study for each subject will be 12 months. The     telehealth intervention will include dietary, physical activity, and behavioral management     counseling provided by videoconferencing from the OWL clinical providers at Boston Children's     Hospital to children in their homes, or at a telehealth station at Wareham Pediatrics.   "
113938|NCT01794533|"     Achievement of a deep and long-durated anesthesia is vital before most endodontic procedures;     therefore, the investigators conducted this study to compare the local infiltration effect of     epinephrine-containing lidocaine with/ without fentanyl on depth and duration of anesthesia     in maxillary molars with painful irreversible pulpitis.   "
113939|NCT01794520|"     The primary objectives of this study are to assess the safety profile, characterize     pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and     recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in subjects with     relapsed or refractory multiple myeloma. This study will also assess the safety profile and     PK of venetoclax in combination with dexamethasone in subjects with t(11;14)-positive     multiple myeloma.   "
113940|NCT01794507|"     The primary objectives of this study are to assess the safety profile, characterize     pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and     the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed     /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard     therapy.   "
113941|NCT01794494|"     Severe atherosclerosis in the leg arteries is termed critical limb ischemia (CLI). This     condition gives great suffering for the patients in terms of pain, wounds and often     developing gangrene. Untreated, the condition has a high risk of amputation. In Sweden, the     majority of the patients are investigated and evaluated for treatment. Treatment is carried     out either by traditional open bypass surgery or balloon dilatation technology (endovascular     treatment). The latter method is still under development, and studies have shown that the     treatment has less local and systemic complications than bypass surgery. It is also shown     that the method has a limitation in that the treatment effect is less durable. What is the     role of minimally invasive technologies should have in the future is unclear, mainly due to     its efficiency and cost-effectiveness compared with bypass surgery are not evaluated. In a     prospective observational study we intend study the effectiveness, cost-effectiveness and     impact on quality of life in patients undergoing treatment for critical CLI with bypass     surgery or endovascular treatment in Västra Götaland Region (VGR). All patients over a period     of two years, which undergo treatment for CLI with either of the two methods will be included     in the study. Patients will be followed up with regard to the clinical efficacy and life     qualifying small after treatment at, respectively one, 12 and 24 months. Cumulative care     costs are calculated and estimates of cost are made. This study aims to increase knowledge     about the role of endovascular treatment of CLI shall have in the future.   "
113944|NCT01794455|"     This pilot proposal will test the hypothesis that altered cerebral vessel reactivity and     cerebral hypoperfusion (decreased blood flow to the brain) is a core mechanism underlying the     relationship between vascular disease and depression in older adults. The long-term objective     of this line of research is to: A) determine the relationship between vascular reactivity,     cerebral hypoperfusion and the persistence of late-life depression and B) determine if     improving cerebral perfusion with angiotensin receptor blockers (ARBs) improves depression     outcomes.   "
113945|NCT01794442|"     Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent     findings have confirmed that there is a direct correlation between the levels of venous     oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in     retinal cell metabolism.      However, glaucoma patients have been suggested to have a different pattern in retinal venous     circulation. For instance, the observation of a visible pulsating central retinal vein is a     phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in     less than 50% of glaucoma patients. While the nature of these venous changes are not year     clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous     pressure due to some obstruction from both ocular or extraocular structures. This     undetermined increase in venous pulse pressure could then significantly decrease perfusion     pressures and therefore further decrease oxygen supply to the retinal tissues.      The investigators will therefore try to determine if there is a significant difference     between the oxygen saturation of the retinal vessels in both glaucoma patients with and     without a visible pulsating central vein   "
113946|NCT01794429|"     To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can     induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic     spectrum.      The investigators will also examine possible associations between GLP-1 treatment and     peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1     analogue treatment will be associated with the effects/changes on cognition and subjective     quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment     will associated and correlated with changes in the brain, functional magnetic resonance     imaging (fMRI).   "
113947|NCT01794416|"     The investigators aimed to compare two approaches thoracoscopic epicardial ablation and     endocardial catheter ablation after failed initial catheter ablation in patients with     paroxysmal atrial fibrillation.   "
113949|NCT01794390|"     Randomised, cross sectional, observational study evaluating inhaler device critical errors     (errors that could affect dose delivery to the lungs) for the Pulmojet inhaler compared to     Diskus or Turbuhaler in asthma and COPD patients receiving regular maintenance inhaled     steroid therapy.   "
113950|NCT01794377|"     The purpose of this study is to evaluate the efficacy of 2 physical exercise training     programs, with a supplementation in fruits and vegetables, on energy cost of walking. 60     subjects will be randomized into 2 groups. The first program will be consist of an interval     strength training for 30 min on bicycle ergometer (which include strengthening exercises in     an high intensity interval training). The second program will be conducted at a relatively     low intensity of effort, corresponding to 50% of oxygen uptake (VO2) peak measured by     indirect calorimetry. All subjects will receive a free supplement of 5 fruits and vegetables     per day during all the intervention. The intervention will last 9 months in total : 5 month     at the hospital fallow by 4 month at home.   "
113951|NCT01794364|"     The primary purpose of this trial is to evaluate the safety and tolerability,     pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy     volunteers.   "
113952|NCT01794351|"     This study investigated the potentially cognitive enhancing effects of 500mg     trans-resveratrol in healthy, young humans.   "
113953|NCT01794338|"     This study evaluates the outcomes of patients who have been treated with Strattice or Gore     Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is     to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh     has been shown to provide durable long-term outcomes; however, this type of mesh should not     be used in patients at risk of developing an infection. Therefore, to address the challenge     of finding an artificial strengthening material to repair complicated hernias in patients     that could potentially develop surgical infection, two types of non-permanent materials have     been developed, including biologics and bioabsorbables. Biologic mesh is made of living     tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the     body over time. The purpose of this study is to allow surgeons to compare the postoperative     course of patients associated with these two mesh types to decide which material will improve     the outcomes of their patients with complicated abdominal wall defects. To date there is no     evidence to suggest that either mesh type is superior or safer than the other.   "
113954|NCT01794325|"     Transradial approach (TRA) reduces vascular complications and access related-bleeding     compared to transfemoral approach (TFA). However, this technique has been related to higher     radiation exposure during coronary angiography and percutaneous coronary intervention.     Previous studies have shown that TRA demands a long learning curve, and procedure success     rate increases with operator's experience. Our hypothesis is that the higher radiation     exposure during TRA is not a technique issue, but due to operator's expertise.      The aim of this study is to evaluate whether experienced operators with either TRA or TFA can     perform diagnostic coronary angiography with similar radiation exposure.   "
113955|NCT01794312|"     The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.   "
113956|NCT01794299|"     The purpose of this study is to determine whether ATIR is safe and effective in reducing     transplant-related mortality and improving overall survival, when infused in patients with a     hematologic malignancy following a T-cell depleted stem cell graft from a related     haploidentical donor.   "
114006|NCT01793649|"     This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether     GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared     to vehicle of 2.8% saline alone.   "
114188|NCT01791231|"     The purpose of this study is to investigate the absorption (the way the drug enters the     body), metabolism (the way the drug is broken down in the body), and excretion (the way drug     leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single     dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of     canagliflozin will also be assessed.   "
113957|NCT01794286|"     Specific Aim: To improve childhood immunization rates by utilizing automated Electronic     Health Record-derived provider-specific performance feedback reports, coupled with automated     Electronic Health Record-derived trigger alerts.      Hypothesis: The automated Electronic Health Record-derived provider-specific performance     feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of     age, when coupled with automated Electronic Health Record-derived trigger alerts, compared     with trigger alerts alone.   "
113958|NCT01794273|"     The effects on brain perfusion of the two currently vasopressors used to treat accidental     hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known,     but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and     according to published reports   "
113959|NCT01794260|"     The objectives of this study are to assess short term efficacy and safety of of topical     preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering     from osteoarthritic pain   "
113960|NCT01794247|"     5% hyperbaric lidocaine has lost its usefulness for same-day-surgery (SDS) anaesthesia     because it has been blamed responsible for the so-called transitory neurological syndrome     (TNS). This entity appears particularly in patients operated on lithotomy and knee     arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out of     10) and self-limited in time, but disturbing enough to be avoided in same-day-surgery cases.     Other local anesthetics are not competitive with general anesthesia in time to be discharged     home from the SDS unit. The magnesium ion is well-known for its protective properties on     cells with electrical activity. The objective is to confirm that the magnesium ion added as     adjuvant to intrathecal (IT) lidocaine may antagonize TNS incidence. If this hypothesis could     be confirmed, the practical and theoretical consequences would be far-reaching.      The method to achieve our objective would be a double-blinded randomized clinical trial     considering two groups of intrathecal lidocaine: with and without added IT magnesium.   "
113961|NCT01794234|"     This observational study will evaluate the efficacy and safety of Pegasys (peginterferon     alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with     nucleoside (nucleotide) analogues. Data will be collected from patients treated according to     the current Summary of Product Characteristics and local standard of care and regulations     during 48 weeks of treatment and 24 weeks of follow-up.   "
113962|NCT01794221|"     The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive     decreased the incidence of recurrent adhesions after circumcision. The investigators     hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl     cyanoacrylate skin adhesive.   "
113963|NCT01794208|"     The aim of the current study is the determination of the recommended standard treatment dose     of FSH-GEX(TM) in women undergoing ICSI (intracytoplasmic sperm injection) treatment as     assessed by follicle growth.   "
113964|NCT01794195|"     Use lay language.      Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of     Parkinson's disease. Depending on methodological approach of the study, its prevalence is     estimated to be between 16 and 51%.      Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which     seems to play a central role in the control of mood and motivation. The subcortical     components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and     the constituents of the limbic system (particularly the hippocampus and amygdala), all of     which are located deep inside the brain (18). The hypothesis is that depletion of striatal     dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical     circuits results in hypofunction of these circuits and the loss of frontal cortical activity,     particularly within in the frontal orbital cortex, the anterior cingulate cortex and the     prefrontal cortex      The objective of this study is to explore, using diffusion weighted MRI, the regions of the     brain which are proposed to play a role in motivation in apathetic Parkinson's disease     patients and to define more precisely the relation between dopaminergic fibres and the     meso-cortico-limbic system with the help of tractography methods   "
113965|NCT01794182|"     This is a randomized, multi-center, prospective, double blind study. The primary objective is     to demonstrate the efficacy of RP-1127 compared to placebo in subjects with a severe anterior     circulation ischemic stroke who are likely to develop malignant edema. This objective will be     addressed by comparing the proportion of RP-1127 treated patients and placebo treated     patients with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy     (DC).   "
113966|NCT01794169|"     The purpose of this study is to determine whether Azacitidine consolidation is superior to     standard DA consolidation treatment of acute myeloid leukemia in first complete remission in     elderly patients.   "
113967|NCT01794156|"     Obsessional compulsive disorder (OCD) is a very debilitating psychiatric problem which     affects around one million Canadians and their families. Obsessions are intense     preoccupations about bad, harmful, dangerous, shocking or unlucky events which 'may' occur     and which drive sufferers to perform time consuming and distressing compulsive rituals to     prevent the possible event occurring. The current psychological treatment of choice is     cognitive behavior (CBT) therapy which focuses on treating OCD by reducing obsessional     anxiety about the likelihood and the consequences of the preoccupying event. A rival     cognitive model termed the inference-based therapy (IBT), developed by the principal     investigator and co-workers, considers that the OCD begins with the initial doubting     inference 'maybe something is wrong' and focuses on changing the reasoning behind this     doubting inference which often trumps the common sense conviction that there is no reason to     doubt. This clinical trial randomly allocates participants to either IBT or CBT treatment     condition or to a third generic mindfulness condition. The latter condition is a non-specific     meditational-based training which has shown evidence of reducing stress and anxiety across a     number of psychiatric problems including OCD. Two hundred and forty people will be recruited     over a 5-year period from two principal sites (Montreal and Gatineau/Ottawa) with which the     principal investigator and co-investigators have clinical links. Therapy will be administered     by trained professionals following a treatment manual specific to each approach. The therapy     will last a maximum of six months or until the point when the person achieves a non-clinical     status. The patients will be assessed pre, post, and at six months following treatment on     standard evaluation instruments as well as on subjective measures. We expect the IBT to be     superior in terms of number of participants responding to treatment, rapidity of improvement     and gains at follow-up.   "
113968|NCT01794143|"     The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used     diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and     patient-centered outcomes.   "
114299|NCT01789775|"     Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema     associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once     daily is more efficacious than vehicle and provides an acceptable safety profile in the     treatment of facial erythema associated with rosacea   "
113970|NCT01794117|"     Background:        -  Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the          immune system attacks the body s tissues. These diseases cause painful and itchy skin          rashes, eye and mouth irritation, joint pain and fever. Several drugs for treating these          diseases suppress the immune system. However, they can cause severe side effects when          taken over a long period of time.        -  IL-1 is a small protein that may be important in causing the inflammation seen in          pustular skin disease. Anakinra is a drug that works by blocking IL-1. It has been          effective in treating some inflammatory conditions such as rheumatoid arthritis.          However, anakinra has not been studied for use in patients with pustular skin disease.          Researchers want to see whether anakinra will be effective in treating pustular skin          disease.      Objectives:      - To see if anakinra can be used to treat inflammatory pustular skin disease.      Eligibility:      - Individuals at least 18 years of age who have inflammatory pustular skin disease.      Design:        -  Participants will be screened with a physical exam and medical history. Their disease          will be evaluated with blood tests, urine tests and imaging studies. Skin biopsies may          also be collected.        -  Participants will have an initial visit to receive the first dose of anakinra. They will          be shown how to give themselves daily injections of anakinra.        -  Participants will take anakinra for up to 12 weeks as long as there are no severe side          effects. During this time, they will keep a study diary to record the severity of any          rashes, pustules, itching, fevers, and skin or joint pain. They will bring this diary to          their study visits.        -  Participants will have study visits at weeks 4, 8 and 12. Treatment will be monitored at          these visits with blood tests, urine tests and physical exams. Depending on the effects          of the treatment, participants may have the dose of anakinra increased or decreased.        -  Participants will have a final study visit 4 weeks after they stop taking anakinra.   "
113971|NCT01794104|"     Background:      - Indenoisoquinoline LMP400 is an experimental cancer treatment drug. It damages DNA in tumor     cells. Tumor cells with damaged DNA may die, resulting in cell death. Researchers want to see     if this drug is a safe and effective treatment for solid tumors and lymphomas that have not     responded to earlier treatment.      Objectives:      - To see if Indenoisoquinoline LMP400 is a safe and effective treatment for advanced solid     tumors or lymphomas.      Eligibility:      - Individuals at least 18 years of age who have solid tumors or lymphomas that have not     responded to treatment.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Tumor samples may also be collected. The size and location of          the tumors will be determined with imaging studies.        -  Indenoisoquinoline LMP400 is given in a 28-day cycle. Participants will receive the drug          by intravenous infusion on days 1, 8, and 15 of each cycle, followed by a break of 13          days without the drug.        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples          will be optional.        -  Participants will continue their cycles of treatment as long as the cancer does not grow          and there are no severe side effects.   "
113972|NCT01794091|"     People with diabetes are at an increased risk of heart attacks and heart failure, and it is     important to be able to treat people with diabetes who are at risk for heart disease to     prevent these outcomes. This study is looking at the importance of diffuse scar tissue that     is found in the heart of diabetic people. We have discovered a way to detect diffuse scar     tissue by cardiac MRI, a non-invasive test. In this study, we do cardiac MRI on diabetics     with low risk stress test results and follow them for 5 years to see if the measure of scar     tissue in the heart by MRI is related to events. If this study is positive, we will be able     to use cardiac MRI scar tissue measurements to target those patients with diabetes who are at     highest risk.   "
113973|NCT01794078|"     Acute exposure of the unacclimatized human body to high altitude leads to health     complications, such as loss of exercise performance capacity and fatigue. The investigators     have found that the combination of the xanthine drug theophylline and the endothelin receptor     antagonist ambrisentan improves the exercise performance capacity of rats under simulated     high altitude. In young, healthy human volunteers, this combination of drugs has not increase     toxicity over the single compounds under sea-level conditions. The aim of this study is to     test whether the combination of theophylline, supplied as its more soluble formulation     aminophylline, and ambrisentan, are also safe to take under simulated high altitude of 4,267     meters, under both resting and exercising conditions. The study also aims to test whether     this drug combination improves exercise capacity in humans. In this study, human subjects     will be randomized to one of four treatment sequences and receive the same study drug(s)     throughout all procedures. The study consists of an initial exercise test, followed by two     cycles of drug testing at simulated high altitude: Cycle 1 - resting subjects receiving study     drug at simulated altitude and continually monitored for safety with pharmacodynamic and     pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with the addition of exercise     testing. It is hypothesized that the combination of aminophylline and ambrisentan is not only     safe under simulated high altitude, but also improves exercise performance capacity, in     comparison with placebo.   "
113974|NCT01794065|"     This study is being done to study stent deformation on persons with de novo coronary lesions     to determine how much deformation takes place and how often. The information gathered from     the group that receives the Promus element stent will be compared to other groups that     receive other contemporary drug eluting stents.   "
113975|NCT01794052|"     Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these     two conditions can be detected much early in life and are amenable to interventions at     primary health care level, the health system in India fails to provide adequate interventions     at primary health care level which translates to huge burden of undiagnosed and uncontrolled     hypertension and diabetes in the community. This study aims to design a feasible and     sustainable evidence-based, decision support-enabled, health care delivery model for the     management of hypertension and diabetes in the primary health care facilities of Himachal     Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District     Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods.     The design and development of the model will be carried out in the initial six months     followed by piloting the services at the CHCs and District Hospital. The impact of the model     on quality of care will be assessed in a pre-post design measuring changes in both clinical     and process indicators.   "
113976|NCT01794039|"     This randomized phase II trial studies how well pomalidomide and dexamethasone work compared     to lenalidomide and dexamethasone in treating patients with multiple myeloma that has     returned after a period of improvement (relapsed) or did not respond to previous treatment     with lenalidomide (refractory). Pomalidomide and lenalidomide may help the immune system kill     cancer cells and may also prevent the growth of new blood vessels that tumors need to grow.     Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Dexamethasone may also help pomalidomide and lenalidomide work better by     making cancer cells more sensitive to the drugs. It is not yet known whether pomalidomide and     dexamethasone or lenalidomide and dexamethasone are effective in treating patients with     relapsed or refractory multiple myeloma.   "
113977|NCT01794026|"     Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced     disease stateS for the patients in which the surgery may be unnecessary to perform. Although     there are many imaging techniques for this purpose, sensitivity and specificity of these     techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and     involvement of lymph nodes beyond D2 may prevent surgical procedures.      Removal of the determined lymph nodes according to the type of the surgery is the accepted     surgical method. However, accurate determination of malignant lymph nodes may prevent     dissection of some groups of the lymph nodes. These findings may cause a new definition of     gastric lymph node dissection.   "
113978|NCT01794013|"     The objective of this study is to test whether adding the parent training program using the     relationship-based approach could help the children with development disabilities (DDs) would     confer additional benefits over routine clinical care available to both groups in terms of     improving their development and reducing behavior problems.   "
113979|NCT01794000|"     The main purpose of the study is to evaluate the efficacy and safety of the study drug known     as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with     sickle cell disease. The study will also investigate reduction in daily pain in children who     have sickle cell disease.   "
113980|NCT01793987|"     Chronic Rhinosinusitis (CRS) refers to a pathological condition where the sinonasal mucosa is     inflamed for greater than 12 weeks(1). It is associated with a constellation of symptoms,     including facial pain, anosmia, and nasal congestion. It has been estimated that CRS affects     close to 5% of the Canadian population(2). When medical therapy fails, patients are often     referred to Otolaryngology- Head and Neck Surgeons for consideration of surgical management.     Endoscopic sinus surgery (ESS) is one of the mainstays of therapy for CRS that has failed     medical management(3). Traditionally, the microdebrider has been the go-to tool for     performing these surgeries, but recently the Coblator (ArthroCare, Austin, Texas) has begun     to define its' role in surgery. By using bipolar radiofrequency energy to ablate tissue (with     temperatures up to 60˚ C)(4), theoretically the Coblator will result in less bleeding than     so-called cold surgical techniques (i.e. the microdebrider). In a retrospective study by     Eloy et. al, patients with CRS and nasal polyposis had a statistically significant amount of     less intraoperative blood loss when the Coblator was used in their surgery, than those     patients who underwent surgery with the microdebrider. The investigators plan to further     investigate this in a randomized, controlled fashion   "
113981|NCT01793974|"     This is a prospective study that will study adults and has the objective of examining 'Latent     Autoimmune Diabetes in Adults' (LADA) to understand how this trait is influenced by genetic     factors.   "
113982|NCT01793961|"     Rates of driving under the influence of cannabis have risen in recent years. Cannabis is     involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect     dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast     sensitivity disorders could originate difficulties to anticipate and avoid collision with     objects, especially when objects are in movement. The investigators goal is to examine the     effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be     compared to standard references. In addition, since smoking cannabis is always associated     with tobacco, the investigators will control the effects of tobacco on contrast sensitivity.      In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36     no smokers. The investigators will present gratings with different spatial frequencies and     the investigators will determine contrast thresholds for static and dynamic (moving)     gratings. The investigators predict that cannabis addicts will present abnormal contrast     sensitivity especially in case of dynamic presentation of gradings.   "
113983|NCT01793948|"     This randomized clinical trial studies metformin hydrochloride in overweight or obese     patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the     expression of early tumor makers in breast tissue of patients at increased risk for breast     cancer   "
113984|NCT01793935|"     Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or     to build resistance to stress or diseases in indigenous medical systems in India for     centuries. Modern scientific data for WSE indicate several bioactive molecules (withanolides,     withanosides, indosides, withaferin-A, others) with significant immunomodulatory,     anti-inflammatory and stress reducing properties.      This study will examine whether a standardized extract of Withania Somnifera (WSE; Sensoril®)     will improve total, positive, negative symptoms, and stress in patients with schizophrenia.     The study will examine whether WSE reduces PANSS positive and negative symptoms and stress     scores in subjects, and whether these improvements are mediated by changes in inflammatory     immune indices. An additional aim will determine if patients receiving WSE will have fewer     adjustments to their psychotropic medications that those assigned to placebo. The study will     examine whether WSE will re-balance Th1/Th2 ratios (cytokine measures) and mediate a     reduction of elevated hs-CRP levels. It is hypothesized that those subjects whose Th1/Th2     ratios normalize will likely have a greater magnitude of clinical improvement versus those     subjects whose immune ratios remain unbalanced.      The proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to antipsychotic     medications in approximately 60 or more patients with schizophrenia with an exacerbation of     symptoms. If efficacy is affirmed, this low cost extract could be studied further, and used     quite readily across low, middle and high income countries.   "
113985|NCT01793922|"     The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the     efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It     is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment of     therapy-naive patients with idiopathic achalasia.   "
118404|NCT01736150|"     The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum     phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on     dialysis.   "
114098|NCT01792427|"     In this study we analyzed the overall survival for all newly diagnosed patients with     non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to     confirm the known risk factors such as age, gender, smoking history and Pseudomonas     aeruginosa and evaluate the impact on survival of etiology, number of different     bacteriological species in retrospective and prospective sputa, azithromycin use and     presence/development of pulmonary hypertension.   "
113987|NCT01793896|"     Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects,     which retard or prevent age-related diseases and prolong life span. Subjects with the     metabolic syndrome age prematurely, therefore preventive measures should be initiated early.     The present study intends to demonstrate that physical exercise and/or Mediterranean diet, in     middle aged volunteers with the metabolic syndrome, preserve adequate adipose tissue     functionality and retard skeletal muscle aging (assessed by mitochondrial biogenesis and     accumulation of ROS), by activating several pathways, homologous to CR. The investigators     plan to study this by using two approaches: 1) A cross- sectional model, in which the     expression of the mentioned metabolic mediators, indicators of muscle mitochondrial     biogenesis and muscle oxidative damage will be compared between men with different body     compositions, fat distribution, muscle strength and exercise capacity (VO2max). Also, in     these men the investigators will assess the expression of uncoupling protein 1 (UCP1) in     subcutaneous white adipose tissue (as a measure of adaptive thermogenesis), and inflammatory     markers (Interleukin 1-6, Interleukin 1ß and CCL2 chemokine (C-C motif ligand 2)) in     preperitoneal adipose tissue, plus inflammation and adipogenesis potential of their cultured     preadipocytes. Moreover, in vitro studies will evaluate the functional effects of exposure of     a cell lyne of human adipocyte cells (LS14)to factors secreted by media conditioned by the     patients´ adipose tissue explants. 2) A prospective intervention in overweight/moderately     obese middle aged volunteers that will be assigned to a weight-maintenance period (as a     control group), and then randomly y assigned to a Mediterranean diet, exercise training or     diet plus training. Before and after 3 months of intervention the investigators will obtain     muscle tissue samples to study the expression of Peroxisome proliferator activated receptor     (PPAR) gamma coactivator 1 alpha (PGC1), uncoupling protein 3 (UCP3), AMP activated protein     kinase (AMPK), Sirtuin 1 (SIRT-1), mitochondrial DNA and oxidative damage indicators     (8-oxo-7,8-dihydro-2-deoxyguanosine (oxodG), carboxymethyllysine (CML and its receptor     (RAGE)). In vitro studies will evaluate the effect of circulating factors from the patients     (serum) on LS14 inflammatory and adipogenic potential, at baseline and after 3 months of     intervention.   "
113989|NCT01793870|"     This will be a randomized, open-label, single dose, 4-period, period balanced, crossover     study. There will be at least 5 days between dosing in each session. The study consists of     Screening period (30 days prior to Day 1), Treatment period consisting of 4 dosing periods     (Day 1 is the dosing day and Day 2) and Follow-up period (7-14 days post-last dose).      The detailed treatment regimen will be A and B (27.5 mg total maximum dose): Single oral dose     of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol powder     under fasted conditions; C (33.75 mg total maximum dose): Single oral dose of carvedilol     31.25 mg as 25 mg immediate release tablet, a 6.25 mg immediate release tablet and up to 2.5     mg of enriched carvedilol powder under fasted conditions; D (27.5 mg total maximum dose):     Single oral dose of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched     carvedilol powder under fed conditions. Approximately 15 subjects will be randomized to     receive one of four treatment sequences (ADBC, BACD, CBDA, or DCAB).      The pharmacokinetic sampling and safety data will be collected in the Treatment period (Day 1     and 2).   "
113990|NCT01793857|"     The study is a survey aiming to describe the healthcare seeking behaviour of primary     caregivers when their child aged 6 months to less than 30 months was suspected to have an     episode of acute otitis media in Panama.   "
113991|NCT01793844|"     This is a prospective , open, multicenter, randomized phase Ⅲ study. The investigators planed     to include 732 untreated CD20 positive diffused large B cell lymphoma adults,to random to     R-CHOP21, CHOP14 , R-CHOP14 regimen groups after signature the informed consents. The     patients will receive safety assessment every cycles, and efficacy evaluation every 2 cycles.     Every-two-months follow up will be received after finishing the treatment.   "
113992|NCT01793831|"     The gut microbiota is considered to constitute a microbial organ which has pivotal roles in     the intestinal diseases and body's metabolism. Evidence from animal and human studies     strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD).     Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis.     Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable     bowel syndrome (IBS) and constipation have also met with some success. However, the results     on CD is very limited. This is an initial step into investigating the potential efficacy of     fecal bacteriotherapy for CD, the investigators propose to determine the efficiency,     durability and safety of FMT in a series of 30 patients with CD (included cased according     Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3 but without     perianal diseases).   "
113993|NCT01793818|"     Tat Oyi vaccination on seropositive patients could help their immune system to recognize and     neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune     response to eliminate HIV-1 infected cells.   "
113994|NCT01793805|"     This is a study to collect and analyze tissue specimens from metastatic colorectal cancer     (mCRC) patients for the development of a molecularly profiled tissue repository for the     primary purpose of maintaining a patient registry for future clinical trials based on the     molecular profile of the tumors. The main purpose of testing these tissue specimens is to     identify genetic alterations or biomarkers associated with colorectal cancer such that if new     agent(s) become available, particularly those that target these genetic     alterations/biomarkers, participants may be offered the opportunity to take part in a     National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.   "
113995|NCT01793792|"     The purpose of this study is to evaluate the safety and efficacy of the Low Profile     Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used     to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.   "
113996|NCT01793779|"     Study Objectives        1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on          performance recovery from an acute bout of high intensity resistance exercise.        2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.        3. Examine the effect of these recovery modalities on markers of muscle damage,          inflammation and immune function.      Subjects      Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience     will be recruited. Subjects will be randomly divided into one of four groups: a cold water     immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).      Study Protocol      Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On     the first visit (T1) subjects will be tested for maximal strength [one repetition-maximum     (1-RM)] on the squat, dead lift and barbell lunge exercises.] On their second visit (T2)     subjects will perform a lower body resistance exercise session consisting of four sets of the     squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL     at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four     sets of the squat exercise only using the same loading pattern and rest interval length as     T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW     will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F     - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each     workout and CW+HMB-FA will be administered together at time points describe above.      Statistical Analysis      Statistical evaluation of performance and biochemical changes will be accomplished using a     repeated measures analysis of variance (ANOVA).   "
114099|NCT01792414|"     This study is a RCT of transcranial electrical stimulation in depressed patients. Mood,     cognitive test performance and biomarkers will be measured during the trial.   "
113997|NCT01793766|"     This is a study of overweight men and women. Everybody will receive a very low calorie diet     to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the     patients will receive an intervention to activate parts of their brain that can help them eat     less. The other half of the patient will receive a placebo or sham intervention. The     intervention will involve a small electric current given every day for 10 days. Everybody     will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to     see if the intervention helps people keep the weight off.   "
113998|NCT01793753|"     Background and Aim: An anorectal manometry (ARM) is a common test in the evaluation of outlet     obstruction in constipation. In children under 6 yo, anesthesia is often used for patient     comfort and compliance. The choice of anesthesia for ARM varies from center to center and     includes the use of ketamine, inhalation agents, and propofol. With the increased use of     propofol, our aim is to determine the effects of propofol on resting anal sphincter pressure     while performing an ARM under general anesthesia.      Hypothesis: Propofol administration leads to a decrease in internal anal sphincter pressure.      Methods: This is a prospective, single center, observational study of the effect of propofol     on the internal anal sphincter pressure. Pediatric patients between the ages of 2-6 years who     require an anorectal manometry for chronic constipation will be offered enrollment.     Anesthesia was required for patient compliance and comfort and conducted by an     anesthesiologist. Sevoflurane was the inhalational agent used for induction. At Massachusetts     General Hospital (MGH), 1 mg/kg of propofol bolus is routinely given at completion of the ARM     test to reduce emergence delirium. The manometric probe was kept in place with continuous     measurement of baseline internal anal sphincter pressure while propofol was administered. We     measured changes to internal anal sphincter pressure and time to return to baseline.      Results: The primary outcomes will be change of internal anal sphincter pressure from     baseline and time to return to baseline.      Discussion: The proposed investigation may demonstrate that propofol has an effect on the     internal anal sphincter pressure which may affect its utility as an anesthetic for anorectal     manometry.   "
113999|NCT01793740|"     The majority of school-age children with sickle cell disease (SCD) experience neurocognitive     deficits, even in the absence of stroke. In particular, deficits in attention and working     memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal     of the present proposal is to address feasibility and compliance of a novel computerized     cognitive training program, Cogmed. Pilot data will also be collected to establish     preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will     be identified and approached about participation by their attending physician during     regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of     intellectual functioning, a brief cognitive testing battery evaluating processing speed and     working memory, in addition to questionnaires regarding behavior and quality of life.     Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist     control (n=12). Participants enrolled in the computerized CT program will be asked to     complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).     Following completion of the program, children and their parents will be asked to return to     clinic for a follow-up visit. After a five to eight-week waiting period, children in the     waitlist condition will also be asked to return to clinic for a second visit. Following this     assessment, participants initially enrolled in the waitlist will be offered an opportunity to     participant in the intervention. If interested, they will follow the same intervention     protocol described above. These children will return to clinic for a third visit following     completion of the intervention. Compliance rate and its confidence interval will be     calculated for the overall study population. A t-test for binomial proportion with continuity     correction will be used to examine whether the compliance rate is lower than the target.     Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive     measures such as attention, executive functioning and working memory, that are most closely     related to the trained tasks).   "
114000|NCT01793727|"     A prospective trial evaluating the learning curve associated with the use of a     videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by     anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.   "
114001|NCT01793714|"     One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal     resection with the minimal neurological risk. The presurgical mapping of eloquent areas with     functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now     the gold standard to map language areas. However, BOLD signal is diminished near the brain     tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL)     techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL     could be interesting to detect eloquent areas near a brain tumor.   "
114002|NCT01793701|"     This will be the first study to assess the clinical feasibility of dose escalation with     simultaneous integrated boost intensity-modulated radiotherapy for patients with locally     advanced cervical cancer. Following screening to confirm eligibility patients will commence a     six week treatment period. After this, patients will be followed up by visits to clinic every     3 months for a period of 24 months (2 years). End of study is defined as 24 months after     treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after     treatment.   "
114003|NCT01793688|"     The purpose of the survey is to study the followings under practical use, regarding the     safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and     UNASYN-S KIT for intravenous use (UNASYN).        1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse          Drug Reaction)        2. Incidence status of adverse drug reactions        3. Factors that may affect the safety and effectiveness   "
114004|NCT01793675|"     Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative     treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%).     However, many patients cannot find an HLA-matched donor. haploidentical donor is an     alternative stem cell source.      the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can     improve the survival of patients with myelodysplastic syndrome   "
114005|NCT01793662|"     Patients with severe atherosclerotic occlusive disease can be operated with an aortobifemoral     bypass(ABFB)through a median laparotomy. Since 1993, the vary operation has also been     performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive     as compared to the open ABFB. The cohort studies published so far have shown that although a     longer operation time with the laparoscopic procedure as compared to the open surgery, the     patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic     complications and earlier reconvalescence.      However, no randomized control trial has yet been published to compare the two procedures.      In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC     type D atherosclerotic lesion shall be randomized to either totally laparoscopic     aortobifemoral bypass operation (LABFB)or an open ABFB operation.   "
127730|NCT01613170|"     The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the     use of Toviaz alone for the treatment of overactive bladder.   "
114007|NCT01793636|"     When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This     is very difficult to treat and almost all patients will die of their disease within 2 years     of the diagnosis.      Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for untreated     patients with metastatic kidney cancer. They target a growth factor known as VEGF which is     important in treating kidney cancer. Although the results with this drug are impressive,     patients develop resistance to the drug and stop therapy. It is currently standard practice     is to give everolimus when resistance to sunitinib occurs; this is associated with clear     clinical benefit.      However the average time to cancer regrowth with everolimus is only 5 months. It is thought     this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2).     Therefore further improvement in treating patients is required. AZD2014 is a promising new     drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in     renal cancer as it theoretically could may have advantages over everolimus. Therefore study     compares AZD2014 to everolimus in the setting where everolimus is used as standard of care.     (e.g. in patients who have failed drug like sunitinib). The study is a randomised trial     allowing us to quantify the benefit and potential for further development of AZD2014. Repeat     Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will     be closely followed up in clinic to ensure safety. A maximum of 122 patients will be     recruited into this multi centre national trial. The primary goal of the study is to     investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to     everolimus.   "
114008|NCT01793623|"     Over the past decade, techniques have been refined which permit an enormous amount of     information relevant to disease mechanisms to be gained from the examination of heart tissue.     The Cardiovascular Institute has extensive experience with these techniques, and has utilized     them to examine other heart disease substrates. In this study, the investigators propose to     obtain heart tissue at the time of cardiac surgery which would otherwise be discarded. Their     plan is to examine this tissue and correlate their findings with clinical data. Their hope is     that the proposed study will provide insight into atrial physiology, including the molecular     mechanisms underlying atrial disease and the potential development of atrial fibrillation     (AF).   "
114009|NCT01793610|"     This small (pilot) study is designed to provide information on whether psychotherapy     combined with the drug MDMA is safe and helpful for people with posttraumatic stress disorder     (PTSD). The researchers plan to use the results of this study to design further studies. This     study will compare two doses of MDMA active dose 1, two doses of MDMA active dose 2, or     comparator-dose MDMA. There will be an initial dose possibly followed one and a half to two     and a half hours later by a second dose half the size of the first dose. The study will     measure symptoms of PTSD, depression, general psychological well-being and sleep after a low     dose versus active doses of MDMA. Subjects experiencing pain or tinnitus (ringing in the     ears) at the start of the study will report on levels of pain or tinnitus during the study.     The study will also examine whether following the standardized treatment is related to     changes in PTSD symptoms. Subjects will be prepared for MDMA-assisted psychotherapy prior to     the first session, and he or she will work with the same pair of therapists after having two     MDMA-assisted psychotherapy sessions, with the second session occurring three to five weeks     after the first session. Symptoms of PTSD, depression, general psychological well-being,     feeling that you or the world are unreal (dissociation), potential positive effects of     traumatic events and sleep quality will be assessed one month after the second MDMA-assisted     session. Cognitive function will be measured one month after the second MDMA-assisted     session. Participants who received comparator-dose MDMA can enroll in Stage 2, wherein they     will have three MDMA-assisted psychotherapy sessions. People who received either active-dose     MDMA will have a third MDMA-assisted session. Cognitive function will be measured again after     two months last Stage 1 or Stage 2 MDMA-assisted session.Subject PTSD symptoms, depression     psychological symptoms, other symptoms and sleep two months after their final MDMA-assisted     session and at least 12 months after they began the study.   "
114010|NCT01793597|"     Patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor.     In a large clinical trial, treatment with ticagrelor before coronary bypass surgery (CABG)     was associated with a lower risk of death than treatment with clopidogrel. The reason for     this difference cannot be explained on the basis of the study. One possible explanation is     that the reversible binding of ticagrelor is advantageous because when new platelets are     released, they are inhibited by the drug. Because clopidogrel binds irreversibly it cannot     redistribute. The investigators will recruit patients who are scheduled for surgery after an     acute coronary syndrome who have been treated with either ticagrelor or clopidogrel. After     the patient provides informed consent, the investigators will review their medical     record,record information and on the day after surgery the investigators will take one sample     of blood. That blood will be analyzed for evidence of platelet activation (platelet     microparticles, and platelet-leukocyte aggregates), the reactivity of young platelets, and     the concentration of inflammatory cytokines. The investigators hypothesize that the evidence     of platelet activation (platelet microparticles and platelet-leukocyte aggregates) and the     reactivity of young platelets will be less in patients who have been treated previously with     ticagrelor.   "
114011|NCT01793584|"     The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety,     and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to     abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through     a randomized surgical trial.   "
114012|NCT01793571|"     An prospective double blinded randomised trial,whether the use of an perioperative echoguided     unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal     repair compared to wound infiltration with a long acting local anesthetic.   "
114013|NCT01793558|"     This study should evaluate whether newborns during cesarean section are endangered to get     hypothermic while bonding on the mothers chest.      Therefore, the investigators want to investigate the effects of active cutaneous warming of     the mothers and babies during intraoperative bonding. The investigators plan to enroll 40     parturients scheduled for elective caesarean section to receive passive insulation or     forced-air skin surface warming. The investigators will measure core temperature of the     newborns and their mothers. The investigators hypothesize that newborns became most often     hypothermic without active warming during the bonding procedure and that active warming will     be able to decrease the number of hypothermic newborns significantly.   "
114019|NCT01793480|"     This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the     clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in     patients with inadequate pain relief or intolerable side effects when treated with level 3     opioid.      Principal objective is to compare the clinical effects (success/failure) of two methods of     methadone titration in patients with cancer-related pain inadequately relieved or with     intolerable side effects after treatment with level 3 opioid.      Secondary objectives are : Overall safety of methadone during the study, to describe the     patients' characteristics, to describe the effects of methadone on pain relief, to describe     the methadone administration, to evaluate patient's quality of life, to evaluate the     prescriber's opinion regarding the handling of methadone initiation.   "
114014|NCT01793545|"     Background:      - Endometrial cancer is one of the most common gynecologic cancers. If it is caught at an     early stage, it can be treated more easily. Women who have this type of cancer often have a     history of irregular menstrual bleeding. They may also have abnormal findings during     gynecologic exams. Pap smears and cervical cell collection may be able to collect cell     samples for cancer testing. However, samples from the vagina or endometrium may produce more     accurate results. Researchers want to collect vaginal and endometrial cell samples to improve     their tests for and understanding of endometrial cancer.      Objectives:      - To collect vaginal and endometrial cell samples to study endometrial cancer.      Eligibility:      - Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal     bleeding, or abnormal ultrasound findings.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have a pelvic exam. Before the exam, they will insert a small tampon          in the vagina. The tampon will stay in place for about 10 to 30 minutes. The tampon will          then be removed and collected for the study.        -  During the pelvic exam, tissue will be collected from the uterine lining with a special          brush. An additional sample (biopsy) will be collected from the lining.        -  A blood sample will also be collected as part of the study.   "
114015|NCT01793532|"     Background:      - Some people with epilepsy have an epileptic focus, a small part of the brain that is the     starting point of the seizure. This focus is like an irritant or an inflammation, and helps     cause the seizure. People with epilepsy that affects the temporal lobe of the brain often     have an epileptic focus. Researchers want to look at the epileptic focus by using a drug that     attaches to a protein associated with inflammation. An imaging study with the drug will show     how much inflammation is in the area of the brain where the seizures start. The drug, called     [11C]DPA-713, will be tested for its effectiveness in people with temporal lobe epilepsy. Its     effects will be compared with imaging studies given to healthy volunteers.      Objectives:      - To see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.      Eligibility:        -  Individuals at least 18 years of age who have temporal lobe epilepsy.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants will have three outpatient visits to the National Institutes of Health          Clinical Center. The visits will last from 2 to 5 hours.        -  Participants will be screened with a physical exam, neurological exam, and medical          history. Blood samples will be collected before the start of the study.        -  Participants will have a positron emission tomography (PET) scan. This scan will be used          to look at brain chemistry and function. The study drug will be given during the scan to          see how well it shows points of inflammation in the brain. Some participants will          provide additional blood samples during the PET scan.        -  Participants will also have a magnetic resonance imaging (MRI) scan. This scan will look          at the structure of the brain.   "
114016|NCT01793519|"     Background:        -  Rheumatoid arthritis (RA) is often treated with drugs known as tumor necrosis factor          (TNF) inhibitors, that can help decrease joint pain and swelling and can even result in          RA remission. However, TNF inhibitors may increase risk of serious infections or some          types of cancer.        -  It is not clear if people whose RA has been in remission for a long time need to stay on          the TNF inhibitor to remain in remission. If they can stop taking the TNF inhibitor          without having their symptoms come back, they will be spared the side effects of these          medicines. Some studies have shown that people can stay in remission after stopping a          TNF inhibitor, but other studies have not confirmed it. Researchers want to see if          people with RA in remission on a TNF inhibitor can stay in remission without this          medicine. Also there may be a clinical, imaging (MRI, ultrasound), laboratory profile          that will help to determine which patients remain in remission after stopping these          drugs.      Objectives:        -  To see whether RA remission can continue after discontinuing use of a TNF inhibitor.        -  To determine if clinical, imaging and immunological measurements can predict which          participants will flare and which will remain in remission after discontinuing TNF          inhibitor.      Eligibility:      -Individuals at least 18 years of age who have RA that is being controlled with TNF     inhibitors. We plan to randomize 291 patients.      Design:        -  The study has seven visits over about 2 years. Six visits occur in the first year of the          study, about 12 weeks apart. The final study visit is 1 year after the end of the          treatment phase.        -  At the first visit, participants will be screened with a physical exam and medical          history. They will complete a questionnaire about their RA symptoms. A blood sample will          be collected. They will continue to take their RA medicines during this time.        -  The second visit will repeat tests from the first visit. These tests will confirm that          the RA is in remission. Imaging studies will be performed on the hands, wrists, feet,          and their connected joints. After this visit, participants will stop taking their TNF          inhibitors and will start to have injections of a study drug. This drug will be either          the participant's original TNF inhibitor or a placebo.        -  There will be follow-up visits at weeks 12, 24, and 36. Participants will have a medical          history and joint exam. They will also provide blood samples and answer questions about          their RA symptoms.        -  At the sixth visit (week 48), participants will repeat the tests and imaging studies          from the second visit. They will stop taking the study injections.        -  Continued RA treatment after this visit will be decided by the participant and his or          her rheumatologist. Participants may take any recommended medicine, including the TNF          inhibitor they had been taking before the study. They will also receive a questionnaire          to complete at home and mail back before the final study visit.        -  At the final visit (week 100), participants will repeat the tests and imaging studies          from the second and sixth visits.   "
114017|NCT01793506|"     The purpose of this study is to evaluate a novel screening test to detect patients with     primary immunodeficiencies(PIDs). The investigators plan to use information gained from this     study in order to advance the field of clinical immunology, thus improving the diagnosis,     treatment, and well-being of future patients. The purpose of this study is to determine if     this screening test is able to detect patients with immune problems, and the investigators     will test patients with known PIDs to determine if the test is accurate      The investigators hypothesize that detecting serum immunoglobulins from dried blood spots     will be effective in detecting patients with known primary immunodeficiencies. If our     hypothesis is confirmed, it opens the possibility of using point of care testing to screen     for primary immune deficiencies.      Age of study subjects will range from 1 year to 80 years of age, and will be recruited form     the Immunodeficiency clinic at the Medical College of Wisconsin/Children's Hospital of     Wisconsin (MCW/CHW). Any subject having testing done to evaluate the immune system is     eligible for this study. This will include patients with known PIDs as well as patients     evaluated for a suspected immunodeficiency. It is anticipated that 150 subjects will be     analyzed over a two year period.   "
114018|NCT01793493|"     The Allena-Mente study is a randomized, controlled, single-blind trial assessing the efficacy     of cognitive stimulation (CS) compared to an active control group, participating to sanitary     education lessons (AC). This non-pharmacological intervention is delivered to Mild Cognitive     Impairment (MCI) and cognitively healthy individuals with first-degree relative with dementia     (NDFAM).   "
114046|NCT01793129|"     This study is a randomized, controlled trial to assess safety and effectiveness of whole body     hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at     <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will     enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly     assign them to either receive hypothermia or participate in a non-cooled control group.   "
130160|NCT01581333|"     Clinical trial intended to reduce the antibiotic therapy duration in in-hospital patients     with haematological diseases who develop fever and low white blood cell count (neutropenia).   "
114020|NCT01793467|"     Raltegravir (RAL) is a preferred option for initial antiretroviral therapy in the most recent     HIV Treatment Guidelines and is emerging as a popular choice for use in the specialized     population of HIV-infected patients being considered for solid organ transplantation. Data     from HIV-infected persons with normal organ function have revealed few raltegravir-associated     metabolic complications compared to older antiretrovirals, and in general, drug-drug     interactions with raltegravir are infrequent. The absence of such concerns appears to make     raltegravir a potentially appealing option for antiretroviral therapy in HIV-infected     patients being considered for solid organ transplantation.      At present, however, little is known of the safety and long term tolerability of     RAL-containing regimens in persons undergoing solid organ transplantation. As more     HIV-infected patients undergo organ transplantation, there is a growing need for good data on     such things as the effect of dialysis on RAL concentrations, the potential interactions with     commonly used immunosuppressive drugs, and the pharmacokinetic (PK) /pharmacodynamic (PD)     characteristics in those with end stage organ failure, as well as those with functioning     grafts.      The proposed study will also examine transplant function and survival in HIV-infected     patients receiving RAL-containing ART and will compare it to HIV negative historic controls.   "
114021|NCT01793454|"     Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative     stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality,     preanesthetic and postanesthetic expiration tidal volumes.   "
114022|NCT01793441|"     This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of     concept study will investigate the efficacy and safety of RG7314 in adult participants with     ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral     doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety     review, the study may proceed to Stage II. In Stage II of the study, additional participants     will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks.     After an independent safety review, Stage III will be started wherein additional participants     will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12     weeks. During Stage III, safety will be reviewed by independent safety review twice and if no     safety signal is observed, then additional participants will be randomized in 1:1:1 either to     receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in     Stage IV.   "
114023|NCT01793428|"     13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion     of six or more units of packed Red Blood Cells. It is currently difficult to predict the need     for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and     blood pressure can be normal during the first hours despite intensive bleeding.      It's well known that blood or arterial lactate measures correlate with trauma severity but     these measures are not available in a pre-hospital setting. The investigators want to test     whether capillary lactate measures also correlate with trauma severity and can therefore     predicts earlier transfusion needs.   "
114024|NCT01793415|"     Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS     experience overwhelming fatigue and a host of other symptoms that are not improved by bed     rest. Interestingly, many of the symptoms experienced by people with CFS are identical to     symptoms caused by long-term low-level exposure to mercury, which is called     micromercurialism.      This study will examine if the mercury binding substance IodoCarb(r) can improve the health     of patients with CFS.   "
114025|NCT01793402|"     Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of     vitamin D deficiency in early preterm infants is unknown. The American Academy of Pediatrics     recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of     vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D.     This study assesses vitamin D status at birth and during hospital stay in infants delivered     delivered at earlier than or at 32 weeks gestation. We also assess the adequacy of intake     relative to the target set by the American Academy of Pediatrics for children.   "
114026|NCT01793389|"     The present study deals with treatment of localized gingival recessions. The hypothesis of     this study is that platelet rich fibrin can be used an alternative to subepithelial     connective tissue graft in the coverage of denuded roots. If the platelet rich fibrin will     prove to be similarly effective as subepithelial connective tissue graft, it will be possible     to avoid a donor site and to decrease patient discomfort after operation.   "
114027|NCT01793376|"     Hypothesis This study is designed as an integral part of the development of a new CE score     for Crohn's disease.      The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated     CD score for SB involvement. In order to expand this score to the colon, this study will aim     to develop the colonic score and later on will be combined with the already established SB     score in order to achieve a full CE gut score for Crohn's disease Proposed Design This is a     retrospective study in which up to 30 videos of colon Crohn's disease subjects who have     undergone the Colon 2 CE procedure will be evaluated.      These cases will have evidence of large and / or small bowel Crohn's disease The chosen     videos will be marked for CD lesions by the site The de-identified marked videos will be     scored by 4 independent experienced endoscopists, blinded to the results of the standard     workup procedures, according to the colonic and CECDAIic new scores   "
114028|NCT01793363|"     Prospective, interventional multicentric study in ICU during weaning from mechanical     ventilation in tracheotomized patients   "
114047|NCT01793116|"     This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in     NICHD Neonatal Research Network (NRN) centers. The registry collects observational baseline     data on both mothers and infants, and the therapies used and outcomes of the infants. The     information collected is not specific to a disease or treatment (i.e., it is generic). Data     are analyzed to find associations and trends between baseline information, treatments, and     infant outcome, and to develop future NRN trials.   "
114048|NCT01793103|"     The goal of the present study is to establish a prospective observational cohort of     Rheumatoid Arthritis patients in order to        1. Determine and validate biomarkers that predict drug response and toxicity in RA.        2. Determine and validate biomarkers that predict disease activity and prognosis in RA.        3. Evaluate the natural history of treated RA in terms of its clinical, functional and          economic outcomes.   "
114029|NCT01793350|"     A combined Phase 1 & 2 study to evaluate the safety and effectiveness of a new diabetic     neuropathy topical cream, containing benfotiamine, will be performed at 5 clinical sites and     plans for BC-DN-01 administration in up to 135 volunteer patients using a standard Phase 1 +     2 design. Up to 15 subjects will receive BC-DN-01 in Study Phase 1 and up to 120 subjects     will receive BC-DN-01 or placebo in Study Phase 2.      In Phase 1, a BC-DN-01 dose delivering 160mg benfotiamine/day (80mg twice daily) will be     administered for the first 7 days. On visit day 0, patients will commence study treatment.     Patients will be interviewed by phone on day 3 and return to clinic on day 7 for safety     assessments. If the drug is well-tolerated and no significant adverse events experienced, the     total daily BC-DN-01 dose will be increased on days 7-14 to 320mg benfotiamine/day (160mg     b.i.d.). Patients will be interviewed by telephone on day 10 and return to clinic on day 14     for safety assessments.      Once the safety profile has been determined in Phase 1 as acceptable, the Phase 2 study will     be initiated to evaluate clinical efficacy of BC-DN-01. Phase 2 is a randomized,     placebo-controlled, double-blind, parallel study. Participants receive placebo or BC-DN-01     based on 1:1 randomization. Each patient will apply 4g of the study medication to each leg     twice-a-day administering 320mg benfotiamine dose/day for 12 weeks.      Participants will be evaluated in the clinic at baseline and at 4, 8, and 12-week time     points; study staff will interview the patients by telephone on weeks 2, 6, and 10.      The primary endpoint of the phase 2 trial is reduction in DPN pain measured by the Brief Pain     Inventory. Phase 2 patients will be invited to give written consent to take part in biopsy     sampling and additional gene expression analysis.   "
114030|NCT01793337|"     Accurate measurement of core body temperature at the scene of an accident is critical for     both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the     lower third of the oesophagus is considered the gold standard of CT reading, but invasive and     hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have     been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the     Double Sensor device is a non-invasive device and is promising for prehospital use but has     not been sufficiently verified under very cold and hot environmental conditions. Furthermore,     comparisons of different non-invasive methods with oesophageal measurement in extreme     conditions are lacking. The objective of these studies is to compare different techniques of     core body temperature measurement with exposure to cold and hot environments.   "
114031|NCT01793324|"     A study to evaluate the effectiveness of an update of educational materials with respect to     evaluation of monitoring of metabolic parameters   "
114032|NCT01793311|"     The goal of the study is to determine the effect of different doses of caffeine on     intraocular pressure. We hypothesized that higher dosage of caffeine would increase     intraocular pressure more than lower doses.      Eligible subjects will be randomized into three groups:        1. group 1: intake of decaffeinated coffee        2. group 2: intake of coffee with lower caffeine dose        3. group 3: intake of coffee with higher caffeine dose      Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.   "
114033|NCT01793298|"     The purpose of this study is to evaluate the safety and tolerability of the dry powder     formulation of ASM-024 following single and multiple administration by inhalation of     ascending doses in healthy subjects and subjects with stable moderate asthma.   "
114034|NCT01793285|"     Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg     improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid     arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period,     we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing the     efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in     subjects with AS refractory to conventional therapy. The interim results of said study do not     appear to support the value of doubling the dose of etanercept in the treatment of subjects     with AS. Once this study was finalised, the subjects continued to be monitored by their     regular physician, who decided on the dose and treatment to follow according to the     conditions of standard clinical practice.      The objective of this observational study is to evaluate the course of the disease in the     long-term (three years) under the conditions of standard clinical practice, in subjects who     had participated in the LoadET study. Therefore, we would like to follow-up on those patients     by reviewing their clinical histories for the three-year period between the finalisation of     their participation in the LoadET Study (0881A3-102090) and now. This will allow us to assess     the efficacy and survival of the drug, as well as the possible appearance of side effects in     the three years following the finalisation of the study by comparing the results according to     if the subjects had received 50 mg/week or 100 mg/week during the LoadET study (0881A3     102090).   "
114035|NCT01793272|"     To evaluate the effect of pentoxifylline used in preparation of semen samples that will be     used for ICSI in infertile men complaining of mild and moderate asthenozoospermia (i.e. cases     which does not need motility enhancement prior to ICSI) in comparison to semen samples     without pentoxifylline preparation on the outcome of ICSI.   "
114036|NCT01793259|"     The primary objective of this study is to assess the number of patients preferring the     methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment     based on a questionnaire   "
114037|NCT01793246|"     Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung     lesions or for detection of acute rejection following lung transplants. The hypothesis is     that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or     incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.   "
114038|NCT01793233|"     This clinical trial studies blood sample markers of reproductive hormones in assessing     ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood     from patients with cancer in the laboratory may help measure the effect of curative therapy     for lymphoma on ovarian failure.   "
114059|NCT01792947|"     Based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve     terminals located in dermatome T6 may cause a reflex, whose efferent pathways end in vagal     nerve branches stimulating the gastric wall, similarly to the gastric pacemaker.      The aim of this study was to evaluate the effect of percutaneous electroneurostimulation     (PENS) of T6 dermatome on appetite, weight loss and dietary compliance.   "
114039|NCT01793220|"     The aim of this research is to find out if mobile phone text message reminders of     appointments can help to address missed appointments in Psychosis Community Services. Another     aim is to examine if fewer missed appointments result in clinical benefits for service users     and in lower costs for Psychosis Community Services over a period of 6 months. 600 users from     2 London Psychosis Community Services will take part in this research. Each participant will     be put into one of two groups, as s/he joins the study: In the first (experimental) group,     each participant will receive appointment reminders for 6 months (7 and 1 day/s before each     appointment), starting with the first available opportunity upon joining the study. In the     second (control) group, each participant will not receive appointment reminders for 6 months.     The choice of group for each individual will be made at random by a computer. Clinical     information will be collected for 6 months from the time each participant joins the study,     using, with his or her consent, their anonymised electronic medical records. The following     clinical information will be compared between the experimental and control groups: Attendance     of appointments, number of inpatient admissions, number of days in inpatient care, number of     inpatient admissions under the mental health treatment act, number of referrals to a home     treatment team, number of times patient has changed medication, health and social     functioning. Service use, service costs and the cost-effectiveness of the reminder system     will also be examined. Towards the end of their participation, service users, as well as     mental health professionals, will be invited to express their views, concerns and suggestions     in relation to the reminder service by completing a brief anonymised (service users) or     anonymous (staff) questionnaire   "
114040|NCT01793207|"     The incidence of colorectal cancer (CRC) is on the rise on a global scale. The number of     cancer-related deaths related to CRC is also rising to an alarming level. This picture is     similarly seen in Egypt where the incidence of colorectal carcinoma is increasing annually,     moreover, CRC in Egypt exhibits an alarming characteristic which is the affection of much     younger patients than their counterparts worldwide. Fortunately, the early detection of CRC     and its precursor (adenoma) has been shown to markedly decrease morbidity and mortality     related to this tumor, this has prompted the development of robust screening programs for CRC     in several western countries. The implementation of a CRC screening program in Egypt has been     hampered by the low compliance of the patients and the relatively high cost of colonoscopy.     There is a need for an affordable, non-invasive, simple, accurate and socially accepted     screening test to allow such a program to succeed in Egypt. Recent studies have shown that     DNA is the future target of screening tests for several malignancies. Particularly for CRC a     few preliminary studies have shown encouraging results with separate DNA methylation markers     both in blood and stool. In our efforts to develop a screening test with the criteria stated     above, the investigators have decided to join the forces of 2 of the largest medical centers     in Egypt and the middle-east: Kasr-Alaini hospital and the National cancer institute (NCI).     The investigators plan to test a panel of 7 DNA methylation markers in peripheral blood for     their performance as an early marker for CRC and colorectal adenomas. Data from this study     will pave the way for the development of a screening test for CRC tailored to the Egyptian     population, moreover, it will supply essential data about the genetic alterations occurring     in CRC in Egyptian patients.   "
114041|NCT01793194|"     Problem: Approximately 4 million live births occur in the United States each year. Pregnancy     causes many physical changes in the mother, including venous distension, increased ability to     form blood clots, and hormonal changes. Data suggest that these factors help cause venous     insufficiency (when the veins do not adequately return blood from the extremities to the     torso). As venous insufficiency progresses, complications follow, the most severe of which     include superficial thrombophlebitis and deep venous thrombosis (DVT, or blood clots).     Although the fear of DVT has been well publicized, its prevention and prevalence in pregnant     women has not been well-studied.      The exact cause of venous insufficiency is not known. However, known risk factors include     being female and hormonal changes associated with oral contraceptive use, certain hormone     replacement medications, and pregnancy. Being pregnant places the mother at additional risk     for developing venous insufficiency.      Compression stockings are used to manage the condition, but this is by no means standard of     care despite their easy use and safety. The medical community's understanding of how     compression stockings work is largely theoretical; however, it is believed that the     compression works by preventing venous hypertension in the lower legs, thereby preventing     venous insufficiency and its associated complications.      Research hypothesis: The investigators hypothesize that compression stocking use will be     associated with lower incidence of varicose veins and, in those patients who already have     varicose veins, lower incidence of complications associated with venous insufficiency.     Further, the investigators believe that compression stocking use will be associated with a     lower incidence or lessening of symptoms associated with venous insufficiency.      Importance: An undetected DVT can be fatal. Even if detected promptly, DVT is associated with     long term health problems. Treatment of a DVT requires anticoagulation which can be risky to     both mother and fetus. The prevention or reduction of DVT in pregnant women through use of     compression stockings would revolutionize their care. Further, this intervention is safe and     noninvasive.      The investigators propose to conduct a randomized, pilot study comparing pregnant women     without and with varicose veins randomized to wear compression stockings to a similar group     of participants randomized to no compression stocking use.   "
114042|NCT01793181|"     Retinal vein occlusion (RVO) is a common vascular disease of the eye. Studies have shown that     the risk of venous thrombosis is higher in winter so even concerning RVO. Studies have shown     a possible link between sun exposure and venous thrombosis. Vitamin D levels have been shown     to have a similar seasonal variation, with a peak occurring in the summer. The primary source     of vitamin D is from sunlight when ultraviolet B (UVB) radiation penetrates the skin and     converts 7-dehydrocholesterol to 25-hydroxycholecalciferol vitamin D3 (25-OHVitD) via     previtamin D. In Stockholm situated at latitude 59˚ 20΄ North, it is not possible to     synthesize vitamin D at sufficient levels in winter and the exposure time required to reach a     standard dose is impractical from at least October through March.      The aim of the study is to evaluate vitamin D levels in central retinal vein occlusion (CRVO)     patients and compare them with the vitamin D levels in randomly selected control patients     matched for age and month of disease onset. This is to evaluate whether vitamin D deficiency     may be a risk factor in the onset of CRVO.      The hypothesis of the study is that patients with CRVO have lower levels of vitamin d than     matched controls.   "
114043|NCT01793168|"     CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux     Falls, South Dakota. It provides researchers with a centralized, international patient     registry for all rare diseases. This program allows patients and researchers to connect as     easily as possible to help advance treatments and cures for rare diseases. The CoRDS team     works with patient advocacy groups, individuals and researchers to help in the advancement of     research in over 7,000 rare diseases. The registry is free for patients to enroll and     researchers to access. Visit sanfordresearch.org/CoRDS to enroll.   "
114044|NCT01793155|"     The purpose of this study is to evaluate the effects of postoperative inspiratory muscle     training on the recovery of respiratory muscle strength in high risk patients referred for     lung cancer surgery. Furthermore, to assess longitudinal changes in respiratory muscle     strength, physical capacity and health-related quality of life after lung cancer surgery   "
114045|NCT01793142|"     This survey is conducted for preparing application material for re examination under the     Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and     efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for     New Drugs   "
114049|NCT01793090|"     The aim of the research is to investigate the safety and efficacy of EPI-743 treatment in     patients with Cbl-C defect and related visual and neurological impairment. Primary Endpoints     will be the improvement in visual function as assessed by visual acuity and eye-hand     coordination and manual dexterity. Secondary Endpoints will be the improvement in neurologic     function, evaluated by a battery of age-appropriated psychophysical tests, and/or in     objective electrophysiological tests such as Visual Evoked potentials (VEP) and     Electroretinogram (ERG) and/or the change in serum markers of redox state.   "
114050|NCT01793077|"     Tremodi is an observational, non-interventional, prospective, open-label, non-comparative     study that will collect real life data of a treatment with Depo-Eligard® in 3 different     administrations in male prostate cancer patients.      Once the examining physician has decided on the therapeutic approach and if the selection     criteria are fulfilled, he will propose the patient to participate in the study. An informed     consent form will be collected for all participants in the study.      There are 2 possible study visits that coincide with a routine consultation, namely visit 1     (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions     (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to     complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician     will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment     benefit of the patient.      Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both     visits, if available.   "
114051|NCT01793064|"     The purpose of this study is to develop and evaluate an adaptive shaping intervention based     on Behavioral Economics and Operant principles to promote physical activity behaviors     (adaptive group) and compare to a static physical activity intervention (static group) using     a two-group randomized controlled trial design. Participants will include 20 overweight men     and women (BMI 25-35 kg/m2) between 18 to 55 years. Both groups will receive the following     components: 1) a pedometer, 2) self-monitoring of physical activity, 3) brief educational     materials, 4) motivational prompts, 5) physical activity goals, and 6) small financial     incentives. The Adaptive Intervention (AI) group will receive adaptive goals and feedback     based on percentiles and a moving window of their recent physical activity, with incentives     linked to goal attainment. Comparison intervention participants will receive the static     10,000 steps per day goal, with matching incentive amounts but without incentives linked to     goal attainment. The study will compare differences in goal setting and shaping procedures     that aim to increase physical activity behavior.      Primary aims include:        1. To determine whether physical activity (pedometer-measured steps/day) in both the          Adaptive and Static interventions increased compared to their respective baselines.          Hypothesis: Both the adaptive and static interventions will result in increased physical          activity over 6 months.        2. To evaluate whether the Adaptive Intervention results in greater change in physical          activity (pedometer-measured steps/day) compared to the Static Intervention. Hypothesis:          The adaptive intervention will result in significantly greater physical activity,          measured by pedometer, compared to the static intervention over 6 months.        3. To assess participants' satisfaction with the overall program. Hypothesis: Adaptive          Intervention participants will report greater overall satisfaction with the intervention          than the Static Intervention participants.   "
114052|NCT01793051|"     The goal of this clinical research study is to learn if minocycline can help reduce the     symptoms reported by patients with MM who receive therapy with lenalidomide.      Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine     production, which may help to reduce multiple symptoms.   "
114053|NCT01793038|"     Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent     periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the     standard first drug of treatment for ovulation induction. Ovulation and conception will occur     in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to     doses of clomid up to 150 mg/day are known as clomid resistant PCOS.   "
114054|NCT01793025|"     The purpose of this study is to assess the safety and efficacy of infusing immune cells from     a donor as treatment for patients with acute myeloid leukemia that is resistant to     chemotherapy or who have experienced relapse. Unlike standard bone marrow or stem cell     transplantation which uses donors who are well 'matched' to the patient, this study uses     donors whose immune cells are not compatible with the patient. With standard stem cell or     bone marrow transplantation, the well-matched immune cells will attack the leukemia but they     also attack the patient's organs (a situation called graft-versus-host disease, which can     persist in the long term). Our hypothesis is that the mismatched donor cells will fight the     leukemia but will then be eliminated from the patient's body, so long-term side effects like     graft-versus-host disease should not occur.   "
114055|NCT01793012|"     Infections are critical factors for the survival of critically ill patients. A broad,     high-dose and early initial therapy of antibiotics is of particular relevance.      A serious problem is the high variability of antibiotic serum concentrations after     administration of antibiotics in patients of the critical care units. This may result in the     risk of underdosage with possible ineffective therapeutic levels as well as in the risk of     overdosage with possible adverse and toxic effects. The goal of this study is to determine     antibiotic concentrations in blood and to evaluate concentrations with the course of the     therapy. The measurement of antibiotic concentrations in blood may allow an individual     adaption of the dose in future.      100 - 200 patients will be included in this study. Only critically ill patients of the ICU of     the Department of Anaesthesiology will be included that receive one or more of the following     antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and     colistin.   "
114056|NCT01792986|"     This study will determine whether an intensive fasting protocol alters hemoglobin A1c     measurements or other markers of metabolic and cardiovascular risk by performing a 5-week     clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is     controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour     water-only fasting, including at baseline and at the end of the week for each week of the     study (a total of 6 24-hour fasts).   "
114057|NCT01792973|"     HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort     study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort     of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the     prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical     lesion. The study will also provide the distribution of the HPV genotypes involved as well as     other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals, older     than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed to     participate. An annual gynecological examination with a Pap-smear and a sampling for HPV     testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection     receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is     provided according to the National Guidelines.   "
114058|NCT01792960|"     Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence     of gene mutations in Korean patients with familial hypertrophic cardiomyopathy   "
114060|NCT01792934|"     The purpose of this study is to compare overall survival rates of colorectal cancer patients     with multi-organ metastases with an indication for first line systemic treatment randomized     for treatment with combination chemotherapy or treatment with combination chemotherapy and     additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE and     SBRT, depending on best clinical judgement according to a standardized treatment algorithm.     Our hypothesis is that maximal tumor debulking in addition to systemic treatment with     chemotherapy and biologicals will provide an improvement in progression free and overall     survival in this patient group.   "
114061|NCT01792921|"     Scientific Rationale: Many children with ADHD have serious difficulties in participation in     daily occupations in their ecological settings. These difficulties have a pervasive negative     impact on their everyday functioning and quality of life (QoL). Although pharmacological     treatment has been proven effective in treating ADHD symptoms in many children, as have     psychosocial interventions such as parent training, there is little evidence for integrative     approaches that address the cognitive, volitional and social-environmental barriers to     participation with this population. Although preliminary positive effects of a     cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been     demonstrated, additional evidence is needed to confirm these initial findings. Methods:     Initial results of our pilot study (N=17 children with ADHD) demonstrated significant     moderate to large effects of Cog-Fun treatment, which targeted participation and executive     functions in daily life. Significant effects were also found for a measure of self-efficacy     and neuropsychological measures of attention, planning and organization. Parent ratings     showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current     study is to replicate the pilot study findings in a randomized controlled trial. The study     will be a randomized controlled trial with a crossover design, including 2 groups of children     with ADHD attending elementary school and their parents. The research group (Group A, n=50)     will receive three months of the Cog-Fun treatment, designed for a parent/child dyad and the     control group (Group B, n=50) will be wait-listed and receive treatment after three months.     Outcomes will include measures of participation, executive functions in daily life, child and     parental self-efficacy, ADHD symptoms and QoL. The investigators expect to find a significant     main effect of time (pre-post intervention), group (research vs. control) and a significant     interaction effect (group x time) on executive and occupational outcome measures.   "
114062|NCT01792908|"     The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase     protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy     volunteers immediately after its application and 48 hours later.   "
114063|NCT01792895|"     The purpose of this study was to investigate the comparative effectiveness of high velocity     and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT)     in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate     effects in range of motion and pain thresholds, and the interaction between psychological     factors and the outcomes of these three types of manual therapy.      The hypothesis is that all manual therapies techniques will produce similar effects.   "
114064|NCT01792882|"     The study is intended to collect specimens to support the application of genome analysis     technologies, including large-scale genome sequencing. This study will ultimately provide     cancer researchers with specimens that they can use to develop comprehensive catalogs of     genomic information on at least 50 types of human cancer. The study will create a resource     available to the worldwide research community that could be used to identify and accelerate     the development of new diagnostic and prognostic markers, new targets for pharmaceutical     interventions, and new cancer prevention and treatment strategies. This study will be a     competitive enrollment study conducted at multiple institutions.   "
114065|NCT01792856|"     Jockey Club Early Psychosis (JCEP) project is a territory-wide specialized EI service that is     launched in August 2009 and provides 3-year phase-specific intervention for adult patients     presenting with first-episode psychosis (FEP) to psychiatric units of Hospital Authority     (HA). To promote early functional recovery, JCEP project develops recovery-oriented     intervention based on life coaching approach (recovery-oriented coaching) in addition to case     management. This is a structured group-based coaching program incorporating     cognitive-behavioural and solution-focused therapeutic components. The program facilitates     patients to undergo active change process via identification of achievable goals, formulation     of action plans, provision of feedback and progress monitoring for goal attainment. Subjects     will be randomized (block size: 2) to receive either recovery-oriented coaching program     (intervention group) or supportive therapy (control group).      Intervention group Subjects are scheduled to receive a 6-month group-based recovery-oriented     coaching program. This is a structured, manualised treatment program based on life coaching     principles with cognitive-behavioural and solution-focused elements incorporated. It guides     subjects to undergo an active, yet stepwise change process by stimulating motivation, setting     achievable goals, generation of action plans via collaborative exploration, fostering     self-regulatory capacity, and provision of autonomy-supportive treatment environment and peer     support. Subjects' perceived competence, sense of control, self-management skills and hence     functioning will be improved via successful experiences and positive feelings generated after     attainment of self-initiated goals. Cognitive-behavioural techniques such as self-monitoring,     activity scheduling and behavioural modification will be employed.      Control group Subjects will receive group-based supportive therapy provided by case managers     of JCEP project. The therapy provides patients with psychoeducation about psychosis, stress     management, emotional and social support. Coaching and cognitive-behavioural techniques will     not be incorporated. Therapy sessions and duration will be comparable to that of     recovery-oriented coaching program.      Assessments Each subject will be assessed at three time points, i.e., baseline before     randomization (T1), 12 weeks (T2, post-phase I intervention) and 24 weeks (T3, post-phase II     intervention). Assessments on symptomatology, functioning and subjective wellbeing will be     administered at all time points. Cognitive and reinforcement learning assessments will be     conducted at T1 and T3. functional magnetic resonance imaging (fMRI) will be performed at T1     and T3 for the first 20 subjects recruited in each treatment group. A group of healthy     volunteers matched in sex, age and educational level will be recruited from the community     with fMRI, cognitive and reinforcement learning evaluations done at T1 and T3. To maintain     blinding to treatment assignment, assessments will be conducted by research assistants who     are independent of treatment delivery and randomization. Subjects will be trained to not     reveal their treatment allocation before each follow-up assessment.   "
114066|NCT01792843|"     -  a data driven approach has identified different cognitive phenotypes in Parkinson's          disease (PD)        -  this heterogeneity possibly reflects the diversity of the neuronal damage caused by the          disease        -  we hypothesize that the different clinical presentations are associated to specific          anatomical and functional correlates   "
114067|NCT01792830|"     Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while they     are in the hospital. No studies have shown what the best insulin regimen is for CABG patients     with type 2 diabetes is after going home from the hospital. Patients with high blood sugar     and diabetes after cardiac bypass surgery will be followed for 3 months to look at how well     their treatment(s) for diabetes work after discharge. Patients with diabetes will be     discharged on oral antidiabetic drugs or with insulin glargine injections based on their     sugar control. Patients with admission HbA1c < 7% (a laboratory value that shows the average     blood sugar level in the body over 3 months) will be discharged on the same diabetes     medications that they used before coming to the hospital. Those with an HbA1c between 7% and     9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and     oral antidiabetic drugs. Those with an HbA1c > 9% will be discharged on glargine at 80-100%     of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin     glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12     weeks after discharge.   "
114068|NCT01792817|"     Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of     non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of     cluster headache. The study compares the safety and effectiveness of an active treatment     (GammaCore) against a sham treatment.   "
114069|NCT01792804|"     Increasing resistance to antibiotic agents has been recognized as a major health problem     worldwide that will even aggravate due to the lack of new antimicrobial agents within the     next decade [1]. This threat underscores the need to maximize clinical utility of existing     antibiotics, through more rational prescription, e.g. optimizing duration of treatment.      Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000     cases occurring annually in Europe [2]. A course of at least 14 days of intravenous     antimicrobials is considered standard therapy [3-5] in uncomplicated SAB. This relatively     long course serves to prevent SAB-related complications (such as endocarditis and vertebral     osteomyelitis) that may result from hematogenous dissemination to distant sites. However,     there is insufficient evidence that a full course of intravenous antibiotic therapy is always     required in patients with a low risk of SAB-related complications.      In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early     switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional     14-days course of intravenous therapy regarding efficacy and safety. An early switch from     intravenous to oral therapy would provide several benefits such as earlier discharge, fewer     adverse reactions associated with intravenous therapy, increased quality of life, and cost     savings.   "
114070|NCT01792791|"     Arthritis is the nation's most common cause of disability. An estimated 50 million U.S.     adults (about 1 in 5) report doctor-diagnosed arthritis. Twenty three million U.S. adults of     working age (18-64 years) have arthritis; and in this age group arthritis-attributable work     limitations affect about 1 in 3 people. An estimated 12% of all patients seeking intervention     for symptomatic arthritis have an etiology of previous trauma to the involved joint.      The purpose of this study is to examine these inflammatory compounds in the joint fluid     (synovial fluid), the joint lining (synovium), and in blood among subjects with isolated     intra-articular fractures.      The hypothesis is that early levels of intra-articular inflammation and markers of joint     tissue degeneration following articular fracture in the human knee are predictive of the     development of PTA (Post Traumatic Arthritis). Early levels of intra-articular inflammation     and markers of joint tissue degeneration identified from human knee joints following     articular injury are predictive of the development of PTA in the mouse knee.      Samples of blood, urine and synovial fluid will be taken at the spanning frame surgery and     only synovial fluid at the ORIF (Open Reduction Internal Fixation)surgery. Two MRIs (Magnetic     Resonance Imaging) will be part of this study at 4 weeks and 18 months.Participants will     complete a set of questionnaires(KOOS: Knee Injury and Osteoarthritis Outcome Score) at 4     weeks and 18 months.   "
114071|NCT01792778|"     The purpose of this pilot study is to collect the necessary information for determining the     appropriate sample size of a statistically powered trial comparing the performance of two     different blood control peripheral intravenous catheters.   "
114072|NCT01792765|"     Kidney stones are very common, and can inflict a significant degree of pain and renal damage.     Some stones become obstructed in the ureter, the tube that drains the kidney. In order to     remove these stones, an Urologist and their team use fluoroscopic guidance to do so, this     involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to the     patient, as well as the health care team, which has been shown to have serious health     consequences. Previous studies have shown that in certain populations, like pregnant women,     stones can be managed using ultrasound guidance. The investigators propose that mid and     distal ureteral stones could be managed using ultrasound guidance in conjunction with     conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent     placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and     patients.      The investigators hypothesize that distal ureteral stones can be identified and efficiently     fragmented and removed under ultrasound guidance in a safe and effective manner without the     use of radiation.   "
114073|NCT01792752|"     The overall goal of this project is to implement and evaluate a community-level, structured     approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico.     The Enhanced HIV Care Access and Retention Intervention will: 1) identify drug users living     with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2)     provide direct HIV care services through a mobile health van; and 3) support identified     HIV-infected drug users with patient navigators to enhance their ability to engage in HIV     care and substance abuse treatment, to initiate antiretroviral therapy, and maintain     adherence to their treatment regimens. The structural enhanced care approach will be     evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The     community-level success of the intervention will be assessed by evaluating virologic     suppression (primary biological outcome), increased attendance to HIV care visits, uptake of     antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as     secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn     from each of the neighborhoods included in the intervention. We will also evaluate the     implementation process and cost of the enhanced care approach including implications for     cost-effectiveness, feasibility of expansion, and sustainability.   "
114074|NCT01792739|"     The purpose of this trial is to clarify the impact of lactobacillus preparation on the     incidence of diarrhea in ICU-admitted patients.      Almost all patients in ICU are treated with antibiotics for the effective control of various     infections. However, antibiotics-associated diarrhea is another matter of concern. Many     previous studies were proved that the use of probiotic lactobacillus preparation can reduce     antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to     perform a similar study in severely ill patients in ICU.   "
114084|NCT01792609|"     Objectives Primary objective: Determine if there is a clinically significant difference in     percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective     randomized controlled trial.      Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety     of low vs. high implant density instrumentation for spine deformity surgery in AIS patients     with Lenke IA curve patterns.      Interventions and Duration Intervention: low-implant density group or high-implant density     group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old     with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is 174     subjects with 87 in each group.   "
114085|NCT01792596|"     The combination of fiber and protein added to pasta will enhance satiety.   "
114075|NCT01792726|"     TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis     that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy     (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost     (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial     in which each participating centre can use the local predefined inclusion/exclusion criteria     for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are     eligible to enter patients into the trial.      Eligible patients are those with a higher risk of local recurrence after breast conserving     surgery.      After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All     patients will receive whole breast EBRT. They may receive any other adjuvant treatments as     deemed necessary. The protocol recommends that patients be followed at six monthly intervals     for three years and then annually.      The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are     relapse-free survival, site of recurrence, overall survival (breast-cancer specific and     non-breast cancer deaths) patient satisfaction and quality of life.   "
114076|NCT01792713|"     Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients     with skin alterations associated with atopic dermatitis   "
114077|NCT01792700|"     patients who had failed previous H. pylori eradication on standard triple therapy were     randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate     bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)     (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg     b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were     performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and     culture). In patients who maintained continuous H. pylori negativity for the first year after     eradication therapy, H. pylori status was assessed every year. For the evaluation of risk     factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or     intestinal metaplasia were analyzed.   "
114078|NCT01792687|"     This is a Phase Ib, open label study of ARN-509 administered in combination with abiraterone     acetate and prednisone in patients with metastatic castration-resistant prostate cancer.   "
114079|NCT01792674|"     Care for pregnant is a field where unexpected emergencies occur, however emergencies are rare     and hence competences difficult to learn. Therefore, it can be relevant to use     simulation-based medical education. Many questions on how simulation can optimise learning     remain unanswered. A major question is how simulation settings as 'in situ simulation' (i.e.     in the actual patient care unit) versus 'off site simulation' (i.e. in training rooms or     simulation center) impact learning.      Objectives: To study the effect of 'in situ simulation' versus 'off site simulation' on     learning outcome, safety-attitudes, team performance and clinical performance in the     simulated setting plus stress and motivational inducing effect of simulation settings.      Design: Randomised trial. Primary outcome: Written knowledge-test. Exploratory outcomes:     Safety Attitudes Questionnaire, team- and clinical performance score, validated stress     inventory, salivary cortisol, Intrinsic Motivation Inventory and questionnaire on perceptions     of the simulation and organisational changes needed.      Perspective: To provide new knowledge on contextual effects of different simulation settings.   "
114080|NCT01792661|"     The study's purpose is to address the challenges of providing stage-appropriate chronic     kidney disease (CKD) education and care by developing innovative programs using a CKD Patient     Navigator system and an EHR (electronic health record)-based enhanced electronic     communication system specific for a CKD patient and her/his physicians/caregivers. The     investigators plan a randomized controlled trial of these innovations to examine the utility     and effectiveness of these special interventions.      The investigators' CKD registry aids in identifying patients for recruitment for the     randomized control trial. Patients are randomized into one of four groups. The four groups     are: 1) the control group using MyChart; 2) an enhanced personal health record (PHR) included     in MyChart consisting of 35 websites chosen to disseminate CKD stage-specific goals of care     and CKD education; 3) the patient navigator, a lay professional trained in the specifics of     chronic kidney disease navigation with a focus on the needs of their patients based on the     National Kidney Foundation Disease Outcomes Quality Initiative; 4) the patient navigator     combined with the enhanced MyChart.      The investigators hypothesize that a CKD Patient Navigator program will develop a more     prepared, proactive patient-caregiver team than usual care; the enhanced PHR will produce a     more informed, engaged patient than usual care; the CKD Patient Navigator arm and enhanced     PHR will demonstrate a slower rate of decline in eGFR (glomerular filtration rate) than usual     care.      The results of this study will lay the foundation for a larger multi-center national clinical     trial that will build upon the feasibility and knowledge gained from this planning grant.   "
114081|NCT01792648|"     Metabolic syndrome includes a cluster of cardiovascular disease (CVD) risk factors including     insulin resistance, abdominal obesity, high blood pressure and an atherogenic lipoprotein     phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of     small LDL particles. While lifestyle intervention remains the cornerstone for its management,     the optimal dietary macronutrient distribution for improving blood lipids and CVD risk     remains a topic of controversy. While both low carbohydrate diets and weight reduction are     effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes     imperative to identify alternative dietary approaches.      Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that     predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has     been demonstrated in patients with diabetes, there have been no trials in non-diabetic     patients with metabolic syndrome. Moreover, there is limited information of the effects of     almond intake on LDL particle subclasses.      The overall objective of the present study is to determine whether lipoprotein measures of     CVD risk in individuals with the metabolic syndrome are reduced by almond supplementation in     a diet with overall macronutrient content that conforms to current guidelines. Our main     hypothesis is that in these individuals, almond consumption can reduce levels of small and     medium LDL particles without the need to restrict dietary carbohydrates to levels below those     currently recommended.      This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented     diet (20%E) with those of two reference diets that do not contain almond products: one with     similar content of carbohydrate, protein, and fat (standard reference), and the other in     which carbohydrate content is reduced by substitution of protein and monounsaturated fat     (low-carbohydrate reference).      We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40     individuals with atherogenic dyslipidemia of the metabolic syndrome. We will test whether the     almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk,     specifically LDL-C and small and medium LDL particles, compared to either the standard or     low-carbohydrate reference diets.   "
114082|NCT01792635|"     This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of     oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.   "
114083|NCT01792622|"     Develop a brief, new, patient reported outcome instrument that is valid for use in clinical     practice and clinical trials.   "
114087|NCT01792570|"     Clinical approach to HIV infection treatment is based on the use of highly active     antiretroviral therapies (HAART) and recent national and international guidelines for guiding     HIV therapy recommend the use of triple-combination therapy using antiretrovirals with 2     nucleos(t)ide inhibitors [N(n)RTI] as backbone plus a third drug to be chosen among a boosted     protease inhibitor (PI/r), a nonnucleoside inhibitor (NNRTI) or an integrase inhibitor (II).      In spite of evident efficacy of HAART, as demonstrated by survival increasing, long term side     effects, as for example the impact on renal function, remain principal problem.      In patient with risk factor for renal disease, a reduction of eGRF (estimated Glomerular     Filtration Rate) between 90 and 60 mL/min/1,73 m2 could be already considered as a risk     condition [1,2].      Efficacy of HAART, with increase of media survival and the parallel decrease of mortality,     has underlined the necessity to reflect on long term HAART effects [3].      There are many evidences of HAART-related toxicity that, in spite of the necessity of a     life-saving therapy, focus on the additional costs of this situation, in terms of health as     well as in terms of economic costs.      Particular attention has been focused on the impact of some drugs on renal function, as     tenofovir, especially on tubule, without forgetting the modification of lipid and bone     metabolisms.      According to further studies which have evidenced the potential of some recently introduced     molecules [4,5], the investigators had the need to realize a study to deepen the feasibility     of a dual-therapy that permit to exclude NRTIs from the backbone, with the aim to prevent     NRTIs-related long-term toxicity.      The investigators have designed a prospective randomized controlled trial, open-label, with a     duration of 96 weeks, to compare the efficacy of a dual-therapy based on rilpivirine 25mg     plus darunavir 800mg/ritonavir 100mg QD, in HIV-positive subjects with suppressed viremia     from at least 3 months. In fact, there are a few data about association of these drugs, which     it has been shown to be safe, well tolerated, and with a strong pharmacological synergy,     without nucleos(t)idic backbone, while the necessity to minimize the costs toxicity-related     is becoming increasingly compelling.      According to clinical experience and literature data, the investigators hope this study shows     positive results in term of immune-virological efficacy, as well as in term of decrease of     VACS index - a complex parameter which has the purpose to quantify general organic decay -     and markers of lipid and bone metabolism, in group which receives dual-therapy versus the     group with standard therapy.   "
114088|NCT01792557|"     Although surgical techniques such as limberg flap. modified limberg flap and karydakis are     currently most popular treatment methods for pilonidal disease, crystallized phenol     application is also successfully used for pilonidal sinus treatment by different centers. We     believe crystallized phenol application could become a good alternative to popular surgical     interventions using transposition flaps.   "
114089|NCT01792544|"     This study examines the impact of adding a statement to the echocardiography report that     advises anyone reading the report regarding if and when a follow-up study is recommended.   "
114090|NCT01792531|"     Obesity has been shown to be resistant to treatment in adults, adolescents, and in school age     children, but not during early childhood. Yet knowledge on the effectiveness of early     childhood treatment programs for obesity is still very limited, preventing the widespread     implementation of such programs. The overarching purpose of this study is to evaluate the     effectiveness of early treatment of childhood obesity. The investigators plan to perform a     carefully-designed randomized controlled trial that will evaluate different treatment options     offered to families with children with obesity, organized within the healthcare system and     followed up for at least 1 year post-baseline. Participants will be children aged 4-6 years     (N=180) with obesity and their parents. This study will facilitate a close examination of key     treatment components and mechanisms of change. Results from this study will lead to better     healthcare options for obesity treatment during childhood and ultimately to the prevention of     obesity later in life from a public health perspective.   "
114091|NCT01792518|"     Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of     treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24     weeks of treatment.   "
114092|NCT01792505|"     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis     carries with it a median survival of approximately 24 months. The current standard treatment     of surgical resection followed by radiation therapy and chemotherapy has not substantially     prolonged survival and even the few treatment options shown to exhibit small increases in     survival primarily benefit certain (i.e., young) patient subpopulations.      Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body     to recognize the tumor cells are foreign and produce its own response to fight off recurring     tumor cells. A promising means of causing an immune response so the body can create this     immunity is through the use of dendritic cell (DC) vaccines.   "
114093|NCT01792492|"     This study will investigate the usefulness of an optical probe in the differentiation of     thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.   "
114094|NCT01792479|"     The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with     advanced non-small cell lung cancer (NSCLC).   "
114095|NCT01792466|"     Endoscopic cholangiography is a procedure which is performed to image the bile duct and     perform therapy like removal of bile duct stones. It is currently standard of care to remove     stones from the bile duct when found as they frequently cause complications like infections     which can sometime be life threatening.      Therapy on the biliary tree, like for example stone removal, frequently requires inserting     tools through the opening of the duct and cutting of the muscle which control the secretion     of juices from the liver. Cutting the muscle helps with securing an easy access to the bile     duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire     in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening     is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the     pancreatic duct facilitates placing a second wire in the bile duct possibly because it     straightens the duct. On certain occasions this also fails and we resort to cutting the     muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile     duct. The more attempt to enter the bile duct the higher the risk of inflammation in the     pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the     wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is     to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle.     This often cuts the bile duct sphincter and exposes the bile duct opening. The study is     trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct     immediately after a wire has entered the pancreatic duct will make it easier to place the     wire in the bile duct as compared to trying to place the wire in the bile duct without     cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated     attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting     the pancreatic muscle will facilitate entry to the bile duct and decrease the number of     attempts at entering the bile duct then it might be a better way to approach the patient whom     we had difficulty in entering the bile duct.   "
114096|NCT01792453|"     The GI MRI Research group at the University of Nottingham has been developing new,     non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.     The investigators now want to characterise; in collaboration with the College of Pharmacy at     the University of Michigan, the fasting volumes of gastric and small bowel liquid and their     time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral     solid dosage forms testing.   "
114097|NCT01792440|"     Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The     investigators' aim was to study the relevance of clinical parameters in terms of underlying     disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis     bronchiectasis population.   "
114339|NCT01789255|"     This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate     works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients     with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an effective     treatment for GVHD caused by a bone marrow transplant.   "
114104|NCT01792349|"     There is good evidence of the effectiveness of regular physical activity in the primary and     secondary prevention of stroke. STARFISH is a smartphone-based application designed as a     behavioural change intervention to encourage the user to become more physically active. The     study will investigate if using STARFISH for 6 weeks can increase physical activity in people     after stroke. Subjects will be randomised to the STARFISH intervention or a control group.     Control subjects will not have access to their daily activity count.   "
114105|NCT01792336|"     Background:        -  The brain has natural electrical rhythms of brain activities. These rhythms may be          different in people with movement disorders, such as dystonia (involuntary muscle          movement, cramps, or tremors). Understanding these rhythms may provide more information          about movement disorders.        -  Focal hand dystonia, also known as writer's cramp or musician's cramp, is a painful          condition that affects the hand and arm muscles. Researchers want to use transcranial          magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand          dystonia.      Objectives:      - To better understand brain rhythms involved in focal hand dystonia.      Eligibility:        -  Individuals between 18 and 70 years of age who are right-handed and have focal hand          dystonia.        -  Healthy right-handed volunteers between 18 and 60 years of age.      Design:        -  Participants will be screened with a physical exam and medical history.        -  This study includes two tests: a pilot test and a main test. The pilot test will          determine the frequency of TMS that will be used in the main test. Participants may be          in one or both tests. Each test requires a single outpatient visit that will last up to          5 hours.        -  Participants will have a base test to see how their muscles respond to TMS. This will          look at the electrical activity of the muscles. Participants will have a wire coil held          on their scalp. A brief electrical current will pass through the coil. It creates a          magnetic pulse that stimulates the brain. Researchers will test the TMS on the right and          left sides of the head. This will help find the spot that activates the finger muscles,          and see how much TMS is needed.        -  In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated          magnetic pulses delivered in short bursts. There will be four pulses in each burst.          Participants will have multiple bursts during the test. This test will look at how the          muscles of the hand and fingers respond to brain stimulation.        -  Treatment for focal hand dystonia will not be provided as part of this study.   "
114106|NCT01792323|"     To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at     high rates over a short period of time (bolus delivery). The length of this period (bolus     duration) usually depends on the chosen bolus size and on the used insulin pump model. This     study will evaluate the impact of different bolus durations (i.e., durations commonly     employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of     insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin     analogue.      Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics     of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different     bolus durations.      Study design: Single-center, randomized, controlled, two-arm cross-over intervention study      Population: Twenty type 1 diabetic subjects      Intervention: The investigational treatment is the subcutaneous administration of insulin     lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a     period of 10 min. Plasma samples to assess pharmacodynamic and pharmacokinetic properties     will be taken during an 8-hour clamp experiment. Patients will undergo both investigational     treatments in a randomized order; between the two clamp visits there will be a wash-out     period of 5-21 days.      Main study endpoint: Time to maximum glucose infusion rate   "
114107|NCT01792310|"     This is a phase 1/2A, open label, non-randomized study in patients with advanced solid     tumours including malignant glioma   "
114108|NCT01792297|"     Bovine colostrum is the initial milk secreted by cows during the first day after calving.     Colostrum is high in protein and contains a number of substances that have potential to be     beneficial for the immune system. Preliminary studies about effects of colostrum     supplementation show its potential for increasing human exercise performance; however, more     evidence across the lifespan is required to confirm effects and to understand mechanisms of     action. The objectives are to determine the effect of 8 weeks of bovine colostrum     supplementation, compared to whey protein supplementation on the following dependent     variables in men and women 50 years and older while participating in a resistance-training     program:        -  muscle mass        -  strength        -  blood levels of growth factors and markers of inflammation        -  urine levels of muscle and bone catabolic markers        -  tests of cognitive ability It is hypothesized that bovine colostrum supplementation will          result in greater increases in muscle mass, strength, blood IGF-1 levels (an anabolic          hormone), and cognitive ability, and greater reductions in inflammation, and markers of          muscle and bone catabolism, compared to placebo.   "
114109|NCT01792284|"     The primary purpose of participation in this study is to compare the safety and efficacy of     different dosing schedules of LY2605541 and how different dosing schedules of LY2605541     affect Hemoglobin A1c (HbA1c). Participants will be treated for up to 36 weeks with LY2605541     (one 12-week Lead-in period and two 12-week Randomization periods) and 42 weeks total study     enrollment (10 day screening period and 4 week Follow-up period).   "
114227|NCT01790711|"     The gut microbiota is considered to constitute a microbial organ which has pivotal roles in     the body's metabolism. Evidence from animal and human studies strongly support the link     between intestinal bacteria and type 2 diabetes mellitus. The present clinical trial aims to     re-establish a gut functionality state of intestinal flora through fecal microbiota     transplantation.   "
114110|NCT01792271|"     The purpose of this research study is to examine the effects of two weeks of daily dosing of     inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and     cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary     Disease (COPD.      Defective mucociliary clearance (MCC) is central to the development and/or worsening of     several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis (CF),     and bronchiectasis. In each case, defective MCC leads to the development of lung infections     and damage to the airways from ongoing inflammation caused by a person's inability to clear     mucus from the lungs.      The investigators' previous studies have shown that the administration of inhaled HS     (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use     resets the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of     HS on MCC was responsible for the ~60% reduction in the frequency of pulmonary disease     exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS     in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and     its success raises optimism that similar benefits might occur in patients with CB.      In this study the investigators will use mildly radioactive particles, technetium bound to     sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks     of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects with     CB. We will also be collecting sputum and breath condensation to analyze for protein and     inflammatory changes that might occur with exacerbations.      Our long term goals are to improve our understanding of MCC in health and disease and to     develop better therapies that support and/or restore MCC in patients with these diseases to     reduce lung infections.   "
114206|NCT01790997|"     This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3     months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome     in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active     controls.   "
114111|NCT01792258|"     Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current     literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged     weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper     airway obstruction. Many studies have focused on the comparison between different PDT     techniques and complication. The aim of our study is to evaluate the procedural features,     complications, ICU mortality, quality of life, post-discharge mortality of patients     undergoing different PDT techniques performed in ICU.   "
114112|NCT01792245|"     Hand psoriasis/eczema is a common problem which is characterized by itchy, erythematous and     scaly lesions often with a long lasting and relapsing course. Treatment is difficult with     considerable number of patients do not or only partially respond to the current treatments.     Several studies have shown the therapeutic effectiveness of the combination of topical     psoralen with long wavelength ultraviolet A radiation (PUVA) in treating hand     psoriasis/eczema. Topical PUVA is has several short- and long-term side effects. Narrow band     ultraviolet B (NB-UVB) has emerged recently as an important treatment for a variety of     photoresponsive diseases including psoriasis and eczema. For most conditions (other than hand     psoriasis/eczema) NB-UVB has been shown to have similar therapeutic results to PUVA with less     side effects. There are only a few studies published on the efficacy of NB-UVB for hand     psoriasis/eczema. Therefore, this study is aimed at comparing the efficacy and safety of     t-PUVA and NB-UVB in treating these conditions.   "
114113|NCT01792232|"     The investigators are investigating the effects of combined exposures to diesel exhaust and     allergens on lung function and on the immune system. After exposing individuals to either     filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The     investigators will use a procedure called bronchoscopy (whereby a thin, flexible tube is     passed down the throat and into the lungs) to place a small amount of allergen directly in     the lung. 48h later, the bronchoscopy will be repeated so that samples can be collected from     the lungs. After 1mo, the entire procedure will be repeated with the alternate exposure.   "
114114|NCT01792219|"     Title: The effectiveness of learning to collaborate interprofessionally on healthcare     processes and outcomes in nursing homes: a cluster randomized controlled trial in primary     care.      The ageing of the population is expected to be a major driver of increasing demand for more     complex and continuous care. The delivery of health care for this population requires high     level of coordinated teamwork and efforts. Interprofessional collaboration can improve     healthcare processes and outcomes. It assumes a model of working together. It is a process by     which professionals develop an integrated and cohesive answer to the needs of the patients.     In this study the possible effects of learning to interprofessionally collaborate will be     investigated on health care processes and outcomes for chronic geriatric patients in nursing     homes.   "
114115|NCT01792206|"     The purpose of this research study is to study the effects of paricalcitol on endothelial     function and inflammation, cardiovascular risk factors which are associated with patient     populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).      Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and     impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute     to atherogenesis.      Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative     stress and inflammation and improve endothelial function and thus contribute to an     anti-atherogenic action.   "
114116|NCT01792193|"     In previous work, the investigators analyzed the concentration of gut-derived peptides     (ghrelin, pancreatic polypeptide [PP]) in serum of patients with Parkinson's disease (PD).     The investigators have shown that the secretion pattern differs between PD patients and     controls. Beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g.     Glucagon-like-Peptide 1[GLP-1], Amylin, etc.) might be relevant for PD as well. The rational     to investigate gut-derived peptides in the neurological disorder Parkinson's disease (PD) is     based on the following considerations:        -  Receptors for gut-derived peptides are expressed in Central Nervous System (CNS)          structures that are affected by the neurodegenerative process underlying Parkinson's          disease        -  Gut-derived peptides are involved in the modulation of higher brain functions (mood,          cognition, reward-related behaviour) that are frequently altered in Parkinson's disease.        -  The secretion of gut peptides is (co-)regulated by the vagal nerve that is dysfunctional          in Parkinson's disease.        -  Certain gut-derived peptides (ghrelin, GLP-1) stimulate neurogenesis and might be able          to prevent cell death in neurodegenerative disorders, including Parkinson's disease.      Objective:      Collection of CSF and serum samples in a standardized way in order to quantitatively measure     the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic     peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions:        1. Do CSF (and serum) concentrations of these gut peptides differ between PD patients and          controls?        2. Do CSF (and serum) concentrations of the investigated peptides correlate with clinical          and / or epidemiological characteristics of the investigated subjects (age, gender, BMI,          disease duration, severity of motor impairments, presence of non-motor symptoms,          co-morbidities, medication, etc.)?   "
114117|NCT01792180|"     The Senior Step Study investigates whether feedback given by a mobility feedback device in     combination with an instruction book containing every day exercises, motivates elderly to     exercise more. By exercising more participants take charge of their own mobility and fall     risk. Senior Step Study studies whether this 'exercising more' positively affects their     mobility, fall risk, mental wellbeing, self-management, and quality of life.   "
114195|NCT01791140|"     This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in     combination with fluoropyrimidine-based chemotherapy in elderly patients (>/= 65 years of     age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until     disease progression, death, withdrawal of consent, discontinuation of physician-patient     relationship or study closure, whichever comes first.   "
114170|NCT01791465|"     This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide     extended-release formulation) on blood sugar levels and serum markers of inflammation in a     cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated     diabetes mellitus. Previous studies have shown that high levels of persistent systemic     inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected     persons on cART (a group at very high risk of atherosclerosis and myocardial infarction).     Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV     infected persons, which suggests that this agent may represent a unique and preferred     medication for the treatment of insulin resistance in HIV-infected adults. The Investigators     hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance     and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and     highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the     development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated     adults.   "
114118|NCT01792167|"     This study is a large-scale, randomized longitudinal evaluation of Second Step: Student     Success Through Prevention (Second Step - SSTP), a middle school intervention (Committee for     Children, 2008), which targets the shared underlying risk and protective factors for     bullying, sexual harassment, and dating aggression. This program is unique in its emphasis on     the role of peer group norms, attitudes, and behavior in the initiation and maintenance of     bullying and other forms of violence. Because of this, this investigation will involve a     direct test via social network analysis the extent to which peer norms or shifts in peer     attitudes are impacted by the intervention. Bullying is conceptualized as including verbal,     physical, relational, and cyber-aggression. Sexual violence is conceptualized as including     sexual harassment, sexual coercion in dating relationships, and homophobic teasing.     Thirty-six schools were drawn from four school districts in Illinois and one large district     in Wichita, Kansas and randomly assigned to Second Step - SSTP or a control condition. Second     Step -SSTP program draws from the risk/protective factors model and social-cognitive theories     of aggression. Lessons focus on the outcomes of bullying, relational aggression, sexual     harassment, dating relationships, and substance use. Risk factors targeted include     inappropriate classroom behavior, favorable attitudes toward aggression and substance abuse,     deviant peer affiliation, peer rejection, and impulsiveness are targeted as risk factors.     Targeted protective factors include empathy, problem-solving skills, school connectedness,     assertiveness and adoption of conventional norms. The P3R: Stories of Us - Bullying program,     composed of a series of film-based education will be used in the control schools. All 6th     graders at each school will be recruited and followed for the three year study period.     Students and teachers will complete self-report and nomination tasks. Growth curve analysis     via hierarchical linear modeling (HLM; Bryk & Raudenbush, 1992) will be utilized to assess     change in the major dependent variables (bullying, sexual harassment perpetration, dating     aggression), structural equation modeling will test for mediators across the study period,     and social network analysis will be instrumental in identifying peer norms and attitudes.   "
114119|NCT01792154|"     Assess changes in the corneal cell count using Specular Microscopy following tretments with     Anti-VEGF injections   "
114120|NCT01792141|"     The use of Indocyanine green diagnostic dye will identify areas of vascular leakage which     will provide more effective laser treatment by targeting these specific areas.   "
114122|NCT01792102|"     This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to     evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib     for patients with progressive multiple myeloma.   "
114123|NCT01792089|"     8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months     post-bypass, and 8 subjects matched to the post-bypass patients will be studied after     ingestion of two or three different of the following test-meals: A)cream and whey protein     B)cream, whey protein and fructose + 13C6 fructose C)test meal with cream, whey protein,     fructose and glucose + 13C6 fructose Their intestinal de novo lipogenesis will be estimated     by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48     in blood   "
114124|NCT01792063|"     In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity     rapid inhalation induction.   "
114125|NCT01792050|"     The purpose of this study is to compare the effects, good and/or bad, of standard of care     therapy (docetaxel or paclitaxel) with or without the addition of 1-Methyl-D-tryptophan     (referred to as indoximod) an experimental drug to find out which treatment is better.   "
114126|NCT01792037|"     we aim to evaluate the effects of single dose of etomidate or use of steroid prior to     etomidate during emergency intubation on hemodynamics and adrenal cortex.   "
114127|NCT01792024|"     This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial     thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense,     narrow beams of light to cut and destroy tissue and may help treat prostate cancer   "
114128|NCT01792011|"     The aim of this study is to compare the accuracy of PVI (pleth variability index)   "
114129|NCT01791998|"     This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial     thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image     guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the     tumor cells without affecting the surrounding tissue   "
114130|NCT01791985|"     This study is looking at a new drug called AZD4547 which is being tested for the treatment of     oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically blocks     proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes     that help cancer cells to grow. These proteins may also be responsible for the development of     resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet     approved for use in breast cancer and is therefore being used in this study as a research     drug.      The investigators will also test the theory that it is not necessary for high levels of FGFR1     to be present in the body to see benefit from AZD4547. (Stage 1 only)   "
114131|NCT01791972|"     The primary objective of this study is to evaluate the efficacy of a single dose (2     inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in     patients with EIB.   "
114132|NCT01791959|"     To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory     factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50     patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be     randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will     be advised to adherence our diet and exercise program too. At the first and the end of the     intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis     will be assessed and compared between groups.   "
114133|NCT01791946|"     The primary objective of this study is to assess the effectiveness of an investigational     binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy     eye, or poor vision in one eye due to a present or former eye misalignment). Patients will be     randomized to receive the study treatment either before or after strabismus surgery (i.e.,     corrective eye alignment surgery) or sham treatment before surgery. The study hypothesis is     that there will be no significant change in vision in neither the pre nor post-surgery groups     and no significant change in vision in neither the sham nor actual treatment groups.   "
114134|NCT01791933|"     The purpose of this study is to investigate the effect of CAM treatments consisting of herbal     medicine, Chuna manual therapy, pharmacoacupuncture, acupuncture on lumbar and cervical spine     pain patients due to spinal disease.   "
114135|NCT01791920|"     To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to     severe glabellar lines.   "
114182|NCT01791309|"     The purpose of this study is to test a new drug combination consisting of two drugs,     vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). This     treatment is being tested in a subgroup of patients with colorectal cancer whose tumors have     changes in the BRAF gene that may make them more likely to respond to this new drug     combination.   "
114136|NCT01791907|"     Type 1 diabetes (T1DM) is a chronic disease that affects approximately 10% of all diabetes     patients in the world. Diabetes a serious disease in which life expectancy is reduced,     largely due to increased mortality from kidney disease and cardiovascular (CVD) disease. Poor     glycemic control also results in eye and nerve damage, and psychosocial stress. Good     metabolic control, e.g. normalized hemoglobin levels (HbA1c) and normal blood lipids, reduces     the risk of eye, kidney, nerve, and vascular damage. Proper nutrition can normalize blood     sugar levels, improve blood lipids and prolong life in people with diabetes, according to     Swedish Council on Health Technology Assessment (SBU).      Dietary treatment is therefore seen as pivotal in the treatment of diabetes. This project     aims to evaluate two methods of structured training in patients with type 1 diabetes:        1. A structured education in carbohydrate counting, a course inspired by the DAFNE program          (Dose Adjustment For Normal Eating)        2. A new, structured education for heart healthy food choices and low glycemic index in          type 1 diabetes. The education is called My Wellness-LADDER (Lifelong Adult Diet &          Diabetes Education Resource) and it is specifically designed to provide high long-term          adherence through improved empowerment and transformative life style change.      The methods are compared with regular routine (control group).      This is a randomized controlled trial with three intervention groups 1) Healthy food choices     with a low glycemic index, 2) carbohydrate counting, and 3) regular routine. Follow‐up period     is 1 year. Eight Swedish specialist clinics are participating and 24 patients at each clinic     are to be enrolled.      The hypotheses is that structured group education on heart healthy food choices and low     glycemic index provide the same improvement in glycemic control and quality of life as     advanced carbohydrate counting in T1DM, as compared to regular routine. An additional     hypotheses is that structured education on healthy food choices and low glycemic index leads     to larger CVD risk factor reductions in T1DM compared to carbohydrate counting and regular     routine and that structured education on healthy food choices and low glycemic index lead to     more heart healthy food choices in T1DM compared to carbohydrate counting and regular     routine. Lastly, the hypotheses is that structured education on healthy food choices and low     glycemic index lead is more cost effective in T1DM compared to carbohydrate counting and     regular routine.   "
114137|NCT01791894|"     This pilot clinical trial studies arsenic trioxide in treating patients with basal cell     carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stop them from dividing   "
114138|NCT01791881|"     To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against     Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA   "
114139|NCT01791868|"     Study Hypothesis Generalized Convulsive Status Epilepticus (GCSE) is a medical emergency     associated with an increased morbidity and a prolonged length of hospital stay. Only 50% of     patients are discharged from the hospital within the first month after GCSE. Recent     Guidelines from Experts highlight the necessity to improve the efficiency of the first line     anti-epileptic (AE) therapy.      Intravenous Sodium Valproate (SV) might be an adjuvant AE drug to the recommended first line     AEs. Intravenous SV is available, well tolerated and easily injectible but also has     pharmacologic properties for reducing the risk of seizures relapses and for being     neuroprotective. However, efficacy of intravenous as an adjuvant therapy in GCSE has never     been properly assessed.      Primary Purpose The primary purpose is to assess if the association of intravenous Sodium     Valproate with the recommended treatment for Generalized Convulsive Status Epilepticus     increases to 20 % the number of living patients, discharged from the hospital at day 15.   "
114140|NCT01791855|"     Patients with renal impairment are the target population for PF-04634817. The clearance     mechanism of this drug means that exposure may be increased in subjects with renal     impairment. This study will investigate the effect of the drug in subjects with varying     degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.   "
114141|NCT01791842|"     Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small     proportion of patients fail to respond adequately. Mutated bone cells produce large amounts     of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may     be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a     placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can     reduce bone resorption in those patients with fibrous dysplasia who have already received     bisphosphonates.   "
114142|NCT01791829|"     This is a multicentre, single-arm prospective cohort study evaluating risk of ipsilateral     breast tumour recurrence(IBTR) following breast conserving surgery (BCS) in a group of women     postulated to be at low risk for recurrence. Women with luminal A breast cancer determined by     immunohistochemical(IHC) and other low risk clinical testing (see below) will be treated with     endocrine therapy (tamoxifen or aromatase inhibitor) for five years and will not be treated     with breast irradiation (BI). Subjects will be followed for 10 years and will be assessed for     recurrent disease, new primary cancer and survival.   "
114143|NCT01791816|"     Vasovagal Syncope (simple postural faint) is the most common cause of acute loss of     consciousness. Postural tachycardia syndrome(POTS) is the most common chronic form of     postural lightheadedness. Together they afflict many Americans, mostly young women, who are     prevented from gainful employ or school attendance. The underlying mechanism is not known.     Our past work suggests that a simple molecule, nitric oxide, acts to subvert normal blood     flow controls causing blood to pool in the gut when standing. Our proposal will show the     mechanism behind this problem and will indicate effective medical treatments. Patients will     be compared to healthy control subjects.   "
114144|NCT01791803|"     Smoking-related cardiopulmonary diseases account for a large number of hospital admissions.     We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking     cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks     after hospital discharge. We compared outcomes with hospitalized patients who received more     conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on     their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization     among patients admitted with a cardiac or a pulmonary diagnosis.   "
114196|NCT01791127|"     The objective of the SIELLO study is to demonstrate the safety and effectiveness of the     BIOTRONIK Siello S pacing lead.   "
114145|NCT01791790|"     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity     typically occuring during SWS has been implicated in the consolidation effect. Recent     evidence in young healthy subjects suggest that the sleep-associated consolidation effect can     be amplified by the application of a weak transcranial oscillatory electric current within     the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If elderly, healthy subjects     benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well     has not been studied so far. The primary aim of the present study is to investigate the     influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory     consolidation applied during periods of nocturnal SWS in elderly healthy subjects.   "
114149|NCT01791738|"     The proposed study is a double-blinded randomized controlled trial comparing patient specific     instruments with solely standardized instruments and pre-operative planning used for the     placement of the acetabular cup prosthesis used in total hip arthroplasty.      The investigators will enroll 36 patients who have consented to total hip arthroplasty for     treatment of hip pathology. This treatment is a standard of care. Patients will receive     standard of care pre- and post-operative care and placement of standard of care implants all     of which are commercially available and FDA approved for general use for the clinical     indications used in these patients. All patients will receive a pre-operative CT scan for     surgical planning and comparison with post-operative CT scan. The difference in intervention     between the groups will be the creation and use of patient specific instruments from the     pre-operative planning session. These instruments will be used for placement of an indexing     peripheral guide wire to direct acetabular preparation and placement of the shell assisting     standard surgical instruments. Print-offs from the pre-operative plan will also be used in     the treatment group.      The post-operative scan will be performed within two weeks of the surgery for both the     treatment and control groups. The investigators will analyze the difference in acetabular     shell placement (acetabular version and abduction angle) from the pre-operatively planned CT     scan. These differences will be compared between the control and experimental groups.   "
114150|NCT01791725|"     This is a prospective, randomized, double-blind, placebo-controlled, parallel-group,     three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks.     This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without     dementia.   "
114151|NCT01791712|"     Following the concept of peak concentration hypothesis, which suggest the cutting peak of     pro- and anti-inflammatory mediators would result in restoring a situation of     immunohomeostasis. The investigators conducted the prospective randomized controlled trial     aimed to compare the clearance efficacy between on-line hemodiafiltration and high-flux     hemodialysis in sepsis-related acute kidney injury patients. The lowering cytokines level     during sepsis is postulated to improved outcomes in sepsis.   "
114152|NCT01791699|"     Hypothesis: Modulation of central nervous sympathetic activation by administration of     moxonidine, a centrally acting medication which decreases the sympathetic nervous system     activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment     with pulmonary vein isolation.   "
114153|NCT01791686|"     This study is evaluating the study drug (CDX-1135) in patients with dense deposit disease     (DDD). The objective is to evaluate the safety and activity of repeated doses of CDX-1135 in     pediatric and adult patients with DDD. After screening, eligible patients will be entered     into the Induction Period. The Induction Period is up to 4 weeks. Following normalization of     complement activity, patients will enter into the Maintenance Period.The total treatment     duration is up to 26 weeks.   "
114154|NCT01791673|"     The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation     using HIFU in glaucoma patients   "
114155|NCT01791660|"     Protocol is intended for the clinical evaluation of fat reduction in male breasts     (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system     has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the     flanks, and is commercially available.      Primary study endpoint is changes in the shape and reduction of the fat in the breast as     established by photographic imaging and ultrasound imaging of the treated area.      Secondary endpoints will provide supportive data to evaluate device performance (subject     satisfaction & fat reduction measured with ultrasound).   "
114156|NCT01791647|"     The aim of this study is to compare the effects of six months treatment of two     insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women     affected by polycystic ovary syndrome. The study group includes 40 patients, randomly     allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day).     The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays,     oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline     and after six months of treatment.   "
114157|NCT01791634|"     Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and Visual     Analogue Scale of adult patients with moderate to severe hallux valgus with increased     intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus     the proximal chevron osteotomy?   "
114158|NCT01791621|"     Irritable bowel syndrome (IBS) sufferers often find that specific foods can exacerbate their     symptoms; identifying which foods involves a long and arduous process. Different food allergy     tests are marketed to IBS sufferers and healthcare practitioners as an easy way to identify     these offending foods. Which test method might be best to use? This project compares the     results of different food allergy methods versus an elimination/challenge diet to determine     which method maybe superior in IBS sufferers.   "
114159|NCT01791608|"     Acute respiratory infection and acute diarrhea are among the most prevalent diseases of     childhood increase the burden of morbidity and mortality in children under 5 years.      Among the possible strategies for its prevention is important to count on good nutritional     status for use in developing a good immune response to infections. Zinc deficiency has been     shown to favor the development of infections and has been considered a real public health     problem.      Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that     has shown evidence of being better absorbed and tolerated.      We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in     the prevention of acute diarrheal disease and acute respiratory infection.   "
114183|NCT01791296|"     Specific Aims        1. Establish the feasibility of larger trial by implementing a sleep protocol in the ICU at          2 different sites. Specifically will be estimating the recruitment rates of patients and          the compliance with both interventions.        2. Measure the safety and tolerance of adding night-time sedation with dexmedetomidine          using adverse effects and withdrawal rates as indicators.        3. Measure the effect of nocturnal dexmedetomidine on pertinent clinical outcomes and use          this outcome data to plan a larger, multicenter trial in this area.      The goal of this study is to determine whether a night-time protocol that incorporates a     pharmacologic intervention associated with improved sleep (i.e. dexmedetomidine) will improve     sleep quality and reduce the incidence of delirium and sub-syndromal delirium in critically     ill patients.   "
114160|NCT01791595|"     The main aims of this clinical study are to find out the maximum dose that can be given     safely to patients, the potential side effects of the drug and how they can be managed and     what happens to AZD3965 inside the body.      AZD3965 is a type of drug called a monocarboxylate transporter 1 inhibitor which is being     used to stop the growth of cancer cells and kill cancer cells by blocking the action of one     of the proteins involved in moving chemical compounds in and out of the cells of the body.     This will be the first time that this type of drug has been given to patients.      The drug is a capsule and is taken daily. The study is in two parts. In Part 1, small groups     of patients will be treated at increasing doses to find the highest safe dose and best dose     to give to patients in Part 2 of the study. Approximately 18 patients with advanced solid     tumours or lymphomas will be treated in this part.      In Part 2, the dose found to be safe in Part 1 will be given to three groups of patients with     either prostate cancer, gastric cancer or diffuse large B cell lymphoma. 15 patients will be     treated in each group.      Patients will need to visit the hospital weekly for two months and then every fortnight.     Patients will have regular blood and urine tests, scans, heart traces and eye tests amongst     other clinical tests. Research blood samples will also be taken to look at what happens to     the drug inside the body. Treatment will continue until a patient's cancer starts growing but     can continue for up to a maximum of 12 months if the cancer is responding to the drug. It is     important to explain that this is the first study of this drug and patients will have     advanced cancer so it is unlikely that patients will benefit directly from taking part but     the study may help improve future treatment of cancer.   "
114161|NCT01791582|"     To assess performance of resp rate parameter in a monitoring system PCBA-1   "
114162|NCT01791569|"     To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications     when the sensor is removed from the finger.   "
114163|NCT01791556|"     The study is funded through the Office of the Global AIDS Coordinator (OGAC #KE-07-0044). The     purpose of this study is two-fold. The first purpose is to see if routine monitoring of the     level of HIV virus in the blood (viral load) every six months is superior to monitoring by     standard clinical evaluations and or immune status (CD4 count) with intermittent viral load     monitoring in adults receiving antiretroviral therapy (ART). The second purpose is to     understand the cost implications and possible benefits of routine HIV viral load monitoring.   "
114164|NCT01791543|"     The purpose of the study is to assess the effectiveness and safety of a new device called an     Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and     ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This     approach is desirable because some people have ventricular arrhythmias that originate deep     within the heart muscle where it is not abolished by ablation with standard catheters.      The investigators seek to determine whether the INA catheter can potentially help people who     have ventricular arrhythmias that have failed standard radiofrequency ablation. The     investigators also want to determine if it is likely to be safe, without excessive side     effects.   "
114165|NCT01791530|"     Justification and background Ventilator-associated complications (VACs) are those     complications that develop during a period of intubation of a patient . Pneumonia is the     second most frequent infectious complication in the hospital, and ranks first in ICU, whose     risk is increased more than 20 times by the presence of invasive mechanical ventilation and     is called ventilator-associated pneumonia (VAP) . Whereas the information published regarding     VAP in terms of diagnosis, treatment and impact on the outcome of critically ill patients is     enormous.Ventilator-associated tracheobronchitis (VAT) incidence is lacking and complicated     in part, since the definition remains controversial. In addition, the significance of     tracheobronchial colonization as a risk factor for subsequent lower respiratory tract     infection remains unclear . The upper and lower airways can become colonized . Several     factors have been taken into account and do not differ from those involved in VAT and VAP     development in patients under mechanical ventilation.      Definition VAT diagnosis is controversial and represents an actual problem in order to define     the real incidence of VAT , There is currently no valid, reliable definition for VAT, and     even the most widely-used VAT criteria and definitions are neither sensitive nor specific.     The diagnosis of VAT is considered when a patient under invasive mechanical ventilation     starts with fever, leukocytosis and new or increased purulent secretions by the endotracheal     tube. A particular difficulty with much commonly used VAT definition (in order to distinguish     from VAP) is the key point of the absence of pulmonary consolidation. Evidence suggests that     chest radiograph findings do not accurately role out VAP. A taskforce on hospital-acquired     pneumonia, and VAP has been recently published (European Respiratory Society (ERS), European     Society of Clinical Microbiology and Infectious Diseases (ESCMID) and European Society of     Intensive Care Medicine (ESICM)). Nosocomial tracheobronchitis definition includes occurrence     of purulent tracheal secretion after ≥48 h of hospitalisation or mechanical ventilation plus     ≥2 of the following: fever (≥38.5°C) or hypothermia (<36°C), leukocytosis (≥12 × 109/L),     significant bacteriologic counts in respiratory secretions (≥103 cfu/mL for protected brush     specimen (PBS) and ≥105 cfu/mL for endotracheal aspirates); absence of new pulmonary     infiltrates compatible with pneumonia and absence of other causes of fever are mandatory.     This definition needs to be further validated and can overdiagnose the incidence of VAT (and     overuse of antibiotics) because the positive culture of respiratory secretions is not a     mandatory item RATIONALE Given the possible high incidence of VAT, and its importance as a     risk factor for VAP, and a potential target to treat in order to reduce VAP incidence, a     large multicentre   "
114166|NCT01791517|"     The purpose of this study is to evaluate the clinical and laboratory performance of three     brand name contact lenses with three recently introduced multipurpose lens care solutions     (test solutions) as well as a peroxide disinfecting solution (control solution).   "
114167|NCT01791504|"     The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and     effective alternative to drains(standard of care) for fluid management following     abdominoplasty. It is hypothesized that the use of the Cohera device will facilitate     reduction or closure of dead space when applied to planar surfaces created during an     abdominoplasty procedure.   "
114169|NCT01791478|"     This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when     given together with letrozole in treating patients with hormone receptor-positive metastatic     breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some     of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast     cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719     together with letrozole may kill more tumor cells   "
114184|NCT01791283|"     Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform     analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac     magnetic resonance imaging (CMRI)   "
114185|NCT01791270|"     To describe the relationship between OSA and clinical Hypertension (performing ABPM),     endothelial dysfunction (performing flowmetry), and its relation at the basic research     (determining the β1 subunit in Peripheral Leukocytes in peripheral blood). This relation     between OSA and HTA has been evaluated in basal conditions and after modifying the     pathophysiological role of OSA applying treatment with positive continues pressure (CPAP)     during 3 months.   "
114171|NCT01791452|"     Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence     estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic     heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to     90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients     are of especial practical and theoretical importance. Cholesterol Ester Storage Disease     (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a     deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in tissues     and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with varying     degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and     isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is poorly     understood, the investigators propose to evaluating the association between NAFLD and LAL     deficiency in a prospective study in our population.   "
114172|NCT01791439|"     The investigators wish to determine if application of 2% lidocaine soaked gauze to the     peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope     assisted tracheal intubation in the morbidly obese.   "
114173|NCT01791426|"     The objective of this investigation is to show that the performance of Artelac Rebalance eye     drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry     eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment     administered 3 to 5 times per day.   "
114174|NCT01791413|"     The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot     medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic     cystectomy.   "
114175|NCT01791400|"     The purpose of this study is to determine which drug makes lower migraine headache   "
114176|NCT01791387|"     The main purpose of this study is to find out how useful dovitinib is when given as the     initial treatment to participants with advanced kidney cancer, that has spread to other parts     of the body. The usefulness of dovitinib will be assessed by: how long the disease is     controlled while participants are receiving the drug, the proportion of participants who get     a reduction in the size of their tumours and how long participants live (both while on     dovitinib and on any subsequent therapy they may receive).      If participants have secondary disease in the bones, the study will evaluate how useful     dovitinib is in controlling this site of disease. In addition, this study will look for     changes in the genetic makeup of tumour cells and see if some of these changes are associated     with a benefit from dovitinib. The study will also compare and contrast the genetic changes     in the primary tumour cells with cells from secondary tumour specimens, and with cells from     tumour specimens taken if a participant's disease has worsened. The purpose of the latter is     to identify possible ways in which the tumour becomes resistant to the study drug.   "
114177|NCT01791374|"     This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced     solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.   "
114178|NCT01791361|"     This non-interventional retrospective medical record review study will assess the prevalence     of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in     patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European     countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation     testing, this study will also assess data from the laboratory that performed the KRAS test.     The study will also monitor changes in the pattern of Vectibix treatment between the     different rounds of the study.   "
114179|NCT01791348|"     The d2 test of attention has been used in studies regarding sleep deprivation due to night     shifts in hospital staff, in order to determine whether sleep deprivation has an impact on     performance. However, by repeating the test there appears to be a test-retest effect, as the     participants improve when performing the test more than once. The aim of this study is to     determine, whether the d2 test of attention has a test-retest effect.   "
114194|NCT01791153|"     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will     evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will     consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week     open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants     will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or     placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52,     participants in remission will stop study treatment and enter long-term follow-up, whereas     participants with disease activity or flares will receive open-label tocilizumab or other     treatment at the discretion of the investigator for a maximum period of 104 weeks.   "
114340|NCT01789242|"     This is a dose finding study to evaluate the safety and determine the maximum tolerated dose     of carfilzomib in patients with previously treated systemic light-chain amyloidosis.   "
114180|NCT01791335|"     Noninvasive ventilation (NIV) can provide ventilatory support in selected patients with acute     respiratory failure, for instance due to acute exacerbation of COPD and acute heart failure.     Advantages of noninvasive ventilation compared to invasive mechanical ventilation include     absence of complications associated with endotracheal intubation, lower risk of pneumonia,     lower level or even absence of sedation and the ability of the patient to verbally     communicate. However, in approximately 30% of patients NIV fails and endotracheal intubation     is needed to provide optimal ventilatory support. Surprisingly, very few studies have     investigated why patients fail on NIV. Clinical observations indicated that agitation,     delirium and most importantly asynchrony between patient and ventilator play a role in     unsuccessful support with NIV. The upper airways are bypassed during endotracheal intubation.     However, with NIV the upper airways may play a role in the efficiency of ventilatory support.     In normal breathing the upper airways actively dilate before initiation of inspiratory flow.     This is a highly appropriate response as it prevents narrowing of the upper airways during     inspiration, which would result in elevated inspiratory resistance. Experiments in newborn     lambs have shown that NIV has profound effects on physiology of the upper airways. Positive     pressure during inspiration results in constriction of upper airway muscles in the early     phase of inspiration. This results in elevated upper airway resistance with lower tidal     volume delivered to the lungs. Subsequent studies revealed that reflexes that mediate this     response originate in vagal afferences located in the lower airways. From an evolutionary     point of view this might be an appropriate response, as high pressure delivered to the lungs     may induce barotraumas. However, these responses may negatively affect the efficiency of     ventilatory support delivered during NIV. The understanding of upper airway constriction and     dilation during NIV is rudimentary. This study aims at determining the effect of NIV on     regulation of upper airway patency in patients with COPD.   "
114181|NCT01791322|"     NovellusDx is developing a diagnostic platform for the personalized cancer therapy based on     patient derived tumor tissue. The assay is able to sense activating mutations by monitoring     their effect on a chip-based device.   "
114186|NCT01791257|"     The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from     patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.   "
114189|NCT01791218|"     A substantial proportion of patients undergoing elective coronary artery bypass grafting have     a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse     short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be     effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with     coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination     of them. Procedure is well defined and safe.      There is a lack of convincing evidence of the effect on postoperative atrial fibrillation     burden, quality of life and symptoms especially in correlation with atrial fibrillation     paroxysms.   "
114190|NCT01791205|"     This is a multicenter observational study in patients with rheumatoid arthritis in routine     clinical practice in Italy. In the retrospective Part 1 of the study, clinical and     demographic factors associated with the use of a biologic drug in monotherapy as compared to     therapy in combination with Disease-modifying anti-rheumatic drugs (DMARDs) will be     evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the     use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be     followed for up to18 months.   "
114191|NCT01791192|"     This study will assess the safety, tolerability, and efficacy of FTY720 in patients with     acute, noninfectious intermediate, posterior and pan uveitis   "
114192|NCT01791179|"     Substance abuse is highly prevalent among individuals with HIV and associated with negative     outcomes including poorer medication adherence and HIV risk behavior. The primary aim of this     project is to address substance abuse among individuals with or at high-risk for HIV by     enhancing and expanding the substance abuse services provided in the formerly Substance Abuse     and Mental Health Services Administration (SAMHSA) funded Carolinas Alcohol and Drug     Expansion Team (CADET) program, which offered comprehensive substance abuse care for     individuals with HIV living primarily in the Durham NC area. Services will be enhanced by     adding peer outreach and navigation services to improve treatment engagement and     participation and expanded to replicate the enhanced CADET service model in Charlotte NC.      The target population for this project is minority individuals, primarily African-Americans,     with HIV or at high-risk for HIV with a particular focus on minority men who have sex with     men (MSM)s. The program will provide up to 18 months of comprehensive services for     approximately 315 individuals and will include: 1) peer outreach to facilitate and enhance     treatment engagement 2) individual and group substance abuse treatment using evidence-based     models 3) ongoing recovery groups for individuals who have completed the intensive substance     abuse treatment phase and 4) linkage to needed services such as case management, psychiatric     care, and HIV/Hepatitis medical care. We will also target HIV and Hepatitis C testing and     treatment services for minority MSM of unknown HIV status to increase access and utilization     of substance use services and identify HIV and Hepatitis status.      The study evaluation will involve analysis of participant survey data gathered at baseline,     6, 12, 18 months of study participation to determine the effect of the comprehensive     substance abuse care services on outcomes for individuals with HIV including substance use,     mental health, HIV treatment adherence, HIV risk behavior, and access and utilization of HIV     services. The study will also determine the effect of the comprehensive substance use program     on substance abuse, mental health, and risk behavior outcomes for minority MSM who are not     HIV-positive.   "
114197|NCT01791114|"     Recent findings document the presence of active brown adipose tissue (BAT) in humans. Cold     exposure via adrenergic stimulation activates BAT, which combusts significant amounts of     blood glucose and free fatty acid (FFA) to produce heat. Animal studies suggest that BAT     activation improves insulin sensitivity. However, the effect of cold-induced BAT activation     on insulin sensitivity and glucose kinetics in humans remains unknown. The investigators'     central hypothesis is that cold-induced BAT activation increases whole body insulin     sensitivity in humans via augmented plasma glucose and FFA clearance. The specific aims of     this study are to define the effects of prolonged (8h) cold exposure BAT activation on:     insulin sensitivity (Aim 1); lipolysis and plasma glucose and FFA kinetics (Aim 2); on     thermoregulation (Aim 3). Moreover, the investigators plan to investigate for alternative     ways, which can activate BAT including cold water ingestion, a single meal ingestion, and a     single bout of moderate intensity exercise (Aim 4). For the cold exposure study, subjects     will complete 3 trials: a) 8hrs of cold exposure at their individually determined shivering     threshold; b) 8hrs of cold exposure at their individually determined shivering threshold plus     propranolol; c) 8hrs in thermoneutral conditions (26 - 28°C). For the rest of the arms of     subjects will complete two trials: cold or tepid water ingestion, a single meal ingestion or     no food ingestion, and a single bout of moderate intensity exercise or no exercise.To study     the above aims, the investigators will use positron emission tomography - computed     tomography, hyperinsulinemic euglycemic clamp, infusion of stable isotopes, and tissue     biopsies. The findings will illuminate the role of BAT on plasma substrate regulation and     insulin sensitivity and may aid in the development of lifestyle recommendations and     pharmacotherapy for the prevention and treatment of diabetes and insulin resistance.   "
114199|NCT01791088|"     This clinical trial studies sirolimus in treating patients with solid tumors that are     metastatic or cannot be removed by surgery. Sirolimus may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth   "
114200|NCT01791075|"     The purpose of this study is to compare the Tan EndoGlide with the new Endoserter injector in     terms of damage to the donor corneal endothelium by comparing the endothelial cell loss at 1     month, 3 months, 6 months, and 1 year post DSAEK (Descemet's Stripping Automated Endothelial     Keratoplasty)surgery. There is no data comparing this two injectors.   "
114201|NCT01791062|"     The two-layer bioresorbable HYTOP® matrix consists of an upper layer of highly purified     porcine splint-skin which contains natural pores, and a lower layer of highly purified     collagen fleece containing hyaluronan (HA).      In this study, the medical device will be used and evaluated in a one-step procedure     combining microfracturing with surgical implantation of HYTOP®. HYTOP® will support     haemostasis in the articular cartilage defect, act as a support for cell growth and as a     three-dimensional scaffold for cell differentiation. HYTOP® will protect the underlying     tissue after cartilage debridement and/or microfracturing of the subchondral bone.      The primary working hypothesis is that HYTOP® is safe and suitable as a cell-free matrix to     support haemostasis, as a cover for the cartilage lesion and eventually to enhance cartilage     regeneration in a one-step surgical procedure.   "
114202|NCT01791049|"     TD-1607, administered intravenously as single doses, will be investigated in healthy subjects     to assess its tolerability, safety, and pharmacokinetics.   "
114203|NCT01791036|"     Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL     reconstruction surgery, yet result in less motor blockade than a femoral block.   "
114204|NCT01791023|"     Depressive elderly individuals have showed higher basal level of cortisol and lower level of     dehydroepiandrosterone (DHEA). Moreover, changes on these hormone levels have also observed     in reactivity of an acute stress, such as physical exercise. On the other hand, physical     training can modulate the release of these hormones. Therefore, depressive elderly     individuals physically actives might show attenuated reactivity of an acute physical stressor     compared to sedentary elderly individuals. The aim of these study is to compare the effect of     an acute physical stressor on cortisol levels in depressive and healthy individuals,     physically actives and sedentaries. Additionally, the sulfated form of DHEA (DHEAS) serves as     a reservoir for DHEA, because of that it is expected that DHEAS levels might reduce after the     acute physical exercise.   "
114205|NCT01791010|"     Aging causes anatomical and physiological changes in the respiratory system and respiratory     muscle strength with decline in its maximum function. This study aimed to evaluate the     effects of inspiratory muscle training on respiratory muscle strength, thickness of the     diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that     inspiratory muscle training improves respiratory muscle strength, the thickness of the     diaphragm and diaphragmatic mobility in older women.   "
114207|NCT01790984|"     The hypothesis of this study is that a diet high in sugars will increase abnormalities in     blood lipids which are associated with increased cardiovascular disease risk, relative to a     diet which is low in sugar. We predict that this potentially adverse effect of dietary sugars     on blood lipids will be more pronounced in people with a raised level of stored fat inside     their liver, as compared to people with a low level of stored fat.   "
114208|NCT01790971|"     Patients with Obstructive Sleep Apnea (OSA) appear to be especially vulnerable to medications     that suppress pharyngeal muscle activity such as general anesthetics and opioids. Opioids can     depress the ventilator response to airway obstruction and inhibit the awakening response to     hypoxia and hypercarbia, resulting in central respiratory depression. OSA is therefore an     important risk factor for serious postoperative complications, including perioperative death.     While OSA is increasingly recognized as a serious perioperative concern, current clinical     practices are highly inconsistent with regard to the management of surgical patients with     OSA. Additionally, the relative safety of intrathecal opioids in this patient population     remains unknown.   "
114209|NCT01790958|"     Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve     retinal function.   "
114211|NCT01790932|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug to learn whether the drug works in treating a     specific cancer. Investigational means that the drug is still being studied and that     research doctors are trying to find out more about it-such as the safest dose to use, the     side effects it may cause, and if the drug is effective for treating different types of     cancer. It also means that the FDA has not yet approved BKM120 for use in patients, including     people with your type of cancer.      BKM120 is a drug that works by blocking a protein called PI3K which may contribute to cancer     growth. This drug has been used in experiments in the laboratory and information from these     research studies suggests that BKM120 may help to prevent cancer cells from growing.      In this research study, the investigators are looking to see if BKM120 works to stop breast     cancer cells from growing.   "
114212|NCT01790919|"     Existing drug and talking therapies for major depressive disorder (MDD) fail to produce     complete recovery. This study will determine if substantial improvements to one of the most     promising therapies, cognitive therapy (CT), can be achieved by administering a carefully     designed procedure to improve memory for the content of CT sessions. This is important     because (a) memory deficits are common in MDD patients and (b) each CT therapy session     typically covers a complex array of topics and various skills are taught.   "
114213|NCT01790906|"     To study whether renal sympathetic denervation(RSD) RSD can slow the progression of CHF and     reduce the rate of all-cause mortality effectively and securely.   "
114214|NCT01790893|"     The purpose of this study is to monitor safety outcomes for patients being treated with     intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed     Ocular Histoplasmosis Syndrome.   "
114215|NCT01790880|"     The purpose of this study is to evaluate whether a computerized speech-language treatment     delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing)     results in improved written communication skills of study participants with aphasia (i.e.,     difficulty with the comprehension and expression of spoken and written language).   "
114216|NCT01790854|"     Aim: to verify if after the acute phase of ACS acute coronary syndrome (1-months), from 1 to     12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mg/day may reduce     the bleeding events (5 mg vs 10 mg). All patients will be treated with 325 mg of aspirin     followed by a maintenance dosage of 100 mg of aspirin for at least 1 year. At baseline (after     60 mg loading dose of prasugrel) and after 1 month (7 days after the randomization at 10 or 5     mg of prasugrel) all patients will undergo light transmittance aggregometry (LTA) test to     evaluate residual platelet reactivity (pharmacodynamic effects).   "
114217|NCT01790841|"     The purpose of the study is to proof the safety and efficacy of the new ICD sytem     (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is     set on the ICD system with DF4 connection.   "
114218|NCT01790828|"     This study is to describe the safety and efficacy of Xyntha® during the usual care setting.   "
114219|NCT01790815|"     PRIMARY OBJECTIVE :      To determine whether mothers, given minimal group training, are capable of using a MUAC     (mid-upper arm circumference) bracelet to screen their children for malnutrition and     categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow'     (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status)      SECONDARY OBJECTIVES :      To establish whether there is a difference in the MUAC value if measured on the right arm as     opposed to the left, in young children      To determine whether there is a difference in the MUAC value if the mid upper arm position is     determined visually as opposed to being measured in the 'classical' fashion   "
114220|NCT01790802|"     The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the     progression to advanced age-related macular degeneration.   "
114221|NCT01790789|"     The purpose of this study is to investigate the effects of a stress reduction program on the     quality of life of ovarian cancer patients during primary adjuvant chemotherapy.   "
114222|NCT01790776|"     Conventional urethrography is the standard diagnostic evaluation for patients with a     suspicion of urethral stricture. The radiation dose of this examination is 5-9 mSV.     Sono-urethrography was introduced in 1988 (McAninch et al. , J Urol 1988); the diagnostic     accuracy of sono-urethrography is equal compared to conventional urethrography, with even a     better measurement of stricture length and degree of spongiofibrosis with sono-urethrography.     However, sono-urethrography remained underused among urologists and radiologists.      Patients will be randomly assigned into two groups:      Group A: conventional urethrography Group B: sono-urethrography In case sono-urethrography is     inconclusive or of poor quality, a conventional urethrography will be performed.      The radiation dose in the two groups will be measured. The stricture length and location will     be recorded and compared with the perioperative findings in order to evaluate the diagnostic     accuracy. The complications of the procedure(s) will be recorded with a questionnaire     directly after and two weeks after the conventional or sono-urethrography.   "
114223|NCT01790763|"     The purpose of this study is to determine the extent to which Keramatrix dressing promotes     the healing of second-degree burn wounds in pediatric patients.   "
114224|NCT01790750|"     This is a single-center, feasibility study involving all neonates admitted to the neonatal     intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and     provided a description of the study. No written consent will be requested, but parents have     the option of opting out. Each patient will have a 5 minute Pocket echocardiography system     scan followed by a full echo performed on a traditional full featured echo system. The     objective is to assess if the current Food and Drug administration (FDA) approved Pocket     echocardiography system (PES) can detect patent ductus arteriosus (PDA) in neonates as     comparable to traditional full featured echo systems (FFES) and/or physical exam alone.   "
114225|NCT01790737|"     The purpose of this study is to determinate the efficacy and safety of the 3-drug induction     treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized     autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide     maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized     mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony     stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.   "
114228|NCT01790698|"     This proposal focuses on highly lethal destructive tissue infections, i.e. necrotizing     fasciitis and other necrotizing soft tissue infections (NSTIs), which are associated with     high morbidity and mortality. The fulminant course of NSTIs demands immediate diagnosis and     adequate interventions in order to salvage lives and limbs. However, diagnosis and management     are difficult due to heterogeneity in clinical presentation, in co-morbidities and in     microbiological aetiology. Thus, there is an urgent need for novel diagnostics and     therapeutics in order to improve outcome of NSTIs. A comprehensive knowledge of diagnostic     features, causative microbial agent, treatment strategies, and pathogenic mechanisms (host     and bacterial disease traits and their underlying interaction network) is required for an     improved diagnosis and management of NSTIs. The current proposal is designed to obtain such     insights through an integrated systems biology approach in patients and experimental models.     The project is based on a prospective NSTI patients cohort including a clinical registry to     document clinical data and treatment strategies, combined with an isolate and biobank     collection. The samples will be analyzed through advanced bioinformatics and computational     modelling work flow to identify and quantify pathogen signatures and underlying networks that     contribute to disease outcome. One aim is to translate clinical and systems biology data into     development of novel diagnostics.   "
114229|NCT01790685|"     To measure the pro-permeability factors in the aqueous humor of patients with     persistent/recurrent macular edema after an injection of Ozurdex.   "
114230|NCT01790672|"     The study is aimed at establishing the contribution of wine components on hydroxytyrosol body     concentrations and biological effects.   "
114231|NCT01790659|"     This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing     the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in     subjects with CL in Panama. The primary objective of this study is to determine if WR 279,396     results in statistically superior final clinical cure rates of an index lesion when compared     with Paromomycin Alone for the treatment of CL in Panama expected to be caused by L     panamensis.   "
114232|NCT01790646|"     Glidescope laryngoscope was introduced as a novel tool for difficult intubation. Its learning     curve was prooved on manikin but not in adult patients.   "
114233|NCT01790633|"     This is a pilot, monocentric, prospective, randomized control trial looking at the use of     rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus     (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be     proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from     the organization Médecin du Monde (CASO, MDM).      Infection status of participants will be determined by either the standard test (ELISA) or     rapid test. The choice between tests will be determined randomly.      The overall goal is to determine the general acceptability and feasibility of rapid tests and     to see if they can help individuals increase their awareness of infection status when     compared to longer, routine methods of testing. In addition, results from these tests will     allow the medical doctor to guide participants to appropriate care. All positive tests will     be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and     health-specific information will be obtained four months after testing.   "
114234|NCT01790620|"     Severe septic patients with acute kidney injury (AKI) requiring continuous renal replacement     therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine     liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with     continuous venovenous hemofiltration (CVVH) presents frequent complications, known as     dialytrauma, and a high resource cost both technical and human. The study primary end-point     is to demonstrate a non-inferiority survival of continuous venovenous hemodialysis (CVVHD)     plus an adsorption membrane respect to CVVH plus an adsorption membrane. As secondary     end-points investigators will try to demonstrate immunomodulation and technical superiority     of CVVHD respect to CVVH. In order to achieve these objectives investigators have designed a     randomized controlled trial that will include those patients whom present severe sepsis and     AKI meeting CRRT initiation criteria. During the first 72 hours investigators will measure     plasmatic elimination capacity of main cytokines, lipopolysaccharide (LPS), and other     clinical and prognostic relevant molecules. Investigators will also measure hemodynamic,     respiratory, and metabolic parameters. Adverse effects related to CRRT (dialytrauma) will     also be registrated. Finally, investigators will analyze 90 days survival. Demonstration of a     non inferiority survival added to a superior immunomodulating capacity and a minor     complication rate with its consequent lower cost, should settle the based evidence principles     that recommend the use of CVVHD asociated to an adsorption membrane in severe septic patients     with AKI whom need CRRT.   "
114235|NCT01790607|"     To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with     the hepatic impairment and matched healthy subjects.   "
114236|NCT01790594|"     The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the     amount of other anti-rejection medications necessary and thereby reduce the long-term side     effects caused by the other medications. The researchers also want to learn more about the     safety of this treatment and long term health of transplanted pancreases and kidneys.   "
114244|NCT01790490|"     Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to     cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits.     Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators,     studies with human subjects have been unsuccessful to date. The purpose of this investigation     is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent     therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting     cocaine in cocaine dependent participants, 24-hours post-infusion.   "
114245|NCT01790477|"     The goal of this study is to assess the role of battlefield acupuncture in the reduction of     pain scores status post adult tonsillectomy. Secondary goals of this study include reduction     in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an     increased risk of worsening pain or improved response with acupuncture.   "
114298|NCT01789788|"     This randomized, double-blind, placebo-controlled, multiple ascending dose study will     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in     patients with type 2 diabetes mellitus. Patients will be randomized to receive either     RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the     last dose of study drug.   "
114237|NCT01790581|"     Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains     and other residual impairments. CAI has been linked to many different causative factors     including sensory and motor deficits that affect the global function of the sensorimotor     system as well as the patient. Over the past 20 years, strong evidence has been generated to     support balance training as an effective intervention strategy in the CAI population.     Unfortunately, most investigations have focused solely on maximizing motor output through     balance training, while ignoring the full spectrum of sensorimotor dysfunction associated     with CAI. There may be advantageous sensory-targeted interventions that augment the effects     of balance training and lead to greater enhancements of functional outcomes for CAI. However,     this possibility has not been systematically explored. Sensory-targeted ankle rehabilitation     strategies (STARS), such as joint mobilization and plantar massage have resulted in improved     sensorimotor function in those with CAI. However, only a single STARS (i.e. stochastic     resonance) has been investigated in combination with balance training. While the combined     effects were greater than those of balance training alone, stochastic resonance requires     relatively expensive equipment that is not commercially available. Thus, the purpose of this     investigation is to test the hypothesis that combining low cost STARS (e.g. plantar massage     and joint mobilizations) with balance training will result in greater sensorimotor and     functional improvements in those with CAI than balance training alone.   "
114238|NCT01790568|"     This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After     completing enrollment of the planned 12 subjects, we are extending the study to an additional     25 subjects. The trial will examine the safety and efficacy of the addition of vorinostat,     the study drug, to standard medications to try to prevent or lower the risk of graft     versus-host disease (GVHD) for recipients of unrelated (matched) donor, blood or marrow stem     cell transplants. The transplant regimens, chosen according to current institutional policy,     will depend upon the recipient's underlying disease (their blood cancer or other blood     disorder), previous therapy, and current health issues. GVHD prophylaxis (preventive drug     intervention) will be the local institutional standard for post-transplant immunosuppression,     including tacrolimus and methotrexate, plus vorinostat. Vorinostat will be given twice daily     orally beginning 10 days prior to the recipient's transplant and continue for up to 100 days     after transplant.   "
114239|NCT01790555|"     Adequate treatment of postsurgical pain leads to better mobilization, shorter hospital stay,     lower costs and higher patient satisfaction. In its treatment, frequent use is made of     opioids. However, opioids have many side-effects. A possible add-on can be sought in THC,     which has been shown to have possible analgesic and/or pain modulating effects in preclinical     research. The purpose of this study is to investigate the analgesic and pain modulating     effects of perioperative Namisol, a tablet containing THC, in patients that will undergo     major abdominal surgery.   "
114240|NCT01790542|"     With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6     months of age there has arisen concern about what is the best solid food to introduce at that     time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified     rice cereal was the first food of choice. New recommendations from Health Canada include meat     as a potential first food as well as other iron fortified foods. This has lead to uncertainty     of both public health officials and parents about the optimal introduction and choice of     solids after exclusive breastfeeding.      In addition to meeting iron needs with the first solid food choice, the investigators are     concerned about the possible generation of reactive oxygen species (ROS) in the gut of the     infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron     per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that     most of the residual iron enters the colon. Normally excess iron is sequestered by a variety     of mechanisms in the body, but there is no such system for the sequestering of iron in the     gut lumen. The investigators have shown that providing iron supplements to adults where the     majority of the iron is unabsorbed passes through the digestive tract can lead to the     generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day     supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will receive     the same dose and are likely producing ROS in their digestive tract. This may cause     inflammation and make infants more susceptible to disease. The investigators think that meats     and infant cereals with phenolic antioxidants available from fruits will likely reduce the     generation of ROS in vivo. Therefore the investigators wish to determine if traditional and     newly recommended first foods are safe from a free radical and inflammatory perspective.      HYPOTHESES:        1. Consumption of infant cereals with iron will increase ROS generation in the gut        2. Consumption of infant cereals with iron and fruit will decrease ROS in the gut        3. Consumption of meat will not generate ROS        4. Consumption of iron fortified cereals or meat will maintain iron status during infancy   "
114252|NCT01790386|"     This study is being performed to obtain data about the CORA system, a new device that is     currently being tested and is not yet cleared for sale in the United State by the Food and     Drug Administration (FDA). The purpose of the study is to validate the CORA system by     comparing the results of this test to that of the standard of care device called the TEG     system. Both systems evaluate hemostasis, a highly complex and interactive process involving     many protein and cellular elements, especially platelets, occurring in a series of     interrelated phases, which results in either normal hemostasis or a tendency toward bleeding     or clotting complications.   "
114306|NCT01789684|"     RATIONALE: Multi-faceted provider education and decision support intervention will increase     the rate of appropriate referral of breast cancer patients at increased risk for hereditary     breast and ovarian cancer (HBOC) to genetic counseling.      PURPOSE: This cluster randomized controlled trial will compare active and passive     interventions to increase the rate of appropriate genetic counseling referrals of newly     diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the     community oncology setting.   "
114241|NCT01790529|"     Surgical site infections (SSI) are the most frequent hospital acquired infections in patients     who underwent surgery. With regards to the increasing financial restraint in patient care,     the socio-economic burden of SSI in the public health sector and its prevention gains in     importance.      The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior     to the skin incision significantly reduces the risk of SSI, but the correct time point of     drug administration remains unclear. Most studies recommend application of SAP directly prior     to skin incision. Other studies, however, suggest that this is too late and more time between     administration of the SAP and skin incision is necessary for optimal SSI prevention. A large     cohort study in Switzerland concluded that SAP should be applied between 74 and 30 minutes     prior to skin incision.      Due to the obvious importance of this controversy, we want to answer this question with a     clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and the     Cantonal Hospital of Aarau. We plan to investigate two administration strategies according to     the timing of the SAP. Strategy A will consist of SAP application in the anesthetic room     located in front of the actual operating theatre, where the patient gets anesthesia.     Therefore, the application of SAP will take place early, approximately between 75 and 30     minutes prior to skin incision. In strategy B we will apply SAP in the operating theatre,     which on average occurs later (approximately within the last 30 minutes before skin     incision).      We test the hypothesis that strategy A is more effective in preventing SSI than strategy B.     We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at     each study site and 2500 per study group). All patients will be followed in the hospital for     SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital     discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such as     hip endoprosthesis or meshes). We expect this study to be completed within approximately 3     years.   "
114242|NCT01790516|"     This study is for patients with newly diagnosed head and neck cancer that cannot be removed     by surgery.      The purpose of this study is to determine the feasibility of using genetic variations in     patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab     (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with     radiation therapy. In this study the investigators will test whether genetic differences     between patients can be used to pick which of these two drugs a patient should receive. All     patients will have a blood sample drawn that will be tested for genetic differences. If     patients have genetic differences that correlate with a better outcome from cisplatin they     will receive cisplatin with radiation. If patients have genetic differences that do not     correlate with a better outcome from cisplatin they will receive cetuximab with their     radiation therapy.   "
114243|NCT01790503|"     The study objectives are to assess the potential for PLX3397 to improve the efficacy of     standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed     glioblastoma (GBM).   "
114246|NCT01790464|"     Endotracheal intubation of the morbidly obese is often performed awake. This is performed     after topical anesthesia of the patient's pharynx and larynx. There are many techniques used     to perform topical anesthesia of the patient's airway, which include aerosolization of local     anesthesia, topical application of local anesthesia, and nerve blockade using needles and     local anesthesia. Reasons for failure of any awake tracheal intubation technique is excess     gagging. The most effective method to adequately anesthetize the airway to decrease the     amount of gagging is unknown. The investigators wish to assess if the instillation of local     anesthesia soaked gauze next to the peritonsillar pillars will decrease the number of gagging     episodes during awake video laryngoscopy assisted tracheal intubation of the morbidly obese.   "
114247|NCT01790451|"     Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a     radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure     approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using     similar planning criteria, procedure protocol, instruments and software used for     brachytherapy, a conventional targeted radiation therapy where radioactive seeds are     implanted into prostate tumours. Patients will have an ultrasound of the prostate and the     imaging data will be entered into the Planning Software system. The volume of the prostate is     measured and a specified ablation zone will be determined. The IRE will be performed under     general anaesthetic and the specified zone identified in the planning stage will be ablated.     Four IRE electrode needles will be placed into the prostate under ultrasound image guidance.     When the needles are in place, electric pulses of one to two minutes duration are used to     ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data     will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre-     prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection     is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance     Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have     their scheduled prostatectomy at approximately 30 days after the IRE procedure.     Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS.     Post prostatectomy, efficacy of ablation will be determined by histological examination of     the prostate by the Pathology Department and measured as complete or incomplete ablation.      The primary outcome is safety as measured by the composite of procedural device and post     procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v     4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate     Symptom Score (IPSS) or required catheterization time and International Index of Erectile     Function (IIEF) and efficacy of ablation determined by histological examination post     prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient     satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS)     pain score, time to ambulation, length of hospital stay.   "
114248|NCT01790438|"     The purpose of this study is to compare LY2605541 and human insulin NPH using the following     measures for participants treated for up to 26 weeks:        -  Change in participants' overall blood sugar control        -  The number of night time low blood sugar episodes        -  The number of participants that reach blood sugar targets without low night time blood          sugar episodes        -  The total number of low blood sugar episodes reported   "
114249|NCT01790425|"     This is a prospective , single center, investigator initiated, randomized controlled trial to     compare two methods of performing colonoscopy by experienced colonoscopist. Potential female     subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and     will be enrolled if they sign the informed consent.      In recent years, the water infusion method has been reported to have several beneficial     effects when studied in veteran patients. These include: significant reduction in discomfort     to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled     unsedated colonoscopy, lower sedation medication requirement when they accepted the option of     minimal pre-medication sedation, more patients completing without sedation (78% vs 54%) when     they accepted the on demand sedation and an increase in the yield of adenomas (a type of     cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the method     have repeatedly called for studies using the method in female patients to confirm or refute     the findings as most of the veteran patients are male patients.   "
114250|NCT01790412|"     To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic     activities) aerobic and muscular tonification, on control to the prevention to Gestational     Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.   "
114251|NCT01790399|"     The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in     addition to the usual method (blue and /or radioactive product). This is a feasibility study   "
114307|NCT01789671|"     To evaluate the acceptability and feasibility of peers as interventionists in delivering     family-based behavioral pediatric weight control intervention.   "
114253|NCT01790373|"     The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative     intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple     intervention studies by our team in Rakai and Masaka Districts of southern Uganda with     AIDS-orphaned adolescents have revealed that if given an opportunity to participate in     economic empowerment interventions, youth and their caregivers take full advantage of these     interventions to save and invest in their future, show improvements in family financial     outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental     health. The Suubi+Adherence study capitalizes on this prior work, positing that economic     empowerment may be a missing, yet critical ingredient to HIV treatment adherence     interventions for adolescents and young people. Suubi+Adherence incorporates an economic     empowerment design, with a savings-led income generating component, to promote economic     stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents     in a region of southern Uganda with the highest HIV incidence and prevalence in the country.   "
114254|NCT01790360|"     The study will seek and recruit substance-using Black Men who have Sex with Men (MSM) in New     York City for Human Immunodeficiency Virus (HIV) testing and will link and retain those who     are HIV infected in HIV primary care. The STAR study has two primary objectives: to evaluate     the feasibility and effectiveness of Respondent Driven Sampling (RDS) in the substance using     Black MSM population for identifying individuals who are HIV infected and not in care; and to     assess the relative effectiveness of patient navigation and financial incentives in linkage     and retention to HIV care.   "
114255|NCT01790347|"     An estimated two-thirds to three- quarters of women experience gestational weight gain     outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30%     inadequate gain. Not gaining the adequate weight gain is strongly associated with several     maternal and fetal complications..   "
114256|NCT01790334|"     It is widely known that positive mechanical ventilation increases the positive intrathoracic     pressure which affects the pressure in the RIJV, resulting in an increase of the CSA.     Currently, there appears to be a lack of studies in the literature that assess the effects of     different modes of ventilation of this increase.      The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV     under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in     head neutral and 30 degree rotated lateral position by using ultrasonography and to determine     the ventilation mode that is most suitable for catheterization.   "
114257|NCT01790321|"     The general objective of this study is to determine the effect of the daily consumption of     zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school     age children from rural areas characterized by a high risk of zinc deficiency and by elevated     stunting prevalence.   "
114258|NCT01790308|"     The purpose of this study is to investigate and evaluate the effects of liraglutide combined     with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control     and β-cell function in newly diagnosed type 2 diabetic patients.   "
114259|NCT01790295|"     The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior     to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing     another person's hematopoietic stem cells (bone marrow transplantation) will be successful in     people who have advanced primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis     (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), collectively known as     myelofibrosis (MF). MF is a disorder in which bone marrow tissue develops in abnormal sites     because the bone marrow itself undergoes fibrosis or scarring. This study plans to evaluate     whether adding the drug Ruxolitinib will further aid in reducing pre-transplant spleen size,     improve physical performance levels and reduce adverse events (side effects) related to the     transplant. Ruxolitinib is a drug that is approved by the FDA for the treatment of patients     with advanced forms of myelofibrosis. Using Ruxolitinib prior to stem cell transplantation is     experimental.   "
114260|NCT01790282|"     Study if supporting luteal phase of high responder (high egg production or high Estradiol     level) long Gn_Rh agonist protocol ICSI/IVF cycle by combined Estradiol and progesterone     impairs or improves outcome in terms of pregnancy and implanation rates.   "
114261|NCT01790269|"     Data on fingolimod effects on NK cells are so far conflicting. A longitudinal study on     fingolimod treated kidney transplant patients showed that NK cells were not influenced in any     of the treatment groups. However, more recent reports indicate an increased frequency of NK     cells in peripheral blood and CSF of MS patients treated with fingolimod and a relative     reduction of immature CD56bright NK cells in fingolimod-treated MS patients. It has been     demonstrated that the expression of NK cell relevant sphingosine 1-phosphate (S1P) receptors     seems to increase during NK cell maturation. Thus, different NK cell sub-types may response     differently to S1P-receptor agonist such as fingolimod.      Therefore, the investigators aim to investigate longitudinally (baseline vs. treatment) the     effects of fingolimod on NK cell maturation/differentiation.   "
114262|NCT01790256|"     Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep     System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia     patients. The current study is a two dose study to determine the optimal temperature for the     Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and     sleep efficiency.   "
114263|NCT01790243|"     The purpose of the study is to collect additional safety and efficacy information on the     Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the     femoral and popliteal arteries.   "
114264|NCT01790230|"     A preliminary Study in Subjects Undergoing Low Anterior Resection   "
114265|NCT01790217|"     This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in     first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive     non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to     initiate treatment with Tarceva according to the local label will be followed for 18 months.   "
114308|NCT01789658|"     Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning     regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to     effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.   "
114266|NCT01790204|"     The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC),     a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53     protein's normal (wild-type) function within cells is to act as a tumor suppressor, or     anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions     of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed     clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since     the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral     cells will contain measurable levels of mutant p53. The participants will consume watercress     juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC     selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is     that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral     cells. This depletion could lead to a possible clinical application of this compound, such as     chemopreventives or oncologic treatments of individuals with oral cancers.   "
114267|NCT01790191|"     This study aims at comparing learning mechanisms to increase vegetable acceptance in infants     at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and     flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining     the impact of infants' feeding history on vegetable acceptance.   "
114268|NCT01790178|"     The objective of the proposed study is to evaluate the clinical utility of muscle     ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our     facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years     old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle     biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of     this test is important.   "
114269|NCT01790165|"     The aim of this study is to establish a clinical bridge to Lamisil® tablets by conducting a     clinical pharmacokinetic (PK) study comparing the systemic exposure of a Lamisil® tablet with     that of with TDT 067 under maximal use conditions.      Under maximal use conditions in onychomycotic subjects, the aim is to confirm that there are     significantly lower plasma levels of terbinafine and its major metabolites after a topical     administration of TDT 067 for 28 days in comparison with a single oral 250 mg Lamisil®     tablet.   "
114270|NCT01790152|"     This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated     with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in     the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more     about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand     how well patients respond to treatment.   "
114271|NCT01790139|"     To determine whether colonic bubbles associated with CT colonography performed with iohexol     for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic     preparation.   "
114272|NCT01790126|"     The proposed clinical trial will study the effects of 12 months of therapy with ARN-509     alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men     with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The     endpoints selected reflect measurable short term effects of androgen deprivation therapy     (ADT), including quality of life and several metabolic parameters. In addition, the relative     effect of each treatment strategy on PSA suppression as well as testosterone recovery (and     subsequent PSA progression) after 12 months of therapy will be evaluated.   "
114273|NCT01790113|"     A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of     Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a     degenerative joint disease.   "
114274|NCT01790100|"     The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally     administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C     infection.   "
114275|NCT01790087|"     This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the     effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac     repolarization, specifically, Fridericia's QT-Interval (QTcF)   "
114276|NCT01790074|"     It is a pilot randomized controlled trial comparing real and simulated manual treatment of     trigger points (TrPs) in patients with cervicogenic headache (CeH). The purpose of the     current randomized clinical pilot trial was to determine the preliminary effects of TrP     manual therapy in individuals with CeH with sternocleidomastoid muscle active TrPs as     compared to manual contact over the muscle tissues.   "
114277|NCT01790061|"     The gut microbiota is considered to constitute a microbial organ which has pivotal roles in     the intestinal diseases and body's metabolism. Evidence from animal and human studies     strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD).     Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis.     Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel     syndrome (IBS) and constipation have also met with some success. This is an initial step into     investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut     (at least below duodenal papilla) for UC, the investigators propose to determine the     efficiency and safety of FMT in a series of 60 patients with moderate to severe UC (Montreal     classification).   "
114278|NCT01790048|"     This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of     two supplementary foods in the treatment of MAM.      Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in     the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding     program.      Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will     differ by no more than three percent.   "
114279|NCT01790035|"     Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing     acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety     lead-in.   "
114280|NCT01790022|"     In this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain,     stiffness, joint pain and swelling) of active ankylosing spondylitis (AS) will be     investigated. It is expected, that a single dose of methylprednisolone 500 mg given     intravenously at baseline will lead to a rapid reduction of symptoms of active AS, which can     be seen already 2 weeks after drug administration.   "
114281|NCT01790009|"     Accumulating evidence suggests that regular consumption of foods and beverages rich in     flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several     well-controlled randomised human intervention studies have shown that cocoa flavanols have     beneficial effects on blood pressure, endothelial function and other biomarkers of     cardiovascular health. These vascular improvements have been correlated in time with changes     in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore     likely dependent on changes in their absorption, distribution, metabolism and excretion     (ADME). Recent studies have provided detailed information regarding the absorption and     metabolism of cocoa flavanols. However, there is a lack of information on whether there are     changes in flavanol absorption and metabolism with increasing age.   "
114282|NCT01789996|"     Two - four 6MWT performed according to ATS standards. Each walk however had specifically     altered wording and coaching performed in random order to determine differences in outcomes.     One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the     patient can walk. One was coached to walk at the patients normal walking pace. One was     coached to walk at the patient's leisure walking pace.   "
114283|NCT01789983|"     The study will look at conducting a medium-intense walking program called Walk With Ease with     cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how     many of these patients complete their participation in this program.   "
114284|NCT01789970|"     The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate     extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in     alleviating moderate to severe pain in patients with chronic low back pain. Patients may be     opioid-naïve or opioid-experienced.   "
114285|NCT01789957|"     This multicenter, open-label extension study of Protocol 2993-112 is designed to assess     long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate     long-term safety and tolerability in subjects treated with metformin who receive     subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing     Protocol 2993-112 are eligible to enroll.   "
114286|NCT01789944|"     To evaluate the acceptability and feasibility of peers as interventionists in delivering     family-based behavioral pediatric weight control intervention.   "
114287|NCT01789931|"     CB (Chemical Biological)protective clothing provides a thermal resistance between the human     body and its environment. CB protective clothing will be essential for combat soldiers in     case of non conventional attacks. Lifebeam developed a new non invasive sensor for body     core temperature detection. The research purpose is to evaluate the Lifebeam sensor during     heat tolerance test while wearing CB protective clothing.   "
114288|NCT01789918|"     The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to     include up to one hundred (100) eligible patients as defined within the clinical     investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally     designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.   "
114289|NCT01789905|"     To retrospectively collect the effectiveness and safety information of tigecycline related to     their appropriate use in daily practice.   "
114290|NCT01789892|"     The purpose of this study is to determine whether giving an anti-inflammatory medication     (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or     eliminate false findings related to inflammation   "
114291|NCT01789879|"     The use of hormone contraception poses a significant challenge for the estimated 16 million     HIV-infected women of childbearing age. This is due to known drug interactions with     antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception     effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel     subdermal implant, the most widely available hormone implant in low and middle-income     countries, this study will translate its findings into an evidence-based approach to     co-manage these important medications. The investigators hypothesize that women receiving     nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the     mean levonorgestrel plasma concentration measured six months after the implant's insertion as     compared to those women who are not taking antiretroviral therapy. Although the implant's     efficacy may be retained initially, the investigators propose that a decrease in     levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the     implant's effectiveness near the end of its intended duration of use (5 years).   "
114292|NCT01789866|"     Studies suggest that lutein and n-3 fatty acids may influence the development of a child's     brain and may be related to how well children learn. Both lutein and the n-3 fats (also known     as omega-3 fats) are not made by the body and must be obtained in the diet. The investigators     are interested to understand the importance of n-3 fats and lutein to child brain     development. Functional magnetic resonance imaging (fMRI) will make it possible to look into     the brain from the outside and see which parts of the brain are being used as children     complete working memory tasks. The investigators will study brain function using fMRI among     children with different intakes of n-3 fats and lutein.      Hypothesis:        1. Children 6 years of age consuming < 25 mg/day DHA and < 400 μg lutein/day will show          poorer activation of brain areas on fMRI than children consuming > 150 mg/day DHA and >          1,200 μg/day lutein.        2. Children consuming < 400 μg lutein/day and > 150 mg/day DHA will also show differences          in fMRI results when compared to children consuming > 150 mg/day DHA and > 1,200 μg/day          lutein.   "
114293|NCT01789853|"     The purpose of this study is to demonstrate the efficacy of intensive locomotor interventions     early post stroke. An intensive locomotor training (LT) program will be compared to an active     control, conventional physical therapy. It is proposed that an early and intensive stepping     paradigm that is not typically employed early in physical therapy will lead to superior     outcomes and improved community mobility. A randomized, blinded, controlled trial will test     subjects with moderate to severe locomotor dysfunction in individuals post-stroke to compare     walking-related outcomes after intensive gait training (including treadmill, overground,     stair training, and skilled walking training) to outcomes after conventional physical     therapy.   "
114294|NCT01789840|"     The purpose of this study is to evaluate improvement of symptoms from benign prostatic     hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for     prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional     transurethral resection of the prostate (TURP).   "
114295|NCT01789827|"     This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients     with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures,     such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a     scanner to make detailed pictures of areas inside the body and may be a less invasive way to     check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99     hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells     and may be able to differentiate between tumor growth due to inflammation versus tumor     progression in patients with stage IV melanoma receiving therapy.   "
114296|NCT01789814|"     Early stent thrombosis has been noted with increased frequency in acute coronary syndrome     (ACS) patients undergoing percutaneous coronary intervention (PCI) who are treated with     bivalirudin and clopidogrel. The brief half life of bivalirudin acting in concert with the     delayed action of clopidogrel likely exposes patients to thrombosis during a vulnerable     period of reduced antiplatelet effect in the immediate post stenting period. Combination     therapy with bivalirudin and prasugrel is conceptually attractive as the more rapid onset of     action of prasugrel could potentially significantly diminish the vulnerable period, likely     reducing the potential for acute stent thrombosis. The trials which have documented the     efficacy of prasugrel as compared to clopidogrel have, in general, not reported on patients     in whom bivalirudin was utilized. Currently, in the United States, bivalirudin is the most     commonly used adjunctive agent used during PCI. Using light transmission aggregometry, this     study will examine the inhibition of platelet aggregation in patients randomized to treatment     with clopidogrel vs prasugrel during the vulnerable period following the discontinuation of     bivalirudin therapy. The investigators anticipate that this study will document significant     enhancement of inhibition of platelet aggregation in patients randomized to prasugrel     treatment.   "
114297|NCT01789801|"     Previous studies have demonstrated that an experienced ultrasound operator is able to     efficiently perform radial arterial puncture on patients where an initial operator failed to     puncture arteries via simple palpation.      The objective of this study is to compare difficult-to-puncture patients randomized into     two groups: one group where ultrasound is used to aid artery localisation, and one group     where only palpation is used.   "
114300|NCT01789762|"     This study is a multicentre, double-blind, randomized therapeutic trial.      The primary objective of this study is to evaluate non-inferiority with regard to prevention     and control of haemorrhage:        -  of platelet concentrates treated by pathogen reduction(Intercept amotosalen and UVA          procedure)        -  compared with the usual platelet concentrates (in additive solution intersol), reference          arm, and        -  compared with platelet concentrates re-suspended in autologous plasma (historic arm)          These three products are available and authorised by ANSM (formerly AFSSAPS).      The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and     safety and the decreased frequency of grade 2 or higher side effects related to transfusion     allergy to platelets.   "
114301|NCT01789749|"     The purpose is to investigate whether a simple additional treatment applied during     colonoscopy (called 'soft' coagulation) can reduce the risk of recurrence of polyp at the     area where the polyp was removed. After a large polyp is removed it is known that there is a     20% chance that a small recurrence of polyp occurs at the site of removal can occur within 5     months of the polyp being removed. This in theory will burn off tiny polyp tissue, which is     usually not visible to the naked eye. This additional treatment may possibly reduce the risk     of polyp recurrence.   "
114302|NCT01789736|"     In the double-masked, randomized, multi-center, active-controlled parallel study, patients     will be randomized to receive either a fixed dose combination of AR-12286 and travoprost,     AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment     arm.   "
114303|NCT01789723|"     The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or     reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.   "
114304|NCT01789710|"     The purpose of this study is to examine the effectiveness of an internet-based contingency     management program for smoking cessation in persons who are homeless. Thirty homeless smokers     will be enrolled in the study. Participants will receive payment based on their own low     carbon monoxide readings, which indicate being quit from smoking. Participants will be     prescribed nicotine replacement (patches and either gum or lozenge)and bupropion. All     participants will receive a four sessions of smoking cessation counseling, and will be     trained to perform carbon monoxide monitoring with a device provided by the study. They will     also be provided with a mobile phone equipped with a video camera, and will use this     equipment at home to monitor their carbon monoxide . Participants will record videos of     themselves taking a carbon monoxide reading and displaying the results, and will upload the     videos to a secured website that is only accessible by the research team members and the     participant. Payment will be based on providing carbon monoxide readings that indicate     abstinence.      The study is designed to address the following aims:      Specific Aim 1: To evaluate whether it is feasible to use internet-based contingency     management for helping smokers who are homeless stop smoking.      Specific Aim 2: To evaluate how effective internet-based contingency managementis on     decreasing smoking in smokers who are homeless.   "
114305|NCT01789697|"     The objectives of this double-blind, randomized, controlled study are to evaluate the     efficacy of maintaining contact with low-back pain patients through text messaging and     emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging     and emailing, and to improve reporting of surgical site infection after spine surgery through     text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up     visits and received phone calls, and reporting signs of surgical site infection. Participants     will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at     Duke Raleigh Hospital. Patients will be approached after determination that the patient is     going to undergo spinal surgery. All patients meeting inclusion criteria will be approached     to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.   "
114321|NCT01789489|"     To prove that the 3 dimensional sonohysterography is, at least, as effective as the     diagnostic hysteroscopy in examining the uterine cavity.   "
120580|NCT01707602|"     The project aims to evaluate the impact of skin routes of immunization (transcutaneous and     intradermal vs intramuscular) on cellular and humoral responses to seasonal influenza     vaccination in adults (18-45 years old).   "
114309|NCT01789645|"     It is a randomized clinical trial comparing surgical and conservative (physical therapy)     treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to     determine the efficacy of physical therapy versus endoscopic surgery in pain and disability     in women with carpal tunnel syndrome at medium and long-term follow-up periods. We     hypothesized that proper physical therapy approach can be equally effective than surgical     intervention for improving pain and function in patients with carpal tunnel syndrome.   "
114310|NCT01789632|"     This Pilot study is a Multicenter, Randomized Trial comparing autologous platelet rich plasma     (PRP) versus autologous whole blood versus dry needle tendon fenestration on pain and quality     of life in patients with lateral epicondylitis (tennis elbow). We want to find out if pain     and mobility are improved in people who receive an injection of PRP compared to a group of     people who receive an injection of whole blood, a group treated with dry needle tendon     fenestration and a group of people who receive no injection.   "
114311|NCT01789619|"     To evaluate the clinical efficacy of the extended release formulation of tacrolimus     (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with     cyclosporine A because of side effects and/or non-responsiveness.   "
114312|NCT01789606|"     A self-selection and actual use trial to evaluate the extent to which consumers will     appropriately select and use the 600 mg immediate release/extended release caplets and comply     with dosing instructions.   "
114365|NCT01788917|"     The study was performed to investigate the effects of a daily consumption of linseed oil on     fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.   "
114313|NCT01789593|"     This trial is conducted in Europe. The aim of the trial is to compare cognitive function and     associated brain activation patterns during an acute hypoglycaemic episode and during     euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess     cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in     subjects with type 1 diabetes.   "
114314|NCT01789580|"     Prevalence of problem gambling is estimated about 1-3% of the general adult population. This     percentage increases to 5% when talking about online gambling. In France, the market for     online gambling was recently opened up to competition and regulation (May 2010), including     poker and sports/horse races betting, but excluding for the moment casino games. Recent     international studies show that legalizing online gambling led to an increase of practices,     including problem gambling.      In France, the law stipulates the establishment of moderators of online gambling, to prevent     excessive gambling practices. The Regulatory Authority of Online Games (ARJEL) guarantees the     implementation of these moderators. However, no evaluation of the effectiveness of these     moderators is planned.      Therefore the investigators propose to conduct an experimental study about online gambling.     The objective will be to evaluate the effectiveness of four kinds of moderators, some already     legislated, but not evaluated, and others offered by the investigators team. Proposals for     amending legislation will be made according the results of this study.   "
114315|NCT01789567|"     To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve     Implantation System via direct aortic approach.   "
114316|NCT01789554|"     Death from cardiac disease is one of the most common causes of death in the western world.     The majority of these deaths takes place outside hospital as sudden cardiac death. However,     with immediate (within minutes) actions such as cardiopulmonary resuscitation (CPR) and     defibrillation many lives would be saved. CPR is a key factor to increase survival from Out     of Hospital Cardiac Arrest (OHCA). CPR buys time by supporting the brain with some     circulation in waiting for a defibrillator that can restart the heart. In Sweden about 2,5     million people are trained in CPR. However, only about half of all OHCA victims will get CPR     in waiting for ambulance arrival.      The aims of the Response to Urgent Mobile message for Bystander Activation (RUMBA) trial is     to try a new way of logistics to increase bystander CPR by recruiting lay volunteers to     nearby OHCAs via their mobile phones.      Hypothesis: By dispatching lay volunteers to nearby OHCAs with mobile phone technology     bystander CPR may increase from 50% to 62,5 %   "
114317|NCT01789541|"     Overt hyperthyroidism (so-called goiter in lay language) is a hormonal disturbance that is     known to increase the risk of atrial fibrillation (a common heart arrhythmia with potentially     severe consequences) in some patients. Previous research has indicated that even slight     elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may increase     this risk. When atrial fibrillation and overt hyperthyroidism are found simultaneously in a     patient, the hormonal imbalance must be treated first in order to later resolve the     arrhythmia. It is unclear whether this strategy holds true for subclinical hyperthyroidism.     Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in patients admitted     for atrial fibrillation ablation than in the population as a whole, and 2) Patients with     subclinical hyperthyroidism and atrial fibrillation benefit less from ablation than others.      As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry     Tachycardia at the same clinics as the cases. No correlation has ever been shown between     AV-nodal Reentry Tachycardia and hyperthyroidism.   "
114318|NCT01789528|"     The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL     on the intestinal flora of male and female healthy volunteers after multiple administrations     over 7 days. An assessment of the effect on intestinal flora is an important aspect to     understand for the safe clinical use of the investigational products and is expected by     regulatory agencies.   "
114319|NCT01789515|"     In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is     common to create a diverting stoma at the same procedure. Several studies have shown that     ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and     postoperative complications after major colorectal surgery. The aim of this study is to     evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects     postoperative morbidity in patients treated within an ERAS program.   "
114320|NCT01789502|"     This study is a prospective, randomized study to compare of outcome of fully covered metal     stents with that of plastic stents for preoperative biliary drainage in distal common bile     duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of     stent-related adverse events, the re-intervention rate, the effectiveness of biliary     drainage, surgical outcomes and hospital stays.   "
114325|NCT01789437|"     to evaluate the wall-to-lumen ratio (WLR) of retinal arterioles in hypertensive patients with     retinal vein occlusion (RVO) before and after dexamethasone intravitreal implant 0.7 mg (DEX)     compared to a matched control group of normal eyes in non-hypertensive subjects.   "
114326|NCT01789424|"     Aim of this study is to evaluate swallowing functionality in patient sedated for     gastroenteric endoscopic procedure.      Swallowing will be study by laryngeal fibroscopy and evaluate using Penetration-Aspiration     Scale and Aspiration Risk validated in scientific literature.      Aim of the study is to describe swallowing, as an expression of airway protection, in sedated     patient. in particular, our purpose is to determine the incidence of moderate-severe and     severe swallowing alteration (level 3 or 4 of Aspiration Risk scale).   "
114327|NCT01789411|"     The AtheroRemo-IVUS study aims to investigate the relation of coronary plaque phenotype and     vulnerability as determined by intravascular ultrasound and near infrared spectroscopy with     genetic profile and novel circulating biomarkers. AtheroRemo-IVUS is a prospective,     observational, cohort study of patients who underwent coronary catheterization for acute     coronary syndrome or stable angina pectoris. Prior to the catheterization procedure, blood     samples were drawn for biomarker measurements and genetic analyses. Subsequent to the     catheterization procedure, intravascular ultrasound is performed in a non-culprit coronary     artery. In patients who are also participating in the AtheroRemo-NIRS substudy, near-infrared     spectroscopy is additionally performed in the same non-culprit vessel. Primary endpoint is     the presence of vulnerable plaque as determined by intravascular ultrasound. Secondary     endpoint is long-term incidence of major adverse cardiac events. Results from AtheroRemo-IVUS     are expected to improve our knowledge on the role of genetic profile and inflammation in the     development of atherosclerosis and vulnerable plaques. Furthermore, novel biomarkers and     intracoronary imaging techniques will be validated in this study.   "
114328|NCT01789398|"     This is a multicentric international phase III, double blind randomized study assessing     efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on     to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS)     during 8 weeks   "
114329|NCT01789385|"     Deep brain stimulation for the treatment of Parkinson's disease has unique surgical stages     and anesthesia needs. In the first stage the electrodes are inserted in the targeted brain     areas and in the second stage the pulse generator is implanted. The technique for     establishing sedation and analgesia for functional neurosurgery may differ among     institutions. In this study it was aimed to investigate our anesthesia methods,     intra-operative adverse events in the first stage of deep brain stimulation and the post     operative pain therapy of the patients.   "
114330|NCT01789372|"     The purpose of this study is to determinate if mediyoga has effects in quality of life, heart     rate variability, blood pressure , heart rate in patients with paroxysmal atrial fibrillation     (PAF).   "
114331|NCT01789359|"     Essentially all of the published data on anthocyanin absorption in humans are from short term     studies - a few days or less, most typically 24 h. However human studies demonstrating     clinical effects are typically conducted for several weeks or even months. To examine how     anthocyanin absorption and metabolism may be affected this study will examine urinary     excretion of anthocyanins over one month, followed by a one week washout, and then one more     dose of blueberry juice.   "
114332|NCT01789346|"     The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium     titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the     treatment of fresh surgical scars.   "
114333|NCT01789333|"     The purpose of the study is to see if brighter lights will allow for shortening of the     treatment time required to stabilize the eyes of patients with keratoconus or a bulging     cornea. The investigators will be comparing the therapeutic effects of two different higher     brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as     bright as the other and the exposure time of these brighter lights to deliver equivalent     energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes.     Riboflavin is vitamin B2 and the investigators are trying to determine if an identical     clinical effect can be achieved the brighter treatment lights are used for shorter times. The     investigators will also monitor the clinical effect and the status of the cornea to see if     additional risks are associated with the brighter light.   "
114334|NCT01789320|"     This study is designed to determine the safety and tolerability of a single microinjection of     triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have     non-infectious uveitis.   "
114335|NCT01789307|"     Lactose, one of the key nutrients in human milk may be critically important to infants for     more reasons than being a source of energy. We are interested in understanding how lactose     when compared to other sugars influences how nutrients, specifically macronutrients are     handled after digestion and absorption. To date, there have been no studies looking at how     fat and protein varies when lactose compared to other sugars is ingested. There may be     metabolic advantages to considering lactose for nutrition support of premature infants rather     than glucose or dextrose as is often used in intravenous feeds, or the corn syrup solids in     lactose-free formulas. We hope the information from this study will provide new information     on the unique aspects of lactose.      Hypothesis: The hypothesis is that providing carbohydrate as lactose:        1. minimizes the amount of carbohydrate that is converted into fat        2. enables a relatively constant metabolic state throughout feeding interval that avoids          swings of high to low insulin, glucose, and fats.   "
114336|NCT01789294|"     Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the     clinical outcome of patients Methods.We recruited children who undergone diagnostic     colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility     criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment     assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs     mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and     patch test for common foods, and symptoms scoring at baseline and follow up have been     performed by blinded clinicians. Chi-square test for trend was used to compare the frequency     of symptoms score improvement (>1 point) among groups. The association of baseline features     of patients with the clinical response was estimated by frequency analysis.   "
114337|NCT01789281|"     Study to allow access to everolimus for patients who are on everolimus treatment in a     Novartis-sponsored study and are benefiting from the treatment as judged by the investigator   "
114338|NCT01789268|"     This clinical study will investigate the relationships between sequential respiratory viral     infections, patterns of intestinal and respiratory bacterial colonization, and adaptive     cellular immune phenotypes which are associated with increased susceptibility to respiratory     infections and long term respiratory morbidity in preterm and full term infants. This is a     prospective, cohort study, enrolling at a single center via two sites (URMC and     URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be     accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150     pre-term and 130 full-term.   "
114341|NCT01789229|"     Establishment of a tumor bank, consisting of tissue samples of tumor patients (benign and     malign tumors) and healthy people as controls. The tissue samples will be collected     systematically together with the corresponding clinical data. The biological samples, the     clinical date together with prospective experimental date constitute the entity of the tissue     tumor bank.      This tumor bank for tissue samples, together with our tumorbank for blood samples     (NCT01763125) combined constitute the entity Tumorbank.   "
114342|NCT01789216|"     The purpose of this study is to definitively resolve questions regarding the use of     multimodal pharmacologic pain management for orthopedic trauma patients in the context of a     multicenter, randomized clinical trial.      Also, as a significant proportion of this population develops chronic post traumatic     osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and incidence     of chronic pain and PTOA in this population.   "
114343|NCT01789203|"     BK infection is an important cause of graft dysfunction and graft loss after renal     transplantation. It has been widely accepted that emergence of BK virus correlates with the     more potent immunosuppressive agents used to lower acute rejection rates. In contrast to     other opportunistic infections after transplantation, for which routine prophylactic agents     are administered, there is no effective agent for the prevention of BK infection. Some data,     however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against     BK virus. This has led us to investigate whether routine, short-term ciprofloxacin     administration post-transplant can lower the incidence of BK infection.   "
114344|NCT01789190|"     In diabetes, the honeymoon period is characterized by the presence of a functional reserve of     β-cells that favours an adequate metabolic control and low insulin needs in order to control     glycaemia. Therefore, the extension of this period could have evident benefits in diabetes     management. The investigators aimed to study the influence of regular physical activity on     the prolongation of the honeymoon period   "
114345|NCT01789177|"     We hypothesize that the addition of modified incentive spirometry to standard postoperative     chest physiotherapy will be associated with faster return to baseline/predicted pulmonary     function and fewer postoperative pulmonary complications in patients following laparotomy.   "
114346|NCT01789164|"     The goal of this project is to determine if it is possible to assess Cerebrovascular     Reactivity (CVR) to hypercapnia with functional Near Infrared Spectroscopy (fNIRS). Such a     method would be particularly helpful in traumatic brain injury (TBI), where objective     measures are needed, and would greatly expand the capacity to make such assessments in     standard clinical practice.   "
114347|NCT01789151|"     Preliminary data following a pilot study from our institution confirms the ability of     99mTc-glucosamine (99mTc-ECDG) to differentiate between active, subclinical and quiescent     disease in patients with rheumatoid arthritis, scleroderma lung, and vasculitis. We propose     to extend these findings and further evaluate this imaging modality for its clinical utility,     limitations, and application.      An unacceptably high level of morbidity exists amongst patients suffering from rheumatic     disease. This is often the result of mild disease being missed or misdiagnosed, and therapy     inordinately delayed or inappropriate. The currently used therapeutic agents themselves have     associated side-effects adding to unfavourable clinical outcomes. There is therefore a need     for a superior, less expensive and more easily accessible imaging modality to assess the     degree of inflammation to guide the clinician. Glucosamine is absorbed and metabolised in a     manner not too dissimilar to that of glucose, and it can be readily labelled to form     99mTc-ECDG. Scans can be acquired within 3 hours of intravenous administration of this agent,     accurately depicting sites of active inflammation/disease.      HYPOTHESIS Glucose is a vital cellular substrate that accumulates at inflamed tissues because     of the greater metabolic needs of the cells during active disease. Glucosamine, being an     analogue of glucose, is metabolised more quickly in inflamed than non-inflamed tissue and     thus 99mTc-ECDG scintigraphy like 18-Fluorodeoxyglucose (18FDG-PET) scintigraphy allows for     detection of active inflammation. Unlike current bone scans this agent has the sensitivity to     detect subclinical inflammatory disease that would in turn provide essential information to     ensure accurate diagnosis and treatment.   "
114348|NCT01789138|"     The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the     impact of a situated treatment adherence intervention program among persons living with     HIV/AIDS on antiretroviral therapy in Estonia.   "
114349|NCT01789125|"     The primary aim of this research study is to enhance smoking cessation outcome among smokers     with anxiety disorders. We are comparing two group treatment approaches: (1) An     educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An     integrated smoking cessation and anxiety treatment program (START). Both treatments also     utilize nicotine replacement therapy.   "
114350|NCT01789112|"     Electric stimulation by cardial contractility modulation (CCM)to improve contractility and     physical capacity   "
114351|NCT01789099|"     In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic     peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as     immunological response will be assessed. The purpose of this study is to select a biological     dose of peptides for further clinical trials. Study recruitment completed at 6 patients in     every dose level.      The main study treatment phase of this study is completed and will be reported separately.      Follow-up is ongoing   "
114352|NCT01789086|"     This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability     and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese     adolescent subjects aged 12 to 17 years.   "
114353|NCT01789073|"     The purpose of this study is to investigate the effect of preoperative immunonutrition on     complications and length of hospital stay in patients with pancreatic cancer undergoing     elective surgery.   "
114354|NCT01789060|"     PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway.     However, clinical information about the significance of p-AKT expression in malignant     lymphoma is not fully understood yet. In this study, we investigated the overexpression of     p-AKT and its prognostic implication in malignant lymphoma.   "
114355|NCT01789047|"     The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed     comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in     the treatment of PD patients who continue to have dyskinesia on amantadine.   "
114356|NCT01789034|"     A prospective observational study on predictors available and on variables of difficult     intubation adopting Gliscope video laryngoscope routinely.      Primary hypothesis of the current study is that the rate of difficult intubation with     Glidescope is low and multiple predictors interact favorably in anticipating difficulties.   "
114357|NCT01789021|"     In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring     system and blood glucose monitoring systems from other companies across the overall tested     glucose range will be performed.   "
114358|NCT01789008|"     Alcoholic liver disease is the most frequent complication of excessive alcohol consumption.     Early diagnosis of alcoholic liver disease is essential to avoid its complications that could     be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver biopsy.     The transient elastography is a useful tool for early diagnosis of liver fibrosis. This tool     is validated in the diagnosis of liver fibrosis due to C chronic hepatitis. Because it is     non-invasive, fast, given immediate results; transient elastography could be repeated in     alcoholic patients for liver fibrosis follow-up. In the present study, the investigators     propose to realize liver biopsy and transient elastography in 300 alcoholic patients in     weaning to evaluate the transient elastography accuracy in the exclusion of sever liver     fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be the liver     biopsy.   "
114359|NCT01788995|"     This non-interventional study will evaluate the routine use and the safety and efficacy of     Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer     (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly     diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination     with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.   "
114360|NCT01788982|"     For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis     pathway has several potential targets. The Receptors for Vascular endothelial growth factor     (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation     as well as the maintenance of tumor vasculature.      In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the     fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often     overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in     tumor angiogenesis express these receptors as well.      Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive     results. However there is no treatment that is generally considered as standard of care for     patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have     progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a     clinically meaningful benefit yet.      Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF.     Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle     cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase     activity rationale exists to investigate the effect in MTC and DTC.      Because it targets these three major angiogenesis signaling pathways it might prevent further     tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in     patients who have progressed on agents that target only one pathway.   "
114361|NCT01788969|"     The manifestation of weakness and involuntary reflexes following motor incomplete spinal cord     injury (SCI) may be partly a result of damage to descending pathways to the spinal cord that     release serotonin. In models of SCI, for example, application of agents that simulate     serotonin has been shown to modulate voluntary motor behaviors, including augmentation of     walking recovery. In humans following neurological injury, the effects of 5HT agents are     unclear. Few previous reports indicate improved motor function following administration of     agents which enhance the available serotonin in the brain, although some data suggests that     decreased serotonin may be beneficial. In this application, the investigators propose to     study the effects of clinically used agents that increase or decrease intrinsic serotonin     activity in the brain on strength and walking ability following human motor incomplete SCI.     Using detailed electrophysiological recordings, and biomechanical and behavioral measures,     the investigators will determine the effects of acute or chronic doses of these drugs on     voluntary and involuntary motor behaviors during static and dynamic conditions. The novelty     of this proposed research is the expectation that agents that enhance serotonin activity may     increase abnormal reflexes in SCI, but simultaneously facilitate motor and walking recovery.     Despite potential improvements in voluntary function, the use of pharmacological agents that     may enhance spastic motor behaviors following SCI is in marked contrast to the way in which     drugs are typically used in the clinical setting.   "
114362|NCT01788956|"     The intent of this study is to validate the venous blood oxygenation measurements of the     Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an     inserted central vein catheter, which is currently the standard of care for measuring SvO2   "
114363|NCT01788943|"     The investigators propose to use positron emission tomography (PET) imaging to determine     whether nicotinic receptor availability at pretreatment predicts smoking cessation success.     The investigators will recruit 30 smokers from those enrolled in the Pharmacogenetics of     Nicotine Addiction Treatment clinical trial. The investigators will measure nicotinic     receptor availability using the PET radioligand 2-[18F]FA, after overnight abstinence and     prior to initiation of treatment.   "
114393|NCT01788553|"     The aim of the study is to assess the remission rates in patients treated for generalized     anxiety disorder in primary and specialized care. Factors that may influence remission such     as disease history and severity of the anxiety disorder, the type of treatment, the presence     of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be     evaluated. The study will also assess patient functioning and compare functioning in patients     who do and do not achieve remission.   "
114364|NCT01788930|"     Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet     activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence     up to 60%.      The main objective of our study is to analyze the influence of sleep apnea on the response to     antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.      Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep     apnea will be recruited after providing informed consent. Response to aspirin will be     assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal     polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other     endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at     baseline to determine their influence on the response to aspirin.      Then, Patients with severe SAS (Apnea-Hypopnea Index> 30 events/h) and response with Aspirin     (ARU > 454) will be randomized to 3 months of active or sham continuous positive airway     pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin     will be compared between the sham and effective CPAP groups.   "
114366|NCT01788904|"     In the FARAMIS study, we aim to investigate the longitudinal course of intestinal plasma     fatty acid binding protein (i-FABP) in patients with acute mesenteric ischemia (AMI)     undergoing primary percutaneous angiographic intervention.      The investigators postulate that patients with fully re-established intestinal blood flow and     vital intestines will display a significant drop of plasmatic i-FABP within 24 hours, while     patients requiring subsequent intestinal resection due to irreversible bowel necrosis will     not.      If true, patients requiring laparotomy and bowel resection could be identified and patients     in whom angiographic intervention led to successful cure of disease would not be exposed to     potentially perilous surgery.   "
114367|NCT01788891|"     This study will help identify which ARV candidates should be prioritized for pediatric use in     resource-limited settings   "
114368|NCT01788878|"     The aim of this study is to explore the main factors associated with the return to work of     patients presenting an upper aero-digestive tract cancer.   "
114369|NCT01788865|"     The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable     dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.   "
114370|NCT01788852|"     This study will assess the prevalence of HPV infection in perinatally HIV-infected     adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.   "
114371|NCT01788839|"     The purpose of this study is to see how cancer treatment affects sexual and reproductive     function. The patient will also be asked to participate in blood draws to see if and how     cancer treatment affects the ovaries and the ability to have children (fertility). These     blood draws are optional and the patient can still participate in the questionnaire portion     of the study even if they choose not to have their blood drawn.   "
114372|NCT01788826|"     The incidence of ventral hernias has remained inappropriately high. Any innovation in order     to reduce this incidence would be simply cost-effective. Although there is still some concern     about the use of mesh in clean-contaminated or contaminated surgery, based in our     experimental studies, we plan to use a mesh in the primary closure of abdominal incision to     prevent incisional hernias.      The investigators propose a clinical trial to assess a model to prevent the incisional hernia     after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization is     scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide     polypropylene mesh is fixed covering the midline closure; in the control group a conventional     closure with a running suture of long-term absorbable material with a suture/wound length     ratio 4:1. The sample size was calculated with an estimated incidence of ventral hernia of     25% in the control group and 10% in the intervention group, 0,05 alfa and a 0,15 beta error.     The main goal is the appearance of a ventral hernia after 24 months of follow-up. Other     outcomes are wound complications and morbidity. Exclusion criteria are adult patients with a     previous ventral hernia, estimated survival of less than 6 months or hemodynamic instability     during surgery.      The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24     months and abdominal CT controls at 6,12, and 24 months. The study will be statistically     evaluated with SPSS 18.0.   "
114373|NCT01788813|"     The purpose of this study is to examine the safety and effects on the immune system of     treatment with GSK2245035 in subjects who suffer from nasal symptoms caused by an allergy to     pollen or perennial allergen, with or without mild asthma. In addition, the effect of     treatment with GSK2245035 on the body's allergic response in test situations will be     explored. Approximately 28 subjects will receive GSK2245035 (up to 14 subjects each receiving     80 nanograms [ng] GSK2245035 and up to 14 subjects each receiving 20 ng GSK2245035) and 14     subjects will receive the dummy drug (placebo) during the study. Assignment of a subject to     GSK2245035 or placebo will be done by chance, like flipping a coin. Neither the subjects nor     the clinic staff will know whether a subject is being dosed with GSK2245035 or placebo during     the course of the study. The study will include (a) Screening phase where the eligibility of     subjects for enrolment will be assessed (b) Treatment phase during which subjects will     receive either 8 nasal sprays of GSK2245035 80 ng or a matching placebo once weekly for 8     weeks (each dose will be split between the two nostrils). Subjects participating in this     study in 2014 will receive a reduced dose of 20 ng i.n. of GSK2245035 once weekly for eight     administrations (c) Follow-up period where any GSK2245035 induced changes to the immune     system and the effect of treatment on the body's allergic response in test situations will be     monitored. The maximum planned study duration for all subjects, including the screening,     treatment and follow-up periods, is approximately 180 days.   "
114374|NCT01788800|"     Physical activity (treadmill) supports the effect of cognitive behavioural therapy in     patients with panic disorder with/without agoraphobia   "
114375|NCT01788787|"     The goal of this behavioral research study is to learn about the outcomes of smoking     cessation treatment. Researchers want to learn how many smokers stopped smoking after taking     part in smoking cessation treatment with the Texas Quitline.   "
114376|NCT01788774|"     This clinical trial is designed to evaluate different dosages of risperidone ISM, a new     long-acting injectable form.   "
114394|NCT01788540|"     Intralipid infusion can improve the outcome in NK cells positive females with history of     recurrent miscarriages undergoing IVF/ICSI cycles.   "
114377|NCT01788761|"     This is a research study that will look at the effects of giving two nutritional supplements     on extremely low birth infants (infants weighing less than 1000 grams or weighing less than     approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied     are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that each     contain a different probiotic. In this study the investigators will mainly be looking at the     effect that these supplements may have on how well babies tolerate their feedings and how     long they require supplemental intravenous fluids for nutritional support. The investigators     will also, however, look at many other factors such as rate of growth, rates of infection,     survival rate and the length of time the infant needs to be in the hospital. The     investigators will also look at its effect on conditions/complications of prematurity such as     bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung associated     with prematurity), necrotizing enterocolitis and intestinal perforations (serious diseases of     the infant's intestines), retinopathy of prematurity (eye disease associated with     prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus arteriosus     (a blood vessel connecting two main blood vessels coming out of the heart that does not close     spontaneously (by itself).   "
114378|NCT01788748|"     This is an interventional open prospective randomized study, done in two sites.      The main purpose of this study is to evaluate the efficacy of the combination of bipolar     radiofrequency potentiated by an infrared light followed by fractional bipolar radiofrequency     for the treatment of striae on the abdomen.      In order to have a more complete and accurate study, each technology will also be evaluated     separately. This will allow the comparison of the effect of each treatment, in monotherapy or     combined.   "
114379|NCT01788735|"     Unexplained infertility is defined as the lack of thec ability to become pregnant during the     first year, although the periods of the woman, the semen from the man and the laparoscopic     findings are normal. In Denmark do roughly every fifth to seven couple in the fertile age     have problems becoming pregnant for a various kind of reasons, of these are 10-15 %     unexplained infertile.      Many factors are pointed out as imported. In particularly lifestyle factors such as the diet,     smocking, obesity, lack of physic activity and alcohol. The causal connection is yet to be     found, but it is assumed that there is a link between infertility and endocrine, neurological     and immunological factors.      Asthma and allergy are some of the most common diseases among young people in western world     .The development of these diseases are caused by both hereditary factors, and factors that     also seem to be important in infertility.      It is clinically observed that many unexplained infertile patients simultaneously suffer from     asthma and allergy. Furthermore this group of patients seems harder to treat in terms of     becoming pregnant during fertility treatment then healthy not asthmatic and non allergic     persons.      There is limited available data about this subject and the data that is already collected     does not show a clear tendency.      Hypothesis: Atopic asthma is characterized by a systemic inflammation and can therefore be     the reason for infertility among this group of patients.      The aim:      The aim of this study is to examine whether female asthmatics and allergic are less fertile     then healthy females- whether there is there a link between asthma and infertility.     Furthermore if an optimal asthma treatment during fertility treatment reduces time to     pregnancy.   "
114380|NCT01788722|"     The objective of the study is to investigate and collect post marketing data on the safety     and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a     subset of patients - at optional long-term follow-up visit after about 1 year of treatment     under daily practice treatment conditions in Korean women and to obtain data on drug     utilization on treatment for endometriosis.   "
114381|NCT01788709|"     The colonoscopy accuracy and safety depend on the quality of colon cleansing. An inadequately     prepped bowel will increase the risk of missing a lesion, prolong procedure, increase patient     discomfort, and eventually increase complication rate. Therefore an excellent colon cleansing     is of extreme importance to the endoscopist and the patient.      Split Fortrans® prep with sugar-free mentholyptus drops (Halls®) has a better palatability     and tolerability than the reduced volume ascorbic acid-supplemented PEG-electrolyte     (MoviPrep®) in bowel cleansing for colonoscopy.   "
114382|NCT01788696|"     The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool     in the management of early Parkinson's disease (PD).   "
114383|NCT01788683|"     The primary objective of this study is to compare the improvement in subject-reported     clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted     supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy     and durability up to 24 months.      Secondary objectives include evaluation of US evidence of tendon repair; incidence of     post-operative complications, adverse events, re-injections, and surgical intervention;     change in pain score and use of pain medications.   "
114384|NCT01788670|"     Health benefits for humans derived from low dose intake of ethanol could partially be     explained by its interaction with dopamine (DA) oxidative metabolism. Ethanol is expected to     induce an increase in the formation of a DA minor metabolite: DOPET (hydroxytyrosol).     Hydroxytyrosol is one of the most potent antioxidants present in Mediterranean Diet. The     study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.   "
114395|NCT01788527|"     The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose     Monitoring) can improve glycemic control in women with T1D who are pregnant or planning     pregnancy.   "
114396|NCT01788514|"     The investigators have developed an influenza-vaccination-education-study-program that will     involve the use of an animated influenza vaccine-based computer program (videogame) that is     designed from the investigator's own initiative. The investigators propose implementing an     influenza vaccination educational program in the pediatric satellite office that serves a     population that has historical low rates of influenza vaccination.   "
114397|NCT01788501|"     This study aims to compare efficacy and safety of tacrolimus/methotrexate with     cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic     hematopoietic stem cell transplantation patients.   "
114398|NCT01788488|"     The goal of the study is to determine the impact of procalcitonin (PCT)-guided therapy on     duration of antibiotic therapy in critical care unit (CCU) patients with suspected pneumonia     at Mayo Clinic Health System Eau Claire.   "
114385|NCT01788657|"     Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in     several studies, however the investigators know very little about how the written treatment     material should be designed to be effective and at the same time acceptable to the patients.     The investigators are not aware of any research that has investigated if slow readers, or     persons with difficulty concentrating, can use the standard material or if they would benefit     more from using an adapted version.      In this study the investigators will assess reading speed and the ability to concentrate in     all patients and then randomise them to an internet-based treatment for depression using     either a standard material or a condensed one. The condensed material consists of 30000 words     and will be available as text files and on audio files. The standard material consists of     60000 words and is only available as text files. Both groups will have the possibility of     e-mail contact with a personal therapist during the treatment.      Patients will be recruited within Örebro County by referrals and self-referrals. The goal is     to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks     and all patients will be assessed for depression at an interview with a psychologist. There     will also be interviews after treatment and one year after treatment. The most important     outcome will be depressive symptoms.   "
114386|NCT01788644|"     The purpose of this study is to examine risk factors associated with infant growth and the     development of obesity in the first year of life. The investigators plan to establish a     racially and ethnically diverse southern cohort of 800 mother/infant dyads, followed     regularly from birth to 12 months of age. The cohort will be residents of Durham, North     Carolina (NC) and the immediate surrounding area. The proposed longitudinal study will     examine factors contributing to the development of obesity, including dietary behaviors,     physical activity and inactivity, stress, and sleep duration and quality. Frequent in-home     assessments throughout infancy and contact with other care providers will help pinpoint     exactly when children begin to gain weight excessively and will identify risk factors related     to energy intake, energy expenditure, stress, and sleep associated with obesity.   "
114425|NCT01788137|"     This is a prospective , open, multicenter, randomized phase III study. The investigators     planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT     regimen groups after signature the informed consents. The patients will receive safety     assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up     will be received after finishing the treatment.   "
114387|NCT01788631|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug called Regadenoson (or Lexiscan) to learn whether the drug works in     treating a specific disease, in this case Sickle Cell Disease (SCD). Investigational means     that the drug is being studied. It also means that the FDA has not yet approved the drug for     your type of disease.      SCD is an inherited blood disorder that causes the red blood cells to change their shape from     a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different     type of protein that carries oxygen in their blood (hemoglobin) than people without SCD. This     different type of hemoglobin makes the red blood cells change into crescent shape under     certain conditions. Sickle-shaped cells are a problem because they often get stuck in the     blood vessels blocking the flow of blood, and cause inflammation and injury to important     areas in the body.      Regadenoson (trade name Lexiscan) is a drug that may prevent this inflammation and injury     caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast     infusion during a heart stress test in people who are unable to exercise enough to put stress     on their heart by making the heart beat faster. Regadenoson has been studied as a long     infusion at this dose in adults, and no safety issues have been identified     (ClinicalTrials.gov Identifier: NCT01085201). This is the first study to look at patient     benefit with the long infusion of the drug. This drug has been used in laboratory experiments     and information from those other research studies suggests that this drug may help to protect     the body from damage caused by sickle-shaped cells in this research study.      In this research study, the investigators are specifically looking to see if Regadenoson is     an effective treatment for pain crises and acute chest syndrome in SCD.   "
114388|NCT01788618|"     Our study aims to measure the impact of cognitive rehabilitation workshops on the development     of cognitive functions and quality of life of patients expressing a cognitive complaint   "
114389|NCT01788605|"     1. The purpose of this study is to determine the efficacy of ramosetron for the prevention          of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic          treatment during hematopoietic stem cell transplantation        2. The study hypothesis is that ramosetron is effective for the prevention of emesis and          control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy          in the setting of hematopoietic stem cell transplantation   "
114390|NCT01788592|"     The objective of this study is to evaluate effectiveness and safety of drug-eluting stent     implantation in the real world daily practice.   "
114391|NCT01788579|"     This study aims to conduct a randomized controlled trial that will test the feasibility and     preliminary effect of a multimedia version of a computerized multimedia intimate partner     violence (IPV) prevention service tool designed to increase identification of IPV     victimization and to improve linkages to IPV-related services among female offenders under     court supervision or probation, compared to a non-media version of the same IPV screening,     brief intervention and referral service delivered by a case manager. The study addresses the     following: Primary study aims        1. To design and beta-test a Computerized Multimedia IPV Screening, Brief Intervention and          Referral Service tool for female offenders under court supervision or probation.        2. To obtain preliminary estimates of the effects of the Computerized Multimedia versus the          Case Manager IPV service conditions on identification of different types of IPV during          the service session and on access to and utilization of IPV services over the          three-month follow-up period.        3. To examine and enhance the feasibility (recruitment, enrollment, fidelity of service          delivery, client satisfaction, safety, and retention) for a future larger scale R01          study.           Secondary study aim        4. To obtain estimates of the effects of the Computerized Multimedia versus the Case          Manager IPV service conditions on recidivism, adherence to drug treatment (e.g.,          attendance, completion) and abstinence of substance use over the follow-up period,          controlling for baseline outcomes.   "
114392|NCT01788566|"     The purpose of this study is to see how participants with late stage lung cancer do on     gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the     drugs are in combination and to see how long the medicine stays in the body. The study will     last approximately 2 years.   "
114399|NCT01788475|"     Currently medications injected intravitreally in previously vitrectomized eyes have a very     short half-life due to enhanced clearance of the drug. The use of the Ozurdex implant may     allow sustained levels of steroid delivery to patients with diabetic macular edema that have     undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal     thickness measurements and improved visual acuity.   "
114413|NCT01788293|"     Oximetry monitoring is common practice in patients undergoing anesthesia. PVI continuous     evaluation may be a possibility of agility and ease of obtaining accurate information about     the state of cardiovascular responsiveness to volume expansion.      This prospective and randomized study will try to demonstrate that the assessment of PVI is a     simple and cost-saving method as compared to cardiac output or oxygen delivery monitoring     technologies. Such a simple approach has therefore the potential for widespread application     as it is not routinely feasible for anesthetists to use cardiac output or oxygen delivery     monitoring technologies in many institutions, as well as in many countries.   "
114400|NCT01788462|"     Sleep-disordered breathing is characterized primarily by partial or total upper airway     obstruction during sleep. The most common form of sleep-disordered breathing is obstructive     sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep     state. The major risk factors associated with the development of sleep apnea are obesity and     male sex. The investigators have also found a high prevalence of OSA in HIV infected men and     women, particularly among those with central lipohypertrophy, which is a common finding in     HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is     that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters     both mechanical properties and compensatory neuromuscular responses leading to upper airway     obstruction. Based on our most recent findings in the non-HIV population, the investigators     demonstrate that obesity is associated with elevations in the upper airway load (passive     Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the     investigators have found that female sex, peripheral adiposity, and younger age are     associated with increased compensatory neuromuscular responses, while male sex, central     adiposity, and older age are associated with blunted compensatory responses. The loss of the     compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected     patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing     hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The     investigators hypothesize that tesamorelin therapy will reverse both the mechanical and     neurocompensatory alterations associated with increased central obesity. In this project the     investigators will determine whether tesamorelin affects sleep apnea severity and     compensatory neuromuscular responses of the upper airway on sleep and breathing in men and     women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic     basis for the development of obstructive sleep apnea in this population. The studies also     provide insights into the neurohumoral regulation of upper airway function, and potentially     new approaches to the treatment for sleep-disordered breathing.   "
114401|NCT01788449|"     Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and     infection of bacteria.   "
114402|NCT01788436|"     The purpose of this study is to measure and contrast implicit and explicit learning     performance in patients with schizophrenia relative to young and elderly healthy volunteers.   "
114403|NCT01788423|"     The purpose of this study is to compare the outcomes for two different hearing-aid delivery     models. In one model, the audiologist selects and fits the hearing aid and, in the other     model, the consumer does this directly.   "
114404|NCT01788410|"     The objective of this study is to provide pain relief to patients with facet joint disease or     head and neck pain related to compression of a nerve root. The goal is to provide palliative     care with superior efficacy and longer relief compared to current methods.   "
114405|NCT01788397|"     The main hypothesis:      The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The     groups waiting for rehabilitation is compared with the group receiving rehabilitation   "
114406|NCT01788384|"     Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant     Pharmaceuticals, North America, is a safe and effective topical therapy used for the     treatment of acne vulgaris.   "
114407|NCT01788371|"     To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of     the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with     high level of HBV DNA.   "
114408|NCT01788358|"     This study examines the long term safety and efficacy of the Fixed Dose combination     BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in     patients with moderate to severe hypertension.      Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks,     including 8 weeks with stepwise dose increase up to the high target dose. The first 200     subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in     total).      Subjects who do not tolerate an increased dose will be treated at their highest tolerable     dose.   "
114409|NCT01788345|"     The purpose of this study is to determine whether the new Boussignac-system of non-invasive     ventilation is as good as the conventional non-invasive System in patients presenting with     acute hypercapnic respiratory failure.   "
114410|NCT01788332|"     In 2010, more than 35,000 people died in the United Kingdom from lung cancer, the majority     from non-small cell cancer (NSCLC). Chemotherapy is one of the main treatments for patients     with NSCLC but those treated will still only live for an average of 9 or 10 months after     diagnosis.      The purpose of this clinical trial is to find out whether or not giving a drug called     Olaparib following chemotherapy will benefit patients with NSCLC who have responded to     initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is     a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The     rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC     tumours that respond to chemotherapy are less able to repair this damage. This can be     exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP)     which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death     by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of     mutation in two or more genes leads to cell death.      Up to 300 patients who are to receive standard chemotherapy treatment will be initially     registered into the trial. Of these patients, 114 patients who have responded to chemotherapy     will be randomly allocated to receive either Olaparib or an inactive dummy pill or placebo by     mouth. The trial will assess whether Olaparib delays disease progression following standard     chemotherapy treatment in patients. It will also show whether the side effects of adding     Olaparib following standard treatment are acceptable.   "
114411|NCT01788319|"     This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as     or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment     strategy for glaucoma patients. It is done with a laser device that can also be used for many     other ophthalmic applications, thus reducing the economic burden of treatment.   "
114422|NCT01788176|"     To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of zoledronic     acid in managing pain in Complex Regional Pain Syndrome patients.   "
114423|NCT01788163|"     Interventional diagnostic, international, multicenter and non-comparative study of EGFR     mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with     adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and     Russia and will assess the current status of EGFR mutation testing, and the concordance of     EGFR mutation status derived from tumour samples and blood based circulating free DNA.   "
114412|NCT01788306|"     This prospective, randomized emergency department trial will study the effectiveness of an     intervention that combines opioid overdose prevention, education and intervention that     includes take home naloxone with brief behavioral change counseling. The study will recruit     both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose     (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk     behaviors.      Primary Aims      The primary aims are to test whether those who receive the intervention compared to standard     care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use,     inappropriate medication use, and other overdose risk behaviors.      Secondary Aims      The secondary aims are to test whether those who receive the intervention compared to     standard care have: 3) More appropriate health care utilization (e.g. fewer emergency     department visits and admissions to inpatient care); 4) Lower total health care costs; 5)     Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users     at risk for overdose and whether the intervention impacts these behaviors.   "
114521|NCT01786837|"     The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS)     on gastrointestinal motility in patients suffering from chronic constipation due to     non-neurological issues.   "
114414|NCT01788280|"     This exploratory study uses [18F] Fluciclatide and Positron emission tomography (PET) imaging     in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab. The primary     objective of this study is to determine the association of [18F] Fluciclatide uptake,     fludeoxyglucose (FDG) uptake, and tumor blood flow/perfusion determined with H215O and     Magnetic resonance imaging (MRI) and correlate these variables with time to progression (TTP)     in participants with GBM treated with Bevacizumab.   "
114415|NCT01788267|"     Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD)     potentially leading to pathological fractures at adult age. Recent data from our center and     others have suggested that low BMD could be observed very early in life. However,     quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be     confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).      High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology     with very high spatial resolution. Images obtained with this technic are considered as     virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces     exploration in a three-dimensional manner, and therefore provides informations on bone     microarchitecture as well as bone density.      The aim of this study is to evaluate bone microarchitecture of paediatric patients matched to     sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be     collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore     potential correlations HR-pQCT parameters.   "
114416|NCT01788254|"     Aim of this study is to comprehensively assess in healthy volunteers the metabolic processes     and factors that define drug response. Sources of variability are to be investigated and     factors that can alter the hepatic metabolism and the pharmacokinetics of drugs shall be     quantified.      Determination of variability is important when the pharmacokinetics of new drugs is being     investigated and when the concept of individualized medicine is to be further developed. It     is important to identify and differentiate between pharmaceutical, physiological (e.g. liver     blood flow, renal function), environmental (e.g. foods and lifestyle), and genetic sources of     inter-individual variability. For instance, inaccurate or false conclusions may be drawn from     a single pharmacokinetic study, if the investigated medicine is metabolized by an enzyme with     large inter-individual variability. Knowing the causes of variability and of the quantitative     contribution of various processes might help to improve the oral formulations of drugs, might     help selecting the right preclinical tests and selection criteria during clinical     development, provide the basis to understand the influence of disease and to optimize     established drug treatments in order to make future drug treatment safer and more efficient.      This study is designed as an add-on to the study TWINS: Open Label Repeated Dose Study for     the Evaluation of Heritability of and Genetic Influences on Drug Pharmacokinetics (Eudra-CT:     2008-006223-31). Twins are not a random sample of the population, and they differ in their     developmental environment. In this sense they are not representative for the population Thus,     the results of TWINS cannot be automatically generalized but instead require validation in a     representative population sample. While both studies assess pharmacologic factors important     for drug response, TWINS contributes in particular data on the heritability of these     processes.   "
114417|NCT01788241|"     Psychosocial factors have been found to be associated with an increased risk for coronary     artery disease incidence, progression and worse clinical outcomes.      Patients with non-significant coronary artery disease (confirmed vascular irregularities, but     <60% coronary occlusion) often present with complaints such as chest pain, which warrant     screening by coronary angiography (CAG) or computed tomography (CT scan). The prognosis of     this group of patients with mild stenosis remains to be investigated in more detail, and we     propose that psychosocial factors play a role in the clinical prognosis and patient reported     outcomes in this group.      A special focus lies within examining personality characteristics, of which Type D     personality is a primary predictor variable for prognosis. Type D personality is     characterised by high negative affect and high social inhibition. In addition to psychosocial     factors (personality, mood state, social support, SES), biomarkers(inflammation, clotting,     DNA) as well as standard clinical risk factors (metabolic syndrome, activity level, smoking,     medication use, disease severity) will be investigated.      The goal of the proposed study is to investigate a preexisting psycho-biochemical risk     profile for major adverse cardiovascular events (MACE) and patient perceived symptoms in a     group with angiographically or CT-scan confirmed, non-significant coronary artery disease.   "
114418|NCT01788228|"     The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals'     vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of     exposure to the virus.   "
114419|NCT01788215|"     The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline,     on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian     Syndrome (PCOS).   "
114420|NCT01788202|"     When it is safe to administer general anesthesia to the patient with cocaine positive urine     drug screen has never been clearly determined. The study doctors would like to determine the     effect of cocaine on blood pressure, heart rate and rhythm during surgery. After surgery, the     subjects will be observed in regards to mental status and any changes in heart rate and     rhythm.   "
114421|NCT01788189|"     Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed     or refractory CD20-positive aggressive lymphomas      Phase I:      Dose escalation of methotrexate and cytarabine (days 1, 8 and 15 of each 28-day cycle) in a 3     + 3 design with fixed doses of lenalidomide (days 1 - 21) and rituximab (day 1), maximum 6     cycles      Phase II:      Treatment of 20 patients at maximum tolerated doses of phase I   "
114424|NCT01788150|"     A prospective, randomized, active-control, multi-center clinical trial comparing the safety     and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to     that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.      The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary     Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting     Stent in patients with single, never previously treated coronary artery lesions   "
114747|NCT01783886|"     To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the     best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy     study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.   "
114426|NCT01788124|"     The purpose of this study is to evaluate the comfort of two type of speculums used during     routine gynecologic exam. Your treatment and medical care will not change because you are     participating in this study. Your doctor will continue to make all decisions regarding your     proper treatment and care.   "
114427|NCT01788111|"     The purpose of this project is to investigate the occurrence of neck and back pain in a     population of commercial helicopter pilots, and investigate factors related to the profession     that can cause these problems. The project has a biological approach assessing the supporting     and stabilizing muscles (multifidus) in pilots with chronic back and neck ailments. Pilots     with low back problems are invited to a controlled intervention trial to investigate whether     one can achieve improved spinal health with a rigid training régime. Primary trial outcome is     improved neck and back multifidus muscles pathology and function as assessed by the extent of     fat infiltration -as visualized on MRI - and the volume and ability of the lumbar multifidus     muscles to contract as shown with ultrasound. The perceived effect on spinal health with sick     leave frequency is also evaluated.   "
114428|NCT01788098|"     The study is aimed at revealing genetic background in rheumatoid arthritis (RA). For that     purpose samples of DNA will be collected from 500 RA patients and similar number of controls     from whole Slovakia. Variations in several genes associated with RA will be evaluated. The     second aim is to assess functional changes in immune cells from selected patients and their     evaluation together with genetic background. The project has observational character without     any intention to change the treatment of RA patients.   "
114429|NCT01788085|"     Study Hypothesis: This study is designed as an integral part of the development of new or     improved features or components of the Bravo® pH Monitoring System and may serve verification     and validation purposes.      The study population will include symptomatic patients with known or suspected     gastroesophageal reflux disease      Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery,     positioning and attachment. Confirmation of capsule attachment may be done endoscopically.      These procedures will serve to evaluate overall system performance in actual clinical setup,     for instance: ergonomics and performance of delivery device, capsule transmission etc.      Physician may be asked to provide feedback on the procedure and/or document their activities     during the procedure.   "
114430|NCT01788072|"     There is substantial evidence from animal model and healthy control data, that oxytocin is     involved in the modulation of social cognition. In addition, recent genetics and plasma level     studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum     Disorders (ASD). As a large number of children with ASD are transitioning into adulthood and     will likely require treatment, the lack of data to make meaningful treatment recommendations     to facilitate adult living is an urgent issue. This study will examine the effect of     intranasal oxytocin (IN-OXT) on social function in adults with ASD. It is hypothesized that     IN-OXT will be superior to placebo in improving social function by the end of study     treatment.   "
114431|NCT01788059|"     Because the rate of non union of long bone in lower extremities specially in tibia in this     two last decade due to malnutrition and smoking and other risk factors was increased, so many     patient in our country suffer from non union on the other hand it seems that the use of the     mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to     inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll     procedure to non union site in patient that are resistant to other treatment. Then the     investigators will follow the patient with monthly radiography and evaluate the callus volume     and clinical union and any side effect of this treatment.clinical union consider to relief     pain in non union site and be stable in examination.   "
114432|NCT01788046|"     This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared     with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.   "
114433|NCT01788033|"     To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production     in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and     pharmacokinetics (PK) of XOMA 052 will also be assessed.   "
114434|NCT01788020|"     In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and     responses of short duration compared to other indolent lymphomas. Thus innovative approaches     are needed which combine excellent activity and tolerability in patients with WM, who are     mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab,     cyclophosphamide) was shown to be highly effective in patients with WM without inducing major     hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed     substantial activity as a single agent in WM with only very few side effects when given in a     weekly schedule. Based on these observations it is the aim of this study to test whether the     efficacy of the well tolerated DRC regime can further improved by adding Bortezomib.   "
114435|NCT01788007|"     The objective of this study is to compare the relative efficacy and safety of the test     formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod)     3.75% Topical Cream in the treatment of actinic keratosis. Both the test and reference     formulations will also be compared to a placebo cream to test for superiority.   "
114436|NCT01787994|"     This is an open label, dual cohort study evaluating safety, tolerability and immunogenicity     of redirected CD4+ T cells in HIV subjects.   "
114488|NCT01787279|"     This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to     patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys     180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during     treatment and for 24 weeks of follow-up.   "
114437|NCT01787968|"     T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII,     including all non-TcI). TcI is predominant in Mexico and Central America, while TcII     (non-TcI) is predominant in most of South America, including Argentina. In recent studies     from Argentina, the risk of congenital transmission has been estimated to vary between 2.6     percent and 7.9 percent. By contrast, we know very little about the congenital transmission     of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and     there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary     hypothesis is that congenital transmission rates are different for TcI versus TcII. Our     secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age,     parity, transmission in previous pregnancies) and their exposure to vectors are different in     regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test     these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000     women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure     transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we     will identify infants who are congenitally infected by performing parasitological     examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will     also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal     blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected     newborns, and serological examinations on siblings. We will estimate the exposure to vectors     in the household. In addition, we will measure prenatal outcomes among infected and     uninfected infants with seropositive mothers, and the birth weight of their siblings. The     specific aims of this study are: 1) To determine the rate of congenital transmission of TcI     compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and     exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is     predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to     TcI and TcII seropositive women.   "
114438|NCT01787955|"     Pylorus preserving pancreaticoduodenectomy (PPPD) has been considered as only curative     treatment modality for periampullary tumor. High mortality rates after PPPD have been reduced     down to 1%. However, postoperative morbidities are still reported around 10 to 20 % even in     high volume centers.The delayed gastric emptying syndrome(DGE) is one of major complications     after PPPD. Many randomized control studies reported that pylorus preserving method was not     related to the occurence of DGE. Thus,we assumed that large amount of biliary and pancreatic     juice might affect DGE.      With the aim to prove that the use of Braun anastomosis after PPPD can prevent DGE, the     investigators started the recruitment of patients with a periampullary tumors to this     clinical trial from february 2013 with the study hypothesis that patients with Braun     anastomosis had less DGE than those who only got conventional PPPD.      The investigators have calculated the number of patients necessaries to have statistical     significant differences in 60 patients with a rate DGE expected to be higher than 30%.      The study include all the patients that usually arrive to our surgery department and who are     indicated to PPPD for the curative treatment of periampullary tumor.      The study is randomized, double blind where the investigators and the patients do not know if     the patients are in the Braun anastomosis group or not, and prospectively analyzed. All the     clinical and laboratory or radiographic finds relative to the occurrence of DGE are recorded.   "
114439|NCT01787942|"     Deficiency in tear film lipid layer thickness (LLT) has been implicated in the development of     dry eye symptoms, and is influenced to a significant degree by the anatomy and function of     the eyelids. Patients who are considering blepharoplasty, even if it is for cosmetic reasons,     may subtle differences in eyelid anatomy that pre-dispose them to having an abnormal tear     lipid layer. Moreover, the changes in anatomy and contour of the eyelids following     blepharoplasty introduce a whole new group of factors, such as an altered palpebral aperture     and altered canthal fixation that can further change the eyelid's ability to maintain a     healthy tear lipid layer, for better or for worse. Such changes in tear lipid layer can be     detected with the aid of a newly acquired tear interferometer (LipiView, Tearscience Inc.),     but has never been done in the context of blepharoplasty management. Due to the strong     association between LLT and risk of dry eyes, we hope to investigate if there are significant     differences in LLT and other objective dry eye parameters in two situations: 1) patients     considering blepharoplasty as compared to other patients not considering such procedures 2)     patients before and after undergoing blepharoplasty. The results of these investigations can     go towards establishing LLT as an important objective parameter to account for before and     after blepharoplasty.   "
114441|NCT01787916|"     To our knowledge, no trial has specifically studied the effect of liraglutide combined with a     basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric     model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of     abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard     euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this     population.      Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will     present improved glucose control with decreased HbA1c, decreased fasting and mean weekly     glucose concentrations and glycemic excursions as well as increased insulin sensitivity     compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin     treatment will also present improved endothelial function, lower body weight, central adipose     tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.   "
114442|NCT01787903|"     The purpose of this study is to determine what the effects are of real-time continuous     glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus     and impaired hypoglycemia awareness.   "
114443|NCT01787877|"     Stroke represents the third commonest cause of death after heart disease and all types of     cancer combined, and is the leading cause of long-term permanent disability among adults.     Recombinant tissue plasminogen activator (tPA) is currently the only safe medical treatment     for acute ischemic stroke but only a small fraction of patients are eligible for a     thrombolysis treatment. Current guidelines on thrombolysis post stroke with tPA exclude its     uses beyond 3 hours after stroke onset and when time of onset is unknown thus excluding many     patients from potentially beneficial treatment.      For an appropriate triage and management of patients, it is essential to improve imaging     techniques beyond a simple CT scan. Perfusion computed tomography (PCT), currently considered     as an investigational technique, permits a quantitative determination of the cerebral     perfusion within the brain. It helps distinguish salvageable ischemic penumbra from     irreversibly infarcted core in acute stroke patients. This technique has therefore the     potential to select patients who are most likely to benefit from thrombolysis with tPA, can     be used to predict the benefit after thrombolysis and determine the suitability for other     therapeutic interventions. In patients with a primary diagnosis of TIA, PCT would help to     identify possible persistent cerebral ischemia but also provide important information for     rapid instigation of prophylactic strategies.      The diagnosis and management of patients with ischemic stroke and TIA is challenging and is     primarily based on clinical assessment in conjunction with neuroimaging. Development of     specific molecular biomarkers as additional tools to support a clinical diagnosis, exclude     common stroke mimics such as migraine or epileptic seizures, identify patients at risk of     disease, and help guide patient treatment by predicting complications following t-PA     treatment would be of great value.   "
114489|NCT01787266|"     The purpose of this study is to:        1. describe degree of symptoms and disability during and after pregnancy        2. to examine if women with pelvic girdle pain are able to correctly mark their pain          location on a pain drawing        3. to examine the responsiveness of The Pelvic Girdle Questionnaire   "
114444|NCT01787864|"     We propose a tissue sample collection study for patients at UNC who have undergone or will     undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal     adenocarcinoma as part of routine medical care.      Purpose:      To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and     after ablative therapy.      To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative     therapy.      To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the     cardia.      To assess the ability of immunohistochemical (IHC) staining of cardia tissues to predict     incident dysplasia in the cardia. Several well-characterized biomarkers, including p16, p53,     Ki67, cyclin D1, and cyclin A, will be assessed.   "
114445|NCT01787851|"     Patients with dilated cardiomyopathy who present for indwelling right heart catheterization     will be enrolled and randomized to either control or triheptanoin oil for five days.     Hemodynamics will be assess serially.   "
114446|NCT01787838|"     The purpose of this quality improvement project is to improve the immunization rates of an     at-risk adult population seen in an ambulatory healthcare environment, through the use of     targeted health education messages regarding pneumococcal immunization. Patients seen in an     out-patient pre-surgical testing center will receive 1) a one-page written information sheet     that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this     message, provided by the clinical staff, during the patient's interview.      At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory     healthcare environment (a pre-surgical testing center) will receive a one page, gain-framed     message that emphasizes the benefits of pneumococcal vaccinations. This educational material     will be reviewed and reinforced by clinical staff during the assessment phase of the clinical     visit. Among this group, there will be increased vaccination rate compared with at-risk adult     patients who did not receive this communication (prospective vs retrospective data).   "
114447|NCT01787825|"     The purpose of this study is to compare the clinical findings involving the small bowel     obtained with the Capso Vision Video Capsule Device to those results obtained with the     PillCam SB2.   "
114448|NCT01787812|"     The California Joint Replacement Registry (CJRR) was created to meet the need for     comprehensive, scientific assessment of devices, treatment protocols, surgical approaches,     and patient factors influencing the results of hip and knee replacement surgeries.     Importantly, it is a Level 3 registry, meaning it collects and incorporates clinical     information and direct feedback from patients about the outcomes of hip and knee replacement     surgeries. It is one of only a small number of registries in the United States to do so.      The CJRR's goals are to:        -  Collect and report scientifically valid data on the results of hip and knee replacements          performed in California, including device safety and effectiveness, post-operative          complication and revision rates, and patient-reported outcomes; and        -  Promote the use of performance information regarding hip and knee replacements to guide          physician and patient decisions and to support programs for provider recognition and          reward.      Specifically the CJRR is designed to:        -  Minimize burden on participants by using electronic data sources, rather than manual          data entry or chart review.        -  Compile reports assessing the outcomes associated with different devices and surgical          techniques.        -  Create benchmarking reports for physicians and hospitals that detail performance data          and compare it to statewide averages.        -  Transmit safety alerts on devices with short-term results that provoke concern.        -  Shape a measurement and reporting system for total hip and total knee replacement          surgeries.      The CJRR was developed by the California HealthCare Foundation (CHCF), the Pacific Business     Group on Health (PBGH), and the California Orthopaedic Association (COA). PBGH manages the     day-to-day operations of the CJRR.      CJRR's data elements are aligned with other major orthopedic registries. The CJRR is a member     of the International Consortium of Orthopedic Registries (ICOR) and the International Society     of Arthroscopic Registries (ISAR).   "
114449|NCT01787799|"     The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound     (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System     (SYNERGY Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in     length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by     visual estimate).   "
114450|NCT01787786|"     The purpose of this study is to develop a predictive model that will allow optimized dosing     of infliximab for individual patients   "
114451|NCT01787773|"     This is a prospective, multicenter single arm, nonrandomized study that will include 150     patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months     to complete enrollment. Follow-up will continue through 24 months post-implant or one month     post-retrieval, whichever occurs first. It is required that filters be retrieved from at     least 50 patients and the filter is permanent in at least 50 patients.   "
114452|NCT01787760|"     This study is to investigate whether novel soft contact lens optical designs can slow myopia     progression.   "
114453|NCT01787747|"     To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of     AVP-786 in healthy volunteers.   "
114454|NCT01787721|"     The purpose of this study is to determine if manipulation of the ankle improves some     measurable characteristics of how a person walks. The investigators hypothesize that the     ankle will be able to bend better after manipulation and thus improve walking speed and     reduce differences between the two limbs.   "
114455|NCT01787708|"     Vitiligo is a chronic acquired disease characterized by well defined white macules and     patches affecting the skin. There are many treatment modalities available for vitiligo,     however, none of them cure the disease. Visible red light has been shown to stimulates     melanocyte migration and proliferation resulting in repigmentation of vitiligo patches.     However, there are only a few studies published on the efficacy of red light in vitiligo.     This is a prospective single-blind randomized clinical trial to assess efficacy of red light     in the treatment of vitiligo.   "
114456|NCT01787695|"     Vitiligo is a chronic acquired disease characterized by well defined white macules and     patches affecting the skin. There are many treatment modalities available for vitiligo,     however, none of them cure the disease. Ultraviolet A1 (UVA1) phototherapy has been shown to     be useful for a variety of skin diseases. However, there are only a few studies published on     the efficacy of UVA1 in vitiligo. This is a prospective single-blind randomized clinical     trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.   "
114458|NCT01787669|"     The specific aim of the study is to test the following hypothesis:      That switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with     diabetic macular oedema with no or incomplete response from one therapy is beneficial.   "
114785|NCT01783392|"     This clinical trial testing three different sites of transcutaneous electrical nerve     stimulation for the treatment of overactive bladder (OAB).   "
121105|NCT01699724|"     The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and     without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition     with water in Healthy Japanese Subjects   "
114459|NCT01787656|"     Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival     are low. There is a current belief that this cancer starts in the fallopian tubes and     progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian     tubes and the uterus, there is a constant flow of mucus which has only one exit through the     cervix and out the vagina. Proteins that are generated within the entire female reproductive     system are trapped into this viscous fluid and eventually released as waste. When a routine     PAP test is performed, a sample of this mucus is collected along with any cells, and     preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile     showing of the status of the cells in the female reproductive system. We have examined this     fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian     cancer when compared against healthy controls. These markers will be initially refined using     the comparison of ovarian cancer patients against those with benign adnexal masses that     entered the clinic during the same time period.      In this Phase II biomarker validation study we will further refine and validate these     biomarkers using a new collection of samples from at least 200 ovarian cancer cases with     epithelial ovarian cancer (endometroid and papillary serous histology, most common) and     comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the     clinics during the same time period. Patient samples will be collected on their first visit     to the gynecologic oncologist at a number of collaborating clinics. Final processing of all     of the samples will be performed within the proteomics research facilities of the Mitchell     Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on     the refined set of makers statistically selected within the first aim. Biomarkers validated     within this study will be compared with the well accepted CA-125 data for the patients. The     research involves a three year validation and may allow detection of this cancer at a very     early stage when the survival is as high as 90%. One aim examines a self-taken test that     could allow its use in medically underrepresented and rural areas.   "
114460|NCT01787643|"     The purpose of this research study is to determine whether height-adjustable desks change     sitting and standing time at work and away from work, engery expenditure, dietary intake, and     body composition. Intermittent peroids of standing made possible by height-adjustable desks     may help to impart long-term health benefits.   "
114461|NCT01787630|"     The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the     rectum could be completely moved out of the treated volume, a substantial decrease of rectal     toxicity seems reasonable. In this study we will develop and evaluate a new transrectal     injection technique where hyaluronic acid (HA) is injected in the space between the prostate     and the rectum prior to external beam radiotherapy to increase the physical distance between     prostate and rectum.   "
114462|NCT01787617|"     The purpose of this study is to investigate the effect of an exercise training intervention     on the ability of African American males to use insulin properly. Insulin is a hormone that     helps the body use glucose.   "
114463|NCT01787604|"     Authors hypothesize that aortic root reimplantation procedure is superior over standard     aortic valve reimplantation procedure in the incidence of aortic valve replacement.   "
114464|NCT01787591|"     This study is conducted to investigate if vitamin E status in healthy individuals and     individuals with metabolic syndrome can be improved by dairy fat. The investigators     hypothesize that full-fat dairy will substantially increase the bioavailability of     alpha-tocopherol, a form of vitamin E. The results of this study will contribute to the     application of dairy fat as a simple and effective strategy for improving vitamin E status,     which is partly due to poor vitamin E intake. By completing this study, the investigators     anticipate developing new dietary recommendations to achieve adequate vitamin E status     through the regular consumption of dairy fat paired with foods containing vitamin E.   "
114465|NCT01787578|"     The purpose of this study is to assess the safety, tolerance, pharmacokinetics, and     pharmacodynamics of sobetirome, a selective thyroid hormone analog, in adult male X-ALD     patients.   "
114466|NCT01787565|"     The aim of this investigation is to determine whether the use of painPREMIER will     significantly improve function in patients with low back pain in an occupational health     clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of     back pain and associated problems in order to treat them most effectively.   "
114467|NCT01787552|"     The purpose of this phase Ib/II clinical trial is to: a) evaluate the safety of the     co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum     tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the     efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.   "
114468|NCT01787539|"     Taking into account the substantial doubts concerning the potential benefit of postoperative     part in the perioperative chemotherapy regimen we designed a study assessing value of this     approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive     combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and     better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen     will be tested in patients with locoregionally advanced gastric cancer with positive     pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will     be randomized to the postoperative chemotherapy or to the follow-up arm.   "
114469|NCT01787526|"     2-3% of the population participates in blood donation programmes. Traditionally, safety     issues in transfusion medicine have been concentrating on product and recipient safety.     Extensive efforts including strict donor inclusion criteria and testing for important     transmissible infections have substantially improved product quality. One of the most common     risks of blood donation is iatrogenic iron deficiency. It may affect up to 30% of regular     blood donors because each whole blood donation causes a loss of 200 to 250 mg of iron.     Although this has been known for at least 50 years, iron deficiency is not routinely assessed     or treated in this population. Contributing factors include donation frequency, lower weight     and female gender. Women have lower iron reserves and in premenopausal women, the daily     required amount of iron is higher than in men. Besides anemia, iron deficiency may lead to     fatigue and impaired cognitive and physical performance. Oral iron substitution is often     associated with significant gastrointestinal side effects leading to poor compliance. Today,     intravenous (iv.) iron preparations are well tolerated and allow the application of a large     dose of 1000mg in one visit. Our hypothesis is that in blood donors with iron deficiency     intravenous iron is feasible and preferable to oral iron because of its high efficacy and     optimal compliance with a similar safety profile that has been extensively studied in other     populations than blood donors.   "
114470|NCT01787513|"     A randomised controlled trial comparing Internet based cognitive behavioural therapy for     major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A     vs. Internet based cognitive behavioural therapy for major depressive disorder plus a     cognitive bias modification intervention (OxIGen) version B on symptoms of depression and     negative interpretation bias.   "
114471|NCT01787500|"     The goal of this clinical research study is to find the highest tolerable dose of vemurafenib     that can be given in combination with cetuximab and irinotecan to patients with advanced     cancer. The safety of this drug combination will also be studied.      Vemurafenib is designed to block BRAFV600 inside the cancer cells, which is involved in     cancer cell growth.      Cetuximab is designed to block proteins inside the cancer cell, which may prevent or slow the     growth of cancer cells and leads to cell death.      Irinotecan is designed to stop cancer cells from making new DNA (the genetic material of     cells). If the cancer cells cannot make DNA, they cannot divide into new cells and may die.   "
114472|NCT01787487|"     The goal of this clinical research study is to learn if the combination of ruxolitinib and     azacytidine can help to control myelofibrosis and myelodysplastic syndrome/myeloproliferative     neoplasm.      Ruxolitinib is designed to block a pathway that has been found to be overactive in human     cancers and myelofibrosis.      Azacytidine is designed to block certain proteins in cancer cells that stop the function of     the tumor-fighting proteins. By blocking the bad proteins, the tumor-fighting genes may be     able to work better.   "
114473|NCT01787474|"     The goal of this clinical research study is to learn about the safety and effects of giving     special kinds of immune cells, called natural killer (NK) cells, with high dose chemotherapy     to AML patients. Researchers want to learn the maximum tolerable number of NK cells that can     be given. These NK cells may react against the leukemia cells, particularly when they are     mismatched for certain HLA tissue type proteins.      In addition to NK cells, you will receive cytarabine and fludarabine to try to kill any     cancer cells and prevent rejection of the NK cells.   "
114474|NCT01787461|"     The study hypothesis is that Imedeen will show effects on skin health, when compared to     placebo over a 6 month intervention period with respect to changes in skin appearance, skin     density, moisture, and in fine lines and wrinkles.   "
114475|NCT01787448|"     This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its     vehicle gel to cause sensitization after repeated topical application to healthy skin of     human subjects under controlled conditions.   "
114476|NCT01787435|"     The purpose of this study is        1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs)          and the risk of asthma during childhood.        2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs)          and the risk of asthma during childhood.   "
114477|NCT01787422|"     This study is to determine if telemedicine visits provide similar quality and     patient/physician satisfaction as traditional office visits in a college health population.   "
114478|NCT01787409|"     This partially randomized clinical trial studies cholecalciferol in improving survival in     patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may     improve tumor response and survival and delay time to treatment in patients with cancer who     are vitamin D insufficient.   "
114479|NCT01787396|"     The objective of this study is to evaluate efficacy and safety of initial combination therapy     with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment     naïve patients with type 2 diabetes, In other words, to proof superiority of initial     combination therapy with Gemigliptin and Metformin than each monotherapy.   "
114480|NCT01787383|"     The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen     compared to a sequential treatment regimen when two separate areas with AKs (one located on     face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel   "
114481|NCT01787370|"     The goal of the flow-mediated constriction/ FMC-registry is to investigate whether the     measurement of endothelial function using flow-mediated dilation and flow-mediated     constriction provides on the presence of coronary atherosclerosis and on the prognosis of     patients undergoing coronary angiography.   "
114482|NCT01787357|"     The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on     electrocardiogram results (recordings of the electrical activity of the heart) in healthy     volunteers after a single therapeutic dose (300 mg) and a single supra-therapeutic dose (4     times higher [1,200 mg] than the anticipated therapeutic dose of 300 mg). The safety and     tolerability of canagliflozin will also be assessed.   "
114483|NCT01787344|"     To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South     Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral     palsy in children.   "
114484|NCT01787331|"     This study is being done to test an investigational drug called itraconazole in the treatment     of prostate cancer.   "
114485|NCT01787318|"     This research study designed to look at how well adolescents' and young adults' blood sugars     can be controlled with a closed loop artificial pancreas using a continuous glucose sensor,     an insulin pump, and a computer program that automatically determines how much insulin to     give based on the glucose level. The investigators will also study the effect of wearing a     small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the     closed loop system to control the blood sugar levels and to reduce the rise in glucose levels     after meals.   "
114486|NCT01787305|"     The purpose of this study is to explore if certain commensals within the gut microbiota (the     collection of all microbes that live inside the gut) correlate with autoantibodies in the     autoimmune clotting disorder called antiphospholipid syndrome. The study hypothesis is that     particular commensals induce the autoantibodies (immune molecules that bind to self     structures) and thus correlate with the level of immune cells and antibodies that are     self-reactive. Participants are patients with antiphospholipid syndrome and individuals who     have tested positive on a prior blood test for anti-beta2-glycoprotein I antibodies or those     that have tested negative for antiphospholipid antibodies in their blood, but had a clotting     event or a health problem that puts them at risk to form blood clots.   "
114487|NCT01787292|"     The purpose of this research study is to test whether differing levels of physical fitness     affects patterns of motor dexterity and brain activity that have been shown to differ due to     aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.      Participants will be healthy adults within the target age range of 60-85 for the study. The     study will require multiple visits over 15 months. There will be about 64 people volunteering     for this study.   "
114490|NCT01787253|"     Objective: This study aims elucidate the pathophysiological link between the environment in     the colon (mainly the microbiota), the local immune system and activation of the enteric     nervous system in patients with post-infectious IBS (PI-IBS) and microscopic colitis (MC)     with special emphasis on microbial-mucosa interactions and evaluation of the effect on the     immune activation/response as well as how afferent gut-brain signalling leads to abdominal     discomfort.      Method: The project is based on data from three cohorts of patients, one with PI-IBS and one     with MC as well as a gender- and age-matched cohort of healthy individuals. Measurement of     perceived sensitivity in the gut will be evaluated by pain-response under mechanical stress     using a barostat. The HIT (Human intestinal Tissue)-Chip array will be used to characterize     the diversity, stability and functionality of the intestinal microbiota on mucosa level,     giving a clue to the interactions with the host and insight to changes leading to the     development of the two diseases.      Immunohistochemistry and flowcytometry will be used to analyse the location, frequency and     phenotype characteristics of lymphoid- and mast cells. Functional analysis of mucosal     lymphocytes activated in vitro by products from the intestinal microbiota will be examined by     cytokine production using the LuminexTM system. The Ussing chamber technique will allow     investigation of the impact of the microbiota and its metabolites on intestinal barrier     functions. In this method the sample has access to stressors under standard conditions.   "
114491|NCT01787240|"     We are doing this research study to find out if people who get better while taking a specific     kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and     people who get better while taking placebo (an inactive substance) have similar chemicals in     their brains. Some participants may complete a procedure called Acute Tryptophan Depletion     (ATD), which is a way to study the role of serotonin in depression. Some participants may     also undergo a magnetic resonance-positron emission tomography (MR-PET) scan.   "
114492|NCT01787227|"     xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial     DNA / RNA in clinical specimens (nasopharyngeal swabs).      The objective of this study is to establish diagnostic accuracy of the xTAG RPP.   "
114493|NCT01787214|"     Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may     lead to a higher risk of developing heart disease. An important part of diabetes management     involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat,     protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to     compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels     of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM     will participate in the study. Subjects will be randomized to consume an ADA diet with or     without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar     twice daily and wear a continuous glucose monitor during the three 72-hour study periods.     Subjects will be between 40 and 70 years of age and will be recruited from the surrounding     community using flyers and public service announcements. Consent will take place in the     Department of Nutrition at Loma Linda University by the study investigators. In total,     subject participation will last 5 weeks and all meals will be provided during the 3 study     periods.   "
114494|NCT01787188|"     The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and     effective for the treatment of osteoarthritis pain of the knee or hip.   "
114495|NCT01787175|"     The purpose of this study is to advance the science of healthcare informatics and to improve     medication management through the development of a new approach to the electronic medical     record called the Integrated Medication Manager (IMM).   "
114496|NCT01787162|"     Goal of the study is to assess the frequency of pulmonary hypertension in patients with     chronic myeloproliferative diseases. In each patient an echocardiography at rest will be     performed. In patients without musculoskeletal disease an exercise test (spiroergometry) will     be performed. Patients with elevated SPAP at rest or with reduced exercise capacity (peak VO2     < 65%) a right heart catheterization (RHC) will be recommended. Also patients with advanced     NYHA functional class (III or IV) or with typical PH findings in electrocardiogram will be     advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6 MWD will     be performed.      This work- up of patients allows clinical and hemodynamic evaluation.   "
114497|NCT01787149|"     A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,     Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with DMARDs     versus DMARDs Alone in Patients with Rheumatoid Arthritis   "
114498|NCT01787136|"     Dextromethorphan added on methylphenidate for the patients with attention deficit     hyperactivity disorder   "
114499|NCT01787123|"     This is a randomized, placebo-controlled, single-center clinical trial investigating the     effectiveness of administrating intravenous Cerebrolysin™ (EVER NEURO Pharma, Austria), a     preparation of low-molecular weight neurotrophic peptides and free amino acids, in improving     the functional outcome of patients suffering from aneurysmal subarachnoid haemorrhage ( SAH).      Cerebrolysin™ is a porcine-derived intravenous formulation composed of multiple lipid-soluble     active agents that can cross the blood-brain barrier. It is a registered medication in     several countries indicated for stroke and Alzheimer's disease. It contains several low     molecular weight neuropeptides and free amino acids that possess neuroprotective and     neurotrophic properties. It has been proven to arrest or mitigate several crucial steps along     the ischemic cascade in preclinical studies. Cerebrolysin™ has been extensively investigated     in patients suffering from Alzheimer's disease, brain trauma and ischemic stroke with     promising clinical results. It's use in SAH patients has never been investigated and it is     believed that it may play a role in improving clinical outcomes.      Consecutive patients aged 18 to 70 years-old diagnosed to have spontaneous subarachnoid     hemorrhage secondary to a ruptured intracranial aneurysm will be randomly allocated into one     of two study arms: (1) to receive intravenous Cerebrolysin™ in additional to standard of care     (intervention group) or (2) to receive usual standard of care alone (control group).     Permuted-block randomization will be carried out once the eligibility criteria have been     fulfilled using a computer system with an allocation list of random order. Instructions on     study arm allocation will be contained in sealed envelopes labeled with sequential study     numbers. Patients presenting beyond 96 hours after onset of symptoms or if recruitment and     randomization cannot be performed within this time period will be excluded. The reason being     that post-SAH arterial vasospasm and delayed cerebral ischemia usually occurs four days after     aneurysm rupture and lasts for two weeks i.e. 14 days. Should this complication arise before     Cerebrolysin™ is administered there would be significant confounding of trial outcome     measures . The timing of intervention is in keeping with several landmark clinical studies     that have dealt with neuroprotective agents in subarachnoid hemorrhage.      Patients in the intervention group will receive in a daily total dose of 30ml of intravenous     Cerebrolysin™. The study medication will be administered in three separate 10ml doses (every     eight hours) diluted in 0.9% NaCl saline to a total volume of 100 ml as an intravenous     infusion over a time period of 15 minutes. An identical amount of 0.9% sodium chloride (NaCl)     saline (100 ml) will be used as placebo for patients allocated to the control study group.     The total duration of study medication or placebo administration will be 14 days.      Cerebrolysin™ is a clear yellow solution. Since it is susceptible to photo-degeneration the     preparation after dilution with 0.9% NaCl saline requires masking with a opaque plastic wrap     as well as special photo-protective infusion sets. The dilution of the Cerebrolysin™ solution     will be performed by ward nursing staff . Subjects in both trial groups will receive     identically wrapped preparations so that both the functional outcomes assessor and patient     are blind to the study arm allocation.      In addition to general demographic data, clinical data including the admission Glasgow Coma     Score, severity grading of SAH, hospital stay as well as the extended Glasgow Outcome Score     and modified Rankin Score upon discharge, at three months and six months will be     prospectively collected. The functional outcomes assessor will be an occupational therapist     unaware of the subject's trial group allocation.      Hypothesis: compared to patients receiving standard care for the management of aneurysmal     subarachnoid hemorrhage alone (control), the additional administration of intravenous     Cerebrolysin™ (intervention) within the acute phase of stroke is safe and improves functional     outcome at six months after stroke.   "
114500|NCT01787110|"     The use of supplemental oxygen in the setting of suspected acute myocardial infarction (AMI)     is manifested in international treatment guidelines and established in prehospital and     hospital clinical routine throughout the world.      However, to date there is no conclusive evidence from adequately designed and powered trials     supporting this practice. Existing data is conflicting and failing to clarify the role of     supplemental oxygen in AMI.      The DETO2X-AMI trial is designed to shed light on this important issue.   "
114522|NCT01786824|"     The general objective of this open, pilot study is to characterize biological parameters     related to acute kidney injury among patients undergoing a programmed coronarography with     injection of contrast material. The study focuses on two main factors that may influence     acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate     hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral     L-carnitine treatment. We will also test for a potential interaction between these two     factors.   "
114523|NCT01786811|"     The purpose of the study is to evaluate the impact of implementing a Serious Illness     Conversation Guide to guide patient/family-clinician discussions and planning about     end-of-life care decisions. The goal of the intervention is to improve achievement of patient     care priorities and peacefulness at the end of life for patients with serious and     life-threatening illness and their families. We hypothesize that patients whose physician is     trained to use and adheres to the elements of the Serious Illness Conversation Guide will     demonstrate enhanced consistency between documented key priorities and care received, and     will experience greater peace in the final month of life; similarly, their families will     experience higher satisfaction with care.   "
114501|NCT01787097|"     The purpose of the research (or knowledge gap this research is designed to fill) is to     understand the science of how the combination therapy of 2 drugs (inhaled longacting     beta-agonists(LABA) and inhaled corticosteroids (ICS), which are commonly used in chronic     obstructive pulmonary disease (COPD) patients, is better than each drug alone. ICS and LABA     both have antiinflammatory properties; that is, they dampen the inflammation in the cells of     the airways in the lungs. The combination of LABA and ICS has also been shown to improve     clinical effectiveness in asthma patients. The addition of a LABA to LOW doses of ICS has     been shown to be more clinically beneficial in asthma than the use of HIGH doses of ICS     alone. This has allowed a reduction in the total ICS dose and minimised the adverse side     effects of inhaled corticosteroids. Recent evidence suggests that the use of combination     therapy of LABA and ICS may also improve clinical effectiveness in COPD patients.      Investigators will address this hypothesis by examining the inflammation cells of COPD direct     from the site of disease (the airways) by looking at sputum/mucus. This research will build     on the existing knowledge of the science of how these drugs work in asthma and COPD and     allows us to understand the molecular science, which may support new future drug targets for     patients with COPD, which are greatly needed.   "
114502|NCT01787084|"     Investigational study of Edwards Lifesciences, LLC's Edwards SAPIEN Transcatheter Heart     Valve for non-femoral delivery, (or alternative access deliver) in patients with severe     symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be     inoperable for open aortic valve replacement and in whom existing co-morbidities would not     preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed     in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN     device compare to inoperable patients undergoing alternative access TAVR with the Edwards     SAPIEN device experience a reasonably similar incidence of 30 day adverse events?   "
114503|NCT01787071|"     Fluids are one of most common therapies used in critically ill patients. Fluids are the     cornerstone of hemodynamic management. In overt bleeding, fluids are often given without     guidance with specific haemodynamic monitoring. In other conditions when hypovolemia may be     more subtle or when the response to fluids is more variable, fluids are often given in a more     titrable way, monitoring their haemodynamic impact. This practice, called the fluid challenge     technique has been proposed by Max Harry Weil more than 30 years ago [1].      The fluid challenge has been used in several papers and studies assessing the response of     patients to fluids. The way this practice is performed varies in terms of type of fluid,     volume of fluid, rate of fluid administration, and clinical endpoints used.      There is no data that describe how fluid challenges are administered in ICU's across the     world. Understanding this will provide valuable information regarding current practice and     would be a basis for improving current practice and future research.      The way fluids are administered vary widely. Indications for fluids and monitoring of the     effects are not standardized and may thus lead to heterogeneity in practice. In addition,     several patients may fail to respond to fluids. The purpose of this observational study is to     evaluate how fluids are administered and to identify the factors associated with a positive     response to fluids. Better characterizing these practices and the patients who benefit from     fluids would set the basis of further interventional trials trying to optimize fluid     administration.      What does this study involve?        1. All patients enrolled in the study will receive standard clinical care        2. Data will be collected in order to study how fluid challenges are performed in ICU's        3. No extra tests will be performed for this study        4. Only measurements and data available as part of clinical practice will be collected   "
114504|NCT01787058|"     This study will use longitudinal data collection to quantify the impact of a school-based     water, sanitation and hygiene (WASH) program in Mali, West Africa, on pupil absenteeism,     diarrheal illness, and respiratory illness.      Data will be collected from 100 intervention and 100 control schools across 4 regions in     Mali. At each school research staff will randomly select 60 pupils in grades 3-6 (typically     ages 7-14). Research staff will ask school directors to provide written consent for pupil     participation in place of parents, a procedure that has been approved by the Malian Ministry     of Education. Research staff will approach selected pupils at school to request informed oral     assent for participation. The informed assent process and data collection will be conducted     by local trained enumerators in the child's preferred language of French or Bambara. Oral     rather than written assent was chosen due to varied literacy capabilities and to limit     paperwork that identifies participants.      Data collection will take place at each school once every six to eight weeks during the     duration of two school years. Research staff will conduct observations of school facilities,     observations of handwashing behavior of children upon leaving latrines, and an interview with     the school director about WASH conditions and school enrollment information. None of these     school activities collect personal data or identifiers. Data collection with pupils will be     done with the same pupils every 6-8 weeks and entails a 5-minute interview asking about     recent absence and symptoms of diarrhea and respiratory illness.      All data collection will occur at the school, will be conducted by trained local enumerators,     and will be stored on password-protected mobile data collection devices. Data will be     uploaded to a password-protected server and will not contain personal identifying     information. Enumerators will maintain a separate form that links pupil IDs with names, which     will be kept confidential. There are no direct benefits other than contribution to general     knowledge that will inform future school WASH projects. There are no risks to participation     other than a small amount of class time missed by pupils, and great efforts will be made to     minimize time outside of class.   "
114505|NCT01787045|"     It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or     multi organic failure are very susceptible to develop neuromuscular complications. That can     be attributed to a hyper catabolic state, general inflammation and immobilization. This can     leads a significant muscle wasting, polyneuropathy and/or myopathy. These alterations have     been defined with the term Intensive Care Acquired Weakness (ICUAW) and can leads important     functional squeals and impaired quality of life for months, years and in some cases     irreversibly.      To overcome these complications, early activation by physiotherapy becomes an important tool.     This type of treatment has been show to be feasible, safe and improves the functional     capacity of patients. In addition to a reduction in the duration of ICU and hospital stay and     improved quality of life for patients.      The objective of this study is to demonstrate that the early and active physical activity in     patients with severe sepsis can limit the loss of muscle mass and complications related to     this type of damage.      Procedures: Patients or relatives will be asked to participate in the study. If a positive     response is done, patients will be randomized in an intervention or control group.      A baseline evaluation will be performed during the first day of study admission. That     includes a physical exploration, electrophysiological studies, skeletal muscle     histological/biochemical evaluations and monitoring of blood biomarkers and others clinical     outcomes will be registered.      Intervention will be divided in a morning and afternoon times, patient will be positioned in     chair or bed and mobilized by physiotherapist. As usual, all patients will be attaining     manual mobilization for 20 minutes twice a day. Only for intervention group, additional     cycle-ergometer exercise will be performed for 30 minutes at better performance achieved and     tolerated for patient. All vitals parameters will be strictly controlled before, during and     after intervention.      The same baseline evaluation will be repeated after day 7 and clinical outcomes will be     registered until ICU discharge.   "
114506|NCT01787032|"     The primary objective of this trial is to investigate the relative bioavailability of a     single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state.     The assessment of safety and tolerability of BI 113608 administered alone and upon     co-administration will be an additional objective of this trial.   "
114507|NCT01787019|"     The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed     to tube) feedings in premature infants results in earlier attainment of full oral feedings     and/or discharge.   "
114570|NCT01786200|"     This prospective pilot study will examine whether the previously reported effects of NSAIDs     on colorectal cancer may be modulated through alterations in tissue gene expression, up     regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory     response.   "
130241|NCT01580254|"     This study examines efficacy and tolerability of 3 different Latanoprost 0.005% eyedrops     preparations, commercially available in Italy, in subjects affected by primary open angle     glaucoma.   "
114508|NCT01787006|"     Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from     chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall     survival rates for this disease remain poor.      During the last years the combination of cetuximab with standard chemotherapy or radiotherapy     has mainly be investigated in clinical trials focusing on colorectal and/or head and neck     cancer.      The results obtained from theses studies were very encouraging and led to the initiation of     active clinical research in esophageal cancer patients with antibody inhibition of the EGFR.      The first data in this indication are encouraging showing that cetuximab can safely be added     to chemoradiation for esophageal cancer patients with first hints of efficacy.      Based on the experiences with cetuximab in colorectal cancer and in combination with     radiotherapy in head and neck cancer, the aim of the present study is to evaluate the     feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin     and radiotherapy in patients with esophageal cancer and to assess if the overall survival     rates can be increased by addition of an EGFR-targeted therapy.   "
114509|NCT01786993|"     This IDE study is a prospective, randomized, double-blind, multi-center clinical study to     evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment     with standard BiV pacing at 9 months.      The study will be conducted at a maximum of 50 investigational centers located in the United     States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization     therapy device (CRT-D) system will be enrolled in the study.   "
114510|NCT01786980|"     Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after     curative resection. Establishing an effective prognostic evaluation method is able to not     only assess patients' prognosis but also guide the treatment. At the same time, it helps us     to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and     to provide the basis for the search for new effective intervention method.      In order to establish an effective prognostic evaluation method, we select liver cancer     patients undergoing curative resection in our hospital. We plan to employ various     technologies such as gene chip, methylation chip and flow cytometry to carry out     comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor     microenvironment changes. By analyzing clinical information including pathological features,     patients' response to treatment, relapse, metastasis and survival, we aim to obtain the     important factors affecting liver cancer prognosis, survival, recurrence and metastasis in     order to be able to find and establish the effective prognostic evaluation method.   "
114511|NCT01786967|"     Urge urinary incontinence, characterized by unpredictable and embarrassing large volume urine     leakage, is a major health issue for elderly women, as it is incredibly common and     significantly impairs quality of life. Although anticholinergic medications are the most     common therapy, the investigators are unable to predict an individual's response to a     particular drug in terms of both effectiveness and side effects. Through genetic evaluation,     the investigators have the potential to personalize and optimize drug therapy for millions of     elderly women suffering from urge incontinence.   "
114512|NCT01786954|"     The purpose of the study is to compare the measurement of pressure inside the eye using three     different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).   "
114513|NCT01786941|"     Elevated circulating levels of certain amino acids (the building blocks of protein) are     strongly associated with insulin resistance. This study will investigate the metabolism of     these amino acids in individuals with normal glucose metabolism compared to overweight or     obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels     of the branched-chain amino acids may contribute to the development of insulin resistance and     ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass     (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as     insulin sensitivity improves. This information will be used to further our understanding of     the development of insulin resistance and type 2 diabetes in at-risk populations and     potentially improve clinical treatment of such conditions.   "
114514|NCT01786928|"     The purpose of this study is to determine whether resistance exercise are effective in     combating the decline in muscle strength during an exacerbation of Chronic Obstructive     Pulmonary Disease (COPD).   "
114515|NCT01786915|"     The purpose of this study is to assess the study medication blood levels after administration     of a repeat oral capsules (one capsule each day for seven days) of Bendavia at one of two     dose levels. The effects of Bendavia on the volunteers will also be assessed.   "
114516|NCT01786902|"     Growth hormone therapy will improve the height of idiopathic short statured children.     DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to     non-treatment group in efficacy and safety.   "
114517|NCT01786889|"     The purpose of this study is to test the feasibility of identifying incident cases of     angiosarcoma of the liver from the network NetSarc.   "
114518|NCT01786876|"     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,     pharmacokinetics, safety and tolerability following a single oral administration of [14C]     SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study     is to investigate how and how quickly SPD557 or its break down products are excreted by     analysing blood, faeces and urine samples collected during the study.   "
114519|NCT01786863|"     This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB)     in the pediatric population.   "
114520|NCT01786850|"     Patients with unresectable pancreatic cancer in most of cases cannot benefit from     percutaneous ablation modalities, due to high risk of procedure-related complications.     Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a     feasible treatment option in these patients. However, in other anatomical regions US-guided     HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation,     but the applicability of this latter technique to the treatment of pancreatic cancer is still     unexplored. The aim of this study is to explore feasibility and clinical performance of     MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain     palliation and local tumor control.      As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate,     non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no     cases of pancreatic MRgFUS ablation have been reported.   "
114525|NCT01786785|"     Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top     ten causes of death in children. Currently, caregivers lay the affected child flat in hopes     of increasing blood flow to the brain and reducing the volume of the brain which is damaged.     However, there are currently no techniques to measure brain blood flow at the child's bedside     and indicate if this treatment is effective. We will probe brain blood volume, oxygen     saturation, and flow with red light to determine the efficacy of this intervention.   "
114526|NCT01786772|"     To determine changes in quadriceps muscle function following the application of ice and     compression to the knee.   "
114527|NCT01786759|"     The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought     to be multifactorial, and proposed theories also include problems arising from lipid     emulsions, leading us to explore alternative products available elsewhere.So we compare the     different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic     tolerance in preterm infant.   "
114528|NCT01786746|"     The goals of this study were to a) test whether cognitive behavioral therapy (CBT) is     effective in treating depressed Chinese Americans, b) to develop and test the effectiveness     of culturally adapt CBT, and c) to test the differential outcomes of the two treatments.   "
114529|NCT01786733|"     The purpose of this study is to compare the effectiveness of Behavioral Activation and     Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts     during inpatient care and can continue in an outpatient facility if the patients are     discharged before 12 sessions has been completed.   "
114530|NCT01786720|"     The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease     (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these     following research questions:        1. The percentage of patients prescribed triple therapy, and when they first started          receiving triple therapy.        2. For patients prescribed triple therapy, the time taken to triple therapy from initial          diagnosis of COPD.        3. The variation in treatment pathways.        4. The factors associated with time taken to triple therapy.   "
114531|NCT01786707|"     A prospective, open labeled, randomized controlled clinical trial comparing the benefit of     both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical     treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical     treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be     randomized into either the intervention group or the control group:   "
114532|NCT01786694|"     The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in     order to identify anastomotic leaks after rectal surgery.   "
114533|NCT01786681|"     The aim of this study was to investigate the effects of using positive pressure in the     preoperative, intraoperative and postoperative morbidly obese individuals undergoing     gastroplasty.      It is believed that the application of these devices before, during or after surgery can help     to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.   "
114534|NCT01786668|"     This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It     is designed to obtain information on the efficacy and safety of 3 different doses of     tofacitinib.   "
114535|NCT01786655|"     The primary aim of this Phase 1 study is to evaluate the systemic safety of a novel     prolonged-duration local anesthetic, Neosaxitoxin (NeoSTX), given by subcutaneous injection     in combination with the commonly used local anesthetic, bupivacaine, and epinephrine.      The investigators hypothesize that a minimal adverse effect threshold NeoSTX dose for     subcutaneous administration in combination with bupivacaine 0.2% and epinephrine 5mcg/ml     respectively, can be defined for awake, young adult healthy volunteer subjects. At the same     time, the pharmacokinetics of NeoSTX when delivered subcutaneously will be determined.   "
114536|NCT01786642|"     The aim of the present study is to measure the time to correction of O2 saturation when in     case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal     route at a similar flow rate.   "
114537|NCT01786629|"     To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved     control as bowel preparations prior to colonoscopy in adult patients.   "
114538|NCT01786616|"     Polymorphism at codon 16 of the beta2-adrenoceptor (beta2-AR) affects the responsiveness to     salmeterol in asthmatics. Data concerning formoterol are more controversial in literature.     The aim of this study was to verify whether homozygote for arginine-16 (ArgArg16) and     homozygote for glycine-16 (GlyGly16) genotypes differently influence the long-term     responsiveness to formoterol.   "
114584|NCT01786018|"     The purpose of this study is to evaluate progression free survival, transplant-related     morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic     GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated     with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.   "
114660|NCT01785017|"     A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented     at Boston Children Hospital to decrease variations in clinical practice in critical asthma     therapies for children. The primary aim is to determine whether a Critical Asthma SCAMP can     improve clinical outcome.   "
118845|NCT01730339|"     The study will compare how well PF-06473871 works versus placebo in reducing skin scarring     after scar revision surgery of existing breast scars. The study will also evaluate the safety     of PF-06473871 in healthy adult subjects.   "
114640|NCT01785290|"     The aim of this study is to determine the effects of a low dosage of prophylactic haloperidol     in patients with a high risk to develop delirium, defined by an expected ICU length of stay     of >1 day. The investigators hypothesized that haloperidol prophylaxis in patients with a     high risk for delirium reduces 28-day mortality, delirium and delirium related outcome.      Two different dosages of haloperidol are used in this study to compare with placebo. A dosage     of 1mg, or 2mg or placebo three times a day in a double-blinded fashion resulting in a     three-armed multicentre randomized double-blinded placebo-controlled trial. To relate the     potential beneficial effects of haloperidol to the a priori risk to develop delirium, the     PREDELIRIC-model (delirium prediction model for ICU patients) will be used. This will enable     the investigators to determine the preventive efficacy of haloperidol in patient groups based     on their risk to develop delirium.   "
114539|NCT01786603|"     ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons     in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and     loss of muscle function. Motor neurons are responsible for sending signals to muscles in our     bodies to trigger movement. While there are drugs to help relieve symptoms of ALS, there is     no cure for ALS.      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means     that the nervous system may be protected against weakening. It is known that rasagiline has     possible neuroprotective characteristics, but the effectiveness of rasagiline for patients     with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's     disease.      Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration     (FDA) and is investigational. Investigational drugs are studied to find out if they are safe     and effective in the treatment of diseases or conditions.      By doing this study, researchers hope to learn if rasagiline is safe and slows disease     progression in patients with ALS.      Funding Source - FDA OOPD.   "
114540|NCT01786590|"     It is reported that more than 90,000 patients died of lung cancer and more than 20% of them     were older than 80 years in North America. Therefore a less invasive but effective treatment     is required for patients with lung cancer of advanced age, diminished pulmonary functions,     and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and     well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the     other hand, accurate mediastinal and hilar lymph node staging is one of the most important     factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided     transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that     enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate     lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung     cancer to undergo minimally invasive treatment.   "
114541|NCT01786577|"     The purpose of the study is to examine specific neuroimaging predictors of memory and     executive decline in older adults at various stages after total knee replacement surgery.   "
114542|NCT01786564|"     The purpose of this study is to determine if deficient sleep and/or disruption with the     body's internal clock (circadian rhythms) are associated with diabetes risk. This study is     being done to look at the possible relationships between sleep and risk of diabetes by     examining sleep in the home and diabetes risk in the laboratory.   "
114543|NCT01786551|"     The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR)     blockade in healthy participants in a systemic proinflammatory state after a meal high in fat     and glucose, which is associated with the pathogenesis of atherosclerosis.      Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m^2)     between the ages of 18-45, without hypertension and clinical evidence of metabolic,     cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be     assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test     (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks,     participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to     the first intervention (day1), the participant's usual diet (ad lib) will be supplemented     with 2 bullion broths each day. Standardization of sodium intake is necessary as variations     in dietary sodium intake may affect outcome measures. We will evaluate the following     parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we     will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).   "
114544|NCT01786538|"     Regorafenib has been proved to improved survival in patients with metastatic colorectal     cancer who have been failed to all of known standard chemotherapy (The CORRECT study). The     phase Ib study of regorafenib plus FOLFOX or FOLFIRI was performed and the dose of     regorafenib was fixed; 160 mg/day on days 4 to 10 (7 days per cycle when combined with FOLFOX     or FOLFIRI). Regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who     progressed after first-line irinotecan-based chemotherapy has not been studied yet, and     because there have been unmet needs for the discovery of valid targeted agent combination for     the second-line FOLFOX as above reasons, the investigators planned this study of regorafenib     plus FOLFOX as second-line chemotherapy in mCRC patients who progressed after first-line     irinotecan-based chemotherapy.   "
114545|NCT01786525|"     The main purpose of this research program is to reduce the burden of end-stage organ disease     on individuals, families, healthcare systems, and society by increasing the availability of     donor organs for transplantation. Consistent with this aim, the project further examines     strategies to increase access to and reduce disparities - racial, economic, gender - in live     donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of an     innovative House Calls intervention developed by the principal investigator by including     other minorities and socioeconomically disadvantaged patients and by adding a novel     Patient-Centered Decision Support component. The main study hypothesis is that participants     receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have     a higher proportion of LDKT's by the 2-year study endpoint.   "
114546|NCT01786512|"     The primary objectives of this study are (i) to select an oral modified release (MR)     formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects     with HF and left ventricular systolic dysfunction and (ii) to characterize its     pharmacokinetics (PK) over 20 weeks of treatment.   "
114592|NCT01785914|"     This study provides for the collection of a series composed by patients with newly diagnosed     of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with     retrospective investigation, through the review of paper and electronic records and data     cards in large part already collected as part of study protocols GIMEMA or BFM or NILG     approved by the Ethics Committee of Hospital. The purpose of data collection is to check with     retrospective predictability of classical risk factors in relation to disease response, and     overall survival of the event-free survival, to estimate the cumulative incidence of     competitive events such as the emergence of disease, acute and chronic transplant, the     transplant-related mortality and relapse of disease.   "
114593|NCT01785901|"     This is a multi-centre, cross-sectional study planned to be conducted in China. The study     aims to observe about 1500 asthma patients who have already received budesonide/formoterol     combination treatment by physicians' determination and whose medications are aligned with the     package insert of budesonide/formoterol approved in China.   "
114547|NCT01786499|"     Hypothesis: Relaxation Response training is an effective intervention in reducing the     prevalence and severity of burnout and its components from baseline levels among physicians     receiving the training intervention. The intervention is hypothesized to moderate the     relationship between Areas of Worklife (AWS) and burnout by improving physician's ability to     cope with the demands of their workplace. This increased coping ability is hypothesized to     reduce burnout.      Physician practices are as unique as the individual practitioners and the environment in     which they practice. Traditional instruction of relaxation or self-care techniques has     required participants to travel to locations remote from the workplace. The time commitment     required for this behavior is additive to the time required to learn the intervention and of     itself may induce extra stress increasing the potential for burnout. This study proposes that     bringing the intervention to the workplace will increase provider willingness to participate     and diminish the stress introduced by deployment of the intervention. Since inpatient and     outpatient medicine have different practice characteristics and demands on the time of the     practitioners, this study will need to develop and test the logistics necessary to bring the     training to the different physician populations.   "
114548|NCT01786486|"     The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to     evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in     subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more     years post implant.   "
114549|NCT01786473|"     The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel     administered once daily (QD, morning dosing) compared to placebo administered once daily (QD,     morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being     confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment     aims to restore testosterone levels to normal physiological range.   "
114550|NCT01786460|"     The purpose of this study is to use an investigational assay to assess levels of putative     biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in     a correlative analysis with data collected under a separate study of severe TBI.   "
114551|NCT01786447|"     The purpose of this study is to determine if specific brain injury biomarkers have utility as     blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be     accomplished by examining the relationships between potential serum-based TBI biomarkers and     clinical measures of injury severity, occurrence of complications, and outcome, in subjects     with mild or moderate TBI as well as in orthopedic control subjects.   "
114552|NCT01786434|"     Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely     administered in most countries. In Norway, however, routine sedation is rare, and medication     is normally given on demand, that is, if necessary during the procedure. The investigators     want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of     action, is better given before the procedure than during the procedure.   "
114553|NCT01786421|"     The purpose of this study is to determine the impact of alcohol consumption in diurnal     triglyceridemia in a free living situation.   "
114554|NCT01786408|"     This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The     TAP20-C device collects small amounts of blood from the forearm which can then be used for     blood testing. The study will also involve collecting blood by fingerstick which is a common     way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo     Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the     concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two     different blood collection methods. Additional information will be collected about how the     TAP20-C device performs.   "
114555|NCT01786395|"     This study is a multicenter trial performed in Japan, consisting of a comparative study     period and a continuous administration period.      Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will     be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study     in patients with retinitis pigmentosa.      The safety of same eye drops will also be examined in 52 weeks continuous administration     period, in all the patients who completed the comparative study period.   "
114556|NCT01786382|"     The primary objectives of the study are to:        -  Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK)          profile of midazolam following a single oral dose in human subjects.        -  Evaluate the potential effects of PPI-668 at steady state on the PK profile of          omeprazole following a single oral dose in human subject   "
114557|NCT01786369|"     This is a screening study aimed at estimating the frequency of antipsychotic non-compliance     in patients with a history of schizophrenia or other psychotic disorder admitted to an     inpatient psychiatric unit. Levels of the antipsychotics risperidone, olanzapine, quetiapine,     aripiprazole, and paliperidone will be drawn in patients presenting the emergency room who     are acutely psychotic, require admission to an inpatient hospital, have a history of     psychosis, and have previously been prescribed one of the study drugs. Levels will then be     analyzed to determine the frequency and severity of non-compliance in this population.   "
114580|NCT01786070|"     The aim of this study is evaluation of the effect of administration nebulized budesonide     after extubation. The specific objectives of our study are to determine whether multiple     doses of nebulized budesonide are effective to reduce or prevent postextubation edema.      In this double-blind randomized clinical trial study, 70 patients (age between 18 to 65) who     are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in     the study after obtaining a written informed consent from their parents or guardians.      The investigators divide our patients randomly into two equal groups.      -Patients who are in budesonide group will receive nebulized budesonide (1 mg-every 12 hours;     n=35) and patients in placebo group receive placebo (normal saline; n=35) until 48 hours     after extubation. If patient have extubation criteria the investigators will extubate him and     for 24 hours after, another anesthesiologist who is unaware about kind of medication, will     evaluate the patients for severity of stridor. We will record the vital sings and grade of     stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen     saturation (SPO2) were recorded for each patient immediately before aerosol administration     (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the     presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of     extubation.   "
114558|NCT01786356|"     Age-related cataract is the main cause of impaired vision in the elderly population     worldwide.      The only treatment that can restore functional visual ability is cataract surgery where the     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular     lens is implanted into the remaining capsular bag. Cataract operations are generally very     successful, with a low risk of serious complications.      The most common reason for impaired vision after uneventful cataract surgery in otherwise     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a     physiological change (thickening, opacification and clouding) of the capsular bag expected     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that     uses a laser to open a central hole in the posterior capsular bag.      Modifications in IOL design and material lead to a decrease in the incidence of PCO.      During the past two decades, refinements in surgical technique were made resulting in today's     small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are     available, many of them similar but of course with some differences in regard to the chemical     composition of the acrylic material and the IOL design.      The purpose of this study is to compare the development of posterior capsule opacification     (PCO) and the frequency of treatment between two different microincision IOLs over a period     of 4 years.   "
114559|NCT01786343|"     The goal of this clinical research study is to compare how well 2 different dosing schedules     of decitabine may help control AML.      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause     cancer cells to die.   "
114560|NCT01786330|"     This is a pilot study investigating the use of abdominal binders after cesarean sections. The     researchers are testing whether elastic abdominal binders improve postoperative pain control     and reduce postoperative blood loss. Blood loss and pain control are both concerns after     giving birth. It is hoped that the use of an abdominal binder after giving birth will provide     a non-pharmacologic way to to reduce blood loss and manage pain.   "
114561|NCT01786317|"     Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3     pressure sensors. The investigators aim to evaluate the usefulness of high resolution     manometry to measure anorectal motility   "
114562|NCT01786304|"     Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence,     although its mecanims of action remains poorly understood. The investigators hypothtized that     SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators     will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces     changes in ENS.   "
114563|NCT01786291|"     Positive airway pressure (PAP) therapy is generally offered to patients with obstructive     sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by     preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators     sought to verify this by assessing cardiac and pulmonary function during exercise.   "
114564|NCT01786278|"     The objective of the study is comparison of the efficacy and safety of palliative therapy     with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia     resulting from adenocarcinoma of the esophago-gastric junction.   "
114565|NCT01786265|"     The goal of this clinical research study is to learn if treatment with hormone therapy in     combination with abiraterone acetate and prednisone for 8 months controls the disease better     than treatment with standard hormone therapy alone.      Abiraterone acetate is designed to decrease the production of testosterone (male sex     hormones), which plays a role in causing prostate cancer to grow.      Prednisone is commonly used to treat prostate cancer and is given along with abiraterone     acetate treatment to help lower or prevent some side effects.   "
114566|NCT01786252|"     Worldwide, 1 in 12 couples experience difficulty in getting pregnant and seek the help of     assisted reproductive technologies (ART) such as in vitro fertilization (IVF-egg is     fertilized by sperm outside the body), ovarian stimulation (medications are used to stimulate     egg development) and intra-cytoplasmic injection (ICSI-single sperm is injected directly into     the egg).      Regardless of the ART procedure being performed, the newly fertilized embryo must still     implant into the mothers endometrium (inner lining of uterus). This implantation process in     humans is surprisingly inefficient and accounts for up to 50% of ART failures. Intrauterine     infusion of hCG prior to embryo transfer has recently been shown to increase pregnancy rates     but the cellular mechanism for this increase is unknown.      Successful implantation requires the newly fertilized embryo and the endometrium develop in a     synchronized manner. This coordinated development is accomplished, in part, by proteins     secreted by the embryo which circulate throughout the maternal bloodstream and alert the     maternal body organs (i.e. ovary, endometrium, breast, ect) that fertilization has occurred.      One of the earliest of these secreted proteins is human chorionic gonadotropin (hCG), which     is the molecule detected in over-the-counter pregnancy tests. From previous studies, we know     that hCG production by the embryo alerts the ovary to continue producing progesterone, a     hormone required for pregnancy. However, very little is known about the direct effect of hCG     on the endometrium during early pregnancy in humans.      Using animal models, hCG has been shown to induce specific changes in the endometrium,     suggesting that embryo-derived hCG may be priming the endometrium in anticipation of     implantation. The goal of this research study is to examine the direct effect of hCG on the     human endometrium and see if this priming effect is also present in humans. Findings from     this research may reveal whether pre-treatment with hCG can enhance ART outcomes, especially     pregnancy rates.   "
114567|NCT01786239|"     This 16-week placebo-control study looks to investigate whether patients with schizophrenia     for two years or less may benefit from omega-3 supplements.   "
114568|NCT01786226|"     Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and     mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months     follow-up period.      The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in     fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.   "
114569|NCT01786213|"     Colon cancer is the second most common cause of death among cancer-related deaths in Germany.     Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide     high quality in colonoscopy several quality parameters have been postulated in the past. The     adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a     detection rate of 20% should be demanded. Detection rates are influenced by a multitude of     circumstances such as bowel cleanness. The facts that detection rates vary between     colonoscopists suggests that leaning effects may also play a role. It is not known how ADR     and other quality parameters evolve while trainees improve their skills in colonoscopy. The     investigators postulate that a learning curve exists. The investigators therefore plan to     evaluate chronologically the findings of trainee colonoscopists. A particular performance in     detecting adenomas shall be calculated in relation to the amount of examinations performed.   "
114571|NCT01786187|"     Little is known about the symptom experience of persons having undergone surgery for lung     cancer. What we do know is that symptoms are common and can become severe and lasting. The     main purpose of this study is two-fold:        1. To better understand the symptom experience of persons with lung cancer prior to surgery          and for up to six weeks after returning home from the hospital.        2. To examine the role of a light physical activity program in persons who are undergoing          surgery for lung cancer for the treatment of a specific symptom.      The goals of this study include:        -  Collecting information about the participant's current and prior health history,          symptoms, and health-related quality of life.        -  Assessing our ability to recruit participants to the study.        -  Assessing participant's level of participation.        -  Evaluating the participant's satisfaction with the program.      We expect that patients after undergoing surgery for lung cancer during the recovery process     will experience multiple symptoms. We also expect to find that a light intensity physical     activity program will be feasible, acceptable, and show a positive impact on symptoms such as     cancer-related fatigue and confidence for cancer-related fatigue self-management.      Information gained from this randomized controlled trial study will be used to refine the     design of future larger-scale studies targeting symptoms such as cancer-related fatigue for     the lung cancer population.   "
114572|NCT01786174|"     The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe     and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).   "
114573|NCT01786161|"     Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected     methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to     optimize the dosing of vancomycin for this critically ill population. The most efficacious     method of administering vancomycin is debated in the literature. Since vancomycin is     associated with slow bactericidal activity, it is important to closely monitor serum     concentrations so as to achieve early target serum concentration, particularly when treating     aggressive S. aureus infections. One study has shown that vancomycin infused continuously may     enable faster and more consistent achievement of a therapeutic serum concentration when     compared to intermittent infusion. A faster achievement in the goal serum vancomycin     concentration would be a protective factor for intensive care unit mortality in patients with     MRSA infection.      Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a     vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this     nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve     target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram     with a continuous infusion. The aim is to determine which of the two dosing nomogram is more     efficient and safer for SICU patients.   "
114574|NCT01786148|"     The overall goal of this project is to use technology to improve adherence to antiretroviral     therapy (ART)and increase access to ART adherence care for those HIV+ persons living in rural     areas. The LIVE Network audio music program mobile application (app) is innovative,     practical, portable, and could be rapidly scaled up to address the adherence self-management     needs of rural groups nationwide. If successful, the impact on HIV care will be immense and     could transform the delivery of HIV self-management and adherence education by overcoming     barriers of geographic isolation, transportation, stigma and confidentiality in this     vulnerable group.   "
114575|NCT01786135|"     This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and     tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin     lymphoma (B-NHL)   "
114576|NCT01786122|"     AIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for     patients during treatment for gastrointestinal tumors, breast and non small cells lung     cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect     the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two     parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in     coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors,     locally advanced or with metastatic disease, in adjuvant treatment, with Performance     Status(PS) PS1-PS0. INTERVENTION: Both groups received standardized usual care. The EP group     will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a     second phase in community facilities during the remaining 10 months. MEASUREMENTS: The     primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by     the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36)     overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes     walking and cardiopulmonary test), muscle strength and progression-free survival and overall.     Predictors and confounders: age, sex, stage and tumor type, histology, treatment. ANALYSIS:     We will compare between groups mean changes from baseline measurement of quality of life     questionnaire (QOL) and other variables, on an intention to treat basis, using longitudinal     mixed-effects models for repeated measures at 2, 6 and 12 months follow-up. Cost /     effectiveness and cost / incremental utility associated to the program wil be estimated.   "
114577|NCT01786109|"     Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no     effective and safe medications approved for the treatment of abdominal pain associated with     bowel symptoms in IBS. This study will investigate the effects of an approved medication,     Dronabinol, on the movement of food through the stomach and colon in subjects with a history     of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).   "
114578|NCT01786096|"     This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and     tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory     B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage     lymphoblastic lymphoma (B-LBL).   "
114579|NCT01786083|"     The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique     (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically     ill patients.      And also to describe and evaluate the process carried out by nurses when implementing the PST     as a useful tool for care for family caregivers.   "
114581|NCT01786057|"     Plantar fasciitis is one of the most common causes of heel pain. This study will be performed     in the purpose of determination the effects of extracorporeal shock wave therapy of     gastrosoleus trigger points in patients with plantar fasciitis   "
114585|NCT01786005|"     Spasticity - movement disorder, which is part of the syndrome of defeat top motor-neuron,     characterized by the rate-dependent increase in muscle tone and increased dry-core     reflections from hyperexcitability of stretch receptors (Lance, 1980). Spasticity - a     frequent symptom of neurological diseases (Valero-Cabre, Pascual-Leone, 2005) and may be     accompanied by such a disorders consequences of stroke, multiple sclerosis, head trauma and     spinal cord, cerebral palsy, etc. The magnitude and severity of spasticity depends on the     level of the lesion, the duration of its existence from the time before the disease, and     possible plastic changes in axons and synapses on the affected level. There are two basic     models of spasticity: cerebral (hemiplegic) and spinal (paraplegicheskaya) (Nikitin, 2005).     Cerebral model appears with the direct injury of the brain and is characterized by increased     excitability of monosynaptic reflexes with the rapid development of pathological ref-plexes     and characteristic hemiplegic posture. Model is characterized by spinal spasticity opposite     lower segmental inhibition polysynaptic reflexes slow increase of nervous excitability due to     the mechanism of cumulative excitation perevozbuzhdeniem flexor and razgibate-ing, as well as     expansion of the area of segmental responses (Nikitin, 2005). As spinal and cerebral     spasticity are extremely difficult corrected by standard medical clinic and physiotherapy     methods. In this regard, in the world literature actively searched for addi-tional search     correct this symptom. A new modern methods that could affect the syndrome of spasticity is     rhythmic transcranial magnetic stimulation (Mori et al., 2009).   "
114586|NCT01785992|"     70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to     grow and are likely to respond to hormone treatment. This type of treatment reduces the     amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One     type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from making     oestrogen. Currently, women with locally advanced or metastatic breast cancer that is not     being controlled by one class of AI are switched to the other class of AI. The reason for     this is that some cancer cells can become resistant to one class but are still sensitive to     the other class. However, oestrogen can be made in the body by two pathways and AIs block     only one of these pathways. A new drug called Irosustat can reduce the production of     oestrogen in the body by blocking the second pathway. This study is investigating whether     adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further     reduce the amount of oestrogen in the body and therefore control the breast cancer better.      27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic     breast cancer that is not being controlled by their current AI treatment will be recruited in     this study from 9 United Kingdom (UK) hospitals. Eligible patients will receive 40mg of     Irosustat once daily in addition to the AI on which they progressed. Patients will receive     Irosustat for as long as it controls their cancer or until they have side effects that stop     them from taking treatment. Patients will be seen monthly for the first 6 months and every 3     months thereafter. Participating patients will also be given the option to take part in the     exploratory part of this study by donating tissue and blood samples.   "
114587|NCT01785979|"     This randomized clinical trial will address a complication related to recurrent episodes of     malaria in endemic areas - hyper-reactive malarial splenomegaly. We aim to assess the     efficacy of chloroquine after prednisone-induction therapy compared to standard treatment of     chloroquine alone in the treatment of adult patients with newly diagnosed hyper-reactive     malarial splenomegaly.   "
114588|NCT01785966|"     CHECKLIST-ICU will be a cluster randomized trial to ascertain whether the use of an     intervention including 1) checklists with assessment of daily goals during the     multidisciplinary visit, and 2) clinician prompting can reduce in-hospital mortality of     patients admitted to intensive care units (ICUs).      The investigators also aim to describe participant ICUs in terms of the standards for     intensive care units proposed by the Brazilian National Health Agency (ANVISA).   "
114589|NCT01785953|"     The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years),     treated with conventional and experimental chemotherapy following allogeneic transplantation.     THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette     University Hospital. The purpose of data collection is to assess, with retrospective     analysis, the clinical outcome divided by risk class and evaluated in patients who achieve     complete remission after induction therapy and consolidation.   "
114590|NCT01785940|"     Total shoulder surgeries are associated with considerable postoperative pain which may     prevent rehabilitation and early discharge from the hospital. Continuous interscalene blocks     with home infusions are commonly performed for pain relief following total shoulder     arthroplasties. We want to evaluate the time to readiness for discharge following     interscalene blocks in patients undergoing total shoulder arthroplasties.   "
114591|NCT01785927|"     The inhaled route of delivery has always been associated with the considerable challenge of     getting the drug to its target. The lungs are a highly complex organ designed to filter     inspired air, with many different cell types contributing to their function. Furthermore, the     lungs may change dramatically when afflicted by disease resulting in an internal environment     that works against the drug reaching and interacting successfully with the target. For     targets in the upper airways this will have lesser significance, but drug delivery to the     deep lung may be impeded by changes such as mucus hyper-secretion or thickening or airway     narrowing.      In order to interpret toxicology findings it is necessary to reconcile test sensitivity,     background biological variation, normal responses to inhaled materials and drug or     medicine-specific adverse effects. Identification of adverse end-points is an area where     better control data sets might help discern true adverse effects from a normal physiological     lung response. The lung responds acutely to inhalation of irritant materials by     hyper-secretion of mucus, chemokine release, inflammatory cell recruitment and cough and     collectively these may be characterized as non-specific irritancy.   "
114636|NCT01785342|"     The goal is to improve the efficiency of the diagnostic follow-up of patients with     indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis     that are measured in minimally invasive biospecimens are able to distinguish malignant from     benign pulmonary nodules that are incidentally detected in high-risk smokers.   "
115211|NCT01777828|"     Register multicenter, prospective, open, non-randomized implantation of percutaneous aortic     bioprostheses through for the treatment of severe degenerative aortic stenosis     Epidemiological data and the 1-year survival of aortic bioprostheses implanted by     percutaneous.   "
114594|NCT01785888|"     This is a non-interventional diagnostic, international, multicenter and non-comparative study     of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with     adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and     Europe and will assess the concordance of EGFR mutation status derived from tumour samples     and blood based circulating free DNA. The data generated will inform the use of less-invasive     sample types in diagnostic practice. The study also aims to assess the current status of EGFR     mutation testing across Japan and Europe and gaps in currently available data including EGFR     mutation frequency in particular populations and demographic subgroups, EGFR mutation     frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology,     utility of multiple sample types in the assessment of EGFR mutation status, and impact of     EGFR mutation status on therapy choice. The data may be used to drive improvements to the     EGFR mutation testing process, ensuring that patients have access to testing and are treated     appropriately on the basis of the molecular features of their disease.   "
114595|NCT01785875|"     This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG     416) for the treatment of SHPT in adults with CKD on hemodialysis.   "
114596|NCT01785862|"     The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low     dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute     sore throat pain.   "
114597|NCT01785849|"     This study is designed to assess the efficacy and safety of etelcalcetide compared with     placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving     hemodialysis.   "
114598|NCT01785836|"     This study will assess the safety, tolerability, and efficacy of dapsone in subjects with     acne vulgaris following 12 weeks of treatment.   "
114599|NCT01785823|"     We investigated the efficacy and the safety of the pharmacokinetic model-based     patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after     total intravenous anesthesia (TIVA).   "
114600|NCT01785810|"     RATIONALE: Successful allogeneic stem-cell transplantation is often limited by     graft-versus-host disease (GVHD). Migration of donor cells into tissues plays a major role in     GVHD. Drugs that block chemokine receptors such as CCR5, can potentially decrease the     migration of donor cells into tissues. Blocking CCR5 after allogeneic stem-cell     transplantation may therefore reduce the rates of GVHD.      PURPOSE: This study explores the efficacy of pharmacologic inhibition of CCR5 in prevention     of GVHDby administering maraviroc during allogeneic stem-cell transplantation with reduced     intensity conditioning.   "
114601|NCT01785797|"     This is a prospective randomised-controlled multi-centre trial based in Hong Kong to     determine whether temporary subdural drain placement after burr hole evacuation of a chronic     subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or     above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole     operative drainage will be randomly allocated into one of two groups: (1) for intra-operative     subdural drain placement (intervention group) or (2) not for drain placement (control group).     Using web-based software block randomisation with an allocation ratio of 1:1 will be     conducted. Instructions to use or not to use a drain will be contained in a sealed envelopes     labelled with sequential study numbers.      Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the     haematoma the patient's condition is unsafe for drain placement, the subject will be excluded     from the study. Otherwise, randomisation will be performed at this juncture by the opening of     the sealed envelop. The procedure involves placing a prefabricated silicon drain into the     subdural space according to a standard protocol and will be removed on the second     post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain     placement is unsafe will be excluded from the study. Drainage is undertaken passively by     hanging the collection bag at the bedside in a dependent position. In addition to general     demographic, clinical and radiological presentation data, potential risk factors for     recurrence will be documented. Serial computed tomography brain scans will be arranged     (before discharge, at four weeks and six months) and the occurence of significant subdural     haematoma recurrence requiring repeat operative drainage at six months will be recorded.     Other outcome measures to be determined at regular time intervals for a total follow-up     period of six months (upon discharge, at four weeks and six months) include: functional     performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added     neurological deficit, death and other surgery-related complications. All outcomes will be     documented by the trial investigators or by the responsible clinician. The data obtained will     be analysed according to the principle of intention to treat.      Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control),     the additional placement of a subdural drain after evacuation (intervention) will reduce the     risk of recurrence requiring repeat surgery.   "
114602|NCT01785784|"     This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and     safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for     Topical Application (rhGM-CSF Gel) on deep 2nd burn.      There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized,     reference controlled study, all the subjects were randomized into two groups, test group     (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were     enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were     enrolled in reference control group. In the test group, after the patients were enrolled in     the group, clean the wound surface regularly and wash with normal saline, spread the test     drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product     every two or one day according to the effusion. In the reference control group, after the     patients were enrolled in the group, clean the wound surface regularly and wash with normal     saline, bandaging with iodophor gauze, change the drug product every two or one day according     to the effusion. Whole treatment were lasted till the wound surface was healing completely,     if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part     of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd     burn patients. Totally 2329 patients were enrolled in this part of the study.   "
114603|NCT01785771|"     An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients     with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed     by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment     with ITCA 650 60 mcg/day   "
114604|NCT01785758|"     The purpose of this study is to determine whether sugammadex reverses a profound     neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as     effectively and safely as it does in patients with normal renal function.   "
114637|NCT01785329|"     Primary Objective:      To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553     (REGN727) administered at 3 different injection sites in healthy subjects.      Secondary Objectives:        -  To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab          SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and          apolipoproteins.        -  To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727).        -  To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553          (REGN727).   "
114605|NCT01785745|"     It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of     neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in     comparison with traditional therapeutic exercise. The traditional exercise protocol contains     mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and     exercises against elastic band resistance. The neurocognitive exercise protocol contains ten     exercises involving specific instruments (e.g., table inclined with a board with five     concentric circles, sponges of various texture). Each subject, randomly assigned to either     neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2),     will be submitted to one-hour session for three times a week for five weeks. The outcome     measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome     score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at     baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from     the end of treatment.   "
114606|NCT01785732|"     Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based     renal denervation causes substantial and sustained blood- pressure reduction in patients with     resistant hypertension.      The purpose of RENSYMPIS is to study the effects of renal denervation on:        1. Cardiovascular function        2. Metabolic factors        3. Inflammatory and endocrine factors        4. Coagulation        5. Sleep   "
114607|NCT01785719|"     The purpose of this study is to investigate the effects of weight loss on ovarian morphology,     metabolism, and body composition in overweight and obese women with polycystic ovary syndrome     (PCOS).   "
114608|NCT01785706|"     The COPD Research Registry is a confidential database of individuals diagnosed with COPD or     at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with     the purpose of providing a mechanism for researchers to boost enrollment in clinical trials     and other research studies. The COPD Foundation is working with National Jewish Health in     Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest     confidentiality of participant information.   "
114609|NCT01785693|"     The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the     benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and     clonidine in a single dose, performed before induction of general anaesthesia, on analgesia     postoperatively assessed by morphine consumption.      Applied to the patient at the beginning of general anesthesia, this technique could allow one     hand, to reduce the need for opiates, on the other hand - due to anesthetized limb     vasodilation - to improve tissue perfusion downstream.   "
114610|NCT01785680|"     The long-term objective of this proposal is to develop and demonstrate an effective,     integrated and streamlined protocol to treat moderate acute malnutrition (MAM) and     non-complicated severe acute malnutrition (SAM) in children during humanitarian emergencies.      Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community     coverage and a greater individual recovery rate than standard care.   "
114611|NCT01785667|"     The objective of this study is to clarify the current diabetic status, including development     of complications, in a nationwide cohort of type 1 diabetics, who were last examined together     in a large study in 1995. These youngsters were originally participating in a nationwide     study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to     establish risk factors for developing diabetic retinopathy. The investigators will have     emphasis on retinal vessel geometry and the possibilities for early detection of reversible     retinal changes, and prediction of other vascular complications.   "
114612|NCT01785654|"     Prospective, observational clinical multicentric study in ICU; during the period surrounding     the orotracheal intubation.   "
114613|NCT01785641|"     To compare the efficacy of single versus combined antibiotic therapy for bacterial     peritonitis in CAPD patients.   "
114614|NCT01785628|"     The project will investigate the effect of pharmacological and electric modulation of     N-methyl-D-aspartate (NMDA) pathway on the cognitive flexibility and volitional movement     preparation in patients with Parkinson's disease (PD).   "
114615|NCT01785615|"     Little is known regarding the association of individual components of the metabolic syndrome     (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional     markers in women with this syndrome. Less is known about adequate treatment as the     pathological mechanism of this syndrome is not well understood.      The purpose of this study is two fold;        1. To determine basic differences in biochemical and cardiovascular structural markers in          women with and those without MBS and their association with the individual components of          MBS.        2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome.          Atorvastatin is one of the most effective drugs approved by the United States Food and          Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class          of drugs called statins and its role in primary prevention is still unclear. Thus this          population seems to be an ideal group that may benefit from this intervention.   "
114616|NCT01785602|"     The purpose of this study is to determine whether QAW039 is safe and has beneficial effects     in people who have moderate to severe atopic dermatitis (AD).   "
114617|NCT01785589|"     The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear     medicine. The increased photon counting sensitivity of camera can be used to explore novel     protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed     SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines     the use of thallium-201 with technetium-99m agents permitting optimal image resolution and     simultaneous assessment of viability, all with an exam duration of approximately 20 minutes.     However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope     high-speed myocardial perfusion imaging versus invasive coronary angiography. The     investigators report here the first validation of high-speed protocol with dual isotope for     myocardial perfusion imaging using invasive coronary angiography as the standard of     reference.   "
114618|NCT01785576|"     The purpose of this study is to determine whether a brief couple-based supportive     intervention effectively assists patients and their partners coping with the challenges of     head and neck cancer.   "
124482|NCT01656356|"     The purpose of this study is to evaluate safety and reactogenicity of live attenuated     influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,     in Thailand to previously healthy Thais.   "
114619|NCT01785563|"     The purpose of this study is to determine if a new type of mechanical ventilation, or     breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide     additional support to infants who were born prematurely. Investigators are looking to     determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will     demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved     in their blood as compared to prior to starting the study. This will be accomplished by     enrolling infants who are stable on their current type of mechanical breathing that provides     a constant air flow into the infant. This type of mechanical support helps keep the lungs     inflated but does not help remove carbon dioxide. This study will change the type of     mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA.     This type of mechanical support detects when the infant is breathing in by having electrical     sensors on a feeding tube that is placed into the stomach through the nose or mouth. These     electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying     to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides     additional air flow to make the effort of breathing easier. The ventilator will be attached     to a tube or cannula that is placed into the infant's nose. After two hours of being on the     NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a     small amount of blood from the infant's heel.   "
114620|NCT01785550|"     Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease     affecting motor neurons. Early diagnosis is essential for the success of clinical trials and     objective biomarkers are needed for monitoring disease progression. Nerve and muscle     ultrasound may provide this information.      This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to     identify and monitor disease progression in ALS.   "
114621|NCT01785537|"     The main aim of this multicentric 5-year follow-up study is to evaluate for the first time     the long-term efficacy and safety (in terms of smoking-related serious diseases requiring     hospitalization) of e-cigarette smoking, comparing its health effects with those of     traditional cigarette smoking and mixed electronic and traditional cigarette smoking.      The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of     life, and the reported adverse events according to current and past smoking habit.      Finally, the study will also explore the long-term adherence to e-cigarette smoking and its     efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.   "
114622|NCT01785524|"     The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and     peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption of     a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of     supervised exercise training at the limb ischemic threshold (SET) will produce a greater     clinical benefit (increases in claudication onset time [COT] and peak walking time [PWT]     relative to a group with the same exercise training but supplemented with placebo .This study     is essentially exploratory in nature and designed to provide us with information to     adequately develop power and execute a larger study. We have previously seen benefits from     nitrate supplementation on function in PAD.   "
114623|NCT01785511|"     Endothelium derived nitric oxide (NO) regulates vascular tone and blood pressure in man. NO     also inhibits platelet aggregation and mediates a variety of beneficial anti-inflammatory and     repair mechanisms. NO may also be a mediator in the release of the endogenous fibrinolytic     factor, tissue-plasminogen activating factor (t-PA) from the endothelium.1 Via these actions     it plays a very important role in protection of the vasculature from atherothrombosis and     clinical sequelae such as myocardial infarction and stroke.      Visible and ultraviolet (UV) light relax vascular smooth muscles by producing NO in a     phenomenon known as photorelaxation.2 The investigators have demonstrated significant stores     of pre-formed, bound NO and other nitrosospecies in human skin, which are rapidly released     upon exposure to UVA.3 The investigators have demonstrated recently that serum nitrite and     nitroso-species are increased after standing in a UVA phototherapy cabinet and that local UVA     exposure is associated with increased forearm arterial blood flow that is independent of skin     temperature. The investigators have also demonstrated a fall in mean arterial blood pressure     in subjects exposed UVA.      Cardiovascular morbidity and the prevalence of hypertension vary with latitude. The     investigators hypothesise that some of this geographical variation may be explained by a     diminished sunlight/UVA exposure with attendant negative effects upon NO bio-availability.4     To further examine the potential beneficial effects of UVA exposure we will examine the     effects of whole-body UVA upon platelet activation and upon myocardial/coronary arterial flow     reserve. The investigators will correlate these measures with systemic nitrate, nitrite and     nitroso-species content in healthy volunteers.      HYPOTHESES        1. UVA irradiation enhances coronary flow reserve in healthy volunteers.        2. UVA irradiation suppresses platelet activation in healthy volunteers.        3. UVA irradiation enhances the release of endogenous fibrinolytic factors in healthy          volunteers.   "
114624|NCT01785498|"     Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource     development project. The goal of the project is to develop an implementation plan that would     enable children with complex heart problems to lead healthy, active lives within their own     community. The primary goal of the project is to promote physical activity, because the     physical and mental health benefits of activity are very important for these children.     Children with complex heart problems have a higher risk for obesity, diabetes, acquired heart     disease and mental health problems than their healthy peers. The physical health benefits of     physical activity are well known, but physical activity is also key for children's mental     health. Physical activity enables children to socialize with peers and create bonds and     friendships. Physical activity participation also directly elevates mood through the release     of brain chemicals. Children with complex heart problems are also known to experience fear     and anxiety related to physical activity. This project will also develop strategies to     promote healthy eating and the prevention of physical activity-related injuries to these     children and their families. Children with complex heart problems are at higher risk of     overweight and obesity and face unique injury risks related to pacemakers or their     medications.      Extensive consultations with families and caregivers have identified needed supports for     physical activity lifestyles, mental health, healthy eating and injury prevention for these     children. The goal of the interviews was to understand the positive and negative influences     on physical activity and healthy lifestyles for these children. Analyses of the interview     content was used to develop a detailed, step-by-step implementation plan to provide the     supports necessary for children with complex heart problems to lead active, healthy lives in     their own community, with their family and friends. The implementation plan specifies changes     to family education and counselling resources, clinical care routines, and communication     among professionals and families.      The clinical trial will evaluate the impact of implementing the family supports and changes     to practice previously developed. Surveys will be completed by families attending the cardiac     clinic before and after the changes to practice and additional resources are made available.     Interviews will be utilized to gather additional feedback from professionals and families     that receive counselling utilizing the supplementary materials.   "
114638|NCT01785316|"     A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic     Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in     patients with isolated liver metastases from uveal melanoma.   "
114639|NCT01785303|"     The overall goal of this project is to determine the efficacy of a multidisciplinary     treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia.      Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive Behavioral     Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with OSA and     comorbid insomnia.      Specific Aim 2: To determine if there are relative benefits in the sequence of treatment     initiation.      Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.   "
114625|NCT01785485|"     This study is Phase II of a project by the University of Arizona Center for Integrative     Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics     (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the     clinical and cost effectiveness (outcomes) of an integrative medicine professional practice     model for adult primary care delivery (the University of Arizona Integrative Health Center -     UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC.     In addition, a fidelity evaluation will assess whether the practice model was implemented as     planned.      The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and     staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient data     from medical records abstractions, self-report assessments, clinic administrative and service     utilization/encounter data, and health insurance claims data; and, 3) Conduct fidelity     evaluation of the implementation of the UAIHC model as described in its business plan using     patient- and staff-reported fidelity assessments, random chart audits, and abstracted clinic     administrative data.      Participants. 1) Participants from the clinic patient population for whom clinical and cost     outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be     collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected     (n=14).      Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic     visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and     biomarkers from medical records abstractions; patient reported outcomes and satisfaction     questionnaires; clinic service encounter logs; and, cost data from health insurance claims     information and clinic financial data. For fidelity evaluation, data will be collected     monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually     from then on. Patient data for fidelity will be gathered on a single randomized day of the     week using a self-administered patient feedback questionnaire. For personnel, fidelity data     will be collected at the same intervals using a self-administered provider perceptions     questionnaire of inter-professional team and integrative medical care. Data from audits of     randomly selected patient charts and administrative records will also be used.   "
114626|NCT01785472|"     This study will assess the efficacy and safety of multiple doses of LCZ696 compared to     olmesartan in Asian patients with essential hypertension   "
114627|NCT01785459|"     Headache is a common chief complaint of patients presenting to the emergency department (ED),     accounting for approximately 3 million ED visits per year. Headache treatment is often a     source of frustration for both patients and providers. By the time patients with benign     headaches arrive in the emergency department, they have often failed non-invasive therapeutic     attempts and providers are often left with few therapeutic options. Treatment of benign     headache varies between providers, often including systemic medications with a multitude of     possible side effects. In recent years, there has been preliminary investigation into     anesthetic injections for the undifferentiated headache patient presenting to the emergency     department. It has been proposed that these patients presenting with benign headache might     benefit from this novel treatment.      Patients that present to the Emergency Department with a diagnosis of benign or primary     headache with serious or life-threatening causes of headache will be offered enrollment into     the study.      Following consent, subjects will receive either 0.5% bupivacaine injected bilaterally in the     paraspinal musculature of the cervical spine or the standard treatment with intravenous     Prochlorperazine. The subjects will complete a validated pain scale before, and 20 minutes     after injection. At twenty minutes post-injection, the subject will be reevaluated for     symptoms. The subject will then be eligible for discharge or standard treatment at the     discretion of the treating physician.      Subjects will be followed for 72 hours after enrollment for headache recurrence. Subjects     will be monitored for immediate and post-discharge complications.   "
114628|NCT01785446|"     The purpose of this study is to:        -  determine the effect of dexmedetomidine on cisatracurium infusion requirements and          sufentanil consumption.        -  analyze the cisatracurium infusion requirements and sufentanil consumption in different          age groups.   "
114629|NCT01785433|"     The primary objective of this study is to assess and compare the pharmacokinetics (PK) of     Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day),     SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day)     following repeat dosing for 7 days in subjects with COPD.   "
114630|NCT01785420|"     Background Information and Rationale:      Trastuzumab is a humanized monoclonal antibody that acts extracellularly on the erbB-2     receptor.Trastuzumab is a recombinant humanized IgG1 monoclonal antibody against the human     epidermal growth factor receptor 2 (HER2/erbB-2),which has shown in both in vitro assays and     in animals, to inhibit the proliferation of human tumour cells that overexpress erbB-2.     Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated     cytotoxicity (ADCC). In vitro, trastuzumab-mediated ADCC has been shown to be preferentially     exerted on erbB-2 overexpressing cancer cells compared with cancer cells that do not     overexpress erbB-2. Trastuzumab has emerged as a widely accepted standard of care for     erbB-2-positive disease. (Metastatic/ adjuvant/neoadjuvant.      Our current hypothesis suggests that the cells which are disseminated at the time of surgery     will encounter an inhospitable environment which will be anti-HER in nature. Therefore     combining the above mentioned streams of thought, we would like to assess the effect of a     short pre-operative course of Trastuzumab on breast cancer relapse. The study is proposed in     HER2 positive patients with operable breast cancer.      Objectives :      Primary:      The primary objective of the study is to see the effect of short duration of peri-operative     Trastuzumab on disease-free survival in comparison in all patients      Secondary:      The safety of the pre-operative therapies including the early post operative morbidity        1. Overall survival (OS) in all patients and in pathologically node positive patients.        2. The level of circulating tumor cells (CTCs) in the peripheral blood assessed before          starting pre-operative therapy and at the same time point in the control arm, level of          CTCs 10 minutes prior to start of surgery, during surgery and 10 days after surgery on          40 consecutive consenting patients (20 in each arm). The levels of circulating chromatin          will also be estimated at the same time points as CTC for these 40 patients.        3. Evaluation of the paraffin blocks for pTEN loss6-8 and p95ErbB2 truncated form of HER2          on 100 consecutive consenting patients (50 in each arm).9-11      Study Design :      This is phase 3, randomized Double blinded parallel group study of Trastuzumab in pre     operative setting in operable breast cancer patients.      Approximately 1000 patients with Women with HER2neu positive, T1/T2/T3 and N0/N1. clinical T4     and/or N2 disease who are considered operable by the treating surgeon with histopathological     diagnosis on core biopsies, will be included in the study. Patients with T4 or N2 (locally     advanced and large operable for neo-adjuvant chemotherapy) will not be included. All node     positive patients will receive single injection of Depot Inj. Progesterone 500 mg deep IM 4     -14 days prior to surgery      Patients will be stratified, before randomization for Tumor size, menopausal status, and     affordability for Trastuzumab and centre of the study. These patients will then be randomized     1:1 to receive the following      Intervention arm: .A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as a     90 minute intravenous infusion in 250 ml of normal saline, in the window period of 10-15 4 to     14 days (both days inclusive) prior to the planned date of surgery.      Control arm: A 90 minute intravenous infusion of saline as placebo      All patients will thereafter receive standard post-operative adjuvant therapy as per local     institutional practice including hormonal therapy, chemotherapy and radiation therapy.   "
114631|NCT01785407|"     Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia.     However, absorption of OIS is often low and response is variable. To overcome this, large     doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses     should be low, while maximizing absorption. The prevailing serum hepcidin concentration     (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on     limited data in humans, SHep can be increased by a single OIS dose but the duration of the     increase is uncertain: it may be in the range of 24 to 96 hr. Also, there are few data on how     the increase in SHep determines the absorption of further doses of oral iron. Is there a     threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding     of this relationship would be valuable to design more effective and safer OIS regimens.      Objectives: 1) Determine the duration and magnitude of the Fe induced Hepcidin rise form a     single iron dose while determining its bioavailability and 2) Compare the bioavailability of     a single dose to iron supplements consumed one after the other (two dosages).   "
114632|NCT01785394|"     The purpose of this study is to determine whether exhaled breath temperature, a surrogate     marker of airway inflammation, rises during the pollen season in sensitized subjects with     allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with     respective allergens suppresses the seasonal increase of EBT. During the second year (2013)     of the trial all patients will be treated with 5 grass allergen extract: carry over     differences between the active and placebo arms from the previous year (2012) will be looked     for.   "
114633|NCT01785381|"     Introduction: Hip fracture due to osteoporosis is associated with an extremely high mortality     morbidity and loss of quality of life. The risk of future fracture after a first hip fracture     is increased. Several studies reported that patients who suffered from a fracture are not     optimally treated and do not receive osteoporosis treatment after the first fracture episode.      Aim: To evaluate whether a coordinator increases the optimal management of osteoporotic     fracture patients and hip fracture patients.   "
114634|NCT01785368|"     The main objective of this study is to evaluate the impact of the implementation of referral     guidelines for imaging exams requested by the emergency department on exam relevance. The     latter is assessed via the rate of suspected diagnoses that are confirmed by the requested     exam.   "
114635|NCT01785355|"     Several studies revealed a direct relationship between the severity of periodontal     inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other     source of inflammation but PDD, proper dental treatment of the disease decreased CRP to     normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007)     Moreover, a direct link between high levels of CRP and atherosclerotic complications has been     found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et     al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann     J, et al. 1998).   "
114641|NCT01785277|"     The propose of the study is to validate in Mexico a spanish translation of the Spinal Cord     Independence Measure (SCIM) Version III, in patients with spinal cord injury (SCI).      Internal consistency, reproducibility and reliability will be addressed scoring the results     of the translated version at two time frames and also of the same patients by different     examiners (physicians, nurses and technicians).   "
114642|NCT01785264|"     To compare the end-results of three different methods of treatment of acute achilles tendon     ruptures, it is necessary to establish identical rehabilitation protocols. Traditionally,     early mobilization has been reserved for patients treated surgically and this may have     unintentionally skewed treatment results. The investigators have therefore designed a     prospective randomized trial performed as collaboration between Akershus University Hospital     (Ahus), Oslo University Hospital (The Emergency Department), Østfold Hospital (Fredrikstad)     and Drammen Hospital. The four institutions were chosen because of their geographical     proximity and because they jointly have a substantial catchment area. Treatment is divided     into three arms, and patients between 18 and 60 years of age sustaining first time achilles     tendon ruptures will be invited to participate.   "
114643|NCT01785251|"     Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein     Thrombosis (DVT) during the recovery period following surgery despite the availability of     effective pharmacological and mechanical prophylactic methods. The use of calf muscle     neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this     patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and     comfort characteristics of NMES in post-THA patients immediately following surgery have yet     to be established.      The main objectives are:        1. To establish if patients in the early post-operative period have tolerance for NMES.        2. To determine if applying NMES to patients immediately post-THA increases venous outflow          from the lower limb over resting conditions.   "
114644|NCT01785238|"     The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who     have presented neonatal acute renal failure. The investigators hypothesize that signs of     nephronic reduction would appear earlier in former preterm with neonatal acute renal failure     than in control preterm infants.   "
114645|NCT01785225|"     Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are     performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement     or blood donation. The predominantly used venous for blood withdraw are in the cubital region     because in this area venous are most superficial placed and most often visible for the human     eye. However, when using the usual blind landmark and palpation method in this region, it     often proves exceedingly difficult or even impossible to obtain peripheral venous access on     patients who are obese, chronically ill, hypovolemic or intravenous drug users. Various     studies have shown that the success rate for establishing a vascular access with ultrasound     compared to blind landmark technique is higher in patients with difficult access. When     ultrasound is used to establish intravascular access, the prerequisite sterile puncture area     can be challenging to meet due to ultrasound gel on the area and the fact that the ultrasound     transducer cannot be wiped clean with alcohol after being in contact with a patient's skin or     blood. A strict sterile procedure is important to reduce complications related to     infection.The traditional way of coping with this is by covering the transducer and the wire     in a long sterile sheet and using sterile gel. The sheet must be tight with rubber band     around the transducer and pulled tightly around the transducer foot to prevent artefacts from     appearing on the screen. This is an expensive and time consuming method, and it still leaves     the problem with gel in the puncture area.      The investigators have developed a method by where all these problems are solved by using, a     slightly modified, commercial drape in combination with the Dynamic Needle Tip Positioning     technique      The investigators hypothesize that it is possible to perform ultrasound-guided venous     puncture with a sterile and dry puncture area and that puncture can be performed proximal and     distal to the traditional puncture side.      It is a procedure presenting study that serves to demonstrate the feasibility of the method     in ten healthy volunteers. The study will take place at Aarhus University Hospital, Skejby.   "
114646|NCT01785212|"     The CUSA (cavitron ultrasound surgical aspirator) is the method of choice for hepatic     resection in our center. Recently a stapler-hepatectomy methods has been developed and     approved for liver surgery using Covidien Endo-Gia stapler. The potential benefit of this     method is a potential shorter transection time compared to the CUSA technique. Thus the     investigators will perform a randomized controlled trial including 20 patients in the     stapler-group and 20 patients in the CUSA control group. Primary endpoint will be transection     speed. Secondary endpoints will be peri-operative (d-1, d0, d1, d3) cytokines concentration,     T cell subsets, blood loss, morbidity, and a cost analysis.   "
114647|NCT01785199|"     Sleep is known to be a dynamic state of consciousness that is characterized by rapid     fluctuations in autonomic activity as well as changes in body postures. Body postures during     sleep influence the severity of sleep-disordered breathing because a supine position is     associated with an increase in upper airway collapsibility and thus an increase in frequency     and duration of snoring and apnea. Use of an adjustable bed to elevate patients' head might     improve those conditions. The purpose of the present study is to determine whether use of an     automatic adjustable bed is associated with reducing sleep-disordered breathing in patients     with suspected obstructive sleep apnea (OSA) due to upper airway problems.   "
114659|NCT01785030|"     Nitrous oxide (N2O) is a gas that is normally used to take away pain and anxiety during     painful medical procedures. However, one of its effects is to also make veins appear larger     and more visible. This is useful when there is a patient who needs to have an intravenous     (IV) needle put in their skin to give them medicine or ﬂuids, but may have veins that are     very hard to see or feel. The mechanism of this observed effect is not entirely clear. The     purpose of this study is to use an ultrasound to directly measure whether there is an actual     change size of veins or change in blood flow in healthy adult volunteers when you give them     50% nitrous oxide, and see whether or not this change in size, or change in flow, is what     causes the changes in visibility or palpability of the vein.   "
114661|NCT01785004|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or omega-3 fatty acids (1 gram of omega-3 fatty acids) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses. This ancillary study (VITAL Adiposity) is being conducted among participants     in VITAL and will examine the effect of vitamin D or fish oil on changes in body composition     and adiposity (baseline compared to 2 year, as measured by anthropometric indices, total and     regional body fat and adipokines) and assess whether changes in cardiovascular risk factors     (lipids, glucose tolerance, blood pressure) are mediated by these parameters. How achieved     25(OH)D levels are affected by body composition and body mass will also be assessed.   "
130449|NCT01577524|"     The purpose of the study is to determine whether diluted Povidone Iodine solution used to     irrigate surgical wounds during spine surgery decreases the incidence of surgical site     infections.   "
114648|NCT01785186|"     This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized,     controlled clinical trial that will compare the efficacy and safety of four experimental four     drug regimens with a standard control regimen in patients with smear positive, pulmonary     tuberculosis (TB). Patients will be randomly allocated to the control or one of the four     experimental regimens in the ratio 2:1:1:1:1. Experimental regimens will be given for 12     weeks. Thereafter, participants in the experimental arms will receive continuation phase     treatment for 14 weeks containing standard-dose rifampicin and isoniazid. All participants     will receive 25 mg of vitamin B6 (pyridoxine) with every dose of INH to prevent INH‐related     neuropathy. Interim analyses will be conducted during the trial for efficacy, with the aim of     identifying experimental arms that perform below a pre‐specified efficacy threshold; these     arms will then be stopped from further recruitment.      Following the first scheduled interim analysis on March 3rd, the Trial Steering Committee     (TSC) followed a recommendation of the independent data monitoring committee (IDMC) and has     stopped the enrolment into two of the arms in the MAMS-TB trial: HRZQ and HR20ZQ, based on     these arms not meeting the pre-specified gain in efficacy over control. Importantly, there     was no safety concern that prompted stopping recruitment to these arms. They recommended that     recruitment to arm 2 (HRZQ) and 3 (HR20ZQ) be terminated as there was insufficient evidence     that these regimens could shorten treatment. Importantly, there was no evidence that either     arm was inferior to standard treatment (the control arm) with regards to efficacy. There was,     however, sufficient evidence that the other intervention arms HR35ZE and HR20ZM could shorten     treatment to continue enrolling patients.   "
114649|NCT01785173|"     Unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) has gained wide popularity and is     one of the most frequently performed diagnostic procedures in Japan and Europe. The technique     of using a cotton pledget soaked with lignocaine and decongestant is quite effective but does     cause some discomfort during application of anesthetic agent to the nasal cavity. Hence, an     effective method to deliver anesthetic agent, using a minimal dose of drugs, and at the same     time maintain a good ﬁeld of vision during endoscopy are all very important.      Using a cotton-tippled applicator to deliver a soaked gauze strip may cause kinking of it     around the nasal vestibule or just in the anterior end of a turbinate. Endoscopic guidance to     deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate.     We hypothesize that a simple endoscopic-guided gauze pledgetting method is more tolerable     than the blind cotton-tippled applicator method to deliver a gauze strip for anesthetizing     the nasal cavity.   "
114650|NCT01785160|"     The primary objective of this trial is to investigate effect of faldaprevir on steady state     pharmacokinetics of raltegravir.      The assessment of safety and tolerability will be an additional objective of this trial.   "
114651|NCT01785147|"     Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy     and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by     subject diary and confirmed by exhaled CO (abstinent < 10 ppm).   "
114652|NCT01785134|"     Obese patients have an increased risk for developing severe metabolic disorders. This risk     can only partly be reduced by weight reduction. The investigators have in a pilot study     investigated if removal of abdominal fat (visceral) in addition to weight loss has additional     beneficial effects on the metabolic profile and weight loss. This study aims to further     investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic     effects.   "
114653|NCT01785121|"     The study objectives are to determine the effectiveness of structured access to a Wii game     computer compared to motivational support only in heart failure patients on exercise capacity     and daily activity. Secondly, to determine the effectiveness of structured access to a Wii     game computer compared to motivational support only in heart failure patients on the combined     endpoint of death, readmission and quality of life.      The following research questions will be addressed:        -  What is the effectiveness of structured introduction and access to a Wii game computer          in patients with heart failure to improve their exercise capacity compared to patients          with heart failure in a control group who only receive motivational support?        -  What is the effectiveness of structured introduction and access to a Wii game computer          in patients with heart failure compared to patients with heart failure in a control          group who only receive motivational support to increase their daily physical activity,          decrease health care use and improve quality of life?        -  What are experiences of heart failure patients and how is their exercise motivation when          they are introduced and instructed to play with a Wii game computer?   "
114654|NCT01785108|"     The objectives of this study is to        -  evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with          Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently          diagnosed Type 1 Diabetes        -  evaluate how the above mentioned treatments influence the immune system of the subjects          and interact with any viral infections        -  evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd)          plus Vitamin D on the immune system, viral infections, and on preservation of residual          insulin secretion in recently diagnosed Type 1 Diabetes   "
114655|NCT01785095|"     The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy     volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation     program.   "
114656|NCT01785082|"     The purpose of this study is to investigate safety and efficacy of intravenously injected     0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on     patients with partial liver resection. The LiMAx-test is compared with an untreated control     group and post-surgical management of both groups is investigated.   "
114657|NCT01785056|"     The purpose of this research is to study the effects of Privigen (intravenous immunoglobulin)     on the skin in patients with scleroderma. Approximately 24 subjects will take part in this     investigator-initiated study at Georgetown University Hospital and Johns Hopkins Hospital.     This study will last for one year (12 months). This research is being done because systemic     sclerosis can cause severe, progressive organ involvement. The investigators hope this study     treatment will improve the outcomes in this disease, including skin, muscle, joint,     gastrointestinal, and lung involvement.   "
114658|NCT01785043|"     Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized,     open-label, parallel-group and active controlled trial   "
114662|NCT01784991|"     This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management     protocol for the treatment of moderate to sever pain in the Emergency Department. Appropriate     patients 60 years and older who present with a condition that causes moderate to severe pain,     according to the attending physician's judgment, in which the physician would order the use     of parenteral analgesia will be enrolled in one of two study arms, 1+1 versus usual care     group. 1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes     if pain persists. Usual care group patients will have pain treated per the discretion of the     attending physician. Respiratory status, vital signs, and pain scores will be monitor to     assess the efficiency of pain control as well as the safety of pain medicine administration     in terms of respiratory depression.   "
114663|NCT01784978|"     The objective of this study is to assess the progression-free survival, of patients who     receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a     first line treatment followed by everolimus when progression occurs.   "
114664|NCT01784965|"     The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a     long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead     to greater weight loss than will a calorie-restricted diet alone in subjects who are older     (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been     selected for study because they are at greatly increased risk to develop type 2 diabetes     (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of     liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse     outcomes.      There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic     control in patients with manifest 2DM. However, there is relatively little information as to     the potential utility of these compounds in nondiabetic individual at greatly increased risk     of 2DM and CVD. This research proposal is aimed at providing some of this information by     quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin     secretion, insulin action, and multiple CVD risk factors in a very high risk group—older,     overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not     surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be     possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin     action.   "
114665|NCT01784952|"     We examined whether a substitution of whole grains and legumes for refined rice in a high     carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of     this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.   "
114666|NCT01784939|"     HFE(High iron FE)-related hereditary hemochromatosis has a highly variable penetrance. No     phenotypic or genetic markers can predict the disease. The Iron Reabsorption Index (IRI),     recently described by our group, correspond to the daily reabsorbed iron for a subject whose     iron stock is stable and less than 50 µg / L.      The IRI is constant over time, reflecting the importance of the underlying functional     deficit.      Hepcidin / ferritin (H / F) ratio may be an independent and constant over time marker of     disease stage.No data are available on the validated values of this ratio.      The goal of this project is to determine the intra-individual variations of the H / F ratio     over time during maintenance therapy and to assess the correlation with the IRI.   "
114667|NCT01784926|"     In this prospective, randomized study The investigators will include 80 patients with late     intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain     normal visual function, these patients needs surgery. Today, there are two different methods     used for this condition; scleral suturing of the capsular complex or exchange of IOL to an     iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and     dis-advantages for these two methods.   "
114668|NCT01784913|"     In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a     therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability     of UV1 as well as immunological response will be assessed. The purpose of this study is to     select a biological dose of peptides for further clinical trials.      Main treatment period is completed and reported. Follow-up ongoing.   "
114669|NCT01784900|"     Treatment by association of complete surgical excision of the lesions and intraperitoneal     immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis   "
114670|NCT01784887|"     Utilizing wound healing trajectory analysis, patient-reported pain and QOL assessment,     quantitative bacteriology, and inflammatory infiltrate quantification, an improvement in     wound healing will be observed on a cellular, histomorphological and clinical level in the     presence of a bioelectric dressing applied in conjunction with SOC.   "
114686|NCT01784679|"     HIBM is a severe progressive myopathy that typically presents in early adulthood as weakness     in the distal muscles of the lower extremities and progresses proximally, leading to a loss     of muscle strength and function, and ultimately a wheelchair-bound state. The rate of     progression is gradual and variable over the course of 10-20 years or longer. There is a need     to better understand the disease-specific features of HIBM to heighten disease awareness;     facilitate early diagnosis; identify patients; expand knowledge of the clinical presentation,     progression and variation of the disease; identify and validate biomarkers and other efficacy     measures; inform on the design and interpretation of clinical studies of investigational     products; and eventually to optimize patient management.   "
115212|NCT01777815|"     The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000     Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in     patients with mitral regurgitation.   "
114687|NCT01784666|"     This study investigates the medication isradipine, which is currently approved by the FDA to     treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or     placebo (contains no active medication) will be used as an add-on to lithium, valproate,     and/or atypical antipsychotics for individuals currently experiencing a major depressive     episode. Our hypothesis is that isradipine will be superior to placebo in improving     depressive symptoms.   "
115042|NCT01780051|"     This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study.     The objective of the study is to compare the pharmacokinetic properties after     co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of     combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy     male volunteers.   "
114671|NCT01784874|"     The aim of this study is to generate data on immunogenicity and safety of Purified Vero     Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the     registration of VRVg in the USA.      Primary Objectives:        -  To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of          subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day          42.        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5          IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%.      Secondary Objectives:        -  To assess the clinical safety of VRVg each vaccine after each vaccine injection when          administered in a pre-exposure schedule.        -  To describe the immune response induced by each vaccine 21 days after two vaccinations          (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of          the primary vaccination series.        -  To describe antibody persistence at 6 and 12 months after the first vaccination in all          subjects, and at 18 and 24 months in a subset of subjects.   "
114672|NCT01784861|"     This study is to evaluate the combination of an investigational drug X-82 with everolimus in     the treatment of pancreatic neuroendocrine tumors.   "
114673|NCT01784848|"     Phase 3, unicentric, randomized clinical trial, with allocation concealment and     intention-to-treat analysis to evaluate the efficacy of videolaparoscopic Roux-en-Y     Gastroplasty to decrease the prescription of antihypertensive drugs maintaining normal levels     of blood pressure, decrease systemic arterial blood pressure and other risk factors for     cardiovascular events compared to clinical treatments of patients with arterial hypertension.   "
114674|NCT01784835|"     The application of osteopathic manipulative treatment (OMT) in preterm infants has been     demonstrated to be effective in reducing length of stay (LOS). The scope of the present study     is to investigate the association between earlier exposure to OMT and reduction of LOS in     premature infants   "
114675|NCT01784822|"     The objective this study is to collect post-market data on the performance of the Zenapro™     Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the     repair of ventral hernias.   "
114676|NCT01784809|"     The proposed study addresses a significant public health threat of Human immunodeficiency     virus (HIV) and sexually transmitted infections (STIs) among drug involved women on     probation, parole or other community supervision. This randomized controlled trial aims to     test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug     use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in     increasing condom use and decreasing the incidence of sexually transmitted infections (STIs)     among 420 drug-involved, female offenders in a large community court setting in New York     City, compared to a non-media version of the same intervention (Traditional WORTH) and to a     4-session Wellness Promotion condition.   "
114677|NCT01784796|"     The purpose of this study is to determine how a stress reduction program, called Mindfulness     Based Stress Reduction (MBSR), compared to a health education program, improves well being     and reduces the risk of heart disease in women Veterans.   "
114678|NCT01784783|"     The purpose of this study is to investigate the impacts of home-based couple HIV-testing and     counseling and male partner education on partner HIV testing and other critical maternal and     infant health outcomes during pregnancy and the postpartum period. Additionally, the study     seeks to assess the cost-effectiveness of this approach.      Involvement of men during the antenatal and postpartum period, including HIV testing of male     partners, can have substantial benefits for women and infants. In observational studies, male     participation in antenatal care has been associated with increased uptake of prevention of     mother-to-child transmission (PMTCT) interventions, and more recently, a study in Kenya found     a significant HIV-free survival benefit for children of HIV-infected women whose male     partners attended antenatal care where couple HIV testing was offered. In this study only 31%     of ~450 men invited for counseling and testing came to clinic, highlighting the challenges     faced across sub-Saharan Africa when trying to access male partners of pregnant women.      In areas of high HIV-1 prevalence, high levels of male involvement may be readily achievable     because home-based counseling and testing is highly acceptable and the benefits of male     participation and HIV testing extend to HIV-uninfected pregnant and postpartum women and     infants. Reaching out to men during pregnancy may reduce incident HIV infection and vertical     transmission among these women, but efforts to engage men in antenatal care in Western Kenya     have thus far achieved limited success. This intervention may achieve gains beyond prevention     of maternal and infant HIV-1 acquisition through identification of HIV-infected men who would     otherwise not learn their status or delay treatment, and by improving child health through     targeted education of male partners. When administered in a home-based setting simple,     established interventions such as the promotion of exclusive breastfeeding have been shown to     be associated with significant reductions in child mortality. Home-based approaches also lend     themselves to integration with targeted interventions such as promotion of HIV testing among     male partners of at-risk pregnant women. Furthermore, a successful HIV testing program for     male partners of pregnant women has potential to reach a large number of men who may be     unaware of their HIV status or who are HIV-infected but not in care, providing linkages to     treatment clinics and promoting prevention interventions, such as safe sex and voluntary male     circumcision for those who are uninfected.      In this randomized clinical trial up to 600 couples (300 in each treatment arm) will be     randomized to standard antenatal care or home-based partner education and HIV testing (HOPE)     as part of routine pregnancy services. Women will be enrolled at the antenatal clinic in     Kisumu District Hospital, Kisumu, Kenya. Couples in the control group will receive the HOPE     Intervention, featuring home-based couple counseling and HIV testing as well as key     educational messages concerning HIV prevention behaviors, facility delivery, exclusive     breastfeeding, and post-partum family planning. Women in the control arm will be invited to     bring their male partners to the antenatal clinic for voluntary clinic testing and     counseling. Women will be followed up at clinic visits 6-weeks and 14-weeks postpartum and     again with their male partner 6-months post-partum. These follow-up visits will include     questionnaires to measure uptake of HIV testing, facility delivery, exclusive breastfeeding     and postpartum contraceptive use as well as linkage to HIV care. Cost-effectiveness of the     intervention will also be evaluated in order to inform future scale-up.      First, the investigators hypothesize that successful implementation of HOPE will result in     higher uptake of male partner HIV testing, couple testing and disclosure of HIV status. The     investigators also hypothesize that there will be benefits to HIV-infected and HIV-uninfected     women and their children who will have improved uptake of interventions to improve maternal     and child health. Specifically, the investigators anticipate higher levels of facility     delivery, optimal breastfeeding practices, and post-partum contraceptive use, as well as     increased uptake of antiretroviral treatment for HIV+ women in the intervention arm, relative     to the control arm. Second, the investigators hypothesize that greater than 85% of     HIV-1-infected men identified through home-based partner education and testing (HOPE) will     access care and treatment services, and, overall, more women in the HOPE arm will know their     partners' status at each time point and more partners will be in care and treatment. Third,     the investigators predict that uptake of counseling and testing and HIV prevalence among male     partners and family members will be high enough to make this approach cost-effective from     both payer and societal perspectives.   "
114679|NCT01784770|"     To collect retrospectively the efficacy and safety information of azithromycin IV on patients     with Legionnaires' disease related to their appropriate use in daily practice.   "
114680|NCT01784757|"     A study to investigate which of two different tablet formulations of ODM-201 is best suited     for use in the further development of the compound in the treatment of metastatic     chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the     bioavailability study will be able to receive further treatment with the current capsule     formulation of ODM-201 until progression of their disease with the safety and tolerability of     ODM-201 being assessed throughout.   "
114681|NCT01784744|"     The febrile hypothesis of Autism Spectrum Disorder (ASD) stems from the observation that     clinical symptoms improve during fever. This fever induced amelioration of symptoms could be     due to one of three possible causes, (1) the direct effect of temperature; (2) a resulting     change in the immune inflammatory system function associated with the infection or fever;     and/or (3) and increase in the functionality of a previously dysfunctional Locus     Coeruleus-Noradrenerigic (LC-NA) system. Little has been done to explore the potential direct     effect an increased body temperature may have on autism symptomology. Parental reports have     demonstrated that during febrile episodes children with ASD have improved social cognition     and language skills, and decreased disruptive behaviors. In order to further explore the     direct temperature effect, further investigation is needed, which the investigators propose     below. The investigators propose to complete a one year double blind crossover study with 15     children with ASD between the ages of 5 and 17 years old. Five children with ASD will     complete a control protocol prior to beginning the full protocol with 10 additional ASD     children. This will allow for any needed amendment of protocol parameters prior to completion     of the full protocol.   "
114682|NCT01784731|"     Currently, office visits at general practitioners is free of charge for patients. However,     public commissions and the Danish Economic Council have suggested to implement user charges     for services that currently is free of charge. The aim of this study is to examine the     consequences of introducing user charges for general practitioner services. Data for the     project will be collected from patients who have an appointment with a general practitioner.     Patients will be asked whether they are willing to pay a specified amount for the     consultation that they have scheduled. After the consultation, the GP register diagnoses.   "
114683|NCT01784718|"     This is a single patient compassionate use protocol to determine whether Buphenyl     (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.   "
114684|NCT01784705|"     Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective     disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under     debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate     the neural networks of the human brain and improve cognitive performance in healthy subjects.     Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the     investigators will study the effect of transcranial bright light treatment via ear canals on     depressive and anxiety symptoms in patients suffering from SAD in randomized controlled     double-blind study design.   "
114685|NCT01784692|"     This will be a small study aimed at determining the effects of oral Immulina consumption on     the immune system in elderly individuals.   "
114688|NCT01784653|"     The purpose of this study is to test the effects of a computerized, self-directed     Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison     to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and     substance use. The investigators hypothesize that both iMET and MET will be more effective     than TAU in engaging/retaining patients in treatment and in reducing substance use during a     12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be     as effective as the clinician-guided MET in increasing treatment engagement and abstinence     during the 12-months follow-up period.   "
114689|NCT01784640|"     This phase I trial studies the side effects and the best dose of Hsp90 inhibitor AUY922 when     given together with pemetrexed disodium in treating patients with previously treated stage IV     non-small cell lung cancer. Hsp90 inhibitor AUY922 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     pemetrexed disodium, work in different ways to stop the growth of tumor cell, either by     killing the cells or stopping them from dividing. Giving Hsp90 inhibitor AUY922 together with     pemetrexed disodium may kill more tumor cells   "
114690|NCT01784627|"     The goal of this project is to test the effectiveness of a computer-facilitated alcohol     screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients     in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize     that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI     will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to     Treatment As Usual (TAU).   "
114691|NCT01784614|"     The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy     Japanese participants. The study has four treatment periods. Participants will receive a     single dose of LY2624803 or placebo in each treatment period.   "
114692|NCT01784601|"     Primary objective of this study is to find out the incidence of hemi-diaphragmatic palsy     associated with interscalene block done under ultrasound guidance.      Primary hypothesis:      • There is an incidence of hemidiaphragmatic palsy ranging fron 33-100 % after an     interscalene block.      Secondary hypothesis        -  The incidence of hemidiaphragmatic palsy is much less than 33% when the block is done          using ultrasound.        -  The incidence of hemi-diaphragmatic palsy is directly proportional to volume of local          anaesthetic injected.        -  The incidence of hemi-diaphragmatic palsy is directly proportional to concentration of          local anaesthetic injected.   "
114693|NCT01784588|"     The purpose of this research study is to compare the treatment device (Solyx) to a different     mesh sling or control device (Obtryx II) for the treatment of symptoms for SUI. Safety     information and patient outcomes will be collected for three (3) years and evaluated.   "
114694|NCT01784575|"     Numerous factors prevent consumers from making effective use of publicly reported information     about the quality of health care, including limited recognition that quality of care varies     between physicians, lack of awareness of the existing quality websites, limited internet     access, and low health literacy and numeracy. In the proposed randomized controlled trial we     will evaluate the impact of providing assistance for using and interpreting information about     the quality of pediatric care on the Massachusetts Health Quality Partners Quality Insights     website among a population of low income pregnant women. Results of the study will advance     our understanding of effective strategies for overcoming barriers to using publicly reported     information among vulnerable populations.   "
114695|NCT01784562|"     The aim of the study is to assess safety, tolerability and clinical effects of different     doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension     (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH     trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.   "
114696|NCT01784549|"     -  The investigators hypothesized that NSCL patients receiving therapy based on their          baseline tumor markers levels would attain higher response rates than patients in the          control arm receiving non customized therapy.        -  patients with stage IIIA(N2) NSCLC will be randomized in a 2:1 ratio to customized          therapy based on biomarkers status (ERCC1, RRM1, TS and EGFR mutation) vs standard          chemotherapy.        -  The primary objective of this multicenter trial is to compare pathological complete          response of all subjects randomized, by treatment arm.        -  Secondary objectives are to compare all randomized subjects by treatment arm for:          response rate, disease-free survival, overall survival, one, two and three year survival          and safety profile.      The study is expected to demonstrate both the feasibility of this approach and the logistic     problems associated with a biomarker-driven therapeutic strategy in NSCLC.   "
114697|NCT01784536|"     The purpose of this study is to examine the effects of oritavancin on the in vivo activities     of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT 2, and XO using a Cooperstown 5 + 1 cocktail     in an open label, single arm manner.   "
114698|NCT01784523|"     In this multi-center international study, our aim is to determine the effectiveness of HCQ     for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients     without systemic autoimmune diseases.   "
114699|NCT01784510|"     Randomized controlled trial comparing between two technique of laparoscopic sleeve     gastrectomy for treatment of morbid obesity. In the first technique the investigators started     dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was     only 2 cm. The main primary outcome measure was weight loss.   "
114700|NCT01784497|"     Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver     Transplantation   "
114719|NCT01784250|"     The aim of the study is to determine the efficacy of clonidine and propranolol for transient     anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery     of third molar.   "
114731|NCT01784094|"     This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and     no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation     of CTMM with low back pain symptoms, disability, and functional measures. The investigators     hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will     be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively     correlate with low back pain symptoms, disability and functional measures.   "
114701|NCT01784484|"     BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in     chronic hepatitis C, however limited data are available in chronic hepatitis B and in non     alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis     in patients with different chronic liver disease (elevated liver enzymes) who are being     followed up in the liver unit and to find associated factors with significant fibrosis and     cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will     be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver     stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink     consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be     distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be     higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the     same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values     will emerge as the most important independent predictive variable of fibrosis and not serum     ALT. A significant correlations between soft drink and coffee consumption with the extent of     liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that     screening patients with elevated liver enzymes is beneficial and detect earlier the presence     of liver fibrosis mainly in patients with NAFLD.   "
114702|NCT01784471|"     This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms     attributable to diabetes or peripheral vascular disease will be screened . Subjects meeting     inclusion criteria will sign informed consent and enrolled. All 30 subjects will be treated     with the Magic Foot™.      If there is any significant improvement in ICG or foot symptoms as obtained from self     evaluation questionnaire, a further 30 subjects will be enrolled.   "
114703|NCT01784458|"     -  Intra-abdominal pressure(IAP) is defined as a steady state pressure of the abdominal          cavity        -  many studies have proved IAP as a prognostic factor that elevated IAP influences          hemodynamics and multiple organs dysfunction        -  In previous studies, most of them was based on the septic patients of medical diseases.          And it is rare about sepsis of surgical diseases such as traumatized or postoperative          patients        -  We hypothesized that intra-abdominal hypertension may affect clinical course such as          length of stay of intensive care unit, weaning of mechanical ventilation, proceeding of          enteral feeding and mortality        -  Our study was aimed to investigate prevalence of IAH and risk factors and to analyze          clinical course and prognosis influenced by IAH in surgical patients with severe sepsis   "
114704|NCT01784445|"     Diclophenac potassium and ceftazidime are commercially available drugs that are used in     various clinical situations. They are safe and known for years. Diclophenac potassium and     Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis     and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is     currently standard treatment for prevention of (PEP) while ceftazidime is possible     alternative treatment for patients with contraindications for nonsteroidal medicines. The aim     of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.   "
114705|NCT01784432|"     Muscle performance is largely influenced by modulations in gene expressions of muscle tissue.     In this context, low-level laser therapy has been used to improve muscle performance in     experimental models and human researches. Thereby, the investigators examined modulations on     global gene expression of muscle tissue influenced by exercise associated to low-level laser     therapy.   "
114706|NCT01784419|"     This is a study of the short-term effects of ivacaftor on sweat chloride concentration and     lung function in cystic fibrosis (CF) patients who fall outside current FDA approval. This     new, first of its kind drug is approved for use only in CF patients with the G551D mutation     in whom it safely confers considerable benefits. However, it is highly likely that CF     patients with many other mutations can benefit similarly from this drug, some of whom can be     identified by phenotype or genotype.      We will enroll up to 30 CF subjects with clinical presentations in which there is one or more     signs of residual CF channel function. The signs of residual function include: normal     digestion, concentration of chloride in sweat between 55 and 85, or milder than expected CF     disease in a CF patient with severe gene mutations. The primary outcome measure will be the     difference in sweat chloride concentration measured in subjects on placebo and on ivacaftor.     Secondary outcome measured will be lung function.   "
114707|NCT01784406|"     Women treated for gynaecological cancer perceive many difficulties in life on the personal,     social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the     hospital where the main purpose is to improve survival. However, the women are very nervous     before follow-up visits and although they feel safe about them, they express that their needs     of psychosocial care and self-management support are not fulfilled.      The proposed study will test a person-centred intervention tailored the women's needs in a     randomised controlled trial. The intervention will be based on the method Guided Self     Determination (GSD), which has proved able to realize empowerment in practice in     relationships between patients and healthcare professionals. GSD involves systematic use of     condition-adjusted worksheets ('reflection sheets'), and advanced professional communication.     Using reflection sheets filled out by each woman as the starting point for communication,     problem solving will be tailored her personal needs. We expect that the intervention has the     potential to support the women in better managing specific complications and difficulties     related to concerns about recovery, body perception, fertility and establishment of intimate     relations with their partner, all aspects important for the women's quality of life in the     follow-up period after cancer diagnosis and treatment. The study will be the first to test     GSD in cancer patients.   "
114728|NCT01784133|"     The purpose of this study is to evaluate th safety and efficacy of one-daily topical     application of CLS001 low, mid and high dose compared to vehicle gel in subjects with     papulopustular rosacea.   "
114729|NCT01784120|"     To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer        1. Primary Purpose: response rate        2. Secondary purpose: toxicity, progression-free survival, overall survival   "
114730|NCT01784107|"     Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan     and Ifosfamide.      Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.   "
114867|NCT01782326|"     This study will assess the efficacy, safety and tolerability of QVA149 in patients with     moderate to very severe COPD.   "
114708|NCT01784393|"     Pain from bone metastases of breast cancer origin is treated with localized radiation.     Modulating doses and schedules has shown little efficacy in improving results. Given the     synergistic therapeutic effect reported for combined systemic chemotherapy with local     radiation in anal, rectal, and head and neck malignancies, the investigators sought to     evaluate the tolerability and efficacy of combined capecitabine and radiation for palliation     of pain due to bone metastases from breast cancer Hypothesis: Given the hypothesis that     regimens employing greater intensity radiation yield higher rates of pain relief,     radiosensitization using a tumor targeted drug like Xeloda should improve the rate of     complete pain relief as compared to radiosensitization with 5FU alone.      Primary Objective:      To determine the frequency and duration of pain relief and narcotic relief for the proposed     regimen.      Secondary Objective:      To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer     patients with bone metastases.   "
114709|NCT01784380|"     To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic     indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）.     Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic     effect indicatrixes of women with PCOS.   "
114710|NCT01784367|"     The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump     driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid     intubation and invasive mechanical ventilation in patients with acute respiratory failure     retaining carbon dioxide due to the failure of their ventilatory muscle pump and not     responding to prior non-invasive mask ventilation.   "
114711|NCT01784354|"     The use of acupressure will be compared to targeted Raynaud's education and will evaluate     the` frequency, duration and pain of Raynaud's attacks.   "
114712|NCT01784341|"     The overall aim of this project is to compare sleep patterns and melatonin profiles in     individuals with bipolar disorder during depression and after remission. The hypothesis is     that sleep time, rest-activity cycles and melatonin onset will be delayed during depression     and become less delayed after remission.   "
114713|NCT01784328|"     To compare the Peristeen Anal Irrigation System with conservative bowel management in a     prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel     dysfunction.   "
114714|NCT01784315|"     This research is intended to study the efficacy of CQ alone for P.vivax infection and also to     study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. For this     study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone since masking     effect over one another was found when CQ is given with PQ. So the investigators are not sure     whether the recurrence is due to resistance to CQ or CQ concentration in blood is below     therapeutic level or it is due to PQ is in inadequate dose. From this study the investigators     will get findings like may be CQ is still working for P.vivax or no longer working for     P.vivax due to resistance developed by P.vivax parasites. So for P.vivax which is not     responding to CQ therapy, the investigators will go for second line treatment with ACT in a     similar fashion as it is given for P. falciparum infection in Bhutan. And if the     investigators find CQ is still working for P.vivax infection, the next level of study will be     to compare higher dose of PQ with standard dose of PQ ( as practiced now) in lieu of bringing     down the relapse rates in P. vivax infection.   "
114715|NCT01784302|"     This study seeks to address the question of whether antacids or multivitamins influence the     pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise     the dosing of raltegravir when co-administered with antacids or multivitamins.   "
114716|NCT01784289|"     White adipose tissue-related diseases spread from excess (obesity) to lack (lipoatrophies)     through aberrant distribution (lipodystrophies), these 3 different disorders being     paradoxically able to induce a metabolic insulin resistance syndrome. The respective part of     quantitative and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and     muscle insulin resistance, low-grade fat inflammation and immune alterations are not     perfectly understood in the metabolic syndrome yet. Therefore, the aim of this study is to     assess different cytokines, especially interleukin 7, and metabolic parameters as well as fat     mass distribution with DEXA and RMN, in different models of fat distribution, including     normal-weight, obese and lipodystrophic patients. A plasma serum, gene and adipose tissue     bank will be constituted at the same time to improve our knowledge in disorders linking fat     mass, insulin resistance and immunity, especially in lipodystrophies, a rare monogenic model     of insulin resistance.   "
114717|NCT01784276|"     Specific Aims Our study objective is to investigate if video peer modeling before the visit,     plus immersive virtual reality during a preventive dental visit, reduces dental fear and     uncooperative behaviors among children with ASD.      SPECIFIC AIM: To pilot and test the feasibility and effectiveness of video peer modeling and     immersive virtual reality in reducing dental fear among children with autism undergoing     preventive dental visits.      Methods: The investigators will enroll eighty (80) subjects aged 7-17 years with a known     diagnosis of autism, who had a history of dental fear, per parental report.      Study hypotheses:      The primary hypotheses of interest are:      (i) The mean change in the Venham Anxiety Score (VAS) over the 4 month period in children     with ASD who receive the video intervention (Group B) is different from the mean change in     the VAS over the 4-month period in children with ASD in the control group.      (ii) The mean change in the VAS over the 4-month period in children with ASD who receive the     immersive VR intervention (Group C) is different from the mean change in the VAS over the     4-month period in children with ASD in the control group.      (iii) The mean change in the VAS over the 4-month period in children with ASD who receive the     video intervention plus the immersive VR intervention (Group D) is different from the mean     change in the VAS over the 4-month period in children with ASD in the control group.      The secondary hypothesis is:      (i) The mean change in the Venham Behavior Score over the 4-month period in children with ASD     in Group D is different from the mean change in the Venham Behavior Score over the 4-month     period in children with ASD in Group B or C.   "
114718|NCT01784263|"     The study is a randomized controlled trial to examine the efficacy of individual cognitive     behavioral therapy (CBT) relative to a standard community treatment, in youngsters with     autism spectrum disorder (ASD). The individual CBT program has been tailored over the last     five years to the clinical needs of high-functioning youth with ASD.   "
114720|NCT01784237|"     A sniff test for nasal patency is a common method before ultrathin transnasal     esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet     there is no objective method to select an appropriate meatus insertion site (MIS) where     tolerance and epistaxis rate can be improved.      The investigators hypothesize that that an objective anterior rhinoscopy (to be more     specific, the investigators term it anterior meatoscopy) method might be more effective     than the subjective breathing-in method (sniff test) to select the appropriate meatus     insertion site, thus reducing nasal bleeding and nasal discomfort.      The aim of this study is to evaluate the effectiveness of an endoscopic meatus scoring scale     (EMSS) by anterior meatoscopy (AM) to select a MIS on patient tolerance and adverse events     during nasal anesthesia and UT-EGD.      The investigators will perform a prospective randomized-controlled trial to compare patient     tolerability and adverse events during nasal anesthesia and endoscopy between the AM-selected     and self-selected MIS. A total of 233 consecutive patients with epigastric discomfort     (symptoms of non-ulcer dyspepsia) will be included in the study in a large tertiary referral     hospital in Taiwan.   "
114721|NCT01784224|"     The main purpose of this study is to investigate voice production, speech intelligibility and     routine physiologic parameters associated with the Blom low profile voice inner cannula and     the Passy-Muir one-way tracheotomy tube speaking valves.      Additionally, the purpose of this study is to investigate the effects (if any) associated     with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube     speaking valves on swallowing behavior and biomechanical movement of the hyolaryngeal complex     during routine diagnostic modified barium swallowing evaluations.   "
114722|NCT01784211|"     The purpose of this study is to measure how much of the study drug or insulin glargine gets     into the blood stream and how long it takes the body to get rid of it. The effect of exercise     will also be evaluated.      This study has two parts. In Part A, each participant will receive a daily injection of     LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B.     In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with     or without exercise. Part B lasts about 6 days.      Participants will remain on their regular physician-prescribed meal time insulin throughout     the study.   "
114723|NCT01784198|"     Protein is an essential part of our diet. It is used to build muscle and body tissue, send     signals throughout our body and to support the immune system. Dietary protein is even more     crucial during pregnancy as it is needed for healthy growth and development of the baby.     There is very minimal data available on how much additional protein is required during     pregnancy. Current recommendations are based on older techniques such as nitrogen balance     studies of non-pregnant adults and minimally based on pregnancy specific data. There is no     scientific information regarding the amount of protein needed during different stages of     pregnancy.      The investigators hypothesize that the current recommendations of protein intake during     pregnancy are underestimated.      The goal of this study is to measure protein requirement in healthy pregnant women     (19-35y)using a more quick and modern technique called the indicator amino acid oxidation     technique (IAAO).   "
114724|NCT01784185|"     The study has been designed to evaluate the clinical application of the new virtual     bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or     enlarged lymph nodes. The software uses data from thorax CT scan and enables airway     segmentation and reconstruction simultaneously with predefined mediastinal targets. The most     suitable sites for transbronchial needle aspiration are displayed on the internal surface of     the airways showed in VB mode.      The diagnostic yield of the new system-assisted TBNA will be compared to the reference method     (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node     enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods.     Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of     the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic     material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to     the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained     with the two methods will be assessed and compared.   "
114725|NCT01784172|"     The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA）     for simple female stress urinary incontinence.   "
114726|NCT01784159|"     Platelet activation is an important factor in the pathogenesis of microvascular thrombosis     characteristic of infections. Microthrombosis may be related to the progression of     dysfunction during sepsis. Several drugs were tested in order to directly regulate blood     clotting. However, there is a lack of studies on aspirin use in sepsis. Observational studies     have demonstrated a decreased morbidity and mortality of sepsis with previous use of aspirin.     However, no prospective randomized studies regarding this intervention were done. The     objectives of this study are to evaluate the impact of the use of aspirin in reducing organ     dysfunction measured by SOFA score on the seventh day, and assess its effect on the duration     of mechanical ventilation, ICU and hospital stay, as well as platelet activity, inflammatory     and prothrombotic activity. Thus, adult patients with severe sepsis and / or septic shock     with less than 48 hours will be randomly allocated into two groups. Group 1 (ASA) will     receive aspirin 200 mg and Group 2, placebo either once daily for 14 days. The inflammatory     status and coagulation will be collected either in the D0 and D3, with measurements of     interleukin 6, interleukin 10 and interleukin-8. The coagulation profile will be analyzed by     measuring thrombin-antithrombin complex, thrombin time, d-dimer and tissue factor. The     platelet activity will be evaluated by testing platelet function (PFA) and by measurement of     urinary metabolites and thromboxane.   "
114727|NCT01784146|"     Objective: To assess the influence of nebulization with bronchodilators carried by the heliox     coupled to PEP in the distribution of compartimental lung volumes in asmathic adults and to     correlate with pulmonary function data. Methods: A controlled randomized trial involving 27     patients divided into four groups: heliox + PEP, oxygen + PEP, heliox and oxygen. After the     initial evaluation, it was placing 89 reflective markers attached to the surface of the trunk     and images acquired by optoelectronic plethysmography (OEP) of six cameras. Three slow vital     capacity maneuvers and quiet breathing regarded as phase control. After the control phase,     all patients underwent nebulization with a distribution noninvasive system, semi-closed using     10 drops of Fenoterol Bromide and 20 drops of Ipratropium.   "
114732|NCT01784081|"     The main purpose of this study is to evaluate the acceptance by patients with metastatic     pancreas cancer of integrating palliative care with usual cancer treatment. Palliative care     intervention will involve use of pancreas cancer-specific decision aides (iPC3)about     prognosis, treatment choices, and advance care planning for patients facing a treatment     decision as well as symptom assessments. We hypothesize that palliative care consultations     with iPC3 will be accepted, symptoms can be diminished, information can be received in a way     that improves choices, and that the quality of care can be improved.   "
114733|NCT01784068|"     The main purpose of the study is to investigate whether nilotinib treatment can be safely     suspended with no recurrence of CML in selected patients who responded optimally on this     treatment   "
114734|NCT01784055|"     To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery     System   "
114735|NCT01784042|"     The over-reaching goal of this study is to test the merit of combining dietary energy     restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention     strategy in overweight and obese women at high risk.   "
114736|NCT01784029|"     To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU     weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of     vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly     Hispanic and black adolescents with vitamin D deficiency [25(OH)D level <20 ng/ml] by     assessing change in 25(OH)D levels before and after 8 weeks of treatment.      To compare the effects of vitamin D repletion [25(OH)D level >20 ng/mL] on selected     musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black     adolescents with vitamin D deficiency [25(OH)D level < 20 ng/mL].      Hypothesis 1: Increase in vitamin D level will be associated with improvement in     musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist     circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.   "
114737|NCT01784016|"     This trial aims to determine whether dopamine D3 receptors are elevated in smokers versus     nonsmokers and whether correlations exist between D3 receptor binding potential (BP) and     functional MRI (fMRI) reactivity to smoking cues, which has been associated with smoking     relapse vulnerability.      Neuroimaging measures of D3 BP and smoking cue fMRI reactivity will be collected concurrently     in otherwise healthy nicotine-dependent smokers and age-matched nonsmokers using a 3 Tesla     MRI scanner configured to conduct fMRI and Positron Emission Tomography (PET).      We will measure D3 receptor BP using radiolabeled [11C]-(+)-PHNO, which has a relatively     higher affinity for D3 versus D2 receptors.      We hypothesize that D3 BP will be elevated in smokers versus nonsmokers and that in smokers,     there will be a positive correlation between smoking cue fMRI reactivity and D3 BP.   "
114738|NCT01784003|"     The proposed study aims to characterize biological ankle joint function during walking and     running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle     joint torque and angle data will be collected from non-amputees while walking and running at     multiple speeds and slopes. This data will be used to develop control parameters for a     powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a     powered prosthesis worn by people with below the knee amputations.   "
114739|NCT01783990|"     The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also     called HU) in children with sickle cell disease could prevent organ damage, especially in the     spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung     disease, stroke, and blood infection.   "
114740|NCT01783977|"     NOTE: This study has stopped enrolling new participants, and all study vaccinations for     currently enrolled participants have been stopped.      Currently, there are no vaccines approved for the prevention of HIV infection, but there are     many clinical trials taking place that are studying experimental HIV vaccines. The purpose of     this study is to evaluate the safety and tolerability of three different HIV vaccine     schedules in healthy, HIV-uninfected adults.   "
114741|NCT01783964|"     This study is performed to measure the quantity of i.v. applied elacytarabine that leave the     body, by which route and how fast.   "
114742|NCT01783951|"     The purpose of this study is to evaluate the antitumor effect and safety of clinical     effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK)     for advanced gastric cancer.   "
114743|NCT01783938|"     The purpose of this study is to evaluate the safety and efficacy of a sequential combination     therapy of Nivolumab and Ipilimumab   "
114744|NCT01783925|"     The objective of this PMS is to gain information about safety and efficacy in real practice     as a regulatory commitment required by MFDS   "
114745|NCT01783912|"     This study tests whether pre-cessation interventions known to be effective in the general     population will increase acceptance of evidence-based treatment, engagement and compliance     with that treatment and initial quitting success. One hundred and seventy two patients will     be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to     those diagnosed with persistent and serious mental illness. All participants will receive two     group sessions (40 minutes each) modeled after Kicking Butts, a group-based quitting     preparation program used for the past four years in two Milwaukee CSP programs run by     Wisconsin Community Services. Individuals will then be randomly assigned to the experimental     and control conditions (n=86 each). Experimental subjects will receive four evidence-based     preparatory interventions (motivational interviewing, smoking reduction, practice quit     attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).     Attention control subjects will also receive four individual sessions of the same duration.     However their individual sessions' content will be a discussion of the personal relevance of     the group material and will not include any of the preparatory interventions. Data will be     collected via brief surveys taken pre-intervention, at the end of the last individual     session, and three months later and from a database provided by the Wisconsin Tobacco Quit     Line (WTQL).   "
114893|NCT01781988|"     Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and     thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to     platinum agents 、 gemcitabine and pemetrexed respectively.      Tailored therapy using these molecular determinants suggested patient benefit in a previously     reported phase 2 trial. Here, we designed a study for an individual patient analysis of     prospectively accrued patients who were treated with the personalized therapy approach     versus other standard approaches.   "
114748|NCT01783873|"     Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to     induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular     weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding     phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new     equipment will allow the realization of specific standardized bronchial challenges (BC) to     occupational agents. Thus, we propose to study in more detail the cellular mechanisms     involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled     study.   "
114749|NCT01783860|"     One hundred patients with the diagnosis of posterior blepharitis based on history taking and     proper physical examinations by two experienced ophthalmologists will include in the study.      Patients will diagnose with posterior blepharitis if they score at least one in two symptoms     (based on a subjective grading scale) and two signs (based on an objective grading scale) of     posterior blepharitis according to study criteria. Patients will exclude if they have the     following criteria: age< 12 years old,history of previous ocular or lacrimal surgery,previous     usage of contact lenses,any history of ocular allergy,history of systemic diseases with     ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in     the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity     to cyclines.      Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the     first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours     for one month) in a double-blinded fashion. each patients in both treatment groups will     accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes     each in the treatment period. Symptoms and signs were recorded for each patient in two     treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61     after treatment.   "
114750|NCT01783847|"     The pathophysiology of Traumatic Optic Neuropathy (TON) is thought to be multifactorial, and     some researchers have also postulated a primary and secondary mechanism of injury.TON is     categorized as direct or indirect.In indirect TON cases, the injury to the axons is thought     to be induced by shearing forces that are transmitted to the fibers or to the vascular supply     of the nerve. Studies have shown that forces applied to the frontal bone and malar eminences     are transferred and concentrated in the area near the optic canal. The tight adherence of the     optic nerve's dural sheath to the periosteum within the optic canal is also thought to     contribute to this segment of the nerve being extremely susceptible to the deformative     stresses of the skull bones. Such injury leads to ischemic injury to the axons of the retinal     ganglion cells within the optic canal. At present, no studies validate a particular approach     to the management of TON. There are three management lines for these patients that include     1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and     3)surgical intervention. Generally no line precedes the others and additionally, medical or     surgical interventions may result in serious side effects or complications. In 2005, the     results of the Corticosteroid Randomization after Significant Head Injury (CRASH) trial     raised concerns regarding the use of mega dose steroids in traumatic brain injury. This study     was the largest randomized study that evaluated steroids in patients with traumatic brain     injury and was stopped early due to the significantly increased risk of death in patients     that received mega dose steroids at their 6-month follow-up when compared with the placebo     group (25.7% vs 22.3%; Relative Risk 1.15 Confidence Interval 1.07 to 1.24; p=0.0001).     Although the etiology of the increased risk of death was not determined, the findings of this     study should be taken into consideration when managing cases of TON with concurrent traumatic     brain injury. Very recently it has been shown the cytokine hormone erythropoietin (EPO) that     had been long known and used as a valuable agent to promote hematopoiesis has been protective     in experimental models of mechanical trauma, neuroinflammation, cerebral and retinal     ischemia, and even in a human stroke trial, and most notably in optic nerve transection. A     double blind placebo-controlled multicenter trial on EPO add-on treatment in chronic     schizophrenic men was performed. Treatment over 12 weeks with high-dose weekly (40,000 IU     intravenously) EPO led to significant improvement of cognitive performance compared to     placebo controls. Different studies have been performed on the effect of EPO on neuropathy in     different studies. The investigators recently published our results on treating patients with     TON with EPO and found it safe and effective. Patients were compared with a historical     control group of patients who received no treatment for TON. A better visual recovery was     found. The aim of this study is to determine the effectiveness of EPO on TON in a Multi-     center clinical trial using a semi-experimental design.   "
114751|NCT01783834|"     To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for     patients with previous treated non-small cell lung cancer   "
114752|NCT01783821|"     This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent     pulmonary injury when administered early in hospital course to the patients at risk for     developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for     budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD),     but the use of these two drugs is experimental for ARDS.   "
114753|NCT01783808|"     The purpose of this trial is to study the effects on exercise capacity, physical activity,     inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during     physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a     six-min walk test.      Our hypothesis is that if patients are able to use supplemental oxygen they will be more     physically active and thereby improve health related quality of life.   "
114754|NCT01783795|"     This study will help the investigator determine whether certain genetic mutations, more than     others, are a cause of more severe disease in Dent Disease.   "
114755|NCT01783782|"     The primary aim of this prospective, randomized and controlled study was to evaluate the     effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population.     The secondary endpoints were to evaluate the safety and the effects of preparation on     diagnostic yield of CE.   "
114756|NCT01783769|"     All eligible patients who will have neurosurgery at Barrow Neurological Institute (BNI)     between March 1, 2013 and February 28, 2014 will be enrolled as part of this study that will     look at the flow of staff people in and out of the operating room during surgeries and the     effect that the number of people may have on the rate of infections in the surgical sites.   "
114757|NCT01783756|"     This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of     lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast     cancer with metastases in the brain who have progressed on trastuzumab.      The combination of 2 drugs able to reach the brain (lapatinib and everolimus) that target     different parts of the HER2 signaling pathway plus chemotherapy (capecitabine) that has     proven benefits in metastatic breast cancer may lead to improved clinical outcomes for     participants with CNS metastasis.      Participants will undergo brain MRIs and CT scans of the chest and abdomen to evaluate     response to the treatment, regular laboratory tests and echocardiogram or Multi Gated     Acquisition Scan (MUGA) to assess cardiac activity   "
114758|NCT01783743|"     To achieve the goal of trachoma control as mandated by the World Health Organization,     countries must reduce the backlog of trichiasis surgery cases to less than 1/1,000 of their     population. However, these cases reside in rural villages in trachoma endemic districts, and     finding them to offer services is a challenge. Community Treatment Assistants (CTAs) are     village residents who are trained to offer Mass Drug Administration (MDA) to their     communities, and hence are in contact with most residents. A training guide and tool for     screening for trachomatous trichiasis (TT) will be developed to train CTAs in rural Tanzania     to identify cases in their communities and refer them to surgery. Compared to the current     process by which CTAs passively screen for TT if cases complain, investigators hypothesize     that the trained CTAs will identify twice the usual number of TT surgery cases during ongoing     community antibiotic administrations for trachoma and will also miss fewer cases. If this     simple system is effective, it can be implemented widely to screen communities for cases of     TT.      Thirty-six villages, for which a complete census is available, will be randomized on a 1:1     basis to intervention (where the CTAs receive the enhanced training from the enhanced     training team) and usual assessment (where the CTAs receive the usual instructions from the     regular MDA team). In both sets of villages the CTAs will keep records of all cases they have     screened as positive for TT.      A Master TT grader will grade all screened cases of TT to determine the rate of true     positivity. In addition, he will examine a random sample of residents who are screened as     negative to detect potentially missed cases and estimate the total burden of trichiasis     cases. The assessments of the Master TT grader will serve as the gold standard for     calculations of sensitivity, specificity, and positive and negative predictive values of the     enhanced training versus usual assessment methods.   "
114759|NCT01783730|"     This study was conducted to examine the safety profile and the effectiveness in daily     clinical practice of adalimumab in rheumatoid arthritis participants showing rapid     progression of structural damage of the joints, who had no prior history of treatment with     disease-modifying anti-rheumatic drugs or biological agents.   "
114760|NCT01783717|"     The purpose of this study is to examine the effect of exenatide on body weight and glycemic     control in subjects with obesity and/or diabetes mellitus due to hypothalamic damage.   "
115007|NCT01780506|"     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir     alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)     FDC in HIV-1 positive, antiretroviral treatment-naive adults.   "
114761|NCT01783704|"     Hip fracture is a common problem among older individuals. This year in the United States     approximately 350,000 people aged 65 and older will break a hip. Despite improvements in     therapy, hip fracture can still result in decreases in the strength of bone and muscle,     making it difficult to walk and perform daily activities.      Activity and exercise are believed to be of benefit for reducing disability in older adults,     yet the majority of older adults do not participate in regular exercise and is not active.     This is especially true for older adults following hip fracture after they complete the usual     rehabilitation program.      This study is being done to compare two 16-week supervised multi-part physical therapy     programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want     to test whether the interventions lead to improvements in a person's ability to walk on their     own in the home and in the local community. With this knowledge the investigators hope to     help a greater number of hip fracture patients enjoy a more complete recovery and improved     overall health.   "
114762|NCT01783691|"     The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics     of NKTT120 in adult patients with stable sickle cell disease.   "
114763|NCT01783678|"     This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV     infection who are co-infected with HIV-1.   "
114764|NCT01783665|"     In addition to the typical motor and sensory impairments, individuals with multiple sclerosis     (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive impairment     occurs in 40 % - 70% of patients with MS. In addition, sleep problems in individuals with MS     are very common, and approximately 50% of patients with MS have a diagnosable sleep disorder.     The research believes that aerobic exercise improve cognitive function and improve sleep     quality.   "
114765|NCT01783652|"     Objectives :      The key objective of this study is to develop new interventions that addresses the diverse     needs and circumstances of Hong Kong adolescents with depressive symptoms in community     settings. Collaboration between medical professionals and social workers may prevent the     occurrence of depression and misguided attempts to self-treat with alcohol and / or drugs in     our adolescents.      Methods :      To address this intervention gap in the United States, Dr. Van Voorhees, a research     collaborator of Dr. Chim and Dr. Ip, developed and conducted a phase 2 clinical trial of a     primary care internet-based depression prevention intervention (CATCH-IT, Competent Adulthood     Transition with Cognitive Behavioral Humanistic and Interpersonal training). It has been     observed clinically that the strategy could reduce depressed mood, increased social support     and reduced depressive episodes at 12 month follow-up.      The investigators now propose to study if an adaptation of the CATCH-IT website for Hong Kong     Chinese adolescents may lead to significant reductions in depressed mood. In this pilot     trial, the investigators propose to test the efficacy of the Adapted and Translated version     of CATCH-IT (AT-CATCH) against the placebo approach in preventing the onset of depressive     episodes in a group of adolescents (aged 13-17) who have depressive symptoms, but have not     developed depression yet.The case group will have access to the AT-CATCH website while the     control group will only be allow to use the anti-smoking website.      The investigators hypothesize that compared to youth in the control group, youth assigned to     the AT-CATCH group will have a lower hazard ratio of major depressive episodes and decreased     alcohol / drug use frequency over 2 years. Moreover, compared to youth in the control group,     youth in the AT-CATCH program will demonstrate a steeper slope of improved symptoms through     growth curve analysis and fewer depressed days over the study period.   "
114766|NCT01783639|"     The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients     undergoing carotid artery stenting to a performance goal based on an analysis of the results     of previous US IDE carotid stenting with embolic protection studies   "
114767|NCT01783626|"     Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with     respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes     configurations are proposed (3 versions in total), with the objective to modulate the     hemodialyzer removal capacities (convective and adsorptive capacities).      Materials(including heparin grafted specifications) as well as the sterilization process are     identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study     is requested to document in vivo the different prototypes removal capacities with respect to     middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with     regards to protein loss.   "
114768|NCT01783613|"     Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR.     Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is     increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all     these alterations stimulated a chronic and bad regulated state of inflammation. For this     porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in     patients elder than two months old and randomized to received every day a dietetically     supplement with DHA or placebo, will be done during 12 months. The trial has as a principal     objective to proved if this long term supplementation could decrease in contrast with     placebo.   "
114769|NCT01783600|"     The objective of this clinical evaluation is to evaluate the immediate and long-term (up to     12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective,     non-randomised, controlled investigation for the treatment of patients with critical limb     ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the     level of the below-the-knee arteries.   "
114770|NCT01783587|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational drug. Phase I studies also try to define the appropriate dose of the     investigational drug to use for further studies. Investigational means that the drug is     still being studied and that research doctors are trying to find out more about it-such as     the safest dose to use and the side effects it may cause.      Afatinib has been studied in other clinical trials of participants with head and neck cancer,     lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research     studies. This is the first clinical trial to study Afatinib in combination with Radiation     Therapy.      The purpose of this study is to determine the safest dose of Afatinib when given in     combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy     for head and neck cancer.      Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by     blocking multiple proteins known to play a role in the growth of cancer cells. Information     from laboratory research studies suggests that this drug may help to make head and neck     cancer cells more sensitive to Radiation Therapy.      The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a     chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the     standard treatment if you have high risk disease. High risk disease means that without     additional therapy, there is a high risk that the disease may return. In this study,     participants with high-risk disease will receive Radiation Therapy and Docetaxel and     Afatinib. Intermediate risk means that there is an intermediate risk that the disease may     return. Radiation Therapy alone is the standard treatment approach for intermediate risk     cancer. In this study, participants with intermediate risk disease will receive Radiation     Therapy and Afatinib.   "
114771|NCT01783574|"     The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive     symptoms in women with Major Depressive Disorder (MDD) and antidepressant     partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women     with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation     improves fatigue and sexual dysfunction.   "
115008|NCT01780493|"     To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy     technique.   "
130450|NCT01577511|"     The main objective of this study is to identify and characterize subpopulations of cells with     invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.   "
114772|NCT01783561|"     Premature infants are at risk of having pauses in breathing, or apneas, due to their     immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the     first day of life to prevent apneas. However, if they continue to have apneas, they may     require a breathing tube to be placed in the trachea. There are risks to having a breathing     tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may     decrease the need for a breathing tube. Some studies also suggest that caffeine may also     improve heart function which may prevent low blood pressure if given early.   "
114773|NCT01783548|"     The purpose of this study is to evaluate the efficacy and safety of Beclomethasone     dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).   "
114774|NCT01783535|"     The primary objective of this protocol is to evaluate the response rate of bilateral disease     participants who have at least one eye with advanced intra-ocular retinoblastoma (stratum B)     using upfront therapy with chemotherapy delivered directly to the eye. The main biology     objective is to improve our understanding of the biology and tumorigenesis (how tumor     develops) of retinoblastoma when biology specimens are available. As clinicians, the primary     goal of the investigators for children with retinoblastoma is to provide optimal therapy     using multiple treatment approaches [chemotherapy (into the vein and directly into membrane     of eyeball), cryotherapy (freeze and destroy tumor), thermotherapy (laser or heat to destroy     tumor), radiation therapy, and surgical removal of eye if needed) in an attempt to preserve     the eye and vision whenever possible, while still curing the disease. Therefore, all children     with non-metastatic retinoblastoma at St. Jude will be offered enrollment on this study.      PRIMARY OBJECTIVE:        -  To evaluate the response (complete + partial response) rate of bilateral disease          participants who have at least one eye with advanced intraocular retinoblastoma (Stratum          B) to two upfront courses of therapy consisting of subconjunctival carboplatin and          systemic topotecan.      SECONDARY OBJECTIVES:        -  To evaluate the ocular survival of eyes and event-free survival of participants by          strata.        -  To prospectively analyze intraocular disease tissue for participants with at least one          eye undergoing enucleation in order to identify the mechanism of RB1 bi-allelic          inactivation. Participants may undergo upfront enucleation (due to advanced disease at          diagnosis) or may receive enucleation due to progressive disease during protocol          therapy.   "
114775|NCT01783522|"     This randomized phase II trial studies glutamine in preventing peripheral neuropathy in     patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent     peripheral neuropathy in patients receiving chemotherapy   "
114776|NCT01783509|"     The purpose of this study is to understand more about limb-girdle muscular dystrophy.     Therefore, the investigators would like to track the following information collected once a     year from patients with GENETICALLY CONFIRMED LGMD: quality of life questionnaires, muscle     strength, motor function, routine examination, assessment of patient (or parent)     understanding of LGMD, and serum (blood) for growth factors, cytokines, and biomarkers (all     parts of your blood). By tracking this information, we hope to be able to understand more     about the diagnosis, progression and natural history of this disorder.   "
114777|NCT01783496|"     The purpose of this study to evaluate treatment with the Thermage CPT system for facial and     neck laxity.   "
114778|NCT01783483|"     The primary objective of this study is to evaluate sternal bone healing following a full     median sternotomy versus standard of care for sternal closure with wire cerclage. Additional     outcomes on post-operative pain and analgesic usage, patient function and quality of life,     and complications will also be collected. A health economics study will also be conducted, in     which cost and billing data will be collected from sites participating in this clinical     study.   "
114779|NCT01783470|"     This study will test the hypothesis that human brown adipose tissue (BAT) can be activated     using a β3-adrenergic receptor (AR) agonist. The efficacy of β3-AR agonist will be compared     with cold exposure, which we have already shown can activate human BAT, as well as a placebo     control.   "
114780|NCT01783457|"     Treatment delay in psychosis usually lead to slower recovery, an increase in associated     comorbidity and greater deterioration in social and family life of patients. Previous studies     indicate that an early intervention with guidelines for increasing adherence to treatment,     disease awareness and condition management leads to better progression of the disorder and is     therefore related to a better prognosis.      Several studies have found that the rate of relapse is higher in patients with     pharmacological treatment alone compared to those also receiving psychoeducation, who tend to     improve their adherence to treatment and reduce toxic drugs dosage.      Hypotheses:        -  Individual psychoeducation will be effective as complementary therapy to pharmacological          treatment in patients with a first psychotic episode, improving disease evolution.        -  BDNF levels will increase more in the patients receiving individual therapy compared to          those without it.        -  Psychoeducation can be performed similarly in all participating centers if the          therapists receive the same training and use the same psychoeducation material.        -  The use of telemedicine for the follow-up of the patients will help improve the welfare          work and therefore the disease evolution.   "
114781|NCT01783444|"     This study will assess the efficacy and tolerability of everolimus and capecitabine     monotherapies compared to everolimus/exemestane combination in woman with ER + advanced     breast cancer.   "
114782|NCT01783431|"     This study is for subjects with a type of skin cancer called melanoma. The main purpose of     this study is to examine the safety of the study drug (Poly-ICLC) in patients with your     disease. The study team would like to know about any side effects a patient may have when     given the study drug. Another goal of the study is to determine if combining dendritic cells     and the study drug can be possibly used as a vaccine for your disease.   "
114783|NCT01783418|"     The purpose of this study is to evaluate the effects of a mindfulness-based meditation     intervention on quality of life, sleep and mood in adolescents with cancer compared to a     control group.   "
114784|NCT01783405|"     The objective of this project is to establish the current prevalence of cardiovascular     disease in adult subjects suffering from genetically diagnosed HF, and to know the impact     that drug treatment has course in cardiovascular disease when compared with that of their     affected parents with a much longer period of exposure to hypercholesterolemia   "
114786|NCT01783379|"     In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected     cohort of patients with suspected or proven invasive fungal infections. Patients will receive     micafungin for the period necessary to achieve clinical and / or mycological cure. An attempt     will be made to have 2 PK curves, one full and one limited sampling on days 3 (n=9) and 7     (n=5). Furthermore, we will be able to determine intra-individual variability. On non-PK     days, trough samples will be taken to determine the time to steady state. All samples will be     taken just prior to the morning dose of micafungin. All infusion rates will be according to     the SPC label information. Patients are considered to be evaluable if at least the first PK     curve has been completed. Two moments of PK analysis will enable us to determine whether     there is an increase over time in exposure if steady state has not been reached.   "
114787|NCT01783366|"     we first examined whether use of tube exchange catheter during NGT insertion could increase     the success rate on the first attempt of NGT insertion compared with conventional technique.     We then addressed the question of whether the use of tube exchange catheter might decrease     the possible occurrence of complication associated with YOON insertion.   "
114788|NCT01783353|"     Up to one-third of common warts can remain recalcitrant, an occurrence that has been     attributed to impaired cell-mediated immunity. At present, no guidelines exist for the     management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent,     has shown promise in this regard. Previous studies documenting the efficacy of oral zinc used     zinc sulfate given at a maximum dose of 600 mg/day, equivalent to 140 mg of elemental zinc,     which is over three times the recommended upper limit of 40 mg of elemental zinc per day.     This raises concerns over safety and tolerability. In the Philippines, oral zinc is more     widely available in chelated forms such as zinc gluconate, which have the benefit of improved     absorption compared to non-chelated compounds such as zinc sulfate. This study will seek to     determine if zinc gluconate 300 mg/day, equivalent to 40 mg of elemental zinc, will be     efficacious in treating recalcitrant cutaneous warts. This lowered dose may have the added     benefits of increased safety, tolerability, and cost-effectiveness.   "
114789|NCT01783340|"     This study will assess the superior protective immunity of the combination of chloroquine and     azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a     standard chloroquine prophylactic regimen.   "
114790|NCT01783327|"     The purpose of this study is to evaluate the use of a state-of the art internet     psycho-educational program in clinical practice (Teens-Connect), compared to use of a     standard and widely available internet diabetes program for youth (Planet D™) in a     mixed-method randomized clinical trial design.   "
114791|NCT01783314|"     When someone has hepatitis C or some other condition that causes liver injury, he or she can     develop a condition called liver fibrosis that over time, can cause the liver to stop working     normally. Currently, the best way to determine the degree of fibrosis is to do a liver     biopsy. The investigators hope to show that measuring the degree of liver fibrosis using an     MRI with gadoxetate disodium is as good as or better than obtaining this information by     performing a liver biopsy. Gadoxetate disodium is a contrast solution given through the veins     that is considered safe, is approved for use by the Food and Drug Administration, and is     already routinely given to patients with various forms of liver disease, including fibrosis.   "
114792|NCT01783301|"     The overall objectives of this trial are to:        -  To explore the efficacy and safety of using either antral follicle count (AFC) or          anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian          stimulation for Assisted Reproductive Technology (ART).        -  To assess the differences in both ovarian response and clinical pregnancy rate between          subjects with different AFC and AMH levels undergoing ART.   "
114793|NCT01783288|"     The purpose of the study is to determine whether patients meet criteria for Postural     Tachycardia Syndrome (or not) and have reduced blood volume (or not). Both of these are     important screening elements to Aim 3 of a National Institutes of Health Grant. The purposes     of Aim 3 are to determine 1. whether a high dietary sodium level appropriately expands plasma     volume in Postural Orthostatic Tachycardia, 2. whether plasma renin activity and aldosterone     are modified appropriately by changes in dietary sodium in Postural Tachycardia Syndrome and     3. whether patients with Postural Tachycardia Syndrome have improvements in their orthostatic     tachycardia and symptoms as a result of a high dietary sodium level.   "
114794|NCT01783275|"     It is known that obesity and/or physical inactivity greatly increase a person's risk of     developing heart disease and other serious health problems. This is partly because diabetes     is associated with inflammation, oxidative stress, and insulin resistance. Diabetes is also     associated with high levels of triglycerides in the blood and tissues such as the liver     (known as fatty liver or steatosis). This elevation of fat in the liver is known to cause     liver insulin resistance and impair the function of the liver and this impairment contributes     to the development of diabetes.      Studies have shown that both aerobic exercise and weight loss have beneficial results on     insulin resistance. However, the cause of this benefit remains unclear. We know that both     aerobic exercise and/or weight loss can improve how muscle responds to insulin. However, it     is also known that aerobic exercise and/or weight loss lowers liver fat content, thereby     making it possible that the liver's response to insulin is also improved by weight loss     and/or exercise training. An improved responsiveness of the liver to insulin could lower     blood sugar levels after a meal and it could also lower morning blood sugar levels. However,     very little is known about how exercise and/or weight loss improves liver function in people     with type 2 diabetes.      Hypothesis 1: Improved hepatic insulin sensitivity, as a result of either exercise training     or weight loss, will increase the amount of glucose from an oral load that is taken up by the     liver in subjects with DM. We also hypothesize that the amount of glucose taken up by the     liver will be increased even further in response to exercise training plus weight loss     compared to either treatment alone.      Hypothesis 2: Increases in hepatic insulin sensitivity as a result of exercise with weight     loss will cause reductions in EGP during the fasted state, and will improve the suppression     of EGP seen in response to hyperinsulinemia.   "
114795|NCT01783262|"     Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in     patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.   "
114796|NCT01783249|"     That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and     hematopoietic stem and progenitor cell mitochondrial function.   "
114808|NCT01783093|"     The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell     disease who have had multiple echocardiograms. Previous studies have shown that an elevated     tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of     mortality. This initial data only examined an isolated TR jet velocity. It was presumed that     the mortality was related to pulmonary hypertension.      It is the aim of this study to retrospectively evaluate patients who have had multiple     echocardiograms and to determine if patients who had either a normalization of their TR jet     velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart     catheterization had a similar mortality rate to those with persistently elevated TR jet     velocity.   "
114797|NCT01783236|"     We will study the efficacy of FDA approved intravenous (IV) acetaminophen (Ofirmev, © 2011     Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive     thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to     reduce the need for patient controlled analgesia and the total dose of opioids, which have     serious side effects in thoracic surgery patients. We will compare the use of IV     patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain.     We will determine if IV acetaminophen reduces post-operative morphine requirements (primary     end point). We will also assess subject pain scores and post-operative complications     associated with pain management as secondary end points. Our hypothesis is that the study arm     receiving intravenous acetaminophen will have lower total morphine consumptions compared to     the placebo group.   "
114798|NCT01783223|"     This study is intended to evaluate the prevalence of chronically inebriated patients in the     Emergeny Department (ED). Patients will be identified prospectively by screening all patients     (24/7) presenting to the ED for one month. A running tally of all patients in the ED will be     kept. Of these patients, any patient that is noted to have alcohol intoxication will be     identified. The chart of that patient will be reviewed for details about the patient's     alcohol use and for the patient's suitability for a sobering house, which is a place where     intoxicated patients can go to await sobriety. The chart will also be reviewed for the number     of previous visits for alcohol use to our hospital ever and in the last year.   "
114799|NCT01783210|"     The investigators evaluate if changing eating habits and introducing a correct lifestyle in     women with BMI >25 Kg/m2 would improve unfavorable maternal-fetal outcomes associated with     excessive weight gain (EWG) during pregnancy. To pursue these goals, eligible women are     randomly assigned to no intervention (Control group) that receive only a simple nutritional     booklet about lifestyle and healthy diet during pregnancy without explicit caloric     restriction or the Therapeutic Lifestyle Changes Program (TLC group) that receive a caloric     restriction (1500 Kcal/day divided in3 main meals and 3 snacks + 300 kcal/die for overweight     or 200 kcal/die for obese women submitted to energy expenditure program) associated to a mild     physical activity (30 minutes at least 3 days/week) The investigators use a tool that could     easily and practically evaluate not only total GWG at term, but also changes in maternal body     composition: the bioimpedance analyzer.   "
114800|NCT01783197|"     This research is being done because further research on selumetinib in combination with     standard chemotherapy treatment is needed. Although the number of treatment options for     patients with advanced non-small cell lung cancer has increased over the past decade,     prognosis remains poor, and there is a need for additional therapeutic options.   "
114801|NCT01783184|"     The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is     the subject of this observational study. 180 patients will be implanted with the Anaconda™     Stent Graft System and will be followed-up annually for 5 years post-implant. The study will     satisfy the requirements of the French National Authority for Health (Haute Autorité de     santé) and the data collected will be used for reimbursement renewal.   "
114802|NCT01783171|"     This randomized phase I trial studies the side effects and best dose of dinaciclib and Akt     inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by     surgery. Dinaciclib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
114803|NCT01783158|"     Patients with HNSCC represent a high-risk group for the development of SESCC. Thus,     esophagogastrofibroscopy should be performed to detect possible synchronous esophageal     carcinomas in these patients.      Although only two patients with synchronous primary carcinomas were found among the patients     with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced     endoscopic methods should be recommended after detection of HNSCC to exclude secondary     esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy     and inexpensive option and can be done in most of gastroenterology offices.   "
114804|NCT01783145|"     The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP)     to follow-up patients with metastatic testicular cancer after completion of chemotherapy that     resulted in complete remission.   "
114805|NCT01783132|"     To compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ICS)     controller treatment guided by exhaled NO measurement made at home with usual care asthma     management with regard to asthma control (primary outcome), asthma-related quality of life,     lung function, airway inflammation, medication use, and asthma events.      To understand changes in patient behaviour triggered by daily FENO measurement at home, for     example treatment adherence and voluntary allergen exposure.   "
114806|NCT01783119|"     The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel     Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional     treatment can have adverse effects and does not guarantee effectiveness in some patients     requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a     beneficial effect in different disease, and have an anti-inflammatory effect in UC patients.     Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a     period of three months, in the degree of inflammation in patients with mild UC based on Mayo     scale and quantification of IL-6 in the colonic mucosa.   "
114807|NCT01783106|"     There is growing evidence that Crohn's disease may be caused by replication of bacteria,     perhaps particularly E. coli, within macrophages (a specialized sort of white blood cell).     Laboratory studies show that a combination of antibiotics that can penetrate macrophages     (such as ciprofloxacin and doxycycline) together with the anti-malarial drug     hydroxychloroquine (which makes the contents of macrophage vesicles more alkaline and helps     them to kill intracellular bacteria) is particularly effective at killing the E. coli within     macrophages.   "
114809|NCT01783080|"     The investigators aimed to assess the ability of a modified version of Behavioral Activation     for occupational and social improvement to produce change in: 1. social adjustment, 2. work     functioning, 3. avoidance behavior and 4. behavioral activation.   "
115009|NCT01780480|"     To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula     (Fangji) based on differentiation of syndromes (Zhenghou) according to the theory of     traditional Chinese medicine for improving the symptoms in the convalescent phase of ischemic     stroke, and to establish the pharmacodynamic model of Zhenghou according to the results of     this trial.   "
114810|NCT01783067|"     Populations who consume non-fortified plant-based diets are at increased risk of iron and     zinc deficiencies. The purpose of this randomized controlled study is to determine the     absorption of iron and zinc from pearl millet biofortified with these two micronutrients.     Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl     millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron     absorbed are measured with established stable isotope extrinsic labeling techniques and     analyses of duplicate diets.   "
114811|NCT01783054|"     This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this     research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and     Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will     have screening tests to determine if he or she is eligible to participate in this study.   "
114812|NCT01783041|"     Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early     growth which places them at increased risk for developmental problems later in life. The     micronutrient carnitine, which is present in breast milk and stored in the fetus late in     pregnancy, has been shown to protect against brain injury in animal studies. Without     supplementation, almost all preterm infants develop carnitine deficiency soon after birth.     Thus it is important to determine if carnitine supplementation protects against brain injury     and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that     preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will     not develop carnitine deficiency and will have improved growth in the first two weeks of life     and higher scores on developmental tests when compared to control infants who did not receive     carnitine.   "
114813|NCT01783028|"     This study tests the hypothesis that community health workers providing home visits to     provide education and support for self-management of asthma, assessment of the home for     environmental triggers, resources for asthma control, and assistance in effective     communication with medical providers over the course of one year would reduce asthma     morbidity, asthma-related urgent health care use and exposure to indoor asthma triggers among     low income adults with not well controlled asthma.   "
114814|NCT01783015|"     The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to     placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or     adalimumab plus methotrexate. This comparison will be performed for all subjects and     separately for subjects who are anti-drug antibody positive for one of these medications.     From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect     of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of     etanercept in these subjects will also be evaluated throughout the study.   "
114815|NCT01783002|"     The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and     conventional SPECT-CT for the detection of abnormal parathyroid glands.   "
114816|NCT01782989|"     This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the     treatment of geographic atrophy due to dry age-related macular degeneration (AMD).   "
114817|NCT01782976|"     The goal of this clinical research study is to learn if cilengitide given in combination with     bevacizumab can help to control glioblastoma. The safety of this drug combination will also     be studied.      Cilengitide is designed to block the flow of blood to cancer cells, which may help to slow or     block the growth of cancer.      Bevacizumab is designed to block the growth of new blood vessels, which may help to slow or     block the growth of cancer.   "
114818|NCT01782963|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational combination of drugs. The purpose is to learn whether the     combination of drugs works in treating a specific cancer. Investigational means that the     combination of drugs is still being studied. It also means that research doctors are trying     to find out more about it. Examples of what they want to learn about are the safest dose to     use, the side effects it may cause, and if the combination of drugs works for treating     different types of cancer.   "
114819|NCT01782950|"     Tuberculosis (TB) is a leading cause of death in HIV-infected individuals. There are     insufficient data correlating concentrations of anti-TB drugs with treatment response. We     hypothesize that sub-therapeutic concentrations of anti-TB drugs are associated with     inadequate TB treatment response to Mycobacterium tuberculosis.   "
114820|NCT01782937|"     This study is an open-label, non-controlled study to evaluate the efficacy and safety of     KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma.     Pharmacokinetics of KHK4827 will also be assessed.   "
114821|NCT01782924|"     This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in     subjects with moderate to severe plaque psoriasis who have completed the preceding Study     4827-002.   "
114822|NCT01782911|"     Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity     and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin     resistance with resulting hyperinsulinemia is also common among women with PCOS, along with     increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular     consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative     and pro-apoptotic properties, that has been shown to decrease proliferation and     steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients.     However, little is known about its potential beneficial effect on oocyte quality as well as     other reproductive outcomes, such as implantation an pregnancy rates. The present study     evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome     among patients with PCOS who undergo in vitro fertilization (IVF).   "
114843|NCT01782638|"     Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved     gait in parkinsonian patients. However, sometimes the investigators observed a gait     aggravation either with using high voltage and high frequencies, either because of suboptimal     placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this     gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a     diffusion of the electric stimulation current to the fibbers going near STN area.      The primary purpose of this study is to compare the effect of deep brain stimulation with     high frequency versus low frequency on gait of patients whatever the electrodes placement     (STN ou Forel fields) and whatever the medication condition (with or without treatment).   "
114823|NCT01782898|"     Seventy percent of surgeries performed in the United States are done in an outpatient     setting.Pain Control after ambulatory surgery is very challenging because patients do not     have access to fast and potent intravenous medications Pain after ambulatory surgery is     poorly controlled in the United States with up to seventy five percent of patients having     moderate to severe pain after ambulatory procedures. Postoperative pain have been associated     with serious morbidity, including myocardial infarction and pulmonary embolism.      The use of intraoperative opioids can result in an exaggerated response to pain     (hyperalgesia) and contribute to an exacerbation of pain after surgical procedures.Opioids     are commonly given intraoperative, not in response to pain, but in response to hyperdynamic     cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to     treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown to     have central antihyperalgesic effects that might contribute to a reduction in postoperative     pain. It is therefore conceivable that the use of intraoperative esmolol instead of opioids     to avoid hyperdynamic states during surgery can result in lower postoperative pain. Since     postoperative pain can substantially affect postoperative quality of recovery, it is also     conceivable that the use of intraoperative esmolol might result in an improved postoperative     quality of recovery to surgical patients.      The main objective of the current study is to examine the effect of intraoperative esmolol on     postoperative quality of recovery. A secondary objective is to examine the effect of esmolol     on postoperative pain.      Significance: Postoperative pain after ambulatory surgery has been shown to be poorly managed     in The United States. The goal of this study is to investigate if a change in the     intraoperative pharmacologic management of patients undergoing ambulatory surgery can improve     their postoperative quality of recovery and pain.      The research question is; does the use of intraoperative esmolol improve postoperative     quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve     postoperative pain after ambulatory surgery?      The hypotheses of this study is; does the use of intraoperative esmolol improves     postoperative quality of recovery after ambulatory surgery. The use of intraoperative esmolol     reduces postoperative pain after ambulatory surgery.   "
114824|NCT01782885|"     The purpose of this study is to test whether the platelet-rich plasma (PRP) intra-articular     injection therapy is effective as an alternative treatment option in patients with mild knee     osteoarthritis within a controlled randomized study compared to first line treatment     acetaminophen. The investigators will evaluate patients outcome in level of pain, knee     function and quality of life before the treatment and at 6, 12 and 24 weeks follow up.      The study will be complemented with in vitro experiments of human osteoarthritic cartilage     explants culture (treated with PRP) for histological and gene expression assays.      PRP intra-articular injections therapy is effective in patients with mild knee osteoarthritis     by modifying the biochemical joint environment and cartilage regeneration capability.   "
114825|NCT01782872|"     The purpose of this study is to determine which medication(s) should be included in the     interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in     the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The     ideal nerve block would reduce pain after shoulder surgery without causing a great deal of     muscle weakness.   "
114826|NCT01782859|"     Studies have shown that surgery causes some reactions in your body consistent with     inflammation. When the inflammation is extensive, it may affect different parts of the body     including the lungs. Corticosteroids are commonly used to treat inflammation and are     different from performance enhancing steroids associated with athletics. The purpose of this     study is to determine the influence of low dose steroids given 3 times in a 24 hour period on     thrombotic markers (markers that are associated with increased risks of clotting, a possible     complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response     seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized     placebo controlled trial patients undergoing total hip replacement.   "
114827|NCT01782846|"     Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®,     Dafalgan-Codeine®) in the emergency unit.      The efficacy (relief of pain) would be assessed 2 hours after administration of one of the     two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain     assessment score).   "
114828|NCT01782833|"     This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this     study is observational in nature to collect the safety data after administrating the Pletaal     SR capsule, from baseline to 16 weeks.   "
114829|NCT01782820|"     The aim of the present study is to compare the time course of a neuromuscular block in     patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting     several hours before surgery with patients receiving the drug immediately before induction of     anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is the     time from start of injection of rocuronium until recovery to a train of four ratio (TOF     ratio) of 0.9.   "
114830|NCT01782807|"     The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been     controversial. studies have shown conflicting data regarding ovarian function after simple     Hysterectomy.      In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have     preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the     consequences regarding ovarian function have yet to be established.      The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs.     Hysterectomy combined with salpingectomy or fimbriectomy   "
114831|NCT01782794|"     The present study is conducted in order to assess the acceptability of Hepatitis B     vaccination in French general population before and after reimbursement of the paediatric     vaccine InfanrixHexa. Four measurements are planned, first before reimbursement and the     others at year 1, 2 and 3 after reimbursement.   "
114832|NCT01782781|"     The aim of the study is to evaluate traditional analgesic therapy after abdominal     hysterectomy with single infiltration of local anesthetics in the surgical area at the end of     surgery.   "
114833|NCT01782768|"     Background: The efﬁciency of Neural respiratory drive (NRD)expressed by a ratio of     ventilation to the diaphragm electromyogram (EMGdi) decreases in patients with COPD     .Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical     symptom and make the patients feel comfort.Noninvasive positive pressure ventilation(NPPV)is     a good treatment to AECOPD patients.It is unknown the effects of different mode of     noninvasive positive pressure ventilation(NPPV) such as proportional assist ventilation (PAV)     and pressure-support ventilation (PSV) on the efﬁciency of Neural drive of AECOPD and which     mode benefit the patients more.      Objective: To compare the short-term effects of mask pressure support ventilation (PSV) and     proportional assist ventilation (PAV) on Neural respiratory drive in recovering patients of     AECOPD   "
114844|NCT01782625|"     The investigators will simulate the conditions of a working, helmeted diver by using     exercising, head out immersed subjects to test the following hypotheses:        1. An algorithm can be developed which predicts cognitive performance in immersed          exercising divers, based on the exhaled carbon dioxide (PETCO2) and the diver's inspired          partial pressures of oxygen and nitrogen (PIO2 and PIN2).        2. PETCO2 using mass spectrometry is an accurate estimate of arterial carbon dioxide          (PaCO2) at rest and during immersed exercise and can be used as a PaCO2 surrogate at          levels exceeding 50 mmHg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165          fsw density of 6.8 g/l).   "
114834|NCT01782755|"     Probiotics are commercially available live bacteria thought to have health benefits when     ingested. A literature review of probiotic studies in the intensive care unit (ICU) found     that in patients who receive probiotics, there is a 25% reduction in lung infection, known as     ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of     developing any infection in the ICU. However, the studies reviewed were small and not well     done. Therefore, whether probiotics are really helpful or not is unclear. Before a large     carefully performed study is done to evaluate the effects of probiotics in critically ill     patients, a pilot trial is needed. The investigators plan to study the feasibility of such a     trial in mechanically ventilated ICU patients in 11 ICUs in Ontario, investigating whether     orally ingested L. rhamnosus GG (a common probiotic) prevents VAP and other infections. The 4     goals of the pilot study will be to ensure that we can successfully enrol patients; follow     the protocol faithfully; make sure patients don't receive additional probiotics, and estimate     how much pneumonia exists in these patients. In a separate substudy, the investigators will     evaluate the effects of probiotics on lower lung infiltration with potential harmful     bacteria, stool bacteria, markers of immunity called cytokines, and markers of infection     called endotoxin levels. The investigators plan to enroll 150 adults admitted to ICU and     receiving mechanical ventilation. Following informed consent, patients will be randomized to     either L. rhamnosus GG group or an identical placebo. Twice daily, patients will receive     probiotics or placebo in a feeding tube. The investigators will record all infections and     other important outcomes in the ICU. This study is very important in the ongoing search for     more effective strategies to prevent serious infection during critical illness. Probiotics     may be an easy-to-use, readily available, inexpensive approach to help future critically ill     patients around the world.   "
114835|NCT01782742|"     Retinoid X receptors (RXR) are nuclear receptors that have been linked to numerous metabolic     pathways relevant to Alzheimer's disease (AD) and Aβ (harmful protein) production and     removal. The study drug bexarotene is an FDA approved anti-cancer agent but is not approved     for use in Alzheimer's disease. Bexarotene acts as an RXR agonist that has reduced Aβ     (harmful protein) in the brain in experimental models of Alzheimer's disease.      This study aims to determine the safety and effect on abnormal proteins found in the brain     (based on brain scans) of 300 mg of bexarotene administered for one month compared to     placebo (inactive agent).   "
114836|NCT01782729|"     The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in     treating the signs and symptoms of moderate (medium level of seriousness) to severe (very     serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic     [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease     with a genetic predisposition [latent susceptibility to disease at the genetic level]) in     pediatric participants.   "
114837|NCT01782716|"     Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main     objectives of this study is to calculate mortality probability by two different risk score     system and to inquire effects of informing anesthesiologist and surgical team; of score of     the patient; on length of hospitalization and intensive care and also on actualized     mortality.   "
114838|NCT01782703|"     Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder     of children, affecting 10-20% of children and 1-2% of adults.      This skin disorder can be associated with unbearable itchiness and an increased     susceptibility to skin infections. The cause of AD is currently poorly understood; therefore,     there are no targeted treatment options at present. There have been recent studies in adults     with AD that explain the cause and give us new routes to investigate treatment options,     however no major studies in this arena have been done in children. We hope to evaluate the     skin and blood biomarkers that are found in pediatric AD and compare them to adult AD.      Hypothesis: The immune system worsens the skin barrier issues that are common in atopic     dermatitis. We believe there are similar immune and skin abnormalities in adult versus     pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic     dermatitis can serve as surrogates for skin immune activation and will correlate with disease     severity.   "
114839|NCT01782690|"     This observational study will evaluate the impact of rash on survival of patients with     metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcitabine. Further,     clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12     months.   "
114840|NCT01782677|"     The primary aim of the study is to determine safety, tolerability and feasibility of     bilateral carotid body resection in patients with systolic heart failure and peripheral     chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of     bilateral carotid body resection.   "
114841|NCT01782664|"     A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy     of GSK2586184 in patients with chronic plaque psoriasis.      There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this     part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects     will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg     GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of     400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184     concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will     take 400 mg GSK2586184.      In both Cohorts A and B, study medication will be administered orally (as tablets), twice     daily, for up to 12 weeks.      Each subject will have 7 out-patient visits: Screening; Baseline & Start of treatment; Week     2; Week 4; Week 8; Week 12; and Follow-up (Week 16)   "
114842|NCT01782651|"     This study will describe the treatment paradigm used over recent years in the clinical     management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in     Hungary. This information will provide insight into real-world exposure and adherence to     anti-HER2 therapy containing regimens, and improve understanding of the reasons for     discontinuation of this therapy.      This is a retrospective, descriptive, cohort study of approximately 180 female patients     diagnosed with HER2-positive metastatic breast cancer in Hungary. Patients diagnosed with, or     who progressed to, metastatic disease between 01 September 2009 and 01 September 2010 will be     included. All patients will be followed until death, loss to follow-up or the end of the     study period (30 September 2012). All data will be collected retrospectively from patient     medical records.      Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic     breast cancer patients, including sites of metastases, the time from initial breast cancer     diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of     HER2 will be described. Further, descriptive statistics of the proportion of HER2+ metastatic     breast cancer patients who received anti-HER2 therapy, the sequencing of different therapies,     and the duration of therapies in the metastatic setting will be analysed. Among the subset of     women who receive lapatinib plus capecitabine, descriptive statistics of the timing of     initiation of lapatinib plus capecitabine in the metastatic treatment pathway, time to     treatment discontinuation and time to progression (TTP) on lapatinib plus capecitabine will     be calculated. Further, descriptive statistics of the type and duration anti-HER2 therapies     used prior to initiation of lapatinib plus capecitabine and, where relevant, after     lapatinib+capecitabine will be performed.   "
114877|NCT01782196|"     Certain research and innovation projects require an assessment of the adhesive properties of     adhesives, which cannot be established from in-vitro testing. The most valuable data for     assessments of this type comes from adhesion and wear time studies involving application to     living human skin on volunteers. The purpose of the study is to assess the safety and     performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a     group of subjects with an ileostomy.   "
114845|NCT01782612|"     Postoperative recovery is always worrisome to the elder patients undergoing Total Hip     Replacement (THR). Peripheral Nerve Blocks (PNBs), lumbar plexus block combined with sciatic     nerve blocks, may be alterative anaesthesia style to the fragile patients. But pervious     papers suggested PNBs were commonly administered in conjunction with general anesthesia (GA),     or the blocks were performed primarily for postoperative analgesia. Hardly any research has     reported in use of Peripheral Nerve Blocks (PNBs) as primary anesthesia style for Total Hip     Replacement (THR). The investigators compare peripheral nerve blocks to general anesthesia on     elderly eld patients undergoing Total Hip Replacement (THR) by assessing the Postoperative     Recovery and Delirium   "
114846|NCT01782599|"     The purpose of this study is to determine whether electronic cigarettes can reduce reactivity     to smoking-related cues.   "
114847|NCT01782586|"     The purpose of this study is to determine if certain genes found in a kidney biopsy performed     at one-year post transplant can predict which transplanted kidneys will have decreased kidney     function within five years post-transplant.   "
114848|NCT01782573|"     To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more     effective on the reduction of surgical site microbial colonization and subsequent infection     than is normal saline.   "
114849|NCT01782560|"     Noisy breathing is commonly caused by a floppy voicebox which is a condition called     laryngomalacia. The cause of laryngomalacia is not fully understood, but some studies have     suggested that it could be due to acid escaping from the stomach and spreading up the     swallowing passage to the throat (acid reflux). This affects about 1 in 100 newborns and is     therefore one of the most common reasons for infants to see Otolaryngologists at BC     Children's Hospital (BCCH). These infants can have a spectrum of distressing symptoms     including squeaky breathing, choking, difficulty feeding, failure to gain weight, and     episodes of turning blue (due to lack of oxygen).      At present, Otolaryngologists at BCCH will sometimes give children with laryngomalacia     medication to reduce the amount of acid they make in their stomachs, in the hope that this     will reduce their symptoms of laryngomalacia. It has never been scientifically confirmed     whether anti-reflux medication will benefit these children any more than doing nothing at     all.   "
114850|NCT01782547|"     Hospitalization of youth with established diabetes is both costly and frequently preventable.     Poor glycemic control is a risk factor for hospitalization and is also associated with     adolescent age and lower socioeconomic status. This is a randomized, controlled trial for     high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm     and usual care control arm matched for frequency of contacts. There will be 110 subjects with     T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston     Children's Hospital and followed for 6 months. The intervention will be implemented by a     diabetes nurse educator and social worker, who will each have monthly contact with the     adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be     guided by a diabetes action plan. Telehealth interventions have been utilized successfully in     both adults and youth with diabetes. They facilitate frequent contact with the care team     allowing barriers to adherence to be addressed, education to be reinforced, care plans to be     updated, and diabetes-specific family support to be provided.   "
114851|NCT01782534|"     The relevant predictive hospital risk factors for 5-year mortality of patients with aortic     dissection is untill unlear. The aim of this study is to collect the clinical data of 111     hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically     analyze the hospital risk factors related to 5-year mortality by univariate and multivariate     binary logistic regression.   "
114852|NCT01782521|"     Orthodontic treatment is carried out by placing fixed attachments(brackets)on teeth with     wires which run through them and create tooth movement. These metal brackets are bonded     (glued) onto the tooth surface by a three step process. Firstly, a mild acid is used to     roughen the tooth surface, secondly a free flowing glue (composite primer) is used to fill in     the roughened pores and thirdly, the bracket is glued on to the tooth surface with a     'composite' material which sets hard by exposure to a high intensity light.The success of     this procedure is measured by bracket failure rates.      The literature review suggests that the scientific evidence is not clear to indicate whether     the use of a primer is absolutely essential to achieve acceptable bracket success rates in a     clinical environment.      The primary aim of the study is to find out if the rate of loss of orthodontic brackets is     clinically acceptable when they are glued onto the tooth surface without the use of a primer     as compared to brackets bonded with a primer over a 12 month study period. The investigators     will also investigate the Bonding time,Type of bracket bond failure,length of treatment and     Peer Assessment Rating scores (PAR)      This RCT will be undertaken on consented NHS patients in 3 hospitals in Yorkshire region by     multiple operators      The results from this study will help improve our knowledge of the best approach to bonding     metal brackets on teeth. If the bracket failure rate is similar in both groups, this would     indicate that the use of a primer is not always necessary. For patients, this would mean     lesser time required to place brackets at the start of orthodontic treatment. For clinicians     and NHS purchasers the outcome will influence cost effectiveness (as the primer is the most     expensive component in the bonding process) and provide a framework for future studies.   "
114853|NCT01782508|"     The purpose of this study is to compare the relapse free survival and overall survival of     Imatinib (Gleevec) or high dose Interferon (Intron) in treating melanoma which has primary     tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit     mutation. It is assumed that Gleevec may be more effective on relapse free survival as the     adjuvant treatment compared with Interferon.   "
114854|NCT01782495|"     This is a study to evaluate chronic Hepatitis C Virus infection.   "
114855|NCT01782482|"     The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as     compared to FRESHLOOK® COLORBLENDS contact lenses.   "
114856|NCT01782469|"     This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of     adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable     synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants     with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from     participants receiving adalimumab treatment who had not been treated with any other     anti-tumor necrosis factor (anti-TNF) therapy in the past.   "
114857|NCT01782456|"     The objective of this study is to capture information on gastrointestinal tolerance (GI) of     an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to     ≤ 10 years.   "
114914|NCT01781715|"     The purpose of this study is to determine outcomes (death, myocardial infarction, target     vessel revascularization (TVR), non-target vessel revascularization (non-TVR),     stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and     multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous     coronary intervention with Zotarolimus-eluting stents   "
114858|NCT01782443|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the drug, Ziv-aflibercept, is being studied. It also means that     the FDA has not yet approved Ziv-aflibercept for use in patients with your type of cancer.      Every person has molecules in their bloodstream called vascular endothelial growth factors     (VEGFs). These molecules help grow and sustain new blood vessels needed by the human body.     Cancer tumors hijack this mechanism because they need new blod vessels and oxygen to grow.     Ziv-aflibercept is an antibody. Antibodies are proteins that are produced naturally in our     bodies and help to recognize foreign substances in our body. Ziv-aflibercept is a targeted     therapy called a VEGF Trap, that traps (binds) these VEGFs and prevents the cancer from     using them to grow.      Though Ziv-aflibercept has not yet been FDA approved for the treatment of carcinoid tumors,     it has recently been approved for patients with treatment-resistant colorectal cancer.      In this research study, we will use Ziv-aflibercept in combination with standard octreotide     therapy to see if it slows the growth or spread of your carcinoid tumor. Standard octreotide     (sandostatin) therapy is currently approved for treating symptoms of carcinoid tumors, such     as those caused by carcinoid syndrome. Carcinoid syndrome is caused by hormones and other     substances released by carcinoid tumors into the bloodstream. One of these secreted     substances is serotonin, one of the body's natural chemical messengers. When excess serotonin     secreted by the carcinoid tumors reaches the body's tissues, it is thought to cause diarrhea     and redness (flushing) of the face, chest or back. Excess serotonin may also cause changes in     the structure of the heart valves, which can impair the heart's function. Octreotide works by     binding to receptors found on carcinoid tumors and prevents the release of hormones from the     tumor.   "
114859|NCT01782430|"     Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the     intubation of hypoxemic patients.   "
114860|NCT01782417|"     Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to     non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have     a higher prevalence of arthritis-attributed activity limitations (primarily related to OA),     are less likely to receive hip replacement independent of health care access, and are less     likely to receive knee replacement. The study is conducted to develop and test a telephone     delivered intervention for the management of OA in Hispanic adults. This study is conducted     as a minority supplement to the Patient and Provider Interventions for Managing     Osteoarthritis in Primary Care (PRIMO) NCT01435109 and Pro00022836.   "
114861|NCT01782404|"     This a prospective, non-controlled, open, multi-center study evaluating the reduction of     bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with     chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated     with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.      The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short     term reduction of bacteriuria in patients performing intermittent catheterization (IC).   "
114862|NCT01782391|"     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity     typically occuring during SWS has been implicated in the consolidation effect. Recent     evidence in young healthy subjects suggest that the sleep-associated consolidation effect can     be amplified by the application of a weak transcranial oscillatory electric current within     the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If patients with amnestic mild     cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus     dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS)     during nocturnal sleep as well has not been studied so far. The primary aim of the present     study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on     declarative memory consolidation applied during periods of nocturnal SWS in MCI patients.   "
114863|NCT01782378|"     The purpose of this study is to learn if an experimental treatment can help thinking ability,     and memory in Veterans with Gulf War Veterans Illnesses (GWVI). The experimental treatment     uses light-emitting diodes (LEDs), that are applied outside the skull, to the head using a     helmet that is lined with near-infrared diodes. LEDs are also placed in the nostrils (one red     diode: and one near-infrared diode), to possibly deliver photons to the deeper parts of the     brain. A treatment takes about 30 minutes. The participants receive a series of LED     treatments which take place as outpatient visits at the VA Boston Healthcare System, Jamaica     Plain Campus. The LEDs contain red and near-infrared diodes. The FDA considers the LED device     used here, to be a non-significant risk device. The LEDs do not produce heat.   "
114864|NCT01782365|"     The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is     well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its     slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory     representations. This impact of sleep on memory performance can be additionally enhanced by     exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency     range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy     subjects. If patients with amnestic mild cognitive impairment (MCI)- usually characterized by     initial difficulties in hippocampus dependent memory functions - benefit from transcranial     slow oscillatory stimulation (tSOS) during sleep as well has not been studied so far. The     primary goal of the study is therefore to investigate the impact of oscillating current     stimulation (tSOS) during a daytime nap on declarative memory consolidation in MCI patients.   "
114865|NCT01782352|"     The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in     25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study is being conducted among participants in VITAL and will     examine whether vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence     and/or progression of age-related macular degeneration (AMD).   "
114874|NCT01782235|"     Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by     lymphocytic infiltration leading to destruction of acinar and ductal cells and loss of     glandular parenchyma. The main symptoms of pSS are dry eyes and dry mouth, diffuse pain, and     fatigue. One third of patients develop systemic features, the most severe being lymphomas.      Serum IL-6 is increased in serum, saliva, and tears of patients with pSS. IL-6 plays a     pivotal role in B-cell activation, a hallmark of the pathogenesis of pSS, and in T-cell     differentiation. Tocilizumab, a recombinant humanised monoclonal antibody acts as an IL-6R     antagonist. The aim of this randomised double blind placebo controlled trial iss to evaluate     the efficacy of tocilizumab for the treatment of pSS.   "
114875|NCT01782222|"     This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement     of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic     Parkinson´s Disease.   "
114868|NCT01782313|"     This study is for patients who have been diagnosed with soft tissue sarcoma that has spread     (metastasized) or that is not eligible for removal by surgery. The purpose of this study is     to determine how soft tissue sarcomas respond to treatment with an investigational drug     called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere     with the growth of some types of tumors. The study will also evaluate how safe the study     treatment is by observing how many and what kind of adverse events (side effects)     participants experience.   "
114869|NCT01782300|"     Dengue viruses can cause dengue fever and other more severe forms of disease. This study will     evaluate the safety and immune response to two doses of a dengue virus vaccine given 12     months apart in healthy adults.   "
114870|NCT01782287|"     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into     chronic and non-lethal, the survival rates and life quality can be improved by of control of     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells     (TSCs).      Brief Description:      The first line therapy of brain metastases of lung cancer (BMLC) involves allogeneic     haploidentical hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic     lymphocytes (CTLs).      TCs and TSCs are isolated from BMLC sample. Dendritic cells are isolated from peripheral     blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to     prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are     harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF)     administration.      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six     months after the therapy completion, the efficiency is evaluated and the cohort demonstrating     efficiency continues the therapy, while cohort demonstrating no efficiency is transferred to     active comparator arm.      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with     modified proteome. Autologous HSCs are mobilized by G-CSF.      Carcinogenesis-free intracellular pathways of signal transduction able to respond to targeted     regulation of therapeutic cell systems with specific properties, are detected in TSCs using     complete transcriptome profiling of gene expression, proteome mapping and profiling of     proteins, bioinformation and mathematical analysis and mathematical modeling of protein     profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs regulation     are detected, as well as protein ligands able to regulate reproductive and proliferative     properties of TSCs.      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,     CTLs and autologous proteome-based HSCs.      Autologous proteome-modified HSCs, DV and CTLs are administered as in the first line therapy.   "
114871|NCT01782274|"     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into     chronic and non-lethal, the survival rates and life quality can be improved by of control of     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells     (TSCs).      Brief Description:      The first line therapy of brain metastases of breast cancer (BMBC) involves allogeneic     haploidentical hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic     lymphocytes (CTLs).      TCs and TSCs are isolated from BMBC sample. Dendritic cells are isolated from peripheral     blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to     prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are     harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF)     administration.      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six     months after the therapy completion, the efficiency is evaluated and the cohort demonstrating     efficiency continues the therapy, while cohort demonstrating no efficiency is transferred to     active comparator arm.      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with     modified proteome. Autologous HSCs are mobilized by G-CSF.      Carcinogenesis-free intracellular pathways of signal transduction able to respond to targeted     regulation of therapeutic cell systems with specific properties, are detected in TSCs using     complete transcriptome profiling of gene expression, proteome mapping and profiling of     proteins, bioinformation and mathematical analysis and mathematical modeling of protein     profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs regulation     are detected, as well as protein ligands able to regulate reproductive and proliferative     properties of TSCs.      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,     CTLs and autologous proteome-based HSCs.      Autologous HSCs, DV and CTLs are administered as in the first line therapy.   "
114872|NCT01782261|"     Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune     cells in healthy subjects and patients with type 1 diabetes   "
114873|NCT01782248|"     The aim of this study is to characterize the deficit in critical components of personal     identity (self-consciousness and social cognition) in patients with Alzheimer's disease (AD)     and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a     neuropsychology and multi-podal neuroimaging study.      We posit that the alteration of some aspects of self-consciousness (autobiographical memory,     nosognosia, metacognition) and social cognition (theory of mind and facial) results in     personality changes in the patients, primarily due to the alteration of self-consciousness in     AD and to social cognition in FTLD.   "
114876|NCT01782209|"     The objectives of this study is to establish the natural history of BK virus viremia and     other possible opportunistic viral pathogens in renal transplants receipients.   "
114915|NCT01781702|"     A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap.     for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients   "
124884|NCT01651052|"     The purpose of this observational trial is to gather further clinical data to confirm the     safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this     trial population.   "
114878|NCT01782183|"     Thermographic cameras are used to determine temperature and temperature differences. Attempts     have been made to use the thermographic camera as a diagnostic tool in clinical practice.     Thermographic cameras have been approved by the FDA in the diagnosis of breast cancer. The     camera absorbs infrared radiation which is discharged from the tissue and than translates it     to a digital data or a photograph. The camera does not radiate and direct contact with the     patient is not needed. The safety is similar to a regular optic camera. No study on     thermographic characteristics of inflammation of organs has been published. The purpose of     this study is to demonstrate and document these characteristics of inflammation. The     correlation between the thermographic imaging and the clinical diagnosis, using routine     methods, will be analyzed. The differences of thermographic imaging between an inflamed organ     of a subject to a non inflamed same organ of a normal control will also be analyzed. The     management of the patient will be by standard practice and will not be influenced by the     thermographic camera image and the study outcome.   "
114879|NCT01782170|"     The purpose of this study is to explore the efficacy of Iocide oral rinse in a human clinical     trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse. Indices for     gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine     the effect of the antimicrobial oral rinse on relative levels of biological markers of     inflammation.   "
115171|NCT01778361|"     Despite the prevalence of osteopenia and osteoporosis in the HIV positive population,     relatively little is known about the underlying pathology. This prospective cohort study aims     to gain further understanding about a number of issues relating to low bone mineral density     in HIV-infected subjects.   "
114880|NCT01782157|"     The world's population is aging and the resulting prevalence of chronic illnesses is a     challenge that our society must address. The vision is to address this challenge by designing     smart environment technologies that keep older adults functioning independently in their own     homes as long as possible. Smart environments have been used as the basis of monitoring     activities for residents with health conditions. However, there is currently a lack of large     scale, longitudinal research to identify early markers of dementia and other health status     changes and to predict functional decline. The objective of this project is to perform a     5-year longitudinal study of older adults performing daily activities in their own smart     homes.   "
114881|NCT01782144|"     Obesity is a serious medical, social, and economic problem and is becoming even greater     concern, as the prevalence of overweight and obese individuals has steadily increased over     the years. Excessive body weight can have a profound influence on lower extremities,     including pain, degenerative disease, and compromised quality of life. However, no study     to-date has examined the effects of weight change on foot structure and function in     individuals over time. The purpose of this study is to determine the effects of weight     reduction on foot structure and function in obese adults. Improved understanding of the     relationship between body weight and foot biomechanics is needed to promote health and     healthier lifestyles.   "
114883|NCT01782118|"     Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux     disease (GERD). However, they may be associated with an increased risk of gastrointestinal     and respiratory tract infections.      Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the     risk of gastrointestinal and respiratory tract infections in children with GERD.      Study design: Randomized, double-blind, placebo controlled trial.   "
114884|NCT01782105|"     The purpose of this study are:        -  Assess the impact of an intervention to the adoption of healthy lifestyles among          pregnant women at high risk of gestational diabetes mellitus on:             -  weight gain in pregnancy             -  the levels of maternal and fetal adipokines and             -  glycemic control maternal and fetal.        -  Determine whether the adoption of healthy lifestyles in pregnancy is associated with          epigenetic changes that influence the levels of adipokines and glucose regulation during          pregnancy and in newborns.   "
114885|NCT01782092|"     The purpose of this study (15-subject prospective case series) is to examine the effects of     the Activator Methods technique on decreasing A1c levels in patients with type II Diabetes     Mellitus (aka adult-onset diabetes).   "
114886|NCT01782079|"     The aim of this study is to select the optimal conditions for quantification in the oral     cavity of Lactobacillus brevis CD2, a probiotic strain contained in a commercially available     dietary supplement and to assess its persistency after oral administration. Different sets of     primers for L. brevis detection will be tested in real-time PCR reactions to find optimal     amplification efficiency and target specificity. Primers ability in the identification of L.     brevis DNA will be assessed in a pilot study conducted on 12 healthy volunteers clinically     free of oral pathologies. The subjects will take 3 tablets/day for 3 days and one tablet on     the 4th day. Clinical samples (dorsal surface of tongue, first molar, vestibular fornix and     saliva) will be collected at baseline (before beginning the trial), at T0 (in the morning     before the assumption of the last tablet) and 3, 6, and 9 hours after taking the last tablet.     The quantities of L. brevis DNA will be compared to the total number of bacteria present in     the samples. The activity of the enzyme arginine deiminase, responsible for oral pH     homeostasis (particularly abundant in the CD2 strain) will be also assessed in the saliva     samples before and after treatment, by HPLC measurements.   "
114887|NCT01782066|"     Invasive meningococcal disease is a worldwide problem with serious repercussions for those     affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is     prohibitive in many low-resource settings at home and abroad. By harnessing the special     immunologic properties of the skin, a dose reduction may be achieved by intradermal     administration of the vaccine. The cost savings associated with dose reduction will increase     availability of the vaccine.   "
114888|NCT01782053|"     Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and     Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette     packs as well as nine new statements of smoking risks. This trial tests the effectiveness of     the warnings proposed by the Food and Drug Administration by providing cigarettes with the     proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In     addition, the trial tests the effects of different warning label components.   "
114943|NCT01781338|"     Trial for the optimization of risk assessment and therapy success prediction in patients with     early breast cancer by the use of biomarkers in advance to therapy decision-making to     personalize therapies.   "
114889|NCT01782040|"     Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a     woman's menstrual cycle. These symptoms occurring only during the luteal phase of the     menstrual cycle that are of sufficient severity to interfere with some aspects of life of     these women, reflecting also in interpersonal relationships, workplace and in their     productivity. For these reasons, this research was conducted with the nursing staff of the     Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to alleviate     some of the symptoms of PMS.   "
114890|NCT01782027|"     The purpose of this study is to investigate the use of radiolabeled particulate cholesterol     administered intravenously in association with albumin, as a method to study reverse     cholesterol transport (RCT) in people carrying mutations in genes known to affect high     density lipoprotein (HDL) metabolism by analyzing changes in the tracer activity in total     plasma, lipoproteins fractions and feces.   "
114891|NCT01782014|"     The purpose of this study is to determine which of the methods of colonoscopy viz. water     insufflation or air insufflation or carbon dioxide insufflation is better in detecting the     adenomas in colon and also which of these methods is best tolerated by patients.      Hypothesis: the investigators hypothesize that in patients undergoing first time screening     colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group     randomized to the water method compared to those randomized to the air or CO2 insufflation     methods   "
114892|NCT01782001|"     The purpose of this study was to determine whether young children receiving Vitamin A and     Zinc supplements will have a lower incidence of symptomatic malaria than similar children     receiving vitamin A supplements alone.   "
114894|NCT01781975|"     Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing     ß cells. Although exogenous insulin is widely available, it is not possible for affected     individuals to consistently achieve euglycemia with current technology, and thus they are at     risk for devastating long-term complications. This phase II study is designed to evaluate the     safety and efficacy of imatinib mesylate as a novel therapy for new-onset T1DM. Imatinib is a     first-in-class tyrosine kinase inhibitor.      This study will explore the potential role of short-term therapy with imatinib to induce     tolerance and possibly lead to a durable long-term remission of T1DM.   "
114895|NCT01781962|"     This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular     Hypertension.   "
114896|NCT01781949|"     The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening     methods, including a novel targeted strategy, in urban emergency department settings in the     United States.   "
114897|NCT01781936|"     The purpose of this study is to determine the tolerability, safety, and benefits of an     investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have     posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical     implant, Retisert, which is approved by the U.S. Food and Drug Administration (FDA) to treat     non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology     (eye) clinic; whereas Retisert must be surgically implanted in the Operating Room. Initially,     this was a 2-dose randomized pilot study. However, the study was modified to include only the     0.2 ug/day implant.   "
114898|NCT01781923|"     The goal of this study is to collect preliminary data on the efficacy of a cognitive     remediation program in improving the neurocognitive deficits in children with chromosome     22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a     computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a     Social Cognitive Training (SCT) program. The computer-based training program has shown     encouraging results in improving learning deficits in individuals with schizophrenia and we     now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ     and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group     intervention program based on cognitive enhancement therapy, which has been shown to improve     social cognition and functionality in adults with schizophrenia. A preliminary study will be     performed using this two-pronged approach, to establish the feasibility and gather     preliminary data on neurocognition before and after the intervention in these children; these     data would enable a larger randomized controlled study to assess the efficacy of this     approach.   "
114899|NCT01781910|"     The purpose of this study is to determine if a dietary supplement containing branched chain     amino acids will reduce the muscle soreness that sometimes occurs in the days following     exercise.   "
114900|NCT01781897|"     The purpose of this study is to investigate the effect of electroacupuncture on functional     constipation.   "
114901|NCT01781884|"     This study is a multicenter, randomized, double-masked, placebo-controlled clinical study.     All groups will receive standard intensive diabetes treatment with insulin and life style     management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or     different dosage of GABA.      GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was approved     for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used as     supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has     been recently shown that GABA can prevent and reverse the development of diabetes in type 1     mice models. Participants will receive placebo or GABA for 52 weeks.      The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks treatment     period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years.      To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in     new onset subjects.   "
114964|NCT01781065|"     The purpose of this study is to evaluate the analgesic effect of transcranial direct current     stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have     chronic neuropathic pain.   "
114902|NCT01781871|"     Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant     morbidity and mortality in both otherwise healthy adult population and in the     immunocompromised patients. The incidence rate of invasive pneumococcal disease is     considerably higher among organ transplant patients than in healthy individuals. Routine     immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after     the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide     vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine     has been shown to be more immunogenic and safe in some other subgroups of immunocompromised     patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal     conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal     polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.   "
114903|NCT01781858|"     The course of both pulmonary embolism (PE) and one of its more relevant late complications,     i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown.      Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but     this has not been confirmed by other studies. A clear link between PE and CTEPH has been     questioned by some experts. A great number of patients affected by PE persistently have     residual chronic thromboembolic material the meaning of which is a matter of debate. The     evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH     is insufficient.      Thus, a nationwide, multicentre, prospective cohort study was designed with the following     aims:        1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE;        2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first          episode of acute PE;        3. to evaluate whether a relation exists between chronic residual PE and CTEPH        4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences;        5. to evaluate whether a relation exists between persistent right ventricular dysfunction          and CTEPH;        6. to evaluate whether a relation exists between persistent right ventricular dysfunction          and PE recurrences.      For each enrolling centre, consecutive outpatients or inpatients with an objectively     diagnosed first acute PE episode are considered eligible.   "
114904|NCT01781845|"     Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be     either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by     ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed     systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by     measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave     velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as     the reference standard.   "
114905|NCT01781832|"     Urinary bladder fibrosis is relatively uncommon in children. Traditionally, the presence of     urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic     testing. In this study we will use ARFI (acoustic radiation force impulse)-derived shear wave     velocities to potentially identify any urinary bladder wall fibrosis.   "
114906|NCT01781819|"     Urine reflux (urine backing up into the kidneys) is common in the pediatric population and     may be complicated by renal abnormalities, such as infection and scarring. Currently, urine     reflux is detected using either voiding cystourethrogram or other procedures. A new technique     called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave velocity     imaging SVI) is performed using standard approved ultrasound machines and transducers bu the     sound waves/impulses are produced in a different pattern. We hope to evaluate the usefulness     of ARFI in diagnosing possible kidney damage caused from urine reflux (urine backing up into     the kidneys).   "
114907|NCT01781806|"     The purpose of this study is to evaluate the safety, acceptability and feasibility of     delivery of PrEP or PEP as part of combination HIV prevention services for high-risk MSM and     transgender women.   "
114908|NCT01781793|"     Exertional dyspnea is a major source of crippling distress and is the hallmark symptom of     fibrotic interstitial lung disease (ILD). Due to the scientific community's poor     understanding of the pathophysiological mechanisms of dyspnea there are no therapeutic     interventions that consistently reduce dyspnea in this population. The investigators aim to     determine the physiological mechanisms of exertional dyspnea in patients with fibrotic ILD     and the impact of hyperoxia on exertional dyspnea and exercise endurance. This study will     likely identify an important physiological mechanism of dyspnea in fibrotic ILD and may     contribute to the development of effective therapies to reduce dyspnea in this population.      The central hypothesis is that dyspnea in fibrotic ILD is primarily a result of an imbalance     between the drive to breathe and the tidal volume response of the respiratory system (i.e.,     neuromechanical uncoupling) and that experimental reduction of neuromechanical uncoupling via     hyperoxic breathing will reduce exertional dyspnea and improve exercise endurance.   "
114909|NCT01781780|"     This is an experiment that will compare the effect of recommending breakfast consumption, or     breakfast skipping, on body weight. Our objective is to determine if breakfast consumption     recommendations can produce weight loss, and if that weight loss is dependent on typical     breakfast eating habits.   "
114910|NCT01781767|"     This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2)     mRNA expression as function of thyroid activity (TSH, T3 and Free T4).   "
114911|NCT01781754|"     Many patients with Diabetes find difficulties in achieving glycemic control. Hemoglobin     A1c(HgBA1c) is used as a marker for glycemic control. UCP2 is affected by high glucose     levels, high free fatty acids and high oxidative stress.      The investigators intend to learn about the changes in UCP2 along the process of reaching     glycemic control.   "
114912|NCT01781741|"     This pilot clinical trial studies stereotactic body radiation therapy after surgery in     treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation     therapy may be able to send x-rays directly to the tumor and cause less damage to normal     tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in     patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after     lymphadenectomy may kill any tumor cells that remain after surgery.   "
114913|NCT01781728|"     The investigators are looking to see if a certain dose of stereotactic body radiation therapy     (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary     adenocarcinoma.   "
114916|NCT01781689|"     Stroke is the most common cause of motor function impairment. However, the functional     impairment is not totally irreversible. Several mechanisms may involved in both the cortical     and motor function recovery after onset of stroke, and most of them are related to changes of     cortical perfusion and metabolism.      Motor function recovery after stroke (especially middle cerebral artery territory lesion)     frequently follow stereotypic pattern (brunnström stage).      This study is designed to investigate the relationship between motor cortex     oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar     stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage     after stroke.   "
114917|NCT01781676|"     This study was advocated by institute of Basic Research in Clinical Medicine,China Academy of     Chinese Medical Sciences in October 2011.      It was funded by China major scientific and technological specialized specialized project for     'significant new formulation of net drugs'.      Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart     diswese、angina pectoris and stroke in many Chinese hospitals.      The purpose of this study is to determine adverse drug events or adverse drug reaction in     large sample size 30,000 patients.   "
114918|NCT01781663|"     The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face     Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will     be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects     treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group     of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be     determined by the number and severity of Adverse Events Device-Related.   "
114967|NCT01781026|"     The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain     metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are     not amenable to stereotactic radiosurgery based on size, number of lesions or location, to     measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of central nervous     system penetrance and to measure levels of vemurafenib in normal brain tissue and brain     metastases in those in whom surgical management is feasible.   "
114919|NCT01781650|"     Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water     Immersion (WI), characterized by suction removal of the infused water predominantly during     the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction     removal of infused water predominantly during the insertion phase of colonoscopy. Several     studies showed that WE significantly reduces pain compared to WI and colonoscopy with     traditional air insufflation (AI), increases the number of unsedated procedures and adenoma     detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a     direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the     hypothesis that WAC (particularly WE) would significantly decrease pain score during     colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.   "
114920|NCT01781637|"     The investigators will perform a double blind, placebo controlled clinical trial with Xolair     (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut     allergy. The investigators will determine if pretreatment with anti-IgE mAb     (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer     desensitization.   "
114921|NCT01781624|"     The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional     supplement containing a new protein blend in healthy elderly subjects.   "
114922|NCT01781611|"     Dipyridamole, a medication extensively used in combination with aspirin for stroke     prevention, is a promising new treatment for lupus. Dipyridamole has been shown to inhibit     certain lymphocyte populations that are over-reactive in lupus and to delay the emergence of     lupus-related pathology in mice with lupus. The investigators are interested in investigating     the efficacy of dipyridamole in preventing flares in patients with lupus and its impact on     biomarkers of disease activity.   "
114923|NCT01781598|"     Description of logistics, learning curve and radiological results in 70 patients treated with     patient specific instrumentation in total knee arthroplasty as a standard procedure   "
114924|NCT01781585|"     Hemodynamic instability occurs frequently during dialysis treatment and still remains as     significant cause of patient mobility and mortality. Postoperative hemodynamic optimization     has been proved to reduce morbidity in high-risk patients. Intracranial pressure increased     can lead to further structural and functional impairment owing to its deleterious effect on     the compromised microcirculation and metabolism. This study was to compare the intra-cerebral     pressure (ICP) and hemodynamic parameters between the sustained low-efficiency dialysis     (SLED) and continuous veno-venous hemofiltration (CVVH) in post- brain tramatic patients.   "
114925|NCT01781572|"     In the phase Ib, the primary purpose is to establish the maximum tolerated dose     (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally     administered combination. Once the MTD(s)/RP2D have been determined for each tested schedule,     additional patients will be enrolled in the phase II portion of the study at the RP2D on the     chosen schedule in order to assess the anti-tumor activity of the combination in addition to     continued evaluation of safety.   "
114926|NCT01781559|"     The objective is to demonstrate the effect of phenolic acids on endothelial function.   "
114927|NCT01781546|"     The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of     bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB     is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients     at high risk of bleeding.   "
114928|NCT01781533|"     To investigate the performance of a software-algorithm based insulin therapy to control blood     glucose in Type 1 diabetic patients.   "
114929|NCT01781520|"     The purpose of this study is to evaluate the antitumor effect and safety of clinical     effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK)     for unresectable locally advanced pancreatic cancer.   "
114930|NCT01781507|"     Primary Objective :      To compare the acute bronchodilatory effects of cetirizine 10 mg tablet and nebulized     levalbuterol using impulse oscillometry technique in asthmatic subjects aged 18 to 65 years     old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.      Secondary Objective:      To assess the bronchodilatory effects of cetirizine 10 mg tablet versus placebo after two     weeks of therapy using impulse oscillometry technique in subjects 18 to 65 years old who have     allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.   "
115058|NCT01779830|"     The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy     people. The study has four treatment periods. Participants will receive a single dose of     LY2624803, another sleeping pill, or placebo in each treatment period. The study will last     approximately 1 month for each participant.   "
114931|NCT01781494|"     The goal of this study is to test the hypothesis that immediate elbow motion is safe after     anterior submuscular ulnar nerve transposition, and will not result in disruption of the     repaired flexor pronator origin, under which the nerve is placed. The advantages of immediate     elbow motion after submuscular ulnar nerve transposition for performing activities of daily     living and self-care are evident, however theoretical advantages include early gliding of     the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent traction     neuritis, as well as improved blood flow and quicker, more complete, recovery of nerve     function.      A group of 44 consecutive patients that are determined to be candidates for anterior     submuscular ulnar nerve transposition based on history, positive findings on physical     examination, and confirmatory electrodiagnostic testing will be prospectively randomized to     either immediate motion or long arm cast immobilization after surgery. All patients will be     counseled about the two postoperative treatment options (immobilization followed by protected     range of motion versus immediate range of motion), risks involved with each treatment     protocol, postoperative follow-up and need for radiographs. If they choose not to     participate, they will be treated by the same postoperative protocol currently used by the     principal investigator: arm sling at rest for six weeks with intermittent active assisted     range of motion exercises.   "
114987|NCT01780766|"     Whole body MRI with diffusion weighted imaging is a useful imaging tool        -  staging and diagnosis        -  therapy monitoring All patients will be scanned before and during treatment. The          findings on diffusion weighted imaging will be correlated to the golden standard          (computer tomography and MRI (T1 and STIR)).   "
114932|NCT01781481|"     The investigators have recently developed a paediatric adaptation of the INTERMED tool to     address the unique developmental and social contexts of children and youth. The Pediatric     INTERMED adopts a life-chart methodology to structure and organize complex case material in     time, colour-coding domains to facilitate identification of areas of high need and risk for     each patient. The focus of the present study is to examine the characteristics and usefulness     of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory     Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents     will participate in a semi-structured structured interview with a clinical nurse who will     then rate the 34-PIM items. To examine the construct validity of each of the Pediatric     INTERMED domains (biological, psychological, social, caregiver/family, health care system)     participants will complete questionnaires assessing social and psychological functioning,     parent and family stress, quality of life and adaptive functioning. Information about disease     status, and health care utilization will be obtained from medical chart review. It is     hypothesized that greater case complexity will be predictive of more complex disease     course/treatment, poorer quality of life, and increased health care utilization.   "
114933|NCT01781468|"     This randomized phase III trial studies armodafinil to see how well it works in reducing     cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve     fatigue in patients with high grade glioma.   "
114934|NCT01781455|"     This is an open label, single arm dose escalation study of BBI503 in adult patients with     advanced solid tumors.   "
114935|NCT01781442|"     This is a post marketing surveillance which determines the safety profile of the product to     Filipinos. This is a FDA requirement for registration.   "
114936|NCT01781429|"     This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and     pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The     study also seeks to demonstrate target modulation and early signs of clinical response in     select patient populations.   "
114937|NCT01781416|"     This is a national, non interventional, prospective study performed in the general practice     setting.      The study has been designed :        -  to assess the level of concordance between patients' cardiovascular risk perception and          the cardiovascular risk evaluated by the physicians,        -  and to evaluate the impact of patients' exposure to a medical information leaflet on          patients' cardiovascular risk perception.   "
114938|NCT01781403|"     The investigators planned a phase I study of preoperative CRT with capecitabine plus     temozolomide inpatients with locally advanced resectable rectal cancer: 1) the role of     temozolomide as a radiosensitizer has been well established, 2) hypermethylation (or low     expression) of MGMT promoter is associated with colorectal carcinogenesis, can be found in     20~40% of colorectal cancer patients, and this proportion could be adequate for validation as     its role of predictive biomarker, and 3) temozolomide can be additive or synergistic because     radiotherapy is now essential in the treatment of rectal cancer.   "
114939|NCT01781390|"     This is a double blind, randomized, placebo controlled study that will enroll 225 subjects     with de novo anterior myocardial infarction due to a lesion of the left anterior descending     coronary artery undergoing PCI. Eligible subjects will be enrolled and undergo     revascularization of the culprit LAD followed by an intracoronary (IC) delivery of the     assigned treatment, infused into the stented culprit artery. The study will determine the     safety and feasibility of the IC infusion of investigational MPCs in this patient population.   "
114940|NCT01781377|"     Perioperative nausea and vomiting may occur in 50-80% of patients undergoing cesarean     section.      Metoclopramide is a well known Dopamine receptor antagonist that acts at the Chemoreceptor     trigger zone and is used effectively for the prevention and treatment of nausea and vomiting.     Propofol can antagonize Serotonin receptors in the area postremal and is associated to a     reduced incidence of postoperative nausea and vomiting. Some studies have shown that propofol     can prevent intraoperative nausea and vomiting during cesarean section.      The control of risk factors and the pharmacological prophylaxis of nausea and vomiting     reduces effectively their incidence.      In this randomized, double blind, case-control study the efficacy of propofol alone,     metoclopramide alone and in combination in controlling nausea and vomiting were compared. A     risk factor control strategy was associated to each study group.   "
114941|NCT01781364|"     The purpose of this study is to reveal the specific effects of computer-aided cognitive     training on course and rehabilitation in early onset schizophrenia   "
114942|NCT01781351|"     Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim     of our study is to quantify the stabilizing effect of different devices. Through the combined     use of the 3D motion analysis and the surface electromyography, the influence of the devices     with respect to a mechanical effect and to an influence on the neuromuscular control are     examined. The tests will simulate situations with a higher risk of injury. In the     experimental set-up, an element of surprise will be integrated in order to analyze any     muscular compensation mechanisms.   "
114944|NCT01781325|"     Our objective is to develop an IBEHR (Image-Based Electronic Health Record) to show patients     how to reproduce at home the exercises prescribed by their physical therapist (PT) in clinic.     The IBEHR can also record home exercise sessions for review by and feedback from the PT. The     HEALTH CARE BENEFITS of the IBEHR for patient self monitoring are: improved transfer of     physical therapy exercise from clinic to home, increased adherence to the exercise     prescription, and recording home exercise to assist PT decision making.   "
114945|NCT01781312|"     Recent studies have shown an increased gastrointestinal reactivity and increased intestinal     permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the     gastrointestinal immune system possibly by improvement of both the immunologic and the     non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have     an effect on IgAN. In this study the investigators will study the efficacy and safety of     Lactobacillus reuteri.   "
114946|NCT01781299|"     The purpose of this study is to assess the relative performance and complication rates     between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of     these two treatment options.   "
115249|NCT01777321|"     The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK     Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC)     as compared to intramuscularly (IM) to people 50 years of age and older.   "
114947|NCT01781286|"     The purpose of this study is to examine the effects of normal vs. protein-rich afternoon     snacks on appetite control, satiety, and reward-driven eating (particularly in the evening)     in young people. Indices of attention and mood will also be assessed.      Study hypotheses include the following:        1. The consumption of a high-protein, soy-rich afternoon snack will lead to significant          improvements in appetite control and satiety, reductions in food motivation and reward,          and will delay the drive to eat in normal to overweight young people.        2. The consumption of a high-protein, soy-rich afternoon snack will lead to reduced          unhealthy, evening snacking, particularly on foods high in fat and/or sugar, in normal          to overweight young people.        3. The daily consumption of a high-protein, soy-rich afternoon snack will lead to          significant improvements in afternoon alertness, concentration, fatigue, and well-being          in normal to overweight young people.   "
114948|NCT01781273|"     This four-way, dose-response, crossover, double blind, placebo-controlled, randomised     validation study investigates the responsiveness of MedDrive, a computed battery of     neuropsychological tasks, to different doses of alcohol.      The following hypothesis are tested:        1. Measures from MedDrive are influenced by alcohol in a dose dependent way.        2. Effects of alcohol on driving performances are correlated to measures from MedDrive in a          dose dependent way.        3. Within a group of healthy young drivers, MedDrive shows consistent results over repeated          measures (ICC≥0.7).        4. MedDrive models effects of alcohol on driving performances better than does the UFOV or          the trial making task.   "
114949|NCT01781260|"     Recent occurrence of significant post-operative liver impairment at Nottingham University     Hospitals NHS Trust has prompted investigation into whether interaction between general     anaesthesia and prone positioning (lying face down) for surgery can influence liver function.      Historical research has shown that the heart does not function as efficiently when an     anaesthetised patient is placed in the prone position for surgery. The techniques used for     anaesthetising and monitoring these patients have changed remarkably, since these studies     were first performed.      It is important to know accurately how the heart functions to enable better understanding of     the changes in blood flow to the liver when in the prone position.      Studies looking at blood flow to the liver when lying face down have been done before but are     mainly reporting patients on the intensive care unit. These intensive care patients are     different to those in theatre undergoing routine surgery. The intensive care patients are     usually received in different types of drugs and monitored with several different types of     monitor at the time. Perhaps most importantly is that they are placed face down on a soft air     cushioned mattress and pillows rather than the rigid support used for surgical patients.      This study will look at whether the function of the liver changes when a patient is     anaesthetised and is then rolled onto their front. The function of the liver will be measured     by looking how it clears a specific drug from the blood. Also this study will look at how     accurate a particular type of heart monitor is when an anaesthetised patient is placed onto     their front.   "
114950|NCT01781247|"     Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone     experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to the     traumatic experience of myocardial infarction (MI). PTSD is associated with impaired quality     of life, social functioning, and high economic burden to the society. Posttraumatic stress     attributable to MI has also been shown to be predictive of poor cardiovascular prognosis,     whereby this link might relate to several atherothrombotic processes. Therefore the     prevention of PTSD after MI is of high relevance. Guidelines have been published for early     interventions to prevent the development of posttraumatic stress after different types of     trauma but not in terms of acute MI as a traumatic event.      The overarching aim of the planned trial is to test whether a minimal behavioral intervention     performed shortly after acute MI in patients at a high risk to develop PTSD and in the     setting of a coronary care unit reduces the development of posttraumatic stress.      The primary hypothesis is that posttraumatic stress levels at the 3-month follow-up will be     at least 20% lower in the intervention group than in the control group, and that this effect     will last up to 12 months after the intervention. The secondary hypothesis is that the     intervention group will show better psychosocial functioning, and a more favourable     cardiometabolic biomarker profile than the control group 3 and 12 month after the     intervention.   "
114951|NCT01781234|"     This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers.     Groups' (placebo vs. insulin) cognitive function and stress response will be compared.   "
114952|NCT01781221|"     The purpose of this study is to compare the regenerative results of using separately two     different xenografts after two-step sinus floor elevation.   "
114953|NCT01781208|"     ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound     guided needle biopsy of the liver of children.   "
115103|NCT01779245|"     A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this may     be due to a shift in substrate metabolism where there is an increase in the rate of fat     oxidation. However, whether high-calcium intake can influence substrate metabolism during     exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of     high-calcium intake on substrate metabolism during exercise.   "
114954|NCT01781195|"     Prolonged-release low-dose Advagraf should better protect from CNI-side effects compared to     standard immunosuppressive regiments while the rate of rejection is not increased and thus     graft function is well maintained. We hypothesize that especially in high-MELD (MELD-score     >20) recipients who have a decreased immune competence the prolonged-release low-dose     Advagraf concept would better protect from side effects of immunosuppression (i.e.     infection). Nevertheless, we assume that also patients with a MELD-score ≤20 will benefit     from this concept in regard to lower infection rates and less side effects of     immunosuppression.   "
114966|NCT01781039|"     Understanding speech is essential for good communication. Individuals with hearing loss and     poor speech discrimination often have little success with hearing aids because amplifying     sound improves audibility, but not clarity of the speech signal. The purpose of this study is     to determine the relative importance of the sensory cells of the inner ear and auditory     neurons on speech discrimination performance in quiet and in noise. This information may be     used as a predictor of hearing aid benefit. The investigators expect to find decreased speech     understanding ability resulting from both loss of sensory cells and the loss of auditory     neurons.   "
114955|NCT01781182|"     Escalating resistance to antibiotics among disease-causing community bacteria increasingly     threatens our ability to treat patients' infections. At the level of the physician-patient     encounter, incentives at the patient level often take priority to society; this is often the     case with antibiotic prescribing. Each patient level antibiotic treatment decision is based     on how we value potential outcomes, including short-term benefits and risks and longer-term     risks, including those related to future bacterial resistance to antibiotics. Unfortunately,     antibiotics are often prescribed for illnesses unlikely to have a bacterial etiology; even a     very small likelihood of benefit seems to outweigh an increased risk of future antibiotic     resistance. While short-term effects of antibiotics on colonization with resistant bacteria     have been demonstrated, the overall implications of each treatment for future individual,     family and societal-level resistance remain difficult to quantify, and are often steeply     discounted or ignored during decision-making. Knowledge regarding the longer-term effects of     personal and household antibiotic use could better quantify these future resistance-related     risks, and help guide antibiotic decision-making for physicians and patients.      Infants are born with sterile nasopharyngeal and gastrointestinal tracts and yet, during the     1st year of life, become important reservoirs of resistant organisms; this creates an     opportunity to study colonization and resistance starting from a microbiological tabula rasa.     In this proposal, we will use an observational cohort to following newborns' antibiotic     exposure and longitudinal colonization with specific bacterial pathogens and related     antibiotic resistance in the 1st year of life. Our hypothesis is that during the 1st year of     life, infants with personal and household antibiotic exposure will have greater colonization     with resistan organisms than infants without antibiotic exposure. This project will help us     understand the development of bacteria that are resistant to antibiotics within the     community, and help to inform judicious decision-making regarding antibiotic prescribing.   "
114956|NCT01781169|"     Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid     Hormone and Insulin Resistance in Obese Chinese Males.      Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks     to the obese males compared with the normal-weight males. Index measures were conducted at     baseline and endpoint.   "
114957|NCT01781156|"     Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in     end stage renal diseases(ESRD),however the majority of whom are in the absence of acute     coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in     those patients. We hypothesized that excessive phosphorus is account for that phenomenon.To     confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in     hemodialysis patients for some time and observed the change of cardiac biomarkers of those     patients.   "
114958|NCT01781143|"     The SOET project introduces a new strategy for routine follow-up of follicle growth during     the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a     learning instruction and demo, patients should be able to perform most of their vaginal     echoes at home. The images can be sent to the medical center over the internet. These images     are analyzed by the expert.   "
114959|NCT01781130|"     Background      Present treatment strategies for trigger finger when conservative management including     steroid injection was failed include percutaneous or open A1 pulley release, but some people     showed prolonged swelling and delay of complete healing.      We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid     injection simultaneously with percutaneous release compared with conventional percutaneous     release alone      Methods      We designed a double-blind, randomized controlled trial.      Inclusion criteria is the patient who has symptom of trigger finger warranted surgical     release after sufficient time of conservative treatment.      Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid     arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5)     Previous surgery history of finger 6); the patients who got steroid injection more than 4     time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.      After power analysis by a statistician, total 40 patients would be required for each group     (percutaneous alone group versus percutaneous alone + steroid injection group).      The surgery will be performed by outpatients clinic basis with local injection. Additional     steroid injection will be given to half of patients after allocation with randomized     selection by permutaed block randomization.      Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary     outcome will be proportion of patients with good response (defined as Perfect or much     better as reported by patients).      Follow-up will be conducted 3 weeks and 3 month after index procedure   "
114960|NCT01781117|"     Persistent detrusor overactivity (DO) after transurethral prostatectomy results in     symptomatic failure in more than one third of the patients. Storage symptoms are major     complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate     (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and     smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased     after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with     benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO     by the medical or surgical treatment have not been fully investigated. If the elevated     urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of     urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the     operation.      The aims of this study are to measure the urinary NGF levels in patients with BPO and to     compare the results between the patients with detrusor overactivity (DO) and without detrusor     overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate     (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of     postoperative 3 months and 6 months, and compare changes between the two groups.   "
114961|NCT01781104|"     The purpose of this study is to evaluate safety and tolerability as well as the effects of     RM-131 on colonic transit, bowel consistency, bowel habits, abdominal pain, and other     abdominal symptoms in patients with chronic constipation.   "
114962|NCT01781091|"     Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to     extubation or death in ICU patients requiring mechanical ventilation measuring duration of     mechanical ventilation in order to design a multicenter large trial.   "
114963|NCT01781078|"     The objective of the SAMURAI Clinical Study is to collect data to confirm the safety,     performance and effectiveness of the ImageReady System for use in the Magnetic Resonance     Imaging (MRI) environment when used in accordance with the Conditions of Use included in the     Boston Scientific MRI Technical Guide   "
114965|NCT01781052|"     This prospective, non-interventional, multi-center study documents observational data on     subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III     with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The     observation period for each subject covers a one year treatment period with inhaled Ventavis.     For each subject, the investigator or a delegate collects data as defined in the case report     form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.   "
114968|NCT01781013|"     The specific aims of the proposed study are to:        1. Develop the innovative depression care management technology, including the speech          recognition technology for automated monitoring and patient prompts over time, automatic          integration of the responses into the patient registry, and evidence-based          decision-support algorithms for care actions;        2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services          (LAC-DHS) clinics to test the interventions;        3. Use mixed-method evaluation to assess the extent of the implementation of the          interventions, the acceptance to the providers and to the patients, and the impact on          adoption of depression screening and treatment management over time, utilization, and          cost of healthcare services, and patient health outcomes; and        4. Conduct a cost-effectiveness analysis of the three study arms. Successful completion of          the study will demonstrate which Comparative Effectiveness Research (CER) adoption          strategies are successful and why, their comparative cost-effectiveness, as well as          which strategies are successful under which circumstances to inform system-wide          implementation of same.      Hypotheses of the Proposed Study      The following are the main hypotheses of the study:        1. There will be statistically significant difference in the adoption of depression care          screening and management over time among the three study groups.           1.1. The adoption rate will be Technology-supported care (TC) > Supported Care (SC) >          Usual Care (UC).        2. There will be statistically significant difference in the depression symptom reduction,          and better functional status, and quality of life among the three study groups.           2.1. The difference between the TC and the SC will not be statistically significant, but          both will be greater than the UC group.        3. There will be statistically significant difference in the diabetes care process and          outcomes among the three study groups.           3.1. The difference between the TC and the SC will not be statistically significant, but          both will be greater than the UC group.        4. There will also be statistically significant differences in healthcare utilization among          the three study groups, with least utilization in the TC group where the greatest level          of technology is applied.        5. Of the three groups compared, the TC group will be the most cost-effective approach for          accelerating adoption of the CER depression care results.   "
114969|NCT01781000|"     The purpose of this study is to reveal the specific effects of computer-aided cognitive     training on cerebral reorganization in schizophrenia   "
114970|NCT01780987|"     The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE     subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as     initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total     treatment period is 24 weeks)   "
114971|NCT01780974|"     The primary aim of the pilot study is to provide data that can be used to better determine     sample size for the design of a larger clinical trial. The pilot will evaluate the     effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing     Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment     rate, safety, and compliance over the 12 month study period.   "
114972|NCT01780961|"     To create an esophageal cancer biospecimen repository that will collect, annotate, store and     distribute human esophageal cancer biospecimens in a manner that embraces the highest ethical     standards of human subject's research, that conforms to the best practices of biorepository     science and that furthers basic, translational and clinical research in the understanding     diagnosis and treatment of this disease.   "
114973|NCT01780948|"     Hypothesis : In renal transplantation recipient who received immunosuppressive drug     certican and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase     inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily     3A4 both, so investigator made the hypothesis that when patients received everolimus with     atorvastatin will change area under the time concentration curve of everolimus.   "
114974|NCT01780935|"     This study will evaluate and compare two individualized ranibizumab treatment regimens in     patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual     function benefit, while aiming to avoid unnecessary intravitreal injections.      The results will be used to generate further recommendations on functional and anatomical     monitoring of the disease and timing of treatment administration for patients with     neovascular AMD. In this context, the study will investigate the utility of optical coherence     tomography (OCT) to aid retreatment decisions with ranibizumab.   "
114975|NCT01780922|"     The purpose of this study is to determine the effects of a single dose of cranberry beverage     in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites,     and antioxidative and anti-inflammatory activity.   "
114984|NCT01780805|"     This study involves completion of questionnaires, computer-based cognitive tasks and an     alcohol drinking session. Participation in this study consists of an initial, in-person     screening appointment, 4 brief daily appointments at the research office, an alcohol drinking     session at a local bar and a follow-up appointment 1-3 days after the alcohol drinking     session.      Participants who are found to be eligible in the screening phase will then complete a daily     appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on which     they will not attend an appointment). Each appointment will last 20 minutes, on average and     consist of a questionnaire and computer-based cognitive task. On the day of the fourth     appointment, participants will complete an alcohol drinking session. The alcohol drinking     session begins at 4pm and lasts until at least midnight.      Participants in this study will be young adults between the ages of 21-25, who regularly     drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two     participants will complete this study.   "
115104|NCT01779232|"     The purpose of this study is to determine whether pre-treatment with danazol for at least 4     months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.   "
114976|NCT01780909|"     Aim of the study The aim of this study is to use Gabbroral® oral tablet formulation as marker     for the evaluation of the gastrointestinal transit. By collecting and analyzing both gastric     and intestinal fluids on different time points, the transfer dissolution can be distracted.     For this study stomach fluid and intestinal fluid will be collected after oral intake of a     commercially available dosing form of Paromomycin Sulfate (Gabbroral® oral tablet     formulation), which is dissolved in a glas of 240mL water, in fasted or fed state. Four     intake conditions will be tested on four different test days (with an intermediate period of     at least 7 days).        1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL          water, in fasted state.        2. intake of Gabbroral® oral tablet formulation in fed state.        3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the intake          of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.        4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the intake          of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.      Conduct of the study        -  The study consists of four testing days in the University Hospitals Leuven, Gasthuisberg          campus.        -  On each test day you come at the agreed time in fasting State to the Gastroenterology          Department at UZ Leuven (Gasthuisberg, floor 0, Orange arrow). Fasted state means that          you have eaten nothing for 12 hours for the investigation and only have been drinking          water.        -  A basic clinical anamnesis will be taken by a doctor to make sure that you are a healthy          volunteer for our study. For making sure that you are HIV negative, you will undergo an          HIV test. In case of a female volunteer, a pregnancy test will be taken in account to          make sure you are not pregnant.        -  Upon arrival at the hospital through the nose or the mouth two probes: one in the          stomach and one in the gut. The position of both probes is controlled using fluoroscopy          (x-ray).        -  After a stabilisation period of ca. 20 min you will be asked for taking a single dose of          Gabbroral® oral tablet formulation. On four different test days, with an intermediate          period of at least 7 days, we will follow every one of following intake conditions:             1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of               240mL water, in fasted state.             2. intake of Gabbroral® oral tablet formulation in fed state.             3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the               intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of               240mL water.             4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the               intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of               240mL water.        -  After intake of the medicine at regular intervals, gastrointestinal fluids will be          aspirated over 4 hours. You sit in a comfortable position in bed; eating and sleeping is          not permitted (after 2 hours you have the possibility to drink some water).        -  After 4 hours, the gastrointestinal catheters will be removed and you may eat and roam          freely.   "
115297|NCT01776697|"     A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic     characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as     a pelubiprofen 90 mg) tablet QD in healthy subjects.   "
114977|NCT01780896|"     The purpose of this study is to evaluate visual and nonvisual topographic memory impairment     and its relationship to vestibular function in humans. Topographic memory refers to the     ability to remember current and past locations in topographic (navigational) space and to     make and/or adjust to spatial transformations using such memories. Performance on each of     these topographic memory tasks will be compared to performance on a set of comparable     nontopographic memory tasks. Topographic impairments represent some of the earliest cognitive     deficits observed in Alzheimer's Disease, and the brain areas involved in topographic memory     are the first to show degenerative changes.   "
114978|NCT01780883|"     Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in     central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in     autistic disorder suggest abnormalities in melatonin secretion.      Several studies have reported a decrease in melatonin secretion in individuals with autism.     Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin     metabolite) was significantly negatively correlated with severity of autistic impairments in     verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep     problems and may play a role in the pathophysiology of autistic disorder.      These data highlight the possible therapeutic interest of an oral administration of melatonin     in patients with autistic disorder. Thus, the objective of this clinical trial is to study     the relation between the melatonin dose administered and its effect on severity of autistic     impairments especially in verbal communication and play.   "
114979|NCT01780870|"     The main purpose of this study is to assess factors mediating the changes in insulin     sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as     well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.      The investigators will also study the following:        1. The impact of diet induced weight loss on hormones/adipokine levels        2. The impact of diet induced weight loss on leptin tolerance   "
114980|NCT01780857|"     This study is being done to learn more about a less common type of psoriasis, called     palmoplantar pustulosis (PPP). The majority of the current treatments used for this type of     psoriasis have only a moderate effect on PPP. Thus, the investigators believe that PPP may be     a different disease entity altogether, requiring different therapies. As such, the     investigators hope to discover an immune signature for this condition.      An immune signature is the unique way in which the combination of genes, cells, and     proteins of the immune system work for each person. Because both psoriasis and the type of     psoriasis patients have been diagnosed with, PPP, are conditions of abnormal immune system     function, it is important to understand the overall function of the immune system in this     condition (that is, find the immune signature). This study should help identify an immune     system signature in people with PPP.      The investigators have a laboratory technology which allows them to read the genetic     signatures of a person's blood cells. Genes contain the instructions for making living     things. Genes are contained in the cells' DNA (deoxyribonucleic acid). Most DNA is the same     among humans, but the small differences people have in their DNA may explain why people     develop different diseases. DNA and the genes it contains help produce RNA (ribonucleic     acid), which in turn helps make proteins in people's cells. Differences in the types of     proteins and the amount of those different proteins people's cells produce can affect a     person's immune system.      To help the investigators determine the immune signature in PPP, they will be examining the     different genes, cells, and proteins that are active in patients with PPP versus patients who     do not have the condition. The investigators will examine these genes, cells, and proteins in     skin (through a skin sample) and in blood (through a blood draw). The goal is to develop new     treatments for this skin condition. To do this, the investigators need to compare the skin     and blood of patients with this particular type of psoriasis to the samples of healthy     patients.   "
114981|NCT01780844|"     The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40     monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation.     This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate     mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care     immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition,     the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and     steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen     (basiliximab induction + tacrolimus + MMF + steroids).   "
114982|NCT01780831|"     This study will evaluate the safety and pharmacokinetics (PKs) of raltegravir (RAL) given to     HIV-1-exposed newborn infants at risk of acquiring HIV-1 infection. (Pharmacokinetics are the     various interactions between a drug and the body.) This study will also evaluate the     appropriate dose of RAL to give to an infant to prevent the infant from getting HIV infection     from its mother.   "
114983|NCT01780818|"     Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water     Immersion (WI), characterized by suction removal of the infused water predominantly during     the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction     removal of infused water predominantly during the insertion phase of colonoscopy. Several     studies showed that WE significantly reduces pain compared to WI and colonoscopy with     traditional air insufflation (AI), increases the number of unsedated procedures and adenoma     detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a     direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the     hypothesis that WAC (particularly WE) would significantly decrease pain score during     colonoscopy in average-risk screening patients. Several other secondary outcomes will also be     analyzed.   "
119425|NCT01722734|"     A randomized controlled trial was conducted to assess the effectiveness of text reminders     sent to ACT users through an automated text messaging system short-message-system.      Study hypothesis: text message reminders increase adherence   "
114985|NCT01780792|"     Dance Dance Revolution (DDR) may offer an innovative and highly effective format for     delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging     and interactive video game that requires players to move their feet to targets while matching     the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive     training, is an ideal intervention for improving cognitive functioning in those with MS. The     purpose of this pilot study is to examine the use of DDR as a novel and highly specific     exercise intervention to improve mobility and cognition among individuals with MS.   "
114986|NCT01780779|"     The purpose of the study was to investigate whether functional MRI imaging (diffusion     weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in     children and young adults. All patients will be scanned before, during and after     chemotherapy. The findings on MRI will be correlated with histological finding after surgery.      Second purpose : to define apparent diffusion coefficient value of the bone sarcoma.      Third purpose : to try define prognostic factors, to investigate if there is a correlation     between early treatment response and outcome.   "
115298|NCT01776684|"     To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer     harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR     method.   "
114988|NCT01780753|"     The weight of malaria falls most heavily on young children and pregnant women but studies of     the safety of antimalarials in pregnancy and lactation are few. The only recommended     medication used for radical treatment of P.vivax is primaquine. The 2010 WHO malaria     guidelines recommend its use in all patients with P.vivax infection in areas of low     transmission, in the absence of contraindications. Primaquine is contraindicated in     pregnancy. The postpartum period presents a key opportunity to definitively treat women who     suffer multiple malaria relapses during pregnancy. The 2010 WHO malaria treatment guidelines     allow for primaquine use during lactation but there are no studies to date quantifying     primaquine excretion in breast milk and the dose that breastfed infants would be exposed to     is unknown. The investigators propose to study the pharmacokinetics of primaquine in maternal     and infant plasma and in breast milk during a 14 day radical treatment of P.vivax.      Some inferences about the expected behavior of primaquine in lactation can be drawn from its     known pharmacologic properties. Primaquine pharmacokinetics have been well characterized in     healthy subjects and malaria patients after single and multiple oral dosing. Peak     concentrations are reached within 2-3 hours after dosing and the plasma elimination half-life     is ~7 hours. It is extensively distributed in the tissue and largely metabolized to inert     carboxyprimaquine, the major plasma metabolite, which undergoes further biotransformation to     unknown metabolites that are probably more toxic than the parent compound. The identification     of other metabolites in humans has been difficult to pursue because the expected aminophenol     metabolites are unstable.      No pharmacokinetic studies have been done to measure primaquine excretion in breast milk. A     few studies have been done of other antimalarials during lactation and have shown low levels     of drug in breast milk during treatment.   "
114989|NCT01780740|"     Patients with coronary artery disease are often prescribed drugs called statins because     research has shown that, by lowering cholesterol, they reduce the risk of having a heart     attack or other complications in the long-term. Experimental studies have suggested that     statins may also have rapid anti-inflammatory, anti-oxidant and anti arrhythmic actions;     however, whether these effects are of any benefit to patients remains to be proven. The     purpose of STARR trial (Statin Therapy in Atrial Refractoriness and Reperfusion injury) is to     evaluate whether a short course of a commonly used statin (atorvastatin, 80 mg once a day)     decreases inflammation and stabilises electrical properties of the upper chamber of the heart     in the post operative period of patients undergoing cardiac surgery on the heart-lung machine     either for valve replacement and/or coronary artery bypass grafting. It will also examine     whether this treatment can protect the heart from sustaining tissue damage when blood supply     is restored after a period of ischaemia during the course of the surgery.In addition it will     also explore the impact of this intervention on biology of the vessels used for bypass     surgery and the fat tissue in the vicinity of the heart & blood vessels.   "
114990|NCT01780727|"     Elderly patients are the fastest growing surgical population and present with increased risk     of postoperative cardiac problems, especially congestive heart failure. Diastolic dysfunction     is common in the elderly population and increases the risk of major adverse cardiac events     after surgery. This project will use dynamic measurements of diastolic filling pressures by     echocardiography for goal-directed fluid and drug management during surgery to determine     whether this reduces serious cardiac events related to diastolic dysfunction after surgery in     this high-risk population.   "
114991|NCT01780714|"     The goal of this exploratory study is to evaluate the effect of a candidate modified risk     tobacco product (MRTP), THS 2.1, on selected biomarkers of exposure to harmful and     potentially harmful smoke constituents (HPHCs), compared to conventional cigarettes (CC). The     subjective effects (urge to smoke and withdrawal symptoms) which are related to the use of     this product will be explored. Initial information on safety and on some biological effects     when using THS 2.1 will be collected. Human Smoking Topography (HST) will be explored.   "
114992|NCT01780701|"     A prostate cancer diagnosis starts a list of events that often leads to fast-moving     treatment, thought by many to result in vast over-treatment of this disease. So, discovery of     different diagnostic methods that allow clinicians to identify slow-growing from potentially     fast-growing disease prior to or at the time of prostate biopsy could result in early and     suitable treatment for men at greatest risk, while greatly decreasing the number of biopsies,     surgical procedures, hormonal and chemotherapeutic treatments, cost, and patient worry, for     those with more slow-growing disease.   "
114993|NCT01780688|"     The main goal of this exploratory study is to evaluate the pharmacokinetic profile of     nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional     cigarettes (CC).   "
114994|NCT01780675|"     Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard     dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low.     However, a clear relationship between radiation dose and damage to the hippocampal stem cells     has not been established yet.      This study is initiated to investigate the early and delayed neurotoxicity of PCI and to     assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell     Lung Cancer patients who receive PCI.   "
115004|NCT01780545|"     This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of     Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense     oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to     docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma (UC)     that are relapsed or refractory after receiving a platinum-containing regimen.   "
114995|NCT01780662|"     This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when     given together with gemcitabine hydrochloride and to see how well they work in treating     younger patients with Hodgkin lymphoma that has returned or does not respond to treatment.     Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill them.     Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop     the growth of cancer cells, either by killing the cells or by stopping them from dividing.     Giving brentuximab vedotin together with gemcitabine hydrochloride may kill more cancer     cells.   "
114996|NCT01780649|"     Intracytoplasmic Morphologically Selected Sperm (IMSI) is a modification of IntraCytoplasmic     Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x     magnification instead of 400x commonly used in ICSI. The purpose of this study is to evaluate     the efficiency and the indications of IMSI through a multicentric randomised trial.   "
115105|NCT01779219|"     Background: The aim of the study was to assess the safety and effectiveness of stereotactic     brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison     with its frameless classic analogue based on a prospective randomized trial.      Patients are prospectively randomized into a low-field iMRI group and a control group that     undergo a frameless STx biopsy. The primary endpoints of the analysis are: postoperative     complication rate and diagnostic yield, and the secondary endpoints: length of hospital stay     and duration of operation.   "
114997|NCT01780636|"     Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that presents     with chronic constipation, anismus, or a sensation of incomplete rectal emptying. The     specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown, but it     is estimated that 4% of patients with defecatory disorders have NRPS. Previous therapies for     non-relaxing PRS have included biofeedback, pelvic floor physical therapy, dietary changes,     laxatives, enemas, and surgical division of the puborectalis muscle. Unfortunately, responses     to these treatments have been variable at best. Direct injection of botulinum toxin (Botox)     into the puborectalis muscle is an alternative approach for treating NRPS and has recently     been reported in a limited number of studies. Botox blocks cholinergic nerve endings in the     autonomic nervous system and has been used to weaken the puborectalis muscle in constipated     patients.      Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into     the puborectalis muscle in women with NRPS. With use of this technique, we believe we will     find that Botox injections decrease symptom severity and improve quality of life (QOL) in     patients with NRPS.      We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox     injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox     injection into the puborectalis muscle in patients with NRPS.      All enrolled patients will receive ultrasound and EMG guided Botox injections at three points     along the puborectalis muscle. Post-injection data will be obtained with a defecation diary     and questionnaire data at the 2-week, 3-month, and 6-month intervals. Additional injections     will be offered to patients who fail the initial treatment.   "
114998|NCT01780623|"     Cancer-related fatigue is one of the most common and distressing symptoms associated with a     cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during     treatment, and lasts for years after treatment in up to 35% of patients. Despite the     long-term effects of cancer-related fatigue, the treatment options available are not always     appropriate or helpful for all patients.Light therapy is an effective treatment for other     disorders related to fatigue. The purpose of the study is to investigate the role of light     therapy on quality of life, sleep patterns, and physical measures of immune function and     stress hormones in individuals with post-treatment cancer-related fatigue.   "
114999|NCT01780610|"     There are two main cycle regimens used for endometrial preparation for frozen embryo transfer     （FET) in women with irregular cycles: hormone replacement therapy cycles (HRT) in which the     endometrium is artificially prepared by estrogen and progesterone hormones with/without a     gonadotrophin releasing hormone agonist (GnRH-a) down regulation, and ovulation induced     cycles (OI) in which follicular development is supported with increasing doses of     gonadotrophin hormones and ovulation is induced. At present, there is still no sufficient     evidence that which kind of frozen embryo transfer cycle regimen to plan more advantage. The     purpose of this study was to compare the pregnancy outcome of hormone replacement therapy     cycles (HRT) and ovulation induced cycles (OI) in women with irregular cycles.   "
115000|NCT01780597|"     The main question to be asked in this study is what is the potential for human hearts that     have been deemed unacceptable for transplant, to be explanted and re-animated in a     controlled, external environment to be assessed? Furthermore would the reanimated hearts be     able to undergo improvement in their function in this external environment.      Ultimately this may lead to an increase the number of hearts available for transplantation.   "
115001|NCT01780584|"     Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill.     This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary     bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing     Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation     for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was     known effective in maintaining T3 levels during pediatric cardiac surgery. This drug     preparation however is not commonly used in many countries due to the relatively high costs     and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3     levels in pediatric patients has not been reported so far, although recent adult studies     showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to     determine if oral T3 supplementation could prevent the decline of serum T3 in children less     than 2 years of age undergoing congenital heart surgery using CPB.   "
115002|NCT01780571|"     The purpose of this study is to determine whether continuouse positive airway pressure     (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels     of oxygen in the blood.   "
115003|NCT01780558|"     There are three main cycle regimens used for endometrial preparation for frozen embryo     transfer（FET）: natural cycles (NC) with/without ovulation triggering, hormone replacement     therapy cycles (HRT) in which the endometrium is artificially prepared by estrogen and     progesterone hormones with/without a gonadotrophin releasing hormone agonist (GnRH-a) down     regulation, and ovulation induced cycles (OI) in which follicular development is supported     with increasing doses of gonadotrophin hormones and ovulation is induced. At present, there     is still no sufficient evidence that which kind of FET cycle regimen to plan more advantage.     The purpose of this study was to compare the pregnancy outcome of NC-FET to that of HRT-FET     in women with regular cycles.   "
115005|NCT01780532|"     After locating the suspicious lesion/mass with standard of care mammography and/or     ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located.     After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram     and ultrasound only).   "
115021|NCT01780324|"     Primary Aim      1. To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC)     Pain Scale score at the time of transurethral bladder catheterization for urine collection in     children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.      Secondary Aims        1. To assess gender differences in pain control during transurethral bladder          catheterization with and without pain control using intraurethral 2% lidocaine jelly.        2. To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.           To assess parental impression of discomfort between intervention and control groups.        3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly.        4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the          time of TUBC for urine collection in children who do and do not receive intraurethral 2%          lidocaine jelly prior to catheterization.   "
115010|NCT01780467|"     Use lay language.      Many decisions involve the possibility of gaining or losing relative to the status quo. The     loss aversion behaviour is a cognitive concept explaining that people are more sensitive to     the possibility of losing objects or money than they are to the possibility of gaining the     same objects or amounts of money.      We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight     this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary     purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by     comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when     they are exposed to mixed (gain/loss) gambles using money.      The second purpose is to highlight the role of a dopamine depletion by comparing patient     without treatment vs healthy paired control.      2 groups :        -  20 parkinsonian patients (tested two times : with and without treatment by L dopa)        -  20 healthy paired control      Description of the protocol for patients :      J0 : Inclusion visit (duration : 4h):        -  motor assessment (UPDRS)        -  neuropsychological and psychiatric assessment (MMS, MATTIS, BREF, Stroop, Ardouin scale,          UPPS, MADRS, Hamilton, LARS).      J0+1 day and J0 +2 days : 2 visits of MRI (magnetic resonance imaging) acquisition (with or     without treatment) :      Each acquisition was composed by an orientation sequence+ an anatomic sequence + a functional     sequence.      For healthy subjects, they have only one visit of 2 hours including a MMS, a MADRS and the     MRI acquisitions.   "
115011|NCT01780454|"     This study will examine the safety and effectiveness of a combination kidney and bone marrow     transplant from a haplo-identical related donor. An investigational medication and other     treatments will be given prior to and after the transplant to help protect the transplanted     kidney from being attacked by the body's immune system   "
115012|NCT01780441|"     The investigators are enrolling 3-12 month old infants with a diagnosis of tuberous sclerosis     complex (TSC) for a new study on early markers of autism. The study is looking for early     signs for autism in a population (TSC) where autism is common. The goal of this project is to     use behavioral testing, MRI and EEG techniques to identify children at risk for developing     autism starting at 3 months of age and continuing until 36 months of age. Throughout the     study, the investigators will recommend Early Intervention services for any child who shows     early signs of autism.   "
115013|NCT01780428|"     This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of     CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to     severe pain following surgical removal of impacted third molar teeth.      A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was     included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also     evaluated to placebo for the relief of pain.   "
115014|NCT01780415|"     The objective will focus on the characterization of DNA fragments present in Blastocoele     fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic     Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and     -subsequently- Next Generation Sequencing and aCGH approaches will be used.   "
115015|NCT01780402|"     The purpose of this study is to test three hand feeding techniques that can be used to     provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand     feeding, and hand-under-hand feeding.   "
115016|NCT01780389|"     The current study examines the effects of milnacipran in patients who have chronic persistent     knee pain one year or longer after total knee arthroplasty (TKA) to evaluate for a     pain-relieving effect.   "
115017|NCT01780376|"     Whole Body Vibration (WBV) applies thrust force in opposite direction to gravity to body.This     mechanical stimulation induces reflex muscular activity. Tonic vibration reflex (TVR) is most     commonly cited mechanism to explain WBV-induced reflex muscular activity (WBV-IRMA), although     there is no conclusive evidence that TVR occurs. The bone myoregulation reflex is another     neurologic mechanism used to explain the effects of vibration on muscular performance.      Investigators hypothesized that latency of WBV-IRMA is different from latency of TVR. Primary     aim of this study is to determine latency of WBV-IRMA. Secondary aim is to investigate     whether WBV-IRMA is explained with TVR.      Twenty healthy young adult men are planned to include in this study. Participants will stand     upright with their knees locked during WBV. PowerPlate Pro5 will be used for WBV. WBV with     high amplitude at 25,30,35,40,45 and 50 Hz will be applied. Surface electrodes will be placed     on both the soleus muscles. To measure TVR latency, piezo-electric accelerometer will be     placed on the achilles tendon and this achilles tendon will be stimulated with spring based     mechanical reflex hammer. Our pilot study was showed that motor unit potentials (MUAP)     occurred in a 1:1 response with vibration. After confirmation of this finding, WBV-IRMA     latency will be measured in the present study. To measure WBV-IRMA latency, piezo-electric     force sensor will be placed between heel and WBV platform. Exact moment of initial strike of     heel when thrust force expressed by WBV begin to be transferred to body will be determined.     The time between moment of the initial strike and corresponding MUAP is defined as WBV-IRMA     latency. Piezo-electric stretch sensor will be placed between knee and malleol to simulate     muscle spindle. The reflex muscle activity of soleus muscles will be measured by PowerLab     (data acquisition system, ADInstruments, Australia) device.      This project is planed to be completed in 1 months.   "
115018|NCT01780363|"     Background: Genetics is suggested to play a critical role in the development of Behçet's     disease (BD). Shared phenotypic features requires an approach to the differential diagnosis     from periodic febrile syndromes particularly from mevalonate kinase deficiency related     diseases. We planned to study for evaluating the frequency of mutations and their clinical     significance in mevalonate kinase gene in Turkish patients with Behçet's disease.   "
115019|NCT01780350|"     This study is attached to a comprehensive quality assurance/quality improvement (QA/QI)     program conducted by the Office of the medical director, and is designed to contribute to     generalizable knowledge to determine effectiveness and tolerability of an FDA approved     Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS)     system. The cohort will comprise a convenience sample of patients that are being treated by     EMS for a hypotensive emergency.   "
115020|NCT01780337|"     In this pilot study the investigators will perform a double-blind randomized trial of     intranasal oxytocin on measures of cardiac refractoriness, among individuals who are     undergoing clinically indicated catheter ablation procedures for paroxysmal atrial     fibrillation. The investigators seek to enroll 20 patients for this study, for the purpose of     estimating effect sizes for a larger future study.   "
115169|NCT01778387|"     The purpose of this prospective paper is to make a comparison between laparoscopic and     opening approaches in ventral hernia repair, taking into account absence of recurrence in     long - time (5 years), results centered at patient, especially satisfaction with expectations     and improvement of normal physical activity, morbidity that particular form must include     chronic pain, adjusted mortality through co-morbidities and, finally, prospective expenses,     related to both effectiveness and utility   "
115023|NCT01780298|"     Chronic obstructive pulmonary disease (COPD) is a common inflammatory disease of the airway     affecting approximately 10% of individuals aged 40 years or more with a smoking history. The     disease is characterized by an increase in numbers of airway white blood cells (neutrophils,     lymphocytes and monocytes). Stimulation of white blood cells results in the release of     different agents of inflammation. Some of these agents give an indication of the presence or     severity of a disease when measured.      This case control study will be conducted at The Heart Lung Centre, London, UK. The study     aims to determine biomarkers for the differentiation of subjects with COPD (GOLD Stage 1-2     and who are current smokers with a ≥ 10 pack year smoking history) and three matched control     groups: one of non-smoking subjects (never smoked), one of ex-smokers and one of current     smokers. COPD subjects will be matched to the non-COPD subjects by gender, age and ethnicity.      The study will include a range of physiological measurements including lung function,     computerized tomography scans (CT scans), cardio pulmonary exercise test and computerized     multichannel lung sounds analysis (Stethographics). In addition, lung inflammation will be     assessed by cellular and molecular biomarkers using e.g. transcriptomics and proteomics     technologies.   "
115024|NCT01780285|"     This study is prospective randomized trial enrolling at least 50 participants which compares     efficacy and safety of two alternative methods of laparoscopic hiatal repair for giant (i.e.     with hiatal surface area (HSA) exceeding 20 sq.cm) types II and III hiatal hernias: partially     absorbable lightweight mesh repair, and nitinol-framed lightweight polytetrafluoroethylene     (PTFE) mesh repair. In the literature, mean rate of anatomical recurrence of giant hiatal     hernias is 25 %, reaching 42 %. Polypropylene and composite PTFE meshes used most widely,     result in unacceptable rates of long-term dysphagia (10-15 %) and oesophageal strictures. Own     experience of the interventors of more than 400 repairs using partially absorbable     lightweight mesh Ultrapro (Ethicon) and original sub-lay technique of its fixation precluding     contact of the mesh with the oesophagus, showed low recurrence rate for large hernias and a     few cases of long-term dysphagia. For giant hiatal hernias, this technique provides     acceptable results (20 % of recurrence) which correspond to the literature. Nevertheless,     these results may be improved, probably by using of new type of prosthesis. Thus, in     collaboration with Minnesota Medical Development, Inc., USA, the interventors created     fundamentally new method of hiatal repair by using new prosthesis - Rebound HRD-Hiatus     hernia. This prosthesis is heart-shaped lightweight PTFE mesh with peripheral nitinol frame.     It is easily fixated to the crura posteriorly to the oesophagus completely covering hernia     defect, and supports a strong framework of the hiatus, and, therefore, allows to save a     principle a real tension-free repair. Mid-term results (mean follow-up period of 15 months)     of 29 procedures showed no recurrences or oesophageal complications. Naturally, final     conclusions regarding superiority of the new technique could be established by prospective     randomized study. The hypothesis of the current trial is: new method of nitinol-framed     lightweight PTFE mesh repair is more effective in terms of recurrence rate compared to     sub-lay partially absorbable lightweight mesh repair, and is characterized by at least     similar safety in terms of oesophageal complications. The long-term results (24 months post     surgery for every patient) will be studied using symptom questionnaires, quality of life and     satisfaction questionnaires, barium studies, endoscopic examinations, 24-hour pH testing, and     analysis of possible reoperations.   "
115025|NCT01780272|"     This trial is conducted in Europe. The aim of this trial is to investigate the impact of low     blood sugar during the night on sleep in subjects with type 2 diabetes.   "
115026|NCT01780259|"     The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to     the medication) of intranasally (through the nose) administered esketamine in healthy     participants.   "
115027|NCT01780246|"     The primary objective of this study is to examine the safety and tolerability of nusinersen     (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA)     who previously participated in ISIS 396443-CS1 (NCT02865109). The secondary objective was to     examine the plasma pharmacokinetics of a single dose of ISIS 396443 administered     intrathecally to participants with SMA who previously participated in ISIS 396443-CS1.   "
115028|NCT01780233|"     The objective of this study was to compare the rate of absorption and bioavailability of     fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate     injection 100 µg intravenously.   "
115029|NCT01780220|"     As there is no prospective data on the combination of abiraterone and salvage radiotherapy,     the aim of this study is to further evaluate the safety profile of abiraterone acetate plus     prednisone in patients with prostate cancer who are biochemically relapsing after surgery and     undergo salvage radiotherapy with 6-months LH-RH agonist.      The investigators hypothesize that the toxicity profile of both treatments should not     potentiate each other. This study will also provide preliminary data on the efficacy of this     combination.   "
115030|NCT01780207|"     The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant     patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal     hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function     and arterial stiffness.   "
115031|NCT01780194|"     -  To determine the effect size of lumbar fusion measured by Oswestry Disability Index and          compared with conservative treatment in patients with chronic low back pain.        -  Meta-analysis using fixed effect model synthesis method.        -  Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.   "
115032|NCT01780181|"     The purpose of this study is to observe the efficacy of chemotherapy combined with     Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer,     also to evaluate the adverse reaction and the reliability.   "
115208|NCT01777867|"     The aim of this study is to provide pilot data on the possible gastrointestinal predictors of     respiratory hyper-responsiveness and how these relate to the clinical sub-types of     gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.   "
115039|NCT01780090|"     The proposed study will result in a software application compatible with the Apple iPad,     iPhone and iPod Touch (hereafter termed iOS devices) which addresses several aspects of     prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other     communication disorders, using a developmentally appropriate, intuitive interface that     requires little technical skill and which can be managed by educators and parents. The     program will contain elements that aid in tracking and maintaining individual student     progress records, and will be designed for use in the classroom, at home, and in other     environments. This study's intended focus is on the feasibility and usability of the software     application.   "
115040|NCT01780077|"     The purpose of this trial is to evaluate the safety and tolerability of multiple (3)     intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy     volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be     evaluated visually, histologically, and by biomarker analysis.   "
115041|NCT01780064|"     The purpose of this study is to compare the effect of early individualized psychosocial     assets versus a standard support on social inequalities in the rate of return to work   "
115033|NCT01780168|"     Background:      - Inborn errors of metabolism (IEM) can affect how the body s immune system functions. People     with IEM also have special dietary restrictions that may affect the function of their immune     system. Researchers want to better understand how having an IEM may affect immune system     function.      Objectives:      - To study the how having an IEM may affect immune system functioning.      Eligibility:        -  Individuals at least 2 years of age who have an IEM.        -  Healthy volunteers at least 2 years of age.      Design:        -  Participants will come to the NIH Clinical Center for at least 1 evaluation. Depending          on the level of participation, participants may return for additional visits. All          participants (or their parents) must keep a detailed food diary for 3 days before the          initial visit.        -  At the study visit, participants will provide blood samples. Females of childbearing age          will provide a urine sample.        -  Participants will be offered the hepatitis A vaccination if not already given. If the          visit occurs during flu season (roughly September through March), they will be offered a          seasonal/H1N1 influenza vaccine.        -  Children between 2 and 8 years of age may require booster shots depending on their          history of vaccination.        -  At a follow-up visit(s), participants will provide additional blood samples.        -  Participants may return yearly for their flu vaccine.   "
115034|NCT01780155|"     Background:      - Some premature babies develop bronchopulmonary dysplasia (BPD) and retinopathy of     prematurity (ROP). BPD and ROP are long-term chronic diseases of the lungs and eyes,     respectively. BPD is associated with receiving mechanical ventilation to treat respiratory     distress syndrome, and causes lung inflammation and scarring. ROP is caused by poor     development of blood vessels in the eyes, and may lead to blindness. Because not all     premature babies develop BPD or ROP, researchers want to study the genes that could be     associated with these diseases. They will look at both premature infants and their parents to     see if there is a genetic component to BPD and ROP.      Objectives:      - To study genes that may be associated with BPD and ROP.      Eligibility:        -  Premature babies born with a weight less than or equal to 1,250 grams.        -  Parents of the premature babies.      Design:        -  Parents will answer questions about the mother s health and pregnancy.        -  Delivery and medical information will be collected during the baby s hospitalization for          the first month after birth.        -  Parents will provide a saliva sample from the inside of the cheek.        -  A saliva sample will also be collected from the baby within 28 days of birth. If the          baby needs tracheal aspiration (removal of fluid from the throat), tracheal fluid          samples will also be collected.        -  Parents will have followup interviews about their child s health 6 months, 12 months,          and yearly for up to 6 years after birth.        -  This is a genetic study only. Treatment will not be provided as part of this study.   "
115035|NCT01780142|"     Background:      - Asthma is a lung condition that causes difficulty breathing and decreased lung function.     Some people with asthma have more severe disease symptoms. They may be less responsive to     standard treatments such as steroids. Researchers want to compare severe asthmatics with mild     or moderate asthmatics or people without asthma over a long period. This information may help     identify new treatments for people whose asthma is not well controlled by standard     medications.      Objectives:      - To compare severe asthmatics with mild or moderate asthmatics, and healthy volunteers, to     study the progression and outcomes of the disease.      Eligibility:        -  Individuals at least 18 years of age who have been diagnosed with asthma for at least 1          year.        -  Healthy volunteers at least 18 years of age.      Design:        -  This study will involve an initial visit to the NIH Clinical Center for all          participants. Selected participants may be asked to return for repeat visits over a          number of years. The test results from participants with asthma will be compared with          those from the healthy volunteers.        -  All participants will be screened with a physical exam and medical history.        -  Participants may (but will not necessarily) have the following tests at each visit:        -  Complete medical history and physical exam        -  Blood, urine, sputum, and nasal cell samples        -  Breath tests and heart and lung function tests        -  Six-minute walk test to measure ability to exercise        -  Imaging studies such as chest x-rays, bone density scans, and sinus scans        -  Allergy skin testing        -  Vocal cord exam        -  Overnight sleep study        -  Participants may remain on the study for as long as they are willing to participate and          do not develop health problems that will interfere with the study.   "
115036|NCT01780129|"     HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac     function, improves microcirculation, and increases blood pressure and pulse pressure, and     improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined     multiple target pharmacological effects.      Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock     patient.      This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin     Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with     traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with     systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure     stabilization, regardless the types of completed, on-going, or projected Standard of Care or     surgery will be recruited to participant in the trial. A total of 120 patients with     traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each     type of shock, sixty patients each will be in test group and control group. Both adult males     and females aged 18-80 years are eligible. The primary clinical endpoint is the time length     (TL) between the start of HW6 administration to the onset of the first treatment success,     that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour     without the use of vasopressors. Several secondary endpoints and biomarkers will be measured.      Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment     groups and placebo groups. Safety data will also be reported accordingly.   "
115037|NCT01780116|"     When compared with those in the control (usual care) group, participants in the AT group are     expected to demonstrate significant improvements immediately and at three, six and 12 months     after completion of the intervention in: level of medication adherence, readmission rate,     mental status, insight into treatment, and level of functioning.   "
115038|NCT01780103|"     In this retrospective study the investigators will enroll newborns that were born between     01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of     Pyelectasis according to prenatal sonographic screening test.      These babies underwent renal sonography at the age of 2-5 days according to the protocol and     were invited to an additional renal sonographic screening test at the age of 1 month.      The investigators will compare the results of the 2 examinations and the investigators will     try to reach conclusions whether there is correspondence between the severity of the     pyelectasis in the first and second sonographic tests and the outcome of these newborn babies   "
115232|NCT01777555|"     This randomized, multicenter, placebo-controlled, double-blind study will evaluate the     efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing     motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the     clinic.   "
115043|NCT01780038|"     Innovative strategies to reduce adult smoking prevalence include using genetic information to     motivate cessation and, ultimately, to tailor cessation pharmacotherapy. Success of these     interventions depends, in part, on smokers' interest and participation in genetic testing     related to cessation and their understanding and use of the results (i.e., their genetic     literacy). The recent availability of genetic risk testing for a nicotinic acetylcholine     receptor gene (CHRNA3) variant (rs105173) associated with nicotine dependence makes it highly     feasible to investigate smokers' interest in and use of genetic information about nicotine     dependence. Therefore, the primary purpose of this study is to determine the impact of an     intervention that provides smokers with an educational session about genetic contributions to     smoking and nicotine dependence plus their genotype results for rs1051730 on smoking     cessation outcomes compared to those who receive only the educational session. Secondary     purposes are to determine: (a) the impact of genetic education and knowing personal genotype     results on genetic literacy outcomes and (b) the feasibility of recruitment and retention     methods in a study addressing genotyping for nicotine dependence. Primary outcomes are     cessation-related behaviors and cognitions indicating abstinence. Secondary outcomes are     cognitions and emotions indicating genetic literacy. Knowledge gained from this study has the     potential for clinical translation so that as genotyping becomes part of smoking cessation,     health-care providers can understand and address factors influencing smokers' adaptation to     genetically-informed cessation treatment. The study will use a longitudinal, repeated     measures design (experimental, control; N=90; 45/group). All participants will receive a     90-minute educational session about genetic contributions for smoking and nicotine dependence     and will donate a buccal swab sample for genotyping. The investigators will then randomize     participants to two groups: those who receive genotyping results in a genetic counseling     session (experimental) and those who do not (control). Follow-up data will be collected from     both groups at baseline and weeks 2, 6, 10 after the experimental group receives genotyping     results, with a brief follow-up and study termination occurring at week 12. Control group     participants will be offered their genotyping results at the end of the study.   "
115044|NCT01780025|"     The purpose of this study is to measure objectively the coupling from direct acoustic     cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked     potentials.   "
115045|NCT01780012|"     Osteoporosis is a disease characterized by reduced bone mass and increased skeletal     fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture     is a powerful predictor of future fractures and about 50% of patients with a fragility     fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007).     Osteoporotic fractures are associated with an increased morbidity and mortality but also high     financial costs. However, less than 20% of patients presenting a low trauma fracture receive     an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The     hypothesis of a lack of information and an under assessment of consequences by both patients     and physicians has been raised to explain this gap between recommended care and usual     practices.      The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis     prevention program, after a fragility fracture of the upper limb, to improve post-fracture     management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50     years old.      This open randomized controlled trial aims to compare the BMD or osteoporosis treatment     prescription rate at 6 months after inclusion between two groups: intervention receiving     information on fracture and osteoporosis (oral and written), phone call reminders and written     information to give to their family physician, and control receiving usual care without     information.   "
115046|NCT01779999|"     Background: PICC-related thrombosis have shown a slightly different pattern of frequency and     risk factors, compared with traditional CVC; because of the increasing diffusion of PICCs,     they are becoming a somehow independent pathology, still under investigation; no     pharmacological prevention has proved to be effective. Aim of this study is to estimate the     cumulative incidence of thrombosis in a cohort of patients carrying a PICC-line CVC,     monitored to allow an early detection and prevention of complications related to the presence     of asymptomatic deep venous thrombosis, and to explore the role of several potential risk     factors.      Methods: in a prospective observational cohort we will enroll 150 consecutive patients having     a PICC inserted by our team; clinical characteristics, comorbidities and main features of     catheter positioning procedure will be registered; patients will be followed with clinical     and echographic scheduled controls, weekly for the first month, then monthly; patients with     PRDVT will be treated with LMWH and recontrolled weekly until removal of catheter   "
115047|NCT01779986|"     The use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as     evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and     convention coronary angiogram results in patients who are scheduled for an ascending aorta     aneurysm reparation surgery. These examens are standard of care before this surgery, so there     is no additional danger or disadvantage for the patient. We hope to confirm that CT-AS is a     reliable screening test for CAD in patient undergoing heart surgery for other reason than     CAD.   "
115048|NCT01779973|"     The goal of this project is to test the feasibility, acceptability, and preliminary efficacy     of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate     dependence. To that end, 10 opiate dependent subjects will be recruited through the     University of Pennsylvania's Treatment Research Center, an outpatient substance abuse     treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted     as needed according to individual requirements).   "
125012|NCT01649375|"     This study will assess the efficacy and safety of secukinumab in patients with active     ankylosing spondylitis who are tolerant to or have had an inadequate response to NSAIDs,     DMARDs and / or TNFα inhibitor   "
115049|NCT01779960|"     Up to this moment, the majority of studies assessing the level of physical activity in daily     life in patients with COPD are limited to a cross-sectional design, which does not take into     account natural variation of physical activity in daily life due to differences in climatic     conditions faced throughout the year. Preliminary evidences suggest that patients with COPD     have different physical activity levels according to the seasons of the year. However, the     limited current evidences do not allow us to know the magnitude of differences in the level     of daily physical activity in patients with COPD when taking into account climatic changes     resulting from different seasons of the year in cities and countries with contrasting     climatic conditions. This gap observed in the literature does not allow us at this moment to     know whether we should or not consider the season of the year as one of the main causes of     variability while assessing physical activity in daily life in patients with COPD.      The present project proposes to investigate the hypothesis that patients with COPD who live     in a place with less marked decrease in temperature between summer and winter (Londrina,     Brazil) have less variability in the level of physical activity in daily life through the     year in comparison to patients who live in a place with more marked climatic variability     during these seasons (Leuven, Belgium).   "
115050|NCT01779947|"     The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal     Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the     efficacy of each of the 2 active treatments is superior to that of the placebo.   "
115051|NCT01779921|"     This study is conducted globally. The aim of this study is to describe the treatment     modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor     VII (FVII) deficiency in addition to evaluate the presence (in already treated patients)     and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.      Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use     (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII     (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation     Registry (STER, NCT01269138). These patients can also have been treated with other     haemostatics for systemic administration.   "
115052|NCT01779908|"     Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in     130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants will     have abdominal obesity and at least one factor associated with insulin resistance.     Participants will be randomized by sex, BMI and age. The primary aim is to compare the effect     of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity     (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims     are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism,     the lipid profile, blood pressure and anthropometric measurements. Questionnaires on physical     activity and sunlight exposure, and a food frequency questionnaire will be administered at 0     and 6 mo to adjust for confounding factors. At 0 and 6 mo, changes in serum 25(OH)D will be     correlated with changes in blood markers associated with insulin sensitivity [hs-CRP,     inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated     osteocalcin].      This research project intends to test 2 major hypotheses: (1) that vitamin D deficiency plays     a causal role in the pathogenesis of insulin resistance in humans; and (2) that vitamin D     increases insulin sensitivity.   "
115053|NCT01779895|"     The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the     quality of life in adult subjects suffering from perennial allergic rhinit.   "
115054|NCT01779882|"     The aim of this study is to test the hypothesis, that the order of application of Busulfan     (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem     cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.   "
115055|NCT01779869|"     The objective for this pilot study is to develop an optimized, clinically usable myocardial     PET-MR perfusion protocol and to determine which of all data potentially available should be     acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that     high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion     imaging, significantly decreasing examination time and patient radiation dose while     maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage.      The primary outcome will be comparison of diagnostic accuracy of each combination of imaging     to detect clinically significant coronary artery stenosis (≥70% diameter stenosis). The     secondary outcome will be comparison of confidence for presence of disease among data sets.   "
115056|NCT01779856|"     The primary objective of this study is to estimate the proportion of hemodialysis patients     experiencing clinically significant cardiac arrhythmias over a 6-month period using     continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor     (ICM) device.   "
115057|NCT01779843|"     This research study is a Phase I clinical trial. Phase I trials test the safety of an     investigational drug or combination of drugs. Phase I studies also try to define the     appropriate dose of the investigational drug to use for further studies. Investigational     means that the combination of drugs is still being studied and that research doctors are     trying to find out more about it. As part of this research study, you will take alisertib in     combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for     your cancer. However, cytarabine and idarubicin have both been approved by the FDA for     treatment of AML. It also means that the FDA has not approved giving alisertib with     idarubicin and cytarabine for use in patients, including patients with your type of cancer.      Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals     diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest     that alisertib may slow down the spread of your cancer. It does this by blocking certain     substances needed by the cancer cells to spread. In this study, researchers would like to     combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if     it can be given safely with chemotherapy in individuals with AML.      The primary purpose of this research study is to determine the highest dose that alisertib     can be given with idarubicin and cytarabine without severe or unmanageable side effects. The     dose identified in this study will be used in future research studies.   "
119602|NCT01720420|"     AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium     with Locator attachment and related Overdenture on 4 NobelReplace implants with conical     connection (CC) in the mandible/maxilla.   "
115059|NCT01779817|"     1. MAIN OBJECTIVE :           To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual          development of the child from 6 to 9 years        2. SECONDARY OBJECTIVES :             1. To assess the consequences of a maternal hyperthyroïd during pregnancy on the               capacities of attention, learning process and the degree of hyperactivity of the               child from 6 to 9 years.             2. To study if it exist differences of intellectual development, capacities of               attention, learning process, and degree of hyperactivity in the child from 6 to 9               years, born to hyperthyroid mother during pregnancy, according to:                  -  the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid                    versus disease of Basedow),                  -  the use or not of a anti-thyroid treatment,                  -  the rate of TSH néonatal (measured with the blotter by tracking with J3 at all                    the new born ones).   "
115106|NCT01779206|"     Trial for the optimization of risk assessment and therapy success prediction in patients with     early breast cancer by the use of biomarkers in advance to therapy decision-making to     personalize therapies.   "
115299|NCT01776671|"     Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation.     Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of     this study is to evaluate the accuracy and efficacy achieved in using of extended release     Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical     outcomes postoperatively.   "
115060|NCT01779804|"     Foot and ankle injuries account for nearly two million visits to Emergency Departments (EDs)     in the United States and Canada each year. Of these injured patients, only 15% are diagnosed     with actual fractures of the ankle. Due to such a small percentage, the Ottawa Ankle and     Foot Rules (OFAR) were developed, which are a set of clinical decision-making guidelines     that have been shown to be effective in diagnosing ankle and foot fractures. These rules are     internationally accepted by the medical community, but are inconsistently applied.      At Lehigh Valley Health Network (LVHN), the ED triage nurses are routinely trained in how to     use the Ottawa Ankle and Foot Rules, but the rules are not always applied which may result in     unnecessary X-rays. These guidelines are current network standard of care (usual,     established care) that allow nurses to decide treatment for foot and ankle injury patients;     in other words, whether to send these patients for an X-ray or not.      The research staff is conducting this study in order to find out if using these     nurse-directed guidelines--on a regular and consistent basis--can decrease the number of     X-rays ordered, decrease patient waiting times/length of stay (LOS) and increase patient     satisfaction with their care in the ED.      STUDY PURPOSE:      The two main goals of this study are to find out if use of the Ottawa Ankle and Foot Rules by     triage nurses can decrease the amount of X-rays ordered in the ED, as well as LOS.      Secondary study goals are to: 1) see how many X-rays are ordered by physicians and     physicians' assistants after patients are evaluated by the Ottawa Ankle and Foot Rules as not     having had a fracture; and 2) evaluate patient and provider satisfaction with the care     provided both when the Ottawa Foot and Ankle Rules are used and when they are not.   "
115061|NCT01779791|"     The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib)     administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).   "
115062|NCT01779778|"     The purpose of this research study is to determine the diurnal and nocturnal effects of     Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.   "
115063|NCT01779765|"     This study objective is to assess the short and long term effects of partially hydrolyzed     guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these     patients.   "
115064|NCT01779752|"     In human, the cerebral cortex forms a network of vestibular cortical areas which functional     role remains unknown. In patients with localised cortical lesions the investigator has     previously demonstrated that the parieto-temporal cortex could regulate the inertial     component of the vestibulo-ocular (VOR) responses whereas more ventral regions including the     temporo-occipital cortex would be associated with gain regulation of these VOR responses.      The investigator's main purpose is to investigate the modalities of vestibular integration in     these posterior parieto-temporal et temporo-occipital cortical regions. Thus, by using     repetitive ttranscranial magnetic stimulation (rTMS) the investigator will induce a     transitory inhibition of one of these 2 cortical regions and register its effect on VOR     responses. Based on theta burst stimulation (TBS) paradigm, the investigator will stimulate     the region of interest by applying on the scalp repetitive burst (at 50 HZ) during 44sec.     Then, during the consecutive cortical inhibition lasting for the 15 minutes poststimulation,     the investigator will record the subject's VOR responses. The VOR gain will be calculated and     the time constant and phase will provide an estimation of the inertial component of the VOR     responses. The healthy subjects recruited on the basis of inclusion criteria during medical     examination will be divided into two groups of 20 subjects each depending of their sites of     stimulation, temporo-parietal or temporo-occipital. Each subject will perform three     experimental sessions (of 1h in average each) separated by at least one week and     corresponding to : (1) the right cortical stimulation, (2) the left stimulation and (3) the     vertex stimulation serving as the control session.      The TMS paradigm is used in routine in hospital and research field and had very few negative     consequences (mainly transitory and occasional headache).   "
115065|NCT01779739|"     This is a single center, double-blind, randomized controlled trial evaluating the change in     sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants     will be sexually active women who agree to randomization to having perineorrhaphy added to or     excluded from their surgical repair. We hypothesize that sexual function will improve more     significantly in women undergoing vaginal repair with perineorrhaphy.   "
115066|NCT01779726|"     Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease     is an important prognostic factor as an advanced stage reduces the opportunity for surgical     intervention and other curative treatment. In denmark, as in many other countries, a fast     track evaluation for lung cancer has been introduced in 2008.      When the general practitioners refer patients through the fast track, the majority of     patients make their first visit to the Department of Pulmonary Medicine. After this visit,     further investigation is initiated, which is often a CT scan of the chest and the upper     abdomen. We dont know Whether this is the most appropriate organisation.      The aim of this project is to evaluate the way lung cancer patients are examined through the     fast track and the impact of chest CT before an evaluation by a chest physician.      Investigators want to randomise all patients referred for the existing fast track to either     direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order     to test:      A) Fast track performance measured by number of CT scans and chest physician specialist time     per diagnosis, and whether there is a difference between the intervention and the control     group.   "
115078|NCT01779570|"     Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and     mortality worldwide. While viral replication can be suppressed by antiviral treatment,     excessive inflammatory responses, which are increasingly recognized to contribute to severe     influenza complications, remain unopposed. Macrolides have been used widely to treat     community-acquired pneumonia, and shown to exert anti-inflammatory effects in other     respiratory diseases, providing clinical benefits. In this randomized, open-label,     multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment     in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and     disease resolution will be studied. Such results may lead to the development of new     therapeutic approaches against severe influenza infection, and provide better insights into     disease pathogenesis.   "
115134|NCT01778842|"     The elderly represent a growing segment of the coronary population treated by dual     antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a     higher risk of both ischemic events and bleeding complications than younger patients, with a     subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated     the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit     is also present in the elderly remains a debated issue due to the lack of specific data in     this sub-population. The present study was realized to provide specific data on platelet     response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75     years old) whereas the superiority in PR response of the latter should allows the Prasugrel     therapy in elderly patients with the better clinical efficacy and therapeutical safety     already showed compared with Clopidogrel.   "
115067|NCT01779713|"     Rational: The main danger with intracranial aneurism is its rupture conjugated with     subarachnoid hemorrhage (SAH) occurrence. SAH is a severe pathology leading not only to     neurological but also extra cerebral disorders. The major cause of morbidity and mortality     when developing a SAH is the secondary development of a delayed cerebral ischemia consecutive     to a prolonged vasospasm of cerebral arteries. The understanding of the pathophysiological     mechanisms of SAH complication, such as vasospasm which is the more frequent, is essential.      Vasospasm is defined as a reversible shrinking of an artery lumen diameter in the     subarachnoid space, beginning generally between 4 and 12 days after the hemorrhage. Such a     vasospasm could have a huge clinical impact leading to delayed neurological ischemic     deficiency in 17 to 40 % of cases. Up to day, mechanisms involved in vasospasm occurrence are     not well described.      Disposing of well-established genetics and transcriptomics databases along with cerebral     ischemia and inflammation is essential to unravel the mechanisms leading to vasospasm     occurrence on SAH patients. It will enable researchers to better comprehend SAH pathology and     elaborate an efficient and individualized therapeutic strategy to SAH acute phase in order to     reduce the risk of vasospasm occurrence.      Aims: 1) Constitute DNA and RNA Biobank via blood proofing oh SAH patients 2) Constitute a     database grouping clinical and biological data 3) Look for genetic and transcriptomic early     markers via genomic approaches 4) Correlate these different markers with vasospasm occurrence     and clinical evolution of the patients      Study: Patients inclusion will be done following their admission (D1) in the  unité de     réanimation neurochirurgicale of Pitié-Salpètrière Hospital. After obtaining of the informed     consent, blood proofing will be realized daily during 12 days: one daily 2.5ml tube for the     transcriptomic study and a single 10ml EDTA tube for genetic analyses. Clinical and     biological follow-up will be performed as usual.      200 patients will be initially included during 2 to 3 years for the transcriptomic study of     which 1/3 will develop vasospastic complication. The transcriptomic study will thus be     performed by comparing patients developing or not developing this complication      Expected Results: Unravel vasospasm early genetic markers.   "
115068|NCT01779700|"     This will be a single site safety and proof of concept study conducted at the Indiana     University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective     disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo     for duration of 8 weeks.   "
115069|NCT01779687|"     Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the     increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma     low-density lipoprotein (LDL) cholesterol levels and is used for prevention of     artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the     preferred antiretroviral agents in HIV patients with dyslipidemia because it has a beneficial     lipid profile.      Theoretically, no clinically relevant drug interaction is expected between atorvastatin and     raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which     could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to     recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy     volunteers is proposed.   "
115070|NCT01779674|"     This study´s aim is to collect scientific data about patients with atrial inflammation by two     principles of sensors measuring congestive heart failure.   "
115071|NCT01779661|"     The objective of this research is to examine the effect of Infant Aquatics on the development     of and neurodevelopment of preterm and near-term infants, using the GM as prognostic     estimation of future development.      Preterm infants, a continuously growing population, are at high risk for neurodevelopment     impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly     due to developmental brain injury. Infant Aquatics have been found to benefit and promote     infant development. The support and sensory stimulation of the water may improve the     development the sensory, motor, as well as, autonomic system of preterm infants.      The study will compare intervention by Infant Aquatics to infant massage. The intervention in     both methods will start at 36 weeks gestational age for 3 months and will consist of sessions     with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18     months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive     behavior scales.   "
115072|NCT01779648|"     Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of     compression have been developed and used for prevention of deep vein thrombosis.      There are still some controversies about the physiologic properties and clinical impact of     numerous issues including the variety of the cuff length, inflation rate, compression     sequence, compression-relaxation cycle rate, and pressure generation characteristics.      This study is designed to compare clinical efficacies as well as venous hemodynamic     improvements between Simultaneous bilateral compression with fixed venous refill time versus     alternate compression with adjusted refill time   "
115073|NCT01779635|"     The investigators hypothesize that the use of heparin-grafted membrane versus conventional     membrane in critically-ill patients with bleeding-risk undergoing continuous renal     replacement therapy, will effectively prolong the circuit lifespan, without worsening of the     systemic APTT or underlying bleeding risk.   "
115074|NCT01779622|"     To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin     hormone secretion in healthy volunteers   "
115075|NCT01779609|"     The purpose of this study is to establish the effect of ET blockade on vascular adaptations     during an 8-week exercise program in subjects with T2DM. We hypothesize that combining ET -     blockade with exercise training leads to an acute increase of exercise induced blood flow     when compared with exercise alone. We expect that this will lead to an optimization of     vascular training effect in T2DM.   "
115076|NCT01779596|"     The purpose of this study is to establish the effect of ET blockade on the acute exercise     induced blood flow and endothelial function in subjects with T2DM. We hypothesize that     combining ET - blockade with exercise training leads to an acute increase of exercise induced     blood flow when compared with exercise alone. We expect that this will lead to an     optimization of vascular training effect in T2DM.   "
115077|NCT01779583|"     Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies     (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane.     It has been demonstrated that the content and function of exosomes depends on the originating     cell and the conditions under which they are produced. Tumor exosome production, transfer and     education of bone marrow cells supports tumor growth and metastasis.      In this prospective translational study, preclinical and clinical phases have been designed.     On the first step, the main goal is to characterize the molecular profile of gastric cancer     derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second     step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes     levels in plasma and kinetics in a prospectively recruited cohort of advanced gastric cancer     patients during first-line chemotherapy.   "
115079|NCT01779557|"     This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and     Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.   "
115080|NCT01779544|"     Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as     endurance, strength, stretching and information. Evidence concludes that it is not harmful to     return to activity after lumbar disc surgery, and restrictions to activities after these     operations are today more or less nonexistent. Some studies have shown that high intensity     programs might be more effective, but they are probably more expensive. In recent years     cognitive interventions have received more attention in rehabilitation programs after lumbar     disc surgery. The cognitive approach is focused on providing patient knowledge to reduce     uncertainty so that he or she can understand what is important after lumbar disc surgery so     that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to     resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation     program after lumbar disc surgery.      The study will be a randomized clinical trial. The study will compare two different     post-operative rehabilitation programs (general information or general information + exercise     therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy     group are supposed to continue with exercises 3 months.      In this study the following hypothesis will be studied:        1. Brief intervention, an educational model, alone after lumbar disc surgery do have the          same effect on pain in legs and low back as brief intervention, an educational model,          combined with exercise therapy.        2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program,          are being done by the patients.   "
115081|NCT01779531|"     Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer     patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol     neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete     response(pCR) are randomly divided into the group treated with XT protocol and the group with     Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the     disease free survival(DFS) and overall survival(OS) of two subgroup.   "
115082|NCT01779518|"     This is a single arm, open-label study which will be opened at specific clinical sites at the     request of an investigator for the treatment of individual subjects for whom there are no     other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD)     with RBV; pegylated interferon may be added at the discretion of the investigator.   "
115083|NCT01779505|"     This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) in     various doses and dosing regimens in healthy adults at one center in the US. Subjects will be     enrolled into 3 arms using a dose escalation scheme and randomized into one of two dosing     regimen cohorts. There will be 10 subjects per arm/cohort (total of 60 subjects to achieve 48     evaluable subjects enrolled), with study completion in 9-12 months.   "
115084|NCT01779492|"     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of     GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.   "
115085|NCT01779479|"     Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes     microtubules against cold-induced depolymerization as efficiently as docetaxel and was     selected for development based on a better antiproliferative activity on resistant cell lines     than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus prednisone in     docetaxel pre-treated hormone refractory metastatic prostate cancer patients leading to     registration of the compound. It showed a favorable toxicity profile with an interestingly     low rate of alopecia. In the Genevieve study it will be compared against weekly paclitaxel     which is currently most widely used treatment of breast cancer patients. A head-to-head     comparison in the neoadjuvant setting will allow a rapid and precise comparison of efficacy     and tolerability of cabacitaxel versus paclitaxel to decide in how far further development of     this taxoid in breast cancer is reasonable.   "
115086|NCT01779466|"     This trial will investigate the relationship of sleep, daytime performance and nocturia in     patients treated with Desmopressin or placebo. Male and Female patients will be administered     Desmopressin or Placebo every day for 3 months.   "
115087|NCT01779453|"     This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy     of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of     atorvastatin 10 mg.   "
115088|NCT01779440|"     Up to 77% of young people with severe mental illnesses smoke, a rate that is up to five times     higher than the rate of daily smoking in other young adults. Contrary to popular belief,     smoking tobacco does not provide any benefit for mental illness symptom control. People with     severe mental illnesses (SMI: schizophrenia and severe mood disorders) are dying, on average,     25 years earlier than those without SMI. Much of this early mortality is due to higher rates     of heart and lung diseases, cancers, strokes, and diabetes.      Cessation of smoking in these transition-age young adults can prevent cancer and increase     life expectancy to that of non-smokers. Combination treatments are effective in this group     and therefore key to improving outcomes, but few SMI smokers use them despite their interest     in quitting. Motivational interventions for cessation increase interest in quitting, but     public mental health clinicians do not deliver them, in part due to economic reasons. Thus     cost effective methods to deliver motivational interventions to engage young smokers with SMI     into treatment are needed.      To address this gap, we have developed an electronic decision support system (EDSS) for     smoking cessation that is specifically tailored for smokers with SMI, who tend to have     cognitive deficits and limited computer experience. Similar to EDSSs developed for other     health problems, this EDSS provides information and motivational exercises within an     easy-to-use, web-based computer program that can be used with minimal or no staff assistance.     Initial piloting of the EDSS in middle-aged SMI smokers showed excellent usability and     promising efficacy. Pilot-testing among young patients suggested that the EDSS increased     motivation to quit smoking and provided direction to adapt the format and content of the EDSS     for young SMI smokers.      The purpose of this proposal is to further develop the motivational decision support system     and to test its ability to motivate young smokers with SMI to quit smoking with cessation     treatment.   "
115089|NCT01779427|"     This is a research study to learn if a computer-based intervention that provides direct     attention and metacognitive strategy development can improve attention, memory, and executive     control in adolescents with moderate-to-severe TBI who are experiencing attention     difficulties post injury.   "
115100|NCT01779284|"     The primary objective of this crossover trial is to compare the 3-month, mean 24-hour     intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in     glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will     compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium     chloride given once in the evening, versus the latanoprost/timolol fixed combination given in     the evening. It is assumed that travoprost/timolol fixed combination will provide better     quality of 24-hour pressure control.   "
115101|NCT01779271|"     Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3     Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in     patients with Acute upper respiratory infection.   "
115090|NCT01779414|"     This study looks to implement a novel intervention (STAT-ED) for children who screen positive     to suicide ideation. The intervention looks to collect data from several different measures     and then randomize participants into one of two groups: a control group where the participant     will be set up with a mental health referral from a psychiatric social worker; or if     randomized into the STAT-ED intervention, the adolescent and parent will receive a brief     motivational interview, barrier reduction discussion, referral and limited case management by     the study social worker to enhance outpatient mental health follow up after discharge from     the ED.      The hypothesis of the study is patients who are randomized into the STAT-ED intervention     group will have a significantly higher rate of initiating mental health treatment and will     attend more mental health treatment sessions in the two months after the ED visit compared     with adolescents in the control group. Secondary aims of this study look to determine whether     the effectiveness of the STAT-ED intervention differs by age, gender, or ethnicity; and     evaluate predictors and mediators of mental health treatment engagement.   "
115091|NCT01779401|"     To identify the high-risk patients who might have in-stent thrombosis after PCI with     thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic     strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with     the standard antiplatelet therapy.   "
115092|NCT01779388|"     Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy will     be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique needing     validation. the primary aim of the study is to compare ENB to radiologically guided     bronchoscopy, considered the standard comparator.   "
115093|NCT01779375|"     The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with     prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose     lowering will lead to recovery of beta-cell function that will be sustained after withdrawal     of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following     treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin     glargine followed by metformin.      The primary clinical question RISE will address is: Are improvements in ß-cell function     following 12 months of active treatment maintained for 3 months following the withdrawal of     therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal     of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell     function, insulin sensitivity and glucose tolerance and the response to an intervention.   "
115094|NCT01779362|"     The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with     prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose     lowering will lead to recovery of beta-cell function that will be sustained after withdrawal     of treatment. Adult participants (ages 20-65) will be randomized to one of the following     treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive     insulin treatment with basal insulin glargine followed by open-label metformin, (4) the     glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.      The primary clinical question RISE will address is: Are improvements in ß-cell function     following 12 months of active treatment maintained for 3 months following the withdrawal of     therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal     of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell     function, insulin sensitivity and glucose tolerance and the response to an intervention.   "
115095|NCT01779349|"     Current gold standard of bladder outlet diagnosis is pressure flow study. This study is     invasive time consuming and requires expensive and complex set-up. In this study the     investigators plan to evaluate an alternative technology that presumably is able to diagnose     bladder outlet obstruction using a Dynamic Urine Vibration Holter based on a Urine Flow     Vibration Analysis technology. The acoustic vibration sensor is a small device that records     the vibration due to urine flow. The patient attaches the sensor to the penis using a     disposable sensor patch for the duration of approximately one minute during one urination.     The analysis is performed off-line and the results are compared to the results of a standard     pressure flow study and to the standard free flowmetry test. The innovative technology for     the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve     complex setup.   "
115096|NCT01779336|"     Clinical study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid     tumors. The primary objective is to determine the maximum tolerated dose and dose limiting     toxicity (ies) of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid     tumors.   "
115097|NCT01779323|"     The hypothesis is men with stress urinary incontinence, including those following radical     retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as     measured by magnetic resonance imaging (MRI) that improves significantly following sling     placement. The investigators theorize that the sling helps with primary hypermobility of this     pathophysiologic cause of stress urinary incontinence.   "
115098|NCT01779310|"     There are guidelines on the management of AD in China, the evidence adopted in the guidelines     are mostly from the trials conducted in other countries due to very limited Chinese data     available for local systematic review. Therefore, more local evidence on dementia care is     needed for the development of an evidence-based guideline appropriate for people living in     China. Meanwhile, the inadequate implementation of the current AD guideline, which results in     the low diagnostic rate and high diagnostic leakage, may bring about extra barriers for AD     patients to access dementia care service in different areas nationwide. However, there is no     data on the clinical pathway about how physicians follow the dementia guideline in the     routine practice.      Therefore, research is needed to learn clinical diagnostic process and treatment patterns of     physicians to people with AD in routine practice and help address the low accurate rate of AD     clinical diagnosis and low anti-dementia drug prescription in the real world and support     guideline development.   "
115099|NCT01779297|"     The purpose of this study is to determine whether introducing the new weaning indexes can     predict better than traditional ones?   "
115102|NCT01779258|"     The purpose of this study is to confirm that emollients play a major role in the maintenance     therapy after clearing of inflammatory lesions and can reduce occurrence of flares in     children with atopic dermatitis.   "
119619|NCT01720199|"     This is a field study aiming to evaluate a school-based prevention intervention, Diario della     Salute (DDS).   "
115107|NCT01779193|"     B streptococcal infection and the major cause of death before and after the baby is born. B     streptococcus infection the way of the newborn, usually infection from the mother in     childbirth, if the pregnant women during pregnancy early diagnosis B streptococcus infection,     it can be effective in preventing the risk of neonatal infection. Department of Health in     China has been since April 15, 2012, the Scholarship holder at all pregnant women in the     35-37 weeks of pregnancy comprehensive B streptococcus screening. Infection B Streptococcus     pregnant women in the labor process, the use of prophylactic antibiotics can be effective in     reducing neonatal B streptococcus infection, but the possibility of the fetus being infected     for the condition of premature birth or early rupture of membranes are still unable to fully     hedge. In this study, the 35 to 37 weeks gestation examination confirmed infected B     Streptococcus pregnant women, oral lactobacillus capsules B streptococcus infection treatment     efficacy and safety assessment of clinical research. To assess whether oral administration of     lactic acid bacteria will affect vaginitis incidence.   "
115108|NCT01779180|"     INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A supplementation     (NVAS) have been reported, and another four are underway to test whether NVAS should become     WHO policy. Three of the four African trials were conducted by the Bandim Health Project     (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among low-birth-weight     children. From 2004-2008, the children were randomly allocated to 25,000 IU vitamin A or     placebo at birth, and furthermore to BCG vaccination at birth or later as is local policy. In     2011, the investigators conducted a follow-up study. A remarkably strong harmful effect of     NVAS on atopy and wheezing was found (manuscript under review).      Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS     is associated with a higher risk of atopy and wheezing. The investigators therefore aim to     conduct a similar follow-up study of participants in the first NVAS trial conducted in     Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is     associated with an increased risk of atopy and wheezing and other allergic symptoms as well     as growth.      METHODS      Study population:      From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited newborns     when they came for BCG vaccination. Provided parental consent, they received an oral     supplement of 50,000 IU vitamin A or placebo.      Study design:      This study will be a follow-up study of the cohort of children randomised to NVAS     (intervention) or placebo (current policy) together with BCG vaccine at birth.      Other exposures:      The investigators will also investigate the effect of receiving an additional dose of measles     vaccine and the timing of DTP vaccine on the development of atopy.      Assessment of outcomes:      The investigators will visit all children at the last known address. Height, weight and mid     upper arm circumference will be measured. BCG scar will be examined and vaccination card     details recorded by the field assistant. Children will be excluded from skin prick testing     (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine     medication. SPT will be performed using aero-allergens, food allergens and positive histamine     and negative saline control. The mother or guardian will be interviewed by a local assistant.     Symptoms of eczema and asthma as well as food allergy will be assessed.      Statistical analysis:      Effect of randomisation group and other factors on outcomes will be analysed in multivariable     regression models. All analyses will be adjusted for skin prick tester. All analyses will be     conducted stratified by sex.   "
115109|NCT01779167|"     The purpose of this study is to evaluate the efficacy and safety of daily alternating     thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated     Waldenstrom macroglobulunemia (WM). Thalidomide and lenalidomide are drugs that modulate the     immune system and have been shown to bring about responses in subjects with WM. However,     their use has been limited due to side effects. The investigators hypothesize that     alternating doses of thalidomide and lenalidomide may alleviate the side effects while     preserving the effectiveness of the therapies.   "
115110|NCT01779154|"     The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that     does not involve medical interventions, but serves as a record of demographics,     characteristics of disease and treatment, utilization patterns, quality improvement measures     and clinical outcomes. The database is proposed so that epidemiologic research can be     performed and current and accurate data can be obtained regarding practice patterns, age and     gender distributions, efficacy of treatment, clinical outcomes and changes in quality of     life.   "
115111|NCT01779141|"     Purpose:      The aim of this observational study (registry) is to document the use of insulin pump therapy     (CSII) and sensor augmented pump therapy (SAP) before, during and after pregnancy in women     with Type 1 Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time     and Paradigm Veo pumps in Poland.      Objectives:      To assess the benefits of CSII and SAP on the maternal glycemic control; To assess the     prevalence of pregnancy complications (rates of preterm delivery, infant birth weight,     neonatal care admissions) from preconception phase, throughout pregnancy, during delivery and     after delivery during lactation phase (up to 6 weeks); To report and assess the potential     benefits of SAP or CSII on neonatal outcomes   "
115120|NCT01779024|"     Background:      - Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes     people feel hungry, and also is connected with the desire to drink alcohol. Researchers want     to test ghrelin to see if it can be used to control alcohol cravings and use. They will     compare doses of ghrelin with a placebo in people who drink heavily.      Objectives:      - To study the effects of ghrelin on alcohol craving and use.      Eligibility:        -  Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking          treatment for alcohol use.        -  Participants must on average have more than 20 drinks per week for men, and more than 15          drinks per week for women.      Design:        -  Participants will have a screening visit, four 2-night study visits, and a follow-up          visit.        -  Participants will be screened with a physical exam and medical history. They will          provide urine and breath samples for drug testing. They will also answer questions about          mood and physical symptoms, and about alcohol and other cravings.        -  At the study visits, participants will stay overnight at the National Institutes of          Health clinical center. They will spend the night at the center, have tests on the next          day, and go home on the following morning. At each visit, participants will receive a          ghrelin or placebo infusion, and will complete a series of tasks.        -  For the first and second study visits, participants will have tests of alcohol craving          and use. They will be able to receive alcohol infusions through a computer program that          tests response time and craving reactions. At the same time, they will have a ghrelin or          a placebo infusion. Blood alcohol levels, reaction time, and craving will be studied.        -  For the third and fourth study visits, participants will have a magnetic resonance          imaging (MRI) study. They will have an initial MRI to provide a picture of the brain.          They will then have a functional MRI during which they will respond to a computer test.          The test will allow them to win points for snack food or alcohol. This test will look at          the brain s response time and craving reactions.        -  There will be a follow-up visit 1 week after the fourth study visit. Some of the tests          from the screening visit will be repeated.   "
115121|NCT01779011|"     The prospective cohort study, SuTra2, assesses the functional and socio-economic status of     patients who were operated on for a severe limb injury resulting in amputation or limb     preservation 1 and 2 years after the 2010 Haiti earthquake.   "
115135|NCT01778829|"     The purpose of this study is to determine whether Nasal intermittent positive pressure     ventilation (NIPPV) non synchronized is better than continuous positive airway pressure     (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth     weight infants at the NEOCOSUR Network.   "
115136|NCT01778816|"     Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types:     open, percutaneous and conservative (non-operative) treatments.      Comparing force torque measurements, muscle volume and clinical scores.   "
115300|NCT01776658|"     The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in     patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability     are also evaluated.   "
115112|NCT01779128|"     This research study is an imaging pilot study. Imaging pilot studies explore the potential     benefit of one imaging approach compared to another clinically accepted approach. Such     studies serve to understand how feasible an approach may be and whether it is worth pursuing     in formal and larger clinical trials. Researchers of this study believe that simultaneous     Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging will offer     additional imaging information to improve cancer detection.      MRI and PET are two tests that allow us to take pictures of the body and look inside the     body without surgery. The MRI scanner uses a powerful magnet to make a picture of the body.     The PET scanner makes pictures by using special dyes that light up inside the body. PET     scans use radiation, similar to the radiation in a standard x-ray. We routinely use both     tests to diagnose various types of cancer. As of now, the combination of PET and computed     tomography (CT) has been considered a standard of care imaging approach for various cancers.      Until recently, MRI and PET tests were done separately. Now there is a new type of test     called MR-PET that combines both MRI and PET test results. This scanner uses both MRI and PET     tests at the same time. We would like to find out if the MR-PET scanner can produce better     and clearer images (pictures) of tumors and information about them inside of the body.      This new MR-PET scanner is approved by the US FDA. However, some of the computer programs     that tell the machine how to acquire and combine the test results are new and experimental.     Experimental means that some of the computer programs are not approved by the FDA. This means     that they can only be used in research studies. The MR-PET scanner has been previously used     in a few human participants.   "
115113|NCT01779115|"     A computerized registry of diabetes patients in a large health maintenance organization in     Israel. The registry is aimed to be used by health professionals to identify diabetes     patients and to follow the courses of their illnesses and risk factors.   "
115114|NCT01779102|"     A new, more specific skin test to detect tuberculosis has been developed by Statens Serum     Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a     positive test result will show as redness and/or induration at the injection site, while a     negative test will leave no reactions.      The aim of this study is to address if the size of induration and the sensitivity of C-Tb is     influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to     evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.   "
115115|NCT01779089|"     Diabetic kidney disease increases the risk of illness and death from heart disease in     patients with Type 2 diabetes. Some blood pressure medications called ACE inhibitors and ARBs     slow progression of kidney disease, but the dose that can be used is often limited by side     effects that are experienced by patients. The most limiting side effects of the current     treatments are lowering of the kidney function or blood pressure, and a rise in blood     potassium levels. A safe and inexpensive medication that doesn't lower kidney function or     blood pressure or raise serum potassium would be useful.      Minocycline is a tetracycline antibiotic with recently appreciated protective properties. In     a published journal article by Dr. Isermann, minocycline prevented the death of specialized     kidney cells in mice. The kidneys of these mice did not develop diabetic kidney disease when     seen under the microscope and the mice experienced only a little bit of protein loss in the     urine. In a different published paper, the authors showed that minocycline also decreased     kidney injury in a model of non-diabetic kidney disease. A related tetracycline antibiotic     was shown to lower urine protein in diabetic patients. These data support a rationale for     testing to see if minocycline is safe and helpful in patients with diabetic kidney disease.     In this study, all patients will stay on their usual medications for the treatment of     diabetic kidney disease. Patients will be given either minocycline (100 mg by mouth twice a     day for 24 weeks) or placebo (an inactive capsule taken twice a day for 24 weeks).     Minocycline or placebo will be assigned by a process called randomization, which is like a     coin toss. Neither the patient nor the study team will know if the patient is taking placebo     or minocycline until the end of the study. The study will assess minocycline safety and test     to see if minocycline is helpful or not helpful for the treatment of diabetic kidney disease.      This study was funded by the American Diabetes Association and is not supported by any     pharmaceutical company.   "
115116|NCT01779076|"     Using a protective ventilation strategy during general anesthesia from pre-oxygenation to     emergence and selecting patients without risk of a difficult airway or intubation, a lower     fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the     postoperative area of atelectasis without desaturations becoming more common.   "
115117|NCT01779063|"     Lymphedema is a chronic condition that causes physical and emotional challenges to breast     cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that     can impair function, promote infection, and cause discomfort and emotional distress. Daily     self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong.     Previous studies found that about half of breast cancer survivors with lymphedema do not     complete self-care as directed. Feelings of being helpless to manage the condition, a desire     to be normal, lack of noticeable results from self-care, and poor social/healthcare     professional support are barriers to performing self-care on a regular basis. There is a need     to develop and test interventions to promote effective self-care. Experts suggest the best     self-care interventions should include patient perspectives and be available a readily     accessible format. Technological advancements support use of innovative, creative approaches,     such as Web-based multimedia interventions. Web-based interventions can be used in rural and     urban settings. The investigators are proposing to develop a Web-based, multimedia     intervention and a take home manual to support self-care in breast cancer survivors with     lymphedema. The investigators plan to conduct focus groups with these survivors to determine     the content and delivery format(s) and to help us identify breast cancer survivors with     lymphedema for the video component. The investigators will then develop an intervention that     will include self-care demonstrations and other supportive information to help patients to     cope with the challenges of self-care. The focus groups will reconvene, review the     intervention, and give us feedback on modifying and refining the intervention. After     finalizing the intervention, The investigators will recruit more breast cancer survivors with     lymphedema and provide one half of them an education booklet and the other half the Web-based     intervention (or an alternative format such as DVD). Then, over 12 months, the investigators     will periodically assess and compare both groups on self-care behaviors, physical and     emotional concerns, and other issues such as money spent on lymphedema treatment. The group     that receives the education booklet will be given access to the Web-based intervention after     the 12 month follow-up is done, but the investigators will not ask them to complete any more     forms.      This project builds upon the investigators prior work that has provided information about     lymphedema self-care problems and the investigators previous experience in developing patient     education videos and manuals. By providing accessible, detailed self-care instructions and a     psychosocial component, this intervention has the potential to improve lymphedema self-care.     If successful, this intervention can be offered to the larger national and international     community of breast cancer survivors with lymphedema.   "
115118|NCT01779050|"     This phase II trial studies the efficacy of trastuzumab treatment in breast cancer patients     with stage II-III human epidermal growth factor receptor 2 (HER2)-negative tumors and     HER2-expressing bone marrow disseminated tumor cells. Administering targeted trastuzumab     therapy to these patients may result in the elimination of HER2 expressing disseminated tumor     cells and improved disease free survival.   "
115119|NCT01779037|"     IRF-PAI Functional Outcomes Data, including FIM instrument variables   "
115213|NCT01777802|"     Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and     systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been     identified, including low intratumor expression of antigens and elevated expression of     inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce     necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body     Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is     capable of delivering high, conformal radiation doses (>8 Gy) of tumor ablative radiation may     be an effective means of conditioning a tumor bed to a state favorable to the initiation of     robust antitumoral immune responses.   "
115122|NCT01778998|"     One of the most recent advances in cataract surgery is microincisional phacoemulsification     (MICS). Through small incisions of 2.0 mm and less the lens material is emulsified either     bimanually or with a thin single coaxial hand-piece. The possible advantages are lower     induced corneal astigmatism1, 2, possibly a lower incidence of infection due to higher     resistance of the wound to deformation3 and a lower risk of complications such as iris     prolapse during surgery in patients at risk such as with intraoperative floppy iris syndrome     (IFIS). Additional factors that have to be taken into account are the construction and the     position of the incision and the influence of the extraocular force on the wound morphology.4     Another effect that may influence the wound architecture is stromal hydration at the end of     surgery.5 Wound architecture has recently been assessed6-9 using optical coherence     tomography. Elkady et al.10 observed the wound architecture in MICS cases focusing on corneal     thickness and the incision angle. However, none of these studies observed the effect of the     wound architecture on post-operative astigmatism. Furthermore, all observations in the past     have been performed in the post-operative period only and information concerning the wound     architecture intra-operatively is missing. A recently launched CE-marked intra-operative OCT     allows observing the wound architecture intra-operatively.      One aim of the study is to assess the influence of the intra-operative wound architecture     using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to     deformation of the wound and the surgically induced astigmatism in MICS and small incision     cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged     incision with a pre-cut should be assessed along the same line   "
115123|NCT01778985|"     This is a study to determine how vaginal estrogen cream given for several weeks before pelvic     reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the     vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive     either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At     time of surgery, full thickness biopsies will be obtained from a standardized location at the     top of vagina. The investigators will measure the thickness of the vaginal muscularis,     elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is     affected by estrogen therapy. The results will provide important data to support a larger     clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term     success rates of pelvic reconstructive surgery for pelvic organ prolapse.   "
115124|NCT01778972|"     Fall-related injuries are a major health problem in the growing older population. Most older     people are not aware of that physical training can decrease the risk of falling. The aim of     tha study is to investigate the effect of the Otago home exercise programme with and without     motivational interviewing in community-dwelling people 75 years or older on frequence of     falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life,     mortality and health-related costs.   "
115125|NCT01778959|"     Cataract surgery is one of the most frequently performed surgeries worldwide and     complications are rare. However, there are factors that increase the risk of complications,     such as poor pupil dilation and intra-operative floppy iris syndrome (IFIS). Reasons for a     small pupil size are pseudoexfoliation syndrome (PXF) syndrome, uveitis or synechia and the     use of pilocarpin drops. IFIS is a syndrome usually caused by systemic alpha1-blockers     (foremost tamsulosin) used to treat benign prostatic hyperplasia.1,2 As described by Chang     and Campbell3 IFIS is characterized by billowing of a flaccid iris stroma, a propensity for     iris prolapse towards the phacoemulsification tip as well as towards the incisions and     progressive intra-operative pupil constriction.      Stopping tamsulosin pre-operatively did not show to effectively prevent IFIS.4,5 However, it     is of high importance to identify patients prior to surgery, who are treated with     alpha1-blockers, or patients with a small pupil size and poor pharmacological pupil dilation.     Some methods, such as intracameral injection of phenylephrine is only sufficient in a few     cases 6, and a disadvantage is the risk of a hypertensive episode.7 Another pharmacological     method is the use of atropine drops pre-operatively, but this method did not show to     sufficiently reduce IFIS.4      Different methods were shown to reduce intra-operative problems due to IFIS/small pupil size:      The use of highly cohesive ophthalmic viscosurgical devices (OVD), also called     viscoadaptives, such as sodium hyaluronate (e.g. AMO Healon5 or Croma Eyefill H.D.) help to     viscodilate the pupil and by resting on the iris during the entire phacoemulsification     procedure reduce the risk of iris prolapsing towards the incisions. This method is more     dependent on a central phacoemulsification technique and low fluidic parameters to allow the     OVD to stay on the iris during the entire procedure.8 In case of a small pupil, pupil     stretching with 2 instruments can be used additively.      Another option to stabilize the pupil size is the use of mechanical pupil expansion devices,     such as        1. Iris retractors - these devices are routinely used to dilate the pupil          intra-operatively. Typically, 4 or 5 iris retractors, also called iris hooks, are          inserted through 4-5 incisions. Usually, the IFIS pupil is very elastic and the risk of          overstretching is small.8        2. Pupil expansion rings, such as the Malyugin ring. This ring is placed on the pupil          margin with an injector through the main incision. It eliminates the need of additional          incisions and saves time.9      Rationale To compare different methods to manage IFIS and poor pupil dilation in cataract     surgery: a pupil expansion ring (Malyugin Ring), iris retractors (iris hooks) and a     viscoadaptive OVD.   "
115126|NCT01778946|"     This study will ascertain whether nicotine is safe and tolerable in DS patients, help with     dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning,     and establish evidence for biological and behavioral correlates of nicotinic stimulation     effects. The knowledge gained from the translational aspects of this project may also guide     the application of new nicotinic drugs in DS and generate, for the first time, data on the     importance of nicotinic receptor changes in the development of cognitive impairment in DS     adults.      Hypotheses:        -  Transdermal nicotine treatment will be well tolerated out to one month by non-smoking DS          patients without significant adverse effects.        -  Nicotine will enhance cognitive performance by one month compared to baseline and          post-treatment testing.        -  Nicotine will enhance functioning detectable by clinician and/or informant ratings          (pre-post).   "
115132|NCT01778868|"     Hormonal disruption is the inappropriate alteration of the hormonal system by chemical     substances that are present in our environment. Some chemical substances are capable of     replicating, enhancing or reducing the production, release, transport or action of natural     hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic'     endocrine disrupters such as pesticides and dioxins are considered responsible for     infertility, cancer and thyroid problems. Recently, a number of additional chemical     substances were stipulated to have endocrine disrupting capabilities. The industrial     production of these substances in large quantities has led to an accumulation in our     environment and thus possible negative consequences on human health.      The aim of this study is to investigate the rol of these chemical substances in the occurence     of overweight and obesity.   "
115133|NCT01778855|"     The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to     compare key imaging measurements for serial changes in recanalization and reperfusion between     hypothermia and normothermia treatment arms as intermediate outcomes of treatment effect.     Secondary exploratory analyses include imaging of the neurovascular impact of reperfusion     with hypothermia and tPA, including blood-brain barrier changes or permeability, hemorrhagic     transformation, and infarct growth.   "
115127|NCT01778933|"     According to the National Cancer Institute, an estimated 64,770 men and women will be     diagnosed with kidney cancer in 2012. Of this number, an estimated 13,570 will die of this     disease. Surgery remains one of the best options for patients presenting with operable Stage     II or III cancers, however the five year survival rate for these candidates remains at a     dismal 63.7% for Stage II and 11% for Stage III. The high rates of recurrence suggest that     surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory     manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin     through imaging during surgery it would be possible for the investigators to improve the     rates of recurrence free patients and thus overall survival.      Renal cell malignancies are the ideal disease to investigate intra-operative imaging. 70% of     kidney malignancies express folate receptor alpha (FRA). It is important to note that FRA is     expressed only in the proximal tubules of the kidneys, activated macrophages, and in the     choroidal plexus. Thus, the false positive detection rate is expected to be extremely low. A     group well known to us in the Netherlands has completed a pilot study utilizing a folate-FITC     conjugate in 12 patients with ovarian cancer. Another group of investigators in Mayo have     subsequently performed this study on 20 more patients without any serious adverse events     (personal communication). They report excellent sensitivity and specificity with this     technique with only grade 1 side effects (allergic reaction). All side effects reversed when     the injection was halted. Patients with a history of allergic reactions to insect bites     should not participate (fluorescein is derived from the firefly insect, folate is an     essential vitamin).   "
115128|NCT01778920|"     The goal of this study is to perform imaging of patient's tumors while the chest is open and     the tumor is being removed.      According to the World Health Organization, lung cancer is the most common cause of     cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide     annually as of 2004. Surgery remains the best option for patients presenting with operable     Stage I or II cancers, however the five year survival rate for these candidates remains at a     dismal 53% for Stage I and 32% for Stage II. The high rates of recurrence suggest that     surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory     manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin     through imaging during surgery it would be possible for us to improve the rates of recurrence     free patients and thus overall survival.      Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85%     of lung and pleural malignancies express folate receptor alpha (FRA). It is important to note     that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and     in the choroidal plexus. Thus, the false positive detection rate is expected to be extremely     low. A group well known to us in the Netherlands has completed a pilot study utilizing a     folate-fluorescein isothiocyanate (folate-FITC) conjugate in 12 patients with ovarian cancer.     Another group of investigators in Mayo have subsequently performed this study on 20 more     patients without any serious adverse events (personal communication). They report excellent     sensitivity and specificity with this technique with only grade 1 side effects (allergic     reaction). All side effects reversed when the injection was halted. Patients with a history     of allergic reactions to insect bites should not participate (fluorescein is derived from the     firefly insect, folate is an essential vitamin).   "
115129|NCT01778907|"     Depression is common among elderly with an estimated prevalence of 5%. Due to ageing the     national burden will double in the coming decade. Antidepressants as TCAs and SSRIs are     effective in reducing symptoms, especially in people with severe depression. To optimize     treatment efficacy and reduce side effects, the Pharmacogenetics Working Group of the Royal     Dutch Pharmacists Association developed guidelines for dose-adaptation, for instance for     antidepressants such as nortriptyline and venlafaxine based on their main relevant genotype     (CYP2D6) accompanied by Therapeutic Drug Monitoring. Such personalized drug dosing based on     pharmacogenetic information at the start of therapy can speed up the titration phase of     antidepressants to establish an adequate maintenance dose. However, pharmacogenetic screening     programs are expensive and evidence on effects and costs of such a program among elderly     antidepressant starters from randomized controlled studies is lacking. The investigators will     conduct a pragmatic randomized controlled trial to determine the effects and costs of     pharmacogenetic screening information to optimize drug dosing in depressed elderly patients     who start with nortriptyline or venlafaxine.      Objective: The primary objective is to determine the effects of pharmacogenetic screening for     CYP2D6 on the time to reach adequate blood levels as an accepted proxy for adequate     treatment. Secondary objectives include adverse drug reactions and cost-effectiveness      Study design: pragmatic randomized controlled intervention study   "
115130|NCT01778894|"     According to the most recent information released by the American Heart Association, heart     failure affects 5.8 million Americans and over 23 million people worldwide. In particular,     diastolic heart failure (DHF) has emerged in approximately half of those suffering from heart     disease and has become a major public health problem for many reasons, including the     complexity of the disease, lack of effective drugs/therapies, requirement of invasive tests     to diagnose and monitor DHF, and the absence of a suitable scientific model to study the     disease. Scientists and physicians alike still do not fully understand what happens to the     muscles in the heart (myocardium) patients who present with diastolic dysfunction or DHF.     Therefore, the medical field is in need of an accurate model that can evaluate how diastolic     dysfunction leads to heart failure and what happens at a cellular level as this disease     emerges and progresses.   "
115131|NCT01778881|"     Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth. It     may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the     prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Peripheral, central,     and psychosocial factors influence the disorder, which may predispose to pain in the     masticatory muscles and neck, headache, decreased pain thresholds in the masticatory and     cervical muscles, limitation mandibular opening, sleep disorders, stress, anxiety,     depression, and overall impairment of oral health. The aim of this study is to compare     physical therapy interventions with dental treatment in pain, mandibular opening, sleep     quality, anxiety, stress, depression, and oral health in individuals with bruxism.   "
115165|NCT01778439|"     This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects     with relapsed or refractory solid tumors. Study includes a dose escalation phase and     expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,     biomarkers, and efficacy.   "
115166|NCT01778426|"     Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over     2 years following SCS implant.      This study is requested by French Health Authorities for reimbursement renewal, to maintain     reimbursement for SCS in approved indication in France.   "
115137|NCT01778803|"     This is a Phase I/Ib, open-label, multicenter, dose-escalation trial of paclitaxel in     combination with defactinib (VS-6063), a focal adhesion kinase inhibitor, in patients with     advanced ovarian cancer. This clinical study is comprised of 2 parts: Phase I (Dose     Escalation) and Phase Ib (Expansion). The purpose of this study is to assess assess the     safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer     activity of defactinib (VS-6063) when administered in combination with paclitaxel.     Pharmacodynamic effects will also be examined in tumor biopsies.   "
115138|NCT01778790|"     The investigators will investigate in a sham controlled staggered onset design antidepressant     effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main     medial forebrain bundle (slMFB).   "
115139|NCT01778777|"     The primary safety objective is to demonstrate that severe device-related complication     (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at     a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to     dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical     repair.   "
115140|NCT01778764|"     The investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment     of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals.     The importance of this new knowledge will be to determine the treatment efficacy of CK RS     with 1-3 versus 4 or more brain metastases. The outcome of this trial would give data to     support either the continuation or modification of the CK RS treatment of patients with brain     metastases.   "
115141|NCT01778751|"     This study will determine whether Home Telehealth-based implementation of an evidence-based     intervention targeting Veterans with persistent poorly-controlled diabetes can improve     hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk,     high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care)     offers a feasible, sustainable, and generalizable approach to managing Veterans with     persistent poorly-controlled diabetes, which can be implemented using only existing Home     Telehealth services.   "
115142|NCT01778738|"     Glycaemia, insulin secretion and action in morbidly obes subjects with type 2 diabetes after     sleeve gastrectomy ond Roux-en-Y gastric bypass: A randomised single centre study.   "
115143|NCT01778725|"     Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of     the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus.     Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before     fulminant infection is developed. The aim of this study is to identify, as early as, possible     signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level     were associated with the occurrence and size of stroke and brain trauma in adults and     children. Moreover, S100B crosses the membrane and its level in women with preterm labor was     associated with brain injury of preterm infant.      The study question is whether the levels of S100B in women with early amniotic fluids     breakdown are associated with future brain injury of the infant, as assessed by head     ultrasound and neurological examination.   "
115144|NCT01778712|"     The aim of this study is to develop an intervention that will produce a sustained improvement     in physical activity and chronic stress as a means to slow the menopause-related accumulation     of visceral adipose tissue in mid-life women.   "
115145|NCT01778699|"     In a previous study the efficacy of Lb CD2 on interim covariates related to caries     development was tested. So, it was decided to plan a new study on schoolchildren from the     same area. The aim of the present research protocol was to evaluate the anticariogenic effect     of probiotics daily used, on the caries development in children. The null hypothesis was that     the probiotic Lb CD2 would not modify the caries risk of the children. Moreover, the study     will be carried out to investigate the plaque acidogenicity in situ following the regular     consumption of a probiotic product compared to a control group.      Objective: To determine the effect of a regularly consumed probiotic on the development of     new caries lesions.      Study design: Double blind, placebo-controlled, longitudinal study, monocentric, national, in     situ   "
115167|NCT01778413|"     The main objective is to determine the feasibility of maintaining virologic suppression on     standard plasma viral load by dose reduction of ATRIPLA ®.   "
115214|NCT01777789|"     The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in     middle-aged individuals with different levels of body fat. The ultimate goal of this research     is to develop an early diagnostic tool for Alzheimer's disease.   "
115215|NCT01777776|"     To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered     orally to patients with BRAF mutant melanoma.   "
115268|NCT01777074|"     The present study is conducted in order to assess the acceptability of Hepatitis B     vaccination in French general practitioners and peadiatricians before and after reimbursement     of the paediatric vaccine InfanrixHexa. Two data measurement time points are planned, first     before reimbursement and after reimbursement.   "
115146|NCT01778686|"     The serotonin 2A (5-HT2A) receptor is the most abundant excitatory serotonin (5-HT,     5-hydroxytryptamine) receptor in the human brain, and multiple positron emission tomography     (PET) studies have investigated the 5-HT2A receptors in the human brain using antagonist     radioligands. However, the currently available antagonist PET radioligands bind the total     pool of 5-HT2A receptor receptors whereas a 5-HT2A receptor agonist binds the high-affinity     subgroup of the receptors which are also G-protein coupled, and thus hypothesized to be the     functional relevant population of receptors. At the Center for Integrated Molecular Brain     Imaging (CIMBI), a novel agonist PET radioligands for brain imaging of 5-HT2A receptors was     recently validated in animals (Ettrup et al. 2011, EJNMMI). In the human brain, [11C]Cimbi-36     was validated as a selective 5-HT2A receptor agonist PET radioligand through a blocking study     with the 5-HT2A receptor antagonist pharmaceutical ketanserin. In this validation study, the     biodistribution and kinetic modelling of [11C]Cimbi-36 binding in the human brain was also     validated. With these studies, investigators will test the most promising of these,     [11C]Cimbi-36, in clinical trials, where it will provide a novel method for detecting     dysfunction in the 5-HT system. The specific aim of this clinical trial is:      - To examine the effect of acute alterations in 5-HT levels on cerebral [11C]Cimbi-36 binding     in healthy volunteers who will be PET-scanned at baseline and after pharmacological or     dietary interventions that either increase or decrease cerebral 5-HT levels.      It is hypothesized that this novel agonist radioligand will provide both a more physiological     relevant measure of the 5-HT2A receptors and also reflect levels of cerebral 5-HT in humans,     more specifically:      BP will decrease after pindolol and selective serotonin reuptake inhibitor (SSRI) treatment     and increase after acute tryptophan depletion (ATD). Placebo will leave binding potential     (BP) unchanged.   "
115301|NCT01776645|"     The purpose of this study is to determine whether compassion training will improve the     physical and psychological well-being of patients with chronic pain. The investigators also     want to determine whether any benefit of compassion training in the patients spreads to     significant others with whom the patient has a close relationship.   "
115147|NCT01778673|"     Background: Although fractures of the distal radius are the most common skeletal injury, the     utility of the available classification systems to predict fracture stability is limited. We     studied if cortical comminution and intra-articular involvement can assess instability in     fractures of the distal radius.      Methods: A prospective multicenter study was conducted. Distal radius fractures in 417     skeletally mature patients (428 fractures) were studied. Fractures were divided into     osteoporotic or non-osteoporotic according to age of the patients. Antero-posterior and     lateral plain radiographs determined if the fractures were minimally displaced or displaced.     The fracture patterns were evaluated depending on the presence and the site of cortical     comminution and intra-articular involvement according to a new classification system     (Buttazzoni classification). Minimally displaced fractures were treated with cast     immobilization. Displaced fractures underwent closed reduction with subsequent cast     immobilization. Radiographs were obtained after reduction, at 10-14 days and after 3 months.     Displacement was classified as primary instability, secondary instability or late     instability. Endpoints were union of the fracture or re-displacement. Results: Volarly     comminuted fractures (Buttazzoni 4) displaced in 96 %, intra-articular fractures (Buttazzoni     3) in 72%, dorsally comminuted fractures (Buttazzoni 2) in 73% and non-comminuted (Buttazzoni     1) in 16 % of the cases. One third of the initially minimally displaced fractures did not     maintain acceptable alignment. All initially displaced volarly comminuted fractures were     unstable. In both initially displaced and minimally displaced fractures, cortical comminution     and intra-articular involvement were predictive for primary, secondary and late instability.      Conclusions: Cortical comminution and intra-articular involvement seem to be valuable     instruments for assessing stability at initial presentation of distal radius fractures. Level     of Evidence: Level I, prospective multicenter study. Prognostic study.   "
115148|NCT01778660|"     This study compares standard versus mnemonic counseling for the treatment of fecal     incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women     randomised to mnemonic counseling will higher recall of treatments, satisfaction with the     physician visit and greater improvement in their quality of life when compared to women who     received standard counseling.   "
115149|NCT01778647|"     Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food     supplement in children with ADHD. No clear evidence for their role in this disorder is yet     available.      We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain     significant results regarding this question.   "
115150|NCT01778634|"     The purpose of this study is to determine whether intravenous azithromycin is effective in     eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks     gestation.   "
115151|NCT01778621|"     Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims     to compare assisted reproduction outcome between two groups of infertile PCOS patients     underwent IVF, one group received acupuncture and other group without acupuncture.   "
115152|NCT01778608|"     Sedation is often administered to relieve anxiety and discomfort during uncomfortable     procedures in elderly patients. Patient control of sedation offers many potential benefits     for patients and healthcare professionals, including improved safety and patient     satisfaction. The investigators overall goal is to develop a patient controlled intravenous     sedation system that is effective but very safe for the patient, and requires minimal     supervision by a doctor or nurse. To fulfill these criteria, a sedation system should     incorporate fail-safe safety mechanisms. A key safety-critical component is a method of     objectively assessing the degree of sedation of the patient, and of preventing him from     self-administering unsafe doses of the sedative drug. The investigators have designed a new     sedation system that uses a measure of the speed of response of the patient to a defined     non-noxious stimulus to determine whether or not it is safe to allow him to self-administer     further levels of sedation. Before being able to execute a volunteer study in order to     determine a rational selection of optimal threshold response time, a feasibility test on the     handset device is required.   "
115153|NCT01778595|"     Background:      - Early detection of colon cancer can improve the chances of successful treatment for most     people. This approach is especially important if blood is detected in the stool. However,     much better stool sample tests are needed to find this cancer early. To improve the tests,     researchers want to collect samples from people who are already being screened for colon     cancer. This study will collect information and samples from older adults in Shanghai, China.     These adults will be participating in screening tests for colon cancer.      Objectives:      - To collect samples and medical information for colon cancer screening from older adults in     Shanghai, China.      Eligibility:        -  Adults between 50 and 74 years of age who are being screened for colon cancer.        -  Participants will be recruited from two community health centers in Shanghai, China.      Design:        -  Participants will provide information on their medical history and factors related to          colon cancer. They will respond to questions on use of medications, diet choices (such          as eating red meat), bowel habits, and other factors.        -  Participants will collect samples for study. These samples will be collected within 3          days of the screening visit. Particpants will provide a urine sample and four stool          samples. They will also use cotton swabs to collect samples from just inside the anus.          The samples will be returned to the study doctors for research tests that may indicate          who has colon cancer.        -  Treatment will not be provided as part of this study.   "
115216|NCT01777763|"     The purpose of this study is to collect pharmacokinetic (PK) information related to how well     posaconazole tablet is distributed in the body and to determine the safety of this new     formulation. The study consists of a Phase 1B study that includes participants with     neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia     (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML     or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant     (HSCT).   "
120409|NCT01709825|"     The purpose of this study is to determine if daily consumption of a probiotic in the period     before, during and after academic exams will help maintain digestive and immune health and     quality of life of undergraduate students.   "
115159|NCT01778517|"     Background:      - Functional movement disorder (FMD) is a form of conversion disorder (CD). CD is a disorder     in which a person has neurological symptoms that do not have a neurological cause. These     symptoms can include pain, weakness, dizziness, and fatigue. Some thoughts on CD suggest that     it may come from feelings of anxiety that are converted into physical symptoms. Treatment for     FMD usually involves stress reduction, family help, and regular doctor s appointments.     Therapy interventions, however, have not been well studied. Researchers want to see if people     with FMD get better with psychotherapy. They will study two different types of psychotherapy:     group therapy and a self-help manual.      Objectives:      - To test two different types of therapy treatments for FMD.      Eligibility:      - Individuals at least 18 years of age who have been diagnosed with FMD by a neurologist.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have a psychological exam, and answer questions about their mood and symptoms.        -  Participants will be separated into three groups. One group will have group therapy.          Another will use a self-help workbook designed for people with FMD, and have individual          therapy sessions. A third group will just have standard care. During the study,          participants will continue to see their regular doctor.        -  Group therapy participants will meet once a week for 6 months at the National Institutes          of Health clinical center. There will be 8 to 10 people per group. Sessions will last 75          minutes. These sessions will work on methods for treating FMD.        -  Self-help workbook participants will have six individual therapy sessions over 3 to 4          months. They will use the workbooks to learn about and practice methods for treating          FMD.        -  All participants will be evaluated at 3, 6, and 12 months during the study.        -  At the end of the study, participants will have a final follow-up session with exams and          questions similar to the screening exam. They will return to the care of their regular          doctor.   "
115154|NCT01778582|"     Background:      - Very few people with cancer participate in clinical trials. Some are uncertain about the     treatment, or are afraid of being treated like a guinea pig. They may also feel that they     have inadequate information about the trial. One possible way of encouraging people to sign     up for clinical trials is to improve the informed consent process. Researchers want to     understand how people read and understand informed consent documents.      Objectives:      - To study perspective taking, and to study how people understand the information and     enrollment process for a clinical trial.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  This study will require one study visit.        -  Participants will watch one of four movie clips. They will be asked to respond to the          film by looking at it from the main character s perspective. They will then answer          questions about how the clips made them feel.        -  Participants will read a sample cancer clinical trial consent form on a computer. The          computer will record their eye movements while they read the text. They will then be          asked whether they remember the information in the consent form, and whether they would          participate in the trial.        -  No treatment will be provided as part of this study.   "
115155|NCT01778569|"     Background:      - Cardiometabolic diseases are medical disorders that can occur together and affect the     heart. They increase the risk of developing heart disease and diabetes. One disorder,     psoriasis, is an inflammation that mostly affects the skin but can affect the entire body.     Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited     on the wall of arteries. This causes arteries to harden and become less flexible. Many cells     that cause psoriasis also cause atherosclerosis. Researchers want to look at the relationship     between cardiometabolic diseases and psoriasis.      Objectives:      - To study the relationship between psoriasis and cardiometabolic diseases.      Eligibility:      - Individuals at least 18 years of age who have psoriasis.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have up to seven outpatient visits over the 4 years. The first visit          will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5,          will be scheduled yearly for the next 3 years. If participants have a psoriasis flare          with more severe symptoms, they may have an extra visit. Those who leave the study early          will have a final visit with the full series of tests.        -  At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and          medical history. They will provide blood and urine samples, as well as optional tissue          biopsies. They will also have heart function tests. Imaging studies, as well as optional          photographs of affected areas, will be performed. These tests will also be performed at          the final visit.        -  At visits 3 and 4, participants will have a physical exam and medical history. They will          also provide blood and urine samples, and have heart function tests.   "
115156|NCT01778556|"     Background:      - Lipodystrophy is a condition where people do not have enough fat in the body. People with     lipodystrophy can have problems such as diabetes or an enlarged liver. Researchers are     looking at how leptin, a hormone produced by fat cells, can help people with these problems.     Leptin helps control appetite and how the body stores food. Taking leptin can help people     with lipodystrophy eat less food, which may help treat diabetes and other problems. To better     understand how leptin works, researchers want to do an inpatient study on leptin treatment in     people with lipodystrophy.      Objectives:      - To study how leptin treatment affects lipodystrophy.      Eligibility:      - Individuals between 14 and 70 years of age who have lipodystrophy.      Design:        -  All participants will have a 19-day stay at the National Institutes of Health Clinical          Center. One group of participants will have tests for 5 days before starting to take          leptin. They will then take leptin for 2 weeks, and have more tests. The other group of          participants will have tests for 5 days while taking leptin. They will then take stop          taking leptin for 2 weeks, and have more tests, and then they will start taking leptin          again.        -  Participants will have regular blood and urine tests during the visit. Some of the blood          tests will look at insulin levels. Some will look at how the body metabolizes sugar and          fat. Other tests will check hormone levels, especially of reproductive hormones.        -  During the visit, participants will spend 3 separate days in a metabolic chamber, a          special room that measures how many calories the body uses. Urine samples will be          collected during these stays.        -  Participants will also have several body imaging studies, including magnetic resonance          imaging and a body composition scan.        -  Physical activity will be tested with an exercise bicycle and an electronic activity          monitor.        -  Participants will be asked questions about hunger and comfort levels throughout the          stay.   "
115157|NCT01778543|"     Background:      - Uveal coloboma is a condition where the eye does not form normally. It occurs early in the     fetus s development during pregnancy. It can lead to different kinds of eye problems,     including blindness. Several genes have been linked to coloboma, but the cause of most cases     is hard to find. Researchers want to study the genes of people who have coloboma and genes     from their close, unaffected relatives (such as parents and siblings).      Objectives:      - To study the genes associated with uveal coloboma.      Eligibility:      - Individuals at least 1 years of age who either have uveal coloboma or are an unaffected     relative (such as a parent or sibling).      Design:        -  Participants will have a physical exam and medical history. They will also have a full          eye exam.        -  Participants with uveal coloboma may have other exams, such as imaging studies and          hearing assessments.        -  All participants will also provide blood and cheek swab or saliva samples for genetic          testing.   "
115158|NCT01778530|"     Background:      - Glioblastoma is an aggressive type of brain cancer that often resists treatment. TRC105 is     an experimental drug that blocks the growth of new blood vessels. It is being studied for     possible use in treating different kinds of cancer. Researchers want to see if TRC105 can be     used to treat glioblastoma that has not responded to standard treatments.      Objectives:      - To test the safety and effectiveness of TRC105 in adults who have glioblastoma that has not     responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have glioblastoma that has not responded to     standard treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies and other tests will be used to study the          tumor before the start of treatment.        -  Participants will have 28-day (4-week) cycles of treatment.        -  Participants will have TRC105 intravenously once a week. The first infusion will take          about 4 hours. The length of time needed for the infusion may be slowly reduced if it is          well tolerated.        -  At the end of the first cycle (the first 4 weeks), the imaging studies will be repeated          before continuing TRC105.        -  Participants will take TRC105 for as long as the tumor does not grow and the side          effects are not too severe. They will have imaging studies at the end of every cycle to          evaluate the tumor.   "
115168|NCT01778400|"     Ultrasound-guided ethanol ablation is an effective treatment modality for patients with     cystic thyroid nodules (cystic portion > 90%); however it is less effective in predominantly     cystic thyroid nodules (90% > cystic portions > 50%). The volume reduction after EA has been     reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26%     (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to     patients with incompletely resolved clinical problems after EA and the mean volume reduction     ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both     predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated     the patients who were unsatisfactory after EA, to the best of our knowledge, no study to date     has compared these two ablation techniques. Therefore investigators performed a prospective     randomized study to compare single-session RF ablation and EA for treating predominantly     cystic thyroid nodules.   "
115160|NCT01778504|"     Background:      - Many psychiatric, behavioral, and developmental disorders are genetic. This means that they     tend to run in families. Some begin in childhood, while others do not appear until adulthood.     Researchers want to look at people of all ages who have these disorders that started in     childhood. They will also look at relatives of people with these disorders. This information     will allow doctors to learn more about childhood behavioral problems and how they are     inherited. It may also help doctors treat those disorders.      Objectives:      - To study the onset and treatment of childhood behavioral, psychiatric, and developmental     disorders.      Eligibility:        -  Individuals of any age who have a psychiatric, autism spectrum, or developmental          disorder, or other behavioral problems.        -  Family members of individuals with the above disorders. This group may include parents,          grandparents, siblings, aunts/uncles, cousins, and children.      Design:        -  Participants will be screened with a medical history and physical exam. They will have a          psychiatric history with tests of thinking, judgment, and behavior. Blood and urine          samples will be collected. Brain imaging scans will be performed to look at brain          function. They may have a spinal tap to collect cerebrospinal fluid.        -  Relatives will have a medical history and physical exam. They will also have a          psychiatric history with tests of thinking, judgment, and behavior. Blood and urine          samples will be collected. Brain imaging scans will be performed to look at brain          function.        -  A relative s exams may reveal a behavioral or other disorder. If so, he or she may          re-enroll on the study as a person with the disorder.   "
115161|NCT01778491|"     Background:      - Age-related macular degeneration (AMD) is a disease that blurs the sharp vision needed for     activities such as reading, sewing, and driving. It affects the macula, the center of the     retina at the back of the eye, which allows a person to see fine detail. Researchers want to     collect medical histories, eye exam data, and genetic information that may be associated with     AMD. They want to compare this information with information collected from people without     AMD.      Objectives:      - To collect medical information and gene samples for researchers studying AMD.      Eligibility:        -  Individuals between and 60 and 90 years of age who have AMD in at least one eye.        -  Individuals between and 60 and 90 years of age who have no AMD in either eye.      Design:        -  This study will involve one study visit. This study visit will last 6 to 8 hours.        -  Participants will have the following tests and exams as part of their study visit:        -  Full physical exam and medical history        -  Full eye examination        -  Laser scan of the eye        -  Retina function test        -  Vision sensitivity test        -  Optional blood sample (for genetic study)        -  No treatment will be provided as part of this study.   "
115162|NCT01778478|"     Background:      - An interview called the Schedule for Affective Disorders and Schizophrenia for School Age     Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems     among children and younger teens. Both the child and a parent are asked questions about the     child s behaviors and symptoms that might indicate such problems. Researchers want to see if     the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two     groups of young adults, including healthy volunteers and people with cancer, and their     parents will participate in this study.      Objectives:        -  To see if the K-SADS-PL interview used for children and teens can also be used for young          adults.        -  To see whether information provided by parents will affect the rate of mental health          problems found.      Eligibility:        -  Individuals aged 18-25 years who have cancer and are participating in research studies          at the National Institutes of Health.        -  Healthy volunteers aged 18-25 years.        -  A parent of a young adult who is participating in this study.      Design:        -  This study requires one study visit that includes an interview and self-report          questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will          also be required.        -  Young adult participants will be given the K-SADS-PL interview and four questionnaires          that ask about mood, anxiety, distress, parental contact, and development during          childhood. The K-SADS-PL interview will be video recorded or audio recorded.        -  Parents will also be given the K-SADS-PL interview. This interview can be done in person          or by phone, and will also be recorded.        -  No treatment will be provided as part of this study.   "
115163|NCT01778465|"     Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and     nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus     surgeries and/or aspirin desensitization. However, these treatments have potential adverse     effects.      A theory has been postulated that decreasing the level of dietary salicylates may help in     long-term control of disease. A current trial is in the works to evaluate the clinical     outcomes of decreased salicylate, but measurements of biochemical markers of disease has not     yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease     in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are     typically elevated in this disease.   "
115164|NCT01778452|"     The aim of this study is to analyse genomics profile expression in endometrium under     different endometrial priming for recipients.   "
120437|NCT01709461|"     the purpose of the study is to extend the use of Rasagelin Mesylate 1mg per day by subjects     who participated in the Adagio TVP 1012/501 according to form 4a for additional three years.   "
115170|NCT01778374|"     In the M-BRiHT study we aim to implement a programme of opportunistic HIV screening in the     Emergency Department, Mater Misericordiae University Hospital. We hypothesize that such a     programme will be acceptable in an Irish setting. We also wish to study the factors that     influence test completion or acceptance. We will utilise informative interactive video media     via a touch-screen tablet device to provide pre-test counselling and then offer rapid     minimally invasive testing with a cotton-bud type swab of the buccal mucosa. In doing so we     will to determine absolute numbers of those attending the ED who consent to watching the     interactive information video about rapid HIV test screening. We will describe the absolute     number and proportion of those who watch the interactive video who subsequently proceed to     have the rapid HIV test. The primary aim is to determine the cultural, gender and ethnic     factors which influence the completion of such rapid HIV testing with the future objective of     maximising test completion in this crucial public health area.   "
116151|NCT01765790|"     The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and     pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors (Arm 1) and in     subjects with metastatic adenocarcinoma of the colon or rectum (Arm 2).   "
115172|NCT01778348|"     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong     insulin therapy. Children and adolescents with T1D need regular insulin injections or the     continuous insulin delivery using an insulin pump in order to keep blood glucose levels     normal. We know that keeping blood sugars in the normal range will help prevent longterm     diabetes-related complications involving the eyes, kidneys and heart. However, achieving     treatment goals can be very difficult as the tighter we try to control blood glucose levels,     the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia).     This is a particular problem at night and one solution is to develop a system whereby the     amount of insulin injected is controlled by a computer and is very closely matched to the     blood sugar levels on a continuous basis. This can be achieved by what is known as a     closed-loop system where a small glucose sensor placed under the skin communicates with a     computer containing an algorithm that drives an insulin pump. We have been testing such a     system in Cambridge over the last five years in children and have found that this system is     effective at maintaining tight glucose control and preventing nocturnal hypoglycaemia. More     recently the system has been tested in real life conditions in the home setting for three     weeks during a pilot single-centre study.      The next step is to extend the evaluation of closed-loop over a prolonged period of three     months. In the present study we are planning to study 24 young people aged 6-18 years on     insulin pump therapy. During three months glucose will be controlled by the computer and     during the other three months the subjects will make their own adjustments to the insulin     therapy using real-time continuous glucose monitoring.      We aim to determine the effect of the computer algorithm in keeping glucose levels between     3.9 and 8 mmol/L (normal levels). Safety evaluation comprises assessment of the frequency of     severe hypoglycaemic episodes. Participants' response to the use of the system in terms of     lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We     will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).   "
115173|NCT01778335|"     The purpose of the study is to understand whether a new treatment of stroke - endovascular     clot removal - can be added to the current standard of care to improve patient outcomes.      All patients will receive the best standard stroke treatment. This includes treating patients     with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work     in some patients and others are not eligible to receive t-PA because they present too late     for treatment (they woke up with their stroke symptoms or their stroke was not witnessed).      During endovascular revascularization the blockage in the artery is removed with the use of     devices called stentreivers and or by giving clot dissolving drug at the site of the blockage     in the artery to restore blood flow. Stentrievers are devices that have been designed by     different companies to remove blood clots from arteries.      Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will     participate in this study.   "
115174|NCT01778322|"     The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm     Embolization System used to embolize intracranial aneurysms   "
115175|NCT01778309|"     In this investigation the investigators utilized NAC administration to foster GSH     availability during an 8-day period following eccentric exercise-induced muscle damage in     order to test our hypotheses: i) antioxidant supplementation does not disturb performance and     adaptations induced by exercise-induced muscle injury and ii) redox status perturbations in     skeletal muscle are pivotal for the regulation of muscle' inflammatory response and repair.   "
115176|NCT01778296|"     The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because     of its similar quality to the original. The dorsal digital island flap can be used for     repairing the defect of adjacent finger, but the limited length of the pedicle precludes its     use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal     branch of the digital nerve can be used as an alternative to resolve this problem.   "
115177|NCT01778283|"     The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac     index and cardiac output measured by saline dilution techniques compares with Acetate-based     solution in online-hemodiafiltration   "
115178|NCT01778270|"     This study investigates if data about monitoring the drainage of pleural effusion can be     collected by non invasive sensors (feasibility).   "
115179|NCT01778257|"     Obesity is a major health issue worldwide; there is a constant raise in obesity related death     each year.   "
115180|NCT01778244|"     Almost all antipsychotics can induce dyslipidemia, but no treatment has been established.     Metformin can improve lipid levels in obese patients. The investigators conducted a     randomized, placebo-controlled study to test the efficacy of metformin for     antipsychotic-induced dyslipidemia.   "
115181|NCT01778231|"     This study aims to investigate genetic and environmental determinants of macular pigment (MP)     and assess the effects of lutein and zeaxanthin-rich supplements on macular pigment levels.   "
115182|NCT01778218|"     This study will assess the safety and tolerability of the investigational radiolabeled     imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG).     Additionally, the study will determine the specific times to best image the heart using a     SPECT camera with the investigational imaging agent and compare the images to those taken     while undergoing the standard rest and exercise/regadenoson testing previously performed to     detect the presence and severity of Coronary Artery Disease (CAD).   "
115217|NCT01777750|"     The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic     myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling     to temperatures below 35°C before revascularisation can additionally reduce infarct size and     therefore improves outcome in these patients.      The purpose of the study is to determine if a combined cooling strategy started in the     out-of-hospital arena is able to reduce infarct size in acute myocardial infarction.   "
115192|NCT01778088|"     The purpose of this study is to determine the recommended dosing of I-131-CLR1404, a     radiolabeled therapy compound, for treating subjects with glioma.      Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the     study will be conducted in three phases, dosimetric, therapy, and follow-up. In the     dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole     body imaging on on the day of infusion and on post-infusion days 2, 3, and 7 for assessment     of biodistribution and tumor uptake of I-131-CLR1404. If normal and expected biodistribution     are demonstrated, the subject will begin the therapy phase. In the therapy phase, the     subjects will receive a dose based on body surface area and may receive additional doses if     they meet dosing criteria. After the last treatment dose, subjects will enter the follow-up     phase and will be followed monthly.      All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to     injection of the dosimetric dose, and continuing for 14 days after the administration of the     therapy dose.   "
115193|NCT01778075|"     The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET     extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current     marketed ULTRACET ER tablet, in healthy participants under fasted condition.   "
115183|NCT01778205|"     The recent fall in birth and death rates has led to demographic changes such as low fertility     and high life expectancy . The WHO reports the median age of the European population to be     the highest in the world and predicts that the proportion of over-60s in will increase from     14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being     in the ageing population. Longevity with a good quality of life is a consequence of the     combination of an individual's genes, nutrition, environment, lifestyle and medical     interventions. There is increasing evidence that research into healthy ageing needs to start     with early life data to capture all traits and exposures experienced by an individual     throughout life. Epigenetic imprinting occurs both in utero and during early postnatal     development. Maternal environmental exposures, including nutritional status, may have a     permanent effect on the developing foetus by influencing epigenetic profiles and leading to     life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due     to poor maternal nutrition during pregnancy increases risk in the offspring of developing     mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To     understand the basic mechanisms and interactions through which the ageing phenotype develops,     systems involved in key processes of early development must be considered as well as those     crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal     study. In the first phase, blood is collected from pregnant women at <12, 15, 24-27 and 34     gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and     supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at     <12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of     Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also     recorded. The first phase investigates the association between gene-environment (nutrient and     lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of     the study follows up the children at 7.5 years of age. Growth, exercise and nutritional     habits as well as environment and cognitive development are assessed. The aims are to     investigate the association between gene-environment interactions associated with healthy     development from early pregnancy until 7.5 years of age.   "
115184|NCT01778192|"     Adequate bowel cleansing is important for a completeness of colonoscopy and detection of     colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and     obscured mucosal visualization resulting in missed lesions.      Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene     glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium     picosulphate with magnesium citrate (SPMC).      There are rare reports that compare directly conventional polyethylene glycol (PEG) solution     and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.      The aim of this study is to compare the efficacy, safety, and tolerability of different     regimens of SPMC and PEG solution.   "
115185|NCT01778179|"     To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy     when used in the pre- and post-procedure phases for the treatment of solar lentigines on the     back of the hands and in the prevention of post-inflammatory hyperpigmentation after     cryotherapy.   "
115186|NCT01778166|"     Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed     immune function, which might be worsened by major elective surgery.Enteral nutrition has been     emphasized for patients with GI malignancy during the perioperative period to accelerate     bowel function recovery, and improve nitrogen balance and immune response while reducing     postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote     the postoperative recovery of GI function and has been considered to have other advantages     such as the reduction of medical cost and maintenance of intestinal barrier function.     Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been     put forward to modulate the immune response and improve the immune function in patients with     cancer, which may have an better effect on the immune system than standard enteral nutrition.     However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy     surgery are scarce.      The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN)     is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune     function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after     laparoscopic GI surgery.   "
115187|NCT01778153|"     The purpose of this study is to compare the Equinox Personal Coaching exercise training     method to self-directed exercise training in helping subjects become more fit. Men between 30     and 44 years of age who exercise on a regular basis and are interested in receiving Equinox     personal training will be invited to participate. The investigators will enroll 36 subjects     at University of California, Los Angeles (UCLA), the only site. The hypothesis of this study     is that subjects randomized to the Personal Coaching Method will result in significantly     greater lean mass accrual than those randomized to self-directed training over the 12 weeks     of the study.      Subjects will have 2 Baseline visits over 1 week, then be randomized to receive either     Coached training or self-training, which they will do for 12 weeks, then complete two End of     Study visits over the final week. Visits 1 and 3 include questionnaires, skinfold fat/lean     body mass measurements, and strength and aerobic performance tests, and will take place at     Equinox. Visits 2 and 4 include a DEXA scan and ECG, which will take place at UCLA.   "
115188|NCT01778140|"     The investigators hypothesize that a Clinical Decision Support System (CDSS) designed with     Patient-Specific reminders yields superior performance than that with     Non-patient-specific reminders in preventing contrast-induced nephropathy.   "
115189|NCT01778127|"     Five year survival following a diagnosis of childhood cancer has reached 83%, making long     term health outcomes among survivors an important concern. The growing population of     survivors is at an increased risk of physical inactivity and associated adverse health     outcomes. Regular physical activity is associated with better cardiovascular and     musculoskeletal health. Despite the known benefits of physical activity, nearly half of all     childhood cancer survivors do not meet recommended guidelines for physical activity.      Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a     rewards-based physical activity intervention delivered via an interactive website among young     adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical     activity levels and improve cardiovascular and musculoskeletal health. The investigators also     want to learn if this rewards-based intervention is effective. To achieve this goal the     investigators have designed a three-arm prospective, randomized study with two reward-based     intervention groups and a control group.   "
115190|NCT01778114|"     The purpose of this study was to determine whether vitamin D2 and vitamin D3 in orange juice     are effective at raising vitamin D levels in the blood and if vitamin D2 and vitamin D3 in     orange juice raised blood levels of 25(OH)D as well as vitamin D3 and vitamin D2 supplements.   "
115191|NCT01778101|"     This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants     with gastroesophageal reflux documented by 24hr pH impedance monitoring   "
125435|NCT01643239|"     The purpose of this study will employ clinical assessment tools to examine the effects of     modified constraint-induced therapy (mCIT) on the more affected upper extremity of children     with cerebral palsy.   "
115195|NCT01778049|"     The objective of the study is to investigate the efficacy, safety and tolerability of     linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM     patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary     objective of efficacy evaluation is planned after 24 weeks of treatment. The study is     designed to show superiority of the combination of empagliflozin and linagliptin over     empagliflozin alone.   "
115196|NCT01778036|"     The primary purpose of this study is to investigate if there is altered motor control of head     and neck in chronic neck pain patients compared with healthy persons. In addition,     associations between neck pain, motor control, disability and function, and clinical symptoms     will be studied in patients following physiotherapy treatment in primary health care.   "
115197|NCT01778023|"     This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety     of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.   "
115198|NCT01778010|"     Treatment for cocaine dependence is characterized by high rates of relapse, yet the factors     influencing the likelihood of relapse are poorly understood. Exposure to cocaine, stress and     cocaine-related cues increase cocaine craving, and genetic polymorphisms in the dopamine D4     receptor subtype (DRD4) influence the effects of cues and drug exposure on ratings of     craving. However, craving does not robustly predict drug use or relapse. There are currently     no data characterizing the interaction between DRD4 polymorphisms, cues and cocaine exposure     on actual cocaine taking, i.e., cocaine self-administration. Incorporating measures of     relapse into our established laboratory model is an important objective for medications     development because models of cocaine self-administration have predictive validity in     screening medications for cocaine dependence. Aim 1: Refine our cocaine self-administration     procedures to include measures of relapse. The model is guided by hypotheses supported by     pilot data: The likelihood of relapse and the quantity of cocaine self-administered following     relapse will vary as a function of (1) the cost of cocaine, (2) the presence of contextual     cues associated with cocaine-taking, and (3) noncontingent cocaine administration (i.e.,     'priming'). Aim 2: Determine the influence of DRD4 polymorphisms on cue- and cocaine-induced     relapse. Data with alcohol have demonstrated that individuals heterozygous or homozygous for     7 or more allele repeats (DRD4L) show increased cue- and alcohol-induced craving and greater     relapse clinically than those with fewer than 7 allele repeats (DRD4 S). We hypothesize that     cocaine-dependent DRD4 L volunteers will show greater cue- and prime-induced relapse compared     to the DRD4 S group. Aim 3: Test the effects of modafinil on measures of cocaine relapse as a     function of DRD4 polymorphisms. We hypothesize that modafinil will: (1) decrease the effect     of both cues and a cocaine prime on the likelihood of relapse compared to placebo, (2)     decrease the amount of cocaine self-administered if cocaine use is initiated, and (3) be more     effective decreasing cue-and cocaine-induced relapse in the DRD4 L group than the DRD4 S     group.      This study will provide valuable information about the interaction between genetic     variability, modafinil and environmental factors believed to increase cocaine relapse.   "
115199|NCT01777997|"     This study is being done with people who are infected with HIV, but do not show any signs of     having HIV. They are also feeling well without taking HIV medication and have low or     undetectable levels of the virus in the blood. The purpose of this study is to see if taking     HIV medication (antiretroviral therapy [ART]) will reduce immune activation (a signal that     the body is fighting an infection) in people who have HIV, but do not show symptoms. Also     this study will help determine how safe the drug is and how well people react to the drug.      For this study, the following antiretroviral therapy (ART) will be provided in the form of a     single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir     disoproxil fumarate (FTC/RPV/TDF). These drugs are combined as one tablet which is approved     by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV     medication provided is one of the recommended treatments for HIV, including people with low     viral loads (how much HIV you have in your body) who are taking HIV drugs for the first time.     The risks seen with this HIV medication are the same that one would encounter when taking     these drugs outside of the study.   "
115200|NCT01777984|"     The purpose of this study is to determine the relationship among the body fat distribution,     especially the visceral fat, in patients with age-related macular degeneration in comparison     to patients with a normal fundus.   "
115209|NCT01777854|"     The study aims to determine if treating pediatric patients (age 7-17) for four weeks with     omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is     that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance     into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid     irritation of the surgical wound (tonsil fossas).      The study will be a prospective double blind randomized study. Participants will be invited     to participate in the study by giving the study information at the preoperative assessment,     when the decision is made to have a tonsillectomy performed. If the patient agrees to     participate in the study, a written consent and child assent will be obtained and the patient     will be randomly assigned to a treatment versus control group based on the randomly assigned     participant number.      The treatment group will then be given a four week course of omeprazole to be taken for the     four weeks prior to tonsillectomy. The patient will be given a post tonsillectomy assessment     form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral     intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the     postoperative visit or mailed in.      The pain level and oral intake between the two groups to will be compared to determine if     antireflux control helps decrease the postoperative pain after tonsillectomy.   "
115210|NCT01777841|"     The MC Health Connection Discovery trial is designed to determine if a new health information     system that delviers interactive care plans (delivered by mobile) to patients can impact     post-surgical recovery.   "
115218|NCT01777737|"     First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which     causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole.      Cotrimoxazole may improve the clinical course of the disease through eradication of     Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of     alveolar macrophages and producing alterations in the surfactant system which favours the     persistent activation of the inflammatory response and the development of pulmonary fibrosis.   "
115219|NCT01777724|"     The study will use a randomised controlled trial design to evaluate the effects of a combined     intervention of Triple P-Positive Parenting Program Discussion Groups and Stress Control in     comparison to a waitlist condition. The combined intervention will be evaluated with parents     in Glasgow, United Kingdom, with a 3-8 year old child.   "
115220|NCT01777711|"     This study explores among couples in which both members are obese how the use of mental     contrasting along with implementation intentions influence intentions and behavior related to     weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons     (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about     weight loss, confidence in being able to eat healthy and diet).   "
131032|NCT01569906|"     To assess prospectively, the response of moderate to severe atopic eczema to a standard     course of narrowband ultraviolet B phototherapy by using validated objective and subjective     scoring systems.   "
115201|NCT01777971|"     Ascites is the accumulation of fluid within the peritoneal cavity of the abdomen. It is a     frequent complication of cirrhosis that is associated with significant morbidity and poor     quality of life. Large-volume ascites has been associated with impaired pulmonary function.     In a previous study, the presence and severity of ascites were determined to be significant     determinants of fatigue.      In this study, we will determine whether large-volume ascites contributes to fatigue by     assessing the response to drainage of ascites by means of a procedure called large-volume     paracentesis. We hypothesize that treatment of ascites with a single large-volume     paracentesis leads to decreased fatigue and improved quality of life and that this     improvement is associated with improved sleep pattern.      20 patients with cirrhosis with refractory ascites requiring regular drainage of ascites     fluid by large-volume paracenteses will be recruited for the study. All patients will undergo     a complete clinical and physical examination for liver function, including blood tests.     Hepatic encephalopathy, a change in mental status associated with liver dysfunction, will be     assessed by obtaining historical data and by means of simple bedside neuropsychological     examinations.      Study visits will take place on two consecutive days, with each visit lasting approximately     2-3 hours. Immediately prior to a large-volume paracentesis, patients will complete     standardized questionnaires for fatigue severity, quality of life, quality of sleep, and a     physical assessment of fatigue by means of a 6-minute walk test. Repeat evaluations will be     performed 1 day after the procedure. Statistical analysis will then be performed to determine     the effect of the paracentesis on the various clinical assessments.   "
115202|NCT01777958|"     This observational study will evaluate the efficacy, safety and patient reported quality of     life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin     (trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally     recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy. Additionally,     information on selection criteria of breast cancer patients treated first-line with Perjeta,     Herceptin and chemotherapy and their treatment duration will be collected and analyzed. Data     will be collected from eligible patients for up to 20 months of treatment and 24 months of     follow-up.   "
115203|NCT01777945|"     This multicenter observational study will evaluate the efficacy and safety of Xeloda     (capecitabine) in combination with docetaxel in first-line therapy in participants with     HER2-negative metastatic breast cancer. Participants will be followed for approximately 6     months of treatment.   "
115204|NCT01777932|"     This multicenter, single-arm observational study will evaluate the clinical benefits of     Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with     metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin     treatment within 6 months prior to study start will also be eligible. Data will be collected     from patients for up to 5 years.   "
115205|NCT01777919|"     Glioblastoma multiform (GBM) is the most common malignant primary brain tumor in adults.     Despite maximal treatment tumor relapse occurs regularly accompanied by unfavourable     prognosis. Among other reasons, it is believed that this could be in part due to the     existence of the so-called tumor stem cells (TSCs), a cellular subfraction within GBM which     escape therapy by being highly resistant to irradiation and chemotherapy and thus     constituting the source of tumor recurrence.      GBM, like many other cancers, show a sub-population of aldehyde dehydrogenase (ALDH)     overexpressing TSCs. More specifically, ALDH1A1, a cytoplasmatic isoform of ALDH, proved to     be a novel stem cell marker in human GBM. In addition, ALDH1A1 has been shown to be a     mediator for resistance of GBM to temozolomide (TMZ) and a reliable predictor of clinical     outcome; prognosis of patients with a high level of ALDH1A1 expression was poor compared with     that of patients with low levels. Consequently, ALDH1A1 may serve as a potential target to     improve treatment of human GBM through inhibition of the enzyme.      Disulfiram (DSF) has been used for more than sixty years in the treatment of chronic     alcoholism because of the unpleasant symptoms it provokes after ethanol intake. The     underlying mechanism is believed to be the accumulation of acetaldehyde in the blood, due to     inhibition of the liver ALDHs. Actually, DSF is a strong inhibitor of ALDH1A1 and relatively     non-toxic at therapeutic (for chronic alcoholism) doses that can penetrate the blood-brain     barrier. In addition, DSF has been shown to be cytotoxic on GBM stem-like cells, inhibiting     the growth of TMZ resistant GBM cells and blocking self-renewal by ~100% , while it has been     identified as an inhibitor of human GBM stem cells in high-throughput chemical screens.     Interestingly, a number of these actions were copper-dependent.      In the current Phase II clinical trial, DSF/copper combination will be tested as an     adjunctive and concurrent chemotherapy in the treatment of newly diagnosed GBM. According to     our hypothesis, initiation of DSF chemotherapy after the resection of the tumor and before     the introduction of the standard radio-chemotherapy will inhibit ALDH1A1 of GBM TSCs making     them more susceptible to radio-chemotherapy and possibly reducing the recurrence rate of GBM.     On the other hand, the addition of copper will probably enhance the cytotoxic effects of DSF     possibly through augmentation of its pro-apoptotic and proteasomal inhibitory actions.   "
115206|NCT01777906|"     Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps.     Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary     medical management to prevent continued growth. More recently high dose topical nasal steroid     sprays are used. It is thought that the higher dose will penetrate the sinus cavities at an     increased dose and will allow for greater control of polyp growth. Safety studies have been     performed which have shown no suppression of the pituitary axis with long term high dose     topical steroid or changes in intraocular pressure. However, studies in efficacy are limited     despite their widespread use. The objective of this study will be to compare the     effectiveness of two topical nasal steroid sprays in patients with recurrent nasal polyps.   "
115207|NCT01777893|"     Type-2 diabetes is one of the fastest growing chronic diseases worldwide. This trend is     mainly driven by a global increase in the prevalence of obesity. The PREVIEW study has been     initiated to find out the most effective lifestyle-components (diet and physical activity) in     the prevention of Type-2 diabetes. The project consists of a randomized     lifestyle-intervention with the more specific aim to determine the preventative impact of a     high-protein and low-GI diet in combination with moderate or high intensity physical activity     compared with a moderate-protein and moderate GI diet in combination with the same activity     levels on the incidence of Type-2 diabetes in predisposed, pre-diabetic children, young and     older adults.      The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain,     Netherlands, UK) and Australia and New Zealand.      A total of 2,500 overweight or obese adult participants (25-70 y) as well as 150 children and     adolescents aged 10—18 y) will be recruited. All adult participants are first treated by a     low-calorie diet for 8 weeks, with an aim to reach ≥ 8% weight reduction. Children and     adolescents are treated separately with a conventional weight-reduction diet, with-out a     specific aim for absolute weight loss.      The adult participants are randomized into two different diet interventions and two exercise     interventions for a total of 148 weeks. This period aims at preventing Type-2 diabetes by     weight-maintenance (prevention of relapse in reduced body weight) and by independent     metabolic effects of diet and physical activity.      The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3     years (156 weeks) according to diet (high protein/low-GI versus moderate protein/moderate-GI,     adjusted for physical activity), based on a 75 g oral glucose tolerance test and/or HbA1c.      For children and adolescents:      Change in insulin resistance at 2 years after randomization to high protein versus moderate     protein diet, measured by insulin resistance analyzed by the homeostatic model (HOMA-IR) as     well as physiological improvement of health with respect to pre-diabetic characteristics.      Our hypothesis is that a high-protein, low-GI diet will be superior in preventing type-2     diabetes, compared with a moderate protein, moderate GI diet, and that high-intensity     physical activity will be superior compared to moderate-intensity physical activity.   "
115221|NCT01777698|"     Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of     patients with hepatocellular carcinoma are associated with cirrhosis.      Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into     the hepatic tumor where the principal artery is embolized.      Bioelectrical impedance bases its evaluation in a model where the body is conformed by two     different compartments: fat mass and fat free mass.      Bioelectrical impedance is complemented by vectorial analysis, which is independent to the     state of hydration and is helpful to monitor any changes in corporal composition. It can be     used as a control for the interpretation of the bioelectrical impedance.   "
115222|NCT01777685|"     The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral     administration.   "
115223|NCT01777672|"     Oropharyngeal dysphagia (OD) is a major complaint among many patients with stroke and causes     severe complications. There is no specific treatment for these patients. Impaired swallow     response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed     airway protection. Swallow response is initiated by sensory afferent fibers in the oropharynx     and cerebral cortex reaching the central swallowing pattern generator (CPG) in the medulla     oblongata and brainstem motor nuclei. Hypothesis: Stimulation of pharyngeal sensory afferent     fibers through TRPV1 receptors and electrical stimuli might enhance the stimulation of the     CPG and speed the swallow response. Long-term treatment of OD will improve clinical outcome     of stroke patients. Aim: To assess the effect of TRPV1 agonists (capsaicin) and that of     sensorial pharyngeal electrical stimulation (intrapharyngeal and transcutaneous) on VFS signs     and swallow response at 3, 6 and 12 months after treatment in stroke patients with     established OD. To compare the clinical effect of classical rehabilitation strategies with     that of these new afferent sensorial neurostimulation strategies in terms of nutritional     status parameters, incidence of aspiration pneumonia and/or low respiratory tract infection,     quality of life, and mortality. Methods: Clinical screening of OD with the volume-viscosity     swallow test and assessment by VFS and quantitative measurements of swallow response.     Randomized controlled trial assessing the effect of standard rehabilitation with that of     afferent sensorial neurostimulation strategies.   "
115224|NCT01777659|"     The investigators will test the hypothesis that transcutaneous electrical nerve stimulation     (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution     during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary     Arterial Bypass Graft Surgery (CABG).   "
115225|NCT01777646|"     The study will evaluate the safety, tolerability and therapeutic effects of transplantation     of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting     neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS).   "
115226|NCT01777633|"     Although DIPG is not curable, re-irradiation with a modest total dose and short treatment     time provides good palliation of symptoms, improves quality of life, delays disease     progression and has minimal and manageable toxicity.      Treatment plan:      At progression, full radiological and clinical documentation necessary including a     neurological exam by a neurologist will be done. Progressive patients will be referred to     radiotherapy.      Radiation guidelines:      30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed.     Radiation will be done in standard accelerators and according to standard guidelines used in     treatment for all brain tumor patients.   "
115227|NCT01777620|"     This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar     lines and crow's feet lines).   "
115228|NCT01777607|"     The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with     right ventricular failure.   "
115229|NCT01777594|"     Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the     third most common cause of death from cancer. Sorafenib is the only approved therapy for     treatment of advanced HCC, and there is a need to identify more drugs that are beneficial for     these patients without unacceptable side effects. Prodrug chemotherapy is an approach in     which an inactive non-toxic agent is administered to the patient and gets activated within     the body at specific locations, resulting in a higher concentration of the cytotoxic form at     a tumor location while avoiding general side effects. G-202 (mipsagargin) is an example of     prodrug chemotherapy. It is activated by Prostate Specific Memory Antigen (PSMA), which is     expressed by some cancer cells and in the blood vessels of most solid tumors, but not by     normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug     G-202 will allow the drug to kill cancer cells. This study will evaluate the activity and     safety of G-202 in patients with hepatocellular carcinoma who have progressed after taking     sorafenib. The study will evaluate clinical activity and safety of G-202 administered by     intravenous infusion on three consecutive days of a 28-day cycle.   "
115230|NCT01777581|"     This study investigates whether milnacipran reduces radicular pain (sciatica) in patients     with lumbosacral disc disease.   "
115231|NCT01777568|"     Our primary objective is to develop a clinical pathway for care of patients having colorectal     surgery at the Clinic. In particular, the investigators would like to determine what     intraoperative concentration of oxygen is optimal in our patients.   "
115233|NCT01777542|"     Investigators are recruiting children for a clinical trial using the medication recombinant     human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with     Rett syndrome (RTT). While IGF-1 is approved by the Food & Drug Administration (FDA) for     certain use in children, it is considered an investigational drug in this trial because it     has not previously been used to treat RTT. Information from this study will help determine if     IGF-1 effectively treats RTT but will not necessarily lead to FDA approval of IGF-1 as a     treatment for RTT.   "
115245|NCT01777373|"     The purpose of this study is to determine whether extension of the conducting airways into     the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary     Fibrosis, a disease wherein normal lung structures are destroyed and replaced by     non-functional scar tissue.   "
115246|NCT01777360|"     To determine, from patients presenting severe asthma and an increase in bronchial smooth     muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY     should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations,     and improve respiratory function   "
115234|NCT01777529|"     Whether the lower immunogenicity of the mumps component obtained in clinical studies with the     MMR in Brazil, due to the multidose presentation. Investigations were made on factors that     could interfere with immunogenicity of mumps component, as the kits used for the immunoassay     method, and potency of the vaccine, but no explanation was found. This study aimed to     investigate the hypothesis that the lower immunogenicity of the mumps component of the MMR     Bio-Manguinhos vaccine, is due to the multidose presentation.      The Main objetctive is evaluate the immunogenicity of MMR after one dose in children 12 to 23     months of life, comparing the performances multidose vial (10 doses per vial of vaccine     produced in Bio-Manguinhos/Fiocruz through technology transfer from GlaxoSmithKline     Laboratory - GSK) and single dose vial (1 dose per vial of vaccine produced by GSK).   "
115235|NCT01777516|"     This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and     its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic     acid. The study consist of two parts of in-vitro study as follows;        -  Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor          and its active metabolite.        -  Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor          and its active metabolite and their effect on the pharmacodynamics of salicylic acid on          platelet aggregation tests with the agonist of arachidonic acid.   "
115236|NCT01777503|"     The objective of this study is to compare reduced-dose prasugrel and standard dose     clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS)     and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial     will be the one-year composite of (all-cause)death, myocardial infarction, stroke and     re-hospitalization due to cardiovascular reasons or bleeding.   "
115237|NCT01777490|"     The purpose of this study is to evaluate a caregiver skill training program (HI-FIVES),     offered as a part of a randomized control trial to caregivers of Veterans referred to home     and community-based long-term care. Of primary interest is to examine whether participating     in HI-FIVES leads to clinically significant increases in days spent at home for Veterans     compared to caregivers in usual care. The investigators aim, through the training, to     decrease the number of days over 12 months post-intervention that Veterans spend in the     emergency department, hospital, or nursing home. Days spent in these settings reduces the     Veteran's quality of life and increases health care costs to the VA. The investigators also     will evaluate whether caregivers in HI-FIVES have clinically significant reductions in     depressive symptoms post-intervention compared to caregivers in usual care.   "
115238|NCT01777477|"     The purpose of this study is to evaluate the safety by defining the maximum tolerated dose     (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy of     combined systemic Gemcitabine and Chloroquine. In addition, the influence of the treatment on     the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic cancer will     be assessed within a translational objective.        -  Trial with medicinal product   "
115239|NCT01777464|"     In order to evaluate the effects a nasal provocation on the activation of different brain     regions, the investigators want to set up a clinical trial investigating the short-term     effects of a nasal histamine provocation in healthy volunteers and allergic patients while in     supine position under the functional MRI device in order to visualize different brain     regions.   "
115240|NCT01777451|"     Whole body MRI will be performed in patients with neurofibromatosis Type 1      PURPOSE 1:      To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or     malignant peripheral nerve sheath tumors. All patients will be scanned two years after the     baseline whole body MRI to investigate to investigate the changes of total tumor load.      PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas      PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath     tumors and neurofibroma.      PURPOSE 4 : correlation between histopathology of the surgically resected     neurofibroma/malignant nerve sheath tumors and MRI findings   "
115241|NCT01777438|"     Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an     allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy     nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life.     Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy     (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so     far.   "
115242|NCT01777425|"     State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS)     provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and     chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can     alleviate symptoms associated with AR and RS, and most patients with RS benefit from     endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR     and CRS continue to experience bothersome symptoms despite adequate treatment. This group     with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic challenge     (3).   "
115243|NCT01777412|"     This is a phase 1b interventional trial of bevacizumab (Avastin®) to evaluate the     tolerability/safety and preliminary efficacy of bevacizumab (Avastin®) as add-on therapy for     treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO)     and neuromyelitis optica spectrum disorder (NMOSD). A single infusion of Avastin® is added to     standard-of-care high dose steroids and an additional dose of Avastin® is added to plasma     exchange (if necessary). The primary outcomes are clinical changes in the Expanded Disability     Severity Scale, Timed 25-foot Walk and Low Contrast Visual Acuity, MRI parameters and safety.   "
115290|NCT01776788|"     The randomized, controlled trial is to investigate and evaluate the effects of short-term     continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell     function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2     diabetic patients.   "
115244|NCT01777386|"     Tissue expansion methods have been recommended as a means of improving the clinical results     with perforator flaps but in plastic surgery literature there are few clinical trials     supporting this opinion. The purposes of this clinical study are to address the ''preexpanded     perforator flap concept'' by demonstrating a case series of relevant reconstructive     procedures and to evaluate the perforator vessel changes that happen during the expansion     periods of various perforator flap donor sites.   "
115250|NCT01777308|"     The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a     booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary     vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and     Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the     long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.      This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).   "
115251|NCT01777295|"     This study aims to develop innovative immunological read-outs and new technologies in order     to further characterise the early immune response and its kinetics as well as the adaptive     immune responses to adjuvanted vaccines.      This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults     vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals'     Adjuvant System.   "
115252|NCT01777282|"     This study is designed to examine the long term safety and efficacy of weekly subcutaneously     injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in     Japanese subjects with type 2 diabetes mellitus.   "
115253|NCT01777269|"     This is an European double-blind, placebo controlled parallel group comparison of DUODART     (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and     placebo.      PRIMARY OBJECTIVE:      To assess the change in sexual function from baseline to 1 year in sexually active men with     at least moderate BPH who are treated with DUODART, compared to men treated with placebo .   "
115254|NCT01777256|"     This is an adaptive, dose ranging, Phase II study to investigate the relationship between     repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients     with active systemic lupus erythematosus (SLE). This study will also investigate the safety     and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses     will be conducted. These are to monitor the pharmacodynamic effect and safety following 2     weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184     following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry     criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive     GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400     mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will     be administered orally up to 12 weeks.      Subjects who complete the study will participate in the study for approximately 21 weeks.   "
115255|NCT01777243|"     The study will be conducted in two parts. The first (Part A) will be an open label single     dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5     milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose     levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be     administered at variable doses until the concentration of the serum amyloid P component     monoclonal antibody (SAP mAb) has fallen below 100 nanogram/millilitre (ng/mL). Decisions     about these next dose levels will be made following safety review of the prior subjects'     data; dose levels may be changed (increased and lowered) and dose levels may be repeated     depending on the observed safety such that Part A extension study may be performed. In     addition, pharmacokinetics of GSK2315698 (SAP depleter) and GSK2398852 (anti-SAP mAb), and     circulating SAP concentrations will be assessed. Dose escalation in Part A will continue to     the highest well tolerated dose or the highest allowable dose. Subjects will be closely     monitored and will undergo Equilibrium contrast Magnetic Resonance Imaging (EqMRI) including     organ volume, Elastography and Liver Biopsy if required.      Part B will be a randomized partially blinded part with the principal objective of assessing     the dose response of the GSK2398852 in more detail. Subjects will be assigned to one of     approximately 5 dose groups from Part A. The precise selection of numbers of subjects and     dose levels will be informed by the results from Part A.   "
115267|NCT01777087|"     This study has two purposes: first, to locate and identify the brain activation (the areas     of the brain) which respond to pain; and second, to look at how brain activation is     influenced by a person's genetics (the traits they inherited from their parents). A Magnetic     Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an     x-ray, but based on different scientific principles) that will be used to determine which     areas are active. The hypothesis is that the variation in brain activity between people can     be partially explained by genetic differences. This study consists of an two pain tasks     applied during a one time visit to the MRI suite. There are no followup visits.   "
115256|NCT01777230|"     Objective of the study: To study the concordance of sentinel node (SN) localization between     preoperative Magnetic Resonance Lymphangiography and SPECT-CT SN mapping and the     intra-operative SN procedure for low stage cervical cancer.      Background: The SN procedure for surgically treated cervical cancer is promising.     Unfortunately, efficient and direct intra-operative SN localisation, without an extensive     surgical exploration, remains a challenge even with combined use of patent blue dye en     technetium-99m (99mTc). Preoperative imaging (= mapping) with 99mTc based SPECT-CT, which is     increasingly adopted, has partly alleviated this problem. The investigators aim to     investigate the feasibility of a new SN mapping modality, which visualises the (sentinel)     lymph nodes using a Magnetic Resonance Imaging (MRI) technique (so called; Magnetic Resonance     Lymphangiography), and compare it to SPECT-CT.      Design: Prospective, feasibility type diagnostic study. 40 subjects targeted. Via vaginal     speculum exam, a specific MRI contrast-agent will be intracervically injected. Subsequently,     on a wide bore 1.5T MRI system multiplanar imaging is performed, followed by a blinded review     (experienced radiologist) for bilateral SN localization. Standard care with a preoperative     SPECT-CT (after intracervical 99mTc administration). A blinded nuclear medicine specialist     will localize the SN on the SPECT-CT images. Open or (robot-assisted) laparoscopy performed     for localization of the blue stained and/or 99mTc-hot SN. Excision of the SN with freeze     sectioning and histological review. Statistical analysis with intrapatient testing for     concordance of MR Lympangiography and SPECT-CT based SN localization against the reference     standard: the intra-operative sentinel node procedure.   "
115257|NCT01777217|"     The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in     treating over-active bladder symptoms during radiation therapy of the prostate.   "
116626|NCT01759368|"     In the study benefits of using mobile phone assisted remote patient monitoring including     self-measurements of blood pressure, heart rate and weight as well as monitoring of personal     health status are investigated in the care of heart failure patients.   "
115258|NCT01777204|"     Gastrointestinal (GI) complications after renal transplantation are commonly reported as side     effects of immunosuppressive agents. Despite this, motility disorders have been scantily     studied. Alternating Current Biosusceptometry (ACB) are biomagnetic sensors designed for a     wide range of applications. In clinical practice, their non-invasive and radiation free     features provide an excellent approach for monitoring of GI transit as alternative to     scintigraphy and breath tests. The aim of this study is to examine GI transit and motility of     solids in stable renal transplant recipients to determine the potential influence of     immunosuppressive therapy on gastrointestinal parameters.   "
115259|NCT01777191|"     The purpose of this study is to evaluate the serum concentration of ixekizumab after     administration using either prefilled syringe or auto-injector in participants with moderate     to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety     extension.   "
115260|NCT01777178|"     This study will compare acid-base changes during hemodialysis treatments with a standard     dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that     limit equilibration of the bicarbonate concentration in a patient's blood with that in the     dialysate.   "
115261|NCT01777165|"     This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury     in patients undergoing high risk cardiac surgery.   "
115262|NCT01777152|"     This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the     efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care     CHOP in patients with CD30-positive mature T-cell lymphomas.   "
115263|NCT01777139|"     This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term     safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy     in adult Asian subjects with drug-resistant partial-onset seizures (POS).   "
115264|NCT01777126|"     After radical cystectomy, postoperative ileus (POI) is a common complication resulting in a     delayed oral nutritional intake with prolonged recovery and hospital stay. However, it is     questionable if nutritional support by routine use of parenteral nutrition (PN) is     justifiable.      A non-randomized before-after trial was conducted. Patients treated with an elective regular     radical cystectomy and without preoperative contra-indications for enteral nutrition were     eligible. In the control group, PN was initiated immediately after the procedure and     continued until resumption of diet. In the interventional group, an ONP was implemented. PN     could be initiated if oral intake was still insufficient after five days. The primary end     point was the postoperative length of stay.   "
115265|NCT01777113|"     Stroke is a global health-care problem that is common, serious and disabling. In most     countries, stroke is second or third most common cause of death and one of the main causes of     acquired adult disability. After stroke, patients remain at continued high risk for recurrent     stroke as well as for myocardial infarction and cardiac death. After completion of     conventional physical therapy, there are no empiric recommendations and few resources     promoting regular exercise during the chronic stroke period.Interventions to improve     cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many     rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies     based on neurodevelopmental principles such as the Bobath concept. These standard therapies     are an insufficient stimulus to increase fitness levels after stroke.   "
115266|NCT01777100|"     The appropriate management of postoperative pain is recognized as an important clinical     challenge with implications beyond humanitarian issues. Evidence shows that effective     postoperative analgesia is associated with physiological benefits to the patient, shortened     length of hospital stay and lower rates of in-hospital complications, such as pneumonia,     delirium and persistent pain after surgery. However, despite the availability of several     analgesic drugs and strategies the prevention and treatment of postoperative pain is often     suboptimal. Remifentanil is a potent short acting opioid commonly used in continuous infusion     for anesthesia for several surgical procedures. Remifentanil has been extensively advocated     as a means to provide quick patient awakening in the immediate postoperative period with a     very low risk of respiratory depression. Yet it does not provide residual analgesia and     postoperative pain is a major concern. In order to overcome this limitation, practicing     anesthesiologists frequently give patients a single dose of Sufentanil, a long acting opioid,     during the induction of anesthesia where Remifentanil will be used in continuous infusion.     However the effectiveness of this strategy still lacks evidence from controlled clinical     trials.   "
125495|NCT01642459|"     The investigators hypothesis that aneurysms and stenoses will be decreased if the direction     of inserted arterial needle were same as the direction of blood flow, when compared to the     opposite direction puncture.   "
115269|NCT01777061|"     When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and     magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes,     but are not specific as to whether the lymph nodes are malignant or benign.      While positron emission tomography (PET) utilizing radioactive glucose (FDG) has     revolutionized staging, restaging, and monitoring response to therapy in many prevalent     cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma,     findings with prostate cancer have proven less sensitive because prostate cancer has a lower     avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the     cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in     detecting prostate cancer.      This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in     identifying recurrent prostate cancer.   "
115270|NCT01777048|"     The overarching aim of the proposed study is to assess whether omega-3 fatty acids     supplementation can augment the effects of methylphenidate in children with ADHD. The     investigators hypothesized that omega-3 fatty acids supplementation will be associated with     improved ADHD symptoms.   "
115271|NCT01777035|"     To study all ICU patients with an independent baseline functional status , who experience a     critical illness requiring intubation and mechanical ventilation evaluating long-term     cognitive and executive function and long term cost effectiveness in survivors who required     mechanical ventilation.   "
115340|NCT01776138|"     The purpose of this study is to create a registry of older patients undergoing surgical     and/or medical treatment for bladder cancer. The registry will record side-effect and     outcomes related to the treatment using different surveys and biological measures.   "
115272|NCT01777022|"     Rates of stillbirth in Scotland are among the highest in resource rich countries. The     majority of stillbirths occur in normally formed infants, with (retrospective) evidence of     placental insufficiency being the commonest clinical finding. Maternal perception of     decreased fetal movements appears to be an early biomarker both of placental insufficiency     and subsequent stillbirth.      The study proposed here will test the hypothesis that rates of stillbirth will be reduced by     introduction of a package of care consisting of strategies for increasing pregnant women's     awareness of the need for prompt reporting of decreased fetal movements, followed by a     management plan for identification of placental insufficiency with timely delivery in     confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar     package of care in Norway but the efficacy of this intervention (and possible adverse effects     and implications for service delivery) have not been tested in a randomized trial.      The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland     and Ireland will be randomized to the timing of introduction of the care package. Outcomes     (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's     detailed routinely collected maternity data, allowing the investigators to robustly test the     hypothesis. A nested qualitative study will examine the acceptability of the intervention to     patients and health care providers and identify process issues (barriers to implementation).   "
115273|NCT01777009|"     Short and long term outcomes of total knee arthroplasty patients surgically exposed with     patellar eversion are compared to those patients exposed by laterally retracting the patella.     It was hypothesized that there would be no difference.   "
115274|NCT01776996|"     This is an open-label protocol designed to provide continued access to maraviroc to only     those subjects who have completed previous studies of maraviroc and continue to receive     clinical benefit.   "
115275|NCT01776983|"     Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected     skin by Siascopy. Immunocompromised patients (for more than seven years) compared to     immunocompetent patients.        -  Trial in the field of transplantation / xenotransplantation   "
115276|NCT01776970|"     The clinical primary hypothesis is that there will be a difference between a Cannabis Sativa     extract and placebo in their effect on spasticity in Motor Neuron Disease (MND) patients with     signs of involvement of the upper motor neuron (UMN) resulting in disabling spasticity.      Secondary goals of the study are to evidence of improvement in other symptoms (in particular     pain), and to show favourable trends on functionality measures. Finally, cannabis based drug     safety and tolerability will be studied through vital parameters (including weight and     pulmonary function) measurement, and analyzing ALS function rating scale progression slope     hopefully, showing a slowing of the functional values decrease, owing to cannabis     neuroprotective effects)   "
115277|NCT01776957|"     The rate of repeat abortions will be lowest in those women who choose immediate insertion of     an IUD post-abortion versus those who immediately choose oral contraceptive pills and those     who indicate all other contraceptive choices including no contraception The provision by the     health system of IUDs for immediate insertion will result in the lowest health system costs.   "
115278|NCT01776944|"     High prevalence of obesity in children has increased associated complications such as type 2     diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts     caloric intake by estimating the resting and total daily energy expenditures.Estimation of     energy needs is most commonly done using predictive equations. Reliable and valid energy     requirements can be obtained using a traditional metabolic system, however this is an     expensive option. Handheld indirect calorimeters may be a good alternative to measure energy     needs. Several studies have been conducted to determine the validity and accuracy of handheld     calorimeters in adults and health children, however, to the best of our knowledge, there are     no such studies in the overweight and obese pediatric population.      The purpose of this study is to validate a handheld indirect calorimeter against a     traditional metabolic system in overweight and obese children.      If handheld calorimeters can accurately measure resting energy expenditure in overweight and     obese adolescents, dietitians will have an opportunity to tailor pediatric weight management     interventions based on parameters that are unique to each individual.   "
115328|NCT01776294|"     Student Investigator = Thakkallapalli Zeeshan Muzahid. The study aims to assess the     prevalence of prehypertension among medical students of Andhra Medical College,     Visakhapatnam, India and its association with other cardiovascular risk factors - overweight     /obesity, diabetes, lipid profile.   "
115336|NCT01776190|"     The investigators are conducting an open-label clinical trial determining the effects of UVA1     phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE)     subjects indicates that this treatment is likely to be effective in treating cutaneous lupus     with few side effects. The fact that most CLE patients are seen at dermatology clinics also     increases the usefulness of this study because there is a large probability that phototherapy     treatment will be accessible for many of the patients that stand to benefit from it.   "
115279|NCT01776931|"     Amino acids are building blocks of protein in our body. It is important that pregnant women     eat adequate amount of protein/amino acids to ensure healthy growth and development of the     fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and     not much in plant foods such as wheat. Currently , it is not known how much lysine is needed     to eat during pregnancy.      Current Dietary Reference Intake recommendations for amino acid requirements are based on     non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators     knowledge, there is no scientific information regarding the amount of lysine needed at     different stages of pregnancy.      The investigators hypothesize that current recommendations for lysine intake in pregnant     women are underestimated. The investigators also hypothesize that the lysine requirements     will be greater during the later stages of pregnancy, compared to early stages.      The purpose of this study is to determine lysine requirements in healthy pregnant women     19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator     amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks     last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.   "
116135|NCT01764789|"     This pilot clinical trial studies stress reduction in improving quality of life in patients     with recurrent gynecologic or breast cancer. Participating in a stress reduction program may     help improve quality of life in patients with gynecologic or breast cancer.   "
115280|NCT01776918|"     Metabolic diseases and mitochondrial disorders are caused by genetic mutation which lead to     disruptions in energy producing pathways in our body. Enough energy or calories must be given     in the diet to ensure normal growth and development. Currently, energy needs for patients     with metabolic and mitochondrial diseases are not measured, but is estimated using a     mathematical equation based on healthy children. This may lead to under feeding or     overfeeding of calories, and has negative nutritional implications.      The clinical standard for measuring energy needs is the use of indirect calorimeter.The     indirect calorimeter takes individualized measurements for each patient and therefore will     enable dietitians and clinicians to provide sufficient calories in the diet to better manage     the disease and promote normal growth and development.      We believe daily energy requirements will vary within metabolic diseases (Phenylketonuria)     and mitochondrial disorders (mitochondrial fatty acid oxidation defect, POLG1 mutation etc.).      The objective of this preliminary study is to measure resting energy expenditure in children     living with metabolic and mitochondrial conditions and data obtained will be used to generate     future hypothesis and will form a basis for future studies.   "
115282|NCT01776892|"     Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily     activities. Treatment traditionally involves cutting out diseased tissue, however this can     cause damage to important structures in the hand and results in large scars.      Needle aponeurotomy and collagenase injections are newer treatments that are thought to be     safer. These treatments allow quicker return to function. One drawback is that Dupuytren's     deformity may return more quickly than when all diseased tissue is surgically cut out.      This research study is designed to compare the effectiveness of needle aponeurotomy and     collagenase injection for Dupuytren's disease. This study will determine which procedure     gives the best results- either needle aponeurotomy, collagenase injection, or both procedures     in combination. Participants will be evaluated to see how they do in the long term.   "
115283|NCT01776879|"     This study will examine speech intelligibility of early parkinson's disease (PD) patients,     early PD patients and first degree relatives. The investigators hypothesis that advanced PD     patients will present decreased speech intelligibility more than early PD patients. Speech     intelligibility of first degree relatives will be normal.   "
115284|NCT01776866|"     The investigators hypothesized that dual-axis rotational coronary angiography was     non-inferior to standard coronary angiography with respect to diagnosis of coronary artery     disease.   "
115285|NCT01776853|"     The purpose of the study is to investigate if patients with Irritable Bowel Syndrome (IBS)     who also report bloating are more likely to report clinically important gastrointestinal     symptoms after consuming fructose or fructans than after consuming glucose. We will also use     MRI imaging to investigate the mechanisms by which those symptoms might be caused.      We will also study a parallel group of age and gender frequency matched healthy volunteers to     provide descriptive statistics on a likely reference range for the healthy population.      Irritable Bowel Syndrome (IBS) is a common chronic condition, the main features of which are     pain in the abdomen, an erratic bowel habit and sometimes bloating. Recent research has found     that certain carbohydrates (sugars) in the diet can cause symptoms such as discomfort,     bloating and wind/gas in people with IBS. These sugars are not well digested in the small     bowel. They move to the colon (large bowel) where bacteria act on them by fermentation,     producing gas. Some of the gas is absorbed and breathed out through the lungs, where we can     measure it. The rest is released as flatulence/ wind, or occasionally belching. People     without IBS rarely get symptoms after consuming these sugars. We want to find out what is     different in IBS sufferers.      We will study fructose and fructans, sugars found in fruit, vegetables and wheat. Fructose     draws water into the small bowel but fructans do not so we can compare effects on the small     bowel and colon. Participants will attend three times, and on each occasion consume a drink     containing either fructose, fructans, or glucose - a sugar that does not cause symptoms.     Neither they nor the investigators present will know which drink is which. They will record     their symptoms over the next 5 hours. We will observe how many report a clinically important     increase in symptoms.      To look at what is happening in the bowel we will use a technique called Magnetic Resonance     Imaging (MRI). We want to see if more gas, or water, builds up in people with IBS than in     healthy volunteers. We will also measure the amount of hydrogen released in the breath to see     if this is could be a simple bedside test that agrees with the MRI findings      Finding differences between the response of participants to fructose, fructans and glucose     could change the way we advise patients, and could lead to the use of MRI as a test for IBS.   "
115286|NCT01776840|"     The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in     combination with bendamustine and rituximab in patients 65 years of age or older with newly     diagnosed mantle cell lymphoma.   "
115287|NCT01776827|"     To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular     dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh at a University Hospital.   "
115288|NCT01776814|"     Chronic hepatitis B virus infection is an important cause of morbidity and mortality.     Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B     virus infection. In this study, the investigators will try to make comparison between     Entecavir and Tenofovir and investigate the efficacy.   "
115289|NCT01776801|"     The purpose of this project is to determine during moderate rise of intracranial pressure     (ICP) in awake patient, the change in autonomic function and its influence on cerebral and     systemic haemodynamics.   "
115291|NCT01776775|"     Postoperative seroma formation is one of the most common complications after ventral hernia     repair with mesh. Although some seromas may not have clinical impact postoperative seroma     formation often causes pain and discomfort and may even compromise wound healing. Abdominal     binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are     commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain     and discomfort after operation. The primary aim of the present study is to investigate the     effect of postoperative abdominal binders after laparoscopic incisional hernia repair on     postoperative pain, discomfort and quality of life. Secondary, we register seroma formation.     A randomized, controlled, investigator-blinded study supplemented with blinded statistical     analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to     abdominal binder or no abdominal binder (controls). The abdominal binder is worn from     immediately after the operation and continuously for 7 days and nights. All patients have a     standardized operation with standardized intra- and postoperative medication regimen.     Endpoints measurements are clinically detectable seroma formation scored with seroma     classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and     quality of life scored with EQ-5D, recurrence and other complications are also registered.     Patients are followed until 90 days after the operation.   "
115382|NCT01775592|"     Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the     successful treatment of malaria, has been confirmed in Cambodia. There are few reports from     neighbouring countries about delayed parasite rates. The investigators therefore aim to     assess parasite clearance in malaria patients in central Vietnam when treated according to     national standard guidelines.   "
115292|NCT01776762|"     Based on an established Follow-home-programme offered at discharge from hospital the aim of     this study is to test a model of how nutritional intervention in elderly patients can be     systematized and quality assured in the transition between sectors. Furthermore the aim is to     demonstrate that this model has a positive effect on the functioning and well-being of the     elderly patient.      The purpose of the Follow-home-programme is to facilitate the transition of the elderly     patient between hospital and private home in order to follow-up on any medical, nursing- or     retraining-related intervention necessary to the rehabilitation of the patient. However this     offer does not focus on nutrition in particular. This is a problem as many elderly patients     are known to develop a poor nutritional status due to low appetite, disease etc. Our     hypothesis is that adding a systematic nutritional focus to the Follow-home intervention     programme will promote the rehabilitation of the elderly patient further.      The nutritional intervention in our study will focus on improving energy- and protein intake     and we will measure the effect on the patient's functional abilities, quality of life and     rate of hospital readmissions. The intervention model will be based on individualized     nutritional counselling by a registered dietician in the patients home.   "
115293|NCT01776749|"     Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of     chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord     Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly     have dominant leg pain, however a significant percentage of FBSS patients has a more     pronounced back pain and are commonly excluded from SCS as it is often inadequate in     relieving both the back and leg pain components. Recently some reports showed the benefit of     subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been     confirmed by a feasibility study performed by our group. The aim of the randomized controlled     study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives     an inadequate back pain relief.      Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back     pain is more effective in treating low back pain (i.e. >50% pain reduction) than SCS alone.   "
115294|NCT01776736|"     For AIS, the caring of patients with spinal deformities has a long and varied history. Severe     spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to     death from cardiopulmonary failure. Therefore, surgery is generally suggested when the     curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of     orthoses treatment on patients and its poor compliance has been a well-recognised problem.     Some orthotic research studies indicate that early intervention of spinal deformities is     particularly desirable. Taking into consideration current clinical practices, if the curve is     less than 20 degrees, even if the child is at a high risk of progressive spinal deformity     during the age of 10-16 at puberty, treatment is nothing more than just observation.      This project aims to combine clinical experience with textile and materials sciences to     research and develop a posture correction girdle for adolescents with early scoliosis. As a     result, this will reduce the future likelihood of brace wear or surgery.      In this study, the eligible subjects will be given tailor-made posture correction girdles to     wear it 8 hours daily. Monitoring and observation will be provided during the six months     girdling period. Data will be collected before and after the girdling by X-ray radiograph for     analysis, in order to comparison the spine curvature condition. Locomotion of the subject     with and without wearing the posture correction girdle will also be reference.   "
115295|NCT01776723|"     The purpose of this study is to find out if treating Chronic Myelomonocytic Leukemia (CMML)     with a study drug [ruxolitinib] can improve outcomes of patients with CMML. The first step of     the study is to learn the dose of ruxolitinib that is tolerable (bearable). It has already     been studied in a number of patients with different bone marrow diseases and is approved for     the treatment of a disease called Myelofibrosis; however, it is not approved for treatment of     CMML. It is given orally (by mouth). Most people tolerate it well but the tolerability has     not been determined in patients with CMML. We will be testing different doses to determine     how much of the medication people can tolerate (bear) before they develop side effects.   "
115313|NCT01776489|"     Food allergies represent an increasing health concern in the industrialized countries and     especially affect pediatric patients. In this population adverse reactions against food     compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical     markers predicting disease severity and symptoms are missing to date.      Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P),     play an essential role in allergy. It was reported that asthmatic patients have higher S1P     levels in bronchiallavage fluids after allergen challenge. First experimental studies     revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in     our recent mouse study that S1P homeostasis is pivotal for food allergy induction and     effector cell response. Therefore, it is the aim of the presented pilot project to evaluate     whether S1P serum titers are altered in food allergic children and if the S1P levels     correlate with the outcome of anaphylaxis during double blind placebo controlled food     challenges (DBPCFCs).   "
115296|NCT01776710|"     A primary therapeutic goal for patients with intermittent claudication (IC) is to regain lost     physical function through exercise rehabilitation. Supervised exercise programmes can     markedly improve walking capacity, but these are resource intensive, National Health Service     provision is limited, and patients cite accessing services as a barrier to participation.      Increasing walking activity via a structured education programme might be a pragmatic     solution for improving walking capacity, health and wellbeing in patients with IC; however,     further research is needed to substantiate this. Hence, the aim of this project is to develop     a pragmatic education programme to increase walking in these patients and to collect data on     its feasibility to inform the development of a definitive trial investigating clinical and     cost effectiveness.      Focus groups will be conducted to inform the development of the education programme.     Programme components will be theoretically-underpinned and evidence-based. The development of     the programme will be an iterative process involving pilot work, feedback, evaluation, and     revision. The programme will then be assessed in a randomised controlled pilot study with     6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain     preliminary data of its impact on important outcomes (daily steps/physical activity, walking     capacity, quality of life, illness perceptions).   "
115302|NCT01776632|"     The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas     likely contributes to the high rates of cancer and other chronic diseases in this population.     The goals of the current study, based largely upon the core principles of the Social     Ecological Model, are to design, implement, and evaluate an innovative multi-level     intervention promoting physical activity among churchgoing Latinas.      The evidenced-based intervention targets three tiers of environmental influences (i.e.,     church, immediate neighborhood surrounding the church, and community) on activity, as well as     MVPA-related personal factors (i.e.., intra/interpersonal, cultural, and perceived     environmental variables). The physical activity intervention will be compared with an     attention-control condition providing health education on cancer prevention and control via     screening.      Sixteen churches will be randomly assigned to either the physical activity intervention or     the attention-control condition. The primary aim of the study is to determine whether a     multi-level intervention will increase MVPA among Latina churchgoers in the intervention     condition relative to the attention-control condition.   "
115303|NCT01776619|"     Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young     healthy volunteers toghether with food effect on relative bioavailability of solid     formulation after single dose.   "
115304|NCT01776606|"     This study will evaluate the efficacy and safety of botulinum toxin type A compared to     placebo control for the treatment of moderate to severe crow's feet lines.   "
115305|NCT01776593|"     To identify the bladder diary parameters that are best correlated to VSD.   "
115306|NCT01776580|"     Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction,     and analyzing the association will be helpful to identify the indication of proper     management. Therefore, the aim of this study is to identify the above associations by     perineal sonography.   "
115307|NCT01776567|"     The purpose of the trial is to directly compare the Cobalt Chromium platform     everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform     everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position     with the heart blood vessel and extent of tissue coverage (at 6 months) using optical     coherence tomography.      Hypotheses:        1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on          stent apposition measured using OCT.        2. Stent design and alloy composition have a direct influence on radial support and          scaffold shrinkage.   "
115308|NCT01776554|"     Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived     influenza vaccine in children.   "
115309|NCT01776541|"     Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived     Influenza Vaccine in Adult Subjects.   "
115310|NCT01776528|"     The purpose of this study is to determine the safety and tolerability of NGM282, both single     dose and multiple doses, in normal healthy adult participants.   "
115311|NCT01776515|"     The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen     SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.   "
115312|NCT01776502|"     The purpose of this study is to evaluate the evolution of the non specific symptoms for 116     patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A     clinical score predicting clinical improvement at one year will be created.   "
115327|NCT01776307|"     This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab,     panitumumab or capecitabine in patients with advanced colorectal cancer.   "
127271|NCT01619189|"     Transplantation of allogeneic or autologous limbal epithelial stem cells cultured on human     amniotic membrane with no feeders in eyes with total limbal deficiency. Prospective     non-comparative monocentric study.   "
115314|NCT01776476|"     The purpose of this study is to find out if giving certain amino acids to critically injured     patients can improve their condition or recovery, and lower their blood sugar and insulin     needs. Amino acids are the 'building blocks' of proteins. The amino acid compound used in     this study is called alanyl-glutamine dipeptide, also known as Dipeptiven® or glutamine.     Glutamine is investigational, meaning not approved by the Food and Drug Administration (FDA)     for intravenous use. However, it is approved by many countries in Europe, Asia and South     America. Several studies suggest that giving glutamine has certain benefits in patients who     need intensive care. In a study done at Emory University Medical Center using the same dose     of glutamine, the number of hospital infections was lower in patients who had had cardiac,     blood vessel or intestinal surgery compared to similar patients who received standard     feedings without glutamine. No side effects were thought to be due to giving glutamine in     that small study. This study is only being done at Vanderbilt University. The investigators     plan to enroll 24 patients in the Trauma ICU over the next 12 months.   "
115315|NCT01776463|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics     (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.   "
115316|NCT01776450|"     To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of     the clinical protocol through compassionate use.   "
115317|NCT01776437|"     This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on     the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male     subjects.   "
115319|NCT01776411|"     Phase I portion:      To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma     patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day)     for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics.      Phase II portion:      To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen     determined in the phase I portion. The primary efficacy endpoint shall be objective response     rate (ORR).   "
115320|NCT01776398|"     The purpose of this study is to obtain biologic materials from the blood, airways and/or     urine of normal individuals and individuals with lung disease. The normal are used to     establish a set of normal ranges for various parameters. These provide control information     when compared to individuals with various pulmonary diseases, and will help in understanding     of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that     the pathologic morphological changes in the airway epithelium must be preceded by changes in     the gene expression pattern of the airway epithelium and potentially in macrophages.   "
115321|NCT01776385|"     Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early     diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare     distant metastases. There is now a sizable body of evidence that metastases could develop     from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive     and specific detection of CTC in blood is considered as a potentially relevant predictive     biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has     not yet been evaluated.      Indeed, the main goal for preoperative detection of CTC is to identify patients with high     risk of recurrence after surgery, in order to perform more adapted therapeutic strategy.     Despite several studies reported about CTC detection, methodological aspects concerning     sensitivity, specificity and reproducibility have prevented a clear appraisal of their     clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic     value of CTC in MPM by a double approach. In our setting, cytopathological analysis of     circulating non hematological cells (CNHC), of epithelial origin, isolated according to their     size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection,     identification and enumeration of circulating epithelial cells in peripheral blood     (CellSearch method) is considered a promising approach.   "
115322|NCT01776372|"     The chest cavity contains a small amount of fluid (pleural effusion). In normal circumstances     this fluid is kept in balance. When surgery is performed on the lung, there can be     accumulation of more fluid due to many causes. In order to drain this additional amount of     pleural fluid, chest tube(s) are left in the thoracic cage after a lung resection procedure.     The investigators are attempting to reduce the amount of pleural fluid production and     formation by using a more balanced thoracic drainage system, which adjusts the amount of     suction depending on the needs of the patient. That way, the amount of inflammation in the     thoracic cage might be smaller, and hence less fluid will be formed. By this, the     investigators are hoping that the chest tubes can be removed earlier, and the patients can be     discharged faster and will potentially have a lower rate of re-admission to the hospital     after surgery due to problems related to the fluid in the thoracic cage.   "
115323|NCT01776359|"     A four week intervention will take place with the participants. They will undergo 6 days a     week of high intensity training. They will also be at a 40% energy deficiency. One group will     have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis     that the participants with the higher protein will retain more lean mass.   "
115324|NCT01776346|"     The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more     effective targeted screening strategies and treatment options for Barrett's esophagus and     esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a     platform. Examples of analyses could include identifying genetic determinants and biomarkers     that predict BE, progression of BE to EAC, as well as the response to therapies.   "
115325|NCT01776333|"     Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted     patients.   "
115326|NCT01776320|"     A Phase 4 clinical trial that is open, with no blinding of subjects or randomization of     treatment. Patients with erectile problems will be given the approved drug Vitaros to treat     their condition. They will be given forms and questionnaires to complete. The information     collected will be used to assess the effectiveness, safety and the satisfaction levels with     this drug.   "
115329|NCT01776281|"     - Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of     deaths among premature and low birth weight LBW infants. Even if the infants are born in     facilities, incidences of cold stress are possible due to insufficient resources, space and     incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo     Mother Care is a well-known intervention to address the issues related to preterm births,     such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC     interventions for preterm infants, no interventional study has been found in literature in     Pakistani context. Looking at the potential benefits of KMC in reducing the related     complications of prematurity, the study aims to identify the effectiveness of KMC among     preterm and LBW infants born in secondary hospital of Aga khan University hospitals.      Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and     LBW infants as compared to the usual care.      Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome     among experimental and control group.      Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of     suspected infections during hospitalization.      Hypothesis II Ha: There is a difference in length of stay among experimental group and     control group.      Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four     weeks.      Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and     control after discharge from hospital.   "
115330|NCT01776268|"     Background:      Infection in preterm infants is a common, costly, and devastating problem frequently causing     death or sequelae for survivors. An immature immune system underlies the frequency and     severity of infections in this vulnerable population. The mouth is the site where microbes     first meet the mucosal immune system. Antimicrobial proteins and peptides (APPs) in saliva     kill microbes and improve immune cell function. Low APP levels increase the risk of     developing infection. Colostrum and human milk reduce the risk of infection. This protective     effect of human milk may come from supplying or stimulating infant production of APPs. No     prior investigation has determined the concentration of APPs in saliva or the effect of human     milk/formula on the APP concentrations in saliva.      Objective(s) and Hypothesis(es):      The investigators objectives are to identify and serially determine the concentrations of key     APPs in colostrum, human milk, and preterm infant saliva using highly-sensitive and specific     mass spectroscopy methods. The investigators study is designed to test the hypotheses that     (a) all saliva APPs increase over time, (b) APP concentrations are higher in colostrum as     compared to human milk, and (c) APPs are increased in saliva of infants that receive     colostrum orally compared to those that do not.      Potential Impact:      If increased saliva APP levels are associated with oral colostrum priming, this discovery     would advance understanding of the immune properties of human milk and identify oral APPs as     important immune elements and potential therapeutic targets in this vulnerable population.     This knowledge has the potential to alter feeding practices and provide a safe, low cost     means to improve immune function and significantly improve outcomes for preterm infants.   "
115331|NCT01776255|"     Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention     which addresses the growing problem of childhood obesity in American Indian communities. The     study works with six rural and urban American Indian communities across the US to test the     ability of the intervention to increase adoption of healthy lifestyles and to reduce the     prevalence of obesity among preschool aged American Indian children and their primary     caregivers - creating healthier children, healthier families and healthier communities. Our     primary hypothesis is that children and their primary caregivers who receive the HCSF-2     intervention will have better obesity related outcomes than those who do not receive HCSF-2.   "
115332|NCT01776242|"     The overall objective of BOLD is to establish a large, community-based registry (at least     5000 subjects) of patients aged 65 years and older presenting with new episodes of healthcare     visits for back pain. BOLD's primary aim is to create an infrastructure that allows for the     conduct of prospective, controlled studies comparing the effectiveness of diagnostic and     treatment strategies for back pain in older adults.   "
115333|NCT01776229|"     Untreated trauma-related nightmares and sleep-related disorders are associated with chronic     health problems, burdening both the suffering individual and the health-care system. The     study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed     children. It is the first randomized clinical trial with children, adapting an efficacious     adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a     mechanism in development and maintenance of secondary post-trauma psychopathology, medical     problems and family dysfunction. Therefore, this treatment may prevent long-term secondary     health and behavioral problems. It provides a viable healthcare option to Oklahomans,     lessening long-term financial medical and behavioral health expenses. Scientific models     currently view PTSD treatment as primary, often leaving nightmares untreated. That approach     does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold     PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy     can advance the field's understanding of the development of trauma sequelae.   "
115334|NCT01776216|"     Hypertension and endothelial dysfunction are being increasingly recognized as key etiological     factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). A     substantial body of evidence indicates that treating patients with elevated blood pressure     (BP) leads to marked reduction in the risk of stroke, myocardial infarction, heart failure,     and renal failure. There is also accumulating evidence associating endothelial dysfunction,     which is defined as incapacity of the arteries to vasodilate when required, to elevated BP     and an increased risk of CVD.      While there are more and more studies on how diet affects BP in healthy subjects, the impact     of dairy consumption per se on both endothelial function and ambulatory BP has not been well     characterized in patients with established essential hypertension. Therefore, the general     objective of the study is to investigate in a single-blind randomized controlled study the     impact of dairy consumption on ambulatory BP and endothelial function in subjects with mild     to moderate essential hypertension.   "
115335|NCT01776203|"     In this study, the investigators would like to see if giving medroxyprogesterone acetate for     3 weeks after Leuprolide acetate injection will help to decrease this amount of bleeding,     decrease the amount of nausea, bloating and cramping and increase patient satisfaction   "
115337|NCT01776177|"     The primary objective is to assess the clinical effectiveness of long-term omalizumab therapy     in 240 patients treated over an 8 year period in a real-life clinical setting and to compare     the pre- and post-treatment clinical characteristics to identify and better understand the     markers of response to omalizumab.      To date, there are no established criteria for identifying 'response' to omalizumab therapy.     Currently, the commonly accepted clinical criterion for omalizumab treatment response is the     physician's overall assessment, GETE (Global Evaluation of Treatment Effectiveness). Most     clinical trials have evaluated the efficacy of omalizumab treatment after a 16 week treatment     period and lack the impact of long-term omalizumab therapy.      Investigators propose multiple approach modules to better assess and identify 'response' and     to define 'responders' to omalizumab and evaluate the long-term impact in a real-world     clinical practice. Besides evaluating individual outcome variables, it is important to     attempt the 'clustering of variables' to further investigate if any baseline clinical     phenotypes are predictive of better response enabling us to refine the patient population who     will gain most benefit from therapy.   "
115338|NCT01776164|"     Friedreich's ataxia is characterized by progressive alterations in the function of the     cerebellum accompanied by an atrophy of the spinal cord. Although the genetic defect     responsible for the disease has been identified more than 15 years ago, objective markers of     the pathologic process (i.e., biomarkers) that would allow measuring the effects of potential     therapies are still lacking. Moreover, it is still unclear how the malfunction of the     cerebellum affects the rest of the brain, and understanding the connectivity and     neurochemistry of the central nervous system might yield new insights in the understanding of     the disease, in addition to providing potential markers.      To address these needs, the investigators aim at utilizing the capabilities of Magnetic     Resonance Imaging (MRI) and Spectroscopy (MRS). Using techniques called Diffusion Imaging,     resting-state functional MRI, and Proton Spectroscopy (1H MRS), the investigators propose to     determine the differences in the connectivity and neurochemistry of the spinal cord and the     brain between patients affected by Friedreich's ataxia and healthy controls. The     investigators plan on imaging both patients and control subjects using a 3T magnet, a system     that although not yet available in all medical facilities, is becoming standard in most     hospitals and clinics. The first aim is to scan patients already scanned last year (12-month     follow-up). The second aim is to scan patients at an early stage of the disease.   "
115339|NCT01776151|"     The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500     cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at     reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350     cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk     of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart     disease. In this study, the stiffness of arteries will be measured at study entry, months 4,     8, 12, and annually thereafter, using a tonometer on the participant's forearm.   "
115341|NCT01776125|"     Neurofibromatosis (NF) is a common genetic disorder that cause tumors to grow along various     types of nerves and, in addition, can affect the development of bones and skin. It occurs in     1:4000 persons. NF has been classified into three distinct types: NF1, NF2 and     Schwannomatosis. NF1 is the focus of this study.      NF1 is an extremely variable disorder which ranges from extremely mild cases in which the     only signs of the disorder in adulthood may be multiple café-au-lait spots and a few dermal     neurofibromas, to more severe cases like disfigurement, scoliosis and learning disabilities.     Scoliosis (abnormal curvature of the spine) is perhaps the most common bone deformity in NF1     which usually appears in early childhood. There are two types: dystrophic and non-dystrophic     scoliosis. Dystrophic scoliosis is usually associated with other bone deformities which are     seen on x-ray and carries a poorer prognosis than non dystrophic scoliosis. There is evidence     that genes other than the NF1 gene are responsible for the variable severity of cases. Recent     studies have identified genetic markers for another condition called adolescent idiopathic     scoliosis (scoliosis which presents in adolescent age group with no known cause). We believe     that the same genetic markers may also be present in NF1 patients with scoliosis.      Our objective is primarily to determine if the same genetic markers discovered in adolescent     idiopathic scoliosis are also present in NF1 patients with scoliosis.   "
115342|NCT01776112|"     To explore: (a) if physical exercise (sports) combined with cognitive training leads to     (superior) improvement of cognition in schizophrenia compared to sports or cognitive training     alone (b) if a sports program alone or in combination with cognitive training has influence     on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo     condition.   "
115343|NCT01776099|"     In animal models and retrospective studies, certain food components such as sugars and fiber     have been detected as potential agents to influence development and progress of type 2     diabetes.      The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble     ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in     patients with long-term type 2 diabetes and intensive insulin treatment.   "
115344|NCT01776086|"     The purpose of this studying is to develop and characterize neuropsychological testing     software for evaluating the prefrontal and temporal function of patients. As no software has     been used for this purpose, this study will gather pilot data on the baseline performance of     patients in a hospital setting that lack any neurological impairment. After creating this     baseline, later experiments can be proposed to compare the performance in normal subjects     with those who have neurologic injury or disease.   "
115345|NCT01776073|"     The purpose of this study is to measure the effect of introducing a patient navigator to     guide high and moderate risk patients through the pre-waitlisting phases of the kidney     transplant process. Patients identified as being at high and moderate risk of delay to     waitlisting will be linked with a patient navigator, who will facilitate their completion of     pre-waitlisting requirements. We believe that patients who are randomized to a patient     navigator will be more likely to complete the pre-waitlisting process and will complete the     process more quickly than high and moderate risk patients who do not receive additional     assistance from a patient navigator.   "
115346|NCT01776060|"     The goal of this study is to enroll 100 participants with Primary Progressive Multiple     Sclerosis (PPMS) that have joined the MURDOCK Study Horizon 1.5 (Duke IRB Pro00011196) and     the Multiple Sclerosis cohort (Duke IRB Pro00023791). All 100 participants will complete a     biannual collection of a follow up questionnaire and blood/urine collection for a period of 5     years.   "
115347|NCT01776047|"     Study Design : randomized, open label, single-dose, 2-way cross-over design      Phase : Phase I   "
115348|NCT01776034|"     The objective of this study is to conduct a randomized controlled pilot study to examine the     efficacy, feasibility and safety of the SystemCHANGE™ health promotion and wellness program     in stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ program     will help overweight and obese stroke survivors engaging in healthy behaviors, thereby     improving health and function.   "
115349|NCT01776021|"     The purpose of this study is to compare the effects of a cranberry juice beverage on rates of     Urinary tract infection (UTI) recurrence in women with a history of UTI.   "
115350|NCT01776008|"     This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or     without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and     goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells.     Giving MK-2206, anastrozole, and goserelin acetate together may kill more tumor cells.   "
115351|NCT01775995|"     Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It     is often refractory to treatment, with patients requiring long-term opioid therapy.     Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive     disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for     CLBP, it may produce additive benefits. The goal of this randomized controlled trial (RCT) is     to evaluate the feasibility and efficacy of an innovative behavioral intervention to improve     the health of adults with opioid-treated CLBP. This RCT will test the hypotheses that, at 26     weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in     a wait-list control group (usual care alone), will improve health-related quality of life     (primary outcomes: pain severity and physical function) and reduce opioid medication use     (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and     improve stress-sensitive measures and economic outcomes.   "
115360|NCT01775878|"     The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and     will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa     Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be     randomly assigned to one of two treatment arms. The telemedicine group or the group receiving     usual care (the control group).      This study hopes to show the usefulness of this telemonitoring technology and more     specifically, to assess whether this device improves markers of control of diabetes, glycemic     control, and cardiovascular risk factors   "
116136|NCT01764776|"     This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects     with impaired hepatic function and healthy subjects with normal hepatic function.   "
115352|NCT01775982|"     To validate the French version of the CAM, a multicenter diagnostic study will be conducted.     The principle of this study is identical to the study of Inouye which initially validated the     CAM in 1990. This is to verify the diagnostic properties of the CAM (French version) compared     to the gold standard represented by the confused state of psychiatric diagnosis using the     DSM.      A representative sample of geriatric patients for whom a delirium is suspected, will be     recruited in the various participating centers, patients will undergo two consecutive visits:        -  A visit by a geriatrician, during which the confused state of the patient will be          evaluated using the French version of the CAM.        -  A visit by a psychiatrist during which the diagnosis of confusional state will be          evaluated using the gold standard criteria of the DSM IV.      These two evaluations will be conducted on the same day and blinded from each other.      The order of these two procedures will be balanced within each center. This process will     allow the calculation of diagnostic parameters of the CAM French version (validation     competitive): sensitivity, specificity, positive and negative predictive values .   "
115353|NCT01775969|"     Outpatient antibiotics are frequently prescribed from the emergency department, and limited     health literacy may impact compliance with recommended treatments. The investigators are     looking to determine if patient preference for multimodality discharge instructions for     outpatient antibiotic therapy varies by health literacy level, and if modality effected     patient-reported antibiotic compliance and 72-hour antibiotic pick-up.   "
115354|NCT01775956|"     Septic shock remains the dominant cause of death in ICU's of the developed world with     approximately 400,000 cases annually in the US and another 20,000 annually in Canada. While     many retrospective and prospective reviews of septic shock patients have been undertaken     worldwide, many key questions remain unanswered. These questions include the true incidence,     associated morbidity and mortality of septic shock in North America, key factors associated     with successful management and markers suggesting a high probability of a complicated     clinical course. Part of the reason for the persistence of these questions, is the fact that     previous and ongoing reviews of septic shock and severe sepsis have been either limited in     number (typically <150) or biased by the need to be eligible for specific clinical trials     (typically, non-eligible patients have not been followed and had data collected.      We propose to examine specific questions within a temporally comprehensive cohort of septic     shock patients by review of individual charts using a defined data-extraction template.   "
115355|NCT01775943|"     Lung cancer is the leading cause of cancer-related death worldwide and is well known to     remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80%     of all the cases of lung cancer.      Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations     within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of     NSCLC patients.      Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for     L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR     TKI sensitivity.      Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered.     G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame     insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.      However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR     mutations are also observed. These rare mutations have not been fully described and data on     their correlation with response to EGFR-TKIs are still unclear.      Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients,     which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon     20, have some possibility of EGFR TKI sensitivity.      Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR     TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during     the short period.   "
115356|NCT01775930|"     The goal of this clinical research study is learn if carfilzomib can help control kidney     cancer. The safety of this drug will also be studied.      Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells     cannot repair themselves, this may cause them to die.   "
115357|NCT01775917|"     During the recent decades the need for surgical evacuation of the uterus in early     miscarriages and incomplete miscarriages has been questioned.      It has been shown that an observational approach can be, in many cases, as good as an     invasive one without increasing the incidence of uterine infections.      it has been shown that misoprostol - prostaglandin E1 given for missed abortions is     successful in emptying the uterus in 85% of cases without any need for surgical intervention.     and during recent years many women prefer this approach than the surgical one .      Many have tried using sonographic signs such as endometrial thickness, the presence of a     gestational sac, and color doppler to differ between blood clots and a gestational residua in     uterus, and to decide according to these signs wether there is a need for surgical evacuation     or an expectant management could be used. but none of these methods have been proven to be     completely efficient as predictors.      In this study the investigators will examine whether the doppler indices in the uterine     arteries can help to predict which gestational residua needs surgical evacuation of the     uterus and which could be managed expectantly.      The study hypothesis is that the resistance in uterine artery doppler will be lower in cases     with intrauterine residua as opposed to high resistance in cases without residua.   "
115358|NCT01775904|"     The purpose of this study is to evaluate two different formulations of LY2886721. In     addition, this study will determine how much of study drug (LY2886721) gets into the blood     steam and how long the body takes to get rid of it after taking each formulation with or     without a meal. Information about any side effects that may occur will also be collected.     Each participant may be involved in the study for approximately 7 weeks.      This study requires 4 periods. In each period, participants will receive LY2886721 as a     tablet or capsule, with or without food and water. There is a 7 day washout between each     period.   "
115359|NCT01775891|"     Investigators hypothesized that the use of Pilsicainide after radiofrequency ablation of AF     could reduce the incidence of recurrence of atrial arrhythmia during follow up compared with     other class IC antiarrhythmic drugs.   "
115383|NCT01775579|"     We investigate the potential pharmacokinetic drug-drug interaction between metformin extended     release and rosuvastatin in healthy male volunteers who receive metformin extended release     alone, rosuvastatin alone, and both together in a 3 period repeatedly.   "
115361|NCT01775865|"     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United     States with older age being a primary risk factor. The number of adults greater than age 65     years will almost double to 70 million by 2030, therefore identifying therapeutic strategies     for treating or preventing age-related disorders in humans is of major biomedical importance.     Cardiovascular aging, defined as a reduction in vascular and cardiac functions with normal     aging, occurs even in the absence of CVD risk factors and overt CVD. A key feature of     cardiovascular aging is stiffening of the large elastic central arteries such as the aorta     (the large blood vessel that leaves the heart and supplies blood to the body). This is     important because aortic stiffness directly contributes to clinical problems such as     increased blood pressure, reduced blood flow to the heart muscle, and thickening of the heart     muscle. Therefore, these clinical consequences are hypothesized to mediate a substantial     proportion of the increase in CVD risk in older adults. However, effective drug treatments     for aortic stiffness are not currently available and the biological reasons (mechanisms)     involved in causing aortic stiffening remain undefined. In addition, the inability of smaller     blood vessels to relax, impairment of the heart to relax during the filling phase of the     heart cycle (i.e., diastole), and increased blood pressure variability (fluctuations in blood     pressure through the day), have all been linked to aortic stiffness. Furthermore, chronic     low-grade inflammation with advancing age has been proposed to be a common mechanistic link     (i.e., biological reason) between these reductions in cardiovascular function in older     adults. Therefore, the investigators propose that inflammation could be a novel therapeutic     target to treat cardiovascular aging in older adults. Our central hypothesis is that     inflammation mediates the age-related deterioration in cardiovascular functions observed with     advancing age through the development of oxidative stress (i.e., imbalance between cellular     production of damaging oxygen free radicals vs. protective antioxidants). Our hypothesis     predicts that chronic inhibition of inflammation with Salsalate, an FDA-approved     anti-inflammatory drug similar to aspirin that is typically used to treat rheumatoid     arthritis pain and known to inhibit the 'master' regulator of inflammation in the cell (i.e.,     nuclear factor kappa B), will improve cardiovascular function in older adults. In addition,     the investigators hypothesize that the mechanism for the improvement in cardiovascular     function during inhibition of inflammation will be by suppressing oxidative stress. To test     our hypothesis, the investigators will randomize older healthy adults (age 50-79 years) to 3     g/day of salsalate or placebo (i.e., pill with inactive substance) pills for 4 weeks and have     cardiovascular function measured at baseline and again after 4 weeks.   "
115362|NCT01775852|"     The purpose of this research study is to examine whether a one-day group workshop,     integrating principles from Acceptance and Commitment Therapy with Migraine Education, will     result in improvements in depressive symptoms and functioning impairment in patients with     comorbid migraine and depression.   "
115363|NCT01775839|"     Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of     co-administered drugs   "
115364|NCT01775826|"     The majority of the US population spends most of the day sitting and the we have new     scientific evidence that this can contribute to poor health regardless of how much physical     activity a person does. However, we do not measure sitting time very accurately and when we     ask people to tell us how much they do, their answers are unreliable. Our study will use     small sensors to objectively measure when people sit or do physical activity, and we will use     sophisticated computational techniques to summarize these movement patterns.   "
115375|NCT01775683|"     Homeless men and women suffer more illness and sooner death compared to housed people. Among     the homeless, there is a group that suffers more illness than others. This group is usually     homeless for several months, makes up a smaller proportion of homeless people and uses more     resources from emergency shelters than other homeless people. Some have asked if a difference     in thinking skills explains how people who are homeless for a long time need more help in     getting and keeping housing compared to other homeless persons.      In this study, thinking skills that help a person plan and make decisions will be screened     among those who have been homeless for a long time and those who were homeless for a short     time. If there is a difference, then screening may change how future homeless people get the     help they need.   "
115376|NCT01775670|"     The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints     provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis.   "
115365|NCT01775813|"     The Health Influences of Puberty (HIP) Study is designed to explore the relationships between     puberty and the onset of type 2 diabetes in adolescents. The results of this study will help     us better understand how to prevent type 2 diabetes in these youth. Children go through many     changes during puberty, including important hormonal and behavioral alterations. Among these     changes, it has long been known that, during puberty, insulin does not work as well as it     does before and after puberty. This is called physiologic insulin resistance. In healthy     children, this does not cause diabetes or affect blood sugar in any way because the body is     able to compensate by making more insulin. Indeed, this is thought to be an important part of     the adolescent growth spurt. However, in some children with increased risk for developing     type 2 diabetes due to obesity and genetics, the worsening insulin resistance of puberty     cannot be compensated for and these youth get diabetes early. The investigators believe this     is because type 2 diabetes is rarely, if ever, seen before puberty begins, and the peak of     diabetes onset in adolescents occurs at the time of the worst insulin resistance. This     specific research project has two goals: 1. To examine effects of obesity on how well the     body's insulin works during puberty, and 2. To see if treatment of obese children during this     critical period of puberty with a medication that improves insulin resistance (metformin)     will help prevent early onset type 2 diabetes.   "
115366|NCT01775800|"     Many patients on hemodialysis experience high rates of symptom burden, such as pain,     depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by     modifying the usual guidelines used to manage patients on hemodialysis. For example, rather     than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have     treatment goals of less than 6.5, in order to reduce the number of pills they need to take     and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone     goals will also be modified, to see if these modifications help hemodialysis patients feel     better.   "
115367|NCT01775787|"     This study will examine whether nicotine levels increase with electronic cigarettes. It will     also examine whether electronic cigarettes alter lung function tests. The study will obtain     preliminary data on the medical effects of electronic cigarettes, with two different nicotine     flavors, tabacco and tabacco with menthol, which are available for over the counter purchase.      The elctronic cigarettes and juice used in this study is available for purchase through the     internet. An investigational new drug application (IND) is not needed for this study.   "
115368|NCT01775774|"     This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic     Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute     Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of     hMSCs in patients with ARDS.   "
115369|NCT01775761|"     The purpose of this study is to investigate the effects of tafamidis on the intervals of the     electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.   "
115384|NCT01775566|"     The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the     Eperisone HCl SR and Myonal in healthy Korean male adults.   "
115370|NCT01775748|"     The study will compare Concord grape juice to a beverage that contains no grape flavonoids,     but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese     participants over age 50 will be enrolled. Each participant will drink each beverage for 4     weeks with a 2-week rest period between two beverage consumption periods. The order of     beverages (grape juice first or placebo juice first) will be randomized. The investigators     will use ultrasound to measure brachial artery flow-mediated dilation, a measure of     endothelial vasodilator function. The investigators will also collect blood samples to     further assess the cardiovascular effects of grape juice.      The aim of the study is to determine whether Concord grape juice improves endothelial     function in patients at risk who do not have cardiovascular disease and may provide     information that would guide dietary recommendations. The results may also be used by the     sponsor to substantiate claims and labeling of their product.   "
115371|NCT01775735|"     The primary objective of this study is to evaluate the safety and efficacy of occipital nerve     stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the     management of intractable chronic migraine, when used in conjunction with anti-migraine     medications.   "
115372|NCT01775722|"     Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin.     However, even though the pulsed dye laser is considered as the treatment of choice for Port     wine stain Birthmark the degree of fading can remain variable and unpredictable after laser     treatment.   "
115373|NCT01775709|"     Otitis media is the most common illness in children and 5% to 10% of their symptom cause by     fluids in their middle ear . The OME can cause hearing loss included poor development of     speech and poor communication.      The surgical procedure is considered simple and relatively safe, but several complications     may occur after Pressure Equalizing tube insertion. The most prevalent complications are     otorrhea, biofilm and formation of retraction pockets. Otorrhea occurs in 30% to 83% of     children with tube and is mainly due bacterial contamination of the middle ear either from     external ear canal or impaired Eustachian tube. Swimming can facilitate the entry of bacteria     into the middle ear from the ear canal through the PE tubes, and this assumption is     reinforced by the statistically significant association between the rate of otorrhea and the     non-utilization of ear plugs in children who swim (from 47% in children who used ear plugs to     56% in those who did not).   "
115374|NCT01775696|"     The main objective of this study is to investigate the central and peripheral inflammatory,     as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early     stages of AD by combining molecular imaging techniques with blood biomarker analyses. The     early and preclinical stages of AD will be studied in the relatives of patients with PSEN1,     PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will     evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD     progression. Inclusion of sporadic and familial forms of AD will aid in studying the     chronology of pathological events. Clinical follow-ups will be conducted annually for two     years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear     in the early stages of the disease and to constitute new prognostic factors. I2ARs could also     become therapeutic markers for the assessment of novel anti-amyloid treatments and may offer     new insights to the development of Aβ-specific immunotherapy strategies.   "
121446|NCT01696266|"     This study is conducted in Europe. The aim of the study is to gather information about     hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The     study is both retrospective and prospective.   "
115377|NCT01775657|"     This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on     the duration of pleural drainage after lung resection in patients with and without a     pulmonary air leak on postoperative day 1.      Patients undergoing pulmonary resection who fit the inclusion criteria will be identified     pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to     receive either the analogue system or the digital system. Both systems are approved for use     in hospitals by Health Canada. There will be 88 patients in each air leak group.      Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an     improvement in primary outcomes.   "
115379|NCT01775631|"     The purpose of the study is to determine the safety, tolerability and maximum tolerated dose     of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma   "
115380|NCT01775618|"     Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form     blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting     process to be slowed and the person experiences bleeds causing serious problems that could     lead to disability. The current standard treatment for severe hemophilia A is infusion of     FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. Due     to the short half-life of FVIII, prophylaxis may require treatment as often as every other     day.      In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being     evaluated in 50 male subjects, < 12 years of age, with severe Hemophilia A. These subjects     will receive open label treatment with long-acting rFVIII for approximately 6 months (or     longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and     dose intervals may be adapted to the subject's clinical need. A second group of patients will     receive open label treatment with the same drug for 12 weeks on a regular schedule of     2x/week. Patients will attend the treatment center for routine blood samples and will be     required to keep an electronic diary.      Subjects will be offered participation in an optional extension study to collect observations     for at least an additional 50 exposure days.   "
115381|NCT01775605|"     Local infiltration with lidocaine prior to epidural placement for cesarean section, although     brief, can be painful. This pain can lead to increased anxiety and distress, adversely     affecting patient's overall experience. This study proposes to examine the application of     Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.      The primary objective of this study is to determine the effect of the Synera on maternal     experience during epidural placement. The efficacy of Synera pain patch in reducing subject     pain during skin infiltration with lidocaine prior to epidural placement in subjects     presenting for scheduled cesarean section will be assessed.   "
115395|NCT01775423|"     This is an open label, single arm, dose escalation study of BBI608 in patients with advanced     malignancies.   "
115385|NCT01775553|"     The purpose of this study is to determine the safety and activity of the investigational drug     known as carfilzomib in the treatment of multiple myeloma (MM) when it is given at doses     above the usual dose after the standard dosing has become ineffective. The other purpose of     this study is to understand what causes the multiple myeloma to become resistant to     carfilzomib and whether this can be overcome in the laboratory.   "
115386|NCT01775540|"     This study was to evaluate the healing action on the eye surface of the artificial tear     Systane® ULTRA as compared to two other eyedrops: Maxidex and Saline solution. Dry eye     disease leads to inflammation of the eye surface and treating dry eyes with artificial tears     may lead to reduction in this inflammation and improvement of symptoms and signs.   "
115387|NCT01775527|"     IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it     represents an important cause of end-stage kidney failure. This disease was described as a     distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain     still obscure. Clinical observations and immunisation studies indicate that IgAN represents a     dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years     ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the     disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The     unusual characteristics featured by the IgA produced by these cells (charge, size,     glycosylation) drive their accumulation, deposition and mesangial activation characteristic     of IgAN.      Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant     localization.   "
115388|NCT01775514|"     This non-interventional study will assess the occurrence rate of non-small cell lung cancer,     colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey, and the     diagnostic methods and treatments used. Data will be collected over 36 months.   "
115433|NCT01774929|"     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so     the drug will enter the body through the skin) in participants with moderate (medium level of     seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder,     which is seen mostly in older persons, in which the joints become painful and stiff).   "
115537|NCT01773564|"     Intravascular devices in intensive care units are often associated to complications. The     investigators estimate that 23.5% of catheters placed and used in intensive care are subject     to at least one complication; the investigators goal is to demonstrate the effectiveness of     the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of     complications associated with intravascular catheters in intensive care.   "
115389|NCT01775501|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational combination of drugs to learn whether the drug     combination works in treating a specific cancer. Investigational means that the modified     FOLFOX and sorafenib combination is still being studied and that research doctors are trying     find out more about it-such as the safest dose to use, the side effects it may cause, and if     the combination is effective for treating different types of cancer. It also means that the     FDA has not yet approved the modified FOLFOX and sorafenib combination that will be used in     this study for liver cancer.      FOLFOX is a combination of three drugs: folinic acid (leucovorin), fluorouracil (5-FU), and     oxaliplatin. The dosage amounts for some of these FDA approved drugs will be modified     slightly in this study. The FOLFOX combination is approved by the FDA and is a standard     treatment of colorectal cancer. However, it is not approved for the treatment of liver     cancer.      Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of     liver cancer. It is also currently being tested in various other cancers. Sorafenib works by     slowing down and/or stopping the development of new cancer cells and new blood vessels. By     slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed     that sorafenib prevents or slows down the growth of tumors.      In this research study, sorafenib, the standard treatment, is being combined with modified     FOLFOX, which has shown some antitumor activity in liver cancer.   "
115390|NCT01775488|"     The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy     device. The purpose of this study is to assess and monitor the performance of the Vortx Rx     for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.   "
115391|NCT01775475|"     This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral     chemotherapy works in treating patients with previously untreated stage III-IV human     immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy,     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone,     lomustine, etoposide, and procarbazine hydrochloride, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug (combination chemotherapy) may kill more cancer cells   "
115392|NCT01775462|"     This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male     newborns in the first two weeks of life. All subjects will meet entry criteria including     documentation of an Ectodysplasin (EDA) mutation associated with XLHED. Following Baseline     evaluations, EDI200 dosing will be initiated between day-of-life 2 and 14, with each study     subject receiving 2 doses/week for a total of 5 doses. The study will enroll subjects in two     cohorts with subjects in cohort 1 dosed at 3 mg/kg/dose, associated with partial efficacy,     and cohort 2 dosed at 10 mg/kg/dose where enhanced efficacy was demonstrated in the most     relevant preclinical model. Given the challenge of identifying families where the subject is     yet to be born, it is expected that cohort size and time for recruitment will be variable.   "
115393|NCT01775449|"     Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal     cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by     acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy     appearing with the repetition of chemotherapy cycles.      To this date there is no effective therapy able to prevent and/or to treat these adverse drug     reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop     chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute     oxaliplatin-induced hypersensitivity in animals.      So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may     prevent acute oxaliplatin-induced hypersensitivity in patients.   "
115396|NCT01775410|"     This is a prospective, multi-center, non-randomized single arm feasibility trial of the     Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed     with peripheral vascular disease of the lower extremities.The primary disease must be located     in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to     severe symptoms and warrant vascular intervention.   "
115397|NCT01775397|"     The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical     cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive     therapy.   "
115398|NCT01775384|"     Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the     Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green     tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced     physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both     traditional and metabolomics-based outcome measures.   "
115469|NCT01774461|"     The aim of this study is to investigate the effect of remote ischemic preconditioning on     biochemical and functional indices of cardiac function induced by a 30 km run in healthy     trained long distance runners.   "
115399|NCT01775371|"     Background: Inadequate pain management is common in the Emergency Department (ED). Optimal     treatment of pain necessitates titration to effective dose due to the large inter-individual     variability in opioid requirement. However nurse administered titration is difficult to     provide in this setting due to high patient to nurse and physician ratios and multiple urgent     competing patient demands. Patient controlled analgesia (PCA) lets ED patients actively     participate in pain management by allowing self-titration to their desired level of pain     relief. A tightly controlled randomized clinical trial (RCT) funded by NINR recently     completed by the investigators group provides promising preliminary support for the efficacy     and safety of PCA for patients with abdominal pain at a single ED with a dedicated research     nurse and standard loading dose given to all patients. Objective: The overall objective is to     provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness and     safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the     intervention to a broad group of ED patients with acute pain at multiple clinical centers.     The primary hypothesis is that there will be a greater decline in pain over time and similar     safety in patients randomized to receive PCA compared to patients receiving standard opioid     analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance,     resource utilization and cost associated with PCA. Innovation: PCA represents a novel shift     from the current provider-driven model of ED pain management to one in which the patient is     an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation     of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers.     750 patients with acute pain warranting IV opioid administration will be randomized to     receive usual opioid analgesia determined by the provider or PCA (loading dose 0.1 mg/kg     morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be     measured by a numerical rating scale recorded every half hour up to 2 hours after initial     opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes     after initial administration of opioid to 2 hours as suggested by the results of the     preliminary study and incidence of adverse events. PCA will also be compared to non-PCA     opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with     pain management; RN assessment of time efficiency/ease of use and satisfaction with pain     management; and physician satisfaction with pain management. Resource utilization and cost     associated with implementation and use of PCA in the ED setting will be assessed by total RN     time spent on pain management per patient; pharmacy preparation time per patient; material     cost per patient and RN and MD training time necessary for PCA implementation. Significance:     If PCA is demonstrated to be effective, safe, and associated with patient and provider     acceptance and acceptable resource utilization, it has the potential to significantly improve     ED pain management.   "
115400|NCT01775358|"     The primary objective of this study is to evaluate the safety and tolerability of a single     dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.   "
115401|NCT01775345|"     To determine that rehabilitation treatment for a partial meniscectomy is more efficient in     the functional recovery of the knee. Set in the fewest possible sessions, what treatment has     benefits that last beyond the physical and what is the best cost-effectiveness.      It is expected that the combination of isotonic and isokinetic exercises in post-meniscectomy     physiotherapy allows faster and less costly patient rehabilitate than the current isotonic     protocol.   "
115402|NCT01775332|"     The purpose of this research study is to determine the utility of educational materials     designed to inform patients of their pituitary condition, in an effort to assist the     patients, families, and staff deal with pituitary tumours and related conditions in the best     way possible. We have developed a website, informational videos, and a brochure for pituitary     tumour patients and their families. The primary outcome measures will be 1) the level of     knowledge that patients have of their condition before and after reviewing the materials     provided; and 2) ease of use and user satisfaction of the materials. We hypothesize that our     informative multimedia educational package will not only improve the health literacy and     self-efficacy of patients and their families, but will also improve quality of care.   "
115403|NCT01775319|"     Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable     isotope absorption studies in women of childbearing age consuming test meals prepared from     either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two     different extraction rates.      Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat:     stable isotope absorption studies in women of childbearing age, or men, consuming test meals     prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or     post-harvest fortified wheat extrinsically labeled immediately before consumption.   "
115404|NCT01775306|"     The aim of this study is to find out if data can be provided by external sensor technology     which is suitable for controlling the therapy of patients with cardiac recompensation.   "
115405|NCT01775293|"     The aim of this study is to evaluate the efficacy and safety of the investigational device,     RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.      Study hypothesis        -  level of significance: alpha=0.05( two-side)        -  power of test: (power= 1-beta),power=0.08        -  H0: P equals P0        -  H1: P unequals P0        -  The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre          and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)   "
115406|NCT01775280|"     The study enrolls patients with non-resectable or borderline resectable hepatocellular     carcinoma (HCC), intraheaptic choalngiocarcinoma (IHCC) or colorectal cancer metastasis.     Patients are not a candidates for liver transplantation and have only limited extrahepatic     disease. All patients are treated with radioembolization. Primary endpoint is the percentage     of patients that can be downstaged to resectability.      Secondary endpoints are radiologic response to radioembolization,tissue response to     radiomembolization and systemic immune response and intra-tumoral T-cell response to     radioembolization.        -  Trial with radiotherapy   "
115474|NCT01774396|"     Assessment of efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with     Emervel® Touch and Emervel® Deep Lidocaine combined or not with Emervel® Touch in female     patients with loss of fatty tissue in hands.   "
115475|NCT01774383|"     The ERD and ERS patterns of coordination between the STN and cortical regions in the     termination of volitional movement in PD patients.   "
115407|NCT01775267|"     This randomized phase II trial compares how well associating liver partition with portal vein     ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating     patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing     liver cancer. ALPPS may be more effective than PVO in patients whose disease would     traditionally be considered inoperable.        -  Trial with surgical intervention   "
115408|NCT01775254|"     The overall purpose of this study is to describe the trajectory of early survivorship in     individuals with colon cancer who undergo both surgical and medical management of colon     cancer. The primary question is whether or not there is an interaction between type of     surgery and changes in quality of life, sexual function, peripheral neuropathy, and demands     of illness following curative resection and adjuvant chemotherapy.   "
115409|NCT01775241|"     It is the objective of this study to collect scientific data of sleep apnoea syndrome     patients´ cardiac and respiratory function by additional sensors.   "
115505|NCT01773993|"     To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related     to their appropriate use in daily practice.   "
115506|NCT01773980|"     The goal of this project is to develop and pilot test an innovative approach for overcoming     barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon.     Many studies have shown that people with disabilities receive fewer indicated cancer     screening services and are more likely to have poor cancer-related outcomes, such as late     stage at diagnosis, compared to those without disabilities.   "
115410|NCT01775228|"     Recovery from coronary artery bypass graft (CABG) surgery is a complex process involving     physical recuperation and psychological adjustment. The high prevalence of postoperative     depression in this population may threaten optimal recovery. Peer support over the recovery     period has promise to mitigate this threat. The purpose of this study was to examine the     effect of a professionally-guided telephone peer support intervention on recovery outcomes     including depression, social support and health care resource utilization.      In a randomized controlled trial, 185 male CABG surgery patients randomly assigned to an     intervention (n=61) or usual care (n=124) group. Participants in the intervention group     received weekly telephone calls from a peer volunteer over 6 weeks post discharge. At     hospital discharge and at 6 and 12 weeks follow up, depression was measured using the Beck     Depression Scale-II, social support was measured using the Shortened Social Support Scale and     health care resource utilization was measured using items in the Postoperative Self Report of     Recovery Questionnaire. Participants in the intervention group were also asked questions     about their perceptions regarding peer support using the Peer Support Evaluation Inventory.   "
115411|NCT01775215|"     In patients with aortic stenosis the valve through which blood is pumped out of the main     heart chamber is narrowed. This results in heart muscle working harder to open the valve so     blood can circulate around the body. The muscle adapts to the increased pressure load to     maintain efficiency. This can cause long-term muscle damage. To predict when this     deterioration will require a valve replacement is difficult and untimely operation exposes     patients to unnecessary risk.      We aim to compare all validated techniques looking at different aspects of heart muscle     strain in these patients. These will be a blood sample measuring a specific hormone (BNP) and     enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying scarring and     an exercise echocardiogram that measures heart muscle response and pressure changes across     the valve. Tests will be performed at recruitment and either after one year or after valve     replacement, which ever comes first.      In comparing these different imaging techniques we aim to identify patients who will benefit     from an early operation, those whose muscle is likely to recover back to normal and which     patients it is safe to wait longer for the surgery, avoiding unnecessary risk.      The results of the study will benefit patients as it will help doctors more accurately assess     the timing of valve surgery and improve their prediction of long term heart muscle recovery.     It may also increase convenience in clinical management by reducing unnecessary tests and     hospital trips. This would translate into cost savings for the NHS.   "
115412|NCT01775202|"     This descriptive study aims to evalaute in a retrospective way the incidence of cogntive     changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is     based on chart reviews.   "
115413|NCT01775189|"     The main purpose of this study is to determine if oxycodone and naltrexone combination     capsules (ALO-02) have the potential to be abused when they are crushed and snorted.   "
115414|NCT01775176|"     The purpose of the study is to test in 52 overweight and obese women with polycystic ovary     syndrome the effect of 6 months of treatment with either: exercise training, 25% dietary     restriction or metformin in comparison to a control group receiving no intervention on the     functions of the skeletal muscle and adipose tissue.   "
115415|NCT01775163|"     The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and     spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study.     We aim to determine if changes in energy metabolism might explain why people don't lose the     expected amount of weight in an exercise program.   "
115416|NCT01775150|"     We plan to integrate WHO educational material using mobile phone text messaging, target on     pregnant women in remote rural areas in China. We hypothsized that text messaging can have     major impact on reducing maternal and infant deaths in rural China because text messaging is     accessible, acceptable, and affordable.   "
115417|NCT01775137|"     The purpose of this extension study is to collect additional 48 weeks of safety data from     patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting     second year safety data through this study is to obtain long-term (2 years) safety data of     TIP.   "
115418|NCT01775124|"     The study will evaluate the efficacy and safety of two different dosing regimens of     ranibizumab (either monthly injections or injections as-needed based on the stability of a     patient's vision) in Chinese patients with wet AMD . This study is to provide long-term     safety data in the treatment of Chinese patients with wet AMD.   "
115476|NCT01774370|"     This is a prospective, non-interventional, open-label, multi-centre study. It will provide     additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical     settings.   "
122601|NCT01681212|"     The purpose of this study is to determine the survival rate after 1 year of treatment with     ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or     Stage IV melanoma.   "
115419|NCT01775111|"     The aim of this randomized, observer-blind, controlled intervention study with parallel     groups is to study the effect of strength training (2x/week for 6 months) with and without     additional dietary supplementation (protein-enriched) on muscle strength, function and mass,     oxidative stress parameters and the immune system in elderly institutionalized persons.      The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener     Pensionistenwohnheime). After a pre-participation screening participants will be distributed     randomly but stratified by sex and age to one of the 3 intervention groups (cognitive     training, strength training, strength training + supplement).      Study participants are eligible if they are male or female with an age over 65 years and if     their cognitive status as well as their physical fitness level allows to participate at the     strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate     the medical training therapy, serious cardiovascular disease, diabetic retinopathy and     manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular     strength training during the last six months.      Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary     outcome measures comprise anthropometric data, functional performance tests, immunological     and oxidative stress parameters. The change in muscle signaling pathways will be assessed     from muscle biopsies.   "
115420|NCT01775098|"     The objectives of the present study are to determine if starting treatement of hyperuricemia     with allopurinol during an acute gout crises has an impact on the duration or the severity of     the crises   "
115507|NCT01773967|"     The investigators will study the efficacy and side effect profile of LGG, a probiotic, in     pediatric patients with acute gastroenteritis.   "
115508|NCT01773954|"     To evaluate the visual outcome and number of injections required during an optical coherence     tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment     of subfoveal neovascular age-related macular degeneration (NVAMD).   "
115421|NCT01775085|"     The purpose of this study is to compare two types of groups for breast cancer survivors: a     Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to deal     with the emotional burden of having gone through the cancer experience. Participation in     groups offering support often helps cancer survivors cope with stressors of life after having     had cancer by giving them a place to express their feelings. The Meaning-Centered Group is     intended to teach breast cancer survivors how to maintain or even increase a sense of meaning     and purpose in their lives after treatment for cancer. The Discussion Group is intended to     help breast cancer survivors cope by giving them a place to get support from other breast     cancer survivors.      The goal of this study is to compare the benefits of these two types of group approaches for     breast cancer survivors. The study is also testing the benefits and feasibility of conducting     the groups virtually using a telephone and computer.   "
115422|NCT01775072|"     The purpose of this study is to determine whether certain genes in cancer may be abnormal.     When a gene is abnormal this is called a mutation. Most mutations in cancer cells are not     inherited (passed down from parents) but happen after birth in the cancer itself. Most     cancers have many mutations. Some of these mutations are important for the cancer cells to     survive while others are not. The goal of this study is test cancer for certain mutations     using leftover tumor tissue from a previous surgery or biopsy. Participants will also be     asked to provide a tube of blood cheek (also known as a buccal) swab, or a saliva sample that     contains normal genes for comparison.      The purpose of Part B of this study is to:      Understand how genetic changes in tumor effect the chance of responding to experimental     cancer treatment. Understand how the genes in the tumor change overtime in response to     targeted cancer treatment.   "
115423|NCT01775059|"     This is a multi-center, non-randomized, and interventional study in which subjects will use     the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm®     VEO™ insulin pump (Sensor augmented pump) for 15 days.      The purpose of this study is to collect performance data on the Integrated sensor and     infusion set for approximately 15 days, with the intention for each subject to wear 5 sets     for 3 days each.   "
115424|NCT01775046|"     The objective of this study is to assess the benefits of endovascular technique in terms of     efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the     treatment of thoracic aortic disease, in a cohort of patients representative of the     population treated under real-life conditions of use in France for up to 5 years.   "
115425|NCT01775033|"     The overall goal of this project is to develop and evaluate an organized, regional system of     pediatric emergency care in rural western Pennsylvania.   "
115426|NCT01775020|"     Pilot data in patients and data from pig studies indicate that arginine-NO metabolism is     impaired in sepsis with changes in splanchnic metabolism and function, and reduced survival     at low nitrate levels. Prolonged intravenous supplementation of L-arginine proved effective     in pigs for increasing NO production, restoring gut function, and inhibiting an increase in     pulmonary arterial pressure, without any deleterious systemic side effects. Prolonged     intravenous L-arginine supplementation could therefore be useful in septic ICU patients.   "
115427|NCT01775007|"     A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the     viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis     is that the instrument can measure the Brillouin light scattering spectra from the eye safely     and effectively from human subjects.   "
115428|NCT01774994|"     Investigation of arginine and NO metabolism in healthy subjects is important as a reference     for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the     changes during aging and gender-related differences. Although data on arginine metabolism     exist in literature, data are limited to young healthy male subjects. Since patients with     suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly     and also women, knowledge of arginine metabolism in these groups is needed.   "
115429|NCT01774981|"     The purpose of this two-part study is to investigate the safety, tolerability and efficacy of     LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy     (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate     Proteinuria.   "
115430|NCT01774968|"     The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin     three times a day versus twice a day.   "
115431|NCT01774955|"     This is a multicenter, prospective, observational investigation, focusing of antiplatelet     treatment in patients with moderate to high risk acute coronary syndrome (TIMI risk score     ≥3)subjected to percutaneous coronary intervention (PCI), being conducted in 7 PCI capable     hospitals in Greece. Data concerning patients' demographic, clinical/procedural     characteristics and contraindications/special warnings and precautions to P2Y12 inhibitors     are collected during initial hospitalization. Study involves 3 follow-up visits after     hospital discharge(Day 30, at 6 months and at 12 months) where data on major adverse cardiac     events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or     CABG), bleeding events(according to Bleeding Academic Research Consortium criteria)and     adherence to antiplatelet treatment are collected.      In patients under ticagrelor or prasugrel treatment, platelet reactivity measurement with     VerifyNow assay will be performed at Day 30   "
115432|NCT01774942|"     Gum disease and type 2 diabetes are common chronic diseases that affect each other. Diabetes     is increasing, especially in Pakistan. People with diabetes have a greater risk for gum     disease. Also, it is thought that that gum disease, a chronic infection, can be a source of     systemic inflammation and may contribute to poorer diabetes control.      The aims of this project are to study:        1. Changes in sugar control in people with type 2 diabetes and severe gum disease after          having all teeth removed and replaced with Straumann dental implants and full dentures        2. Changes in certain inflammation markers seen with insulin resistance and other diseases          and conditions more common in people with diabetes        3. Retention of dental implants in people with type 2 diabetes.      The study will recruit 30 patients with type 2 diabetes and severe gum disease from Dr. Amin     Rahman's private practices in Pakistan. Their long-term sugar (HbA1c) must be 7.5% or more     and the inflammatory marker, C-reactive protein (hsCRP) 1mg/dL or more. Consenting     participants will first have an oral examination. Eligible patients will have impressions of     the jaws and the color of their teeth and gums recorded. At the next visit, all teeth will be     extracted and dentures provided. One week later, there will be a check-up visit. Three months     after the teeth were removed, Straumann dental implants will be placed in the jaws. After one     week, the patient will be checked again. After three months, the dentures will be adjusted to     fit the implants. Follow-up visits will occur every three months until one year after the     implants were placed, then every six months for the next five years, to check the health of     the patients as well as their implants, the gums around them, and the dentures. Blood samples     will be taken at each follow-up visit.      Our hypotheses are that levels of HbA1c and hsCRP will:        1. decrease after extraction of all teeth        2. not increase after placement of dental implants        3. not increase after prosthetic restoration with full dentures anchored on the dental          implants.   "
115434|NCT01774916|"     Cutaneous Arteriovenous malformations (AVM's) rare congenital high-flow vascular     malformations in which arteries and veins are directly connected through a complex web of     abnormal arteries and veins instead of a normal capillary network. Arterial feeders and     enlarged draining veins directly connect through arteriovenous fistulas that create the     nidus. The natural history of AVMs is organized into a clinical staging system: during the     first phase of quiescence, the arteriovenous malformation mimics a capillary malformation.     After many years, the AVM may enlarge with loco-regional expansion and tissular destruction.     At the ultimate stage, AVM may impact the heart function. They are considered non malignant     but can expand and become a significant clinical risk when extensive. The management of these     high flow AVM remains often problematic. Complete and large surgical excision of the nidus     after hyperselective embolization is the only potential therapeutic solution but this, is     often difficult if not impossible. There is no pathogenetic hypothesis for the development of     these malformations. Histopathological examination (performed only on surgical resection     specimen) is poor and does not provide sufficient evidence to assess the evolutivity or the     severity of the MAV. Recent data hypothesize that these vascular malformations are associated     with alterations of the vascular endothelium caused by genetic abnormalities involved in the     control of angiogenesis and vascular homeostasis. The detection of these anomalies allows the     search for cellular and genetic markers that might be useful to optimize the clinical     classification, staging, predicting the evolution of these defects and some understanding of     its pathophysiological mechanisms. To our knowledge, no studies to identify cellular markers     / genetic and endothelial associated with the development of cutaneous AVMs have been     published to date.   "
115435|NCT01774903|"     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so     the drug will enter the body through the skin) in severe (very serious, life threatening)     chronic (lasting a long time) low back pain in Thai participants.   "
115436|NCT01774890|"     The remarkable improvement in survival of children with congenital disease has led to a     continuously growing number of adults with congenital heart disease in the developed world.     Many of these patients had had cardiac surgery at early age, the may live for many years with     pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any     combination of the above. These past and ongoing cardiac insults often result in significant     cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and     prognostic value for these patients.      Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of     biomarkers are used. In the last decade, our group has focused on the natriuretic peptides as     markers for heart disease in infants and children. This resulted in many studies and more     than 25 publications in the medical literature. We believe that the newly discovered cardiac     marker, ST2, will emerge as an important addition to cardiac evaluation in the coming     years.The aim of this study is to measure ST2 levels in patients with congenital right heart     disease and correlate ST2 levels to clinical status, imaging and prognosis.   "
115437|NCT01774877|"     Bi Syndrome is one of Traditional Chinese Medicine（TCM）name, It means an obstruction in     Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the     meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as     soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic     disease affecting more than 20 million people in the world.It is one of the most common forms     of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which     originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory ,and     it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed to     evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.   "
115438|NCT01774864|"     Study Design : multi-center, double-blind, placebo-controlled, randomized,      parallel group, fixed dose design      Phase : Phase III   "
115439|NCT01774851|"     To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more     effective than paclitaxel and trastuzumab alone   "
115440|NCT01774838|"     To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute     coronary syndrome endothelial function -as a surrogate parameter of NO bioavailability- and     different markers of inflammation, oxidative stress and platelet activation will be assessed     in patients with unstable angina.   "
115441|NCT01774825|"     After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching     placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms   "
115477|NCT01774357|"     This is an observational registry study aiming to collect data on efficacy and safety of the     single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up     period is 24 months. All analyses on the data will be done post-hoc; the study does not     intend to confirm any pre-specified hypotheses.   "
115442|NCT01774812|"     Despite advances in treatment of conventional cardiovascular risk factors, patients with     kidney disease remain at high risk for fatal cardiac events. To date, kidney disease affects     approximately 2 million Canadians; however, this patient population remains grossly     understudied due to the complex nature of the disease. The inadequacy of the literature to     address the cardiovascular-related mortality rates in those with kidney disease reflects the     urgent need for investigation of novel risk factors.      One cardiovascular risk factor which has recently been validated is the clinical measurement     of cardiac autonomic tone (CAT). CAT refers to the amount of activity contributed by the     stimulatory and inhibitory limbs of the cardiac autonomic nervous system, which work in     concert with one another to control heart rate. CAT can be quantified computer analysis of     heart rate over time, captured by a simple Holter electrocardiogram (ECG) recording. Abnormal     CAT, which occurs when the autonomic system does not control heart rate properly in response     to physical demands or stress, is associated with risk of adverse cardiovascular events in     both healthy and high risk populations. It has recently been shown that patients with severe     kidney disease demonstrate significant CAT abnormalities, thus exaggerated susceptibility to     cardiac death.      Vitamin D (VD) deficiency is also common in this patient population due to the fact that the     kidney plays a crucial role in VD metabolism. Given that VD deficiency is an established     cardiovascular risk factor on its own, it is possible that kidney disease patients     experienced compounded risk due to the combination of VD deficiency and abnormal CAT.     However, no study has ever investigated whether VD deficiency influences CAT in healthy or     diseased populations. To our knowledge, this will be the first trial to ever examine the     effect, if any, of different VD supplementation treatments (standard of care vs. combination)     on CAT in a population burdened with overwhelming risk and incidence of cardiovascular and     sudden cardiac death risk.   "
115443|NCT01774799|"     This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among     360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10     intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly (up     to 12-months) regarding goals of care preferences, advance care planning, and treatments     received. The primary outcome is decisions not to be hospitalized at 6 months.   "
115509|NCT01773928|"     The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza     vaccine produced by the modified manufacturing process:        1. induces immune responses comparable to that produced by the current manufacturing          process        2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza          vaccine        3. demonstrates consistency of immune response among three different lots.   "
115932|NCT01768403|"     Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of     this study is to establish the proportion of patients on lipid-lowering pharmacological     treatment reaching the LDL-C goals according to the Third Joint European Task Force     guidelines in the survey population.   "
115444|NCT01774786|"     This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm     study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab,     fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive     metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be     randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks     (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg]     intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine     (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue     to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of     unacceptable toxicity or withdrawal from the study for another reason.   "
115445|NCT01774773|"     E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a     single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases     including pre-randomization (before drug administration) and postrandomization (after drug     administration).   "
115446|NCT01774760|"     The results of previous studies suggest further development of [18F]EF5 as a PET tracer for     imaging hypoxia. This is a non-randomized prospective study to obtain information on     reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.   "
115447|NCT01774747|"     Double-blind, placebo-controlled, multiple ascending oral dose evaluation of the safety,     tolerability, and pharmacokinetics of DSP 1053 and its metabolites in healthy subjects and in     subjects with major depressive disorder   "
115448|NCT01774734|"     1. Chronic neck pain is common in general population.             -  High health care source expenditure             -  Multiple therapeutic approaches available with limited evidence             -  Previous studies showed active strengthening exercise improved pain (VAS) and               functional performance (NDI)             -  Muscle strengthening exercise with biofeedback technique showed more long-lasting               effect in patients with chronic neck pain        2. The investigators hypothesize that daily use of the neck strength exerciser (NSE),          combined biofeedback technique with muscle strengthening exercise posture adjustment, in          addition to traditional physiotherapy, could have more long-lasting and prominent effect          on pain and functional improvement in patients with chronic neck pain.   "
115449|NCT01774721|"     This is a multinational, multicenter, randomized, open-labeled, Phase 3 study comparing the     efficacy and safety of treatment with Dacomitinib (PF-00299804) to treatment with gefitinib     in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal     growth factor receptor (EGFR) activating mutation (s). Analyses of primary objective     (Progression Free Survival) will be done as defined in the protocol.   "
115450|NCT01774708|"     Presence/absence in bed along with heartbeat, respiration, and gross motion in bed will be     measured in 48 Budd Terrace residents, a long-term care facility of Emory Healthcare.     Measurement will be done using only pressure-sensitive mats that lie underneath the mattress     and never touch the patient. PHI information will be collected by Emory staff. This PHI will     be restricted to: age at time of participation; medical conditions; and medications. The PHI     will be stored in a locked file behind a locked door. Data management will provide a unique     identifier for each participant linked to a name that will be kept separately from the     aggregate data.      The data collected from the bed sensor will be processed offline and separately from the PHI     to do proof of concept evaluation for the use of machine learning technology to predict bed     exits 1 to 5 minutes ahead of time.   "
115451|NCT01774695|"     Increased physical activity has in the investigators recent study been shown to improve     symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long term     effects of the investigators previous intervention in IBS patients to improve physical     activity. The investigators aimed to assess the long term effects on IBS symptoms as well as     quality of life, fatigue, depression and anxiety.   "
115452|NCT01774682|"     The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional     parameters of patients perambulation.   "
115453|NCT01774669|"     The patient study is a phase III trial designed as a single-blinded, randomised, controlled     multi-centre trial with repeated measurement events (ME). Patients will be evaluated by a     blinded assessor on five occasions: twice within two weeks at baseline before intervention     start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2),     and once after a two month follow-up period (FU). Figure 1 illustrates the study overview.      The study focuses on the evaluation of the YouGrabber efficacy compared to conventional     therapy in an outpatient setting.      Research question: Do patients after stroke in the YouGrabber training group show higher     postintervention performance in the Box and Block Test (BBT) compared to patients in the     conventional therapy group? Hypothesis: H0: The investigators hypothesise that there will be     no group differences after 16 training sessions or after the two month follow-up period.      H1: The investigators hypothesise that there will be a group difference after the 16 training     sessions and after the two month follow-up period.      Aim: The aim of the project is to design and implement a single-blinded, randomised     controlled multi-centre trial comparing YouGrabber training and conventional therapy in     patients after stroke.      Patients will be randomly allocated to either the experimental group (EG) or the control     group (CG) after the second ME (T0). Group allocation will be based on a computer-generated     randomisation list (one for each centre, (MATLAB, 2007b, Mathworks Inc., USA) created by a     researcher not involved into the study. Randomisation lists and corresponding token will be     stored in the clinics' pharmacy. Patients will draw a token before the first therapy session.     The token will be marked and stored until study finalisation in the pharmacy.      Group allocation will remain concealed for the independent assessor until study finalisation.     Patients and treating therapists will be reminded not to talk about patient's group     allocation with other therapists or participants.      Patients in both study groups (EG, CG) will receive the same amount of 16 sessions lasting     for 45 minutes each. During each therapy appointment patients can decide to stop the training     at any time.      Patients allocated to EG will have the opportunity to participate in two semi-structured     interviews to evaluate their expectations and experiences with the virtual reality therapy     with YouGrabber.      Treating therapists will have the opportunity to participate in one focus group meeting to     evaluate their experiences with the virtual reality training, its advantages and     disadvantages. Interview and focus group participation will be voluntary.   "
115454|NCT01774656|"     The purpose of this study is to determine the proportion of subjects who have sufficient     improvement in ventricular function after undergoing a standardized Left Ventricular Assist     Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of     the LVAD within 18 months.   "
115455|NCT01774643|"     This is a feasibility study to perform image-guided liver biopsies in 25 patients who have     pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the     liver). This will contribute with samples for the bio-bank (bank of tumors) and develop     xenografts (human tumors growing in mice) for further analysis of genes.   "
115538|NCT01773551|"     The purpose of this research study is to investigate whether breast density measured by a     safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can     detect the decrease of breast density in subjects who receive tamoxifen when compared to     patients who do not receive any drug. If decreased density can be reliably detected, it may     help determine which subjects will benefit by taking tamoxifen or other chemoprevention     drugs.   "
115456|NCT01774630|"     Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal     translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth     and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor     (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing     durable responses. However, requiring continuing IM indefinitely and the ability of IM to     eradicate the CML clone was uncertain.      In a small proportion of patients, IM can induce complete molecular response (CMR) defined by     the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question     whether or not these patients are cured and can discontinue drug therapy has been assessed by     Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in     patient with a CMR of at least 2 year duration and all patients who relapsed after IM     discontinuation mainly did it in the first 6 months and responded to reintroduction of     imatinib.      Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved     target specificity over imatinib. Its efficacy and safety in the treatment of patients who     are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led     to the registration in second and first line treatment of CML-CP patients. Nilotinib produces     even faster and deeper responses with more occurrence of CMR than does Imatinib.     Consequently, one can assume that a more potent drug such nilotinib could induce deeper and     sustained CMR allowing longer period off treatment than IM.      The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in     molecular relapse after IM discontinuation and to provide an estimation about duration of CMR     after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of     stable CMR with nilotinib.   "
115457|NCT01774617|"     It is a cohort to evaluate the power of different diagnostic tests in predicting the     prognosis of patients with severe liver disease.      Patients with decompensated liver cirrhosis on the waiting list for liver transplantation     will be evaluated with comparison of different diagnostic tests according to the MELD score     (Model for End-Stage Liver Disease), MELD-Na (Model for End-Stage Liver Disease and sodium),     indocyanine green clearance test, hepatic venous pressure gradient and transient     elastography. All patients will be submitted to all the tests and prospectively followed for     6 months, to establish mortality and complications related to liver disease in order to     define the value of each method to predict outcomes.   "
115458|NCT01774604|"     The purpose of this study is to assess whether peri-procedural administration of rectal     indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.   "
115459|NCT01774591|"     The purpose of the research is to evaluate the effect of azilsartan medoximil on blood     pressure and urinary aldosterone levels in postmenopausal females.   "
115460|NCT01774578|"     The purpose of this study is to assess overall survival of anti-tumor immunization using     HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed     non-small cell lung cancer (NSCLC) that have been previously treated.   "
115461|NCT01774565|"     The main study objective is to compare conventional insulin therapy with automated     closed-loop glucose control in achieving target glucose levels in hospitalised     insulin-treated T2D subjects over 72 hours (phase 1) and inpatient hyperglycaemia requiring     subcutaneous insulin therapy up to 15 days (phase 2).      This is an open-label, two-arm, randomised, parallel design study in hospitalised     insulin-treated T2D subjects (phase 1) and inpatient hyperglycaemia requiring subcutaneous     insulin therapy (phase 2), during which target glucose levels will be controlled either by     closed-loop system combined with (phase 1 only) once daily basal insulin injection or by     conventional insulin therapy in random order.   "
115462|NCT01774552|"     Port-wine stain is a congenital, progressive vascular malformation of human skin involving     post-capillary venules that occurs in an estimated 0.3% of children and can alter personality     development and psychological in children.   "
115463|NCT01774539|"     Children who suffer fractures to the growth plates (physes) of their bones are at risk for     premature growth arrest which can lead to long term complications. There is currently no     technique to predict who is at risk of growth arrest following a physeal injury. The     investigators aim to determine if diffusion MRI (an imaging method to analyze tissue     properties) can effectively pick up differences between a healthy growth plate and an injured     one. This would allow orthopaedics surgeons to predict which injuries are at a higher risk of     growth arrest, so earlier interventions can be done in the orthopaedic clinic.   "
130464|NCT01577329|"     The purpose of this study is to assess the feasibility and potential impact of an eight week     program of meditation on expiratory time, anxiety and dyspnea in people with COPD.   "
115464|NCT01774526|"     Lung Cancer continues to be the major cause of cancer-related mortality in Singapore.     Non-small cell lung cancer (NSCLC) accounts for 75% of lung cancers and adenocarcinoma is the     most common histological subtype. Although cigarette-smoking is the main cause of lung     cancer, more than a third afflicted in Singapore are never-smokers and 69% affect females.     For the majority who present with advanced NSCLC, chemotherapy is the mainstay of treatment.     Despite advances made with newer chemotherapeutic agents, it is apparent that the benefit of     conventional chemotherapy has plateaued. Efforts toward developing novel treatments based on     growing understanding of molecular oncology have yielded drugs that target vascular     endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR). They have     expanded treatment options for patients with advanced NSCLC. However, monoclonal antibody to     VEGF is contraindicated in patients with squamous cell carcinoma due to increased incidence     of fatal hemoptysis. EGFR tyrosine kinase inhibitors (EGFR-TKI) appear promising but only 40%     of east-asian female never-smokers with lung adenocarcinoma harbour EGFR gene mutations.     Estrogen, KRAS, BRAF, ERBE and other genetic mutations can confound response. Molecular data     obtained from Caucasian and predominantly east-asian population may not apply to our     multi-ethnic groups and our aim is to determine the molecular characteristics of our     multi-ethnic asian phenotypes to better understand the process of carcinogenesis and     treatment response as well as identify potential novel targets for future drug development.     Paraffin-embedded tissues are recalled, and DNA is extracted for mutational analysis, which     will be correlated to patient demographics, treatment and outcome.   "
115465|NCT01774513|"     The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle     with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis   "
115466|NCT01774500|"     We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal     ranges can rule out seizure recurrences and severe outcome, and allow early discharge from     the emergency department   "
115467|NCT01774487|"     The purpose of this study is to determine whether pentoxifylline reduces liver damage in     infants with biliary atresia.   "
115468|NCT01774474|"     Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the     last few years, several new treatments have been tried to address the problem of CME after     cataract surgery in diabetic and non-diabetic patients. The investigators will perform a     large RCT with the aim to provide more definite evidence-based recommendations for clinical     guidelines to prevent the occurrence of CME after cataract surgery in patients with and     without diabetes mellitus (DM).   "
115470|NCT01774448|"     People with dementia forget things and have trouble concentrating. In addition, they and     their caregivers can become depressed. This project will show whether Mindfulness-Based     Cognitive Therapy (MBCT) can lessen depression, increase attention spans and improve quality     of life for those affected by the disease and their caregivers.      MBCT combines intensive training in mindfulness meditation with Cognitive Behavioural     Therapy. Studies show the meditation component creates changes in areas of the brain     associated with our ability to pay attention. This form of meditation can help those impacted     by dementia become more aware of their depressive thinking, leading to improved ways of     coping.      The investigators predict that individuals in the early stages of dementia and their spousal     caregivers will report fewer depression symptoms following the 8-week Mindfulness-Based     Cognitive Therapy (MBCT) Program, as well as experience improvements in quality of life and     daily mindfulness.      If successful, MBCT could improve the quality of life in individuals with dementia and their     caregivers, as well as may take pressure off the health care system by delaying     institutionalization.   "
115471|NCT01774435|"     This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation     durations of 6 months.   "
115472|NCT01774422|"     The patients affected by severe chronic respiratory failure can develop hypercapnic     decompensation leading to coma and death in a few hours. At present, the main treatment is     noninvasive or invasive ventilation. The noninvasive invasive ventilation requires a minimum     of consciousness to insure spontaneous ventilation. In case of noninvasive ventilation     impossibility, invasive mechanical ventilation is proposed to patients, which is an     aggressive therapy. Regularly, the patients undergo this aggressive therapy without having     expressed their opinion. Indeed, a great majority of these patients with severe respiratory     insufficiency did not anticipate directives in case of respiratory decompensation     (acceptation of aggressive treatments). Efficiency of these aggressive therapies is still     uncertain but certainly alters quality of life (discomfort, loss of autonomy…). After     complete, clear, loyal and adapted information, a majority of patient do not wish to go on     these aggressive therapies. At the time of the decompensation, the patients are incapable to     express an opinion because of the hypercapnic narcosis. An extracorporeal CO2 remover device,     such as the DECAP CO2, would quickly decrease the hypercapnia what would allow the patient to     improve his state of consciousness and so to find the conditions of spontaneous ventilation     required for the noninvasive ventilation. The DECAP CO2 device can be used to stop quickly     the hypercapnic narcosis and to collect the wills of the patient on the choice of possible     aggressive therapies. It is in this last condition that we wish to estimate the DECAP CO2     device.   "
115473|NCT01774409|"     It is a non-randomized, multicentric, cohort study, combined with a biological sample     collection, a retrospective clinical data collection and with a genetic and immunologic     biomarkers study.      The ProfiLER program aims to implement a personalized cancer medicine approach by proposing     to establish the genetic and immunologic profile of the tumor for patients with an advanced     malignant tumor, in order to define a map of genetic (for the pre-identified target genes)     and immunologic profiles for all the studied types of cancer. This study will also allow     adapting the therapeutic management of these patients, if needed, by giving them targeted     therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the     recommendations of the multidisciplinary molecular board.      The genetic and immunologic profile of the tumor will be determined from archival or fresh     collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The     correlation between genetic profiles of the tumor, patients immunity status and retrospective     clinical data (progression, tumor response, etc.) collected from the patient medical records     will probably allow us to identify biomarkers with a potential predictive value and to     determine if some genetic disorders are linked to immunity status alterations.   "
115478|NCT01774344|"     This clinical study evaluates the efficacy and safety of regorafenib in patients with     advanced liver cancer who have progressed on sorafenib treatment.      Approximately 560 patients who meet the entry criteria will be randomly assigned in a 2:1     ratio to regorafenib or placebo (1/3 chance to receive placebo).      Primary endpoint of the study is overall survival.   "
115479|NCT01774331|"     Primary:      • Demonstrate the utility of a new electronic data capture (EDC) system (CareExchange™) using     infusion nurse measured physical, quality of life (QOL), respiratory, and disability     assessments.      Secondary:        -  Change in Intravenous Immunoglobulin (IVIg) dose effects measured outcomes.        -  Change in IVIg dose and timing effects measured outcomes.        -  Change in patient status is reflected in measured outcomes.        -  Assess the value to physicians from infusion nurse collected outcomes data.        -  Identify types of patients by response to IVIg therapy (i.e. natural or poor          responders).        -  Change in response rate to IVIg therapy by disease state and demographics.   "
115510|NCT01773915|"     Alzheimer's disease (AD) is the most common neurodegenerative disorder afflicting the     elderly. Currently, some biochemical tests performed on Cerebrospinal Fluid (CSF) samples     have demonstrated to discriminate to some extend between AD and non-AD individuals based on     the levels of tau, phospho-tau or Aβ42. We aim to investigate newly identified proteins whose     levels increase during the Braak Stages of AD that are accessible in other body fluids such     as blood, urine or saliva. The detection of these proteins would allow performing simple     tests in case its levels were confirmed to be associated with the AD pathology.   "
115480|NCT01774318|"     Due to the development of neonatal intensive care the number of surviving premature infants     increased significantly. The immature brain undergoes a fair amount of external stimuli,     which have a great impact on later cognitive development. Increasingly data show, that a     delayed emergence of sleep-wake-cycling in newborns can be the first sign of brain injury.     Studies have shown that clearly defined sleep states can be identified from 31-32 weeks of     gestation onwards. But a few studies show, that also extremely premature infants already show     cyclical variations of the background pattern within amplitude-integrated EEG (aEEG= a     time-compressed, simplified EEG) and conventional EEG. This might resemble early     sleep-wake-states and their presence correlates to the integrity of the central nervous     system, although no clearly defined sleep states according to the classical definition can     be identified. Complex EEG analysis needs the use of automated methods to exclude personal     bias and to ensure gestational age specific data analysis. The newly developed NLEO algorithm     was specially designed for EEG analysis of premature infants. Conventional EEG within this     study will be analyzed visually and with the automated algorithm. In our research project we     will study the emergence of Sleep-wake-cycling in extremely premature infants and its impact     on their neurodevelopmental outcome prospectively. The different sleep and wake states will     be derived from analysis of the conventional Video-EEG, aEEG and polysomnographic     measurements. Visual analysis will include assessment of amplitudes and frequencies as well     as the latencies and durations of EEG-Bursts and Interburst intervals. The automated     NLEO-algorithm will be firstly used for comparison with above described visual analysis and     secondly to find regions of interest involved in the organization of these early sleep     states. The aim of this study is first to understand and analyze in detail the emergence of     sleep-wake cycling including its disturbances in premature infants and to compare automated     NLEO algorithm to conventional visual analysis methods. Secondly to correlate     neurodevelopmental outcome to the emergence of sleep-wake-cycling.   "
115481|NCT01774305|"     Coughing during emergence from general anaesthesia may lead to dangerous effects including     laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of     patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor     agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during     emergence from anaesthesia.      In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of     surgery reduces coughing during extubation after thyroidectomy.   "
115482|NCT01774292|"     The purpose of the study is to determined whether the administration of alkalized 4%     lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of     coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous     oxide as an anesthetic agent.   "
115483|NCT01774279|"     Anaplastic thyroid cancer has historically proven very difficult to research due to a     combination of its rarity and the associated short survival period for those affected. In     2009, 2340 patients in the UK were diagnosed with thyroid cancer with 70-90 expected to be     the anaplastic subtype 1,2. For these patients average life expectancy is in the range of 2-6     months with only a very small number surviving for more than one year. It is a highly     aggressive form of cancer that is refractory to current treatment options. By collecting     tissue and blood samples along with clinical data across the UK we will be able to accumulate     numerically significant numbers of samples and data points which will facilitate research     opportunities. Researchers will be encouraged to apply for access to the collected samples in     order to try and establish the causal mechanisms for disease development, potential     therapeutic targets and to relate clinical course and outcome with specific molecular     defects. Due to the rarity it is not feasible for a single cancer centre or cancer network to     accumulate sufficient samples for research in a meaningful timeframe hence the need for     national collaboration in order to try and offer patients with this disease hope in the     future.      All UK patients with anaplastic thyroid cancer would be potentially eligible. The project is     expected to run for at least 5 years and all thyroid cancer clinicians will be encouraged to     participate. Patients will be asked to donate surplus thyroid cancer tissue following routine     biopsy procedures along with an optional blood sample.      2. Objectives      Primary Objectives The primary objective of this project is to establish a national     anaplastic thyroid cancer tissue collection to help facilitate both basic and translational     research opportunities.      There is no direct research question that the project itself addresses at this stage. The     research proposals that subsequently arise as a result of this project will be generated by     accredited research parties from the UK and potentially internationally. These research     proposals will be submitted to the National Anaplastic Thyroid Cancer Tissue Bank and     Database Project (NATT) Steering Committee for assessment. As the volume of material     collected per patient is expected to be of small volume, by virtue of the specimen comprising     core biopsy or fine needle aspirate material, research proposals will need to be prioritised     according to the potential benefits the proposed research offers. Priority will be given to     projects that may lead to the identification of potential therapeutic targets. Each research     proposal will require their own ethical approval and research and development assessments     before commencing.      The steering committee will be multidisciplinary and will include nationally respected     researchers and thyroid cancer clinicians.      Scientific Justification The long term objective is to try and address the current lack of     understanding about the aetiology and progression of this disease and ultimately to develop     new therapeutic interventions that may slow the rate of disease progression, improve quality     of life and prolong what is currently a very short survival.      Due to the short prognosis following diagnosis it is notoriously difficult to run     interventional therapeutic clinical trials in this patient population. Patients usually     present with locally advanced and metastatic disease and as a consequence are often of poor     performance status making clinical trial participation very problematic. If potential     therapeutic targets could be identified in vivo it would potentially open up new therapeutic     avenues whilst sparing some patients with the 'wrong' molecular profile futile treatment.      This is a unique project within the setting of anaplastic thyroid cancer research.   "
115484|NCT01774266|"     In this proposal the investigators aim to develop a commercial kit to be used in primary     screening and non-invasive triage for early detection of gastric cancer. This kit will be     cost-effective and more accessible to the general population. In addition, the investigators     would like to expand our current patent already submitted to INAPI (National Institute for     Intellectual Property) and propose royalties to biomedical diagnostic companies for the use     of our product at international level.   "
115485|NCT01774253|"     The purpose of this research study is to evaluate an investigational drug (Vismodegib) for     Pontine Glioma that is growing or has come back (reoccurred). This study will look at the     tumors response to the study drug, Vismodegib, and will also look at the safety and     tolerability of Vismodegib.      Vismodegib has been tested in multiple adult clinical trials and one pediatric trial.     Laboratory testing in pontine gliomas suggests that this drug may be effective in treating     this disease.   "
115486|NCT01774240|"     Delirium is a common yet under diagnosed condition in hospitalized patients, and the     incidence have not previously been described in Danish cardiac surgery patients. The present     study seeks to describe the incidence and duration of delirium in this group of patients,     before and after the introduction of standardized screening tool and a guideline for     treatment of delirium after cardiac surgery.   "
115487|NCT01774227|"     -  Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma          management and is very easy to learn and easy to perform.        -  Recent advances in laser technology; the role of TSCPC is being expanded because it has          benefits of noninvasive glaucoma procedure.        -  The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation)          are three energy delivery techniques.        -  The present study would report on the outcome (efficacy and safety) of the          slow-coagulation versus the titration method in treatment of refractory glaucoma with          dark iris.        -  The results would provide reliable evidences to supplement clinical judgment when making          a decision in favor of each treatment method for glaucoma patients.   "
115488|NCT01774214|"     The purpose of this study is to determine which of two commonly used methods of manual     pediatric fluid resuscitation (The Push-Pull Technique vs. the Disconnect-Reconnect     Technique) allows for the most rapid administration of normal saline when this is urgently     required.   "
115575|NCT01773057|"     The purpose of this study is to determine whether the computerized decision support system     'NHGDoc' is effective in improving quality of primary care in terms of processes of care     (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital     admissions, mortality).   "
130655|NCT01575041|"     To determine the effect of (1) increased sodium intake and (2) increased potassium intake on     blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.   "
115489|NCT01774201|"     Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory     dysfunction due to weakness in the respiratory musculature has been described in MS. This     leads to increased morbidity and mortality in late stages of the disease. It is possible that     respiratory dysfunction influence physical fitness in earlier stages as well. Walking     disability and fatigue causes significant impact on health in patients with MS, even in     earlier stages.      The hypothesis is that there is a relationship between respiratory function, walking capacity     and fatigue and that daily deep breathing exercise during two months will improve respiratory     function, walking capacity and fatigue.   "
115490|NCT01774188|"     EECP therapy may affect the intraocular pressure while improving the ischemia systemic organ     blood perfusion the same time. The present study investigated the impact of Enhanced     Extracorporeal Counterpulsation treatment on the intraocular pressure.   "
115491|NCT01774175|"     The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about     bowel preparation, patient's satisfaction, side effects to identify effectiveness of new     bowel preparation drug.   "
115511|NCT01773902|"     Although expressed breast milk is considered the optimal nutritional source for preterm     infants, the macronutrient content is insufficient to enable optimal growth during neonatal     intensive care. Optimal dose and optimal mode of administration (standardized or     individualized) of enteral protein supplementation to very preterm infants have not been     established.      This study aims to compare the effects on weight gain of different modes of enteral protein     supplementation.   "
115512|NCT01773889|"     This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin     diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells     (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial     ovarian cancers, enhancing treatment efficacy.   "
115492|NCT01774162|"     Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many     gastrointestinal conditions, including but not limited to, malignant and pre-malignant     neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the     gastrointestinal tract. EUS is the most sensitive test for the detection of focal lesions     within the pancreas and is the most accurate method for diagnosing pancreas cancer. A biopsy     method for tissue sampling via EUS called fine needle aspiration (FNA) was developed that     enables a small needle to be passed into the lesion of interest under ultrasound guidance,     obtaining cellular material for cytology. EUS-FNA is currently recommended for the diagnosis     of cystic and solid mass lesions within and adjacent to the gastrointestinal tract. Yet in     certain clinical circumstances, it is more desirable and sometimes necessary to obtain a core     tissue biopsy for histology rather than the cellular material for cytology obtained with     EUS-FNA. Furthermore, histology may generally increase the diagnostic yield of EUS-FNA     compared to cytology. It is with these aims in mind that a new type of needle, the fine     needle biopsy (EUS-FNB) device was developed to enable core tissue sampling. Since a     comparison of these to methods has yet to be made, the aim of this study is to perform a     direct comparison of the sampling adequacy and diagnostic yield of the new EUS-FNB needle     with the conventional EUS-FNA needle.   "
115493|NCT01774149|"     Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers a     large amount of data on their disease. The study intends to see if giving advanced feedback     on these data can improve their blood glucose management.   "
115494|NCT01774136|"     This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a     Community-Integrated Management of Childhood Illness (C-IMCI) training for community     caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal,     newborn and child health interventions within households in rural communities in Ugu     District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two     components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and     supervisors, and (2) continuous support and supervision following the continuous quality     improvement (CQI) framework, a low-technology approach to management and supervision of     health programs. The primary objectives of the proposed evaluation are to measure the effect     of the intervention on key outcomes, including early uptake of antenatal care, facility based     delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR     testing in infants at 6 weeks. We will also examine the effects of the intervention on     immunization uptake up to 12 months and knowledge and practices of CCGs and mothers     pertaining to maternal, newborn and child health.   "
115495|NCT01774123|"     To evaluate the ability of different spectral domain optical coherence tomography (OCT)     devices, as well as different acquisition and analysis packages, to detect disease     progression in patients with multiple sclerosis with and without a history of optic neuritis   "
115496|NCT01774110|"     A. Specific Aims:      1. There is one specific aim of this study. The aim is to evaluate the effectiveness of early     standardized task-specific training (ESTT) in persons with acute stroke.      B. Hypothesis:      1. It is our hypothesis that subjects who receive ESTT will walk faster and more     symmetrically than published reports of gait outcomes in persons with stroke.   "
115497|NCT01774097|"     The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells     taken from a patient's bone marrow can be placed safely, via intramuscular injections, into     their affected calf and lower thigh muscles and improve blood flow and/or peak walking time     in patients experiencing pain associated with blocked blood vessels in the leg.   "
115498|NCT01774084|"     The purpose of this study is to determine whether preload of carbohydrate or water before     elective hip replacement improve insulin sensitivity and or beta cell function in human.   "
115499|NCT01774071|"     The purpose of this study is to see if a new diagnostic research agent named     89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long     89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an     antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached     to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by a     PET scanner. The results of this study may help researchers know whether 89Zr-DFO-MSTP2109A     can be used as a diagnostic agent for finding prostate cancer that have STEAP1 on its surface     with a PET scanner. The reason why identifying STEAP1 on prostate cancer cells is that new     therapies are being developed to target STEAP1 prostate cancer cells.   "
115500|NCT01774058|"     A prospective case-control study was performed to investigate the effect of iloprost on the     intraoperative flow volume in diabetic and non-diabetic patients as well as the effect of     peripheral neuropathy in patients with peripheral arterial occlusive disease (PAOD)     undergoing arterial reconstruction (primary endpoint).      100 patients undergoing femoral artery reconstruction or femorodistal bypass surgery were     included. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow     volume at the common femoral artery was assessed using a Doppler flowmeter (Sono TT FlowLab;     ) before reconstruction, prior to the intraarterial application of 3000ng of iloprost and 5     and 10 minutes afterwards. Peripheral resistance units (PRU) were calculated as a function of     mean systemic arterial pressure (MAP) and flow volume (VF): PRU = MAP (mmHg) / VF (ml/min).   "
115501|NCT01774045|"     The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject,     find the effective adequate dose for the next stage of the study, and accumulate information     of possible mechanism of its anti-depressive effect.   "
115502|NCT01774032|"     The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic     influenza vaccine in a Japanese elderly population aged 65 years and older.   "
115503|NCT01774019|"     The purpose of this study is to demonstrate that preoperative biliary drainage using     self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in     patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary     cancer.   "
115504|NCT01774006|"     Prospective randomized comparison of two widely used in vitro culture system in human IVF     treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media     droplets using conventional petridish or in group culture using WOW (well of the well)     petridish.      Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and     embryo quality   "
115514|NCT01773863|"     Community-acquired pneumonia is the most common infection leading to hospitalization in     intensive care units and the most common cause of death associated with infection disease.      Epidemiological studies have shown that respiratory tract infections are associated with an     increased risk for the development of acute cardiovascular and cerebrovascular events.      This link is further supported by studies indicating that influenza vaccination is associated     with a reduced risk of hospitalization for pneumonia as well as heart disease and     cerebrovascular disease.      Data connecting acute respiratory tract infections and cardiovascular events stem almost     exclusively from cross-sectional or retrospective studies. Thus the real incidence and the     prognostic impact of AMI, as well as the pathophysiological relationship between pneumonia     and cardiovascular damage is still elusive.      Inflammation plays a major role in the pathogenesis of coronary artery disease. The increased     concentrations of proinflammatory cytokines together with the activation of coagulation, the     down-regulation of anticoagulant mechanisms and the enhanced platelet aggregation may trigger     atheroma's instability, plaque rupture and thrombus formation.      Inflammation and coagulopathy are also considered universal host responses to infection in     patients with severe sepsis. Thus far limited data are available on the changes in these high     regulated systems, together with platelet activity in patients with CAP and their potential     relationship with cardiovascular risk.      This project will consist in a prospective multicenter study to investigate the incidence of     major adverse cardiac and cerebrovascular events (MACCE) in hospitalized patients with CAP,     its prognostic relevance and the potential relationship between enhanced cardiovascular risk     and the activation of inflammation, coagulation and platelet aggregation in this setting.   "
115515|NCT01773850|"     The goal of the study is to compare the radiologist confidence level in evaluating patients     with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis     imaging device. The comparison will be made against conventional mammography acquired as a     part of a standard clinical workup. One hundred patients who are to have a clinical surgical     breast biopsy will be recruited for the study. A reader study will be performed to evaluate     the ROC characteristics of the system.   "
115516|NCT01773837|"     Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional     capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central     nervous system stimulant that has traditionally been used in cancer patients to manage     depression, opioid‐induced sedation, hypoactive delirium due to multiorgan failure, and     cognitive disorder associated with brain tumors. Although there is evidence from prospective     studies of the efficacy of this drug in cancer‐related fatigue, the only one randomised     clinical trials gave non-conclusive results. In order to define the real efficacy of     methylphenidate in this setting, the investigators designed a new clinical trial comparing     methylphenidate and placebo in cancer‐related fatigue, assessed both by the verbal numeric     scale (VNS) included in the Edmonton Symptom Assessment System (ESAS) and the subscale for     fatigue of the Functional Assessment of Cancer Therapy (FACT‐F). The investigators will     include 122 advanced cancer patients with fatigue ≥ 5/10 (VNS, from 0 to 10) and hemoglobin ≥     9 g/dl. Patients will be randomized to methylphenidate or placebo. Doses will be adapted to     response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day. Assessment of     response will be performed on day 3 and day 6 with ESAS and FACT‐F. Drug‐induced adverse     events will be checked. The VNS of fatigue on day 6 will be consider the primary endpoint.   "
115517|NCT01773824|"     To evaluate the effect of a continuous postal and web-based feedback and peer comparison     system of individual antibiotic prescription rates on the prescription behaviour of primary     care physicians in Switzerland.   "
115518|NCT01773811|"     The current study proposes to directly measure how processing after participating in written     disclosure about a traumatic life event affects physical and psychological outcomes.   "
115519|NCT01773798|"     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic     (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the     trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with     type 1 diabetes.   "
115520|NCT01773785|"     The primary purpose of this study is to determine the effectiveness of SPI-1620 in     combination with docetaxel in patients with advanced biliary cancer.   "
115521|NCT01773772|"     The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH)     and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the     investigators aim to discover whether or not giving 2 small doses of progesterone to early     pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the     information gathered in this study, the investigators may be able to learn more about how     menstrual cycles are normally established in girls during puberty. Ultimately, if these     normal processes can be understood, the investigators may be able to better understand     abnormalities of puberty.   "
115792|NCT01770223|"     This study is being done to find out if participants with insulin resistance and hepatitis C     virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa     (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV     (triple therapy).   "
115522|NCT01773759|"     Ensuring that all children are fully immunized against vaccine-preventable diseases is a     critical public health issue. Child care programs are critical targets for efforts to     increase the proportion of infants and young children who are fully immunized. The primary     objective of this proposal is to rigorously examine current state, local government, and     child care providers' efforts and barriers to ensuring that all enrolled children are     up-to-date for required immunizations and to evaluate strategies to improve immunization     coverage in child care programs.   "
115523|NCT01773746|"     The most appropriate initial oxygen concentration for the resuscitation of the extremely low     birth weight infant has not been established using large well designed, randomized, blinded,     prospective trials and the level of oxygen utilized by practitioners in this situation is     highly variable. This proposed trial will use targeted oxygen saturation levels over the     first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the     resuscitation of such infants, and will be large enough to evaluate short term outcomes of     survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the     long term outcome of survival without significant neurodevelopmental impairment at 2 years of     age. Such information is urgently required to provide an evidence basis for the initial     oxygen concentration for resuscitation of these very preterm infants.   "
115524|NCT01773733|"     The aim of this study is to summarize the data on efficacy and safety of Reduxine     administration in the routine clinical practice according to the approved indications.   "
115525|NCT01773720|"     The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring     based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass     grafting.   "
115536|NCT01773577|"     Goal: To evaluate the effects of Interoperable Health IT on provider work flow and work     practices in the ambulatory care setting.      Interoperable health IT can produce a reduction of barriers in the exchange of health     information that can allow for more efficient, timely, and a higher quality of patient care.     This study seeks to evaluate the effects of the implementation of interoperable health IT on     the work flow of medical providers in the care environments in which they are implemented.   "
115526|NCT01773707|"     The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial.      All subjects will receive close monitoring for development of AGT or T1DM. Subjects will     receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess     the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM.      The primary objective is to determine whether intervention with Abatacept will prevent or     delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of     patients with T1DM.      Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of     C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic     outcomes.   "
115527|NCT01773694|"     Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is     likely to decrease the risk of infection and bleeding. However, this has never been formally     studied. Patient's routines are likely disrupted when they are asked to avoid wetting the     area. The investigators will perform a controlled study to determine if avoidance of     post-operative wetting is necessary.   "
115528|NCT01773681|"     The purpose of this study is to use magnetic resonance imaging (MRI) and high-resolution     peripheral quantitative computed tomography (HR-pQCT) techniques to look at the damage and     disease activity progression in the hand and wrist joints of patients with rheumatoid     arthritis.      The central hypothesis is that ongoing erosions and cartilage loss in rheumatoid arthritis     are due to persistent inflammation, which is poorly detected by clinical examination and     markers of systemic inflammation.   "
115529|NCT01773668|"     The purpose of this study is to collect performance data on the Integrated sensor and     infusion set during 3 days of use and demonstrate performance adequacy of the integrated     sensor and infusion set with glucose sensing and insulin delivery functionalities. The     hypothesis of this study is that having the infusion of insulin in close proximity to the     sensor does not interfere with the sensor accuracy. This study focuses on high bolus     patients. A high bolus is defined as 12 units or more.   "
115530|NCT01773655|"     The goal of this protocol is to determine the prevalence of somatic and germline mutations in     BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary     uveal melanoma (UM), or metastatic UM seen at our institution.   "
115531|NCT01773642|"     With increased availability of antiretroviral therapy (ART) and improved care, increasing     numbers of perinatally infected children are surviving into adolescence. While HIV care and     treatment programs are expanding, growing challenge faced by health providers and caregivers     is diagnosis disclosure to HIV infected children.      The investigators propose a 4 year project to test the effectiveness of a     cognitive-behavioural intervention that the investigators have designed to support     developmentally appropriate disclosure to HIV infected children by their caregiver.      The investigators hypothesize that the intervention will lead to increased disclosure rates     and will over time improve health and mental health outcomes among caregivers and children in     the intervention group compared to those receiving standard care. The findings of the study     will inform Ugandan and other countries' national policies on pediatric HIV care and     treatment.   "
115532|NCT01773629|"     The investigators will evaluate effects of introducing the care manager on:        1. Patient receipt of timely diagnosis and initiation of treatment for major depression          (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and        2. Patient continuity of care for depression across the transition of care from pregnancy          to postpartum (within 4 months postpartum).   "
115546|NCT01773447|"     The investigators hope to compare two different methods of closing skin wounds using sutures.     One of these methods (the set-back technique) was recently described in 2010 and has been     reported to be technically easier and reduces the chance of spitting sutures (deep sutures     that are pushed to the surface of the skin as the wound heals). The other method (the     vertical mattress technique) has been used for many years with good results. However, no     controlled studies have been performed to clearly demonstrate a difference between the two     methods. We hope to find differences in the height of the wound edges immediately after     surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms     associated with the scar 3 months after surgery.   "
115533|NCT01773616|"     The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE)     remains a challenge, particularly when there is renal involvement (lupus nephritis). For the     last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but     they are associated with significant toxicity.      Although randomized placebo controlled trials of Rituximab in non-renal lupus and lupus     nephritis did not meet their primary end-points, there is accumulating data that suggests     that B cell depletion with Rituximab may be efficacious in lupus disease refractory to     conventional therapy. Furthermore, our pilot data suggests that the addition of Rituximab to     mycophenolate mofetil (MMF) without oral steroids is at least as effective at inducing a     renal response as the standard of care therapy comprising MMF and high dose oral     corticosteroids.      RITUXILUP is a proof of concept, open labeled, randomized, controlled, multicentre trial that     aims to demonstrate whether the addition of Rituximab to MMF therapy is useful in treating a     new flare of lupus nephritis and whether it has a long lasting steroid-sparing, beneficial     effect with equal efficacy and greater safety than a conventional regimen of MMF and oral     prednisolone. If successful, this trial has the potential to dramatically change the     management of lupus nephritis.   "
115534|NCT01773603|"     Choosing the best embryo for transfer has become the major challenge in in vitro     fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has     added embryo development kinetics as another selection criterion.      This study was designed to select for the top blastocyst to be replaced, while increasing the     pregnancy chance, with the local legislation regulating the number of embryos to be     transferred and to establish a morphokinetic standard to be used in our clinical setting.   "
115535|NCT01773590|"     The aim of this study is to investigate the mechanisms of interplay between allergy (IgE and     Th2 mediated inflammation) and virus infection in the development of asthma, as well as the     risk and severity of acute exacerbations of asthma. Understanding these mechanisms should     identify new approaches for novel therapies for the prevention of asthma development and for     prevention/treatment of asthma exacerbations. Such treatment has potential to have a major     impact on patient quality of life and to result in enormous reductions in health care costs.      A human model will be used to identify dysregulated genes/proteins and determine     relationships with disease outcomes. This study will compare lower airway responses between     asthmatic and healthy control subjects undergoing rhinovirus (RV) experimental infection     (subjects will be infected with rhinovirus as part of the study). This will have the dual     advantage of investigating mechanisms in the most natural model possible, as well as     developing a better model for testing novel therapeutic approaches. The investigators will     analyse the samples from both subject groups, to determine their relevance to the human     disease. Any genes/proteins shown to be dysregulated and related to disease outcomes in the     human model will be very strong candidates for immediate translation into human intervention     studies.      Up to 12 asthmatic and/or healthy subjects will be recruited for a preliminary pilot study.     These subjects will be ineligible to enter the main study due to the presence of neutralizing     antibody to RV16 (~50% of subjects otherwise suitable for the study). These subjects will     meet all other inclusion/exclusion criteria for the main study. The 12 participants will     undergo tests including a single bronchoscopy, nasal sampling and blood tests allowing for     optimisation of all sample processing techniques. They will not be infected with RV-16.      In the main study the investigators will aim to study up to 15 healthy volunteers and 15     volunteers with moderate asthma (all on inhaled steroid treatment). Subjects will undergo a     single baseline bronchoscopy 2 weeks prior to inoculation with the RV16 virus. Following     infection with the virus participants will be required to attend for regular sample     collection including 2 further bronchoscopies post-infection. Patients will be followed until     convalescence 6 weeks post infection.   "
115539|NCT01773538|"     The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be     used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with     cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can     serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the     Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).   "
115540|NCT01773525|"     The purpose of this study is to test the use of a tool (NOTSSdk)to assess and provide     feedback to trainee surgeons' non-technical skills. It focuses on two aspects: reliability of     ratings of trainee surgeons using NOTSSdk; and the content and quality of feedback given to     trainees based on observations using NOTSSdk.   "
115541|NCT01773512|"     -  The prediction of extent and risk profile of coronary atherosclerosis based on clinical          evaluation and non-invasive techniques.        -  Detailed analysis of plaque volume, plaque composition, risk plaque features and shear          stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel          reconstruction.        -  Prediction of changes in coronary arteries based on changes in non-invasive          examinations.        -  Examination of WSS influence on atherosclerosis development and changes of WSS during          lipid lowering therapy.   "
115542|NCT01773499|"     Skin and soft tissue infections represent a tremendous burden to the health care community     with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in     2005. A Cochrane review of cellulitis found that there is limited data to support any     specific antibiotic or even a specific length of antibiotic therapy, and that outpatient     therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility     in differentiating cellulitis from abscess but its role in patients with cellulitis is not     well developed. Although speculative, the investigators hypothesize that sonographic features     of cellulitis are associated with clinical improvement and successful therapy following     antibiotics for patients with cellulitis.   "
115543|NCT01773486|"     This study will examine whether hesperidin, a major component of citrus fruits, affects how     the body responds to insulin in healthy and obese people. Laboratory studies suggest that     hesperidin treatment lowers blood pressure, lowers blood sugar and increases blood flow. This     study will see if hesperidin improves insulin resistance or insulin's effects on blood flow     in people with insulin resistance.      Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for     this study. Participants are randomly assigned to take hesperidin or a placebo (inactive     dummy pill ) for a 4-week treatment phase.   "
115544|NCT01773473|"     The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25     (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with     Type 2 diabetes mellitus (T2DM).   "
115545|NCT01773460|"     Everolimus will be given to patients with metastatic breast cancer who already has a progress     taking Everolimus but with a change in the endocrine treatment.   "
115571|NCT01773109|"     This Phase 2 study is designed to characterize the objective response rate (defined as     complete response (CR) and partial response (PR)) of Etirinotecan pegol administered to     subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37     eligible subjects will receive the investigational drug q3 weeks until they are no longer     benefiting.   "
115572|NCT01773096|"     The purpose of this study is to determine whether the routine use of methylnaltrexone in the     post-operative pediatric spinal fusion patient will decrease the incidence of constipation.   "
115547|NCT01773434|"     This is a multicenter, multiple doses, open-label Phase 1 study of MORAb-004 in subjects with     solid tumors. Subjects may have any solid tumor without intracranial involvement or     metastases that has failed standard chemotherapy.      This study will be conducted in 2 parts: 1) Part 1 will be the dose escalation portion of     this study to assess the tolerability and the safety profile of MORAb-004. Dose will escalate     in different cohorts as follows: 2, 4, 8 and 12 mg/kg weekly dosing each as a 4-week cycle     with no intra-subject escalation. Individual participants may have additional cycles at the     same dose until disease progression unless the participants meet the discontinuation     criteria.      2) Part 2 will comprise cohort expansions to further characterize the safety and tolerability     of MORAb-004 and to assess preliminary efficacy and the pharmacokinetic/pharmacodynamic     relationship of MORAb-004 in gastric cancer and hepatocellular carcinoma (HCC). Three dose     levels will be expanded based on the safety profile that was obtained in the dose escalation     portion of this study (Part 1): 4 mg/kg (administered on a weekly basis), 8 mg/kg     (administered on a weekly basis) and 12 mg/kg (administered every OTHER week).   "
115548|NCT01773421|"     This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of MTD     for BID Dosing).Part A will be initiated first, and Part B will be initiated after the PK     results of Part A have been evaluated.   "
115549|NCT01773408|"     This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating     doses of RO5503781 as a single agent or in combination with cytarabine in participants with     acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as     a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine.     An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline     may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized     formulation of RO5503781 in combination with cytarabine will be assessed.   "
115563|NCT01773213|"     In this randomized, double-blind clinical trial including patients with a neurogenic lower     urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury     Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor     contraction during the ice-water-test is provoked by the ice water or the rapid filling.   "
115603|NCT01772693|"     This is a feasibility study to evaluate the safety and initial effectiveness of unilateral     ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from     medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system     compared to a Sham Vim thalamotomy procedure.      Data will be collected to establish the basic safety of this type of treatment as the basis     for later studies that will evaluate its full clinical efficacy. The Sham treatment data will     be used to evaluate placebo effect from treatment.   "
115550|NCT01773395|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational intervention to learn whether the intervention, in this     case, the GVAX vaccine, works in preventing your MDS, CMML, or AML from relapsing after your     allogeneic stem cell transplantation. Investigational means that the vaccine is still being     studied and that research doctors are trying to find out more about it-such as the side     effects it may cause, and if the vaccine is effective. It also means that the FDA has not yet     approved the vaccine for your type of cancer.      You are being asked to participate in this trial because you have advanced myelodysplastic     syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or acute myeloid leukemia (AML). Your     doctor has determined that you are a candidate for an allogeneic stem cell transplant as     treatment for your MDS/CMML/AML. Allogeneic stem cell transplantation is a standard treatment     for MDS/CMML/AML. It can be effective because the cells from your donor (also known as the     graft) could form a new immune system that can fight against the MDS/CMML/AML cells in your     body. This is also known as the graft-versus-leukemia or GVL effect. In patients with     advanced MDS, CMML, or AML that is not in remission at the time of transplantation, as in     your case, relapse remains the number one cause of transplant failure. As such, this clinical     trial is designed to assess whether adding a leukemia vaccine early after transplantation     could stimulate donor cells to fight your cancer and improve transplant outcomes.      In recent years, researchers at the Dana-Farber Cancer Institute have discovered that GVAX, a     vaccine made from the patient's own cancer cells engineered to produce a protein called     GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.     GM-CSF is a naturally occurring hormone in the body that helps the immune system fight     infections and diseases. The GVAX vaccine is made in the laboratory by using a virus (called     adenovirus, which has been modified so it cannot cause illness) to insert the GM-CSF gene     into tumor cells. The cells are then irradiated, which prevents them from being able to grow,     before being administered to patients in a series of vaccinations.      A previous phase I clinical trial using this GVAX vaccine in patients with MDS/AML after     allogeneic transplantation demonstrated that the GVAX vaccine is safe, and the survival     outcomes were encouraging. The current randomized phase II study will investigate this     vaccine further and gather more information to assess the activity.      If you participate in this research study, you will be randomized to receive either GVAX     vaccination or placebo (a saline solution) vaccination. Randomization means that you are put     into a group by chance. It is like flipping a coin. There is a 50% chance that you will     receive the GVAX vaccine and a 50% chance you will receive placebo. Neither you nor your     transplant doctor(s) will know which you will be receiving.      The primary goal of this trial is to assess if there will be a difference in the percentage     of cancer free survivors in the vaccinated vs. placebo group at 18 months after transplant.   "
115551|NCT01773382|"     The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight     reduction. The investigators hypothesized that benefits of weight loss may reduce     proteinuria.   "
115552|NCT01773369|"     Early childhood injuries such as perinatal (around birth) stroke are devastating because the     child lives with the problem for life, typically close to a normal lifespan. One     'opportunity' presented by a brain injury early in life compared to later in adulthood is     that the young brain is much more plastic (malleable) and receptive to interventions. This is     particularly true for neural circuits that are still under development. We will test the     hypothesis that early (<2 yr old), intensive leg training will improve walking more than no     training or training at >2 yr old. We will further determine the changes induced by training     in motor and sensory pathways.   "
115553|NCT01773356|"     The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in     women.   "
115554|NCT01773343|"     To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with     1 versus 3 months intervals   "
115555|NCT01773330|"     This study is using a new technology known as high resolution manometry which is used to     evaluate patients that have trouble swallowing or have chest pain that is not related to the     heart. The investigator wants to learn how the different positions of the body, in a lying     position, semi-recumbent, sitting position or standing up, and the amount of liquid affects     the outcome of the test. This will help the investigator to determine a standardized protocol     for patients with trouble swallowing.   "
115573|NCT01773083|"     The purpose of this international multi-center double-blind randomized placebo-controlled     trial is to determine the effect of nebulized heparin, compared to placebo, on the number of     ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring     mechanical ventilation.   "
115574|NCT01773070|"     A follow up study designed to obtain long term data on subjects who either achieved a     sustained virologic response or did not achieve a sustained virologic response in an Abbott     sponsored hepatitis C study.   "
115556|NCT01773317|"     A prospective randomized controlled trial will be used to evaluate the efficacy of     post-operative perturbation training. 80 patients who were regular participants in activities     that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in     age from 14-40 at the time of injury are eligible. All eligible subjects must undergo     anterior cruciate ligament reconstruction by a single surgeon using quadrupled hamstring     autograft or soft tissue allograft and the designated preoperative and postoperative     rehabilitation at University of Delaware Physical Therapy clinic. Using a prospective     randomized design, 40 subjects who received University of Delaware Physical Therapy     post-operative treatment protocol will be block randomized by sex to 40 patients who will     receive 10 sessions of post-operative perturbation training in addition to standard agility     and return to activity progression and forty who receive only standard agility and return to     activity progression. Post-operative perturbation training will be initiated when the athlete     is at least 8 weeks post-anterior cruciate ligament reconstruction, has full range of motion     and achieves 80% quadriceps strength symmetry, the criteria we currently use for beginning     return to activity progression.   "
115557|NCT01773304|"     The purpose of this randomized, controlled, cross over single meal study is to investigate     the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for     their intake. The results from this project will increase our knowledge about nutritional     value of dairy proteins, which is necessary to decide whether dairy products can be     recommended for prevention of weight related bone loss.   "
115558|NCT01773291|"     The purpose of this study is to determine the therapeutic effect of acupuncture on severe     head injury under conventional treatment. A double-blind clinical trial is conducted up to 6     weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.   "
115559|NCT01773278|"     Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation     and antioxidant medication. They are carefully monitored with visits to clinic, laboratory     testing including cholesterol and 7-dehydrocholesterol levels, vitamin levels, blood counts     and liver and kidney function. On an annual basis, the patients undergo a series of tests     under anesthesia, including electroretinogram (ERG), brainstem audiometry (ABR), and     ophthalmologic exam under anesthesia to follow pigmentary retinopathy.   "
115560|NCT01773252|"     The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow     Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to     the results of transesophageal echocardiography (TEE).      RLS intracardiac shunts are associated with a number of clinically important syndromes     including paradoxical thromboembolism (causing stroke or other systemic infarct), migraine     headaches (particularly with aura), desaturation with obstructive sleep apnea, and     decompression illness. From a research perspective, the detection of shunts in subjects with     these types of syndromes is critical in helping to define the role of RLS in these disease     processes. From a clinical perspective, shunt detection will be increasingly important in an     era where interventional procedures for repairing cardiac defects are available for subjects     determined to be at risk.      The currently accepted reference standard for detection of an intra-cardiac patent foramen     ovale/atrial septal defect (PFO/ASD) RLS is a transesophageal echocardiography (TEE), a     procedure that is invasive, uncomfortable, and requires conscious sedation.      Alternative options include transthoracic echocardiography (TTE) with injection of agitated     saline (with and without Valsalva strain), a procedure that is far less sensitive than TEE     due to the echocardiography imaging limitations seen in many adults.      Finally, transcranial Doppler (TCD) with injection of agitated saline (with and without     Valsalva strain) is a newer entrant into this arena that does not require sedation or any     invasive instrumentation.      The Cardiox Model 100 FDS utilizes an optical sensor positioned on the surface of the     subject's skin at the scaphoid fossa of the ear. Next, a predetermined dose of an indicator     dye, indocyanine green (ICG), is injected at a predetermined rate into a peripheral     antecubital vein of the subject while the subject performs a breathing maneuver called a     Valsalva maneuver. The exhalation by the subject into a mouthpiece connected to a pressure     transducer via a flexible tubing extension, or its equivalent (ie, performing the Valsalva     maneuver), is an essential step for all existing RLS detection methods. The Valsalva maneuver     by the subject creates a pressure differential between the right and left sides of the heart.     This Valsalva maneuver results in blood flow from the right side of the heart to the left     side of the heart through an ASD, and/or causes a PFO, if present, to open, also allowing     blood to flow directly from the right side to the left side of the heart without passing     through the lungs (pulmonary vasculature) for oxygenation.      The Earpads, including their fluorescence sensor arrays (FSA), are used to measure the     relative concentration (ie, fluorescence signal level) of ICG dye in the bloodstream as a     function of time. If a premature inflection or peak occurs in the ICG dye concentration level     at a time point prior to the rise and fall of the concentration associated with the main     bolus of indicator, then a RLS is present in the heart. The amplitude of this premature ICG     dye-dilution curve (referred to as RLS-indicator dilution curve) is used to subsequently     quantify the magnitude of the right-to-left shunt by ratiometrically comparing the amplitude     of this RLS indicator dilution curve to the amplitude of the main indicator dilution curve     associated with that portion of the injected ICG dye that follows the normal pathway from the     right side of the heart, through the lungs, and into the left side of the heart (referred to     as normal indicator dilution curve).   "
115561|NCT01773239|"     The purpose of this study is to test a new computerized training program as well as to find     out whether the computer training might help people who have schizophrenia. The investigators     will study the effects of the computer training on how people with schizophrenia think about     social interaction and on their social skills. At completion of training, TARA subjects will     show improvement on measures of social cognition compared to their baseline performance.   "
115562|NCT01773226|"     This prospective single-center study will evaluate the safety and tolerability of a single     dose of APS(TM) treated patients with OA of the knee who have failed conservative OA     therapy. The study will also evaluate efficacy by assessing patient pain and functionality.   "
128108|NCT01608243|"     The purpose of this study is to investigate the safety of different doses of sublingual     tablets of house dust mite allergen extracts in adults with house dust mite-associated     allergic asthma.   "
115564|NCT01773200|"     Aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate     of mortality and morbidity. Severe definitive neurological impairment can concern up to 30%     of patients in relation with elevated intracranial pressure, hemorrhage recurrence and     symptomatic cerebral arterial vasospasm. This latter complication is defined as a reversible     reduction of cerebral artery's diameter occurring between the 4th and the 14th day after     bleeding. Physiopathology is not well understood, but could involve endothelium, trough     endothelial progenitor cells (EPC). Circulating EPC are bone marrow-derived cells with     capacity of vasculogenesis and angiogenesis. EPC have been recognized playing a beneficial     role in cardiovascular disease and ischemic stroke. EPC have never been studied in aneurysmal     subarachnoid hemorrhage.      The primary objective of this study is to compare the number of circulating endothelial     progenitor cells between patients with a good neurological outcome (defined as a glasgow     outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale     = 3, 4 or 5).      Briefly, the number of circulating EPC will be measured at admission, and at day 3, 6, 10,     14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and     hospitalized in Teaching Hospital of Besançon (France). The neurological outcome will be     measured one year after subarachnoid hemorrhage.   "
115565|NCT01773187|"     The primary hypothesis of the study is that treatment with pacritinib results in a greater     proportion of patients achieving ≥ 35% reduction in spleen volume from baseline to Week 24     than treatment with BAT.   "
115566|NCT01773174|"     Study will assess PK/PD parameters and safety and tolerability of the study medication in     this age group   "
115567|NCT01773161|"     Children with cerebral palsy are at an increased risk of having their hips move partially or     completely out of joint. This can cause pain and restrict movement at the hip, making sitting     in a wheelchair uncomfortable and make personal care difficult. This condition may be treated     with surgery. Surgeons use x-rays taken before and after the surgery to determine whether or     not the surgery has been successful. However, it is also important to know whether the     surgery has improved life from the child or the caregiver's point of view. The investigators     will also evaluate if waiting for surgery affects the child. This information will be added     to results from a physical exam and an evaluation of the child's x-rays for a more complete     picture of how this surgery impacts the lives of our patients. It is predicted that that the     health-related quality of life of children with cerebral palsy will improve following     surgery.   "
115568|NCT01773148|"     The goal of this study is to assess the safety and effectiveness of the AXERA Access System     in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary     Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F     introducer sheath.   "
115569|NCT01773135|"     The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm     labor .   "
115570|NCT01773122|"     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in     subjects with acne vulgaris following 28 days of dosing.   "
115576|NCT01773044|"     Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine     and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.      Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II,     scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each.     Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg     lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control     group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol     30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.   "
115577|NCT01773031|"     A prospective intra-individual study to compare the image quality of magnetic resonance (MR)     pancreatography at 3.0 T and 1.5 T in patients with autoimmune pancreatitis.   "
115578|NCT01773018|"     Volitinib (HMPL-504) is a novel, highly potent and selective small molecule inhibitor of     c-Met kinase. In preclinical studies, it demonstrated strong in vitro and in vivo activity     against c-Met kinase and its downstream signaling targets and inhibited tumor cell growth.     This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and     dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary     anti-tumor activity of HMPL-504 at single doses and multiple doses.   "
115579|NCT01773005|"     The objective of this study is to compare the effectiveness and of perioperative use of     Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.   "
115604|NCT01772680|"     The primary aim of this study is to measure zinc status and related proteins in patients with     Thalassemia who have or do not have diabetes. The secondary aim will be to explore the effect     of zinc supplementation on glucose metabolism in patients with thalassemia.   "
130321|NCT01579201|"     The purpose of this trial is to determine the effective dose of carbetocin which would     prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective     cesarean delivery.   "
115580|NCT01772992|"     Men who have sex with men (MSM) continue to be the most heavily-impacted risk group in the US     HIV epidemic. Studies suggest that the majority of incident HIV infections among MSM are     attributable to sex with a main male sex partner. However, HIV prevention interventions that     target male-male couples are lacking. Because of this, Couples HIV Voluntary Counseling and     Testing (CVCT), an intervention that has been repeatedly shown to reduce HIV transmission     within heterosexual couples, has been adapted to US MSM couples. Additionally, novel evidence     demonstrates that antiretroviral therapy (ART) not only reduces morbidity and mortality among     HIV-positive persons, but also serves to reduce the risk of HIV transmission to a negative     partner by 96%. As adherence to ART is modifiable and levels of peer support have been shown     to increase ART adherence, this current study proposes to use CVCT combined with dyadic     adherence counseling (CVCTPlus) to improve linkage to care, retention in care, ART     adherence, and viral suppression among male-male couples using a cohort of 350 serodiscordant     (one HIV(+) partner, one HIV(-) partner) couples in the greater Atlanta, Chicago, and Boston     areas. Prospective couples (175 in each arm) will be followed for two years. At each visit,     they will receive HIV testing, and both partners will complete a study survey measuring     social and behavioral factors that may influence adherence, such as a couple's coping ability     and their concordance of agreements regarding outside sex partners. Additionally, couples in     the intervention arm will receive two additional sessions of Partner-STEPS.   "
115581|NCT01772979|"     This is a multicenter phase II study on trabectedin in advanced or recurrent ovarian cancer     patients with BRCA mutation and BRCAness phenotype.      The purpose of this study is to determine the feasibility in terms of objective response rate     by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients     with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.   "
115582|NCT01772966|"     Eligible subjects with chronic neck pain will be randomly allocated to one of two     intervention groups: real vs control spinal manipulation. They will receive three     intervention sessions.      H1: Chronic neck pain patients treated longitudinally over a series of three encounters in     one week by random assignment to treatment group with either of the dual delivery procedures     (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate     of self-report of group allocation at exit interview.      H2: Patients treated by the typical-control dual procedure over a typical sequence of     encounters (3 times in one week) will show statistically significant improvement in clinical     outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index     (NDI), range of motion and pressure algometry; compared to those treated by the     control-control dual procedure.      H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no     significant difference in self-report of group allocation or clinical outcome measures.      A total of 372 subjects will be recruited.   "
115583|NCT01772953|"     This is a prospective, open-label, nonrandomized, prospective clinical trial evaluating a     fixed regimen of treosulfan, fludarabine and low-dose total body irradiation (TBI) in     children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing     allogeneic hematopoietic cell transplantation (HCT). The primary hypothesis is that HCT with     a preparative regimen consisting of treosulfan, fludarabine and low-dose TBI will result in     overall survival (OS) comparable to historical rates observed with conventional myeloablative     regimens in the pediatric population. The preparative regimen will result in adequate     incidence of neutrophil and platelet engraftment, and acceptable rates of graft-versus-host     disease (GVHD), relapse and survival. The pharmacokinetic (PK) profile of treosulfan in     children will be comparable to that of adults previously studied.   "
115584|NCT01772940|"     In resource-limited setting, concerns remain regarding the emergence of virologic failure and     high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral     therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for     Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a     boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low     genetic barrier to resistance.      The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment-     naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP)     each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine     (3TC). The primary end point is the incidence of therapeutic (clinical and/or     virologic)failure by study week 24.   "
115585|NCT01772927|"     Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and     lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral     nutrition is not possible, insufficient or contra indicated. The product has been registered     in 18 countries in Europe via a decentralized procedure that ended 15th December 2010.      The present study want to evaluate the use of Numeta 13% as standard medical prescription in     the NICU of the university of Liege. It is a prospective, monocentric, non-interventional,     non comparative, open-labeled data collection of record keeping, nutritional intakes from the     bags, additional intakes as well as blood and urine biochemical markers currently evaluated     in the NICU.      The data will be collected only in VLBWI < 1500 g receiving Numeta G13% from day of birth     (day 1) until parenteral nutrition (PN) decreases below 20% of the targeted intakes 2 days in     a row as a quality control of the new solution in clinical practice.      Indication for PN and daily prescription will follow the protocol in use in the NICU on     behalf of the investigators   "
115586|NCT01772914|"     The purpose of this study is to determine whether copeptin levels are affected by food     intake.   "
115587|NCT01772901|"     The investigators will conduct a brief educational intervention to pregnant women who have     not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal     influenza vaccine.   "
115588|NCT01772888|"     Study aims: The primary aim is to determine whether chewing efficiency, determined by a     two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.   "
115605|NCT01772667|"     There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise     capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there     are no data available regarding long-term effects of this multimodal program. The aim of this     study is to investigate the long-term impact of a rehabilitation program 3 month after     finishing on exercise capacity and physical activity.   "
115589|NCT01772875|"     In patients with advanced multiple sclerosis, permanent urinary catheters are often used to     manage the urinary incontinence and bladder emptying problems. These catheters will lead to     urinary tract infection, blocking of the catheter etc.. Especially infections with certain     bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and     pseudomonas can pose a problem for the hospital infection control and for the patient.      This study wants to evaluate the potential role of regular bladder lavage with saline, a     solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in     the decontamination of these bladders and the prevention of clinically relevant urinary tract     infections.   "
115590|NCT01772862|"     The purpose of this study is to determine whether early rehabilitation intervention including     individualized physical training and social activities with a class mate at two weeks     intervals at the ped.onc. center will increase children with cancer's level of physical     performance   "
115591|NCT01772849|"     The purpose of this study is to determine whether early rehabilitation intervention including     educational and social activities with a class mate at two weeks intervals at the ped.onc.     center will increase children with cancer's level of education performance.   "
115592|NCT01772836|"     RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem     to treat bacterial infections, including those due to multi-drug resistant bacteria.   "
115593|NCT01772823|"     Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of     acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all     participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be     assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized     Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered     at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir     (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0,     4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the     study will be discontinued from the study agent and followed for an additional 24 weeks after     the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or     renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed     for an additional 48 weeks in the Extension Phase to more closely monitor longer-term outcome     of potential concerns.   "
115594|NCT01772810|"     This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation     for the treatment of chronic spinal cord injury.   "
115595|NCT01772797|"     The primary purpose of the study is to estimate the maximum tolerated dose of the combination     of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and     preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in     ALK-rearranged non-small cell lung cancer.   "
115596|NCT01772784|"     Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from     cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as     tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether     endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators     will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.   "
115597|NCT01772771|"     The main goal of this study is to perform standardized testing of tumor tissue to learn which     genes are mutated (have changed) to provide personalized cancer therapy options to patients     at MD Anderson. Your doctor may be able to use testing information on your tumor to identify     clinical trials that may be most relevant to you.      Another goal of this laboratory research study is to learn how often different genes mutate     in patients with different cancers. Researchers will also use the information learned from     this study to develop a database of the different kinds of mutations in cancer-related genes.      Researchers also hope to better understand how mutations in cancer-related genes may affect a     patient's response to different therapies. Researchers can use this information to select     specific therapies for future patients that are more likely to be effective.   "
115633|NCT01772303|"     This multicenter, prospective, open-label, outpatient study will assess the safety and     efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100     subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers,     diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis     and trauma wounds) of at least 4 weeks documentation.   "
115598|NCT01772758|"     Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated     premature death. Oxidative stress has been observed in patients with CF and exercise     intolerance has been shown to predict mortality in patients with CF, regardless of how     healthy their lungs are. A critical barrier to improving the quality of life and longevity in     patients with CF is our lack of knowledge regarding the different reasons why patients with     CF cannot exercise to the level of their peers. We have collected preliminary data to support     our central hypothesis that oxidative stress contributes to the impairment in blood vessel     function at rest and during exercise which ultimately oxygen transport and delivery resulting     in exercise intolerance. Exercise is therapeutic medicine for patients with CF and this     investigation represents a major breakthrough in the approach to begin understanding the     physiological mechanisms which contribute to exercise intolerance in these patients.   "
115599|NCT01772745|"     Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery     with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold     standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was     developed with the aim of reducing the invasiveness of conventional laparoscopy. In this     study we aimed to compare results of SILS cholecystectomy and three port conventional     laparoscopic (TPCL) cholecystectomy prospectively   "
115600|NCT01772732|"     The primary objective is to assess the safety and tolerability of multiple doses of Simotinib     Hydrochloride in NSCLC patients. The secondary objective is to determine the pharmacokinetic     (PK) profile and explore the preliminary anti-tumor activity.   "
115601|NCT01772719|"     The purpose of this study is to examine the effect of simvastatin and zoledronic acid on     M-protein and/or free light chains when added to conventional chemotherapy for the treatment     of multiple myeloma patients.   "
115602|NCT01772706|"     The purpose of the study is to assess in a randomized, double blind, controlled,     multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the     prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and     neck carcinomas.   "
130322|NCT01579188|"     The purpose of this study is to evaluate survival in inoperable stage III Non-small Cell Lung     Cancer patients following chemo-radiotherapy followed by GV1001 vaccination plus best     supportive care.   "
115606|NCT01772654|"     This study will evaluate a type of Magnetic Resonance Imaging (MRI) sequence called arterial     spin labeling (ASL). The investigators hope that ASL can better localize areas of the brain     (lesions) that cause epilepsy. This type of MRI does not require contrast, does not use any     radiation, and adds on 4 minutes to the routine MRI that is done for patients with epilepsy.      The study hypothesis is that in patients with refractory epilepsy, Arterial Spin Labeling     (ASL) MRI will show areas of abnormality in the brain to the same degree as single-photon     emission computerized tomography (SPECT) and positron emission tomography (PET) studies.   "
115607|NCT01772641|"     This study has three main aims. Aim 1: To provide initial data on the efficacy of combined     Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing     abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To     explore the possibility that SGR+VN will be particularly efficacious among smokers with     higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using     a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms underlying     the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced     cravings) of treatment effects.   "
115608|NCT01772628|"     The main objective of the study was to develop a novel intervention method which could reduce     the spread of Sexually Transmitted Infections (including HIV) and unwanted pregnancies by     improving parent-child communication using schools as gateways.      It was done in 22 public day and mixed secondary schools in both Kampala and Wakiso     districts. The study employed a cluster randomized controlled trial experimental design.     Eligible schools were purposively selected and stratified into urban, peri-urban and rural.     The schools were then matched into pairs for potential confounding variables such as religion     and gender. In total, 11 schools were randomly allocated to the intervention and an equal     number of schools to the comparison arms of the study.      A questionnaire was administered to students at baseline and post-intervention. This     questionnaire was validated in test re-test on approximately 200 S1 students from 2 schools     that did not participate in the intervention nor the comparison arm. A parents'/guardians'     questionnaire was also administered both at baseline then at post intervention. This     questionnaire was also pre-tested among approximately 200 parents of S1 students who     participated in the test re-test. The results of the pre-test were used to finalize the     questionnaire. To increase the extent to which questions were understood, the English     versions of questionnaires were translated into one of the widely spoken local language     Luganda.   "
115609|NCT01772615|"     Purpose: The purpose of the study is to investigate if treatment with ciprofloxacin for one     week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease     activity among ulcerative colitis patients with disease flare-ups compared to placebo     controls.   "
115610|NCT01772602|"     The purpose of this registry is to (A) better describe the incidence and prevalence of     Amyotrophic Lateral Sclerosis (ALS) in the United States;(B) examine appropriate factors,     such as environmental and occupational, that may be associated with the disease; (C) better     outline key demographic factors (such as age, race or ethnicity, gender, and family history     of individuals who are diagnosed with the disease) associated with the disease; and (D)     better examine the connection between ALS and other motor neuron disorders that can be     confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.   "
115621|NCT01772459|"     Research has shown that questionnaires completed on the internet have the potential to     provide more complete and honest data with fewer errors in a more efficient manner than     questionnaires completed using the paper and pencil format. Despite the numerous advantages     of internet-administered questionnaires, it is important to make sure that the internet     questionnaires will yield comparable results to the well-established paper and pencil     versions. No one has studied internet administration of scoliosis specific questionnaires in     adolescents with scoliosis. The investigators will test whether the internet administration     of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The     investigators predict that the internet-administered questionnaire will provide the same     reliability as the paper-administered questionnaires.   "
115611|NCT01772589|"     There have been considerable efforts to control rising health care costs. One of the more     recent developments is the practice of reprocessing single use medical devices. This practice     has been shown to provide considerable savings for health care payers. Medical devices have     been reprocessed in a number of different medical fields including Orthopaedic Surgery. One     of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These     saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision     saw blades are Health Canada approved and are available at Capital Health.      Beyond the benefits to the environment and cost savings, the investigators do not know if the     reprocessed saw blades work better, work worse or the same as non reprocessed saw blades.     This study is designed to determine if the reprocessed saw blades used during a TKA work as     well as a new saw blade.   "
115612|NCT01772576|"     The objective of this study is to gather data to establish the chronic safety, performance     and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.   "
115613|NCT01772563|"     The primary objective of the present study is to investigate the influence of     co-administration of itraconazole and volasertib on the pharmacokinetic profile of volasertib     without co-administration of itraconazole. Secondary objectives are to investigate safety,     tolerability and preliminary therapeutic effects following intravenous administration of     volasertib.   "
115614|NCT01772550|"     The purpose of this study is to compare multidetector computed tomography (CT) image quality     following peripheral venous high pressure injection of iodinated intravenous contrast media     between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18     GA non-fenestrated, intravenous catheter.      In the contrast enhanced CT procedure (CECT), a machine (power injector) is used to rapidly     deliver contrast agent to an individual's circulatory system. The contrast allows for greater     differentiation of tissues in images of the area of interest, affording a better opportunity     to visually assess the area and hence make a more accurate diagnosis.      CECT often requires a high rate of contrast flow (≥ 5 mL/sec) through the IV catheter to     provide sufficient contrast for an acceptable image. Typically an 18 GA IV catheter is     required to achieve these high flow rates; however, often the patient does not have a vein     that will accommodate this large size catheter. The BD Nexiva™ Diffusics™ IV catheter is     designed to deliver a higher flow rate than a conventional catheter of the same gauge by     incorporating fenestrations (small openings) near the tip of the catheter that allow fluid to     exit the catheter in addition to that which normally exits through the main opening at the     tip of the catheter.   "
115625|NCT01772407|"     The primary goal of this study is to compare in the long-term costs of laparoscopic or open     right colectomy in patients sustaining a colon cancer controling for the carcinologic     equivalence of the two surgical strategies. The secondary goals to compare long-term     mortality, morbidity as well as quality of life of the two groups.The present study is an     prospective multicentric observational trial taking into account the usual surgical strategy     of every centers   "
115615|NCT01772537|"     Alzheimer's disease represents a growing public health problem in developed countries.     Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid,     neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The     effect of anesthetic agents on changes in these proteins in humans is not well characterized,     but in-vitro evidence suggests that anesthetic agents can accelerate potential pathogenic     mechanisms, such as increasing amyloid formation or rates of apoptosis in cultured cells and     increasing amyloid levels in mice. Human data on the effect of anesthetic agents on amyloid     and tau proteins is limited to a small series of 11 patients and showed a significant     increase in tau levels after exposure to anesthetics. In this study the investigators propose     to measure CSF and serum biomarkers in a population of patients with normal CSF dynamics, who     are undergoing surgery for repair of a thoracoabdominal aneurysm. The investigators will also     obtain preliminary data on whether changes in CSF levels of these proteins are associated     with postoperative delirium or cognitive change.   "
115616|NCT01772524|"     The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single     dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24     weeks.   "
115617|NCT01772511|"     The purpose of this study is to assess patients' understanding of clinical trials and to help     researchers understand which areas of the informed consent need better explanation for future     cancer clinical trial patients.   "
115618|NCT01772498|"     This study is designed to take a first step toward testing the efficacy and acceptability of     heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress     in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides     clients with real time feedback about their heart rate variability (HRV) as a means of     teaching them how to breathe in a specific, therapeutic manner.      More specifically, this study has been designed to test several hypothesises. Each hypothesis     is based on the prediction that, in a sample of psychologically distressed PBT survivors, a     course of 8 HRVB sessions will demonstrate:        -  statistically significant reductions in levels of depression        -  statistically significant reductions in levels of anxiety        -  statistically significant increases in resting HRV        -  that reductions in anxiety and depression will be significantly, negatively correlated          with increases in resting HRV        -  that the HRVB will be viewed as an acceptable intervention by the participants      In addition to the hypothesises stated above, the study will also investigate in a discovery     oriented manner if the HRVB intervention will have positive impacts on the participants:        -  levels of sleep impairment        -  levels of pain   "
115619|NCT01772485|"     This project shall rigorously evaluate the effectiveness of a novel, neuroplasticity-based     internet-deliverable cognitive training program, which specifically targets the treatment of     core cognitive dysfunctions observed in adolescents with Attention Deficit Hyperactivity     Disorder (ADHD/ADD), to be tested in a clinical population in New Delhi, India.   "
115620|NCT01772472|"     This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab     emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer     who have residual tumor present in the breast or axillary lymph nodes following preoperative     therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6     mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or     hormone therapy will be given in addition if indicated.   "
115622|NCT01772446|"     Introduction: The Spanish Society of Family and Community Medicine, started the Program of     Preventive Activities and Health Promotion, which generates periodic recommendations of     preventive methods based on scientific evidence. In the last update it has become evident the     need of modifications to adapt the program to modern times and focuses on improving     accessibility and offering more flexible responses to users of the program. In this sense,     the mobile phone technology could be useful, specifically the messaging service to remind     patients their appointments and increase attendance rates. Main objective Compare the     percentage of patients in the intervention group compared with the control group who achieved     a figure of HbA1c <7% in 2013.Design: single blind Randomized Clinical Trial. Study     population: Patients with diabetes with or without hypertension or lipid metabolism disorder,     over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting     the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a     difference of 16% in the percentage of patients with HbA1c lower than 7% between groups:     Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps.     Control group: Routine clinical practice. Statistical analysis: The relationship between the     intervention received and the main variable (compliance with preventive activities at 12     months) were analyzed using a logistic regression model.   "
115623|NCT01772433|"     This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back     pain in female athletes.   "
115624|NCT01772420|"     This phase II trial studies how well lenalidomide and eltrombopag olamine works in treating     patients with symptomatic anemia in low or intermediate myelodysplastic syndrome.     Lenalidomide may stimulate the immune system in different ways and stop cancer cells from     growing. Eltrombopag olamine may increase the number of white blood cells and platelets found     in bone marrow or peripheral blood. Giving lenalidomide and eltrombopag olamine may be an     effective treatment for myelodysplastic syndrome.   "
115672|NCT01771796|"     The purpose of this study is to determine the potential benefits resulting from a specific     training on exercise tolerance and muscle function at the medium and long-time, as well as     study its effects on plasmatic mediators (sMICA, IGF-I and IGFBP-3) in patients with lung     cancer following resection surgery.   "
115626|NCT01772394|"     Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive     remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised     training cognitive therapy which addresses the difficulties in flexibility and holistic     processing that have been incriminated in AN. CRT has been found to improve AN's     neuropsychological functioning and short term outcome. To our knowledge, no French speaking     country has tested its effectiveness. Moreover, the question whether it is efficient for both     anorexic restrictive and anorexic binge-purging patients remains unanswered.      The aim of the present study is to determine if CRT in AN adolescents and young adults has a     favourable impact on cognitive functioning and clinical status. We will also explore whether     the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There     will also be an Historical Control Group of patients, sixty, who received traditional medical     interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study).   "
115627|NCT01772381|"     Introduction: Babies born at term by elective caesarean section (CS) and before onset of     labor are more likely to develop respiratory complications than babies born vaginally. In     developing countries resources are scarce and it is difficult to provide expensive treatments     as neonatal care.      Aim of the Work: To assess the effect of prophylactic dexamethasone administration before     elective cesarean section at term in reducing neonatal respiratory complications.      Patients and methods: 600 women were included in the study and were planned to have elective     caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before     delivery. 300 patients were the control group.      The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence     of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS)     and the need for mechanical ventilation.   "
115628|NCT01772368|"     The primary objective of this study is to evaluate the dose response, efficacy, and safety of     4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a     fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax®     Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of     age and older with persistent asthma.   "
115629|NCT01772355|"     Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure     that provides a sufficient amount of tissue material for standard histological and     immunohistochemical analysis and can be an alternative or supplement to fine needle     aspiration biopsy   "
115630|NCT01772342|"     Many individuals with chronic lung disease have night time symptoms that disrupt their sleep.     The purpose of this study is to determine the effects of an air purifying device (PureNight,     Halo Innovations, Minneapolis, MN) on sleep disruptions measured by a sleep watch     (actigraph) and individual perception of sleep quality.   "
115631|NCT01772329|"     The investigators propose a randomized controlled trial to evaluate the effects of treatment     intended to reduce pain catastrophizing among patients reporting high pain catastrophizing     prior to total knee replacement(TKR), total hip replacement(THR), or shoulder surgery in an     effort to thereby reduce the incidence of persistent post-surgical pain (PPP) and enhance     physical function at 3-months post-surgery. Preemptive treatment aimed at a known predictor     of PPP following total knee replacement is highly innovative and have potentially high impact     for public health. Cognitive therapy is a well-tolerated modality among chronic pain patients     with few if any side effects. Cognitive therapy (CT) represents an inexpensive method that     could greatly reduce suffering and costly post-surgical pain management for high risk TKR     patients.   "
115632|NCT01772316|"     This multicenter, open-label, single arm, long-term extension study will evaluate the safety     and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe     rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core     study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly     (for participants entering from WA22762) or every two weeks (for participants entering from     NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.   "
115817|NCT01769898|"     The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with     theophylline plus low-dose formoterol-budesonide in subjects with bronchiectasis.   "
115634|NCT01772290|"     This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of     coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or     an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of     non-childbearing potential. Subjects will be randomized to receive multiple oral doses of     vismodegib, alone or in combination with multiple oral doses of either rabeprazole,     itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.   "
115635|NCT01772277|"     To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at     osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).   "
115636|NCT01772264|"     The most notable tolerability finding from these multiple dosing studies has been the     occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this     finding, the current four week study is designed to examine whether a slow titration regimen     up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.   "
115637|NCT01772251|"     Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism     caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current     methods of insulin therapy for diabetic patients are multiple daily injection therapy and     continuous subcutaneous insulin infusion with an external pump. This rout of administration     may lead to hyperinsulinemia as insulin is administered in a non physiological way, targeting     mainly extra hepatic tissues (muscle, fat).      A method of providing insulin without the need for injections has been a goal in drug     delivery.      Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on biochemistry     and quantum theory of biochemical reactions. The carrier enables the absorption of proteins     from the gastrointestinal tract in their full structure. Oshadi has also developed the Oshadi     Icp - insulin, proinsulin and C-peptide in Oshadi carrier, administrated orally. This study     was design in order to evaluate the safety and feasibility of multiple administration of     Oshadi Icp   "
115638|NCT01772238|"     The objective of this study was to confirm if two formulations of amoxicillin and clavulanic     acid (suspension) are bioequivalent.      Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo     Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic     acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 35 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
115639|NCT01772225|"     The aim of this observational study is to identify and quantify the humanistic and economic     burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA     NSCLC in three European countries (France, Germany, and the United Kingdom [UK]). Data     collection will be conducted through patient medical record abstraction and patient survey.   "
115640|NCT01772212|"     The objective of this study was to confirm if two formulations of terbinafine (tablets) are     bioequivalent.      Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product     Lamisil® 250 mg (Novartis). One tablet was the single dosage.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 30 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
115641|NCT01772199|"     This is a randomized, parallel group, placebo-controlled study designed to assess whether     GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple     Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex     (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects     will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be     managed with their current standard of care therapy (Copaxone or Avonex). The total treatment     period is 48 weeks, including a standard 4 week titration period and 44 week maintenance     treatment period (which could be adapted to a 5-week titration and 43 week maintenance     period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg     (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will     be titrated to the maximum tolerated dose with the objective of titrating to the highest dose     (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The     post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of     treatment at Week 48 or early withdrawal, as appropriate.   "
115642|NCT01772186|"     Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in     people with Parkinson's disease (PD), and closely associates with postural instability and     fall. Previous studies had shown that somatosensory stimulation could induce weight shift,     and this is probably helpful for gait reinitiation. Therefore, the investogators propose a     two-year project to develop a wearable device, the somatosensory stimulation system (SSS),     which monitors gait real-time and provide somatosensory stimulation once FOG episodes     detected. And the investigators test the effects of this SSS device on FOG, fall, and walking     function.      Methods: The first-year study is to build and validate this wearable SSS device. The     customized device has sensor part and stimulator part; the former is an inertial sensor     module to detect FOG episodes, and the latter is a microvibrator-embedded insole to     facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are     recruited and conduct FOG-provoking tasks during their medication OFF or late On state in     a laboratory setting. The investigators test if the SSS device could facilitate lateral     weight shift and help gait reinitiation, as well as the reliability. The second-year study is     to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect     on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and     randomly assign them into the experimental and control groups. Both groups wear the SSS     device during the daytime for ten weeks, and the stimulator part is turned on during the     first six weeks (intervention phase) only in the experimental group. The stimulator part is     then kept off during the last four weeks (follow-up phase) in both groups. The effect of the     SSS device is evaluated by the outcomes including FOG severity, fall and walking function,     which are measured prior/after the intervention phase and after the follow-up phase.      Clinical relevance: This project tempts to combine real-time gait analysis with     somatosensory-induced postural readjustment, and using this novel approach to improve FOG and     fall in people with PD. The results of this projects might also provide an objective,     long-term assessment tool to measure the FOG phenomenon for clinical and research fields.   "
115818|NCT01769885|"     This clinical trial studies tivozanib before surgery in treating patients with localized     kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth     factors needed for cell growth.   "
115643|NCT01772173|"     Diabetic complications are an important source of blindness and mortality among Veterans.     Their occurrence is unpredictable because of the highly variable effect of factors such as     weight, diet and exercise. Improved prediction of diabetes complications has the potential to     improve the care for Veterans with diabetes, especially if this can be done without any extra     effort for the Veterans or their caretakers. All Veterans with diabetes in VHA are required     to undergo annual retinal photography to screen for current diabetic retinopathy. The     investigators have recently developed an automated, precise, fast, novel tool for measuring     retinal vessels in these images. Manual measurement of retinal vessels has shown that these     can predict future -not current- development of hypertension and also diabetic retinopathy.     If the investigators can confirm that their tool can flag those Veterans at increased risk     for developing these diabetes complications, this will allow earlier intervention and     prevention. Because the tool only uses the images that are being taken anyway, there is no     extra effort for either the Veteran or VA staff.   "
115644|NCT01772160|"     The purpose of this study is to collect data on the incidence, complications, economic burden     and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.   "
115645|NCT01772147|"     The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium     bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and     umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily     with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function,     COPD-related health status assessments and safety in COPD subjects.   "
115646|NCT01772134|"     The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium     bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily,     umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg)     twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on     lung function, COPD-related health status assessments and safety in COPD subjects.   "
115647|NCT01772121|"     This study will define the substantial disease burden associated with viral hepatitis in     India, and provide a foundation to understand the host and viral determinants of disease     pathogenesis that may ultimately impact treatment decisions and outcome   "
115648|NCT01772108|"     This trial is a randomized study of the MitraClip device in heart failure patients with     clinically significant functional mitral regurgitation. A hierarchical composite of all-cause     mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower     rate with the use of the MitraClip device in addition to optimal standard medical therapy     compared to optimal standard of care therapy alone.   "
115649|NCT01772095|"     In 1906, Dr. Alois Alzheimer first described the disease that later took his name. Today, 100     years later, 24 million people worldwide suffer from Alzheimer's disease or other dementias.      The term 'dementia' is clinical and is used to describe brain disorders that cause decline in     mental functions, memory first and then speech, judging and overall behavior. Alzheimer's     disease is by far the most common form of dementia, followed by vascular dementia, dementia     with Lewy, the frontotemporal dementias etc.      In Greece there are 141,000 patients with dementia. With increasing life expectancy, the     figures are expected to increase dramatically in the future.      Alzheimer's disease is the most common form of dementia, as well as 50-60% of patients with     dementia suffer from this disease. The second most common type of dementia is vascular, ie     that associated with cerebrovascular disease and is the 15-30% of all dementia cases and is     most common between the ages of 60-70 years and is more common in men than women. It is     estimated that 5% to 8% of people over 65 suffer from dementia, while in industrialized     countries ranges at the following levels :15-25% over 85 and 32% over 90 years.      Dementia is characterized by a slow onset and progressive course. The syndrome includes     disorders in general intelligence, learning and memory, problem solving, perception,     judgment, executive function, language and synergy of movement, but without impairment of     consciousness.      Alzheimer's disease is a neurodegenerative disorder with distinct clinical and     histopathological features, although with variations from person to person.      In its early stages it is sometimes difficult to diagnose cognitive impairment from normal     aging of the brain. With the passage of time, the continuous decline in recent memory,     fluency, ability for spatial orientation ultimately restricts the autonomy regarding basic     activities of daily life such as managing finances. The anxiety and depression complicate     diagnosis in early stages, but gradually decline with loss of sensitivity. Intermediate     stages of the disease require increasingly supervision in daily self-care activities, such as     personal hygiene and clothing. In the advanced stages are usually essential nursing care in     institutional context.      The severity of symptoms of the disease varies and is determined by premorbid factors such as     education, gender, cultural background. Epidemiological studies have shown as protective     factors against the onset of dementia, higher education, taking estrogen and     anti-inflammatory drugs. On the other hand, age, family history of dementia, head injury,     hypertension and Down syndrome are risk factors for developing the disease. Finally, some     genetic factors appear to be protective, and other pressures to the disease.   "
115650|NCT01772082|"     Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated website     to promote walking and physical activity. Primary outcome is daily step counts. Intervention     lasts 3 months.   "
115651|NCT01772069|"     Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though     rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia     can bring out the disability in daily life, the majority of previous reports only ascertained     no significant association between the presence of fibromyalgia and the severity of SLE.      It is necessary to make unremitting effort to reduce the mortality and life-threatening     disease flare-up due to SLE disease itself. Additionally, we think that physicians need to     pay more attention to improve health-related quality of life (HRQoL) in the patients with     SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease     duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the     clinically important and constructive theme to investigate that which is the most important     factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration.      The objective of this study is to evaluate the degree of contribution of fibromyalgia for     reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with     SLE.   "
115652|NCT01772056|"     The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term     treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of     AD, but not its efficacy and security to reduce or prevent relapses.      Objectives To investigate long-term management (16 weeks) of AD with fluticasone propionate     (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an     acute flare of AD with FP cream.   "
115653|NCT01772043|"     We will utilize the Cooperative International Neuromuscular Research Group (CINRG) network to     collect and store tissue and blood from patients with Duchenne muscular dystrophy (DMD) with     specific genetic mutations within the dystrophin gene that could be treated by antisense     oligonucleotide (AO) drugs.   "
115654|NCT01772030|"     The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after     cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein     reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac     echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our     current method of ICE-guided recordings from a conventional mapping catheter with high output     pulmonary venous pacing.   "
115655|NCT01772017|"     To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating     subjects with Obstructive Sleep Apnea (OSA) and snoring.   "
115656|NCT01772004|"     This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting     programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects     with selected tumor indications. New recruitment is open for all active cohorts.      Active cohorts: Escalation revised dosing regimen cohort.      Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum),     metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary),     mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian     cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma     (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant     prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy),     gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first     line) and escalation phase .   "
115657|NCT01771991|"     The purpose of this study is to determine if topical superoxide dismutase is an effective     treatment of radiation related neck fibrosis, and to determine the quality of life impact     from radiation related fibrosis in the head and neck cancer patients at Sanford Health.   "
115658|NCT01771978|"     Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG)     surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery     clamping. The aim of this study was to compare the preventive effects of diltiazem and     N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and     oxidative stress during off-pump CABG surgery.   "
115659|NCT01771965|"     The goal of this research plan is to test the effectiveness of a brief, cognitive behavioral     (CB) intervention to promote behavioral health treatment engagement among at-risk Veterans     who call the Crisis Line but are resistant to behavioral health services.   "
115660|NCT01771952|"     The purpose of this study is to determine how safe a knee injection called Synvisc-One® is in     patients with a condition called chondromalacia patella and how well in works in treating the     condition.      Chondromalacia patella is a common cause of kneecap pain or front knee pain. Often called     Runner's Knee, this condition often affects young, otherwise healthy individuals.      Chondromalacia is due to irritation of the undersurface of the kneecap. The undersurface of     the kneecap, or patella, is covered with a layer of smooth cartilage. This cartilage normally     glides effortlessly across the knee during bending of the joint. In some individuals, the     cartilage on the undersurface of the knee cap becomes irritated and soft, resulting in pain.     Potential treatments for this condition include rest, injections (numbing or     anti-inflammatory medications to reduce swelling and pain), and/or guided strengthening     exercises which may help reduce pain.      Other Treatments are being evaluated. This study is about Synvisc-One® an experimental device     that has been approved by the Food and Drug Administration (FDA) for the treatment of pain in     osteoarthritis (OA) of the knee in patients who have failed to respond to treatments that do     not involve drugs or surgery and simple pain medication such as acetaminophen. Synvisc-One®     is a gel-like substance that, when injected into a joint, acts to lubricate and cushion the     joint. Synvisc-One® is made from hyaluronan, which is a molecule that is found normally in     joint fluid.      Synvisc-One® has not been proven to be safe or helpful in patients with chondromalacia     patella (cartilage irritation or softening of the undersurface of the 'knee cap'). So far,     this drug/device has been given to over 10,000 people who have knee pain (due to     osteoarthritis) and has been proven safe and effective in patients with moderate to severe     pain due to knee joint osteoarthritis.   "
115661|NCT01771939|"     The purpose of the study is to evaluate the difference in Early Treatment Diabetic     Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups     of 30 eyes each affected by idiopathic epiretinal membranes that underwent     phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM)     peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5     years.   "
115662|NCT01771926|"     The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle     intervention in overweight and obese glucose intolerant adults. We will evaluate the effects     of the consumption of potatoes (high or low resistant starch) vs. commonly consumed     carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption     alters markers of lipid metabolism and inflammation in the context of a lifestyle     intervention program.   "
115663|NCT01771913|"     The purpose of this study is to investigate if there is a relationship between the take of     fat grafts with and without ADSCs and the presence of specific surface markers on the cells     of the stromal vascular fraction.   "
115664|NCT01771900|"     The purpose of this feasibility study was to obtain pilot data, as the basis for a future,     larger investigation, testing the impact of an innovative training camp intervention called     HEART CAMP (Heart failure Exercise And Resistance Training CAMP) to teach HF patients how to     exercise and self-manage exercise behavior over time. The study assessed the feasibility and     adequacy of the intervention, the data collection plan, and the reliability and sensitivity     of the outcome measures. The 6-month intervention was based on a training camp model to teach     HF patients how to exercise in a fun, group-oriented atmosphere. Subjects interacted and     exercised in small groups with an exercise physiologist and nurse to guide activities. The     dosage of the intervention (frequency and amount of direct guidance from the exercise     physiologist and nurse) decreased over the 6 months in order to increase subject's     independence and promote long-term adherence to exercise. The intervention incorporated use     of computerized data files to monitor exercise behavior, compare exercise performance to     individualized goals and provide feedback as strategies to foster adherence and     self-management of exercise behavior.   "
115680|NCT01771692|"     Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a     lot of research into the factors that can affect the speed of alignment of teeth but there     has been very little research on how different techniques of wire attachment to the brace     (ligation) can affect this.      The randomised clinical trial of 100 patients aims to compare the speed of alignment of the     lower (mandibular) front teeth (incisors) using two different techniques over a period of 12     weeks. Both techniques use the conventional small elastic rings (modules) that are placed     over each metal square (bracket) but they will be tied in a different configuration for each     group. We will also observe any differences in the distances between the corresponding teeth     either side of the lower jaw for each group and the bracket failure rates.   "
115665|NCT01771887|"     Diabetes mellitus is a disease of great frequency and is a major public health problem. In     Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year     2025. Given the increasing prevalence of diabetes in Lebanon, the evolution of complications     of this disease and the lack of studies at this level, it is appropriate to conduct a study     that aims to evaluate the effects an education program for people with type 2 diabetes on     their sense of self-efficacy and their ability to self-manage their disease to make them the     most optimal therapeutic adherence possible. The design of this study is experimental type     before / after randomization by diabetic patients. Education program delivered to the     experimental group is the Accu-Chek Education Program of Roche. Membership will be assessed     using a biomarker HbA1c should be <7%, and a questionnaire (Summary of Diabetes Self-Care     Activities Measure), which measures self-care behaviors. Self-efficacy is measured using the     Diabetes Management Self-Efficacy Scale. And this before the intervention and 3 months later.     The sample will be 240 diabetic patients T2. Recruitment will be in outpatient diabetology a     Hospital located in Beirut. Statistical analyzes used for descriptive variables are measures     of central tendency, dispersion and frequency distribution. T-test and chi-square will be     used to compare the socio-demographic characteristics of the 2 groups, experimental and     control. To test hypotheses and determine the difference in the results of the dependent     variables of the 2 groups, analysis of variance and covariance are used. The data will be     processed using SPSS version 14.0.   "
115666|NCT01771874|"     The purpose of this study is to determinate the effect of a pre-treatment with bupropion, a     dopamine and norepinephrine transporter inhibitor, on the pharmacodynamics and     pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The study will     provide further understanding of the dopaminergic regulation of mood.   "
115667|NCT01771861|"     The aim of the study is to establish the predictive properties of our trauma team activation     protocol, and its individual criteria, and if possible to suggest changes that reduce over-     and undertriage.      The study will also give an overview of the frequency and type of emergency procedures at a     university hospital trauma center, which can contribute to optimal resource use and indicate     which type of surgical skills are necessary in our trauma emergency procedures.   "
115668|NCT01771848|"     The study is designed to establish the best dose to safely infect healthy individuals with     Plasmodium falciparum sporozoites (PfSPZ) by injection.      The goal of this study is to achieve infections in human volunteers with infection rates of     100% and pre-patent periods of less than 12 days.   "
115669|NCT01771835|"     Measurement of the circulation in patients with diabetes mellitus and establish a link     between retinal venous pressure (RVP) and endothelin (ET-1)levels.   "
115670|NCT01771822|"     This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to     cause irritation after repeated topical application to the healthy skin of human subjects     under controlled conditions.   "
115671|NCT01771809|"     Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will     receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of     the drug.   "
115673|NCT01771783|"     The primary objective is the characterization of the RAS peptide profiles after single and     repeated oral administration of a renin inhibitor, an ACE inhibitor and an angiotensin     receptor blocker in healthy volunteers.      Secondary objectives are the correlation of RAS peptide profiles with pharmacokinetic     profiles of the different RAS inhibitors and with pharmacodynamic parameters such as blood     pressure and heart rate. Output of the classic RAS system will be assessed using aldosterone     concentrations. Fluid and sodium intake will be monitored using sodium concentration and     total volume in 24h urine.   "
115674|NCT01771770|"     The hypothesis is that the pressure in the retinal veins increases from chronic lack of     oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this     hypothesis should be verified. At the same time the adaptation capacity of the blood     circulation should be analyzed, and a relationship to mountain sickness should be found.   "
115675|NCT01771757|"     The hypothesis is that the pressure in the retinal veins increases under a short-term lack of     oxygen and leads to a decreased blood circulation. On the basis of measurements in the     hypobaric chamber this hypothesis should be verified.   "
115676|NCT01771744|"     This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass     (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional     laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric     banding.   "
115677|NCT01771731|"     Our primary objective is to assess whether inhaling vaporized cannabis ameliorates chronic     pain in patients with sickle cell disease (SCD). As these patients will all be on chronic     opioid analgesics, the investigators will also assess the possible synergistic affect between     inhaled cannabis and opioids. The investigators will also assess the clinical safety of the     concomitant use of cannabinoids and these opioids in patients with SCD by monitoring the     short-term side effects associated with combined therapy. Finally, the investigators will     evaluate the short-term effects of inhaled cannabis on markers of inflammation and disease     progression in patients with SCD.      Hypotheses are as follows:        1. Inhaled cannabis will significantly reduce chronic pain in patients with SCD.        2. Inhaled cannabis will significantly alter the short-term side effects experienced by          patients who take opioids for SCD.        3. Inhaled cannabis will significantly alter markers of inflammation and disease          progression in patients with SCD compared to placebo.   "
115678|NCT01771718|"     The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image     in-vivo pigmented and non-pigmented human skin lesions for characterization of their     morphologic and functional features. .   "
115679|NCT01771705|"     The purpose of this study is to compare two different ways of monitoring the immune system to     determine how to manage the doses of anti-rejection medications.   "
115681|NCT01771679|"     The purpose of this study is to determine whether a one-time injection of allogeneic     mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the     face.   "
115682|NCT01771666|"     To determine concordance between isosulfan blue (ISB) and indocyanine green (IC-GREEN™) in     the identification of lymphatics and arm-draining nodes during nodal staging procedures in     breast cancer.   "
115684|NCT01771640|"     ALS is a debilitating disease with varied etiology characterized by rapidly progressive     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment     that has been found to improve survival but only to a modest extent. It lengthens survival by     several months, and may have a greater survival benefit for those with a bulbar onset. It     also extends the time before a person needs ventilation support.Stem cell transplantation is     a new hopeful way to improve the patients conditions and reduce the period of disabilities.   "
115685|NCT01771627|"     This pilot clinical trial studies varenicline or nicotine patch in promoting smoking     cessation among current smokers. Varenicline or nicotine patch may help people stop smoking   "
115686|NCT01771614|"     The effects of exercise on glucotoxicity will be determined in healthy subjects. Experimental     hyperglycemia will be induced via a constant- or fluctuating-rate glucose infusion to     establish different patterns of glycemic variability. The outcomes of hyperglycemia will be     determined by measuring pancreatic endocrine function, insulin sensitivity, endothelial     function, and oxidative stress.   "
115687|NCT01771601|"     Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The     commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2     (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to     test for their relative sensitivity for low oxygen levels just after birth on term infants     born by elective caesarean section. Reproducibility will be examined by replacements of the     sensors six times the next day when the infant is stable and quiet. The Adult Somasensor     (INVOS) will be used together with the OxyPrem sensor.   "
115688|NCT01771588|"     It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier     will be equal or superior to the growth of preterm infants receiving a currently marketed     human milk fortifier with a lower protein content.   "
121686|NCT01693146|"     Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and     hypercapnia.      Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD     patients with hypercapnia.   "
115689|NCT01771575|"     Traumatic brain injury (TBI) is a major worldwide health issue. Figures from the Centers for     Disease control show that 1.7 million people suffer a TBI annually. Meanwhile the World     Health Organization recognizes TBI as one of the most significant health issues in developing     countries. In the military, mild traumatic brain injury (mTBI) is one of the most frequent     sequela of modern war. Dizziness and balance disorders are the most frequent sequela of mTBI     and account for a significant degree of mTBI morbidity. At the current time, the best     treatment modality for dizziness secondary to mTBI is vestibular rehabilitation (VR). While     VR is effective, the therapy is time consuming, not universally successful, and results in     incomplete recovery by many patients. Work needs to be done in an attempt to improve therapy     outcomes. This project will study the use of neuromodulation (through stimulation of the     tongue) as an adjuvant to improve the effectiveness of VR and reduce the time involved in VR.     Given past work with variants on this minimal medical impact appliance, using the PoNS™     device to augment therapy may result in a significant improvement in VR outcomes. Given the     enormous public health and military burden of mTBI, and given that dizziness is a major     component often responsible for significant morbidity, this project has significant military     and civilian impact and can be beneficial to those who suffer mTBI worldwide.   "
115690|NCT01771562|"     The advent of highly active antiretroviral treatment has resulted in the survival into     adolescence of an increasing proportion of infants and children with perinatal HIV infection     in Senegal. However, the transformation of HIV into a chronic disease needing lifelong     antiretroviral treatment (ART) raises new challenges, among others related to a disturbance     of glucose metabolism, lipid abnormalities, in addition to the potential effects on     children's growth and puberty. Little is known on nutritional and metabolic changes in     HIV-infected children on ART in Africa, while implementation of the latest WHO     recommendations should eventually lead to an increase in the number of children on ART in     this region. Moreover, bio-clinical evolution of untreated children is poorly documented in     the African context. It therefore urgently needed to institute a cohort study to evaluate, in     the long term, the impact of HIV infection and/or ART on nutritional and metabolic disorders     and to characterize the risk factors of their occurrence in children and adolescents infected     as they move through adolescent into adulthood.   "
115691|NCT01771549|"     This pilot study involves very frequent monitoring of breast cancer patient blood levels of     hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of     chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both     biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are     frequently elevated after experimental chemotherapy in animal models. Their behavior in     humans has been inconsistent, with occasional elevations seen, usually within 30 days of     therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced.     A majority of patients greater than age 50 have elevations above the detection limit,     compared to only 1-3% with conventional troponin assays, and over 90% of diabetics have     elevations above the detection limit. Moreover, augmented release of high sensitivity     troponin is detected after exercise or rapid atrial pacing of durations of 10-15 minutes in     patients with and without coronary artery disease. This improved sensitivity suggests the     potential for detection and monitoring of cardiac damage after cancer chemotherapy. We     hypothesized that this new generation of troponin assay would be associated with kinetic     behavior suggesting ongoing cardiac damage with anthracycline therapy, and possibly also with     trastuzumab.   "
115692|NCT01771536|"     Despite several large clinical trials clearly establishing that coronary revascularization     (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent     myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable     angina continue to believe that PCI is performed to improve these outcomes. Additionally,     recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus     there is a compelling need to share with patients the risks and benefits of PCI prior to     treatment to reach an informed decision.      This study is designed to answer the question of whether a decision aid can improve patient     knowledge, decisional conflict and patient satisfaction with decision-making compared to     usual care for the treatment of stable angina.   "
115693|NCT01771523|"     Background : The use of suction drains in thyroid surgery is common practice in order to     avoid haematoma or seroma, as well as to identify promptly the onset of haemorrhaging that     might compromise the patient's airway. The aim of this study to determine the effects of     routine drainage compared to no drainage in thyroidectomy patients.      Study Design : Total of 400 patients who undergoing total thyroidectomy or lobectomy for     thyroidal disorders will be randomly allocated to be drained or not. Postoperative     ultrasonographic (USG) neck examination will be performed for all patients on postoperative     24th hour by the same ultrasonologist each time. Postoperative pain, complications and     hospital stay will be recorded. The statistical analysis will be performed and p<0,05 will be     accepted as an important statistical value (SPSS 16.0 for Windows).   "
115694|NCT01771497|"     The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment     of breast cancer will allow for accurate tumor localization and tumor volume measurement,     leading to improved surgical and radiation therapy outcomes.   "
115695|NCT01771484|"     The investigators will test to determine if an external Automated Abdominal Binder     (non-commercial product) during high sodium diet improves orthostatic tolerance, compared to     wearing the binder during a low sodium diet session.   "
115697|NCT01771458|"     SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies     for patients with refractory cancer.      From a tumor biopsy, a molecular profile of the disease is established (mutations,     amplifications, hormone receptor status). If a molecular abnormality is identified for which     an approved targeted agent is available, patients are randomized randomized between two arms:        -  Targeted therapy based on the molecular profile        -  Conventional therapy based on investigator's choice.      A cross-over is proposed at disease progression.   "
117917|NCT01742494|"     Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to     laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical     modifications have been proposed but have not yet been tested in randomized trials.   "
115698|NCT01771445|"     Aim: Evaluate the regulation of muscle derived Interleukin-6 (IL-6)during exercise and in     particular whether it is regulated by the Interleukin-1 (IL-1) system.      Rationale: It has been shown that IL-1 antagonism improves glycemia and insulin secretion in     patients with type 2 Diabetes. However, IL-1 antagonism also decreases IL-6 levels. The     effect if IL-6 on the glucose metabolism has been unclear in the past and subject to intense     debate, with recent evidence indicating a beneficial role in regulating glucose metabolism.     However little is known about regulation of muscle-induced IL-6 produced during exercise. It     is therefore our aim to investigate whether exercise induced increases in IL-6 are dependent     on the IL-1 system. If IL-1 antagonism does decrease IL-6 and along with it, the beneficial     potential of IL-6, this may require additional medication like IL-6 substitution or     dipeptidyl peptidase-IV (DPP-IV)antagonists.      In addition, the investigators will assess the effect of IL-1 antagonism on insulin and     Glucagon like peptide-1 (GLP-1) secretion as well as muscle soreness,fatigue and vascular     function in response to an acute exercise bout.   "
115699|NCT01771432|"     Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney     transplant recipients could be useful to prevent pyelonephritis in these patients.   "
115700|NCT01771419|"     Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be     associated with fewer complications and post-ERCP (Endoscopic retrograde     cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access     with cannulotome (CT-25 Cook Medical) with contrast injection even if results are     conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in     the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.   "
115701|NCT01771406|"     The aim of this study is to examine how effective CPAP treatment and treatment with nebivolol     are respectively on reducing blood pressure and on endothelial dysfunction in patients     suffering from obstructive sleep apnea and hypertension.   "
115702|NCT01771393|"     ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging.     Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for     an analysis of the limbs distal joints. Our hypothesis is that the cone-beam scanner could     detect and characterize chondral lesions the cartilage similarly to a multidetector CT     (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee     will be enrolled The primary endpoint based on the ability of cone-beam scanner to detect     cartilage lesions. Secondary endpoints will concern the depiction of the joint lesions,     quality of the images, tolerability of the exams and inter- intra-operator reproducibility.     After arthrography, patients will have a MDCT considered as the reference exam, and a CBCT on     a randomized order. Exams will be anonymized and read twice by two trained radiologists with     3-6 week intervals. The inter-observer agreement for the diagnosis of cartilage lesion type     between the two techniques will be evaluated by a kappa coefficient. The evaluation of     diagnostic performance will be achieved by studying the sensitivity, specificity, negative     predictive value and positive predictive value, and its likelihood ratio. Kappa test will be     performed to evaluate the consistency of the depiction of the lesions. A Student t test will     be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess     patient's tolerance, the percentages of (painful, not painful) will be calculated for each     technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not     apply).   "
115703|NCT01771380|"     In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein     (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free     fraction that is biologically active. Polymorphisms in DBP are related to the serum level of     25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the total     serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we will     calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and also     measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we will     relate total serum 25(OH)D as well as the free and biologically active (free- albumin-bound)     25(OH)D to the well established vitamin D effect marker serum parathyroid hormone as well as     to the RNA expression in peripheral blood to evaluate the biological importance of the free     versus the total fraction of 25(OH)D. We will invite 300 subjects from an ongoing vitamin D     supplementation study to participate in the study which will be one visit only and include     collection of blood samples.   "
115704|NCT01771367|"     It is thought that vaccines trigger innate inflammatory responses to induce antigen-specific     adaptive immunity (the desired effect), but excessive inflammation may lead to serious     inflammatory complications or unwanted side effects. Currently there is a lack of reliable     biomarkers (a measurable biological response that predicts something) able to predict severe     inflammation and this has resulted in the development of several vaccines being terminated     and the withdrawal of some licensed vaccines which were associated with inflammatory     complications.      This study is part of the BIOVACSAFE project which is a 5-year 30 million Euro project funded     by the Innovative Medicines Initiative. The project involves a series of clinical studies     using licensed vaccines as benchmarks to generate clinical data on inflammation and identify     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify     biomarkers that can predict the occurrence of beneficial and detrimental effects in response     to a vaccine. Such biomarkers could be used in future vaccine development programs to     optimise selection of vaccine candidates with a profile that will be unlikely to generate     worrisome safety signals once they are in generalised use.      This study is one in a series of training studies which will each use different licensed     vaccines that are prototypical representatives of a class of vaccine used in a particular     population. Forty-eight subjects will be randomised into three groups to receive: a) Fluad     (n=20), b) Agrippal (n=20), c) saline placebo (n=8). Following a screening visit,     participants will undergo a seven-day residential visit which will include immunisation and     intensive monitoring of physiological (e.g. heart rate, oral temperature, blood pressure)     metabolic and immune (innate and adaptive) parameters. This visit will be followed up by four     outpatient visits with further monitoring and blood samples.   "
115715|NCT01771224|"     Introduction: Inflammatory bowel disease (IBD) refers to two chronic diseases that cause     intestinal inflammation, ulcerative colitis (UC) and Crohn's disease (CD). The conventional     treatment is not effective; therefore, alternative therapies may be effective specially in UC     patients. Fatty acid (FA) may have a beneficial effect on some UC patients. The increasing     incidence and prevalence of UC and ineffective treatments in some patients, allows search     coadjuvant therapies. Objective: Quantification of differences between patients with and     without FA. Methods: In two groups of patients with UC is administered FA and placebo. We     will measure the changes clinical, endoscopic and histological in both groups, before and     after treatment.   "
115716|NCT01771211|"     The purpose of this study is to determine if non-invasive electrical brain stimulation can     improve word-retrieval in Mild Cognitive Impairment (MCI).   "
115705|NCT01771354|"     It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific     adaptive immunity (the desired effect), but excessive inflammation may lead to serious     inflammatory complications or unwanted side effects. Currently there is a lack of reliable     biomarkers (a measurable biological response that predicts something) able to predict severe     inflammation and this has resulted in the development of several vaccines being terminated     and the withdrawal of some licensed vaccines which were associated with inflammatory     complications.      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the     Innovative Medicine Initiative. The project involves a series of clinical studies using     licensed vaccines as benchmarks to generate clinical data on inflammation and identify     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify     biomarkers that can predict the occurrence of beneficial and detrimental effects in response     to a vaccine. Such biomarkers could be used in future vaccine development programs to     optimize selection of vaccine candidates with a profile that will be unlikely to generate     worrisome safety signals once they are in generalized use.      This study is one in a series of training studies which will each use different licensed     vaccines that are prototypical representatives of a class of vaccine used in a particular     target population. Twenty four subjects will be randomised into two groups to receive: A)     Engerix B vaccine (n = 20), B) Saline placebo (n = 4). Following a screening visit,     participants will undergo two immunisations at month 0 and month 6. Each immunisation will     occur during a seven day residential visit which will include immunization and intensive     monitoring of physiological (e.g. heart rate, oral temperature, blood pressure) metabolic and     immune (innate and adaptive) parameters. Both residential visits will be followed up by four     outpatient visits with further monitoring and blood samples.   "
115706|NCT01771341|"     Neurally adjusted ventilatory support improved synchronization in the medical patient.     However no data are available in the postoperative patient.      This way the investigators designed a prospective randomized cross over trial to evaluate     this issue in the abdominal post-operative patient.   "
115707|NCT01771328|"     The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH)     renders the cortisol levels unphysiological, which may cause symptoms and long-term     complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous     hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method     was recently applied to treat a patient through a critical phase of puberty. This is a     clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is     to determine the effects of CSHI on metabolic parameters (androstenedione and     17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH),     cortisol, and bone markers), and to determine the required glucocorticoid doses. Secondary     objectives are to determine effects on clinical status, body weight, blood pressure and other     metabolic parameters, as well as on subjective health status (AddiQoL, SF36).   "
115708|NCT01771315|"     The aim of this study is to determine the effect of nurse led follow-up following total knee     arthroplasty in regard to physical function, health related quality of life and     self-efficacy.   "
115709|NCT01771302|"     This randomized clinical study investigates the efficiency of plasma rich in growth factors     (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after     the performance of lateral sinus floor elevation.      The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone     formation regardless the type of bone graft.   "
115710|NCT01771289|"     The purpose of this study was to evaluate the safety and efficacy of neoadjuvant concurrent     chemoradiation with weekly docetaxel/cisplatin in patients with resectable IIIA-N2 NSCLC.   "
115711|NCT01771276|"     The purpose of this study is to help find out more about how the Primary Obesity Surgery     Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to     weight loss. In this study, USGI Medical wants to see if stomach emptying and     gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared     to typical) number of anchors placed.   "
115735|NCT01770964|"     The difference between active treatment and placebo in a clinical trial of an analgesic     appears to depend on a variety of factors other than the actual efficacy of the drug itself,     including various aspects of study design and conduct. One potential such factor is how     information about the study is presented to research staff and patients. The purpose of this     study is to examine the impact of different presentations of information on the difference     between pregabalin and placebo observed in a clinical trial in patients with painful diabetic     neuropathy.   "
115736|NCT01770951|"     The objective of this retrospective trial is to assess safety and efficacy of eculizumab in     aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.   "
115819|NCT01769872|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with     spinal cord injury   "
115712|NCT01771263|"     In closed-loop controlled anesthesia, feedback from a measure of the clinical effect is used     to continuously adjust drug infusion rates. Anesthetic drugs are delivered at a variable rate     that is personalized to the individual patient. The aim is to provide greater hemodynamic and     respiratory stability, more stable depth of anesthesia, the ability to predict recovery and     to administer a lower total dose of drug. Previous work in closed-loop control of intravenous     anesthesia has focused on the titration of propofol in response to a depth of hypnosis (DOH)     measure derived from the electroencephalogram (EEG).      The purpose of this pilot study is to evaluate iControl-RP, a system, which performs     controlled delivery of both remifentanil and propofol infusions. iControl-RP allows either     drug to be operated in any of 3 modes: closed-loop control based on feedback from an EEG     measure supplied by NeuroSENSE (1); target-controlled infusion (TCI), based on     previously-described pharmacokinetic (PK) and pharmacodynamic (PD) models; and conventional     manual infusion, which require a weight-based dose setting.      A pilot two-phase study will be undertaken in a group of adult patients under the direct and     immediate supervision of an experienced anesthesiologist. In Phase 1 (involving 50 study     subjects), propofol will be administered in closed-loop mode and a remifentanil infusion will     be administered based on a TCI. The data collected in this phase will be used to tune the     controller parameters, which are initially based on previously published PKPD data. The     controller performance will then be evaluated in phase 2 (involving 100 study subjects), in     which both propofol and remifentanil will be administered in closed loop mode. In both     phases, cases will be selected from those receiving propofol and remifentanil as anesthetic     agents for routine surgical procedures.      The investigators aim to demonstrate that closed-loop control of anesthesia and analgesia     based on EEG feedback is clinically feasible. This pilot study will help us take a     significant step towards a controlled trial in which the clinical benefit of this method of     closed-loop control of anesthesia can be assessed.   "
115713|NCT01771250|"     This study has two parts. Each participant will receive a daily injection of LY2605541 during     one treatment period and a daily injection of insulin glargine during the other treatment     period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how     the body uses or stores fats while taking each study drug.   "
115714|NCT01771237|"     This exploratory study aims to design and test an HIV prevention intervention for young men     who have sex with men (MSM) between the ages of 16-20 as this group comprises the US     adolescent population most at-risk for HIV infection through sexual contact. To help develop     the content and format of our intervention we will first conduct in-depth interviews with     twenty-one 18 to 24 year-old young MSM who acquired HIV through male-to-male sexual contact     between ages 16-20 (i.e., the target age of our intended intervention). We will then design a     group-based primary intervention for young MSM between ages 16-20, relying on the information     we gathered from these interviews, as well as consultation from an advisory board of young     MSM and HIV prevention experts. Last, we will use an experimental design to compare our     intervention to a control condition. We hypothesize that, relative to a control condition of     sexual health education and risk reduction, participants in our intervention will demonstrate     lower rates of HIV risk behavior, find participation more feasible, and endorse greater     acceptability of our intervention.   "
115717|NCT01771198|"     The purpose of this study is to investigate the clinical efficacy of oral treatment with a     statin, SIMVASTATIN 40mg, in a target population of patients with severe chronic     rhinosinusitis resistant to surgery followed by conventional medical and surgical treatment.   "
117953|NCT01742026|"     ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION   "
115718|NCT01771185|"     Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes     therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose     homeostasis occurs within days after surgery before significant weight loss is achieved. This     observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has     specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical     and endoscopic procedures that bypass the upper GI tract are currently being studied in human     subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has     been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS     results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects     will undergo metabolic studies at the University Hospital in Sao Paulo before and after their     surgical procedure. Washington University investigators will: 1) provide technical support     and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood     samples obtained from the study at the Washington University Center for Human Nutrition, and     3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS     on the following clinical and metabolic parameters will be evaluated   "
115719|NCT01771172|"     To assess the defibrillation efficacy of a subcutaneous defibrillation system.   "
115720|NCT01771159|"     Spinal Cord Injured [SCI] patients typically cannot pee. Injury to the spinal cord disrupts     the in-coming and out-going brain signals that coordinate bladder sensation and the emptying     of bladder. SCI typically causes chronic retention of urine with uncontrolled leakage of     urine. Some form of tube (catheter) is needed to drain the urine except with the mildest     forms of SCI. Two types of tubes to drain the urine have been used for many years. These     types are the urethral (inserted into the bladder through the opening usually used to empty     the bladder) and abdominal, called suprapubic cystostomy tubes (put into the bladder through     the abdomen).      Bacteria (germs) normally live on our skin. Bacteria have sticky surfaces and so they stick     to catheter surfaces. Bacteria reproduce very rapidly from a few dozen to over a million in     24 hours. In a warm liquid environment, like urine, bacteria can reach a density of 10     million per cubic centimeter in 48 hours which causes infection. Oral drugs and     antibiotic-coated catheters delay this process by a week or two, but within a month 100% of     patients have bacteria in their urine. Existing drugs cannot eliminate these microbial     sanctuaries.      The TBC is a 'closed access' abdominal drainage tube that has a 'cuff' or 'anchor'. It is     permanently placed in the abdominal muscle to bond with the body's tissue. Another catheter     is temporarily connected to the TBC that is easily replaceable in the clinic without     anesthesia or special instruments. It locks to form a water-tight system. Many parts of the     TBC are coated with an antibacterial substance that will delay the growth of bacteria. The     TBC has been used with success in multiple animal studies.      This is a Phase I human clinical trial in which the TBC will be used 10 spinal cord injured     patients, each of whom will be followed for 12 months or longer. Abdominal catheter exit     sites will be photographed monthly and tested periodically to document growth of any     bacteria. Every three months, patients will complete satisfaction questionnaires and their     urine will be tested for bacteria. Urine will also be tested as clinically indicated.   "
115721|NCT01771146|"     A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic     pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)   "
115737|NCT01770938|"     Muscle performance is largely influenced by modulations in gene expressions of muscle tissue.     In this context, light-emitting diode therapy (LEDT) has been used to improve muscle     performance in experimental models and human researches. Thereby, the investigators examined     modulations in gene expression of muscle tissue as well as biochemical, biomechanic and     histologic adaptations influenced by exercise associated to LEDT.   "
115738|NCT01770925|"     non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to     compare between capap and n-bipap   "
132429|NCT01551589|"     This study examines contrast advantages and disadvantages of elective or prophylactic nodal     irradiation in the treatment of esophageal cancer with three-dimensional conformed     radiotherapy.   "
115722|NCT01771133|"     The investigators propose to conduct a randomized controlled trial in 200 overweight/obese     pregnant women and their offspring. The prenatal intervention will emphasize improving diet     and physical activity. The lifestyle intervention will be delivered within an empowerment     theoretical framework through a combination of group sessions, individual counseling, and by     monitoring compliance to diet and physical activity to further tailor the intervention. The     post-partum intervention sessions will include mothers and their offspring and will focus on     breastfeeding, improving physical activity and quality of the diet and feeding practices     through the first post-partum year. As part of routine prenatal care, participants in both     the control and intervention arms will be given health-related advice. Since the majority of     participants are expected to be eligible for the Women, Infants and Children (WIC) program,     both groups will also receive assistance through WIC as per their routine policies. Our     primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is     infant BMI z-score at 12 months of age, and the investigators will also be evaluating several     metabolic outcomes in mothers and infants.   "
115723|NCT01771120|"     An observational cross-sectional study will include 750 individuals of all ages, divided in 4     groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with     a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported     diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory     symptoms or diseases (n=300)   "
115724|NCT01771107|"     This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin     when given together with combination chemotherapy and to see how well they work in treating     patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma.     Monoclonal antibodies, such as brentuximab vedotin, may block cancer growth in different ways     by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride,     vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more     cancer cells.   "
115725|NCT01771094|"     The purpose of this study is to determine if water and diet soft drinks with different levels     of sweeteners have the same effect on thirst.   "
115726|NCT01771081|"     POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with     central involvement to assess the effectiveness of existing anti-vascular endothelial growth     factor (anti-VEGF) treatment regimens.   "
115727|NCT01771068|"     The present study aims to examine the effectiveness of a parenting intervention, the Triple P     Positive Parenting Program Level 3 discussion groups dealing with disobedience. Triple P is     a system of interventions to support families and was developed at the University of     Queensland in Australia in the 1980's. As few studies have tested the effectiveness of     parenting programs in developing countries, the present study took place in a developing     country, Panama.      In a recent study carried out in Australia, this same intervention was found effective in     reducing child behaviour problems and the use of dysfunctional parenting (Morawska, Haslam,     Milne & Sanders, 2011).   "
115728|NCT01771055|"     The purpose of this study is to find if direct peritoneal resuscitation helps blood flow     through important organs in a person's body after they have had a traumatic injury with     massive blood loss. Sometimes after severe injuries requiring operation, surgeons cannot     close the muscles and skin of a patient's belly, because of swelling. This study will also     try to find if direct peritoneal resuscitation decreases tissue swelling and allows for     quicker closure of of a patient's belly.   "
115729|NCT01771042|"     Elevated subconscious nervous system activity is a characteristic of the obese state and     contributes importantly to the risk of heart disease and diabetes. This project will compare     sympathetic nervous system activity and function in a group of obese persons with differing     levels of sugar tolerance (normal, impaired and type 2 diabetic). Inter-relationships with     insulin action, blood pressure, heart and kidney function will be determined before and after     a 4-month weight loss and 3-month weight loss maintenance program.      It is hypothesized that the transition from normal sugar tolerance to impaired sugar     tolerance to type 2 diabetes will be accompanied by escalating sympathetic nervous system     dysfunction. Furthermore, that weight loss will favorably improve sympathetic function, with     greatest benefits occurring in those subjects who are insulin resistant with high blood     insulin concentration.   "
115730|NCT01771029|"     Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under     routine conditions with native patient samples. The clinical validation is planned as a     method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT).     The study hypothesis is to show a highest correlation between the new product and the     reference methods.   "
115731|NCT01771016|"     Retrospective analysis of requests of emergency hormonal contraception using pharmacy     protocols registered in 2003 and 2006.   "
115732|NCT01771003|"     Partial Nephrectomy has become the standard treatment in patients with tumours <7cm (T1).     Even though this is a nephron sparing surgery, there is still potential for acute kidney     injury, due to ischemia during the surgery. Remote Ischemia Preconditioning may prevent acute     kidney injury and in turn chronic kidney disease. Remote Ischemia pre-conditioning involves     applying a blood pressure cuff and inflating and deflating several times immediately prior to     surgery.   "
115733|NCT01770990|"     This study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT)     interventions for patients with mild to moderate depression. Both interventions consist of     one personal session and weekly to bi-weekly 8-10 telephone sessions with a licensed     cognitive-behavioral psychotherapist accompanied by the study of educational materials and     the completion of regular monitoring questionnaires (total treatment duration: approximately     3 months). Patients are randomized into one of two conditions: Patients in the condition     Tel-PT including mail additionally receive a motivating letter from their psychotherapist     after each telephone session, while patients in the condition Tel-PT without mail receive     no further interventions. Patients refusing to be randomized are to be assigned to the     condition Tel-PT without mail. This study takes place within a larger study evaluating a     stepped care model for depression (01KQ1002B-TP7).   "
132430|NCT01551576|"     The purpose of our study is to image human prostate tissue using a transrectal photoacoustic     imaging probe.   "
115739|NCT01770912|"     The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid     injection is more efficacious than a placebo injection based on standard pain and physical     measures that are recorded before and after treatment.      All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical     care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing     followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this     is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc     (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A     pregnancy test (urine test) will be conducted on all women of child-bearing age to verify     that the patient is not pregnant before the rinsing procedure. The patient will fill out a     short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.   "
115740|NCT01770899|"     The purpose of this study is to evaluate the effectiveness of oral montelukast (Singulair)     given with other standard asthma medications and treatments in the treatment of children with     status asthmaticus. Status asthmaticus is an acute asthma attack that does not respond to     standard intermittent treatments but requires a continuous medication to aid in breathing.     While new medications have been used to better manage chronic asthma, acute asthma     exacerbations continue to be a significant cause of hospitalization and even death in     children. Oral montelukast is a very safe medication that is used to manage chronic asthma in     children, but it has not been studied for use in status asthmaticus. If oral montelukast,     given with other standard therapies, can reduce the treatment length associated with severe,     acute asthma exacerbations in children, it could potentially improve both the morbidity and     burden of pediatric asthma.   "
115741|NCT01770886|"     A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety,     pharmacokinetic and pharmacodynamic data will be collected.   "
115742|NCT01770873|"     The purpose of this study is to test whether a violence prevention curriculum delivered by     Big Brothers and Big Sisters staff and mentors can reduce violence involvement for     assault-injured youth.   "
117967|NCT01741844|"     The purpose of this study is to assess the safety data of etravirine in a natural clinical     practice.   "
115743|NCT01770860|"     This two-week study will compare the healing of minor wounds when no bandage is applied     against four different types of bandages.      The study investigators will make five small wounds similar to scrapes (about a half-inch     square) on the back of subjects who qualify to participate in the trial and have given     informed consent. Four of the wounds will be covered by different bandages and one will be     left uncovered. Participants will visit the clinic every day for 2 weeks or until all the     wounds are healed (whichever comes first). At the clinic, the bandages will be removed, the     doctor will score the wounds, a picture will be taken of the wounds and new bandages will be     applied.      It is expected that some pain and itching will be experienced, because they are part of the     normal wound healing process. Subjects will be asked about adverse events at each visit and     will have the opportunity to discuss issues or concerns with the investigator or the doctor     during the course of the trial. It is expected that the wounds will be completely healed     within 14 days, but if not, the participant will need to return to the clinic for follow-up     treatment until the wounds are completely healed.      We will see if the different bandages help with the healing of the wounds during the study.   "
115744|NCT01770847|"     Diurnal variations in the cardiovascular system apparent in healthy individuals, are     different in chronic kidney disease patients. Therefore, diurnal variations in arterial     stiffness may also differ in chronic kidney disease patients. This study aims to identify and     evaluate diurnal variations in arterial stiffness in chronic kidney disease patients and     compare them to those in age matched healthy controls.   "
115745|NCT01770834|"     This prospective, observational study will evaluate the efficacy, safety and tolerability of     RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid     arthritis who have had an inadequate response or are intolerant to one or more conventional     disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on     RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and     at 3 and 6 months after the last dose of study drug.   "
115746|NCT01770821|"     Patients with critical illness loose bodymass, mainly muscle. The purpose of the present     study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich)     have effect on the six minutes walking test (6MWT), muscle strength, body weight, body     composition and quality of life after intensive care. This is a single center randomised     controled study comprising patients ≥45 years of age staying 5 days or more in the intensive     care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving     the ICU.   "
115747|NCT01770808|"     Digestive discomfort includes gastrointestinal symptoms such as abdominal pain, altered bowel     habit, flatulence and bloating and can sometimes result from slower intestinal transit and     other digestive irregularities.      The objective of this study is to investigate the effect of consuming Aquamin (as AquaCal and     AquaPT) on digestive discomfort and symptoms amongst adults without diagnosed     gastrointestinal disorders.   "
115748|NCT01770795|"     To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated     paclitaxel)and gemcitabine in untreated metastatic NSCLC patients   "
115749|NCT01770782|"     The objective of this study was to evaluate the effect of the orthodontic retainer on     transverse maxillary dental and skeletal stability after SARME.   "
115763|NCT01770600|"     This study is dedicated to achieving a better understanding of how the brain processes     information. Specifically, the investigators are studying cognitive function, thought     process, and impulsivity in people with and without suicidal thoughts. You are being asked to     participate in a research study to learn how the use of a medication, risperidone, improves     your symptoms of depression. Specifically the investigators are studying the effectiveness of     reducing the thought of suicide and other symptoms of severe depression. Risperidone is     approved by FDA for the treatment of schizophrenia and bipolar mania, and clinical practice     suggests that it might benefit patients with major depressive disorder. During clinical     trials with 2607 patients, risperidone was proved to be safe. This is a pilot study to test a     new indication of risperidone for treatment of severe depression. The study medication will     be given in addition to usual psychiatric care.   "
115750|NCT01770769|"     Clinical research during the last ten years has revealed that elderly patients with a     displaced femoral neck fracture should be treated with arthroplasty instead of closed     reduction of the fracture followed by internal fixation with pins or screws. Few clinical     trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These     fractures have been associated with a good prognosis and likewise a good functional outcome.     However, recent articles present far less favorable results, with high re-operation rates     (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing     studies, suggest that hemiarthroplasty may yield better functional outcomes and lower     re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years     or older are minimally displaced or undisplaced. Hence the investigators call for a     randomised controlled trial comparing pain, function, walking ability, quality of life,     re-operation rates and complications after internal fixation versus hemiarthroplasty in     patients aged 70 years and older.   "
115751|NCT01770756|"     The purpose of this study is to compare the effectiveness of two forms of self-care training     on the overall health of adults with hypertension.   "
115752|NCT01770743|"     The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine.     The vaccine schedule and dose will also be assessed.   "
115753|NCT01770730|"     The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB     diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with     increasing illness severity and more advanced immunosuppression, thus offering the greatest     potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4     cell count less than 200). However, in the context of high rates of empiric treatment and the     availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test     is unknown. This study will investigate the impact of the urine LAM strip test. The study     hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics     (smear microscopy and culture) will significantly improve TB treatment-related outcomes     (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized     patients when compared to standard TB diagnostics alone.   "
115754|NCT01770717|"     Pressure ulcers are a significant problem in institutionalized, elderly, and critically ill     patients. Pressure ulcers result in significant pain, changing quality of life, and often     leading to significant morbidity and prolonged hospital stays, and ultimately increased the     healthcare cost.      According to the International Pressure Ulcer Prevalence Survey, the prevalence of hospital     acquired pressure ulcers in the United States was 13.5% in 2008 and 12.8% in 2009. This     survey also indicated that the highest rate of pressure ulcers is in the long term acute care     population (22%).   "
115755|NCT01770704|"     The objective of the ambispective cohort study is to describe clinical management and     clinical outcomes related to bipolar disorder in China, and establish the factors associated     with different management patterns and clinical outcomes, provide psychiatrists with reliable     and up-to-date information on the disease.   "
117968|NCT01741831|"     The purpose of this study is to assess the safety data of darunavir in a natural clinical     practice.   "
115756|NCT01770691|"     Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss     of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running,     lifting or walking. SUI cause women to avoid routine physical activities, thus detracting     significantly from their quality of life.      The purpose of this study is to evaluate the performance of new designs of the TIPI device, a     conservative, disposable, treatment for temporary management of SUI.   "
115757|NCT01770678|"     Cerebral palsy remains a major cause of lifelong disability affecting approximately 2 per     1,000 children. Of those about 30% have hemiplegic cerebral palsy (HPC),a unilateral     impairment, which can often lead to major difficulties with manual dexterity and upper     limb,functional ability and independence. Therapists employ a number of strategies in upper     limb rehabilitation however they are poorly understood and their efficacy has been     questioned. Constraint induced movement therapy (CIMT)has been found to be an effective     intervention with HCP however its use in the preschool child within a national health service     (NHS) setting has not been evaluated. The investigators aim is to compare CIMT using     prolonged restraint with CIMT using brief manual restraint which may be standard practice and     acts as the control. This age group has been targeted as there may be greatest neural     plasticity (change)and minimal disruption to compulsory education. The investigators intend     to recruit 60 patients from treatment databases of participating trusts. Patients will be     randomised following baseline assessments which will include 2 upper limb assessments(The     Assisting Hand Assessment and the Quality of Upper Extremity Skills Test) and a quality of     life questionnaire (PedsQL Generic Core Scales and the Cerebral Palsy Module) for parents.     The intervention period will be for 6 weeks offered intermittently (2week blocks) over 10     weeks. Parents /guardians and possibly preschool workers will be expected to carry out a     therapy guided programme. The amount of intervention and compliance will be recorded by     parents/guardians and therapists. Assessments will be repeated at 10 weeks and 24 weeks from     the beginning of the trial. The results of the trial will contribute to the evidence on the     effectiveness of CIMT in the preschool child with HCP, and will also provide evidence on the     implementation of CIMT delivery within the current NHS therapy services.   "
115758|NCT01770665|"     Testing Mayo Clinic cancer patients with the results being correlated with prior patient     therapy, performance status, and extent of disease.   "
115759|NCT01770652|"     Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the     effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite     following a single oral dose of 33mg/kg Ferriprox®.   "
115760|NCT01770639|"     The aim of this study is to investigate the clinical outcomes of surgical correction of foot     deformity with the MFB in a larger group of patients with neurological impairment of the     foot.   "
115761|NCT01770626|"     The study is designed to evaluate how the composition of a participant's body, diagnosed with     a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis can     predict the progression and outcomes of disease.   "
115762|NCT01770613|"     The purpose of this study is to assess the safety and tolerability of human allogeneic     mesenchymal bone marrow cells (aMBMC) administered intravenously to subjects with ST Segment     Elevation Myocardial Infarction (STEMI).   "
115764|NCT01770587|"     An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal     ideation.   "
115840|NCT01769599|"     there is no yet agreement about the best way to treat Diabetic Macular Edema (DME) the two     options up to day are using Grid laser treatment Vs. Avastin injections or a combination of     both in this study we want to compare the two attitudes.   "
115765|NCT01770574|"     The purpose of this study is to determine whether structural calcium ceramic bone graft     substitute (ReproBone™) is non-inferior compared to autologous tricortical iliac crest bone     graft in lateral calcaneal lengthening osteotomies in pediatric patients and reduces     postoperative pain.      To groups of patients (age 5-16) will be compared. One group randomized to autologous bone     graft and the other group randomized to calcium ceramic.      The evaluation will be based on radiostereometric analysis, pedobarography, Patient reported     outcome assessment (Oxford Ankle Foot Questionnaire), and pain (measured by visual analog     scale and numerical range scale).   "
115766|NCT01770561|"     The purpose of this study is to collect performance data on the integrated sensor and     infusion set during 3 days of use and demonstrate performance adequacy of the Integrated     sensor and infusion set with glucose sensing and insulin delivery functionalities. The     hypothesis of this study is that having the infusion of insulin in close proximity to the     sensor does not interfere with the sensor accuracy.   "
115767|NCT01770548|"     Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism   "
115768|NCT01770535|"     The purpose of the study is to understand why there are differences between individuals in     the way they respond to paclitaxel chemotherapy.   "
115769|NCT01770522|"     It is well known that being overweight or obese increases the risk of health problems, and     that many people find it difficult to maintain a healthy weight. Worryingly the rise in     obesity is greater in women than in the male population. One possible reason for this is that     some women gain too much weight during their pregnancy and find it difficult to lose this     weight after the birth of their baby. For example, women who gain more weight than     recommended during pregnancy have been shown to be more likely to carry excess that weight at     1 and 15 years after pregnancy, compared to women who gained the recommended amount of     weight.      There are currently no evidence-based guidelines in the UK for how weight should be managed     during pregnancy. For these reasons, it is really important that we understand the factors     affecting weight management before, during and after pregnancy.      The aim of this research is therefore to find successful approaches to help women manage     their weight before, during and after pregnancy. This will be completed by understanding the     knowledge, attitudes, experiences and expectations of women during and after pregnancy and to     identify the factors (e.g. diet, physical activity, poor social network etc.) which influence     body weight. This will enable us to suggest better strategies for promoting healthy weight     changes during and after pregnancy.   "
115770|NCT01770509|"     Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are     common in patients older than 65 years and cause a significant morbidity.      Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix     of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural     Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of     venous stasis and post-erysipelas leg ulcers.   "
115771|NCT01770496|"     The objective of this study was to assess the relative effectiveness of reminder/recall     strategies among children who live in an urban area targeting alternative age-specific     milestones.   "
115772|NCT01770483|"     The purpose of this study is to investigate if nitazoxanide used in combination with     interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic     patients by improving their sustained viral response by more than 80%.Considering that the     study is being conducted in a third world country like Pakistan, the standard treatment of     hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in     efficacy to peginterferon and also cost effective.   "
115773|NCT01770470|"     The purpose of the pilot study is to determine the impact of short-term administration of     chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate     levels.   "
115774|NCT01770457|"     This study is designed to examine the early sequential cytokine responses during antibiotic     therapy and resuscitation of septic shock in relation to clinical manifestations of disease.      The specific objective is to obtain sequential serum samples from patients with septic shock,     examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a     rigorous manner and correlate these responses to administration of antibiotics, resuscitative     efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).   "
115775|NCT01770444|"     This study is to see whether the low-dose coronary computed tomographic angiography (CCTA)     protocol is as safe and efficacious as conventional-dose protocol in early triage of acute     chest pain.   "
115776|NCT01770431|"     To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and     metastasis of hepatocarcinoma after radical hepatectomy.   "
115777|NCT01770418|"     The purpose of this research study is to compare the effects (good and bad) on subjects and     their cancer using standard chemotherapy in combination with hypofractionated proton     radiation therapy. Hypofractionation is a technique that delivers higher daily doses of     radiation over a shorter period of time.   "
115778|NCT01770405|"     This study focuses on four different lesions: pancreatic cysts, lymph nodes near the     gastrointestinal tract, pancreatic masses and GIST tumors.      On one hand, the results obtained during previous studies are more advanced for the     assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser     Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have     already been performed, and an interpretation criteria classification exists. On the other     hand, results for pancreatic masses, Lymph nodes and GIST are less developed.      the objectives of the study are to        -  Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser          Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas,          lymph nodes, submucosal lesions of the GI tract        -  Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of          the pancreas, lymph nodes, submucosal lesions of the GI tract   "
115779|NCT01770392|"     To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of     nintedanib   "
115780|NCT01770379|"     This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS)     for subcutaneous self-administration in patients with active rheumatoid arthritis who are     intolerant to or have had an inadequate response to anti-TNF-α agents.   "
115781|NCT01770366|"     Obesity affects over one-third of the US population, and is associated with serious medical     problems like diabetes and heart disease. Weight loss surgery is the most effective treatment     for obesity, but some weight loss surgery patients lose less weight than others, and some     patients regain the weight they lost. Researchers have found that support groups help     post-surgical patients lose more weight, but long-term support programs often aren't     available or are difficult for patients to get to. Physical activity is also important for     weight loss surgery patients, but most post-surgical support programs don't focus on helping     patients exercise. Our pilot study will test an Internet-based weight loss surgery support     program that patients can use from home, and will include new devices such as wireless weight     scales and wireless pedometers to help patients track their weight loss and physical activity     and share their progress with their clinicians over the Internet. If successful, our support     intervention will help more patients successfully lose weight after surgery, and therefore     will improve their long-term health.   "
115782|NCT01770353|"     This is a Phase I Pilot study to understand the biodistribution of MM-398 and to determine     the feasibility of using Ferumoxytol as a tumor imaging agent.   "
115783|NCT01770340|"     Earlier studies were able to show that an improvement of the erectile function following a     non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.      The investigators evaluate the use of the implantation of the allogenic nerve graft Avance®     in patients undergoing non nerve-sparing radical prostatectomy.   "
115784|NCT01770327|"     The purpose of this study is to determine if water and three different sugary beverages     (milk, Orange juice and iced tea) have the same effect on thirst.   "
115785|NCT01770314|"     The purpose of this project is to test whether an online pain medication intervention is a     feasible and effective way to increase opioid pain medication safety.   "
115804|NCT01770067|"     Following previous positive experience with CITA-RNPT of infected pacemakers, we suggest that     CITA-RNPT can be administered prophylactically to patients prior to replacement of CIED,     immun-compromised patients, and others.   "
115805|NCT01770054|"     A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in     Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the     metabolic syndrome in adults aged 40 years or more living in this rural village of coastal     Ecuador.   "
115806|NCT01770041|"     This observational study will assess the metabolic pathways of paracetamol that are utilised     after liver resection.   "
115786|NCT01770301|"     Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood     vessels (a process called angiogenesis). This can reduce blood flow of the tumor and then     decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the     tumor from growing.      In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the     bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already     benefits from a marketing authorization (MMA) for these various types of cancers.      The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most     frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication     demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is     ended.      This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal     since this tumors are very well vascularized.      The ALIENOR study aims to explore the interest and the clinical benefit of associating     bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords-     stromal tumor treated beforehand by platinum chemotherapy   "
115787|NCT01770288|"     During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces     high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is a     marker to the increased protons concentration and acidosis.nevertheless, the increased level     of protons in addition to the release of bradykinin causes pain during the exercise that     limited the subject's performance. Therefore, it is assumed that the individual pain     sensitivity might determine the subject's performance.      Aims: To investigate the role of the DNIC efficiency in prediction of anaerobic performance     in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain     during anaerobic exercise and its contribution to the subjects' performance (3) to assess the     function of pain-related psychological factors in anaerobic performance.   "
115788|NCT01770275|"     Background. The aim of our study was to investigate the ability of the Seventh edition of the     classification by the International Union Against Cancer (UICC) to identify patients at     higher risk and to predict the overall survival in patients with esophageal carcinoma.     Methods. Demographic and clinical data of 605 patients, who underwent esophagectomy for     esophageal carcinoma between 1992 and 2009, were analyzed. Tumor stage and grade were     classified according to the sixth and seventh editions of the UICC classification.   "
115789|NCT01770262|"     Lack in vitamin D reduces the absorption of calcium in the body, accelerates bone loss and     may increase the risk of fractures due to osteoporosis. An algorithm that will allow     immediate and non-invasive quantification of vitamin D levels will shorten the time of     diagnosis, reduce lab costs and prevent hazards or discomfort to the patient associated with     a blood test.      The goal of the study is therefore to develop a non-invasive method for quantifying vitamin D     levels in the body using spectroscopy.      40 subjects will be recruited: 20 hospitalized patients in the rehabilitation department,     diagnosed with osteoporosis and 20 healthy subjects. Spectroscopy will be used with visible     light on the subject's skin and middle infrared (MIR) on the blood sample to find correlation     with the chemical lab test results.   "
115790|NCT01770249|"     This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of     achalasia.   "
115791|NCT01770236|"     The purpose of this study is to compare postoperative pain control after minimally invasive     coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic     medicine injected in an area under the ribs) in the operating room and IV acetaminophen     (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon     pump attached to 2 small tubes near your procedure site that automatically delivers pain     medicine).   "
116137|NCT01764763|"     Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool     to accurately assess ascending aorta disease. To date, several studies have reported that EAS     is superior to TEE and surgical palpation   "
115793|NCT01770210|"     In western societies hypercholesterolemia is one of the major and independent factors that     predispose to cardiovascular disease and death from them. According to the clinical study     ATTICA, conducted during the years 2001-2002, in which randomized 1514 men and 1528 women,     rates of hypercholesterolemia observed in a sample of urban population was 39% for men and     37% women . The prevalence in the corresponding U.S. epidemiological study NIANES was 52% for     men and 49% women. The relationship between cholesterol, lipid-lowering therapy and risk of     cardiovascular disease appears to be quite clear in the secondary prevention trials, the 4S     (Scandinavian Simvastatin Survival Study), CARE (Cholesterol And Recurrent Events) and LIPID     (Long-term Intervention with Pravastatin in Ischemic Disease) which showed the benefits of     lowering LDL cholesterol in patients with coronary artery disease. Despite these remarkable     results, studies were secondary prevention as a major shortcoming, the lack of patients with     acute coronary events. This gap came to cover the study MIRACL (Myocardial Ischemia Reduction     with Aggressive Cholesterol Lowering). In MIRACL study , atorvastatin 80 mg was evaluated in     3,086 patients (atorvastatin n = 1.538, placebo n = 1.548), acute coronary syndrome     (myocardial infarction without Q-wave or unstable angina). Treatment was initiated during the     acute phase after hospital admission and lasted for a period of 16 weeks. Treatment with     atorvastatin 80 mg / day increased the latency of the combined primary endpoint, defined as     death from any cause, nonfatal myocardial infarction, resuscitated cardiac arrest, or angina     with objective evidence of myocardial ischemia requiring admission to hospital, indicating a     risk reduction of 16% (p = 0,048). This was mainly due to a 26% reduction in     re-hospitalization for angina with objective evidence of myocardial ischemia. The other     secondary endpoints were not statistically significant by themselves (total: placebo: 22.2%,     Atorvastatin: 22.4%).      Statins by reducing coronary syndromes, it appears that contribute to reducing the incidence     of cardiovascular diseases. This is exactly what was observed in 4S, in which the incidence     of chronic heart failure (CHF) during follow-up was 10.3% for those who received placebo and     8.3% in the simvastatin group, a finding which translates 19% reduction in heart failure (P     <0,015) nationwide with the appearance episode (event) CV.   "
115794|NCT01770197|"     The time window for intravenous recombinant tissue plasminogen activator treatment in     ischemic stroke patients has been extended to 4.5h. Little is known about intravenous     recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese     stroke patients. This exploratory study was to describe the feasibility and outcome of     treatment with intravenous recombinant tissue plasminogen activator in the expanded time     window, and to offer suggestions for future clinical work in China.   "
115807|NCT01770028|"     The primary aim of the proposed study is to determine whether lifestyle interventions to     prevent excessive gestational weight gain in overweight/obese pregnant women have positive     ripple effects on untreated partners in the home. We hypothesize that partners of pregnant     women randomized to the lifestyle intervention, relative to those of standard care, will have     greater weight losses through 12-months. Secondary aims examine partner improvements in     weight control behaviors, the home environment, and psychosocial parameters.   "
115795|NCT01770184|"     Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10     years which is in large part due to the cyclical relationship of chronic disease, poor     health, and mild stroke which has gone largely unnoticed in the United States.     Self-management intervention has been proven to be an effective intervention to increase     healthy behaviors, improve overall health status, decrease healthcare utilization/cost,     decrease depressive symptoms, and improve participation in people with a variety of chronic     conditions; however, it has never be used with individuals with mild stroke. The critical     next step and goal of this study is to evaluate if self-management intervention will improve     health outcomes for persons with mild stroke. The overall hypothesis of this study is that     self-management intervention will improve outcomes in the mild-stroke population.   "
115796|NCT01770171|"     Wright et al (Anticancer Res, 2000) reported the results of a retrospective study on 11     patients with advanced/recurrent endometrial cancers. All patients had multi-site disease and     were heavily pretreated with a median of 3 prior chemotherapy regimens. All received     bevacizumab combination therapy which was well-tolerated. Two patients had partial responses,     3 had stable disease, while 5 patients progressed. One subject was not assessable for     response. The median progression-free interval was 5.4 months for the entire cohort and 8.7     months for those who achieved clinical benefit (PR or SD). The authors concluded that     Bevacizumab was well-tolerated and displayed promising anti-neoplastic activity in patients     with endometrial cancer.The rationale for combining anti-angiogenic agents, including     anti-VEGF antibodies, with cytotoxic chemotherapy stems from a number of preclinical studies     showing additive and synergistic anti-tumour activity in a number of solid tumour types. By     combining VEGF-targeting agents such as bevacizumab with conventional chemotherapies, it is     hoped that these agents will act synergistically, thereby enhancing their anti-tumour     efficacy and controlling disease progression.      The addition of bevacizumab to chemotherapy has been shown to improve PFS and/or OS in a     series of large, randomized Phase III clinical trials in a wide range of tumour types,     including mCRC, non-squamous NSCLC, metastatic BC (mBC) and mRCC.   "
115797|NCT01770158|"     This is a non-interventional multi-center study (NIS) in adult patients with AML in first     complete remission with measurable minimal residual disease (MRD). Patients are eligible when     gene status was already determined for previous induction and consolidation therapy of AML     and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to     observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and     interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to     monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first     complete remission. Therapy is administered for 10 treatment cycles as outlined in the     Summary of Product Characteristics.   "
115798|NCT01770145|"     This study is designed to assess the effect of APOKYN treatment in rapid and reliable     improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or     unreliable onset of levodopa (L-dopa) action.   "
115799|NCT01770132|"     This phase I trial studies the side effects and best dose of ultrasound-guided photodynamic     therapy with porfimer sodium when given together with gemcitabine hydrochloride in treating     patients with locally advanced pancreatic cancer. Photodynamic therapy uses a drug, porfimer     sodium, that becomes active when it is exposed to a certain kind of light. When the drug is     active, cancer cells are killed. Drugs used in chemotherapy, such as gemcitabine     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving photodynamic therapy together with     gemcitabine hydrochloride may be effect in patients with pancreatic cancer.   "
115800|NCT01770119|"     Measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed     children. Currently, measles vaccine is not recommended in pediatric orthotopic liver     transplant recipients, because it is a live-attenuated vaccine.      We want to assess the influence of immunosuppression on immunity against measles in     previously vaccinated children and to evaluate the induction of B cell and T cell response     against measles elicited by vaccination in children at least 12 months after transplantation.   "
115801|NCT01770106|"     The aim of this study is to compare the effects of denosumab and a current standard treatment     on cortical and trabecular microarchitecture at the radius and second metacarpal in     rheumatoid arthritis (RA) patients with low bone mineral density using high resolution     peripheral quantitative computed tomography (HR-pQCT) during a 6-month open-label randomized     controlled study. Forty ambulatory Chinese females, who consent to receive alendronate as     standard treatment subjective to the randomization, will be enrolled in this study. Subjects     will be randomized to 2 arms receiving: 1) subcutaneous injection of denosumab 60mg (Prolia®)     every 6 months (n=20), or 2) oral alendronate weekly (Fosamax® once weekly 70 mg, n=20). In     addition, all patients will be given a daily calcium supplement (1500mg caltrate /day) and 1     multivitamin tablet per day. Efficacy and safety assessment will be performed at baseline,     month 3 and month 6. aBMD of lumbar spine, total hip and non-dominant distal radius will be     measured using dual-energy X-ray absorptiometry (DXA) and microarchitecture of bone is     measured at the non-dominant distal radius and the second metacarpal bone of the non-dominant     hand using HR-pQCT.   "
115802|NCT01770093|"     Several studies have been conducted throughout the world to evaluate patients' and parents'     preferences regarding physicians' attire. Most studies have shown that the attire influences     their feelings trust and confidence regarding their care. In most countries the preference is     for formal attire. In other places a more casual attire is generally accepted. Israel is a     country where casual dress is acceptable in most settings. Israeli physician's dress code has     been discussed in the past, but has never been systematically studied. The aim of this study     is to systematically examine the attitudes of parents of children who have been admitted to     the pediatric ward towards physicians' attire.   "
115803|NCT01770080|"     Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use)     compared to placebo in patients with episodic tension-type headache (ETTH).      Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups     design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives,     following attacks during study duration will be observed and documented.      Study duration per patient: 10 weeks   "
115808|NCT01770015|"     Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side,     bronchial fungi colonization is commonly observed in ICU; therefore, the investigators     propose to study the role of bronchial fungi colonization on the occurrence of VAP taking     into account the immune status of the patient and the antibiotic and antifungal treatments he     has received.   "
115809|NCT01770002|"     The investigators hypothesize that everting wound edges while suturing surgical sites will     result in more aesthetic scars. Additionally, we also hypothesize that small to moderate     wound irregularities present at 3 months will resolve by 6 months after surgery with no     intervention   "
115810|NCT01769989|"     The purpose of this study is to determine if electrodermabrasion improves the cosmetic     appearance of raise or bumpy scars or scars that are a different color or texture than the     surrounding skin resulting from dermatologic surgery and whether it is as good as to the     already used method of dermabrasion.   "
115811|NCT01769976|"     The aim of this study is to examine whether periodic fasting improves markers of diabetes     risk and cardiovascular health, and will compare this to the effects observed with daily     dieting by energy restriction, and also with no change in energy intake.      It is hypothesized that periodic fasting, with or without weight loss, will be as effective     as daily energy restriction to improve markers of metabolic health and energy metabolism.   "
115812|NCT01769963|"     The purpose of the study is to learn more about how advanced glycation end-products can     affect insulin resistance, inflammation and blood vessel health in people with kidney     disease.   "
115813|NCT01769950|"     Nodal involvement among patients with prostate cancer is known to be a poor prognostic     factor. Traditionally, the presence or absence of nodal disease in patients with prostate     cancer is ascertained with the use of anatomical imaging methods such as computed tomography     (CT) and magnetic resonance imaging (MRI).      However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather     low, with reports placing the value to lie between 50-80%.      Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline     (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of     prostate cancer disease burden in the primary, nodal and the metastatic areas.      The investigators in this prospective trial intend to utilize Choline-PET among all newly     diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease     on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).   "
115814|NCT01769937|"     Systemic lupus erythematosus is a serious and potentially life-threatening condition with     significant unmet medical need. The aim of this Investigator Initiated, single center,     open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ)     injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for     non-responders after day 10 dose. The primary objective of this study is to evaluate whether     the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity     of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.   "
115815|NCT01769924|"     Studies of patients with established kidney disease, even when this is mild, appear to show     that they are at high risk of heart failure, stroke and sudden cardiac death. This may be     because kidney disease causes stiffening of the arteries in the body which means that the     heart and brain are damaged by high blood pressure. By studying patients before and after the     removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for     the first time in man the effect of an isolated reduction in kidney function on the structure     and function of the cardiovascular system.   "
115816|NCT01769911|"     This clinical trial studies genetically modified peripheral blood stem cell transplant in     treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy     before a peripheral stem cell transplant stops the growth of cancer cells by stopping them     from dividing or killing them. After treatment, stem cells are collected from the patient's     blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone     marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the     patient to replace the blood-forming cells that were destroyed by the chemotherapy and     radiation therapy   "
115820|NCT01769859|"     The primary goals of this work are: a) to establish a unique collection of mood disorder     patients across the life cycle, including children, adults and geriatric patients, with     well-defined medical co-morbidities and medication treatment outcomes at the University     Hospitals Case Medical Center Department of Psychiatry; b) to establish a collection of     nuclear families, including both mothers and fathers, of children diagnosed with mood     disorders; c) to perform a systematic genetic analysis of the proposed sample repository to     identify genes and genetic variants contributing to inter-patient variability in clinical     phenotypes and treatment responses. Our primary hypothesis is that genetic variations may     underlie individual variability in disease susceptibility, clinical phenotypes and treatment     safety, tolerability, and effectiveness.   "
115821|NCT01769846|"     Advances in intensive care and mechanical ventilation (MV) in the past two decades have     increased critically ill patient survival. However, some patients require prolonged MV (PMV)     and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse     effects of medications, and prolonged immobilization. Patients in the intensive care unit     (ICU) are often confined to their beds, which results in inactivity, immobility, and severe     osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol     improves peripheral muscle strength, perceived functional status, duration of mechanical     ventilation, ICU length of stay of the critically ill patient.      The purpose of this study is to evaluate the effects of implementation an early mobilization     protocol in critically ill patients in the Intensive Care Unit of the University Hospital of     Santa Maria.   "
115822|NCT01769833|"     This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha     vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels     in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have     an undetectable hepatitis B virus (HBV) viral load at least 1 years.   "
115823|NCT01769820|"     This study builds on previous research which has provided compelling evidence that deficient     activity of glucocorticoids in the endometrium is a cause of increased menstrual bleeding.     This study aims to demonstrate that a glucocorticoid (dexamethasone), already in common use     for other conditions, (eg to treat medical conditions such as asthma and rheumatoid arthritis     in early pregnancy), will reverse the endometrial glucocorticoid deficiency and as a result     reduce menstrual blood loss.      The study is in two stages, a 12 month workup stage and a 3 year, response adaptive,     dose-finding randomised controlled trial. The first stage involves two workup clinical     studies to gather preliminary safety and efficacy data from first-in-Heavy Menstrual Bleeding     use of oral dexamethasone. They will also provide methodological data for a series of     simulation studies to determine a robust adaptive trial design specification.      Workup study 1: is unblinded, six patients will be given Dexamethasone (0.75mg twice daily)     for 5 days during two consecutive menstrual cycles and will have an endometrial biopsy and     MRI on two occasions (in a nontreated cycle, and the second of the cycles treated with     Dexamethasone). Workup study 2; is a doubleblind crossover trial of 14 women -2 treatment     blocks of two cycles each, with either placebo or Dexamethasone (0.75mg twice daily),     randomised to order of treatments blocks - placebo then Dexamethasone, or vice-versa.      Adaptive trial: 54 month double-blind, placebo controlled trial of 108 women to evaluate the     effect of Dexamethasone across a range of doses with the aim of identifying the optimal dose     to be studied in a subsequent Phase III trial.      Participants will be randomised to receive one of 6 active doses or placebo over 3 menstrual     cycles.      All studies will involve asking participants to complete menstrual diaries and to carry out     menstrual blood loss collections to objectively measure blood loss.      The investigators' proposed approach is novel use of synthetic glucocorticoid to rescue     luteal phase deficiency of cortisol, and thus improve endometrial vasculature and hence     vasoconstriction when menses commences, and thus reduce menstrual bleeding.   "
115824|NCT01769807|"     Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have     been described in severe obstructive sleep apnea (OSA), and are reverted by continuous     positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on these     biomarkers in mild-moderate OSA.   "
115825|NCT01769794|"     The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent     Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot,     and mouth disease (HFMD).   "
115826|NCT01769781|"     The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will     be tested for the treatment of women with endometriosis recurrence compared with classical     GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will     be the outcomes for establishing which medical treatment is the best in endometriosis     recurrence treatment.   "
115827|NCT01769768|"     This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on     the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive     800mg daily of LDE225 and two separate doses of either bupropion or warfarin.   "
115828|NCT01769755|"     To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up     to 5 total infusions in subjects with Crohn's disease who are refractory to one or more     standard Crohn's disease therapies.   "
115829|NCT01769742|"     Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In     surgical specialities and critical care early physiotherapy is a recognised way of preventing     such infections, and reducing length of hospital stay (LOS), however prevention of this     problem is less well studied in medical inpatients.      The investigators propose a pilot study to assess the impact of introducing an early     mobilisation strategy to general medical and respiratory wards at an acute Trust in the     United Kingdom (UK). The investigators will recruit all new admissions to each of 2     respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive extra     physiotherapy input targeting new admissions for early mobilisation. Patients' usual     mobility, current mobility and actual activity levels will be studied by accelerometer and     simple patient questionnaire in the first 48 hours of admission, and compared between groups.     Incidence of HAP and total LOS will be recorded and compared between groups.      The investigators hypotheses are that the physiotherapy intervention will increase activity     levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the     National Health Service (NHS), which the investigators will model using local tariff data.      The investigators plan to use our data to power a larger randomised controlled study, or if     the intervention is a marked success, such that a control group would be unethical, then a     wider service development and evaluation programme.   "
115841|NCT01769586|"     Patients who are undergoing colonoscopy and are not adequately sedated after initial standard     sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive     diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our     hypothesis is that diphenhydramine will provide better sedation than continued administration     of midazolam during colonoscopy in patients not achieving adequate sedation with standard     doses of midazolam plus fentanyl.   "
115830|NCT01769729|"     The overall aim of this program of research is to develop a collaborative psychotherapy for     major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid     chronic low back pain (CLBP).      The purpose of the proposed project is to establish the feasibility and acceptability of a     research design for an eventual large-scale randomized clinical trial which would test the     efficacy of PEPP in comparison to a control condition (depression care management).      To achieve the investigators specific aims, the investigators will conduct a pilot randomized     clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures used in     care management) or care management.   "
115831|NCT01769716|"     This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic     umbilical cord blood therapy for children with global developmental delay.   "
115846|NCT01769521|"     Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour     period, especially in the nocturnal period, may lead to insufficient perfusion pressure of     the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior     vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with     progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced     mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of     glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has     not been studied in a prospective manner and remains to be elucidated.      The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation     pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP     fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device     using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.   "
115957|NCT01768078|"     One useful effect of early intravitreal corticotherapy is to diminish inflammatory     complications after endophthalmitis, which may cause, at least in part, serious complications     (retinal detachment, macular edema) which are, more than the infection, causes of the     complications seen after acute endophthalmitis.   "
115832|NCT01769703|"     Objective: Demonstrate the safety of early use of dabigatran following TIA/minor stroke.      Background: Although aggressive antithrombotic therapy has been shown to reduce the number of     new ischemic events following stroke/TIA, this has always been offset by an increase in the     risk of hemorrhagic transformation. Dabigatran is much safer than previously tested     antithrombotic agents, with respect to intracranial bleeding and therefore offers a unique     treatment opportunity in these high-risk patients. TIA/minor stroke represent the largest     group of cerebrovascular disease patients. A short-term intervention such as 30 days of     dabigatran treatment has the potential for a very large impact from the population health     perspective, given the number of patients who may be treated if a benefit can be     demonstrated.      Study design:      This is an open label, single arm study. Patients with TIA/minor stroke (National Institutes     of Health Stroke Scale (NIHSS) score </=3) who can be treated within 24 hours of symptom     onset will be eligible. All patients will be treated with dabigatran for 30 days. The dose of     dabigatran will be determined by age and renal function (patients >80 years old and/or with     GFR 30-50 ml/min will received 110 mg bid, and all other patients will receive 150 mg     BID).The primary endpoint is symptomatic hemorrhagic transformation. Patients (n=50) with     TIA/minor stroke, defined as having a National Institutes of Health Stroke Scale Score of     </=3, will undergo an MRI, including diffusion-weighted imaging (DWI), as well as gradient     recall echo (GRE) sequences, which will be used to assess for hemorrhagic transformation.     Patients will have a repeat MRI examination at 7 and 30 days to assess for hemorrhagic     transformation and new lesion development. The primary endpoint of of phase I is symptomatic     hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 MRI scan (GRE     sequence), associated with clinical worsening (>/=4 point increase in National Institutes of     Health Stroke Scale (NIHSS) score).      If dabigatran can be used safely in this population, a second phase aimed at demonstrating     the rate of new ischemic lesion development following TIA can be reduced with aggressive     antithrombotic therapy. A randomized open-label, blinded endpoint evaluation design will be     employed. The investigators hypothesize that dabigatran therapy administered within 24 hours     of symptom onset will reduce the rate of new ischemic lesions, relative to standard care, one     week and 30 days after onset.   "
115833|NCT01769690|"     The study design is a within-subject randomized cross-over design to evaluate the effects of     DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as     measured by a virtual reality street-crossing simulator.   "
115834|NCT01769677|"     The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone     bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release     tablet.   "
115835|NCT01769664|"     The objective of this study is to compare the relative efficacy and safety of the test     formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the     marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the     treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations     will also be compared to a placebo formulation to test for superiority.   "
115836|NCT01769651|"     Accurately predicting the risk factors of patients' suffering a drug overdose plays a crucial     role in effective prevention of drug overdose. In order to investigate possible risk factors     for drug overdose, the NHS Fife Research & Development Office funded this project to be     carried out by a group of researchers based in the University of St Andrews, in collaboration     with the NHS Fife Addiction Services.      To improve our understanding of drug misusers' risk of suffering a drug overdose, the     investigators focus on the factors that are associated with the aspects of the addiction     consultation process (e.g. verbal and non-verbal behaviours of clinicians and patients). The     investigators are particularly interested in how clinicians recognize and manage patients'     emotional concerns during consultations. Based on the empirical evidence in the area of     patient-centred consultation, the investigators hypothesize that successful management of     patient emotional distress is positively correlated with improved healthcare outcomes     including patient's feeling more emotionally valued and satisfied with the consultation. The     investigators also hypothesize, according to the research findings on the relationship     between facial expressions and suicidal reattempt, that some non-verbal behaviours during     consultation (e.g. patient's 'looking down' activity) are related to patient's risk of     suffering a drug overdose.      After obtaining informed consent from clinicians and patients, the investigators will video     record a patient's first consultation session with a key worker within the NHS Fife Addition     Services. The investigators expect to collect a minimum of 16 consultations (about eight     clinicians with two patients per staff member) for this one-year pilot study. A validated     coding scheme will be modified to code patients' expressions of emotional distress and     clinicians' responses. Additional survey method will be also employed to collect demographic     information and patient satisfaction. The investigators hope the findings of the study will     improve our understanding of drug overdose risk factors and contribute to the development of     drug overdose prevention programmes.   "
115837|NCT01769638|"     This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally     disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's Viagra®     (sildenafil) Film Coated Tablet (FCT) formulation (reference formulation) in healthy     volunteers.   "
115838|NCT01769625|"     This is a biomarker study with the goal of measuring changes in proteins and gene     methylation. This study is not intended for use in diagnosing, mitigating, treating, curing,     or preventing disease.      The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in     combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act     together to decrease breast cancer risk by their effect on certain biological indicators     (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the     breast.   "
115839|NCT01769612|"     The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in     subjects with suspected CL in Tunisia.   "
115842|NCT01769573|"     This research study will test different doses of RG-HRV16 to find the minimum dose needed to     give research subjects cold symptoms of at least moderate intensity. The study will also test     the safety of RG-HRV16. This information will be used in future studies (for example, to test     antiviral preparations, sprays that could protect from getting a cold or decrease cold     symptoms or to understand more about how rhinovirus can lead to asthma worsening). RG-HRV16     is a common cold virus that has been made in a new way and has not been used in humans     before.   "
115843|NCT01769560|"     This study will test whether a tailored, online educational intervention increases HPV     vaccine uptake and intent among female college students.   "
115844|NCT01769547|"     This is a single-arm, open label, two stage, phase II study of dovitinib in patients with     advanced Malignant Pleural Mesothelioma (MPM). The primary purpose of this study is to     evaluate the potential efficacy of dovitinib in the second- or third-line treatment of MPM     using progression free survival (PFS).   "
115845|NCT01769534|"     The purpose of this study is to follow patients, who have small mucinous cysts in the     pancreas, prospectively over a 5-year period.   "
115958|NCT01768065|"     This study will evaluate effectiveness and adherence of the nasal expiratory positive airway     pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea     Syndrome (OSAS). NEPAP is currently approved for use only in adults.   "
115847|NCT01769508|"     With improvements in response rate and survival seen for HER2 positive patients treated with     HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting     to increase antitumor effect shows promise. Patients with previously untreated localized HER2     positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients     meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent     chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in safety     portion, the optimal dose of lapatinib will be determined.   "
115848|NCT01769495|"     Our hypothesis is that a rapid follow up for elderly patients in a Geriatric Clinic     discharged from the Emergency Department (ED) will have fewer unplanned return ED visits and     fewer unplanned hospital admissions with no attendant increase in mortality.      Patients 75 years of age and older will be randomized following discharge from the ED into     two groups. The first will receive standard post ED care. The second will receive an     appointment to our Geriatric Clinic within 2-3 days for stabilization, further treatment and     contact with the patient's primary physician to communicate the course of the patient's     illness and to schedule subsequent follow-up with the patients regular medical provider.      There will be two primary outcomes: The first will be a composite of morality and/or return     to the ED at 30 days, and the secondary primary outcome will be mortality. Economic data     regarding resource utilization by patients will also be analyzed.   "
115849|NCT01769482|"     Current therapeutic options for a well-recognized group of patients with anginal symptoms—a     positive exercise tolerance testing, SPECT or perfusion defect in MRI but angiographically     normal coronary arteries—are limited. The condition, referred to as microvascular angina     (MVA) or cardiac syndrome X, is not as benign as originally reported—patients presenting with     unstable angina and nonobstructive atherosclerotic coronary artery disease have a 2% risk of     death or myocardial infarction at 30 days of follow-up. It is more common in women in whom     the first presentation of angina occurs either perimenopausally or postmenopausally. Aberrant     flow-mediated coronary vasomotion is pivotal in the pathogenesis (systemic) impairment in     endothelial function. Indeed, some centers use systemic assessments of vascular function in     their diagnostic pathways for this group of women. It was recently suggested that endothelial     dysfunction may lead to myocardial ischemia.      In the present study, the investigators tested the hypothesis that udenafil offers dual     benefits of improving vascular function and lessening ischemia in women with angina,     perfusion defect in cardiac MRI, and normal coronary arteries.   "
115850|NCT01769469|"     This is a prospective observational cohort sub-study of subjects enrolled in ATN 110 or ATN     113, which is a prospective interventional trial.   "
115851|NCT01769456|"     Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the     ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine     Trial Units (AMTUs). Assignment to behavioral intervention, which include Many Men, Many     Voices (3MV) and Personalized Cognitive Counseling (PCC), will occur at the level of the     site. Subjects will first complete the behavioral intervention offered at their respective     site and will then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®)     as pre-exposure prophylaxis (PrEP). Behavioral and biomedical data will be collected at     baseline and at 0, 4, 8, 12, 24, 36 and 48 weeks. Any subject who becomes HIV infected during     the course of the study will be discontinued from the study agent and be followed for an     additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects     who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive     visit will be followed for an additional 48 weeks in the Extension Phase to more closely     monitor longer-term outcome of potential concerns.   "
115852|NCT01769443|"     The primary objective is to evaluate the efficacy of desensitization therapy, which includes     VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart     transplantation.   "
115866|NCT01769261|"     Evolution of patient's health after hospital discharge is poorly documented. The     investigators hypothesize that information of good quality on this concern might be     accessible at a relatively low cost from patients, further referred to as sentinel patients,     who would voluntary report their health evolution on a dedicated web site.      The SENTIPAT study presents as a proof of concept study. It will collect patient's health     evolution during a post-hospital discharge period of 45 days. The study presents as a     randomized trial comparing patients' reports issued from two different methods in a patient     population returning home after hospital discharge and having at disposal an internet access     at home:      in the  internet  arm, sentinel patients will be solicited to directly report their     post-discharge health evolution on a website especially devoted for collecting these data     while in the  telephone  arm, the same items will be collected through a telephone     interview 45 days after hospital discharge. Investigations will focus on post-discharge     adverse events and will include appearance/worsening of symptoms, healthcare resources     utilization, quality of life, and patients' satisfaction.   "
115853|NCT01769430|"     The recent swine origin influenza pandemic (2009), new emergence of swine origin H3N2v, and     delayed availability of vaccine for these agents highlight the need to test and optimize     public health intervention strategies to reduce transmission of influenza. We will use a new     technology for biological particle collection (U.S. Provisional Patent Application No.     61/162,395, McDevitt et al., Aerosol Sci Technol 2013) to make fundamental observations on     infectious respiratory droplets in a study of up to 200 naturally occurring seasonal     influenza cases. We will collect respiratory droplets shed by participants while breathing     normally, talking, and spontaneously coughing. We will characterize the size distribution of     droplets containing infectious virus. We will use these basic data to examine the roles of     large and small respiratory droplets and examine how the interaction of host factors and     virus type impact the shedding of infectious respiratory droplets. Subjects will be recruited     through a web based respiratory illness surveillance system, health clinics and advertisement     in the campus community. Sitting in the collection booth will not create additional     discomfort or risk for volunteers already suffering from influenza infection. We will recruit     up to 1000 persons with symptoms of acute respiratory illness for screening with collection     of nasopharyngeal swabs and questionnaire. From among those screened, we will recruit 250 to     give exhaled breath samples, and ask 50 people with influenza to return for follow up exhaled     breath samples on up to two subsequent days. We hypothesize that (1) fine aerosols (<5     microns in aerodynamic diameter) will contain more viral copies than coarse aerosol particles     (>= 5 microns) (2) fine aerosols will contain culturable virus indicating that the fine     aerosols are infectious, (3) aerosol shedding will correlate with virus load measured by     swabs, (4) presence of active cough during sampling will be associated with increased aerosol     shedding, (5) clinical symptoms and signs, including fever can be used to predict viral     aerosol shedding.   "
115854|NCT01769417|"     This is a Phase 1, first time in human study enrolling approximately 33 healthy adult     subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the     safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single     IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially.     Subjects will be followed for safety from the time of Informed Consent through 360 days post     dose.   "
115855|NCT01769404|"     This study has two parts. Each participant will receive a daily injection of LY2605541 during     one treatment period and a daily injection of insulin glargine during one treatment period.     Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar     levels to see how the body recovers after each treatment.   "
115856|NCT01769391|"     The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy     of paclitaxel and carboplatin is more effective to treat cancer than the standard     chemotherapy of paclitaxel and carboplatin alone.   "
115857|NCT01769378|"     The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide     compared to placebo in participants with type 2 diabetes who have inadequate glycemic control     with sulfonylurea monotherapy.   "
115858|NCT01769365|"     To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day     quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected     patients were randomly assigned to a 7-day standard triple therapy (pantoprazole,     clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and     amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a     further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and     metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter     pylori eradication rates between three groups.   "
115859|NCT01769352|"     The purpose of this study is to compare the change in visual acuity of patients with post     surgical cystoid macular edema who will be treated with two different regimens.   "
115860|NCT01769339|"     The purpose of this study is to evaluate the efficacy and safety of miconazole plus     hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast     infection of the vulva).   "
115861|NCT01769326|"     The purpose of this research study is to compare different methods for training hand movement     at home after stroke. This study involves research because it will test two experimental     devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand     and arm exercises. The MusicGlove is a glove that measures finger movements and allows its     user to play a musical computer game using those movements. The RAE is a lever that attaches     to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the     arm.   "
115862|NCT01769313|"     This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized,     prospective, single-center, multi-surgeon, investigator masked study to investigate whether     the femtolaser cataract surgery causes any significant differences in the resulting Intra     Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous     curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the     difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of     mass.   "
115863|NCT01769300|"     The specific aim of this cluster-randomized (site) comparative effectiveness research study     is to determine whether children who are (1) 5-12 years of age, (2) cared for in ePROS     practices or clinics using an electronic health record (EHR), (3) have attention-deficit     hyperactivity disorder (ADHD), and (4) are to receive treatment with stimulant medication for     the first time in these practices, have superior clinical outcomes if their clinicians have     access to an EHR-guided clinical decision support system (intervention group) than if their     clinicians have no such access (control group).   "
115864|NCT01769287|"     The purpose of this study is to check if at 1 year after surgical ablation the electrical     impulses that cause atrial fibrillation (AF) are still blocked from being able to get into     the heart.      Hypothesis Conduction block and ganglionic destruction are required for freedom from AF.   "
115865|NCT01769274|"     The purpose of this study is to evaluate the efficacy and safety of single doses of     PF-05089771 against placebo in treatment of pain in patients with primary, inherited     erythromelalgia.   "
115880|NCT01769079|"     Chronic treatment of stable angina with nitrates long and short action is extremely frequent.     In clinical practice the most commonly observed is a combination of anti-anginal agents,     usually including nitrates fixed in an attempt to improve the quality of life of patients,     which is not always met with success.      Numerous questions and problems are seen with chronic use of oral nitrates. From a practical     standpoint, some advocate the withdrawal of medication in stable patients, while many     physicians still hesitate to withdraw the medication by the lack of definitive information     about its consequences. In this sense there is a rationale for the attempted removal of     nitrate fixed these patients, although evidence to support this action have not been     adequately evaluated.   "
115881|NCT01769066|"     The aim of this study is to explore the Clinical Value of Sequential Gefitinib With     Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.   "
115867|NCT01769248|"     Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving     the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate     - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has     traditionally been done with fine needle aspirate where a needle is inserted into the tumor     and potentially malignant cells are extracted for microscopic analysis. More recently, a     needle that allows a tissue biopsy for histologic analysis has been FDA approved.      The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide     excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges     from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring     histology for diagnosis. However, there is currently only limited data from prospective     studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a     randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to     EUS-FNB.   "
115868|NCT01769235|"     The objective of this study is to compare the safety and efficacy profiles of Taro     Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya®     (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior     efficacy of the two active formulations over that of the vehicle in the treatment of acne     vulgaris.   "
115869|NCT01769222|"     This pilot phase I/II trial studies the side effects and best of dose ipilimumab when given     together with local radiation therapy and to see how well it works in treating patients with     recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies,     such as ipilimumab, can block cancer growth in different ways. Some block the ability of     cancer cells to grow and spread. Others find cancer cells and help kill them or carry     cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer     cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective     treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer   "
115870|NCT01769209|"     This phase II trial studies how well giving bortezomib together with combination chemotherapy     works in treating patients with relapsed or refractory acute lymphoblastic leukemia.     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth.   "
115871|NCT01769196|"     The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on     progression-free survival (PFS) as determined by either a categorical decline in forced vital     capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of     participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified     level in serum at baseline.   "
115872|NCT01769183|"     The purpose of this study is to determine the efficacy in the use of topical Squalamine     Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting     from proliferative diabetic retinopathy.   "
115873|NCT01769170|"     The purpose of this study is to compare the effectiveness of CMX001 to placebo for the     prevention of CMV infection in stem cell transplant patient who do not have CMV before     starting treatment with CMX001.   "
115874|NCT01769157|"     L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary     excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation     increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine     to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue     score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine     and placebo in hypothyroid patients who had taken levothyroxine.   "
115875|NCT01769144|"     This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA)     and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.   "
115876|NCT01769131|"     An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for     mobilization of the cervix during common gynecologic office procedures.      The primary object is to determine the presence of a difference in pain perception between     the two instruments.      The secondary objective is to evaluate the differences in the frequency of bleeding, that     requires treatment, after removal of the instrument and the need to use an alternative     instruments.   "
115877|NCT01769118|"     Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm     infant who get caffeine before stopping ventilation. The investigators hypothesis is that     this stimulatory effect may be characterized by HRV analysis methods.   "
115878|NCT01769105|"     Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated     thermal pulsation with the Lipiflow® system have been reported in several case reports. In     one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However,     treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia     followed by lid massage and lid margin cleansing over several months. To the best of the     investigators knowledge this is the first randomized prospective study to compare automated     thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene     regime.      The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene     regime.   "
115879|NCT01769092|"     For many years, there has been interest in the question of whether a special diet of some     sort could be used to help control epileptic seizures. The ketogenic diet has been used since     the 1920s, but it is used only in children, and is nutritionally unbalanced. It is typically     withdrawn after 3 years. The ketogenic diet unfortunately, offers no long-term solution to     seizure control.      Our preliminary research now suggests that there may be a healthy, long-term dietary approach     to controlling seizures.      Based on our animal work and published clinical studies the investigators hypothesize that a     DHA dose of 3 g/day will reduce seizure frequency in patients with intractable seizures.   "
115894|NCT01768897|"     This phase I trial studies the side effects and best dose of CPI-613 when given together with     cytarabine and mitoxantrone hydrochloride in treating patients with relapsed or refractory     acute myeloid leukemia. Drugs used in chemotherapy, such as CPI-613, cytarabine and     mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either     by killing the cells or by stopping them from dividing. CPI-613 may help cytarabine and     mitoxantrone hydrochloride work better by making cancer cells more sensitive to the drugs   "
115895|NCT01768884|"     Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability of     Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa     Bronchiolitis is defined as an infection of the small airways. It is also the most common     manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the     leading cause of global child mortality. NO has been shown to play a critical role in various     biological functions, including the vasodilatation of smooth muscle, neurotransmission,     regulation of wound healing and immune responses to infection such as microbicidal action     directed toward various organisms. NO in the airways is considered to play a key role in the     innate immune system in which the first-line of host defense against microbes is built.      It has shown the beneficial effect of NO in different diseases with several options of doses     and regimens - from newborn with primary pulmonary hypertension which showed improvement in     oxygenation after 30 minutes of NO treatment at 10-20 ppm, to a subject with adult     respiratory distress syndrome, who demonstrated clinical improvement during NO treatment at     18 and 36 ppm.      In vitro studies utilizing a variety of nitric oxide (NO) donors suggested that NO, in part     per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a     wide variety of phyla including bacteria, viruses, helminthes and parasites.      Primary Objectives: Assess the safety of NO intermittent inhalation treatment in 2-12 month     old bronchiolitis subjects. Assess the tolerability of NO intermittent inhalation treatment     in 2-12 month old bronchiolitis subjects Secondary Objective: Assess the efficacy of NO     intermittent inhalation treatment compared to standard treatment in 2-12 months old     bronchiolitis subjects.      Prospective, double blind, randomized single-Center study of 44 hospitalized subjects aged 2     -12 months old, diagnosed with bronchiolitis will be enrolled into the study and randomized     into 2 groups. Group 1 -Treatment group - Will receive nitric oxide inhalation in addition to     standard treatment for up to 5 days, Group 2 - will receive ongoing inhalation of the     standard treatment for 5 days.      Treatment administration: Treatment blindness will be kept by separating between unblinded     team members (giving the actual treatment) and blinded team members, and by hiding the NO     container and all study related equipment behind a curtain. Between study inhalations the     subject will continue to receive the standard inhalation treatment. Oxygen (O2), NO ,     nitrogen dioxide(NO2)and fraction of inspired oxygen (FiO2) delivered to the patient will be     continuously monitored.      All subjects will come for follow up visits on day 7(+5), 14 (+5) days and will be contacted     on day 30 (+5) from day of admission to the department.      End of study treatment (both groups) will be assessed by a blinded study physician base on     clinical assessment. Subject improvement that will lead to end study treatment = clinical     score < 6 and/or (Oxygen saturation)SaO2 above 92% and/or decision of subject discharge from     the hospital.   "
115882|NCT01769053|"     In 2008 a new ventilation strategy termed variable Pressure Support ventilation (PSV) was     introduced, which is able to increase the variability of the respiratory pattern independent     from the inspiratory effort. In experimental lung injury, variable PSV was found to improve     gas exchange and decrease the inspiratory effort, while reducing alveolar edema and     inflammatory infiltration compared to conventional(non-variable) PSV. Importantly, variable     PSV reduced peak airway pressure and respiratory system elastance in a variability dependent     manner.In addition, preliminary observations suggest that variable PSV can reduce the work of     breathing and improve patient comfort, but it is not known whether this new ventilatory     strategy is able to speed the weaning from mechanical ventilation.      Since variable PSV can reduce the mean pressure support, it may lead to a faster reduction of     pressure support and, therefore, a shorter weaning period than conventional PSV.      The hypothesis of this study is that variable pressure support ventilation reduces the     duration of mechanical ventilation to non-variable (conventional) pressure support     ventilation.   "
115883|NCT01769040|"     This investigational trial will be assessing the effect of rifaximin on pathophysiology and     haemodynamics in the patient with liver cirrhosis, and addressing the effect of rifaximin on     several organs on marker level. The molecular and physiological effects of rifaximin will be     explored.      The investigators hypothesize that intestinal decontamination with rifaximin in patients with     cirrhosis and ascites will interrupt bacterial translocation from the gut, diminish the     following inflammatory response, prevent splanchnic vasodilatation and portal systemic     contraction and thereby reduce the risk clinical complications to cirrhosis.      If rifaximin can correct small intestinal bacterial overgrowth and demonstrate improvement in     liver haemodynamics, renal function and systemic dynamics, then these effects may contribute     to the overall well-being of the patient and prevent complications to the underlying     cirrhosis such as risk of infections, progression of disease, and admission to hospital.   "
115884|NCT01769027|"     An increasing body of evidence indicates that an immune basis might underline a number of     pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had     Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic     streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric     autoimmune neuropsychiatric disorders associated with streptococcal infections. More     recently, several PANDAS variants have been described, including adult-onset variant. There     are many evidences that OCD/tic symptoms could be due to an immunologic reaction against     brain tissues following a streptococcal infection.      The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to     improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or     azithromycin in case of penicillin allergy) is more effective than SSRI only.      Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin     (IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment response     is based on the lack of a Y-BOCS score improvement of at least 35%).      Objectives:        -  To determine the safety and efficacy of SSRI+AB compared to SSRI only.        -  To test the safety and additional beneficial effects of high dose of IVIG on antibiotic          prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.      Study methodology:        -  Participants will be screened to obtain medical history and other information at          Neurologic and Psychiatric Sciences Department of Florence University Hospital and at          Paris-est University.        -  Participants will receive a treatment of either SSRI+AB or SSRI+placebo for 12 weeks          (double-blind randomized trial)        -  Patients who will not respond to AB will be admitted to the hospital to receive IVIG for          5 days, for 5 consecutive months.        -  Follow-up visits will take place 3 and 6 months after the first evaluation, followed by          6 months follow-ups for 3 additional years.      Blood samples (including blood cytokine determination), ECG, Doppler and 2-dimensional     echocardiogram EEG, imaging studies (2 tesla MRI), and other tests will be performed both     before and after the treatment with SSRI+AB or SSRI+placebo and in case also after IVIG     treatment.   "
115885|NCT01769014|"     It is the goal of this study adherence and quality of life in a population of people     suffering from schizophrenia or schizoaffective disorder and to analyze if these factors are     influenced by treatment, support, social services, and residential treatment. The study     population is drawn from the the cantons Glarus and Graubunden as well as Liechtenstein.   "
115886|NCT01769001|"     Patients will be enrolled into one of three PRX-102 dosing groups (0.2 mg/kg, 1.0 mg/kg, 2.0     mg/kg), to receive the same dose they had received in Phase 1/2 study PB-102-F01, and will     continue to receive PRX-102 as an intravenous infusion every 2 weeks for 38 weeks.   "
115887|NCT01768988|"     This is a randomized, double blind controlled, parallel arms trial, aimed to assess the     efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study     include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing     the presence of central sensitization and its potential reversion by Pregabalin; (3)     assessing quality of life of patients treated with pregabalin in comparison to placebo; (4)     to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5)     to compare anxiety and depression in patients treated with pregabalin in comparison to     placebo.   "
115888|NCT01768975|"     The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in     subjects with moderate to severe pain associated with osteoarthritis of the knee following     cessation of pain therapy.   "
115889|NCT01768962|"     To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin 1% gel after 2     weeks of daily rectal use and after 2 weeks of daily vaginal use   "
115890|NCT01768949|"     The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring     the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers     in patients suffering from acute respiratory distress syndrome   "
115891|NCT01768936|"     Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after     initial operative focus elimination to investigate the PCT ratio's impact on decision-making     for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic     peritonitis.   "
115892|NCT01768923|"     To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011     American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of     remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints     [DAS28] <2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.      To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis   "
115893|NCT01768910|"     The purpose of this study is to provide profound insight into the supraspinal neuronal     mechanisms and networks responsible for lower urinary tract (LUT) control and to verify,     amend or adjust neuronal circuitry models established from findings in healthy subjects in     the context of neurogenic and non-neurogenic LUT dysfunction.   "
115896|NCT01768871|"     The primary objective of this study is to evaluate the function of the knee after a total     knee replacement with the VEGA system®.   "
115897|NCT01768858|"     The main purpose of this study is to assess patients` adherence attitudes (beliefs) to the     maintenance therapy with a scheduled Adalimumab monotherapy or a combination therapy with     methotrexate and to investigate whether there are correlations between such beliefs and     adherence to maintenance treatment.   "
115908|NCT01768715|"     Patients with alcoholic hepatitis non-responsive to steroids have a poor prognosis. Recently     a French-Belgian prospective study has obtained good results (acceptable survival with a low     rate of alcohol recidivism).      The hypothesis of the present study is that carefully selected Spanish patients with     alcoholic hepatitis that do not respond to steroid therapy may have a good survival if they     receive a liver transplant. The expected rate of alcohol recidivism in such a selected     population will be low.   "
115909|NCT01768702|"     Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to     standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.   "
115960|NCT01768039|"     Two hundred and forty patients with multiple sclerosis who met the study criteria will be     enrolled in this randomized double blind placebo-controlled clinical trial.      They will randomly assigned to placebo or vitamin D treatment group. The total time of study     is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU)     vitamin D, while the other group will receive weekly placebo. The annual relapse rate and     EDSS will be compared at baseline, month 6 and 12.   "
115898|NCT01768845|"     Hematopoietic progenitor cell (HPC- primitive cells in the blood, bone marrow and umbilical     cord that can restore the bone marrow) transplant can be a curative therapy for the treatment     of hematologic malignancies (a disease of the bone marrow and lymph nodes). The source of     cells used for the transplant comes from related (sibling) and in cases where there is no     sibling match, from unrelated donors through the National Marrow Donor Program. The     availability of a suitable donor can be a significant obstacle for patients who need a     transplant but do not have a matched donor. Cord blood that has been harvested from an     umbilical cord shortly after birth has a rich supply of cells needed for transplant. These     stored cord bloods are now being used to transplant adults without a matched donor      Advantages to using cord blood includes a readily available source of cells with no risk to     the donor during the collection process, immediate source of cells in urgent situations (no     lengthy donor work-up)and a reduction in infectious disease transmission to the recipient.      One of the main disadvantages is the cord blood has a small number of cells needed for     transplant. In an adult, usually two cords are needed and large recipients do not qualify     because they need too many cells.      This study will use two different preparative regimens (chemotherapy and radiation) followed     by one or two umbilical cord units (UBC). The preparative regimen used will be chosen by the     physician and is based on patient's age, disease and medical condition at the time of     transplant.      Multiple objectives for this study include disease-free and overall survival, treatment     related mortality, rate of cells taking hold, and the incidence and severity of the     transplant complication called graft versus host disease (GVHD).   "
115899|NCT01768832|"     Parkinson disease (PD) is characterized by substantial disability and reduced quality of     life, both of which can be attributed in large part to difficulties with walking. Evidence     suggests that exercise may be an important addition to traditional treatments, particularly     with respect to addressing walking problems. In particular, dance and treadmill training have     been individually shown to improve walking performance and quality of life. At present it is     not clear whether dance or treadmill training have similar effects or if one is superior to     the other. Furthermore, our understanding of the means by which these exercise interventions     convey benefits is extremely limited. This study aims to address these knowledge gaps by     directly comparing dance, treadmill training and stretching (control group). The primary area     of interest is the effects on gait, with secondary measures of disease severity, balance, and     quality of life. The investigators will determine not only the effects of the interventions     on walking performance, but will also investigate the effects of the interventions on     connections between different parts of the brain and on brain function during imagined     walking tasks using functional magnetic resonance imaging (fMRI). Participants will be     randomly assigned to dance, treadmill training, or a stretching/flexibility control group.     Participants will be assessed over a period of 6 months at 3 different time points. The     investigators hypothesize that both dance and treadmill training will lead to improvements in     forward walking, but that dance will result in greater improvements in backward walking     compared to treadmill training. Furthermore, the investigators hypothesize that the tango and     treadmill interventions will have different effects of brain function and brain connections.     The investigators expect dance to enhance the activity and connections of particular brain     regions and treadmill training to enhance activity and connections of different brain     regions. The investigators do not expect changes in brain activity or connections in the     control group.   "
115900|NCT01768819|"     Although some authors have observed favorable effects of group physical activity programs,     others have reported that the individualized prescription of exercises may be jeopardized by     programs that do not allow sufficient consideration of individual characteristics. Therefore,     we aim to verify the effects of an elderly-specific multimodal physical activity program on     physical parameters after one year of intervention.   "
115901|NCT01768806|"     This study is a large, multi-site, randomized controlled NIH trial that evaluates whether The     P.L.A.Y. (Play and Language for Autistic Youngsters) Project is effective. The PLAY Project     Home Consultation model coaches parents, through monthly home visits and the use of video     feedback, to effectively interact with their young child with autism. The aims of the study     are 1.) to show that the PLAY Home Consultants show fidelity to the model, 2.) that     caregivers can be taught to interact in an engaging way with their child (with causing more     stress), 3.) that the child then interacts better, improves his/her language, and has reduced     severity of his or her autism.   "
115902|NCT01768793|"     This project will test a novel lifestyle intervention to help overweight and obese     socioeconomically disadvantaged African American women achieve healthy weight control during     and after pregnancy and improve the health of their offspring. The treatment will be given     through an existing national home visiting program, Parents As Teachers (PAT), which will     facilitate sustainability and nationwide dissemination, if effective. We hypothesize that     compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle     intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine     recommendations for gestational weight gain.   "
115940|NCT01768299|"     A double-blind randomized controlled trial to compare a shorter interval between the     administration of mifepristone and misoprostol (simultaneous administration compared to     24hours from administration of mifepristone to receipt of the first dose of misoprostol) for     termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a     shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing     the duration of the procedure and in turn, the duration of hospitalization.   "
122602|NCT01681199|"     The study is designed to assess the effect of statin on atherosclesrosis progression as well     as to explore its potential mechanism besides lipid modifying , such as effect on     inflammation and vascular calcification.   "
115903|NCT01768780|"     Various methods are used to assess the level of anesthesia block after spinal anesthesia.     Among them, ice cubes, alcohol swabs, and needles are commonly used in the clinical setting,     but ice is limited by difficulties with management and transportation, and needle assessment     has problems owing to the risk of pain, infection, and injury to the patient.      Hence, the alcohol swab is commonly used in practice. However, the absence of pain is more     important in the surgical process, and assessing the pain block level is more feasible in     practice than assessing the sensory nerve block level using the alcohol swab.      Therefore, it seems to be better to use the peripheral nerve stimulator for the accurate     assessment of the pain block level. This has the advantage of continuous measurement of the     block level, which can be used in a practical manner in conjunction with the surgical     incision.      Hence, the author compared the conventional method using the alcohol swab with the use of the     peripheral nerve stimulator to determine which method is more practical in the measurement of     spinal anesthesia block level.   "
115904|NCT01768767|"     This study is looking at the safety and efficacy of combined ketamine and lithium therapy for     treating patients with bipolar depression who are taking a mood stabilizer that is not     working for them.   "
115905|NCT01768754|"     A growing body of evidence suggests that in individuals with chronic lung disease their walk     speed is related to their daily function and quality of life. It is possible to assess their     usual (routine) and fast walking speeds by getting them to walk in a flat hallway.      In individuals with chronic lung disease, we anticipate that their usual walk speed will be     helpful in exercise prescription and use in multidimensional scoring systems. However, it is     important to first determine the measurement properties of these two walk speeds.   "
115906|NCT01768741|"     The purpose of this study is to investigate the clinical value of laparoscopic liver     resection in the treatment of hepatocellular carcinoma by assessing its Surgical and     oncologic outcomes comparing with open liver resection.   "
115907|NCT01768728|"     The purpose of this study is to investigate the influence of the laparoscopic and open left     hemihepatectomy on acute surgical trauma and stress response.   "
115910|NCT01768689|"     Adherence to tyrosine kinase inhibitors is associated with improved outcomes in chronic     myeloid leukemia patients. Hence, improved adherence might improve CML patients' prognosis.      Decreased adherence is a common problem in such patients, with non-adherence in up to 30% of     patients in several studies. Recently, an emphasis has been placed on improving patient's     adherence to tyrosine kinase inhibitors in these patients. However, there is no prospective     high-quality evidence showing that adherence can be improved in these patients.      Therefore, the investigators hypothesize that adherence-encouraging interventions improve     adherence to tyrosine kinase inhibitors in chronic myeloid leukemia patients.   "
115911|NCT01768676|"     The purpose of this study is to determine whether avanafil will affect different aspects of     sperm production.   "
115912|NCT01768663|"     The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin,     itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with     ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with     ivacaftor on lung function.   "
115913|NCT01768650|"     This study seeks to compare two different behavioral treatments for pain in Veterans with a     history of TBI. Both treatments involve educating the Veteran about pain, discussing the     impact of pain, and different ways to manage it in hopes of decreasing pain and its impact on     life. These approaches are called self-management approaches to pain. Both of these     treatments are commonly used in pain clinics to treat pain in persons with back pain,     headaches, and other types of chronic pain. The investigators will be delivering both     treatments over the telephone to make the treatments accessible to Veterans wherever they     live.   "
115914|NCT01768637|"     Higher coronary in-stent thromboses and bleeding complications on anti-platelet agents are     more common in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Poor     inhibition of platelet aggregation by anti-platelet agents predicts future cardiovascular     events. Clinical practice guidelines are ambiguous about the use of these agents in Chronic     Kidney Disease due to lack of controlled studies. The investigators hypothesize that patients     with Chronic Kidney Disease compared with non-Chronic Kidney Disease have reduced platelet     aggregation and poor platelet inhibitory response to aspirin. The aims are to 1) define the     range of whole blood platelet aggregation in stages 3-5 Chronic Kidney Disease patients; 2)     investigate whether patients with stages 4-5 Chronic Kidney Disease vs. non-Chronic Kidney     Disease have lower platelet aggregation or impaired von Willebrand Factor activity; and 3)     compare inhibition of platelet aggregation from baseline after 2 weeks of aspirin therapy and     another 2 weeks of clopidogrel therapy added to aspirin in Chronic Kidney Disease vs.     non-Chronic Kidney Disease patients. Accomplishing these aims will provide pilot data to     power future studies of targeted anti-platelet agent treatments in Chronic Kidney Disease in     order to improve cardiovascular outcomes.   "
115915|NCT01768624|"     The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up     Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that:      (i)Made the transition to home dialysis, after an initial start on center-based dialysis.      (ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed     plans for conservative care.      The hypotheses to be tested in the PINOT follow-up study are:        1. 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not          commence home dialysis within 3 years, and instead remain on centre-based haemodialysis;          and,        2. less than 15% of stage 5 chronic kidney disease patients who plan for conservative care          commence dialysis within 3 years.   "
115916|NCT01768611|"     Cells damaged by hyperglycemia are unable to downregulate glucose entrance in presence of     high extracellular glucose resulting in intracellular activation of deleterious biochemical     pathways. Expression of GLUT-1, the major glucose transporter in mesangial cells, is     increased and participates in the induction of diabetic nephropathy. Variants in the gene     encoding GLUT-1 (SLC2A1) have been associated to this diabetic complication. The aim of this     study was to test whether polymorphisms in SLC2A1 confer susceptibility to diabetic     nephropathy in Brazilian type 1 diabetes patients.   "
117194|NCT01751945|"     The purpose of this study is to determine whether an integrated EmONC package (community     mobilization, training of community-based health care providers and a maternal and neonatal     health pack) reduce perinatal and neonatal mortality.   "
115917|NCT01768598|"     Boys suffer a disproportionately large number of fractures compared to girls (55-60%). This     study aims to determine why this is the case by identifying risk factors for wrist fractures.     The increase in fracture during childhood and adolescence may be associated with 1)     risk-taking behaviour in boys, 2) obesity trends in boys during childhood and adolescence,     and/or 3) impaired acquisition of bone strength during childhood and adolescence. Importantly     from a knowledge translation perspective, modifiable factors such as behaviour, dietary     habits or physical activity in boys may predict fracture.      The investigators will measure 400 children (100 girls and 100 boys who have sustained a     fracture; 100 same age and sex friends) across 4 years of growth. This study will assess risk     behaviours, diet, physical activity, motor proficiency (i.e., balance and coordination), fat     and muscle mass and bone strength to determine if there are, 1) differences in whether all or     some of these factors predict fractures in boys compared with girls and, 2) whether these     factors track forward similarly in boys compared with girls as children advance through the     growth spurt.   "
115918|NCT01768585|"     This study investigates whether chronic heart rate reduction with ivabradine (Procoralan®,     Servier, France) affects aortic compliance and endothelial function in patients with chronic     stable coronary artery disease.   "
115919|NCT01768572|"     Primary Objective:      To assess, in the same study, the safety of sarilumab and tocilizumab in participants with     rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis     factor (TNF) antagonists.   "
115920|NCT01768559|"     Primary Objective:      - To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin     (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not     adequately controlled on insulin glargine ± metformin.      Secondary Objectives:      - To compare the treatments/regimens on:        -  The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,        -  Body weight,        -  Self-Monitored Glucose profiles,        -  Fasting Plasma Glucose (FPG),        -  Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test          (subset of participants),        -  Daily doses of insulins,        -  Safety and tolerability.   "
117969|NCT01741818|"     The purpose of this study is to determine the cutoff point for IVC collapsibility index (by     Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP     measures less than 8 cmH2o.   "
115921|NCT01768546|"     Over the past 40 years, diabetes has increased dramatically in parallel with rapid increases     in obesity.About 90 to 95% of persons with diabetes have type 2 diabetes, which begins when     the body becomes resistant to the hormone insulin. Insulin resistance results from weight     gain and physical inactivity, making the vast majority of new cases of type 2 diabetes     preventable with lifestyle changes.      After the findings of the Diabetes Prevention Program were released in 2002, the high cost of     the lifestyle program prevented it from becoming widely adopted throughout the U.S.      The UnitedHealth Center for Health Reform and Modernization (CHRM) will evaluate the use and     effectiveness of a scalable approach for providing lifestyle-based diabetes prevention     intervention through Comcast's XFINITY Video-On-Demand (VOD) programming, with additional     non-compulsory support from SparkPeopleTM (Cincinnati, Ohio), an interactive tracking and     problem solving web portal. By design, this effort will engage adult television viewers and     offer them education and resources to support their efforts to achieve levels of weight loss     and physical activity which have previously shown to prevent the development of type 2     diabetes. Specifically, we aim to evaluate:        1. Viewing patterns and characteristics of consumers accessing a prevention program via VOD        2. Effectiveness in terms of weight loss achieved        3. Consumers' ratings of overall content   "
115922|NCT01768533|"     The goal of this study is to do formative research which will lead ultimately to the     development of a computer-based system called Tailored Information for Diet and Exercise or     TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in     children. The system will be used by physicians and parents/primary care givers in pediatric     primary care practices with the aim of improving parent-pediatrician interactions related to     counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to     develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of     the child in the waiting room and assesses topic areas related to energy balance behaviors     (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire     (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey     administration.   "
115923|NCT01768520|"     This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm     in terms of the efficacy and safety through the change of K-WOMAC's total score sum in     patients with osteoarthritis of knee.   "
115924|NCT01768507|"     Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to     evaluate the HO-1 stimulation of resveratrol in healthy humans.   "
115925|NCT01768494|"     Patients presenting to the emergency department (ED) currently face inacceptable delays in     initial treatment, and long and costly hospital stays due to suboptimal initial triage.     Accurate ED triage should focus not only on initial treatment priority, but also on     prediction of medical risk and nursing needs to improve site of care decision and to simplify     early discharge management. Herein, we propose a large prospective cohort study to optimize     initial patient triage for (a) better determination of initial treatment priority, (b)     overall risk and need for inhospital treatment and (c) early assessment of post-acute nursing     needs.   "
115926|NCT01768481|"     Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary     outcome is intima media thickness before and after intervention.   "
115927|NCT01768468|"     This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet     and Joins tablet in the treatment of osteoarthritis of the knee.   "
115928|NCT01768455|"     The objective of the study was to investigate the pharmacokinetic drug interaction between     gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly     and each alone.   "
115941|NCT01768286|"     This study is to evaluate the safety, tolerability, and antiviral efficacy of     ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV)     administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1     hepatitis C virus (HCV) infection.   "
115929|NCT01768442|"     The investigators' goal is to incorporate advanced imaging information into the treatment     planning process and assess response in tumor, nodes and non-cancerous tissues in head and     neck cancer patients during and after concurrent chemotherapy and radiation therapy (chemoRT)     via biophysical, biochemical and vascular imaging using magnetic resonance imaging (MRI). The     investigators will recruit 30 patients with locally advanced head and neck cancer into the     study. All patients will obtain an advanced MRI study at three time points: 1) before the     start of chemoRT, 2) 4 weeks following the start of chemoRT, and 3) 3-4 months following     completion of chemoRT. MRI scans will include a) T1, T2 and T2* imaging, b) vascular images     using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using     diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. The     subject's response (tumor, nodes and salivary and mucosal tissues) will be evaluated using     clinical outcomes. Correlations will be generated between the parameters obtained from MR     images and from clinical response assessments.      The purpose of this study is to assess whether advanced MR imaging techniques can be used to     determine tumor and node response (i) four weeks following initiation of concurrent chemoRT     and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced     MR imaging techniques can be used to predict early at-risk organ function (salivary gland and     mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i)     four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in     head and neck cancer.   "
115930|NCT01768429|"     The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself     differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum     inflammatory markers. Lipidomic profiles and gene expression will be used for thorough     assessment of the possible clinical changes. The study will compare the effects of     alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The     results of this project will help to identify the optimal source of n-3 fatty acids, and     reveal the significance of the components of fish other than fatty acids. These data will be     useful both nationally and internationally, since highly controlled dietary interventions     utilizing new methodology are scarce.   "
115931|NCT01768416|"     The purpose of this study is to use the BIS monitor to assess the degree of consciousness in     pre-terminal palliative patients admitted to our palliative care unit and to ascertain if     this tool provides a more accurate assessment of consciousness in this specific group of     patients than clinical observation of consciousness and the use of sedation scales.      We hypothesize that the measured BIS results provide a more accurate assessment of the     patient's level of consciousness than routine clinical observation or the use of sedation     scales.   "
115933|NCT01768390|"     AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride     dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed     orthodontic appliances (FOA).      The null hypothesis is that neither incidence nor severity of lesions would differ from a     control group using standard fluoride dentifrice.      SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4     Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000 ppm     fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for     inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected     duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their     teeth during 2 minutes twice daily during the entire period of treatment. Before bonding, and     after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the     maxillary incisors, canines and premolars are taken. At debonding, remaining composite     material on the surfaces is removed with a slow rotating carbide bur followed by polishing     with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is     thereafter exposed.      The primary outcome measure is the incidence and severity of WSL as registered separately by     two blinded experienced and calibrated clinicians according to a validated index. A random     sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The     intervention is indended run throughout the full duration of the orthodontic treatment,     varying between 18 and 24 months.   "
115934|NCT01768377|"     The purpose of this study is to compare intubation with nerve block with intubation with     sedation in awake patients in terms of efficacy, ease, and the rate of complications and     physician satisfaction   "
115935|NCT01768364|"     Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents     cystoscopically after stone surgery?   "
115936|NCT01768351|"     Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism     in chronic kidney disease (CKD), and a large body of experimental data in animals confirms     the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the     benefits are greater with the newer vitamin D analog paricalcitol when compared with     calcitriol. A large gap exists in our knowledge between epidemiological studies in human that     demonstrate improved outcomes with vitamin D use and observations in preclinical studies     demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of     epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether     the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker     associated with worse outcomes in chronic kidney disease, and whether this effect not only     reflects the hyperparathyroidism correction, but is also dependent on the direct effects of     paricalcitol on erythroid progenitor cells.   "
115937|NCT01768338|"     The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see     what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.   "
115938|NCT01768325|"     The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing     it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.      This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved     by the U.S. Food and Drug Administration (FDA) for use.   "
115939|NCT01768312|"     The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic     solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12     weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety     in Moderate to Severe Dry Eye Disease.      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),     Non-anesthetic Schirmer test   "
115942|NCT01768273|"     The purpose of this study is to determine the safety and tolerability of PA-824 when given     with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a     clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of     midazolam, a known CYP3A substrate.   "
115943|NCT01768260|"     Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function     by improving the blood perfusion of eyes. The present study aims to investigate the effect of     EECP on Anterior Ischemic Optic Neuropathy.   "
115944|NCT01768247|"     A thin endometrium is one of the most difficult problems encountered in assisted reproduction     every day practice Regarding the proliferative phase, several ways of treatment have been     undertaken to circumvent thin endometrium trying to increase thickness with questionable     results.      The objective of the current study will be whether a daily dose of 150 IU (international     units) of human chorionic gonadotropin (HCG) for seven days concomitant with estrogen     administration in estrogen replacement cycles can increase the endometrial thickness and     improve pregnancy outcome.   "
115959|NCT01768052|"     The investigators plan to use optical brain imaging technology to observe patients with     current major depression before, during, and after repetitive Transcranial Magnetic     Stimulation (rTMS) clinical treatment. Clinical treatment involves 20-30 rTMS sessions over     the course of 4-6 weeks.      Our primary hypotheses are as follows:        1. Primary Hypothesis: In patients with a positive response to rTMS, the investigators will          observe an increase in the strength of connectivity as measured by fMRI among brain          regions in the cognitive control network after 4 weeks of treatment.        2. Secondary Hypothesis: Brain activation measured by functional Near-Infrared          Spectroscopy(fNIRS) in the dorso-lateral prefrontal cortex (DLPFC) during rTMS will          increase as the number of treatments increase. Detection of this increase in brain          activity at the beginning of the treatment help researchers and physicians assess          treatment response.   "
115945|NCT01768234|"     There is a large body of evidence from adult populations suggesting cognition in adults is     affected by hydration status. The few studies conducted in the global North in populations of     schoolchildren indicate that drinking water has an impact on pupil performance on basic     cognitive tasks. No studies assessing the impact of dehydration and cognition in     schoolchildren have been carried out in the global South, where access to water is the     poorest and dehydration prevalence is likely higher. This study will examine the effect of     drinking supplementary water during the school day on hydration status and on cognitive test     scores in schoolchildren in Mali, West Africa.      The investigators hypothesize that providing supplemental water will result in a decrease in     prevalence of dehydration in the study group and will result in an improved performance on     cognitive test scores.      Data will be collected from up to four purposively-selected schools in the Sikasso region of     Mali, from up to a total of 300 children. At each school pupils in grades 3-6 will be     eligible for recruitment. Research staff will explain the study to pupils at the school and     individually request informed oral assent for participation. A waiver of parental consent for     pupil interviews will be secured from the Ministry of Education. At each school, school     directors will be asked to sign in loco parentis (in the place of parent) on behalf of the     pupil participants.      Children that assent to participate in the study will be randomly allocated to the     intervention or control group. Data collection will take place at each school over two days     within a one-week period, with one study group tested on each of the two days. On the     intervention testing day, all study participants will receive supplementary water. On the     control testing day, no study participants will receive supplementary water. Testing     procedures in both groups is identical and will include a five-minute interview, two     cognitive testing sessions of 45 minutes each, and collection of two urine samples during the     day. None of these activities collect personal data or identifiers, and the urine sample will     not be stored.      All data collection will occur at the school and will be conducted by trained local     enumerators. There are no risks to participation other than a small amount of class time     missed by pupils, and great efforts will be made to minimize time outside of class.   "
115946|NCT01768221|"     This one-arm pilot study will evaluate the feasibility and acceptability of Caregiver     Outlook, a manualized chaplain-led intervention to improve the well-being of caregivers of     seriously ill patients.      Study Activities and Population Group:      The investigators anticipate enrolling 36 informal caregivers (adults) through DUMC providers     and/or self-referral. Potential subjects will be screened for study eligibility, consented if     eligible and interested, and one week later administered a baseline survey by phone. Next,     the chaplain-led intervention will be delivered by phone in three one-hour sessions, spanning     a one month window. After session 3, subjects will receive a check-in phone call to briefly     discuss their any additional thoughts, questions or concerns they may have. Sessions will be     audio recorded. After intervention completion, follow-up surveys will be administered by     phone at two points in time.      Data Analysis and Risk/Safety Issues:      This is a mixed-methods study involving qualitative thematic analysis and survey data,     collected from the adult caregiver subjects. There are no known physical risks to     participation, and the study team will work to ensure confidentiality and data     safety/integrity.   "
115947|NCT01768208|"     This study is an open-label, cohort study to evaluate the potential mechanisms of Saxagliptin     in the treatment of patients with type 2 diabetes (T2DM) using a comprehensive metabolomic     method, in combination with fingerprint analysis and target analysis. It is a sub-study of     STUDY: D168L00008.   "
115948|NCT01768195|"     The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg     Positive lymphoma patients treated with rituximab-based immunochemotherapy.   "
115949|NCT01768182|"     Objective: HIV infected individuals present a cluster of conditions that activate or injure     the vascular endothelium. The administration of folates may exert beneficial effects on     endothelial function in different populations at risk for cardiovascular disease. The aim of     the study was to determine the effects of 4 weeks folinic acid supplementation on forearm     vascular responses during reactive hyperemia in HIV-infected people under antiretroviral     therapy.      Methods: This was a prospective, randomized, double-blind, placebo-controlled trial to     compare the effects of 4 weeks daily ingestion of 5 mg folinic acid (n=15) or placebo (n=15).     Participants had to be on anti-retroviral therapy for at least 6 months before enrollment,     with undetectable viral load, and CD4 cell count > 200 cells/mm3. Vascular function was     evaluated with venous occlusion plethysmography at baseline and after 4 weeks, for the     determination of brachial artery reactive hyperemia, and after isosorbide dinitrate     administration   "
115950|NCT01768169|"     Increased understanding of the impact of long chain omega-3 PUFAs in combination with a low     fat plant-based diet will contribute to decelerating further escalation of the epidemics of     obesity, the (pre)metabolic syndrome, and T2DM in Taiwan.   "
115971|NCT01767896|"     The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture     derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine     (TIV) in elderly subjects.   "
116087|NCT01766375|"     This study was a multi-center, open, randomized-control study on the effects and safety of     idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on     the overall survival rate and disease-free survival rate of acute myeloid leukemia patient in     high-risk group over a period of 2 years.   "
115951|NCT01768156|"     HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may     have an advantage over the CA-125 assay in that it is less frequently positive in patients     with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of     ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up     period after treatment in metastatic ovarian cancer should be studied. It could be used in     patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be     compared with information provided by CA-125. The kinetics of HE4 values after treatment     should be also analysed to determine the role that HE4 could play in the detection of     recurrences during the follow-up of metastatic patients.   "
115952|NCT01768143|"     To measure competencies in propofol sedation for endoscopic procedures (NAPS)through     development, test and validation of a reliable assessment tool in a simulator setting.      Hypothesis: That the tool will demonstrate content and construct validity, ie. enable     reliable measuring of necessary competencies of different levels in a reproducible way.   "
115953|NCT01768130|"     The study will investigate the test-retest variability of thermal thresholds in patients with     persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller     delineated an area with cool sensory dysfunction on the painful site. In this area and in a     contralateral area as a control, 5 sites were outlined, including the point of maximum pain.     In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and     heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were     repeated after a 4-6 weeks interval.   "
115954|NCT01768117|"     This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086     vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6     schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work     directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086     vaccine development program. The study will provide descriptive safety and immunogenicity     data following vaccination of these individuals with bivalent rLP2086 vaccine.   "
115955|NCT01768104|"     The purpose of this study is to determine the efficacy and safety of endoscopic submucosal     tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the     treatment of upper gastrointestinal submucosal tumors.   "
115956|NCT01768091|"     The purpose of this study is to determine the efficacy and safety of peroral endoscopic     myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.   "
115961|NCT01768026|"     The objective of this study is to characterize the extent and severity of disease in subjects     with DEB and the progression of disease over a timeframe relevant to interventional studies.     The data from this study will be used to inform the study design and address statistical     considerations of future treatment protocols.   "
115962|NCT01768013|"     The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in     Japanese subjects with extensive psoriasis vulgaris.   "
115963|NCT01768000|"     The purpose of this study is to examine the effectiveness of family cognitive adaptation     training, including its impact on functioning and caregiver burden. Families that receive the     manual will be compared with a control group of families that will not receive the manual.     The larger goal is to add to the tools family members have access to better support their     family members with schizophrenia.   "
115964|NCT01767987|"     The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker     release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).   "
115965|NCT01767974|"     Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be     performed. The detection rates of EGFR mutation will be compared using paired samples.   "
115966|NCT01767961|"     This pilot clinical trial studies the modified barium swallow in measuring swallowing     function after surgery in patients with oropharyngeal cancer who have undergone surgery. New     diagnostic procedures, such as the modified barium swallow, may be effective in studying the     side effects of cancer therapy in patients who received treatment for oropharyngeal cancer   "
115967|NCT01767948|"     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations     change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic     impairment.   "
115968|NCT01767935|"     This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with     painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy     uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors.     Giving cryosurgery together with radiation therapy may kill more tumor cells   "
115969|NCT01767922|"     Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and     safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress,     physical and intellectual fatigue, pain perception, if present, and the impact on the quality     of life of 70 subjects included with 60 that can be evaluated.   "
115970|NCT01767909|"     An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can     arrest or reverse the disease at its earliest stages. The emotional and financial burden of     AD to patients, family members, and society is enormous, and is predicted to grow     exponentially as the median population age increases. Current FDA-approved therapies are     modestly effective at best. This study will examine a novel therapeutic approach using     intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful,     information gained from the study has the potential to move INI forward rapidly as a therapy     for AD. The study will also provide evidence for the mechanisms through which INI may produce     benefits by examining key cerebral spinal fluid (CSF) biomarkers and hippocampal/entorhinal     atrophy. These results will have considerable clinical and scientific significance, and     provide therapeutically-relevant knowledge about insulin's effects on AD pathophysiology.     Growing evidence has shown that insulin carries out multiple functions in the brain, and that     insulin dysregulation may contribute to AD pathogenesis.      This study will examine the effects of intranasally-administered insulin on cognition,     entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in     amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12 months     of treatment with INI compared to placebo, subjects will improve performance on a global     measure of cognition, on a memory composite and on daily function. In addition to the     examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to     examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4)     allele carriage predict treatment response.      In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months,     following an open-label period of 6 months where all participants will be given active drug.     The study uses insulin as a therapeutic agent and intranasal administration focusing on nose     to brain transport as a mode of delivery.   "
115972|NCT01767883|"     Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary     care offices and primary care physicians are generally not familiar with treatment     guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently associated     with co-morbidities that make effective treatment difficult due to complexity of care.     Availability of Clinical Decision Support (CDS) for CKD may help promote effective,     evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality     improvement and other interventions such as CDS plus practice facilitation may be needed.      Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based     guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice     guidelines that PCPs may use to enhance the care they provide to a difficult to manage     segment of the healthcare population.      Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE model     of practice change, versus CDS alone. The study aims to analyze differences in promoting     evidence-based care in primary care practices. Thirty-six practices will be recruited for     this study. Patient inclusion criteria: adult patients with estimated Glomerular Filtration     Rate (eGFR) of <60 and >15ml/min/1.73m2 confirmed with repeat testing over three or more     months. A process evaluation will be conducted between the CDS practices with facilitation     and the CDS only practices to assess clinical outcomes of CKD progression and all-cause     mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit ratio of CDS     alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to cost per     quality adjusted years of life. This study is funded by NIH NIDDK under R01 mechanism     starting on 07/01/2011 and ending on 06/30/2016.   "
115973|NCT01767870|"     The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal     immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced     colorectal neoplasia compared to colonoscopy.   "
115974|NCT01767857|"     The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix     (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard     therapy.   "
115975|NCT01767844|"     Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In     healthy individuals, food supplementation with creatine (Cr) increases muscle size and     improves physical function and quality of life. The aim of this study is to investigate     whether RA patients may benefit similarly.      50 participants will be given a food supplement to take for 12 weeks; this supplement will     either be creatine or a placebo (a regular fruit flavoured powder that has no benefits).      Over 12 weeks, body fat and muscle size (body composition), physical function, and fitness     (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will     be tested. In addition, quality of life questionnaires will be completed, disease activity     will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be     obtained, from those who volunteer to provide them, at baseline and post-treatment.   "
115976|NCT01767831|"     This study combines data collection and simulation-based education, and it will enroll up to     36 adults with T1DM who already have experience with insulin pump therapy and some experience     with a continuous glucose monitor (CGM). The study will first track participants for of a     3-day CGM-training period. The training period will be followed by a 1-week CGM monitoring     and CGM data collection period. Following the 1-week CGM monitoring-only portion of the     study, participants will begin the education intervention component of the study, referred to     as Insight-Based Online Learning Using Simulation and Education for Diabetes (iBOLUSED). The     education intervention component is 4 weeks in length. The intervention will involve daily     diary data upload and daily simulation-based feedback based on the collected diary data.     During the first week (and for up to 2 weeks) of the intervention, participants will view     glycemic outcome data that represents the participant's hypo- and hyperglycemic risk     throughout the day, based on the CGM data collected during the CGM monitoring period. In the     next 2 weeks of the intervention, participants will have an opportunity to interact with the     internet-based system using a simulation-based tool designed to provide insight to the     participant regarding the different effects of modifications to insulin therapy. Throughout     the educational intervention, participants will record diary data every day through the use     of a diary component in the internet-based system. Diary entries include data on meals,     physical activity, history of the insulin basal rate and insulin boluses given that day,     self-reported stress level, hypo- and hyperglycemic fear levels, and, if applicable,     menstrual cycle and any physical illness. Participants will also upload data from the CGM via     the Dexcom Data Manager 3 (DM3) software or the Dexcom Studio Software. Two assessments, one     prior to the intervention period and one following the intervention, will be administered to     gather relevant psychobehavioral information. Focus group sessions will be conducted at the     end of the study, which will allow for the collection of information regarding the     effectiveness of the Internet intervention and will provide insight for the design of future     studies. Parallel recording of CGM, insulin, and behavioral data, as well as psychometric     instruments, will produce a rich synchronized data set for each person that will facilitate     the development of personalized behavioral profiles that will be employed to provide     individualized feedback to educate participants. In particular, this study tests the use of     collected diary data to educate participants by describing glucose profile information and     presenting relevant data regarding: (1) hypo- and hyperglycemia risk zones throughout the     day, (2) insulin meal bolus information and associated glycemic outcome indices, and (3)     basal rate information with associated glycemic outcome indices.   "
115977|NCT01767818|"     The primary objective of this study is to obtain detailed clinical information and biologic     specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD.     Because of the inherent difficulties of using clinical outcome measures to assess disease     modification, the identification of biomarkers of PD is of paramount importance. The ideal PD     biomarker would be one that is easily assayed in a convenient biological sample, varies     proportionally with disease severity, is abnormal during the pre-symptomatic phase of the     illness, and is unaffected by drugs or other interventions used to treat PD. The existence of     a sensitive biomarker with these properties would enable much more effective disease     modifying research that would likely be able to take advantage of smaller and potentially     shorter trials.   "
115978|NCT01767805|"     The purpose of this study is to compare different culture conditions. The effect of the type     of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5%     versus 20%) will be evaluated on the embryo quality   "
115979|NCT01767792|"     To determine the hearing response rate at 24 weeks after treatment with bevacizumab for     symptomatic vestibular schwannomas (VS) in children and young adults with NF2.   "
115980|NCT01767779|"     To determine whether EEGs during infancy is a reliable biomarker to identify TSC patients     that will develop infantile spasms/epilepsy in the near future and thus are appropriate     candidates for an antiepileptogenic drug trial. Since not all patients with TSC develop     epilepsy, it would be useful to have a biomarker that could predict those patients destined     to have epilepsy and thus identify those TSC patients most appropriate for an     antiepileptogenic drug trial. A recent study suggests that treating TSC patients with an     abnormal EEG prior to onset of infantile spasms with vigabatrin may improve neurological     outcome, but the use of EEG as a reliable biomarker of future epilepsy has not been     rigorously validated. In this specific aim, we will test the reliability of EEG in predicting     future development of infantile spasms or epilepsy in TSC patients during the first year of     life.   "
115981|NCT01767766|"     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients     with advanced hematologic malignancies.   "
116011|NCT01767376|"     The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the     meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of     the two vaccines given separately in healthy adolescents and young adults.   "
117195|NCT01751932|"     The purpose of this study is to assess the accuracy of two continuous glucose monitoring     devices (the Dexcom G4 Platinum and Medtronic Enlite systems) in patients with type 1     diabetes mellitus.   "
115982|NCT01767753|"     Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in     early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently     during the nocturnal period than during the diurnal period in a group of medically-treated     patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT     effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the     24-hour effect of SLT in untreated glaucoma patients.      The purpose of this study is to assess the changes of IOP over a 24-hour period in patients     with glaucoma undergoing SLT.   "
115983|NCT01767740|"     The primary objective of this study is to obtain safety data on the use of the ULTRABRAID     PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS     SUTURE in comparison to the ULTRABRAID SUTURE in patients undergoing rotator cuff repair.   "
115984|NCT01767727|"     Multiple finger defects are common in hand trauma and result in functional disability. These     injuries are often complex and severe, and thus reconstructive alternatives are limited. In     this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the     digital artery, for reconstruction of multiple finger defects. At the final follow-up, we     would evaluate the efficacy of this technique.   "
115985|NCT01767714|"     The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only])     plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6     CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus     placebo.   "
115986|NCT01767701|"     The purpose of this study is to determine whether raltegravir is effective in preventing     progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced     MRI.   "
115987|NCT01767688|"     This study will investigate and compare the pharmacokinetics of a single 25-mg dose of     MK-3102 in participants with moderate hepatic impairment and matched healthy participants.     The primary hypothesis is that in participants with moderately impaired hepatic function, the     area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar to     that observed in healthy matched control participants following a single 25 mg oral dose of     MK-3102. Specifically, the true ratio (moderately impaired hepatic function patients/healthy     matched control subjects) of geometric means for AUC0-∞ is no greater than 2.   "
116009|NCT01767402|"     The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the     GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy     elderly population aged 18-45 years of age.   "
116092|NCT01766310|"     The purpose of the present study was to determine whether folic acid supplementation could     reduce plasma homocysteine in obese children and to determine the association between dietary     folate, serum folate and homocysteine level through the randomized double blinded placebo     controlled trial.   "
115988|NCT01767675|"     The purpose of this study is to see if the investigators can improve the treatment of this     type of cancer. They want to find out what effects, good and/or bad, giving heated     chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has     on the patient and this type of cancer.      The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of     chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to     get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and     Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary     peritoneal cancer.   "
115989|NCT01767662|"     The purpose of this study is to determine effectiveness of parents' manipulation in newborn     with talipes calcaneovalgus over observation group.   "
115990|NCT01767649|"     The purpose of this study is to identify molecules produced specifically by the cells from     the chorionic membranes of the materno-fetal interface (the water bag) sign for the     activation of preterm labor.   "
115991|NCT01767636|"     This phase II trial studies how well pazopanib hydrochloride works in treating patients with     kidney cancer that has spread to other places in the body (metastatic). Pazopanib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Pazopanib hydrochloride may also stop the growth of kidney cancer by blocking     blood flow to the tumor.   "
115992|NCT01767623|"     This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the     pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive     cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function)     or 720 mg (severe hepatic impairment) orally twice daily (BID) on Days 1 to 20 (morning dose)     and from Day 27 onward until disease progression or unacceptable toxicity occurs.   "
115993|NCT01767610|"     To develop combination product of micronized fenofibrate plus pitavastatin, we would like to     evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic     characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized     fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae     Pharm. through 3 period by separately or combinedly.   "
116012|NCT01767363|"     This retrospective cohort study will assess the association of benign prostatic hyperplasia     (BPH) treatment (5-alpha reductase inhibitors (5ARI) and alpha-blocker medications) with the     occurrence of prostate cancer related mortality. This study will also assess a number of     secondary endpoints including prostate cancer mortality or metastatic prostate cancer, and     all cause mortality.   "
116013|NCT01767350|"     The long-term success of solid organ transplantation is largely dependent on the efficacy of     immunosuppressive medication. Unfortunately, for the most important agents the correct drug     levels are difficult to attain, with potential severe consequences of drug under- or     overexposure. In addition there is a large variation in dose requirements within and between     different subjects. Clinical studies have demonstrated that a better control of drug exposure     can improve outcome. A large set of patient characteristics appear important in determining     dose requirements in adults, in particular genetic variation in genes involved in drug     metabolism. In children relative dose requirements are increased compared to adults, but is     not known why and the role of pharmacogenetic variation has not been described.      Our study aims to describe relative dose requirements in children after solid organ     transplantation with the help of clinical and laboratory data obtained during regular     hospital visits (retrospective). In addition we will assess their genotype for genes involved     in the metabolism of immunosuppressives.   "
115994|NCT01767597|"     With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year,     hepatitis B is currently a frequent and potentially severe disease in France, despite efforts     towards prevention and effective care.      In terms of prevention, France has very low immunization coverage (27.7%) and a high     percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly     explained by poor knowledge of hepatitis B infection in the general population and an     underestimation of the health impact of hepatitis B by doctors and health officials. Until     recently, there have been no national guidelines governing its implementation (which is     variable depending on the structures where screening is performed) and an insufficient     evaluation of screening practices. Thus, data on the severity of liver disease, indications     for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized     people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely,     particularly to address the issue of people who do not come back and collect their results     and to better adapt counselling, their usefulness to detect of hepatitis B virus has not     been evaluated to date.      The main objective of the Optiscreen B Study is to determine the benefit, if any, of using     rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B.     Individuals risk of HBV-infection will be randomized into 2 groups, one group for which     screening will be performed by usual serological test and a second group for which screening     will be based on rapid tests. Centers will be selected to represent a diverse range of health     centers whose aims include screening, prevention and/or vaccination.   "
115995|NCT01767584|"     The objective of this study was to confirm if two formulations of cephalexin tablets are     bioequivalent.      Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1     g Cephalexin; Eli Lilly). The single dosage was one tablet.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 26 healthy volunteers, both genders, adults between 18-40     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
115996|NCT01767571|"     The objective of this study was to confirm if two formulations of cephalexin suspension are     bioequivalent.      Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product     Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 10 ml of suspension for     Ceporex and 20 ml of suspension for Keflex® .      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 28 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
115997|NCT01767558|"     PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post     market clinical study conducted in Europe. The purpose of the study is to evaluate     asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial     fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.   "
115998|NCT01767545|"     To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with     bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated     with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive     bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with     dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly     intervals. The primary endpoint was BCVA at twelve months.   "
116029|NCT01767142|"     Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a     belt applicator. Applicator design and treatment parameters will be evaluated.   "
116030|NCT01767129|"     To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg     dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of     levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).   "
115999|NCT01767532|"     The objective of this study was to confirm if two formulations of cephalexin suspension are     bioequivalent.      Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product     Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 28 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
116000|NCT01767519|"     A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with     overactive bladder (OAB) and urinary incontinence.   "
116014|NCT01767337|"     This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of     saline from the FLUGEN 101.2 investigational microneedle-based device.   "
116015|NCT01767324|"     The goal of this exploratory study is to select the optimal body site for intracutaneous     delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.   "
116016|NCT01767311|"     This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study     using a Bayesian design with response adaptive randomization across placebo or 5 active arms     of BAN2401 to determine clinical efficacy and to explore the dose response of BAN2401 using a     composite clinical score (ADCOMS). BAN2401-G000-201 is an 18-month study in which 3 dose     levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of     participants and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of     participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI)     due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim     analyses will be conducted to continually update randomization allocation on the basis of the     primary clinical endpoint.   "
116017|NCT01767298|"     This study was conducted to compare the rate and extent of absorption of valsartan and     hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose     of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).   "
116001|NCT01767506|"     Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following     repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as     anticipated. The investigators propose to conduct a clinical trial in 52 communities in     Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that     all communities would have annual rounds of MDA if infection is greater than 1% or follicular     trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment     program to identify and treat new families and families who travel after mass treatment.     Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will     be reinstated if infection re-emerges to 6% or more. The proportion of communities that are     able to stop mass treatment will be compared in the group of communities randomized to mass     treatment plus the newcomer/traveler treatment program compared to the communities randomized     to mass treatment alone after 24 months.      At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight     (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months     will be surveyed at 30 months. At risk of trachoma re-infection communities have C.     trachomatis infection rates less than or equal to 1% or TF < 5% at the time of the 18 month     survey. Surveillance of communities for families that meet the newcomer or traveler status     will extend 6 months beyond the 24 month survey to 30 months in the intervention communities     only. A survey of sentinel children in the intervention and control communities at 30 months     will be conducted to assess the level of trachoma and infection in all 38 communities at risk     of trachoma re-emergence.   "
116002|NCT01767493|"     The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron     emission tomography (PET) for assessment of demyelination in the patients with relapsing     remitting multiple sclerosis.   "
116003|NCT01767480|"     Robot-assisted training (RT) devices developed to date have a significant impact on stroke     rehabilitation. Several research groups have developed the robotic devices and examined their     efficacy on improving upper limb function after stroke. All these robotic devices have been     applied in stroke rehabilitation and their efficacy are evaluated, but the scientific     evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the     impact on physiological responses is still lacking.      This trial is to examine (1) the immediate effects of treatment intensity in RT on     sensorimotor impairments and functional performance in patients with subacute stroke; (2) the     long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation;     and (3) the effects of RT on cortical/movement reorganization as well as on the physiological     markers of inflammation, oxidative stress, and erythrocyte deformability. These overall     findings will help better understanding of the efficacy of RT on functional outcomes, brain     and movement reorganization, and physiological markers.   "
116004|NCT01767467|"     The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals'     vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will     evaluate safety-related events and antibody and cellular immune responses to the study     vaccine, as compared to placebo.   "
116005|NCT01767454|"     This is an open-label, multi-center, dose-finding Phase 1 study that will enroll subjects at     least 18 years old with unresectable or metastatic melanoma and BRAF V600 mutations. The     primary objective of the study is to describe the safety for the doublet therapy (dabrafenib     and ipilimumab) and the triplet therapy (dabrafenib/trametinib and ipilimumab). Preliminary     efficacy data will also be collected. Subjects will be assigned to receive either the doublet     combination (dabrafenib and ipilimumab) or the triplet combination (dabrafenib, trametinib,     and ipilimumab). Subjects will be enrolled to dose-finding cohorts in the doublet combination     (dabrafenib + ipilimumab) in a sequential 3+3 fashion. Following establishment of a dose for     the doublet combination, an expansion cohort will be opened. At the same time, enrollment to     dose finding cohorts for the triplet combination (dabrafenib + trametinib + ipilimumab) will     begin in a sequential 6+6 fashion. Enrollment into triplet cohorts will take priority when     both the doublet expansion arm and the triplet dose-finding arm are open for enrollment at     the same time. Approximately 9-24 subjects will be enrolled to the dose finding portion of     the study. Approximately 30 subjects will be enrolled to doublet expansion cohort and 30     subjects will be enrolled in the triplet expansion cohort. A two-week run-in period without     ipilimumab will be followed by 4 intravenous doses of ipilimumab at the recommended dose and     schedule. Oral daily dosing of dabrafenib or dabrafenib + trametinib will continue from the     two-week run-in, through combination with ipilimumab, and post-ipilimumab until no longer of     clinical benefit, in the opinion of the treating physician, or until unacceptable AE or death   "
116006|NCT01767441|"     Bariatric surgery can lead to improvement or even resolution of type 2 diabetes Mellitus     (T2DM) with the spectrum of responses depending also on operation procedures. However, many     mechanisms of metabolic action of different surgical techniques still are unclear.      The aim of this study is to provide a better understanding of the effects of three types of     bariatric surgery (lap banding, gastric bypass and sleeve gastrectomy) on beta-cell function     and incretin secretion. A mixed meal tolerance (MMT) test will be performed before and 1 and     12 months after surgery to assess beta cell adequacy and glucagon-like-peptide-1     (GLP1)/glucose-dependent insulinotropic polypeptide (GIP) bioavailability.   "
116007|NCT01767428|"     A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast     release in fasted state.   "
116008|NCT01767415|"     The purpose of this study is to investigate whether stereotactic indigo carmine injection can     safely increase the extent of tumor resection.   "
116010|NCT01767389|"     This study will assess the utilization patterns (adherence, source of the index antidiabetic     agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1)     receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors     (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute     pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors,     separately, in comparison to other ADAs.      The proposed study will help in understanding the treatment utilization patterns and the     incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists.     This study differs from previous observational studies by including both exenatide and     liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011).      This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters)     commercial health insurance database from 2005-2011.   "
116018|NCT01767285|"     The investigators are examining if there is a difference in continuation rates of the     etonogestrel contraceptive implant between women who have the device placed immediately after     delivery, before leaving the hospital, and women who have the device placed at the routine     6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30     in each group. All participants will follow-up at the same postpartum clinic 6 weeks after     delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete     a brief survey. The investigators hypothesize that continuation rates of Implanon will be     higher in the immediate postpartum placement arm than in the delayed placement arm.   "
116019|NCT01767272|"     The present study was adopted to evaluate the pharmacokinetics and dose linearity of     fexofenadine after oral administration.   "
116020|NCT01767259|"     This study was conducted to compare the rate and extent of absorption of valsartan and     hydrochlorothiazide following oral administration as a fixed dose combination tablet and     concomitant administration of the individual drugs under fasting conditions in healthy     Egyptian subjects. The study was extended to investigate any potential reaction between VAL     and HCT.   "
116031|NCT01767116|"     The purpose of this study is to evaluate the safety and antiviral activity of     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin     (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without     cirrhosis.   "
116032|NCT01767103|"     Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the     effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide     metabolite following a single oral dose of 33mg/kg Ferriprox®.   "
116033|NCT01767090|"     The main objective for this study is to assess the efficacy and dose-response relationship of     ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to     assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of     ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of     endometriosis associated pain and 24-week safety and tolerability of ASP1707.   "
116034|NCT01767077|"     Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on     blood lipid profile, vascular function, insulin sensitivity, inflammation and gene     expression. Overweight subjects will be randomized to one of 2 groups with different types of     dairy products: 1)butter oil; 2) cream (milk fat with MFGM).   "
116021|NCT01767246|"     Patients who are diagnosed with Patellofemoral Pain Syndrome (PFS) and present to our clinic     will be offered the opportunity to participate in the study. If they consent to be in this     study they will randomized into 2 treatment groups. The experimental treatment group will be     treated according to the novel PFS treatment algorithm. The control group will receive     treatment that would be considered standard physical therapy care. To apply standard physical     therapy care in a standardized manner the investigators are using a multimodal treatment     approach that has been previously shown by Lowry to be beneficial in the treatment of PFS.     Both groups of subjects will be seen 2 times per week for a maximum of 12 visits. Patients     can be discharged early if they no longer report pain or impaired function on the Anterior     Knee Pain scale.      The purpose of this study is to see if patients with patellofemoral pain syndrome treated     with the experimental Patellofemoral treatment algorithm experience significant improvements     in function, pain and the number of treatment sessions compared with a previously researched     multimodal approach to the treatment of patellofemoral pain.      The secondary objective of this study is to examine results to determine if a full randomized     controlled clinical trial of the PFS algorithm is justified.      The investigators hypothesize that utilization of the Patellofemoral syndrome treatment     algorithm with evaluation and treatment of patients diagnosed with PFS will lead to     significant improvements in function, pain and the number of treatment sessions when compared     to previously researched treatment of PFS.   "
116022|NCT01767233|"     Since the majority of patients with necrotizing pancreatitis will experience a leak from the     pancreatic duct during their course of disease resulting in intra- and peripancreatic fluid     collections, it is reasonable to hypothesize that placement of a ductal stent may prevent     some of the late complications and morbidity associated with pancreatic necrosis. This     prospective, randomized, controlled multicenter trial investigates the role of early     prophylactic ductal stenting in acute necrotizing pancreatitis.      The purpose of the study is to determinate the safety and feasibility of early prophylactic     pancreatic duct stenting in necrotizing pancreatitis in reducing complications, length of     stay in hospital and in in-tensive care unit compared to the traditional treatment.   "
116023|NCT01767220|"     A significant portion of patients with cardiac diseases like coronary artery disease (CAD),     dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC)     develops ventricular tachycardia (VT). The standard ablation procedure is carried out from     endocardial only. In 30% of patients treated this way a successful ablation is not possible.     In these cases the scar areas are mostly located in the outer layer of the myocardium.     Ablation is feasible only if the catheter is placed in the epicardial space to reach the     surface of the heart muscle. In the past this type of ablation was performed as a second     procedure in case of recurrent VTs after unsuccessful endocardial ablation.      This prospective randomized trial compares the standard ablation procedure (endocardial     ablation only) with a new strategy. This means in a single procedure the scar areas     responsible for VT are marked and obliterated from endocardial as well as from epicardial.     The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation     only.      40 patients will be enrolled. They will be randomized 1:1 in the study arms strategy 1     which is standard endocardial ablation and strategy 2 which is endo- and epicardial     ablation.      At least 12 months are planned for enrollment. The study is closed if the patient last     enrolled has completed the 12-months-follow up. Follow up visits are scheduled 3, 6 and 12     months after the ablation procedure. Recurrence of VT is monitored by ICD (implanted     cardioverter defibrillator) interrogation.      Both ablation strategies are well established and conducted with standard equipment. The     methodology of this study does not contain any experimental approaches. The standard     insurance coverage of the hospital is guaranteed for all enrolled patients.   "
132869|NCT01545791|"     This study is conducted in Europe. The aim of the study is to observe the safety of insulin     detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.   "
116024|NCT01767207|"     Patients referred to pediatric rehabilitation services have often cognitive     deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when     designing treatment plans.      Children and adolescents with cognitive deficits and intellectual disabilities (ID) have a     high risk of developing mental health problems. There is lack of knowledge about such     comorbid mental disorders in the health service. There are also few validated instruments for     assessing mental disorders among children and adolescents with cognitive deficits and ID both     in Norway and abroad.      The main aims of the current multicentre study are to:      Investigate psychometric properties of different psychiatric instruments for children and     adolescents. Investigate change and stability of symptoms over time. Investigate user     satisfaction. The study will include Pediatric Rehabilitation Services at hospitals in     Tromsø, Hammerfest and Bodø and will include in total 320 patients aged 4 to 18. We will use     information from parents, teachers and patients, in addition to clinician-rated measures.     Patients will be assessed at intake and after six months. We have conducted a pilot study in     the period from 2012 to 2013.   "
116026|NCT01767181|"     EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to     investigate the effects of 12 weeks of randomized timed light therapy or timed physical     exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral     circadian rhythms and cardiometabolic function in healthy night shift workers.   "
116027|NCT01767168|"     The purpose of this study is to test the hypothesis that a preoperative test of pain     modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk     score for the prediction of persistent pain will be developed from parameters available     before surgery.   "
116028|NCT01767155|"     Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy     and safety of AEZS-108 and doxorubicin. The study will include about 500 patients with     endometrial cancer resistant to platinum/taxane-based chemotherapy.   "
116035|NCT01767064|"     Inappropriate antibiotic prescribing for acute respiratory infections (ARIs) persists despite     decades of intervention efforts. Negative outcomes of inappropriate antibiotics include     increased costs of care, adverse drug reactions, and rising prevalence of     antibiotic-resistant bacteria. To address this public health problem, we apply the principles     of commitment and consistency in an effort to influence clinician decision-making through the     implementation of a low-cost behavioral nudge in the form of a simple public commitment     device. Clinicians were asked to post in their exam room a signed letter indicating their     commitments to reducing inappropriate antibiotic use for ARIs. Our hypothesis is that     clinicians displaying the poster-sized commitment letters will decrease their inappropriate     antibiotic prescribing for ARIs as compared to clinicians in the control condition (with no     posted letter).   "
116036|NCT01767051|"     Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous     clinical presentation varying throughout life, from birth up to post-menopause. Although     mostly known for its reproductive consequences, PCOS is associated with metabolic     abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are     considered to be at risk for early insulin resistance, leading to development of PCOS and     metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are     considered as states of low- and pro-inflammation associated with endothelial dysfunction. In     addition, it has been shown that endothelial dysfunction develops from the first decade of     life in response to genetic and environmental risk factors. Therefore, offspring of women     with PCOS may be at increased risk for vascular disease later in life. Moreover, some     evidence suggests that early life respiratory disease also contributes to later life     cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a     systematic follow up of children born form PCOS mothers has not been performed yet. the     investigators propose a systematic evaluation of cardiometabolic and pulmonary health     characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A     saliva sample will be performed to determine the biochemical androgenic status of the     children. Mothers of these children have undergone standardized phenotyping prior to     conception; the investigators will therefore be able to correlate the metabolic status of the     mother around the time of conception and the cardiometabolic and pulmonary health of their     offspring.   "
116037|NCT01767038|"     Patients with retinal detachment do not always recover good visual function. Sometimes simple     causes are responsible. Other causes can only be discovered thanks to high-resolution imaging     provided by the latest generation of OCT.      This study is possible thanks to surgical teams who have a strong recruitment potential, with     the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude FRIENDS)     to define more strict intervention criteria. The principal objective of this study is to     better define with regard to time:        -  The onset of surgically curable or transient macular affections, and losses in visual          acuity that can be qualified as explained        -  But above all to better understand the relationships between anatomical analyses          obtained using OCT and autofluorescence and functional analysis using visual acuity and          microperimetry.        -  In the near future, two techniques (OCT and microperimetry) will certainly become          essential tools in the evaluation of macular function. Better understanding of these          relationships is the first necessary step in any study concerning the therapeutic          prevention of retinal lesions related to retinal detachment: This study will make it          possible to define criteria for the evaluation of anatomical and functional recovery,          their relationship with each other and finally their evolution over time. This is an          essential first phase before possible therapies can be evaluated.   "
116038|NCT01767025|"     In this study, the influence of oxytocin on automatic imitation behaviour is investigated.     Healthy adults will be administered with either oxytocin or a placebo, and will perform an     imitation-inhibition task (as a measure of automatic imitation behaviour). To determine the     specificity of the oxytocin effect, an unrelated cognitive task (Stroop task) will also be     presented.   "
116088|NCT01766362|"     The aim of this study is to show that PRPC performed in a single session using a Pascal laser     leads to better management of the disease (better rate of regression of neovessels, lower     risk of a loss of visual acuity in the long term related to macular edema), a saving of time     and better comfort for both patient and doctor.   "
132870|NCT01545778|"     The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate     release with the risk of shopping behavior of oxycodone immediate release.   "
116039|NCT01767012|"     Modern phacoemulsification techniques have made cataract surgery safe and efficient over the     past several decades. Although the phacoemulsification procedure has improved greatly,     cataract surgery still involves trauma. One of the surgical traumas during cataract surgery     is the direct trauma of the anterior uvea, resulting in a later chronic immune reaction of     the uvea to the implanted intraocular lens (IOL). 1 The breakdown of the blood-aqueous     barrier (a measure of the uveal reaction) clinically presents as flare in the anterior     chamber. 2 Petternel et al. 3 explained that the protein content of the aqueous humor may     mainly arise from the iris root and iris vessels in the anterior chamber. The peak of this     flare and cell intensity in the anterior chamber was shown to be reached during the first two     days after cataract surgery 4 and flare levels were back to the preoperative values about one     year after cataract surgery. 5, 6 Influencing factors are surgical technique 7, perioperative     treatment 8, IOL biomaterial and design 9 and host reaction to the IOL.      In this study the otherwise same IOL concerning material and design, but one with a new     surface modification will be compared to assess the influence on aqueous flare and cell     intensity in the anterior chamber. The Polylens (Polytech, Rossdorf, Germany) is a     hydrophobic acrylic single-piece open-loop IOL and is available with the standard surface and     a novel modified surface.      To assess the efficacy of the newly modified surface of the Polylens IOL compared to the same     IOL without a modified surface concerning flare and cell intensity in the anterior chamber as     well as cellular components on the IOL surface and lens epithelial out-growth from the rhexis     after cataract surgery in eyes of patients with diabetes mellitus and pseudoexfoliation     syndrome, which typically have a higher incidence of post-operative intra-ocular     inflammation.   "
116040|NCT01766999|"     Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic     surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with     large volumes of a solution which also contain local anesthetics. However local anesthetics,     can also lead to a marked production of methemoglobin. New generation pulse oximeters are     able to measure SpMetHb non-invasivly.      The aim of this study is:        1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at          increased risk for methemoglobinemia.        2. to illustrate MetHb concentrations over a course of 24 hours after a liposuction          employing tumescent anesthesia has been carried out.   "
116041|NCT01766986|"     Background: Owing to controversial staging and classification of adenocarcinoma of the     oesophagogastric junction (AOG) before surgery, the choice of appropriate surgical approach     remains problematic.      In a retrospective study, preoperative staging of AOG and the impact of preoperative     misclassification on outcome were analysed. Methods: Data from patients with AOG were     analysed from a prospectively collected database with regard to surgical treatment,     preoperative and postoperative staging, and outcome.   "
130838|NCT01572441|"     The purpose of this study is to observe parent-adolescent interactions and to examine the     parenting behaviors and adolescent emotional and physiological responses that are associated     with youth's substance use.   "
116042|NCT01766973|"     Recent evidence suggests that chronic pain is associated with abnormal connectivity between     brain regions associated with the processing of pain. We aim to test the diagnostic power of     resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic     back pain. Using new methods of image acquisition and analysis we aim to develop a     computational method to correctly classify patients and matched control subjects.   "
116043|NCT01766960|"     One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD).     NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people     have this disease, the change in how the liver handles drugs and compounds in the body has     not been studied. The purpose of this study is to investigate how advanced NAFLD changes the     ability of the liver to handle both endogenous and exogenous compounds.   "
116044|NCT01766947|"     Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous     humor via the trabecular meshwork through the Schlemm's canal towards the systemic     circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose     of glaucoma management is to lower IOP in order to prevent progression of the optic     neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug     therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses     despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating     surgical procedure for the treatment of open angle glaucoma that allows the enhancement of     the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular     meshwork. DS was shown to achieve a good control on IOP over the long term.      The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with     Triggerfish in patients with POAG before and after DS.   "
116045|NCT01766934|"     Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy     unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.   "
116046|NCT01766921|"     Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived     influenza vaccine in elderly subjects   "
116047|NCT01766908|"     This is an experimental research study for pregnant women between 23 and 37 weeks age of     gestation who will be having a baby sooner than term. This study is to learn if waiting 20,     40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her     outcome and overall health. Benefit to the baby may come by increasing the amount of blood in     the baby's body, reducing the need for possible transfusion later, and possible prevention of     other complications caused by too little blood in the baby. Possible reduction of cerebral     palsy may be realized by a longer interval for cord clamping.   "
116048|NCT01766895|"     The linkage between viral hepatitis and renal failure is complex. The current study aims to     exlore the long-term prevalence of viral hepatitis among uremic patients in Taiwan   "
116049|NCT01766882|"     The purpose of this study to conduct a pilot, randomized trial in stable HD patients to     evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight,     combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure     on hydration/volume status and blood pressure (BP) control.   "
116084|NCT01766414|"     Excessive inflammation is associated with tissue damage caused by over-activation of the     innate immune system. This can range from mild disease to extreme conditions, such as     multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked     contrast to adaptive immunity which is very sensitive to immune modulators such as steroids,     the innate immune system cannot be sufficiently targeted by currently available     anti-inflammatory drugs.      The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human     endotoxemia model can modulate the innate immune response.      In this study, human endotoxemia will be used as a model for inflammation. Subjects will,     prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be     sampled to determine the levels of markers of the innate immune response.   "
116050|NCT01766869|"     The investigators' goal is to develop a non-selective and non-invasive procedure to identify     aggressive tumors and simultaneously identify their exact location in Prostate cancer     patients undergoing radical prostatectomy by combining multiparametric MRI and machine     learning techniques. The combination of multi-parametric MRI and machine learning (validated     using histopathology) can lead to increased sensitivity and specificity of cancer foci in the     prostate, and help in isolating aggressive from indolent tumors. This increased sensitivity     and specificity may eventually lead to: a) a reduction in the number of patients that undergo     unnecessary treatment, and b) enhance current treatment options by enabling the use of     focused therapies. The investigators will recruit 15 patients with prostate cancer that are     currently scheduled to undergo radical prostatectomy into the study. All patients will obtain     an advanced MRI study prior to the radical prostatectomy. MRI scans will include a)     high-resolution volumetric images using T1 and T2-weighted imaging, b) vascular images using     dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using     diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging.     Following radical prostatectomy, a pathologist will grade the prostatectomy specimens based     on standard of care (Gleason grading system). Correlations will be generated between the     parameters obtained from scans and from clinical assessments.   "
116051|NCT01766856|"     This study will determine whether the likely success of closing a hole in the eardrum can be     predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that     connects the back of the nose with the middle ear. When a person goes up in an airplane and     their ears pop or when one yawns and their ears pop, that is the Eustachian tube opening.     The Eustachian tube is responsible for keeping the air pressure in the middle ear the same as     in the environment and keeping the middle ear free of fluid. It is thought that in children     with middle-ear disease, the muscles that open the Eustachian tube do not work very well;     this seems to get better in many children as they get older. It is thought that poor     Eustachian tube function is the cause of failures when holes in the eardrum are patched and     also for the recurrence of fluid in the middle-ear. The primary goal of this study is to see     whether it can be predicted, based on testing Eustachian tube function before surgery,     whether patching the eardrum will be successful and whether fluid will come back in the ear     after it is patched.   "
116052|NCT01766843|"     The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler     with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.   "
116072|NCT01766570|"     The purpose of this study is to measure the beneficial effects of an optimized berries     extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including     a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose     tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress     markers.   "
116078|NCT01766492|"     Quality of life data following SBRT for prostate cancer has been obtained in only a small     numbers of patients. A prospective study using validated quality of life questionnaires is     needed to determine outcomes after treatment with SBRT. Our study will be the first essential     step in developing a better evidence base on the comparative risks and benefits of SBRT     treatment with regards to quality of life assessment and outcomes.   "
116053|NCT01766830|"     Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the     availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be     a thorny problem for travel physicians. In developing countries, the scarcity of skilled     personnel and adequate laboratory facilities makes the differential diagnosis of fevers even     more complex. Health care workers must often rely on syndrome-oriented empirical approaches     to treatment and might overestimate or underestimate the likelihood of certain diseases. For     instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of     persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major     disability. These diseases are however rarely diagnosed at primary health care (PHC) level.     The difficulty in establishing the cause of febrile illnesses has resulted in omission or     delays in treatment, irrational prescriptions with polytherapy, increasing cost and     development of drug resistance.      In resource-limited settings, clinical algorithms constitute a valuable aid to health     workers, as they facilitate the therapeutic decision in the absence of good laboratory     capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of     NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain     empirical. Besides, they rarely take into account local prevalence data, do not adequately     represent the spectrum of patients and differential diagnosis at the primary care level and     often have not been properly validated. The purpose of the study is to develop evidence-based     Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent     fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.   "
116054|NCT01766817|"     The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once     daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in     forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary     fibrosis (IPF).   "
116055|NCT01766804|"     The aim of the present study is to evaluate the ability a colostrum containing diet to limit     gastrointestinal toxicity including chemotherapy induced inflammation in children treated for     acute lymphoblastic leukemia.   "
116056|NCT01766791|"     A plethora of trials reported the positive effect of resistance exercise on functional and     morphological parameters. Although a large amount of the studies used suboptimum devices and     obsolete methods the results of these older studies were still considered as golden standard.     The aim of the present study is thus to determine the proper effect of different resistance     exercise protocols with and without adjuvant protein supplementation on functional and     morphological muscle and body composition parameters in male untrained subjects 30-50 years     old under special regard of modern medical imaging and segmentation technologies.      Our general study hypothesis is that HIT-resistance exercise significantly impact relevant     muscular parameters of the upper leg.   "
116057|NCT01766778|"     The purpose of this study was to observe change of HbA1c over time from baseline to month 12.     The ultimate goal of this study was to provide a local reference value to the physicians &     patients in the future when they consider initiating Vildagliptin and taking balance between     efficacy, compliance, risk factors, convenience and medication cost.   "
116058|NCT01766765|"     Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time     to AC is associated with worse survival. However, most clinical trials mandate that AC is     still to commence within 6 to 8 weeks after surgery consideration for malnutrition,     postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube     for enteral nutrition is a common component of these procedures, as a result of superior     postoperative organ function, decreased infection rates, and a greater likelihood to complete     AC with enteral nutritional support.      Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing     morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital     stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in     reductions in total complications compared with traditional postoperative feeding practices     and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube     routine placement and combination with FTS is still being debated. Besides, there remains     some controversy over the optimal combination of nutrients and duration and timing and routes     of feed administration.      The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN)     following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and     minimizes time to AC when compared with FTS with early oral nutrition (EON).   "
116059|NCT01766752|"     Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic     management in non-critically ill patients with type 2 diabetes at the general ward   "
116060|NCT01766739|"     The purpose of this study is to test the safety of the GL-ONC1 vaccinia virus at different     dose levels. The investigators want to find out what effects, good and/or bad, it has on the     patient and the malignant pleural effusion. A malignant pleural effusion is a build up of     fluid in the chest cavity cause by the cancer.   "
116061|NCT01766726|"     The main aims of this study are to determine whether: a) ART-naïve HIV+ subjects have     increased artherosclerotic plaque inflammation/vulnerability, b) newly-initiated     QUAD/Stribild therapy will decrease plaque inflammation/vulnerability in these subjects, and     c) QUAD/Stribild therapy will improve indices of immune dysregulation and lipid dysfunction     as a mechanism of improved plaque inflammation/vulnerability. Parameters of lipid and immune     function will also be assessed in healthy control subjects, for comparison.   "
116073|NCT01766557|"     The objective of our study is to determine the effects of fish protein on insulin sensitivity     in PCOS women with insulin resistance, and its mechanism of action on glucose and endocrine     metabolism. Our working hypothesis is that dietary fish protein improves insulin sensitivity,     glucose tolerance, and related plasma endocrine and lipid abnormalities in PCOS women by     restoring secretory β-cell function and insulin signaling to the PI 3-kinase activity/Akt     pathway. We further hypothesize that fish protein will improve cycle regularity and ovarian     function.   "
116074|NCT01766544|"     This is a report of a protocol developed to improve asthma and COPD care in a primary care     setting. The study was approved by an Ethics Committee and support by the Canadian Thoracic     Society through an unrestrictive grant from GlaxoSmithKline. However, the study could not be     done and the investigators report why, discussing the difficulties to perform such study.     This information should be very useful to investigators planning this sort of study.   "
116062|NCT01766713|"     Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from     simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver     disease that can lead to cirrhosis and liver-related mortality in persons who drink little or     no alcohol. Nonalcoholic steatohepatitis (NASH) represents the more severe end of this     spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation     with or without fibrosis. The etiology of NASH is not completely understood, but it is often     associated with obesity, type 2 diabetes, hyperlipidemia and insulin resistance.     Lipotoxicity, insulin resistance and oxidative stress appear to be central to the     pathogenesis of NASH. Currently, there is no FDA approved treatment for NAFLD/NASH. Weight     loss and exercise are the recommended but often difficult maintain these lifestyle changes in     the long term and therefore therapeutic agents have been investigated. Ezetimibe is an LDL     lowering agent that works through inhibition of the fat absorption from the small intestine.     In this study, we propose to treat 50 patients with NASH with either Ezetimibe or placebo for     24 weeks. After an initial evaluation for insulin sensitivity, MRI liver fat distribution and     liver biopsy, patients will receive either 10 mg/day of Ezetimibe or placebo. Patients will     be monitored at regular intervals for symptoms of liver disease, side effects of Ezetimibe     and serum biochemical and metabolic indices. At the end of 24-weeks, patients will have a     repeat medical evaluation, liver MRI and liver biopsy. Pre and post treatment MRI-derived     liver fat content, liver histology and insulin sensitivity will be compared. The primary end     point of successful therapy will be improvement in hepatic steatosis measured by MRI.     Secondary end points will be improvement in insulin sensitivity, liver histology and liver     biochemistry.   "
116063|NCT01766700|"     The no calorie drink study is looking for over 300 people to participate. The study is     evaluating the effect of no calorie beverages on weight loss and weight maintained over time     in people who drink diet beverages every day as compared to water only drinkers during the 1     year study period.   "
116064|NCT01766687|"     The investigators have designed a randomized controlled trial to test whether increased water     intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants     randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water     per day (depending on sex and weight), in addition to usual fluid intake, for one year. The     investigators will calculate the change in kidney function (estimated glomerular filtration     rate, measured every three months for 12 months), and compare renal decline between the     intervention and control groups. The investigators hypothesize that increased water intake     will slow renal decline.   "
116065|NCT01766674|"     This is a randomized, controlled trial among 100 total males and females with hyperkyphosis,     aged 60 years and older, to determine the effects of an exercise intervention that includes     high intensity spinal muscle strengthening exercises compared to a usual care waitlist group.   "
116066|NCT01766661|"     The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure     in comparison to the standard surgery for low rectal cancer. The investigators compare     quality of life, faecal incontinence and recurrence of neoplasm in patients who received     standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait     colo-anal anastomosis after Low Anterior Resection for rectal cancer.   "
116067|NCT01766648|"     To determine if Far Cortical Locking screws increase fracture healing rates at 3 months in     Closed Distal Femur Fractures in adults when compared to standard locking screw constructs.      Fracture healing at 3 months will be assessed via x-ray and clinical assessment of the     fracture.      Null Hypothesis: There will be no difference in fracture healing at 3 months post-fixation     between subjects treated with far cortical locking screw or standard locking screw fixation.   "
116068|NCT01766622|"     Background:      - 18F-CP18 is a chemical designed for use in imaging studies. It is attracted to tumor cells     that are being killed by cancer treatment. Researchers want to test it in imaging studies for     people who are being treated with Birinapant. Birinapant is a drug used to treat advanced     ovarian, fallopian tube, or peritoneal cancers. It works kills tumor cells that have not     responded to earlier treatment. 18F-CP18 may help to monitor cancer treatments with this     drug.      Objectives:      - To test the effectiveness of 18F-CP18 imaging studies during cancer treatment with     Birinapant.      Eligibility:      - Individuals at least 18 years of age who are taking Birinapant for ovarian, fallopian tube,     or peritoneal cancer.      Design:        -  Participants will have a brief physical exam. They will also answer questions about          their medical history and any current medications.        -  Participants will receive a dose of 18F-CP18, followed by an imaging study. The study          will involve a positron emission tomography/computed tomography (PET/CT) scan. The scan          will last 40 minutes.        -  There will be two more PET/CT scans 1 hour and 2 hours after taking 18F-CP18. These          scans will look at how the tumor cells absorb and process 18F-CP18.        -  This is a scanning study only. No treatment will be provided as part of this study.   "
116069|NCT01766609|"     Vitiligo is a chronic acquired disease characterized by well defined white macules and     patches affecting the skin. It has a major psychosocial impact on affected patients. There     are many treatment modalities available for vitiligo, however, none of them cure the disease.     Topical corticosteroids (CS) are the most effective monotherapy for localized vitiligo.     Treatment with intralesional corticosteroids (ILCS) is commonly used in many dermatologic     conditions. However, there are only a few studies published on the use of ILCS in vitiligo.     This is a prospective double-blind randomized clinical trial to assess efficacy and safety of     ILCS in the treatment of vitiligo. Four treatment sessions will be done over 4 to 6 months.     The investigators will compare intralesional triamcinolone acetonide (active treatment) to     normal saline (placebo).   "
116070|NCT01766596|"     The aim of the study proposed in Dijon is above all to focus on the possible relationship     between age-related ocular pathologies (AMD and glaucoma) and et les degenerative     neurological and cardiac pathologies.      The principal objective is to seek in subjects who have undergone cerebral MRI and     echocardiography, associations between the thickness of postganglionic fibers measured by     Optical Coherence Tomography at the 7th year (n=1500) and signs of cerebral impairment     (psycho-cognitive tests, circulation time, MRI signs). This association will be studied after     taking into account the principal environmental (particularly dietary) and genetic risk     factors.   "
116071|NCT01766583|"     This is an open label, 3 + 3 dose escalation study, to determine the MTD, safety, efficacy     and PK profiles for subjects with relapsed/refractory B-cell malignancies when using CC-292     and lenalidomide combination therapy. Subjects will be followed for disease progression and     collection of second primary malignancy (SPM) events. This dose escalation will be followed     by an exploratory expansion phase in 3 cohorts of 12 patients each.   "
116075|NCT01766531|"     Prospective cohort, monocentric non-randomized and interventional clinical study in ICU     assessing the evolution of body composition using bioelectrical impedance analysis.   "
116079|NCT01766479|"     Background: Although subjects with first-degree relatives (FDR) with a history of colorectal     cancer (CRC) are at increased risk for CRC, compliance to screening colonoscopy is     suboptimal. Computed tomographic colonography (CTC) has been recognized as an alternative for     CRC screening in average risk subjects, but less information is available on its performance     in FDRs.      Aims: To prospectively assess the accuracy of CTC as a screening tool in FDRs using     colonoscopy (OC) with segmental unblinding as reference standard.      Methods: Consecutive patients admitted with CRC diagnosis (index case, IC) were prospectively     evaluated. Following the systematic identification of ICs with inherited predispositions to     CRC, ICs who agreed to contact their FDRs ≥40 years old were included. Available FDRs were     invited to undergo non-cathartic CTC, with OC the following day.     Sensitivity/specificity/PPV/NPV of CTC was assessed for detecting subjects with any lesion ≥6     mm, ≥10 mm, and for advanced neoplasia ≥6 mm.   "
116080|NCT01766466|"     To demonstrate that patients treated with cangrelor can be directly switched to oral     ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a     significant decrease in the extent of inhibition of platelet aggregation.   "
116081|NCT01766453|"     South Asians have one of the highest rates of heart disease of all populations and a unique     and deleterious obesity phenotype of increased body fat and inner-abdominal compared to those     of European background. We have subsequently identified that this unique phenotype accounts     for much of the increased heart disease risk in South Asians, with the greater amounts of     inner abdominal fat being particularly implicated. In addition, South Asians in Canada have     substantially lower levels of leisure-time physical activity.      At present, we do not know the answers to the following questions:        1. Is a conventional (standard) physical activity program that has proven effective at          reducing inner abdominal fat and heart disease risk factors in populations of European          background be effective in South Asians?        2. Is an alternative physical activity program commonly practiced by South Asians (such as          bhangra dance) be effective at reducing inner abdominal fat and heart disease risk          factors in South Asians? In this study, we will perform a randomized controlled trial of          three conditions—gym-based standard exercise program (SE),bhangra dance exercise program          (BE) and non-exercise control (NE).We will recruit 75 post-menopausal South Asian women          with abdominal obesity and assign them randomly to one of the three groups (25 per          group).      We anticipate that both the SE and BE programs will be superior to the NE group in terms of     reducing VAT and CVD risk factors. Such findings will demonstrate that exercise is an     effective method that favourably modifies the obesity phenotype of excess VAT in South     Asians, and should be central to health promotion and disease prevention strategies.   "
116082|NCT01766440|"     The purpose of this study is to determine if the calcitriol absorption in pediatric subjects     is comparable to that in adults and adolescents, with no significant impact on     calcium/phosphorus metabolism.   "
116083|NCT01766427|"     1. To observe the Efficiency of Electroacupuncture for Hypertension Patients With Chronic          Kidney Disease.        2. To observe if different-time treatment having an impact on Hypertension Patients With          Chronic Kidney Disease.   "
116089|NCT01766349|"     The purposes of this study are to investigate in patients with newly diagnosed esophageal     cancer: 1)changes in pulmonary and respiratory muscle function, functional capacity and     quality of life during and after RT or CCRT treatment; 2)the correlations between these     changes; and 3)the impacts of these changes on the postoperative pulmonary complications     following esophagectomy.   "
116090|NCT01766336|"     To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in     Moderate to Severe AD patients with agitation and aggression.   "
116091|NCT01766323|"     Oral morphine is often utilized as a convenient and effective method of achieving palliation     of pain in the terminally ill cancer patients. However, at effective doses, a majority of     patients do experience an undue amount of excessive sleepiness. Given the generally low     expected survival periods among this patient population, the fact that morphine causes the     patient to spend a significant period of remaining life in sleep, is often unacceptable for     the patients and their families. Given the proven benefits of modafinil in conditions     characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the     investigators designed a prospective placebo controlled randomized trial by the addition of     modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after     randomization.   "
116093|NCT01766297|"     The purpose of this research study is to compare the effects (good and bad) on women and     their cancer using proton radiation therapy.      This study is being done to see if proton radiation therapy will prove to be beneficial for     women with early stage breast cancer. A clinical study is necessary to compare the results     (good or bad) of proton radiation therapy.   "
116094|NCT01766284|"     Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light     scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the uterine     cervix can differentiate between grades of pre-invasive and invasive cervical disease and     cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT) system to     detect pre-invasive cervical disease and cervical cancer.   "
116095|NCT01766271|"     The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the     feasibility and logistics of incorporating genetic risk information (9p21)into standard     Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in     primary care at 2 Duke Clinics.   "
116096|NCT01766258|"     The primary objective of the study is to assess the efficacy, carbidopa dose response and     safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment     of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.   "
116097|NCT01766245|"     This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence     (assessment of the expected biological equivalence of two pharmaceutical drug products with     identical active ingredient) between subcutaneous injections of semaglutide produced by two     manufacturing processes.   "
116098|NCT01766232|"     Epiphora, or uncontrolled tearing of the eyes, represents a common presenting complaint of     patients seen by ophthalmologists. Epiphora may be due to non-obstructive causes, such as     tear hypersecretion or functional tear pump failure, or obstructive causes. Functional tear     pump failure may result from malposition of the eyelids, such as an abnormal out-turning     (ectropion) or in-turning (entropion) of the eyelid.      Currently methods to diagnose partial nasolacrimal duct obstruction are purely qualitative in     nature. Our research goal is to quantitatively measure the pressure generated during     conventional probing and irrigation (P&I), and to measure the resistance to irrigation of the     nasolacrimal drainage system.      The investigators will measure the pressure generated during conventional P&I using a     disposable in-line pressure transducer. In addition, the investigators will use a syringe     pump to deliver a constant flow rate of saline through a nasolacrimal cannula and measure the     steady state irrigation pressure using the in-line transducer and digital pressure monitor.     Resistance can be directly calculated from the known flow rate and pressure measurements.      The investigators will compare both the pressure generated during P&I and the lacrimal     drainage resistance between patients with lacrimal drainage obstruction and controls patients     with no obstruction (functional tear pump failure) as determined by clinical exam.      Clinical applications for measuring lacrimal drainage resistance include quantifying partial     nasolacrimal duct obstruction, guiding the choice of surgical procedure, and determining the     success of lacrimal drainage procedures.   "
116099|NCT01766219|"     This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with     advanced or metastatic cholangiocarcinoma that cannot be removed by surgery.     6,8-Bis(benzylthio)octanoic acid may stop the growth of cholangiocarcinoma by blocking blood     flow to the tumor   "
116100|NCT01766206|"     A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure     requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety     evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving     MenACWY-CRM vaccination according to routine clinical practice and prescribing information.   "
116101|NCT01766193|"     The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary     incontinence is high. Previous studies have shown that pregnancy and childbirth are risk     factors for developing prolapse. There is a lack of studies that follow women several years     after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie     vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this     study is to get more knowledge about pathology of prolapse and incontinence, to enable     development of preventive strategies for these conditions.      Aim of the study is to determine whether the prevalence of symptoms and performed surgery for     urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery     and cesarean section 15-20 years after their first delivery.      The investigators identify women that delivered their first child at St. Olavs Hospital,     Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7,     PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor     musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of     prolapse performed.   "
116111|NCT01766063|"     The study aims to investigate the relationship between sleep quality, quality of life,other     disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.   "
116112|NCT01766050|"     The purpose of this study is to determine the effects of belatacept on the pharmacokinetics     of caffeine, losartan, omeprazole, dextromethorphan and midazolam   "
116102|NCT01766180|"     The purpose of this study is to determine whether Fruitflow-II, Resveratrol (resVida), alone     or in combination, are effective in the treatment of memory problems in adult patients with     memory impairment. We also evaluate effects of these medications on blood flow to the brain     and fitness, to find whether the possible improvement in memory is associated with the     alterations in these parameters.   "
116103|NCT01766167|"     To conduct the following evaluations in Korean healthy male adult volunteers receiving a     single and multiple doses of MP-424 tablets:        -  Pharmacokinetics of MP-424 after a single and multiple doses.        -  Safety and tolerability of single and multiple doses of MP-424.   "
116104|NCT01766154|"     The purpose of this study is to evaluate tirofiban concentration in the blood over a period     of 24 hours after tirofiban administration. Subjects with varying degrees of renal     insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be     cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to a     slower extent compared to people without kidney problems. By comparing the tirofiban     concentration profile between subjects with healthy kidney function versus with impaired     kidney function, a tirofiban dosing recommendation for subjects with impaired kidney function     can be made.      This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25     µg/kg administered intravenously over a 3 min period) will be administered to subjects with     normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (<30 mL/min     CrCl) renal impairment with non-dialysis-dependent renal insufficiency   "
116105|NCT01766141|"     It is expected that mechanical low back pain (LBP) is associated with inflammatory changes     localized to the affected tissues. Could such changes be detected in cells involved in the     inflammatory process in an in vitro model? The investigators wish to test such a model to     compare inflammatory markers in acute and chronic LBP patients and also examine the effect of     spinal manipulative treatment (SMT) on changing the level of selected key inflammatory     markers. The investigators hypothesize that:        1. Proinflammatory markers will be elevated while antinflammatory markers will be reduced          in acute LBP patients relative to chronic back pain patients as well as in healthy study          participants who have no LBP or any inflammatory conditions (controls).        2. SMT will cause a reduction in the production of proinflammatory markers while          anti-inflammatory markers will increase relative to baseline levels as well as relative          to controls   "
116106|NCT01766128|"     The aim of this study is investigation of neuroprotective effect of zonisamide in early     Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study     criteria will be enrolled and randomized into two groups alternately based on their visit     date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn&Yahr     and modified Schwab&England activities of daily living scale will be determined and     registered for each patient. Patients of group A will be treated by zonisamide 50mg/d for 12     months and the other group will be treated by placebo for the same time. Primary endpoint is     occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause     psychosocial embarrassment. The mentioned scores will be registered every 2 months for both     groups by blinded neurologist and also regular blood test will be performed to prevent drug     adverse events.   "
116107|NCT01766115|"     To assess the safety and tolerability of the use of telaprevir in the setting of     post-exposure prophylaxis among HCW exposed to HCV genotype 1 or genotype 2.      To assess the election rate of postexposure prophylaxis for HCV-related occupational     exposures in HCW.   "
116108|NCT01766102|"     A breast biopsy in the operating room may be needed in up to 15% of patients with an     abnormality on mammogram. When an abnormality is present but there is no palpable mass, the     abnormality must be localized with a wire before going to the operating room. This technique     is also used when a breast cancer is present but there is no mass, in order to perform a     targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire     is taken to the breast imaging department for a specimen x-ray to ensure that the targeted     abnormality is present within the specimen. If the abnormality is close to the edge of the     specimen, additional tissue is often removed.      A newer method for evaluating the specimen is to perform imaging in the operating room.     Portable digital mammography units are available for this purpose. The Biovision digital     specimen mammography system is FDA-approved and currently in use in over 200 centers in the     United States. Several studies have shown that intra-operative digital mammography is as     accurate as standard specimen mammography and takes less time to perform. It may also     decrease the chance of having to go back to the operating room to take more breast tissue     after lumpectomy because of cancer cells near teh margin(s) of the specimen on final     pathology. Having to go back to the operating room to take more tissue is called a     re-excision.      The purpose of this study is to compare standard specimen mammography to intra-operative     specimen mammography to quantify potential operating room time savings and to determine if     the use of intra-operative specimen mammography decreases re-excision rates. We aim to see if     intra-operative specimen mammography is more efficient and if it decreases re-excision rates.   "
116109|NCT01766089|"     Preeclampsia is a pregnancy-specific, multisystem disorder that complicates approximately 5 %     of pregnancies.      Tracheal intubation in the women with severe pre-eclampsia is usually associated with     exaggerated transient increases in blood pressure, heart rate and maternal plasma     catecholamine concentrations. These changes may lead to maternal cerebral oedema,     haemorrhage, left ventricular failure, pulmonary oedema or mortality, and reduce uterine     blood flow which may adversely affect the neonatal wellbeing. Therefore, the attenuation of     the haemodynamic responses to tracheal intubation in this unique group of patients is     demanding for the best of both mother and foetus.      The use of single remifentanil boluses of 0.5 to 1 µg/kg reduces effectively the haemodynamic     and catecholamine responses to laryngoscopy and tracheal intubation in severe pre-eclamptics     during Cesarean delivery under general anesthesia. Unfortunately, the use of 1 µg/kg doses     are associated with more maternal hypotension and neonatal respiratory depression requiring     resuscitation. Moreover, the use of preinduction remifentanil bolus of 0.5 µg/kg followed by     a continuous infusion at 0.15-0.2 µg/kg/min is associated with significant attenuation of the     maternal stress response to tracheal intubation with variable degree of neonatal depression     in non-pre-eclamptic women. Whereas, the use of infusion rates of 0.1 µg/kg/min or less is     less likely to produce neonatal depression.      In our previous study, we demonstrated that the preoperative administration of     dexmedetomidine 0.4 and 0.6 µg/kg/h, a specific alpha 2-adrenoceptor agonist, blunts the     maternal haemodynamic and hormonal responses to Caesarean delivery under sevoflurane     anaesthesia without adverse neonatal effects. However the use of 0.6 µg/kg/h doses is     associated with higher postoperative sedation scores.   "
116110|NCT01766076|"     We hypothesise that atorvastatin changes immune activation among HAART-treated adults with     suboptimal cluster cell differentiation 4 (CD4) recovery by 25%   "
116114|NCT01766024|"     This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and     tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif®     (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to     demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability     parameters after single subcutaneous injection. Each dtug will be administered to each     volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least     14 days.   "
116115|NCT01766011|"     The purpose of this study is to assess overall growth of preterm infants fed a reformulated     preterm infant formula during hospitalization. All study products meet levels of nutrients     for the infant population as specified in the Infant Formula Act and all subsequent     amendments.   "
116116|NCT01765998|"     Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It     includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be     effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing     enterocolitis,helicobacter pylori infections, etc.   "
116117|NCT01765985|"     Interferential current has shown promising results for treating psoriasis with a good     tolerance. Prospective randomized studies versus placebo are required to confirm the interest     of such an approach.      The Main objective is to assess the efficacy of interferential current for treating     palmoplantar psoriasis.      Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on     the nails, to study the potential side effects.   "
116118|NCT01765972|"     The primary purpose of this clinical trial is to evaluate the eye's response to three test     soft contact lenses as well as no lens wear, with respect to Corneal Staining.   "
116119|NCT01765959|"     Auricular acupuncture and cognitive behavioral therapy in the context of insomnia and low     dose dependence of benzodiazepine-like drugs and other sleep medicine with addiction risk      INTRODUCTION: Insomnia is a common health problem in Sweden, which increases with age and is     more prevalent among women.      It is defined by unsatisfied sleep quality during more than a month's time. The main symptoms     are difficulties falling- and/or maintaining sleep, involuntary awakenings during the night     of early morning, day time sleepiness and decreased will for day time activity due to     sleepiness. Insomnia is ranked to be the fifth most common cause of prescription of medicine     at the outpatient clinics in general health care in Sweden. In 2008 a prevalence study was     initiated in Sweden by the Swedish Council on Health Technology Assessment (SBU). The study     showed that 24% of the Swedish population suffered from sleep disorders. Sleeping disorders     can go on for many years and can therefore entail significant personal suffering.      Usually sleep medicine combined with general sleeping advices is the first-hand treatment for     insomnia. However, according to SBU, first treatment should be non-pharmacological, for     instance cognitive behavioral therapy (CBT). Despite this recommendation the prescribing of     sleep medicine is still high.      There are studies that suggest auricular acupuncture (AA) to be an effective method to treat     insomnia. However more evidence is needed to draw firm conclusions.      AIM: The aim of the study is to investigate if AA is as effective as CBT to treat insomnia     for patients who have stopped using benzodiazepine-like sleep medicine.      METHOD: This is a randomized controlled study (RTC) including patients suffering from     insomnia, with a low dose dependence of benzodiazepine-like drugs. The patients will be     recruited from primary care and from an out-patient clinic specialized in sleeping disorders     and also by add in the local news paper. The respondents will be randomized to one of two     groups; group I will receive AA twice a week for 4 weeks; group II will receive CBT once a     week for six weeks. After three months there will be a long-time follow up in order to     investigate a potential long-term effect.   "
116120|NCT01765946|"     Pre-diabetes, a condition characterized by hyperglycaemia, is associated with increased     cardiovascular risk and reduced life expectancy, as compared to the general population.     AMP-activated protein kinase (AMPK) is an enzyme that plays a key role in cellular energy     homeostasis and metabolism, and recently it has been demonstrated that AMPK regulates aging     pathways, as well. AMPK is susceptible to modulation through pharmacologic (e.g. metformin)     and non-pharmacologic (e.g. physical exercise) interventions. This clinical trial aims to     describe the effects of the AMPK pathway on longevity genes and inflammation in the setting     of pre-diabetes in vivo and in vitro. To this end, the investigators will compare treatment     with metformin (500 mg t.i.d) for 2 months, versus placebo in pre-diabetic subjects. The     investigators will assess expression of longevity genes SIRT1, p66Shc, p53 and mTOR in     peripheral blood mononuclear cells (PBMCs) ex vivo. The investigators will evaluate monocyte     polarization by flow cytometry, according to the expression of surface antigens (CD68, CCR2,     CD163, CD206, CX3CR1) to determine the prevalence of pro- or anti-inflammatory cells.     Inflammatory cytokines (TNF-alpha, MCP-1, IL-1, IL-6, IL-10, CCL12) will also be determined.     In the in vitro study the investigators will evaluate the effects of AMPK activation or     inhibition on longevity gene and protein expression.   "
116121|NCT01765933|"     1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary     supplements. It is also used within party pills, often in conjunction with alcohol and     other drugs, and has been associated with untoward effects when abused at high dosages. To     our knowledge, no studies have been conducted to determine the combined pharmacokinetic     profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based     solely on case reports would be problematic, in particular when accepting testimony from     patients in uncontrolled environment, potentially under the influence of alcohol and other     drugs. This is especially true in light of the fact that no prospective studies have shown     these effects. Hence, the intent of the present study was to determine the pharmacokinetic     profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This     represents a typical dosage within one serving of many popular dietary supplements containing     DMAA.   "
116122|NCT01765920|"     The purpose of this study is:        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper          respiratory tract infections in adult patients.        -  to assess clinical efficiency of the liquid dosage form of Ergoferon for treatment of          acute upper respiratory tract infections in adult patients.   "
116123|NCT01765907|"     Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound     (HIFU).   "
116150|NCT01765803|"     This study will investigate the possibility of using the drug thioridazine (also called     Mellaril) to increase the number of certain types of cells moving from the bone marrow to the     circulation in a group of healthy humans. The types of cells we hope to collect are called     CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better     understand a number of diseases and suggest new strategies for therapy. Perhaps the most     important potential application of human stem cells is the generation of cells and tissues     that could be used for cell-based therapies, as a renewable source of replacement cells and     tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns,     heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.   "
116124|NCT01765894|"     Project description      Research project title:      Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls.      Project description and objective      Obesity is so widespread in Denmark that 47% of the population is classed as overweight     (BMI>=25) and around 13% of the population is classed as obese (BMI>=30).      The strong correlation between obesity and type 2 diabetes (at least 2/3 of type 2 diabetics     are overweight) has led to many studies which look at different forms of exercise for this     group, because weight loss may improve the diabetes and even defer the onset of the disorder     and in doing so lower complications and increase long term survival.      For people who do not have type 2 diabetes, the work-induced increased sympathetic activity     will lead to suppressed insulin secretion and increased glucagon secretion. This increases     the endogenous glucose production from the liver and thus maintains a normal concentration of     blood sugar in a physical training situation where the demand for glucose has increased.      The theory behind the project is that the mechanisms that help to increase glucose production     in the liver during physical activity are weaker in type 2 diabetics, which can cause     hypoglycaemia during and after physical exercise. In other words, we want to study the     liver's sensitivity to stimulus from physical work by patients with type 2 diabetes and in     relevant healthy control subjects.      Previous studies have indicated that this type of mechanism is not intact in type 2     diabetics; because the level of insulin does not fall as expected during or after physical     training. However, there are no existing studies that measure the liver's glucose secretion     using stable isotopes during prolonged moderate physical work. Measuring this will help to     clarify our understanding of glucose homeostasis in type 2 diabetics.      This study is very relevant, because it may be expected that the preferred form of physical     exercise of an overweight type 2 diabetic can be of moderate intensity and previous studies     also show that this form of physical exercise delivers health gains in terms of an     improvement in insulin sensitivity and a reduction in the level of insulin.      The objective of this study is to determine if the level of blood glucose stays constant     before, during and after physical training and to examine the liver's ability to secret     glucose accordingly.   "
116149|NCT01765816|"     Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The     extent of reduction will be intensity dependent.      As part of the Generation 100 study, this sub-study project will investigate the effect of     exercise on blood volume, cardiopulmonary health and heart function in healthy aging.     Objective is to determine the acute effect of one endurance training session on blood volume     in healthy elderly. The working hypothesis is that one interval training session increases     total blood volume by 10% in healthy elderly, and that there will be no change after moderate     continuous training.   "
116125|NCT01765881|"     For about 10% of pregnancies, it is necessary to induce delivery for medical reasons.     Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In     France, dinoprostone is the own approved medication. It is in the form of gel or sustained     release device whose effectiveness and side effects are comparable. The vaginal misoprostol     has no marketing authorization in France, but is sometimes used. Some data in the scientific     literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more     complications, was at least as effective and seems to be cost-effective compared with     dinoprostone. Misoprostol with this dose and route of administration is now recommended by     the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice     Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on     induction of labor). According to HAS, the investigators still lack data on large samples to     confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of     cesarean section, and lower cost compared to dinoprostone.      The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs.     dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5%     difference.   "
116126|NCT01764906|"     The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral     fusion   "
116127|NCT01764893|"     The null hypothesis for this study is that the combination of solifenacin and Percutaneous     Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators     anticipate a 20% improvement in patients receiving combination therapy as measured by the     OAB-q (Overactive Bladder questionnaire) scores.   "
116128|NCT01764880|"     Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and     participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating,     among other activities, cell invasion associated with cancer metastasis, angiogenesis, and     inflammation. The heparanase enzyme is a promising target for development of new anticancer     drugs. HS and the structurally related heparin are present in most animal species. As an     analogue of the natural substrate of heparanase HS, heparin is considered to be a potent     inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced     oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity     and are strictly related to the anti-heparanase activity. In preclinical murine models     SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models,     with a significant reduction of subcutaneous growth of different multiple myeloma cell lines,     when SST0001 was administered either alone or in combination with dexamethasone. The purpose     of this study is to determine the safety and tolerability of escalating doses of SST0001 in     the treatment of advanced refractory multiple myeloma.   "
116129|NCT01764867|"     The purpose of this study is to compare treatment outcomes between measurement based     Algorithm Guided Treatment and Treatment As Usual strategies in a Chinese population with     major depressive disorder.   "
116130|NCT01764854|"     The purpose of this study is to determine if the study drug is safe, tolerable and active in     reducing fluid overload/weight gain between dialysis sessions for patients with End Stage     Renal Disease on Hemodialysis.   "
116131|NCT01764841|"     The purpose of this study is to evaluate if the time to first pulmonary exacerbation of     bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days     every other 28 days or for 14 days every other 14 days over 48 weeks.   "
116132|NCT01764828|"     This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety,     tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in     combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood     samples for PK (pharmacokinetics) analyses will be collected after a single dose of     BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and     BAY86-9766.      Safety evaluation will include adverse events assessment, vital signs, laboratory tests,     12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination     at various time points during the study.   "
116133|NCT01764815|"     The purpose of this study is to provide proof-of-concept that directional stimulation, in an     intraoperative setting, is perceivable in a subject and is different from omnidirectional     stimulation. The tests will be performed using a dedicated DBS lead connected to external     neurostimulator.   "
116134|NCT01764802|"     This randomized phase II trial studies how well psychosexual intervention works in patients     with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual     and psychosocial function.   "
116138|NCT01764750|"     Surgical wound infections remain a serious problem despite aseptic techniques and the use of     prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in high-risk     patients receiving long segment instrumented spinal fusions for deformity correction and     present potentially catastrophic consequences. Given this, the high cost of treatment, and a     payer system unable to support such expenses, investigators must make every effort to find     new cost-effective ways to prevent these complications.      Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin     into spinal surgery wounds immediately prior to wound closure. This method, known as     intrasite application, is adapted from techniques used to prevent infection in joint     replacement surgeries. The motivation for this practice is to maximize antibiotic     concentration within the wound while minimizing systemic concentration and toxicity, (the     inverse of the situation when using IV antibiotics). While the popularity of intrasite     delivery has grown rapidly, this has occurred without prospective scientific evidence.     Recently, three retrospective papers including nearly 2,500 treated patients, indicated that     intrasite Vancomycin reduces wound infections without increasing adverse events[1-3].     However, there are no published data on the dosing or pharmacokinetics of intrasite     Vancomycin, let alone prospective trials of its efficacy and safety.      The investigators propose to perform the first prospective trial of intrasite Vancomycin     pharmacokinetics and safety. Study objectives will include standardizing application and     dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal     potency, and dose selection for use in future studies. This will be accomplished by enrolling     groups of patients (n=10) to receive one of three doses of intrasite lyophilized Vancomycin     (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous blood and     wound seroma fluid will be measured at regular intervals after surgery to establish     pharmacokinetic parameters. Preliminary data regarding local and systemic adverse events     including wound healing, fusion rate, and toxicity will be prospectively collected. The     ultimate goal of this learning-phase study is to gather sufficient information regarding     application, dosing, pharmacokinetics, measurement strategies, and adverse events to prepare     for a Phase III efficacy trial.   "
116139|NCT01764737|"     The purpose of this study is to evaluate the safety and tolerability of IV administration of     VX15/2503 in patients with multiple sclerosis. The escalation part of the study will     determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is     found.   "
116140|NCT01764724|"     Sodium-related claims on food labels should help people find lower sodium food choices;     however consumer attitudes and understanding of such claims are unknown.      The objective of this study was to evaluate: 1) the attitudes and understanding to different     types of permitted sodium claims and 2) the effect of hypertension on responses to such     claims.   "
116141|NCT01764711|"     This study is to determine different chemical levels in the blood during a low salt diet.     This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS)   "
116142|NCT01764698|"     Anxiety disorders are highly prevalent among those with substance use disorders, but the     majority of addictions treatment centers provide little to no evidence-based treatment for     anxiety disorders. Furthermore, tension reduction models suggest that treating anxiety should     also improve substance use outcomes. This study is aimed at improving symptoms for people who     have substance use and anxiety problems. The study is comparing regular Intensive Outpatient     treatment for addiction to Intensive Outpatient treatment for addiction plus treatment for     anxiety disorders. Clinicians at a community addictions clinic will participate by receiving     training in delivering cognitive behavioral therapy for anxiety disorders and will deliver     the treatment to the patient participants. They will also complete some questionnaires.     Patient participants will be asked to complete a baseline assessment. Those who are eligible     will be randomly assigned to one of the two treatment groups. Those who are assigned to     addiction treatment as usual will continue their regular care at the Matrix Institute.     Participants who are assigned to also receive the anxiety treatment will be asked to     participate in 6, 90-min treatment sessions and an orientation session. All participants will     be asked to complete post-treatment and follow-up assessments. The assessments should take     approximately 1 hour, and the follow-up assessment will be completed 6 months after treatment     is over. It is hypothesized that those who get the additional anxiety disorder treatment will     show greater improvement in anxiety and substance use outcomes than those who get Intensive     Outpatient Program without the anxiety disorder treatment.   "
116143|NCT01764685|"     Heavy drinking (HD) is a risk factor for HIV transmission and is more common in HIV+     individuals than in the general population. HD adversely affects health directly and reduces     adherence to antiretroviral therapies (ARTs), in part due to alcohol-induced cognitive     impairment. Reduced drinking improves cognitive performance and adherence to ARTs.     Medications approved in the United States to treat alcohol dependence have a small effect     size. However, topiramate, FDA-approved as an anticonvulsant and a prophylaxis for migraine,     has a greater effect size in reducing drinking and promoting abstinence in alcohol dependent     individuals. To date, there are no studies of the effects of topiramate in HIV+ heavy     drinkers. The investigators propose to conduct a randomized, parallel-groups,     placebo-controlled, 11-week trial of topiramate in 40 HIV+ heavy drinkers who want to reduce     or stop their drinking. There are three primary hypotheses for this feasibility and     proof-of-concept study. First, the investigators hypothesize that topiramate-treated patients     will decrease the frequency of their HD more than placebo-treated patients. Second, based on     scores from computerized neurocognitive assessments, the investigators hypothesize that     topiramate and placebo groups will show similar performance on a battery of cognitive tests.     Third, based on self-reported medication adherence, the investigators hypothesize that     adherence to ARTs will be greater in the topiramate group than in the placebo group. These     findings will provide preliminary data to support a more definitive trial of topiramate for     the treatment of HD in HIV+ heavy drinkers.   "
116144|NCT01764672|"     The goal of the study is to use graph theory to examine how the organization of the     functional brain network may be altered by the administration of methylphenidate. This effect     is to be compared between methylphenidate intake and placebo intake, as well as between     healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity     Disorder.   "
116145|NCT01765868|"     This is a open label, single center, single oral dose, study of PRT054021, in healthy     subjects.   "
116146|NCT01765855|"     This is a open label, single center, single oral dose, study of PRT054021, in healthy     subjects.   "
116147|NCT01765842|"     Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus     Nephropathy Resistant to Conventional Treatments   "
116148|NCT01765829|"     The purpose of this study is to assess if patients who continue with antipsychotic treatment     for 12 or more months show the same risk of relapse (measured by PANSS) that patients with     the same medical condition who have followed a discontinuation treatment scheme based in the     presence of prodromes.      The candidates should accomplish the following criteria: first episode of non-affective     psychosis who have followed antipsychotic treatment for 12 months and who have already shown     remission criteria.   "
116152|NCT01765777|"     The purpose of the research study entitled Efficacy of Osteopathic Manipulative Medicine     (OMM) and Phototherapy for Patients with Chronic Lower Back Pain is to investigate the     hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and     phototherapy will provide greater pain relief for patients with chronic lower back pain, as     compared with standard medical management or either treatment alone.   "
116153|NCT01765764|"     This study will evaluate the safety and efficacy of bimatoprost solution compared with     vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).   "
116154|NCT01765751|"     The purpose of the Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain     Clinical Trial is to examine the patient‐centered clinical and biomechanical outcomes, doctor     treatment delivery, and believability characteristics of a commonly used chiropractic     procedure for the treatment of neck- or neck-related arm pain or disability.   "
116155|NCT01765738|"     To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a     conventional PICC catheter in a tertiary care patient population. Secondary goals will be to     determine if there is a difference between the two catheters with early and late infections,     to determine the cost comparison including extra cost of treatment for a line related     infection, to determine if there are any non-infectious related complication differences     between the two catheters.   "
116156|NCT01765725|"     The aim of the study is to develop, carry out, evaluate and measure the effects of a new     patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary     healthcare.      In an randomized controlled trial design the effects of the patient education program on     coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of     life, self- efficacy, and illness perception will be compared with treatment as usual.      The results of the main project will lead to the elaboration of the final patient education     program that can be implemented in primary health care, as well as development of a training     program for future program-conductors.   "
116157|NCT01765712|"     The purpose of this research study is to investigate whether or not platelet rich plasma     (PRP) may help to improve tendon healing and decrease post operative pain in patients     undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar     tendons as autografts.   "
116158|NCT01765699|"     Aim To identify through data analysis key patients, surgeon and operative dependent variables     which will improve the performance of knee replacement for primary osteoarthritis      Research Question        1. Can the investigators identify association between outcomes and patients characteristics          using existing (already collected) datasets        2. What are the characteristics of patients with poor outcome after knee replacement        3. What can be done to improve the outcome of patients at risk of poor results   "
116159|NCT01765686|"     Energy devices are used routinely during thyroid surgery to aid surgical dissection and to     stop bleeding. The newer generation energy devices have several advantages over older     machines. The two most commonly used newer generation energy devices are the Harmonic scalpel     and the Small Jaw bipolar device. Currently there has been no randomized controlled trial     that compares both devices side to side. We aim to compare the effectiveness of these two     newer generation energy devices in thyroid surgery.   "
116160|NCT01765673|"     The purpose of this study is to develop a vibratory self-trainer for the treatment of     dysphagia post-stroke.      The aim is to identify the optimal stimulation characteristics for use with participants with     swallowing problems including:        -  Frequency of vibration        -  Mode of vibration either continuous or pulsed        -  Pressure of device against the neck        -  Duration of vibration to allow a participant to initiate a swallow   "
116161|NCT01765660|"     The purpose of this study is to evaluate the utility of treating patients experiencing     refractory chronic graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem     cells from third-party donors. The objective was to evaluate the effect and safety of such     treatment on refractory chronic graft-versus-host disease.   "
116162|NCT01765647|"     Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption     of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of     the small intestine to gluten causes an inflammatory response, leading to the destruction of     intestine lining, often with severe symptoms including diarrhea, abdominal distention,     fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the     only treatment currently available is strict adherence to a life-time gluten free diet (GFD).     However, adhering to this diet is difficult as gluten proteins are found in many food     products. Therefore, the gluten-free diet has both lifestyle and financial implications for     the individual and thus has been potential for impacting adversely on their quality of life.      Various approaches are being studied to reduce the need for careful control of the diet for     those with CD, including the use of antibodies such as IgY. IgY is produced from the egg     yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal     toxicity, for those without egg allergy, and offer low-cost, hygienic production of study     product. Once the IgY antibody is put into capsule form, it is called AGY.      Individuals with CD will be recruited only if they have a history of biopsy proven CD,     currently follow a GFD but continue to have mild to moderate symptoms related to gluten     exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at     screening. Those enrolled will have a 2 week run-in period where diet and symptoms are     recorded, and will then receive AGY capsules to take with meals over a 4 week period.     Outcomes will be measured by examining lab test results including antibody levels, symptoms,     and quality of life.   "
116163|NCT01765634|"     The purpose of this study is to evaluate the utility of treating patients experiencing     refractory acute graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem     cells from third-party donors. The objective was to evaluate the effect and safety of such     treatment on refractory acute graft-versus-host disease.   "
116164|NCT01765621|"     Leumit Health Services, an health maintenance organization operating in Israel, will     incorporate a web-based, decision support system for handling drug-drug interactions and drug     information, termed DDI+ reinforced with patient specific pharmacogenetic data. The     investigators hypothesize that implementing such a system will reduce health-care     expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).   "
116165|NCT01765608|"     This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with     moderate to severe obstructive sleep apnea. Patients will be randomized to receive     zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5     month open extension part will follow when patients in the tablet groups will all receive     zonisamide. Patients in the open CPAP group will continue with CPAP treatment.      Study hypothesis:      Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA     and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical     treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is     hypothesized that zonisamide has a direct pharmacological effect on respiratory control     during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction     of sleep disordered breathing.   "
116166|NCT01765595|"     Leumit Health Services, an health maintenance organization operating in Israel, will     incorporate a web-based, decision support system for handling drug-drug interactions and drug     information, termed DDI+. the investigators hypothesize that implementing such a system will     reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging     procedures).   "
116167|NCT01765582|"     This randomized, open-label, multicenter study will evaluate the efficacy and safety of     folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) /     bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin),     5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with     metastatic colorectal cancer. Participants will be randomized to receive bevacizumab 5     milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or     sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by     maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine     until disease progression occurs. After disease progression, participants will receive     treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.   "
116168|NCT01765569|"     This open-label, multi-center, three-period, one sequence study will investigate the effect     of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable     BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a     V600-activating mutation of BRAF without acceptable standard treatment options. Patients will     receive multiple doses of vemurafenib in Periods B and C and a single dose of digoxin in     Periods A and C. Eligible patients will have the option to continue treatment with     vemurafenib as part of an extension study (NCT01739764). The anticipated time on study     treatment is approximately 36 days.   "
116169|NCT01765556|"     This open-label, multi-center, three-period, one sequence study will investigate the effect     of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable     BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a     V600-activating mutation of BRAF without acceptable standard treatment options. Patients will     receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in     Periods B and C. Eligible patients will have the option to continue treatment with     vemurafenib as part of an extension study (NCT01739764). The anticipated time on study     treatment is approximately 19 days.   "
116170|NCT01765543|"     This open-label, multi-center, three-period, one-sequence study will investigate the effect     of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation     positive metastatic melanoma or other malignant tumor type that harbors a V600-activating     mutation of BRAF without acceptable standard treatment options. Eligible participants will     have the option to continue treatment with vemurafenib as part of an extension study GO28399     (NCT01739764).   "
116171|NCT01765530|"     The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear)     for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators hypothesize     that a protocol of routine ETT cleaning with endOclear may increase the ETT luminal volume     measured at extubation compared to the current standard of care. The device may therefore be     clinically useful by better maintaining the ETT original function.   "
116172|NCT01765517|"     Probiotics, which are believed to be health promoting live microorganisms, have been reported     to influence circulating endotoxin levels. Ingestion of the live cultures may alter gut     mircobiota in a beneficial manner to reduce inflammation; although their mechanism and     influence to reduce inflammation in T2DM is not established for this disease state.     Therefore, the aim of this study is to (1) characterize the beneficial effects of probiotics     on circulating endotoxin levels and other biomarkers related to systemic low-grade     inflammation in patients with T2DM; (2) Compare circulating endotoxin levels and inflammatory     cytokine levels between patients treated with probiotics or placebo to examine the beneficial     effects of probiotics on reducing the inflammatory status, through assessment of systemic     markers (adipokines, endotoxin, cytokines); (3) to examine the effects of probiotics on gut     microflora in order to understand the mechanism for such change in inflammatory status. To     achieve this, 120 consenting adult Saudis, naïve or newly diagnosed T2DM patients without     co-morbidities, will be enrolled in this clinical trial and randomized to receive twice-daily     placebo or probiotics for 26 weeks in a double-blind manner. Glycemic inflammatory markers     will be measured and fecal samples analysed, interventions will be done at baseline, 4, 8, 12     and 26 weeks. It is envisaged that probiotics will induce beneficial changes in gut     mircobiota, reduce the systemic inflammatory state through altering systemic endotoxin levels     and, as such, reduce the systemic inflammatory response observed in T2DM subjects. This will     have a fundamental impact on how we should treat the inflammatory component of T2DM,     particularly once the results are verified in a larger cohort of patients, as this could have     very dramatic effects on how we treat patients with T2DM. Reducing the pathogenesis of T2DM     by dampening the inflammatory response, which may also impact on insulin resistance status     and health of the individual, will have clear benefits. This could have profound effects on     preventative T2DM management, as well as current T2DM care without excessive cost for the     wider Saudi health economy.   "
116173|NCT01765504|"     Using the 9 centers (Appendix B) involved with the planned multicenter NIRS comparative     effectiveness trial the specific aims of this study are:        1. To demonstrate the feasibility of collecting rScO2 data from patients undergoing cardiac          surgery in a multicenter study design.        2. To demonstrate the feasibility of using a standard algorithm for treating rScO2          desaturations during cardiac surgery in a multicenter study design.   "
116174|NCT01765491|"     Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient     preparation and colonoscopy. The aim of the investigators study is to compare the efficacy     and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in     hospitalized patients undergoing colonoscopy.      This is a single-center, prospective, endoscopist-blinded study in which hospitalized     patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one     gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The     primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The     investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa     scale between arms. Secondary end points are patient compliance and tolerance.   "
116175|NCT01765478|"     HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a     member of the Tec family of non-receptor protein tyrosine kinases. BTK is mostly expressed in     hematopoietic cells such as B cells, mast cells and macrophages. BTK plays key roles in     multiple cell signaling pathways including B-Cell Receptor (BCR) and Fc receptor (FcR)     signaling cascades and is an essential mediator not only in B-cell dependent but also in     myeloid cell dependent inflammatory arthritis. HM71224 has been selected as a novel     therapeutic agent for the treatment of autoimmune diseases such as rheumatoid arthritis (RA).      In view of the above, further development of HM71224 for the treatment of RA is warranted. In     this first-in-man (FIM) study, a single and multiple dose escalation design will be employed,     in which the primary objective is to evaluate the safety and tolerability of the compound.     The biomarkers included as pharmacodynamic (PD) variables are chosen as they are indicators     for any effects of HM71224 on the expected mode of action (pBTK, pPLCγ, and pERK).   "
116176|NCT01765465|"     Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually     manifested by the presence of abdominal symptoms following gallbladder removal. The     pathogenesis of PCS has not been identified; therefore there is no consensus of medical     treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric     acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients     with cholesterol gallstones, and to promote biliary lipid secretion.      The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS     and symptoms change after laparoscopic cholecystectomy   "
116177|NCT01765452|"     The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of     Plavix with Astrix.   "
116178|NCT01765439|"     The aim of the study is to determine, whether administration of VSL#3 (Original De Simone     formulation) probiotic preparation can alter the bile acid metabolism in patients with     inflammatory bowel disease.   "
116179|NCT01765426|"     The purpose of this study is to compare the safety, tolerability and immunogenicity of     Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered     intradermally in varied dosing schedules and via different methods of administration     (conventional needle/syringe versus needle-free PharmaJet® injector).   "
116180|NCT01765413|"     It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific     adaptive immunity (the desired effect), but excessive inflammation may lead to serious     inflammatory complications or unwanted side effects. Currently there is a lack of reliable     biomarkers (a measurable biological response that predicts something) able to predict severe     inflammation and this has resulted in the development of several vaccines being terminated     and the withdrawal of some licensed vaccines which were associated with inflammatory     complications.      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the     Innovative Medicine Initiative. The project involves a series of clinical studies using     licensed vaccines as benchmarks to generate clinical data on inflammation and identify     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify     biomarkers that can predict the occurrence of beneficial and detrimental effects in response     to a vaccine. Such biomarkers could be used in future vaccine development programs to     optimize selection of vaccine candidates with a profile that will be unlikely to generate     worrisome safety signals once they are in generalized use.      This study is one in a series of training studies which will each use different licensed     vaccines that are prototypical representatives of a class of vaccine used in a particular     target population. Forty eight subjects will be randomised into three groups to receive: A)     Varicella zoster vaccine (n = 20), B) Yellow Fever vaccine (n = 20), C) Saline placebo (n =     8). Following a screening visit, participants will undergo a seven day residential visit     which will include immunization and intensive monitoring of physiological (e.g. heart rate,     oral temperature, blood pressure) metabolic and immune (innate and adaptive) parameters. This     visit will be followed up by four outpatient visits with further monitoring and blood     samples.   "
116181|NCT01765400|"     The investigators aim to determine if patients with systolic heart failure treated with     prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.   "
116182|NCT01765387|"     The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic     exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled     repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople     are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed     (control group) after complete a spinning session.   "
116183|NCT01765374|"     To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients     treated by rituximab.   "
116184|NCT01765361|"     Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also     includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are     partly independent of lesion formation and relapse activity , but represent the direct driver     of clinical long-term disability and cognitive decline.      Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor     EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and     numerical data which are closely correlated to the EDSS. As EP capture the functional     integrity of the examined systems they represent a method unbiased for directional changes,     while remaining specific for the neuronal function, and hence can measure deterioration, as     well as improvement, a germane advantage to capture drug response.      High-resolution electroencephalography (EEG) allow for explorative analysis of potential     surrogate markers for cognitive decline.      Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment     effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense     lesions as well as on the annualized relapse rate in a recent phase II trial in     relapsing-remitting MS.      The present study will investigate the effects of OCR on multimodal evoked potentials (EP),     Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue     will be explored.   "
116193|NCT01765244|"     Phase I- II clinical trial to evaluate the feasibility of the method and the absence of     relevant side effects derived from product implant.      HYPOTHESIS: Once designed the nanostructured artificial human corneas by the Tissue     Engineering Group of the University of Granada, and after evaluating their suitable     properties ex vivo and their in vivo utility by means of anterior lamellar keratoplasty in     laboratory animals, it is necessary to proceed to clinical evaluation in human patients     suffering from severe corneal pathology. The results obtained during pre-clinical study, both     in laboratory and in experimental animals, suggest that nanostructured artificial human     corneas could help to treat various corneal diseases that occur with any substance loss or     serious structural alteration, with no relevant side effects.   "
116194|NCT01765231|"     The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg     Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.   "
116185|NCT01765348|"     Specific-language-impairment (SLI) is defined as a significant disorder in language     development, which affects one's daily functioning, but not attributable to sensory,     intellectual or neuropsychological deficit. Children with SLI make up one of the largest     subgroups of students with special educational needs (SEN) in Hong Kong. Without appropriate     intervention, SLI may persist into adolescence and lead to long-term literacy difficulties     and social rejection, which were found to be associated with societal problems like     unemployment and crime commitment. Among the language domains, syntax/grammar has been viewed     as a core deficit in these children. Speech-Language-Pathologists (SLPs) often provide     intervention on this aspect for them. However, very few intervention efficacy studies could     be identified.      Without pertinent research evidence, clinical-decision-making in treatment approach selection     may be dubious. This study aims to evaluate the efficacy of two procedures for syntax     intervention, namely the Sentence-Combining (SC) and Narrative-Based (NAR) procedures using a     randomized-controlled-trial (RCT) design. These two procedures have been indicated to be     effective in previous case reports and expert opinions. By using the rigorous study design of     RCT, this study provides stronger evidence to support clinicians in determining the most     effective treatment procedure. To achieve sufficient statistical power to detect the     treatment difference, 52 children with SLI will be recruited and randomly assigned to one of     the treatment groups. The primary outcome will be measured by a standardized language     assessment. Intention-to-treat analysis will be employed. Pre- and post-treatment scores on     the outcomes will be subject to analyses of covariance with the pre-treatment scores as the     covariate.   "
116186|NCT01765335|"     HF represents a major burden in the developed world. Mortality and rehospitalization rates     post-discharge in patients admitted with HF may be as high as 15%-30% within 60-90 days,     respectively. Given that rehospitalization drives much of the cost associated with HF, there     has been increased interest in predicting risk of rehospitalization as a means to control     health care costs. These risk stratification models can serve as important clinical tools by     helping to identify those patients who are at very high risk may be observed more closely or     treated more intensively. The most important predictors for the combined endpoint of death or     rehospitalization were admission serum creatinine concentration, systolic blood     pressure,admission hemoglobin level, discharge use of ACE-Ior ARBS, and Pulmonary disease.     Other independent predictors during hospitalization of readmission and mortality included low     admission Kansas City Cardiomyopathy Questionnaire score, high BNP, hyponatremia,     tachycardia, hypotension, absence of b-blocker therapy, and history of diabetes and     arrhythmias. Nevertheless, both models fail to provide the treating physician a simple     decision making tool for predicting which patient is stable enough to be discharged from the     hospital without a high risk of readmission. The Non Invasive Cardiac System (NICaS, Israel),     calculates the cardiac output by measuring impedance cardiography in a tetra-polar mode,     derived from electrodes placed on both wrists or one wrist and the contra-lateral ankle. This     simple to operate, non-invasive technique was validated in a few studies to be reliable in     estimation of CO compared to traditional, invasive techniques in different settings including     HF patients. A previous study demonstrated that parameters derived from this system showed a     highly significant correlation to echo estimated EF and serum BNP in chronic HF patients and     were equally able to predict complications in this population. Aim:To assess whether the     NICaS system can identify high risk HF patient for readmission prior to their discharge     compared to serum BNP measurement.   "
116187|NCT01765322|"     The purpose of this study is to determine whether laser-assisted zona thinning improve the     implantation rate of the women of advanced age in the first IVF/ICSI cycles   "
116188|NCT01765309|"     Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin     during breast reconstruction with tissue expanders results in decreased pain using a blinded,     randomized, controlled trial.   "
116189|NCT01765296|"     -  6-week Efficacy Study The objective of this study is to prove the safety and          non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and          analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in          patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The          primary efficacy parameter is the difference from Baseline to Week 6 in the Western          Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale.        -  Extended Safety Study The objective of the Extended Safety Study is to collect a total          of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data,          and an additional 18 weeks of safety data for those subjects who agree on the consent          form to continue into the Extended Safety Study. Subjects will be administered CG100649          2 mg only during 18 weeks of Extended Safety Study.   "
116190|NCT01765283|"     The purpose of this study is to assess the safety and to appraise the efficacy of one cycle     of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in     paediatric patients suffering from CN or UCD.      The study duration: 12 months starting from the day of treatment: 6 months active     surveillance and 6 months observation post-infusion.   "
116191|NCT01765270|"     Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular     events (for example, heart attack) and the risk is related to one's overall control of blood     glucose levels. In this study the investigators will measure the effects of saxagliptin,     compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery.     The investigators will use samples of the patients' blood and tissue to measure and evaluate     indicators of the body's response to the treatment. This study is being done to evaluate the     effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or     controlling a person's blood glucose levels during and after CABG surgery will produce better     clinical outcomes (for example, better heart health).   "
116192|NCT01765257|"     Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD)     and/or in de novo patients, apathy is relatively frequent (estimated to 23%). However, the     neuropathological bases of apathy are still unknown. However, recent data suggests that     apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.      Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the     MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in     Parkinson's disease.      The primary outcome is to demonstrate a significant reduction of apathy using the Lille     apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease,     using a treatment by rasagiline.   "
116195|NCT01765218|"     We wish to see whether topiramate (an anti-epileptic agent) improves the outcome of babies     with neonatal hypoxic encephalopathy who are receiving whole body cooling.   "
116388|NCT01762462|"     Primary Objective:      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of     SAR302503.      Secondary Objective:      To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with     mild and moderate and hepatic impairment and in matched subjects with normal hepatic     function.   "
116196|NCT01765205|"     Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to     screen for left-sided cardiac lesions. These studies have shown that the occurrence of     critical congenital cardiac malformations among asymptomatic newborns is high; the technique     of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to     operate(requires little time and can be done in the newborn nursery) and is cost effective;     there is effective follow-up test (heart ultrasound) and available interventions have an     effect on outcome for diagnosed newborns. The importance of this research project is to     examine the overall helpfulness of measuring oximetry in newborn infants using somatic     oximetry, as well ast to prepare for a population based study in the state of Florida.   "
116197|NCT01765192|"     This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10     mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced     expiratory volume in the first second (FEV1).   "
116198|NCT01765179|"     The purpose of the study is to determine if oral testosterone undecanoate is effective and     safe in the treatment of low testosterone in men.   "
116199|NCT01765166|"     This Competing Renewal project continues the research and development of a parent-focused     intervention, Parent Guide to SSGRIN, which parallels an established child-focused     intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in     order to teach and reinforce the same social skills and concepts within the home environment.     A primary goal is to address questions of relative impact, longer-term treatment benefits,     and differential treatment effects of the Parent Guide training on children's social skill     development across settings and populations.   "
116200|NCT01765153|"     The objective of the study was to determine the efficacy of two forms of physical therapy     training, one emphasizing precise, visually guided walking over obstacles and on targets     (Precision Training), the other emphasizing mass practice of walking on a treadmill     (Endurance Training). The hypothesis was that visually guided training (Precision) may be     especially efficacious because it engages the motor cortex, whose input may facilitate     improvements in functional walking. Participants are individuals with a chronic (≥7 months     post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would     preclude participation in an intensive training program. A randomized, single-blinded,     cross-over design was used to randomly allocate participants to start with Precision or     Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed     by a 2-month rest period, identified as Rest Period I. Participants then returned for     2-months of training in the other method, identified as Training Phase II, followed by     another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence,     as well as depression were obtained at least 3 times before any training, then monthly     thereafter. Electrophysiological measures were taken before and after each phase of training     and period of rest. Change scores were used to determine how each phase of training and rest     influenced the scores (see below).   "
116201|NCT01765140|"     This is a continuing project to provide 3,4 diaminopyridine (DAP) under a treatment-use IND     to patients with Lambert-Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndrome     (CMS).   "
116202|NCT01765127|"     This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine     (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk     Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to     further investigate the safety profile of asenapine in clinical practice. The aim of this     study is to proactively capture safety and drug utilisation data in the post-marketing phase     of license approval of asenapine as prescribed to patients by general practitioners (GPs) in     England. This data is obtained through the completion of questionnaires by GPs.   "
116203|NCT01765114|"     The aim of this study is therefore to investigate the efficacy of the PEG-formulation to     reduce the frequency and duration of genital herpes recurrences, to assess its safety and     tolerability and to investigate its effect on shedding.   "
116204|NCT01765101|"     Using double blind, randomized controlled design to study the immediate, short-term and     intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles     and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis,     under the basis of International Classification Functioning, Disability and Health.   "
116205|NCT01765088|"     This study is being conducted to help determine whether the addition of     Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in     vivo and vitro, when given along with temozolomide during the monthly cycles that follow     radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly     diagnosed high-grade glioma.   "
116206|NCT01765075|"     The purpose of the study is to gather electrophysiological data using a multi-electrode     mapping catheter during a clinically indicated cardiac ablation procedure for the treatment     of persistent atrial fibrillation.   "
116207|NCT01765062|"     Many author have exposed the rapid and slow expansion, the diversity of activation and     containment protocols and the follow-up time, justify the need for more studies to evaluate     the effects to the ERM for the long-term.   "
116208|NCT01765049|"     Breast density change after short term use of aromatase inhibitor in postmenopausal ER     positive breast cancer would predict endocrine responsiveness   "
116221|NCT01764633|"     The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used     in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of     cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or     coronary revascularization in subjects with clinically evident cardiovascular disease.   "
116222|NCT01764620|"     The purpose of this study is to investigate the effects of muscle fatigue in the scapular     kinematics of overhead athletes with and without using a kinesio taping technique for     facilitating lower trapezius function. The hypothesis is that the taping technique could     compensate for the negative effects caused by muscle fatigue in the scapular kinematics of     healthy overhead athletes.   "
116447|NCT01761695|"     The investigators would like to propose a prospective longitudinal observational cohort study     for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan     Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other     retrospective analysis.   "
116209|NCT01765036|"     Ductal adenocarcinoma is the most frequent pancreatic solid lesion and the most common tumor     of the pancreas. Given its poor prognosis and the major therapeutic consequences, the     discrimination between PA and other pancreatic solid lesions is mandatory. EUS is admitted as     the most sensitive imaging procedure for the detection and characterization of pancreatic     tumors [1-3]. Nevertheless it remains difficult to differentiate, on morphological features,     PA from other solid masses. For 15 years, endoscopic ultrasound fine needle aspiration     (EUS-FNA) has demonstrated its efficiency for tissue sampling and cyto-histologic diagnosis     of PA. However, the negative predictive value (NPV) for the diagnosis of pancreatic     adenocarcinoma (PA) remains low (30-70%) in the published prospective series [4]. So, in case     of negative result, the choice between surgery and follow-up remains difficult. Additional     criteria to get the decision are then warranted.      The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in     real time with imaging specific methods seems useful to improve their characterization [4-8]     either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-enhanced harmonic EUS     (CH-EUS).      The aims of this prospective multicenter study is:        1. to compare the NPV of contrast-enhanced endoscopic ultrasound (CH-EUS) and EUS-FNA for          the diagnosis of PA;        2. to assess the intra- and inter-observer concordances of CH-EUS for the diagnosis of PA.   "
116210|NCT01765023|"     The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin     and metformin single or co-administered in healthy volunteers   "
116211|NCT01765010|"     The purpose of this study is to compare the effect of inactive and active vitamin D on serum     sclerostin and dickkopf1 levels.   "
116212|NCT01764997|"     Primary Objective:      To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to     etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response     to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).      Secondary Objectives:      To assess the signs and symptoms of RA in participants taking sarilumab in combination with     MTX.      To assess the quality of life of participants with RA taking sarilumab in combination with     MTX.      To assess the safety and tolerability of sarilumab in combination with MTX in participants     with RA.   "
116213|NCT01764984|"     Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an     estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans     will be affected by the disease. Despite the relative good track record of total knee     replacement, it remains a biomedical device that can fail over time. A recent study looking     at the current mechanisms of total knee replacement failures, listed polyethylene wear and     osteolysis around implants. The material used for polyethylene insert as well as the     conformity of articular surface of implants has been modified to decrease wear. While     introducing modularity, the usage of metal backing in tibial base plates became obvious as it     offered better stress distribution to the proximal tibial bone. However, it introduced other     modes of failures. Micromotion has been demonstrated between the metal backing and the tibial     liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision.     Factor influencing the surgeon's choice of implant include: reproductibility and longevity of     results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of     elasticity of the tibial base plate has a direct effect on periprosthetic bone biology.     Studies have described a significant decrease in postoperative Bone mineral density (BMD),     adjacent to the implants, after total knee replacement. No study, to our knowledge, has     looked at BMD in vivo after total knee replacement comparing different tibial base plate     designs. Direct effect of changes in design on overall implant survival can be studied with     randomized clinical trials isolating specific variables. No randomized clinical trial has     looked at tibial insert stiffness and modularity, and it effect on bone density changes,     synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study     variables, one would aim at randomizing an homogenous patient population undergoing total     knee arthroplasty with implants of similar articular geometry designs with different tibial     insert modularity and stiffness.   "
116214|NCT01764971|"     Intracranial hemorrhage despite being rare, several chronic ITP patients experience moderate     to severe behavioral problems including learning difficulties, memory affection .These     changes could be due to the presence of minute capillary dysfunction   "
116215|NCT01764958|"     The proposed research has the potential of contributing to the limited empirical literature     on the relationship between maternal sensitivity and motor development of preterm infants. If     indeed maternal attuned behaviors will be found to be associated with the quality of motor     development, such a finding will support the effectiveness of physical therapy in guiding     caregivers to attune their holding and touch of preterm infants.      We hypothesize that mothers and infants' attunement during observed interaction will be     related to the quality of preterm infants' spontaneous movements in the following ways:     First, better maternal attunement to the infants needs, and in particular attunement of     holding and touch will be associated with better quality of spontaneous movements of the     infants. Second, more initiations and/or involvement of infants in interaction will be     associated with better maternal attunement to the infant. Third, more initiations and/or     involvement of infants in interaction will be associated with better quality of spontaneous     movements and better achievements in developmental milestone. All hypotheses will be examined     while controlling for maternal use of SSC method during hospitalization after birth and     family demographic backgrounds.   "
116216|NCT01764945|"     The objective of the current study is to investigate the relative bioavailability of two     different doses of BI 201335, administered as soft gelatine capsule in comparison to the     equivalent doses of three different oral solution per dose of BI 201335.   "
116217|NCT01764932|"     In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will     determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.      Previous studies have drawn contradictory conclusions based the potential flaw assumption of     100% success rate for correct epidural catheter placement in the thoracic region.   "
116218|NCT01764919|"     This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic     imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.   "
116219|NCT01764659|"     The primary objective is to study the feasibility and efficacy of individually optimized CE     4D-CT for PDA in radiotherapy simulation.   "
116220|NCT01764646|"     RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and     effective than standard radiation therapy in treating prostate cancer.      PURPOSE: This protocol presents a randomised phase II study aiming to investigate the     tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate     cancer.   "
116448|NCT01761682|"     The investigators would like to propose a prospective longitudinal observational cohort study     for patients who will be diagnosed and/or treated for acute lymphoblastic leukemia at Asan     Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other     retrospective analysis.   "
116223|NCT01764607|"     Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in     contrast to the general population with basal and squamous cell skin cancer. The use of     immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase the     risk of developing certain kinds of cancer. The purpose of this study is to find out how well     Sirolimus (also known as Rapamune) works at treating squamous cell carcinoma in renal     transplant patients.   "
116224|NCT01764594|"     To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.   "
116225|NCT01764581|"     ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing     immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of     immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression.     The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte     activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive     therapy in adult liver transplant recipients to reduce the risk of adverse events   "
116226|NCT01764568|"     Current Canadian Clinical Practice guidelines emphasize the need for effective psychosocial     adjuncts to pharmacotherapy for schizophrenia (Canadian Psychiatric Association 2005). This     randomized control trial seeks to contribute to the body of evidence supporting psychosocial     treatments by assessing the effectiveness of metacognitive training (MCT) and cognitive     remediation (CR) at treating the persistent positive and cognitive symptoms of schizophrenia.     MCT is a therapy designed to improve patient awareness and insight into the cognitive biases     that are frequently seen in schizophrenia; it has been associated with decreased     psychopathology (specifically decreased positive symptoms) and improved psychosocial     function. CR is a therapy designed to improve performance in a variety of neurocognitive     functions such as attention, memory, and executive functioning; it has been associated with     improved cognitive and psychosocial functioning. Both MCT and CR will be compared to     treatment as usual (TAU) as done previously (Kumar er al., 2010; Moritz et al., 2011).      Hypotheses:        1. MCT will produce greater change in delusions (severity and conviction) than CR and TAU.        2. CR and MCT will produce greater change in social/everyday functioning than TAU.        3. CR will produce greater improvement in basic attention and memory measures relative to          MCT and TAU.        4. MCT will produce greater reduction on tasks measuring targeted reasoning biases relative          to CR and TAU.        5. CR will increase efficiency of functional networks on a working memory task relative to          MCT and TAU.        6. MCT will lead to a greater decrease in the neural response to evidence matches relative          to CR and TAU.   "
116227|NCT01764555|"     This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients     versus normal weight patients. Specifically the different metabolic pathways of acetaminophen     in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1     (cytochrome P450 2E1) oxidation   "
116228|NCT01764542|"     The purpose of this study is to study development of dysplasia in the ileal mucosa among     patients with Ulcerative Colitis and who previous have hade risk factors for developing     cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.   "
116229|NCT01764529|"     Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain     and spine. CCMs can bleed and cause strokes, seizures, and headaches. CCMs are often caused     by an inherited gene mutation (alteration) called CCM1. There is a wide range of disease     severity even among family members with this disease, though the natural history has not been     clearly described for this particular population.      This study will examine factors that influence disease severity through the collection of     blood samples, detailed medical histories, physical and neurological exam, and magnetic     resonance imaging (MRI) of the brain in medical records. The specific goals of this study are     to:        1. establish a registry/database of familial CCM cases with detailed clinical data,        2. perform genetic testing on participant blood samples to identify other genes that may          influence the development and hemorrhage of CCM lesions, and        3. determine lesion growth during the study.   "
116230|NCT01764516|"     This study was carried out with the purpose of evaluating zinc and selenium levels in serum     of epileptic patients and compare with normal individuals.   "
116231|NCT01764503|"     Adenoma of the ampulla of Vater is rare but represents a large proportion of benign tumors     occurring in the small intestine. The symptoms are usually non specific or due to     pancreaticobiliary obstruction . The diagnosis can also be made in asymptomatic patients     during an upper gastrointestinal endoscopy. Finally, the adenoma can be discovered during a     screening procedure in patients with Familial Adenomatous Polyposis (FAP).      It has been demonstrated that ampullary adenomas have a malignant potential mimicking the     adenoma-adenocarcinoma sequence already described in the colon. So, a complete removal is     mandatory. The only exception is represented by subnormal ampulla with low grade dysplasia     (LGD) adenoma discovered during screening follow-up of FAP patients. In these cases the     situation can be stable during several years leading to simple, annual or biannual     surveillance. Historically, the treatment was surgical, associated with a high mortality and     morbidity rate for pancreaticoduodenectomy (PD) and a high recurrence rate for transduodenal     resection (26 to 43%). Endoscopic papillectomy (EP) represents an alternative for patients     with a benign or at least non-invasive ampullary tumor. Unlike thermal ablative methods by     laser photoablation or argon plasma destruction, EP allows adequate histologic evaluation     especially in case of en-bloc resection. This technique has been increasingly used in the     last decade with very promising results. Nevertheless the long-term results have mainly been     reported in retrospective monocentric series.      We intended to evaluate, in the first large multicenter prospective study, the long-term     results of endoscopic papillectomy.   "
116266|NCT01764048|"     Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for     the mother to nurture the newborn child and establishing an appropriate mother-child bonding.     Therefore, effective pain management is crucial. In this study we would like to compare     between two pain relievers' administration protocols: (1) pain relievers' administration in     fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration     following demand (the same type and doses, however, medications will be given only following     patient's request).      The primary outcome will be patient satisfaction, pain control and the necessity of     additional medications (rescue doses).      The protocols will be used for the first 48 hours following surgery.   "
116232|NCT01764490|"     Main objective: to observationally assess the efficacy of different antimicrobials in     Bloodstream Infection (BSI) due to Enterobacteriaceae producing ESBLs or carbapenemases.      Specific objectives:      Bacteraemic infections due to ESBL-producing Enterobacteriaceae:        -  To demonstrate that β-lactam/β-lactam inhibitors are not associated with worse cure rate          and mortality than carbapenems after controlling for confounders, both as empirical and          definitive therapy.        -  To demonstrate that fluoroquinolones as definitive therapy are not associated with worse          cure rate and mortality than carbapenems after controlling for confounders.        -  To demonstrate that empirical cephalosporins in monotherapy are associated with worse          cure rate and mortality than carbapenems after controlling for confounders in infections          others than urinary tract infections.        -  To demonstrate that the association of active aminoglycosides with cephalosporins or          fluoroquinolines is not associated with worse cure rate and mortality than carbapenems          after controlling for confounders.        -  To demonstrate that combination empirical and definitive therapy is not associated with          better cure rate than monotherapy after controlling for confounders.        -  For tigecycline, colistin, and fosfomycin, no hypothesis. The objective is to provide          adjusted estimations of their association with outcome variables in comparison with          carbapenem monotherapy according to clinical situation and infection.      Bacteraemic infections due to carbapenemase-producing Enterobacteriaceae:        -  To demonstrate that combination therapy is associated with worse cure rate and mortality          than monotherapy after controlling for confounders.        -  To show that carbapenems are associated with worse cure rate and mortality when used in          infections other than urinary tract caused by isolates showing MIC <2 µg/mL for imipenem          or meropenem in comparison to those caused by isolates with higher MIC, after          controlling for confounders.        -  To show that colistin used at a dose >6 million IU per day is associated with improved          outcomes in comparison with lower dose, after controlling for confounders.   "
116233|NCT01764477|"     Laboratory studies suggest that the study drug may stop cancer cells from growing by     affecting an interaction between proteins in the cells referred to as cAMP-response     element-binding protein and ß-catenin.      The purpose of this research study is to determine the highest safe dose of study drug that     may be used when it is given together with a chemotherapy drug to patients with cancer of the     pancreas.   "
116234|NCT01764464|"     Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)   "
116235|NCT01764451|"     Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain     and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs     affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its     contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of     this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using     a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI).     The purpose of this study is to look at whether statin medications change the permeability     (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower     cholesterol levels and prevent heart attack and stroke. In addition, this medication may     decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will     examine whether the permeability of the BBB changes following the administration of     simvastatin for three months.   "
116236|NCT01764438|"     Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhanced MRI can affect on BCLC staging during the     initial staging workups of definite HCC patients with very early or early stage disease, but     with no suspicious intrahepatic HCC lesions by liver dynamic CT.   "
116237|NCT01764425|"     Clinical trial to study the safety tolerability, pharmacokinetics, food effect and     pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects   "
116238|NCT01764412|"     Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron     stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.      The interpretation of hepcidin dosage results requires to know the physiological variations     of this hormone.      This study investigate whether there are significant variations in the values of serum     hepcidin rates during the menstrual cycle in order to make recommendations on the practical     dosage determination of hepcidin in premenopausal women.   "
116239|NCT01764399|"     Older adults caring for others often neglect their own health. This research is being done to     see if helping caregivers focus on their own needs can improve their health and ability to     care for others   "
116240|NCT01764386|"     The purpose of this Phase 3b study is to assess the effects of combination therapy with     naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle     intervention (CLI) and in a manner consistent with its intended use after marketing approval,     on body weight and cardiovascular risk factors compared to the effects of Usual Care in     subjects who are overweight with dyslipidemia and/or controlled hypertension or obese.     Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment     at Week 16. Subjects are to be discontinued from full participation if they do not lose at     least 5% of their body weight relative to baseline and/or are experiencing sustained     increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26,     subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects     assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment     period).   "
116241|NCT01764373|"     This is an amendment to study posting NCT00970060. Based on preliminary results from that     study is was determined there needs to be a follow-up exercise intervention study. This study     has two additional aims than the original study. The objectives are to determine is a     prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness     positively impact people with diabetic neuropathy.   "
116242|NCT01764360|"     Kaposi sarcoma (KS) is an AIDS-related cancer and is the most commonly reported cancer in     Zimbabwe. If it is found early on, it may be treatable with antiretroviral therapy (ARVs)     alone and this will improve general well-being and ease of care. It may also be possible to     avoid use of expensive chemotherapy if the KS is picked up early on in the course of the     disease. Early KS is often overlooked or not recognized by health professionals. The purpose     of the study is to learn more about if the level of medical care and treatment provided at     primary care clinics in Zimbabwe will help people with AIDS-KS do better and maintain their     health longer. This will be done by monitoring how KS is diagnosed and treated at the primary     care clinics. Clinics will then have training in how to recognize and treat KS so that they     can better identify and care for patients with the disease.   "
116243|NCT01764347|"     This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound     (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with     prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy     may help find and diagnose prostate cancer   "
116267|NCT01764035|"     The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS)     meditation intervention for individuals with bipolar I disorder with insomnia (i.e.     difficulties falling or staying asleep). The investigators will compare the Body Scan     intervention with a 4-session brief supportive psychotherapy (SP) intervention. The     investigators hypothesize that the Body Scan will improve objective sleep quantity and     quality.   "
116534|NCT01760564|"     To evaluate the changes in cognitive function after miglustat treatment in Niemann-Pick type     C patients.   "
116244|NCT01764334|"     Background: In patients with acute non-ST elevation myocardial infarction (NSTEMI) coronary     arteriography is usually recommended however visual interpretation of the coronary angiogram     is subjective. A complementary diagnostic approach involves measuring the pressure drop     across a coronary stenosis (fractional flow reserve, FFR) with a pressure-sensitive     guidewire.      Hypothesis: Routine FFR measurement is feasible in NSTEMI patients and has additive     diagnostic, clinical and health economic utility, as compared to angiography-guided standard     care.      Design: A prospective multi-center randomized controlled trial in 350 NSTEMI patients with ≥1     coronary stenosis ≥30% severity (threshold for FFR measurement). Patients will be randomized     immediately after coronary angiography to the FFR-guided group or angiography-guided group     (FFR measured, not disclosed). All patients will then undergo FFR measurement in all vessels     with a coronary stenosis ≥30% severity. FFR will be measured in culprit and non-culprit     lesions in all patients. FFR will be disclosed to guide treatment in the FFR guided-group but     not disclosed in the 'angiography-guided' group. In the FFR-guided group, an FFR>0.80 will be     an indication for medical therapy whereas an FFR≤0.80 will be an indication for     revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass     surgery (CABG), as appropriate. The primary endpoint is the between-group difference in the     proportion of patients allocated to medical management compared to revascularization. A key     secondary composite outcome is the occurrence of cardiac death or hospitalization for     myocardial infarction or heart failure. Other secondary outcomes include quality of life,     hospitalization for unstable angina, coronary revascularization or stroke, and healthcare     costs. Exploratory analyses will also assess the relationships between FFR and angiographic     lesion characteristics (severity, culprit status). The minimum and average follow-up periods     for the primary analysis are 6 and 18 months respectively. A secondary analysis with longer     term follow-up (minimum 3 years) is planned. Screen failures who gave informed consent will     be entered into a registry.      Importance: Our developmental clinical trial will address the feasibility of FFR measurement     in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic     outcomes.   "
116245|NCT01764321|"     This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to     compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients     treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF)     inhibitor.   "
116246|NCT01764308|"     60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic.     Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day     for 24 weeks.   "
116247|NCT01764295|"     The purpose of this study is to evaluate the efficacy and safety of DWJ1276   "
116248|NCT01764282|"     The purpose of this study is to evaluate the effectiveness of reducing HIV transmission among     sero-discordant couples by applying comprehensive intervention components.   "
116249|NCT01764269|"     In this study, the investigators will prospectively assess fever rates in 24-59 month old     patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live     attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these     vaccines as part of their routine care can enroll in this study if their parent has the     ability to receive and send text messages. Children enrolled in this study will be observed     for an eleven day period starting on the day of vaccine administration via a series text     messages to their parents.   "
116250|NCT01764256|"     This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult     volunteers to determine if it is safe and if the immune systems of healthy adults respond to     this vaccine.   "
116251|NCT01764243|"     The objective of this study is to evaluate the safety and efficacy as assessed by the     Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of     MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate     Alzheimer's disease.   "
116252|NCT01764230|"     Chemotherapy as one of the basic modalities of oncology treatment often leaves permanent     implications and among the most common is infertility as a result of irreversible gonadal     damage. This project sets the primary target to verify the protective effect GnRH analogues     administration to protect ovarian tissue during three different regimens of chemotherapy in     patients with Hodgkin disease (HD) in reproductive age.   "
116253|NCT01764217|"     Observational study based on the routine clinical treatment and diagnostic course, to     correlate imaging features with outcome objectives. Outcome will evaluated as clinical     response to the standard treatment and as recurrence and survival in the follow up. The study     hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can     predict outcomes following standard treatment.   "
116254|NCT01764204|"     To highlight the incidence of adverse reactions of Qingkailing Injection.   "
116255|NCT01764191|"     This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS)     with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently     available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which     may more accurately diagnose the presence of CS. This study will also provide additional data     to further examine the effectiveness and safety profile of 18F FDG for this condition.     Accurate and early detection is important to allow for better management of CS and improve     patient care.      The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with     clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety     and effectiveness of 18F-FDG PET/CT in this patient population   "
116256|NCT01764178|"     The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan     co-administration and Livalo fixed combination drug in healthy male subjects.   "
116257|NCT01764165|"     This research is being conducted to examine the effects of nasal insufflation of warm and     humidified air through a small nasal cannula on sleep, breathing pulmonary function, and     daytime exercise capability.   "
116258|NCT01764152|"     This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised     with laboratory-confirmed influenza through a network of hospitals in France   "
116268|NCT01764022|"     BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN:     trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast     cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the     non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes     pharmacokinetics assessment.   "
116269|NCT01764009|"     The objective of the present trial is:        -  to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and          recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in          patients with advanced or metastatic melanoma.        -  to determine the local and general safety of intramuscular electrotransferred Plasmid          AMEP        -  to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP   "
116270|NCT01763996|"     The purpose of this study is to assess the effect of febuxostat on coronary artery flow in     patients with coronary artery disease.   "
116259|NCT01764139|"     Vitamin D deficiency has long been linked to musculoskeletal pain, and many other chronic     disease conditions. Vitamin D is a nutrient that functions as a hormone precursor, and     wide-ranging health effects are supported by the presence of vitamin D receptors in several     cell types and tissues of the body (eg, lymphocytes and monocytes, brain, heart, pancreas,     intestine, and placenta).In addition to its essential role of maintaining bone health,     hypovitaminosis D has been implicated in the development of serious conditions, including     diabetes, various types of cancer, and cardiovascular diseases.      Vitamin D is a unique prohormone that humans obtain in small amount from food, dietary     supplements and largely by endogenous skin synthesis from 7-dehydrocholesterol with sunlight     exposure. This endogenous synthesis produces the form vitamin D3 (cholecalciferol).Vitamin D     deficiency and insufficiency are very common in the UK. Local audit at Chelmsford has shown     severe deficiency of vitamin D among chronic pain patients.      The major source of vitamin D synthesis relies on sunlight exposure which is likely to be     affected by modern lifestyles, which increasingly involve working indoors during daylight     hours. This may be particularly important when combined with residence in northern latitudes     and a cloudy climate.The proposed pilot study aims to identify percentage of vitamin D     deficiency among knee pain patients by investigating eligible patients' blood for '25 hydroxy     vitamin D'.      English speaking patients whose knee pain has not been resolved following knee arthroscopy     are eligible for the study. Study will be carried out at the Broomfield hospital chronic pain     department.      Duration will be around 6 months.   "
116260|NCT01764126|"     This is an observer-blind, randomised, vaccine-controlled, vaccine trial to determine the     safety and immunogenicity of a pneumococcal protein vaccine. It will use an age step-down     approach beginning with adults, then toddlers then infants, with data safety review at each     stage before stepping down to the next age group. Adults and toddlers will receive the same     dose of this three-protein (trivalent) vaccine (PcpA, PhtD, and PlyD1 proteins) at 50µg each.     Infants will then be started at a low dose (10 µg), then medium dose (25µg) then high dose     (50µg), with safety reviews at each stage before ascending to the next highest dose. Infants     will also receive concomitant standard EPI childhood vaccines. Safety will be assessed by     close monitoring beginning on the day of vaccination (day 0) and for the subsequent seven     days, with recording of solicited and non-solicited adverse events. Immunogenicity will be     assessed by specific antibody response to the three proteins. The study aims to recruit 280     study subjects across all age groups.   "
116261|NCT01764113|"     This study is designed to study the effect of a family based mindfulness training program     with special focus on diet and nutrition on weight and cardiovascular risk markers in obese     adolescents.   "
116262|NCT01764100|"     This is a bicentric, prospective, non randomized study. Pediatric and adult patients will be     treated.      Rationale: MSC have shown promising effects by reversal of severe therapy-resistant acute     GvHD. As a common therapeutic line of action is not shared for steroid resistant GVHD, it is     important to establish the toxicity and the feasibility of preparation and infusion of third     party MSCs for acute steroid resistant GVHD and acute phases of chronic steroid resistant     GVHD.      A total of 10 patients (pediatric and adults) need to be enrolled in the study. Patients who     present clinical signs of either acute or chronic steroid resistant GVHD will receive by     intravenous infusion at least two fixed doses of mesenchymal stem cells with 5 to 7 days of     interval one from the other, derived from HLA unrelated donor different from the HSC donor     (third party donor) regardless of the rate of HLA mismatch.      Primary objectives are to establish the feasibility and the toxicity of preparation and     infusions of third party MSCs for the treatment of steroid resistant acute and acute phases     of chronic grade II-IV GVHD.      Secondary objectives are:        1. To document the efficacy of MSC infusion in steroid resistant acute and acute phases of          chronic GVHD grade II-IV.        2. To document the rate of GVHD recurrence in MSCs infused patients.        3. To document relapse of hematological malignancies post MSC infusions in patients          undergoing MSCs treatment for steroid refractory GvHD.        4. To document the overall survival of MSC infused patients for steroid refractory GvHD.   "
116263|NCT01764087|"     The primary objective of this study is to determine the maximum tolerated dose (MTD) of     KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in     combination with paclitaxel in patients who are diagnosed as gastric and breast cancer,     respectively in Phase II.   "
116264|NCT01764074|"     Individuals with bipolar disorder (BD) experience extreme mood swings, or episodes of     depression and (hypo)mania. These episodes are associated with poor functioning, worse course     of illness, and high rates of suicidality. It is estimated that between 25 to 65% of     individuals with BD attempt suicide and 4 to 19% of individuals with BD eventually die by     suicide. Sleep disturbance has been identified as a primary prodromal as well as causal     symptom of mood episodes and recently, has been found to be associated with higher rates of     suicidal ideation and behavior. Given the role that sleep may have in mood stability and     suicidality in BD, it seems imperative to further understand the association of sleep and     suicide and how sleep interventions may be useful to reduce suicidality in BD. Thus, the     primary aim of this study is to use an innovative home sleep monitoring device, or the Embla,     to examine the association of sleep and suicidality in adult outpatients with BD. The Embla     is unique in that it is a non-invasive device that can characterize sleep profiles by     measuring the degree of sleep fragmentation and percentage of rapid eye movement (REM) sleep.     The study duration is five to six weeks such that patients wear the Embla device for Week 1,     participate in a brief sleep intervention for suicide during Weeks 2 and 3, and 4, and then     wear the Embla device for one more week (Week 5). This intervention consists of three, 60-min     sessions and utilizes cognitive-behavioral therapy strategies (e.g., psychoeducation,     cognitive re-structuring, problem solving, behavioral activation) to improve sleep     disturbance. The investigators expect that individuals at study entry with more sleep     disturbance (as measured by the Embla) will report more suicidal ideation and behaviors. The     investigators also hypothesize that from pre- to post-intervention, individuals will report     less sleep disturbance as well as suicidal ideation and behaviors. Data from this research     has immediate and practical implications for providers and their patients as it the first     examination of sleep phenotypes and suicide in a high risk population as well as to explore     the association of improvements in sleep with suicidality.   "
116265|NCT01764061|"     The purpose of this study is to validate that single units of RBCs collected by the     Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red     cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood     cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using     LN832 disposable sets for this intended use.   "
116386|NCT01762488|"     The purpose of this double-blind, randomized and sham controlled study is to investigate the     blood pressure lowering effect of renal denervation by catheter based ablation in the renal     arteries in patients with milder forms of treatment resistant hypertension. The effect on     blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at     baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises     hemodynamic assessment by applanation tonometry and the cold pressor response.   "
116271|NCT01763983|"     High levels of psychological stress have been reported by 90% of patients with MS     experiencing disease exacerbation, and approximately 39% of those with more stable disease     course. These stress levels are comparable to patients with a clinical diagnosis of major     depression. Cognitive dysfunction affects approximately 40% of community surveyed MS     patients, and stress may exacerbate the cognitive burden. Studies have shown that Cognitive     Behavior Therapy (CBT) is effective in treating psychological stress. Studies have also shown     that exercise is beneficial to mood and cognitive function. Therefore the proposed study will     test the comparative benefits of combining CBT and Exercise as an intervention for stress and     cognitive dysfunction in MS subjects. The 2 active treatment conditions will be compared with     a waitlist control condition.      There are 4 broad aims to this study: 1) to compare the relative efficacy of CBT, Exercise,     and CBT-Exercise for stress in MS, 2) to examine the extent to which neuropsychological     features of stress and MS, especially working memory and executive functioning, improve     following treatments, 3) to determine the extent to which neuropsychological factors are     associated with successful treatment response and improved quality of life, and 4) to     determine if combined CBT-Exercise confers greater benefits on measures of stress and     neuropsychological functioning compared with Exercise alone.      The study hypotheses are: 1) All active treatment conditions will lead to significantly     greater improvement on measures of stress at post-treatment and follow-up compared to     waitlist controls, 2) Combined CBT-Exercise will lead to comparatively greater symptom     reduction compared to all other conditions at post-treatment and follow-up assessments on     measures of stress, 3) All active treatment conditions will lead to significant improvement     in neuropsychological functioning (particularly measures of working memory and executive     functioning) at post-treatment compared to controls, and 4) Combined CBT-Exercise will lead     to greater improvement in neuropsychological functioning compared to all other conditions at     post-treatment.      The study design allows for examination of the potential additive benefits of CBT and     Exercise to usual therapy for patients, and its feasibility as a viable treatment model for     MS outpatient clinics and community-based intervention programs. This study will shed light     on the treatment of sub-threshold symptoms that are strikingly common in MS population, but     often overlooked in favour of more concrete diagnoses (e.g. major depression disorder). This     proposed study will also be the first to determine whether evidence-based non-medical     treatments for stress and mood disturbances in MS reduce underlying cognitive substrates     associated with the illness and known to be exacerbated by stress.   "
116272|NCT01763970|"     The SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in the     adult population. However, SBRT (stereotactic body radiation therapy) has a particularly     strong rationale for application in pediatrics given that high biologically effective doses     have been shown to increase control in histologies, such as sarcoma, which are common in the     pediatrics population (11,25). With stereotactic radiation therapy techniques, a reduction in     normal tissue dose surrounding the target lesion of interest may also be accomplished     resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with     limited metastases in lung and bone, are still considered to be a curable population with     aggressive local therapy, SBRT could have a significant impact on outcomes in oligometastatic     patients who may be otherwise unresectable (25-28).   "
116273|NCT01763957|"     The Investigators decided to examine whether the Paula method is more effective than Pelvic     Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test     in menopause women without an hormonal therapy. In addition to the pad test and two urinary     incontinence questionnaires, we will use other assessment tools such as; quality of life and     sexual function which have been found to correlate significantly with pad test results. These     results may indicate that menopausal women with Stress Urinary Incontinence may be more     successful controlling incontinence if they will practice the Paula method as compared to     PFMT.   "
116274|NCT01763944|"     No treatments have been shown to slow prostate cancer progression after radical     prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer     growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary     treatment will be recruited and randomized to either a low-carbohydrate diet (<20 grams     carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome     is PSA doubling time.   "
116275|NCT01763931|"     The purpose of this study is to learn what effects digoxin may have on human breast cancer     tissue.   "
116276|NCT01763918|"     The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously     once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from     baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial     hypercholesterolemia (HeFH).   "
116277|NCT01763905|"     The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab     every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from     baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable     to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A)     reductase inhibitors).   "
116278|NCT01763892|"     The aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-E     (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify     or ameliorate secondary injury, for children with a traumatic brain injury. Exploring the     apo-E genotype will help us know if injury response is altered in certain children and will     aid in developing interventional approaches.   "
116279|NCT01763879|"     The use of pressure controlled ventilation (TV) during one lung ventilation (OLV) for     thoracic surgery is associated with comparable oxygenation with volume controlled ventilation     (VCV) with added benefits of decreasing airway pressures and shunt fraction. The later may     improve the right ventricular (RV) function during OLV. We postulate that the use of PCV     during OLV for thoracic surgery would preserve RV function than during VCV. After local     ethics committee approval and informed consent, we will randomly allocate 28 patients     scheduled for elective thoracic surgery OLV to randomly crossed from PCV to VCV mode (n= 14     for each) during with VT of 6 mL/kg, I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment     maneuvers and respiratory rate will be adjusted to maintain normocapnia. Intraoperative     changes in the right ventricular function (peak systolic and diastolic tricuspid annular     velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional area     changes (RV-FAC)), hemodynamic and oxygenation parameters, peak and plateau airway pressures,     compliance will be recorded.   "
116280|NCT01763866|"     The primary objective was to evaluate the effect of 12 weeks of evolocumab administered     subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin,     compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol     (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.   "
116369|NCT01762709|"     The use of low tidal volume (TV) during one lung ventilation (OLV) for thoracic surgery     decreases the incidence of postoperative acute lung injury (ALI). We postulated that the use     of low TV during OLV for video-assisted thoracoscopic surgery (VATS) would decrease the     extravascular lung water content index (EVLWI). After local ethics committee approval and     informed consent, we will randomly allocate 60 patients scheduled for elective VATS to     ventilate the dependent lung with VT of 4, 6, or 8 mL/kg (n= 20 for each), I: E ratio 1: 2.5,     PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain     normocapnia. Perioperative changes in EVLWI, hemodynamics, oxygenation index will be     recorded. Also, the incidence of postoperative ALI, morbidity, hospitalization and mortality     will be recorded   "
116281|NCT01763853|"     The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress     syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon     that the intensivist must recognize early and treat promptly. Fluid challenge may have     adverse side effects associated with fluid administration. The diffusion within the     interstitial space may favor edema formation and cause cardiac dysfunction by volume     overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial     integrity, leading to enhanced alveolar edema and impaired gas exchange.      Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids     and compared to crystalloids, albumin has the theoretical advantage of causing greater volume     expansion.      We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary     edema than a fluid resuscitation therapy with crystalloids.      The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema     fluid resorption, in 2 groups of patients: those treated with albumin and those treated with     crystalloid.   "
116282|NCT01763840|"     The research protocol aims to compare the utility of contrast enhanced abdominal sonography     with computerized tomography in the evaluation of children with blunt abdominal trauma.     Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the     trauma service with a CT scan of abdomen & pelvis already performed at the referring     institution will be identified by the trauma service as eligible for inclusion.      The ultrasounds will be performed by one of two Attending Radiologists involved in the study.     The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is     an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in     echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal     and pelvic solid tumors. The contrast enhanced ultrasound will be performed by radiologist.     Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be     redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be     monitored for 30 minutes after the contrast agent is given and any adverse reactions will be     recorded. Adverse reactions to Optison have occurred within this time frame in the     literature. Subsequent medical care will be as indicated per the clinical practice guideline.   "
116283|NCT01763827|"     The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC)     monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on     percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a     10-year Framingham risk score of 10% or less.   "
116284|NCT01763814|"     Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of     three groups, each group will use a different approach using the ultrasound to guide the     femoral nerve block as part of their treatment for controlling pain post-operatively.   "
116285|NCT01763801|"     Intravenous electrocardiographic guidance (IVECG) is a safe, reliable and accurate technique     to correctly position the catheter tip. The investigators sought to evaluate the superiority     of the P-maximal (P-max) wave compared to the P-submaximal (P-submax) wave in obtaining a     more correct, safer and longer lasting device placement, with a lower incidence of     complications and secondary misplacement.   "
116286|NCT01763788|"     The purpose of the Phase 1b portion of the study is to investigate how the body tolerates     necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line     treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose     for the subsequent Phase 2 portion of the study.      The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in     combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV     squamous NSCLC in a first-line setting.   "
116287|NCT01763775|"     The clinical protocol of the clinical testing of this device:        1. Objective of the test: To verify the functions and efficiency of devices.        2. Test methods and procedures: Comparison Test.        3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-1251-B, BF-1255-B,          BF-1256-B, and GBF-1257-B.        4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.        5. Study endpoints: DUT and the comparison device are substantial equivalence.        6. Statistical methodology used: Description of statistical methods.   "
116288|NCT01763762|"     The purpose of this study is to determine whether electrical pudendal nerve stimulation is     more effective than pelvic floor muscle training with Transvaginal electrical stimulation in     treating female stress incontinence.   "
116289|NCT01763749|"     The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of     Plavix with Astrix.   "
116290|NCT01763736|"     The objective of this research study is to assess the effects of music on patients'     experience in the Intensive Care Unit (ICU). The hypothesis of this study is that patients     who receive music therapy will report a reduction in negative recollections and experiences     while on mechanical ventilation and will require fewer pharmacologic agents to maintain their     sedation.   "
116291|NCT01763723|"     This studies was designed to investigate the importance of skin type and UV-exposure on side     effects after exposure to an Intense Pulsed Light Home-use device.      21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly     IPL-exposures.   "
116305|NCT01763541|"     There is gender dimorphism in cardiovascular risk, with men at higher risk than women.     However, the fundamental basis for the protective effect of female sex remains unclear.     Recent data implicate the natriuretic peptide (NP) system as an important determinant of     blood pressure. Also, NP levels are twice as high in women of reproductive age than in men,     and gonadal steroids are important determinants of circulating NPs. These are the marked, but     poorly understood differences in the NP status between men and women. The investigators     hypothesize that gonadal steroids regulate NP release, specifically that testosterone     inhibits and estrogen activates the NP axis, leading to differences in both resting NP levels     and dynamic responses of the NP, RAAS, and kidneys to acute and chronic salt loading.     Understanding the basis for gender differences in NP function should provide important     insights regarding mechanisms underlying hypertension in men versus women.   "
116306|NCT01763528|"     The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP     among overweight and obese women.   "
131697|NCT01561196|"     The aim of the project is to compare two methods for arterial cannulation. The traditional     method with ultrasound guided cannulation. The investigators goal is to improve this     procedure to reduce pain and complications.   "
116292|NCT01763710|"     Nanomedicines are currently being developed in the treatment of cancer due to their     pharmacological advantages over traditional formulations; they provide a shorter infusion     time and lower risks of hypersensitivity reactions associated with commonly used solvents.      Nab-paclitaxel is a nanoparticle albumin-bound particle form of paclitaxel that is thought to     exploit natural albumin pathways to enhance the selective uptake and accumulation of     paclitaxel at the site of the tumour, thus reducing its diffusion to normal tissues.      Nab-paclitaxel has been approved for the treatment of metastatic breast cancer patients who     have failed first-line treatment for metastatic disease and for whom standard,     anthracycline-containing therapy is not indicated.      SPARC is a cysteine rich acid protein that is overexpressed in a broad proportion of solid     tumours. Expression of this protein could sensitize tumour cells to antitumor activity of     Nab-paclitaxel, due to its union through albumin-binding to this protein.      First-line clinical trials have been developed with different Nab-paclitaxel regimens and     also in combination with different chemotherapies and trastuzumab, showing a high level of     efficacy.      Toxicity profile of Nab-paclitaxel is well characterized with significantly less     haematological toxicities compared with conventional paclitaxel.      Nab-paclitaxel derived grade III neuropathy is short-lasting and more reversible than     conventional paclitaxel-derived neuropathy, probably due to absence of Cremophor solvent, or     due to paclitaxel itself.      However there is still a lack of clinical and physiological characterisation of     Nab-paclitaxel induced neuropathy.      The current used tools for early detection and continuous evaluation of neurotoxicity are not     optimal. Most used toxicity scales are limited, as they do not provide a detailed information     of the severity of the neuropathy, its impact on quality of life, or physiopathology     mechanisms.      In addition, an inter-individual variability exists in terms of neurotoxicity predisposition     when taxanes are used; it could be related to polymorphic differences in genes implicated in     transport and metabolism of these drugs.   "
116293|NCT01763697|"     This study will investigate the effects of acute morphine administration on taste acuity and     how much a person eats. It is hypothesized that there will be a dose dependent decrease in     taste acuity and dose dependent increase in food intake associated with acute morphine     administration. Knowledge from this study will impact the future of feeding behavior and     obesity research in the general population. Results will also promote exploration of the     long-term effect of opioid abuse on taste acuity and feeding behavior in substance abusing     populations.   "
116294|NCT01763684|"     This study will compare alignment criteria in the Oxford Partial Knee using conventional     instrumentation and Signature Custom Guides in order to determine if the use of the Signature     Custom Guides results in a higher percentage of knees achieving optimal alignment. The study     will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons     (<10 cases/year).   "
116295|NCT01763671|"     The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to     docetaxel.      Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by     numerous clinical trials but sometimes toxicities are difficult to manage.      Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in     association with platinum in first ligne. Different clinical and preclinical data suggest     that there could exist a synergy between paclitaxel and bevacizumab. This association is     already used in metastatic breast cancer, it permits almost to double the response rate and     progression free survival. In lung cancer, the association was evaluated by two retrospective     studies which demonstrated a benefit with a favourable safety profile.   "
116296|NCT01763658|"     Oxidative stress occurs as a result of increased activity of free radical-producing enzymes,     decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants.     The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity,     increased cell fragility, and a shortened cellular life span results from oxidation of cell     membrane lipids.   "
116297|NCT01763645|"     BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN:     bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in     inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The     purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021     compared to Avastin. Also study includes pharmacokinetics assessment.   "
116298|NCT01763632|"     Thirteen hospitals in China will participate in the study, which aims to provide data on     transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and     late-preterm neonates, and develop an hour-specific TcB nomogram.      The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal     hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up     for hyperbilirubinemia in newborns.   "
116299|NCT01763619|"     This study will collect clinical and radiographic data on the Freedom Cervical Disc to     monitor the device's safety and performance as part of a post-market evaluation.   "
116300|NCT01763606|"     Patients with cancer who develop stroke are at high risk for future strokes or other clotting     events. These patients are routinely treated with medicines that thin their blood, including     enoxaparin or aspirin. However, it is unclear which medicine is best and whether these     medicines can be adequately studied in a clinical trial.      The purpose of this Phase I/II study is to determine if a clinical trial of different blood     thinners in patients with cancer and stroke is possible. In addition, the study aims to     compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with     cancer and recent stroke.   "
116301|NCT01763593|"     To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by     Aurolab.   "
116302|NCT01763580|"     To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid     with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.   "
116303|NCT01763567|"     The purpose of this study is to assess safety and device performance of the Medtronic     Hospital Glucose Management System (HGMS) for up to 72-hours.   "
116304|NCT01763554|"     Review of the medical files of 69 patients with neuroendocrine tumours who were treated at     the CCI from January/10 - July/12 with Lutetium-177 DOTA-TATE under Health Canada's Special     Access Programme (SAP). Efficacy, safety, and other relevant data will be collected.   "
116307|NCT01763515|"     Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing     age. This study will be performed in the purpose of determination the effects of laterally     wedged insoles on symptoms reduction of patients with knee osteoarthritis.   "
116370|NCT01762696|"     The purpose of this study is to further develop and test the Momentary Self-Monitoring and     Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual     intervention to reduce marijuana use among primary care patients.   "
116387|NCT01762475|"     The purpose of this study is to determine whether sildenafil (Viagra®) is effective in     improving cerebral blood flow and cerebrovascular reactivity inpatients who have persistent     symptoms at least 6 months after a traumatic brain injury (TBI).   "
116308|NCT01763502|"     Recent evidence shows that early childhood is a critical period for investments in human     capital and that micronutrient deficiency and inadequate stimulation are major causes of     impaired child development in poor countries. These findings have increased interest in     promoting nutrition interventions and preschool participation during early childhood.     Transfers to households linked to preschool participation have the potential to improve     nutrition and cognitive outcomes in young children. Receipt of transfers may induce     improvements in diet quality and greater preschool participation, enhancing both nutrition     and stimulation. However, there is limited evidence on the impacts of such programs, all of     it from Latin America. There is also no evidence on the relative impact of different transfer     modalities linked to preschool participation.      This study is a cluster-randomized controlled evaluation of a transfer program linked to     preschool participation. The transfer program, administered by the World Food Programme,     provides food or cash transfers to children aged 3-5 years enrolled in preschools at     baseline. The preschools, operating in the Karamoja sub-region of Uganda, are supported by     UNICEF and managed by District representatives of the Government of Uganda. The food     transfers consist of multiple-micronutrient-fortified corn soy blend (CSB), oil, and sugar,     totaling approximately 1200 calories per day per child and including 99% of iron     requirements. Cash transfers equal the estimated value of the food basket if purchased in the     market. Randomization into the food treatment, cash treatment or control was done across 98     preschools, referred to as Early Childhood Development (ECD) centers. The intervention period     was from February 2011 to May 2012 and included distribution of transfers on a     six-to-eight-week cycle. A longitudinal (panel) survey of households with children aged 3-5     years at baseline was conducted before exposure to the transfers and 18 months later. The     randomized design of this effectiveness study and the panel nature of the data allow for a     rigorous field trial in which impacts on nutrition and cognitive outcomes can be assessed and     compared across modalities.      We examine the impacts of the two transfer modalities, cash transfers or     multiple-micronutrient-fortified food transfers, linked to preschool enrollment, on child     nutrition and cognitive development. In addition, we explore potential mechanisms through     intermediate impacts on food intake and participation in preschools.      The key research objectives are to assess the following:        1. Impacts on targeted groups: Assess the effects of cash or food transfers on nutrition          and cognitive outcomes in children aged 3-5 years at baseline and explore pathways for          these effects.        2. Optimal program design: Assess the differential impacts of a program in which children          are provided multiple-micronutrient-fortified food transfers linked to preschool          enrollment compared with one in which they are given the equivalent value of cash          transfers linked to preschool enrollment.   "
116309|NCT01763489|"     Background: The ASSIST tool is a graphical tool to represent and evaluate the applicability     of a surgery trial to improve the translation of research to practice.      Objective: To evaluate the impact of the ASSIST tool on the interpretation of the     applicability of randomized controlled trials (RCTs) in the field of digestive cancer     surgery.      Design: This study is a randomized controlled trial with two parallel arms. Participants:     Surgeons who contribute to the assessment of manuscripts as experts (peer-reviewer) for     international scientific journals of surgery (Annals of Surgery, Archives of Surgery,     Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology).      Intervention: Surgeons will be randomized into 2 groups. A group that will evaluate a case     vignette (synopsis) of a randomized trial in surgery, and the other group that will evaluate     the same case vignette with the representation of the external validity of the trial with     ASSIST tool.      Outcome measures: Participants will indicate on a numeric scale range from 1 to 10 if they     feel able to judge the applicability of the trial for 1) patients, 2) centers, 3) surgeons     and 4) intervention.      Sample Size: 28 case vignettes with randomized trials and their ASSIST tool have been     developed and evaluated. The inclusion of 130 participants (65 per arm) is required.   "
116310|NCT01763476|"     There is both a poor life expectancy and a poor prognosis of limb salvage in those patience     with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number     of these patients could be helped through medication or surgery. In fact within the first     year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90%     have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA     for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases     3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year     primary patency rates up to 30%.      The primary objective of this study is to compare the performance of atherectomy followed by     a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo     infrapopliteal lesions in a prospective, single-center, randomized clinical trial.   "
116311|NCT01763463|"     Pneumonia remains an important cause of morbidity and mortality in older adults with     obstructive lung disease. Risk factors for pneumonia, including episodes associated with a     hospital admission, have been extensively characterized in clinical trials and observational     studies of patients with COPD, and include older age, lower predicted FEV1 (<50%), prior COPD     exacerbations, dyspnea , normal to low body mass index (<25), current smoking and certain     co-morbid conditions (e.g. dementia). The use of inhaled corticosteroids (ICS) has also been     identified, as associated with an increased risk of pneumonia in patients with COPD.      The primary objective of this study is to estimate the magnitude of known risk factors and     the outcomes of pneumonia requiring hospitalization and the potential effect modification of     these risk factors by ICS use. The primary endpoints will be severe pneumonia, defined as     community-acquired pneumonia (CAP) resulting in hospitalization and/or death and     hospital-acquired pneumonia (HAP) diagnosed after two days in the hospital. As a secondary     endpoint, CAP that did not result in hospitalization or death will be examined. As a     secondary objective, we will describe characteristics for those patients who develop     pneumonia requiring hospitalization compared to those with pneumonia not requiring admission.      This study will use the General Practice Online Database (GOLD), formerly referred to as the     General Practice research Database (GPRD), a primary care electronic medical record database.      A new user cohort will be defined among patients with COPD who are 45 years and older in the     United Kingdom. Patients will be considered a new user of ICS-containing medications if they     had not received a prescription for an ICS-containing medication in the prior year. The     comparator treatment group will be new users of long-acting bronchodilators (LABD), including     long-acting beta-agonists (LABA) or long-acting antimuscarinics (LAMA). In the one year     washout period, all new users could not have either ICS-containing medications or LABD.      Prior to conducting the analysis, feasibility analyses will be conducted to evaluate of the     number of pneumonia events and the number of new users separately to examine the available     precision based on the study design.      Patients will be followed from the date of their first eligible prescription (Cohort Entry     Date) until the earliest of the following: date of study end point (first pneumonia event of     interest), date of treatment end (up to 60-day gap allowed for each inhaler), date of     transfer to a new practice, date of ICS initiation (among LABD new users), death or study end     (end of available data). As part of the primary analysis, patients will be examined for their     first severe pneumonia (severe CAP, HAP). As a secondary analysis, time to non-severe CAP     will be examined. Incidence rates of the pneumonia outcomes will be calculated as the number     of patients experiencing an event divided by the person-years at risk.      Multivariable analysis will be performed using Cox proportional hazard model with adjustment     for confounders and medication exposure. To adjust for differences confounding by severity     due to differences in prescribing between ICS-containing medications and LABD, propensity     scores (PS) will be utilized using inverse probability of treatment weighting (IPTW). The     propensity score will be estimated to model the probability of a patient receiving     ICS-containing medication prescription versus receiving a LABD prescription given a patient's     observed set of baseline covariates.      Effect modification (statistical interaction) will be evaluated based on available theory and     include ICS medication use by known risk factors for pneumonia (BMI<21, BMI 21-24.9, BMI ≥25,     age, GOLD stage III/IV, MRC dyspnea score ≥4, history of pneumonia diagnosis, current smoking     status, social deprivation quartiles). Additional interactions may be evaluated.      To test proportionality of the hazard functions, model diagnostics will be performed.      To compare severe pneumonia with non-severe pneumonia in patients with COPD, characteristics     of patients experiencing non-severe CAP vs. severe CAP or HAP will be tabulated. To assess     differences between treatments, clinical and patient characteristics will be compared using     the chi-square tests or Wilcoxon tests for categorical or continuous data, respectively.     Severe CAP and HAP may be combined. Modeling of clinical and patient characteristics may be     considered using logistic regression using CAP vs. severe CAP and then with severe CAP vs.     HAP.      Additional analysis or adjustments to the analytic or modeling strategy will be performed if     the data warrants. A more detailed modeling strategy, including generation of the propensity     scores and Cox modeling, will be created in a separate analysis plan. Adjustments to the a     priori plan will be described in the final study report.   "
116312|NCT01763450|"     A multi-center, non-random, open study ,to observe efficacy and safety of bevacizumab plus     Oxaliplatin based multidrug chemotherapy as conversion therapy for patients with previously     untreated unresectable liver metastases from colorectal cancer.   "
116313|NCT01763437|"     The investigators propose a study to investigate the role of tetracycline injection into     chalazia versus observation alone. The investigators hypothesize tetracycline injection will     result in a significant decrease in lesion size when compared to observation alone.   "
116314|NCT01763424|"     This study will determine if combination of topical calcipotriol and nicotinamide is more     effective than calcipotriol alone in treatment of psoriasis.   "
116315|NCT01763411|"     This retrospective study comprised patients with cataract, corneal astigmatism, and     motivation for spectacle independence. In all cases, a multifocal and monofocal Intraocular     Lens was been implanted in the capsular bag. Three months postoperatively, distance,     intermediate, and near visual acuities; spherical equivalent; residual refractive     astigmatism; defocus curve; and contrast sensitivity was evaluated. A patient-satisfaction     and visual phenomena questionnaire was also been administered.   "
116316|NCT01763398|"     The domestic standards of G-CSF permit the use of the G-CSF only when the ANC(absolute     neutrophil count) drops to 1,000/uL or below. Therefore it is impossible to inject the G-CSF     in order to prevent neutropenia. However, 'the 2006 Update of Recommendations for the Use of     White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline(J ClinOncol     2006; 24:3187-3205)' and the 'NCCN Guideline' have revealed that as a precaution, it is     appropriate to inject the G-CSF to the non-Hodgkin's lymphoma patients with high-risk factors     under the anticancer treatment of CHOP-21 Rituximab before the number of neutrophils     decreases. Thus, it is intended to analyze the risk factors of febrile neutropenia in a     high-risk group of non-Hodgkin's lymphoma patients with a neutropenic fever who receive the     CHOP-like regimen and primary G-CSF prophylactic therapy every three weeks. (The definition     of neutropenic fever is a fever over 38.3 degrees C or continuous fever lasting longer than 1     hour over 38 degrees C with the number of neutrophil ≤ 500/uL or neutrophil ≤ 1,000/uL in     case of expected decline to ≤ 500/uL within 48 hours.)   "
116317|NCT01763385|"     This project is aim to explore non-increased-intracranial-pressure symptomatic brain     metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with     Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are     treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and     continued to take Erlotinib till extracranial lesions progression. Control group are     Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after     radiotherapy until recurrence or termination for other reasons.   "
116318|NCT01763372|"     The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas     release. To complete this aim, we will recruit patients who have undergone arthroscopic     iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as     their own control. To delineate the effects of arthroscopic surgery alone from those     resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a     second control group consisting of patients who have undergone arthroscopic surgery by Dr.     Aoki without iliopsoas release.      For both hips of each subject, we will:        -  Quantify the muscle volume of the iliopsoas muscle with MRI.        -  Quantify hip flexion strength with isokinetic dynamometry.        -  Quantify patient function and satisfaction with functional outcome surveys.      This data will allow us to test the following hypotheses:        -  Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have          decreased iliopsoas muscle volume and hip flexion strength.        -  Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips          undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip          flexion strength.        -  Patient function and satisfaction positively correlates to muscle bulk and strength.   "
116319|NCT01763359|"     The purpose of this prospective study is to compare hip adductor strength and obturator nerve     palsy between acetabular fracture patients whose fracture was reduced and fixated using the     modified Stoppa approach (subjects) and pelvic fracture patients (controls) using physical     strength testing, radiographs, clinical assessment, and a validated functional outcome     questionnaire. The investigators' research hypothesis is that there will be less strength and     higher incidence of obturator nerve palsy in patients treated with the modified Stoppa     approach (intervention) than in patients treated without the modified Stoppa approach     (controls).   "
116320|NCT01763346|"     Weight loss achieved through gastric banding will be superior to treatment with metformin in     preserving or restoring pancreatic beta cell function in people with prediabetes or mild type     2 diabetes.   "
116321|NCT01763333|"     To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of     BI 1026706   "
116322|NCT01763320|"     Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent     stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment,     however, the results of this trial, its inclusion criteria and its center selection received     significant criticism and did not appear to reflect our experience, neither regarding natural     history, nor treatment complications rate. As ICAS is the most common cause for stroke in     Asian countries, we are hereby proposing a refined prospective randomized multicenter study     in an Asian population with strictly defined patient and participating center inclusion     criteria.      The China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS)     trial, is an ongoing, government-funded, prospective, multicenter randomized trial. It     recruits patients with recent TIA or stroke caused by 70-99% stenosis of a major intracranial     artery. Patients with previous stroke related to perforator ischemia will not be included.     Only high-volume center with a proven track record will enroll patients as determined by a     lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical     therapy plus stenting. Primary endpoints are any stroke or death within 30 days after     enrollment or after any revascularization procedure of the qualifying lesion during     follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days     The CASSISS trial will be conducted in 8 sites in China with core imaging lab review at a     North American site and aims to have a sample size of 380 subjects (stenting, 190; medical     therapy, 190). Recruitment is expected to be finished by Dec, 2016. Patients will be followed     for at least three years. The trial is scheduled to complete in 2019. In the proposed trial,     certain shortcomings of SAMMPRIS including patient and participating center selection will be     addressed. The present manuscript outlines the rationale and design of the study. We estimate     that this trial will allow for a critical reappraisal of the role of intracranial stenting     for selected patients in high volume centers.   "
116323|NCT01763307|"     Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic     colorectal cancer patients.      This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat     with reconval cream half face versus placebo cream half face to study whether Vitamin k1     cream can prevent the typical skin eruption caused by EGFRI.   "
116324|NCT01763294|"     There is a continuous necessity for the search of new alternatives for safe, affordable and     effective noninvasive therapies for patients that are not eligible for focal resective or     palliative surgery. The transcranial direct current stimulation (tDCS) therapy has     demonstrated to be safe, noninvasive, simple and effective with promising results in case     series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a     feasible and low cost method to modify cortical excitability in a non-invasive procedure. Its     effects on cortical excitability seem to be similar to the effects induced by repetitive     transcranial magnetic stimulation. The aim of this study is determine the safety and efficacy     in the reduction of the number of seizures (>50%) and epileptiform activity in patients with     refractory and multifocal epilepsy after different protocols of tDCS compared with placebo.   "
116325|NCT01763281|"     The investigators have been developing new, non-invasive magnetic resonance imaging (MRI)     techniques to image the small bowel. Building on those studies the investigators want to     study, in healthy volunteers, the effects of stress on the water content of the small bowel     following ingestion of fructose. This is important because in Irritable Bowel Syndrome (IBS),     there seems to be a strong association of stress and anxiety with the severity of the     disease. Many IBS patients complain of food intolerances and recent studies have suggested     that food with high content of fructose can worsen symptoms of IBS. The investigators will     carry out a study in which the investigators will induce a moderate state of stress in     healthy volunteers using an injection of corticotrophin release hormone, feed them a drink     containing fructose and image their bowel at intervals using MRI. Improving our understanding     of the effects of stress and fructose on small bowel physiology will help us to understand     better some aspects of the symptoms such as bloating, altered bowel habit and abdominal     discomfort, experienced by the IBS patients and to guide therapy. The investigators     hypothesize that the effect of CRH will cause significant decrease in small bowel water     content (SBWC) and a faster small bowel transit with increased malabsorption following     consumption of fructose.   "
116349|NCT01762969|"     The investigators will check the feasibility of using early molecular response for making     treatment decisions. Patients diagnosed with chronic myeloid leukemia will commence imatinib     treatment. After 3 months of treatment their response will be assessed. If molecular response     would be less the 10% (BCR-ABL1/ABL ISI >10%)imatinib therapy will be stopped and patients     will start a different TKI (as nilotinib, dasatinib). The investigators will follow on lab     and clinical outcomes.   "
123944|NCT01663454|"     The purpose of this pilot study is to assist the preparation of a larger multi-center study.     The main aim is to determine the feasibility of conducting computerized working memory     training in a group of children with cerebral palsy.   "
116326|NCT01763268|"     Open-label, single-arm trial, Primary Objectives included:        1. To assess the immunogenicity of TrivivacTM administered in healthy infants aged between          9-14 months.        2. To assess the safety (reactogenicity) of TrivivacTM administered in healthy infants aged          between 9-14 months.      The study will be done on healthy infants, 9-14 months of age. After enrolment, the infants     will be given one dose of primary vaccination MMR (TrivivacTM),SEVAPHARMA BiogenetechLtd.     study vaccines will be administered subcutaneously into the anterolateral aspect of right     thigh.outer aspect of the upper arm. Subjects will be followed at approximately 6 weeks after     primary vaccination to evaluate response to primary immunization of this vaccine. Blood     sample will be collected from subjects at visit 1 (prior to immunization) and visit 2 (6     weeksone month after completion of this first dose of immunization). The serum samples will     be analysed for Anti-measles, Anti-mumps and Anti-rubella antibodies. Proportion of subjects     achieving seroprotection and geometric mean titers of antibody against measles, mumps,     rubella at 6 weeks after one dose vaccination of MMR vaccine at aged 9-14 months will be     evaluated. Adverse reactions will be observed on each vaccination day (up to 30 minutes) and     for 4 days (Day 0-3) after each dose. Adverse reactions will also be monitored for 30 days     following each vaccination. Serious adverse events will be monitored for the entire study     duration.   "
116327|NCT01763255|"     Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can     involve brain and nervous system functions such as movement, learning, hearing, seeing, and     thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these     problems occur as the baby grows in the womb, but they can happen at any time during the     first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem     cells are known as a effective therapy.      In this study the investigators evaluate the side effect of multiple intrathecal injection of     bone marrow stem cell in patients with cerebral palsy.   "
116328|NCT01763242|"     Aims:        1. To establish an electronic process for CKD anaemia management using monthly synchronized          dosing of erythrocyte stimulating agents (ESA).        2. To compare this electronic process with present anaemia management in the traditional          outpatient setting.        3. To monitor Hb targets and clinical endpoints of study groups to model a larger          multicentre study focusing on these endpoints.   "
116329|NCT01763229|"     To test if transthoracic echocardiography is useful for correct positioning of central venous     catheters in infants with congenital heart disease   "
116330|NCT01763216|"     Late-life depression levels are escalating, and include 24% of all tenants of Assisted Living     (AL) settings. A promising, novel intervention is a computerized visual speed of processing     training program known as Road Tour. Road Tour has been show to reduce depressive symptom     levels and the risk of onset of clinical depression in community dwelling older adults. The     investigators hypothesize that similar benefits will accrue to residents in AL settings.      To evaluate this the investigators will use a two-arm, parallel, randomized controlled trial     (RCT) comparing Road Tour training to attention control using computerized crossword puzzles     among 370 adults 55 years old or older who reside in 15-30 AL settings that are partnering     with the investigators.      The investigators hypothesize that Road Tour participants will have improved cognitive     processing speed, lower levels of depressive symptoms, lower likelihood of the onset of     clinical depression, less anxiety, lower levels of pain symptoms, and better health-related     quality of life. These outcomes will be assessed at baseline, post-training, six months, and     one year.   "
116331|NCT01763203|"     The purpose of this study is to test a newly-developed outpatient clinic and community-based     care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and     Chronic care model teams Early to End Disparities) for improving control of stroke risk     factors among stroke patients in the Los Angeles County safety net, and to measure the     costs of running such an intervention, relative to usual care.   "
116332|NCT01763190|"     Primary Objective:      To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of     SAR302503.      Secondary Objective:      To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild,     moderate and severe renal impairment and in matched subjects with normal renal function.   "
116333|NCT01763177|"     Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat     (POST). Oxygen nebulizer therapy increases humidity to the airway, especially     post-extubation.      Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.   "
116334|NCT01763164|"     Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the     efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in     patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61     mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be     performed at a central laboratory. Only those patients with Q61 mutation per central     laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will     be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified     according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0     versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This     study will use an Interactive Response Technology (IRT). The primary end point of the study     is progression-free survival. Key secondary end point is overall survival   "
116368|NCT01762722|"     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the     brain. It is similar to the device that measures the level of oxygen in the tip of the     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the     forehead that both emits and detects the amount of light absorbed. This study will determine     how accurate the device is by comparing the displayed value on the monitor with blood samples     taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In     order to test the device over a suitable range, the level of oxygen within the blood will be     reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the     equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy     volunteers.   "
117125|NCT01752842|"     This study will test whether lowering the delivery of excess fats to the heart in persons     with type-2 diabetes mellitus improves heart muscle function. The investigators will also     test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic     heart disease.   "
116335|NCT01763151|"     With increasing demands of patients concerning refractive outcome after cataract surgery,     toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more     widely to cataract surgery. Originally toric IOLs were used mainly for patients with high     degrees of astigmatism, especially after corneal surgical procedures such as penetrating     keratoplasty. Since a couple of years, toric IOLs are available from numerous manufacturers     to correct lower amounts of astigmatism which are much more prevalent with about 30% having a     corneal astigmatism of 0.75D or more in the cataract population. This should result in less     spectacle dependence of patients due to the astigmatic correction.      The alternative method to reduce corneal astigmatism as part of cataract surgery is to make     incisions on the steeper axis of the cornea such as limbal relaxing incisions or an     additional clear corneal incision opposite (OCCI) to the main cataract opening. These     techniques are in use since more than 2 decades and are widely used in clinical routine. As     with toric IOLs, precise alignment of the cuts with the axis of astigmatism is essential. The     disadvantage of the incisional techniques is the variability of the effect between patients     since it depends on factors such as the extent of scaring of the cuts after surgery as well     as corneal thickness. The main advantage is the simplicity of the technique and the lower     cost.      Aim of this study is to compare toric IOL implantation and opposite clear corneal incision     during cataract surgery to correct corneal astigmatism.   "
116336|NCT01763138|"     The purpose of this study is to determine the effect of an educational intervention on     mothers knowledge, attitudes and practices for preventing childhood caries.   "
116337|NCT01763125|"     Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy     people as controls. The blood samples will be collected systematically together with the     corresponding clinical data. The biological samples, the clinical date together with     prospective experimental date constitute the entity of the tumor bank.   "
116338|NCT01763112|"     Title of study / project: Influence of training with whole body vibration device on Quality     of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle     function in patients with pulmonal arterial hypertension (PAH). Background and rationale for     the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is     a few investigations evaluating the effects of the training with whole body vibration (wbv)     in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and     had positive effects on the neuromuscular system. Primary scientific question     addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in     QoL are to be evaluated.   "
116339|NCT01763099|"     The purpose of this study is to evaluate the utility of treating patients experiencing graft     failure after autologous hematopoietic stem cell transplantation with ex-vivo-expanded     BM-drived mesenchymal stem cells from third-party donors or mesenchymal stem cells combined     with cord blood. The first objective of this study was to evaluate the effect of such     treatment on graft failure, and second object was to investigate the safety of such     treatment.   "
116340|NCT01763086|"     The purpose of this study is to evaluate the utility of treating patients experiencing poor     graft function after allogeneic hematopoietic stem cell transplantation with ex-vivo-expanded     BM-drived mesenchymal stem cells from third-party donors. Our first objective was to evaluate     the effect of such treatment on poor graft function, and second object was to investigate the     safety of such treatment.   "
116341|NCT01763073|"     The objective of this study is to ascertain factors shaping medical students' pre-residency     intention to provide abortion through an in-depth qualitative investigation into the context     and experiences that shape intention to provide.   "
116342|NCT01763060|"     Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or     circulatory failure show severe long term disability due to impaired lung -, cerebral-,     cognitive function and impaired quality of life. This study investigates the long term     outcome of all patients who are still alive three years after ECMO treatment for severe     respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.   "
116343|NCT01763047|"     The objective of this study is to evaluate the performance of a novel multifocal lens system.   "
116344|NCT01763034|"     Contrast media induced nephropathy (CIN) is considered to be a serious complication in     patient who underwent coronary angiogram (CAG). The pathogenesis of CIN does not well     understood. The probable one is the contrast media makes the afferent vessel in glomeruli     constrict and results in renal shut down. Limb ischemic preconditioning, a procedure that     makes muscles become ischemic and adapt themselves to produce some cytokines for signaling     the vessel more dilated. After the reperfusion, these cytokines are getting back to systemic     circulation and effect the afferent vessel in glomeruli to become more dilated and prevent     CIN.   "
116345|NCT01763021|"     The purpose of this study is to assess the potential effects of rifampin on the     pharmacokinetics (how the drug concentrations change over time) of PCI-32765 in healthy     participants.   "
116346|NCT01763008|"     The purpose of this study is to assess the safety and effectiveness of doripenem treatment     among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections,     and complicated urinary tract infection.   "
116347|NCT01762995|"     Human immune virus (HIV) infected subjects may take mineral supplements in combination with     their antiretroviral medications. Calcium and Iron supplementations are commonly used and     both of these have the potential to interact with Dolutegravir (DTG), this study will     evaluate the potential of calcium and iron supplements to decrease DTG exposure. It will also     evaluate two possible strategies for combined use; if an interaction is observed. The first     strategy is a two hour separation. The second strategy involves the administration of DTG and     the supplement with a meal since the presence of food modestly increases DTG exposure, and     because mineral supplements can be administered with food.      This is an open label, randomized, two cohort, four-period cross-over study in healthy     volunteers. One cohort will examine the effects of calcium carbonate and the other cohort     will examine the effects of ferrous fumarate on the pharmacokinetic (PK) of DTG.     Approximately 12 subjects will be enrolled into each of the two cohorts and receive each of     four treatments in a randomized fashion: 1) A single dose of DTG 50 milligram (mg)     administered under fasted conditions ; 2) A single dose of DTG 50 mg co-administered with a     single dose of calcium carbonate or ferrous fumarate under fasted conditions ; 3) A single     dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous fumarate     with a moderate-fat meal; 4) A single dose of DTG 50 mg administered under fasted conditions     2 hours prior to administration of a single dose of calcium carbonate or ferrous fumarate.     There will be a washout period of at least 7 days between treatments. Safety evaluations and     serial PK samples will be collected during each treatment period. A follow-up visit will     occur 7-14 days after the last dose of study drug. This study will be conducted at one center     in the United States, with healthy adult male and female subjects.   "
116348|NCT01762982|"     The aim of the study is to evaluate the irritation potential of benzalkonium chloride     disinfectant spray when placed in contact with normal human skin.   "
116350|NCT01762956|"     The pelvic floor disorders are a major problem in our current society with manifestations of     micturition disorders, defecatory problems and sexual dysfunction. The pelvic floor muscles     training arouses interest due the few studies on this subject. Studies are being conducted     with emphasis on the post-prostatectomy urinary disorders, however, not associated with     radiotherapy. The study of the effect of radiotherapy in these muscles is still uncertain. At     right, we do not know if the effect of radiation can trigger important anatomical changes     that could lead to pelvic floor disorders manifesting clinically as defecatory and urinary     disorders. These issues motivate us to research, focusing on the evaluation of these muscles     through magnetic nuclear resonance considering that radiation therapy has been increasingly     used as a therapeutic option in the treatment of prostate cancer. The primary objective of     this is to verify the effect of pelvic floor muscles training (PFMT) tract symptoms (LUTS),     anorectal and sexual complaints in men with prostate cancer (PCa) treated with radiotherapy     (RT). Secondly, the objective is to evaluate the effect of PFMT in its function and in the     severity of urinary incontinence (UI) and evaluate the quality of life. The assessment of the     changes occurred by the effect of radiation separately and jointly to the training of the     pelvic floor muscles can help us to better understand some of the dysfunctions presented in     this sample of patients as well as understanding the effect and the possible contribution of     training of these muscles for treatment and/or prevention of these disorders.   "
116351|NCT01762943|"     Understanding the neural and biological mechanisms by which reproductive hormones influence     mood is critically important for public health given that postpartum depression is the     leading cause of morbidity and mortality associated with childbirth and has negative effects     on infants. Using a hormone-withdrawal challenge to precipitate mood symptoms will improve     our ability to identify the biological mechanisms underlying both the triggering of and     susceptibility to depressive disorders in women; and will permit the prediction of those at     risk for PPD and other reproductive-related mood disorders.   "
116352|NCT01762930|"     Background:      Cholera is a public health problem globally and in Bangladesh and its prevention is     important. Despite recent availability of an effective and affordable oral cholera vaccine     (OCV), its field application remains a challenge and needs to be addressed in carefully     conducted research studies.There is lack of information on temperature sensitivity and     resulting immunogenicity of Shanchol OCV and it is not known if administration of two doses     of OCVs, one month apart, instead of currently recommended 14 days, to improve success of     vaccination programme will be effective;also if one dose of the vaccine, instead of currently     recommended two doses, would result in adequate immune response in population exposed to V.     cholerae in an endemic country like Bangladesh.      Objectives:      To determine immunogenicity of Shanchol in adults. when:        1. the vaccine is stored at three defined temperatures(25 oC ,37 oC and 42oC) for 14 days,          before putting back in cold box for administration in the field and compare them with          the response when the vaccine is stored under currently recommended temperatures.        2. two doses of the vaccine administered one month apart and compared vaccines administered          at currently recommended interval of 14 days.        3. a single dose is administered and compare them with responses after recommended two          doses.      Methods: The study will be conducted among adults living in the Mirpur community in urban     Dhaka, the capital of Bangladesh.Studying safety and acute and long-term immune responses     over a period of one year.      Outcome measures/variables:        1. Objective 1: safety and immunogenicity of vaccine in adults after its storage at three          defined temperatures (25oC ,37oC and 42oC) by measuring vibriocidal antibody responses          and compare them with the findings when the vaccine is stored at currently recommended          temperature of 2-8oC (recommended by manufacturer, Shantha Biotechnic).        2. Objective 2: compare vibriocidal responses following administration of two doses of the          vaccine one month apart and compare them with vaccination 14 days apart over a period of          one year, with study of the memory responses over a one year period as a secondary          outcome.        3. Objective 3: compare acute immune responses (vibriocidal antibody) following one and two          doses of vaccine, and compare memory response as a secondary outcome measure, over a one          year period.      The above information is needed urgently for developing effective vaccination strategies for     prevention and control of cholera in endemic countries.   "
116353|NCT01762917|"     Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results     in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag)     is proposed by the system, however, elderly patients or those suffering from high grade     pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to     completely mix the test gases. The aim of our study is to evaluate the effect of adapting     Vbag on the reproducibility of IGR measurements in patients with obstruction (group A),     restriction (group B) and pulmonary healthy controls (group C).   "
116354|NCT01762904|"     Currently there are few options for skin antisepsis, commercially antiseptic triclosan is     mainly used. To have more options, this study is necessary, where investigators will     determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan     in 70% isopropyl alcohol and choose the one with the best characteristics for skin     antisepsis.   "
116355|NCT01762891|"     Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin are     advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of bleeding.     New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating pain and     inflamation in these patients once interactions with coumadin are supposed to be lower. The     CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI with new     cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen and     placebo.   "
116356|NCT01762878|"     GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta     (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of     inflammatory airway diseases. GSK2269557 has already been administered as a nebulized     solution in single and repeat doses to humans and has been well tolerated across the range of     doses used. The purpose of this study is to evaluate the safety, tolerability and     pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This study     is the first administration of dry powder GSK2269557 in humans.      Part A will consist of four treatment periods separated by at least 14 days wash out periods.     In each treatment period there will be 12 subjects receiving GSK2269557 and 4 subjects     receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms (mcg), 500     mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be reviewed     before each dose escalation. Part B will be a parallel group design conducted in a separate     group of subjects from Part A. Nine subjects will receive repeat doses of GSK2269557 and 3     subjects will receive repeat doses of placebo for 14 days. The total daily dose will be the     same as the dose that was well tolerated in Part A. The study duration, including screening     and follow-up, is not expected to exceed 82 days for subjects in part A and 55 days for     subjects in part B of the study.   "
116357|NCT01762865|"     The investigators hypothesized that acute bronchitis will be associated with various bacteria     and viruses.   "
116371|NCT01762683|"     The purpose of this study is to improve the understanding of cellular mecanism involved in     delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of     myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of     blood mononuclear cells, of leptine and of obese women sera to interfere with the transition     of myometrial cells toward hyperplasia phenotype.   "
116358|NCT01762852|"     The main clinical study will be a randomized, double-blind, placebo-controlled, long term     study involving a 100 week treatment period. The purpose of this study is to test for     superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo     plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study     is also to investigate the effect of initiating earlier treatment with belimumab compared to     delayed treatment with current immunosuppressive treatment regimens. The study will also     determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of     action of Belimumab as well as effects on quality of life. All subjects (on either active     treatment or placebo) will receive background supportive therapy throughout the main clinical     study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin     receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary     salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening     will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total     of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive     intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on     Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a     total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted     to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio     (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of     belimumab in the urine. Subjects who are withdrawn from study treatment at any time during     the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to     week 104. A subject will be regarded as having completed the main clinical study if they     complete all phases of the main clinical study (screening, treatment period, 4 week and 16     week post last dose short term safety follow-up). Subjects who complete the main clinical     study will therefore participate in the main clinical study for approximately 28 months.     After the main clinical study, there will be a 5 year (long term) follow-up phase to assess     long term outcomes.   "
116359|NCT01762839|"     The purpose of the study is to generate cardiac safety data using a supratherapeutic     oritavancin dose of 1600 mg.   "
116360|NCT01762826|"     Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in     non-obese pregnant women at high risk for gestational diabetes mellitus.   "
116361|NCT01762813|"     -  A prospective, observational study on clinical outcomes of surgical management of          primary and metastatic colorectal cancer        -  Prospective collection of tissues to explore potential biomarkers in blood and/or          primary or secondary cancers and/or normal colon   "
116362|NCT01762800|"     The purpose of this study is to assess the control of COPD using a symptom and exacerbation     risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese     subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice     in Japan.   "
116363|NCT01762787|"     The purpose of this study is to refine the cantharidin-induced blister assay in healthy     volunteers as a model of inflammatory disease. The study is an experimental trial in healthy     volunteers in two parts; Part 1 to optimise the model and Part 2 to validate using two     anti-inflammatory treatments with different modes of action.   "
116364|NCT01762774|"     This study is the First Time in Human Study for GSK2256294 and will evaluate the safety,     tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses     of GSK2256294 administered to healthy male volunteers (Cohort 1) and otherwise healthy adult     male moderately obese smokers (Cohorts 2 to 4). Cohorts 1 and 2 will enrol 12 subjects each     and each subject will take part in four study periods. All subjects will receive placebo     regimen and three dosing regimens of GSK2256294 in a specified sequence (planned doses 2 mg,     6 mg and 18 mg in Cohort 1 and 15 mg, 40 mg and 100 mg in Cohort 2). Each study period will     be followed by a Wash-out period of 7 to 14 days in Cohort 1 and up to 4 weeks in Cohort 2.     During each study period subjects will be in-house from Day -1 until the 48 hours post dose     assessments have been completed. Subjects will return to the unit as out-patients for     remaining post-dose assessments. Subjects will then be followed for 7 to 14 days in Cohort 1     and up to 3 to 4 weeks in Cohort 2. Total duration of the study for Cohort 1 will be 98 days     and for Cohort 2 it will be up to 144 days. Cohort 3 and 4 will each recruit 15 subjects. For     Cohorts 3 and 4, each subject will take part in one treatment period of 18 days (Day-1 to Day     17) with dosing from Day 1 to Day 14. Subjects will then be followed for 7 to 14 days. Total     duration of the study for Cohort 3 and Cohort 4 will be 67 days. Dose selection for Cohorts 3     and 4 will be based on the safety, PK profile and enzyme inhibition obtained in Cohorts 1 and     2. This study will also evaluate the evidence for a functional effect of soluble Epoxide     Hydrolase (sEH) in a forearm blood flow (FBF) model.   "
116365|NCT01762761|"     This randomized, double-blind and open-label phase III study is aimed to determine the     efficacy, tolerance and safety of eltrombopag in Chinese chronic primary immune     thrombocytopenia (ITP) adult subjects. This study will be conducted in Chinese adult chronic     ITP subjects who have not responded to or have relapsed after previous treatment for ITP,     including first line therapy and /or splenectomy.      The primary objective of this study is to determine the efficacy of oral eltrombopag as a     thrombopoietic agent treating previously treated chronic Chinese ITP patients comparing with     placebo. The secondary objective is to assess the safety and tolerability of eltrombopag when     administered for 6 weeks to previously treated adult chronic ITP patients comparing with the     placebo. In addition, the long-term efficacy and safety of eltrombopag treatment will be also     evaluated in the 24-week extension open-label phase after the double-blind phase as one of     other study objectives. If the subject benefits from the eltrombopag treatment based on     investigator's discretion, the subject can continue eltrombopag treatment until the     commercial launch of eltrombopag in China. Furthermore, to understand the pharmacokinetics     (PK) profile of eltrombopag and to explore the relationship between the PK and     pharmacodynamics (PD) (platelet response), a PK/PD analysis will be embedded in this phase     III study and conducted in the same patient population participated this phase III study.   "
116366|NCT01762748|"     The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in     the waiting list for liver transplant.   "
116367|NCT01762735|"     Water injection colonoscopy has been a generally accepted method in training the beginners of     colonoscopy for its low pain and less cecal intubation time, we would conduct this study to     investigate more advantages of this method and make most use of it for beginners' training.   "
116372|NCT01762670|"     GoldenCare is a copper intravaginal device that may be useful for the treatment of     symptomatic bacterial Vaginosis (BV). Standard treatment for BV is metronidazole. Although     the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The     study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect     preliminary evidence of the safety and efficacy of GoldenCare.   "
116373|NCT01762657|"     The purpose of this study is to determine if oral Cyclosporine A and oral Lansoprazole are     effective in rendering patients with existing type 1 diabetes, insulin independent. This     two-arm study was designed to evaluate the safety and efficacy for insulin independence by     utilizing the FDA-approved oral immune tolerance agent, Cyclosporine A, and the FDA-approved     proton-pump inhibitor, Lansoprazole. Lansoprazole and other proton-pump inhibitors increase     gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell     formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).      Studies with the immune tolerance agent, Cyclosporine A, previously demonstrated that among     recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as     67.5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med.     1988:17;318(11):663-70). Cyclosporine A protected the remaining beta cells from further     autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was     ultimately required by all patients. Therefore, this study proposes the usage of Cyclosporine     A with a beta regeneration agent.      Follow-up studies for up to 13 years among 285 type 1 patients utilizing Cyclosporine A for     20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab     Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor     demonstrated reductions in daily insulin requirements by much as 75% within 3 months     following four weeks of therapy among existing type 1 diabetes patients (Transition     Therapeutics, March 5, 2007 http://www.transitiontherapeutics.com/media/archive.php Accessed     January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing     autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to     induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth     factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).      Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune     tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been     successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci.     2007;1103:19-32). The distinctions and complexities of islets in man are far different than     that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27:1-36 Epub ahead of     print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration     agent are required to sustain insulin independence.      Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to     10-fold, this clinical trial utilizes the oral proton-pump inhibitor, Lansoprazole. This     study will determine the safety and efficacy of Cyclosporine A used with and without     Lansoprazole to determine the impact on insulin independence among patients with existing     type 1 diabetes.      Cyclosporine A is utilized to protect the new beta cells formed by Lansoprazole. The     combination of the two therapies may render reductions in insulin requirements and have a     greater impact on sustained insulin independence than previously reported with Cyclosporine A     or gastrin alone among type 1 patients.A      This 52-week study consists of two treatment arms designed to assess the safety and efficacy     of achieving insulin independence using:        -  Oral Lansoprazole/Oral Cyclosporine A        -  Oral Placebo/Oral Placebo      It is hypothesized that the combination of oral Cyclosporine A and oral Lansoprazole will     safely render significantly more patients with existing type 1 diabetes, insulin independent     and may serve as a novel and innovative treatment approach for patients with type 1 diabetes     utilizing two FDA-approved therapies.   "
116374|NCT01762644|"     The purpose of this study is to determine if the combination of oral cyclosporine, an immune     therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin     independence among recent onset type 1 diabetes patients. This two-arm study is designed to     evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved     therapies among recent onset type 1 diabetes patients.      One of the greatest new insights of today in the field of type 1 diabetes, is the     understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is     no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now     considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan     2103).      More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some     studies have demonstrated as high as a 57% insulin-free remission rate that was not sustained     due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988, Eisenbarth 1989,     Sobel 2010). Studies among diabetes patients with proton pump inhibitors have shown the     potential to increase beta cell mass by 40%, but among type 1 patients without immune     protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014).      The usage of a beta cell regeneration agent such as omeprazole, in combination with an immune     tolerance, like cyclosporine, provides both the potential ability to maintain and regenerate     beta cells. This is a new paradigm for the treatment of new onset type 1 diabetes.      More than 60 human trials have been conducted among type 1 diabetes with a variety of     different therapies aimed at preventing autoimmune attack on insulin-producing beta cells.     None have been as effective as cyclosporine in both slowing the decline in beta cell mass and     resulting in the potential for insulin-free remissions. (Canadian-European Randomized Control     Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010).      Because cyclosporine is known for its potential side-effects, most notably in the kidney, all     previous studies among type 1 patients have carefully monitored kidney function. Follow-up     studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months did     not demonstrate renal or other side effects at the dosages that will be used in this trial     (Assan 2002).      The most effective initiating dosage for insulin independence in the cyclosporine trials was     7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and     will monitor kidney function and cyclosporine levels initially on a weekly basis. This study     will use only those dosages of cyclosporine that have not demonstrated toxicity to the kidney     or resulted in non-reversible side effects among more than 500 patients with recent onset     type 1 diabetes treated with cyclosporine.      Omeprazole has been shown to significantly increase gastrin levels which is associated with     increased beta cells. Lansoprazole has also been shown to be safe among patients with new     onset type 1 diabetes for one year with a trend toward increased beta cell mass among     patients with higher gastrin levels.      In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those     randomized to receive a proton pump inhibitor had significantly increased gastrin levels,     higher insulin levels and improved endocrine function by glucose tolerance testing and less     pancreatic atrophy as measured by CT scans (Jang 2003).      The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton     pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its     endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta cells     was specifically noted to have likely been due to lack of usage of immune therapy to protect     beta cells (Griffin 2014, Rigby 2014).      Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the     control group had a trend towards improved preservation of C-peptide with a suggestion of a     decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental     data). Glucose levels also trended lower than controls in the intervention arm with gastrin     levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly     forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006).     REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy     among type 1 patients (Griffin 2014, Rigby 2014).      The combination of cyclosporine with a proton pump inhibitor has the potential to demonstrate     maintenance and expansion of residual beta cells. This combination therapy provides the     unique ability for patients to become insulin independent.      For a request of references, please email info@perlebioscience.com   "
131698|NCT01561183|"     To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement     for management of human dental pulp with irreversible pulpitis.   "
116376|NCT01762618|"     A randomized controlled trial designed to test the effectiveness of a psychological     intervention based on group therapy for the caregivers of Alzheimer's disease patients. The     intervention consists of 14 sessions of a cognitive-behavioral psychological group therapy.     This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group     counseling, with an improvement in mood state, quality of life, perceived burden and a     decrease in anxiety and depression. Two evaluations will be done: before the therapy sessions     (basal) and when intervention is finished (final).   "
116377|NCT01762605|"     This study determines if patients with buckle fractures of the distal radius and/or ulna     treated with supportive care only demonstrate non-inferior outcomes in regard to pain control     during healing, functional outcome at the wrist joint, and parental satisfaction, when     compared with patients treated with the standard treatment regimen of 3-4 weeks in a short     arm cast.   "
116378|NCT01762592|"     Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine     (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate     cT1-renal masses.   "
116379|NCT01762579|"     The aim of the investigators' study is to evaluate biochemical, immunological and     histological characteristics of patients affected with the so-called gluten (or wheat)     sensitivity who suffers from irritable bowel syndrome (IBS)-like symptoms.      As it is not known what component of the cereals causes the symptoms in so called     gluten-sensitive patients, the investigators prefer to speak of not-celiac wheat     sensitivity (NCWS).      NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop     symptoms following wheat consumption, that improved on wheat/gluten free diet (GFD). For our     research, we will select adult patients, both genders, affected with suspected NCWS (i.e.     with symptoms/signs which disappeared on GFD and worsen on a gluten containing diet, testing     negative for celiac disease [anti-tissue transglutaminase antibodies, anti-tTG, and     anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1] and wheat allergy [serum specific     IgE for wheat]). The patients will be recruited at the Department of Internal Medicine,     'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of the     University of Palermo, from January 2012 to October 2013, for IBS-like symptoms.      At the time of the recruitment, the patients will be on GFD by at least one month and must be     asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg and     other foods) could be prescribed in patients who are suspected to suffer from multiple food     hypersensitivity. The patients will be randomized to undergo a double-blind     placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days.     Before and after the challenge, the investigators will evaluate gastrointestinal     (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood     sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and     rectoscopy, with multiple biopsies), for the identification of possible markers (serological,     biochemical, immunological, histological features, expression of cytokines and other     constitutive mucosal proteins from peripheral blood mononuclear cells and mucosal     lymphocytes) that may be of help to diagnose the condition of NCWS and to understand its     pathogenesis.   "
116380|NCT01762566|"     Aim of the investigators' study is to evaluate one of the symptoms described by patients     affected with the so-called not-celiac wheat sensitivity (NCWS). NCWS patients may be     defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat     consumption and improve on Gluten Free Diet (GFD). Among these, patients often report the     appearance of bloating and abdominal pain, and, sometimes, swelling of fingers and face,     shortly after ingestion of wheat. They also refer that swelling tends to last for some hours     and then to disappear on GFD. To our knowledge, this disorder has never been investigated     neither proved.      For the investigators' research, the investigators selected adult patients, both genders,     affected with NCWS. Diagnostic criteria include: 1) symptoms disappearance on GFD, 2) testing     negative for celiac disease [anti-tTG and EMA, and with biopsy Marsh 0-1] and wheat allergy     [serum specific IgE for wheat], 3) positive response to a double-blind placebo-controlled     challenge (DBPC) with wheat or placebo.      Patients will be recruited among subjects referring, as outpatients, to the Department of     Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal     Medicine of the University of Palermo, from January 2012 to October 2013. The investigators     will include patients referring for functional dyspepsia and/or irritable bowel syndrome     (IBS)-like symptoms. All recruited patients must report body's swelling immediately after     wheat ingestion. In all recruited patients, NCWS diagnosis was posed during the previous     years, according to the above mentioned criteria.      Patients, all on GFD for at least 30 days, will undergo to another DBPC with wheat or placebo     (xylose), performed by administering capsules coded as A or B containing wheat or xylose,     respectively. Capsules A or B will be administered once, and then, after 1 week of washout,     patients received the other capsules, given once too. Before and 2 hours after every     challenge, patients will undergo a complete medical examination (measurement of body weight,     height, body mass index [BMI], waist circumference, diameter of thighs, legs, arms, and     fingers), and we will perform bioelectrical impedance analysis and collect blood sampling,     for identification of possible markers (bioelectrical, immunologic, hormonal, etc) that may     help to demonstrate and explain mechanisms of examined symptom.   "
116381|NCT01762553|"     The impact of HIV/AIDS is negatively influencing the affected families and their next     generation. HIV is radiating through the extended families, shifting the life patterns not     only for the parents living with HIV/AIDS (PLH), but also for their children, partners, and     other family members. To help PLHs and their family members, the TEA intervention has been     developed, refined and piloted in the previous study. The goal of this study is to implement     the TEA intervention in a full scale to determine its efficacy and the potential for     enhancing HIV policy and programs that support HIV-affected families to cope with the     challenges in China in responding to the global HIV epidemic.   "
116382|NCT01762540|"     The main purpose of the trial is to advance our knowledge on the possible mechanism     underlying the catabolic effects of long-term treatment with glucocorticoid.   "
116383|NCT01762527|"     This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a     library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure     includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse     effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as     well as cineMR for intra-fractional motion (baseline and every week during RT). Patients     receive standard non-adaptive RT in the first week. Delineations of the bladder on the     Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and     Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used     for the first week of treatment. A margin of 5 mm for intra fractional movement is used.   "
116384|NCT01762514|"     RATIONALE        -  Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma.        -  Radiotherapy may cause adverse effect such as xerostomia and mucositis.        -  Amifostine has the ability of protecting the normal tissue but also has some side          effects.      PURPOSE        -  This phase II trial is to study the protecting effect and safety of different Amifostine          regimens in patients with nasopharyngeal carcinoma.   "
116385|NCT01762501|"     To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration once     per day for 8 weeks in patients with grade I or grade II essential hypertension.   "
117152|NCT01752491|"     This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate     (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma     multiforme (GBM).   "
116389|NCT01762449|"     The primary intent of this study is to add to the body of knowledge on scleroderma patients     with interstitial lung disease. While lung disease is recognized as the leading cause of     death amongst patients with scleroderma, there is not a large body of literature describing     the long-term morbidity and mortality rate of these scleroderma patients. For this reason,     the investigators are following participants of the Scleroderma Lung Study (NCT00004563)     after their participation in that study was concluded. In addition, the investigators will     assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung     Study experienced progression of their scleroderma-related lung disease following the end of     the study.   "
116390|NCT01762436|"     β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on     sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent     cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and     atenolol on SNA and CAP in hypertensive patients.   "
116391|NCT01762423|"     Body contouring surgery has a higher potential for postoperative pain and wound healing     complications. The purpose of this study is to determine if pulsed electromagnetic field     (PEMF) devices can reduce the pain and complications associated with this type of surgery.      Pulsed electromagnetic field (PEMF) devices have been shown to be effective treatments to     decrease healing time in nonunion fractures and pressure ulcers, and to reduce pain in     whiplash injuries, persistent neck pain, and chronic lower back pain. These devices have been     FDA approved for treatment of pain and edema (510(k) number: K070541). More recently, PEMF     devices have been shown to decrease postoperative pain and narcotic use in breast     augmentation patients. This study seeks to determine if PEMF will also cause similar effects     in the more complex procedures performed on body contouring patients. The specific aims of     this study are:        1. Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain          reduction in abdominal body contouring patients.        2. Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain          relievers in abdominal body contouring patients.      PEMF devices have been shown to be effective in reduction of pain and pain medication use in     breast augmentation patients. No literature has shown if PEMF is an effective adjunct to     decrease pain or pain medication use in the abdominal body contouring patient. A decrease in     pain would result in a better experience for patients and a reduction in pain medication may     decrease complications associated with these medications. The PEMF therapy device being used     in this study is a non-significant risk device because it is noninvasive and does not present     a potential for serious risk to the health, safety, or welfare of a subject.   "
116392|NCT01762410|"     Clinical study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid     tumors. The primary objective is to determine the maximum tolerated dose and dose limiting     toxicity of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors   "
116393|NCT01762397|"     The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation     clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food     effect of PMK-S005 after oral administration in healthy male volunteers.   "
116394|NCT01762384|"     Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms     such as loss of control of the bowel or bladder, and may also cause problems with patient's     sex life. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure.     Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery     with mesh is developed in China for Asian Women.      This study is designed to determine the effectiveness and safety of Modified total pelvic     floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the     treatment of uterine or vault prolapse Stage III-IV.      Patients enrolled into the study will be followed up for up to 3 years after surgery.     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before     and after surgery, patient satisfaction through quality of life and sexual function     questionnaires before and after surgery, and peri-operative complication rates will be     evaluated.   "
116395|NCT01762371|"     The primary hypothesis is that Khalifa's therapy has different acute effects in various organ     systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects     might indicate the pathway of the therapy.   "
116396|NCT01762358|"     The primary hypothesis is that Khalifa's therapy brings additional benefit compared to     standard therapy (physiotherapy) for patients with a ruptured anterior cruciate ligament     (ACL).   "
116397|NCT01762345|"     This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device)     by reduction in urine leakage in women with stress urinary incontinence (SUI).   "
116435|NCT01761851|"     Metabolic disorders and malnutrition are well known and have been reported in patients with     chronic liver disease, but the relationship of energy metabolism and changes in nutritional     status in patients on the waiting list for liver transplantation are unexplored. The aim of     this study was to assess the resting energy expenditure (REE) of these patients, identifying     the prevalence of hyper and hypometabolism. In addition, to assess if, malnutrition and     clinical variables were associated with REE and metabolic disorders.   "
119675|NCT01719458|"     In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24     obese individuals and 24 individually matched healthy control subjects and determine     Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.   "
116438|NCT01761812|"     The purpose of this study is to determine the ability of several new MRI techniques (MR     elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient     diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients     with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo     MRI will also be conducted on the prostate specimen to obtain high resolution imaging     correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators     hypothesize that the addition of these three techniques will increase the accuracy,     sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.   "
116439|NCT01761799|"     The primary research aim of this project is to test the effectiveness of a comprehensive,     evidence-based vaccine promotion package implemented in the obstetric setting on increasing     the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis     vaccine.   "
116399|NCT01762319|"     Abnormal uterine bleeding is common in Thai women. Fractional curettage is an diagnostic     procedure of this condition. Traditionally, fractional curettage is performed under local     anesthesia such as paracervical nerve block or intravenous meperidine.      Cervical dilatation using metal cervical dilator is a common method prior to perform     fractional curettage. However, complication from this procedure can be occurred frequently,     for example, uterine perforation, false tract formation and laceration of cervix.      Misoprostol is a prostaglandin E1 analogue which is commonly used in obstetrics and     gynecology. Misoprostol transforms cervical component causing cervical ripening. This is very     helpful for transcervical procedure because cervical dilatation is usually omitted. It can be     prescribed in many route and sublingual route is the most effectiveness. Moreover, WHO     supports the use of misoprostol in obstetrics and gynecology practice.      The hypothesis of this study is that Misoprostol 200 micrograms sublingually is effective     for cervical ripening before performing fractional curettage in patients with abnormal     uterine bleeding Double blind randomised controlled trial was performed using 26 patients in     each group.   "
116400|NCT01762306|"     Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number     of patients, the diagnosis of its cause is performed via fractional curettage under local     anesthesia such as paracervical nerve block or intravenous meperidine.      Pain is one of a common adverse effect of this procedure and this topic should be concerned     by a responsible doctor.      NSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain     control and is as effective as coxib in acute pain management. Because of its cost, easy     accessible and easy administration, Diclofenac Potassium was selected to be used in this     study. Its onset of action is about 1 hour and only one dose of this drug do not cause any     serious side effects.      The hypothesis of this study is that Diclofenac Potassium has an additional effectiveness     for acute pain control in patients undergoing fractional curettage under paracervical nerve     block due to abnormal uterine bleeding Double blind randomised controlled trial was     performed in this study with 45 patients included in each group.   "
116401|NCT01762293|"     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and     Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study     has shown that the toxicity is manageable.      The purpose of this study is to determine whether Famitinib can improve progression free     survival compared with placebo in patients with advanced colorectal cancer who failed in     previous at least two lines of chemotherapy.   "
116402|NCT01762280|"     Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and     antiangiogenic activities. This study is designed to evaluate the safety and tolerability of     Famitinib in patients with solid tumor   "
116403|NCT01762267|"     To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the     metabolic side effects of corticosteroids medications use.   "
116404|NCT01762254|"     To compare the two surgical options in their short-term and long term outcomes in the     management of early left-sided colorectal cancers. The hypothesis is that the incisionless     approach will result in less postoperative pain and wound related complications.   "
116405|NCT01762241|"     The purpose of this study is to investigate the effect of 12 weeks systematically training     using the Xbox Kinect system.      Outcome measures are made on physical function, quality of life, fatigue and metabolic     parameters.   "
116406|NCT01762228|"     This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive     physiology) the effect on the deglutition of two therapeutic treatments with the duration of     2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal     dysphagia:        1. Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using          a natural agonist administrated in the alimentary bolus.        2. Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous          electrical stimuli.      Moreover, with an electroencephalographic study we will assess the effect of both treatments     in the cortical neuroplasticity.   "
116407|NCT01762215|"     This study examines the use of an online social media platform (PatientsLikeMe) to assist     Veterans with epilepsy. The hypothesis is that the online social media platform,     PatientsLikeMe, will improve selected patient-reported outcomes on perceived self-management     skills for patients who engage in the website functions.   "
116409|NCT01762189|"     Thirteen hospitals in China will participate in the study, which aims to provide data on     serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and     estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes.      We hypothesize that the study can be value in identifying and implementing strategies for     risk reduction.   "
116410|NCT01762176|"     To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA),     namely the delayed usual care and early intensive care, in Hong Kong.        -  The delayed usual care reflects the usual treatment practice in Hong Kong        -  The early intensive care includes tight monitoring and immediate adjustment of therapy   "
116411|NCT01762163|"     This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive     study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo     in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a     8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment     there will be an interim analysis.   "
116412|NCT01762150|"     The goal of this clinical research study is to learn the effectiveness of sorafenib combined     with gemcitabine plus cisplatin in the treatment of patients with locally advanced or     metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will     also be studied.   "
116413|NCT01762137|"     In this study, patients with large anterior circulation IAs with neck and fundus morphologies     amenable to either traditional endovascular treatments using coils or reconstruction with the     flow diversion will be randomly assigned to either treatment technique.   "
116414|NCT01762124|"     The purpose of this early feasibility study is to determine how a new transcatheter pulmonary     valve will move and perform once implanted in the right ventricular outflow tract.   "
116623|NCT01759407|"     The purpose of this study is to prospectively compare post-operative pain relief in pediatric     patients undergoing traumatic femur fracture repair who have received either a femoral nerve     block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.   "
116415|NCT01762111|"     The woman fertility decrease with the age and there is a closely link with the ovarian     reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate     the ovarian reserve with specific marker to have a better prediction of the response of the     in vitro fertilization treatment and to have a better rate of pregnancy.      Until now, a lot of clinical criteria (age, duration of the infertility, number of antral     follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at the     retrieval day) was suggested to help for the estimation of the ovarian reserve.      Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best     ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive     and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian hormone can     provide the weak responds at the stimulation and the reverse, the risk of excessive responds     (hyperstimulation). To choose the gonadotropin doses to administrate (stimulation ovarian     hormone) during an In-Vitro Fertilization protocol, we need to know the anti-müllerian     hormone dosage. However, if the anti-müllerian hormone is recognize to evaluate the quantity     of available eggs in the ovaries, his role to determine the quality of these eggs still     discussed.      The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good     indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian     hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro     Fertilization protocol.   "
116416|NCT01762098|"     Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is     asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have     genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal white     loosing. The hysteroscopy can detect the presence or absence of chronic endometritis.      Some studies showed that the endometritis could have an impact on the embryo implantation and     could explain recurrent miscarriages or repeated embryo implantation failures.      The goal of this study is to evaluate the frequency of the chronic endometritis in patients     with recurrent miscarriages or repeated embryo implantation failures   "
116417|NCT01762085|"     Anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic     foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve     pinching and entrapment. Historical risk of 25% annually has been reported to decrease by     >80% to under 5% yearly. Since an open wound precedes the large majority (85%) of amputations     in diabetes, avoidance of ulcer recurrences is important. This study tests the current     academic opinion that nerve decompression will not decrease ulcer recurrence risk. Null     hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.   "
116418|NCT01762072|"     Vitamin B12and n-3 polyunsaturated fatty acids (PUFA) decrease blood homocysteine (Hcy)     concentration. However, the combined effect of these nutrients on Hcy and ferritin, and     C-reactive protein is limited and inconclusive. The objective was to examine the synergistic     effect of vitamin B12 in combination of n-3 PUFA on plasma Hcy, ferritin, and other     biochemical markers. In a randomized controlled trial, thirty eligible subjects were randomly     divided into three groups, and assigned to receive 1000 μg of vitamin B12, 2g fish oil, or     1000 μg vitamin B12 and 2g fish oil respectively for 8 weeks. Plasma phospholipid (PL) fatty     acids and biochemical markers were determined. we hypothesize that combination of vitamin B12     and fish oil have synergistic effect on lowering plasma concentrations of Hcy and ferritin.   "
116419|NCT01762059|"     This study will test the hypothesis that a wearable automated bionic pancreas system that     automatically delivers both insulin and glucagon can improved glycemic control vs. usual in     the outpatient environment.   "
116420|NCT01762046|"     The SUGAR-MGH investigators are studying the influence of inherited gene variants on the     response to two commonly prescribed type 2 diabetes medications, metformin and glipizide.     They hypothesize that variants in genes that are associated with type 2 diabetes or related     traits may impact the effect of anti-diabetic medications. In addition, physiological     responses to an insulin secretagogue or an insulin sensitizer may shed light on the mechanism     of action of reported genetic associations.   "
116421|NCT01762033|"     This Phase 2a study will investigate the efficacy, safety and tolerability of ASONEP™     (sonepcizumab/LT1009) when administered intravenously once a week, every 4 weeks (or cycle),     to subjects with refractory renal cell carcinoma (RCC) until the disease progresses. Subjects     who have failed 3 prior treatments for RCC including vascular endothelial growth factor     (VEGF) and/or mammalian target of rapamycin (mTOR) inhibitors or who have tumors that cannot     be surgically removed will be eligible for screening.   "
116422|NCT01762020|"     To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced     by adjuvant radiation therapy in women with breast cancer.   "
116423|NCT01762007|"     Even successfully managed hypospadias without any complication, voiding problem could be     developed due to the increased urethral resistance. The investigators are trying to analyze     the effect of hypospadias operation on voiding function by checking the detrusor thickness     and urinary nerve growth factor.   "
116424|NCT01761994|"     Continuous renal replacement therapy (CRRT) has been considered as an effective modality for     renal replacement therapy in hemodynamically unstable patients within intensive care unit     (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU     patients often make it equivocal to use anticoagulation. This is a prospective randomized     controlled study to show the difference in filter life span and adverse event between HF1000     (nafamostat mesilate) group and M100 (heparin-free) group.   "
116425|NCT01761981|"     The purpose of this study is to create an institutional and population-based registry of     Haemorrhagic Hereditary Telangiectasia with a prospective survey based on epidemiological     data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.      This study will also describe the occurrence of Haemorrhagic Hereditary Telangiectasia in the     population of HIBA in the Central Hospital, as well as the characteristics of clinical     presentation and evolution.   "
116436|NCT01761838|"     The purpose of this study is to compare changes in spinal stiffness and back muscle activity     between spinal manipulative therapy (SMT) responders, non-responders and asymptomatic     participants. Additionally, the investigators wanted to compare the amount of lumbar     degeneration between SMT responders, non-responders and asymptomatic participants. This study     also determines if the presence of pain modifies post-SMT spinal stiffness and back muscle     activity.   "
116426|NCT01761968|"     This is a multicenter, open label, long-term study testing the long-term safety, tolerability     and efficacy of Givinostat in patients with Polycythemia Vera, Essential Thrombocythemia,     primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia     Myelofibrosis following core protocols in chronic myeloproliferative neoplasms and/or     patient-named compassionate use program (if regulated/allowed by the local regulations, e.g.     for Italy D.M. 8/5/2003 Uso terapeutico di medicinale sottoposto a sperimentazione clinica     published on G.U. n. 173 of 28 July 2003, and the following amendments). Patients will     continue at their last tolerable dose and treatment schedule of Givinostat monotherapy. If     patients previously received Givinostat in combination with other drugs during a core     protocol or a compassionate use program (if regulated/allowed by the local regulations, e.g.     for Italy D.M. 8/5/2003 Uso terapeutico di medicinale sottoposto a sperimentazione clinica     published on G.U. n. 173 of 28 July 2003, and the following amendments), they will be treated     at the last tolerable dose of the combination. Assessment of safety and efficacy will be     performed at each quarterly visit and each visit will also include laboratory tests and ECG     examination. During the visits the clinical benefit will be assessed by Investigator     according to the revised European LeukemiaNet response criteria (for PV and ET) and EUMNET     response criteria (for MF). The dose of Givinostat will be modified for protocol specified     toxicities. The treatment may continue up to Marketing Authorization of Givinostat, currently     planned in the next 5 years (note: only for Germany, this long-term study is initially     limited up to 2 years of treatment). Patients may discontinue study treatment at any time and     remain on study therapy as long as they derive clinical benefit. Safety will be monitored at     each visit throughout the entire duration of the study. In case the approved label will not     cover the whole study population, Givinostat will be provided by the Sponsor to those     patients not fulfilling the criteria for the approved label of the drug that are still     deriving benefit from Givinostat at the time of its commercial availability.   "
116427|NCT01761955|"     The purpose of this study is to evaluate the effects of regular low fat diary consumption on     markers of cardiovascular (CV) and metabolic (cardiometabolic) health including body     composition (% body fat, body weight), blood lipids, blood glucose, arterial compliance,     blood pressure, insulin sensitivity and resting metabolic rate.   "
116428|NCT01761942|"     The purpose of this study is to determine whether omega -3 fatty acids are effective and safe     in treating anorexia nervosa.   "
116429|NCT01761929|"     This is a prospective Phase II study.The purpose of this study is to monitor the side effects     and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while     limiting the dose of radiation to the normal tissues. This will be done using a 5 day     treatment schedule.      The characteristics of patients whose disease remains confined to limited areas in the long     term, compared with those who do not will also be described.   "
116430|NCT01761916|"     The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed     scientifically. There are no reports in the literature and concrete enough to elucidate     important issues, especially in the field of hypertension and pregnancy.      Searches based on current evidence concentrate their focus on the diagnosis of hypertensive     disorders and treatment of these diseases maternofetais repercussions. However, the prognosis     in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most     effective treatment for the control of hypertensive crisis and metabolic and cardiovascular     events after two years of termination of pregnancy require further clarification.      The main idea for developing this research came from the clinical experience with the use of     captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe     preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive     crisis and keeping pressure levels. Following the technical standards of the institution and     during his administration, there were reports of side effects such as dry cough and nausea,     beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the     use of hypotensive.      Alternative therapy, clonidine began to be used in mothers with some restriction on the use     of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not     known yet is how long clonidine reduces high blood pressure and how long to leave stabilized     compared to the use of captopril.      There are no reports in the literature databases, no randomized clinical trials that prove     the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this     particular group of patients, even in comparison with other classes of antihypertensive     drugs, especially captopril, to this purpose.      The investigators' primary assumption is that clonidine has better effectiveness in     decreasing the frequency of pressure peaks when compared with captopril.   "
116431|NCT01761903|"     In this study we are looking at primary focal dystonias, including dystonias of the limbs,     eyes, jaw or face, neck, and vocal chords. This study will use magnet resonance imaging (MRI)     to see how the brain reacts while resting and doing a finger-tapping task.      The investigators will test the hypothesis that disturbances in functional connectivity     within the motor, affective and cognitive basal ganglia networks in primary focal dystonia     (PFD) underlie the motor and non-motor symptoms in this disorder.   "
116433|NCT01761877|"     This study has two purposes. One is to determine if daily sulindac decreases breast density;     a risk factor for breast cancer development. The second is to determine whether sulindac     reduces pain and stiffness associated with regular use of aromatase inhibitors given for the     treatment of breast cancer.   "
116434|NCT01761864|"     Osteoarthritis is a common problem in primary care. Long-term use of non-steroidal     anti-inflammatory drugs (NSAIDs) for pain relief can lead to serious (gastro-intestinal,     cardiovascular and renal) adverse events, that can even result in death. NSAIDs differ in     their risk of side effects. Opoid analgesics are sometimes used as an alternative for NSAIDs     in patients with osteoarthritis. However, these drugs also can lead to serious adverse     events. Simple analgesics are first line treatment in patients with osteoarthritis. NSAIDs     and opoid analgesics should be avoided whenever possible.      Farmaka (www.farmaka.be) is a non-profit organisation that operates a nationwide academic     detailing service in Belgium since 2006. The academic detailing exists of face-to-face     educational visits to general practitioners in their practice by a trained visitor with a     medical science degree. The aim of these visits is to improve the quality of drug prescribing     in primary care. Small scale experiments in the past showed that academic detailing can     indeed improve prescribing behavior.      The current study wants to examine if nationwide academic detailing on appropriate     prescribing of analgesics for chronic pain in osteoarthritis results in a better GP's     prescribing behavior.      Another research question is whether physician-visitors have more influence on prescribing     than non-physician visitors.      It is also interesting to examine if the effect of a visit is larger if there exists a     longstanding relationship between the academic detailer and the GP.      About 4.000 general practices are located in a region where academic detailers of Farmaka are     operational and have received a visit at least once before. All these practices will be     divided into two study groups in a random manner.      The first group of practices will belong to the treatment group. GP's from this group will be     offered a face-to-face visit on appropriate prescribing of analgesics for chronic pain in     osteoarthritis. The visits will take place between February and June 2013.      The second group of practices will serve as a control group. GP's from these practices won't     be offered any visit at all during the year 2013.      Reimbursement data for all GP's are available by request from the Belgian Intermutualistic     Agency (IMA). IMA data for 2013 will be available by the end of 2014. These data will allow     comparison between the treatment and control group on the amound and type of prescriptions     for analgesics in patients with chronic osteoarthritis pain.      A comparison of the prescriptions of practices that participate in the study and the     prescriptions of in practices that don't participate is also possible.      The project is funded by the Federal Agency for Medicines and Health Products. We hypothesize     that        -  the academic detailing visits to GP practices on prescribing of analgesics for chronic          pain in osteoarthritis will improve prescribing of analgesics by at least 5%        -  the personal relation between the GP and the academic detailer, expressed as the number          of previous visits, is an important effect modifier   "
116437|NCT01761825|"     The purpose of this study is to determine whether Ivabradine is an effective treatment for     postural tachycardia syndrome.   "
123961|NCT01663233|"     This study will assess whether LCZ696 when used in combination with amlodipine will provide     greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not     adequately responsive to amlodipine therapy.   "
116450|NCT01761656|"     The purpose of this study is to determine whether preoperative loading dose atorvastatin can     prevent perioperative myocardial infarction during angiography and main adverse cardiac     events 1 month after operation in stable angina, unstable angina and acute non-ST-segment     elevation myocardial infarction patients undergoing elective coronary angiography and PCI,     and determine whether its mechanisms are associated with microcirculation resistance.   "
116440|NCT01761786|"     Rationale: the use of antiplatelet drugs (i.e. clopidogrel, ticagrelor or prasugrel) is     crucial in the treatment of patients undergoing percutaneous coronary intervention (PCI) with     stent implantation to prevent atherothrombotic events. Ticagrelor and prasugrel are more     effective in preventing atherothrombotic events, but with a higher risk of bleeding     complications, compared to clopidogrel. Clopidogrel is converted into its active metabolite     by CYP2C19. Carriers of the non functional CYP2C19*2 and *3 alleles have an impaired CYP2C19     capacity, making clopidogrel less effective. For these subjects ticagrelor or prasugrel is an     alternative.      Objective: to assess the efficacy, safety and cost-effectiveness of the CYP2C19 genotype     guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19*2 and     *3 allele and ticagrelor or prasugrel in carriers of a CYP2C19*2 and *3 allele in STEMI     patients.      Intervention: the intervention group will be genotyped for CYP2C19*2 and *3 allele variants     within 48 hours after PCI. Carriers will receive either ticagrelor (90 mg twice daily) or     prasugrel (10 mg once daily or 5 mg once daily if the patient is older than 75 years or has a     body weight < 60 kg), according to local standards. Non-carriers will be treated with     clopidogrel (75 mg once daily). The control group receives either ticagrelor or prasugrel,     according to local standards at the same dosage as the CYP2C19*2 or *3 carriers in the     intervention group. The antiplatelet drug will be continued for one year after PCI. The     follow-up duration will be one year using follow-up questionnaires.   "
116441|NCT01761773|"     The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of     cabozantinib in adult subjects with impaired renal function compared with healthy adult     subjects. Another objective is to assess the safety and tolerability of cabozantinib in these     adult subjects.   "
116442|NCT01761760|"     Investigators will be evaluating an online video-game-based smoking cessation intervention     that will overcome barriers to treatment such as cost and sustainability. This videogame will     be the first of its kind, based on an evidence-based intervention shown to promote smoking     abstinence. The findings from this research will be of great public health significance     because of the unprecedented reach and relatively low cost, as well as the potential for     similar interventions to be developed for other health problems, such as alcohol or drug     abuse and medication adherence for chronic illnesses   "
116443|NCT01761747|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the drug is being studied. It also means that the FDA has not     yet approved ponatinib for use in patients, including people with your type of cancer.      In order to participate on this study, it must first be determined whether or not a patient's     lung or head and neck squamous cell cancer (SCC) has an alteration in FGFR kinase is made     from an experimental test on your squamous cell cancer tissue sample. This experimental test     is a genetic test or genotyping test, which is a method used to study a tumor's genes.     The results are for research purposes only and are not considered genetic testing for the     purpose of diagnosing medical conditions. Cancers develop as a result of changes that occur     in human genetic material (DNA); these changes are called mutations or alterations. This     experimental test gives no information about any of the genes in the normal cells of the     patient's body, but it helps identify abnormal genes (like FGFR kinase mutations or     alterations) usually found only in cancer cells. We will use this experimental test to     determine whether or not a tumor contains a required alteration/mutation and thus may respond     to ponatinib.      Ponatinib is an investigational, oral anti-cancer drug designed to inhibit abnormal proteins     found in cancer cells and may cause those cancer cells to die. In laboratory testing,     ponatinib has been shown to inhibit a family of proteins called FGFR kinases, and this     genetic alteration/mutation has been found in some squamous cell lung cancers. There is     laboratory evidence that alterations/mutations in FGFR kinases in squamous cell lung cancers     may be driving the growth of these tumors and that inhibiting these FGFR kinases with     ponatinib may decrease or stop the growth of lung SCC.      In this research study, we are looking to see if the study drug, ponatinib, can keep cancer     from growing.   "
116444|NCT01761734|"     Influenza is an important and potentially preventable cause of morbidity and mortality, yet     only 46% of U.S. adults were vaccinated by the end of the 2011-12 influenza season despite     influenza vaccination being widely recommended, effective, and safe. Influenza vaccination     rates are even lower in racial/ethnic minority groups. In order to address the problem of low     influenza vaccination rates in minority adults, we plan to build on the well-accepted     practice of immunization recall-reminders and the emerging practice of using text message to     pilot the feasibility of using text messaging to improve influenza vaccination coverage rates     in a low health literacy, largely minority, publicly insured adult population.   "
116445|NCT01761721|"     The propose of this study is to describe recovery and experience of pain and health related     quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial     Cancer or Atypical Complex Hyperplasia.   "
116446|NCT01761708|"     Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired     with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh     technology have been developed for the specific indication of small ventral hernias; this     technique is very attractive because the mesh can be introduced through a nearly invisible     scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the     viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No     literature is available on the adequate size of mesh needed to repair a hernia defect of an     umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a     large mesh device. Small hernias might benefit of repair with a small mesh device so no     enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size     to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective     cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for     the different sizes of hernia defects. The study was stopped prematurely because of the     perception of an unacceptably high rate of mesh infection. This new study will     retrospectively examine the incidence of mesh infection in all ventral hernias repaired with     a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.   "
116449|NCT01761669|"     Working hypothesis and aims: The aim of our study is to investigate whether vitamin D     deficiency could cause increased thrombin generation and a hypercoagulable state healthy     volunteers.      Methods:      In total 400 healthy volunteers are planned for inclusion in this trial. After signing an     informed consent two blood samples will be obtained from each participant.      Expected results: invastigator expect to find that volunteers with vitamin D deficiency will     have thrombin generation curve compatible with hypercoagulable state and returning to normal     after treatment with vitamin D   "
116451|NCT01761643|"     CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration     project to determine if the use of a text-message based adherence intervention (iTAB)     improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.   "
116452|NCT01761630|"     Asthma is a disease characterized by inflammation in the airways. The body naturally makes     compounds that reduce inflammation. Unfortunately, for patients with severe asthma, the     pathway these compounds use to reduce inflammation seems to be perturbed. Investigators have     chosen to focus on the anti-inflammatory compounds called lipoxins and how they work through     the ALX Axis, a name given to the ALX receptor pathway and its ligands. Work from the     Brigham and Women's Hospital has suggested that in patients with severe asthma, the ALX axis     may not work properly and therefore may not shut off inflammation as expected. Also, there is     information to suggest that in some cases, steroids (prednisone and similar drugs), which are     commonly used to treat asthma, may affect the ALX axis in a negative way, paradoxically     making the inflammation worse instead of better.      As part of the NIH Severe Asthma Research Program the Asthma Research Center's goal is to     identify what causes the problems in the ALX axis in severe asthma. To do so, participants     with severe asthma will be compared to participants with milder forms of asthma.     Investigators will use samples taken directly from the lungs of people with asthma, as well     as blood, urine and CT scans of the lungs to better understand how the ALX axis changes both     before and after corticosteroid treatment and throughout a three year span. Participants will     come into the Asthma Research Center to have the procedures done.      Investigators expect participants will perform breathing tests and complete questionnaires     and diaries. To better understand if corticosteroids negatively affect the ALX axis in severe     asthma, researchers will take samples before and after a one time steroid injection     equivalent to a prednisone treatment for asthma. Participants will perform two bronchoscopy     procedures, before and after corticosteroid treatment, where biopsies and cells will be     obtained from the participant's lungs. Investigators will use these samples to observe any     changes that the corticosteroid may have on the ALX axis. At the end of the study,     researchers at the Brigham and Women's Hospital expect to understand the ALX axis in such a     way that will allow them to formulate new therapies and drug targets to treat people with     asthma, especially severe asthma, more effectively.      In Boston, this study will be run together by the Asthma Research Center at the Brigham and     Women's Hospital (adults) and Boston Children's Hospital (children).   "
116453|NCT01761617|"     A 12-week randomized controlled trial (RCT) for chronic low back pain in predominantly     minority populations comparing yoga classes once/week vs. twice/week. Primary outcomes are     pain intensity and measure of disability; secondary outcomes are pain medication use,     treatment adherence, and health-related quality of life.   "
116454|NCT01761604|"     The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily     function and reduces quality of life. The sphenopalatine ganglion, located in the posterior     part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the     sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in     use to accomplish this are either cumbersome for the patient or invasive regarding the     puncture of structures.      The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator     device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We     are expecting that this new device will provide at least the same pain relief as the     previously described approaches. However, this nasal applicator is intended to be an easy and     non invasive method for office use.   "
116455|NCT01761591|"     The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit     and impact on resource utilization of percutaneous coronary interventions (PCI) with the     Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS)     implantable via direct stenting or after lesion pre-dilation, in patients with coronary     lesions that are eligible for direct stenting and who are recruited and treated so as to     reflect real-life routine practice.   "
116456|NCT01761578|"     This prospective, multicentre, open labeled, single arm, first in man interventional     investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment     of patients with single de novo lesion of a native coronary artery with mandatory balloon     predilatation.   "
116457|NCT01761565|"     Determine the plasma concentration profile after single and multiple dosing of Sufentanil     NanoTabs   "
116458|NCT01761552|"     To demonstrate that the use of Sugammadex enables physicians to perform early extubation in     the operating room in ASA 4 & 4E patients      Primary endpoint:      • Extubation in the operating room before transfer to the PACU or ICU versus keeping the     patient intubated when transferred.      Secondary endpoints:      • Time to extubation - measure the difference in time from application of the surgical     dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery,     on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine     practice at Hadassa hospital for ASA IV patients.)   "
116459|NCT01761539|"     Fluid resuscitation for pancreatitis is recommended given evidence that hemoconcentration is     associated with necrosis. However, there is insufficient evidence to support whether     resuscitation should be moderate or aggressive. In this study the investigators aim to     compare the clinical outcome associated with these strategies in a clinical randomized     fashion to determine the optimal treatment of acute pancreatitis.   "
116460|NCT01761526|"     To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese     and Caucasian Female and Male Healthy Subjects.   "
116461|NCT01761513|"     A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of     YH4808 after repeated Oral administration and Postprandial state in healthy volunteers   "
116462|NCT01761500|"     Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This     study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol     in Chinese children and adolescents with Non-Hodgkin's lymphoma.   "
117153|NCT01752478|"     The purpose of this study to is to determine the incidence of post-operative ptosis in     patients undergoing vitreoretinal surgery. An additional purpose is to identify pre-operative     and intra-operative factors which correlate to the development of post-operative ptosis in     vitreoretinal surgery cases.   "
116463|NCT01761487|"     There is an urgent need to control the current national outbreak of Carbapenem-resistent     Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times     higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%,     respectively).      In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of     Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for     Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators     have shown that the investigators' SDD regimen is effective for decolonization patients     colonized with CRKP.      The investigators' assumption is that a higher dose of polymyxin E together with gentamicin     (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of     drug inactivation in the gut, thereby reaching CRKP carriage eradication.   "
116489|NCT01761149|"     Extensive clinical studies have shown that intraoperative infusion high dose of remifentanil     (0.2ug/kg/min) induced postoperative hyperalgesia. Recent experimental study however suggests     that higher dose of remifentanil may attenuate postoperative hyperalgesia. Thus, the present     study is designed as a proof of principle study and hypothesizes that higher dose of     remifentanil may reduce postoperative pain in patients.   "
116464|NCT01761474|"     Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause     abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue     scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients     without complications, compared with air insufflation. However, differences in patient     suffering between CO2 and air insufflation after ERCP depending on sedation protocols have     not been reported. We therefore planned prospective, double-blind, randomized, controlled     study with CO2 and air insufflation during ERCP depending on sedation protocol.   "
116465|NCT01761461|"     The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to     compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.   "
116466|NCT01761448|"     The object of this study is to determine the improvement obtained in long-term adherence to     home-based rehabilitation programs (cardiac rehabilitation phase III) when following a guided     exercise training prescription supervised by an innovative system specifically designed to     optimize the training effects and maximize the patient´s security compared to the standard     care given in each country for this kind of patients. The innovated Guided Exercise- (GEx)-     System consists of a sensor that monitors vital parameters during exercise training sessions     used in combination with software that provides feedback to the patient based on the training     prescription provided by the doctor and the level exertion monitored. This main trial follows     a pretrial in which the used ECG sensor was validated at hospital during rehabilitation phase     II and the practicability of the vest with this integrated ECG sensor and the possibility of     technical problems of this innovative GEx- system were tested in real-life of the patient     during phase III at home (ID 11-094).   "
116467|NCT01761435|"     Randomized, multicenter, open label trial to compare safety and efficacy of two doses     stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.   "
116468|NCT01761422|"     The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for     myocardial inflammation.   "
116469|NCT01761409|"     Endometrial cancer is one of the most common gynecological cancers, and the incidence     increasing in the world. However, there isn't any large sample data of endometrial cancer     reported in China. Thus Endometrial cancer project of Guangdong province conduct a large     multicentre clinical investigation about endometrial cancer.   "
116470|NCT01761396|"     This research is being done to compare two types of talk therapy to see which is most     effective in helping school children with anxiety disorders. The investigators will compare     usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered     by the school mental health counselors to see if they help children with anxiety disorders to     feel less scared or worried.   "
116471|NCT01761383|"     The purpose of this study is to determine whether the use of Nintendo Wii will help improve     negative symptoms of Schizophrenia and quality of life of patients with chronic     Schizophrenia.   "
116472|NCT01761370|"     The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in     the treatment of patients with Non alcoholic Steatohepatitis (NASH).   "
116473|NCT01761357|"     The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G     (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related     quality of life measured by questionnaire called SF-36, six months after a transcatheter     aortic valve replacement in older patients. During the comprehensive geriatric assessment     realized before the valve implantation, the following data are recorded and their impact of     the health related quality of life will also be analysed: comorbidity, age, depression,     functional status, the cognitive impairment and malnutrition.   "
116474|NCT01761344|"     Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and     blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary     hypertension. The overproduction of aldosteron might in some cases be due to unilateral     hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these     cases the adrenal can be removed and the patient cured of hypertension. The clinical     evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective     sampling of blood from the adrenal veins to determine lateralization of overproduction. This     is executed as an interventional radiological procedure.      The adrenal vein sampling is challenging, and success is determined by measuring another     adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample.     By routine laboratory assays the procedure is evaluated after the patient has been discharged     from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the     radiologist to draw new samples during the same procedure if the first set of samples is     unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful     tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.   "
116475|NCT01761331|"     The purpose of this prospective randomized three armed, multi center study is to compare the     effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile     colic. Group A will get standardized minimal acupuncture in LI4, group B will get     individualized acupuncture in different points according to symptoms and group C will not get     acupuncture. Parents (who register the infants crying) and the nurse they meet at the study     CHC are blinded.   "
117411|NCT01749228|"     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,     two-period, crossover pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fed     condition in healthy, adult human subjects.   "
116490|NCT01761136|"     The objective of this study was to evaluate the safety and immunogenicity of Haemophilus     influenzae type b vaccine in different injection site.   "
116491|NCT01761123|"     the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an     adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using     a radio controlled capsule. The secondary objective is to evaluate the immune response     (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.   "
116624|NCT01759394|"     A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter-     and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as     Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to     healthy subjects Receiving a low-fat Meal.   "
116476|NCT01761318|"     The most important cause of mortality amongst DM2 patients is cardiovascular disease. An     early finding of cardiovascular disease in DM2 and obesity is diastolic dysfunction.     Diastolic dysfunction is an independent predictor of mortality and has been shown to improve     in patients on a low calorie diet. The improvement of diastolic function was associated with     a reduction in triglyceride accumulation in the heart and liver. A relatively new widely     prescribed therapeutic agent for DM2 patients is Liraglutide (Victoza®). Liraglutide is a     Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood     pressure and body weight. Next to the induction of weight loss, which is potentially     beneficial for cardiac function, GLP-1 therapy might have a direct advantageous effect on the     cardiovascular system. However, the effect of Liraglutide on cardiovascular function has not     been investigated yet. The investigators hypothesize that treatment of DM2 patients with     Liraglutide is associated with improvement of cardiovascular function and a reduction of     triglyceride accumulation in end-organs.   "
116477|NCT01761305|"     Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in     children. Recent reviews on bracing and exercise treatment have provided some evidence for     effect of these interventions. The purpose of this study is to compare the effectiveness of     night time bracing, scoliosis specific exercises and physical activity prescription in     adolescents with idiopathic scoliosis.   "
116478|NCT01761292|"     This is a 2-part, phase 2 study to assess the effects of Givinostat on muscle histologic     parameters and on clinical parameters in ambulant children with DMD. The safety,     tolerability, and pharmacokinetics of Givinostat will also be assessed. All children treated     in part 2 continue in the extension phase, for a maximum of an additional 12 months.   "
116479|NCT01761279|"     Current standard practice is to remove all colonic polyps found during colonoscopy as it has     not been possible to distinguish between polyps with some malignant potential (adenomatous)     and those with negligable malignant potential (non-adenomatous).      Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish     between these two types of polyps by examining minute surface details.      i-Scan is a new digital enhancement method that aims to enhance surface details and may     enable similar accurate distinction between adenomatous and non-adenomatous polyps.      Hypothesis:      High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo     assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.   "
116480|NCT01761266|"     E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to     compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic     treatment in subjects with unresectable Hepatocellular Carcinoma (HCC).   "
116481|NCT01761253|"     This study will involve the evaluation of the cost profile of about approximately 241,000     patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network     AND 226,000 members of a large self insured union trust fund). We will test the hypothesis     that as comorbidity scores exceed three-four, patients will have an exponential increase in     average yearly cost with a parallel exponential increase in cost variability.      We will examine the relationship between comorbidity and health insurance costs and     variability in costs among patients enrolled in health plans.   "
116482|NCT01761240|"     This study is a Phase I, first in human, dose-escalation study of MORAb-066, an     investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets     TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell     lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety,     tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify     the MTD when MORAb-066 is administered IV once weekly on a 28-day cycle.   "
116483|NCT01761227|"     Purpose: The purpose of this study is to examine the efficacy and safety of Fufangdanshen     Tablets in patients with mild to moderate vascular dementia (VaD).   "
116484|NCT01761214|"     Bronchiectasis is a chronic disease arises from progressive airway inflammation and     infection. It has been postulated that bacterial infection triggers intense airway     inflammation leading to acute exacerbation of bronchiectasis. Antibiotics have been the most     potent medications for the treatment of bronchiectasis, however, the sputum bacterial load     and inflammatory indices at steady-state and exacerbation remain largely unknown. The     investigation might shed light on the roles that antibiotics play in acute exacerbation of     bronchiectasis and uncover the mechanisms on why a subgroup of individuals do not respond     satisfactorily.   "
116485|NCT01761201|"     A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing     levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients     eligible for liver transplantation.      Patients over 18 years of age on the waiting list for liver transplantation.      Sample size: n=870 patients.      HYPOTHESIS      Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for     liver transplantation, is safer and not less effective than isoniazid treatment begun after     transplantation when liver function is stable.   "
116486|NCT01761188|"     -  Background:the ablation outcomes for the treatment of persistent atrial fibrillation are          not as satisfactory as paroxsymal AF. The successful rate ranges from 30%-55%. We found          a new novel strategy for the modification of LA substrate during sinus rhythm based on          our pilot study.        -  Hypothesis: our new method may be more effective than conventional strategy.        -  Objectives:The primary objective of this investigation is to compare the efficacy of two          different AF ablation strategies in patients with persistent AF:Study Group: CPVI plus          electrophysiologic substrate ablation in the left atrium during sinus rhythm (          STABLE-SR);Control Group: conventional stepwise approach for persistent AF(CPVI + Lines          +CFE) .The secondary objectives of this investigation are to evaluate and compare the          safety and procedural characteristics of both groups.        -  Sample size: 220        -  Time line: 2013 Q1-2014 Q2   "
116487|NCT01761175|"     The purpose of this study is to compare the rate of complete sensory block at 30 minutes     following ultrasound-guided single injection infraclavicular block and ultrasound-guided     double injection axillary block. The investigators research hypothesis is that both blocks     will show comparable rates of complete sensory block at 30 minutes.   "
116488|NCT01761162|"     The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI     Pacemaker System when used under specific MRI conditions.   "
116492|NCT01761110|"     The main goal of this study is to pilot test the community-based buprenorphine treatment     (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk     behaviors. Two groups of participants will be followed for 60 days, with 3 research visits.     One group will be enrolled prior to the CBBT intervention (pre-intervention), and one group     after the CBBT intervention (post-intervention). Data sources will include questionnaires,     urine toxicology tests, and medical record data. We hypothesize that compared to the     participants in the pre-intervention group, participants in the post-intervention group will     be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce high-risk     HIV risk behaviors.   "
116493|NCT01761097|"     Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of     cancer at an early stage, as well as detection and removal of polyps through gold standard     colonoscopy examination decreases mortality from the disease. However colonoscopy has a well     documented miss rate, with some areas of the bowel difficult to visualise and neoplastic     lesions potentially hidden behind folds in the colon.      The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten     mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled     withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current     colonoscopes without modification. In this single centre, randomised controlled trial, the     investigators aim to assess the performance of the current gold standard colonoscopic     examination against the current gold standard colonoscopic examination with the Endocuff©     attached to the colonoscope.      The investigators aim to recruit 300 patients (150 in each group) who have previously been     identified to have colonic polyps or cancers undergoing surveillance colonoscopy following     NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on     gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator     guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or     cancer will be invited to participate and those agreeing will be randomly allocated to one or     other technique.   "
116494|NCT01761084|"     The long-term goal of our research team is to conduct a large multicentre study to evaluate     whether tailored home exercise can prevent fractures in high-risk individuals. The proposed     project will address the feasibility of such a trial, but will also evaluate the effect of     exercise on quality of life, posture and many other outcomes important to individuals with     vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver     the intervention (or social visit for controls) using a similar model to previous work by our     team and others. The purpose of this pilot study is determining the feasibility of     recruitment, retention and adherence of an international multicentre randomized controlled     study evaluating the efficacy of thrice-weekly home exercise for one year among women with     vertebral fracture. As secondary objectives, the investigators will examine the effects of     exercise on function, balance, quality of life, pain, falls and fractures. The primary     hypothesis is that the investigators will successfully recruit and retain the target sample,     and achieve an adherence rate of 60%.   "
116495|NCT01761071|"     The investigators performed this study to investigate pain prevention of preoperative topical     nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK) using time     serial pain scoring.   "
116496|NCT01761058|"     The overall goal of this proposal is to better understand the basis of airway remodeling in     severe asthma and how remodeling changes overtime. The investigators propose to study a well     characterized cohort of individuals with severe asthma using a multidisciplinary     state-of-the-art-approach.   "
116497|NCT01761045|"     The objective of this study is to confirm that Monosodium L-Glutamate (MSG) supplementation,     both alone or in combination with Nucleic Acid (IMP), enhances satiety and decreases food     intakes at the next meal in healthy female adults.   "
116498|NCT01761032|"     In the proposed study, the investigators will assess the brain's dopamine response to UVR     light in individuals who use tanning beds both frequently and infrequently.   "
116499|NCT01761019|"     Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective     when used as monotherapy (without other oral medicines or creams) than are newer biologic     injected drugs. However, these oral medications are also less expensive than biologic agents     and may be safer for use in some patients. The purpose of this study is to determine if     adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex     topical suspension), will improve the severity of psoriasis in patients already on     methotrexate or acitretin and to determine if adding this topical suspension will reduce the     desire of such patients to switch to a biologic agent to treat their psoriasis.   "
116500|NCT01761006|"     The purpose of this research study is to determine whether exhaled nitric oxide (FeNO) goes     up during an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and whether     the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation.   "
116501|NCT01760993|"     The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80,     100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.   "
116502|NCT01760980|"     The objective of this study is to assess the bioequivalence of the test product, Exemestane     25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin®     (exemestane) 25 mg tablets of Pharmacia & Upjohn Company, Division of Pfizer Inc., New York,     United States of America in healthy male and postmenopausal female subjects, under fasting     conditions   "
116522|NCT01760720|"     Based on our previous success with the intervention pilot (R34MH083512), we conducted this     randomized controlled trial (MMT CARE), which will integrate behavioral intervention     components with a primarily pharmacological model of MMT. The intervention focuses on     treatment adherence and effective outcomes by reducing stigmatizing attitudes and behaviors     among service providers, enhancing their communication skills, and improving their     interactions with and support of their clients' behavior changes. Our goal is to bring a     contextual change to support a protective environment for clients' motivation and capacity in     order to reduce their HIV risk. The findings could benefit not only China but also the global     community by effectively combining interventions for controlling the HIV epidemic.   "
116523|NCT01760707|"     The purpose of the study was to investigate the effects of training on the exercise     capability, balance performance, and microcirculation. Furthermore, to search the possible     underlying mechanisms.   "
116503|NCT01760967|"     Background:      Dexmedetomidine, a highly selective arfa2-adrenergic agonist, is known to be a unique     sedative agent which causes less acute tolerance, drug addiction and withdrawal compared with     gamma-aminobutyrate (GABA) agonists. Dexmedetomidine was approved for short-term ICU sedation     in 2004 in Japan, and it has been used particularly for surgical ICU patients. In August 2010     dexmedetomidine was approved in Japan for sedation lasting more than 24 hours.      Recent evidence demonstrated that dexmedetomidine has organ protective effects including     neuroprotection, cardioprotection, renal protection, gastrointestinal tract action, and     anti-inflammatory action. Dexmedetomidine was shown to significantly decrease the infarct     size in isolated rat hearts. Additionally, dexmedetomidine exhibited a preconditioning effect     against ischemic injury in hippocampal slices, and this result was considered an apoptosis     suppression effect of dexmedetomidine. Aydin C et al reported that dexmedetomidine enhanced     the spontaneous contractions of the ileum in peritonitis rats compared with propofol and     midazolam. Taniguchi and colleagues demonstrated that dexmedetomidine reduced high mortality     rates and the plasma cytokine concentrations, interleukin-6 and tumor necrosis factor alpha     in endotoxemic rats.      A meta-analysis has shown that perioperative alfa2-adrenergic agonists, including     dexmedetomidine infusion, decreased cardiovascular events on patients undergoing cardiac     surgery. Dexmedetomidine treated patients undergoing thoracotomy indicated increase in urine     output, reduction in serum creatinine, and the suppression of diuretics in a randomized     placebo-controlled double-blind study. Septic patients receiving dexmedetomidine had improved     28-day mortality rates compared with septic patients receiving lorazepam in a sub-group     analysis of MENDS randomized controlled trial.      These positive effects of dexmedetomidine on the cardiovascular system, neurons, kidneys,     gastrointestinal tract action, and an anti-inflammatory action, are expected to improve     mortality in septic patients. However, large clinical research studies have not been     conducted yet. We designed and conducted the DESIRE trial (DExmedetomidine for Sepsis in ICU     Randomized Evaluation trial) to test a hypothesis that dexmedetomidine may improve clinical     outcome and has these organ protective effects on septic patients.      Objective:      To determine whether dexmedetomidine improves clinical outcome and has organ protective     effects on septic patients.   "
116504|NCT01760954|"     A randomized study evaluating the continued safety and efficacy of elagolix in the management     of moderate to severe endometriosis-associated pain in adult pre-menopausal female subjects.   "
116505|NCT01760941|"     This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400     flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative     radiation therapy for patients with symptomatic bony metastatic disease who are currently     enrolled in hospice. Treatment planning and delivery of palliative radiotherapy will utilize     standard of care techniques.   "
116506|NCT01760928|"     A selection of asthma patients were followed during preparation to climb the Aconcagua     mountain. The primary goal of this follow up was to optimize patients' asthma status. Also     during expedition, these patients were daily consulted by a physician. All data obtained     during preparation and expedition will now be retrospectively analyzed.   "
116507|NCT01760915|"     The overall goal of this proposal is to better understand the basis of structural airway     changes in severe asthma and how asthma exacerbations may contribute to their progression     over time. The investigators propose to study a well-characterized cohort of adult and     pediatric subjects with asthma using a multidisciplinary state-of-the-art approach. We     hypothesize that severe asthma exacerbations, in some patients, are associated with     incomplete recovery and activation of airway inflammatory cells in a regional distribution.     The end result is a more permanent and less reversible airway obstruction that is a prominent     feature of severe asthma.   "
116508|NCT01760902|"     South Carolina has many gaps in health status of our citizens. Some of the biggest gaps are     higher cancer rates among African Americans. The purpose of this study is to find people who     have increased inflammation and study how well a community-based dietary and physical     activity program works at reducing the risk of African Americans developing     inflammation-related diseases.   "
116509|NCT01760889|"     The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or     100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative     Symptoms.   "
116510|NCT01760876|"     Since polymers have been identified as a possible cause of late complications of drug eluting     stents, new stents are being designed to improve polymers' biocompatibility or to bond drugs     on stents without polymers.      Biolimus A9 is the therapeutic agent used in the BioFreedom drug coated stent. Biolimus A9 is     a proprietary semi-synthetic sirolimus derivative. It is highly lipophilic, rapidly absorbed     in tissues, and able to reversibly inhibit growth factor-stimulated cell proliferation.      In this study, we use intracoronary optical coherence tomography (OCT) to evaluate the     BioFreedom Stents after implantation regarding endovascular healing over time as primary     objective; and also to evaluate secondary OCT, angiographic and clinical outcomes at various     specific time points.   "
116511|NCT01760863|"     The primary purpose of this study is to compare the re-infection rates in patients undergoing     2-stage revision arthroplasty who receive additional oral antibiotic therapy to those     patients who received in-hospital perioperative antibiotic only. Patients will be monitored     for re-infection following hospital discharge, defined as deep infection of the joint     space/capsule that requires return to the operating room within 24-months of the     re-implantation procedure.   "
116512|NCT01760850|"     This pilot clinical trial studies a breast and cervical cancer educational intervention for     Latinas in Western New York. An outreach program may help minority cancer patients overcome     problems that keep them from receiving cancer screening.   "
116513|NCT01760837|"     Based on the current knowledge, the investigators hypothesized that most children with milk     allergy in Israel would be able to ingest baked milk products daily, thus benefiting from     improved nutrition and dietary variety and protect them from accidental exposure to     milk-containing products.      Objective: The aim of our study is to examine the outcome of cow's milk allergic patients who     incorporated baked milk products into their diets. In order to recruit a large population, a     multicenter study across many hospital related allergy clinics in Israel will be conducted.      Methods      Participants The study protocol is essentially as described previously (12). Subjects will be     recruited from the relevant allergy clinics involved in this project. The study will be     approved by the local Institutional Review Board, and informed consent will be obtained.      Eligible subjects will be aged 1 to 18 years, had positive skin prick test (SPT) responses or     detectable serum milk-specific IgE, and had a history of an allergic reaction to milk within     6 months before study entry or milk-specific IgE levels or SPT responses greater than 95% of     predicted value for clinical reactivity (if <2 years old, a level >5 kUA/L; if >2 years old,     a level >15 kUA/L; SPT mean wheal diameter, >8 mm.      Exclusion criteria include a negative SPT response and an undetectable milk-specific IgE     level; a history of anaphylaxis requiring intensive care unit hospitalization; unstable     asthma or a history of intubation related to asthma; previously diagnosed milk-induced     eosinophilic gastroenteropathy; a recent reaction (within 6 months) to a baked milk product;     or pregnancy.      Design      Active group - Based on the results of the initial baked milk oral challenge, subjects will     be categorized as baked milk reactive or baked milk tolerant (group I and II, respectively).     Group I subjects will be instructed to completely avoid all forms of milk but will be offered     a repeat challenge 6 or more months from the initial challenge. Group II subjects will be     instructed to incorporate baked milk products daily into their diets and after 6 or more     months will be offered challenges to baked cheese products (pizza). Similarly, after 6 or     more months, baked cheese-tolerant children will be offered challenges to unheated milk.      The two groups will be followed at least 2 years and the outcome as well as other parameters     (accidental exposure, use of medication, quality of life, appearance of related symptoms,     ect) will be compared between the 2 groups.      Baked milk - Each muffin (or the equivalent piece of cake) contains ~ 1.3 g of milk protein.     The muffins/cake will be prepared according to instructed recipe and will be baked at 180     degree C for 30 minutes. Baked milk-tolerant subjects will be instructed to ingest 1 to 3     servings per day of store-bought baked milk products with milk listed as a minor ingredient     (third or less) or home-baked products with an equivalent amount of milk protein.      Baked cheese - Cheese pizza (Maadanot), will be baked at 2200 C for 13 minutes or longer.     Baked cheese-tolerant subjects will be instructed to eat any brand of well-cooked cheese     pizza 4 to 7 times weekly and limited to 1 daily serving.      Unheated milk - Challenges will be performed with skim milk totaling 240 mL (or other product     containing 8-10 g of unheated milk protein, such as yogurt).      Follow-up allergy evaluations - Blood and serum samples will be collected for the measurement     of IgE and IgG4 antibodies to milk, casein, and b-lactoglobulin by using UniCAP (Phadia,     Uppsala, Sweden) as well as for T cell analyses. (This part is optional upon agreement of the     parents).      Un-blinded food challenges will be performed under a physician's supervision in the clinical     research unit. Muffin and pizza will be administered in 4 equal portions over 1 hour.     Unheated milk will be administered in gradually increasing doses. Subjects will be monitored     throughout and for 2 to 4 hours after completion of the challenge. Challenges will be     discontinued at the first objective sign of a reaction or due to convincing persistent     subjective symptoms, and appropriate treatment will be initiated immediately.   "
116514|NCT01760824|"     Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major     causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop     peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection.     The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both     quadruple and sequential treatment regime has been proposed as the first-line empirical     regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime     remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability     of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as     empirical first and second line treatment.   "
116515|NCT01760811|"     To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment     followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for     advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501     and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and     cisplatin) with a similar stage of the disease.   "
116590|NCT01759836|"     Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate     cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer     recurrence has been investigated in several retrospective studies with inconsistent results.     The purpose of this study is to determine the impact of statin on biochemical recurrence     after radical prostatectomy for locally advanced prostate cancer.   "
116516|NCT01760798|"     Osteoporosis is characterized by decreased bone strength and it is prevalent among     postmenopausal women but also occurs in men and women with underlying conditions or major     risk factors associated with bone demineralization. Its chief clinical manifestations are     vertebral and hip fractures, although fractures can occur at any skeletal site.The World     Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5     standard deviations (SD) below the mean for young healthy adults of the same gender—also     referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young     normal range (a T-score of >1 SD below the mean) are defined as having low bone density     (osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures,     including hip fractures, among postmenopausal women occur in this group.      Teriparatide is one of the most effective treatment options for osteoporosis. But the cost of     teriparatide is prohibitively expensive and in countries like India with limited personal     resources of the individuals, its not a feasible option in the majority of the patients with     severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide     therapy in an open label non inferiority trial and if successful, the investigators     anticipate, the cost of treatment could be reduced considerably so that treatment becomes     more affordable to a larger number of patients. Also with weekly therapy, number of multiple     injections could be brought down.   "
116517|NCT01760785|"     Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or     eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective     lability following TBI. Observed clinically, the symptoms of poorly regulated affective     expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an     idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same     natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for     example. Instead, both symptoms and course appear more characteristic of the sustained affect     lability often observed following TBI. This observation suggests that TBI survivors represent     a patient group for whom treatment of neuropsychiatric symptoms following TBI may alleviate     both TBI-related affect lability and also heavy ethanol use by treating the condition that is     contextually related to excessive alcohol use.      Based on this concept of consequently treating AA/D through the management of post-TBI     affective lability, this study was conducted observing the efficacy of divalproex sodium on     the severity of affective lability and AA/D in persons suffering from a moderate TBI.     Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance     abuse problems. This drug has also shown positive results as an alternate medication to     benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the     progression of withdrawal symptoms in patients.   "
116518|NCT01760772|"     Individuals with obesity have an increased risk for heart disease and diabetes. There are     current drugs on the market that target the hormone, Glucagon like peptide-1 (GLP-1) to treat     diabetes. The investigators want to determine if targeting this hormone will also help people     with high cholesterol and triglycerides. In this study, the investigators are looking at the     role of GLP-1 in healthy subjects and subjects that have had bariatric surgery.   "
116519|NCT01760759|"     In this study, investigators propose to randomize 165 human immunodeficiency virus positive     patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care +     cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence     reminders and contingency management. In this latter condition, patients will earn     reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy     medication ingestion. Primary outcomes will include viral loads and self-report measures of     adherence, and effects will be evaluated both during the treatment period and throughout a     one-year follow-up. Investigators hypothesize that the cell phone reminder condition will     improve adherence relative to standard care, and the cell phone reminder plus contingency     management condition will have the best outcomes. Results from this study may have widespread     implications for the use of cell phones as a novel technology to improve initial adherence to     antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency     virus strains to the community.   "
116520|NCT01760746|"     PDR is a leading cause of irreversible vision loss in North America. This disease is caused     by the growth of abnormal blood vessels in the retina. These abnormal blood vessels can bleed     inside the eye, causing a vitreous hemorrhage (VH). Sometimes when patients have this     bleeding, a surgery called vitrectomy is required to remove the blood from within the eye. In     order to reduce complications during the surgery, most retina surgeons will inject Avastin     into the eye a few days before the surgery.      Avastin (bevacizumab) is currently not approved by Health Canada to treat any ocular disease.     Lucentis (ranibizumab) is approved by Health Canada as a treatment for age-related macular     degeneration, diabetic macular edema, and retinal venous occlusive disease. While Avastin is     not approved by Health Canada for the treatment of these diseases, the majority of retina     specialists around the world are now using Avastin off-label to treat these diseases. That     is because Avastin and Lucentis both tend to work equally well in these disease, but Avastin     is significantly cheaper. While Avastin and Lucentis are generally regarded to be equal,     there may be some differences between these two drugs that have not been discovered. The aim     of this study is to look for these differences.      Previous research by the investigators in this study has shown that injecting Avastin into     eyes causes increased inflammatory proteins to develop inside the eye. This increase in these     proteins was related to complications that developed after the vitrectomy surgery. Lucentis     may be associated with less of an increase in inflammatory proteins (and less complications).     The aim of this study will be to compare Avastin and Lucentis with respect to how they affect     inflammatory proteins in the eye, as well as the rate of complications during surgery.      Study participants will be divided into two arms (groups) of 30 subjects. Subjects will     receive Avastin or Lucentis a few days before vitrectomy surgery. The assignment will be     random and the study is double-masked. Masking is done so that the investigators can clearly     determine any differences between the 2 drugs.   "
116521|NCT01760733|"     Kidney transplantation has been shown to provide improved survival even in patients older     than 70 years of age. The purpose of the study is to determine whether kidney transplantation     provides any improvement of health related quality of life (HRQOL) in patients over the age     of 65 years. HRQOL wil be monitored using the Kidney Disease and Quality of Life     (KDQOL-SF)form. Patients will be recruited at the time of acceptance to the Norwegian     transplant wait list and followed every 6 months until transplantation. Thereafter a new form     will be completed after 10 weeks postv transplant, 6 months, 1 year, 3 years and 5 years. In     addition the study will explore the transplant candidates expectations in a qualitative study     design and explore the relationship between pre-transplant comorbidity, HRQOL and survival.   "
116591|NCT01759823|"     The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.   "
117412|NCT01749215|"     The goal of this project is to improve the treatment of veterans with co-occurring alcohol     dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct     a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.   "
116525|NCT01760681|"     The purpose of the study is to explore the efficacy and safety of H-Coil rTMS in comparison     to a sham H-Coil rTMS in older patients with treatment-resistant major depressive     disorder.Subjects will be randomized to receive H1-Coil rTMS or sham H1-Coil rTMS. The acute     treatment phase will last four weeks. Treatment is administered daily, 5 days per week (i.e.,     20 treatments). Depressive symptoms will be assessed using the HDRS-24. If subjects achieve     the pre-defined primary outcome criteria of remission (HDRS-24 score < 10 and 60% reduction     in symptoms) they will continue with twice weekly treatment for two more weeks to ensure the     durability of the remission. Subjects who do not achieve remission will exit the study after     the acute treatment phase of four weeks. The blind will not be broken to subjects until the     completion of the study   "
116526|NCT01760668|"     The study aim is:        1. To examine aortic tissue by light microscopy        2. To examine aortic tissue by electron microscopy        3. To study changes in the epigenome and transcriptome of the X chromosome specific to          aortic tissue.        4. To examine aortic tissue using biochemistry including proteomics.        5. To establish the karyotype of fibroblasts with standard chromosome examination on 10          meta-phases as well as by fluorescent in situ hybridization (FISH) with probes covering          the X and Y chromosome. Using the latter 200 meta-phases will be examined.      30 controls who did not die from aortic dissection or dilation will be recruited from The     Department of Forensic Medicine at Aarhus University Hospital.      The investigators will subject samples of aortic tissue from women undergoing prophylactic     aortic surgery due to either Marfan syndrome or bicuspid aortic valve to the same panel of     examinations (except karyotyping). Lastly the investigators will compare the results from the     three groups (Turner syndrome, Marfan syndrome and Bicuspid aortic valve).   "
116527|NCT01760655|"     This clinical trial studies reduced-intensity conditioning before donor stem cell transplant     in treating patients with high-risk hematologic malignancies. Giving low-doses of     chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the     growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. The donated stem cells may replace the patient's immune cells and help     destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the     donor's T cells (donor lymphocyte infusion) after the transplant may help increase this     effect.   "
116528|NCT01760642|"     Identification and evaluation of endogenous markers for the assessment of CYP3A activity in     female subjects using metabolomics   "
116529|NCT01760629|"     Whole body cooling improves survival with normal neurological outcome after neonatal     encephalopathy in high-income countries. However, cooling equipments used in the high-income     countries are expensive and unsuitable for wider use in low and middle-income countries     (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using     phase changing material in south India. Although cooling was provided, there were wide     temperature fluctuations.      Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in     administering effective and stable whole body cooling in encephalopathic infants.      Methods: After informed parental consent (and ethical approvals), we will administer 72 hours     of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants     (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical     College, over a six month period. To induce cooling, the infants will be kept on the cooling     mattress. Temperature will be continuously measured for 80 hours using a rectal probe     connected to a digital data logger.      The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for     which the temperature remains between 33 to 340C during the intended cooling period.   "
116530|NCT01760616|"     To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression     of hepatocarcinoma after non-radical hepatectomy.   "
116531|NCT01760603|"     Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous     fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.      This study is designed to determine the effectiveness and safety of ischia spinous fascia     fixation procedure for the treatment of pelvic organ prolapse stage III.      Patients enrolled into the study will be followed up for up to 3 years after surgery.     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before     and after surgery, patient satisfaction through quality of life and sexual function     questionnaires before and after surgery, and peri-operative complication rates will be     evaluated.   "
116532|NCT01760590|"     The purpose of this research is to compare the effects of two commonly used, safe, thoracic     spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in     individuals with nontraumatic cervical pain. The immediate effects of thoracic spine     mobilization have been shown to facilitate greater range of motion increases in the cervical     spine and greater pain decreases within a treatment session and on follow-up visits. There is     no research utilizing pain threshold perception as an objective outcome of these treatments.     Only one study compared the two treatment techniques and concluded that future research     should be completed which includes manual therapy for the thoracic spine. (Cleland 2007)   "
116533|NCT01760577|"     The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A     versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle     osteoarthritis.   "
116548|NCT01760382|"     Myocardial infarction (MI) outcomes strictly depend on the time to reponed the     infarct-related coronary artery. Networks have been activated in the last years in many     countries to achieve fast track access of patients with ST-elevation MI to hospital with h24     primary PCI availability or directly to Cath Labs. From 2011 a regional STEMI network have     been formally activated in Piedmont. The aim of our registry is to monitor the activity of     the STEMI network in the large suburban area of Novara (population of about 800.000     subjects).   "
116549|NCT01760369|"     The purpose of this study is to determine whether head rotation in prone positon affects     regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.   "
116625|NCT01759381|"     The purpose of this study is to evaluate the outcome of incisional negative pressure wound     therapy in preventing surgical site infections and wound complications (dehiscence) in     high-risk patients undergoing complex spinal surgery.   "
135030|NCT01517399|"     The purpose of this study is to determine the effects of tivantinib on the pharmacokinetics     of omeprazole, s-warfarin, caffein, midazolam, or digoxin in patients with cancer.   "
116535|NCT01760551|"     The American Medical Association's (AMA) Guides to the Evaluation of Permanent Impairment is     used to rate loss of function and determine compensation and ability to work after injury or     illness. The AMA Guides are used by many different systems to determine compensable levels of     impairment. However, there are few studies that evaluate reliability or construct validity.     (1) In the professional community there exists considerable controversy regarding the     accuracy and usefulness of the AMA Guides. (2,3) Commentaries have noted that the AMA Guides     do not provide a valid, reliable, evidence-based system for the rating of impairments. (4)     Some have argued that the impairment ratings do not reflect an individual's actual loss of     function and quality of life (QOL). The AMA guides 5th edition was based on loss of range of     motion (ROM). The new 6th edition of the AMA guides is based on diagnosis and inclusion of     functional outcomes assessments in the determination of impairment ratings. (5) In the     orthopaedic literature the use of patient-derived, objective outcome measures has     substantially expanded QOL instruments are categorized as general health or as     condition-specific questionnaires. The Medical Outcomes Study 36-Item Short Form (SF-36) is a     general health-based survey of quality of life. It has been validated and is used widely     across medical disciplines. (6) The SF-36 was constructed to survey health status in the     Medical Outcomes Study. It was designed for use in clinical practice and research, health     policy evaluations, and general population surveys. The SF-36 was constructed for     self-administration by persons 14 years of age and older, and for administration by a trained     interviewer in person or by telephone. (7) The SF-36 is perhaps the most widely used     health-related quality of life (HRQoL) survey instrument in the world today. It is comprised     of 36 items that assess eight health concepts: physical functioning, role limitations caused     by physical health problems, role limitations caused by emotional problems, social     functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.     Physical and mental health summary scores are also derived from the eight RAND-36 scales. (8)     The aim of this study is to determine the amount of correlation between the by orthopaedic     surgeon objectively calculated percentage of impairment scored by the American Medical     Association guides to the evaluation of permanent impairment and the by patient subjectively     indicated health-related quality of life scored by the SF-36.      Hypotheses: Because of and inclusion of functional outcomes assessments in the determination     of impairment ratings the AMA guide 6th edition will have a better correlation with the     SF-36. The 6th edition of the AMA guide is based on diagnosis en yield lower impairment     percentages than the AMA guide 5th edition that is based on loss of ROM. The SF-36 will have     better correlation with the impairment ratings for lower extremities injuries than for upper     extremities because it is less valid for the upper extremities.   "
116536|NCT01760538|"     The purpose of the study was to investigate the changes on heart rate variability, exercise     capacity, activities of daily living, and quality of life after aerobic exercise training in     cardiac transplant recipients.   "
116537|NCT01760525|"     This is a first in human phase I study of single agent CGM097 in patients with advanced solid     tumors who have progressed despite standard therapy or for whom no standard therapy exists.     The tumor must be characterized by p53wt status. The study consists of a dose escalation part     where patients will receive escalating doses of CGM097, and a dose expansion part in which     patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose     (RP2D). Each dose escalation step will be decided based on the recommendation from an     adaptive Bayesian logistic regression model (BLRM).   "
116538|NCT01760512|"     The purpose of this study is to gather clinical and economic evidence on the use of robotics     for bariatric surgery (gastric bypass).      This monocentric, randomized, single blind, controlled study will evaluate post-operative     pain, quality of life and appetite, post-operative complication incidence. It will also     provide information on direct and indirect costs of surgery.   "
116539|NCT01760499|"     The main purpose of this study is to find out more about how PV-10 works in melanoma tumors.     Researchers also want to find out if there are changes in the body's immune cells (cells that     fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors and     circulating in the blood.   "
116540|NCT01760486|"     The investigators have shown that adding an internet behavioral weight loss program to a     statewide campaign improves weight loss outcomes. However, our follow-up data suggest that     once the intervention is stopped, participants begin to experience weight regain. Thus, the     purpose of this project is extend this line of work and pilot test health coaches and     monetary incentives for weight loss maintenance. The investigators hypothesize that coaching     and incentives will improve longer-term weight outcomes.   "
116541|NCT01760473|"     The study is designed to compare the abuse liabilities of intranasal buprenorphine and     buprenorphine/naloxone in individuals who are physically dependent on sublingual     buprenorphine. The investigators hypothesize that the abuse liability of     buprenorphine/naloxone is lower than that of buprenorphine alone.   "
116542|NCT01760460|"     This study will evaluate the effects of anacetrapib (MK-0859) on low-density     lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with     dyslipidemia when added to an existing statin-modifying therapy.   "
116543|NCT01760447|"     The purpose of this study is to assess the safety and efficacy of the addition of sitagliptin     (administered as MK-0431A XR) compared with the addition of placebo to therapy with     extended-release metformin (metformin XR) for the treatment of type 2 diabetes mellitus     (T2DM) in pediatric participants with inadequate glycemic control on metformin therapy (alone     or in combination with insulin). The primary hypothesis is that the addition of sitagliptin     reduces hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of treatment.   "
116544|NCT01760434|"     Evaluate the long-term outcomes following operative and nonoperative treatment of childhood     scoliosis.   "
116545|NCT01760421|"     Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation     of thyroid gland and destroys thyroid tissue.      Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of     several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid     arthritis(RA) for more than one century.      The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment     of Hashimoto's thyroiditis.   "
116546|NCT01760408|"     The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) developed a Web-based     registry for nutrition care launched in early 2011, initially focusing on the home parenteral     nutrition (HPN) patient population. The purpose of Sustain is to collect information     regarding the patients and populations who require HPN in the United States, measure outcomes     associated with HPN, allow institutional benchmarking against the aggregate data, and publish     the findings to improve the quality of care for patients receiving HPN. The registry is open     to all sites (hospital and home based) who care for new or existing HPN patients.   "
116547|NCT01760395|"     Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable     complication rates, thousands of patients worldwide suffer from inguinal hernia surgery     complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives     reports from surgical complications. In this study, the database of FPIC is used to compare     the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.   "
117189|NCT01752010|"     The primary objective of this preliminary study is to compare the Tennant BioModulator with     Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for     the management of chronic pain among injured service members. The secondary objective is to     investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder     (PTSD) symptoms, or depression.   "
116550|NCT01760356|"     To search for suitable pharmacodynamic biomarkers, i.e., with high specificity for     calcineurin inhibition and most affected by inter-individual variability, our works aimed at     exploring the pharmacodynamics of CNI, the strength and variability of signal translation     along the calcineurin pathway, as well as the steps where sources of internal (genetic) or     external variability are the most influential.      In order to achieve this, we assessed simultaneously NFAT1 translocation into the nucleus of     peripheral blood mononuclear cells (PBMC) (NFTA1 being the main NAFT isoform in resting and     activated lymphocytes), the intracellular expression of IL-2 in CD3+, CD4+ and CD8+ T cell     subsets and the membrane expression of CD25 (IL-2Rα), a surface marker of T cells activation,     in T cells at large. A non-interventional clinical trial was set up in healthy volunteers,     patients registered on a liver transplantation waiting list (WLP) and liver transplant     recipients (LTR). A different question was addressed in each group: The healthy volunteer     study (n=35): explored TAC PD along the calcineurin pathway by exposing PBMC ex-vivo;     modelled signal translation along this cascade; examined the interindividual variability of     TAC PD parameters; and investigated the sources of the variability observed and their     contribution at each step of the calcineurin pathway. Furthermore, it allowed us to evaluate     the analytical variability of our techniques as well as the intra-individual variability of     TAC PD parameters. WLP (n=19) were enrolled to confirm in patients with liver diseases the     results obtained in healthy volunteers, as well as to test the potential influence of their     initial disease on the ex-vivo pharmacodynamics of TAC. The aims of the transversal study of     LTR on CNI (n=80) were to further explore the interindividual variability in the PD of CNI in     realistic clinical conditions, i.e. in situations of residual PD activities under tacrolimus     or cyclosporine exposure, and the potential pharmacogenetic (PG) sources of such variability.     The (still small) group of liver transplant patients (n=9) enrolled immediately before     transplantation and followed-up with serial monitoring along the first year     post-transplantation was intended to explore the relationships between CNI PD and clinical     responses.   "
116551|NCT01760343|"     A new formulation of Berinert (CSL830) is being investigated for the management of hereditary     angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose     of the new formulation of Berinert. This study will also look at the pharmacokinetics of     CSL830 relative to Berinert currently on the market.   "
116552|NCT01760330|"     This project is being used to assess the utility of intravenous acetaminophen in the     pediatric population undergoing palate repairs. This study is a prospective randomized double     blinded placebo controlled study. The investigators will have two arms, one group of patients     will receive intravenous acetaminophen and one group that will receive a placebo at a total     of four doses over 24 hours. The results of this study may affect the intraoperative     anesthetic management as well as post-operative surgical management of this specific patient     population. The goal is to determine the benefit of adding a non-opioid analgesic and     hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia     care unit as well as during the post-operative stay.   "
116553|NCT01760317|"     The purpose of this study is to compare two different approaches (midline and parasagittal)     during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of     concordant pressure paresthesia occurring during the LESI in determining outcome.      The investigators are planning to include 100 patients, undergoing LESI for radicular low     back pain. This will be single-blinded randomized study. Every patient will receive the same     medication we would use regardless of participating in the study. The patients will be     randomly assigned to one of two groups, based on the approach:        -  Group I (50 patients) - will get LESI using midline (MIL) approach.        -  Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.   "
116554|NCT01760304|"     To investigate whether Budesonide/Formoterol (Symbicort ®) therapy can improve heart function     at rest by decreasing lung hyperinflation in patients with COPD (Chronic Obstructive     Pulmonary Disease).   "
116555|NCT01760291|"     To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure     Technology   "
116556|NCT01760278|"     1. Culture conditions of developing embryos are highly controlled in the Embryoscope and          are monitored by Time-lapse videography to produce 3D images at different stages.This          cannot be done under conventional culture conditions.        2. The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the          Embryoscope,through latest software.        3. Embryoviewer also identifies embryos for transfer, freezing and to be discarded.   "
116557|NCT01760265|"     Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder.     It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous     APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol     and triglycerides.      As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia     predispose to the premature development of atherosclerosis.      However among this population there is heterogeneity in development of cardiovascular     complications and the determinants remain unclear actually.      The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis,     and identify its determinants.   "
116558|NCT01760252|"     The combination of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) may be better than     other combinations used to treat earlier stage pancreatic cancer patients with resectable     (able to be cut out), borderline resectable, and locally advanced pancreatic adenocarcinoma.     For subjects who can not obtain Capecitabine can be treated with 5-Fluorouracil (5-FU) along     with Oxaliplatin and Irinotecan. Though all of the drugs in this study have been approved by     the FDA, their combination is investigational. The purpose of this study is to evaluate the     effects of CAPOXIRI (good and bad) on you and your cancer.   "
116559|NCT01760239|"     The goal of this project is to improve detection and management of elevated blood pressure in     adolescents. It (a) uses electronic health record (EHR) technology to deliver     patient-specific clinical decision support (CDS) to providers at the point of care, (b)     assesses the impact of this intervention on identification and clinical care of hypertension     in adolescents, and (c) assesses the impact of the intervention on costs of care.   "
117413|NCT01749202|"     The purpose of this study is to assess the effect of stearidonic acid when used as a food     ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index in     men and women.   "
116594|NCT01759784|"     ALS is a debilitating disease with varied etiology characterized by rapidly progressive     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment     that has been found to improve survival but only to a modest extent. It lengthens survival by     several months, and may have a greater survival benefit for those with a bulbar onset. It     also extends the time before a person needs ventilation support.Stem cell transplantation is     a new hopeful way to improve the patients conditions and reduce the period of disabilities.   "
116560|NCT01760226|"     The subject is invited to take part in this research study because s/he has been diagnosed     with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or     Post-transplant Lymphoproliferative Disorder (PTLD).      In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists     are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R,     utilizes two major new strategies. First, the treatment approach utilizes continuous infusion     of chemotherapy over four days, instead of being administered over minutes or hours.     Secondly, the doses of some medications involved are increased or decreased based on how the     drugs affect the subject's ability to produce blood cells, which is used as a measure of how     rapidly the body is processing drugs.      Using this approach in adults, researchers have shown improved cure rates in these cancers.     Additionally, the harmful effects experienced by patients has been mild, with mucositis,     severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method     has never been used in children, and the effectiveness and side effects of this new method     are unknown in children.      The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment     of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been     shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.   "
116561|NCT01760213|"     The goal of the project is to overcome some of the common barriers to treatment amongst     recent survivors of traumatic events, by combining the world of evidence-based intervention     with that of modern Internet technology. Specifically, it aims to test the feasibility and     effectiveness of an Internet delivery of early-intervention trauma-focused cognitive     behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the     course of the study the following objectives will be achieved:        1. The development of an Internet-based Virtual Reality intervention for preventing PTSD          among patients who have recently experienced a traumatic event.        2. The evaluation of the feasibility of administering this intervention, and        3. The evaluation of the efficacy of this Internet based intervention in the prevention of          PTSD in recent trauma survivors.   "
116562|NCT01760200|"     Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting     stent (DES), but clinical results of different studies about DEB are not consistent.      Thus, we planned a meta-analysis to compare outcomes of DEB and DES in coronary artery     disease (CAD).   "
116563|NCT01760187|"     This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and     multiple ascending dose (MAD) study of orally administered lomitapide in healthy male     Japanese and Caucasian subjects with elevated LDL-C. The purpose for this study is to     evaluate the PK and PD of lomitapide in Japanese subjects as compared to Caucasian subjects.   "
116564|NCT01760174|"     This study compares the effect on postoperative pain of bolus administration of ropivacaine     in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural     catheters following open gynecologic surgery.The study is double blind. The hypothesis is     that the effect of the two modes of pain treatment are equal.   "
116565|NCT01760161|"     To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative     pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain     after the bilateral dual transversus abdominis plane block.   "
116566|NCT01760148|"     The purpose of this study is to validate the first round HCV early dynamics discovery within     a larger population.   "
116567|NCT01760135|"     After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic     aspects.   "
116568|NCT01760122|"     This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD,     Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient     evidences for the listed of the studied drug.   "
116569|NCT01760109|"     In the proposed study, the investigators plan to evaluate the efficacy and safety of     Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory     and urinary tract acute bacterial infection.   "
116570|NCT01760096|"     Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is     designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in     patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of     another bone marrow failure syndromes   "
116571|NCT01760083|"     CTOs are common among patients with angina, and are detected in around 20% of patients     undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI     practice on average. One of the reasons for the under-presentation of CTOs in PCI target     lesions is the lack of evidence-based medical data on treatment indications, and the     continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.      Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial     comparing PCI with optimal medical therapy in stable coronary disease did not show a     difference in mortality or myocardial infarction between the two treatment options. However,     CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of     PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether     PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic     burden has never been tested in a randomized controlled trial.      While there is compelling evidence from registry studies of a clinical and prognostic benefit     following successful PCI of CTO compared with PCI failure, there has been no randomized     controlled trial of contemporary PCI using drug-eluting stents versus optimal medical     therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related     to the extent of residual ischaemia and that PCI is more effective in reducing residual     ischaemia than optimal medical therapy alone. This confirms earlier retrospective data     suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe     (>20%) ischaemia.      Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to     OMT alone in improving health status at 12-month follow-up, and will be noninferior with     respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients     with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with     evidence of ischemia and viability in the territory subtended by the CTO   "
116572|NCT01760070|"     By combining injection and dissection capability together, O-type Hybrid knife could possibly     shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.   "
116593|NCT01759797|"     ALS is a debilitating disease with varied etiology characterized by rapidly progressive     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment     that has been found to improve survival but only to a modest extent. It lengthens survival by     several months, and may have a greater survival benefit for those with a bulbar onset. It     also extends the time before a person needs ventilation support.Stem cell transplantation is     a new hopeful way to improve the patients conditions and reduce the period of disabilities.   "
116573|NCT01760057|"     The proposed study is designed to develop and test the effectiveness of a novel web-based HIV     intervention to motivate HIV testing among men who have sex with men (MSM). The intervention     arm includes the delivery of videos tailored to the reasons MSM have for not getting tested     for HIV, as well as HIV testing motivational messages sent via mobile-phone text messaging,     e-mail or instant messaging. The intervention and assessments will be guided by the     Information-Motivation-Behavioral skills model, the Health Belief Model and the Stages of     Change theory. The control intervention will be a health promotion message (similar in     content to other Peruvian websites) with an invitation for free HIV testing. Testing will be     offered at the Via Libre and Epicentro clinic, and at a mobile unit whose location will be     determined based on participants' demand. The outcomes evaluated will be intention to get     tested and actual HIV testing among MSM of each of the trial arms.   "
116574|NCT01760044|"     Investigators are conducting research about oxygen levels in the body and whether it is     possible to use a device to measure oxygen in the body's tissues noninvasively, without blood     draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how     this device compares to standard measurements using blood from a catheter. This may help     treat patients who may not be getting enough oxygen to their body.   "
116575|NCT01760031|"     Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury     in patients undergoing elective coronary angiography. This study was designed to acquire     long-term data of initially randomized patients in the RenPro Trial.   "
116576|NCT01760018|"     Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely     used, and there are many clinical trials comparing these on various aspects of anesthesia.     However, there have not been studies comparing the quality of recovery from the different     methods of general anesthesia. In this study, the investigators compare the functional     recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40     questionnaire.   "
116577|NCT01760005|"     The purpose of this study is to assess the safety, tolerability, biomarker and cognitive     efficacy of investigational products in subjects who are known to have an Alzheimer's     disease-causing mutation by determining if treatment with the study drug slows the rate of     progression of cognitive impairment and improves disease-related biomarkers.   "
116578|NCT01759992|"     The global loss of muscle mass and strength associated with aging is a cause of functional     impairment and disability, particularly in the older elderly (>80 years). Respiratory     function can be severely compromised if there is a decrease of respiratory (RM) strength     complicated by the presence of comorbidities and physical immobility. In this context, the     need for supportive services involves the need for long-term care and consequently the     institutionalization.      Previous studies have shown that the increase of RM strength has positive healthy effects,     such as the increase in functional capacity, the decrease in RM fatigue, the decrease of     dyspnoea and the improvement of quality of life, both in healthy people and patients.     Therefore, specific RM training may be regarded as a beneficial alternative to improve RM     function, and thus prevent physical and clinical deterioration in this frail population.      Study hypothesis: The inspiratory muscle training (IMT) would improve respiratory muscle     strength and endurance, exercise capacity and quality of life in an elderly population, who     are unable to engage in general exercise conditioning.   "
116579|NCT01759979|"     Very large bile duct stones are difficult to remove. The prefered method involves an     endoscopic procedure known as endoscopic retrograde cholangiopancreatography (ERCP)performed     using a special side viewing endoscope. In the past small baskets passed through the scope     into the bile duct have been used to remove most stones using mechanical force.      Recently very small scopes known as cholangioscope have been introduced through the side     viewing endoscope directly into the bile duct. These cholangioscopes may be used to guide     laser therapy of bile duct stones. The investigators suspect that stone destruction using     cholangioscopy guided laser stone destruction may enable bile duct stones to be removed more     quickly and safely when added to the mechanical techniques.   "
116580|NCT01759966|"     The purpose of this prospective study is to investigate denervation (ie. surgical cutting of     autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant     recipients. More specifically, we focus on:        1. The physiological consequences of denervation, in particular its consequences for          clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and exercise          capacity. We hypothesize that denervation has negative consequences for all these          factors.        2. The pathological consequences of denervation and reinnervation, in particular its          association to acute rejection and coronary artery disease (cardiac allograft          vasculopathy, CAV). We hypothesize that reinnervation protects against acute rejection          and development of CAV        3. Donor and recipient factors associated with the reinnervation process. We hypothesize          that characteristics of the surgical procedure (such as aorta cross-clamp time) as well          as the rehabilitation process of the recipient (such as physical activity) impacts on          the reinnervation process.   "
116592|NCT01759810|"     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into     chronic and non-lethal, the survival rates and life quality can be improved by of control of     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells     (TSCs).      Brief Description:      The first line therapy of glioblastoma multiforme (GBM) involves allogeneic haploidentical     hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic lymphocytes (CTLs).      TCs and TSCs are isolated from GBM sample. Dendritic cells are isolated from peripheral blood     mononuclear cells and cultured. Tumor sample provides tumor specific antigens to prepare DV.     CTLs are obtained from peripheral blood after DV administrations. HSCs are harvested from     closely related donor after granulocyte-colony-stimulating factor (G-CSF) administration.      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six     months after the therapy completion, the efficiency is evaluated and the cohort demonstrating     efficiency continues the therapy, while cohort demonstrating no efficiency is transferred to     active comparator arm.      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with     modified proteome. Autologous HSCs are mobilized by G-CSF.      Carcinogenesis-free intracellular pathways of signal transduction able to respond to targeted     regulation of therapeutic cell systems with specific properties, are detected in TSCs using     complete transcriptome profiling of gene expression, proteome mapping and profiling of     proteins, bioinformation and mathematical analysis and mathematical modeling of protein     profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs regulation     are detected, as well as protein ligands able to regulate reproductive and proliferative     properties of TSCs.      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,     CTLs and autologous proteome-modified HSCs.      Autologous proteome-modified HSCs, DV and CTLs are administered as in the first line therapy.   "
116581|NCT01759953|"     Background: Physicians´ lack of knowledge contributes to underuse of insulin and poor     glycemic control in adults with diabetes mellitus (DM). Traditional continuing medical     education have limited efficacy, so new approaches are required.      Objective: We report the design of a trial to assess the educational efficacy of InsuOnline©,     a game for education of primary care physicians (PCPs) on initiation and adjustment of     insulin for the treatment of DM, which was designed to be: a) educationally adequate; and b)     self-motivating and attractive.      Methods: A multidisciplinary team, with endocrinologists, experts in medical education, and     programmers, was assembled for design and development of InsuOnline©, a serious game which     includes game elements and a well-defined, evidence-based curriculum of topics on insulin     therapy. The first step of our study will be usability and playability tests, with PCPs and     medical students, playing the game on a desktop. After that and further adjusts, we will     perform an unblinded randomized controlled trial, with PCPs who work in the city of Londrina,     to assess the educational validity of the game. A group of 64 PCPs will play InsuOnline© on     the web, and the control group, of 64 PCPs, will underwent traditional teaching activities     (lecture and group discussion). Knowledge on how to initiate and adjust insulin will be     assessed by a web-based multiple-choice questionnaire, and attitudes regarding     diabetes/insulin will be assessed by Diabetes Attitude Scale 3, at 3 time points: before,     immediately after, and 6 months after the intervention. Subjects´ general impressions on the     interventions will also be assessed by free-text questions. Software logs will be reviewed.   "
116582|NCT01759940|"     Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed to     offer advantages over general anesthesia in terms of monitoring neurological function during     cross-clamping of the carotid artery since, in conscious patients, speech, cerebration, and     motor power provide early measures of inadequate cerebral perfusion. Some studies also claim     lower shunting requirements, lower cardiovascular morbidity, and shorter hospital stay.      Traditionally, the common methods of cervical plexus block are termed 'deep' or     'superficial'. The deep block, as described by Moore or Winnie and colleagues, consists of     identifying the transverse processes of upper cervical vertebrae C2 - C4 and injecting local     anesthetic directly into the deep (prevertebral) cervical space. This may be achieved either     as separate injections or as a single injection. The superficial block incorporates a variety     of procedures. The simplest is a s.c. infiltration of local anesthetic along the posterior     border of sternocleidomastoid muscle by either the surgeon or the anesthetist.      An 'intermediate' block is one where the injecting needle pierces the investing fascia of the     neck, deep to the s.c. layer, but superficial to the deep cervical (prevertebral) fascia. It     is also possible to use a 'combined block', consisting of a deep injection and a superficial     or intermediate injection.      Practitioners may prefer one block to another, but no consensus exists on the efficacy of one     block when compared with another. However, it has been suggested that complications of the     technique are related to the deep injection and not the superficial (or intermediate)     injection. These complications include intrathecal or intravascular injection, respiratory     problems related to phrenic nerve paralysis, or local anaesthetic toxicity.      In this study the Influence of the concentration of the local anesthetic ropivacaine on the     quality of the intermediate cervical plexus block for carotid endarterectomy will be     evaluated. For this purpose two different concentrations of ropivacaine will be compared     (3,75% vs 7,5%). The primary endpoint of the study will be the quantity of the additional     needed local anesthetic to achieve adequate operative analgesia. Furthermore we will record     the frequency of the most common side effects as well as the patient satisfaction with a     standardized questionnaire.   "
116583|NCT01759927|"     The primary aim of this study is to investigate if and how a physical activity counselor can     offer an added value in exercise promotion in physically inactive employees. We will explore     if the physical activity counselor in the workplace setting can motivate sedentary employees     to engage into systematic participation in sports and/or exercise by means of a short term     coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching     process.   "
116584|NCT01759914|"     Ocular hypertension and glaucoma are eye conditions associated with abnormally high fluid     pressure in the eye (called intraocular pressure or IOP). If left untreated, the elevated IOP     may eventually cause damage to the nerve of the eye and potential impairment of vision.      The use of certain drugs has been identified as a risk factor for raised IOP, including     various forms of administration of corticosteroids. Corticosteroids can also lead to     cataract, which is clouding of the lens in the eye that can affect vision.      In this research study, we would like to find out whether the use of corticosteroids in our     dermatology clinic leads to raised IOP, in order to identify patients at risk and to allow     them to be more closely monitored than others. It is important to identify those patients who     have a corticosteroid-induced pressure rise early enough to prevent them from permanent     glaucomatous visual loss.   "
116585|NCT01759901|"     Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as     Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery.     However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to     post-operative liver dysfunction.      The investigators hypothesize that liver resection without the use of vascular inflow     occlusion (Pringle maneuver) is associated with lower postoperative complications rate.      The aim of this study is to evaluate whether elective open liver resection without vascular     inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical     complications in patient with hepatocellular carcinoma.      Eligible patients undergoing liver resection in the Prince of Wales Hospital will be     recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.   "
116586|NCT01759888|"     The primary objective of this protocol is to access the utility of 18F-DTBZ PET imaging as an     in vivo biomarker to monitor neurodegeneration of both PD mouse models and PD patients.     Secondary, the investigators will analyze progression rate of genetic-proving PARK8 and PARK6     patients who have homogeneous phenotype and genotype by 18F-DTBZ PET imaging.   "
116587|NCT01759875|"     The goal of this study is to evaluate the ability of a natural supplement (betaine     hydrochloride) to affect the absorption of atazanavir in healthy volunteers. The     investigators predict that betaine hydrochloride will increase the absorption of atazanavir     in volunteers pre-treated with proton-pump inhibitors (PPIs).   "
116588|NCT01759862|"     The aim of this study is to evaluate whether peri-transplant administration of a drug named     aminophylline to children undergoing a kidney transplant from deceased donors improves early     graft function and also projects on long term graft function.   "
116589|NCT01759849|"     This study examines in vitro blockade of signaling through the β-chain, on viability,     activation and differentiation of eosinophils and their progenitors collected in sputum,     blood and bone marrow samples pre and post-allergen challenge from mild atopic asthmatic     subjects.   "
116637|NCT01759225|"     A computerized registry of cardiovascular disease patients in a large health maintenance     organization in Israel. The registry is aimed to be used by health professionals to identify     cardiovascular disease patients and to follow the courses of their illnesses and risk     factors.   "
116595|NCT01759771|"     Vitamin D promotes the differentiation of prostate cancer cells and maintains the     differentiated phenotype of prostate epithelial cells. The results of the investigators'     clinical studies indicate that vitamin D3 supplementation results in a decrease of positive     cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators     hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at     4000 international units per day (intervention group) will show an improvement in the number     of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of     undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran     subjects taking placebo (control group).   "
116596|NCT01759758|"     The investigators are conducting a randomized clinical trial comparing two types of splints     for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet     inclusion criteria will be randomized to either Group A or B. Group A will be treated with     the conventional plaster ulnar gutter splint. Group B will be treated with a custom molded     thermoplastic hand-based splint. The thermoplastic splint will provide support of the     metacarpal but does not immobilize the patient's wrist or interphalangeal joints.      Hypothesis: Is plaster splint immobilization an equivalent treatment method to a custom made     thermoplastic splint for a fifth metacarpal neck fracture? Will one splint be tolerated     better than the other and will the compliance be different between the two groups?   "
116597|NCT01759745|"     Blepharospasm (BEB) is a focal dystonia characterized by forceful, involuntary contractions     of the orbicularis oculi muscle. (Jankovic et al 1983) Patients with BEB report task and     situation specific modulations of their symptoms. So called sensory tricks are actions that     minimize symptoms and include concentrating, talking, pulling on the eyelids, blowing air,     and applying pressure to the periocular or temple region. (Weiner 1984) Many patients     describe that other tasks/situations are exacerbate their symptoms specifically under bright     fluorescent lights and stress. (Burke 1984) Earlier studies showed that blink patterns differ     between BEB patients and control during rest, reading and talking.      In healthy subjects gaze evoked blinks are a physiologic phenomenon: initiation of gaze     shifts evoke a blink, blinks facilitate gaze shifts. (Evinger 1994) In healthy subjects     emotions and thoughts influence gaze shifts and blink rate. (Leal 2008, de Genaro 1988)     However, little is known about various task and emotion specific influences on symptoms of     BEB (e.g. expecting a gaze shift might worsen symptoms while driving a car).      Differences in emotion and gaze related blink patterns between patients and controls will     contribute to the understanding of the pathophysiology of BEB. This might offer new     therapeutic options, e.g. symptom modulation.      The investigators hypothesize that blink patterns, measured by duration and frequency of     pupillary occlusion differ between patients and control, when performing gaze shifts and     emotion related blink patterns, measured by duration and frequency of pupillary occlusion     differ between patients and controls.      The aim of this pilot trial is to assess differences in gaze evoked and emotion related blink     patterns between patients and controls. These differences might contribute to the     understanding of the pathophysiology of BEB.   "
116598|NCT01759732|"     Rationale: Fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body     irradiation (LD-TBI) may induce the engraftment cross the immunologic barrier in the setting     of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion     of CD3 cells may contribute to prevent developing severe acute graft versus host disease     (GVHD) in haploidentical transplantation.      Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell transplantation     with fixed dose of T cells after in vitro T cell depletion using CD3 monoclonal antibody for     children with acquired severe aplastic anemia   "
116599|NCT01759719|"     Recent reports have described cases of novel thin-strut coronary stent longitudinal     deformation during or after deployment and a biomechanical analysis have suggested increased     susceptibility for such a complication for the platinum chromium (PtCr) coronary stent     platforms . This analysis aims to assess the incidence of longitudinal stent deformation for     PtCr stents in a large single centre all-comers population using quantitative angiographic     analysis (QCA).   "
116600|NCT01759706|"     The purpose of this study is to assess the adherence to an enhanced recovery after surgery     (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in     patients undergoing pancreaticoduodenectomy (PD).   "
116601|NCT01759693|"     Platelets are blood cells that are important in coagulation of the blood. These cells have     recently been shown to play a role in a number of other biologic processes, for example     inflammation. In this study the investigators will determine the extent of platelet     activation in people suffering from common chronic skin inflammation-urticaria and allergic     dermatitis.   "
116602|NCT01759680|"     Tiredness, lack of motivation and low compliance can be observed in nursing home residents     during the practice of physical activity. Because exercises should not be too vigorous, whole     body vibration could potentially be an effective alternative.      The objective of this randomized controlled trial is to assess the impact of 3-month training     by whole body vibration on the risk of falls among nursing home residents.      Patients were randomized into two groups: the whole body vibration group which received 3     training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz     intensity and a control group with normal daily life for the whole study period.      The impact of this training on the risk of falls was assessed blindly by three tests: the     Tinetti Test, the Timed Up and Go test and a quantitative evaluation of a 10-second walk     performed with a tri-axial accelerometer.   "
116603|NCT01759667|"     Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese     patients. This loss is a result of several factors that go beyond the simple anatomical     abnormality of the gastrointestinal tract and may be the product of post-op energy     expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis (DIT) are     important components of energy expenditure and possible changes in them can perform an     important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously, we conducted     a cross-sectional study where we measured the RQ and DIT in pre and post-op RYGB patients,     which was published in the Surgery of Obesity and Related Diseases (SOARD) journal. The     objective of this study is to perform a prospective analysis of these same variables (RQ and     DIT), evaluating them in the same patients, when pre and postoperatively.   "
116622|NCT01759420|"     The purpose of this study is to assess the use of the medication ondansetron (zofran) in the     emergency department. There are studies of the ability of ondansetron to cause a prolongation     in the QT interval (a certain measurement on an EKG) in anesthesia and cancer patients, but     not on emergency department patients. This is an observational study where patients that are     going to receive the anti-nausea medicine ondansetron in the emergency department will have     an EKG performed every 2 minutes for 20 minutes to determine if the QT interval prolongs and     returns to normal in that time period. Any serious outcomes will be reported. There is     expected to be no adverse outcomes from this routinely used medication.   "
116604|NCT01759654|"     This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in non-elderly and     elderly subjects. All participates will receive one dose of vaccine (0.5 ml) by intramuscular     injection into the upper arm. Safety outcomes included immediate reactions at the time of     vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events     for 28 days, and serious adverse events. Sera prepared from blood samples will be collected     from each subject immediately prior to, and 28 days after vaccination. Anti-hemagglutinin     (HA) antibody titers will be determined using the WHO hemagglutination inhibition reference     technique. The central laboratory who is responsible for antibody titrations will not be     aware of the background of blood samples (e.g., pre- or post-serum), it is also called     observer-blinded. All participates will be followed, either by clinical visit or by telephone     contact, for 8 weeks after the vaccination for safety reasons.   "
116605|NCT01759641|"     The aim of the present work was to analyze the short-term variability of SO2 during     hemodialysis in sessions with and without hypotension to correlate the SO2 variability to     hemodynamic instability.   "
116606|NCT01759628|"     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver     function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and     anthropometric measurements (body mass index and waist circumference)in subjects with     non-alcoholic fatty liver disease.   "
116607|NCT01759615|"     This research is being conducted in preterm newborns with 'in utero' growth restriction due     to inadequate blood flow from the mother to the baby. These deprived babies adapt to the not     so conducive uterine environment by certain adjustments in blood supply to internal organs     thereby permitting as best as possible blood flow to brain heart etc., which are the vital     organs and whose adequate functioning is required for survival. In this bargain the gut     (intestines) gets poor blood supply and hence its appropriate functioning is jeopardized. In     the past such babies (after birth) were not fed for days together which compromised their     growth even further. Premature growth restricted' babies are at increased risk of further     growth faltering if not fed in time as also to a condition called 'Necrotising enterocolitis'     if fed liberally like other healthy neonates, characterized by abdominal distension, blood in     stools and inability to feed for much longer duration thereby further affecting growth. This     study is evaluating a feeding schedule of early versus late initiation of feeding to arrive     at the best time to feed such doubly jeopardized premature growth restricted babies to avert     the above mentioned consequences.      No study has been conducted in India to confirm the aforementioned fact and hence this study     has been planned. The information learned from this study will help us to feed these small     premature as well as growth restricted babies with AREDF better which will go a long way in     the care of such preterm growth restricted newborns.   "
116608|NCT01759602|"     The overall objective is to evaluate the tolerability/safety and preliminary efficacy of     CINRYZE® (C1 esterase inhibitor [human]) as add-on therapy for treatment of acute optic     neuritis and/or transverse myelitis in NMO and NMOSD.      Primary Objective: To evaluate the safety and tolerability of 3-5 doses of 1000 - 2000 Units     intravenous CINRYZE in NMO/NMOSD patients during an acute exacerbation.      Secondary Objectives:        -  To determine the frequency of adverse events with CINRYZE in this patient population.        -  To determine the effect of CINRYZE on NMO clinical scores (Expanded Disability Status          Scale and Low Contrast Visual Acuity).        -  To compare the change in MRI lesion size and extent following a course of CINRYZE.   "
116609|NCT01759589|"     To compare the effectiveness of three different anesthetic regimens (propofol,     remifentanil-propofol and sevoflurane in ECT.   "
116610|NCT01759576|"     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the     drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin     (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal     kidney function and non-diabetic volunteers with varying degrees of kidney impairment     (including volunteers with end-stage renal disease requiring hemodialysis).   "
116611|NCT01759563|"     Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide     targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to     obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without     delaying the procedure of valve implantation.   "
116612|NCT01759550|"     The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol     Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and     gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic     value of using LigaSure in gastric surgeries will be appraised.      In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or     gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled     with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects     undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation)     procedure at Durham Regional Hospital will be recruited.      Data Analysis will be performed using the data collected in the software program titled     MetaBar at Duke University Medical Center. Categorical variables will be summarized as     proportions for each category; continuous measures will be summarized by mean and standard     deviation or median and range as appropriated for the data distribution. Procedure-related     risks are those typically associated with gastric procedures and general anesthesia including     intra-operative bleeding, infection, and injury to surrounding organs and structures. Device     related risks include those normally associated with the use of electrosurgery including     intra-operative bleeding, unintended tissue burns, electrical shock, and electrical     stimulation of muscles and nerves.   "
116613|NCT01759537|"     The purpose of this study is to test two standard of care techniques of placing dental     implants, and to compare how people's bones and gums respond to two different depths at which     implants are placed.   "
116638|NCT01759212|"     The aim of the study is to investigate safety and efficacy of intramyocardial implantation of     allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy     undergoing left ventricular assist device implantation.   "
116639|NCT01759199|"     The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker of     exercise tolerance evolution during a pulmonary rehabilitation program in people with all     stages of severity of Chronic Obstructive Pulmonary Disease (COPD).   "
116614|NCT01759524|"     Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is     predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone     produces analgesia. When administered centrally its effects are predominantly due to its     alpha 2 activity. When administered peripherally it prolongs the analgesia through its     vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another     possibility is that it prolongs analgesia of peripheral nerve blocks due to a     hyperpolarisation current .Clonidine has been used successfully both for upper and lower limb     blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A major     concern with the lower limb blocks is the risk of falls associated with prolonged motor     blockade during early mobilisation. Clonidine has been shown to intensify and prolong the     motor blockade produced by long acting local anaesthetics. Lidocaine when used in combination     with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses of clonidine     are associated with longer analgesia but with more side effects. Clonidine in a dose of 90     mcg administered with local anaesthetics can produce analgesia for up to 10 hrs with minimal     side effects. The aim of this study is to compare lidocaine 2% + clonidine 1.5mcg/kg with     bupivacaine alone in terms of block selectivity for combined sciatic -saphenous nerve block     in patients under going semi elective foot/ankle procedures.   "
116615|NCT01759511|"     The primary objective of this study is to evaluate the long term safety and tolerability of     simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had     previously participated in Gilead clinical trial AB0024-201.   "
116616|NCT01759498|"     Since hydrogen therapy in humans seems to be beneficial for treating inflammation,     ischemia-reperfusion injury and oxidative stress, it seems plausible to evaluate the effects     of exogenously administered hydrogen as an element of instant management of sport-related     soft tissue injuries (e.g. muscle sprain, ligament strain, tendonitis, contusion). The main     aim of the present study will be to examine the effects of two-week hydrogen-rich oral and     topical administration on the inflammation, recovery and functional abilities in competitive     male and female athletes after acute soft-tissue injury. During the season 2012/2013 (from     February to June) subjects (36 professional athletes) will be recruited and examined by     certified sports medicine specialist in the out-patient clinics of the Center for Health,     Exercise and Sport Sciences in the first 24 hours after the sport-related soft tissue injury     was sustained. The subjects will be allocated to a double-blind design to three randomly     assigned trials. During the period of 2 weeks subjects in the placebo group (PLA) will     receive traditional treatment protocol after the soft-tissue injury, consisting of RICE     protocol during the first 48 h and sub-acute protocol thereafter. Subjects in the first     experimental group will follow the above procedures with additional administration of oral     hydrogen-rich capsules (4 capsules three times per day) throughout the study. Subjects in the     second experimental group will follow the procedures of first experimental group with     additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout     the study. Participants will be evaluated at the beginning of the study (e.g. at the time of     the injury report), after 7 and 14 days after baseline testing for: a) serum C-reactive     protein, plasma viscosity and interleukin 6 level, b) pain intensity during rest and walking,     c) degree of joint swelling, d) passive joint flexibility, and, e) subjective side-effects.     The investigators expect that the administration of hydrogen will significantly improve     inflammation outcomes (e.g. decrease in serum C-reactive protein) as compared to the placebo,     with topical hydrogen administration will additionally improve post-injury recovery outcomes     (e.g. pain intensity, degree of swelling). These results could support the hypothesis that     hydrogen-rich intervention may be included as an element of immediate treatment for     sport-related soft tissue injuries.   "
116617|NCT01759485|"     Background: Despite improvements in medications, treatment delivery and rehabilitation,     schizophrenia outcomes remain suboptimal. There are a proportion of 30-40%     treatment-resistant schizophrenia patients. Multiple lines of evidence suggest that vitamin D     is a neuro-active steroid that acts on brain development, leading to alterations in brain     neurochemistry and adult brain function. Early deficiencies have been linked with     neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been     associated with adverse brain outcomes, including Parkinson's disease, Alzheimer's disease,     depression and cognitive decline. Ecological studies support a potential role for vitamin D     in schizophrenia. These data include studies that have explored the association between     schizophrenia and winter/spring birth and also the apparent increased incidence and     prevalence of schizophrenia at higher latitudes. Objective: To evaluate the effect of     vitamin-D supplementation on the mental state of clozapine-treated chronic schizophrenia     patients, and the relation of disease severity to serum vitamin D levels. Methods: the     investigators will use a prospective, interventional, longitudinal, double blinded,     placebo-controlled, randomized design. The investigators will recruit 50 clozapine-treated     chronic schizophrenia patients, with low level of serum vitamin-D, that will be randomly     assigned (1:1 ratio) to receive either weekly oral drops of vitamin D (Cholecalciferol) or     oral drops of placebo for 8 weeks follow-up. Repeated assessments will include: clinical     severity scales (PANSS, CGI), side effects (SAS, BARS, clozapine side effects), cognitive     (MoCA), metabolic parameters and laboratory data. Patients who were assigned to placebo will     be supplemented with vitamin D after the 8 weeks period, and then will be assessed again with     the same protocol of vitamin D treated patients. All participants will be assessed again     after 24 weeks after vitamin D initiation. Analysis: the investigators will use on-way ANOVA     with repeated measures for comparison of vitamin D and control groups. The investigators will     apply intention to treat and LOCF.   "
116618|NCT01759472|"     To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of     anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a     specific sensitive to leukotriene population of asthma.      Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in     leukotriene-sensitive group than leukotriene-insensitive group.   "
116619|NCT01759459|"     The purpose of this study is to compare the pain level felt by patients when receiving     placement of a peripheral intravenous catheter (IV line) following the administration of a     local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and     bacteriostatic normal saline. Lidocaine is commonly used as a premedication for reducing the     pain upon insertion of peripheral IV lines. However, due to its acidic nature, the lidocaine     itself may cause pain upon administration. To help counter this discomfort, pharmacies can     buffer the lidocaine using sodium bicarbonate, which increases the pH to a neutral value,     resulting in less pain. Bacteriostatic normal saline has also been used for local anesthesia     with peripheral IV placement, particularly in patients with a lidocaine allergy, as it     contains benzyl alcohol which acts as a local anesthetic.      There are minimal reports from the literature that directly compare patient reported pain of     all three agents to one another, although studies do exist that have compared buffered     lidocaine versus lidocaine and buffered lidocaine versus bacteriostatic normal saline. To     address this comparison gap, the following research questions need to be asked: which     anesthetic agent is the superior premedication for reducing the amount of pain upon     administration of the local anesthetic itself and for the pain associated with the peripheral     insertion of the catheter? The hypothesis of the investigators is that there is not a     significant difference in the degree of pain scales between the anesthetic agents to justify     the pharmacoeconomic costs associated with compounding buffered lidocaine.      The primary outcome measured in this study will be the level of pain reported by the patient     upon administration of the local anesthetic and upon insertion of the peripheral intravenous     catheter. A secondary outcome includes a pharmacoeconomic analysis that will look     specifically at the cost-savings of using one agent over the other and will take into account     the daily time allocated to pharmacy technicians and pharmacists for compounding and     verifying buffered lidocaine.   "
116620|NCT01759446|"     To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and     acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when     crushed and administered intranasally to non dependent, recreational opioid users.   "
116621|NCT01759433|"     The reference intervals for Sonoclot Analysis may be different between Chinese and American.     So far, no reference interval has been established in Chinese for Sonoclot Analysis. This     study is going to establish the first Chinese reference intervals for Sonoclot Analysis and     test whether they are different from American reference intervals.   "
118989|NCT01728454|"     The primary objective of this study is to determine the safety and efficacy of two oral doses     of Proellex administered to premenopausal women with pelvic pain associated with     endometriosis confirmed within the last seven years and using prescription analgesics for     symptomatic pain.   "
116627|NCT01759355|"     This is a two arm, single center feasibility study of 20 patients with non-metastatic     cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects     will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.   "
116628|NCT01759342|"     This protocol was designed to assess if when subjects with CF are admitted to the hospital     for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity     aerobic, resistance, flexibility and balance exercises) was superior to our usual care     intervention (30 min/day of self selected mode and intensity of exercise) in improving     aerobic capacity, muscle strength/power, flexibility and balance.   "
116629|NCT01759329|"     Epidemiological studies have indicated a positive health impact of coffee. Nevertheless,     intervention studies testing the effect of daily coffee consumption over a longer period are     lacking so far. Moreover, there is a lack of knowledge about the properties of different     coffees and their influence on weight development. Therefore, we tested the effect of two     coffees differing in their alkyl pyridine content over a period of 3 months on weight     development.   "
116630|NCT01759316|"     Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress     and lung injury caused by mechanical ventilation.   "
116631|NCT01759303|"     The purpose of this study is to determine the 4-month Progression-Free Survival (PFS), with     demonstrated increase in tumor doubling time, of eligible subjects treated with pazopanib     according to RECIST version 1.1 guidelines.   "
116632|NCT01759290|"     ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:        -  Provide ongoing post-market surveillance for documentation of safety, performance and          clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily          percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU,          on-label use).        -  To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or          overlapping use (bailout, optimization of long lesion treatment) for the treatment of          patients with ischemic heart disease caused by de novo native coronary artery lesion(s)        -  Collect additional information (e.g. acute success) to evaluate handling and          implantation of Absorb BVS by physicians under a wide range of commercial use conditions          and following routine clinical practice.   "
116633|NCT01759277|"     Patients typically experience moderate-to-severe pain following knee arthroplasty that is     usually treated with a combination of oral and intravenous analgesics and enhanced by     continuous peripheral nerve blocks. There are currently two locations to place a perineural     catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an     adductor canal catheter. Both have been demonstrated to be effective following knee     arthroplasty. However, it remains unknown if one location is superior to the other; or, more     accurately, what the relative benefits are to each technique.      While femoral CPNB has many benefits, one of the challenges of using this technique is that     there is a decrease in quadriceps muscle strength which can be a limiting factor for     rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis.     This block may lessen block-induced quadriceps weakness following knee arthroplasty compared     with a femoral infusion.      The investigators hypothesize that compared with femoral perineural local anesthetic     infusion, an adductor canal infusion is associated with a shorter time until four discharge     criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3)     ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting     position without another's assistance.   "
116634|NCT01759264|"     The objective of this observational study was to assess changes in fecal calprotectin levels     and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's     Disease who were treated with adalimumab.   "
116635|NCT01759251|"     The purposes of this international post-marketing observational program is to investigate     effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of     vestibular vertigo after treatment discontinuation in population of Russia and Ukraine     outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory     analyses of results from both participating countries may be expected to provide insights     about the subjective circumstances of vestibular vertigo patients in a wider than usual range     of gender, underlying ICD-10 diagnosis, national and cultural situations.   "
116636|NCT01759238|"     This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in     oligometastatic patients neither being progressive nor resectable after chemotherapy.   "
123962|NCT01663220|"     A multi-year clinical study to improve tools for measuring the function of insulin-producing     beta cells in people with type 2 diabetes mellitus.   "
116640|NCT01759186|"     The investigators will study the biologic and chemical differences that cause the greater     incidence, and severity of asthma in women as compared to men. Severe asthma affects boys     more than girls, while severe asthma in adults is predominantly a disease of women. The     investigators aim to identify the processes that occur in the body that are behind the onset     of severe asthma in young women during the teenage years, and the resolution of severe asthma     in boys. To further evaluate gender influences on asthma, asthmatic women at different stages     of their menstrual cycle (period) will be also studied. The investigators aim to use     biomarkers to develop testing procedures that will identify different types or     characteristics of asthma in men and women; and to follow patients over time to uncover     relevant clinical outcomes of biomarkers. The investigators anticipate that they will 1)     develop clinically relevant tests to identify unique types or characteristics of asthma and     severe asthma; 2) determine outcomes over time of biochemically-defined types of asthma; and     3) identify the reasons for why adult women are affected more than men with severe asthma.   "
116664|NCT01758874|"     PAD is caused by an increased flow resistance in atherosclerotic ischemic limbs. The     investigators hypothesize that reducing blood viscosity (through controlled phlebotomy),     thereby increasing the deformability of red blood cells, should reduce the flow resistance     and improve tissue perfusion leading to improved clinical function and a reduction in     symptoms.      Preliminary data demonstrates that phlebotomy causes a measurable change in blood viscosity     as measured by the home-made rheologic method.      To evaluate the effectiveness of changes in blood viscosity, obtained through controlled     phlebotomy, as a therapy to improve functional status associated with atherosclerotic     ischemic limbs in pre-amputation patients.   "
116641|NCT01759173|"     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which     are temporal reflections of the neural mass electrical activity of cells in specific regions     of the brain that occur in response to stimuli, may offer such a method, as they provide both     a noninvasive and portable measure of brain function. The ERPs provide excellent temporal     information, but spatial resolution for ERPs has traditionally been limited. However, by     using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is     improved significantly. The paradigm for the current study will combine neurophysiological     knowledge with mathematical signal processing and pattern recognition methods (BNA™) to     temporally and spatially map brain function, connectivity and synchronization.      The proposed study will provide additional evidence for the utility and contribution of the     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain     functional connectivity associated with concussion) in concussion management.   "
116642|NCT01759160|"     To compare the hemodynamic changes during anesthesia induction between Marsh and Schnider     plasma TCI models. We put forward a hypothesis that, if one TCI model is associated with much     more prominent vasodilation effect or cardiac depression, a more sharp decrease in mean     arterial pressure, systemic vascular resistance , central venous return or stroke volume     would be observed.   "
116643|NCT01759147|"     There are many surgical methods available for the treatment of patients with     acromioclavicular dislocations. No single method has yet proven to be superior to the others.      The purpose of this study is to evaluate the clinical outcome and complications associated     with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a     single transclavicle transcoracoid bone tunnel. The implantation is performed using an     endobutton system that augments the repair with fibrewires.      The investigators will prospecitvely follow 30 patients enrolled in the study.      The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will     result in good clinical outcome and few complications.   "
116644|NCT01759134|"     The objective of this study is to compare the post-discharge growth of preterm infants fed     with 2 different post discharge formulas.   "
116645|NCT01759121|"     This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic     efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL     endpoint management function for severe non-proliferative diabetic retinopathy.   "
116646|NCT01759108|"     Xerostomia is a major distressing symptom in Sjőgren's syndrome(SS). Preclinical and clinical     studies have demonstrated an increase in saliva volume following rebamipide administration.We     thus hypothesize that rebamipide may be efficacious in the treatment of dry mouth symptoms     related to Sjőgren's syndrome.We will recruit SS patients in a randomized placebo-controlled     trial for 12 weeks. The main outcome measure that will concern us is patient-assessed     improvement of dry mouth symptoms and increase in salivary secretion Safety and efficacy was     assessed at each visit.   "
116647|NCT01759095|"     The purpose of this study is to determine the benefit of patients using a multidrug blister     packs after discharged from an university hospital to their homes.   "
116648|NCT01759082|"     Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with     moving erythrocytes to visualize perfusion in the microcirculatory system.      The new device to be used in this study have been adapted specifically for the application,     facilitating its use in clinic. It has been designed to take a standard white light image of     the area under inspection simultaneously with the perfusion image to facilitate clinical     assessment.      Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin     found in approximately 0.3% of children. They are commonly found on the face and neck and may     cause serious psychological consequences.      Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very     effective in PWS in closing the blood vessels and diminishing therefore the redness of the     skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.      Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical     inspection and digital photography.      By measuring the activity and intensity of the microcirculation present in and under the     skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser     (PDL) treatment for port-wine stains.   "
116662|NCT01758900|"     Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small     intestine.Initial reports indicated that CO2 was effective during the colonoscopy     ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy)     examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.   "
116663|NCT01758887|"     -  Would be there any difference in dopamine synthesis between remitted clinical high risk          subjects for psychosis and healthy control?        -  What would happen to dopamine synthesis after antipsychotic discontinuation in clinical          high risk subjects for psychosis?        -  What about the dopamine synthesis in recurred clinical high risk subjects for psychosis          after the discontinuation?   "
117745|NCT01744730|"     The purpose of this study is to better understand how clindamycin works in children who fall     in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The     results of the study will help better understand if children in higher BMI ranges process the     medication differently and whether dosing should be adjusted in these children.   "
116665|NCT01758861|"     Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary     bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection     against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the     present study was to investigate the effect of a single preoperative bolus of EPO on the     incidence of AKI following complex valvular heart surgery in a randomized, controlled and     double-blind trial.   "
116679|NCT01758679|"     This clinical trial is designed to provide one kind of modalities for preventing the     recurrence and metastasis of PLC. If the expected therapeutic efficacy is achieved, it shall     contribute actively to boosting the therapeutic level of PLC, prolonging its recurrent time     and enhancing its overall survival. And it may also raise the clinical recognition of this     technology, promote its clinical applications and generate excellent social reputations and     economic returns.   "
116649|NCT01759069|"     An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The     overall success rate for this treatment is high; 97% of the treated teeth are retained in the     oral cavity after 8 years (Salehrabi & Rotstein, 2004). However, there are teeth that have a     persistent granuloma because of various reasons and need endodontic retreatment or apical     surgery. Overall results in literature for an endodontic retreatment show a success rate of     77%-89% (Ng, Mann, & Gulabivala, 2008; Salehrabi & Rotstein, 2010), the results of apical     surgery are more or less similar (von Arx, 2005). Which of the two methods is preferred for     failed root canal treatments is dependant on a variety of reasons. (For example an amount of     gutta-percha outside the apex of the root is better corrected by apical surgery. Persistent     infection as a result of insufficient gutta-percha amounts in a treated root is best treated     with an endodontic retreatment.) The overall results in apical surgery have increased the     past years due to better preparation of the apical end of the root by the use of an     ultrasonic device (de Lange, Putters, Baas, & van Ingen, 2007) and new materials that are     used for filling of the rootend e.g. MTA (von Arx, Hanni, & Jensen, 2010)      Objective of the study:      The objective of this study is to assess whether or not apical surgery that is carried out     with the help of a microscope has a higher success rate than apical surgery without the use     of a microscope. No RCT is found in present literature (Del Fabbro, Taschieri, Lodi, Banfi, &     Weinstein, 2009).   "
116650|NCT01759056|"     The purpose of this study is to evaluate the safety and tolerability as well as the     pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with     active ulcerative colitis.   "
116651|NCT01759043|"     The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a     single guiding catheter for left and right coronary angiography and intervention in patients     with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time     and Cath Lab door to balloon(C2B) time when compared with traditional approach which first     underwent coronary angiography with diagnostic catheter followed by guiding catheter     selection for intervention.   "
116652|NCT01759030|"     The purpose of this study is to prove that efficacy, safety and immunogenicity of BCD-020 is     equivalent to MabThera when used in combination with methotrexate for the treatment of     patient with rheumatoid arthritis   "
116653|NCT01759017|"     The costs and potential complications (side effects) of therapies currently used to treat     Crohn's disease could be reduced if a non-invasive test existed that determined which     therapies benefit patients and which do not. A non-invasive test is a test that does not     involve cutting or entering the skin. Currently, once therapies are prescribed, doctors rely     solely on clinical parameters to gauge whether the therapies are helpful. This includes     evaluation of overall general well-being, abdominal pain, and number of liquid stools per     day. There is no established and reliable non-invasive test that can predict whether a person     is responding to therapy early in the course of treatment when these evaluations may be     inconclusive.      During this research study we will look for changes in sugar metabolism on low-dose PET/CT     before and 2 weeks after the first infusion of infliximab therapy. This is to find out if     these changes can predict clinical response and steroid-free remission at two, six and 12     months, in patients with Crohn's disease.   "
116654|NCT01759004|"     The diagnosis of lipoedema and obesity are often mixed up, unclear stated and often there is     a misdiagnosis. The primary aim is to investigate whether there is a difference in muscle     strength between women with lipedema and women with obesity. The secondary aim is to     investigate whether there is a difference in physical fitness between women with lipedema and     women with obesity.   "
116655|NCT01758991|"     In the acute phase of stroke, dysphagia (difficulty/inability to swallow) is a common problem     that can have serious consequences such as aspiration pneumonia, increased lenght of     hospitalisation, and death. It would be interesting to enhance the therapeutic effect of     swallowing retraining by means on non-invasive brain stimulation such as transcranial direct     current stimulation (tDCS).      Hypothesis: during the acute phase of stroke, applying tDCS over the brain during the     revalidation and/or supervised feeding improves dysphagia significantly when compared to sham     tDCS.   "
116656|NCT01758978|"     The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone     bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release     tablet.   "
116657|NCT01758965|"     The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to     H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors   "
116658|NCT01758952|"     Stroke is an important cause of perioperative morbidity and mortality, particularly in     patients > 60 years. In cardiac, neurological and carotid surgery the incidence is known to     be high (2.2-5.2%). However, little is known regarding perioperative stroke following other     types of surgery including general, urological, orthopedic, thoracic and gynecological     procedures. We therefore propose to undertake a multicenter, observational cohort study, to     determine the current incidence of, the risk factors for, and outcome associated with     perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.   "
116659|NCT01758939|"     Retrospective prospective cohort study aimed at Assessing the predictors to the response to     the antiviral combined therapy with pegylated Interferon (Both types: Alfa 2 A and Alfa 2 B)     in hepatitis C virus infected Egyptian patients.   "
116660|NCT01758926|"     The study aims to:        1. To determine the relationship between inflammatory activities and epithelial gaps in IBD          by CLE and evaluate epithelial gaps healing via dexamethasone treatment.        2. To demonstrated the alteration of local barrier function in IBD using CLE.   "
116661|NCT01758913|"     Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used     for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as     indomethacin but has less adverse effects on renal function, cerebral blood flow and     mesenteric blood flow.1-7 There are, however, very few studies being done specifically on     extremely low birth weight (ELBW) infant < 1000 g. This group of infants has immature kidney     and often has poor response to PG inhibitors and has high mortality and morbidity. We     hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be     different between indomethacin and ibuprofen.   "
118990|NCT01728441|"     Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting     balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.   "
116666|NCT01758848|"     Overactive bladder is a syndrome of symptoms. The core symptom is urgency with/without urge     incontinence, frequency, nocturia. The prevalence of overactive bladder increased with age.     The elderly is increasing with time, so the people who suffering from overactive bladder is     also increasing. Research related to overactive bladder in the field of physical therapy is     remained needed. The purposes of this study are to investigate the application of physical     therapy to women with overactive bladder, emphasizing on the effect of voluntary muscle     contraction for urgency inhibition, including the urodynamic study and clinical study.      There are three stages in this study. In the first stage, we are going to develop a specific     health-related quality of life questionnaire for urinary incontinence in Taiwan version. One     hundred and fifty women with urinary incontinence and fifty healthy women without lower     urinary tract symptom will be recruited in the first year to investigate the reliability and     validity of the questionnaire. The Short-Form 36, Chinese version, will be used as gold     standard for validity. Fifty women with urgency will be recruited in the second stage to test     the effect of muscle active contraction strategies to inhibit detrusor pressure and urgency.     The three muscle active contraction strategies include pelvic floor muscle strong     contraction, pelvic floor muscle tonic contraction, and transversus abdominis tonic     contraction. The outcome variables including detrusor pressure of the urodynamic parameter     and self-reported urgency score. Simultaneous image record by abdominal ultrasound during the     urodynamic examination will be used to ensure the accuracy of muscle action. The predictors     of success of strategy from the result of the second year will be used to stratify the     patients in the third stage. Eighty women with urgency will be recruited in the final stage     to examine the clinical effect of strategy for urgency inhibition.   "
116667|NCT01758835|"     PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress     negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable     splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks     and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections.     Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in     follow up-visits 6 and 12 weeks and 1 and 2 year.   "
116668|NCT01758822|"     The purpose of this study is to evaluate the role of endotracheal suction on the occurrence     of meconium aspiration syndrome in depressed meconium stained babies. Meconium aspiration     syndrome (MAS) is believed to result from aspiration of meconium and consequent chemical     pneumonitis. Meconium can be aspirated into the lungs in the womb as well. Meconium in the     distal airways is not accessible to endotracheal (ET) suction which clears only the windpipe.     Furthermore there is growing evidence in support of asphyxia-hypoxia-acidosis in the     causation of lung disease. Moreover, in the absence of a clear role of ET suction in     depressed meconium stained newborns, critical time could be lost in assessment, intubation     and ET suction (range: 30 seconds to 1 min) which might delay the definitive step of     ventilation for resuscitation of such babies that can potentially affect the outcome     adversely.The utility or futility of endotracheal suction in preventing MAS in depressed     meconium stained neonates has not been systematically studied and there is inadequate     information in literature in favor or against this practice.Thus this study is an attempt to     evaluate the effect of endotracheal suction on the occurrence of MAS in depressed full term     neonates born through meconium stained amniotic fluid (MSAF).   "
116669|NCT01758809|"     The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a     better alternative pain control modality than the conventional intravenous patient controlled     analgesia.   "
116670|NCT01758796|"     The purpose of the study is to find the optimal treatment for ER-Stress positive Weber-B     unimallaolar ankle fractures.   "
116671|NCT01758783|"     Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral     nutrition support on nutritional status, immunologic function and intestinal permeability of     patients with chronic radiation intestinal injury.      Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group     and glutamine-enriched TPN group. The patients were administered total parenteral nutrition     for at least four weeks (two weeks pre-operation and two weeks post-operation). The     nutritional status, immunologic function, plasma concentration of glutamine and intestinal     permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2     weeks post-operation. Nutrition status was determined the plasma concentrations of     hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were     measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to     CD8+T cells ( CD4 +/CD8 +) was calculated， and serum IgA, IgM and IgG．The intestinal     permeability was detected by the urinal ratio of lactulose and mannitol.   "
116672|NCT01758770|"     1. To determine the prevalences of osteoporotic fracture in elderly Chinese population.        2. To determine the prevalences of osteoporosis in elderly Chinese population using QCT BMD          measurement.        3. To investigate the difference in the prevalences of osteoporosis between cities and          urban-rural area in China.        4. To investigate the association of body composition with osteoporosis        5. To investigate the prevalence of liver steatosis in China        6. To investigate the application of QCT fat measurement   "
116673|NCT01758757|"     Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with     conventional 20, 23, and 25-gauge vitrectomy were compared.   "
116674|NCT01758744|"     An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®)     in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary     Disease (COPD)   "
116675|NCT01758731|"     This is a research study that plans to learn more about the safety and tolerability of an     investigational drug called Olaparib, in combination with radiation therapy and cetuximab.      Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a     feasible, biologically-based alternative to standard chemoradiation, with acceptable     toxicity, for treatment of locally-advanced HNSCC in patients having a ≥ 10 pack-year smoking     history.   "
116678|NCT01758692|"     People with a spinal cord injury (SCI) have limited ability to move and feel sensation below     the level of the SCI. Doctors and researchers have tests which determine the level of     function and sensation, this test was developed by the American Spinal Cord Injury     Association (ASIA) and has been modified over the years to improve use and sensitivity. Most     recently, the ASIA Injury classification Scale (AIS) was modified in 2011, but this test does     not include the evaluation of autonomic nervous system (ANS) impairment. However, people with     SCI do have impairment of the ANS and this may adversely affect how organ systems in the body     function. Specifically, ANS impairment tends to result in changes in heart rate and blood     pressure that may relate to the level of the SCI, but this is not fully understood. In this     investigation we hope to develop simple tests which will allow doctors and scientist the     ability to measure the amount of ANS impairment to the cardiovascular system, specifically     the heart. The first part of the study will be to determine the heart rate response to     several tests (administration of drugs and physical challenges) which will change heart rate.     These tests will be given to people with and without SCI and the heart rate response will be     compared between people with and without SCI. The bigger the difference in the heart rate     response to these test between people with and without SCI the greater degree of ANS     impairment in the people with SCI. Once this heart rate difference is determined, several     simple tests (deep breathing, saliva test, Valsalva) will be performed in people with and     without SCI to again compare the heart rate response. The second part of this study will be     to determine if the heart rate responses to the first set of tests (administration of drugs     and physical challenges) can predict the heart rate response to these simple tests (deep     breathing, saliva test, Valsalva). The aim of this study is to develop a simple battery of     tests which can be easily used by doctors and scientists to determine the degree of ANS     impairment to the heart in persons with SCI.   "
116680|NCT01758666|"     At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so     on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX,     the survival rate can reach about 60%, so the HD-MTX is the most important component in     patients of osteosarcoma.      Studies have shown that, MTX efficacy and adverse reactions were associated with blood     concentration level and duration, selecting the right time and dose to give CF is the     critical point.   "
116681|NCT01758653|"     The purpose of this biorepository is to collect blood from patients at the time of CO     poisoning and at follow-up visits months to years later. These samples can be used in the     future to learn more about how CO damages the heart and brain and whether blood tests could     predict which patients will have problems after CO poisoning.   "
116682|NCT01758640|"     A prospective, randomized, longitudinal, open label, parallel group clinical trial was     designed to compare the proportions of failure to reach INR target 2.5-3.5 with either: small     dose warfarin (<5 mg/day) or phenindione (<100 mg/day), in high-risk pregnant and     non-pregnant patients with bileaflet mechanical heart valve prosthesis.   "
116683|NCT01758627|"     In patients with advanced heart failure (HF), systemic congestion is the main indication for     hospitalization. Recent evidence has highlighted the role of fluid retention in the     pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney     disease, diuretic resistance, and progression of renal dysfunction often coexist in patients     with HF and persistent volume overload. This clinical presentation represents the most     extreme feature of the cardio-renal syndrome. However, available therapeutic options for this     ominous condition are scarce and limited. Indeed, there are no data from randomized control     trials using pharmacological interventions that support the beneficial effect on survival.     Interestingly, intermittent ultrafiltration has recently emerged as an alternative     therapeutic option for reducing volume overload in patients with refractory HF. Current     literature suggests that it has potential advantages over standard medical treatment     particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD)     has been preferred as an additional resource for the treatment of advanced congestive heart     failure (CHF) compared with hemodialysis because it can provide a more physiological and     continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical     functional class and hemodynamic parameters and reduced hospitalization rates in patients     with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample     size, prospective observational design with no control group, or inclusion of patients with     end-stage renal failure. Therefore, well-designed prospective randomized controlled studies     are mandatory to confirm the effects of PD in these patients.   "
116684|NCT01758614|"     The recently published Carotid Occlusion Surgery Study (COSS) failed to show a benefit of     extracranial-intracranial (EC-IC) bypass surgery over medical therapy in patients with     symptomatic hemodynamically significant carotid occlusion. Since then on, different     controversies have been raised on several aspects including the study population,     qualifications of surgeons and hemodynamic evaluation.      In COSS protocol, the primary inclusion population is the patient demonstrating occlusion of     unilateral ICA while the contralateral ICA less than 50% stenosis. Because of the enrollment     problems, in the final result report, 18% patients suffered from contralateral ICA stenosis     more than 50%. As we known, COSS utilized oxygen extraction fraction (OEF) ratio by PET as     the criterion of hemodynamic evaluation. Bilateral ICAs lesion will disturbed the ratio even     the identifying the subgroup of patients with hemodynamic insufficiency.      As an interventional trial, the COSS should ensure the certification for the experienced     surgeons. While for expanding the number of centers and enhancing recruitment, COSS made some     concessions on the surgeons training and certification. The 15% postoperative event rate is     not the best that can be achieved according to recent surgical technical development.      The cerebral hemodynamic insufficiency has been considered as the primary pathophysiological     factor for patients with ICA or MCA occlusion. For these patients, antiplatelet therapy is     not likely to prevent hemodynamic stroke.EC-IC bypass surgery probably will be the possible     effective therapy.      These underlying assumptions deserved further exploration and more strict research.So the     CMOSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery     with medical therapy in patients with symptomatic hemodynamically significant carotid     occlusion.   "
116685|NCT01758601|"     The investigators performed this study to evaluate the efficacy of regular ingestion of white     fish to reduce cardiovascular risk factors in patients with the metabolic syndrome, compared     to a diet with no fish or seafood at all.   "
116686|NCT01758588|"     The purpose of this study is to look at the effectiveness of giving patients who have been     newly diagnosed with untreated early stage primary myelofibrosis (PMF) a study drug called     PEGINTRON (also known as pegylated interferon alfa 2b). This intervention will be compared to     the widely employed watch and wait (best supportive care) approach for early stage PMF, in     which patients are followed closely and treatment initiated only if the disease progresses.   "
116725|NCT01758081|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses. This ancillary study is being conducted among participants in VITAL and will     examine whether vitamin D or omega-3 fatty acids affect risk of infection and plasma hCAP18     levels.   "
116687|NCT01758575|"     Single center, non-randomized, interventional pilot study with feasibility analysis after     enrollment of 20 patients. Adult patients with advanced solid tumors, for whom standard     palliative treatment with targeted agents as monotherapy is indicated, including     antiangiogenic tyrosine kinase inhibitors, EGFR inhibitors, mTOR inhibitors, BRAF inhibitors     and ipilimumab.After feasibility analysis in the first twenty patients, twenty more patients     will be included in each of the five drug cohorts. Biopsies will be performed to determine     possible immunohistochemical and histopathological changes in normal tissue, possible     immunomodulatory changes as expressed by Tcell phenotyping and cytokine profiling and to     compare tissue (phospho) proteomic and kinase activity profiles before and during therapy and     also at the development of toxicity.The main objective of this pilot study is to determine     the biological impact of treatment with targeted agents at the systemic and local tissue     level in relation to toxicity.   "
116688|NCT01758562|"     Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with     allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due     to their treatment.      70 patients will be randomized in the intervention (Caphosol) or in the standard     (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary     endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence     of pain measured with the NRS-scale (Numeric Rating Scale).        -  Trial with medical device   "
116689|NCT01758549|"     1. ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of          the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder          removal.        2. Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and          results in considerable suffering and cost.        3. Patients with acute pancreatitis are treated with fluids.        4. Our aim is to assess whether prophylactic treatment with aggressive intravenous          hydration prevents ERCP pancreatitis.        5. In a blinded fashion patients will be randomized to aggressive intravenous versus          moderate hydration during and aftere ERCP for standard clinical indications.      Our hypothesis is that prophylactic treatment with aggressive intravenous hydration protects     against ERCP pancreatitis.   "
116690|NCT01758536|"     The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving     neural function and life quality in patients with acute ischemic stroke in China.   "
116691|NCT01758523|"     This study will examine the safety and potential benefit of the medication dutasteride to     help men reduce or stop drinking alcohol.   "
116692|NCT01758510|"     The purpose of this study is to evaluate the safety of HLA-haplo matched Allogenic Bone     Marrow Derived stem cells(HYNR-CS-Allo inj), through intrathecal delivery for the treatment     in patients with amyotrophic lateral sclerosis(ALS).      This study is an open label, dose up and down study using the 3+3 design to assess the safety     of HLA-haplo matched Allogenic Bone Marrow Derived stem cells(HYNR-CS-Allo inj)   "
116693|NCT01758497|"     Introduction Fascia Iliaca compartment block (FICB) is commonly used to treat pain in     patients after total hip arthroplasty (THA) despite the lack of RCTs to evaluate the efficacy     of FICB for this indication. Therefore the objective of this study was to assess the     analgesic benefit of FICB for post-operative pain management in THA.      Methods After IRB approval and informed consent, patients having THA at our center in the     period 2010-2011 were recruited. Eligible patients were adults, ASA physical status I-III,     and BMI <30) with no contraindication to study procedures. In the PACU, all patients received     morphine sulfate IVPCA; patients reporting pain > 3 on the NRS-11 despite IVPCA were     randomized by the method of sealed envelopes to receive US guided injections of 30ml 0.5%     ropivacaine (FICB) or 30ml 0.9% NaCl (sham block, SB) beneath the fascia iliaca.      The primary outcome variable was opioid analgesic consumption during the first 24 h     postoperatively. Secondary outcome measures were pain intensity (NRS-11) and extent of     sensory blockade.   "
116694|NCT01758484|"     This pilot clinical trial studies supportive care for patients with hematological     malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of     life in this patient population.   "
116695|NCT01758471|"     This study is aimed to investigate the effect of acarbose on intestinal microbiome and     incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes.   "
116696|NCT01758458|"     This phase I/II trial studies the side effects and best way to give laboratory treated     autologous T cells together with aldesleukin and to see how well it works in treating     patients with merkel cell carcinoma that has spread from the primary site (place where it     started) to other places in the body. Biological therapies, such as cellular adoptive     immunotherapy, may stimulate the immune system in different ways and stop tumor cells from     growing. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving cellular     adoptive immunotherapy with aldesleukin may be a better treatment for metastatic merkel cell     carcinoma.   "
116697|NCT01758445|"     The purpose of this study is to look at the rates of acute and long term adverse events of     postoperative proton radiotherapy for complex loco-regional irradiation in women with     loco-regionally advanced breast cancer. This study specifically includes longitudinal follow     up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15     years following proton therapy(PT).   "
116698|NCT01758432|"     The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of     several blood thinner drugs on laboratory tests. The study also is evaluating the blood     levels of PRT064445 given at different doses.   "
116726|NCT01758068|"     The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits     even more vulnerability to the environment due to poor self regulatory heat mechanisms,     paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight     as water loss from their skin during the first week of life. Many strategies have been     utilized by neonatologists to decrease this water loss. Edible coconut oil application on the     skin acts as a non permeable barrier and can help in achieving this. Hence the investigators     decided to undertake this study to objectively assess the reduction in water loss from skin     after oil application.   "
116727|NCT01758055|"     The purpose of this study is evaluating the safety of endobronchial transplantation of     autologous mesenchymal stem cells derived bone marrow in patients with emphysema.   "
116699|NCT01758419|"     Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose     delivered to each region of the heart in left-sided breast cancer therapy, which allows     greater sparing of the heart from doses associated with increased complications. However,     heart disease shows a wide spectrum of pathologies, and multiple risk factors related. The     damage of the myocytes may lead to not only myocardial perfusion defects, but also in     functional deterioration, or even in biomarkers. In this study, we will monitor     cardiovascular (CV) risk factors, metabolism, biomarkers, myocardial perfusion defect     patterns, and cardiac functional parameters, in order to delineate of RT-related effects and     clinical impacts.      Objective: The pilot study aims to investigate the correlation of post-tomotherapy     cardiovascular effects with myocardial perfusion and cardiac functional studies.      Methods: The study plans to enroll female breast cancer patients who will undergo local RT     after their surgery. Patients will receive global risk scoring assessment (Framingham Risk     Score, FRS), blood sampling for basic biochemistry, inflammatory biomarker, and myocardial     perfusion image (MPI) at the time points of before and after RT. The results of MPI will be     analyzed in qualitative visual interpretation of perfusion patterns, and functional     quantitative data for cardiac functional parameters as well. The patients will be regular     followed-up in CV OPD. The association between baseline and follow-up MPI, biomarker and     clinical presentation will be further investigated.   "
116700|NCT01758406|"     This study is a prospective, randomized, double blind , controlled trial to assess the     efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients     with ischemic heart failure.   "
116701|NCT01758393|"     This is a randomized, open-label, single-center clinical trial to compare the efficacy and     safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related     Disease. Patients will be followed for three months to measure the primary outcome and     secondary outcomes.   "
116702|NCT01758380|"     To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in     Muslim patients with type 2 diabetes fasting during Ramadan.   "
116703|NCT01758367|"     Decitabine can up-regulate a series of immune associated proteins, including cancer testis     antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion     molecules, which suggests a potential benefit for a following adoptive T cell therapy. In     addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T     regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by     treatment of decitabine.   "
116704|NCT01758354|"     The purpose of this study is to test the feasibility of a newborn screen assay for Pompe     disease   "
116705|NCT01758341|"     Biliary obstruction is importantly influencing quality of life and survival of patients     suffering from primary or secondary bile duct malignancies. The aim of this retrospective     data analysis is to evaluate endoscopic radiofrequency ablation (RFA) with the HabibTM     EndoHBP catheter for the treatment of malignant biliary obstruction. RFA procedures performed     in Austria so far will be analyzed with regard to feasibility and safety of the technique.     Therefore, the following parameters will be assessed: (among others) technical failures     during the RFA procedure, complications during the RFA procedure, hospital stay, adverse     events during hospital stay and until first clinical control after discharge (an expected     average of 4 weeks after RFA procedure), 30-day and 90-day mortality. The results of this     study should help to better understand important aspects of biliary RFA which may positively     influence future applications of this method.   "
116706|NCT01758328|"     The purpose of this study is to test the safety of specialized white cells from the donor at     different doses. They are called WT1 sensitized T cells. They have been grown in the lab and     are immunized against a protein. The protein is called the Wilms' tumor protein, or WT1. The     multiple myeloma cells make and express this protein. The investigators want to learn     whether the WT1 sensitized T cells will attach to the protein and kill the myeloma cells. The     investigators want to find out what effects, good and/or bad, it has on the patient and     multiple myeloma.   "
116707|NCT01758315|"     The purpose of the Proactive Reduction of Outpatient Malpractice: Increasing Safety,     Efficiency, and Satisfaction (PROMISES) project is to assemble a high-level Massachusetts     consortium to test the impact of powerful quality improvement techniques to accomplish     innovations and improvements in high risk ambulatory malpractice areas. We will target     problem-prone processes in 3 areas of identified risk: 1) medication management, 2) test     ordering and results management 3) follow-up and referral management.   "
116708|NCT01758302|"     This one time pilot laboratory study focuses on examining the relationship between different     types of physical tasks and taste perception of high and low-calorie foods among hungry     individuals.   "
116709|NCT01758289|"     This study was designed to evaluate the effectiveness, safety, and impact on quality of life     when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on     hemodialysis who are at risk of developing secondary hyperparathyroidism associated with     stage V chronic kidney disease.   "
116710|NCT01758276|"     This will be a retrospective study. Details on all women who delivered in McGill University     between 2001-2007 will be retrieved anonymously from the MOND database (McGill University     Obstetrics and Neonatal database). Women will be divided to 2 groups according to their     smoking status in pregnancy. Obstetric complications will be recorded in both groups.   "
116711|NCT01758263|"     This is a retrospective data analysis of patients with high blood pressure (hypertension) who     took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a minimum     of 6 month to treat hypertension. These patients will be identified from a large medical     claims database. This study tests the hypothesis (alternative, higher or lower) that average     patient monthly health care administrative cost changes after switching from metoprolol to     nebivolol.   "
116751|NCT01757743|"     This project will evaluate fluid balance and oedema formation in children with the same     congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with     the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization.     The investigators will measure interstitial colloid osmotic pressure, distribution of     proteins and cytokines. The study hypothesis is that Oedema developed during heart surgery     is caused by reduced colloid osmotic pressure gradient through the capillary membrane.   "
116712|NCT01758250|"     In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal     Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical     Coherence Tomography (OCT) will be used to assess differences in microvascular function and     density of oral mucosa and skin in subjects with 1) autoimmune diseases with cutaneous     involvement: systemic sclerosis (SSc), morphea, dermatomyositis, cutaneous lupus and     vasculitis, 2) sickle cell disease (SCD) and 3) chronic graft-versus-host disease (GVHD)     compared to healthy subjects. The microvascular changes will be compared to overall treatment     response in patients with scleroderma and chronic GVHD as assessments will be made before and     after the patients start treatment for their diseases and determine if these imaging     techniques provide valuable and reproducible data when assessing a patient's response to     treatment for those diseases. In addition, the application of Acoustic Radiation Force     Impulse (ARFI) in determining cutaneous thickness in patients with SSc, GVHD and morphea will     be evaluated.      The investigators hypothesize that the vascular and dermal structures are altered in patients     with autoimmune disease, SCD and chronic GVHD. In addition, they hypothesize that imaging     modalities such as LDF, LDI, OCT, NVC, OPSI and ARFI can quantify such structural alterations     and can be used to 1) detect early disease activity, 2) quantify and assess response to     therapy and 3) quantify and correlate with overall disease activity.   "
116713|NCT01758237|"     To establish the correlation of the location of the Nd:YAG laser peripheral iridotomy to the     post operative visual symptoms experienced by some patients. The investigators hypothesize     that fully uncovered laser peripheral iridotomy will produce less significant dysphotopsia,     due to avoidance of the prismatic effect produced by the tear film than those covered.   "
116714|NCT01758224|"     Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect     motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle     weakness are common in the terminal stages of MS and contribute to mortality in these     patients. Respiratory muscle weakness may also impair the performance of coughing and     aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic     stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through     nerve activation. Over the last few years, the study investigators have demonstrated efficacy     of FMS technology for stimulating respiratory muscles in animal models, able-bodied subjects     [3] and spinal cord injured (SCI) patients [4]. In this study, the researchers will     investigate the efficacy of using FMS technique for respiratory muscle conditioning in     patients with MS. Furthermore, the investigators will also compare expiration related     outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology.      Hypotheses        1. FMS conditioning of the expiratory muscles can generate significant expiratory flows and          pressures in patients with MS.        2. FMS conditioning of expiratory muscles is more effective compared to resistive          expiratory muscle training (REMT) in patients with MS.   "
116715|NCT01758211|"     Little is known about the effect of fMRI navigation in the intracranial arteriovenous     malformation surgery. The investigators aim to perform a multicenter prospective randomized     single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain     arteriovenous malformation surgery.   "
116716|NCT01758198|"     The purpose of this study is to compare the clinical efficacy including joint damage     progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.   "
116717|NCT01758185|"     The objective of this study was to evaluate the safety and immunogenicity of one inactivated     split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.   "
116718|NCT01758172|"     From postoperative patients having undergone pancreaticoduodenectomy;        1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6%          Voluven        2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory          parameters of the patient        3. To compare the safety of the 2 intravenous colloids in the patient population   "
116719|NCT01758159|"     Complementary feeding diet in developing countries cannot meet iron requirements of infants     and young children. Iron supplementation is mostly used to treat iron deficiency whereas iron     fortification is cost-effective strategy to control iron deficiency in developing countries.     However, a recent study showed that iron fortification imposed negative impact on gut     microbiota by increasing colonization of gut pathogen over beneficial bacteria. Gut     microbiota plays essential roles in nutrient absorption, vitamin synthesis; intestinal     mucosal barrier function and pathogen displacement. Iron is essential for growth and     virulence of most gut pathogens and so iron supplementation might have similar negative     impact on gut microbiota composition. Therefore, nutrition interventions would not be     justified by assessing micronutrient status alone ignoring any possible deterioration of gut     microbiota. The investigators hypothesized that optimizing the nutrient intake from locally     available foods according to complementary feeding recommendation (CFR) can improve the iron     status of these children while maintaining healthy gut microbiota composition.      A randomized, placebo-controlled, community-based, intervention trial will be conducted in     Ayeyarwady division of Myanmar where childhood undernutrition is prevalent. The aim of this     study is to compare the effect of optimized CFR to iron supplementation on iron status and     gut microbiota composition of 1-2years old Myanmar children. Cluster randomization will be     done at the village level to randomly allocate the villages into CFR or non-CFR villages.     Individual randomization will be done to randomly assign each child into iron or placebo     syrup so that individual children will receive one of 4 treatment groups (CFR, Fe, CFR + Fe,     and Control) for a period of 24 weeks. Based on expected between-groups difference of     hemoglobin 5g/L, at 80% power, 5% level of significance, 15% drop-out rate; after taking into     account the cluster effect; required sample will be 109 per group (total = 436). A sub-sample     of 15 children from each group will be randomly selected for gut microbiota assessment (total     = 60). Blood samples for iron status and stool samples for gut microbiota assessment will be     collected at baseline and endline. Anthropometric measurements, usual intake of iron and     infectious disease morbidity will also be assessed.   "
116720|NCT01758146|"     To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase     inhibitors in postmenopausal patients with early breast cancer in terms of:      i) Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall     survival   "
116721|NCT01758133|"     The aim of this study is to determine whether medical clown activity enables relaxation of     mothers of premature infants, and as a result increases their breast milk production.   "
116722|NCT01758120|"     Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone     alone in patients with advanced-stage IgA nephropathy.   "
116723|NCT01758107|"     Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and     Calcineurin inhibitor withdrawal.   "
116724|NCT01758094|"     The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with     insulin resistance and influence of testosterone treatment on this cytokine in patients with     idiopathic hypogonadotropic hypogonadism.   "
118991|NCT01728428|"     To determine the clinical manifestation, diagnosis and treatment options of primary     hemifacial spasm in Chinese outpatient subjects   "
116728|NCT01758042|"     The main purpose of this study is to examine the outcome of a combined bone marrow and kidney     transplant from a partially matched related (haploidentical or haplo) donor. This is a     pilot study, you are being asked to participate because you have a blood disorder and kidney     disease. The aim of the combined transplant is to treat both your underlying blood disorder     and kidney disease. We expect to have about 10 people participate in this study.      Additionally, because the same person who is donating the kidney will also be donating the     bone marrow, there may be a smaller chance of kidney rejection and less need for long-term     use of anti-rejection drugs.      Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to     prepare a subject's body for bone marrow transplant. This is associated with a high risk for     serious complications, even in subjects without kidney disease. This therapy can be toxic to     the liver, lungs, mucous membranes, and intestines. Additionally, it is believed that     standard therapy may be associated with a higher risk of a complication called graft versus     host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently,     less intense chemotherapy and radiation regimens have been employed (these are called reduced     intensity regimens) which cause less injury and GVHD to patients, and thus, have allowed     older and less healthy patients to undergo bone marrow transplant. In this study, a reduced     intensity regimen of chemotherapy and radiation will be used with the intent of producing     fewer toxicities than standard therapy.      Typical therapy following a standard kidney transplant includes multiple lifelong medications     that aim to prevent the recipient's body from attacking or rejecting the donated kidney.     These are called immunosuppressant drugs and they work by quieting the recipient's immune     system to allow the donated kidney to function properly. One goal in our study is to decrease     the duration you will need to be on immunosuppressant drugs following your kidney transplant     as the bone marrow transplant will provide you with the donor's immune system which should     not attack the donor kidney.   "
116729|NCT01758029|"     This study will be conducted as a prospective, single-center (multiple clinics), single-arm     open phase IV study.      the study will follow hypogonadal patients, and aimed to confirm the hypothesis that     testosterone undecanoate improves the patient satisfaction and quality of life, with parallel     improvement in their spouses's quality of life and satisfaction. Each patient/spouse will     serve as his own control.   "
116730|NCT01758016|"     Pregnancies of patients with Diabetes are associated with increase adverse pregnancy outcome     . The risk for vascular complications including: Intra uterine growth restriction (20%),     hypertension (31%), preeclampsia (15%), eclampsia and placental abruption are significantly     greater than those in background populations. The risk of developing vascular complications     in diabetes pregnancies although is correlated with the severity and length of the disease is     not fully understood. Enhanced oxidation has been suggested to be the underlying abnormality     responsible for some of the complications of diabetes.      Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The best     understood function of Hp is to bind free hemoglobin (Hb) released from red blood cells.     Extracorpuscular Hb is a potent Fenton reagent.capable of of inflicting oxidative tissue     damage. Hp binds to Hb and serves to inhibit the oxidative potential of Hb by preventing the     release of heme iron.      The haptoglobin (Hp) gene at chromosomal locus 16q22 is polymorphic, with two common alleles     denoted 1 and 2. the prevalence of Hp 1-1, Hp 1-2 and Hp 2-2 genotypes is approximately 16%,     48% and 36%, respectively. In the western world. A total of five independent longitudinal     studies have demonstrated that DM individuals with Hp 2-2 genotype have a two to five-fold     increased risk of CVD as compared to DM individuals without the Hp 2-2 genotype We sought to     determine whether HP genotype plays important role in development of vascular complications     in pregastational pregnancies. and whether Hp genotype 2-2 is a risk factor for developing     gestational diabetes (GDM)   "
116731|NCT01758003|"     The primary aim of this research is to examine physical activity in a healthy population aged     over 40 years old.      Subsidiary aims of this research are:        1. To establish normative values for physical activity levels, exercise capacity, quality          of life and readiness to change physical activity behaviour (stages of change,          self-efficacy, decisional balance and processes of change) in a healthy population          age-matched to a population with bronchiectasis.        2. To explore physical activity levels, exercise capacity and quality of life in a healthy          population age-matched to a population with bronchiectasis.        3. To explore readiness to change physical activity behaviour (stages of change,          self-efficacy, processes of change and decisional balance) in a healthy population          compared to a population with bronchiectasis.   "
116732|NCT01757990|"     The aim of the present investigation was to evaluate the effect of stevioside and     rebaudioside on several variables related to caries development. Two approaches were     performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in     vivo randomized study on the effect of a single rinse containing stevioside and rebaudioside     on plaque-pH.   "
116733|NCT01757977|"     The investigators have performed a number of studies on novel airway devices. In this     randomized controlled trial he investigators would like to compare the performance of a new     double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard     double lumen tube.   "
116734|NCT01757964|"     In this study, the investigators want to see if Bacteriotherapy (also referred to as stool     transplantation) improves the symptoms and decreases inflammation in children with     Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis.     Additionally, researchers want to learn whether this experimental therapy delays the need for     starting additional medications to treat pediatric IBD.   "
116735|NCT01757951|"     A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are     treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of     the posterior malleolus. There is significant evidence that fractures of the lateral     malleolus can be treated conservatively if the medial side is stable. However, there isn't a     single study comparing standard bi- or trimalleolar fixation with only medial side     osteosynthesis and postoperative immobilization with a cast.   "
116736|NCT01757938|"     Adult male circumcision (AMC) can reduce the incidence of HIV transmission by 40-60% in     sub-Saharan Africa (SSA). The World Health Organisation and Joint United Nations Programme on     HIV/AIDS advocate AMC for the reduction of HIV transmission in heterosexual men, and     feasibility studies have demonstrated that AMC programmes can be effectively delivered to     hyperendemic communities, such as those in SSA. Despite these recommendations, the potential     effects of AMC have been attenuated by low uptake, with only 5% of all men who could benefit     undergoing surgery to date. Traditional, time-consuming methods of AMC that require formal     surgical training limit uptake in low-income countries. Training and implementation by     non-physician health providers is dampened by a need to perform approximately 100 procedures     to achieve satisfactory operative time and adverse effect rates. The investigators performed     a randomised controlled effectiveness study to compare the shang ring (SR) with standard     forceps-guided (FG)-AMC in a publicly funded regional referral hospital with a locally     trained surgeon in Mbarara, western Uganda.   "
123963|NCT01663207|"     A multi-year clinical study to improve tools for measuring the function of insulin-producing     beta cells in people with type 2 diabetes mellitus.   "
116737|NCT01757925|"     Recently, researchers have been interested in the use of game play, mechanics and psychology     for health-related engagement and behavior change. While initial studies have shown some     increases in health knowledge and/or behavior through gaming, there remains concern that the     vehicle for change is associated with a perceived sedentary behavior (6).      More recently, commercially available gaming devices are able to directly promote physical     activity through a new set of kinetic controllers added to the gaming experience. UHG plans     to evaluate the most recent of these kinetic controller technologies in the context of a     second iteration of JOIN (described above) to be implemented among a pilot group of     overweight and/or obese children whose BMI percentile is above the 85th.      This study will evaluate the effect of a commercial controller-free Exercise Gaming and     Entertainment Experience (EGEE) on physical activity levels in the context of a weight     management program in approximately 70 children ages 6 to12. The study will compare the     differences in physical activity levels over 16 weeks in two groups of children.   "
116754|NCT01757704|"     The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It     consists of two main elements namely, opening of both pleura after the patient is on CPB     (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to     ensure bilateral pulmonary collapse and a staged filling of the heart at termination of the     CPB. The aim of this study is to analyze in a randomized manner two groups of patients to     establish if one or both components are of primary importance for the effectiveness of the     de-airing technique.   "
116738|NCT01757912|"     The endotracheal tube secures free airway in patients undergoing surgical procedures or     mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs     to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A     cuff pressure in excess of the target range is associated with a risk of tracheal injury,     whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of     subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is unknown     whether the cuff pressure changes following changes in body position of the patient. The     objective of this study is to investigate to which extent - if any - cuff pressures change     after body position changes of the patient.   "
116739|NCT01757899|"     The purpose of this study is to investigate the effects of prolonged low-dose     methylprednisolone infusion on pulmonary function (LIS and ventilation-free days), extra     pulmonary organ function (PMODS score), inflammatory markers - RCP (Reactive C Protein), IL6     (Interleukine 6), TNFα (Tumor Necrosis Factor), IL8 (Interleukine 8), IL10 (Interleukine 10)     and length of Pediatric Intensive Care Unit (PICU) stay in early ALI/ARDS in children.   "
116740|NCT01757886|"     The prognostic value of inflammatory markers in acute coronary syndrome has been extensively     demonstrated, however it is still unknown whether there is an association between circulating     and local (thrombus) inflammatory molecules, and the subset of molecules that provide better     prognostic information in patients with ST-elevation acute coronary syndrome.   "
116741|NCT01757873|"     This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety     and efficacy for a period of 6 weeks.   "
116742|NCT01757860|"     Study Phase: Phase 1      Primary Objective:      • To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in     healthy subjects      Secondary Objectives:        -  To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single oral          doses of CARD-024        -  To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin          activity (PRA) and blood pressure (BP), biological markers of activity, following          ascending single oral doses of CARD-024   "
116743|NCT01757847|"     This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group     intervention to an active control group in a sample of 154 overweight or obese binge eating     Veterans who have completed the VA's national behavioral weight management program (MOVE!).     This study anticipates that the ACT intervention will reduce binge eating and distress while     improving functioning and maintenance of weight loss.   "
116744|NCT01757834|"     Shear wave ultrasound elastography is a new technique of finding the softness or hardness in     tissue by applying a push generated by the machine. This technique will help in diagnosing     malignancy in the thyroid gland without biopsy and avoiding biopsy in noncancerous nodules.   "
116745|NCT01757821|"     The goal of stroke rehabilitation is to restore function to the weak side of the body.     However, this is often a difficult task to accomplish due to not only to damage from the     stroke, but from increased excitability in the non-stroke side of the brain that inhibits the     stroke side from functioning optimally. Repetitive transcranial magnetic stimulation (rTMS)     is a non-invasive form of brain stimulation that can enhance excitability in the stroke side     when applied at a low-frequency on the non-stroke side. By inhibiting the inhibition (i.e.     disinhibition), rTMS promotes adaptive brain reorganization following stroke. Previous     research in healthy individuals demonstrates enhanced effects of low-frequency rTMS when it     is preceded by high-frequency (excitatory) rTMS stimulation known as priming. Our lab     previously demonstrated the safety of 6-Hz priming with low-frequency rTMS in both adults and     children with chronic stroke. However, it is currently unknown whether or not the addition of     priming stimulation to low-frequency rTMS enhances excitability in the stroke hemisphere. Our     study will examine three rTMS interventions in twelve adults (at least 18 years): 1.) 10     minutes of real priming followed by 10 minutes of low-frequency rTMS, 2.) 10 minutes of fake     priming followed by 10 minutes of low-frequency rTMS, 3.) 20 minutes of low-frequency rTMS     only. Participants will receive all three interventions in randomized order. Each week,     participants will complete two pretest and 3 posttest sessions consisting of behavioral     measures of weak upper extremity function and cortical excitability in addition to receiving     one rTMS intervention. Following each week of testing and treatment, subjects will take a one     week rest break before crossing-over to receive another intervention. We hypothesize the     following: 1.) Primed rTMS will result in significantly reduced inhibition and significantly     increased excitation on the stroke side vs. fake primed rTMS or low-frequency rTMS given     alone and 2.) Primed rTMS will result in greater improvements of paretic hand function. This     study is innovative in that it intends to compare primed and unprimed rTMS in the stroke     brain that could acknowledge a more effective delivery method of rTMS to potentially yield     greater rehabilitative outcomes.   "
116746|NCT01757808|"     The purpose of this study is to assess the safety of ranolazine in people with pulmonary     arterial hypertension (PAH) and who are receiving 1 or more background PAH therapies:     ambrisentan, sildenafil,tadalafil, epoprostenol, treprostinil (IV, SC, inhaled), or iloprost.     The primary objective is:        -  To estimate the effect of ranolazine administration on acute hemodynamics.        -  To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after          12 weeks of therapy        -  To assess changes in right ventricular function after 12 weeks of therapy.   "
116747|NCT01757795|"     Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of     escalating single doses and multiple doses of SP-8203   "
116748|NCT01757782|"     The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary     Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns     and to study risk factors of MAS developing into PPHN.   "
116749|NCT01757769|"     The purpose of this study is to confirm in a larger population in Europe the effectiveness     and safety observed with silodosin in previous clinical trials.   "
116750|NCT01757756|"     This study is designed to assess the safety, tolerability and pharmacokinetics of multiple     oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight     and obese subjects.   "
116752|NCT01757730|"     Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of     soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is laid     in an MR scanner and a paddle (plastic drum) is put on the area of interest to send sound     vibration via a speaker placed outside the scan room which is connecting plastic drum via a     plastic tube. These vibrations are scanned using MRI to estimate the stiffness of soft     tissues such as liver, heart, kidneys, breast etc.   "
116753|NCT01757717|"     The purpose of this study is to see if using a form of imaging during surgery helps the     doctors to guide the placement of radiation catheters more accurately.      This method, called image-guided surgical navigation may allow the doctors to deliver     radiation to the tumor that the patient needs and decrease the amount of radiation delivered     to the nearby areas.   "
116755|NCT01757691|"     To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with     suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment   "
116756|NCT01757678|"     To determine the diagnostic performance of FFRCT by coronary computed tomographic angiography     (cCTA), as compared to cCTA alone, for non-invasive determination of the presence of a     hemodynamically significant coronary lesion, using direct measurement of fractional flow     reserve (FFR) during cardiac catheterization as a reference standard.   "
116757|NCT01757665|"     The objective of this trial is to confirm that the modifications to tissue processing, valve     sterilization and packaging do not raise any new questions of safety and effectiveness in     subjects who require replacement of their native or prosthetic aortic or mitral valve.   "
116758|NCT01757639|"     This phase I trial studies the side effects and best dose of ipilimumab and how well it works     in treating patients with high-risk myelodysplastic syndrome or acute myeloid leukemia that     has come back or no longer responds to treatment. Monoclonal antibodies, such as ipilimumab,     may interfere with the ability of cancer cells to grow and spread.   "
116759|NCT01757626|"     The purpose of this study is to find out if an antibody called Humanized 3F8 (Hu3F8) combined     with granulocyte- macrophage colony stimulating factor (GM-CSF) is safe for treating     neuroblastoma.   "
116760|NCT01757613|"     In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated     with respect to safety and efficacy in order to identify the optimal concentration in the     topical formulation.      The main objective of the trial is to determine the optimal concentration of the active agent     in the topical formulation as quantified by the change of the number of skin alterations in     pre-defined areas in a time period from inclusion in the trial until the end of treatment (3     months) or prior complete healing.   "
116761|NCT01757600|"     To evaluate the correlations between anatomical and functional changes studied with     microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of     idiopathic macular hole (MH).   "
116762|NCT01757587|"     The main objective is to show that the addition of Galvus versus placebo in patients with     type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin     properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.      The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c     less than 7%) after 3 months of treatment with Galvus or placebo   "
116763|NCT01757574|"     The objectives of this study are to determine the safety, tolerability and preliminary     efficacy of alemtuzumab for infusion for the treatment of CIDP. Eligible subjects will be     treated with alemtuzumab at the beginning of the study and then followed for three years.     During the three year period, subjects will under go monthly safety evaluations consisting of     blood and urine testing, symptom surveys and examination. Detailed neurological testing     including nerve conduction testing, Rasch-built Overall Disability Scale (CIDP/RODS) and     Overall Neuropathy Limitations Scale (ONLS) assessments will be performed every six months     for three years.      The study will also investigate and compare the responsiveness of the outcome measures being     used.   "
116764|NCT01757561|"     the purpose of this study is to investigate whether propofol and sevoflurane have difference     effect on cerebral oxygenation .   "
116765|NCT01757548|"     The purpose of this study is to determine whether high ligation of spermatic vein by open     operation and microsurgery for patients with are effective in the treatment of varicocele and     to determine which surgical option is better.   "
116767|NCT01757522|"     Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right     ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary     vascular resistances and pressure load. This can be prevented by modifying ventilator     settings, using vasopressors or inotropes or even by prone positionning.But to do so, right     ventricular dysfonction has to be detected. Echocardiography has emerged as a first line tool     to diagnose right heart failure. Recently, strain analysis showed promising results to detect     early right ventricle abnormalities in other settings such as pulmonary hypertension or     scleroderma. We therefore decided to determine whether 2D strain could help detect early     right ventricular dysfunction in ARDS.   "
116840|NCT01756560|"     Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic     nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it     in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief     after surgery at home.   "
116768|NCT01757509|"     The aim of this study is to investigate if set dancing is beneficial and feasible for those     with Parkinson's disease in Ireland. The hypothesis of this feasibility study are that:        -  Participants will be able to partake fully in the intervention without reporting adverse          events.        -  There will be evidence of gains in functional exercise tolerance, balance, motor          performance and quality of life in those with Parkinson's disease who participate in          eight weeks of set dancing classes compared to a control group.   "
116769|NCT01757496|"     RSV bronchiolitis in children is still associated with significant morbidity and mortality.     RSV infection results in increased mucus production, edema and inflammation at the lower     airways and impaired mucociliary clearance. Infants and children under the age of 1 year are     particularly vulnerable to complications such as atelectasis and secondary bacterial     infection. These children often need non-invasive or invasive ventilation. Atelectasis is     common in these children because of smaller airways and decreased cough strength. There is     still much uncertainty about the treatment of RSV. Treatment consists primarily of supportive     therapy such as tube feeding and additional respiratory support if necessary. There is also     limited evidence about the use of nebulizers with beta-agonists and/or hypertonic saline.      The cough assist is a mechanical in- and exsufflator used primarily in patients with     neuromuscular diseases to augment cough capacity. In these patients, it was demonstrated that     the use of assisted cough resulted in a significant decrease in the number of respiratory     infections. Moreover, there is evidence that when used in the case of an acute respiratory     deterioration such a massive atelectasis, the atelectasis can be corrected and intubation can     be avoided. The aim of this study is to investigate if the use of the CoughAssist device in     children with RSV bronchiolitis is associated with a better respiratory outcome.   "
116770|NCT01757483|"     This study is designed to evaluate the effectiveness of the current ticagrelor risk     minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey     of selected important identified safety concerns (i.e., bleeding, dyspnea and drug     interactions) and ASA dosage.   "
116772|NCT01757457|"     Intracoronary abciximab administration during primary percutaneous coronary intervention     (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was     to assess whether abciximab administration route could influence its anti-inflammatory     effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an     intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of     inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.   "
116773|NCT01757444|"     In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could     offer potential advantages over fixed level pressure support, in particular, in patients with     obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an     innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency     while delivering the correct level of ventilation each user requires, whatever their body     position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the     initial titration of therapy, while providing long term comfort and assuring therapy     compliance. However, studies on the physiologic and clinical effects have not yet been     performed. The aim of our singled-blind randomised multicentre controlled trial is to     prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the     AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange,     symptoms, body composition, level of physical activity and health-related quality of life in     OHS patients.   "
116774|NCT01757431|"     Protocol is intended to characterize the overall safety and tolerability of eculizumab in     this population.   "
116775|NCT01757418|"     The purpose of this study is to determine whether intravenous immune globulin is safe and     effective in the acute treatment of pain crises in sickle cell disease.      Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development     (OOPD)   "
116776|NCT01757405|"     The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a     six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.   "
116777|NCT01757392|"     The primary objective of this study is to determine the safety of Candin® (Candida albicans     Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common     warts (Verruca vulgaris).   "
116778|NCT01757379|"     The purpose of the study is to evaluate the bioavailability of acetate, propionate and     butyrate in healthy humans using a stable isotope technology.      In addition the level of acetate, propionate and butyrate production from inulin will be     determined using the principle of isotope dilution.   "
116779|NCT01757366|"     Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in     Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3     in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.   "
116780|NCT01757353|"     The goal of this research study is to compare three harm reduction approaches for at-risk     college student drinkers. One approach provides generic risk-related information after an     initial interview/questionnaire assessment session. A second approach uses an established     motivational interviewing framework (Brief Alcohol Screening and Intervention for College     Students; BASICS) that provides personalized feedback in a follow-up session. A third     approach also uses BASICS, but tests the utility of a personality-informed module for this     approach that is informed by the social investment hypothesis.   "
116781|NCT01757340|"     The purpose of this study is to determine whether consuming additional leucine during calorie     restriction induced weight loss has beneficial or harmful effects on multi-organ (liver,     muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut     microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal     women.   "
116782|NCT01757327|"     This randomized phase II trial studies the effects of erismodegib (LDE225) on disseminated     tumor cells (DTCs) in patients with stage III-III estrogen receptor (ER)-negative and human     epidermal growth factor receptor 2 (HER2)-negative breast cancer. The presence of DTCs after     completing treatment for breast cancer may be linked to recurrence of the disease. LDE225 may     eliminate DTCs in bone marrow and reduce the risk of recurrence.   "
116783|NCT01757314|"     When surgery is performed under general anesthesia, a catheter is placed in a vein to     administer drugs and saline. During major operations, an additional catheter is placed in an     artery in order to measure the blood pressure closely and withdraw blood samples at frequent     intervals for various laboratory tests. This arterial catheter is usually placed by feeling     the patient's artery at the wrist and inserting the guide-needle in a blind fashion. This     procedure, at times, leads to delays and failures due to an inability to feel the arterial     pulsation well either due to the patients' anatomy or the anesthetic effect. This study will     determine whether training Anesthesiology Residents in the use of ultrasound technology and     its application in identifying an artery can prevent the problems associated with the     conventional palpation technique. Our finding will lead to better and safer anesthetic     management of patients presenting for a major surgical procedure. Furthermore, the finding     will help us in introducing the education and training of ultrasound-guided arterial catheter     placement in our Residency Program.      The investigators propose to follow anesthesia residents over a course of 3 years assessing     their skill level for both palpation and ultrasound technique.   "
116784|NCT01757301|"     Pain is the most common presenting symptom in medical outpatients, and depression and anxiety     are the two most common mental disorders. All three conditions are often inadequately treated     and result in substantial disability, reduced health-related quality of life, and increased     health care costs and utilization. Additionally, pain, anxiety, and depression (PAD) are     frequently comorbid with one another and have reciprocal negative effects on treatment     response and additive effects on adverse health outcomes. The PAD triad is especially     burdensome in Veterans, with their high prevalence of chronic pain, depression, PTSD, and     other anxiety disorders. The Comprehensive vs. Assisted Management of Mood and Physical     Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the     relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary     care in the management of Veterans suffering from with pain plus comorbid anxiety and/or     depression.   "
118040|NCT01740895|"     To assess the clinical value of iFR to characterize, without concomitant administration of     hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as     determined with fractional flow reserve (FFR)   "
116785|NCT01757288|"     The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and     carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no     published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators     will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at     50mg/m2, and then will begin enrolling patients into the phase II component using either     Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or     paclitaxel with with carboplatin concurrent with daily radiation.   "
116786|NCT01757275|"     To describe the rate of clinically significant rebleeding during 72 hours continuous i.v.     infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic     haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in   "
116787|NCT01757262|"     Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12     Receptor Inhibition Effects of Ticagrelor and Clopidogrel   "
116788|NCT01757249|"     Endometriosis is a hormone dependent disease of women, in which endometrial tissue (the cells     which line the uterus or womb) are found outside the uterus (womb). Some women with     endometriosis may be infertile. However, treatments for infertility such as in vitro     fertilization (IVF) or IVF with intracytoplasmic sperm injection (IVF-ICSI) appear to be less     successful, i.e. the pregnancy rates are lower, for women with endometriosis than for women     who may be infertile for other reasons.      Since endometriosis is hormone dependent, it has been suggested that suppressing the activity     of hormones produced by the ovaries (which affect endometrial growth) may inactivate     endometriosis and so increase the chances of pregnancy. Recently it has been proposed that     taking the oral contraceptive pill (OCP) for 6 to 8 weeks before IVF or IVF-ICSI treatment     could be used for this purpose.      For our study, which is a randomised controlled trial, women with endometriosis meeting the     study criteria planning to undergo IVF or IVF-ICSI at the Oxford Fertility Unit will be     recruited. Study participants will be randomised into 2 arms: experimental group and control     group. The experimental group will be instructed to complete an 8 week course of OCP before     beginning standard IVF treatment. The control group do not take any study medication before     beginning standard IVF treatment. The IVF or IVF-ICSI treatment for both groups is not     altered by participation in the study.      The aim of the study will be to determine if pretreatment with OCP improves IVF or IVF-ICSI     success rates, such as live birth and pregnancy rates, in patients who suffer from     endometriosis. The study is funded by the Oxford Fertility Unit.   "
116789|NCT01757236|"     The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination     therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive     prosthetic hip joint infection with a one-stage surgical treatment.   "
116790|NCT01757223|"     The proposed Phase I/II clinical trial will be used to determine the safety and toxicity of     direct administration of the vector AdVEGF-All6A+ to the ischemic myocardium and to generate     preliminary evidence regarding whether direct administration of AdVEGF-All6A+ to the ischemic     myocardium will induce growth of collateral blood vessels and improve cardiac function. This     is a three-part, multinational/multi-center, placebo controlled study.   "
116791|NCT01757210|"     Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting     that cancer patients experience after treatment. Aprepitant has been well-studied in adults,     but not in children. Data from adult studies has shown aprepitant to be safe. It has also     been shown to be effective in lessening the amount of nausea and vomiting that adult patients     experience. Because aprepitant has been shown to be safe and effective, the investigators     have been using it in pediatric patients at this hospital as standard of care. The     investigators will be surveying patients already receiving aprepitant for prevention of     chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they     experience. The investigators will also be surveying these patients to determine what their     appetite is like and if they experience any disruptions in activities of daily living. The     investigators are also going to be assessing any side effects these patients experience from     receiving aprepitant.   "
116792|NCT01757197|"     The purpose of this study is to determine if Tocilizumab is a safe and effective treatment     for steroid-refractory acute graft versus host disease.   "
116793|NCT01757184|"     This Phase 3 study will evaluate the efficacy and safety of 1 mg/kg IV infusions of SBC-102     (sebelipase alfa) administered every other week in patients with late onset lysosomal acid     lipase (LAL) deficiency (cholesteryl ester storage disease).      Late onset LAL Deficiency is an underappreciated cause of cirrhosis, liver failure and     dyslipidemia. There is currently no standard treatment for LAL Deficiency other than     supportive care. Enzyme replacement therapy (ERT) may be a potential new treatment option for     LAL Deficiency patients.   "
116794|NCT01757171|"     Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard     administration dose and schedule. This application is a non-labeled indication for     cabazitaxel and will inform future drug development in gastroesophageal malignancies, where     docetaxel remains an approved first line agent, but is not routinely used due to excessive     toxicity and marginal efficacy.      At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel     in refractory gastric cancer, with preferential activity in one or more gastric cancer     subtypes   "
116795|NCT01757158|"     The primary curative treatment of lung cancer patients is surgery, chemotherapy and/or     radiation therapy (either or all depending on the extent of disease). Surgical resection     usually requires removal of a lobe of the lung (lobectomy). There are, however, some patients     who are unable to have a lobectomy. There are several reasons why a patient should not have a     lobectomy including prior operations in the same area of the lung or poor lung functions.     Sub-lobe operations (less than a full lobectomy), are alternatives for these patients. Types     of sub-lobe operations include wedge resection or segmentectomy.      However, a randomized trial in early stage lung cancer patients that compared lobectomy     versus wedge resection showed worse local control of cancer with wedge resection. Therefore,     localized disease wedge resection is considered an inadequate operation. This inadequacy can     be compensated if radiation seeds are added to the site of wedge resection. Iodine-125     (I-125) is the most commonly used radiation seed for this purpose. I-125, however,     unfortunately has a relatively long half life (time taken for activity to become half) of 2     months. Therefore, the patient is technically 'radioactive' for an average of 6 months to 1     year. This can seriously compromise quality of life.      Cesium-131 is another radiation seed that may more effectively treat lung cancer patients.     Cs-131 has been previously used in prostate cancer successfully. Cs-131 has similar energy to     I-125 but has a much shorter half life (9days as compared to 60 days for I-125). Patients who     receive Cs-131 radiation seeds are expected to be radioactive for 30 days (1 month) as     compared to 180 days (6 months) with I-125. The objective of this study is the use Cs-131     radiation seeds in lung cancer patients who are planning to undergo a wedge resection for     localized disease and follow the patients for cancer control and toxicity. These results will     be compared to pre-existing data for I-125 treatment outcomes in lung cancer patients who     have had a wedge resection for localized disease.   "
116797|NCT01757132|"     The objective of the PAS-01 study is to assess the safety of the intraocular as measured by     the cumulative incidence of patients who within 5 years after implantation experience     persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best     corrected distance visual acuity >2 lines from pre-surgery baseline level).      The study will test the null hypothesis that the percentage of patients who experience     persistent vision-impairing corneal edema is >17% against the alternative that the percentage     is <17%. The null hypothesis will be rejected if the upper bound of the two-sided 95%     confidence integral for the observed percentage is <17%.   "
116798|NCT01757119|"     The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of     iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous     sulphate) in women with iron deficiency anaemia.   "
116799|NCT01757106|"     Purpose of this study is to test whether xenon application during off-pump-coronary artery     bypass (OPCAB)-surgery is safe and feasible.   "
116800|NCT01757093|"     The purpose of this study is to compare the oxygen consumption and energy expenditure during     the spontaneous breathing trial.   "
116801|NCT01757080|"     OBJECTIVE: To analyze the influence of lipid control during a cardiorespiratory exercise test     in two subgroups. DESIGN: Parallel trial study. PARTICIPANTS: The sample consisted of 40     elderly people, male and female, divided into two groups: 20 hypertensive (G1; 68.50 ±5.85     years) and 20 diabetic-hypertensive (G2; 68.95 ±6.79 years). MEASUREMENTS: Nutritional     status; glucose and lipid controls - postprandial glucose (PPG), triglycerides (TG), total     cholesterol (TC), low density lipoprotein (LDL-C), very low density lipoprotein (VLDL-C),     high density lipoprotein (HDL-C); blood pressure, and cardiorespiratory performance. The     significance level was set at p<0.05.   "
116802|NCT01757067|"     Premature ventricular contractions (PVC) are a very common irregular heart beat (arrhythmias)     even in patients without heart disease. Frequent PVCs are thought to occur in about 1-4% of     the general population. Many patients with PVCs complain about skipping of their heart     (palpitations), shortness of breath and feeling tired. In some patients PVCs may also result     in weakening of the heart muscle (heart failure), which might be reversible with suppression     of the PVCs.   "
116803|NCT01757054|"     The main hypothesis of this study is that there will be a significant increase of     Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy     humans following daily consumption of a probiotic supplement containing these specific     strains of probiotic bacteria.   "
116804|NCT01757041|"     Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide.     Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal     sepsis (EOS, in <7 days of life) in sSA. In other regions, maternal carriage is associated     with early onset neonatal sepsis, but in addition, other adverse perinatal outcomes     (stillbirths, early neonatal death, low birth weight and prematurity). Robust data on     maternal GBS carriage in sSA and its burden on adverse perinatal outcomes are lacking, with     important consequences for public health interventions.      Through investigation of maternal carriage and perinatal outcomes at three different sites:     rural, semi-rural and urban, this study will provide a comprehensive description of the     burden of GBS in coastal Kenya, informing public health policy and driving forward     interventions. Risk factors for maternal colonisation and invasive neonatal disease will be     assessed, including through retrospective immunological investigation of cord blood in     neonates subsequently identified as having invasive GBS disease or other adverse perinatal     outcomes, compared to those without.      GBS isolates from maternal colonisation will be typed (sero-typing and molecular analysis),     and these isolates will be compared to existing archived neonatal isolates from investigation     of neonatal sepsis in KDH (Kilifi District Hospital). This is important so that we know the     prevalent sub-types causing neonatal disease in Kenya, those which are carried by mothers,     and therefore whether maternal GBS carriage correlates with a high risk of perinatal disease.     GBS vaccines in development are type-specific and this will inform their use in sSA.      Stillbirths will also be investigated, in individual cases, through additional detailed     microbiological and other laboratory investigations to make an assessment of the contribution     of GBS to stillbirths in Kenya.   "
116841|NCT01756547|"     Study to assess the efficacy and safety of oral potassium citrate on the Prevention of     nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo     controlled trial.   "
116842|NCT01756534|"     This single-blind prospective randomized study was designed to assess the efficacy and safety     of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures     and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery   "
116805|NCT01757028|"     Improving maternal and infant mortality are key priorities in Kenya and internationally. This     study aims to establish a hospital-based surveillance system for pregnant women so that the     contribution of risk factors (HIV and other infections, maternal nutrition, sepsis, malaria     and anaemia) to maternal and infant morbidity and mortality can be accurately assessed. All     mothers who are admitted to Kilifi District Hospital will be invited to enrol in the study.     Routine clinical data from maternal admissions for delivery will be systematically collected     using a standardised admissions procedure. Analysis will be carried out for the risk factor     effects of HIV, maternal nutrition, malaria infection, bacterial infection, and anaemia on     maternal and infant outcomes after adjusting for other factors (mode of delivery, age, and     parity etc). Subsequent morbidity and survival of mothers and infants, and the later     consequences to children's health will be monitored through the Kilifi epi-DSS. Samples for     research purposes will be collected for detailed future studies of particular pathogens and     risk factors, such as malaria parasite strain, bacterial species and HIV-induced     immunological impairment. This will be the first prospective study in sub-Saharan Africa     (sSA) to assess the effect of these risk factors on both maternal and infant health together,     and that considers both short and long term outcomes. Information generated by the study will     be used by the maternity department in a rolling audit that will help improve care. The study     will therefore improve care of new mothers and infants attending the Kilifi District Hospital     as well as informing health planning so that future interventions for maternal and child     health are targeted more effectively.   "
116806|NCT01757015|"     This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.)     via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status     and is well tolerated compared to placebo in symptomatic COPD patients with moderate to     severe airflow limitation who are already receiving maintenance therapy with inhaled     fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.)     via multi-dose dry powder inhaler (MDDPI).   "
116956|NCT01755039|"     The purpose of the study is to determine the frequency and management of respiratory     incidence in patients with invasive out-of-hospital ventilation, either living at home for     elderly people allay to a weaning centre or at home. Further, the mortality and the frequency     of hospital admission will be analyzed.   "
116807|NCT01757002|"     The purpose of this study is to evaluate the Puff City web-based behavioral intervention of     asthma management program in a clinical setting. This study also examines and evaluates the     cost and efficiency of patient eligibility determination methods, patient recruitment, study     monitoring (compliance with study regimen, participant retention and follow-up), and the     collection of clinical endpoints.   "
116808|NCT01756989|"     The purpose of this study is to determine whether initial local irradiation with topotecan     and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective     in the treatment of pediatric diffuse brainstem tumor.   "
116809|NCT01756976|"     This study is intended to provide additional performance data of the OrthoPAT Advance in     routine orthopedic surgery.   "
116810|NCT01756963|"     In addition to a genetic susceptibility, the immune system and the intestinal microbiota,     diet is hypothesized to be an important factor in the onset and progression of Inflammatory     Bowel Diseases (IBD). Further insight in factors affecting disease activity may contribute to     targeted interventions improving disease burden and healthcare costs for these patients.     However, well-designed studies exploring the role of diet in the development of exacerbations     are hardly available.      The investigators hypothesize that differences in dietary patterns affects the intestinal     microbiota composition and thereby contributes to the development of exacerbations in IBD.      Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence     is unknown since simple noninvasive screening tools have not been validated for IBD. The     investigators hypothesize that malnutrition is frequently present in IBD patients and     associated with dietary intake and disease characteristics.   "
116811|NCT01756950|"     The purpose of this study is to assess in healthy subjects the safety, tolerability,     pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal     antibody against influenza A viruses.   "
116812|NCT01756937|"     Efficacy and safety of Imotun capsule in osteoarthritis of the knee   "
116813|NCT01756924|"     To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe     as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint     or spacer infections   "
116814|NCT01756911|"     Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm     Repair.      The objectives of the study is to determine the efficacy, safety and performance of the MFM     and its delivery system in patients at high surgical risk presenting with a type II, III     thoracoabdominal aneurysm, below the left subclavian and above the iliac bifurcation,     according to the Crawford classification.   "
116815|NCT01756898|"     The purpose of this research study is to gather scientific information about the     effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult     subjects with atopic dermatitis.   "
116816|NCT01756885|"     Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke     following diagnosis and treatment. With medical advances in cancer care yielding a growing     constituency of cancer survivors, addressing nicotine dependence in this population is a     priority. While PHS guidelines recommend acute treatment durations with approved medications     for tobacco use, extending the duration of treatment beyond the standard treatment duration     significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to     abstinence following a lapse. Varenicline may be particularly effective for cancer patients     given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer     patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks     placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize     that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed     abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in     the extended therapy group versus the standard therapy group, and there will be no     significant differences between groups in terms of severe side effects, and 3) Improved     affect and reduced cognitive impairment will mediate the effect of extended therapy on quit     rates.   "
116843|NCT01756521|"     The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy     male subjects. Moxifloxacin is a positive control drug used in QT study. In this study,     moxifloxacin 400mg and 800mg will be used, to get information on effect of moxifloxacin on     QT/QTc interval.   "
116844|NCT01756508|"     Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.   "
116817|NCT01756872|"     The purpose of this study is to find out more about tests used to estimate the number of eggs     a woman has remaining in her ovaries (her 'ovarian reserve'). It is thought that women who     have a greater number of eggs or ovarian reserve may have a better chance of successful in     vitro Fertilisation (IVF) treatment than those who have a smaller number of eggs. Accurately     predicting the likely outcomes of IVF would be of great benefit for counselling patients     before they go through expensive and demanding treatments such as IVF and IVF with     Intracytoplasmic sperm injection (IVFICSI).      Over the past two decades, many endocrine and ultrasound markers have been designed and are     now used as indicators of ovarian reserve. A number of screening tests are utilized to     measure these markers, either by ultrasound scanning techniques or taking blood samples.     However it is not yet known which, if any, best predict the outcome of IVF treatment. We     would like to investigate these various measures of ovarian reserve to determine which are     most accurate, particularly for predicting live birth rates, as up to now only poor to     moderate quality evidence has been available for this outcome.      This will be a prospective cohort study of 300 women who already intend to undergo     IVF/IVF-ICSI treatment. Study participants will have one extra blood sample and ultrasound     examination, for the purposes of measuring markers of their ovarian reserve, at the start of     their IVF/IVFICSI treatment cycle. No other interventions will be required and their     treatment cycle will not be affected by their participation in the study.   "
116827|NCT01756742|"     Pleural effusion and the complexity of diagnosis and treatment make planning and delivering     care challenging. Respiratory physiotherapy is recommended, and should be applied during the     first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of     a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a     University Hospital.   "
118062|NCT01740609|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     immunogenicity of single escalating doses PF-06342674.   "
116818|NCT01756859|"     Death from chronic liver disease has doubled in the UK over the last decade. This is largely     due to the rise in liver disease from excess alcohol consumption, obesity related fatty liver     disease and hepatitis B & C infections. The current 'liver tests' only identify liver injury     when the damage is at an advanced stage. They neither estimate the degree of injury     accurately nor help judge prognosis. The complications from chronic liver disease result     mainly from raised pressures within the liver. We currently measure this pressure by passing     a long catheter through the jugular vein in the neck into the liver. This invasive test does     carry a small yet significant risk of complications and is not available outside specialised     liver centres. Raised pressure within the liver is also associated with changes in the     microorganisms within the gut. This leads to increased infective complications among patients     with liver cirrhosis.      We aim to noninvasively measure the pressures within the liver using Magnetic Resonance     Imaging (MRI). We will recruit 49 patients with chronic liver disease who have had liver     pressure measurements as part of their routine clinical assessment. The participants will     attend the Biomedical Research Unit and the MR Centre for a single 2hour visit. We will also     collect blood, urine and stool samples from them.      The diagnostic accuracy of the quantitative MRI techniques will be validated against the     pressures obtained via the invasive test. The quantitative MRI techniques will also     correlated with biomarkers of liver injury obtained from blood and urine samples. The stool     sample obtained will be used to characterise the gut microorganisms in these patients.   "
116819|NCT01756846|"     Aim of this study is to quantify the impact of the use of the HEART risk score on patient     outcome and on costs in patients with chest pain presenting at the emergency room, as     compared to not using the score.   "
116820|NCT01756833|"     The primary aim of this study is to determine if doxycycline (100 mg bid) will inhibit (by at     least 40%) the increase in greatest transverse diameter of small abdominal aortic aneurysms     (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison     to a placebo-treated control group.   "
116821|NCT01756820|"     The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel     Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®,     Stryker) are equally effective and safe surgical options for the treatment of primary Carpal     Tunnel Syndrome.   "
116822|NCT01756807|"     Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical     Coherence Tomography: the COMBO Stent angiographic extension Study (EGO-COMBO angiographic     extension Study)   "
116823|NCT01756794|"     The purpose of this study is to validate a strategy of identification of patients for early     liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is     very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J     Med 2011) that liver transplantation may be an option in very carefully selected patients who     did not respond to medical treatment. This selection process deserves to be confirmed in a     population of greater size. We hypothesized that patients selected with this process would     have a same alcohol relapse rate after liver transplantation than patients transplanted for     alcoholic cirrhosis and selected using a 6-month sobriety period   "
116824|NCT01756781|"     This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of     midazolam in adult healthy women of non-childbearing potential when administered alone and     when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be     randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in     treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2.     Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in     treatment period 1, and following a washout period of no less than 14 days they will receive     midazolam alone in treatment period 2.   "
116825|NCT01756768|"     This will be an open-label, single-center study to evaluate the mass-balance and     pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single     oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of [14C]-PD-0332991.     Subjects will be checked in to the research unit from approximately 12 hours prior to dosing     and remain in house until greater than 90% of the administered radioactivity is collected     from bodily excreta or until less than 1% of the administered radioactivity is recovered from     excreta on consecutive days. This study will investigate the extent of involvement of the     renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the     compound's major metabolites.   "
116926|NCT01755429|"     This protocol is intended to formally collect data on the treatment of aHUS with eculizumab     in Japanese patients.   "
117439|NCT01748734|"     The purpose of this study is to learn about treatment of depression in people who have any     type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting     patient's thoughts and behaviors. People who are depressed tend to have more negative or     pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By encouraging     patients to develop more balanced views, symptoms of depression begin to improve   "
116826|NCT01756755|"     Despite maintaining adequate mean arterial pressure and central venous oxygen saturation, the     mortality is still high in severe sepsis and septic shock. Previous studies have demonstrated     that derangements in microvascular flow play a role in sepsis-induced multiple organ     dysfunction and death. Lipopolysaccharide (LPS) or endotoxin is a specific ligand for     Toll-like receptor 4 (TLR4), it can induce the following reactions including excessive immune     and inflammatory responses , oxidative stress , capillary leakage, endothelial damage,     impaired arteriolar and venular vasoregulation, and activation of the coagulation cascade 8.     Subsequently, these reactions can lead to microcirculatory dysfunction. Polymyxin B adsorber     hemoperfusion (PMX) have been proved to reduce mortality of severe sepsis and septic shock.     Since 1994 to 2007, more than 60,000 patients have received this treatment. In a systematic     review, the results show that PMX therapy was associated with significantly lower mortality     risk (risk ratio, 0.53; 95% CI, 0.43 to 0.65). In a prospective, multicenter, randomized     controlled trial (Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis [EUPHAS]), the     results show that SOFA scores improved in the polymyxin B group, and 28-day mortality was 32%     in the polymyxin B group and 53% in the conventional therapy group.      The investigators hypothesize that polymyxin B hemoperfusion can decrease blood endotoxin     level and reduce endotoxin-related microcirculatory dysfunction. The purpose of this     prospective, multicenter, randomized, controlled, open study is to investigate the effect of     polymyxin B hemoperfusion on the sublingual microcirculation in patient with proven or     suspected gram-negative bacteria severe sepsis and septic shock. The mean arterial pressure,     dose of vasopressors and inotropics, SOFA score, PaO2/FiO2 ratio, and 28-day mortality will     be investigated.   "
117087|NCT01753336|"     The purpose of the protocol is to assess the long term safety of repeat treatment cycles of     Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an     extension study to study A-TL-52120-169 (hereafter referred to as Study 169).   "
116828|NCT01756729|"     This is a non-randomized, concurrent control study, designed to confirm that the efficacy of     the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings     following approval is comparable to that of BSC chemotherapy patients. The device is a     portable, battery operated device that was approved for the treatment of adult patients (22     years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following     histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the     brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and     is intended as an alternative to standard medical therapy for GBM after surgical and     radiation options have been exhausted.   "
116829|NCT01756716|"     The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and     pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and     Moderately Decreased GFR   "
116830|NCT01756703|"     The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and     pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria   "
116831|NCT01756690|"     A certain molecule floating in the blood may represent a risk of lung injury after a     transfusion. We are determining whether detection of this molecule on a simple blood clotting     test will predict the development of lung injury due to transfusion in bleeding patients with     chronic liver disease.   "
116832|NCT01756664|"     - The use of sunscreen on the first day after fractional ablative skin resurfacing may reduce     the risk of post-inflammatory hyperpigmentation   "
116833|NCT01756651|"     The purpose of this study is to assess the safety and efficacy of intranasally-administrated     fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of     a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the     urine, urinary complaints or any other problems with the urinary bladder). The current     standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to     lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used     to reduce pain that occurs during and after the above procedure.   "
116834|NCT01756638|"     The purpose of this study is to investigate safety and efficacy of abiraterone in     participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not     received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).   "
116835|NCT01756625|"     PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective     cohort study and with independent investigators. The purpose is to compare PFS in real life     with PFS clinical trials and to determine factors impacting efficacy and compliance to     cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.   "
116836|NCT01756612|"     This prospective, multicenter, observational study will evaluate the impact of comorbidity     factors on the hemoglobin level in participants with chronic kidney disease who are not on     dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera).     Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin     beta treatment.   "
116837|NCT01756599|"     Regular advances in cancer treatment have dramatically improved the prognosis of children and     adolescents with acute leukemia (AL), raising with a great acuity the problem of the late     physical side effects, social integration, quality of life of the patients and their family     as well as identification of the determinants of these outcomes. Large nationwide and     international cohorts developed in general population (I4C, EPIC ELF…) are restricted to the     study of childhood cancers occurrence. In addition, the national registries (French,     European) of childhood cancers are designed to evaluate incidence and mortality, but not to     produce individual detailed data on the follow-up and outcome of these children. Answering     these questions supposes a comprehensive multidisciplinary approach resting on prospective     cohorts of cancer survivors, specifically exploring the outcome of these children. These     cohorts allow to identify prognostic factors of the health condition and social integration,     and to propose adapted strategies of follow-up. The Childhood Cancer Survivor Study (CCSS),     which remains the most important study, only concerns the North-American populations and     rests on a self-reported follow-up assessment. In France, the LEA study, initiated in 2004     could answer some of these questions, but the representativeness and the size of the     population (study initially limited to two areas PACA-Corsica and Lorraine) remain     insufficient to study uncommon events. Similar approaches are conducted in Europe trough the     broad collaborative Pancare network, to which the LEA program is associated.   "
116838|NCT01756586|"     Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on     lower extremity blocks. The study would evaluate that point.   "
116839|NCT01756573|"     Effect of dexamethasone on prolonging upper extremity block is well known. But it not known     if the effect comes from its local effect on the nerves or from its general analgesic effect.     In this study we will compare the systemic effect to its local effect to find out if there is     a difference or not.   "
116845|NCT01756495|"     This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy     adult subjects. The purpose of this study is to characterize the effect of orally     administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac     repolarization as measured by the corrected QT interval (QTc) duration, compared with placebo     and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a mild QTc     interval prolongation; therefore, it will serve as a positive control to validate the ability     of this study to detect a change in the QTc interval. All subjects will participate in 4     study periods separated by a minimum washout period of 5 days. Each subject will receive one     of 4 regimens (A = Losmapimod 7.5 milligram [mg] Twice daily [BID] x 5 days, B = Losmapimod     20 mg Once daily [QD] x 5 days, C = moxifloxacin 400 mg on Day 5, D = Losmapimod matched     placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study periods in a     randomized, cross-over fashion. Subjects will be assigned to one of four treatment sequences     following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit will occur 10 to 14     days after end of Period 4   "
116846|NCT01756482|"     This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a     strain of Respiratory Syncytial Virus.   "
117088|NCT01753323|"     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria     patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400     mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)   "
116847|NCT01756469|"     The main study objective is to investigate whether female sex workers (FSWs) at drop-in     centers in Mombasa, Kenya, who report harmful or hazardous alcohol intake and participate in     a brief alcohol intervention (vs. those who participate in a nutrition intervention in the     control group), will reduce their alcohol use and incidence of STIs, HIV, and sexual     violence, as well as increase their condom use.   "
116848|NCT01756456|"     This study is aimed at assessing the safety and the efficacy of two dose regimens of     recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for     inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer)     neurotrophic keratitis   "
116849|NCT01756443|"     Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of     ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a     better safety profile as the injection of local anaesthetic is performed under direct vision.     This has allowed a reduction of the amount of local anaesthetic injected as compared to     peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous     nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of     local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a     long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but     of a consistently shorter duration compared to a long acting local anaesthetic alone. We     hypothesize that sequential perineural injection of lidocaine and bupivacaine provides     similar onset but a longer duration of sensory block compared to the same dose and volume of     local anaesthetic mixed in advance.   "
116850|NCT01756430|"     The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus     Carvedilol IR in Patients With Essential Hypertension   "
116851|NCT01756417|"     The purpose of this study is to investigate whether there is a drug-drug interaction between     multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and     tolerability of canagliflozin will also be assessed.   "
116852|NCT01756404|"     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the     drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of     canagliflozin (JNJ-28431754) in healthy obese volunteers.   "
116853|NCT01756391|"     Asthma is a disease that affects more than 12% of Americans under the age of 18 for over 14     million missed school days per year, and is the number one cause of school absences in     America. Elementary school children spend 6 to 10 hours a day in school, and most of that     time is spent in one classroom. The goals of this project are to provide an understanding of     exposure risk factors specific to the classroom. This is critical, because the classroom     environment could potentially be considered as an effective target for prevention of     inner-city asthma morbidity by reducing exposures to many symptomatic children through an     intervention in the school classrooms.   "
116854|NCT01756378|"     we tested the effect of adding the mobilization with movement to the traditional physical     therapy program on pain, ROM and functional disability in patients with knee OA.      study hypothesis: there will be no significant difference between traditional physical     therapy program and the mobilization with movement plus the traditional physical therapy     program on pain, ROM and functional disability in patients with knee OA   "
116855|NCT01756365|"     The study  Autologous cultured corneal epithelium (CECA) for the treatment of unilateral     corneal lesions associated with limbal stem cell deficiency is the first clinical trial of     this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives     to produce a reconstructed tissue with the therapeutical aim of treatment of unilateral     limbal stem cell deficiency (only one eye is affected by the limbal stem cell deficiency).     The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the     CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.   "
116856|NCT01756352|"     Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET     will predict durable benefit in patients receiving anti-angiogenic benefit for presumed     recurrent GBM (i.e. progression-free survival and overall survival). We have defined one     primary specific aim, for which we expect to obtain definitive results, and two secondary     aims, under which we plan to generate preliminary data to support a future, larger project.   "
116857|NCT01756339|"     This study will evaluate the safety and efficacy of an experimental antibiotic,     solithromycin, in the treatment of adult patients with community-acquired pneumonia.   "
116927|NCT01755416|"     Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control     system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic     excursions than insulin mono-therapy.      Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition     of Liraglutide compared to insulin mono-therapy.      Study Design: This is a randomized open labeled crossover design trial comparing adjuvant     Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for     insulin delivery.   "
116928|NCT01755403|"     o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic     Chagas Disease to get information to optimize drug doses.   "
116874|NCT01756118|"     Primary objectives:        -  To establish the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D)          of BEZ235 when administered twice daily (BID) as a single agent in patients with          relapsed or refractory acute leukemia        -  To determine the dose-limiting toxicity (DLT)      Secondary objectives:        -  Assess the safety and tolerability of daily oral administration of BEZ235 with a BID          schedule        -  To describe preliminary anti-leukemic activity of BEZ235 in patients with acute leukemia        -  To correlate changes in pharmacodynamic biomarkers with basic pharmacokinetic data      Exploratory objectives:        -  To assess pre-treatment phosphatidylinositol 3-kinase (PI3K) pathway-related genes in          blast cells and all other malignant cells derived from blood or bone marrow.        -  To assess the pharmacodynamic changes in components of the PI3K-protein kinase B          (AKT)-mTOR pathway in bone marrow following treatment as potential predictive biomarkers          of pharmacodynamic (PD) activity of BEZ235 in association with clinical responses.        -  To identify potential resistance mechanisms and biomarkers that may correlate with          efficacy and response from blood and bone marrow samples pre-and post-treatment in case          of resistance   "
116858|NCT01756326|"     Fracture healing is a complex physiological process caused by interaction of cellular     elements, cytokines and signaling proteins, which results in the formation of new bone     (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other     factors, 10% of all fractures will eventually fail to unite.      Non-union fractures are defined as fractures that are at least six to nine months old and in     which there have been no signs of healing for the last three months. Various causes have been     evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including     poor fracture stabilization, local infection and failure of the osteoblastic cells to     multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions,     is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and     external fixation devices (Kanakaris et al., 2007). This procedure produces good results but     requires an invasive surgery of several hours under general anesthesia and a few days of     hospitalization. Because of this, major complications have been reported in up to 20-30% of     patients (Pieske et al., 2009, Zimmerman et al., 2009).      This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary     population of autologous osteoblastic cells, in the treatment of hypotrophic non-union     fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority     design.   "
116859|NCT01756313|"     The objectives of this study is to investigate if pre-treating the skin with an ablative     fractional laser that creates small micropores in the skin:        1. Increases the uptake of Methylaminolevulinat (MAL) in the skin.        2. Decreases the required incubation time of MAL when performing photo dynamic therapy.   "
116860|NCT01756300|"     The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility     study to evaluate the safety and effectiveness of the investigational multi-electrode     ablation catheter and integrated ablation system to treat resistant hypertension.   "
116861|NCT01756287|"     To assess whether Chinese ocular exercise is effective in altering distant and near visual     acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the     possibility of slowing myopia progression in teenager through a weak but long-term effect.   "
116862|NCT01756274|"     The purpose of this study was to evaluate the performance of three Bayer Blood Glucose     Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were     'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a     tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with     capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000     instrument).   "
116863|NCT01756261|"     The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL).     The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of     National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline     and at the 6 and 12 months after start of EYLEA treatment.   "
116864|NCT01756248|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received EYLEA for Age-Related     Macular Degeneration (AMD).      The objective of this study is to assess safety and effectiveness of EYLEA using in real     clinical practice.      A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational     period. An annual follow-up survey will be conducted for 5 years at the longest after     standard observational period.   "
116865|NCT01756235|"     The purpose of this study was to evaluate physical activity and its changes in participants     with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.   "
116866|NCT01756222|"     The purpose of this registry is to gather information on patients with bicuspid aortic valve     disease.   "
116867|NCT01756209|"     Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or     acetaminophen for the acute treatment of primary migraine in children in or out prophylactic     treatment with magnesium.      Methods: The study had been approved by the Researchers Ethics Committee of the     Pugliese-Ciaccio Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the     children ranging from the ages of 5 to 18 years with at least four attack/month of primary     migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the     moment of admission to the study (start of the study) and every month up to 18 months later     (end of the study).   "
116868|NCT01756196|"     Many systemic reactions occur commonly after spinal steroid injections, especially in     patients, and may be associated with underlying disease, such as hypertension and diabetes     mellitus, as well as steroid dose and repetition of spinal steroid injection.   "
116869|NCT01756183|"     Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the     Patients with Unresectable Gastric Cancer   "
116870|NCT01756170|"     This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II     b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater     toxicities but similar survival rate as those treated by radiotherapy alone.   "
116871|NCT01756157|"     The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of     two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by     subcutaneous (SC) injection to prevent angioedema attacks.   "
116872|NCT01756144|"     When there is a bone defect, bone transport is used to bridge the defect. Frequently, the     bone in the docking site (where the transported bone comes together) doesn't heal.      The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in     order to find new techniques to treat non-union of long bones.      The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous     bone grafting in stimulating bone healing in the docking site.   "
116873|NCT01756131|"     A single dose escalation study to determine the safety, tolerability, and pharmacokinetic     profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral     (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and     follow-up evaluations for a minimum of 12 weeks following the injection.   "
116939|NCT01755260|"     The aim of this study is to compare the closure rate of pancreatic fistula (PF) after     pancreaticoduodenectomy (PD) under various types of nutrition.   "
117089|NCT01753310|"     The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL     dilution compared with placebo for the treatment of Cervical Dystonia.   "
116875|NCT01756105|"     Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading     to fetal and maternal complications which may be prevented by reaching very strict glycaemia     targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence     is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because     criteria of screening have been strengthened after the results of last studies. Usual     treatment is diet and in case of failure insulin therapy with multiple injections which may     lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some     studies have shown the comparable effect of metformin and insulin in about 50% of GD obese     patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and     fetus and baby of metformin. In case of metformin failure, insulin will be added in order to     obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby     umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress     compared between insulin and metformin alone treated patients.   "
116876|NCT01756092|"     The investigators will assess changes in breast appearance, graft retention and quality of     life over one year in patients who have received direct autologous adipose tissue injection     for the treatment of objectionable post-surgical breast deformities. These patients have     undergone the resection of breast tissue to treat either benign or malignant breast disease.   "
116877|NCT01756079|"     This study is being done to find out if the addition of boceprevir to standard of care (SOC)     treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for     participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not     successfully treated by previous SOC. All participants will receive treatment with SOC alone     for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional     weeks of combined treatment.   "
116878|NCT01756066|"     To test the uptake of four different cost sharing discounts for enrolling in the Weight     Watchers weight loss program as well as outcomes (program attendance and weight loss) over 12     months.   "
116879|NCT01756053|"     This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089     (an experimental medication not approved by the FDA) when administered as 40mg oral once     daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive     deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit     attempt (~4 days). The key cognitive domains include: working memory, sustained attention,     and response inhibition.   "
116880|NCT01756040|"     Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency     characterized by increased intestinal permeability, affects approximately 7 to 10% of infants     <1500 g birthweight, and typically occurs within 7 to 14 days of birth. Mortality is as high     as 30-50%. Prematurity is the greatest risk factor for the development of NEC due to the     physiological immaturity of the gastrointestinal tract and altered or abnormal gut     microbiota. Several studies have demonstrated that the initiation of an intense systemic and     local inflammatory cascade leads to intestinal necrosis. The human intestine is lined by a     single layer of cells exquisitely responsive to multiple stimuli and is populated by a     complex climax community of microbial partners. Under normal circumstances, these intestinal     cells form a tight but selective barrier to friends and foes: microbes and most     environmental substances are held at bay, but nutrients are absorbed efficiently. Epithelial     barrier integrity is itself dynamic and matures over time starting soon after birth, though     the mechanisms regulating dynamic permeability are poorly understood. Low birth weight,     prematurity, and early postnatal age are associated with a leaky gut. Although intestinal     permeability is higher at birth in preterm than term infants, there is usually rapid     maturation of the intestinal barrier over the first few days of life in both populations. The     investigators hypothesize that increased levels of measures of intestinal permeability (serum     zonulin, urine lactulose/rhamnose (LA/Rh), and fecal alpha1- antitrypsin will identify     infants at high risk for NEC. The purpose of the study is to determine whether measurement of     intestinal permeability in serum will correlate with other markers of intestinal barrier     leakiness measured in urine (LA/Rh) and stool (alpha-1 antitrypsin. If there is good     correlation, then zonulin or serum rhamnose may be a useful measure to identify preterm     babies at risk for NEC.   "
116881|NCT01756027|"     Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy     treatments on the cheeks, depending on their assigned study group. Follow-up visits will     occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60     min post-treatment, and at each follow-up visit.   "
116882|NCT01756014|"     The investigators will evaluate the determinants of cerebral impairment in patients with     non-ischemic heart failure compared to controls, and its relation to cognitive function. They     hypothesize that patients with heart failure have impaired brain perfusion and hemodynamic     factors are associated with cognitive dysfunction.   "
116883|NCT01756001|"     This randomized control trial will explore interventions to promote medication adherence     using a novel electronic device that can track daily pill use. 500 subjects will be     randomized into 4 arms of the experiment. In addition to a control arm, our three arms will     be: reminders, financial incentives, and reminders and financial incentives.   "
116940|NCT01755247|"     This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000     with and without the application of a commercially available moisturizer in approximately 15     healthy subjects. The test product will be applied to the forehead of healthy volunteers once     daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15     minutes after the test gel was applied and one group of subjects will be treated with the gel     vehicle which does not contain the active product. The hypothesis is that the application of     moisturizer will not effect safety or local tolerability.   "
116884|NCT01755988|"     The number of people with heart failure is increasing in the western world. Mainly due to     better treatment of myocardial infarctions and ageing of the population. The amount of health     care workers is unfortunately not increasing. We want to investigate how two electronic     devices (a website and an interactive web-based platform) influence the self-care, quality of     life, hospitalizations and mortality by delivering care from a distance. We also want to     investigate if a higher quality of care is delivered despite of less frequent visits to a     nurse and/or doctor. The study takes place in the Netherlands and is a randomized trial.     Patients with heart failure, registered by an outpatient heart failure clinic or general     practitioner can take part. They will be randomized to 3 groups: group 1 receives standard     care, group 2 receives standard care with the website, group 3 receives an adjusted care     pathway, with both the website and the interactive web-based platform connected to a     telemonitoring system. In this group all routine consultations with heart failure nurses and     general practitioner will be substituted by this device.   "
135138|NCT01515995|"     The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as     a vehicle for albuterol in children with moderate to severe asthma exacerbation.   "
116885|NCT01755975|"     The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well     or they may only work for a short period of time. This is why new treatments are being     tested.      This study will test a new combination of two drugs that are already approved by the Food and     Drug Administration for treatment of certain kinds of blood cancers. These drugs are     romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma     or multiple myeloma. However, while these drugs are routinely used alone, this is the first     time they will be tested together. The mechanism of action of both drugs is not well     understood but both have been shown to to be effective by themselves in lymphoma and multiple     myeloma.   "
116886|NCT01755962|"     This project is prompted by the urgent public health need to identify novel strategies to     prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD,     T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore,     finding optimal intervention strategies to combat these growing epidemics is imperative.   "
116887|NCT01755949|"     Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the     rise in CRP which occurs following atrial fibrillation ablation   "
116888|NCT01755936|"     Aortic stenosis is the most common adult valvular heart disease in the western world. Heart     failure and sudden cardiac death are complications associated with aortic stenosis. In     symptomatic individuals, valve replacement is often the only effective treatment. However,     there are no good markers to identify patients who may benefit from early surgery before     symptoms developed. The purpose of the study is to test the hypothesis that the presence     heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome     in patients with aortic stenosis, and thus may be helpful in identifying patients for early     valve replacement.   "
116889|NCT01755923|"     Gefitinib, the first EGFR-tyrosine kinase inhibitor (TKI) in the world was examined as     monotherapy in two phase Ⅱ studies called IDEAL trials. Response rate with doses of 250mg and     500mg/day were similar, ranging from 10% to 18%. Posterior analysis demonstrated that     patients with EGFR mutation had an improved response rate (RR) to gefitinib compared to     wild-type patients (46% versus 10%). The early trials that evaluated EGFR-TKIs for the     second- and third-line settings of advanced NSCLC did not select patients on the basis of any     EGFR marker. The IEESSA Survival Evaluation in Lung Cancer (ISEL) trial evaluated the role of     second-line gefitinib 250mg/day in 1692 patients with advanced NSCLC. Patients with EGFR     mutations had higher RR than patients without (37.5% versus 2.6%). From the above results,     the response rate in patients without EGFR gene mutation was obviously different (10% versus     2.6%). The methods used for detecting EGFR gene mutation was different, which might     contribute to the difference of response rates. In IDEAL trial, EGFR gene mutation was     detected by sequencing. But in ISEL trial, EGFR gene mutation was detected by ARMS. As we     know, ARMS was more sensitive than sequencing in detecting EGFR gene mutation. That is to     say, in IDEAL trials some EGFR mutant patients were misdiagnosed as wild-type patients, so     the response rate was higher. Recently, Wu Yi-Long et al reported that relative abundance of     EGFR mutations predicted benefit form gefitinib treatment for advanced non small cell lung     cancer. The study cohort was all Chinese. In this study, the objective response rate in     patients without EGFR mutation detected by ARMS was 16.1%, which was significantly higher     than the response rate of docetaxel. But in 2012 American society of clinical oncology (ASCO)     annual meeting, the Tailor study in which Italian NSCLC patients were enrolled demonstrated a     clear superiority of docetaxel over erlotinib as second line treatment for patients without     EGFR mutations in exons 19 or 21. So we wonder if the racial difference is the determinant     factor. So the purpose of this trial is to compare the efficacy and safety of gefitinib with     docetaxel as second-line therapy for advanced or metastatic Chinese NSCLC patients with     wild-type EGFR.   "
116890|NCT01755910|"     The Left thoracic paravertebral block have a different effect on heart's autonomic nervous     system, as measured with Heart Rate Variability, compared to Right interscalene block   "
116891|NCT01755897|"     We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant     chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival     (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical     cancer patients with risk factors.   "
116892|NCT01755884|"     The aim of the study is to induce tolerance to wheat in wheat allergic children via oral     desensitization therapy. The hypothesis is that oral administration of wheat with increasing     dosing will increase the individual threshold for allergic reactivity to wheat protein (i.e.     desensitization) and even result in no reactivity (i.e. full tolerance). Along with this, the     risk for severe allergic reaction to wheat protein is minimized and the diet of patients can     partly or completely be normalized. In addition to clinical measures, the immunological     mechanisms of desensitization therapy are studied in detail at cellular and molecular level.   "
116893|NCT01755871|"     The purpose of this study is to explore immunomodulatory and immunosuppressive mechanisms of     action of fingolimod in patients with Relapsing remitting multiple Sclerosis to collect data     on biomarkers after initiation of fingolimod treatment.   "
116894|NCT01755858|"     The primary objective of this trial is to assess the effects of Bendavia on renal blood flow     and renal function in atherosclerotic renal artery stenosis (ARAS), compared with placebo in     patients with ARAS who receive one dose of study drug infused 30 minutes before and 3 hours     after percutaneous transluminal angioplasty of the renal artery (PTRA).   "
116895|NCT01755845|"     The purpose of this study is to determine the efficacy and safety of consolidation     chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical     hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage     cervical cancer.   "
116896|NCT01755832|"     The purpose of this study is to investigate the effects of heated pool group exercises for     patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue,     stiffness and ability to carry out daily activities).   "
131861|NCT01559051|"     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the health of patients with human Chronic     Obstructive Pulmonary Disease.   "
116929|NCT01755390|"     Primary Objective:      - To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of     XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive     weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment     cycle).      Secondary Objectives :        -  To define the safety profile of the drug        -  To establish the recommended dose and time interval for future Phase II trials        -  To determine the pharmacokinetic (PK) profile of XRP6258 in man        -  To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose          (following Protocol Amendment No. 2)        -  To look for evidence of antitumor activity   "
117062|NCT01753661|"     The purpose of the proposed exploratory research protocol is to investigate the feasibility     and efficacy of Project ASPIRE, a parent-directed intervention aiming to increase parental     skills and enrich children's early language environments and ultimately improve child     outcomes in children with hearing loss from low-income backgrounds.   "
116897|NCT01755819|"     Background:      Failure of graft incorporation and tunnel widening (TW) after anterior cruciate ligament     (ACL) reconstruction has been frequently reported in the literature. The etiology of TW is     still not fully understood.      Patients and Methods:      This is a prospective randomized study including 60 patients, conducted in a Level I trauma     center in Innsbruck, Austria. The study protocol was approved by the hospital ethics     committee. This study is planned and conducted following the Consolidated Standards on     Reporting Trials (CONSORT) guidelines. Aperture fixation is performed using BioComposite     interference screws (Arthrex, Naples, FL). Extracortical fixation is performed using the ACL     Tightrope (Arthrex, Naples, FL). TW is measured on CT scan postoperative, after 6 and 24     months. Clinical outcome is determined at 1, 2 after reconstruction, IKDC with KOOS     Knee-related QoL subscale, Lysholm, Tegner Activity scores, hop tests and KT-1000     measurements are performed.      Hypothesis:      The purpose of this randomized controlled trail is to determine the influence of two     different fixation methods on TW and clinical outcome after anatomic ACL reconstruction using     hamstring graft in young and active patients.   "
116898|NCT01755806|"     This study seeks to compare aortic dimension changes during cardiac cycle in patients with     and without aortic valve calcification and to evaluate its correlation with aortic valve     calcium score in former group.   "
116899|NCT01755780|"     The Left interscalene block has a different effect on heart's autonomic nervous system,     compared to Right interscalene block. This effect is evident on the occurrence of bradycardia     and hypotension during shoulder surgery in the beach chair position   "
116900|NCT01755767|"     The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating     patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already     been treated once with another therapy.   "
116901|NCT01755754|"     A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess     the functionality of female condoms with a silicone elastomer vaginal ring.   "
116902|NCT01755741|"     This trial will assess the potential impact of a vaginal ring on condom use by comparing the     performance (total clinical failure, clinical slippage, and clinical breakage) of a standard     male lubricated latex condom when the female partner is wearing the vaginal ring and when the     female partner is not wearing the vaginal ring.   "
116903|NCT01755728|"     There is a report that acetaminophen may have a role in pharmacological closure of PDA     (Patent arterial duct) in preterm infants.      The investigators conducted this open label non randomized and non control study to try to     support that report.   "
116904|NCT01755715|"     The main objective of this study is to compare, in a randomised, controlled and prospective     fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days)     versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception     one year after abortion.   "
116905|NCT01755702|"     This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and     an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.   "
116906|NCT01755689|"     The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals'     meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to     MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with     Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix     co-administered with Boostrix.   "
116907|NCT01755676|"     The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of     Obesity in adults.   "
116908|NCT01755663|"     Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.   "
116909|NCT01755650|"     The purpose of this study is to investigate the safety and potential effectiveness of the     imaging compound 18F FPM for finding sites of malignancies.   "
116910|NCT01755637|"     The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet     formulations manufactured under the different granulation processes in healthy Chinese adult     males.   "
116911|NCT01755624|"     The study is a prospective, randomly controlled phase II trial, designed to test the     efficacy, safety and neurocognitive outcomes of a medical device, the NovoTTF-100A, in the     treatment of NSCLC patients with controlled systemic disease, following optimal standard     local treatment for 1-5 brain metastases (BM). The device is an experimental, portable,     battery operated device for chronic administration of alternating electric fields (termed     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated     electrode arrays.   "
116912|NCT01755611|"     The aim of the study is to compare the bioavailability of two medications containing 100 mg     of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a     registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a     registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is     randomized, open, cross-over with two single administrations with two periods and two     sequences with a wash-out period of 7 days between the periods. Subjects in the study will be     25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66,     1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours     after medication administration in each period. Plasma minocycline levels will be determined     by HPLC method with UV detection with previously validated method. Minocycline concentration     data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The     log transformed pharmacokinetics parameters of test and reference medications will be     compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.   "
116913|NCT01755598|"     The purpose of this study is to evaluate the protective efficacy of two doses of GSK     Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy     will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because     pulmonary TB occurs frequently in these countries and age range. In addition, the safety and     immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of     volunteers.   "
117440|NCT01748721|"     This phase I trial studies the side effects and best dose of MORAb-004 in treating young     patients with recurrent or refractory solid tumors or lymphoma. Monoclonal antibodies, such     as MORAb-004, can block cancer growth in different ways. Some block the ability of cancer to     grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them   "
116914|NCT01755585|"     Radiation therapy (RT) is used as an effective local treatment modality to inhibit cell     proliferation, induce cell death and suppress tumor growth. To improve the treatment outcome,     in terms of both locoregional control and survival, the concurrent use of chemotherapy during     radiation therapy (CCRT) is now the standard treatment for various malignancies, especially     locally advanced cancers. Among the drugs used to enhance RT effect, 5-fluorouracil (5-FU) is     one of the most commonly used chemotherapeutic agents of CCRT.      In the past, RT was solely used as a local treatment and its effect was estimated by local     effect model. However, growing evidence shows that irradiation has direct DNA     damage-dependent effects as well as sending signals to neighboring cells. Recently, we     reported that abdominal irradiation could significantly modulate the systemic     pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the     daily treatment dose for target treatment in an experimental rat model. Additionally, the     results from a clinical investigation showed that colorectal cancer patients with lower AUC     of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these     lines of evidence support the importance and necessity to search for the mediators     responsible for the unexpected effect of local RT on systemic pharmacokinetics of     chemotherapeutic agents, such as 5-FU.      In the present study, the investigators investigated whether the phenomena and mechanism of     RT-PK is a fact for different anticancer drugs in human.   "
116915|NCT01755572|"     Purpose:      The purpose of this study is to further study the mechanism by which liraglutide, a     relatively new anti-hyperglycemic medication, might lower blood pressure in patients with     Type 2 diabetes and high blood pressure.   "
116916|NCT01755559|"     Study treatments:        -  Artemether-lumefantrine        -  Artesunate-amodiaquine        -  Dihydroartemisinin-piperaquine      Location:      Maradi, Niger      Principal Objective:      To measure the clinical and parasitological efficacy of the three artemisinin combination     therapies over a period of 42 days from the start of treatment and with polymerase chain     reaction assay (PCR) adjustment.      Secondary objectives:        -  To determine the blood concentration of the non-artemisinin component of the treatment          (lumefantrine, desethylamodiaquine or piperaquine) at day 7        -  To assess the incidence of adverse events during the follow-up period;        -  To measure speed of parasite clearance      Methods:      In vivo non comparative study as for WHO standardised protocol. The study also measure the     concentration of the non-artemisinin component.      Target population:      Children under 5 years of age consulting the integrated health centres of Andoumé and     Dix-sept portes in Maradi.      Sample size:      221 patients per study treatment; 663 patients in total.      Treatment allocation:      Random.      Outcomes:        -  Early treatment failure,        -  Late clinical failure,        -  Late parasitological failure,        -  Adequate clinical and parasitological response.      Analysis:        -  Cumulative success or failure rate (Kaplan-Meier analysis).        -  Proportions of early treatment failures, late clinical failures, late parasitological          failures, and adequate clinical and parasitological response (called also Per-protocol          analysis).   "
116917|NCT01755546|"     The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic     efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous     around-the-clock opioid analgesia for an extended period of time.   "
116918|NCT01755533|"     The goals of this study are to develop a middle school substance use prevention curriculum     for underserved rural youth and evaluate its efficacy compared to the existing, multicultural     curriculum. In addition, we are studying how the curricula get taught by the teachers.      Hypothesis 1: When compared to students in the control condition, students in the treatment     conditions will report less substance use, more conservative norms, less positive     expectations about substance use outcomes, and better life and communication skills.      Hypothesis 2: When compared to students in the control condition, students in the researcher     adaptation condition will report less substance use, more conservative norms, less positive     expectations, and better life and communication skills.      Hypothesis 3: When compared to students in the control condition, students in the teacher     adaptation condition will report less substance use, more conservative norms, less positive     expectations, and better life and communication skills.      Hypothesis 4: Researcher adaptation will have a greater impact on substance use, norms, and     expectations than teacher adaptation.   "
116919|NCT01755520|"     The primary objective of this study ist to test the hypothesis that ticagrelor is superior to     Aspirin (ASA) fort he prevention of major cardio- and cerebrovascular events (MACCE) in     patients undergoing artery bypass operation.      The primary efficiacy MACCE-endpoint is the composite of cardiovascular death, myocardial     infarction, recurent revascularisation, and stroke at twelve month after coronary artery     bypass operation.   "
116920|NCT01755507|"     Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of     Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of     PSC.   "
116921|NCT01755494|"     The primary objective of this study is to assess the pharmacokinetic parameters of     saxagliptin and metformin in healthy male Chinese subjects.   "
116922|NCT01755481|"     To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei     strain F19 or Whey Protein Concentrate.   "
116923|NCT01755468|"     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive     deterioration in the function of the pancreatic beta-cells, which are the cells that produce     and secrete insulin (the hormone primarily responsible for the handling of glucose in the     body). The investigators propose a pilot randomized controlled trial to determine whether     intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve     pancreatic beta-cell function and maintain glycemic control early in the course of type 2     diabetes.   "
116924|NCT01755455|"     This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks     increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic     anemia.   "
116925|NCT01755442|"     This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to     evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in     subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone,     metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione     (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.   "
116930|NCT01755377|"     Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic     countries because migration of people infected with T. cruzi. Current methods for diagnosis     of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce     severe side-effects, and their effectiveness cannot be properly evaluated. Reliable     biomarkers for prognosis, early diagnosis and effectiveness of treatment will be     investigated.   "
116931|NCT01755364|"     This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in young healthy     subjects. Subjects aged equal to or over 9 years old and less than 18 years old will receive     one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects aged     equal to or over 3 years old and less than 9 years old will received two doses of vaccine     (0.5 mL) by intramuscular injection into the upper arm separated by 4 weeks (28 days). Safety     outcomes included immediate reactions at the time of vaccination, solicited local and     systemic reactions within 7 days after each vaccination, unsolicited adverse events observed     since first vaccination to 28 days after the last dose of vaccination, and serious adverse     events during the observation. Sera prepared from blood samples will be collected from each     subject immediately prior to, and 4 weeks after each vaccination. Anti-hemagglutinin (HA)     antibody titers will be determined using the WHO hemagglutination inhibition reference     technique. The central laboratory who is responsible for antibody titrations will not be     aware of the background of blood samples (e.g., pre- or post-serum), it is also called     observer-blinded. All subjects will be followed, either by clinical visit or by telephone     contact, for 8 weeks after the last vaccination for safety reasons.   "
116932|NCT01755351|"     An effective treatment adherence was a key to make the treatment success, some reports had     shown that psychologicl factors impact patients adherence seriously,however, in China, the     researches were only limited to depression and diabetes,diabetes distress was neglected. Some     western studies had demonstrated the impact of diabetes distress on diabetes. Thus, we     hypothesized that: 1.perhaps our present depression-oriented health education was inadequate     to promote patients' adherence, diabetes distress might played a more important part than     depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes     distress in Chinese type 2 diabetes; so, the comparative study between diabetes distress and     depresion was conducted.      Objectives: to explore the relationship of diabetes-related distress and depression，and to     compare the influence of diabetes distress and depression on treatment adherence in Chinese     type 2 diabetes .      Research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class     hospitals using the Diabetes Distress Scale, Zung Self-rating Depression Scale, and Revised     Treatment Adherence in Diabetes Questionnaire (RADQ)simultaneously.   "
116933|NCT01755338|"     The purpose of this study is to investigate if methylprednisolone is effective in reducing     the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.   "
116934|NCT01755325|"     It is an open-label, randomized, double blind, placebo-controlled parallel-group,     multi-center study to evaluate the efficacy and safety of Compound realgar formula     Realgar-Indigo naturalis Tablet combined with Imatinib will be compared with imatinib alone     in adult patients with diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous     leukemia in the chronic phase (CML-CP).   "
116935|NCT01755312|"     This study to evaluates how a med reminder affects the patient's ability to take medications     as prescribed   "
116936|NCT01755299|"     The line of 5-hour Energy® products are available over-the-counter as energy supplements.     The appeal of these products involves ease of use, low caloric value, and the absence of     sugar to prevent a crash later in the day. The definitive efficacy and potency of the     products is unknown due to the lack of evidence-based clinical reports. It is suspected that     the efficacy related to these products is due to the caffeine content, which was reported as     138 mg per 2-ounce bottle in an online caffeine content chart. The purpose of this     randomized, double-blind, placebo controlled, four way crossover study is to evaluate the     efficacy of 5-hour Energy®, 5-Hour Energy Decaf®, caffeine, and placebo for perceived     energy and wakefulness.   "
116937|NCT01755286|"     The purpose of this study is to describe the safety and tolerability of two dose levels of     OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with     bilateral middle ear effusion who require tympanostomy tube placement.   "
116938|NCT01755273|"     Pancreaticoduodenectomy (PD) includes en bloc resection of duodenum, head of pancreas,     proximal jejunum, distal common bile duct (CBD), gallbladder, and distal stomach, which was     followed by complicated reconstructions. Therefore, PD causes change of physiological     functions, containing insufficiency of exocrine and endocrine pancreatic function,     malabsorption of nutrients, impairment of gut peristalsis, and hepatic steatosis . On the     other hand, DM may also resolve after PD in cases with pancreatic ductal adenocarcinoma. From     the study of bariatric operation, resolution of DM may occur even before body weight loss.     Postulated mechanism of resolution of DM after bariatric operation included foregut and hind     gut theory. Actually, both hindgut and foregut effects on sugar control are achieved to some     extent after pancreaticoduodenectomy. First, most of the duodenum is routinely removed in PD     and there will be no food passage through duodenum (foregut theory) after PD. Second,     proximal 10 cm of jejunum will be removed in PD and another 30~ 40 cm- long jejunum will be     brought up for pancreatic and biliary anastomosis, which will make the last enteral     anastomosis (gastrojejunostomy or duodenojejunostomy) be created at site about 50-60 cm     distal to Treitz ligament. Therefore, food will directly pass into distal jejunum (hindgut     theory). In our preliminary study, 35% patients have resolution of diabetes after PD,     especially for ones with new-onset DM. Further, a prospective randomized clinical trial will     be conducted to address if modified distal gastro-/duodeno-jejunostomy results in a higher     proportion of diabetes remission compared with standard PD.   "
116955|NCT01755052|"     SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart     attack. Patients will be interviewed in the hospital and again 6 months later. The     researchers will also collect detailed medical record information to understand the effect of     heart attacks on older persons.      The research team at Yale University will use this information to develop a risk model that     can be used to help doctors predict recovery. The goal of the study is to help older people     in the future make well-informed decisions about their health care during a heart attack.   "
116941|NCT01755234|"     80% of 25 million American who undergo surgery describe moderate to severe pain. The use of     multimodal analgesic techniques can attenuate patient's postoperative pain and several     different medication have been found to be effective. Pain can significantly affect patient's     quality of recovery after surgery. Volatile anesthetics can increase sensitivity to pain at     the low concentrations present on emergence from anesthesia. Propofol may have analgesic     effect at sedative doses. The effects of propofol,when used for anesthesia maintenance, on     postoperative pain have demonstrated controversial results with some investigators showing a     potential benefit whereas others have not shown any benefit. Propofol for maintenance of     anesthesia has been advocated as an strategy for high risk patients even though it has shown     controversial results on reduction of Post operative nausea and vomiting. A comparison of     propofol vs.volatile anesthetic in regards to the time required by patients to meet discharge     criteria has also shown conflicting results.The QOR 40 is a validated instrument that has     been specifically developed to evaluate patients recovery after anesthesia and surgery.      The purpose of this study is to compare the effects of maintenance of anesthesia with two     agents (Propofol and Sevoflurane) on quality of recovery after ambulatory surgery      Significance: the results of this study can lead to the discovery of an anesthesia technique     that is associated with a better recovery for patients after ambulatory surgery.      Research question is: do patients anesthetized with propofol have a better quality of     recovery after ambulatory anesthesia than patients anesthetized with Sevoflurane? The     hypothesis: patients anesthetized with propofol will have better quality of recovery than     patients anesthetized with Sevoflurane after ambulatory surgery.   "
116942|NCT01755221|"     The purpose of this research study is to better understand whether information obtained from     a pH probe can help physicians predict whether a patient will respond to the medication that     is prescribed for laryngopharyngeal reflux (LPR). The current treatment given to individuals     who are diagnosed with LPR is a course of proton pump inhibitor (PPI) medication. Subjects     who agree to participate in this study will have a small flexible tube (about the width of a     piece of cooked spaghetti) placed in their throat. This tube measures the pH in the throat     over a period of 24 hours and helps physicians study the relationship between pH level, LPR     symptoms, and the effectiveness of PPI therapy. This study may help physicians find out if     certain symptoms or characteristics can help them predict if the PPI medication will be     effective for each patient. After probe removal, subjects will receive compensation. They     will return to the clinic at their regularly scheduled follow-up visit with the physician, 8     to 12 weeks after starting the PPI medication. At that time, subjects can choose to     participate in an optional probe placement.   "
116943|NCT01755208|"     This pilot clinical trial studies light-scattering spectroscopy in finding disease in     patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering     spectroscopy, may help find and diagnose breast cancer   "
116944|NCT01755195|"     Background:      - Cabozantinib is a cancer treatment drug that blocks the growth of new blood vessels in     tumors. It can also block a chemical on tumor cells that allows the cells to grow. A similar     drug, pazopanib, is used to treat types of cancer known as sarcomas. Researchers want to see     if cabozantinib can be an effective treatment for types of soft tissue sarcoma that have not     responded to earlier treatments.      Objectives:      - To test the effectiveness of cabozantinib for soft tissue sarcomas that have not responded     to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have soft tissue sarcomas that have not responded     to standard treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. Imaging studies and other tests will be used to study the tumor          before the start of treatment.        -  Participants will take cabozantinib tablets daily for 28-day cycles of treatment. The          tablets should be taken whole on an empty stomach.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Participants will continue to take cabozantinib for as long as the tumor does not become          worse and the side effects are not too severe.   "
116945|NCT01755182|"     The purpose of this study is to verify if adding a locoregional treatment of liver metastasis     (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong     the progression free survival of patients affected by neuroendocrine tumors (NET) with     inoperable liver metastases   "
116946|NCT01755169|"     This study is designed to select the most tolerable dose of oral ketamine for children with     chronic pain. Children will be given either placebo or one of three dosages of oral ketamine     for 2 weeks. The dosage that is most tolerable will be selected for further study.   "
116947|NCT01755156|"     The purpose of this study is to assess the safety and efficacy of omarigliptin compared to     placebo in participants with inadequate glycemic control on metformin monotherapy. The     primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin     provides greater reduction in hemoglobin A1c (A1C) than placebo.   "
116948|NCT01755143|"     The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix     Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and     undergo an MRI scan.   "
116949|NCT01755130|"     The goal of this clinical research study is to learn if an imaging device called the Laser     Optoacoustic and Ultrasonic Imaging System Assembly (LOUISA-3D) is effective in detecting and     monitoring changes in breast tumors.   "
116950|NCT01755117|"     Total Knee Replacement can be performed under the combination of posterior lumbar plexus     block plus sciatic nerve block. The investigators can have the same outcome by performing     instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically     under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve     block.   "
116951|NCT01755104|"     The purpose of the study is to evaluate the impact of the intake of a dietary supplement     STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic     syndrome.   "
116952|NCT01755091|"     This is a proof of concept study to determine the safety and efficacy of dronabinol for the     treatment of obstructive sleep apnea syndrome (OSA).   "
116953|NCT01755078|"     The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis     patients to achieve full-scale of medical care, including reduction of atherosclerotic risk     factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.   "
116954|NCT01755065|"     The purpose of this study is to find a more accurate postoperative pain assessment for     teenager patients. This is important because a patient should not have a very strong pain     medication such as morphine if the pain is just mild.   "
117122|NCT01752881|"     The purpose of this study is to evaluate the antibody response to each of the three influenza     vaccine strains included in the licensed seasonal flu vaccine, as measured by     hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly     subjects in compliance with the requirements of the current European Union (EU)     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed     flu vaccine (CPMP/BWP/214/96).   "
116957|NCT01755026|"     Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater     (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an     antibiotic before surgery. The antibiotic is intended to prevent infection from the     surgery.It is unknown what the best dose for large women is for the usual medicine used for     this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the     skin will be biopsied at the time the incision is made and at the time the cut is stitched or     stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched     closed after the delivery. Blood tests will be done at the start and end of surgery to test     the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has     been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be     tested for the antibiotic level.These tests will be used to find out if the usual dose of     medicine is enough or if more medicine is needed to prevent infection in large women     undergoing c-sections.   "
116958|NCT01755013|"     Successful palliation of biliary obstruction is the main goal for reducing morbidity and     mortality in patients with biliary disease and biliary obstruction related to     cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a     30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time     the quality of life following surgery is only improved in a minority. At present endoscopic     insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice     without the high morbidity and mortality associated with surgery. But this relief is     unfortunately temporary since stents tend to become obstructed and the fact that effective     biliary drainage in the proximal lesion is challenging.      Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic     cells. This therapy involves the intravenous administration of a photosensitizing agent     followed by activation of the agent by illumination with non-thermal light of a specific     wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. A     randomized controlled trial study by Ortner et all confirmed the significant advantage of PDT     with regard to relief of jaundice, quality of life, and survival.      In photodynamic therapy (PDT) the uniform distribution of externally applied light is     desirable but often difficult to achieve. An optical fiber tip producing cylindrical or     lateral light emission can facilitate the application of laser energy by direct implantation     of the tip into solid tumors. However, currently used FDA approved glass diffusers used in     standard of care PDT might break in the bile ducts causing injury since they are not meant to     be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need to     evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser for     photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer plastic     optic diffuser is safe and effective in photodynamic therapy, it can be also used via a     choledochoscope. We aim to add to the clinical evidence by conducting an open label     observational study trial using this fiber optic diffuser during photo dynamic therapy in the     bile ducts.   "
116959|NCT01755000|"     The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output     Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood     cancers). Additionally, the researchers will learn if the USCOM gives additional information     about patients' conditions when their blood pressures drop and they are treated with     intravenous fluids.   "
116960|NCT01754987|"     This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment     with sorafenib versus treatment with sorafenib alone in subjects with metastatic     hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the     concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to     assess overall tumor response rate and evaluate disease progression   "
116961|NCT01754974|"     The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda     plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to     therapy with Peginterferon alfa-2a plus Ribavirin.   "
116962|NCT01754961|"     Chronic liver diseases are associated with inflammation. The investigators postulate that     Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin     D replacement in patients with Hepatitis C infection and Vitamin D deficiency.   "
116963|NCT01754948|"     Background Ambient airborne particulate material (PM) is defined according the aerodynamic     diameter into coarse, fine, and ultrafine or nano sized particles ranging between 2.5-10 µm     (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Many studies have examined particle effect on     respiratory health in children, mainly by environmental monitoring of coarse and fine     particles. Biological assessment of individual exposure to nano sized particles in     correlation to adverse health effect was not previously studied.      Hypothesis individual exposure to nano sized particles in children is associated with     reduction in forced expiratory volume at one second.   "
116964|NCT01754935|"     The current study is designed to evaluate the safety and efficacy, including MRI imaging,     across a range of VX-509 doses in subjects with active rheumatoid arthritis (RA) who have had     an inadequate response to disease-modifying antirheumatic drugs (DMARDs).   "
116965|NCT01754922|"     Following deployment to Operations Enduring and Iraqi Freedom and Operation New Dawn     (OEF/OIF/OND), Veterans report breathing problems, difficulty exercising and other symptoms.     These symptoms may be related to deployment exposures, such as regional dust and sand, smoke     from burning trash, and local industry. Studies have reported poor air quality, but very     little is known about the effect that exposure to this polluted air may have on Veterans'     short- and long-term health. Investigators will determine whether deployment-related     exposures have affected respiratory and nervous system function in these Veterans - data that     may then be used to guide rehabilitation. Ultimately, the investigators' long-term goal is to     prevent the development of chronic respiratory conditions in this group of OEF/OIF/OND     Veterans.   "
117886|NCT01742897|"     The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic     system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so     the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is     seen mostly in older persons, in which the joints become painful and stiff) participants with     moderate to severe pain.   "
116966|NCT01754909|"     This project will test the effect of enalapril to mitigate the lung damage that can occur as     a side effect of radiation therapy for lung cancer or other intrathoracic cancers. Thousands     of Veterans develop lung cancer every year, and are treated by radiation therapy. Studies of     lung radiation injury in laboratory animals show that with enalapril, investigators can     significantly reduce the severity of radiation injury to the lung. Enalapril is FDA approved     and in common use for treatment of hypertension, kidney disease, and heart failure. These     studies will advance that work to human use. Successful mitigation of lung radiation damage     will improve the quality of life in Veterans and non-Veterans who are treated for lung cancer     by radiation, and may also improve cure rates of radiation therapy for lung cancer.   "
116967|NCT01754896|"     Prior to implementation of new colorectal cancer (CRC) screening technology (fecal     immunochemical test - FIT) in Ontario, there is a need for a laboratory and field assessment     to validate and optimize its use in the Ontario climate and conditions (e.g., large     geographic area) and to determine whether adjustments to the current structure of the     ColonCancerCheck (CCC) Program would be required.      This study consists of 2 phases. Phase 1 consists of laboratory testing of FIT kits to     evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is a     field assessment to evaluate the effect of different distribution and return methods and     pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18     months to complete, with patients being recruited through family physicians in patient     enrollment model (PEM) family practices across the province of Ontario.      This Clinical Trials registration relates to Phase 2 of the study.   "
116968|NCT01754883|"     The purpose of this study is to explore the effectiveness of adding lithium carbonate     (lithium) to treatment for combat-related post traumatic stress disorder in combat veterans.     The goal of this study is to establish that lithium is a practical and tolerable treatment     option for veterans with combat posttraumatic stress disorder.   "
116969|NCT01754870|"     CLL/SLL is an incurable disease with conventional chemotherapy, and there are limited     treatment options available for patients who have become refractory to fludarabine- and     alkylating-agent based regimens. Bendamustine is a recently FDA-approved agent with     significant activity in CLL/SLL, including significant activity in the setting of     fludarabine-refractory disease. However, durations of remission following     bendamustine/rituximab combination therapy tend to be short in patients with heavily     pre-treated disease or who have already received rituximab.      The incorporation of a maintenance therapy to overcome the shorter remission durations in     this population is a reasonable and feasible option. In considering potential options for     treatment of CLL/SLL as a maintenance strategy following induction chemotherapy, lenalidomide     and rituximab are appealing options based on their convenient dosing schedules and recent     evidence of acceptable toxicity and promising efficacy in combination therapy.   "
116970|NCT01754857|"     The investigators propose a treatment strategy where patients are treated with induction     chemoimmunotherapy consisting of rituximab + bendamustine for 6 cycles, followed by     initiation of maintenance rituximab and lenalidomide among patients achieving an objective     response (i.e., at least stable disease with some tumor shrinkage) to induction therapy. The     goal of maintenance therapy will be to capitalize on the cytoreduction following induction     chemotherapy with a maintenance regimen that has also shown promising activity in CLL, in     order to allow for improved PFS in this population.   "
116971|NCT01754844|"     This is a First in Human study to assess the safety and tolerability of AZD7624, following     inhaled administration of single ascending doses in healthy male volunteers and female     volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug)     and pharmacodynamic (what the drug does to the body) parameters will be also assessed as     secondary objectives.   "
116972|NCT01754831|"     The specific aim of the study is to determine the excess urinary fluoride and its time course     after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15     month old infants. From these data the investigators can estimate the bioavailable (more     precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration     that will allow an estimate of the margin of safety of the procedure.   "
116973|NCT01754818|"     The purpose of this study is to assess the study medication blood levels after administration     of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on     the volunteers will also be assessed.   "
116974|NCT01754805|"     A drug interaction study to evaluate the effect of ASP015K (twice daily) on the     pharmacokinetics (PK) of once weekly oral methotrexate (MTX).   "
116975|NCT01754792|"     The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism     parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic,     impaired and normal fasting glucose subjects.      This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design.     Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or     normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.   "
116976|NCT01754779|"     The investigators will examine in two studies whether citric acid or potassium citrate can     reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.   "
116977|NCT01754766|"     This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic     conjunctivitis.   "
117002|NCT01754441|"     Spinal muscular atrophy is a genetically based disease that affects motor neurons in the     spinal cord and leads to muscle wasting and weakness. The gene found to be responsible for     the underlying disease is called the SMN or survival motor neuron gene. Individuals with SMA     are either missing a copy of the gene or have a mutation in the gene. Although the gene has     been identified, how it actually causes the motor neurons to die and leads to muscle wasting     and weakness is not completely understood. The investigators have found that skin cells from     children with SMA tend to be more susceptible to cell death when exposed to cell death     inducing agents. In this protocol, The investigators wish to study the mechanisms by which     these cells die when exposed to these agents and how this may be related to the gene defect     and the disease.   "
117003|NCT01754428|"     The purpose of this study is to collect clinical outcome and nasal viral load information.   "
117004|NCT01754415|"     The aim of this study is to evaluate the effect of hydraulic resistance circuit training for     elderly people with chronic illness.   "
117060|NCT01753687|"     Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory     response of the ocular surface. Common symptoms include ocular discomfort, visual impairment     and instability of the tear film with potential damage to the ocular surface.      The rationale of the present study is to compare signs as assessed with new methods such as     measurement of tear film thickness, tear film osmolarity and scattering of the tear film with     well established methods for assessment of the severity of DES (Break up time, staining of     the cornea with fluorescein). Additionally, impression cytology and determination of tear     cytokines/chemokines will be performed to obtain information about inflammatory processes on     the ocular surface.   "
116978|NCT01754753|"     The National Institute for Health Research commissioned this research with the following     research question: What is the relative effectiveness and cost effectiveness of home based     support programmes in improving the mental wellbeing of older people living in their own     homes?      The project will evaluate whether telephone friendship groups, delivered by the voluntary     sector over the telephone, can improve the mental wellbeing of older people aged 75 or over.      The research will also:        1. Identify the psychosocial and environmental factors, as well as implementation issues          that may mediate or modify the effectiveness of the intervention using qualitative          methods. This will include examining: 1.1. Assess voluntary sector readiness to take          forward new forms of services; 1.2. The best modes of delivery of telephone          support/friendship; 1.3. Assess how volunteers (facilitators) can be supported and          retained; and, 1.4. The extent to which fidelity of the intervention is maintained          within and across the participating organisations.        2. Determine if there is any lasting impact upon mental wellbeing by repeat measurement          with all participants 12 months following baseline measurement        3. Examine whether there is any significant improvement on the physical dimension of the          SF-36 at 6 months and 12 months, following baseline measure, for the intervention arm          compared with usual care.        4. Measure the extent of use of health and social care, and community facilities by          participants over time to determine whether the intervention is cost effective compared          with usual care.   "
116979|NCT01754740|"     Objectives: to evaluate xerostomia and salivary flow in patients with burning mouth syndrome     (BMS) treated with amitriptyline before and after the use of antixerostomic topical     medication.      Methods: In this case-control double-blinded study, we enrolled 38 patients with BMS     diagnosed according to the (IASP). The subjects were randomly divided into two groups: Study     Group: 19 patients whom received topical medication of urea 10% and Control Group: 19     patients whom received placebo to apply at the oral cavity 3-4 times per day, during three     months. The patients were evaluated before and after the above treatment. Finally, data were     statistically analyzed.      It is know that BMS is eventually associated to reduced salivary flow (Cho et al.,2010; Kho     et al., 2010; Marino et al., 2010) and to abnormal salivary composition (increasing     concentrations of K+, Na+, Cl-, Ca+2, IgA, amylase) (Patton et al., 2007). Even in the     absence of hyposalivation, patients may complain of xerostomia and dry mouth (Cho et     al.,2010; Kho et al., 2010; Marino et al., 2010; Thomson, 2005). These patients also have     several sensory losses even in taste and smell function, recently described (Siqueira et al.,     2006a; Siqueira et al., 2006b; Siviero et al., 2011).   "
116980|NCT01754727|"     The purpose of this study was to assess the proportion of AS patients achieving treatment     response to adalimumab therapy.   "
116981|NCT01754714|"     Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty     Liver Disease and non-treated matched healthy volunteers as control group   "
116982|NCT01754701|"     The purpose of this study is to determine whether iron therapy given to iron-deficient     Ugandan children with moderate-to-severe anemia and clinical malaria is better absorbed and     incorporated into red blood cells if it is given concurrently with antimalarial treatment on     Day 0 (immediate group) or 4 weeks after antimalarial treatment on Day 28 (delayed group).     Use of iron stable isotopes 57Fe and 58Fe will permit measurement of red blood cell iron     incorporation on Day 0 and Day 28 in all children. The investigators hypothesize that red     cell iron incorporation at the time of initial supplement administration will be greater in     children receiving delayed vs. immediate iron (Aim 1), and children in the delayed group will     also have greater hematological recovery on Day 56 than children in the immediate group (Aim     2).   "
116983|NCT01754688|"     The investigators hypothesize that a new BIND (Bilirubin Induced Neurologic Dysfunction)     scoring method adapted for the developing world (BIND II, developed by our team for use by     health care workers), with additional modifications for community use (the community BIND,     C-BIND), will improve the ability to identify infants with ABE and to distinguish ABE from     other common causes of neonatal morbidity and mortality compared to currently available     survey tools.   "
116984|NCT01754675|"     Watching football matches could cause increased blood pressure and heart rate induced by     catecholamines and thus increase the incidence of cardiovascular events. However, no studies     have evaluated the responses of blood pressure and heart rate in soccer spectators.      This study evaluates the hemodynamic response in Brazilian soccer fans suffering from     coronary artery disease during a dispute over a game of your favorite team.   "
116985|NCT01754662|"     Diabetes is an increasingly common condition affecting millions of people world wide. The     cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is     known that food containing compounds called polyphenols can reduce the risk of heart disease     risk in people with diabetes. Two foods that are rich sources of polyphenols are cocoa     (epicatechins) and soy (isoflavones). Previous studies have shown the benefits of these foods     in the diets of people with diabetes. It has also been shown that soy isoflavones and cocoa     polyphenols can improve the mood in certain groups of patients.      What is not known is whether there is any extra benefit of combining soy protein and     isoflavones with cocoa.      The aim of the study is to look at the modification of cardiovascular risk by soy and/or     cocoa in patients with type 2 diabetes, alone or in combination.   "
116986|NCT01754649|"     To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled     randomized clinical trial)to facilitate the insertion of copper-IUD and the     levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical     stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects     of the misoprostol. The hypothesis is that misoprostol may be better than placebo.   "
117005|NCT01754402|"     This study is designed as a phase I-II, open label, dose finding study.      Study treatment will be as follows, in 28 day cycles:        -  Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days        -  Bendamustine: once intravenously (IV) dosing on day 1, every 28 days        -  Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22.      After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per     investigator discretion. After completing 12 cycles of treatment, patients will proceed to     the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28     days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.   "
116987|NCT01754636|"     Background: Inadequate representation of elderly cancer patients in randomized clinical     trials (RCTs) leading to a lack of external validity thereby an uncertainty regarding     benefit-risk balance of cancer treatment in elderly, especially chemotherapy.      Hypothesis: The eligibility criteria explain only a part of the under-representation of     elderly patients in trials. We make the assumptions that 1) Among the eligible, the     invitation to participate in a trial and inclusion are inversely related to age, 2) Among the     eligible, there are patients, practitioner, or organization factors that would explain the     non inclusion of elderly patients.      Objectives:      1) To assess, in elderly patients with colorectal cancer, the proportions of patients:        1. eligible at least to one RCT        2. invited to participate        3. included 2)      a) Compare proportions among elderly patients to those of the comparator group of young     subjects (age ≥ 18 and <65 years) (added by amendment n°3 accepted 18/02/2014) b)To identify     factors associated with the non-invitation and the non-inclusion in RCT.      Material and methods:      Study design: A multicentric prospective cohort survey Population: all patients aged 18 years     or more (added by amendment n°3 - 02/2014) with a colorectal cancer followed in one of the     participating centers.      Data collection:        -  At baseline: Patient characteristics (including SOCIO-demographic, oncologic and          geriatric data) will be collected. Organization factors (e.g. clinical research team)          will be collected.        -  Follow-up: the patient will be followed for potential invitation and inclusion in one          RCT. Reasons of non-invitation or non-inclusion will be assessed.      Number of subjects needed: 696 (553 elderly patients and 143 young patients) Number of     centers : 7 (added by amendment n°3 - 02/2014)      Ethical aspects: each patient will give his oral informed consent. The International Review     Board of Mondor Hospital (CPP Ile-de-France IX) gave its approval in December 2012.   "
116988|NCT01754623|"     The purpose of this study is to find out if a program of intensive chemotherapy with     gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation     aimed at participant's tumor followed by more chemotherapy can increase the chances that the     participant's pancreatic tumor can be removed completely.   "
116989|NCT01754610|"     Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the     National Institute on Drug Abuse's intervention development model by testing a new family,     skills-based intervention involving pre-post evaluation of families participating in     multi-family groups. The purpose of this study is to gather practice-based evidence on the     effectiveness of the manualized treatment, on the dynamics involved in the group format, and     on implementation fidelity and feasibility. Analyses will involve initial exploration of the     following hypotheses: 1) Families will show a significant increase in the constructive use of     family coping skills and in general family functioning. 2) The target child will show a     reduction in trauma-related symptoms and behavior problems. 3) Families will engage and     participate in the treatment. 4) Providers will implement SFCR with fidelity.      Other outcomes of interest are the process measures that will be collected to monitor     participation in the groups, cultural sensitivity and acceptability, clinician competence,     and intervention integrity.   "
116990|NCT01754597|"     The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical     and echocardiographic monitoring. In the case of treatment for breast cancer, surgery     requiring general anesthesia may follow chemotherapy. Although a possible interaction between     general anesthetics and anthracyclines on systolic function is only rarely mentioned, some     cases of heart failure and / or conduction disturbances peranesthésique were observed in     patients treated or previously treated with anthracyclines. The determination of     concentration of BNP is a diagnostic tool used in the detection of heart failure and acute     coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines     and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value,     the BNP assay might thus allow to highlight a possible subclinical deficiency. To our     knowledge, there is very little data regarding a possible synergism between cardiotoxic     anthracyclines and anesthetic agents.   "
116991|NCT01754584|"     The mucociliary system of nasal mucosa, which is composed of the ciliated respiratory     epithelium, the mucous blanket, and the mucus-producing glands, is an important defense     component of the respiratory system. Therefore, it is important to maintain intact inner     respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the     development of tissue engineering trachea. Hyaluronan derivatives, which are biodegradable     and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes.     However, the feasibility of use as a scaffold for respiratory epithelial cells remained     unexplored. The aim of the study is to investigate the effect of hyaluronan including     concentrations and molecular weight on the mucociliary differentiation of human respiratory     epithelial cells (HREC). If hyaluronan is able to promote mucociliary differentiation of     HREC, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials     for respiratory tissue engineering and tissue-engineered trachea in the future.   "
116992|NCT01754571|"     According to the definition from International Headache Society, medication overuse headache     (MOH) is diagnosed when patients takes painkillers for more than 10 or 15 days per month     (depending on what kind of painkillers being used), for more than 3 months, which results in     the deterioration of headache. The treatments of MOH include preventive medication of     headache and withdrawal of the overused painkillers. Other than the simple oral advice, some     researchers recommended non-pharmacological methods. Pryse-Phillips et al. (1998) reviewed     the the treatment of migraine and suggested that biofeedback, relaxation, cognitive behavior     therapy (CBT), psychological therapy, hypnosis and physical treatment are effective.     Researches also point out CBT is effective on withdrawing medication in patients with MOH     (Kroner-Herwig, 2009). Lake (2006) reported that behavioural therapy maybe an adjunct therapy     to preventive medication to reduce the relapse rate of medication overuse.      The purpose of this study is to confirm the effect of CBT in patients with MOH. The target is     to reduce the frequency of headache and use of painkillers. Patients could benefit from the     education and relaxation training during CBT to cope with headache and reduce the use of     painkillers.      The research will recruit 60 patients with MOH at Neurology Clinics, Far Eastern Memorial     Hospital. They will be separated into two groups, 30 in control group and the other 30 in the     experimental group. Education of MOH, relaxation and cognitive restructuring would be     included in the four weeks training program. The training program is under the supervision of     a neurologist from Far Eastern Memorial Hospital and a psychology professor from Fu Jen     Catholic University. The control group will accept four weeks telephone interview to confirm     their headache diary including the frequency of headache and use of painkillers. The     frequency of headache and medication use will be used for analyzing the effect of CBT.   "
117025|NCT01754142|"     The purpose of this post-marketing surveillance is to investigate and confirm the type and     incidence of newly identified adverse events and any other factors affecting safety and     efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the     marketing approval properly   "
117044|NCT01753895|"     Blood pressure (BP) measurement is one of the most commonly performed screening tests in the     clinical setting. Its accuracy is vital to the early diagnosis and effective management of     hypertension, as emphasized by hypertension management guidelines. For most protocols being     conducted in a clinical research setting, obtaining single or serial blood pressure     reading(s) is often performed as a safety assessment, especially if the individual is     participating in a study that requires a blood draw and/or the administration of a research     drug, vaccine or device. It is imperative that the blood pressure data truly reflect the     response, if any, the study participant experiences in relation to the research procedures     and interventions.   "
116993|NCT01754558|"     During the last decade numerous new procedures have been presented regarding surgical     treatment of urinary stress incontinence (1,2). Development of the midurethral tape procedure     (TVT) changed the surgical procedure dramatically both regarding the extent of the surgical     procedure and also decreased the morbidity remarkably. The success rate of the TVT procedure     has been proven to be high (1,2 ). However, the development of the TOT/TVT-O procedures     disclosed a new fixation point and further decreased the risk of bladder injury (1,2). Since     the introduction of trans-obturator slings several mini-slings have been introduced in order     to reduce the need of perforation of the skin and muscles (3,4,5). Although some systems seem     promising (5) others have disclosed a long learning curve, pain problems following the     procedure and lower success rates, compared to the traditional sling procedures. None of     these mini-slings have been adjustable.      Recently the Ajust system for treatment of stress urinary incontinence was introduced. The     system is a single incision sling procedure and consists of an adjustable Polypropylene mesh     sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective cure     rate was 82%, but there is a lack of information regarding adverse events and durability of     treatment success. Our preliminary experiences suggest, that the procedure has a rapid     learning curve, low pain scores postoperatively and a 94% cure rate at 3 months follow-up     (personal observation). Recently, several abstracts have indicated that the cure rate     obtained by Ajust is comparable to TVT or TVT-O (10-12).      The purpose of the present study is (primary outcome):      To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal     regarding subjective cure rate (cure is defined as subjectively not incontinent at all), i.e.     the study is designed as a non-inferiority study. The study is performed as a randomised     controlled trial without blinding. The study is powered to detect a 9% difference between the     two groups. The subjective cure rate is based on ICIQ measurement      Secondary outcome:        -  To test the hypothesis that Ajust is associated with a significantly lower postoperative          pain perception.        -  To test the hypothesis that antibiotic treatment is not necessary   "
116994|NCT01754545|"     Congenital thrombotic thrombocytopenic purpura (TTP), also called Upshaw-Schulman Syndrome or     hereditary or familial TTP is a rare, but severe disease. The purpose of this study is to     determine how infusions of plasma to patients with congenital TTP correlate with symptoms and     signs of activity of the disease, and to determine why some patients need more frequent     infusions of plasma than others to prevent acute attacks of the disease.   "
116995|NCT01754532|"     The importance of stress as a possible deteriorating factor for schizophrenic patients is     well documented. However, this notion is based on subjective experience and retrospective     psychological analysis.      A novel method of measuring cortisol using hair has a proven correlation to subjective stress     in non-clinical as well as psychiatric clinical populations.      This pilot study will attempt to assess the use of cortisol hair level, as a marker of     stress, to predict clinical deterioration in schizophrenic patients.   "
116996|NCT01754519|"     This phase II trial studies how well radiation therapy works in treating post-menopausal     women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x     rays to kill tumor cells. This may be an effective treatment for breast cancer.   "
116997|NCT01754506|"     The purpose of this study is to test the efficacy of an oral, nutrient intervention     containing the bioactive components of fish oil to promote healing of chronic venous leg     ulcers (CVLU). If this systemic, nutrient intervention is found to alter the microenvironment     of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved.   "
116998|NCT01754493|"     This study will evaluate the efficacy of duloxetine in reducing depressive symptoms,     abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of     outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.   "
116999|NCT01754480|"     This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in     patients undergoing open surgical procedures where bleeding may be present on parenchymous     tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to     demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized     cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage     of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with     the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to     assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study,     patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.   "
117000|NCT01754467|"     Sedentary behavior is associated with an increased risk of mortality and many health     conditions including type 2 diabetes, obesity, cardiovascular disease, and metabolic     syndrome, independent of the time spent in moderate-to-vigorous intensity physical activity     (MVPA). Furthermore, independent of total sedentary time and MVPA, Healy et al. observed that     individuals who had more breaks in sedentary time had lower 2-h plasma glucose. Recent     experimental findings also suggests that breaking up prolonged bouts of sedentary behavior (≥     20 minutes) with either light or moderate intensity activity for 2 minutes reduces     postprandial glucose and insulin responses.10 Replacing sedentary time with light-intensity     activity or nonexercise activity thermogenesis (NEAT) may help to reduce the health     consequences of sedentary behavior. The purpose of this study is to develop a smartphone     application (NEAT!) to encourage sedentary adults with diabetes to increase breaks in     prolonged bouts of sedentary behavior objectively measured by an accelerometer. NEAT! will be     refined by modifying technology created for the ENGAGED trial (RC1DK087126) and will work in     conjunction with a Bluetooth enabled accelerometer that can detect bouts of sedentary     behavior. When a sedentary bout (≥ 20 minutes) is detected, the smartphone application will     trigger a reminder prompt to the user encouraging him/her to participate in NEAT for at least     2 minutes. Following the development, testing, and refining of the application, a sample of     10 sedentary adults with type 2 diabetes will be recruited to participate in a one month     trial to examine the feasibility and acceptability of NEAT!. To our knowledge, this is the     first study to design and examine the acceptability of a smartphone application that will     target interrupting sedentary behavior with NEAT using objectively measured sedentary time in     a diabetic population.   "
117001|NCT01754454|"     Allogenic haemopoietic stem cell transplantation (allo-HSCT) is the treatment for many     malignant and non-malignant hematologic disorders. Acute graft-versus-host disease (aGVHD) is     a serious life-threatening complication after allo-HSCT. The outcome for patients with aGVHD     is poor and overall survival is low. Acute graft-versus-host disease (GVHD), as the major     complication of allogeneic peripheral blood stem cell transplantation(PBSCT), limits the     application of this curative therapy. Mesenchymal stem cells (MSCs) are multipotent stem     cells, which are able to modulate immune response in vitro and in vivo, and have     possibilities of treating diseases caused by immune dysregulation such as aGVHD. MSCs     obtained from umbilical cord (UC) have similar immunosuppressive properties as bone     marrow-MSCs. In addition, UC-derived MSCs can be used for off-the-shelf use and are obtained     without any harm to donors than bone marrow-MSCs. Therefore, the investigators designed this     study to evaluate the safety and efficacy of UC-derived MSCs in patients with aGVHD.   "
117058|NCT01753713|"     This phase II trial studies how well dovitinib works in treating patients with recurrent or     progressive glioblastoma. Dovitinib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth   "
117059|NCT01753700|"     The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk     on bloodlipid profile   "
117887|NCT01742884|"     The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed     to controlled adverse environmental conditions.   "
117006|NCT01754389|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug to learn whether the drug works in treating a     specific cancer. Investigational means that the drug is still being studied and that     research doctors are trying to find out more about it-such as the safest dose to use, the     side effects it may cause, and if the drug is effective for treating different types of     cancer. It also means that the FDA has not yet approved bortezomib to treat or prevent     graft-versus-host disease. Bortezomib is approved by the FDA to treat other human     malignancies.      Bortezomib is a drug that has an anti-cancer effect that involves inhibiting cell growth and     causing cell death. This drug has been used in other research studies, and information from     thos other research studies suggests that bortezomib may help to lower the risk of GVHD after     allogeneic stem cell transplantation in patients who have matched unrelated, unmatched     related or unrelated donors in this research study.      Allogeneic stem cell transplantation is a procedure in which selected blood cells taken from     your sibling or unrelated donor are given to you. Lower doses of chemotherapy drugs are given     before the donor cells are infused in a process known as reduced-intensity conditioning. Stem     cell transplant destroys cancer in two ways: The conditioning regimen destroys cancer cells     and teh immune cells from the donor can recognize cancer cells and kill them.      A common problem after stem cell transplant is graft-versus-host disease (GVHD). The word     graft refers to the donor blood cells that you will receive during your transplant. The     word host refers to the person (in this case, you) receiving the cells. GVHD is a     complication of transplantation where the donor graft attacks and damages some of your     tissues. GVHD can cause skin rash, intestinal problems such as nausea, vomiting or diarrhea.     GVHD may also damage your liver and cause hepatitis or jaundice. GVHD may also increase your     risk of infection.      After stem cell transplant, all patients receive prophylactic medications against GVHD. In     this research study we are studying the safety and effectiveness of preventing GVHD using     bortezomib treatment in combination with other drugs versus standard of care prophylaxis     (tacrolimus + methotrexate). If you take part in this study, there is a 33% chance you will     receive any one of the following GVHD prevention treatments:        -  tacrolimus + methotrexate (standard of care GVHD prophylaxis)        -  bortezomib + tacrolimus + methotrexate        -  bortezomib + sirolimus + tacrolimus Sirolimus, tacrolimus and methotrexate are drugs          that suppress the immune system to try to prevent GVHD.   "
117007|NCT01754376|"     This research study is a Phase II clinical trial of an investigational combination of drugs     (vemurafenib and aldesleukin) to learn whether the combination works in treating a specific     cancer. While both vemurafenib and aldesleukin are approved by the FDA for the treatment of     metastatic melanoma, the FDA has not yet approved the combination of vemurafenib and     aldesleukin.      Researchers have found that a large number of melanoma cells have mutations in the BRAF gene.     It has been shown that vemurafenib blocks the effects of these mutations in the BRAF gene,     and, as a result, may help to prevent cancer growth.      Aldesleukin, also referred to as IL-2, is an immunotherapy drug administered via IV infusion     that increases the growth of key cells within the immune system that are responsible for     targeting cancer cells. Activating more of these key cells, called T-lymphocytes and     natural-killer cells, leads to increased cancer cell death.      The BRAF gene is located on a larger pathway called the MAPK pathway. Studies have shown that     when a BRAF inhibitor, like vemurafenib is used to block the MAPK pathway, melanocytes, or     cancer cells express more proteins on their surfaces, making them easier for T-lymphocytes     and natural killer cells to recognize and kill them. This suggests that combining     BRAF-targeted therapy with aldesleukin, which activates more of these white blood cells, can     lead to an increase in the death of cancer cells.      In this research study, the investigators are looking to see whether the combination of     vemurafenib (a BRAF-inhibitor) combined with aldesleukin(an immunotherapy drug) work together     to produce a better health outcome in people with metastatic melanoma.   "
117008|NCT01754363|"     This post-marketing investigation will evaluate the long term (up to 15 years) survivorship     of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint     disease. Data from Subjects who receive one of four knee configurations will be pooled to     establish a contemporary dataset.   "
117009|NCT01754350|"     Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is     important for the generation of ATP, supply of anabolic substrates and defense against     reactive oxygen species in tumor cells. In preclinical models, restricting glucose     availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor     growth.      Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic     diet and transient fasting can enhance the efficacy of reirradiation in patients with     recurrent glioblastoma.   "
117010|NCT01754337|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would     regulate glucose levels through the infusion of two hormone: insulin and glucagon.      The main objective of this project is to compare the efficacy of single-hormone closed-loop     strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a     24-hours in-patient study with standardized conditions in adults and adolescents with type 1     diabetes.      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in     regulating glucose levels in adults and adolescents with type 1 diabetes compared to     single-hormone closed-loop strategy, which in turn is more effective than the conventional     pump therapy.   "
117011|NCT01754324|"     The chronic use of opiate medications during pregnancy is a major public health challenge.     Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly     referred to as neonatal abstinence syndrome (NAS). Signs of NAS may include irritability,     high-pitched crying, muscle tightness, seizures, diarrhea, vomiting, poor feeding, and     unstable body temperature. Many infants may be treated by supportive (non-pharmacological)     therapy by minimizing stimulation, cuddling, responding promptly to hunger cues, and other     comfort care. However, some infants continue to show severe symptoms of withdrawal despite     these interventions. In these cases, infants may be treated with medications (pharmacological     therapy). Although it has been several decades since the first descriptions of NAS, there     still remains limited information with regards to the most effective treatment. We     hypothesize that medical treatment protocols of NAS with methadone can be optimized by better     understanding what the body does to the drug (the population-based pharmacokinetics of     methadone).   "
117042|NCT01753921|"     This is a research study to understand how diabetic ketoacidosis may affect the brain and     learning and to see if these changes are transient or permanent. The investigators hope to     learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing     a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™     (NNS), learning, talking, behavior, or development. The investigators will compare those     results from those with diabetes mellitus to those age and gendered matched healthy controls.     Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less     than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17     years old.   "
118992|NCT01728415|"     The purpose of this study is to evaluate the effects of high intensity interval training     compared to moderate exercise training and a control group on exercise capacity and quality     of life in patients with end stage renal disease on hemodialysis.   "
117012|NCT01754311|"     Only 5 to 10% of patients infected with HTLV-1 develop a disease related to infection. The     two most serious diseases are adult T-cell leukemia (ATL) and Tropical spastic paraparesis     /HTLV-I-associated myelopathy (TSP / HAM). Factors influencing the development of TSP / HAM     in the individual HTLV-1 are not yet completely understood. Patients TSP / HAM have a HTLV-1     proviral load (amount of virus) that is 6-10 times higher than seropositive asymptomatic.      Various studies have shown that the development of TSP / HAM in the subject HTLV-1 and its     rapid evolution is partly attributed to the failure of the immune system that regulates viral     replication and expression.      It has recently been shown that different versions of Single Nucleotide (human leukocyte     antigen) rs12979860, located upstream of the gene for Interleukin 28B (IL28B), influenced the     severity of infection with hepatitis C and effectiveness of treatment.      By analogy with hepatitis C, a Spanish (Treviño et al., 2012) examined this SNP(single     nucleotide polymorphism) in 12 patients TSP / HAM and 29 asymptomatic HIV-positive. CT or TT     genotype was statistically more frequent in the group TSP / HAM than in asymptomatic patients     (80% versus 20%) and was associated with HTLV-1 proviral load higher.      We propose a broader group of patients in our population and Afro-Caribbean, to confirm the     results of the latter study was conducted in a predominantly Latin American population.   "
117013|NCT01754298|"     The purpose of this study is to compare the functional, clinical and radiographic outcomes     associated with trans-articular drilling versus retro-articular drilling, two commonly     employed techniques of operative treatment for stable forms of juvenile osteochondritis     dissecans (JOCD) lesions. This study also aims to better define the natural history of this     condition in its most commonly identified pathological state (as a stable lesion) following     surgical intervention by determining the rate of radiographic healing and any need for     secondary surgery.   "
117014|NCT01754285|"     This is a phase II, multicenter, double-blind, double-dummy, parallel-group,     placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest     cancer who are undergoing breast surgery with axillary lymphnode dissection.      Recruited patients will be randomly assigned to one of the following treatment groups:     Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.      Mode of administration is single intramuscular (IM) injection so the treatments arms are as     follows:      Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2     injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg      The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.   "
117015|NCT01754272|"     This is a follow-on study to the VELOUR trial (NCT00561470). The aim of this study is to     acquire the archived colorectal cancer and metastasized tissue tumour blocks of patients who     have participated in the VELOUR study.      These samples will be analysed to find proteins or markers which represent how an individual     may be responding to treatment. The identification of these markers may help provide     personalised and more effective treatment programs for patients with similar conditions in     the future.   "
117016|NCT01754259|"     Coronary vascular dysfunction is highly prevalent among patients with known or suspected     Coronary Artery Disease (CAD)1, increases the severity of inducible myocardial ischemia     (beyond the effects of upstream coronary obstruction)2, and identifies patients at high risk     for serious adverse events, including cardiac death1, 3-5. Diabetic patients without known     CAD with impaired coronary vascular function show a risk of cardiac death comparable to, and     possibly higher, than that for non-diabetic patients with known CAD10. In the setting of     increased oxygen demand, coronary vasodilator dysfunction can upset the supply-demand     relationship and lead to myocardial ischemia, subclinical left ventricular dysfunction     (diastolic and systolic), and symptoms.      The significance of microvascular coronary dysfunction is increasingly recognized as invasive     and non-invasive (PET) methods of quantifying CFR become available.      Importantly, current treatment strategies for obstructive CAD, such as percutaneous coronary     intervention with angioplasty and stenting, are not helpful in microvascular disease.     Similarly, mortality-altering treatments for systolic heart failure, such as angiotensin     converting enzyme inhibitors, have not been beneficial in treating diastolic dysfunction.   "
117017|NCT01754246|"     The purpose of this study is to assess treatment for facial skin toning and removal of     epidermal pigmented lesions for Asian patients using the 755nm Alexandrite laser   "
117018|NCT01754233|"     The purpose of this study is to assess treatment for facial dermal and epidermal pigmented     lesions using the 755nm Alexandrite laser.   "
117019|NCT01754220|"     Montelukast, a leukotriene receptor antagonist, is likely to be effective in the treatment of     chronic cough and this could be made objective by measuring cough threshold before and after     two weeks of treatment.   "
117020|NCT01754207|"     The purpose of this study is to collect further data on the safety and efficacy of removing     unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.   "
117021|NCT01754194|"     Study objectives:        1. generate local clinical, health-related quality-of-life and health economic data to          evaluate the benefits of two types of minimally invasive weight-loss surgery        2. support multi-disciplinary bariatric sites in Germany by providing structured procedure          guidelines and training, therefore facilitating procedural adoption, increasing safety          and shortening the learning curve for weight-loss surgery.   "
117022|NCT01754181|"     The main objective is to assess if the Diabeloop algorithm provides better glycemic control     than a manual usual algorithm of patients with type 1 diabetes treated by insulin pump     during meals, and during activity qualified moderate to severe by the patients.      The study will be conducted in 18 patients. The investigation centers are: CHSF (for     Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop     algorithm test during meals.   "
117023|NCT01754168|"     The investigators propose to study persons with Parkinson Disease (PD) with detailed     clinical, cognitive and imaging at the time of study entry and repeat these assessments 2     years later. The study looks at how changes in activity of the neurotransmitter acetylcholine     relates to changes in cognitive function and to see if there is presence or build up of     amyloid protein.   "
117024|NCT01754155|"     The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome     measures to evaluate early, post-operative implant stability, post-operative implant     fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E     stabilized polyethylene.   "
117026|NCT01754129|"     In patients with advanced levodopa-responsive Parkinson's Disease and severe motor     fluctuations despite optimized treatment with conventional oral Parkinson's Disease     medications, treatment with Duodopa represents an alternative treatment option to improve     motor, non-motor performance and overall quality of life. These benefits have been obtained     in short and mid-term trials (mainly up to 2 years). Data on long-term effectiveness (5 years     of treatment or more) and safety are not available. Also data concerning the benefit of     Duodopa on cognitive function, axial symptoms and disability have to be confirmed. Recent     data on deep brain stimulation (DBS), the alternative option treatment in advanced     Parkinson's Disease patients, showed that after 5 years from the implant, a worsening of     axial symptoms (gait and balance) and after 1 to 3 years of speech could occur. Moreover, it     has never been assessed if the benefit on motor and non-motor symptoms in patients treated     with DUODOPA could be influenced by age and duration of the disease, as already shown for DBS     implanted patients. This study should clarify the missing information on long-term benefit of     Duodopa (up to 7 years) especially focusing on motor fluctuations and disability.   "
117027|NCT01754116|"     This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult     subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg     intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This     study will evaluate LAP formulations of GSK1265744 with different particle sizes.      Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400     mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by     intramuscular injection. Samples for determination of GSK1265744 concentrations will be     collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording     and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects     will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last     day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A     enzymes.      The subjects will undergo follow-up evaluations for a minimum of 12 weeks.   "
117028|NCT01754103|"     Brain plasticity of cortical activity caused by repetitive tactile stimulation could have a     progressive development that was from primary parietal areas, passing over parieto-occipital     areas and came secondary to primary occipital areas. This process allows to understand the     existence of neurons in the brain and specific areas for certain functions independent of the     type of stimulation is performed.      By performing repetitive tactile stimulation over a period of 3 months,using a tactile     stimulator, our group will try to prove several that repetitive tactile stimulation can     create cross-modality and improve recognition and localization of patterns in blind people.   "
117029|NCT01754090|"     The purpose of this study is to test whether an online multi session alcohol intervention     improves treatment effect compared to single session screening with feedback only.      All participants in the trial received a single session screening procedure including     individualized normative feedback (usual care). Additionally, half of the participants     received a simple online booklet about the effects of alcohol. The other half received an     online multi session follow up program.   "
117030|NCT01754077|"     The purpose of the proposed research is to evaluate the Thirty Million Words (TMW)     Intervention through a randomized, controlled pilot study. The primary goal of the     intervention is to enrich the early language learning environment of children from     low-socioeconomic status (SES) backgrounds by targeting parent skills that relate to adult     word input and conversational turn taking. The investigators hypothesize that receiving the     TMW intervention will result in changes in parent behaviors.   "
117031|NCT01754064|"     SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of     patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM)     products. This registry will be conducted in the United States (US).      The primary purpose of the registry is to evaluate and publish acute and long-term     performance of market-released SJM CRM products by analyzing product survival probabilities.     Product status and any related adverse events will be collected to measure survival     probabilities.   "
117032|NCT01754051|"     This study is a prospective, multi-center registry of patients with intracranial aneurysms     who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months     post-procedure for the study.   "
117033|NCT01754038|"     This registry will perform prospective surveillance of participants attending collaborating     Integrative Medicine clinic sites for clinical services. All decisions about medication use,     treatments, visit frequency, assessment of tolerance, and other aspects of patient management     will be left to the clinical providers' discretion. We will attempt to follow the     participants in the PRIMIER Registry for up to 2 years.      Essential data elements that capture patient-reported outcomes and measures of clinical     activity will be obtained at approximately 2-month intervals for the first 6 months, then     every 6 months through the end of year 2.   "
117034|NCT01754025|"     Lung cancer is a common malignancy that is associated with cigarette smoking but can also     affect individuals who never smoked. It is not well understood whether there are hereditary     risk factors that influence the risk of lung cancer.      It has been recently found that a small number of families have an inherited (passed from     parent to child) change in one of their genes that may contribute to an increased tendency to     develop lung cancers, even in never smokers. In some lung cancer patients this gene, called     EGFR, contains a DNA change known as an inherited EGFR mutation. Early data indicate that     these inherited EGFR mutations may be associated with an increased risk of lung cancer.      So far, only a small number of families have been found to carry inherited EGFR mutations.     For this reason the risk of lung cancer associated with inherited EGFR mutations is not well     understood. Understanding the risk may help investigators find ways of detecting lung cancer     sooner or reducing the risk of developing lung cancer.      It was recently discovered that lung cancer patients who are found to carry one rare EGFR     mutation in their cancer cells, called T790M, have an increased risk of carrying an     inherited EGFR mutation in their normal cells as well. This represents a new strategy for     finding individuals and families carrying inherited EGFR mutations.      This research study is designed to find cancer patients whose tumors have this EGFR mutation,     T790M, to find out if they also have an inherited EGFR mutation. Subjects will not have to     undergo a biopsy to participate in this research study. Investigators will collect a saliva     specimen from patients with a T790M in their cancer to find out if they also have an     inherited EGFR mutation.      Study participants found or known to carry an inherited EGFR mutation will have the option of     offering their close relative the opportunity to also participate in this study. Close     relatives can consider testing to see if they also carry the inherited mutation in their     normal cells. Once investigators have identified individuals and relatives that carry     inherited EGFR mutations in their genes, investigators will then try to understand the risk     of lung cancer and other cancers. Individuals with inherited EGFR mutations will also have     the opportunity to participate in future studies related to cancer and other diseases.      This study is being funded in part by the Conquer Cancer Foundation of ASCO and the Bonnie J.     Addario Lung Cancer Foundation.   "
117061|NCT01753674|"     Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance and     plasma glucose in individuals classified with metabolic syndrome.   "
117101|NCT01753154|"     To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in     comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients     using the APD cycler sleep•safe.   "
117035|NCT01754012|"     NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving     nutritionists, bio-gerontologists, immunologists and molecular biologists from the most     prestigious institutions in Europe, 5 large food industries, 8 traditional food companies and     1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13     European countries and the European Confederation the food and drink industry. NU-AGE aims     are: 1. to counteract the physical/cognitive decline occurring in the elderly as a     consequence of the progressive alteration of different organs/systems (immune and     cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored whole     diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet, half     control) from 5 different EU regions; 2. to assess the effect of the newly designed food     pyramid specific for 65+ EU citizens on the different organs/systems using a large set of     biomarkers related to nutrition and aging, with particular attention to the low grade,     chronic, systemic inflammatory status named inflammageing, a major risk factor for common     age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high     throughput omics to identify cellular/molecular targets/mechanisms responsible for whole     diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual     variability on the response to diet; 5. to adopt an integrative comprehensive approach     (systems biology) to analyze the whole set of data. The results of dietary intervention will     be used to develop elderly-tailored prototypes of functional foods and to improve traditional     foods. The research activity will be accompanied and followed by a strong activity of     dissemination and industrial exploitation to support EU strategies on nutritional     recommendations, thus contributing to the implementation of legislation related to     nutritional and health claims for elderly in Europe.   "
117036|NCT01753999|"     The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder     in which there are problems with breathing during sleep) in World Trade Center Responders.     The study will look at the relationship between sleep apnea and various nose and throat     conditions. Specifically, the study will look at upper airway disease (problems with the nose     and throat), nasal inflammation, and nasal resistance (the amount of airflow through the     nose). Subjects will have a physical exam and answer questions about nasal symptoms and     sleeping problems. Nasal lavage (washing the inner nasal passages) will be performed on the     subjects and markers of inflammation will be measured in the lavage fluid. Rhinomanometry     (measuring the airflow through the nose) will also be performed to measure the degree of     airflow obstruction. All subjects will be asked to perform in-home sleep apnea monitoring.     Those subjects who are diagnosed with sleep apnea will test two treatment methods. Sleep     apnea is treated by using a CPAP (continuous positive airway pressure) device. This device     blows air into a mask worn by the patient during sleep. The two treatment methods that will     be tested are the fixed pressure CPAP (pressure is constant during use) and CPAP-flex     (pressure decreases when the subject exhales). Patients will be randomly assigned to one     treatment method for one month then crossed to the other treatment method for the next month.     The investigators will determine if patients with certain nasal conditions (high nasal     resistance) are more likely to use CPAP-flex rather than CPAP.   "
117037|NCT01753986|"     The investigators hypothesize that individuals receiving the brief substance use intervention     will have better substance use and intimate partner violence outcomes than individuals     receiving the general health improvement intervention. All participants receive standard     batterer intervention.   "
117038|NCT01753973|"     Metabolic syndrome (MS) is characterized by a series of metabolic and hemodynamic parameters     such as hypertension (hypertension), abdominal obesity, dyslipidemia, abnormal glucose     metabolism and insulin resistance, resulting in increased cardiovascular morbidity and     mortality and the risk for developing type 2 diabetes mellitus (T2DM). Metabolic syndrome is     a common event after renal transplantation. The prevalence of MS increases post-transplant     with weight gain. In renal transplant recipients, the SM is associated with CVD, diabetes     after transplantation, worsening renal function and graft loss. Immunosuppressant medications     have primary effect on the pathophysiology of MS. Several studies have evaluated the     prevalence and impact of metabolic syndrome in renal transplant recipients as obesity,     hypertension, dyslipidemia and use of immunosuppressants. The objectives of this study are to     determine whether the determination of the metabolic syndrome at 6 months predicts this same     condition at 12 months, determine the prevalence of metabolic syndrome at 12 months, to     assess the prevalence of obesity and overweight in this population and to assess the     prevalence of diabetes mellitus after renal transplantation. Patients who meet the inclusion     criteria and did not meet the exclusion criteria will be invited to participate in the study,     signing the Instrument of Consent (IC) and informed about the objectives and procedures of     the study to be performed, with age between 18 and 60 years, both sexes, renal transplant     recipients Renal Transplant Unit, Hospital das Clinicas, FMUSP living donor or deceased and     use of immunosuppressive regimen consisting of tacrolimus, mycophenolate sodium and     prednisone. Sampling will be conducted laboratory tests, filling out questionnaires on     quality of life and anthropometric measures.   "
117039|NCT01753960|"     The purpose of this study is to determine whether Noninvasive and Continuous Hemoglobin     Monitoring (NACHO) for Surgical Blood Management affects transfusion decision making     algorithm in the operating room.   "
117040|NCT01753947|"     Training on simulated models in a surgical skills laboratory has been shown to improve     technical performance in the operating room. Currently described simulation-based curricula     consist of trainees practicing the same tasks until expert proficiency is reached. It has yet     to be investigated whether individualized deliberate practice, where curricula tasks vary     depending on prior levels of technical proficiency, would translate to the operating room.      This randomized controlled trial effectively demonstrates that deliberate practice on a     virtual reality simulator results in an improvement in technical skills in a real clinical     situation. This enhances the feasibility of implementing simulation-based curricula into     residency training programs, and consequently has the potential to improve patient safety.   "
117041|NCT01753934|"     About the Study: This research study is being conducted to see if diabetic ketoacidosis has     any impact on learning, behavior and development in children with Type 1 diabetes mellitus.     If there is an impact, is it transient or persistent? Sixty to 80 children between the ages     of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a     non-sedated MRI scan of the head performed. The investigators will compare this to a control     group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus.     The children with Type 1 diabetes mellitus will not have any changes made to their current     diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood     glucose values as required by your doctor and bring their meter(s) for downloading to each     visit. The children with Type 1 diabetes mellitus should also tell your doctor about the     frequency of severe low and high blood glucose values.   "
117045|NCT01753882|"     The primary goal of the proposed clinical trial is to investigate the combined effects of     walking training and monoaminergic agents (SSRIs and TIZ) on motor function of individuals in     sub-acute (2-7 mo) human motor incomplete Spinal Cord Injury (SCI), with a primary emphasis     on improvement in locomotor capability. We hypothesize that the use of these drugs applied     early following SCI may facilitate independent stepping ability, and its combination with     intensive stepping training will result in improved locomotor recovery following incomplete     SCI. Loss of descending control via norepinephrine inputs following spinal cord injury can     impair normal sensorimotor function through depressing motor excitability and impairing     walking capacity. Replacing these inputs with drugs can alter the excitability and assist     with reorganization of locomotor circuits. Assessment of single-dose administration of these     agents has been tested in patients with motor incomplete spinal cord injury; only limited     changes in walking performance have been noted. The resultant onset of weakness and increase     in involuntary reflexes following motor incomplete SCI may partly be a result of damage to     descending pathways to the spinal cord that control the release of serotonin. In models of     SCI, for example, application of agents that simulate serotonin has been shown to change     voluntary motor behaviors, including improvement of walking recovery. In humans following     neurological injury, the effects of 5HT agents are unclear. Few previous reports indicate     improved motor function following administration of agents which enhance the available     serotonin in the brain, although some data suggests that increased serotonin may be     beneficial. In this application, we propose to study the effects of clinically used agents     that increase or decrease intrinsic serotonin activity in the brain on strength and walking     ability following human motor incomplete SCI. Using detailed electrophysiological recordings,     and biomechanical and behavioral measures, we will determine the effects of single or chronic     doses of these drugs on voluntary and involuntary motor behaviors during clinical measures     and walking measures. The novelty of this proposed research is the expectation that agents     that increase serotonin activity may increase abnormal reflexes in SCI, but simultaneously     help to facilitate motor and walking recovery. Despite potential improvements in voluntary     function, the use of pharmacological agents that may enhance spastic motor behaviors     following SCI is in marked contrast to the way in which drugs are typically used in the     clinical setting.   "
117046|NCT01753869|"     Lung disease is the predominant cause of morbidity and mortality in Cystic Fibrosis (CF) with     80% of deaths resulting directly or indirectly from pulmonary disease. Abnormal airway     clearance causes retention of mucus resulting in frequent chest infections. Physiotherapists     use different techniques to help clear mucus from the lungs of patients with CF. Inhaled     medications and airways clearance techniques (ACTs) are central to a CF patient's daily     treatment and are often coordinated.      Burden of treatment is a common reason for non-adherence in this patient group, and     streamlining of treatment timings is sought to optimize adherence whilst ensuring efficacy to     an often complex daily regimen of inhaled bronchodilators, nebulizers and ACTs. A gap in the     research exists as to the optimal timing of Hypertonic Saline (HTS) and ACT within the daily     regimen. A study to show whether the timing of HTS around ACT is significant, can better     inform patients and potentially allow more flexibility around their treatment regimen.      Lung Clearance Index (LCI) has shown good sensitivity to abnormalities in lung function     compared with spirometry and has demonstrated a treatment effect in other trials. LCI may be     a suitable tool therefore, to assess intervention strategies aimed at airways clearance in     CF. This study aims to compare the effects ACTs after HTS inhalation versus ACTs during HTS     inhalation as measured by LCI.      It is a randomized, crossover trial of ACTs after HTS inhalation compared with ACTs during     HTS inhalation in adult CF patients during day 10-14 of a hospital admission for treatment of     a pulmonary exacerbation. Patients will be randomized to receive 1 of the treatment session     options on the first day and the reverse on the second day.      The primary objective of this study is to compare the change in LCI (a measure of lung     function) at 90 minutes post treatment with ACTs after HTS inhalation compared with ACTs     during HTS inhalation in adult CF patients.      LCI (lung clearance index) ACT (airway clearance technique) HTS (hypertonic saline)   "
117047|NCT01753856|"     The purpose of this study is to determine how teriparatide or denosumab affects the bone of     postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone     biopsy sample taken from the iliac crest (upper part of the pelvis).   "
117048|NCT01753843|"     RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early     cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm     (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants     (n.a.p.i.) at 37 weeks of post conceptional age   "
117049|NCT01753830|"     The purpose of the study is to determine whether a single intra-articular injection of     Durolane is superior to a single injection of PBS for the relief of joint pain in patients     with osteoarthritis of the knee.   "
117050|NCT01753817|"     Radial artery occlusion may occur after performance of coronary catheterization via the     radial artery (transradial approach). In some cases it may be desirable to insert large (7F)     catheters via the radial artery, however the impact of increased catheter size on subsequent     radial artery patency is unclear. We hypothesize that radial artery occlusion following 7F     catheterization is rare and occurs in < 5% of the cases.   "
117051|NCT01753804|"     To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to     help inform the design of future studies, to capture biomarkers of safety and disease     progression and to provide comparative data for the development of rare exons for which     formal controlled trials are not feasible.   "
117052|NCT01753791|"     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of     PF-06473871 in normal healthy adults.   "
117053|NCT01753778|"     A proof of concept study to evaluate the feasibility of safe and effective treatment through     optimization of the Cryo-Touch III Device for temporary relief of pain.   "
117054|NCT01753765|"     A proof of concept study to evaluate the feasibility of safe and effective treatment through     optimization of the Cryo-Touch III device for temporary relief of or reduction in pain due to     occipital neuralgia.   "
117055|NCT01753752|"     In the elderly population, dry eye syndrome is a highly prevalent ocular disease. One     mainstay of therapy for patients suffering from dry eye syndrome is the use of topically     administered lubricants. One of the main disadvantages of the formulations currently     available for the treatment of DES is the short residency time on the ocular surface, which     increases the need for a frequent instillation of the lubricant.      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for     treatment of symptoms related to DES. Based on theoretical considerations and animal     experiments, the new chitosan derivative may show an increased adhesion to mucins of the     ocular surface and may therefore considerably increase the residence on the ocular surface.     This, in turn, would limit the need for frequent treatment and decrease the burden for the     patients.      It has been shown in recent Phase I studies that chitosan-N-acetylcysteine eye drops are safe     and well tolerated after single and repeated instillation. The current study seeks to     investigate the ocular residency time after a single dose and after 5 day b.i.d. treatment.     For this purpose 2 cohorts are planned: In Cohort I, chitosan-N-acetylcysteine eye drops will     be instilled once in one randomly chosen eye, whereas the fellow eye will receive placebo.     Measurements of tear film thickness will be performed with optical coherence tomography (OCT)     before instillation and 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours and     24 hours after instillation. In addition, ocular scattering of the tear film will be assessed     with an Optical Quality Analysis System (OQAS) at the same timepoints. Determination of break     up time (BUT) will be performed before and after instillation of the eye drops.      In Cohort II, chitosan-N-acetylcysteine eye drops will be instilled once daily in one eye and     b.i.d. in the fellow eye on five consecutive days. Measurements of tear film thickness with     OCT and OQAS will be performed every study day before the morning instillation and the day     after the last instillation. Additionally, patients will be asked to answer the ocular     surface disease index (OSDI©) on day 1 and day 6. BUT will be determined before and after     instillation of the eye drops.   "
117056|NCT01753739|"     This study will examine dose ranging characteristics of bepotastine besilate nasal spray     compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with     active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to     Mountain Cedar pollen for at least 2 years prior to the study.   "
117057|NCT01753726|"     Physical therapists have traditionally included various forms of manual therapy among the     therapeutic approaches to spinal pathologies. The aim of this study was to evaluate the     effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.   "
117063|NCT01753648|"     Recently, a new and sophisticated method for assessment of retinal blood flow and retinal     blood flow velocity profiles has become available. This technique is based on the combination     of measurement of retinal vessel calibers with bidirectional Fourier domain optical coherence     tomography (FDOCT). The valid measurement of retinal blood flow is of significant importance,     because it is known that major ophthalmic diseases, such as hypertensive retinopathy, are     associated with alterations in blood flow.      Hypertensive retinopathy is the most common manifestation of arterial hypertension in the     eye. Elevated systemic blood pressure leads to generalized arteriolar narrowing caused by     vasospasms and increased vascular tone. Further in the disease process, focal arteriolar     narrowing, retinal haemorrhages, hard exudates and cotton wool spots can occur. Previous     studies have shown that blood flow in the extraocular vessels and in the choroid is     compromised in patients with arterial hypertension. However, data on the impact of arterial     hypertension on retinal blood flow and retinal blood flow velocities are lacking.      The present study sets out to compare total retinal blood flow and retinal velocity profiles     in patients with hypertensive retinopathy and healthy age- and sex-matched controls. Ocular     perfusion pressure will be calculated based on measurements of blood pressure and intraocular     pressure to allow for calculation of vascular resistance. In addition, velocity profiles at     arterio-venous crossings will be measured. It is hypothesized that these velocity profiles     are considerably modified in patients with stage 2 and 3 hypertensive retinopathy compared to     healthy controls because of pronounced arterio-venous compression.   "
117064|NCT01753635|"     The purpose of this study is to compare the performance of the Baska mask supraglottic airway     device with a single use laryngeal mask device (LMA) in low-risk female patients.      The investigators have performed a number of studies on novel airway devices, including 3     studies on the Baska mask. This trial will compare some performance characteristics of the     studied devices, including airway seal pressures, insertion success rates, device use     difficulty scores. Additional performance and device safety data will be accumulated.      The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement     attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask     vs LMA.   "
117065|NCT01753622|"     Obesity and overweight have become an epidemic in the world and its prevalence between     pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also     associated with depression disorders and its serious complications during this period.   "
117066|NCT01753609|"     The study will assess the safety and performance of an intragastric auto-inflating and     degradable balloon   "
117067|NCT01753596|"     Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for     the patients reaching from ocular discomfort in its simplest form up to visual impairment and     corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a     common disease, especially in the elderly population, affecting up to 20% of adults aged 45     years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear     film thickness and the corneal residence time are lacking.      Recently, a new objective method for assessment of tear film thickness by optical coherence     tomography has been developed. The present study aims to investigate the corneal residence     time of an established topical lubricant compared to placebo in patients with DES and healthy     controls.   "
117068|NCT01753583|"     Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical     practice. The current study seeks to investigate whether high-resolution OCT is suitable for     imaging of these corneal lesions. The present study has the character of a pilot study and     the results are intended to be used to develop a standardized protocol for imaging and     analysis of these corneal lesions. Based on this protocol, further studies investigating the     pathophysiology of corneal lesions or evaluating therapeutic success can be planned.   "
117069|NCT01753570|"     This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients     with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.   "
117070|NCT01753557|"     This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in     patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after     previous treatment.   "
117071|NCT01753544|"     We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic     submucosal dissection of gastric neoplasia.   "
117072|NCT01753531|"     The clinical performance of the Ultra Influenza A&B Test will be demonstrated during a     clinical trial in which prospectively collected nasal swabs are used in identifying subjects     who are infected with the influenza virus strain type A or type B. The Ultra Influenza A&B     Test qualitative results will be compared to Gold Standard viral culture with Direct     Fluorescent Antibody (DFA) confirmation techniques using nasal swabs collected from     symptomatic subjects. The Ultra Influenza A&B Test will be performed at Clinical Laboratory     Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. nurses,     physician assistants, medical assistants, etc.). For viral culture testing with DFA     confirmation testing, nasal swab specimen testing will be performed by a designated reference     laboratory.   "
117073|NCT01753518|"     Currently, the way doctors close the skin during cesarean section is different between     surgeons and there is little evidence to support the use of one kind of closure over the     other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable     suture (or stitch), placed within the top layer of skin. At other institutions, a metal     staple is often used to close the skin.      There is a new technique that uses special absorbable staples just beneath the skin. This     technology may be equal to, or possibly better than, current skin closure techniques.     However, there is currently little data to show how it compares. The purpose of this study is     to compare the absorbable staple to the currently used absorbable suture. The data from this     study will then be used to help determine the best technique for skin closure.   "
117074|NCT01753505|"     The aim of this study is to evaluate the clinical usefulness of 64-slice multidetector     coronary CT angiography (MDCTA) in renal transplant recipients who had no previous coronary     artery disease (CAD). Primary endpoint is to assess the prevalence and severity of coronary     artery disease in patients post-transplant 6 to 12 months. CAD can be diagnosed noninvasively     with similar accuracy of coronary angiography using MDCTA. Early detection and intervention     of CAD may provide survival benefit in renal transplant recipients.   "
117075|NCT01753492|"     Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma.     Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to     prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs,     and increased risk to infection, blebitis and endophthalmitis.      Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant     (Ologen), has become available for glaucoma surgery.Although a few studies on filtering     surgery with Ologen implantation have been performed, there is yet no conclusive evidence on     effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.      This is a prospective intervention pilot study to determine the degree of intraocular     pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to     trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of     the two procedures will be compared.      The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than     trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.   "
117076|NCT01753479|"     Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to     adenocarcinoma patients.   "
117077|NCT01753466|"     The investigators are conducting a six-week randomized controlled pilot trial to assess the     feasibility and safety of increased water intake in patients with chronic kidney disease.The     investigators will study 30 patients (age 30 to 80 with an estimated glomerular filtration     rate between 30 and 60 ml/min/1.73m2 and microalbuminuria [albumin to creatinine ratio >2.8     mg/mmol (if female) or >2.0 mg/mmol if male)].The investigators will randomize patients (in a     2:1 ratio) to a fluid-intervention group or control group. Participants who are randomized to     the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day     (depending on sex and weight) in addition to usual consumed beverages, for 6 weeks.     Participants in the control group will be advised to consume their usual amount of fluid.      The investigators hypothesize that patients will be able to increase and maintain a higher     fluid intake with stable blood chemistry, particularly serum sodium.   "
117078|NCT01753453|"     The primary objective of this study is to evaluate tumor cell mobilization (TCM) with     non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with     multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).      Second objectives are to evaluate survival and disease status of G-CSF alone compared with     GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to     mobilize stem cells for autologous transplantation.   "
117079|NCT01753440|"     The aim of the present study is to investigate safety and efficacy of intramyocardial     implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy at     the time of coronary artery bypass grafting.   "
117080|NCT01753427|"     The objective of the study is to assess patient's perception with stable state COPD on     symptom variability and to describe how symptom variability impacts daily quality of life in     Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3     hospitals in China where most of COPD patients are diagnosed and treated.   "
117081|NCT01753414|"     Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung     cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer     but higher and possibly more effective doses of radiation than standard radiation. This     technique may be able to send x-rays directly to the tumor and cause less damage to normal     tissue. It is not yet known whether stereotactic body radiation therapy is more effective     than surgery in treating non-small cell lung cancer.      Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy of     SBRT is comparable to that of standard surgical interventions for patients with T1N0     non-small cell lung cancer.   "
117082|NCT01753401|"     This Phase 4 study is being performed to examine the effects of Acthar for the indicated use     of treatment of SLE. This study will enroll patients with steroid-dependent, persistently     active SLE with arthritic and/or cutaneous involvement. The study will involve two phases: a     double-blind phase, to provide placebo-controlled safety, efficacy, and pharmacodynamic data,     and an optional open-label phase, to examine the prolonged effects of Acthar maintenance.   "
117083|NCT01753388|"     The purpose of this study is to assess the safety and performance of the Penumbra Liberty     Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial     aneurysms.   "
117096|NCT01753219|"     The objective of this study is to evaluate chronic pain and sexual dysfunction after inguinal     hernia repair involving mesh fixation with sutures (Lichtenstein) compared with no mesh     fixation (Onstep). The study hypothesis is that a smaller proportions of patients operated     without mesh fixation (Onstep) will have chronic pain that impairs daily function.   "
117123|NCT01752868|"     The purpose of this study is to determine if a combination of 10 nutritional supplements     provide health benefits that are consistent with protection against age-related disease. All     supplements have been shown in previous studies to have health benefits when administered     alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will     provide beneficial changes in healthy related measures.   "
117084|NCT01753375|"     Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical     cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing     relapses and disease progression, prospective randomized control trials are nevertheless     necessary to confirm these statements and to determine the most efficacious, safe, and the     minimum required doses. This hypothesis is going to be tested through a randomized triple     blinded controlled trial in which after randomization, one group of patients will receive     vitamin D and second group will receive placebo. Both groups are going to be followed in a     similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels     is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning     and end of trial.The number of relapses and the physical disability will be calculated     through the Expanded disability status scale (EDSS).   "
117085|NCT01753362|"     The purpose of this study is to examine the effects of liraglutide (a drug used to treat type     2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to     insulin.   "
117086|NCT01753349|"     The purpose of the study is to document long-term response in real-life practice after     injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia     (Long-term clinical and pharmaco-economic data).   "
117090|NCT01753297|"     The purpose of this study is to assess the benefit of immediate hormonal treatment after     Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To     reach this target, the trial will compare a group of patients treated with triptorelin at 8     weeks after the surgery and for a duration of 9 months (3 injections) versus another group     (called active surveillance group) who will be not receiving triptorelin. Both groups will     be followed every 3 months to monitor any sign of disease progression during a minimum of 36     months   "
117091|NCT01753284|"     First episode psychosis patients often experiences treatment delay. This reduces their     prospects for recovery and makes unnecessary burdens for them and their carers. A better     understanding of help seeking intentions is required, and has not been explored in a county     like Nordland, Norway, with long distances and challenging access to health services. The     purpose of this study is to explore the process of help seeking, including how patients and     their careers discover and understand the psychotic symptoms. Research exploring the impact     on families mainly focuses on parents` experiences, and there are less studies focusing on     experiences and needs of siblings. This study will therefore explore siblings` experiences     separate from their parents. Methods will be qualitative interviews with patients, their     carers and siblings. Analysis will be influenced by Grounded theory.   "
117092|NCT01753271|"     Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic     spinal manipulation in addition to shoulder mobilization and exercise for improving range of     motion, pain, physical function and fear avoidance beliefs in patients with subacromial     shoulder impingement.      Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition     to shoulder mobilization and exercise will achieve greater improvements in range of motion,     pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4     weeks following treatment conclusion, and at discharge when compared to the subjects who did     not receive the spinal manipulation.   "
117093|NCT01753258|"     The focus of this pilot study is to determine if a woman who experiences pain during sexual     intercourse has a higher risk of complications during labor and delivery secondary to pelvic     floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is     unclear whether women with prepartum dyspareunia experience an improvement following vaginal     delivery. While physicians may expect that vaginal birth improves dyspareunia due to the     stretching effect on pelvic floor, to date, there is insufficient evidence to support this     claim. The Investigators plan to prospectively study 200 patients at our Institution, collect     information regarding birth and follow them, via questionnaires, regarding their dyspareunia     postpartum.   "
117094|NCT01753245|"     It has been reported in various epidemiological studies that patients with moderate-to-severe     plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency     of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus     (T2DM, and metabolic syndrome (MetS). The presence of endothelial dysfunction in early     stages, especially in moderate-to-severe plaque psoriasis forms, could explain the higher     prevalence of cardiovascular disease and mortality observed in this population. Existing     evidence showing improvement in psoriasis after correcting some factors, such as obesity or     hypercholesterolemia, and the reduction of certain surrogate markers of cardiovascular risk     with different modalities of psoriasis treatment suggest a biological interaction between the     two diseases beyond mere epidemiological association. Recently published results support this     hypothesis and suggest that the link between psoriasis and cardiovascular disease could be     the existence of an inflammatory state in different organs, including skin, joints, adipose     and hepatic tissue, and vascular endothelium (16). Patients with MetS have an increased risk     of developing T2DM and cardiovascular disease. This syndrome is characterized by the     association of an adipose tissue inflammatory state and diminished sensitivity to insulin. In     recent years, a new mechanism participating in the development of MetS has been added: the     Wnt signaling pathway. Polymorphisms in genes of the Wnt signaling pathway have been     associated with metabolic abnormalities that predispose to cardiovascular disease, the     development of moderate-to-severe plaque psoriasis, with or without associated psoriatic     arthritis, and response to treatment with anti-TNF-alpha.      This study aims to describe the cardiovascular risk factors of a Spanish population of     patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic     arthritis,treated with anti-TNF under routine clinical practice conditions. Possible     differences in efficacy relative to the presence or absence of criteria of metabolic syndrome     will be analyzed. Similarly, we will explore the role of markers of inflammatory activity and     genetic polymorphisms in the Wnt pathway in predicting response to treatment during the first     year.   "
117095|NCT01753232|"     Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a     patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and     then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole     blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The     MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma     which is cleaned by filtration. This study comprises the recording of safety and efficacy     data from patients treated either with the DALI or MONET-system over a period of 2 years.   "
117097|NCT01753206|"     Study Objectives The study is to identify prevalence, demography and clinical characteristics     of patients with resistant hypertension among hypertensive patients who have been treated in     general hospitals in Korea from Jan 2012 to Jun 2012.        -  Diagnosis of resistant hypertension: In case of clinic blood pressure exceeding the          boundary of systolic blood pressure at 140mmHg and diastolic blood pressure at 90mmHg          (hereinafter refer to as 140/90mmHg) (130/80mmHg for patients with diabetes mellitus or          chronic renal disease) despite triple antihypertensive therapy at optimal dose may be          diagnosed as resistant hypertension. Antihypertensive medications used include          diuretics. Resistant hypertension may also be diagnosed when clinic blood pressure has          reached the target value but quadruple or more of antihypertensives are used.        -  Diagnosis of controlled hypertension: Patients whose clinic blood pressure equals to          140/90mmHg (130/80mmHg for patients with diabetes mellitus or chronic renal disease) or          less with the administration of antihypertensives at optimal dose may be diagnosed as          controlled hypertension.   "
117098|NCT01753193|"     The purpose of this study is to evaluate the long-term safety of MEDI-546 in adults with     moderate to severe active systemic lupus erythematosus   "
117099|NCT01753180|"     A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study,     evaluating acute intra-coronary injected collagenase prior to routine standard-of-care     percutaneous revascularization procedures in subjects with chronic total coronary artery     occlusions (CTOs).   "
117100|NCT01753167|"     This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the     safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in     cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive     donor, with use of a preemptive approach for prevention of CMV disease. Participants will be     randomized into two treatment groups: active or placebo control; both arms will be followed     preemptively. The study has a planned enrollment of approximately 120 participants (60 active     and 60 placebo).   "
117102|NCT01753141|"     The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused     on helping people manage their anxiety while quitting smoking. The study involves coming in     to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2,     month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50     for their full participation as well as receive 6 weeks of free nicotine replacement patches.   "
117103|NCT01753128|"     Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease     (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic     antidepressant improves NERD patient's symptoms remains unknown      Aim of this randomized controlled trial study is to determine the efficacy of imipramine,     which could increase esophageal pain thresholds in healthy volunteers, in comparison with     placebo for treatment patients with esophageal hypersensitivity or functional heartburn     evaluated by improvement of specific-symptom score and quality of life   "
117104|NCT01753115|"     The purpose of this clinical trial is to determine whether there is any effect on the     antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of     BioThrax® (Anthrax Vaccine Adsorbed or AVA).      This study will be conducted in the United States (US) in 154 healthy male and female     volunteer subjects ages 18 to 45.      The duration of study participation for each subject will be approximately 76 days     (approximately 2.5 months)   "
117105|NCT01753102|"     Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing     17ß-estradiol.      The estradiol in estradiol vaginal tablet is chemically and biologically identical to the     endogenous human estradiol and is therefore classified as a human estrogen.      The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's     Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is     approved and marketed in the US.   "
117106|NCT01753089|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of     the investigational vaccine, in this case WDVAX, to use for further studies.     Investigational means that the vaccine is still being studied and that research doctors are     trying to find out more about it. It also means that the FDA has not yet approved WDVAX for     any use in patients, including people with Melanoma.      The purpose of this study is to determine if it is possible to make a vaccine against     melanoma by using your own melanoma tumor cells and combining them with other proteins which     activate the immune system. We hope that by combining the cells and the proteins in this way     that the vaccine will cause your own immune system to react against your melanoma tumor     cells. The purpose of this study is also to determine the safest way to give this vaccine     with the least amount of side effects.      Each vaccine will contain your own tumor cells which have been killed by a freezing and     thawing process which destroys the cells but keeps the proteins from the melanoma cells. This     is called a tumor lysate Your tumor lysate is combined with other proteins which activate     the immune system. The other proteins are called GM-CSF and CpG. All of this is held together     to form a tablet or scaffold which is about the size of a regular aspirin tablet. The     material that holds the protein together is called PLGA. PLGA is the same material that     doctors use for dissolvable stitches If you have ever had a problem with these types of     stitches in the past, be sure to let your study doctor know about this.   "
117120|NCT01752907|"     The purpose of this study is to determine if patient education can affect patient reported     bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.   "
117121|NCT01752894|"     The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs.     Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES vs BES     implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement at     3 months   "
117124|NCT01752855|"     A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed     to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed     new adalimumab formulation.   "
117107|NCT01753076|"     This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group     investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared     to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period     of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15     milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a     follow-up visit around 14 weeks after the last infusion. A total of approximately 294     eligible subjects will be randomised from approximately 37 centers worldwide. The primary     objective is to assess the effect of ozanezumab on the physical function and survival of ALS     subjects over a treatment period of 48 weeks. Function will be measured using the ALS     Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of     other clinical outcomes associated with ALS (respiratory function, muscle strength,     progression free survival and overall survival) in support of the primary objective. Quality     of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole)     will also be assessed.   "
117108|NCT01753063|"     As part of Children's Hospital Association's Focus on a Fitter Future III Obesity Task Force,     this project will target patient and family expectations across the domains of nutrition,     physical activity and behavior change/family support as a means of patient engagement and     retention in pediatric weight management. This will be a prospective, non-randomized,     uncontrolled, single-arm trial for children between 2 and 18 years of age and a     parent/guardian, who are starting a pediatric weight management program/clinic in one of the     participating centers. The parent/guardian and child if 12 years of age or older receive a     survey at the first visit, which asks about their expectations and goals for the visit. This     information will then be used as part of clinical care to tailor treatment. After 3 months,     the parent/guardian and adolescent, if applicable, will receive a follow up survey asking     about their progress in these areas.   "
117166|NCT01752309|"     Rheumatoid arthritis a chronic and progressive inflammatory disease characterized by synovial     membrane inflammation, possibly leading to destruction of joints. To start early with a     combination therapy results in a better outcome for patients. Using ultrasonography it is     possible to detect clinically and radiographically absent synovitis and erosions. However, it     is unclear whether or not these findings have predictive value in these patients regarding     disease activity or radiographical progression.   "
117109|NCT01753050|"     Several studies have demonstrated that goal-directed fluid therapy during high- risk-surgery     reduces morbidity and length of hospital stay. This quality improvement is design to evaluate     the implementation of an intraoperative goal-directed therapy, using a pulse contour analysis     monitor to optimize the stroke volume, in patients undergoing redo-hip-surgery. The primary     combined endpoints will be the incidence of postoperative complications and the secondary     endpoints will be the decrease of hospital length of stay, length of ICU stay and hospital     postoperative mortality. We amended another 130 patients getting crystalloid fluids in the     hemodynamic optimization protocol.   "
117110|NCT01753037|"     The hypothesis of this study is that DHEA administration to increase male hormone in healthy     normal-weight young women to levels present in women with Polycystic Ovary Syndrome will     cause an inflammatory response in white blood cells in the fasting state, and in response to     glucose ingestion.   "
117111|NCT01753024|"     Malnutrition is a frequent problem in critically ill patients that is associated with     detrimental clinical outcomes. To provide adequate nutritional support, current studies     focused mostly on the choice of delivery timing, formula selection and the route of     administration, little attention was paid to malnutrition related to exocrine pancreatic     insufficiency (EPI).      In fact, malnutrition is also a major consequence of pancreatic exocrine insufficiency and     pancreatic damage is commonly observed in critically ill patients without prior pancreatic     diseases. Hence, EPI associated malnutrition should be concerned due to the high prevalence     of pancreatic damage in critically ill patients.      The aims of this study is to evaluate the incidence of EPI in critically ill adult patients     and explore its potential risk factors. Moreover, the efficacy of pancreatic enzyme     supplementation therapy on malnutrition in ICU patients with specific clinical     characteristics will be investigated.   "
117112|NCT01753011|"     This is a prospective, observational, multicenter study of women with surgically-correctable     stress urinary incontinence who undergo a TOT-sling operative procedure.   "
117113|NCT01752998|"     Individuals will be recruited by posted advertisements in the waiting rooms of the PCP     offices and by physician referral. After an initial phone screen, research staff will meet     with interested individuals in their PCP offices for informed consent, baseline interview and     randomization. Participants will be randomized into a Health Education study arm, and receive     7 individual sessions on general health education, or an Intervention study arm, and receive     7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention.   "
117114|NCT01752985|"     The purpose of this study is to determine whether BMS-813160 will reduce the amount of     protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease   "
117115|NCT01752972|"     Patients of arsenical keratosis may be treated with spirulina. Is this improvement related to     the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? To     understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls     (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally     for 12 weeks. Skin extracts will be collected both before and after supplementation from the     palm and dorsum for estimation of zinc, vitamin E and linoleic acid levels.   "
117116|NCT01752959|"     In this prospective randomized study we aimed to compare the effects of esmolol and     remifentanil on intraoperative bleeding surgical field conditions in nasal surgery   "
117117|NCT01752946|"     The purpose of this study is get to know what and how Shuxuening injection in hospital     results in adverse events or adverse drug reactions from a cohort event monitoring.   "
117118|NCT01752933|"     A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced     hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a     Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at     16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease     control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC     after failure of prior sorafenib.   "
117119|NCT01752920|"     This is an open-label, Phase 1/2, dose escalation and signal finding study of ARQ 087     administered to subjects with advanced solid tumors with FGFR genetic alterations, including     intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusion. The study is designed to     explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary     efficacy of ARQ 087 and to define a RP2D of ARQ 087.   "
117126|NCT01752829|"     The laparoscopic adjustable gastric band (LAGB) is a safe and effective surgical intervention     for chronically obese patients who have exhausted all non-surgical weight loss treatments.     Numerous published studies have confirmed both the safety and efficacy of the LAGB and its     beneficial impact on obesity-associated conditions, such as type 2 diabetes, joint and back     pain and hypertension. The A.M.I. Protector Band is a modification of an existing gastric     band (the A.M.I. Soft Gastric Band) which has been in use since 2001 and which has been shown     to be both safe and effective. The specific design modification is in the form of a section     of mesh, which provides support to the gastric pouch and which further restricts food portion     sizes. The expectation is that this will deliver optimal weight loss whilst having the     maximum possible impact on obesity-associated conditions such as type 2 diabetes and     hypertension. In the longer term, there is also the possibility that the Protector Band will     reduce the incidence of band complications such as slippage and dilatation (or stretching) of     the gastric pouch. In this study we will recruit approximately 200 patients who will then     undergo surgical implantation of the A.M.I. Protector Band. The study participants will then     be followed for a period of 3-years, during which time we will record weight loss, changes in     co-morbid conditions such as diabetes and the incidence of band complications, including     slippage and pouch dilatation.   "
117127|NCT01752816|"     In healthy young subjects a single bout of strength training following endurance training has     been shown to improve markers for aerobic capacity in muscle compared to a single bout of     endurance training alone. The present project tests the hypothesis: 12 weeks of training with     sessions of endurance training followed by strength training is superior to endurance     training alone for health participants 50-65 years of age. The outcome measures are maximal     oxygen uptake and knee-extension strength.   "
117775|NCT01744340|"     The purpose of this study is to determine if the full dose of eribulin mesylate can be safely     given with the full dose of cetuximab. The activity of the combination of eribulin mesylate     and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.   "
117128|NCT01752803|"     Background: The connection between gut health and diabetes status is increasingly recognized.     Gut microbiota composition in diabetic differs from non-diabetic individuals. Interestingly,     the level of glucose tolerance was associated with specific microbiota that was rarely found     in healthy individuals. Probiotics is one of the functional foods believed to mediate their     health promoting activities through modulating the composition of the gut health. Ingestion     of probiotics has been shown not only to influence gut microbiota composition but also the     secretion of the gut hormones and insulin resistance in animal models with limited trials in     human. Supplementation with probiotic has also been shown not only affect glucose     homeostasis, but improved other diabetes related comorbidities such as obesity, hypertension,     and hyperlipidemia.      Objectives and hypotheses: To address this research gap, this Randomized Controlled Trial     (RCT) is proposed to determine the efficacy of probiotic supplementations as adjuvant therapy     to improve glucose homeostasis through modulating gut microbiota composition and gut hormones     secretion in individuals with type 2 diabetes. We hypothesized that the probiotic     supplementations will improve blood glucose control as well as other diabetes related     co-morbidities in individuals with type 2 diabetes.      Methodology: This is a double blind randomized parallel group control trial with 3 months     probiotic supplementation or placebo. After screening the eligible subjects will be selected.     Then, after consent taking, subjects will be randomly assigned to either receive probiotic or     supplement for 3 months. Measurements of blood parameters including glycemic control related     parameters, lipid profile, renal profile, and liver function tests as well as three day diet     recall, and anthropometry measurements will take place at baseline, after 6 weeks and after     12 months.      Expected Outcomes: Probiotic supplementation as an adjuvant therapy would improve glucose     homeostasis and gut health as compared to the placebo and eventually will beneficially affect     other diabetes related conditions. This study would provide avenue to identify the     possibility of probiotic supplementations as an adjuvant therapy in the management of type 2     diabetes.   "
117129|NCT01752790|"     Crohn's disease (CD) is an incurable debilitating disorder affecting an increasing number of     children. The etiology remains elusive, but a genetically determined aberrant immune response     against microbiota appears to be responsible. TNFα plays a pivotal role in the cytokine     cascade of the inflammatory process and mediates multiple processes central to the     pathogenesis of CD. The natural history of pediatric CD is characterized by recurrent     flare-ups that severely impair patients growth, pubertal development and nutritional status.     Epidemiological observations have shown that the course of CD, despite conventional     treatment, inevitably progresses to the development of severe complications and surgery.     Infliximab is the most widely used biological agent in moderate-to-severe pediatric CD. At     present biologics are used after the failure of conventional drugs (step-up approach) and     represent the peak of the CD therapeutic pyramid. The early use of biologics (top-down     approach) has been demonstrated to be effective in adults with CD. The project aims at     evaluating if a top-down approach may achieve mucosal healing before irreversible tissue     damage present in late CD and thus alter the natural course of the disease, compared to the     conventional approach. The study can also add information about the safety of infliximab used     as first-line therapy and may add data on the benefit and costs of a reversal of the     traditional therapeutic pyramid in pediatric CD, guiding the clinician in deciding in whom,     when and how to introduce early aggressive treatment in daily practice.   "
117130|NCT01752777|"     Prevention strategies that aim to test and treat people for HIV infection are undermined by     HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study     will test a theory-based behavioral intervention to reduce HIV infectiousness by     simultaneously improving HIV treatment adherence and reducing sexually transmitted     co-infections in people living with HIV-AIDS who use alcohol and other drugs. The     intervention is delivered in a single office-based counseling session followed by 4 cell     phone delivered counseling sessions in a model that will be ready for immediate dissemination     to case management and clinical services for people living with HIV/AIDS in resource     constrained settings.   "
117131|NCT01752764|"     The hypothesis will be tested that fat can also increase absorption of (non)-nutrients from a     salad. Therefore we designed the current study to show an increase in relative absorption     (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing.   "
117132|NCT01752751|"     A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in     non-radiation oncology clinical settings to predict how older adults tolerate cancer     treatments. The investigators think this same tool (referred to as the CGA) can be used in a     radiation oncology clinic to predict for poor treatment tolerance.   "
117163|NCT01752348|"     The investigators hypothesize that the investigators can detect protein-sparing effects of     administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an     acute inflammatory disease. The investigators use the infusion of endotoxin, US standard     reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate     the effect on protein metabolism using different tracers and the investigators can measure     the various intracellular signaling pathways of selected muscle and adipose tissue.   "
118274|NCT01737840|"     The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine     in treating patients presented with dyspepsia to the emergency department.      The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating     patients presented with dyspepsia to the emergency department.   "
117133|NCT01752738|"     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are     among the most extensively studied gut microbial metabolites, and are associated with     cardiovascular disease, chronic kidney disease progression and overall mortality. Mechanisms     governing their intestinal uptake and metabolism, however, are currently unknown. The     investigators aim to explore these transport characteristics in depth. Therefore, colonic     biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to     available data of healthy controls. Insights in the mechanisms controlling intestinal     transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it     might lead to novel therapeutic targets in the treatment of chronic kidney disease.   "
117134|NCT01752725|"     The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified     thermofu-sion and dissection instrument BiCision® in comparison with the long established     Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy     (LASH).   "
117222|NCT01751568|"     People who are infected with HIV and tuberculosis (TB) need to receive medications that treat     both diseases safely and effectively. This study will enroll infants and children infected     with HIV and TB and evaluate the safety and tolerance of an antiretroviral (ARV) treatment     regimen for HIV that contains raltegravir when administered with a TB treatment regimen that     includes rifampicin. Study researchers will also determine the most effective dose of     raltegravir for infants and children when it is taken with rifampicin.   "
117135|NCT01752712|"     A significant proportion of people with schizophrenia are characterized by impaired ability     to socially engage with others, which may reflect social aversion secondary to defeatist     beliefs; decreased motivation for social interactions; and/or impairment in the normal     reinforcement value of social interactions. These impairments in social function have been     shown to be associated with social skill deficits; and decreased ability to identify and     remember emotional facial expressions and empathize with the emotional status of others.     Unfortunately, pharmacological interventions have limited benefits for impaired social     function, whereas psychosocial interventions provide only partial benefit for this critical     aspect of the illness. The development of an effective intervention for functional outcomes     remains a central therapeutic challenge. Cognitive Behavioral Social Skills Training (CBSST)     uses corrective feedback and reinforcement provided by successful interactions to challenge     and reduce defeatist performance beliefs that contribute to low drive and interfere with     social functioning. CBSST has been shown to have modest effects on social function in people     with schizophrenia. Oxytocin plays a critical role in the regulation of normal social     affiliative behavior; it is hypothesized to enhance social affiliation through the reduction     of anxiety or social risk aversion; the enhancement of motivation for prosocial approach     behavior; and/or increased modulation of the salience and processing of social cues. People     with schizophrenia have decreased oxytocin levels, which are associated with an impaired     ability to identify facial emotions and decreased prosocial behaviors. The study will be     comprised of three phases: 1) 2-week Evaluation Phase; 2) 24-week Double-blind Treatment     Phase; and 3) 3-month Follow-up Phase.   "
117136|NCT01752699|"     Neuropathic pain is a common condition and affecting 40 to 70% of the general population.     Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment.     Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose     methadone in post-herpetic neuralgia patients who remained refractory after first and second     line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an     opioid agent to their current drug regimen.   "
117137|NCT01752686|"     This study is designed to investigate the efficacy of carboplatin, as a post-operative     adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual     cancer after the preoperative chemotherapy.   "
117138|NCT01752673|"     Medical reasoning is a form of inquiry that examines the thought processes involved in making     medical decisions. When physicians are faced with patients' symptoms or signs, their thought     processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more     analytic process to reach a diagnosis. The second pathway is less prone to biases and errors.     This study explores whether the use of an interactive visual display of probabilities of     pulmonary embolism generated from positive or negative test results will increase the     adherence to evidence based guidelines in the diagnosis of pulmonary embolism.   "
117139|NCT01752660|"     In the last decade physical exercise has become an accepted and integrated part of     rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated     whether the most severely disabled patients can tolerate and benefit from exercise therapy.     The purpose of this study is therefore to evaluate the feasibility of endurance training in     severely disabled patients with MS.   "
117140|NCT01752647|"     This prospective cohort trial was planned to assess the feasibility of establishing a lung     cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic     patients with at least a 30 pack-year history of cigarette smoking.   "
117141|NCT01752634|"     This study is to provide 24 - 52 week efficacy, safety and tolerability data to support the     registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self     administration in subjects with active PsA despite current or previous NSAID, DMARD and/or     anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data will be     collected during the post Week 52 period of the study.   "
117142|NCT01752621|"     Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.   "
117143|NCT01752608|"     The primary objective of this study is to evaluate the safety and efficacy of an electronic     cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting     of a mood monitoring handheld computer application in the treatment of patients with mild to     moderate major depressive disorder.   "
117164|NCT01752335|"     The purpose of this study is to determine whether tocilizumab changes the cardiovascular risk     factors on patients with arthritis rheumatoid.      Study hypothesis: the IL-6 contributes to increase the cardiovascular risk factors of     patients with rheumatoid arthritis because it produces systemic effects as increasing weight     and atherogenic body fat, changing energy homeostasis and inducing the adipokines production     and the insulin resistence.   "
117165|NCT01752322|"     The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated     plaster in localized chronic post-operative neuropathic pain in comparison to placebo     plaster.   "
118275|NCT01737827|"     This study is to find out if INC280 is safe and has beneficial effects in patients with     advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway.   "
117176|NCT01752179|"     Kinesio taping is a novel method which recently has emerged as a viable option to treat of     various musculoskeletal and neuromuscular deficits. The application of tape to injured soft     tissues and joints provides support and protection for these structures. Many different     techniques are used for injury prevention, treatment, rehabilitation, proprioception and     sport. Elastic adhesive tape may be used to unload Myofacial Trigger Points (MTrPs), A     trigger point can be located in fascia, ligaments, muscles, and tendons; however, MTrPs are     also found in skeletal muscles and/or their fascia. An MTrP is a hyperirritable spot,     associated with a taut band of a skeletal muscle that is painful on compression or stretch,     and that can give rise to a typical referred pain pattern as well as autonomic phenomena. The     use of tape along muscle to unload affected soft tissue seems to be effective in the     treatment of trigger points by inhibiting overactive muscle, changing the orientation of     fascia and a proprioceptive effect. The purpose of study was to determine the efficacy of     Kinesio taping application on trigger point of piriformis muscle.   "
117223|NCT01751555|"     This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and     safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human     immunodeficiency virus-1 and hepatitis B virus coinfection.   "
117144|NCT01752595|"     Auditory motor-coupling has been shown to induce neural-entrainment that can synchronize     walking-pace with sonic tempo. The extent to which acoustical-motor entrainment can induce     longer-term changes to physical activity behaviours remains unclear.      Cardiac rehabilitation is essential and is associated with irrefutable mortality benefits for     patients following an acute cardiac event. Randomized clinical trials have demonstrated a     25-50% improvement in survival as compared to controls; however, as many as 50% of patients     will dropout of such programs prior to completion, which undermines these morbidity and     mortality benefits (37; 54). Research exploring ways to improve compliance to such programs     has suggested that the incorporation of music and other such holistic, patient-centered     interventions into a rehabilitation/exercise program is associated with improved motivation,     endurance and satisfaction amongst cardiac rehabilitation participants. The MAINTAIN study     has been designed to conduct a feasibility evaluation on the effects of a preference-based     music intervention on adherence to the cardiac rehabilitation program at Toronto     Rehabilitation Institute. The primary objective of the trial is to evaluate the feasibility     of the implementation of such a protocol within the context of the program.      This is a two-arm, block 2:1 randomized trial. 35 patients participating in cardiac     rehabilitation at Toronto Rehabilitation: Cardiac Rehabilitation and Secondary Prevention     Program will be recruited and participants will be randomized into: 1) control (standard,     usual care); and, 2) music intervention. The randomization process employed will be a blocked     2:1 strategy, whereby subjects are randomized to the music treatment arms 2:1. All those     patients randomized into arm 2 will be equally randomized into either (2) preference-based     music intervention, (3) preference-based music enhanced with RAS. The primary outcome measure     will be weekly physical activity over a 3 month duration as measured using tri-axial     accelerometers. We will also analyze the impact of a preference-based music intervention     based on audio playlist utilization, self-reported sitting times ,exercise-times, on-site     attendance to the cardiac rehabilitation program (attendance), peak oxygen uptake (VO2)     (stress-test), and self-efficacy levels (self-efficacy questionnaires). These measures will     be collected and analyzed throughout the course of the intervention (3 months).   "
117145|NCT01752582|"     The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in     terms of the extent of neointima formation at 3 months after implantation using OCT.      This is a prospective, single center, randomized, open-label, non-inferiority study, which     will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned     undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was     met, superiority test will be planned.   "
117146|NCT01752569|"     Cancer is a leading cause of death in individuals living with human immunodeficiency virus     (HIV), and Kaposi's sarcoma (KS) remains the commonest HIV-associated cancer. KS is caused     when individuals become infected with both HIV and another virus, Human herpesvirus-8     (HHV-8). Laboratory studies have shown that HHV-8 can stimulate biological pathways within KS     lesions which promotes their growth. Selumetinib targets these pathways and may therefore be     a useful new therapy for KS. Phase I of this trial aims to identify the best dose for the use     of selumetinib and investigate the effects of selumetinib treatment on the anti-viral     treatment HIV patients receive to control HIV infection. Phase II of this trial will     investigate how well selumetinib works as a treatment for KS at the best dose determined in     phase I.   "
117147|NCT01752556|"     Primary objectives:      The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against     polysomnography (PSG) using the Epworth scale;      Secondary Objective:        1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth          Scale and EuroQol 5D.        2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2)          adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry          determinations. Design: prospective, randomized, controlled, open, parallel of          non-inferiority. 440 patients will be randomized to diagnose and follow treatment based          on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical          analysis: We will compare the change in the Epworth scale between both arms of treatment          through analysis of covariance. The premise of non-inferiority is -2 at the lower limit          of 95% IC. Secondary variables will be analyzed using differences in independent means          (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness:          costs generated by one and another method will be evaluated against the effectiveness of          the primary variable using Bayesian techniques   "
117148|NCT01752543|"     The purpose of the present study is to evaluate the effects of a blockade of the vasopressin     system and central hemodynamic system in heart failure (HF) patients during physical     exercise. The significance of the vasopressin system during physical exercise is unclear. If     vasopressin is a significant regulator of exercise hemodynamics in HF, strategies to     intervene against activation of the V1A-receptor might be expected to improve HF symptoms and     possibly outcome.      The potential effects of the central hemodynamic system will be evaluated with a Swan-Ganz     catheter. Echocardiography will be performed at rest and during submaximal working capacity     before and during the infusion of a vasopressin receptor antagonist (conivaptan) or placebo.     Cardiac output will be measured by thermodilution. The exercise test will be performed at 50     % of VO2 max and hemodynamic and echocardiographic measurements will be collected. The     exercise test will be performed on a supine multistage bicycle.   "
117149|NCT01752530|"     The purpose of this study is to determine the effect of computer program C8 on specific     cognitive functions, symptoms and functional outcome compared to treatment as usual in     children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training.     In addition, it will be investigated, whether younger children benefit more from training     than older children.   "
117150|NCT01752517|"     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and     etoposide(CE)and second-line therapy with topotecan has been given, patients with ED-SCLC     still relapse and 2-year survival is less than 10%. There is no standard treatment     recommendation for this group of patients who failed to second-line therapy and had good     performance status. Some cytotoxic drugs for the treatment of non-small cell lung cancer,     i.e. vinorelbine, paclitaxel, and ifosfamide, were used in refractory or recurrent SCLC     patients. Recently, a retrospective study showed the overall response rate was 30%, the     median progression free survival (PFS) was 6.5 months, and the median overall survival was     10.4 months in advanced combined SCLC patients treated with first-line regimen of     vinorelbine, ifosfamide and cisplatin (NIP). Because of the previous platinum administration     and patient's performance status, only vinorelbine and ifosfamide (NI) are combined and used     as third-line therapy for refractor or recurrent ED-SCLC in our lung cancer center. And this     clinical trial is designed to prospectively investigate the efficacy and safety of NI regimen     in refractory or recurrent ED-SCLC patients in our center.   "
117151|NCT01752504|"     The proposed study seeks to continue the implementation of Connect to Protect® (C2P), a     community mobilization intervention, which entails developing coalitions to plan for and     bring about structural changes for purposes of reducing HIV incidence and prevalence among     youth in targeted communities at five ATN sites.   "
117154|NCT01752465|"     Antipsychotic medications frequently cause metabolic side-effects, such as abdominal obesity,     high blood pressure, cholesterol abnormalities, and blood sugar dysregulation, all of which     can lead to what is known as the Metabolic Syndrome and serious long-term cardiovascular     health problems. Therefore, it is important that metabolic issues be addressed as part of a     holistic approach to the mental health treatment of these patients.      As with the general population, improving metabolic health involves lifestyle changes - i.e.,     addressing daily habits regarding eating, physical exercise, stress and sleep management, and     lifestyle habits such as smoking. However, there is growing recognition in the medical field     that education is not enough for people to create meaningful and sustained lifestyle change.     The emerging field of Integrative Health Coaching addresses this issue and provides a     clinical framework for helping people successfully develop and achieve personalized lifestyle     goals. The investigators have therefore decided to investigate whether health coaching     techniques may have benefit in addressing metabolic health issues in people with psychosis     disorders. The intent is to complement usual psychiatric and medical care, and also promote     patient engagement in managing one's overall health.      This study will investigate whether Integrative Health Coaching is a useful clinical tool to     facilitate healthy lifestyle behaviour and thereby improve metabolic health in people with     psychosis disorders.   "
117155|NCT01752452|"     Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient     treated with external fixation.   "
117156|NCT01752439|"     The purpose of the study is to evaluate the efficacy of the transcranial direct current     stimulation of the primary motor cortex (M1) in patients affected by refractory chronic     migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and     medication-overuse headache (coded as 8.1) with migraine as primary headache.   "
117157|NCT01752426|"     The goal of this clinical research study is to learn how PCI-32765 (ibrutinib) may affect the     life cycle of blood-cancer cells. Cancer cells will be labeled with heavy water to learn     about their birth rates and death rates.      Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that     help cells live and grow. The study drug is designed to inhibit or block the activity of a     type of kinase that helps blood-cancer cells live and grow. By blocking the activity of this     specific kinase, it is possible that the study drug may kill the cancer cells or stop them     from growing.      Heavy water (2H2O) is a special type of water that is designed to help researchers learn how     quickly cancer cells in the body reproduce.   "
117158|NCT01752413|"     The purpose of this study is to determine (1) the role of ferritin testing to screen for iron     depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement     therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers     to routinely distribute oral iron replacement therapy to donors.   "
117159|NCT01752400|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the drug is being studied and that research doctors are trying     to find out more about it-such as the safest dose to use, the side effects it may cause and     if the drug is effective for treating your type of cancer. It also means that the FDA has not     yet approved the drug for your type of cancer or for any use outside of research studies.      It has been found that some people with NSCLC have a change (mutation) in a certain gene     called the ALK gene. This mutated gene helps cancer cells grow. There is a drug (crizotinib)     that has been approved by the FDA for the treatment of people with NSCLC who have mutations     in the ALK gene. Most people respond to crizotinib initially. Over time, however, patients     may stop responding (become resistant) to crizotinib because of additional changes in the ALK     gene that makes crizotinib ineffective.      AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This     drug has been used in other research studies. Information from those other research studies     suggests that AUY922 may be effective in killing cancer cells that have become resistant to     drugs like crizotinib. Only participants with changes in the ALK gene will be allowed to     participate in this study.      The purpose of this study is to test the safety of AUY922 and determine how well AUY922     treats participants with advanced, ALK-positive NSCLC.   "
117160|NCT01752387|"     The purpose of this study is to compare the surgical treatment for sportsman's hernia in our     department to the current literature. Our hypothesis is that combined solution for the two     major problems that cause pain in this syndrome - repair the weakness in the posterior wall     of the inguinal canal with tension free technique (mesh repair) and reducing the muscle     strain on the abdominal wall by cutting, partially, the tendon of the external oblique     muscle, will shorten the time to return to full physical activity in soccer players.   "
117161|NCT01752374|"     We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3     antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and     vomiting after laparoscpic abdominal surgery.      This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in the     prevention of PONV for laparoscopic surgery in patients receiving PCA IV.   "
117162|NCT01752361|"     The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering     from severe Ulcerative Colitis (UC) and to compare these results with similar results from a     study on healthy subjects.      Both studies are done with the use of Motilis 3D-Transit system which consists of a small     electronic capsule ingested and detected by a receiver carried by the patient. Position and     orientation of the capsule are interpreted by dedicated computer software and transit times,     progression velocity and contraction frequencies can be revealed.      The study is mainly descriptive and is designed to test and evaluate the usefulness of the     Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe     inflammation.      Motilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a     whole during severe illness.      We expect to include 20 patients suffering from severe UC admitted to Hospital with the     purpose of getting medical treatment. We do not expect any drop out, but in case of drop out     a new patient will be included.   "
118280|NCT01737762|"     This study is being done to find out if an investigational product called HP802-247 can help     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by     the U.S. Food and Drug Administration (FDA).      At least 250 subjects will participate. The study is going to be conducted in approximately     50 sites in the United States and Canada.   "
117167|NCT01752296|"     Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal     recessive genetic lysosomal storage disorder. Research thus far regarding lysosomal storage     diseases (LSDs) in general, including Morquio, has primarily focused on exploring the causes     of and finding a treatment for the physical aspects of the various diseases. Less attention     has been paid to the psychological or emotional toll of these diseases, whether they are     direct symptoms of the diseases themselves or reactions to living with a chronic progressive     disease.      It is well established in the health psychology literature, however, that the interaction     between our physical health and our psychological health is bidirectional; that is, just as     our physical health affects us emotionally (e.g. chronic pain can contribute to depression),     so can our psychological health affect us physically (e.g. anxiety can contribute to feelings     of chest pain). It is thus critically important to pay attention to the emotional and     psychological symptoms associated with all lysosomal storage diseases, including Morquio, and     expand our treatment standard of care to include mental health treatment, if necessary.      The first step in understanding and treating psychological conditions in Morquio disease is     determining the natural occurrence of psychological symptoms in this population in comparison     with non-medical populations. As little has been done in this regard, a pilot study     documenting the occurrence rate of psychological issues and overall quality of life in     patients with Morquio is the first item in order and will be the focus of this study.      Approximately 20 patients with Morquio disease will be invited to participate, recruited     through Emory's Lysosomal Storage Disease Center, as well as through attendance at Morquio     support groups and relevant regional, national and/or international meetings. Once consented,     patients will be asked to complete three different self-report questionnaires, including the     Achenbach System of Empirically Based Assessment (ASEBA) Adult Self-Report (ASR) or Older     Adult Self-Report (OASR) questionnaire, the Short Form 36-item Health Questionnaire (SF-36),     and the Brief Pain Inventory (BPI). Group aggregate data only will be reported; individual     questionnaire content and results will be held confidential, except as in accordance with     Georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent.     Completion of these questionnaires will complete subjects' participation in this pilot study.   "
117168|NCT01752283|"     The study is aimed to investigate the safety and feasibility of Video-assisted thyroidectomy     under hypnosis in comparison to general anesthesia   "
117169|NCT01752270|"     Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to     affect more than 5% of the population and is associated with chronically elevated serum     androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative     impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive     disease during pregnancy,and preterm birth,which is partially related with the     hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic     drug.At present, there is no direct evidence that Diane-35 has a positive effect on the     clinical outcome of polycystic ovary syndrome patients undergoing In-vitro     fertilization/Intracytoplasmic sperm injection.   "
117170|NCT01752257|"     The purpose of this pilot study is to determine the prevalence of markers of chronic and     cycling hypoxia and reactive species stress (oxidative and nitrosative) in the melanoma tumor     microenvironment. The study is based around four cornerstone features of the pathologic     microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1     and VEGF, which the investigators term the HRHV axis. Patients with in-transit melanoma (AJCC     Stage IIIB or IIIC) (1) will be administered the hypoxia marker drug, EF5, 24 hr prior to     isolated limb infusion (ILI) or hyperthermic isolated limb perfusion (HILP). Tumor biopsies     will be performed just prior to ILI or HILP, at the 30 minute time point during ILI (or 60     minute time point during HILP), AND 24 hours after ILI or HILP. Tissues obtained will be snap     frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of     immunohistochemical and urine markers that depict the HRHV axis will also be examined. The     association of the markers with the presence of hypoxia, as determined by EF5 positivity,     will be determined. Data from this pilot study will be used to establish the prevalence of     markers of the HRHV axis in melanoma. This information will be crucial for future human     trials in which the HRHV axis is therapeutically targeted.   "
117171|NCT01752244|"     Obesity-induced chronic inflammation is a key component of the pathogenesis of insulin     resistance. Mounting evidence has demonstrated anti-inflammatory characteristics for vitamin     D. Although analogues of vitamin D3 have extensively been used in the treatment of various     chronic inflammatory diseases, to our knowledge, no such research is conducted in regards     with obesity. The aim of this double blind clinical trial study is to investigate whether     alphacalcidol treatment in obese subjects can affect the insulin resistance. Moreover, we     will evaluate the pathways of Vitamin D receptor (VDR), Peroxisome proliferator-activated     receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α)     gene expressions which may lead to insulin resistance following treatment with either     alphacalcidol or placebo.   "
117172|NCT01752231|"     This pilot clinical trial studies dynamic contrast enhanced (DCE)-magnetic resonance imaging     (MRI) in diagnosing cancer. New diagnostic procedures, such as DCE-MRI may help find and     diagnose cancer   "
117173|NCT01752218|"     The purpose of this open, prospective study is to address the effectiveness and precision of     the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after     femtolaser-assisted cataract surgery.   "
117174|NCT01752205|"     The purpose of this study is to test the safety and effectiveness of erlotinib and     chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous     cancer .   "
117175|NCT01752192|"     The idea behind the Teledi@log consortium is to develop tele-rehabilitation concepts and     technologies so that all types of heart disease patients, regardless of degree of severity,     can be offered individual, customized and coordinated tele-rehabilitation across sectors. The     project is innovative, breaking new ground in relation to existing national and international     research projects in the area. The Teledi@log consortium sees its major task as developing     and testing scenarios which can lead to a more coherent rehabilitation for heart patients in     areas such as patient training, organization across the boundaries of the health system and     using tele-rehabilitation technology. The Teledi@log consortium seeks to develop new     tele-rehabilitation concepts which bring the patient closer to the health system and thereby     promote the heart patient's rehabilitation, giving the patient and their families a more     active role via new tele-rehabilitation technologies.The hypothesis of the study is that     heart patients participating in a telerehabilitation program will have a higher quality of     life compared to heart patients following traditional rehabilitation activities.   "
117177|NCT01752166|"     The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and     specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results     and/or known Candida positive status of prospectively collected and contrived (i.e.     Candida-spiked) clinical specimens.   "
117224|NCT01751542|"     Randomized clinical trial comparing standard residential substance abuse treatment to     standard residential treatment plus Mindfulness and Acceptance Group Therapy for substance     use.   "
117178|NCT01752153|"     A wide spectrum of immune abnormalities has been described by numerous studies involving     β-thalassemic patients with multiple transfusions. The abnormalities observed are both     quantitative and functional, and concern several components of the immune response.     Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert     multiple biological effects, including antioxidant and free radical scavenging abilities.     Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn),     have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as     hepatoprotective agents. Silymarin is already being used clinically for treatment of liver     diseases.It is considered safe and well-tolerated, with reported adverse events similar to     placebo. Several studies have also reported immunomodulatory actions of silymarin. It     increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10 secretions     by stimulated lymphocytes in a dose-dependent manner. It has been shown that in vitro     treatment of peripheral blood mononuclear cells with silymarin causes restoration of the     thiol status and increases in T cell proliferation and activation. Because reactive oxygen     species and iron overload play important roles in the pathophysiology of thalassemia,     silymarin may be an effective therapy due to its antioxidant, immunomodulatory,     cytoprotective and iron chelating activities. The present study designed to investigate the     therapeutic activity of orally administered silymarin for treatment of β-thalassemia major, a     well-known and prevalent disease in Iran, which is associated with oxidative stress, iron     overload and immune abnormalities.   "
117179|NCT01752140|"     In this study, the investigators aim to determine if the Vienna nomogram increases the     detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study     comparing the Vienna nomogram with a 10-core biopsy protocol.   "
117180|NCT01752127|"     The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott     Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these     are thought to be superior in effect and stability compared to ZES and EES of previous     generation, there are few clinical data regarding the high risk groups of diabetes patients     or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer     study (23% diabetes), the investigators could not know the outcome in high risk patients such     as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the     effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels     lesion patients.   "
117181|NCT01752114|"     This study is intended to determine the positive predictive value (PPV) and negative     predictive value (NPV) of the multiprotein classifier based on the observed study prevalence     of Non-Small Cell Lung Cancer (NSCLC) in the study participants.   "
117182|NCT01752101|"     The primary objective is to identify a panel of plasma and/or serum proteins that     differentiates the absence or presence of lung malignancy in samples obtained from subjects     enrolled in this IRB/EC approved study with pulmonary nodules.   "
117183|NCT01752088|"     This study is to evaluate the magnetic resonance imaging (MRI) and clinical results of     arthroscopic repair of subscapularis tears   "
117184|NCT01752075|"     The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients     treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a     real-world setting (versus a clinical trial).   "
117185|NCT01752062|"     The objective of this study is to acquire more information about what we are doing during     pregnancy in CML patients, in order to possibly establish in the future a consensus on the     management of patients receiving TKIs who wants to father a child or become/are pregnant.   "
117186|NCT01752049|"     Hereditary hemorrhagic telangiectasia (HHT) is a hereditary vascular condition characterized     by the development of abnormal connections between arteries and veins throughout the body,     called vascular malformations. These abnormal blood vessels are referred to as arteriovenous     malformations (AVM) if they are large and telangiectasias if they are small. Telangiectasias     develop due to irregular growth of blood vessels.      Anti-angiogenic therapy, such as the drug Apo-Timop, curbs the growth of new blood vessels.     Apo-Timop is included in a class of medications called beta-blockers. Anti-angiogenic     therapies exert their beneficial effects in a number of ways: by disabling the agents that     activate and promote cell growth, or by directly blocking the growing blood vessel cells.      The investigators think that anti-angiogenic therapy may lead to the shrinking of     telangiectasia in people with HHT. The investigators hope that this study will provide us     with proof of this concept and might lead to the development and study of anti-angiogenic     therapies to help improve the lives of individuals with vascular malformations.   "
117187|NCT01752036|"     Although it is being increasingly used off protocol, there is minimal data regarding the     efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of     metastatic lesions to the spine. The primary objective of this study is to evaluate     radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared     to the expected rate following conventional radiation therapy.   "
117188|NCT01752023|"     Response rates.      Changes in tumor blood flow.   "
117190|NCT01751997|"     This study will compare the clinical outcomes of transplants from     family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated     donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings        1. Primary objectives: Overall survival of FMT may be similar to that of MUT        2. Secondary objectives:           i. Comparison of disease-free survival, relapse, non-relapse mortality, immune          reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease          between FMT and MUT.           ii. Investigation of possible biomarkers related with above events after transplantation   "
117191|NCT01751984|"     This study will assess the LDL-C lowering efficacy and safety of ETC-1002 versus placebo in     subjects with hypercholesterolemia and a history of statin intolerance.   "
117192|NCT01751971|"     This study seeks to employ advanced methods to estimate the individual factors contributing     to sleep apnea from standard recordings made during routine clinical sleep studies. This     study focuses on breathing control or loop gain as one of the factors contributing to sleep     apnea. Increased levels of oxygen in the air is known to make breathing more stable by     lowering loop gain. Here, our goal is to use a new method capable of detecting a reduction     in loop gain with oxygen. The investigators also aim to test whether a high loop gain     measured at baseline/placebo predicts a greater improvement in sleep apnea with oxygen     therapy.   "
117196|NCT01751919|"     1. Investigational Product             1. Imatinib mesylate tablet 400 mg             2. Glivec film-coated tablet 100 mg (Comparator)        2. Expected target disease             1. chronic myeloid leukemia             2. Gastrointestinal stromal tumors        3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study             1. 36 healthy subjects, 2 groups (18 subjects/group)             2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))             3. wash-out period : 14 days        4. Evaluation on pharmacokinetics(PKs) and safety             1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2             2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test        5. Statistical method             1. Demography Characteristics             2. Pharmacokinetic parameters             3. Safety data   "
117197|NCT01751906|"     The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the     pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular     Scaffold (BVS).      The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study     and ABSORB IV RCT trial which are maintained under one protocol because both trial designs     are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and     ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will     evaluate the safety and effectiveness of Absorb BVS.   "
117198|NCT01751893|"     The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly     occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants     special attention because it is the most common dose-limiting toxicity. this study is     designed to test the effectiveness of a henna treatment protocol in the management of     capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar     erythrodysesthesia.   "
117199|NCT01751880|"     Gastric cancer is a major health issue and one of the most common malignance in Korea. With     the popularization of cancer screenings and increasing the average lifespan, the number of     gastric cancer patients is increased. In the past, most of the research were concerned with     survival and recovery after cancer surgery. However, as the medical technology had been     developed and recovery rate and survival rate of cancer patients had risen, the patients     wanted to return to a daily life and desire for participation for leisure. In other words,     the patients who underwent surgery wants to maintain a high quality of life(QOL) level as     like prior to cancer surgery.      There are many reports on the effect of the exercise program after cancer surgery. In     addition, exercise program was associated with improving the QOL and functional recovery,     decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.      However, the subject patients of previous studies were Western people. Therefore, The results     were not disclosed whether the exercise program suited to the body characteristics of Korean     people. Furthermore there was no exercise program studies for the gastric cancer patients.      Medical service for cancer patients care should include not only diagnosis, treatment as like     surgery but efforts on enhancing the quality of life. In other words, post-management     education and management program as like exercise program are necessary for the cancer     patients after surgery. So, the research about how to practice the exercise program and how     to evaluate the effect on the recovery is needed.   "
117200|NCT01751867|"     The purpose of this study is to evaluate the effectiveness and safety of decitabine in the     treatment of myelodysplastic syndrome (name of a group of conditions that occur when the     blood-forming cells in the bone marrow are damaged) in Chinese patients.   "
117209|NCT01751750|"     The objectives of this study are the following: 1) to confirm that the administration of     grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and     urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined     administration of grape juice, resveratrol, and grape seed polyphenol extract result in a     similar plasma and urinary metabolic profile in adults with tendencies toward metabolic     syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory     effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol     extract.   "
117210|NCT01751737|"     This research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for     prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI     guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.   "
131862|NCT01559038|"     The current study will assess the real - life effectiveness of adalimumab in the management     of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis     (PsA).   "
117201|NCT01751854|"     The information derived from this study will be critical to establishing appropriate     rehabilitative interventions post-stroke. In particular, traditional use of pharmacological     agents to alter motor function post-stroke is directed primarily at reducing the positive     signs following upper motor neuron lesion, in particular spasticity, or enhanced,     velocity-dependent stretch reflex responses to imposed stretch. While pharmacological     management of spasticity certainly suppresses clinical and quantitative measures of     hypertonia, there is little improvement in functional performance. In contrast, preliminary     data on the administration of 5HT agents following neurological injury indicates an increase     in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic     motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to     maximize function following stroke despite potential, short-term increases in spastic motor     activity may improve therapeutic intervention strategies. The general objective of this study     is therefore to:        1. quantify the effects of short-term SSRI administration on voluntary and spastic motor          behaviors in individuals with chronic spastic hemiparesis,        2. identify the changes in impairments and functional recovery of walking ability during          BWSTT with the presence or absence of SSRIs.   "
117202|NCT01751841|"     Prospective/Retrospective data analysis, chart reviews and clinical outcomes of minimally     invasive spine surgery   "
117225|NCT01751529|"     This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced     ultrasound when used to evaluate renal lesions in two different populations; patients with     known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom     their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort     2).   "
117226|NCT01751516|"     This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal     cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and     after surgery.   "
117203|NCT01751828|"     The long-term goal is to determine if decreased blood flow to the brain (cerebral     hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD).     Studies in younger adult report that successful antidepressant treatment is associated with     increases in cerebral blood flow, with no change in blood flow being observed in     nonresponders. Thus cerebral hypoperfusion may be a biomarker of poor response to     antidepressants. In LLD, this may occur secondarily to underlying vascular disease. If LLD is     characterized by cerebral hypoperfusion and it does have predictive power to identify     individuals who will poorly respond to conventional antidepressants, this would support the     study of interventions that improve cerebral perfusion and may improve antidepressant     outcomes.      As an initial step in this research, this pilot study will utilize MRI to examine if resting     blood flow deficits predict and persist with antidepressant nonremission in an elderly     population. The rationale for this proposal is that it will guide the design and power     requirements of a larger, definitive trial examining the relationship between cerebral     perfusion and depression outcomes. Importantly, support for this mechanism being linked to     LLD would also support studies examining the antidepressant efficacy of drugs that may     improve cerebral perfusion.      The primary purpose of this pilot study is a) to demonstrate feasibility by recruiting,     scanning, and treating depressed elders; and b) to acquire preliminary data for competitive     grant submissions.      SPECIFIC AIM: To use MRI to test for differences in cerebral perfusion between individuals     who do and do not remit to a 8-week course of sertraline.   "
117204|NCT01751815|"     Background:      Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric     Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used     successfully to treat pain of various origins, but few good-quality studies have evaluated     its role in treating pain and anxiety during colonoscopy.      Objective:      To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the     consumption of sedatives/analgesics during colonoscopy.      Design:      Prospective, randomized, placebo-controlled study.      Subjects:      One hundred and twenty eight consecutive patients undergoing first-time elective day-case     colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.      Interventions:      Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before     colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension,     including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS     group, a non-conductive plastic film will be placed between the acupoint and the electrode so     that no current will be transmitted. Acu-TENS and placebo-TENS will be continued throughout     colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe     pump, will be used for sedation/analgesia in both groups.      Outcome measures:      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes:     pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time,     and episodes of hypotension/desaturation.   "
117205|NCT01751802|"     The purpose of this research study is to gather scientific information about the     effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of     self-injurious behaviors when compared with the effectiveness and safety of placebo (inactive     substance) in subjects with Lesch-Nyhan Disease.   "
117206|NCT01751789|"     The purpose of this study is to determine whether, for individuals in inpatient opioid     detoxification, linking to outpatient Suboxone treatment increases treatment adherence and     reduces relapse to illicit opioid use.   "
117207|NCT01751776|"     To evaluate the safety and tolerability of multiple doses of BI 655064 administered     subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To     explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI     655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess clinical     effect of BI 655064 in RA patients with prior inadequate response to methotrexate (MTX) after     12 weeks of treatment   "
117208|NCT01751763|"     Radical hepatic resection represents one of the treatment options offering a prospect for     cure with 5-year survival rates up to 50%. However, unintentionally, quite a proportion of     these radical resection actually turned out to be non-radical in nature. For these patients     who actually received non-radical resection, their by year survival rates were much lower     than those who received radical hepatectomy. In this prospective, non-interventional,     multi-center study, we are planning to observe the patient characteristics of Hepatocellular     carcinoma (HCC) patients who have residual disease after resection with curative intent, as     well as treatment pattern, safety and effectiveness of sorafenib for these patients.   "
117261|NCT01751061|"     Deciding about prolonged life support for critically ill patients can be very difficult.     Therefore, the investigators are doing a study to see if an internet-based decision aid can     improve the quality of decision making for substitute decision makers of patients who are in     the intensive care unit (ICU).   "
117211|NCT01751724|"     Most premature infants require mechanical ventilation for prolonged periods of time and a     significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a     stimulant of the respiratory center and has been used for the treatment of Apnea of     Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from     mechanical ventilation by starting therapy shortly before extubation. Recently the use of     Caffeine in ventilated infants has been initiated earlier because of the reported reduction     in BPD. However there is paucity of data supporting this practice.      Because protracted mechanical ventilation and supplemental oxygen increase the risk of     developing BPD, a therapy that would facilitate the reduction of the respiratory support and     shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of     early Caffeine initiation and administration during the course of mechanical ventilation in     preterm infants by means of a randomized placebo-controlled trial.      Hypothesis:      The primary hypothesis of this study is that early use of caffeine in mechanically ventilated     preterm infants will reduce the time to first elective extubation and secondarily, that this     will reduce the total duration of mechanical ventilation and oxygen supplementation, and     reduce the incidence and severity of BPD.      Objective:      The objective of this trial is to evaluate the effects of early caffeine use during     mechanical ventilation on the time to first elective extubation, total duration of mechanical     ventilation and oxygen supplementation, and the incidence of BPD.      Study Design:      This will be a single-center prospective, randomized, double-blind, placebo controlled     clinical trial.      Population:      Premature neonates born between 23 and 30 completed weeks of gestation, who require     mechanical ventilation within the first 5 days of life will be enrolled. Infants with major     congenital anomalies or small for gestational age will be excluded.      Methods:      Infants will be randomized within the first 5 days to receive a study drug consisting of     either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline).     Infants will continue to receive the study drug until the first elective extubation.   "
117253|NCT01751165|"     The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals'     HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged     50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer     than two months is not known.   "
117212|NCT01751698|"     Adaptive Interventions for Minimally Verbal Children with ASD in the Community, seeks support     to construct an adaptive intervention that utilizes two efficacious interventions (JASP-EMT     and CORE- DTT) that have shown promise for optimizing the number of unique socially     communicative and spontaneously spoken words in minimally verbal children with ASD. The study     utilizes a novel sequential multiple assignment-randomized trial to evaluate and construct an     optimal adaptive intervention. A total of 192 minimally verbal school aged children with an     Autism Spectrum Disorder (aged 5 to 8 years of age) will participate across four sites,     University of California Los Angeles, University of Rochester, Vanderbilt University and     Weill Cornell Medical Center with methodological and statistical support from University of     Michigan.   "
117213|NCT01751685|"     We propose to conduct a randomized, controlled trial among 100 men and women aged 60 or older     with hyperkyphosis to an exercise intervention that includes kyphosis-specific spinal muscle     strengthening exercises compared to a usual care control group. The study will be conducted     in five waves,with 10 participants in the exercise intervention and 10 participants in the     control group in each wave.   "
117214|NCT01751672|"     The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention     and Referral to Treatment (SBIRT) protocol with computerized screening technology into three     primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to     determine if an expanded SBIRT (SBIRT+) will help patients attend more specialty substance     abuse treatment sessions and reduce substance use compared to SBIRT; 3) conduct a process     evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and     structured interviews to assess implementation barriers and workforce attitudinal shifts; and     4) provide an excellent clinical research training environment for undergraduate and graduate     students from Lincoln University.   "
117215|NCT01751659|"     This is a three phase study designed to examine clinician behaviors with regard to     recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human     Immunodeficiency Virus (HIV) prevention strategy, and to identify knowledge-related and     attitudinal factors associated with these behaviors. Each phase consists of the following:      Phase 1: Semi-structured face-to-face or telephone interviews of ATN-affiliated clinicians.     Approximately 10 clinicians will be interviewed.      Phase 2: Development of a new theory-based survey instrument and cognitive interview testing     of this survey. Approximately five clinicians (of those who participated in Phase 1) will be     interviewed.      Phase 3: Administration of the newly developed survey to ATN-affiliated clinicians.     Approximately 60 clinicians will be interviewed.   "
117216|NCT01751646|"     This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of     adolescents and young adults with HIV infection in the ATN who are currently being treated     with cART that includes TDF as one component of the regimen that includes at least three Food     and Drug Administration (FDA)-approved ARVs for at least 180 days.   "
117217|NCT01751633|"     Thoracolumbar fractures are the most common spinal fractures with an average annual incidence     between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3     (burst fractures). Although patients with burst fractures report a reduced quality of life     and chronic pain, there is no clear evidence whether surgical or conservative treatment offer     better functional and back-pain related outcomes. The indications for the selection of an     ideal treatment for these fractures without neurological deficits remain controversial. The     purpose of this study is to evaluate whether patients with thoracolumbar fractures without     neurological deficit being surgically treated show faster recovery and better improvement of     function than patients being conservatively treated.   "
117218|NCT01751620|"     The proposed study is a two-group randomized repeated measures design that will examine the     efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting     Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU     sites across the United States. Youth will be randomized into one of two study arms; Project     ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison     condition. Both arms consist of two individual sessions followed by six group sessions and a     final individual session which is expected to take approximately nine weeks after which youth     will have four follow-up visits at the following time points:        -  post intervention (immediately after the last session);        -  3 months post the last session;        -  6 months post the last session; and        -  12 months post the last session. The trial will be repeated in up to three waves.   "
117219|NCT01751607|"     This prospective study aims to examine the association of specific genetic variants (single     nucleotide polymorphisms) located on chromosome 1, 4 and 16, with presence of non-pulmonary     vein triggers (NPVT) as well as ablation-outcome in AF patients   "
117220|NCT01751594|"     The proposed research study aims to conduct a culturally-based secondary prevention     intervention targeted toward HIV-positive Black young men who have sex with men (B-YMSM) to     explore (1) feasibility and acceptability (Trial 1 and Trial 2) and (2) evidence of potential     efficacy (Trial 2). The primary outcomes will be health promotion behaviors (i.e., treatment     adherence, sexual risk reduction, reduction in substance use behaviors, and HIV status     disclosure). Psychosocial factors (i.e. self-esteem, critical consciousness, and     socio-political awareness) will be examined as secondary outcomes.   "
117221|NCT01751581|"     Each 4-day period will follow the same protocol. Basically, for the entire study, we will     prepare all of the subject's food and will require him or her to eat all of the food that we     give at the times we tell them to eat. The subject will arrive at the hospital on the evening     of day 1, and become inpatients. On day 2, the subject will be permitted to leave the     hospital campus under the supervision of the research staff. On day 3, they will be required     to stay in a small room called a metabolic chamber for 24 hours. This room measures how many     calories you burn in one day. On day 4, we will measure the subject's energy expenditure in     response to a breakfast meal. They will be given breakfast and the number of calories that     they burn after that meal will be measured over a 6-hour period. Then the subject will be     discharged at the end of the test. The 2 study periods will differ only in bedtimes and     wakeup times. During one period, the subject will go to bed at 1 am and wake up at 5 am and     during the other period they will go to bed at 11 pm and wake up at 7 am.   "
117254|NCT01751152|"     This trial is conducted in Europe and the United States of America (USA). The aim of the     trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active     Crohn's disease.   "
117227|NCT01751503|"     Foot drop deformity is a life limiting condition characterized by loss of ankle dorsiflexion     and eversion. Main condition leading to drop foot condition include irrecoverable muscle and     nerve injuries, poliomyelitis, drug poisoning, strokes, cerebral palsy, Charcot - Marie -     Tooth disease, meningomyelocele, club foot, Friedreich's ataxia and Leprosy (1-4).      Anterior transposition of Posterior tibialis tendon (PTT) is the gold standard for surgical     restoration of functional dorsiflexion of a permanently paralyzed foot (1, 4-10). Two methods     of rerouting the posterior tibialis tendon have been reported, one through the interosseous     membrane i.e. Interosseous route (7, 10) and second subcutaneously around the medial side of     tibia i.e. Extramembranous or circumtibial route (11-13). Both these techniques have been     widely described in literature (4-16) and are being extensively used in surgical management     of foot drop. The selection of technique depends on surgeon choice and patient factors.      There is a clinical equipoise with regards to these two techniques of Tibialis posterior     tendon transfer and through our study we aim to compare the clinical and functional outcomes     of these two techniques. There are no studies in literature which compare the clinical and     functional outcomes with regards to both these methods. Although there are many studies to     demonstrate the functional and clinical effectiveness of the respective procedures, there is     a paucity of clinical trials comparing these two surgical techniques with regards to clinical     and functional outcomes. Furthermore there are no head to head clinical trials to compare the     outcomes with regards to these two methods of Tibialis Posterior tendon transfer (Medline     search dated 03/03/ 2012)      we propose to compare the clinical and functional outcomes with regards to the two techniques     i.e extra membranous and Interosseous technique of Tibialis Posterior tendon transfer     performed in patients with foot drop as a result of nerve palsy.      Through our prospective randomized trial we aim to answer the research question, whether one     method has any superior outcome over the other?   "
117228|NCT01751490|"     We will conduct a randomised clinical trial with the primary aim of determining whether     surgical intervention followed by physiotherapy rehabilitation improves pain and disability     outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic     shoulder instability associated with bony/capsulolabral damage. The results of this study     will have direct and immediate impact on clinical decision making by establishing     definitively if patients presenting with joint damage associated with atraumatic shoulder     instability should be referred for surgery before commencing physiotherapy rehabilitation.     The results of this study may also result in significant cost savings to the National Health     Service if surgical intervention for atraumatic shoulder instability does not result in     greater improvement than physiotherapy alone.   "
117229|NCT01751477|"     Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies     in preterm neonates and a leading cause of death and morbidity.      The pathogenesis of NEC remains largely unclear, but it is widely considered as a     multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and     intestinal ischemia have been proposed as major risk factors.      Probiotics may prevent NEC by improving the maturity and function of the gut mucosal barrier,     modulating the immune system, promoting colonization of the gut with beneficial organisms and     preventing colonization by pathogens.      A variety of clinical trials have evaluated the effect of different probiotic preparations on     the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a     benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of     practice.      The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in     reducing the incidence of NEC after implementation in clinical routine in preterm (< 34 weeks     gestational age) very low birth weight infants compared to a historical cohort.   "
117230|NCT01751464|"     This is a feasibility study of a WrapAround Case Management Program for Youth Injured by     Violence. Youth (aged 10-24) who have been injured by violence and visit the emergency     department will be offered a support worker who will provide WrapAround Case Management. This     study is designed to assess the feasibility of recruitment, enrollment and follow-up.   "
117273|NCT01750905|"     The most promising chimeric natriuretic peptide designed and studied by our group has been     CD-NP which has anti-fibrotic and cardioprotective properties in vivo, vitro and in normal     volunteers and human heart failure patients. Since left ventricular assist device (LVAD) can     not reverse remodeling of the heart whereas it can improve hemodynamics, CD-NP may be novel     anti-fibrotic and anti-remodeling drug as co-therapy during LVAD support.   "
117274|NCT01750892|"     This study is looking at ways to help young people with chronic health conditions take better     care of their health and find an adult doctor.   "
117231|NCT01751451|"     In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug     abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients     with metastatic castration-resistant prostate cancer who have received prior docetaxel     (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to     treat patients with metastatic castration-resistant prostate cancer who have not received     prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly     injection, is FDA approved for the treatment of patients with advanced prostate cancer. The     purpose of this study is to evaluate abiraterone acetate and prednisone in combination with     degarelix as a possible treatment for PSA recurrent prostate cancer as compared to     abiraterone acetate alone and degarelix alone. This will be the first time these drugs will     be used together.   "
117232|NCT01751438|"     The goal of this clinical research study is to learn if treatment with standard systemic     therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery     or radiation therapy is more effective at controlling prostate cancer than standard systemic     therapy alone. The safety of this treatment combination will also be studied.   "
117233|NCT01751425|"     This is a 2 part study. The goal of the first part of this clinical research study is to find     the highest tolerable dose of ruxolitinib that can be given with a TKI that you are already     taking (such as gleevec, sprycel, or nilotinib) as part of your standard of care treatment.     The goal of the second part of this study is to learn if this drug combination can help to     control CML. Although you have a good response to therapy, the disease is still detectable at     low levels (this is called minimal residual disease). Researchers believe that eliminating     all detectable evidence of disease may decrease the chances that the leukemia will ever come     back. The safety of the drug combination will also be studied in both parts.      Ruxolitinib is designed to block a protein called Jak2 that may help keep some leukemia cells     alive even with TKI therapy. Blocking this protein may cause the cells to die.   "
117255|NCT01751139|"     The purpose of this study is to estimate the incidence of dengue infection in children and     adults in geographically distinct locations of Brazil.   "
117256|NCT01751126|"     The objective of this study is to compare the efficacy of two different dosing regimen of     NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of     the formulation) administered four times a day in patients with severe vernal     keratoconjunctivitis after 4 months of treatment.   "
117234|NCT01751412|"     This research study is a Pilot Study. Pilot studies are conducted to see if it is practical     to do this type of research on a larger scale in the future. The pilot part of this study is     to assess the possibility of using proton radiation to treat lymphomas. Proton radiation is     used for many other types of malignancies, but its use for the treatment of lymphoma has been     limited. The treatment is still being studied as research doctors are trying to find out more     about its use in the treatment of different types of lymphoma. Proton beam radiation therapy     is an FDA approved radiation delivery system.      Patients are being asked to participate in this research study if they have lymphoma in the     center of their chest, near their heart. Conventional radiation therapy with photons is used     as standard treatment for many patients with lymphoma. In this research study investigators     are looking at another type of radiation called proton radiation, which is known to spare     surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area     requiring radiation but delivers no dose beyond the region requiring treatment. This may     reduce side effects that patients would normally experience with conventional radiation     therapy or other means of delivering proton radiation therapy.      In this research study, investigators are evaluating the effectiveness of using proton     radiation delivered to reduce side effects associated with radiation treatment.   "
117235|NCT01751399|"     The primary purpose of this study is to help answer the following research questions:        -  To evaluate how much of the study drug (LY2605541) is in the blood of participants with          varying degrees of liver impairment compared to those with normal liver function        -  To assess the safety of LY2605541 and any side effects that might be associated with it   "
117236|NCT01751386|"     Background:      - Baclofen is a drug used to control muscle stiffness in people with neurological diseases.     Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce     anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if     baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels.      Objectives:      - To see if baclofen is safe and helpful for people who have alcoholism and high anxiety     levels.      Eligibility:        -  Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and          anxiety issues.        -  Participants must not be taking anti-anxiety medication.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Tests of alcohol dependency and anxiety levels will also be          given.        -  Participants will be divided into two groups. One group will take baclofen. The other          group will have a placebo.        -  About 1 week after the screening visit, participants will have a study visit. They will          answer questions about their behavior and mood. They will then start to take either          baclofen or a placebo. Participants will take the study drug three times a day, every          day.        -  After 1 week on the study drug, participants will have an overnight stay at the National          Institutes of Health. They will have blood tests and answer questions about mood and          behavior. They will also have tests that involve choosing to drink alcohol and answering          more questions about cravings.        -  Participants will stop taking their study drug over a 3-day period.        -  A final follow-up visit will be required 1 week after the overnight study visit.          Participants will receive information about other alcohol abuse treatment programs.   "
117237|NCT01751373|"     Within the first year after stroke, approximately 38% of stroke survivors experience an     increased resistance to movement, also called spasticity. One type of treatment that is     approved for stroke survivors in Canada that could reduce spasticity is the injection of     Botulinum toxin (BTX) into the affected muscle. While BTX reduces spasticity, there is     limited evidence to show that BTX administration leads to functional improvements. This may     occur because the outcomes aren't sensitive enough to detect change, some people may have     better responses to BTX, or because BTX hasn't been paired with the right exercises to     improve function. The aims of this research are: i) to determine if there is a way of     improving the markers that measure change in response to treatment; and ii) to identify the     ideal type of exercise that should be paired with BTX to allow the drug to have it greatest     effect.      There are two primary research questions: a) What are the measures that will indicate whether     a person with post-stroke spasticity will benefit from BTX therapy? It is hypothesized that     EMG latency and amplitude, for those who best respond to BTX, will differ from those who     demonstrate a weaker response to BTX; b)What is the ideal training approach for improving     muscle function in stroke survivors receiving BTX injections? It is hypothesized that a     training protocol that focuses on optimizing specific muscle activation patterns will     demonstrate better outcomes than a training program designed to improve function.   "
117238|NCT01751360|"     To evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.   "
117288|NCT01750710|"     This exploratory cross-sectional study proposes, firstly, to objectify in a population of     Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording     of electrical parameters and upper limb muscle strength of the thigh and in a second step, to     seek a relationship between the measured parameters.   "
117239|NCT01751347|"     The use of local anesthetics has become an important aspect of pain management in surgical     settings and is currently recommended in pain management guidelines.      Elective outpatient hand surgeries, such as carpal tunnel or trigger finger release, cause     minimum tissue disruption and are short in duration. As a result, these local anesthetic     agents are a major component in post-operative pain control. The most commonly used local     anesthetic agents are Lidocaine and Bupivacaine. Lidocaine acts faster (within 2-5 minutes of     injection) and for this reason is often favored in outpatient setting for pre-incisional     injection. However its effects only last up to 2 hours, without epinephrine, and 3 hours,     with epinephrine. On the other hand, Bupivacaine, has a slower onset of action (about 5-10     minutes after injection) but its effects last much longer, for about 4-8 hours. The delay in     onset of action makes it a less popular option as a primary source of local anesthesia in     outpatient hand surgery.      Given the longer duration of anesthesia offered by Bupivacaine, the investigators believe     that by giving it pre-operatively in elective outpatient hand surgeries will offer more     effective post operative pain control compared to using Lidocaine only. There is limited     published data confirming the effectiveness of use of pre-operative Bupivicaine in improved     postoperative pain control and decreased consumption of narcotics. Therefore, the aim in this     study is to compare the postoperative pain experienced by patients undergoing either elective     carpal tunnel release or trigger finger release as well as their use of pain medications when     the incision site is infiltrated preemptively with Lidocaine versus Bupivacaine.      The investigators believe that adequate post surgical pain control is essential for patients'     full functional recovery. Poorly controlled post surgical pain increases incidence of surgery     related complications and thus increased health care costs. It can also reduce patients'     mobility, delay their return to full function,. If poorly controlled, post surgical pain may     progress to chronic pain and rarely complex regional pain syndromes may ensue.   "
117240|NCT01751334|"     The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its     variability was investigated in this study in order to determine whether a certain landmark     could be employed as a reference axis for the proximal tibia after rotating platform mobile     bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).   "
117241|NCT01751321|"     Glucose Variability With DPP-4 Inhibition   "
117265|NCT01751009|"     This study tried to prove that children given food supplements containing vitamin A would     have better liver vitamin A stores than children given food supplements without vitamin A     over a 5 month period.   "
117266|NCT01750996|"     The goal of the Strongest Families Finland Canada project is to help parents develop skills     to strengthen their families and reduce disruptive behavior in their 4 year old children.   "
117242|NCT01751308|"     Primary Objectives:      Phase 1 Part:      To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of     cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid     tumors including tumors of the central nervous system.      Phase 2 Part:      To determine the objective response rate (complete and partial response) and the duration of     response to cabazitaxel as a single agent in participants with recurrent or refractory high     grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).      Secondary Objectives:      Phase 1 Part:      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or     refractory solid tumors including tumors of the central nervous system.      To characterize the pharmacokinetic (PK) profile of cabazitaxel in participants with     recurrent or refractory solid tumors including tumors of the central nervous system.      To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in     participants with recurrent or refractory solid tumors including tumors of the central     nervous system.      Phase 2 Part:      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or     refractory HGG or DIPG.      To estimate progression free survival in participants with recurrent or refractory HGG or     DIPG.      To estimate overall survival in participants with recurrent or refractory HGG or DIPG.      To characterize the plasma PK profile of cabazitaxel in participants with recurrent or     refractory HGG or DIPG.   "
117243|NCT01751295|"     The purpose of this study is to evaluate the effect of statin on the coronary     microcirculation dysfunction measured after percutaneous coronary intervention.   "
117244|NCT01751282|"     The purpose of this study is to determine the effectiveness of Autologous Bone Marrow-Derived     Mesenchymal Stem Cells (MSCs) in the treatment of non-healing wounds.   "
117245|NCT01751269|"     RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem     to treat bacterial infections, including those due to multi-drug resistant bacteria.   "
117246|NCT01751256|"     The purpose of this study is to determine wether wound infiltration brings additional     analgesia effect after cesarean section with optimal standard postoperative analgesia   "
117247|NCT01751243|"     Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre,     prospective, of cohort of patients who will receive different doses of allo-depleted     lymphocytes .      This project joins in this pioneering worldwide initiative with its own technology based on     the use of proteasome inhibitors in vitro, which advantages are, over other methods     described, the continuing viability of regulatory T cells and the use of a product to     generate allo-depletion that, contrary to those reported by other research groups, it does     not pose problems from the point of view of its use or toxicity as we employ a drug widely     used clinically by intravenous administration.   "
117248|NCT01751230|"     The purpose of this study is to help women lose the weight they gained during their pregnancy     using a SmartPhone app the investigators have developed called E-Moms. The investigators     hypothesize that the moms given the app to use during the study will lose more weight than     the moms who do not use the app.   "
117249|NCT01751217|"     The current proposal is a randomized clinical trial testing the efficacy of Functional Family     Therapy (FFT) administered by video teleconference (FFT-V) in the homes of substance abusing     adolescents. In the proposed investigation, FFT-V will be compared with FFT administered     face-to-face in the family home as well as to a services-as-usual (SAU) condition. The     overarching objective of the study is to examine the degree to which an empirically based     model of substance abuse treatment such as FFT can be effectively administered via video     teleconferencing to adolescents and families living in rural and remote areas who would be     otherwise unlikely to access treatment. The specific aims of the proposed study are to (1)     evaluate the efficacy of FFT-V compared to FFT and SAU in reducing adolescent drug use, HIV     risk behavior, delinquency, and recidivism, (2) evaluate the efficacy of FFT-V compared to     FFT in establishing functional levels of therapeutic alliance formation, treatment     attendance, retention, and satisfaction with treatment, (3) evaluate the efficacy of FFT-V     compared to FFT and SAU in impacting core mechanisms of change in adolescent behavior     including improved levels of family functioning and adolescent association with substance     using peers, and (4) conduct a preliminary cost-effectiveness analysis to derive initial     estimates of the relative costs of each treatment modality per outcome unit.   "
117250|NCT01751204|"     The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion     water.   "
117289|NCT01750697|"     This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the     safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with     severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants     will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1,     8, 15 and 22.   "
117251|NCT01751191|"     Background: In patients with cirrhosis on secondary prevention of variceal rebleeding with     non-selective beta-blockers (NSBBs), the risk of rebleeding and death is markedly higher in     those failing to achieve a good hemodynamic response (HVPG reduction ≥20% of baseline values     or ≤12mmHg). However a substantial proportion of non-responders will never rebleed, thus     appearing protected by NSBBs although non-detected by HVPG response. This low sensitivity     hampers risk stratification and diminishes the cost-effectiveness of assessing the     hemodynamic response to NSBBs. This is particularly relevant in prevention of rebleeding     since in this scenario the risk of rebleeding and of other portal hypertension related     complications is very high, which calls for early institution of effective therapy.      Baseline HVPG bears prognostic significance with regards to risk of developing varices,     decompensation, hepatocellular carcinoma and death1,2,7,8,18-27. However, no studies have     investigated whether adding data from baseline HVPG may improve the sensitivity of the     criteria defining a good or poor hemodynamic response.      Hypothesis: Adding data from baseline HVPG may improve the sensitivity of the criteria     defining a good or poor hemodynamic response.      Objective: Exploring the prognostic value of basal HVPG that better discriminate those     non-responders who do not re-bleed under prophylactic treatment with NSBBs.      Methods: Observational cohort study. Training set: patients from two longitudinal studies     conducted at the Hepatic Hemodynamic laboratory of the Hospital Clínic of Barcelona to assess     the prognostic value of HVPG changes during continuous therapy with NSBBs for preventing     variceal rebleeding. Validation set for chronic hemodynamic response: patients from two     longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the Hospital de Sant     Pau of Barcelona to assess the prognostic value of HVPG changes during continuous therapy     with NSBBs for preventing variceal rebleeding; a third cohort composed of patients undergoing     acute hemodynamic response to intravenous propranolol will be studied.      All patients received a preplanned follow-up in the outpatient clinic at 1, 3, and 6 months,     and every 6 months thereafter in the original studies.      End-point: bleeding from portal hypertensive sources (esophago-gastric varices or portal     hypertensive gastropathy) (defined according to Baveno criteria 32), death or liver     transplantation.      Ethical aspects: All patients have given their written informed consent to use their data in     the original studies.   "
117252|NCT01751178|"     The aim of this study is to compare subject gingival health after 6 weeks of twice daily use     of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.   "
117257|NCT01751113|"     The purpose of this study is to evaluate the effects on lung function of a combination of     ADOAIR 50/250mcg twice daily plus tiotropium bromide 18mcg once daily compared with the     individual treatments (tiotropium bromide 18mcg once daily alone and ADOAIR 50/250mcg twice     daily alone) in Japanese subjects with COPD. The study will utilize a three-way cross-over     design with a 2-week wash-out period between each 4-week consecutive treatment period. The     aim is to support the rationale for triple combination therapy by demonstrating that     treatment with both ADOAIR and tiotropium can potentially produce improved, clinically     relevant effects compared with either treatment alone.      This study will utilize a range of lung function measures in order to fully assess the     benefits of triple therapy. The primary endpoint will be based on airways conductance     measured using plethysmography (sGaw measured over 4hours post dose (AUC 0-4hr) on Day 28).     Secondary endpoints will include lung function measures based on plethysmography and     spirometry. The lung function measures will be supported by measurement of the use of relief     salbutamol .   "
117258|NCT01751100|"     The purpose of this study is to see if offering a general health screening tailored towards     high-risk groups (African immigrants, injection drug users (IDUs), and minority men who have     sex with men (MSM)) will increase human immunodeficiency virus (HIV) testing, counseling, and     linkage acceptance rates in community pharmacies.   "
117259|NCT01751087|"     The purpose of this research study is to compare three different ways of opening a woman's     cervix before her second-trimester surgical abortion.        -  Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open          the cervix        -  Osmotic dilators plus mifepristone, a medicine that is swallowed        -  Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum      Hypotheses:        -  adding buccal misoprostol 3 hours preoperatively will significantly improve dilation          compared to laminaria alone, making procedures faster, easier and safer.        -  adding oral mifepristone at the time of laminaria placement will confer a similar          benefit.        -  the efficacy of adjunctive misoprostol and mifepristone will be influenced by          gestational age, with women later in gestation having increased efficacy from these          agents.        -  significantly more patients who receive adjunctive misoprostol or mifepristone will have          adequate initial dilation, fewer will require manual dilation or additional cervical          preparation and there will be fewer complications in these arms, although complication          rates will be low and we will only be able to detect relatively large differences.        -  patients will prefer to have the procedure done as quickly as possible with as little          discomfort as possible, that cervical ripening with adjunctive misoprostol will be          associated with more cramping than osmotic dilators alone and that mifepristone will be          well tolerated and may not cause more cramping or other side effects than osmotic          dilators alone.   "
117260|NCT01751074|"     The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low     and it would be helpful to quantify this risk in man in order to guide prescribing     physicians. The primary aims of this study are to estimate the potential effects of repeat     doses of Darapladib on the PK of Rosuvastatin as well as evaluating safety and tolerability.     Two part approaches are planned for this study. Part A of the study will examine the effects     of repeat doses Darapladib on the PK of Rosuvastatin in healthy volunteers of Caucasian     descent. Based on whether a significant increase in Rosuvastatin exposure is observed in     Caucasians in Part A, a decision will be made regarding whether to proceed with a conditional     Part B to examine this effect in healthy volunteers of Far-East Asian descent.      In both parts, subjects will receive Rosuvastatin 10 milligrams (mg) once daily (QD) for 1     day during the first treatment period (Treatment Period 1), followed by a 4 day PK sampling     period/wash-out. Subjects will then receive darapladib 160 mg QD for the next 10 days with     24-hour PK sampling on the last day (Day 14 of the study). Immediately following this, all     subjects will then receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1     day and continued Darapladib dosing of 160 mg QD for additional 3 days (Treatment Period 2)     while blood samples are collected to assess Rosuvastatin PK. Plasma samples collected on Day     15 will be analyzed for both Rosuvastatin and Darapladib concentrations.      Subjects will be required to return to the unit approximately 10 to 14 days following the     last dose of study medication for a clinic visit for assessments and then will return again     at 35 ±7 days following the last dose for the final follow-up visit of the study. The     duration of each subject's participation in the study from screening to follow-up will be     approximately three months.      Approximately 18 evaluable subjects will be enrolled in Part A and another 18 subjects will     be enrolled in Part B (if conducted) to complete dosing and all assessments.   "
117262|NCT01751048|"     Investigational products: LEISH-F3 (recombinant protein antigen) + GLA-SE (adjuvant)     leishmaniasis vaccine and LEISH-F3 (recombinant protein antigen) + MPL-SE (adjuvant)     leishmaniasis vaccine. Stage of development: Phase 1 clinical development. Healthy adult     subjects, 18 to 49 will be recruited through a U.S. site. Primary objective: To evaluate the     safety and tolerability of the LEISH-F3 + GLA-SE vaccine and the LEISH-F3 + MPL-SE vaccine     following intramuscular (IM) administration of 20 µg of LEISH-F3 together with 2 or 5 µg of     GLA-SE or 10 µg of MPL-SE on Days 0, 28, and 168. Secondary objective: To assess the     immunogenicity of LEISH-F3 formulated with GLA-SE, MPL-SE, or SE by evaluating IgG antibody     responses to LEISH-F3 at Days 0, 28, 56, 168, 196, and 365, and T cell responses to LEISH-F3     at Days 0, 14, 42, 168, 182, and 365. Each subject's duration of participation will be about     18 months.   "
117263|NCT01751035|"     Adolescents receiving RRFT and their caregivers will report significantly fewer substance use     problems (quantity of use, frequency of use, and abuse symptoms) during treatment and     follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents     receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk     and protective factors for substance use and abuse at the individual level (e.g., coping) and     at each level of an adolescent's ecology (e.g., increased number of positive family     activities, reduced family conflict, reduced number of peers who use drugs, improved school     attendance, increased involvement in pro-social community activities) during treatment and     follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will     experience less PTSD symptoms (per youth and caregiver reports) during treatment and     follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report     engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during     treatment and follow-up than control adolescents who receive TAU. Changes during treatment in     family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth     relationship) and parenting practices (monitoring) will mediate changes in substance use.     Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.   "
117264|NCT01751022|"     The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain     Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant     procedure. This study will also assess the interactions of the Attain Performa leads with the     entire Medtronic CRT-D system.   "
135449|NCT01511887|"     The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term     20-28 days old newborn referred to Bandarabbas children' hospital in 2011.   "
117267|NCT01750983|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to     patients with advanced cancer. The safety of these drugs will also be studied.      Ipilimumab is designed to increase the immune system's ability to fight cancer.      Lenalidomide is designed to change the body's immune system. It may also interfere with the     development of tiny blood vessels that help support tumor growth. This may decrease the     growth of cancer cells.   "
117268|NCT01750970|"     To confirm the benefit of endoscopic resection under fluorescence and blue light of high     grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection     recommended nowadays can be deleted.   "
117269|NCT01750957|"     This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the     safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with     fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523     or placebo orally daily for 12 weeks.   "
117270|NCT01750944|"     The main objective of this study is to evaluate the concordance of the variation in systolic     pressure indices measured at the toe and ankle after a walking test in healthy volunteers.   "
117271|NCT01750931|"     It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence,     single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by     Savipharm J.S.Cc, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co.     KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy, adult, human male subjects     under fed condition. It is a pivotal study to demonstrate the bioequivalence of Meloxicam GSK     15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer     Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy     adult human male subjects under fed condition.      This study will enroll 28 healthy adult human male subjects   "
117275|NCT01750879|"     The unifying objective of this project is to determine whether peanut oral immunotherapy (PN     OIT) induced clinical tolerance in the context of food allergy is significantly associated     with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is     thought to be inducible in the gut-associated lymphoid compartment and associated with     immunological tolerance.      The hypothesis of the study is that the induction of Treg cells will be associated with     clinical tolerance.      The investigators will measure the change from baseline of induced Treg cells as a frequency     of total CD4 T cells during active treatment and compare that between participants who     achieve significant clinical tolerance (Tolerance and Partial Tolerance Groups as defined     below) and those who do not (Treatment Failure Group).   "
117276|NCT01750866|"     Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients     with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to     better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and     older) with advanced prostate cancer who have progressed during or after treatment with     docetaxel. All patients on this study will receive cabazitaxel by intravenous (through a     vein) infusion plus prednisone by mouth twice daily, and following the chemotherapy     infusions, an injection of a granulocyte colony-stimulating factor (G-CSF). G-CSF will help     the body produce more white blood cells, which should help decrease the risk of getting an     infection while being treated with cabazitaxel.   "
117277|NCT01750853|"     The purpose of this study is to investigate the safety and tolerability of LY3045697 after a     single dose, and to determine how long LY3045697 remains in the body. Two cohorts (groups) of     9 participants each will participate in 3 dosing periods. These participants will receive     placebo in one period only. A third cohort of 9 will participate in 2 dosing periods and     participants will receive either 2 dose levels of LY3045697 or 1 dose level of LY3045697 and     placebo by the end of both periods.   "
117278|NCT01750840|"     The purpose of this clinical registry is to capture data on an ongoing basis from a     population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.   "
117279|NCT01750827|"     This will be an open-label, single dose, single period study. Approximately 14 subjects will     receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast.     This study will evaluate whether SB-659032 has an effect on platelet function as determined     by platelet aggregation tests using the agonists ADP and collagen. Blood samples for PK     analysis and measurement of Lp-PLA2 activity will also be collected   "
117280|NCT01750814|"     The primary objective is to demonstrate the immunological non-inferiority between GC3102C and     GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults   "
117281|NCT01750801|"     Characterization of green propolis and development of mouthwash containing propolis to     control plaque and gingivitis. A Phase I.   "
117282|NCT01750788|"     This is an international observational study in patients with non-valvular atrial     fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent     stroke or non-central nervous system systemic embolism.   "
117283|NCT01750775|"     The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin     capsule for sinus bradycardia complicated with ventricular premature beats.   "
117284|NCT01750762|"     This research is a Phase I clinical trial. Phase I clinical trials test the safety of an     investigational drug. Phase I studies also try to define the appropriate dose of the     investigational drug to use for further studies. Investigational means that the drug is     still being studied and that research doctors are trying to find out more about it. It also     means that the FDA has not approved lenalidomide for your type of cancer.      Lenalidomide is a drug that alters the immune system and it may also interfere with the     development of tiny blood vessels that help support tumor growth. Therefore, this study will     determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved     by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in     combination with dexamethasone for patients with multiple myeloma (MM) who have received at     least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a     variety of cancer conditions. In this case it is considered experimental.      There are some participants with multiple myeloma or lymphoma who have had very long     remissions after a bone marrow/stem cell transplantation from another person. This is     believed to be the effect of the donor's immune system reaction against the recipient's     multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it     might be able to potentiate that reaction. This study is being done to determine if the use     of lenalidomide is safe in transplant participants and if it can facilitate an immune     reaction resulting in regression of the myeloma or lymphoma.      During this study you will be evaluated for side effects from the treatment with lenalidomide     (including graft versus host disease) and for response of the myeloma to the treatment. There     will be two groups of participants in the study. The first group will be treated at a     relatively low dose of lenalidomide. If this is found to be safe then the second group will     be treated at a higher dose   "
117285|NCT01750749|"     Chronic venous leg ulcers (CVU) represent a medical problem associated with significant     morbidity, increased work absenteeism and earlier retirement as a consequence of disability.     This strongly affects the patient's quality of life and has a significant economic impact on     healthcare systems.      Reports of studies with animal models show that treatment with bone marrow-derived stem cells     has a beneficial effect in healing chronic skin wounds.      The purpose of this pilot study is to determine the safety and feasibility of cell therapy     with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous     leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot     study will be used to refine the clinical protocol procedures of a subsequent randomized     study.      Patients with venous legs ulcers meeting eligibility criteria and providing appropriate     written informed consent will be enrolled for study participation. Enrolled patients will     receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care     (SOC) treatment.      During follow up, adverse events will be assessed by ulcer clinical examination.     Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing     (reduction of the ulcer area) and pain reduction over a six-month period.   "
117286|NCT01750736|"     Manual therapy and exercise have shown to be beneficial for people with neck pain, however it     is not clear how outcomes following a general exercise program compare to specific exercises     intended to augment a specific manual/hands-on intervention. This study will compare outcomes     following manual therapy and a specific exercise program with manual therapy and a general     exercise program.   "
117287|NCT01750723|"     In this study the investigators will research the hypothesis that the drug Acetazolamide     induce headache and dilation of cerebral arteries and increase the cerebral blood flow in the     areas of the brain supplied by these arteries.   "
117290|NCT01750684|"     To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses over     30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).   "
117291|NCT01750671|"     It is established that the surviving patients after a stay in the ICU are characterized by     frequent malnutrition and morbidity and mortality. The main goal of this work is to study the     relationship between nutritional statuses during ICU hospitalization, whatever its     determinants, and quality of life, morbidity and mortality at one year.      The hypothesis of the study is that the presence of under nutrition is responsible for a 10%     increase in crude mortality at one year (which would be respectively 30% for malnourished     patients and 20% for non-malnourished patients).   "
117292|NCT01750658|"     ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200     patients during a COPD exacerbation.   "
117293|NCT01750645|"     Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency,     and sometimes urinary incontinence; its etiology may be characterized as neurogenic or     non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one     of the available treatments is the injection of Botulinum Toxin. This study aims to review     the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive     Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the     controlled randomized clinical trials were chosen to review with the CONSORT criteria by     independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving     the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment,     change in quality of life and urodynamic measures.   "
117294|NCT01750632|"     Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed     testicular tissue is examined for presence of sperm and cryopreserved in small pieces for     fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a     biobank.   "
117295|NCT01750619|"     To evaluate clinical outcome for patients receiving treatment of suspected premalignant and     malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome     is curative endoscopic resection. Secondary outcomes include resection technique utilized,     rates of en bloc resection and adverse event rates, including infection, bleeding,     perforation and death, and one-year survival rates.   "
117296|NCT01750606|"     Retrospective study to comply with FDA's post-market surveillance order. The purpose of the     study is to contact patients who have received a Biomet metal-on-metal product as their     primary total hip arthroplasty device. Patients who have not been revised prior to contact     will be asked to submit to a blood draw, clinical exam and MRI.   "
117297|NCT01750593|"     Thyroid nodules are common problems and although > 95% are stated to be benign, they may     cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with     their function, size and localization. Especially for these nodules, patients undergo surgery     and face up with the problems associated with surgical complications although they are not     cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors     like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid     nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to     use this method in our patients having nodules like previously mentioned and see the efficacy     and safety of the technique.   "
117298|NCT01750580|"     To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and     identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with     ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.   "
117299|NCT01750567|"     Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated     medication. More recently metformin has been shown to act against carcinomas by two     mechanisms: 1) an indirect, insulin‐dependent mechanism which sensitizes tissues to insulin,     inhibits hepatic gluconeogenesis, and stimulates uptake of glucose in muscle, thereby     reducing fasting blood glucose and circulating levels of insulin, lowering the pro survival     activity of the insulin/INSR axis, and 2) a direct, insulin‐independent mechanism which     activates the AMP‐activated protein kinase (AMPK) pathway and leads to inhibition of the mTOR     pathway. Given the investigators preliminary published data on insulin and mTOR inhibition[1]     metformin is an attractive candidate for a pilot clinical trial in CLL patients.   "
117925|NCT01742390|"     This trial designed to investigate the effect of switching to aripiprazole from risperidone     or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in     adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.   "
117300|NCT01750554|"     The investigators are proposing to continue investigation to improve the accuracy of the SpHb     (continuous hemoglobin monitoring device) by administering an intermediate acting digital     nerve block in the finger connected to the SpHb, specifically bupivacaine 0.25% in patients     undergoing spine surgery. Bupivacaine is FDA approved and in routine use.   "
117301|NCT01750541|"     The aim of this study is to compare the efficacy of haloperidol and valproate in management     of people with agitation in emergency department   "
117302|NCT01750528|"     1. Our hypotheses on the relationship between periodontitis and AS are as follows;             -  The prevalence of periodontitis is higher in AS patients group than that of non-AS               control group             -  Anti-TNF-α therapy would favorably affect the disease course of periodontitis.        2. Based on our hypotheses, the specific objectives of the present proposal are as follows;             -  The primary objective is to compare the prevalence rate of periodontitis between AS               patient group and non-AS group.             -  The secondary objectives will be:                  -  To observe the carriage rate of P. gingivalis in AS and non-AS groups                  -  To identify clinical parameters associated with the severity of periodontitis                    in AS group.                  -  To compare the progression of periodontitis at weeks 12 and 24 between AS and                    non-AS groups or between AS patients with and without anti-TNF-α treatment   "
117314|NCT01750372|"     Standardized outcome measures can be used to document patient health outcomes and improve     treatment of those requiring prosthetic and orthotic (O&P) services. Though numerous     instruments have been developed, existing measures of O&P outcomes have serious shortcomings     including limited evidence that the scores are responsive to clinical changes.      The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using     modern measurement methods to be a brief, precise and flexible measure of mobility for     persons with lower limb amputation (LLA). The investigators propose the following objectives     to achieve this goal.      Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower     limb loss      Key objective 2: study health profiles of lower limb prosthetic users      Key objective 3: validate the measure in a longitudinal study of people receiving replacement     prosthetic limbs      Key objective 4: study longitudinal health patterns of persons with lower limb amputation   "
117303|NCT01750515|"     Objective: to study the effect of Acupuncture on liver cirrhosis, SVR and health related     quality of life in HCV patients receiving standard treatment (Peg Interferon+ Ribavirin).      Methods: 60 HCV patients receiving standard treatment (Peg Interferon+ Ribavirin) will     undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant     immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) to achieve baseline     characteristics(17,18,19). Patients will be randomized into intervention and control groups,     30 patients each.In the Intervention group each patient will receive an acupuncture treatment     once a week for 12 consecutive weeks(Max 12, Min 8 treatments). Treatment protocol will be     individualized for each patient according to TCM diagnosis. This treatment protocol is     acceptable and has been published(20,21,22).In the control group patients will receive     standard treatment alone, with no other intervention.      Data collection: after 12 weeks patients will again undergo Serologic screening for hepatitis     C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound     Elastography (FibroScan) in order to detect changes from baseline and group differences.      Inclusion criteria: adult patients with a confirmed HCV infection      Exclusion criteria:      Under 18 years Can not receive standard Peg interferon+ ribavirin treatment for any reason     Psychiatric diagnosis Anaemia of hematologic origin Diabetic patient with uncontrolled     diabetes Congestive heart failure, arrhythmia Hepatocellular carcinoma HIV infection     Hepatitis B infection Auto immune liver disease or alcoholic liver disease Study duration: 1     year Study Location: Ziv medical center, division of liver disease, Israel   "
117304|NCT01750502|"     Macrophage migration inhibitory factor (MIF) is a pleiotropic cytokine that promote the     inflammatory response.In animal studies, it has been found that MIF is released in the     ischaemic heart, promoting glucose uptake and protecting the heart from ischaemia-reperfusion     injury.The MIF concentration, influenced by age and myocardial ischemia, have different     impact on myocardial functional recovery after ischemia.Therefore, the purpose of this     experiment is to study the clinical significance of MIF in patients with coronary heart     disease.   "
117305|NCT01750489|"     The objective of the project is to better understand the causes of exercise limitation,     dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators     aim to explore the mutual interaction of neurohumoral activation and exercise limitation     thereby focussing on differential effects of the peripheral muscle and the diaphragm.      Eventually the findings might influence treatment modalities. If sympathetic activation     contributes to exercise limitation then drugs influencing the autonomic nervous system would     be a reasonable therapeutic concept. If a reduction of sympathetic activity due to an     alteration of the ergoreflex can be achieved by non-invasive ventilation this would help to     improve dyspnea and exercise capacity.   "
117306|NCT01750476|"     The investigators are conducting a research study to understand how cells responsible for     fighting infection (immune cells) are affected by hormonal contraceptive use. The     investigators hypothesize that progestin-containing hormonal contraceptives (i.e.,     Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators     will collect blood and genital tract samples from women before and after their initiation of     a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).   "
117307|NCT01750463|"     This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive     Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin     concentration in critically ill children.   "
117308|NCT01750450|"     The investigators will generate pressure-flow loops and pressure-volume loops from aortic and     left ventricular pressure waveforms and Doppler (desc. aorta) flow waveforms and compare left     ventricular to arterial pressure-flow and pressure-volume loops as well as to cardiac power     from the USCOM 1A device. The goal of this study is to test the hypothesis that non-invasive     estimates of cardiac pressure-volume work (derived from ultrasound-based measurements)     correlate with invasive estimates.   "
117309|NCT01750437|"     Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to     investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive     reflux disease(NERD)   "
117310|NCT01750424|"     The purpose of this study is to assess scar-formation and wound healing following the use of     autologous fat grafting in facial reconstruction patients. Patients who have undergone facial     reconstruction in the last 3 months will be randomized into two groups, one receiving fat     grafting and one not receiving any intervention. These patients will continue to follow-up in     our clinic for one year, with 3-D images taken at each follow-up visit to assess scar     formation and wound healing. Assessment of the scar will be undertaken by both healthcare     personnel as well as general lay public. We hypothesize that patients undergoing fat grafting     to the wound site will achieve a more aesthetically appealing result, with less scarring and     improved wound healing as judged by both the general public and healthcare professionals.   "
117311|NCT01750411|"     The mission of SARP is to improve the understanding of severe asthma through the integrated     study of the effect of genetics on the clinical and biological features of asthma and to     investigate how these change over time. The ultimate goal of these efforts is to promote     better treatments for severe asthma.   "
117312|NCT01750398|"     The purpose of this study is to determine the safety and clinical effects of alternating     androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer     as first line hormonal therapy, to assess the effect of alternating therapy on quality of     life and metabolic changes associated with androgen-deprivation therapy.   "
117313|NCT01750385|"     Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia     because it is safer and more effective than traditional Heller's myotomy. However, the issue     of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we     conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin     levels in order to preliminary observe whether antibiotic prophylaxis is needed.   "
117328|NCT01750177|"     The purpose is to investigate the effect of sedentary screen time activities on food intake     and subjective appetite in 9- to 14-year old normal weight and overweight/obese girls. The     investigators hypothesize that pre-meal exposure to screen time activities for 45 minutes     increases subjective appetite and food intake at the next meal. Food intake will be measured     immediately following screen-time exposure, and subjective appetite measured throughout the     study period at 0, 15, 30, 45 and 75 minutes.   "
117315|NCT01750359|"     Antidepressants generally do not lead to an immediate relief of symptoms. Most people will     not see a significant improvement for at least 4 weeks. Studies have generally shown that the     full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this     timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated from     this perennial herb. It possesses a variety of pharmacological activities, including     anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has     been found to possess antidepressant action in various animal models of depression. Chronic     administration of curcumin has been reported to exert antidepressant-like action in olfactory     bulbectomy model of depression in rats. Although the mechanism of the antidepressant effect     of curcumin is not fully understood, it is hypothesized that it acts through inhibiting the     monoamine oxidase enzyme and modulating the release of serotonin and dopamine.In randomized,     double-blind, placebo-controlled study 40 patients will be randomized to receive either 500     mg/day of curcumin or placebo together with antidepressants for 6 weeks.   "
117316|NCT01750346|"     Background:      - Blepharospasm is caused by excessive contraction of the muscles that close the eye. One     treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT,     acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream.     AH-8 is the active ingredient in a number of cosmetic creams used to treat wrinkles.     Researchers thought that AH-8 cream could be used to treat blepharospasm, but the original     dose studied was not very effective. They want to try a higher dose of AH-8 in a cream to see     if it can be a more effective treatment.      Objectives:      - To see if AH-8 cream can improve the symptoms of blepharospasm.      Eligibility:      - Individuals at least 18 years of age who have blepharospasm that is severe enough to     require treatment.      Design:        -  This study will involve up to eight study visits.        -  Participants will be screened with a physical exam and medical history. They will answer          questions about their symptoms. They will also have a blink test to see how severe the          blepharospasm is. At this visit, participants will receive one of three types of cream.          One cream will have a low dose of AH-8, one will have a higher dose of AH-8, and the          other will be a placebo (no AH-8).        -  One month later, participants will have a followup visit, with tests similar to the          first visit. They will also receive more of the cream.        -  One month later, participants will have another visit with the same tests. They will be          videotaped at this visit to study their facial movements. Those who have responded to          the treatment will continue to use the cream. Those who have not responded will be          offered the chance to have BoNT injections, and will stop taking the cream.        -  One month later, participants who had BoNT injections will have a final visit to check          for possible side effects. Those who continued to take the cream will continue on the          study.        -  The fifth and sixth visits will involve the same tests as before. At the seventh visit,          remaining participants will be offered the chance to have BoNT injections, and will stop          taking the cream.        -  The final visit will check for any side effects from the cream or the injections.   "
117317|NCT01750333|"     The aim of this study is to explore whether and how high circulating levels of endothelin-1     (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production,     release and vascular activity   "
117318|NCT01750307|"     Brief summary      The aim of the study is to provide preliminary data on the relationship of Essential Fatty     Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural     functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This     main aim will be achieved in two ways. First the investigators will measure the relationship     of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the     potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and     behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which     changes in neuronal activity and cognitive performance are related to behavioural and     functional measures over time. This is to be carried out by conducting a randomised     controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and     Cognitive Effects in Adult Neurodevelopment).      The study design will be a 6-month double blind placebo control study with a group of 80     adults with a diagnosis of ADHD. The group will be divided into 40 participants who receive     EFA dietary supplements and 40 who receive placebo, over a 6-month period. Allocation to EFA     dietary supplementation and placebo groups will be randomly allocated and blind to both the     investigator and participants. In addition a sample of 30 controls will take part in baseline     levels of assessment and be used for case-control comparisons to investigate the links     between EFA blood levels and cognitive-electrophysiological function at one time point.      The study design will enable preliminary data to address the following hypotheses:        1. Changes in cognitive and electrophysiological function (neuronal activity) will be found          following supplementation with dietary EFAs.        2. Changes in cognition and/or brain activity will be related to blood levels of EFAs.        3. Changes in cognitive performance and electrophysiological parameters will correlate with          behavioural function, affective regulation or functional impairments.        4. At baseline, case-control differences in EFA blood-levels will be found which will be          linked to cognitive and electrophysiological function.   "
117319|NCT01750294|"     It is estimated that in the United States there are approximately 8 million individuals with     moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an     important role in the pathogenesis of hypertension in patients with CKD. For this pilot     study, the investigators hypothesize that administration of chlorthalidone among patients     with moderate to severe CKD will improve blood pressure (BP).   "
117539|NCT01747434|"     Acute patients in Denmark are often admitted to Emergency Departments by their General     Practitioner with a presumptive diagnosis.      The aim of this study is to evaluate the diagnostic value of the pre-admission presumptive     diagnosis and to assess if the presumptive diagnosis could be replaced by a number of     symptom-based groups.   "
117320|NCT01750281|"     The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with     a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2     vs placebo and compare how well each dose affects how their cancer responds. It will also     help us to understand the tolerability profile of the different dosing regimens in these     patients   "
117321|NCT01750268|"     The goal of the proposed project is to improve the treatment of veterans with co-occurring     traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators     will conduct a pilot controlled clinical trial of topiramate for the treatment of these     co-occurring disorders.   "
117322|NCT01750255|"     This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve     compliance and adherence rate, associated with greater effectiveness and safety of drug     therapy to help achieve therapeutic goals, and finally to improving the quality of life of     patients.   "
117323|NCT01750242|"     To evaluate DBS device settings and match with the features of the DBS care management     software.   "
117324|NCT01750229|"     The purpose of this study is to evaluate the role of frequency settings on spinal cord     stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).   "
117325|NCT01750216|"     This observational study will evaluate the predictive value of rapid virological response     (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage     of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated     on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be     followed for 48 weeks of treatment and up to 24 weeks of follow-up.   "
117326|NCT01750203|"     The objective of this study is to collect wound exudate (fluid) swab samples from Subjects     who have wounds that show clinical signs of infection, as well as from Subjects who have     wounds that do not show clinical signs of infection. Swab samples will be collected from     acute and chronic wounds of different etiologies and these will be analysed for bacteria     types and markers of infection.   "
117327|NCT01750190|"     The purpose of this study is to determine whether FG-4592 is safe and effective in the     treatment of anemia in chronic kidney disease patients who are not on dialysis.   "
117339|NCT01750034|"     The purpose of this study is to better understand how to best care for burn wounds.   "
123992|NCT01662830|"     The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump     Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes,     and reduction in common markers of coronary heart disease.   "
117329|NCT01750164|"     This study will use tissue or body fluid acquired during standard procedures that are part of     the patient's care for their cancer, such as surgery to remove tumor tissue or needle     withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into     immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The     tissue will then be extracted and either frozen, embedded in paraffin, or used for     engraftment into another generation of mice. The second generation mice will be separated     into groups and given various treatments.      Tissue from the participants and from the mouse established tumors, in which the mice have     either received treatment or have not received treatment, will be used to evaluate the levels     of various genes that assist in regulating cell growth and cell death. The tumor tissue from     participants and mice will also be tested for random changes in the genetic material and     compared to the participant's blood to determine if any of the changes in the genetic     material correlate with better engraftment of the patient tissue in the mice. It is     anticipated that 10-30% will have successful engraftment of tumor tissue   "
117330|NCT01750151|"     The purpose of this experiment is to investigate the effect of video game playing for 30     minutes on food intake and subjective appetite. The investigators hypothesize that video game     playing will affect food intake in children. Food intake will be measured at 30 minutes     following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg     Sucralose® in 250ml of water) beverage with or without video game playing. Subjective     appetite will be measured at 0, 20, 35 and 65 minutes.   "
117331|NCT01750138|"     The gastrointestinal tract has many functions; it provides nutrition, produces hormones,     performs a barrier function, maintains a stable gastrointestinal micro flora and plays an     important role in the inflammatory process as it is the largest producer of cytokines     (proteins associated with inflammation). This gut function is impaired after colorectal     (bowel) surgery. There is evidence to suggest that impaired gut function is associated with     increased complications. Hence if gut function is preserved, it should equate with better     outcomes. As a result, there has been increasing interest in treatments called Gut Specific     Nutrients (GSN), which specifically target gut function. Most notable of them is Glutamine, a     conditionally essential amino acid and preferred fuel source for intestinal cells. Research     has shown that glutamine promotes cell growth, increases clearance of harmful organisms from     the blood, and reduces the surgical stress response. In other words, glutamine has a     favourable influence on gut function.      Recent studies from our unit using intravenous glutamine in critically ill patients have     shown an early return of gut function, which in turn is associated with attenuation of the     inflammatory response and improved outcomes. It is not known whether oral glutamine is     associated with a similar outcome. A recent pilot study at our unit suggests an association     between oral glutamine and early return of gut function. The aim of this research is to     determine if giving oral glutamine results in an early return of gut function and whether     this is associated with an attenuation of the systemic inflammatory response.   "
117332|NCT01750125|"     The investigators hypothesize that performance of fast-Fourier transformation on the raw     Doppler signals obtained from ascending aortic blood flow will recreate the pulse wave     Doppler trace visualized on modern echocardiography machines, and that this will allow for     the measurement and recording of vascular flow waveforms   "
117333|NCT01750112|"     This is a prospective, open, non-comparative and baseline-controlled study to evaluate     efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum     deformity.      Each subject participating in the study will be treated with approximately 50-150 ml of     Macrolane VRF20. The amount of study product used will be individually determined in order to     achieve an optimal correction of the deformity in each subject.   "
117334|NCT01750099|"     This study divides patients into two groups when they ask for medicine to help relieve the     pain of contractions. One group will be selected to receive an epidural and another group     will be selected to receive both a spinal dose and an epidural. The investigators will then     measure how long it takes to deliver the baby. The investigators think that the group that     has the combination spinal and epidural will have a faster labor.   "
117335|NCT01750086|"     The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis     medications when combined with teriparatide.   "
117336|NCT01750073|"     This phase II trial studies the side effects and how well giving paclitaxel and     cyclophosphamide with or without trastuzumab before surgery works in treating patients with     previously untreated stage I-III breast cancer. Drugs used in chemotherapy, such as     paclitaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Giving combination chemotherapy with or without trastuzumab before     surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be     removed   "
117337|NCT01750060|"     This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence     design. A total of 54 eligible subjects will receive three total treatments; one with     intravenous (IV) infusion and two with the Study System. Each subject will be randomly     assigned to receive a treatment sequence consisting of Treatment A (IV fentanyl citrate),     Study System Treatment B (170 mcAmp), and one of three additional Study System treatments     (140 mcAmp or 200 mcAmp or 230 mcAmp)    "
117338|NCT01750047|"     Object: Every person's pain perception and possible postoperative pain is different. As the     investigators know, they are affected by many factors. However, the investigators don't know     whether the smoking factors, alcohol factors, surgery type, education background, etc. will     affect individual pain perception and possible postoperative pain in Chinese population. This     study was conducted to investigate the power of these possible affect factors. Method:     Patients receiving elective surgery under general anesthesia were recruited into this study.     The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain     tolerance (PTO)and also investigated the patient's personal information of smoking factors,     alcohol factors, surgery type, education background, etc. In addition, we retrospectively     investigated the visual analog scale (VAS) during patient-controlled analgesia (PCA)     treatment 0 to 48 h after operation as well as the PCA press frequency and drug consumption     of those patients who received PCA administration.   "
117340|NCT01750021|"     Obesity has become a global epidemic, and treating and preventing obesity appears to be one     of the world's greatest challenges. The disorder is associated with a wide range of metabolic     and hormonal changes, including the development of insulin resistance, changes in adipose     tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced     fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage     capacity and increased exchange of lipids between adipose tissue and blood, and increased     secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in     the regulation of adipose tissue, the size of adipocytes and other metabolic conditions.      The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for     the body's energy storages. The central role of the liver in energy supply, fat storage and     normalization of blood values implies the importance of investigating the interaction between     adipose tissue and liver to increase knowledge about the morbidity of obesity. Central     obesity and insulin resistance are clear risk factors for the development of fatty liver, but     the importance of diet is unclear. The common perception is that fatty liver condition can be     improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and     contradictory findings occur in epidemiological studies. It is therefore necessary to better     understand the impact of the different macro-nutrients.      The purpose of this study is to determine whether two weight reducing diets with equal     calorie levels that contain high or low fat differentially affects the adipose tissue     function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory     markers, lipids, vitamins, hormones and other substances that may be related to metabolically     health.   "
117341|NCT01750008|"     The purpose of this study is to compare the outcomes of two uterine-conserving treatment     alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global     fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard     step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating     laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have     equal access to valuable imaging information and to plan treatment accordingly. By     randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one     treatment or the other following the LUS is eliminated.   "
117342|NCT01749995|"     A Comprehensive Geriatric Assessment (CGA) has become a fundamental aid in the evaluation and     treatment planning of older cancer patients. Systematic reviews of trials of geriatric     assessments have shown effectiveness when interventions are implemented. Although CGA is a     fundamental tool in the care of the geriatric patient, the integration and application of     this tool in oncologic practice are still in evolution. Cognition is one of the domains     examined within a CGA. Studies have noted that up to 25% to 50% of older patients had     cognitive abnormalities that warranted further evaluation. Cognitive dysfunctions can     influence the ability to weigh the risks and benefits of cancer therapy, to comply with the     suggested treatment plan, and to recognize the symptoms of toxicity that need medical     attention. Recently, the Freund Clock Drawing Test (CDT) has been proposed as a quick and     simple screening tool to assess cognitive dysfunction. A retrospective analysis on 105 cancer     patients at the General Hospital Groeninge showed that a cut-off score of ≤ 4 for the CDT has     a good AUC, sensitivity and specificity.      Aims        1. To validate the Clock Drawing Test as a screening tool to identify elderly cancer          patients in need of a more in-depth cognitive evaluation within a comprehensive          geriatric assessment (CGA)        2. Further registration of data in a database coupled to the Cancer Registry in the General          Hospital Groeninge as set up by the PROGERCAN study   "
117356|NCT01748838|"     The purpose of this study is to assess the safety and tolerability of CTX-4430 capsules taken     orally once daily in normal healthy volunteers. CTX-4430 is being developed to treat lung     inflammation that occurs in cystic fibrosis (CF). This study includes two-parts: Part 1     assesses single dosing; and Part 2 assesses repeat dosing for 14 days. Each part will include     several dosages. During the single-dose part of the study, following a 14-day washout period,     two cohorts will be assessed for potential effects on tolerability when fed at the time of     dosing. For both parts of the study, blood samples will be collected for PK assay validation.   "
135450|NCT01511874|"     The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the     treatment of subjects with prostate cancer.   "
117343|NCT01749982|"     Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking     water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L.     Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart     disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on     one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine     (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for     the recruitment and transfer of methyl groups, but other nutrients, including choline and     betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study     of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show     that plasma choline and betaine concentrations are positively associated with As methylation.     These findings suggest that choline and/or betaine may play an important role in As     methylation and elimination and that simple interventions may have therapeutic potential for     the many populations at risk for As-induced health effects.      The investigators aim to recruit and follow 60 participants for this pilot study which will     allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor     participants for any potential side effects, 3) identify any difficulties that might be     encountered in daily follow-up, and 4) generate preliminary data regarding the effects of     choline and/or betaine supplementation on arsenic methylation.   "
117344|NCT01749969|"     Primary Objectives:        -  To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and          dexamethasone (LD) in patients with relapsed or refractory multiple myeloma.        -  Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity          (objective response rate [ORR]) of SAR650984 (isatuximab) in combination with LD using          International Myeloma Working Group (IMWG) criteria.      Secondary Objectives:        -  To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in          combination with LD in relapsed or refractory multiple myeloma. The severity, frequency          and incidence of all toxicities will be assessed.        -  To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in          combination with LD and the PK of lenalidomide in combination with SAR650984 and          dexamethasone.        -  To assess the relationship between clinical (adverse event [AE] and/or tumor response)          effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative          laboratory) results.        -  For the dose expansion phase, estimate the activity (ORR) using IMWG defined response          criteria of SAR650984 (isatuximab) plus LD.        -  To describe progression-free survival (PFS) in patients treated with this combination.   "
117345|NCT01749956|"     The purpose of this Phase II study will be to investigate the antiangiogenic agent,     aflibercept, in combination with chemoradiation as preoperative treatment for patients with     stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.   "
117346|NCT01749943|"     Evaluate a method of testing the strength of five key lower limb muscle groups using a     hand-held strength gauge (dynamometer).   "
117359|NCT01748799|"     The purpose of this study is to to demonstrate the feasibility and tolerability of the use of     Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated     dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on     withdrawal symptoms, craving scores and cannabis consumption during the study period.   "
117347|NCT01749930|"     In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT),     the primary objective is to demonstrate that the mean IOP reduction after 3 months of     treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice     daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to     timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of     BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be     conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X     QD for an additional 3 months.   "
117348|NCT01749917|"     The investigators conducted an intervention based in proprioceptive exercises and balance     tasks. The investigators also carried out a brief intervention in manual dexterity.      The study hypothesis is that a brief intervention in upper extremities and a exercise program     can increase functionality in Parkinson.   "
117349|NCT01749904|"     In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT),     the primary objective is to demonstrate that the mean IOP reduction after 3 months of     treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice     daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to     timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of     BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be     conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X     QD for an additional 9 months.   "
117350|NCT01749891|"     The general objective of this study is to evaluate the safety and efficacy of ophthalmic     intravitreal injections of ALG-1001 in human subjects with wet age-related macular     degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous     animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema     patients.   "
117351|NCT01749878|"     Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind     study of the safety, tolerability, and bioeffect of REGN1500   "
117352|NCT01749865|"     This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who     underwent radical resection will be included. The patients will be randomized to group A     (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer     treatment after resection of HCC, and the randomize ratio will be 1:1.   "
117353|NCT01749852|"     The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body     weight/ body fat in the overweight and obese adult population.   "
117354|NCT01748864|"     A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in     normal volunteers. Study will determine biodistribution and excretion of the radioactive drug     substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal     volunteers.   "
117355|NCT01748851|"     The purpose of this study is to identify the non-inferiority of the combination therapy of     Capecitabine and Oxaliplatin compared with the combination therapy of Fluorouracil/Folinic     acid and Oxaliplatin in patients with advanced gastric cancer.   "
117357|NCT01748825|"     BACKGROUND:        -  Wee1 is a tyrosine kinase involved in the phosphorylation and inactivation of          cyclin-dependent kinase 1 (CDK1/CDC2)-bound cyclin B, resulting in G2 cell cycle arrest          in response to DNA damage to allow time for DNA repair. Recent preclinical data          additionally implicates Wee1 in maintenance of genomic integrity during S phase.        -  AZD1775 is a selective inhibitor of Wee1 kinase. Recent preclinical model data          additionally show single agent anti-tumor activity in multiple cancer cell lines and          tumor xenografts.        -  Preliminary data show AZD1775 is tolerable at lower doses in combination with          chemotherapeutic agents. We propose to demonstrate single-agent activity for AZD1775.      PRIMARY OBJECTIVE:        -  To establish the safety and tolerability of single-agent AZD1775 in patients with          refractory solid tumors        -  To determine the pharmacokinetics of AZD1775 in patients with refractory solid tumors      SECONDARY OBJECTIVES:        -  To determine the effect of AZD1775 on markers of DNA damage and apoptosis in tumor          tissue and circulating tumor cells        -  To evaluate the antitumor activity of AZD1775 in patients with refractory solid tumors        -  To assess whether sufficient Wee1 inhibition is maintained throughout the therapeutic          regimen.      ELIGIBILITY:        -  Patients must have histologically confirmed solid tumors for which all standard therapy          known to prolong survival have failed, or for which standard therapies do not exist.        -  No major surgery, radiation, or chemotherapy within 3 weeks or (5 half-lives, whichever          is shorter) prior to entering the study.        -  Adequate organ function      STUDY DESIGN:        -  This study will follow a traditional 3+3 design.        -  In Cohort A starting at dose level 1, AZD1775 will be administered orally, BID, for 5          doses (D1-3) during each cycle. Starting at dose level 2 and onwards, AZD1775 will be          administered orally, BID, for 5 doses for the first 2 weeks of each cycle (D1-3 and 8-          10). Each cycle is 21 days (+/- 1 day for scheduling).        -  Once MTD is established, 6 additional patients will be enrolled at the MTD to further          evaluate that dose for PK and PD endpoints.        -  A further expansion cohort of 6 additional patients with documented tumors harboring          BRCA-1 or -2 mutations will also be enrolled at the MTD to further explore the safety of          the agent and obtain preliminary evidence of activity in this patient population.        -  Based on preliminary evidence of drug activity in an alternative once-daily dosing          schedule, patients without a documented BRCA mutation will be accrued to a once-daily          dosing schedule Cohort B, with mandatory paired tumor biopsies at the maximum tolerated          single daily dose, to further evaluate PD endpoints. AZD1775 will be administered orally          once daily for 5 days (D1-5 and 8-12) during weeks 1 and 2 of each 21-day cycle (+/- 1          day for scheduling).        -  During the escalation phase, tumor biopsies will be optional and will be evaluated for          pharmacodynamic (PD) studies for evidence of Wee1 inhibition DNA damage and repair, and          apoptosis (yH2AX, pNbs1, Rad51, pTyr15-Cdk and caspase 3). During the expansion phase,          once MTD is reached, mandatory paired tumor biopsies will be pursued in up to 20          additional patients enrolled at the MTD to further evaluate PD endpoints.   "
117358|NCT01748812|"     Background:        -  Hypophosphatemia is a condition where a person has low levels of phosphorus in the          blood. Low blood phosphorus can cause muscle and bone weakness (such as rickets) and          teeth problems. One cause of the condition is having too much fibroblast growth factor          23 (FGF23). FGF23 is a hormone that causes the kidney to get rid of phosphorus in the          urine. It can also prevent the body from making vitamin D, which helps the body absorb          phosphorus in food.        -  Many people with low blood phosphorus take high doses of phosphorus and calcium          medications. However, one side effect of these drugs is increased blood levels of          parathyroid hormone (PTH). The drug cinacalcet can help lower PTH levels, which may          decrease the amount of phosphorus lost in the urine and increase the phosphorus levels          in the blood. Researchers want to see if cinacalcet can help blood phosphorus and          decrease the amount of phosphorus supplements that people need to take.      Objectives:      - To see if cinacalcet can be a safe and effective treatment for people with low phosphorus     conditions due to high FGF23.      Eligibility:      - Individuals between 18 and 70 years of age who have different forms of hypophosphatemic     rickets and tumor-induced hypophosphatemia      Design:        -  Participants will have up to 25 study visits over about 28 weeks.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Up to three more lab visits for blood and urine tests will be required before treatment.          Imaging studies of the bones, spine, and kidneys will be performed.        -  Participants will have a 3-night hospital stay to start treatment. They will take          cinacalcet once a day. Treatment will be monitored with frequent blood tests and imaging          studies.        -  Participants will continue to take cinacalcet once a day for 3 weeks. They will have          regular study visits to monitor the treatment.        -  There will be up to two other overnight hospital stays (1 to 3 nights) to adjust          cinacalcet doses. The dose will increase until the maximum dose is reached, or side          effects develop.        -  After the end of the cinacalcet study, participants will have several more followup          visits to monitor the effects of treatment.   "
117360|NCT01748786|"     The purpose of this study is to compare an online 12-module intervention designed to improve     emotion regulation and social relations via mindfulness training with a 12-module program     that provides information about health behaviors to individuals with fibromyalgia. The     mindfulness training program is expected to produce greater day-to-day improvements than the     education condition in individuals' efficacy for coping with pain and stress, positive and     negative affect, and positive engagement in social relations assessed via online diaries     completed each evening during the intervention period.   "
117361|NCT01748773|"     This single-arm, open-label study will evaluate the safety and efficacy of the combination     oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in     participants with curatively resected HER2+ gastric or gastroesophageal junction cancer.     Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on     Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin     100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850     mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during     chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25     doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time     on study treatment is 1 year plus a 1-year follow-up period.   "
117362|NCT01748760|"     This study is to develop an adjunctive intervention for acutely suicidal adolescents who have     been admitted to a psychiatric inpatient unit. The study intervention is comprised of: 1) two     to three individual sessions delivered in an inpatient setting or immediately upon discharge;     2) one family session; 3) six months of follow-up phone interventions. The investigators     hypothesize that those who receive the study intervention will have lower rates of suicide     events and greater decreases in suicidal ideation after six months.   "
117363|NCT01748747|"     This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with     stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help     the body build an effective immune response to kill tumor cell tumor cells. Biological     therapies, such as resiquimod, may stimulate the immune system in different ways and stop     tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and     resiquimod are more effective when given together or separately   "
117364|NCT01749839|"     Past PRP therapy is not sufficient for some part of patients.In this clinical research, The     integrated application of PRP with extracellurar matrix and some type of stem cell technique.   "
117365|NCT01749826|"     The PI is interested in learning how the immune system and the inflammation process is     effected by acute and chronic opioid exposure. Preliminary evidence in animal models show     that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid     exposure causes increased inflammatory responses, as measured by local cytokine release at     the site of injury. Translating these findings to humans will lead to important new     mechanistic knowledge that may ultimately improve our ability to treat pain.   "
117366|NCT01749813|"     This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical     remission in pediatric and adult patients with Crohn's disease.   "
117367|NCT01749800|"     The overall goal of the proposed project is to perform a preliminary study to assess the     potential effects of galvanic vestibular stimulation (GVS) on the outcomes of a cognitive     test of attention and the outcomes of robot-assisted upper-limb rehabilitation.   "
117397|NCT01749410|"     This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA     in Chronic Migraine patients who have received a minimum of 7 treatment cycles.   "
117368|NCT01749787|"     The purpose of this study is to determine the safety and tolerability of PRTX-100 when     various doses are given 5 times at weekly intervals to patients with active rheumatoid     arthritis that are taking methotrexate or leflunomide. The drug is administered in a     physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid     arthritis by suppressing the immune responses.      PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this     study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100.     There will be an inactive placebo cohort for comparison. Patients who do not attain low RA     disease activity, by a commonly used measure, will leave the study at 3 months after their     first dose of study drug.   "
117369|NCT01749774|"     The purpose of this study is to determine the feasibility and effect of a program including     information, counseling and an individualized physical activity program on physical and     psychological health during and after chemotherapy in patients with testicular cancer. It is     hypothesized that the patients are able to complete the intervention with individual     adjustments.   "
117370|NCT01749761|"     It is very common for hemodialysis patients to have problems with low blood pressure while on     hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an     increased risk of death and hospitalizations. It might be possible to minimize or even     prevent these low blood pressure episodes with a software that can be added to the dialysis     machine which detects the patient's changes in blood pressure and automatically slows down     how much fluid is being removed from the person.      The investigators hypothesize that a blood pressure guided biofeedback system (called     BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on     hemodialysis.   "
117371|NCT01749748|"     To delineate if the chemical composition (lipid and water) in the presumably normal breast of     the high risk women is different from those of the low risk group.   "
117372|NCT01749735|"     The aim of this study is to compare the effect of transcranial direct current stimulation and     functional upper extremity task training to functional upper extremity task training alone.     The functional upper extremity task training uses the Armeo Spring robotic arm to support the     limb while playing functional task games on a computer.      Specific Aims:        1. To demonstrate that tDCS combined with upper extremity functional task training in a          virtual environment is more effective than functional task training in a virtual          environment with sham tDCS.        2. To compare cortico-excitatory changes following training with tDCS vs. sham stimulation,          using paired- and single-pulse transcranial magnetic stimulation as a tool to measure          cortical excitability.   "
117373|NCT01749722|"     To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy   "
117389|NCT01749514|"     The purpose of this study is to evaluate the effects of ACE-536 on anemia in patients with     low or intermediate-1 risk MDS.   "
117374|NCT01749709|"     Clinical study including 60 subjects to investigate the effect of daily music listening on     stress parameters during the acute phase of stroke and on recovery. 20 subjects listen to     instrumentala music, 20 listen to music with lyrics and 20 are controls. Outcome measures in     the acute phase are levels of physiological stress parameters (cortisol, endorphin,     oxytocin). Outcome measures in the recovery phase are cognitive capabilities and mood     measured with standard clinical tests. Follow-up time is 6 months.   "
117375|NCT01749696|"     The aim of our study is to investigate the alterations in connective tissue of vaginal wall     in patients with and without pelvic organ prolapse (POP).   "
117376|NCT01749683|"     The goal of this study is to use MCE (myocardial contrast/perfusion echocardiography) to     study and compare short/long term change of myocardial perfusion abnormality and cardiac     outcome in diabetic patients after nonfatal MI (heart attack), who are treated with different     glucose control agents.   "
117377|NCT01749670|"     There is accumulating evidence that genetic expression plays a role in autism spectrum     disorder, but the regulation of such genes is poorly understood. Small RNA particles, called     microRNA (miRNA), have the ability to alter gene expression. These particles can be packaged     and released from brain cells into the blood. Changes in miRNA may contribute to the patterns     observed in autism spectrum disorder.      The purpose of this study is to identify small RNA particles that regulate gene expression in     autism spectrum disorder. The goal is to identify miRNA expression patterns which may improve     our understanding and diagnosis of autism spectrum disorder.   "
117378|NCT01749657|"     The lack of high quality evidence to guide conservative care for patients with posterior     tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic     devices are available to avoid a costly and debilitating surgery but no consensus on which to     use has been made. The current study aims to link biomechanical testing of selected devices     to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.   "
117379|NCT01749644|"     Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis     (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to     eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin     which is given every other month.. Inhalation of Tobramycin was proven as an effective     treatment that improves the respiratory function and reduces the concentration of bacteria in     the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and     therefore adherence is a major problem. The effect of switching from inhalation treatment to     inhaler treatment on patient's adherence and quality of life has not been studied.   "
117380|NCT01749631|"     The purpose of this study was to record the effectiveness of sevoflurane for intubation in     Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards     to the rate of intubation success.   "
117381|NCT01749618|"     Rheumatologists treating patients with seronegative arthritis will be randomized to treat     their patients to a target or to treat their patients under their usual standard of care. All     physicians will perform an initial chart audit. Following the initial chart audit, all     physicians in the treat-to-target group will receive accredited educational training. Six     months after the initial chart audit, all physicians will perform a repeat audit to see if     patients are assessed more systematically and treated to a target of low disease state.   "
117382|NCT01749605|"     Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of     nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.   "
117383|NCT01749592|"     -  As the left and right hemisphere are specialized for different auditory tasks, the          proposed study aims at demonstrating different consequences of right or left-sided          deafness for the affected individual.        -  Furthermore, the question should be answered if auditory deficits and plastic changes          can be partially reversed by cochlear implantation of the deaf ear.        -  Multicenter, prospective, open, non-randomized clinical trial with 5 patients with          right-sided and 5 patients with left-sided sensineural deafness.        -  Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG        -  Comparison of pre-operative investigations with 10 healthy subjects (age and gender          matched control group)        -  Cochlea implantation        -  Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization          Audiometry, PET, EEG, Questionnaires        -  Trial with medical device   "
117384|NCT01749579|"     Sixty patients who refer to the emergency ward and need any painful procedure in the ward are     randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl     and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will     be compared regarding recovery time and other parameters described below.   "
117385|NCT01749566|"     Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV medicines are used     by a person before they are exposed to HIV in order to decrease his or her chance of getting     infected. In this study, we will investigate a new PrEP strategy in women using a drug called     maraviroc, a medicine used in the treatment of HIV infection called a CCR5 antagonist. We     hypothesize that maraviroc could be a particularly good drug for PrEP because it achieves     high concentrations in the genital tract in women and decreases the number of HIV-susceptible     cells in the genital tract, and thus could potentially be dosed in more favorable ways than     the current PrEP drugs.      In order to further evaluate this PrEP strategy, we plan to measure the amount of maraviroc     in the blood and genital tract of HIV-negative healthy female volunteers before, during, and     after they are given maraviroc dosed either in the standard (twice a day) or reduced (once a     day) dose for 7 days compared with women who are not given maraviroc. We will also study     immune cells from the blood and genital tract from these women to see if maravoric has an     effect on these cells that would prevent them from becoming infected with HIV.   "
117386|NCT01749553|"     To Determine whether an eight-week posterior shoulder stretch was effective in increasing     dominant arm internal rotation(IR) and horizontal adduction (HAd) range of motion (ROM) in a     group of overhead athletes identified as having tightness of their posterior shoulder     structures.   "
117387|NCT01749540|"     The purpose of this study is to evaluate the effects of ACE-536 in patients with     beta-thalassemia.   "
117388|NCT01749527|"     We hypothesised that in women with stress urinary incontinence, the severity of leakage on a     24 hour pad test was affected by activity.   "
117390|NCT01749501|"     Those infants who received the muscle relaxation in combination with the vagolytic (reduce     vagus nerve impulses) and pain medication will have reduced time to successful intubation     (placement of tube into the lungs), a decrease in the number of attempts, and better     intubation conditions reported by the practitioner. The objectives of the study include: 1.)     Does the medication protocol outlined in this study provide optimal intubation conditions?     (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.)     Does the addition of a muscle relaxant prior to intubation contribute to less attempts and     achieving successful intubation as opposed to neonates who do not receive the muscle     relaxant.   "
117391|NCT01749488|"     The main objective of this study is to evaluate the impact of the intervention of a dietician     on the energy balance accumulated over seven days of intensive care.      Energy balance is defined as the difference between the target recommended energy and total     calorie intake actually received.      This is a randomized-cluster study; participating centers are randomized into experimental     and control groups.   "
117392|NCT01749475|"     Most of the reports on hypnosis in the literature have focused on pain control during minor     operations. With this study we aimed to evaluate the role of hypnosis on sedation for     transesophageal echocardiography and compare it with commonly used sedative midazolam.   "
117393|NCT01749462|"     The purpose of the investigation is to confirm the ADR development and the contributing     factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9     mcg Turbuhaler.   "
117394|NCT01749449|"     The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15%     vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial     thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%;     28days) in overweight individuals. We hypothesize that HP will elicit more favorable body     composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of     change will be greatest in those consuming HP meals more frequently.   "
117395|NCT01749436|"     General anesthesia results in the development of atelectasis in the dependent areas of the     lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures,     pneumoperitoneum increases already present atelectasis.      Several methods have been suggested to reduce the impact of atelectasis during surgery.     However, few intraoperative modalities for the diagnosis and monitoring of atelectasis are     available. Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and     easy to use tool that as yet to be studied in the intraoperative setting.      This observational study will aim to clarify the role of lung ultrasound imaging during     laparoscopic surgery for the diagnostic and monitoring of atelectasis.      This study is designed to:        -  Demonstrate a link between the lung ultrasound aeration score, the partial pressure of          oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) ratio and the          oxygenation index.        -  In the event of intraoperative desaturation, study the impact of positive end-expiratory          pressure (PEEP) and/or increase of FiO2 on the aeration score.        -  Study the impact of pain on diaphragmatic function and the aeration score.      Our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes     associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia     and changes occurring during the stay in the recovery room.   "
117396|NCT01749423|"     This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in     patients with Chronic Migraine.   "
117398|NCT01749397|"     This phase I trial studies the side effects and best dose of veliparib when given together     with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or     fallopian tube cancer that has spread to other places in the body. Veliparib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving veliparib together with floxuridine may kill more tumor cells.   "
117399|NCT01749384|"     This phase I trial studies the side effects of and best dose of tivantinib when given     together with bevacizumab in treating patients with solid tumors that have spread to other     areas of the body or cannot be removed by surgery. Tivantinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab     may also stop the growth of cancer by blocking blood flow to the tumor. Giving tivantinib     together with bevacizumab may work better in treating tumor cells.   "
117400|NCT01749371|"     A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E     short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn     injury and, in the process, decrease the secondary consequences of burn injury, including     lung injury and impaired wound healing. This may improve the quality of life of the burn     patient by preventing pathophysiology that may result from oxidative stress and may reduce     hospital stay. Our research will lay the foundation for the future development of effective,     safe, and economic therapeutic interventions to treat burn injury-associated metabolic     abnormalities. Also, it will provide the basis for the development of supplemental     regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very     reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a     simple vitamin that is abundant and approved for clinical use, and b) the subjects will be     monitored consistently for the minimal increased tendency to bleed.   "
117401|NCT01749358|"     This study is about rehabilitation of arm function after a stroke. The investigators are     testing the dosage of therapy that is needed for meaningful recovery of arm and hand     function. Dosage of therapy refers to the amount of time (in this case, the total number of     hours) that a person participates in treatment. The investigators hope to learn how much     therapy time is needed in order for change to occur in arm and hand function after a person     has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or     hand at least 6 months ago.   "
117402|NCT01749345|"     This is a cross-sectional study of six hundred adults with type 2 diabetes, (300 White and     300 African-American) who will be recruited from two primary care sites to determine how     social determinants of health impact diabetes outcomes. The first aim is to investigate the     role of psychosocial factors and SES on diabetes care processes and outcomes. The second aim     is to investigate the influence of community and neighborhood characteristics on diabetes     care processes and outcomes. Finally, we will examine the contribution of social determinants     of health to ethnic differences in diabetes care processes and outcomes. Clinical and     metabolic measures will be abstracted from the electronic medical records. Outcome variables     include hemoglobin A1c, blood pressure, LDL-Cholesterol and quality of life.   "
117403|NCT01749332|"     The purpose of this study is to draw blood from vessels near the liver in patients undergoing     liver surgery. This will be performed in both patients with cancer in order to learn more     about circulating tumor cells, proteins and DNA mutations in the blood.      The blood in patients with colorectal cancer with liver metastases will be compared to blood     taken from patients that do not have cancer that do not have cancer.      Inclusion of patients with benign pathology will allow for the establishment of normal     values which currently do not exist. We will then study whether tumor mutations can be used     to predict recurrence and survival patterns.   "
117404|NCT01749319|"     The primary objective of this study is to characterize baclofen pharmacokinetics following     oral and intravenous administration in patients who are on chronic oral baclofen therapy. The     secondary objective is to determine the safety profile of an IV baclofen formulation.      This study is a randomized crossover study with two treatment arms. All subjects will receive     a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or     intravenous form is given on the first study day will be randomized in a 1:1 manner.      The pharmacokinetic and tolerability information gained from this study will support the     development of further studies to assess the use of IV baclofen to prevent or treat baclofen     withdrawal syndrome.   "
117405|NCT01749306|"     The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment     of patients with epidermolysis bullosa who have wounds that are not healing.      It is hypothesized that ABH001 may initiate and continue wound healing in patients with     epidermolysis bullosa.   "
117406|NCT01749293|"     Allogeneic stem cell transplantation is a potentially curative treatment for patients with     many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of     relapse). This process requires a suitable donor. The best case scenario involves an Human     Leukocyte Antigen (HLA) matched sibling donor. However, this type of donor is not always     available. Donor registries can provide another source for matched unrelated donors, but this     may take valuable time delaying treatment for the transplant recipient. Donor availability     remains a significant barrier to the use of allogeneic (from a donor) stem cell transplant.     This issue disproportionately affects patients of minority backgrounds. Novel strategies to     improve outcomes using alternative donors are desperately needed.      Haploidentical transplants are an alternative which provides a readily available donor in the     form of a partially HLA matched family member. This provides for more potential donors and     the donors can be selected based on other factors that can play a role in transplant success     (e.g. age, gender, KIR alloreactivity). Recent advances in transplant techniques have greatly     improved success rates with haploidentical transplants although disease relapse has remained     as issue.      This trial aims to provide an alternative transplant option for patients with hematologic     malignancies who require bone marrow transplantation but lack an HLA identical donor. The     investigational component of this study is the combination of the Fludarabine/ Busulfan/     Total Body Irradiation conditioning regimen and the HLA Haploidentical Transplant with     post-transplant Cyclophosphamide.   "
117407|NCT01749280|"     The aorta is the main blood vessel that comes out of the heart and distributes blood to the     whole body. In some people, the aorta becomes swollen (aneurysm) and bursts, especially as it     passes through the abdomen. These 'abdominal aortic aneurysms' often occur without symptoms     and can burst or rupture without warning. This usually leads to death and represents the     thirteenth commonest cause of death in the United Kingdom. In this study, we are looking at a     new technique that can look at the aortic aneurysm using magnetic resonance imaging; a     technique that does not require x-rays or radiation. We have recently shown that, using     magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots' of     activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are     therefore potentially at risk of rupture. We here propose to conduct a study in Edinburgh     that will invite all patients who are under surveillance because of an aneurysm. We will     image these patients using this novel technique and see if we can identify which patients     burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die.     This will be important to establish as it will potentially lead to a new way of managing     people that could ultimately save lives. This is particularly timely as national screening     and surveillance programmes are currently being launched.   "
117408|NCT01749267|"     The objective of this study was to analyze the radiographic density of digital subtraction     radiographs after SMART restoration with partial caries removal in primary molars at 6 and 12     months.   "
117409|NCT01749254|"     Cardiovascular disease is the leading cause of death in Scotland and the Western World.     Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic     plaques are urgently needed to help risk stratification, to identify patients for intensive     therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug     interventions. Using positron emission tomography, we have recently shown that sodium     18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and rupture.     Here we wish to characterise coronary atherosclerotic plaque using 128-multidetector computed     tomography combined with 18-fluorodeoxyglucose and sodium 18-fluoride positron emission     tomography and Virtual histology-intravascular ultrasound in 80 patients with stable and     unstable coronary artery disease. This has the potential to provide an innovative and highly     valuable translational model with which to test novel therapeutic interventions targeted at     reducing atheroma and plaque rupture. This could have major implications for the future     treatment of cardiovascular disease.   "
117410|NCT01749241|"     Inflammation occurs after any type of incisional surgery. This study will evaluate the     efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative     inflammation after routine eyelid surgery.   "
117414|NCT01749189|"     This study will investigate the effects of a soy/dairy protein blend on muscle growth and     strength. In sports nutrition and in aging it is important to have healthy muscles. This can     be achieved with exercise and nutrition. Consumption of protein following resistance exercise     can promote healthy muscle growth and help improve strength. Young healthy men will be     studied during a 12 week resistance exercise training program and be given protein     supplements every day during the study. The hypothesis is that a blend of soy, whey and     casein will induce a greater muscle gain and strength increase than the control.   "
117415|NCT01749176|"     Randomized controlled trial testing the efficacy of a text messaging intervention in a low     income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will address     barriers to participation in health education classes, increasing adherence to treatment and     medications and improving diabetes self management behaviors and skills. Two community clinic     organizations that provide services to a large proportion of Latino patients with type 2     diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes     management care (control) only or text messaging and standard care. Comparisons between     groups will evaluate clinical, behavioral and psychosocial outcomes.      Intervention: Standard Care and Text Messaging. All participants will receive standard     diabetes care provided by primary care providers at the clinic. Of the 100 that are     randomized to the intervention arm will be given instructions on how the text messaging     component will be addressed throughout the duration of the study.   "
117416|NCT01749163|"     Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion     augment insulin secretion from the pancreas to help maintain glycemic control. Studies in     vitro and in vivo have shown that these incretin hormones also have functional effects in     other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate     insulin secretion in a glucose-dependent manner, however the glucose-dependency of their     extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp methodology     during euglycemic and hyperglycemic conditions we will test the hypothesis that     extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.   "
117417|NCT01749150|"     This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability,     pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with     Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian     origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus     ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys     180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment     duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated     cirrhosis.   "
117418|NCT01749137|"     The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight     loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and     ambulatory blood pressure in obese patients. The study is designed to evaluate the efficacy     and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo) will be     administered subcutaneously in a blinded fashion.   "
117419|NCT01749124|"     This is a pilot study for a novel, automated telephone system called My Coach Connect. The     purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool     while engaging clients and providers in discussion groups and surveys to better understand     how this tool impacts the care provided and their overall experience in healthcare.   "
117420|NCT01749111|"     The purpose of this study is to determine whether cyclophosphamide post bone marrow     transplant increases the rate of patients alive, in remission and without immunosuppression,     one year after transplant, when compared with the combination of methotrexate and calcineurin     inhibitor   "
117423|NCT01749072|"     In the National Comprehensive Cancer Network (NCCN) guideline for NSCLC, epidermal growth     factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is recommended as the third-line     treatment for EGFR gene mutation negative NSCLC patients who failed to the first-line     platinum doublet chemotherapy [i.e. paclitaxel-carboplatin (PC) or gemcitabine-cisplatin     (GP)] and the second-line chemotherapy with docetaxel or pemetrexed. But as we know, if     patients had no EGFR gene mutation, EGFR-TKI treatment is not effective. The overall survival     is short and the objective response rate is low. As for EGFR gene wild type patients with     good performance status, besides EGFR-TKI treatment, other first generation cytotoxic drugs     i.e. vinorelbine or ifosfamide maybe an alternative treatment. So the purpose of this     clinical trial is to compare the effectiveness and safety of vinorelbine-ifosfamide with     gefitinib in advanced or metastatic EGFR gene mutation negative NSCLC patients.   "
117424|NCT01749059|"     The purpose of this study is to evaluate the impact of implementing a universal pulse     oximeter screening as a way to detect critical congenital heart disease in otherwise     well-appearing newborns.   "
117425|NCT01749046|"     The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is     effictive and safe in patients with epilepsy with partial seizures   "
117453|NCT01748552|"     The aim of this trial is to evaluate the safety of the study drug in healthy participants and     participants with diabetes. It will investigate how much of the study drug gets into the     blood stream and how long it takes the body to get rid of it. Information about any side     effects that may occur will also be collected.      The study consists of two parts. Part A will study healthy participants in up to 3 dosing     periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3     dosing periods over approximately 6 weeks.   "
117454|NCT01748539|"     This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with     moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled,     parallel group study. Pharmacokinetics of KHK4827 will also be assessed.   "
117455|NCT01748526|"     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the     drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of     canagliflozin (JNJ-28431754) in healthy Indian volunteers.   "
117426|NCT01749033|"     A laryngeal mask airway (LMA) is an airway device that is commonly used and placed under     general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is     similar to an endotracheal tube (a breathing tube) but is less invasive. It is also placed     as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is     not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those     of breathing tube placement, such as sore throat and hoarse voice. Previous studies have     examined several variables that may affect how often complications occur; these variables     include giving anti-inflammatory medications and inflating the LMA to different pressures     (the working end of the LMA, which rests in the patient's throat, has a cuff that is     inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on     postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3     placement techniques - the traditional placement technique, a slightly different traditional     placement technique, and a new technique, abbreviated the ELLIA method. The hypothesis of     this study is that a new LMA insertion technique will have no difference in postoperative     pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.   "
117427|NCT01749020|"     The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on     insulin sensitivity in normal weight and overweight adults.   "
117428|NCT01749007|"     The purpose of this project is to gather pilot data related to exploring relationships     between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or     behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency     Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to     Veterans with HIV/AIDS.   "
117429|NCT01748994|"     The body shape of obese women varies between having the majority of fat either above the     waist (apple shape) or below the waist (pear shape). The study will investigate what     restricts: apple-shaped women from being pear-shaped at the cellular level. Since pear     shaped women tend to have better health, this study will open the door to future research in     regulating body shape and thus improving health.   "
117430|NCT01748981|"     The purpose of the study is to investigate the change in pulmonary function and exercise     capacity in lung cancer patients after pulmonary resection. Furthermore, to study the effect     of training on aerobic capacity, muscular strength, morbidity and survival. Physical activity     level by accelerometers, body composition by DXA and quality of life will also be reported.   "
117431|NCT01748968|"     The purpose of this project is to gather pilot data related to risk factors associated with     suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency     Syndrome (AIDS) and to develop an educational and interventional tool and instructional guide     that can be utilized by local and national providers to increase understanding regarding     suicide risk assessment. There are no hypotheses associated with this qualitative pilot     study.   "
117432|NCT01748955|"     This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of     two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward processing     in depressed patients who have attempted suicide or are currently experiencing suicidal     thoughts.   "
117433|NCT01748942|"     This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry     mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain     and dry mouth caused by surgery.   "
117434|NCT01748929|"     Women of reproductive age are considered a high-risk group for worm infections by the World     Health Organization. Maternal infection and anemia contribute to infant malnutrition by     affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no     study has investigated the health benefits of postpartum deworming to infants or mothers. A     randomized controlled trial will be conducted in Peru to investigate the effectiveness of     integrating deworming into routine postpartum care. The primary measure of effect will be     infant weight gain between birth and six months of age. Other infant and maternal health     indicators will also be ascertained.   "
117435|NCT01748916|"     The goal of this study is to determine if papaya fruits are an exceptionally good food source     for carotenoids in humans, particularly when compared more common carotenoid sources like     carrots and tomatoes. This objective will be accomplished by quantitation of the immediate     post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from     subjects who consumed a meal containing fresh papaya, tomato, and carrot.   "
117436|NCT01748903|"     The purpose of this prospective registry is to collect real world, post-marketing data on the     use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the     embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients     (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial     aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc     analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be     performed.   "
117437|NCT01748890|"     Prostate cancer is the most common cancer and the second-leading cause of cancer death     amongst men in the United States. Sonoelastography is an imaging technology predicated on     reproducible differences in the backscattered ultrasound signal produced by compression of     tissues of varying stiffness. It permits measurement of the elastic properties of tissue.     These measurements can be transposed onto conventional anatomic ultrasound images, producing     a colorized overlay that allows direct visualization of the anatomic distribution of tissue     stiffness. In this study, we aim to determine whether prostate biopsies planned with     sonoelastographic guidance would be more likely than random prostate biopsies to intersect     with foci of carcinoma in the prostate gland, and to determine whether prostate biopsies     planned with sonoelastographic guidance would be more likely than random prostate biopsies to     yield histopathology representative of the final Gleason Score obtained at pathologic     assessment of the resected prostate.   "
117438|NCT01748877|"     The purpose of this study is to investigate whether NXN-462, a selective nNOS inhibitor, is     effective in reducing pain levels in patients with post-herpetic neuralgia.   "
117501|NCT01747928|"     Usability testing of the dual-chambered syringe in conjunction with the proposed patient     instructions for use.   "
131917|NCT01558531|"     The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty     followed versus conventional balloon angioplasty in superficial femoral artery and popliteal     artery re-stenosis.   "
117441|NCT01748708|"     Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression that     is resistant to common modalities of treatment, such as antidepressant medication. Although     treatment with ECT has benefited many individuals with treatment resistant depression (rates     as high as 50-75%), its more widespread use is hindered by the social stigma associated with     the treatment, as well as by its significant cognitive side effects. Moreover, ECT cannot be     precisely targeted, since it produces a widespread activation of the brain surface, in turn,     affecting many different functional areas. Magnetic seizure therapy (MST) is currently being     investigated as an alternative to ECT, as it is more focused to one area of the brain. Rather     than applying electrical stimuli to induce a seizure, as is done in ECT, MST uses repetitive     magnetic stimulation to produce the seizure. Preliminary research suggests that MST can     result in therapeutic effects comparable to those produced by ECT, but without the negative     side effects on cognition. The proposed study is a randomized, controlled trial, in which the     efficacy and side effect profile of MST will be compared to those of ECT. If successful, the     results of this study may lead to increased treatment availability and accessibility, as well     as lessen the substantial health care costs associated with treatment resistant depression.   "
117442|NCT01748695|"     The purpose of this study is to investigate whether V158866 is safe and effective for the     treatment of neuropathic pain due to spinal cord injury.   "
117443|NCT01748682|"     Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the     reduction of comorbidities associated with surgical act, such as decreased visceral fat,     liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to     be employed in this period need to be defined more clearly. As there is no description of     comparative studies on diet of normal consistency, using solids and liquids, there are doubts     as to the real need for consistency liquid diet in preoperative bariatric surgery. The lack     of robust evidence has made nutrition professionals adopt different procedures. There is     still a belief that these patients are unable to lose weight in the preoperative period, the     ongoing history of previous attempts without success.   "
117444|NCT01748669|"     Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with     garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic     load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls     and healthy volunteers will be included for comparison.   "
117445|NCT01748656|"     Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive     positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of     automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a     pre-determined ideal tidal volume or ideal ventilation. However algorithms used to     achieve these ideal targets are different among different commercialized devices and the     relative efficacy from an algorithm compared to another remains unknown. The main objective     is this study is to compare two commercialized NIPPV that have this option   "
117446|NCT01748643|"     The purpose of this study is to investigate if a deep neuromuscular block with a continuous     infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with     reversal of neuromuscular blockade with sugammadex results in improved surgical conditions     for the surgeon and/or improved post-operative respiratory function for the patients as     compared to a standard technique with an intubation dose of rocuronium and top-ups as needed     to maintain a neuromuscular blockade with a train of four (TOF) count of 1-2 and reversal of     neuromuscular blockade with neostigmine/glycopyrrolate.      Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium     and reversal with sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.   "
117540|NCT01747421|"     In Emergency Departments patients admitted with chest pain may suffer from non-significant to     lifethreatening conditions.      The aim of the present study is to develop and validate a referral model in chest pain     patients which divide the patients with non- significant ECG changes into high risk and low     risk groups for acute coronary syndrome.   "
117447|NCT01748630|"     Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam for     sedation during the early postoperative period in children who underwent scoliosis surgery.      Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a     tertiary care center. In this study, 42 patients (American Society of Anesthesiology physical     status I and II) who underwent scoliosis surgery were divided into 2 groups according to     sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18 years)     requiring mechanical ventilation underwent a continuous infusion of either dexmedetomidine     (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ; starting dose, 0.1     mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of sedation was assessed     using the Richmond Agitation Sedation Scale (RASS). Quality of pain relief was measured using     the Numeric Visual Analog Scale (NVAS). During the arousal assessment, delirium was     determined in patients in the RASS range of -2 to +1 using the Confusion Assessment Method     for the ICU (CAM-ICU). Fentanyl consumption, incidence of delirium, NVAS scores, and     hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h in the ICU.   "
117448|NCT01748617|"     This study will be a randomized, double-blind, crossover intervention to investigate the     health effects of acute ingestion of pomegranate juice when consumed with a high fat meal.     After one week of controlled dietary intervention, subjects will consume a high fat morning     meal supplemented with either pomegranate juice or a juice-free sweetened beverage. After     consumption of the breakfast meal, subjects will be assessed for endothelial function and     postprandial meal response.   "
117449|NCT01748604|"     The purpose of this multicenter randomised controlled study is to determine whether manual     lymphatic drainage (MLD) brings any benefit when added to intermittent pneumatic compression     (IPC) plus multilayer, multicomponent bandages (MB) in the decongestive lymphatic therapy     (DLT) in patients with lymphedema   "
117450|NCT01748591|"     A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.   "
117451|NCT01748578|"     This is a First-In-Human (FIH) study to assess the safety and tolerability of ocular     administration of EBI-005 in healthy volunteers. Additionally, the PK and immunogenicity of     EBI-005 will be assessed.   "
117452|NCT01748565|"     The purpose of this study is to identify biological markers that might predict premature     infants who are at a higher risk for developing BPD, and to correlate the presence of these     markers with infant symptoms and lung function in the first year after discharge from the     hospital.   "
117528|NCT01747577|"     The purpose of this study is to demonstrate superiority of the solifenacin succinate     (treatment) over the placebo (control) based on the change from the baseline in the mean     number of urgency episodes per 24 hours after 2 weeks.   "
117456|NCT01748513|"     Preoperative venous return stability and euvolemia is essential in management of morbidly     obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on     preoperative management, are rare and not in consensus.The aim of this study was to evaluate     preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on     hemodynamics, stroke volume and level of venous return to the heart.   "
117457|NCT01748500|"     The main objectives of this trial are:        1. To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men          with metastatic CRPC who have not received prior chemotherapy.        2. To evaluate archival prostate cancer tissue of men included in the clinical trial for          evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG.        3. To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.   "
117458|NCT01748487|"     The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone     intravitreal implant) 0.7 mg administered immediately after phacoemulsification and     intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of     post-surgical macular edema (ME).      Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of     cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the     same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit     4).      BCVA, IOP and SD-OCT will be performed at each visit.   "
117459|NCT01748474|"     In a randomized, sham-controlled trial the investigators will test whether supplemental     oxygen given during cardiopulmonary exercise testing will improve exercise performance and     physiological parameters in patients with pulmonary arterial or chronic thromboembolic     pulmonary hypertension.   "
117460|NCT01748461|"     The purpose of the present study is to evaluate the short-term and long-term effects of a     cycle ergometer program on physical activity and physical fitness in elderly (65+).     Therefore, physical activity, physical fitness and functionality are measured at baseline,     after 10 weeks (after the intervention period), after 6 months and after 1 year.      Different coaching techniques (to promote the use of a cycle ergometer and cycle ergometer     program) will also be evaluated. What is the best (coaching) approach for long-term adherence     (physical activity)?   "
117461|NCT01748448|"     To assess whether vitamin D supplementation after surgery of a first cutaneous malignant     melanoma protects against relapse of the disease.   "
117462|NCT01748435|"     Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of     patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit     protheses and mobilise. Current treatment options are limited and existing painkillers have     significant side effects. Nevertheless there is some evidence that pre-emptive analgesia     (pain relief provided prior to the surgery) has additional benefits after the surgery     (Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is     applied directly onto the skin. It works by desensitising to pain receptors in the skin     (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in     other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for     pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot,     randomised controlled study of 30 patients undergoing lower limb amputation who will have     Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks     post-operatively with regular assessment of pain scores, quality of life and wound healing.   "
117598|NCT01746654|"     The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe     and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis,     (ii) is it effective in reducing the nasal carriage of pathogen (Staphylococcus aureus) in     humans.   "
117463|NCT01748422|"     Arteriovenous fistulae are artificial connections between the artery and vein in the arm     which allow needles to be inserted for haemodialysising patients wit kidney failure.     Occasionally severe debilitating pain can arise from these fistulae for which no cause can be     found. Such pain can be very difficult to treat. Many commonly used used painkillers are     known to cause significant side effects in patients with renal failure (drowsiness, confusion     etc.      Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied     to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.     It therefore should not have the systemic side effects of other drugs. It has been     demonstrated to be beneficial in other painful conditions for example post-shingles pain and     nerve pain from HIV. It has never been used for critical ischaemia before.      We propose to investigate the efficacy of Qutenza in treating patients with end stage renal     failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful     AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change     in their pain scores.   "
117464|NCT01748409|"     The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical,     electrophysiological and neuropathological examination.   "
117465|NCT01748396|"     Chronic kidney disease (CKD) is an established risk factor for cardiovascular morbidity and     mortality, as shown by common manifestations of left ventricular hypertrophy (LVH) and     arterial calcifications in CKD patients. Fibroblast growth factor-23(FGF-23) is a recently     identified phosphaturic hormone that has been reported to be associated with the development     of secondary hyperparathyroidism, cardiovascular morbidity, mortality, CKD progression.      While vitamin D is the mainstay therapy in CKD mineral bone disease (CKD-MBD), increased     FGF-23 levels have been reported with vitamin D administration. The purpose of this study was     to investigate the effect of calcium carbonate when used in conjunction with calcitriol on     FGF-23.   "
117466|NCT01748383|"     The purpose of this study is to test the hypothesis that the intracoronary transplantation of     autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular     contractile function and will reduce the combined end points after the primary STEMI     (mortality, recurrent myocardial infarction, angina, heart failure, stroke).   "
117467|NCT01748370|"     Low total testosterone (TT) is present in about 30% of men aged >60 years and in up to 7% of     younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as     well as with increased mortality. There is evidence showing a relationship of TT with vitamin     D in men. We aim at evaluating the effect of vitamin D supplementation on TT and metabolic     parameters in hypogonadal men. We will study the effects of 20,000 IU vitamin D weekly in a     12 wk randomized, double-blind, placebo-controlled trial in 100 men with TT <3.0 ng/ml and     25-hydroxyvitamin D (25(OH)D) <30 ng/ml (patients) as well as in 100 men with TT ≥3.0 ng/ml     and 25(OH)D <30 ng/ml (controls). Vitamin D supplementation might be a safe therapeutic     approach improving TT levels as well as metabolic parameters in hypogonadal men. Further the     effects of vitamin D on androgens will be evaluated in eugonadal men.   "
117468|NCT01748357|"     Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.     Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis     require advanced and expensive diagnostic methods that restrict their availability in     resource limited countries where the burden of tuberculosis is highest. The development of     rapid point of care diagnostics is required.      Published data confirm that trained African giant-pouched rats are able to identify M.     tuberculosis cultures through olfactory recognition. A first trial using an electronic nose     reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in     June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the     recognition of tuberculosis remains unknown.      This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a     potential for further development and fine tuning. A technical prototypic device of Siemens     is used for pattern detection.      The study is comparing 3 groups of patients:        -  patients with confirmed active pulmonary tuberculosis (n=20)        -  patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial          carcinoma) (n=20)        -  healthy volunteers that do not work in the hospital or visit the hospital regularly          Detailed data for all study subjects will be collected for this trial in order to          eliminate confounding factors. Furthermore, detailed data of the surroundings of the          patient, the surroundings of the technical device and of the operator will be captured.      Hypothesis:      The pattern of exhaled volatile organic compounds allows the detection of pulmonary     tuberculosis   "
117469|NCT01748344|"     The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic     rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled     conditions.   "
117470|NCT01748331|"     The purpose of this study is to determine the effect of fluid restriction and the     neurohormonal mechanisms in the development of hyponatremia in patients with congestive heart     failure and hyponatremia. The hypothesis is that strict fluid restriction leads to a larger     increase in plasma sodium than standard treatment in patients with decompensated heart     failure associated with hyponatremia. A secondary hypothesis is that the neurohormonal change     is greater in patients treated with strict fluid restriction versus standard treatment.   "
117471|NCT01748318|"     In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative     that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be     evaluating the effectiveness of a locally produced New Mexico Honey against the standard of     care Bactrim antibiotic on Community Acquired MRSA.   "
117472|NCT01748305|"     Patients with newly diagnosed gestational diabetes will be recruited. The control group with     get routine diet and exercise counseling. The intervention group will be instructed to get     moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with     supervision in order to be instructed how hard to work. All participants will keep an     exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is     glucose control, specifically the need for medication in treatment of their diabetes. The     hypothesis is that moderate or greater intensity exercise will better control glucose and     lead to less need for medication management.   "
117599|NCT01746641|"     The purpose of this study was to compare remifentanil and propofol for sedation of patients     during endoscopic gastrointestinal procedures.   "
117473|NCT01748292|"     TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be     randomized 1:2 to monthly (control arm) or treat and extend protocol (comparator arm)     respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections     (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN)     treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients with     wet age-related macular degeneration (AMD). Subjects treated in a treat and extend protocol     receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week 8, if a     subject has achieved a dry macula; signs of active exudation have resolved will begin a     Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry macular is     maintained). At the beginning of the 104-week endpoint subjects initially randomized to the     TREX cohort will transition to PRN re-treatment when there is no exudative disease activity     at the 12-week interval.   "
117474|NCT01748279|"     Rationale: Retrospective studies suggest that statins improve outcomes in COPD patients     possibly as a result of an anti-inflammatory effect.      Objectives: To determine whether statins have an anti-inflammatory effect on the lungs of     patients with COPD.      A controlled, parallel group study to compare the effects of Atorvastatin in comparison to     placebo as an add-on treatment to Formoterol therapy in patients with mild to moderate COPD     in group of 20 patients. All subjects will have spirometry, lung volumes, DLCO, SGRQ, 6MWD,     serum lipids and hs-CRP measured before and after treatment. Bronchoscopy and transbronchial     lung biopsy (TBB) will be carried out at baseline and after 12 weeks of treatment, and TBB     specimens will be processed for histology, immunohistochemistry and microarray analysis.   "
117475|NCT01748266|"     Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB)     have been thought to be at the origin of organ dysfunction. Though, few studies correlated     microvascular alterations with outcome. Investigators aimed at firstly describing     microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS     parameters with intensive care length of stay and organ dysfunction.   "
117476|NCT01748253|"     Evaluation of 24-hour antihypertensive effect of long-acting ARB-CCB tablet administrated to     hypertensive patients with atrial fibrillation, and comparison of 24-hour antihypertensive     effect of long-acting ARB-CCB tablet between morning administration and bedtime     administration.   "
117477|NCT01748240|"     Azacytidine (AZA) is the current standard of care for frontline patient treated with     high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will     never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS     and proven in vitro synergy with AZA. Patient treated upfront with a combination of this     agents have shown more responses based on phase I/II data. In the present study, we will use     the combination of these two drugs to try to create a synergetic effect and generate a     response for patients who experienced treatment failure after AZA.      All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28     days. Study Design   "
117529|NCT01747564|"     The purpose of this study is to evaluate safety and absorption, distribution and elimination     of mirabegron after oral administration to Chinese subjects.   "
117478|NCT01748227|"     The overall purpose of this pilot study is to conduct a formative evaluation of (veteran)peer     delivery of a chronic pain self-management program to veterans with chronic musculoskeletal     pain.      Our specific aims are as follows:      Aim 1: Evaluate the feasibility of identifying, recruiting, training, and retaining veteran     peers to implement a self-management program for chronic pain.      Aim 2: Identify facilitators and barriers to peer-delivery of a chronic pain self-management     program.      Aim 3: Convene an expert panel to review the results of Aims 1 and 2, help to interpret the     results, and plan next steps.   "
117479|NCT01748214|"     Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory     support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal cannula:     >1 L/min flow - HFNC). While there have been small descriptive studies of noise exposure in     infants on NCPAP, there have been no comparative trials done comparing noise exposure in     infants undergoing both NCPAP and HFNC.      Objective: Using a cross-over model determine noise exposure levels in infants exposed to     similar levels of respiratory support provided by NCPAP and HFNC.   "
117480|NCT01748201|"     Hemophilia is a recessive X chromosome linked genetic disorder of blood coagulation that     affects about one in every ten thousand people. Hemarthrosis, which you can begin in     childhood, promptly leads to degenerative changes of the articular cartilage which culminate     in deformity and degenerative changes early, known as hemophilic arthropathy, which is the     most common complication of hemophilia. Aside administration of clotting factor, treatment     should address the degenerative changes already present in patients joints. Our objective is     to evaluate the effectiveness of articular washing followed by infiltration with     corticosteroids and hylan G-F 20, followed by a program of home exercises and/or academy as     the previous level of hemophilia patients, in relation to pain relief, and improved function     and quality of life.   "
117481|NCT01748188|"     The purpose of this study is to determine whether dexketoprofen administered by phonophoresis     or iontophoresis is more effective in the treatment of subacromial syndrome that the     conventional therapy with ultrasounds.   "
117482|NCT01748175|"     The Severe Asthma Research Program III is an NIH cooperative agreement involving 7 clinical     centers that encompass a multidisciplinary partnerships between asthma clinician-scientists     and scientists with expertise in immunology, pulmonary physiology, molecular genetics,     molecular phenotyping, imaging, and bioinformatics. These clinical centers will jointly     recruit volunteers with asthma for an observational longitudinal follow-up study. However,     centers will also conduct specific mechanistic research projects at each participating     institution. The University of Pittsburgh's SARP III study will determine the molecular and     clinical stability of asthma phenotypes over time.   "
117538|NCT01747447|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in     25,874 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study is being conducted among a sub-cohort of 773 participants in     VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs.     placebo on skeletal health and body composition.   "
117483|NCT01748162|"     Presently children who experience recurring croup symptoms receive a variety of treatments.     This is because it is not clear which treatments may be best. Some children are given inhaled     steroids (similar to what children with asthma use). Others are carefully watched and     cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and     should episodes of croup recur they are treated with a short course of oral steroids. The     purpose of our study is to compare two safe and clinically appropriate methods for treating     recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed     basis, to see if either is useful in preventing future episodes of croup.   "
117484|NCT01748149|"     This is a multicenter, safety and pharmacokinetic trial to determine the MTD and/or select a     recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory     gliomas containing the BRAFV600E or BRAF Ins T mutation.   "
117485|NCT01748136|"     That computed tomography (CT) screening of HIV-seropositive heavy smokers will detect early     stage lung cancer at significantly higher rates than what is currently being observed.   "
117486|NCT01748123|"     -  Clinical equipoise exists with respect to the important question, What is the best          initial diuretic for the treatment of Hypertension? A pragmatic comparative          effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide (HCTZ)          could help inform decision making for this common problem.        -  The investigators aim to harness both the power of bioinformatics (using web-based          data-capture and electronic health records) and of online media (through collaboration)          in order to facilitate such a CER in usual-care settings. This process may also          provide a foundation for testing a wealth of important clinical questions which commonly          arise in the delivery of contemporary healthcare and would otherwise be left unanswered.        -  To this end the investigators are developing a website, EBMtrialcentral, where eligible          physicians can go online and join their collaborative network. Physicians can then          enroll eligible patients in this study. These will include under-served urban patients.          Clinical information will be entered online (using a secure database housed at Johns          Hopkins), patient consent will be obtained electronically and treatment recommendations          will be randomly allocated to either 25mg daily of oral HCTZ or 12.5mg daily of oral          Chlorthalidone. The investigators aim to increase to 50mg HCTZ and 25mg Chlorthalidone          over 8 weeks and compare their effects on BP measured with a 24 hour monitor.        -  The investigators' primary hypothesis is that non-blinded, random, parallel allocation          of 12.5mg daily Chlorthalidone (titrated to 25mg at 4 weeks) will demonstrate a          clinically meaningful ≥5mmHg improvement in BP control (as measured by change in BP from          baseline using 24hr ABPM) compared to 25mg daily HCTZ (titrated to 50mg at 4 weeks) in          newly hypertensive patients followed in a usual-care clinic setting over 8 weeks. They          will also analyze differences in side-effects or safety (serum electrolytes) between          these two medications.   "
117487|NCT01748110|"     The goal of the study is to assess the impact of a health intervention, involving both diet     and exercise modification, on outcomes following radical prostatectomy for the treatment of     clinically localized prostate cancer. The specific urological outcomes expected to be     improved are accelerated and/or improved recovery of erectile function (EF), as well as     urinary continence, both very commonly affected by this surgery. Furthermore, as demonstrated     by changes in responses to various questionnaires, an improvement in overall health-related     quality of life is expected. Finally, an improvement in patients participating in the     intervention groups in physical parameters, including body mass index (BMI), blood pressure     (BP), and metabolic parameters, including serum glucose and cholesterol levels, is expected.   "
117488|NCT01748097|"     The investigators use bicarbonate injected to an intravenous line and the changes in the     exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding     tissue   "
117489|NCT01748084|"     The purpose of this study is to determine whether rituximab is effective in the treatment of     articular symptoms that occur in systemic sclerosis related polyarthritis   "
118405|NCT01736137|"     The purpose of this study is to assess functional capacity, quality of life and functioning     of the autonomic nervous system in heart failure patients on beta-blocker treatment. The     study hypothesis is that subjects who walk less distance, have lower quality of life and     reduced heart rate variability during the six minute walk test.   "
117490|NCT01748071|"     Purpose: This study aimed to find a quick and timely way to investigate the individual     variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries.     Methods: 120 female patients receiving elective surgery under general anesthesia were     recruited into this study. At the time of routine intravenous anesthetic induction we observe     the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index,     sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.   "
117491|NCT01748058|"     The aim of this study is to evaluate the efficacy and feasibility of active video gaming with     regard to the promotion of physical activity and motor learning in children with cancer.     Experienced fatigue, body mass index and the development of metabolic risk factors during     treatment are also examined.   "
117492|NCT01748045|"     The aim of this study is to determine if inhaled nitric oxide will improve short and long     term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36     weeks and who require breathing support with high flow nasal cannula, nasal continuous     positive airway pressure, or nasal intermittent positive pressure will be randomized to     receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol     until all respiratory support has been discontinued. Infants will be followed to evaluate     safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.   "
117493|NCT01748032|"     The purpose of this study is to examine the effects of the alternative uses training (AUT)     and word association training (WAT) on cognitive functions and mood symptoms in late-life     depression (LLD).      The hypotheses are:        1. post-training cognitive performance will be superior to pre-training cognitive          performance        2. post-training depressive symptomatology will be less severe as compared with          pre-training clinical severity and        3. AUT group will show better post-training cognitive performance and improved mood          symptoms when compared with the WAT group.   "
117494|NCT01748019|"     ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex,     inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an     increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and     topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor activity     has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I     mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in     camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials.   "
135661|NCT01509079|"     The Purpose of this study is to determine whether vitamin D3 supplements will decrease the     muscle and bone pain that are reported by women who take Aromatase Inhibitors.   "
117495|NCT01748006|"     The relationship between the activation of the vasopressin system and central hemodynamics in     heart failure (including right and left heart filling pressures and cardiac output) is not     clear. The investigators intend to examine the correlation between levels of copeptin and     vasopressin and the central hemodynamic system in patients with advanced (class III or IV)     heart failure. The investigators also aim to examine the relationship of selected cardiac     biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients     with decompensated heart failure.      The study population will consist of 30 patients admitted to the Department of Cardiology at     Copenhagen University Hospital. Only patients for whom the attending cardiologist has already     decided upon right heart catheterization for clinical/treatment reasons will be recruited for     the study.   "
117496|NCT01747993|"     Catheter-associated urinary infections are the most common hospital-acquired infections and     can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the     failure of early catheter removal has been studied in elderly women hospitalized for an acute     condition and experiencing acute urinary retention: 448 women 75-year old or more without an     anatomical or neurological cause of urinary retention will be randomized to a 6 days course     of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of     tamsulosin and the need to replace another catheter within 72 hours will define a failed     attempt.   "
117497|NCT01747980|"     Absorption of therapeutic proteins taken orally has remained the major hurdle for treatment     in humans. The proteins are generally degraded by enzymes in the stomach and intestine and     the intestine lining that prevents absorption into the circulation. Administration of     PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier     vehicle, may help overcome many of these hurdles. The plant cell wall protects the protein     from degradation in its transport through the upper GI and allows release in the lower     intestine. Studies in animals have shown that prGCD delivered in this way can be found in the     blood stream in an active form.   "
117498|NCT01747967|"     There is currently no imaging technique allowing to directly visualize and measure pancreatic     beta-cell mass. Consequently, the best parameter to estimate this mass is the insulin (and     its C-peptide byproduct) that residual beta cells are able to produce. This insulin secretion     is measured during a meal test, before and at different times after drinking a standardized     quantity of nutrients. However, this test is cumbersome (lasting 3 h, with blood samples     taken every 30 minutes) and it holds poor sensitivity, probably insufficient to detect very     few residual beta cells. Nevertheless, these few residual cells can improve glycemic control     and can be instrumental for the clinical efficacy of immune and/or regenerative therapies.      We hypothesize that residual beta cells may not only represent the remaining insulin     secretory capacity, but also the antigenic load capable of stimulating beta-cell-reactive T     lymphocytes. The disappearance of these T lymphocytes from circulating blood over time may     thus be correlated with beta-cell loss. Measuring beta-cell-reactive T-cell responses may     therefore provide simple and sensitive immune surrogate markers of residual insulin     secretion. Other surrogate markers may be obtained by measuring urinary C peptide or residual     secretion of the counter-regulatory hormone glucagon.      The main objectives of this study are:        1. To evaluate the correlation between beta-cell-reactive T-cell responses and residual          insulin secretion.        2. To evaluate the correlation between the residual insulin secretion measured by serum C          peptide and by urinary C peptide.        3. To evaluate the correlation between the residual insulin and glucagon secretion.   "
117499|NCT01747954|"     The hypothesis of this study is that respiratory physiotherapy can promote improvement in     respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is     more effective in improving respiratory mechanics in childrens and does not alter the     hemodynamic proved safe   "
117500|NCT01747941|"     The study is designed to test safety tolerability and PK of single oral ascending doses of     PF-06305591,   "
117502|NCT01747915|"     The study is designed to evaluate the safety, tolerability and efficacy of two doses of     pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized     Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of     pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC     seizure frequency and that pregabalin will be safe and well tolerated.   "
117503|NCT01747902|"     The long head of biceps brachii tendon has been known to be a pain generator and a common     cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps     tenotomy and tenodesis have been shown to produce comparable results, but there is no     consensus to date due to a lack of level I evidence. The aim of this prospective, randomized,     clinical trial is to compare subjective patient-reported outcomes and objective clinical     results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of     the biceps brachii.   "
117504|NCT01747889|"     This study is designed to compare the Thopaz chest tube drainage system to the traditional     collection chamber system. The Thopaz system is already in clinical use in the United States     and throughout the world. As such, this study is not evaluating safety or efficacy of this     system both of which have already been demonstrated. This study's primary aim is to determine     whether the use of a digital chest drainage system compared with a traditional system affects     duration of chest drainage and length of hospital stay.      Furthermore, we aim to determine whether the use of a digital chest drainage system compared     with a traditional system increases the total distance of ambulation in the first 48 hours     after thoracic surgery and affects overall patient satisfaction in the peri-operative period.      Finally, we want to determine whether the aforementioned outcomes relative to the chest tube     drainage systems differ in different parts of the world.   "
117505|NCT01747876|"     LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo     activity in both tumor models.      The primary purpose of this study is to determine the maximum tolerated dose (MTD) and/or     recommended dose for expansion (RDE) in pediatric patients and to delineate a clinical dose     to be used in future studies. This study will also assess the safety, tolerability, PK and     preliminary evidence of antitumor activity of LEE011 in patients with MRT or neuroblastoma.   "
117709|NCT01745198|"     In a retrospective analysis of data from 1100 patients, disease-delaying effects of     Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current     study is to expand the retrospective study dataset by prospectively collecting additional     biomarker and imaging data.   "
117506|NCT01747863|"     A multicenter observational pilot study will be conducted to determine the natural history of     infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are     not qualified for therapeutic hypothermia. The intervention includes: neurologic examination     by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home,     amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before     discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the     percentage of mild NE infants with evidence of brain injury defined by the presence of at     least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period.     Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities,     seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home,     death and long-term outcome.   "
117507|NCT01747850|"     The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially     a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to     ensure that our planned self-titration regimen is appropriate using Sativex. This phase will     be open label, with no placebo control. Then, there will be a twelve-week, double-blind,     placebo-controlled study in male and female subjects seeking treatment for cannabis     dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex     Spray or Placebo Spray) associated with a weekly intervention of combined Motivational     Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to     come daily to the centre to assess usage of medication. Following the medication phase,     participants will have a follow-up weekly for another four weeks and then monthly until the 6     month follow up visit after the target quit date. The investigators are planning to enroll 45     subjects over the two-year period.   "
117508|NCT01747837|"     The objective of this trial is to determine the efficacy and safety of adjunctive     catheter-based renal sympathetic denervation (RSDN) in the primary prevention of ICD therapy     in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD     for either i) secondary prevention, or ii) primary prevention + inducible VT by programmed     ventricular stimulation at the time of ICD implantation. These patients will be randomized to     ICD alone or ICD + RSDN.   "
117509|NCT01747824|"     The purpose of this project is to determine the levels of stress biomarkers associated with     severe pain, agitation from intoxication or psychosis, and excited delirium at various levels     of the disease in order to compare them to pre-clinical models of law enforcement encounters.     We hypothesize that the serum catecholamines and markers of metabolic acidosis will worsen     with the duration and severity of agitation among agitated patients and will not worsen among     patients with severe pain who are not agitated.      Specific Aims        -  To assess the prevalence of patients undergoing treatment for agitation from any cause          requiring restraint or sedation.        -  To assess the prevalence of excited delirium in the emergency department.        -  To determine the difference in serum total catecholamines, serum dopamine, serum          epinephrine, serum norepinephrine, heart rate, systolic blood pressure, mean arterial          pressure, mortality, and disposition among patients with agitation requiring restraint,          including excited delirium and patients with severe pain from extremity fractures.        -  To describe changes in stress biomarkers among patients with changing levels of          agitation as determined by the Altered Mental Status scale.   "
117544|NCT01747369|"     The aim of this study is to estimate the burden of disease due to pneumococci, other bacteria     and viruses in the African meningitis belt prior to pneumococcal conjugate vaccine     introduction and to estimate the population impact of the vaccine after its implementation in     2014. In a defined population of a sanitary district in northern Togo, during the period 2010     to 2017, investigators enroll patients of all ages with suspected pneumonia requiring     hospitalization or suspected bacterial meningitis. Patients are evaluated by bacteriology and     molecular biology techniques on blood, cerebro-spinal fluid, nasal aspirates and by chest     X-ray.   "
119676|NCT01719445|"     The Primary Aim of the project is to modify the RFPM for adolescents and to address the     concerns identified by the reviewers of the first grant application. We will then test the     RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.   "
117510|NCT01747811|"     Mild traumatic brain injuries (mTBI) or concussions are an increasingly prevalent injury in     our society. Patients with post-concussion syndrome have been shown to have deficits on tests     of short term memory, divided attention, multi-tasking, information processing speed, and     reaction time, as well as alteration in mood and emotional functioning. Many patients have     other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and     chronic headaches. Furthermore, sleep disruption of one of the most common complaints in     patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with     mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer     outcome, while resolution of the sleep disturbance is associated with improvement in     cognitive functioning.      Despite recent evidence of the correlation between sleep quality and recovery from traumatic     brain injury, and the well-established role of sleep in neural plasticity and neurogenesis,     there have been virtually no direct studies of the causal effects of sleep on recovery     following mTBI. However, it is quite likely that sleep plays a critical role in recovery     following brain injury.      A particularly promising non-pharmacologic approach that shows potential in     improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright     light therapy. For the proposed investigation, we hypothesize that bright light therapy may     be helpful in improving the sleep of patients with a recent history of mTBI and may also have     other mood elevating effects, both of which should promote positive treatment outcome in     these individuals. Bright light therapy may increase the likelihood that they will recover     more quickly, benefit more extensively from other forms of therapy, and build emotional and     cognitive resilience.   "
117511|NCT01747798|"     This pilot clinical trial studies auranofin in treating patients with epithelial ovarian,     primary peritoneal, or fallopian tube cancer. Immunosuppressive therapy, such as auranofin,     may be an effective treatment for epithelial ovarian, primary peritoneal, or fallopian tube     cancer.   "
117512|NCT01747785|"     This study is being done to study how well the heart contracts and relaxes during exercise.     In addition to traditional measures of heart function, we will use a new computer program     that may improve understanding of why people feel shortness of breath or fatigue.   "
117513|NCT01747772|"     HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate     quantitative measurements that can be used to stage liver fibrosis in patients with chronic     liver disease.        1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver          disease who will undergo non-focal liver biopsy as part of their routine clinical care        2. To assess the sensitivity and specificity of sonoelastography for the detection and          staging of liver fibrosis        3. To evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis          using sonoelastography   "
117514|NCT01747759|"     The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted     education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there     is lack of validated booklet containing evidence based informations.      Our aim is to assess the impact of an evidence based education pre-operative booklet on     patient's knowledge and beliefs. The secondary objectives are to assess the impact of the     booklet on patient's satisfaction on the information received, the length of stay in     orthopedic surgery and the transfer rate to rehabilitation wards.      To show a difference of 2 points on the knowledge score (range 0-10) between the two groups,     with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations     will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and     beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data     will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher     exact test.      The study protocol was approved by the local Ethic Committee.   "
117515|NCT01747746|"     The purpose of this study is to determine that a new drug called Rivaroxaban® is effective     in preventing patients from forming clots after their heart rhythm has been reset by the     cardiologist with an electrical device.   "
117516|NCT01747733|"     Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic     retrograde cholangiopancreatography). However, assessment of the level of sedation during     these procedures is not investigated in detail.      The purpose of this study is to compare different sedation scales and bispectral index during     sedation in endoscopic procedures in order to find the best suited assessment method for     sedation under these conditions.   "
117517|NCT01747720|"     There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized     controlled trials would provide definitive evidence about this effect. However, trials with     breast cancer as outcome are expensive and time-consuming. Use of surrogate outcomes has been     advocated to accelerate progress in the identification of interventions that could prevent     breast cancer. Mammographic breast density is one of the strongest breast cancer risk     indicators and is already used as a surrogate outcome in several breast cancer prevention     trials. The aim of this double-blind randomized controlled trial is to determine whether     daily oral supplementation with vitamin D3 (1,000, 2,000 or 3,000 IU) over a period of 1 year     reduces breast density in premenopausal women compared to placebo. A total of 376 women (94     per arm) who live in Quebec City will be recruited. Showing that vitamin D reduces breast     density would provide strong support for the idea that vitamin D can be a safe and     inexpensive approach for the prevention of breast cancer.   "
117518|NCT01747707|"     The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with     the PFS being around 6 months and overall survival time being 13 months in Japanese and     Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would     further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This     is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin     and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and     gastroesophageal junction cancer.   "
117519|NCT01747694|"     COPD patients often suffer from dyspnea and exercise intolerance which lower their quality of     life.The aim of this proposed study is to examine the effectiveness of multi-respiratory     muscle training on respiratory function of COPD patients.   "
117545|NCT01747356|"     Resolute zotarolimus-eluting stent (ZES) system (Medtronic, USA) has been world-wildly used     in treating patients with coronary artery disease (CAD). The State Food and Drug     Administration of China has approved qualification of RESOLUTE zotarolimus-eluting stent     system in 2010. It has been reported that RESOLUTE stent may be more suitable for DM patients     and FDA has approved diabetic coronary lesion as a indication for using Resolute stent. Here     the investigators set out a multicenter, non-inferiority study: the efficacy and safety of     RESOLUTE zotarolimus-eluting stents in treatment of Chinese diabetes (RESOLUTE-DIABETES     CHINA) in purpose of identifying the efficacy and safety in Asia CAD correlated with diabetic     population.   "
117520|NCT01747681|"     Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee     arthroscopies focal chondral or osteochondral defects were found in 19% of the patients     (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute     traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral     bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an     angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the     bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or     hyaline-like cartilage. The microfracture technique causes little damage to the subchondral     bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The     quality of the repair tissue after these bone marrow stimulating techniques depends on     various factors including the species and age of the individual, the size and localization of     the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and the     postoperative rehabilitation protocol. Microfracture has been used in small traumatic defects     in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic lesions in     older patients (Miller 2004, Steadman 2007). The purpose of the present study was to     investigate the long-term clinical outcome 10 to 14 years after microfracture of articular     cartilage defects in the knee and possible predictors of good and poor outcomes.   "
117521|NCT01747668|"     To investigate the impact of nutrient supplementation during lactation on levels in breast     milk.   "
117522|NCT01747655|"     Patients with advanced Parkinson's Disease experience a range in the severity of their motor     fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the     benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of     the disease whose motor fluctuations have become troublesome and complicate management with     oral therapy. The aim of this post-marketing observational study is to assess the effect of     Duodopa treatment on activities of daily living in advanced Parkinson's Disease participants     characterised by either 2-4 hours of off time or 2 hours of non-troublesome or troublesome     dyskinesia daily, supported by a Unified Parkinson's Disease Rating Scale Total Score in the     best on state of at least 40 points at baseline.   "
117523|NCT01747642|"     Oncoxin in combination with Surafenib is safe and results in improved survival in patients     with hepatocellular carcinoma (HCC)   "
117525|NCT01747616|"     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the elderly     population. One mainstay of therapy for patients suffering from DES is the use of topically     administered lubricants. However, despite many efforts, no ideal formulation has yet been     found.      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with     favourable biological properties such as high biocompatibility and low toxicity.     Additionally, the new formulation comprises N-acetylcysteine, which has been used in     ophthalmology because of its mucolytic properties for several years. Based on theoretical     considerations, one can hypothesize that the new chitosan derivative may show an increased     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in     reducing the symptoms associated with DES. We have recently shown in a phase I trial that     single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy     subjects.      However, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine     in subjects wearing contact lenses. This is of special interest because the tear film is     critical to successful contact lens wear. Disturbances of the quantity or quality of the tear     film results in intolerance of contact lens wear and possible damage to the ocular surface.     This trial seeks to investigate the local tolerability and possible ocular discomfort of     chitosan-N-acetylcysteine eye drops after repeated instillation .   "
117526|NCT01747603|"     This pilot study will examine the feasibility of conducting a large randomized clinical trial     (RCT) to examine the role of a novel, specialized follow-up clinic in preventing     complications among late preterm infants (LPTB), born between 34 and 36 weeks gestational     age. 1) Study Process: Success will be achieved if 80% of a target population of 100 subjects     is met within the first 6 months of recruitment being initiated. 2) Study Resources: Success     will be achieved if 80% of follow up appointments are scheduled in a timely manner and if     specialized LPTB physicians in the intervention complete assessments 75% of the time in the     allocated time frame and 3) Scientific: 95% data completeness on data collection forms will     be identified as success      A specialized LPTB follow-up clinic is innovative as no studies have evaluated such a     programme and standardized follow-up and guidelines for the care of LPTB infants after     discharge from hospital do not exist. Until recently, the incorrect assumption has been that     these infants are healthy and have limited risks compared to term infants.      The study's main question, in addition to assessing the feasibility of this pilot, is: Do     differences exist in short-tem clinical and developmental outcomes among LPTB infants     enrolled in an RCT who are randomized to a specialized LPTB follow-up programme when compared     to infants randomized to current pragmatic management? A RCT will provide evidence for the     development of guidelines for the follow-up of LPTB infants in the first 6 months of life to     reduce complications, readmissions and developmental problems.      The results of this study can be generalized to tertiary care and community hospitals and the     general population.   "
117527|NCT01747590|"     The primary goal of this double-blind, placebo-controlled, within-subjects functional     neuroimaging study is to examine the extent to which the hypnotic zolpidem decreases brain     activity in regions of the brain known to process emotional information. Although zolpidem is     an effective sleep-aid, its ability to engender anti-anxiety effects is equivocal, yet     promising. Zolpidem's activity during tasks that engage anxiety-related processes in the     brain will be compared to that of the known anxiolytic drug alprazolam, a positive comparator     caffeine, and placebo. A secondary goal of this study is to compare the subjective drug     effects, or how individuals feel, following the interventions. These measures will be used to     determine the existence of brain-behavior relationships, thus demonstrating that imaging is     an important tool for informing us about how drugs produce their effects in the brain.   "
117530|NCT01747551|"     This research study is a Phase II clinical trial to test the safety and effectiveness of the     investigational drug Ziv-aflibercept in combination with mFOLFOX6 compared to mFOLFOX6 alone.     The drugs used in mFOLFOX6 include Fluorouracil (5-FU), Leucovorin and Oxaliplatin.      In patients with esophagogastric cancer, mFOLFOX6 has been used in both clinical trials and     standard of care. Investigational means that the FDA has not yet approved this combination     for the treatment of esophagogastric cancer.      Every person has molecules in their bloodstream called vascular endothelial growth factors     (VEGFs). These molecules help grow and sustain new blood vessels needed by the human body.     Cancer tumors hijack this mechanism because they need new blood vessels and oxygen to grow.     Ziv-aflibercept is an antibody, a targeted therapy called a VEGF Trap, that traps     (binds) these VEGFs and prevents the cancer from using them to grow. Ziv-aflibercept has     recently been approved by the FDA for patients with treatment-resistant colorectal cancer.     Patients who received standard 5-fluoruracil based chemotherapy pus ziv-aflibercept lived     significantly longer than those patients who received standard 5-fluoruracil alone.      In this research study, investigators will see if adding ziv-aflibercept to standard     chemotherapy (mFOLFOX6) works better than mFOLFOX6 chemotherapy alone in patients with     metastatic or unresectable esophagogastric cancer.   "
117531|NCT01747538|"     The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of     recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently     controlled with systemic treatment.   "
117532|NCT01747525|"     The primary objective of this study is to characterize coronary artery blockages as     determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.   "
117533|NCT01747512|"     Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc     Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with     ten patients using this imaging agent showed that it was safe and produced images with the     same pattern as generator produced Pertechnetate. This study is now being done in larger     numbers of patients to again show that the imaging pattern of both agents is the same, and to     again demonstrate its safety.   "
117534|NCT01747499|"     The purpose of this phase I/II study is to define the maximum tolerated dose of 5-AzaC and     the effect on grade II-IV GvHD when given after matched unrelated donor transplant (MUD).   "
117535|NCT01747486|"     This is a randomized, open-label, parallel group study to determine the optimal dose of     CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing     tandem TCR Zeta and 4-1 BB co-stimulatory domains) of the two dose levels being assessed     (1-5x10e8 vs. 1-5x10e7 CART-19 cells). This trial will be conducted in two stages.   "
117541|NCT01747408|"     The proposed study was set up to evaluate the tolerability and safety of 25% human albumin     (HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500     people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one     third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been     identified as the most important reason for neurological deterioration. CV may be due to     multiple molecular mechanisms. The use of a neuroprotective agent with various actions, likes     HA, would be important for prevention of CV and improved clinical outcome in patients with     SAH. The proposed open-label, dose-escalation study will have important public health     implications by providing necessary information for a definitive phase III clinical trial     regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a     maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA (0.625,     1.25, 1.875, and 2.5 g/kg) administered daily for seven days will be evaluated. The lowest     dosage was to be evaluated in the first group of 20 subjects. A specific safety threshold was     defined based on data from previous studies. The Data and Safety Monitoring Board approved or     disapproved advancing to the next higher HA dosage based on the evaluation of the rate of     congestive heart failure (CHF). The study assessed three outcomes: safety and tolerability of     the HA dosages and the functional outcome. The primary tolerability outcome was defined as     the subject's ability to receive the full allocated dose of HA without incurring frank CHF     that requires termination of treatment. Secondary safety outcomes were serious adverse events     (including neurological and medical complications, and anaphylactic reactions). Neurological     complications comprise incidence of CV, rebleeding, hydrocephalus, and seizures after     treatment. The three-month functional outcome determined, by Glasgow Outcome Scale, Barthel     Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact Scale was measured to obtain     a preliminary estimate of the treatment effect of HA. The timeline of the study is three     years.   "
117542|NCT01747395|"     The investigators hypothesize that aerobic exercise training associated with respiratory     muscle training will cause additional benefits compared to isolated exercise training or     respiratory training in chronic heart failure patients.   "
117543|NCT01747382|"     Recent clinical studies have demonstrated that catheter-based renal sympathetic nerve     ablation is safe and effective in treating patients with resistant hypertension. However,     there is limited data on its safety and efficacy in patients with Chronic Kidney Disease.      The investigators hypothesize that catheter-based renal sympathetic nerve ablation is safe     and effective in the treatment of resistant hypertension in patients with Chronic Kidney     Disease.   "
120087|NCT01714063|"     The primary objective of this study is to determine ex vivo the amount of fluticasone     deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond VHC     mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation     maneuver.   "
117546|NCT01747343|"     The investigators are interested in determining those procedures that prove to be most     efficient and effective in facilitating continence (i.e., dry pants or the absence of     soiled undergarments), appropriate eliminations (i.e., voids/stools in toilet), and     independent requests/initiations to use the toilet. To assess the effectiveness of toilet     training methods (procedures), data on toileting skills (in addition to each skill in a given     child's curriculum) are collected across the school day (7:30 am-5:45 pm) by the classroom     teachers. The primary dependent variables (toileting skills) are continence (i.e., absence of     soiled undergarments), appropriate eliminations (i.e., the number of voids/stools made in the     toilet), and independent/self requests (i.e., communication by the child with an adult to use     the toilet). The toileting procedures are implemented by classroom teachers (undergraduate     practicum students) and implementation is monitored by classroom supervisors (graduate     teaching assistants). Procedural effectiveness is evaluated on a daily basis by the graduate     teaching assistants and on an at-least-weekly basis by faculty supervisors.   "
117547|NCT01747330|"     The purpose of this study is to evaluate the safety and tolerability of Creon micro in     children younger than four years with pancreatic exocrine insufficiency.   "
117548|NCT01747317|"     Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for     determining the physiologic significance of coronary artery disease (CAD), which will help     physicians in clinical decision-making and decrease the medical cost, but its ability to     identify patients with ischemia has not been adequately examined to date.   "
117549|NCT01747304|"     DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in     osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic     manufactures scanners that are able to perform high definition instant vertebral fracture     assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures     instantly and reliably at the same time they are having their yearly BMD. We wish to     investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan     mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur     in patients at risk for these debilitating fractures. In this proof of concept study, we     propose to examine whether DXA scanners can provide a sensitive low radiation screening     method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at     risk.   "
117550|NCT01747291|"     Osteoporosis is a disease characterized by increased bone fragility and deteriorating bone     micro-architecture. The main consequence of osteoporosis is low-trauma fractures, most often     of the hip, spine and wrist. Recently, another type of low-trauma fracture, atypical femur     fractures (AFFs), have received much attention. Little is known of the cause of these     debilitating fractures; however, they have been associated with long term bisphosphonate use.     What we currently know about AFFs is based on case reports or small case series, or studies     using administrative databases or secondary analyses of bisphosphonate trials. While these     reports provide some preliminary information on the relationship between long term     bisphosphonate exposure and AFFs, detailed clinical data are absent. As we have established a     network of specialists across southern Ontario our group is in a position to collect     meaningful information on a larger group of patients who have experienced these debilitating     fractures into a centralized AFF registry.   "
117551|NCT01747278|"     Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis     carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated     with high-dose glucocorticoids and immunosuppressive agents.      Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12     weeks.   "
117552|NCT01747252|"     This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC)     containing resveratrol compared with a reference. RGC will be administered as single oral     dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total     conjugates will be analyzed.   "
117926|NCT01742377|"     The purpose of this study to assess efficacy of SE endoscopy in the detection of MCE in     dyspeptic patients with or without GERD diagnosed by GerdQ or by endoscopy + PHM and in     normal volunteers.   "
117553|NCT01747239|"     Ovarian cancer patients are considered platinum refractory if their disease worsens during     primary platinum treatment or if they have no effect of the treatment. This constitutes a     major therapeutic problem and new treatment approaches are highly needed.      Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both     tumors it has effect in patients refractory to taxotere. Consequently, it could be     anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.   "
117554|NCT01747226|"     Bad breath or halitosis is caused by specific gases originating from the mouth or the expired     air. In most cases the pathology lies within the mouth and in this case receives the name     pathologic halitosis of oral cause or oral malodor. The aim of this study is to evaluate the     immediate (masking) and long term (therapeutic) effect of commercially available mouth rinses     in the treatment of oral malodor. For this volunteers with oral malodor detected by     organoleptic evaluation and confirmed by the increase level of sulphur compounds in their     breath (VSC) will be asked to use a designated mouthwash. The breath parameters will be     assessed at baseline and 15' after the first rinse (15 ml, during 1 minute) and over night at     the end of a period of 3 weeks during which the volunteers rinsed twice a day (15 ml, 1     minute) with the assigned mouthwash. The short and long term effect of a stannous     fluoride/amine fluoride/zinc rinse; a chlorhexidine/cetylpyridinium chloride/zinc product and     a negative control(fluoride rinse and/or water) will be compared.   "
117582|NCT01746862|"     This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group     controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects     will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose,     for 12 months (12 months of treatment in the test group, and 6 months of no treatment and     then 6 months of treatment in the control group).   "
117583|NCT01746849|"     The purpose of this study is to help determine if palifermin and leuprolide acetate can help     the immune system recover faster following a stem cell transplant. Blood stem cells are very     young blood cells that grow in the body to become red or white blood cells or platelets. The     transplant uses stem cells in the blood from another person. The donor can be a family member     or a volunteer donor. This is called an allogeneic stem cell transplant.      The investigators want to see if palifermin and leuprolide acetate can help the immune system     recover faster after an allogenic transplant because experiments have shown they may be able     to do this.   "
117555|NCT01747213|"     Background:      - Alzheimer s disease (AD) is a brain disease that impairs memory, cognitive abilities and     the ability to function independently. It is the most common cause of dementia in older     people. It is caused by abnormal proteins in the brain that affect how neurons communicate     with each other. Researchers are looking for drugs that can slow down the disease or treat     its symptoms. One drug, called bisnorcymserine (BNC), may help improve brain function and     symptoms in people with AD. BNC is designed to block a chemical that affects how neurons     communicate with each other. Researchers want to see how BNC works in healthy older     volunteers.      Objectives:      - To look at how the body processes bisnorcymserine taken by mouth and how safe it is for     healthy older volunteers.      Eligibility:      - Healthy volunteers at least 55 years of age.      Design:        -  Participants will be screened with a physical exam, medical history, and blood and urine          tests.        -  Within 3 weeks from the screening visit, participants will come to the National          Institute on Aging clinical unit for a 2-night stay. On the morning of the second day,          they will take either a BNC capsule or a placebo. They will not know which tablet they          are taking.        -  Blood samples will be collected frequently throughout the second and third days of the          study visit. The last blood sample will be collected about 32 hours after taking the          study capsule. Participants will have heart function tests and other exams during the          visit. Once the tests are done, they will leave the clinical center.        -  Participants will have a final follow-up visit about 1 week after leaving the clinical          center.   "
117556|NCT01747200|"     Background:      - The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record     these rhythms. When people identify the picture of a familiar object shown on a computer     screen, the communication between certain regions of the brain increases. An EEG can detect     these communication brain waves. Transcranial magnetic stimulation (TMS) can affect these     brain waves by slightly changing the brain s rhythms. Researchers want to see if changing     brain rhythms with TMS interferes with the ability to identify pictures of familiar objects.     This study will provide more information about how TMS can affect brain waves and behavior.      Objectives:      - To see if TMS can interfere with the brain s ability to identify pictures of familiar     objects.      Eligibility:      - Healthy volunteers between 18 and 70 years of age.      Design:        -  This study requires two visits to the clinical center. The first visit will last about 2          hours. The second visit will last about 4 hours.        -  Participants will be screened with a physical exam and medical history.        -  At the first visit, participants will have an object recognition test. Participants will          look at pictures of several objects on a computer screen. They will then have to state          whether the objects they see on the screen are familiar. The object recognition test          will be done along with TMS.        -  At the second visit, participants will have an EEG while taking the object recognition          test. Brain waves will be monitored during the test. They will then repeat the test          while having repetitive TMS to study its effect on object recognition. The participants          will then take the object recognition test alone for a final time. This will make sure          that TMS effects (if any) on the ability to identify familiar object images are no          longer present.   "
117557|NCT01747187|"     Septic shock is a major cause of death in intensive care. Septic shock is often dominated by     profound changes in organ functions, of which cardiac failure is one of the most severe. In     septic shock, biological markers of cardiac stress are often elevated. It is not known to     what extent this indicates structural damage to the heart, or in what way they correlate to     echocardiographic signs of heart failure.      Here, cardiac failure in ICU patients with septic shock is studied, using biological markers     of cardiac stress, inflammatory parameters and echocardiography.      Investigators hypothesize that biomarkers of cardiac stress correlate with echocardiographic     signs of heart failure, and that they can predict an increased risk of death.   "
117558|NCT01747174|"     The purpose of this study is to determine whether intra-coronary adenosine or sodium     nitroprusside (SNP) delivered selectively via a thrombus aspiration catheter (or if     unsuccessful via a coronary microcatheter) following thrombus aspiration in Primary     Percutaneous Coronary Intervention (P-PCI) reduces microvascular obstruction (MVO) parameters     and infarct size as measured with cardiac MRI, compared with standard treatment following     thrombus aspiration in patients presenting with ST-elevation myocardial infarction (STEMI).   "
117627|NCT01746264|"     Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents     have a high prevalence of Vitamin D deficiency as well as evidence of endothelial     dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with     Vitamin D would lead to improvement in endothelial dysfunction.   "
117559|NCT01747161|"     In this study we will investigate the efficacy and safety of infiltration of the vestibulum     vaginae with botulin toxin in women who were diagnosed with localized provoked vulvodynia. In     literature covering this subject we find that the prevalence of this condition is between 10     and 15%. Especially young, sexually active women suffer from this problem and some of them     are not capable of having sexual relations with their partner because of this burning pain.      The most probable explanation for the physiopathological mechanism is an increase of nerve     endings in the epithelium of the vestibulum, with an increase and activation of pain     receptors in the vestibular mucosa. It also seems that patients with vestibulodynia have a     higher tonus of the pelvic floor muscles, a greater muscle contraction in response to pain     and a lower capacity of relaxation.      Botulin toxin (Botox) is a neurotoxin that causes a temporary paralysis of the muscle cells.     That way it can decrease the increased tension of the pelvic floor muscles Botox also     inhibits the pain receptors in the vestibulum.      Patients will be recruited through the gynecology consultations. Every patient with localized     provoked vulvodynia that has tried previous treatments (pelvic floor muscle therapy,     antidepressants, anti-epileptics, local anesthetics) will undergo Q-tip testing. If positive     and there are no underlying diseases, the patient will be invited to participate in the study     and after oral and written informed consent, will be included in the study population. Every     6 weeks there will be given injections with 50 units of botulin toxin, on 6 different spots     in the vestibulum. 50 % of the subjects will receive physiological water instead of Botox     (control population). After 3 sessions, we will assess if there is any difference in provoked     pain in treated patients vs. placebos through Q-tip testing.   "
117560|NCT01747148|"     Background:      - Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes     only a mild illness, but some people can become seriously ill or even die from it. Currently,     some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms     end about a day sooner. More treatment choices for the flu are needed, especially for those     who become seriously ill. Researchers want to test a new drug, AVI-7100, that might keep a     person who takes it from having a more serious case of the flu.      Objectives:      - To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug.      Eligibility:      - Healthy volunteers of normal weight between 18 and 60 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. A heart function test will also be performed.        -  Participants will have either AVI-7100 or a placebo infusion. They will not know which          infusion they have. . Participants will stay at the clinical center for a total of 8          hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after the          end of the infusion        -  Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood and          urine samples will be collected. A heart function test will also be performed.        -  There will be a second part of the study that is separate from the first one. Additional          people will receive either AVI-7100 or placebo to test their reactions to a specific          dose.   "
118623|NCT01733277|"     The primary objective of this study is to identify osteoarthritis (OA) structural changes, as     assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the     PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee     experiencing moderate to severe pain (VAS ≥ 40 mm).   "
117561|NCT01747135|"     Background:      - Hydroxypropyl beta cyclodextrin (HPBCD) is being tested for a disease called Niemann-Pick     disease type C1 (NPC1). NPC1 is a genetic disorder that results in gradual loss of nervous     system function. Cholesterol and other fats have trouble moving out of the brain cells, which     makes the cells work poorly and leads to symptoms. There is no treatment currently approved     in the US for NPC1. Researchers want to test if it is safe to use HPBCD for NPC1. They want     to see if it can help brain cells process cholesterol better.      Objectives:      - To test the safety and effectiveness of HPBCD for NPC1.      Eligibility:      - Individuals between 2 and 25 years of age who have been diagnosed with NPC1 and who have     not already received HPBCD in an attempt to treat NPC1.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide blood and urine samples for screening. They will also have neurological tests,          including tests of hearing, speech and movement.        -  Participants will have a lumbar puncture (also called a spinal tap) every month to          deliver the drug to the spinal fluid that surrounds the brain. The length of the trial          will be determined by the safety and efficacy information that is obtained.        -  Treatment will be monitored with frequent blood and urine tests, cerebral spinal fluid          tests, hearing and neurological exams.   "
117562|NCT01747122|"     The investigators plan to compare epidurals versus wound catheters for effects on pain relief     and recovery following open liver surgery.   "
117563|NCT01747109|"     Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure     after crash induction remains a critical event.      The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is     more efficient than the face mask for preoxygenation before orotracheal intubation after     crash induction in acute hypoxemic respiratory failure   "
117564|NCT01747096|"     Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in     Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in     routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).      Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected     results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy     octreoscan ®, with a potential impact on the therapeutic management of patients.   "
117565|NCT01747083|"     This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl     sustained release) 50/1000mg(25/500mg x 2tablets)   "
117566|NCT01747070|"     The objective of this study is to evaluate the efficacy of transcranial direct current     stimulation (tDCS) and electro acupuncture (EAC) compared to sham treatment in reducing pain,     improving functional capacity and functioning of the neuro-immune-endocrine system in     patients with chronic pain due to knee osteoarthritis.   "
117567|NCT01747057|"     Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will     improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious     effects of fluid overload.   "
117628|NCT01746251|"     This research study is a Phase II clinical trial, which tests the safety and effectiveness of     an investigational drug to learn whether the drug works in treating a specific cancer.     Investigational means that the drug is still being studied. It also means that the FDA has     not yet approved afatinib for use in patients.      In this research study the investigators are looking to see if taking afatinib after surgery     works better when taken over a short period of time, compared to a long period of time.   "
136072|NCT01503684|"     In this proposal, the investigators wish to investigate, identify and validate potential     biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.   "
117568|NCT01747044|"     Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men.     In France, the prevalence is 1.6% according to a French study conducted in 2009 and published     in 2011 by Serge Perrot et al.      The definition of fibromyalgia was recently amended with particular consideration of     cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR     classification. Several factors are in favor of a malfunction of the central modulation of     pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious     inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse     noxious inhibitory controls) are altered with less pain inhibition than controls. Dysfunction     of the central pain modulation is widely described in the literature and contributes to pain     complained of fibromyalgia.      According to the Recommendations of the European League Against Rheumatism (EULAR) 2006,     antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an     antidepressant known and used in major depressive disorder according to its marketing     authorization but is also part of the molecules used in the treatment of chronic neuropathic     pain and fibromyalgia according to the recommendations of the EULAR. A review included five     double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo     over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of     participants treated for each dose of milnacipran on the criteria of at least 30% pain     relief Impression and global change. Substantial improvement with milnacipran compared to     placebo has been shown.      To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug     treatment has not been shown.      This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be     predictive of the efficacy of milnacipran.   "
117569|NCT01747031|"     The iFRCT study is a prospective, multicenter study to evaluate the diagnostic performance of     iFRCT with the use of ≥64-detector row CT scanners for the detection and exclusion of     significant obstructive coronary artery disease, defined by invasive fractiona flow reserve     (FFR) as the reference standard.   "
117570|NCT01747018|"     Platelet-rich plasma (PRP) has been used as an alternative to non-operative treatments for     increasing the rate of cure in bone and soft-tissue regeneration, although there are very few     clinical studies regarding the treatment of articular cartilage damage. Therefore, our study     proposes non-surgical intervention for patients with articular cartilage damage and who are     experiencing knee pain caused by this damage.      This study was conducted as a single medical center. It was an uncontrolled, prospective     clinical trial, and the study subjects included 44 patients who were suffering from early     osteoarthritis and degenerative chondropathy; they were between 18 and 65 years of age and     were included in the study irregardless their sex. PRP was injected twice intraarticulary     within an interval of four weeks. The pain scores and functional scores were compared two     months, four months, and six months following the second injection was completed, using the     VAS, the Lysholm knee scale, and the Cincinnati knee rating system.   "
117571|NCT01747005|"     The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on     inflammatory response after abdominal hysterectomy.   "
117584|NCT01746836|"     The goal of this clinical research study is to learn if ponatinib can help to control CML in     chronic phase. The safety of this drug will also be studied.      Ponatinib is designed to block the function of BCR-ABL, which is the abnormal protein     responsible for causing CML. This may cause the cancer cells to die.      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or     death. A blood clot may occur within 2 weeks after you start taking the drug. About 25% (1 in     4) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that     do not have other known risk factors for forming clots. If you develop a blood clot, you will     need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the     clot and restore blood flow.   "
117572|NCT01746992|"     T cell lymphoma is a heterogenic malignancy with poor outcome. Five-year PFS and OS of the     patients recieved classic CHOP regimen(cyclophosphamide,vincristin,doxorubicin and     predisone)is less than 30%.High dose intensive chemotherapy doesn`t demonstrate better     response. At present, there is no standardized treatment protocol for this kind of lymphoma.      Between 1994 and 1998,the Scotland and Newcastle Lymphoma Group prospectively collected data     on newly diagnosed patients with enteropathy associated T-cell lymphoma (EATL)in the Northern     Region of England and Scotland,which is a rare and aggressive type of peripheral T-cell     lymphoma.The novel regimen IVE/MTX (ifosfamide, vincristine, etoposide/methotrexate)-ASCT was     piloted for patients eligible for intensive treatment,followed by auto-stem cell     transplantation.Five-years PFS and OS were 52% and 60% respectively, significantly improved     compared with the historical group treated with anthracycline-based chemotherapy. The     encouraged results were extended to the peripherial T cell lymphoma-non specified(PTCL-nos).      Past studies suggested pirarubicin was more active to the T cell lymphoma than doxorubicin in     vitro based on its high concentration in tumor cells. Clinical data also presented equivalent     even superior efficacy of pirarubicin with lower toxicity than doxorubicin. The aim of our     study is to compare the response and survival rate of CTOP/ITE/MTX (cyclophosphamide,     vincristin,pirarubicin and predisone/ ifosfamide, pirarubicin, etoposide/methotrexate) with     those of CHOP regimen,looking forward to its superiority in efficacy and safety for the de     novo young patients with T cell lymphoma.   "
117573|NCT01746979|"     This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in     combination with TH-302 compared to gemcitabine in combination with placebo in subjects with     locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects     will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there     is evidence of progressive disease, intolerable toxicity, or the subject discontinues from     the trial for other reasons (for example, withdrawal of consent). The primary efficacy     endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the     primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No     planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB)     will provide periodic evaluations of the unblinded safety data to ensure subject safety and     the validity and scientific merit of the study. A total of 660 subjects will be enrolled.   "
117635|NCT01746160|"     The aim of the study is to describe the changes found in C1 dental implants through their     early healing period.      Patients requiring a standard installation of one or two implants in the maxilla, without any     need for bone augmentation, will be frequently followed for 90 days. In every meeting the     implants' ISQ values (values denoting the implant stability as being measured by a dedicated,     commercially available, appliance called 'Osstell').      The implants' measured ISQ values will be used to describe the changes that may be found in     the implants' stability through their healing period.      At the end of the study the patients will be referred to their treating doctor for the     completion of implants' restoration (i.e. crown).   "
117574|NCT01746966|"     1. Investigate Gleno-Humeral Joint (GHJ) by anterior approach:           A - Measurement of GHJ thickness at 3 points and average value calculation on body          supine position and with arm supinated, maximal externally rotated with elbow angle 90          degrees             -  By longitudinal access with transducer position laterally to coracoids along to the               GHJ line, located as diagonal form lower to forward and lateral direction with               demonstration the joint cartilage posteriorly and subscapular tendon anteriorly               (Fig.4)             -  By transversal access with 90 degrees to longitudinal and at 3 points: upper with               coracoids visualization, middle and lower (Fig.5-7).           B - Measurement of rotator interval with assessment of width and higher.        2. Comparison of the data with results of classic values have been received by posterior          and inferior (axillar) approach.        3. Comparison of the results between patients with Rheumatoid Arthritis (RA) and healthy          controls   "
117575|NCT01746953|"     We will evaluate the effect of red blood cell (RBC) transfusion on fatal and non fatal events     according to baseline risk of death in an international cohort of trauma patients (CRASH-2     trial). The following outcomes will be considered: death from all causes, death due to     bleeding, death due to multiorgan failure, death due to vascular occlusive events and non     vascular occlusive events. Non fatal outcomes include: myocardial infarction, stroke, deep     vein thrombosis and pulmonary embolism.   "
117576|NCT01746940|"     This study aims to evaluate topical application of Cocaine HCl 4% and 10% on safety and     efficacy in local (topical) anesthesia for diagnostic procedures and surgeries on or through     accessible mucous membranes of the nasal cavities.   "
117577|NCT01746927|"     This investigation was designed to assess if the the position of esophageal entrance would     detrmine the cricoid force necessary to occlude the esophageal lumen? in anesthetized,     paralyzed non obese patients using the Glidescope ® video laryngoscope (GVL).   "
117578|NCT01746914|"     72 hours after lung transplantation, patients undergo a positron emission tomography (PET)     scan and a computed tomography (CT) scan in order to analyse lung function and morphology.      Aim of the study is to analyse complications onset (in particular primary graft dysfunction),     and evaluate 90 days mortality after lung transplantation.   "
117579|NCT01746901|"     The main purpose of this study is to determine if oxycodone and naltrexone combination     capsules (ALO-02) have the potential to be abused.   "
117580|NCT01746888|"     Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in     the Emergency Department do not currently exist. These patients often have atypical     presentations which can complicate diagnosis and treatment. The development of an     antimicrobial stewardship program for Emergency Department older adult patients can     ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This     research study involves data collection from enrolled subjects and treating physicians. The     data will be collected using a patient interview which will be answered directly by the     patient or caregiver. Additional surveys will be administered to the Emergency Department     treating physician and subsequent physician. Additional data will be abstracted from the     Emergency Department chart and from additional charts that often accompanies the patient to     the Emergency Department. A physician adjudication process will occur if there is     disagreement in diagnosis between the treating Emergency Department physician and succeeding     physician.   "
117581|NCT01746875|"     The purpose of this study is to determine treatment effects in patients with retinal pigment     epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly     diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either     treatment or observation. The treatment group will first be given injections with anti     Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect,     Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a     period of 2 years. It is hypothesized that treatment stops the progression of the disease and     stabilizes the vision in this subgroup of patients with AMD.   "
117585|NCT01746823|"     There is currently no medication for containing KC, nor any adequate biomarkers to predict     the disease. Furthermore, there is considerable confusion in the field regarding the     pathophysiology of the disease and involvement of inflammation. To that end, this study is     designed to address some of these questions by determining the proteomic profiles of KC     patients with different clinical grades. This relatively large cohort study is expected to     yield significant information regarding the molecules that are deregulated during progression     of KC and may provide a framework to assign diagnostic biomarkers and therapeutic     intervention points.   "
117586|NCT01746810|"     This phase I trial studies the side effects and best dose of stereotactic body radiation     therapy when given together with ablation therapy in treating patients with non-small cell     lung cancer or lung metastases. Ablation therapy, such as radiofrequency ablation uses a     high-frequency, electric current to kill tumor cells. Ablation therapy, such as microwave     ablation kills tumor cells by heating them to several degrees above normal body temperature.     Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and     cause less damage to normal tissue. Giving ablation therapy together with stereotactic body     radiation therapy may kill more tumor cells.   "
117587|NCT01746797|"     This study assesses risk factors for depressive relapse in women undergoing fertility     treatment with histories of major depressive disorder (MDD) or bipolar disorder. The study is     focused on the acute risk factors of depressive relapse.      The investigators hypothesize that risk for depressive relapse will be greater among women     who stop antidepressants compared to those who continue treatment with these agents.   "
117588|NCT01746784|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR     function and inflammation in adult cystic fibrosis subjects who are homozygous for the     F508del-CFTR mutation.   "
117589|NCT01746771|"     [Phase I] The main objective of this study is to evaluate the safety, tolerability and     determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and     Trastuzumab      [Phase II] The main objective of this study is to evaluate anticancer activity through     determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and     Trastuzumab in patients with HER-2 positive advanced gastric cancer   "
117590|NCT01746758|"     The study hypothesis is that managed referral of patients at community level (from drug     stores) increases uptake of reproductive health (RH) services at dispensary and health centre     levels.      The intervention is currently being implemented in 2 districts (Magu and Sengerema) in Mwanza     Region on the northwest shore of Lake Victoria. It is nested within the IntHEC Community     Randomised Trial which aims to evaluate the impact of a complex RH intervention on the uptake     and integration of reproductive health services in 2 Regions in Tanzania (Mwanza and Iringa)     and Niger (Say and Aguie) respectively. 18 wards per region were stratified according to     geographical and economic criteria and randomly assigned to intervention or comparison wards.     The SMS intervention is being implemented in 9 intervention wards in Mwanza Region only. 9     wards are followed for comparison.   "
117591|NCT01746745|"     This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants     to study how the body absorbs and removes LY2940680 from the blood. This study is for     research purposes only and is not intended to treat any medical condition.   "
117592|NCT01746732|"     The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives     (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones     found in the blood will be measured and compared when taken alone and when taken with     evaceptrapib. Each woman will participate in two study periods. Information about any side     effects that may occur will also be collected.   "
117593|NCT01746719|"     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,     two-period, crossover pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fasting     condition in healthy, adult human subjects.   "
117594|NCT01746706|"     Reliable diagnosis of Alzheimer's Disease (AD) at the predementia stage is currently     considered to be a priority for research, as disease modifying therapies are being evaluated.     Many studies focus on the functional and morphological assessment of the hippocampal     formation. However, neurofibrillary tangles, associated with cognitive deficits, initially     affect the anterior subhippocampal cortex (transentorhinal, entorhinal and perirhinal cortex)     before reaching the hippocampus. Studies from our group have tried to investigate if the     assessment of subhippocampal regions using cognitive tools and neuroimaging techniques could     contribute to the diagnosis of AD at a very early stage.      In a previous project, the investigators included 40 patients with single domain amnestic MCI     (Mild Cognitive Impairment), known to be at high risk for AD and demonstrated that aMCI     patients with a profile of subhippocampal dysfunction (impaired performance on a visual     recognition memory task) display other clinical as well as imaging profiles of patients with     early AD using MRI and SPECT. Longitudinal follow-up data in these patients is currently     under way. Preliminary data indicates that evaluating the subhippocampal region using visual     recognition tasks is highly predictive of AD over 6 years.      The aim of this project is to obtain additional diagnostic data using a PET amyloid tracer     (Florbetapir F18 AV45 F18), an in-vivo marker of one of the neuropathological lesions that     define AD, of in order to enhance diagnostic accuracy AD in these patients. This approach     will validate the hypothesis as to whether the assessment of subhippocampal dysfunction can     contribute to the early diagnosis of AD.   "
117603|NCT01746589|"     Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic     LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight®     Allegretto Wave® Eye-Q Laser. The use of advanced technology may decrease the loss of     contrast sensitivity and improvement of postoperative visual acuity results.   "
117604|NCT01746576|"     The purpose of this study is to determine whether analysis of near infrared absorbance     signals that occur at different frequencies might provide information about the difference in     oxygen saturation between arterial and venous blood.   "
118624|NCT01732445|"     This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating     anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body     to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.   "
117595|NCT01746693|"     Amblyopia is a developmental condition that is characterized by reduced vision of the eye due     to the presence of a sensory impediment during visual development, such as strabismus (ocular     misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent     studies in humans and animals point towards a cortical locus for the processing deficit in     amblyopia, revealing sensory deficits at the signal cell level. If changes in retinal     neuronal function are also present, is unknown.      Like in the brain, blood flow in the retina is coupled to neuronal activity. This phenomenon     has been measured by different study groups with non invasive techniques in the brain and     retina. It has been shown in previous studies that stimulating the retina with diffuse     luminant flickering light increases retinal vessel diameter and blood flow. However, it is     unknown whether this is also the case in the retina of amblyopic eyes. Additionally, the     introduction of blood oxygen level dependent (BOLD) fMRI also makes it possible to directly     access the vascular response in the brain to visual stimuli.      Therefore, the aim of the present study is to investigate the effect of luminant flickering     light on retinal vessel diameter and retinal blood flow in subjects with amblyopia. Also,     oxygen saturation in retinal vessels will be assessed as well as pattern ERG for assessment     of retinal function. Additionally, a high resolution image of the visual pathway will be     taken with 7 Tesla MRI to investigate whether anatomical or functional alterations are     present.   "
117596|NCT01746680|"     The aims of this study are to assess the efficacy and safety of tacrolimus in patients with     active rheumatoid arthritis(RA). EULAR(European League Against Rheumatism) response at week     24 compared to baseline will be evaluated to assess the efficacy of Tacrolimus.   "
117597|NCT01746667|"     The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual     reality for social anxiety disorder. 70 patients with social anxiety disorder will be     randomized to either one of the active conditions or to a waiting-list condition.     Participants on the waiting-list will be offered either exposure in vivo of in virtual     reality after a waiting period of five weeks. Levels of psychopathology will be assessed at     pre- and post-treatment as well as three and 12 months after treatment.   "
117939|NCT01742208|"     This Phase 2 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),     safety and efficacy of LX4211 following daily oral administration for 29 days in patients     with type 1 diabetes mellitus (T1DM).   "
117600|NCT01746628|"     When having certain types of outpatient surgery inside the uterine cavity some women     experience heavy bleeding. The only method presently available for controlling such bleeding,     short of removing the uterus, involves the placement of a balloon pressure device inside the     uterine cavity. The pressure along with the patient's own natural clotting ability will     generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay     in the hospital. The investigators are researching the use of a compound (FloSeal) already     approved for use in other areas of the human body, as a method of controlling bleeding. The     use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA     approved indication for its safe use to control bleeding from the uterine cavity. In this     study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity.      Twenty individuals will be included in this study at Northwest Hospital Center. All twenty     individuals will be treated in the same fashion except ten of the participants will randomly     be assigned to receive FloSeal and ten will not.      Study participants are individuals currently scheduled to have a hysterectomy procedure,     which involves surgically removing the uterus from the body for a previously determined     standard of care treatment for a non- cancerous medical problem. Before performing the     hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity     the following will be done. Once under anesthesia the uterine cavity will be subjected to a     curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the     uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into     their uterine cavity. The study participants will not know whether they received FloSeal or     not. A balloon pressure device will then be placed into the uterine cavity of all 20     individuals and left in place for 5 minutes. After the allotted time, the balloon device will     be removed. The hysterectomy will then be completed appropriately using standard methods and     techniques. The uterus, once removed will be evaluated pathologically to determine the     effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the     same analysis in those individuals who did not receive FloSeal. The pathologist will not know     which patients received or did not receive FloSeal.      This use of FloSeal is not currently an FDA approved use of the compound. The goal of this     study is to obtain FDA approval for use in this situation.   "
117601|NCT01746615|"     Assessment of retinal vessel calibers combined with bidirectional Fourier domain optical     coherence tomography (FDOCT) for measurement of retinal blood velocities is a new and     sophisticated method for assessing retinal blood flow in humans. The valid measurement of     retinal blood flow is of significant importance, because it is known that major ophthalmic     diseases are associated with alterations in blood flow.      As such, retinal vascular occlusive diseases represent a major cause of visual impairment and     blindness. The prevalence of the disease is between 0.7 and 1.6%. Compression of the retinal     veins at arterio-venous (AV) crossings plays an important role in the development of branch     retinal vein occlusion (BRVO). The mechanical narrowing of the vessel lumen is supposed to be     the mechanism behind this fact. The present study should elucidate how BRVO influences     retinal blood flow at retinal vessel crossings in comparison to healthy control subjects.     Retinal blood flow at retinal bifurcations will also be assessed. In addition, a fundus image     will be taken to assess retinal oxygen saturation.      For the first time we use a combination of a dynamic vessel analyzer (DVA) with bidirectional     Fourier domain optical coherence tomography (FDOCT) to assess retinal blood flow. Whereas the     DVA provides information concerning retinal vessel caliber, FDOCT provides laser Doppler     information in addition to conventional optical coherence tomography, allowing the     observation of blood flow dynamics simultaneously.      In the present study we hypothesize that the DVA in combination with FDOCT is a suitable new     tool for the assessment of blood flow in healthy subjects and in patients with BRVO.   "
117602|NCT01746602|"     Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of     dry eye syndrome with all known consequences such as ocular discomfort and epithelial     keratitis. Given that thinning of the tear film appears to be a risk factor for the     development or the aggravation of dry eye syndrome, the current study seeks to investigate     whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs     in healthy subjects.      For this purpose, tear film thickness will be measured at baseline and after single     instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20     subjects will receive no drug and will serve as a second control. Drug effects on tear film     thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film     thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without     preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal     HA, Hylo-Comod, Thealoz).   "
117605|NCT01746563|"     To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal     photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral     proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA),     mean change in central retinal thickness (CRT) as measured by time-domain optic coherence     tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).   "
117606|NCT01746550|"     The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in     the treatment of superficial femoral artery and proximal popliteal artery blockages in     Japanese patients.   "
117607|NCT01746537|"     A prospective, observational, case series investigating the feasibility of utilizing OCT     scans of the anterior chamber of eyes with uveitis.   "
117608|NCT01746524|"     This post-marketing investigation will evaluate the functional knee performance of Subjects     who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one     of four contemporary knee configurations will be pooled to establish a contemporary dataset.      The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1     day before surgery) to minimum one year (approximately 304 to 668 days) postoperative     functional performance improvement for the Attune™ primary, cemented TKA system as measured     by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score     (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant     configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating     platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior     stabilized rotating platform (Attune™ PS RP).   "
117609|NCT01746511|"     The purpose of this study is to find out if giving glycerin suppositories will help decrease     the length of time premature infants need phototherapy.      The investigators hypothesize that glycerin suppositories (initiated along with phototherapy)     will have no effect on reducing duration of phototherapy in premature infants with jaundice.   "
117636|NCT01746147|"     The ALLIVE (ALLogeneic Iron inVEstigators) trial aims at quantifying the extent and dynamic     change of LPI occurrence during conditioning and at identifying LPI-predictive     peri-transplant parameters. Further points of interest are the improvement of systemic iron     overload (SIO) diagnostics and the correlation of different SIO parameters with outcome after     transplantation. The results of this trial will help to design prospective interventional     studies addressing therapeutic options in patients at risk for SIO-associated toxicity during     allogeneic stem-cell transplantation (allo-SCT).   "
139667|NCT01456572|"     The purpose of this study is to determine the reciprocal control between gastric functions     and intestinal parameters in the development of satiation in obese people.   "
117610|NCT01746498|"     The current study is planed to compare the efficacy of real (anodal and cathodal) vs sham     transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal     cortex (DLPFC) on cognitive functions and cortical excitability of patients with Alzheimer     disease (AD).      Thirty three with mild to moderate Alzheimer's disease (AD) patients (diagnosis of probable     AD according to the criteria of the National Institute of Neurological and Communicative     Disorders and Stroke Alzheimer Disease and Related Disorders Association [NINCDS-ADRDA] were     included in this study) were randomly classified into one of three groups (eleven for each     group). The first group received anodal tDCS over left DLPFC and 2rd group received cathodal     tDCS on the left DLPFC and the 3rd group received sham tDCS stimulation, daily for 10     consecutive days (5 days/week for 2 weeks). Minimental State Examination (MMSE), psychometric     assessment for cognitive functions (MMSE, Wechsler memory scale, Wechsler adult Intelligent     scale) were assessed before, after 10th sessions, and then after 1 and 2 month. Cortical     excitability was assessed in both hemispheres before and after the end of sessions.     Neurophysiological evaluations included resting and active motor threshold (rMT and aMT), and     cortical silent period (CSP).      At the time of recruitment, none of the patients taking antidepressants, or neuroleptic,     sedative-hypnotic drugs for at least two weeks before the assessment. All participants or     their caregivers will give informed consent before participation in the test and after full     explanation of the study protocol.      Outcome: The real group received (anodal and cathodal) tDCS are expected to have more     improvement on cognitive functions compared to sham tDCS group. tDCS is considered new     adjuvant non pharmacological therapeutic tool for management of AD patients with mild to     moderate degree dementia.   "
117611|NCT01746485|"     To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers   "
117612|NCT01746472|"     Effective evidence-based interventions exist for smoking cessation delivered over the     Internet, but consumer acceptance and adherence remains low. Scalable and efficient     mechanisms to disseminate these interventions online are needed, and existing online social     networks provide a potential mechanism. This is a proposal for a randomized, factorial trial     of the dissemination of an evidence-based intervention through the massive Facebook social     network, with the goal of determining intervention characteristics that drive viral spread.   "
117613|NCT01746459|"     Currently, the health care that people receive is approximately 20 years behind up-to-date     research findings. Developing ways to narrow the gap between evidence and practice is an     important research focus in continuing care facilities, especially when one considers that     the demand for these facilities is estimated to increase ten-fold in the next 25 years. In     Alberta, there are an estimated 27,400 healthcare aides working in the continuing care     sector. Developing reminders targeting these care providers will increase the likelihood that     the significant resources invested to promote the uptake of research findings will lead to     sustained practice change and, ultimately, improved client outcomes. The purpose of the START     project (Sustaining Transfers through Affordable Research Translation) is to help bridge this     gap between research and practice in supportive living and long-term care facilities by     studying the effectiveness of reminder interventions to support the sustainability of a     research-based mobility innovation. In particular, the project will evaluate the frequency     and intensity of reminders that maintain the daily practice of healthcare aides to carry out     a mobility innovation with clients in 24 supportive living and long-term care facilities. We     will compare monthly versus every three month reminders, and we will compare paper-based     reminders (like a sticker on a chart) and reminders provided by a healthcare aide peer. Using     interviews, questionnaires and observations, the START project will also evaluate the     processes that inhibit or promote the uptake of the mobility innovation by healthcare aides     in their daily practice. In building this bridge between research evidence and practice, we     will work closely with stakeholders at all levels of healthcare delivery (e.g. healthcare     aides, facility leaders, policy makers and researchers) throughout the study. We expect our     collaboration to contribute to sustainable innovations in the continuing care sector and, in     particular, to the sustained use of an affordable mobility innovation in supportive living     and long-term care settings.   "
117614|NCT01746446|"     The purpose of the study is to test a new model of care for patients with an ongoing or     significant medical condition.   "
117615|NCT01746433|"     The main objective of this study is to compare the percentage of patients that successfully     pass from a laying position to a sitting position in less than 10 seconds between study arms:        -  experimental arm: these patients will use the ERGONOME device to help them sit up        -  standard arm: these patients will use traditional hanging triangle bar to help them sit          up   "
117616|NCT01746420|"     The purpose of this study is to determine whether recombinant human platelet-derived growth     factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis     elbow).   "
117617|NCT01746407|"     Procure blood specimens from individuals presenting to the emergency department (ED) with     signs and /or symptoms of systemic infection or sepsis. The samples will be used for research     and development activities related to sepsis, infections, etc.   "
117715|NCT01745120|"     This is a non-randomized, open label, multi-site, single-dose, Phase 1/2 study in up to 18     subjects (including at least 3 adolescents between 12 and 17 years of age, inclusive) with     beta-thalassemia major. The study will evaluate the safety and efficacy of autologous     hematopoietic stem cell transplantation (HSCT) using LentiGlobin® BB305 Drug Product     [autologous CD34+ hematopoietic stem cells transduced with LentiGlobin® BB305 Lentiviral     Vector encoding the human β-A(T87Q)-globin gene].   "
117618|NCT01746394|"     The Delta Healthy Sprouts Project is a randomized, controlled trial evaluating the     enhancement of an existing Mother, Infant, and Early Childhood Home Visiting Program in 150     African American women in their early second trimester of pregnancy. The control arm, Parents     as Teachers, is an evidence-based approach to increase parental knowledge of child     development and improve parenting practices. The experimental arm, Parents as Teachers     Enhanced, builds on the Parents as Teachers curriculum by including nutrition and physical     activity components specifically designed for the gestational and postnatal periods. Both     arms of the intervention will be implemented by community-based, trained Parent Educators.     The comparative effectiveness of the two intervention arms on weight status, dietary intake,     and health behaviors of mothers and their infants will be assessed. The Delta Healthy Sprouts     Project will determine if a novel, scalable, lifestyle intervention can improve the health of     African American women and their children at high-risk for obesity and chronic disease.   "
117619|NCT01746381|"     Home non-invasive ventilation (NIV) is the standard-of-care as initial therapy for patients     with ALS with worsening symptoms or deteriorating respiratory function, and has been     recommended by the American Academy of Neurology (AAN) practice parameter for ALS.      This study will compare the current standard BiST mode of ventilation with the new iVAPS     mode. The main study hypothesis is that the iVAPS mode, initiated in a single daytime trial,     will result in a reduction of the number of respiratory therapist interventions and changes     in ventilator settings as compared with the standard BiST mode. This will be assessed over a     period of one year. In addition this study will test whether the iVAPS mode is superior to     BiST mode with respect to: comfort and ease of use; improvement in nighttime and daytime     symptoms of hypoventilation; compliance (hours used per day); physiologic parameters (daytime     and overnight oxygen saturation and transcutaneous CO2 level).   "
117735|NCT01744860|"     This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house     methods used in molecular laboratories for the assessment of the BRAF mutation status in     melanoma tumor samples. No patients will be enrolled in this study. Data will be collected     for approximately 6 months.   "
117620|NCT01746368|"     Objectives: The objectives of the pilot study were to (1) test the feasibility of     recruitment, randomization, and retention; (2) test the feasibility of a standardized     Nurse-Supported Advance Care Planning Intervention; (3) evaluate the feasibility of the     assessment process and data collection procedures; (4) evaluate the Veterans' satisfaction     with the intervention and their Advance Directive decisions; and (5) evaluate preliminary     effects of the Nurse-Supported Advance Care Planning Intervention.      Research Design: This was a prospective, randomized, controlled, unblinded pilot study.     Alabama Veterans who received care through the Tuscaloosa VA Medical Center were randomized     to either the Nurse-Supported Advance Care Planning Intervention or Care-as-Usual in a 2:1     ratio respectively. Data related to recruitment, randomization, and retention; study     completion by subjects; completeness of data collection; Veterans' satisfaction; and     preliminary effects of the intervention were collected, analyzed, and evaluated. The length     of the study was one year.      Methods: The setting for the study was Tuscaloosa VA Medical Center care sites. A convenience     sample of fifty subjects was recruited from Tuscaloosa VA outpatient clinics including Selma,     residential settings, Home Based Primary Care, and the Mobile Health Unit. The level of care     of subjects was all-inclusive, excepting current Hospice or Palliative Care. Selection     procedures included self-referral and referral by Tuscaloosa VA Medical Center staff. Entry     requirements were the meeting of all inclusion criteria and verification of no exclusion     criteria. The Nurse-Supported Advance Care Planning Intervention was a manualized education,     support, and guidance session provided by a Registered Nurse that included information about     risks, benefits, and alternatives of specific choices. The Care-as-Usual was a session with     the social worker who explained what the Advance Directive is, and guided the Veteran     regarding the process of completing the Advance Directive document, without providing     information about risks, benefits, and alternatives of specific choices. Study enrollment     period was six months. The primary study outcome measure was Advance Directive completion     rate. This pilot was not a hypothesis testing study. The underlying hypothesis of the     eventual full study is that the Nurse-Supported Advance Care Planning Intervention is     associated with Advance Directive completion rates at least comparable to that of the     As-Usual care.      Significance: This study supports the Veterans Health Administration (VHA) mission to provide     Veteran-centered care. It provides important information needed to plan a full study of the     effectiveness of a specific Nurse-Supported Advance Care Planning Intervention to facilitate     Advance Directive completion by rural Alabama Veterans.   "
117621|NCT01746355|"     Atypical Facial Pain is a chronic condition and presents controversies during diagnostic and     treatment, between specialist not have consensus about the pathophysiology. It is possible     consider this entitie a potential neuropathic cause without pathological signs. It knows the     repetitive transcranial magnetic presents good results in the treatment of chronic pain     coditions. The aim this study is evaluated the thresholds and excitability cortical in     patients with AFP and verify the patterns of improvement in pain for patients undergoing rTMS     compared to controls, as well as the therapeutic response to neuromodulation procedures. This     enroll 20 patients with DAF and 20 controls treated with rTMS (5 sessions) and evaluated     through questionnaires (EDOF clinical record, McGill Pain Questionnaire, Visual Analogue     Scale, Inventory of symptoms of neuropathic pain, neuropathic pain DN4 questionnaire, SF -36,     brief pain inventory). At the end of the data will be statistically analyzed and expressed as     mean and standard deviation, and analyzed by Student's t test, analysis of variance (ANOVA),     Tukey-Kramer and Pearson correlation. The level of significance is 5%. The results will be     published in journals indexed in the area both nationally and internationally and presented     at conferences and scientific meetings.   "
117622|NCT01746342|"     Fatigue is highly prevalent among multiple sclerosis (MS) patients and has pervasive adverse     effects on daily functioning and quality of life. The investigators found in a recent study     that obstructive sleep apnea-hypopnea (OSAH) is the most common sleep abnormality in multiple     sclerosis (MS) patients. There was also a significant relationship between OSAH and higher     fatigue scores in MS patients. Preliminary work from the investigators in this group of     subjects shows that treatment of sleep disorders (mostly OSAH) can improve fatigue and other     symptoms in some MS patients. However, it is now necessary to systemically test the effect of     OSAH treatment in a randomized, controlled study, to be sure that it really does improve     fatigue and other symptoms. The best treatment for OSAH in the general population is     continuous positive airway pressure (CPAP). This treatment has been well tolerated by most MS     patients who have used the device at the investigators' center. This project will therefore     be a randomized, controlled, clinical trial of CPAP in MS patients with OSAH. The effects of     six months of CPAP treatment on fatigue as well as sleep quality, somnolence, pain,     disability, and quality of life will be studied.   "
117623|NCT01746329|"     In the present study, muscle perfusion will be studied before and after an oral glucose     challenge following a fasting period.   "
117624|NCT01746303|"     The aim of this study is to determine the efficacy of 6 months' dietary supplementation with     omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older     adults. The effects of each of these interventions alone will also be assessed in order to     determine whether the combined treatment confers synergistic or additive benefit relative to     the effect of each therapy.   "
117716|NCT01745107|"     The purpose of this study is to determine the efficacy of preventive intensity modulated     radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous     cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.   "
117717|NCT01745094|"     The purpose of this study is to evaluate the safety and efficacy of concomitant use of     mirabegron in patients with overactive bladder under treatment with solifenacin.   "
117625|NCT01746290|"     Sudden cardiac arrest occurs when someone's heart stops beating unexpectedly. Each year,     more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve     survival: Call 911,start chest compressions and apply a defibrillator. Together, these     actions can increase survival by up to 800%. The problem is that bystanders to cardiac arrest     only provide CPR in about 3 of every 10 cardiac arrest cases and AED use in about 3 of every     100 cardiac arrest cases. There are many people in the community who are trained and willing     to provide help for cardiac arrest victims such as off-duty paramedics, fire fighters,     nurses, etc. When a cardiac arrest occurs in the city, it is likely that one of these people     is nearby, but unaware of the emergency. The PulsePoint smartphone application enables these     people to be notified by the local emergency 911 service when there is a cardiac arrest near     to them. It can be freely downloaded to several common types of smartphones. When there is a     cardiac arrest emergency, all nearby PulsePoint users are sent an alert from the 911 service.     When the phones receive the alert, they ring, vibrate and display a text message saying CPR     NEEDED. The user's current location and the exact location of the cardiac arrest are then     displayed on a map. Nearby public access AEDs are also indicated on the map. The smartphone     users can then go to provide chest compressions and use an AED while paramedics are on their     way. A video at www.pulsepoint.org shows how this works. The objective of the investigators     is to measure whether the PulsePoint smartphone application increases bystander CPR or AED     use for victims of cardiac arrest outside the hospital. This project will happen in the City     of Toronto. The investigators have a plan to get as many people as possible to download the     application, focusing on health care professionals who know CPR. The investigators will set     up a webpage that helps people download the software to their phone. The investigators will     randomize 911 calls to have a PulsePoint alert sent or not. The investigators will use     statistical analysis to measure whether sending an alert to a smartphone increases the     chances of bystander resuscitation.   "
117626|NCT01746277|"     There are two different treatment modes for NSCLC patients who failed to epidermal growth     factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI.     One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by     EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So     this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two     different treatment modes.   "
135505|NCT01511159|"     This trial is conducted in Europe. The aim of this trial is to determine the relative     bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when     injected under the skin.   "
117629|NCT01746238|"     The main purpose of this study is to test the safety, tolerability, maximum tolerated dose,     and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy.      Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to     subjects with sarcoma who are enrolled in this research study and may only be administered     under the direction of doctors who are investigators in this research study.      This study is being done because sarcomas can recur after surgical resection (surgery for     removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the     same location as the original tumor or in distant sites such as the lung. Thus better     treatments are needed.      This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational drug, combination of drugs, or combination of drugs with radiation. Phase     I studies also try to define the appropriate dose of the investigational drug to use for     further studies. Investigational means that the combination of drugs and radiation is still     being studied and that research doctors are trying to find out more about it. It also means     that the FDA has not approved bevacizumab with doxorubicin and radiation for your type of     cancer.   "
117630|NCT01746225|"     Longer first line chemotherapy duration has recently been associated with a modest, but     significant improvement in overall survival and a clinically meaningful and statistically     significant improvement in progression-free survival, in metastatic breast cancer patients.     Prolonging chemotherapy until disease progression, however, must be weighed against the     detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the     tolerability of prolonged chemotherapy administration strategy by studying alternative     treatment schedules, while preserving and possibly improving treatment efficacy in this     disease setting.      The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®),     represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an     attempt to reduce the toxicity associated with standard taxane administration (caused by the     use of chemical solvents) while increasing antitumor efficacy.      The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged     chemotherapy administration strategy. Each of three arms will be compared to a historical     reference of seven-month median progression-free survival (PFS) based on the most recent     trial with docetaxel as control arm to determine whether any of the three arms are worthy of     further investigation.   "
117631|NCT01746212|"     The purpose of this study is to report the radiographic, clinical, and functional outcomes of     a consecutive series of patients diagnosed with single or bilateral degenerative disc disease     between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF),     anterior only surgical approach, and InQu Bone Graft Extender and Substitute for bony fusion     and instrumentation.      Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery [a     surgical procedure that joins two or more lumbar vertebrae (small bones of the spine)     together into one solid bony structure by approaching the spine through the abdomen (front of     the body) and placing a bone graft in between the vertebral bodies where the disc usually     lies], are invited to participate in an orthopaedic research study.      This study will compare patients that have been treated with an anterior lumbar interbody     fusion using InQu Bone Graft Extender & Substitute to published data for a stand alone spinal     fusion surgery, where InFuse bone graft is placed between the transverse processes [small     bony projections off the right and left side of each bone in your spine] of the affected     vertebrae.      X-rays, daily activities, and how patients are doing will be evaluated at specific time     points during this study.      The hypothesis of this study is that patients diagnosed with degenerative disc disease     treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision     through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented fixation     have comparable radiographic (x-rays), functional (daily activities), and clinical (how the     patient is doing) outcomes when compared to published data for use of InFuse in stand-alone     fusion.   "
117632|NCT01746199|"     Given the resistance emergence of malaria in pregnant women receiving intermittent preventive     treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among     pregnant women infected by HIV it is urgent to seek a more effective alternative treatment to     optimize the prevention of malaria. Cotrimoxazole (CTM), actually administered daily as a     prophylactic mean to opportunistic infections for HIV infected patients, showed encouraging     results in preventing malaria in pregnant women. However, these results must be confirmed by     randomized trials, particularly in pregnant women.      The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM),     administered once daily with IPT-SP (3 curative doses spaced one month) on placental     parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) > 350     cells/mm3.      The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP     for placental parasitaemia. This might be due to the higher plasma concentration of     cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could be     recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell count.     In this study, the investigators will also test the hypothesis that the strains of Plasmodium     falciparum isolated from HIV-positive pregnant women express more dhfr and dhps resistance     markers.   "
117633|NCT01746186|"     The purpose of this study if to determine the specific contributions of energy intake and     energy expenditure to changes in body weight and fat.   "
117634|NCT01746173|"     The current standard of care for the frontline treatment of peripheral T-cell lymphomas     (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT).     However, many patients are unable to get to ASCT or relapse after ASCT, with a poor     prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan     (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore     designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the     results of a phase 2 study of this regimen in patients with PTCL.   "
117637|NCT01746134|"     This study is a disease-based registry designed to follow patients with a DSM-IV-TR     (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of     schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care     settings for up to 5 years. The registry seeks to describe the course of disease in     schizophrenia, including cognitive function and negative symptoms, its treatment, and its     burden of disease for participants, caregivers, clinicians, and society as a whole.   "
117638|NCT01746121|"     Amelogenesis Imperfecta (AI) are a heterogeneous group of rare genetic diseases transmitted     according to various mode of inheritance (X-linked, autosomal dominant, autosomal recessive)     affecting the formation/mineralization of tooth enamel. These diseases exist in isolation     with clinical manifestations limited to the oral cavity or may be associated to other     symptoms in syndromes. Many different genes (AMELX, ENAM, ENAMELYSIN or MMP20, KLK4, DLX3,     FAM83H, FAM20A WDR72…) coding for enamel matrix proteins, enamel matrix degrading proteins,     proteins involved in hydroxyapatite formation and growth and mineralization processes have     been discovered responsible for the clinical phenotypes (hypoplastic, hypomineralized,     hypomature) encountered in AI.      Genes involved in enamel formation but not yet identified in association with any form of AI     include: AMELY, AMELOBLASTIN, TUFTELIN, AMELOTIN, A Pin protein, ODAM (Odontogenic ameloblast     associated).      In this research protocol the investigators explore the phenotype including the enamel     ultrastructure and the genotype of a cohort of patients presenting AI.   "
117639|NCT01746108|"     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK     Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having     asplenia, splenic dysfunction or complement deficiencies.      In addition, this study will include an age-matched control group of healthy children aged     24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in     the at-risk population to that of the general, healthy population one month after each     pneumococcal vaccination.   "
117640|NCT01746095|"     The purpose of this study is to determine whether AeroVanc treatment is safe and effective in     reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.   "
117641|NCT01746082|"     This is a Phase II open-label study in approximately 200, and up to 240, healthy males and     non-pregnant females, aged 18 years and older. This study is designed to assess the safety,     reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated     influenza H3N2v vaccine manufactured by Sanofi Pasteur. Subjects will be stratified by age     (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120)     subjects >/= 65 years old) to receive two doses of vaccine, delivered intramuscularly as     15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be     approximately 7 months.   "
117901|NCT01742702|"     The primary aim of the present study was to examine the haemodynamic changes in primary     hypertension and secondary hypertension (renal diseases, endocrine diseases,     obesity-associated hypertension) with a non-invasive haemodynamic measurement protocol     utilizing radial pulse wave analysis and whole-body impedance cardiography in both supine     position and during head-up tilt. For comparison, haemodynamics of subjects with chronic     fatigue syndrome will also be recorded.   "
117642|NCT01746069|"     Smoking remains a major risk factor for chronic diseases and is a real problem for health     systems. The use of emerging technologies, such as mobile phone , may have a important role     in smoking cessation programs through sending reinforcement messages when patients quits     smoking.      Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation     program including health advice provided by a doctor and sending support messages to mobile     phone of patients.      Methods: Study design: Randomized single blind clinical trial. Study population: Patients     over 18 who are willing to start a smoking cessation program, who have mobile phone, who are     able to receive and send messages, and who have a score greater than 5 or equal to 5 on the     Richmond scale.      Sample size: 160 patients per arm to detect a difference in the percentage of smoking     cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group:     Health advice and support messages to mobile phone patients.      Control group: Health advice. Assessment of the primary endpoint: At 6 months     (positive/negative coximetry test).      Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry     test) will be performed using logistic regression.   "
117643|NCT01746056|"     The goal of this study is to determine the safety and efficacy of the occlusive heat patch     for the treatment of verrucae (warts).   "
117644|NCT01746043|"     The goal of this clinical research study is to compare armodafinil and minocycline when given     alone or in combination to learn which is better for controlling side effects of     chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack     of appetite, and drowsiness).      Armodafinil is designed to prevent excessive sleepiness.      Minocycline is an antibiotic, which may help to reduce multiple symptoms.      In this study, you may receive a placebo. A placebo is not a drug. It looks like the study     drug but is not designed to treat any disease or illness. It is designed to be compared with     a study drug to learn if the study drug has any real effect.   "
117645|NCT01746030|"     This study will evaluate the prevalence of geriatric syndromes in older adults with multiple     myeloma, examine relationships between baseline geriatrics syndromes and initial treatment     selection, and examine risk of functional decline.      Relationship between baseline geriatric questionnaires and initial treatment selection in     older adults with newly diagnosed multiple myeloma.      Feasibility of subjects completing the CARG geriatric assessments at baseline, 3 months and 6     months.      Comorbidities or dependence in IADLs at baseline predict decline in functional status at 6     months of follow-up in older adults with newly diagnosed multiple myeloma.   "
117646|NCT01746017|"     The aim of this trial is to evaluate the safety of the study drug in healthy people and     people with diabetes. It will investigate how much of the study drug gets into the blood     stream and how long it takes the body to get rid of it. Information about any side effects     that may occur will also be collected.      The study consists of two parts. Part A will study healthy participants in up to 4 dosing     periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3     dosing periods over approximately 5 weeks.   "
117647|NCT01746004|"     This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate     in healthy participants. The study will determine how the body eliminates the radioactivity     and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal     females, or sterile males. This study is approximately 8 to 15 days.   "
117660|NCT01745835|"     comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in     two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy     preparation.   "
117648|NCT01745991|"     The investigators plan to invite all children in the UK with biliary atresia, treated at the     three national centres (Birmingham, Kings College and Leeds), over a three year period to     take part in a randomised control study. The investigators aim to determine the effectiveness     of CoSeal® Surgical Sealant (an anti-adhesive agent) in reducing intra-abdominal adhesions     (scar tissue) and the morbidity caused by these adhesions in children treated with a Kasai     hepatoportoenterostomy. Adhesions are common, if not invariable, after any abdominal surgery.     They cause intra-abdominal organs to become stuck to each other and the abdominal wall. This     means they are no longer completely free to slide over each other. In particular patients     have a lifetime risk that the bowel can become kinked or twisted leading to complications     such as bowel obstruction. Adhesions also make repeat abdominal operations more difficult.     The adhesions have to be divided in order to separate the organs from each other and the     abdominal wall. This can lead to blood loss and increases the risk of damage to these organs.     Anti-adhesive agents have been created to reduce the severity of these adhesions, but there     is little in the medical literature to evaluate their effectiveness, particularly in     children. Biliary atresia is an obliterative obstruction of the bile ducts that occurs in     infants. Initially they are treated by an abdominal operation called a Kasai portoenterostomy     to restore bile flow from the liver to the intestines. However approximately 40% of these     children will go on to require a liver transplant operation in the first two years of life.     If CoSeal® Surgical Sealant is effective this could reduce the patients lifetime risk of     complications from abdominal adhesions and also facilitate repeat abdominal operations for     these children, in particular for those who go on to require a liver transplant.   "
117649|NCT01745978|"     The aim of the present study was to compare the efficacy and safety of the knob-tipped knife     and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.   "
117650|NCT01745965|"     Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone     receptors(ER and/or PR) breast cancer (HEr2+/HR+).      A new high potential trastuzumab conjugate T-DM1(trastuzumab was linked with the cytotoxic     agent mertansine DM1)was tested with endocrine therapy and without against a standard arm     with trastuzumab and endocrine therapy.   "
117651|NCT01745952|"     The investigators will treat patients with fully characterized refractory unifocal     neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic     stimulation, TMS) to the region that causes the epilepsy. Active rTMS applied over the     epileptogenic focus will reduce seizure frequency compared with sham rTMS.   "
117652|NCT01745939|"     The purpose of this study is to understand how different physical therapy interventions     affect the use of certain abdominal muscles in patients with low back pain.   "
117653|NCT01745926|"     Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in     cardiac arrest patients and is fundamental for the neurological outcome and survival of these     individuals. Unfortunately, the quality of CPR may be inadequate due largely to ineffective     chest compressions resulting from rescuer fatigue and interruptions in compressions. The     LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund, Sweden),     introduced in 2002, is the most extensively tested and applied automated alternative to     manual CPR for in-hospital care of cardiac arrest patients and during ambulance transfer; the     feasibility of application of this device in helicopter emergency medical service (HEMS)     operations, however, has never been addressed. The objective of this project is to equip the     three active rescue helicopters in South Tyrol with the LUCAS 2 mechanical chest compression     device to answer the question: What is the feasibility and efficiency of using this device     for prolonged CPR in cardiac arrest patients requiring CPR during HEMS rescue operations and     transport?   "
117654|NCT01745913|"     The purpose of this study is compare the efficacy of haplo-cord transplant (investigational     arm) with that of a more commonly used procedure in which only the cells contained in one or     two umbilical cords are infused (standard arm).      We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast     engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus     host disease, low frequency of delayed opportunistic infections, reduced transfusion     requirements, shortened length of hospital stay and promising long term outcomes. We also     hypothesize that umbilical cord blood selection can prioritize matching and better matched     donors can be identified rapidly for most subjects.   "
117655|NCT01745900|"     Comparison of noninvasive glucose measurement performance versus standard invasive reference     measurements.   "
117656|NCT01745887|"     This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled,     parallel-group study designed to evaluate the safety and biological activity of two doses of     EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye     Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9     centers located in the United States (US). Subjects will be enrolled in two groups or     cohorts. The first enrollment group will consist of 33 subjects.   "
117657|NCT01745874|"     The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is     superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of     rectal cancer.   "
117658|NCT01745861|"     The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent     reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this     figure is more than double the highest previous estimated incidence. In the majority of     patients the condition is mild, but about 25% of patients suffer a severe attack and between     30 and 50% of these patients dies. The usual cause of death is multiple organ failure     secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic     inflammatory response syndrome (SIRS).      Studies with omega-3 fish oil have shown to control inflammatory process and improve the     outcome especially in hyperinflammatory conditions.      This research will look at the effects of supplementing omega-3 fish oil to patients with     severe acute pancreatitis (severe inflammation of the pancreas).      Patients with severe acute pancreatitis will be prospectively and blindly randomised into     either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids     and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion     contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical     care will be provided to all patients as per the national management guidelines. Each patient     will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for     discharge by their own medical team or for a maximum of SEVEN days.      The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish     oil could improve the clinical outcome in patients with severe acute pancreatitis.   "
117659|NCT01745848|"     Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease     surrogate markers of bone metabolism and early cardiovascular disease in individuals with     moderate to severe airflow obstruction and a chronic bronchitis phenotype.   "
117683|NCT01745536|"     This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.   "
117661|NCT01745822|"     Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In     Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of     perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma,     even if her infant receive specific immunoglobulin and vaccine.      The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in     HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant     women participating in this study will receive tenofovir or placebo during the last trimester     of pregnancy and two months postpartum. The risk of perinatal transmission will be compared     between the two groups.      The results of the study will help define policy to manage HBV infected pregnant women to     prevent perinatal transmission.   "
117662|NCT01745809|"     The purpose of this research study is to collect lung tissue and fluid from two groups of     people: those who have severe asthma, and those who do not. These samples will then be tested     in a laboratory to identify differences in the lung tissue cells and fluids that may exist     between these two groups of people.   "
117663|NCT01745796|"     Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its     increasing resistance to antibiotics requires the development of new strategies for     prevention and control, demanding a better understanding of the modes of transmission and     evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation,     the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination     (endogenous, crossed transmission between patients, or environmental origin) of varying     importance, mainly depending on the endemic situation of the place of study.      The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of     molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative     techniques, the investigators wish to study the impact of the mode of contamination on the     outcome of ICU patients, intubated and ventilated for more than 72 hours.   "
117664|NCT01745783|"     This is a phase I / II for the evaluation of the safety and feasibility of intravenous     infusion of mesenchymal cells from autologous bone marrow in patients with Multiple     Sclerosis.      Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and     safe and can be effective in treating patients suffering from multiple sclerosis.   "
117665|NCT01745770|"     The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x     500 mg mesalazine in the treatment of patients with acute ulcerative colitis   "
117718|NCT01745081|"     Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and     intensive care settings. More recent data indicate that hypertonic saline may be as effective     or more effective than mannitol for this purpose, with possible fewer side effects.      This study compares both agents in favoring cerebral relaxation during elective     supratentorial procedures for tumor resection.      Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer     side effects than 20% mannitol.   "
117666|NCT01745757|"     Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first-     and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS     in the individual studies currently reported. In Europe, EMEA has maintained its indication     associated with weekly paclitaxel in first line metastatic breast cancer and more recently     with capecitabine based on RIBBON 1 trial's results.      The identification of patient subsets that receive the most clinical benefit would enable     more specific treatment administration of bevacizumab and allow patients unlikely to benefit     the opportunity to seek other treatment modalities. Unfortunately, despite efforts to     identify patient subsets with a differential benefit from bevacizumab, no validated     biomarkers have been defined.      The Avastin cohort is a unique opportunity to investigate various biological and imaging     parameters which could be related to clinical benefit of the combination of bevacizumab and     weekly paclitaxel in first line MBC in a homogeneously treated population in French cancer     centers. This trial will gather the expertise of several translational research platforms of     different cancer centers from the UNICANCER consortium.   "
117667|NCT01745744|"     Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups     controlled by two levels of dose to assess the safety and feasibility of the infusion of     mesenchymal stem cells from adipose tissue administered intra-arterially in nondiabetic     patients with chronic ischemia of lower limbs (CLI) and no possibility of revascularization.   "
117668|NCT01745731|"     This is a randomized controlled trial in which the safety and feasibility of cell therapy     medicinal product shall be measured by comparing the variables of the response after     treatment compared to baseline prior to implementation. Secondarily the results obtained are     compared with each of the study groups.      Patients will receive concomitant basic pharmacological treatment for maintaining liver     function.      All patients will be equally medically treated. The hypothetic test is to propose mononuclear     cells from the bone marrow infused in the territory hepatic portal remaining segments (II and     III) to be performed while contralateral portal embolization provides progenitor cells     hepatic regenerative capacity that would shorten the time of liver regeneration and increase     residual volume, facilitating the realization of an extended hepatectomy with greater     assurance of maintaining proper residual function and adequate surgical margins.   "
117669|NCT01745718|"     The investigators will evaluate the accuracy of performing cytological imprints of targeted     biopsies when diagnosing prostate cancer.      It is useful to know whether the biopsy is cancer or not, in order to know when to stop     sampling and when to continue.      The strategy is used in other types of cancer, e.g lung, breast etc   "
117670|NCT01745705|"     Cervical spine manipulation (CSM) is utilized by many health care practitioners in the     management of patients with neck pain and headache. How CSM works is not understood however,     most researchers agree that there is likely a combination of mechanical, neurophysiological     and placebo effects. This study will test for possible neurophysiological effects by     examining for changes in a person's ability to reposition their head and neck in space, and     maintain their balance following CSM.   "
117684|NCT01745523|"     This study is aimed to evaluate the use of Hydroxypropyl Cellulose (HPC) as substitute for     the traditional protein supplement (Synthetic Serum Substitute; SSS) and Trehalose as     substitute for the most widely used sugar (Sucrose) in the vitrification solutions employed     for oocyte vitrification.   "
117671|NCT01745692|"     Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot)     can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore     the blood supply and limit the damage, resulting in an increased proportion of people making     a recovery to independence after stroke. However, drug treatment only succeed in restoring     blood flow in a minority of people with clots in the larger arteries (10-25% depending on the     size of the blood vessel) and these people also have the most severe strokes and highest risk     of death or dependence as a result of the stroke. Current best treatment is therefore least     effective in the group with the most severe strokes. Devices that can be fed through the     blood vessels to either remove or break up the blood clot in the brain vessels can open this     type of large artery blockage. However, using these devices is a highly skilled procedure and     it takes some time both to set up the necessary facilities (including anaesthetic, nurses and     medical support) and to reach the blockage. The extra time that is required to use these     devices may mean that brain tissue is already irreversibly damaged. If so, then an individual     patient cannot benefit and indeed may be harmed by opening the artery. There are no completed     clinical trials comparing the outcome in people treated with standard stroke treatment and     those treated with devices. PISTE is a randomised, controlled trial to test whether     additional mechanical thrombectomy device treatment improves functional outcome in patients     with large artery occlusion who are given IV thrombolytic drug treatment as standard care.   "
117672|NCT01745679|"     The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in     patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this     population. Additionally, we aimed to detect adverse effect, especially neurological trouble     related to Ceftriaxone toxicity.   "
117673|NCT01745666|"     The aim of the study is to evaluate the best stress exam to unmask long QT in patient with     KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.   "
117674|NCT01745653|"     Thus study consists of evaluating the effect of low level therapy on pain induced by     insertion of an orthodontic device (the quadhelix). Each day during the first seven days     post procedure, the level of pain will be reported on an analogic visual scale.      As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will     also be daily registered.   "
117675|NCT01745640|"     The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide     and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or     translocation (4;14)   "
117676|NCT01745627|"     Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign     pigmented and vascular lesions and scars   "
117677|NCT01745614|"     The objective of this study was to confirm if two formulations of nimesulide tablets are     bioequivalent.      Test product was Eskaflam® (Nimesulide 100 mg tablets; GlaxoSmithKline) and reference product     Mesulid® (Nimesulide 100 mg tablets; Syntex for Productos Roche). The single dosage was one     tablet.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 28 healthy volunteers, both genders, adults between 18-40     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
117678|NCT01745601|"     The objective of this study was to confirm if two formulations of escitalopram tablets are     bioequivalent.      Test product was escitalopram (10 mg; GlaxoSmithKline) and reference product Lexapro® (10 mg     escitalopram; Lundbeck). The single dosage was one tablet.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 26 healthy volunteers, male adults between 18-50 years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
117679|NCT01745588|"     The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the     number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in     patients with myeloma. To do this, the investigators want to compare two types of treatment     using pomalidomde. This is a randomized trial which means that the decision as to which     treatment the patient will receive will be made by a computer, much like flipping a coin.      All patients start by receiving 4 cycles of clarithromycin, pomalidomide and dexamethasone     (ClaPD). After 4 cycles, half of the patients will undergo an autologous stem cell transplant     followed by pomalidomide (Group 1). The other half of the patients will continue to receive     ClaPD for 9 cycles to be followed by pomalidomide maintenance. (Group 2).      At the end of the study, the two groups will be compared to see if there is a difference in     disease outcome.   "
117680|NCT01745575|"     The objective of this study was to confirm if two formulations of alprazolam (tablets) are     bioequivalent.      Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg     (Pharmacia & Upjohn). One tablet was the single dosage.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 26 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
117681|NCT01745562|"     The objective of this study was to confirm if two formulations of alprazolam (tablets) are     bioequivalent.      Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg     (Pharmacia & Upjohn). One tablet was the single dosage.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 28 healthy volunteers, both genders, adults between 18-50     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
117682|NCT01745549|"     During the last years, even more little needles are used for the injection of sub cutaneous     insulin, for the diabetes therapy.      The aim of this study is to evaluate the non inferiority of a new needle, smaller than     another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.   "
117685|NCT01745510|"     -  The purpose of this study is to determine whether docosahexaenoic acid is effective in          the prevention or reducing severity of necrotizing enterocolitis (NEC) in preterm          neonates < 1500 g at birth who are starting enteral feeding.        -  if NEC is prevented, this study will measure whether hospital stay is also reduced in          neonates who receive Docosahexaenoic acid (DHA)   "
117686|NCT01745497|"     Autism Spectrum Disorders (ASD) are characterized by difficulties in language, social     communication, and repetitive and restricted behaviors. ASD affects as many as 1 in 90-150     children. Sleep issues/insomnia is very common in children with ASD (50-80%). Insomnia has a     negative impact on both the developmental and behavioral function of the child and the     quality of life for the family. Causes of insomnia in children with ASD are multifactorial     and can be difficult to treat effectively. Low iron stores, as manifest by low serum ferritin     levels, is also common in children with ASD. Both insomnia and low iron stores are associated     with Restless Legs Syndrome (RLS) and Periodic Limb Movement of Sleep (PLMS). Children with     ASD often have difficulty communicating symptoms or tolerating Polysomnography (Sleep Study).     This makes establishing a diagnosis of RLS or PLMS very difficult in children with ASD.   "
117687|NCT01745484|"     Overall objective of the study is to compare the use of SPECT in radiotherapy treatment     planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer     patients   "
117688|NCT01745471|"     The purpose of this study is to collect data to help understand why some women develop     Polycystic Ovary Syndrome (PCOS) associated with decreased lower-body fat.   "
117689|NCT01745458|"     This study is designed to assess whether inhibition of plasma Lp-PLA2 activity impacts     platelet function as assessed by ex vivo platelet aggregation tests and in vivo plasma     biomarkers.   "
117690|NCT01745445|"     This trial aims to evaluate the efficacy and safety between radiotherapy alone and concurrent     chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.   "
117691|NCT01745432|"     Adhesions are the most frequent complication of abdominopelvic surgery. They are internal     scar tissues which form as a result of surgery which may abnormally join together what were     once separate tissues and organs.      This study will assess the safety and usability of anti-adhesion agent (gel) when used after     laparoscopic surgery.      The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse     events in ADBLOCK and surgery only group) assessed at 28 days   "
117741|NCT01744782|"     This is a long-term, open-label study of the safety, tolerability and effectiveness of RP103     in cystinosis patients who are naïve to any form of cysteamine treatment. Subjects will     receive RP103 treatment for at least 12 months. US subjects will transition to the     commercially approved drug PROCYSBI®. In Brazil, after at least 12 months of study     participation and upon approval by the Brazilian regulatory authorities, subjects will be     eligible to transition to a post study drug supply program, and continue to receive the drug     at no personal cost.   "
117692|NCT01745419|"     Chronic obstructive pulmonary disease (COPD) is a common disease in smokers. COPD has a     slowly deteriorating course, punctuated by exacerbations- acute events characterized by     increasing shortness of breath and putrid sputum. Exacerbations of COPD may be precipitated     by several factors, most commonly infections.      Exacerbation frequency generally increases with declining lung function. However, some     patients with COPD consistently experience a higher rate of exacerbations than others despite     similar severity of COPD. This has led researchers to postulate the existence of a distinct     subgroup of frequent exacerbators . Recent work has also brought attention to a subset of     patients who experience remarkably few exacerbations despite significantly impaired lung     function. Careful characterization of both of these extreme subgroups of COPD may offer     additional insights into why certain patients are prone to frequent exacerbations while     others remain relatively protected.      Haptoglobin (Hp) is a protein produced predominately by the liver . In humans two types of     genes for Hp exist (1 and 2) with possible combinations of these two genes- 1-1, 1-2, or 2-2.     The Hp 2 gene is believed to have arisen from the Hp 1 gene in human evolution. Subsequently     the prevalence of the Hp 2 allele has spread throughout the world, probably as a result of     its ability to provide a selective advantage against infectious disease. The Hp 1-2     combination is a very common one. In most western countries, the prevalence of the Hp     genotypes is 16% Hp 1-1, 36% Hp 2-2 and 48% Hp 2-1.      The Hp gene form has been shown to be associated with disease. Specifically, Hp phenotypes     have been found to affect propensity to atherosclerosis in Diabetic individuals. There have     been several studies suggesting that the Hp 2-2 phenotype is associated with a protection     against infectious complications.      In view of the importance of respiratory infections on COPD exacerbations, and of the gained     knowledge of Haptoglobin subtypes on propensity to infection, we propose to investigate     whether Haptoglobin subtypes are in correlation with the frequent exacerbator phenotype of     COPD. We postulate that, since people with Hp 1-1 are more prone to infection, the frequency     of the Hp 1-1 phenotype will be higher in frequent exacerbators of COPD than in non-     exacerbators.      To test our hypothesis we propose to determine Hp phenotype in two groups of COPD patients:     one with frequent exacerbations and one with no exacerbations, and compare the relative     frequency of the 1-1 phenotype in the two groups.   "
117693|NCT01745406|"     When a patient is admitted to the ICU this often happens so suddenly that this can create a     significant amount of stress and anxiety for family members for several reasons. Firstly, the     family does not have a pre existing relationship with the ICU team. Secondly, the urgency of     the situation and the technic it requires is often such that minimal information can be given     to family members. And finally, as a result of the unpredictability of each patient's     condition, it can be difficult to predict outcome for family members. Together, these factors     compound the stress and anxiety of family members. This anxiety is natural and it is     important for health caregivers to be able to offer the best support possible. A high quality     communication provided by structured information given by physicians and nurses as well could     improve support to the families and lead to greater satisfaction.      Giving information to families during meetings is crucial at 3 moments: at the first day when     the patient is admitted, at day 3, weekly and each time important news is given (surgery,     deterioration in condition, end-of-life).      The purpose of this project is to evaluate if the involvement of nurses during those meetings     could improve quality in communication which is assessed by mixed methods. Families and     healthcare workers satisfaction will be assessed by qualitative methodology. Family     peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using     validated scales.      Training of healthcare workers will be done by role play. Information to the families is     delivered using a framework for physicians and nurses. All the meetings of the study will be     audited by a psychologist.   "
117694|NCT01745393|"     The study's primary aim is to test the hypothesis that an intervention integrating pediatric     clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result     in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and     reported cigarettes exposed/day than a clinic-level quality improvement plus attention     control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to     CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among     parents.   "
117696|NCT01745367|"     This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study     for subjects with locally recurrent or metastatic triple negative breast cancer.      Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or     placebo and weekly paclitaxel.      Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance     score (0 vs 1) and line of treatment (first vs second).      All subjects will be evaluated for progression free survival and overall survival as well as     safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in     study. This study will determine whether tivozanib hydrocholoride combined with weekly     paclitaxel improves clinical outcomes in patients with triple negative breast cancer.   "
117697|NCT01745354|"     For patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using     cells from a healthy donor represents potentially curative treatment. In these individuals,     cure is possible because transplantation of healthy donor immune cells can fight the lymphoma     in the patient. The goal of this work is to test a strategy that activates the healthy donor     immune cells so that they more effectively fight lymphoma and can result in an increased cure     rate for these patients. Our group has previously studied CpG, an immune activating     medication, in patients with lymphoma and demonstrated modest anti-tumor responses. We now     have a more potent form of CpG which we intend to test to see if it will better activate the     donor immune cells and result in shrinkage of tumor throughout the entire body, not just at     the injected site.   "
117698|NCT01745341|"     The purpose of this study is to determine if apnea (the stopping of breathing) occurs in     patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery   "
117699|NCT01745328|"     Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection     (RUTI).   "
117700|NCT01745315|"     There are many instruments with different energy modalities or with different properties that     are available for use in total laparoscopic hysterectomy. The aim of the present study is to     compare three of these instruments that are present in our clinic - HALO PKS Cutting Forceps,     LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect to     operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative     complications, return of gastrointestinal activity and hospitalization time.   "
117701|NCT01745302|"     The investigators performed a randomized, double-blind controlled, prospective study method     on observation of Traditional Chinese Medicine combined with targeted therapy to prolong the     efficacy of long-term survival of advanced pulmonary Adenocarcinoma patients.The     investigators plan to involve 404 cases for observation in 3 years (202 cases for each     group), expecting that integrated TCM combined with targeted therapy has a better efficacy on     prolonging progression-free survival time, overall survival, improving QOL of patients than     that of targeted therapy.   "
117702|NCT01745289|"     The LATTE study is an extension study to the now closed Arimidex, Tamoxifen Alone or in     combination (ATAC) trail that took place 10 years ago. LATTE aims to collect long term     follow-up information since the conclusion of ATAC, and for at least another 5 years,     regarding: Additional efficacy data (first local recurrence, first distant recurrence),     Additional safety data (ischaemic cardiac and cerebrovascular event, fractures), and Cause     specific mortality and new primary cancers.      The LATTE study will pick up where ATAC left off to follow a number of post-menopausal women     with breast cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC     Trial and not known to have died or withdrawn consent before April 1st 2009. Since ATAC was a     nationwide study, the women of LATTE will also reside and receive their follow-up care in     various areas of the country. There will not be any vulnerable groups participating in this     study.      Patient interaction will consist on in person interviews at designated follow-up times and/or     telephone interviews. Data will be collected at point of contact, whether that is in person     at the clinic site or over the telephone. Telephone interviews will be completed in LATTE     study offices. Topics of focus for data collection consists of: whether or not there is a     suspected recurrence, new breast primary tumour, new other primary tumour, ischaemic cardiac     event, cerebrovascular event, or a serious fracture. Since the follow-up questions are short     in detail, respondent burden time should be less than 1 hour in most cases.   "
117703|NCT01745276|"     The purpose of this study is to evaluate the relative osseomechanical strength of a novel     coated pin/screw in a clinical model.   "
117704|NCT01745263|"     The European population is aging rapidly which poses a challenge on the individual, the     European societies, and health care systems. Among the most promising public health     interventions that may extend healthy life expectancy at older age are vitamin D, marine     omega-3 fatty acids and physical exercise. However, their individual and combined effects     have yet to be confirmed in a clinical trial.      The broad aim of DO-HEALTH is to prolong healthy life expectancy in European seniors. The     specific aim is to establish whether vitamin D, omega-3 fatty acids, and a simple home     exercise program will prevent disease at older age.      To achieve these aims, DO-HEALTH will enroll 2152 community-dwelling men and women who are 70     years and older, an age when chronic diseases increase substantially. The DO-HEALTH seniors     will be recruited from 7 European cities (Zurich, Basel, Geneva, Toulouse, Berlin, Innsbruck     and Coimbra) and will be randomized in a 2x2x2 factorial design trial to a simple home     exercise program and/or vitamin D, and/or omega-3 fatty acids, over a 3 year period. This     will allow to test the individual and the combined benefit of the interventions in the     prevention of 5 primary endpoints: the risk of incident non-vertebral fractures; the risk of     functional decline; the risk of blood pressure increase; the risk of cognitive decline; and     the rate of any infection. Key secondary endpoints include risk of hip fracture, rate of     falls, pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and oral     health, quality of life, and life-expectancy.      All clinical endpoints will be supported by a large DO-HEALTH biomarker study to evaluate the     effect of the interventions at the cellular level of multi-organ function. DO-HEALTH will     further evaluate reasons why or why not seniors adhere to the 3 interventions, and will     assess their cost-benefit in a health economic model based on documented health care     utilization and observed incidence of chronic disease.      website DO-HEALTH: http://do-health.eu/wordpress/ website EC:     http://ec.europa.eu/research/health/medical-research/human-development-and-ageing/projects/do     -health_en.html   "
117705|NCT01745250|"     The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and     Juvederm Ultra smile   "
117706|NCT01745237|"     The primary objective of this study was to determine the ability of cardiac magnetic     resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were     to undergo CMR in addition to routine clinical evaluation.   "
117707|NCT01745224|"     This proof of concept study will be conducted to assess the aesthetic improvement in     refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q     Switched Nd: YAG Laser vs. Alex TriVantage   "
117708|NCT01745211|"     Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm     Alexandrite laser.   "
117710|NCT01745185|"     This study is a prospective active comparator study to assess the immune response elicited by     human recombinant agalsidase therapy in subjects who are switching from agalsidase alfa to     agalsidase beta with Fabry disease. Fabry disease is an X-linked lysosomal storage disorder,     due to deficient alpha-galactosidase A activity. The progressive accumulation of     globotriaosylceramide (GL-3) in the lysosomes of the vascular endothelial cells of multiple     organ systems like the kidneys, heart, skin, and brain, leads to a microvascular disease. In     Fabry disease, nephropathy dominates and renal function impairment occurs as a result of     accumulation of GL-3 in renal cells   "
117711|NCT01745172|"     This is a pilot study to assess the effectiveness, safety and feasibility of carotid body     removal in patients with high blood pressure (hypertension) resistant to medical treatment.     Patients with high blood pressure are at significant risk of medical complications including     stroke and heart disease. The principle research question is whether removal of the carotid     body will lead to an improvement in the blood pressure of this patient group.   "
117712|NCT01745159|"     To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend     remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric     patients over a period of 6 months.   "
117713|NCT01745146|"     The present study addresses problematic anger and irritability in community dwelling persons     with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment     approach called Anger Self-Management Training (ASMT), compared to a treatment offering     supportive therapy focused on personal readjustment and education, the PRE (Personal     Readjustment and Education). The project is a 3-center randomized controlled trial employing     equivalent therapist time and therapeutic structure in the delivery of treatment options. The     overall aim is to evaluate the relative response rate and correlates of treatment response     for the ASMT as compared to the PRE.   "
117714|NCT01745133|"     The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam     may help maintain the therapeutic benefit that is achieved with OLUX-E™ Foam in the     treatment of moderate plaque psoriasis.      OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation.     SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by     the FDA for treating plaque psoriasis.   "
117902|NCT01742689|"     In this study we will compare pain intensity and side effects at different time points after     the intranasal administration of desmopressin or placebo in patients with acute renal colic     pain.   "
117719|NCT01745068|"     During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will     experience at least one fracture due to bone fragility (FF). Evidence is growing regarding     prevention programs' effectiveness to prevent falls, but prevention of fractures through fall     prevention programs has enjoyed limited success. Falls prevention programs and post-fracture     screening programs leading to pharmacological treatment are very different strategies, with a     shared ultimate goal. Coordination between those who repair fractures and those who manage     the patient to prevent the next fracture is critical. The overarching aim of this proposal is     to generate evidence-based knowledge about the effectiveness and cost-effectiveness of an     integrated FF prevention program, as well as a portrait of the barriers and facilitating     factors for such programs. More specifically, the objectives are: 1) to combine existing fall     prevention and post-fracture management programs in the province of Quebec into integrated FF     prevention programs; 2) to compare the performance of these integrated programs to control     sites, using a pragmatic study design; 3) to identify barriers as well as factors that     improve effectiveness across different implementation milieu; and 4) to develop and engage in     active knowledge transfer activities in Quebec regions where integrated FF prevention     programs are neither adequately nor successfully implemented. Drawing upon the literature on     integrated healthcare, fall and fracture prevention, we hypothesize that an integrated FF     program can reduce the risk of a subsequent fracture by at least 30% in the population of     interest. The proposed team is poised to develop new interdisciplinary collaborations among     healthcare practitioners and decision makers involved in the prevention of FFs. The program     is built upon existing healthcare and structures and programs and in turn, will truly measure     the effectiveness of an integrated FF prevention program. The results will ultimately lead to     improvements in the existing knowledge base, address policy-relevant and health systems     problems, and assist in the design and implementation of FFs prevention programs.   "
117720|NCT01745055|"     This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics     (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate     the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and     tolerability of co-administration of CP-690,550 and MTX.   "
117721|NCT01745042|"     The purpose of this study is to investigate anthropometric, metabolic, cardiovascular and     symptomatic profiles in postmenopausal women.   "
117722|NCT01745029|"     The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering     from severe Ulcerative Colitis (UC) and to compare these results with similar results     obtained in remission.      The study is done with the use of Motilis 3D-Transit system which consists of a small     electronic capsule ingested and detected by a receiver carried by the patient. Position and     orientation of the capsule are interpreted by dedicated computer software and transit times,     progression velocity and contraction frequencies can be revealed.      The study is mainly descriptive and is designed to test and evaluate the usefulness of the     Motilis 3D Transit system in UC patients and to tell investigators more about GI motility     during and after severe inflammation.      Motilis 3D-Transit system gives investigators a unique chance to study the gastrointestinal     canal as a whole during and after severe illness.      The investigators expect to include 20 patients suffering from severe UC admitted to Hospital     with the purpose of getting medical treatment. The investigators do not expect any drop out,     but in case of drop out a new patient will be included.   "
117723|NCT01745016|"     Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle     buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the     effectiveness of beta-alanine supplementation. The physical working capacity test has been     used to show significant increases in physical working capacities following supplementation.     The physical working capacity tests were originally developed by Moritani et al. 1981 and     Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized     that beta-alanine will increase physical working capacity at heart rate threshold, thereby     signifying a delay in fatigue.   "
117736|NCT01744847|"     In patients with pancreatic duct cannulation initially by chance, double guide wire technique     and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar     success rates. The incidence of post-procedure pancreatitis was similar in the two groups,     but post-procedure hyperamylasemia was significantly higher in the DGT group.   "
117774|NCT01744353|"     The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which     consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and     abraxane. Each of these drugs are currently used in pancreatic cancer.      The experimental part of the study is combining these drugs together in FOLFOX-A.   "
117724|NCT01745003|"     The main goal of this Collaborative Proposal is to investigate biochemical, functional, and     structural neuroimaging changes following non-invasive brain stimulation in patients with     chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities     which focus on central mechanisms provide modest relief for these patients raises the     possibility that the cause for the chronicity of this debilitating disorder may lie within     the brain itself. We propose that changes in the cortical milieu may result from prolonged     experience of pain and suffering. Our previous results suggest changes in excitatory     neurotransmitter levels, connectivity between multiple brain networks, and cortical thickness     coincide within central neural loci related to pain perception and modulation in FM.     Interestingly, modulation of cortical activity can be achieved noninvasively by a novel tool,     transcranial direct current stimulation (tDCS), which has been reported to produce lasting     therapeutic effects in chronic pain, especially FM. We propose to study the long-term effects     of tDCS application on multiple levels of the central nervous system in FM patients. This     project has significant clinical relevance and has the support of collaborators from     University of Michigan and Harvard University   "
117725|NCT01744990|"     The aim of this study is to identify, based on standardized food provocation tests, which     nuts allergic patients need a selective, or a complete dietary eviction of all kind of nuts     (nuts being defined as peanut, all tree nuts, pine nut and sesame). The investigators     postulate that predictive factors of multiple nut allergy are high specific immunoglobulin E     level, positive skin tests and/or clinical markers, such as atopic dermatitis, presence of     other food allergies or a history of a severe previous reaction   "
117726|NCT01744977|"     The purpose of the overall study is to improve medication use rates among veterans by looking     at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve patients     who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their medications     based on how often they refilled their medications in the last 12 months.      The investigators will test an innovative adherence packaging relative to usual care. The     primary hypothesis is that veterans who receive the intervention will have greater     improvement in their medication adherence as measured by pill refill at 6 and 12 months of     follow up as compared to the control group.   "
117727|NCT01744964|"     The aims of this study were to assess the effects of the dopamine agonist apomorphine on     experimental pain models in healthy subjects and to explore the possible association between     these effects and a common polymorphism within the dopamine transporter gene.   "
117742|NCT01744769|"     1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant          number of them experience severe hypothyroidism in preparation for radioactive iodine          (RAI) therapy after total thyroidectomy.        2. Because the function of thyroid hormone is closely linked with lipid and glucose          metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may          induce the changes of metabolic parameters.        3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular          parameters during radioactive iodine therapy in differentiated thyroid cancer.   "
117728|NCT01744951|"     This study seeks to pilot a manualized adoption-specific intervention aimed at providing a     preventive intervention for families adopting children ages 5-14 years where family     reunification has been terminated and the family is moving toward adoption or who have     adopted children from foster care in the last three years. This work will fill a major gap in     services to children and families and is developed to improve mental health and family     functioning of children adopted from foster care, as well as decrease adoption disruptions.     President Clinton's 1997 adoption initiative, The Adoption and Safe Families ACT (ASFA),     along with subsequent Congressional initiatives, have provided incentives to States and     subsidies for adopting older children with a resultant increase in rates of adoption from     foster care from 26,000 in 1995 to 53,000 (stabilized annual rate) beginning in 2002. The     mean age at adoption from foster care is now 6 years old. These older children have histories     of physical and sexual abuse, neglect, and multiple placements, all factors that predict     behavior problems over time. To address this gap in our knowledge of providing care for this     vulnerable group, we have developed a manualized adoption-specific intervention for families     adopting children from foster care. Because adoptive children generally enter homes with     stable, well-functioning parents, interventions may be particularly effective in helping the     children adjust and their parents learn to understand and manage children with difficult past     histories.      The aim of this current pilot trial is to test this intervention designed to improve the     outcomes for children adopted from foster care through a randomized trial. Our hypothesis is     that this manualized adoption-specific intervention will be more effective than care as usual     in improving child mental health and family functioning outcomes; specifically, families and     children who have been randomized to the manualized adoption-specific intervention will show     better outcomes on the post-treatment measures and the 3 month follow-up than on the     pre-treatment measures than the care as usual families and children.   "
117729|NCT01744938|"     Patients with the lower malignant obstructive jaundice planned to do the     pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without     preoperative biliary drainage), both groups has the similar surgical morbidity, no statistics     significance.   "
117730|NCT01744925|"     This study is designed to evaluate the safety and efficacy of icotinib at routine dose and     higher dose as second-line treatment in non-small cell lung cancer patients with epidermal     growth factor receptor of wild type.   "
117731|NCT01744912|"     The purpose of this study is to determine whether ublituximab in combination with     lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies     who have relapsed or are refractory after CD20 directed antibody therapy   "
117732|NCT01744899|"     The purpose of this study was to examine the effect of prolonged sitting duration and three     different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve     root function by measuring the soleus (SOL) H-reflex amplitude. In addition, the pressure     under the ischial tuberosities during the three sitting postures were assessed and correlated     with the SOL H-reflex amplitude.   "
117733|NCT01744886|"     One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has     been discussed in multiple studies. Literature shows different ventilation strategies and     possible hypoxemia has been attributed to several issues.      Port-access cardiac surgical procedures (key hole surgery including mitral valve repair or     prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a     combination of these) require the use of OLV as well. Its effect on oxygen saturation has not     been studied previously.      The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and     patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV     during port-access in comparison to oxygen saturation throughout OLV during lateral decubitus     thoracotomies.   "
117734|NCT01744873|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fed condition in normal,     healthy, adult human subjects.   "
117737|NCT01744834|"     Overall goal of this study is to scrutinize the relation of learning behavior and related     brain activity to the development of alcohol use disorder (AUD).      The researchers aim is to characterise a representative sample (200 men at age 18) with     regard to learning parameters and their respective neural correlates which are thought to be     indicators for the risk to develop an alcohol use disorder.      As part of a large multi-center study on alcohol dependency (in Dresden & Berlin, Germany)     the researchers will characterize the sample and then prospectively assess alcohol     consumption and development of AUDs over a period of three years.      Among other hypotheses it is expected that increased activation of striatal and prefrontal     brain regions by the Pavlovian-to-instrumental transfer process is related to increased risk     of developing an AUD.   "
117738|NCT01744821|"     The purpose of this research is to study Vitamin D3 replacement for patients at high risk of     developing ovarian, fallopian tube, or peritoneal cancer, and see if the Vitamin D3     replacement may be able to prevent the cancer.      This study is being done because in the United States ovarian cancer is the leading cause of     death among women with gynecologic cancer. Women with BRCA mutations, a personal history of     breast cancer, and a family history of breast and ovarian cancer are at high risk of     developing ovarian, fallopian, and primary peritoneal cancer. Novel treatments other than     surgery which can decrease the risk of developing ovarian, fallopian tube, and primary     peritoneal cancer are important. Vitamin D has been shown to reduce the risk of developing     bladder, breast, colon, endometrial, esophageal, gallbladder, gastric, lung, pancreatic,     prostate, rectal, renal, vulvar and Hodgkin and non-Hodgkin lymphoma, and it may play a role     in the prevention of ovarian cancer.   "
117739|NCT01744808|"     To investigate whether there is a food-effect with oral administration with EB-1020 as well     as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.   "
117740|NCT01744795|"     Minimal invasive monitoring systems of central hemodynamics are gaining increasing     popularity. The present study investigates the precision of the esophageal doppler (CardioQ)     derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC     TD) for measuring CO during steady state and with induced hemodynamic changes in patients     scheduled for elective cardiac surgery.   "
117743|NCT01744756|"     A study to research whether subconjunctival bevacizumab injection may potentially suppress     neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.   "
117746|NCT01744717|"     Pain is an unpleasant and important stress factor, and a potentially harmful experience for     critically ill patients. Pain is harder to evaluate in non-communicative patients, who can´t     report their own pain. Behavioral indicators have been proved as useful and reliable for     detecting and measuring pain in these patients, and have been the basis for constructing     scales for measuring pain, such as the Behavioural Pain Scale (BPS), the Critical Care     Observation Tool (CPOT) and the Scale of Behaviors Indicating Pain (ESCID) .      The BPS and ESCID were tested in a study with a sample of 42 critically ill patients in     Spain, showing good validity and reliability.      The objective of this Spanish multicentre study is to test the validity and reliability of     the ESCID scale in a large sample of critically ill patients with medical and postsurgical     pathology for the detection and measurement of pain.   "
117747|NCT01744704|"     The primary objective of this study is to assess the safety and tolerability of single and     multiple ascending doses of rhNGF when administered as eye drops in healthy subjects.   "
117748|NCT01744691|"     An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase     Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or     Small Lymphocytic Lymphoma with 17p Deletion   "
117749|NCT01744678|"     The purpose of this study is to validate the acceptability, operational feasibility and     efficacy of a combined fatigue countermeasure comprised of shorter-wavelength light and     exercise during operational Orbit 1 night shifts to improve alertness and performance of     flight mission controllers.      Specifically, the investigators will:        1. Feasibility. Test the feasibility of developing a break room containing fatigue          countermeasures (shorter-wavelength light and exercise equipment) to be used by flight          mission controllers during Orbit 1 night shifts, and the feasibility to schedule regular          breaks during the Orbit 1 shift so that flight mission controllers have the opportunity          to use the fatigue countermeasures break room.        2. Acceptability. Test the acceptability of the use of the fatigue countermeasures break          room evaluating when and how the room is used by flight mission controllers, as measured          on End-of-Shift Productivity Questionnaire.        3. Test the hypothesis that alertness and performance will be impaired in flight mission          controllers during Orbit 1 operational night shifts as compared to flight mission          controllers working a non-console day shift.        4. Test the hypothesis that alertness and performance of flight mission controllers who          exercise and are exposed to shorter wavelength light during the Orbit 1 night shift will          be significantly more alert and have better mood, performance (e.g., less PVT lapses,          increased productivity) than those same mission controllers working Orbit 1 night shifts          without exposure to the shorter wavelength light and exercise.        5. Test the acceptability, operational feasibility and efficacy of implementing an          anonymous sleep disorders screening for flight controllers, evaluated by number of          visitors to the screening web site and the number of completed assessments.   "
117750|NCT01744665|"     To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in     patients who achieve MR4.5   "
117751|NCT01744652|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of dasatinib and crizotinib that can be given to patients with advanced cancer.     The safety of this drug combination will also be studied.      Dasatinib is designed to block certain proteins from causing cancer cells to grow out of     control. This may cause the cancer cells to die.      Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause     the cancer cells to die.   "
117752|NCT01744639|"     Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional     assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric     Hepatic Encephalopathy Score and Critical Flicker Frequency.   "
117753|NCT01744626|"     This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine     a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated     Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the     combination of CC-292 and Rituximab in subjects with CLL.   "
117754|NCT01744613|"     Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular     procedures. The clinical significance of an inadequate response to clopidogrel following     percutaneous coronary interventions has been recently recognized.This study was designed to     investigate platelet responsiveness to Clopidogrel following endovascular therapy of     peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine     the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing     outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel     antiplatelet therapy.   "
117755|NCT01744600|"     The study is a cluster randomised control trial, which aims to investigate the effectiveness     of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in     older adults with dementia. In particular, the study aims to identify the main components of     music therapy that are key in achieving this. The study will also explore carers' perceptions     of music therapy, and investigate whether carers become more attentive to patients' needs and     more able to manage patients' BPSD as a result of the music therapy programme.   "
117756|NCT01744587|"     The purpose of this study is to investigate the EBV reactivation rate in post-radiation and     remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the     observational correlation between EBV reactivation and clinical outcome.   "
117757|NCT01744574|"     Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing     impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in     Project I we are proposing a double-blind randomized controlled trial to assess the role of     exogenous progesterone on impulsivity and smoking cessation in a sample of males and females     who are motivated to quit smoking.   "
117758|NCT01744561|"     Physical activity and exercise have become an accepted and valued component of Cystic     Fibrosis care. Regular physical activity and exercise can slow the rate of decline of     pulmonary function, improve physical fitness, and enhance quality of life. However,     motivating people to be more active is challenging. Supervised exercise programs are     expensive and labor intensive, and adherence falls off significantly once supervision ends.     Unsupervised or partially supervised programs are less costly and more flexible, but     compliance can be more problematic. The primary objective of this study is to evaluate the     effects of a 12-months partially supervised exercise intervention along with regular     motivation on forced expiratory volume in 1 second (FEV1) in a large international group of     cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as     well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients     with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited.     Following baseline assessments (2 visits) patients will be randomized into an intervention     and a control group. Thereafter, they will be seen every 3 months for assessments in their     centre for one year (4 follow-up visits). Along with individual counseling to increase     vigorous physical activity by at least 3 hours per week on each clinic visit, the     intervention group will document daily exercise and inactivity time and will receive a step     counter and they will record their progress with a web-based program. They will also receive     monthly phone calls from the study staff. After 6 months, they will continue with the step     counter and web-based program for a further 6 months. The control group will receive access     to this intervention after 12 months of standardized care. Should this relatively simple     program prove successful, this will be made available on a wider scale internationally.   "
117903|NCT01742676|"     The purpose of this study is to evaluate and compare the safety and efficacy of two drugs     (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.   "
117759|NCT01744548|"     This study aims to evaluate the feasibility, acceptability and efficacy of transdiagnostic     Cognitive Behavioural Therapy (tCBT) in comparison to delayed-treatment for depression and     anxiety in older people. CBT is a form of 'talking therapy' that has been recommended by the     National Institute of Clinical Excellence for the treatment of mood disorders. While     traditional disorder-specific CBT has been found to be effective at alleviating individual     mood disorders, it may be less effective when multiple mood disorders are present (i.e. when     there is psychological comorbidity). tCBT is a form of CBT that targets cognitive and     behavioural processes common to a range of mood disorders. Consequently, it may be better     placed to address comorbidity than traditional CBT, both in terms of clinical and     cost-effectiveness.      There is growing evidence that tCBT has beneficial effects on both depression and anxiety in     working-age people. However, the potential benefits of this approach have not yet been     examined in older people (in whom psychological comorbidity is a frequent problem).     Therefore, this study will aim to recruit 22 older people who are experiencing symptoms of     depression and anxiety from community mental health teams within the South London and     Maudsley National Health Service Trust. Participants will be randomly allocated to receive     either tCBT plus treatment-as-usual (TAU) or 7-week delayed tCBT plus TAU. tCBT will be     delivered on an individual basis in 12 sessions, each lasting 1 hour, over 14 weeks. It will     be delivered in outpatient clinics or within the participants residence, depending on     mobility issues. A number of outcome measures will be used to evaluate the feasibility,     acceptability and efficacy of tCBT, including ratings on mood questionnaires, rates of     dropout and reasons for dropout. Outcome measures will be collected before the tCBT     intervention starts (week 0/baseline), midway through the intervention (after the 6th tCBT     session/week 7), at the end of the intervention (after the final tCBT session/week 14) and at     7-week follow-up (week 21) .      The main hypotheses are:      i. It will be feasible to adapt and establish a tCBT intervention for older people with     comorbid depressive and anxiety disorders.      ii. The tCBT intervention will be acceptable to older people with comorbid depressive and     anxiety disorders.      iii. The tCBT intervention will significantly reduce depression and anxiety symptoms relative     to a delayed-treatment control condition.   "
117760|NCT01744535|"     The aim of this study is to implement an exploratory pilot trial of My Meal Mate (MMM), a     smartphone application developed to facilitate weight loss, assessing its feasibility and     acceptability. Overweight and obese adults will be recruited from large employers within the     local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision     based on randomizing 45 people to each arm. Participants will be randomized to one of three     groups. The researchers have developed a smartphone application for weight loss called My     Meal Mate (MMM) which incorporates a large branded food and drink database. MMM was     developed using focus group data collected from potential system users and by benchmarking     with similar commercially available diet tracking applications. One group will receive a     smartphone with the MMM app downloaded on it, one group will receive access to an online food     diary and one group will be given a paper food diary. Participants will be asked to set a     goal for weight loss and self-monitor their food intake and activity using their allocated     study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and     at 6 months. Feasibility and acceptability outcomes will be assessed.   "
117761|NCT01744522|"     The purpose of this study is to investigate, whether leech therapy for the treatment of     postherpetic pain improves pain and sensory function.      Therefore 20 patients with PHN undergoing leech therapy at the investigators outpatient     clinic will be included in this observational trial.   "
117762|NCT01744509|"     In this study the investigators evaluate the sensitivity of PCC2 (PillCam Colon Capsule 2     (R)) in identifying significant polyps in a CRC (Colo Recatal Cancer) screening program     (primary outcome measure).      Each enrolled patient underwent three procedures: colon capsule endoscopy, CT-colonography     and optical colonoscopy. In this study the reference standard is represented by the segmental     unblinded colonoscopy (the unblinding is based on results of both capsule endoscopy and Ct     colonography) The investigators also evaluated the tolerability of PCC2 as compared to     optical colonoscopy (OC) and CT-colonography (CTC).   "
117763|NCT01744496|"     This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain     associated with Parkinson's Disease among patients with advanced stages of the disease.   "
117772|NCT01744379|"     This study will explore the safety, tolerability, and serum uric acid lowering effect of     lesinurad in healthy Japanese males to allow comparison with the Western population.   "
117773|NCT01744366|"     One month degarelix/comparator treatment for prostate cancer in Chinese population   "
117764|NCT01744483|"     Researchers are looking at three different types of breathing tubes to see if any of them are     better at preventing pneumonia than the others. Two of the tubes have design features to     prevent leakage of fluids from the mouth and throat into the lungs. This is importance, since     leakage of small amounts of fluid into the lungs may lead to pneumonia. The third tube is the     standard tube used at most hospitals.      The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs     will reduce the risk of developing pneumonia, compared to the standard tube. The study will     also look at the safety of the modified breathing tubes, compared to the standard tube.      This study is a small, pilot study that will determine if it is possible to perform a     larger study that will provide more certain results.   "
117765|NCT01744470|"     This prospective, interventional, open label, randomized, multicenter study was designed to     determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after     transplantation. Randomized patients are to be stable with their tacrolimus daily dose     required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility     assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of     the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual     dose. The benefit/risk ratio will include the assessment of renal function, histological     lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and     infectious diseases).   "
117766|NCT01744457|"     Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45     and older. Although several clinical tests for the diagnosis and monitoring of DES are     available, currently no gold standard for the assessment of DES exists. It has, however, been     hypothesized that the assessment of tear film osmolarity may be a new and promising approach     of an objective and non-invasive method for diagnosis and monitoring of treatment success.      Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for     the assessment of tear film osmolarity has been introduced. This instrument allows for the     easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about     reproducibility are yet available. Consequently, the current study sets out to investigate     the short time reproducibility of tear film osmolarity measurements using the TearLab®     instrument.   "
117823|NCT01743716|"     This study aims to examine the relationship between mood and brain activity in adolescent     girls in order to better understand the genetic and neural predictors of adolescent     depression. The participants in this study will be healthy female adolescents aged 12-14 and     their mothers. They will participate for a total of six months. Adolescent participants will     have three study sessions at McLean Hospital, and during two of them, their mothers will also     have assessments. Adolescent assessments will include interviews, questionnaires, computer     tasks, and collection of a saliva sample for genetic analyses. Their second study visit will     include an fMRI scan. Parent assessments will include an interview, questionnaires, and a     computer task.   "
117767|NCT01744444|"     Different treatment trials have been published in acquired nystagmus in the last decade;     gabapentin and memantine have been found to be efficient in treating pendular nystagmus in     Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude,     frequency and on visual acuity. None of the trials measured a functional visual score or     oscillopsia score.      The aim of our study is to evaluate the effect of gabapentin and memantine on the mean     velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual     acuity and vision-specific health-related quality of life score, in 10 patients with multiple     sclerosis. The primary object is to find out the best variable to evaluate the efficiency of     nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and     memantine in a common population of patients.   "
117768|NCT01744431|"     Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill     patients      Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation     assays measure the ability of plasma sample to generate thrombin following in vitro     activation of coagulation. In contrast to the classical clotting assays, thrombin generation     reflects and integrates all pro and anticoagulant reactions that regulate the formation and     inhibition of thrombin.      The aim of our study is to investigate whether thrombin generation would be able to predict a     hypercoagulable state in acute ill patients admitted in the internal medical departments and     how it correlates with the Padua prediction score, a score that could assists the risk for     venous thromboembolism in hospitalized medical patients.      In total 300 patients are planned for inclusion in this trial. After signing an informed     consent a blood sample will be obtained from each participant. We will measure the thrombin     generation over time in plasma assessed by the calibrated automated thrombogram (CAT).   "
117769|NCT01744418|"     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the     creation of vascular access for dialysis.   "
117770|NCT01744405|"     The investigators propose to study the transfer of nifurtimox into breastmilk of lactating     women who receive the drug for the treatment of Chagas disease.      Breastmilk and blood samples will be obtained from these patients at pre-specified times     after they take the clinically indicated medication, and the concentrations in both matrices     will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into     breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by     these women to nifurtimox. This study will help clarify safety of continuing breastfeeding     while receiving treatment with nifurtimox for Chagas disease.   "
117771|NCT01744392|"     The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25     individuals among veterans with cardiovascular disease risk factors including Hypertension     (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the hospital-based     primary care clinics associated with Durham VAMC. The investigators will examine veteran's     perception and ease of using an innovative tool to help improve medication adherence to     cardiovascular medications. This study aims to focus on patients with multiple chronic     conditions and their caregivers to address 1) appropriate use of medications 2)maximize     patient self-care and care by families and other caregivers 3) make available a tool for     medication management 4) managing complex regimens, and 5) addressing health literacy.   "
117776|NCT01744327|"     TL1A is a newly discovered signal molecule that may be crucially involved in the maintenance     of chronic inflammatory disorders. TL1A has also been demonstrated in psoriatic skin but the     importance of TL1A in psoriasis is still unknown. Understanding inflammatory signal molecules     in psoriasis is important because the development of new drugs directed against relevant     signal molecules (e.g. TNF-α and IL12/23) has proved to be a very efficacious treatment     principle. However, despite the dramatic progress in therapeutic options during the last     decade, there is still a fraction of patients that are insufficiently treated with the     currently available therapies. TL1A has been claimed to be the next important target for     development of biologics in the field of chronic inflammation.   "
117777|NCT01744314|"     Patients who present to our institution with a traumatic injury to their elbow who need     operative management will be randomized to one of two groups; a treatment arm and a control     arm. The treatment arm will receive a three-week postoperative course of indomethacin while     the control group will not. We will follow both groups to assess whether or not indomethacin     prophylaxis affects the rate of heterotopic ossification.   "
117778|NCT01744301|"     The purpose of this study is        1. to estimate the incidence of seizure in the general population and stratified by          epilepsy status        2. To estimate the relative risk of seizure associated with use of proton pump inhibitors          and histamine 2 receptor antagonist and stratified by epilepsy status   "
117779|NCT01744288|"     Study to see if platelet transfusion stop or lessen the effect of the drug on platelets   "
117780|NCT01744275|"     This a multi-center study to examine whether supplementation with omega 3 fatty acids will     reduce seizure frequency in patients with epilepsy .   "
117848|NCT01743391|"     By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior     to IVF or ICSI (intracytoplasmatic sperm injection      ) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases     pregnancy rates in the intervention group.   "
117781|NCT01744262|"     Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the     past decade and has widely replaced conventional open prostatectomy in many institutions due     to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay.     However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation,     which leads to increased intraocular pressure (IOP). In particular, robot-assisted     laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position     and often prolonged insufflation times, which is known to effect the increase in IOP during     surgery and may result in ophthalmic complications such as postoperative vision loss (POVL).     The majority of patients undergoing RALRP is old aged and often present with comorbidities.     Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient     vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having     undiagnosed glaucoma is also increased, and therefore methods to prevent such complications     are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have     been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous     humour outflow to some extent. Among these agents, propofol has been reported to be more     effective than other inhalational anesthetics in decreasing IOP. The goal of this     prospective, randomized controlled trial is to compare the effect of propofol and sevoflurane     on IOP in patients undergoing RALRP in the steep Trendelenburg position with carbon dioxide     pneumoperitoneum.   "
117782|NCT01744249|"     Assess whether therapy with axitinib, a potent angiogenic inhibitor of the tyrosine kinase     receptors of VEGF bioavailable by oral administration, is capable of improving PFS in     patients with advanced G1-G2 NETs of nonpancreatic origin with progressive disease documented     in the 12 months prior to entering the study.   "
117783|NCT01744236|"     The aim of this study is to detail the (mechanisms underlying the) actions of the GLP-1     receptor agonists and DPP-4 inhibitors on the cardiovascular, renal and gastrointestinal     systems in patients with Type 2 Diabetes Mellitus.   "
117784|NCT01744223|"     This study will evaluate patients with blood cell cancers who are going to have an allogeneic     (donor) blood stem cell transplant from a partially matched relative. The research study will     test whether immune cells, called T cells, which come from the donor relative and are     specially grown in the laboratory and then given back to the patient along with the stem cell     transplant (T cell addback), can help the immune system recover faster after the transplant.     As a safety measure, these T cells have been programmed with a self-destruct switch so     that if, after they have been given to the patient, the T cells start to react against the     tissues (called graft versus host disease, GVHD), the T cells can be destroyed.   "
117785|NCT01744210|"     Historically, transthoracic Doppler echocardiography has been unable to provide interpretable     data of blood flow within the lung parenchyma because of air attenuation of Doppler signals.     Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD)     System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals.     The ability to non-invasively collect information regarding the pulmonary aspect of the     cardio-pulmonary system may provide valuable information and new insights into the structural     and functional characteristics of the lung parenchyma and vasculature in health and disease     states.   "
117786|NCT01744197|"     Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended     to reduce the pain associated with venipuncture and superficial dermatologic procedures by     numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine     patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology     patients undergoing venipuncture as part of their care, for treatment or diagnostics     (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes     that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30     minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS   "
117828|NCT01743651|"     This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled,     parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS     patients with spasticity.      Eligible subjects will be removed from anti-spasticity mediations for at least one week and     then begin study drug treatment with daily doses increasing up to the target dose which will     then be maintained for at least 12 weeks. A down-titration will then occur over two weeks     with the final study visit occuring at 19 weeks from start of achieving the target dose or 22     weeks from the Study Visit 1.   "
117787|NCT01744184|"     This study aims to determine whether Entonox (gas and air) is at least as good as intravenous     midazolam in providing analgesia and sedation during gastroscopy. Entonox is used as an     adjunct in lower gastrointestinal procedures but is not routinely used in gastroscopy, and     there is only one similar published study to date, which was performed in children. The main     advantage of Entonox over midazolam is the quick recovery time following withdrawal of the     agent, which enables patients to return to independent normal life. The investigators would     like to be able to offer Entonox to patients as an option for sedation during gastroscopy,     this study is being conducted to determine if it is a safe and feasible option.   "
117789|NCT01744158|"     Abnormal limb and trunk movements are seen in many children with cerebral palsy. Recognizing     the difference between types of these movements is not well understood. This study aims to     describe how common are these movements in children recruited from a population-based sample     of children identified on a cerebral palsy register, and to explore associations with motor     abilities. It is hoped this will lead to improved understanding and recognition of movement     disorders in CP, to allow clinicians to choose appropriate treatments. We hypothesise that     the underlying prevalence of dyskinesia is higher than that previously identified through     conventional motor descriptions in cerebral palsy populations in Australia, and may approach     20%.   "
117790|NCT01744145|"     The mortality rate and quality of life is effected in patients with pneumonia, especially in     the older population.      The end point of this study is to improve quality of life by and interventional exercise and     education. Patients will be randomized at admission and enrolled into the study. They will be     assessed with various performance and quality of life indicators before, during and after the     study, and exercise tolerance will be assessed throughout and after.   "
117870|NCT01743105|"     The main objective of this study is to evaluate the inter-rater reproducibility of     diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the     first measure) in patients experiencing acute respiratory distress emergencies.   "
117791|NCT01744132|"     The goal of this project is to implement a Collaborative Translational Research Center (TRC)     Network Study which aims to assure optimal two-way communication between ophthalmologists and     their patients' primary care physicians (PCP). The Collaborative TRC Network Study will have     2 objectives:        -  To design and develop common research protocols to develop a 4-year retrospective          database (2007-2010) that compiles electronic billing and medical chart information that          can be used to study individual-level, clinical-level and system-level factors that          impact access to and quality of vision care;        -  To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary          measureable quality indicator, and its relationship to the patients' demographics,          ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other          ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP)          communication.      By enhancing communication and strengthening the clinical information exchanged between PCPs     and eye care professionals, this Collaborative TRC Network study will help to overcome     barriers to obtaining ongoing DFEs and reduce disparities in vision care utilization.   "
117792|NCT01744119|"     The purpose of this observational Post-Market Surveillance Registry is to gather post-market     data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair     of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for     endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60     months post-implantation.   "
117793|NCT01744106|"     This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in     children for the temporary relief of nasal congestion due to the common cold, an indication     described under 21 CFR 341.80(b)(1).   "
117794|NCT01744093|"     In the context of improved survival from HIV infection itself, chronic obstructive pulmonary     disease (COPD); a form of lung disease that includes emphysema, which makes breathing     difficult) is emerging as an important cause of morbidity and perhaps ultimately mortality in     this population. HIV-infected patients are at increased risk of chronic obstructive pulmonary     disease, likely due to multiple factors, including an increased presence of smoking, chronic     inflammation and progression of immunodeficiency, oxidant stress (excessive levels of natural     chemicals called oxidants and free radicals that can damage tissue), and respiratory     infections. While natural history data on COPD are limited in the era of potent     antiretroviral therapy, earlier data suggest that the course of emphysema may be accelerated     in this population. Our preliminary data suggest that several matrix metalloproteinases     (MMPs) derived from alveolar macrophages (a type of immune cell found in the lungs) have an     increased cellular response in HIV-infected smokers, which could contribute to accelerated     emphysema. Matrix metalloproteinases are enzymes that break down the structural support of     tissues, including the airways in the lung.      Based on these observations, the investigators hypothesize that pharmacologic inhibition of     matrix metalloproteinases by doxycycline will favorably modify the natural history of chronic     obstructive pulmonary disease in HIV-infected patients. To test this hypothesis, the     investigators propose conducting a proof of concept pilot study as a prelude to a possible     phase II randomized, placebo-controlled trial (testing safety and efficacy in a larger     population controlled with a sugar pill) of doxycycline for COPD in HIV-infected patients     should the proof of concept be successful. Our research team is lead by a     pulmonologist/researcher with expertise in HIV-associated COPD and an infectious diseases     specialist/clinical trials expert.   "
117795|NCT01744080|"     The purpose of this prospective randomized controlled trial is to compare post-operative     outcome between participants undergoing expedited surgery compared to those proceeding     through a 'typical' wait time process. A secondary purpose is to evaluate the progression of     rotator cuff tear size from the time of initial consult to the time of surgery.   "
117796|NCT01744067|"     Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary     supplements containing omega-3 fatty acids are also commercially available. Some studies have     described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory,     anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and     lipid-modulating effects. Other studies have not confirmed these findings. This study will     investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk     markers in renal transplant recipients.   "
117797|NCT01744054|"     The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a     useful tool in individualizing patient care after the radioembolization procedure. The     information from a PET/MR or PET/CT scan would allow for early evaluation of the technical     success of the procedure.   "
117829|NCT01743638|"     The purpose of this study is to see if MR-guided laser ablation can effectively treat     prostate tumor recurrences.   "
117830|NCT01743625|"     The purpose of this study is to show the effectiveness of COV155 compared to placebo in     subjects with acute moderate to severe pain following bunionectomy surgery.   "
117798|NCT01744041|"     Perinatal depression is a major public health problem, affecting 15% of women during     pregnancy through the postpartum period, with adverse consequences for the mother, the fetus,     the infant, and the family. Despite increasing evidence of the importance of this critical     risk interval, little research has investigated the effects of depression treatment during     pregnancy on infant outcomes. The purpose of this study is to test the feasibility,     acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the     mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with     the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad     will be better than treatment as usual in reducing depressive symptoms, improving     psychosocial functioning,increasing parenting self-efficacy, improving infant emotional     development, and enhancing mother-infant relationship quality.   "
117799|NCT01744028|"     The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system using     a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in preventing     hospitalization from Chronic Obstructive Pulmonary Disease (COPD) exacerbations in a COPD     population at high risk of exacerbation, compared to those managed by usual care.   "
117800|NCT01744015|"     1. (Primary) To compare the effectiveness of a patient guided choice of care using a          patient decision support tool to clinical guided care within a novel care process for          non-specific low back pain.           (We hypothesize that the patient guided choice model will demonstrate significant          improvements when compared to the clinician guided care approach)        2. (Secondary) To qualitatively investigate which components of the patient choice          educational methods were most effective for informed decision making among patients who          participate in the patient guided choice of care approach (We hypothesize that dialogue          method of patient guided choice will be identified as most useful)   "
117801|NCT01744002|"     The objective of this study is to investigate whether treatment directed at the neck and     shoulder is more beneficial than treatment directed solely at the shoulder; for patients with     shoulder impingement syndrome.      (The hypothesis is that patients who receive neck mobilization will improve at a more     significant rate than those who do not receive neck mobilization)   "
117802|NCT01743989|"     This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation     treatment, in order that patients remain in treatment-free remission (≥MR4.0) 12 months after     starting the Treatment-Free Remission (TFR) phase of the study.      Rationale:      CP-CML patients who have received 2 or more calendar years of first-line imatinib treatment,     and who have failed to achieve the molecular response threshold for treatment cessation     (≥MR4.0) have a 50% greater chance of doing by switching to nilotinib; however the optimal     duration of consolidation treatment with nilotinib to ensure the highest rate of patients     remaining in ≥MR4.0 after entering the TFR phase is not yet known. This protocol therefore     aims to assess the potential impact of a longer duration of consolidation treatment with     nilotinib, i.e. 12 months versus 24 months, on molecular relapse rate in the first 12 months     of treatment-free remission.   "
117803|NCT01743976|"     Based on laboratory studies, donepezil will improve pain relief more than placebo in patients     with chronic neuropathic pain who are currently taking gabapentin or pregabalin.   "
117804|NCT01743963|"     Using glucocorticoid induced diabetes (GID) we will conduct a small feasibility randomized     intervention trial to improve GID management for veterans who are prescribed chronic     glucocorticoids. Approximately 20 primary care providers (caring for approximately 100     veterans on chronic steroids) will receive decisional support (automatically-derived orders     for hemoglobin A1C, to be co-signed by providers). Approximately 20 providers (caring for 100     veterans) who did not receive decisional support will serve as the control population. We     will measure the time from randomization until the provider signs an order for hemoglobin A1C     for both groups. The trial will be conducted at the VA's Eastern Colorado Health Care System     (ECHCS) and will last approximately 6 months. After the completion of the trial for each     provider, we will conduct a brief interview and survey of the participating providers to     assess the acceptability of decisional support interventions to manage GID [protocol, page     1-2]. No patient data (PHI) will be collected by the providers.   "
117805|NCT01743950|"     To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27     fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until     time of progression in patients with recurrent high grade gliomas (grade III and grade IV).     Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior     exposure to bevacizumab.   "
117806|NCT01743937|"     Antiplatelet therapy remains a cornerstone in the treatment of acute and chronic coronary     artery disease. Aspirin was the first such therapy to prove its benefits in acute myocardial     infarction. Compared to aspirin monotherapy, the combination of aspirin and clopidogrel, a     thienopyridine P2Y12 inhibitor, has been demonstrated to reduce adverse event rates among     patients with acute coronary syndromes (with or without ST-segment elevation) and those     receiving intracoronary stents. In the Triton-TIMI 38 trial a novel thienopyridine,     prasugrel, was compared to clopidogrel in patients with acute coronary syndrome undergoing     percutaneous coronary intervention. Although prasugrel significantly reduced recurrent     myocardial infarction, bleeding rates were increased and no improvement in cardiac or     all-cause mortality was demonstrated. However, in 2009, the authors of the PLATO trial     demonstrated an unexpected cardiovascular mortality benefit with ticagrelor over clopidogrel,     an endpoint not previously met by any other antiplatelet agent against an active comparator.     Based on the reproducible adverse events seen in the DISPERSE, DISPERSE-2, and PLATO trials,     an adenosine-mediated effect of ticagrelor is proposed.      Hypothesis: The aim of this study is to test the hypothesis that ticagrelor produces     pharmacologic ischemic preconditioning, an undescribed potential off-label property of     ticagrelor that could represent a plausible mechanism for its effects on cardiovascular     mortality.   "
117807|NCT01743924|"     The aim of this study was to determine the absorption of isothiocyanates (ITC) after     ingestion of kailan-hybrid broccoli through the analysis of the correspondent urinary     biomarkers. Furthermore, the effect of cooking (microwave) on the mentioned metabolic fate of     these ITC was studied comparing to the uncooked vegetable.   "
117831|NCT01743612|"     The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of     the hand with Laser speckle contrast imaging discriminate between patients with systemic     sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.   "
117808|NCT01743911|"     Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In     addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has     been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic     function in hypertensive rats, despite any difference in blood pressure levels. Also, left     ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients.     However, it is unknown if these effects exists in humans with resistant hypertension.     Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil)     for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.   "
117809|NCT01743898|"     The ability to explain bleeding or clotting complications in patients treated with     rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests     perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of     coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding     abnormal responses to rivaroxaban. The purpose of the study is to define a therapeutic     reference range for peak and trough coagulation tests in patients taking FDA approved doses     of rivaroxaban and to determine which tests may be most clinically useful for monitoring     rivaroxaban.   "
117810|NCT01743885|"     There is no effective treatment for hemangioma regardless of immediate severity. That is in     this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of     proliferation of several months (very scary for parents) and regression over several years.     The natural history is peppered with local complications (ulcers) and aesthetic and     psychological sequelae (sometimes major for the child and the family). The effects of     acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by     two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and     propranolol have been used for many years for the treatment of hypertension and congenital     heart disease, including infants, with few side effects. The effects of acebutolol and     propranolol were immediately visible with reduced volume and skin whitening of the     hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier     with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy     of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of     infantile hemangioma in infants.   "
117811|NCT01743872|"     Iodinated contrast is the current gold standard for infrainguinal angiography imaging in     patients without renal insufficiency and has also been used with intravascular Optical     Coherence Tomography (iOCT) to improve image quality in human coronary arteries as well as     carotid arteries. The current debate in the literature for iOCT medium is between iodinated     contrast and dextran and CO2 may offer a superior method of iOCT imaging during lower     extremity occlusive disease interventions.      The investigators hypothesize that the CO2 medium injection during iOCT data acquisition is     feasible and will produce at least the same quality of imaging as that obtained with contrast     or dextran without causing the problems of volume overload and renal toxicity seen with the     two latter mediums.      Primary Outcomes Measured        -  Quality: Cumulative number of clear image frame (CIF) through the entire 54mm length          segment.        -  Quantitative: Calculations of the area and diameter of each segment will be measured to          determine if index of refraction has any effect between the three mediums to be tested.      The investigators expect to find little difference between all three iOCT mediums and hope to     conclude that CO2 offers a superior side effect profile for iOCT imaging in the lower     extremity arterial system.   "
117812|NCT01743859|"     The primary objective of this study is to determine the complete remission/complete remission     with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute     myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.   "
117813|NCT01743846|"     Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic     variables achieved by a PICCO monitor.      Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the     accuracy of CNAP.   "
117814|NCT01743833|"     Shoulder impingement has been identified as the most common cause of shoulder pain in the     adult general population. Sometimes therapeutic pushing on the middle part of the back     (manual therapy) decreases shoulder pain in someone experiencing shoulder impingement. We do     not known what causes the decreased shoulder pain. It could be that the therapeutic pushing     makes things move better. It may be that the person getting their back treatment thinks they     are better or the physical therapist who provides the manual treatment thinks it works.   "
117815|NCT01743820|"     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low     single-dose primaquine for gametocidal activity against P.falciparum among adult     glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.   "
117816|NCT01743807|"     This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed     and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who     are in morphologic remission but are positive for Minimum Residual Disease (MRD). GNKG168 is     a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an     effective anti-tumor immune response as they are able to stimulate both innate and adaptive     immune responses. There will be two strata i.e patients who have received hematopoietic stem     cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be     administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed     by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to     determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients.   "
117832|NCT01743599|"     Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction     is registered with a validated questionaire (International Index of Erectile Function-15).     Concentration, total number of sperm and motility is determined in freshly delivered     ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly     higher rate of retrograde ejaculation than healthy controls.   "
117833|NCT01743586|"     The purpose for the 1st phase of this study are to exam longitudinal changes and the impact     of various treatments on the respiratory muscle function, and the relations with dyspnea,     functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival     status (control group). The 2nd phase of this study will investigate the potential beneficial     effects of chest physiotherapy in the same patient population (intervention group).   "
117817|NCT01743794|"     Introduction : Spine surgery is responsible for intense postoperative pain that can be     treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia).     Continuous wound infiltration is an efficient and simple technique with few adverse effects     yet very few studies have investigated its potential use in spine surgery. Our randomised,     controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration     after major spine surgery.      Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a     multiholes catheter under muscular layers. Patients are randomised in two groups : The     treated group receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by     8 mL/h continuous infusion during 48 hours) and the control group receives saline solution     (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia.     The investigators hypothesize that the treated group will consume morphine less than the     control group.   "
117818|NCT01743781|"     1. To evaluate a educational intervention promoting acceptance of comprehensive eye          examination in rural Guangdong.        2. To evaluate the impact of acceptance of comprehensive eye examination in rural          Guangdong.   "
117819|NCT01743768|"     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of     the immune system caused by cytokine production. A substantial number of asthma patients do     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for     novel targeted therapies with improved specificity, tolerability, and compliance.      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting     early disease-causing mechanisms are a promising approach for the treatment of asthma. The     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and     has been shown to be necessary and sufficient for the production of cytokines interleukin     (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product     SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the     10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).      DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic     acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and     thereby reduces key features of allergic airway inflammation. DNAzymes are generated     completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP)     controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by     use of any living organism including cell culture or bacteria. The molecules are highly     water-soluble and will be applied as solution directly in their synthesized form.      This proof-of-concept study will evaluate the safety, tolerability, efficacy,     pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of inhaled SB010 in male     patients with mild asthma.   "
117820|NCT01743755|"     The present study is designed to investigate the beneficial effects of adjunctive     dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally     aiming at assessing what patients benefit from dexamethasone treatment mostly. A large     multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with     placebo in 600 patients and with predefined subgroup analyses planned.   "
117821|NCT01743742|"     To study the role of single high dose vitamin E and vitamin C in hypoxic ischemic     encephalopathy in newborns, in reduction of morbidity and adverse neurodevelopmental     sequelae.   "
117822|NCT01743729|"     The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic     solution compared to placebo in the treatment of dry eye.   "
117824|NCT01743703|"     The diagnosis of abuse in children relies heavily on the presence of skeletal and     extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And     the investigators have to complete the skeletal survey with either bone-scan or CT scan or     whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the     evaluation of skeletal and extraskeletal lesions in children with cancer or infectious     diseases. Thus, whole-body MRI would allowed to have total picture of children without     ionising radiation exposure.   "
117825|NCT01743690|"     The aim is to investigate the effect of probiotic bacteria on symptoms and clinical     manifestations in patients with oral lichen planus (OLP).      The hypothesis is that probiotic bacteria can favor an oral environment that reduces the risk     of symptomatic candidal and bacterial infection in OLP.      The negative influence of improper oral hygiene on OLP is established and overgrowth of     Candida is a common problem. Nystatin is the only topical antifungal that does not interact     with other drugs and to which the majority of the candida species are susceptible.     Symptomatic treatment with fluocinolone is initiated in patients without candidal infection.     Probiotic bacteria can affect the microbial homeostasis by reducing the overgrowth of     pathogens e.g. candida. Different probiotic species have been shown to produce antifungal     substances and reduce the growth of candida albicans in vitro. The probiotic strain     Lactobacillus rhamnosus has been found to reduce the salivary count of yeasts among elderly     in a randomized clinical study.      The study is planned as a blinded, randomized controlled study with four parallel arms. 120     OLP patients with symptoms form the mucous membranes are included in the study and will     receive nystatin or fluocinolone treatment depending on positive or negative diagnosis of     candidosis. In addition, they will be assigned to either the probiotic (A) or the placebo     group (B) by randomization. The groups will be encouraged to take three tablets per day     (morning, noon and evening)for eight weeks. The lozenges containseither two strains of the     probiotic bacterium L. reuteri (A) or placebo (B). Cytosmears, saliva sample, and saline     mouth wash will be taken at baseline, after the treatment period and at follow-up visits at     8, 16, 24 weeks and 1 year. Salivary counts of the probiotic strains, the clinical     manifestations and symptoms associated to OLP will be recorded.   "
117826|NCT01743677|"     ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine     whether intensive monitoring of QT interval in target patient populations is required during     later stages of development. The current study is designed to ascertain whether CP-690,550 is     associated with QTc prolongation.   "
117827|NCT01743664|"     Multiple Sclerosis (MS) can be associated to many psychological symptoms. One of the most     relevant is the experience of distress related to the disease, that can lead to the     development of Post Traumatic Stress Disorder (PTSD). As far as we know there are no studies     on the efficacy of psychological treatments in MS in spite of its relevance for patients'     quality of life. Primary aim is to evaluate the efficacy of the treatment with Eyes Movement     Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective     treatment (together with Cognitive Behavioural Therapy) for PTSD according to international     guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated     symptoms of anxiety and depression and Quality of Life. The study design is a randomized     clinical trial. Sixty patients with MS and PTSD will be pre-screened by using the IES-R and     the Clinician Administered PTSD Scale. The patients will be randomized in two groups (30 in     the experimental group and 30 in the control group).The psychological assessment will be     performed in both groups with the same timing and tools: at baseline (T0), after treatment     (T1) and 6 months later (T2) by two trained clinical psychologists (independent and blind to     treatment) with the CAPS and the administration of self reports: Trauma Antecedent     Questionnaire, Chicago Multiscale Depression Inventory, Hospital Anxiety and Depression Scale     and Functional Assessment of Multiple Sclerosis. The experimental group will undergo 10     weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic     events. The efficacy will be evaluated comparing the results between T0, T1 and T2 and     comparing the scores of the experimental and the control groups. Primary outcome measures     will be: 1) the proportion of participants at T1 and T2 no longer meeting the Diagnostic and     Statistical Manual (DSM IV-TR) diagnostic criteria for PTSD; 2) the reduction of CAPS scores     for the four PTSD dimensions from pre-treatment to post-treatment evaluation and follow-up     (avoidance, reexperiencing the traumatic event, hyperarousal and numbing). Secondary outcome     measures will be: comparison of the scores of CMDI, HADS and FAMS of the two groups at T0, T1     and T2. The statistical procedure applied will be a repeated measures analysis of covariance     both on the primary outcome continuous measures and on the secondary ones.   "
117834|NCT01743573|"     This study wants to prove that Yoga Training can improve physical Fitness, immunity, and     quality of Life of in Breast Cancer Survivors. In summary, our findings show potential     benefits of yoga for people with cancer in improvements of psychological health. Because of     the small number of studies having been conducted and the methodological limitations, the     results should be regarded as preliminary and treated with caution. Our preliminary findings     also provide practitioners with important information that yoga may be a possible adjunctive     therapy for cancer patients to help manage psychological distress and to improve quality of     life.   "
117835|NCT01743560|"     Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily p.o.)     and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen receptor     positive breast cancer who have previous experienced recurrence or progression on     non-steroidal aromatase inhibitor (NSAI) therapy.   "
117836|NCT01743547|"     This is a pilot study to establish the feasibility of an eight-week yoga intervention and to     estimate the effect size on QoL in female patients with ovarian, fallopian tube and primary     peritoneal malignancies receiving chemotherapy for the treatment of primary or recurrent     cancer.   "
117837|NCT01743534|"     The insanities, priority of public health in 2008, have significant prevalency in Limousin,     region in the ageing demography (1/3 of the population is more than 60 years old against     1/5th of average in France). To prevent the lack of therapeutic solutions, for these     evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.      The insanities deprive gradually the individual of their autonomy, their personality and     their identity. The help of an institution is sometimes inevitable. In the middle of this     stressful environment, the patient affected by severe insanity, need marks.      The aspect of their old objects, significant for them, has to be prioritized because the     institutional universe, often depersonalized doesn't mean anything for them. In front of     repeated failures, they're hurt in their self respect.      The prevention of the undernutrition, comes by a preservation of praxis and pleasure at     table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular,     divided) and can be destabilizing for the mentally ill person.   "
117838|NCT01743521|"     To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin,     Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.   "
117839|NCT01743508|"     Uganda is one of the countries with highest fertility rate in the world, 6.7 children per     women. It is estimated that 56 percent of all pregnancies are unintended and the     contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and     induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and     mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units     in Uganda due to unsafe abortion is reported and considered high in international comparison.     Studies have revealed that trained midlevel providers can deliver safe post abortion care for     incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue     misoprostol has been shown to be an effective tool in the treatment of incomplete abortions.     This option is so far under-used in developing countries, especially outside the larger     hospitals and private clinics. One significant limiting factor in providing safe post     abortion care is the lack of providers. So far technical training has been mainly limited to     physicians. Training of midlevel providers in misoprostol treatment of incomplete abortion     will support task shifting in places where doctors are costly and scarce. By evaluating the     effectiveness of mid-level providers (midwives); conducting MVA and administering misoprostol     treatment of incomplete abortion the project is attempting to contribute to the reduction of     maternal mortality and morbidity and safeguard high quality of post-abortion care.      Women with incomplete abortion will be randomly allocated to undergo a clinical assessment     and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy as     main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that     there are no significant differences in effectiveness and safety between manual vacuum     aspiration and misoprostol treatment of incomplete abortion provided by physicians and     midwife.      The involvement of midlevel providers in treatment of incomplete abortion has previously not     been systematically evaluated in African health care setting.   "
117840|NCT01743495|"     The Johns Hopkins School of Nursing offers this research study which aims to learn more about     whether services that help with medications, muscle strengthening, pain management and     changes to houses can help improve older adults' ability to, walk, and take care of     themselves while saving costs by reducing hospitalizations and nursing home admissions.   "
117841|NCT01743482|"     This is an open label, single arm, single center, phase 2 study with the use of the     antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell     tumors who are not cured following first or subsequent chemotherapy lines for metastatic     disease, followed by eventual surgery.   "
117842|NCT01743469|"     This is an exploratory proof of concept study to determine the clinical activity of     tasquinimod in patients with advanced or metastatic hepatocellular carcinoma (Cohort H),     ovarian carcinoma (Cohort O), renal cell carcinoma (Cohort R) and gastric carcinoma (Cohort     G) who have progressed after standard therapies.   "
117843|NCT01743456|"     Post-Operative Cognitive Decline (POCD) is common after cardiac surgery and associated with     increased morbidity and mortality. The pathophysiology of POCD is only poorly understood.     Causes include hypoperfusion, microemboli and the systemic inflammatory response, which     result in a reduction of cerebral oxygen delivery.      Cerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen     saturation (rSO2).      The bispectral index (BIS) of the electroencephalogram is widely known to measure depth of     anaesthesia, and there is a high correlation between BIS, a dimensionless calculated number     between 0 and 100, and clinical criteria of sedation. With BIS below 60 recall is extremely     low.      The investigators demonstrated recently that inappropriately high levels of anaesthesia may     be associated with poorer long-term outcomes in cognition after non-cardiac surgery (Ballard     et al. 2012). Whether optimisation of the depth of anaesthesia and cerebral oxygenation has     an effect on postoperative cognitive function in patients undergoing cardiac surgery is     unknown.      The investigators hypothesize that the incidence of POCD in elderly patients (> 65 years old)     at 6 weeks is less with mildly deep anaesthesia (BIS 50 +- 10) and optimised rSO2     (interventions when rSO2 drops below 15% of baseline reading) when compared with current     practice (BIS blinded anaesthesia, reflecting moderately to highly deep anaesthesia and     blinded rSO2 measurements).   "
117844|NCT01743443|"     To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients     with progressive lower stage keratoconus.   "
117858|NCT01743261|"     The aim of this study was to compare the cost/utility ratio of a management model of     integrated, graded, intensive rehabilitation (GIR) versus usual care (UC) for patients with     acquired Severe Brain Injury (SBI).   "
117940|NCT01742195|"     The aim of this study is to determine if the insertion of the linear endobronchial ultrasound     bronchoscope is more comfortable for patients when done through the nose compared to its     insertion through the mouth. Our hypothesis is that nasal insertion is more comfortable.   "
117845|NCT01743430|"     Study 1: Background and Purpose—This study were to set up the telerehabilitation program for     standing balance training, and to examine the training effects on balance and daily     activities in subjects with subacute stroke.The null hypothesis included telerehabilitation     balance training were not significantly different from conventional balance training in     subjects with subacute stroke.      Study 2: The purpose of this study was to investigate the effects of telerehabilitation with     group therapy on balance and daily activities in subjects with stroke living in long-term     care facilities (LTC).The null hypothesis would be telerehabilitation balance training were     not significantly different from conventional balance training in subjects with subacute     stroke.      study 3:To investigate whether a four-week tele-rehabilitation program can result in     significant improvements in physical function and quality of life for subjects with chronic     stroke living in long-term care facilities.      Study 4: To compare the effects of a home-based telerehabilitation (Tele) with intelligent     agent systems and a conventional in-home physical therapy (home PT) for subjects with stroke.   "
117846|NCT01743417|"     Brain training exercises will be provided to children who survived an episode of severe     malaria. These children will be given assessments for cognition, behaviour and executive     functions before and after the brain training exercises.   "
117847|NCT01743404|"     The purpose of this study is to investigate the anti-atherosclerotic effect of long-term     anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical     atherosclerosis of carotid arteries.   "
132486|NCT01550835|"     The purpose of this study is to determine whether aspiration thrombectomy following carotid     stent deployment will reduce the number of procedure related signals as identified by     diffusion weighted MRI of the brain.   "
117849|NCT01743378|"     A Prospective double-blinded randomized clinical trial to test the effect of transversus     abdominis plane block on postoperative pain and opoid consumption after abdominal     hysterectomy.      Two groups of each 24 patients. All patients are given general anesthesia. The patients are     randomized to have a ultrasound guided bilateral transversus abdominis plane block with     either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided     with a PCA for self administration of morphine.      Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24     hours postoperatively as well as the total consumption of morphine after 24 hours.   "
117850|NCT01743365|"     The purpose of this study is to evaluate the efficacy and safety of the combination of     Cisplatin,5-Fluorouracil(5FU) and Afatinib as first-line therapy in patients with advanced     gastric or gastroesophageal junction cancer. The study will include 55 patients in all. The     patients will receive open-label Cisplatin intravenous 75mg/m2 on Day 1, 5FU 750mg/m2 at     24-hour intravenous infusion on Days 1-4, and Afatinib 40mg per os on Days 3-5, 8-12, 15-19.      The administration of Afatinib will start on Day 3 of each therapy cycle with an     administration interval on each weekend (Weekday on, Weekend off) for 21 days. Instructions     are given on the dose reduction scheme in the presence of toxicity. The administration of the     combination Cisplatin-5FU-Afatinib will be continued until disease progression, appearance of     significant toxicity, completion of 6 treatment cycles, or withdrawal of consent. At     completion of 6 cycles of the combination, in the absence of disease progression, the     administration of Afatinib as maintenance monotherapy will be continued until disease     progression, appearance of significant toxicity, or withdrawal of consent at the weekday     on-weekend off schedule. Imaging will be applied once every 8 weeks, and once every 12 weeks     in the Afatinib maintenance therapy phase.   "
117851|NCT01743352|"     The aim is to compare a new technique for assessing mechanical properties of large arteries:     the Ultrafast echo with the reference technique, the echotracking. This will be done by     studying in parallel hypertensive patients and controls with both techniques and this will     revisit old concepts of increased stiffness in hypertensive arteries.   "
117852|NCT01743339|"     The primary purpose of this study is to test whether and how cognitive-behavioral therapy for     insomnia (CBTi), a well-supported and highly effective insomnia treatment, may directly     improve Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) symptoms.     The study is designed as a randomized controlled trial (RCT) to test the effect of CBTi on     symptoms of PTSD and co-morbid depression prior to an evidence-based PTSD intervention and to     assess the role of neurobiological processes and sleep architecture in mediating treatment     outcomes.   "
117853|NCT01743326|"     Rationale: the facet joints are an important pain generator in chronic neck pain. The     beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been     described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated     Disorders. In patients with degenerative neck complaints a positive effect has been described     in observational studies. Given this positive effect performing a RCT of RFD in this patient     population is indicated.      Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic     degenerative neck pain.      Study design: prospective, randomized, double blinded clinical trial. Study population:     patients older than 25 years, referred to the University Pain Center of Maastricht and the     Pain Center of Amphia hospital Breda, with chronic axial neck pain.      Intervention: patients with at least 3 months of neck pain without radiation to the arm (only     radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD + local     anesthesia-group=intervention group) will receive RF treatment adjacent to the medial branch     innervating the cervical facet joints after the application of bupivacaine 0.5 ml (0.25%).     The second group (local anesthesia-group=control group) will only receive the application of     0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference between the two     groups is the RF-denervation of the medial branches.      Main study parameters/endpoints: the primary research question is to evaluate the extent of     pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group)     compared with the local anesthesia-group(control group.      Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression     of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient     Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression     scale (HADS), and Neck Disability Index (NDI, Dutch version).      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Patients in the RFD + Local Anesthesia-group and Local Anesthesia-group will     undergo a physical examination before and 6 weeks after the intervention, by an independent     third party, this will be repeated at 3 and 6 months if abnormalities are observed. At each     of these time points the patients will receive questionnaires to fill out. A puncture of a     blood vessel is possible, diagnosed by injection of contrast, for which repositioning of the     needle is needed. Should accidental intravascular injection of local anesthetic occur, the     dose used is low and reports show that intravascular injection of bupivacaine 2,5 mg does not     pose clinical problems. The dura can be punctured; as a consequence contrast will flow in the     cerebrospinal fluid. The procedure will be stopped and repeated after a few days. In theory a     lesion of the nerve root is possible, but the needles are designed to avoid this, this     complication has not been seen since more than 10 years. Up till now, a transient pain is     occasionally described after the RF treatment. No hypesthesia or motor complications were     reported. Since the risks of RF treatment are reported low and more related to needle     placement there is no difference in risk and burden between the two treatment groups.   "
117854|NCT01743313|"     Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and     changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol     levels) are examined. Persistent postoperative pain is examined as secondary outcome.   "
117855|NCT01743300|"     In this prospective pharmacokinetic we investigate the following topics:        -  The influence of grapefruit juice and orange juice on the steady-state pharmacokinetics          of sunitinib in cancer patients        -  The influence of sunitinib on the pharmacokinetics of midazolam in cancer patients        -  The relationship between Cytochrome-P450-3A4 (CYP3A4) phenotype, as assessed using the          midazolam clearance test, and the steady-state pharmacokinetics of sunitinib in cancer          patients        -  The effect of grapefruit juice and orange juice on CYP3A4 metabolism   "
117856|NCT01743287|"     The purpose of this study is to evaluate efficacy and safety of Imotun capsule in     osteoarthritis of the knee   "
117857|NCT01743274|"     Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional     images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT     uses a near-infra-red light source to obtain images of the interior walls of the coronary     arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess     placement and response to stenting. - To date, no study has evaluated whether optical     coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI)     and stenting.      The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided     angioplasty would provide useful clinical information beyond that obtained by angiography,     and whether this information would subsequently modify physician behavior and treatment     choices. In particular, we will evaluate the impact of changes in procedural strategy     resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after     angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute     coronary syndromes.   "
117859|NCT01743248|"     The surgery of a vestibular schwannoma induces balance disorders which have a an impact on     the patient's daily life and disrupt their quality of life.      But the balance disorders don't seem to be the only ones factors that impaired the patient's     quality of life. It has been alrealdy shown that emotional and psychological factors are also     related to patient's quality of life.      This study evaluates the relationship between the balance control compensation and these     factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.   "
117871|NCT01743092|"     Research specific to women's gambling treatment needs is limited but suggests a critical need     for women sensitive options and reduced barriers to access. This pilot will test the     effectiveness of a Tutorial Workbook (TW) both as a self-help tool and used in combination     with a webinar. Ontario women(n=48) over the age of 19, with gambling concerns, will be     recruited through flyers, on-line and newspaper ads and randomly assigned to one of two     groups: (a) TW or (b) TWW (TW plus Webinar). All will complete questionnaires addressing     gambling behaviours, personal history and mood states prior to and after the 12 week study.     Groups (a) and (b) will also provide feedback on the TW's content and relevance. Group (b)     will, in addition, provide feedback on the Webinar Group. TW and TWW will be valuable     additions to current treatments, of special importance to reduce barriers for women. The     study will contribute to best practices in developing web-based treatments.   "
117872|NCT01743079|"     The purpose of this study is to evaluate the efficacy and safety of telbivudine and     lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in     highly viraemic mothers.   "
117860|NCT01743235|"     A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety     and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive     sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in     healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s).     Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours     after each sexual activity. The following hypotheses will be tested:      Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual     events.      The number of satisfying sexual events will not differ significantly between subjects treated     with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone     alone.      Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.      Sexual desire/arousal will not differ significantly between subjects treated with placebo and     subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.      Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase     the number of satisfying sexual events and sexual desire/arousal.   "
117861|NCT01743222|"     The objective is to determine the safety, tolerability and feasibility of the inguinal     intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)   "
117862|NCT01743209|"     The main objective of the study is to describe the french population of individuals with     paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed.     The secondary objectives are the description of social demographic profiles, the personal and     family histories,psychiatric co-morbidities, the side effects of androgen antagonists     treatment. This study, the first of its kind in France, may allow to better understand the     social demographic and clinical profile of sexual offenders with paraphilias treated with     androgen antagonists.      To be included, the subject must have committed a sexual offense and must present a diagnosis     of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is     defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized     by sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally     involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner,     (3) children or other persons without their consent, occurring during a period of at least     six months (Criterion A). This disorder is responsible for sexual behavior which is     clinically significant disturbances in social, occupational or other important areas of     functioning (Criterion B).      The inclusion of approximately 200 subjects is expected in this study. The inclusion period     will last for 12 months.      Data will be codified and only a few investigators will have access to these data. The     statistical analyse will use the usual descriptive parameters: mean, standard deviation,     median, interquartile range and range for quantitative variables, frequencies and cumulative     frequencies (if applicable) for qualitative variables.   "
117863|NCT01743196|"     The purpose of this study is to determine if there is a difference in the short term response     in serum folate after a single dose of folic acid in normal weight and obese women of     childbearing age.   "
117864|NCT01743183|"     This study aims to evaluate pulmonary function and respiratory muscle strength in a group of     elderly women with hypertension before and after a respiratory muscle training.   "
117865|NCT01743170|"     The proportion of hypertensive patients achieving adequate blood pressure control meeting     guideline targets remains low. Of hypertensive patients, only 50% are on antihypertensive     medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure     controlled.      The objectives of this study are:        1. To test the feasibility of telemonitoring of blood pressure in Flemish general          practices.        2. To investigate in a randomized fashion whether telemonitoring enabled self-measurement          of blood pressure leads to faster blood pressure control than self-measurement without          the telemonitoring information.        3. The secondary endpoints include various blood pressure indexes, adverse effects, a          simple assessment of quality of life, adherence, a log of technical problems, and cost          effectiveness (EQ-5D-5L).   "
117866|NCT01743157|"     A phase I-II study of treatment of metastatic melanoma using induction therapy with     Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).   "
117895|NCT01742780|"     The purpose of this study is to determine if there is one method of identifying the proximal     humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4     methods being evaluated.   "
117979|NCT01741688|"     This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in     routine clinical practice in participants with moderate to severe rheumatoid arthritis.     Eligible participants initiated on tocilizumab treatment in accordance with the local label     were followed for 6 months.   "
117867|NCT01743144|"     Rationale:      Pediatric Adenotonsillectomy is a common procedure of brief performed on a day-case basis, in     which rapid recovery with safe airway after extubation is crucial. Sevoflurane is considered     the inhaled anesthetic of choice in such procedures, however it has been reported that     emergence agitation (EA) is a frequent complication in 30-80% of children receiving     sevoflurane general anesthesia. The possible effect of magnesium sulphate on decreasing the     incidence of EA in children was not adequately investigated.      Objective:      To assess the possible effects of intraoperative intravenous magnesium sulphate (MgSO4)     infusion on the incidence of sevoflurane-induced EA in children undergoing     adenotonsillectomy.      Study population and sample size:      Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy under     sevoflurane general anesthesia. 64 patients (32/group) is required to detect a significance     difference of 40% in the incidence of agitation between two groups, with a power of 80% and     alpha error of 5%.      Study design:      A double blind, randomized, placebo controlled study.      Method:      In the placebo group, a normal saline bolus dose 0.3ml/kg will be iv infused followed by a     continuous infusion of 0.1 ml/kg/h. In the MgSO4 group, a MgSO4 bolus dose 0.3mL/kg will be     iv infused followed by a continuous infusion of 0.1 ml/kg/h. infusion terminated by the end     of surgery. Post operative emergence agitation will be assessed by using the Pediatric     Anesthesia Emergence Delirium scale.      Possible risks:      Drug side effects such as facial warmth, flushing, dry mouth, and malaise.      Outcome parameters:      The primary outcome: incidence of sevoflurane-induced EA measured using the Pediatric     Anesthesia Emergence Delirium (PEAD). Secondary outcome: postoperative pain and rescue     analgesic requirements, perioperative hemodynamics, durations of recovery, postoperative     complications      Statistical analysis plan:      Student's t-test or Mann Whitney-U and Chi square or Fisher's exact tests will be used as     appropriate. The possible relationship between EA and pain scores will be evaluated with the     use of Spearman's rank correlation coefficient      Time plan:      6-9 months.   "
117868|NCT01743131|"     This is a phase II multi-center, randomized, double blind, placebo-controlled trial.      The investigators are doing this study to see if a new drug, abatacept, can be used together     with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better     protection against Acute Graft versus Host Disease (aGvHD) without causing more infections.      Funding Source - FDA OOPD   "
117869|NCT01743118|"     The current most important topical treatments for psoriasis are vitamin D3 analogues and/or     corticosteroids. The possibility of another effective treatment for psoriasis could be based     on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.      The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic     efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical     Vitamin-D analogue ointment in a psoriasis plaque test.   "
117873|NCT01743066|"     To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know     the levels of vitamin E in patients chronically exposed to high concentration of arsenic and     if changes are found, what happens when supplemented with vitamin E. The buccal cells and     serum of patients will be collected for the estimation of vitamin E both before and after     supplementation with vitamin E. Similar samples will be collected from similar number of     arsenic exposed controls and healthy volunteers for comparison.   "
117874|NCT01743053|"     This is a prospective, randomised, open label, controlled pilot study to evaluate the safety     and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for     the management of chronic leg ulcers associated with venous insufficiency. Outcome will be     compared between study participants receiving standard care (debridement, compression     therapy) and participants receiving ReCell in addition to standard care.   "
117875|NCT01743040|"     This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the     performance of the CADence device in detecting the existence of clinically significant     coronary artery disease.   "
117876|NCT01743027|"     The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular     itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge     (CAC) model.   "
117877|NCT01743014|"     The purpose of this study is to determine whether the combination with ramipril and     clopidogrel leads to further improvement of endothelial function, reduction of oxidative     stress and reduction of vascular inflammation, compared with ramipril monotherapy, in     patients with Diabetes Mellitus type 2 and diabetic nephropathy.   "
117878|NCT01743001|"     Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects     with Eisenmenger Syndrome.   "
117879|NCT01742988|"     This is a phase I, open-label, dose-escalation study of CUDC-907 in patients with refractory     or relapsed lymphoma or multiple myeloma. CUDC-907 is a multi-targeted agent designed to     inhibit phosphoinositide 3-kinase (PI3K)and histone deacetylase (HDAC). The study is designed     to assess the safety, including the maximum tolerated dose, biologically effective dose, the     pharmacokinetics, and the anti-cancer activity of CUDC-907.   "
117880|NCT01742975|"     A randomized prospective simple-blind interventional study evaluating the efficacy of the     synthetic adhesive solution Ifabond, in patients undergoing breast cancer surgery. The main     objective of this study is to determine if the application of Ifabond, in addition to the     conventional method of breast surgery, reduces the postoperative seroma formation. The     secondary objective is to assess quality of life immediately after surgery, and the need for     needle aspiration of the axilla, when using Ifabond.   "
117881|NCT01742962|"     The purpose of this exploratory data collection is to strengthen our knowledge of some of the     rarer distresses following surgical removal of the prostate. In general these are:        -  Side effects related to sexuality, including:        -  Altered perception of orgasm,        -  Orgasm associated pain,        -  Penile shortening and deformity.        -  Side effects related to urinary incontinence.        -  Urinary tract infection after operation.        -  Influence of distress on sexual quality of life.        -  Influence of distress on the patient´s sex drive.      In addition information on a range of demographics and information on the patient´s erectile     function will be collected.   "
117882|NCT01742949|"     This study aims to investigate the benefits of using first line heated humidification. The     primary objective of this research is to determine the effect of high levels of     humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it     is possible to predict which patients benefit the most (i.e. be more adherent with therapy)     from high levels of humidification delivered by ThermoSmart.   "
117913|NCT01742546|"     To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical nerve     stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome in     upper trapezius muscle measured by mean change between pre and post treatment of pressure     pain threshold (PPT), patient's complaint in pain intensity and the number of total tablet     usage of acetaminophen in both groups.   "
118016|NCT01741207|"     We designed this study to evaluate the effect of N-acetylcystein on biomarkers of platelet     activation , cardiac necrosis and coronary reperfusion in patients undergoing percutaneous     coronary intervention.   "
117883|NCT01742936|"     The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and     compare obtained results versus standard laboratory coagulation parameters prothrombin time     (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results     will also be examined. A total of 100 pediatric patients undergoing spinal surgery or     cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be     obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck®     device. If the two results are comparable, this could have immediate clinical application and     impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2     hours for standard laboratory samples.   "
117884|NCT01742923|"     Patients with hypertension have an increased risk of stroke and myocardial infarction.     However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs     frequently within this patient group. The purpose of this study is to investigate whether a     complex tailored intervention in a hospital setting will lead to increased medication     adherence and fewer cardiovascular events when compared to a usual care group. Interventions     focus on motivational interviewing, medication review and telephone follow up.   "
117885|NCT01742910|"     Age-related cataract is the main cause of impaired vision in the elderly population     worldwide. In the UK, more than half of people who are over 65 have some cataract development     in one or both eyes. The only treatment that can restore functional visual ability is     cataract surgery where the opacified crystalline lens is removed by phacoemulsification and     an artificial intraocular lens is implanted. It is estimated that around 10 million cataract     operations are performed around the world each year. Cataract operations are generally very     successful, with a low risk of serious complications. The most common risk is developing a     condition called posterior capsule opacification (PCO), which causes impaired vision to     return.      During the past two decades, cataract surgery underwent tremendous change and modernisation     resulting in today's small incision phacoemulsification surgery and a safe technique with a     short rehabilitation time for the patient. The most frequent long-term complication of     cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,     refinements in surgical technique and modifications in IOL design and material have led to a     decrease in the incidence of PCO.      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial     cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule     opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic     towards the end of the production process, also called multipiece designs.      For several reasons such as better ease of use with injector systems and higher efficiency in     the production process, companies have developed IOLs with open-loop haptics out of one block     of material, also called single-piece designs. In the case of such single-piece IOLs, the     haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick     haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending     effect of the posterior capsule around the posterior optic edge. Additionally, the posterior     sharp edge is often discontinuous in the region of the haptic-optic junctions. These     locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO.     Nowadays a multitude of different single piece IOLS are available, many of them similar but     of course with some differences in regard to the chemical composition of the acrylic material     and the IOL design.      The purpose of this study is to compare the intensity of posterior capsule opacification     (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)     with different design of the sharp posterior edge within a follow up period of three years.   "
117888|NCT01742871|"     Bleeding under vitamin K antagonists are a major iatrogenic causes of hospitalization,     subject to a fatal outcome in more than one third of cases, mortality is particularly high in     cases of serious bleeding, including intracerebral hemorrhage. If the INR measured in these     patients are often away from the higher value of the target range, a significant proportion     of bleeding were observed for INR between 2 and 3. The study captures the components of the     nutritional status of patients on oral anticoagulants, including any micronutrient     deficiencies, to determine whether nutritional status is an independent risk factor for     bleeding   "
117889|NCT01742858|"     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in     three age groups.   "
117890|NCT01742845|"     The aim of this prospective, randomised, controlled study is to compare the efficacy of     ultrasound-guided intermediate cervical block to superficial block for carotid     endarterectomy.      Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75     mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed:     superficial cervical block (Control group) or, ultrasound guided intermediate cervical block     (Echo group). Main outcome is cervical block success, defined by surgery performed under     regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of     conversion to general anaesthesia, total dose of supplemental topical lidocaine and     block-related complications.   "
117891|NCT01742832|"     The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the     treatment of major depressive disorder versus citalopram. Doctors want to determine if     vilazodone is effective for the treatment of major depressive disorder in those who have not     responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of     anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and     citalopram have been approved for the treatment of major depressive disorder. This research     is being done because the researchers want to find out if vilazodone works in reducing the     symptoms of depression significantly more than a generic SSRI.   "
117892|NCT01742819|"     Glaucoma is one of the leading causes of blindness in the world. The key to prevention of     visual loss from glaucoma is early detection of the disease or its progression and timely     treatment. The proposed study will investigate the role of various tests in improving     detection of disease progression in advanced glaucoma. Evaluation of the peripheral field of     vision (visual field examination) remains the current standard for detection of progression     in glaucoma. However, there is a lot of variability or inconsistency in eyes with advanced     glaucoma, which could make it difficult to detect worsening of glaucoma with visual fields.     The optic nerve demonstrates significant damage in such eyes and hence oftentimes repeat     imaging of the optic nerve head is not helpful for detection of change. Therefore, imaging of     the central retina (the innermost sensitive tissue lining the inside of the eye), called     macula, has been proposed to supplant imaging of the nerve in eyes with severe glaucoma. The     macula aids in detailed central vision. Since the macular retinal neural cells are the last     ones to be affected in glaucoma, measurement of macular retinal thickness could provide     significant information with regard to the course of glaucoma. In the proposed study,     glaucoma patients will be tested and followed with various measurements done with newer     versions of optical coherence tomography (OCT) imaging and visual field machines. The     patients will undergo repeat imaging and visual field testing every 6 months over the course     of 5 years. Rates of change will be estimated. We will explore if changes in various outcome     measures derived from imaging are correlated with the corresponding visual field changes in     glaucoma, and whether the former can be used as an alternative method for detecting     simultaneous or subsequent glaucoma progression. The hypothesis for this proposed research is     that macular OCT parameters are valid structural measures that can be used especially in     advanced disease to follow the course of glaucoma.   "
117893|NCT01742806|"     This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce     and shortens time until drain removal after minimally invasive surgery for early gastric     cancer.   "
117894|NCT01742793|"     The study hypothesis is that lenalidomide and romidepsin (and dexamethasone for patients with     myeloma) will have an acceptable toxicity profile and that in combination will have     sufficient activity in the target population (including those previously refractory to HDACi     monotherapy) to warrant further investigation.   "
117896|NCT01742767|"     Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced     and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth     factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of     a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and     often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on     Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing     chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable toxicity     profiles and generally with an excellent patient compliance.   "
117897|NCT01742754|"     Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked     by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by     shifting the recipient's microbiota toward a eubiotic microbial community that resists     colonization by pathogenic organisms or decreases its inherent inflammatory properties.     Several studies now report its efficacy in treatment of severe Clostridium difficile colitis.     Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success.     This is corroborated by several lines of evidence suggesting dysbiosis plays an important     role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel     syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to     which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic     or immunologic factors in UC leading to selection pressure preventing a change in the     microbiota. As an initial step into investigating the potential efficacy of stool transplants     for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and     stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.   "
117898|NCT01742741|"     An unblinded, randomized, cross-over design with each patient participating in two 40-hour     outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)     Control using Continuous Glucose Monitor (CGM)-augmented insulin pump treatment outside of a     hospital based clinical research center.   "
117899|NCT01742728|"     we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers,     cytokines, and periodontitis through community-based study held in the Goto city, Japan.   "
117900|NCT01742715|"     To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three     commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS     network algorithm.   "
117904|NCT01742663|"     The objective of this study is to compare the relative efficacy and safety of the test     formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation     Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis.      Both the test and reference formulations will also be compared to a placebo formulation to     test for superiority.   "
117905|NCT01742650|"     The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA     Weber C ankle fractures. Our hypothesis is that 50% of screw fixed fibulas but only 5% of     suture-button fixed fibulas are in malposition. All skeletally mature patients (16 years or     older) with AO/OTA Weber C type fractures operated within a week after trauma are     consecutively included into the study. The tibiofibular transfixation is randomly performed     either by a 3,5 mm tricortical screw or a suture-button (TightRope). Malposition of the     tibiofibular joint is assessed in an intraoperative computed tomography. Clinical outcome is     assessed by using Olerud-Molander, RAND ja 36-Item Healt Survey after 1-year from the injury.   "
117906|NCT01742637|"     The objective of this study is to evaluate the therapeutic equivalence and safety of     Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo®     (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment     of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and     reference products over the vehicle (placebo) control in the treatment of acne vulgaris.   "
117907|NCT01742624|"     To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release     Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and     the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients     1 month after kidney transplantation.   "
117908|NCT01742611|"     This is a multi-center, open-labeled, non-comparative study to examine the safety and     efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with     hyperphosphatemia not on dialysis.   "
117909|NCT01742598|"     The purpose of this study is to assess the safety and performance of the 23mm Portico     Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe     symptomatic aortic stenosis   "
117910|NCT01742585|"     This is a randomized, double blind, placebo-controlled multi-center study to examine the     efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not     on dialysis.   "
117911|NCT01742572|"     Several studies have shown differences in health-related outcomes by dietary pattern. These     patterns have included those participants following vegan (no meat, poultry, fish, dairy, or     eggs), vegetarian (no meat, poultry, or fish), pesco- vegetarian (no meat or poultry),     semi-vegetarian (red meat and poultry ≥ 1 time/month and < 1 time/week), or omnivorous diets.     These studies have shown that of these dietary patterns, vegans have the lowest BMIs, lowest     prevalence of Type 2 diabetes, and lowest amount of weight gain over 5 years. In addition,     vegetarians have significantly better metabolic risk factors as compared to non-vegetarians.     While these initial observational studies have shown benefits to consuming more plant-based     diets, there have been no randomized trials examining the differences in health outcomes     among these dietary patterns. To begin exploring this research area, the investigators will     conduct a pilot study which will randomize participants to one of the 5 dietary approaches.     Participants (n=75) in the NEW DIETs Study will be recruited to follow their randomly     assigned diet for 8 weeks and attend weekly sessions to learn about nutrition and cooking.   "
117912|NCT01742559|"     Anesthesia of the soft and hard tissues in the maxilla may require up to five injections.     Thus, the aim of the present study was to evaluate the anesthetic efficacy in buccal tissues     after the use of the anterior middle superior alveolar (AMSA) and supraperiosteal techniques     during subgingival scaling and root planning (SRP).   "
117914|NCT01742533|"     Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum     gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important     physical and psychological consequences/impact in those patients.      Premature ovarian failure (POF) is currently managed by non-physiological sex steroid     regimens which are inadequate at optimizing uterine characteristics.      Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells     (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance     angiogenesis, suggesting the novel and promising therapeutic strategy for POF.      In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with     Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure.     Participants will be followed for an expected average of 48 weeks.   "
117915|NCT01742520|"     The purpose of this study is to determine the effect of sucrose 24% for pain prevention on     preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful     procedure,do not impair neurodevelopmental outcomes of preterm infants   "
117916|NCT01742507|"     Stent coverage and neo-intimal growth can be evaluated in-detail by intracoronary optical     coherence tomography (OCT), which is a catheter-based imaging technique. It is performed as     part of the PCI procedure. OCT is the optical analogue of intravascular ultrasound (IVUS),     except that it can provide much higher resolution of coronary cross sectional images than     IVUS. The LightLab C7XR OCT system (Frequency Domain OCT) used in this Hospital has obtained     full CE Mark, approved by the US FDA, and approved for clinical use in Hong Kong. It has been     shown to be safe in clinical settings and has been used in over 300 patients without     complication at Queen Mary Hospital.      In this study, stent coverage and neo-intimal growth between zotarolimus-eluting stents (ZES)     and biolimus-eluting stents (BES) will be compared by using OCT at 9 month and specific     post-intervention re-study intervals.      The investigators objective is to investigate the clinical impact and OCT difference on early     stent healing and late lumen loss between the two new-generation limus-eluting-stents -     Resolute Integrity and Biomatrix, which differ in stent design, eluting drug and coating     polymer.   "
117918|NCT01742481|"     The proposed study is part of a career development award. The first two phases of research     involve collaborating with adult survivors of childhood cancer representing both sexes and     three ethnic/racial groups (African American, Hispanic, and White). THe collaboration will     focus upon developing educational material that is helpful in teaching survivors about health     risks related to cancer treatments and about survivorship care. The third phase is a     randomized controlled trial that will randomly (like a flip of coin)place survivors into one     of two groups. One group will meet in -person with a group leader three times, once each week     over three weeks. The other group will receive an information packet that contains websites,     books, and resources similar to content provided in-person within a group format to the other     group. The goal is to help adult survivors get involved in specialized healthcare so they can     remain healthy. This involves getting a copy of their medical record to understand what     treatments they received and working with health providers to get an individualized     survivorship care plan.   "
117919|NCT01742468|"     The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA     supplemented products (sausage, tomato spread, milk beverage) on disease activity,     inflammatory markers, and cardiovascular risk factors in patients with rheumatoid arthritis.   "
117920|NCT01742455|"     Concerning the promotion of peripheral collateral growth, clinical studies investigating new     therapeutic strategies have used imprecise assessment methods and therefore determined only     weak endpoints. In contrast to the coronary circulation, there is currently no gold     standard available to document successful promotion of collateral growth in patients     suffering from peripheral artery disease. Therefore, the purpose of this study is to evaluate     a new invasive method to quantify arterial collateral flow in the lower extremity in patients     undergoing elective coronary angiography.   "
117921|NCT01742442|"     About 50% of cancer patients are >70 years at diagnosis. Age related somatic and psychiatric     problems may influence the course of cancer and its treatment. The present study is a     prospective observational study. Age related problems will be assessed by clinical frailty     indicators covering areas that are recommended in geriatric oncology. The aim is to describe     the frequency of age related problems in a cohort of Norwegian cancer patients > 70 years of     age, to investigate the predictive/prognostic impact of these indicators on cancer and     treatment related morbidity and mortality, and to investigate the association between     clinical frailty indicators, sarcopenia (severe loss of muscle mass) and inflammatory     response. Patients are recruited at outpatient cancer services, Innlandet Hospital HF (SI),     Oslo University Hospital, and Akershus University Hospital. Estimated sample size is 300 with     30 months inclusion and 2 years follow-up. The study emerges from SI in collaboration with     several external national and international centres   "
117922|NCT01742429|"     To test the efﬁcacy of 14 day levoﬂoxacin and bismuth-containing second-line therapy for     resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.   "
117923|NCT01742416|"     Arterial cannulation is a commonly performed invasive procedure in the operation room, the     emergency department, and in the intensive care unit. The indications include the need for     continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated     blood sampling for laboratory evaluation. This procedure can be challenging even in the best     of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse     may, however be weak or absent in patients with hypotension, edema, obesity or local     thrombosis due to previous arterial cannulation in the same location. Furthermore, the     catheter may not be passed successfully into the artery, despite apparent good blood return     on initial puncture, or hematoma and spasms of the artery may develop after failed attempts,     thus making further attempts even more difficult. While ultrasound (US) is being used with     increasing frequency for central venous access, fewer clinicians are familiar with US-guided     arterial catheterization. The aim of this study is to investigate if ultrasound facilitates     arterial cannulation in children ≤24 months compared with the palpation method and to     investigate the potential extra costs/savings of introducing the method. This study     hypothesizes that the ultrasound method will facilitate arterial cannulation in small     children compared with the palpation method.   "
117927|NCT01742364|"     The study is designed to test the hypothesis that BCG administration via jet injector will     produce a comparable immune response and that there will be no significant differences in     safety or reactogenicity between BCG administration via jet injector and needle and syringe.      The primary objectives of this study are to...        1. Compare the safety and reactogenicity of BCG administered intradermally by a jet          injector device in adults and infants, to BCG administered intradermally by needle and          syringe;        2. Compare the specific T cell immunity in neonates vaccinated with BCG via the jet          injector device to infants vaccinated with BCG via needle and syringe.   "
117928|NCT01742351|"     The aim of the study is to test the feasibility and acceptability of internet-based Cognitive     Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to     treat residual depressive symptoms as well as using psychoeducation to improve their     prognosis. Each participant will have a personal therapist that will provide guidance and     support throughout the treatment.   "
117929|NCT01742338|"     COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by     long-term smoking. COPD can get worse, making people sick enough to need hospitalization.     Corticosteroids are very effective and are almost always used, but nobody knows the right     dose. High doses may work better but could cause more side effects than low doses. Typical     treatment lengths last at least one week. This study will be comparing two common regimens:     either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high     dose). It is unknown which regimen works better..   "
117930|NCT01742325|"     Specific aims:      Control group(2010/1~2011/6)： Aim 1: Describe the patterns of fatigue, sleep disturbance,     and pain in children with cancer from perspectives of children and their parents over the     course of one cycle (five days) of inpatient chemotherapy (CXT).      Aim 2: Determine, at various time points (during they are hospitalization various four     times), the associations between fatigue, sleep disturbance, and pain over the course of four     cycles (there are five days in each cycle) of CTX in children with cancer.      Aim 3: Examine the associations between a symptom cluster of fatigue, sleep disturbance,     pain, child reported Quality of Life for Children with Cancer (QOLCC), parent reported     uncertainty and QOL, and biomarkers over the course of four cycles of CXT in children with     cancer.      Intervention group(2011/7~2012/12)： Aim 4: To test an intervention program (two 20-minute     sessions of walking around the nurse's station daily, five days a cycle) to reduce the     symptoms of fatigue and pain and increase quality of sleep.   "
117931|NCT01742312|"     Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an     operation to remove the tumour. Chemotherapy has several effects upon the body, including     effects upon the systems that control the creation and breakdown of muscle. We aim to review     these effects by recording changes in the amount of exercise patients are able to undertake     after chemotherapy and reviewing changes in muscle mass.   "
117932|NCT01742299|"     The purpose of this study is to allow continued use of imatinib in patients who are on     imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs     (CD&MA) study and are benefiting from the treatment as judged by the investigator.   "
117933|NCT01742286|"     The purpose of this study is to estimate the maximum tolerated dose and/or recommended dose     for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor     activity and characterize single and multiple-dose pharmacokinetics when administered orally     to pediatric patients with ALK-activated tumors, with and without food.   "
117934|NCT01742273|"     Patients on hemodialysis (HD) exhibit an immensely increased cardiovascular mortality     associated with extensive vascular calcification (VC). In the past years the development of     VC was discovered to be actively regulated and as being influenced by inhibitors of     calcification (e.g. matrix-Gla-protein, fetuin-A). MGP is produced by vascular smooth muscle     cells and needs post-translational modification by vitamin K dependent gamma-carboxylation to     be fully active. Based on the demonstration of increased PIVKA-II levels, about 97% of all HD     patients exhibit insufficient carboxylation activity. We therefore aim in this randomized,     controlled study to retard the progress of coronary and aortal calcification as assessed by     thoracic multislice-CT by the thrice weekly administration of 5 mg vitamin K1 (phylloquinone)     to a total of 348 HD patients over a period of 18 months.   "
117935|NCT01742260|"     Formal study hypothesis:      Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will     result in the patient producing their own bone to fill the void which will reduce the risk of     infection and resorption, lead to a better cosmetic result and obviate any long term     consequence of having a synthetic material in vivo.      Introduction:      There are several reasons that parts of the skull may need to be removed:        -  After trauma to relieve brain swelling        -  During brain surgery (for brain cancer)        -  After trauma where the bone is so badly fractured/fragmented it needs to be removed.      In all but the last case the bone flap is temporarily stored in a freezer and once the brain     swelling has subsided it is reinserted. This procedure is called autologous cranioplasty;     autologous, because it originally came from the patient and cranioplasty, referring to the     repair. Although this is a straightforward procedure, there are a number of complications     including infection and bone resorption that can occur.      This study:      Stromal cells have a proven ability to aid in bony healing. Furthermore stromal cells on a     ceramic framework encased in a plastic scaffold have been shown in a small clinical trial to     lead to healing of skull defects. In the present study, it is proposed to add stromal cells     from a suitable donor to medical grade ceramic granules, place them in between specially     moulded plastic scaffolds and insert the sandwich into the skull. Both the ceramic and     plastic materials are medical grade and commonly used in reconstructive surgery, the ceramic     for packing into bony defects due to trauma or removal of cancer and the polymer in bony     reconstruction. Both materials are approved by the TGA. They are designed to dissolve away     over time as the body's own blood vessels and cells populate the sandwich and create the     patient's new bone. It has been proven that without the encouragement of the cells and     temporary scaffold materials, a hole in the skull will not heal. Given the incidence of bone     resorption/infection and metal plate infection using traditional methods, it would seem     prudent to provide a construct that will allow controlled replacement with the patient's own     bone, thus negating any adverse long-term complications with synthetic materials that remain     for life.   "
117936|NCT01742247|"     Assessment of needs of moisturizers after various laser treatments   "
117937|NCT01742234|"     An organ transplant is frequently the best option and, in some cases, the only option to save     the lives of transplant recipients. Receiving an organ from a living donor eliminates the     need to wait for a deceased donor, an option that many transplant recipients do not survive.     However, donating an organ presents health concerns to the donor as well. This study will use     surveys to evaluate the understanding of risk and psychological pressure that living organ     donors felt when making the decision to donate. It will also compare participants' answers     across geographic, racial and socio-economic backgrounds.   "
117938|NCT01742221|"     This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of     HemaMax in healthy male and female volunteers.   "
117941|NCT01742182|"     Disruption of sleep and alertness is one of the most disabling non-motor symptoms of     Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not     well understood, and treatment options remain limited. The proposed research will examine     markers of the circadian system, sleepiness and sleep quality in PD patients and healthy     controls. Further, the project will examine effects of bright light exposure on circadin     function, sleep and alertness in PD.   "
117970|NCT01741805|"     Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is     defined in the literature as asthma not controlled by medication. In recent years it has     become known that severe asthma is a variable disease and has subtypes relating to the age of     onset, type of inflammation and allergy, obesity, etc.      Our aim is to characterize the phenotypes of severe asthma population in our clinic and     compare the prevalent phenotypes to the phenotypes described before.   "
117942|NCT01742169|"     The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)     screening using fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy, beginning at     age 50 and continuing until age 75. Despite this recommendation, rates of CRC screening     remain inadequate and large disparities exist. Screening rates are lower among Black and     Hispanic populations, in areas with high poverty rates, among individuals with low education,     and for those who utilize Medicaid or lack health insurance. This study will determine the     effectiveness of a multifaceted intervention to increase the number of patients who have     never been screened for CRC and are cared for at a community health center (CHC) that     complete a fecal immunochemical test (FIT) within 6 months of randomization to an     intervention group compared to patients in a usual care group. We believe that the proposed     intervention will improve the CRC screening rate in a cost-effective and sustainable way,     ultimately leading to a reduction in the high rate of CRC.      Aim 1: To conduct a randomized controlled trial to determine if a multifaceted intervention     increases the proportion of patients who complete a FOBT within 6-months of randomization.      Hypothesis 1: Compared to usual care, the intervention will increase the proportion of     never-screened patients who complete FOBT within 6 months of randomization.      Aim 2: Assess the costs of the intervention and the costs per additional initial screening     compared to patients who receive usual care.   "
117943|NCT01742156|"     Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non     invasive methods documented in the literature as early signs of coronary artery disease. We     wish to study the sensitivity and specificity of both signs by conducting a single blind     study involving patients with documented presence or absence of coronary artery disease via     angiogram.   "
117944|NCT01742143|"     The purpose of this 1 year study is to see if the ICCAN program is working, and to compare     the ICCAN program to the standard hospital services provided in New York City hospitals, like     meeting with a Social Worker or a Patient Navigator (a person who provides personal hospital     guidance).   "
117945|NCT01742130|"     The purpose of this study is to determine whether hydration with sodium bicarbonate is more     effective than hydration with sodium chloride to prevent contrast nephropathy in patients     undergoing primary coronary intervention for acute ST elevation myocardial infarction.   "
117946|NCT01742117|"     Clopidogrel is an anti-platelet medication approved by the U.S. Federal Drug Administration     (FDA) for use in patients who undergo Percutaneous Coronary Intervention (PCI) with coronary     stent implantation. Anti-platelet medications work to prevent blood clots from forming. Some     studies have suggested that patients who have a certain genetic liver enzyme abnormality     (known as cytochrome P450 2C19 [CYP2C19] *2 or *3 allele) may have a reduced ability to     activate clopidogrel, and therefore may have a lowered response to clopidogrel. It is thought     that perhaps people who have a coronary stent procedure may have this genetic liver enzyme     abnormality. There is a research genetic test available to determine whether or not someone     has this genetic liver enzyme abnormality. Ticagrelor, is a newer anti-platelet drug that is     not dependent on the CYP2C19 liver enzyme for its activation and hence in poor clopidogrel     metabolizers, alternative drugs like Ticagrelor have been recommended for use as an     anti-platelet agent after PCI. The purpose of this study is to determine if genetic testing     can identify the best anti-platelet therapy, for patients who undergo a coronary stent     placement and do not activate clopidogrel very well.   "
117947|NCT01742104|"     The study aims to evaluate the quality of life (QoL) of patients affected by Primary     Open-Angle Glaucoma (POAG), using 2 QoL questionnaires:        1. Glaucoma Symptom Scale (GSS) and        2. National Eye Institute Visual Function Questionnaire (NEI-VFQ -25). The study will be          conducted on patients with well known diagnosis of POAG (transversal phase) and on          patients with first diagnosis of POAG (longitudinal phase).   "
117948|NCT01742091|"     The purpose of this study is to assess the safety and side effects of multiple doses of     LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin)     and intravenously (directly into a vein). The study will also test how long it takes the     study drug to get into the body, how long it takes the body to get rid of it, the overall     effect of the study drug on the body, and whether antibodies to the study drug are formed.   "
117949|NCT01742078|"     The purpose of this study is to determine if a single dose of LY2541546 has any side effects     on the body and to determine how long and how much LY2541546 stays in the bloodstream of the     body.   "
117977|NCT01741714|"     This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for     migraine. If the method proves to be effective, it will provide a new non-pharmacological     treatment option for migraine. This is especially important since some migraineurs do not     tolerate acute and/or prophylactic medicine, due to side effects or contraindications due to     comorbidity of other diseases while others do not have effect. Thus, alternative treatment     options are warranted. The applied methodology of the study will aim towards the highest     possible research standards. This international study is a collaboration between Akershus     University Hospital, University of Oslo (UiO), Norway and Macquarie University, Australia.     The multidisciplinary professional backgrounds are physiotherapy, chiropractic and medicine.     By increasing the methodological quality of the investigators research to a very high level,     the investigators see the method to work as a guide to increase the quality of chiropractic     research in the future, as previous randomized clinical trials (RCTs) of migraine used     methodology showing room for improvement.   "
117950|NCT01742065|"     Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC)     screening according to guidelines set by the federal government. CRC is 90% curable with     timely detection and appropriate treatment of precancerous polyps; increased screening could     reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal     education, low income, low access to health care, recent immigrants or Hispanics, are the     same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs).     The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is     exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages     and target rates. Our results will provide valuable information on how to use electronic     health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose     patient populations have disproportionately low CRC screening rates.      This project, in conjunction with the research team, will use an advisory panel to direct the     research activities. The advisory panel will be made up of clinicians, leaders, researchers,     and patients. The panel and team will guide the development of materials, the outreach to     patients, and the research protocol to best reach FQHC patients who are due for colorectal     cancer screening.      This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's,     and Phase II is rolling out the intervention to between 20-30 clinics.   "
117951|NCT01742052|"     The primary objectives of the study are:        -  To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a          period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI          parameters        -  To evaluate the safety and tolerability of three oral doses of MT-1303 compared to          placebo given for a period of 24 weeks in subjects with RRMS.   "
117952|NCT01742039|"     The primary aim of this study is to determine the safest and most effective therapeutic     strategy to decrease the incidence of postoperative atrial fibrillation following cardiac     surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to     evaluate the length of hospital stay associated with each treatment strategy.   "
117954|NCT01742013|"     GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino     acids, peptides, nucleobases, and carbohydrates. This product is approved for improving liver     function. Also, it has been prescribed for lots of diseases such as menopausal disorders,     atopic dermatitis, skin cares as well as fatigue for long time. Although its action mechanism     and clinical effectiveness are not still clear, there are reports which say a strong     probability of its clinical effectiveness in the chronic fatigue patients.      This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta     hydrolysate) in the chronic fatigue patients through a randomized controlled tial.   "
117955|NCT01742000|"     The purpose of this study is to investigate the anti-atherosclerotic action of natural drug     Karinat based on phytoestrogen-rich botanicals in postmenopausal women.   "
117956|NCT01741987|"     The purpose of this project is to determine the effectiveness of an eyewash osmoprotective     lubricant comparing to castor oil containing and non-osmoprotective lubricants in different     types of DTS and post refractive surgery patients.   "
117957|NCT01741974|"     The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric     action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal     women.   "
117958|NCT01741961|"     Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are     retrospectively examined.   "
117959|NCT01741948|"     There have been reports in the medical literature demonstrating a link between the     development of provoked vestibulodynia (PVD), a sexual pain disorder, and hormonal     contraceptive (HC) use. The purpose of this pilot study is to assess the prevalence of HCs     induced PVD among a HC naïve population, to evaluate which of the components of the HCs are     associated with a higher risk of the development of PVD, and to evaluate which clinical and     genetic factors predispose the patient to HCs induced PVD. Assessments will be made through     patient questionnaires, physical examinations, and blood tests. Microarray techniques will be     employed to characterize, on a global level, the gene expression profiles of women who     develop PVD in comparison to those who do not develop PVD. Patients will be followed for a     year. Results will be used to develop a larger clinical trial.   "
117960|NCT01741935|"     An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and     monitor the progression of a patient's COPD.      Chronic Obstructive Pulmonary Disease (COPD) affects growing patient groups. Current     knowledge about the disease limits the investigators ability to cure or interfere with the     progression of the disease. COPD is often characterized by exacerbating infections requiring     emergency care.      The project aims to examine whether disease progression of COPD can be better controlled by     continuously monitoring the patient's physical activity, along with the assessment of     pulmonary symptoms and lung function. A key question is: can investigators find indicators     that provides support for early intervention before severe symptoms arise.      The patient carries a smartphone that records physical activity real-time, daily lung     function measures, lung disease related symptoms, and use of medication.      The experimental phase, the first part of the project, covers 25 COPD patients followed up to     12 weeks where the primary objective is to examine and verify both new investigational     methodology and technology.   "
117961|NCT01741922|"     The goal is to investigate in patients with high blood pressure, BP, namely, those with     systolic blood pressure and diastolic blood pressure, SBP/DBP higher than or equal to 140/90     mmHg, and high cardiovascular risk, under treatment with low-dose acetylsalicylic acid, ASA,     whether changing the time they take the drug (same dose) to bedtime (from taking it at some     point during the active part of the day) produces a drop in their blood pressure (mean     systolic and diastolic over 24 hours) of at least 2.5 mm Hg; and also whether among     non-dippers, under secondary treatment with low-dose ASA, there is be a greater decrease in     their night BP when the drug is taken in the evening.   "
117962|NCT01741909|"     Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The     investigators believe that intravenous therapy is prolonged more that necessary and that oral     therapy can be used much earlier in the course of the disease. The investigators plan to     check if that statement is true and intervene in order to shorten the intravenous therapy.   "
140159|NCT01450111|"     Primary objective of this trial was to investigate the pharmacokinetics of single dose and     repeated dose applications of lacosamide in healthy male Korean subjects.   "
117963|NCT01741896|"     Computated tomography (CT) is an invaluable medical resource for both physicians and     surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an     incredibly powerful means of imaging the human body, there are possible complications to the     use of contrast including a hypersensitive response and contract induced nephropathy (CIN).     The latter will typically occur 48-72 hours after administration.      One recent meta - analysis of serum creatinine levels following contrast enhanced CT found     6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 %     had a persisting reduced renal function, with a small minority needing renal replacement     therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of     contrast given.      The mechanism of injury to the kidney is not definitively established, but is thought most     likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free     radicals causing direct damage to the kidney and also direct tubular damage.      Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced     transient ischaemia at another site could buffer the impact of the contrast medium's effects.     This was first demonstrated during cardiac angiograms, with those patients whom received     multiple balloon inflations in the coronary arteries were found to have a lower incidence of     CIN than those with fewer balloon inflations. Thus it could be hypothesised that any     ischaemia temporarily induced could be nephroprotective. This can be at a point of extremity,     rather than involving central organs, such as the arm, with ischaemia induced by the use of a     blood pressure cuff, inflated to above systolic blood pressure levels.      No studies have been found in the literature attempting to demonstrate this effect in     relation to contrast CT studies. Consequently, a randomised control clinical trial of     patients to assess the effectiveness of remote ischaemic preconditioning is proposed.      Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs     involving IV contrast is nephroprotective.   "
117964|NCT01741883|"     The purpose of this study is to evaluate a side effect prevention training (SEPT) that     optimizes patients' response expectations before the start of adjuvant endocrine treatment     (AET) to prevent nocebo side effects and enhance quality of life during longer term drug     intake.   "
117965|NCT01741870|"     To examine the effectiveness of a need-based nutritional intervention strategy in improving     the nutritional and physical functional status of nursing home elderly.   "
117966|NCT01741857|"     This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived     mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory     systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments.     The underlying hypothesis is that the active SLE condition is caused by an abnormal immune     homeostasis that can be restored by MSCT.   "
117972|NCT01741779|"     Obesity is a major risk factor for premature arterial abnormalities including high blood     pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle     modifications is associated with a decrease in large artery (aorta) stiffness. However, along     with decreases in fat mass, hypocaloric diet reduces muscle mass. Whole body vibration     results in similar increases in muscle mass and strength than those observed after resistance     exercise and is feasible for special populations such as the obese and the elderly.      The investigators hypothesis is that weight loss via diet combined with whole body vibration     training would additively reduce arterial stiffness and blood pressure in obese women. The     investigators also hypothesize that the improved arterial function with weight loss would be     associated with beneficial changes in the main mechanisms involved in BP regulation.   "
117973|NCT01741766|"     Hypertension is a major risk factor for cardiovascular disease. Hypertension and abdominal     obesity are associated with dysfunction of the main mechanisms of cardiovascular regulation,     the autonomic nervous system and the vascular endothelium. Increased sympathetic activity and     endothelial dysfunction are associated with increased arterial stiffness, which is an     independent risk factor for the development of hypertension and other cardiovascular     diseases. The recommended intervention for controlling BP in pre- and stage 1- hypertensive     individuals is lifestyle modifications such as exercise, and not drug therapy.Although     aerobic and resistance exercise has been shown to be beneficial for the cardiovascular     system, special populations such as the elderly and obese may have physical and/or     musculoskeletal limitations which may limit their participation in these exercise modalities.      Stretching is a form of exercise that is widely recommended for injury prevention. Among the     benefits of stretching are an increased flexibility, enhanced muscular coordination, stress     relief, improved range of motion and an improved posture. Previous studies have shown     stretching training to increase arterial compliance and acutely increase sympathetic nerve     activity. In addition, low flexibility levels have been found to be associated with arterial     stiffness. Given that stretching of skeletal muscle causes an increase in sympathetic nerve     activity; repetitive stimulation of sympathetic activity induced by habitual stretching,     might chronically reduce resting sympathetic activity. The reduction in sympathetic activity     might result in a decrease of arterial stiffness and blood pressure.      The investigators hypothesis is that 8 weeks of stretching training would reduce arterial     stiffness, blood pressure and sympathetic activity in obese women. The investigators also     hypothesize that the improved arterial function with stretching would be associated with     increases in flexibility levels.   "
117974|NCT01741753|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational drug, in this case an investigational drug combined with standard drug     therapy. Phase I studies also try to define the appropriate dose of the investigational drug     to use for further studies. Investigational means that the drug is still being studied and     taht research doctors are trying to find out more about it. It also means that the FDA has     not approved the drug for use in patients, including people with your type of cancer.      BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to     better outcomes in many types of cancer.      Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and     works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone     acetate, individuals must also take a glucocorticoid such as prednisone.      Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel,     after which treatment with the combination of abiraterone and prednisone has been shown to be     effective. Evidence has shown an interaction between the pathways through which BKM120 and     abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant     prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The     purpose of this study is to determine a safe dose for the combination of daily oral BKM120,     abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate     cancer who have received prior treatment with docetaxel.   "
117975|NCT01741740|"     There are only little data on the risk of chronic complaints (pain and discomfort) following     open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and     secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly     recurrence. The setup was a retrospective two-centre study including patients ≥18 years     undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The     survey included questions on suspicion of recurrence, reoperation for recurrence (if yes     patients were examined by a consultant in patients home), pain, discomfort, work, and leisure     activities. We analysed 295 consecutive patients through a non-validated structured     questionnaire.   "
117976|NCT01741727|"     A study of ABT-414 in subjects with solid tumors.   "
117978|NCT01741701|"     The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective     treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and     complete two safety follow-up phone calls over a 4 month period.   "
118032|NCT01740999|"     The operational and favored standard therapy for the treatment of osteoarthritis in the     distal interphalangeal joint is the arthrodesis, in which a titanium screw is used.     Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low     loss of function. But restrictions are reported in fine motor skills.      The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used,     which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal     joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal     joint and the resulting improved fine motor skills.   "
118033|NCT01740986|"     Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial     Asthma Patients   "
117980|NCT01741675|"     ABSTRACT The purpose of the study is to investigate if a monetary incentive can increase the     response rate for vulnerable children and youth in a postal survey. A secondary purpose is to     test if monetary incentive has an effect on the content of answers in a postal survey. The     study is a randomized controlled trial where participants will be randomly allocated to     receive a questionnaire together with a €15 voucher for a supermarket or to only receive a     questionnaire. Data are taken from an intervention study aiming at creating network for     different groups of vulnerable children and youth aged 8-23 years. The questionnaire survey     in the present study is a follow up survey of the original study which are performed 1-2½     years after the participant have left the study. Recruitment to the original study is still     ongoing and the investigators expect the total participation to be around 250. In the primary     analysis the investigators will estimate the relative risk (RR) to assess whether there is a     difference between group allocation and questionnaire response rate. The investigators will     adjust for age in the analysis. In the secondary analyses the investigators will test whether     scores on the five SDQ scales are different between group allocations. The investigators will     adjust for the covariates age and gender, since the scores may depend on age and gender (4).   "
117981|NCT01741662|"     The objective of the LEA-PsyCog project is to assess the prevalence of psychiatric disorders     and psychocognitive impairments in adolescents surviving childhood leukemia .      The second objective is to explore the complex relationships between psycocognitive     development and soiciodemodemographics data, main characteristics of leukemia, treatments,     side-effects, quality of life and characteristics of proxyies environment.      3. Materials and Methods The LEA study is based on the constitution of a multi-centric     prospective cohort in 11 university hospitals: Bordeaux, Clermont-Ferrand, Grenoble, Lyon,     Paris (Trousseau, Robert Debré, St Louis), Marseille, Montpellier, Nancy, Nice, Rennes. Are     inclued in LEA all the children diagnosed and treated for acute leukemia since January 1980     (incident and prevalent cases), surviving at month 24 for the AML and ALL grafted in complete     remission and at month 48 for the ALL not grafted in first complete remission.      The LEA Psy-Cog study rests on a sample of the LEA cohort. Are included the patients     12-17-years-old from the PACA-Corse sub-cohort (administrative district of 4 million of     people which corresponds to the Marseille and Nice centers). Patients from this two centers     are the patients with the more important length of survey, allowing us to produce a not     biaised estimation of prevalence rate. Finally, the choice of this subsample is supported by     the proximity of the Mediterranean Center for Adolescent in Marseilles, specifically     dedicated to the psychological follow-up of children suffering from cancer.   "
117982|NCT01741649|"     Many solutions are used for cleaning the skin of a patient previous to a surgery. Although     the efficacy of clorhexidine has been proved in other surgical procedures, there is only a     retrospective study in cesarean section (they report no benefit of one solution over the     other). The investigators would like to evaluate the difference in surgical site infection in     patients after cesarean section comparing preparation of the skin with clorhexidine versus     povidone.   "
117983|NCT01741636|"     Survivorship Care Planning may improve overall well-being and quality of life of colorectal     and lung cancer survivors   "
117984|NCT01741623|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fasting condition in     normal, healthy, adult human subjects.   "
117985|NCT01741610|"     This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's     solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access     line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for     caesarean section.   "
117986|NCT01741597|"     This phase I trial studies the side effects of dynamic contrast enhanced magnetic resonance     imaging (DCE-MRI) in patients with advanced breast or pancreatic cancer with metastases to     the liver or lung. Diagnostic procedures, such as DCE-MRI, may help measure a patient's     response to treatment   "
117987|NCT01741584|"     The aim of the study is to investigate whether exercise improves cognitive and motor     functions in Parkinson's disease. To test this hypothesis, the researchers study general     brain functions in subjects with PD during a 6-months exercise program.   "
117988|NCT01741571|"     Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques     have not been well studied. The investigators will conduct a randomized study comparing the     diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.   "
117989|NCT01741558|"     Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce     the inflammatory profile in acute ischemic disease and reduce the area of ischemia.     Methotrexate is a drug that has shown promise in ischemic disease in animal studies.   "
117990|NCT01741545|"     The primary objective for this study is to evaluate the proportion of subjects who achieve     SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects     with Genotype(GT)-1b, -4 and GT-2, -3   "
117991|NCT01741532|"     A multi-center, placebo controlled, double-blind trial comparing the efficacy and safety of     18 months of treatment with deferiprone versus placebo in patients with PKAN.      This investigator-initiated trial is funded by the European Commission's Seventh Framework     Programme (FP7/2007-2013, HEALTH-F2-2011, grant agreement No. 277984) to the TIRCON     consortium (Treat Iron-Related Childhood-Onset Neurodegeneration) and by the FDA OOPD (Dr.     Elliott Vichinsky)   "
117992|NCT01741519|"     The study will compare the pharmacokinetics (PK), safety and tolerability of long-term     infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of     blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic     cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR) and     adverse events (AEs).   "
117993|NCT01741506|"     The purpose of the study is:      To estimate patients with lung cancers who will undergo surgery total haemostatic /     thrombotic capacity pre, per-and postoperatively.      To investigate whether prophylactic treatment with Low Molecular Weight Heparin (LMWH)     affects the patient's potential hypercoagulability.      To investigate whether there are differences in patients who will undergo Video Assisted     Thorascopic Surgery (VATS) or open surgery in regards of impact of the coagulation system.   "
117995|NCT01741480|"     The study will begin in 2013 whereby patients having an early warning system (EWS) alert will     be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT     is usually made up of a nurse and/or a physician who respond to a requested activation of the     RRT (called an ACT). The intervention will occur as follows:        1. Real-time monitoring of the eight general hospital wards (GHWs)((10100, 10200,          11100,11200, 12100, 12200, 14400, 14500)will occur 24 hours daily. Through multiple past          collaborative efforts and studies involving interventions at BJH, informatics personnel          have already demonstrated that they can accomplish this task using their computing and          algorithmic resources. The prediction tool (PT) employed is a validated PT aimed at          identifying any form of clinical deterioration occurring on a GHW requiring ICU transfer          or leading to patient death.        2. Patients meeting the prediction criteria for an increased risk of clinical deterioration          will be identified on the GHWs. An automated text message will be generated that          provides the patient's name, their room number, the date and time of the message, and          text indicating that they meet the criteria for risk of deterioration. Messages will          only be generated for patients assigned to the intervention group.        3. The EWS text message will be sent to the on-call RRT nurse's phone. These are phones          that are transferred from one RRT nurse to the other as changes of shift occur. It is          their primary means of communicating with the hospital.        4. The RRT nurse for the intervention patients will go into the flagged patient's room          within 10 to 15 minutes of receiving the message and perform a clinical assessment.          Based on the RRT nurse's assessment either no additional action need occur or he/she          will call either the physician on duty or activate an ACT as well as apply the four          D's, which was internally established at Barnes-Jewish Hospital (BJH) for treatment of          patients on GHWs identified to have impending clinical deterioration. The four D's          refer to the following: Discuss level of care, Drugs for treatment (e.g., antibiotics),          Diagnostics (lab tests, cultures), and Damage control (e.g., use of intravenous fluids,          oxygen).   "
117996|NCT01741467|"     This study will investigate whether real-time continuous glucose monitoring can be used as a     tool for behavior change in people with pre-diabetes.   "
117997|NCT01741454|"     The purpose of this study is to determine whether combination therapy with Tolterodine ER and     Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent     symptoms.      The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will     provided added benefits in reducing stent symptoms in patients who have had unilateral     placement of a ureteral stent.      The investigators hypothesize that combination therapy with tamsulosin and tolterodine ER     will yield greater symptom relief than tamsulosin alone.   "
117998|NCT01741441|"     After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux     symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability     to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR)     or weakly acidic reflux (WAR). To date, few studies have evaluated functional outcome after     LTF in patients with MR or WAR, with the majority reporting only short-term results.      It has been shown that delayed gastric emptying (DGE) might also be an important factor for     abdominal distension and adverse outcome after LTF.9,10 However, the correlation between poor     long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in     patients with MR or WAR is poorly investigated.   "
117999|NCT01741428|"     Early interventions to promote physical activity, dietary lifestyle changes and optimal     medication for cardiovascular risk factor reduction in over 3 years follow-up. A randomized     Clinical Trial.   "
118000|NCT01741415|"     Despite recent advances in substance abuse interventions, a large percentage of clients     entering residential treatment for substance use will drop out of treatment prematurely, and     of the remaining, many will relapse soon after treatment completion. Previous research     indicates that an individual's ability to withstand psychological distress is a key factor     necessary to maintain drug and alcohol abstinence and to remain in substance use treatment     without absconding. In previous work, Dr. Bornovalova developed a specific distress tolerance     treatment called Skills for Improving Distress Intolerance (SIDI). This intervention features     skills training in behavioral and acceptance strategies and intentional clinical exposure to     emotional distress. SIDI was developed and piloted with a sample of urban drug users seeking     treatment in a residential facility. Individuals receiving SIDI exhibited greater improvement     in distress tolerance than those in two comparison groups (receiving treatment-as-usual and     supportive counseling).      Current study. The investigators received NIDA funding to conduct a randomized clinical trial     with 325 clients entering a residential substance use treatment facility. Study participants     will be randomized into two treatment groups: (1) those receiving SIDI and (2) those     receiving Supportive Counseling (SC). Participants will receive 10 treatment sessions over a     period of 4 months. Then, the investigators will follow clients for one year to examine     treatment retention and abstinence.   "
118001|NCT01741402|"     The objective of this work was to compare the effects of two balance training programs, one     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,     on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. It     is a prospective, single blinded, randomized clinical trial performed at Center of Research     of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo     University. Thirty-two older adults are randomly in control and experimental group, 16 each     one. The study includes only participants scoring at least 24 in the Mini-Mental State     Examination to rule out effects of dementia; without the presence of depression, according to     the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg     Balance Scale (EBB ≥ 41).   "
118002|NCT01741389|"     The main aim is to examine the influence of daylight and melatonin on the temporal variations     of hemostatic factors with key roles in the hemostatic process and its regulation. Particular     emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with     tetraplegia with able-bodied control subjects.   "
118017|NCT01741194|"     This study will evaluate the effects of daily dosing of AC-1204 on cognition, activities of     daily living, resource utilization, quality of life, pharmacokinetic measures and safety     among participants with mild to moderate Alzheimer's Disease.   "
118003|NCT01741376|"     The purpose of this study is to examine the role of progesterone (a hormone found in both men     and women) on stopping cocaine use. The study will examine whether the medication, in     combination with behavior therapy will decrease cocaine use, cigarette smoking, withdrawal     symptoms, impulsivity and stress.   "
118004|NCT01741363|"     1. The abundant results from this trial will be helpful for assessing the feasibility of          increasing stool sampling and shortening screening interval in population setting for          lower and upper gastrointestinal tract lesions, their long-term effects, and the          respective cost-effectiveness.        2. The study will evaluate the value of population-based screen and treatment for H. pylori          infection when the HPSA is combined with the FIT.   "
118005|NCT01741350|"     To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention     designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by     comparing risk-behavior outcomes of four weekly intervention sessions with a     time-and-attention-matched control condition.   "
118007|NCT01741324|"     Vitamin D has a range of biological effects of public health relevance. Vitamin D status is     assessed on levels of its metabolite 25-hydroxyvitamin D [25(OH)D], where levels < 50 nmol/L     indicate insufficiency. Despite studies indicating that the vitamin D intake among Swedish     children are significantly below recommendations, little is known of their vitamin D status.     The investigators have recently found inadequate vitamin D status in pre-school children     living in northern Sweden, especially in dark-skinned children and during the winter months     despite vitamin D intakes meeting the recommendations. Overall, 25% of the light skinned and     40% of the dark skinned children had S-25(OH) D <50 nmol/L (Öhlund I, unpublished data). The     aim is to examine which amount of vitamin D is needed to maintain or increase S-25(OH)D to     ≥50 nmol/L among 97.5% of the participants regardless of skin color or geographic location     (northern or southern Sweden). Furthermore the investigators will examine if vitamin D status     affects on health markers as bone density, blood pressure, serum lipids, fatty acids,     inflammatory and immunological markers and mental wellbeing.      Children aged 5-8 years living either northern (Umeå) or southern Sweden (Malmö) will be     recruited to this trial during November-December 2012. They will be randomized to a vitamin D     supplement of either 10 or 25 g per day, or in Malmö also placebo to be used for three     months. The randomization will be stratified according to skin color (light or dark)     according to a method using visual inspection and interviews of parents/guardians. The     investigators will use a 2×2×2 factorial design to investigate the effects of two different     doses of vitamin D (10 µg and 25 µg) in children with dark and light skin color, living in     northern (Umeå) and southern (Malmö), Sweden. In order to achieve a moderate difference     between groups (effect size 0.25) 20 children per group are required (power> 87%, alpha =     0.05). With an estimated dropout of 10%, a total of 220 children will be included.      At baseline, the participants will undergo blood sampling for S-25(OH)D and other biomarkers,     blood pressure and anthropometrical measurements, including bone densitometry and body     composition using air displacement pletysmography, and the parents will answer a     questionnaire on behavioral and emotional problems in the participating child using the Child     Behavior Checklist. These measurements will be repeated at follow-up in February-March 2013.   "
118008|NCT01741311|"     This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original     HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART     (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness trial     among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or     sexual risk behavior.   "
118009|NCT01741298|"     The metabolic syndrome is increasingly being recognized as a major threat to good health -     especially cardiovascular health - and its frequency appears to be increasing in relation to     the current epidemic of obesity. The objective of this study is to determine whether a     program of enhanced lifestyle intervention can, compared to standard care, reduce the     frequency and severity of the metabolic syndrome as assessed by clinical, metabolic,     inflammatory and vascular outcome measures. EC will consist of a 17-session structured,     lifestyle intervention plan, directed at achieving weight reduction and increasing physical     activity change through education, behavior modification and stress management, and conducted     in groups. It will comprise a 3-month Core Curriculum of 8 sessions, followed by a     Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in     breaking through barriers in working with socioeconomically disadvantaged members of minority     groups. All participants will have baseline, 6-monthly and 1-year assessments. This project,     Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome     (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may     contribute to the progression or amelioration of atherosclerotic processes underlying the     pathogenesis of coronary heart disease (CHD).   "
118010|NCT01741285|"     We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in improving     small airways dysfunction, especially in ex-smokers and smokers with asthma.      To investigate this, we will perform a study comparing the efficacy of extra-fine particle     HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone     (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in     ex-smokers and smokers with asthma.      Study design: This study will be an open-label, randomised, three-way cross-over, two-center     study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for two     weeks:   "
118011|NCT01741272|"     The primary objective of this study is to determine if early active range of motion after     mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6     weeks and 3 months after surgery. The secondary objective of this study is to determine if     early mobilization improves disease-specific quality of life and promotes earlier return to     work/function.      Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of     range of motion, improved disease specific quality of life and earlier return to     work/function if allowed to begin early active range of motion compared to subjects who are     immobilized in a sling for 6 weeks.   "
118012|NCT01741259|"     The purpose of this study is to determine if epidural meperidine administered by     patient-controlled bolus button is equivalent to a low dose infusion plus patient-controlled     bolus.   "
118013|NCT01741246|"     Investigators hypothesize that chronic primary headaches are accompanied by a discrete     pattern of brain metabolism and activity involving brain structures related to the     development of acute exacerbations as well as pain modulation. Such structures include the     brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain     imaging.   "
118014|NCT01741233|"     The overall purpose of the study is to investigate whether there is a relationship between 26     different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B     (UV-B) irradiation of the skin and vitamin D status.      The hypothesis is that vitamin D status are influated by different genetic genotypes in the     vitamin D pathway.   "
118015|NCT01741220|"     The aim of this study is to identify factors influencing work engagement and wellbeing in     German-speaking intensive-care providers and anesthesiologists.   "
118065|NCT01740570|"     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     cabazitaxel that can be given to patients with glioblastoma. The goal of Part 2 is to learn     if cabazitaxel can help to control glioblastoma. The safety of the study drug will also be     studied in both parts.      Cabazitaxel is designed to interfere with the growth of cancer cells by stopping cell     division.   "
118650|NCT01733108|"     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)     affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how     the drug affects the body) of a single dose of glyburide.   "
118018|NCT01741181|"     Background and Objectives :      The presence of vitamin D deficiency in patients with type 2 diabetes mellitus (T2DM) is     associated with an increased risk of cardiovascular disease (CVD). We aim to see whether     supplementation of vitamin D in these patients helps to improve the endothelial function (EF)     a surrogate marker of CVD risk.      Hypothesis: Vitamin D supplementation in patients with T2DM and low serum 25(OH) D     concentrations (<30ng/ml) will improve EF as measured by the Endo-PAT machine by 0.4 units     (30% improvement over baseline) and/or will result in a increase of EPCs (CD133+/KDR+) and     CD45dim CD34+/KDR.      The investigators will test this hypothesis by comparing 2 groups of T2DM patients randomized     to placebo or vitamin D3 for 16 weeks.      Methods:      This is a 16 weeks trial in which 120 T2DM patients will be screened with the aim to recruit     60 T2DM patients with vitamin D deficiency or insufficiency. Out of these 60 patients , 30     patients will be started on vitamin D supplementation and 30 patients will be given a matched     placebo. Endothelial function (EF) will be checked before and after supplementation to see a     change in EF.      Significance of Project:      If this study shows a significant improvement of EF, it would justify larger scale studies to     show that vitamin D supplementation in patients with T2DM mitigates CVD risk and vitamin D     supplementation in patients with T2DM and vitamin D deficiency to improve CVD risk.   "
118019|NCT01741168|"     Braces have been used o treat stable (not requiring surgery) burst fractures with much     success. Recently questions have been raised in regards to the importance of the brace. Some     studies have results that suggest a brace is not important in having a good outcome. However,     this has never been proven. This study is being conducted to see whether or not wearing a     brace is important to having a good outcome.   "
118020|NCT01741155|"     The purpose of this study is to estimate and compare the objective response rate of SPI-1620     administered in combination with docetaxel in patients with NSCLC and to determine the safety     of SPI-1620 when administered in combination with docetaxel.   "
118021|NCT01741142|"     The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.   "
118022|NCT01741129|"     The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation     (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant     treatment in preterm infants.   "
118023|NCT01741116|"     The aim of this study is to evaluate efficacy and safety of Dovitinib(TKI258) in patients     with castration resistant prostate cancer after failure of docetaxel-based chemotherapy.     Further correlative study for metabolic response using PET image and change in serum     fibroblast growth factor 23(FGF23) will be conducted.   "
118024|NCT01741103|"     The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose     concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal     glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood     glucose concentrations) and indices of oxidation stress in the plasma of these subjects.   "
118025|NCT01741090|"     Background & Aim: Bone marrow derived mesenchymal stem cells (BM-MSCs) have capacity to     differentiate into hepatocytes and anti-fibrotic effect in the experimental model. No study     was done in humans with alcoholic liver cirrhosis. The researchers investigated the     anti-fibrotic effect of BM-MSCs in alcoholic cirrhosis as Phase II clinical study.      Methods: Eleven alcoholic cirrhosis patients (M:F = 10:1) with Child-Pugh's class B and     maintenance of alcohol abstinence at least 2 months were enrolled. At baseline, all patients     received liver biopsy, hepatic venous pressure gradient (HVPG) measurement and serologic     tests. BM-MSCs were isolated from each patient's BM and amplified for one month and injected     two times at 4, 8week through Rt. hepatic artery. 5x106cells/mL of BM-MSCs were injected in     each session. Follow up biopsy, HVPG and relative expression of tissue transforming growth     factor-1 (TGF-β1), α smooth muscle actin (α-SMA) and collagen-1 by real time RT PCR were     measured after 12weeks from 2nd BM-MSC injection. The primary outcome was improvement in     patients' histology Aim :      The researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow     derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver     cirrhosis.   "
118026|NCT01741077|"     The purpose of this cross-sectional study was to examine whether or not physical changes or     adaptations occur in response pregnancy or to the higher intakes of folic acid from     supplementation typically consumed during the reproductive period.   "
118027|NCT01741064|"     The purpose of the study is to evaluate the long term vascular morbidity and mortality in     kidney transplant recipients based on one year post transplant levels of intact parathyroid     hormone.   "
118028|NCT01741051|"     The purpose of this study is to use an air filter intervention to evaluate the relationship     between particulate matter air pollution exposure during pregnancy and fetal growth. We     hypothesize that: 1) portable high efficiency air (HEPA) filters will produce major     reductions in home indoor concentrations of particulate matter and 2) pregnant women whose     exposures to particulate matter are reduced by this intervention will give birth to children     with greater mean body weight for gestational age.   "
118029|NCT01741038|"     This is a personalized anti-cancer vaccine protocol which includes an in-situ (in the body)     cancer vaccine step which combines killing a single metastatic tumor lesion by use of     cryoablation in order to cause the release of tumor-specific markers to the immune system and     then injecting bioengineered allogeneic immune cells (AlloStim) into the lesion as an     adjuvant in order to modulate the immune response and educate the immune system to kill other     tumor cells where ever they reside in the body.   "
118030|NCT01741025|"     The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint     pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative     management of the SI joint   "
118031|NCT01741012|"     Cervical neoplasia is increased in women with SLE most likely due to cervical infection with     human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18.     Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients     (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can     prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies     have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil     vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with     mild to moderate and minimally active or inactive SLE and measure how well they make     protective antibodies after receiving the vaccine. In other words this will check how well     the vaccine works in SLE.   "
118034|NCT01740973|"     Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain,     especially around the umbilical port is dominating the first postoperative week. Single     Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative     incisional pain and improve cosmetic results, but results are not convincing and the risk of     formation of an umbilical trocar-site hernia is not properly investigated.      This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC     vs. conventional 4-port laparoscopic cholesystectomy.      Methods This is a cohort registry study with prospective questionnaire and clinical follow-up     on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a     conventional laparoscopic cholecystectomy (consecutively from one month before and after     SILC. They are matched for age, gender, date of operation, and surgeons skills (database from     intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation     (operation for a umbilical hernia or clinical hernia).      The H0 hypothesis is that there is not difference between SILC and conventional.      Exclusion criteria are: death, operation for acute cholecystitis. The included patients will     be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia,     and perioperative data that we do not have in the database. Futhermore those patients who     suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis.     Furthermore we patients are asked to report if they have chronic pain and/or discomfort.   "
118035|NCT01740960|"     The results of phase I Namisol® study (Klumpers et al. Br J Clin Pharmacol, 2012), implicate     that Namisol® may have a favorable PK and PD characteristics and is safe to use in people.     However, the study included only young adults with a mean age of 21.4 years. In a previous     THC study, subjects age has been associated with treatment response and tolerance of adverse     reactions. This association was not supported by Lane et al. and Volicer et al.      There is concern about the safety and tolerability of THC in the elderly population. This is     because, elderly persons in general have higher risk of adverse drug reactions due to a     combination of physiological factors such as decreasing in lean body mass, the reduction of     renal and hepatic clearance, and medical comorbidity which can lead to polypharmacy and     drug-drug interactions. Therefore, data from the phase I trial cannot be translated directly     to an elderly (and likely more vulnerable) population. This makes it important to evaluate     the safety and tolerability profiles of different Namisol® doses in the elderly. In our study     in progress Delta-THC in Behavioral Disturbances in Dementia, the Namisol® doses of 0,75 mg     and 1,5 mg are, until now, well tolerated by elderly subjects. These doses are, however, very     low in comparison with the doses used in phase I study with young adults (5 mg, 6,5 mg and 8     mg). The current study on the safety and tolerability of relatively high doses of Namisol®     will help us in the future to provide broad advice on the therapeutic index and safety     profile of Namisol® in the elderly population.   "
118036|NCT01740947|"     The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD     can reduce clinical anastomotic leakage rate and its septic consequences as well as other     infectious complications. By reduction of septic complications long-term oncological outcome     might simultaneously improve.   "
118037|NCT01740934|"     This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled,     parallel-group study followed by an eight-week open-label extension to evaluate the safety,     tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to     evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild     to moderate rosacea.   "
118038|NCT01740921|"     Some gut hormones, called incretins, stimulate insulin production in order to control sugar     levels but also activate brain centres and signal to stop eating. Current administration of     incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the     skin) injection and has been routinely available for diabetic patients for more than 4 years.     It is an effective treatment for the lowering of blood glucose with an average weight loss of     about 3-4kg.Recent evidence, from animal studies and limited human studies, suggests that     incretins based treatments may also have beneficial effects on blood vessel function.     However, it is not known whether this effect is by direct action on the blood vessel     independent of an improvement of latent inflammation which is typically associated with     weight loss or an anti-inflammatory effect of the incretin treatment itself. The aim of this     study is to determine whether the incretin-based diabetes treatment with the GLP-1     (Glucagon-like peptide 1) analogue Liraglutide (also known as Victoza), which mimics the     actions of incretins, improves blood vessel function in individuals with type 2 diabetes. It     will determine whether the improvement in blood vessel function is independent of the effect     of weight loss and changes in inflammation. This by the study of vascular function before and     after 4 months of Victoza treatment in subjects with Type 2 diabetes in comparison with 1)     participants randomized to hypo-caloric diet to achieve a similar weight loss than with     Victoza and 2) participants randomized to treatment with once daily aspirin. Comprehensive     assessment of blood vessel function, body fat distribution and metabolic profile at baseline     and at the end of the treatment phase will be combined with assessments of inflammation     markers in blood and in fat tissue biopsies.   "
118039|NCT01740908|"     This is an observational research study whose purposes are to see the effects of repeated     hyperbaric oxygen therapy treatments on the levels of stem/progenitor cells in peripheral     circulating blood following five days of treatment, 90 minutes per day at 2.0 atmospheres     absolute in 100% USP Grade Oxygen. Hyperbaric oxygen has a greater oxygen concentration than     air at sea level. In this research, the concentration of oxygen will be twice the level of     oxygen at sea level.   "
118066|NCT01740557|"     The goal of this clinical research study is to learn the side effects of T-cells injected     with CXCR2 and NGFR when given in combination with chemotherapy (cyclophosphamide and     fludarabine) and aldesleukin to patients with metastatic melanoma in an attempt to allow them     to better localize the tumor. The safety of this combination will also be studied.   "
119897|NCT01716559|"     This observational, prospective, multicenter study will evaluate the treatment response rate     and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy.     In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be     collected for 16 weeks.   "
118041|NCT01740882|"     Laparoscopic incisional hernia repair a variety of fixation methods has been proposed to     ensure the correct and stable intra-abdominal placement of the mesh, in order to prevent     recurrence, but on the other hand avoiding long-term pain and discomfort. The optimal method     is unclear.      In Denmark the investigators have a nationwide database that records 80% of all ventral     hernia repairs. The investigators combine data from the Danish Hernia Database, the National     Patient Registry, and prospective questionnaire and clinical follow-up in order to get the     true recurrence rate (clinical and reoperation rate) and the degree of long-term discomfort.      Purpose The purpose of this national prospective kohort study is to compare the risk of     developing recurrence of incisional hernia after laparoscopic incisional hernia repair with     either absorbable or non-absorbable tacks, and to investigate possible. late complaints in     terms of pain and discomfort after the two mesh fixation devices.      The investigators include 355 laparoscopic incisional hernia repairs with absorbable tacks     and 726 with non-absorbable tacks. It is expected that about 300 patients will be offered     physical examination.      Material and Method Register-based cohort study of perioperative entry of patient data and     prospective questionnaire follow-up and depending on the answer to any. clinical trial.      Follow-up is done by searching the Danish Hernia Database and the National Patient Register     (to ensure data completeness) and distribution of patient questionnaire as reoperation for     hernia recurrence is an underestimate of the true recurrence risk.      Statistics There will be performed frequency analyzes and Kaplan Meyer statistics on the 2     groups supplemented with multivariate Cox regression analysis. Using non-parametric     statistics. P <0.05 considered statistically significant.   "
118042|NCT01740869|"     The purpose of this study is to determine whether the plasticity of autologous intrathecal     hematopoietic cells would improve the neurologic and the social skills of pediatric patients     with autism spectrum disorders.   "
118043|NCT01740856|"     Reducing the rest time after diagnostic cardiac catheterization for three hours does not     increase the complications concerning to the procedure, compared to the rest of five hours.   "
118044|NCT01740843|"     In this study the effect of tDCS intensity on motor performance and corticospinal (CS)     excitability is evaluated. The investigators expect that a positive relationship between     current intensity and motor performance/CS excitability.   "
118045|NCT01740830|"     The current study investigates the effects of tDCS in patients with multiple sclerosis (MS).     The investigators hypothesize that anodal tDCS will increase motor performance in patients     with MS.   "
118046|NCT01740817|"     The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like     receptor 4 (TLR4) signaling in human subjects   "
118047|NCT01740804|"     Primary endpoint To observe the dynamic changes of CTC during the process of platinum based     chemotherapy in advanced NSCLC.      To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and     PFS).      Secondary endpoint To study the relationship between CTC and overall survival. To study the     molecular feature of CTC, such as epidermal growth factor receptor (EGFR), KRAS, CD117, etc.   "
118048|NCT01740791|"     The goal of this study is to assess the safety, tolerability, antiviral activity and     pharmacokinetics of GS-5816 in HCV treatment naïve subjects with genotypes 1-6.   "
118049|NCT01740778|"     To evaluate pain responses using the Aurora lancing device and Velvet 33g lancet compared to     other common, commercially available lancing systems. Subjects will test the devices at a     depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini     blood glucose meter using OneTouch® Ultra® blood glucose test strips from either the     fingertip or alternate site testing.   "
118050|NCT01740765|"     This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on     energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition     Research Institute (UNC NRI).   "
118051|NCT01740752|"     Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment     research study between the University of North Carolina (UNC) Eating Disorders Program and     the UNC Department of Psychology and is funded by the National Institute of Mental Health.     The study examines two comprehensive treatments as couples face the challenges of anorexia     nervosa (AN). The program helps patients with AN and their partners address AN symptoms and     unique stresses that AN places on the romantic relationship.   "
118052|NCT01740739|"     The objective of this study is to explore the relationship between the ClearView scan results     and a variety of cardiovascular risk indicators such as the Coronary Calcium Score,     Framingham Risk Factors, Reynolds Risk Score, and biomarkers of inflammation. The ClearView     device is a bio-electrographic tool that may assist medical professionals in rapid assessment     of the systemic origin of the patient's presenting symptom(s). The ClearView is a potentially     valuable resource that may benefit a physician's office by offering expedited differentiation     capabilities. The subsequent results have the potential to include more data that would allow     rapid patient diagnosis, triage, and treatment; optimized precious resource expenditure     (nursing, physician, etc.); lower costs to facility, patient and insurance company; and     decreased office wait time.   "
118053|NCT01740726|"     This study focuses on treating adolescents with depression. The study has two main purposes.     The first is to compare a new form of therapy for depression called Behavioral Activation     (BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more     involved in activities they find enjoyable, which can reduce symptoms of depression. Research     shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However,     unlike previous research, this study examines how well the two treatment options work in     comparison to each other. Participants in the study are randomized to receive treatment with     either BA or fluoxetine for 18 weeks.      The second aim of the study is to examine the brain functions of adolescents in both     treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans     before and after treatment. The data from these scans will be used to compare the brains of     participants in the BA condition with those in the fluoxetine condition. Also, the scans may     show possible differences between participants' brains before and after treatment. These data     may help scientists determine the ideal form of depression treatment for different types of     people.   "
142120|NCT01424228|"     The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride     versus placebo in subjects aged 18 years and older with chronic constipation.   "
118067|NCT01740544|"     Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex     (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well     as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann &     Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to     poorer test performance.   "
118068|NCT01740531|"     To evaluate the efficacy and safety of S 303 treated red blood cells (RBCs) in subjects who     require chronic transfusion support due to thalassemia major.   "
118069|NCT01740518|"     The purpose of this study is to compare two regimens of low volume (2L) polyethylene     glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in     out-patients   "
118054|NCT01740713|"     Deferiprone (DFP) is the most extensively studied oral iron chelator to date. It has been     authorised in Europe in 1999 for the treatment of iron overload in patients with     beta-thalassaemia major when DFO is contraindicated or inadequate. Despite a wide experience     of DFP there are limited experimental data available on DFP in children and no     pharmacokinetic data in children under 6 years of age. On the basis of the existing data in     adults and adolescent, in the DEEP-1 trial a pharmacokinetic bridging model was developed to     support the dose selection in children aged less than 6 years affected by transfusion     dependent haemoglobinopathies. The study consisted of two phases, namely an experimental     phase, during which patients received a single dose and a modeling phase, during which PK     data obtained after single dose in patients < 6 years of age were analysed in conjunction     with historical PK data in adults and older children and adolescents. The model-based     analysis of the data obtained after single dose enabled the assessment of the dosing regimen     required for the purpose of accurate pharmacokinetic bridging. The ratio between the     predicted systemic exposure parameters (AUC and Cmax) in the target population and reference     group were used as basis for recommendation of the dose in the target population.   "
118055|NCT01740700|"     The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical     experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the     treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).   "
118056|NCT01740687|"     The purpose of the post approval study is to evaluate the effectiveness and safety of the     Essure System when a NovaSure Endometrial Ablation procedure is performed following a     successful Essure Confirmation Test.   "
118057|NCT01740674|"     One of the biggest challenges of conducting research where the investigators follow people     over a long period of time is keeping the participants involved. One of way that     investigators may be able to improve participant involvement in research is to give     participants the opportunity to complete their questionnaires online.      Here's how the investigators think the Internet data collection system will help to keep     participants involved and ultimately help to answer important questions about the effects of     nutrition during pregnancy:        1. It will allow investigators to present complicated questionnaires in a way that doesn't          confuse participants. For example, instead of telling participants to skip the remainder          of a question if they answered no to the first part of the question, the ePRO system          does the skipping for them. The result is less confusion, fewer questions to read, and          less of the participant's time.        2. It provides a convenient way for participants to keep track of where to find the          questionnaire, and how much they have already completed. Participants sometimes don't          have time to answer all of the investigator's questions in one sitting. The ePRO system          keeps track of how much participants have already done and it's ready to keep going          whenever the participant has time. It also avoids the common problem of losing the          questionnaires to the household paperwork pile, or worse to the recycling bin.        3. It provides timely reminders to participants. Study participants, and especially new          moms, are busy and they forget to complete the questionnaires. The ePRO system can          provide timely reminders encouraging participants to respond.        4. It helps participants complete the questionnaires accurately. The ePRO system has an          automatic error detection ability that will alert participants to any questions they          missed or completed incorrectly.      Finding ways to keep participants involved in research is something that all researchers are     concerned about, and ultimately it's a concern for all Canadians because the results of     research are often used to make decisions about health care and the kinds of programs that     governments provide. Losing any participant from the study reduces the ability of policy     makers to take the best decisions and choices about what health services to fund with limited     dollars. What the investigators propose is a study to determine whether Internet data entry     really will keep participants involved in a longitudinal study. Previous studies have shown     that the internet can be a useful tool for getting people to sign up for research and at     least one small study showed that using Internet data entry can actually save money. But no     researchers have actually tested whether it really does a better job than paper based     questionnaires in terms of keeping participants involved.      In order to answer this question, the investigators will randomly assign the current Alberta     Pregnancy Outcomes and Nutrition study participants to either continue receiving the     paper-based questionnaire or to start receiving the web-based surveys. The investigators will     follow participants over three assessment occasions (over a period of 18 months) and observe     any differences between the groups in their involvement. Because the investigators are     randomly assigning participants to the two groups, differences in involvement will tell them     about usefulness of Internet data entry as a participant retention tool.   "
118058|NCT01740661|"     The purpose of this study is to determine the immediate effects of cryotherapy on the lower     extremity biomechanics during running.   "
118059|NCT01740648|"     This phase I trial studies the side effects and best dose of trametinib when given together     with fluorouracil and radiation therapy before surgery in treating patients with stage II-III     rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving trametinib     together with fluorouracil and radiation therapy before surgery may make the tumor smaller     and reduce the amount of normal tissue that needs to be removed   "
118060|NCT01740635|"     Many older adults have difficulty walking. A wheelchair can improve their participation but     older adults typically receive little wheelchair training. Structured training programs are     effective but rely on multiple 1:1 sessions with a skilled clinician. EPIC WheelS combines 2     brief training sessions and a 4-week home training program delivered using a portable     computer tablet and monitored by an expert trainer. This study investigates the feasibility     and potential for using EPIC WheelS with older adult novice wheelchair users in Vancouver and     Winnipeg, measuring the impact on wheelchair skill, safety and confidence compared to a     control group receiving only cognitive training.      Hypotheses: The investigators expect that the feasibility outcomes will be sufficiently     robust to support conducting a subsequent multi-site RCT. The investigators also expect the     EPIC WheelS training program will have a significant treatment effect with improvement in     wheelchair mobility, compared to a control group.   "
118061|NCT01740622|"     Aim      To evaluate the efficacy of a CCHMC Human Resources Benefits program to reduce exposure to     injury hazards and subsequent injury-related medical claims for their children.      Hypothesis      H1: The investigators anticipate, based on our recently completed trial, that the     installation of multiple, passive safety devices in the homes of children 6- to 36-month old     children of CCHMC non-contract employees randomized to the intervention group will reduce     childhood injuries and medical claims by 50% compared to children of CCHMC non-contract     employees who do not receive the home safety program.      H2: Cincinnati Children's Hospital Medical Center Employees whose children are randomized to     the intervention will have 30% less lost work days compared to employees whose children are     assigned control group.   "
118063|NCT01740596|"     Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the     safety and efficacy of the C-Pulse® System (C-Pulse).      The purpose of the study is to determine whether the use of the C-Pulse as a treatment for     patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such     that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the     device in the United States.   "
118064|NCT01740583|"     The purpose of this study is to test the safety and device performance of the Mitralign     system (MPAS) to treat functional mitral valve regurgitation.   "
118071|NCT01740492|"     This study aims to address both the management and evaluation of pain. The primary aim of     this study is to determine the efficacy of low dose ketamine in adults with moderate to     severe pain in the emergency department as compared with parenteral opioids alone. Another     aim is to examine the safety of low dose ketamine compared to opioids alone.      The investigators hypothesize that low dose ketamine will result in more effective pain     control than morphine alone and will not be associated with an increase in adverse events.   "
118072|NCT01740479|"     To determine whether, on a background of optimal medical therapy, including ticagrelor,     opening of all suitable narrowings or blockages found at the time of primary PCI for an acute     heart attack is better than treating only the culprit lesion in patients with multi-vessel     disease.   "
118073|NCT01740466|"     Epidemiological study about eye discomfort complaints, comorbidities and diagnosis at a     Brazil`s ophthalmological public care service   "
118074|NCT01740453|"     Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic     dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h).     The investigators hypothesized that continuous interscalene block would prolonged ventilatory     impairment   "
118075|NCT01740440|"     Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)   "
118076|NCT01740427|"     The study is designed to compare the clinical benefit following treatment with letrozole in     combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal     women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti     cancer therapies for their advanced/metastatic disease.   "
118077|NCT01740414|"     Opioid drugs increase glial cell activation which may be related to the abuse liability of     opioid drugs. Data supporting this hypothesis have demonstrated that glial cell attenuators     decrease the positive rewarding aspect of opioids in laboratory animals. Ibudilast (MN-166,     formerly AV411) is a compound that inhibits the activation of glia. Recent preclinical     studies demonstrate that while ibudilast increases the analgesic effects of opioids, it     decreases the rewarding effects of such drugs. It has also been shown that ibudilast     suppresses morphine-induced release of dopamine, a primary neurotransmitter involved in the     rewarding and reinforcing effects of abused drugs. Additionally, we recently found that     ibudilast decreases subjective symptoms of opioid withdrawal in opioid dependent humans     during detoxification.      Therefore, the primary aim of this 6-7 week inpatient study is to investigate the ability of     MN-166 to dose-dependently alter the reinforcing, analgesic, subjective, performance, and     physiological effects of oxycodone, a commonly abused prescription opioid.      This study includes a 10-day morphine taper phase, followed by two study phases     (approximately 18 days each) with daily active ibudilast and placebo administration,     respectively. After the detoxification phase, participants are randomized to receive placebo     or MN-166, and then be stabilized on the medication. Thereafter, participants will complete     laboratory sessions. Subsequently, during Phase 2, participants will cross over to the other     treatment arm, stabilize, and complete laboratory sessions.   "
118078|NCT01740401|"     The purpose of this study is to see whether the combination of low-dose Cyclophosphamide and     Anti-CTLA4 (Ipilimumab) will stop tumor growth in patients with advanced skin cancer. The     investigators expect to see an increase in response rate of the combination over Anti-CTLA-4     alone and estimate a response rate of approximately 20 % in the proposed population.   "
118079|NCT01740388|"     To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6%     (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial     conjunctivitis.   "
118080|NCT01740375|"     To investigate the role of esophagectomy in complete responders to preoperative     chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to     either observation or esophagectomy after concurrent chemoradiotherapy.   "
118081|NCT01740362|"     A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or     severe renal impairment, who do not require hemodialysis, compared to healthy controls.   "
118082|NCT01740349|"     This prospective pilot study of 30 pediatric subjects, that are indicated for standard     colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System     and the PillCam Colon Capsule in comparison to standard colonoscopy.      This study aims        1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with          standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.        2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.   "
118083|NCT01740336|"     This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate     the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in     participants with locally recurrent or metastatic breast cancer.   "
118084|NCT01740323|"     The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding     and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer     after having completed chemotherapy. Patients who have received prior chemotherapy will be     eligible, because we have found that this enriched population is at particular risk for     exhibiting increased NF-kB DNA binding and IL-6 following XRT.   "
118085|NCT01740310|"     The purpose of study will be to test two vaccine education strategies to learn how they     impact flu and pertussis (Tdap) vaccination rates and attitudes regarding vaccination during     pregnancy after participating in the intervention. The education strategies will be based on     the elaboration likelihood model (ELM). This model is based on experimental psychology and     has been previously used to increase breast cancer screening rates. These education     strategies will be delivered through routine prenatal care visits to black/African-American     women in Atlanta.   "
118086|NCT01740297|"     Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination     with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of     talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone. Talimogene     laherparepvec will be administered by intratumor injection, and ipilimumab will be     administered by intravenous infusion for a total of 4 infusions. Subjects will be treated     with talimogene laherparepvec until complete response, all injectable tumors have     disappeared, disease progression per a modified Immune-Related Response Criteria (irRC), or     intolerance of study treatment.   "
118087|NCT01740284|"     Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment     related adverse events when initiating treatment.      The majority are local allergic reactions within the mouth and/or throat, and most of these     reactions are mild or moderate. It is anticipated that intake of antihistamine before     initiation of Grazax treatment would most likely reduce the discomfort associated with     initiation of Grazax treatment. So this trial was to investigate if administration of     antihistamine prior to initiation of Grazax treatment results in a reduction of subjects     reporting local allergic reactions.   "
118088|NCT01740271|"     Epirubicin is a common chemotherapy medication used in the treatment of breast cancer.     However, chemotherapy dosing is calculated based on people's height and weight, which may not     be the most accurate way. The purpose of this study is to see if epirubicin dosing based on     people's genetic profiles is better than the usual methods.   "
118089|NCT01740258|"     Studies which have separately studied bevacizumab for recurrent gliomas and bevacizumab for     newly-diagnosed glioma have shown good results and the regimens have been well-tolerated by     patients. This study seeks to investigate the use of bevacizumab with the standard therapy     (radiation therapy and temozolomide) in newly diagnosed patients, followed by bevacizumab and     temozolomide with the continuation of bevacizumab following progression. Two critical     questions remain- the role of bevacizumab maintenance and bevacizumab at the time of     progression in a patient previously treated with bevacizumab at the time of initial     diagnosis.   "
118090|NCT01740245|"     Treatments for the macroscopic or pathologic lesions caused by HPV infection can be     classified as topical, surgical, destructive, or immunomodulatory. Post surgical treatments     generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce     the risk of local infections.      The aim of this study is to compare the efficacy and safety of polyhexamethylene     biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the post     recovery regimen after surgical treatment of cervical lesions.      Women who underwent to CO2 laser therapy for cervical lesions are randomly assigned to     receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories,     or polyhexamethylene biguanide vaginal suppositories (Monogin® / BiguanelleTM vaginal     suppositories, Lo.Li.Pharma, Italy). A weekly follow-up check was performed for 6 weeks.   "
118091|NCT01740232|"     Meniscus does not always heal when sutured. The investigators will make small holes in the     meniscus before repair to promote more bleeding. The investigators expect that will help the     meniscus to heal better.   "
118092|NCT01740219|"     This research study aims to develop an organizational-level intervention to enable     communities to adopt, adapt, implement and sustain evidence-based interventions (EBIs) to     address cancer disparities among Latinos. The investigators partner with faith-based     organizations, since they play a highly prominent role in Latino community life. This     three-phase study will: (1) improve understanding of the organizational infrastructure,     skills and resources required by Latino churches to implement EBIs for cancer control, (2)     develop a capacity-building intervention; and (3) test the intervention's effectiveness in a     randomized trial.   "
118093|NCT01740206|"     Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity     disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be     randomized to one of two groups: stimulant medication administered on the day of surgery or     stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology     will be at the discretion of the attending anesthesiologist, but the endpoint will be a     bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia.     Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and     the incidence of hypotension, bradycardia, or administration of medications will be compared     between the two groups.   "
118094|NCT01740193|"     The purpose of this research study is to find the best way to decrease pain in children right     after surgery whom have had their hernia fixed. Right now, there are two different ways     surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better     than the other. The method used is often chosen by which one the doctor has more experience     using. The Investigator plans to find out if one of the methods is more effective and/or     safer than the other method.      The results of this study will help learn how to best control pain in children having surgery     for hernia repair.   "
118095|NCT01740180|"     The primary objective of this study is to collect information about how CLIPPERS patients are     currently being treated in France.   "
118096|NCT01740167|"     1. The positive outcomes reported by participants in experimental group after two weeks of          interventions will be significantly better than before interventions.        2. The positive outcomes reported by participants in experimental group will be          significantly better than those in control group after two weeks of providing prevention          model interventions.        3. The positive outcomes reported by participants in experimental group will be          significantly better than those in control group after six months of providing          prevention model interventions.   "
118097|NCT01740154|"     The purpose of this research study is to determine how sunitinib (sunitinib malate) causes     fatigue. Patients will be asked to complete a brief questionnaire (survey) to rate their     levels of fatigue every two weeks while they are participating in this research study. The     questionnaire takes approximately 10-15 minutes to complete and is 9 questions. A series of     physical measurements for fatigue will be performed before the first dose of sunitinib and     again (4) weeks later to see if there are any changes in physical level of fatigues   "
118136|NCT01739647|"     This is a single dose study in healthy male and female (of non-child bearing potential)     volunteers, to assess the safety, effects on the body, and blood and urine drug levels of     AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease   "
118098|NCT01740141|"     The aim of the study is to find out if the timing of brachial plexus block, before or after     surgery, has an impact of the extent of acute postoperative surgical pain or the incidence     and severity of long-lasting (chronic) pain after surgery.      This is a prospective, randomized, double blind study in patients with radial fractures     undergoing surgery with volar plate. The patients will be followed up for 6 months after     surgery.   "
118276|NCT01737814|"     The purpose of this study is to evaluate whether MST-188 can reduce the duration of     vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also     evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a     recurrence of VOC. Additionally, this study will compare the development of acute chest     syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.   "
118099|NCT01740128|"     Many people with spinal cord injury (SCI) retain at least some movement below their injury,     but their muscles often have a 'mind of their own'. Typical exercise programs focus on     keeping muscles strong and flexible, but don't usually focus on helping patients control     their muscles. The investigators' exercise research study will compare two different programs     with the specific goal of improving conscious control of patients' muscles below the injury.     This study focuses on those with 'chronic' SCI - the injury occurred at least one year prior     to enrolling.      This is a single center study taking place in the Bronx, NY.      The first phase of the study will be observational - the investigators will analyze which     nerve connections might remain partially intact through the injury (even if the nerves aren't     consciously controlled). Participants with all severity of SCI may participate in this first     phase.      The second phase of the study will involve people who retain at least slight ability to move     their legs and the ability to move the arms against gravity. Each person will undergo two     different exercise rehabilitation strategies: weight-supported treadmill training; and     balance training combined with skilled arm or hand exercises.      The investigators will compare the effects of these exercise programs on a variety of     outcomes, including gait speed, balance, strength, and muscle activation in response to brain     stimulation.      The investigators hypothesize that participants with chronic SCI undergoing combined     balance/arm/hand training will show improved outcomes when compared to traditional gait or     balance training.   "
118100|NCT01740115|"     The purpose of this study is to expand and continue a cohort of HIV-infected adults to     establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current     substance dependence or ever injection drug use that have a spectrum of alcohol use; and to     determine the effect of alcohol consumption on changes in bone health prospectively in the     Cohort.   "
118101|NCT01740102|"     Objectives: Despite utilization of available means for cardioprotection during cardiac     surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore     necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method.     Laboratory research has shown promising results regarding myocardial survival during open     heart surgery, but the clinical value of RIPC is still largely unknown. The investigators     hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of     postoperative atrial fibrillation (POAF).   "
118102|NCT01740089|"     The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0     μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin     in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.   "
118103|NCT01740076|"     To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid     levels, inflammation and menopausal symptoms in postmenopausal women.   "
118104|NCT01740063|"     This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with     influenza-like illness (ILI). Subjects will enter the study based on listed     inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza     virus (IFV).      Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose     group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a     placebo group.      The modified intent to treat (mITT) analysis set will include subjects with confirmed     influenza as documented by qPCR or TCID50. The full analysis set will be used for activity     analysis and will include all randomized subjects with baseline and treatment data. Per     protocol, the safety analysis sets are described below in statistical methods.      A subpopulation of 60 participants will also have additional PK and Immunogenicity blood     samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all     study visits.   "
118105|NCT01740050|"     While exposure to an obesogenic environment has increased for almost every individual in     western society, not everyone is equally susceptible to overeating and not everyone becomes     obese. Teasing apart the physiological underpinnings of those individual seemingly     protective- differences may contribute to the development of successful preventive measures     and treatment. Neuroimaging studies started to deliver important insights into the     neuroanatomical determination of individual eating behavior. However, food intake is not only     determined by the brain, but is orchestrated by an interaction of peripheral hormones with     neural circuits and decision-making processes. This interactive axis is also referred to as     the gut-brain axis. While individual aspects of the axis have been studied extensively,     detailed insight in the interaction of gut and brain in the regulation of food intake is     lacking.      Objective: The current study aims to investigate the effect of a) caloric restriction (very     low calorie diet (VLCD)); b) caloric restriction with mechanical restriction (Laparoscopic     adjustable gastric banding (LAGB)); and c) caloric restriction with mechanical restriction     and physiological changes through malapsorption (Roux- en- Y bypass (RYGB) surgery) on     gut-brain interactions to find an optimal balance for weight loss and long-term sustained     weight maintenance.   "
118120|NCT01739855|"     Bariatric surgery leads to rapid weight loss in female and male patients. Less data are     available about its impact on bone metabolism.      The aim of this study is the investigation of changes in bone mineral density,bone     histomorphometric changes, serum bone turnover markers and changes in body fat and muscle     composition in patients after laparoscopic gastric bypass surgery.   "
118121|NCT01739842|"     This study is designed to test whether treatment with kudzu extract will increase the rate at     which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy     (1H-MRS).   "
118106|NCT01740037|"     Rationale: The treatment of patients with atrial fibrillation is often inadequate due to poor     guideline adherence. An integrated chronic care program (ICCP) at a specialized AF-clinic was     found to be superior to usual care provided by a cardiologist in terms of cardiovascular     hospitalizations and cardiovascular mortality.      Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of     cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of     life and guideline adherence.      Objectives: primary objective is to show that an ICCP reduces cardiovascular hospitalizations     and mortality. The secondary objectives include cost-effectiveness, guideline adherence,     quality of life, patient knowledge and patient compliance in medication.      Study design: randomized controlled trial with two study arms: usual care provided by     cardiologists (control) versus ICCP at a specialized AF-clinic (intervention) in 9 hospitals     in the Netherlands. In total 1716 patients with newly diagnosed AF will be included. Total     duration of the study is 4,5 years and total mean follow-up will be 2,4 years. Data collected     at inclusion, after 3, 6, 12 months and every year thereafter.      Study population: Patients older than 18 year with newly diagnosed AF.      Intervention: treatment through an ICCP at specialized AF clinics, consisting of a nurse     specialist, cardiologist-supervisor and a guidelines-based information-communication     technology (ICT) decision support program and a web-based patient centered medication     management tool and tailored telemonitoring.   "
118108|NCT01740011|"     The primary objective of the present trial is to investigate, the mean operative time and to     study the frequency and intensity of postoperative shoulder tip pain in patients undergoing     laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal®     compared with standard pressure CO2 insufflation systems. The primary hypothesis is that     patients operated with AirSeal® have a shorter mean operative time and decreased frequency     and intensity of postoperative shoulder tip pain compared with patients undergoing surgery     with standard pressure CO2 insufflation systems.      It is the secondary objective of the trial to evaluate immunologic and anaesthesiological     aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by     observing the immune responses and volume of mechanical ventilation of the two groups through     measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical     side effects will also be measured as secondary objective.   "
118109|NCT01739998|"     Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from     fish oil) on different inflammatory markers in obese subjects with dietary intervention for     weight lost.   "
118110|NCT01739985|"     The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis     with ondansetron and dexamethasone in children with high risk of postoperative vomiting     (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to     the number of molecules or specific procedures used.   "
118111|NCT01739972|"     Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an     improvement of cognitive function, and an increase in sense of well-being/ quality of life     equivalently compared with L-T4.   "
118112|NCT01739959|"     The investigators examined the hypothesis that serum lactate is raised in early necrotizing     fasciitis to a much greater extent than in other differential diagnoses, such as severe     cellulitis, and therefore provides a diagnostic indicator.   "
118113|NCT01739946|"     The goal of this study is to compare protein markers in the urine of patients with and     without overactive bladder (OAB) and InterStim®.   "
118114|NCT01739933|"     Ventilated ICU patients frequently have sepsis and the majority have delirium, a form of     brain dysfunction that is an independent predictor of increased risk of dying, length of     stay, costs, and prolonged cognitive impairment in survivors. Universally prescribed sedative     medications—the GABA-ergic benzodiazepines—worsen this brain organ dysfunction. The available     alternative sedation regimens, the shorter acting GABA-ergic propofol, and the alpha2     agonist, dexmedetomidine, have both been shown to be superior to benzodiazepines, and yet are     different with regard to their effects on innate immunity, bacterial clearance, apoptosis,     cognition and delirium. The MENDS II study will compare propofol and dexmedetomidine, and     determine the best sedative medication to reduce delirium and improve survival and long-term     brain function in our most vulnerable patients— the ventilated septic patient.   "
118115|NCT01739920|"     The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI)     eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the     standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any     intraocular surgical procedure.   "
118116|NCT01739907|"     Iron deficiency and vitamin D deficiencies are common in menstruating women. The present     assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron     pyrophosphate) or with iron and vitamin D3 in iron deficient women on:        -  Iron metabolism        -  Biomarkers of bone remodelling        -  Cardiovascular risk indexes   "
118117|NCT01739894|"     This is a single arm phase 2 trial evaluating the efficacy and tolerability of     intraperitoneal paclitaxel with oxaliplatin and capecitabine in advanced gastric cancer     patients with peritoneal metastasis and/or cancer cells on peritoneal cytology. Twenty     patients will be recruited into the study for an estimated period of two years. Paclitaxel     will be administered intraperitoneally at 40mg/m2 on Day 1 and 8 in patients receiving     standard intravenous oxaliplatin 130mg/m2 on Day 1 and capecitabine 1000mg/m2 on day 1-14.     The study hypothesizes that the addition of intraperitoneal paclitaxel with chemotherapy will     improve treatment efficacy.   "
118118|NCT01739881|"     The study aims to determine if there are defining EBUS and confocal endoscopy features as     well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses     from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar     gas VOC from patients with lung cancer will be compared against exhaled breath VOC for     signature compounds that may complement CT in screening the population at risk.   "
118119|NCT01739868|"     The main objective of the study is to understand the pathophysiological mechanisms involved     in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2     diabetes risk in the population of patients with pre-diabetes.   "
118122|NCT01739829|"     The purpose of this study is to establish the safety and efficacy of xenotransplantation of     DIABECELL® in patients with established type 1 diabetes mellitus   "
118123|NCT01739816|"     Since October 2010, Swiss community pharmacies can offer a 'Polymedication Check' (PMC) to     patients on ≥4 prescribed drugs taken over ≥3 months.      Aims:      To evaluate first experiences shortly after implementation, missed pharmaceutical care issues     and barriers to implementation on pharmacist's level as well as patient's acceptance through     qualitative and descriptive studies To evaluate the impact of PMC in Swiss primary Care and     to evaluate economic, clinical and humanistic outcomes in a subsequent randomized controlled     trial.   "
118277|NCT01737801|"     Time to perform lung function test after chest physiotherapy in cystic fibrosis.      The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital     capacity).   "
118278|NCT01737788|"     The aim of this study was to evaluate the effect of cervical occlusion versus no cervical     occlusion in women with cervical cerclages.   "
118124|NCT01739803|"     There is a critical gap in the knowledge on how to implement effective interventions for     renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and     clinical outcomes. The objectives of this project were to address this gap through: (1)     designing, implementing, and evaluating a patient-specific behavioral contract intervention     to improve RTRs' IST adherence rates (contracts are written, signed agreements between the     RTR and healthcare provider in which the RTR agrees to be adherent to IST according to     mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs'     health-related quality of life (HQoL) and healthcare utilizations and costs. The primary     hypothesis was that at one year post trial enrollment, RTRs who establish behavioral     contracts with healthcare professionals will be more adherent than those who do not establish     behavioral contracts and subsequently will have greater HQoL and lower healthcare     utilizations and costs. Once it is better understood how to implement effective IST adherence     intervention programs, clinicians will have a valuable tool to promote therapeutic success,     improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the     following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based     intervention on IST adherence; (2) determine the relationship between IST adherence, the     intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the     intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a     randomized controlled trial of the patient-specific behavioral contract-based intervention     was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were     collected over a 12-month period for each RTR study participant and analyzed. This project     will promote healthy lives, increase well-being, and reduce burden of illness and disparity     among adult RTRs by providing data regarding an adherence intervention and the impact of IST     adherence and the behavioral contract intervention on RTRs' health and economic outcomes and     HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs'     graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to     dialysis, morbidity, mortality, and healthcare costs.   "
118125|NCT01739790|"     N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is     widely prescribed for patients with chronic obstructive lung disease (COPD), particularly for     those who have accompanying symptoms of chronic cough and sputum production. Compared to     placebo, high-dose NAC will improve Saint George Respiratory Questionnaire scores in patients     with COPD and chronic bronchitis.   "
118126|NCT01739777|"     The purpose of this study is to determine the safety and clinical effectiveness of umbilical     cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.   "
118127|NCT01739764|"     This open-label, multicenter, non-randomized study will provide continued access to     vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were     previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the     protocol's criteria for disease progression, or are treated beyond progression and are still     deriving clinical benefit (as assessed by investigator), and may therefore potentially     benefit from continued treatment with vemurafenib. Participants will receive treatment with     oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID,     depending on the last dose in the antecedent protocol. Treatment will continue until     progression of disease or as long as the participant is deriving clinical benefit, as judged     by the investigator (case-by-case decision with approval of the Medical Monitor), death,     withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor     to terminate the study, whichever occurs first.   "
118128|NCT01739751|"     Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice     is not good enough to increase the physical activity level. The aim of the study is to     determine the effects of pedometers in the physical level in COPD patients.   "
118129|NCT01739738|"     The purpose of the study is to investigate the impact of ureteral stents on the functioning     of ureteral peristalsis (normal contractions in the ureteral organ muscle).   "
118130|NCT01739725|"     The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and     comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting     the kidney and the bladder) to ultimately improve patient comfort and decrease the need for     painkillers.   "
118131|NCT01739712|"     Sleep intervention for youth with diabetes   "
118132|NCT01739699|"     This is a prospective randomized double blinded trial study involving 128 patients undergoing     any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed     envelope technique. The anesthesiologist and nurses who will be administering the placebo or     intravenous acetaminophen will be blinded to the group in which patients are assigned.      The following general perioperative data will be recorded: patient information/preoperative     data, procedural information, postoperative information, and overall satisfaction of pain     management at 24 hours after surgery.      Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require     no opioids in the first 24 hour postoperative period. With the use of intravenous     acetaminophen, it is hypothesized that the number of patients that do not require opioids in     the first 24 hours after surgery will double.   "
118133|NCT01739686|"     Chronic heart failure is an important public health problem as it is a leading cause of     disability, hospitalization, death, and costs. People who live with advanced chronic heart     failure suffer from numerous symptoms that affect their daily lives. The investigators are     conducting a randomized clinical trial to evaluate a symptom management and psychosocial care     intervention to improve health status (symptom burden, functioning, and quality of life). The     results will be directly relevant to patients and families who suffer with this illness, as     well as to providers, payers, and other researchers.   "
118134|NCT01739673|"     This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application     (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of     infectious keratitis.   "
118135|NCT01739660|"     This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase     administered to hemodialysis patients.      A single dose of pegloticase will be administered intravenously to male or female     hemodialysis patients (N = 12) starting 3 hour prior to dialysis.      The study consists of a Screening Period, a Treatment Period, and Follow up Period.   "
118152|NCT01739439|"     This phase I trial studies the side effects and best dose of radiosurgery boost following     chemoradiation in treating patients with locally advanced pancreatic cancer that may or may     not be removed by surgery. Drugs used in chemotherapy work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery can send x-rays     directly to the tumor and cause less damage to normal tissue. Giving chemotherapy and     radiation therapy together with radiosurgery may kill more tumor cells and allow doctors to     save the part of the body where the cancer started   "
118137|NCT01739634|"     Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some     cases life threatening. Findings in such patients include volume depletion, renal     insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care,     reduced quality of life, and treatment delays. Not all patients benefit from conventional     anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have     water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb     the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will     investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea     in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases     life threatening. Findings in such patients include volume depletion, renal insufficiency,     and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the     incidence and ameliorate the severity of diarrhea in patients with MTC.   "
118138|NCT01739621|"     To further determine the safety and efficacy of Proellex in premenopausal women with uterine     fibroids who have previously completed study ZPV-200.   "
118139|NCT01739608|"     The objectives of this multicenter, randomized trial is to assess the participation rate     achievable through two different screening strategies (Computed Tomographic Colonography-CTC     and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced     adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for     CTC screening will be also assessed. The trial involves 10 Italian centers located in the     Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for     recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family     history or hereditary syndromes; personal history of inflammatory bowel disease; patients     screened by colonoscopy or FOBT within 2 years; severe disease.   "
118140|NCT01739595|"     The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and     reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism     (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with     placebo. Subjects must not have previously been treated with testosterone products within the     last 6 months.   "
118141|NCT01739582|"     To determine the safety profile of Androxal in men with secondary hypogonadism.   "
118142|NCT01739569|"     The aim of this study is to investigate the impact of increased availability of healthy food     and drink during working hours on reaction time and well-being in physicians and nursing     staff.      Hospital medical staff often works long and hectic hours, without adequate meal or rest     breaks in order to provide 24-hour care. This is a concern, as not only the staff's     well-being is important to the individual welfare, but it is also vital to the quality and     safety of the care their patients receive. The investigators believe that by focusing on     physicians and nursing staffs nutrition the investigators will see a positive effect on staff     performance and well-being - and thus ultimately possibly on patient safety.      Hypothesis: The provision of healthy lunch and snack meal during working hours for a period     of 4 weeks will improve reaction time and well-being compared to habitual diet in physicians,     nurses and nursing assistants.   "
118143|NCT01739556|"     Adequate platelet inhibition with dual antiplatelet therapy is a key therapeutic goal after     primary percutaneous coronary intervention (PPCI), aimed at protecting against stent     thrombosis and increased mortality. Recent aggregometric assays have shown that up to one     third of acute coronary syndrome patients treated with clopidogrel have incomplete inhibition     of adenosine diphosphate(ADP)-induced platelet aggregation while the number of patients     treated with aspirin who have incomplete inhibition of thromboxane A2-induced platelet     aggregation (ASPI)is much lower. High on-treatment platelet reactivity (HTPR) has been     associated with an increased rate of ischemic events after PCI. However, recent large trials     did not show a clinical benefit of TPR-guided therapy modification in acute coronary syndrome     patients treated by PCI.      On-treatment PLAtelet reactivity-guided Therapy modification FOR ST-segment elevation     Myocardial infarction (PLATFORM) is an investigator-initiated, prospective, randomized,     parallel-group, controlled clinical trial designed to test the hypothesis that antiplatelet     therapy modification is superior to standard antiplatelet regimen among intermediate to     high-risk STEMI patients undergoing PPCI. The safety hypothesis is that compared with control     arm, interventional study arm will have similar rates of non-coronary artery bypass graft     surgery-related bleeding. Approximately 632 ST-elevation myocardial infarction (STEMI)     patients with intermediate to high-risk (RISK-PCI score >3) clinical features undergoing PPCI     will be randomly allocated to treatment modification or standard treatment. Low responders to     aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive     180 mg ticagrelor for 1 year. Patients will be followed up to 1 year after PPCI.   "
118144|NCT01739543|"     A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.   "
118145|NCT01739530|"     Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques     including cell harvesting from lipoaspirates obtained from healthy donors, expansion of     adipose tissue derived stem cells, and differentiation into pure and immature adipocytes.     This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL     and followed for 8 weeks according to the clinical trial protocol.   "
118146|NCT01739517|"     This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high     in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition     dependent patients with short gut syndrome.   "
118218|NCT01738581|"     This study is exploring a new experimental procedure in dystonia called repetitive     transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of     the study is to determine whether repetitive TMS is effective as a treatment to reduce     symptoms in dystonia as demonstrated by improved motor performance.   "
118147|NCT01739504|"     This will be an open-label, non-randomized, multi-center, patient sponsored study of     Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly     to affected joints.      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the disease pathology of patients with     diagnosed Osteoarthritis.   "
118148|NCT01739491|"     The purpose of this study is to assess safety and effectiveness of extended bendamustine in     the treatment of chronic lymphocytic leukemia (CLL).   "
118149|NCT01739478|"     The aim of this study is to compare the effect of packing and non-packing on the healing rate     of perianal abscess cavities. Secondary objectives are to assess quality of life, cost     effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no     difference in time to healing and non-packing is shown to be safe, acceptable to the patient     and cost effective, this approach may become more widely accepted.   "
118154|NCT01739413|"     Epidural anesthesia has been found to manipulate the hyperglycemic response to surgery. It is     unclear, however, whether the preoperative metabolic status of the surgical patient plays a     role in the degree of this hyperglycemic response. For instance, the presence of low insulin     sensitivity before surgery could predispose the individual to an altered metabolic response     after surgery. In this case, it would be appropriate to identify adequate interventions that     attenuate the response to surgical stress and facilitate the recovery process.      The aims of this research projects are the following:        1. To determine the extent in which epidural local anesthetics, initiated before surgery          and continued after surgery, improves insulin secretion in patients with preoperative          low insulin sensitivity.        2. To understand which measures of postoperative recovery are sensitive to the restoration          of insulin secretion in this particular group of patients   "
118155|NCT01739400|"     Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used     for treatment of Eisenmenger syndrome.   "
118156|NCT01739387|"     This study will compare the patient handling of Flutiform® pMDI (pressurised metered dose     inhaler) and a breath activated device (BAI). Patient handling will be assessed using     assessment criteria which detail the correct handling steps for each inhaler.   "
118157|NCT01739374|"     Pelvic organ prolapse is an herniation process, needing a mesh reconstruction for long     lasting therapeutic effect. Yet, mesh implants were reported to be related to severe adverse     effects. This study looks at the potential benefit of mesh size reduction regarding avoiding     operative complications.   "
118158|NCT01739361|"     Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia,     hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free     hemoglobin in these patient population has been associated with poor outcomes, including an     association with an increased risk of death. Acetaminophen may have a protective effect in     these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose     of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults     with severe sepsis and detectable cell-free hemoglobin.      The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation,     as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis     and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The     secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin     treated with acetaminophen will have better clinical outcomes, including decreased incidence     of acute kidney injury and lower rates of hospital mortality, compared to those who receive     placebo.   "
118159|NCT01739348|"     This study consists of two parts, Part I and Part II. The purpose of Part I of the study is     to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo     administered for 78 weeks in the treatment of Alzheimer's Disease (AD). The primary study     hypotheses for Part I are that at least one verubecestat dose is superior to placebo at 78     weeks of treatment with respect to change from Baseline in Alzheimer's Disease Assessment     Scale Cognitive Subscale (ADAS-Cog) score and that at least one verubecestat dose is superior     to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's     Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score. The first     approximately 400 participants entering Part I of the study are identified as the Safety     Cohort. Participants who complete Part I of the study may choose to participate in Part II,     which is a long term double-blind extension to assess efficacy and safety of verubecestat     administered for up to an additional 260 weeks.   "
118160|NCT01739335|"     Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder. Left     untreated or under-treated, it can become a chronic condition associated with significant     distress, depression, aggression, family disruption, and substance abuse. There is also     accumulating evidence that combat-related PTSD is associated with an increased risk of     morbidity and mortality. For the welfare of returning Veterans with PTSD and their families,     it is critical that this disorder is promptly identified and effectively treated.     Considerable advances that have been made in the assessment and treatment of PTSD in recent     years; however, psychopharmacological treatments have been shown to be largely ineffective     for Veterans with PTSD.      To address this gap, this proposal seeks to test an innovative treatment approach in PTSD -     pharmacological manipulation of the body's major stress system (the     hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is a     glucocorticoid receptor (GR) antagonist with peripheral and central nervous system effects,     making it a compound of interest in the treatment of stress related disorders. There is     abundant evidence of enhanced GR sensitivity in Veterans with PTSD which is thought to     underlie some of the symptoms of PTSD and associated disturbances in mood and cognition.     Thus, blockade of the GR receptor with mifepristone may target unique aspects of PTSD and     lead to clinically meaningful improvement in symptoms and cognition. There is preliminary     evidence that short-term mifepristone treatment has sustained beneficial effects on mood,     cognition and sleep disturbance in some neuropsychiatric conditions (major depression,     bipolar disorder, primary insomnia). That there can be sustained clinical and     neuropsychological effects of mifepristone and normalization of basal HPA axis activity after     drug discontinuation in these disorders, has led to the view that mifepristone's actions     include recalibration of a dysregulated HPA axis. Accordingly, the investigators propose to     study the effects of mifepristone in Veterans with chronic PTSD to determine if it is     efficacious in improving PTSD symptoms and associated clinical outcomes. To better understand     the mechanism of action of mifepristone the investigators propose to assess the effects of     mifepristone on HPA axis activity and their relationship to treatment outcome and clinical     response.      To achieve these objectives, the investigators propose to conduct a Phase IIa, multi-site,     double-blind, placebo controlled trial of mifepristone in Veteran outpatients with     military-related PTSD through the VA's Cooperative Clinical Trial Award program. The     investigators propose to enroll 90 unmedicated male Veterans with military related PTSD at     four VA sites (Salisbury, NC, Bronx, NY, Durham, NC, and San Diego, CA). Eligible Veterans     will be randomly assigned in parallel groups to treatment with 600 mg/day mifepristone or     placebo for one week and followed for up to three months. In this initial trial the     investigators propose to study the effects of mifepristone in Veterans with PTSD as     monotherapy, rather than as an adjunctive treatment, in order to better detect a signal if     there is one.      The investigators will also describe the effects of mifepristone on several other clinical     parameters including PTSD symptomology, depression severity, sleep quality, and functional     impairment. Several measures of neuroendocrine functioning will also be obtained to explore     the relationship of plasma cortisol and adrenocorticotropic hormone (ACTH) levels to clinical     response and the time to addition of rescue medications.   "
118161|NCT01739322|"     The objective of this study is to determine the biologic activity of a Platanus acerifolia     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house     reference preparation (IHRP).   "
118162|NCT01739309|"     The purpose of this study is to estimate the disease control rate with LY2835219 for relapsed     or refractory mantle cell lymphoma.   "
118163|NCT01739296|"     This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar     strapping in knee osteoarthritis treatment.   "
118164|NCT01739283|"     Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and     hypoglycemia in type 1 diabetes.   "
118165|NCT01739270|"     Adding dexamethasone to local anesthetic will significantly prolong duration of brachial     plexus anesthesia and analgesia.   "
118166|NCT01739257|"     The effect of medical humanities on medical student bias and clinical management is unclear.     This study characterized medical student attitudes toward obese individuals and whether     reading a play employing empathic characters can modulate negative reactions.   "
118167|NCT01739244|"     The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local     tolerability and intraocular pressure lowering effect of three different doses of SYL040012     in subjects with ocular hypertension or open-angle glaucoma.   "
118219|NCT01738568|"     Aging is associated with a loss of brain function and conditions such as dementia and     Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the     progression of age related degenerative diseases. Aerobic exercise training can increase     brain volumes and is associated with decreased risk for degenerative brain conditions.     However, little is know about the changes that occur to brain metabolism with aerobic     training and aging.   "
118168|NCT01739231|"     This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527).     ACE527 is a live attenuated vaccine that is being made to prevent disease from     enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children     living in developing countries and in travelers to those countries. This research study is     also testing an investigational adjuvant called dmLT. An adjuvant is something that is added     to a vaccine to make it work better. The purpose of this study is two-fold. First, Part A     aims to find out if the vaccine by itself or the vaccine combined with the adjuvant is safe,     tolerable, and initiates an immune response. Second, Part B aims to find out if the vaccine     by itself or the vaccine combined with teh adjuvant prevents diarrheal disease when     challenged with ETEC H10407. About 60 healthy adults, ages 18-50, will participate in Part A,     and they will be required to stay in the research facility for several nights for the first     dose, but will not be required to stay overnight for the second and third doses. Participants     will be assigned to receive either the vaccine alone, the vaccine with adjuvant, or placebo     by mouth. Study procedures include: stool samples, blood samples, and documentation of side     effects. Participants will be involved in study related procedures for about 8 months.      Interested volunteers from Part A will along with volunteers who were never vaccinated in     Part A will return to participate in Part B. These volunteers will be required to stay     overnight in the research facility for several nights after challenge, after which they will     be treated with antibiotics and sent home. Study procedures include stool samples, blood     samples, and documentation of infection with ETEC H10407. If the vaccine with/without     adjuvant is effective, the volunteers should not development diarrhea, but if the vaccine     with/without adjuvant is not effective, the volunteers will have diarrhea for a few days.   "
118279|NCT01737775|"     Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory     distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been     published. The aim of this prospective study is to compare the achievement of diaphragmatic     function depending on the type of surgery (abdominal and head and neck surgery).   "
118169|NCT01739218|"     This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant     bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal,     or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus     paclitaxel with or without bevacizumab before surgery (interval debulking surgery [IDS]).     Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in     participants with resectable cancer. Participants with unresectable cancer will go through     the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.   "
118170|NCT01739205|"     The major objective of this project is to determine if compared to Standard Care (SC), a     Community Approach to Lifestyle Modification for Diabetes (CALM-D) program including diet,     exercise and coping skills training, can decrease depression, weight and HbA1c and improve     medication adherence in low income, primarily Black and Latino/Hispanic, depressed,     overweight, Type 2 diabetic patients seen in a large, comprehensive, community health center.     Type 2 diabetes is a major risk factor for coronary heart disease (CHD). Obesity, poor     glycemic control, depression, low socioeconomic status (SES) and being a member of a     racial/ethnic minority group all increase this risk.      The project will compare 100 CALM-D and 100 SC participants. Following 3 run-in sessions     assessment sessions to determine eligibility, given to both SC and CALM-D participants, SC     patients will be treated in accordance with ADA Clinical Practice Guidelines (2005) and also     assessed by project staff at baseline, 6 months and 1 year. The CALM-D participants will     receive 2 individual stress management and lifestyle sessions followed by 2 weekly group     sessions. Then 4 bi-weekly sessions will be followed by 9 monthly sessions for a total of 17     sessions. Secondary objectives of the project are to determine if compared to SC, CALM-D can     improve glucose tolerance to challenge, insulin resistance, oxidative stress, inflammation,     procoagulation, lipid profile, endothelial function resting blood pressure, cardiac and     vascular function, cardiac morphology, psychosocial functioning and health quality of life.     As many of the participants will already have been prescribed aspirin, statins, oral     hypoglycemics and other medications, an important objective of the project will be to assess     the extent to which improved adherence to medications - a goal of the CALM-D program - can     account for improved intervention effects.   "
118171|NCT01739192|"     The research proposed in this application will determine the initial efficacy, safety and     tolerability of a novel drug combination, bupropion and naltrexone, as a pharmacotherapy for     cocaine dependence. A rigorous, inpatient human laboratory study will be conducted. The     proposed study is innovative and important because it will provide the impetus for the     conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of     bupropion-naltrexone combinations for managing cocaine dependence.   "
118172|NCT01739179|"     Ventriculoperitoneal shunting (VPS) was first described at the beginning of the 20th century     as a diversionary procedure in patients with a hydrocephalus. After the introduction of     silastic catheters in the 1970's this method became the treatment of choice for children and     adults with communicating hydrocephalus. The average patient necessitating VPS will undergo     at least two shunt revisions every three years, with some patients requiring more than twenty     revisions within the first year. Therefore, any technical improvement with a positive impact     on the revision rate not only benefits the patient through a reduction of the surgical burden     but may also have economic advantages.      Distal shunt failures - either due to improper placement or secondary dislocation of the     distal catheter out of the peritoneal cavity - have been reported in 10-30% of cases.     Catheter placement in obese patients and in patients with adhesions owing to previous     abdominal surgery remains challenging. Most neurosurgeons will carry out a mini-laparotomy to     allow for the placement of the distal catheter end within the peritoneal cavity, which rarely     requires the help of a general or visceral surgeon.      An alternative to laparotomy is the laparoscopic placement of the peritoneal catheter in VPS.     Retrospective series have since shown the safety of this procedure and suggested an advantage     of laparoscopic VPS in terms of operation duration, length of hospital stay and the rate of     distal (and thus potentially overall) shunt dysfunction.      The evidence concerning the effect of laparoscopic surgery for VPS placement is so far based     on non-randomized studies, in which a selection bias may have influenced the outcomes.   "
118173|NCT01739166|"     Funded by the Ohio Department of Job and Family Services - Medicaid Technical Assistance and     Policy Program (MEDTAPP), the Child Health Excellence Center - a University-Practice-Public     Partnership (CHEC-UPPP) focuses on improving the health of Ohio's children in 3 target     areas: 1) prevention of dental decay; 2) detection and management of overweight and obesity;     and 3) lead screening. These topics represent critical public health issues for Ohio's     children.      The study is based on strong evidence that interventions are needed to improve practice in     the target areas and that achieving these goals represents fundamental improvements in child     health care that would reduce morbidity and costs. The approach for the study involves a     trained Practice Facilitator (PF) working with multiple pediatric and family medicine     practices to create change tailored to individual practice preferences and methods of     operation.      Our overall hypothesis is that a university-community consortium, utilizing evidence-based     methods (involving education plus a facilitated, practice-tailored approach) will increase     the rates of targeted services in primary care practices.   "
118236|NCT01738347|"     To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the     Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and     participants with relapsing and remitting multiple sclerosis.   "
118174|NCT01739153|"     The main objective of the current study is to examine whether a high intake of regular-fat     cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of     either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on     fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin     sensitivity is investigated.      To do this, a randomized crossover intervention study with 3x14 days full diet periods     (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between     the diet periods there will be at least 14 days of wash-out where the subjects eat their     habitual diets. Fasting blood samples will be drawn before and after the diet periods, and     also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total     feces is collected the last 5 days of each diet period.   "
118175|NCT01739140|"     This is a study to better understand how a yoga intervention helps improve symptoms in people     with chronic low back pain. This study will be a 12-week intervention of about 24     participants with chronic low back pain where all individuals will receive weekly yoga     classes and instructions for home practice. The purpose of this study is to collect     feasibility data and to conduct preliminary analyses in preparation for a larger planned NIH     study.   "
118176|NCT01739127|"     The purpose of this study is to compare abdominal weight gain and fat distribution in people     taking aripiprazole versus risperidone or quetiapine, to people not taking any of these     antipsychotic medications.   "
118177|NCT01739114|"     To determine if respiratory support at birth guided by RFM decreases BPD.   "
118178|NCT01739101|"     Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and     have unrealistic family planning intentions and insufficient knowledge of health promoting     lifestyle prior to conception. Without sufficient support from the health care system this     can lead to negative consequences. The aim of our study was to investigate if the usage of     the Reproductive Life Plan in midwifery counselling increases women's knowledge of     reproduction and particularly knowledge of folic acid intake prior to pregnancy. Secondary     aims were to evaluate the influence on women's family planning and to further explore how     women experienced the Reproductive Life Plan-based counselling.   "
118179|NCT01739088|"     In 2012, infants having surgery for congenital heart disease have a high survival. The     investigators are now focused on improving how sick these infants become after surgery (short     term outcomes) and their later neurodevelopment (long term outcomes). During heart surgery,     cardiopulmonary bypass (CPB; the heart-lung machine) takes over heart function while the     surgeon repairs the heart disease. During this surgery there are periods of time when the     amount of blood going to the heart and brain is lower than usual, called ischemia. Once the     surgery is finished the blood going to the heart and brain is increased to normal again,     called reperfusion. This ischemia-reperfusion can cause injury to the heart, brain, and     other organs, affecting the short and long term outcomes in these infants. Adult studies have     shown that a short time of ischemia to the legs for 5-10 minutes [the legs are not damaged by     a short time of ischemia, unlike the heart or brain], before severe ischemia to another     distant vulnerable vital organ [like the heart or brain], can protect this other vital organ     from ischemia-reperfusion injury. This is called remote ischemic preconditioning (RIPC).     Our objective is to test whether RIPC before heart surgery can improve the recovery of the     heart and brain after heart surgery in newborn babies with congenital heart disease. The     investigators will test whether RIPC will result in lower peak lactate and troponin levels on     the day after heart surgery. Lactate levels are a marker for how much the different tissues     of the body suffer from ischemia-reperfusion injury. Troponin is released from damaged heart     during ischemia-reperfusion. In our trial infants will be randomized to RIPC or control. This     means each baby has an equal chance of being in one group or the other. The intervention     group will have RIPC before surgery; the control group will not. The investigators hope     this trial will lead to a larger study to test if RIPC results in fewer days on a breathing     machine after surgery, lower mortality, and higher scores on neurodevelopmental tests at 2     years of age.   "
118180|NCT01739075|"     The purpose of this study is to determine whether a novel non-invasive method to estimate     coronary blood flow (FFRct) is applicable to evaluate the functional significance of coronary     stenoses in non-culprit vessels in a population of patients with recent STEMI (ST-elevation     myocardial infarction) and multivessel disease. The diagnostic performance and     reproducibility of FFRct as well as the qualitative and quantitative correlation between     FFRct and the regional coronary blood flow will be examined.   "
118181|NCT01739062|"     The preferred method for early detection of prostate cancer (PCa) in older men with family     history is the Prostate Specific Antigen test (PSA test), although the method is imprecise.     It produces a high number of false-positive results and increases the risk of over-diagnosis     and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic     screening. Genetic risk assessment may be a better way to identify men with low risk of PCa.     The main study hypothesis is that genetic information about low risk of PCa can reduce the     number of patients who get a PSA test as part of unsystematic screening.   "
118182|NCT01739049|"     Malaysia has increasing challenges in lifestyle related diseases, which is related to eating     habits and disorders. According to the National Health & Morbidity Survey in 2011; it was     reported the prevalence of obesity is 15.1% in 2011; or 2.5 million of the population,; an     increase of 7/9% when compared to the 14% prevalence in 2006. Binge eating is a symptom     described in various eating disorders. It is an under-diagnosed medical condition closely     linked to higher body mass index (BMI) or obesity as well as personality psychopathology,     psychiatric and psychological disturbances. Meta-analysis has demonstrated that extremely     strict restriction in dietary calorie and fat intake is needed to achieve meaningful weight     loss. Appetite and satiety are influenced by extremely complex central and gut-related     hormonal systems which modulate the regulation of food intake Centrally acting hormones     include Neuropeptide Y (NPY), agouti gene-related peptide, orexin which are     appetite-stimulating, melanocortins and alpha-melanocortin-stimulating hormone which promote     satiety.      Gut-related peptides include ghrelin secreted by the stomach and the duodenum has orexigenic     (appetite stimulating) effect; leptin secreted by adipose tissue has anorexic (appetite     inhibiting) effect, cholecystokinin, glucagon-like peptide-1 (GLP-1) secreted by the proximal     gastrointestinal tract which has slight anorexic effect, and peptide YY (PYY).      Appetite and obesity have also been commonly related to stress and may influence binge-eating     episodes. Previous studies have demonstrated that high stress hormone cortisol is associated     with increased appetite and cravings, with preference for high carbohydrate content, thus     leading to weight gain.      In the previous study performed by our group on 738 normal subjects who were staffs of the     Ministry of Health, Putrajaya, we found a prevalence of 19% binge eating behaviour, 83% of     whom were either obese or overweight.      GLP-1 analogue used for the treatment of type 2 diabetes and is also shown to produce and     maintain weight loss. Liraglutide, which provides a supra physiological amount of GLP-1 may     cause appetite inhibition thus may benefit in reducing binge eating. The aim of this study is     to closely observe the extensive profile of neuropeptide Y, ghrelin, leptin and GLP-1,     influenced by a standard meal in binge eaters in comparison to non-binge eating controls. In     addition, we aim to determine the association between binging and the respective     appetite-related hormones and also cortisol. Finally we will also be assessing the efficacy     of novel hormonal treatment of Liraglutide in reducing binge eating.   "
118220|NCT01738555|"     This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received     treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it.     This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir     (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and     lopinavir/ritonavir for 36 weeks.      Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg     twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir     (400 mg/100 mg twice daily) for additional 36 weeks.   "
118183|NCT01739036|"     This is an open label, multi-centre phase I/IIa sporozoite-challenge trial to assess the     safety, immunogenicity and efficacy of two combination ChAd63-MVA heterologous prime-boost     vaccination regimens. All volunteers recruited will be healthy, malaria naïve adults aged     between 18 and 45 years.      To determine the efficacy of each of two combinations of heterologous prime-boost     immunisation strategies:        1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS        2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and     Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in     Southampton, UK. The malaria challenge will take place at the insectary at Imperial College     (Infection and Immunity Section) in London, UK.   "
118184|NCT01739023|"     The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC)     transplantation in subjects with subacute SCI.      For humans with subacute SCI, we hypothesize that axons might show improved function if     myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation     may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects.   "
118185|NCT01739010|"     The purpose of this study is to investigate the long term outcome of patients who receive     hypothermia treatment for spinal cord injury. At this institution, intravascular hypothermia     has been used for certain patients with spinal cord injury for the past two years. This study     will collect data from vital signs and examinations while the patient is in the hospital and     also when they follow up as an outpatient after they are discharged or go to a rehabilitation     center. This data will then be analyzed and compared only to historically published data from     previous studies. The aim of this investigation is to determine if intravascular hypothermia     results in a beneficial outcome for patients with spinal cord injury.   "
118186|NCT01738997|"     Although balloon dilatation is the primary treatment for benign dysphagia, information about     the optimal inflation time is lacking. The aim of the current pilot study was to compare 10     seconds inflation time, with 2 minutes inflation time, regarding the efficacy   "
118187|NCT01738984|"     This Phase II Small Business Technology Transfer(STTR) project will develop and test the     effectiveness of an interactive web program optimized for use on a Internet connected     television(TV), titled Moms Exercising or (MomZing) that is designed specifically for women     with infants 2-8 months old. Moms will select from a menu of 98, 10-minute exercise videos     demonstrating yoga, aerobics, and strengthening exercises. They select and sequence together     exercise videos personalized to their fitness level, form of exercise, and the choice to     actively exercise with her baby or alone. The primary health goal of the MomZing Program is     to increase home-based Moderate to Vigorous Physical Activity (MPVA) minutes per week in new     mothers and to maintain their exercise increases over time as their baby grows.      The investigators hypothesize that women that use the MomZing Program will have greater     increases in physical activity and fewer will return to cigarette smoking or alcohol use,     compared to women who use a standard mommy and me exercise DVD.   "
118188|NCT01738971|"     Pharmacists do not provide immediate contraception to women after emergency contraception     (EC); they can only give advice on local contraceptive services.      The investigators wish to establish the following 2 pharmacy- based interventions in NHS     Lothian, designed to increase uptake of effective contraception as soon as possible, after EC        1. Pharmacists would provide one packet of progestogen-only pills, giving women one month          to arrange an appointment with contraceptive services.        2. Rapid access to a family planning clinic upon presentation of the empty EC packet. Women          would be seen as a 'walk-in' and contraception provided.      If feasible, these interventions could reduce unintended pregnancies.      Participating pharmacies will be randomised to provide one of the interventions, or standard     care (verbal/written advice on local contraceptive services).      Women requesting EC from study pharmacies will be recruited by the research nurse/doctor to     participate in the study that will involve them consenting to contact by telephone 6-8 weeks     after EC by the researcher, to evaluate the interventions in terms of :      (i) determine women's experiences/ views of the interventions and control. (ii) determine if     women have commenced effective contraception and if not , reasons why.      A subset of 12 women will also be invited for in-depth interview to collect more detailed     qualitative data on their EC experience.      The investigators also wish to (iii) explore pharmacists views on the interventions      Data from this pilot will enable the investigators to determine whether a larger multisite     study is feasible. The aims of a larger study being to determine if either of the two     interventions being tested result in an increased proportion of women using effective ongoing     contraception compared to the control.   "
118189|NCT01738958|"     Clinical trials in children and adults have suggested that daily consumption of probiotic     lactic acid bacteria can reduce caries risk and caries development in primary teeth in     preschool and stop root caries in the elderly. However, it is not known whether probiotic     bacteria can affect the increased porosity in young permanent teeth in children and     adolescents with many cavities.      It can be difficult to measure the increased porosity of the enamel by tooth decay, but this     can be done using quantitative laser fluorescence (QLF). The method is based on visible light     with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and     green color tones and the dominant color of the enamel is green. Increased porosity of the     enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the     mineral can be quantified by means of a corresponding software.      The purpose of this study is to investigate the effect of a daily supplement of probiotic     lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis     is that the mineral content will not differ from baseline in either the test group or the     placebo group.   "
118221|NCT01738542|"     A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind     was performed in 30 male patients (50-60 years old) with Intermittent Claudication     (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6     months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period     of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2     weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks     and 125 mg twice daily/eight weeks) or control group.   "
144032|NCT01399138|"     The purpose of this study is to examine the effects of a blueberry powder on insulin     sensitivity, blood pressure, and vascular reactivity in subjects with metabolic syndrome.   "
118190|NCT01738945|"     In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most     prevalent underlying disease of people in developed countries. A wide range of studies have     been carried out, from various points of view, to understand the progress of renal     dysfunction in diabetic nephropathy.      Fibroblast growth factor 23 (FGF-23) is a primary regulator of renal phosphate excretion.     FGF23 is inversely associated with the GFR, a relationship underlying a fundamental mechanism     for maintaining serum phosphate constancy during CKD progression. Such an adaptation may have     deleterious trade-offs because, independently of serum phosphate, high FGF23 signals a high     risk of death in ESRD patients. Some studies showed that there is relationship between FGF-23     levels and proteinuria in CKD patients.      There is no data about the effects of calcium channel blocker on FGF23 levels in diabetic     patients with proteinuria. The aim of this study was to find out whether the beneficial     effects of calcium channel blocker in diabetic proteinuria has any relation with the     alteration of FGF-23 levels. The investigators searched for the effects of calcium channel     blocker amlodipine on the clinical and laboratory parameters of diabetic patients with     proteinuria.      The investigators registered the study 'The effect of renin angiotensin system Blockage     (RAS), calcium channel blocker and combined drugs on TWEAK, PTX3 and FMD levels in Diabetic     Proteinuric Patients with Hypertension' (ClinicalTrials.gov Identifier:NCT00921570). The     investigators will use the samples of the some patients for this study. The investigators     also registered the study 'FGF-23 and Endothelial Dysfunction in Diabetic Proteinuric     Patients' (ClinicalTrials.gov Identifier: NCT01703234). The investigators will combine these     two registered studies (NCT00921570 and NCT01703234) in one study.   "
118191|NCT01738932|"     The purpose of the study is to investigate the possible association between low levels of MBL     and the development of endometriosis   "
118192|NCT01738919|"     Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the     distal phalanx, with or without fracture.      Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is     controversial. There are to our knowledge no randomized controlled trials comparing splinting     and surgical treatment with extension block technique.      The aim of this study is to compare splinting and surgical extension block fixation of mallet     finger fractures in a randomized controlled trial.Our hypothesis is that conservative     treatment with splinting is comparable to surgical treatment concerning functional outcome,     and may even reduce the complication rates.      The original protocol was designed to include participants with non-subluxated and subluxated     mallet finger fractures. However this study only included participants with non-subluxated     fingers.   "
118210|NCT01738685|"     Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy     (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated     with physical and emotional concerns. I propose to evaluate the feasibility and preliminary     effectiveness of a behavioral intervention to facilitate problem identification, provide     education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the     intervention intends to empower women to engage in better self-care and seek out resources     they need, which, in turn, will lead to better symptom management.   "
118211|NCT01738672|"     Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor     epidural anesthesia rate by 15%.      Specific Aim: To determine if nitrous oxide can be an effective alternative technique for the     provision of labor analgesia at Magee-Womens Hospital.   "
118193|NCT01738906|"     Rationale      It has been shown in several studies that alcohol increases subsequent food intake. However,     moderate alcohol consumption has no clear effects on hunger and satiety hormones. In the     Western world, where palatable food is highly available, food reward may play an important     role in food intake. Alcohol consumption is known to stimulate neurotransmitters important     for food reward and may therefore stimulate the reward response on a subsequent meal. This     may lead to higher food consumption than when no alcohol is consumed. It is hypothesized that     the reward response of food or beverages can already be generated when food or beverages are     sensed in the mouth, because oral nutrient sensing is known to induce a satiety response     (i.e. the cephalic phase response). Moreover, taste buds directly signal brain areas closely     connected to the reward areas in the brain.      Primary objective        -  To determine whether moderate alcohol consumption influences subsequent food reward, as          measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood          parameters related to reward.      Secondary objectives        -  To determine whether food reward is different when food is consumed than when food is          sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking',          and salivary and blood parameters related to food reward.        -  To determine whether moderate alcohol consumption influences subsequent food reward          differently when food is consumed than when food is sensed in the mouth, as measured by          questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters          related to food reward.   "
118194|NCT01738893|"     The objective of this study was to confirm if two formulations of gabapentin (capsules) are     bioequivalent.      Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product     Nerotin® 300 mg (Pfizer). One capsule was the single dosage.      The study was prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods, under fasting conditions.      The population was composed of 26 healthy volunteers, both genders, adults between 18-55     years.      The comparative bioavailability of the two formulations was evaluated based in statistical     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations     in blood.   "
118195|NCT01738880|"     In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to     reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported to     cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to insufficient     fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid     accumulation. However, the guideline for perioperative fluid management has not been yet     established. The investigators hypothesized that intraoperative fluid management according to     SVV(Stroke Volume Variation)could reduce perioperative metabolic acidosis compared to those     by CVP(Central Venous Pressure). Therefore, the study is trying to determine if     intraoperative fluid administration based on SVV could reduce metabolic acidosis when     compared with CVP in patients undergoing craniotomy due to brain tumor who receive 0.9%     normal saline as main fluid regimen.   "
118222|NCT01738529|"     A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy     (CLE) together with standard white light colonoscopy including inter- and intra-observation     of patients with Crohn's disease.   "
118268|NCT01737918|"     Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We     repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin     can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be     repaired.   "
118196|NCT01738867|"     A total of at least 48 healthy subjects with a history of social drinking will be recruited     into this single-centre, randomized, double-blind, cross-over study. Subjects will be     genetically stratified to result in equal numbers of A118G 'AA' homozygotes (n=24) and A118G     'G' carriers (n=24).      Subjects will participate in all three treatment periods and will be randomized to receive     each of the following for 5 days: Treatment A: Placebo, Treatment B: Naltrexone (NTX) 50 mg     once daily (25 mg once daily for the first two days) and Treatment C: GSK1521498 10 mg once     daily. A washout period will be of at least 14 days between treatments. Subjects will return     for a follow-up visit 7-10 days after the final treatment session washout period has been     completed.      Subjects will attend the clinical research unit on days 1, 2, 3, 4 and 5 to monitor safety     and tolerability for both drugs. Subjects will attend the clinical unit on days 4 and 5 for a     two day assessment, using a series of pharmacodynamic measurements known to be sensitive to     the effects of GSK1521498 and/or NTX: Functional brain response to alcohol and food cues;     plasma cortisol; hedonic and consummatory eating behaviors; subjective response to an ethanol     challenge; experimental pain threshold; and cognitive tests of attention bias towards alcohol     and food cues.   "
118197|NCT01738854|"     The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway     with modification. The parameters about airway sealing such as oropharyngeal leak pressure     (OLP) and leakage volume are important markers of efficacy and safety when using the     supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal     mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at     various intracuff pressure in children.   "
118198|NCT01738841|"     This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in     routine practice in children aged 12 months to 12 years living in the Philippines.   "
118199|NCT01738828|"     The GLOBAL study is an international multi-center, prospective study designed to enroll up to     10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography     for assessment of suspected coronary artery disease (CAD).      The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in     patients phenotyped using advanced imaging modalities of atherosclerosis.   "
118200|NCT01738815|"     The goal of this study is to test whether the drug valproic acid can cause changes in bladder     tumors that might inhibit their growth.   "
118201|NCT01738802|"     This study is evaluating the impact of antioxidant supplements on blood sugar control and     cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes.     The investigators hypothesize that daily supplementation with a multiple micronutrient     formulation containing dietary and endogenous antioxidants in combination with usual care     will reduce markers of oxidative stress and inflammation in Type 2 diabetes.   "
118212|NCT01738659|"     The aim of the study was to verify the effects of moderate versus low sodium intake on     pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue     Doppler imaging in patients suffering from compensated heart failure.   "
118213|NCT01738646|"     It has been shown that bevacizumab has significant anti-tumor activity in patients with     recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against     malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics.     Patients will be treated with a combination of bevacizumab and vorinostat.   "
118202|NCT01738789|"     An adnexal mass is the most common indication for gynaecological surgery . Pre operative     characterization is crucial and a scoring system would be useful to standardize the imaging     report and thus, improve patient management. Recently, our center developed the first MR     scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and     reproducible (1). Our objectives are to perform an external prospective validation of this     scoring system, to evaluate its potential impact on therapeutic strategy and to test its     reproducibility.      This is a prospective large multicenter study. All patients with a sonographically     indeterminate adnexal mass referred for MR imaging will be consecutively included in each     center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior     and one junior radiologists independently analyze the different MR criteria to characterize     adnexal masses. The MR report will be issued as standard and the patient will be managed     accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The     classification will be compared to the reference standard as defined below. The     reproducibility of the classification will be tested between the junior and the senior     radiologist. After anonymisation, images will be analyzed by another senior radiologist of     another center blinded from any clinical or ultrasonographical data and correlated with the     reference standard.      Reference standard: Reference standard will be surgical procedure with histology or standard     clinical follow-up depending on most appropriate routine practice.      Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided     type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a     different PPV. It would thus be necessary to have at least 569 patients classified as SCORE     2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming     6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340     patients will be included in this study to insure a probability of at least 95% to obtain the     aforementioned number of patients in each score category. The inclusion period will last 18     months (extension for a period of 12 months) and monitoring will continue for 2 years.      Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system     for Adnexal Masses. Radiology 2013, May;267(2):432-43.   "
118203|NCT01738776|"     Low Body Mass Index (BMI) is a risk factor for hip fracture, but it is unknown if it is the     low BMI per se that increases risk of hip fracture or if specific micro-nutrients contribute.     The investigators want to elucidate this aspect in a case control study studying     micronutrients in serum and bone turnover markers of hip fracture patients compared with     controls of the same age.   "
118204|NCT01738763|"     The purpose of this study was to assess the acute effects of increasing doses of pinitol on     glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after     consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.   "
118205|NCT01738750|"     This protocol examines choice where it pertains to choosing between two standard methods for     appendectomy, laparoscopic or open procedures, and the affect that cost of the appendectomy     has upon choice.      Children admitted with a diagnosis of uncomplicated appendicitis will be consented to     participate in a study in which the patient can choose between laparoscopic or open     appendectomy procedures. Those that agree to review a consent form will be randomly placed     into one of two groups. The two groups consist of one in which the consent form includes     cost information for each operative procedure in the comparison between the procedures, and     the other group receives a consent form that does not include cost information for each     operative procedure. Both groups also view a short, group specific, computerized     presentation that describes each procedure.      The hypothesis is that those patients given a choice between two similar surgical procedures     and are provided with cost information will more often choose the less expensive surgical     procedure than those that do not have information related to the cost of the surgical     procedures.   "
118206|NCT01738737|"     Osteoarthritis (OA) is a highly prevalent and disabling disease. It is estimated that by 2030     the prevalence of symptomatic OA could reach 30% of the population above 60 years. It is     associated with significant morbidity being one of the most common causes of joint pain,     functional disability and compromised quality of life. This randomised controlled trial will     investigate the effect of low-level laser therapy (LLLT) and static stretching exercises, as     monotherapy and in combination, on pain, quality of life, function, mobility, knee range of     motion (KROM) and hamstring length in participants with knee OA.      This study will involve 145 people aged 50-75 years with symptomatic radiographic knee OA and     will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching     exercises. The patients will be randomly allocated to five study groups LLLT active+Stretch,     LLLT placebo+Stretch, Stretch, LLLT and Control (with n=29 each). Treatment frequency will be     three sessions/week for all active groups. LLLT will involve the use of a Galium-Arsenide     laser (904nm, 40 milliwatts, 3 Joules/point, 27 Joules/knee) over 24 sessions for the     monotherapy group and 9 sessions for the LLLT+Stretch groups. Stretching will consist of     seven exercises completed over 24 sessions. The control group will receive a booklet.      The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes included     quality of life assessed by Western Ontario and McMaster Universities Arthritis Index     (WOMAC), function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test (TUG),     KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The     statistical method will follow the principles of per-protocol analysis.   "
118207|NCT01738724|"     The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume     and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH)     analogs or the progestagen desogestrel or whether it is inferior to other drugs already in     use.   "
118208|NCT01738711|"     Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive lung disease of unknown cause     for which there is no effective medical treatment. The main symptoms are increasing     breathlessness and cough which can significantly impact on quality of life (QOL) often     leading to anxiety and depression. The focus of disease management is shifting from     pharmacological attempts to reduce disease progression to managing symptoms and a more     holistic approach. Cognitive behavioural therapy (CBT) is increasingly used to treat anxiety     and depression in chronic disease. Our investigators aim to determine whether CBT can reduce     anxiety and depression related to symptoms and improve QOL in patients with IPF. This study     will compare CBT intervention (Group 1) against standard treatment (Group 2). Patients will     be recruited from a specialist IPF clinic - all patients attending with IPF who suffer from     anxiety will be eligible to participate in the study. The study aims to recruit 30 patients     (15 in each group). Patients will be randomly allocated into each group using an envelope     concealment system. At entry a baseline visit will be conducted with information gathered     regarding disease severity, hospital admissions, medication, symptoms (subjective and     objective), quality of life and anxiety and depression using questionnaires and routine     clinical tests. Patients will then receive CBT intervention (Group 1) or no intervention     (Group 2). Patients receiving CBT will undergo a maximum of 6 (minimum of 2) individual     therapy sessions. Follow up visits for both groups will be conducted at 3, 6, 9 and 12 months     with the same information gathered as at the baseline visit.   "
118214|NCT01738633|"     Background: A recent systematic review showed that patients undergoing esophagectomy for     cancer had scores of physical function, vitality and performance of health in general     significantly lower than those obtained from the reference population. The analysis of the     quality of life at six months follow-up showed that the total score and physical function     were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and     diarrhea were worse six months after esophagectomy. The objective of this study is therefore     to assess the impact of esophageal resections for cancer on the quality of life of patients     and to improve it through simple interventions of post operative care.      The study is divided into two steps.      This is step 2.      At hospital discharge, patients will be randomized into 4 groups receiving respectively:     nutritional and respirology counseling; nutritional counseling alone; respirology counseling     alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at     1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea),     AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.   "
118215|NCT01738620|"     Background: A recent systematic review showed that patients undergoing esophagectomy for     cancer had scores of physical function, vitality and performance of health in general     significantly lower than those obtained from the reference population. The analysis of the     quality of life at six months follow-up showed that the total score and physical function     were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and     diarrhea were worse six months after esophagectomy. The objective of this study is therefore     to assess the impact of esophageal resections for cancer on the quality of life of patients     and to improve it through simple interventions of post operative care.      The study is divided into two steps.      This is step 1.      Patients will be randomized into four groups receiving respectively: psychological counseling     for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay;     psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders     during ICU stay alone; or standard care. The primary end point are the items SL (sleep     disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.   "
118216|NCT01738607|"     The primary aim of this study was to compare the effects of supplementation with one of three     dietary fibers (gum arabic, carboxy-methylcellulose, or psyllium) or a placebo on fecal     incontinence (FI), symptom intolerance, and quality of life in community-living individuals     who have incontinence of loose or liquid feces. A secondary aim was to explore the possible     mechanism(s) underlying the supplements' efficacy (i.e., improvements in stool consistency,     water-holding capacity or gel formation).   "
118217|NCT01738594|"     This randomized phase I trial studies the side effects and the best dose of carfilzomib when     given together with or without romidepsin in treating patients with stage IA-IVB cutaneous     T-cell lymphoma. Carfilzomib and romidepsin may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. It is not yet known whether giving carfilzomib     alone is more effective than when given together with romidepsin.   "
118223|NCT01738516|"     Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow     for better analysis of local and global activity of the cerebral cortex, as compared with     conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first     clinical service in France equipped with such a system.      Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential     information (in the form of connectivity graphs) on cortical networks, either dysfunctional     or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and     during seizures.      So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et     al., 2010). However, since each method is highly sensitive to the type of model that is     assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al.,     2006), none of them has yet demonstrated its effectiveness.   "
118224|NCT01738503|"     This is an open-label study in treatment seeking opioid-dependent subjects for safety,     tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of     subcutaneous injections of depot buprenorphine after induction and stabilization of treatment     seeking subjects onto Subutex.   "
118226|NCT01738477|"     The purpose of this follow-up study is to evaluate the persistence of antibodies against all     the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to     assess immunogenicity and safety of another dose of Boostrix, administered in this study.     This protocol posting deals with objectives and outcome measures of the extension phase. The     objectives and outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT00109330).   "
118227|NCT01738464|"     This research study seeks to provide more insight as to how the microbiome affects or is     affected by conditions causing chronic pelvic pain such as Interstitial Cystitis (IC),     Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Lower Urinary Tract Symptoms     (LUTS), or Overactive bladder (OAB). Depression and many chronic pain disorders are often     related and are poorly understood, and treatment is often not helpful. The goal of this study     is to explain pelvic pain characteristics and causes by studying microbiomes of healthy     people compared to people suffering from IC, CP/CPPS, LUTS, OAB, and Major depression.   "
118228|NCT01738451|"     This is a Phase I, multicenter, 2-part study with Part 1 designed as a safety lead-in and     Part 2 designed to evaluate the effect of GSK2118436 on cardiac repolarization (corrected QT     interval [QTc] duration) as compared with placebo in subjects with V600 BRAF     mutation-positive tumors.      Each part of the study will consist of screening (14 days prior to the start of the study     treatment), treatment and follow-up period (14 days).      In Part 1 in Cohort 1 six subjects will receive GSK2118436 225 mg twice a day (BID) on study     days 1 to 7 and a single 225 milligram (mg) dose on morning of Day 8. Based on the safety     data of subjects in Cohort 1 subjects will be enrolled in Cohort 2 and the dose of GSK2118436     will be escalated to 300 mg BID. If the 225 mg dose of GSK2118436 is not well tolerated in     Cohort 1 (i.e., 2 or more dose-limiting toxicities [DLTs]), then Cohort 2 of Part 1 will not     be initiated and a dose of 150 mg BID of GSK2118436 will be administered in Part 2 of the     study. In Cohort 2 six subjects will receive GSK2118436 300 mg BID on Study Days 1 to 7 and a     single 300 mg dose on the morning of Day 8. Based on the safety data of subjects in Cohort 2     subjects will be enrolled in Part 2. If the 300 mg BID dose level of GSK2118436 is not well     tolerated, then the highest tolerated dose will be selected for Part 2 of the study.      In Part 1 of the study the decision to proceed to the next cohort or Part 2 of the study will     be based on the safety data of at least 6 evaluable subjects (<=1 DLTs during the 14 days     following the first dose of GSK2118436).      In Part 2 of the study eligible subjects will receive a single dose of GSK2118436/placebo (4     capsules of 75 mg/highest tolerated dose) orally on the first 2 days of the study followed by     2 doses daily for 6 days and a single dose on the 9th day. There will be 1 day when a placebo     will be given.      In both the parts of the study serial blood samples for pharmacokinetic (PK) analysis for     GSK2118436 and its metabolites (GSK2285403, GSK2298683 and GSK2167542) will be obtained at     the same time points on the first and last day of dosing (2nd day of dosing also included for     Part 2). Safety electrocardiogram (ECG)s will be performed at several timepoints during the     study. In Part 2 Holter ECG monitoring will be performed for 24 hours on the 1st, 2nd and 9th     days of dosing.   "
118229|NCT01738438|"     In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in     metastatic breast cancer. Data suggest that MET expression and activation are important for     initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy     of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including     MET and VEGFR2, in patients with metastatic TNBC.   "
118230|NCT01738425|"     The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I     clinical study are to evaluate the safety and tolerability of five (5) single and four (4)     multiple increasing oral doses of GIC-1001 compared to placebo, and to evaluate the     pharmacokinetics of GIC-1001 following single and multiple-dose administration in 80 healthy,     18-50 years old male and female subjects. Moreover, the effect of food on the     pharmacokinetics of GIC-1001 in healthy subjects will be assessed. This study is designed     with an integrated, adaptive approach which allows the evaluation of single and multiples     doses of GIC-1001 in a progressive, overlapped fashion.   "
118231|NCT01738412|"     The purpose of this study is the validation of an Electroencephalograph based algorithm for     detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.   "
118232|NCT01738399|"     The purpose of the study is to investigate the long-term (24 weeks) effects of coffee     consumption on insulin sensitivity in insulin resistant individuals.   "
118233|NCT01738386|"     Background:      - Frontotemporal dementia (FTD) is the second most common cause of early-onset dementia.     Alzheimer s disease is the most common. Alzheimer s disease happens most often in the     elderly, but FTD typically appears between 40 and 60 years of age. It also has a strong     genetic component: Up to 40% of FTD cases are linked to positive family histories. Earlier     diagnoses and genetic tests mean that people with FTD will spend more years in earlier stages     of disease, aware that they have it. However, few studies have looked at the personal     experiences or coping styles of people with FTD. Researchers want to interview people with     FTD and their caregivers to understand their experiences with the disease. This information     will help create better treatments and therapies for those affected by FTD.      Objectives:      - To study the experiences of persons with FTD and their primary caregivers.      Eligibility:        -  Individuals at least 18 years of age who have been diagnosed with FTD.        -  Primary caregivers (spouse or partner at least 18 years of age) of individuals who have          been diagnosed with FTD.      Design:        -  Before FTD participants are recruited, a pilot study will test the interview questions.          This pilot study will be given to people with Alzheimer s disease and their caregivers.          It will study how well people with dementia understand the interview questions.        -  FTD study participants will be recruited through dementia care centers.        -  All participants will have in-person interviews. These interviews will take up to 1          hour.        -  Participants with FTD will answer questions about their experience with the disease.          They will talk about their mental abilities, challenges, and coping strategies.        -  Caregivers will answer questions about their experience in caring for someone with FTD.          They will talk about their challenges and coping strategies. They will also talk about          the person with FTD, and how aware they believe that the person is of the dementia          symptoms.        -  All participants will receive a small gift card as compensation for their time.        -  No treatment will be provided as part of this study.   "
118234|NCT01738373|"     The aim of this registry is to provide information, in day-to-day practice, on Plerixafor     prescription modalities in France, over a 13-month period in order to address the health     authorities' request.   "
118235|NCT01738360|"     Primary objectives :        -  To investigate the safety and the tolerability of ATO by IV infusions to patients with          SLE,        -  To determine the maximum tolerated dose of ATO.      Secondary objectives :        -  Evaluation of the clinical and biological response of the SLE to ATO,        -  Time of relapse in case of positive response,        -  Determination of the efficacy,        -  Pharmacokinetic study of ATO.   "
118237|NCT01738334|"     Adults with Attention Deficit Hyperactivity Disorder (ADHD) have impairments in attentional     subsystems of alerting and conflict monitoring. Mindfulness meditation may lead to an     improvement of these deficits, and reduces symptoms of anxiety and depression. However, the     studies that demonstrated these improvements did not use a control group, nor controlled the     use of medication. In the present study the investigators will examine the effects of the     mindfulness practices (same protocol of 8 weekly sessions used in the study that showed     positive effects in this disorder) in the performance of adult patients and healthy people     (with ADHD). Cognitive performance, mood, and the quality of life will be assessed by     validated questionnaires before and after treatment/standby.   "
118238|NCT01738321|"     To date, there are no data in the literature regarding changes in the intracuff pressure     during prolonged surgical procedures. It is possible that the pressure will increase over     time related to gas expansion during equilibration to body temperature. If this is the case,     these patients may be at risk for tracheal damage. This is a prospective study to evaluate     the changes in intracuff pressure over time during prolonged surgical procedures.   "
118239|NCT01738308|"     The goal of this study is to assess the benefits of Healing Touch, an energy based therapy on     post-operative discomfort and the rate of recovery in children. The aims of this study are to     measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence agitation/     emergence delirium (EAD), 3) pain, 4) time to wake-up, 5) time to meet PACU's departure     criteria, 6.) maladaptive behaviors 2 weeks following surgery & 7)readmissions for     complications 2 weeks following surgery.      This is a triple blinded randomized controlled trial with three parallel groups. 240     subjects, ages 3 or 4 will be randomly assigned to receive the usual post-operative care, the     usual care plus a post-operative Healing Touch treatment, or the usual post-operative care     plus a sham Healing Touch treatment done by an untrained research assistant. The participants     & parents, the evaluators, and the principle investigator will be blinded to study group     assignment.   "
118240|NCT01738295|"     The present proposal investigates the role of the cholinergic system (the neurotransmitter     acetylcholine) in improving vision and visual attention. Vision results from a complex     processing of particular stimuli of the visual field. Attention enhances and prolongs the     neural representations of visual input in the visual cortex. It has recently been shown that     attention in the visual cortex depends on cholinergic mechanisms. The action of acetylcholine     in the visual cortex consists in enhancement of the responsiveness to thalamocortical inputs,     depression of local neuronal connections or extrastriate feedback projections and induction     of gamma synchronisation. The investigators hypothesize that these effects are associated     with long-term changes in functional connectivity in the visual cortex, visual attention and     visual learning (improvement of the visual capacities).      In the present proposal, the investigators will test whether the administration of donepezil     (Aricept, 5mg), a drug that increases the level of acetylcholine in the brain, will enhances     the perceptual-cognitive abilities of young adult subjects. Perceptual-cognitive performance     will be assessed in a multiple object tracking (MOT) task in a 3D automatic virtual     environment. MOT is a task where observers are asked to maintain attentional focus on a     limited number of preselected subgroup of elements in a dynamic scene. Multifocal attentional     mechanisms are necessary to process the information. The task will be tested five time at one     week interval to test whether donepezil and training improved the task performance of the     subject, i.e. lead to perceptual learning. This study could help establish an intervention     procedure to improve visual performance of subjects that need it.   "
118241|NCT01738282|"     The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo     on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol     dependent patients receiving Brenda therapy sessions.   "
118242|NCT01738269|"     Aim of this study is to provide specimens for establishing reference values of HE4 in an     apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of     Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to     population of subjects who have signs and symptoms of various benign and malignant diseases,     including ovarian cancer. This reference range will also be compared to the levels of HE4 in     individual subjects who have been diagnosed with ovarian cancer and are being followed     longitudinally for recurrence or progression of their disease.   "
118243|NCT01738256|"     The purpose of this study is to examine the effectiveness and applicability of different     interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as     psychological and physiological health variables are assessed. The interventions are based on     the principles of cognitive behavioural therapy, and delivered either face-to-face, via     mobile phone application, or Internet.   "
118244|NCT01738243|"     Thyroid eye disease (TED) is an autoimmune disease that affects the eye area. The disease     presents with a variety of physical findings, including bulging of the eyes (proptosis),     upper and lower eyelid retraction, and swelling/inflammation of the eye itself.      The disease passes through two phases: active and inactive. The active phase lasts between 18     and 24 months. During this phase, TED signs and symptoms generally worsen and then often     improve. The inactive phase follows, during which the signs and symptoms of TED cease to     improve and usually stabilize.      Lid retraction is a cardinal sign of TED. In addition to potentially causing cornea damage     due to improper lid closure, lid retraction is also very troublesome for patients due to its     cosmetic appearance. The precise pathophysiology of lid retraction is poorly understood, but     a leading hypothesis is that it occurs due to scarring and fibrosis in the muscles that lift     the eyelid.      Currently, the definitive treatment for lid retraction is surgery, which can be used to     lengthen the lid itself or remove inflamed tissue from behind the eye, thus causing the eye     to bulge less. In cases when patients first present to their physician with corneal     ulceration or compression of the optic nerve, surgery may be performed immediately. However,     in most instances, surgical procedures are delayed until the active stage of the disease has     passed. Thus, most patients must endure the cosmetic and irritant symptoms of TED for up to     two years.      Hyaluronic Acid Gels (HAG) have been FDA approved for the treatment of facial rhytids     (wrinkles). They are injected under the skin and work by increasing volume. Recently, some     smaller retrospective research studies have shown that HAG is also effective in correcting     upper and lower eyelid retraction in TED. Hence, HAG may be for patients with active stage     TED. It is also thought that if employed early in active phase disease, HAG may also help to     decrease the severity of associated symptoms and reduce the need for surgery.      The purpose of the current investigation is to define the clinical utility of HAG correction     of upper eyelid in active TED in terms of anatomic (lid position), quantitative (corneal dry     eye signs) and qualitative effects (symptom severity and thyroid related quality of life).   "
118269|NCT01737905|"     This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single     dose study in 24 pediatric patients (4-11 years old) with asthma.      The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2) Study     Visits. All study subjects must be properly consented, under adult supervision, and screened     against the inclusion and exclusion criteria, at the Screening Visit.   "
118245|NCT01738217|"     This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess     the faisability and the capabilities of fluorescence imaging in hepatic surgery, and     specially to help the surgeon while performing liver surgery.      This study will be performed on patient intended to undergo a liver cancer surgery.It will     contain three steps, assessing the following items:        -  Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical          surgical conditions and validate the data obtained in the preclinical phase,        -  Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic          lesions,        -  Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding          per-hepatectomy.           3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the          third step.      Patients will be followed during 4 weeks after the surgery.   "
118246|NCT01738204|"     In order to learn more about women's health issues that occur over the lifespan, the Women's     Health Study: from Adolescence to Adulthood is building a biorepository and database. The     biorepository collects, processes and stores samples (such as urine, saliva, blood, cells,     tissue and peritoneal fluid) until they are needed for research. The database contains     de-identified information about our study participants. The biorepository and database are     being created to serve as a resource for researchers from Boston Children's Hospital, Brigham     and Women's Hospital and outside institutions.   "
118247|NCT01738191|"     The purpose of this study is to determine the safety and effectiveness of a drug called     atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine     (ATM) is an approved drug currently on the market for the treatment of attention deficit. It     works to increase the amount of norepinephrine (a chemical in the brain that helps keep us     awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration     (FDA) to be used in the treatment of PD.   "
118248|NCT01738178|"     Parkinson's disease is a common neurodegenerative disorder in which patients experience     progressive motor disability and many disabling non-motor symptoms. Recent studies have     consistently found that people who do not use caffeine are at higher risk of developing     Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD.      In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the     motor manifestations of disease. There have been other lines of evidence that have suggested     caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg BID     vs matching placebo for motor and non-motor aspects of disease. This will be in three stages.     In the first six-month stage, medications will be held constant, to see whether caffeine does     have motor benefits. Then we will perform a four-year extension stage to define if the     effects of caffeine persist (or even magnify), and to see if caffeine helps reduce dose of     other PD meds and/or prevents their side effects. Finally, we will finish with a six-month     stage in which we will place all patients on caffeine - this will allow us to assess     caffeine's use in later disease, but more importantly, will assess whether early use of     caffeine produces long term changes beyond its immediate effects.   "
118249|NCT01738165|"     The purpose of this pilot study is to collect data on the safety and effectiveness of the     KineSpring System in patients with primarily unicompartmental medial knee osteoarthritis.   "
118250|NCT01738152|"     The purpose of this study is to see whether it is feasible to conduct a study to determine if     the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health.      This study aims to look at whether or not HyaloGYN® is effective in women with a history of     hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen     deprivation following their breast and endometrial cancer treatment.   "
118251|NCT01738139|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of ipilimumab and imatinib that can be given to patients with advanced cancer.     The safety of this drug combination will also be studied.      Ipilimumab is designed to increase the immune system's ability to fight cancer.      Imatinib is designed to bind to certain proteins on the tumor cells, which may prevent the     cells from growing.   "
118252|NCT01738126|"     This K01 application is designed to prepare the applicant with the skills necessary to     establish an independent research program on pain--related processing in the cerebellum.     Although pain studies using functional imaging in humans consistently find cerebellar     activation, the role of this structure during pain is unknown. In such studies, speculation     regarding the cerebellum's function during a painful event is often influenced by its     reputation as a coordinator of motor function, though animal studies have indicated that it     may also modulate the neural encoding of noxious stimuli. The candidate has published work     that indicates a functional dichotomy in the way the cerebellum responds to experimental pain     in healthy subjects and neuropathic pain patients. This suggests that the cerebellum has been     overlooked as a potential pain processing area, and research into this area could lend     invaluable insight into the basic physiological circuitry involved with pain and its     modulation.      The hypothesis of this project is that the cerebellum serves as an integrator of aversive     stimuli and adaptive motor behavior, and may modulate the emotional and cognitive experience     that distinguishes the perception of pain from the appreciation of innocuous sensory     stimulation. A human trigeminal model of experimental pain will be used, as all the     pain--‐related circuitry involved can be imaged along with the cerebellum at the same time.     The specific aims are (1) to map cerebellar activations related to sensory coding of noxious     stimuli and to correlate functional activity with anatomical connectivity using functional     magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI); (2) to distinguish     between pain and its anticipation based on cerebellar responses and connectivity; and (3) to     determine whether physical pain and aversive images engage similar circuitry in the     cerebellum. To accomplish these aims, the candidate will need to expand his background in     fMRI of cortical and brainstem pain processing to encompass cerebellar physiology, become     proficient in DTI analysis, and learn the white matter connectivity to and from the     cerebellum. The research environment at McLean Hospital and the other affiliates of the     Harvard Medical School system will provide the candidate with the resources to reach his aims     within 4 years.   "
118270|NCT01737892|"     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine     Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled     epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous     epinephrine, in healthy male and female adult volunteers. The current study is designed to     complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK.     Safety of E004 will also be evaluated.   "
118271|NCT01737879|"     The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be     converted to epoetin alfa by using a predefined conversion table while achieving a stable     hemoglobin.   "
118272|NCT01737866|"     A phase 1, open-label study in subjects with normal renal function and subjects with various     degrees of renal insufficiency, including patients with end-stage renal disease (ESRD)     requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in     subjects with various degrees of renal insufficiency, including patients with end-stage renal     disease requiring hemodialysis.   "
118253|NCT01738113|"     The Ilizarov external fixator is an external skeletal fixator that is used to stabilize or     lengthen the limb bones. Bone lengthen bone occurs through mechanical distraction on the long     axis of the bone, thus the method of lengthening is called distraction osteogenesis. This     method has been shown successful. Unfortunately, it has also been associated with a     substantial number of complications.      Muscle shortening and persistent weakness are among the most common complications seen in     this procedure. Muscle shortening usually occurs in strong muscle groups such as the planter     flexor muscles, as a result of strength imbalance between the opposing muscle groups.     Shortening may persist for more than a year after the removal of the fixator and may require     surgical intervention. Fortunately, muscular shortening can be prevented by splinting and     physiotherapy in the form of stretching and strengthening exercise and functional training.      The use of different exercises in rehabilitation can help accomplishing different therapeutic     goals. Thus, the choice to use one or the other should depend on the desired treatment goals.     Weight bearing (CKC) and non weight bearing (OKC) exercise has been incorporated into     rehabilitation; however, the effects of these two types of exercises particularly on muscle     flexibility and mechanics have never been studied systematically.      Therefore, the purpose of this is to compare the effects of OKC and the CKC exercise on     muscle strength, architecture and flexibility.      General Hypothesis:      The use of open kinetic or closed kinetic chain exercises will have no different effects on     muscle function or internal organization during tibial distraction osteogenesis by Ilizarov's     method Specific hypotheses        1. There will be no difference between the effects of OKC and CKC on muscle flexibility.        2. There will be no difference between the effect of OKC and CKC exercises on muscle          strength.        3. There will be no difference between the effect of OKC and CKC on the internal          organization of muscle specifically the pennation angle, muscle thickness and fiber          length.        4. There will be no difference between the overall of OKC and CKC exercise on the          functional performance of patients.   "
118254|NCT01738100|"     A 2 by 2 factorial, multicenter, prospective, randomized, open-label, blinded endpoint trial.     Patients undergoing primary PCI for STEMI will be eligible. Enrolled patients will be     randomly assigned to the ticagrelor group or the clopidogrel group in a 1:1 ratio. After     emergent coronary angiography, patients who have thrombolysis in myocardial infarction (TIMI)     flow grade <2 in coronary angiogram will be randomized again, to either bolus intracoronary     injection of morphine sulfate or saline in a 1:1 ratio. Randomization will be stratified by     infarct location (anterior vs. non-anterior), and morphine use for pain control before study     enroll (for only intracoronary morphine).   "
118255|NCT01738087|"     The study is aimed to assess the dose proportional total systemic exposure (when the     administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its     lung bioavailability (when the administration is with the activated charcoal) after single     inhalation of CHF 1535 NEXThaler DPI at two dose strengths.      At the same time, the study will assess if the lung deposition and the total systemic     exposure to Formoterol is affected by increasing doses of BDP.   "
118256|NCT01738074|"     Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe     rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus     genetic reassortment vaccine.   "
118257|NCT01738061|"     The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention     program to reduce the severity of metabolic disorders in older workers in Taiwan.   "
118258|NCT01738048|"     A cross sectional study to determine the prevalence of persistent pain after reconstructive     surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated     with mastectomy without reconstruction.   "
118259|NCT01738035|"     The objective of the study is to evaluate efficacy and safety of two different doses of     NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of     developing end-stage renal disease, under rigorous blood pressure control with an     angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker     (ARB).   "
118260|NCT01738022|"     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The     mechanisms that lead to airway closure are not completely understood. Models to study     mechanisms of airway collapse have been proposed. However, these models have not been tested     in the human upper airway. Gas density and viscosity are different gas properties that     influence upper airway collapse and are variables of different models. In this study,     subjects will breathe gas mixtures of different densities and viscosities for brief periods     of time in order to test those models.   "
118261|NCT01738009|"     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The     mechanisms that lead to airway closure are not completely understood. Some studies have shown     that there is progressive narrowing of the pharyngeal airway across breaths during expiration     (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is     unknown. The investigators will test if lung volumes and low respiratory drive play a role in     PEN.   "
118262|NCT01737996|"     The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics     of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with     faldaprevir in healthy male and female subjects.   "
118263|NCT01737983|"     The purpose of this study is to evaluate in patients with cystic fibrosis the effect of     Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of     both upper respiratory and gastrointestinal tracts.   "
118264|NCT01737970|"     This research proposal concerns a study to monitor the effects of chemotherapy on breast     cancer tumour and peritumour stromal cells using ultrasound (US) elastography (also known as     strain imaging).      Many cancer treatments currently being developed are targeted; that is they exploit     particular biological processes in specific cancer cell types to disrupt tumour growth. Being     able to monitor the efficacy of these typically high-cost drug therapies is essential both     for the best patient outcome as well as offering economical benefits to the health care     system and much needed insight into future drug development.      Ultrasound provides a relatively inexpensive, non-invasive means for imaging cancers, and has     been used widely in breast cancer diagnosis for many years. Its role in therapy monitoring     has been suggested but has not been well explored. The purpose of this proposal is to explore     this potential in more depth.      It has been identified that significant interaction takes place between tumour and stroma     through all stages of tumour growth; this complex relationship is an ongoing topic of     research. Fibrotic changes occur during tumour growth and are also a quintessential process     of healing. Indeed, fibrosis is a common after effect to chemotherapy in many forms of     cancer. Elastography is an established imaging technique (based on ultrasound or MRI) which     can estimate the relative stiffness of tissues in vivo and is thus well-suited to monitor     these particular biological processes.      This elucidates the main hypothesis of this project: fibrosis, cancer cell necrosis and     inflammation may all contribute to a measurable response in elastography. These changes to     the tissue composition can be imaged over a course of a patient's treatment to assess the     response to chemo/hormonal therapy.      The ultimate project goals are to develop a clinical tool (based on ultrasound elastography)     to improve treatment management in addition to offering a better biological understanding of     tumour/stroma behaviour.   "
118265|NCT01737957|"     To determine the safety and efficacy of a single session of low-fluence panretinal     photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of     low-fluence PRP will be safe regarding the progression of macular edema and the presence of     adverse events, and will efficiently induce regression of neovascularization.   "
118266|NCT01737944|"     Pharmacokinetics (PK) study   "
118267|NCT01737931|"     To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines     for application site reaction (ASR) after administration of SPM 962 in healthy subjects   "
118281|NCT01737749|"     The primary objective of the study is to check the ability of Neurokeeper's algorithm system     to detect and monitor changes in cerebral electrophysiological parameters as compared to     clinical evaluation in patients undergoing cardiac surgery.      The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations     as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control,     single center study.      This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.   "
118282|NCT01737736|"     The primary objective of the study is to validate an EEG base algorithm system to detect and     monitor changes in cerebral electrophysiological parameters as compared to clinical     evaluation in patients undergoing Carotid Endarterectomy.      The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection,     time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective,     open label, single arm, self control, single center study.      This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.   "
118283|NCT01737723|"     The purpose of this study is Collecting data for an Electroencephalograph based algorithm for     detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.   "
118284|NCT01737710|"     Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with     severe itching. People who have atopic dermatitis often have complications from skin     infections; these can include eczema herpeticum after herpes simplex virus infection or     eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from     skin infections and may therefore respond differently to vaccinations.      A new flu vaccine which is injected into the skin instead of into muscle has recently been     approved by the Food and Drug Administration for vaccination of the general population     including patients with atopic dermatitis. This new vaccine has been shown to work as well as     the vaccine which is injected into muscle when tested in people without atopic dermatitis.     The main purpose of this study is to compare how people with atopic dermatitis respond to     this new flu vaccine compared to non-atopic volunteers without atopic dermatitis. The second     purpose is to look at how people with atopic dermatitis respond to the new vaccine which is     injected into the skin compared to the vaccine which is injected into muscle.   "
118285|NCT01737697|"     Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo     control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 -     6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).      Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more     effective than placebo control (alternative hypotheses) in maintaining normokalemic levels     (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between     each ZS dose and respective placebo controls (null hypotheses).   "
118286|NCT01737684|"     This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618)     administered to participants with moderate hepatic insufficiency and healthy participants     matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild     hepatic insufficiency.   "
118287|NCT01737671|"     The goal of this clinical research study is to learn if it is safe to receive methotrexate     through the fourth ventricle of the brain in patients with brain tumors.      Methotrexate is designed to block cancer cells from dividing, which may slow or stop their     growth and spread throughout the body. This may cause the cancer cells to die.   "
118288|NCT01737658|"     Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.   "
118289|NCT01737645|"     This study is to determine if there is a rise in eye pressure, when patients are placed in a     position where the head is lower than the rest of the body during long surgeries.   "
118290|NCT01737632|"     The fundamental objective of this study is to compare the effectiveness of an intensive     in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted     residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to     delineate the mechanisms of change for each treatment. The study targets dually- diagnosed     adolescent drug abusers recommended for residential treatment.   "
118291|NCT01737619|"     The goal of this clinical research study is to compare positron emission tomography/computed     tomography (PET/CT) scans and sentinel lymph node mapping in finding lymph nodes that have     endometrial cancer.   "
118292|NCT01737606|"     The new technical of ultrasonic exploration of this project purpose to validate the     measurement of cerebral pulsatility by a new way called Fast Cerebral Pulsatility Imaging     (FCPI).This will somehow determine the natural history of cerebral pulsatility during     development adult to old age   "
118293|NCT01737593|"     Emergence agitation (EA) occurs in up to 67% of pediatric patients after anesthesia for     bilateral myringotomy tubes (BMT, ear tubes). The goal of this study is to find out whether     acetaminophen given well before surgery can decrease pain and therefore, decrease emergence     agitation better than acetaminophen given shortly before or during surgery. EA can be     dangerous for the patient because it may be hard to monitor their vital signs during an     important phase of recovery, they may injure themselves, may require the presence of extra     staff, and it can be very distressing to the parents. Causes of EA are not well understood,     but it can be worsened by pain. 70% of patients undergoing BMT experience pain that needs     treatment. Intranasal fentanyl, a strong analgesic, has been shown to decrease EA, but often     ends up in dose-dependent nausea and vomiting. In previous studies and in common practice,     acetaminophen is given either 30 minutes before induction of anesthesia or immediately after     induction. The peak analgesic effect of acetaminophen is 60-120 minutes. Since the procedure     is generally completed in 5-10 minutes, the therapeutic effect of acetaminophen may not be     present upon emergence from anesthesia.      The purpose of this study is to find out if acetaminophen given 60-120 minutes prior to     emergence can decrease EA in patients undergoing BMT. Patients would be randomized to one of     three groups: Control will receive acetaminophen rectally while under anesthesia (standard     practice), Group 1 will receive acetaminophen 10 mg/kg at 60-120 minutes prior to surgery,     Group 2 will receive acetaminophen 20 mg/kg at 60-120 minutes prior to surgery. All groups     would also receive a dose of intranasal fentanyl during the surgery, which is standard     practice. Patients would be observed in the recovery room at various time points for evidence     of EA and pain.   "
118294|NCT01737580|"     The application of the TLR7/8 (Toll Like Receptor) agonist gel (immune response helper)     resiquimod will enhance the immune response to the intradermal influenza vaccine in seniors     65-75 years of age.   "
118295|NCT01737567|"     Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of     chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band     imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing     White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable     advantage to using one or the other for lesion detection and assessment.   "
118296|NCT01737554|"     Catheter occlusion and dysfunction are common complications of central venous access device     (CVAD) use in children with cancer and hematologic disorders. These events can lead to     interruption of therapy and may require device removal and replacement. Attempts to clear     occlusion can cause device fracture.      There is a clear link between catheter occlusion and other serious complications including     bloodstream infection and intravascular thrombosis.      There is evidence that catheter occlusion or dysfunction may be preceded by subclinical     catheter narrowing, which could be detected by accurate measurement of catheter resistance.      This study aims to observe and describe the feasibility and results of catheter resistance     monitoring (CRM) over time with the aim of prospectively identifying patients at high risk of     catheter occlusion.      If CRM is feasible and proves to be sensitive and specific, it could provide an opportunity     for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection     or thrombosis.   "
118297|NCT01737541|"     This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will     be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment     with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral     hemorrhage.   "
118298|NCT01737528|"     The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world     outcomes related to the transcatheter aortic valve replacement (TAVR) procedure. Created by     The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT     Registry is designed to monitor the safety and efficacy of this new procedure for the     treatment of aortic stenosis.   "
118299|NCT01737515|"     Despite advances in surgical technique, preoperative patient evaluation and post-operative     care, elective colorectal surgery carries a risk of mortality of approximately 2% and a     morbidity rate ranging from 20-40%. Risk prediction is important for two reasons: it informs     decision-making in individual cases before surgery (part of informed consent) and allows the     comparison of actual outcome with predicted outcome. A number of scoring systems for     assessing risk of death after surgery have been developed. They vary from simple scores based     on a few variables to highly complex mathematical models requiring detailed data input.     Recently, the Association Française de Chirurgie conducted a multicentre study to develop and     validate a 4-item predictive score of mortality after colorectal resection which has good     predictive value and is simple to use.      Although many surgeons associate obesity with adverse outcomes, recent large, well-designed     studies have been unable to show that obesity (defined as Body Mass Index (BMI) >30) is an     independent risk factor for major morbidity or mortality after general abdominal surgery.     Recently abdominal obesity (waist measurement >102cm in men and >88cm in women) has been     shown to have better correlation with cardiovascular disease than BMI and is strongly     associated with a clustering of risk factors for cardiovascular disease and diabetes (insulin     resistance, hyperglycaemia, hypertension, dyslipidaemia and abdominal obesity) known as the     metabolic syndrome. Waist circumference and waist/hip ratio are measures of abdominal obesity     that correlate with the amount of intra-abdominal rather than subcutaneous or general body     fat and may be a better measure of the risk of intra-operative complications and     post-operative morbidity following abdominal surgery than BMI.      The study will be prospective and multicentred, with 28 participating units in Belgium,     France, Switzerland and Sweden. The coordinating centre will be UCL St Luc. The study will     start on 1st September 2008 and will aim to include a minimum of 1000 patients. Consecutive     patients undergoing elective colorectal resectional surgery for cancer or diverticulitis will     be included. In addition to normal preoperative assessment, waist and hip circumference will     be measured before surgery and specific data will be collected on intra and post-operative     complications and mortality. Data will be recorded using an encrypted, anonymous database     using variables carefully selected to assess short and long term outcomes. The study will be     the first of its kind to investigate abdominal obesity as a predictive risk factor for     colorectal surgery and will also be one of the biggest prospective studies of morbidity after     colorectal surgery.      The aims of the study are a) to assess if waist measurement or waist/hip ratio is a better     predictive risk factor for complications or mortality after colorectal surgery than BMI, and     b) if this measurement adds accuracy to the AFC score in risk prediction.   "
118300|NCT01737502|"     This phase I/II trial studies the side effects and best dose of auranofin when given together     with sirolimus and to see how well it works in treating patients with lung cancer that has     spread or other places in the body and cannot be cured or controlled by treatment or has come     back after a period of time during which the cancer could not be detected. Auranofin and     sirolimus may stop or slow the growth of lung cancer.   "
118301|NCT01737489|"     The purpose of this study is to determine if aural rehabilitation adds measurable benefit and     participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study     is designed to compare the efficacy of a commercially available aural rehabilitation program     (LACE) and an electronic program which takes advantage of a traditional form of auditory     training (NOOK) for cochlear implant users.   "
118302|NCT01737476|"     The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in     treating attention deficit disorder in adults.   "
118303|NCT01737463|"     Endoscopic snare papillectomy (ESP) is an efficient treatment for benign tumors of the     duodenal major papilla. But post-ESP pancreatitis is the most common and serious     complication. Since one prospective randomized controlled trial showed that pancreatic duct     stent placement reduced post-ESP pancreatitis, almost physicians have tried to place the     pancreatic duct stent after EPS.      The aim of this prospective, randomized, multicenter trial is to compare the rates of     post-ESP pancreatitis in patients who did or did not prophylactic pancreatic duct stent     placement. Consecutive patients who were to undergo ESP were to randomized to pancreatic duct     stent placement group (stent group) after endoscopic snare papillectomy or to no pancreatic     duct stent placement group (no stent group).   "
118304|NCT01737450|"     The aim of this study is to determine the activity, to assess the safety and tolerance of     BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under     platin and cetuximab-based chemotherapy.   "
118305|NCT01737437|"     A previous study demonstrated topical lidocaine spray on the larynx and the trachea is     effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In     clinical practice, blind oropharyngeal application of lidocaine without aiding direct     laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and     trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to     correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during     spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on     direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.   "
118306|NCT01737424|"     To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in     healthy male subjects   "
118307|NCT01737411|"     The purpose of this study is to determine if pelvic surgery can improve urge urinary     incontinence in women more than standard medical treatment.   "
118308|NCT01737398|"     The purpose of this study is to evaluate the efficacy and safety of IONIS-TTR Rx given for 65     weeks in patients with Familial Amyloid Polyneuropathy   "
119898|NCT01716546|"     Investigators propose to study the effect of panitumumab when combined with an active     regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients     with advanced cancer of the stomach.   "
118309|NCT01737385|"     This study examines the microcirculation of the caput humeri after proximal humeral     fracturation using O2C light probes.      During the operation the blood circulation is measured at four points (tuberculum majus,     tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes     are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The     data is analysed in respect to the fracture type according to the classification of Neer.      Valuable additional information for the correct treatment and prognosis of humeral fractures     is expected.   "
118310|NCT01737372|"     This study will look at the blood and cerebrospinal fluid of consented participants who     either have early stage multiple sclerosis (clinically isolated syndrome) or who have later     stage (secondary progressive multiple sclerosis), or participants who do not have any     neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group     differences.   "
118311|NCT01737359|"     This is a double-blind Phase 2a study to test the safety and efficacy of an investigational     HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once     daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing     antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized     to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15)     or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice     daily.      The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300     mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but     then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received     amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in     the 36-week open-label study.   "
118312|NCT01737346|"     The combination therapy of temozolomide and radiation has been established as the standard     therapy for the initial treatment of glioblastoma. However, the prognosis for patients with     recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. There is     no efficient and standard care at the time of recurrence or progression following     temozolomide administration. Recently, many clinicians have reassessed the efficacy of     second-line chemotherapeutic agents such as nitrosoureas for the treatment of     recurrent/refractory glioblastoma. It is very important that the effect of the agent is     sustained and the adverse effect is reduced to preserve the quality of life in recurrent     settings. We have realized that the clinical features of Korean patients are very different     from those of foreign patients. Therefore, it is mandatory to develop the new strategy for     the treatment of Korean patients. We modify the PCV chemotherapy in the dose and     administration schedule of CCNU and procarbazine to reduce the side effect, especially     hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU     and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of     vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC     chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the     first multicenter trial for glioblastoma patients in Korea.   "
118313|NCT01737333|"     Collection of data from different sites regardless of whether they use standard or tailored     protocols for the application of high concentration iodinated contrast agents to assess if     the individually patient-adapted protocols result in a similar diagnostic image quality.   "
118314|NCT01737320|"     The investigators plan an open label randomized controlled trial to compare short-course     antibiotic therapy (<=7 days) versus longer treatment (>7 days). The investigators will     include hospitalized patients with gram-negative bacteremia. The investigators primary     objective is to investigate the safety and efficacy of short-course antibiotics.   "
118315|NCT01737307|"     The purpose of this study was to investigate the effect of Fluoride varnish and Casein     Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and     salivary characteristics in patients under chemotherapy.   "
118316|NCT01737294|"     This non-interventional study will evaluate the efficacy, tolerability, health related     quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is     used in standard clinical practice.      The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into     subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back     pain; cancer-related neuropathic pain; post-operative & post-traumatic neuropathic pain; and     'other' neuropathies.   "
118317|NCT01737281|"     Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates     of smoking-related morbidities compared to the general Veteran population. Smoking cessation     treatment delivery in the VA typically depends on a visit from a health care provider. In     this study, investigators will use information within the electronic medical record to     identify all smokers with a mental health diagnosis at a VA health care facility and     proactively reach out to enroll them in an intensive tobacco cessation treatment program.     This approach could be generalized to other behaviors and provides a novel method to improve     the health of an entire population of patients.   "
118318|NCT01737268|"     FK949E will be administered to elderly bipolar disorder patients with major depressive     episode for 52 weeks. Its safety, efficacy, and plasma concentration change will be evaluated     in an open-label manner.   "
118319|NCT01737255|"     This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53     mutation carriers and population controls, with the hypothesis that more cancers will be     detected in the TP53 mutation carrier group. A secondary end-point will be the number of     incidental findings detected and subsequent investigations required. A series of     questionnaires will be used to assess the psychological impact of screening on both the study     and control group.   "
118320|NCT01737242|"     The UKGPCS was set up to find genetic alterations which occur in patients who have prostate     cancer.      A man's risk of developing prostate cancer increases if he has a first-degree relative     (father or brother) who was diagnosed with prostate cancer at a young age. This is why we are     looking for men who are affected at a young age or who have a family history of prostate     cancer, since it is more probable that these prostate cancers are due to an inherited genetic     cause rather than an environmental cause.      We also ask all men who come to the Royal Marsden Hospital to be treated for prostate cancer     if they would like to take part in the study so that we can also look to see if we find     genetic alterations in older men, and those who do not have a family history of prostate     cancer.   "
118321|NCT01737229|"     TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of     RD94 in patients needing endodontic care, medical device class III.      SPONSOR:      SEPTODONT, 58 rue de Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33     1-49-76-74-26, Fax. : + 33 1- 49-76-71-91      Reference protocol: 09/001      PRODUCT NAME: Biodentine™ (RD94)      MEDICAL DEVICE:      Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application :     one single time      DEVELOPMENTAL PHASE: not applicable (medical device class III)   "
118322|NCT01737216|"     Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients     with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with     first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the     lumbar spine and total hip.   "
118323|NCT01737203|"     The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without     water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under     fasted conditions.   "
118324|NCT01737190|"     The aim of the study is to examine the effects of two different levels of PEEP on subsequent     standard recruitment maneuver.   "
118325|NCT01737177|"     This is a prospective, multicenter phase II trial designed to evaluate the safety and     activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients     with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a     maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to     24) for those responding to the induction.   "
118326|NCT01737164|"     Aging is a major risk factor for the development of type 2 diabetes (T2DM). Approximately 50%     of subjects aged ≥65 have diabetes or impaired glucose tolerance, a pre-diabetic state.     Purpose: In the proposed study, the investigators will test the hypotheses that the decrease     in fat oxidation that occurs in muscle from older human subjects is secondary to an     age-mediated reduction in AMPK signaling, in vivo, and that upregulating AMPK signaling     through exercise training will result in (and correlate with) increased fat oxidation,     reduced intramyocellular lipids, and improved insulin action.   "
118327|NCT01737151|"     This clinical trial studies stereotactic body radiation therapy in treating patients with     low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able     to send x-rays directly to the tumor and cause less damage to normal tissue.   "
118328|NCT01737138|"     To study whether renal sympathetic denervation(RSD) is safe and effective in patients with     chronic kidney disease and resistant hypertension   "
118329|NCT01737125|"     The distal tibio-fibular joint ( DTFJ) be an integral part of the ankle and its injury makes     all the gravity, forecast and complexity of ankle fracture treatment. It's classically     described and known by radiological point of view, but in static incidence and from     anatomical studies. To our knowledge the dynamic dimension and its modelling is missing. Our     study will use high spatial-resolution MRI acquisition to obtain the best possible definition     of DTFJ but especially it will be associated with MRI acquisition in movement, using typical     fast sequences  TrueFISP  and FLASH which will allow a precise modelling of joint     physiological movements and biomechanics on healthy subjects by a not invasive method. This     analysis will be made on a simple movement of flexion and extension, the other possible     movements of the ankle being blocked what corresponds to the clinical situation of an     osteosynthesis ankle immobilized in post-operative by a dynamic rehabilitation shoe Axmed ®     It will be associated aneffort test  with the reproduction of subjected joint of a load     with MRI joint movement control This test will be made with an ankle fixed to 90 ° of flexion     what reproduces the post-operative clinical situationThe meditative data will be associated     with an anatomical biomechanical study of ankles presenting a syndesmosis injury repaired     according to the classic protocol using in our department, by comparing them with the data of     the literature to optimize techniques repair of this joint. Indeed there is not gold standard     surgical technique Main PurposeTo understand, observe, analyze and quantify the joint     movement during a simple movement of ankle extension and flexion, and during a simulation of     axial load miming walk fixed to 90 ° as in post-operative. Secondary purpose - Modelling the     DTFJ- Modify the post-operative care with hypothesis that load does not lead abnormal     movement in DTFJ with an ankle fixed to 90 ° ( post-operative clinical condition). - Validate     our technique of repair of this joint by comparing the data MRI with anatomical mechanical     tests   "
118330|NCT01737112|"     This is an open-label SPECT/CT (single photon emission computed tomography / computed     tomography) study to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in     evaluation of lung cancer patients. A single dose of nearly 11.1 MBq/kg body weight of     99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion     of lung cancer. Visual and semiquantitative method will be used to assess the whole-body     planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.   "
118331|NCT01737099|"     The purpose of this study is to investigate the efficacy and safety of DHA-O to lower     elevated triglyceride levels in healthy adults with hypertriglyceridemia.   "
118332|NCT01737086|"     Oral rehydration solution (ORS) is recommended for treatment and prevention of dehydration     due to acute gastroenteritis in infants and children. Acute diarrhoea leads to zinc depletion     in infants, and zinc is recommended by the World Health Organization in the treatment of     acute gastroenteritis in infants and children. However, the efficacy of zinc supplementation     to children with acute gastroenteritis in more affluent settings is unclear. Selected strains     of probiotics, including L. reuteri ATCC 55730, have been shown in several studies to shorten     the duration of diarrhoea by about 24 hours, and also to attenuate symptom severity. If     probiotics are given within 60 hours from onset of symptoms the duration can be reduced even     more. Lactobacillus reuteri (L. reuteri) has been shown to reduce the duration and severity     of acute gastroenteritis in children aged 6-36 months. In these studies L. reuteri was proven     to have clinical effect on diarrhoea of both bacterial and viral (rotavirus) origin. In     humans, L. reuteri strain DSM 17938 has recently been shown to reduce the duration of watery     diarrhoea by 1.2 days among 6-36 mo old Italian children with acute gastroenteritis treated     in hospital.      The present, community-based study aims to assess if an ORS with Lactobacillus reuteri DSM     17938 and zinc can be superior or equivalent to ORS without probiotic and zinc in reducing     the duration of acute gastroenteritis in children aged 6-36 months, with no, mild or moderate     dehydration when introduced early (within 48 hours) after the start of gastroenteritis     associated diarrhoea in an out-patient setting.      A prospective, randomized, double blind, controlled study with parallel groups will be     performed. Assuming a difference of 25% between groups in the primary outcome of prevalence     of diarrhoea 48 hours after start of treatment (80% power, alfa = 5%), and estimating an     attrition rate of approximately 15%, the final sample size will be 142 subjects, or 71     subjects in each arm.      Parents contacting the health care telephone enquiry agency, the primary care emergency unit,     the paediatric emergency unit, all at the Umeå University Hospital or the well-baby care     centres (BVC) in Umeå for advice on their children's gastroenteritis will be informed that     they may participate in the present study and they will be given contact information to the     research nurse for this activity. A home visit by study personnel will then be done for     evaluation of eligibility, information, collection of informed consent and delivery of study     product.      Data collection points will be at the recruitment visit in the patient's home, and by     telephone on day 7. If the child still has gastrointestinal symptoms on day 5 it will be     referred to the primary health care facility or the outpatient clinic of the Department of     Paediatrics, Umeå University Hospital.   "
118353|NCT01736813|"     The surface molecule CCR5 is found on tumor cells within liver metastases of colorectal     cancer. Inhibition of this molecule leads to a reduction in growth signals for tumor cells     and subsequent slowed or halted tumor growth. The agent for the inhibition of CCR5 has     already received FDA approval for treatment of HIV and has shown little side effects and     toxicities even on long term treatment. Therefore CCR5-inhibition has the potential of     providing non-toxic tumor growth inhibition.   "
118333|NCT01737073|"     This study will enroll Veterans with chronic pain who have been receiving opioid medications     (like methadone, percocet, oxycontin) on a regular basis for at least 3 months to treat their     pain. The purpose of this study is to understand if two automated interventions that are     delivered by phone can improve the safe and effective use of opioid medications and the     physical functioning of Veterans with chronic pain who take opioid medications. One     intervention, opioid monitoring, will include monthly automated calls to the enrolled Veteran     to ask questions about their use of the opioid medications, pain relief, side effects, effect     of pain on physical activity and mood and satisfaction with pain care. The other     intervention, skills training, includes learning pain management skills using automated calls     and a self-help book with weekly feedback calls from a nurse. Veterans who are enrolled in     this study will be randomly assigned (by chance, like a flip of a coin) to receive either     opioid monitoring only, self-management only, self-management plus opioid monitoring or a     weekly automated phone call with wellness tips. Everyone enrolled in the study will complete     questionnaires about their pain and other pain-related information at the beginning of the     trial, after the interventions are completed 12 weeks later, and 3 and 6 months after     treatment ends.   "
118334|NCT01737060|"     To investigate the assumption that reversed shoulder prosthetic replacement will give a     better functional outcome compared to open reduction and internal fixation with an angular     stable plate in displaced proximal humeral fractures.   "
118335|NCT01737047|"     The purpose of this study is to identify medical conditions that may cause particular     problems to individuals receiving care for HIV infection over the age of 50. In addition, as     the effects and potentially the side effects, of HIV medication may change with age, this     study will also investigate the association between age and differing effects of     antiretroviral therapies such as treatment outcomes, side effects and the levels of drugs in     blood.      Results from this study may inform future HIV treatment guidelines on how we monitor     individuals with HIV infection. The results may also assist in the design of future studies     for the treatment of diseases associated with ageing.   "
118336|NCT01737034|"     The catch-up fat phenomenon is an evolutionary conserved physiological response to a     starvationrefeeding cycle. It is characterized by long-term suppression of thermogenesis,     reduced body protein regain and an increase in fat mass above basal level during refeeding.     Clinically, it characterises weight cycling in overweight patients which is associated with     increasing fat mass (visceral fat) and increased morbidity (e.g. insulin resistance,     inflammation). In this project, the physiological, cellular and molecular mechanisms of this     phenomenon will be investigated in humans, mice and C. elegans. It is hypothesized that     refeeding a low GI (=glycemic index)- diet after weight loss prevents the catchup fat     phenomenon and its sequelae. This translational research will provide comprehensive insights     into the catch-up fat phenomenon as well as provide a suitable strategy of its prevention.   "
118337|NCT01737021|"     1. Evaluate the feasibility and acceptability of an information based intervention          delivered to parents following their child's admission to paediatric intensive care;        2. Evaluate the feasibility and acceptability of the study design and procedures;        3. Explore the effects of the intervention on parent and child psychological outcomes 3-6          months post discharge from PICU;        4. Explore the effects of parental stress experienced during PICU admission on the          effectiveness of the intervention;        5. To provide data that, combined with results from other studies, could inform the sample          size for a future multi-site RCT.   "
118338|NCT01737008|"     This is a phase 1 study of the drug dacomitinib with radiotherapy, with or without     chemotherapy, in patients with advanced squamous cell carcinoma of the head and neck (SCCHN).      Dacomitinib is an oral drug, which is found to be active in SCCHN patients, blocks a receptor     called the epidermal growth factor receptor (EGFR). By blocking signals for cancer cells to     grow, it is believed to stop or slow the growth of tumor cells.      The dose escalation phase will find the best dose as well as determine the safety of     dacomitinib when given with radiotherapy and with or without chemotherapy.The dose expansion     phase will further test the best dose determined in the dose escalation phase for response     rate.   "
118339|NCT01736995|"     Research has provided support for the efficacy of cognitive-behavioral and family     interventions for adolescent substance use disorders (SUD), HIV-risk behaviors, and related     problems. Despite support for these interventions, substantial heterogeneity in treatment     outcomes and high relapse rates has been consistently found across studies. Such variability     highlights the need for innovative strategies to broaden the impact and strengthen the     durability of effects of adolescent substance abuse treatments. Over the past two decades,     research has shown the positive effects of contingency management (CM) methods on reductions     in substance use and other problem behaviors. When combined with evidence-based practices,     emerging research suggests that CM integration may also be effective for adolescent substance     abusers. The proposed Stage II efficacy trial examines the integration of CM with two     empirically-supported interventions: group MET/CBT and FFT. By comparing two intervention     modalities (group vs. family, the study provides a unique opportunity to examine the     robustness of the effects of CM across established adolescent treatments, and to compare     change mechanisms that may account for treatment outcomes. In the proposed research,     substance abusing adolescents (n = 160) will be randomly assigned either to FFT or group     MET/CBT. Random assignment will also be used to determine whether or not youth will receive a     CM condition that provides incentives for abstinence (i.e., clean urine screens) and     treatment participation. The primary aim of the study is to examine the efficacy of an     integrated CM intervention for the two evidence-based treatments for adolescents, MET/CBT and     FFT, compared to these treatments without CM on drug abuse abstinence (a) during treatment     (i.e., speed of effects) and (b) at post-treatment follow-up assessments (i.e., durability of     effects). A second aim of the study is to evaluate the effects of CM on hypothesized     mediators of the intervention effects in the MET/CBT and the FFT conditions. The     investigators anticipate that the CM conditions, compared to the nonCM conditions, are more     likely to accelerate the adolescent's motivation (1) to achieve abstinence, to attend and     participate in treatment, and to complete homework assignments. The investigators will also     examine the effects of the interventions on HIV-risk behaviors and expect that CM will     demonstrate the largest reductions in HIV-risk behaviors compared to the nonCM conditions.   "
118354|NCT01736800|"     The specific purpose of this study is to obtain data on safety and efficacy of combination     chemotherapy with Temozolomide and Topotecan in patients with CNS metastases of solid tumors.     Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years and will     receive 8 cycles of chemotherapy. The primary endpoint is the determinant median overall     survival and progression-free survival of this regimen, time to progression of the brain     metastases, and assessment of toxicity levels in this regimen.   "
118355|NCT01736787|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of     immunity. The investigators measured promotion of immunity parameters , including     Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH,     MCHC, PLT), and monitored their blood pressure.   "
132487|NCT01550822|"     This lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise,     and smoking cessation) among stroke survivors and result in a reduction in measures of     general and abdominal obesity.   "
118340|NCT01736982|"     Smoking cessation services are an unmet need among the homeless, who smoke at rates more than     3 times the national estimate; successful interventions in this underserved population have     the potential for improving individual and public health. Contingency management (CM) is a     behavioral intervention with efficacy in a number of substance use disorder populations,     including smokers. However, no known studies have evaluated the effect of CM in homeless     smokers. The investigators plan to examine smoking-related outcomes in homeless     treatment-seeking smokers (N = 70) randomized to standard care smoking cessation (transdermal     nicotine replacement therapy [NRT] + standard counseling + carbon monoxide [CO] monitoring)     or standard care plus CM (NRT + standard counseling + CO monitoring + CM) conditions.     Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT use     continuing through week 8. Participants in both conditions will meet with study staff up to     twice daily on weekdays for biochemical verification of smoking status. Participants in the     CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤ 4     ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The     investigators expect that participants randomized to CM will have better outcomes compared to     those in standard care.   "
118341|NCT01736969|"     The purpose of this study is to determine whether a developmental formulation is     substantially equivalent to the predicate device in the treatment of hypertrophic and keloid     scars.   "
118342|NCT01736956|"     For fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve     fetal growth of left heart structures and thus improve potential for biventricular repair     strategies after birth.   "
118343|NCT01736943|"     The purpose of this study is to determine whether bortezomib in combination with     doxil/lipodox is effective in the treatment of Acute Myeloid Leukemia.   "
118344|NCT01736930|"     The purpose of this study is to evaluate an overnight system that will turn off the insulin     pump automatically if the system predicts that a low blood sugar is likely. The study system     includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic     MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low     blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous     glucose monitor, (2) using a computer program on a laptop to predict what will happen to the     glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the     computer program predicts that low blood sugar will occur. We have tested this system     overnight in the hospital and are ready to test the system in the home environment to learn     more about how well it will work and to make sure that the blood sugar does not go too high     when the pump shuts off.      This study has several phases and will take about a month or a little more for a patient to     complete. Patients will use the study system for about 5 days at home to show that the     patient is able to use it correctly. After that, the patient will be asked to use the study     system each night for an additional 3-4 weeks. During this time, the system will be active     for two-thirds of the nights and not active for one-third of the nights. When the system is     active and predicts that your blood sugar will become low, the insulin pump will shut off for     up to 2 hours.      The study will include 2 clinical centers in the United States.   "
118345|NCT01736917|"     The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV     fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will     provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting,     compared to the results of our prior study of aprepitant. This study will be the first     clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin. This will     be a single arm, phase II study. The investigators propose to utilize intravenous (IV)     fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is anticipated     that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for 2-5 days after     therapy. This study will test the value of fosaprepitant in this patient population.   "
118346|NCT01736904|"     The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in     the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of     wXELIRI is not less than FOLFIRI with tolerable toxicity.   "
118347|NCT01736891|"     The objective of this study is to evaluate the efficacy, tolerability, and safety of     rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.   "
118348|NCT01736878|"     The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo     in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective     is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the     placebo treatment group in patients with advanced MTC.   "
118349|NCT01736865|"     This research study in adults with established type 2 diabetes will test whether daily     vitamin D supplementation affects how the body processes glucose (sugar).   "
118350|NCT01736852|"     The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening     Balloon (CRB) for the induction of labor in term and near-term patients with premature     rupture of membranes (PROM).   "
118351|NCT01736839|"     In cystic fibrosis, there is a critical need for better predictors of treatment response. The     investigators have identified a panel of white blood cell biomarkers which can be directly     measured as a blood test in subjects with cystic fibrosis. These biomarkers predict reduction     of airway inflammation and infection more accurately than lung function testing, in patients     receiving intravenous antibiotic therapy. In the current study, we hypothesize that this     panel of gene biomarkers which can be readily measured from peripheral blood will sensitively     predict changes in inflammation when patients receive inhaled antibiotic therapy,     specifically Cayston (or inhaled aztreonam lysine). Patients enrolled in the study will have     blood drawn before and after a month of inhaled Cayston, in order to test whether genes     predict response to Cayston therapy more robustly than do standard measures such as lung     function tests.   "
118352|NCT01736826|"     The primary objective of this study is to demonstrate that plasma concentrations of     nucleosomes and free DNA differ between three groups:        1. pregnant patients with complications typical of placental insufficiency or venous          thrombosis (group P),        2. healthy women (Group T1) and        3. healthy pregnant women (Group T2).   "
118367|NCT01736631|"     We are doing this study to find out how well cognitive behavioural therapy for social phobia     works in people with bipolar disorder, who also have social phobia.   "
118356|NCT01736774|"     The presence of cervical musculoskeletal impairment is not specific to cervicogenic headache     but other various frequent intermittent headache types (i.e. migraine and tension-type     headache) in the elderly population. There has been no trial to date which has investigated     the effectiveness of physiotherapy treatment specifically for older persons with various     types of headache with associated neck pain and cervical musculoskeletal impairment. Thus,     the purpose of study investigate the efficacy of physiotherapy treatment for older persons     who have headache concomitant with neck pain and musculoskeletal impairment   "
118357|NCT01736761|"     For patients who are starting to take antiretroviral medication (to treat HIV) for the first     time, there are now a variety of different medicines which may be taken together as a     combination in order to form an effective treatment which suppresses the virus for prolonged     periods of time. Currently, national guidelines recommend the use of two different drugs of     one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as     nukes) with a third drug from one of two other types (either a nonnucleoside reverse     transcriptase inhibitor, known as an NNRTI or nonnuke, or a protease inhibitor, known as a     PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are given     in combination with a small dose of a second PI, ritonavir, which has the effect of boosting     the levels of the active PI in the bloodstream.      The investigators know from both research studies and patient experience in clinic that a     combination of a ritonavirboosted PI with an NNRTI achieves similar results in suppressing     the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above. In     this study, the investigators will observe the combination of two licensed antiretroviral     medications, ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV), in suppressing virus     when given to patients who are commencing treatment for HIV infection for the first time.     Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe, and     are currently in standard clinical use.      The study will monitor this treatment over the first 48 weeks. The investigators will also     examine the levels of both drugs in the bloodstream during the first 4 weeks of starting this     regimen, to confirm that they remain at levels which the investigators know to be effective     against the virus.   "
118358|NCT01736748|"     The Dyn@mo lifestyle intervention (CHU Sainte-Justine, Quebec, Canada) targets children and     adolescents aged 6 to 17 years old with cardiometabolic risk factors, such as obesity,     hypertension, disorders in glucose regulation or dyslipidemia. Its primary goal is to promote     physical activity and reduce sedentary time to improve childrens' cardiometabolic profile. To     do so, the intervention relies on gathering data on mobility and physical activity using     wearable sensors. These data provide a detailed picture of real-life conditions and physical     activity levels, improving the health care professional's ability to tailor counseling. The     investigators are presently in the implementation phase of this intervention.   "
118359|NCT01736735|"     This is a placebo-controlled study to determine the effect of CLP in heart failure subjects     with fluid overload.   "
118360|NCT01736722|"     The Methodist Hospital Neurological Institute is conducting a clinical trial for patients     suffering from Metastatic brain tumors. The objective for this study is to evaluate the     safety and feasibility of a MRI-guided laser thermal therapy during a real-time MRI guidance     for the treatment of brain metastasis.      Patient will undergo laser therapy using the MRI scan to plan the treatment and ensure proper     placement of the laser within the tumor. The tumor will then be heated by the laser and     monitored by study physicians through the real-time MRI to see and control temperatures in     the tissue. One in place, the thermal laser will then surgically remove the lesions. After     the procedure, post treatment MR images will thenbe acquired for the determination of the     effective treatment region.   "
118361|NCT01736709|"     The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent     seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged     18-60 years old, and 60 healthy older people aged > 60 years.   "
118362|NCT01736696|"     This study was conducted in subjects with psoriasis to evaluate drug activity in this patient     population by analysis of changes in psoriatic lesion biopsy characteristics. This subject     population was selected to evaluate potentially relevant biological activity of CP-690,550 as     well as assessing safety and pharmacokinetics.   "
118363|NCT01736683|"     The primary objective of this study is to determine a safe, tolerable and effective dose of     sotatercept that results in the greatest frequency of improvement of anemia in patients     diagnosed with low- or intermediate-1 risk MDS or non-proliferative chronic myelomonocytic     leukemia (CMML).   "
118364|NCT01736670|"     Triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available     in a spray formulation (Triamcinolone Acetonide Spray, T Spray). It is indicated for the     relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.     Unlike more potent steroid products, T Spray has no time limitations on its use; therefore,     it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis,     and contact dermatitis.      In contrast to creams and ointments, T Spray can easily cover large and hard-to-reach areas     of the body. Its optional nozzle directs application of the medication to precise areas     without affecting nearby areas. Patients requiring a mid-potency corticosteroid for lesions     on the scalp, back, intertriginous folds, large areas, or areas that require precise     application would benefit from the T Spray formulation. In the time since the introduction of     T Spray to dermatology, other topical corticosteroids have entered the market, but T Spray     remains the only mid-potency corticosteroid available in a spray formulation.      In a recently published open-label, non-comparator study involving 42 patients with chronic     steroid-responsive dermatoses, T Spray was used up to four times a day for 28 days.     Improvement of lesions after one week of treatment was experienced by 85% of patients, and     95% of subjects preferred the spray over creams and ointment. Most importantly, 56% of     patients reported an anti-pruritic cooling effect which was experienced upon application.   "
118365|NCT01736657|"     The purpose of this study is to evaluate the performance of the Spectra Optia system red     blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants     with sickle cell disease.   "
118366|NCT01736644|"     This study will compare the clinical outcomes for patients undergoing a total knee     replacement using a bipolar sealer, the Aquamantys® System, as compared to standard     electrocautery. Total blood loss during the hospital stay and knee mobility and discharge     factors will be analyzed.   "
118369|NCT01736605|"     In this study we propose to explore the efficacy of massage therapy combined with meditation     in women recovering from tissue reconstruction after mastectomy for breast cancer. Patients     will be randomized into 2 groups. The first group will consist of massage therapy on 3     consecutive days starting on the 1st day after surgery. The second group will consist of     massage therapy combined with meditation for 3 consecutive days starting on the 1st day after     surgery. The effect of massage and massage combined with meditation on stress, anxiety,     relaxation, insomnia, alertness, fatigue, tension/muscular discomfort, pain, mood and energy     level will be evaluated by using three different surveys.   "
118370|NCT01736592|"     The purpose of the study is to examine the long term safety of an experimental gene transfer     agent, SAR422459, designed to treat Stargardt Macular Degeneration.   "
118371|NCT01736579|"     The purpose of this long-term study is to provide additional evidence of safety and efficacy     of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase     3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg     or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701.     Participants and investigators will be blinded to dose unless otherwise notified by the     sponsor.   "
118372|NCT01736566|"     The MedSeq™ Project seeks to explore the impact of incorporating information from a patient's     whole genome sequence into the practice of clinical medicine. In the extension phase of     MedSeq we are attempting increase our participant diversity by increasing targeted enrollment     of African/African American patient participants.   "
118373|NCT01736553|"     Spinal muscular atrophy (SMA) is the leading genetic cause of death of infants. Strong     preclinical evidence suggests that effective therapy must be delivered as early as possible     to prevent progression of the disease. The primary study objective will be to identify     prognostic and surrogate biomarkers of disease progression that will facilitate the execution     of therapeutic SMA clinical trials in infants.   "
118374|NCT01736540|"     Iron, one of the most common elements in nature and the most abundant transition metal in the     body, is readily capable of accepting and donating electrons. This capability makes iron a     useful component of various, essential biochemical processes. Despite the essential role of     iron, the excess of iron is toxic to the human body. It is critical for the human body to     maintain iron balance, since humans have no physiologic mechanism for actively removing iron     from the body.      The development of iron overload occurs when iron intake exceeds the body's capacity to     safely store the iron in the liver, which is the primary store for iron. Long-term     transfusion therapy, a life-giving treatment for patients with intractable chronic anemia is     currently the most frequent cause of secondary iron overload.      The mounting evidence regarding the mortality and morbidity due to chronic iron overload in     transfusion dependent anaemias has led to the establishment of guidelines that aim the     improvement of patient outcomes. Further prospective studies are warranted in order to assess     the impact of iron overload in patients with acquired anaemias.      In this study, non-invasive R2- and T2*-MRI techniques were applied to the liver and the     heart, respectively, to complement the primary variable (serum ferritin) assessed in patients     with various transfusion-dependent anaemias. The main objective of this study was to assess     the prevalence and severity of cardiac and liver siderosis in patients with transfusional     siderosis. This study was also aim to establish possible correlations between cardiac and     liver iron levels with clinical effects in patients with different transfusion-dependent     anaemias. Patients were eligible for enrollment irrespective of receiving chelation therapy     or not (and irrespective of the chelating agent used).   "
118375|NCT01736527|"     To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical     instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.   "
118376|NCT01736514|"     This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study.     Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or     allopurinol for subjects with gout.   "
118377|NCT01736501|"     A 10 minute baseline survey will be administered to parents of healthy newborn infants while     in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25 minute     survey 3-24 months later. We will measure parents' attitudes and preferences related to     genome screening of newborns. The specific aims of this study are:        1. To investigate whether parents' opinions regarding genome screening of newborns change          between the first 48 hours post-partum and 3-24 months post-partum.           a. We hypothesize that there will not be significant differences between interest in          genome screening results in the 48 hours post-partum compared to 3-24 months          post-partum.        2. To determine whether seeing hypothetical genome screening results affects parents'          decisions regarding whether they would want genome screening for their newborn.             1. We expect many parents to state initially (in the 48 hours post-partum) that they               would elect to have genome screening for their newborn if it were available. In the               follow-up survey, half of study participants will receive hypothetical scenarios in               which they will need to struggle with the probabilistic and ambiguous nature of the               information that could be derived from genome sequencing. We will examine whether               this alters their preferences. We will also explore whether parents who receive               hypothetical genome screening results scenarios are more likely to alter their               preferences than parents who do not receive hypothetical scenarios.   "
118378|NCT01736488|"     The purpose of this study is to evaluate the antihypertensive efficacy and changes of     neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response     during exercise in essential hypertensive patients.   "
118379|NCT01736475|"     To assess efficacy and safety, including immunogenicity of BAX 855 administered as     prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated     patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of     BAX 855.   "
118380|NCT01736462|"     The objective of this study is to evaluate the effect on corneal endothelial cell density     (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered QID     (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.   "
119899|NCT01716533|"     This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and     2) explore the difference in immune response between the patients with CDI recurrence and     those with a sustained clinical response.   "
118381|NCT01736449|"     A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the     surface of the cornea. Frequently, these pterygia will recur even after surgical resection.     Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use of     bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this study     is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab     versus pterygium excision alone.   "
118382|NCT01736436|"     It has been shown in preclinical experiments with bone marrow from patients with     myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is     expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients.      APG101 might, therefore, be a valuable addition to current treatments of low- or intermediate     MDS patients suffering from anaemia.      Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic     Scoring Scale (WPSS) can be included in this study.      Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6 months     follow up phase.      Primary objective of the trial is safety and tolerability of APG101; secondary objectives are        -  Hematologic, cytologic and cytogenetic response rate using modified International          Working Group (IWG) response criteria        -  Incidence and time to leukemic progression at 37 weeks        -  OS (Overall survival) at 37 weeks   "
118383|NCT01736423|"     To evaluate the efficacy and safety of YM060 once daily for female patients with     diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52     weeks).   "
118384|NCT01736410|"     To explore overall response rate of trastuzumab combined with TS-ONE based chemotherapy in     first-line HER2-positive advanced gastric cancer.   "
118385|NCT01736397|"     The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and     effective treatment for the management of serum phosphorus levels and iron deficiency in     anemic chronic kidney disease (CKD) subjects not on dialysis. Total length of treatment is     approximately 12 weeks.   "
118386|NCT01736384|"     There is a variability in weight loss after gastric bypass surgery for obesity despite a     standardised surgical procedure. This study aims to investigate if genetic markers can     predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will     also study if adenovirus infection can influence the outcome after surgery. In a subgroup of     patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein     patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as     liver biopsies and whole blood are stored in a biobank. The same tissues will be collected     from non-obese controls undergoing gallbladder surgery.   "
118387|NCT01736371|"     The aim in this study was to quantify the difference in cisatracurium and sufentanil     consumption, and its recovery period, when patients are under balanced general anesthesia     with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed     loop computer control infusion. Investigators further investigated this effect on its     recovery period and sufentanyl consumption.   "
118388|NCT01736358|"     Despite an overall reduction in the perioperative complication rate, post operative pain     management after ureteroscopic removal of stones (URS) remains a major factor delaying     discharge of patients. The investigators hypothesize that perioperative usage of intranasal     ketorolac will provide a reduction in post operative opioid requirements, better post     operative pain control, higher anesthesia satisfaction and faster recovery.   "
118389|NCT01736345|"     The overall goal of the proposed research is to evaluate psychosocial and behavioral outcomes     (i.e.risks and benefits) of an innovative and efficient delivery model for genetic testing,     telephone communication, as an alternative to in-person communication of genetic testing     results to inform guidelines regarding the delivery of genetic information in clinical     medicine.   "
118390|NCT01736332|"     Background:      - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as     poppy seeds) may cause a positive screening drug test. This might look like someone used     illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are     studying how the body handles chemicals that may test like illegal drugs and for how long     they may be detected in the body. Blood, saliva, and urine samples will be collected. This     study may help improve the effectiveness and accuracy of drug tests.      Objectives:      - To see how the body handles chemicals that may produce positive screening tests and how     additional testing can eliminate positive drug tests from over-the-counter drugs and food.      Eligibility:      - Healthy volunteers between 18 and 65 years of age.      Design:        -  Participants are screened with a physical exam, medical history, laboratory tests, and          ECG.        -  This study involves an overnight stay on a secure research unit and 2 days of tests.        -  On the first day, participants will take Vicks VapoInhaler (two inhalations in each          nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing          poppy seeds twice (at about 9 a.m. and 5 p.m.).        -  On the morning of the second day, participants will take the Vicks VapoInhaler just          once. They will be discharged around 5 p.m.        -  On both days, participants will provide blood and saliva samples several times          throughout the day. All of their urine will be collected during the 2 study days.   "
118391|NCT01736319|"     Background:      - Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria.     ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is     becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of     Cambodia, but not yet in other parts of the country. This has been shown by treating patients     with ACTs, checking the amount of parasites in the patient s blood every 6 hours, and     calculating the rate of parasite clearance. The parasite clearance rate in response to ACTs     is getting slower in western Cambodia and may be the first sign of ACT resistance.     Researchers want to study how effective ACTs are in different regions of Cambodia. This study     will look at the extent of ACT resistance and how widespread ACT-resistant malaria has     become.      Objectives:      - To compare the prevalence of ACT-resistant malaria in western, northern and eastern     Cambodia.      Eligibility:      - Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum     malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days.      Design:        -  Participants will be recruited from clinics and hospitals in three Cambodian provinces.        -  Participants will be informed about the study and their consent to participate in the          study will be obtained.        -  A venous blood sample will be obtained from patients before treatment and used for          laboratory experiments to measure parasite and patient factors that might affect the          parasite clearance rate.        -  Participants with malaria will be treated with dihydroartemisinin-piperaquine (DHA-PPQ),          the standard first-line treatment for malaria in Cambodia.        -  Treatment will be monitored with frequent blood samples obtained from a finger prick.          The amount of malaria parasites in each blood sample will be counted and followed until          they are no longer detectable.        -  Participants will have weekly follow-up visits for up to 9 weeks. Finger-prick blood          samples will be taken at each visit to see if the parasites reappear after treatment          with ACT.   "
132488|NCT01550809|"     Achieving near-normoglycemia has been established as the main objective for most patients     with type 1 diabetes (T1DM). However, insulin dosing is an empirical process and its success     is highly dependent on the patients' and physicians' skills, either with multiple daily     injections (MDI) or with continuous subcutaneous insulin infusion (CSII, the gold standard of     insulin treatment).      Postprandial glucose control is one of the most challenging issues in the everyday diabetes     care. Indeed, postprandial glucose excursions are the major contributors to plasma glucose     (PG) variability of subjects with (T1DM) and the poor reproducibility of postprandial glucose     response is burdensome for both patients and healthcare professionals.      During the past 10-15 years, there has been an exponentially increasing intrusion of     technology into diabetes care with the expectation of making life easier for patients with     diabetes. Some tools have been developed to aid patients in the prandial bolus     decision-making process, i.e. bolus advisors, which have been implemented in insulin pumps     and more recently in the newest generations of glucometers. Currently, the availability of     continuous glucose monitoring (CGM) has opened new scenarios for improving glycemic control     and increasing understanding of post-prandial glycemic response in patients with diabetes.      Results from clinical studies suggest that sensor-augmented pumps (SAP)may be effective in     improving metabolic control, especially when included as part of structured educational     programs resulting in patients' empowerment. Similarly, preliminary results from pilot     studies indicate that automated glycemic control, especially during nighttime,based on     information from CGM is feasible. However, automatic management of meal bolus is currently     one of the main challenges found in clinical validations of the few existing prototypes of an     artificial pancreas. Indeed, fully closed-loop systems where information about meals size and     timing is not given to the system have shown poor performance, with postprandial glucose     higher and post meal nadir glucose lower than desired. This has promoted other less-ambitious     approaches, where prandial insulin is administered following meal announcement (semi     closed-loop). However, despite the use of meal announcement, currently used algorithms for     glucose control (the so-called PID and MPC), show results that are not yet satisfactory due     to the risk of producing hypoglycemia.      One of the limitations of the current open-loop (bolus advisors) and closed-loop control     strategies is that glycemic variability is not taken into account. As an example, settings of     CSII consider inter-individual variation of the parameters (insulin/carbohydrates ratio,     correction dose, etc.) but disregard the day-to-day intra-individual variability of     postprandial glucose response. Availability of massive amount of information from CGM,     together with mathematic tools, may allow for the characterization of the individual     variability and the development of strategies to cope with the uncertainty of the glycemic     response to a meal.      In this project, a rigorous clinical testing of a CGM-based, user-independent algorithm for     prandial insulin administration will be carried out in type 1 diabetic patients treated with     insulin CSII.      First of all, an individual patient's model characterizing a 5-hour postprandial period will     be obtained from a 6-day CGM period. The model will account for a 20% uncertainty in insulin     sensitivity and 10% variability in the estimation of the ingested carbohydrates. Based on     this model (derived from CGM), a mealtime insulin dose will be calculated (referred as     iBolus). Then, the same subjects will undergo standardized meal test studies comparing the     administration of a traditional bolus (tBolus, based on insulin to CHO ratio, correction     factor, etc.) with the CGM-based prandial insulin delivery (iBolus).      Significant advances in postprandial control are expected. Should its efficiency be     demonstrated clinically, the method could be incorporated in advanced sensor augmented pumps     as well as feedforward action in closed-loop control algorithms for the artificial pancreas,     in future work.   "
118392|NCT01736306|"     Background:      - At present, women do not have very accurate tests to inform of them of their personal risk     of developing breast cancer. More information on the changes associated with both benign and     cancerous breast lesions will help develop better risk information. Researchers have been     looking at cells found in breast milk to study genetic changes related to breast cancer.     However, most of these cell samples have been collected from white women. A new study wants     to collect breast milk samples from African American women for further research. Comparing     the results of genetic tests will help improve understanding of breast cancer risk in all     women.      Objectives:      - To study genetic changes related to breast lesions, including breast cancer, in African     American women.      Eligibility:      - African American women at least 18 years of age who are nursing a baby and who either have     had or are being considered for a breast biopsy.      Design:        -  Participants will be screened with personal health questions.        -  Participants will receive a box with sterile bottles for milk collection. They will          collect two breast milk samples, one from each breast. They will also fill out a          questionnaire about their medical history.        -  The box with the samples and the questionnaire will be returned to the clinical center          for study.        -  After the box is returned, participants will be asked to provide a copy of the biopsy          report for any breast biopsies they have had.        -  There will be a followup phone call every year. Participants will provide health history          information. This information will include whether they have been diagnosed with breast          cancer in the previous year.   "
118394|NCT01736280|"     Background:      - Some research studies focus on digestive disorders, such as nutritional, gastrointestinal,     and liver disorders. Researchers want to examine and treat people with digestive disorders in     order to learn more about these disorders. They also want to study how digestive disorders     run in some families. To do so, they will provide standard care to people with digestive     disorders. They will also look at relatives of people with digestive disorders, such as     parents, children, and siblings.      Objectives:        -  To examine and treat people with digestive disorders.        -  To evaluate people with digestive disorders for research studies.      Eligibility:        -  Individuals of any age who have digestive disorders.        -  Individuals at least 2 years of age who are first-degree relatives of the people with          digestive disorders.      Design:        -  Participants will have at least one outpatient visit to the National Institutes of          Health. The visit will last about 2 hours.        -  All participants will be screened with a physical exam and medical history. They will          also provide different samples for study. Samples may include blood, urine, and stool          samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may          be collected from adult participants.        -  Participants with digestive disorders may be able to receive treatment through this          study.   "
118395|NCT01736267|"     The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI)     can improve hearing in persons who are deaf in both ears and are not candidates for cochlear     implants.   "
118396|NCT01736254|"     The purpose of this study is to measure how much of the study drug (evacetrapib) gets into     the blood stream and how long it takes the body to get rid of it when given with gemfibrozil.     Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in     combination. There is no washout period between doses. The safety of both of the study drugs     given together will be evaluated. Information about any side effects that may occur will also     be collected. This study will last approximately 36 days.   "
118397|NCT01736241|"     The main purpose of this study is to evaluate the safety and tolerability of the study drug     known as LY3053102 in healthy participants. The study will also investigate how much of the     study drug gets into the blood stream and how long it takes the body to get rid of it.     Information about any side effects that may occur will also be collected. The study is     expected to last approximately 8 weeks for each participant (up to 4 weeks from the screening     visit to the administration of study drug and an additional 4 weeks of follow up).   "
118398|NCT01736228|"     The purpose of this study is to establish the efficacy and safety of xenotransplantation of     DIABECELL [immunoprotected (alginate-encapsulated) porcine islets] in patients with     established type 1 diabetes mellitus   "
118399|NCT01736215|"     The purpose of this observational study is to evaluate the predictors of response to     erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone     marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the     body until it kills) related anemia (decreased number of red blood cells), receiving     chemotherapy (treatment of cancer using drugs).   "
118400|NCT01736202|"     The development of type 2 diabetes is based on a combination of insulin resistance and beta     cell dysfunction. In the last years, elevated FFA were recognized as a key players in the     pathogenesis of insulin resistance and type 2 diabetes.      The study compares the acute effects of an oral lipid bolus on insulin sensitivity and     hepatic glucose metabolism in healthy humans.   "
118401|NCT01736189|"     In the usual clinical setting, patients with Rheumatoid Arthritis who receive adalimumab     (Humira®) and high-dose Methotrexate (≥12 mg/week) will be investigated prospectively for     effectiveness according to Disease Activity Score 28, modified Total Sharp Score, and other     measures, as well as safety in terms of the incidence and pattern of occurrence of adverse     drug reactions.   "
118406|NCT01736124|"     Computerized cognitive training (CCT) is an intervention has improved cognitive functioning     in the elderly with and without cognitive impairment. The investigators will study the effect     of a CCT program over an active control, classic computerized games. The outcomes will be     memory and executive functions/attention, diabetes elf-management and adherence to     medications, and glycemic and blood pressure control. Non-demented elderly Veterans with     diabetes mellitus, who are at high risk for cognitive impairment, will be from the James J.     Peters, Bronx, NY and Ann Arbor, MI VAMCs. This novel potential service fits the portfolio of     the Quality Enhancement Research Initiative for Diabetes Mellitus (QUERI-DM) for which the     Ann Arbor VAMC is a primary center. If successful, the VA National Center for Prevention and     MyHeatheVet will collaborate in disseminating results to encourage implementation throughout     the VA   "
118418|NCT01735968|"     The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2     dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.   "
118407|NCT01736111|"     Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled     in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive     usual medical care, printed materials, and educational text messages. The INTERVENTION group     will also receive personalized coaching and feedback, as well as peer support, via text     message.      The investigators hypothesize that compared to those in the Control group, patients in the     Intervention group will lose more weight and demonstrate more favorable changes in fruit and     vegetable intake, exercise, and social support for weight loss.   "
118408|NCT01736098|"     The focus of this randomized clinical trial study is an examination of the effects of     maintaining energy balance at different energy fluxes. It will address the primary question:     Are there increased health benefits related to body composition and metabolic function     associated with maintaining energy balance at a high energy flux as compared to a low energy     flux?   "
118409|NCT01736085|"     The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling     condition) randomized trial to test the provision of nicotine patches to help smokers calling     a telephone quitline. The study assesses one factor related to nicotine patches with 3     levels: sending patches directly from the Helpline, providing vouchers that can be redeemed     for patches, and usual care. A second factor is counseling plus materials versus materials     only. This proposed study has the following specific aims:        1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for          smokers who do not have access to free nicotine replacement therapy (NRT)        2. To demonstrate that sending patches directly from a quitline would outperform sending          vouchers for free NRT, since the vouchers impose an additional barrier to those who want          to quit        3. To determine the effect of telephone counseling in the context of nicotine patch          distribution and if any interaction effects exist between counseling and patch          conditions   "
118410|NCT01736072|"     The purpose of this study is to compare two different surgical procedures for the treatment     of Rectal Cancer: Laparoscopic Surgery and Robotic Assisted Laparoscopic Surgery. The ROLARR     study is for participants with cancer of the rectum for whom a laparoscopic operation     (sometimes called keyhole surgery) has been recommended by their surgeon.      In the past most rectal cancers were removed using open surgery. Open surgery involves a     large cut down the middle of the patient's abdomen to allow the surgeon to see and take out     the cancer. On a previous study showed that using laparoscopic surgery to remove colorectal     cancers was as good as open surgery for curing cancer.      There is now another option to remove rectal cancers, which involves using a robotic system     with laparoscopic surgery. This type of surgery is called robotic-assisted laparoscopic     surgery and is now becoming widely used by surgeons to remove cancers including the rectum,     as well as for other non-cancer operations.      In order to perform robotic-assisted laparoscopic surgery, the surgeon sits at a robotic     control unit a few feet away from the patient. Using the robotic control unit, the surgeon     can see a clear video image of the patient's abdomen and the operation site. The surgeon can     perform the operation from the robotic control unit by controlling the movement of a set of     robotic surgical instruments, guided by the video camera.      Like standard laparoscopic surgery, the surgeon is able to carry out the entire operation     through a few small cuts in the abdomen. The camera of the robotic system provides a 3D     high-definition magnified view of the operation site and the robotic system is also able to     translate the movements of the surgeon's hands into small precise movements inside the     patient's body.      We want to test whether robotic-assisted laparoscopic surgery is as good, or even better, at     removing rectal cancers as standard laparoscopic surgery (actually Robotic-assisted     laparoscopic surgery is used as standard of care in rectal cancer patients at University of     California, Irvine Medical Center). We also want to investigate whether using     robotic-assisted laparoscopic surgery reduces the number of times a laparoscopic operation     needs to be converted to an open operation, and see whether using a robotic system can also     shorten the length of time patients need to stay in hospital and if it reduces the number of     complications patients may have during and after their operation.   "
118411|NCT01736059|"     This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem     cells from bone marrow into the eye as treatment for patients who are irreversibly blind from     various retinal conditions.   "
118412|NCT01736046|"     The investigators will be assessing the efficacy of a Model Based Iterative Reconstruction     algorithm (MBIR) as a noise reduction tool in computed tomographic (CT) examinations for     Crohn's Disease. MBIR is computer adapted mathematical calculation technique that generates     CT images with less picture degradation (noise) than traditional computer reconstruction     techniques such as FBP (Filtered Back Projection) and ASIR (Adaptive Statistical Iterative     Reconstruction), for enteric Crohn's Disease findings.      The research involves collection of data from subjects standard of care diagnostic CT scan     and from a research low radiation dose scan performed immediately following their diagnostic     scan. We will determine the impact on image quality, interpretability, and Crohn's Disease     findings of the low dose scan compared to the standard of care scan.      FBP, MBIR, and ASIR are post processing tools that do not alter the scan acquisition itself.   "
118413|NCT01736033|"     The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy     and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate     hyperplasia patients, and suggest guidelines of the combination therapy.   "
118414|NCT01736020|"     This preclinical phase 1 development study in healthy volunteers seeks to identify if low     doses of commonly used non-triggering anesthetic agents might have clinical utility for     modulating emotional memory processing and to understand the nature of the brain mechanisms     of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that     will form the foundation for future use in clinical studies of patients with PTSD.   "
118415|NCT01736007|"     Alopecia Areata (AA) is a skin restricted autoimmune disease of the hair follicle, resulting     in hair loss of the scalp, and in severe cases of the entire body. AA is the second most     common cause of alopecia in childhood; no FDA-approved treatments exist. The use of focused     narrow-band ultraviolet-B light via the excimer laser is a common treatment for many skin     diseases in patients of all ages. In this study, the feasibility of the 308-nm excimer laser     for treatment of patch type AA of the scalp will be examined. We anticipate the excimer laser     will be safe and a feasible option for patients with patch type AA. The excimer laser may     represent a novel treatment for childhood AA and no comparison or large studies currently     exist in the literature.      Hypotheses The 308-nm excimer laser procedure is a feasible, well-tolerated and safe     treatment for patch type alopecia areata of the scalp in children.   "
118416|NCT01735994|"     Given the cost of treating eating disorders and the substantial morbidity and mortality     associated with these disorders, prevention of eating disorders has considerable public     health significance. Female athletes represent an important population for prevention due to     their risk for the Female Athlete Triad, which includes inadequate energy intake, irregular     or cessation of menses, and osteoporosis. The proposed randomized controlled trial will     provide important information regarding the efficacy, acceptability, and feasibility of     implementing a brief eating disorder prevention and healthy living program within an existing     social system of female athletes.   "
118417|NCT01735981|"     To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise     modality to improve gait and balance in individuals with Huntington's disease.   "
118419|NCT01735955|"     The purpose of this study is to allow continued use of nilotinib in patients who are on     nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs     (CD&MA) study and are benefiting from the treatment as judged by the investigator   "
118420|NCT01735942|"     The purpose of this study is to find out the effectiveness of ingenol mebutate compared to     cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.   "
118421|NCT01735929|"     The purpose of this study is to find out the effectiveness of ultrasound treatment and     liposuction combined on skin tightening around the neck.   "
118422|NCT01735916|"     This study is looking at whether the electrical treatment provided by a special type of     pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's     heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are     electrically paced to beat together by the CRT pacemaker, blood may be pumped to the body     more efficiently.      The CRT pacemaker being studied in this clinical trial is approved by the US Food and Drug     Administration (FDA) for patients with moderate to severe heart failure, whose hearts pump     blood inefficiently. In the MIRACLE EF study, patients who have heart failure with slightly     less inefficient hearts will be observed to see if the electrical pacing treatment is better     than not getting the treatment. This study is being conducted to support FDA approval of this     type of pacemaker for people whose heart failure is less inefficient.   "
118423|NCT01735903|"     The purpose of this study is to measure the effect of nerve decompression on the recovery of     the treated nerves. To obtain objective data during surgery of the treated nerves' via     electrical signals and muscle power when stimulated. Also, to monitor muscle strength,     balance/gait and blood flow in the lower extremity before and after surgery.   "
118424|NCT01735890|"     The objectives of this study are:        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge          10/160mg after a single oral administration in healthy male volunteers        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis          Exforge 10/160mg after a single oral administration in healthy male volunteers   "
118425|NCT01735877|"     Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the     environment contra lateral to a cerebral lesion, can be a major source of functional handicap     after stroke. The currently available treatments for unilateral neglect are scanning     training, visual cuing approaches, limb activation strategies, visual imagery, tactile     stimulation, prisms and sustained attention training.Mirror therapy improves the hand     function in sub-acute stroke.      Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke     patients with unilateral neglect.   "
118426|NCT01735864|"     The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat     psoriasis has been proven effective in our previous study. This study aims to evaluate the     efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO     ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of indirubin)     in treatment of various local skin signs and thickness of psoriasis plaque.   "
118427|NCT01735851|"     Pain following abdominal surgery is managed with the use of thoracic epidural analgesia (TEA)     where the epidural is inserted in the spine at the level of scapula The risks due to TEA     include difficulty with insertion, failure in up to 40% of patient in the perioperative     period, fall in blood pressure and a rare devastating complication of paralysis either due to     bleeding or infection. Injury to spinal cord is also a feared complication. Therefore     alternative techniques need to be evaluated. Paravertebral block (PVB) has been documented to     provide pain relief following abdominal surgery using an earlier technique which posed the     risk of puncture of the covering to the lung (pleura) resulting in pneumothorax. The current     technique involves the use of curled catheters inserted using ultrasonography to lie outside     the pleura where the nerves travel thus reducing the chances of pneumothorax and catheter     migration. Objective of the current study is to compare the efficacy and safety of bilateral     PVB with TEA. Patients undergoing bowel surgery will be randomized to receive thoracic     epidural analgesia or bilateral thoracic paravertebral blocks. Pain scores during rest and     coughing, failure and complication rates will be compared between the two groups.      Objective:      The objective of the investigators is to determine whether ultrasound (US)-guided bilateral     thoracic paravertebral blocks (PVB) using curled catheter provides effective post-operative     analgesia as compared to thoracic epidural analgesia in patients undergoing open abdominal     bowel surgeries.      The primary outcome of this study will be the pain scores over the first 24 hours following     open bowel surgeries.      Secondary outcomes include        1. Analgesic consumption in the perioperative period,        2. Block related data (block performance time, success rate, extent of sensory block,          complications)        3. Hemodynamic parameter every 6 hourly        4. Incidence of side effects like nausea and pruritus scores, time to return of bowel          activity      Hypothesis      Null Hypothesis: Primary.      Paravertebral blocks provide equal analgesia in the early postoperative period (first 24     hours of surgery) as compared to thoracic epidural analgesia in patients undergoing bowel     surgeries by laparotomy.      Secondary        1. The analgesic consumption between PVB and TEA is not different during the first 24 hours          following surgery        2. The block performance time, success rate and extent of sensory block with PVB are not          different from that of TEA.        3. Side effects and complications following bilateral PVB are not different from those          occurring after TEA   "
118442|NCT01735656|"     Percutaneous coronary intervention (PCI) for the treatment of coronary bifurcation lesion     (BL) remains a challenging task. The DK-crush have been established as a safe and efficacious     dual-stenting technique, which can effectively improve the success rate of final kissing     balloon inflation (FKBI) and reduce long-term major adverse cardiac events (MACE). However,     in the clinical real world, especially when the bifurcation angle was relatively small, the     DK-crush still has several limitations, such as kissing unsatisfied (KUS), relatively complex     wiring or rewiring technique, incomplete stent coverage in the distal side of the side-branch     ostium and near the carina, severe stent deformation or evenly acute stent destruction. Our     observational study showed that the DK-culotte was also a safe and feasible dual-stenting     technique and was equal to DK-crush in terms of improving FKBI and MACE. Nonetheless, there     remain no studies for head-to-head comparison of clinical outcomes between the two     approaches. We, thereby, carry out a multicentre, non-inferior, randomized and controlled     trial to compare DK-culotte stenting versus DK-crush stenting in the treatment of true BL.   "
118443|NCT01735643|"     Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes     mellitus is increasing. Although in early phases the disease might be successfully treated by     lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication     a highly motivational system with low inhibition threshold is needed. Therefore, the     investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks     is able to improve HbA1c and weight in patients with type 2 diabetes.   "
118444|NCT01735630|"     The primary purpose of this study is to determine whether ELND005 is effective in treating     symptoms of agitation and aggression in patients with Alzheimer's disease   "
118999|NCT01728324|"     The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI     207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically     infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.   "
118428|NCT01735838|"     Summary Rationale: Cardiac resynchronisation therapy (CRT) with biventricular pacemakers and     implantable cardiac defibrillators (ICD) has proven to be a valuable therapy in selected     patients with systolic heart failure, ameliorating both morbidity and mortality. However,     with current selection criteria and implant technique, about 20 to 30 % of patients remain     non-responders. Non-responders might be due to failing selection criteria or methodology in     casu echocardiography. Moreover, the definition of response to CRT is unequivocal and there     is a need for a simple and reproducible measure of response with low inter- and     intra-observer variability.      Primary objectives: This study evaluates the correlation between intrathoracic blood volume     (ITBV) measured by contrast enhanced ultrasound (CEUS) and magnetic resonance imaging (MRI),     as well as the feasibility to use intrathoracic blood volume as a predictor for response to     CRT.      Study design: a prospective nonrandomized pilot study Study population: patients with heart     failure New York Heart Association (NYHA) class III or IV, a left ventricular ejection     fraction equal to or less than 35% and a QRS-duration equal to or more than 0.12 seconds who     are referred to our centre for implantation of a CRT-P or CRT-D device.      Intervention: No specific intervention will be performed. Main study parameters: correlation     between intrathoracic bloodvolume measured by CEUS and MRI, correlation between LVEF measured     by CEUS and by standard 2D ultrasound (biplane methods of discs), change in intrathoracic     blood volume as a response to CRT.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: at baseline a clinical examination, laboratory analysis, cardiopulmonary     exercise testing, echocardiography and cardiac magnetic resonance imaging will be performed.     All of these examinations will be repeated at 3-months follow-up except for the cardiac     magnetic resonance imaging. All examinations, except for the MRI, are part of the standard     workup in our hospital for patients undergoing implantation of a CRT device. Data needed for     the purpose of this study, will be acquired by offline image analysis with dedicated     software.   "
118429|NCT01735825|"     The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy     using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug     eluting stents releasing everolimus.   "
118430|NCT01735812|"     The goal of this study is to evaluate the safety & efficacy of cryoablation using IceCure     medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a     percutaneous lap-assisted approach.   "
118431|NCT01735799|"     Since both pathologies (PCOS and NAFLD) involve disturbed carbohydrate economy, which revolve     around insulin resistance, it is tempting to examine the specific liver profile of women     with PCOD. Furthermore, it would be of great importance if lean women who suffer from PCOD     would be revealed to shere cardiovascular risks with their more overweight peers.      Patients - women who will be diagnosed with PCOD following their initial referal to our     fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due     to either unexplained or male factor infertility.      Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism;     ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for     validation of the diagnosis and for ruling out other pathologies which may cause anovulation.      Liver profiling - The following blood tests will be used for the biochemical profiling:     fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH,     alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin     ratio.      FibroScan® will be used to measure liver stiffness.   "
118432|NCT01735786|"     Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment     techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common     complication following EMR. Several endoscopic hemostasis methods are currently in use.     EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was     previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic     application remains unknown. This study has been designed to observe the effect of rebleeding     prevention after EMR.   "
118433|NCT01735773|"     The investigators aimed to study the effect of prohepcidin levels on hematologic parameters     and inflammatory markers in non-diabetic uremic patients. The investigators selected three     groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4     chronic kidney disease. A control group was formed from healthy volunteers also. Each group     has been planned to be formed of about 25 patients. Diabetic patients were excluded.     Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine     biochemical analysis including hematological ones.   "
118434|NCT01735760|"     Anesthesiologists get a course on localizing the cricothyroid membrane on a human using     ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either     palpation or ultrasonography, in a randomised fashion, is tested.   "
118435|NCT01735747|"     In this trial, we will treat newly diagnosed PCNSL with temozolomide, nedaplatin, vincristine     (TNV) as the replacement of high-dose methotrexate to combine with concurrent     chemoradiotherapy. Our objective was to assess our treatment strategies' availability based     on response rates, progression-free survival (PFS), median PFS, and toxicity.   "
118436|NCT01735734|"     The purpose of this observational study is to ascertain the effects of cutaneous air cooling     on vessel diameter within Capillary Malformations (CM).   "
118437|NCT01735721|"     The aim of this study was the radiographic and clinical comparison of Algipore with     decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique     using piezoelectric instruments.   "
118438|NCT01735708|"     The purpose of this study is to determine whether participation in the study intervention,     which involves collaboration between the study interventionist and the participant's primary     care physician, will reduce symptoms of pain and depression in HIV+ patients.   "
118439|NCT01735695|"     The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic     fluid samples will be tested for meconium with a new assay. The results will be correlated     with other laboratory tests.   "
118440|NCT01735682|"     It is hypothesized that whole body vibration exercise group will have significantly more     improvement in physical functioning and reduction in fall incidence among institutionalized     elderly, compared with conventional exercise group and control group.   "
118441|NCT01735669|"     Objectives: The objective is to demonstrate the superiority of remifentanil versus nitrous     oxide as adjuvant analgesic treatment to increase the chances of success of external cephalic     version in the management of non-cephalic presentation in women with singleton pregnancy at     term. Another objective is to compare their safety, tolerability and acceptability.      Methodology: single-center clinical trial, randomized, open, parallel-group and sequential     design, with active comparator. Pragmatic approach. Sequential design of O'Brien-Fleming with     two interim analysis. Analysis by intention to treat. Comparison of the rate of successful     version, referred to analgesic effect, safety, caesarean rates and acceptability rate of the     procedure for pregnant women.   "
119000|NCT01728311|"     The purpose of this study is to determine the safety, tolerability and the pharmacokinetics     of BAY1082439   "
118445|NCT01735617|"     The purpose of this study is to gather safety and effectiveness information about a new     formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called     congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone     cortisol, which is released in the body following a regular daily pattern. The objective of     the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream     once Chronocort® is taken and what affects it has on other hormones in the body. Since     Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is     hoped that patients with CAH will be treated more effectively to manage their disease.   "
118446|NCT01735604|"     RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may     make the body build an immune response to kill cancer cells.      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in     treating patients with B-cell leukemia or lymphoma that is resistant or refractory to     chemotherapy.   "
118447|NCT01735591|"     The aim of this study was to evaluate the impact of the administration of probiotics on     outcomes of patients qualified for liver transplantation, both in the pre-transplant period     and in the early postoperative period.   "
118448|NCT01735578|"     Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in     the newborn intensive care unit and represents a significant cause of morbidity and mortality     in infants born prematurely. Among possible risk factors, a strong association between     elective RBC transfusions in premature infants with anemia and the subsequent development of     NEC has been consistently observed (6-11). However, a significant (and increasing) number of     VLBW infants with anemia are managed with erythropoiesis stimulating agents (such as Epo) and     iron and do not receive RBC transfusions during their hospital stay. The present study     proposes to study this particular group of VLBW infants that remain with low (<28 %)     hematocrit while receiving full enteral feedings.      The investigators hypothesize that significant anemia in VLBW infants will be associated with     a baseline low cerebro-splanchnic oxygenation ratio (CSOR) (<0.75) as measured by NIRS, and     that nasogastric feedings (NGF) in those particular patients will lead to further decreased     splanchnic oxygenation. The investigators further postulate that CSOR values will be     significantly lower among VLBW that develop NEC as compared to infants that do not.   "
118449|NCT01735565|"     This is a prospective observational study to determine the point after bone marrow transplant     in adults and children at which the neutrophils derived from the transplanted stem cells are     competent to form functional neutrophil extracellular traps (NETs). Furthermore, given the     importance of platelet function for NET formation, we also plan to examine platelet     activation and function as well as the platelet transcriptome using the same clinical     samples.   "
118450|NCT01735552|"     Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading     cause of morbidity and mortality among premature infants. NEC is the most common     life-threatening gastrointestinal emergency encountered in the neonatal intensive care unit,     affecting between 3.8% and 13% of very low birthweight (VLBW) infants (1-3). More recently     interest has intensified regarding the possible association between elective red blood cell     (RBC) transfusions in premature infants and the subsequent development of NEC (4-9). On a     physiological basis, a few explanations for transfusion-associated NEC have been proposed: 1)     the physiological impact of anemia that can initiate a cascade of events leading to     ischemic-hypoxemic mucosal gut injury predisposing to NEC [10]; and 2) increased splanchnic     blood flow following RBC transfusion leading to reperfusion injury of gut mucosa.      Aim 1. This study will quantify inflammatory cytokine profiles in anemic infants cared for in     the NICU prior to and after transfusion with packed red blood cells (PRBC), as dictated by     current clinical guidelines for treatment of anemia, and prospectively assess for clinical     signs and symptoms of NEC following each transfusion event.      Aim 2. Polymorphonuclear leukocytes (PMNs) isolated from the pre- and post-transfusion blood     samples will be assessed in vitro for neutrophil extracellular traps (NET) formation.      Aim 3. A) To determine whether significant anemia preceding a RBC transfusion is associated     with impaired intestinal oxygenation, and whether a RBC transfusion temporarily increases     splanchnic oxygenation. We postulate that the CSOR will be low (<0.75) at baseline     measurement in infants with hemodynamically significant anemia, and that RBC transfusion will     temporarily increase intestinal perfusion in that particular group of babies.      B) To determine whether alterations in mesenteric regional oxygenation saturation(rSO2) can     predict the development of NEC in VLBW infants. We hypothesize that overall     cerebro-splanchnic oxygenation ratio (CSOR) values will be significantly lower among very low     birth weight (VLBW) infants that develop NEC, when compared to CSOR values obtained in     infants that do not develop NEC following RBC transfusion.   "
118451|NCT01735539|"     The investigators plan to measure changes in muscle protein metabolism in response to     feeding, comparing between a single large essential amino acid (EAA) feed (the normal     building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min     intervals. The investigators will perform this study in healthy older (65-75y) and younger     (18-28) men. The investigators will also explore how feeding affects muscle blood flow as     this is important in the delivery of the nutrients we eat to the muscle where they are used.      The investigators plan to supplement the feed with arginine, a safe and widely found     non-essential amino acid, to explore if this can improve muscle blood flow.   "
118452|NCT01735526|"     Early after allogeneic hematopoietic stem-cell transplantation (allo-HSCT), reductions of     absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently     detected even in the absence of overt idiopathic pneumonia syndrome (IPS). It can be     hypothesized that these changes might be due to an occult intersitial lung disease associated     with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens     or any combination of these. To test this hypothesis, we will simultaneously measure the lung     diffusing capacity for nitric oxide (DLNO) and DLCO and estimate the changes of membrane     diffusing capacity (DM) and pulmonary capillary volume (Vc) by the DLNO/DLCO ratio. As we     hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT)     recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with     those of subjects undergoing allo-HSCT.   "
118453|NCT01735513|"     Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve     implantation by the use of an embolic protection device.   "
118454|NCT01735500|"     A prospective Study, aiming to understand and analyse the key role of the novel High     Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated     coronary angiography without receiving any additional intervention. The peri-procedural     elevation of the hsTnT indicates some other factors being responsible for the elevation of     the hsTnT in absence of an acute coronary syndrome, such as physiological components or     micro-injuries. A one year follow-up has been collected.   "
118455|NCT01735487|"     The aim of the present study is to compare cognitive scores (attention, executive function     and working memory) of different e-Cigarette strength with usual cigarettes.   "
118457|NCT01735461|"     Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is     common, particularly among Crohn's patients who had a small bowel resection. This patient     population experiences a lifetime occurrence of kidney stone formation as high as 25%     accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in     the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an     attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary     oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium.     This study's primary objective is to scientifically define an appropriate range of calcium     supplementation that reduce the level of oxalate found in the urine of patients living with     inflammatory bowel disease.   "
118458|NCT01735448|"     Aim: To identify barriers and facilitators in the uptake of smoking cessation     pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held     health priorities and barriers to research in Aboriginal Australians from the perspectives     of:        -  Aboriginal smokers and ex/non-smokers        -  Aboriginal Healthcare workers        -  Consultants/general practitioners, and        -  Key stakeholders in Aboriginal health      Focus groups, one-on-one interviews and surveys will be conducted to provide information at     the 'grass-roots' level including examinations into perceived differences in locally held     beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs,     to assist implementation of future tobacco cessation/prevention interventions and treatment     of smoking related illnesses. This information can be used to improve the health of     Aboriginal people by identifying inadequacies in current practices and highlighting what     these are through the eyes of community members, healthcare workers, consultants/general     practitioners and key stakeholders. We also intend on examining any facilitators that are     identified as positive and working aspects of current initiatives e.g. community     infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.   "
118459|NCT01735435|"     The aim of this study to assess the impact of nutritional support guided by repeated     measurements of REE in geriatric patients following surgery for hip fractures.      Our hypothesis is that tight caloric control will reduce the risk of significant     postoperative complications in geriatric patients following surgery for hip fractures.      Study Design :Prospective, Single center, Randomized, Unblinded study. Study     Population:geriatric patients following surgery for hip fractures.   "
118460|NCT01735422|"     This is a single center, open-label, randomized, parallel group, dose finding study to     evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®),     compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given     subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular     growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).   "
118461|NCT01735409|"     This is a single center, non-randomized phase IIa study to determine the tolerance and safety     of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced     nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been     infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE     V4.0 and RECIST 1.1 respectively.   "
118462|NCT01735396|"     This is a pilot study of abiraterone acetate in African American/Black patients with     castration-resistant prostate cancer. The primary objective is to determine the correlation     between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥     30%) in African American patients with castration-resistant prostate cancer treated with     abiraterone acetate. Patients will receive abiraterone acetate until the time of disease     progression, in the absence of prohibitive toxicities. Patients will be followed for disease     progression and survival.   "
118463|NCT01735383|"     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,     two-period, crossover pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fed     condition in healthy, adult human subjects.   "
118464|NCT01735370|"     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,     two-period, crossover pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fasting     condition in healthy, adult human subjects.   "
118465|NCT01735357|"     The purpose of this study was to determine whether supplementation with oils enriched with     long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial     and vascular function.   "
118466|NCT01735344|"     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fed condition in normal,     healthy, adult, male and female human subjects.   "
118467|NCT01735331|"     The aim of this study is determine vascular endothelial growth factor levels and     angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients     who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels     will be measured by immunohistochemical staining methods due to office hysteroscopic     endometrial biopsy after the menstruation at follicular phase of menstrual cycle.   "
118468|NCT01735318|"     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fasting condition in     normal, healthy, adult, male and female human subjects.   "
118469|NCT01735305|"     Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients     with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy     are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to     demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients,     and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18     years old who were diagnosed as CAD and received antiplatelet therapy were prospectively     enrolled in this national wide, non-intervention registry. All medications and laboratory     tests were physician discretion.   "
119001|NCT01728298|"     The primary objective of the trial is to evaluate the dose-response relationship with regards     to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in     adult subjects with moderate to severe HDM allergic rhinitis.   "
118470|NCT01735292|"     The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to     have their ventilator placed on a timer which at a specific time in the future stops the     ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to     be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration     Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes     during the use of the timer with the regular ventilator. In addition, we will evaluate     whether the timer stops the ventilator and switches to CPAP at the designated time.   "
118471|NCT01735279|"     Nicotine dependence may prolong the exposure to toxic substances that cause various diseases.     The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty     Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the     modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning     of the mesolimbic and mesocortical pathway, related to the reward system, involved on the     context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows     improvements in several diseases, including mood disorders such as anxiety and depression.     The investigators hypothesis is that supplementation with these fatty acids can restore the     levels of omega-3 and could decrease nicotine dependence. The investigators objective is to     investigate a possible association between increased serum levels of omega-3 and the     reduction in nicotine dependence.   "
118472|NCT01735266|"     In most of situation, left colon (especially SD junction) is considered the most difficult     part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and     patients may feel pain or uncomfortable. It is suggested more than half of the whole time for     scope insertion should be used in left colon. Many methods, such as water immersion,     abdominal palpation, have been used to facilitate insertion in left colon.      Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing     medication used, pain experienced during colonoscopy, increasing the success rate of cecum     intubation and adenoma detection rate in sedated and unsedated patients undergoing screening     colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents     lengthening and distension of the colon during colonoscopy. This will facilitate the     colonoscopy in average or difficult colonoscopy. However, it is not known whether the     benefits of water exchange method of colonoscopy was mainly due to its effect on the left     colon.      We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect     regarding the maximal pain score and mean pain score in unsedated patients compared with     whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion     time compared with WWE. Here we performed a prospective, randomized controlled study to     investigate the efficacies of whole-colon water exchange, left-colon water exchange and air     methods of colonoscopy on pain score and insertion time in unsedated outpatients.   "
118473|NCT01735253|"     Surgical treatment for type 2 diabetes has been taken note especially in less obese or non     obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater     than that of the obese.      We are trying to do a prospective observational study for the evaluation of the effect of     duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.      The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral     obesity, insulin use less than 10 years and the patients understanding the hypothesis of this     study, risks, expecting effects and agreeing this study.      We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some     anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.      We will compare the clinical factors at each time.   "
118474|NCT01735240|"     The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile     when administered with ketoconazole. Subjects will be treated first with AZD5069 only     followed by a washout period before starting with the combined treatment (both ketoconazole     and AZD5069).   "
118475|NCT01735227|"     In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect ,     the investigators designed a clinical randomized controlled trials of omeprazole and     pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigators have     taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly     divided into omeprazole and pantoprazole groups . On the day of admission , all patients     taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of     clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,     pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (     before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each     taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet     aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical     adverse events ( including death , myocardial infarction , and any revascularization , stent     thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding     events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year     follow-up results , and further explore the optimal combination of dual anti-platelet and     joint PPIs course of treatment , appropriate dosage and the best time to provide reasonable     for clinical programs to create a personalized treatment system , improve the patient's     quality of life .   "
118476|NCT01735214|"     This study is a prospective, observational study of changing from any IOP-lowering treatment     to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open     Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies     with the physician according to their standard practice.   "
118477|NCT01735201|"     This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice     daily compared to vehicle for the treatment of moderate to severe facial erythema associated     with rosacea.   "
118478|NCT01735188|"     Primary objective:      Characterize the natural history of MoCD type A in terms of survival      Secondary objectives:        1. Evaluate blood and urine for biochemical markers        2. Evaluate head circumference, seizure activity and neurologic outcomes        3. To evaluate brain MRI        4. Compare blood and urine analysis, head circumference, seizure activity and neurologic          outcomes to MRI findings   "
118479|NCT01735175|"     The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the     mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in     breast cancer patients.   "
118480|NCT01735162|"     Acute kidney injury (AKI) is a common clinical event with severe consequences. In the     pediatric intensive care unit (PICU), AKI occurs in almost 10% of all patients and evidence     suggests that children are dying not just with AKI, but from AKI. Unfortunately, the     treatment for AKI is limited to a great extent by delayed diagnosis. Reliance on markers of     kidney injury that change only when significant damage has already occurred has rendered     potential therapies ineffective. For this reason, identification of new markers of AKI that     change early in the course of injury is paramount. While new AKI biomarkers have been     identified, their performance in the general PICU population is variable. The investigators     recently proposed the concept of 'renal angina' as a way to risk stratify patients in the ICU     for AKI risk. In the AKI-CHERUB study, the investigators propose to study renal angina in     PICU patients alone and in combination with urinary biomarkers for AKI prediction. The     investigators hypothesize that renal angina will increase the predictive precision of urinary     biomarkers for AKI.   "
118481|NCT01735149|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids.     The investigators measured improvement of blood lipids parameters , including Total     Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.   "
118482|NCT01735136|"     The investigators performed a 4-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of Helicobacter     pylori infection. The investigators measured improvement of Helicobacter pylori infection     parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and monitored their     blood pressure.   "
118483|NCT01735123|"     The proposed mechanistic formula feeding study sets out to identify the mechanism(s) by which     an extensively hydrolyzed casein formula is able to protect children at risk for type 1     diabetes (T1D) from beta-cell autoimmunity.   "
118484|NCT01735110|"     The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus     TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.   "
118485|NCT01735097|"     Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical     keratosis   "
118486|NCT01735084|"     HYPOTHESES:        1. That infants receiving PHiD-CV10 as a booster at 13 months of age, compared to controls          having no PHiD-CV10 booster (i.e. standard PCV13), will have higher HiD antibody levels,          lower carriage of NTHi, and less tympanic membrane perforation at 18 and 36 months of          age.        2. That infants receiving PCV13 as a booster at 13 months of age, compared to controls          having no PCV13 (i.e. PHiD-CV10 booster) will have higher antibody levels to serotypes          3, 6A and 19A, less carriage of these serotypes, and less tympanic membrane perforation          at 18 and 36 months of age.   "
118487|NCT01735071|"     This study is aimed at assessing the efficacy and the safety of the combination of     bevacizumab and trabectedin with or without carboplatin in adult women with epithelial     ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or     second) platinum-containing regimen. According to the Bryant and Day design the primary     endpoints will be the proportion of progression-free patients at 6 months for the efficacy,     and the proportion of patients with severe toxicity for the safety at the same time-point.   "
118488|NCT01735058|"     This study will be performed to examine the effect of ultrasound-guided subacromial sodium     hyaluronate injection in patients with impingement syndrome without rotator cuff complete     tear.   "
118489|NCT01735045|"     This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft     contact lenses when used as a daily wear contact lens for the correction of myopia.   "
118490|NCT01735032|"     Epilepsy is the most common chronic neurological disorder in the world, affecting more than     50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to     all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal.     Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily     due to seizure-related fatalities, in comparison with the general population. The only     therapeutic option for this form of epilepsy is the surgical removal of the region of the     brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise     localization of the EZ based on a comprehensive pre-surgical evaluation of patients.      Today the gold standard for localizing the EZ and validating a non-invasive technique for     localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or     SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral     depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic     Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose)     and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the     pre-surgical localization of the EZ has already been shown, no wide-scale study has examined     the cumulative contribution of these three techniques.   "
118491|NCT01735019|"     In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough     during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage.     Previous reports demonstrated that administration of remifentanil during anesthetic emergence     could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the     objective of this study is to determine EC95 of remifentanil for preventing cough during     anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.   "
118562|NCT01734096|"     The purpose of this study is to determine whether in pre-hypertensive and hypertensive states     such as white coat hypertension, obesity related hypertension or resistant hypertension,     renal function is more sensitive to orthostatic stress.   "
118492|NCT01735006|"     This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine     manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to     demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18     years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity     and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference     of safety and immunogenicity among different lots. Approximately 6000 study subjects will be     enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV)     vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a     0-1-6 month schedule.   "
118493|NCT01734993|"     This multicenter, open-label, single arm, interventional, long-term extension (LTE) study     will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French     participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE     study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed     the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having     improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2     points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of     subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever     occurs first.   "
118494|NCT01734980|"     Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial     ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples     when no suction is applied.   "
118495|NCT01734967|"     Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of     patients being alive at five years. EUS (endoscopic ultra sound) is an established, sensitive     diagnostic tool in pancreatic cancer and for staging purposes. Additionally, EUS enables     guided fine needle aspiration (FNA), which is currently recommended as the first-line     procedure whenever a pathological diagnosis is required. However, EUS-FNA as a sampling     method has its drawbacks, due to a relatively low negative predictive value. Confocal laser     endomicroscopy has emerged in recent years as a novel method that enables in vivo microscopic     analysis during ongoing endoscopy. Recently, confocal laser endomicroscopy has gone beyond     the superficial luminal indications with the development of a new microprobe, i.e. a flexible     laser probe (nCLE) that can pass through a 19-gauge needle. Combined with EUS, descriptive     criteria for the diagnosis of pancreatic cystic neoplasm has been developed in a multicentre     trial. However, only a limited number of cases of solid pancreatic masses have been described     with nCLE.      Aim and Method: To describe confocal imaging criteria for pancreatic masses, lymph nodes or     liver metastases identified during EUS procedures performed for pancreatic cancer staging     (EUS-nCLE), while evaluating also the feasibility and safety of nCLE examination. The     hypothesis is that EUS-nCLE could allow targeted tissue sampling of pancreatic lesions     resulting in more accurate diagnosis. XX patients were included all presenting with a     clinical suspicion of pancreatic cancer or imaging studies showing a pancreatic mass. During     the procedure an nCLE preloaded 19G FNA needle was advanced into the lesion under EUS     guidance. A contrast agent was administered intravenously (2.5 ml fluorescein 10%). The data     was stored digitally for post procedural analysis. Afterwards EUS-FNA was performed for     cytology smears to enable a final pathological diagnosis. Correlations between the nCLE     images and the conventional pathology were identified.   "
118496|NCT01734954|"     The purpose of this study is to evaluate the latency period (timing between the injection of     the local anesthetic and the onset of complete sensory nerve block) of two approaches for     ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of     the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is     injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned     nerve. Our main hypothesis is that the first approach will decrease the latency period, and     probably, will increase the success rate of the nerve block as well as patient satisfaction.   "
118497|NCT01734941|"     The primary objective of this study is to evaluate and compare the safety and efficacy of     Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism.      Evaluation of the safety and tolerability of treatment with TSO in the target population     across the dose range being tested is considered a primary objective, while the primary     efficacy objective will be assessed via the change from baseline in the Aberrant Behavior     Checklist (ABC) subscale scores.      Dose response will be considered a primary objective as well.      Secondary assessments of efficacy will be assessed via:      • The change from baseline in the Clinical Global Impression scale (CGI-I)   "
118499|NCT01734915|"     The purpose of this research study is to determine if the EGFR mutation can be detected in     CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the     bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of     patients with cancer. This is an experimental device. Using this device, the investigators     will test participants' blood to try and find CTCs with the EGFR mutation and compare them     with the results from the biopsy your doctor has recommended. The long-term goal of this     research is to develop a way to test for the EGFR mutation that is less invasive than a tumor     biopsy.   "
118500|NCT01734902|"     The objective of the current trial is to establish the bioequivalence of 2 hyoscine     butylbromide dose forms following oral administration.   "
118501|NCT01734889|"     The purpose of this study is to verify that pediatric patients, especially those who are not     old enough to swallow capsules, accept the taste and palatability of a new suspension.   "
118502|NCT01734876|"     The Parkitouch study compared the effects on pain, sleep quality and HealthRelated Quality of     Life (HRQoL) among 44 participants with Parkinson´s Disease for at least two years and     chronic pain.The two groups were randomized to either Tactile Touch and Rest to Music or only     Rest to Music alone. It was prospective and had a duration of 34 weeks. The first 10 weeks     was the intervention period , followed by a follow-up period. Outcome measures were salivary     cortisol concentration measured at seven occasions of which two were immediately before,     after and 30 minutes after intervention. Diurnal salivary cortisol was calculated based on     four timepoints of sampling per 24 hour period.   "
118563|NCT01734083|"     The whole body vibration exercise group will have significantly more improvement in mobility,     muscle strength, balance, balance confidence, and cognitive function with a lower fall rate     than the control group.   "
121687|NCT01693133|"     The objective of this study is to evaluate the percentage of patients with complete diabetic     foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human     amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.   "
118503|NCT01734863|"     Local recurrence after surgical resection is a complex phenomenon. An important predictive     factor is the response to chemotherapy. Central site of disease may be a second independent     predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at     surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free     Survival [EFS] of 47% after 10 years. Patients with good histological response (< 10% viable     tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.      However, further studies are necessary to determine the merit of adjuvant radiation for     high-risk patients (poor responders). Taking into consideration that the toxicity and     morbidity of combined surgery and radiation is greater than either alone and must be closely     monitored.   "
119015|NCT01728116|"     To determine if the EndoBarrier safely and effectively improves glycemic control in obese     subjects with type 2 diabetes   "
118504|NCT01734850|"     This is an early phase research study looking at whether an experimental gene transfer,     LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the     effects of HIV without the use of antiretroviral drugs.      Cal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2     active parts:        1. Removing a protein named CCR5 from bone marrow and white blood cells        2. Producing a protein named C46 on bone marrow and white blood cells   "
118505|NCT01734837|"     Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute     appendicitis. Although the surgical technique of laparoscopic appendectomy has been well     established, some controversy exists regarding the closure of the appendiceal stump. The     available methods for stump closure are currently: pre-knotted loops (Roeder Loops or     Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation     Clip. The design of the DS-Clip is characterized by two parallel shanks.      The aim of this study is to collect data of a large number of patients treated with the     product in real-life clinical routine.   "
118506|NCT01734824|"     The etiology of bone marrow edema (BME) is still uncertain. Several studies report     therapeutic success with antiresorptive drugs.      This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME   "
118507|NCT01734811|"     The purpose of the study is to evaluate the efficacy of a biological vaccine to prevent     episodes of bronchospasm, induced by recurrent respiratory tract infections, in children,     compared with a placebo group.   "
118508|NCT01734798|"     Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local     recurrence is still the major cause of failure together with distant metastasis.     postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the     overall survival. Adjuvant chemotherapy has also improved the survival in different studies.     This study is performed to test the efficacy and toxicity of adding the two modalities     together compared to each modality alone.   "
118509|NCT01734785|"     This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM     patients on 16 wks linagliptin treatment and metformin background therapy.   "
118510|NCT01734772|"     To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and     ticagrelor under steady state conditions; to investigate the effect of staggered     administration of ticagrelor loading dose on dabigatran exposure (in Part II)   "
118511|NCT01734759|"     The purpose of this study is to see if a medication taste test influences the prescribing     habits of pediatric prescribers at Mayo Clinic.   "
118512|NCT01734746|"     As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel     lymph node surgery is to see whether the cancer has spread to the very first lymph node or     sentinel node. If the sentinel node does not contain cancer, there is a high likelihood that     the cancer has not spread to other lymph nodes. This means that, at least theoretically, a     radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel node     technique has been proven to be effective in different cancers such as breast cancer and     malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar     cancer. Currently sentinel node studies are done for cervix and uterine cancer.      The present study determines whether or not a sentinel node procedure in patients with     ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.   "
118513|NCT01734733|"     To assess the safety of xenotransplantation of NTCELL [immunoprotected     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed     over the duration of the study, by monitoring the occurrence of adverse events and serious     adverse events, including clinical and laboratory evidence of xenogeneic infection in     transplant recipients and their partners/close contacts. Subsequent safety follow-up will     include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.      To assess the clinical effects of NTCELL [immunoprotected (alginate-encapsulated) choroid     plexus cells] in patients with Parkinson's disease. This will be quantified by testing the     secondary endpoints of the trial as described below (see Endpoints/Outcome Measures).   "
118514|NCT01734720|"     The aims of this study were to        1. investigate what measures were taken when common bile duct stones (CBDS) were found          intraoperatively in Sweden during the period May 2005 to December 2009 by using data          from this population-based nationwide registry, and        2. analyze the outcome in terms of complications and success rates of bile duct clearance          in relation to various stone sizes and interventions used. In order to further          characterize the natural course of CBDS of various sizes, particular interest was          focused on patients with positive findings where no peroperative measures to clear the          bile ducts were taken or planned postoperatively.   "
118515|NCT01734707|"     This study was designed to estimate the effect of two-year treatment with time-released     garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded     placebo-controlled randomized clinical trial.   "
118516|NCT01734694|"     For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of     vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed     and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical     concern. This may be due to various reasons, including new dosing recommendations as well as     an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity.     This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin     use.   "
124075|NCT01661803|"     The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby     bringing about better quality and longer duration of analgesia, better sedation and better     postoperative outcomes with minimal side effects.   "
118571|NCT01733966|"     The primary outcome measure is to compare efficacy of an association of     Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid     during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among     Adults in clinical and biological cure.      The cure rate will be evaluated at the second visit (14 days after the inclusion visit)   "
118679|NCT01732731|"     The purpose of this project is to examine if early exposure to intensive, short-term     locomotor treadmill training (LT) in young children with neuromotor impairment will help     develop walking skills earlier, decrease the amount of outside assistance needed (such as a     walker or crutches) as compared to children with neuromotor impairment who receive     traditional physical therapy intervention.   "
118517|NCT01734681|"     Prostate cancer that has returned after local treatment usually responds to hormone blocking     treatment, but most patients eventually experience disease progression. Further chemotherapy     does not normally lead to a cure or dramatic improvement in the disease and there is a need     to identify new drugs that are beneficial for these patients without unacceptable side     effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is     administered to the patient and gets activated within the body at specific locations,     resulting in a higher concentration of the cytotoxic form at a tumour location whilst     avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have     many general side effects because it is converted to a cell toxin only at the tumour or other     specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen     (PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most solid     tumours, but not by normal cells or blood vessels in normal tissue. It is believed that     activation of the prodrug G-202 will allow the drug to kill cancer cells, particularly     prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with     castration-resistant prostate cancer (CRPC), which means the cancer has progressed after     hormone blocking treatment, but who have not yet received chemotherapy and who have no or     only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of     G-202 administered on three consecutive days of a 28-day cycle.   "
118518|NCT01734668|"     The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA     with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of     age.   "
118519|NCT01734655|"     The Specific Aim of this supplemental project is to evaluate the Mindful Eating Questionnaire     (MEQ) to determine if it is a valid instrument for pregnant women. During this project, the     MEQ will be qualitatively evaluated in a sample of pregnant women who are similar in age,     ethnicity, education, and marital status to the women targeted for recruitment in the parent     study. The qualitative evaluation will include a focus group with 10 participants followed by     30 individual cognitive interviews. Comments from the interviews will be summarized and     analyzed systematically for each of the 28 questions of the MEQ and the interviewer will use     findings from initial interviews to inform subsequent interviews. Content validity will be     evaluated based on responses from the focus group and cognitive interviews, and MEQ items     will be evaluated for comprehension, retrieval, judgment, and response. Strengths,     weaknesses, relevance, comprehensiveness, and interpretations will be reported for each of     the MEQ questions. We will also have some of the more traditional validation parameters (the     inclusion of other questionnaires) in the study to collect data on convergent and     discriminant validity. The resulting publication will provide readers with a thorough report     on the utility and appropriateness of using the MEQ to quantify mindful eating in pregnant     women.   "
118520|NCT01734642|"     A medication error is a failure in the treatment process that leads to, or has the potential     to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in     hospital. They can occur in different phases of the therapeutic process (prescribing,     distribution, administration and monitoring) and have significant impact on morbidity and     mortality. Prescribing faults and prescription errors are major problem among medication     errors .Prescription errors account for 70 % of medication errors that could potentially     result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 %     of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises     from a medication error it is potentially preventable. The medication errors project was     devised to analyze and limit through educational audit and other tools, as much as possible,     damages due to the therapeutic process. The project will include 5 phases. Preliminary phase:     organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health     professionals of involved units will review all patient charts and will register all adverse     drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health     professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a     panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II     :educational audits directed to health professionals will be organized. Tools to reduce the     medication errors will be proposed. Phase III: the same procedure of the first phase. Final     phase (IV): analysis of data with publication of a scientific article.   "
118521|NCT01734629|"     Several studies show an association between chronic obstructive pulmonary disease (COPD) and     coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with     physical inactivity, advanced age and systemic inflammation The use of coronary computed     tomography (CCT) with multiple detectors is a diagnostic method for coronary disease,     describing the anatomy and severity of arterial obstruction. One way of estimating the     cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and     CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.      The aim of this observational study is to establish the correlation between the CCS and lung     function. It will also correlate the presence of irreversible airway obstruction with     significant coronary lesions.      Patients over 40 years referred to CCT who agree to participate in the study will perform a     spirometry with bronchodilator and collect a blood sample to measure serum markers of     inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP),     tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the     general population and in subgroups: smokers, former smokers and nonsmokers.      One year after the CCT patients will be contacted by the investigators and accessed for     emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory     events.      The investigators hypothesis is that reduced lung function is independently associated with     elevated CCS and is, also a risk factor for increased hospital admission and coronary events.      The concomitant assessment of lung function and CCS can contribute knowledge about the     epidemiological association between pulmonary disease and CAD. This can also add to evidence     for the use of spirometry as a marker of cardiovascular risk.   "
118564|NCT01734070|"     The goal of this study is to examine if chronic cherry consumption will decrease lipid     peroxidation and serum concentration of inflammatory markers in human subjects with elevated     serum C reactive protein (CRP), and to examine the relationship between serum concentrations     of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce     serum concentration of inflammatory markers, including CRP, inflammatory cytokines and     adhesion molecules.   "
118565|NCT01734057|"     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known     hospitals in China. In order to report the efficacy and safety of Recombinant Human     thrombopoietin combining with Rituximab for the treatment of adults with primary immune     thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.   "
124076|NCT01661790|"     To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment     for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).   "
118522|NCT01734616|"     With age, muscles tend to waste at 0.5-1% per year, so that an 80 year old may have only 70%     of the muscle possessed at 50. Muscle loss makes it harder to carry out tasks that require     strength, keep the body balanced and continue activity for a prolonged period, which together     may contribute to a loss of independence and an increased risk of falls. The cause of some of     this muscle loss with ageing appears to be a reduction in muscle building in response to     food. The known decreased limb blood flow in ageing muscle may go some way to explain this as     there may be less nutrient delivery to the muscles. The investigators want to test if the     known decrease in limb blood flow with age is matched with a decrease in the proportion of     blood being delivered directly to the muscles, rather than fat and connective tissue. If so     the investigators expect to see an improvement in the ability of muscles to maintain     themselves via better capture of amino acids into protein. The investigators also want to     test if 20 weeks resistance exercise training or drinking a cocktail of mixture of high     flavanol cocoa (which can increase blood flow) and vitamin C can improve limb blood flow to     older muscles and help reduce muscle wasting.   "
118523|NCT01734603|"     Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with     claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to     patients with PAD have recently been proved effective and defined in many guidelines.     Supervised walking training on treadmill is recommended. Usually patients walk up to a mild     or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then     stop until pain completely subsides and walk again .      The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by     alternating short sequences of intensive training and active recovery (without rest).   "
118524|NCT01734590|"     Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.      The main objective is to identify one or two flour compositions in a carbohydrate-based food     that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative     absorption of exogenous glucose compared to the control.   "
118525|NCT01734577|"     Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of     musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine     for a neurophysiological effect.   "
118526|NCT01734564|"     In this phase II study, patients with solid tumors will receive treatment with hiltonol and     autologous dendritic cells.   "
118527|NCT01734551|"     The purpose of this study is to compare two different medicines to treat babies with opiate     withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a     non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine     is another drug, but is different from morphine. It is also used for babies, and even adults     for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if     one may be better than the other.   "
118528|NCT01734538|"     The biological membranes that surround a cell and its organelles are important to the overall     function of the cell. Fatty acids are the main structural components of a membrane, and the     presence of certain fatty acids can alter a membrane's characteristics, which subsequently     alters its function. Two fatty acids that are of particular interest to researchers are     eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These omega-3 fatty acids have     unique unsaturated structures, and their incorporation into biological membranes appears to     elicit potent physiological effects. The body is unable to intrinsically synthesize these     important fatty acids, so they must be obtained from the diet or through supplementation.      EPA and DHA supplementation has been reported to provide numerous positive health benefits,     including decreased blood pressure and an improved blood lipid profile. Recent research in     our laboratory has demonstrated in young men that resting metabolic rate was increased     following a 12 week period of omega fatty acid supplementation of 3 g/day. Fat utilization     was also increased and carbohydrate use was decreased both at rest and during a 1 hr moderate     exercise challenge. These findings have positive implications for people who are interested     in losing weight, but it not known whether these effects occur in older adults. With age,     body composition changes (increase in fat mass and decrease in lean mass) occur which may     negatively affect general health, particularly normal physical functioning and quality of     living of the older adult. The potential role of omega 3 fatty acids to increase fat     oxidation and increase resting metabolic rate may be a therapy for decreasing fat mass in the     older adult. Research has suggested that omega 3 fatty acids may elicit an additional     therapeutic role by reducing joint pain.      Another aspect of aging is a loss in lean body mass, which is associated with an attenuation     of skeletal muscle protein synthesis in response to nutritional stimuli (amino acids and     insulin). The weakened anabolic response is considered to be partly due to defects in the     anabolic signaling cascade in the muscle. Research in older adults has reported an increase     in muscle protein signaling with EPA and DHA supplementation in response to a nutritional     challenge. However it is unknown whether the increase in protein signaling results in an     eventual increase in lean body mass. The physical functioning of older adults is not only     influenced by body composition changes, but also age-related neuronal changes that affect the     velocity of axonal conduction and influence the ability of the muscle to generate torque and     the rate at which the torque is developed. Muscular strength and functional capacity     increases have been reported with chronic resistance exercise in a cohort of older women     supplemented with EPA and DHA. However, the effect of EPA and DHA intake on physical strength     in older adults with previously low EPA and DHA consumption, independent of exercise, is     currently unknown.      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega-3     supplementation at 3 g/day on metabolic and physical health parameters in community-dwelling     older adults. We hypothesize that EPA and DHA supplementation will result in 1) a decrease in     resting heart rate and blood pressure; 2) a more healthy blood profile; 3) an increase in     resting metabolic rate; 4) a greater reliance on fat oxidation for energy both at rest and     during exercise; and 5) a decrease in fat mass; and 6) an increase in lean mass, strength and     physical function.   "
118529|NCT01734525|"     This is a prospective study aimed at testing a strategy of early initiation of an antifungal     agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis.     Score system have been developed to identify groups at very high risk for the development of     candidemia/invasive candidiasis in the ICU. These scoring system have used clinical     information with or without data on Candida colonization, and have shown reasonable     correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of     1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The     incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at     higher risk for candidemia, and despite the fact that these tests may give false-positive     results, their negative predictive value could be of great help. Likewise, analyzing the     kinetics of these biomarkers in patients with candidemia/invasive candidiasis would help to     define their usefulness in monitoring treatment.      Therefore, the objectives of this study are:        1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop          invasive candidiasis/candidemia;        2. To evaluate the kinetics of positive biomarkers after initiation of antifungal therapy          in patients with candidemia;        3. To test the strategy of early discontinuation of antifungal therapy based on repeatedly          negative blood cultures and 1,3 beta-D-glucan in the serum.   "
118530|NCT01734512|"     This is an open label study of everolimus in children with recurrent or progressive low-grade     glioma.   "
118531|NCT01734499|"     This study is proposed to assess long-term Quality of Life issues in breast cancer survivors     by measuring the impact on the quality of life made by the structured Change Cycle Work     Shop coping class as compared to current local standard of care programs. It has been shown     that breast cancer treatment can have long-term bio-psychosocial consequences. Specific     evidence-based interventions are needed to address Quality of Life concerns in order to     improve the overall outcome of breast cancer and its treatment beyond the focus on mortality     rate.   "
118532|NCT01734486|"     This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two     somatropin dose regimens in girls with Turner Syndrome.   "
118533|NCT01734473|"     Weight loss commonly occurs in patients with COPD, negatively influencing their quality of     life, treatment response and survival. Loss of muscle protein is generally a central     component of this weight loss and independently increases mortality. This study will provide     relevant clinical information in regards to the anabolic properties of specific dietary     substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a     hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than     a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy     older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only     enhances the protein anabolic response in COPD patients and healthy older adults when     carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient     protein anabolic response to a hydrolyzed casein-based protein meal than healthy older     adults.      A fifth study day was added to measure protein requirements of included individuals to be     able to interpret their response to the other interventions on the other study days, and to     test the hypothesis that subjects with lower protein requirements respond less to     intervention with leucine and/or carbohydrates. For the 5th additional test day we will first     approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days     (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen     these subjects by phone for eligibility and check for changes in their recent medical history     (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still     met, these subjects will be asked to provide a written re-consent. If necessary, we will     recruit new subjects who will complete only one of the four test days (i.e. the test day on     which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the     additional 5th study day.   "
118566|NCT01734044|"     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known     hospitals in China. In order to report the efficacy and safety of Recombinant Human     thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune     thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.   "
118534|NCT01734460|"     Sleep disordered breathing (SDB) is a common condition affecting up to 9% of adults with     serious neurocognitive, metabolic and cardiovascular consequences that has a significant     impact on public health. Evidence indicates that the physiologic changes occurring during     pregnancy, particularly during the third trimester, increase the risk of those women to     develop SDB. As in the general population, SDB during pregnancy is more frequent among obese     women. In the light of the increasing prevalence of obesity among females of reproductive     age, SDB may thus have an increasingly significant impact on women's and children's health by     contributing to the adverse maternal and fetal outcomes associated with maternal obesity.      Only a limited amount of data is available on the consequences of maternal SDB during     pregnancy. Even less information is available on the effect of maternal SDB on fetal growth     and development. The current proposal is designed to specifically explore the effect of     maternal SDB on fetal growth.      It has been suggested that fetal growth as reflected in birth weight is a strong correlate     for conditions occurring in the intrauterine environment with potential long lasting     influence on a child's health.      Our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the     metabolic alterations associated with maternal SDB will affect fetal growth.      Using a variety of methods and a multidisciplinary approach, we will explore the following     objectives: 1) The effect of maternal SDB on fetal growth ; 2) To explore mechanisms that may     underlay the effect of maternal SDB on fetal growth 3) To explore the long term (first 3     years of life) effect of maternal SDB on a child's growth.      The results of this study will make an important contribution to the fields of women and     children's health. It will provide better insight into the mechanisms by which disrupted     maternal sleep affects fetal growth.      We expect that the findings from our study will enable the defining of a new treatable     clinical entity or syndrome: the infant of the gestational SDB mother, for which early     diagnosis and intervention might be of major importance to the newborn infant.   "
118535|NCT01734447|"     This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term     growth hormone treatment in growth-retarded children with intrauterine growth retardation     (IUGR) enrolled in trial GHRETARD/F/1/F.   "
118536|NCT01734434|"     This study will collect information regarding the factors that might influence access of     pregnant women to the local healthcare system. The main visits of the study will be screening     & enrollment, delivery and 90 day infant follow-up. Data will be collected mainly from     questionnaires administered to pregnant women at these visits. The questionnaires contain the     following standard questions which will be asked at each visit, in addition to some     visit-specific questions related to delivery and health status of infants up to 90 days of     age. The standard questions will be related to the following aspects:        -  Logistics of transportation to the study site (type, time it takes, cost incurred)        -  Accessibility to a telephone/cell phone        -  Provisions of alternative child care during site visits if there are other children          under the subject's care   "
118537|NCT01734421|"     AIM: To assess the efficacy of an intervention based on the specific design and     implementation of a mobile application (APP) in order to reduce the prevalence of smoking     consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical     trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat     analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18     to 30 years consulting for any reason to PHCC and who provided written informed consent to     participate in the trial.      INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline     smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME     MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of     less or iqual 10 parts per million in each control.      RESULTS: The application of a smoking cessation intervention with a mobile APPs application     will improve the smoking cessation success rate in smokers, besides of their intention or not     to give up smoking at baseline.   "
118538|NCT01734408|"     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused     by viruses that belong to the enterovirus genus of the picornavirus family. Although most     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71     (EV71) can present with a high rate of neurological complications, including     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic     potential of EV71 clearly requires the attention of world medical community.      The phase II study of inactivated vaccine (vero cell) against EV71 has completed last month     in Jiangsu Province in China. The data from the phase II study suggested that the inactivated     EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese     children and infants. But the antibody titer against EV71 was found decreased significantly     at month 8 compared to that at day 56. Considering the similar dynamic trend had also been     found in the antibody against poliovirus induced by polio vaccines, and whose immunization     schedule contains a booster dose administrated at 1 to 1.5 year after the first 3 doses of     fundamental immunity. In order to find a better immunization schedule for children, the     investigators decided to perform this booster immunity trial among these children who had     received two doses of EV71 vaccines (around one year after the fundamental immunity). The     investigators do the recruitment among these children who had participated in the previous     phase II trial and received EV71 vaccines, and randomize them in a ratio of 2:1 to receive     either a booster dose of EV71 vaccines or placebo.   "
118539|NCT01734395|"     The purpose of this study is to demonstrate that the change of attention measure is     correlated with the changes of caregiver's burden after treatment with galantamine.   "
118540|NCT01734382|"     PART1 Participants in Part 1 (Run-in-Phase) of study will receive Tocilizumab (TCZ)     (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2     weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during     part 1 may be eligible to move into Part 2 of the study.      PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics,     pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose     frequency in participants with adequately controlled systemic juvenile idiopathic arthritis     who have experienced a laboratory abnormality on twice weekly RoActemra/Actemra dosing, that     has since resolved. Participants will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg     intravenously every 3 weeks. After 5 consecutive infusions, participants who experience an     event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks     RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.   "
118567|NCT01734018|"     This multicenter, prospective, observational study will evaluate the efficacy and safety of     Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive     or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys     according to standard of care and the summary od product characteristics/local labelling will     be followed for the duration of treatment and up to 2 years of follow-up.   "
118541|NCT01734369|"     Background:        -  Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It          can cause muscle weakness, swelling, and pain. It can develop in people with no history          of muscle problems. Environmental exposures may determine who develops myositis. Genes          may also affect development of the disease.        -  Some people who serve in the military develop myositis. However, other military          personnel do not. Researchers want to compare military personnel with and without          myositis. They will look for common factors that might have led to the disease.      Objectives:      - To study environmental risk factors for myositis in military personnel.      Eligibility:        -  Military personnel who developed myositis during their period of service.        -  Healthy military personnel who do not have myositis or another autoimmune disease.      Design:        -  Participants will have a physical exam and medical history.        -  Participants will fill out forms about environmental exposures, particularly while in          the military. The questions will ask about past infections, vaccines and medications,          and personal habits. They will also ask about participants occupations during military          service and their deployments.        -  Participants will also provide blood samples for study.        -  No treatment will be provided as part of this study.   "
118542|NCT01734356|"     The recent developments of research on iPS (induced pluripotent stem) cells lead to the     establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with     genetic and cellular characteristics of the donors. These cells represent a biological     material more readily available to identify the pathophysiological mechanisms involved in the     diseases of BrS or ERS patients, which will lead to the identification of genetic markers.   "
118543|NCT01734343|"     Age-related cataract is the main cause of impaired vision in the elderly population     worldwide.      The only treatment that can restore functional visual ability is cataract surgery where the     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular     lens is implanted into the remaining capsular bag. Cataract operations are generally very     successful, with a low risk of serious complications.      The most common reason for impaired vision after uneventful cataract surgery in otherwise     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a     physiological change (thickening, opacification and clouding) of the capsular bag expected     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that     uses a laser to open a central hole in the posterior capsular bag.      Modifications in IOL design and material lead to a decrease in the incidence of PCO.      During the past two decades, refinements in surgical technique were made resulting in today's     small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are     available, many of them similar but of course with some differences in regard to the chemical     composition of the acrylic material and the IOL design.      The purpose of this study is to compare the development of posterior capsule opacification     (PCO) and the frequency of treatment between two different microincision IOLs over a period     of 3 years.   "
118544|NCT01734330|"     Background: Pharmacological strategies to improve smoking cessation have been largely     studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in     tobacco cessation has not yet been demonstrated.      Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine     replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52     weeks.      Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334     patients. Analysis will follow intention-to-treat principle.      Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year     before randomization will be included.      All of them will receive nicotine replacement therapy with patches and gum. They will be     randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first     six weeks of the treatment. Every two weeks all of the patients will be evaluated by a     physician in order to access any adverse effects from the nicotine replacement.      All patients will have carbon monoxide levels accessed at baseline and after 6 weeks.     Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco     cessation, relapses episodes and abstinence maintenance.   "
118545|NCT01734317|"     Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or     the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or     superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of     3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer     Ag will be used as wound contact layer and gauze rolls and compression as second dressing.   "
118546|NCT01734304|"     The aim of this study is to determine the feasibility and safety of an autologous DC     immunotherapy in patients with AML of non-favorable risk profile.   "
118547|NCT01734291|"     The purpose of this study is to examine the effectiveness of brief multifamily     psychoeducation to relieve the psychological distress of families of patients with chronic     major depression and to improve their family functioning.   "
118548|NCT01734278|"     The purpose of this observational study is to evaluate the use and short term safety of     Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United     Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by     the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the     manufacturer of Sycrest.   "
118549|NCT01734265|"     The primary objective of this study is to evaluate the safety and tolerance of a rush build     up administration of Depigoid forte pollen and the first maintenance dose administered 4     weeks later.   "
118568|NCT01734005|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The     investigators measured decrement of body fat parameters , including Body Fat Mass, Percent     Body Fat, weight and BMI(body mass index), and monitored their blood pressure.   "
118569|NCT01733992|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     R348 eye drops in patients with dry eye disease.   "
118570|NCT01733979|"     The investigators performed a 4-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia.     The investigators measured Improvement of Anemia parameters , including hemoglobin,     transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.   "
118550|NCT01734252|"     Critically ill patients with high risk for thrombosis or tromboembolic events with the     presence of heparin resistance, treated at the Department for General and Surgical Critical     Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when     meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and     is recruited for the study, the patient will be randomized either to Group A or Group H.      All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec     (Pathromtin® SL) within 6 to 8 hours.      Randomisation Group A:      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,     he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be     given and adjusted until the target aPTT-range is achieved.      Randomisation Group H - Standard therapy:      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,     he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary     increased. Hereby the maximum heparin dose is 1.500 IU per hour.      Therapy failure Group H:      Primary target failure at Visit 3 (6-8 hours):      If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch     to Group A and will start with T1 (Baseline) and will follow the visits according to Group A     until the final Visit 9 (T1 / day 30).      Maintenance failure after Visit 3:      Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until     day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to     be changed to Argatroban.      The patient will start with T1 (Baseline) and will follow the visits according to Group A     until the final Visit 9 (day 30) counting from the Baseline of Group A.      Therapy failure Group A:      If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain     the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further     study period, the patient automatically drops out of the study.      The same is effective for patients who switched to the Group A after a therapy failure in     Group H.      General:      Two hours after starting the Baseline investigations, patient's parameters in-cluding blood     collections will be measured for the second time (T2). Additional measurements will be made     at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on     day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30     days after inclusion in the study, a final investigation is planned (T9).   "
118551|NCT01734239|"     The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in     participants from the Russian population who are 50 years of age and older or 2 to 49 years     of age and at increased risk for pneumococcal disease   "
118552|NCT01734226|"     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Prunus Mume Extract on Improvement of     Constipation. The investigators measured Improvement of Constipation parameters , including     Colonic Transit Time, number of bowel movement, defecation time, stool type, color and stool     amounts per defecation, and monitored their blood pressure.   "
118553|NCT01734213|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on     improvement of Cognitive Function. The investigators measured improvement of Cognitive     Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and     BCRS, and monitored their blood pressure.   "
118554|NCT01734200|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on     improvement of Memory Function. The investigators measured decrement of improvement of Memory     Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood     pressure.   "
118555|NCT01734187|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of     body fat. The investigators measured decrement of body fat parameters , including abdominal     fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, and monitored their     blood pressure.   "
118556|NCT01734174|"     Echocardiography is an ultrasound-based imaging technique which can be performed through the     esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are     performed routinely as a monitoring and diagnostic tool at different times in the course of     one cardiac surgery. The purpose of the study is to compare these two methods of     echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely     performed simultaneously. The study will also compare the echocardiography data to a third     technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.   "
118557|NCT01734161|"     Patients who present for scheduled (non-emergent) cesarean section will be given either     intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal     anesthetic. The investigators will then compare the incidence of nausea and vomiting and the     use of rescue anti-nausea medications in both groups. Our hypothesis is that patients     receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section     will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours     following surgery.   "
118558|NCT01734148|"     Sleep is a biological process essential for health. Being hospitalized can exacerbate common     sleep difficulties in children. Factors that contribute to sleep disturbances during     hospitalization include environmental, physiological, and psychological factors. Although     sleep interventions exist for healthy children in the community, interventions aimed at     hospitalized children need to be developed and piloted with rigorous evaluative methods. The     primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO     SLEEP program on hospitalized children. Although this study is a pilot study, comparisons     will be made to examine sleep outcomes between the intervention group and the control group     including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of     nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety     levels and the development of post-hospital maladaptive behaviours.   "
118559|NCT01734135|"     This proposal examines use of a clinical reminder to the primary provider of patient with a     high B type natriuretic peptide but no prior imaging.      Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve     Heart Failure Management in Patients with High BNP Values and Unknown LVEF.   "
118560|NCT01734122|"     The purpose of this study is to determine the changes in quality of life and degree of tremor     for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic     radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed Description     below for more information.   "
118561|NCT01734109|"     Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and     promotes granulation tissue and angiogenesis. Despite these known means for facilitation of     wound management, further research is needed to examine whether this modality is superior to     other currently used options, thus defining clear indications for and benefits of NPWT. This     would also help establish the role of combination therapy, using NPWT with simultaneous     irrigation or other forms of dressings. This study aims to compare treatment efficacy of     NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of     care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is     comparison of reduction of wound volume between the three treatment arms; and secondary     endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.   "
118572|NCT01733953|"     Adult survivors of childhood cancer are at high risk of developing cardiovascular disease.     Therapies used to treat many cancers, such as chemotherapy and radiation, likely cause damage     to the surface of the artery wall called the endothelial layer, leading to the induction of     atherosclerosis and eventual cardiovascular disease. HMG coenzyme A reductase inhibitors, or     statins, improve endothelial function independent of cholesterol-lowering. In addition,     statins have been shown to reduce arterial stiffness and slow arterial thickening. Despite     strong evidence supporting the vascular benefits of statins in many different patient     populations, these medications have never been studied in cancer survivors. Therefore, the     overall objective of this study is to evaluate the effects of statin therapy on vascular     health in young adult survivors of childhood cancer.      Twenty-four young adult (age 18-39 years old) survivors of childhood acute lymphoblastic     leukemia (ALL) or non-Hodgkin's lymphoma (NHL) will be enrolled in a six-month randomized,     double-blind (participants and investigators), placebo-controlled pilot clinical trial     comparing the effects of atorvastatin versus placebo on endothelial function and other     measures of vascular health.      Our primary objective is to evaluate the effects of 6-months of statin therapy on conduit     artery endothelial function in young adult survivors of childhood cancer. The investigators     hypothesize that, compared to placebo, atorvastatin will significantly increase brachial     artery flow-mediated dilation in survivors of childhood acute lymphoblastic leukemia and     non-Hodgkin's lymphoma.   "
118573|NCT01733940|"     Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in     intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can     decrease the catheters colonization, closely related to infection thereof.      Objective: To determine the efficacy of the dressing Tegaderm CHG dressings versus     Tegaderm IV dressings in reducing the risk of colonization of central intravascular     catheters in the intensive care unit (ICU).      Methods: Randomized controlled trial with blinding professional who reviews the main outcome.     The study included patients over 18 years, indicating the central intravascular catheter     implantation in the ICU or in the operating room, prior informed consent. Excluding subjects     with positive blood culture at the time of catheter implantation.      The estimated sample size is 398 patients, with a confidence level of 95% and a statistical     power of 80%. The study protocol was approved by the ethics committee of the hospital.      Be made prospectively followed subjects from study entry until catheter removal collecting     information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site     and removal, reason for withdrawal and microbiological information.      For statistical analysis, a model is adjusted multivariate logistic regression, determining     the interaction of variables with the likelihood ratio test and confusion by switching     between the crude and adjusted effect greater than 10%.      Results and conclusions: The recruitment has started in November 2012 and is scheduled for     completion in March 2013. This study will determine whether these new dressings are effective     in our environment.   "
118574|NCT01733927|"     The purpose of this study, conducted in Santiago-Chile, was to:        1. Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when          compared to ELISA;        2. Track the number of people in the study who returned for their ELISA test HIV results;          and        3. Analyze the perception among participants of the use of OQA compared to ELISA testing          for HIV screening.   "
118575|NCT01733914|"     According to traditional Chinese medical theories, a variety of acupuncture formulas can     treat diseases such as pain. For example, stimulating acupoints either local or distal to the     pain site has been proposed under some conditions. We hypothesize that stimulating acupoints     contralateral to the pain site can successfully treat chronic shoulder pain.   "
118576|NCT01733901|"     To study whether renal sympathetic denervation(RSD) will reduce the all-cause mortality and     the recurrence rate of a composite of cardiovascular event(including angina, myocardial     infarction, repeat percutaneous coronary intervention and coronary artery bypass grafting) in     patients after percutaneous coronary intervention(PCI). Besides whether RSD can reduce the     risk factors for coronary heart disease.   "
118577|NCT01733888|"     Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride     during the tooth development.      The present study is planned to evaluate the efficacy of Resin Infiltration technique in     improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin     infiltration is a novel method that has shown its efficacy in improving the esthetics of     White spot lesions (WSLs) per say and post orthodontics WSLs in different both in-situ and     in-vivo studies. The Resin Infiltration technique is also known to stop the progression of     caries in non cavitated lesions in both, smooth surface and interproximal lesions.      Therefore, the following trial will be conducted to assess the esthetic improvement of     fluorosed permanent anterior teeth after resin infiltration and compare it with standard     bleaching procedure and a combination of bleaching and Resin infiltration therapy in children     with damaged teeth by fluorosis.   "
118578|NCT01733875|"     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral     dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy     subjects   "
118579|NCT01733862|"     This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City     (administrative district), Japan, where RV vaccines have been introduced since November 2011     and financial support for vaccination costs by Nagoya city, Japan have been implemented from     October 2012.   "
118580|NCT01733849|"     This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the     primary care settings of both Bulgaria and Latvia in children less than 5 years of age.   "
118581|NCT01733836|"     To determine whether the use of metformin in patients with low-risk prostate cancer can delay     progression to clinically significant prostate cancer.   "
118622|NCT01733290|"     This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients     with dysfunctional voiding. The results of this study can provide further information for     patient selection and therapeutic duration.   "
118582|NCT01733823|"     P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of     head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and     nimorazole has been shown to improve local control. The purpose of the study i to investigate     the level of co-morbidity and performance status (PS) that allows the combination of all of     the above means of treatment intensification   "
118585|NCT01733784|"     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The     mechanisms that lead to airway closure are not completely understood. Some studies have shown     that there is progressive narrowing of the pharyngeal airway across breaths during expiration     (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The investigators     will assess the viscoelastic properties of the pharyngeal airway and its role in PEN.   "
118586|NCT01733771|"     This study evaluates the effects of complementary medicine (CAM) treatments on patient     reported outcomes in hospital settings, for hospitalized people. Various CAM modalities such     as acupuncture, reflexology, guided imagery and hypnosis are evaluated. The investigators     compare outcomes between two groups: Standard of care (treatments that are provided commonly     in hospital) versus standard of care AND CAM treatments. Outcomes assessed are both     quantitative i.e. scores on Visual Analogue Scale for various symptoms such as pain, nausea,     wellbeing, anxiety, and qualitative such as Measure Yourself Concerns And Wellbeing.   "
118587|NCT01733758|"     This study is designed to examine the efficacy and safety of 2 dose levels of weekly     subcutaneously injected albiglutide compared with placebo and an open label reference arm of     daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes     mellitus.   "
118588|NCT01733745|"     The purpose of this study was to assess the efficacy of the SYSTANE® family of products     (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on     meibomian gland functionality in subjects with lipid deficiency related to evaporative dry     eye as compared to the standard of care warm compresses.   "
118589|NCT01733732|"     The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to     improve comfort in subjects with dry eyes.   "
118590|NCT01733719|"     LAY SUMMARY      A type of gullet cancer (oesophageal adenocarcinoma) has become the 5th commonest UK cause of     cancer death. Unfortunately, by the time patients have symptoms, the cancer is often     incurable. People with Barrett's oesophagus (change of gullet lining occurring in some with     acid reflux) at risk of this cancer can have regular check-ups, involving examination through     an endoscope (an instrument inserted by mouth, under mild sedation if required). A small     proportion of people with Barrett's develop further changes (which might become cancer) in     the gullet lining; if they do, it is important to remove the affected tissue before cancer     develops, or when it is at an early stage.      There are several ways of removing this tissue but the investigators do not know which is     best. The standard treatment is surgery, but there is a small risk of dying from the     operation, and patients often suffer complications affecting them for a year or more     afterwards. Two endoscopic treatments do not involve surgery. Both involve removing visible     abnormalities by a technique called endoscopic resection, followed by cauterising the     remaining Barrett's gullet lining by 1 of 2 techniques. One is recommended by the National     Institute for Health and Clinical Excellence, but it is expensive and less widely available     than the second. No-one has compared these treatments with each other, nor with surgery, in     randomised trials (the most reliable way of deciding which is best). Patient groups say they     would prefer to avoid surgery if the alternative works, and have encouraged us to do trials.      This feasibility study is a vital step towards two trials: (a) a trial to compare the two     non-surgical techniques and (b) a trial comparing surgery with endoscopic treatment. It will     help us find out whether it will be possible to enroll and retain enough patients by using     several centres, and to identify/resolve any other potential barriers to recruitment and     retention, including exploring viewpoints of patients and surgeons.   "
118591|NCT01733706|"     The aim of this study is the evaluation of early smoking reduction or cessation by means of     no nicotine electronic cigarette added to standard counselling.   "
118592|NCT01733693|"     The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two     types of opioid addiction treatment, on the ability to think and reason among people addicted     to opiates, and who are either HIV negative or HIV positive; and (2) investigate whether HIV     infection changes the way opioid treatment affects the ability to think and reason. The     investigators hypothesize that there will be (1) significant improvement in thinking and     reasoning ability after starting buprenorphine treatment compared to methadone treatment,     among participants with and without HIV at 2 and 4 months compared to baseline; and (2) HIV     positive participants will demonstrate significant improvement in thinking and reasoning     ability at 2 and 4 months compared to baseline, but that their thinking and reasoning ability     will still be lower than HIV negative participants.   "
118593|NCT01733680|"     The investigators are proposing to test a medication derived from our prior studies of the     gene SLC9A9. This one gene makes NHE proteins that control how we learn and remember items,     which is impaired in ADHD and may cause an inability to plan, prioritize,     self-monitor,inhibit, initiate, self-correct, or control one's behavior. The investigators     now propose to investigate the therapeutic utility of an NHE inhibitor, amiloride     hydrochloride, for the treatment of attention deficit hyperactivity disorder (ADHD) in     medication-naïve adults with ADHD.   "
118594|NCT01733667|"     The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack     after FESS.   "
118595|NCT01733654|"     The purpose of the study is to explore the efficacy of 6 weeks treatment of an     investigational medication, RO4995819, versus placebo as adjunctive therapy in patients with     major depression.   "
118596|NCT01733641|"     Healthy volunteers without concussion, currently participating in non-or-limited contact     sports teams at Emory University will undergo Display Enhanced Testing for Concussion and     mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and     day 90. Prior to enrollment participants will be allocated to the test-retest arm or the     exercise arm.   "
118597|NCT01733628|"     GEI-BEV-2011-02 is a multicenter, post-authorization observational with prospective follow-up     (EPA-SP) study. Will be involved 137 metastatic breast cancer patients or metastatic     colorectal cancer. The hypertension will be evaluated as a predictor of efficacy of     bevacizumab associated with chemotherapy, in terms of progression-free survival (Main     endpoint).      The duration of the study will be approximately 42 months.   "
118598|NCT01733615|"     The purpose of this study is to find out more about some of the unusual chemicals (called     oligosaccharides) that can occur naturally as a result of processes in the body. Researchers     want to look at how these chemicals change with time and how they change between different     patients with MPSIVA. These unusual chemicals were recently discovered in the urine from     patients with MPSIVA. The investigators would like to study these chemicals before a specific     enzyme replacement therapy is used. If the investigators understand how these chemicals     change, the investigators may be able to use them to monitor this condition in the near     future as well as help doctors know whether certain therapies work well in their patients.   "
118599|NCT01733602|"     The primary aim for the study is to determine whether transcranial direct current stimulation     (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to     determine whether tDCS combined with CT causes larger transferable improvements on     non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are     maintained over time (i.e., maintenance effects).      Specific hypotheses are:        1. CT combined with active tDCS will produce greater training gains on CT tasks compared to          a similar control group receiving CT with sham tDCS.        2. CT combined with active tDCS will produce greater generalisation effects on non-trained          cognitive tasks compared to CT with sham tDCS.        3. The cognitive improvements gained by patients from both interventions will be maintained          over 1 month follow-up.   "
118600|NCT01733589|"     Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the     local control of tumors, especially the squamous cell carcinomas. Preclinical models have     shown that Endostar may transiently normalize the tumor vasculature to make it more     efficient for oxygen delivery, thereby providing a window of opportunity for enhanced     sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and     efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen     in patients with unresectable stage III NSCLC.   "
118601|NCT01733576|"     This project will use a new form of non-invasive brain stimulation called high-definition     transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of     stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more     spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the     brain important for learning and memory will improve verbal learning and memory compared to     sham HD-tDCS.   "
118602|NCT01733563|"     The objective of this study is to investigate the impact of sugar sweetened beverages on the     fat metabolism of healthy young men. It is well known that consumption of beverages sweetened     with fructose is associated with different health risks such as type 2 diabetes. The present     study has been designed to dissect differences in the metabolic pathways of fructose and     glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a     period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened     beverages or continue their usual drinking habits. During these seven weeks there will be     different metabolic investigations using stable isotope tracers. First, the rate of lipolysis     and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be     measured. During all examinations there will also be substrate- and energy-utilization     measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on     the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and     also in the fasting state significantly more than glucose by enhanced expression of lipogenic     enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.   "
118603|NCT01733550|"     The purpose of this study is to compare glaucoma patients' own I Care measurements by the     standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.   "
118604|NCT01733537|"     The purpose of this study is to determine whether providing motorcycle taxi drivers with a     free reflective fluorescent vest will result in increased use of reflective or fluorescent     clothing compared to education about wearing reflective or fluorescent clothing alone.   "
118605|NCT01733524|"     The investigators' long-term goal is to discover novel, inexpensive and feasible strategies     to improve the management and well-being of youth with T1DM. The specific objective of this     proposal is to quantify the impact of responsible pet ownership on the glycemic control and     health related quality of life in youth with T1DM.   "
118606|NCT01733511|"     Emergency departments are established in 20 hospitals in Denmark in order to improve the     quality for the acute patients.      A group of acute patients which require timely assessment and plan from a specialist is     patients with abdominal pain.      the aim of the present study is to evaluate whether the admission of the group of patients to     emergency departments reduces the time to doctor, specialist and plan compared to the     traditional admission to a surgical acute ward.   "
118607|NCT01733485|"     Asthma is an inflammatory disease, which means it causes swelling in the lungs to cause     shortness of breath and/or wheezing. There are several asthma medications that help to reduce     this problem.      The objective of this research study is to characterize the presence of electrophilic fatty     acids in the bronchial airway of subjects with controlled asthma at baseline and after     treatment with Aspirin, Indomethacin, or no treatment at all. The presence of electrophilic     fatty acids may indicate inflammation. Aspirin and Indomethacin are known to respectively     increase and inhibit the formation of electrophilic fatty acids. By gaining a better     understanding of how electrophilic fatty acids work and how they respond to different     treatment, researchers hope to be able to find better ways to lessen airway inflammation in     asthma in the future.   "
118608|NCT01733472|"     The purpose of this study is to determine whether general anaesthesia or regional anaesthesia     is best for patients undergoing Total Hip Arthroplasty.   "
118609|NCT01733459|"     This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with     6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in     improving reproductive parameters and to evaluate the safety of DLBS3233 in women with     polycystic ovary syndrome compared with metformin, as an active control.   "
118610|NCT01733446|"     The investigators data reveal an important new observation regarding the recovery of     breathing during emergence from general anesthesia: respiration resumes as a prolonged     abdominal expiration event.      The present study aims to further clarify the physiology of recovery of breathing with the     addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of     two different recovery paradigms.   "
118625|NCT01732432|"     The purpose of this study is to determine whether a relationship exists between a previously     established diagnosis of endometriosis and the consecutive risk of developing a clear cell or     endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses     (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer     registry data will be assessed to investigate differences in survival of women with     endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without     previous diagnosis of endometriosis.   "
118611|NCT01733433|"     The main goal of this study is to evaluate the effect of taping on postural control during     dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the     study. Several questionnaires regarding anthropometric data, medical history, activity level     and functional status will be filled in by the participants. Postural control will be     measured using a force plate and an optoelectronic system to capture lower limb kinematics.     Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they     have to maintain their balance for 10 seconds after landing. 5 good trials of each movement     will be captured. Subjects with CAI will perform these exercises with and without tape.     Hypothesis is that subjects with CAI that tape will enhance postural control.   "
118612|NCT01733420|"     A clinical trial to evaluate and compare three different products used for endodontic     treatment (taking the infected nerve out of the teeth) of primary teeth.      Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the     former iodoform product.   "
118613|NCT01733407|"     In hereditary sensory and autonomic neuropathy type 1 (HSAN1) the investigators recently     discovered the accumulation of two neurotoxic sphingolipids. It appears that these lipids     arise as the mutant enzyme has a reduced affinity for its normal preferred substrate     L-serine. The investigators now plan to perform a two year study of L-serine supplementation     to correct the biochemistry and neurological disease in humans with HSAN1. In the course the     investigators will also establish correlations between an existing neurological rating scale     of sensory neuropathy and intraepidermal nerve fiber density.      Funding Source - FDA OOPD   "
118614|NCT01733394|"     The United States Food and Drug Administration (FDA) has specific rules which generic drug     companies must follow to get a generic copy of a seizure medication approved. Currently, FDA     approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and     who take just one dose of the generic drug followed by a series of blood tests. Some people     with epilepsy and their physicians have complained about side effects or loss of seizure     control when taking generic drugs, but no one knows if these complaints are truly because of     problems with the generic drugs.      This research is to determine whether several different generic versions and the brand     version of the medication lamotrigine perform in a similar way when given to people with     epilepsy.      The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be     tested are approved by the FDA for the treatment of seizures.   "
118615|NCT01733381|"     Aerobic exercise impacts bodily processes implicated in the pathophysiology of major     depression. Consistent with these effects, aerobic exercise in general, and running in     particular, has been repeatedly shown to have both immediate mood elevating and longer-term     antidepressant effects. To the investigators' knowledge, all studies of running as a     therapeutic intervention for mood have had subjects run in standard running shoes, despite     increasing evidence that running barefoot or in shoes with minimal effect on foot strike     (i.e. minimally shod) leads to marked changes in how people run in ways that might have     physiological effects of relevance to health. Thus, nothing is currently known about     differences in effects on depression-relevant physiological or emotional functioning between     running either barefoot or minimally-shod vs. running in standard running shoes (hereafter     called shoed). The current pilot study is designed to begin addressing these issues by     examining effects of minimally shod vs. shoed running on non-invasive measures of autonomic     nervous system (ANS) functioning and mood state.   "
118616|NCT01733368|"     Optimization and evolution of the patient will be evaluated over 6 months after the implant.   "
118617|NCT01733355|"     [F-18]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the     human brain.   "
118618|NCT01733342|"     To compare the performance of domestic chemoport and imported chemoport   "
118619|NCT01733329|"     Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in     women with risk factors for uterine atony decreases the need for additional uterotonic     medications, uterine atony and postpartum hemorrhage.      Design: randomized, double-blinded, placebo-controlled trial.   "
118620|NCT01733316|"     The purpose of this study is to gather information about the effectiveness (how well it works     to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103, compared     to the already-approved drug cystinosis patients are taking called Cystagon®.      In cystinosis, the body builds up cystine. When taken regularly, the active ingredient of     Cystagon® (cysteamine bitartrate) reduces cystine in the body. RP103 has the same active     ingredient as Cystagon® and is designed to reduce cystine in a similar way that Cystagon®     does. To decide if RP103 is better than Cystagon®, the study will look at two types of blood     tests. One test is pharmacodynamics (PD), which measures the amount of white blood cell (WBC)     cystine after taking study drug. WBC cystine is a laboratory test used to find out if     cysteamine bitartrate is reducing cystine levels in the body. The second test is     pharmacokinetics (PK), which measures the amount of cysteamine in the blood after taking the     drug.      RP103 is different from Cystagon®: Instead of the cysteamine bitartrate being absorbed from     the stomach, RP103 is designed to be absorbed from the small intestine. This may make the     effects of the drug last longer, so that it can be taken twice a day instead of four times a     day like Cystagon®.      Some cystinosis patients have bad breath (halitosis) when they take Cystagon®. Study     participants who experience bad breath with Cystagon® will be asked if they would like to     participate in an optional halitosis substudy to investigate this issue by collecting some     extra PK blood samples.   "
118621|NCT01733303|"     Osteoporosis is a prevalent health concern among older adults and is associated with an     increased risk of falls that can cause fracture, injury or mortality. Identifying the factors     related to falls occurring within this population is essential for the development of     effective regimes for fall prevention. Studies have shown that muscle quality and good     posture alignments are critical for balance control in older adults. People are diagnosed     with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading     vertebral, fractures and poor balance control, even falls. Therefore, improving muscle     quality, strengthening weak muscles and correcting postural alignment are essential elements     for fracture and fall prevention in older adults with osteoporosis. The long-term objectives     of this work are to prevent fracture and fall in older adults with osteoporosis by improving     the function of degenerative muscles using exercise training.   "
118626|NCT01732419|"     Physical exercise training appears effective for low to moderate patients assigned to cardiac     rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity     levels often drop after attending the last supervised rehabilitation session.      This study will compare home based physical exercise training including telemonitoring with     regular centre based physical exercise training. Main outcome measures are the change in     physical activity and the change in physical fitness (peak Oxygen uptake) after the initial     rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are     cost-effectiveness, training adherence, health-related quality of life and patient     satisfaction.   "
118627|NCT01732406|"     The investigators hypothesize that treatment of acromegaly will be associated with an     improvement in quality of life compared to active acromegaly. At the same time, they will     also be studying the effects of different acromegaly treatments on the quality of life.   "
118628|NCT01732393|"     The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and     treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.   "
118629|NCT01732380|"     The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus     radiotherapy in subjects with inoperable esophageal cancer.   "
118630|NCT01732367|"     This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir     monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B     patients with Undetectable Hepatitis B Virus DNA   "
118631|NCT01732354|"     The investigators aim to clarify the issue of adequate duration of consolidation period of     Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a     balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or     virological recurrence.   "
118632|NCT01732341|"     This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system     (Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent     is not worse than the Vision stent.   "
118633|NCT01732328|"     Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium     intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and     maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate     the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of     lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and     neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus     vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth     parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal     bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum     and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.   "
118634|NCT01732315|"     This protocol describes a study about vaccination uptake among adolescents. The purpose of     the study is to determine whether parents who receive email reminders will be more likely to     obtain Tdap (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus),     meningococcal, and influenza vaccines for their adolescent children than parents who do not     receive email reminders.   "
118635|NCT01732302|"     The purpose of this study is to determine whether an educational intervention given towards     health care providers working in primary health care centers can reduce inappropriate     prescribing in the elderly patient and thus reduce number and length of drug-related     hospitalizations as well as number of emergency department visits in this patient group.   "
118636|NCT01732289|"     Age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped     conditions for the elderly. Many factors including genetics, diet, diseases, drugs,     socioeconomic factors and environmental variables were considered to be related to the     development of presbyacusis. Evidences have shown that genetic factors play an important role     on presbyacusis. However, which genes or their genotypes are associated with presbycusis     remain unknown.      The aim of this project was to evaluate the association between the genotype of candidate     genes and presbyacusis by cross-section and case-control study. In the first stage, the     investigators plan to select 700 healthy subjects older than 50 with symmetric, sensorineural     hearing loss. The subjects will receive basic otologic examination, pure tone audiometry,     questionnaire, and genotype analysis. Because gender and age would affect hearing loss     significantly, The investigators will convert the hearing level of all subjects into a gender     and age independent Z-score according to ISO 7029 standard. And, The investigators define     subjects within higher 30 % of Z-score as the presbyacusis group, and subjects within lower     30% of Z-score as the control group. Finally, The investigators perform Chi square analysis     to test the association between genotype of candidate genes or their combinations in both     groups, and calculate the odds ratio for presbyacusis between different genotype of candidate     genes. Further more, we will evaluate the effect of genotype of candidate genes, environment     factors, and gene-environmental interaction on the severity of presbyacusis by multivariate     logistic regression.      In the second stage, The investigators wish to know the pattern of genotype and hearing level     in the high risk families, according to results from the first stage, by description and     case-control study. The investigators will perform t-test to evaluate the difference of     Z-score in both groups. Besides, The investigators try to evaluate the effects of genotypes,     environment factors, and gene-environmental interaction on hearing level in high risk     families by multivariate logistic regression.   "
118651|NCT01733095|"     Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension     and is present in approximately 5% of cirrhotic patients. Treatment options include     prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.      This study investigates the safety and efficacy of ambrisentan in portopulmonary     hypertension.   "
118652|NCT01733082|"     The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry     collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes,     fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be     solicited at selected gestational time points. Structural and functional birth defects     identified in the perinatal period through one year of life will be collected and classified.      This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk     Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all     mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.   "
124696|NCT01653509|"     This study will treat approximately 24 participants who experience cold sores. Patches will     be applied to the cold sore for up to ten days, and the symptoms will be measured during     daily clinic visits using non-invasive measurement techniques.   "
118653|NCT01733069|"     The objectives of this study are to establish the performance characteristics of the AC2     (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the     TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and     reproducibility of the AC2 Assay on the PANTHER System.   "
144308|NCT01395524|"     The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of     opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.   "
118637|NCT01732276|"     Breast cancer is a heterogeneous disease and can be classified into several distinctive     subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER),     progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2)     overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its     aggressive clinical behavior and insensitivity toward available targeted treatment strategies     such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early     relapse with metastatic disease is common and the prognosis is poor. Development Of novel     treatment strategies is,therefore,needed and the study of other potential targets in     TNBC,like tyrosine kinase receptors,is a topic of interest.      Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that     encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the     HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates     cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a     poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene     expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs     exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR     mutation was rare in TNBC.      By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC     has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one     or more limitations including:1) the study population had received heavily pretreatment;     2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR     was not clear in the enrolled patients.      Here, the investigators launch a prospective clinical trial, and about 50 patients with     triple-negative,EGFR positive metastatic breast cancer that have received at least second     line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity     and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in     the metastatic TNBC.   "
118638|NCT01732263|"     The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is     absorbed by the body and how long it takes to be eliminated from the body in healthy subjects     and subjects with mild, moderate, and severe hepatic (liver) impairment compared with     subjects with healthy normal liver function.   "
118639|NCT01732250|"     The purpose of this study is to determine whether the addition of meropenem to colistin is     better than colistin alone in the treatment of clinically significant infections caused by     multi-drug resistant bacteria   "
118640|NCT01732237|"     The purpose of the study is to investigate the pharmacokinetics (what the body does to the     medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single     oral dose of 100 micrograms under fasted conditions in healthy male participants.   "
118641|NCT01733238|"     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study     is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to     characterize anti-tumor activity and collect safety data on patients with relapsed or     refractory lymphoma.   "
118642|NCT01733212|"     SPECIFIC AIMS        -  Assess risk factors for nausea and vomiting in c-section patients undergoing regional          anesthesia        -  Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in          the ginger and placebo groups.        -  Quantify post-operative analgesia and pruritus in the ginger and placebo groups        -  Quantify patient satisfaction of the ginger and placebo groups        -  Assess patient expectation of ginger on post-op day three   "
118643|NCT01733199|"     This study is composed of a main study and an ancillary one. The objective of the main study     is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the     predictive factors for developing a behavioural addiction (BA) secondarily to the     dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in     patients with Parkinson's disease.      3 particular profiles of patients will be established:        -  BA- : no secondary behavioural addiction        -  BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome        -  BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome      We wish in particular:        -  To differentiate, among the BA+ subjects, those for who is a DDS from those for who we          can evoke a side effect of the dopaminergic treatment        -  To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities          causing the occurrence of the BA.        -  To clarify the possible relationship between the dosage and the pharmacodynamics of the          treatment (especially that of pramipexole) in one hand, and the developing of BA in the          other hand.        -  Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability          (related to the dopamine system), originally from the occurrence of the BA.      This study has several levels of evaluation, we chose describe the methodology of the study     in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis.      The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary     study centered on the pharmacokinetic of the pramipexole (in its immediate release form).   "
118644|NCT01733186|"     The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is     safe and effective in the treatment of articular cartilage defects of the knee as a result of     ageing, trauma, or degenerative diseases.   "
118645|NCT01733173|"     The purpose of this study is to better understand why some children with cancer have     difficulty speaking after brain surgery. Difficulty speaking may be due to known     complications to the language centers in the brain. These language centers may be located in     slightly different places in different people. This study will study which areas may be     damaged.   "
118646|NCT01733160|"     This observational registry will characterize contemporary stroke prevention in Canadian     adults with atrial fibrillation, and provide clarity in understanding physician preferences     for the various oral anticoagulants available in the Canadian marketplace. This study will     determine the patient profiles of those selected for the various therapies available in     Canada and provide an understanding of the factors involved in drug selection and management.   "
118647|NCT01733147|"     Will oral supplementation with Omega 3 free fatty acids in obese Barrett's esophagus subjects     downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to     anti-inflammatory pathway?   "
118648|NCT01733134|"     Patients being hospitalized for acute heart failure and already receiving standard therapy     will be randomized to receive either tolvaptan or placebo, based on the level of copeptin     measured in their bloodstream. Patients with high copeptin levels will be able to participate     in the trial, patients with low levels will be excluded. Patients being admitted to the     observation unit for acute heart failure and already receiving standard therapy will be     randomized to receive either tolvaptan or placebo without consideration of the copeptin     level. The hypothesis is that patients receiving tolvaptan will have better improvement of     shortness of breath than those receiving placebo, within 9 hours of drug administration.   "
118649|NCT01733121|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854     (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily     for the treatment of Tardive Dyskinesia (TD) symptoms.   "
118654|NCT01733056|"     Biomedical Lay Summary Title: Characterization of immune response to vaccination in patients     receiving single-drug immunosuppressive therapy Principal Investigator: Robert Swerlick, MD     Other Investigators: Rafi Ahmed, PhD Suephy Chen, MD Jens Wrammert, PhD Adam Sperduto        1. Problem of Interest We are proposing to study the effectiveness of vaccines in people          who are taking drugs that affect the immune system. There are many populations of people          who have chronic medical conditions that require them to have long-term treatment with          immunosuppressive medications (drugs that decrease the function of the immune system).          Examples of these patients include organ transplant recipients, patients with immune          cell cancers such as leukemia and lymphoma, patients with inflammatory disorders such as          lupus or scleroderma, and patients with skin conditions requiring steroid-based creams,          ointments, pills, or injections. Patients who are taking these medications should          receive appropriate vaccinations such as tetanus boosters, influenza vaccines, and          pneumonia vaccines. The effectiveness of vaccinations depends in large part on a strong          response to the vaccine by the immune system. Drugs that decrease immune system function          therefore, may also decrease the effectiveness of vaccines.        2. How the Problem of Interest will be studied      We plan to give three different groups of participants influenza vaccinations and measure     each participant's immune system response through blood tests. The three groups will be:        1. Healthy people taking no immunosuppressive medications        2. Patients with skin conditions requiring treatment with azathioprine and currently taking          no other immunosuppressive agents        3. Patients with psoriasis requiring treatment with TNF-alpha (tumor necrosis factor-alpha)          and currently taking no other immunosuppressive medications.      All participants will be between 18 - 89 years old and will not have had influenza     vaccination within the previous six months. We will administer the vaccination on day 0. We     will take blood samples on days 0, 7, and 28 following vaccination. We will use these blood     samples to measure the amount of antibodies produced to the vaccine and the response of     specific immune system cells known as B-lymphocytes. Using statistical methods, we will     compare these findings between the three groups of participants to determine if differences     in response to the vaccination exist.      3. How the research will advance scientific knowledge and/or human health To our knowledge     there is no scientific data available regarding the effectiveness of vaccinations in patients     receiving only one specific immunosuppressive medication. We will also be using new     techniques developed at Emory to measure the B-lymphocyte response to the vaccine. This     research could potentially help guide vaccination strategies for people requiring     immunosuppressive medications and prevent infectious disease in these populations as well as     the general population.   "
118655|NCT01733043|"     The objective of this study is to determine the effect of dexmedetomidine infusion on the     Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep     apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with     obstructive sleep apnea (OSA).   "
118656|NCT01733030|"     PROJECT SUMMARY:      PTSD is a debilitating psychiatric condition precipitated by exposure to extreme, or life     threatening, trauma with an estimated lifetime prevalence between 8% and 9% in U.S. adults.     One core symptom of PTSD is intense psychological distress in the presence of stimuli that     resemble one or more aspects of the trauma experience (DSM-IV). This phenomenon referred to     as stimulus generalization has received surprisingly little empirical testing in the context     of clinical anxiety in general, and PTSD more specifically. The current proposal represents     the first effort to study the neurobiology and pharmacology of this PTSD-relevant learning     phenomenon across those with and without PTSD. The objective of this particular proposal is     to apply fMRI and pharmacologic methods to: 1) identify brain mechanisms associated with     generalization of conditioned fear and 2) examine the pharmacologic modifiability of levels     of generalization using a partial agonist at the NMDA receptor complex (D-cycloserine) shown     to increase discrimination of CS+ (danger cue) and CS- (safety cue) in animal studies.   "
118657|NCT01733017|"     The purpose of is to test the effects of a 6-month nutrition intervention of dietary sodium     reduction combined with supplementation of lycopene and omega-3 fatty acids on heart failure     symptoms, health-related quality of life, and time to heart failure rehospitalization or     all-cause death.   "
118658|NCT01733004|"     This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3     design, evaluating MM-141 at varying dose levels and frequencies.   "
118659|NCT01732991|"     The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the     treatment of benign prostatic hypertrophy (BPH) as recommended.      The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The     underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal     effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced     ultrasound the necrosis.   "
118660|NCT01732978|"     The crying baby is a sound signal including information relating to this individual identity     or related to its physiological or motivational state.      The objective of the study is to determine the implementation of the recognition of     individual tone of the baby by his parents and acoustic modulation of the baby based on     parental response.      The detailed study of the acoustic structure of crying and analysis of parental perception     will determine the dynamics during the first weeks of life of this recognition, and the     influence of factors such as parental presence, or breastfeeding .      For this study is organized in three stages: first, the recording of the baby's crying     Secondly, a listening test parental soundtracks and third analysis of the acoustic structure     of crying and parental response.   "
118661|NCT01732965|"     To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is     more effective than narrowband ultraviolet B alone in the treatment of vitiligo.   "
118662|NCT01732952|"     This cross-sectional, non-interventional, and observational study will assess the lipid     profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients     achieving treatment to goal according to national and international lipid management     guidelines) during a single visit to their physicians on an outpatient basis in 6     representative geo-economic regions in China: Northeast, North, East, South, Southwest, and     Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching     hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community     hospitals/health centers). The investigators will primarily be cardiologists,     endocrinologists, neurologists, gerontologists, internists, or other physicians who are     representative of the general population of physicians managing patients with dyslipidemia     and/or at high risk for cardiovascular events likely to be treated with lipid-modifying     drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and     cardiovascular treatments will be documented in a single visit through patient clinical     examination and chart review.      DYSIS-China is part of a string of epidemiological studies that share the same master     protocol, which has been conducted in different countries mainly in Europe and Canada. The     analysis of the pooled studies including overall data and cross-country comparisons is the     subject of a distinct protocol.   "
118663|NCT01732939|"     The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for     invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus     taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.   "
119016|NCT01728103|"     The objective of this study is to obtain female first-catch urine, vaginal, cervical and     endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and     TIGRIS® Systems.   "
118664|NCT01732926|"     The primary objective of this study is to evaluate the addition of idelalisib to     bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated     indolent non-Hodgkin lymphoma (iNHL).      An increased rate of deaths and serious adverse events (SAEs) among participants with     front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in     combination with standard therapies was observed by the independent data monitoring committee     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data     and terminated this study in agreement with the DMC recommendation and in consultation with     the US Food and Drug Administration (FDA).   "
118665|NCT01732913|"     The primary objective of this study is to evaluate the effect of the addition of idelalisib     to rituximab on progression-free survival (PFS) in adults with previously treated indolent     non-Hodgkin lymphoma (iNHL).      An increased rate of deaths and serious adverse events (SAEs) among participants with     front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in     combination with standard therapies was observed by the independent data monitoring committee     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data     and terminated this study in agreement with the DMC recommendation and in consultation with     the US Food and Drug Administration (FDA).   "
118666|NCT01732900|"     The purpose of this study is to determine the performance of a genetic assay, GemART, in     cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in     vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as     measured by the implantation rate of embryos transferred.   "
118667|NCT01732887|"     In this study we are testing computer-based brain fitness exercises. The games are designed     to improve people's cognitive abilities brain functions, like memory, concentration, and     ability to do two things at once. We are testing whether this cognitive training brain     exercises will improve understanding of spoken sentences speech comprehension in people who     use cochlear implant and/or hearing aids. We predict that cognitive training will improve     speech comprehension in cochlear implant and/or hearing aid users.   "
118668|NCT01732874|"     The purpose of this research study is to find out whether preterm infants are receiving     enough of the essential and long chain fatty acids important for brain development and immune     function. Our current intravenous (IV) fats do not contain the long chain fatty acids and     different milk sources have different compositions. We would like to evaluate lactating     mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of     their blood and breastmilk samples after they have been supplemented with a currently used     fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM)     Nutritional Lipid) The DHA supplement is available over the counter.      The information learned from this research study may benefit other mothers and babies in the     future. The information could help make sure premature babies are receiving the right     nutrients they need for appropriate growth and development.   "
118669|NCT01732861|"     This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine     a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated     Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the     combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).   "
118670|NCT01732848|"     The purpose of this study is to determine the rate of kidney or heart impairment, if any, in     subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials   "
118671|NCT01732835|"     This investigation is a prospective, non-randomized, multi-center trial to evaluate the     extended safety and performance of the HAART model 300 annuloplasty ring when used to     surgically repair the aortic valve using a 3-D intra-annular mounting frame.   "
118672|NCT01732822|"     The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients     with Peripheral Artery Disease.   "
118673|NCT01732809|"     The purpose of this study is to assess the fields of effect (FE) of ABO and ONA at the same     labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.   "
118674|NCT01732796|"     The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically     infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.   "
118675|NCT01732783|"     This is a multicenter, observational prospective cohort study in France and Germany.     Treatment centres with a focus on treating subjects with mCRC will be prospectively defined     for potential inclusion in the study. Eligible subjects will be enrolled and have     retrospective data collected from Baseline up to the point of enrolment. All subsequent     chemotherapy cycles and Vectibix® doses will be recorded prospectively. Each subject will     have data collected until approximately 30 days after the end of Vectibix® treatment, death,     withdrawal of consent, loss to follow-up or up to 12 months from the first dose of Vectibix®,     whichever occurs first.   "
118676|NCT01732770|"     This study will compare the effectiveness of denosumab treatment every 6 months with once     yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.   "
118677|NCT01732757|"     This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™     (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular     itching associated with allergic conjunctivitis.   "
118678|NCT01732744|"     To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of     complete denture biofilm, comparing it with two products available on the market (sodium     hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were instructed     to brush their dentures after meals and once a day, for a period of 07 days, immerse them in     the following solutions: A - Control: Physiological solution(20 minutes). B - Polident     alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor bean-based     solution(20 minutes). The participants immersed their dentures in each of the solutions,     according to a randomized sequence. For biofilm quantification, before (Baseline) and after     the use of each product, the internal surfaces of maxillary complete dentures were revealed     (1% neutral red), photographed and the stained biofilm was quantified with the aid of     software (Image Tool 3.0). After concluding measurements of the areas (total and biofilm),     the percentage of surface covered by biofilm of the complete denture was calculated .   "
118680|NCT01732718|"     The purpose of this research study is to learn about the effect of the drug, atorvastatin, on     blood vessels in patients with sickle cell disease.      The primary hypothesis is that endothelial dysfunction is an important contributor to the     pathophysiology of albuminuria in SCD. The investigators propose that atorvastatin will     improve endothelial dysfunction, decrease levels of sFLT-1, and decrease albuminuria in SCD     patients.      Participants will be individuals with sickle cell disease, age 18 to 60, who have some degree     of albuminuria. A total of 19 subjects, males and females, will be enrolled. The study is     made up of Screening, Treatment, and Follow Up phases and has a cross-over design. After     patients are screened for eligibility, they will be randomized to receive atorvastatin or     placebo in the initial six-week treatment period. When that is complete, there will be a     four-week washout period before they begin another six-week treatment period. In the second     treatment period, they cross-over to the other treatment arm. Four weeks after the end of     the second treatment period, follow-up safety assessments will be done.   "
118681|NCT01732705|"     The purpose of this study is to determine the effect of High Intensity Interval Training     (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.   "
118682|NCT01732692|"     To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5     colon segments prior to colonoscopy.   "
118683|NCT01732679|"     A descriptive study of the stroke rehabilitation content in specialized clinics in seven     countries: procedures for admission to rehabilitation, services available and provided to     patients, as well as duration of the stay and discharge routines. An observational study of     changes in regard to the physical function, quality of life and psycho-social factors in     stroke patients before and after specialized rehabilitation   "
118684|NCT01732666|"     Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined     as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is     a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was     reported to occur after surgery when large amount of remifentanil was administered. On the     other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to     have analgesic and anti-hyperalgesic effect.      The investigators hypothesized that nefopam administration could prevent OIH or reduce the     severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam     on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.   "
118685|NCT01732653|"     The proposed randomized controlled trial will evaluate the effects of treadmill training     augmented with virtual reality on fall risk.      300 older adults with a history of falls will be recruited to participate in this study. This     will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and     patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the     intervention group (treadmill training with virtual reality) or to the active-control group     (treadmill training without virtual reality). Each person will participate in a training     program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take     place before, after, and 1 month and 6 months after the completion of the training.   "
118686|NCT01732640|"     Trial Objectives:      The objective is to investigate the efficacy and safety of afatinib with induction     chemotherapy in primary unresected patients with locally advanced, HPV-negative, stage III or     IVa/b HNSCC including oral cavity, oropharynx, hypopharynx, or larynx.      Primary Objective Phase I The primary objective of the phase I portion of the trial is to     determine the maximum tolerated dose (MTD) or the recommended phase II dose of daily oral     afatinib that is safe in combination with carboplatin AUC 6 and paclitaxel 175mg/m2 q 21 days     as an induction regimen.      Primary Objective Phase 2 The primary objective of the phase 2 portion of the trial is to     estimate the objective tumor response rate and toxicity with induction therapy in patients     treated on the afatinib dose determined in Phase I.      Secondary Objectives The secondary objective of phase II is to estimate: 1) the overall     response to entire treatment after completion of CRT, 2) progression-free survival (PFS) rate     at 2 years, and 3) overall survival (OS) at 2 years.   "
118687|NCT01732627|"     Primary objectives:        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,          measured by serum bactericidal assay using human complement (hSBA) and baby rabbit          complement (SBA-BR), induced by a single dose of MenACYW conjugate vaccine or Menomune®          - A/C/Y/W-135.        -  To describe the safety profile of a single dose of MenACYW conjugate vaccine or          Menomune® - A/C/Y/W-135.   "
118688|NCT01732614|"     This trial seeks to prove that sub-lethal laser power levels are as effective and less     damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of     diabetic patients with a disease duration of 20 or more years and is one of the most frequent     causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study     (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of     clinically significant macular edema, reducing the incidence of vision loss by approximately     50% at 3 years' follow-up.   "
118689|NCT01732601|"     This study will identify the effectiveness of an intensive treatment program for teens who     are at high risk for harming themselves.   "
118690|NCT01732588|"     The purpose of this study is to determine the bioavailability of nanoparticulate OZ439     delivered to the proximal small bowel (PSB) via the Enterion™ capsule relative to oral OZ439     suspension (current powder in bottle [PIB]) and oral nanoparticulate OZ439.      The study will also characterise the plasma concentration time profile of OZ439 when     delivered via Enterion capsule to the PSB in comparison with OZ439 PIB formulation delivered     orally and nanoparticulate OZ439 delivered orally Safety and tolerability of OZ439     formulations will be determined following delivery to the PSB and administered orally   "
118699|NCT01732471|"     This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of     response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years     who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal     to 450 micromole per liter.   "
119086|NCT01727180|"     We believe that knowing characteristics of uremic pruritus is the foundation to investigate     its pathophysiology and offer better skin care for patients with chronic kidney disease. We     therefore conducted this cross-sectional study to evaluate the characteristics of uraemic     pruritus.   "
118691|NCT01732575|"     This RCT study addresses the topic of improving the possibilities for people with severe     mental illness (SMI) to be engaged in meaningful daily occupations at community-based     activity (CBA) centers. Meaningful occupation, which includes not only work-related     activities, but also leisure, household and social activities, is assumed to generate health     and wellbeing. It is well established that there is a relationship between satisfaction with     daily occupations and well-being.      A Swedish mental health care reform stated that the social services should provide meaningful     daily occupations to people with SMI. However, evaluations of the effects of the reform     conclude that the target group's needs for meaningful daily occupation have not been met.      Thus, on the basis of governmental reports and evaluations, there is an urgent need for     improving the quality of the activities and support offered at CBA centers. Therefore, the     overarching aim of this project is to develop and implement an intervention method for     improving the activities offered and support given at CBA centers, and evaluate the outcomes     of that intervention.      Specific aims        -  Developing and implementing an intervention that means reorganization of CBA centers in          such a way that they become enriched with characteristics that have been identified as          rewarding and meaningful in previous research.        -  Evaluating the outcome of that intervention on:             -  the unit level, i.e., in terms of changes in the characteristics of the CBA               centers,             -  the individual level, in terms of changes among the consumers regarding               satisfaction with the activities at the CBA center, perceived control, social               interaction, quality of life, etc.      Cluster randomization is used. Day centers are randomized to either giving the new     intervention (enrichment) or continuing with care as usual during the study period, which     is 14 months. This means that all participants in a day center get the type care their     specific day center offers during the study period.   "
118692|NCT01732562|"     Patients from the Joint Replacement Institute scheduled to undergo primary total knee     replacement surgery (TKR) will be invited to participate at the Pre Admission Clinic (PAC),     University Hospital, London Health Sciences Centre. Baseline questionnaires of preoperative     measures and demographic information and a cost analysis will be explored at the PAC for each     patient. Patients will be randomized with the treatment group receiving access to a     web-based, e-learning intervention. Postoperatively all patients will be asked to complete     questionnaires at 6 weeks, 3 months and 1 year after their TKR surgery.      Objectives      The first primary objective is to compare the effect of two methods of providing patient     education on expectations of surgical outcome in total knee replacement (TKR) patients.      The second objective is to compare the effect of two methods of providing patient education     on satisfaction with surgical outcome in TKR patients.      The intervention of interest is an e-learning education program that spans both the     preoperative and postoperative time period. The control condition will be the current method     of patient education provided at the hospital study site.      Hypothesis: Objective One      More change in patient expectations will occur between preoperative and one year     postoperative in the e-learning educational intervention group.      Hypothesis: Objective Two      More change in patient satisfaction will occur between preoperative and one year     postoperative in the e-learning educational intervention group.   "
118693|NCT01732549|"     The purpose of this study is to confirm that tasquinimod used as maintenance therapy is     active and tolerable in patients with metastatic castrate-resistant prostate cancer not     progressing after a first chemotherapy with docetaxel.   "
118694|NCT01732536|"     The purpose of the study is to determine whether a steroid-eluting sinus implant is effective     in improving chronic sinusitis symptoms in patients who experience recurrent blockage of the     sinuses by polyps sometime after sinus surgery.   "
118695|NCT01732523|"     Atherosclerosis is a chronic, systemic and progressive disease affecting different arterial     blood vessels in the body. Atherosclerotic lesions silently progress from small plaques to     severe stenosis and may remain asymptomatic for years. Unstable plaques and stenosis (also     called vulnerable plaques), however, are prone to rupture leading to myocardial infarction,     or stroke. The proliferation of the small arteries that are distributed to the outer and     middle coats of the larger blood vessels (vasa vasorum) and within the atherosclerotic     plaques (neovascularization) are inherently linked with the atherosclerotic plaque     development, plaque inflammation and vulnerability. By injecting ultrasound contrast agents     (microbubbles) into the blood stream, it is possible to detect this microcirculation of the     vessel wall and the neovascularization within the atherosclerotic plaque using a     contrast-enhanced ultrasound (CEUS) imaging technique. Particularly, CEUS of the carotid     artery has been introduced as a non-invasive technique to improve detection of carotid     atherosclerosis and to evaluate the presence of carotid plaque neovascularization which has     emerged as a new marker for plaque vulnerability. The project investigates the predictive     value of the detection of carotid plaque neovascularization on CEUS imaging in patients with     asymptomatic carotid artery stenosis regarding the progression of the carotid atherosclerotic     lesion and future vascular events including myocardial infarction, stroke or vascular     intervention. The investigators hypothesize that neovascularization within the carotid lesion     will significantly be more pronounced in patients with progressive carotid lesions and in     patients suffering future vascular events during. The project will support the concept that     intraplaque neovascularization is associated with plaque instability and vulnerability and     therefore, the use of CEUS may provide an additional non-invasive, simple, safe, and reliable     imaging modality to risk stratify individuals. The identification of vulnerable that are at     increased risk of rupture by identification of intraplaque neovascularization is expected to     improve the prediction of future vascular events and thus allow for better treatment     selection. It will help the clinician to further risk stratify carotid stenosis.     Particularly, it will help to identify unstable carotid stenosis that may already benefit     from invasive therapy as carotid thromboendarterectomy and stenting.   "
118696|NCT01732510|"     This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK),     pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe     atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum     tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to     determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define     safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies.     The study was terminated early due to business reasons on 08 May 2014; final results from an     analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety,     immunogenicity) are summarized.   "
118697|NCT01732497|"     The purpose of this study is to evaluate hair reduction in the underarms in patients treated     with the miraDry System.   "
118698|NCT01732484|"     Age-related cataract is the main cause of impaired vision in the elderly population     worldwide. In the UK, more than half of people who are over 65 have some cataract development     in one or both eyes. The only treatment that can restore functional visual ability is     cataract surgery where the opacified crystalline lens is removed by phacoemulsification and     an artificial intraocular lens is implanted. It is estimated that around 10 million cataract     operations are performed around the world each year. Cataract operations are generally very     successful, with a low risk of serious complications. The most common risk is developing a     condition called posterior capsule opacification (PCO), which causes impaired vision to     return.      During the past two decades, cataract surgery underwent tremendous change and modernisation     resulting in today's small incision phacoemulsification surgery and a safe technique with a     short rehabilitation time for the patient. The most frequent long-term complication of     cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,     refinements in surgical technique and modifications in IOL design and material have led to a     decrease in the incidence of PCO.      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial     cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule     opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic     towards the end of the production process, also called multipiece designs.      For several reasons such as better ease of use with injector systems and higher efficiency in     the production process, companies have developed IOLs with open-loop haptics out of one block     of material, also called single-piece designs. In the case of such single-piece IOLs, the     haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick     haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending     effect of the posterior capsule around the posterior optic edge. Additionally, the posterior     sharp edge is often discontinuous in the region of the haptic-optic junctions. These     locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO.     Nowadays a multitude of different single piece IOLS are available, many of them similar but     of course with some differences in regard to the chemical composition of the acrylic material     and the IOL design.      The purpose of this study is to compare the intensity of posterior capsule opacification     (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)     over a period of 3 years.   "
118701|NCT01732224|"     The relevant data will be prospectively collected included patient demographics, clinical,     all laboratory variables including virological tests, genotyping by direct sequencing,     abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy     (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not     evident whether the underlying liver disease was chronic based on clinical, biochemical,     radiological investigations, and upper GI endoscopy. Severity of the liver disease will be     assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD)     score.   "
118702|NCT01732211|"     The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in     subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care     therapies.   "
118703|NCT01732198|"     Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with     Prevnar 13® over a 28 day period following the injection compared to a single booster of     ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.      Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single     booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of     ActHIB® co-administered with Prevnar 13®.      Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®     following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to     the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days     following injection.   "
118704|NCT01732185|"     The aim of this study is to identify genetic abnormalities and molecular pathways associated     with the occurrence of CCAM.   "
118705|NCT01732172|"     Men following after proven and treated urethritis, looking for signs of chronic genital     inflammatory syndrome with oxidative stress.      This group of patients will be compared to a control group with no urethritis and no history     of urogenital infection. Monocentric, prospective trial.      Duration of study : one year   "
118706|NCT01732159|"     The purpose of this study is to evaluate the impact of a check list on the rate of late     cancellation, i.e. the day before or the day of the ambulatory surgery.   "
118707|NCT01732146|"     The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve     survival and neurologic outcome in asphyxiated term newborn undergoing cooling.   "
118708|NCT01732133|"     Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric     measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could     help to detect hypotension.   "
118709|NCT01732120|"     The purpose of this research study is to compare the effects on kidney function after     performing the removal of a kidney tumor with or without clamping the blood vessels during     surgery.   "
118710|NCT01732107|"     This trial will assess the 6-month complete response rate and toxicity profile of oral     dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3     mutations or over-expression who are ineligible for or refusing cystectomy.   "
118711|NCT01732094|"     The purpose of the present study is to examine the level of ovarian response and the     pregnancy rates among poor ovarian responders treated with a novel treatment protocol with     150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.   "
118712|NCT01732081|"     It is estimated that 350-400 million people worldwide are chronically infected with hepatitis     B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV     infection and are responsible of about 500,000 deaths each year. Although some predictive     factors of the outcome of chronic HBV infection were reported, it remains needed to more     precisely determine the factors which are associated with the outcome in non-selected     patients. Indeed, these factors should help to identify patients who are likely to have a     better or worse evolution of their chronic HBV infection over time and thus, to adapt their     clinical management and monitoring.Therefore, our purpose is to constitute a real-life     cohort of non-selected patients to create a database of epidemiological, clinical,     biological, virological and therapeutic parameters, in order to determine factors associated     with the outcome of chronic HBV infection.   "
118713|NCT01732068|"     The purpose of the present study is to examine the level of ovarian response and the     pregnancy rates among poor ovarian responders treated with a novel treatment protocol with     150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.   "
118714|NCT01732055|"     Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy     (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for     Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH)     Perinatal Psychiatry Program.      Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a     depressive episode, and their partners.      Methods: Women and their identified partners will complete a diagnostic interview, complete     measures of depressive symptom severity at baseline, and be randomized to treatment with     PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the     UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of     a number of antidepressant medications, tailored to the individual, although some women may     opt against medication altogether and still be eligible to enroll). Women randomized to     PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week     period, along with one refresher session at or around 6 weeks postpartum. Women and partners     will be assessed for change in depressive symptoms and relationship satisfaction during     pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.      Hypothesis: The investigators anticipate notable improvement in both groups similar in     magnitude, however it is hypothesized that couples participating in PA-IPT will have higher     relationship satisfaction post-treatment (controlling for baseline satisfaction) than those     receiving TAU.   "
118715|NCT01732042|"     Determinate the standard values of the retinal venous pressure in a cohort of healthy     subjects.   "
118727|NCT01731886|"     The study is being done to compare the combination of lenalidomide and dexamethasone followed     by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and     dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will     include how the subjects respond to each study treatment combination, and what side effects     are caused by each combination.   "
118716|NCT01732029|"     Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation (SpO2).     In developing countries, pulse oximeters are rare because of expense and electricity     requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone (which     are widely available in developing countries) to compute and analyze information from a pulse     oximeter sensor. To further reduce costs, we have developed an oximeter sensor (AudioOx) that     plugs into the audio jack of a standard cell phone. This study aims to calibrate the AudioOx     by exposing 30 healthy adult volunteers to various altitudes in UBC's hypoxia chamber.   "
118717|NCT01732016|"     Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation (SpO2).     In developing countries, pulse oximeters are rare because of expense and electricity     requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone     (widely available in developing countries) to compute and analyze information from a pulse     oximeter sensor. To further reduce costs, we use the integrated flashlight of a cell phone's     camera to extract SpO2 (Camera Oximeter), eliminating the need for external hardware. This     study aims to calibrate the Camera Oximeter by exposing 30 healthy adult volunteers to     various altitudes in UBC's hypoxia chamber.   "
118718|NCT01732003|"     The biological membranes that surround a cell and its organelles are vital to the overall     function of the cell. Fatty acids are the main structural component of membranes, and the     presence of specific fatty acids can alter a membrane's characteristics, which subsequently     alters function. Two fatty acids that are of particular interest to researchers are     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). These omega-3 fatty acids have     unique unsaturated structures, and their incorporation into biological membranes appear to     elicit potent physiological effects. The body is unable to intrinsically synthesize these     important fatty acids, so they must be obtained from the diet or through supplementation.      Compared to research investigating other body tissues, the effect of EPA and DHA on skeletal     muscle membranes and cellular function has received little attention. Of the studies done,     EPA and DHA supplementation consistently results in increased EPA, DHA, and total omega-3     fatty acid content in the skeletal muscle membranes of rodents. One study has also     demonstrated this effect in humans. These studies, however, have been limited to whole muscle     measurements, yet cells contain numerous subcellular membranes with diverse functions. Two     membranes of key importance to the metabolic function of a skeletal muscle cell are the     membrane that surrounds the cell (plasma membrane), and the membrane that surrounds the     mitochondria.      The plasma and mitochondrial membranes are responsible for taking up nutrients and converting     them into useable energy for the muscle. Recent findings suggest that physiological changes     in these processes may occur following EPA and DHA supplementation. At rest and during     exercise, there is potential for a shift in substrate selection that favors fat utilization     following EPA and DHA supplementation. Several membrane proteins are responsible for     transporting fat into the cell and mitochondria. The presence of EPA and DHA within membranes     has the potential to affect the membrane integration and function of proteins. The     investigators aim to determine whether fat utilization increases following EPA and DHA     supplementation, and if there is a concurrent change in the concentrations of fat transport     proteins within plasma and mitochondrial membranes. Supplementation with EPA and DHA may also     affect oxygen consumption, an important process in energy production that is regulated by     mitochondrial membrane proteins. Evidence from human and rodent studies shows a decrease in     whole body oxygen consumption following supplementation. The investigators aim to examine     these changes directly by measuring mitochondrial respiration following EPA and DHA     supplementation.      Therefore, the primary purpose of this study is to examine how plasma and mitochondrial     membrane fatty acid composition change individually in response to EPA and DHA     supplementation in humans. The secondary purpose of this study is to examine functional     metabolic changes that occur in skeletal muscle in response to EPA and DHA supplementation,     and to investigate correlational relationships between these changes and any compositional     alterations in plasma and mitochondrial membranes. The investigators hypothesize that     supplementation with EPA and DHA will alter fuel selection at rest and during exercise, and     this will correspond to an increase in the concentration of membrane fatty acid transport     proteins, and that these changes will correlate to an increase in the EPA, DHA, and total     omega-3 content of plasma and mitochondrial membranes.   "
118719|NCT01731990|"     This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg     artery structure and physical activity in patients with atherosclerotic peripheral artery     disease and leg pain from walking.   "
118720|NCT01731977|"     The onset of Psychosis forces family members to bear a heavy burden of care. The mental     well-being of the family is so complicated that it is important to relieve their     psychological stresses. Although family psychoeducation has been established as an     evidence-based practice especially for schizophrenia, few studies have primarily intended to     reduce the distress of the family due to the burden of care. MacFarlane's multifamily     psychoeducation is one of the representative models of a group setting, which is based on the     behavioral therapeutic approach. In such psychological interventions, it has been emphasized     to focus on the strengths that a person originally has for coping with difficulties. The     intervention of mainly drawing the strengths from the family might empower them and lighten     their psychological burden.      The first 2-5 years from the onset of psychosis is regarded as the critical period to improve     the prognosis, so the intervention including more recent-onset psychotic patients might be of     use. With regard to a setting of the psychoeducational intervention, a homogeneous group one     can make the program better fitted for their problems. The present study aims to examine if     the strength-based family psychoeducaiton for youth psychosis in a group setting in addition     to the treatment as usual would be more effective for alleviating the psychological     distresses of the family than the treatment as usual alone. Moreover, its impact on the     family of recent-onset psychosis is explored as the subgroup.   "
118721|NCT01731964|"     This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in     patients with bilateral moderate to profound central vision impairment due to end-stage     age-related macular degeneration.   "
118722|NCT01731951|"     This pilot clinical trial studies how well imetelstat sodium works in treating patients with     primary or secondary myelofibrosis and other myeloid malignancies. Imetelstat sodium may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth   "
118723|NCT01731938|"     This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in     patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be     present. The purpose of this study is to demonstrate that FS Grifols is not inferior to     commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time     to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for     study teams to become familiar with the application of FS Grifols and a Primary Part (II) to     assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be     randomized in a 1:1 ratio to either FS Grifols or Surgicel.   "
118724|NCT01731925|"     Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of     subjects with neuroendocrine tumors.   "
118725|NCT01731912|"     This pilot clinical trial studies how well degarelix acetate before and during radiation     therapy works in treating patients with prostate cancer. Androgens can cause the growth of     prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens     made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink     tumors. Giving degarelix acetate together with radiation therapy may work better in treating     prostate cancer.   "
118726|NCT01731899|"     Depression and unrefreshed sleep are frequent in patients with fibromyalgia. Agomelatine is a     new antidepressant with sleep-promoting properties. The objective of this study include the     assessment of agomelatine therapy in patients with depression and fibromyalgia both on the     severity of depressive symptomatology and sleep quality.   "
118728|NCT01731873|"     The purpose of this research study is to identify factors and genes (the nucleic acid     material that determines the makeup of the human body) that may be associated with how     children respond to pain medication, like morphine, which are called opioids. Though these     pain medicines are used every day, some children have bad reactions from their use, like     breathing problems, sedation, etc. It is not possible to completely predict which pain     medicine is 'right' for a child. The investigators want to study factors that may be     associated with pain sensitivity, pain medicine requirements after surgery, and their     side-effects. The investigators expect that the information obtained in this research study     will help to develop effective, safer, and tailored treatment options in the future.   "
118729|NCT01731860|"     A standard PET/CT scanner is comprised of two different machines: An X-ray computed     tomography scanner (CT), which gives information about your anatomy, and a Positron Emission     Tomography scanner (PET) that provides information about how the body functions. Both of     these work together to make the final images for doctors to review. As part of this research     study the investigators would like to test a new scanner technology by evaluating the quality     of the images obtained using this new PET system.      The scanner the investigators would use is able to do both types of examination, the standard     PET/CT and the additional research PET. The new PET system adds a second scanner ring to the     standard PET/CT. This allows the patient to stay on the same imaging table for both studies.     Being in this study does not change how the standard PET/CT will be done.   "
118730|NCT01731847|"     The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing     rehabilitation in stroke patients with moderate-to-severe dysphagia.   "
118731|NCT01731834|"     There may be pain and / or stress with vibrocompression. There may be pain and / or stress     with the aspiration of secretions.   "
118732|NCT01731821|"     Pancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study     is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named nonstented     stump-closed pancreaticojejunostomy in pancreatoduodenectomy, which could provide a feasible     option to pancreatic surgeons for patients with pancreaticoduodenectomy.   "
118733|NCT01731808|"     The purpose of the study is to evaluate the feasibility and effectiveness of a physician     directed nurse managed earlier outpatient counselling intervention for patients with diabetic     foot ulceration.      For the purpose effectiveness is defined in two ways.1) as a reduction in hospital     readmissions for complication for foot ulcers such as amputation or increased severity of the     ulcer and 2) reduction in amputations, readmission rates. Selected covariates     (self-efficacy,self-management, social support and depression) will be included to estimate     predictors for readmission and amputation.   "
118734|NCT01731795|"     BACKGROUND: Currently, there is no proven pharmacologic treatment for patients with the acute     respiratory distress syndrome (ARDS). Great interest remains in the use of corticosteroids     for the salvage of patients with severe acute lung injury in the early phase of their disease     process, a situation that that has not been evaluated in most published trials. Dexamethasone     has never been evaluated in ARDS in a randomized controlled fashion.      HYPOTHESIS AND OBJECTIVES: The investigators hypothesize that adjunctive treatment with     intravenous dexamethasone of patients with established ARDS might change the pulmonary and     systemic inflammatory response and thereby will increase the number of ventilator-free days     and will decrease the extremely high overall mortality. Our goal is to examine the effects of     dexamethasone on length of duration of mechanical ventilation (assessed by number of     ventilator-free days) and on mortality, in patients admitted into a network of Spanish     intensive care units (ICUs) who still meet ARDS criteria at 24 hours after ARDS onset.   "
118735|NCT01731782|"     Patients experience pain after surgery mostly from their abdominal wounds, even when those     wounds are small. Decreasing that pain has many benefits. It improves comfort, decreases     stress response and might improve the outcome of the surgery. Local anesthesia (which is a     numbing agent given directly at the site of pain via a needle) is given to decrease the pain     that is felt after surgery and decrease the need for strong pain medications which can have     negative side effects.      One promising way to give local pain medication is called the transversus abdominis plane     or TAP block. This method works by directly blocking the nerves in the abdomen that are the     cause of the pain patients feel in their incision after surgery. This is done by injecting a     numbing agent (Bupivacaine) into the area of their abdomen where their nerves are located     that cause pain.      In the case of nerves that carry sensation, bupivacaine blocks the pain sensation traveling     in a particular nerve.      Patients will be randomized (like a flip of a coin) to receive either a normal saline     injection or the bupivacaine injection.      The purpose of this study will be to prove the effectiveness of local anesthetic given via a     TAP block in improving postoperative pain, decreasing the use of pain medications, decreasing     postoperative nausea and vomiting and improve surgical outcomes such as hospital length of     stay in laparoscopic colorectal surgery.   "
118736|NCT01731769|"     Axillary dissection is the standard treatment for breast cancer patients with positive nodes.     However, seroma formation after axillary dissection remains the most common early     complication to breast cancer surgery. It can delay the initiation of adjuvant therapy,     predispose to wound infection, delay wound healing and has also been linked to arm     lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is     effective in complex wound failures following axillary dissection and groin dissection, we     use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed     to evaluate the efficacy, safety and economics benefits of early VAC application on     postoperative complications and wound healing after extensive axillary dissection in     comparison to conventional suction drain.   "
118737|NCT01731756|"     Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized,     double-blind, placebo-control trial   "
118738|NCT01731743|"     The purpose of the study is to evaluate the far, intermediate and near visual acuities with a     trifocal IOL.   "
118739|NCT01731730|"     The objectives of this proof of concept study are to evaluate the safety and preventive     analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in     patients undergoing unilateral total knee arthroplasty.   "
118769|NCT01731327|"     This study will explore the drug behavior and safety following single doses of tofacitinib     modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.   "
118740|NCT01731717|"     The main aim of the project is the implementation and evaluation of a stepped care model     (SCM) for patients with depression with 6 treatment options of varying intensity and setting,     including innovative technologies (e-mental health, telephone-based psychotherapy). Within     this complex intervention, patients are treated by a multiprofessional network of health care     providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a     control group receiving treatment as usual (cluster randomization on the level of     participating general practitioners). It is expected that the SCM condition will show better     results regarding reduction of mental symptoms, improvement of quality of life, more     efficient access to care and better cost-benefit ratio.   "
118741|NCT01731704|"     This is randomized study of neurocognitive outcomes in patients with five or more brain     metastases treated with stereotactic radiosurgery (SRS), specifically the Gamma Knife (GK)     system, or whole-brain radiation therapy (WBRT). The primary aim of this study is to compare     the change in neurocognitive function outcome between baseline and 6 months in WBRT versus     SRS treatment groups.   "
118742|NCT01731691|"     Our primary objective is to further characterize the mechanism by which alpha-1PI regulates     CD4 counts.      HIV-1 infected patients will be initiated on PROLASTIN®-C (Alpha-1 Proteinase Inhibitor     [Human], Grifols Biotherapeutics Inc.) or placebo. Uninfected volunteers will be untreated     and will be monitored for comparison.   "
118743|NCT01731678|"     Major depression (or MDD) in adolescents is a major public health problem. MDD affects     approximately 15% of adolescents; it is associated with impairment in social, family, and     academic functioning, and it is a major risk factor for suicide - a leading cause of death in     adolescents . Unfortunately, there is a paucity of treatment options for this age group.     Selective serotonin reuptake inhibitors (SSRIs) are the only class of medications approved     for treating MDD in adolescents, but rates of remission following treatment with SSRIs are     only 30 to 45 percent. Cognitive behavior therapy is associated with similar remission rates     and access is limited. Most adolescents will require more than one therapeutic intervention     in order to achieve full symptom control. Collectively, there is overwhelming evidence that     additional treatment options are urgently needed to improve outcomes for teens with MDD. One     novel treatment for adolescent MDD is repetitive transcranial magnetic stimulation (rTMS).     Studies in children have been limited (a total of 23 cases). This is surprising given the     evidence suggesting younger adult subjects with MDD respond better to rTMS (56% response     rate) than older subjects. This limited experience with rTMS for adolescent MDD represents a     substantial gap in the knowledge, recently recognized in publications calling for further     study of rTMS in adolescent depression. Most importantly, the mechanism of action of rTMS in     adolescent MDD is not well understood. The objective of this application is to develop an     understanding of the brain alterations associated with the positive clinical changes that     occur with rTMS in adolescent MDD. Such knowledge will provide the basis for pursuing rTMS     for adolescent MDD as a rational therapeutic technique.      Specific Aim: To compare the effect of rTMS on DLPFC glutamate concentration in adolescent     MDD. The investigators hypothesize an increase (normalization to controls) in DLPFC glutamate     after three weeks of rTMS. Furthermore, the change in glutamate concentration will correlate     with a change in MDD symptoms.   "
118744|NCT01731665|"     The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics     and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul,     Korea.   "
118745|NCT01731652|"     This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with     CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.   "
118746|NCT01731639|"     A new technique based on the motile sperm organelle morphology examination (MSOME) at a     magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both     shape and chromatin content, which is the most important sperm organelle in influencing     intracytoplasmic sperm injection (ICSI) outcomes.   "
118747|NCT01731613|"     This clinical trial will compare how the individualized and fortified human milk feeding will     help a premature infant grow.   "
118748|NCT01731600|"     This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and     pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)     in children with severe haemophilia A who have undergone treatment with previous factor VIII     (FVIII) products.   "
118749|NCT01731587|"     Phase Ib study investigating whether liposome BLP25 mucin-1 (MUC1) peptide-specific     immunotherapy (L-BLP25) administered as weekly subcutaneous doses over 8 weeks following a     single dose of intravenous cyclophosphamide (CPA) induces a reproducible cytokine pattern     measured in the serum of unresected Stage III non-small cell lung cancer (NSCLC) subjects     after first-line chemo-radiation therapy.   "
118750|NCT01731574|"     This trial will investigate the potential drug-drug interaction between dapivirine vaginal     Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of     co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy,     HIV-negative women.   "
118751|NCT01731561|"     The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA     and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis:     prospective, multicenter, controlled, randomized comparative study of two rituximab regimens:     one based on ANCA and CD19 lymphocytes versus systematic infusions.   "
118752|NCT01731548|"     We hypothesized that the local control for both arms were not statistically significant, when     irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to     the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted     for both arms.   "
118753|NCT01731535|"     Dose and duration of bisphosphonate therapy will increase the likelihood that patients     experience delayed healing of non-union fractures.   "
118754|NCT01731522|"     The purpose of this study is to examine the influence of two Eating Frequency prescriptions,     meal (energy intake occurring during three meals per day) and grazing (energy intake     occurring every two to three hours per day), on consumption during an ad libitum meal     consumed at the end of the day, overall daily energy intake, and ratio of energy intake to     energy expenditure. It is hypothesized that the grazing condition will produce lower     consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio     of energy intake to energy expenditure than the meal condition.   "
118770|NCT01731314|"     This study investigates the learning and memory of pain.   "
118817|NCT01730703|"     The purpose of this interview study is to learn why adults would join a walking program. This     study involves interviews with persons who are 65 years of age or older. The interview takes     approximately 25 minutes. A total of 132 people will be enrolled. This study will examine the     utility or value of various potential features of an incentive-based walking program. These     data will enable us to monitor and improve upon enrollment of incentive-based walking     programs.   "
118755|NCT01731509|"     Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in     those cases with severe forms where there are extremely reduced lung volumes, liver     herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal     occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal     pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal     pulmonary response followed FETO can be used to predict outcome and is dependent on the size     of the fetal lung prior to the procedure.      We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form     of CDH will have a better fetal pulmonary response and higher chance of surviving.   "
118756|NCT01731496|"     The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and     boys starting at age 11, although it can be offered as young as 9 years of age. This is a     3-dose series and many adolescents do not complete it after getting the first dose. This     study will study how effective it will be to send reminders to parents to schedule an     appointment when their child is due for the next dose of HPV. Parents can chose whether they     would like a phone call or text message reminder. This study will determine if the reminders     work, and if one method is better than another (phone message vs. text message).   "
118757|NCT01731483|"     the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP     activation in invasive staphylococcal and streptococcal infections.   "
118758|NCT01731470|"     Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic     disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that     dramatically affects quality of life.      Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats) have     demonstrated normalization of urinary frequency indicating that LP may be a potent protectant     of the bladder mucosa against inflammation and irritation. Intravesical LP has so far     demonstrated an excellent safety profile and minimal toxicity at concentrations of 2 mg/ml.     Thus, we hypothesize that intravesical instillation of LP may form a molecular film on     bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally     invasive treatment option to alleviating symptoms.   "
118759|NCT01731457|"     The aims of this study are:        1. assessment of ischemia injury of kidney retrieved from standard and expanded criteria          deceased donor before transplantation        2. assessment of efficacy of kidney ischemia injury decreasing        3. assessment of influence of kidney ischemia injury decreasing on its function after          transplantation For the purpose of this research one hundred kidney will be retrieved          from deceased donors (standard and expanded criteria deceased donors) for          transplantation. All kidneys before transplantation will be stored in machine perfusion          in hypothermia with continuous flow - Organ Recovery Systems LifePort - each single          kidney in self-contained perfusion system.      For the kidney allograft assessment will be used measurements performed during machine     perfusion in hypothermia: renal flow, resistance, lactate dehydrogenase, lactates and     ischemia injury markers measured in the fourth hour of perfusion in perfusion fluid.      For kidney ischemia injury assessment such markers will be measured: tumour necrosis factor     (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein     (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1),     neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3.      Every time from pair of retrieved kidneys each kidney will be randomise for one of the group:        -  group 1) - 50 kidneys - examined group - cured with etanercept (ENBREL) in the first          hour of perfusion by adding drug to perfusion fluid,        -  group 2) - 50 kidneys - control group - without intervention. Ischemia injury markers          will be measured in perfusion fluid by kidney two times (in the first and fourth hour of          perfusion) for assessment of efficacy kidney ischemia injury decreasing.      Results of measurements of kidney ischemia injury before transplantation, parameters during     machine perfusion in hypothermia and donor parameters will be correlated with kidney     allograft function post transplantation.      Immediate, delayed and slow graft function, primary non-function, kidney function assessed by     creatinine concentration and creatinine clearance at one day, seven days, two weeks, 1, 6 and     12 months post transplantation and kidney graft survival 6 and 12 months post transplantation     will be analysed.   "
118760|NCT01731444|"     The standard of care for treatment of burn injury is to inject a solution of epinephrine     under the skin of the injured site in order to reduce blood loss during skin grafting. This     solution of epinephrine has been shown to have effects on the body outside the donor site.     Some people have increases in heart rate and blood pressure. We will study the effect of a     phenylephrine solution in place of an epinephrine solution to control blood loss. We think     that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.      The injured area will be injected under the skin and a skin graft will be taken in the same     way as we usually do. The only change will be the use of phenylephrine in the solution     instead of epinephrine.      Our goal is to find whether or not phenylephrine or epinephrine solution results in a     reduction of blood loss without affecting the rest of the body.   "
118761|NCT01731431|"     This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the     treatment of gestational diabetes.   "
118762|NCT01731418|"     The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an     effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD)     and depression and for the improvement of daily functioning in Iranian women who have     experienced intimate partner violence (IPV). In addition, the study seeks to investigate     whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within     their marriage.   "
118763|NCT01731405|"     The purpose of this study is to determine the potential efficacy of three revised Medication     Guide layouts to increase consumers' comprehension   "
118764|NCT01731392|"     To investigate the effect of milk-based formulas on infections and immune functions in     healthy children.   "
118765|NCT01731379|"     Investigation of application possibilities of optical spectroscopy within the field of     surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the     possibility to specifically differentiate between different (human) tissues. The hypothesis     is that incorporation of this technique into existing medical devices (e.g. medical blade)     would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during     surgery can lead to decreased postoperative morbidity rates.   "
118766|NCT01731366|"     Objective: To identify how specific changes of the whole grain content in the diet affect the     host-gut microbiome interactions with implications for metabolic health .      Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of     two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60     participants will be included.      Intervention: low vs. high whole grain intake.   "
118767|NCT01731353|"     The objective of this registry is to broaden the knowledge on epidemiology, diagnostic     procedures and clinical course of emerging invasive fungal infections.   "
118768|NCT01731340|"     The overarching aim of this randomized clinical trial is to estimate the effect of dietary     intake of calcium as compared to supplemental calcium on the vascular system and markers of     vascular and bone health in postmenopausal women.   "
118771|NCT01731301|"     1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD          undergoing hemodialysis.        2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease          (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with          peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.        3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis          can achieve rapid virologic response (RVR), extended virologic response (eRVR) and          sustained virologic response (SVR) when treated with peginterferon alfa-2b, the          maximally tolerated dose of ribavirin and boceprevir.   "
118772|NCT01731288|"     The main purpose of this study is to assess conception, pregnancy, childbirth, and pain     experiences among women who have been diagnosed with vulvodynia. Specifically, this study     aims to examine the following among women who have been diagnosed with vulvodynia: 1) rates     of pregnancy/childbirth and desire for children; 2) fear of pregnancy and childbirth; 3)     potential difficulties experienced while attempting to become pregnant and during     pregnancy/childbirth; 4) methods used to become pregnant and deliver; 5) methods used to     manage vulvodynia symptoms during pregnancy; and 6) pain outcomes associated with pregnancy.      Very little research has examined pregnancy/childbirth experiences among women with     vulvodynia, or the natural history of vulvodynia. As such this is a preliminary investigation     that will provide descriptive information regarding many of the proposed research questions.     Based on the clinical experience of the investigators, it is expected that women with     vulvodynia will report lower rates of pregnancy and higher levels of fear about pregnancy and     childbirth in comparison to women without such pain. It is also expected that women with     vulvodynia will report more difficulties becoming pregnant as compared to women without such     pain, and that women with vulvodynia will report more elective nonvaginal births in     comparison to vaginal births.   "
118773|NCT01731275|"     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single     ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.   "
118774|NCT01731262|"     Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not     been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial     angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was     to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of     fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.   "
118775|NCT01731249|"     The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of     300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior     to the birch pollen season and continuing over the birch pollen season compared with placebo     for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.   "
118776|NCT01731236|"     The principal goal for the study is to examine the role gut flora plays in modulating     metabolism of dietary carnitine and choline in humans.   "
118777|NCT01731223|"     The aim of this study is to analyze if group treatment is effective to treat insomnia in     primary healthcare.   "
118778|NCT01731210|"     The LENEA study is an international, prospective, open label, non-randomized multicenter     clinical research study designed to assess the safety and effectiveness of the NANO LV lead     system.   "
118779|NCT01731197|"     Proteins are known to be more satiating than the other macronutrients; however, the type and     amount of protein needed to induce a significant effect on satiety (fullness between meals)     is sometimes difficult to determine. In this study, 2 differentially processed isolated soy     proteins will be tested for satiety using subjective visual analogue scales. The amount of     food consumed following intake of the isolated soy proteins will be measured 3 hours after     consuming the proteins. The hypothesis is that differentially processed isolated soy proteins     will show unique satiety responses.   "
118780|NCT01731184|"     Administration of midazolam with morphine in patients with severe acute pain is a routine     practice in the management of pre- and post-operative patients but has not been evaluated in     pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam     in the pre-hospital management of traumatic patients with severe acute pain.      In a multicenter prospective randomized double-blind placebo-controlled trial, the     investigators would like to compare the analgesic effect and safety of the intravenous     morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and     placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a     validated numeric rating scale (NRS).      The primary outcome will be the proportion of patients with a pain score less than or equal     to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the     treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose     required until obtaining a pain score less than or equal to 3.   "
118781|NCT01731171|"     The purpose of this study is to determine if taking a probiotic supplement versus a placebo     will lower rates of relapse and improve the clinical course among participants who have been     hospitalized for mania. Relapse and clinical course are measured by time to     re-hospitalizations, new mood episodes, and changes in mood-related symptoms.   "
118782|NCT01731158|"     This will be a prospective, open label, randomized multicenter phase-II study to evaluate     progression free survival (PFS) in 2nd line treatment in patients with locally advanced or     metastatic clear-cell renal cell cancer (cc-RCC) receiving everolimus (arm A) in comparison     to a tyrosine-kinase inhibitor (TKI) (arm B). Following 2nd line treatment, patients will be     switched to a TKI in arm A and everolimus in arm B. All patients will receive bevacizumab as     standardized first-line treatment.      Another key element of the study is the analysis of predictive biomarkers, which will be     performed in serum and tumor tissue, respectively. Serum samples will be collected at     prespecified timepoints throughout the study and analysed by SELDI-TOF-MS and DIGE. Candidate     proteins are thought to predict therapeutic outcome and candidates are subject for target     validation by Western Blot or ELISA. In addition, formalin-fixed paraffin-embedded (FFPE)     tumor tissue will be collected prospectively and analysed for micro RNA (miRNA). Candidate     miRNAs that predict therapeutic outcome will be validated by quantitative RT-PCR.     Furthermore, circulating tumor cells (CTCs) will be generated from blood drawings during     routine visits. The primary objective is to correlate the marker profile defined from the     FFPE tissue with the profile obtained from CTCs in order to validate expression based markers     ant their change during different treatment lines.   "
118785|NCT01731119|"     The overarching purpose of this pilot study is to collect preliminary data regarding the     variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic     naive children and adolescents in order to inform decisions about including a lurasidone arm     in a future large scale trial of different approaches to minimize antipsychotic associated     weight gain in the pediatric population. In adults, lurasidone appears to cause minimal     weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum,     or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic     exposure.   "
118786|NCT01731106|"     Brief Summary Cerebral Autoregulation is a well known physiological response to blood     pressure changes to maintain the cerebral perfusion. The critically ill patients are     submitted to different situations that can impair the cerebral autoregulation as sepsis,     sedation drugs and mechanical ventilation.      The delirium on ICU has been described as a bad prognosis factor, increasing the mortality     and length of stay. The physiopathology of delirium has been related to cerebral perfusion.     The delirium has been related to long term cognitive impairment.      Material and Methods:      This is a physiological prospective study that will be done in a 14 bed medical-surgical ICU.     The investigators will enroll 100 ventilated patients, septic and non-septic. The     investigators will measure cerebral autoregulation every 48-72 hours from admission on ICU.     Neurological biomarkers (Neurological Specific Enolase, S100 beta and Vascular Endothelial     Growing Factor) will be done at inclusion, 72 hours and 7 days. Clinical data, delirium     presence, analytic data and ventilatory parameters will be registered every day.      At hospital discharge, a psychologist will do a cognitive evaluation using specific tests.     The cognitive evaluation will be repeated at 3, 6 and 12 months.      Anticipate results:      Some items like mechanical ventilation, sepsis and sedation can impair cerebral     autoregulation. The impairment of cerebral autoregulation is related to delirium in ICU and     long cognitive impairment.   "
118787|NCT01731093|"     The purpose of this study is to determine the safety, bioavailability, and effectiveness of     an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in     the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium     is a very powerful antioxidant that could prove useful in reducing the harmful effects of     oxidative stress in the brain and may help prevent diseases such as Alzheimer's. Our recent     work has demonstrated that the specific type of selenium compound greatly influences it's     ability to enhance brain health and prevent Alzheimer changes in mouse models of this     disease.      This study will enroll 24 participants and will allow us to test the hypotheses that     yeast-selenium supplementation is safe in the elderly, and that our specific formulation     reduces brain oxidative stress.   "
118788|NCT01731080|"     Quantification and preferential sites of arterial wall calcification within the coronary and     lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2     diabetics and Chronic Kidney disease.   "
118789|NCT01731067|"     Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and     transporters in vivo. It consists of the administration of probe substances metabolised by a     specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the     determination of a metabolic ratio or the evaluation of the plasmatic or urinary     concentrations of the probe substances. The administration of a cocktail containing several     probe substances allows the simultaneous evaluation of the activity of several cytochromes     and P-gp in a single test.      The aim of this project is the validation of a phenotyping cocktail of low dose probe drugs     for the assessment of cytochrome P450 and P-gp activities by simple capillary blood sampling     and dried blood spot (DBS) analysis. The cocktail consists of caffeine, bupropion,     flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous     phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.      The modulation of the activity of cytochromes or P-gp will be evaluated by the administration     of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin) of the metabolic     pathways or the P-gp mediated transport.   "
118790|NCT01731054|"     The primary objectives of the study are as follows: To develop and optimize a renal     functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted     Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial     Spin Labeling MRI (ASL-MRI), Phase Contrast MRI (PC-MRI), and T1rho-MRI; To compare renal     functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and lupus     nephritis (LN) participants.      The secondary objectives of this study are as follows: Explore whether renal functional MRI     techniques discriminate between renal inflammatory activity and damage in lupus nephritis     (LN); To examine whether renal functional MRI measurements correlate with laboratory features     of renal involvement and renal function in participants with lupus nephritis (LN).   "
118791|NCT01731041|"     Platelets are parts of your blood that stick together to help form a clot. The stickier your     platelets are, the greater your chance of having a heart attack. A clot in the wrong place     can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking     together and it helps people from having a heart attack. The American College of Cardiology     has recommended a combination of aspirin and Brilinta as one of the best treatments for the     prevention of heart attacks, and death in patients who have had a heart attack or coronary     stents. However, it is unknown if Brilinta may improve its work to keep platelets from     sticking together giving a loading dose in patients already treated with Brilinta. A loading     dose is a one-time increased dose of the same drug. The purpose of this study is to     demonstrate whether the platelets of patients treated with Brilinta become less sticky when     Brilinta is re-loaded.   "
118792|NCT01731028|"     The purpose of this study is to investigate the long-term treatment with Zomacton® for     pituitary short stature in children with insufficient growth hormone production and/or short     stature caused by Turner's syndrome.   "
118793|NCT01731015|"     The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as     an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to     allow an effect size estimate to power future studies.   "
118794|NCT01731002|"     Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison     of Netarsudil (AR-13324) to latanoprost   "
124697|NCT01653496|"     The purpose of this study is to prospectively evaluate the overall compliance to the enhanced     recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.   "
118795|NCT01730989|"     Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night     sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality     of life. The gradual decline of oestrogen from peri-menopause results in altered function of     many neurotransmitters, such as dopamine, melatonin and neuropeptides including     beta-endorphins, which modulate the function of the hypothalamus and are involved in body     thermoregulation.      In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2     receptors is effective in relieving hot flushes and in reducing the accompanying     psychological symptoms.      The use of hormone replacement therapy, which is generally prescribed in the case of moderate     or severe symptoms, is limited due to real contraindications or simply the woman's refusal to     take the therapy, despite the presence of symptoms requiring its use.      A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones,     the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin     D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing     vasomotor symptoms.      To potentiate the effect of E on the most frequent symptoms in menopause, it was considered     rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste     tree, acting on both hot flushes and psychological symptoms and a new food supplement was     developed: Estromineral Serena Plus (ESP).      Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste     tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.   "
118796|NCT01730976|"     We will study whether taking vitamin D improves asthma control and spirometric values in     elderly asthmatics.   "
118797|NCT01730963|"     This multi-reader multi-case study was designed to evaluate the performance of SureCALL®     Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).   "
118798|NCT01730950|"     This randomized phase II trial studies how well bevacizumab with or without radiation therapy     works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry cancer-killing     substances to them. Specialized radiation therapy that delivers a high dose of radiation     directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is     not yet know whether bevacizumab is more effective with or without radiation therapy in     treating patients with recurrent glioblastoma   "
118799|NCT01730937|"     This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation     therapy to see how well they work compared to sorafenib tosylate alone in treating patients     with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send     the radiation dose directly to the tumor and cause less damage to normal tissue. Giving     sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor     cells.   "
118800|NCT01730924|"     The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is     catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation     catheter to deliver targeted burns on the inner surface of the heart. The aim of this     approach is to cause electrical isolation of the pulmonary veins. The purpose of this study     is to evaluate whether the information which can be derived from the latest catheter     technologies - on the degree of contact force between the catheter and the heart - affects     the time to perform the procedure, or the outcomes as a result of it. Patients undergoing     pulmonary vein isolation will be randomised to having their procedure performed with the     contact force information available to the operator, or not available. The time taken to     achieve pulmonary vein isolation is the primary end-point of the study.   "
118801|NCT01730911|"     Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of     women in the US report using them. Women must often wait for their menses to start, or for     results of screening for sexually transmitted infections (STIs), before their doctors will     place IUDs for them. This is not the case with other birth control methods. Researchers know     that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on     the same day of a doctor's visit. In the investigators clinical practice, the investigators     often place IUDs on the same day of a woman's visit, but outcomes have not been formally     assessed.      Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and     the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if     women who have IUDs placed at any time during their menstrual cycle have different     experiences regarding the following, compared to those who have IUDS placed during the first     7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming     pregnant more often during that first cycle (window pregnancy).      Women who come to their provider seeking an IUD for birth control will be asked to     participate in this study. The investigators will ask them to keep track of their bleeding     and cramping for three subsequent months to see if patterns differ according to the day in     their menstrual cycle that the device was inserted. They will be randomly assigned either to     record this information on paper, or to send in the information by responding to daily text     messages.      The investigators want to know if women who have an IUD placed at any time during the     menstrual cycle have different outcomes compared to those who have IUDs placed during the     first 7 days of their cycle. If the investigators have this information, the investigators     can make recommendations to physicians, help counsel patients, and potentially expand access     to IUDs.   "
118802|NCT01730898|"     This study will evaluate the absorption of lutein when consumed in different oil blends.   "
118803|NCT01730885|"     Due to continuing technological progress and better understanding of the needs for glucose     monitoring, the performance requirements of blood glucose meters, primarily regarding their     accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion     was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters     in the point-of-care testing setting by asking for fulfilment of higher requirements.   "
118804|NCT01730872|"     The purpose of this study is to evaluate the effectiveness of the modified Conjunctival     Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to     treatment with a proven ocular anti-inflammatory medication,      Prednisolone, assessed by the following measures:      Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival     redness   "
118805|NCT01730859|"     Both taping and balance exercises have effects on dynamic balance, so this study compared     ankle taping and balance exercise on postural stability indices in healthy women. we     hypothesized that both balance exercise and taping would increase stability indices but the     effects of balance exercise was more greater than taping.   "
118806|NCT01730846|"     The purpose of this study is to examine whether doxazosin will attenuate the ability of     stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants     will participate in a smoking cessation attempt after the laboratory sessions.   "
118807|NCT01730833|"     This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel     albumin-stabilized nanoparticle formulation work in treating patients with human epidermal     growth factor receptor (HER) 2-positive stage II-IV breast cancer. Monoclonal antibodies,     such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel     albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or     stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel     albumin-stabilized nanoparticle formulation may be a better way to block tumor growth.   "
118808|NCT01730820|"     The perioperative hemodynamic management aims to ensure organ perfusion pressure and an     oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic     agonist widely used during anesthesia for arterial pressure control.      Several questions on phenylephrine global and regional hemodynamics effects remain     unresolved.      The investigators assume that Phenylephrine may decrease cardiac output by increasing the     afterload, while most likely could also make an increase or a stability of cardiac output by     action on the venous return. The investigators propose an observational study assessing the     influence of preload dependence, defined by the values of pulse pressure variation, on the     effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.      The aim of the investigators work is to improve the understanding of phenylephrine action, a     daily use therapeutic action, to improve the patients care.   "
118809|NCT01730807|"     A study to assess the performance of a new catheter design for the treatment of Atrial     Flutter.   "
118810|NCT01730794|"     The purpose of this study is to compare a specific mode of artificial ventilation (help from     a breathing machine) with other modes. This specific mode is called Neurally Adjusted     Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from     the diaphragm (breathing muscle) to help patients breathe. The investigators believe that     using these signals, NAVA can determine the exact timing for patients' spontaneous breathing     effort and delivers the artificial breath at the same time (in synchrony) with their own     breath. Other modes (breathing methods) may cause asynchrony between the patient and the     ventilator while delivering artificial breaths because of the way they operate. Asyncrony     between patient and ventilator is a risk factor for increasing the length of artificial     ventilation and number of related complications. The investigators would like to find out if     NAVA performs better in establishing synchrony between patient and ventilator and as a result     decreasing time for artificial ventilation and increasing better outcomes.   "
118811|NCT01730781|"     The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in     the human brain. CB1R are present in everyone's brain, regardless of whether or not someone     has used cannabis. The investigators will image brain cannabinoid receptors using Positron     Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and     several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome     of psychotic illness and 4) individuals with a family history of alcoholism, using the PET     imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and     distribution of CB1R in these conditions. It is likely that the list of conditions will be     expanded after the collection of pilot data and as new data on cannabinoids receptor function     and psychiatric disorders becomes available.      Those in the cannabis us disorder arm of the study will have a PET scan on at least three     occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and     a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4     weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most     schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more     than once. For example to tease out the effects of medications, unmedicated patients may get     scanned while unmedicated and again after treatment with antipsychotic medications. Similarly     prodromes may get scanned while in the prodromal stage off medications, on medications and     after conversion to schizophrenia.   "
118812|NCT01730768|"     This is a study in chronic stable Schizophrenia with the purpose to answer the question of     whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well     defined chronic stable patient population treated with antipsychotics as standard of care,     and thus to support the future development of AQW051 for the treatment of cognitive     impairment associated with Schizophrenia (CIAS).   "
118813|NCT01730755|"     Chuvash polycythemia (CP) is a rare form of congenital polycythemia caused by mutations in     the VHL gene. Currently, there are no therapies that have proven effective for CP. Recent     studies have demonstrated that VHL (von Hippel-Lindau tumor suppressor) regulates the     activity of JAK2 (Janus kinase 2). In mouse models, inhibition of JAK2 reverses the CP     phenotype. Therefore, the investigators hypothesize that JAK2 inhibition may have significant     clinical benefits for CP patients.   "
118814|NCT01730742|"     The study proposes to investigate whether sleep deprivation will affect a variety of     measures, including hormones, immune system functioning, and behaviors related to food intake     and hunger. It is predicted that sleep deprivation will affect circulating neutrophil     activity, and do so via affects on DNA methylation. It is also predicted that sleep     deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. Finally, it is     predicted that sleep deprivation will increase participants' tendencies to pick larger     portions of food, and also increase their tendency to purchase foods that are more caloric in     a mock supermarket scenario.   "
118815|NCT01730729|"     Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that     elevated levels of the hormone prolactin might be associated with an increased risk of breast     cancer. Cabergoline has been shown to lower prolactin levels in the blood.      The purpose of this study is to evaluate the effectiveness of cabergoline in treating     metastatic breast cancer disease in those who test positive for the prolactin receptor.   "
118816|NCT01730716|"     The study is to determine the feasibility, safety, toxicity, and maximum tolerated (safe)     dose of human spinal derived neural stem cell transplantation for the treatment of     Amyotrophic Lateral Sclerosis (ALS).   "
118840|NCT01730404|"     Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics     (effect on biological markers of inflammation in induced sputum and in blood, and on     pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of     daily inhaled dosing.   "
118818|NCT01730690|"     Major changes in the epidemiological characteristics of bacterial meningitis have been     observed as a result of changes in behaviour, human interventions (use of antibiotics,     prophylactic vaccinations), as well as poorly elucidated mechanisms responsible for epidemic     outbreaks.      The objective of this study is to identify the determinants of in-hospital mortality of     bacterial meningitis in adults.      Hypothesis : the standardized data collection concerning cases of bacterial meningitis in     adults with telephone follow-up would allow analysis of the determinants of mortality and     neurosensory sequelae, description of the psychosocial impact and proposal of new treatment     strategies.   "
118819|NCT01730677|"     The investigators address the clinical efficacy of continuing lapatinib treatment combined     with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared     with vinorelbine alone in HER2 positive metastatic breast cancer patients.   "
118820|NCT01730664|"     Rationale:      Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real     challenge as failure in response to treatment and serious side-effects are frequently     encountered. New, more effective drugs with less side effects are therefore urgently needed     to solve this problem. Although several new drugs against TB are in the pipeline, physicians     currently have limited treatment options for treatment of complicated MDR/XDR-TB cases.     Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB.      Objective:      The main objective of this prospective clinical trial is to evaluate pharmacokinetics of a     standard dose (2000mg) of ertapenem in TB patients. This clinical trial will provide     important information on PK of ertapenem in TB patients for future studies. Data can be used     for limited sampling strategies for ertapenem based on a pharmacokinetic population model     constructed from the full PK curves of the patients.      Study design:      A prospective pharmacokinetic study.      Study population: 12 TB patients.      Intervention: Single dose of 2000mg in a 30 minutes intravenous infusion.      Main study parameters/endpoints:      The pharmacokinetic parameters (Vd, Cl, AUC, etc) of ertapenem are the primary endpoints of     the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most     likely the best predictive parameters for efficacy of ertapenem treatment and will be     calculated for a range of M tuberculosis isolates.   "
118821|NCT01730651|"     This phase II study of high dose intensity modulated radiation therapy in the cervical cancer     with metastatic lymphadenopathies at initial diagnosis   "
118822|NCT01730638|"     The aim of this study is to optimize pretargeting parameters using pharmacokinetic and     imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288     peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at     least one abnormal lesion   "
118823|NCT01730625|"     The development of easily disseminated and efficacious treatment of psychiatric disorder is     an important goal for translational neuroscience research. To that end, Attention Bias     Modification Treatment (ABMT), a novel intervention targeting threat-related attention     biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined     whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has     examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the     treatment of choice for anxiety disorders. Studying this question in youth is particularly     important given that the onset of most anxiety disorders is during childhood, and early     interventions may reduce long-term affliction. The current study is the first randomized     control trial designed to examine the augmenting effects of ABMT on CBT among clinically     anxious youth.      The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape     anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic     tool. During training, the target location is systematically manipulated to increase the     proportion of targets appearing at the location opposite the patient's bias. For example, in     a training protocol intended to reduce threat bias, targets would appear more frequently at     locations of neutral than threat stimuli.      Although CBT is an effective treatment for anxiety disorders, combining it with other     treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two     interventions targeting different aspects of anxiety and therefore could potentially     complement one another. While CBT modifies explicit and voluntary attention through verbal     intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT,     the integration of the two treatments can have few significant benefits: First, it will     combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce     the number of patients who respond poorly to CBT or do not respond at all. Second,     computer-based training of attention may be more acceptable than traditional in-person     therapy formats for some children and adolescents and can raise the cooperation in therapy.     Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered     consistently      The current study was designed to examine the ABMT augmentation effects on CBT for children     with anxiety disorders. This study is the first randomized control trial in clinically     anxious youth. Participants were randomly assigned to one of three conditions: 1. Training     condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT     alone). We hypothesize that participants in the training condition will show the greatest     improvement in anxiety symptoms.   "
118824|NCT01730612|"     Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68     Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast     carcinoma.      Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to     standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the     development of immunization against TF2 or complex TF2-IMP-288;   "
118825|NCT01730599|"     This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic     mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat     kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between     genetic mutations in the known genes and their influence on disease manifestation over few     years of follow up   "
118826|NCT01730586|"     The goal of this clinical research study is to learn if abraxane can help to control     colorectal and/or small bowel cancer. The safety of this drug will also be studied.      Abraxane is designed to block cancer cells from dividing, which may cause them to die.   "
118827|NCT01730573|"     Primary objective of this study is to prospectively compare and evaluate efficacy as well as     note side effects of the interscalene block and combined suprascapular and axillary nerve     block for ambulatory arthroscopic rotator cuff repair.   "
118841|NCT01730391|"     This study aims to provide an estimate of the proportion of suspected cases of bacterial     meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines     and Vietnam.   "
118842|NCT01730378|"     This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean     subjects. A second group of subjects will receive FluarixTM vaccine as control.   "
118843|NCT01730365|"     Investigation of application possibilities of optical spectroscopy within the field of     oncology. Optical spectroscopy enables the possibility to specifically differentiate between     different (human) tissues. The hypothesis is that incorporation of this technique into     existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of     these devices. The purpose is to improve and speed up the diagnostics and therapy of the     malignancies.   "
118828|NCT01730560|"     Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause     problems with reading and visual exploration which impact on patients' quality of life. Apart     from the substitutive method that uses prisms directly placed on glasses, two main     rehabilitative methods have been explored previously: one restorative and one compensatory.     The most effective methods seem to be based on compensatory training paradigms that target     eye movements. They rely on voluntary mass-practice that induces changes in exploratory     saccadic behaviour, particularly into the blind hemifield. Previous studies using this method     have shown changes in visual scanning patterns but with only a marginal profit in terms of     functional benefit.      In the present study, the investigators developed a new approach to the compensatory visual     field training based solely on a bottom-up mechanism. It does not require the patients'     ability to voluntarily maintain attention oriented to the affected field, which may be     difficult for brain-damaged patients. As previously reported in other pathological contexts     (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing     voluntary and conscious implication of the patient can produce improvements by a more     automatic process.      The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by     hemianopic patients to automatically improve targeted eye movements into their blind visual     field; and 2) that this will lead to behavioural improvements on ecologically valid tests of     visual search.   "
118829|NCT01730547|"     The aim of the study is to evaluate the safety and efficacy of autologous mesenchymal stromal     cells as treatment for Multiple Sclerosis.   "
118830|NCT01730534|"     This study is being carried out to determine the effect of dapagliflozin on cardiovacular     outcomes when added to current background therapy in patients with type 2 diabetes with     either established cardiovacular disease or cardiovascular risk factors.   "
118831|NCT01730521|"     Iron metabolism may undergo changes during exercise, with reductions in classical iron status     markers due to a variety of postulated mechanism which include hemodilution, increased iron     loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that     vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This     increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin     levels may reduce iron bioavailability and iron incorporation in erythrocytes.      Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be     generally healthy, with no history of blood donation in the last 6 months, should weigh less     than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should     have familiarity to sports and running, but not currently (i.e. in the past 3 months)     training for more than 1h per week on average.      The aim of this study is to measure an iron bioavailability during a resting and an exercise     phase lasting approx. 14 days with training sessions on alternate days. Subjects will     participate in both restign and exercising protocols and act as their own controls during the     study. Iron bioavailability will be measured via the incorporation of stable isotopic labels     14 days after administration. To control for changes in blood volume during the course of the     study, blood volume of the participating subjects will be measured before and after the     exercise phase with the CO-rebreathing method.      Measurement of iron bioavailability and iron incorporation in a resting and exercising phase     will allow determine if the increased level of hepcidin seen in in exercise will induce a     lower iron bioavailability and iron incorporation during exercise.   "
118832|NCT01730508|"     This multicenter, prospective, observational study will evaluate the use in clinical practice     and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with     HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local     label will be followed for the duration of their treatment and for one year after cessation     of treatment.   "
118833|NCT01730495|"     The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic     encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell     depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis     factor-alpha inhibition using Etanercept as weekly subcutaneous injections.   "
118834|NCT01730482|"     This study is designed to describe the metabolism of AT1001 (migalastat HCl) and the     contribution of metabolism and urinary excretion to its overall elimination as part of the     continuing assessment of the safety and effectiveness of the drug.      This is a Phase 1, single-site, open-label, single dose study of the absorption, metabolism     and excretion of radiolabeled AT1001 in healthy male subjects between 30 and 55 years of age,     inclusive. Six subjects will be dosed, with the goal of having at least 4 subjects complete     the study through follow-up. All subjects will be screened within 28 days before admission to     the Clinical Unit. Subjects will be confined to the clinical unit for 10 days after dosing     and will return to the clinic for a follow-up visit 28 days after dosing.      Each subject will receive a single oral dose of AT1001 as an aqueous solution containing 150     mg [14C] AT1001 (1 μCi). Blood, duodenal bile, expired air, urine, and feces samples will be     collected at specified time points after dosing throughout the period of confinement at the     study site. Safety will be assessed throughout the study by monitoring clinical laboratory     tests, ECGs, physical examinations, vital signs, and adverse events. The total duration of     the study for each subject is approximately 8 weeks.   "
118835|NCT01730469|"     This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single     dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects     with normal renal function and to subjects with mild, moderate, and severe renal impairment.   "
118836|NCT01730456|"     This multicenter, open-label, single arm, long-term extension study will evaluate the safety     and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe     rheumatoid arthritis who completed the WA19926 core study. Patients will receive     RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.   "
118837|NCT01730443|"     Blood samples will be drawn on traumatic brain injury patients who are participating in the     ProTECT III study.   "
118838|NCT01730430|"     To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing     patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects.     The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity     and 60% specificity.   "
118839|NCT01730417|"     The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane     I 123 in normal human volunteers.   "
118846|NCT01730326|"     Patients with acute migraine attack make up the majority of patients consulting the emergency     services due to headache. The aim of treatment in the emergency service is to achieve a     minimum level of undesirable side effects and to quickly relieve the pain which will not     repeat after discharge from the emergency service. Ideal drug treatment contraindication     should be at a minimum level and not trigger migraine. Paracetamol and Nonsteroidal     anti-inflammatory drugs are often used in the treatment of migraine headache.      Although narcotic analgesics provide effective and rapid analgesia, they have such side     effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the production     of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic efficacy of     these drugs has been one of the topics of interest to researchers. Especially intravenous     form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory drugs, and it     is a drug with a wide safety margin and less incidence of side effects. The effectiveness of     the Intravenous form of paracetamol and whether it can be an alternative to other analgesics     is one of the major research topics today, and more study is needed on this subject.      Both drugs are often used in emergency services to treat headache caused by acute migraine     attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with paracetamol     in the treatment of the headache caused by acute migraine attack.   "
118847|NCT01730313|"     Nodding Syndrome (NS) is a novel form of epilepsy seen predominantly among children aged 5-15     years and characterized by head nodding, progressively worsening seizures, and cognitive     impairment. To date, the cause of NS remains unclear. A recent assessment by the Uganda     Ministry of Health (MOH), World Health Organization (WHO), and US CDC conducted in Kitgum     District in northern Uganda documented that the nodding episodes themselves resulted from     atonic seizures, and that the children also exhibit multiple different seizure types, both     clinically and electrographically. The investigation also found that there was significantly     greater sero-positivity for onchocerciasis among children with NS compared with control     children, and demonstrated low serum concentrations of vitamin B6 (pyridoxine) among both     cases and controls. Vitamin B6 is involved in neurotransmission and has been an effective     treatment of seizures for certain rare type of epileptic syndrome. Children with nodding     syndrome in Kitgum have been episodically treated with multivitamins, ivermectin, and     anti-epileptic medications including phenobarbital, phenytoin, carbamazepine, and valproate,     but the possible beneficial or harmful effects of any of these medications for nodding     syndrome has not been systematically assessed, and reports from parents and guardians about     apparent effectiveness are varied.      The investigators propose a randomized blinded four group clinical trial with crossover     design to study the effect and response to therapeutic doses of oral pyridoxine (vitamin B6)     and treatment with currently used conventional anti-epileptics including phenytoin and sodium     valproate, among children with nodding syndrome.   "
118848|NCT01730300|"     The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing     Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine     bleeding. The patients were asked urogenital distress inventory (UDI) (which includes;     irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact     questionnaire (IIQ) (which includes; physical activity, travel, social/relationships,     emotional health)questionnaires in the day of application LNR-IUD and six months later this     procedure. Statistical analyse will be performed to evaluate the changes in this time period.   "
118849|NCT01730287|"     Deep carious lesions will encounter the dentist with the challenge of selecting a treatment     method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional     restorative treatments suggest complete removal of the caries in one visit which could cause     pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root     Canal Therapy (RCT).      Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the     possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp     Capping (IPC), in this technique only the central infected part of the caries is removed in     first visit and the rest of the caries will be lined by a suitable material to suppress the     remained cariogenic biomass and seal the cavity. This will help the pulp to defend and     survive. After a period, the cavity is re-opened and the rest of the caries which is darker,     harder and with less bacteria will be removed and the tooth is restored permanently.The aim     of this study was to compare the effect of different lining materials in clinical and     radiographical symptoms in stepwise excavation without re-enter after one year.   "
118850|NCT01730274|"     Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional     connectivity level in higher order cognition networks known to interact with the cerebellum.     Furthermore, to correlate the connectivity level of these networks with the     neuropsychological performance and functional outcome of the patients.      The investigator's hypothesis is that the functional connectivity of various cognition     networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging     can be impaired after cerebellar tumor surgery and can be correlated with the     neuropsychological performance. The effect of surgery on the cognition networks and the     neuropsychological performance is dependent on the tumor location within the cerebellum. Such     a correlation seems feasible as functional connectivity analysis could be correlated with the     neuropsychological impairment in various neuropsychiatric disorders. Furthermore,     investigators were able to depict the maturation of the functional connectivity networks in     parallel to the neurocognitive development in childhood   "
118851|NCT01730261|"     This study will examine the feasibility of online delivery of emotional regulation training     to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional     dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions     twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will     be tracked, and outcomes will be monitored using online data collection methods. Treatment     satisfaction and participant subjective experience will also be assessed.   "
118917|NCT01729403|"     This single-center, randomized, double-blind, placebo-controlled study will evaluate the     effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who     are inadequately controlled on metformin monotherapy. Patients will be randomized to receive     either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their     existing dose and regimen of metformin.   "
119109|NCT01726868|"     The aim of this study is to evaluate efficacy and safety of blood purification therapy on     renal dysfunction by cholesterol crystal embolism.   "
118852|NCT01730248|"     The purpose of this phase Ib clinical trial is to evaluate the safety of the combination of     INC424 and BKM120 in the myelofibrosis population and to establish the maximum tolerated dose     and or the Recommended Phase II dose of the combination guided by the Bayesian dose     escalation model. INC424 has shown efficacy in myelofibrosis (MF) and is approved in the US     and EU for the treatment of MF. BKM120 is a PI3K inhibitor. Preclinical and early clinical     experience support inhibition of the PI3K/mTOR pathway in MF as aberrant activation of the     pathway has been observed in MF models and may contribute to the pathogenesis of the disease.   "
118853|NCT01730235|"     The last mile of the medication use system requires tools to help patients comply with     medication administration rules and monitor for side effects. Personal health records (PHR)     and emerging user-adopted communication tools promise to change the landscape of medication     management. The overarching goal of the MyMediHealth project is to investigate ways in which     PHRs and supported applications can improve the safety and quality of medication delivery.     Preliminary work in this area by a team of parents, patients and school/clinic health     providers created a vision for MyMediHealth, a next-generation medication management system.     MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure     safe and effective medication delivery. This vision featured just-in-time medication     reminders to children with special health care needs, two-way communication to log when doses     have been administered or when side effects have occurred, and mechanisms to warn caregivers     about side effects and drug interactions. However, much of this work was done using     prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried     out without significant changes in processes and policies, the purpose of this proposed study     is to evaluate the impact of medication management tools such as MyMediHealth on medication     adherence for children with chronic illnesses. Specifically, the investigators hypothesize     that compared with usual practice, children using mymedihealth will have improved medication     adherence and will report improved (decreased) asthma symptoms.   "
118855|NCT01730209|"     Tuberous sclerosis complex (TSC) is a genetic disease that leads to mental retardation in     over 50% of patients, and to learning problems, behavioral problems, autism and epilepsy in     up to 90% of patients. The underlying deficit of TSC, loss of inhibition of the mammalian     target of rapamycin (mTOR) protein due to dysfunction of the tuberin/hamartin protein     complex, can be rescued by everolimus. Everolimus has been registered as treatment for renal     cell carcinoma and giant cell astrocytoma (SEGA). Evidence in human and animal studies     suggests that mTOR inhibitors improve learning and development in patients with TSC.   "
118856|NCT01730196|"     Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of     the GLB program compared with a health education intervention.   "
118857|NCT01730183|"     This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate     the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal     cord injury patients.   "
118858|NCT01730170|"     Epilepsy is one of the most common neurological disorders affecting women of childbearing     age. Poor pregnancy outcomes are increased in these women and their children. The proposed     studies will increase our knowledge on multiple levels to improve care and reduce adverse     outcomes in these mothers and children. An overall goal of this study is to establish the     relationship between antiepileptic drug exposure and outcomes in the mother and child as well     as describe and explain the variability in antiepileptic drug exposure and response.   "
118859|NCT01730157|"     This pilot clinical trial studies radioembolization and ipilimumab in treating patients with     uveal melanoma with liver metastases. Radioembolization kills tumor cells by blocking the     blood flow to the tumor and keeping radioactive substances near the tumor. Monoclonal     antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or     carry tumor-killing substances to them. Giving radioembolization together with ipilimumab may     kill more tumor cells in patients with uveal melanoma   "
118860|NCT01730144|"     Background:      - One form of the influenza vaccine is a nasal spray. It uses a live but weakened flu virus.     Researchers want to better under how the live vaccine interacts with the body s immune     system. They will test the nasal spray flu vaccine (called FluMist) against a saline (salt     water) nasal spray. They will then look at blood and nasal cell samples to see how the     vaccine affects these cells immune response.      Objectives:      - To look at immune changes in nasal and blood cells in people who receive live flu vaccine.      Eligibility:      - Healthy volunteers between 18 and 49 years of age.      Design:        -  Participants will have five outpatient visits for this study. Each visit will last up to          2 hours.        -  At the first visit, participants will have a physical exam and medical history. They          will give blood and urine samples. Nasal cell samples will also be collected.        -  A week later, participants will have either the nasal spray flu vaccine or a saline          spray. They will know which spray they will receive. Blood samples will be collected.        -  Two days after the vaccination, they will have another physical exam. Blood and nasal          cell samples will be collected.        -  At the final two visits (1 week and 1 month after the vaccination), more blood samples          will be collected.        -  Those who had the saline spray will be able to have the actual vaccine spray at the last          study visit.        -  The ratio of participants who receive vaccine to those who receive saline will be 4:1.   "
119154|NCT01726283|"     This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced     cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and     biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that     are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that     will be undergoing laser vision correction.   "
118923|NCT01729325|"     Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and     are often exposed to multiple traumatic events and situations in which they are forced to     engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to     reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other     mental disorders as a result of traumatic experiences. The effective prevention of mental     disorders as a result of war deployment is expected to facilitate reintegration in civil life     after deployment and reduce uncontrolled violence.   "
118861|NCT01730131|"     Background:      - Progressive multifocal leukoencephalopathy (PML) is a severe viral infection of the brain.     It is caused by JC virus. Many people have this virus in their bodies all their life, but it     is usually kept in check by their immune system. If the immune system does not work right     because of a disease or medication, the virus becomes active and can damage cells in the     brain. Not much is known about PML or how it affects the immune system. Researchers want to     study people with PML to better understand the natural history of the disease.      Objectives:      - To study the natural history of PML.      Eligibility:      - Individuals at least 2 years of age who have PML.      Design:        -  Participants will be screened with a physical exam, medical history, and imaging          studies.        -  Participants will have several visits to the National Institutes of Health Clinical          Center. There will be an initial visit, monthly visits for the next 6 months, a 12-month          visit, and possible visits afterward.        -  At the initial visit, participants will give blood, urine, and spinal fluid samples.          They will also have neurological tests and imaging studies of the brain.        -  For the next five visits, participants will give blood and urine samples. They will also          have neurological tests and imaging studies of the brain.        -  The 6-month and 12-month visits will repeat the tests from the initial visit.        -  Other optional procedures include bone marrow samples and skin biopsies. Additional          blood tests and imaging studies may be performed.        -  Treatment will not be provided as part of this study.   "
118862|NCT01730118|"     Background:      - HER2/neu (HER2) is a tumor protein that appears in almost a third of breast cancers and in     several other types of cancers such as colon, prostate and non-small cell lung. Tumors that     overexpress HER2 can be associated with a more aggressive cancer, higher recurrence rates,     and reduced survival rates. Researchers are testing a therapeutic cancer vaccine designed to     stimulate the immune system to recognize HER2. The vaccine, called AdHER2/neu dendritic cell     vaccine, is custom-made using an individual s own immune cells. These cells will be collected     and used to produce the vaccine.      Objectives:      - To test the safety and effectiveness of AdHER2 vaccination.      Eligibility:      - Individuals at least 18 years of age who have HER2-expressing tumors.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies will also be performed.        -  Participants will have an apheresis procedure to collect immune cells to create the          vaccine.        -  Participants will receive four doses of the vaccine at study Weeks 0, 4, 8, and 24.        -  Participants will be monitored with physical exams, frequent blood tests and imaging          studies....   "
118863|NCT01730105|"     Background:      - Researchers are studying how metabolism and hormone levels change in response to mild     changes in environmental temperature. Changes in metabolism may lessen with time because of     hormonal adaptations. If this increase in metabolism continues for a longer period, mild cold     exposure may cause weight loss. It is unclear whether exposure to a warmer temperature may     cause opposite changes in metabolism. Researchers want to see if longer exposure (1 month) to     different temperatures can affect how the body uses energy.      Objectives:      - To test changes in energy metabolism in response to different room temperatures.      Eligibility:      - Healthy men between 18 and 40 years of age.      Design:        -  The entire study will last for 4 months. It will involve a screening visit and a 4-month          inpatient stay at the National Institutes of Health Clinical Center. The inpatient stay          will be in a private room at the Metabolic Clinical Research unit. Study participants          will be required to stay in the Metabolic Clinical Research unit during the night, but          are free to leave during the day.        -  At the screening visit, participants will have a physical exam and medical history.          Blood samples will be collected. A heart function test and diet questionnaire will also          be given.        -  During the first month, the temperature of the private room will be set at to 75.2          degrees F. This will allow the body to become used to the testing environment.        -  During the second month, the temperature will be set to either a cool (66.2 degrees F)          or a warm (80.6 degrees F) temperature.        -  During the third month, the temperature will return to 75.2 degrees F.        -  During the fourth month, the temperature will be altered to the opposite temperature to          the one set in the second month.        -  Throughout stay, participants will have daily temperature monitoring and will keep a          food diary. Once a week, they will collect all of their urine for 24 hours. Once a          month, they will spend 24 hours in a metabolic suite to study their metabolism rate.        -  Throughout stay, the food will be provided as part of the study.        -  During the first and third month (75.2 degrees F) the participants will be allowed to          leave the Metabolic Clinical Research unit during the weekends, while during the second          and forth month (66.2 or 80.6 degrees F), the participants will be allowed to spend one          weekend out of the Metabolic Clinical Research unit.        -  Other tests, such as body scans, fat tissue samples, and imaging studies, will be          performed as needed.   "
118864|NCT01730092|"     Background:      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare     disorder. Some people have disease-associated PAH and some have PAH from an unknown cause.     Researchers want to follow the natural history of all PAH patients to understand how PAH     progresses in order to discover targets for future research into new treatments. To further     identify treatment targets, they will compare healthy volunteers to patients with PAH.      Objectives:      - To study the natural history of PAH.      Eligibility:        -  Individuals at least 18 years of age who have PAH.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants with PAH will have periodic visits to the National Institutes of Health          Clinical Center. After the first visit, they will return in 6 months and then yearly or          every other year for as long as the study continues.        -  The first visit will take up to 3 days. It will involve the following tests:        -  Physical exam and medical history        -  Blood and urine samples        -  Heart and lung function tests and imaging studies        -  Six-minute walk test        -  Questions about exercise and physical activity        -  Healthy volunteers will have only one visit to the Clinical Center, during which they          will undergo screening tests, and complete many of the same tests as patients with PAH   "
118865|NCT01730079|"     Background:      - Near-infrared spectroscopy (NIRS) is a functional imaging technique that can be uses light     to study brain function while allowing for movement. To look at blood flow in the brain, NIRS     uses a low-power light source with detectors that see how the light changes as it passes     through brain tissue. Brain blood flow can indicate which parts of the brain are active     during different tasks. Researchers want to study children with attention deficit     hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) and will use NIRS to     compare the blood flow in the brain of children with ADHD and ASD with that of typically     developing children.      Objectives:        -  To see how well NIRS can detect changes in brain blood flow during tests of thinking and          memory in children.        -  To compare blood flow in the brains of typically developing children and those with ADHD          or ASD.      Eligibility:      - Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric     diagnoses.      Design:        -  Participants will be screened for eligibility. Those who are taking stimulant medication          for ADHD or ASD will need to stop taking it for 3 days before the study visit.        -  After participating in a screening assessment, all participants will have one study          visit. At this visit, they will have be asked to complete two tasks during a NIRS scan.          For both tasks, they will react to images on a computer screen. This visit will last          about 2 hours.        -  This is a testing study only. No blood or other samples will be needed for this study.   "
118866|NCT01730066|"     Surgery in the mouth and oropharynx is performed in an area colonised by bacteria     non-pathogenic and pathogenic.      Antibiotics are used regularly resulting in disturbances in the intestinal microbiological     flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout     the hospital stay for these difficult cases represent a risk of development of resistant     strains.      Most of the patients have cancer diagnoses and have radiation therapy before surgery. This     increases the risk of the patients having pathogenic bacteria normally present in the lower     GI-tract.      The investigators have shown for ICU patients that treatment with probiotics reduces the     number of emerging enteral bacteria in the oropharynx and now the investigators will perform     an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.      Patients will preoperatively gurgle a suspension of probiotics and then swallow the     preparation.      Postoperatively the probiotics is given enterally and a eventually by mouth again.      Cultures will be taken from the oropharynx and tracheal secretions and the results will be     compared   "
118867|NCT01730053|"     To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab     (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia     at high cardiovascular (CV) risk.   "
118868|NCT01730040|"     This is a randomized, double-blind, active-comparator, parallel-group study in patients at     high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial     hypercholesterolemia (heFH).   "
118869|NCT01730027|"     This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety     of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when     co-administered with montelukast in patients with inadequately-controlled asthma. Patients     will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.   "
118870|NCT01730014|"     This trial is conducted in Europe. The aim of this trial is to investigate safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and     pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous     NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes   "
118871|NCT01730001|"     This study looks at advanced airway management in critically ill or injured patients treated     by physician manned emergency medical services, comparing early (on-scene) intubation to late     (emergency department) intubation.   "
118872|NCT01729988|"     This is a pilot study to assess the effectiveness, safety and feasibility of carotid body     removal in patients with high blood pressure (hypertension) resistant to medical treatment.     Patients with high blood pressure are at significant risk of medical complications including     stroke and heart disease. The principle research question is whether removal of the carotid     body will lead to an improvement in the blood pressure of this patient group.   "
118873|NCT01729975|"     The primary objective of this clinical study is to collect clinical data to support an FDA     510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to     evaluate any adverse events found during the clinical study.   "
118874|NCT01729962|"     The primary purpose of this comparative clinical study is to collect clinical data to     demonstrate the equivalence of the investigational device to the predicate device for     measurements of the eye. The secondary purpose is to evaluate any adverse events that occur     during the clinical study.   "
118875|NCT01729949|"     1. The primary objective is to determine the effect of fruit polyphenols on postprandial          lipoprotein triglyceride metabolism after consumption a standard high carbohydrate/fat          breakfast meal with a beverage rich in fruit-derived polyphenols compared to energy and          macro-/micro-nutrient matched control beverage (acute, Part 1).        2. Secondary objectives are: 1)to assess the effects of consuming daily for 8 weeks          (chronic, Part 2) a beverage rich in fruit polyphenols compared to an energy and          macro-/micro- nutrient matched control beverage on fasting glucose, insulin, lipids and          markers of oxidative stress; and 2) to assess the effects of these beverages on          meal-related changes in metabolic and oxidative stress measures after 8 weeks daily          consumption.   "
118876|NCT01729936|"     Primary care centres are a key setting to treat people with overweight and moderate obesity.     There is growing evidence that sitting for a long time is negatively associated with people's     health. Interventions with the aim of reducing daily time of sedentary activities can be an     effective strategy to increase daily energy expenditure. To improve the effectiveness of     programmes promoting physical activity in primary care we need some clear action protocols     that can be easily integrated in the daily routines of primary care professionals.      Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary     care intervention to reduce diary hours of sitting time in overweight and obese sedentary     patients, as well as to increase their weekly caloric spend.      Methods. The design of the study is a simple randomized controlled trial. Ten primary care     centers will be invited to participate and will be randomized into control (CG) and     intervention group (IG). Each professional will randomly invite to participate voluntarily     moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and     65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200     individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be     included in the study to know the feasibility of the intervention among them.      The main dependent variable (sitting times) will be measured with an ActivPAL during first     and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of     the intervention. Other variables included in the study: number of steps walked, subjective     level of physical activity, weight, height, BMI, skinfolds, waist circumference,     triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood     pressure and quality of life related to health. A descriptive analysis of all variables and a     multivariate analysis to assess differences among intervention and control group will be     undertaken. Multivariate analysis will be carried out to assess time changes of dependent     variables. All the analysis will be done under the intention to treat principle.   "
118877|NCT01729923|"     This phase II trial studies how well capecitabine and celecoxib with or without radiation     therapy works in treating patients with colorectal cancer that is newly diagnosed or has been     previously treated with fluorouracil, and has spread to other parts of the body (metastatic).     Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving capecitabine and     celecoxib together with radiation therapy may kill more tumor cells.   "
119155|NCT01726270|"     Multicenter trial conducted in Pharmacy retail centers   "
119156|NCT01726257|"     The objective of this study is to assess the safety and effectiveness of the Endologix     Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).   "
119169|NCT01726075|"     To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)     are able to prevent or arrest the development and progression of neurodegenerative changes   "
118878|NCT01729910|"     Child overweight has become one of today's most important public health concerns. Engaged and     skilled parenting that models, values, and encourages healthy eating habits and a physically     active lifestyle can play a key role in childhood overweight prevention and reduction.     Primary care providers are well positioned to intervene with children and their parents, but     face many barriers in addressing child overweight. A child overweight treatment approach is     proposed for the primary care setting to facilitate parents' active involvement and     self-efficacy in promoting healthy eating habits and physical activity for their children. We     will test the following hypotheses: Hypothesis I (primary hypothesis): Children assigned to     the intervention group will improve more in weight status (measured by BMI percentile) than     children in the control group. Hypothesis II: Primary care providers assigned to the     intervention group will improve more in their competence in addressing child overweight than     the providers in the control group. Hypothesis III: After the intervention, parents in the     intervention group will have more involvement and self-efficacy in promoting healthy weight     for their children than parents in the control group. Hypothesis IV: Compared to the control     group, the intervention group will improve more in family diet and eating, physical activity     behaviors, as well as parental attitude and beliefs. Eighty children five to eleven years old     who are overweight or obese will be recruited from two pediatric and two family practice     clinics in southern Appalachia. Children will be randomly assigned to intervention and     control groups based on clinic affiliation. Parents of children in the intervention group     will participate in four clinic-based group sessions using the NIH We Can! curriculum     moderated by a trained clinic provider, two individual brief motivational interviewing visits     with their clinic provider, and four follow-up phone calls with the project coordinator or     registered dietician. Parenting behaviors and attitudes, and family eating and activity     habits, and children's weight status will be assessed at baseline, at the completion of the     intervention, and at six months after the intervention. Changes in the assessments will be     compared between treatment and control groups. Changes in provider and parent attitudes and     perceptions about this treatment approach,adherence to the program, and estimates of     associated time will be measured.   "
118879|NCT01729897|"     The study is designed to explore and compare the efficacy and safety of etomidate and     propofol with or without analgesic for painless gastroscopy, and to provide more reliant     support for implementation and promotion of comfort care.   "
118880|NCT01729884|"     This phase II trial studies how well vaccine therapy works in treating patients with stage IV     hormone receptor positive breast cancer. Vaccines made from peptides may help the body build     an effective immune response to kill tumor cells.   "
118881|NCT01729871|"     The purpose of this exploratory study is to evaluate the safety of rivaroxaban and     uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial     fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major     bleeding events.   "
118882|NCT01729858|"     The purpose of this research study is to identify reasons that cause an all-ceramic bridge to     fracture which include the thickness of the bridge material, the type of bridge material and     the bite force of the person. This all-ceramic bridge will be compared to a metal-ceramic     bridge. The investigators are conducting this study so we can make bridges which can     withstand forces in the mouth which tend to break them.      The overall objective of this research is to analyze how properties of ceramic materials and     different forces in the mouth interact with each other to affect the longevity of these     bridges. These include fracture toughness, elastic modulus of ceramic layers and supporting     substrate, core thickness, connector height, wear, loading orientation, and maximum clenching     force.   "
118883|NCT01729845|"     This phase I/II trial studies the side effects and best dose of decitabine followed by     mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in     treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has     returned after a period of improvement or does not respond to treatment. Drugs used in     chemotherapy, such as mitoxantrone hydrochloride, etoposide, cytarabine, and decitabine, work     in different ways to stop the growth of cancer cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Giving more than one drug     (combination chemotherapy) may kill more cancer cells.   "
118884|NCT01729832|"     Many hospitals, including the Ohio State University Medical Center, will take pictures of the     blood vessels in a patient's abdomen before they decide to perform a breast reconstruction     using the patient's own tissue. These pictures are called computed tomography (CT) angiograms     and are like a map of each patient's anatomy. However, no study has been reported that     determined how accurate these pictures are at showing the surgeon where all of the blood     vessels were located. This study will try to determine if these pictures are missing any     blood vessels that are found during surgery and if the pictures show the correct location of     the vessels   "
118885|NCT01729819|"     The purpose of the study is to investigate the efficacy of combining tolterodine and     desmopressin compared with tolterodine monotherapy in the treatment of women with overactive     bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment   "
118886|NCT01729806|"     This partially randomized phase I trial studies the side effects and best dose of ipilimumab     when given together with rituximab in treating patients with B-cell lymphoma that has     returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and     rituximab, may interfere with the ability of cancer cells to grow and spread.   "
118887|NCT01729793|"     The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a     digestive enzyme dietary supplement product, on markers indicative of inflammation after a     meal. The markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha),     interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein     (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal. A full complete blood count     (CBC)and an erythrocyte sedimentation rate (ESR) blood test will also be conducted at times 0     and 4 hours post-meal. In addition, a questionaire on Gastrointestinal symptoms will be     administered 4 hours post-meal. The study hypothesis is that some or all of these potential     markers of inflammation will increase following the meal, and the amount of increase in     inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to     the placebo. In addition, it is hypothesized that levels of gastric discomfort as assessed by     the questionaire will be reduced with the digestive enzyme compared to the placebo.   "
118888|NCT01729780|"     12% of patients suffering from an acute crornary syndrome will develop long lasting anxiety     symptoms. The object of this study is to lessen or prevent these symptoms by the use of     neurofeed back (EEG-NF).   "
118918|NCT01729390|"     The purpose of this research is to determine whether varying the energy density and portion     size of the main course will affect meal energy intake after consumption of a first course     that has previously been shown to enhance satiety. It is hypothesized that increasing either     the energy density or portion size of the main course will increase meal energy intake after     consumption of the first course. It is also hypothesized that compared to when a first course     is consumed, not consuming a first course will increase meal energy intake.   "
119190|NCT01725802|"     In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD     solution (ND0612) on the safety and PK profile of LD will be examined.   "
118889|NCT01729767|"     Meniere's disease is a chronic illness that affects a substantial number of patients every     year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from     minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure.     It has recently been suggested that viral etiologies specially Herpes virus might be the     underlying reason. The investigators study is a randomized, double- blinded     placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective     is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease     specially their vertigo attacks. Inclusion criteria would be patient's willingness to     participate in the study and follow ups, being 18 years old or older, having at least 2     vertigos per month each at least 20 min, interfering with function, and not on medication for     Meniere's disease for at least 3 months before the trial. They should not have any history of     allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic enzymes more     than three times normal, serious uncontrolled illness, be pregnant or nursing or have     previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2 different     arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take the     medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day     for the last 10 days. Patients will report changes in their symptoms 10 days after initiating     the drug and in 1, 3, 6 month intervals.   "
118890|NCT01729754|"     This study is being conducted to evaluate the efficacy and safety/tolerability of     tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe     plaque psoriasis.   "
118891|NCT01729741|"     Thyroidectomy is one of the most commonly performed operations in general surgery. Available     data seem to suggest an association between no-drain usage and a shorter duration of hospital     stay. Seung et al found that the (following thyroidectomy) time to discharge after     thyroidectomy was significantly shorter in the no drain group compared to the drain group.     Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported the     incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%. Tahsin     et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of an     hematoma enlarging and obstructing the airway and causing difficulty in breathing, prompts     many surgeons to use drains routinely after any type of thyroid surgery. The main reason is     to drain off a possible postoperative hemorrhage, which may compress the airway and produce     respiratory fail   "
118892|NCT01729728|"     To find out if a drug called tapentadol administered by mouth safely relieves pain in     children. Look at the amount of tapentadol in the blood after a single oral dose.      Tapentadol oral solution for children is still being tested and is not yet registered.     Tapentadol tablets are effective in treating both acute and chronic pain in adults. This     trial will help to understand how tapentadol oral solution works in children.   "
118893|NCT01729715|"     The investigators are conducting a randomized trial of behavioral treatments for young     children with insomnia. The investigators are comparing the improvement in sleep patterns     after families are given access to Internet sleep instructions compared to DVD sleep     instructions.   "
118894|NCT01729702|"     The primary purpose of this study is to demonstrate that changes in plasma levels of     circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise     correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise     ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)   "
118895|NCT01729689|"     This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in     patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral     therapy may reduce anxiety and improve the well-being and quality of life of patients who     have stage IV non-small cell lung cancer and their caregivers.   "
118896|NCT01729676|"     French epidemiological data have shown a heterogeneous distribution of the risk of mortality     from prostate cancer according to region. The main objective is to describe the distribution     of prostate cancer stages when first line hormonal therapy is introduced (overall and by     region).   "
118897|NCT01729663|"     Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine ,     allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa     2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma     patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos,     Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).      The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de     Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).      Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and     36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.      CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then     one dose every two months for the first year and them every three months for the second year.      Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines,     not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day     and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.      IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for     four weeks and then 5 MU (3t/w) for 23 months.      Both treatments will also compare quality of life (QOL) and study a possible correlation in     the CSF470 vaccine arm between the induced immune response and clinical outcome   "
118919|NCT01729377|"     The purpose of the proposed study is to examine the phenomenon of suicidality in old age and     its unique characteristics. This will be performed through observing the multigenerational     aging family from the life-course perspective, which enables the researchers to address life     transitions, including crises leading to suicidal tendencies.   "
118920|NCT01729364|"     Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients     postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen     demand.   "
118921|NCT01729351|"     To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF     HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically     fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care     asthma population of current smokers.   "
118898|NCT01729650|"     The aim is to evaluate the effectiveness of an intervention based on a program of physical     activity and diet coordinated between primary care teams (PCT) and Mental Health Centres     (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist     circumference in patients with severe mental disorder diagnoses. To assess changes in     cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized     clinical trial with a control group, of one year of follow-up, carried out in four MHC     Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18     - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with     antipsychotic medication and a low level of PA. 240 patients will be selected in each group     (difference to be detected in the BMI:> 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention:     group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8     sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of PA     (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure,     cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED     questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose.     Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for     repeated measures to adjust for differences attributable to the effect of the intervention     for potential confounders: pharmacological treatment, care level of intervention and mental     state.   "
118899|NCT01729637|"     In order to minimize mechanical stress the investigators propose to implement EVLP procedure     with a ventilation monitoring guided by the analysis of the Paw-t shape.   "
118900|NCT01729624|"     A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody     (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure   "
118901|NCT01729611|"     Pulmonary arterial hypertension (PAH) is a condition characterized by an increased pulmonary     vascular resistance that can lead to right heart failure and death. Several diseases are     known etiologies of PAH including scleroderma and cirrhosis. The presence of PAH in the     context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival of     the connective tissue or liver disease.      Despite advances in the diagnosis of PAH, echocardiography remains a necessary test for     screening PAH in patients with scleroderma or cirrhosis. However, echocardiography is less     than ideal for diagnosing PAH and predicting treatment response. Thus, there is a pressing     need to identify methodologies that can accurately and non-invasively recognize the presence     of PAH in patients with scleroderma and cirrhosis.      Hypothesis:        1. To measure endothelial function and exhaled gases in patients with scleroderma and          cirrhosis. To assess whether they correlate with the presence or the development of PAH.        2. The degree of local (forearm) capillary vasodilation during treprostinil iontophoresis          identifies patients who will develop PAH and in those already diagnosed PAH predicts          response to PAH-specific therapies.   "
118902|NCT01729598|"     The purpose of this study is to evaluate the safety of administration and effects of valproic     acid on clusterin expression in cognitively-intact, healthy, elderly subjects. Clusterin     mutations have recently been identified as a risk factor for the development of Alzheimer's     Disease and changes in clusterin expression are seen in the elderly who develop Alzheimer's     disease irrespective of whether they carry these genetic mutations or not. Valproic acid may     prevent or reverse these changes.      Fourteen subjects with normal memory and thinking will participate in this study. Ten of     these subjects will receive valproic acid and 4 will receive a placebo capsule with no     active medicine. Participants will take study medication or placebo for 28 days and be     followed for a total 35 days in this trial.   "
118903|NCT01729585|"     The purpose of this study is to describe the effects of massage therapy on quality of life     (QOL) in youth and young adults (ages 8 to 21 years) with cystic fibrosis (CF).   "
118904|NCT01729572|"     Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing     remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia     outcome remains very limited, mainly due to very poor adherence to medications by the     patients. This study aims to find, whether the add-on of remote monitoring of medication     compliance via tele-medicine, to routine out-patient clinic care, can improve patients     adherence and reduce the risk of relapse.   "
118905|NCT01729559|"     The rate of venous thromboembolic events in trauma patients at high risk for deep vein     thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours     will be equivalent or less than a similar group of patients given a standard every 12 hour     dose of low molecular weight heparin.   "
118906|NCT01729546|"     In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and     several POCT (point-of-care testing) devices against two laboratory methods will be     performed. This evaluation will be performed according to ISO (International Organization for     Standardization) 15197 System Accuracy.   "
118907|NCT01729533|"     The (motile sperm organelle morphology examination) MSOME allows the detection of sperm     vacuoles that seems to be related to sperm DNA damage.      The investigators hypothesized that couples with unexplained infertility could benefit from     the injection of spermatozoa selected under high-magnification (x6600)   "
118922|NCT01729338|"     The primary purpose of this study is to estimate the overall response rate (ORR), defined as     partial response (PR) or better at any time during induction therapy. The success of the     therapy will be determined by ORR with strong consideration given to the secondary endpoints     of tolerability, duration of response, and quality of life (QOL).      All patients will be treated with the same experimental regimen. Several novel features are     being explored: the substitution of cyclophosphamide for melphalan; once weekly AND     subcutaneous bortezomib instead of standard twice weekly, intravenous dosing; and alternating     bortezomib and lenalidomide in maintenance.      The investigators hypothesize that this regimen will prove to be tolerable and effective in     inducing and maintaining remission in a patient population that is historically very     difficult to treat, namely Multiple Myeloma (MM) patients who are too elderly or suffer     comorbidities, such as renal insufficiency, that otherwise complicate aggressive therapies     like autologous stem-cell transplantation (ASCT). In short, the investigators view this as     the Multiple Myeloma trial for non-trial candidates.   "
132851|NCT01546038|"     This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute     Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents     used to treat these diseases.   "
118908|NCT01729520|"     Background:      In the early phase after a total knee arthroplasty (TKA), patients experience multi-level     weakness in the operated leg, which is caused primarily by reduced central nervous system     (CNS) activation failure of the muscles - especially the knee extensors. This considerable     loss of muscle strength relates to reduced functional performance. Early-commenced,     progressive strength training of the knee extensors of the operated leg therefore seems     rational. However, the concern is that this type of early-commenced, intense physical     rehabilitation exacerbates post-operative symptoms, such as knee joint pain.      The investigators have recently reported that early-commenced physical rehabilitation,     including progressive strength training of the knee extensors of the operated leg seems     feasible after TKA. The classic exercise-physiology literature emphasizes loading and     repetitions performed to contraction failure - among others - as important variables for     muscle hypertrophy and strength gains. It is currently not known how loading and repetitions     performed to contraction failure during knee extensions with the operated leg, influences     post-operative knee joint pain in patients with TKA.      Purpose and hypothesis:      The purpose of this study is to investigate how loading and repetitions to contraction     failure influence knee joint pain during knee extensions with the operated leg early after     TKA.      The hypothesis is that knee pain increases with increasing loading and fatigue.      Methods:      Fifteen patients with a unilateral TKA, operated between 1 to 2 weeks prior to the first     investigation, will be included. The participants are investigated twice. During the first     investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a     load that can be lifted exactly 10 times) will be determined for unilateral (operated leg)     knee extension. At the second investigation, at least 72 hours later, the patients will     perform 1 set of 4 repetitions with a relative loading of 8, 14, and 20 RM each, in a     randomized order, estimated from their 10 RM test at the first investigation. Time under     tension (contraction velocity) and range of knee joint motion for each repetition will be     controlled for. During the concentric phase of each repetition, the patients rate their knee     joint pain verbally, using a numerical rating scale placed 1 meter in front of them. After a     short break, the patients perform 1 set of knee extension with a relative loading of 10 RM     until of contraction failure. As for the loading effect described above, they rate their knee     joint pain during the concentric phase of each repetition.   "
118909|NCT01729507|"     As an add-on treatment to behavioural therapy for tobacco dependence, anodal transcranial     direct current stimulation (tDCS) significantly increases the cessation rate compared to     treatment with sham tDCS; endpoint analysis will be performed 1, 3, 6 and 12 months after     completion of the smoke-free programme in combination with tDCS.      Craving, assessed with a visual analog scale (VAS), is reduced significantly in the verum     treatment group compared to the sham tDCS group.      tDCS is suitable for use in larger groups (8-12 people).   "
118910|NCT01729494|"     The study purpose is to determine the safety and efficacy of a belatacept-based     immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit     antithymocyte globulin induction and early glucocorticoid withdrawal (CSWD) and a     belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit     antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant     recipients.      The hypothesis is that a belatacept-based immunosuppressive regimen with alemtuzumab     induction, MMF/MPA, and early glucocorticoid withdrawal (Group A) in renal transplant     recipients or Belatacept-based immunosuppressive regimen with rabbit antithymocyte globulin     induction, MMF/MPA and early glucocorticoid withdrawal (Group B) will lead to less risk of     graft loss, patient death, or reduced renal function at 12 months as compared to a     tacrolimus-based immunosuppressive regimen with rabbit antithymocyte globulin, MMF/MPA, and     early glucocorticoid withdrawal in renal transplant recipients (Group C).   "
118911|NCT01729481|"     In the current study it is examined whether patients with good risk factors (age <75 years,     total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with     gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of     treatment have a comparable outcome as patients who receive FOLFIRINOX.   "
118912|NCT01729468|"     The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given     bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous     pregnant women selected as high-risk by the presence of a bilateral uterine artery notch     and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6     weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.   "
118913|NCT01729455|"     The purpose of this registry is to collect additional information regarding the side effects     and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults     with active systemic lupus erythematosus (SLE). Information will be collected on serious     events that are not that common or may only be seen with long-term treatment. These events     include death, cancers, serious infections and other infections of interest, and serious     mental health problems. Information on the effectiveness of BENLYSTA will also be collected.   "
118914|NCT01729442|"     Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for     prostate cancer that is currently assessed in two indications: as a first-line treatment     (either total or focal) for patients who are not eligible for surgery and as a salvage     treatment of local recurrences after radiotherapy.      It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the     position and volume of tissue destruction at the end of prostate HIFU ablation. This can     provide live feedback regarding the amount of residual non ablated tissue after HIFU     treatment, which could allow immediate re-treatment in case of unsatisfactory result.      CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan,     Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is     necessary to wait 20 to 30 minutes before re-treating the patient.      Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can     quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than     undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose     of this study is to evaluate the accuracy of SWUE in depicting the position and volume of     therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation.      The present study is an exploratory, monocentric, prospective, descriptive study. Three     groups of 10 patients with prostate cancer will be evaluated: patients referred for     first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal     treatment) and patients referred for salvage HIFU after radiotherapy.      SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation     (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and     D0 SWUE.      The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by     SWUE and CEUS.      The secondary endpoints are:        -  The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0          and D+1,        -  Adverse events related to SWUE.      The study will last 40 months.   "
118915|NCT01729429|"     This randomized controlled trial is designed to evaluate whether a behavioral intervention     that includes three components: 1) reminder letters and education materials delivered before     the clinic visit, 2) telephone recalls after the visit for those who originally decline the     vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1     and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls     attending four Parkland primary care clinics in Dallas county.      Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the     Intervention group than those in the General Adolescent Vaccine Brochure group.      Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among     patients in the Intervention group who initially declined the vaccine than those in the     General Adolescent Vaccine Brochure group who initially declined.      Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the     Intervention group than those in the General Adolescent Vaccine Brochure group.   "
118916|NCT01729416|"     The purpose of this study is to determine if screening colonoscopy performed on adults with     the water exchange method, as opposed to the air method, will have a higher adenoma detection     rate.   "
118924|NCT01729312|"     To make reading this consent form easier, the word participant refers to you or your child     (if a minor) throughout the consent form. This research is being done to study the effects of     an eighteen-session strengthening program and to see if there is a relationship between the     female athletes improving their landing techniques which has been proven to decrease anterior     cruciate ligament injuries.      Participants have been asked to take part in a research study because you are a female     athlete involved in a sport that has an increased anterior cruciate ligament injury rate. The     purpose of this research study is to find out if an eighteen-session strengthening program     will decrease your anterior cruciate ligament injury rate.      There will be approximately ninety-four (94) people in this research study at Henry Ford     Health System (HFHS).   "
118925|NCT01729299|"     To determine the role of nutrient status on ghrelin regulation of insulin secretion. We     hypothesize that ghrelin and glucagon-like peptide-1 (GLP-1)(both are hormones made in the     gut,) have differential effects on β-cell function in the fed state. We will compare insulin     secretion and glucose turnover during meal ingestion using a dual glucose tracer and mixed     meal protocol in subjects receiving ghrelin or saline. We will also determine the role of     ghrelin-stimulated GLP-1 levels in this process using the GLP-1 receptor (GLP-1R) antagonist     Exendin(9-39) (Ex-9).   "
118926|NCT01729286|"     The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy     (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects     with diabetes mellitus and without significantly compromised arterial circulation.   "
118927|NCT01729273|"     The purpose of this study is to assess exercise performance in 20 healthy children 10-19     years of age with a body mass index greater than 85th percentile and to evaluate the effect     of dietary and exercise intervention over 12 weeks.   "
118928|NCT01729260|"     The purpose of this study is to find the highest dose of mebendazole (MBZ) that can be safely     given to people with malignant brain tumors in combination with the current standard of care     (temozolomide) without causing severe side effects. We also want to find out if MBZ can slow     the growth of the brain tumor. The study doctors have found that MBZ is effective against     malignant brain tumors in the laboratory and animal models of brain tumors.   "
118929|NCT01729247|"     Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions.      Secondary objectives: Evaluate the ability of physicians to correctly assess airway     inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement).     Estimate the cost consequences of changes in asthma management following FeNO determinations      Number of participants: Approximately 40 to 50 subjects will participate in the study during     an (approximately) 8-12 week study enrollment period.      Reference product: NIOX MINO® Instrument (09-1100)      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be     performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO®     User Manual (February, 2011).      Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4)     FeNO has been measured and seen by the Physician/Health Care Practitioner.      Safety assessments: The Investigator is responsible for the detection, reporting, and     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious     Injuries as provided in this clinical investigation plan (CIP) from the time that informed     consent has been provided and during the study period      Criteria for evaluation: This is an observational, pilot study and there are currently no     plans for a formal statistical analysis. Information gained from this study may be used to     design subsequent studies in subjects with asthma. Data collected will be summarized in a     clinical study report but will not be subject to formal hypothesis testing   "
118930|NCT01729234|"     Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular     function in healthy volunteers with particular emphasis on age-related alterations.   "
118931|NCT01729221|"     Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C     virus infected patients after stem cell therapy.   "
118932|NCT01729208|"     The purpose of this study is to determine whether a new type of soft contact lens with a     unique optical design (dual focus) is effective at slowing the progression of myopia     (near-sightedness) in children.   "
118933|NCT01729195|"     This single-center randomized trial evaluates the efficacy and safety of a new bone screw     (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber     C-type ankle fractures. The comparison is made to subjects treated by conventional metal     screw fixation of the syndesmosis. The primary objective is to show that the antibiotic     releasing bioabsorbable screw is at least as good as the routinely used metal screw in     prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The     secondary objective is to show that the clinical outcome of the ankle fracture treatment is     equal between patients treated by the antibiotic releasing bioabsorbable screw and the     conventional metal screw.   "
118934|NCT01729182|"     The purpose of this investigation is to collect following data in patients given Nexium     capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of     gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).   "
118951|NCT01728961|"     The purpose of this study is to see if taking nevirapine (NVP) for HIV changes the way     artemether/lumefantrine (AL) works in children who are co-infected with both HIV and malaria.     The brand of AL used in this study is Coartem® Dispersible. This study will compare the blood     levels of AL in co-infected children who already take NVP prescribed by their doctor with the     co-infected children who do not take anti HIV medicines because they do not meet national     guidelines to start them. The study will also assess the safety of using both medications (AL     and NVP) in children.   "
133399|NCT01538849|"     This study is to investigate the optimal clinical dose and administration methods of YH4808     in patients with reflux esophagitis by evaluating the safety and efficacy after YH4808 oral     administration.   "
118952|NCT01728948|"     This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65     years, no prior systemic treatment, determined to be candidates for systemic therapy by the     investigator. The treatment with Sorafenib should comply with the recommendations written in     the local product information. The primary endpoint is overall survival. The secondary     endpoints including other effectiveness points, safety and patients characteristics. With 120     completed patients, if the observed survival rate at 12 months is 60%, the width of a 95%     confidence interval will be approximately 18%.   "
118935|NCT01729169|"     Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has     proved effective and cardiac biopsies have a very low sensitivity.     18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of     fasting has previously been demonstrated to have reasonable accuracy, however, in some     patients physiological FDG uptake in the cardiac region hampers correct identification of     sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue     Nal3-octreotide (NOC) and gallium Ga 68-labeled     1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether     68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac     sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with     18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.   "
118936|NCT01729156|"     Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism.     Whereas there is general agreement that the blood glucose lowering effect of metformin     results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug     lowers blood triglyceride concentration. There are indications that it enhances hepatic free     fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as     very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily     accessible for sampling in humans and data on the clinical effects of metformin in the liver     are therefore lacking. This may change due to the increasing use of the positron emission     tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a     fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.      Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic     lipid metabolism in patients with newly diagnosed type 2 diabetes.      Design: Randomized, placebo controlled, double-blind parallel study with patients receiving     either metformin or placebo. A control group of BMI and age-matched healthy controls will     receive metformin for 3 months.      Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing     hepatic fatty acid oxidation   "
118937|NCT01729143|"     As obesity rates worldwide continue to increase, there is a focus on identifying active food     ingredients which increase metabolic rate which can be used as a dietary supplement in the     treatment of overweight and obesity. Promising animal and cell studies have suggested a role     for black pepper and an active component of black pepper, piperine, in energy expenditure.     However, the effects of black pepper have not been determined in humans. The investigators     hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one     day) will result in an elevation in 24-h resting energy expenditure when contrasted to a     control day (no black pepper, same diet intake).   "
118938|NCT01729130|"     Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do     not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is     a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular     disease (CVD). These biomarkers also can become additional outcome measures for an     intervention such as pancreatic/kidney transplant. If biological markers show an improvement     with an intervention before anthropometric changes occur, intermediate outcomes can be an     encouraging finding for practitioners. This study will focus on the central question of     adipose tissue dysfunction as mediator of metabolic complications of positive energy     balance, independent of body fat content and distribution. This study will address the     question of effect of hyperglycemia on adipose tissue function independent of body fat mass.     This project will take advantage of unique expertise of our investigators to perform detailed     metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The     results of the proposed study will provide support to the novel approach of identifying     adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of     diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary     preliminary data for future grant submissions to support our central hypothesis and develop     stronger interactions within and outside The University of Texas Medical Branch (UTMB) with     clinical investigators in the area of DM and its complications.   "
118939|NCT01729117|"     Background and Rationale Research studies have shown that patients with type 2 diabetes     (T2DM) who lose weight have better glucose control and less risk for heart disease. It has     been difficult to achieve these results in a non-research setting. Meal replacements (MR) are     pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight     loss program by reducing decision-making and facilitating target caloric intake. The     University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal     Clinic has demonstrated acceptability and success of MRs in conjunction with a structured     lifestyle modification program in achieving weight loss in underserved Hispanic T2DM     patients.      Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a     3-month full MR program in conjunction with a 1 year standardized lifestyle modification     program in a clinic setting. Our longer-term goal is to acquire data for sample size and     power estimates for a larger NIH- or other funded prospective, randomized trial.      Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated     with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The     SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive     MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1     consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month     transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of     a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600     calories/day for women and 1800 to 2000 calories/day for men. Individual and group     educational, support and counseling visits will be components of all 3 phases of the study.      Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to     hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and     12 months. These are all measurements that are done routinely in these patients. Safety will     be determined by monitoring of adverse events.      Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to     determine if there is evidence that the intervention improves outcomes and is safe.   "
118940|NCT01729104|"     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of     carfilzomib that can be given in combination with lenalidomide and rituximab to patients with     relapsed or refractory B-cell non-hodgkin lymphoma.      The goal of Part 2 of this study is to learn if the drug combination can help to control     B-cell non-hodgkin lymphoma.      The safety of this drug combination will be studied in both parts.      Carfilzomib is designed to keep cancer cells from repairing themselves. If the cancer cells     cannot repair themselves, this may cause them to die.      Lenalidomide is designed to change the body's immune system. It may also interfere with the     development of tiny blood vessels that help support tumor growth. This may decrease the     growth of cancer cells.      Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer     cells to die. It is also designed to cause the immune system to attack cancer cells.   "
118941|NCT01729091|"     The goal of this clinical research study is to find the highest tolerable dose of immune     cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell     transplant to patients with high-risk myeloma. Researchers want to learn if adding NK cells     will help make the stem cell transplant more effective in treating the disease. The safety of     this treatment will also be studied.      NK cells may kill myeloma cells that remain in your body after your last chemotherapy     treatment. The NK cells are separated from the umbilical cord blood sample. These separated     NK cells will then be grown (manipulated) in the lab to increase the number of NK cells     that can be given to you by vein.      Elotuzumab is designed to directly activate NK cells, that may help kill myeloma cells.      Lenalidomide (Revlimid) is designed to block a protein that plays a role in cell function and     growth, which may cause cancer cells to die.      Melphalan is designed to attach to the DNA (genetic material) of cells, which may cause     cancer cells to die. It is commonly used in stem cell transplantation.   "
118942|NCT01729078|"     Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre     diabetes subjects. Subjects will be randomized to either high fat (olive oil     supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets.     Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by     magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary     intervention.   "
118943|NCT01729065|"     This study will determine whether patients who receive regular physical therapy immediately     following a modified neck dissection surgery will report decreased shoulder disability,     decreased pain, improved or maintained shoulder range of motion and strength, and improved     quality of life than those who receive only home instruction.   "
118944|NCT01729052|"     Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.     However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant     adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is     appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are     minimal.      The objective of this multicentre, double-blinded, randomized, controlled trial is to     investigate whether acupuncture can be a supplementary to the ordinary treatment in children     undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of     parental attitudes and expectations on the outcomes will be explored.      Two hundred and eighty patients will be included and randomized into two groups        1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during          anaesthesia and standard treatment        2. Control group: standard treatment      The primary endpoints in the intervention study are nausea, retching, vomiting and pain     during 24 hours postoperatively. The effect of acupuncture will be studied with regard to any     association with possible factors of predisposition to PONV, as well as with other factors     registered during the study. Adverse events from acupuncture will be registered.      The objective of the self-report questionnaires is to        -  investigate parental attitudes and expectations to the acupuncture treatment pre- and          postoperatively        -  compare data of the outcomes from the intervention trial with data from the          questionnaires, in order to find any correlation between parental beliefs, attitudes and          expectations, and the effect of the acupuncture treatment   "
118945|NCT01729039|"     The purpose of this study is to determine whether vestibular exercises provide added benefit     to balance rehabilitation in older adults with dizziness and normal vestibular function.   "
118946|NCT01729026|"     The purpose of this study is to provide preliminary data on the feasibility and impact of     adopting a dog from an animal shelter as a supplement to usual care in Veterans with     Posttraumatic Stress Disorder (PTSD) who desire to get such a pet.   "
118947|NCT01729013|"     Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin     D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues.     The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such     storage which may potentially be of vital importance when intake or solar exposure is     limited. In the present study we will include 76 subjects who have participated in an     intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of     type 2 diabetes, and who have completed the study after 5 years or who have been excluded     because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any     extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a     considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D     during the following year without vitamin D substitution, which will be measured in the     present study. If our hypothesis is correct, that vitamin D can be stored in significant     amounts when the supply is abundant; current advice on vitamin D supplementation mainly     during winter should be changed to year around in order to build up sufficient stores for     the months without sufficient sun light.   "
118948|NCT01729000|"     The purpose of this study is to compare the additional use of gloves (with handwashing before     and after gloving) for all patient contact while infants have intravenous (central or     peripheral) access in a RCT. Preterm infants <1000 grams or less than 29 weeks gestational     age will be randomized after birth to either a handwashing-gloving group or handwashing only     group. The primary outcome will be the incidence of invasive infections (bacterial or fungal)     or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm     morbidities, mortality, and hospital costs.   "
118949|NCT01728987|"     The study will examine the role of adipose tissue in vitamin D physiology, particularly its     role as a depot. the study is randomized double blind and placebo controlled.   "
118950|NCT01728974|"     In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms     that lead to airway closure are not completely understood. While the airway of some people     narrows and airflow decreases during inspiration due to increasing inspiratory effort, others     maintain constant airflow throughout inspiration. Airway neuromuscular reflexes may protect     against airway narrowing that occurs due to increasing inspiratory effort. To test this     hypothesis, the investigators will initially measure airway neuromuscular reflex and     inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal     anesthesia to observe the effects on inspiratory flow.   "
125823|NCT01638130|"     The purpose of this study is to explore the experiences and needs of patients with a     high-grade glioma and their caregivers. Semi-structured interviews with patients and     caregivers will be conducted and analysed using Grounded-Theory approach.   "
118953|NCT01728935|"     Tenofovir (TDF) has been demonstrated to have potency antiviral against the hepatitis B virus     (HBV) in various multiple-centre trials, with no cases of resistance encountered. However,     its efficacy and resistance profile in the Asian population, which constitute the majority of     chronic hepatitis B (CHB) patients, is unknown. Compared to other nucleoside analogues, TDF     has been associated with relatively high rates of hepatitis B surface antigen (HBsAg)     seroclearance. It would be interested to see if this could be reproduced. The investigators     plan to report the serologic and virologic results of our 140 nucleoside analogue-experienced     patients who were commenced on TDF.   "
118954|NCT01728922|"     The primary purpose of this study is to assess the immune response to vitamin D     supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and     patients with clinically isolated syndrome compared to placebo. Secondary endpoints include     (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and     evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used   "
118955|NCT01728909|"     The purpose of the study is to examine the effects of intranasal oxytocin administration on     social cognition in patients receiving methadone maintenance treatment (MMT), examine the     effects of intranasal oxytocin administration on opioid craving and on the subjective effects     of methadone, and examine the effects of intranasal oxytocin administration on implicit     preferences for drug-related and social stimuli in patients receiving MMT.      Hypothesis 1: Patients will perform better on measures of social cognition (including affect     recognition and recognition of sarcasm) after administration of oxytocin compared with     placebo.      Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective     effects of methadone after administration of oxytocin compared with placebo.      Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and     decreased implicit preferences for drug related stimuli after administration of oxytocin     compared with placebo.   "
118956|NCT01728896|"     The first step in treating patients with acute pancreatitis is to provide pain relief and     intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel     better food and fluids by mouth are restarted. This is done to rest the pancreas which is the     organ that has been inflamed.      In some patients when food by mouth restarts they have pain and as a consequence they have a     longer stay in hospital. It is thought that patients who have little pain and are within 24     hours of admission to hospital do well if they control their own food intake. This is in     contrast to the usual treatment where the treating team advise when eating should restart.   "
118957|NCT01728883|"     The purpose of this study is to determine the effect of enhancements to the myVisionTrack® in     regards to patient compliance and test-retest variability. Additionally, the ability of     myVisionTrack® to detect changes in vision function will be evaluated.   "
118958|NCT01728870|"     The purpose of this study is to assess the efficacy and tolerability of a novel dietary     intervention for early CD based on partial enteral nutrition, and to compare it to the gold     standard but difficult to implement dietary intervention- Exclusive enteral nutrition with     Modulen .   "
118959|NCT01728857|"     Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the     outcome of non-invasive fat reduction using the ZELTIQ System.   "
118960|NCT01728831|"     This proposal aims to provide some objective, non-invasively achieved, physiologically     relevant data in order to provide some rational basis for decision-making for transfusion in     sTBI. Specifically this proposal is an observational study of transfusion and brain tissue     saturation in sTBI patients. The results will illustrate to what degree brain tissue     oxygenation is critically dependent on the degree of anemia in sTBI and help in the decision     of whether transfusion might be helpful.   "
118961|NCT01728818|"     Single-agent gemcitabine is currently still regarded as one international standard of care     for patients with advanced pancreatic cancer (Burris 1997 [4]). The oral EGFR tyrosine kinase     inhibitor erlotinib received EMEA-approval for the treatment of patients with metastatic     pancreatic cancer in January 2007.      In the pivotal phase III trial, the combination of gemcitabine plus erlotinib was associated     with a statistically significant prolongation of OS (compared to single-agent gemcitabine),     however, the absolute survival benefit was - for the overall study population - clinically     moderate (median OS: 6.24 vs 5.91 months, 1-year OS rate: 23% vs 17%; HR = 0.82, p=0.038)     (Moore 2007 [19]).      The recently presented FOLFIRINOX regimen shows enhanced activity in metastatic pancreatic     cancer patients. This regimen is, however, limited to patients with good performance status     (ECOG 0-1), no major comorbidity, age <75 years, and bilirubin <1.5 ULN (Conroy 2011 [6]).     The majority of pancreatic cancer patients will therefore not be treated with this regimen.      Accordingly, novel treatment concepts are urgently needed in pancreatic cancer and     pre-clinical data indicate an important role of the EGFR1/erbB2 receptor signalling in the     pathogenesis of pancreatic adenocarcinoma (Yeh 2007 [24]). A recent publication (Larbouret     2010 [16]) indicates that the combination of cetuximab and trastuzumab induced superior     antitumour activity in human pancreatic carcinoma xenografts compared to gemcitabine alone     (see also Larbouret 2007 [15]). Furthermore, synergistic antitumour activity was observed     when monoclonal antibodies directed against the EGFR1 and erbB2 were combined (Ben-Kasus 2009     [3]). Based on these data, there is a good rationale to further investigate the combined     inhibition of the erbB family in pancreatic cancer patients.      Afatinib (BIBW 2992) is a novel irreversible EGFR1- and HER2 and HER4 inhibitor that is     applied orally. The purpose of the present trial is to investigate the erbB family inhibition     by afatinib in patients with metastatic pancreatic cancer.      In the planned trial, afatinib will be applied at the dose (40 mg/day) that was chosen for     the randomised phase III trial (LUX 5 study) that investigates afatinib plus weekly     paclitaxel (80mg/m2).      Presently there is also a phase I study ongoing that investigates the combination of afatinib     with gemcitabine (ClinicalTrials.gov Identifier: NCT01251653 U10-2249-02 ). Possibly the data     will be available once the study is ready to start. Otherwise a modification of the regimen     will be planned once the respective data will be available.      In this trial, we integrate a translational project which may allow the identification of     patients that primarily benefit from this novel treatment approach. The availability of     tumour tissue- and blood samples from each patient is therefore an important inclusion     criterion.      A 2:1 randomisation is chosen favouring the experimental arm since a large body of data is     available on gemcitabine alone and since sufficient efficacy and toxicity data shall be     gained in the experimental arm. In addition, the patients' motivation to take part in the     trial will be greatly enhanced by a greater chance to receive the experimental agent.   "
118962|NCT01728805|"     The purpose of this study is to compare the progression free survival of KW-0761 versus     vorinostat for subjects with relapsed or refractory CTCL.   "
118963|NCT01728792|"     This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine     Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous     (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector     (PharmaJet Stratis™).   "
118964|NCT01728779|"     Patients with metastatic lesions of the lung, liver, or bone will be candidates for     treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion     site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral     therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same     Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.   "
118965|NCT01728766|"     Data collected from this study will provide information on the breast milk zinc     concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk     to infants during first six months of life.   "
118966|NCT01728753|"     This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age     diagnosed with uncomplicated influenza.   "
118967|NCT01728740|"     To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose     combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).   "
118987|NCT01728480|"     This phase I trial studies the side effects and best dose of entolimod in treating patients     with stage III-IV or recurrent head and neck cancer. Biological therapies, such as entolimod,     may stimulate the immune system in different ways and stop tumor cells from growing.     Entolimod may also prevent side effects caused by chemotherapy with cisplatin and radiation     therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in     chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving entolimod together with     cisplatin and radiation therapy may kill more tumor cells   "
118993|NCT01728402|"     The cause of blood and bone marrow cancers is poorly understood; however, most research     focuses on how cancer cells grow and develop. Because the causes of these cancers are     unknown, current treatments may be unnecessarily harsh and often do not provide a cure.     Identifying the causes of blood cancers would allow for the development of treatments that     are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we     will look for specific cancer cell abnormalities that are responsible for cancer cell growth.     We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.   "
118968|NCT01728727|"     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related     hepatitis can developed into liver cirrhosis.      Liver transplantation is the only available life saving treatment for patients with end stage     liver disease. However, lack of donors, surgical complications, rejection, and high cost are     serious problems.      Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into     hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical     cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater     overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived     from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose     homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver     cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety     and efficacy of hUC-MSC treatment for these patients.   "
118970|NCT01728701|"     The purpose of the study is to determine the safety and tolerability of ID administration of     PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called     PfSPZ-CVac).   "
118971|NCT01728688|"     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related     hepatitis can developed into liver cirrhosis.      Liver transplantation is the only available life saving treatment for patients with end stage     liver disease. However, lack of donors, surgical complications, rejection, and high cost are     serious problems.      In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from     patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and     autologous PBSC transplantation can significantly improve liver synthetic function. But     further studied was needed to confirm the safety and efficacy of PBSC transplantation. In     this study, a prospective, randomized, parallel clinical study was designed. The patients     with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via     hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for     these patients.   "
118972|NCT01728675|"     The purpose of the present investigation is to compare the responses and adaptations of young     and elderly individuals to repeated eccentric exercise in regards to muscle function and     redox homeostasis in a side-by-side comparison.   "
118973|NCT01728662|"     This study will test that hypothesis that endoscopic lung volume reduction therapy performed     using emphysematous lung sealant treatment can be improved using smaller doses delivered to     more a larger number of treatment sites.   "
118974|NCT01728649|"     The purpose of this study is to determine whether reducing a patients body temperature (mild     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury     (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a     significant interruption of blood flow to an area of brain (occlusion of large proximal     cerebral artery) and have undergone successful removal of that interruption     (revascularization).This will be achieved by comparing patients that have undergone     hypothermia to those that have not.   "
118975|NCT01728636|"     The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss     and red blood cell transfusion during high risk spine surgery.   "
118976|NCT01728623|"     This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally     administered once daily (QD) in subjects with advanced thyroid cancer.   "
118977|NCT01728610|"     The purpose of this study is to analyse the effect of a probiotic supplement on functional     intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).   "
118978|NCT01728597|"     One of the main problems in cardiac magnetic resonance (MR) investigations is the strong     dependence of the achieved image quality on optimal settings of sequence parameters and     anatomical and physiological situations and it is well known that the diagnostic impact of     cardiac MR investigations crucially depends on the adaption of imaging protocols to patients'     state and ability to cooperate.      The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3     Tesla cardiac MR investigation protocols without application of contrast agent as well as the     acquisition of normal values for new cardiac MR images techniques:        -  normal myocardial morphology: T1-, T2- and T2*-weighted imaging and acquisition of          normal values of magnetic relaxation times (sequence- and protocol dependent),        -  normal cardiac function: systolic and diastolic function (sequence- and protocol          dependent),        -  coronary artery imaging: feasibility to evaluate length, diameter and blood flow          (sequence- and protocol dependent),        -  normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D          blood flow imaging and evaluation techniques (sequence- and protocol dependent).   "
118979|NCT01728584|"     The purpose of this pilot study is to compare the use of deep or standard neuromuscular     blockade (NMB) in combination with low or standard insufflation pressure in participants     undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the     injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow     visualization of and access to the surgical field. The primary hypothesis of the study is     that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical     conditions as compared to standard NMB. The in-patient surgery is performed on Day 1 and the     participant remains hospitalized for at least 48 hours following the surgery (or at least 24     hours following the surgery, if local practice does not allow 48 hours of hospitalization     post surgery). On Day 8, a follow-up visit/contact including all participants occurs.   "
118980|NCT01728571|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses.      This ancillary study is being conducted among participants in VITAL and will examine whether     vitamin D or fish oil improves respiratory symptoms or reduces the risk of lung infections or     reduces the decline of pulmonary function.   "
118994|NCT01728389|"     The purpose of the study is to evaluate efficacy and safety of direct intrabone     transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched     sibling donors in patients with myeloid and lymphoid malignancies.   "
118981|NCT01728558|"     The Use of sedative drugs in intensive care is widespread. A cohort study conducted in     Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the     first 48 hours of mechanical ventilation which was independently linked to prolonged     ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of     lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009)     supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens     ventilation time and attenuates delirium when compared to midazolam and propofol.      The investigators confirmed in a pilot study the feasibility, efficacy and safety of a     process of care known as Early Goal Directed Sedation (EGDS) that delivers:        1. Early randomization after intubation or arrival in the ICU (intubated).        2. Early Adequate analgesia after randomization.        3. Goal directed sedation titrated to achieve light sedation.        4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of          benzodiazepines.      The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when     compared to standard care sedation in critically ill patients.      The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care     sedation, reduces 90-day all-cause mortality in critically ill patients who require     mechanical ventilation.   "
118982|NCT01728545|"     The goal of this study is to collect blood samples from the umbilical cords of newborn     babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord     Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which is     part of the CW Bill Young Cell Transplantation Program. The NCBI is a federally-supported     program to assist in the collection of cord blood. Cord blood will be made available to     patients through The National Marrow Donor Program (NMDP). These samples may then be offered     to MD Anderson and other institutions for patients who need a bone marrow transplant and do     not have a donor. The MD Anderson Cord Blood Bank will have the rights to release cord blood     units to these institutions around the world according to established bone marrow transplant     donor criteria, for a fee to cover costs.      Cord blood samples that are collected and then do not meet the clinical requirements for     patient use may also be used at MD Anderson or other institutions either for research or for     quality purposes to improve cord blood banking procedures. If not suitable for patient use or     for research purposes, the cord blood unit may be thrown away.   "
118983|NCT01728532|"     TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical     tolerance of PA0903 as root canal sealer      SPONSOR:      SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33     1-49-76-74-26, Fax. : + 33 1- 49-76-71-91      Reference protocol: 11/001      PRODUCT NAME: PA0903      MEDICAL DEVICE:      Class III: Root canal sealer Dose: not applicable Application : one single time      DEVELOPMENTAL PHASE: not applicable (medical device class III)   "
118984|NCT01728519|"     Birch pollen allergic patients are currently treated by subcutaneous injections of pollen     extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush     immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital     environment due to the risk of potential anaphylactic reactions. The aim of this study is to     test the new product AllerT expected to show widely reduced side effects. AllerT will be     injected via two different routes, subcutaneous versus intradermal. The primary endpoint of     the study is the local and systemic safety of repeated injections of the product. Since     AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic     symptoms, we will also evaluate the potential efficacy of the approach using a nasal     provocation test (NPT) with birch pollen   "
118985|NCT01728506|"     The purpose of this study is to test the effectiveness of a behavioral weight loss and     exercise intervention delivered via the internet at different cancer centers in New England.     The investigators hypothesize that participants will lose 7% of their body weight. The     research is being done because many women who are treated for breast cancer are overweight     and treatment for breast cancer is often accompanied by weight gain. Individuals who are     overweight may be more likely to have their breast cancer come back. Also women who exercise     at least three hours a week seem to have less chance of their cancer coming back. The     investigators hope to identify an effective weight loss and exercise intervention for breast     cancer survivors that can be easily accessed by many people.      This study is designed to determine the feasibility of conducting a distantly     delivered-weight loss and exercise intervention for patients who have been treated for breast     cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral     weight loss and exercise intervention delivered to overweight/obese breast cancer survivors     in three New England locations.      Participants will be recruited from three New England Cancer Centers - the Vermont Cancer     Center, Norris Cotton Cancer Center at Dartmouth University and the University of     Massachusetts Cancer Center. Participants from each center will undergo baseline assessments     that include diet assessment, body measurements (height, weight, etc), a physical activity     assessment and be asked to complete a series of questionnaires.      Patients that meet the minimum requirements will be enrolled on the study. They will     participate in weekly on-line chats about behavioral and diet modifications led by a     qualified facilitator. Participants will also engage in increasing amounts of aerobic     activity (typically walking) throughout the course of the intervention. The intervention     lasts 6 months. At the end of those 6 months, participants will have the same assessments     that were collected at baseline. Following the collection of those assessments, participants     will have completed the study.   "
118986|NCT01728493|"     Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused     by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99%     predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal     hyperplasia (BAH). Diagnosis of PA is relevant for two reasons:        1. independent of the level of blood pressure, hypertension due to autonomous aldosterone          secretion causes more cardiovascular damage than essential hypertension;        2. PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid          receptor antagonists (MRA) in case of BAH.      Although previously presumed a rare condition (prevalence <1%), PA is now estimated to affect     6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as the     amount of cardiovascular damage and the available specific treatment, the question is raised     whether screening of PA should be introduced in Dutch general practice. To answer this     important question, several issues with regard to PA need to be elucidated:        1. International studies report a prevalence of PA in general practice of 6-13%. Prevalence          in the Dutch population is still unknown;        2. Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of          hypertension (mean eight years), data on characteristics of early diagnosed PA are          lacking. Proof of early cardiovascular damage would strengthen the case of screening for          PA and needs to be studied;        3. Consequently, the diagnostic delay has lead to lack of data on optimal treatment in          early PA. In the current guideline (NHG-guideline 'Cardiovascular risk management') a          regimen of antihypertensive drugs is advised, and only if hypertension is refractory for          >6 months patients are referred. It is unknown if hypertension is resistant to therapy          in the initial phase of PA. If not, this would also argue for early biochemical          screening for PA, because even if blood pressure is controlled, the detrimental effect          of aldosterone itself will go on unopposed. It is therefore required to study the          response to antihypertensive drugs (not MRA) in these patients.   "
118988|NCT01728467|"     This study builds on data that high-density lipoprotein (HDL) has a number of potentially     beneficial effects including directly modulating glucose metabolism through multiple     mechanisms. The primary objective of this study is to determine the effects of RVX000222 on     postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or     impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test     (OGTT).   "
119002|NCT01728285|"     Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic     diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment     of allergic rhinitis, which has to be taken daily by patients. This study was aimed to     establish if a device with the characteristics of a mechanical dispenser (Memozax®) could     improve adherence to treatment in subjects with hay fever due to allergy to grass   "
119003|NCT01728272|"     Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the     absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump     surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.   "
119004|NCT01728259|"     This phase I trial studies the side effects and best dose of pomalidomide and bortezomib when     given together with dexamethasone in treating patients with amyloid light-chain amyloidosis     or light chain deposition disease. Biological therapies, such as pomalidomide, may stimulate     the immune system in different ways and stop abnormal cells from growing. Bortezomib may stop     the growth of abnormal cells by blocking some of the enzymes needed for cell growth. Giving     pomalidomide and bortezomib together with dexamethasone may be an effective treatment for     amyloid light-chain amyloidosis or light chain deposition disease   "
119005|NCT01728246|"     The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life     (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to     another medication) in Filipino participants with chronic (lasting a long time)     osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become     painful and stiff).   "
119006|NCT01728233|"     Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily     on regional lymph-node involvement. Despite the fact that cure can be obtained in patients     with low metastatic load (pN1) by monotherapy, combination therapy is required for more     advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not     very effective so far and the few chances for cure are solely dependent on multimodality     treatment, either with surgery or radiation. Based on the observation that the epidermal     growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming     similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been     investigated with promising early results at Istituto Tumori Milan and University of Texas MD     Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor     dacomitinib for advanced or metastatic penile SCC.   "
119007|NCT01728220|"     This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming     clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination     product, inhaled nitric oxide/INOpulse DS-C vs. placebo in subjects with World Health     Organization (WHO) Group 3 pulmonary hypertension (PH) associated with Chronic Obstructive     Pulmonary Disease (COPD) on Long Term Oxygen Therapy (LTOT).   "
119008|NCT01728207|"     IMMU-114 will be studied at different dose schedules and dose levels in order to assess the     highest dose safely tolerated. IMMU-114 will be administered subcutaneously (under the skin).     IMMU-114 will be given 1-2 times weekly for 3 weeks followed by one week of rest. This is     considered one cycle. Treatment cycles will be repeated until toxicity or worsening of     disease.   "
119009|NCT01728194|"     This study may help identify how abnormalities in brain systems that control the ability to     ignore irrelevant information may contribute to the development of depression in older     adults.   "
119037|NCT01727830|"     Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution     with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate     reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination     of FBG and FXIII.      In blood of 12 volunteers the following measurements are performed at baseline and 60%     dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation     factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational     thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in     concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and     determination of factor concentrations are again performed.        -  Trial with medical device   "
119010|NCT01728181|"     The current trial A Phase I/II study of Erlotinib +/- Tivozanib as initial treatment for     Metastatic Non-small Cell Lung Cancer assigned by VeriStrat® Serum Proteomic Evaluation will     begin by evaluating toxicity for the combination of Tivozanib and Erlotinib to determine a     phase II dose. The phase II portion of the study will seek to duplicate the finding of the     BEER trial in a selected population of patients with NSCLC with a VeriStrat® Good signature     using two oral agents with Tivozanib substituted for bevacizumab. Phase II will be designed     as a selection-based randomized trial. Patients with VeriStrat® Good signature will be     assigned to EGFR inhibitor therapy with a randomization to Erlotinib plus/minus Tivozanib.     Patients with VeriStrat® Poor signature will be assigned to standard of care.     Standard-of-care chemotherapy as first treatment at the discretion of patient and physician     will be evaluated for response to treatment, survival and repeat VeriStrat® signature.   "
119011|NCT01728168|"     The objective of the study is to assess the prevalence of a sensitization to proteins from     legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material     (lupin) in atopic and healthy subjects.   "
119012|NCT01728155|"     The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study),     groups together in a single protocol the treatment of all patients with non high risk     neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk.     These two separate cohorts are included in one single protocol to enable patient data from     these two groups to be entered into a common database, as the current prognostic     classifications determining treatment may evolve further with subsequent more detailed     molecular analysis of the tumours.      1. LOW RISK STUDY      The Low Risk Study is proposed in order to:        -  minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk          patients, who in previous studies have been shown to have an excellent long-term outcome          (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was          greater than 97%(H. Rubie, JCO).        -  improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a          SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental          chromosomal change (SCA)) by electively treating these patients with chemotherapy          despite the absence of symptoms.           2) INTERMEDIATE RISK STUDY      The Intermediate Risk Study is proposed in order to:        -  reduce the amount of chemotherapy for differentiating histology INRG (International          Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in          previous SIOPEN study have been shown to have an excellent long-term outcome;        -  increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for          poorly differentiated or undifferentiated histology INRG stage L2 NB or          ganglioneuroblastoma nodular patients in order to improve the EFS registered in the          previous SIOPEN study;        -  improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related          oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB          patients with the introduction of adjuvant treatment;        -  maintain the very good results obtained in previous SIOPEN study for INRG stage M          infants with a moderate treatment.      NEONATAL SUPRARENAL MASSES      The incidence of suprarenal tumours/masses has increased in the last decade due to the     expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and     early infancy care. The differential diagnosis of these masses ranges from benign (adrenal     haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on     perinatal suprarenal masses, although based on a relatively large literature, is scattered     amongst studies on very few cases with no methodical approach and often short follow up.     Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma     at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN     Group, based on their results in the first multicenter European Trial for infants with     neuroblastoma (INES) and the world-wide experience provided in the literature, is launching     this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for     these masses. Treatment: Observation   "
119013|NCT01728142|"     The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable,     portable, and field-hardened NeuroCognitive Assessment Tool. The purpose of this study is     to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological     Assessment Metrics (ANAM) battery currently used by the military after concussion. The     primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued     impaired cognitive performance than the ANAM during recovery after a concussion.   "
119014|NCT01728129|"     The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE     cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive     for detecting impaired cognitive performance than the MACE cognitive score in the setting of     a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary     purpose of this study is to examine a serial performance on the DANA Rapid exam in those     subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam     will show improvements in performance during the recovery period after concussion.   "
119017|NCT01728090|"     The aim of the study was to assess the effectiveness of a hand-washing programme using hand     sanitizer in the prevention of school absenteeism due to upper respiratory infections.     Students in intervention classrooms used hand sanitizers at schools and a programme     educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in     elementary school will reduce absenteeism due to upper respiratory infections.   "
119018|NCT01728077|"     N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of     Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life     and to explore the direct medical resource use for BRV (for subjects entering N01372 from a     study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of     200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.   "
119019|NCT01728064|"     The purpose of this study is to examine the effects of EPI-743 on visual function and     neurologic function in patients with Friedreich's ataxia.   "
119020|NCT01728051|"     The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted     in the same patient population as well as using the same melphalan dosing as proposed in this     study. This expanded access protocol will provide an experimental alternative treatment     option for both physicians and patients until the Delcath CS-PHP System receives marketing     approval.   "
119022|NCT01728025|"     The purpose of this study is to determine whether ranolazine will reduce the risk of     arrhythmic events in patients with long QT syndrome type 3.   "
119023|NCT01728012|"     Mineral metabolism disturbances occur early during the course of chronic kidney disease and     eventually affect most patients. For how long such disturbances persist after a successful     renal transplantation is mainly unknown. This study will investigate the prevalence of such     disturbances in patients more than 10 years following a successful renal transplantation. The     patients will be recruited from an existing registry in Norway.   "
119038|NCT01727817|"     An unblinded, randomized, cross-over design with each patient participating in two 40-hour     outpatient admissions: (a) Experimental involving automated Control to Range (CTR) and (b)     Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a     hospital based clinical research center.   "
119039|NCT01727804|"     The aim of this controlled clinical study was to evaluate the Nd:YAG laser, with or without     fluoride, in prevention of occlusal caries in the primary dentition.   "
119191|NCT01725789|"     This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic     anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective     measures (Hb and iron parameters).      Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.   "
119024|NCT01727999|"     Introduction:      Ineffective platelet production has been proven to play a role in the etiology of Immune     Thrombocytopenia (ITP) in addition to increased platelet destruction. The second-generation     thrombopoietin (TPO) mimetics have shown good efficacy in boosting platelet counts in the     great majority of patients with chronic ITP in several clinical trials.1, 2 Nevertheless,     about 20% of patients with ITP fail to respond to the TPO mimetic treatment. Those     treatment-resistant patients are un-characterized and the reasons for the lack of response     have not been studied. The identification of predictive blood biomarkers of patients'     response to treatment will be useful in reducing both cost and potential side effects; and it     will be of equal importance and interest to investigate the molecular mechanisms underlying     the patients' heterogeneous responses to TPO mimetic treatment.      Specific Aims:        1. To identify blood classifier genes which correlate with patients' response to TPO          mimetic treatment.        2. To compare the blood gene expression changes in responders and non-responders after TPO          mimetic treatment and explore the possible molecular mechanisms accounting for the          non-responsiveness to the treatment.   "
119025|NCT01727986|"     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who     completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical     response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra     8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.   "
119026|NCT01727973|"     The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50     mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy     (GO).   "
119027|NCT01727960|"     Neck and shoulder pain (NSP) is fairly common among high school students in Korea.     Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an     inappropriate static position for a prolonged period of time. We suspect that proper     education and posture correction for Korean adolescents may decrease the prevalence or     severity of NSP. Although several studies have focused on the etiology of NSP during     adolescence, few studies have addressed the management or prevention of NSP in adolescents,     despite its high prevalence in this age group. The aims of this prospective study was to     identify the effects of education, in terms of recognition of this issue and posture     correction, on prevalence and severity of NSP in Korean adolescents   "
119028|NCT01727947|"     Current research on sperm morphology has been directed towards the dysmorphisms of the sperm     head. A new technique based on the motile sperm organelle morphology examination (MSOME)     allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are     specific sperm alterations observed under high magnification, and their presence has been     related to increased DNA fragmentation and denaturation.   "
119029|NCT01727934|"     The purpose of this open-label study is to assess the safety, antiviral activity, and     pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over     5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12     weeks of treatment. The subjects enrolled in this study are chronically infected with HCV     genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.   "
119170|NCT01726062|"     A randomized, controlled, parallel group design will be used to test whether a Secondhand     Smoke Exposure program initiated in the hospital and completed in the home using motivational     interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC)     with Neonatal Incentives Care Unit Infants' parents.   "
119030|NCT01727921|"     Background:      EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with     pancreatic mass with high specificity, specificity and accuracy. However FNA with small     needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this     limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore     needles were frequently used. However there was no comparative study of the efficacy and     accuracy between 22 and 25 gauge ProCore needle yet.      Aim:      To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore     needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not     inferior to 22 gauge ProCore needle.)   "
119031|NCT01727908|"     The purpose of this study is to determine whether staining of the gastric mucosa increases     the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in     first degree relatives of individuals with familial gastric cancer.   "
119032|NCT01727895|"     The purpose of this study is to test wether orally administered Beta-glucan has systemic     effects in humans.   "
119033|NCT01727882|"     The purpose of this study is to investigate whether automated telephony may be used for daily     assessments of paroled offenders, and whether a brief intervention based on these daily     assessments may result in a more positive development compared to daily assessments only.   "
119034|NCT01727869|"     This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in     combination with erlotinib or cetuximab administered to patients with certain types of     cancer.   "
119035|NCT01727856|"     Rehabilitation exercise conducted at home following injury improves clinical and functional     outcomes. Optimum compliance with prescribed exercise regimens requires regular patient     instruction, performance assessment, monitoring and general encouragement from healthcare     staff. Exercise at home though convenient for patients is not conducive for provision of the     professional support needed to maximize prescribed regimen effectiveness.      Software in development by Reflexion Health Inc. along with the Naval Medical Center San     Diego (NMCSD) is being designed to facilitate remote staff-patient interaction during at-home     rehabilitative exercise sessions. Microsoft Kinect® will serve as the hardware platform for     the designed software package tentatively called, Reflexion. Kinect® contains a     marker-less/controller-less motion tracking camera. The final Reflexion software will rely on     a Rehabilitation Measurement Tool (RMT) to detect cardinal plane skeletal joint movement     and its velocity utilizing the embedded Kinect® camera while also providing patient visual     feedback via an avatar on a television screen.      In this observational minimal risk study, RMT/Kinect® functional reliability and usability     will be assessed. Twenty healthy subjects will physically set-up and turn-on the     hardware/software system; receive exercise directions from the RMT; then conduct a series of     knee exercises similar to those prescribed after anterior cruciate ligament (ACL) repair.      An initial limited data set, obtained by Reflexion Health, provided validity and reliability     measures. Eighteen degrees of absolute difference was detected between manual goniometry and     Kinect® measurements in relevant planes of movement utilized during prescribed ACL exercise.     Good relative agreement between RMT and goniometry scores was obtained (ICC = 0.89). A     correctable systematic bias toward underestimation by the RMT will allow for future more     accurate estimations of joint positioning improving face validity.      RMT functional reliability and general usability will be expressed in this study utilizing     descriptive statistics and scaled questionnaires. Hardware component malfunction (Kinect®     camera, laptop, PC, or LCD television/monitor) as well as RMT internally logged software     errors and failure will tallied and measured to ascertain RMT reliability.      User-RMT interaction quality will be evaluated with video recordings of each set-up and     exercise session. Specifically, usability measures will include: need for additional     assistance setting-up or operating the RMT; number of attempts required by the subject to     interact with a specific feature: time spent on specific elements during the session.     Participant feedback will be elicited post-session using two scaled questionnaires: System     Usability Scale (SUS)and Reflexion Usability Scale (RUS). Findings from the study will guide     software modifications needed prior to implementation of future clinical studies within the     NMCSD population.   "
119036|NCT01727843|"     Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin     and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies     and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However,     concerns about the prothrombotic side effects of systemic administration of TA has hindered     the widespread adoption of this medication in orthopaedic patients due to their high risk for     thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical     application of tranexamic acid has been proposed as a way to mitigate the potential     prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial     in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following     topical application, minimizing its potential systemic thromboembolic side effects. TA has     been used topically in total knee arthroplasty, with significant reductions in blood loss and     no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture     surgery is limited, and there are no studies examining topical use of TA in hip fracture     surgery. Our study question is: Does topical tranexamic acid decrease blood loss following     hemiarthroplasty of the hip for femoral neck fractures?   "
119040|NCT01727791|"     This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in     healthy lactating women. The objectives are to determine whether pregabalin is secreted in     breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other     objectives are to estimate potential infant exposure to pregabalin if administered to     lactating women and to characterize the safety and tolerability of pregabalin in lactating     women.   "
119041|NCT01727778|"     Primary      - To evaluate the safety and tolerability of escalating doses of an intravenous (i.v.)     infusion of PAT-SM6 in subjects with relapsed or refractory multiple myeloma.      Secondary        -  To evaluate the efficacy and pharmacodynamics by analysis of serum and urine M protein,          serum free light chains (FLC) κFLC and λFLC, total immunoglobulins, β2-microglobulin,          C-reactive protein (CRP), exploratory biomarkers and anti-PAT-SM6 antibodies.        -  To evaluate the duration of response and the progression free survival.   "
119042|NCT01727765|"     This is a pilot study which will assess the feasibility of a follow on main study. This study     will examine the impact of inspiratory muscle training on quality of life, rescue drug     medication usage, and other markers of asthma in adult asthmatics in the UK.   "
119043|NCT01727752|"     A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous     Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication     caused by Lumbar Stenosis   "
119044|NCT01727739|"     Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings     autograft may contribute to failure of the graft and/or present technical challenges     secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be     made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing     the biomechanical properties of the graft construct. The purpose of this investigation is to     examine the tibial tunnel widening relationship between bioabsorbable interference screws     composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws     composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as     tibial fixation devices.      Specifically the study has the following objectives: 1) To quantify the extent of tibial     tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled     hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the     bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To     hypothesize mechanisms for any observed differences between tibial fixation devices; and 4)     To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the     PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial     tunnel widening around the implant but rather between the implant and articular surface,     compared to the PLLA alone screw. It is also hypothesized that there will be no effect of     observed tunnel widening on clinical outcomes or graft failure rates.   "
119045|NCT01727726|"     To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy     to an assigned open label antidepressant therapy (ADT) in the proposed subject population     with MDD.   "
119046|NCT01727713|"     The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing     Total Tic Severity in children and adolescents with Tourette's Disorder.   "
119047|NCT01727700|"     The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole     in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.   "
123230|NCT01672996|"     To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To     evaluate the safety and tolerability of low concentration Ioforminol Injections. Study     recruits healthy volunteers.   "
119048|NCT01727687|"     As society ages, a large amount of human factors related research has been carried out into     the subject of the safety of the elderly in their daily lives. However, most research focuses     on the general elderly population and there is a serious lack of research into elderly     sufferers of Parkinson's disease (PD), who receive a substantial amount of attention in     medical circles. In the investigators previous study, the investigators have found that     patient with PD had decreased ability to cross the road as compared to age/gender matched     control subjects. Hence, this research proposed several training programs to enhance the     safety of crossing road, including safe place finding，roadside search，time gap and perception     of other's intentions. The investigators will compare the parameters of crossing road ability     before and after training programs in patients with PD and control subjects.      The results of this research will clarify the correlation between medical scale test     indicators and movement safety for patients with PD. The effects of training programs will be     provided for further safety management and design concepts to improve the lives of this     disease group.   "
119049|NCT01727674|"     According to the statistics released by the Department of Health,Executive Yuan in     2005,depression, cancer and AIDS will become the three main diseases of the 21st century.The     prevalence of depression is 5.8% for males and 9.5% for women in the worldwide total     population each year.Depression ranks second next to cardiovascular disease and impacts on     social and economic burdens.From the perspectives of prevalence,suicide rate,loss of     workforce,family burden,co-morbidities and health care expenses,the issues related to caring     for patients with depression should not be overlooked.Communication is often neglected while     exploring the issues of caring for depressed patients,which can consequently affect their     family,work performance,social interaction,and even leads to a risk of suicide.Therefore,in     order to enhance their psychological adjustment and health management,it is particularly     important to achieve effective communications.   "
119050|NCT01727661|"     The purpose of this study is to compare the differences of        1. cardiopulmonary fitness        2. lung function        3. muscular oxygen saturation        4. quality of life between type 1 diabetes mellitus and healthy adults.   "
119051|NCT01727648|"     The findings of this project will contribute to the understanding of a comprehensive probe     for investigation of the effects of monotherapy versus combination rehabilitation     intervention after stroke, including the topics of possible underlying mechanisms of motor     recovery as well as the beneficial and adverse effects of intense rehabilitation therapy,     prognostic factors of the outcomes, and clinimetric properties of the instruments. The     overall findings of this project will be significant in the era of knowledge translation and     guide the development of innovative and effective interventions for individualized stroke     rehabilitation.   "
119059|NCT01727544|"     The primary objective of this study is to measure objective, functional outcomes of patients     undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.   "
119060|NCT01727531|"     This research is being done to determine if a short course of Chloroquine (five weeks)     before, during and after whole brain radiation therapy (WBRT) will improve the overall     survival of subjects being treated for brain metastases.   "
119061|NCT01727518|"     The Austrian LEAD study is the first investigation initiated in Austria that aims to     investigate the prevalence and the natural history of COPD in a reference population of     Austria.   "
119052|NCT01727635|"     Aims and objectives: This study aims to examine the effects of the body-mind-spirit group     therapy on marital close relationships, sleeping quality, depression, quality of life,     meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and     partners.      Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast     cancer survivors will be recruited from outpatient department of surgical at hospital. The     partners will be invited to participate in this study through the survivors. The 120 dyad     survivors and spouse will be randomly assigned into an experimental group or a control group.     Survivors and spouse partners in an experimental group will receive 2 months time     body-mind-spirit group therapy while those in a control will receive usual care in the same     period of time. The outcome measures include Experiences in close relationships scale, Moss     sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life     questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points     include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12     months after the end of intervention for the maintenance effect. Univariate analyses will be     performed to explore the basic characteristics of participants. The hierarchical linear model     will be used to test the hypothesis the improvement is higher in intervention group than the     control group in the effects of marital close relationships, sleeping quality, depression,     meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer     survivors and partners.   "
119053|NCT01727622|"     The purpose of this study is to determine the value of Arterial Spin Labeling (ASL) MRI, a     measure of blood flow to the brain, in Mild Cognitive Impairment (MCI) and compare it to     existing measures. In particular, the investigators will compare ASL MRI to Positron Emission     Tomography (PET/CT), which measures brain metabolism reflecting how well cells in a patient's     brain are functioning. In addition, the investigators will assess the relationship of these     measures to specific protein levels associated with Alzheimer's Disease in the patient's     cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) obtained by lumbar     puncture. By comparing the information that is available from these procedures to the     patient's performance on cognitive tests, the investigators hope to learn which procedures     most accurately reflect and assist in determination of the potential causes of cognitive     difficulties that arise with MCI, and thus, which are most useful in the clinical setting. In     particular, PET scans have been found to be very useful in diagnosis of MCI and Alzheimer's     Disease, but the investigators want to find out if they can get the same, or better,     information from an ASL MRI scan, which is less expensive and easier to acquire.   "
119171|NCT01726049|"     Aim of the study is to investigate whether Sildenafil treatment results in a reduction of     pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of     exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF)     with pulmonary hypertension ( PH).   "
119172|NCT01726036|"     The purpose of this study is to compare two commonly used circumcision clamps (Gomco and     Mogen) to see which results in less neonatal pain.   "
119054|NCT01727609|"     Survival of preterm infants has increased greatly over the years, so a major aim now is to     improve the long term outlook for these babies and to avoid serious complications. The way     babies are fed in early life affects short and long-term health and survival.      Because the bowels of preterm infants have not matured, they cannot digest large volumes of     milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip     while the amount of milk given is gradually increased over time. Increasing the amount of     milk rapidly may increase the risk of gut complications. Increasing the amount of milk given     more slowly means that intravenous nutrition is needed for longer; there is an associated     risk of infection proportional to the time the intravenous line is present in the bloodstream     of these infants. Despite the importance of milk feeding preterm infants, there have been few     studies to inform how best to balance these risks, and what the best way to increase feeds in     these infants is - this study sets out to address this missing information.      The study will compare two different speeds of milk feed increase, one 'faster' and one     'slower', both within rates currently used in United Kingdom neonatal units. The study aims     to find out if either speed of milk feed increase gives better outcomes for the infants.     Investigators will measure a variety of outcomes, such as survival without disability,     infection, bowel problems, growth and long-term physical and mental development, as well as     the impact on families and the National Health Service, including costs.      The study is being led by an established team of researchers who have run similar studies     before, and uses an established network of neonatal units that have taken part in previous     studies.   "
119055|NCT01727596|"     Background: Taping has been used for more than 20 years for patellofemoral pain syndrome     (PFPS) but the effectiveness is still controversial.      Purpose: This prospective study was conducted to investigate the effect and predictors of     effectiveness of taping in treating PFPS.      Study design: Prospective cohort study Methods: One hundred consecutive patients with the     diagnosis of PFPS were included in the study. Factors including sex, age, body mass index     (BMI), Q angle, lateral patella displacement (LPD), lateral patellofemoral angle (LPA) and     pre-taping pain score were measured. One well-trained therapist applied adhesive tape to each     patient by McConnell approach. Before and after taping, patients completed a visual analog     pain scale (VAS) after performing a step-down from an 8-inch platform. Paired-t test was used     for the difference of the VAS score measured before and after taping. Patients with     improvement of more than 1 point in VAS score after taping were considered responsible, and     others were non-responsible. The results were analyzed by logistic regression.   "
119056|NCT01727583|"     This pilot study is aimed at assessing the acute effect of several combinations of lipids     differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1     secretion in healthy subjects.   "
119057|NCT01727570|"     To determine the impact of nutritional supplementation with whey protein on postoperative     functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized     that, compared with a control group receiving nutrition counselling only, patients receiving     nutritional counselling along with preoperative and postoperative nutritional supplements     will have a significantly improved change in functional walking capacity from baseline to 8     weeks after surgery.   "
119058|NCT01727557|"     This study is being done to compare the two anesthesia techniques which are commonly used in     the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local     anesthesia means that, your doctor will inject numbing medication directly into the tissue or     part of your body where the surgery will be done. In this case, the numbing medication will     be injected directly into the area where your fistula will be made. In regional anesthesia,     the numbing medication will be injected around the nerve (part of the body that gives     sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare     the three month success rates of AV fistulae created by the two anesthesia techniques.   "
119062|NCT01727505|"     Preterm infants undergoing mechanical ventilation often present with respiratory instability     which leads to fluctuations in ventilation and oxygenation. In conventional modes of     mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate     and a constant peak inspiratory pressure.      We have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated     preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by     decrease in tidal volume. This is due to a reduction in respiratory system compliance and     increase in airway resistance.      Volume Guarantee ventilation is a mode of ventilation in which ventilator measures the     exhaled tidal volume of each ventilator breath and automatically adjusts the peak inspiratory     pressure to deliver the set tidal volume. We have previously shown that Volume Guarantee     reduced the severity and duration of hypoxemia episodes during a period of 2 hours in preterm     infants The study hypothesis is that Volume Guarantee ventilation will decrease the duration     of episodes of hypoxemia when compared to conventional mechanical ventilation during routine     clinical conditions and over longer periods of time.      The objective of the study is to evaluate the effects of Volume Guarantee on the duration,     severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants     who present with frequent hypoxemia episodes in comparison to conventional ventilation over     two periods of 24 hours each and under routine clinical conditions.   "
119063|NCT01727492|"     The current study is a dubble-blinde placebo-controlled cross-over study verifying the     preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced     tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which     should be taken 1h before leisure noise above 100dB for at least 30 minutes.   "
119064|NCT01727479|"     Investigate the acute effect of ribose supplementation on performance and recovery in     athletes.   "
119065|NCT01727466|"     Children with high-functioning autism spectrum disorders (ASD) are at high risk for     developing significant anxiety symptoms. Cognitive behavior therapies (CBT) are frequently     used for children with anxiety symptoms with good success. The purpose of the current study     was to examine the efficacy of a family-focused group CBT program (Facing Your Fears [FYF])     compared to Treatment As Usual (TAU). Participants were randomized to either active treatment     or TAU. It was hypothesized that children who completed the active treatment would     demonstrate improvement in their anxiety symptoms relative to children in TAU.   "
144394|NCT01394406|"     Ketamine added to intravenous patient-controlled analgesia may be effective on prevention of     postoperative nausea and vomiting by reducing opioid requirement after surgery.   "
119066|NCT01727453|"     SUMMARY      1.0. Type of Application: Clinical trial comparing two treatments in terms of authorized use.      1.1. Promoter: Institute of Research, Hospital de la Santa Creu i Sant Pau. Avgda. Sant     Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140/93 291 21 73.      1.2. Title: Randomized controlled trial to compare treatment with oral anticoagulation with     antagonists of vitamin K versus low molecular weight heparin (Bemiparin) in patients with     anticoagulation criteria and who have had an episode of gastrointestinal bleeding.      1.3. Protocol code: HEPACO 1.4. Principal Investigators: Dr. Candid Villanueva Sanchez. Dr.     Jose Mateo Arranz. Contributors: Dr. Alicia Brotons (Service of Digestive Pathology), Dr.     Angela Puente (service of Digestive Pathology), Dr. Isabel Graupera (Service of Digestive     Pathology) and Dr. Marina Carrasco (Hematology Service). Hospital de la Santa Creu i Sant     Pau. Avgda. Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: (34) 93 291 91 39. Fax: (34)     93 291 92 78.      E-mail: cvillanueva@santpau.es. 1.5. Centers that are planned for the trial: Service     Gastroenterology and Hematology Service of the Sant Creu i Sant Pau, Barcelona.      1.6. Clinical Research Ethics Committee: Hospital de la Santa Creu i Sant Pau. 1.7. Monitor:     Institute for Research (CAIBER) of the Hospital de Sant Pau. Avgda. Sant Antoni M.Claret,     167. 08025 Barcelona. Tel: (34) 93 291 9140.      1.8. Drugs: warfarin, bemiparin. 1.9. Development stage: Clinical Trial phase IV 1.10. Main     objective: To compare the incidence of gastrointestinal rebleeding and safety of oral     anticoagulation versus low molecular weight heparin in patients who have had an acute     gastrointestinal bleeding and have indication for anticoagulation.      1.11. Design: prospective open clinical trial, randomized and controlled. 1.12. Study     disease: acute gastrointestinal bleeding. 1.13. Primary endpoint of the valoration: Incidence     of gastrointestinal bleeding.      1.14. Study population and total number of patients: 20 patients were required in each group     (40 total) to objectify a decrease of rebleeding rate of 45% with an alpha error of 5% and     10% beta.      1.15. Treatment duration: 2 years. 1.16. Calendar and expected completion date: July 2011 -     July 2013   "
119067|NCT01727440|"     The goal of this study is to enroll 250 participants that have joined the MURDOCK Study     Horizon 1.5 (Duke IRB Pro00011196) with a current or prior diagnosis of severe acne AND     current or prior treatment with oral isotretinoin. All 250 participants will answer a 5-page     questionnaire designed to collect information on the diagnosis of severe acne and response to     oral isotretinoin treatment. The aim is to identify genetic predictors of severe acne     vulgaris and the outcome of oral isotretinoin treatment.   "
119068|NCT01727427|"     The same initial and long-term anticoagulation is suggested for unsuspected pulmonary     embolism as for patients with symptomatic embolism. Based on these indications, cancer     patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or     until the disease is active, which in most cases would mean indefinite treatment. In fact,     dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving     doubts over the need for (indefinite) anticoagulation which exposes these patients to an     increased risk of major bleeding events. Concerns over the need for anticoagulant treatment     may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and     sub-segmental PE seem to have a more benign course than more proximal embolism.      The scope of this study is to evaluate the current treatment approaches for unsuspected     pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of     cancer patients.   "
119069|NCT01727414|"     This study evaluates how children with Attention Deficit Disorder without Hyperactivity (ADD)     respond to medication, and if their response is different from children who have problems     with both hyperactivity and inattention. In order to do this, children ages 7-11 whose     primary difficulty is with attention problems and who have never been on behavioral or     psychiatric medications are being recruited. Once enrolled, children will try one week each     of 3 different doses of methylphenidate, the most commonly prescribed Attention Deficit,     Hyperactivity Disorder (ADHD) medication, as well as placebo. Children will be randomly     assigned to one of six possible medication dose and placebo titration schedules, but the     study doctor, family, and teacher will not know which dose (if any) children are receiving     for a given week. Each week, behavioral and side effect ratings will be completed by both the     child's parent and teacher, and the family will meet with the study doctor for a physical     examination and to discuss how each week went. Some children will also have     neuropsychological testing to determine how methylphenidate influences their working memory,     sustained attention, and ability to inhibit (stop) inappropriate responses.      All data will be analyzed to decide which medication dose the child responded to best and     further recommendations for treatment will be given. Ultimately, this study aims to improve     understanding of how children with ADHD-Primarily Inattentive Type respond to stimulant     medications by        -  determining whether these children experience a diminished response to methylphenidate          compared to children with both hyperactivity and inattention        -  determining whether certain genetic and environmental factors play a role in this          response.      Findings from this study will be used to help streamline the identification of the most     effective doses of medication for children with ADHD-Primarily Inattentive Type.   "
119105|NCT01726920|"     The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5     mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment     of migraine.   "
125824|NCT01638117|"     The purpose of this study is to determine the cumulative irritation potential of the products     listed by the Sponsor.   "
119070|NCT01727401|"     Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous     thromboembolism in high risk medical patients. A relevant proportion of these patients have     renal insufficiency and/or thrombocytopenia which represent independent risk factors for     bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients     with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg     daily, has been approved for patients with renal insufficiency defined by a creatinine     clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies     that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical     patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate     the safety of fondaparinux in high risk hospitalized medical patients with a moderate to     severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.   "
119071|NCT01727388|"     Digital rectal examination is an act clinically performed daily by physicians and surgeons.     It remains the key diagnostic test and directs the therapeutic management of cancer of the     lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.      However, no randomized study in colorectal surgery is not interested in evaluating the best     position to perform a full rectal exam.   "
119072|NCT01727375|"     The purpose of this multicenter randomised controlled trial is to investigate if circadian     light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces     prevalence of delirium in mechanically ventilated intensive care unit patients.   "
119073|NCT01727362|"     The aim of this trial is to investigate the effectiveness of acupuncture on quality of life     in patients with breast cancer receiving chemotherapy compared to routine care.   "
119074|NCT01727349|"     Considering its epidemic-like development worldwide, associated with modifications in     lifestyle, as well as its enormous social and economic weight, the prevention of type II     diabetes is certain to be a central concern of health systems within the developed countries     in the decades to come. However, while simple obesity concerns the entire population, type 2     diabetes affects only one sub-population at high genetic risk. To be effective and realistic     in economic terms, efforts at prevention must be thus targeted towards these subjects at high     risk. The key issue involves identifying such subjects early enough so that a strategy of     effective prevention can be organized in good time.      Until now, efforts have been concentrated on individuals at risk for diabetes readily     identifiable within the general population, typically subjects in the second half of     adulthood, presenting abdominal obesity and mild abnormalities of blood sugar. Preventive     lifestyle and dietary measures are proposed but are constrictive and difficult to maintain     over time, and the results, although they may be significant, remain disappointing, with mere     postponement of an outcome which at this stage appears inevitable. The reason is ascribable     to excessively tardy intervention, when the pathogenic process has already been ongoing for     some ten years and the endocrine function of the pancreas is probably already irreparably     impaired.      The alternative thus is earlier intervention, in childhood, adolescence or early adulthood.     The problem is to identify individuals at high risk of becoming diabetic at a time when they     are presenting no simple clinical or laboratory abnormalities allowing easy diagnosis. The     familial character of type 2 diabetes is now well established, and future diabetic subjects     are themselves above all the children of diabetic subjects. However, the prevalence of the     disease among the descendants of type 2 diabetic subjects is around 20-30% and predictive     tools are needed to combat diabetes in these high-risk families.      We propose to create a risk equation using an algorithm to reliably predict children most     likely to develop diabetes later in life.      The algorithm will include 3 classes of data:        -  The genotype stemming from the genetic characterization of individuals and those their          parents;        -  Environmental data concerning childhood, especially eating habits and physical activity;        -  Data of the mother who was eventually diabetic during pregnancy.      From a methodological standpoint, it would be rather difficult to take blood samples from     children and wait some 50 years to determine whether or not they develop diabetes. To     circumvent this difficulty, we will recruit subjects in families with a history of type II     diabetes:        -  Parents alive, including at least one type 2 diabetic subject        -  Adult children (aged over 35 years), some of whom are already presenting type II          diabetes, and healthy brothers and sisters, who form the control population. Test will          be done to determine whether healthy subjects are really safe from the risk of diabetes          (HbA1c measurement and glucose load test).      The Descendence study will include 500 families at risk involving about 3000 subjects (1000     subjects with diabetes and 2000 healthy subjects). It is expected to answer the following     question: for a child born in such families at risk, what is the probability of developing     diabetes later in life, so that early preventive action may be taken   "
119075|NCT01727336|"     The purpose of Part 1 of this study is to evaluate the safety and tolerability of     dalantercept in combination with axitinib in patients with advanced renal cell carcinoma     (RCC) to determine the recommended dose level of dalantercept in combination with axitinib     for Part 2.      The purpose of Part 2 of this study is to determine whether treatment with dalantercept in     combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone     in patients with advanced renal cell carcinoma (RCC).   "
144395|NCT01394393|"     Participants 60 Patients seeking treatment at the Obesity Unit of the Medica Sur Hospital in     México City, Mexico. Informed consent to participate will be aleatory assigned to a three     different conditions.      Procedures In the initial interview, prospective participants will be provided with detailed     information about the study and the treatments. All patients included in the study will be     randomly assigned to the one (N=20) of the three treatment conditions described below, all     conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will be     administered by two chartered clinical psychologists and one chartered psychotherapist under     the supervision of a senior chartered psychotherapist. The three therapists will be balanced     among the three conditions.        1. Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5          weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985),          whose goal will be to provide practical guidelines for the self-monitoring of eating and          lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction          achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day)          and physical training (30 min of walking two times a week as a minimum).        2. Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment          proposed in the first condition plus 15 additional sessions over 6 weeks.           Therapists will follow a detailed manual that outlined the content of each session. This          manual was based on the cognitive—behavioral treatment approach described by Cooper and          colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a          year of intensive pilot work and adapted to the in-patient setting. Patients will be          taught to self-monitor their food intake and eating patterns and thoughts, as well as          the circumstances and environment surrounding eating (e.g. whether eating alone or with          others, speed of eating, and place of eating). Patients will also be taught to identify          problems in eating, mood, and thinking patterns and to gradually develop alternative          patterns.           In particular, after the first week the patients will enter 5 weekly group sessions          aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed          at establishing and maintaining weight loss, addressing barriers to weight loss,          increasing activity, addressing body image concerns and supporting weight maintenance.        3. Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment          proposed in the first condition plus 15 additional sessions over 4/6 weeks.      In the sessions we will use the 20/20/20 rule. During the first 20 minutes, the therapist     focus on getting a clear understanding of the patient's current concerns, level of general     functioning, and the experiences related to food. This part of the session tends to be     characterized by patients doing most of the talking, although therapist guides with questions     and reflection to get a sense of the patient's current status. The second 20 minutes is     devoted to the virtual reality experience. During this part of the session the patient enters     the virtual environment and faces a specific critical situation (Kitchen, Supermarket, Pub,     Restaurant, Gymnasium, etc.). Here the patient is helped in developing specific strategies     for avoiding and/or coping with it. In the final 20 minutes the therapist explores the     patient's understanding of what happened in VR and the specific reactions - emotional and     behavioral - to the different situations experienced. If needed, some new strategies for     coping with the VR situations are presented and discussed. To support the empowerment     process, the therapists follow the Socratic style: they use a series of questions, related to     the contents of the virtual environment, to help clients synthesize information and reach     conclusions on their own.      In accordance with informed consent, assessments will be obtained before treatment, at     posttreatment, 3 and 6 months after the treatment conclusion.   "
119076|NCT01727310|"     Left valvular heart disease has become one of the most common heart disease in Western     countries. This disease evolve over many years and are characterized by a long phase where     the patient is asymptomatic.      it is characterized by discomfort LV filling may worsen and lead typically to a pressure     increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable     and may occur at the stage of diastolic or systolic dysfunction.      Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing     that it is often very difficult to know if the patient is actually symptomatic. The onset of     symptoms sign an intolerance to the increase in LV filling pressures and LA , causing     pulmonary hypertension .      Therefore, the study of the level of LV and LA filling pressures , if possible by a     noninvasive method, would identify patients apparently asymptomatic even though their     condition is advanced.      Pressures filling pressures can be explored by two methods:        -  cardiac catheterization, which is a direct and invasive measurement method        -  echocardiography, which is an indirect measurement method which has the advantage of          being non-invasive The goal of this research is to compare the two methods.   "
119077|NCT01727297|"     This study is to determine, through continuous monitoring with the Reveal implantable cardiac     monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high     risk for having AF and to understand how physicians manage these patients after AF has been     detected. This study will also seek to identify what patient characteristics are most     predictive of developing AF.   "
119078|NCT01727284|"     The purpose of this research is to see if MR-guided cryoablation can effectively treat     prostate tumor recurrences.   "
119079|NCT01727271|"     This study will compare monotherapy with tenofovir to sequential therapy with pegylated     interferon alpha-2b (pegIFN-2b) followed by tenofovir, and to combination therapy with     pegIFN-2b + tenofovir, in participants with hepatitis B e antigen (HBeAg)-positive chronic     hepatitis B and elevated alanine aminotransferase (ALT). All enrolled participants will be be     administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3     treatment arms.   "
119080|NCT01727258|"     This study is for people with sensitive teeth and involves going to the dentist for 4 visits     over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of     subjects, and check for sensitive teeth.      During the first 2 weeks, participants will brush their teeth two times a day with the     fluoride toothpaste provided.      Then, if they qualify to continue in the study, participants will be assigned to a treatment     group. All the groups will get toothpaste currently sold on the market, and one group will     get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal     chance of being assigned to any one of the three groups.      For the next 4 weeks, subjects will use their assigned products according to the directions     provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they     understand the directions. They will also have supervised use of the product at Visit 2.      We will see if the mouthwash helps to reduce tooth sensitivity during the study.   "
119081|NCT01727245|"     We want to asses the role of adipose tissue for metabolic complications to obesity before and     after weight loss (surgery).   "
119082|NCT01727232|"     The aim of this large French multicentric retrospective study was to compare the efficacy and     safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's     immune thrombocytopenia .   "
119083|NCT01727219|"     The frequency of depression in COPD patients are substantial and early detection and     prevention of depression is critical.      Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD     on patients' quality of life.      In this prospective study, we will investigate the predictive utility of CAT for predicting     depression in COPD patients.   "
119192|NCT01725776|"     The purpose of this study is to investigate the concentration-effect relationship of inhaled     milrinone after prophylactic administration in cardiac surgical patients with preoperative     pulmonary hypertension undergoing cardiopulmonary bypass.   "
119084|NCT01727206|"     The study we propose is a pilot phase II, interventional, treatment, open-label, single-arm,     efficacy/safety clinical trial of a 6-month treatment with tocilizumab (8 mg/kg once monthly)     in adult patients with extraskeletal Erdheim-Chester disease (ECD). Efficacy will be assessed     as the effect of the treatment on the size of the measurable lesions, as evaluated by     bidimensional measurements, and by the impact of the treatment on symptom control and on     patient quality of life. Safety of the treatment will be determined by the analysis of     adverse events and of the relevant safety laboratory parameters.      Secondary objectives of the study will be:        1. to better characterize the mechanisms underlying such disease and the possible response          to the treatment. In particular: i) we will investigate the immunophenotypic and          histomorphologic features of ECD histiocytes; ii) we will gather gene expression data          from peripheral blood immune cells to better characterize their functional status, to          define their transcriptional fingerprints and their possible modulation as a result of          tocilizumab treatment; iii) we will assess the production of soluble mediators and the          expression of activation molecules by monocytes derived from ECD patients, as well as          after stimulation with selected inflammatory cytokines; iv) we will investigate the ex          vivo and in vitro impact of tocilizumab treatment on those markers, for possible use as          a predictor or indicator of response to treatment.        2. to investigate the metabolic pattern in ECD patients before and after tocilizumab          treatment as evaluated by fluoro-d-glucose positron emission tomography (FDG-PET) and to          verify if it can be an indicator of ECD activity.   "
119085|NCT01727193|"     This is a randomized controlled clinical study. The investigators screen of eligible     patients, randomized divide into the following two groups: corticosteroids + azathioprine     group, corticosteroids + leflunomide group. The investigators treat the enrolled patients,     estimate efficacy and observed the side effects according to the requirements of program. The     investigators establish a clinical database for recording patients date and statistical     analysis. Evaluation of short-term and long-term efficacy of thymectomized myasthenia gravis     patients in the different group prove that what kind of treatment can improve the cure rate.     The investigators will evaluate the acute toxicity (gastrointestinal side effects, liver and     kidney dysfunction) and long-term toxicity (immune dysfunction, gonadal suppression) when the     investigators apply these therapy in the treatment of different clinical types of MG.   "
119087|NCT01727167|"     This study will test if inhalation of Carbon Monoxide (CO) will increase the numbers of     mitochondria in heart muscle. Mitochondria are the small components of muscle and other cells     that convert fuel and oxygen to the easily usable forms of energy (ATP) that power all cell's     activities. Adequate numbers of healthy mitochondria are essential to heart cell function.     From animal and other studies we have reason to believe that breathing small amounts of CO     will signal the body to increase the numbers of mitochondria in heart cells. We propose to     test this theory in heart valve surgery patients by examining a small sample of heart tissue     (from the right atrial appendage) that is routinely cut out during the preparation of the     patient for cardio-pulmonary bypass and that would otherwise be discarded by the surgeon.     Muscle samples from two groups of subjects will be compared. One group will breath CO and the     other group will breath room air. If CO is effective, we should notice an increase in the     numbers of mitochondria in the group that was exposed to CO compared to the group that     breathed room air.   "
119088|NCT01727154|"     The purpose of this study is to evaluate the immune response induced by sipuleucel-T     (Provenge®).   "
119089|NCT01727141|"     This study will assess the efficacy, safety and tolerability of QVA149 in patients with     moderate to severe airflow limitation.   "
119090|NCT01727128|"     To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in     subjects with mild, moderate and severe hepatic impairment   "
119091|NCT01727115|"     The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in     efficacy than NUTRAMIGEN®   "
119092|NCT01727089|"     This randomized phase II trial studies how well bevacizumab with or without anti-endoglin     monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has     spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab     and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by     targeting certain cells.   "
119093|NCT01727076|"     This phase I trial studies the side effects and best dose of recombinant interleukin-15 in     treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck     cancer that has spread to other places in the body and usually cannot be cured or controlled     with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made     naturally in the body and when made in the laboratory may help stimulate the immune system in     different ways and stop tumor cells from growing.   "
119094|NCT01727063|"     Patients with advanced coronary artery disease usually undergo incomplete myocardial     revascularization due to the extension and diffuseness of the disease, with very poor distal     arterial beds unsuitable for direct revascularization.      This study was designed to test the hypothesis that direct, intramyocardial injection of     autologous bone marrow cells may further improve myocardial perfusion in patients undergoing     incomplete bypass surgery.   "
119151|NCT01726322|"     Primary Objective :      To determine whether pre-treatment levels of anti-mullerian hormone predicts ovarian     follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and     chemotherapy induced amenorrhea (CIA).      Secondary Objective        -  To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant          chemotherapy regimens.        -  To assess the correlation between CIA and depletion of ovarian follicular reserve.        -  To partly externally validate preceding studies of anti-mullerian hormone levels in          patients receiving neo-adjuvant/ adjuvant chemotherapy for breast cancer.        -  To determine the efficacy of GNRH agonists in preservation of ovarian follicles in          premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast          cancer. Administration of GNRH agonists is dependent on the treating oncologist's          judgment of the patient's case and practices and is not to be influenced by study          participation.   "
119095|NCT01727050|"     Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for     the repair of primary unilateral inguinal hernia. Previous studies showed that patients     underwent TEP have less post-operative pain and earlier return to normal activities. However,     chronic pain is still a major issue affecting quality of life after TEP with a reported     incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation     to prevent mesh migration but nerve entrapment by staples causing intractable pain had been     reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS)     in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for     application of FS laparoscopically is now available which can achieve mesh fixation by using     fewer amounts of FS.      In this study, the investigators aim to compare the effectiveness of using fibrin spray for     mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized     controlled trial by allocating patients in two study arm in random manner. The treatment     group will have the mesh fixed by fibrin sealant spray, whereas the control group will have     conventional mechanical staples for fixation. Operative procedures and post-operative     management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month     after operation to evaluate the operative results and the incidence of chronic pain. Any     complications related to the mesh and operation will also be recorded.   "
119096|NCT01727037|"     Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy     (surgery to resect these bullae), however this is a major surgery with significant potential     morbidity and long hospital stays. Many patients are not well enough to have this surgery, or     may not wish to have it. A less invasive means of attempting to shrink the size of the bullae     is to directly inject the patients' own blood into the bullae (we believe that this can lead     to an inflammatory reaction leading to gradual scarring and volume loss). This can be     performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding     general anaesthesia).      The aim of this study is to assess the effects on lung function, quality of life measures,     functional measures and CT measured lung volumes of bronchoscopic intrabullous blood     instillation in patients with bullous emphysema.   "
119097|NCT01727024|"     This study compared the correct use of and patient preference for two drug delivery systems     (inhalers) in patients with COPD   "
119098|NCT01727011|"     Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept     whose validity is being assessed on its non-inferiority in terms of local control compared to     whole breast irradiation. At least eight phase III trials attempting to answer this question     and thus provide a sufficient level of evidence to make this concept a new standard of care     for sub-groups of patients well defined (1).      However, without waiting for the final results of these randomized trials (which will not be     fully valid with a drop of at least ten years), the American societies (ASTRO) and European     (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups     according to the risk to the patient in terms of local recurrence after IPAS. And are defined     by the ESTRO:        -  The low-risk group (suitable for ASTRO)        -  The intermediate-risk group (cautionary in ASTRO)        -  The high-risk group (not suitable for ASTRO) (2.3). Therefore, it is possible to          propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group          low risk. The results of phase II trials as a long-term analysis of the matched team          of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation          photons in low energy X whose results were recently published (5) confirm the value of          this new therapeutic concept for post-operative breast cancer at low risk of local          recurrence.      In France, the therapists were quickly directed to a sub-population for which the IPAS could     represent a real improvement in the therapeutic management in significantly reducing the     number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6).     Several French phase II trials were started specifically targeting the female population aged     using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie     (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter:     FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health     Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy     (Radiotherapy and Oncology from 09/11/11) (9).      On a technical level, two main approaches are used (10):        -  Irradiation intraoperative electron or low-energy photons,        -  Radiation after surgery The advantage of intraoperative irradiation is the optimal          reduction of total processing time radio-surgery because the patient is irradiated          during the lumpectomy. However, 15-20% of these patients receive partial breast          irradiation, as histo-prognostic criteria provided in the histologically final report,          confirm the non-adapted indication of IPAS (5).      In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS     but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days     separated by at least 6 hours).   "
119173|NCT01726023|"     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus     Metronidazole compared to Meropenem for treating hospitalized patients with complicated     intra-abdominal infections.   "
119099|NCT01726998|"     The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted     locomotor training on motor recovery of lower extremities and walking ability compared with     the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.      72 first-ever stroke patients who could not walk independently (FAC < 2), and suffered within     6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive     heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk     independently before stroke attack were excluded.      Two groups received 30 minutes conventional gait training including Neurodevelopmental     Treatment (NDT) basically. The robotic assisted locomotor training group received additional     robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily     for 4 weeks, and the conventional gait training group received additional daily conventional     gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3),     Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA),     Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles     were assessed before, during (2weeks) and after training. And the independent walking ability     were followed until 3 months.   "
119100|NCT01726985|"     Heart failure is the leading cause of hospitalizations and readmissions in the United States     and is a tremendous economic strain on our healthcare system. There is currently, based on     national averages, a 30% readmission rate and 10% mortality rate within 3 months of being     hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers     such as BNP to guide inpatient heart failure management. Our own CCF retrospective study     showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L,     and discharging patients with serum sodium above 135 reduces readmission rates significantly.     The purpose of this study is to prospectively use the above mentioned goals in the treatment     of heart failure in order to reduce heart failure readmission and mortality rates.   "
119101|NCT01726972|"     The proposed study aims to objectively assess 2-year clinical and radiographic results for     the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This     retrospective radiographic review will provide evidence for equivalence or superiority in     curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is     utilized in conjunction with cement at the glenoid.   "
119102|NCT01726959|"     The objective of this study is to identify genetic predictors of individual methotrexate     (MTX) response in patients with rheumatic diseases by determining genetic and metabolomic     factors related to nutrient metabolism and drug transport.      The development of better genetic predictors of individual MTX treatment response would     provide invaluable prognostic information prior to initiating treatment, which would allow     more appropriate choice of therapy, decreased adverse events, and more efficient     dose-escalation of the drug, with ultimate benefits of improved effectiveness and     tolerability rates in patients being treated with MTX for autoimmune diseases.      Despite being the gold-standard therapy for rheumatoid arthritis and other types of chronic     autoimmune diseases since 1951, MTX's efficacy and safety profile limit its use: MTX is     discontinued in greater than 50% of patients secondary to inefficacy or poor tolerability.     Upon initial treatment, discontinuation rates approach 12% because of drug toxicity, despite     prophylactic measures such as the co-administration of folic acid. The causes of primary     failure, secondary failure, and adverse events of MTX may be related to genetic variation of     dihydrofolate reductase (DHFR) and other genes involved in folate metabolism, one-carbon     transfer, and drug transport. The purpose of this study is to identify genetic variations     involved in methotrexate response so that we may better understand the pharmacodynamics of     MTX metabolism in patients with rheumatic diseases.   "
119103|NCT01726946|"     A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135     in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C   "
119104|NCT01726933|"     The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to     active control and placebo in patients with moderate to severe chronic plaque psoriasis   "
119106|NCT01726907|"     Traditional transcervical incision of the upper neck is a safe and effective approach for     resection of the submandibular gland (SMG). However, external scar at the highly visible area     may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or     keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted'     and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes     since the scar was hidden by the auricle and hair. In our previous feasibility study of     robot-assisted SMG resection, the investigators proposed that robot-assisted technique may     overcome the limitations of endoscopic instruments with rigid and straight nature without     articulation and surgical view of two-dimension. In addition, the ergonomically designed     operating system was more convenient for the surgeon considering the frequent collision of     the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery.     However, clinical trial comparing the surgical outcomes of the two techniques has not been     reported in the literature.      In this study, the investigators made a prospective comparative study of robot-assisted     versus endoscope-assisted SMG resection to determine whether robot-assisted technique has     benefits regarding early surgical outcomes.   "
119107|NCT01726894|"     To determine the adverse events and genito-urinary side-effect profile of focal therapy to     treat localised low to intermediate risk prostate cancer using irreversible electroporation     (Nanoknife™).   "
119108|NCT01726881|"     People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to     80% of the patients will develop chronic pain called central pain and describe the pain as:     burning, stabbing, or like electricity. Central pain mechanism is unknown and therefore     treatment is currently not effective.      It is hypothesized that chronic pain is associated with impaired function of the systems     regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury     patients. Presence of such a connection, between the regulating system dysfunction and     central pain, will help both predicting the risk of central pain and develop a treatment.      The current research objective is to make several sensory measurements which will measure the     functioning mechanisms of regulation and control of the pain. These measurements are accepted     throughout the world and are based on psychophysical assessment of patients. these     Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients     demonstrate impairment in the regulation of pain. Finding such a link between central pain     and impaired regulation could shed light on the mechanism of central pain. In addition, these     measurements are designed to assess whether fresh spinal cord injury patients that have not     yet developed central pain demonstrate impairment in the regulation of pain immediately after     the injury. By repeated assessments of pain regulation capabilities, which will be made to     fresh Spinal Cord Injury patients during the first months of injury, and comparing the     results of these measurements between those who will develop center pain and those who will     not, we could identify indicators for predicting the risk of central pain. Another goal of     the study is to investigate the efficacy of central pain treatment, using a TENS, when the     parameters of the TENS treatment will be built according to the level of functioning of the     regulating systems of the individual.   "
119110|NCT01726855|"     The purpose of this study was to report a new method of flexor tendon repair in zone II with     combined standard modified Kessler technique and vascularized finger dorsal fascial flap     pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to     finger volar for placement of a mechanical barrier between flexor digitorum superficialis     /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair     in zone II with this new technique were compared with those of 32 patients (Group B) with     flexor tendon repair in zone II with standard modified Kessler technique. This new technique     may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.   "
119111|NCT01726842|"     The purpose of this project is to compare the performance of the Pediatric Vision Scanner     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at     detecting amblyopia and strabismus.   "
119112|NCT01726829|"     This is a randomized prospective single blind trial to evaluate blood glucose control     overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system     in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia     and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will     participate in four consecutive over nights under closed-loop with MDLAP, and four additional     over nights under regular sensor augmented pump therapy at home with a washout period of 10 ±     3 days between arms.   "
119113|NCT01726816|"     This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial.        -  Screening period (4 week)        -  Double blind treatment period (16 weeks)   "
119114|NCT01726803|"     Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped     care approach with initial treatment of education and advice to remain active. Referral to     physical therapy is considered only when patients fail to recover after a few weeks. Recent     research has led to the identification a subgroup of patients likely to experience rapid,     pronounced, and sustained decreases in disability and pain with a brief manipulation and     exercise intervention, suggesting it may be more cost-effective to manage this sub-group with     early referral to physical therapy instead of the usual care approach. The integration of     this evidence into routine practice has not been evaluated. We will assess the outcomes of     integrating this evidence into the management of patients with low back pain. The study is a     randomized trial, comparing management with early manipulation with the current care process     model. Patients fitting the inclusion criteria will be randomized into one of two groups. One     group will be managed with the current care process model. The other group will be managed     consistent with the decision rule recommending early referral for a brief manipulation and     exercise intervention during the first 4 weeks. Patients will be followed over 1 year.     Outcomes will include measures of disability, pain, satisfaction, and direct medical costs.     The study will examine the costs and effectiveness of integrating the alternative care model     into practice.   "
119115|NCT01726790|"     To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection   "
119152|NCT01726309|"     Primary Objective:      Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and     the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region.      Secondary Objectives:      Correlation of SNP profile with indicators of tumour response parameters, such as     radiological response, duration of response, time to progression (TTP), overall survival (OS)     time, incidence of non-dermatological adverse events.   "
119153|NCT01726296|"     This clinical trial studies adherence to survivorship care guidelines in health care     providers for non-small cell lung cancer or colorectal cancer survivor care. The completion     of an educational intervention by health care providers may increase compliance and adherence     to National Comprehensive Cancer Network guidelines for survivorship care.   "
119116|NCT01726777|"     Type 2 diabetes (T2D) is an increasingly common and serious condition. Studies show that low     vitamin D levels are associated with increased diabetes risk and that vitamin D may protect     against diabetes by reducing chronic inflammation and improving insulin sensitivity and     insulin secretion. However, no studies have been able to show that vitamin D actually reduces     post-prandial blood glucose levels, the most clinically relevant marker of diabetes.     Previously the investigators have shown that cheddar cheese and low-fat cheese can be     fortified with high levels of vitamin D and that this cheese is at least as a effective as     vitamin D supplements in raising blood vitamin D levels.      The main purpose of this study is to see whether vitamin D enriched cheese can improve oral     glucose tolerance (reduce blood glucose 2 hours after consuming a drink containing 75g sugar)     in people who have low vitamin D levels and are at risk for developing T2D.      Other aims are to determine the effect of vitamin D may on insulin sensitivity, insulin     secretion, markers of inflammation, blood cholesterol levels, and safety markers such as     urinary calcium excretion.   "
119117|NCT01726764|"     The goal of the study is to examine the difference of the pharmacokinetics of metformin with     and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives     include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose     tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile     following this possible interaction.   "
119118|NCT01726751|"     To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a 4-polar     electrode at the T5-8 level is implanted. In a randomized, cross-over study design, active     stimulation is compared to a period without stimulation, with an ensuing tailing stimulation     period, twice as long. Patients recorded average pain level, pain attacks, number of     diarrheas and global quality of life. At the end of the study patients can choose to retain     their SCS stimulation system or have it removed.      The outcome of the present trial will show whether SCS is a useful treatment of IBS. The     long-term follow-up will show the continuous amelioration of SCS over at least six months.   "
119119|NCT01726738|"     This phase II study in 20 patients with BRAFV600E mutant, unresectable stage III/IV melanoma     is designed to explore the mechanisms by which tumors acquire resistance to the combination     of a BRAF inhibitor (dabrafenib) and MEK inhibitor (trametinib). Tissue will be collected at     baseline and at progression. Markers of resistance will be explored by performing near     kinome-wide profiling on tumor samples, and in patients who co-enroll in institutional     protocol LCCC1108, by sequencing tumors using NextGen DNA sequencing technology. Overall     response rate and duration to this combination will also be assessed.   "
119120|NCT01726725|"     Patients are chosen to participate in this study because they will undergo a particular type     of brain surgery to treat their hemifacial spasm. This surgery is called microvascular     decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by     one or more blood vessels and this contact produces the facial twitches. The investigators do     not know why a blood vessel that touches the facial nerve produces facial twitches. The     investigators are interested in investigating this during your surgery. A total of 25     participants are expected to participate in this study.   "
119121|NCT01726712|"     The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and     culturally sensitive intervention designed to capitalize on organic yet underutilized social     support networks in the lives of young black men who have sex with men (YBMSM) who have been     recently diagnosed with HIV. The intervention has been developed with input from clients and     their support network members, case managers, social workers, HIV primary care providers and     pastoral care at a Federally Qualified Health Center. The goal of the intervention is to     improve retention in care for newly diagnosed YBMSM who present for their first HIV primary     care clinic appointment.   "
119122|NCT01726699|"     Study the genetic traits of cancerous tissues and to help improve cancer treatment by     developing tumor models for studying new cancer drugs.   "
119123|NCT01726686|"     The purpose of this study is to evaluate the effect on postoperative pain and function by     adding intraarticular continuous infusion pump with local anesthetic after total knee     arthroplasty where local infiltration analgesia has already been given.   "
119124|NCT01726673|"     The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct     Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy     lead to a greater functional recovery in upper limb mobility after stroke than that provided     by robotic arm therapy alone.   "
119125|NCT01726660|"     The purpose of this study is to determine if tailoring multiple sessions of upper extremity     robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming;     active range of motion vs. functional practice)can optimize therapeutic results and lead to     greater functional returns in arm mobility after stroke.   "
119126|NCT01726647|"     Objectives:      The primary objective of this clinical trial is to characterize metabolic signatures     associated with abdominal fat distribution in 40 women with different BMI 29-40 and different     abdominal distribution of fat (visceral vs. sub-cutaneous fat).      No intervention with a product is planned. The subjects will be given one high fat meal with     commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to     test the post-prandial metabolic response.   "
119127|NCT01726634|"     Evaluate if the elastic tapping application on the scapular region can interferer immediately     on the performance during the upper limb closed kinetic chain test on jiu jitsu     practitioners.   "
119128|NCT01726621|"     This six center international study will include two United Kingdom National Health Service     centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The     objective of the study is to evaluate subject acceptance of the a new insulin pump and     transmitter together with the accompanying training materials. Descriptive data from     participant questionnaires and device uploads will be evaluated.      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of     age upwards, who currently use an insulin pump in the management of their type 1 or type 2     diabetes, will be invited to participate. Each subject will be trained on the study device     and then use it for approximately six weeks. During this time there will be three in-clinic     visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of     this period, they will revert back to their original insulin pump and complete a     questionnaire on the study pump training materials, features and usability.   "
119129|NCT01726608|"     The purpose of the study is to investigate if a technique called Simplicity III®     Radiofrequency Neurotomy is effective in improving the management of sacroiliac joint pain.     Currently there are a variety of treatments for managing this pain but there is still some     doubt as to which treatments are the most effective. Simplicity III® is one such treatment     for sacroiliac joint pain and has been used in the NHS for many years. It uses electrical     current to generate heat around the tip of the needle placed close to the nerves that supply     the sacro-iliac joint. This heat ablates the specific nerves supplying the joint and improves     pain.      The traditional method used to treat this type of pain uses multiple injections to target the     nerves supplying the joint. This method is however both time consuming and the results are     variable depending upon the number of injections. Therefore a new electrode, called the     Simplicity III®, was developed to allow the treatment to be undertaken using fewer     injections. Although this treatment has received formal approval, undergone conformity     assessment and is available in certain specialist NHS centres for clinical use, there is     presently limited evidence with regards to its clinical efficacy. We wish to test the     effectiveness of this new device in treating sacroiliac joint pain. The best way to prove the     clinical effectiveness is to compare Simplicity III® against an identical procedure where the     electrode is not switched on and neither the patient nor the doctor is aware whether it was     switched on. Once pain has been assessed at 3 months, those patients not receiving active     treatment and remaining in pain will be offered the active treatment.   "
119130|NCT01726595|"     The investigators hypothesize that doctors and nurses can undergo a brief period of training     and then use ultrasound to accurately measure blood flow in a forearm artery after a brief     period when this flow is interrupted with a blood pressure cuff, a measurement the     investigators call reactive hyperemia. Reactive hyperemia indicates whether the small blood     vessels in the body are healthy -- lower reactive hyperemia indicates worse small blood     vessel function. When measured by experienced ultrasound experts, low reactive hyperemia     strongly predicts death in critically ill patients with infection (severe sepsis).      The investigators are conducting this study to determine if doctors and nurses, without     specific pre-existing expertise in ultrasound, can be trained to make these measurements     accurately. If so, the investigators will prove that these measurements can be applied     reliably in real-world practice.      The investigators also hypothesize that reactive hyperemia predict the outcomes of illness     not just in patients with severe infection, but in other critically ill patients as well.      Finally, the investigators hypothesize that reduced blood flow after blood pressure cuff     occlusion is linked with other abnormalities of blood, previously identified in critically     ill patients. For example, red blood cells from patients with severe sepsis have been shown     to be stiffer than normal, so they are less able to flow along the small blood vessel     passages of the body. Red blood cells become stiffer when there is a certain type of stress     in the body known as oxidative stress.      If the investigators show that low reactive hyperemia, stiff red blood cells, and oxidative     stress are linked, the investigators hope to develop new treatments that reduce oxidative     stress, reduce the stiffness of red blood cells, and in turn improve reactive hyperemia.     Improvements in reactive hyperemia indicate improvements in small blood vessel function.     Better small blood vessel function means better delivery of oxygen throughout the body. The     investigators believe that this will improve outcomes for critically ill patients.   "
119131|NCT01726582|"     See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm     :      In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is     cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular     profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy     and radiation therapy) that the patient will receive before having surgery to remove the     adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is     tested again. The results of that test are used to guide the choice of therapy after surgery.      The chemotherapy drugs and the radiation therapy used in this clinical trial are already     approved for treatment of pancreas cancer. This trial is intended to establish which     treatment is best for a specific patient, based on test results from that patient's actual     adenocarcinoma. In the past, the decision as to which treatment the patient will receive was     not based on testing of the actual adenocarcinoma.      Hypothesis: Resectability rate, overall survival rate and progression-free survival will be     superior in patients with adenocarcinoma of the pancreas who receive targeted personalized     therapy, as compared to historical data of patients who received standard therapy.   "
119132|NCT01726569|"     1. Investigate degree of postoperative satisfaction in county level hospital glaucoma          patients.        2. Investigate the effect of educational intervention affect the degree of satisfaction in          glaucoma patients.        3. Investigate the effect factors of postoperative satisfaction.   "
119133|NCT01726556|"     Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for     undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument     designed for the same purpose which is claimed to be more user-friendly. The two devices have     not been compared in a head-to-head trial in published literature. The investigators attempt     to conduct a randomised comparative trial between the two devices.   "
119134|NCT01726543|"     It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep     Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a     Randomised, Prospective Study.   "
119135|NCT01726530|"     Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually     applied but there is no perfect choice. It depends on physician's skill and situation. The     best regimen is patient-controlled analgesia, but it requires an expensive equipment.     Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release     fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.      Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may     provide good analgesia for 72 hours.   "
119136|NCT01726517|"     This study is to evaluate the safety, tolerability, and antiviral efficacy of     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV),     administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis     C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had     previously received a regimen containing a protease inhibitor for the treatment of HCV.   "
119137|NCT01726504|"     The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe     functional constipation compared with sham acupuncture, used as placebo; the secondary     purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.   "
119138|NCT01726491|"     The investigators are trying to understand the role of DNA (deoxyribonucleic acid)     methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a     normal chemical process in the body that modifies DNA. By studying this, the investigators     hope to better understand the causes of insulin resistance.   "
119139|NCT01726478|"     The purpose of the study was to determine whether 2.5 international units of oxytocin gives     adequate uterine tone and is safe as compared to 10 international units of oxytocin following     caesarean section delivery at Mulago hospital.   "
119140|NCT01726465|"     This is a prospective double-blind randomized phase II clinical trial, with two groups of     intervention (one with administration of N-acetylcysteine and the other with administration     of methylprednisolone), and one group of placebo. The purpose of this study is to investigate     the role of N-acetylcysteine and Methylprednisolone in the modulation of warm ischemia of the     liver during hepatic resection. In fact to avoid massive blood loss in liver surgery,     continuous or intermittent vascular clamping of the hepatic hilum ('Pringle maneuver') is     generally used with good results. However, as a consequence, ischemia and subsequent     reperfusion result in complex metabolic, immunological, and microvascular changes, which     together might contribute to hepatocellular damage and dysfunction. This phenomenon, known as     ischemia-reperfusion (IR) injury of the liver, is a complex multi-path process leading to the     activation of some inflammatory pathways. Any patient candidate to liver resection will be     enrolled in the study based on the aforementioned criteria. The primary objective of the     study is to assess the real efficacy of Methylprednisolone and N-acetylcysteine in reducing     the secondary damage from ischemia reperfusion injury in liver resection and in reducing     inflammatory response. Secondary objective of the study is whether the reduction of     ischemia-reperfusion injury results in: lower incidence of postoperative liver failure,     improvement of postoperative liver function, and reduction of blood components transfusions.     The randomization will be done the day before the operation. The drugs will be prepared in a     blind fashion by the hospital pharmacy. The hospital pharmacy will provide to each patient a     drip to make bolus of about an hour before the start of the liver resection and a syringe     pump for an infusion of approximately 6 hours. If the patient is enrolled and randomized in     the placebo arm, he/she will receive 250 ml of glucose 5% plus the infusion of 100 ml of     glucose 5% If the patient is randomized in the Methylprednisolone arm, he/she will receive a     dose of 500 mg in 250 ml of glucose 5% plus 100 mg of glucose 5%. If the patient is     randomized in the N-acetylcysteine arm, he/she will receive a dose of 150 mg/kg in 250 ml of     glucose 5% plus N-acetylcysteine 50 mg/kg in 100 ml glucose 5%. Systematic sampling of liver     function tests will be done the day before the operation, at the end of the operation, as     well as in postoperative day 1, 3, 5 and 7.   "
119141|NCT01726452|"     Primary Objective:      To evaluate one, two and three year survival of patients treated with resection plus     neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy.      Secondary Objective(s):      To evaluate the effect of both neoadjuvant regimens on clinical and pathological response     rate (in particular relief of dysphagia, improvement in health related quality of life     (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression     grade, node-positivity, post-operative pathology, disease-free survival, time to treatment     failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL).      Exploratory Objective(s):      Translational Research: The collection of blood and tissue samples for storage in the bio     bank for future research.   "
119142|NCT01726439|"     To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of     Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy,     de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B     (CHB) patients who are naive to NUC at enrollment to this study   "
119174|NCT01726010|"     The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy     Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the     upper gastrointestinal tract.   "
119143|NCT01726426|"     The role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not     known. This can be evaluated by administering probiotics. Thirty patients from an arsenic     affected area will be provided two probiotics capsules per day orally for 12 weeks and stool     samples will be collected for qualitative and quantitative analysis of anaerobic bacteria.     Similar number of arsenic exposed controls and healthy volunteers from the same area will be     included with similar protocol for comparison. Like aerobic bacteria, anaerobic bacteria may     be modulated by probiotics in arsenicosis patients.   "
119144|NCT01726413|"     Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent     injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,     and costs from a public health perspective. Painful diabetic neuropathy affects approximately     16% of patients with diabetes. Pharmacological agents used in the management of painful DPN     mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake     inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give     total relief, are not effective in all patients, and only about one-third of patients may     achieve more than 50% pain relief. Hence newer therapies are required for the treatment of     DPN. The primary outcome measures will be the change from baseline to end of treatment in the     mean 24-hour average pain intensity.   "
119145|NCT01726400|"     The standard treatment of chronic hepatitis C infection is pegylated interferon alpha     combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects.     Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions,     reducing the likelihood of sustained viral response. Recent data shows that interferon alpha     may increase hepcidin (a key iron regulator) production, resulting in impaired iron     availability for production of red blood cells. In this study, we will evaluate hepcidin     levels in 30 patients with Hepatitis C who are treated with interferon containing regimes. If     hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral     hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha     induced anaemia.   "
119146|NCT01726387|"     Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often     these conditions remain undiscovered and/or untreated.      In order to ease this urgent health care problem in the future, the investigators conduct a     cluster-randomized controlled trial, implementing a tandem working cooperation between a     nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its     own practise.      The CA's task is to enhance the patients abilities to engage in a better self-management of     their psychological symptoms and complaints, to enhance self-efficacy and empower the     patients to tackle problems of daily living.   "
119147|NCT01726374|"     High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP     (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the     40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles     of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these     patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more     chemotherapy cycles on a population basis.      If a single cycle of BEP at the dose used in advanced disease had a similar high rate of     relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the     overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a     change in practice globally.   "
119148|NCT01726361|"     The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care     compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home     placement.   "
119149|NCT01726348|"     The purpose of this study is to assess the safety and effectiveness of darunavir for the     treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.   "
119150|NCT01726335|"     The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting     risperidone when switching from oral antipsychotics in participants with schizophrenia     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often     with delusions and hallucinations, and withdrawal into the self).   "
119157|NCT01726244|"     One of the most cost effective intervention is to avoid unnecessary hospitalizations in the     national health system. These unnecessary admissions are increasing for several years,     reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or     heart failure at two months of hospital discharge. There is scientific evidence suggesting     that a multidisciplinary intervention consisting in controling disease and stress associated     with disease, and modifying eating habits could reduce the number of hospitalizations due to     disease decompensation.      The main objective of the study is to assess the rate of readmissions at year of     multidisciplinary intervention in patients with COPD and / or heart failure.      We will select 144 patients who will be randomized to two groups (control and intervention     group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months     and 12 months of hospital discharge).      Patients assigned to the intervention group will be receive three educational sessions (one     of them will be imparted by nursing, another by the nutritionist and the last one by the     psychologist). In addition, patients with a BMI <20 and / or> 30 will receive a closer     monitoring by the nutritionist).      Patients assigned to the control group will receive usual care in clinical practice.   "
119158|NCT01726231|"     In laparoscopy, over %50 of the all complications occur during establishment of the     pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance     between the abdominal wall and the intrabdominal structures. Elevation of the anterior     abdominal wall is recommended for the access to peritoneal cavity in literatures however the     benefit exactly has not proved. This study aimed to determine the distance from anterior     abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to     represent this distance -on the average- generate the safe range whether or not and compare     with this distance and patient's age, BMI and parity.   "
119175|NCT01725997|"     The study aims to answer if surgery with hook plate for acute dislocation of the     acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to     conservative treatment.   "
119176|NCT01725984|"     A single-center retrospective chart review of AdVance and AdVance XP subject data, combined     with prospective follow-up of the same subjects to confirm continence, adverse event, and     quality of life status. This study includes patients previously implanted with an AdVance or     AdVance XP male sling.   "
119159|NCT01726218|"     It is well known that the motor area of one hemisphere of the brain (motor cortex) controls     the movement of the opposite of the body. However, it is not clear whether as the movement     becomes more complicated, the motor cortex of both hemispheres of the brain are involved.     Currently the role of the motor cortex on the same side of the body (referred to as     ipsilateral motor cortex) in hand performance remains controversial. The investigators     demonstrated previously in healthy subjects that transiently lowering the activity of     ipsilateral motor cortex improved the performance of the opposite hand. What is not know are     the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation (TMS)     is a device that allows the non- invasive stimulation of the brain. When brain is stimulated     repetitively at a very low rate and low intensity for about 15 minutes, the stimulated brain     area becomes less active. This effect lasts 10 minutes and is called a transient artificial     lesion as it mimicks the effects of transiently interfering with the function of the     stimulated brain area. In the present study the investigators will conduct experiments using     repetitive TMS to downregulate the activity of the motor area as in previous experiments and     measures its effect on activity of motor cortex of both hemispheres. The investigators will     study healthy subjects. It would be important to understand the effects in more detail for     the design of treatment strategies in patients after stroke, which will be a topic of future     studies.   "
119160|NCT01726205|"     The purpose of this study is to assess the efficacy of pregabalin or pregabalin and     continuous wound infusion versus placebo for analgesia following thoracotomy   "
119161|NCT01726192|"     The purpose of this study is to assess the efficacy of the hydrolocalization technique for     placement of femoral perineural catheters in comparison with stimulating catheters. A non     inferiority trial.   "
119162|NCT01726179|"     the goal of the project is to investigate the clinical efficacy of management of early caries     lesions by resin infiltration and to further scrutinize the patient stress experiences.   "
119163|NCT01726166|"     Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up     to 10%. It is more frequent in male and preterm newborn infants and can lead to significant     problems in infants including blood infections, kidney infections, and kidney scarring which     can affect how the kidneys work later in life.      Analysis of collected urine for the presence of bacteria or fungus is the only way to make a     certain UTI diagnosis. Urine culture results may take 24 to 48 hours to become available.     Sterile collection of urine can be achieved in newborn infants by urinary catheterization     (UC) where a catheter is passed through the urethra into the bladder, suprapubic aspiration     (SPA) where a needle is inserted into the bladder through the abdominal wall, or 'clean     catch' where urine is collected into a sterile bottle as the baby urinates during preparation     for UC. The main advantage of SPA is that it bypasses the bacteria that normally resides in     the urethral opening, thus minimizing the risk of contamination. Some studies have suggested     that SPA is better than UC for collecting urine in a sterile fashion in the neonate due to     the difficulty of doing sterile UC in small infants resulting in more contaminated samples     (also called a false-positive urine culture); there are some problems with the way these     studies were done so there is still no clear best choice. UC is commonly used in many     Neonatal Intensive Care Units (NICU) as it is considered less invasive, can be done by the     nursing staff, and generally has a higher chance of obtaining urine. SPA is a simple and safe     alternative and, although some studies suggest that it is more painful than UC, it it     performed more quickly. The reported success rate for SPA is variable, but is greatly     increased when an ultrasound confirms urine in the bladder before doing the SPA. The question     remains: what is the best method for sterile collection of urine in newborns and young     infants? In this study, the investigators will try to answer this question by collecting     urine from infants admitted to our NICU using either ultrasound guided SPA or UC and then     comparing the contamination rates between these two methods.      The investigators hypothesize that SPA will result in less contamination of urine samples.      The investigators also hypothesize that there will be more success in obtaining an adequate     urine sample (0.5 ml) by SPA, SPA will be quicker to perform, and that there will be no     difference in associated complication rates between SPA and UC.   "
119164|NCT01726153|"     The purpose of this study is to evaluate the efficacy of an online intervention in increasing     condom use among HIV+ gay males.   "
119165|NCT01726140|"     The aim of study is to evaluate whether the application of a continuous positive airway     pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia     and re-intubation rate.   "
119201|NCT01725659|"     PURPOSE. After stroke many patients are unable to engage in normal upper limb functional     activities, which may restrict them from participation in meaningful life roles. For many,     conventional rehabilitation does not restore upper limb function to a useful level. The     purpose of this research is to investigate the benefits of three promising motor learning     interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning     (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).   "
119202|NCT01725646|"     1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients        2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients   "
125825|NCT01638104|"     The purpose of this study is to investigate the safety and tolerability of ANX-042 when     administered by continuous intravenous (IV) infusion in healthy volunteers.   "
119166|NCT01726127|"     The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups     fruits and vegetables daily. However, at current intake levels, fruit consumption will have     to improve by more than 100% and vegetable intake by 50% to meet this recommendation.     Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are     not considered. It is possible that improved fruit and vegetable intake will have beneficial     health effects. For example, higher intakes of fruits and vegetables, and particularly     cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated     with lower rates of many degenerative diseases, including some cancers, yet this group of     vegetables may continue to be under-consumed due to their strong flavors. A supplement made     from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI)     contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism     in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the     urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study,     the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM     whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy     premenopausal women will be compared over an eight-week period. The investigators hypothesize     that treatment with daily supplements will increase the 2:16 ratio as compared to daily     consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting     reduced breast cancer risk.      In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,     lutein and lycopene with dietary carotenoid intake as measured by a food frequency     questionnaire and body composition will be evaluated in healthy premenopausal women.     Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues     and their concentration in human blood reflects dietary intake of carotenoid-rich foods.     Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual     status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations     may serve as a functional marker for chronic disease risk associated with excess body fat.   "
119167|NCT01726114|"     The purpose of this study is to compare glucose measurements from the C8 MediSensors     non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow     Springs Instrument(YSI) blood glucose analyzer.   "
119168|NCT01726088|"     The purpose of this study is to determine if modafinil is more effective than placebo in the     treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been     deployed to Iraq or Afghanistan.   "
119177|NCT01725971|"     Silicosis is a chronic and incurable occupational disease that can progress independent of     the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may     help to improve our understanding of the changes in lung mechanics, as well as in the     detection of these changes.      Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory     impedance and evaluated the diagnostic use of the FOT in these patients. For this, the     investigators used spirometry to classify airway obstruction, which resulted in four     categories: control, patients with normal exam, mild obstruction, and moderate-to-severe     obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the     resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the     mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was     evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic     potential was evaluated by investigating the area under the receiver operating characteristic     curve (AUC).   "
119178|NCT01725958|"     Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement     Combination on Body Weight Management over a 90-day period   "
119179|NCT01725945|"     Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot     study aims to provide effect size estimates and justification, clinical trial and     intervention feasibility data, and procedural materials for a full-scale randomized     controlled trial that will determine the efficacy and mechanisms of action of the Dietary     Approaches to Stop Hypertension (DASH)—a recommended dietary pattern based on proven     cardiovascular benefits—as adjunct therapy to standard care for adults with uncontrolled     asthma.   "
119180|NCT01725932|"     While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression     in West, only limited amount of research has been conducted to find assess its effectiveness     in low and middle income countries. We have developed culturally sensitive CBT during the     last few years in Pakistan. Pakistan has high rates of depression. And there is currently a     need to develop and test evidence based treatments which are culturally sensitive and cost     effective. IN this project we will be assessing the effectiveness of a culturally sensitive     CBT based self help intervention for depression in Pakistan against care as usual, using a     randomized controlled design.   "
119230|NCT01725282|"     In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major     depressive disorder patients with lack of response to existing antidepressants, with the aim     of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose     groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.   "
119181|NCT01725919|"     Constraint-induced movement therapy (CI therapy) is a highly efficacious treatment for     residual motor disability in chronic stroke. Its effectiveness is believed to be due, at     least in part, to the therapy's ability to aid the brain in rewiring itself. For example,     CI therapy produces increases in the amount of grey matter (the parts of the brain where     neuron cell bodies are most closely clustered) in certain areas of the human brain (Gauthier     et al., 2008). The cellular and molecular mechanisms that are responsible for this increase     in grey matter volume are not known, however. Thus, it is unclear how the therapy helps     brains rewire themselves. This study aims to better understand the timecourse and     cellular/molecular nature of brain changes during CI therapy. Because there is currently no     way to directly measure cellular/molecular changes in the brain noninvasively, this study     will infer what is happening on a microstructural level using new MRI techniques (three     dimensional pictures of the brain). For example, by charting the timecourse of grey matter     changes during CI therapy, and cross-comparing this to what is known about the timecourses of     different cellular/molecular processes, the investigators can gain a greater understanding of     what cellular processes may be responsible for increases in grey matter. The investigators     will gain additional information about which cellular processes are important for     rehabilitation-induced improvement by measuring larger-scale changes (e.g., amount of blood     flow through different brain areas) that accompany cellular changes. The investigators are     hopeful that by better understanding how CI therapy can change the brain, the effectiveness     of rehabilitation can be improved upon. For example, insight into the mechanisms of     rehabilitation-induced brain change may suggest particular drug targets to increase brain     plasticity. This study will help us better understand how the brain repairs itself after     injury.   "
119182|NCT01725906|"     We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs.     empiric therapy in the third line therapy. Factors affecting the eradication rates, including     the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.   "
119183|NCT01725893|"     Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the     treatment of choice and many methods have been proposed. The purpose of this study is to     evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor     tendons.   "
119184|NCT01725880|"     The purpose of this study is to determine the long term safety and preliminary efficacy of     intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord     trauma.   "
119185|NCT01725867|"     the purpose of this study is to compare the effect of physical therapy (PT) program and oral     appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).   "
119186|NCT01725854|"     The purposes of this study are to evaluate the acceptability and utility of a mind-body     intervention on a convenience sample of Soldiers (n=120) who have screened positive through     RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness     of this Relaxation Response (RR) intervention designed to decrease the physiological and     psychosocial effects of stress and trauma. The study aims to enhance the psychological health     of Soldiers with a RR intervention designed to promote self-awareness of physiological     responses to stress and the ability to increase relaxation responses.   "
119197|NCT01725711|"     Patients with transfemoral amputations (TFA) frequently experience problems related to the     use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps     4. The potential for improvement is substantial. Based on the very good long-term results     with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing     aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the     clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg,     Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical     trial began.      The hypothesis is that the treatment will improve quality of life.   "
119225|NCT01725347|"     The Validation of a Digital Diet Method project is very innovative because it links three     methods to address the gap in measuring food intake of HS preschool children. Data collection     is based on EMA theory; participant burden is low, and the Food Image App decreases     participant and staff burden even further. Data management and analysis are semi-automated     and relies on advanced computer algorithms. A strength of this approach is its     semi-automation, which allows us to leverage the strengths of human operators and computer     automation.   "
119187|NCT01725841|"     Resistance to broad-spectrum cephalosporins through the acquisition and expression of     Extended-Spectrum β-lactamase (ESBL) among Enterobacteriacea is increasing. The clinical     implications of ESBLs are extremely serious and sensitive diagnostic methods are urgently     needed to guide therapy, monitor resistance development and implement intervention     strategies. Conventionally, detection of expression of ESBLs was based on reduction of     ceftazidime of cefotaxime MICs by ≥ 3 two fold dilutions in the presence of clavulanic acid.     However, the use of the above method was limited to cover only some of the bacterial species,     including predominantly E. coli and Klebsiella spp., or tested strains which were all     transconjugants generated in vitro. ESBLs are now reported in a growing number of genera     other than E. coli or Klebsiella spp., and Serratia marcescens.      Carbapenems, including ertapenem, imipenem and meropenem, are the drugs of choice used for     severe ESBL-producing bacterial infections. Failure to detect ESBL at the presence of AmpC     β-lactamase might result in an important clinical concern because 4th generation     cephalosporins, which are stable to AmpC β-lactamase, is not a drug of choice for severe     infections caused by ESBLs-producing isolates. Fluoroquinolone-resistance in ESBL-producing     Enterobacteriacea is common. In this study, the investigators will use isolates of     Enterobacteriacea collected from different hospitals (isolates offered by the Taiwan     Surveillance of Antimicrobial Resistance [TSAR] program) to investigate the susceptibility of     ertapenem and five other antimicrobial agents against ESBLs-producing Enterobacteriacea.   "
119188|NCT01725828|"     Routine surgery requires artificial breathing through the placement of a plastic tube into     the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen     to the patients during surgery. Difficulties during insertion of this tube may lead to     serious complications and during this life-threatening crisis the only way to provide oxygen     to the patient is by the help of a procedure called cricothyrodotomy (CTY).      CTY is a live saving procedure that involves an incision on the patient neck at a very     precise location called Cricothyroid Membrane (CTM). The current method of identifying this     location is by palpation of neck cartilages by the operator. The incorrect identification of     the CTM could lead to many complications. In certain patients such as obese or distorted neck     features would make the identification of CTM difficult. Ultrasound (US) has improved the     success rate of many anesthesia procedures .Its use has been described for identification of     neck structures however, this technique of localization has not been validated against the     gold standard which is the use of CT scan. The purpose of our study is to determine the     precision of identifying the CTM using the US versus the conventional finger palpation when     compared to the gold standard.   "
119189|NCT01725815|"     Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and     also challenges in effectively managing these health problems. There is an urgent need to     develop self-management strategies that allow persons with SMI to more effectively manage     their chronic medical illnesses.      In general populations, peer-led disease self-management interventions have been demonstrated     to be feasible, effective, scalable, and to lead to sustainable improvements in     self-management and health outcomes. With funding from an R34 intervention development grant     from NIMH, the study team has developed and piloted a modified version of the most widely     tested and used peer-led self management program, the Chronic Disease Self-Management Program     (CDSMP), for persons with serious mental illness. Two pilot tests of this intervention, the     Health and Recovery Peer (HARP) program, demonstrated that the program can be implemented     with high engagement, retention, and program fidelity, and can result in effect sizes across     a range of outcomes comparable to or greater than those seen in general medical populations.      This application proposes to conduct a fully-powered, multisite trial of the HARP program. A     total of 400 individuals with serious mental illnesses and one or more chronic medical     condition will be recruited from three diverse community mental health clinics in the Atlanta     metro region and randomized to the HARP program or usual care. For individuals in the HARP     program, two peer educators with SMI and one or more chronic medical condition will lead a     six-session, six-week manualized intervention, which helps participants become more effective     managers of their chronic illnesses. Follow-up interviews and chart reviews at 3 months, 6     months and one year will assess changes in clinical outcomes, improvement in generic and     disease-specific measures of illness self-management, and quality of care. During the final     phase of the study, a dissemination strategy building on the CDSMP training infrastructure     will allow program participants to lead HARP groups.      If successful, this study will establish the first fully peer-led, evidence-based     intervention for improving physical self-management in this vulnerable population.   "
119193|NCT01725763|"     Pulmonary hypertension (PH) is a life-threatening cardiovascular disease characterized by     pathological elevation of mean pulmonary arterial pressure (mPAP) >/= 25 mmHg at rest. mPAP <     20 mmHg is defined as normal, values in the range between 21-24 mmHg are described as     borderline PH diagnosed by right heart catheterization. Based on the etiology, PH is     assigned to 5 groups (WHO, Data Point, 2008), whereas classification of disease is an     important prognostic and therapy-deciding criterion.      Cardiac magnetic resonance tomography (CMR) provides a reliable technique to estimate     elevated mean pulmonary arterial pressure from period of existence of a vortical motion of     blood flow in the main pulmonary artery. Vortex can be visualized in 3-dimensional vector     field, particle trace and streamline representations and can be analysed with respect to     vortex related measures (geometry of center, vortex formation, vorticity, propagation     dynamics …). Furthermore T1-mapping and non-contrast enhanced lung perfusion/ventilation     scans represent promising techniques for PH characterization.      Aim of this explorative study is to 1. analyse PH-associated blood flow characteristics in     the heart and the surrounding great vessels with respect to the 5 groups of PH, and 2.     investigate the hemodynamic state of borderline PH compared to normal mPAP and manifest PH     by non-contrast CMR.   "
119194|NCT01725750|"     This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing     Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month     follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white     light treatment will report significant reductions in fatigue compared to individuals     receiving dim red light treatment for the same duration of time, and that these treatment     effects will be maintained one month after treatment completion.   "
119195|NCT01725737|"     Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity     Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current     medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant.     We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This     study will also help us to understand the mechanism of ADHD and give a way to develop new     drug and also a more possible way to treat ADHD children under 6 years old.   "
119196|NCT01725724|"     The purpose of this study is to compare the infection rate in patients receiving/not     receiving their own blood, collected during surgery, during and after orthopedic surgery.      The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative     infection.   "
119198|NCT01725698|"     This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4, BMP-2,     and implant in treating critical-sized bone defect.      In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone     will suffer a healing disturbance. In treating these conditions, the conventional method were     vascularised bone grafting and bone transport. But the existing methods of treatment have     many weaknesses Vascularized bone graft is a procedure with a high level of difficulty. Hence     not every orthopaedic surgeon were able to perform it. It also takes more operating time and     its failure rate is also quite high.      Meanwhile, external fixation which is applied with bone transport, was being often complained     by the patient in terms of cosmetic and psychologically.      According to diamond concept of bone healing, there are four main factors that influence the     bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive     factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical     component (implant). The potency of each component in fracture healing with/out bone defect     has been proved in many studies. The combined effect of these components is often studied as     well, but not in critical-sized bone defect.   "
119199|NCT01725685|"     This will be a randomized, double-blind, single-dose, three-period balanced crossover study     in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment     sequence consisting of each of the three treatments (FF 400 microgram (mcg), UMEC 500 mcg and     FF 400 mcg/UMEC 500 mcg), in three consecutive periods, with a wash-out period of 7 to 10     days between the periods.      The study will include a Screening period (28 days prior to first dose), Treatment period (3     single dose periods separated by two 7 to 10 days washout periods) and Follow-up period (7 to     14 days post last dose).      The pharmacokinetic (PK) and safety assessments will be performed during the study at fixed     timepoints.   "
119200|NCT01725672|"     This is a an open-label, randomized, single dose, four-way crossover, multi-stage study     enrolling 20 healthy adult male and female subjects per part. This study consists of two     separate parts (Part A and B) with each part comprising four treatment periods. Each subject     will participate in all four treatment periods per part; Subjects may not enrol in both Parts     A and B.      This study is being conducted to compare the pharmacokinetics (PK) of two extended release     fixed dose combinations (FDC) oral formulations of metformin and glimepiride at two doses,     500mg/1mg and 1000mg/2mg, with each FDC formulation to be administered orally as a single     dose and compared with the commercially available formulations of metformin extended release     (XR) (GLUCOPHAGE ™ Sustained Release [SR]) and glimepiride immediate release (IR) (AMARYL ™).      Part A of study will evaluate the bioavailability of a formulation comprising a film coated     tablet containing release controlling polymers; and Part B will evaluate the bioavailability     of a formulation comprising a tablet coated with release controlling polymers.      In each part there will be 4 treatment periods. During each period, subjects will be     randomized sequentially to receive a single dose of a reference treatment of 500 mg metformin     XR / 1 mg glimepiride IR; and a reference treatment of 1000 mg metformin XR / 2 mg     glimepiride IR; and an FDC tablet containing 500 mg metformin XR and 1 mg glimepiride XR; and     an FDC tablet containing 1000 mg metformin XR and 2 mg glimepiride XR.Serial PK sampling for     up to 36 hours and safety assessments will be performed. Each period will be separated by a     washout period of at least 5 days and a follow-up visit will occur 14 days after the last     dose of study drug.   "
119203|NCT01725633|"     This study is being done to examine the safety and feasibility of a supervised progressive     exercise program in women diagnosed with metastatic breast cancer. Previous research among     women with metastatic breast cancer has shown that some of the treatments commonly used in     this population may have an adverse impact on physical fitness levels leading to feelings of     fatigue and poor quality of life. Supervised exercise training has been shown to reduce some     of these side-effects in women with early-stage breast cancer receiving common cancer     treatments. However, it is not known if supervised exercise training is a safe and feasible     intervention in women with metastatic breast cancer. This study is designed to find out if     supervised exercise training is safe as the patients undergo treatments for metastatic breast     cancer.   "
119204|NCT01725620|"     To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator,     Enbrel® 25mg.   "
119205|NCT01725607|"     We designed a study to determine whether a single dose of dexmedetomidine or thoracic     epidural anesthesia combined with general anesthesia would provide hemodynamic stability,     reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep     quality in patients after thoracic surgery.   "
119206|NCT01725594|"     This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple     ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses     (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a     high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.   "
119207|NCT01725581|"     The purpose of this study is to show that a new assessment tool for pelvic examination is     valid and reliable.   "
119208|NCT01725568|"     The BioMonitor is an implantable cardiac monitor used to automatically detect and record     episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial     fibrillation. The study will be conducted to support regulatory approvals outside of Europe.     This BioMonitor Master study is designed to investigate the clinical efficacy and safety of     the BioMonitor.   "
119209|NCT01725555|"     This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect     of food on the bioavailability of AXL1717 including patients with advanced malignant tumors   "
119210|NCT01725542|"     Evaluation of efficacy and tolerance to a QUadruple therapy with Asunaprevir , Daclatasvir,     Ribavirin and pegylated Interferon alpha-2a, in HIV-HCV genotype 1 or 4 coinfected patients     previously null responders to a standard Pegylated Interferon -Ribavirin regimen.      The proportion of patients presenting cirrhosis (defined by a METAVIR F4 score on liver     biopsy and/or with hepatic impulse elastometry ≥ 15 kPa) will be limited to 50% of all of the     patients included   "
119211|NCT01725529|"     The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as     part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in     patients with genotype 1 Hepatitis C virus (HCV) infection.   "
119212|NCT01725516|"     The purpose of this study is to determine whether myofascial release technique are effective     in the treatment of low back pain due to lumbar disc herniation.   "
119213|NCT01725503|"     The goal of the present study is to quantify the rate of synthesis of creatine in healthy     controls and endurance trained subjects. In addition, the effect of oral creatine supplement     for seven days on creatine kinetics will be examined.      Ten healthy controls (age 20-35 years) and ten endurance trained subjects will be recruited     by advertisement. Endurance trained subjects will be recruited from health clubs. They will     be screened for absence of any chronic disease (history, physical examination, CBC, metabolic     and liver panel, urinalysis). A DEXA measurement will be done to quantify whole body skeletal     muscle mass.      For five (5) days prior to the study, they will be placed on a creatine-free (essentially     meat-free) diet. Dietary compliance will be ensured by repeated communication with the     subject, by nurse coordinator and the CRU Nutritionist. Subject will maintain daily record of     the food intake for validation. On the last day, i.e. 24 hours prior to the tracer study,     subject will collect the 24 hours urine sample and bring it to the CRU on the day of the     study.   "
119214|NCT01725490|"     Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon     and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients     to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs     (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and     duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and     cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide, which     is widely used for treating diabetes mellitus, has recently been suggested to have a     suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant     safety issues in long term use. The investigators devised a double-blind randomized     controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in     non-diabetic FAP patients.   "
119215|NCT01725477|"     1. Methylene blue in laparoscopy use for tubal patency assessment        2. Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and          fertility.        3. tubal washing after Methylene blue administration could be effective in pregnancy rate          after operation.   "
119216|NCT01725464|"     During early postoperative after lung resection surgery, patients without oxygen     supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask     or cannular. In this study the investigators want to the sudy the effect of oxygen     supplementation via oxygen cannular during the first 120 minutes after surgery   "
119217|NCT01725451|"     This study will evaluate the effect of deodorant and antiperspirant use and the presence of     underarm hair on the absorption of testosterone. Each participant in this study will receive     6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm.     There is a minimum one day washout period between each dose. This study will last     approximately 24 days not including screening. Screening is required within 30 days prior to     the start of the study.   "
119231|NCT01725269|"     The AIR001-CS05 study evaluated the safety and efficacy (effectiveness) of AIR001 over 16     weeks in subjects who have PAH. The purpose of the AIR001-CS06 study is to evaluate the     intermediate / long-term safety of AIR001 in subjects who have completed the AIR001-CS05     study. Assessments to evaluate the effectiveness of the study drug will include measurements     of exercise ability and evaluations of PAH disease symptoms.   "
119218|NCT01725438|"     The objective of this project is to develop a non-invasive prenatal diagnostic test for     trisomy 21 which is reliable, sensitive and cost-effective, and thus, offers an alternative     to the currently employed invasive diagnostic tests amniocentesis and chorionic villus     sampling.      Current prenatal screening methods (blood markers and ultrasound) for trisomy 21 (Down     syndrome) detect about 90 % of cases and have a false positive rate of > 90 %. The results of     these tests are expressed in risks for trisomy 21, the threshold being in France at 1/250.     Women exhibiting a higher risk are offered to undergo invasive diagnostic testing, either by     amniocentesis or chorionic villus sampling. However, these invasive diagnostic methods are     associated with a considerable risk of miscarriage (1-3 %), and thus underline the importance     to develop a safe and non-invasive prenatal diagnostic test for trisomy 21. The investigators     have planned to assess the clinical impact of a non-invasive prenatal method to detect     Trisomy 21 through genetic analysis of circulating trophoblastic cells.   "
119219|NCT01725425|"     The purpose of this study is to investigate whether different portion sizes will effect     overall mood.   "
119220|NCT01725412|"     Thiamine is a key component in the creation of physiologic anti-inflammatory mediators. Serum     thiamine stores have been found to be deficient in diabetic patients. Thiamine deficiency may     be a key pathological mechanism of inflammation that results in diabetic kidney and retinal     injury. The investigators hypothesize that the repletion of a patient's thiamine by oral     supplementation may result in reduced inflammation, and therefore reduced kidney injury.   "
119221|NCT01725399|"     Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery     and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a     medicine called ondansetron (Zofran), is in dire national shortage. Consequently,     non-pharmacological methods of prevention and treatment for post-operative nausea and     vomiting have increased import. Following emergence from general anesthesia, children often     request food and drink. There have been no studies to date that definitively determine the     optimal first food or drink choice for these children. This study proposes to randomize     children to either water or juice first intake following surgery. The investigators expect to     find that children who consume glucose are less likely to vomit than those who first receive     water.   "
119222|NCT01725386|"     This observational study will evaluate the routine clinical use and the safety and efficacy     of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible     participants will be followed for up to 24 months.   "
119223|NCT01725373|"     In patients with unprotected left main disease (ULMD), angioplasty is emerging as an     alternative technique. The investigators aimed to determine the rate of major cardiovascular     events in patients treated by angioplasty for ULMD in a real world registry.   "
119224|NCT01725360|"     Control of airway inflammation is the cornerstone of asthma management. The aim of the     present pilot study was to assess whether, and in which magnitude, a leukotriene receptor     antagonist (LTRA) added to a basic treatment of inhaled corticosteroids (ICS) + long-acting     betamimetics (LABA) might improve airway hyperresponsiveness and inflammation in     well-controlled patients with asthma.   "
119226|NCT01725334|"     Schizophrenia is a complex, challenging, and heterogeneous psychiatric condition, affecting     up to 0.5% of the population and responsible for nearly 2% of all Canadian health-care     expenditure. Much of the morbidity of the illness is related to its negative symptoms,     including amotivation, asociality, anhedonia and flattened emotional affect, which lead to     functional impairment and withdrawal from social and occupational domains. In contrast to     positive symptoms, such as hallucinations and delusions, there are currently no effective     treatments for negative symptoms, which experts recognize are largely responsible for the     long-term disability of a majority of patients with schizophrenia. Advances in neuroscience     have allowed a greater understanding of negative symptoms and have identified key structures     and circuits believed to generate and maintain them. Here, we propose the application of a     targeted therapy, deep brain stimulation, to alter the circuits driving negative symptoms.   "
119227|NCT01725321|"     Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the     missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in     the right side colon have been suggested to be the cause for interval cancer that developed     after a prior negative colonoscopy.      Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been     developed to improve colonic polyp detection. However, it remains controversial whether the     previous version of NBI helps to improve colonic polyp detection. The new generation     colonoscope is equipped with high definition and improved narrow band imaging (NBI) which     gives at least twice the viewable distance and contrast. The images obtained are far brighter     with better resolution than the previous version. It however remains to be determined whether     this enhanced imaging technique could help to improve colonic polyps detection.      Hypothesis:      The new generation NBI increases the detection rate of proximal serrated polyps and reduces     the missed rate of all colorectal polyps.      Aims:        -  To determine whether the new generation NBI improve the detection rate of proximal          serrated polyps.        -  To determine whether the new generation NBI improve the detection rate of all colorectal          adenoma and polyps.        -  To determine whether the new generation NBI reduce the miss rate of colorectal adenoma          and polyps.   "
119228|NCT01725308|"     In period I, the treatment effect of FK949E was compared with that of placebo in a blind     manner in bipolar disorder patients with major depressive episodes. In period II, the     long-term safety and efficacy of FK949E was evaluated.   "
119229|NCT01725295|"     Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have     found that our patients seem to benefit from a soft tissue physical therapy called     neurostructural integration therapy (NST). The purpose of this study was to compare NST to     hydrotherapy which is already used to manage fibromyalgia symptoms.   "
119232|NCT01725256|"     The purpose of this study is to evaluate the safety and effectiveness of an     investigational/experimental drug called AIR001.      To test the effectiveness, the study will evaluate how AIR001 affects the blood vessels in     the lungs and the function of the heart. This will be done by monitoring changes in Pulmonary     Vascular Resistance (PVR); from Baseline/Day 1 (start of study drug) to Week 16 of the study.     PVR measures the resistance to flow in the blood vessels of the lungs. The study will include     other assessments to evaluate the effect of the study drug on PAH, including measurements of     exercise ability and evaluations of PAH disease symptoms.   "
119233|NCT01725243|"     In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national     clinical guidelines on important women's health issues, recommended that a bolus of     carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of     oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to     oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the     recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be     used to achieve the same degree of uterine contractility with less side effects. So far, the     ideal dose to be used in cesarean sections for labouring women who have failure to progress     in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not     descending the birth canal) has not been determined. This study is designed to determine the     minimum carbetocin dose required during cesarean delivery for 'failure to progress' to     achieve the best effect.   "
119234|NCT01725230|"     A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered     alone or in combination with Fostamatinib.   "
119235|NCT01725217|"     To evaluate the immune response and safety following a single dose of Novartis Meningococcal     ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.   "
119236|NCT01725204|"     Patients with newly diagnosed CML have excellent outcomes with tyrosine kinase inhibitors     (TKI). However, a few patients will be cured with TKIs alone, and thus need continued     life-long treatment. Some patients achieve complete molecular remission (CMR), and this rate     is higher with second generation TKIs compared with imatinib. Some experience with drug     discontinuation in CMR has been derived from a few small studies, most notably the French     STIM study. Approximately 40 % of patients with a minimum of two years in MR4.5 (4.5 log     reduction in molecular response) can stop imatinib without relapse, indicating possible cure.     To increase the non-relapse rate is of major importance. To achieve a permanent cure     without stem cell transplantation is presently the most relevant goal of clinical studies in     CML.      The investigators hypothesize that to significantly increase cure rates in CML, therapy     should eradicate leukemic stem cells and/or induce or restore anti-CML immunity. Second     generation TKIs may have a more profound effect on the stem cell pool as compared to     imatinib. This is assessed in our current randomized study with a reduction in leukemic stem     cell burden as the primary endpoint (NordCML006). Interferon-alpha (IFN) has a prominent     immunomodulatory and antiproliferative mode of action, and has also activity in stem cells.     Pegylated IFN in combination with imatinib results in improved therapy responses as compared     to imatinib monotherapy. This advantage may translate into higher cure rates.      Dasatinib has a unique dual mechanism of action: it is the most potent of available TKIs and     induces immunological effects that are different from those of IFN. Both of these drugs may     have immunological adverse-effects when used as a monotherapy. However, immunological     adverse-effects may also be markers of anti-leukemia efficacy. A combination of dasatinib and     pegylated IFN (PegIFN) may have additive or synergistic effects and should be tested in a     clinical study.   "
119237|NCT01725191|"     This phase I trial studies the side effects and best dose of tivantinib in treating younger     patients with solid tumors that have returned after a period of improvement or have not     responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
119238|NCT01725178|"     Train The Brain is aimed at assessing the efficacy of cognitive and physical training in     slowing progression to dementia in patients diagnosed with mild cognitive impairment (MCI).   "
119240|NCT01725152|"     This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,     crossover study to investigate ganaxolone treatment in children with fragile x syndrome     (FXS). Up to 60 subjects (ages 6-17 yrs) will be randomized to receive either ganaxolone or     placebo for 6 weeks and then cross over to the opposite treatment for another 6 weeks. The     aim of the study is assess the safety, tolerability and efficacy of ganaxolone for treatment     of anxiety and attention in subjects with FXS. The hypothesis is that ganaxolone treatment     compared to placebo will improve anxiety and attention as measured by the several     neuropsychological and psychometric tests.   "
119241|NCT01725139|"     This is a dose escalation/dose finding, double-blind, placebo-controlled, parallel study of     GSK2126458 in subjects with IPF. The study is designed to explore a number of doses of     GSK2126458 for engagement of pharmacology after short term dosing. It is anticipated that     approximately 24 subjects will be enrolled in this study. Actual number of cohorts in this     study could vary up to a maximum of 6 cohorts (n=4/cohort; 3 on active and 1 on placebo).      Each cohort will consist of four subjects who will be randomised to receive GSK2126458 (three     subjects) or placebo (one subject) for approximately 8 days (7 to 10 days). On Day 1 they     will receive their first dose of GSK2126458 (or placebo) and safety, tolerability and PK/PD     in the blood will be measured for up to 8 hours post-dose. Subjects will then be discharged     from the site with study drug until the last day of dosing. They will also receive hand held     spirometers and instructions on action to be taken in case of deterioration in pulmonary     function or any other adverse events (AEs). On the last day of dosing they will return to the     site for a repeat of the Day 1 procedures.      A bronchoalveolar lavage (BAL) and [18F]-fluoro-deoxyglucose (FDG)- positron emission     tomography / computed tomography (PET/CT) scan will be conducted twice during the study;     once, at least 2 days before dosing commences and again during the course of the dosing     period.      After the final subject in each cohort has completed dosing, a dose escalation meeting will     take place. Safety and tolerability and PK data will be reviewed during this meeting and     decisions made may include but are not limited to: escalate the dose, decrease the dose or     repeat the same dose in the next cohort; stop the study.   "
119266|NCT01724814|"     Study Design:      Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with     Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1     diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes   "
122480|NCT01682785|"     Aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive     disorder and factors correlation.      Aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive     disorder and factors correlation.   "
119242|NCT01725126|"     This study is the first administration of GSK2890457 in humans. The study will be conducted     in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and     tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as     evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of     Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites)     will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2     diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of     Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up     periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD     in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening,     Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.   "
119243|NCT01725113|"     The purpose of this non-inferiority study is to compare the safety and effectiveness of a     mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol     in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO)     parathyroid hormone targets.   "
119244|NCT01725100|"     This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study     with incomplete wash-out in subjects with solid tumors to determine the relative     bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared     with standard reference formulation trametinib.      Approximately 18 subjects will be randomized to receive either a single dose of Treatment A     (standard target DMSO content [theoretical 11.3%] formulation of GSK1120212B) or a single     dose of Treatment B (lower DMSO Content [approximately 9.5%] formulation of GSK1120212B)     followed by a 7 day incomplete wash-out period, then a single dose of the other treatment.      Administration of the dose under fasted conditions in Periods 1 and 2 will be only on Day 1     followed by 7 days of serial blood sampling for PK analysis of plasma trametinib. Safety     assessments, including assessment of AEs, clinical laboratory (hematology and clinical     chemistry) and vital signs, will be made throughout the study.      After a subject completes the study, he or she may be eligible to enter study MEK114375, an     open-label rollover study of trametinib (no wash-out period or follow-up visit required) and     continue receiving trametinib. For those subjects who wish to discontinue or complete the     current study and choose not enter the rollover study, a follow-up visit should be performed     within 21 days after receiving the last dose of study treatment.   "
119245|NCT01725087|"     The purpose of this trial is to evaluate the safety and efficacy of once daily orally     administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with     moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days     screening period followed by a 2-week titration period and 12-week maintenance double-blind     treatment period and a 10-14 day safety follow up period. Patients who are eligible for the     double-blind treatment period will be randomized to one of the following treatment groups:     GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.   "
119246|NCT01725074|"     This randomized controlled trial (RCT) will examine a case management program for patients     suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The trail     consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3)     standard care. The main objectives are to evaluate how case management and social interaction     alone compared to standard medical care affect the primary and secondary outcomes: physical     health, quality of life, loneliness, depression, self-efficacy, outcome expectancies, social     support, health locus of control, lifestyle behavior, social network, vulnerability,     intention, severity, health worries and cognitive functions.   "
119247|NCT01725061|"     Acute lung injury (ALI) is an often deadly form of respiratory failure caused by     inflammation. The widespread injury to the lungs involves a build-up of fluid in the lungs     that results in damage to the lungs and a decreased ability of the lungs to function     properly. There is currently no specific treatment for ALI; and of the 200,000 cases reported     in the US yearly, about 40% will die.      Some patients may have other conditions that could change the risk of developing ALI. For     example, it has been reported that patients who have septic shock have a lower chance of     developing ALI if they also have diabetes mellitus (diabetes). Septic shock is a type of     infection that causes overwhelming inflammation to occur throughout the body; it increases     the chances that a person will develop ALI.      The reason diabetics are less likely to develop ALI is unclear and deserves further     investigation. The investigators believe that it may be explained by differences in the way     certain cells that are involved in inflammation function in the lungs. The investigators plan     on looking at the relationship between the wide-spread inflammation that occurs within the     bodies of diabetic and non-diabetic patients with an increased chance of developing ALI     [sepsis].      To study this relationship, we will identify patients who fit the requirements of the study.     The investigators will obtain blood samples and lung washings from these patients. The lung     washings will be obtained by injecting clean salt water into the lungs through a tube and     then pulling the water back out. When the sterile water is removed, some cells from the lungs     also are removed and they can then be used for further lab studies. Determining how diabetes     may change a patient's chance of developing ALI may uncover useful information that may help     prevent or treat ALI in all patients at risk.   "
119248|NCT01725048|"     This is a pilot study to test the hypothesis that the antidepressants mirtazapine and     citalopram are effective treatment for major depressive disorder (MDD) in cancer patients.   "
119249|NCT01725035|"     Nonalcoholic Fatty Liver Disease (NAFLD) is becoming the most common cause of liver disease     in pediatrics, but little is known about its pathophysiology in children. While studies in     obese adults with hepatic steatosis have described an increased hepatic de novo lipogenesis     (DNL) depending on the diet, there are no studies exploring the mechanisms by which excess     hepatic triglycerides increases in obese youths, thus explaining the accompanying     dyslipidemia and the metabolic syndrome. The central hypothesis of this study is that hepatic     conversion of carbohydrates to lipid (DNL) is enhanced and associated with accumulation of     excess liver fat, dyslipidemia and hepatic insulin resistance in obese youths with hepatic     steatosis. The overall goal is to examine whether hepatic DNL is increased in obese youths     with steatosis compared to matched controls without steatosis.      Hypotheses: Hepatic conversion of carbohydrates to lipid (DNL) is enhanced and is associated     with accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese     youths with hepatic steatosis.   "
119267|NCT01724801|"     EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this     clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase     Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with     EGFR-mutant non-small cell lung cancer.   "
122539|NCT01682018|"     The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves     (Zephyr) would reduce native lung overinflation in patients that underwent single lung     transplantation due to emphysema, and improve their well being and pulmonary function tests.   "
119250|NCT01725022|"     The primary goal with this study is to document whether patients can maintain their normal     bowel microbiota by staying at home compared to those who live at home but are treated in     clinic, and those who are treated in the hospital. In addition, the investigators would     predict that the quality of life will be higher for those patients treated at the medical     home compared to those that stay at the hospital. The investigators also predict that the     costs associated with this approach will be significantly lower compared to hospitalized     patients. Finally, the investigators propose that the treatment related morbidities and     mortality will not be different between the two groups.   "
119251|NCT01725009|"     To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute     intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male     subjects   "
119252|NCT01724996|"     To determine the significance of a simple bedside clinical test (chest wall tenderness) to     exclude myocardial ischemia in different demographic groups.   "
119253|NCT01724983|"     Ketamine may improve recovery from bariatric surgery.   "
119254|NCT01724970|"     Obese people pose specific problems as far as the management of airway during surgery. The     study aims to compare efficacy and safety of two LMA devices.   "
119255|NCT01724957|"     The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict     significance of SB ostial stenosis after main vessel stenting in coronary bifurcation     lesions.   "
119256|NCT01724944|"     The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian     cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.      Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic     lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications     rate), progression free interval, overall survival, recurrence pattern.   "
119257|NCT01724931|"     The purpose of this study is to determine whether aminopterin is effective in the treatment     of rheumatoid arthritis (RA).   "
119258|NCT01724918|"     The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a     new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram)     rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those     doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG     (electrocardiogram), a test which checks for problems with the electrical activity of the     heart.   "
119259|NCT01724905|"     Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed     those in the general population, consume energy dense diets, and perform very little physical     activity (PA). Overweight and obesity are independent risk factors for chronic disease such     as cancer, diabetes, hypertension, and cardiovascular disease in both the general population     and those with IDD.      The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged     meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and     vegetables (F/V) per week. The investigators will compare participants who use the SLDm with     participants who use a reduced energy and fat diet with meal plans, based off of the current     American Dietetic Association recommended car for weight reduction plan.   "
119321|NCT01724086|"     The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and     low-dose ritonavir, administered together with and without ribavirin and of TMC647055,     TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a     limited number of patients with chronic hepatitis C virus (HCV) infection.   "
119260|NCT01724892|"     Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK).     Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has     numerous serious complications, especially glaucoma. Loteprednol, a new generation of     corticosteroid has less potency than dexamethasone and was proposed to has less side effect     regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to     compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after     PRK and risk of glaucoma.   "
119261|NCT01724879|"     The current standard treatment approach for young patients with Positive Acute Lymphoblastic     Leukemia (Ph+ALL) is the combination of a chemotherapy protocol employing four to five     cytotoxic agents typically used for ALL together with imatinib. It is recommended to propose     allogeneic Standard Induction and Consolidation Therapy (SCT) to all eligible patients with a     suitable donor and to continue imatinib with or without additional therapy in patients not     undergoing SCT.      This protocol is a study for newly diagnosed Philadelphia chromosome positive acute     lymphoblastic leukemia in patients aged 18 to 55 years.      The objective of this strategy is to improve the overall results in the treatment of adult     ALL with the addition of specific molecules to the common chemotherapeutic schedule.   "
119262|NCT01724866|"     The purpose of this study is to assess the effect of test doses of HM10460A on the duration     of severe neutropenia (DSN) during Cycle 1 in patients with breast cancer who are candidates     for adjuvant or neoadjuvant chemotherapy.   "
119263|NCT01724853|"     The main objective of the study is the evaluation of the outcomes following treatment for TMC     OA using a set of variables covering all OMERACT categories as well as the dimensions of the     International Classification of Functioning, Disability and Health (ICF). Secondary aims are     the analysis of the determinants of patient satisfaction with the treatment result, the     evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ),     which has not yet been established in TMC OA patients, as well as the economic impact     associated with TMC OA.   "
119264|NCT01724840|"     Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the     use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and     successfully used in TMC OA surgery and therefore represents an acceptable alternative for     avoiding possible donor-site morbidity. However, there are no randomised controlled trials     (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared.     Only with an RCT design it is possible to gain evidence about the advantages of one treatment     method over another. The main objective of the study is the comparison between two surgical     techniques for TMC OA: The resection interposition suspension arthroplasty using a part of     the flexor carpi radialis tendon as interpositional material and using the GraftJacket as     interpositional material.   "
119265|NCT01724827|"     The main purpose of this trial is to determine which material, between ceramic and composite,     is best to manufacture dental inlays and onlays in the treatment of moderate dental substance     losses, generally due to dental caries. Restorations will be done using direct Computer     Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which     factors influence the success of these restorations.   "
119268|NCT01724788|"     Primary Objective:        -  To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral          formulation in patients with chronic renal failure undergoing peritoneal dialysis.      Secondary Objectives:        -  To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral          formulation and 250 mg IV formulation        -  To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special)          oral formulation and 250 mg IV formulation   "
119269|NCT01724775|"     In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in     which the same principle of TME in rectal cancer has been applied to the colon. More and more     surgeons pay attention to the rationality of this surgical approach. However, the clinical     application researches are still few, in particular the prospective controlled study is still     none. This clinical trial will compare the CME group and non-CME group to evaluate the     outcome and safety of CME for apply in clinic.   "
119270|NCT01724762|"     This study's general objective was to evaluate the efficacy of nursing orientation to reduce     the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific     objectives included: the development and validation of an informative manual concerning bed     bath; correlation of physiological variables (systolic and diastolic blood pressure and heart     and respiratory rate) with the patients' state anxiety; correlation of antecedent variables     (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety, depression,     prior hospitalization, prior experience with bed baths, the patients' preference for a female     or male professional to perform the bath, pain, fear, and embarrassment) with the patients'     state anxiety.   "
119271|NCT01724749|"     The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular     calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission     tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects     and subjects with cardiovascular disease.   "
119272|NCT01724736|"     This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie     beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the     Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones     (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and     satiety.   "
119273|NCT01724723|"     Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB     patients, especially in those with viral hepatitis. A previous study revealed the risk of     HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA level     than those with low HBV DNA level. Based on these findings, we thus hypothesize that the risk     of HATT in TB patients with high baseline serum HBV DNA level can be reduced by concomitant     use of anti-HBV agent. In this proposal, we will conduct a prospective randomized clinical     study to assess the reduction of HATT risk by using entecavir in TB patients with high     baseline serum HBV DNA level, and to evaluate the risk of other treatment-related adverse     events in two hospitals.   "
119530|NCT01721369|"     The SYNCAT study intention is to study the level of adherence of the centers in Cataluña tu     the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that     following them can have in the prognosis of these patients.   "
119274|NCT01724710|"     Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is     major reason leading to chronic wound healing.      The investigators's previous animal experiments have confirmed that OLED can promote burn     wound healing and fibroblast proliferation in normal Wistar rat.      In order to find the time point and dosage of the effective light therapy. The investigators     further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast     proliferation mechanisms.      Expect clinical application of light therapy in the future is more accurate and effective.   "
119275|NCT01724697|"     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related     hepatitis can developed into liver cirrhosis.      Liver transplantation is the only available life saving treatment for patients with end stage     liver disease. However, lack of donors, surgical complications, rejection, and high cost are     serious problems.      stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte;     Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common     source of SCs for clinical applications.Previous study showed that bone marrow derived stem     cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver     failure and contribute to liver regeneration. In this study, the patients with HBV-related     liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to     evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.   "
119276|NCT01724684|"     Recent studies have demonstrated the promising potential that telehealth has in management of     chronic disease. For COPD patients, implementation of telehealth reduced readmissions,     emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of     delivering healthcare to remote, resource-deprived areas is not lacking in evidence of     benefit; however, the situation about its more widespread use for monitoring purposes is much     less clear. To date, most of the studies dealing with telehealth in COPD were conducted in     countries covering vast territories. Therefore, it needs to be investigated whether     telehealth conveys similar advantages for COPD patients in a small island country.   "
119277|NCT01724671|"     To compare the time to pathogen eradication, and the relationship to the time to clinical     improvement, between ceftaroline and case-matched vancomycin treated controls in the     treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus     aureus (MRSA).   "
119278|NCT01724658|"     Additional testosterone undecanoate can improve female sexual function in postmenopausal     women which one aspects of quality of life. The dose adjustment can reduce incidence of     adverse effects and low cost of treatment with effective outcome.   "
119279|NCT01724645|"     This trial is being conducted to look for following changes when Korean traditional diets is     taken in subjects with hypertension and type 2 diabetes:      To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.      To assess the controlling blood pressure and heart rate.      To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High     Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.      To evaluate the influence on Gamma-Glutamyl Transpeptidase.      To evaluate the influence on Cardiovascular risk factor.      To evaluate the influence on valsava score, breathing score and upright score.   "
119280|NCT01724632|"     The purpose of this study is to compare three methods of delivering behavioral weight loss     treatment.Participants are randomly assigned to one of three 18-month weight loss treatments     (group, individual, or smartphone treatment). Participants who are assigned to group     treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6     months, and then monthly for the final 6 months. Participants who are assigned to individual     treatment will attend one-on-one sessions with a weight loss counselor every month for 18     months. Participants who are assigned to smartphone treatment will use a smartphone to learn     and practice weight loss skills. They will also attend one-on-one sessions with a weight loss     counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and     18 months.   "
119281|NCT01724619|"     Prostate cancer represents a significant health problem in the United States. This year     179,000 men in the United States will be diagnosed with prostate carcinoma and approximately     25% of them will die of the disease. In addition, the incidence and mortality of prostate     carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA)     levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless,     there is a significant false negative and false positive diagnosis since PSA levels elevate     in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications     and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels     within the normal range, thus confounding the diagnosis based on the PSA screening test.     Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided     prostate biopsy are logistically difficult and insensitive. These are further complicated by     equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or     normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer     related structures at a cellular level would enhance our understanding of the pathophysiology     of prostate cancer and would contribute to the detection, localization and quantification of     the disease and its metastases. This information will be invaluable in selecting the     appropriate treatment regimen.      This study will test the utility of [F-18]FMDHT to image prostate cancer and will evaluate if     this radiotracer can differentiate primary prostate cancer in the prostate gland from normal     prostate gland itself. More specifically, we will study the distribution kinetics of     [F-18]FMDHT in normal healthy humans and in patients with prostate cancer.      As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an     outside laboratory (ILS, Inc.) and the results of that study are attached as Appendix A.      Based on our and others data, we hypothesize that:        1. [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood          flow pattern and will clear rapidly from tissues with no AR.        2. [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR.        3. [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions          compared to surrounding normal prostate.      In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human'     biodistribution study in subjects with and without prostate cancer.   "
119282|NCT01724606|"     Sorafenib is a new type of anti-cancer drug. It belongs to a new class of medications known     as tyrosine kinase inhibitors. Sorafenib is thought to work against cancer in many ways. It     helps decrease blood supply to the tumor. It also blocks some proteins that help the tumor     cells to grow. Sorafenib is approved by the Food and Drug administration (FDA) for treatment     for other cancers like liver and kidney cancer. Sorafenib has also been studied in the     treatment of breast cancer that has spread but is not specifically approved for the treatment     of breast cancer. It has been studied both as a single agent and also in combination with     other anti-cancer therapies for breast cancer. In laboratory models and in some patients with     other cancers, sorafenib has been studied in tumors in the brain.      In this study, sorafenib will be given together with whole brain radiation therapy (WBRT).     Overall this research study is designed to answer 2 main questions:        1. What dose of sorafenib should be used together with WBRT?        2. What are the side effects of sorafenib and WBRT when given together?   "
119283|NCT01724593|"     Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and     preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is     associated with increased mortality and length of stay, and negatively impacts long-term     functional outcomes and quality of life in affected patients and their caregivers. While     delayed mobilization adversely affects clinical outcomes, early rehabilitation in the     critically ill adult population is safe, feasible, cost effective, results in more ventilator     free-days and better functional outcomes at hospital discharge. In contrast, there is a     paucity of this research in pediatrics. Our research suggests that immobilization is common     in critically ill children, and rehabilitation is delayed particularly in the sickest     children who are arguably at highest risk of morbidity. It is unclear however, whether     delayed rehabilitation leads to adverse outcomes in critically ill children, as has been     demonstrated in adults. Our objectives of this study are to evaluate if immobilization and     delayed rehabilitation negatively impacts short-term clinical outcomes and the time to     functional recovery in critically ill children. The investigators hypothesize that the     following factors may influence functional recovery and morbidity in critically ill children:        -  Pre-morbid condition        -  Age        -  Time-to-initiation of acute rehabilitation        -  Critical illness disease severity   "
119284|NCT01724580|"     The Requesting Physician/Investigator contacts Lilly when, based on their medical opinion, a     patient meets the criteria for inclusion in the expanded access program.   "
119285|NCT01724567|"     The purpose of the study is to make a head-to-head comparison of weight loss and interval     training as methods of secondary prevention in overweight patients with ischemic heart     disease.   "
119286|NCT01724554|"     The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal     Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or     Proliferative Diabetic Retinopathy (PDR).   "
119287|NCT01724528|"     The purpose of this study is to determine whether febuxostat is superior to allopurinol in     the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at     intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo     chemotherapy   "
119288|NCT01724515|"     The purpose of this study is determine if you have too much fat in your body that it will     decrease the conversion of food energy into energy that your body can use.   "
119289|NCT01724502|"     The purpose of this study is to determine whether insulin resistance is accompanied by     exercise resistance. Investigators will use mass spectrometry and proteomics analysis to     test the hypothesis is that a bout of exercise that increases mitochondrial protein abundance     in lean, healthy individuals is less effective in insulin resistant patients.   "
119398|NCT01723085|"     Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian     surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other     surgeries. We seek to investigate the hormone variations before and after an open myomectomy.      Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels     in a few months   "
119399|NCT01723072|"     This study will assess the impact of omalizumab on the quality of life improvement when added     to the standard therapy in refractory patients suffering from chronic spontaneous urticaria     and angioedema.   "
119290|NCT01724489|"     Obesity is an important risk factor for osteoporosis and fractures. With the growing     prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this     population is of importance to public health. Growth hormone (GH) is a critical mediator of     bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an     important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of     bone loss in obesity. The development of novel imaging techniques provides an opportunity to     investigate the effects of GH on skeletal structure and strength, which will provide insights     into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone     loss in obesity may help identify new treatment targets for this important complication. The     investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal     health.   "
119292|NCT01724463|"     Thousands of children die from Sepsis following routine infections. Many of these deaths can     be prevented with earlier recognition and focused management. No tools are currently     available to recognize the signs of early sepsis in children. The investigators have     developed a electronic health record-based tool that will recognize children with sepsis     early and trigger an alert to their hospital caregivers. The caregivers will be prompted to     launch a focused management bundle that can stabilize these children, prevent further     deterioration and reduce their chances of sepsis related complications and death. The     proposed study will test the validity and effectiveness of this electronic tool in reducing     sepsis mortality rates.   "
119293|NCT01724450|"     The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after     chemotherapy in breast cancer.   "
119294|NCT01724437|"     The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein     isolation using a standard approach compared to application of an additional acute procedural     endpoint of unexcitability along the ablation line.   "
119295|NCT01724424|"     Antioxidant therapy targeted at mitochondria has the potential to reduce inflammation,     mitochondrial damage and organ dysfunction in sepsis. Melatonin accumulates in mitochondria     and both it and its metabolites have potent antioxidant and anti-inflammatory activity,     preventing organ dysfunction in a rat model of sepsis. The investigators propose a study in     healthy volunteers to assess the tolerability and pharmacokinetics of exogenous melatonin and     its major metabolites and to relate these doses to ex vivo anti-inflammatory and antioxidant     activities. Groups of healthy subjects will receive increasing sequential doses of oral     melatonin in an open label dose escalation study. Ex vivo inflammatory responses, oxidative     stress and mitochondrial function at concentrations of melatonin identified in the dose     escalation study will be determined following exposure of whole blood to an inflammatory     insult. This will provide crucial information to inform a subsequent phase II clinical trial     of melatonin in patients with sepsis.   "
119337|NCT01723878|"     This observational study will evaluate the patterns of disease progression in patients with     locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating     mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed     for up to 12 months after progression of disease.   "
119296|NCT01724411|"     The proposed study will address the effect of developed novel food products through     processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability     and gut health using in vivo studies and validating new in vivo approaches.      Specifically in this protocol we will address, in a short human intervention study the effect     of a potentially satiating product on appetite, appetite biomarkers, particularly the     influence on gut microbiota, tolerance and safety of the products in healthy obese and     overweight volunteers in free living conditions.   "
119297|NCT01724398|"     Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells.     Although liver transplantation provides an option to cure patients suffering with LF, lack of     donors, postoperative complications, especially rejection, and high cost limit its     application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs)     the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured     liver, and effectively rescue experimental liver failure and contribute to liver     regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it     helps the liver regeneration and functional recovery and make UC-MSC differentiation into     hepatocyte like cells, and exert immunomodulatory function. In this study, safety and     efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined     with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be     evaluated.   "
119298|NCT01724385|"     To evaluate the efficacy of intravitreal bevacizumab injections for treatment of     proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after     previous full panretinal photocoagulation (PRP).   "
119299|NCT01724372|"     This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the     second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk     for developing psychosis.      Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated     and will lead to greater improvement in symptoms at the end of 6 months of treatment.   "
119300|NCT01724359|"     The purpose of this study is to evaluate efficacy, safety and tolerability of flexible,     once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from     Argentina and Colombia that previously failed treatment with other antipsychotic agents.   "
119301|NCT01724346|"     An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia     (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (PCI-32765     versus Chlorambucil)   "
119326|NCT01724021|"     This multi-center, open-label, randomized study will evaluate the participant preference with     subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in     participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's     lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV)     on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4,     followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive     MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8     cycles of standard chemotherapy (according to local country practice) with 8 cycles of     MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.   "
119302|NCT01724333|"     Assessment of oral and dental problems is seldom routine in clinical oncology, despite the     potential negative impact of these problems on nutritional status, social function and     quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues     to improve symptom management has been requested. The present study will be conducted on     behalf of and with support from the European Organisation for Research and Treatment of     Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step,     in the development of an international, symptom specific questionnaire module, focusing on     oral and dental problems in relation to cancer and its treatment. Phase I-III of this     stepwise development process was conducted from 2008 to 2011, as an international     collaboration and conducted according to the guidelines for module development set forth by     the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field     testing and validation study as described in this project description.      The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item     scales (pain/discomfort, xerostomia, eating and information) and three single items related     to use of dentures and future worries. The aim of the present study is to conduct phase IV;     an international field study to confirm the psychometric properties of the QLQ-OH17   "
119303|NCT01724320|"     The purpose of this study is to determine the recommended dose (RD) for further phase II     studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced     solid tumors   "
119304|NCT01724307|"     The purpose of this study is to evaluate if stimulating the nerve involved with airway     constriction, while undergoing procedures that are known to cause asthma exacerbations,     decreases the level of asthma attack experienced.   "
119305|NCT01724294|"     This multicenter, observational study will evaluate the correlation between clinical and     biological factors and International Prognostic Index (IPI) as prognostic factors in patients     with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan     (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment     according to standard of care and local guidelines will be followed for the duration of     treatment (approximately 8 months) and during 1 year of follow-up.   "
119306|NCT01724281|"     The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd     trimester of normal width and asymetry of lateral brain ventricles   "
119307|NCT01724268|"     Compare the efficacy of adding small doses of prednisolone (10 mg) daily to the efficacy of     adding one of the available anti TNF in the treatment of methotrexate inadequate responder     rheumatoid arthritis patient.      Hypothesis:      Methotrexate + Prednisolone vs. Methotrexate + anti TNF   "
119348|NCT01723735|"     Primary Objective:      To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either     alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol     (LDL-C).      Secondary Objectives:        -  To assess the pharmacodynamic profile of alirocumab administered either alone or on top          of ezetimibe or fenofibrate, based on other lipid parameters.        -  To assess the pharmacokinetic profile of alirocumab administered either alone or on top          of ezetimibe or fenofibrate.   "
119308|NCT01724255|"     The medical literature does not provide sufficient information or recommendation regarding     the optimal time to remove the staples and the bandage after a cesarean section. The goal of     this study is to compare 5 groups of patients:        1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1        2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4        3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1        4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7        5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7      Since there is no definite protocol for staple and dressing removal, we will adapt the above     protocol each for a 3-4 month period of time. Patients will be contacted to either return for     a follow up visit or to answer a telephone survey.   "
119309|NCT01724242|"     There does not appear to be a consensus regarding the treatment of vaginal dryness in women     who have a contraindication to the use of estrogen products. DHEA, when used locally, may     improve the symptoms of vaginal dryness due to its chemical properties.   "
119310|NCT01724229|"     The purpose of this evaluation is to observe the performance of two (2) different skin care     treatment protocols on the skin:      #1 Kendall™ Body Wash & Shampoo in combination with the Moisture Barrier Cream; or #2     Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.      The scientific evidence supports using these types of skin care products to keep the skin     healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are     preferred over soap and water and can be applied on all areas of the skin. The Moisture     Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The     Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch,     and ring worm to relieve itching, soreness, and irritation.   "
119311|NCT01724216|"     The purpose of the study is to collect in vivo human image data to demonstrate neurological     magnetic resonance imaging (MRI) of subjects using short pulse sequences.   "
119312|NCT01724203|"     The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week     probiotic supplementation on the incidence and duration of infectious episodes in infants     aged 6 to 12 months.   "
119313|NCT01724190|"     The purpose of this study is to determine if supplementation with Vitamin D in children and     adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter     the honeymoon period.   "
119314|NCT01724177|"     To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma     (ATL) who have previously received chemotherapy for ATL.   "
119315|NCT01724164|"     The purpose of this proposal is 1) to compare the relative effects of the robotic     rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare     the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the     RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will     potentially influence the functional outcomes after interventions.   "
119327|NCT01724008|"     A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site     study in subjects with at least two sensitive teeth to compare the efficacy of a test     dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity   "
119328|NCT01723995|"     This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in     mothers with nipple trauma during breastfeeding, compared to a control group.   "
119329|NCT01723982|"     This trial investigates the effects of FE 200440 compared to placebo on implantation rate in     women undergoing IVF/ICSI treatment   "
125841|NCT01637896|"     The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting     balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent     implantation in terms of restenosis   "
119316|NCT01724151|"     The proposes of this study are        1. To understand the physical activities of patients with cognitive impairment in Taiwan          and construct the validity and reliability of the physical activity questionnaire and          actigram in this population.        2. To understand the relation between brain structure (brain tractography and resting state          functional MRI) and cognitive and physical functions of patients with cognitive          impairment, the capability of activity and social engagement (including quality of          life).        3. To understand the efficacy of exercise on the brain structure (brain tractography and          resting state functional MRI), cognitive and physical functions, the capability of          activity and social engagement (including quality of life) of the patients with          cognitive impairment.      The study aims to establish the data base of physical activity of patients with cognitive     impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on     physical function, physical activity and social engagements to provide an optimized design of     exercise program for patients with cognitive impairment in the future.   "
119317|NCT01724138|"     To characterize the PK of deferasirox in pediatric β-thalassemia major patients aged from 2     to less than 6 years old, when administrated with a fixed starting dose of 20 mg/kg/day.   "
119318|NCT01724125|"     Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by     shifting the ownership and locus of health records from being scattered across multiple     providers to an approach that is longitudinal and patient-centered. Given the complex health     needs and the fragmentation of care for persons with serious mental illnesses, these     individuals could derive particular benefit from a PHR. However, there are currently no     established PHRs developed for use in this population.      In order to fill this gap, the investigators propose to develop, test, and disseminate a     Personal Health Record for persons with serious mental illnesses and one or more comorbid     medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health     record which was developed in partnership with medical consumers and is in wide use in a     number of communities in the United States and abroad.   "
119319|NCT01724112|"     This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg)     once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.   "
119320|NCT01724099|"     The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a     superior reduction compared to those taking the placebo.   "
123359|NCT01671319|"     The purpose of this study is to determine the feasibility of giving standard TC chemotherapy     on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side     effects.   "
119322|NCT01724073|"     A food-to-food fortification strategy has been designed based on traditional foods of Burkina     Faso to fight against micronutrient deficiencies in young children. Leafy vegetable sauces     were formulated to improve their micronutrient contents and bioavailability. This efficacy     study was designed to assess the effects of the regular consumption (one meal per day, 6 days     per week) of these leafy-vegetable sauces enriched or not with liver on iron, zinc and     vitamin A status, growth and morbidity of young children from poor urban districts of     Ouagadougou. The study is conducted by IRD and IRSAT-DTA and will last 6 months. 432 12-15     month-old children will be recruited and randomly assigned to one of the four following arms:     three intervention groups, the two first receiving leafy vegetable sauce, the third one     receiving one meal made of the fortified Misola gruel. In these three arms, blood samples     will be collected at the beginning and at the end of the study. The fourth arm is an external     control group and will not receive any food. In this fourth arm, blood samples will be     collected only at the end of the study. Biochemical indicators of micronutrient status will     be determined, and anthropometric data will be collected in all children. Morbidity will also     be assessed in children of intervention groups.   "
119323|NCT01724060|"     Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden     both for patients and health systems alike. The surgical and medical treatments available for     these conditions have improved significantly in the last two decades. The investigators do     not however know how these treatments compare to each other and how they act in the body to     cause weight loss and diabetes improvements. The studies of this experiment are complementary     to each other. They aim to answer related questions and will allow us to study how these     treatments work and eventually develop safer and more effective therapies for obesity and     diabetes.   "
119324|NCT01724047|"     The primary goal of this study is to identify efficacious and cost effective intervention     strategies that can improve academic and psychological outcomes for children with ASD, and     can be feasibly be implemented at fidelity by school personnel in under served elementary     schools. Two simultaneous interventions will occur.      In intervention 1, students with ASD in inclusion classrooms will be randomized to the     Playground Intervention or a waitlist control group. In the Playground Intervention,     UCLA/ROC/UPENN staff will work with school personals (teachers, paraprofessionals) to     increase peer engagement on the yard.      In intervention 2, students in special day classes will be randomized to the 'Schedule Tools     Activities Transitions' Intervention (STAT) or wait-list control. In the STAT Intervention,     UCLA/ROC/UPENN staff will work with teachers to implement behavioral strategies in the     classrooms.      In both interventions, the conditions are: 1) Immediate treatment, where the training will     begin immediately after baseline measures are completed. 2) Wait-list treatment, where the     training will begin the follow school year.   "
119325|NCT01724034|"     Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean adult     patients. In this randomized trial, standardized lung ultrasound will be performed daily     asssociated with standardized interventions aiming to decrease the total time in mechanical     ventilation.   "
119343|NCT01723800|"     This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given     together with carboplatin and pemetrexed disodium in treating patients with stage IV     non-small cell lung cancer. PI3K inhibitor BKM120 and pemetrexed disodium may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120,     carboplatin, and pemetrexed disodium together may kill more tumor cells   "
119330|NCT01723969|"     The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a     European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this     screening platform is to provide quick access to new drugs to patients by offering a new     structure for clinical trials.      Currently some of the most challenging clinical questions arise from the molecular     sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways     in the patients.      A major problem for trials in this personalized medicine is that the low frequency of the     different mutations requires a high effort for screening and identifying the patients.      The EORTC CRC screening platform will hopefully offer a feasible and efficient way to     characterize the patients on the molecular basis of their tumors and allow to offer them     rapid and preferential participation in clinical studies with new drugs targeted to their     specific pathway alterations.   "
119331|NCT01723956|"     To compare the efficacy of cryotherapy and large loop excision of the transformation zone     (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia     (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.      Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV     positive women in South Africa   "
119332|NCT01723943|"     This randomized clinical trial studies educational counseling in improving communication and     quality of life in spouses and breast cancer patients. An outpatient education and behavior     skills training program may help spouses and patients with breast cancer communicate better     and improve quality of life. It is not yet known whether educational counseling is more     effective than an educational booklet in improving communication and quality of life.   "
119333|NCT01723930|"     Get a better understanding of the pathophysiological processes of acute respiratory failure     following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.      Demonstrate that there is a relationship between increased transpulmonary gradients of     inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance     on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery     under cardiopulmonary bypass.   "
119334|NCT01723917|"     The purpose of this study is to evaluate the safety and efficacy of a soy based dietary     supplement (phytoSERM) for hot flashes and age associated memory loss.   "
119335|NCT01723904|"     This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low     doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)     who have insufficient response to L-dopa and low doses dopamine receptor agonists.   "
119336|NCT01723891|"     Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01     after oral administration for one day in healthy male volunteer.   "
119338|NCT01723865|"     This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients     with heart failure having an ICD-CRT implanted.      Study purpose The purpose of this study is to test the hypothesis that the monitoring of     specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical     course of patients with heart failure.      Study design This is a prospective observational study, comparing clinical course of patients     with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This     study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring     system (with or without weight and pressure external sensors) or followed by conventional     ambulatory visits.      Primary endpoints The primary endpoint of this study is to document no superiority of     unplanned hospital access for cardiac reasons (included access to the emergency units ) or     death for cardiovascular causes in remote monitoring group (with or without weight and     pressure external sensors) compared to conventional follow-up (usual care group).   "
119339|NCT01723852|"     The study is a randomized, controlled, double blinded study evaluating the effect of     recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years     of age, on growth, bone development, neurologic and cognitive development, frequence of     infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2     years of age.   "
119340|NCT01723839|"     In previously-untreated subjects with CLL, fludarabine and rituximab with or without     cyclophosphamide (FR or FCR) produces complete responses (CR) of 40-80%. The major     complication of FCR has been grade 3/4 neutropenia which was reduced using a lower dose of     fludarabine and cyclophosphamide (FCR-Lite) The objective of this study is to evaluate the     minimal residual disease (MRD) complete response rate (using the 2008 IWCLL guidelines) after     4 cycles of FCR-Lite plus lenalidomide in subjects with previously untreated CLL.     Lenalidomide is active in frontline treatment of CLL as well as in patients with refractory     disease. MRD has been demonstrated to be a sensitive surrogate marker for progression-free     survival. If patients are MRD negative complete responders (CR) they will stop at 4 cycles of     FCR-Lite followed by the lenalidomide consolidation/maintenance arm of the study. If they     have a MRD positive CR or partial response (PR) they will continue with 2 additional cycles     of FCR-Lite plus lenalidomide followed by lenalidomide consolidation/maintenance. They will     be re-tested for MRD after the 6th cycle of FCR-Lite and after 6 and 12 months of     lenalidomide monotherapy If they have no response (NR) or progressive disease (PD) following     4 cycles of FCR-Lite plus lenalidomide they will be removed from the study.   "
119341|NCT01723826|"     This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term     safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's     disease who have participated in and completed the treatment period of the Phase II Study     ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study     ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on     study treatment is 144 weeks.   "
119342|NCT01723813|"     The purpose of this study is to determine whether the intravenous and/or GM-CT-01     administration can correct Tumor Infiltrating Lymphocytes (TIL) anergy and induce a more     efficient and long-lasting anti-tumoral immune response following peptide vaccination.   "
119344|NCT01723787|"     Infantile spasms (IIS), a characteristic epilepsy syndrome of infancy with often catastrophic     developmental consequences, is known in some patients to have many different genetic,     metabolic and structural etiologies. However, for most patients IIS is the only presenting     clinical feature and the specific cause is unknown. Only two FDA approved pharmacologic     treatments for IIS exist, Adrenocorticotropic hormone (ACTH) and vigabatrin. While vigabatrin     may be the treatment of choice for Tuberous Sclerosis as a cause for IS, ACTH is the     treatment of choice for all others. Unfortunately, a substantial number of patients may still     not respond to ACTH and there is no a priori way that suggests which patients may be     responders. This has led to the following key questions:      Can novel genetic analyses determine known genetic causes of IS with greater efficiency (more     timely and cost-effective)? Can novel genetic analyses determine previously unknown disease     modifying genes that predispose individuals to develop IS? Can novel genetic analyses     elaborate genes and gene polymorphisms that favor ACTH responsiveness? Do these polymorphisms     suggest strategies to improve ACTH responsiveness?   "
119345|NCT01723774|"     A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early     stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate     whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic     complete response rate when compared to the historical control of single agent aromatase     inhibitors, 2) result in fewer patients with on therapy Ki67>10% compared to historical     control.   "
119346|NCT01723761|"     It is a clinical, observational study to evaluate the correlations among arrhythmias,     climatic variables and air pollution in patients with pacemaker and implantable defibrillator     (ICD), followed by remote monitoring.      Purpose of the Study: The purpose of this study is to test the hypothesis that changes in     climatic variables, such as temperature, pressure and humidity, and changes of particulate     matter <10µ (PM10), particulate matter <2.5µ (PM2.5), ozone (O3), carbon monoxide (CO),     sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of     supraventricular and ventricular arrhythmias.      Objectives: The aim of this study is to determine whether changes in variables conditions     affect the electrical stability of the myocardium in patients with pacemakers and ICDs.      Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber pacemaker,     ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology centers of the     Veneto region will be included.   "
119347|NCT01723748|"     The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often     results in a concomitant suppression of the insulin secretion, which might lead to clinically     significant glucose intolerance. Secondly, the traditional evaluation of disease activity by     measuring circulating levels of GH and total IGF-I is not reliable enough      Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:        -  Glucose intolerance despite normalized insulin sensitivity        -  Modified peripheral GH activity in peripheral target organs assessed on molecular          endpoints   "
119391|NCT01723176|"     Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent     to that of echocardiography technicians/cardiologists for the purpose of determining etiology     (reason) of cardiopulmonary failure.   "
119349|NCT01723722|"     This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs     for the difference in the length of treatment. This is a randomized, open-label comparison of     phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium     (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.   "
119350|NCT01723709|"     The goal of this study is to enroll 1000 participants with a history of Multiple Sclerosis     into the MURDOCK Study (Duke IRB Pro00011196) as well as into the Multiple Sclerosis Cohort     study (Duke IRB Pro00023791). All 1000 participants will answer a 4-page questionnaire     administered by a trained study coordinator which is designed to collect information on the     participant's diagnosis of Multiple Sclerosis. The goal of the study is to seek genetic     explanations for response to treatment, progression of the disease, and biomarker validation.   "
119351|NCT01723696|"     Vitamin C supplementation (500 mg per day) given to pregnant women who can not quit smoking     will improve the pulmonary function tests in their offspring measured at 3 months of age.   "
119352|NCT01723683|"     There is a reducing incidence of pneumothorax, PIE and the combined outcome of death or BPD     since the development of Surfactant therapy. A policy of intubation with surfactant     administration and mechanical ventilation has become a standard therapy of infants at high     risk of RDS. However, initial stabilization with CPAP and, if necessary, given rescue     surfactant therapy has remained the standard therapy for preterm infants. Evidence reveals     similar results with regard to mortality and neonatal morbidity between the above two     strategies. The investigators intend to develop a method of minimally invasive surfactant     therapy followed by early CPAP (MISTCPAP) in preterm Infants with high risk of RDS for     improving the outcomes and reducing the incidence of BPD.   "
119353|NCT01723670|"     To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to     2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive     impairment.   "
119354|NCT01723657|"     The AML-03 regimen investigates the addition of G-CSF priming to both induction and     consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines     risk-stratification based on biological characterization also the AML-03 trial incorporates     novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ in vivo     purging in autografts, extends unrelated volunteers donors for allotransplants in high-risk     patients, and introduces reduced intensity conditioning in patients with elder age (more than     50 years old).      The aims of these modifications are to analyse eficacy and toxicity of this induction and     consolidation therapy and to analyse the disease free survival in patients who achieved     complete response following a risk adjusted therapy.   "
119386|NCT01723241|"     This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when     applied to the skin of healthy volunteers.   "
119355|NCT01723644|"     CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial     including adult patients admitted in the emergency department with community-acquired     pneumonia. The objective of this clinical trial is to compare two strategies: clinical     reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with     community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is     systematically started in the emergency department. The continuation, the discontinuation or     the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and     Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is     diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and     to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to     evaluate the possibility to stop the current antibiotherapy based on criteria for clinical     stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart     rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg,     Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm,     initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship     based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the     clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all     persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm     can be overruled by pre-specified criteria, e.g. in patients with immediately     life-threatening disease. If the algorithm is overruled and antibiotics are given, an early     discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on     PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are     reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs     defined above.   "
119356|NCT01723631|"     The objective of this project is to characterize the response TRAP positive patients with     Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in     order to develop a second time as a diagnostic tool in this disease. We plan to analyze the     response TRAP over a hundred patients with various clinical stages SEP (relapsing,     progressive forms) and compared to healthy controls,   "
119357|NCT01723618|"     The purpose of the study is to determine the plasma levels of CRD007 in patients with     abdominal aortic aneurysms after the administration of single doses of tablets containing 10,     25 and 40 mg CRD007.   "
119358|NCT01723605|"     Two types of uterine repair described during cesarean section, the investigators will try to     compare between the two techniques.   "
119359|NCT01723592|"     The aim of this study is the improvement of the vaginal flora by at least two grades of the     Nugent scale after application of oral probiotics.   "
119360|NCT01723579|"     This study will investigate the efficacy and safety of the monophasic      combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in      healthy fertile Indian women.   "
119362|NCT01723553|"     The study is designed to assess the demographic, clinical and imaging associations with the     presence of microbleeds in atypical Alzheimer's disease. The primary hypothesis is that     cognitive and functional performance will be poorer in atypical Alzheimer's subjects with     microbleeds compared to those without microbleeds.   "
119363|NCT01723540|"     Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and     therefore we investigate here the contributions of UsD in early recovery.   "
119392|NCT01723163|"     The primary goal of the current study is to evaluate the effectiveness of a combined     tele-health and contingency management (CM) intervention that investigators are calling     Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a     two-group design in which 300 Veteran smokers will be randomized to either:      ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines     guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for     access to nicotine replacement (NRT), and intensive behavioral therapy through mobile     contingency management.      TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide     controls for therapist, medication, time and attention effects. The tele-health intervention     provides the same guideline based cognitive-behavioral smoking cessation telephone counseling     (TC), and tele-medicine clinic for access to NRT as in the ART intervention.   "
119364|NCT01723527|"     More Americans are arrested for drug offenses than for any other crime. In 2009, over 294,000     arrests were made for possession of cocaine or heroin. Incarceration does not address the     root problems and is frequently followed by relapse and re-arrest after release. In the case     of opiate-dependent adults arrested for possession of heroin, one potentially effective     alternative is to divert offenders to methadone maintenance treatment (MMT) as an alternative     to adjudication of their case. MMT is an effective treatment for heroin dependence, and     appears very effective for criminal offenders. However, cocaine use is common in MMT     patients, including those with recent criminal justice involvement, and MMT alone is     ineffective in addressing cocaine use. Continued cocaine use carries a substantial health     burden and necessarily entails continued criminal activity. Thus, treatment for diverted     opiate-dependent offenders should be designed to address cocaine use as well as opiate use. A     Stage 1 Behavior Therapy Development project is planned over 2 years to adapt, manualize and     pilot test the Therapeutic Workplace intervention for adults charged with heroin possession     and offered diversion to methadone maintenance treatment as an alternative to adjudication of     their case. The Therapeutic Workplace is a novel, employment-based contingency management     intervention that has been very effective in promoting cocaine abstinence in adults who use     cocaine persistently during methadone treatment. In the Therapeutic Workplace, participants     are hired in a model workplace and required to provide drug-free urine samples to work and to     earn maximum pay. Once we develop and manualize the adapted version of the Therapeutic     Workplace for adults arrested for heroin possession, a pilot test will be conducted.     Individuals identified by the State Attorney's office as candidates for diversion will be     assessed for study eligibility. Given the high rates of injection drug use and     injection-related transmission of HIV in Baltimore, this study will be restricted to     injection drug users to evaluate the potential utility of this intervention in reducing HIV     risk. Eligible individuals will be offered methadone maintenance in lieu of prosecution and     will be required to remain in methadone treatment for 90 days. All participants will receive     standard MMT, independent of whether they decide to participate in the pilot study. After     beginning MMT, participants will be invited to enroll in the pilot study and randomly     assigned to two study groups. Participants assigned to the Usual Care Diversion group will     receive the standard MMT. Participants assigned to the Therapeutic Workplace Enhanced     Diversion group will receive the standard MMT and the Therapeutic Workplace intervention. The     data from this pilot study will serve as the foundation for a full-scaled randomized     controlled trial. Overall, the Therapeutic Workplace could serve as a novel and ideal     intervention for many heroin dependent adults involved in the criminal justice system. The     use of MMT in lieu of adjudication in combination with the Therapeutic Workplace could     increase drug abstinence and employment and decrease HIV risk and criminal activity in this     refractory high-risk population.   "
119365|NCT01723514|"     The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated     in healthy subjects and migraine patients. As part of the secondary objectives, this study     will be conducted to characterize the pharmacokinetic (PK) profile of AMG 334 after multiple     SC doses in healthy subjects and migraine patients, as well as to characterize the effect of     AMG 334 on the capsaicin induced increase in dermal blood flow after multiple SC doses in     healthy subjects and migraine patients.   "
119366|NCT01723501|"     Purpose of this study is determine if skin application of chlorhexidine at birth would reduce     infection in infants weighing <1500 g at birth.   "
119367|NCT01723488|"     [F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the     human brain.   "
119368|NCT01723475|"     This is the first study where BAY2010112 is given to humans. Patients with castration     resistant prostate cancer will be treated. Every patient will receive drug treatment, there     is no placebo group. Patients will receive different dosages of BAY2010112 to determine the     safety, tolerability and maximum tolerated dose (MTD) of BAY2010112.      The study will also assess the pharmacokinetics and the clinical efficacy of BAY2010112.      BAY2010112 will be given daily as subcutaneous injection or as continuous intravenous     infusion. Treatment will be stopped if the tumor continues to grow, if side effects, which     the patient cannot tolerate, occur or if the patient decides to exit treatment.   "
119369|NCT01723462|"     Clinical pharmacy has played a role in Emergency Departments (ED). The presence of     pharmacists have been shown to reduce medication errors and improve the medication history     taken at admission. In Denmark a recent study revealed that clinical pharmacists identified     medication problems in 25% of all admission to the ED, of which 47 % were considered to be     serious.      However, the pharmacist recommendations are of little value if they are not acknowledged or     followed by the physicians.      The aim of the present study was to analyze how often and under which circumstances the     physicians made use of pharmaceutical recommendations in an ED with a mixed patient     population with special attention to those recommendations, which were of significant or     disastrous importance.   "
119370|NCT01723449|"     In Demark acutely admitted patients are supposed to stay in the Emergency Department (ED) bed     ward if the anticipated duration of stay is less than 48 hours.      However, it is not a trivial matter to estimate duration of stay for emergency patients. a     number of factors affect this, eg. social background, disease, hospital organisation.      The aim of this study is to analyse whom are the best among the health staff to predict the     length of stay: ED nurses, admitting doctors og the specialist, and to analyse if a number of     variables can be used to improve the prediction.   "
119371|NCT01723436|"     Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The     result is decision fatigue, in which subsequent decisions are altered toward the status quo.     Surrogates are at risk for decision fatigue yet it has not been studied. We propose a     randomized study in the outpatient setting in surrogates and patients at high risk for     needing to make complex decisions, in an effort to determine the impact of decision fatigue     on surrogate self-control and subsequent choices.   "
119372|NCT01723423|"     The MROC Study seeks to evaluate and compare from the patient's point of view the leading     options for breast reconstruction after mastectomy. This study will help patients,     physicians, payers and policy makers better understand the various surgeries available for     breast reconstruction. Although many women choose reconstruction, the number of options as     well as their pros and cons can make decision making difficult and stressful. From this     research, we hope to learn more about what works best for patients undergoing these     operations.   "
119373|NCT01723410|"     UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with     internet access, are not pregnant, planning to become pregnant, or currently breastfeeding     (if female), to participate in a study investigating whether real-world experiences alter the     brain and body. This study takes place over an eight week period and involves providing the     names of 8 close friends or family members, completing a neuroimaging session, providing     blood and saliva (for genetic analysis), and a 6-week period in which participants login     twice a week to complete online questionnaires. Compensation is up to $210 for those who     complete all aspects of the study. Please email realworld.ucla@gmail.com for more     information.   "
119374|NCT01723397|"     The objectives of this protocol are:        1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal          challenge with antigen, and        2. to show that inhibition of the immediate response to nasal challenge with antigen by          Nasaleze inhibits subsequent inflammatory events.   "
119409|NCT01722942|"     The primary objective is to compare the efficacy of the treatment using implantable     cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in     the primary prevention of all-cause mortality in high-risk patients with Chagas     cardiomyopathy and non-sustained ventricular tachycardia (NSVT).   "
119375|NCT01723384|"     Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using     and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing     relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is     inexpensive and has few toxicities but the standard daily regimen for naltrexone is     problematic as patients forget to take the medication. Given the challenges in daily dosing,     alternate regimen schedules have been proposed to increase efficacy and expand the population     that may benefit from this pharmacologic agent. One approach is intermittent targeted     administration of naltrexone, whereby individuals take the medication as-needed in     anticipation of substance use or during periods of craving. Administration of naltrexone     prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone     has shown efficacy in reducing heavy alcohol use. However, there have been no studies     assessing intermittent targeted dosing of naltrexone among methamphetamine-using and     binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those     who abuse more than one substance are urgently needed. The aims of this study are to     determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among     non-dependent methamphetamine-using and binge-drinking MSM.   "
119376|NCT01723371|"     This study will determine the safety and feasibility of using a β-blocker (in this case     carvedilol) in the treatment of pediatric patients with Left Heart Failure (LHF) in children     with Pulmonary Arterial Hypertension (PAH). Carvedilol affects the nervous system, the same     system that is highly activated in response to stress in patients with PAH. Each patient is     administered a dosage of carvedilol, according to their weight. This dosage is increased     incrementally over the span of the study, if the patient responds well to the drug. The study     will determine whether the potential adverse side effects of carvedilol outweigh the possible     positive results in reducing LHF. The hypothesis of this study predicts that carvedilol will     have positive effects in treating LHF, similar to their use in treatment of Right Heart     Failure (RHF). This is a single-centered pilot study. Each patient will be studied for     approximately 31 weeks.   "
119377|NCT01723358|"     The goal of this study is to obtain data that well help inform the feasibility and design of     a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES)     technique in improving the swallowing function of young infants presenting with severe     dysphagia.   "
119387|NCT01723228|"     This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on,     parallel-group study to evaluate the effect of rasagiline on cognitive function in adults     with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).   "
119400|NCT01723059|"     Traditionally, H pylori infection has been treated with conventional triple therapy. This     includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14     days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy     which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of     clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We     hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe     will not be predictive of resistance patterns and response rates in the United States.   "
119378|NCT01723345|"     Percutaneous coronary intervention (PCI) has become the most common form of coronary     revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks     including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It     is estimated that approximately 25% of patients undergoing PCI have significant     postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations     and approximately 50% of patients have significant post-procedural troponin elevations.     Initially, it was felt these elevations were simple enzyme leaks with no long-term     implications.      Now, several studies have demonstrated that periprocedural infarction is associated with     short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment     with antiplatelets such as aspirin and clopidogrel play an important role in reducing     cardiovascular events (CV events) following PCI.      Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve     response to aspirin and clopidogrel in low-response patients.      This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement     [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on short-term     (within 30 days) and long-term (after one year) major adverse cardiac events (MACE) in     patients undergoing elective PCI. Eighty patients planed to do elective PCI will be     categorized into two groups. The first group will be received standard regimen for PCI     (aspirin, clopidogrel, and heparin) and the second group will be treated with standard     regimen in addition to 3 gram omega 3 (12 hours before PCI). The main end point of the trial     was short-term (within 30-days) and long-term (after one year) incidence of MACE (death,     myocardial infarction, or unplanned revascularization).   "
119379|NCT01723332|"     Transition is the planned movement of teens with chronic conditions from child-centered to     adult-oriented healthcare. National bodies have published detailed guidelines about the     importance of helping teens move to adult healthcare. However, there is no research regarding     how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is     urgently needed. Therefore, the aim of this program is to develop research evidence that will     better prepare health care providers to improve how they can help adolescents with     transition.      This project will determine whether a nurse-led transition intervention program is better at     preparing teens with CHD to independently manage their medical care, compared to the care     that is currently provided. The most important finding of this study will be whether or not     these teens subsequently attend the adult cardiology clinic that specializes in CHD problems,     and the timing of when they attend.      Hypothesis: A transition intervention in combination with usual care, improved time to first     Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.   "
119380|NCT01723319|"     Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil     deep brain TMS in subjects with ADHD.      Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients     will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.      Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The     treatment administrator and the study personnel and patients will be masked to the treatment     being administrated.      The study group will receive active dTMS treatment and the control group will receive an     inactive, sham treatment   "
119410|NCT01722929|"     The aim of this study is to assess the role of skin sensors in obtaining reliable and     accurate serial measurements of skin parameters in the context of cutaneous skin wound     healing.   "
119411|NCT01722916|"     The purpose of this study is to find how much hyaluronidase should be used when receiving     injections of fillers.   "
148922|NCT01334814|"     The proposed study is a randomized, single blind trial of intermittent versus continuous     stimulation among essential tremor (ET) patients with a chronic history of continuous     stimulation.   "
119381|NCT01723306|"     T cells can penetrate virtually every biologic space and have the power to dispose of normal     or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous     remis-sions of cancer. However, T cells are easily tolerized to self or tumor antigens and     immune surveillance has manifestly failed in every cancer that is clinically apparent. It     is the goal of these studies to supply the specificities and affinities to patient T cells     without regard for their endogenous T cell receptor repertoire, directed by     antibody-defined recognition to kill malignant cells based on their expression of antigen. We     will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to     yield designer T cells from normal patient cells. This extends the approach of Anderson,     Rosenberg and co-workers to introduce or augment expression of genes in patients' T cells in     a therapeutic setting.      Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified     T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and     cytotoxicity, the hallmarks of an effective, self-sustaining immune response. It therefore     becomes of paramount interest to extend these studies to a human system of widespread     clinical relevance to explore the clinical potential of this new technology. The target     antigen for these studies is carcinoembryonic antigen (CEA) which is predominantly expressed     on tumors of the colon and rectum, breast, pancreas and other sites.   "
119382|NCT01723293|"     The purpose of this study was to examine the behavior of the fetal heart rate in response to     different intensities of acute maternal exercise in training and non-training pregnant women   "
119383|NCT01723280|"     Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and     after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis     at a long-term follow-up.      Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of     surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI     trial, found no difference in frequency of surgical site infection. In fact, long-term     mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80%     oxygen, and this appeared to be statistically significant in patients undergoing cancer     surgery, but not in non-cancer patients.      At this point, no convincing mechanism explains the observed increased mortality after     hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.      Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the     frequency of patients with a subsequent, new or recurrent, cancer.   "
119384|NCT01723267|"     Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte     maturation and subsequent egg collection is largely based on follicle size. An accurate     assessment of follicle size and appropriate timing of HCG result in retrieval of more mature     oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the     capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset,     identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute     dimensions. These measurements include the largest diameters in three orthogonal planes, the     mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter     (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of     this automated technique of follicle measurement vs. standard 2D technology on the timing of     oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D     assessment will increase the rate of mature oocyte collection, and eventually will improve     other treatment outcomes such as fertilization rate.   "
119385|NCT01723254|"     The purpose of this study is to assess the safety and tolerability of different doses of     PF-06444753 and PF-06444752 in subjects with allergic rhinitis.   "
119388|NCT01723215|"     Military deployment to combat zones involves exposure to trauma at a higher than average rate     and therefore presents a unique opportunity to study predisposing factors to posttraumatic     stress reactions and test strategies designed to prevent and ameliorate posttraumatic     symptoms. Decades of scientific research on the origins of resilience and vulnerability to     combat-related posttraumatic stress symptoms revealed various predisposing and protective     factors. All these factors however, offer limited opportunity for systematic pre-deployment     prevention efforts. Considering the magnitude of psychological adjustment difficulties     encountered by combat personnel in deployment and the limited access to existing     evidence-based therapies for PTSD, the development and testing of a novel evidence-based and     theory-driven prevention protocol for these problems is of considerable significance. The     current study translates cognitive-neuroscience knowledge and attention bias modification     research into a novel computerized training tool that could be easily delivered to soldiers     during different stages of the deployment cycle. If proved efficacious in reducing risk for     posttraumatic symptoms ABMT could be integrated into the Army's resilience training program.     Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers.     We will assess attention bias and symptoms before deployment, will randomly assign soldiers     to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training.     Following 6 months of deployment to combat zone symptoms will be assessed again.   "
119389|NCT01723202|"     This randomized phase II trial studies how well dabrafenib works with or without trametinib     in treating patients with recurrent thyroid cancer. Dabrafenib and trametinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet     known whether dabrafenib is more effective when given with or without trametinib in treating     thyroid cancer   "
119390|NCT01723189|"     40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of     stroke show a respiratory pattern characterized by central apnoeas and/or periodic breathing.      Clinical studies conducted in patients with hearth failure and central apnoeas have     demonstrated the pathogenetic central role of hypersensitivity of central and peripheral     chemoreceptors in association with baroreflex hypersensitivity, expression of hyperactivity     of sympathetic nervous system.      The joint study of chemoreflexes and baroreflexes in patients with central apneas during the     acute and subacute phase of ischemic stroke represents, to our knowledge, a novelty in     literature, that should supply useful elements to clarify the pathogenesis and the clinical     and prognostic significance of these disorders.      Investigators expect a difference in the analysis of the baroreflexes and chemoreflexes in     patients with ischemic stroke/transient ischemic attack (TIA) and central apnoeas than     patients with ischemic stroke not accompanied by respiratory problems and compared with     healthy controls.   "
119393|NCT01723150|"     Background: Klebsiella pneumoniae liver abscess is the most common etiology of liver abscess     in Singapore and much of Asia, and its incidence is increasing. Current management includes     prolonged intravenous antibiotic therapy, but there is limited evidence to guide oral     conversion. The implicated K1/K2 capsule strain of Klebsiella pneumoniae is almost     universally susceptible to ciprofloxacin, an antibiotic with high oral bioavailability. Our     primary aim is to compare the efficacy of early (<1 week) step-down to oral antibiotics, to     continuing 4 weeks of intravenous antibiotics, in patients with Klebsiella liver abscess.      Methods/Design: The study is designed as a multi-centre randomised open-label active     comparator-controlled non-inferiority trial, with a non-inferiority margin of 12%. Eligible     participants will be inpatients over the age of 21 with a CT or ultrasound scan suggestive of     a liver abscess, and Klebsiella pneumoniae isolated from abscess fluid or blood.     Randomisation into intervention or active control arms will be performed with a 1:1     allocation ratio. Participants randomised to the active control arm will receive IV     ceftriaxone 2 grams daily to complete a total of 4 weeks of IV antibiotics. Participants     randomised to the intervention arm will be immediately converted to oral ciprofloxacin 750mg     twice daily. At week 4, all participants will have abdominal imaging and be assessed for     clinical response (CRP <20 mg/l, absence of fever, plus scan showing that the maximal     diameter of the abscess has reduced). If criteria are met, antibiotics are stopped; if not,     oral antibiotics are continued, with reassessment for clinical response fortnightly. If     criteria for clinical response are met by week 12, the primary endpoint of clinical cure is     met. A cost analysis will be performed to assess the cost saving of early conversion to oral     antibiotics, and a quality-of-life analysis will be performed to assess if treatment with     oral antibiotics is less burdensome than prolonged IV antibiotics.      Discussion: Our results would help inform local and international practice guidelines     regarding the optimal antibiotic management of Klebsiella liver abscess. A finding of     non-inferiority may translate to the wider adoption of a more cost-effective strategy that     reduces hospital length of stay and improves patient-centered outcomes and satisfaction.   "
119394|NCT01723137|"     Patient reported pain, stress, and anxiety measures have been found to be inter-related, but     it is not known if they are all associated with receiving opiate medications. The objective     of this study is to determine if patients' degree of reported pain, stress, or anxiety is     associated with receiving opiate pain medications in the emergency department or at     discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are     eligible to participate in the study. Consenting patients complete Visual Analog Scales     describing their perceived pain, stress, and anxiety from enrollment until discharge.     Demographic data and administration of pain medication is also recorded. Visual Analog Scale     scores among patients who received an opioid pain medicine in the emergency department and at     discharge will be compared to those who did not.   "
119395|NCT01723124|"     The purpose of this research is to evaluate whether repeating a screening Molecular Breast     Imaging (MBI) study two years after an initial screening MBI study further improves breast     cancer detection in women with dense breast tissue.   "
119396|NCT01723111|"     -  Dialysis modality may influence the oxidative stress and proinflammatory cytokines in          ESRD patients.        -  Dialysis modality may affect hepcidin        -  Dialysis modality may influence iron and ESA requirements.   "
119402|NCT01723033|"     Comparison of the neurophysiological response of OCD and PTSD patients (both considered     anxiety syndromes) in error processing. The patients will perform three computerized tasks     while a net of electrodes (for EEG measurement) will be placed on their head. This data will     then be compared to a previously collected healthy control sample.   "
119403|NCT01723020|"     First in human, open-label, sequential dose escalation and expansion study of AMG 232 in     subjects with advanced solid tumors or multiple myeloma   "
119404|NCT01723007|"     The study was designed to answer the primary question: the consumption of one apple three     times daily between meals reduces serum levels of cholesterol above 240 mg/dL in overweight     women? The second and important hypothesis was designed for evaluate the reduction in body     weight by intakes of fruits. Therefore, the increased consumption of apples could displace     the consumption of other foods and promoting satiety and input significant reduction in body     weight compared to other fruit (Pear) of similar nutritional composition or food (cookies)     made from oats with fiber and total calories similar to those observed in these fruits. To     demonstrate the effectiveness of these supplements we used a clinical trial with three arms     (apple, pear and oatmeal cookies).   "
119405|NCT01722994|"     Some Dermatologists prefer absorbable suture to non-absorbable suture in the closure of punch     biopsy sites. The reason these are often preferred is because patients do not have to pay for     another visit to get the suture material removed. Also patients are not inconvenienced into     returning to the office for suture removal1. However, the absorbable suture material     currently used by most Dermatologists is very expensive.      In order to evaluate ways to reduce costs for patients, we will compare a less expensive     suture material (chromic gut) with one of the absorbable suture materials currently used in     clinical practice (PDS).      Patients who are eligible and choose to participate in the study will undergo a punch biopsy     and a suture will be used to close the skin. The type of suture received by the patient will     be randomized, like the flip of a coin. Group A will receive PDS and Group B will receive     chromic gut suture.      After one weeks time, the patient will return to clinic and their dermatologist will evaluate     the biopsy site for redness, wound infection, wound opening, and scar formation. The patients     will be given a questionnaire evaluating their satisfaction with the cosmetic outcome and any     pain caused by the suture materials. If the suture came out before the visit, the patient     will be asked to report on what day the suture fell out. The patients will return two more     times over the next two weeks to receive the same questionnaire and evaluation by their     dermatologist.   "
119406|NCT01722981|"     Percutaneous tracheostomy is routinely performed in most intensive care units in the     world.Several studies have shown that the procedure is safe and economically efficient in     comparison to open surgical operation in the operating room.      In our institution as in a number of institutions in the country, it is acceptable to perform     the operation by placing the tube on a high position near the vocal cords by direct     laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by     palpation of the neck.      Using technological aids, such as direct sonography and bronchoscopy in real time may     significantly reduce the rate of complications as a result of performing percutaneous     tracheostomy.      So far, no systematic comparison has been made among the three methods.   "
119407|NCT01722968|"     To explore molecular biomarkers and/or gene expression signatures that predict response to     bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative     metastatic breast cancer (MBC).   "
119408|NCT01722955|"     The aim of the study is to compare effect of pre-warmed intravenous fluids on the early     outcomes in ambulatory patients undergoing monitored anesthesia care.   "
119698|NCT01719159|"     This is a is a small scale open phase two interventional study to assess long-term     stabilising effects of on neurological symptoms by regular intrathecal administered     monoclonal antibodies in progressive multiple sclerosis.   "
119412|NCT01722903|"     Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.     About 90% of CRC related deaths are due to metastatic spread—mostly to the liver and lungs.     With adequate multidisciplinary patient selection, CRC liver and lung metastasectomy     significantly improves survival and offers the best chance for a cure. However, patients with     limited lung or liver metastases are clinically underserved and poorly scientifically     studied. The individual indication for resection and the decision making for adjuvant     systemic therapies remains a challenge. More sensitive techniques to detect occult disease     are needed for metastatic CRC (mCRC) patients, and perioperative analysis of circulating     tumor cells (CTCs) may provide an outstanding opportunity to develop such innovative methods.     We hypothesize that CTCs are enriched during CRC liver and/or lung metastasectomy, and that     they can be isolated and characterized in an attempt to identify novel therapeutic targets.      CTCs are believed to be causing metastasis and may provide a non-invasive alternative to     organ biopsies for the detection, characterization and monitoring of solid cancers. CTC     numbers have been shown to be a strong predictor of Progression Free Survival and Overall     Survival for mCRC patients. The CellSearch system (Veridex LLC, Ratinas, NJ, USA) currently     is the only FDA approved test for the evaluation of CTC numbers in metastatic breast,     prostate and colorectal cancer. However, the rarity of CTCs in the blood leads to limited     capture efficiency and the CellSearch system fixes cells, preventing further molecular     characterization of CTCs by functional assays and primary cell culture. In this protocol the     CellSearch system will be compared to a new technology, called the Flexible Micro Spring     Array (FMSA) device, developed by Dr. Zheng, Department of Bioengineering, Penn State     University, University Park. This novel approach enables size-exclusion based filtration for     viable CTC enrichment. The FMSA device is inexpensive, works rapidly, and retains viable CTCs     for further biological study. Using both the CellSearch system and the FMSA device, we will     determine the kinetics of CTC shedding into circulation, develop an effective system for     isolation, enumeration, and further enrichment CTCs, and use this system to find     characteristics of different CTC populations.   "
119413|NCT01722890|"     Primary Objective:      The primary aim of the study is:      1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict     Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with     HER2-positive locally advanced or metastatic breast cancer.      Secondary Objective:      The secondary aims of the study are:        1. To perform a comprehensive exploration of the molecular and cytogenetic characteristics          of DCR patients to identify any possible correlation between the tumour's biological and          cytogenetic characteristics and the degree of clinical response to trastuzumab;        2. To produce data in preparation for further translational studies on HER2-positive breast          cancer.   "
119414|NCT01722877|"     Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads     to improved overall results compared to balloon angioplasty alone. However, scar tissue     development can occur within the stent, a process called restenosis. Treatment of these     in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue     is frequently seen. Several methods have been proposed to treat in-stent restenosis in the     lower leg arteries but mixed results have been noted. In this study we hypothesize that     simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can     lead to a high rate of acute procedural success with low intraprocedural complications and an     acceptable recurrence rate of restenosis at 6-month follow-up.   "
119415|NCT01722864|"     A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or     moderate to severe chronic low back pain.   "
119416|NCT01722851|"     To identify a panel of circulating miRNA markers which could help identify those breast     cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy,     and indeed serve as an overall prognostic factor and stratify patients into risk categories     which would further guide their management. Similarly, the investigators aim to identify a     panel of circulating miRNA markers which could monitor patient's response to chemotherapy and     hormonal therapies. Ideally a suitable panel of markers would show significant changes in     expression level in good-responders whilst little or no change would be observed in miRNA     expression in non-responders.   "
119417|NCT01722838|"     B-ME is a research intervention study designed to address the needs of African American men     who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is     to decrease HIV risk behaviors among African American MSM using an intervention developed by     and for African American MSM.      The hypothesis guiding this study is: that participants who complete B-ME intervention will     report greater reductions in sexual risk behaviors than the standard of care comparison     group.   "
119418|NCT01722825|"     The main purpose of this study is to evaluate the safety and side effects of LY2157299 in     Japanese participants with advanced cancer or cancer that has spread to other parts of the     body.   "
119419|NCT01722812|"     The purpose of this exploratory study is to investigate the clinical efficacy of cromoglicate     cream compared to cream vehicle in the treatment of itch in psoriasis   "
119420|NCT01722799|"     Significant lesions in small coronary arteries are frequently found (35%-50%) in patients     with coronary artery disease. Independently of the type of coronary angioplasty the     restenosis and the need for repeat revascularization remains the main limitation,     representing a challenging problem even in the DES (drug eluting stent) era. Recently has     been developed drug eluting balloons (DEBs), which have been successfully tested in small     series on in-stent restenosis, but few evidence is available in the context of small vessels     disease.      The current study has been designed to know, in one hand, the clinical efficacy of the Drug     elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the     cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY)     in patients with de novo lesions in small vessels.   "
119421|NCT01722786|"     Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as     Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need     urgent interventions/operations that cannot wait are included in this registry, or during     emergency operations.   "
119422|NCT01722773|"     The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic     obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded     variable effects on survival, quality of life and dyspnea. The investigators hypothesized     that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.   "
119447|NCT01722448|"     The investigators want to find out whether a choline supplement can protect muscle health in     young men with very common genetic vulnerabilities. Men, who respond to a brief, but intense     set of arm exercise and have a common genetic profile, will be asked to use a choline     supplement for three weeks and a placebo for three weeks. Before the begin of the     supplementation study and after 3 and 6 weeks the investigators will test response to the     exercise challenge and ask that all consumed foods are recorded.   "
119423|NCT01722760|"     Children born prematurely are of greater risk of developing chronic lung disease     (Bronchopulmonary Dysplasia).      With an increase in the amount of premature children, we expect an increasing number of     children with BPD.      Today we do not have many ways of predicting or treating this condition, and the children are     usually in hospital for several months after birth. Many are dismissed with home oxygen.     Children with BPD are typically often re-submitted to hospital with respiratory disease the     first couple of years, and some of them have problems throughout childhood and into     adulthood.      Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary     Disease (COPD).      The condition as well as the treatment (steroids), are associated with great risk of adverse     effects as Cerebral Palsy, blindness, deafness and mental retardation.      The investigators wish to find a safe way to identify the children in greater risk of     developing BPD, who could therefore benefit from a more intensive treatment.An early     diagnosis would increase the possibility of predicting the prognosis.      Other studies have proven a connection between both low vitamin A and D and high exhaled     nitrogen oxide (NO) with lung disease.      With this trial the investigators wish to make a reference material for NO and vitamins A and     D in infants admitted to the neonatal department at two hospitals in Denmark, both with and     without treatment with nasal Continuous Positive Airway Pressure.      The investigators furthermore wish to describe an eventual connection between BPD and these     factors by examining a large group of children on 7 specific occasions within the first two     months of life and at a one year follow up.   "
119424|NCT01722747|"     BRIEF SUMMARY: This study, which is closed to enrollment, is testing the efficacy of a     tobacco-control intervention geared towards school teachers in Bihar, India. This cluster     randomized trial aims to promote tobacco use cessation among teachers and increase tobacco     policy adoption in 72 Bihar schools. Teachers are the focus of the study because as role     models for youth and key opinion leaders related to community norms, they represent an     important group for tobacco control. Teachers in Bihar also have reported high rates of     tobacco use. According to the Global School Personnel Survey conducted in 2006, 39% of     teachers in the eastern region of India (which includes Bihar) use some form of tobacco,     compared to the national average of 29%. This study aims to reduce these numbers through     discussion groups with teachers, individual cessation counseling, educational materials, and     a tobacco policy workgroup in each intervention school. This study is a collaboration between     US researchers and researchers at the Healis-Sekhsaria Institute for Public Health, Mumbai     India.   "
125842|NCT01637883|"     To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal     tube cuff for postoperative sore throat.   "
119426|NCT01722721|"     physicians in the Emergency Department spend their time on interviewing and examining     patients, file documentation, communication with colleagues about the patients.      Introduction of IT technology aims to reduce the administrative workload. However it is the     impression that more and more time are used behind the PC rather than at the side of the     patient.      The aim of this study is to describe how the time is distributed between different task for     an ED physician, and to analyse whether there are differences in time distribution if the     physician is working in the outpatient area versus admission area of the ED.   "
119427|NCT01722708|"     Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk     pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated.     Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The     purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the     treatment of abnormal vaginal flora in high risk pregnancies. For this purpose, pregnant     women who are considered high risk for preterm labor and were diagnosed with abnormal vaginal     flora will be randomly treated either with clindamycin or metronidazole. Eradication of the     abnormal flora and adverse effects will be monitored and compared   "
119428|NCT01722695|"     The purpose of the study is to show equivalent performance of the Revaclear dialyzer when     compared to a dialyzer with larger membrane surface area.      Study design: open, randomized, cross-over, multicentric, controlled prospective      Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on     patient needs      Patients/sample size: 30 adult chronic hemodialysis patients      Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions)     with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.      Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of     urea, phosphate, creatinine and ß2-microglobulin; albumin loss      Primary variable: dialysis dose Kt/V urea      Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and     ß2-microglobulin      Safety variable: albumin loss, blood count   "
119429|NCT01722682|"     The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for     pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site     than liver (currently the location of choice for this procedure) thanks to its potential     capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized     phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.   "
119430|NCT01722669|"     The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a     single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase.     Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with     evidence of antiphospholipid antibodies   "
119431|NCT01722656|"     This study will evaluate the use of intravitreal aflibercept (anti-VEGF therapy) in patients     with a type of macular degeneration known as vascularized pigment epithelial detachment.     Previous studies have shown a generally poor outcome in treating this difficult to treat form     of wet macular degeneration. More recently, multiple pilot studies have shown positive     benefits to using anti-VEGF therapy. This study will evaluate the safety and efficacy of     treating vascularize pigment epithelial detachment associated with wet macular degeneration     with intravitreal aflibercept injection.   "
119459|NCT01722292|"     The purpose of this study is to find a recommended dose of LY2940680 that can be safely given     in combination with etoposide and carboplatin followed by LY2940680 alone in participants     with extensive-disease small cell lung cancer. The study will also compare progression-free     survival in participants who are administered etoposide, carboplatin and LY2940680 followed     by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.   "
119432|NCT01722643|"     The overall goal of this project is to develop a novel family friendly intervention that will     help teens with poor metabolic control of their type 1 diabetes increase and sustain daily     self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic     control has long-term health implications. This project will provide important information     regarding new effective ways to improve outcomes among teens with poorly controlled type 1     diabetes.      Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and     maintain glucose control, and (2) improve decision making (improve executive function and     reduce delay discounting), which will predict treatment outcome.   "
119433|NCT01722630|"     Aim of this study was to investigate the cardiac and renal responses to the administration of     different amount of crystalloids, with and without dopamine, during gynaecological     laparoscopic surgery.   "
119434|NCT01722617|"     Rheumatoid arthritis (RA) is a rheumatic inflammatory synovitis characterized by pain and     joint swelling as well as thickening synovial (pannus) lesions that are responsible of     osteocartilaginous and tendon damage. It evolves in spurts or long and variable intensity     interspersed with remissions.      The effectiveness of treatment is based on the proportion of patients who achieve a certain     degree of improvement over the initial level of various parameters such as response criteria     ACR 20, 50 or 70% or EULAR based on the evolution of DAS 28 or DAS 44. These response     criteria are now well validated but do not fully take into account the improvement of the     patient's condition. In contrast, there is no questionnaire to identify the proportion of     patients whose RA worsened between the medical visits. Such a questionnaire is necessary to     detect flares outbreaks in daily practice and in randomized clinical trials, follow-up     studies or longitudinal studies after drugs marketing to detect a reversal of disease     activity.      Both STPR group and OMERACT group have each developed such a new self-administered     questionnaire (FLARE and OM-RA-FLARE) to detect the flare- in RA patients.      The objective of this study is to validate the questionnaires FLARE and OM-RA-FLARE among RA     patients using the methodology advocated by the OMERACT in terms of validity (truth),     discriminating power (discrimination) and feasibility   "
119435|NCT01722604|"     The main purpose of this prospective study is to demonstrate the therapeutic equivalence of     topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic     suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.   "
119436|NCT01722591|"     A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the     Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended     for percutaneous access and closure of the left ventricular apex in conjunction with     transapical Transcatheter Aortic Valve Implantation (TAVI).   "
119554|NCT01721044|"     The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is     superior to placebo in the treatment of participants with moderately to severely active     Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor     (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic     drugs (cDMARDs).   "
119437|NCT01722578|"     Hepatic encephalopathy (HE) is a potentially reversible functional disorder of the brain with     neurological and psychiatric symptoms. HE occurs in up to 70% of patients with cirrhosis at     some time during the course of disease. The chief neurotoxin implicated in the development of     HE is ammonia. An important aim of treatment of HE is the reduction of the ammonia in the     body by lowering the amount of ammonia produced and increasing its detoxification. Enteric     production of ammonia can be decreased by non-absorbable disaccharides such as lactulose and     antibiotics such as rifaximin. L-ornithine- L-aspartate (LOLA), the salt of the natural amino     acids ornithine and aspartate acts through the mechanism of substrate activation to detoxify     ammonia. In clinical trials, LOLA has shown a statistically significant effect with respect     to reduction in HE grade, reduction of blood ammonia concentration and positive effects on     psychomotor function in patients of cirrhosis with minimal HE and overt chronic Grade I HE,     as compared to placebo. However, there is lack of data on the efficacy of LOLA in patients     with overt acute hepatic encephalopathy which is one of the major causes of hospital     admissions and resource utilization in decompensated cirrhotics. Each admission for HE causes     a major financial loss to the family and financial burden on the society. Any drug which     decreases the hospital stay by rapidly improving HE, will clearly lead to decreased hospital     costs to the individual and the society as a whole. Hence, such a trial is a national     priority. The investigators hypothesize that LOLA, if added to the standard treatment of     overt acute HE (i.e lactulose), may lead to a faster recovery and decrease in hospital stay     of these patients. In this prospective, randomized, placebo controlled trial, the     investigators aim to evaluate the efficacy of intravenous L-ornithine, L-aspartate in     reversal of overt acute hepatic encephalopathy in patients with liver cirrhosis.   "
119438|NCT01722565|"     Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the     many prevention and treatment techniques that have been described. Since the introduction of     laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia     remains a surgical problem of considerable importance, requiring significant consumption of     public health and economic resources, and representing a major alteration of the quality of     life of these patients.      Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in     elective surgery for laparoscopic abdominoperineal resection.      Methodology: prospective, multidisciplinary, multi-center randomized controlled study.     Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal     resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic     abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25).     Sample size was calculated based on a proportion of parastomal hernia of 65% in the control     group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are     required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32     patients. The efficacy will be evaluated clinically at six months and abdominal CT will be     performed at 12 months along with another clinical evaluation.   "
119458|NCT01722305|"     This phase I trial studies the side effects and best dose of pomalidomide when given together     with dexamethasone in treating patients with primary central nervous system lymphoma that has     come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma     that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system     to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different     ways to stop the growth of cancer cells, either by killing the cells, stopping them from     dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone     may kill more cancer cells.   "
119512|NCT01721603|"     The purpose of this study is to test the safety and find out what effects, good and/or bad,     dabrafenib (a BRAF inhibitor) alone or dabrafenib when given in combination with gamma knife     radiosurgery has on participants with a certain type of skin cancer (BRAFV600E melanoma) and     brain metastases (tumors that have spread to the brain).   "
119439|NCT01722552|"     The CATS project is designed to increase understanding of interventions that are feasible and     effective in helping injection drug users (IDU) or other patients at high risk of poor     medication adherence who are HIV-positive to maintain a high ART adherence. The study will     involve: assessing the feasibility and acceptability of using real-time feedback, a wireless     technology-updated adaptation of an approach the investigators found to be feasible and     effective in China, to promote ART adherence among Chinese patients, including IDU;     generating preliminary effectiveness data of real-time feedback on adherence, CD4 count, and     HIV viral load; and identifying the factors that explain how real-time feedback influences     intervention success or failure.      The specific aims of the study are:      SA1: Determine the feasibility and acceptability of using real-time feedback, a wireless     technology-updated adaptation of an approach we found to be feasible and effective in China,     to promote ART adherence among Chinese patients. The investigators will conduct a pilot RCT     of the real-time feedback intervention among Chinese patients in order to assess its     feasibility and acceptability in this population.      SA2: Generate preliminary effectiveness data of real-time feedback on adherence, CD4 count,     and HIV viral load. The RCT will allow the researchers to generate rigorous estimates of     effect sizes on these important endpoints.      SA3: Describe the factors that explain how real-time feedback influences intervention success     or failure. The investigators will use a quantitative-qualitative mixed-methods research     approach to explore how the intervention influences the experience of adherence support in     this patient population.   "
119440|NCT01722539|"     Considering the facts that: (i) IPT of malaria provides substantial protection against     anaemia and malaria in school children (ii); SP resistance has no significant impact on the     prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators     hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration,     reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and     school performance in school-aged children of Congo.   "
119441|NCT01722526|"     To evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of rhASM     in adult patients with Acid Sphingomyelinase Deficiency (ASMD) following repeated-dose     administration.   "
119442|NCT01722513|"     The aim of this prospective, randomized, controlled study is to investigate the effect of     pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population     of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary     angiography, and evaluate the influence of such potential benefit on short-term outcome.   "
119443|NCT01722500|"     The primary aim of the International Study of Childhood Obesity, Lifestyle and the     Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and     obesity in a large multi-national study of 10 year-old children, and to investigate the     influence of behavioral settings and physical, social and policy environments on the observed     relationships within each country.   "
119444|NCT01722487|"     A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase     Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive     Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.   "
119474|NCT01722097|"     The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain.     Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure     (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).      Primary hypothesis:      Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative     pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).   "
119598|NCT01720472|"     The purpose of this study is to use the MURDOCK Horizon 1.5 infrastructure (Duke Instutional     Review Board Pro00011196) to specifically target and enroll 1,000 participants across age     groups and other demographic categories in order to develop a diverse cohort with specific     physical and cognitive performance data paired with biological samples.   "
119445|NCT01722474|"     The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational     device under development for the non-invasive assessment of arterial stiffness. The ASI     Device is considerably smaller and more cost effective than its commercially available     counterparts. As the device is readily portable, it is intended to be targeted for use in the     community (or at home), as opposed to within the hospital or clinic setting only. However, as     the device is still under development, it is not known whether it is capable of determining     arterial stiffness with the same sensitivity and consistency as those already in commercial     use. An added variable is the fact the sensor for the ASI Device is located on the fingertip.      Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic     purposes. The ASI Device has not been tested against other instruments capable of providing     similar measurements. Therefore, a clinical trial to compare the ASI Device against similar     devices is necessary. The study will compare measurements of arterial stiffness and other     central haemodynamic parameters obtained with the ASI Device against similar measurements     from devices that have already been approved for this purpose by Health Canada/United States     Food and Drug Administration (FDA).   "
119446|NCT01722461|"     This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will     be randomly assigned to receive either active treatments for axillary hyperhidrosis with the     Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the     energy settings on the device set to deliver no ultrasound energy. Subjects will be     randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one     subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.      Subjects and study personnel conducting efficacy measures will be blinded to the assigned     treatment groups. The study hypothesis is that subjects in the active treatment group will     have a greater reduction in underarm sweating compared to those in the sham group as measured     by a quality of life questionnaire.      All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their     first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their     second study treatment. Subjects in the active treatment group will also undergo follow-up     assessments at 9 months and 12 months from the date of their second study treatment.   "
120247|NCT01711970|"     This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the     safety and tolerability of the combination of intravenous administration of VB-111 and     paclitaxel in patients with platinum resistant ovarian cancer.   "
119448|NCT01722435|"     Only limited information on the process of completing long-term opiate substitution treatment     (OST) with substances like methadone exist. Furthermore, systematic knowledge from scientific     studies is scarce, there are only few studies with respect to treatment completion or regular     termination (mainly catamnestic analyses). Studies by Nordt et al. (2004) or Nordt & Stohler     (2006) show an estimated rate of 10% of patients per year who terminate OST by means of     tapering the substitution agent or changing into withdrawal treatment in specialized clinics.     It is state of the art that an indication for termination of OST has to be based on a common     agreement between the patient and the doctor. Furthermore, the patient should live in a     stable social situation and the state of health had markedly improved. Finally, the patient     has to be free of (illegal) drug use for at least 6 months and the individual aims of     treatment should have been reached (Vader et al. 2003).      The main objective of the prospective and explorative study is the systematic description of     the process of termination of OST. With a comparison between patients who complete OST     regularly and patients who terminate treatment prematurely (or are still in treatment)     predictors of positive termination of OST can be identified.      Patients treated with methadone or levomethadone of 5 general practitioners' practices and 2     specialized clinics who might be able to terminate OST during the next 12 months from the     doctors' perspective can take part in the study. In addition to baseline examination further     assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires     include state of health, well-being, social situation as well as drug and alcohol use.     Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on     infections and other disorders, clinical characteristics, dosage process and drug use     (measured by urine samples).      Patients who will be successful in completing OST during the observational period will be     compared with the remaining cases.      Finally, a 6-month follow-up is planned in order to investigate the stability and maintenance     of the situation at month 12.   "
119449|NCT01722422|"     Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with     septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion     and oxygenation and may reduce the organ failure occurences. To date, only scarce data are     available. Side effects are not well described. Therefore we designed a randomized clinical     trial in order to assess the early administration of hypertonic saline and oxygen in the very     early beginning of septic shock.   "
119450|NCT01722409|"     The investigators designed a double-blind, randomized placebo-controlled study to determine     the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled     to undergo endovascular coil embolization.   "
119451|NCT01722396|"     Previous studies of vitamin D supplementation have suggested there may be differences in     response between individuals. This study is an open label study of vitamin D supplementation     in patients with active or latent tuberculosis in which active disease patients take     100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for     relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex     vivo markers of vitamin D response. Latent patients will only be studied for vitamin D     response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells     will be related to polymorphisms in the DBP gene, and that this may relate to clinical     response in terms of post supplementation vitamin D level.   "
119452|NCT01722383|"     Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with     significant morbidity and mortality. People at highest risk from progressive CKD are defined     by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of     significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of     this group will enable improved risk stratification and direct the development of better     targeted management for people with CKD. To address these requirements we have established     the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients     at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical     phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent     follow-up.   "
119599|NCT01720459|"     The purpose of this study is to determine whether micronized trans-resveratrol improves     clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids,     markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).   "
119453|NCT01722370|"     Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels,     because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15     hours per day, and has established indications and benefits in COPD. However, the indications     for and benefits from ambulatory oxygen supplementation (oxygen just when walking or     exercising) are less well understood, in part due to heterogeneity of previous study designs,     and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in     COPD, which allows us to ascertain mechanisms of disease by measuring their degree of     systemic inflammation pre and post oxygen supplementation, and measuring changes in gene     expression in muscles by means of microarray profiling. Secondly, our study will utilise     follow up of clinical parameters including home activity monitoring to ascertain medium/long     term benefits of oxygen supplementation in a real life setting. Our hypothesis is that     exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.   "
119454|NCT01722357|"     The purpose of the study is to address 3 main sets of questions in the bariatric surgery     population. 1) Does bariatric surgery, without any other intervention, lead to increased     physical activity and improved physical fitness? 2) Does wearing a pedometer lead to     increased physical activity in obese individuals prior to and/or after bariatric surgery?     Does the increased activity result in improvements in physical fitness? 3) Does physical     activity counseling increase physical activity prior to and or/after bariatric surgery? Does     the increased activity result in improvements in physical fitness? The overall goal of the     study is to determine the impact of bariatric surgery on physical activity and assess the     utility of additional interventions to help postoperative patients adopt a more active     lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus     exercise counseling before and for the first 6 months after bariatric surgery. In an     extension of the primary study, from 1 to 5 years after surgery, all patients receive     exercise counseling. Physiological measures will be assessed to determine whether bariatric     surgery and/or improved physical activity levels result in improved physical fitness.   "
119455|NCT01722344|"     The purpose of this study is to investigate the efficacy of IPS in Denmark and compare     effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and     work-related social skills training vs. 3. standard intervention, among individuals with     severe mental illness.   "
119456|NCT01722331|"     This study is being conducted to evaluate the efficacy and safety/tolerability of     subcutaneous MK-3222, followed by an optional long-term safety extension study, in     participants with moderate-to-severe chronic plaque psoriasis.   "
119457|NCT01722318|"     This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in     patients with IBS-C.   "
119460|NCT01722279|"     The primary purpose of this study is to examine the breadth, nature, and factors affecting     the long term changes in physical and psychological health and quality of life (QOL)     following bariatric surgery. Data will be gathered via electronic survey (SurveyMonkey),     postal mail, or phone, or using a standardized questionnaire expected to last 25-35 minutes.     Archival data available from patient medical records will also be gathered.   "
119461|NCT01722266|"     Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting,     postprandial and the overall mean glucose concentrations.      Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of     weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and     following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. In     addition, the time spent at glucose concentrations >150 and 200mg/dl and <70 and <40 mg/dl     will also be compared.      Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and     after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose     concentrations will be measured as areas under the curve for the data obtained from the meal     challenge.      Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment     with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in     patients with type 1 diabetes decreases postprandial glucagon concentrations and increases     postprandial C-peptide concentrations.      Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following     a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide     daily.      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric     emptying.      Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and     after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.   "
119462|NCT01722253|"     The purpose of this study is to determine whether electroacupuncture is a effective tool to     the postoperative analgesia   "
119482|NCT01721993|"     THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the     safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in     healthy postmenopausal women. The study is expected to identify a safe dose that can be     further tested in subsequent multiple dose studies comparing the safety, PK and     pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).   "
119902|NCT01716494|"     The overall goal of this proposal is to better understand the basis of airway remodeling in     severe asthma and how remodeling changes over time. The investigators propose to study a     well-characterized cohort of adult and pediatric subjects with severe asthma using a     multidisciplinary state-of-the-art approach.   "
119463|NCT01722240|"     The control of glucose homeostasis in subjects with type 1 diabetes is fragile since     exogenous insulin cannot compensate for changing requirements and is not precise either in     terms of the dose or the bio-availability of the insulin injected. Furthermore, in the near     total absence of insulin secretion, the physiological post prandial inhibition of glucagon     secretion by the α-cell is also probably deficient in all type 1 diabetics. Thus, there is a     need for therapies beyond insulin that can further improve glycemic control and reduce     fluctuations in glucose in these subjects. The investigators have recently shown that     Liraglutide, a glucagon like peptide (GLP)-1 analogue with duration of action of 24 hours,     when added to insulin in subjects with well controlled type 1 diabetes reduces mean and     standard deviation of blood glucose, HbA1c and insulin requirements. Since C-peptide     concentrations did not alter following Liraglutide, it is likely that the suppression of     glucagon may have contributed to this effect. The glucose lowering effects of GLP-1 agonists     are well established in subjects with type 2 diabetes, however, these have not been studied     prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed     this study to investigate the central hypothesis that in patients with type 1 diabetes,     Liraglutide has a glucose lowering effect. A major secondary objective of this study is to     elucidate the mechanisms responsible for its glucose lowering effects and those involved in     reducing the insulin dose. The specific aims of this proposal are:      Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c,     fasting, postprandial and the overall mean glucose concentrations while decreasing the dose     of insulin required.      Aim 1.1: To compare the HbA1c, mean fasting, glucose, mean weekly glucose, standard deviation     of weekly blood glucose concentrations as recorded by continuous glucose monitoring and the     dose of insulin required prior to and following 52 weeks of treatment with 1.2 mg of     liraglutide daily.      Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and     after 52 weeks of treatment with 1.2 mg of liraglutide daily.      Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and     postprandial glucagon concentrations and increases basal and postprandial C-peptide     concentrations.      Aim 2.1: To compare the basal and postprandial glucagon and C-peptide concentrations     following a test meal before and after 52 weeks of treatment with 1.2 mg of liraglutide     daily.      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric     emptying.      Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and     after treatment with 1.2 mg of daily subcutaneous liraglutide.   "
119464|NCT01722227|"     This is the first prospective randomized double-blind placebo-controlled study to investigate     the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and     variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the     preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of     the drug are consistent with a sustained duration of action. The current gold standard for     management of type 1 diabetes is based on insulin replacement with novel analogs with     specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump     therapy). No other adjuvant therapy has demonstrated sustained benefit in this population.     This study will also investigate the effect of liraglutide on suppression of glucagon     secretion during meal challenges. This is of particular importance since, in the absence of     insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by     the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall     pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will     allow us to determine the rapidity, consistency, and sustainability of any response to     liraglutide.   "
119465|NCT01722214|"     This study is a double-blinded randomized multicenter placebo controlled trial to determine     the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients     with moderate to severe psoriasis.   "
119466|NCT01722201|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fasting condition in     normal, healthy, adult human subjects.   "
119467|NCT01722188|"     This is a prospective, multi-center, actively monitored, long term data collection registry.     Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a     compatible market released cardia rhythm management (CRM) implantable pulse generator is     eligible for enrollment into the registry.   "
119468|NCT01722175|"     This randomized phase II trial compares how well associating liver partition with portal vein     ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating     patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing     liver cancer. ALPPS may be more effective than PVO in patients whose disease would     traditionally be considered inoperable.   "
119469|NCT01722162|"     This randomized phase II trial studies how giving a drug called levocetirizine to patients     with colorectal cancer affects their tumor response to capecitabine and bevacizumab.     Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA     synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that     blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels     that feed them. Patients with colorectal cancer can develop a resistance to the effects of     bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving bevacizumab,     capecitabine, and levocetirizine dihydrochloride together may be an effective treatment for     refractory colorectal cancer.   "
119470|NCT01722149|"     MPM patients are not eligible for surgical procedures like decortication or     pleuro-pneumectomy and have a median survival of 12 months with palliative chemotherapy.     Therefore, new therapeutic approaches are of crucial need in this clinical situation. This is     a phase I trial for patients with malignant pleural mesothelioma with pleural effusion     testing the safety of a fixed single dose of 1x10e6 adoptively transferred FAP-specific     re-directed T cells given directly in the pleural effusion. Lymphocytes will be taken 21 days     before transfer from peripheral blood. CD8 positive T cells will be isolated and     re-programmed by retroviral transfer of a chimeric antigen receptor (CAR) recognizing FAP     which serves as target structure in MPM.        -  Trial with immunomodulatory product / biological   "
119471|NCT01722136|"     The overall goal is to determine whether any energy expenditure compensation in response to     16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose     intervention in older women, and to begin to investigate underlying physiological mechanisms     that influence energy expenditure changes in older women.   "
119472|NCT01722123|"     Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The     result is decision fatigue, in which subsequent decisions are altered toward the status quo.     Patients are at risk for decision fatigue yet it has not been studied. The Investigator     proposes a randomized study in the outpatient setting in patients at high risk for needing to     make complex decisions, in an effort to determine the impact of decision fatigue on     participant self-control and subsequent choices.   "
119473|NCT01722110|"     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fed condition in normal,     healthy, adult, male and female human subjects.   "
119493|NCT01721850|"     The study is conducted to examine the safety and efficacy of a new infant formula and its     effects on the gastrointestinal tolerance in infants suffering from colic.      Primary hypothesis to be tested is: an infant formula with optimized composition improves     colicky symptoms compared to a standard formula.   "
119475|NCT01722084|"     Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe     abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on     unidirectional interventions aiming at a single determinant of adolescents´ sexual and     reproductive health. However, evidence exists that a complex health problem should be     addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to     develop a comprehensive approach to promote adolescents' sexual health.      The CERCA study will conduct an implementation based on the hypothesis that a comprehensive     strategy of community-embedded interventions helps to improve the sexual health of     adolescents. We will test this hypothesis and describe the development, implementation and     testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca     (Ecuador) and Managua (Nicaragua).      The research methodology has been designed based on the methodological frameworks of action     research, community based participatory research and intervention mapping.      The interventions are complex addressing different target groups (adolescents, parents,     authorities and health providers) and focussing on various behaviours that are related to     communication about sexuality, information seeking, access to health care and safe sexual     intercourse.      For the evaluation of effectiveness a randomised and non-randomised controlled study was     developed for respectively Managua and the two other cities. Furthermore a process evaluation     is conducted.      This research will result in a framework that will contribute to the planning of     interventions that are effective and responsive to adolescents' sexual health needs.   "
119476|NCT01722071|"     The proposed study will investigate the effects of intranasal oxytocin administration on     neural activity associated with social and non-social motivation.   "
119477|NCT01722058|"     You are invited to participate in a research study to develop new ways to look for abnormal     areas/tissues of the colon. The current endoscopes used to look at the colon are very good,     but if the area doesn't look different to the naked eye, then the endoscope can't improve on     that. We are looking at using special fluorescent stains in addition to special endoscopes     designed to see abnormal areas that are not obvious to the naked eye. Currently specialized     microscopes and fluorescent stains are used in clinical laboratories but it takes several     days of processing to get results. It may be very helpful to look for areas to sample for     abnormal tissue during the endoscopy procedure.      You are being asked to let us spray a fluorescent peptides into your right colon. Peptides     are small chains of amino acids (the building blocks that make up proteins) linked together.     Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the     one used by your eye doctor).      We have prepared this special fluorescent peptide to target and bind to any abnormal areas     if present, and glow when a special light is used. In this study, we will apply the special     fluorescent peptide by a spray catheter to your right colon to asses for safety. The     colonoscope used in this study is the usual colonoscope used and is not able to see the     fluorescence.      This is a phase 1 study. This means that this is the first time we have used this kind of     fluorescent peptide in people. The Food and Drug Administration (FDA) has not approved this     agent, but is allowing us to test it in this study. The goal of this study is to see if there     are any side effects from using the peptide. We have used a similar peptide that we've     developed for the esophagus in over 40 patients without any side effects.      This is the first test of this agent, so it won't be used to change how colonoscopy is done.   "
119478|NCT01722045|"     This is a phase 4, open-label, single arm, multicenter, clinical study in patients with     neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept     Injection (IAI) administered over 2 years , and to provide clinical information from the     first year in the trial evaluating the adverse effects, if any, on the corneal endothelium     following administration of IAI.   "
119513|NCT01721590|"     Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent     reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this     prospective randomized study,all patients in control group will receive blank placebo ,all     patients in test group will receive tongxinluo.All patients will be followed up for one year.   "
119479|NCT01722032|"     Background: Many unhealthy dietary and physical activity habits that foster the development     of obesity are established by the age of five. Presently, approximately 70 percent of     children in the United States are currently enrolled in early childcare facilities, making     this an ideal setting to implement and evaluate childhood obesity prevention efforts. We     describe here the methods for conducting an obesity prevention intervention randomized trial     in the child care setting.      Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income,     ethnically diverse child care centers located throughout Miami-Dade County, FL is currently     being conducted over two years (2010-present) to test the efficacy of an intervention that     poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy     Children (HC2) program includes a curriculum focusing specifically on healthy food choices,     increased exercise, and role modeling. The program targets food policy changes throughout the     school, and via the child, caregiver, and teacher. Major outcome measures include child body     mass index percentile and z score, fruit and vegetable and other nutritious food intake, and     amount of physical activity.      Discussion: Although few attempts have been made to prevent obesity during the first years of     life, this period may represent the best opportunity for obesity prevention. Findings from     this investigation should inform both the fields of childhood obesity prevention and early     childhood research about the effects of an obesity prevention program housed in the childcare     setting. (H1) A child care center-based obesity prevention intervention program that includes     a teacher and parent nutritional gatekeeper and role modeling program will be more effective     in maintaining BMI in 3-5 year olds compared to a control group.      (H2) Role modeling (teacher and parent) will be identified as a significant mediator in     preventing obesity among intervention children versus controls.      (H3) A child care center-based multi-level obesity prevention intervention program will     improve child nutrition (increased consumption of fruits and vegetables, decreased     consumption of sweetened beverages) and increase physical activity level compared to a     control group.   "
119480|NCT01722019|"     Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open     crossectomy and stripping. The two most performed techniques for endovenous ablation are the     endovenous laser ablation and the radiofrequency ablation. According to the trial of     Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in     more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in     observational studies. The aim of this study is to compare radiofrequency ablation with the     VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new     fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point     necroses of the vessel wall and on consequence results in lesser side effects from wall     perforations such as pain, haematoma,…   "
119481|NCT01722006|"     Classical conditioning is widely used to study motivational properties of addictive drugs in     animals, but has rarely been used in humans. Here, we are establishing a procedure suitable     for studying the neurobiology and individual determinants of classical conditioning in     humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine     or placebo in the presence of distinctive environmental cues under paired or unpaired     conditions. During each session, subjects perform tasks known to activate the ventral     striatum in fMRI studies. The tasks are performed in the presence of a distinctive context,     consisting of a screen background image of a beach or of mountains, accompanied by     corresponding sounds. Separate groups of subjects carry out the tasks under high or low     reward conditions. Within each of the two reward conditions, one group (paired), receives     methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts,     while the other (unpaired) receives drug or placebo unrelated to context. A fifth group     (paired) perform the tasks with contextual cues but in the absence of monetary incentives.     Before and after conditioning, participants carry out a series of forced choice tasks, and     change of preference over time was analyzed.   "
119494|NCT01721837|"     Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke     prevention in patients with atrial fibrillation and mild to moderate renal impairment   "
119483|NCT01721980|"     The purpose of this study is to evaluate the safety and tolerability after multiple ascending     oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.      Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and     urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related     parameters in the blood and stool samples (pharmacodynamics) will be characterized compared     to placebo.      Also, the effect of the compound on glucose tolerance will be explored as well as the     potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.   "
119484|NCT01721967|"     The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic     Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical     therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for     the treatment of angina in a novel patient population (adult patient population with     hypertrophic cardiomyopathy).   "
119485|NCT01721954|"     This study is a randomized, multi-center study that will compare the efficacy and safety of     selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard     chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with     non-resectable liver metastases from primary colorectal carcinoma.      Treatment with the biologic agent bevacizumab, if part of the standard of care at     participating institutions, is allowed within this study at the discretion of the     Investigator.   "
119486|NCT01721941|"     The primary objective of this phase I dose escalation study is to determine the maximum     tolerated dose of TH-302 when administered with doxorubicin via trans-arterial     chemo-embolization (TACE) in patients with hepatocellular carcinoma (HCC) who are not     transplant candidates and have unresectable disease. HCC is the second leading cause of     worldwide cancer death and is generally incurable without liver transplant. TACE can convert     about 40% of these patients to transplant candidates. Additionally, in non-transplant HCC     patients, TACE confers statistical improvements in overall survival. Selective HCC arterial     catheterization during TACE allows for the delivery of concentrated drugs to the liver tumor     but the optimal TACE chemotherapy regimen has not yet been determined. TH-302 is a hypoxia     inducible agent that can be activated in the hypoxic environment induced by TACE.   "
119487|NCT01721928|"     The main purpose of the NORIDES study is to investigate the effect of pharmacological     thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and     how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis.     The main objective is to compare the prophylactic effect of dalteparin in intensive care unit     (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis) with a control group of     ICU patients with normal kidney function. Our main hypothesis is that CiCa-dialysis reduces     dalteparin effect, and that patients undergoing CiCa-dialysis do not achieve adequate     prophylaxis against venous thromboembolism (VTE). The primary endpoint is development of DVT     during ICU stay, the secondary endpoint inadequate heparin effect measured in blood samples.   "
119488|NCT01721915|"     Background: Polycystic ovary syndrome (PCOS) is as common as 5-10% of all women in Austria.     PCOS women frequently present with metabolic disturbances, hyperandrogenism and infertility.     New therapy concepts are warranted. In our recent pilot study, vitamin D (vitD)     supplementation significantly improved glucose metabolism and fertility. However, the     efficacy of vitD administration shows individual variability indicating endogenous influences     on pharmacological effects.      A recent genome-wide association study reported three loci (DHCR7, CYP2R1, and GC) associated     with vitD insufficiency. Moreover, vitD receptor (VDR) gene variants have already been known     to be associated with insulin resistance.      Aim: To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS     and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD     related genetic determinants adjusted for environmental factors.      Primary outcome: Change from baseline in AUCgluc after vitD treatment. Secondary outcome: To     generate the hypothesis that changes in metabolic and endocrine parameters following vitD     treatment are associated with vitD related gene variants.      Methods: 150 PCOS women with 25-hydroxyvitamin D (cholecalciferol, [25(OH)D]) levels <30     ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled     trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD     related genetic variants. In addition, 150 non-PCOS women with 25(OH)D <30 ng/ml will be     treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24     weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic     variants. The response to vitD supplementation in both groups will be analysed according to     genotype profiles.      Significance: VitD might be a new therapeutic option without major side effects for PCOS     patients. Exploring specific loci for pharmacogenetic vitD actions would open a new window     for therapy modulation in PCOS and other metabolic diseases.   "
119489|NCT01721902|"     The primary objective of this study is to demonstrate the feasibility and safety of     intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at     the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic     cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem     cells will be assessed.      The investigators hypothesize that collection of a sufficient number of CD133+ cells through     bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial     injection of high purity cells following completion of CABG, will be feasible without     significant adverse clinical consequences.   "
119490|NCT01721889|"     The primary objective of this pilot study is to determine the precision of post-operative     radiostereometric measurements for the assessment of lumbar spinal fusion. This study will     also determine the potential for RSA as a more precise and accurate means for assessment of     lumbar spinal fusion and diagnosis of pseudarthrosis.   "
119491|NCT01721876|"     To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib +     subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated     acute myeloid leukaemia, ineligible for intensive remission induction therapy   "
119492|NCT01721863|"     Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms     of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with     increased vagal tone. Patients with AF have poor exercise capacity that may contribute to     decreased atrial effective refractory period, and decreased cardiac output and heart rate     reserve, and may result in poor quality of life. Poor endothelial function had been noted in     patients with AF, associated with increased risks of cerebrovascular and cardiovascular     disease. Exercise training has been noted to improve exercise capacity and quality of life in     patients with AF only in some studies. Endothelial function can be improved by exercise     training in patients with cardiovascular disease, but no report in patients with AF. Evidence     of exercise training is still needed in patients with AF. The purpose of this study is to     investigate the effect of exercise training on        1. endothelial function        2. heart rate variability        3. exercise capacity        4. quality of life.   "
119495|NCT01721824|"     The aim of the present study, is to evaluate the effect of a supported employment     intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or     education, when offered to people with onset mood or anxiety disorders who are not likely to     be able to return to work within three month.      The hypothesis is that the IPS-MA method is associated with a shorter recovery period and     more people returning to work or education, compared to treatment as usual.   "
119496|NCT01721811|"     The aim of the study is to investigate how the retina adapts to different metabolic     challenges, e.g. chronic systemic hypoxia, hyperglycemia, special training conditions or     diets as well as transient changes in the content of oxygen and glucose in the blood.   "
119497|NCT01721798|"     This study will inform international medical guidelines as to whether the Levonorgestrel     intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive     method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for     HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and     acceptable, the introduction of this method to HIV positive women in developing countries     could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and     confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.   "
119498|NCT01721785|"     The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI     and gadofosveset-enhanced MRI for the management of rectal cancer patients.   "
119499|NCT01721772|"     The purpose of this study is to compare the clinical benefit, as measured by overall     survival, of nivolumab with that of. dacarbazine in patients with previously untreated,     unresectable, or metastatic melanoma   "
119500|NCT01721759|"     The purpose of the study is to assess the objective response rate (change in tumor size from     baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer     treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens   "
119501|NCT01721746|"     The purpose of the study is to estimate the response rate and compare overall survival of     patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or     Carboplatin and Paclitaxel   "
119502|NCT01721733|"     The purpose of this study is to evaluate the effects of EPI-743 in children with Leigh     syndrome on disease severity, neuromuscular function, respiratory function, disease morbidity     and mortality and disease associated biomarkers.   "
119514|NCT01721577|"     This is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the     safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent     formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas     (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic     oligoastrocytoma, and anaplastic ependymoma). Patients will be treated for up to 5 cycles. A     treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28 days     during cycle 5). The following cycle will not be started until the treatment continuation     criteria are fulfilled. Concomitant supportive therapies will be allowed.   "
119503|NCT01721720|"     Background:      - Attention deficit hyperactivity disorder (ADHD) is one of the most common and inheritable     of all neuropsychiatric disorders. It causes problems with attention and impulse control.     However, the genetic component of ADHD has not been fully studied, including how genes     interact with the environment. Researchers want to study children and adults who have ADHD.     They will look at how genetic, brain structure, and environmental factors affect ADHD in     children and adults.      Objectives:      - To study genetic, brain structure, and environmental factors in ADHD in children and     adults.      Eligibility:      - Individuals at least 3 years of age who have ADHD.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will be interviewed about their ADHD. They will also complete behavior and          psychological tests. Parents or guardians will complete the tests along with          participants under 18 years of age.        -  Participants will provide saliva or blood samples.        -  Participants will also have imaging studies of the brain.        -  Participants under 25 years of age will return once a year to repeat the tests. Those          over 25 years of age will have only the one set of tests. Those who are starting          stimulant drugs and who are receiving behavioral treatment for the first time will also          have another set of tests 12 weeks after the start of treatment.   "
119504|NCT01721707|"     This study is a double-masked, randomized, parallel group study in patients with open angle     glaucoma or ocular hypertension.      The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50     mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in     reducing IOP   "
119505|NCT01721694|"     To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5%     Loteprednol eye drops for the treatment of ocular inflammation and infection associated     bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual     administration of azithromycin 1.5% and 0.5% Loteprednol (separately).   "
119506|NCT01721681|"     The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of     bleeding when given as routine prophylaxis over 12 months.      The secondary objectives of the study are:        1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg.        2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26          weeks).   "
119507|NCT01721668|"     Improving arm and hand function after stroke has been difficult to achieve within the     rehabilitation service provided in the acute stage often due to the limited resource in     health care. While spontaneous recovery plateaus after 6 months, the prolonged disability     affects quality of life and social participation in stroke survivors. This study is aimed at     improving chronic motor impairment arm and hand impairment by providing the intervention with     intensive training schedule. This study will compare two types of rehabilitation intervention     using a randomized controlled trial. Measurements also will be taken on various brain     functions non-invasively to help discover how each of the intervention strategies works     differently to repair the brain.   "
119522|NCT01721473|"     Cigarette smoking is more prevalent among Veterans (27%) than the general U.S. population     (21%). Smoking is common among people who use marijuana or caffeine heavily, and the use of     menthol cigarettes is becoming increasingly common, affecting approximately 9% of the Veteran     population. Recent research by the group and others indicates that heavy marijuana or     caffeine use, or the use of predominantly menthol cigarettes, can alter brain nicotinic     acetylcholine receptor (nAChR) densities. For the proposed study, brain imaging with PET     scanning will be used to determine nicotine receptor densities in Veteran cigarette smokers     with and without heavy marijuana or caffeine use, and in menthol and non-menthol Veteran     smokers. Results of the proposed research may have implications for improving treatments for     Veterans who smoke cigarettes and who have specific drug use co-morbidities or who use     menthol cigarettes.   "
119508|NCT01721655|"     Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major     complication of premature birth and is associated with a significant increased risk of     complications including death. Diuretics have been used for decades in babies with BPD and     are considered a standard of care. Patients receive electrolyte supplementation to replace     the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics     at removing extra fluid, but it is different from chlorothiazide and furosemide because     instead of removing potassium, it actually can increase potassium levels in our body.     Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore,     reduce the electrolyte supplementation needed. However, studies have suggested that preterm     babies aren´t developed enough to appropriately respond to spironolactone. Also, one study     has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on     whether or not patients receive electrolyte supplementation. This study will examine whether     there is a difference in the amount of electrolyte supplementation between patients receiving     chlorothiazide only or chlorothiazide plus spironolactone. the investigators hypothesize     there will be no difference in the amount of electrolyte supplementation between the two     groups.   "
119509|NCT01721642|"     A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and     Closure Device for accessing and closing the left ventricular apex during and after     Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made     post-procedure, at 30 days and 90 days as well as longer term follow-up.   "
119510|NCT01721629|"     The aim of this study is to investigate two different strategies for the withdrawal of CPAP     in preterm infants born before 32 weeks of gestation.   "
119511|NCT01721616|"     Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as     the most frequent post-cesarean delivery complication. This increased morbidity translates     into extended post-partum antibiotic use and prolongation of hospital stay with the     subsequent increase in health care expenses. The current regimen recommended by the American     College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation     cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been     associated with an increased risk of endometritis in post-cesarean section patients.     Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely     covers Ureaplasma and would be an excellent second antibiotic for cesarean section     chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard     chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section     endometritis.   "
119516|NCT01721551|"     The purpose of the current study is to investigate whether changes in patients' sleep quality     and quantity will be followed by improvements in parameters related to physical and mental     fatigue in patients receiving hemodialysis therapy.      More specific, the current project will investigate the effect of a 9 months intradialytic     exercise training in aspects related to fatigue, quality of life and depression.   "
119517|NCT01721538|"     SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary     prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with     two arms. The therapy arm is participating in a comprehensive weight reducing program,     whereas the control group takes part in a lecture on healthy nutrition. The primary study     objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary     prevention of stroke. Secondary objectives are functional outcome, cognitive status, post     stroke depression, and health-related quality of life.   "
119518|NCT01721525|"     This study seeks to develop a new induction chemotherapy regimen which is a combination of     two pill drugs taken by mouth and two drugs given by vein. This is a phase I study, which     means that the primary goal is to establish the recommended dose of an investigational drug     when added to chemotherapy. The researchers wish to evaluate the effects, good and bad, of     the investigational drug.   "
119519|NCT01721512|"     Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta,     Indonesia   "
119520|NCT01721499|"     This is a study of treatment approaches aimed to improve self-control and decrease stress and     unhealthy/maladaptive behaviors such as drinking, overeating, and smoking.      High levels of stress may make it harder to maintain self-control, especially when trying to     control our unhealthy behaviors. Training on improving self control and decreasing stress may     help decrease unhealthy behaviors. The goal of this new training program will be to decrease     a subject's unhealthy behavior by helping them better manage their stress and improve their     self control over unhealthy habits.   "
119521|NCT01721486|"     The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain     control in children undergoing tonsillectomy with or without adenoidectomy.   "
119523|NCT01721460|"     The purpose of this research study is to find out whether dexmedetomidine changes brain cell     activity in the subthalamic nucleus (STN).      In order to find whether dexmedetomidine is optimal for sedation during Deep brain     stimulation surgery, we will measure the electrical activity in the STN during Deep brain     stimulation surgery, and measure how this activity is changed during administration of     Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and     pattern in the STN.   "
119524|NCT01721447|"     The investigators intend to determine if using Optison echocardiography contrast increases     sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal     echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo     contrast.   "
119525|NCT01721434|"     Levosimendan is a relatively new drug that improves cardiac contractility in patients with     heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial     contractile proteins. Recent data from our lab showed that levosimendan improves     contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in     vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of     disorders associated with impaired respiratory muscle function, such as mechanically     ventilated patients.We hypothesize that levosimendan could improve respiratory muscle     function in mechanically ventilated patients commencing a CPAP trial.   "
119526|NCT01721421|"     Design: Prospective randomised cross-over study. Fifty-two eligible patients will be     randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and     following a washout period of 4 weeks, switch to the alternative treatment time for an     additional 24 weeks.      Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours     thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from     baseline in outcome measures over a total 12-month period.      Primary outcome measure      1]Serum albumin      Secondary outcome measures Nutritional status        1. Malnutrition-inflammation score        2. Dietary intake        3. Hand-Grip strength        4. Energy expenditure      Quality of life        1. Patient reported quality of life and        2. time to recovery from dialysis      Serum biomarkers        1. BNP        2. Troponin        3. MCP-1      Others 24- hour Ambulatory blood pressure 24-hour accelerometer      Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on     haemodialysis treatment Duration: Fifty-six weeks   "
119527|NCT01721408|"     This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin     in hospitalized patients with a complicated intra-abdominal infection.   "
119528|NCT01721395|"     Cough is a frequent symptom in children and infants and is one of the most common reasons     parents visit a healthcare provider for their child. The US Food and Drug Administration has     issued a warning that over-the-counter cough and cold medicines including antihistamines,     decongestants, anti-tussives, and expectorants should not be administered to children younger     than 2 years of age due not only to lack of proven efficacy, but also because of important     safety concerns. Honey, another method of soothing cough cannot be used in children <1 year     due to concerns for infantile botulism. A preparation from agave syrup has been created to     address the need for an infant cough syrup. Although no studies have formally evaluated the     use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the     demulcent effect and sweet taste of agave nectar may provide some relief from cough in     children.   "
119529|NCT01721382|"     This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes     but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose     regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),     will be performed at baseline and again ~4 weeks after treatment with study drug. We will     also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before     each time the MMTT/OGTT are performed. Several hormones that may affect the way the body     regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will     assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine     has on the hormones measured during the OGTT and MMTT.   "
119531|NCT01721356|"     Emotional Intelligence (EI) is defined as the ability to accurately perceive and identify     emotions in oneself and others, understand and use emotions to enhance cognitive processes,     and effectively manage one's own emotions as well as those of others. Two major approaches to     the construct of emotional intelligence have emerged. These two approaches can be broadly     defined as the Trait and Ability Approaches. The Trait Approach, which is typically assessed     via self-report measures such as that Bar-On Emotional Quotient Inventory, appears to be     strongly related to existing models of personality and coping. The other major approach to EI     follows an Ability Model, assuming that EI is similar to but distinct from other types of     cognitive intelligence, and involves measurement of a variety of skills and abilities related     to emotional processing. An understanding of the neurobiological substrate of emotional     intelligence is beginning to emerge. One influential theory that is particularly relevant to     the neurobiology of emotional intelligence is the somatic marker hypothesis, yet there     still remains a limited understanding of the neurobiological basis of EI. The proposed     investigation will attempt to provide the most comprehensive study to date examining the     behavioral, psychological, functional, and brain structural correlates of EI. The proposed     study will use neuroimaging techniques to examine the relationship between current measures     of EI, behavioral expression of emotionally competent capacities, brain functional responses,     and structural cerebral organization.      The specific questions to be addressed and their associated hypotheses are:        1. The two major approaches to EI (i.e., Trait vs. Ability) will show only modest, though          significant positive correlations with one another.        2. EI Trait measures will be highly correlated with measures of personality but weakly          correlated with specific skills such as facial affect identification, emotional          decision-making, and affectively based judgments, whereas EI Ability measures will          correlate more highly with specific emotional skill measures.        3. During functional MRI affective challenge tasks, EI scores will be negatively correlated          with activity within the Somatic Marker Circuitry suggested by Damasio and colleagues          (i.e., ventromedial prefrontal cortex, amygdala, insular cortex), as suggested by the          neural efficiency hypothesis.   "
119532|NCT01721343|"     This randomized clinical trial studies collaborative targeted case management in improving     functional status in patients with stage III-IV cancer. Collaborative targeted case     management may improve functional status and preserve performance in patients with advanced     cancer   "
119553|NCT01721057|"     The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily     (QD) is superior to placebo in the treatment of participants with moderately to severely     active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at     least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate     response] participants) and who have not received a biologic disease-modifying antirheumatic     drug (DMARD).   "
119533|NCT01721330|"     The primary aim of this study is to assess whether naltrexone as a monotherapy is effective     in treating ADHD in adults. Medications that increase dopamine are often effective treatments     for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in     the brain. The investigators predict that naltrexone as a monotherapy will be effective for     ADHD symptoms in adults with ADHD.      The investigators also plan to assess the effects of naltrexone on dopamine as measured by     changes in serum prolactin. The investigators predict that naltrexone will increase dopamine     as indexed by decreases in serum prolactin. This study will be a six-week, double-blind,     placebo-controlled pilot study with adults 18-55 years of age with ADHD.   "
119534|NCT01721317|"     This is a Phase IV adjunctive treatment dose-optimization study evaluating the efficacy,     safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892)     compared with placebo in adult subjects with partial-onset seizures (POS). This randomized,     double-blind, placebo-controlled, parallel-group, multicenter study will compare     ezogabine/retigabine IR (investigator-selected daily doses of 600 milligram (mg)/day, 750     mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day) with placebo. Study drug will be taken three     times a day (TID) in equally or unequally divided doses.      The study design includes up to a 10-week (wk) Screening (≤2 wks)/Baseline (8 wks) Phase, a     Titration Phase (2 wks), Dose-Optimization Phase (8 wks), Maintenance Phase (8 wks), and     Taper/Follow-Up Phase (3 wks). The total duration of the study for each subject will be     approximately 31 wks, and at minimum approximately 27 wks if subjects provide reliable 28-day     retrospective seizure data.      Approximately 280 subjects will be screened with approximately 208 subjects randomly assigned     to 1 of 2 treatment groups in a 2:1 ratio (ezogabine/retigabine IR, or placebo).      Subjects will be instructed to start investigational product (IP) the day after the baseline     visit. During the first week of the Titration Phase, subjects will be taking 300 mg/day (100     mg TID). During the second week, subjects will be taking 450 mg/day (150 mg/day TID).      At the beginning of the Dose-Optimization Phase (3rd week of study drug) subjects will take     600 mg/day (200 mg TID) for one week. Thereafter during the Dose-Optimization Phase, subjects     will continue to increase their daily dose by 150 mg per week until they have achieved their     optimal tolerated dose. During this phase, the investigator may choose to have the subject     stay on his/her designated dose for another week before attempting a dose increase until     reaching a dose of 1200 mg/day. In addition, in the context of tolerability issues, the     subject may be reduced to the preceding dose level for one week before attempting to increase     the dose again at the next scheduled time point until the subject reaches optimal dose.     Subjects unable to tolerate a minimum of 600 mg/day will be discontinued from the study.      The Maintenance Phase will begin at Week 10 (Visit 8) and will last 8 weeks. During the     Maintenance Phase, subjects will remain on the daily TID dose achieved at the end of the     Dose-Optimization Phase.      Seizure type and frequency will be monitored throughout the study via a Seizure Calendar and     will be evaluated at each study visit. Subjects will be instructed to complete the daily     Seizure Calendar during each phase of the study.   "
119535|NCT01721304|"     The purpose of this study is to determine if using a computer survey about preferences for     treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient     satisfaction with clinical care and decision making. This study is a two-part study. The     first pilot tests the computerized tool to ensure it is understood by patients, then the     second part is a randomized study (computerized tool versus usual care) to see if     improvements are made in satisfaction and if there are reductions in decision regret.   "
119536|NCT01721291|"     Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties     because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to     provide relief from breathlessness. However, current inhalers are inefficient as they deliver     a 'coarse-mist' of drug-droplets that do not reach the deep airways.      In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive     tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach     the deep airways, and assess if this improves the breathing capacity in our patients. Our     research may allow the development of new, more efficient inhalers to improve treatment for     patients with COPD.   "
119537|NCT01721278|"     Total hip replacement (THR) is a highly effective procedure in relieving pain and restoring     function. Many different implants can be used in artificial hip joints. Hydroxyapatiteceramic     (HAC) coating has become a well established The JRI Furlong® HAC femoral stem is one such     implant with good long term survivorship. The femoral implant has been used since 1985 and     published findings have shown a 97.4% survivorship at a mean of 17 years follow up in     patients. The Furlong Evolution® design is based on the tried and tested Furlong HAC but with     some modifications.      This is a 10 year multicentre clinical surveillance study, which aims to assess the clinical,     functional and radiological performance of the Furlong Evolution® Hip stem in human patients.   "
119538|NCT01721265|"     All subjects in this study have previously been in an Idenix HCV study and received study     drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study     will not be enrolled in this study.      In this study, researchers will try to find answers to these questions:        -  How much (if any) hepatitis C virus is in your blood after stopping your Idenix study          drug?        -  Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or          similar drugs?   "
119539|NCT01721252|"     The aim of this study is to determine prospectively the value of a recently identified     proteomic signature in identifying those patients with lung cancer, who are likely to benefit     from and respond favourably to erlotinib therapy.      This is a prospective study of serum proteomics as a predictor of response to erlotinib     therapy.   "
119540|NCT01721239|"     In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units.     There is evidence to former intensive care patients have a significant symptom burden that     affect recovery, function and activity for up to several years after admission to the     intensive care unit. For the individual patient involves the low quality of life, delayed     recovery, prolonged illness and healing process, and increased mortality. It requires that     health professionals should provide support so patients quicker return to their usual life.     Follow-up interviews with the staff after hospitalization in ICU have been shown to support     the patient and identify individual needs and symptoms that can lead to more realistic     expectations and increased well-being after admission in ICU. Follow-up in Denmark is being     inconsistent in both the number of hospitals that offer this service, and in the offered type     of service. Follow-up interviews with and without diaries suggest to improve physical and     mental well-being and health, with limited scientific evidence of the efficacy of these     interventions. We will investigate the effect of a standardized follow-up program after     admission to the intensive care unit, consisting of written information, patient photos taken     during hospitalization and three follow-up calls compared with standard care (discharge     without follow-up).      During a clinical study conducted in several intensive care units in Denmark examined whether     follow-up calls can improve patients' well-being and health, as well as the meaning of the     follow-up program has on the patient's everyday life in the first year after hospitalization     in the ICU.      The investigation contribute knowledge to the international research by revealing symptom     burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in     order to be able to target rehabilitation efforts and improved the quality of life. It will     be innovative to use the results from a clinical study as a foundation for a database, and     the method can serve as a precedent for evidence-based introduction of guidelines, database     registration and create the groundwork for future research in intensive care. This study is     expected to be profitable to society by preventing frequent readmissions, reduce medication     costs and fewer referrals to specialists and have a positive effect on retention to the labor     market. This will provide overall better use of society's expenses.   "
119541|NCT01721226|"     The purpose of this study is to determine whether an intervention (CARE+ Corrections)     delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and     recently -released ex-detainees in the community can improve linkage to community HIV care     and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral     suppression following community re-entry.   "
119542|NCT01721213|"     As part of a European post-marketing commitment, GSK will conduct a survey of physicians' and     patients' understanding of the significant risks associated with Trobalt™ (retigabine), as     described in the Patient Information Leaflet (PIL) and the Physician's Guide. The goal of the     surveys is to evaluate the effectiveness of the educational plan as specified in the European     Risk Management Plan (RMP).      The objectives of this study are to assess patients' and prescribers' understanding and     knowledge of the significant risks associated with Trobalt™ use as evaluated by a survey     instrument.      This is a cross sectional survey of:        1. 250 patients recruited from across the following countries (United Kingdom, Sweden,          Denmark, Switzerland, Spain, Slovakia and Norway) and up to 100 patients from Germany          who are currently using or have filled a prescription for Trobalt™ at least once in the          last 3 months.        2. 200 neurologists who have prescribed an anti-epileptic drug (AED) at least once in the          last 3 months, and who were on the list to which a letter containing the Physician's          Guide for Trobalt™ was distributed from across the following countries (United Kingdom,          Sweden, Denmark, Switzerland, Spain, Slovakia and Norway). At least 75 of the          neurologists will have prescribed Trobalt™. The survey will also aim to include up to          100 neurologists from Germany of which approximately 50 will have prescribed Trobalt™.      Patients eligible for the survey will be asked to take the survey online or via a telephone     interview if the latter is preferred. Neurologists will be invited to take the survey online.      The selected countries were the first five countries to launch Trobalt™ (Germany, Denmark,     United Kingdom, Switzerland and Sweden) and an additional three countries with launch in     2011, but with relatively high rates of uptake of Trobalt™ (Spain, Slovakia and Norway). The     selection of countries includes Switzerland, which is not part of the European Union.     However, the key messages regarding the risks with Trobalt™ are in alignment. The rationale     for surveying the first five countries to launch is so that any issues identified from these     countries regarding the effectiveness of the Physician's Guide and PIL in communicating the     risks of Trobalt™ can be addressed as soon as possible, and the key messages can be revised     in a timely manner. In addition, these countries are likely to provide the greatest number of     neurologists with experience of prescribing Trobalt™, and their patients.      The primary outcome of the survey is the proportion of patients/neurologists providing     correct responses to a series of questions concerning the significant risks associated with     Trobalt™. The risks evaluated will be those described in the Trobalt™ PIL and in the     Physician's Guide.   "
119543|NCT01721200|"     This study is a randomized controlled trial designed to examine the efficacy of an     educational decision support tool for patients with rheumatoid arthritis who continue to have     active disease despite use of traditional disease modifying drugs. The study will take place     at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by the     treating physician and those providing consent will be randomized to usual care versus use of     the decision support tool.   "
119544|NCT01721187|"     Using fMRI, this study will explore the neural correlates of satiety when individuals make     decisions about food. The investigators will also examine individual differences in satiety     effects.   "
119545|NCT01721174|"     Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct     cancers, and its development can hinder the use of chemotherapy, decrease patient quality of     life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction,     endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs)     have been shown to result in a longer patency times as compared with plastic stents. However,     despite improvements in materials and stent design, stent obstruction still occurs in 13% to     44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.      Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described     in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction.     The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of     the bile duct lumen. The procedure has the potential of reducing the rate of stent     obstruction after SEMS and also prolonging survival. The safety profile appears to be     comparable that of placement of SEMS alone without added complications (<10%). The aim of the     current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in     a randomized controlled trial.We hypothesize that the application of EBRFA can reduce     recurrent biliary obstruction after SEMS.   "
119546|NCT01721161|"     The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with     their first episode of unilateral acute optic neuritis (AON). The secondary objective of this     study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this     study population.   "
119547|NCT01721148|"     There is a great need for new therapies for carcinomas that have progressed on or not     responded to current therapy. There are no approved Met targeted agents in standard clinical     use. In the population of subjects with advanced carcinomas that are unresponsive to standard     of care, and based on the relatively safe, reversible and monitorable toxicity profile of     ASLAN002 in non clinical studies, the potential for benefit from ASLAN002 outweighs the     potential risks for toxicity.      The purpose of this study is to identify the maximum tolerated dose of ASLAN002 in subjects     with advanced or metastatic solid tumours, as well as to define the overall safety profile of     ASLAN002.   "
119941|NCT01715987|"     Nucleotide anti-viral analogues, including adefovir and TDF, have demonstrated kidney     toxicity in HIV/HBV co-infected patients and HBV mono-infected European patients.     Investigators suspected similar kidney proximal tubular injury can also occur in HBV mono     infected Asian patients receiving TDF treatment.   "
119548|NCT01721135|"     This study is a randomized, placebo controlled, four way crossover, in which the the effect     of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course     of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin     400mg (single dose) with a weeks washout prior to starting the next course. Key assessments     include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by     blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events     .   "
119549|NCT01721109|"     This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single     tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.     Safety, tolerability, and efficacy will also be evaluated through Week 48.      A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive     EVG/COBI/FTC/TDF as follows:        -  Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK,          and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and          at least 4 participants 15 to < 18 years of age.        -  Part B: Following confirmation of EVG exposure in at least 12 participants from Part A,          34 to 38 participants in addition to those enrolled in Part A will be enrolled to          evaluate the safety, tolerability and antiviral activity of EVG/COBI/FTC/TDF STR.   "
119550|NCT01721096|"     The objectives of the PMS are to observe the frequency, type, and degree of device deficiency     to assure the safety of the new medical device (XIENCE PRIME) as well as to collect     information on evaluation of the efficacy and safety for reevaluation.   "
119551|NCT01721083|"     This study is designed to compare two different styles of intramuscular injection (Bunch     versus Z-Track)during flu vaccination with the following outcome measures as basis for     comparison: perceive pain, redness, medication leakage, other complications within 72 hours     in healthy adult volunteer subjects.   "
119552|NCT01721070|"     Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following     sublingual administration of sufentanil NanoTab.   "
119555|NCT01721031|"     Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is     defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may     cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve     block (DPNB) was applied for penile surgery including circumcision and some anterior urethra     surgery. The investigators hypothesize that DPNB relive CRBD for male patients with     indwelling urinary catheter under general anesthesia.   "
119556|NCT01721018|"     HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the     RL1 gene which encodes the protein ICP34.5.      Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and     peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to     asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant     pleural mesothelioma forms plaques that are distributed on the surface of the pleural space     in the lung. Approximately 30% of patients require an indwelling pleural catheter for     drainage of pleural effusions. In this patient group, the indwelling catheter may be used to     facilitate loco-regional delivery of HSV1716 to the pleural space.      This study seeks to evaluate the safety and biological effects of single and multiple     administrations of HSV1716 in the treatment of malignant pleural mesothelioma.   "
119557|NCT01721005|"     The aim of this study is to evaluate the feasibility of patient education on feeling the own     pulse irregularity in the elderly population of Lieto.      Prevalence of atrial fibrillation (AF) rises with age. Subjects have often symptoms like     palpitation and discomfort but especially in elderly population there's significant quantity     of persons who don't feel any symptoms and fail to seek for medical care for stroke     prevention.      The main objectives in this study are to find out the prevalence of AF in the elderly     population of Lieto, to assess the feasibility and reability of patient education on feeling     one's pulse irregularity and the affect to the quality of life of the participating subjects     and monitoring the possible increased burden to the public health care system.      The study contains two office visits with specified learning session and long-term phone-call     follow-up.   "
119558|NCT01720992|"     Background: Shamshuipo District has the highest proportion of low income families, and a     relatively large percentage of single parents, elderly, new immigrants among all districts in     Hong Kong (Census and Statistics Department, 2011). In addition to provide these families     substantial support, a campaign to enhance their family well-being is needed.      Aim: This project is conducted to enhance their family relationship as well as family     happiness, health and harmony (3Hs) among families in the Shamshuipo District, through a     community-based intervention programme combined with a planning tool (booklet).      Methods: This project adopts a cluster-randomized controlled design, with the application of     positive psychology concepts as a theoretical framework. A community-based participatory     (CBP) approach, which is an effective way to engage public health researchers and community     members (NGOs, other major stakeholders, and participants), will be used. Both quantitative     and qualitative methods will be used in the evaluation of major outcomes (participants'     family relationship and 3Hs) at different time points throughout the project. Process     evaluation will be performed to evaluate the process of each component of the project.      Procedure: This project will be conducted in three phases.      Phase 1 includes planning, implementation, and evaluation of a training programme for social     workers from the 30 participating NGOs. The social workers will be equipped with the     knowledge and skills of the application of positive psychology as well as logic model. This     phase also includes the launching event to arouse public awareness of the project.      Phase 2 includes designing, delivering, and evaluating 30 community-based intervention     programmes. A planning tool (designed as a booklet) will be distributed to participants of     the intervention group in the form of 'homework assignment' immediate after the intervention     programme; whereas participants of the control group will receive the booklet upon the     completion of the three months follow-up questionnaire assessment. This phase also contains     focus group interviews among participants to collect their experiences, feelings and changes     in families after attending the intervention programme. Focus groups among social workers     will be conducted afterwards to explore their barriers and facilitators in programme     implementation; as well as their personal and/or collective growth in conducting the project.     In-depth interview among community stakeholders will be held to explore the social impact of     the CBPR project, and collect their suggestions for future implementation.      Phase 3 is a dissimilation phase that the Positive Family Education Booklet and Positive     Family Practice Manual will be released. A practice wisdom forum for social workers and     other major stakeholders will also be organized to share their experiences in conducting the     community-based programmes.      Primary hypothesis: Families participated in a community-based programme and received a     toolkit (intervention group) have higher scores in their family relationship and family 3Hs     than families who participated in a community-based programme only (control group).      Secondary hypotheses: (1) Participants' attitudes towards and intention of practising the     suggested behaviours will be increased immediately after their participation in the     community-based intervention programme; (2) Participants' attitudes towards, their intention,     as well as frequency of practising the suggested behaviours will remain higher at 6 weeks and     3 months after the intervention compared to the corresponding figures of pre-intervention     (baseline); (3) Participants' scores of family relationship and 3Hs will be significantly     higher at 6 weeks and 3 months after their participation in the intervention.   "
119559|NCT01720979|"     Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature     suggests a pivotal role for attentional functioning in neurocognitive and behavioural     consequences of paediatric TBI. Limitations of traditional neuropsychological measures of     attentional functioning have interfered with identification of the effect of paediatric TBI     on attentional networks so far. Moreover, the associations between attentional networks,     learning abilities, academic performance and behavioural and emotional problems following     paediatric TBI are yet to be explored.   "
119560|NCT01720966|"     Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion     formation might be reduced by laparoscopic surgery, however sound evidence is lacking.     Colorectal surgery would be a good clinical model to investigate adhesion formation between     open and laparoscopic surgery because of the adhesion formation propensity of colorectal     surgery. However, a randomized controlled study to provide direct evidence is unlikely     because of large numbers of patients needed for such a trial and the difficulty to check for     adhesion formation at second surgery. Therefore we investigate adhesion formation after     laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.      Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic     versus open surgery for colorectal malignancies during liver resection for colorectal     metastases.      Study design: The study is designed as a prospective observational cohort study.      Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for     intended liver resection or radio frequency ablation for liver metastases of a colorectal     malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.      Main study parameters/endpoints:        -  Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site          of the original incision.        -  Secondary endpoints are episodes of bowel obstruction between index surgery and liver          surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of          adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative          complications: enterotomy, seromuscular injury, inadvertent organ injury during          adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: This study is an observational study. The existence of adhesions will be     assessed during laparotomy or laparoscopy for the treatment of liver metastases. The     laparotomy is indicated for medical treatment and should not be enlarged solely for the     assessment of adhesions nor will the operating time be influenced for this purpose.      Adhesions and peroperative complications have to be scored by the operating surgeon during or     directly after surgery. The postoperative complications have to be scored during the     postoperative course by the doctors on the ward. These assessments do not interfere with the     treatment of the patients.   "
119625|NCT01720121|"     This study is randomized clinical trial to verify the effect of nursing guidelines for     patients undergoing left cardiac catheterization on an outpatient basis. Comparing three     approaches to direct guidelines about the procedure:        -  printed,        -  digital video disc (DVD)        -  conventional guidelines provide by nursing team   "
119561|NCT01720953|"     Purpose:      Borderline personality disorder (BPD) is a complex psychiatric disease of uncertain aetiology     and pathogenesis. A key mechanism of disease susceptibility and treatment response could be     epigenetic changes in DNA methylation patterns. However, no study has yet demonstrated that     psychotherapy can exert its therapeutic effect through epigenetic mechanisms. The main aim of     this study is to analyze the promoter methylation pattern of genes considered to be related     to the development and psychopathology of BPD, in particular the brain-derived neurotrophic     factor (BDNF) and glucocorticoid receptor genes, and the effects of mentalization based     treatment (MBT) on changes. Associations to changes in BDNF serum levels and salivary     cortisol levels, as well as key components of BPD aetiology and core treatment targets in     MBT, will also be investigated. Should epigenetic mechanisms have importance for BPD     pathology and effects of treatment, there is potential use of DNA methylation patterns as     valid biomarker measures of diagnosis, prognosis, and treatment response.      Hypothesis:      The formation and maintenance of symptoms in BPD is mediated through neuropsychiatric     mechanisms that can be affected through psychological treatment. Specifically, aberrant     epigenetic regulation of neuropsychiatric genes related to behavioural control and affect     regulation, as well as BDNF and cortisol levels, is ameliorated by therapeutic processes.      Method:      Fifty female patients diagnosed with BPD will undergo a year of intensive MBT that is     designed to target domains of BPD pathology. The patients will be assessed at baseline and     every 6 months over the treatment period. Matched healthy control subjects will be assessed     at 6 month intervals to compare changes in DNA methylation, BDNF serum levels, salivary     cortisol levels, and neuropsychological test performance. To link components of the     neuropsychiatric mechanisms underlying the onset of illness, course, and response to     treatment, patients will undergo assessment of clinical symptoms, comorbidity patterns and     psychosocial impairment. Patients and control subjects will at baseline undergo assessment     for childhood trauma, self-harm, suicidal behavior, early maladaptive schemas, and     personality traits, and within the 1-year study period also undergo continuous assessment for     changes in symptoms of dissociation, depression, and personality dysfunction.   "
119562|NCT01720940|"     This study is being carried out to find out whether there is reduction in vancomycin-induced     kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous     infusion.      This study will recruit 220 subjects from 2 hospitals over a period of 3 years.      Participants are invited if they have an infection that requires prolonged vancomycin therapy     (> more than 10 days).   "
119563|NCT01720927|"     GABHS are common etiological agents for acute pharyngitis. However, local data is limited and     large scale surveillance studies have not been done. This study aims to evaluate the disease     burden in the community due to GABHS.      In this study, patients presenting with signs of acute pharyngitis will be evaluated.     Patients with fulfilling the inclusion criteria will be tested for Rapid Antigen Detection     test (RADT)   "
119600|NCT01720446|"     This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and     other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is     event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the     accrual of major adverse cardiovascular events (MACE) in this trial and the remaining     research programme. The incidence of MACE will be monitored throughout the trial which will     be terminated according to plan when pre-specified stopping criteria are met.   "
119564|NCT01720914|"     In this prospective, multicenter observational study we assess the diagnostic validity of the     following standard screening instruments for delirium regarding sedation, analgesia and     ventilator status in critically ill patients:        -  Confusion Assessment Method for the ICU (CAM-ICU)        -  Intensive Care Delirium Screening Checklist (ICDSC)        -  Nursing-Delirium-Screening-Scale (Nu-DESC)      The definite delirium diagnosis (definite in terms of reference standard) is made according     to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition,     text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the     Gold Standard to diagnose delirium.      Primary research question: Does sedation, ventilator status and analgesia influence the     sensitivity of delirium screening tools (DST)?   "
119565|NCT01720901|"     To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients     who progressed after gefitinib therapy.   "
119566|NCT01720888|"     Despite the recent advances in medical and surgical treatment, heart failure resulting from     ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality. Ischemic     dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity     with documented poor LV function as a result of severe coronary artery disease (CAD). LV     remodelling which is inevitable after an infarct has been postulated to contribute largely to     the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for     the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic     strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem     cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow.This study aims     to test the differentiation potential and therapeutic capacity of MSC from severe CAD     patients after intracoronary implantation in an ischemic myocardial environment in Malaysian     population.   "
119567|NCT01720875|"     Bortezomib is an established treatment in multiple myeloma; it is common practice in the UK     to administer bortezomib with dexamethasone. This practice is based on data that supports     improved response rates with this combination.      Recent trial data indicates that the addition of vorinostat to bortezomib treatment overcomes     treatment resistance to bortezomib. As such this current trial is designed to investigate the     efficacy, safety and tolerability of combination treatment with vorinostat, bortezomib and     dexamethasone in patients with relapsed and relapsed refractory myeloma.      A comparison of this Phase II trial with the pivotal Phase III trial conducted by MSD (using     the labelled bortezomib indication without dexamethasone) will address the impact of     dexamethasone in regards to tolerability and additional efficacy in myeloma patients.   "
119568|NCT01720862|"     This research is being done to look at the association between migraine and obesity.   "
119569|NCT01720849|"     The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue,     micturation and walking impairment under 3 months of Fampyra treatment   "
119570|NCT01720836|"     All subjects will receive the vaccine subcutaneously every 3 weeks x 3 and then every 3     months for 3 years. The rationale for using Poly-ICLC as an adjuvant are two ongoing trials     at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one     as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and     the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The     same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There     has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the     proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.   "
119626|NCT01720108|"     In this study the investigators want to look at whether using aspirin instead of rivaroxaban     (after initial treatment with rivaroxaban) works as well at preventing blood clots while also     reducing risk of bleeding and is more cost effective in patients who have either a total hip     replacement or total knee replacement.   "
119571|NCT01720823|"     It is often clinically impossible to differentiate children with an isolated snoring from     those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based     polysomnography. This expensive examination is poorly accessible due to appointments delays     at hospital.      Our study is designed to compare the characteristics of a home polysomnography versus     standard polysomnography for the diagnosis of pediatric OSA.   "
119572|NCT01720810|"     This study evaluates cognitive impairment in subjects with Parkinson disease (PD) and similar     neurological disorder through obtaining longitudinal clinical and neuropsychological data.     The long term goal is to have a well-characterized subject population to contribute to our     understanding of the natural history, diagnosis and ultimate treatment of cognitive     impairment in patients with PD and similar disorders.   "
119573|NCT01720797|"     The purpose of this research study is to assess the clinical effectiveness of the procedure     of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth     movement in patients undergoing orthodontic treatment. Accelerated tooth movement means     that using the PROPEL™ device may help complete your treatment with braces on one side of     your mouth sooner than would be expected if the device were not to be used.   "
119574|NCT01720784|"     Studies report that dietary fiber intake is inversely correlated with body weight gain.     Previously, we have shown alginate fiber supplementation increases weight loss, which we     ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One     property of importance to appetite is the ability of alginate to gel in the acidic     environment of the stomach. We hypothesize that the alginate will decrease the feeling of     hunger and lower food consumption compared to control.      Here we test three different beverages in a double-blinded crossover design, in which 24     participants will be randomly assigned to the sequence of the test days separated by at least     5 days.      On each test day appetite sensation as well as blood glucose and insulin will be measured     over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta     Bolognese will be served, and energy intake calculated. The participants will also rate     gastrointestinal confort.   "
119575|NCT01720771|"     The aim of the prospective project is to investigate effect of daily probiotic supplements on     dental caries development in preschool children living in a low socioeconomic immigrant area     in souithern Sweden. The study design is a randomised controlled trial with two parallell     arms. The intervention is one probiotic tablet or placebo once daily. The null hypothesis is     that the caries experience and increment will not differ betwwen the two groups.   "
119763|NCT01718301|"     The primary objective of this study is to evaluate the safety and efficacy of a Response     Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination     with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected     patients that failed to previous HCV therapy.   "
119576|NCT01720758|"     The presence of a specific mutation in the gene known as B-RAF has been found in patients who     have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be     ascertained in peripheral blood samples of patients who have this disease and in a group of     patients who have a similar chronic lymphoproliferative conditions such as splenic marginal     lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis     of Hairy Cell Leukemia and determine whether patients are in remission.   "
119577|NCT01720745|"     ROLE OF SUCTION IN EUS-FNA: Current suction technique involves suctioning the aspirate into     the needle that has an air column. The needle is not flushed with any liquid prior to passing     into the desired solid lesion. Suction is applied when the needle is within the lesion     leading to aspiration of tissue into the needle. This is the standard technique and some have     done with and without the stylet. There are some data that favor non use of a stylet.      WET SCTION TECHNIQUE:      Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the     column of air with saline. The needle is now passed into the desired lesion. Suction is     applied at maximal strength and needle moved back and forth within the lesion to obtain as     aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves     into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a     stylet and or flushing air into the needle with a syringe.      HYPOTHESIS The effect of suction for the purpose of aspirating cells and / or tissue during     fine needle biopsy may be significantly improved by filling the column of the needle with a     less compressible fluid. The volume of vacuum being pulled may be negatively impacted by the     expansion of air within the needle. Replacing the air with sterile saline may thus improve     the suction transferred to the needle tip by ensuring that the full volume of the vacuum     syringe is transferred to the distal tip of the needle. This effect would be most pronounced     in larger gauge needles which would have a larger internal volume. An additional benefit of     filling the needle with saline prior to aspiration is the speed of the pressure transfer. The     theory is that the air in the needle may absorb some of the force of the sudden application     of vacuum. A column of saline in the needle may increase the velocity of the pressure     transfer providing more tissue and less blood.   "
119578|NCT01720732|"     Evaluation of a short version of Narrative Exposure Therapy   "
119579|NCT01720719|"     The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E 300mg     qd therapy on liver fat content in patients with type 2 diabetes associated with high LDL-C     and non-alcoholic fatty liver disease.   "
119580|NCT01720706|"     This is a clinical research study designed to determine the safety and efficacy of the     application of a unique interstitial radio frequency thermal therapy for the treatment of     large tumours in the kidney or liver. The novel device offers patients a more effective     therapy than conventional RFA and for patients with large tumours fewer number of treatments     and needle insertion sites. The clinical treatment volumes (or sites of focal tumours) will     be determined by a combination of biopsy and contrast enhanced CT imaging.      The study will assess if novel device can produce lesions in the liver or kidney in a     controlled and predictable manner and with sufficient size to effectively manage disease     progression in the organ. The extent of lesion size at a delivered power setting and     treatment time will be measured with post-treatment CT or MRI and biopsy as measures of     tissue response   "
119581|NCT01720693|"     Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the     standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies,     partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared     with the standard radical nephrectomy over the short and long term (2, 3). Partial     nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar     clamping, which creates the desired bloodless operative field, allowing for more precise     tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic     kidney injury which can compromise the functional outcomes of the remaining kidney.We are     working now to develop a novel technique of Hypo-Perfusion by achieving partial renal     arterial clamping, with the goal of completely eliminating surgical ischemia to the renal     remnant.   "
119582|NCT01720680|"     -  Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore®          device on central and peripheral airway dimensions in patients with COPD.        -  Indication: COPD patients        -  Study Design: Open-label, prospective design        -  Study Phase: II        -  Test treatment duration: 1 day        -  Test treatment: AlphaCore® device        -  Dosage regimen: 1 session of stimulation during 90 seconds        -  Patient number: up to 10 evaluable patients with COPD        -  Patient age: ≥ 18 years        -  Sex: male or female        -  Primary objective: The evaluation of the effect of the AlphaCore® device on central and          peripheral airway dimensions with Computational Fluid Dynamics (CFD).        -  Secondary objectives: The assessment of the effect of the AlphaCore® device on lung          function (spirometry, diffusion and resistance) and on patient reported outcomes          (PRO`s).   "
119583|NCT01720667|"     A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants.     Current treatments for the brain damaging complication of neonatal seizures are     unsatisfactory.      Monitoring for seizure detection will be tested at five (5) US sites and one (1)     international site using the internet.   "
119584|NCT01720654|"     Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent     gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for     use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner     management with heterosexual patients, but note the absence of evidence necessary to make an     equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess     the impact of EPT on partner notification, treatment, and STI re-infection among MSM are     critical to the development of evidence-based partner management guidelines.      Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and     chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that     frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may     be a factor contributing to the persistently high incidence of HIV infection among MSM in the     region. The investigators propose a pilot evaluation of the effect of EPT on partner     notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any     anatomic site.      Specific Aim 1: To explore the social norms and structural factors influencing partner     notification and treatment among MSM in Peru.      Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification     among MSM diagnosed with gonorrhea or chlamydia infection.      Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial     re-infection among MSM randomized to receive EPT compared with standard partner notification     counseling.      The proposed study will provide pilot data on the use of EPT with MSM diagnosed with     gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as     an STI control method among MSM in Latin America.   "
119601|NCT01720433|"     Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as     causes of post-operative morbidity. This prospective, double-blind, randomized controlled     trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by     implementing a simple intra-operative technique.      Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or     laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be     randomized to either the current standard (control group) or to receive an intervention to     remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the     end of the operation, by placing the patient in the Trendelenburg position and utilising a     pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of     60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of     the procedure by passive decompression via the open operative ports.   "
119585|NCT01720641|"     The goal of the proposed research is to assess new strategies for partner management and     sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have     sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the     core risk group of MSM. STI infection and re-infection are central to the continuation of the     HIV epidemic among MSM in Peru. Development of improved strategies for partner notification     and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the     incidence of HIV infection in this population. The first phase of this study used qualitative     methods to explore attitudes and practices related to partner notification among MSM in Lima,     Peru. Findings from the qualitative research were used to develop a quantitative survey     instrument to assess partner notification decision-making processes and practices among MSM     in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and     qualitative phases of the study have been used to develop a partner notification for MSM in     Peru. Investigators plan to implement and assess the impact of the intervention on rates of     partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The     investigators hypothesize that participants randomized to receive one or more partner     notification tools will report a higher frequency of partner notification.   "
119586|NCT01720628|"     Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial     dysfunction plays a prominent role in the pathogenesis of the disease, we considered     angiogenic cytokines as an interesting target for investigation in BD. The aim of this study     was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF)     and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.      Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included     in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in     vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.   "
119587|NCT01720615|"     The objective of the present investigation is to analyze EEG and auditory evoked potentials     at the transition from consciousness to unconsciousness and vice versa. A set of     electroencephalographic and auditory evoked potential parameters should be identified that     allows separation of consciousness from unconsciousness (reflected by     responsiveness/unresponsiveness to command). The study is based on data of 80 patients     undergoing general anesthesia with remifentanil and either sevoflurane or propofol.   "
119588|NCT01720602|"     This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer     receiving hormone therapy. Vorinostat may help hormone therapy work better by making tumor     cells more sensitive to the drug.   "
119589|NCT01720589|"     The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich     in medium chain triglycerides on energy expenditure and food intake in overweight and obese     children.   "
119590|NCT01720576|"     This is a study to assess the safety and tolerability of subcutaneously administered REGN1033     (SAR391786) in healthy volunteers.   "
119627|NCT01720095|"     The purpose of this study is to help understand if by adding Niaspan FCT (study drug) to     antipsychotic medications will it help maintain or improve cognitve functioning.   "
121186|NCT01699737|"     The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to     assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients     either treated with metformin or treatment-naïve.   "
119591|NCT01720563|"     Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were     betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization     (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was     higher than the 8-11% reported in the Western populations and was related to oral submucous     fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in     patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with     cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in     stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced     myelosuppression. It also improved the Quality of Life, especially in fatigue, among advanced     cancer patients. This study will be investigated the effect of PG2 Injection in relieving the     adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis,     body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of     patients with advanced pharyngeal or laryngeal SCCHN.   "
119592|NCT01720550|"     The objective of this study is to conduct a trial in the spirit of providing as much as     possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and     safety of different doses of PG2 treatment for relieving fatigue among advanced cancer     patients who are under standard palliative care (SPC) at hospice setting and have no further     curative options available. Patient's fatigue status, to be measured by the Brief Fatigue     Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement     response rate among patients between two study arms will then be compared as the basis for     efficacy evaluation at the end of the first treatment cycle, and will be the primary     endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores     change from baseline among patients within and between cycles will be included in the     secondary efficacy endpoints, and will be compared between two study arms. Patients' quality     of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be     also measured by 11 questions (SS11) from EORTC(European Organization) for Research and     Treatment of Cancer QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints     include Karnofsky performance scores, and weight change and its related c-reactive protein     level of the patients.   "
119593|NCT01720537|"     This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or     multiple fixed subcutaneous and intravenous administrations of PF 05335810 to     hypercholesterolemic subjects when added on to a daily statin dose.   "
119594|NCT01720524|"     This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide     treatment and reduce the failure rate of available treatments for persistent pulmonary     hypertension of the newborn.   "
119595|NCT01720511|"     This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and     insulin. The purple color is due, like red wine grapes, mainly to the anthocyanins. The     safety and tolerability of purple rice is similar to white or brown rice, but contains the     purple elements common to other foods like grapes.   "
119596|NCT01720498|"     To find out the effect site concentration of remifentanil for preventing QTc interval     prolongation during intubation under propofol-remifentanil anesthesia in elderly patients   "
119597|NCT01720485|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drug associations in the treatment of Moderate - Severe Persistent Allergic     Rhinitis in Adults.   "
119603|NCT01720407|"     Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on     photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to     Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although     surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10     mm) excision for a localized tumor on the face.      Several studies have shown that imiquimod, activating local immunity by interferon     production, induced LM or MLM regression and could also decrease the frequency of relapses.      The principal aim of our project is to study the effect of imiquimod versus placebo in     pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the     first surgical procedure, and the frequency of short and medium term recurrence of LM.     Furthermore, the improvement in patient quality of life could also be significant.   "
119604|NCT01720394|"     The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter     for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not     greater than 6) compared to medical treatment using a dinoprostone     slow-release-vaginal-insert.   "
119605|NCT01720381|"     The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels     in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000,     the reference standard for Erasme University Hospital.   "
119606|NCT01720368|"     The investigators believe that patients with Crohn's disease are able to report details of     their own medical history accurately and record changes in clinical status effectively over     time. Using an internet-based database the investigators will ask patients to report their     own disease history, and the investigators will compare their reports to the medical record.   "
119607|NCT01720355|"     Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse     subject population during severe signal interference over a specified saturation range.   "
119608|NCT01720342|"     The EASE Enable study is intended to collect additional data on the clinical outcomes of the     Medtronic Enable® Aortic Bioprosthesis in real world patients.   "
119609|NCT01720329|"     The goal of this study is to assess the feasibility of randomizing residents of long-term     care facilities to either probiotics or placebo to assess whether probiotics can reduce     influenza and other viral laboratory confirmed respiratory infection.   "
119628|NCT01720082|"     Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women     affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this     subgroup is high. Since the dissemination of single access surgery (no-scars surgery)     ameliorated outcome has been supposed in these patients regarding post-operative pain,     hospital stay and cosmetics results, and keeping the same safety as LA. This randomized     controlled study is supposed to give answers to these questions.   "
121187|NCT01699685|"     The study purpose is to evaluate the effect of QAB149        -  NVA237 vs. QAB149 on static lung hyperinflation.   "
119610|NCT01720316|"     The purpose of this study is to assess the efficacy of oral glycine as an augmentation     strategy in two psychotic patients with a triplication (4 copies) of the gene glycine     decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical     trial in which one 6-week arm will involve glycine (maximum daily dose of 0.8 g/kg,     administered on a TID dosing schedule) and one 6-week arm will involve placebo. A 2-week     period of no treatment will occur between treatment arms. A 6-week period of open-label     glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) will follow     the double-blind placebo-controlled clinical trial. Prior to the double-blind     placebo-controlled clinical trial and at the end of the open-label glycine trial, the     following procedures will be carried out: structural MRI (3T), Proton 1H MRS (4T), fMRI (3T),     steady-state visual evoked potentials, and EEG. Positive, negative, and affective symptoms     and neurocognitive function as well as plasma levels of large neutral and large and small     neutral and excitatory amino acids and psychotropic drug levels will be assessed     periodically. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a     glycine-containing drink will be assessed at baseline. Pharmaceutical grade glycine powder     (Ajinomoto) or placebo will be dissolved in 20% solution and prepared by the McLean Hospital     Pharmacy.      Because the results of the double-blind placebo-controlled and open-label glycine treatment     arms showed substantial clinical benefit to the participants, the study has been extended to     include six months of chronic open-label glycine in order to determine 1) whether the     clinical benefits achieved within 6 weeks previously recur, 2) the clinical benefits are     lasting, and 3) additional clinical benefits occur with longer exposure. The glycine for this     extension will be provided by Letco Medical.      The investigators hypothesize that mutation carriers will have reduced endogenous brain     glycine and GABA levels and increased brain glutamate and glutamine levels. Glycine     administration will increase brain glycine in the two carriers, but to a lesser extent than     in non-carrier family members and controls.      The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs     modulated by NMDA in mutation carriers compared with non-carrier family members and controls.      The investigators hypothesize that glycine, but not placebo, will improve positive, negative     and affective symptoms as well as neurocognitive function.      The investigators also hypothesize that open-label glycine will improve clinical and     cognitive functioning, will partially normalize decreased baseline glycine and GABA and     increased glutamate and glutamine, and will partially normalize magnocellular pathway     activation and abnormal evoked potentials.   "
119611|NCT01720303|"     This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug     (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately     controlled on the current OAD therapy.   "
119612|NCT01720290|"     This trial is conducted in Asia. The aim of this trial is to compare repaglinide and     metformin administered alone or in combination in subjects with type 2 diabetes.   "
119613|NCT01720277|"     The purpose of this pilot evaluation is to help determine the feasibility and power needed to     prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing     influenza mortality and hospitalization in a nursing home population in the U.S., compared to     the standard dose influenza vaccine.   "
119614|NCT01720264|"     The main purpose of this trial is to assess the efficacy and safety of sitagliptin in     enhancing engraftment following umbilical cord blood transplantation (recovery of blood     counts after transplant).   "
119615|NCT01720251|"     The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal     treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic     rhinoconjunctivitis during the following birch pollen season   "
119616|NCT01720238|"     Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased,     patients who had been chronically infected with HBV, especially those with liver cirrhosis     cause great burden on public health care. In view of economic development level, drug     availability and lack of independent health economics evidence, the investigators are still     unable to give specific guidelines for HBV related compensated liver cirrhosis in China.     Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of     two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through     this prospective, open-label, multicenter and nonrandomized study.   "
119617|NCT01720225|"     The goal of this clinical research study is to compare how two different drugs, decitabine     and azacitidine, when given on a shorter than standard dosing schedule can help to control     MDS. The safety of the drugs will also be studied.      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause     cancer cells to die.      Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the     function of the tumor-fighting proteins. By blocking the bad proteins, the tumor-fighting     genes may be able to work better. This could cause the cancer cells to die.   "
119618|NCT01720212|"     To evaluate the safety and plasma concentration change of YM178 after single- and     repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.   "
119620|NCT01720186|"     This is a pilot study, single-center, prospective, open-label, to assess the acceptability     and performance of the experimental medical device (SPI) used during an imaging examination     (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its     own control, since the imaging examination will be synchronized simultaneously with the two     systems: tested Medical Device (SPI) and reference Medical Device(RPM).   "
119621|NCT01720173|"     This phase II trial studies the side effects and how well dalantercept works in treating     patients with ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that     has returned. Dalantercept may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Dalantercept may also stop the growth of tumor cells by blocking     blood flow to the tumor.   "
119622|NCT01720160|"     The purpose of this research study is to show whether the Neo system is safe and works in     people with heart failure. The study is currently in long-term follow up.   "
119623|NCT01720147|"     Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone     marrow failure (BMF), congenital abnormalities and a predisposition to malignancy.   "
119624|NCT01720134|"     Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high     cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive     Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher     than the 1% after natural conception, related to the number of embryos transferred, and     preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART     cycles are reimbursed for female patients younger than 43 with a Belgian insurance number     since July 2003, but only if a limited number of embryos is transferred depending on female     age and cycle rank. Although this policy has resulted in a significant reduction in the MPR     after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if     the cumulative delivery rate per patient is affected by this legislation. The aim of this     study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab     reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when     compared to the situation before 2003.   "
119660|NCT01719653|"     The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and     SUPREP to see which preparation cleanses the colon best and which preparation is best     tolerated.   "
119629|NCT01720069|"     To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using     oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily     regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent     asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative     for Asthma (GINA) guidelines 2011.   "
119630|NCT01720056|"     Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard     treatment is yet to be clarified. This randomized clinical pilot study will compare the     effects of two local treatments for preventing keloid recurrence after surgical removal;     steroid and verapamil.      Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal     treatment efficacy as steroid injection.   "
119631|NCT01720043|"     To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours     after infusion in patients with multiple myeloma   "
119632|NCT01720030|"     We hypothesise that levosimendan will have a positive influence on renal function during     acute kidney injury in adult intensive care patients.   "
119633|NCT01720017|"     The overall purpose of this study is to assess the impact of preclinical airway manikin     training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway     conditions (c-collar and swollen tongue) on the clinical learning curve of using the     device/system in airways with predictors for difficult intubation.      The investigators hypothesize that the clinical learning curve in airways with predictors for     difficult intubation will be shorter for study subjects (operators) who undergo preclinical     manikin training under simulated difficult airway conditions compared to Study subjects     (operators) who do not receive this training. The clinical learning curve is characterized by     procedure times and first attempt success rates on successive uses of the Airtraq Avant and     Wireless Monitor System in patients with at least one predictor for difficult intubation.   "
119634|NCT01720004|"     The investigators designed a pilot randomized controlled trial to assess the feasibility and     acceptability of repeated hands-and-knees positioning during labour. The objectives were 1)     to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol     by participants and care providers, 3) to obtain women's views about their experiences using     the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the     sample size calculation for a large trial.   "
119635|NCT01719991|"     The purpose of this study is to implement a pragmatic intervention in four (4) family     medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients     with chronic diseases.   "
119764|NCT01718288|"     Evaluate the possibility of optimization of therapy with prostanoids (iloprost), in patients     with Fontaine's stage IIb severe chronic ischemia, both in patients eligible for surgery both     in patients for which it is only possible medical therapy   "
119636|NCT01719978|"     Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used     as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical     efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more     dangerous LA, especially in patients with increased cardiovascular risk. There is scarce     clinical data about the safety of the use of hyaluronidase in dental procedures.      This study aimed to compare hemodynamic and electrocardiographic variables during a dental     surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in     healthy subjects.   "
119637|NCT01719965|"     A popular form of community engagement is for the researchers to interact with a Community     Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border     for many years and has been informally engaging with the community for its healthcare and     research initiatives, especially in the area of ethics and consent. In January 2009,     community engagement was formalised with the establishment of the Tak Province Border     Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the     investigators have not come across any set up of similar nature involving mobile and unstable     populations residing along a porous border.      Three years on, SMRU questions if the T-CAB has been successful and if the current T-CAB     model is the best model for this community. In order to evaluate the T-CAB, first an     evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,     then the evaluation will be carried out.   "
119638|NCT01719952|"     A double-blinded randomised control trial conducted in the Department of Obstetrics and     Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for     two years duration from January 1st, 2012 till December 31st, 2013.      The aim of the study is to compare the haemodynamic and cardiovascular effects between     intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective     Lower Segment Caesarean Section (EL LSCS).      Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly     safe and has similar efficacy in comparison to a single injection of oxytocin.   "
119639|NCT01719926|"     Mesenchymal stem cells (MSCs) are present in the circulation of cancer patients, and are     recruited to the stroma of both the primary tumor and metastasis. Recent preclinical research     has shown that in response to platinum-based chemotherapy, MSCs secrete two specific     platinum-induced fatty acids (PIFAs) which induce resistance to a broad spectrum of     chemotherapies. The secreted PIFAs are the fatty acid oxo-heptadecatetraenoic acid (KHT) and     the omega-3 fatty acid hexadecatetraenoic acid (16:4). These PIFAs are produced via the COX-1     pathway. COX inhibitors, including indomethacin. This phase 1 study explores the safety of     combining indomethacin with platinum containing chemotherapy.   "
119640|NCT01719913|"     Objective: To identify how specific changes of the gluten content in the diet affect the     host-gut microbiome interactions with implications for metabolic health.      Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of     two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60     participants will be included.      Intervention: low vs high gluten intake.   "
119641|NCT01719900|"     The recent dramatic increase in obesity has been linked to a reduction of dietary fibre     intake. We hypothesized that supplementing the diet of overweight and obesity adults with     pulse fibre will improve their metabolic status, chiefly defined as greater weight loss.     Other metabolic health improvements may include improved glucose control and reduced     inflammatory markers.   "
119642|NCT01719887|"     Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures.     These fractures have historically been treated mainly conservatively with good results.     Recent development in fracture treatment and findings that certain fracture types are more     prone to non-union and bracing-related functional problems of adjacent joints are somewhat     common have caused increasing interest in treating these fractures surgically. Return to     activities is also considered to be quicker among surgically treated patients.      The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical     treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who     are willing to participate in the study after informed consent are randomly assigned to two     different treatment methods:        1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking          plate.        2. Conservative treatment with functional bracing      The randomization is done using blocked randomization (block sizes are not known by the     enrolling or assigning phycisian) and stratification is done according to fracture type     (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no     palsy).      Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits     are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and     clinical and radiological assessments are made. The physiotherapist doing objective     functional measurements is blinded to treatment method. Both study groups receive     physiotherapy after the initial treatment.   "
119643|NCT01719874|"     The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy     adult volunteers that have been inoculated with the influenza A virus   "
119644|NCT01719861|"     Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer     (SCLC) and other high-grade neuroendocrine tumors.   "
119645|NCT01719848|"     Failure of advanced airway security has been reported that it could lead lethal complication     such as brain hypoxic damage. There have been controversial reports for the airway assessment     tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity     of pre-existing airway assessment tests and scoring system using a gray zone approach in     patients undergoing general anesthesia required endotracheal intubation.   "
119646|NCT01719835|"     This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental     arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will     be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.   "
119765|NCT01718275|"     The purpose of this study is to determine the feasibility of non-operative management of     early appendicitis in children. We hypothesize that non-operative management of early     appendicitis in children with antibiotics alone will be successful in 80% of children at 1     year follow-up.   "
119647|NCT01719822|"     Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who     perform regular physical activity, have improved health and wellbeing compared with those who     do little exercise. The purpose of the study is to evaluate whether the use of a simple     pedometer (step counter) to set targets for daily physical activity can encourage COPD     patients referred for an 8-week pulmonary exercise based programme (PR) to be more active.     The investigators also want to know whether the use of pedometers during PR can improve     adherence, self-management and outcome in COPD.   "
119648|NCT01719809|"     This is a prospective, observational, single-center study. Patients with at least 3 months of     experience using topical medications for glaucoma and who state that they administer their     own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial     eye drop, will be identified at the time of a regularly scheduled exam. If the patient can     get a drop onto the eye and also not touch their lids or ocular surface with the eye drop     bottle, the subject will be thanked but not enrolled. All other patients who agree to     participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each     enrolled patient will be shown a video demonstrating an instillation technique and will be     given an instructional handout highlighting a proper drop instillation technique. If     necessary, an instillation technique will be demonstrated to them by an investigator or     trained personnel.      A patient will be identified as properly instilling a drop if they satisfy the following     criteia:      They are able to instill one (and only one) drop to the ocular surface or lower fornix     without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.      All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the     investigator or trained personnel would direct the patient to instill an eye drop into the     study eye.Additionally, the short glaucoma self-efficacy questionnaire will be     re-administered.      All of the video-recordings of participants' eye drop instillation techniques will be     reviewed and assessed using a standard checklist. Their ability to administer an eye drop     after training will be compared to baseline.   "
119649|NCT01719796|"     Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment.     Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The     investigators hypothesized bilateral continuous transverse abdominal plan block would reduce     ventilatory impairment following abdominal surgery.   "
119650|NCT01719783|"     To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133     (H5N2) in healthy adults.   "
119661|NCT01719640|"     Central nervous system (CNS) injury leads to morbidity in patients, which has few good     rehabilitation measures. Mesenchymal stem cells seem to have regenerative and     tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem     cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by     recording the change of nervous system scores, trying to prove the effect of MSC in     rehabilitate CNS injury.   "
119662|NCT01719627|"     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of     antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential     of MVC as a on demand pre-exposure prophylaxis, within a strategy for the prevention of HIV     infection in men who have sex with men (MSM).   "
119663|NCT01719614|"     The purpose of the study is to evaluate the effect of steady-state (constant concentration of     medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is     absorbed in the body, distributed within the body, and removed from the body) of a single     dose of metformin, over time, in healthy adult participants.   "
119651|NCT01719770|"     Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers     are in use, together with analgesia and sedation, during the cooling process in many centers     to prevent shivering. Since neuromuscular blockers are accused to be associated with various     side effects causing serious harm and/or leading to prolong ICU stay. So economical use seems     to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic activity.     Therefore, post hypoxic seizures might remain undetected.      Aim of this study is to investigate if a continuous application of neuromuscular blockers is     necessary to prevent shivering and thereby avoid the counter regulation to achieve the target     temperature as soon as possible in mild hypothermic therapy after cardiac arrest.      A single center (university hospital) study. Randomized, double blinded, double dummy study     design. Eligible are all adult patients after successful resuscitation due to cardiac arrest     of presumed cardiac origin.      All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed     cardiopulmonary origin will be included.      Patients <18 years, cardiac arrest >6 hours before admittance at the hospital, patients with     known or clinically apparent pregnancy, patients who reach our hospital with a body     temperature below 35°C, patients with known allergic reactions against rocuronium, patients     with a history of myasthenia gravis, patients with obvious intoxication, wards of the     state/prisoners and patients with known epileptic disease will be excluded.      Primary outcome:      Shivering episodes will be scored with the Shivering Assessment Scale.      Secondary outcome:      Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and     total energy needed during the cooling period will be compared between the two groups.      Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum     levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.      Train-of-four will be performed to assess the depth of relaxation. Sedation will be monitored     via bispectral index; measurement of metabolic activity will be evaluated using indirect     calorimetry. Additionally, EEG will be performed to detect epileptiform activities. Blood     will be drawn to measure levels of midazolam, fentanyl and rocuronium.   "
119652|NCT01719757|"     The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to     Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under     conditions of daily practice.   "
119653|NCT01719744|"     This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue     sarcoma. This study will help to understand how well ENMD-2076 works and how safe and     tolerable the drug is in this patient population.   "
119654|NCT01719731|"     Recent research suggests that BPD is a common, serious but treatable disorder with a better     than previously recognized prognosis. Despite these findings, many patients with BPD are not     given the borderline diagnosis by the mental health professionals treating them. It is also     true that many newly diagnosed borderline patients are not provided with up-to-date     information on the disorder even though psychoeducation has been found to be a useful form of     treatment for other serious psychiatric illnesses.      The investigators have conducted a preliminary randomized trial of psychoeducation for BPD     that found that those provided with immediate psychoeducation had a significantly greater     reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than     those with delayed psychoeducation.      However, both instruction and assessment of change over time were conducted in person by     paraprofessionals. The importance of the current study is that it will allow the     investigators to develop and test the efficacy of an internet-based program of     psychoeducation for BPD that will be both cost efficient and easy to disseminate widely,     particularly to underserved populations.   "
119655|NCT01719718|"     A multicenter prospective randomized controlled trial comparing closure versus non-closure of     the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in     laparoscopic ventral hernia repair.   "
119677|NCT01719432|"     Studies have shown that different percentages of body fat can alter the way drugs are     distributed in the body. This study will use blood samples taken at different time points for     patients taking Neupogen to determine if higher body weights affect drug exposure. The     information gathered from this study will help understand if patients with higher body     weights need a different dosing plan.      Patients in this study will have blood draws once before they take Neupogen and 6 times after     they take the Neuopen (for a total of 24 hours). These patients will be in the hospital     already and will not need to make additional trips back to have blood drawn. A total of about     5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched,     non-obese patients will be enrolled into this study.   "
119678|NCT01719419|"     The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the     taste for fat in humans.   "
119656|NCT01719705|"     Post-cesarean pain management is essential for early mobilization of the mother so that she     becomes able to care of her newborn. There choices for postoperative analgesia include     spinal, systemic, or both opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local     anesthetic infiltrations of the wound, or transverse abdominis plane blocks, which are     determined by drug availability, regional and individual preferences, resource limitations     and financial considerations. The use of opioids is associated with adverse effects such as     nausea, pruritus, sedation, and occasionally respiratory depression.      Pregabalin is an anticonvulsant drug structurally related to the inhibitory neurotransmitter     gamma amino butyric acid, that exerts its action by binding to the α-2-δ subunit of the     voltage-dependent calcium channel. It reduces the release of the excitatory neurotransmitters     and inhibits the hyperalgesia and central sensitization.      A recent meta-analysis demonstrated that pregabalin reduce the postoperative 24 hours     cumulative opioid consumption and opioid-related adverse effects namely, vomiting and visual     disturbances after surgery. Compared with the use of pregabalin doses lower than 300 mg, the     use of doses higher than 300 mg even reduced opioid consumption by 35%.      It is not known if pregabalin is excreted in human milk. There is a case report on the     extensive excretion of pregabalin in breast milk, but with low measured concentrations in     infant as a consequence of maternal exposure during breast feeding. Food and Drug     Administration recommends to discontinue nursing or to discontinue pregabalin in nursing     mothers. Pre-delivery single exposure to pregabalin is expected to be safe for the newborns.      Up to the authors' best knowledge, this is the first clinical study on the efficacy and     safety of the administration of pregabalin before cesarean delivery.      We hypothesis that the preoperative administration of a single dose of pregabalin will     improve the quality of postoperative analgesia after cesarean delivery.      This placebo-controlled study aims to compare the effects of preoperative administrations of     single oral doses of pregabalin 150 mg and 300 mg on the postoperative pain scores,     cumulative patient controlled morphine consumptions, neonatal Apgar and neurologic and     adaptive capacity scores (NACS), and maternal and neonatal adverse effects in parturients     scheduled to elective Cesarean delivery under spinal anesthesia.   "
119657|NCT01719692|"     A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows     low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this     study is to compare the efficacy and tolerability of two different regimens of low doses     rituximab for the treatment of adult patients with ITP.   "
119658|NCT01719679|"     The provision of adolescent vaccination in a school setting will be feasible and acceptable     to parents as evidenced by the number and percentage of students immunized within each school     compared to those in schools without a program. The likelihood of vaccination for diphtheria,     tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate     vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a     comprehensive school-based immunization program will be significantly higher than that of     students enrolled in schools without a school-based immunization program.   "
119659|NCT01719666|"     The investigators hypothesis is lateral retinaculum release has no effect on treatment of     Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.   "
119667|NCT01719562|"     This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage     in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help     doctors predict whether patients will have heart damage caused by chemotherapy in patients     with cancer receiving chemotherapy.   "
119668|NCT01719549|"     This is a single-center, prospective, single-arm, open-label phase II study   "
119669|NCT01719536|"     The purpose of this study is to compare icotinib with induction and maintenance chemotherapy     in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR     mutation.   "
119670|NCT01719523|"     The purpose of this study is to examine the effects of EPI-743 on tic severity in adults with     Tourette syndrome.   "
119671|NCT01719510|"     The main objective of this study : Demonstrate that GBS (group B streptococci) ST-17     colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS     non-ST-17.      Secondary objectives:Determine:        -  The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant          women.        -  The frequency of colonization of neonates by GBS ST-17 at birth.        -  The preferential site of colonization in the mother (rectum, vagina, breast milk).        -  The kinetics of colonization after birth in the newborn.        -  The sensitivity and specificity of different GBS detection methods (conventional          phenotypic versus molecular) in the different types of samples from the mother and the          newborn.   "
119672|NCT01719497|"     The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging     agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and     binding characteristics.   "
119673|NCT01719484|"     To examine the influence of obesity on brain activation during food cue, stress, and neutral     relaxing conditions   "
119674|NCT01719471|"     To examine the influence of current daily tobacco smoking on brain activation during stress,     tobacco cue, and neutral relaxing conditions   "
119679|NCT01719406|"     Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a     condition that can adversely affect the pregnant woman, her developing fetus and future     events for both. To reduce GDM risk, we will develop and implement an in-person team and     web-based nutrition and exercise program for women, beginning in their first trimester. A     scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams     (5 women/team), will be developed and implemented among pregnant employees and/or their     spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate     daily physical activity with nutrition targets of five servings of fruits and vegetables, 3     servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will     occur before enrollment during the first trimester, each subsequent trimester and 12 weeks     after delivery. In addition to exercise and diet survey results, we will assess fasting     glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and     lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12     weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant     birth weight, and weekly health thermometer self-ratings during the assessment period.   "
119680|NCT01719393|"     Our hypothesis is that radial arterial pulse may reflect the severity and airway function in     asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery     in adult asthmatics, and evaluate its correlation with airy inflammation an lung funtion in     asthmatics.   "
119681|NCT01719380|"     This study will assess the safety and efficacy of LGX818 when combined with cetuximab or     combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer   "
119682|NCT01719367|"     Atrial fibrillation (AF), the most common sustained heart rhythm disorder, is becoming     increasingly prevalent in the Western world. The number of people with AF in the United     States is projected to roughly double by the year 2050, to an estimated 6-12 million. For     many patients with AF, rate control with atrioventricular (AV) node blockers is a widely     accepted therapeutic strategy. These agents control heart rate, thus preventing symptoms and     systolic heart failure associated with tachycardia due to a rapid ventricular response to AF.     Beta-blockers are widely accepted as first line agents for rate control in AF, especially     when patients have concomitant hypertension (HTN), coronary artery disease, cardiomyopathies,     or heart failure (HF). As a class, beta-blockers are among the most commonly prescribed     cardiovascular medications.      Among patients with AF treated with beta-blockers, the heart rate (HR) response varies     substantially. Sometimes, adequate rate control can be achieved by titration of the     beta-blocker dose; but frequently, additional AV nodal blockers and/or digoxin are necessary.     In some cases, adequate rate control cannot be achieved even with the simultaneous use of     multiple AV nodal blockers, necessitating mechanical ablation of the AV node and permanent     pacemaker implantation.      Patient-specific variables that influence the response to beta-blockers include comorbid     conditions, weight, age, and level of physical activity. Ethnic differences in the response     to beta-blockers for the treatment of HTN and HF are well-described. However, the     contribution of genetic variants to beta-blocker efficacy in AF is unknown. We propose to     study, using a candidate gene approach, the effect of genetic variants on heart rate response     to beta-blockade in patients with AF.   "
119683|NCT01719354|"     This is a trial to examine the effects of aftercare for mental health patients in community     health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric     hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two     groups: intervention group (community health center, primary care) or control group     (Community mental health centers of District Psychiatric Service, specialist care).      The project's primary objective is to investigate the effect of community services on     patients' functional capacity and user satisfaction after discharge. Secondly, the number of     treatment days and readmissions to mental health care will be examined. The project will also     compare costs of hospitalization, in psychiatric hospital and community health center     respectively. Data will be collected from community health records, medical records and     patient systems in psychiatric hospital, community mental health centers of District     Psychiatric Service (DPS) and questionnaires filled out by patients.   "
119942|NCT01715974|"     The purpose of this study is to determine whether in Assisted Reproductive Technologies the     treatment with G-CSF, a growth factor working on stem cells, may improve the pregnancy rate     and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.   "
119684|NCT01719341|"     Allogeneic haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy     for patients with both haematological and some non-haematological disorders. However, one of     the major limiting factors for transplantation is the inability to identify a suitable     HLA-matched donor. Development of an cost-effective and clinically efficacious alternative to     HLA-identical sibling or unrelated donor transplantation would significantly expand the     availability of allogeneic HSCT to patients in Singapore. Preliminary results indicate that     the use of high dose post-transplant cyclophosphamide (Cy) for graft versus host disease     (GVHD) prophylaxis in haplo-identical allogeneic HSCT is associated a low incidence of GVHD     and low treatment related toxicity. We propose a phase II clinical trial to assess the     efficacy of a haplo-identical allogeneic transplantation protocol using high dose     post-transplant Cy for the treatment of patients with haematological disorders. A     non-myeloablative protocol (Fludarabine-low dose cyclophosphamide-TBI) will be used for     patients with bone marrow failure syndromes and indolent lymphoid disease. In view of the     higher relapse risk of patients with myeloid malignancies, these patients will be treated     with a reduced intensity conditioning regimen (Fludarabine-Busulphan). The primary end-point     of the study will be overall survival at one year. Economic cost of the haplo-identical     transplantation, as well as treatment timelines will be recorded and compared will other     forms of unrelated donor allogeneic transplantation (umbilical cord blood transplantation and     unrelated HLA-matched adult donor). Immunological reconstitution of patients following     haplo-transplantation will be analysed and data will be utilized to guide future     immunotherapy strategies post-transplantation.      One year survival after non-myeloablative haploidentical stem cell transplantation is not     inferior to that observed after non-myeloablative volunteer unrelated donor or unrelated cord     blood haematopoietic stem cell transplantation.   "
119685|NCT01719328|"     The purpose of this study is to examine the immediate and cumulative effects of yoga on     stress and mood among young adult college students attending an 8-week program in Vinyasa     yoga.   "
119686|NCT01719315|"     The goal of this project is to examine the neurophysiology of hypersomnia during sleep and     wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders,     and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to     determine if this decreases daytime sleepiness in these patients. The primary study     hypotheses are that individuals with hypersomnolence will have reduced slow wave activity     (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain     regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent     patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve     subjective sleepiness.   "
119986|NCT01715415|"     The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and     ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as     dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected     treatment-experienced adults.   "
119687|NCT01719302|"     Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients     with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine     kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.      The Phase I component of this study is designed to determine the maximum tolerated dose of     pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to     determine the overall response rate of the combination of docetaxel, gemcitabine and     pazopanib prior to surgical resection in patients with soft tissue sarcoma.   "
119688|NCT01719289|"     Background: depression during pregnancy is an important problem for public health. It has     direct consequences for the affected woman, her children and family, and is a strong     predictor of post-partum depression. In developing countries depression during pregnancy is     highly common, and usually unrecognized and untreated.      Aim: to evaluate the effectiveness and cost-effectiveness of an intervention delivered by     nurse assistants in the management of pregnant women with depression in primary care clinics     that adopt the Family Health Strategy in Sao Paulo, Brazil.      Method: PROGRAVIDA is a cluster randomized controlled trial with pregnant women with     depression attending pre-natal care in 12 Primary Care Units with Family Health Program,     covering an area of 400,000 inhabitants in Sao Paulo, Brazil. The intervention follows a     stepped-care approach and is delivered by health professionals working at the primary care     unit responsible by the care of the women. All women from the intervention group receive a     program based on psycho-education and problem solving techniques, delivered by a nurse     assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2     after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the     beginning of the sessions. Women with severe depression are referred to the family doctor and     are assessed for the need of antidepressant medication. The control group receives routine     care. The primary outcome is remission of depressive symptoms 4-months after the inclusion in     the study. Secondary outcomes include remission of depressive symptoms at 6 months after     delivery. Women are also assessed for socioeconomic and household characteristics, social     support and obstetric complications. The effectiveness and cost-effectiveness of the     intervention will be assessed with intention-to-treat analysis, using the clinical outcome     and the assessment of quality of life (EQ-5D) four months after inclusion in the trial.   "
119689|NCT01719276|"     The purpose of this study is to compare the efficacy of graded activity program and     supervised exercise on pain, functional disability, quality of life, global perceived effect,     return to work, physical activity, physical capacity and strength of the lower limbs in     patients with chronic non-specific low back pain   "
119690|NCT01719263|"     This study is designed to demonstrate safety and efficacy in patients with severe upper lobe     predominant emphysema. For validity of the study, the results will be compared to patients     that receive optimal medical therapy.   "
119691|NCT01719250|"     This pilot clinical trial studies how well buparlisib works in treating patients with     non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to     previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth.   "
119692|NCT01719237|"     A double blinded randomized controlled trial comparing the onset and duration of the Onset     and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local     anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic     (Ropivacaine-Chloroprocaine Mixture).   "
119693|NCT01719224|"     The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases     the likelihood of upper airway vulnerability to collapse. Furthermore, the investigators want     to elucidate the anatomical and physiological risk factors that contribute in the upper     airway obstruction in post-partum patients.   "
119694|NCT01719211|"     The investigators have successfully identified two novel genetic loci for MVP on chromosomes     11 and 13 and are searching for altered genes in these regions. This requires recruiting     large families who may have MVP linked to these or other chromosomes; and obtaining DNA     samples from 1,000-1,500 individually affected patients to study the relation between DNA     markers throughout the genome and MVP. It is our expectation that the results of this study     will lead to the discovery of gene(s) responsible for MVP. This will lead to improved     understanding of the disease and, in turn, improved ability to treat and prevent progression     in genetically susceptible individuals.   "
119695|NCT01719198|"     The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the     assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin     level, which could mean the role of fecal calprotectin as a screening marker for colon     adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for     screening in this study.   "
119699|NCT01719146|"     The purpose of this study is to prospectively collect data on doses of Erythropoietic     Stimulating Agents and Intravenous Iron, and the markers of erythropoietic activity and iron     status. These data will be used to derive mathematical models which will subsequently guide     dosing of both agents, such that a desired therapeutic outcome is achieved in every patient,     while minimizing patient exposure to both agents.   "
119700|NCT01719133|"     Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the     major birch allergen bet v 1, in subjects allergic to birch pollen.   "
119701|NCT01719120|"     The aim of this study is to develop an Internet-based self-help therapy program for insomnia     in Chinese language, and to conduct a randomized waiting-list controlled trial on the     efficacy of Internet-based self-help therapy for insomnia.   "
119702|NCT01719107|"     The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency     and severity in children of 5-16 years old and with diagnosis of FAP.   "
119715|NCT01718938|"     This is a multicenter, randomized, double-blind, incomplete block, three period fixed     sequence crossover, multicenter, placebo-controlled study. The study will assess three oral     doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three     periods of 1-week duration each, with a 1-week washout period between treatment periods, in     subjects with diabetic or idiopathic gastroparesis.      Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic     gastroparesis by assessing changes in gastric emptying.   "
119703|NCT01719094|"     Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer,     occurring at a significantly younger age than in the general population. The increased     incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and     mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover,     understanding of the mechanisms by which cancer treatment could influence the occurrence of     latent cardiovascular events is unavailable. Our group and others have established     independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in     middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes,     cardiac death, and congestive heart failure. The goal of this application is to show that     childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health     have increased aortic stiffness, when compared to healthy adolescent and young adult age     mate. Studies are designed to determine if MRI measures of cardiovascular function differ     between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and     adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The     investigators propose that MRI markers responsible for cardiovascular events represent new     clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.   "
119704|NCT01719081|"     This project involves the assessment of the efficacy of two different image guided techniques     in patients with low back pain due to arthritis of the sacroiliac joint (SIJ).     Intra-articular injection of local anesthetics and steroids is performed to relieve pain     originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this     procedure but there is a growing interest in use of ultrasound (US) for this procedure. US     avoids radiation exposure to the patient and the health care team (HCT) and is less     expensive. We aim to compare procedural efficacy related outcomes for SIJ injections     performed using these image-guided modalities.   "
119705|NCT01719068|"     This is a pilot study that aims to develop a lung cancer screening program for workers in     British Columbia, Canada exposed to asbestos who are at risk of developing lung     cancer/pleural mesothelioma. This is high risk population is at of respiratory system     diseases as a result of their occupational exposures. Additionally, knowledge garnered from     this study will allow us to develop other studies that will further our understanding of     asbestos related lung cancer and mesothelioma.   "
119706|NCT01719055|"     To compile characteristics of real-world clinical outcomes for Boston Scientific commercially     approved neurostimulation systems for pain in routine clinical practice, when used according     to the applicable Directions for Use      - and -      To evaluate the economic value and technical performance of Boston Scientific commercially     approved neurostimulation systems for pain in routine clinical practice   "
119707|NCT01719042|"     The purpose of this study is to improve tolerance of treatment of pulmonary Mycobacterium     avium Complex disease via the use of therapeutic drug monitoring and the addition of     anti-nausea medication or dietary supplements to the patients' daily drug regimen. The aims     of this study are to use (1) Zofran® (Ondansetron 8mg), an anti-nausea medication or (2) a     dietary supplement to decrease medication related gastrointestinal side effects of     medications used to treat Mycobacterium avium Complex.   "
119708|NCT01719029|"     A better understanding of the optimal diet for women with gestational diabetes is fundamental     to the management of this rapidly growing problem in pregnancy. Careful comparison studies of     the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate     but lower in fat is critical in order to determine which diet results in a more favorable     maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect     optimal fetal growth and may influence the future health of the offspring.   "
119709|NCT01719016|"     Diagnosis of relative contributions of large artery blockages and microvascular blockages is     very much needed in the treatment of coronary artery disease. In order to achieve this, two     novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings     and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with     pressure and flow readings, are being investigated.   "
119710|NCT01719003|"     This study will investigate the efficacy and safety of two doses (high and low) of     empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in     patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of     empagliflozin + metformin versus each individual component after 24 weeks of treatment.   "
119734|NCT01718691|"     The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day     consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip     infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma     where hematopoietic stem cell transplantation is not indicated.   "
119735|NCT01718678|"     The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment     of fatigue and Quality of Life of MS patients.   "
119711|NCT01718990|"     Drug discovery can take many years especially since most studies to measure effectiveness     depend on clinical outcomes like pulmonary function tests and hospitalizations.      This is an observational study designed to collect information, blood, and bronchoalveolar     lavage fluid in people who have IPF and those who do not. The people who have IPF will be     followed for 12 months to collect more biological samples and record clinically relevant     information.      The goal of this study is to identify new molecular markers that are measurable and reliable     in people who have IPF. It is hoped that these markers can be used in future drug studies to     significantly speed up the process of finding drugs that help.   "
119712|NCT01718977|"     This study aims to determine whether body weight-supported treadmill training (BWSTT) has     beneficial effects, over and above arm-cycle ergometry training (ACET) on indicators of     cardiovascular disease (CVD) risk in individuals with severe spinal cord injury (SCI).      After SCI, the primary cause of illness and death is CVD. Currently, preventative measures     focus around increasing physical activity- especially through the use of ACET. However,     ACET's capacity to improve cardiovascular health is questionable. Research has demonstrated     that BWSTT, an alternative form of exercise, may be capable of improving cardiovascular     health in individuals with SCI.      The studies primary outcome measure is aortic pulse wave velocity (aPWV) which has been shown     to have prognostic value for CVD above and beyond that of other risk factors. It is     hypothesised that through large muscle mass involvement and postural challenge, the physical     stimuli of BWSTT will reduce aPWV and lower CVD risk in individuals with SCI.   "
119713|NCT01718964|"     To investigate the effects of cortisol on heroin craving and stress reaction in heroin     addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single     administration of study medication Study hypothesis:Cortisol has an inhibiting effect on     heroin craving and stress reactivity in opioid dependent subjects.   "
119714|NCT01718951|"     To compare the efficacy of golimumab with pamidronate in the treatment of axial     spondyloarthropathy   "
119716|NCT01718925|"     The burden of chronic disease is continuing to rise. Even though patients may be in remission     or have quiescent disease, several studies have confirmed that symptoms, such as e.g.,     fatigue, is troublesome.      The primary aim of this study is to investigate whether or not there might be an association     between levels of vitamin D and the subjective experience of fatigue in conditions, such as     inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel     syndrome.      Secondary aims is to study both the co-occurence and influence of pain, depression and     anxiety.   "
119717|NCT01718912|"     Many physically handicapped patients at the dental department, Toronto Rehabilitation     Institute(TRI) have considerable gingival inflammation and breath odour because of the     inability to effectively handle a toothbrush. These patients have considerable periodontal     disease. There is a concern that these pathogens may have a detrimental effect on wound     healing in other areas of the body.      Hypothesis: Patients attending the dental department at TRI that are treated with the     antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial     decrease in periodontal disease as measured by bleeding points and pocket depth when compared     to the group that continues to use their regular oral hygiene methods (control group).   "
119718|NCT01718899|"     The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer     vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent     and in combination with lenalidomide.   "
119719|NCT01718886|"     The objective of this study is to evaluate the initial safety and preliminary effectiveness     of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27     - 35 kg/m^2   "
119720|NCT01718873|"     The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared     to giving bevacizumab at the same time as chemotherapy improves patient overall response to     treatment.   "
119721|NCT01718860|"     This is a secondary analysis of a previously performed prospective, observer-blinded,     observational study at Massachusetts General Hospital. The primary aim of this study is to     evaluate the effects of residual paralysis at admission to the post-anesthesia care unit     (PACU) on total costs of hospital care.      Secondary analyses will be conducted to evaluate the effects of postoperative residual     paralysis on potential cost-influencing factors, i.e. incidence of minor and major     postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive     care unit (ICU) admission rate, as well as length of stay in the PACU.   "
119722|NCT01718847|"     The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the     efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line     monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR     tyrosine kinase inhibitors (TKIs).   "
119723|NCT01718834|"     Description: A randomized Placebo-controlled study to evaluate safety and efficacy of Cenv3     peptide vaccine in normal volunteers. This study is designed to test safety of 3 consecutive     monthly escalating doses of the immunogen ( 0.324 mg, 0.648 and 3.240 mg / 70 kgm body     weight) in 40 healthy male subjects (15,15 and10 subjects respectively) plus 10 subjects on     placebo. Bioavailability of Cenv3 will be tested throughout the duration of the experiment.     In the study hyperimmune state will be achieved via 3 subcutaneous injections (0.648 mg     each), once every 4 weeks. A placebo treated healthy subjects ( n= 10) will serve as     controls. Chronic HCV patients ( n=50) who did not respond to IFN + RBV combined therapy will     be recruited to test therapeutic efficacy of the compound via 6 consecutive injections (     0.648 mg each ) every 2 weeks. ( NB : this group of patients has been already recruited in     the first part of this project where evaluation of the compound is currently underway).     Immunized healthy volunteers will be followed for a year compared with placebo group, where     all biochemical, hematological, immunological and allergic parameters are recorded. Treated     CHC patients will be evaluated for virological, hematological, biochemical and immunological     states at the end of treatment.      Subject : Cenv3 potential prophylactic and therapeutic immunogens in healthy volunteers and     against chronic HCV infection respectively.   "
119736|NCT01718652|"     The purpose of this study is to determine how a single dose of cyclosporin affects the     pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin     (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy     volunteers.   "
119724|NCT01718821|"     Pain is one of the most common symptoms associated with cancer. The approach to pain     management compresses routine pain assessments, utilizes both pharmacologic and     nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain     can be well controlled in the vast majority of patients if the algorithms of pain control are     systematically applied, carefully monitored, and tailored to the needs of the individual     patient.This study is aimed to assess the current pain managements in upper gastrointestinal     cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled     patients would also be assessed.   "
119725|NCT01718808|"     OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront     cetuximab treatment delivered as monotherapy or as part of a combination treatment with     capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral     oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic     colorectal cancer (mCRC).   "
119726|NCT01718795|"     During CPR bag-valve mask ventilation is difficult for basically skilled rescuers.     Ventilation may be inefficient or with too high pressures result in stomach inflation and     aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal     tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital     study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR.     Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask     performed by paramedics during CPR.   "
119727|NCT01718782|"     The purpose of this study is determine safety and efficiency of mechanical ventilation in     children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA     Supreme). The main interest is leakage pressure of oropharynx and stomach. The null     hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The     alternative hypothesis is that there is a difference in leakage pressure.   "
119780|NCT01718080|"     Our goal is to investigate how hormones that control blood sugar, hunger, and stomach     emptying change with puberty and being overweight. These substances change with a meal.        -  For this, we need to compare lean and overweight children.        -  We need to study them before and during puberty.        -  All children in the study will be tested before and after a liquid meal.   "
119728|NCT01718769|"     Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to     weight loss or insufficient weight gain, is related to an increase in morbidity and mortality     and exposes the child to medical complications. In addition, obesity is also related to     complications during hospitalization and complications in general, and therefore early     identification of these children is extremely important. Studies show that malnutrition is     frequent among children upon hospitalization, where the risk of pediatric nutritional     deterioration increases, even in the presence of mild stress factors. This risk is frequent     mainly among children that arrive at the hospital with an initial poor nutritional status.     Improving the nutritional status as part of the standard of care already at the ambulatory     setting might improve the prognosis of children when ill. In Israel, nutritional screening in     not conducted among children since there is no proper validated screening tool. Study     objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk     which is designed to be used by nurses, and to compare it to a complete nutritional     assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the     investigators wish to examine the effects of using a screening tool for nutritional risk on     the medical staff's attention to the nutritional status; this is measured by the collection     of nutritional status-related data and their recording in the patient file.      Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric     Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3     questions with a summary score, according to which the nutritional risk level shall be     determined. These children shall also undergo a complete dietician assessment in order to     examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the     beginning of the research and after 6 months in order to estimate the change in medical     staff's attention to nutritional status, by way of noting relevant diagnoses, reference to     nutritional status- related tests and recording of anthropometric measurements.      A statistical analysis to examine the validity of the STAMP Tool shall be carried out using     the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi     square test.   "
119729|NCT01718756|"     Perioperative continuous infusion of lornoxicam would be an effective and safe regimen to     reduce the patient controlled morphine consumption after orthopaedic surgery.      After ethical approval, 96 patients scheduled for elective orthopaedic fracture surgery under     general anaesthesia were randomly allocated to receive placebo, 12-hourly iv lornoxicam 16 mg     or lornoxicam 16 mg followed with continuous infusion of 1.3 mg/hr., for 48 hours after     surgery (n=32 per group). Anaesthesia was induced with propofol, sufentanil and rocuronium,     and was maintained with 0.5-1 minimum alveolar concentration sevoflurane, sufentanil and     rocuronium. Postoperative patient controlled morphine analgesia was used. Changes in heart     rate, mean blood pressure and sevoflurane minimum alveolar concentration, visual analogue     pain scores, and cumulative patient controlled morphine consumptions and blood loss for 48     hours, platelet functions, bone non-union and the presence of adverse effects were recorded.   "
119730|NCT01718743|"     The goal of this clinical research study is to learn if the combination of MLN9708 and     Revlimid (also called lenalidomide or CC-5013) can help to control MM as maintenance     treatment after an autologous stem cell transplant.      Lenalidomide is designed to change the body's immune system. It may also interfere with the     development of tiny blood vessels that help support tumor growth. This may decrease or     prevent the growth of cancer cells.      MLN9708 is designed to block a protein that plays a role in cell function and growth. This     may cause cancer cells to die.   "
119731|NCT01718730|"     The purpose of this study is to learn if measures of brain activity are different in children     and adolescents with depression who are in different stages of treatment. This is important     because it may identify a biological marker for depression that could one day be used to     identify depressed children who would benefit from certain treatments (medications for     example), or to monitor how well treatments are working. Brain activity measures(known as     cortical excitability and inhibition) will be collected by Transcranial Magnetic Stimulation     (TMS). TMS is a noninvasive (no surgery or implants) brain stimulation technology which can     make parts of the brain work without putting any wires or chemicals into the body.     Measurements will take place over one 3-hour visit. This study does not provide any form of     treatment.      *There is an optional portion of the study that uses a brain scan to gather measures of brain     structure and brain chemicals. The brain scan is called magnetic resonance and spectroscopy     (MRI/MRS). MRI/MRS uses magnetic fields to study the structure of the brain and brain     chemicals. The PI will determine eligibility for the MRI/MRS portion of the study.   "
119732|NCT01718717|"     Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce     the occurrence of AF if it is continued for six postoperative days instead of just three.   "
119733|NCT01718704|"     The purpose of this study is to evaluate whether using penile vibratory stimulation with the     Viberect handheld device can help the recovery of erections and urinary control after radical     prostatectomy.   "
119737|NCT01718639|"     This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical     trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in     postprandial heartburn.      The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in     terms of efficacy for postprandial heartburn treatment.   "
119738|NCT01718626|"     Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to     concomitant S1+Docetaxel in the safety and clinical efficiency.      Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance     treatment for advanced gastric cancer.   "
119739|NCT01718613|"     Although arginine vasopressin has been used as an additional drug in refractory shock in     worldwide clinical practice, there are no prospective studies using it as a first choice     therapy in patients with cancer and septic shock.      The aim of this study is assess if the use of arginine vasopressin would be more effective on     treatment of septic shock in cancer patients than norepinephrine, decreasing the composite     end point of mortality and organ failure in 28 days.   "
119797|NCT01717859|"     The purpose of this research study is to determine if a change in inflammation or baseline     inflammation seen on the ultrasound is a good indicator of how rheumatoid arthritis patients     respond to TCZ 4mg/kg and whether early prediction of dose escalation is possible by     utilizing ultrasound inflammatory measures.   "
119740|NCT01718600|"     Microembolization is commonly associated with carotid artery stenting (CAS), but our     understanding of subclinical microembolization is superficial. Through collaborative effects     of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to     better understand the clinical significance and long-term cognitive effects of microemboli.     This proposal may change our current clinical practice by providing a better outcome measure     for carotid interventions and improving outcomes of CAS procedures through risk factor     stratification. Our central hypothesis is that development of subclinical microemboli is     associated with decline in cognitive function following CAS and that the risk of development     of microemboli themselves is associated with patient- and procedure-related factors. We hope     that this prospective study will help to clarify these important issues in the era of rapidly     evolving percutaneous interventions.   "
119741|NCT01718587|"     The current treatment methods of liver cirrhosis are limited ,including antiviral     therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive     therapy especially the regularly intravenous infusions of plasma or albumin are combined in     the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem     cell with self and directed differentiation capacity can effectively rescue experimental     liver failure and contribute to liver regeneration, which suggests the feasibility of stem     cell transplantation therapy. In this study, the safety and efficacy of umbilical cord     mesenchyma stem cell transplantation through interventional procedures and classical therapy     in patients liver cirrhosis will be evaluated and compared.   "
119742|NCT01718574|"     The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a     sense of empowerment, coping, quality of life and reducing distress for patients with cancer.   "
119743|NCT01718561|"     In general anesthetic the patient is deprived of his awareness and ability to breathe. It is     therefore one of the most important tasks in anesthesia to ensure the patient's airway and     breathing. It has been shown both in Denmark and internationally that failed management of     the patient's airway is the main anesthesia-related cause of death and brain damage.     Therefore, it is very important and highly prioritized among anesthesia personal, to be able     to identify patients with a difficult airway. The aim of The DIFFICAIR Trial is to reduce     the incidence of UNEXPECTED difficult airway management by optimizing assessment of the     patient's airway before anesthesia. There is an international consensus on the importance of     proper identification of patients with a difficult airway prior to anesthesia. Enabling     optimal preparation and thus reducing mortality and complications. The DIFFICAIR Trial is a     nationwide multicentre trial with approx. 70,000 patients. 28 of the country's anesthesia     departments is randomized either to airway assessment based on the physicians' clinical     judgment (current practice) or to use an objective risk score for airway evaluations     including anatomical conditions known to be associated with difficult airway management. Data     from The Danish Anesthesia Database is used to compare the success rates of the two methods.     We hope that by using a systematic airway assessment we may reduce the number of unexpected     difficult airway managements and thereby reducing the associated complications and death.     Based on data we will contribute to a national recommendation for airway assessment before     anesthesia.   "
119744|NCT01718548|"     Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many     years for treatment of a variety of conditions. The aim of this study is to evaluate the     effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on     cardiopulmonary fitness and cognitive functioning in young, healthy physical education     students.   "
119745|NCT01718535|"     The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a     qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and     *17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed to     demonstrate the concordance (positive and negative percent agreement) by comparing the     Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the     concordance between three different sample transport embodiments provided to laboratories for     use in transporting the reagent tubes with collected buccal sample swab to the laboratory.   "
119746|NCT01718522|"     The purpose of this registry is to collect the real life data on Sensor Augmented pump     therapy usage in type 1 DM patients treated with Medtronic Insulin pumps and countinuous     glucose monitoring systems in Germany.   "
119747|NCT01718509|"     The primary objective of the study is to demonstrate the efficacy of SPD489 compared with     placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating     Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as     days during which at least 1 binge episode occurs) per week as assessed by clinical interview     based on subject diary   "
119748|NCT01718496|"     The investigators are studying the effect of a single dose Opioid drug (Morphine) on dyspnea     and exercise tolerance in COPD patients.   "
119749|NCT01718483|"     The primary objective of the study is to demonstrate the efficacy of SPD489 compared with     placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating     Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as     days during which at least 1 binge episode occurs) per week as assessed by clinical interview     based on subject diary   "
119750|NCT01718470|"     Extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes     that can cause cerebral edema and hemorrhage. The hemodynamic profile on emergence is more     favorable if a laryngeal mask airway (LMA) is inserted before neurosurgical patients emerge     from anesthesia. We aimed to compare the impact of awakening neurosurgery patients after     insertion of a ProSeal LMA to replace the endotracheal tube (ETT).   "
119761|NCT01718327|"     For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered     as the reference treatment in first line chemotherapy. However, the outcomes of these     patients remain limited and therefore more effective drugs are warranted. The context of the     disease and current data on sunitinib suggest that sunitinib may have activity in patients     with advanced non resectable cholangiocarcinoma.      Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity     of sunitinib in such a patient population.   "
119798|NCT01717846|"     This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related     genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.   "
119751|NCT01718457|"     Diabesity (Diabetes accompanied by obesity) is a prevalent condition many times complicated     by micro- and macrovascular disease. Many treatments for Diabesity paradoxically cause     further weight gain and hypoglycemia. The Endobarrier enables diabetes control along with     weight loss as an alternative to bariatric surgery for patients who are not interested or not     qualified for surgery. The aim of this study is to assess the efficacy and safety of the     Endobarrier Diabesity patients in Israel.      This study will include 45 men and women between the ages of 18-65 with HbA1c level of 8% and     above and a BMI of 30 kg/m2 or above.      Exclusion criteria: use of anti-coagulant, use of steroids or inability to discontinue these     medications.      The cohort will be followed for two years during which the patients will be monitored for     diabetes control (by using a continuous glucose monitor), weight, blood pressure, lipid     profile, fatty liver (by Ultrasound and blood markers for inflammation and fibrosis) and     change in plasma gut peptide levels. The Endobarrier will be explanted after one year,     however the monitoring of the patients will continue for another year.   "
119752|NCT01718444|"     Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility     treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some     preliminary data suggest that skipping PIES could result in a higher live birth rate. The     investigators are performing the first randomized controlled trial to find out if skipping     the use of progestin during fertility treatment of anovulatory PCOS women is associated with     improved pregnancy and live birth rates compared to the traditional approach of using     progestin prior to use of clomiphene citrate.   "
119753|NCT01718431|"     This study aims at investigating the impact of colonic fermentation of intrinsic indigestible     carbohydrates in cereal whole kernels after three days consumption, on metabolic variables     and cognition. The study is performed in healthy, normal to slightly over-weight test     subjects.   "
119754|NCT01718418|"     The purpose of the study is to evaluate food factors related to colonically derived     regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal     study in healthy subjects as experimental model.   "
119755|NCT01718405|"     Studies have shown that an acute bout of aerobic exercise positively effects cognition,     mainly executive functioning; however the effect is not observed among all people and it is     not clear whether only aerobic exercise can produce this effect or possibly also resistant     exercise. The main purpose of our study is to examine whether genetic variation is a     moderator of this effect and whether resistant exercise is comparable to aerobic exercise in     improving cognition following a single bout of exercise.   "
119756|NCT01718392|"     the purpose of this study is to investigate the development of insulin resistance in multiple     sclerosis patients + explaining the effects of a combined training programme on insulin     resistance, muscle power and aerobic capacity in multiple sclerosis patients   "
119757|NCT01718379|"     The goal of the present study is to assess, through a randomized phase II trial, the efficacy     and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent,     ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5     abnormality.      Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4     months. Responders will be eligible for maintenance treatment with cycles identical to the     first cycles, until relapse occurs or until unacceptable toxicity.   "
119758|NCT01718366|"     Determinate safety and response rate of the association Deferasirox -Vitamine D - Azacitidine     in treatment of high risk MDS      Deferasirox Exjade:      The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is     scheduled during the phase I, with 5 additional patients per group.      The maximal tolerated dose of Deferasirox will be required for the phase II of the study.      The first dose will be assigned according to the ferritin level of the patient at time of     inclusion:      5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin     is ≥1000ng/ml) in Group 2      Group 1 : Ferritin 300 to 1000ng /ml:        -  cohort 1 : 5 mg/kg/d        -  cohort 2 : 10mg/kg/d        -  cohort 3 : 15 mg/kg/d      Group 2 : Ferritin > 1000ng /ml:        -  cohort 1 : 10 mg/kg/d        -  cohort 2 : 15mg/kg/d        -  cohort 3 : 20 mg/kg/d           5 patients will be treated by cohort. In absence of toxicity (extra-hematological          toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included          in the next cohort.      Deferasirox will be administrated once daily during all the study period. Uvedose will be     administrated once weekly during all the study period (100.000 UI P.O).      Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each     cycles(One cycle is 28 days)      During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine      Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity     or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to     evaluate the efficacy of the treatment.      No dose modification of deferasirox will be done after 3 cycles of treatment except in case     of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with     the same dose of Deferasirox until progression .   "
119776|NCT01718132|"     Aim of this prospective study was to assess the quality of postoperative care in a     postoperative anaesthesia care unit (PACU) using postoperative pain, nausea and vomiting as     well as their reduction as quality markers. So far, only sparse data related to this topic     are available and there are currently no established quality markers of a PACU service.   "
119777|NCT01718119|"     The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel     for inducting final follicular maturation and early luteinization in women undergoing     ovulation induction for assisted reproduction treatment   "
119759|NCT01718353|"     Primary Objectives:        -  To explore the benefit of an early switch from docetaxel/prednisone to cabazitaxel/          prednisone in men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who do          not achieve ≥30% prostate-specific antigen (PSA) decline from baseline by cycle 4 with          the initial docetaxel treatment.        -  To evaluate the circulating tumor cells (CTCs) with clinical response/resistance to          docetaxel or cabazitaxel treatment.      Secondary Objectives:        -  To assess efficacy and safety of the two treatment strategies, switch from          cabazitaxel/prednisone to docetaxel/prednisone and docetaxel/prednisone to          cabazitaxel/prednisone.        -  To evaluate efficacy in patients receiving initial taxane treatment before the switch          and efficacy under the alternate taxane after the switch within each initial treatment          group.      To explore:        -  Ribonucleic acid (RNA) sequencing on CTCs to assess for tubulin mutations and androgen          receptors (AR) isoforms.        -  Deoxyribonucleic acid (DNA) sequencing on CTCs to validate RNA sequencing results.        -  To measure PSA response (≥30% and ≥50% reduction in PSA from baseline) in patients who          have been previously treated with a high potency AR-targeted agent (AR signaling          inhibitor or CYP 17 inhibitor).   "
119760|NCT01718340|"     The prevalence of insulin resistance is increased in women with recurrent miscarriage     compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only     implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical     complications during pregnancy.An elevated free androgen index appears to be a prognostic     factor for a subsequent miscarriage in women with recurrent miscarriage.      There is insufficient evidence to evaluate the effect of metformin supplementation in     pregnancy to prevent a miscarriage in women with recurrent miscarriage.   "
119762|NCT01718314|"     Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables     the doctor to do minor operative procedures. Although it causes little discomfort, sometimes     it may be disturbing for the patient. This pain is usually perceived during the passage of     the instrument through the cervix (neck of the womb). The investigators would like to     minimize this pain by two drugs: Misoprotol and lidocaine   "
119766|NCT01718262|"     The purpose of the study is to measure the blood levels of the medicine called ropivacaine     (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not     the subject of this study, but the investigators are studying how much of the drug can be     found in the patient's blood, known as the blood level, of this medicine. Too much     ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve     catheter is removed, local anesthetic toxicity is no longer a potential problem. However,     there is little data on what ropivacaine blood levels are after having the catheter in for a     long period of time(up to one month).   "
119767|NCT01718249|"     Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest     that deep brain stimulation of the thalamic-tegmental reticular system could improve     consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this     protocol is to study the effects of deep brain stimulation on conscious behavior, using a     patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised     (CRS-R) as clinical assessment criterion.   "
119768|NCT01718236|"     The project aims to introduce into clinical practice for Caesarean section conducted under     general anesthesia with the rapid induction myorelaxation with rocuronium and the reversal of     neuromuscular blockade by using sugammadex. The aim is to demonstrate at least the same     efficiency and confirm the safety of the procedure for both mother and newborn compared with     older procedure.   "
119769|NCT01718223|"     This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in     treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy     uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active     when it is exposed to light. When the drug is active, tumor cells are killed. Giving     photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce     the amount of normal tissue that needs to be removed.   "
119770|NCT01718210|"     The purpose of this study is to determine whether in Assisted Reproductive Technologies the     use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may     improve the embryo implantation in patients experiencing recurrent implantation failure in     IVF cycles.   "
119771|NCT01718197|"     The mission of SARP is to improve the understanding of severe asthma through integrated study     of its clinical and biological features and to evaluate their changes over time. The ultimate     goal of these efforts is to promote better treatments for severe asthma.   "
119772|NCT01718184|"     A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric     intraocular lens in pseudophakic patients for correcting refractive errors following corneal     transplantation   "
119773|NCT01718171|"     Although the presence of SIRS has been described in patients with appendicitis, its     progressive response related and together with progression of symptomatology from the onset     of symptoms to diagnostic has not been characterized. Continuation of the systemic     inflammation in patients with injury and infectious processes may result in multiple organ     dysfunction and ultimately failure. As with any acute inflammatory condition, the patients'     systemic inflammatory response to appendicitis will progress and become more intense with the     passing of time. The purpose of this study is to characterize the systemic inflammatory     response to appendicitis from the beginning of symptoms to diagnostic in patients with     appendicitis submitted to emergency surgery.   "
119774|NCT01718158|"     The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a,     given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as     the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects     who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior     anti-HCV treatment, or who have relapsed after an initial, successful treatment with     Pegylated Interferon Alfa + Ribavirin   "
119775|NCT01718145|"     The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032     combination therapy in Japanese subject.      The purpose of this study is to compare the anti-viral activity of the co-administration of     Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese     Hepatitis C virus (HCV) subjects   "
119778|NCT01718106|"     Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long     coronary stenoses but this strategy is expensive and the response to overlapping DES has not     been extensively studied. The recent availability of bioabsorbable polymer DES could allow     treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in     the vessel wall, even in case of overlapping stents.      Thus we planned to evaluate which of the 2 strategies, namely using a single long     biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in     treating long coronary stenoses.      The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients     with stable angina and at leat 1 coronary stenosis >28mm and <40mm of length will be     randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will     be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril     Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by     2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study     will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month     overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis     and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by     6-month control coronary angiography and late lumen loss in the stented vessel will be     measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara,     Italy)   "
119779|NCT01718093|"     The purpose of this study is to see if the use of metformin and sitagliptin used in     conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.   "
119781|NCT01718067|"     Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist     patients with chronic retention of secretions. VAKÜM technology has been recently developed     with the aim to improve the respiratory condition in hypersecretive patients suffering from     chronic respiratory diseases.      The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with     hypersecretion, and chronic respiratory diseases a clinical trial has been designed.      Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die),     and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred to     standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind     multicentre randomized trial with consecutive recruitment. Following a preliminary run-in     period, group comparison will be made between Intervention group using VAKÜM system (Free     Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group     using manual ELTGOL alone over 10 daily sessions.      Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of     life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum     volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air     flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary     outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point     (SD 5) group difference change in the primary outcome at the end of the study period as     significant at the 0.05 level, at least 42 patients per group are needed. The minimum target     sample size will be then fixed at 50 patients per group.      An higher and faster significant reduction of the perceived dyspnea is supposed in the     Intervention group. Additional benefits among the secondary outcomes are also hypothesised in     the same group.   "
119782|NCT01718054|"     Sickle cell disease (SCD) is the most common inherited disorder worldwide affecting 300,000     births annually, most occuring in sub-Saharan Africa (SSA) where poor detection and care     result in high childhood mortality, malnutrition, illness and disability in survivors. SCD is     caused by abnormal haemoglobin, the compound in red blood cells(RBC) that carries oxygen.     Much of the disability in SCD may be caused by vascular damage from the breakdown of damaged     RBC. Research in high-income countries has led to some effective therapies but these are     currently costly and complex. The investigators will test two different formulations of an     affordable, ready-to-use supplementary food (RUSF) specifically tailored for children with     SCD. As well as containing energy, protein, essential fats, vitamins and minerals, the     vascular RUSF (RUSFv) will be fortified with the amino-acids arginine and citrulline and be     delivered with a daily chloroquine dose to create a novel nutraceutical intervention.     Arginine is converted to nitric oxide which is essential for vascular health. Arginine levels     are low in SCD because the arginine-degrading enzyme, arginase, is released from RBCs. The     investigators propose that by supplying additional arginine (and citrulline which converts to     arginine) and suppressing arginase activity (an action of chloroquine) the investigators can     improve vascular function. Our study will test this theory, and if provision of RUSF improves     growth in children with SCD.   "
119783|NCT01718041|"     This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients     with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a     single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6     months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary     endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.   "
119784|NCT01718028|"     The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day     for 30 days to increase non-invasive tear film break up time over baseline, compared to a     saline control, in dry eye subjects with lipid deficiency.   "
119785|NCT01718015|"     Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP)     remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism.     The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for     development and regeneration of the nervous system. In earlier studies reduced concentrations     of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle and skin     biopsies have been found in patients with DP.      Purpose: Our purpose is to determine the concentration and biological activity of     Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163     (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and     Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with     diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy     control subjects. We will furthermore relate the findings to peripheral nerve function. In     addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry.      Hypothesis: We hypothesize that DP develops due to reduced concentration and biological     activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and     BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients     without damage to the nervous system and healthy control subjects.      Methods: Study subjects consists of patients from Department of Neurology and Department of     Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital,     Denmark, who are having a lumbar puncture performed.   "
119786|NCT01718002|"     The care of the oral cavity is an important way to prevent local and systemic infections.     This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for     patients undergoing chemotherapy. The methodological design used was quasi-experimental     before-after intervention. The sample consisted of 23 subjects who performed the technique of     oral hygiene before and after watching an educational video. To do so was given a kit with a     toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product to     mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric test     t Student paired.   "
119787|NCT01717989|"     To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and     during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy     [End Stage Renal Disease (ESRD) Prospective Payment System (PPS)] to bundle reimbursement for     all dialysis services. Specifically, to describe CMS ESRD PPS quality performance measures     for dialysis centers over time.   "
119799|NCT01717833|"     The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for     muscle weakness following critical illness. The investigators hypothesized that NEMS combined     with exercise rehabilitation will have a beneficial role in restoration of muscle strength   "
119800|NCT01717820|"     The purpose of the study is to provide whole-grape powder or a placebo as a supplement to     postmenopausal women for 12 weeks to determine the effects on body composition and bone     formation.It is hypothesized that 12 weeks of supplementation with whole-grape powder will     decrease body fat via resveratrol's positive effects on metabolism and negative effects on     fat cells.   "
119788|NCT01717976|"     The Veterans' Health Administration (VHA) is committed to improving primary care through the     implementation of Patient Aligned Care Teams (PACTs). Improving access to services and care     coordination are among the primary goals of PACTs; however, there remain many unanswered     questions about how best to use the limited time of PACT team members, such as nurse care     managers, to accomplish this. This study will evaluate the effectiveness of a nurse-led     telephone support program for Veterans who have been treated recently in the emergency     department (ED) and are at high risk for repeat visits. The program's goals are to reduce the     need for future ED use and improve satisfaction among Veterans by providing information and     support related to the ED visit, enhancing chronic disease management and educating Veterans     and family members about PACT and other VA and community services. If proven effective, this     program could improve health and healthcare for a large, vulnerable group of Veterans and be     cost saving for VHA.   "
119789|NCT01717963|"     Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse,     overdose and overdose death. This risk is elevated even further following discharge from     treatment or correctional institutions where patients have been detoxified. At the moment,     state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake     of opioid medications like methadone or buprenorphine. Recently, a medication containing the     blocking agent naltrexone was approved in the US; this does not maintain dependence but     instead blocks heroin and other opioids for 28 days after intramuscular administration. This     study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension     (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge     from a treatment or correctional facility to participating catchment regions in Norway. The     main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the     proportion of biological samples negative for opioids, retention, self-reported use of     alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week     period where participants can receive the study medication of their choice. After the end of     the study, data from national registry databases can be collected for a further 12 months on     outcomes such as recidivism, mortality and morbidity.   "
119790|NCT01717950|"     Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic     cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has     protected animals from infection in challenge studies. This study will evaluate the safety     and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when     co-administered with different concentrations of the immunostimulant GLA-AF.   "
119791|NCT01717937|"     The purpose of this study is to determine whether phase variance optical coherence tomography     (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can     be used to generate angiographic images of the retinochoroidal vasculature that are     comparable to those produced by fluorescein angiography (FA), the current gold standard     diagnostic test.   "
119792|NCT01717924|"     The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled     trial comparing primary surgery versus primary chemotherapy followed by surgery in patients     with a resectable signet ring cell gastric adenocarcinoma   "
119793|NCT01717911|"     We have found that a 6-month course of insulin therapy after a short-term intensive insulin     therapy could shorten the period of hyperglycemia to preserve ß-cell function and further     improve long-term glycemic control in recently diagnosed type 2 diabetes with severe     hyperglycemia (>300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus     hypothesized that a 6-month course of basal insulin therapy could also help to preserve     ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300     mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin     therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the     diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with     better ß-cell function reservation. We skip a short-term intensive admission course of     insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe     hyperglycemia.   "
119794|NCT01717898|"     There will be two parts to this clinical research study. The purpose of each part is:        -  Phase 1: This part of the study will determine what dose of BEZ235 is safe to give with          a standard dose of abiraterone acetate and prednisone by administering different doses          of BEZ235. This will help to find out what effects, good and/or bad, this combination          has on CRPC.        -  Phase 2: This part of the study will measure the treatment effect of the combination of          BEZ235 and abiraterone acetate/prednisone on CRPC.   "
119943|NCT01715961|"     This clinical trial is a multicentric prospective study to assess the clinical and prognostic     value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.   "
119795|NCT01717885|"     The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa.     Malaria is one of the most important infectious diseases in the world. Uganda reports among     the highest transmission intensities in the world. Children and pregnant women are the most     vulnerable populations. HIV is also reported at high rates for these populations. If malaria     and HIV require treatment at the same time, there is a high risk for drug-drug interactions.     This study will:        1. Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r),          nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of          antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment          for uncomplicated malaria in HIV-infected children and pregnant women, and        2. Evaluate the impact of age and pregnancy on the PK exposure of AL.   "
119796|NCT01717872|"     To compare the laryngoscopy view using two standard clinical devices, the Macintosh and     Miller laryngoscopy blades, in infants between one day and two years of age.      Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in     pediatric clinical practice in some institutions especially in infants. The anatomy of infant     airway has traditionally been considered to lend itself to advantages of the Miller blade.     Some argue that the Miller blade offers a superior view of the laryngeal inlet because it     lifts the epiglottis. However, others use the Miller blade to expose the larynx without     lifting the epiglottis, supposedly to avoid traumatizing it. Despite the long-standing use of     these blades, more than 50 years, no systematic study has ever compared the laryngoscopy     views of the Miller and Macintosh blades in infants.   "
119987|NCT01715402|"     The aim of this study is to reduce the length of stay after liver surgery by taking account     of objective quantitative clinical variables, subjective qualitative clinical variables and     non clinical variables.   "
119801|NCT01717807|"     The EGFR is one of the most frequently overexpressed proteins in various cancers including     lung cancer, and is related to tumor progression and resistance to most treatments.      New treatment strategies targeting EGFR have been developed: although much work remains to     be done, erlotinib has already established itself as part of the therapeutic armamentarium     against cancer(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ.     Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)      Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid     in the selection of patients for individualized therapy with EGFR kinase inhibitors.      Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant     tumor burden before the initiation of therapy with EGFR inhibitors.      The purposes of the study are:        1. To adjust an optimal treatment for patients with tumors that have high expression of          EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during          pretreatment work-up; as well as to follow up after treatment response.        2. To recognize patients with advanced pancreatic cancer responding to treatment with          erlotinib and to distinguish them from non-responders.   "
119802|NCT01717794|"     This prospective randomized pilot study is aimed to verify if the operative time of a TLH     with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using     Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and     bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .      Secondary endpoints of this comparison are incidence of intra- or postoperative complications     (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other     Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of     hospitalization and costs for the health care system.   "
119803|NCT01717781|"     This prospective randomized pilot study is aimed to verify if the operative time of a LRH     with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm) and     for advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to neoadjuvant     chemotherapy with complete clinical response could be reduced using Thunderbeat (an     ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar     technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .      Secondary endpoints of this comparison are incidence of intra- or postoperative     complications, estimated blood loss, postoperative pain, days of hospitalization and costs     for the health care system.   "
119804|NCT01717768|"     Low testosterone is a condition that occurs when the body is unable to produce sufficient     quantities of testosterone. The medical name for low testosterone is hypogonadism.     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of     energy and mood swings. The goal of testosterone replacement therapy is to return     testosterone levels to the normal range and relieve symptoms.      The purpose of this study is to evaluate the ability of TSX-002, which is testosterone     provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within     the normal range in hypogonadal men. This will be determined by blood sampling at specified     times during the study. The study is also intended to evaluate the tolerability of TSX-002,     which will be taken orally twice per day for 15 days. In addition, the study is intended to     determine a dosing regimen(s) that achieves testosterone levels within the normal range.     Related Outcome Measures will be reported for Parts 1, 2, and 4.      A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on     the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported     for Part 3.   "
119815|NCT01717625|"     This study is multicentered, prospective, randomized, opened, parallel, intervention study.      The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the     prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational     age.      The investigators evaluate the first effectiveness through the morbidity and mortality of     bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness     through the oxygen index, the usage of mechanical ventilator about taking medicine after 2     Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial     lavage fluid.   "
119909|NCT01716403|"     The risk of severe anemia is increased in patients treated by tri-therapy compared to     patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain     unexplored but could also depend on the global exposure of telaprevir. The trough     concentration or AUC of telaprevir could therefore be a predictive factor of the onset of     anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of     telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve     tolerance and SVR.   "
119805|NCT01717755|"     Rationale: Recently our study group reported the results of the Basilar Artery International     Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic     basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we     continue to lack a proven treatment modality for patients with an acute BAO and that current     clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial     thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute     symptomatic BAO is challenged by our data. The BASICS registry was observational and has all     the limitations of a non-randomised study. Interpretation of results is hampered by the lack     of a standard treatment protocol for all patients who entered the study.      Objective: Evaluate the efficacy and safety of IAT in addition to best medical management     (BMM) in patients with basilar artery occlusion.      Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.      Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar     occlusion.      Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone.     IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of     BMM, IVT should be started within 4.5 hours of estimated time of BAO.      Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin     Score (mRS - functional scale) of 0-3.   "
119806|NCT01717742|"     Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural     empyema) around the lungs in children. The incidence of pleural empyema in children has     increased significantly in the last 10 years.      Short term morbidity for this condition is substantial, but unlike in adults, the long term     outcome of this condition for children in developed countries is favourable. Inserting a     chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down     organized pus has been shown to be an effective therapy for reducing the duration of illness.     However, this treatment is still suboptimal and prolonged hospitalization is common. Recent     data from adults suggests that adding an additional medicine (DNase) to decrease the     viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes;     however, there are no published studies on children.      This is a multi-centre randomized controlled trial comparing the time to discharge from     hospital after chest drain insertion in previously well children who present with pleural     empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest     drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone.     Other outcomes related to effectiveness, safety and cost will be assessed as well.   "
119807|NCT01717729|"     To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and     percutaneous iodine-125 (125I) seeds implantation results in better survival compared with     use of RFA alone in patients with hepatocellular carcinoma.   "
119808|NCT01717716|"     The purpose is to determine the effect of sugars in solution on food intake and subjective     appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food     intake after all sugars-containing solutions will be decreased in comparison to the control     solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and     sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose     or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60     and 90 minutes.   "
119809|NCT01717703|"     The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate     milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when     compared to cola, a fruit drink and a water control in normal weight and overweight/obese     9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal     time satiation to a greater extent than other sugars-sweetened commercially available     beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water,     fruit drink, cola or 1% chocolate milk.   "
119810|NCT01717690|"     The purpose of this study is to determine whether daily bathing with 2% chlorhexidine     gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of     colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus     (MRSA).      Investigators postulate that daily bathing with CHG significantly reduces incidence of     colonization of hospitalized patients with MRSA.   "
119811|NCT01717677|"     4arms preference based Study to compare four therapy options in prostate cancer with low or     early intermediate risk   "
119812|NCT01717664|"     The investigators hypothesize that Mycobacterium avium paratuberculosis positive Relapsing     Remitting MS subjects will have a greater response to Interferon beta-1a therapy plus RHB-104     than from Interferon beta-1a alone.   "
119813|NCT01717651|"     This study is being done to help determine whether patients with severe sepsis (overwhelming     inflammation in the body as a result of an infection) lose muscle and become weak more     rapidly than patients with other severe illnesses. Weakness and muscle loss that develops     after a severe illness is a serious problem. Patients who develop weakness and have a     decrease in muscle size often have to stay in the hospital longer and have a higher chance of     dying. At the current time, it is not clear whether certain severe illnesses are more likely     to cause weakness and muscle loss. This study will be done to measure the changes in muscle     size and strength as a result of each patient's illness   "
119814|NCT01717638|"     It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second     extension study is to explore the bactericidal antibody persistence in 4-year-old children     after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV     NZ administered to toddlers as part of their respective vaccination courses in study     V72P12E1.      In addition, this study will characterize the antibody response to a fifth dose boost in all     children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age     (in parent study V72P12, NCT00721396), and only in a subset of children who received a     three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).     Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ     administered at approximately 4 years of age in all children who received a two catch-up     doses of rMenB+OMV NZ as toddlers in study V72P12E1.      Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2     months apart to healthy naïve children at 4 years of age will be assessed.   "
119910|NCT01716390|"     To determine the effect of investigational products on serum LDL cholesterol.   "
119816|NCT01717612|"     Though histoacryl injection is now regarded as treatment of choice in the control of gastric     variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer     bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On     the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding     gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were     between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without     inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.   "
119817|NCT01717599|"     Pancreatitis is one of the major complications of ERCP. It has been shown that NSAIDs are     potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. The only     one study with IM diclofenac showed reduction of post-ERCP pancreatitis without SOD     (sphincter of Oddi dysfunction) by subgroup analysis in small study population. Therefore the     investigators must need large scaled randomized control study including of SOD.   "
119818|NCT01717586|"     The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters     and collect preliminary safety data for pravastatin when used as a prophylactic daily     treatment in pregnant women at high risk of preeclampsia.   "
119830|NCT01717430|"     Corticosteroid injections into the epidural space or sacroiliac joint are increasingly used     for the treatment of chronic neck, low back, and leg pain. These injections may have several     side effects, including suppression of the body's adrenal glands to produce steroids (adrenal     suppression) and negative effects on metabolism (weight gain, increased blood pressure, and     high blood sugar levels).      The purpose of this study is to determine the time course and predictors of adrenal     suppression and the metabolic effects of corticosteroid injections for chronic pain.      The investigators hypothesize normalization of adrenal function to occur within three weeks     of injection in most individuals. An increased frequency of injections is predicted to lead     to prolonged adrenal suppression. Corticosteroid injections are also hypothesized to lead to     increases in body weight, blood pressure, and blood sugar levels, particularly in diabetic     individuals.   "
120022|NCT01714947|"     This is a 2-part, open-label study in 4 to 6 evaluable patients with advanced solid tumors or     lymphomas. This study is intended to provide a quantitative characterization of the mass     balance, routes of metabolism, and excretion pathways of alisertib.   "
119819|NCT01717573|"     During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The     mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation     and vascular spasm. No reflow is associated with risk factors such as prolonged duration of     ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE     HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration     thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual     care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the     beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will     reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI     patients with risk factors for no reflow and who have given informed consent, when normal     flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon     angioplasty, participants will be randomized to deferred stenting or usual care with direct     stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized     to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and     anti-coagulation with low molecular weight heparin. Patients who are screened and not     eligible to be randomized will be prospectively entered into a registry. Study assessments     for feasibility, safety and efficacy will be prospectively performed. An independent clinical     event committee will review all serious adverse events. Study endpoints will be subject to     core laboratory analyses. The study is intended to inform the design of a larger multicentre     clinical trial.   "
119820|NCT01717560|"     The purpose of this study is to examine the feasibility, safety, and effectiveness of     treating persons who are actively using illicit drugs for hepatitis C using a collaborative,     multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and     minimizing barriers to treatment we can enable drug users to receive effective treatment for     hepatitis C.   "
119821|NCT01717547|"     The aims of this research study are to 1) assess the acceptability and feasibility of     conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs     Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on     Veteran's mental health.   "
119822|NCT01717534|"     The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on     diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind,     placebo-controlled study.   "
119823|NCT01717521|"     Researchers at the UW are doing this study to find out if a commonly used anesthetic affects     patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy     under general anesthesia.      The investigators will administer routine anesthesia care including Ketamine, a commonly used     anesthetic, during the patients surgery. During the patients surgery, the investigators will     monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the     routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely     non-invasive and collects data from the EKG monitor.   "
119835|NCT01717365|"     Data for the study will be collected from therapist across the world. The therapists will     share data they have already compiled from their caseload. Data will be stripped of all     personal identifiers and personal health information. The TWU SCOPE research team has no     contact with clients whose assessment data is being shared for secondary analysis or clinical     data repository. For educational and training purposes clients can be videotaped by the     therapist who will obtain consent and/or assent from the client. Not every client will be     videotaped. The subjects from the data shared by the therapists are from the ages of 0-21,     both male and female, and of any ethnicity. The total amount of data collected from all     participating therapists will be 500 pieces.   "
119836|NCT01717352|"     The present study will test the effectiveness of two different approaches for preparing     overweight/obese individuals for weight loss: 1)providing important information about weight     control, including dispelling common myths; or 2) developing a consistent sleep and eating     routine to prepare for the challenges of a weight control intervention.   "
119824|NCT01717508|"     The goal of the study is to examine how cognitive behavioral therapy (CBT), a common     treatment for adolescent depression, affects brain functioning. Depressed adolescents will     complete an initial assessment consisting of an interview, questionnaires, computer tasks,     and an EEG recording. EEG (electroencephalography) measures brain activity by recording the     electrical activity along the scalp caused by the firing of neurons within the brain. They     will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long     and held once a week for 12 weeks. Before their third therapy session, participants will     complete a computer task while EEG data are recorded. After completing the treatment, the     participants will complete a final assessment, which will include questionnaires, computer     tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1,     3, and 6 months after completing the treatment.      This study will also include healthy control participants. They will complete an initial     assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording.     Three weeks later, they will return to complete a behavioral task while EEG data are     recorded. Twelve weeks after the initial assessment, they will complete a final assessment,     which will include questionnaires, computer tasks, and an EEG recording.   "
119825|NCT01717495|"     This is a large prospective registry of patients submitted to cardiac electronic devices     implantation designed to investigate the incidence, risk factors and prognostic of     thromboembolic complications associated with transvenous lead implantation.   "
119826|NCT01717482|"     The purpose of this study is to learn whether it is better to receive the drug Metformin with     standard of care for lung cancer or just standard of care.   "
119827|NCT01717469|"     Previous experimental and clinical studies have consistently suggested that right ventricular     (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required,     and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is     a randomized controlled trial that compare the effects of conventional right ventricular (RV)     pacing vs. left ventricular (LV) in patients with AV block.   "
119828|NCT01717456|"     In previous studies at a university referral center the investigators demonstrated that a     multicomponent conservative treatment for fecal incontinence was effective. The treatment     combines patient education with medical management of diarrhea and constipation plus     behavioral training. The purpose of this study is to determine whether this treatment is     effective when delivered by home health care nurses to frail elderly patients.   "
119829|NCT01717443|"     The purpose of this study is to examine the prevalence, incidence and genotype of anogenital     HPV infections in women before and after renal transplantation. With this information the     investigators can determine the value of vaccination in patients waiting for renal     transplantation in the future.   "
119844|NCT01717248|"     The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic     kidney disease.   "
119900|NCT01716520|"     The purpose of this study is to evaluate the lung function response to UMEC/VI, UMEC, and VI     in individual patients using a cross-over design. This is a multicenter, randomized,     double-blind, 3-way crossover study. Eligible subjects will be randomized to a sequence of     UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg. All subjects will receive each treatment     once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period.     There will be a 5-7 day run-in period prior to randomization.   "
119831|NCT01717417|"     Maxillary canines are the second-most frequently impacted teeth in the dental arch after the     third molars. The suspicion of a maxilary canine impaction raises with the absence of the     permanent canine in the arch after the normal period of eruption, and has to be confirmed by     a clinical evaluation of the patient and a radiographic assessment.      The approaches to the management of impacted canines are many, but the preferred approach     typically involves surgical exposure and guided orthodontic eruption.      The initial mechanical eruption can be achieved in several ways, but an important distinction     has to be done according to the anchorage method. The aim of this study is comparing     Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using the     quantification of canines and molars displacement as the main parameter.      A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic     anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the     need for it at large, and is subsequently removed after use.      The mini screw employed in this clinical trial will be an alloy type IV titanium screw with     1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area between     the first premolar and first molar, on the buccal or labial side according to the canine     position and teeth position.      For the evaluation of the canines and molar displacement, two CBCT will be required: the     first one before the beginning of the traction (T0), the second one after three months (T1).     Both the CBCT will be imported in the MIMICS image processing software (Materialize Group,     Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of     interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration,     through the identification of 5 at least landmark points, will allow the overlap of the two     masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment     positions will be evident and the measurement of the displacement possible.   "
119832|NCT01717404|"     To understand if Mexiletine will restores normal colonic motility in a patient with irritable     bowel syndrome - constipation (IBS-C) and a genetic mutation in SCN5A.   "
119833|NCT01717391|"     [F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan     to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone     marrow will help maintain blood counts. This would impact chemotherapy administration.   "
119834|NCT01717378|"     The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides     recruitment services and facilitates the enrollment of research participants into UCSF     clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and     affiliated institutions and will address the common problems that investigators encounter in     the recruitment process.      Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA     regulations for ensuring human subject rights, participant privacy, and data security into     the recruitment workflow and data collection/extraction methods. Recruitment Services,     therefore, requests approval to implement these processes systematically for all studies that     have already obtained CHR approval to begin recruitment activities.   "
119864|NCT01716988|"     A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment     success in ICU patients compared with non-ICU patients. It is known that in critically ill     patients, alterations in function of various organs and body systems can influence the     pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters     of micafungin in critically ill patients are most likely different, but this has not been     specifically studied.      The pharmacokinetic parameters of micafungin in critically ill patients will be established     and plasma concentrations of micafungin will be correlated with disease severity.   "
119837|NCT01717339|"     Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development     of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but     given the association between OSA and obesity, adipose-derived hormones (adipokines) are     likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown     to be associated with deleterious effects on vascular function resulting in impaired     endothelial function. This proposal is directed at investigating the molecular mechanisms of     endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction     associated with OSA is a result of molecular alterations within endothelial cells. As a part     of these studies we will look at NO signaling pathways in adipose tissue and microvessels     from normal and OSA subjects.   "
119838|NCT01717326|"     This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with     elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained     Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the     treatment arms.   "
119839|NCT01717313|"     The purpose of this study is to assess the safety and efficacy of omarigliptin (MK-3102),     dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and     exercise. The primary hypothesis is that after 24 weeks, treatment with omarigliptin compared     with placebo provides greater reduction in hemoglobin A1c (A1C).   "
119840|NCT01717300|"     This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density     lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in     participants with hypercholesterolemia when added to an existing statin-modifying therapy.   "
119841|NCT01717287|"     This multicenter, open-label, noncomparative study evaluates two oral formulations of     raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other     antiretroviral agents for safety, tolerability, and antiretroviral activity in     treatment-naive or treatment-experienced Russian children and adolescents infected with human     immunodeficiency virus-1 (HIV-1).      As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the     treatment of HIV-1 infection in pediatric patients in the United States (US), this study is     designed to gain local treatment experience on the use      of raltegravir in the pediatric HIV-infected population in Russia.   "
119842|NCT01717274|"     Many methods have been used to reduce bleeding during sinus surgery (FESS) in order to allow     for the best surgical view and to reduce risk while in surgery.      Warm irrigation fluid is believed to accelerate the clotting mechanism in the human body. The     investigators would like to determine if hot saline irrigation (HSI) compared to room     temperature saline irrigation (RTSI) can control bleeding during FESS.      The hypothesis is that HSI is more effective than RTSI in reducing intraoperative bleeding     during FESS.   "
119843|NCT01717261|"     The purpose of this study is to determine if partial breast irradiation administered in a     single preoperative fraction is tolerable.   "
119845|NCT01717235|"     Study subjects were screened and enrolled for the study. Subjects were housed in the clinical     facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each     period. After maintaining at least 10 hours of overnight fast Test or Reference product was     administered orally (as per the randomization schedule) to each subject with about 240 mL of     water at ambient temperature in each period by trained study personnel.      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were     collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,     10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period     with a washout period of 7 days between the dosing of two periods. Subjects were continuously     monitored for well being i.e., blood pressure, radial pulse and oral temperature before     check-in, prior to drug administration and at regular intervals post dose in each period. The     concentration of Ropinirole in plasma samples obtained from study subjects was determined     using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on     obtained drug concentration data, using appropriate software.   "
119846|NCT01717222|"     Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall     stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and     intravenous administration of lignocaine has been used. But it is not clear from the existing     literature which form of administration is more effective for pain relief. Hence this study     has been undertaken with the following hypothesis : Intravenous lignocaine is superior to     intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response     in laparoscopic cholecystectomy.   "
119847|NCT01717209|"     Research study evaluating the individual and combined effects of inhaled medications, nitric     oxide and prostacyclin, on the function of the right heart after surgery for either heart     transplant or for left ventricular assist device (LVAD) placement. The investigators hope to     learn if these two medications, when given together after surgery, improve right heart     function by lowering blood vessel pressures in the lungs. The investigators hope to learn if     the combined effects of these two medications are better than either medication used alone.     Participants were selected as a possible participant in this study because right heart     problems are common during and after surgery for heart transplant and for LVAD placement. In     addition, the inhaled medication, nitric oxide, is always given during and after these two     types of surgeries at Stanford to help improve how the right heart functions.   "
119865|NCT01716975|"     The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the     cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic     therapy.   "
119866|NCT01716962|"     Fluid responsiveness (FR)refers to the ability of heart to increase its stroke volume in     response to volume load.Low tidal volume and high PEEP exerts contrast effect on the     prediction of fluid responsiveness, the aim of this study is to compare the relative     predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and     pleth variability index (PVI) on the fluid responsiveness of acute respiratory distress     syndrome ventilated with various PEEP levels or various tidal volumes.   "
119921|NCT01716247|"     The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM)     will be able to detect smaller/earlier breast cancers as well as breast MRI can.   "
119922|NCT01716234|"     The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and     tolerability of oral posaconazole in immunocompromised children with neutropenia or expected     neutropenia.   "
119848|NCT01717196|"     BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic     masses. Different needle diameters and the use of stylet are not associated with differences     in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction     (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare     EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different     aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and     complications.      METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo;     Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was     performed by five experienced echo-endoscopist. The needle system was in all cases the 22     gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume     aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no     aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples     were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the     slides, the material was fixed in formalin for cyto-histological evaluation. The     cyto-pathologist was always blinded as to which aspiration was used for which specimen. After     EUS-FNA the patients were monitored for at least six hour to detect immediately     post-procedural complication and were followed up during the 30 days post-procedure in order     to detect late complications.   "
119849|NCT01717183|"     The main purpose of this trial is to demonstrate that the new dressing is more effective than     the current dressing in the local treatment of chronic foot ulcers in diabetic patients.   "
119850|NCT01717170|"     In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity     of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with     non-infectious intermediate, posterior, or panuveitis.   "
119851|NCT01717157|"     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of     4 new formulations of fentanyl transdermal patch in healthy participants after a single     application for 72 hours.   "
119852|NCT01717144|"     Parkinson's disease (PD) has considerable impact on motor, psychological and social     activities and significantly affects the quality of life of patients and their families. To     improve the medical care of PD patients, the investigator have developed an educational     program specific to PD.      The principal aim of this study is to evaluate the therapeutic education Program, comparing     the quality of life of PD patients with or without the educational program after six month     and one year follow-up.      The secondary aims are to evaluate the evolution of motor and psychological states in these 2     groups of patients and to compare the medical costs.      This is a monocentric, comparative, prospective randomised study. The investigators will     evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients     with a traditional medical care. Quality of life of PD patients is evaluated using a specific     scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological     states were assessed with UPDRS and HAD Scales. The educational program consisted of both     individual and collective educational consultations.      The investigators supposed that the therapeutic education program will improve the quality of     life of PD patients. The supposition that this improvement will correlate with the motor and     psychological states.   "
119893|NCT01716611|"     The purpose of the study is to investigate the efficacy and safety for the management of     hyponatremia and ascites in patients with liver cirrhosis.   "
119894|NCT01716598|"     Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve     trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve     targeted lung denervation and potentially improve breathing and quality of life for patients     suffering from COPD.      Use of the IPS System will be technically feasible in accessing the target treatment location     and delivering RF energy to the target treatment location.   "
119901|NCT01716507|"     This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation     for retinal detachment repair.   "
119853|NCT01717131|"     Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the     hypothesis that omission of additional axillary dissection in case of positive sentinel node     has a limited impact on overall survival and relapse free survival. However, these data are     not sufficient enough to recommend, as a standard of care, to avoid axillary dissection in     case of positive sentinel node. The ASCOG Z0011 trial has been closed before the end of     inclusions and the predefined non inferiority margin was found to be too large (5% difference     at 5 years for primary endpoint).      Prospective randomized trial is then urgently mandatory before omission of axillary node     dissection becomes a usual practice without a sufficient scientific level of proof. Indeed,     in several reviews, the rate of omission of axillary node dissection in case of     micrometastasis increased (Bilimoria) despite any strong proof has been demonstrated.      The omission of axillary node dissection in case of positive sentinel node may have strong     practical impacts on patients but also on medical and economical aspects: in avoiding a     prolonged hospitalisation, secondary morbidities due to axillary dissection requiring     secondary care and their costs, as well as costs for secondary axillary dissection (14 to 25%     in case of positive sentinel node) and finally shortening surgery duration.      The main investigator propose a Non Inferiority Randomized Multicenter Phase III Trial of     Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel     Lymph Node in Invasive Breast Cancer   "
119867|NCT01716949|"     This trial examines the feasibility, effectiveness and safety of a combination of     radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and     Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally     advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local     recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively     improved tumor regression allowing less aggressive surgery in primary locally advanced rectal     cancer and a higher rate of curative resections in heavily pretreated locally recurrent     rectal cancers.      Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of     radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates,     and toxicity. It is planned to include a total number of 59 patients over a period of 2.5     years.   "
119868|NCT01716936|"     The purpose of this study is to determine the safety profile and probable benefit of the     Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity     associated with thoracic insufficiency syndrome.   "
119854|NCT01717118|"     In September 2009 the National Vaccination Council approved the policy for anti-HPV     vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the     following justification:        -  Antibody induction due to the vaccine is greater than that produced by natural exposure          to the virus        -  Immune response in girls 9 to 11 years of age is similar to the response obtained after          three doses in women 16 to 26 years of age        -  The third dose will be administered at the time when maximum protection is required,          near the onset of sexual activity Thus the National Institute of Public Health was          commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV          vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared          with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a          sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and          stratified by vaccine type. The hypothesis is that in 9-year-old girls who are          administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels          that are not lower than those of adult women who have been administered the traditional          scheme (0-1/2-6).      The main objectives are to monitor the levels of immunity induced by vaccination against HPV     with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60     months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against     HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional     (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent     and quadrivalent vaccines in the third dose of extended scheme. The study design is to create     a sentinel cohort of women vaccinated against HPV in the following comparison groups:        -  Women of nine years with extended vaccination scheme with three doses of quadrivalent          vaccine (0-6-60)        -  Women of nine years with extended vaccination scheme with two doses of the quadrivalent          vaccine and the third dose with bivalent (0-6-60)        -  Women of nine years with traditional vaccination scheme with the quadrivalent HPV          vaccine (0-2-6)        -  Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent          HPV vaccine (0-2-6)        -  Women of nine years with extended vaccination scheme with three doses of bivalent          vaccine (0-6-60)        -  Women of nine years with extended vaccination scheme with two doses of bivalent vaccine          and the third tetravalent dose        -  Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)        -  Women of nine years with traditional vaccination scheme with bivalent HPV vaccine          (0-1-6)        -  Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV          vaccine (0-1-6)        -  To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15          years, who have not been vaccinated against HPV, will be invited , in order to make the          monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post          dose 0 in vaccinated groups   "
119855|NCT01717105|"     The present study has been designed in order to characterize the incidence of patients with     advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR)     positive mutations and their clinical management in Galicia.   "
119856|NCT01717092|"     Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable     morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors     are not well documented in Chinese population. We conducted a prospective, long-term,     follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an     acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with     unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and,     if supportive findings were present, ventilation-perfusion lung scanning and pulmonary     angiography. CTPH was considered to be present if systolic and mean pulmonary-artery     pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure     was normal; and there was angiographic evidence of disease.   "
119857|NCT01717079|"     Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder     characterized by a resistance to maintaining body weight at or above a minimally normal     weight for age and height, an intense fear of weight gain or being fat even though     underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in     the experience of body weight or shape. Body weight and shape dissatisfaction is linked to     the development, maintenance and relapse of AN. Neuroimaging studies have shown that the     inferior parietal cortex is involved in body image perception and less activated in patients     with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS)     is used to modulate cortical excitability, and particularly to increase excitability with     high-frequency rTMS. The aim of this study was to investigate the effect of excitatory     high-frequency rTMS over the hypoactive inferior parietal cortex of 54 patients with AN.      This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000     ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10     sessions in two weeks) versus placebo rTMS.      Assessments will be performed before rTMS and after the last rTMS session (immediately after,     at 15 days and three months). The principal criteria for judgement is a body image     satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement     are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating     Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating     scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis     using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker     for eating disorders recently described).      Inferior parietal cortex rTMS could not only improve body image perception, but also help in     the treatment of eating disorders, allowing weight gain with a decreased anxiety and     improving patients' quality of life. Also positive results could have direct therapeutic     implications with the possibility to complete regular rTMS sessions, or to implant extradural     electrodes for chronic parietal cortex stimulation.   "
119858|NCT01717066|"     Using the subject with hepatocellular carcinoma in the conventional therapy to evaluate the     efficacy and safety of ginsenoside Rg3 (20mg BID) and placebo in prevention and treatment of     postoperative recurrence of liver cancer,respectively   "
119859|NCT01717053|"     The addition of abiraterone acetate to standard treatment of radiotherapy and short-term     androgen deprivation will increase the frequency of undetectable PSA.   "
119860|NCT01717040|"     The primary objective is to test the hypothesis that adjunctive pioglitazone is more     effective than placebo for the relief of acute depressive symptoms resulting from bipolar     disorder. The secondary objectives are to determine potential moderators and mediators of     antidepressant efficacy.   "
119861|NCT01717027|"     To estimate the pharmacokinetics and relative bioavailability of oxycodone after     administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions     and after chewing under fasted conditions in healthy volunteers   "
119862|NCT01717014|"     The purpose of this research study is to evaluate the safety and feasibility of the Radial     Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires     relating to the function of the device.   "
119863|NCT01717001|"     A better understanding of knee joint kinematics is important to explain the premature     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a     prosthesis that most closely approximates the normal knee. Previously, most experimental     studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the     knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that     permit error due to undesired motions between markers and the underlying bone. More recently,     fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.      ConforMIS has attempted to follow a clearly different path than the major orthopaedic     companies. They have chosen to offer patients a personalized knee implant based off of each     patient's femoral and tibial bone geometry. The hypothesis is that these subjects will     experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding     during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the     in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25     patients implanted with a traditional TKA design to determine if there are any kinematic     differences between these TKA designs.   "
119869|NCT01716923|"     The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the     European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate     the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC     transfusion support for acute anemia.   "
119870|NCT01716910|"     This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week     clinical trial on healthy volunteers. Following a two week run-in-period, subjects were     randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a     3-week wash-out period before the second treatment period, followed by a another wash-out     period. Volunteers completed questionnaires for each period on overall health and well being,     stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to     collect fecal samples for investigation of microbiological and microbial metabolites before     and after three treatment periods. The primary objective of the study is tan increase in     fecal butyrate concentration. Secondary objectives are changes in microbiota composition and     short-chain fatty acids.   "
119871|NCT01716897|"     This study will be a single-center, open-label, randomized, 3-treatment crossover study of     single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet     formulation administered under fed and fasted conditions in healthy subjects.   "
119872|NCT01716884|"     1. Registration        2. Performing in three stages        3. Major aim: Much more and standard reperfusion therapy in STEMI patients   "
119873|NCT01716871|"     Introduction: The military population is at high-risk for injury with by painful sprains,     especially of the ankle. The referenced treatment method for pain is the cryotherapy,     consisting in applying cold-packs to the injured ankle several times a day. However, another     pain treatment has been developed and is commonly used by high-level sports teams and     rheumatologists but its efficacy has never been assessed within a military population, i.e.     the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.      Research design: This study was carried out on a French multicenter basis, the study     consisting in a randomized controlled superiority trial and open-label prospective analysis     in the treatment of 40-year-old military patients or younger suffering from acute ankle     sprains. Two groups were made: patients were treated either by neurocryostimulation or by the     referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six     supervised 30 minute-sessions within a period of three consecutive days.      Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity     resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we     theorized that the total consumption of paracetamol and the number of days of temporary     inaptitude and of work exemption were lower in patients treated by neurocryostimulation.      Outcomes:      For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning     and at the end of session 20 minutes later after a four-step walk.   "
119874|NCT01716858|"     Accumulating evidence suggests a role of oxidative stress in the pathophysiology of     schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived     from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels     sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation     of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II     detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as     the electrophilic responsive element or antioxidant responsive element. Recently, we reported     that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist     phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that     SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to     determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with     schizophrenia.   "
119875|NCT01716845|"     This study will prospectively enroll approximately 660 children, at least 18 months and less     than 5 years of age, who have been referred to a pediatric developmental evaluation centers.     Enrolled children will have blood drawn for RNA gene expression analysis and undergo a     clinical evaluation to determine the presence or absence of a diagnosis of ASD.      The sequential co-primary objectives of this study are:        -  To develop an algorithm to classify blood RNA gene expression patterns to maximize          agreement between the classification and a clinical assessment of presence or absence of          Autism Spectrum Disorders (ASD).        -  To prospectively assess the clinical sensitivity and specificity of the blood RNA gene          expression classification algorithm (the SDX-002 test) in children referred to a          developmental evaluation clinic for a possible developmental disorder.   "
119876|NCT01716832|"     The effectiveness of a mindfulness walking program is tested in subjects with a high level of     subjectively perceived stress.   "
119877|NCT01716819|"     R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular     remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin     aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to     confirm the hypothesis that RAAS is associated with an early remodelling and implicated in     the transition to cardiac failure in abdominal obesity.   "
119878|NCT01716806|"     This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy     and safety of brentuximab vedotin as a single-agent (Part A) and in combination with     dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of     HL in adults age 60 and above.   "
119879|NCT01716793|"     In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years,     the Spanish CETLAM group showed a complete remission rate 75 % using the combination of     daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous     infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3     days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up     to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing     in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during     induction and risk-adapted post remission treatment based on the improvement in prognostic     characterization of AML and the implementation of novel transplantation techniques.   "
119908|NCT01716416|"     This phase I trial studies the side effects and best dose of pazopanib hydrochloride     (pazopanib) when given together with cetuximab in treating patients with incurable recurrent     or metastatic head and neck cancer. Pazopanib may stop the growth of cancer by blocking blood     flow to the tumor. Pazopanib may also block some of the enzymes needed for cell growth.     Cetuximab is a monoclonal antibody that blocks the ability of some tumor cells to grow and     spread. Giving pazopanib with cetuximab may provide a more effective treatment for patients     with advanced head and neck cancer.   "
119880|NCT01716780|"     This study is looking at treating cancer pain in head and neck cancer. Patients are asked in     outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. Those with     a pain score of 4 and above are randomised into the study.      Patients are allocated to continue with their current care (control group) or to be reviewed     by the pain/palliative care team (intervention group). At baseline questionnaires are     completed on level of pain, type of pain, quality of life and anxiety/depression. Information     is also collected on the analgesia they've used in the past month and basic health economics     (GP/hospital visits related to pain management and treatment).      Follow up in the trial is for 3 months and consists of questionnaires as above and further     collection of information on analgesic usage and health economics.   "
119881|NCT01716767|"     Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the     musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here     the investigators examine - in a double-blind randomized controlled cross-over trial - the     acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain     symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.   "
119882|NCT01716754|"     This study assessed the effect on asthma control of different dose levels and regimens of     QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2     agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab.     Information from this study was planned to support the design of future studies.   "
119883|NCT01716741|"     Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient     encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups     of patient who are of high clinical suspicion for undiagnosed Gaucher disease. A group of     potential participants will be identified through the PDR. Detailed records will be requested     to further narrow to ideal participants based upon previously existing diagnoses and     symptoms. Participants will be invited to partake in the study via a letter from their     Partners care provider with supporting study details. Study participants will be evaluated in     a one-time visit. A complete family and medical history will be collected. A physical exam     will be performed, and up to 20cc of blood will be drawn. All participants will be notified     of their disease status via letter and phone call from the study staff. If the study     participant is diagnosed with GD through this evaluation, proper follow-up recommendations     and referrals will be provided. Our intent is to determine if existing patient data can     successfully be utilized to aid in the identification of patients with rare genetic disease.   "
119895|NCT01716585|"     The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and     ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as     dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected     treatment-naïve adults.   "
119896|NCT01716572|"     The researchers will investigate whether erythromycin infusion is better than gastric lavage     prior to emergency endoscopy to improve the quality of examination in patients with upper     gastrointestinal bleeding.   "
119884|NCT01716728|"     Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient     encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups     of patient who are of high clinical suspicion for undiagnosed lysosomal acid lipase     deficiency. A group of potential participants will be identified through the PDR. Detailed     records will be requested to further narrow to ideal participants based upon previously     existing diagnoses and symptoms. Participants will be invited to partake in the study via a     letter from their Partners care provider with supporting study details. Study participants     will be evaluated in a one-time visit. A complete family and medical history will be     collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All     participants will be notified of their disease status via letter and phone call from the     study staff. If the study participant is diagnosed with LALD through this evaluation, proper     follow-up recommendations and referrals will be provided. Our intent is to determine if     existing patient data can successfully be utilized to aid in the identification of patients     with rare genetic disease.   "
119885|NCT01716715|"     This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel     works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube,     or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or     paclitaxel is more effective at treating patients with persistent or recurrent epithelial     ovarian, fallopian tube, or primary peritoneal cavity cancer.   "
119886|NCT01716702|"     Background: Prostate cancer (PCa) is the most common cancer for men. When treated early     enough it is typically curable. However, common treatments, such as radical prostatectomy and     radiation therapy, often result in significant negative outcomes with regard to sexual,     psychological and social function. Both men and partners have identified the need for more     information and support to address sexual health concerns after treatment. However, very few     sexual rehabilitation interventions have been developed and rigorously assessed.      Purpose: The investigators propose to develop and pilot test a new program to meet the sexual     health needs of men with PCa and their partners using an online, professionally facilitated     education/support program. The goals of the program are to improve sexual function, intimacy     and mood for men and their partners after treatment for localized PCa. The program will be     offered through Cancer Chat Canada, an existing and well-tested Canadian platform for     professionally facilitated support group programs.      What Participants Can Expect: A total of 24 men and their female partners (48 individuals)     will be recruited and assigned to one of two groups. The first group will participate in the     program immediately; the second group will be offered the program after a 5-month delay. The     decision about which group will start immediately and which later will be made randomly (by     chance). Both groups of men and partners will be asked to complete questionnaires three times     and, at the end of the program, to provide the researchers feedback about how satisfied they     were with the program, the changes they made, things they learned as a result of the program,     and suggestions for improving the program. Participants must have access to a computer, an     Internet connection and be willing to attend online, chat room meetings each week for 1.5     hours for 6 weeks.      Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult     to access. The investigators hope to improve access to sexual health care through this study.   "
119887|NCT01716689|"     This is a single arm phase II clinical study to evaluate the efficacy and safety of     metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced     sarcomas.   "
119923|NCT01716221|"     The purpose of this study is to document the clinical effects of bupropion and citalopram in     a single subject with Friedreich Ataxia.   "
119888|NCT01716676|"     In recent years medicine has been enhanced by the incorporation of technological innovations     from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering.     One of the few exceptions in this rapid process of implementing technological advances occurs     in clinical medicine, where its penetration is much less effective than in other scientific     and professional fields, or even in everyday life. Attempts to tackle this problem have given     rise to various initiatives in the US and Europe, including Spain.      There is a surprising paucity of telemedicine systems in clinical practice, especially with     respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea     (OSA), where protocols are urgently needed to alleviate this healthcare problem represented     by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In     others words, the growing awareness of sleep disorders, especially OSA, has not been     accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these     diseases.      CPAP therapy compliance is not always appropriate. Helping patients during the first two     months usually determines compliance. Therefore, the development of strategies to support the     patient during the first weeks is essential. However, this collides with reality, where it     is difficult to properly care all patients because of congested sleep units. It is therefore     necessary to implement new and imaginative control schemes especially at the beginning of the     treatment. Patients' follow-up performed by telemedicine technology is an option that aims to     substitute the face-to-face visits or at least reduce them considerably. In a future context,     the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda     face-to-face visits and televisits (at distance) and information which patient will provide     through online questionnaires with a certain frequency.      In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients     monitored by telemedicine techniques (website and televisits) is similar to that achieved by     standard monitoring but more cost-effective. The study design is a multicenter randomized     trial with parallel groups and blind final evaluation after CPAP treatment following two     different strategies: one through conventional monitoring in the hospital (face-to-face     visiting) and another by telemedicine monitoring (non-contact visiting and website).   "
119889|NCT01716663|"     This is a prospective, multicenter, non-randomized observational study of subjects 18 years     and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial     Fibrillation (AF).   "
119890|NCT01716650|"     To assess the pain scores before and after saphenous nerve block placement in patients with     degenerative joint disease of the ankle   "
119891|NCT01716637|"     While the cause of AD is still unknown, evidence suggests it develops because of a complex     series of events in the brain that occur over time. Two pathways possibly involved in     development of AD are inflammation and oxidative stress. Scientists have linked chronic     inflammatory events in the brain with the onset and progression of Alzheimer's Disease.     Oxidative stress has also been implicated in the pathogenesis of a number of neurological     disorders including Alzheimer's Disease.      Etanercept (Enbrel®) is an approved drug for the treatment of several forms of arthritis when     administered by injection. Some research suggests that etanercept, when administered by     injection into the tissues close to the spinal column (perispinally), may modulate certain     aspects of the immune system and provide some beneficial effect for people with Alzheimer's     disease. Studies suggest that supplementation with specific nutrients may also have a     positive effect in support of cognitive function.      This study will be conducted at one research office with volunteers who have been diagnosed     with mild to moderate Alzheimer's disease. Each qualifying participant will be randomly     assigned to receive an etanercept injection plus nutritional supplements for 6 weeks followed     by a crossover and a washout period of 4 weeks to then receiving nutritional supplements     alone or vice versa for another 6 weeks.      Participants will undergo blood and urine safety assessments at the beginning and end of each     6 week treatment period. During 4 of the 6 weekly visits in the treatment period with the     injections, you will complete the cognitive tests twice; once before and once 2 hours after     the injection. During 4 of the 6 weekly visits in the treatment period without the     injections, you will also complete the cognitive tests twice; once before and once 2 hours     after being asked to lie down onto a table for 5 minutes. You will be allowed to continue     your standard of care for Alzheimer's disease throughout your participation in the study.   "
119892|NCT01716624|"     The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy     for children with neurogenic bladder due to spina bifida and compare results with standard     oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain     or improve bladder storage function without side effects associated with oxybutynin use.   "
119903|NCT01716481|"     The objectives of this study was to test hypothesis that ischemic stroke patients having     moderate to severe persistent neurologic deficit will have better outcomes with intravenous     transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum     that is obtained at acute phase of stroke than patients receiving standard treatment.   "
119904|NCT01716468|"     The purpose of this study is to determine the safety and tolerability of a modified low     carbohydrate diet, determine if quality of life is improved and to determine if the diet has     any effect on tumor growth (size or spread) and or to determine if there is any effect on     progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.   "
119905|NCT01716455|"     Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of     chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias.     The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701)     following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly     subjects and in adult subjects with mild, moderate, severe, and end stage renal disease     (ESRD) degrees of impaired renal function. The results of this study will characterize the     pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with     various degrees of renal impairment, and these data will be compared to healthy adult and     elderly subjects.   "
119906|NCT01716442|"     Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS)     on the basis of favorable clinical observations. Yet the long-term effect on maintaining     remission or the likelihood of becoming rituximab-dependent is unclear and the information on     the safety profile of rituximab is limited. This trial was designed to investigate the safety     and efficacy of Rituximab in children with refractory NS.   "
119907|NCT01716429|"     This study will be a 6-month intervention that is examining how different dietary approached     may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy,     particularly by measuring changes in weight. Participants will be randomly assigned to     following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight     loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat,     low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products     (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits,     vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic     index, which means the consumer will be asked to favor foods that don't cause a quick rise in     blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will     receive counseling and supporting materials on the dietary approach the participants are     assigned to follow. Both diets are safe and have shown to be effective ways to assist with     achieving a healthy weight. The investigators hypothesize that both groups will see     improvements in weight and fertility with possible greater improvements seen among     participants in the vegan group.   "
119911|NCT01716377|"     Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine     administration in reducing acute and chronic musculoskeletal pain in individuals presenting     to the ED for evaluation after motor vehicle collision.      Participants: Participants will consist of 60 patients between the ages of 18-50 who present     to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain score     > 6 will be screened for further eligibility.      Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60     high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of     venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed     during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6 weeks,     4 months, and 6 months post-MVC.   "
119912|NCT01716364|"     Patients with some forms of acute myeloid leukemia (AML) and multiple myeloma (MM) are not     cured with conventional therapy and new approaches are needed. For the last 15 years we have     investigated the potential of using a patient's own T cells (a type of white blood cell     [WBC]) to eradicate the tumor. We have demonstrated the feasibility of this approach in cell     culture and animal models of AML and MM. Over the last 5 years we have been preparing to     treat patients as part of a Phase I (first in human) clinical trial.      The trial treatment involves collecting the patient's own WBCs from the blood by a standard     well established and safe process called apheresis. The cells are then cultured in a     specialized laboratory (under Good Manufacturing Practice conditions, similar to standards     under which pharmaceuticals are produced) over 12 days to convert the cells to specialized     tumor-attacking T cells. Early in that culture process the cells are exposed to a virus (that     is modified so that it cannot infect or replicate outside the special culture conditions)     that contains a special gene. Via the virus, this gene inserts into the patient's T cells in     culture and gets incorporated into the T cell's genetic machinery. As the T cells replicate,     the new gene produces a protein receptor that becomes part of the patient's T cells. This     protein receptor on the T cells has the capacity to specifically recognize and bind to a     protein on the leukemia or myeloma cells called the Lewis Y antigen.      After the modified T cells are infused into the patient, they home into the bone marrow (this     tracking is monitored by special radiological techniques) where the new protein receptor on     the T cell surface can recognize and bind to the cancer cells (which express Lewis Y). Once     bound onto the cancer cells, the T cells get activated and subsequently replicate and kill     the cancer cells. The novelty of this approach is that the T-cells will only kill cells that     have the Lewis Y on their surface - the cancer cells. Moreover, because there are few normal     cells in a person's body that carry Lewis Y, this treatment is likely to only have minor side     effects.      This gene therapy trial is unique and although the primary purpose is to test the safety of     this approach, patients will be monitored closely for anti-tumor responses. As the trial     progresses, the dose of T cells infused will increase, in the hope that this will result in a     better and stronger immune response to the leukemia or myeloma.   "
125934|NCT01636687|"     The purpose of this study is to demonstrate efficacy of autoinjector administered secukinumab     at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to     severe chronic plaque-type psoriasis.   "
119913|NCT01716351|"     Psychosocial risks are significant in the management of patients with cardiovascular disease     and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled,     clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly     reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of     life in ICD patients. The specialized, real-time data, collected by the device provides a     unique look at the electrophysiological parameters of each patient's heart.   "
119914|NCT01716338|"     Glyburide is a medication that has been safely used for several decades to treat non-insulin     dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the     lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and     cognitively. The investigators are hopeful that the results of this study will provide the     necessary foundation to evaluate this medication's use on a larger scale to determine the     feasibility of using glyburide in soldiers either prophylactically or for the treatment of     brain injury.   "
119915|NCT01716325|"     The purpose of the study is to establish and clinically evaluate a new approach to treating     obesity by using information and communication technologies (ICT). A mobile environment and     organizational interventions to improve the process of an integrated treatment of people with     obesity will be identified, developed, introduced and clinically evaluated.   "
119916|NCT01716312|"     Background:        -  Systemic Lupus Erythematosus (SLE or lupus) is an autoimmune disease, which means the          body's immune system mistakenly attacks healthy tissue resulting in inflammation and          tissue damage. SLE can involve almost any organ and its symptoms can range in severity          from mild to life-threatening; symptoms also vary from person to person. Current          treatments for lupus are not effective for some people. Medications used to treat lupus          can have serious side effects.        -  Omalizumab is a drug that has been used to treat severe allergic asthma. It helps to          prevent allergic reactions by reducing some antibodies in the blood. These antibodies          are also present in some people with Lupus. Researchers want to see if omalizumab is a          safe and effective treatment for people with Lupus.      Objectives:      - To test the safety of omalizumab for people with lupus.      Eligibility:      - Individuals at least 18 years of age who have moderately active Lupus even with standard     treatments.      Design:        -  Subject screening will take place at the NIH Clinical Center and will include a medical          history, a physical exam, blood and urine laboratory tests, an assessment of Lupus          disease activity. Some participants may require some additional testing. All eligible          persons who are interested in enrolling will be asked to come back to the NIH within 2          weeks to begin the study.        -  The study will be conducted in three phases, with a total of 15 study visits over 38          weeks. Two visits will be overnight hospital stays. The rest will be outpatient visits.          During each visit the participants will be monitored by doing a physical exam,          assessment of their lupus disease activity, review of any treatment related side          effects, blood and urine testing.        -  For the first phase, participants will have infusions (under their skin) of either          omalizumab or a placebo. They will have an overnight hospital stay for the first          infusion and then an outpatient safety monitor visit 2 weeks after. If subjects safety          measures are good they will return in 2 weeks and receive the second dose. They will          then get three more doses every 4 weeks which will be given during outpatient visits to          the NIH.        -  In the second phase, which begins at the 16th week of the study, all participants will          receive omalizumab. This means that subjects who had been getting omalizumab will          continue receiving it and subjects who had been receiving the placebo will now begin          getting omalizumab. They will have an overnight hospital stay for this infusion and will          return in 2 weeks for a safety monitor visit. If subjects safety measures are good they          will return in 2 weeks and receive the next dose. They will then get three more doses          every 4 weeks which will be given during outpatient visits to the NIH.        -  The third phase will be a final series of visits which will take place at week 32 and          week 36. During these visits subjects will have a physical exam which includes disease          activity assessment, blood and urine tests. No medication will be given during these          visits.        -  All subjects will be given information, instruction and medications for possible          allergic reactions to omalizumab.        -  Throughout the study other tests and procedures will be performed as needed.   "
119917|NCT01716299|"     The primary objective of the study is to assess whether an improved MSF HIV diagnostic     algorithm which includes a simple and easy to perform confirmation test has significantly     better positive predictive value than WHO recommended RDT testing algorithms that do not     include confirmatory testing.   "
119918|NCT01716286|"     The aim of the current study was to investigate the effect of a low fat meal in comparison to     a low fat meal dosed with the fatfree essence of olive oil.   "
119919|NCT01716273|"     How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating     wounds compared with standard treatment?   "
119920|NCT01716260|"     This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for     Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients     with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for     28 days so as to study the efficacy of CQ alone.      This study will assess whether CQ is still effective against P.vivax or whether there are     resistant P.vivax strains in Bhutan.   "
119924|NCT01716208|"     It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have     low levels of complement. Several drugs have been approved by the Food and Drug     Administration (FDA) for use in this cancer. However, these drugs are often used as     combination therapies which means two or more drugs are part of the treatment. Many people,     especially elderly patients, cannot put up with the use of multiple drugs because of the side     effects.      The main purpose of this study is to see if patients respond to therapy with human plasma     (known as fresh frozen plasma or FFP) and ofatumumab. Another purpose of the study is to find     out if this therapy will increase chances of getting rid of leukemia. This study will also     look at the levels of complement in your blood. The levels of complement may allow better     understanding of whether increasing the levels of complement by giving FFP may help control     leukemia.   "
119925|NCT01716195|"     The purpose of this study is to determine whether human papillomavirus (HPV)-positive head     and neck cancer can be treated with a less aggressive regimen of radiation therapy and     chemotherapy (paclitaxel) after initially receiving two cycles of chemotherapy     (carboplatin/paclitaxel).   "
119926|NCT01716182|"     This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a     Multicenter, Randomized, Prospective format. This study compares two spinal fusion     procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF).     Enrollment period will be approximately 12-18 months; each Principal Investigator/Study     Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7     subject visits to the study center from screening through the final follow-up visit.   "
119927|NCT01716169|"     The purpose of this study is to test the effectiveness of Helicoll (a collagen wound     dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis     bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.   "
119928|NCT01716156|"     This study will compare two different durations of treatment with grazoprevir (MK-5172) in     combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible     interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic     hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination     therapy.   "
119929|NCT01716143|"     The purpose of this study is to determine whether left atrium substrate based ablation plus     circumferential is effective in the treatment of persistent and long-standing atrial     fibrillation.   "
119930|NCT01716130|"     To assess the acceptance of the Fluzone Intradermal (ID)vaccine in adults and vaccine     administrators in the United States. Patients completed 2 surveys, one immediately     post-vaccination and one seven days later, that documented demographics and assessed their     injection pain, injection anxiety, speed of injection, overall satisfaction, and preference     for next year's vaccine. Vaccine administrators completed one survey assessing ease of     vaccine preparation and administration, time required to administer, and safety/risk of     needle stick injury for patient and administrator.   "
119931|NCT01716117|"     This clinical research study is designed to determine safety and effectiveness of the Surpass     Flow Diverter (Surpass System), an investigational device developed to treat wide neck, large     or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood     vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left     untreated, the bulge may continue to grow larger and ultimately the vessel may break open     (rupture), resulting in serious bleeding into or around the brain. The information collected     from this study will be used to evaluate how well patients do when treated with the Surpass     System both immediately after treatment of an aneurysm and over a long period of time (5     years).   "
119932|NCT01716104|"     The purpose of this study is:        -  To assess safety of Afalaza drug within 12 months in patients with symptoms of benign          prostatic hyperplasia and risk of progression.        -  To assess efficiency of Afalaza drug within 12 months in patients with symptoms of          benign prostatic hyperplasia and risk of progression.   "
119933|NCT01716091|"     The investigators hypotheised that irrigating the abdominal cavity with saline at the time of     cesarean delivery will increase Gastrointestinal System Disfunction without maternal     infectious morbidity(especially febril morbidity).   "
119934|NCT01716078|"     The purpose of this study is to determine the conducting ability of distal extremity nerves     after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed     at a more proximal location in the upper extremity.   "
119935|NCT01716065|"     The purpose of the study is to determine whether the type of anesthesia during breast cancer     surgery has any impact on the way a patient's immune system functions for a brief period     after surgery. If the investigators find that one type of anesthesia versus the other is more     beneficial to a patient's immune system, then the investigators may use this information to     design a larger study to exam the effect of anesthesia better.   "
119936|NCT01716052|"     The purpose of this study is to determine in a randomized trial whether it is possible to     decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a     scripted, supportive text informing patients about mammography.   "
119937|NCT01716039|"     Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate     interaction in subjects with moderately to severely active ulcerative colitis.   "
119938|NCT01716026|"     The purpose of this protocol is to determine wether the initial protocol in the treatment of     subfoveal choroidal neovascularization associated to High Myopia with bevacizumab     intravitreal injections is more effective when using 3 doses vs using 1 single dose in the     load period   "
119939|NCT01716013|"     To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in     terms of cosmesis (appearance) of the repaired wound when these devices are used for closure     of surgical and traumatic wounds .      To demonstrate safety of BondEase™.   "
119940|NCT01716000|"     This study will compare two investigational techniques for measuring how vaginal gels spread     and coat the vagina. This study will also explore the experiences and opinions of women using     this vaginal gel. We want to understand how the characteristics of a gel, such as a gel's     thickness or consistency, affect how the gel spreads and feels in the body. We hope to use     the information we learn from this study to develop future vaginal gels that could be     combined with medications and used to slow down or stop the spread of sexually transmitted     infections.   "
119944|NCT01715948|"     People with single-sided deafness (SSD) have significant hearing loss in one ear and normal     or near normal hearing in the other ear. Those living with SSD experience several     communication difficulties, particularly when listening to speech in the presence of     background noise. This problem is worse in situations where the noise is on the side of the     good ear and the speech is on the side of the poor ear.      The Bone-anchored hearing device (BAHD) and the Contralateral Routing of Signals (CROS)     hearing aid are two intervention methods designed to improve hearing in people who have     significant hearing loss in one ear only. The BAHD is a surgically implanted device which     also includes an external processor; sounds from the poor ear are transmitted to the good ear     through skull vibrations. The CROS does not involve surgery; instead a hearing aid is fitted     behind each ear, and the sounds on the side of the poor ear are wirelessly transmitted to the     good ear.      The majority of previous studies comparing the BAHD to the CROS have used older CROS models     with basic technology and a wire along the neck to send sounds from the poor ear to the good     ear. There is a lack of studies comparing newer digital wireless CROS hearing aids to the     BAHD. The current research will compare the effect of the BAHD and CROS hearing aid on speech     perception scores when listening to speech in quiet and in noise. The research will also     investigate participants' reported benefits with each device during everyday situations. In     order to compare the BAHD and CROS, individuals who already have been implanted with a BAHD     will be given a trial period with a new wireless digital CROS hearing aid.      The research hypothesis states that the CROS hearing aid will be as equally beneficial or     greater than the BAHD in improving hearing and participant benefit. If the findings support     the hypothesis that the CROS offers just as much benefits as the BAHD, or is an even better     alternative, more individuals with SSD may choose to avoid surgery and decide to receive a     CROS hearing aid instead.   "
119945|NCT01715935|"     Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma      An open-label, exploratory, single-arm, multicenter trial.      Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest     period prior to nephrectomy.      Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients     until disease progression, unacceptable toxicity, withdrawal of patient consent, or other     stopping rules are met.   "
119946|NCT01715922|"     The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association     of:        1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100          mg/kg/j) as induction therapy        2. lumbar punctures to control intracranial pressure      can decrease mortality rate below 35% at 10 weeks.      This is a non-randomized open label pilot study, with standardized management of     cryptococcoses meningitis and follow-up in Burundi and Ivory Coast. A total of 41 patients     will be enrolled.   "
119947|NCT01715909|"     This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the     pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children,     less than (<) 13 years of age, with confirmed influenza infection. Participants will be     randomized to receive either the standard dose or triple dose of oseltamivir orally daily for     a minimum of 5 days and up to 20 days. Infants <1 year of age will be randomized to the     standard dose arm only.   "
119948|NCT01715896|"     The primary objectives of this study is to explore the efficacy of mavrilimumab compared with     golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe     active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional     disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor     (TNF) agents (excluding golimumab) for efficacy or safety reasons.   "
119949|NCT01715883|"     This is a Phase IIA observational nonrandomized pilot investigation to evaluate the safety     and efficacy of Sodium Nitrite administration for the reduction of PGD in patients undergoing     lung transplant. The study will enroll 8 subjects, undergoing lung transplant at the     University of Pittsburgh Medical Center (UPMC).   "
119950|NCT01715870|"     The study population will be selected from the Epidemiological study on the prevalence of     Age related Macular Degeneration in Portugal (Protocol N. CC-01-2009) where retinal     photographic grading (current gold standard for AMD assessment) was performed to confirm AMD     diagnostic. This study provides a population-based sample in which precise and contemporary     information on the frequency of nutritional and lifestyle risk factors will be collected,     enabling to evaluate whether the separate and/or joint effects of these factors, if found     significant, are likely to have a major public health impact in terms of AMD.   "
119951|NCT01715857|"     Until recently, there was a lack of understanding and consensus among Chinese     anesthesiologists how they should practice general anesthesia with volatile anesthetics,     since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch     of the Chinese Medical Association launched the first version of Chinese Consensus of     Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the     practice in China.      The proposed registry is aimed to evaluate the current inhalation practice one year after the     Consensus has been released, and related patient outcome. This registry evaluated sevoflurane     anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24     hours post-operation.   "
119952|NCT01715844|"     In people who develop asthma after the age of 12 and who are also overweigh, there can be an     increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when     compared to normal weight asthmatics. Certain factors are more abundant in the blood of     individuals who are obese. One such factor is derived from the metabolism of an amino acid     found in your diet, which is known as L-arginine (Amino acids are most commonly known as the     building blocks of proteins, the same as the proteins found in food). This factor is called     asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to     the health of subjects with asthma. The balance between L-arginine and ADMA plays an     important role in producing nitric oxide (NO) in the airways. NO is normally produced in the     lung and plays a major role in maintaining airways open and functioning normally. Our     research has shown that in subjects with asthma who are overweight and developed asthma later     in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels. We are     asking participants in this study to take L-citrulline, which is converted to L-arginine by     your body, as a supplement for a period of one week. We anticipate that L-citrulline will     restore NO levels in the airways, by increasing the ratio of L-arginine to ADMA   "
119953|NCT01715831|"     This multicenter, open-label, single-arm extension study will evaluate the long-term safety     of tocilizumab (RoActemra/Actemra) in participants with RA. Participants who have completed     the MA21488 (NCT00810199) core study and the ML21530 (NCT00754572) study and who could     benefit from the study drug, according to the opinion of the investigator, will receive 8     milligrams per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The     anticipated time on study treatment is 104 weeks.   "
119998|NCT01715259|"     The purpose of this study is to determine the pharmacokinetic (how the drug concentrations     change over time) profile of abiraterone acetate 1000 mg when administered as a single dose     in male participants with impaired renal function compared to individuals with normal renal     function.   "
119954|NCT01715818|"     This randomized, double-blind, placebo-controlled, parallel group, multicenter study will     evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable     cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive     either aleglitazar 150 mcg orally daily or matching placebo.   "
119955|NCT01715805|"     The objective of this study is to evaluate the efficacy, safety and tolerability of     cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD   "
119956|NCT01715792|"     This study aims to assess the risk of solid organ transplant (SOT) rejection following     vaccination with Pandemrix™ and/ or seasonal influenza vaccination.   "
119973|NCT01715571|"     The primary objective of this study is to assess the safety, acceptability, and satisfaction     of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary     objective is to demonstrate subjective physiological response (erection, rigidity, orgasm)     after four weeks of frequent device use and the satisfaction of penile erection and sexual     intercourse with partner.   "
119974|NCT01715558|"     The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by     RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes     in bradycardia target population.   "
119957|NCT01715779|"     The objective of this observational study is to characterize long-term (5 years post event)     clinical outcomes in patients who experienced a thromboembolic event (TEE) during     participation in the GSK ENABLE clinical trials.      Patients eligible for the study are patient who experienced a TEE during participation in the     ENABLE trials. Each included patient will be followed for a period of 5 years from the date     of their first TEE. Demographic and clinical characteristics will be collected for the index     date (time of TEE) and every sixth month during the follow-up period, information will be     collected for the outcomes of interests: mortality, new TEE, hepatic decompensation,     evaluation for liver transplant and result of evaluation, and liver transplantation.      All information will collected by medical record review.   "
119958|NCT01715766|"     The purpose of the study is to learn about the causes of different types of pain that can     occur in people who have had an amputation. By gathering information through blood tests,     photographs, a nerve test, and questionnaires, we hope to de-code how each individual's     special characteristics affect the type and amount of pain they experience in their amputated     limb.   "
119959|NCT01715753|"     The purpose of the trial is to assess the effects of weight loss on functional status and     lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight     reduction intervention. Participants will be randomized into one of two study arms: Weight     Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or     Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss     of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of     high quality protein will be achieved three times a day by subjects in this group,     predominantly all from animal sources and 60-70% of animal protein from beef. Subject     criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate     functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)   "
119960|NCT01715740|"     Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at     some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly     affect the quality of life. Some patient with chronic urticaria who had poor response to     antihistamine may need second line medication. In United States, up to 54% chronic urticarial     patient use oral corticosteroid to control. However, long-term use of oral steroids still     needs to consider the impact of its side effects. Therefore, patients may seek for     alternative medicine as an adjuvant therapy.      It is still lack large-scale clinical trials in Traditional Chinese Medicine research of     chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical     trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible     mechanisms.   "
119961|NCT01715727|"     The hypothesis of the study is that the dopaminergic cell death located in the basal ganglia     of the brain in patients with Parkinson's Disease can be detected by diffusion Magnetic     Resonance Imaging, specifically by diffusion kurtosis imaging. The preliminary result was     published in Radiology 2011. The current study proposed to investigate the following issues:        -  validation of diagnostic sensitivity and specificity        -  differential diagnosis capability between PD and PD+ syndrome        -  prognosis capability      In the first year, patients with Parkinson's disease will be recruited from the outpatient     clinics of movement disorders in ChangGung memorial hospital Linkou, Taiwan. The diffusion     parameters in basal ganglia will be compared with a group of healthy controls. In the second     year, patients with progressive supranuclear palsy and patients with multiple system atrophy     will be recruited for assessment of differential diagnosis. The patients with Parkinson's     Disease will return for assessment of disease severity and in the third year, for the outcome     evaluation.   "
119962|NCT01715714|"     Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at     risk for postoperative complications after surgery. The StaRT-CABG trial is the first     large-scale (2,630 patients) that will investigate whether an additional treatment with     statins (lipid-lowering medication) in high doses before CABG surgery can reduce the     incidence of major post-surgery complications including death, myocardial infarction and     stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in     Germany and is expected to provide relevant clinical data on the efficacy of this novel     treatment in order to optimize the care for all patients undergoing CABG.   "
119981|NCT01715467|"     This observational study will prospectively collect data on treatment options,     patient/investigator satisfaction, requirement for retreatment or additional treatment, and     long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle     aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide     additional health economics and utilization data.   "
119999|NCT01715246|"     The primary objective of this clinical study is to show that infants fed a standard starter     infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants     fed a standard starter infant formula without HMOs.   "
120000|NCT01715233|"     To estimate and compare the response rates in patients treated with mDCF based on methylation     status of CHFR.   "
119963|NCT01715701|"     This study is designed to assess:        -  The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to          intercostal nerve blockade performed at the end of surgery on the intensity of          postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as          their primary analgesic modality.        -  The incidence of chronic pain at 6 months following video-assisted thoracic surgery.        -  The impact of preoperative multilevel paravertebral nerve blockade on patients' quality          of life at 6 months following surgery compared to intercostal nerve blockade and to a          control group using PCA alone.      Hypothesis:        1. The basic hypothesis of this study is that preoperative thoracic multilevel          paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the          end of surgery will provide superior postoperative analgesia and lower opioid          consumption compared to PCA alone during the first 24 hours following surgery.        2. Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence          of chronic pain at 6 months following surgery.        3. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal          nerve blockade performed at the end of surgery will shorten the length of stay in the          intermediate intensive care unit and shorten the hospital stay.        4. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal          nerve blockade performed at the end of surgery will reduce postoperative pulmonary          complications.   "
119964|NCT01715688|"     This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with     alkalinized lidocaine on the:        -  incidence of coughing during emergence of general anesthesia        -  time needed for emergence following a desflurane-based anesthesia        -  incidence of sore throat after extubation.      The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with     alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control     group following a desflurane-based anesthesia.   "
119965|NCT01715675|"     Rationale: Plant stanols are well known for their effects on lowering intestinal cholesterol     absorption ultimately resulting in 10-15% reduced serum LDL cholesterol concentrations in     humans. In addition we have also shown that serum triacylglycerol (TG) concentrations may be     lowered in subjects with elevated baseline concentrations. Till now, there is little evidence     for plant stanol effects other than improving lipid profiles. However, we have very recently     found strong indications in ex vivo models using isolated human peripheral mononuclear blood     cells (PBMCs) from healthy volunteers that plant stanols have the capacity to improve immune     function. More into detail, plant stanols shifted the differentiation of naive T-cells into     the Th1 direction by activating a specific receptor present on the Antigen presenting cells     (APCs) and T-cells. This effect might ultimately be helpful in situations in which the     Th1/Th2 cell balance is disturbed into a Th2 over-responsiveness. By activating the Th1     response, the disturbed balance may be restored. This is for example a possibility in the     treatment or prevention of asthma, food allergies or HIV in susceptible subjects. In     addition, very recently (MEC 08-3-051) in a pilot study we also showed these ex vivo Th1     stimulating effects of plant stanols specifically in PBMCs isolated from asthma patients, as     said, a condition characterized by a Th2 dominant immune response.      Objective: The major research objective is to prove that the consumption of plant stanol     ester enriched yogurts can improve immune function in vivo in asthma patients.      Study design: A double-blind randomized placebo-controlled human intervention study in which     90 patients with clinically proven asthma will participate: 45 in the intervention group     receiving plant stanol yoghurt and 45 in the control group receiving a control yoghurt     without added plant stanols. At the end of the run-in period as well as at the end of the     experimental period blood will be sampled to isolate PBMCs. These cells are used to evaluate     effects on cytokine production, phagocytic capacity of neutrophils, and the activity of NK     cells. In addition, the golden standard to show improvements in immune function is by showing     an elevated Immunoglobulin response to a vaccine. Therefore, during the experimental period     all subjects receive a vaccination against Hepatitis A Virus. After 1, 2, 3, and 4 weeks     blood will be sampled to monitor specific immunoglobulin titers to HAV.      Study population: 90 people with clinically proven asthma, who are not carrier of hepatitis     A, B or C and have not been vaccinated against hepatitis A in the past. Also, these     participants do not have any other immune-related pathology Main study parameters/endpoints:     primary: Specific anti-HAV antibody titers after vaccination; secondary: Phagocytic capacity     of neutrophils; NK-cell activity; Th1 and Th2 cytokine production profiles by PHA stimulated     PMBCs.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: During the study, 9 blood samples (each 20 or 50 mL) will be taken. Total time     investment for the subjects will be 160 min. Occasionally, a heamatoma or bruise can occur     during venipuncture. After the vaccination a heamatoma or a sore arm can occur. These side     effects should disappear within 4-5 days. Other common side effects related to the     vaccination are headache, loss of appetite, and fatigue, which usually will disappear within     24 hours.      The results of this study will show whether consumption of plant stanol enriched yogurts is     able to restore the disturbed th1/Th2 balance in asthma patients. Ultimately, this is     expected to reduce asthmatic exacerbations, as the Th2 dominant immune response seems causal     to asthmatic symptoms, however these clinical improvements are not verified in this     relatively short term intervention study.   "
119975|NCT01715545|"     The purpose of this study is to explore a method to identify the viability of day-3 poor     quality embryos   "
119966|NCT01715662|"     This is a pilot randomized controlled trial to assess the feasibility of a home-based     Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a     lower limb amputation. Twenty four individuals with a unilateral below-knee or above-knee     amputation will be randomly allocated to Wii.n.Walk or control arm. The Wii.n.Walk arm will     receive aerobics, weight-shifting, balance games and exercises using the Wii Fit gaming     technology. The control arm will receive cognitive computer games and exercises using Wii Big     Brain Academy Degree program. Both groups will receive the intervention for 40-minute     sessions, 3x/week for 4 weeks. The interventions will be conducted in combinations of     in-clinic group (n=3) training and individualized in-home training. Outcome measurements will     be completed by a blinded evaluator at baseline, end of treatment, and 3 weeks after the end     of treatment.      Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical     hypothesis is that participants in the Wii.n.Walk intervention group will experience an     improvement in walking capacity compared to the control group. The secondary clinical     hypothesis is that participants in the Wii.n.Walk group will experience an improvement in     balance confidence, physical activity, number of steps taken per day, walking while talking,     lower limb functioning, and locomotor capabilities.   "
119967|NCT01715649|"     Telehealth remote patient monitoring is a means of using communications technology - such as     telephones, computers, and the Internet - to connect patients remotely with their healthcare     team from their homes. The investigators hope to learn more about improving healthy behaviors     and blood glucose among persons with diabetes using telehealth remote patient monitoring     technology to connect directly with nurse care coordinators.      The purpose of this study is to evaluate a process for improving blood glucose and healthy     behaviors among people with type 2 diabetes using telehealth remote patient monitoring     technology with nurse care coordinators. Some of the people in this study will work with a     nurse care coordinator who will review your blood glucose weekly and call you at home every     month for 3 months, while some of the people in this study will simply receive their normal     care. At the end of the study, every participant will be asked questions about how they feel     about their health care.   "
119968|NCT01715636|"     This study aims to describe the safety, tolerability and adherence to the coformulated     anti-HIV drug tenofovir-emtricitabine-rilpivirine (eviplera) when given to men who have sex     with men (MSM) following an actual or potential sexual exposure to HIV. This biomedical     intervention is known as nonoccupational post-exposure prophylaxis (NPEP). Patients receive     NPEP if they meet the criteria outlined in the 2007 National Australian NPEP Guidelines.     Three or two anti-HIV drugs are administered for 28-days depending on the severity of the the     assessed HIV acquisition risk. In this study eviplera would constitute 3-drug NPEP.     Tenofovir-emtricitabine (truvada) a component of eviplera has been used in NPEP at SVH since     2006.      This is a multi site, prospective, open-label, non-randomised trial. Participants will be MSM     who present at the various recruitment sites requesting NPEP. Initially, 50 eligible     participants will be assigned to receive eviplera 25mg once daily taken with food for 28-days     according to established Australian guidelines for the use of 3-drug NPEP. There will be 7     visits over a 12-week period. Follow-up post NPEP is for 8 weeks. If an interim analysis     demonstrates acceptable safety, it is proposed to seek ethics approval to increase the     samples size to 100 patients to gain more accurate information on regimen completion rate and     on-drug adherence.      The primary study objectives are:        1. To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF        2. To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF        3. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using          FTC-RPV-TDF   "
119982|NCT01714401|"     Patients of the ICU's often require bronchodialtatory treatment due to bronchospazm caused by     conditions like : ARDS, COPD or asthma. The β2 adreneregic drugs are one of the most commonly     used for this purpose. However it is known that they may cause tachycardia and may have     substantial proarrhythmic effect. The investigators' aim is to estimate the influence of     nebulized bronchodilatatory drugs on selected electrophysiological parameters, whose changes     are generally recognized as potentially increasing the risk of ventricular and     supraventricular arrhythmias. Two drugs will be compared - salbutamol given in two doses and     ipratropium bromide   "
119969|NCT01715623|"     The investigators previously showed that both antibody class switching (from IgM to IgG, IgA     or IgE) and antibody secretion are controlled by a polymorphic 3' regulatory region (3'RR)     of the immunoglobulin heavy chain (IgH) locus. Alleles of the 3'RR have shown influences on     the severity and progression of IgA nephropathy (IgAN) (with an over-representation of the B     allele among patients with severe kidney IgA deposits). Allele B also constitutes a risk     factor for celiac disease, herpetiform dermatitis, psoriasis and rheumatoid arthritis. Since     the 3'RR now appears as a crucial regulator of Ig production, we wish to check whether its     genetic polymorphism might influence not only the occurrence of immunopathologic processes     involving class-switched antibody deregulated production but also the severity of such     diseases or the time course of their progression. We wish to focus on two conditions     involving class-switched antibodies: on one hand the severe forms of IgE hypersensitivities,     and on the other hand a disease involving pathogenic IgA and for which the prognosis is     currently very difficult to predict at the onset of the disease: Henoch-Schonlein purpura     (HSP).      Regarding hypersensitivities, the diversity of their clinical manifestations prompt us to     focus on homogeneous groups of patients and we thus wish to concentrate on two groups of     patients who are frequently referred to the hospital: severe allergies to Hymenoptera venoms     and severe food allergies related to peanut allergens sensitization. These groups will be     built by considering multiple clinical criteria (clinical history, severity of the     manifestations, positive skin tests, and positive oral provocation tests for peanut     allergens…) and biological criteria authenticating the mechanisms of the disease (high     specific serum IgE, demonstration of specific basophil activation by the allergen…).      In parallel to the study in patients, we will include a large cohort of healthy controls (400     individuals), in order to be able to decipher whether correlations can be seen between:        -  IgH 3'RR genotypes        -  The serum accumulation of the various Ig classes, including IgG subclasses, IgA (which          are sometimes depicted as protective, sometimes as tolerogenic and anti-inflammatory)          and IgE (highly pro-inflammatory and responsible for hypersensitivities)        -  IgG allotypes (with 6 frequent IgG haplotypes known in human and previously reported as          correlated with varying levels of IgG and IgE production in normal individuals).   "
119970|NCT01715610|"     This study aims to look at the necessity for prescribing antibiotics post-drainage of     peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with     two arms - patients receiving placebo versus those receiving a seven day course of oral     Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is     resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will     be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be     phoned after 7 days to assess if their symptoms have resolved via an over the phone     questionnaire. Anaerobic and aerobic cultures will be obtained.   "
119971|NCT01715597|"     The investigators want to know whether the intravenous ascorbic acid would reduce the blood     loss during laparoscopic myoma surgery. The investigators randomized patients into     intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.   "
119972|NCT01715584|"     It is controversial whether or not patients whose Renin Angiotensin System is blocked for the     treatment of hypertension suffer increased risk when undergoing surgery and anaesthesia.      The investigators wish to test the hypothesis: Blockade of the Renin Angiotensin System     causes altered dose response under general anaesthesia in a dose dependant manner. The     investigators wish to look for altered responses across the usual anaesthetic dosing range as     measured by blood pressure and heart responses.   "
119976|NCT01715532|"     Primary Outcome Measures:      - To compare the progression free survival(PFS) in patients with unresectable hepatocellular     carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without     Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3     family.      Secondary Outcome Measures:      - To compare the overall survival(OS), objective response rate(ORR), and side effects of     treating HCC with TACE plus Huachansu or TACE alone.      Exploratory Outcome Measures:      - To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3     family.   "
119977|NCT01715519|"     The purpose of this study is to determine whether vilazodone is effective in the treatmen of     Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.   "
119978|NCT01715506|"     This is a single-blinded controlled cluster-randomized intervention trial recruiting staff     from 24 NHs in three counties in the region of Western Norway, randomly selected from the     total NH population in the region. A cluster is defined as a working ward of a larger NH,     without shared facilities or staff. The 24 NHs are randomized into two groups, for     intervention (12) and control (12). One department in each is selected for intervention and     data collection will take place also in one department in each of the NHs in the control     group. Hence the analyzed units (clusters) are NH departments. The educational intervention     (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly     guidance for six months. A seven-month educational intervention will be performed, and due to     ethical issues the control group will receive the same intervention after the second     follow-up. Effects will be measured on resident and care staff level at baseline before     randomization, after the intervention (7 months) and at follow-up (7 months later) of the     intervention group.   "
119979|NCT01715493|"     The aim of this study was to assess the effectiveness for small airway inflammation of 4     weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.   "
119980|NCT01715480|"     The overall purpose of this study is to obtain a better understanding of the biological     response of red blood cells to sulforaphane contained in fresh broccoli sprouts that have     been put through a blending process. This study will use commercially available fresh     broccoli sprouts certified by Brassica Protection Products LLC (BroccoSprouts®). This product     can also be purchased at some local grocery stores in the produce section. It is believed     that NRF2, a transcription factor encoded by the NFE2L2 gene, plays a role in the regulation     of defense against oxidative stress. The detrimental accelerated breakdown of sickle cell     disease (SCD) red blood cells (SS RBC) is partially due to reduced anti-oxidative capacity.     Previous analysis of SS RBC microRNAs revealed that a reduced level of NRF2, the master     regulator of anti-oxidative stress capacity, contributes to reduced resistance to oxidative     stress and increased hemolysis; NRF2 also induces fetal hemoglobin (HbF), which is known to     prevent SS RBC sickling.      First, erythroid progenitors from normal and SCD subjects will be tested ex-vivo to find out     how sulforaphane, a natural NRF2 activator, affects the oxidative stress capacity, HbF     expression, and microRNA expression of red cells.      Second, a pilot clinical trial will be conducted to determine the safety and physiological     effects of 3 weeks of daily consumption of broccoli sprout homogenate in a cohort of Hb     SS/SB0 thalassemia adult SCD patients. During this study, subjects RBCs will be assayed for     changes in anti-oxidative stress capacity and microRNA composition in mature SCD red blood     cells.   "
119997|NCT01715272|"     This study is designed to assess the difference between the performance of a new enema     (TF037) against Fleet enema in distal bowel cleansing.   "
119983|NCT01714388|"     Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general     anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients.     Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion     regimen is allowed. Pharmacokinetic/pharmacodynamic parameters of RMFNT results in rapid     onset and offset of clinical effect, which makes this drug almost ideal in many situations.     Unfortunately, its vagomimetic influence on cardiac activity may result in decrease of heart     rate. It may be hypothesized that patients with parasympathetic predominance may be prone to     more intense parasympathomimetic effect of this opioid. An optimal method for assessment of     autonomic nervous system activity and assessment of influence of RMFNT on that activity is     Heart Rate Variability (HRV) analysis. Parasympathetic predominance is expressed as high     frequency (HF) power and HF/(LF+HF) (LF-low frequency) ratio in frequency domain and Root     Mean Square of the Successive Difference (RMSSD), the number of pairs of successive NNs that     differ by more than 50 ms (NN50), the proportion of NN50 divided by total number of NNs     (pNN50) in time domain. The aim of this study is to verify the hypothesis that patients with     predominance of parasympathetic activity are more subject to vagomimetic effect of RMFNT. HRV     based on 5 minutes electrocardiogram (ECG) recorded before and after bolus dose of RMFNT will     be analyzed. The occurrence of heart rate decrease will be than compared between patients     with sympathetic and parasympathetic predominance measured prior to drug injection.   "
119984|NCT01715441|"     The aim of this multicenter randomized phase II trial is to determine the efficacy of     sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib     monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure     of all active drugs known to be effective.   "
119985|NCT01715428|"     Incretin-based therapies have shown significant effects beyond those on glucose metabolism.     We aim in the present study to evaluate the effects of liraglutide on several     cardio-metabolic risk markers.   "
119988|NCT01715389|"     This pilot intervention study will test the feasibility and acceptability and explore the     outcomes of a primary care-based shared decision making (SDM) electronic medical record     (EMR)-based portal that provides education, elicits and tracks patients/families' treatment     concerns and goals, assesses symptoms and asthma control over time, and provides decision     support to clinicians and families.   "
119989|NCT01715376|"     Compared with standardized western medical drug therapy, this study is mainly about whether     the combination of standardized western medical drug therapy and Chinese medical continued     treatment, can further decrease the rate of cardiovascular events for stable angina patients     and change the condition of angina.   "
119990|NCT01715363|"     The purpose of this study is to analyze the clinical tolerance of immediate preoperative     chemotherapy in terms of toxicity and perioperative morbidity and mortality   "
119991|NCT01715350|"     The investigators intend to perform exploratory evaluation of the treatment effectiveness and     safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to     moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose     with placebo control for the efficacy and safety to explore the clinically optimal dose of     PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.   "
119992|NCT01715337|"     Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in     patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a     potential change in muscle fibre composition and in the amount of capillaries in quadriceps     muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes     standardised exercise training, e.g. cycling and strength training for major muscle groups.   "
119993|NCT01715324|"     In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually     taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols     are constantly under review in order to improve the recruitment of the follicles, which     contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate     aim of increasing the live birth rate.      The addition of growth hormone, which is a biological hormone that can be synthetically     produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been     suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth     hormone has been shown, in animal and human studies, to be important in the recruitment of     follicles.However, to date, only a limited number of clinical studies have been performed in     order to assess whether the addition of growth hormone can improve the probability of     pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total     number of patients analysed in these studies was small it has not been possible to determine     whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a     woman is given growth hormone therapy as a supplement during her treatment.      This goal of this study is to determine the effectiveness of using growth hormone therapy as     a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization     protocol.   "
119994|NCT01715311|"     This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication     only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have     not received maintenance COPD medication for at least 12 months prior to entry (described     hereafter as maintenance naïve, see inclusion criteria).   "
119995|NCT01715298|"     The study serves to determine whether the treatment of patients with stable, symptomatic     Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is     efficient and safe. The efficacy and safety of the drug will be tested against a placebo     treatment. The primary criterion to assess efficacy will be the difference between the serial     lung function measurements of patients who have been treated for 12 weeks with NVA237 versus     those that have received placebo treatment for 12 weeks. A serial lung function measurement     (FEV1 testing) will be conducted and the area under the curve will be the measure for the     ability to breathe.   "
119996|NCT01715285|"     The purpose of this study is to determine if newly diagnosed (within previous 3 months)     participants with metastatic (spread of cancer cells from one part of the body to another )     hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from     the addition of abiraterone acetate and low-dose prednisone to androgen deprivation therapy     (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).   "
120023|NCT01714934|"     The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult     to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a     proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were     described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar     lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence     of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for     gastric microaspirations in the pathogenesis of the disease.   "
120024|NCT01714921|"     Examination of application and efficacy of Smart Shock algorithm in ICD patients   "
120025|NCT01714908|"     Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in     unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation     of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin     with concurrent radiotherapy.   "
133645|NCT01535651|"     The investigators are exploring the use of short message service (text) messaging by cell     phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy     prevention program.   "
120001|NCT01715220|"     ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from     suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate     its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving acute     pain of suspected biliary tract origin.      Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during ERCP,     (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal     experience and small case reports. Nitroglycerin effect is a result of the nitric oxide     component of the medication which acts as a smooth muscle relaxant in vascular, bronchial,     esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The     typical dose of nitroglycerin is 0.4 mg given sublingually in pill form or, more recently, in     a metered spray form. In a case series reported by Hassel (1993), positive response times     ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual     nitroglycerin is most commonly used for treatment of chest pain related to insufficient     cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms.     Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment     blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This     study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for the initial     treatment of acute pain from suspected symptomatic cholelithiasis   "
120002|NCT01715207|"     Marfan syndrome (MFS) is an inherited disorder of connective tissue with morbidity and     mortality from aortic dilatation and dissection. The current standard of care is beta-blocker     (BB) treatment and therapeutic target is heart rate. The degree of aortic dilatation and     response to BB vary in adults with MFS. However, aortic stiffness is often present, and can     be a predictor of aortic dilatation and cardiovascular complications. Aortic stiffness is a     logical therapeutic target in adults with MFS.      Transforming growth factor beta(TGF-beta) mediates disease pathogenesis in MFS and     contributes to aortic stiffness. Cross-talk between TGF-beta system and renin-angiotensin     system (RAS) has been demonstrated. The angiotensin receptor blocker (ARB), losartan,     inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. In a     small cohort study, the use of ARB therapy (losartan or irbesartan) significantly slowed the     rate of progressive aortic dilatation in patients with MFS, after BB therapy had failed to     prevent aortic root dilatation. In another study, angiotensin converting enzyme inhibitor,     perindopril, reduced both aortic stiffness and aortic root diameter in patients with MFS     taking standard BB therapy. Renin inhibitor, aliskiren, has not been studied to reduce aortic     stiffness and attenuate aortic dilatation in patients with MFS.      This trial is a randomized, open-label trial of 32 patients with Marfan syndrome, treated     with 6 months of aliskiren vs. negative controls in patients with MFS under atenolol     treatment. MRI for aortic pulsed wave velocity (PWV) and distensibility, measurements of     central BP (CBP) and augmentation index (AIx) will be performed at the beginning and end of     treatment. A blood drawn for serum markers of TGF-beta, extracellular matrix turnover and     inflammation will also be performed at 0 and 6 months. We plan to determine whether aliskiren     decreases aortic stiffness significantly more than negative controls in patients with MFS     under atenolol treatment.   "
120003|NCT01715194|"     We hypothesize that the use of telemedicine combined with support interventions by short     messages, telephone calls and ambulatory visits to control CPAP treatment during the first     month improves adherence and reduces unresolved side effects of therapy.      The primary objective of an OSAS treatment program is to successfully implement indicated     CPAP in the highest possible proportion of patients in order to lower the proportion of     untreated OSAS in the population. On an individual basis, it has been shown that a longer     duration of CPAP use is associated with better outcomes in terms of daytime functioning and     in the control of metabolic and blood pressure effects of CPAP. For our study, we have     therefore decided to use 2 co-primary endpoints, taking into account both aspects of     adherence mentioned. Cardiovascular complications are a major concern in OSAS patients.     Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk.     We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive     impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of     treatment.   "
120004|NCT01715181|"     Older adults with Alzheimer's disease and other forms of dementia frequently develop     challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological     strategies to manage these symptoms such as music, exercise, and participating in pleasant     social events have been demonstrated to be safe and effective strategies to reduce these     behavioral symptoms. Our project, Volunteers Adding Life in Dementia (VALID), will design and     implement a volunteer-led program to reduce behavioral symptoms and improve the quality of     life of older adults with dementia who are residing in long-term care facilities.   "
120005|NCT01715168|"     The purpose of this study is to find the answers to the following research question(s):      1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same     way in the body as the approved drug?      ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to     prove. All people who participate in this study will receive the research study medication     (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).      The study drug being tested in this study works the same as the FDA (government) approved     drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being     delivered (given to the patient).   "
120006|NCT01715155|"     The purpose of this study is to evaluate the incidence rate of progression of disease, to     describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in     the clinical practice in Bulgaria.   "
122217|NCT01686230|"     This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic     stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and     waiting-list. And to confirm the specificity of acupoints on meridian.   "
120007|NCT01715142|"     Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease with conventional     treatments having little impact on disease course. Novel approaches are urgently needed to     address inherent resistance to the current therapies and to identify new drugs or     combinations that will have a high chance of success in pancreatic cancer patients. This     proof-of-concept trial is studying the dynamic tumor response after the administration of a     short course of gemcitabine and nab-paclitaxel (Abraxane) (a) during a window interval (4     weeks= 1 cycle) before surgery in resectable pancreatic cancer (cohort 1 = 21 patients) and     (b) during at least 8 weeks (2 cycles) in locally advanced or metastatic pancreatic cancer     (cohort 2 = 10 patients).   "
120008|NCT01715129|"     Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when     administered by subcutaneous route.   "
120009|NCT01715116|"     The purpose of this study is to determine whether Enhanced device programming to reduce     therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and     inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator     (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs     and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.   "
134388|NCT01525810|"     The primary purpose of this study is to determine whether the hepatitis C virus continues to     remain unable to be detected in subjects who were previously treated with BMS-914143 and     achieved sustained virologic response   "
120010|NCT01715103|"     Current knowledge on mucosa, especially genitals in women, however, remain inadequate,     especially regarding defense mechanisms and possibilities for a vaccine to induce an active     immune response at mucosal front door of the most pathogens. Induction of mucosal immune     response has emerged as a research priority research prophylactic vaccine.The development of     strategies to prevent sexual transmission of HIV-1 depends in part on an understanding of     specific and innate immune mechanisms involved in this transmission.      MUCOVAC is a feasibility study of the immunological and transcriptomic analysis of     cervicovaginal samples of women infected or not infected with HIV-1. We also assess tolerance     samples taken by cytobrush and cervicovaginal washings, efficiency and reproducibility of the     sample by cytobrush and cervicovaginal lavage for transcriptomic analysis, measurement of     cytokines by Luminex technology, quantification of IgG and IgA. In blood we will determine     the phenotype of B cells and Tfh cell frequency (T follicular helper) and quantification of     serum immunoglobulins and will perform a transcriptomic analysis of blood cells. Finally we     will make correlations with the observed responses at the genital mucosa.      This pathophysiological exploratory study will be performed in 20 women infected with HIV-1     and 20 healthy women recruited from two centers in France and will include a screening visit     and two visits M0 and M1 during which mucous and blood samples will be performed.      The results of the study will capitalize skills in biology mucosa, using powerful tools to     assess mucosal immunological parameters.   "
120011|NCT01715090|"     The main objective of the study is to determine whether an intensive web-based titration     system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective     in improving glycaemic control in patients with diabetes mellitus type 2 using a basal     insulin, compared to standard care.   "
120012|NCT01715077|"     Participants will be taking 3 mg/kg ipilimumab intravenously over a 90-minute period every 3     weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for     functional characteristics.   "
120013|NCT01715064|"     In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third     leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with     feelings of anxiety and depression associated with the disease and associated treatments.     Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this     population, but the impact of single bouts of exercise and related psychological or     neurological changes have never been studied. The primary objective of the proposed study is     to examine the effect of an acute bout of exercise on neurophysiological and psychological     indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa.     Participants will be randomly assigned to the intervention (60 min exercise) or control (60     min of television) and will undergo a brief neurological test (cortical silent period) and     psychological questionnaires before and after their group assignment.   "
120014|NCT01715051|"     The primary objective of this study is to collect pilot data on the efficacy of D-serine,     relative to placebo, as a cocaine dependence treatment. Secondary objectives include     evaluating D-serine, relative to placebo, on: 1. safety in treating cocaine-dependent adults     and 2. tolerability.   "
120015|NCT01715038|"     The program effectiveness study aims to assess the effect of a lipid-based nutrition     supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for     improving maternal nutritional status during pregnancy and lactation (LNS only), and     preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.   "
120016|NCT01715025|"     Women with measured menstrual bleeding >80ml per cycle and no contraindications to combined     oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral     contraceptive for 3 cycles during which they will collect all menstrual blood and send all     used sanitary protection to the laboratory at the University of Sydney for estimation of     blood loss by the alkaline haematin method.      Hypothesis:      An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling     HMB in the majority of women without structural pelvic pathology.      Main outcome:      The primary efficacy end-point will be the proportion of women with a reduction of menstrual     blood loss ≥ 50% from baseline.   "
120017|NCT01715012|"     This study is a randomized, double blind, placebo controlled trial at a single site. The     primary objective is to evaluate the safety of ACCS in diabetic subjects with deep burns. The     secondary objectives of this study are to (1) evaluate efficacy of ACCS in healing burns and     (2) evaluate whether treatment with ACCS results in less scarring, in subjects with diabetes     separately comparing healing of the skin graft and the skin graft donor site using ACCS plus     a burn dressing versus placebo and a burn dressing.   "
120116|NCT01713686|"     This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera®     treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following     treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at     each follow-up visit.   "
120018|NCT01714999|"     Following a recent publication by the authors [1], there is no standardized treatment regime     for the treatment of lacerations of the olecranon or prepatellar bursa, although primary     bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland.     The aim of this study is to prospectively follow patients who suffered from an acute     traumatic laceration of the OB or PB treated, according to the local standards, either by     bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).      [1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and     Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)   "
120019|NCT01714986|"     The investigators want to try the psycho educational method The Affect School with Script     Analysis and the physiotherapeutic mind-body therapy Basal Body Awareness Therapy in     patients with diabetes, high HbA1c and psychological symptoms, in order to improve     psychological health- with the primary outcome reduced depression. Secondary outcomes are     improved improved glycemic control and self-image, and reduced alexithymia and anxiety.   "
120020|NCT01714973|"     The objective of this study is to evaluate the safety and efficacy of ACCS in treating     radiation burns of the skin in patients undergoing treatments for breast cancer and to     compare ACCS treated burns with those treated with saline placebo controls.   "
120021|NCT01714960|"     -  To assess the safety and tolerability of repeat dose topical administration of MRZ-99030          Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma          subjects (stage 2).        -  To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its          metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030          Ophthalmic Solution.   "
120026|NCT01714895|"     Achieving near-normoglycaemia has been established as the main objective for most patients     with diabetes. However, it is well known that intensification of treatment is associated with     an increase in the frequency of hypoglycemia, especially in the context of insulin therapy.     The burden of hypoglycemia in terms of psychological implications, morbidity and even     mortality, explains why it has been defined as the main limiting factor to achievement of     good metabolic control.      Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in     hypoglycemia detection/prevention, allowing theoretically for safer intensification of     therapy in diabetic patients. However, accuracy of CGM devices, especially in the     hypoglycemic range, raises some concerns. In fact, commercially available CGM devices     estimate plasma glucose from measurements in the interstitial fluid and not in plasma.     However, the relationship between plasma and interstitial glucose is not fully understood,     especially under dynamic conditions, and this may explain the poor CGM performance during     rapid changes in blood glucose and hypoglycemia.      In this project, the relationship between plasma and interstitial glucose will be evaluated     under conditions of normal glucose concentrations and hypoglycemia. Experiments will be     performed to assess the role, if any, of different plasma insulin concentrations on the     accuracy of CGM.      All the information obtained may be relevant to the improvement of the ability of CGM devices     to detect hypoglycemia and hypoglycemic risk.   "
120027|NCT01714882|"     The investigators are trying to determine stress management strategies in couples undergoing     In Vitro Fertilization (IVF).   "
120028|NCT01714869|"     The purpose of this study is to find out how effective and feasible an 8-week course of     Swedish massage is, for reducing pain and increasing function in adults who are VA healthcare     users, with osteoarthritis (OA) of the knee.   "
120029|NCT01714856|"     Study subjects were screened and enrolled for the study. Subjects were housed in the clinical     facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each     period. After maintaining at least 10 hours of overnight fast Test or Reference product was     administered orally (as per the randomization schedule) to each subject with about 240 mL of     water at ambient temperature in each period by trained study personnel after consuming the     whole standardized high fat non-veg breakfast.      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were     collected at 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50,     11.00, 11.50, 12.00, 12.50, 13.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study     period with a washout period of 7 days between the dosing of two periods. Subjects were     continuously monitored for well being i.e., blood pressure, radial pulse and oral temperature     before check-in, prior to drug administration and at regular intervals post dose in each     period. The concentration of Ropinirole in plasma samples obtained from study subjects was     determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were     performed on obtained drug concentration data, using appropriate software.   "
120030|NCT01714843|"     This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456     in patients with constipation-predominant irritable bowel syndrome.   "
120031|NCT01714830|"     Chronic pelvic pain (CPP) can affect both sexes and lasts at least for 3 months. CPP in women     could be due to endometrioses, ovarian cyst, colitis, etc, making the correct diagnosis     important (1-3). The most prevalent reason for CPP in men is non-bacterial chronic     prostatitis and in many cases they are considered equivalent to each other (4).      Chronic non-bacterial prostatitis is associated with pain in pelvic region and could be     associated with other symptoms such as dysuria, myalgia, arthralgia, chronic fatigue, burning     sensation in the urethra, abdominal, urine frequency, and pain after ejaculation (4-6).     Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is devided into two groups: III     A Type (inflammatory) and III B (Non-inflammatory). The difference between the two groups is     the presence of leukocytes in prostatic secretions after prostate massage, urine and semen     (7,8).      In general population, the prevalence of chronic pelvic pain syndrome is about 0.5 percent     because many patients do not consider their symptoms as disease, while 6.3% of people may     show symptoms (9-11).      One of the most important challenges in the treatment of chronic prostatitis / chronic pelvic     pain syndrome, is that its etiology is obscure and it is known as a multi-factorial syndrome.     The proposed explanations are infection, psychological reasons, autoimmunity and     neuro-myospasm. Hypotheses about endothelial cells defect and cardio vascular disease have     also been proposed, upon which the new therapies have been based.      In duplex mapping study of prostatic vessels in two groups of healthy and chronic     non-bacterial prostatitis people, it was shown that there was a significant reduction in     systolic flow in prostatic arteries in people who had chronic non-bacterial prostatitis, and     there was a direct association between pain and blood flow intensity, suggesting chronic     ischemia as a possible cause for pain (13). Pain in prostate without significant infection is     the hallmark of chronic prostatitis / chronic pelvic pain syndrome (5). In physical exam,     prostate or pelvic tenderness may be observed in half of the patients.      The diagnosis of chronic prostatitis / chronic pelvic pain syndrome is challenging. No     specific lab test exists for its detection. Prostate specific antigen (PSA) level, which is     typically increased in acute infection, is usually normal in this condition. The diagnostic     approach in these patients is based on ruling out other curable causes such as benign     prostatic hyperplasia or bladder cancer (14-20).      NIH Chronic Prostatitis Symptom Index (NIH-CPSI) is used to evaluate symptom severity and     response to treatment in these patients. A reduction of 4-6 points in the score is considered     significant response to the treatment (21).      There is no first line treatment for patients of chronic pelvic pain syndrome. The use of     anti-bacterial, alpha-blockers or anti-inflammatory drug is logical. However, if the patient     does not respond, further administration is not helpful. In non-responders, combination of     drugs or other non-medical methods should be considered (23-26).      As discussed earlier, blood flow reduction, ischemia and disorders in endothelium of vessels     may cause pain in these patients and methods to improve blow flow may help(13,27). One of     these methods is extracorporeal shockwave therapy (ESWT) which is typically used for     tendonitis, acceleration in bone reunion and wound healing, improvement in muscle movements     through a reduction in passive muscular tonus, increasing muscular range of motion after     cerebrovascular accident (CVA), treatment of Peyronie's disease and erectile dysfunction     (28-30).      Shoskes et al compared 24 chronic prostatitis patients with 11 controls in terms of vascular     stiffness, indexes of increased blood flow, vasodilation and reactive vascular hyperemia,     using Endo-PAT ® 2000-Machine. They showed that endothelial disorder and stiffness along with     the risk of cardiovascular disorders are increased in CP/CPPS (31).      The use of ESWT for the treatment of CP/CPPS has been evaluated in a few studies. In a     double-blind randomized control trial, Zimmermann et al placed 60 patients with chronic     pelvic pain syndrome from chronic non-bacterial prostatitis into two groups and treated one     of them in 4 sessions with a frequency of 3000 per session. The treatment group showed     superior results in terms of symptom improvement(32).      In another study, Zimmermann et al followed 34 patients with chronic pelvic pain syndrome,     after one, four and twelve weeks post ESWT in terms of quality of life and pain reduction.     They showed that this method is useful and without any complications (33).      Considering the promising results of the cited articles along with the paucity of data in     this regard we decided to perform a double-blind sham-controlled study to evaluate the     effectiveness of ESWT in CP/CPPS.   "
120032|NCT01714817|"     The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when     used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)   "
120033|NCT01714804|"     The objective of this study is to prospectively evaluate the performance of Integra Accell     Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a     retrospective comparison to a historical patient cohort.   "
120034|NCT01714791|"     The purpose of this study is to determine the short and long term effects of osteopathic     treatment on pulmonary function, pain and quality of life in patients after coronary artery     bypass graft (CABG) surgery. The study is a randomized controlled trial.   "
120057|NCT01714492|"     Utilize previously developed mathematical model to determine in vivo knee mechanics     (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior     Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several     hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA     will experience polyethylene bearing rotation at 10 years post-operative, similar to their     previous evaluations at six months, two years and five years.   "
120262|NCT01711775|"     This single-center, non-randomized, open-label study will assess the pharmacokinetics of     aleglitazar after administration of single and multiple oral doses in healthy Chinese     volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated     oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening     and a 2-week follow-up, is up to 8 weeks.   "
120035|NCT01714778|"     Electronic cigarettes or e-cigarettes (EC) may have a potential public health benefit as a     safer alternative to smoking and possibly also as an aid in tobacco dependence treatment.     However, there are concerns about their safety and whether they can deliver nicotine     consistently and in doses necessary for such effects.      To be able to consider the safety of ECs and their potential in harm reduction, data are     needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional     cigarettes, users of EC, and people who use both products at the same time.      To accurately assess EC nicotine delivery, data are needed from people who use them     regularly, as there is some evidence of higher and faster nicotine absorption in experienced     users compared with naïve users who try them once in an artificial laboratory setting.      This study will provide information on both of these issues. Forty smokers will be given EC     to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of     acrolein and nicotine will be measured before and after 4 weeks of EC use.   "
120036|NCT01714765|"     When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This     is very difficult to treat and almost all patients will die of their disease within 3 years.      Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal     (kidney) cancer. It targets a growth factor known as VEGF which is important in treating     renal cancer. Although the results with this drug are impressive, patients develop resistance     to the drug, relapse and die of renal cancer. It is currently standard practice is to treat     patients with everolimus when resistance to sunitinib occurs; this is associated with clear     clinical benefit. However the median time to progression with everolimus is 4.9 months in     previously treated patients, therefore further improvement in treating patients is required.     The optimal way of achieving this is to increase the efficacy of everolimus by adding agents     which directly target the cause of resistance to sunitinib.      Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such     as activation of downstream signalling molecules, cell proliferation and survival. Combining     dovitinib and everolimus is very attractive.      This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib     and everolimus in clear call renal cancer, which can then be taken into a randomised phase II     study.      A maximum of 30 patients will be recruited into this multi centre national trial.      Expansion Cohort:      The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and     Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing a     DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib 300mg),     where 2 patients experienced a DLT.      A total of 7 assessable patients will be recruited during the expansion phase at the MTD     (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability,     efficacy, PK and biological end points.      Assessable patients for the expansion cohort are defined as being on the study for a minimum     of 6 weeks. Any patients enrolled who are not assessable will be replaced.   "
120073|NCT01714245|"     The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser     formulated with surfactants and preserved with sodium hypochlorite, is effective at     decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or     eczema.   "
120037|NCT01714752|"     Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health     issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been     shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures     elevated only at exercise (normal at rest).      Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as     a memory of chronic elevation of filling pressures. We believe that it is possible to     improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure     (LVEDP).   "
120038|NCT01714739|"     To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab     (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting     toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to     assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab     (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid     tumors.   "
120039|NCT01714726|"     The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to     placebo. Investigational product will be administered as intravenous infusion in double-blind     period, and as a subcutaneous injection in open-label period   "
120040|NCT01714713|"     This study is being conducted to further investigate the safety of prolonged exposure to     EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic     who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.   "
120041|NCT01714700|"     Background: The interactive effects of resistance training and dietary protein on hormonal     responses in overweight or obese adults are not clear and remain controversial. Investigators     tested the effect of an isocaloric high-protein diet on body composition, ghrelin, and     metabolic and hormonal parameters during a 12-week resistance training program in untrained     overweight healthy young men.      Methodology: Investigators randomized 18 healthy young males to a standard diet (ST group) or     an isocaloric high protein diet (HP group). Subjects in both groups participated in a 12     week-resistance exercise program. Investigators measured body composition, lipid profile,     homeostatic model assessment of insulin resistance (HOMA-IR) indices, total ghrelin, and     exercise related hormones at baseline and 12 weeks.   "
120042|NCT01714687|"     This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis     (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.   "
120043|NCT01714674|"     Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac     injury. Previous research has shown that type 2 diabetic patients may experience large     increments in cTnT levels over the subsequent hours following a single bout of     moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac     ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent     evidence indicates that ingestion of dietary nitrates dramatically increases the     bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion     injury.      The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT     levels following exercise in type 2 diabetic patients.   "
120044|NCT01714661|"     The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the     cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic     therapy.   "
120045|NCT01714648|"     Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for     IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using     GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.   "
120046|NCT01714635|"     The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS     Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide     statistically better distance-corrected near visual acuity compared to the monofocal control     lens. Complication and adverse event rates associated with each Multifocal IOL will be within     the ISO SPE rate for posterior chamber IOLs.   "
120047|NCT01714622|"     Gastric cancer is still one of the most common malignance in Korea. Because of the popularity     of regular check ups, early detection of gastric cancer has increased, consequently, the     survival of the patients also has increased. In this reason, the interest of outcomes after     gastrectomy for gastric cancer move survival only to quality of life of these patients.      Although the definition of metabolic syndrome is various, but it is normally accepted as a     state that insulin resistance or glucose intolerance combined with hypertension or     hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the     treatment is modification of life style, weight loss and medication. However, in most of the     patients metabolic syndrome is considered not curable disease. Recent studies have shown that     some bariatric surgery offers not only control the overweight but also metabolic syndrome.     The exact mechanism is still unknown but decreased gastric volume and intestinal bypass     itself seemed to play an important role to improve metabolic syndrome over just decreased     weight.      For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied     subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type     is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy,     esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead     decreased gastric volume and/or intestinal bypass, which means this operation could lead     similar effect of bariatric surgery. Already, there have been several retrospective reports     that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no     prospective study about this subject yet in Korea.      The purpose of this study is that evaluating the degree of improvement of metabolic syndrome     after gastrectomy for gastric cancer, and analyze the differences between the type of     operation.   "
120048|NCT01714609|"     Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver     cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of cancer     cells and prevents the formation of new blood vessels that would otherwise help the cancer     spread.      Studies in experimental animals have shown that sorafenib may also lower portal vein pressure     (the pressure of the blood passing from the intestine through the liver.) This study seeks to     determine if sorafenib lowers the blood pressure in liver blood vessels (portal vein     pressure) in patients with cirrhosis who have high portal vein pressure. The study will also     obtain information whether sorafenib is safe in this patient population.      Half of the patients will be given sorafenib and half will be given a placebo (a pill without     any medicine in it.) This allows a comparison of the reactions of people who take sorafenib     to those who do not.   "
120074|NCT01714232|"     The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring     System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other     manufacturers. All meter BG results were compared with plasma results obtained with a     reference laboratory glucose method (YSI Glucose Analyzer).   "
134389|NCT01525797|"     The purpose of this study is to see what a lab test will show and if there is a way to     predict which patients will be more likely to have rejection after receiving a liver     transplant.   "
120049|NCT01714596|"     The goal of this study is to evaluate the effect of treatment of post-op wound infection in     long bones after fracture fixation or joint fusion and either: (Group 1) operative     debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and     IV antibiotics for 6 weeks.      Primary Hypothesis: The rate of treatment failure by one year in Group 1 will be non-inferior     to the rate in Group 2. Treatment failure is defined as wound problems that require surgery     >2 weeks after initial debridement, infection recurrence, infection with a new pathogen,     joint erosion, implant failure, medical problems related to the treatment administration     which necessitates a switch from one arm to the other.   "
120050|NCT01714583|"     The objective of this study is to evaluate the association between positive end-expiratory     pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with     acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid     and Catheter Treatment Trial (FACTT) fluid protocols.   "
120051|NCT01714570|"     Neutropenia is very common in patients received hematopoietic stem cell transplantation, with     median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as     first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the     data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell     transplantation is very limited.      The current study will evaluate the efficacy of piperacillin/tazobactam compared with     imipenem/cilastatin for febrile neutropenia after transplantation.   "
120052|NCT01714557|"     Neutropenia is very common in patients received hematopoietic stem cell transplantation, with     median duration of about 14 days. Almost all neutropenia will suffer from febrile without     prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia     patients of high risks, while in China, major pathogens possess high resistance to     fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate     prophylaxis regimen.      The current study will evaluate the three different regimen:        1. No prophylaxic antibiotic        2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas          activity.        3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam          has highest susceptibility rate among common anti-pseudomonas antibiotics.   "
120053|NCT01714544|"     The purpose of this study is to determine whether Cloderm Cream is effective for topical     treatment of moderate psoriasis over 28 days.   "
120054|NCT01714531|"     The majority of trauma survivors experience prolonged and profound physical and psychosocial     disability, with up to 50% unable to return to productive employment. The Centers for Disease     Control (CDC) estimates that more than 1 million of these individuals experience a mild     traumatic brain injury (TBI) and cost the United States nearly $17 billion each year.     Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that     can lead to vocational and social disability. Long-term cognitive deficits include problems     with memory and attention, and most importantly executive functioning. Depressive and     post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with     cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The     investigators have found that 55% of trauma patients with mild TBI have profound cognitive     impairments in executive functioning at one-year survival. Executive functioning is defined     as a cognitive domain that controls the execution of complex activities of daily living     essential for purposeful, goal directed behaviors. Deficits in executive functioning are the     most disabling of all cognitive impairments and affect a person's ability to manage     effectively in one's personal and professional life. Current literature shows that deficits     in executive functioning contribute to reduced quality of life, difficulty in returning to     work, and persistent psychological distress in various medical and surgical populations.     Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment     and functional disability in patients with TBI. The overall goal of cognitive rehabilitation     is not only to improve a person's ability to process and interpret information but to     increase self-confidence and self-efficacy for coping with emotional distress. Despite     evidence supporting the use of cognitive rehabilitation, few studies have systematically     addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators     propose to conduct a three-group randomized controlled trial to determine the efficacy of     Goal Management Training (GMT), a structured manual-based intervention targeting executive     functions that impact a person's ability to carry out daily tasks. The investigators     hypothesize that telephone-based GMT will improve cognitive functioning, functional status,     and psychological health in trauma survivors with mild TBI. Emerging research suggests that     telephone rehabilitation is a feasible and effective alternative (with much broader     applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited     access to rehabilitation services due to financial constraints and mobility and geographic     restrictions that render clinic-based rehabilitation impractical. This clinical trial will     recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning.     Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2)     telephone-based attention-control; or (3) usual care. Primary outcomes will include observed     and self-reported executive functioning and self-reported functional status as measured by a     battery of standardized and previously validated cognitive tests and instruments, including     the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and     the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and     PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist -     Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after     hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital     discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate     evidenced-based cognitive strategies to a trauma population that has difficulty returning to     productive life both inside and outside the home due to profound functional and psychological     disability. Findings from this study will support future research to improve the cognitive,     functional and psychological health of patients following major trauma through innovative     rehabilitation interventions and delivery methods.   "
120055|NCT01714518|"     The purpose of this study is to assess efficiency and safety of cryobiopsy compared to     video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases     (ILD). To that end, this non-interventional study prospectively collects data from patients     undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic     approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to     VATS if this procedure is reasonable. The information gained by this study will help to     assess the significance of cryobiopsy in contrast to VATS in this particular disease group.   "
120056|NCT01714505|"     An unblinded, randomized, cross-over design with each patient participating in two 40-hour     outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)     Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a     hospital based clinical research center. The principal goal is to validate a smart     phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of     CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger     home-based trials of CTR.   "
120070|NCT01714284|"     This is a multicenter randomized controlled clinical trial evaluating the impact of a     structured non pharmacological intervention consisting in intensive weight reduction     (qualitative and quantitative changes in diet associated with physical exercise) compared to     an intervention based on a simple informative counseling about the utility of weight loss for     clinical control of psoriatic disease.   "
120058|NCT01714479|"     Warfighters often experience physical overload, as the uniform and associated gear that they     carry burdens them with substantial loads. The loads increase energy expenditure to levels     that exceed a Warfighter's typical energy intake. The typical assault load is approximately     25 kg, although loads as high as 55 kg are often carried, which when combined with extreme     energy expenditures can degrade health and performance, and increase the risk of injury.     Branched-chain amino acid (leucine) supplementation may confer protection against the     negative effects of operational stress by stimulating muscle protein synthesis and reducing     degradation. This study will determine if leucine-enriched nutrition supplementation confers     protection against the negative consequences of sustained load carriage exercise, and explore     the mechanisms by which leucine might impart protection.   "
120059|NCT01714466|"     A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel     cleansing solution (MOVIPREP®)   "
120060|NCT01714440|"     The major aim of this research study is to investigate the relationship between genetic     variation in DNA (inherited code material in the cells of the body) and factors affecting     transplant outcomes, like the drugs people receive or the way their immune systems work, for     example. To do this, investigators will collect blood samples from participants. Genetic     material will be separated from each blood sample and analyzed, looking for genetic     variation.   "
120061|NCT01714427|"     The purpose of this study is to investigate the local and systemic inflammatory response and     haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to     determine the feasibility of imaging techniques to quantify lung inflammation in an adapted     human endotoxin instillation model.      The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.   "
120062|NCT01714414|"     A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained     virological suppression defined as HIV-RNA <50 copies/ml of 3 different doses of Fozivudine     in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of     treatment in ART naïve, non subtype B HIV-1 infected individuals from Tanzania and Ivory     Coast.   "
120063|NCT01714375|"     The goal of this study is to determine whether daily assessment and feedback of workers'     noise exposures leads to more effective use of hearing protection and prevention of     noise-induced hearing loss.   "
120064|NCT01714362|"     Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This     phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac     features of this reflex include hypotension, dysrhythmias, atrioventricular block. These     cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs.     Patients with existing cardiovascular disease are in risk of complications. Cardiovascular     system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic     activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5     minutes electrocardiography has been found useful for prediction of hypotension and     bradycardia during induction of general anaesthesia and during spinal block. The aim of this     study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV     analysis for ANS activity assessment, measured prior to the ophthalmic surgery.   "
120065|NCT01714349|"     Nerve Transfer surgery can provide improved hand function following cervical spinal cord     injuries   "
120066|NCT01714336|"     Does tranexamic acid improve the perioperative care of those patients treated surgically for     hip fracture by decreasing the proportion of patients requiring transfusion and decreasing     total perioperative bleeding.   "
120067|NCT01714323|"     Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public     Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers     in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized     each year, and hospital admission offers a teachable moment for intervention.     Hospital-initiated smoking cessation intervention is effective, but only if contact continues     for more than 1 month after discharge. The challenge is to translate this research into     clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals     can adopt. The major barrier is sustaining contact after discharge. This project tests an     innovative strategy to streamline the delivery and maximize the uptake of post-discharge     smoking interventions.      Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of     evidence-based tobacco treatment (counseling and medication) after hospital discharge,     thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco     abstinence.      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll     1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All     subjects will receive a brief in-hospital smoking intervention and be randomly assigned at     discharge to either Standard Care (passive referral to their state quitline) or Extended     Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved     medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and     refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive     Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR     aims to encourage medication adherence and enhance counseling efficiency by identifying     smokers who need post-discharge support. Immediate transfer of a patient from automated IVR     call to live telephone counselor will facilitate a successful connection to counseling.      Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention     effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month     follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment     utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine     the intervention's effect on hospital readmissions and mortality in the 6 months after     discharge.   "
120068|NCT01714310|"     This project will characterize children and adolescents with severe mood dysregulation (SMD)     and conduct a pilot study of combination pharmacotherapy as a basis for future intervention     trials.      Eligible participants assessed for SMD will have 4 weeks open titration with lisdexamfetamine     (LDX) to optimal dose, followed by double-blind randomization to fluoxetine (N=25) or placebo     (N=25) in combination with optimized LDX for an additional 8 weeks. Participants will be     monitored for clinical response and adverse events.      Specific aims are:      #1: To define youth meeting SMD criteria in terms of psychiatric comorbidity, neurocognitive     functioning, and a potential bio-signature derived from electroencephalography (EEG).      Specific hypotheses to be tested include: 1) that SMD participants will differ in comparison     to non-SMD individuals in our pre-existing database on patterns of a) psychiatric     comorbidity, b) symptoms, c) behavioral ratings, and d) neurocognitive functioning, and 2)     that a distinct EEG bio-signature will be confirmed in individuals formally diagnosed with     SMD.      #2: To conduct a preliminary study of sequential pharmacotherapy for SMD with a stimulant     followed by randomized, placebo-controlled selective serotonin re-uptake inhibitor (SSRI)     therapy to evaluate the feasibility of recruitment and enrollment and assess the suitability     of the proposed combination treatment as a basis for future clinical investigations.      Specific hypotheses to be tested include: 1) that significant improvement in Clinical Global     Impression - Improvement -SMD (CGI-I-SMD) scores and other secondary measures are evident     after open-label LDX titration; 2) that participants randomized to fluoxetine will     demonstrate additional significant improvement in CGI-I-SMD scores and other secondary     measures in comparison to participants randomized to placebo; 3) that combination LDX and     SSRI therapy is safe and well tolerated, and 4) that EEG profiles will normalize with     treatment.   "
120069|NCT01714297|"     The purpose of this study is to determine if there are differences in clinical events, i.e     bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight     Heparin) is initiated before or after surgery.   "
120071|NCT01714271|"     This family environment-focused health behavior change intervention is being carried out by     extensively trained community health workers (promotores) familiar with the community in East     Los Angeles. The hypothesis being tested is that home environment-focused health behavior     change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease.     The community health workers will provide most of the health promotion counseling. The     promotores will provide up to 16 counseling sessions to a designated adult family member     without diabetes. The sessions will focus on improving the home environment in order to     reduce television viewing, increase fruit and vegetable intake, decrease intake of refined     carbohydrates, prompt more frequent monitoring of body weight and increase daily physical     activity. The lifestyle change goals will be tailored to the families' capacity for change     and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov     messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of     daily moderate physical activity.   "
120072|NCT01714258|"     The two gold standard for cardiac output (CO) measurements, i.e., the Fick method and     pulmonary artery thermodilution , are both invasive methods, requiring the use of central     venous catheter and Swan-Ganz catheter, respectively.      With the aim to reduce the risks for the patient, a big research effort has been made to     investigate minimally invasive or non-invasive methods. Investigators sought to evaluate the     effectiveness of a non invasive method to estimate CO in mechanically ventilated patients.The     method is based on prolonged expiration, and relies on measurement of gas concentrations and     flow rate. Investigators designed, realized, and characterized a system to induce passive     prolonged expirations when connected to the patient circuit.      CO is then calculated using an algorithm based a modified version of the Fick equation and     the results are compared with the ones obtained by thermodilution.      Several advantages can be introduced by the prolonged expiration technique: non-invasive     measurement, easy implementation, independency from operator ability among others.   "
120075|NCT01714219|"     Incontinence is one of the most common complications of radical prostatectomy. The continence     rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP).     However, some reports suggested that posterior reconstruction (PR) behind vesicourethral     anastomosis could improve early recovery of continence during open, laparoscopic or     robot-assisted radical prostatectomy.      But, recent prospective studies reported no benefit of PR after RALP, which was the opposite     result of those of previous studies. However the PR techniques used in these prospective     studies seem to be quite different from the previous techniques. They seem to have used     single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the     Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional     reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder     neck.      Our group identified this anatomic structure as the posterior counterpart of the detrusor     apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more     appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the     key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step     reconstruction between MDFR and PDA could be enough for PR. We previously investigated     whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would     improve continence recovery compared with the standard RALP technique without PR. And our     retrospective study demonstrated that this new PR technique during RALP significantly     shortens the time to the recovery of continence compared with the standard technique, which     does not incorporate PR (Int J Urol, 2012;19:683-7).      Thus, we plan to validate this result by a well-designed, prospective, randomized controlled     study.   "
120076|NCT01714206|"     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)     affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of digoxin.     The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.   "
120077|NCT01714193|"     The purpose of this study is to investigate whether there is a drug-drug interaction between     multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive     containing ethinyl estradiol and levonorgestrel. The safety and tolerability of canagliflozin     will also be assessed in healthy volunteers.   "
120078|NCT01714180|"     Studies have shown that different percentages of body fat can alter the way drugs are     distributed in the body. This study will use blood samples taken at different time points for     patients taking acyclovir to determine if higher body weights affect drug exposure. The     information gathered from this study will help understand if patients with higher body     weights need a different dosing plan.      Patients receiving acyclovir as standard of care will be enrolled into this study. They will     have blood draws once before they take acyclovir and 10 times after they take the acyclovir     (over a total of 12 hours). These patients will be in the hospital already and will not need     to make additional trips back to have blood drawn. A total of about 4—5 tablespoons of blood     will be drawn for this study. 7 obese patients and 7 matched, non—obese patients will be     enrolled into this study.   "
120079|NCT01714167|"     Stroke is one of the leading causes of disability in the world, and stem cell -     transplantation provides a promising approach for rehabilitation. The main objective of this     study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow     mesenchymal stem cells in patients with chronic stroke.   "
120080|NCT01714154|"     This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate     the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with     ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy     controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period     1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in     Period 2, with a washout phase of at least 9 days between treatments.   "
120081|NCT01714141|"     This pilot study's main goal is to develop and preliminarily test a technology-based     intervention to improve asthma medication adherence in urban African American emerging adults     (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will show     improvements in motivation to adhere to asthma medications and self-reported adherence     compared to the comparison condition at 1- and 3- month follow up.   "
120082|NCT01714128|"     A significant number of all invasive breast cancers are hormone sensitive and may be     candidates for treatment with hormonal therapy.      This project will assess the ability and usefulness of imaging hormone-receptor status in     breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES),     an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given     in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .   "
120092|NCT01713998|"     Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on     the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study     images will be obtained pre-treatment, immediately post-treatment, and at each follow-up     visit.   "
120083|NCT01714115|"     This is a single patient investigative treatment study. The patient was diagnosed with a     retinal tumor in one eye. In the last 2 years, the patient has been treated with all     available and conventional therapies, including intraocular injections of Avastin and     Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and     caused an eventual decline in central vision. Aflibercept has been shown to be effective     against the growth of new vessels, secondary to macular degeneration. This study proposes     that it may also be more effective in treating this particular patient and case. The study     treatment plan is for 6 months initially, with the intention to continue treatment.   "
120084|NCT01714102|"     Metabolic syndrome is a serious health condition that affects about 35 percent of adults and     places them at higher risk of cardiovascular disease, diabetes, stroke and diseases related     to fatty buildups in artery walls. The underlying causes of metabolic syndrome are obesity,     being overweight, physical inactivity and genetic factors. In recent decades, the prevalence     has increased dramatically in the United States. Lifestyle interventions including dietary     modification, physical activity and weight loss form the basis of treatment for these     patients. However, research has shown that even when people are able to incorporate these     changes, they often revert back to their usual lifestyle resulting in weight gain and     continued risk for diabetes and heart disease.      Resveratrol, a natural plant derived compound found in grapes, peanuts and red wine, has been     found to reverse some of the features of the metabolic syndrome (insulin resistance, high     triglycerides, high blood pressure) in rodents. These improvements occurred without weight     loss, and were proven to be a direct result of resveratrol ingestion. Other studies reveal     improvement in cardiovascular health, tumor suppression, and longevity. However, there are     few studies investigating these beneficial effects in humans. Investigators propose to prove     that resveratrol, administered to subjects with the metabolic syndrome, under controlled     conditions of weight stability, common diet, and strict compliance with the study drug, will     improve the symptoms of the metabolic syndrome, thereby decreasing the chance of developing     diabetes or heart disease.   "
120085|NCT01714089|"     The purpose of this study is to determine whether RNS60 is effective in the treatment of     RR-MS compared to interferon beta-1a.   "
120088|NCT01714050|"     Major depression is a highly prevalent, chronic, and debilitating mental health problem with     significant social cost that poses a tremendous economic burden. Winter seasonal affective     disorder (SAD) is a subtype of recurrent major depression involving substantial depressive     symptoms that adversely affect the family and workplace for about 5 months of each year     during most years, beginning in young adulthood. This clinical trial is relevant to this     public health challenge in seeking to develop and test a time-limited (i.e., acute treatment     completed in a discrete period vs. daily treatment every fall/winter indefinitely), palatable     cognitive-behavioral treatment with effects that endure beyond the cessation of acute     treatment to prevent the annual recurrence of depression in SAD.      Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light     therapy on depression recurrence status, symptom severity, and remission status during the     next winter season (i.e., the next wholly new winter season after the initial winter of     treatment completion), which we argue to be the most important time point for evaluating     clinical outcomes following SAD intervention.      Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less     severe symptoms, and a higher proportion of remissions than light therapy in the next winter.     The study is designed to detect a clinically important difference between CBT and light     therapy in depressive episode recurrences during the next winter, the primary endpoint, in an     intent-to-treat analysis.      Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission     status at post-treatment (treatment endpoint).      Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.   "
120089|NCT01714037|"     Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination     with standard of care chemotherapy for the first- and second-line treatment of advanced     NSCLC.   "
120090|NCT01714024|"     The purpose of this research study is to compare the healing differences of two metals     (trabecular vs. standard titanium) that are used for dental implants. In addition;     investigators will be examine these differences in the gene expression profiles in subjects     with three conditions associated with delayed healing: diabetes and osteoporosis.      The study will last at least 11 weeks consisting of 6 appointments. All visits will be     carried out at the GO Health Center within the UNC School of Dentistry. Visits will last     between 30 minutes to 3 hours depending on the particular visit.      The visits will consist of: Obtaining consent, doing a health history, measuring vital signs,     doing dental exams of the teeth and gums, collecting samples of saliva dental radiographs     (X-rays), a teeth cleaning, having 4 temporary mini test cylinders placed in areas of the     lower jaw where teeth are missing and implant surgery to place up to four permanent implants.   "
120091|NCT01714011|"     Introduction:      Schizophrenia is a serious mental illness. For majority of patients it is a lifetime     condition,characterized by intermittent episodes of hospitalization due to relapse or acute     symptom exacerbation. The nature and course of the disorder impose significant social and     economic burden. Relapse is costly, with hospitalization accounting for a substantial portion     of healthcare expenses. Second generation antipsychotic side effect such as metabolic     syndrome and diabetes mellitus will contribute additional costs to the treatment.      Many studies have since then provided convincing evidence for a high risk of diabetes and     other glucose abnormalities, metabolic syndrome and mortality due to elevated cardiovascular     risk in patients with schizophrenia.      However many studies has shown the effectiveness and safety of aripiprazole and     ziprazidone.In one of the study, aripiprazole showed improvement of negative schizophrenic     symptoms by 25% and 50% of functioning level from baseline. In term of safety, antipsychotics     considered to have a safer metabolic profile were amisulpride, ziprasidone and aripiprazole.      Study objectives:        -  To investigate the safety and efficacy of ziprazidone versus aripiprazole in the          treatment of schizophrenia patients with metabolic syndrome and diabetes mellitus.        -  To investigate the reversibility of metabolic syndrome and diabetes parameters following          the treatment with ziprazidone versus aripiprazole.      Hypotheses:      * The proportion of reversibility of metabolic syndrome and diabetes parameters is higher     following the treatment of ziprazidone than aripiprazole.   "
120093|NCT01713985|"     Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups.     Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the     left side. Group B will receive Thermage on the right side of the face and neck and     Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment.     Study images will be obtained pre-treatment, immediately post-treatment, and at each     follow-up visit.   "
120094|NCT01713972|"     This phase I trial studies the side effects and best dose of dabrafenib and pazopanib     hydrochloride when given together in treating patients with advanced malignant tumors.     Dabrafenib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth   "
120095|NCT01713959|"     Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two     treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at     7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days     post-treatment #2.   "
120096|NCT01713946|"     This study will evaluate the efficacy and safety of two trough-ranges of everolimus given as     adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory     partial-onset seizures.      The study consists of 4 phases for each patient [Baseline phase: From Screening Week -8 (V1)     to randomization visit at Week 0 (V2)], Core phase, from randomization at Week 0 (V2) to Week     18 (V11)], Extension phase from Week 18 (V11) until 48 weeks after the last patient has     completed the core phase, and Post Extension Phase.   "
120097|NCT01713933|"     This study is an evaluation of the Ulthera® System used to treat the upper arms for     improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm     treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.   "
122669|NCT01680328|"     This trial is conducted in Europe. The aim of this trial is to assess and describe the pain     in relation to subcutaneous (under the skin) injection of different combinations of injection     speed and volume with respect to acceptance of the injection pain and backflow.   "
120098|NCT01713920|"     A majority of Korean doctors tend to add other antihypertensive rather than to titrate the     same drug.      However, we try to induce doctors to titrate the Sevikar than to add other antihypertensive     if patients are not controlled with Sevikar 5/20mg(amlodipine 5mg + omlesartan 20mg). As     above, for patients who are not controlled with Sevikar 5/20mg, doctors will proceed to other     prescription pattern with other choices of titration to Sevikar 5/40, 10/40mg.      It is important to evaluate BP lowering efficacy of Sevikar through the titration step in     patients uncontrolled with Sevikar low dose. Thus, this study is designed to demonstrate the     efficacy of Sevikar by titration in patients who are not controlled their BP with low dose of     Sevikar.   "
120099|NCT01713907|"     Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on     the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study     images will be obtained pre-treatment, immediately post-treatment, and at each follow-up     visit.   "
120100|NCT01713894|"     The purpose of this study is to assess in a pilot randomized controlled trial the following     PICOT question: In parents facing extreme premature delivery, does the use of an existing     validated visual decision aid as compared to standard counseling, reduce the primary outcome     of parental decisional conflict? Furthermore, is such a decision aid understood and     applicable across differing populations of different ethnic backgrounds and social classes?   "
120101|NCT01713881|"     This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were     found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and     timing of completion of repeat colonoscopies pre and post establishment of a polyp registry     (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively     identified from all the patients who underwent colonoscopy and were found to have a tubular     adenoma (Group 1-2004 to 2006, Group 2 2007-2008).   "
120102|NCT01713868|"     The goal of this proposal is to address serious and ongoing challenges related to adherence     to public health recommendations known to reduce the risk of SIDS. Adherence has reached a     plateau at an unacceptably low level both in the overall US population and especially in     Black infants leading to a halt in the decline in infant mortality and a widening in the     racial disparity in infant mortality. The current proposal is a collaborative effort that     will capitalize on the extensive experience of the investigators in studying barriers to     adherence to safe sleep practices to develop two complementary, culturally competent,     intervention strategies and to test the effectiveness of each strategy as well as both     strategies in combination. Innovative aspects of the Social Media and Risk-reduction Training     of Infant Care Practices (SMART) study include its: 1) unique collaboration of leaders in the     field; 2) leveraging of the currently operational infant care practices study infrastructure     and hospitals; 3) use of two complementary interventions with the potential for synergistic     impact; 4) use of social marketing strategies;5) use of mobile technology (mHealth) to     deliver messages; and 6) collaboration with community resources and expertise. The SMART     study will have four arms in which 16 hospitals are randomly assigned to one of the following     study groups: 1) Safe Sleep Nursery Education and Breastfeeding mHealth messaging; 2)     Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe Sleep Nursery     Education and Safe Sleep mHealth messaging; 4) Breastfeeding Nursery Education and     Breastfeeding mHealth messaging. A total of 1600 mothers will be recruited (100/hospital),     with 400 in each study group. The primary aim is to assess the effectiveness of the     interventions aimed at promoting safe sleep practices compared with the breastfeeding control     interventions. The secondary aim is to assess potential mediating factors that may explain     the intervention effects on infant care practices and that may inform areas for future     improved intervention approaches. With the successful completion of the SMART study,     effectiveness data will have been provided for two interventions to improve adherence to safe     sleep practices that are practical to disseminate nationally in multiple diverse settings.   "
120103|NCT01713855|"     The purpose of this study is to determine how children with a history of severe, chronic     Idiopathic Thrombocytopenic Purpura (ITP) who were treated with rituximab might respond to     vaccines. Eligible patients are previously or currently enrolled in a study entitled Open     Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura     in Children and Adolescents and have decided to obtain an inactivated influenza vaccination.     These patients will be invited to provide one blood sample prior to vaccination and a second     sample following vaccination to quantify immune response to vaccination.   "
120104|NCT01713842|"     Phase 1:      Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is     performed using PMR-AS.      The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting     purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale     (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST)     [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).      At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.      Phase 2:      All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3     months. Two arms are possible according to the PMR-AS. Either the classical GC treatment     (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .   "
120105|NCT01713829|"     The purpose of this study is to determine the extent to which consuming a cranberry beverage     modifies immune function, specifically related to γδ T cells and other innate immune cells.     It is hypothesized that cranberry components will interact with immune cells to activate     signaling pathways that enhance cell function. Enhanced immune cell function should result in     reduced number, duration, and severity of cold and flu symptoms.   "
120106|NCT01713816|"     Antioxidants are important for having a good memory and for smart thinking when people get     old, and that is important for everyone's quality of life. This research will find out if     normal aging and Alzheimer's disease use up brain antioxidants. It will develop a new imaging     tool that can help doctors to stop cognitive decline.   "
120107|NCT01713803|"     This is a randomized, double blind, placebo controlled study in opioid dependent subjects.     Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo,     with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as     follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale     (COWS), subject-rated assessments, and a urine drug screen.   "
120108|NCT01713790|"     This study aims to examine long term effects in the training gain stage of the falls     management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical     functional performance after mechanical SR-WBV, dance therapy and strength training     intervention in a frail elderly population.   "
120140|NCT01713374|"     The purpose of this study is to determine whether interventions aimed at increasing     sympathetic tone modify endothelial function measures as assessed by the measurement of     flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the     three interventions under study will increase FMC while causing a blunting in FMD.      Further, the investigators plan to study the circadian variability of FMC and FMD. The     investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the     early hours.   "
120109|NCT01713777|"     The United States Food and Drug Administration (FDA) has specific rules generic drug     companies must follow to get a generic copy of a seizure medication approved. Currently, the     FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy     and who take just one dose of the generic drug followed by a series of blood tests. Some     people with epilepsy and their physicians have complained about side effects or loss of     seizure control when taking generic drugs, but no one knows if these complaints are truly     because of problems with the generic drugs.      When the FDA tests generic copies of lamotrigine (LTG), the blood levels measured after     volunteers receive the generic lamotrigine tablets are allowed to fall within a specific     range. This research will test whether two different manufacturer's generic lamotrigine, that     fall in different parts of that range, perform in a similar way when given to people with     epilepsy every day over a several week period. The two products will be called GENERIC A and     GENERIC B.      The generic forms of the study drug lamotrigine to be tested in this study are approved by     the FDA for the treatment of seizures.   "
120110|NCT01713764|"     The study is a small pilot, designed to provide data regarding the feasibility and     acceptability of conducting such a study on a larger scale. The present study is a randomized     controlled clinical trial comparing two mindfulness-based lifestyle modification programs to     help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and     the other using a moderate-carbohydrate diet promoted by the American Diabetes Association     (ADA). Intervention content will include information about nutrition (carbohydrate     restriction or American Diabetes Association recommended diet) and emotion regulation and     mindful eating strategies.   "
120111|NCT01713751|"     The aim of this study is to determine the surgical site infection rate and patient     satisfaction for subcuticular versus interrupted mattress suture in closure of skin at     Cesarean delivery in obese patients.   "
120112|NCT01713738|"     The purpose of the study is to evaluate the safety and efficacy of rituximab in children ages     18 months to 18 years, who have severe, chronic ITP. Eligible patients with either primary or     secondary ITP are treated with rituximab once a week for 4 doses, and then followed for up to     one year. Response is defined as having a platelet count greater than or equal to 50,000/mL     on four consecutive weekly measures beginning anytime in weeks 9 - 12.   "
120113|NCT01713725|"     Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals     for at least 6 weeks, which may be accompanied by angioedema. While the wheals are transient,     the resolution of angioedema is slower than wheals and could take up to 72 hours. The natural     course of chronic urticaria is self-limited, with spontaneous remissions and occasional     relapses. The investigators calculated a 0.6% (95% CI(Confidence Interval): 0.4-0.8)     prevalence in a population study. It has a great impact on patients' quality of life. In a     recent national survey on patients attending Allergy Department, chronic urticaria was the     disease with greater impact on mental quality of life out of all allergic diseases.      In spite of the high morbidity of this disease and the impact in quality of life, there is no     available treatment. Last guidelines recommend initiating treatment with antihistamine and if     there is no response to increase the dose off-label up to four-fold; systemic corticosteroids     are also recommended in short tapering and if no response, the only treatment with clinical     evidence to be employed is cyclosporine. As additional data, the treatment cost of this     disease has been calculated in 2047$/year.      In past years it has been employed the monoclonal humanized anti-Immunoglobulin IgE (iGE)     antibody (Omalizumab) to treat moderate to severe asthma with good results. The rationale for     this approach in chronic urticaria is that Omalizumab inhibits the binding of IgE to the high     affinity IgE receptor (FceRI) which decreases the FceRI expression on the surface of mast     cells and basophils so that immunoglobulin G cross linking of the alpha subunit and basophil     degranulation is prevented.The hypothesis the investigators are working on is that monoclonal     IgE antibody Omalizumab could be effective in controlling chronic urticaria symptoms in     patients non respondent to conventional therapy. The investigators hypothesize that     Omalizumab is able to revert the basophil or mast cell activation present in chronic     urticaria.   "
120114|NCT01713712|"     The purpose of this study is to evaluate the effect of access to nutrition services on     pregnancy outcomes in the obese urban population. There are many studies that have shown that     obesity has a negative impact on pregnancy. However, currently there are only a few small     studies that specifically look at ease of access to nutrition services in an obese urban     population and the effect this has on maternal weight gain and pregnancy outcomes. This study     will compare two groups of pregnant women with a BMI of 30 or greater. The investigators     hypothesize that access to nutritional services will lead to decreased weight gain during     pregnancy and improved pregnancy outcomes.   "
120115|NCT01713699|"     The purpose of this study is to determine whether the quantitative detection of circulating     tumor cells (CTCs) in patients with Epcam expressing tumors can be used compared to standard     qualitative method - cytology both in the cerebrospinal fluid of patients, clinically     suspected for leptomeningeal metastases.   "
120117|NCT01713673|"     Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham     treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™     treatment will have a greater reduction in axillary sweating compared to subjects receiving     Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at     7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will     be completed to compare the amount of axillary sweating compared to baseline.   "
120118|NCT01713660|"     The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract     surgery.   "
120119|NCT01713647|"     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE     products by measurement of Plasma concentrations of Amlodipine ,Losartan, Carboxylic acid     losartan metabolite & Hydrochlorothiazide in plasma and calculation of the bioequivalence     parameters from those measurements followed by ANOVA and 90% confidence interval statistical     evaluation.   "
120141|NCT01713361|"     The purpose of this study is:        -  To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding          and VTE, in patients undergoing total knee arthroplasty.        -  To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less          than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.   "
120328|NCT01710904|"     This non-interventional, observational study is set up on request of the Belgian     reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief     and constipation in daily clinical practice in Belgium compared to the previous analgesic     treatment with prolonged release oxycodone. Only patients eligible for Targinact®     reimbursement in Belgium are included.   "
120120|NCT01713634|"     Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a     condition that affects millions of men and women on Earth each year. Many countermeasures to     bone loss have been proposed, and many have been evaluated to some degree. To date, those     showing potential have focused on either exercise or pharmacological interventions, but none     have targeted dietary intake alone as a factor to predict or minimize bone loss during     spaceflight. The investigators proposed to document how the ratio of acid precursors to base     precursors in the diet is related to directional changes in markers of bone resorption and     formation during flight and recovery from flight. There is a high likelihood for success in     predicting the extent of bone loss from dietary intake patterns of astronauts during     spaceflight, given that this concept is strongly anchored in data obtained from ground-based     experiments in our laboratory and others. The notion of manipulating diet to minimize bone     loss could also have significant social and economic impacts for NASA and for the general     public - especially given the increasing trends for diets that are high in animal protein and     low in fruits and vegetables. The results of the proposed experiments will lead to     development of a dietary countermeasure for bone loss consisting of a balanced diet with no     associated risks for side effects that might be present with pharmaceuticals or supplements,     no requirement for payload mass, and no additional crew time necessary during flight.   "
120121|NCT01713621|"     This study aims to investigate the concentration dependent effects of OZ439 on the clearance     of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum     inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD     (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based     dosing. The adaptive investigation of a range of doses will provide the best chance of     accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth     dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal     concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be     confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on     parasitaemia will be investigated.   "
120122|NCT01713608|"     A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration     of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:        -  To determine the safety and tolerability of ascending doses of OZ439 OD for three days.        -  To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.        -  To identify the maximum tolerated dose of OZ439 administered.   "
120123|NCT01713595|"     To determine if an inhaled hypertonic saline solution has any effect on lung function in     patients with acute respiratory distress syndrome (ARDS).   "
120124|NCT01713582|"     The primary purpose of this study is to determine the recommended dose (RD) of OTX015/MK-8628     for further phase II studies, in participants with acute leukemias (acute myeloid leukemia     [AML; de novo and secondary to a myelodysplastic syndrome] or acute lymphoblastic leukemia     [ALL]) or hematologic malignancies (diffuse large B cell lymphoma [DLBCL] or multiple myeloma     [MM]).   "
120125|NCT01713569|"     Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical     facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound     exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48     hours post-treatment, on the day of their rhytidectomy. Study images will be obtained     pretreatment, immediately post-treatment, and at the follow-up visit.   "
120126|NCT01713556|"     The purpose of this study is to test whether propranolol, when given during a re-evocation of     a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that     memory.   "
120150|NCT01713244|"     RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use,     safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small     vessels while destroyed the tumor cell in situ. Surgical resection is the most widely     accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian     countries. But the effectiveness of hepatectomy was depressed because of the high recurrence     rate. The spreading of the cancer cell along the portal vein or the hepatic vein system     during the operation account for the tumor recurrence. Using RFA to ablate and block the     small vessels around the tumor before resection will reduce the spreading of the cancer cell.     Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence     rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study     was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone     for the treatment of advanced HCC.   "
120127|NCT01713543|"     Background: Falls are the leading cause of injury among older adults in Singapore, but falls     among the elderly can be preventable and the risks are predictable. Translating this     understanding of falls etiology into an integrated clinical and public health program that is     accessible to the elderly is a critical health services delivery challenge.      Hypothesis: An evidence-based program of screening, risk modification and physical therapy     delivered in a community setting will reduce recurrent falls incidence among a high-risk     group of elderly recently discharged to the community.      Methodology: This randomized controlled trial targets patients seen at Emergency Department     (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged     to home. Upon signing the informed consent form, the participants will be followed up for     nine months from the baseline assessment during which the participants are randomized into     either a control or the intervention group. The participants in the intervention group will     be provided with a multifactorial program of screening, risk modification and physical     therapy focused on progressive strength, balance, and gait training either as an     individualized program or a group setting in the community for the first three months from     the date of randomization. The number of recurrent falls will be monitored via a falls     prevention diary maintained by (or for) each participant.   "
120128|NCT01713530|"     This trial is conducted in Africa, Europe and the United States of America (USA).      The aim of the trial is to compare the difference in change in glycosylated haemoglobin     (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs     (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.   "
120129|NCT01713517|"     The purpose of the study is to determine whether long lasting insecticidal nets and indoor     residual insecticide spraying, alone or in combination, are effective for controlling     insecticide resistant anopheles mosquitoes for malaria prevention.   "
120130|NCT01713504|"     The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and     more accessible compared to those that we have already thanks to a proteomic approach. This     will help the investigators to diagnose the this disease.   "
120142|NCT01713348|"     To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic     control by;        1. regularly checking and understanding Continuous Glucose data & trend arrows at times          other than the standard pre-meal bolus calculation test times and        2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care          Professional (HCP) and adjusting behaviours & therapy from interpretation of the          Continuous Glucose profiles.   "
120333|NCT01710839|"     To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease     the total number of intravitreal injections in a year for ischemic central retinal vein     occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to     standard of care   "
120131|NCT01713491|"     At the acute stage of cerebral ischaemia, the only effective drug that increases the     proportion of patients who survive without dependency is thrombolytic therapy by intravenous     (i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice     with similar results than in trials, in various places of the world including Europe and     Japan.      Stroke and dementia are closely related. About one patient in ten has dementia before a     first-ever stroke, and more than one in three has dementia after a recurrent stroke.     Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing     cognitive impairment without dementia is associated with a higher rate of     institutionalisation within 3 years. In many patients cognitive impairment is due to the     summation of the effects of vascular and Alzheimer lesions of the brain.      More and more patients nowadays who are eligible for rt-PA are already known as demented at     admission. A retrospective study conducted in a cohort of patients with dementia who had an     ischaemic stroke and were treated by rtPA suggested that there is no increased risk of     cerebral bleeding and death as compared with non demented patients. However, pre-existing     cognitive impairment is possibly associated with (i) an increased risk of bleeding in     patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect of     rt-PA on the brain tissue.      Japanese patients differ from European patients by a higher risk of spontaneous intracranial     haemorrhage, and a higher proportion of patients with small-vessel diseases.      The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke     patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as a     modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive impairment     or dementia. The secondary objectives are to determine whether (i) they have an increased     risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients who have a     poor outcome is lower than expected from the placebo group of randomised trials for patients     with a similar range of baseline severity, and (iii) the influence of the cognitive state on     outcome differs between Japanese and European patients.   "
120132|NCT01713478|"     The prevalence of hepatic cirrhosis in Romania is very high, with a 10-year mortality of     34-66%. Upward trend of mortality is observed. It is known that cirrhosis is associated with     cardiac abnormalities. These can induce several complications of cirrhosis, and increase     postoperative mortality. Therefore, it is a major public health issue and research in this     field should be a priority.      Few studies evaluated the cardiac function in cirrhotic patients, using only conventional     echocardiography. However, this allows only the late diagnosis of cardiac dysfunction, which     might be already irreversible. Consequently, description of new parameters, which could     detect early dysfunction, becomes essential. There is no study designed to estimate intrinsic     myocardial properties in cirrhosis. New methods (Tissue Doppler and Speckle-tracking     echocardiography) could be essential to detect early cardiac dysfunction. The exact role of     biological markers in the diagnosis of cardiac dysfunction remains to be clarified. Impaired     cardiac function coupled with augmented vascular function could be the model for cirrhotic     patients. This type of ventriculo-arterial interaction has never been described.      The main objectives of our project are:        1. to investigate the mechanisms which lead to cardiac dysfunction;        2. to describe new parameters for the early diagnosis of cirrhotic cardiomyopathy;        3. to describe the type of ventriculo-arterial interaction;        4. the association between biological markers and echo parameters.   "
120133|NCT01713465|"     The objective of the proposed study is to design and evaluate a touch screen computer based     multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse     Indian settings including urban, rural and slum in the State of Bhubaneshwar. The study     objective is to improve metabolic syndrome related knowledge, attitude and practices among     individuals using the proposed interactive, bilingual computer based educational program.   "
120134|NCT01713452|"     Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate     for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than     expected for a clean-contaminated operative classification. The ideal stoma site closure     technique is still debated in the current literature. The aim of this study was to compare     the rate of SSI following two different stoma closure techniques, primary closure versus a     skin approximating purse string closure, in a multi-center randomized controlled trial. The     investigators hypothesize that purse string closure technique will have a lower rate of SSI     than primary closure technique.   "
120135|NCT01713439|"     The patient's have neuroblastoma that has come back, or not gone away. The cancer is harder     to treat now. The investigators would like the patient's to be in this research study to     determine the safety and dosage of special cells that may make the patient's own immune     system fight the cancer. To do this the investigators will put two special genes into     neuroblastoma cancer cells that have been grown in the lab. The genes put in make the cancer     cells produce lymphotactin, a natural substance that attracts immune system cells to the     cancer, and IL-2 a natural substance that may help the immune system kill cancer cells. Some     of these cells will then be put into the patient's body. Studies of cancers in animals and in     cancer cells that are grown in laboratories suggest that substances like lymphotactin and     IL-2 do help the body kill cancer cells. A treatment similar to this has been used in twelve     children previously and similar treatments are being used in adults with other cancers. This     is a research study. The investigators do not know the best amount of special cells to use,     so different children will get different numbers of cells.      The purpose of this study is to learn the side effects and safe dosage of these special     cells. Participation in this study will last for 15 years.   "
120136|NCT01713426|"     This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in     patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of     these treatments and the duration of the study will be about 10 weeks (assuming that from     screening to treatment allocation takes 2 weeks). Participants will be asked to complete     questionnaires about various aspects relating to their condition throughout the study.      This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve     Injury or Non Diabetic peripheral polyneuropathy.   "
120137|NCT01713413|"     The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long     term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir,     the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.      The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to     the blood oxygenation during exercise testing. Given that the endurance time is very     sensitive for little changes in exercise capacity, this test will be used to show the     difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration     at 70% of peak Watt and oxygenation.      The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and     heart rate.   "
120138|NCT01713400|"     To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell     (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30     post-hematopoietic cell transplantation (HCT).   "
120139|NCT01713387|"     To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus S-1     combination therapy in patients with biliary tract cancer undergoing resection without major     hepatectomy   "
120143|NCT01713335|"     The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients.     Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide     bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess     Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be     included: Healthy smoker subjects, stable COPD patients and COPD patients with acute     exacerbation. Kallicrein levels in sputum will be compared in these groups.   "
120144|NCT01713322|"     Immunization procedures are a common source of iatrogenic pain for infants. A recently     developed clinical practice guideline, led by Taddio et al., created evidence-based     strategies for management of immunization pain. User-friendly educational tools outlining     these strategies were made. The goal of cluster randomized controlled trial is to assess     whether these educational materials increase utilization of pain-relieving strategies by     parents during infant immunizations.   "
120145|NCT01713309|"     This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically     ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a     prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients     with acute respiratory failure requiring intubation. In this substudy, the investigators     evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.   "
120146|NCT01713296|"     Investigators propose to study the single agent activity of pazopanib in a Phase II trial of     patients with relapsed or refractory small cell lung cancer. Because these patients have very     limited treatment options, use of an investigational agent in this patient population is     supported by current National Comprehensive Cancer Network guidelines. Using correlative     biologic studies to evaluate the anti angiogenic activity of pazopanib in the absence of     concomitant chemotherapy will allow us to delineate the responses due to this drug and the     effect on angiogenesis.      Pazopanib dose has been determined to 800 mg once daily per the initial recommended dose     approved by FDA and EMA, as monotherapy in advanced Renal Cell Carcinoma   "
120147|NCT01713283|"     This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir     (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV)     infection.   "
120148|NCT01713270|"     To study whether renal sympathetic denervation(RSD) is safe and effective in patients with     drug-resistant hypertension and symptomatic atrial fibrillation.   "
120149|NCT01713257|"     This study intends to investigate the clinical outcomes of a new immunoenhancing formula     which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU     patients.The study design is multicenter, double-blind randomized controlled study with 3     periods of Screening, Run-in and Randomization period.      Primary Objective: To evaluate the clinical outcomes of immunoenhancing diet (IED) arginine     free in medical-surgical ICU patients.      Secondary Objective: To evaluate the immunologic effects and safety of IED arginine free     formula.   "
120174|NCT01712919|"     The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation     against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and     efficacy of this new regimen.   "
120263|NCT01711762|"     This open-label, non-randomized study will assess the absorption, metabolism, and excretion     of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a     single dose of [14C]-GDC-0973.   "
120151|NCT01713231|"     -  Overall Objective: To test the hypothesis that oral vitamin D supplementation at higher          than currently prescribed doses has a beneficial effect on the skeleton of young          patients with osteogenesis imperfecta (OI).        -  Specific Aims: 1. To determine whether 12 months of high-dose vitamin D supplementation,          compared to standard-dose vitamin D supplementation, increases areal bone mineral          density z-scores at the lumbar spine. 2. To examine the effectiveness of high-dose          vitamin D supplementation to increase trabecular and cortical bone mineral density at          the radius. 3. To examine whether high-dose vitamin D supplementation has an effect on          physiological determinants of bone mass (parathyroid hormone, activity of bone          metabolism, muscle function).        -  Background: In a preliminary cross-sectional study of 282 OI patients we observed an          inverse relationship between serum 25-hydroxyvitamin D and parathyroid hormone levels          and a positive relationship between circulating levels of 25-hydroxyvitamin D and lumbar          spine areal bone mineral density z-scores. This suggested that high-dose vitamin D          supplementation would have a beneficial effect on bone density. Most OI patients          currently receive oral vitamin D supplementation of 400 International Units per day, but          doses of 2000 International Units per day are safe and have been shown to be beneficial          in studies on healthy adolescents.        -  Study Design: This is a parallel-group double-blind randomized controlled trial of 12          months duration on 60 children and adolescents aged 6 to 19 years with a clinical          diagnosis of OI. One group of 30 participants will be randomized to receive vitamin D3          at a dose of 2000 international units per day ('high-dose group'). The other group of 30          participants will be randomized to receive vitamin D3 at a dose of 400 international          units per day ('standard-dose group'). Randomization will be stratified according to          pubertal status and bisphosphonate treatment status.        -  Clinical Relevance: The proposed study aims at direct improvements in the care of OI          patients. If a simple and low-cost 'intervention' such as high-dose vitamin D          supplementation can be shown to be effective in relieving some of the disease burden          associated with OI, the benefit to OI patients worldwide would be substantial.   "
120152|NCT01713218|"     Pancreatic ductal adenocarcinoma (PDAC) has one of the worst prognoses of all human cancers     and is considered as a sanctuary, resistant to most of the drugs used. Identification of new     molecular targets involved in its pathogenesis is urgently needed and required both proper     and innovative efficacy assessment.      This proof-of-concept trial is studying the dynamic tumor response after the administration     of a short course (4 weeks) neoadjuvant combination of gemcitabine and a Hedgehog inhibitor     (Vismodegib) before surgery in patients with operable pancreatic cancer.   "
120153|NCT01713205|"     The purpose of this study is to evaluate a clinically and economically most effective     diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample     of severe trauma patients.   "
120154|NCT01713192|"     The purpose of this registry is to obtain perioperative data in patients undergoing cardiac     surgery and find out relations between the data and investigate several causes affecting     postoperative complications.   "
120155|NCT01713179|"     Ambroxol is a metabolite of bromhexine and possesses mucokinetic and secretolytic properties     that are also found in mucolytic agents.1 Ambroxol has been used for decades for the     treatment of respiratory disorders associated with excessive mucus, including chronic     inflammatory pulmonary conditions, bronchitis, and pneumonia.2,3 The drug changes the     biophysical properties of secretions by degrading the mucin polymers, deoxyribonucleic acid,     fibrin in airway secretions, and by generally decreasing viscosity.4 In addition, ambroxol     increases cyclic nucleotide (cAMP or cGMP),5 which can theoretically increase tear     secretion.6 Many systemic medications, such as antihistamines, antidepressants, diuretics,     acne drugs, and certain blood pressure medicines can cause or exacerbate a dry eye.7,8 On the     other hand, several topical medications, including mucolytics such as ambroxol and     bromhexine, may be used to treat tear-deficient dry eyes by promoting lacrimal gland     function.9 However, the effects of mucoactive agents on the tear film have not been     investigated systemically, and mucoactive agents may have a disturbing effect on the tear     film because they modify mucin.10,11 The tear film is composed of 3 unique layers, including     the outermost lipid layer, the middle aqueous layer, and the innermost mucus layer; this     structure enables it to perform many functions.12 The lipid layer acts as a barrier to     prevent tear film evaporation, and the aqueous layer supplies oxygen and important nutrients     to the cornea.13 The mucin layer, secreted mostly by conjunctival goblet cells, coats the     corneal surface rendering it hydrophilic, and anchors the tear film to the corneal surface.14     Deficiencies in the amount of tear production or alteration in tear composition can lead to     ocular surface disease.15 Although many studies have focused on aqueous-deficient dry eye     syndrome,16-18 the effect of mucin layer defects on the tear film has not been thoroughly     studied. Furthermore, very few reports have determined the effects of oral mucolytic agents     on the tear film and ocular surfaces, although a study has reported that filamentary     keratopathy was treated with debridement of filaments and application of topical mucolytic     agents such as acetylcysteine eyedrops. In the present study, we investigated the effects of     oral ambroxol on tear film and ocular surface.      Reference        1. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical update.          Expert Opin Drug Metab Toxicol 2008;4:1119-1129.        2. Rubin BK. Mucolytics, expectorants, and mucokinetic medications. Respir Care          2007;52:859-865.        3. Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respir Care          2007;52:1176-1193.        4. Gupta PR. Ambroxol - Resurgence of an old molecule as an anti-inflammatory agent in          chronic obstructive airway diseases. Lung India 2010;27:46-48.        5. Anfossi G, Russo I, Massucco P, et al. Adenosine increase human platelet levels of cGMP          through nitric oxide: possible role in its antiaggregating effect. Thromb Res          2002;105:71-78.        6. Gilbard JP, Rossi SR, Heyda KG, et al. Stimulation of tear secretion by topical agents          that increase cyclic nucleotide levels. Invest Ophthalmol Vis Sci 1990;31:1381-1388.        7. Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol          2009;3:405-412.        8. Terry MA. Dry eye in the elderly. Drugs Aging 2001;18:101-107.        9. Calonge M. The treatment of dry eye. Surv Ophthalmol 2001;45:227-239.       10. Yamada T, Takemura Y, Niisato N, et al. Action of N-acylated ambroxol derivatives on          secretion of chloride ions in human airway epithelia. Biochem Biophys Res Commun          2009;380:586-590.       11. Hasegawa I, Niisato N, Iwasaki Y, et al. Ambroxol-induced modification of ion transport          in human airway Calu-3 epithelia. Biochem Biophys Res Commun 2006;343:475-482.       12. Antti H, Tuulikki S, Matej O. Human tear fluid lipidome: from composition to function.          PLoS One 2011;6:e19553.       13. Ohashi Y, Dogru M, Tsubota K. Laboratory findings in tear fluid analysis. Clin Chim Acta          2006;396:17-28.       14. Davidson HJ, Kuonen VJ. The tear film and ocular mucins. Vet Ophthalmol 2004;7:71-77.       15. Bhavsar AS, Bhavsar SG, Jain SM. A review on recent advances in dry eye: pathogenesis          and management. Oman J Ophthalmol 2011;4:50-56.       16. Patel S, Farrell J, Blades KJ, et al. The value of a phenol red impregnated thread for          differentiating between the aqueous and non-aqueous deficient dry eye. Ophthalmic          Physiol Opt 1998;18:471-476.       17. Lin H, Li W, Dong N, et al. Changes in corneal epithelial layer inflammatory cells in          aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2010;51:122-128.       18. Yokoi N, Yamada H, Mizukusa Y, et al. Rheology of tear film lipid layer spread in normal          and aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2008;49:5319-5324.   "
120156|NCT01713166|"     The purpose of this study is to compare the effects of crystalloid and colloid, which are     used for pump priming solution, on the microcirculatory alterations during cardiac surgery.   "
122706|NCT01679847|"     The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier     penetration of the elemene.   "
120158|NCT01713140|"     Background:      Progressive strength training is a training modality used in rehabilitation after total knee     arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be     present in the operated leg after TKA, which relates to reduced central nervous system (CNS)     activation of the muscle. As increased CNS activation occurs during strength training when     muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this     also is the case after TKA. The clinical implication is that repetitions performed to     contraction failure during strength training, may help reduce CNS activation deficits of the     quadriceps muscle after TKA.      Purpose:      The aim of this study is to investigate CNS activation of the quadriceps muscle during     strength training performed with repetitions to contraction failure after TKA.      Method:      Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL),     semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions     performed in a knee extension machine until contraction failure. The relative loading will be     10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a     minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will     be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure,     etc.) of the set to failure.      Hypothesis:      Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA,     the EMG amplitude will increase while the median power frequency will decrease during a     strength training set performed to contraction failure after TKA.   "
120159|NCT01713127|"     The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during     ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants   "
120160|NCT01713114|"     The primary objective of this study is to assess the acute effects of different meals on     satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of     satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or     meal skipping conditions.   "
120161|NCT01713101|"     This study is to see whether the early intravenous administration of tranexamic acid improves     the outcome of acute upper gastrointestinal bleeding.   "
120162|NCT01713088|"     To evaluate whether Multisystemic Therapy (MST) is more effective in reducing youth offending     and out-of-home placement in a large, ethnically diverse, urban U.K. sample than an equally     comprehensive management protocol; to determine whether MST leads to broader improvements in     youth sociality and in mediators believed to be responsible for change in MST.   "
120163|NCT01713075|"     The purpose of the investigation is to confirm the safety and efficacy in long-term use of     Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the     post-marketing actual use.   "
120164|NCT01713062|"     The purpose of this randomised prospective multicenter longterm study is to evaluate the     survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked     polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip     Arthroplasty.   "
120165|NCT01713049|"     The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions     on mammograms and ultrasound.   "
120166|NCT01713036|"     This is a Phase 1, open-label, single centered trial to evaluate the mass balance,     bioavailability and metabolism of pimasertib in cancer subjects with locally advanced or     metastatic solid tumors.   "
120224|NCT01712269|"     The central aim of this research project is to determine how the ever-growing problem of     obesity in the western world contributes to the pathophysiology of obstructive sleep apnea     (OSA). To complete this aim, the investigators will determine the impact of obesity on the     mechanisms underlying OSA. This will be achieved by making physiological measurements of 4     physiological traits known to cause OSA as well as the patients sleep apnea severity, before     and after weight-loss surgery (i.e. bariatric surgery).   "
120167|NCT01713023|"     -  BACKGROUND: Individuals with diabetes report innate preference for sweet foods, possibly          due to genetic variants. In addition, studies have shown that ingestion of fructose          promotes lower postprandial blood glucose, compared to glucose. However, excessive          intake may increase triglycerides, uric acid and oxidative stress, due to oxidative          priority.        -  AIMS: To investigate the influence of fructose and glucose and taste receptor, type 1,          member 2 (TAS1R2) in glucose, triglycerides, uremia, oxidative stress, feelings related          to food intake and palatability of individuals with type 1 diabetes.        -  METHODS: The trial is a single-blind, two-way crossover (1-week washout) study in 30          subjects with type 1 diabetes. Blood samples were collected before and 2-hours after the          participants receive 75g of fructose or 75g of glucose dissolved in 200 ml water.          Capillary blood glucose were assessed at 30, 90, 120, and 180 minutes to determine          glucose, and visual analogue scales for measurement of appetite sensation were assessed          at 70, 120, and 190 minutes.        -  PURPOSE: The research proposal adds knowledge about the TAS1R2 (Ile191Val) polymorphism          and around the most suitable monosaccharide for individuals with diabetes type 1.   "
120168|NCT01713010|"     The purpose of this study is to evaluate physiological variables to the decision about the     appropriate time to discontinuation of mechanical ventilation in patients with traumatic     brain injury. It is expected that these variables are effective in predicting the outcome of     weaning from mechanical ventilation.   "
120169|NCT01712997|"     Previous studies suggest that combinations of existing therapies may be effective for     pulmonary arterial hypertension (PAH). However, all of these studies are sequential     combination therapy, for example, by adding sildenafil to previously prescribed bosentan.     This kind of therapy model is not enough for PAH patients, especially those with New York     Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the     investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin     analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH     by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in     6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and     time to clinical worsening.   "
120218|NCT01712347|"     This multicenter observational study will evaluate the efficacy and safety of first-line     bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants     with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has     decided to initiate first-line fluoropyrimidine based chemotherapy in combination with     bevacizumab will be observed for approximately 4 years.   "
120329|NCT01710891|"     Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard     laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be     randomized to have their first intubation attempt done using either standard laryngoscopy or     the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating     physician.   "
120170|NCT01712984|"     The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent     influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV)     containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent     influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2)     vaccines in producing protection against four strains of influenza virus.      Primary Objective:        -  To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination          inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is          non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28          days post-vaccination.      Secondary Objectives:        -  To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by          HAI GMTs and seroconversion rates) that is superior to the response induced by the          TIV-ID that does not contain the corresponding B strain.        -  To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.        -  To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64          years), race, ethnicity, gender, previous vaccination status, and baseline          seropositivity status.        -  To describe the safety profile for subjects who receive QIV-ID and TIV-ID.      Observational Objectives:        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or          Grade 3 solicited systemic reactions combined        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3          solicited injection site reactions combined.   "
120171|NCT01712971|"     The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or     peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an     important factor that determines the occurrence of postoperative complications. Therefore,     any significant reduction of intra-operative blood loss will benefit the peri-operative     course.   "
120172|NCT01712958|"     Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of     cancer-related death in the world. Despite potentially curative surgery and the use of modern     adjuvant chemotherapy, up to 40% of CRC patients subsequently develop local tumor relapse or     metastatic disease. Currently, aside from post-operative pathological staging, early follow     up of the patients does not include a specific test or any other evaluation that could     predict disease recurrence. Therefore, exploring and identifying novel biomarkers of CRC's     following diagnosis of the primary tumor may help us in identifying patients at high risk for     recurrence.      Modifications in signaling pathways and their regulation by microRNAs (miRNAs) are being     evaluated as biomarkers and therapeutic targets for cancer in general and CRC in particular.     It has been established, although not completely, that miRNAs have a role in initiation and     progression of CRC. Modifications of miRNAs have been recorded in CRC tumors, and the     expression patterns of these miRNAs could in principle biomark this cancer's phenotype. As     miRNAs are well documented to regulate critical molecules in signaling pathways, their     regulation of tumor relevant pathways may also serve to further sub-classify patients into     drug responsive groups. Moreover, miRNAs may be sampled from peripheral blood and are     available as a non-invasive diagnostic method, their application as biomarkers is of special     interest.      In this study the investigators aim to quantify miRNA levels in human colon and rectal     tumors, tumor adjacent and normal tissues. By comparing this data from a large cohort of     patients, the investigators aim to identify specific, relevant miRNAs that may serve as     biomarkers to stratify CRC patients according to their clinical characteristics such as     disease stage, specific treatment, prognosis and disease recurrence.   "
120173|NCT01712945|"     The purpose of this study is to test a novel strategy to prevent the clinical problem of     secondary autoimmunity following alemtuzumab treatment of multiple sclerosis.      The hypothesis is that autoimmunity after alemtuzumab can be prevented by giving a drug that     promotes thymic T cell regeneration (Palifermin, Kepivance®).   "
120175|NCT01712906|"     Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which     occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland     suppurative swelling and pain with fever. The pathological changes and harm caused by mumps     was not only confined to the parotid gland, on the contrary, the social harm caused by     serious complications cannot be ignored. As mumps is a vaccine-preventable infectious     disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13     genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain     of MuV in China was the F genotype. The commonly used vaccine strains represented only a     small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to     type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of     Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A     strain, which was the first separation and preparation of the attenuated mumps viruses in     China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the     cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much     safer to use. The preliminary test results showed that the vaccine possessed good     immunogenicity and good antigenic cross-reactivity. The application of this vaccine will     provide more effective means to prevent and control of mumps epidemic.   "
120176|NCT01712893|"     The present study is a randomized open-label -phase III study that aims to compare the     efficacy and safety of the adjuvant chemotherapy with simultaneous or sequential application     of Zoladex up to 2-3 years for ≤ 45 year old premenopausal hormone receptor-positive breast     cancer.   "
120177|NCT01712880|"     The purpose of this study is to determine the success rate of two treatments for infection     after total hip replacement: single stage arthroplasty exchange (your surgeon will take out     your original implants and replace them with a complete new set) compared to irrigation and     debridement with modular exchange (your surgeon will clean your implants with a surgical     solution and take out the plastic liner and replace it with a new one - the rest of your hip     implants will stay in place). The goal is to see if one is better than the other for the     treatment of hip infection after a total hip replacement. A successful treatment means that     you did not have to have another surgery on your hip for an infection-related reason.   "
120178|NCT01712867|"     The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol)     versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia     patients with fasting triglyceride levels ≥ 200 and < 500 mg/dL.   "
120330|NCT01710878|"     Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and     occlusive disease of the abdominal aorta.   "
134433|NCT01525212|"     The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid     (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype     1a and 1b HCV infected subjects   "
120179|NCT01712854|"     The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate     (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using     Optoelectronic Plethysmography (OEP). This study is unique as it will be the first     randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol     fumarate dihydrate as the intervention which will evaluate the effects on ventilatory     mechanics through the use of OEP. The investigators plan to demonstrate that     budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected     with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short     term on exercise capacity during a constant load exercise test. The changes in ventilatory     mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a     unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also     demonstrating the utility of OEP in evaluating of the effects of a medical treatment on     hyperinflation in individuals with chronic obstructive lung disease (COPD).        1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and          post exercise spirometry and evaluate exercise dynamic hyperinflation before and after          treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate          dihydrate will decrease dynamic hyperinflation as measured by OEP.        2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation,          specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical          breathing as measured by OEP.        3. Secondary Objective: Our secondary objective is to evaluate duration of steady state          exercise and exercise capacity before and after treatment. Our secondary hypothesis is          that decreases in dynamic hyperinflation during exercise will lead to improvements in          dyspnea with exercise, and allow for increases in exercise capacity.        4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady          state vs. Borg at end exercise.   "
120180|NCT01712841|"     Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in     developed countries and is often discussed in terms of the dry and the wet forms. The     wet form of AMD is the more advanced form of the disease and is responsible for 80% of the     legal blindness in AMD. Treatment options include a promising class of biologics called     anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery.     These therapies can slow further vision loss, but cannot achieve recovery of lost vision. The     wet form of AMD is always preceded by the dry form. Therefore, it is reasonable to expect     that the early detection and treatment of the dry form may help reduce vision loss or     progression to the more damaging wet form. Unfortunately, symptoms appear only in advanced     stages of the dry form. As light sensitive cells in the macula breakdown in a process     called geographic atrophy, the patient may notice blurred central vision.      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal     and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,     except that OCT measures the intensity of reflected light rather than acoustical waves.      This study aims is to use OCT technology to compare how the retinal anatomy and blood flow     differ within three severity groupings of non-exudative age-related macular degeneration     (NEAMD).   "
120181|NCT01712828|"     To find out if the blood level of lenalidomide can be changed when a drug that prevents     p-glycoprotein (a protein naturally present in the body that helps carry substances across     cell membranes that is found in many parts of the body like the intestines, liver, and     kidneys) from working (called a P-gp inhibitor) when taken together with lenalidomide. The     study is also trying to find out if blood level of temsirolimus can be changed when a subject     takes lenalidomide together with temsirolimus.   "
120182|NCT01712815|"     This phase I trial studies the side effects of positron emission tomography (PET)/computed     tomography (CT) in evaluating response to chemotherapy in patients with breast cancer.     Comparing results of diagnostic procedures done before, during, and after chemotherapy may     help doctors predict a patient's response to treatment and help plan the best treatment.   "
120183|NCT01712802|"     To establish evidence based guidelines for denture adhesives (powder and cream), multicenter     cross over randomized clinical trial will be carried out.      The null hypotheses are that there are no difference on improvement from baseline to post     application of two adhesives powder and cream, in terms of general satisfaction, oral related     quality of life, masticatory function and oral conditions.   "
120184|NCT01712789|"     The primary purpose of the study is to evaluate the safety and efficacy and to generate PK     and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients     with refractory or relapsed and refractory multiple myeloma.      The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment     phase and a Follow-up phase which starts within 28 days of discontinuation from study     treatment, every 3 months for up to 5 years.      In addition, the collection of steady-state PK data from a large population will enable     robust population PK and assess Pomalidomide exposure response analyses.      The exploratory objectives of the study are to investigate potential markers predictive of     POM response or resistance and pharmacodynamic markers.   "
120185|NCT01712776|"     To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in     decreasing the pain of venipuncture (blood draw)   "
120186|NCT01712763|"     The long acting GnRH antagonist degarelix will be tested for the treatment of women with     endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom     disappearance and disease free time during follow-up will be the outcomes for establishing     which medical treatment is the best in endometriosis recurrence treatment.   "
120187|NCT01712750|"     Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will     be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a     non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to     determine whether changes in VOT measurements occur in patients during cardiac surgery.   "
120188|NCT01712737|"     No studies have reported the effect of pre-meal snacking on raisins compared to other     commonly consumed snacks on energy intake in children. Therefore, the objective of the     current study was to examine appetite and energy intake following consumption of ad libitum     snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on     appetite and food intake 30 min later in 8 - 11 y old normal weight children. The     investigators hypothesized that raisins would lower subsequent energy intake in children and     reduce hunger.   "
120189|NCT01712724|"     Both aerobic training (AT) and resistance/strength training (RT) have the potential to     improve recovery after stroke. Research conducted in chronic disease and healthy populations     suggest that AT and RT combination therapy may produce synergistic and superior effects     along cognition and mobility domains, when compared to AT alone. However, the effects of a     combined training approach (AT+RT) compared to AT alone has not been investigated in people     post-stroke.   "
120190|NCT01712711|"     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat     content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)     index, and anthropometric measurements (body mass index and waist circumference)in diabetic     subjects with non-alcoholic fatty liver disease.   "
120191|NCT01712698|"     Acute changes in axial diffusivity will correlate with the severity of injury in patients     that suffer an acute spinal cord injury.   "
120192|NCT01712685|"     Background:      - The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor     tissue show up more clearly during scans. Researchers want to see how well it works for scans     for people who have kidney cancer.      Objectives:      - To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney     cancer.      Eligibility:      - Adults at least 18 years of age with kidney cancer that will be treated with surgery.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have two positron emission tomography (PET) scans of their kidneys.          They will have the scans before and after receiving an injection of 18F-VM4-037. The          scans will take about 2 hours to complete.        -  About 3 weeks after the PET scans, participants will provide tumor tissue samples from          their kidneys.        -  This is a scanning study only. Treatment will not be provided as part of this study.   "
120193|NCT01712672|"     Background:      - Dental plaque is a coating of bacteria on the teeth. It contributes to poor dental health     and diseases such as gingivitis, cavities and periodontal disease. Researchers who study     plaque know that many different types of oral bacteria stick to each other in test-tube     experiments. However, it is not clear if these interactions occur in natural dental plaque.     By studying how bacteria interact, researchers can better understand how bacteria come     together and grow to form plaque.      Objectives:      - To look at how bacteria interact with one another to form dental plaque.      Eligibility:      - Healthy nonsmoking volunteers at least 18 years of age.      Design:        -  Participants will be screened with a medical history and dental exam. They will also          have dental impressions taken for a stent (a device similar to Invisalign(SqrRoot)          braces).        -  Participants will wear the stent for up to 8 hours a day on selected study visit days.          It will contain enamel chips made from sterilized human teeth. The mouth bacteria will          stick to the chips and grow. Chips will be taken out of the stent twice during these          study visit days.        -  Participants will have other study visits to provide saliva and plaque samples. They          will also have gum swabs to collect bacteria.        -  Some participants may have a second set of study visits. At these visits, they will chew          gum to increase their saliva production. Afterwards, they will wear the stent with the          enamel chips for 4 hours. Samples from the stent will be taken once on these study visit          days.   "
120194|NCT01712659|"     Background:        -  The human T-cell leukemia virus 1 (HTLV-1 causes adult T-cell leukemia (ATL). Infection          does not immediately cause ATL, but it can develop over time. ATL is a rare and          aggressive type of cancer that disrupts the body s ability to control the HTLV-1 virus.          It also affects the growth and reproduction of cells infected with the virus.        -  Ruxolitinib is a drug that has been approved to treat bone marrow disorders. It can          interfere with the proteins that are important to the development and growth of ATL          cells. Drugs like ruxolitinib may be able to interrupt important activity in ATL cells.          Researchers want to see if ruxolitinib can be a safe and effective treatment for ATL.      Objectives:      - To test the safety and effectiveness of ruxolitinib for adult T-cell leukemia.      Eligibility:      - Individuals at least 18 years of age who have ATL caused by HTLV-1.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies will also be performed.        -  Participants will take ruxolitinib twice a day for 28 days. They will have blood tests          on days 1, 14, and 28. These tests will look at the levels of HTLV-1 in the blood.          Participants will have a final blood test about 2 weeks later. Treatment will also be          monitored with imaging studies.        -  Participants who have a partial response during treatment may be able to start taking          ruxolitinib again after the final blood test. They will continue to take ruxolitinib for          as long as it is effective and the side effects are not severe.        -  Participants who have a full response during treatment will take ruxolitinib for 56 more          days, and then stop treatment. If ATL returns, they may restart treatment and continue          it for as long as it is effective.   "
120195|NCT01712646|"     Background:      - Oxytocin is a chemical that the brain normally produces. It plays an important part in the     way humans and other animals act in social and emotional situations. Adults with     schizophrenia have been studied to see if oxytocin can reduce some symptoms of schizophrenia,     such as hearing voices, feeling suspicious, and not feeling interested in daily life. These     studies show that oxytocin may help. However, it has not been studied in children who develop     schizophrenia. Researchers want to see if oxytocin, given as a nasal spray, is safe and can     reduce schizophrenia symptoms in children.      Objectives:      - To see if an oxytocin nasal spray can reduce schizophrenia symptoms in children.      Eligibility:      - Children above 10 years of age who have childhood-onset schizophrenia, and have     schizophrenia symptoms in spite of taking medication.      Design:        -  This study will last 4 weeks. Participants will stay in the hospital for the entire          period of the study. Participants may also have an extra 2 weeks of study medication and          1 week of testing immediately following the initial 4 weeks.        -  Participants will be screened with a physical exam and medical and psychiatric history.          They will provide blood and urine samples, and have imaging studies of the brain. They          will also have tests to look at their social and emotional functioning. These tests will          take 1 week to perform.        -  Participants will have either oxytocin or placebo nasal spray twice daily for 2 weeks.        -  At the end of the 2-week period with nasal spray, there will be 1 week with no nasal          spray. All the tests of week 1 will be repeated.        -  The optional extra 3 weeks (2 weeks with oxytocin and one week for testing) will be          similar to the second, third, and fourth weeks of the study. All participants will have          oxytocin during this period.   "
120196|NCT01712633|"     Background:      - Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series     of pictures that can be used to look at how the brain processes information. It is used to     study problems with thinking, language, and movement, among other things. Researchers are     working to develop new and better fMRI techniques. To test these techniques, they want to     perform fMRI scans on healthy volunteers.      Objectives:      - To test different fMRI techniques in healthy volunteers.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have fMRI scans of the brain. During these scans, they will be asked          to perform simple tasks. These tasks may involve language, thinking, or motor skills.          The scanning sessions will last up to 2 hours.        -  Participants may be asked to return for additional fMRI scans over several years.   "
120219|NCT01712334|"     This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate     the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid     nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme     once daily chronically for at least 6 months will continue to receive Pulmozyme once daily     for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be     randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of     2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study     treatment is 6 weeks.   "
120220|NCT01712321|"     The purpose of this study is to determine whether Vilazodone is effective in the treatment of     symptoms of Social Anxiety Disorder among adults.   "
120221|NCT01712308|"     The goal of this clinical research study is to learn if sotatercept can help to control     MPN-associated myelofibrosis and anemia. The safety of this drug will also be studied.   "
120331|NCT01710865|"     The purpose of this study is to assess the effectiveness of a new hydrophilic sealant     (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials     (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.   "
120197|NCT01712620|"     Background:      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare     disorder. In spite of recent advances in treatment, the death rate remains unacceptably high.     Lung blood vessel function can be harmed by progressive injuries, such as inflammation,     leading to worsening of the disease. A drug called spironolactone has been known to improve     blood vessel function and reduce inflammation. Some people with PAH take spironolactone to     help treat fluid retention. However, its effect on inflammation and blood vessel function in     patients withPAH is not known. Researchers want to see if spironolactone can help these     conditions in people with PAH.      Objectives:      - To test the effectiveness of spironolactone in treating pulmonary arterial hypertension.      Eligibility:      - Individuals at least 18 years of age with pulmonary arterial hypertension.      Design:        -  This study will last for 24 weeks. Participants will be screened with a physical exam          and medical history. Blood and urine samples will be collected.        -  Participants will take either spironolactone or a placebo. They will take their study          drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests.        -  In Week 8, participants who have had no reaction to the treatment will receive a higher          dose of the drug or placebo.        -  In Week 12, participants will have a study visit with heart and lung function tests.          They will also have a 6-minute walk test, and provide blood and urine samples.        -  After additional study visits for blood samples, participants will have a final visit in          Week 24. The tests from Week 12 will be repeated at this visit.   "
120198|NCT01712607|"     Background and Objectives: All modern surgical procedures require a high level of cognitive     and psychomotor skills achieved using different training methods, but could be influenced by     fatigue and other psychological factors. We evaluate the effect of warm-up exercises on     operative laparoscopic performances in gynecologic laparoscopic procedures.      Methods: The surgical team operates on a consecutive series of 20 patients and perform     laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to     be operated on without warm-up exercises and group B to be operated on after a short-term     warm-up. All patients are operated on by the same surgical team. The full-time records of the     operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and     assessed by 2 independent observers using the generic OSATS rating scale. A training module     using the Lap Sim simulator was designed for the warm-up.   "
120225|NCT01712256|"     During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced     immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV     immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.      All patients participating in this trial have previously received the vacc-4x vaccine in     order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The     primary objective of this study is to evaluate if a re-boost with Vacc-4x could further     reduce the amount of HIV-1 virus and increase the immune response.   "
120226|NCT01712243|"     The purpose of this study is to determine whether specific wavelengths of light at night can     be used to improve mobile balance while simultaneously not increasing alertness.   "
122771|NCT01679002|"     To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of     BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to     assess the tolerability of such regimens in healthy subjects.   "
120199|NCT01712594|"     Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor     glucose readings when making their insulin dosage decisions. Designing a computerized system     that mimics the way insulin is produced naturally in a person who does not have type 1     diabetes holds many challenges; all of which cannot be addressed in just one study. The     purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a system     designed to automatically infuse the correct insulin dose during the hours that the patient     is sleeping.      The system consists of an insulin pump that provides insulin to the patient through an     infusion set. A sensor inserted just under the patient's skin measures glucose levels and a     transmitter sends this information to the pump. To enable the sensor to register the glucose     information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times     a day. In the commercially released system, the physician would recommend the continuous     background (basal) insulin rates and the patient would be required to make decisions     regarding extra insulin (bolus) for meals or as a response to high glucose levels.      In the Closed Loop System, a mobile control system is added to these devices. This consists     of an Android phone, a closed loop algorithm and a translator. This system is designed to     translate the sensor information and direct the pump to provide the required dosage of     insulin automatically without requiring input from the patient.      Reliable calibration has proved challenging, and so it is important that the system function     safely, even when calibration is inaccurate. In this study, a calibration error will be     introduced under very controlled circumstances. This testing will identify if the system can     maintain acceptable overnight glucose levels, regardless of whether or not calibration is     ideal.   "
120200|NCT01712581|"     T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial     tissue content (water, fibrosis, iron).      The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in     healthy volunters aged 18-69 years using 1.5T clinical MRI.   "
120201|NCT01712568|"     Study subjects were screened and enrolled for the study. Subjects were housed in the clinical     facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each     period. After maintaining at least 10 hours of overnight fast Test or Reference product was     administered orally (as per the randomization schedule) to each subject with about 240 mL of     water at ambient temperature in each period by trained study personnel.      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were     collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,     10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period     with a washout period of 7 days between the dosing of two periods. Subjects were continuously     monitored for well being i.e., blood pressure, radial pulse and oral temperature before     check-in, prior to drug administration and at regular intervals post dose in each period. The     concentration of Ropinirole in plasma samples obtained from study subjects was determined     using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on     obtained drug concentration data, using appropriate software.   "
120202|NCT01712555|"     After people lose an eye, for whatever reason, they often experience fat atrophy of the     tissues in the orbit. This leads to a sunken appearance that is often not correctable by a     cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/     invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own     disadvantages. This study seeks to demonstrate an improvement in the retention of injected     autologous fat by mixing in autologous PRP (platelet rich plasma).   "
120203|NCT01712542|"     Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma     patients.   "
120204|NCT01712529|"     The purpose of this study is to evaluate the effect of supervised physical exercise on     endothelial function and number of endothelial progenitor cells (EPCs) in patients with     systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise     on endothelium derived growth factor (VEGF) levels, disease activity, quality of life,     fatigue, perceived exertion and cardiopulmonary exercise test variables.   "
120205|NCT01712516|"     This study will assess the efficacy, safety and tolerability of indacaterol     maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.   "
120238|NCT01712087|"     This post-approval study will primarily evaluate the long-term safety of the MedStream     Programmable Infusion System when used in combination with Baclofen for the treatment of     severe spasticity. A secondary objective, to assess long-term effectiveness, based on the     observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm     Scores over the 36-month follow-up period will also be described.   "
120206|NCT01712503|"     This is a randomised controlled trial that formally compares intra-ocular lenses, which can     be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is     the newer toric lens which can correct astgimatism.      The null hypothesis is that both intra-ocular lenses give the same visual outcome in cataract     surgery. The alternative hypothesis is that the toric lens, provides a better unaided     (without glasses) vision, by correcting the participant's astigmatism.      It has been decided to conduct a randomised controlled trial of the two lenses, as although     the toric lenses are endorsed by many case series (which show a reduction in astigmatism),     they have not been formally compared to the standard lens. An RCT will enable the formal     comparison.      It is expected that this trial will take approximately a year to conduct: six months of     recruitment and six months of follow-up. A further six months will be required to analyse the     data and prepare a manuscript for publication.      The investigators do not plan to conduct an interim analysis or report as this is a     short-trial (six months follow-up) using two alternative lens that are CE marked and already     widely used.      Participants who have both cataract and astigmatism will be identified from the     GP/optometrist referral letter. They will be seen in specially designated clinics for this     research study, which will run alongside the routine cataract 'one' stop clinics at St     Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be     part of the study to have all the necessary examination done in one visit and for those who     decline participation to be seen in the regular cataract clinic. Potential participants will     be sent the research trial information (appendix A) with their appointment letter.      After introducing himself the researcher (who is also a senior cataract surgeon at Western     Sussex Hospital Trust), will check if potential participants have had the opportunity to read     the trial information that they were sent, or give participants a further copy as required.     The key points of the trial will be re-iterated by the researcher and they will be invited to     ask any questions about the trialThe researcher will check that the potential participant has     read and understood the participant information leaflet. They will answer any questions that     the potential participant has and will then take signed consent from those willing to     participate.      Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with     bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the     participant prefers, after consultation with the researcher or surgeon, to have operated     first. The participant will be allocated a unique study reference number.      Patients who decline to take part in the trial will be offered cataract surgery as per usual     WSHT/NHS procedure.   "
120207|NCT01712490|"     This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of     comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin     (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated     A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and     dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)   "
120227|NCT01712230|"     This study is designed to determine whether a reduction in hormones (such as occurs during     menopause) causes a decrease in calories burned during physical activity. This study will     also determine whether a reduction in hormones decreases calories burned while sleeping,     resting, and eating and whether an exercise intervention can prevent this.   "
120208|NCT01712477|"     This is a prospective randomized controlled pilot study in traumatic brain injury (TBI)     patients who are sedated with either propofol or midazolam to compare the cytokine response     and neuropsychological outcomes with and without elevated blood alcohol levels.      Sedation is part of the standard treatment in patients with a TBI and has been proposed as a     neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam     and propofol, are not standardized and it is unclear whether sedation has a significant     impact on recovery and outcome. A review of propofol versus midazolam in mechanically     ventilated patients shows evidence that both provide effective sedation but there is lack of     data to support one sedative over the other.      Cytokines are released in response to tissue injury and act to generate a variety of     physiologic responses. The cytokine elevation has been correlated with the extent of tissue     injury. This study will compare the cytokine distribution patterns at specific posttraumatic     time points in patients with a TBI sedated with either propofol or midazolam. Additional     analysis will compare the cytokine response in patients whom had elevated blood alcohol     levels with those with normal levels. Neuropsychological testing will also be performed to     determine the extent of brain injury and recovery.   "
120209|NCT01712464|"     This study aims to examine the modulation of neuronal and behavioural parameters of social     reinforcement learning.   "
120210|NCT01712451|"     Dose ranging study   "
120211|NCT01712438|"     Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated     patients with severe Hemophilia A.   "
120212|NCT01712425|"     The HIVconsv gene was constructed by assembling the 14 most conserved regions of the HIV-1     proteome into one chimaeric protein. This gene has been inserted into 2 leading     non-replicating vaccine vectors: an attenuated chimpanzee adenovirus serotype 63 (ChAdV63)     and a modified vaccinia virus Ankara (MVA) to construct the ChAdV63.HIVconsv and MVA.HIVconsv     HIV-1 candidate vaccines. The present study is named ChAd-MVA.HIVconsv-BCN01 and it is a     phase I, multicenter primary/booster therapeutic vaccination study to evaluate the safety and     immunogenicity of ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered intramuscularly     according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected individuals with     early viral suppression 6 months after initiation of Tenofovir/Emtricitabine plus     Raltegravir.   "
120213|NCT01712412|"     The objectives of this study are to determine the safety and efficacy of IW-9179 administered     to patients with functional dyspepsia (FD).   "
120214|NCT01712399|"     A clinical study to investigate the safety of mavrilimumab, an antibody being developed for     the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that     affects the joints.   "
120215|NCT01712386|"     Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced     exercise capacity. This is because their lungs are damaged and because of increased work of     breathing. In some patients, exercise capacity is reduced to such a level that even simple     activities of daily living, such as washing and dressing, may impose a challenge.      Recent findings in healthy young people suggest that increasing the amount of nitrate in our     diet in the form of beetroot juice can improve the ability to exercise. Studies involving     cycling have shown that less oxygen is needed to perform the same level of exercise after     taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be     converted in the body to nitric oxide (NO), a substance which increases blood flow and may     affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that     such dietary nitrate supplementation appears to reduce the amount of oxygen needed to     complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of     this study to see if such effects could be seen in COPD patients. If this is indeed the case,     then it may suggest that a period of dietary supplementation of a relatively cheap, widely     available, and natural food product may improve the ability of patients to undergo everyday     tasks and ultimately improve their quality of life.      To help investigators understand the effects of dietary nitrate supplementation on the     ability to exercise in COPD patients, the investigators will recruit 15 people with mild to     moderate disease. They will complete a series of undemanding exercise tests on three separate     occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading     up to the tests, and on the other occasion they will have had a course of beetroot juice with     the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and     nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow     us to assess any effects that may have occurred as a result of increased nitrate intake.   "
120216|NCT01712373|"     The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of     fatigue and Quality of Life of MS patients.   "
120217|NCT01712360|"     This study is being done to see how the body is affected when a study drug is applied to both     feet if the subject has athlete's foot or to both feet and the groin area if the subject has     both athlete's foot and jock itch. Safety of the drug and how well the drug works will also     be measured.   "
120312|NCT01711125|"     To explore the effectiveness and biobehavioural basis of baclofen in improving treatment     outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a     double-blind randomised placebo-controlled trial.   "
120222|NCT01712295|"     Plantar warts on the sole of the foot are among the most common warts seen in podiatry     clinics. Some patients are readily cured by simple standard of care treatments that include     wart debridement (trimming or excision) and application of 17% salicylate (commercially known     as Compound W)or by other treatments that may be painful and affect mobility. No treatment is     consistently effective and most patients fail treatment multiple times.      Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that     may improve the activity of salicylate in wart treatment by improving the ability to     penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may     improve cures of common foot plantar warts in subjects who also be receiving other     standard-of-care treatment.   "
120223|NCT01712282|"     Stroke is the leading cause of adult disability in Europe and United States and the second     leading cause of death worldwide and affects more than 10,000 Danes each year.      Studies in a late and stationary phase after stroke have shown that physical rehabilitation     is of great importance for survival and physical ability of these patients, however many     studies show that patients lie or sit next to their bed under hospitalization for more than     88.5 % of the daily hours. Physical activity in stroke patients has never previously been     measured immediately after debut of symptoms; furthermore there is no knowledge about the     optimal dose of physical rehabilitation for these patients.      Accelerometers, small measuring devices, are a relatively new way to measure physical     activity precisely, and hence it is possible to obtain an objective measure of how active     stroke patients are in the first week after admission. The accelerometers measure a variable     voltage, depending on the range and intensity of movement. They can measure movement     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.     Studies confirm their reliability, even in patients with abnormal gait, such as stroke     patients.      Another approach of studying the effects of physical activity and rehabilitation is through     the examination of biomarkers. Studies have shown that biomarkers released during physical     activity can inhibit biomarkers released after tissue injury in the brain, as seen after     stroke. These brain biomarkers cause further damage and studies show that the higher the     levels, the higher the damage. It is therefore obvious to examine whether physical activity     rehabilitation can down regulate this destructive process in patients with stroke.      Clarification of the optimal dose of physical activity in stroke patients immediately after     debut of symptoms and examination of both the biochemical aspects of physical rehabilitation     as well as the optimal dose of physical rehabilitation is of great importance for many     patients, their relatives as well as of a great socioeconomic importance.      The purpose of the project is to investigate feasibility of treadmill training on a     weight-bearing treadmill in the acute phase after admission after an ischemic stroke.     Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and     whether it changes with treadmill training.   "
120229|NCT01712204|"     Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to     mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the     inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis     of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β     inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target     for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis     with good safety record and very few contraindications to the co-morbidities commonly among     gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in     clinical trials. The favorable product profile of AC-201 overall provides a strong rationale     for investigating its clinical utility as prophylaxis against flares when initiating ULT.   "
120230|NCT01712191|"     This is a prospective, multi-center, open label, non-randomized study, evaluating the     treating of medial meniscus deficiency with the NUsurface Meniscus Implant.   "
120231|NCT01712178|"     A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for     pharmacodynamics, pharmacokinetics, and safety.   "
120232|NCT01712165|"     The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk     product) over a 12-week period increases red blood cell folate concentrations in women of     childbearing age in Singapore, compared to an equivalent amount of standard (unfortified)     milk.   "
120233|NCT01712152|"     Carriers of Duchenne muscular dystrophy (DMD) often have no severe symptoms of the scelet     muscles, but they may develop a poor heart function due to the involvement of the heart     muscle. Ultrasound of the heart is recommended, but it can detect a cardiac affection only     after the heart has already become weaker. Cardiac magnetic resonance tomography can detect     myocardial fibrosis already at preserved heart function and may facilitate early therapy. In     our study, diagnosed carriers of DMD will undergo examinations of the heart by blood tests,     EKG, heart ultrasound and magnetic resonance at enrollment and after one year in order to     assess the extent of cardiac affection and its association with the clinical development.   "
120234|NCT01712139|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.   "
120235|NCT01712126|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions   "
120236|NCT01712113|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Irbesartan 300 mg Tablets under fasted conditions   "
120237|NCT01712100|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Irbesartan 300 mg Tablets under fed conditions.   "
120239|NCT01712074|"     This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate     Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil.     The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered     the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and     neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor     re-emergence of neuropsychiatric and cognitive symptoms.   "
120240|NCT01712061|"     The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects     with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a     surrogate for improved glomerular filtration.   "
120241|NCT01712048|"     The aim of this study is to compare the efficacy and safety of two standard methods of     polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR)     and full water emersion (without submucosal injection) EMR, for large colorectal polyps.   "
120242|NCT01712035|"     Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic     white Americans. Neovascular AMD is an advanced form of macular degeneration that     historically has accounted for the majority of vision loss related to AMD. The presence of     choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.     Choroidal neovascular membranes consist of buds of neovascular tissue and accompanying     fibroblasts from the choroid perforating Bruch's membrane with extension either above or     below the retinal pigment epithelium. These neovascular complexes are associated with     hemorrhage, fluid exudation and fibrosis formation resulting in photoreceptor damage and     vision loss. Treatment of neovascular AMD consists of injecting inhibitors of vascular     endothelial growth factor (VEGF) into the vitreous cavity to interfere with proliferation of     choroidal neovascularization and to reduce vascular permeability.      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal     and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,     except that OCT measures the intensity of reflected light rather than acoustical waves.      This observational study will use OCT technology to study and compare the retinal and     choroidal anatomy and blood flow in two groups of patients with neovascular AMD: treatment     naïve group and active treatment group.      The purpose of this study is to assess the utility of OCT angiography in the evaluation of     NVAMD.   "
120243|NCT01712022|"     Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of     the study is to evaluate the accuracy and repeatability of the epithelial thickness     measurement. Consented subjects will undergo a series of cornea measurements using optical     coherence tomography (OCT) that will be used for analysis.   "
120244|NCT01712009|"     The primary objective of the study is to estimate the difference in bone pain between breast     cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic     intervention, prophylactic naproxen, or prophylactic loratadine.   "
120245|NCT01711996|"     Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be     related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction     (UPJO) patients. We are trying to analyze whether it is related with the grade of renal     injury in UPJO patients.   "
120246|NCT01711983|"     The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and     efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum     atrial septal defects (ASDs). The data obtained in this study will evaluate this next     generation device as compared to outcomes of prior studies conducted with the GORE® HELEX®     Septal Occluder.   "
120248|NCT01711957|"     Recent experimental and clinical studies have shown that platelets play a critical role in     liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious     condition in liver transplantation (LT) recipients, was shown to be associated with     postoperative morbidity and mortality after partial hepatectomy.      The investigators aim at evaluating whether postoperative low platelet counts are indicators     of short- and long-term outcomes after liver transplantation.   "
120249|NCT01711944|"     Parents of children newly diagnosed with cancer experience depression and anxiety, especially     in the first several months of treatment. Bright IDEAS, an 8-session problem-solving skills     training (PSST) program has been used in studies with more than 900 mothers including more     than 125 monolingual Spanish-speaking mothers. It has been shown to significantly decrease     mothers' distress and to particularly benefit Latina immigrants. This past spring, the     NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program and has included it     in the National Registry of Evidence-based Programs and Practices. To date, Bright IDEAS has     been available to mothers at only a few cancer centers with specially trained personnel. This     proposal is designed to bring Bright IDEAS on-line to make it available to mothers and     fathers 24/7 anywhere with Internet access. The investigators will carefully analyze     acceptability and use to gain insight into the most promising ways of disseminating     interventions like Bright IDEAS using Internet, Internet II, and other emerging technologies.   "
120250|NCT01711931|"     The purpose of this study is to compare the efficacy and safety of everolimus- and     biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.      The null hypothesis to be rejected is that there is no significant difference with regard to     lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR     at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting     bioresorbable vascular scaffold stents.   "
120251|NCT01711918|"     To provide oral domperidone to patients between the ages of 18 and 60 years of age, according     to the investigator's judgment, a prokinetic effect is needed for the relief of severe     gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying     scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal     pain. We will recruit patients for two years and the patients will be given domperidone for     up to two years.   "
120252|NCT01711905|"     The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day     for 12 weeks can be used to normalize vitamin d-Status   "
120253|NCT01711892|"     Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced     Prostate Cancer (PC).      The musculoskeletal toxicity associated with ADT is well established, leading to a decrease     in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk     of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.      Numerous studies have shown an association between physical activity, physical capacity and     quality of life in cancer patients and recent epidemiological research suggest that regular,     moderate-intensity physical activity may have a positive effect on survival in men with     prostate cancer.      Within exercise physiology there is new evidence pointing to recreational soccer as a unique     form of intermittent exercise that effectively stimulates aerobic and anaerobic energy     delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular     adaptations of importance for health.      It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week     will improve the health profile of PC patients receiving ADT treatment.   "
120254|NCT01711879|"     This 52 week study will assess the use of intravitreal aflibercept injections in patients     with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.      The investigators hypothesize that the neovascularization of the iris and angle present in     neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept     injection alone and result in increased comfort and preservation of visual field as compared     to current standard of care utilizing pan-retinal photocoagulation. The advantages to     intravitreal aflibercept injection use could include resolution of NVI/NVA     (neovascularization of the iris/neovascularization of the angle) leading to quicker pain     relief and quicker lowering of IOP (intraocular pressure).   "
120255|NCT01711866|"     The purpose of this study is to assess the safety and feasibility of switching subjects with     advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess     the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects     switched from previous treatment with either Pramipexole or Ropinirole.   "
120256|NCT01711853|"     The study to be conducted is a prospective, open label trial. It is designed to evaluate the     pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate     in patients with chronic kidney disease.   "
120257|NCT01711840|"     The purpose of the investigation is to confirm the safety of patients receiving Symbicort     Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing     actual use.   "
120258|NCT01711827|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of prednisolone after single dose administration of prednisone. This study     will also assess the safety and tolerability of isavuconazole alone and in combination with     prednisone.   "
120259|NCT01711814|"     The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in     subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA     study.   "
120260|NCT01711801|"     This randomized, Investigator/Subject-blind, adaptive single-ascending-dose,     placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics     (including the effect of food), and pharmacodynamics of RO5545965 following oral     administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts     to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2     doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period     of approximately 2 weeks between treatment periods.   "
120261|NCT01711788|"     The purpose of this study is to determine if the method of intrabone infusion of hematologic     stem cells can increase and accelerate hematopoietic reconstitution after umbilical cord     blood transplantation in pediatric patients.   "
120264|NCT01711749|"     This is an open-label, randomized, two treatment, two sequences, two periods crossover study,     using a crossover 2x2 design, where each subject will be randomly assigned to reference or     test formulation, in order to evaluate if both formulations are bioequivalent.   "
120265|NCT01711736|"     The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of     the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed     vaccine Fluarix® (TIV) in young children 6 to 35 months of age.   "
120266|NCT01711723|"     In accordance with the recently revised FDA draft renal impairment guidance (March 2010)     which advises the conduct of renal impairment study in drugs that are not predominately     eliminated through the renal route, the proposed study will be conducted to formally assess     the pharmacokinetics (PK) of darapladib in severely renally impaired subjects.      In this is an open-label, non-randomized study eight subjects with severe renal impairment     will be recruited along with 8 healthy control subjects matched to the severe renal     impairment subjects based on gender, body mass index (plus or minus 20%) and age (plus or     minus 10 years).      All subjects will receive repeat oral doses of darapladib 160 milligram (mg) for 10     consecutive days. The pharmacokinetics of darapladib and its metabolites; and safety and     tolerability will be evaluated.      All the subjects will be admitted to the clinic on the evening of Day -1. Subjects may check     out of the clinic on Day 2 after all assessments are complete, but must return to the clinic     each day (Days 3-8) for dosing and assessments. Subjects will be admitted to the clinic again     on the evening of Day 9. After the last dose of the study drug, there will be a follow-up     period which will include 2 visits (Day 20-24 and Day 38-52). The total study duration for     each subject including the screening, treatment and follow-up periods will be approximately     11 weeks.   "
120267|NCT01711710|"     The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled     Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or     augmentation   "
120268|NCT01711697|"     This phase I trial studies the best dose of radiation therapy in treating patients with     locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation     therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as     stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly     to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been     shown to provide excellent results when used in early stage lung cancer, but has not yet been     applied to patients with more advanced disease.   "
120269|NCT01711684|"     Melanoma is a life-threatening cancer which poses a significant health burden, especially     when metastatic or spreading to areas other than the original tumor growth. Although various     treatment options are currently available for melanoma, melanomas that have metastasized     widely to the skin pose a significant clinical challenge as the available therapies have     limited effect. This study proposes the use of a topically applied compound named     diphenylcyclopropenone (DPCP) which has been shown to be effective in treating melanoma     patients whose diseases have spread widely throughout the skin. DPCP works by having a     patient's own immune system, which is usually used to fight infections, attack cancerous     cells. This compound has commonly been used to treat other conditions such as warts and hair     loss throughout the world for many years and is known to cause limited side effects. Altering     a patient's own immune system through topical treatments has also been shown to benefit     patients with other cancers that have metastasized to skin such as breast cancer. In this     study, the investigators will use DPCP to treat cutaneous metastases of various cancers     including melanoma. Our overall intention is to get a better understanding of effective     immune responses in the skin that may mediate metastatic cancer regression or cure.   "
120270|NCT01711671|"     A study to evaluate the safety, efficacy and bone changes with combination therapy of     intravenous (IV) infused DKN-01 and lenalidomide/dexamethasone, versus lenalidomide and     dexamethasone in relapsed or refractory multiple myeloma (MM) patients   "
120271|NCT01711658|"     PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of     radiation therapy plus cisplatin in patients who have head and neck cancer that is not     related to the HPV virus.   "
120272|NCT01711645|"     Monitoring immune response and longevity in serum and milk after Tdap administration to     postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just     delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at     Vanderbilt University Medical Center. The enrollment period will be fifteen months. The     duration is over two years of observation.   "
120273|NCT01711632|"     The purpose of this study is to find out what effects, good and/or bad, treatment with     vemurafenib (also known as Zelboraf™) has on the patient and on leukemia. Specifically, the     researchers want to know how well vemurafenib eliminates leukemia from the blood.   "
120274|NCT01711619|"     The purpose of this study is to compare the effectiveness of peripheral nerve stimulation     utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM)     versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome     (FBSS).   "
120275|NCT01711606|"     This prospective observational study (registry) on Fragile X syndrome (FXS) is designed to     evaluate characteristics, management and patient and caregiver-related outcomes the quality     of life of Families and patients with FXS and to collect epidemiological and health economic     data.        -  EXPLAIN will report current and comprehensive data onEpidemiology data on fragile X          syndrome        -  Characterisation of the phenotype of FXS patients        -  Description of patient characteristics (demographics, family history, comorbidity,          education, working situations, care situations, insurance status)        -  Documentation of therapeutic interventions        -  Recording and assessment of psychosocial parameters (possibly also inclusion of family          members, carers)        -  quality of life of the carer and if possible the patient        -  Health economic parameters and consumption of resources   "
120286|NCT01711463|"     In this study, fluticasone furoate (FF) and vilanterol (VI) in different dose combinations     (50/25mcg, 100/25mcg and 200/25mcg) will be administered from a single dry powder device to     evaluate the PD, PK, safety and tolerability of the combination in healthy Chinese subjects.     The information gathered will be used as a support of the clinical development program of the     fixed dose combination of FF/VI inhalation powder in Chinese population.   "
120276|NCT01711593|"     Despite advances in medications, allergic diseases, including allergic asthma continue to     rise in prevalence. For this reason, there is a need for a better understanding of the     mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The     investigators hypothesize that much remains to be learned about the behavior of T effector     and T regulatory cells in allergic disease. Furthermore, the investigators hypothesize that     novel mechanisms of allergic tolerance may exist, and elucidation of these mechanisms may     provide insights into novel therapeutic strategies to control allergic diseases. The     investigators will investigate the capacity for T cell tolerance induction in allergic     subjects by a novel type of immune tolerizing dendritic cell (it-DC). The investigators will     assess whether in vitro generated it-DCs have the capacity to induce antigen-specific T     regulatory cells and suppress allergen-specific T effector cell function in vitro.      Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes in     the airways that occur during exposure to allergen. For this investigation, the route of     administration will be topical application of the titrated allergen to a bronchoscopically     isolated subsegment of one lobe of one lung. The dose of biologic will be determined from     prior skin-prick testing.   "
120277|NCT01711580|"     Patients with a high grade glioma have an increasing overall survival and progression free     survival after initial treatment. Because of a better performance status these patients are     more often eligible for re-treatment with for example radiotherapy. However, to date only a     few prospective studies on re-irradiation of gliomas exist and very little is known about the     effects of re-irradiation on quality of life and cognition. This trial is designed to     longitudinally establish the effects of re-irradiation on quality of life, cognition and     physical performance in patients with a high grade glioma. Based on the currently available     information the investigators hypothesize that quality of life after re-irradiation can be     kept stable until further tumour progression.   "
120313|NCT01711112|"     Based on the previous clinical experience in other cancers, and considering the absence of     current standard salvage regimens, the single agent docetaxel is selected as the regimen for     this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe     myelosuppression observed in other cancer trials warrants further study in urothelial cancer.     The objective of the study is to evaluate the safety and activity of weekly docetaxel given     as salvage therapy for advanced urothelial cancer.   "
120278|NCT01711567|"     Entecavir, a potent antiviral agent, has been widely used for treatment-naïve chronic     hepatitis B patients. However, about 20% of patients showed partial virologic response after     2 year of entecavir therapy (33% in HBeAg positive, 10% in HBeAg negative patients).     Tenofovir is a nucleotide analogue with more potent antiviral activity. In addition, there is     no cross resistance between the two drugs. Therefore it is assumed that tenofovir would be     effective in the treatment of chronic hepatitis B patients who shows partial virologic     response (detectable HBV DNA by real time PCR after 12 months of treatment) despite treatment     with entecavir. In this study, we will compare the efficacy of switching to tenofovir with     continuing entecavir in patients who shows partial virologic response to entecavir.   "
120279|NCT01711554|"     This phase I trial studies the side effects and best dose of lenalidomide when given together     with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma     that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as     lenalidomide and isotretinoin, work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Monoclonal antibodies, such as dinutuximab, may interfere with the ability of     tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together     with dinutuximab therapy may kill more tumor cells.   "
120280|NCT01711541|"     This partially randomized phase I/II trial studies the side effects and best dose of     veliparib when given together with combination chemotherapy and to see how well they work in     treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as     docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether combination chemotherapy is more     effective when given with or without veliparib in treating head and neck cancer.   "
120281|NCT01711528|"     This phase I trial studies the side effects and best dose of dinaciclib and bortezomib when     given together with dexamethasone in treating patients with multiple myeloma that has     returned after a period of improvement. Dinaciclib and bortezomib may stop the growth of     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving dinaciclib and bortezomib together with dexamethasone may kill more cancer     cells.   "
120283|NCT01711502|"     This is a multicenter, national, retrospective chart-review study that will be based on the     collection of data from electronical or paper-based medical records with available data on     female patients diagnosed with metastatic brest cancer . The main purpose of this study is to     provide accurate, evidence based description on the incidence of progression of metastatic     breast cancer and its clinical management.   "
120284|NCT01711489|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety     and tolerability of isavuconazole will be assessed alone and in combination with MMF.   "
120285|NCT01711476|"     The objective of this study is to investigate the effects of two isocaloric maintenance diets     with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome     P450c17 alpha activity in lean PCOS women.      The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist     in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high     calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to     OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.   "
120287|NCT01711450|"     This study is aimed at assessing whether performing a paravertebral block (a type of regional     pain relief) can reduce the pain and anxiety patients experience during radiological     procedures on the liver.   "
120290|NCT01711411|"     The study will measure the incidence of moderate and severe adverse events (AEs) associated     with PrePex procedures, including both procedural and post-procedure events, and all     device-related incidents such as dislodgment. To assure complete ascertainment of AEs,     study-specific forms will be used to collect standardized data from the circumcision visit     and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will     revert to routine practice (two follow-up visits) for the remaining 375 cases.   "
120314|NCT01711099|"     Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial     Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial     ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina     pectoris.   "
120291|NCT01711398|"     The experimental plan will consist in:      The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the     optimal and recommended dose of IPP-204106N using a Bayesian with memory design with     combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of     three patients. The Bayesian methodology allows updating information as the trial progresses     and stopping the trial as soon as the information obtained is deemed to be sufficient.     Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I     clinical trial with N6L will be used to inform the prior distribution in the present study.      The decisional part, according to the results of the phase I portion of the study, will     define the optimal dose recommended for the phase IIa portion of the study.      The phase IIa portion of the study will confirm the optimal dose, and is designed to evaluate     the safety and the preliminary efficacy of IPP-204106N in an expanded patient population     treated at the recommended dose of IPP-204106N.   "
120292|NCT01711385|"     In an ongoing study new dental patients are screened to determine their risk of having     undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and     signs of gum disease. Investigators further seek to assess if a post-identification     intervention leads to a greater likelihood of study participants identified as potentially     pre-diabetic or diabetic visiting their physician regarding their screening blood test     results, and to improved health outcomes.   "
120293|NCT01711372|"     Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and     provide little information about accessory movements in response to a stimulus. One in ten     children, ages 5 to 17, has been diagnosed with ADHD.      Tests such as the Conners' Rating Scale require subjective responses from parents and     teachers, making coordination difficult. The computerized Conners' Continuous Performance     Test (CPT) provides objective data in regards to inattention and impulsive patterns of     response. However, it does not provide data regarding accessory movements such as     restlessness, hyperactivity, and other inappropriate movements. If the subject taking the     exam has a reading disorder, it will impair his or her ability to respond accurately and it     will increase response time. The T.O.V.A. is another computer based test used as a diagnostic     aid for ADHD, which uses a microswitch to record responses. It does utilize auditory and     visual stimuli, which removes the reading level limitation. However, it is unable to measure     to measure accessory movements that may be contributing to reaction time and errors of     omission and commission.      Because of these limitations, a new company called CogCubed has created a new game based on     the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are     unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with     one another. CogCubed is providing the data for this study. The game will be played in a 30     minute sessions by subjects ages 6-17. Subjects recruited to play the game will be those with     ADHD and those without, matched by gender and age. Those with comorbidities of developmental     delay, mental retardation, psychosis, schizophrenia, bipolar disorder and substance use     disorders will be excluded, as well as any physiological disability that affects upper limb     movement and/or coordination. Informed consent will be obtained from parents and patient     prior to administering the game. Parents will fill out a Conner's Brief Rating Scale and a     Conner's Brief Rating Scale, Teacher's version will also be supplied to be filled out at     school.      The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo     for which a game was created, which uses auditory and visual stimuli and distracters, the     investigators expect that they will be able to provide a more accurate profile of impulsivity     and inattention. The investigators expect that inattention will have more errors of omission     and less tilt movements than control and impulsivity will be represented as more commission     and greater tilting movements than control. This trial builds on the previous results of our     phase 1 trials used to create the predictive algorithms to analyze the data and predict the     likelihood of ADHD diagnosis based on patterns of game play behavior.   "
120294|NCT01711359|"     The purpose of this study is to determine whether baricitinib therapy alone is noninferior to     methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid     arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other     conventional or biologic disease-modifying antirheumatic drugs (DMARDs).   "
120295|NCT01711346|"     The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells     (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs     prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to     conventional untreated RBCs stored for 35 days.   "
120296|NCT01711333|"     This study is to evaluate symptomatic changes and safety before and after the administration     of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with     peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD).   "
120297|NCT01711320|"     In this study, investigators hypothesized that the plasma concentration of metformin and its     glucose-lowering action would be affected by omeprazole, probably by altering the expression     or function of OCTs in the liver, its primary target organ, as well as in the kidney.   "
120298|NCT01711307|"     The proposed trial is a multi-centre prospective randomized controlled trial comparing     outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or     with open operative tendon repair. All patients will undergo accelerated functional     rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.   "
120299|NCT01711294|"     To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic     cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard     diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of     mucinous (pre-malignant) and non-mucinous cysts.   "
120300|NCT01711281|"     Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major     cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for     synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters,     physical capacity and quality of life. A continuous measurement of the left-ventricular     volume would provide information about heart performance and could be used for both heart     failure monitoring and optimization of CRT-therapy.   "
120361|NCT01710462|"     This superiority phase III study to compare the combination of Pantoprazole and Domperidone     with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The     hypothesis is that combination of the two medication at the unique capsule is better to the     patients because decrease the quantity of times the patients need to take medicines during     the day.   "
120301|NCT01711268|"     Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is     50mg, but many patients require a dose decrease due to side-effects. Drug levels of sunitinib     vary approximately 10-fold between patients.      This study will measure blood levels of sunitinib and its metabolite, and correlate these     with side-effects and the response to the treatment. The study aims to establish whether     blood levels change with time, and see how useful blood levels are for monitoring patients     treated with sunitinib.   "
120302|NCT01711255|"     Recent research in multiple sclerosis (MS) have suggested that altered coagulation and     vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic     method of analyzing clot formation. This instrument will be used to compare coagulation in     individuals with MS to healthy controls. A 24-hour dietary recall and food frequency     questionnaire will help determine whether coagulation is modified by fish consumption.   "
120303|NCT01711242|"     The objective of the trial is to compare disease-free survival between adjuvant XELOX alone     vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer     patients with D2 dissection.   "
120304|NCT01711229|"     Acetaminophen (Tylenol) is a drug that is used commonly for relief of mild to moderate pain.     It is found in many pain medicines that people take after having surgery. Narcotics are other     drugs also used for pain (examples of narcotics are morphine and related pain medications).     Medical science knows for a fact that acetaminophen works well when taken with narcotics for     moderate to severe pain. Recently, acetaminophen has become available in an intravenous (IV)     form called Ofirmev®. The IV form means that acetaminophen can be given into a vein. The     benefits of getting medicine from an IV include:        -  making the medicine work quickly        -  less medicine having to pass through the liver to be changed into a form that your body          can process The investigators know that acetaminophen is helpful for pain relief at the          time of surgery and after surgery. Acetaminophen is a very popular drug in outpatient          surgery for pain control when patients go home. The patient's surgeon uses it to control          pain after surgery at home in the form of Lortab or Percocet (Lortab and Percocet also          have a narcotic medicine that mixes with acetaminophen). Also, currently at Surgicare,          some anesthesiologists give intravenous acetaminophen while the patient is waiting to go          to surgery. The investigators currently do not give any patient acetaminophen by mouth          BEFORE surgery. However, since the addition of the IV form to the drug market, there has          been interest to see if the oral form is just as good or better in reducing pain after          surgery. This is why we are asking patients to join our study. The goal of this study is          to find out if the oral form (by mouth) or the IV form (given into a vein) of          acetaminophen controls pain after surgery better.   "
120305|NCT01711216|"     Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan     and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for     management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles,     dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage,     infertility due to luteal insufficiency, as well as part of hormone replacement therapy.     There are limited data regarding dydrogesterone's role in achieving cycle regularization from     post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in     a post-marketing setting after cessation of treatment and whether the persistence, if any, is     related to the duration of dydrogesterone therapy. Hence, in this observational program, the     goal is to observe the possible implications of such treatment in terms of treatment length     and response pattern.   "
120306|NCT01711203|"     Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a     multimodal strengthening program, for patients under the age of 21, who have spondylolysis     and/or spondylolisthesis.      Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in     children and adolescents presenting with low back pain.      A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with     functional performance test measures, exercise logs, adherence scale for patient and parent     perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry     Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will be     randomized into two groups: bracing and a general strengthening program vs. bracing and a     Pilates/motor learning program combined with a general strengthening program.      This study will begin with an initial examination and continue with treatment sessions     2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing     the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome     measures.   "
120307|NCT01711190|"     The aim of this project:        1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and          intracameral administration of bevacizumab.        2. Medium-term follow up (6 months) of the induced corneal astigmatism.        3. Investigating correlations between postoperative astigmatism, particularly with the          postoperative IOP.   "
120308|NCT01711177|"     Glaucoma is the second leading cause of blindness among seniors in Canada. It is often     associated with an elevated intraocular pressure (IOP), but its exact mechanism is still     largely unknown. Some studies have shown a link between glaucoma and changes in the amount of     oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular     veins among three different groups using a spectrophotometer. This instrument is linked to a     camera and can measure the quantity of oxygen in the veins using different characteristics of     the blood inside.      The groups of the study are: patients without glaucoma, patients suspected of glaucoma and     patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost     0.004%, will only be administered to the groups suspected or diagnosed with glaucoma.     Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten     patients will be recruited into each group for a total of 30 patients in this study. All     patients for the suspected or diagnosed groups will be recruited from the Jewish General     Hospital. Subsequently all testing will be done at the École d'optométrie, Université de     Montréal   "
120362|NCT01710449|"     An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal     controls. Each subject will receive PFP as a contrast agent to visualize the airway and     alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures.   "
120309|NCT01711164|"     Viral hepatitis is a serious world health problem affecting over 1 billion people worldwide.     Presently the lack of highly effective treatments results in many patients requiring liver     transplantation or death. The investigators have defined the role of a unique molecule FGL2     and its receptor fc-gammaR and its role in the pathogenesis of both experimental and human     hepatitis. The studies proposed in the present proposal will test the hypothesis that     measuring levels of fgl2 in plasma will identify individuals that will go on to develop     chronic disease and inhibition of binding of fgl2 to its receptor will allow the host with     both acute and chronic disease to develop an appropriate immune response and clear the virus.     The studies will provide rationale for generation of new therapies to improve the treatment     of patients with acute and chronic viral hepatitis by targeting fgl2.   "
120310|NCT01711151|"     1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how          this varies between subgroups of ILD.        2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered          breathing within ILD patient population.        3. To assess the economic impact of ILD.        4. To understand how self-aware ILD patients are regarding their treatment/management.        5. To compare the demographic details, including smoking status and occupational history,          of patients with interstitial lung disease   "
120311|NCT01711138|"     The purpose of this study is to evaluate if changes to the built environment influence     physical activity and active transport to school in children and youth.   "
120315|NCT01711086|"     Double-blind study, randomized, controlled, and crossover. Study recruited 30 volunteers with     stable asthma aged 8-18 years. Participants will perform lung function as part of the routine     follow-up then will receive a Foradil 12mcg either with an Aerolizer (a standard dry powder     inhaler) or with the Inspiromatic (an active, breath synchronized innovative inhaler). 3-60     days later participants will receive the same drug through the other inhaler.      Pre and post treatment (15 min, 30 min, 60 min) Lung function results, drug levels in the     blood, vital signs and side effects will be recorded.   "
120316|NCT01711073|"     A phase I trial to study the safety of mobilization of stem cells with G-CSF and Mozobil in     patients with chronic liver disease.   "
120317|NCT01711060|"     Increasing cesarean rate in France is worrying. Different methods are described for ripening     labor : the use of prostaglandins is described but maybe dangerous for patients with scarred     uterus and is not recommended.      Intracervical balloon is an efficient alternative methods which as already been tested for     unfavorable cervix ripening on nulliparous women.      But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score     <4).      The investigators propose a prospective randomised trial comparing cervix ripening with     intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin     (reference method).      The investigators expect to demonstrate what it's a safe method to increase vaginal delivery     for women with previous cesarean section who need an induction of labour.   "
120318|NCT01711047|"     The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly     defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation     in addition to pulmonary vein isolation and linear ablations improves single procedural     success rate over a 12 month follow up period.   "
120319|NCT01711034|"     The primary objective of this study is to determine the safe and tolerable dose level of     OPB-111077 for patients with advanced cancer.   "
120320|NCT01711021|"     This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the     treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.   "
120321|NCT01711008|"     Both regular exercise and breakfast consumption have well known health benefits. Consuming     breakfast prior to morning exercise may influence appetite, mood and cognitive function later     in the day. The purpose of this study is to test whether the amount of food consumed at     breakfast prior to exercise influences these parameters in active women.   "
120322|NCT01710995|"     The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder     and Losec 20mg capsules in healthy volunteers under fasting conditions.   "
120323|NCT01710982|"     A study to evaluate the safety of TZP-101 in comparison with placebo when administered     post-operatively in patients who have undergone partial bowel resection.   "
120324|NCT01710969|"     The planned study will randomly assign aggressive children to one of two versions of the     Coping Power child component. The two versions of Coping Power will either deliver the child     component of the program in the usual small group format (Group Coping Power: GCP) or in a     newly-developed individual format (Individual Coping Power: ICP). By providing a direct     comparison of two different formats of the same intervention, the planned study's design will     fill a critical gap in our current understanding of the relative effectiveness of group vs.     individual programs. Further, this study will allow for examination of the specific factors     that influence relative effectiveness of these two formats, important information with broad     implications for program development, training of clinicians, and intervention     implementation.   "
120325|NCT01710943|"     The proposed study involves developing and evaluating an interactive, web-based CBT     intervention for OEF/OIF Veterans with hazardous or problematic substance use and PTSD     symptoms (PTSD or subsyndromal PTSD). The intervention will address the special culture and     experiences of the investigators targeted population (OEF/OIF Veterans). The web-based CBT     intervention includes 24 modules, to be used across 24 sessions targeting OEF/OIF Veterans     with hazardous or problematic substance use and PTSD symptoms. The investigators ask     participants to complete 2 sessions per week (one module per session) for 12 weeks. The first     18 modules to be completed across 18 sessions (9 weeks) are considered core modules relevant     to all Veterans in the target population. These modules are designed to reduce posttraumatic     stress symptoms as well as reduce and prevent the escalation of problematic substance use.     The remaining 6 module topics are considered optional and are used based on the interest     and clinical need of various sub-groups of VA patients. The study includes initial input as     well as feedback on a beta version from experts who have worked with OEF/OIF veterans with     PTSD and substance abuse problems as well as input/feedback from the target population (the     Veterans themselves). In addition to presenting content grounded in evidence-based CBT     interventions, the program also employs state of the art technologies to deliver module     content grounded in evidence-based learning principles, including Computer-Assisted     Instruction, Computer Simulation and other interactive exercises.   "
120326|NCT01710930|"     The main objective of this study is to determine if a doubling of serum TARC (compared to     baseline) is associated with the occurrence of exacerbations of ABPA.      The secondary objectives of the study are :        1. To investigate if induced sputum eosinophils count (compared to baseline) is associated          with the occurrence of exacerbations.        2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence          of exacerbations.        3. To investigate if activation of circulating T cells (compared to a baseline) is          associated with the occurrence of exacerbations.        4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline)          is associated with the occurrence of exacerbations.        5. To determine if the variation of one of the markers above, TARC or Asp f specific IgE          measured at baseline, may be associated with the radiological stage of the disease          (ABPA-S, ABPA-CB, ABPA-ORF).        6. To investigate if there is a link between fungal exposure at home (visually assessed by          the contamination level and the proportion of positive samples for Asp. f) and the          frequency of exacerbations.        7. To establish if some of the clinical, functional or biological data studied are          associated with the frequency of exacerbations.   "
120327|NCT01710917|"     This non-interventional, observational study evaluates the efficacy of Targinact with regard     to quality of life in daily clinical practice in Belgium compared to the previous analgesic     treatment.   "
120334|NCT01710826|"     To assess in healthy adult subjects:        -  The tolerability and safety of ascending repeated oral doses of Genz-682452.        -  The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.        -  The pharmacodynamics of Genz-682452 after ascending repeated oral doses.   "
120335|NCT01710813|"     To collect uniform and meaningful data on patients with Pompe disease who experience     anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic     immune complex-mediated reactions following treatment with alglucosidase alfa.   "
120336|NCT01710800|"     The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the     total number of reflux episodes in the distal esophagus measured by impedance in patients     with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In     addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs     also reduce the total number of reflux episodes due to its anti-secretory effects.   "
120337|NCT01710787|"     The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and     Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.   "
120338|NCT01710774|"     This study will investigate whether telemedicine follow-up care for people with     diabetes-related foot ulcers in municipal primary health care in collaboration with     specialist health care is an equivalent alternative to traditional outpatient clinical     follow-up in specialist health care (noninferiority trial) in relation to healing time.   "
120339|NCT01710761|"     Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance   "
120340|NCT01710748|"     This study is a prospective, randomized controlled, single blind, two-arm, multicenter     clinical evaluation.      Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of     the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)     Polymer-Based Everolimus-Eluting Stent.      The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent     implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based     Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as     the primary imaging modality.   "
120341|NCT01710735|"     In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will     explore muscle contractility characteristics, the occurrence of post-intervention muscle     soreness and the effect of dry needling on muscle contractile characteristics and clinical     outcomes.   "
120342|NCT01710722|"     The purpose of this study is to compare three treatments to see which causes the most weight     loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.   "
120343|NCT01710709|"     This will be an open-label uncontrolled trial to evaluate the safety and tolerability of     aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar     I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects     not participating in Trial 31-08-250.   "
120344|NCT01710696|"     This trial is conducted in Europe. The aim of the trial is to induce normal pubertal     development in girls with Turner Syndrome in accordance with that of their peers and their     individual state psychosocial maturation.   "
120345|NCT01710683|"     After lumbar discectomy 1st postoperative day high intensity exercise training reduced     hospital stay, pain and sick leave without side effects in the two year follow-up period.   "
120346|NCT01710670|"     To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects     of Ethanol   "
120347|NCT01710657|"     The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of     orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and     Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary     generalization.   "
120348|NCT01710644|"     The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to     Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine     Pancreatic Insufficiency due to Cystic Fibrosis   "
120349|NCT01710631|"     A six-month study to determine the safety and efficacy with an additional open-label     extension to determine the long-term safety of eszopiclone in the treatment of adult subjects     with primary insomnia.   "
120363|NCT01710436|"     This study is a prospective, observational study to estimate the relationship between dosage     of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators     suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention     (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.   "
120364|NCT01710423|"     This study aims to test the effectiveness of a community-located, peer mentored intervention     to improve home food preparation practices in families with young children.   "
120365|NCT01710410|"     The purpose of this study is to determine the effectiveness of transcranial direct current     stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine     dependent smokers.   "
120350|NCT01710618|"     The purpose of the study is to elucidate the different proteins that may appear on the     injured end of the sciatic nerve and compare it to the other end of the cut nerve, which is     uninjured. By comparing the normal versus traumatized ends of the cut sciatic nerve,     the investigators hope to identify proteins that may be specifically related to pain. For     instance, if the non-traumatized end of the nerve has none of Protein X but the traumatized     end of the nerve has a lot of Protein X, then Protein X would be a protein that the     investigators will want to study further and see if it plays any role in the sensation of     pain.      Other studies have shown that there are specific pain-related proteins and they may be     increased or decreased after traumatic injury. If the investigators are able to identify     specific proteins that are related to pain, then that may eventually lead to the development     of medications that will block those proteins and decrease the sensation of pain.   "
120351|NCT01710605|"     The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking     into account circulating tumor cells (CTC) to determine the kind of first line treatment for     metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of     treatment will be decided by clinicians, taking into account the criteria usually used in     this setting. In the CTC arm, the type of treatment will be decided by CTC count:     hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main     medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the     progression-free survival: 994 patients are needed, and will be accrued in French cancer     centers. Secondary clinical objectives are to compare toxicity, quality of life and overall     survival between the two arms. The medico-economic study will compare cost per     progression-free life years gained of the two strategies. The financial impact of centralized     (one platform) vs decentralized (several platforms) CTC testing will be evaluated.   "
120558|NCT01707888|"     Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS     major lung resection have been preferred as a standard radical procedure for early stage     non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major     lung resection for lung cancer as a real-world study in china.   "
120352|NCT01710592|"     Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced     gastro-oesophageal cancer, their role, however, in the management of this disease remains     unclear. Furthermore it is unclear whether this disease is optimally treated with a     combination of two or three cytotoxic drugs. This trial aims to determine whether the     combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal     phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the     comparator arm for this evaluation.      Primary Objective:      Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is     comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation     in advanced gastro-oesophageal cancer.      Secondary Objective:      To examine the effect of treatment on time to progression, progression free survival, overall     survival, quality of life, and the associated toxicity from treatment.   "
120353|NCT01710579|"     Ano-rectal manometry is indicative in patients with either fecal incontinence or     constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure     variations are measured circumferentially along the anal canal. It may allow a better     understanding of anorectal disorders by displaying anal pressure asymmetry and it could be     useful to assess the functional anatomy of the pelvic floor better than conventional     manometry.   "
120354|NCT01710566|"     This community-based cluster Randomised Control Trial will assess the feasibility, cost,     risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as     prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be     conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program to     deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective in     preventing PPH when introduced in community-based settings.   "
120355|NCT01710553|"     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,     single dose, oral bioequivalence study under fasting condition. It is a pivotal study to     demonstrate the bioequivalence of Metformin 1000 mg tablets manufactured by Savipharm J.S.C,     Vietnam and Glucophage® 1000 mg tablets of Merck Sante, France in healthy adult human male     subjects under fasting condition   "
120356|NCT01710540|"     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,     single dose, oral bioequivalence study under fasting condition. It is a pivotal study to     demonstrate the bioequivalence of Metformin 850 mg tablets manufactured by Savipharm J.S.C,     Vietnam and Glucophage® 850 mg tablets of Merck Sante, France, in healthy adult human male     subjects under fasting condition.   "
120357|NCT01710527|"     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,     single dose, oral bioequivalence study under fasting condition. It is a pivotal study.      To demonstrate the bioequivalence of Metformin 500 mg tablets manufactured by Savipharm     J.S.C, Vietnam and Glucophage® 500 mg tablets of MERCK SANTE in healthy adult human male     subjects under fasting condition and to monitor the safety of the study subjects.   "
120358|NCT01710514|"     The purposes of the study are to verify sufficient supplementation of luteal hormone after     administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to     determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing     fertility treatment with IVF-ET (a fresh embryo transfer).   "
120359|NCT01710501|"     This is a study designed to compare the safety and efficacy of 3 different doses of     grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin     (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC).     Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and     RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of     treatment with Peg-IFN and RBV.   "
120360|NCT01710488|"     The primary objective of the study is to determine the percentage of patients with     therapeutic success at the end of the cycle of antibiotic therapy (10 days), in the two     treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be     evaluated on the basis of a score determined in relation to the signs-symptoms of acute     exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)   "
120393|NCT01710033|"     This was a Phase 1 dose escalation study to evaluate the safety, tolerability and     pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In     Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of     subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort     in Stage 2.   "
120394|NCT01710020|"     There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered     approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the     drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a     second period (Period 2) will be conducted. In Period 2, a single dose of drug will be     administered approximately 4 hours prior to hemodialysis.   "
120366|NCT01710397|"     One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS     in resource-constrained settings is the failure of ART-eligible patients to complete the     steps required to initiate treatment. The high rate of loss to care of patients who are     treatment-eligible at HIV diagnosis may be due in part to the large number of steps required     between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In     South Africa, these steps usually require approximately four clinic visits over a period of     2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses     among those eligible for ART is to simplify and condense the steps required for starting     treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and     tuberculosis (TB) diagnosis are available. These technologies can be combined with changes to     clinic schedules to allow all steps required for ART initiation under South African     guidelines (lab tests, physical exam, education) to take place on the day the patient     presents for an HIV test.      This study is a randomized strategy evaluation of the feasibility, effectiveness, and     cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who     come to a South African clinic for an HIV test, consent to study participation, and are     eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those     who are assigned to rapid ART initiation will have the possibility of receiving their first     dose of ARVs as early as the same day, while those who are assigned to standard care will     follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive     pregnant women, which has recently become the standard of care in South Africa, will also be     assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a     retrospective comparison group. The primary study outcome for non-pregnant adults will be     remaining alive, in care and virally suppressed 10 months after having a positive HIV test at     the study site or making a first HIV-related visit. The primary study outcome for pregnant     women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation     strategy will be assessed as the cost per patient achieving the primary outcome for each     population.   "
120367|NCT01710384|"     To test the effect on premature infants of a one-time course of betamethasone administered in     weeks 34-36 of gestation.   "
120368|NCT01710371|"     To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late     type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects.     These subjects will also be evaluated for beta-cell function as measured by the insulin and     C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced     conditions.   "
120369|NCT01710358|"     The purpose of this study is to determine whether baricitinib is superior to placebo in the     treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who     have had an inadequate response to methotrexate (MTX) treatment.   "
120370|NCT01710345|"     This is a dose-finding study to determine if the sublingual administration of the Sufentanil     NanoTab is safe and effective in the treatment of post-operative pain.   "
120371|NCT01710332|"     A preliminary study to determine the safety and efficacy of intravitreal aflibercept     injection in patients with persistent central serous chorioretinopathy.   "
120372|NCT01710319|"     The purpose of this research study is to investigate the differences in natural killer (NK)     blood cells, a type of white blood cell that fights infection in the body, among different     types of patients that have lung surgery. The four different groups of patients are:        -  smokers with lung cancer        -  smokers without lung cancer        -  non-smokers with lung cancer        -  non-smokers without lung cancer.   "
120373|NCT01710306|"     Women and Reserve/National (RNG) Veterans are among the fastest growing groups of new VA     users. While PTSD is prevalent in this group, most women don't access or complete needed     treatment. This study will investigate OEF/OIF/OND RNG female war Veterans' perceptions,     preferences, barriers and facilitators to accessing VA mental health (MH) and evidence-based     PTSD psychotherapy. This information will be used to revise an existing web-based screen that     educates participants about their unique post-deployment MH conditions. This web-interface     will then be used to randomly assign women who screen positive for PTSD to either 1) a     concierge nurse case manager who uses shared decision-making to engage Veterans in EBP or 2)     usual outreach to determine what engagement approach women prefer. The investigators'     findings will provide VA leaders with key information to understand and improve access to RNG     PTSD treatment.   "
120374|NCT01710293|"     Many missed and delayed cancer diagnoses result from breakdowns in communication and     coordination of abnormal findings suspicious for cancer, which often first emerge in the     primary care setting. Delays in the follow-up of abnormal test results persist despite the     reliable delivery of test results through the electronic health record.      This intervention is the final study in a three-phase project that will develop and test an     innovative automated surveillance intervention to improve timely diagnosis and follow-up of     five common cancers in primary care practice.      The investigators hypothesize that the median time in days from diagnostic clue to follow-up     action (e.g. time to colonoscopy examination after am abnormal colon-related test) will be     significantly less in the intervention arm than in usual care. The investigators also     hypothesize that the proportion of patients receiving appropriate and timely follow-up care     will be significantly higher in the intervention arm than in usual care.   "
120375|NCT01710280|"     The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the     sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting     triacylglycerol concentrations.   "
120376|NCT01710267|"     Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied     for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA     is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for     prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.      This is an explorative laboratory study to evaluate the intra-individual variability of RXA     conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.   "
120383|NCT01710163|"     The purpose of this study is to determine whether Bipolar I Disorder refractory treatment     with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The     investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and     tolerability in maintenance treatment.   "
120377|NCT01710254|"     Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a need     for research to elucidate the prevalence of ischemic cardiomyopathy in patients diagnosed     with AF. The objective of this study is to demonstrate the utility of MRI in assessment of     coronary artery disease. The specific objective is to demonstrate sensitivity/specificity     comparable to that reported in meta-analyses of non-AF patients and adenosine (90% /80%) in     an AF population using the time-efficient vasodilator regadenoson that requires only a single     intravenous (IV).   "
120395|NCT01710007|"     1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its     active compound, pitavastatin has recently been approved by US FDA for indications of primary     hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic     properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does not     depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and safety of     1PC002 administered for 12 weeks is non-inferior to atorvastatin.   "
120378|NCT01710228|"     This study is being done to determine the difference between natalizumab therapy followed by     two different withdrawal strategies using Glatiramer Acetate (GA) treatment paradigms in     preventing clinical relapses and other markers of disease activity in patients diagnosed with     Multiple Sclerosis (MS).      We hypothesize that GA plus corticosteroids versus GA alone will prevent or reduce the     re-occurrence of MS disease activity after discontinuation of natalizumab over a 12 month     period. We further hypothesize that natalizumab therapy followed by GA treatment allows the     reconstitution of the peripheral and CNS immune homeostasis.      Primary objective:      The primary endpoint will be the annualized relapse rate over the post randomization months     as well as estimates of change over the natalizumab therapy period over the entire 12 months.      Secondary objectives:      To determine if and how long it takes for restoration of immune homeostasis under GA therapy     following discontinuation of natalizumab.   "
120379|NCT01710215|"     Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death     can be reduced by screening. However, there is uncertainty as to which screening strategy is     most clinically and cost-effective from a population perspective where the aim is to optimize     completion of the entire screening process continuum. Modeling studies suggest benefits and     harms of colonoscopy and stool blood test strategies are similar, but generally assume 100%     participation and subsequent clinically appropriate follow up--something never achieved in     clinical practice. Comparative effectiveness studies of testing strategies, including     comparisons of specific tests and approaches to optimizing effective test use, are necessary.     Safety-net health systems care for populations at increased risk for adverse CRC outcomes,     such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets     must resolve the uncertainty regarding the most effective screening strategy. The     investigators will conduct a system-level, randomized comparative effectiveness trial of the     benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age     50-64 years, who are not up-to-date with CRC screening, served by a large safety net health     system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual     mailed invitation outreach (including a test kit), and a centralized process to promote     participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed     invitation outreach, and a centralized process to promote participation and complete clinical     follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at     primary care visits. The primary measure of benefit will be an outcome measure that     summarizes patient-specific effective screening successes. The primary measure of harm will     be screening non-participation. The primary measure of cost will be cost per-patient     effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a     FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with     screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care     and b) the Colo strategy vs. Usual Care for CRC screening.   "
120380|NCT01710202|"     The current study will test the causal relationship between elevated levels of cortisol and     the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to     environmental threat. The investigators predict that carriers of the short allele of the     serotonin transporter gene who have elevated cortisol levels will be most sensitive to     threatening environments, whereas carriers of the long allele who do not have elevated     cortisol (placebo subjects) will be least sensitive.   "
120381|NCT01710189|"     Many viral infections of global importance, including HIV, are transmitted across the mucosal     surface of the genital tract. As immunity against these infections is likely to be primarily     mediated by antibodies in mucosal secretions, developing techniques to increase the levels     and persistence of antiviral antibody on mucosal surfaces may enhance the protection against     a number of important infections. Preclinical studies have anatomically targeted vaccine     antigens to sites where genital tract immunity is induced. This response is likely due to the     ability of regional lymph Preclinical studies have anatomically targeted vaccine antigens to     sites where genital tract immunity is induced. This response is likely due to the ability of     regional lymph nodes to pattern the cell surface markers of responding vaccine specific     lymphocytes with homing markers. In contrast, injecting a distant muscle (such as in the arm)     which shares no anatomical relationship with the vagina, may not pattern cells with homing     markers for the genital tract. Direct injection of inguinal lymph nodes is impractical in     humans but intramuscular injection into the thigh will target antigens to the deep inguinal     lymph nodes shared in common with the cervix/vagina.      This study will be a Phase IV randomised, single centre, open label, laboratory assessment     blinded exploratory trial to assess mucosal immunogenicity following three targeted     intramuscular immunisations with TicoVac vaccine. 20 subjects will be randomised to each of2     groups immunised in right deltoid or right anterolateral thigh.      Following an initial screening visit subjects will be immunised at 0, 1 and 6 months. There     will be follow up visits 5 days after each immunisation and a final visit at 7 months. Blood     samples and cervicovaginal secretions will be taken prior to each immunisation for     immunological measures. In addition, blood samples will be taken at each immunisation and     follow up visit for measurement of peripheral blood mononuclear cells.      The study is funded by ADITEC, which is a collaborative research programme that aims to     accelerate the development of novel and powerful immunisation technologies for the next     generation of human vaccines.   "
120382|NCT01710176|"     This is a randomized Phase III clinical trial in the setting of localized high-risk soft     tissue sarcomas (STS). This study will compare a standard neoadjuvant chemotherapy with     epirubicin plus ifosfamide versus a histology-driven chemotherapy, i.e. a chemotherapy     tailored to the specific histology within the family of adult STS. Chemotherapy will be     administered for 3 cycles. There will be five histological groups (representing 80% of STS),     as follows: leiomyosarcoma, myxoid liposarcoma with hypercellularity (round cell MLPS),     synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST) and undifferentiated     pleomorphic sarcoma. The histology-driven chemotherapy for these groups will be,     respectively, gemcitabine plus dacarbazine, trabectedin, high-dose ifosfamide, ifosfamide     plus etoposide, gemcitabine plus docetaxel. Other histological groups will also be included     and registered, but treated only by standard chemotherapy. Patients who have already     undergone definitive surgery will receive treatment post-operatively and patients needing a     re-excision after inadequate surgery will be treated as patients in the two groups, but of     course will not be evaluable for response. A centralized pathological review will be     performed. Radiological response will be evaluated according to RECIST and to Choi criteria.     Pathological response will also be recorded.      The endpoint will be disease-free survival (DFS) and, secondarily, overall survival (OS) of     patients receiving standard chemotherapy versus those receiving histotype-tailored     chemotherapy. Additional aims will be to compare the probability of response of standard vs     histotype-tailored chemotherapy and to determine the radiological and pathological response     with standard chemotherapy vs tailored chemotherapy in each different histological group.     Another aim will be to validate the response (both radiological and pathological) to     preoperative chemotherapy as a surrogate endpoint for DFS and OS.      Three hundred patients will be randomized over a 3-years period, from a pool of 400-450     registered patients.      Translational research will be performed. Areas of research will include identification and     validation of the potential predictive markers for each histological subgroups.      The study is designed to verify the statistical hypothesis that histotype-tailored approach     is associated, overall, with a 30% reduction in the hazard of relapse. However, in each     different histological group, the effect of histotype-tailored chemotherapy, as compared to     standard chemotherapy, can be different. To address this weakness an orthogonal study of     response to chemotherapy as a surrogate of DFS and OS has been introduced into the trial.     This study intends to extensively investigate the response (radiological and pathological) to     preoperative chemotherapy and to validate it as a surrogate endpoint by showing that it     correlates with disease free survival and overall survival.   "
120434|NCT01709500|"     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study     alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia     (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).   "
120384|NCT01710150|"     The purpose is to compare long term occurrence of atrial arrhythmias including atrial     fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in     patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation     alone versus CTI ablation combined with pulmonary vein isolation (PVI).   "
120396|NCT01709994|"     The objective of the study is to examine whether the use of low-dose aspirin (75-100 mg /     day) reduces the risk of cardiovascular disease in patients with chronic kidney disease     (stage 3 or 4).   "
120408|NCT01709838|"     To assess the efficacy of deferasirox in patients with non-transfusion dependent thalassemia     based on change in liver iron concentration from baseline after 52 weeks of treatment. To     provide further assessment of the long-term efficacy and safety of deferasirox in NTDT     patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260     weeks.   "
120385|NCT01710137|"     Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral     therapy (HAART) has greatly improved survival rates and changed the leading causes of death,     from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use     among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious     for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310     smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation     counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators     hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment     (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2)     quality of life will be rated higher in the varenicline and counseling group versus the     placebo and counseling group, and there will be no significant differences between treatment     arms in terms of the frequency of severe varenicline-related side effects; and 3) improved     affect and reduced cognitive impairment will mediate the effect of varenicline therapy on     quit rates.   "
120386|NCT01710124|"     The prevalence of overweight and obesity among older adults has reached an all-time high,     which puts this age group at high risk for associated comorbidities such as type 2 diabetes,     cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and     economic uncertainty, many middle-aged and older Americans tried to save on their food     purchases during the 2007-2009 recession. Grocery coupons, available through newspapers,     mail, and increasingly online, are one of several promotional tools that supermarkets and     warehouse clubs use to promote sales. It is estimated that nationally 27% of households are     frequent grocery coupon users who shop at a variety of retailers. Despite the increasing     popularity of grocery coupons, little is known about the extent to which they may promote     obesogenic home food environments and eating behaviors. Many coupons advertise the purchase     of large quantities of prepackaged and processed foods and often reward shoppers by adding     'free' products if they purchase certain quantities. Availability and easy accessibility of     large portions of energy dense foods in the home has been shown to promote increased intake.     The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary     intake, weight status, and home food availability among middle-aged and older adults. A     second aim of this study is to test, in a randomized-controlled trial, the effects of     incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in     dietary intake, body mass index/waist circumference, home food availability, and grocery     coupon use among frequent coupon users and non-coupon users.   "
120387|NCT01710111|"     The ways in which influenza is transmitted between people are uncertain; for example, we do     not know if large droplets or fine particles (aerosols) matter most; both are produced by     coughing and sneezing. This means we cannot say what precautions work best in real life.     Improving our understanding is vital to allow the development of guidelines and policies to     help reduce the transmission of both pandemic and seasonal flu.      The aim of this study is to explore how influenza is spread, specifically by looking at the     importance of spread via small particles (aerosols/droplet nuclei) that are carried in     respiratory sprays e.g. produced by coughing and sneezing.      The primary objective of this study is:      To estimate the contribution of aerosols/droplet nuclei to influenza transmission by     determining the secondary attack rate (SAR) of influenza in Recipients randomised to a     control arm (no intervention - allowing all modes of transmission) compared to Recipients     randomised to an intervention arm (face shield and hand hygiene - allowing only transmission     by aerosols/droplet nuclei) when both groups of Recipients are exposed to Donor volunteers     infected with influenza via intranasal drops.      The hypothesis is that:      The SAR will be lower in Recipients exposed only to aerosols/droplet nuclei (intervention     arm) compared to those exposed to all modes of transmission (the control arm):     aerosols/droplet nuclei, droplet spray (larger respiratory droplets) and transmission through     contact.   "
120388|NCT01710098|"     How are testosterone levels of patients with prostate cancer under treatment with Firmagon®     changing.      Former studies showed a quick fall of testosterone levels after start of therapy with     Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this     in a normal outpatient urologist setting. Furthermore data is collected to prove the     adherence to the German S3-Guideline for the treatment of prostate cancer.   "
120389|NCT01710085|"     Endometrial and cervical cancers are one of the most common malignancies seen in females.     Identification of recurrent disease in early phases of treatment carries a primary importance     on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new     technique recently started to be performed in body imaging and has potential ability to     detect recurrent disease. The aim of this study is to investigate the diagnostic impact of     DWI in detection of recurrent disease in patients treated with curative surgery in     endometrial and cervical cancer.   "
120406|NCT01709864|"     The study serves to determine whether the treatment of patients with stable, symptomatic     Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is     efficient and safe. The efficacy and safety of the drug will be tested against a placebo     treatment.      The primary criterion to assess efficacy will be the difference between the serial lung     function measurements of patients who have been treated for 12 weeks with NVA237 versus those     that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1     testing) will be conducted and the area under the curve will be the measure for the ability     to breathe.   "
120390|NCT01710072|"     Hypothesis: aspirin attenuates inflammation in cerebral aneurysms and hence reduces the     incidence of rupture. This effect can be monitored using the signal generated by macrophages     (inflammatory biomarker) in ferumoxytol-enhanced MRI.      Study aims:      1. Determine if daily aspirin intake (for three months) would obliterate/reduce     ferumoxytol-enhanced MRI signal changes generated by macrophages in cerebral aneurysm wall.     Fifteen patients with cerebral aneurysms > 7 mm will be selected to enroll in this pilot     study. 10 patients will be imaged at base line with ferumoxytol-enhanced MRI. Following that,     they will take aspirin 81 mg daily and then re-imaged again at three months. This group will     be compared to a control group of 5 patients where they will have the imagings studies     performed at base line and at three months but will NOT take aspirin.   "
120391|NCT01710059|"     This study has two main goals. The first goal is to test whether a mobile phone intervention     can increase adherence to daily inhaled steroid medications in African American adolescents     prescribed this type of medication by his/her asthma doctor. The second goal is to use a     mobile phone intervention to better understand real life patterns of use of quick-relief     (beta2-adrenergic agonist) asthma medication in this population.   "
120392|NCT01710046|"     There are cells in the skin and blood of humans with chronic moderate to severe plaque     psoriasis with specific activities that may determine the effectiveness of treatment. These     activities may be described by obtaining samples of skin and blood and analyzing them using a     variety of tests.   "
120397|NCT01709981|"     Peri-procedural inflammation is associated with increased rates of post-procedural myocardial     infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with     increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates     during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side     effects such as myalgia. Moreover, because their mechanism of action relies on     post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame     that is not always feasible. The investigators propose a novel alternative approach to reduce     inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently     in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to     its rapid onset of action and excellent side-effect profile at low doses, as well as its     known mechanisms of action. However, data on colchicine use in patients with coronary disease     is extremely limited, and no studies to date have evaluated the use of colchicine in patients     undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in     patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte     surface markers after PCI. The investigators also aim to determine the effects of colchicine     on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective     randomized study to characterize the effect of colchicine on inflammation and peri-procedural     myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded     fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour     later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints     will include other relevant soluble and leukocyte-associated inflammatory markers and rates     of peri-procedural myonecrosis and MI. Sample size needed is 200 patients undergoing PCI. To     adjust for a floor effect, 280 patients undergoing PCI will be needed. 400 patients will     likely be needed to be enrolled to reach 280 PCIs (the remaining will have undergone a     diagnostic only procedure).   "
120398|NCT01709968|"     Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at     rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential     benefits in trials of magnesium. This is a single center, prospective, randomized, double     blind, placebo controlled clinical trial that aims to investigate the effect of treatment     with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide &     Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and     severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the     number and severity of NLC; an improvement in the quality of life and quality of sleep may     ensue.   "
120399|NCT01709955|"     The purpose of this study is to determine if the herb, Glucomannan, is an effective     non-pharmacological appetite suppressant for overweight or Class I obese patients. The study     design will not include any other lifestyle changes which enhance weight loss in order to     completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.   "
120400|NCT01709942|"     In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a     unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian     hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.   "
120401|NCT01709929|"     This trial is conducted in North America. The aim of this trial is to evaluate the safety of     insulin detemir for the treatment of diabetes.   "
120402|NCT01709916|"     Glaucoma is one of the leading causes of blindness in the west. The disease caused by high     intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss     of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of     the therapy it is common to measure the intra ocular pressure at different times of the day.     Most ophthalmologists admit the patient for one day at which intra ocular pressure is     measured at different times. This method does not mimic the patient daily routine and may not     reflect the true diurnal fluctuations.      For this reason some ophthalmologists measure the intra ocular pressure at different times     and at different days. It is not known if both methods give similar diurnal curves.   "
120403|NCT01709903|"     To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50     µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours     15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with     moderate to severe COPD   "
120404|NCT01709890|"     Patients under sedation not uncommonly develop upper airway obstruction or other respiratory     complications and no airway device is available to provide reliable maintenance of the airway     at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway     in most sedated patients and improve O2 delivery to the airway. In addition it may also     greatly facilitate the monitoring of expired CO2, which is widely recognised as the most     important monitor of adequacy of breathing, yet frequently impossible to perform     satisfactorily in sedated patients at the moment.   "
120405|NCT01709877|"     Its main objective is to evaluate the clinical outcome (including patient reported outcomes)     and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic     Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled     prospective clinical trial (RCT) on specific operations performed (on a random allocation     basis) by either the traditional multi-port laparoscopic approach or the Single Port-     ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion     criteria will be randomised over a three year period to have the operation by either of the     two approaches.   "
120435|NCT01709487|"     First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy     (HIPEC) after optimal debulking.   "
120407|NCT01709851|"     Over the last years, a number of systems for continuous subcutaneous glucose monitoring have     been marketed and are routinely used in patients with diabetes to obtain more detailed     information about 24-hour glucose profiles.      In the hospital, numerous factors influencing glycemic control and possibly leading to     glucose excursions out of the desired range exist, e.g. interventions for which the patient     has to remain fasting or medications such as corticosteroids or vasopressors. A reliable     continuous glucose signal could help to observe levels of glycaemia not only at defined     time-points but continuously, making it possible for physicians and nursing staff to better     adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo-     or hyperglycaemia.      In the hospital setting, vascular access is granted in the majority of patients and could as     well be used as an alternative site for continuous glucose monitoring.      The aim of the present study is to assess accuracy of the glucose data obtained by means of     an intravascular microdialysis-based CGM system against venous blood glucose reference     measurements.   "
120410|NCT01709812|"     A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study     in RRMS patients to assess the impact of an individualized patient support program (PSP) on     treatment satisfaction and to evaluate whether this individualized support improves     satisfaction and with it adherence to medication compared to standard care.   "
120411|NCT01709799|"     The purpose of this research study is to help scientists and health care providers learn more     about preventing dementia and brain disease in older adults. There is an urgent need to     develop strategies to prevent or slow down memory loss and brain function decline in the     elderly.      In this study, the investigators hope to learn how physical exercise and a brain training     program work together to improve thinking and memory in older adults. Specifically, these     aims include:        -  Learning whether physical activities (like biking or treadmill walking or Wii Fit games)          will help improve the benefits of a brain training program. Based on preliminary results          and that in the literature, the investigators anticipate greater cognitive benefits in          the Exercise + Cognitive training groups than the Cognitive Training alone group.        -  To determine whether the benefits of adding exercise will occur quickly or develop more          gradually over time. The investigators suspect that a major benefit of exercise          pre-dosing will occur by the 12th week of the program.        -  To examine whether Wii-Fit exercise games cause similar effects on brain training as          traditional exercise programs such as biking or walking. Although several recent studies          have raised questions about the true aerobic benefit of exergames such as Wii-Fit Plus,          other evidence suggests that these weaker aerobic benefits may be offset by the greater          novelty and interest level afforded by exergames.   "
120412|NCT01709786|"     This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in     patients with suspected hemorrhage. These methods will be compared with standard laboratory     measurements.   "
120413|NCT01709773|"     This is a pilot cohort study of women undergoing focal ablation for high-grade cervical     intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics.     The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting     inclusion criteria were recruited for enrollment into the pilot study of focal treatment.     Upon enrollment, they underwent focal ablational treatment rather than standard ablational     treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess     safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be     calculated.   "
120414|NCT01709760|"     A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,     Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with     Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis   "
120415|NCT01709747|"     The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride     administered by intrathecal delivery.   "
120416|NCT01709734|"     A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration     resistant prostate cancer (CRPC) patients.   "
120417|NCT01709721|"     The purpose of this study is to determine the safety and efficacy of hydromorphone     hydrochloride by intrathecal administration using a programmable implantable pump.   "
120418|NCT01709708|"     Migraine imposes a substantial burden on patients in terms of diminished daily functioning,     quality of life, and financial loss. Pain severity and duration correlates with reduced     measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG)     has been implicated in a variety of cephalalgias. This has been well represented in the     literature dating back over a century. Access to this structure can be gained via a small     area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral     nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG using     local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome,     invasive, and expensive. The purpose of this study is to evaluate the efficacy of the Tx360™,     a new nasal applicator device, in the treatment of head and face pain and to examine the     economic implications. The Tx360™ is a single use device designed to deliver a topical local     anesthetic to the specific area of mucosa associated with the SPG. A total of 42 study     participants will be accepted into this double-blind placebo-controlled study. 28 will     receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the Tx360™     while 14 will receive a placebo of saline substituted for the Marcaine. Both patient sets     will also be given a piece of lemon hard candy as a taste distractor. Participants must have     a chronic migraine history with over 15 symptomatic days per month over the past three     months. The treatment plan consists of six weeks of treatment, two times per week. Short and     longer term assessments will be retrieved and analyzed as detailed in the Study Design.   "
120419|NCT01709695|"     This study proposes to evaluate the effects of guanfacine extended release on brain     activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD     subjects randomized to placebo treatment.      This study also proposes to collect DNA on study participants, to examine the genetic     underpinning of the observed fMRI activation profiles at baseline and in response to     treatment. The purpose is to examine polymorphisms of the adrenergic 2A gene (and other     related targets) for genetic biomarkers in association with the fMRI findings of this study.   "
120420|NCT01709682|"     The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy     (control) in patients with previous failed PVI ablation for paroxysmal AF.   "
120421|NCT01709669|"     Overall, the investigators aim to recruit 150 subjects during their hospitalization for an     acute coronary syndrome (ACS). At two weeks post-ACS, the investigators will assess levels of     gratitude and optimism, draw blood for baseline levels of biomarkers, gather baseline     information about health behaviors critical to cardiac health, and obtain baseline measures     of symptoms and function. Finally, the investigators will repeat assessments of biomarkers,     behavior, and function at 6 months to allow us to assess the impact of gratitude and optimism     on these outcomes; the investigators will also have an objective measure of physical activity     via accelerometer (step counter) at 6 months.      Specific Aim #1: To prospectively assess the association between gratitude/optimism 2 weeks     after ACS and improvement in biological markers of cardiac health at 6 months post-ACS.      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater     reductions in levels of biomarkers associated with negative heart health between 2 weeks and     6 months.      Specific Aim #2 (*primary aim*): To assess the association between gratitude/optimism 2 weeks     after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at     6 months.      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater     amounts of physical activity (measured by accelerometer) at 6 months (primary study outcome     measure), and greater improvements in self-reported adherence to health behaviors (activity,     diet, and medication) between 2 weeks and 6 months.      Specific Aim #3: To assess the association between gratitude/optimism at 2 weeks and     non-elective cardiac rehospitalizations (and other clinical outcomes) at 6 months.      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater     improvements in depression, health-related quality of life, function, cardiac symptoms, and     possibly readmissions, between 2 weeks and 6 months.   "
120422|NCT01709656|"     The investigators will recruit active ankylosing spondylitis patients for injection treatment     of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine     controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs)     and sera before and after the treatment of 24 weeks to test the gene expression profiles and     study related pathogenesis of AS   "
120423|NCT01709643|"     The major research objective is to assess the potential of Proton Magnetic Resonance     Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single     meal. Furthermore we aim to investigate whether the addition of protein to a high fat     breakfast results in a reduced postprandial accumulation of lipids when compared to a high     fat breakfast alone.   "
120424|NCT01709630|"     Determine significant correlations between maternal serum magnesium levels, and maternal and     neonatal outcomes.   "
120425|NCT01709617|"     Carbohydrates are an integral component of sports nutrition. Providing carbohydrate (CHO)     during exercise delays the onset of fatigue and improves exercise performance by maintaining     high rates of CHO oxidation. Traditionally, glucose, or glucose polymers have been the     preferential CHO source found in sports drinks. However, during the intestinal absorption of     large amounts of glucose (>1.2 g/min), sodium-dependent glucose transporters (SGLT1) may     become fully saturated, potentially limiting the rate of exogenous CHO oxidation. In an     effort to evade this limitation, research has suggested using multiple transportable     carbohydrates in the composition of sports drinks. Multiple transportable carbohydrates are     combinations of simple sugars that use different intestinal transporters during the     absorption process. Ingesting multiple transportable carbohydrates may enhance the capacity     for total intestinal CHO absorption, leading to an increase in the rate of exogenous CHO     oxidation. Our purpose will be to examine the disaccharide sucrose in it's ability to provide     exogenous fuel during and following prolonged exercise.   "
120426|NCT01709604|"     Paraquat poisoning is characterized by multiple organ failure and pulmonary fibrosis with     respiratory failure. Accumulating evidence suggested that continuous venovenous     hemofiltration (CVVH) had a beneficial role in the treatment of multiple organ dysfunction.     The investigators hypothesized that CVVH might restore multiple organ function and reduce the     high mortality rate of paraquat poisoning. To confirm it, an prospective clinical study would     be carried out.   "
120427|NCT01709591|"     The purpose of the study is to determine if targeted prenatal educational program on womens'     perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative     to the control group.   "
120428|NCT01709578|"     Primary Objective:      To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were     effective for:        -  reduction of signs and symptoms at Week 24 and        -  improvement of physical function at Week 12      in participants with active rheumatoid arthritis (RA) who were inadequate responders or     intolerant to tumor necrosis factor alpha (TNF-α) antagonists.      Secondary Objectives:      The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to     DMARD therapy, in participants with active RA who were inadequate responders or intolerant to     TNF-α antagonists, for:        -  Reduction of signs and symptoms at Week 12;        -  Improvement in physical function at Week 24;        -  Improvement in disease activity score as measured by other American College of          Rheumatology (ACR) derived components at Weeks 12 and 24;        -  Improvement in quality of life as measured by participant reported outcomes (PROs) at          intermediate visits and Week 24.      To assess the exposure of sarilumab added to DMARD therapy in this population.      To assess the safety of sarilumab in this population.   "
120429|NCT01709565|"     The purpose of this study is to compare lactate clearance in patients with severe sepsis and     septic shock according to the presence of hepatic dysfunction.   "
120430|NCT01709552|"     The purpose of this study is to target co-occurring problems of substance use and intimate     partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for     Substance use and partner Abuse for Females in the Emergency Room). This project will develop     and test the computer-based intervention, examining primary outcomes of substance use and     utilization of relationship safety resources.   "
120431|NCT01709539|"     The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum, DC)     in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious illness     but who have no organ-specific symptoms will be referred to the DC for further investigation     after preliminary assessment in primary care. The overall purpose of the study is to evaluate     whether the DC meets its target time for diagnosing cancer. In addition, we will evaluate     secondary issues, such as survival, to determine whether this pilot project merits extension     to other parts of southern Sweden.   "
120432|NCT01709526|"     The aims of this six month follow-up study are which treatment components will correlate or     which clinical treatments interventions contribute adolescent inpatients recovering in the     psychiatric treatment after discharge. Comparisons will be made between the 47 adolescents     aged 13 to 18 years, with major depression and conduct disorders, and between those with and     without suicide attempts by multivariate analyses. Are the adolescent psychiatric inpatients     recovered?   "
120433|NCT01709513|"     This is a randomized, double-blind, double-dummy, active-controlled, parallel-group,     multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe     in participants with primary hypercholesterolemia and moderate, high, or very high CV risk,     who are intolerant to statins. An atorvastatin arm is added to determine that the population     selected in the study is a truly statin intolerant population by assessing skeletal     muscle-related adverse events.   "
120436|NCT01709474|"     The primary objective of this study is to evaluate the effects of 18 weeks of high-dose     vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune     function, glucose homeostasis, and bone metabolism in children with systemic lupus     erythematosus (SLE) and serum 25-hydroxyvitamin D [25(OH)D] levels ≤20 ng/mL.   "
120438|NCT01709448|"     The purpose of this study is to determine whether a model can be created to predict the     progression of early anal cancer precursor lesions in HIV using potential predictors such as:     HIV treatment history, smoking history, sexual history, human papillomavirus viral load,     human papillomavirus protein expression, and cell markers associated with progression of     HPV-related lesions.   "
120439|NCT01709435|"     This phase I trial studies the side effects and best dose of cabozantinib S-malate in     treating younger patients with solid tumors that have come back or no longer respond to     treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
120440|NCT01709422|"     The purpose of this study is to compare efficacy and safety of combination of propofol and     midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP   "
120441|NCT01709409|"     The purpose of this study is to see if a medication called Curosurf can reduce the length of     time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS,     stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a     medication that is already used in other countries around the world but not yet in Canada.      Babies born under 32 weeks of gestation frequently need respiratory support after birth,     including being placed on a breathing machine or respirator. The most common reason is     Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a     soapy like substance that helps the air sacs open and close. Our current standard treatment     is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore     the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be     able to be removed from the ventilator sooner.      Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the     investigators will monitor their progress during their Neonatal Intensive Care Unit     admission.      The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra     tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this     study.   "
120442|NCT01709396|"     Acute myeloid leukemia (AML) is a rapidly fatal malignancy of the bone marrow. It can be     treated with chemotherapy alone, in some cases, but in the majority of cases, the only     treatment that can cure the disease is an allogeneic stem cell transplant, with a cure rate     of 30-40%. In another subset, the disease is less responsive to chemotherapy and in these     aggressive forms, its cure rate is no better than 20% beyond 2 years, and is usually rapidly     fatal within 6 months.      Therefore, for this most aggressive form of the disease, modifications to the transplant     protocol are required in order to try to improve on these poor results. There are a number of     areas within the transplant protocol on which modifications can be made in order to achieve     these goals. These include: higher doses of chemotherapy and or radiation; alterations of the     new bone marrow graft; and alterations of the immune suppression, enhancing the graft vs.     leukemia effect. By focusing on one or more of these components, one might be able to enhance     the anti-leukemic aspect of the treatment resulting in a more successful outcome.      One aspect the investigators, in Ottawa, have focused on is the initial intensive     conditioning regimen, specifically the radiation component. It is the investigators belief     that in the most resistant disease it is important to use the highest tolerable anti-leukemic     treatment upfront, specifically, enhancing the radiation component of the initial     conditioning regimen. Previous studies have suggested that higher doses of radiation might be     more effective at eliminating the disease, however, toxicity and logistics of delivering the     radiation have limited its use. Technical advances in the delivery of radiation have now     permitted the safer use of high doses of radiation.      Through modifications to the transplant procedure, the investigators believe that they can     deliver higher doses of radiation safely and this will translate into improved outcomes in     this high-risk subgroup of patients with AML.      Study Objectives      The goal of this study is to determine if a total dose of 18Gy ED-TBI followed by an alloHSCT     for patients with refractory AML will result in an improved progression-free survival.   "
120443|NCT01709383|"     This study tests whether weak electrical stimulation of the brain is effective in improving     language or reading difficulties occurring after a brain injury or stroke.   "
120444|NCT01709370|"     This is a phase II study evaluating the efficacy and safety of the pre-operative use of     letrozole plus PD 0332991 (combination therapy)   "
120445|NCT01709357|"     The purpose of this study was to investigate the short and medium-term effects of three     manual techniques on cervical range of motion and pressure pain sensitivity in subjects with     mechanical stress, presenting latent trigger point of upper trapezius muscle.   "
120446|NCT01709344|"     Older adults who are treated for cancer are at risk of developing disabilities due to the     symptoms of cancer and the side effects of treatment. Disability occurs when a person has     trouble performing the activities he or she needs to do in everyday life. For example,     fatigue and pain can make it difficult for an older adult to do housework, leisure, or     volunteer activities. Disability makes it harder for older adults to stay active and be     productive members of the community, and it can increase the costs of healthcare.      Current approaches to cancer rehabilitation focus on using exercise, education, and social     support to reduce cancer treatment side effects. These are important strategies to reduce     disability, yet some side effects persist despite best efforts to resolve them. To fully     reduce disability, people often need to adapt their activities or the environments in which     they are performed.      The goal of this study is to test an occupational therapy (OT) intervention that teaches     activity planning skills to foster survivors' ability to adapt activities, routines, and     environments in order to minimize disability. The project targets adults over the age of 65     who are experiencing disability during or after cancer treatment. The project has two stages.     First, twelve older adult cancer survivors will individually participate in the     community-based intervention. After they have completed the program the investigators will     revise the intervention to emphasize what they found most effective and helpful, and to     eliminate aspects of the intervention that are perceived as unhelpful or redundant. The     research question for this first stage of the project is, To what degree is it feasible for     survivors to enroll in the study, complete the six-week intervention, and complete the three     outcome assessments? In the second stage of the project, the investigators will test the     revised intervention, comparing it to conventional care. The research question for the second     stage of the project is, Do the people receiving the intervention have higher activity     levels, greater behavioral activation, lower levels of disability, and better quality of life     compared to those people who receive traditional cancer care? The intervention is     appropriate for people who have been diagnosed with any type of cancer. It is designed to     focus on whatever activities are most important to each participant. The novelty of the     proposed intervention lies in the combination of the OT strategies of activity and     environmental adaptation with explicit training in activity planning to teach survivors to     find creative ways to engage in valued activities (e.g., taking care of one's home and family     members, and participating in leisure, community, social and work activities). If the     intervention is effective in reducing disability, it will give us another tool to reduce the     impact of cancer on the daily lives of cancer survivors.   "
120447|NCT01709331|"     This study will assess if corifollitropin alfa (MK-8962), when administered in combination     with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who     remain azoospermic after treatment with hCG alone.      Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in     testicular volume from Day 1 to Week 52 is greater than one.   "
120448|NCT01709318|"     The study is designed to the evaluate ovulation inhibition, vaginal bleeding, and     pharmacokinetics associated with three different doses of two next generation vaginal rings     (NGRs), identifying at least one whose control of menstrual cycles is not inferior to that of     NuvaRing®.   "
120552|NCT01707966|"     The main objective of this multicenter, randomized, double-blind, placebo-controlled phase     III trial is to assess the impact of maintenance orteronel on disease progression and hence     on quality of life in patients with metastatic castration-resistant prostate cancer who have     achieved at lease disease stabilization after first line chemotherapy with docetaxel.   "
120449|NCT01709305|"     To assess the effect of adding acarbose or repaglinide or gliclazide to sitagliptin plus     metformin, compared to adding glimepiride, on glycemic improvements in Type 2 Diabetes     Mellitus (T2DM) participants who require the addition of a third oral anti-hyperglycemic     agent (OAHA) according to China Guideline for Type 2 Diabetes. The three co-primary     hypotheses are that after 24 weeks of treatment in phase 2, the mean change from baseline in     hemoglobin A1c (A1c) in participants receiving either (1)acarbose or (2)repaglinide or     (3)gliclazide added to sitagliptin and metformin combination is non-inferior to that of     participants receiving glimepiride added to sitagliptin and metformin combination. The study     would be declared successful if at least one of the three primary hypotheses was met.   "
120450|NCT01709292|"     The goal of this clinical research study is to learn about how vemurafenib may affect certain     biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be related to     your reaction to the study drug. The safety of this drug will also be studied.      Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and     cancer growth. By blocking this mutation, the drug may kill the cancer cells with the     mutation and/or stop the tumor from growing.   "
120451|NCT01709279|"     Mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial     cell, vascular smooth muscle cell and will be useful for heart regeneration. Adipose tissue     is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this     trial, eligible ischemic heart failure patients will be proceeded intracoronary     administration of autologous adipose tissue derived stromal cells by cardiac catheterization.   "
120452|NCT01709266|"     Background:      The incidence of gastrointestinal infections is very high. In Western countries at least 30%     of the population suffers from at least one food-borne infection per year. Mostly because of     the problem of antibiotic resistance, more emphasis is put on prevention of infections. One     of the possibilities is to strengthen human resistance to gut infections by consumption of     probiotics. A specific blend of probiotic lactic acid bacteria (Lactobacillus helveticus     Rosell-52, Lactobacillus rhamnosus Rosell-11, Bifidobacterium longum Rosell-175) and a     probiotic yeast (Saccharomyces boulardii), improved stool consistency and shortened the     duration of diarrhea in a rat model of E.coli-induced diarrhea. These probiotics showed     synergistic effects compared with administration of solely S. boulardii or a mixture of L.     helveticus Rosell-52, L. rhamnosus Rosell-11, B. longum Rosell-175. Consumption of S.     boulardii and a combination of L. helveticus Rosell-52, L. rhamnosus Rosell-11 reduced     diarrhea in humans.      Aim:      To study whether probiotics improves the resistance of humans to enterotoxigenic E. coli     (ETEC).      Study design:      The PROTETEC study is a parallel, double-blind, placebo-controlled 4-weeks intervention with     probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs     placebo on several infection markers in response to an ETEC challenge is investigated.     Participants will be randomly assigned to the probiotic or placebo group (n=30 per group).     Subjects will be instructed to maintain their usual pattern of physical activity and their     habitual food intake, but to standardize their dietary calcium intake. After an adaptation     period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine     (strain E1392-75-2A; collection NIZO food research; dose 10E10 CFU). Before and after     infection, a diary will be kept to record all food and drinks consumption (2x2 days) to     assess the habitual dietary intake, as well as for daily recording of bowel habits and     frequency and severity of gastrointestinal complaints. The following biological samples will     be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces.     Blood is sampled for immune response analyses and the fecal samples are collected to quantify     several infection- and immune system markers, to determine probiotic excretion, and to verify     dietary calcium intake.      Study population:      Healthy males of 20-55 yrs of age.      Interventions:      Probiotics (capsules containing freeze-dried powder, probiotic dose per capsule 5x10E9 CFU;     twice daily) or placebo (capsules with carrier material powder of identical appearance)      Primary outcomes:      Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day).      Secondary outcomes:      Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal     complaints, relative fecal wet weight.      Tertiary outcomes:      sIgA and calprotectin in feces, probiotic persistence and levels of opportunistic pathogens     in the endogenous microbiota.   "
120453|NCT01709253|"     Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma   "
120454|NCT01709240|"     The purpose of this study is to assess the safety and performance of the BioWeld1 System     procedure for surgical incision closure of the skin in women scheduled for elective C-section     procedure.   "
120455|NCT01709227|"     Acute kidney injury (AKI) after cardiopulmonary bypass (CPB) in infants is common and     associated with poor outcomes. Peritoneal dialysis (PD) and furosemide have been used to     attain negative fluid balance due to AKI induced oliguria, but have not been compared     prospectively. The investigators will prospectively compare outcomes of infants with oliguria     after CPB randomized to PD vs. furosemide with the hypothesis that infants receiving PD have     superior outcomes.   "
120456|NCT01709214|"     The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to     placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the     knee. This study includes a maximum 21 day Screening Period followed by a 15-week     Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are     eligible for the Double-blind Treatment Period will be randomized to one of following     treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200,     300 or 400 mcg), oxycodone CR (Controlled Release) dose range (10, 20, 30, 40 or 50 mg) or     placebo.   "
120457|NCT01709201|"     The investigators goal is to pilot a substance use-related brief intervention (BI) for youth     with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability     and impacts of the approach for reducing substance use among this group.   "
120458|NCT01709188|"     The purpose of this project is to determine if the Musical Dual Task Training program     improves attention control that influences measures of gait performances under dual tasking,     balance, fear of falling, and behavioral disturbance in patients with mild to moderate     dementia. This Musical Dual Task Training protocol is structured with musical content and     patients are required to do musical tasks including singing and playing instruments     contingent on visual or auditory cues while walking. This paradigm is designed to include     music making because it involves great demands on attention and memory that might elicit     experience-dependent plasticity in the brain. Musical Dual Task Training is proposed to     strengthen brain networking for attention control that consequently may improve the gait     performances in patients with dementia, as indicated by reducing dual task cost on gait.   "
120459|NCT01709175|"     The purpose of this study is to compare once-a-week vs. twice-a-week strength training in     survivors of breast and gynecologic cancer to determine which is the optimal exercise     prescription.   "
120460|NCT01709162|"     The purpose of the study is to determine whether additional doses of ipilimumab have a     positive effect on survival in the treatment of advanced melanoma that has progressed after     successful initial treatment with ipilimumab.   "
120461|NCT01709149|"     The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357     when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic     Lateral Sclerosis (ALS).   "
120462|NCT01709136|"     Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant     recipients.   "
120471|NCT01709019|"     Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is     anticipated that some of the randomized study subjects may not complete the study; subjects     who withdraw or are discontinued, will not be replaced. Randomization will be stratified by     age (60 to <75 years and ≥ 75 years) in order to distribute the proportion of such persons in     each age group equally across treatment groups.      Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine     on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A     rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo     group on Day 28, the placebo group will receive saline. For each subject, study follow-up     will span approximately one year from the first immunization (on Day 0) for all subjects.   "
120581|NCT01707589|"     the investigators are assessing a non-invasive monitor based on dynamic light scattering that     measures pulse rate and respiration rate. The monitor also will be equipped with a     temperature sensor and a motion sensor. This monitor will allow multi-parametric measurements     in neonates in a simple and noninvasive manner.   "
120463|NCT01709123|"     6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the     devastating complications that result from poorly controlled diabetes. However, for many     patients, achievement of tight glucose control is difficult with current regimens. Trivalent     chromium, the form found in foods and dietary supplements, is believed to be safe. Our     preliminary studies have reported that chromium supplementation inhibits the increase in     pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and     IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly,     animal studies have shown that chromium niacinate supplementation lowered blood levels of     glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines     are proteins that are secreted by monocytes and other cells in response to various stimuli,     such as infection. Some of the cytokines are known to regulate insulin sensitivity and     elevated level of these cytokines in blood may accelerate clogging of arteries. Thus,     chromium supplementation may increase insulin sensitivity and glycemic control in diabetic     patients, and may prevent the development of cardiovascular disease in diabetic patients.     Given the enormous public health cost of diabetes, the prospect of being able to use a     relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in     achieving normal blood glucose level merits further study.      We will examine the effects of placebo and chromium niacinate supplementation on the fasting     glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic     patients. We will determine these above parameters at baseline and after the 1, 2 and 3     months of supplementation in diabetic patients. The long-term objective is to explore the     efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the     development of cardiovascular disease (CVD), and improve the life expectancy in diabetic     population.      Chromium supplements are widely used by the public and are available in many stores, such as     Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace     metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an     essential vitamin for our body. This study plans to use chromium niacinate, a complex of     chromium and niacin. Chromium niacinate is considered a nutrient.   "
120464|NCT01709110|"     The primary purpose of participation in this study is to answer whether teriparatide is     superior to risedronate in reducing the occurrence of new vertebral fractures during 24     months of therapy.   "
120465|NCT01709097|"     Background:      Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ     transplant. Patients need to take their prescribed medications and attend their appointments     with the doctor.      Based on previous studies in other European countries, the cost of non-compliance after organ     transplantation in Sweden is >SEK 35 million/year.      Patients who lose their graft both lose quality of life and have decreased expected survival;     moreover, retransplantation may be hampered by new HLA antibodies.      Question:      The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed     medication regimen in renal transplant patients.      Methods and materials:      All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given     information about the study and will then be asked to participate. Participants will be     randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included     patients will be closely monitored for 1 year regarding intake of prescribed medications.      Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each     occasion when the patient takes medications from the dispenser. It has a SIM card and text     messaging capabilities.      Addoz Portal™ is a web-based application that makes it possible to monitor and analyse     medication intake. Each event in the medication dispenser is registered in the portal, which     communicates with the care provider/support person by text message, e-mail or telephone.      Significance of the study:      In the future it may be possible to improve compliance in transplant patients. In particular,     patients will feel secure since they will receive confirmation through the portal that they     are taking their medications safely and accurately.   "
120466|NCT01709084|"     The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to     standard treatment) in terms of the percentage of patients who have plasma human     immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per     mL after 48 weeks of randomized treatment with tenofovir disoproxil     fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).   "
120467|NCT01709071|"     A new inactivated polio vaccine based on attenuated poliovirus strains was developed to     transfer the technology to manufacturers in low- and middle-income countries. This vaccine     was produced in different dosages and in different formulations. In healthy adults the safety     of the highest dose was comparable to that of the existing inactivated polio vaccine. The     purpose of this trial is to determine the safety of the different dosages and formulations of     the vaccine in infants. The second goal of this study is to analyse the immune response after     three doses in infants.   "
120468|NCT01709058|"     This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back     pain in subjects aged 65 or older. In particular, the intramuscular injection     technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to     intradiscal infiltration/intraforaminal technique, will be used.   "
120469|NCT01709045|"     The possibility to identify the risk of rupture of a carotid plaque will have tremendous     impact in clinical decision making. A vulnerable plaque is considered to have a large lipid     rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells,     intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to     validate imaging of plaque vulnerability with histology. Previous studies have evaluated the     use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation     between imaging and histology and/or clinical characteristics. However, they have focused on     single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography     (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small     cohorts      The primary goal of this study is to investigate whether there is a correlation between     neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic     contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the     correlation between the volume of the LRNC as determined by dual-energy CT and histology.      Secondly, the investigators will investigate the correlation between the volume of the LRNC,     the fibrous cap status and the volume of the calcifications determined by MRI versus     histology, the correlation between number of microembolisms and fibrous cap status and the     correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.      The imaging parameters showing good correlation with plaque vulnerability characteristics can     be used for further analysis in assessing the vulnerable plaque   "
120470|NCT01709032|"     We hypothesize that the combination treatment with deferasirox and deferiprone will be well     tolerated and will result in significant improvement in cardiac and liver iron levels.   "
120615|NCT01707147|"     The aim of this study is to monitor safety and efficacy of treatment with linagliptin in     Korean patients with type 2 diabetes mellitus in routine clinical settings.   "
120616|NCT01707134|"     This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of     insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.   "
120472|NCT01709006|"     It is currently estimated that above 50% of new cancer cases are diagnosed in the elderly     population[1]. With the increased life expectancy in the industrialised countries, the     incidence of head and neck cancers has significantly increased in the last decade with rates     estimated between 24-40% in patients over 70 years old [2-4]. It is estimated that with the     improvement in quality of life and treatment modulation, the incidence will continue to rise     in the coming years. Because the current available prospective studies often exclude patients     above 65 or 70 years old, the data and guidelines on head and neck treatment for these     patients population remain limited.      Treatment of elderly patients with advanced stage III-IV oropharyngeal squamous carcinoma     with intensity modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a     dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions to the first     disease-free lymphatic relay bilaterally as well as a combination Cisplatin chemotherapy at a     reduced dose.   "
120473|NCT01708993|"     The purpose of this study is to find out if giving reolysin in combination with docetaxel or     pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone.   "
120474|NCT01708980|"     Background:      In the early phase after a total knee replacement (TKA), patients experience multi-level     weakness in the operated leg, which is caused primarily by reduced central (CNS) activation     failure of the muscles - especially the knee extensors. This considerable loss of muscle     strength relates to reduced functional performance. The investigators recently reported that     early-commenced physiotherapy, including progressive strength training performed in machines,     seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the     operated leg, elicited during strength training in machines, can be reached during strength     training in more simple forms? Many clinicians are faced with the problem of not having     strength training equipment at their institution, or having to prescribe simple strength     training exercises for home-based training.      Purpose and hypothesis:      The purpose of this study is to determine which strength training exercises that activate the     muscles in the operated leg the most after TKA. The hypothesis is that strength training     exercises performed in machines is more effective compared to strength training performed in     more simple forms (using elastic bands or own body weight, etc.).      Participants and methods:      Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first     investigation, will be included. The participants are investigated twice. During the first     investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a     load that can be lifted exactly 10 times) will be determined for all the exercises. At least     72 hours later, the participants will undergo an electromyographic analysis, which determines     the neuromuscular activity of the thigh muscles in the operated leg.      Ethical issues:      From a pilot study, the investigators found that strength training exercises commenced early     after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain.     None of the financial supporters, or any of the authors, have any potential conflicts of     interest with regard to the study.   "
120475|NCT01708967|"     This study designed for compare efficacy of following two anesthetic method for transnasal     endoscopy        -  Catheter-free method        -  Catheter-insertion method   "
120476|NCT01708954|"     This randomized phase II trial studies how well giving erlotinib hydrochloride and     cabozantinib-s-malate alone or in combination works as second or third line therapy in     treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and     cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together     with cabozantinib-s-malate is more effective than erlotinib hydrochloride or     cabozantinib-s-malate alone in treating non-small cell lung cancer.   "
120477|NCT01708941|"     This randomized phase II trial studies how well ipilimumab with or without high-dose     recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that     cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor     growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the     growth of tumor cells. It is not yet known whether ipilimumab is more effective with or     without high-dose recombinant interferon alfa-2b in treating melanoma.   "
120478|NCT01708928|"     Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the     lower two thirds of the face and neck. Subjects will be equally grouped into those with a     history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or     rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment.     Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each     follow-up visit.   "
120479|NCT01708915|"     The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide     ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of     acute low back pain.   "
120480|NCT01708902|"     Reduced factorial design study with 24 week randomized treatment of initial combination     therapy with linagliptin and metformin in T2DM patients   "
120481|NCT01708889|"     The purpose of this study is to determine the effect of renal impairment on pharmacokinetics     (PK) of BMS-914143.   "
120482|NCT01708876|"     Preliminary studies have supported the background efficacy of local standard anti-malarial     medications in the treatment of uncomplicated knowlesi malaria, however this has not been     tested systematically and there are no current WHO treatment guidelines for this infection.     There are both health cost benefits to a more rapidly acting agent, and due to difficulties     with microscopic identification there may be more effective treatment for all malaria species     if an aligned treatment guideline could be supported. In addition, no therapeutic efficacy     monitoring of current first line anti-malarials used for the treatment of P. vivax malaria     have been conducted in Malaysia.      The investigators aim to test whether the fixed combination of artesunate-mefloquine is     superior to chloroquine in order to define the optimal treatment for both uncomplicated P.     knowlesi and P. vivax infection in both adults and children in this region.   "
120505|NCT01708577|"     The purpose of the study is to evaluate the feasibility of a new wearable computerised system     designed for an ongoing monitoring of sportsmen under real-life conditions. This system     consists of different sensors and Bluetooth Transmitters interconnected by wires and     integrated in the textile of a T-shirt. Several physiologic parameters including bioimpedance     should be investigated under conditions relevant for an intensive physical activity, like     high body temperature or partial dehydration. This system has to be tested under laboratory     and natural/open air conditions, the obtained evaluations compared with standardised     established diagnostic methods.   "
120506|NCT01708564|"     This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose     levels. The results will help identify the most optimal doses to take forward to the Phase     2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with     rhFVIIa.   "
124373|NCT01657773|"     The aim of this sudy is to investigate the prevalence of colorectal cancer (CRC) in patients     with nonalcoholic fatty liver disease (NAFLD) and evaluate whether NAFLD is a risk factor for     CRC.   "
120483|NCT01708863|"     Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that     consists of multiple obstructions to flow through the left heart and aorta, as well as     hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol     starting within days of birth. Stage I of this process is the Norwood reconstruction (within     the first few days of life), Stage II (usually required within 3-8 months) involves creation     of a direct connection between the patient's superior vena cava and the pulmonary arterial     confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan     circulation (typically within the first 2-4 years). This single ventricle approach requires     the right ventricle to perform as the only circulatory pump for the entire body.      Our long-term goal is to develop regenerative strategies to strengthen and augment the right     ventricular muscle of the single-ventricle heart following surgical palliation in HLHS     patients. To determine the safety and feasibility of a cell-based therapeutic intervention at     the Stage II surgery, we aim to document the natural history of post-surgical care in HLHS     patients having undergone standard of care with protocol specific follow-up over the course     of a 6-month period.      This prospective study will document the natural history in patients with HLHS after planned     Stage II surgical palliation with a focus on cardiovascular parameters within 6 months     following surgery in 10-20 patients.   "
120484|NCT01708850|"     Patients with cancer and an upper extremity DVT associated with a central venous catheter     (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates     with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes     including bleeding and recurrent venous thromboembolism.      The investigators hypothesize that anticoagulation with rivaroxaban in patients with UEDVT     secondary to central venous catheters in patients with active malignancy is an effective     therapy as quantified by the success of catheter preservation. Prolonged line salvage rate     without recurrence of UEDVT will improve the management of cancer patients who develop an     upper extremity deep venous thrombosis in the setting of a central venous catheter.   "
120485|NCT01708837|"     The purpose of this study is to investigate whether the depth of anesthesia with propofol     affects the incidence of early postoperative cognitive dysfunction   "
120486|NCT01708824|"     Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong     Kong. A recent report concluded physical activity (PA) protects against colon cancer and     foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of     lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is     largely unknown.      Objectives & hypothesis - Our study aims to evaluate the acceptability of two behavioural     interventions for CRC survivors intended to improve cancer outcome and designed to (1)     increase PA levels and (2) reduce consumption of a Western diet.      The investigators hypothesize that the proposed interventions are (1) efficacious in changing     the two targeted behaviours; and (2) acceptable to CRC survivors.      Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors     within 12 months of completion of cancer treatment and without evidence of     persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after     informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted     behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of     PA and dietary intake could be met at the end of intervention. Secondary outcome measures     include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants     of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of     theoretical constructs underlying PA and dietary interventions; (5) possible health benefits     and side effects (PA-associated injury and nutritional deficiency) arising from the     interventions. Outcome will be assessed at baseline, 6 months into intervention and then at     0, 6 and 12 months post-intervention.      Impact - If proven feasible, our intervention programme would pave way for a large randomized     controlled trial testing the effect of PA and diet on the treatment outcome of CRC.   "
120487|NCT01708811|"     Hyponatremia during labour has been associated with prolonged labour, and increased incidence     of instrumental delivery and emergency caesarean section. Sodium influx in myometral cells     are involved in contractility,and and influence of hyponatraemia on contractility can be     suspected.   "
120488|NCT01708798|"     Doxorubicin and other anthracyclines are commonly used to treat breast cancer and other types     of cancer. Unfortunately, they can cause heart muscle damage, resulting in scarring, abnormal     contraction and relaxation, and heart failure symptoms. This side effect occurs more     frequently at higher doses, and limits the total dose that can be given to cancer patients.     Eplerenone is an oral medication that prevents or reverses heart damage in other disease     states, and is commonly used to treat heart failure. This study will investigate the use of     eplerenone to protect the heart from these harmful side effects of doxorubicin.      Few therapies have been shown to prevent heart damage in patients receiving anthracyclines.     Small studies have suggested that other heart failure medications (ACE inhibitors,     beta-blockers) may reduce the incidence of cardiac toxicity, but eplerenone and other drugs     in its class (aldosterone antagonists) have not previously been studied. Eplerenone inhibits     enzyme pathways that cause scarring of the heart, and animal studies suggest that     anthracyclines cause damage through these same pathways.      This study aims to investigate whether eplerenone protects the heart from the harmful effects     of doxorubicin chemotherapy. Specifically, it will measure the effect that eplerenone has on     heart muscle relaxation. It will randomly assign women undergoing chemotherapy with     doxorubicin to one of two groups: one group will receive eplerenone, and the other group will     receive placebo (sugar) pills. The subjects will not know which type of pills they are     taking. Heart muscle relaxation will be measured at baseline, after completion of     chemotherapy (8-12 weeks), and after 6 months. There will also be various blood tests     measured in the study subjects, to determine whether there might be certain blood tests that     identify patients at particularly high risk of heart toxicity after doxorubicin therapy.   "
120489|NCT01708785|"     The purpose of this study is to optimize an obesity treatment program targeting overweight     8-12 year old children using Cue Exposure Training.   "
120490|NCT01708772|"     A total of ninety patients (52men and 38women) were included in the study. Forty five     patients developed septic complication during ICU stay (sepsis group). Forty five patients     were critically ill without evidence of infectious organism (SIRS group). At admission,     Patients data include clinical status; SOFA score; central venous pressure; laboratory     analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The     attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long     as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.   "
120491|NCT01708759|"     One hundred eighty critically ill African adult intensive care patients divided into two     groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic     critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and     SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.   "
120543|NCT01708083|"     Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing     laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).      Are there any difference in polymorphids and/or mRNA expression in genes significant for     developing obesity, between normal weight and obese individuals, with or without diabetes typ     2 .      Are there any difference in polymorphids and/or mRNA expression in different types of fat     tissue   "
124396|NCT01657474|"     The purpose of this study is to determine whether a weekly application of EpiFix human     amniotic membrane is more effective than a biweekly application (every two weeks) in the     treatment of diabetic foot ulcers.   "
120492|NCT01708746|"     This is a prospective, single-institution observational study to be conducted at 4 clinics     within the Southern California Permanente Medical Group. Pregnant women who present for     prenatal genetic counseling at the designated clinics and who meet study eligibility criteria     will be offered the option of the verifi® prenatal test by a trained, licensed and certified     genetic counselor (GC) . Women who elect the verifi® prenatal test will have a blood sample     drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited     clinical laboratory (Redwood City, CA). Results will be reported to the ordering health care     provider by the laboratory within 8-10 business days and will be shared with the subject by     their provider. Subject care and decision-making following NIPT result will be clinically     managed by the provider with his/her subject and is not dictated by the study protocol. All     eligible women who provide informed consent, whether they elect or decline NIPT will be asked     to complete a short questionnaire on their views of prenatal testing. The uptake of invasive     prenatal procedures (CVS and/or amniocentesis) by the total prospective cohort will be     collected through review of electronic medical records (EMR). A historical cohort with     matched demographic and pre-test indications to the prospective cohort will be identified     from the EMR for comparison in the primary analysis.   "
120493|NCT01708733|"     The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on     HCV Carrier With Abnormal Liver Function.   "
120494|NCT01708720|"     The purpose of this trial is to determine whether the new inactivated polio vaccine that is     based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy     adults.   "
120495|NCT01708707|"     The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost     effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence     Syndrome (NAS).   "
120496|NCT01708694|"     The purpose of this study is to determine the effect of a slowly digesting starch on gut     bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with     pre-diabetes.   "
120497|NCT01708681|"     Despite numerous studies of meal components in humans, little is still known about how     different meals influence on metabolism. The purpose of this study is to a gain knowledge of     how a balanced test meal with either lean seafood (example:cod) or meat as the main protein     source will:        1. affect the postprandial metabolism acutely (test-meal at beginning of the study)        2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at          end of intervention period)        3. affect gut microbiota composition   "
120553|NCT01707953|"     The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on     reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip     arthroplasty.   "
120554|NCT01707940|"     This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety     of BI 144807.   "
120498|NCT01708668|"     Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent     epidural injections appear to reduce the incidence of maternal intra-partum fever compared to     continuous epidural infusion during labor analgesia. However, the optimal combination of     bolus volume and administrating interval has not yet been compared. The purpose of this     prospective, randomized, double-blind trial was to determine how intermittent epidural bolus     reduced the incidence of maternal intra-partum fever compared with continuous epidural     infusion during labor.   "
120499|NCT01708655|"     The investigators hypothesize that measurement of beta adrenergic induced sweat rate using an     evaporimeter can accurately and reliably determine different levels of CFTR dysfunction     within a spectrum of patients expressing various degrees of cystic fibrosis disease.      The investigators overall goal is to determine whether the evaporimeter technique of     measuring beta-adrenergic induced sweat rate is capable of accurately and reliably     identifying different levels of CFTR dysfunction, as a prerequisite before advancing this     technique as biomarker assay into clinical trials.   "
120500|NCT01708642|"     The purpose of this study is to evaluate the effect of intraoperative administration of     low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.   "
120501|NCT01708629|"     The purpose of this study is to assess the safety and efficacy of brodalumab at two different     doses compared with placebo in participants with moderate to severe plaque psoriasis.      A second purpose of this study is to assess the safety and efficacy brodalumab at two     different doses compared with ustekinumab in participants with moderate to severe plaque     psoriasis.      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens     of brodalumab.   "
120502|NCT01708616|"     This single-center, randomized, double-blind, two-period crossover study will evaluate the     safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of     multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects     will be randomized to one of 4 treatment sequences of two periods to receive multiple doses     of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of     RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout     period of approximately 3 weeks between treatment periods. Anticipated time on study is up to     12 weeks (from screening through study completion).   "
120503|NCT01708603|"     The purpose of this study is to assess the safety and efficacy of brodalumab at two different     doses compared with placebo in participants with moderate to severe plaque psoriasis.      A second purpose of this study is to assess the safety and efficacy brodalumab at two     different doses compared with ustekinumab in participants with moderate to severe plaque     psoriasis.      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens     of brodalumab.   "
120504|NCT01708590|"     The purpose of this study is to assess the safety and efficacy of brodalumab taken every two     weeks at two different doses in participants with moderate to severe plaque psoriasis.      A second purpose of this study is to assess the safety and efficacy when brodalumab is     replaced with placebo in some participants compared with the participants who are still     receiving the brodalumab.   "
120625|NCT01707017|"     The purpose of this study is to compare the impact of high- and low-intensity resistance     exercise on force-velocity characteristics, muscle mass and inflammatory processes in older     adults. As all training protocols are designed to end with maximal effort, effects are     expected to be similar between groups.   "
120507|NCT01708551|"     Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in     Groups A, B or C will undergo axillary punch biopsies during the course of the trial to     determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm     and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A     and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will     receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment     depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol     amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy     setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40     lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days     post-treatment #2.   "
120508|NCT01708538|"     The corneal collagen cross-linking treatment has been used with increasing success to treat     corneal dystrophies such as keratoconus. Recent advances have allowed different techniques     for performing this cross-linking treatment. This study investigates the effects of corneal     cross-linking using different surgical techniques.   "
120509|NCT01708525|"     Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in     tissue treated with the Ulthera® System compared to control tissue.   "
120510|NCT01708512|"     All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained     pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects     will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.   "
120511|NCT01708499|"     Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits     will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment,     immediately post-treatment, and at each follow-up visit.   "
120555|NCT01707927|"     Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta.     The investigators are looking at EOA and the Pressure Gradients over the valve by patients     with the same annulus measured by a hegar dilatator.   "
121374|NCT01697215|"     To evaluate the ability of the SonarMed AirWave to provide clinicians with information that     enables them to confirm continuous proper placement of the endotracheal tube. This initial     study is prospective, observational, looking at CXR results, and comparing those to AirWave     system output data.   "
120512|NCT01708486|"     Patients' satisfaction with their asthma medication devices is usually decided by using     properly designed questionnaires. These questionnaires are to be used to evaluate patients'     opinion, which is considered very important for the selection of a device.      The Feeling of Satisfaction with Inhaler (FSI-10) is a self-completed questionnaire designed     to assess the patient opinion regarding the satisfaction and usability of the inhalers     irrespectively of the drug used. It consists of 10 question each with 5 possible responses on     a 5-point Likert scale scored from 5 to 1, respectively. The total score can range between 10     and 50. The higher the score, the higher the feeling of patient satisfaction from the     inhaler.   "
120513|NCT01708473|"     This study will compare the effectiveness of two pain medications for reducing discomfort     during an Ultherapy treatment.   "
120514|NCT01708460|"     Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to     one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90     and 180 days post-treatment. Study images will be obtained pre-treatment, immediately     post-treatment, and at each follow-up visit.   "
120515|NCT01708447|"     This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for     reducing discomfort associated with Ultherapy™ treatment.   "
120516|NCT01708434|"     Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30     subjects will be enrolled. Study photos will be obtained prior to study treatment,     immediately following study treatment, and at each post-treatment follow-up visit. Follow-up     visits will occur at 90 and 180 days post-treatment.   "
120517|NCT01708421|"     The purpose of this study is to examine the phenotypic and genotypic characteristics and     their associations with symptom clusters experienced during treatment for childhood leukemia.   "
120518|NCT01708408|"     The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a     large-scale community registry and biorepository that can be used as a vehicle for future     health services, epidemiologic, clinical trials and other omics-related research.   "
120519|NCT01708395|"     The investigators believe that patients with ulcerative colitis are able to report details of     their own medical history accurately and record changes in clinical status effectively over     time. Using an internet-based database the investigators will ask patients to report their     own disease history, and the investigators will compare their reports to the medical record.   "
120520|NCT01708382|"     Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on     the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will     be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.   "
120521|NCT01708369|"     The purpose of this study is to determine if alcohol is able the affect the body's ability to     eliminate two commonly used medication, oseltamivir and aspirin. We hypothesize that drinking     alcohol may reduce the body's ability to break down these two medications along with many     others.This could affect the amount of drug in the blood which could impact how well these     drugs work and whether patients have side effects.   "
120544|NCT01708070|"     Although depressive and anxious symptoms are common in asthma patients and are associated     with worse clinical and resource utilization outcomes, there have been no studies focusing on     the particular challenges of improving asthma self-management in this population. The     investigators hypothesize that a tailored intervention to improve asthma self-management in     patients with a known history of depressive and anxious symptoms will be effective in     improving asthma-related quality of life.   "
120545|NCT01708057|"     This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the     bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active     comparator.   "
120546|NCT01708044|"     To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with     type 1 diabetes on postprandial plasma glucose concentrations   "
120522|NCT01708356|"     Introduction: Cycling is currently promoted at the municipal, provincial and national level     as a form of active transportation that increases physical activity while at the same time     reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions.     While at a population level the health benefits of exercise via cycling are estimated to     substantially exceed any health impacts related to air pollution exposure and injuries from     traffic accidents , cyclists are known to experience elevated exposures to traffic-related     air pollutants. Combined with exposure to elevated concentrations of air pollutants, cyclists     also are subject to substantially increased inhaled doses due to their level of exertion and     consequently increased inhalation rate. Therefore, given that cyclists experience exposures     to relatively high concentrations of traffic-related air pollutants and that their inhalation     of these pollutants is increased, it is important to evaluate the potential health impacts of     this scenario. Research on the potential health impacts related to exercise (cycling) and     urban air pollution exposure can help inform public communication strategies related to air     quality and its health impacts. In addition, as our previous work suggests substantial     variability in air pollution exposures to cyclists that is related to the route type and the     levels of traffic along cycling routes, there is potential for transportation planners to     promote increased cycling by enhancing infrastructure while at the same time developing     routes that also minimize exposure to air pollution. The cyclist population is also     interested in information regarding the air pollution exposures and potential health impacts     related to cycling.      The objective of this study is to investigate the relationship between traffic-related air     pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists.     Specifically, the investigators propose to:        1. determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10,          ultrafine particulate, black carbon) while cycling along two different bicycle routes in          the city of Vancouver;        2. estimate the pollutant dose received by each cyclist, and relate this to the health          effects observed; and        3. determine if there is a change in lung function, endothelial function, and C-reactive          protein level related to the level of air pollution exposure and dose   "
120523|NCT01708343|"     To test the hypothesis that the effect of either multiple deep intramuscular stimulation     therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep     intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a     placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for     improving pain relief, sleep quality, and physical and mental state of the patient.   "
120524|NCT01708330|"     When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy,     missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She     is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and     often painful procedure. Minimizing the pain during this procedure must not be overlooked.     There have been no randomized controlled trials evaluating pain control during MVA for     nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective     abortion or other office procedures.      Women being treated at the Women & Infants Triage who have experienced a first trimester     missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and     are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this     study. Those who wish to participate will be randomly assigned to treatment with lidocaine     gel or a placebo gel applied to the cervix during their procedure.      The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.   "
120525|NCT01708317|"     The purpose of this study is to determine if an Audio-enhanced Computer-Assisted     Self-Interview (ACASI) will lead to increase testing for sexually transmitted infections in     youth visiting a pediatric ED   "
120556|NCT01707914|"     Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and     cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous     animal studies from us and other investigators, anthocyanins have been shown to ameliorate     dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study     was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on     levels of biomarkers related to antioxidant status in young adults with features of fatty     liver disease.   "
120526|NCT01708304|"     The University of Washington's Northwest Research Group on Aging is partnering with Area     Agencies on Aging (AAA) in Washington and Oregon to complete this translational investigation     of RDAD (Reducing Disabilities in Alzheimer's Disease). RDAD is an evidence-based program     with demonstrated efficacy in helping older adults with dementia maintain physical function     and remain physically and mentally healthy. This study asks two questions: 1) Can AAA     partners successfully translate and implement RDAD, and 2) Is AAA implementation of RDAD     effective in producing desired outcomes among agencies, providers, and older adults with     dementia and their family members. This study is being conducted in Washington and Oregon     states.   "
120527|NCT01708291|"     This project will measure baseline stress among a group of youth in foster and kinship care.     The investigators will implement a pilot program to target stress reduction by using an     evidence-based group therapy technique teaching mindfulness skills. The investigators     hypothesize that the mindfulness skills will help youth to reduce stress, which will be     measured using psychological and physiological techniques.   "
120528|NCT01708278|"     Chronic obstructive pulmonary disease (COPD) is a progressive disorder of the lung parenchyma     and airways, which is the third-leading cause of death in the USA. Current therapies for COPD     are only partially effective and may also have side effects. Although increasing evidence     indicates that quercetin supplementation may be beneficial in treating COPD, key     methodological issues have not been resolved. The overall objective of this study is to     determine the dosage of quercetin supplementation, bioavailability of quercetin, safety,     dose-response relationship and appropriate biomarkers which reflect clinical outcomes in     patients with COPD that is necessary for conducting large clinical trials in this patient     population.   "
120529|NCT01708265|"     The purpose of this study is to compare early mitral valve repair versus a watchful waiting     strategy in asymptomatic patients with severe organic mitral valve regurgitation and     preserved left ventricular function.   "
120530|NCT01708252|"     Up to 10 subjects will be enrolled. All subjects will receive an increased density     UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face     and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be     obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.   "
120565|NCT01707797|"     The study aims to develop a questionnaire that can be used to help uncover a child's risk of     developing dental caries (also known as tooth decay or a cavity). The aim is to develop a     practical and easily-scored risk tool that a primary medical care provider can use to help     find young children with the highest risk for developing cavities.   "
120668|NCT01706458|"     This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic     acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded     to previous treatment with hormones and has spread to other places in the body. Vaccines may     help the body build an effective immune response to kill tumor cells. It is not yet known     whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in     treating prostate cancer.   "
120531|NCT01708239|"     In pregnant women with suspected DVT, a sure diagnosis is mandatory. In non-pregnant     patients, sequential diagnostic strategies based on 1) the assessment of clinical     probability, 2) D-dimer measurement and 3) compression ultrasonography (CUS) have been well     validated.      Clinical probability assessment by clinical prediction rules (CPRs) is a crucial step in the     management of suspected DVT. However, the most commonly used CPR for DVT, the Wells' score,     has never been validated in pregnant women. Recently, the 'LEFt' clinical prediction rule was     derived and internally validated. A prospective validation of this rule is now warranted, and     we plan to use it in our prospective study.      The second step used in the diagnostic strategy including non-pregnant patients is D-dimer     measurement. The test has been widely validated in non-pregnant patients and, in association     with a non-high clinical probability, it allows to safely rule out DVT.      As D-dimer level raise steadily during pregnancy, the specificity of the test decreases and     it is less useful in pregnant women. Data from the literature clearly suggest that the usual     cut-off set a 500 ng/ml would safely rule out DVT in pregnant women [6]. As the usual cut-off     has never been prospectively validated in pregnant women with suspected DVT, we would like to     use it in our study.      Some studies suggested that complete CUS is safe to rule out DVT in pregnant women. However,     this test is not always available. Therefore, a strategy in which the association of clinical     probability assessment and D-dimer measurement would allow to safely rule out DVT in a     significant proportion of patients without performing a complete CUS, would be of great help     in everyday clinical practice and would probably be cost-effective.      Therefore, we plan a prospective study to assess the safety of a sequential diagnostic     strategy based on the assessment of clinical probability with the LEFt rule, D-dimer     measurement and complete CUS in pregnant women with suspected DVT.   "
120532|NCT01708226|"     Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues     significant concurrent and long-term risk to affected youth. Although empirically supported     psychosocial and pharmacological treatments for OCD exist, many children and their families     are not able to adequately access these treatments or derive only partial benefit from them.     Such findings highlight the importance of developing more effective treatment options which     have the potential to be widely accessible to OCD youth.      The investigators are proposing to test a computerized attention modification program, AMP,     in six youth with OCD in an open case series to gather information regarding protocol     acceptability, feasibility and preliminary efficacy. This phase includes the development and     refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP     parameters for use with children.      Following ascertainment of study eligibility, participants will undergo a baseline assessment     consisting of a clinical interview, neurocognitive assessments, EEG, attention bias     assessment, and self report questionnaires. Study participants will then receive 12 sessions     of AMP treatment over the course of three weeks. All youngsters and their families will be     reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours     over the course of six weeks. Participants who are treatment responders may be asked to     return approximately 3 months after completing treatment for a follow-up assessment.      Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to     administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom     severity.   "
120533|NCT01708213|"     The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as     determined by clinical assessment of treatment sites and routine tracking of adverse events.   "
120534|NCT01708200|"     This study will compare the effectiveness of a psychoeducational memory program versus a     computerized memory program in individuals with mental illness. Although improvements are     expected with both form of interventions, we do not know which will provide maximal benefit     in this population.   "
120535|NCT01708187|"     Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all     flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal     tendon gliding is key to their function as effective plantar flexors and evertors of the     hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction     at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for     standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal     adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing     Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft     will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic     Membrane in conjunction with a peroneal tendon repair will decrease that amount of     inflammation, overall recovery time of surgically repaired peroneal tendon tears, and     adhesions.   "
120536|NCT01708174|"     This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric     patients with Hh-pathway activated, relapsed MB.   "
120537|NCT01708161|"     This is a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part is to     estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the     combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the     clinical efficacy and to further assess the safety of the combination in selected patient     populations. Patients will be treated until progression of disease, unacceptable toxicity     develops, or withdrawal of informed consent, whichever occurs first. All patients will be     followed up. At a minimum, patients must complete the safety follow-up assessments 30 days     after the last dose of the study treatment.   "
120538|NCT01708148|"     The aim of this study is the improvement of the penile linked neovaginal flora in     male-to-female transsexuals after application of oral probiotics.   "
120539|NCT01708135|"     This current study aims to evaluate the efficacy of engagement modules in preparing patients     for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app     (Android and Apple compatible) has been created that will assist in both educating and     engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to     create a cost-effective, smartphone-based platform that serves to not only efficiently     educate but to also verify competence and keep our patients engaged during the lengthy     pre-bariatric surgery process.   "
120540|NCT01708122|"     The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl     spray to decrease the pain during cystoscopy (the passage of a telescopic instrument into the     bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any     other problems with the urinary bladder). The current standard practice is to use Lidocaine     jelly (a local anesthetic) given through the urethra to lubricate and decrease pain. In this     study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after     the above procedure.   "
120541|NCT01708109|"     The purpose is to study natural process of gallstones in common bile duct, stones less than     or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The     second outcome is to study side-effects of gallstones removed with surgery.   "
120542|NCT01708096|"     The aim of the study is to develop new strategies in treatment of continuous increasing     number of patients with type 2 diabetes by understanding how bariatric surgery cures or     improves this condition.   "
120547|NCT01708031|"     Computerized Mental Arithmetic Task Based Human Stress Level Detection Using Physiological     Signal      The objective of this study is to induce and measure the human stress level through     computerized mental arithmetic task and multiple physiological signals (ECG, EMG, GSR, and     skin temperature). Studies suggested that mental arithmetic task is one of the efficient     stimuli to induce the stress. Hence, this mental arithmetic task protocol has been improved     in to computerized version. The protocol will be tested with normal subjects and multiple     physiological signals will be acquired simultaneously. The questionnaire about the subject     experience will be obtained in order to strengthen the stress induction. The normal volunteer     subjects will be invited for the participation this study. The physiological signal will be     analyzed using suitable algorithm based on the characteristics of each signals. The multiple     signal based stress level assessment system will be developed by training and testing the     acquired data.   "
120548|NCT01708018|"     This study will be the first scientific approach to investigate physical and psychological     effects of the passive hydrotherapy-method WATSU (WaterShiatsu) on women and their unborn     children at the third trimester of pregnancy. Potential therapeutic benefits of the method     shall be evaluated.      It is being hypothesized that WATSU is related to measurable changes in everyday stress     perception, psychological wellbeing, quality of life, pregnancy-related low back pain, tonus     of the uterus, amount of amniotic fluid, spontaneous course of breech presentations,     prospects of external cephalic versions.      Participants in the intervention-group will be treated twice with WATSU (60 minutes per     treatment, standardized sequence) in the >36th week of pregnancy. There will not be any     sham-intervention in the control-group. Both groups will be examined by ultrasound (prior and     after the treatments plus on day 8 of the trial) and answer questionnaires (prior and after     the treatments plus once a week until birth).   "
120549|NCT01708005|"     The purpose of this study is to compare the effect after 12 weeks of the oral intake of     Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive     performance in Trial Making Test score part B (this test evaluate executive functions of     mental flexibility) in older adults with Mild Cognitive Impairment (MCI).   "
120550|NCT01707992|"     This is a multinational, multicenter, randomized, double-blind, parallel-group,     placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and     tolerability of two doses of oral administration of laquinimod in subjects with RRMS. . The     study has periods: Period 1, the double-blind, placebo-controlled period (up to 24 months)     and Period 2, the active treatment period (24 months).   "
120551|NCT01707979|"     The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR     and impedance.   "
120557|NCT01707901|"     A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal     pain hypersensitivity in patients with gastric reflux disease   "
120559|NCT01707875|"     Fetal brain asymmetry is considered a normal developmental processes. The size and shape of     the lateral ventricles are interdependence with the brain parenchyma. Abnormal development of     the fetal brain may cause unilateral or bilateral ventriculomegaly. Fetal cerebral ventricle     measurement is one of the most frequently used sonographic tool for the evaluation of brain     development. It is easier to evaluate and measure the distal cerebral ventricle, and     therefore data concerning the normal range of asymmetry and the normal progress of the     asymmetry are limited.      The objective of the study is to follow up the incidental finding of fetal ventricle brain     asymmetry between 19-30 weeks of pregnancy.   "
120560|NCT01707862|"     Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle     tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least     70 cases. Most are individual case reports. Surgical experience is not much. However,     different opinion of surgical strategies remain controversial. The purpose of this report is     to describe our experience of surgical management for the IVL with intracardiac extension.   "
120561|NCT01707849|"     Background:      Hepatitis C recurrence, which invariably occurs in viremic liver transplant (LT) recipients,     associated with accelerated liver fibrosis leading to established graft cirrhosis in 40-20%     of patients in 5 years with another 5% experiencing an aggressive form with cirrhosis and     graft loss in 1 year. Since treatment after LT has a low efficacy, the overall survival of     HCV-infected LT recipients is shorter than that of uninfected LT patients.      New immunosuppressive agents such as mTOR inhibitors (Everolimus/Sirolimus) reduce the risk     of liver graft rejection, have antifibrotic properties and do not worsen HCV recurrence.     Moreover new directly-acting antiviral agents have increased efficacy of interferon-based     treatment but their use in LT recipients may be limited by side effects.      Hypothesis:      Use of individualized immunosuppressive regimen and early personalized anti-viral treatment     based on recipient and viral factors would improve outcome of HCV infected liver transplant     recipients.      Objectives:        1. To evaluate safety and efficacy of two steroid-free immunosuppressive regimens to reduce          hepatitis C recurrence associated to fibrosis progression (F≥2 under ISHAK score) at one          year post-transplant.        2. To identify viral and recipient factors associated with liver fibrosis progression using          ultra-deep pyrosequencing (UDPS).   "
120562|NCT01707836|"     This study will analyze DNA samples to determine associations between maternal and offspring     genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type     1. Participating families (mother, father, child) will be asked to complete a short     questionnaire and provide DNA samples (either saliva or blood). The information gained from     your participation may one day help doctors develop strategies to reduce brain tumor risk in     individuals with NF1. Please note: there is no therapy associated with this study.   "
120563|NCT01707823|"     This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with     stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients     with cancer in the laboratory may help doctors learn more about changes in biomarkers that     occur during treatment with acetylsalicylic acid   "
120564|NCT01707810|"     METHODS: Patients were submitted to conventional (n=15) or piggyback (n=17) liver     transplantation (LTx). Free hepatic vein pressure (FHVP) and the central venous pressure     (CVP) measurements were performed after graft reperfusion. Postoperative (PO) serum     creatinine (Cr) was measured, acute renal failure (ARF) was defined as Cr > or = 2,0mg/dL and     PO renal function was analyzed by modificated RIFLE-AKIN. PO overall Cr was calculated by     area under the curve (AUC) of Cr vs. time. on the first week.   "
120566|NCT01707784|"     The objective of the study is to investigate the effect of stress on glucose tolerance during     pregnancy.      The main objectives of the study are to investigate if various measures of stress (stressful     life events, the perceived level of stress and the cortisol or copeptin concentrations)     differ between pregnant women with and without gestational diabetes during the end of the     second/beginning of the third trimester when presenting for their routine glucose tolerance     testing.      Secondary objectives are the link between these different stress measures and the routinely     measured fasting and stimulated glucose levels during the oral glucose tolerance test.   "
120567|NCT01707771|"     Objective: to assess the effect of gastric bypass on HDL-cholesterol concentration and its     Apolipoprotein A4 content at 1 year following bariatric surgery in comparison with a     hypocaloric diet. Secondary aim was to measure total cholesterol and triglycerides levels as     well as insulin sensitivity after interventions.      Summary Background Data: Very few prospective uncontrolled studies have investigated the     effects of Roux-en-Y gastric bypass (RYGB) on cardiovascular risk factors. No controlled     studies had as primary goal the changes in HDL-cholesterol after gastric bypass.      Methods: Forty subjects with a BMI>40 or ≥35 kg/m2 in the presence of diabetes were enrolled.      Twenty of them were operated of RYGB while 20 received lifestyle modification suggestions and     medical therapy for obesity complications (diabetes, hypertension and hyperlipidemia).   "
120568|NCT01707758|"     The primary objective is to develop a rapid in vitro screening assay for detection of     pancreatic cancer biomarkers in blood of patients with pancreatic cancer.   "
120569|NCT01707745|"     Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In     retinopathy of prematurity (ROP).      Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.   "
120594|NCT01707420|"     The typical post-operative course for children following surgical removal of their tonsils     and adenoids can be challenging, especially for pain control. First line medications for pain     include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory     drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be     short-lived. Gabapentin has been shown in adult studies to tone down the body's response to     pain and decreases opioid use post-operatively. The purpose of this study is to see if a     single preoperative dose will reduce post-operative pain scores and the amount of analgesic     used.   "
120570|NCT01707732|"     Venous thromboembolism (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE) is a     common medical condition encountered during hospitalization in a medical environment. The use     of thromboprophylaxis with Low Molecular Weight Heparin (LMWH) or fondaparinux has reduced     more than 50% relative risk of thromboembolic complications.However, while obesity defined by     a body mass index (BMI) greater than 30 kg/m2, is a major risk factor for venous thrombotic     events, data on obese patients are limited. In fact, less than 20% of patients included in     the three major studies of preventive medicine had a BMI ≥ 30 kg/m2 and most studies specific     to the obese population comes from a series of bariatric surgery patients or orthopedic     surgery. The main results of this series show regarding the obese population a decrease of     the anti-Xa activity during the administration of a standard dose of enoxaparin (40 mg / d).     However, no specific recommendation in this population has not been published to date and     therefore,the dosages currently used are the same regardless of the patient's weight. In this     context, the use in obese patients hospitalized in a medical environment a stronger dosage of     enoxaparin (60 mg / d) compared to the standard dose of 40 mg / day, could get rates anti-Xa     activity levels more consistent with the treatment required, and thus reduce the risk for     thromboembolic complications in these patients   "
120571|NCT01707719|"     High lipid peroxidation and altered antioxidant defenses have been frequently reported in     Alzheimer's disease patients.      The purpose of this study is to investigate susceptibility to photo-oxidation of isolated     erythrocyte membranes, in patients affected by Alzheimer's disease and age- and sex-matched,     non demented subjects.   "
120572|NCT01707706|"     The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment     on residual insomnia in major depressive patients.   "
120573|NCT01707693|"     Making physical activity an integral part of daily life is imperative to the health and     well-being of our nation's older adults. However, no intervention strategy to encourage daily     physical activity for older adults, especially older women, has been effective. This     feasibility study will test a multi-tailored motivational intervention to increase usual     lifestyle physical activity of older sedentary women to reduce their coronary heart disease     risks.   "
120574|NCT01707680|"     The purpose of this study is to determine whether the use of different sedatives affect the     weaning process from mechanical ventilation in intensive care patients.   "
120575|NCT01707667|"     To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor     activity in subjects that are chronically constipated.   "
120576|NCT01707654|"     A combination of soft tissue and digital nerve defects in the finger results in sensory loss     of the finger pulp. Reconstruction of these combined injuries is difficult. When the     neurocutaneous defect is associated with wound infection, reconstructive alternatives are     more limited. From July 2008 to May 2010, a retrospective study was conducted with 9     consecutive postinfection patients who had the neurocutaneous defect of the finger following     trauma. The purpose of this retrospective study is to report repair of the complicated     infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of     this technique.   "
120577|NCT01707641|"     Oral mucositis is a debilitating side effect for oncology patients and there is a clear need     for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a     potential new alternative for the prevention of grade III and IV mucositis. The main endpoint     of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of     grade III and IV mucositis as well as increase the percentage of patients who will complete     the radio-chemotherapy treatment.   "
120578|NCT01707628|"     The purpose of this study is to compare the number of responders to vaccination with the     influenza virus vaccine at different time points after last dose of rituximab in patients     with lymphoma. Secondly to study the immune-response to vaccination with influenza virus     vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.   "
120579|NCT01707615|"     The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical     use   "
120582|NCT01707576|"     The primary purpose is to estimate the prevalence of depression and subsyndromal states among     adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they     are another way of tracking this suffering, as they host many troubled teens at once for     health problems and accidents sometimes iterative, reflecting their risk behaviour.      Secondary purposes are to assess the feasibility and desirability of a post-emergency medical     consultation for adolescents who scored high on a self-administered questionnaire, and to     assess the impact of this approach by later monitoring.   "
120583|NCT01707563|"     Marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in     the fibrillin-1 gene (FBN1). Penetrance of FBN1 mutations is complete but intra and inter     familial clinical expressivity is extremely variable. The underlying mechanisms for     variability are not understood. An interesting mechanism is that the expression level of the     wild type and/or mutated allele may play a role in the determination of variability.      Principal objective: To evaluate in Marfan patients, if FBN1 expression level (non-mutated or     mutated allele) modulates the clinical expression of the disease.      Judgment criteria : Correlation allelic expression level-phenotype Perspectives : To search     the predictive factors of severity in order to ameliorate precocity of taking care.   "
120584|NCT01707550|"     This observational survey study will capture all renal transplant patients in Serbia who are     currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive     protocol.   "
120585|NCT01707537|"     To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in     Healthy Adult Men   "
121375|NCT01697202|"     To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and     which factors that may influence the fatigue.   "
120586|NCT01707524|"     The aim of this study is to measure radiation exposure during coronary angiography (CA) with     a trans-radial approach (TRA), specifically comparing access via the left versus right radial     artery in patients with suggested clinical predictors of TRA failure/difficult. These     predictors include age >70, female gender, height <64 inches, and history of hypertension.The     study also aims to determine difficulties encountered during left or right radial access in     this specific patient population. A secondary aim is to compare the results of enrolled     patients with a registry of patients where femoral access was obtained.      Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the     United States annually. There is a growing trend to perform procedures utilizing the TRA due     to recent data demonstrating decreased bleeding and access-site complications compared to the     femoral approach. However, the TRA approach is also know to be associated with greater     radiation exposure compared to the femoral approach. Furthermore, the TRA to catheterization     may be difficult in certain populations because of anatomic considerations. Though     traditionally completed via canalization of the right radial artery (RRA) due to feasibility     with room setup, left radial artery (LRA) access may be superior due to the shorter distance     needed to reach the ascending aorta and bypassing the tortuosity of the right subclavian     artery. Given the benefits of the TRA, it is important to determine how left versus right     radial artery access affects parameters of radiation exposure in addition to procedural     difficulty.      This study will be a prospective, randomized study of patients with suggested predictors of     TRA failure/difficulty referred for coronary angiography. Patients referred for coronary     angiography using the trans-radial approach will be randomly assigned to obtain arterial     access via the right or left radial artery. A registry of patients referred for coronary     angiography using the trans-femoral approach will be compiled. The primary outcome measure     will be radiation exposure as measured by dose area product output from the coronary     angiography system. Secondary measures will include the total fluoroscopy time, total dose of     radiation, number of catheters used, and incidence of subclavian tortuosity. In addition,     procedural complications and success rates will also be evaluated.   "
120587|NCT01707511|"     Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value     of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between     Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient     and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure     values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also     investigated.   "
120588|NCT01707498|"     This is multi-center prospective randomized trial evaluating the effectiveness of a new     brain-computer interface for communication of quadriplegic patients in a clinical context.     This performance of this will compared to traditional assistive technology (scanning system)     and to performance of a healthy volunteer population.   "
120589|NCT01707485|"     This study will investigate the feasibility of testing whether a 5-day course of antibiotics     is as effective as a 10-day course for the treatment of uncomplicated community-acquired     pneumonia (CAP) in children. To accomplish this, previously well children aged 1-10 years who     present to McMaster Children's Hospital (MCH) emergency department (ED) with CAP will, if     they consent, be randomly chosen to be given either a 5 day or 10 day course of amoxicillin.     Neither the child, the child's caregiver, nor the researchers will know whether the child is     in the 5- or 10-day antibiotic group. Once the child has received the medication and for two     weeks after that, caregivers of children will be asked to complete a daily symptom diary for     their child, and will come to MCH at the end of the two week period (between day 14-18) to be     assessed by one of the researchers. This information will then be used to compare both groups     of children to determine if a 5 days of treatment is non-inferior to 10 days. The     investigators hypothesize that running such a trial is feasible.   "
120590|NCT01707472|"     This is an open label, exploratory study of simtuzumab (GS-6624) in adults infected with HIV,     hepatitis C virus (HCV), or co-HIV/HCV with histological evidence of liver fibrosis.     Participants will receive simtuzumab 700 mg intravenously every 2 weeks for a total of 24     weeks (12 infusions) while continuing on standard therapy for HIV (HIV-infected subjects     only).   "
120591|NCT01707459|"     This prospective, multicentre, observational study aims to test pre-operative platelet     function when taking anti-platelet medications. The investigators are using a simple bedside     blood test called Thromboelastography (TEG) and Platelet Mapping Assay (PMA). The     investigators will then follow the patient throughout their hospital stay for any major     cardiac complications (MACE) after surgery (peri-operative). The investigators hope to     determine if there is an association between how well platelets were inhibited by these drugs     before surgery and MACE during the perioperative period, 30 day, and one year follow-up.     Also, the response of various people to anti-platelet medications and their chances of     getting a major adverse cardiac outcome are determined by their genetic makeup. The     investigators will try to determine if certain genes are associated with higher cardiac risk.      Hypothesis: In patients who had percutaneous coronary intervention (PCI) and are undergoing     non-cardiac surgery (NCS) major adverse cardiac events (MACE) are associated with inadequate     platelet inhibition.   "
120961|NCT01702636|"     The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast     extravasation on computed tomography angiography, the spot sign, have lower rates of     haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared     to placebo.   "
120592|NCT01707446|"     Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a     serious complication that results in prolonged length of stay, increased health care costs     and is associated with higher death rates. The exact cause involved in the development of     delirium after cardiac surgery is unclear. The latest advancement in near-infrared     spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury.     This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery,     recording oxygenation in real time allowing the clinical team the opportunity to intervene     early to prevent ischemia and possibly preventing untoward events. Adverse events followed     include, but are not limited to, stroke, (transient ischemic attacks), heart attack,     (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure,     pneumonia, cause of death for 30-days after surgery (all cause mortality).      Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in     lower delirium rates after complex cardiac surgery.   "
120593|NCT01707433|"     BACKGROUND/OBJECTIVE: Quantitative urine screening for mucopolysaccharides (MPS) has been the     primary method for detecting mucopolysaccharidoses in children. This method may not be     sufficiently sensitive and may miss some patients with arylsulfatase B (ARSB) deficiency.     Investigators propose to identify patients retrospectively and prospectively who carry a     diagnosis of spondyloepiphyseal dysplasia, multiple epiphyseal dysplasia, bilateral proximal     femoral epiphyseal dysplasia, or bilateral Legg-Calve-Perthes. For these patients,     investigators will perform enzyme testing on a blood sample which will identify MPS VI or     IVA.      Patients who have an earlier diagnosis of MPS are likely to have better health outcomes with     medical management. Therefore, it is important to determine effective diagnostic methods.     Investigators believe that bilateral hip involvement should alert the clinician to the     possibility of MPS VI and further examination. The purpose of this study is to test the     hypothesis that the correct diagnoses of two MPS storage disorders are delayed in patients     with bilateral proximal femoral epiphyseal dysplasia and normal quantitative urine MPS     studies.   "
120595|NCT01707407|"     1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp          inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects.        2. To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor          ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with pomalidomide alone in          healthy male subjects.        3. To assess the PK of pomalidomide administered with the CYP1A2 inhibitor fluvoxamine and          the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide plus the CYP3A4/P-gp          inhibitor ketoconazole in healthy male subjects.      Part 2      1) To evaluate the pharmacokinetics of pomalidomide administered with the CYP3A4 inducer     carbamazepine compared with pomalidomide alone in healthy male volunteers.      Secondary Objectives      1) To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with     ketoconazole, fluvoxamine and/or carbamazepine.      In addition: To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered     with ketoconazole, fluvoxamine and/or carbamazepine.   "
120597|NCT01707381|"     This clinical investigation is being performed to compare the effect of BOL-303259-X dosed     once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular     pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or     ocular hypertension (OHT).   "
120598|NCT01707368|"     The purpose of this observational study is to document the course of disease and relapse     management during treatment with Daivobet® Gel under consideration of patient`s individual     application habits under daily use conditions.   "
120599|NCT01707355|"     The poster is effective in improving the level of knowledge regarding dental trauma of     primary and secondary schools teachers in Hong Kong.      A cluster randomized controlled trial was conducted in mid May 2011,to test the level of     knowledge regarding dental trauma with two groups, the intervention group with posters and     control group without posters. A questionnaire is used to test the level of knowledge.   "
120600|NCT01707342|"     The purpose of this study is to evaluate the absolute bioavailability and pharmacokinetics     (what the body does to the medication) of simeprevir (TMC435) after administration of single     oral doses of 50 mg and 150 mg when administered together with a single intravenous (IV) dose     of 100 microgram [3H]-TMC435 in healthy male participants.   "
120601|NCT01707329|"     This phase II randomised, double blind, placebo controlled, multicentre trial is designed to     assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy     alone in patients who have progressed after benefiting from previous second or third-line     icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung     cancer.   "
120602|NCT01707316|"     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the     medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754     (canagliflozin) and its main metabolites (break-down products) following 2 different doses of     canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will     also be assessed.   "
120603|NCT01707303|"     This is a randomized, controlled, pilot study of two separate Cohorts of patients from the     intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical     therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50     patients and randomize to receive either two physical therapy sessions per day or usual care.     Outcome will be length of hospital stay measured in days. Secondary outcomes will be     mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength     assessments and the short physical performance battery (SPPB). Study subjects will have blood     for cytokine analysis through their first week of study.   "
120604|NCT01707290|"     The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in     participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and     113 (NCT01685801).   "
120669|NCT01706445|"     To study the effects of an 8-week combined inspiratory muscle training and exercise     (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal     inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak)     (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in     children with Cystic Fibrosis (CF) (secondary outcomes).   "
120962|NCT01702623|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Oxcarbazepine Suspension 600 mg under fasted conditions.   "
120605|NCT01707277|"     Previous studies have evaluated the effects of inspiratory muscle training in patiens with     heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic     role of inspiratory muscle training in patients with heart failure and preserved ejection     fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training     improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as     left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living     With Heart Failure Questionnaire) in patients with heart failure with preserved ejection     fraction and non-reduced inspiratory muscle strength.   "
120606|NCT01707264|"     Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30     subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and     pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.   "
120607|NCT01707251|"     Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours     morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary     objective is to determine if it decreases respiratory depression measured using RD, improves     area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain     threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of     nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI     or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen     and control groups.   "
120608|NCT01707238|"     The purpose of this study is to compare the subjective performance for handling of two daily     disposable contact lenses, stenfilcon A and etafilcon A.   "
120628|NCT01706978|"     This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff     repair; soft tissue and bone trephination. Trephination is a procedure that involves making     small perforations either in the torn tendon near its edge, or in the bone that the tendon is     repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the     shoulder. Trephination is a new technique that is used in addition to the standard method of     repairing the rotator cuff tendon.      This study will help to determine whether this technique improves the speed of healing, the     strength and the re-tear rate of the repair. You are being asked to take part in this study     because you have a tear of the rotator cuff that requires surgical treatment. A total of 90     participants will participate in this study.   "
120609|NCT01707225|"     The investigators hypothesize that octreotide LAR (Long Acting Release) safely decreases GI     bleeding in patients with a left ventricular assist device (LVAD). Patients undergoing     implantation of non-pulsatile, continuous-flow LVAD have a higher incidence of     gastrointestinal bleeding. This is a significantly associated morbidity and can threaten a     patient's life as well as their ability to undergo eventual heart transplantation secondary     to both general health/strength and the potential development of antibodies to blood products     that would make future transfusions and transplantations more difficult.      If this research finds that use of octreotide LAR can decrease the incidence of     gastrointestinal bleeding in this patient population, it will revolutionize the manner in     which these patients are managed. The finding of reduced GI bleeding would allow the patient     to have less exposure to blood products, reduce hospitalizations, and ensure that subsequent     transplant planning not be delayed. This would not only be of great benefit to the patient,     but would significantly decrease health-care costs through preventive measures.      The goal of this project is to study whether the regular administration of monthly octreotide     LAR is safe and if it will decrease the incidence of gastrointestinal bleeding in patients     undergoing implantation of non-pulsatile, continuous flow left ventricular assist devices     (LVAD).   "
120610|NCT01707212|"     There are numerous pain management strategies available for the management of infant     immunization pain. The majority of infants, however do not benefit from these interventions,     which causes them to suffer pain unnecessarily. This study will assess the impact of     educating parents about pain management strategies on their knowledge and behaviour regarding     pain management during routine 2-month infant immunization injections.   "
120611|NCT01707199|"     In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium     falciparum resistance to chloroquine. In 2003 the high failure rate of chloroquine against     falciparum malaria led the national malaria treatment programme to switch its recommended     first line drug treatment for uncomplicated Plasmodium falciparum malaria to     artemisinin-based combination therapy (ACT) in the form of     Artesunate/Sulphadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7     days).      For operational reasons, prior to recent studies (manuscript in preparation) there have been     no molecular data on P. falciparum SP resistance markers from within the borders of     Afghanistan. These studies have revealed early evidence of increasing SP resistance     (resistance polymorphisms with double DHFR & triple DHPS mutations). The aim of this study is     to conduct a focused, prospective study in Kunar for monitoring of the efficacy of the AS+SP     combination in this province, along with molecular studies of isolates from recruited     patients.   "
120612|NCT01707186|"     PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the     mid-1990s; the task was first developed as a simple measure of how a person was coping with     his or her experience of illness. This is an international, multicentre study to evaluate the     PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the     illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges,     Montreal and Queensland. The study will recruit 200 patients in total.      In addition to the procedures for the patient's routine clinical visit, the patients will be     invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be     asked to attend 3 times over 24 weeks   "
120613|NCT01707173|"     This is a research study of African American parents/caregivers of newborns. The purpose of     this research study is to learn what type of educational materials about infant safety and     safe infant sleep are most effective and acceptable to parents and caregivers. The     investigators will compare the responses of parents who receive enhanced materials to the     responses of parents who receive the ordinary materials that are currently in use.   "
120614|NCT01707160|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin     30/70 PreMix in healthy volunteers.   "
120617|NCT01707121|"     Over the last decades different life style factors have been established as risk factors for     various diseases. The obesity pandemic displays a good example of a disease where great     effort is undertaken to characterize risk factors associated with obesity (1). Smoking is     another life style risk factor established since several decades, and where primary     prevention has been increasingly successful (2, 3). Cardiovascular epidemiologic research at     the University of Gothenburg recognized PA as a factor of importance early on and thus     included PA related questions in the work up of studies with large cohorts (4-6). A 4-level     scale was introduced in the late 1960:s by Saltin and Grimby (7) and has been used     extensively since then. With this background it is of interest to record physical activity     one year and one month prior to certain types of elective surgery and to study the     relationship of PA to surgical complications and recovery is of interest.      The aim of this study is to investigate whether a higher physical activity prior to a     surgical procedure reduces hospital stay, sick leave and the complication rate.      A secondary aim is to investigate the effect of preoperative physical activity on the rate of     resumption of QoL and normal physical function.   "
120618|NCT01707108|"     The aim of the present study is to evaluate the 1-year and 3-year survival and success of     MIS® C1 implants with a length of 10-15mm.      Specific Aims        1. To study 1-year and 3-year implant survival rate C1 implants        2. To study 1-year and 3-year implant bone level changes of C1 implants   "
120629|NCT01706965|"     Rater blinded trial of six weeks of Kuvan vs. multivitamin in 60 outpatients with     schizophrenia or schizoaffective disorder. The aims are to evaluate an anticipated clinical     response to Kuvan treatment including negative symptom and cognitive deficits, evaluate     safety of Kuvan treatment for schizophrenic patients and evaluate the relationship of changes     in plasma Kuvan levels and efficacy outcomes.   "
120630|NCT01706952|"     The purpose of our study is to assess the effect of topical vasoconstriction (cocaine 4%     versus adrenaline 1/1000) on the surgical field during endoscopic sinus surgery.   "
120619|NCT01707095|"     Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive     coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent     to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to     the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653]     In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar     site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic     cholecystectomy. Our benchtop research compared bundling of the camera cord with the active     electrode cord versus unbundling of the camera cord with the active electrode cord and found     a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL, Robinson,     TN, et al. Surg Endosc (2012) Epub.]      This study plans to compare thermal injury which occurs during two commonly used operating     room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords.     And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The     primary outcome is the incidence of thermal injury at the skin adjacent to the camera port     site (the umbilical port) that will be diagnosed by histology.   "
120620|NCT01707082|"     Part A of the study will test the safety, the amount of drug in the body, and effects of the     drug in the body after multiple doses. This will be conducted in healthy overweight adults.     Part B of the study will test the effects of multiple doses of the investigational drug on     the amount of midazolam, an approved drug, in healthy adults.   "
120621|NCT01707069|"     This is a research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is     called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is     tolerated and how research participants respond to the vaccine in various doses.     CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not approved for use by     the United States Food and Drug Administration (FDA) but is available in research studies     like this one. This is the first time that CryJ2-DNA-LAMP Plasmid vaccine is being given to     humans.      The purpose of this study is to evaluate the safety of an investigational vaccine intended to     treat allergy to Japanese red cedar. The vaccine is composed of DNA, which is the material     that cells use to provide instructions to make proteins. The DNA carries the information     necessary to make a special protein which is a combination of a protein found in all cells,     LAMP (lysosomal associated membrane protein), and the protein from Japanese red cedar that     causes the allergy known as Cry J2. This vaccine is intended to help re-educate the immune     system with respect to how it will respond to naturally occurring red cedar allergen and     eliminate the allergic symptoms. Another purpose of this study will be to document the immune     response to the vaccine      Subjects that are eligible to participate in this study will be assigned by whether they are     sensitive or non sensitive to CryJ2 or Mountain Cedar and chance (like flipping a coin) to     one of 3 study vaccine groups:      Group 1: will receive four (4) 4-milligram doses of the study vaccine. Group 2: will receive     four (4) 2-milligram doses of the study vaccine. Group 3: will receive four (4) 4-milligram     doses of the study vaccine.      The study vaccine is administered as an intramuscular injection. Enrolled subjects will     receive the study vaccine every 14 days (at day 0, 14, 28 and 42). Subjects will know their     study vaccine assignment. Participants who are not allergic to Japanese red cedar will be     assigned to Group 1. Participants who do have an allergy to Japanese red cedar or Mountain     Cedar will have an equal chance of being assigned to Group 2 or 3.      There will be between 18 to 30 men and women participating in the study at one location. Your     participation in this study will last approximately 72 days.   "
120622|NCT01707056|"     The purpose of this study is to evaluate whether taking thyroid hormone medication with     beverages other than water, decreases absorption of the medication by the intestine.     Specifically we are interested in whether coffee, coffee with milk, or black tea affects how     thyroid medication is absorbed by the body. Previous studies have suggested that taking     thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given     that many patients take their thyroid medicine with beverages other than water, and     specifically with coffee or tea, understanding whether and how much coffee or tea may     decrease thyroid hormone absorption is important for clinical practice.      This study will help determine the safest and most effective way for adults to take their     thyroid medication and will guide medical practitioners in how to counsel their patients when     they prescribe thyroid hormone.   "
120623|NCT01707043|"     This is an open label, investigator-blinded, cross over, prospective, single center study of     subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone     dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone     dipropionate 0.064%) Topical Suspension will each be applied topically once daily.      The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005%     and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene     0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque     psoriasis.   "
120624|NCT01707030|"     Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous     for them than it is for a non-infected person. In this VA study, such individuals will be     screened and given feedback on their drinking using an Internet-based program which has been     shown to reduce drinking in other populations. The research team will evaluate whether the     program helps Veterans drink less over time and thereby improve their health.   "
120626|NCT01707004|"     This phase II trial studies how well decitabine and total-body irradiation followed by donor     bone marrow transplant and cyclophosphamide works in treating patients with relapsed or     refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a     donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells     from a donor are infused into the patient they may help the patient's bone marrow make stem     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells     from a donor can make an immune response against the body's normal cells. Giving decitabine     and total-body irradiation before the transplant together with high-dose cyclophosphamide,     tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.   "
120627|NCT01706991|"     The purpose of this project is to compare the performance of the Pediatric Vision Scanner     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at     detecting amblyopia and strabismus. All tests and observations will be done at a single visit     over the course of approximately 30 minutes.   "
120631|NCT01706939|"     This trial aims to directly compare a reduced radiation dose to the standard of care in     HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two     groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are     non-inferior to standard dose CRT.   "
120632|NCT01706926|"     The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of     mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with     moderate-to-severe adult onset Rheumatoid Arthritis (RA).   "
120633|NCT01706913|"     This is a randomized, controlled study to compare patients evaluated and managed by internal     medicine hospitalists alone versus patients who are additionally evaluated by a dermatologist     when they are admitted to the hospital, aiming to demonstrate that hospital admissions for     cellulitis that involve early dermatology consultation will reduce hospital length of stay,     readmission rates, prevalence of pseudocellulitis, cost, and antibiotic usage. The hypothesis     of this study is that obtaining inpatient dermatology consultations, within 24 hours of a     patient being admitted to the hospital for cellulitis, will reduce the length of stay,     readmission rate, cost, and antibiotic usage of the patient‟s admission as well as properly     evaluate and diagnose patients with pseudocellulitis. The primary objective will be to     measure the difference in the length of stay for patients who are randomized to a dermatology     consultation within 24 hours of hospital admission (active arm) versus being managed by an     internal medicine hospitalist alone, as is the standard of care (control arm). The length of     stay for each arm will be assessed once the study has been completed. The secondary endpoint     will be to measure readmission rates for cellulitis after patients are discharged from the     hospital. An additional endpoint will be to determine if antibiotic usage differs between     patients randomized to a dermatology consultation and those not. Exploratory analyses will     assess the percentage of patients with a concomitant known predisposing factor for recurrent     cellulitis such as lymphedema, leg ulceration, tinea pedis, or onychomycosis, as well as the     association of fever >100.5 F and a history of a prior episode of cellulitis.   "
120634|NCT01706900|"     Incubator temperature is one of the most precious variables in IVF labs. When the IVF     started, almost all incubator temperatures were set at 37 degrees which mimic in vivo     conditions. Some authors speculated that gametes and early embryos might need low     temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37     degree or slightly lower 36.5 degree and extensively investigate to find which is better to     crucially introduce a solid evidence through this RCT.   "
120635|NCT01706887|"     Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt     retention by the kidney. The study address the consequence of a frequent genetic variation     leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to     excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute     a genetic predisposition to (or protection against) salt-sensitive hypertension.   "
120636|NCT01706874|"     The purpose of this study is to assess the impact of an intervention (scaled every 06 months     associated with the use of mouthwash with essential oils (toothpaste and Listerine® 2 times /     day containing polymer Triclosan (Colgate Total®)) on the activity of rheumatoid arthritis   "
120637|NCT01706861|"     The objective of the study is to actively gather additional information on safety, device     performance and possible emergent risks following the use of Celotres in a post-market     setting when used to reduce the recurrence rate, volume, appearance and/or symptoms     associated with keloid scarring in subjects undergoing surgical excision of keloids as     compared to the scientific literature.   "
120638|NCT01706848|"     The objective of the study is to actively gather additional information on safety, device     performance and possible emergent risks following the use of Celotres in a post-market     setting when used to improve wound healing and the resulting scar consequences following     suturing of a wound.   "
120639|NCT01706835|"     This is a phase 1 open-label study to investigate the pharmacokinetics of aldoxorubicin     administered as a 30 minute infustion every 3 weeks for up to 8 cycles in subjects with     advanced solid tumors.   "
120640|NCT01706822|"     To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or     anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary     endpoints.   "
120641|NCT01706809|"     The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF     and others ability to predict time to recidive and progressions free survival.   "
120642|NCT01706796|"     The primary purpose of this study is to estimate the relative bioavailability and food effect     of PF-06273340 tablets.   "
120643|NCT01706783|"     This trial is conducted in Europe. The aim of the trial is to investigate the safety,     tolerability, availability and distribution in the body of once-weekly long-acting growth     hormone (NNC0195-0092) compared to once daily Norditropin NordiFlex® in adults with growth     hormone deficiency (GHD).   "
120644|NCT01706770|"     The primary objective of thes study is to confirm that the ocular response to the Test lenses     are similar to those of the Control lenses when used in a 1 week planned replacement, daily     wear modality over a 1-month period.   "
120645|NCT01706757|"     The ability to walk is one of the fundamental attributes of human beings. However, with     advancing age this ability is modified by a combination of physiological and pathological     aging.These changes mainly involve an irregularity of the pitch, reducing the length of the     stride, instability and a decrease in walking speed (Beauchet et al., 2002). Tinetti,     Speecheley, Ginter (1988, from Ch Wider, F. Vingerhoets, J Bogousslavsky, 2005) show that     20-30% of heathly older fall each year and state that one of these falls, 25% result in     injuries with significant effect and 5% a fracture. In addition to the risk of fracture fear     of falling exists in many older people even before a drop in effective (Recommandation of     HAS, 2005).In France, about 9 000 deaths of people aged over 65 are associated each year with     a fall and this association increases rapidly with advancing age in both sexes. It is     therefore important in terms of public health, learn to recognize the gait disturbance, to     prevent and to make adequate assessments to reduce the risk of falls. Tools exist to assess     the risk of falling. Some are comprehensive but time-consuming and are generally discarded in     favour of other simpler tests (test of Tinetti or get up and go test). However, the listing     of these lacks precision, particularly in terms of duration single timer.To overcome these     biases, innovative technology solutions seem to be a good way. In this study, the     investigators will use the motorized go-cart developed by INRIA, entitled ANG (for Assisted     Navigation Guide), to obtain more reliable and accurate measurements of parameters such as     walking speed and direction. Thus, the investigators set the main objective, to compare a     standard evaluation of the process to a technology assessment, in participants aged 65 to 86     years. And as secondary objectives : evaluate the acceptance of using go-cart ANG in the     elderly, develop an index of walking and test the feasibility of detecting a weakness of the     knee joint by ANG undetected at clinic.   "
120694|NCT01706120|"     The addition of bevacizumab to first-line chemotherapy has been shown to improve progression     free survival for patients with ovarian cancer. The purpose of this study is to explore the     potential role of clinical and biologic factors in identifying those patients who benefit     most from this combined therapy in terms of progression free and overall survival.   "
120646|NCT01706744|"     The main goal is to investigate the following topics:        1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge          to Verdal Municipality, be equally effective in preventing aggravation of disease and          loss of function for patients over 60 years that have been hospitalized in Levanger          hospital?        2. Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital          is not located in the same Municipality, comparable to the cost by direct discharge to          the Municipality of Verdal, for patients over 60 years that have been hospitalized in          Levanger hospital?        3. Which issues are considered important by patients and health personnel during discharge,          arrival and follow up in the Municipality, to ensure an optimal interaction between the          involved units.   "
120647|NCT01706731|"     This research is to study the effectiveness of cognitive behavioral therapy-CBT and     Psychotherapy by trained buddhist monks. There are generally accepted that both cognitive and     Buddhist concepts are related. This randomized controlled trial is to study the elderly     participants who suffer major depressive disorder according to DSM-IV. The subjects will be     divided into two groups. The experimental group will receive 12 sessions of CBT 2 times per     week for 6 weeks in addition to usual treatment. The control group will receive treatment as     usual and general conversation (non-CBT) with monks. Pretreatment factors (such as attachment     style, interpersonal factors) of both therapist monks and patient participants will be     studied.   "
120648|NCT01706718|"     Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and     could therefore be an important dietary component in the management of hypertension and     cardiovascular disease, however consumption is relatively low. We evaluated the effects of     beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and     blood pressure response in healthy men.   "
120649|NCT01706705|"     The goal of this clinical research study is to learn if computed tomography (CT) and magnetic     resonance imaging (MRI) images can better help to plan internal radiation treatment.   "
120650|NCT01706692|"     The purpose of this study is to evaluate the long-term course of patients with psoriasis and     psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric     acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A     patient will be included at first initiation of the treatment and will remain in the registry     for 5 years, regardless of subsequent therapy.      The registry will also evaluate safety clinical outcomes and health related quality of life.   "
120651|NCT01706679|"     To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment     on Fridericia's corrected QT interval (QTcF).   "
120652|NCT01706666|"     This randomized phase II trial studies how well giving bortezomib with or without combination     chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma     who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet     known whether giving bortezomib is more effective with or without combination chemotherapy in     the post transplant setting.   "
120653|NCT01706653|"     The purpose of this study is to determine whether consumption of the active product affects     postprandial changes in metabolic indices, in comparison to the control product.   "
120654|NCT01706640|"     This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage,     Outcome & Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re-     Operative procedures.      Objective of this study is to assess current practice pattern and best practice sharing of     usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous     reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence,     severity and extent of post surgical adhesion enforcement of suture lines in lung resection     procedures (3) From this data to document and generate a real life experience on the use of     Coseal in cardio vascular and thoracic surgery.      Number of expected patient enrollment is 750 from 20 participating sites.   "
120670|NCT01706432|"     This pilot clinical trial studies hypofractionated image guided radiation therapy in treating     patients with stage IV breast cancer. Radiation therapy uses high energy x rays to kill tumor     cells. Giving radiation therapy in different ways may kill more tumor cells   "
120975|NCT01702454|"     The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals'     investigational vaccine GSK2321138A in children who previously participated in study 115345     (FLU D-QIV-004 PRI) (NCT01439360).   "
120655|NCT01706627|"     Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for     reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo     controlled trials have been conducted. This study evaluates the effect of melatonin in     improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer     patients. This is a multi-center, randomized, double-blind, placebo controlled trial     conducted in patients with histologically proven advanced non small cell lung, breast, head     and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment     scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or     matched placebo. The patients are required to take the studied drugs at night (after 21.00     pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is     chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT),     adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.   "
120656|NCT01706614|"     Investigation of biochemical and genetic markers in liver disease that might have an     influence on the course of the disease   "
120657|NCT01706601|"     Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population.     This means that many patients are referred to surgical specialist reception with diagnosis     hemorrhoidal disease. The aim of this study is to describe population of patients with     hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what     treatment they are given at a general practitioner as well as in colorectal unit.   "
120658|NCT01706588|"     This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in     approximately 75 patients undergoing surgical removal of an impacted lower third molar.   "
120714|NCT01705860|"     The present study will evaluate the long term effects on scar formation for dermatome-induced     skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment)     alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to     evaluate both time to complete wound closure and quality of the resulting scar when     Collagenase Santyl® Ointment was used to treat the wound.   "
120659|NCT01706575|"     This open-label, single-arm, multicenter study will evaluate the efficacy and safety of     adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in     participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA     suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg     decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg     subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will     be a further 48 weeks, during which the participants will continue their NA treatment.   "
120660|NCT01706562|"     The purpose of this study is to investigate the overall success rate of itraconazole     intravenous treatment for a period of more than 7 days.   "
120661|NCT01706549|"     Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical     examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The     aims of the study are:        1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons          for the pain.        2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.        3. to reveal the impact of pain on quality of life.   "
120662|NCT01706536|"     This is a randomized, double-blind, placebo-controlled, parallel arm study. The study     population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to     severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.   "
120663|NCT01706523|"     This is an open-label extension protocol that will provide necessary data on the safety,     tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.   "
120664|NCT01706510|"     Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients     with stable coronary artery disease.   "
120665|NCT01706497|"     The postoperative period after congenital heart surgery in children can be a very critical     episode, where it is of utmost importance to closely monitor the circulation in these     patients. Invasive hemodynamic monitoring tools available in the adult population, are often     not suitable to use in small children.      The Fore-Sight(TM) is a non-invasive monitor for brain tissue oxygenation (SctO2), by     projecting harmless near-infrared light trough the skin, skull, and brain via a disposable     sensor that is applied on the forehead of patients. In many centres, the Fore-Sight (TM) is     part of the routine monitoring of children during cardio-pulmonary bypass for congenital     heart surgery. Although the monitor has not been tested for this purpose, it is often     continued in the postoperative phase in the intensive care unit (ICU), where it is used to     monitor the hemodynamic situation of the patient.      The purpose of the present study is to examine and validate the use of the Fore-Sight monitor     for hemodynamic monitoring of children in the postoperative phase after cardiac surgery.      The study hypothesis is whether SctO2 desaturations are predictive for future hemodynamic     deterioration of the patient, and whether these SctO2 desaturations are predictive for the     outcome of these patients.   "
120666|NCT01706484|"     The purpose of this trial is to determine whether 2 different dosages of a herbal extract     (240 and 480 mg/day) are more effective than placebo in the treatment of patients with     chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5     and Visit 6.   "
120667|NCT01706471|"     Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival     in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection     episodes of cadaveric allograft recipients. Although marked progression has been made in     initial survival rates, long-term kidney graft survival has yet to show such encouraging     results. Because CNIs are associated with adverse effects, particularly nephrotoxicity, which     contribute to declining organ function and eventual graft loss. In kidney transplants,     progressive allograft dysfunction has been shown to develop in as many as 94% of patients by     1 year.      Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be     balanced against the maintenance of adequate immunosuppression.      Certican allows CNI dose reduction then provides renal function improvement and current PSI     strategy point out that early intervention is important in managing the risk of CAN before it     develops in both de novo and maintenance renal transplant recipients.      To demonstrate Certican early introduction after 1 month provides better renal function with     no change of efficacy compared to standard regimen, and also prevent delayed wound healing.   "
120679|NCT01706315|"     This will be a randomized, placebo-controlled, single blind study to investigate the safety,     tolerability and pharmacokinetic (PK) profile of GSK2140944 following repeat oral doses in     healthy adult subjects. The study will include a Screening period (40 days), Treatment period     (16 days) and a Follow-up period (26 to 30 days). A single dose will be administered on Day 1     for characterization of single dose PK, followed by twice-daily (BID) or thrice-daily (TID)     dosing on Days 3 to 16. Subjects may only be randomized to one cohort per the randomization     schedule. Up to 6 cohorts will be enrolled using a sequential panel. Subjects in Cohort 1     will receive GSK2140944 (6) and placebo (2). Subsequent cohorts will enroll 16 subjects such     that 12 subjects will receive GSK2140944 and 4 subjects will receive placebo, per dose level     according to the randomization schedule. Dose escalations are planned to run in successive     weeks. Cohort 2 may begin dosing once subjects in Cohort 1 have completed 7 days of BID     dosing, PK data is reviewed and safety data from at least 6 subjects is available. Each     subsequent dose escalation will commence only when GSK2140944 safety data and available PK     data of at least 12 subjects dosed at the previous dose level have been reviewed. The number     of cohorts may be reduced or expanded if needed. The first planned dose is 400 milligram (mg)     BID but may be modified based upon emergent PK, safety and tolerability data from ongoing     clinical study BTZ115198 evaluating single and repeat intravenous (IV) doses of GSK2140944.     The projected dose for Cohort 2 is 800 mg BID, Cohort 3 is 1500 mg BID, Cohort 4 is 2300 mg     BID or 1500 mg TID and Cohort 5 and cohort 6 will be decided later. The planned maximum dose     is 2500 mg TID but may be modified based upon emergent safety, tolerability and PK data.     Doses of GSK2140944 or placebo will be administered following a moderate fat meal.   "
120671|NCT01706419|"     Rice fortification has been shown to be safe and effective in improving micronutrient status     in many studies around the world. However, most studies have been done in Latin America,     Africa and India. There are no studies available from Cambodia. Moreover, there is no data     available on whether fortified rice can reduce the prevalence of anemia in school children in     Cambodia, nor whether there will be additional benefits, such as better learning capability     of school children or fewer days missed due to better health. To inform WFP, Cambodian policy     and the public on the potential benefits of fortified rice on health and development for     Cambodian school children, an intervention study will be conducted in Kampung Speu province     during the 2012 - 2013 school year. The study will be conducted by IRD, PATH and WFP. Sixteen     schools will be selected to receive either the normal rice provided by the WFP school meal     program, or fortified rice instead of normal rice. Three (3) different types of fortified     rice will be tested, to identify the best type of fortified rice. In addition, 4 schools with     no school meal program will be selected to serve as control. School attendance and morbidity     will be followed in all children in the participating schools over the whole school year.     Biochemical indicators of micronutrient status will be determined in a subgroup of children     (25% of the children), which requires collection of blood, urine and stool samples.   "
120672|NCT01706406|"     The purpose of this study is to pilot test and determine the efficacy of a psychoeducational     intervention (PED) we recently piloted in a group format for women with acquired sexual     arousal disorder (FSAD).      HYPOTHESES:        1. - Compared to baseline measures, the PED will result in significant improvement in          self-report measures of: (a) subjective sexual arousal; (b) perception of genital          arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual          distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of          life.        2. - It is unknown what effect the PED will have on actual physiological sexual arousal.        3. - The group format will be a feasible and cost-effective method of delivering          empirically supported treatment to women with sexual arousal difficulties and will          contribute towards meeting the needs for sexual health care for women on the clinic          wait-list at the BC Centre for Sexual Medicine.   "
120673|NCT01706393|"     The purpose of this study is to evaluate the effect of probiotics to improve the intestinal     microbiome in malignancy patients who get pelvic/abdominal radiotherapy.   "
120674|NCT01706380|"     The present study, in an out-patient setting for substance use treatment in adolescents,     examines the effect on treatment retention of a mobile telephone follow-up technique     (interactive voice response), with or without personal feedback. Subjects in treatment for     substance use disorders will be followed by automated mobile telephone contact with questions     about psychiatric symptoms and substance use, and the investigators hypothesize that this     technique, including a personal feedback reporting back to the client whether his or her     status is changing in one way or another, may increase the treatment retention, possibly by     means of an intensified treatment contact.   "
120675|NCT01706367|"     This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three     dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85     years. The main goal of the study is to determine how safe and well-tolerated the vaccine is.     In addition, the study aims to assess the immune response to the C difficile vaccine.   "
120676|NCT01706354|"     End stage renal failure (ESRF)describes an irreversible loss in renal function. The majority     of these patients will opt for haemodialysis (HD)as their chosen method of renal replacement     therapy (RRT). Arteriovenous fistulae (AVF) are the optimal method of achieving vascular     access to permit HD. AVF are created with a small surgical procdure to join the artery and     vein together. Over the next 6- 8weeks after surgery the AVF should grow (mature) into a     vessel suitable for needles to be inserted for dialysis. Unfortunately however, around 24% -     35% of AVF fail at an early stage. Some anaesthetic techniques can influence intraoperative     blood flow and venous diameter, factors which are associated with fistula success. There     remains no conclusive evidence that any particular anaesthetic technique can significantly     influence long term surgical outcome. This study aims to investigate whether a regional,     compared to local, anaesthetic technique can affect fistula patency.   "
120677|NCT01706341|"     The purpose of this study is to investigate the effect of administering a small dose of     glucose on the pregnant women and their neonates during cesarean section. We investigate the     safety and efficacy of use of a glucose-containing solution for the pregnant women and the     neonates.   "
120730|NCT01705652|"     The purpose of the study is to (1) to determine the rate of PSA decline (the number     declining). Tissue will be obtained for ancillary studies and (2) to determine the number of     patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with     standard radiation therapy. The Secondary Objective is to confirm the tolerability of this     regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of     Nexrutine®. Molecular response is defined as changes in the molecular pathways.   "
120731|NCT01705639|"     The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants     of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3     months:        -  OGTT        -  questionnaires about sleep and activity        -  Actigraph        -  Anthropometry        -  Blood pressure   "
120678|NCT01706328|"     This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week     parallel group study evaluating the effects of once daily in the morning treatment of FF/VI     Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on     lung function in COPD subjects.      Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to     evaluate the subject's adherence with study treatment, study procedures and assessment of     disease stability.      At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the     Randomization Criteria will be randomized to double-blind study medication (12-week treatment     period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone     Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in     NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1     inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening     (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study     medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return     to the clinic at the end of the treatment period.      A follow-up phone contact will be performed approximately 7 days after the last clinic visit.     The overall study duration (Screening to Follow-up) for each subject is approximately 15     weeks.   "
120680|NCT01706302|"     The study will assess the burden of RSV-attributable general practice consultations,     hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.   "
120681|NCT01706289|"     Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in     subjects with type 2 diabetes mellitus   "
120682|NCT01706276|"     Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin     concentrations through compared with laboratory measurement during major hepatic surgery, and     to determine the source of discordance between two methods.   "
120683|NCT01706263|"     One of the main success factors in acne therapy is user compliance with treatment, product     cost, availability and ease of use. Poor compliance may translate into decreased efficacy     (either not improving symptoms well enough or not improving symptoms fast enough),     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a     lack of understanding of the instructions for use, or product cost/availability. Whatever the     reason, poor compliance translates to decreased efficacy and increased frustration on the     part of the user.      The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the     counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.   "
120684|NCT01706250|"     One of the main success factors in acne therapy is user compliance with treatment, product     cost, availability and ease of use. Poor compliance may translate into decreased efficacy     (either not improving symptoms well enough or not improving symptoms fast enough),     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a     lack of understanding of the instructions for use, or product cost/availability. Whatever the     reason, poor compliance translates to decreased efficacy and increased frustration on the     part of the user.      The current study will evaluate and compare the efficacy and tolerability of 2     over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne:     MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner     Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and     Revitalizing Toner.   "
120685|NCT01706237|"     Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic     LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed     of visual recovery results indicate that the visual recovery in the first 4 hours after the     LASIK procedure show the most variability. A patient's ability to drive after their LASIK     procedure would potentially alleviate a challenge that patients often face in taking     additional time off work or simply finding a ride to there LASIK procedure.   "
120686|NCT01706224|"     This study aims to determine the sero-prevalence of anti-pertussis antibodies among     healthcare professionals at hospital centres in Spain.   "
120687|NCT01706211|"     At least 30% of patients initially treated with sulphonylureas for NIDOM will have a poor     response, and in the remaining 70% the subsequent failure rate is approximately 4% to 5% per     year. BRL 49653C has a different mechanism of action to the sulphonylureas, and therefore the     effects on fasting plasma glucose and Hb A1c are expected to be additive. Since circulatory     insulin levels should decrease, and plasma glucose should be regulated, these combinations     are also anticipated to slow both the progression of diabetic complications and delay the     need for exogenous insulin.      The proposed study is intended primarily to determine the effectiveness of BRL 49653C by     measure of glucose homeostasis as determined by Hb A1c and fasting plasma glucose, when added     to sulphonylurea therapy (sulphonylureas are limited to: glibenclamide, glipazide and     gliclazide). In addition, the clinical safety of BRL 49653C will be assessed in this patient     population. The starting doses have been selected based on dose response studies examining     safety, tolerability and efficacy in the U.S.A.   "
120688|NCT01706198|"     This study is designed to compare the effectiveness and safety of Fluticasone     Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg     Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol     ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with     the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma.     This is a Phase III multi-centre, randomised open label study. Subjects who meet the     eligibility criteria are randomised and will enter a 12 month treatment period.   "
120689|NCT01706185|"     This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1,     WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated     bladder cancer.   "
120690|NCT01706172|"     Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be     quite long lasting and debilitating. Dextrose injection with a small needle has been notably     helpful in preliminary studies in reducing pain and improving jaw function. This randomized     trial will compare dextrose injection with sterile water injection for temporomandibular(jaw)     dysfunction, also known as TMD.   "
120691|NCT01706159|"     This trial is conducted in Europe. The aim of the trial is to investigate the effect of     recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active     ulcerative colitis (UC).   "
120692|NCT01706146|"     Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects     an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure,     and premature death. For those with AF and other stroke risk factors, chronic anticoagulation     is recommended to prevent intracardiac thrombus formation and stroke even if the AF is     infrequent or short-lived. This standard of care is based partly on our inability to rapidly     recognize and respond to AF recurrences which can often be brief and asymptomatic, but     exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged     periods of sinus rhythm where the risk of stroke is presumably low.      Recent advances in device technology and drug therapy, however, have the potential to change     the way the investigators manage AF. The use of a small leadless subcutaneous implantable     cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.)     provides the ability to remotely and continuously evaluate a patient for AF recurrences, even     episodes that are brief and asymptomatic. In addition, release of unique oral thrombin     inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto])     allows for rapid onset anticoagulation within minutes to hours of a single oral dose.     Together, these advances allow for continuous AF monitoring with targeted anticoagulation     only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage     while still protecting against stroke.      The aim of this pilot study is to assess the feasibility of intermittent anticoagulation with     a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable cardiac     monitor (Reveal XT) with remote data transmission capabilities.   "
120693|NCT01706133|"     -Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative     impacts on the health of elderly over 70 years ?   "
134696|NCT01521767|"     A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two     Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial     Extended Release Capsules   "
120695|NCT01706107|"     The primary objective of the study is to evaluate the impact of early treatment with Tysabri     in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL)     as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary     objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS     participants over 2 years on the following: annualized relapse rate (ARR), Expanded     Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol     5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual     analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2     years.   "
120696|NCT01706094|"     A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute     ischemic stroke could be to place the patient in a 'lying flat' rather than upright head     position. Given uncertainty over the balance of potential modest benefits and risks, and     variability regarding the ideal head position policy for patients with acute ischemic stroke     around the world, reliable randomized evidence is required to standardize clinical practice.      The main objectives of this pilot phase clinical trial are to determine the feasibility,     safety and potential efficacy of a large-scale cluster randomized clinical trial to assess     whether a simple nursing care policy - 'lying flat head position' - provides beneficial     effects as compared to the standard upright head position in patients with acute ischemic     stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean     cerebral blood flow velocity in the flat down compared to the upright head position, as     assessed by transcranial Doppler to the medial cerebral arteries of patients with anterior     circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down     head position improves neurological status at 7 days and disability at 90 days.   "
120697|NCT01706081|"     This study is being done because women have arm swelling for more than 6 months despite     wrapping and other treatments. This swelling is called lymphedema. It is the back up of lymph     system fluid that causes swelling in the arm. The swelling can just happen, but more commonly     it is caused when lymph nodes are removed during cancer surgery. It can develop right after     breast cancer treatment or weeks, months or even years later. In our preliminary research,     the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction     in lymphedema following acupuncture treatment and there were no serious adverse events during     the treatment or 6 month followup.      This study will include a larger group of patients. Patients will be assigned to one of two     groups, and results of the groups will be compared to see if acupuncture can reduce     lymphedema and whether the effect lasts after acupuncture treatment is completed.   "
120698|NCT01706068|"     Background:      The importance of ischemic ECG changes including St segment elevation, ST segment depression     or T wave inversion that indicate myocardial ischemia are well established and require     appropriate investigation and treatment.      However, there is an abundance of clinical situation, with apparently ischemic ECG change not     indicate traditionally coronary artery related ischemia and therefore require prompt     recognition and treatment of underlying condition, that may be serious and life-threatened.     For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte     abnormalities, intracranial hemorrhage and hypothermia.      Together with them, an ECG ST segment changes may appeared in abdominal serious illness such     as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various vasoactive     and toxic for myocardium substances released, the cause of ST segment changes in     cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma     rennin activity resulted by distension of the gallbladder.      The certain proportion of the patients with ECG changes actually didn't have coronary artery     disease(9,15) or other acute cardiac condition and therefore require treatment of the     underlie illness only without spend the time for cardiac investigation or special     treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with     abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or     unnecessary cardiac catheterization.      In the medical literature the investigators found some case reports and works about the ECG     changes in acute biliary disease in patient with knowing cardiac disease and without it, but     actually incidence of ECG changes that suggest but not represent an acute coronary illness     isn't knowing.      Therefore this is necessary to investigate actually incidence of ECG changes that mimic acute     coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical     and laboratory characteristics that helps to differentiate this patients.   "
120699|NCT01706055|"     This will be prospective, multicentre, observational study. Patients who will initiate     treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0)     i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient     demographics, medical history data, safety parameters, presence of flu-like symptoms and     measures to prevent or treat these symptoms will be collected.   "
120700|NCT01706042|"     Dietary prevention strategies are increasingly recognized as essential to combat the current     epidemic of obesity and related metabolic disorders. The purpose of the present study was to     evaluate the potential effects of legumes in relation to cardiometabolic risk markers and     appetite regulating hormones.   "
120701|NCT01706029|"     Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the     priority domain of improvement for the patients instead a good control of the inflammatory     disease by treatments, even biotherapeutics .      Some studies show that less than 50 % of the patients is satisfied by the care of the pain,     whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a     complex and multifactorial subjective phenomenon requiring a multidimensional evaluation,     while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain     in a single dimension that is the pain intensity.      So, the investigators do not arrange explanation for this observed dichotomy between the     improvement of the clinical and biological inflammatory criteria of the RA and on the other     hand the persistence of pain.      On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the     physiopathology of RA and probably in the pain processing according to recent data of the     literature.      The aim of this study is:        -  to assess the multidimensional origin of the pain in RA patients by means of          questionnaires        -  to look for a possible correlation between the serum level of cytokines and pain.   "
120702|NCT01706016|"     Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating     with histological analysis of the specimen the percentage of tumor cells remaining in the     area treated by the laser   "
120703|NCT01706003|"     Patients will be randomly assigned to receive their follow-up care via telemedicine or     in-office visits.   "
120704|NCT01705990|"     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of     Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in     prime-boost regimens in HIV-uninfected, healthy adult volunteers.   "
134765|NCT01520870|"     This multicenter, 2-stage, open-label, phase II trial aims to assess the efficacy and safety     of dacomitinib in adult patients with recurrent Glioblastoma (GBM) with EGFR gene     amplification and/or EGFRvIII mutation.   "
120705|NCT01705977|"     The purpose of this study is to further enhance the existing knowledge regarding the side     effects of belimumab when given with other lupus medicines to adults with active systemic     lupus erythematosus (SLE). This study mainly focuses on collecting information on serious     events that are not that common or may only be seen with long-term treatment. These events     include death, serious infections and other infections of interest, cancers, serious mental     health problems, including depression and suicide, and serious infusion and hypersensitivity     reactions. This study is being done to help understand if treatment with belimumab increases     the risk for these types of events. This study will also see if patients receiving belimumab     with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.   "
120706|NCT01705964|"     Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled     bronchodilators (β2 agonists) for children with severe asthma exacerbation.      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists)     for children with severe asthma exacerbation.      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose     of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects     20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by     an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23     gauge one inch needle.      In addition to the study intervention, the standardized treatment pathway based on the     current asthma guidelines in use at the investigator's center will be utilized. This pathway     includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration     and dosages of these other interventions will be administered at the discretion of the     treating provider.   "
120707|NCT01705951|"     This project is prompted by the urgent public health need to identify novel strategies to     prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data     that suggests cessation of smoking results in rapid amelioration of endothelial function. The     higher prevalence of CVD and metabolic syndrome in smokers have become major health care     concerns. Therefore, finding optimal intervention strategies to combat these growing     epidemics is imperative. We are investigating the efficacy of resistance training to     ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in     four groups: presence or absence of resistance training with or without cessation treatment +     nicotine replacement.      The investigators hypothesize that resistance training will improve cardiovascular function     in smokers; however, the responses will be better in those who also stop smoking. In     addition, resistance training will decrease smoking, however, the effects of counseling and     nicotine replacement alone or counseling and nicotine replacement in conjunction with     resistance training will be better than resistance training alone.   "
120708|NCT01705938|"     This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential,     escalating, single-dose, study designed to evaluate the safety, tolerability,     pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333     tablets.   "
120709|NCT01705925|"     The purpose of the study is to provide comprehensive follow-up in patients with Long QT     Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and     effective management and treatment options.   "
120710|NCT01705912|"     The purpose of this study is to assess effects of a home exercise program, supervised by     assistant nurses with the aim of preventing falls.      Community living persons 65 years of age or older having a risk of falling were invited to     participate. Participants were randomized to either training or control.      The training program was individually designed by a physiotherapist and the 5-month program     performance was supervised in the partcipants home by eight home visits from an assistant     nurse.      All participants received a visit from an occupational therapist who assessed the home and,     if necessary, gave advice.   "
120732|NCT01705626|"     The purpose of this study is to determine the prevalence of patients with a polyneuropathy of     undetermined etiology based on the normal results of laboratory data (CRP, glucose,     electrolytes, urea,transaminases, TSH, immunoglobulins, vitamin B12, RF, ANA, antibodies     against Lyme borrelia) no anamnesis for carcinoma, no continuous alcohol consumption; no     light-chain-amyloidosis; no anamnesis for heavy metal exposure.   "
124491|NCT01656226|"     The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona     AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis     patients after 6 months of treatment.   "
120711|NCT01705899|"     Islet transplantation can provide physiologic insulin replacement to patients with type 1     diabetes without the complications associated with whole pancreas transplantation. The     purpose of this study is to achieve insulin-independence in patients with type 1 diabetes,     thereby eliminating the need for exogenous insulin injections to maintain normal glucose     levels, ameliorating severe hypoglycemia and potentially decreasing the development of     diabetes-related complications. This study will investigate islet transplantation in subjects     who have preserved renal function and subjects who have undergone cadaveric renal     transplantation, since the latter subjects are already on immunosuppression.      This is a single center, prospective trial of islet transplantation in subjects receiving     islets alone or islets after kidney transplant. This is a phase I study investigating the use     of islet transplantation for the treatment of type 1 diabetes. Subjects will be eligible for     an islet transplant if they meet all of the inclusion criteria and none of the exclusion     criteria outlined in the protocol. In brief, the aims of this study are to establish an islet     transplant program at the Ohio State University, determine the safety of islet     transplantation in islet alone and kidney transplant recipients, determine whether islet     transplantation will reduce the frequency of severe hypoglycemic events, determine whether a     novel steroid-free immunosuppressive protocol will prevent rejection in islet transplants and     to achieve insulin independence at one year after the final islet transplant.   "
120712|NCT01705886|"     The purpose of this study is to document and compare the surgical and after surgery costs,     recovery time, and outcomes of two procedure types:        -  Robotic assisted surgery replacing one compartment of the knee        -  Manual (robot is not used) surgery replacing all three compartments of the knee (total          knee replacement)      The hypothesis is that robot assisted partial knee replacement is cost effective and provides     clinical outcomes that are equivalent to a manual total knee replacement.   "
120713|NCT01705873|"     The objective of this study is to evaluate changes in Framingham score (from low to moderate,     from moderate to high) based on changes in lipid profile and other parameters from baseline     to 48 weeks of HAART in naïve patients or patients in second line of treatment, considering     LPV/r vs EFV based HAART. The null hyphotesis is that there is an increased Framingham score     in patients treated with LPV/r as second line treatment and in patients treated with LPV/r or     EFV regimen as first line treatments.   "
120715|NCT01705847|"     This study is to determine the appropriate dosing regimen of GS-9820 in subjects with     lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study     evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.   "
120717|NCT01705821|"     This study is designed to measure forces applied using standard surgical instruments at the     skull base during resection of skull base lesions. This data will be useful for optimizing an     active canula robot for assisting in skull base surgery. We hypothesize that through     measurement of forces generated during routine endoscopic skull base surgery we will be able     to optimize the canulas of an active canula robot for skull base surgery.   "
120718|NCT01705808|"     Severe sepsis and septic shock are life threatening medical emergencies and are among the     most significant challenges in critical care. Case reports and case series suggest that     plasma-derived protein C concentrate may improve the outcome of patients with acquired     protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway in     modulating overwhelming inflammation and preventing coagulation derangements, two key     mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience     collected through these studies shows that PC is safe, in that it is not associated with     bleeding or severe allergic complications,and possibly useful, at least to improve the     coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes     from case series or case reports or an underpowered randomized controlled study. A randomized     clinical trial, adequately powered for mortality or clinically relevant outcome, is necessary     to confirm PC efficacy.The aim of this study is to demonstrate that Protein C zymogen has     clinically relevant implications in terms of reduction of thromboembolic events, 30 days     mortality, length of intensive care and hospital stay, time on mechanical ventilation, length     of ICU and hospital stay. The study will also confirm that there is no bleeding concern with     the use of Protein C concentrates.The study drug will be administered in the Intensive Care     Unit for 72 hours and the patients observed till ICU discharge. Telephone followup will be     performed at 30 days and at one year.   "
120719|NCT01705795|"     Randomized, placebo-controlled, double-blind study evaluating the effect of anti-IL-5-therapy     in patients with bullous pemphigoid. The primary study objective is to determine the efficacy     of an anti-IL-5 monoclonal antibody therapy, administered as 750mg mepolizumab, in patients     with bullous pemphigoid.   "
120720|NCT01705782|"     The purpose of the study is to investigate the metabolic effects during acute inflammation     with and without the nutritional supplement of amino acids.      E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.      The study is an interventional randomized placebo study including 8 healthy male subjects.     Each subject participates 3 times (different days) and are given one of following     interventions:        -  Placebo (NaCl)        -  Endotoxin, US standard reference E.Coli + Placebo (NaCl)        -  Endotoxin, US standard reference E.Coli + Amino acids (intravenously)      It is our hypothesis that the nutritional intervention during acute inflammation plays an     important role in lipid and protein metabolism.   "
120721|NCT01705769|"     This project aims to assess the efficacy of three options under consideration in India for     home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a     multi-center randomized controlled trial to determine the efficacy of two community-supported     home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF)     for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented     home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and     will have enough statistical power to detect a 15% or greater difference in recovery rates     between either one of the intervention groups compared with comparison group.   "
120744|NCT01705470|"     The study Objective is to assess the clinical and echocardiographic changes of patients with     systolic dysfunction receiving blood transfusion, with or without prior treatment with     furosemide   "
120745|NCT01705457|"     The aim of this study is the comparison between the effects of supplementation with 25000 IU     preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor     expression.   "
120722|NCT01705756|"     FMF is the most common periodic fever with a worldwide patient population estimated as     150,000, mainly located in the Eastern Mediterranean basin. colchicine is the established     therapy of choice ,however, around 20.000 patients worldwide fail to respond or cannot     tolerate therapeutic doses, thereby suffering from recurrent debilitating, severe, painful     attacks of peritonitis, pleuritis and synovitis and are at risk to die from reactive     amyloidosis .Mutation-induced reduction in pyrin/ marenostrin activity is thought to underlie     the disease by leading to NALP3 inflammasome activation ,and thereby to IL-1β related burst     of inflammation.      The IL-1 receptor antagonist Kineret (Anakinra), seems to be the most appropriate response to     the uncontrolled IL-1β elevation. Indeed, an increasing number of reports over the last few     years indicate a good response to Kineret (Anakinra), in colchicine-resistant FMF ,also in     children ,however, no controlled study has thoroughly evaluated the efficacy and safety of     this treatment.      Study outline:      The study aims to run at the FMF centre in Sheba Medical Center, covering more than 10,000     patients. The study will evaluate the effect of recombinant IL-1 receptor antagonist, Kineret     (Anakinra), on the frequency of FMF attacks in patients that, despite maximum tolerable dose     of colchicine, present with more than one attack per month.      The study is designed as a randomised, placebo-controlled, double-blind study. 50 patients     will be randomised to treatment with either Kineret (Anakinra), or placebo treatment for 4     months.   "
120723|NCT01705743|"     In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide     on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined     with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects     (MACie) in middle aged subjects.   "
120724|NCT01705730|"     This observational study will evaluate the use and efficacy of RoActemra/Actemra     (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid     arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the     licensed label will be followed for 6 months.   "
120725|NCT01705717|"     This retrospective, observational study will assess the real world treatment out comes in the     management of patients with chronic hepatitis C. No prospective ass essment or procedure with     patients during this study will be conducted. Data wil l be collected from patient medical     records of the year 2000-2011.   "
120726|NCT01705704|"     This retrospective study will evaluate the association of biomarkers and the treatment     response of patients with chronic hepatitis B, who have completed therapy with Pegasys     (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from     patients will be used; no actual patients are involved.   "
120751|NCT01705379|"     A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure     requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety     evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving     MenACWY-CRM vaccination according to routine clinical practice and prescribing information.   "
120727|NCT01705691|"     NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel     followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with     HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in     the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary     aim of the study is to determine the pathologic complete response (ypCR) in breast and     axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include     determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after     eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year     recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant     regimens.   "
120728|NCT01705678|"     There is some evidence that dietary supplementation with fish oil has health benefits,     especially in respect of some of the known risk factors for cardiovascular (heart) disease     such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable to     validate alternative sustainable sources of the important omega−3 fatty acid components. It     has been suggested that oil from krill, which are small marine crustaceans, may be as     effective or possibly more beneficial than fish oil, and may provide a more effective and     beneficial supplement. Dietary management of cardiovascular health parameters (such as blood     lipids)is becoming more and more important as the rising trends in obesity nationally and     worldwide are leading to escalating incidence of diabetes and heart disease. The     investigators propose to use some specific novel lipid measurements of cardiovascular risk to     test this possibility in a group of men who, although generally healthy, show some risk     factors in terms of their weight and metabolic profile.This pilot study will provide     preliminary data to show whether krill oil has similar or different effects from fish oil on     the cardiovascular health of overweight but otherwise healthy men, and in particular will     provide detailed information on alterations in novel lipid markers of cardiovascular disease,     which may be a better diagnostic tool than classical lipid measurements (e.g. serum     cholesterol). The investigators have been developing and validating new techniques to measure     emerging lipid markers of cardiovascular risk accurately and will continue to develop and     investigate these techniques during the course of this project. The investigators hypothesise     that krill oil will be more efficacious in reducing markers of risk relating to     cardiovascular disease.   "
120729|NCT01705665|"     This study was initiated on the preliminary premise that a thrombus whose formation was     triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue     factor initiated thrombus), may evolve differently than the one evolving at the site of a     recently implanted stent (foreign body triggered). Consequently, the thrombus composition of     a de novo clot could differ from the other one, extracted during the occurrence of a subacute     thrombosis, regarding the number of various cells, the amount of fibrin and platelet     aggregates and the relationship among these components. In addition, it seems relevant to     evaluate the numbers and the distribution of the local monocytes, once these cells may     interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1]) and by the     extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a     distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary     arteries, and may have clinical implications.   "
120976|NCT01702441|"     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and     pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections     daily for 28 days in patients with diabetic macular edema (DME).   "
120733|NCT01705613|"     The first objective is to measure the QALYs (Quality Adjusted Life Years) of Brazilian     children and adolescents, submitted to methylphenidate immediate-release treatment for     Attention Deficit Hyperactivity Disorder (ADHD). For this, the Health Utility Index scale     (HUI) will be completed by the patient and/or family, in two moments of an observation study     with immediate-release methylphenidate: at the baseline and 6th month of treatment in the     follow-up. The results provides information to calculate the utility measure and determine     the QALYs (Quality Adjusted Life Years). After this, for the cost-effectiveness of the     treatment, it will be used a Markov model of decision analysis, and a Monte Carlo simulation     with 10,000 random trials.      Subjects will be submitted to immediate-release methylphenidate treatment in a maximum dose     of 0.5mg/kg/day. The total treatment monitoring is 06 (six) months, and patients will be     evaluated at baseline, first, third and sixth month. The HUI rating scales are fulfilled by     parents and patients (if >12 years old only) at baseline and 6th month. The period for     inclusion of new patients comprises from 01/01/2011 to 31/12/2013.   "
120734|NCT01705600|"     The primary goal of this study is to examine the effects of limiting complaints on pain and     pain catastrophizing (PC) in individuals with low back pain (LBP) who are in a state of     central sensitization (CS).      The study will be performed on individuals who have LBP and are in a state of CS. CS is     classified as a type of pain which has the following dominant features: pain that is     disproportionate to the nature or extent of injury/pathology; disproportionate,     non-mechanical, unpredictable pattern of pain provocation in response to aggravating/easing     factors; strong association with maladaptive psychological factors      ; diffuse/non-anatomic areas of pain/tenderness to palpation. These criterion have been     demonstrated to have discriminative validity for diagnosing CS.   "
121385|NCT01697072|"     This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of     epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced     MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma   "
120735|NCT01705587|"     This open label comparison study examines the hypothesis that teriparatide given immediately     following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will     enhance healing and improve bone mineral density compared to delayed treatment (after six     months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or     for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition     will have greater quality of life measures and less pain compared to those with delayed or no     therapy.   "
120736|NCT01705574|"     This study will evaluate the safety, efficacy, and tolerability of a regimen containing     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)     fixed-dose combination (FDC) versus ritonavir (RTV)-boosted atazanavir (ATV) plus     emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) in HIV-1 infected,     antiretroviral treatment-naive adult women.      This study will consist of two phases: Double-Blinded Treatment Phase (48 weeks) and     Open-Label Extension (OLE) Phase (48 weeks).      After 48 weeks of blinded treatment, participants will continue to take blinded study drug     for 12 weeks and return for an Unblinding Visit at Week 60. Participants who are     virologically suppressed at Week 48 during the Double-Blinded Treatment Phase will have the     option to enter the OLE Phase.   "
120737|NCT01705561|"     -  Assess the attitudes and feelings of premenopausal Latin American women towards the risk          of loss their fertility by adjuvant chemotherapy.        -  Correlate the attitudes with other variables including age at diagnosis, already having          children, number of children, level of instruction, marital status, frequency of          menstrual cycle.   "
120738|NCT01705548|"     This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in     treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays     directly to the tumor and cause less damage to normal tissue. Giving fractionated     stereotactic radiosurgery may kill more tumor cells   "
120739|NCT01705535|"     Fecal incontinence is the complaint of involuntary loss of feces. Fecal incontinence affects     2-12% of the adult population. It is a hidden problem - less than one third of the affected     persons discuss the problem with their doctor. The condition has a negative effect on quality     of life. It is associated with shame and limitation in social life, leisure, occupational and     sexual activities.      Pelvic floor muscle exercises with or without the use of biofeedback has been recommended and     used for the treatment of fecal incontinence over the last decades. Several uncontrolled     trials and some controlled trials have shown a positive effect of this training, but most of     the trials are small and/or have methodological problems. Therefore there is to day still a     lack of sufficient evidence for the effect of pelvic floor muscle exercise as a treatment of     fecal incontinence.      The aim of this study is to compare the effect of an individual physiotherapeutic supervised     pelvic floor muscle training program with a control physiotherapeutic treatment (massage of     the neck and back). Both treatments will be given parallel with standard information and     guidance given by a nurse specialized in anal incontinence issues.      Study hypothesis: Pelvic floor muscle exercises given parallel with standard advice and     guidance by a specialized nurse, provides better effect to reducing fecal incontinence than     control treatment and standard advice alone.   "
120740|NCT01705522|"     The investigators intend to assess the role of several biomarkers in the prediction of     relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive     score will be derived in order to assess the relapse risk at 1 year.   "
120741|NCT01705509|"     This is a proof of concept trial using ranolazine, a medication, in patients with known     Coronary Artery Disease and reduced left ventricular function, EF < 40%. We propose that     ranolazine therapy will result in demonstrative improvements in cardiac function that can be     objectively assessed using the parameters measured with CPET. We propose that demonstrative     improvement in CPET parameters on ranolazine will translate into improved patient outcomes     for this patient population.   "
120742|NCT01705496|"     This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic     imaging agent for the detection of prosthetic joint infections in patients.   "
120743|NCT01705483|"     The purpose of this study is to determine the safety and tolerability and pharmacokinetics of     ASP9853 combined with docetaxel or with paclitaxel in subjects with advanced non-hematologic     malignancies.   "
120746|NCT01705444|"     Acute urinary retention is considered one of the most common problems in the older age,     especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary     retention using the Foley catheter still causes problems at the level of patient movement and     the daily exercises. However, with the emergence of a new device, the spanner, investigators     believe that many of the above mentioned problems can be resolved. This tool may provide more     freedom for the patient.   "
120747|NCT01705431|"     The purpose of the On Track intervention is to address a need raised by a day-treatment     school in Lane County: Support for students transitioning from the day-treatment school (Lane     School) to their district middle schools. Eligible students are currently attending Lane     School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are     preparing to transition to their district schools.   "
120748|NCT01705418|"     Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up   "
120749|NCT01705405|"     Visualize surgical needles inserted in the prostate, under the ultrasound modality.   "
120750|NCT01705392|"     The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard     chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to     evaluate the predictive value of a set biomarkers associated with vascular endothelial growth     factor (VEGF) dependent angiogenesis. Also, we aim to identify mechanisms causing acquired     resistance to treatment with bevacizumab and escape mechanisms caused by other angiogenic     growth factors than VEGF. Finally, we want to analyze safety and influence on outcome     variables by primary prevention of bevacizumab induced hypertension by low dose beta blockers     in comparison with an ACE inhibitor.   "
120752|NCT01705366|"     The objective of this study is to document the demographic and clinical characteristics and     the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.      The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the     knee joint has 10 year implant survival and clinical outcomes that are equivalent to other     knee replacement systems.   "
120753|NCT01705353|"     The purpose of this study is to measure the presence of HMGB-1 and other proteins in the     blood across five time points after stroke, and to determine if their presence correlates     with rate of stroke recovery.   "
120754|NCT01705340|"     This phase I trial studies the side effects and best dose of Akt inhibitor MK2206 and     lapatinib ditosylate when given together with trastuzumab in treating patients with locally     advanced or metastatic human epidermal growth factor receptor-2 (HER2)-positive breast,     gastric, or gastroesophageal cancer that cannot be removed by surgery. Akt inhibitor MK2206     and lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes     needed for tumor growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth     in different ways. Some block the ability of tumor cells to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Giving Akt     inhibitor MK2206 and lapatinib ditosylate together with trastuzumab may kill more tumor     cells.   "
120755|NCT01705327|"     This is an observational, multi-center study to assess clinical features and biologic     biomarkers in Parkinson's disease (PD) patients compared to healthy controls (HC). The     primary objective of this study is to discover clinical and biologic markers of PD for use in     clinical trials of disease-modifying therapies.   "
120756|NCT01705314|"     The goal of this study is to assess the effectiveness of vitamin D in reducing     laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract     infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha     Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly     vitamin D supplements or placebo. Participants who develop acute respiratory infection over a     12-month period, will be tested for influenza, the co-primary outcome, and other respiratory     viruses, the other co-primary outcome, by RT-PCR.   "
120757|NCT01705301|"     In this study, the investigators will monitor extracellular neurotransmitter levels using a     probe that is able to perform real time electrochemical detection during deep brain     stimulation surgery. The overall question this study is designed to answer is: Are there     neurotransmitters released during deep brain stimulation?   "
120758|NCT01705288|"     Over 600,000 hysterectomies are performed annually in the United States. Despite increasing     use of less invasive approaches, the majority of hysterectomies are still performed via     traditional laparotomy, which can be associated with generally slower recovery and longer     lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize     post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as     possible following surgery.   "
120759|NCT01705275|"     A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity     in healthy male adult volunteers.   "
120760|NCT01705262|"     The purpose of this study is to determine whether Moviprep or Phosphoral is the best method     of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.   "
120761|NCT01705249|"     This study is conducted in Europe. The aim of this study is to investigate the bleeding     profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone     acetate (NETA)).   "
120762|NCT01705236|"     This is a 3-year, prospective, multi-center, open-label study to describe the long term     changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment     with Fingolimod. It is designed to longitudinally study the degeneration of retinal axons by     measuring change in RNFL thickness by latest OCT-technology. Correlations of OCT findings     with available MRI data and clinical findings may enhance our understanding of the     relationship between CNS inflammation, tissue injury, regeneration and neurological deficit     in the context of fingolimod therapy.   "
120763|NCT01705223|"     This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by     recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk     of HIV infection. In addition, the effect of different intervals of the prime-boost will be     studied.   "
120977|NCT01702428|"     The purpose of this study is to evaluate consistency in terms of the immune response to three     different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies,     and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use     in the United States (US).   "
120764|NCT01705210|"     The exact neuronal mechanism underlying the cognitive decline associated with diabetes     mellitus type 2 (DM2) still remains to be elucidated. Multi-parametric functional MRI can     potentially provide functional, micro-structural, micro-vascular, and metabolic information     on the affected brain at an earlier stage than does conventional structural MRI. The overall     aim of the current proposal is to obtain a better understanding in the neuronal mechanisms     that underlie cognitive decline in DM2 and the putative prediabetic condition the metabolic     syndrome (MetS).   "
120765|NCT01705197|"     The objective of this study is to evaluate the safety and efficacy of Avanafil in the     treatment of erectile dysfunction with moderate to severe in subjects. And, this is to     additionally confirm the efficacy and safety after initiating treatment with Avanafil 100mg     and later increasing to 200mg, compared with continuing treatment with Avanafile 100mg, in     subjects.   "
120766|NCT01705184|"     At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with     platinum eventually associated with bevacizumab. A new treatment begins at progression.      In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could     be administered according to a stop and go strategy respecting therapeutic breaks between     sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance     is possibly better than an absence of treatment. These plans benefit to the patients in terms     of efficiency but also in terms of toxicity, in particular neurological.      The question is to know if this strategy is feasible in lung cancer.   "
120767|NCT01705171|"     In this study we will investigate the expression of the fructose transport protein GLUT5 in     the small intestine in patients with functional GI disoders and fructose intolerance compared     to matched healthy controls.   "
120768|NCT01705158|"     The purpose of this study is to determine the efficacy and the safety of the association of     carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive     to platin.   "
120769|NCT01705145|"     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and     pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5     years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at     least 1 allele.      Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor     in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is     designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through     5 years of age.   "
120770|NCT01705132|"     The purpose of the study is to determine if there are certain laboratory tests that can be     performed to detect substances or features in a child's urine that can be used to measure the     progress of Alport kidney disease and the effects of treatment. These tests and their results     could be of use to measure responses to new treatments in future clinical trials.   "
120771|NCT01705119|"     The purpose of this study is to investigate how changing from a supine to upright position     affects gas exchange for patients with hypoxemic respiratory failure.      The research question is: will oxygen saturation and/or partial pressure of oxygen in the     blood change when a patient with hypoxemic respiratory failure moves from a supine to upright     position?   "
120772|NCT01705106|"     This clinical trial studies capecitabine and celecoxib in treating patients with solid     malignancies that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy,     such as capecitabine, work in different ways to stop the growth of tumor cells, either by     killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and     celecoxib together may be an effective treatment for solid malignancies.   "
120773|NCT01705093|"     The prevalence of childhood obesity has been increasing over the past couple of decades.     Similar to adults, overweight and obesity in young children and adolescents is associated     with an increased number of cardiovascular risk factors including dyslipidemia, hypertension,     insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that     foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea,     citrus fruits, and strawberries are protective against the development of cardiovascular     disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols,     flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have     observed that these isolated compounds, as well as strawberry extracts have the potential to     affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling     and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in     select measures of cardiovascular function in overweight and obese adolescent males.   "
120774|NCT01705080|"     The purpose of this post market clinical investigation is to further evaluate the safety and     performance of the EnligHTN™ Renal Denervation System in the treatment of patients with     uncontrolled hypertension.   "
120775|NCT01705067|"     Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with     degenerative knee disease requiring primary total knee replacement.   "
120776|NCT01705054|"     The purpose of this study is describe the frequency of chest pain and how chest pain impacts     patients' quality of life in the outpatients with chronic coronary artery disease in     contemporary cardiology practice settings.   "
120777|NCT01705041|"     The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase     test with the standard of care test used in an HIV clinic at the Hospital for Tropical     Diseases in Ho Chi Minh City, Vietnam.   "
120799|NCT01704742|"     This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's     lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses     like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma     Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will     let the resesarchers look at their medical record, follow their normal cancer care, and have     blood drawn to look at different proteins and viruses. Researchers would also like to look at     part of the original tumor that was taken out of each patient. Some of these samples will be     stored at Kenyatta National Hospital and research will be done on them later. This study does     not involve any change in treatment, but only allows the study team to follow how a patient     in Kenya with lymphoma is treated.   "
120778|NCT01705015|"     The aims of this 3-year randomized, single-blinded clinical trial are to compare the effect     of high and low feedback about performance on the bedside exercise device in heart or liver     transplantation recipients during the hospitalization immediately after transplantation. The     hypotheses of the study are heart/liver transplantation recipients who have high feedback     about performance on the bedside exercise device will progressively increase their level of     exercise over the course of their hospitalization, more independent in ambulation level,     better walking speed and 6-minute walk test at discharge, and better cardiorespiratory     fitness at 4-8 weeks after transplantation than those who receive low feedback. The adult     patients who newly receive heart or liver transplantation at National Taiwan University     Hospital will be evaluated for eligibility of the study in the acute postoperative period.     The study will be conducted in both the intensive care unit and ward environments. The study     subjects will be randomized to either high or low feedback about performance on the bedside     exercise device which uses hand/foot pedals that record exerted forces against adjustable     resistances, measure repetitions of upper and lower extremity cycling movements, and give     feedback about performance via a wireless internet connection. The study will also monitor     the amount of daily movement activity of all subjects in this trial by using triaxial     accelerometers, and the activity recognition algorithms developed by engineers and computer     scientists at University of California Los Angeles. The outcome measures include level of     independence for walking, walking speed, 6-minute walk test, and cardiopulmonary exercise     testing by the blinded observers. The study expects to enroll at least 50 heart     transplantation recipients and 60 liver transplantation recipients in 3 years. The results of     this study will offer much insight into activity levels of heart or liver transplantation     recipients during early postoperative period. Besides, heart transplantation recipients will     receive routine phase I cardiac rehabilitation program by the physical therapists during the     study but not liver transplantation recipients. We might be able to evaluate the interaction     effects of routine physical therapy and UCFit exercise among our study subjects. Our data     will also provide insight into just how active or inactive transplantation recipients may be     and help generate ideas of organ transplantation rehabilitation program to increase their     fitness-related activity prior to discharge.   "
120779|NCT01705002|"     This is a Phase I, multi-center, Dose-Escalating, Safety Study of an Intravenously     Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PL-MLP, PROMITIL) in Cancer     Patients with Solid Tumors. The study comprised of:      Escalated cohorts A-H: 27 male or female participants, ages 18-80, BMI 18-36 diagnosed with     inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have     failed to respond to standard therapy or for whom no standard therapy is available. Eligible     subjects will be assigned, successively in order of accrual, to one of eight cohorts, to     receive escalating doses of intravenously infused PROMITIL. PROMITIL will be administered as     an intravenous infusion. Dose escalation will only proceed in the absence of dose-limiting     toxicity (DLT). For this purpose, each cohort will only begin its first cycle of PROMITIL     when the cohort preceding it has successfully completed its first 4-week cycle without any     signs of DLT.      Expanded cohort: 17 adult patients with metastatic CRC. The purpose of this expanded cohort     is to further evaluate the safety of Promitil and to search for signs of antitumor activity     of Promitil in this specific patient population.      Combination Cohort (Promitil concomitantly with Capecitabine): 23 adult patients with     metastatic CRC.      Triple combination Cohort: 13 additional subjects with metastatic CRC, received combination     of Promitil concomitantly with Bevacizumab (5 mg/kg) on day 1 of a 28 day cycle and     Capecitabine on days 1-14 of a 28 day cycle.      3 weekly cohort- 9 subjects with metastatic CRC will receive Promitil and Bevacizumab (7.5     mg/kg) on day 1 of a 21 day cycle.   "
120780|NCT01704989|"     A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk     factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for     approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this     region an ideal setting for studying patients with this condition. Despite associated high     morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for     the clinician. Topical medical therapy is less effective than for primary open angle glaucoma     and patients often require early surgical therapy, with associated risks. Selective laser     trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma,     although the evidence for this is presently lacking. The aim of the current study is to     provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical     therapy, in the management of pseudoexfoliative glaucoma.   "
120781|NCT01704976|"     This randomized controlled study aims to examine long term effects in the skilling up phase     over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance     therapy intervention in a frail elderly population.   "
120782|NCT01704963|"     The purpose of this study is to evaluate the safety and tolerability of Bruton's Tyrosine     Kinase (Btk) Inhibitor PCI-32765 in Japanese patients with recurrent mature B-cell neoplasms.   "
120783|NCT01704950|"     The aim of this study is to provide data and the guidelines for the use of IDRT SL in small     wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of     this product as a one stage procedure.   "
120784|NCT01704937|"     Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a stool     transplant from a healthy individual to a C. difficile-infected recipient, and has long been     a successful approach to recurrent/refractory C. difficile. The purpose of this project is to     generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used     repeatedly, particularly in those who do not have a healthy intimate partner or other related     donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by     the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a     frozen inoculum administered by nasogastric tube vs administered by colonoscope.      Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via     either:        -  colonoscopy        -  NGT      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,     systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.     difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a     normal bowel status for the individual. Secondary efficacy endpoints include weight,     subjective well-being and relative clinical improvement per standardized questionnaire, and     subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects     will be monitored for clinical safety by history and standard exams and the follow-up     questionnaire as well as followed closely by phone and in person.   "
120785|NCT01704924|"     This study aims to assess the quality of wound healing in abdominal scars with and without     the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved     wound healing with less swelling, bruising, and inflammation, as well as less potential for     infection, seroma, and dehiscence.   "
120786|NCT01704911|"     The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the     transradial coronary intervention (TRI) in comparison with the transfemoral coronary     intervention (TFI).   "
120800|NCT01704729|"     Phase I: Focus groups on different designs of adjustable glasses and standard glasses     (August-September 2012) Phase II: Two-month randomized trial comparing four groups:     (September 2012 - August 2013)   "
120787|NCT01704898|"     The primary objective of this study is to determine the average bioequivalence of a generic     efavirenz 600 mg tablet (test formulation)compared with Stocrin(R) 600 mg tablets (Reference     formulation).The study is designed as an open label, randomized, crossover, 2-treatments,     2-period, 2-sequence, single dose pharmacokinetic study conducted in healthy volunteers.     Subjects will be randomized to receive generic efavirenz 600 (Test formulation) or Stocrin(R)     600 tablets (Reference formulation)on study day 1 (period 1). Subjects will undergo a 24 hour     intensive pharmacokinetic evaluation after ingesting a single dose of either the Test or     Reference formulation. Subjects will provide additional pharmacokinetic samples 36, 48, 72,     120 and 192 hours postdose, respectively. Subjects will complete a wash out period from day 8     to day 28 during wich no study drug will be ingested. On day 29 subjects will ingest either     the Test or the Reference formulation (opposite to the formulation received on period 1). All     subjects undergo another 24 hour intensive pharmacokinetic evaluation and pharmacokinetics     samples on days 36, 48, 72, 120, 192 pos dose, respectively. Adverse events and and     concomitant medication will be documented throughout the study.   "
120788|NCT01704885|"     The goal of this study is to determine whether a brief (three 20-30 minute session)     cognitive-behavioral play intervention will improve coping skills and adjustment for siblings     of children diagnosed with cancer.   "
120789|NCT01704872|"     The purpose of this study is to assess the safety, pharmacokinetic and activity profiles of     the ch14.18 antibody produced in cells of hamster origin (ch14.18/CHO).   "
120790|NCT01704859|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in     25,874 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study is being conducted among participants in VITAL and will     examine whether vitamin D or fish oil will (1) reduce incident total fractures and (2) reduce     incident hip and non-vertebral fractures.   "
120791|NCT01704846|"     The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI     201335 NA soft gelatine capsules.   "
120792|NCT01704833|"     The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused     Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of     persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.   "
120838|NCT01704235|"     The purpose of this protocol is to understand the extent of symptom perception and preventive     care-seeking among Vietnamese American women and their impact on cervical cancer screening     from the perspectives and experiences of key informants including primary health care     providers and Vietnamese American women (VAW, foreign-born and United States-born). With this     information, the investigators can better understand how to promote cervical cancer screening     in the Vietnamese community.   "
120793|NCT01704820|"     Colonoscopy is the gold standard screening test for colorectal cancer. Removal of     pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over     50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon     cancers, it provides only limited protection from cancer in the proximal (right side) colon.     Our goal is to determine if additional pre-cancerous colon polyps can be identified by     looking at the right side of the colon in retroflexion. During retroflexion the tip of the     colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If     additional polyps can be identified in this manner colonoscopy will become a more efficient     method of screening for colon cancer.      In order to evaluate how effective right colon retroflexion is at detecting polyps in the     proximal colon we plan on performing a randomized, controlled trial. Patients undergoing     screening or follow up colonoscopy will be invited to participate in the study. Those     patients who agree to participate will be randomized into one of two groups once the     colonoscope is fully inserted. Group one will have the right side of their colon examined for     polyps with the endoscope looking forward (traditional form of examination) followed by     repeat examination of the right side of the colon with the colonosocpe in retroflexion     (looking backwards). Polyps seen during each section of the exam will be removed and manner     in which the polyps were found/ removed will be recorded. Following the two exams of the     right side of the colon the colonoscopy will be completed in the usual manner. The duration     of each portion of colonoscopy will be recorded. After the procedure is completed the     physician performing the colonoscopy will rate difficulty of the procedure and confidence     with quality of the examination. Pathology results for each polyp will be recorded once     available. There will be no study related follow up after the pathology results are recorded.   "
120794|NCT01704807|"     Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo     foot inserts on the duration of chiropractic correction of spinal fixations and muscle     imbalances using applied kinesiology techniques.   "
120795|NCT01704794|"     The purpose of this study is to determine the antioxidant effect of prolonged use of sorghum     bicolor (jobelyn) to increase the level of plasma superoxide dismutase and glutathione     reductase in patients with sickle cell disease and to determine if there is any improvement     in the quality of life of the patients.   "
120796|NCT01704781|"     During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced     immunological response and ultimately immune deficiency. Vacc-4x is a peptide-based HIV     immunotherapy and the primary objective is to strengthen the immune system's response to HIV     p24. By adding Lenalidomide, an immunomodulatory agent, as a supporting drug, it is     anticipated that the effect of Vacc-4x might be enhanced.   "
120797|NCT01704768|"     The prevention and treatment of obesity and mental health disorders in adolescence are two     major public health problems in the United States today. To address the increasing incidence     and adverse health outcomes associated with both obesity and mental health problems, a     theory-based 15 session intervention program entitled COPE (Creating Opportunities for     Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions & Exercise), will     be delivered within high school health classes in order to improve the physical and mental     health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).   "
120798|NCT01704755|"     The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267     (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and     ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus     (HCV) genotype 1-infected adults with compensated cirrhosis.   "
120812|NCT01704573|"     This positron emission tomography (PET) study examines the effects of 24 hours abstinence     from smoking on return to availability of neuronal nicotinic receptors in slow and fast     metabolizers of nicotine.   "
121043|NCT01701570|"     The investigators plan to learn more about how different levels of exercise feel to people     with Type 2 Diabetes and how it feels to people without Type 2 Diabetes. This study team will     also look at what causes exercise to feel harder or easier to people with and without Type 2     Diabetes. The investigators will also compare the potential benefits of supervised exercise     training to that of diabetes education/blood sugar monitoring.   "
120801|NCT01704716|"     This is a randomised study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk     neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified     > 12 months at diagnosis).      The protocol consists of a rapid, dose intensive induction chemotherapy (R3 randomisation -     Rapid COJEC vs modified N7), peripheral blood stem cell harvest, attempted complete excision     of the primary tumour, myeloablative therapy (BuMel) followed by peripheral blood stem cell     rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomisation -     isotretinoin and ch14.18/CHO, with or without aldesleukin (IL-2).      In the induction phase, all patients with stage 4 neuroblastoma and those with stage 4s     MYCN-amplified neuroblastoma will be randomised (R3) to Rapid COJEC or modified N7; localised     patients receive Rapid COJEC (Rapid COJEC is given with G-CSF support based on the results of     the R0 randomisation running between 2002 and 2005).      Following induction treatment peripheral blood stem cell harvest (PBSCH) will be performed     and complete excision of the primary tumour will be attempted.      Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the     end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.      After Rapid COJEC induction, localised patients will proceed to consolidation. Patients aged     12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without     segmental chromosomal alterations (SCA) are thought to have a good prognosis and will stop     treatment after induction therapy and surgery to the primary tumour.      Consolidation consists of BuMel MAT (following the results of the R1 randomisation) followed     by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary     tumour.      During the immunotherapy phase, patients will be randomised (R4) to immunotherapy with     isotretinoin (13-cis-RA) and ch14.18/CHO, with or without aldesleukin (IL-2).   "
120802|NCT01704703|"     Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next     generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory     to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly     sensitive techniques.   "
120803|NCT01704690|"     Esophageal cancer is one of the common malignant disease, especially in China. The annual     incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The     prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at     diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%.     Though some patients received surgical treatment, disease will recurrent and metastasis in     nearly 90% of the patients.      In past decades, there isn't much improvement of the outcome and survival of advanced     esophageal cancer due to the lack of effective chemotherapy agents. The traditional     chemotherapy drugs include 5-fluorouracil and cisplatin and the combination of them results     in a 25-35% response rate in both first-line and palliative treatment. Paclitaxel plus     cisplatin regiment is another promising treatment of esophageal cancer and have been proved     effective in many studies. One of our previous study showed paclitaxel and cisplatin     treatment resulted in encouraging response rate with manageable side-effects in 131 patients     of advanced esophageal cancer.      However, the toxicities of paclitaxel and cisplatin limit their combination in clinic. For     example, the polyoxyethylene castor oil paclitaxel could induce acute hypersensitivity     reactions and neurotoxicity. Cisplatin could result in dysfunction of kidney and     neurotoxicity. In addition, most of esophageal cancer patients are age 65 to 70. Many of them     have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease     which cause varying damages of renal function and limit the use of cisplatin in these     patients. Therefore, it is urgent for doctors to seek an alternative of cisplatin in the     combination chemotherapy treatment.      Therefore, the investigators designed this randomized clinical trial in which a novel     combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in     compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and     toxicity. The investigators hope this study will provide some clues for the treatment of     esophageal cancer patients.   "
120804|NCT01704677|"     During the past 25-30 years, surgery with total disc replacement (TDR) has become an option     for a selection of patients with chronic low back pain (LBP) traditionally treated     conservatively or operated on with spinal fusion. Randomized trials comparing TDR with fusion     have found the clinical outcome of TDR at least equivalent to that of fusion, and the only     study comparing TDR to non-surgical treatment (The Norwegian TDR study) concludes that TDR is     significantly more effective than multidisciplinary rehabilitation (REHAB) after 2 years.     However, the long-term effects of TDR in terms of clinical results, costs, reoperation- and     revision rate, degenerative changes and prognostic factors have not been investigated in high     quality prospective trials. This is very much required since TDR surgery is offered a great     number of patients world wide, and is associated with high complexity and risk of serious     complications and difficult revision. Hence, the overall aim of the present study is to     evaluate the long term (eight years follow-up) effect of The Norwegian TDR study where TDR     surgery were compared to modern multidisciplinary rehabilitation in patients with chronic low     back pain and localized degenerative disc changes.   "
120805|NCT01704664|"     Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity     and may improve quality of their life. Patients with gastric cancer will be divided into four     groups depending on the type of artificial nutrition. Group I (enteral feeding) and II     (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional     therapy during the postoperative period, group III (oral arginine) and IV (parenteral     immunonurition) patients will be treated nutritionally both prior to and after the surgery.     The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and     bactericidal activity of blood platelets will be determined before and after nutritional     therapy.   "
120806|NCT01704651|"     This study is designed to determine whether an oral perioperative medication (alvimopan--a     selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian     cancer.   "
120807|NCT01704638|"     The investigators will compare plasma kinetics of two marker drugs in individuals with     different genetic variations in the MDR1-gene. The hypothesis is that one group will have     higher exposure than the other.   "
120808|NCT01704625|"     PURPOSE The purpose of this research is to determine whether osteopathic manipulative therapy     (OMT) is a useful adjunct in evaluation and treatment of headaches.      PROCEDURES If a practitioner determines that a patient has a significant headache he/she may     order tests. He/ She may give the patient medications to treat the headache.      The investigators will also ask permission to evaluate and treat the headache using     osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation     and treatment will be performed by an emergency medicine resident. Osteopathic evaluation and     OMT is not standard of care for this condition. The investigators also may call the patient     in 7 days to see how they are doing.      The investigators wish to see if emergency medicine physicians can use osteopathic evaluation     and OMT to reliably treat headaches. The results of the examination and treatment will be     recorded, but will not be used to change treatment or to change additional tests. The     investigators wish to see whether in the future they can use OMT in certain cases instead of     or in conjunction with medications. The investigators plan on asking 50 patients to     participate.   "
120809|NCT01704612|"     Diabete animal studies demonstrated a longer period recovery after local anesthetic injection     (perineural administration). No clinical study demonstrated a prolonged nerve block duration     in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that     block recovery is delayed in diabetic patients.   "
120810|NCT01704599|"     Vitamins modulating homocysteine affect both TNF-alpha, vascular endothelial growth factor,     and theoretically enhance the anti-inflammatory version of NOS thus hopefully increasing the     efficacy and reducing the chance of some toxicities of adalimumab as determined by blood     testing and EKGs.   "
120811|NCT01704586|"     Thyroid nodules are a common clinical problem. Epidemiologic studies have shown the     prevalence of palpable thyroid nodules to be approximately 5% in women and 1% in men living     in iodine-sufficient parts of the world and up to 30% in iodine deficient regions, such as     Germany. The clinical importance of thyroid nodules rests with the need to exclude thyroid     cancer which occurs in 5-15%. Differentiated thyroid cancer (DTC), which includes papillary     and follicular cancer, comprises the vast majority (90%) of all thyroid cancers. In Germany,     approximately 7,000 new cases will be diagnosed in 2011. The yearly incidence has increased     from 3.6 per 100,000 in 1973 to 8.7 per 100,000 in 2002, and this trend appears to be     continuing. Recurrence-free survival is generally excellent and depends on the risk group.      The role of postoperative remnant radioiodine ablation (RRIA) as the most serious question     regarding the initial management of DTC still needs to be resolved even after decades of     radioiodine use. American Thyroid Association directions for future research addressing these     questions include:        -  Better understanding of the long-term risks of radioiodine use;        -  Improved risk stratification;      Randomized controlled trials are still missing in which RRIA has proven its worth as a safe     and very effective treatment that results in an improved life expectancy and a reduced     recurrence rate. Many observational studies lack sufficiently high evidence. Evidence grade     is rated mainly on expert level, based on non-randomized retrospective observation studies.     Although RRIA in Europe is established as adjuvant standard treatment for all patients with     DTC, except those with stage T1a, it remains to be shown throughout if it is beneficial for     low risk and medium risk patients without metastases (M0), also known as stage I patients     according to UICC/AJCC classification, accounting for 40-90% of all patients.      Blood doses due to cumulative radioiodine therapy may well exceed 2 Gy, and RRIA induces an     average blood dose of 0.28 Gy to the entire body. Risks as estimated from that dose are not     insignificant. The question is whether or not the condition after remnant ablation justifies     such an increased risk of a secondary malignancy. The probability of causation for a     pharyngeal or breast tumour can well exceed the margin of a 50% after being exposed to RRIA     or consecutive I-131 diagnostic imaging to explore measureable Tg levels. Even though     radioiodine therapy can benefit some patients with advanced thyroid carcinoma, it is still     unknown whether the risks of RRIA outweigh any discernable benefit. Undoubtedly, quality of     life may be affected by adjuvant use of I-131.      Study Hypothesis:      The I-124 study arm may have considerable benefits for the patient included in the study.     These include        -  enhanced tumour and risk stratification,        -  avoidance of unnecessary I-131 exposure in 30-89 percent of patients who were classified          with low risk tumour (MACIS or AMES scoring) or stage I disease (UICC-AJCC TNM          staging system), and,        -  improved quality of life at the same or better morbidity and mortality rates in the          I-124 arm.      Environmental and hospital staff related benefits include prevention or saving of I-131     exposure.      This study is designed to compare effectiveness of treatments following and evaluating     guideline recommendations in two assignment arms.   "
120813|NCT01704560|"     Well-informed potential subjects are presumably better able to make autonomous decisions     about the risks and benefits of participating in a research study than those in possession of     less information. In actuality, prior research into consent understanding suggests that     longer forms offering exhaustive information may inhibit rather than promote understanding.     Moreover, technical wording in tools used to measure parent understanding of research     permission may also lead to inhibition of understanding. This study will test the hypothesis     that, among parents of potential subjects for greater-than-minimal-risk research, two     modified and simplified subset of questions from the Deaconess Informed Consent Comprehension     Test (DICCT), one oral and open-ended and one written and multiple choice, will increase     subject understanding of the nature and risks of the research. The study will enroll the     parents of 40 potential neonatal research subjects with an interim analysis of data at 20     subjects. Subjects will review a sham research permission form and will be randomized 1:1 to     complete one of the two modified comprehension tests in addition to the DICCT (gold-standard)     test. Parents will be given an open-ended survey after the tests in order to qualitatively     describe their opinions of each test. A subset of parents who have received the written form     will also undergo a cognitive interview about the form. A similar subset will also be given     an open-ended survey about a proposed permission form cover sheet. The primary outcome will     be the correlation of scores between the DICCT and modified comprehension tests, following     the sham informed consent process.   "
120814|NCT01704547|"     The study is designed to assess the accuracy of patient breast reproducibly using the revised     BCID. This study would provide data for target verification and quality assurance to     eventually allow treatment of breast cancer patients for either a TBB or accelerated partial     breast irradiation. The BCID is a low-risk device similar to immobilization devices used     routinely in radiotherapy for other disease sites.   "
120815|NCT01704534|"     The purpose of this study is to determine whether ustekinumab is effective in the treatment     of moderate to severe hidradenitis suppurativa.   "
120816|NCT01704521|"     This study will examine viral dynamic responses in subjects with chronic hepatitis C and     hemophilia when treated with pegylated interferon + ribavirin and telaprevir.   "
120817|NCT01704508|"     Plasmodium falciparum causes malaria and approximately 665 000 deaths each year. chloroquine     and sulphadoxine-pyrimethamine resistant P. falciparum are widespread. An artemisinin     derivative combined with lumefantrine, amodiaquine or piperaquine is therefore recommended     for the treatment of malaria in Africa. However, artemisinin resistance appears to be     developing and resistance/tolerance to amodiaquine and lumefantrine exists. We are presently     conducting a study in Guinea-Bissau. Preliminary data indicates that the effectiveness and     availability of artemether-lumefantrine (AL), the 1st line drug, is poor. Consequently there     is a need for another treatment option. Dihydroartemisinin-piperaquine (DP) has been shown to     be efficacious and well tolerated in several African countries and is therefore such an     option. A clinical trial comparing the safety and efficacy of artemether-lumefantrine and     dihydroartemisinin-piperaquine is therefore needed.      Parents to children seeking Bandim Health Centre (CSB) with symptoms compatible with malaria     will be informed of the study. If accepting and the child fulfil the inclusion criteria, the     child will be randomised to treatment with either AL or DP. The treatment will be given     supervised at the health centre in the morning and the evening on day 0, day 1, and day 2.      At each visit and in the morning on day 3, the child will be examined, the mother asked for     any symptoms and signs of side-effects, the temperature measured. Furthermore, a blood sample     will be taken for examination of malaria parasites. On day 0 samples for measurement of     antimalarial drugs and for genotyping of the parasites will be taken on filterpaper. In a     subgroup of 50 children a blood sample for in vitro culturing and for analysis of the number     of leucocytes will also be taken.      After having finished the treatment the children will be followed on day 7 and then once a     week until day 42. At each visit the condition of the child will be examined and a     bloodsample taken for examination of parasites in the blood. Furthermore, a filterpaper     bloodsample will be collected for measurement of the drug concentration of if the child has     recrudescence for genotyping of the parasites. On day 0, 3 and 42 the haemoglobin level will     be examined.      The result of the two treatments will be evaluated by comparing the number of children with     recurrent parasitaemia, both corrected and uncorrected (recrudescence vs. reinfections). This     will be presented as adequate clinical and parasitological response rates PCR-corrected and     PCR-uncorrected. Furthermore, the chance in haemoglobin level from day 0 till day 3 and till     day 42 will be compared. The concentration of the antimalarial drug in the blood samples     taken at the visit before the re-parasitaemia will be capered to the concentrations in     children without re-parasitaemia.      Assuming a 20% loss to follow up a total of 346 children should be included. For the children     included, health care and medications at Bandim Health Centre will be free during the study     period but no other gifts or payments will be made.      Results will be presented to the staff at the Bandim health centre and the ministry of Health     and will be published in an international peer reviewed journal.   "
120818|NCT01704495|"     The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of     AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS)     and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma   "
120819|NCT01704482|"     We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal     dysfunction in patients with rheumatic valvular heart disease undergoing single valve     replacement.   "
120820|NCT01704469|"     Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive     sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but     conflicting. Previous clinical studies mostly used experimental or non-standardized surgical     stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized,     clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.   "
120821|NCT01704456|"     This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment     of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive     Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with     provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either     eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart.     The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is     more efficacious than an 8-session CBT intervention for decreasing women's pain intensity,     sexual distress, catastrophizing and hypervigilance towards pain.   "
120822|NCT01704443|"     This study aims to test the efficacy of a 4-session intervention (Group psychoeducational     treatment) using a randomized study design. Participants will be randomized in to 'immediate     treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session     IMPROVED treatment, just as women randomized to the experimental group, after the end of     their wait-list period.   "
120849|NCT01704092|"     The investigators hypothesized that dexmedetomidine as an anesthetic adjunct can be used in     the setting of off-pump coronary bypass procedure and can provide benefits to cardiac     function and cognitive performance on the ground of the dexmedetomidine's characteristics.   "
120850|NCT01704079|"     This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact     parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and     tolerability of CTAP101 will also be evaluated   "
121044|NCT01701557|"     Randomized trial to determine if the volume of fluid administration in pediatric patients     with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of     treatment   "
120823|NCT01704430|"     Patients undergoing heart surgery with a heart-lung machine (termed cardiopulmonary bypass)     are at an increased risk of having abnormal inflammation in their body after surgery. Such     inflammation can contribute to slower recovery from surgery, an increased risk of infection,     an increased risk of damage to organs other than the heart, and a more complicated course.      Prior research has suggested that using an oral protein supplement made of glutamine (an     essential amino acid normally found in your body) can reduce the risk of inflammation,     infection and the length of stay in hospital in patients who have suffered major trauma or a     burn injury. The investigators believe reducing such inflammation after heart surgery may     help promote recovery and reduce the risk of adverse events and complications.      The purpose of this preliminary study is to see if oral glutamine supplementation after heart     surgery is practical, and contributes to a reduction in inflammation. The oral glutamine     proposed in this study is based on what has been previously studied and what is considered     safe.   "
120824|NCT01704417|"     This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise     on blood glucose in subjects with type 1 diabetes, who are treated with either insulin     degludec (IDeg) or insulin glargine (IGlar).   "
120825|NCT01704404|"     This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects     with Chronic Obstructive Pulmonary Disease (COPD).   "
120826|NCT01704391|"     Open elective abdominal aortic surgery is a high risk procedure involving clamping of the     aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD)     causing lower limb ischaemia.      These patients are often regarded as one entity in postoperative study settings. However,     previous studies indicate that risk profiles, inflammatory activity, and haemodynamic     capacity may differ between these groups. The first aim of this study was to evaluate     postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising     that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute     dialysis than did patients with AOD.      The investigators see a relatively high incidence of postoperative acute kidney injury (AKI)     following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in     the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of     inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory     response to aortic cross clamping may per se induce a rise in NGAL despite intact renal     function. Therefore NGAL may not be a reliable marker of AKI after AAS.      The second aim of this study is to describe the changes in NGAL after AAS in patients with     and without postoperative dialysis-dependent AKI.   "
120827|NCT01704378|"     This trial is conducted in Europe. The aim of this trial investigate the the long-term safety     of biphasic insulin aspart 30 in subjects with type 2 diabetes.   "
120828|NCT01704365|"     The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein     nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.   "
120829|NCT01704352|"     Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases.     Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive     behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not     been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral     therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators     hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor     mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and     insomnia.   "
120830|NCT01704339|"     Critical ischaemia is pain at rest as the result of poor blood flow and lack of oxygen being     delivered to the tissues. It normally affects the hands and feet and can be very     debilitating. It is particularly common and difficult to treat in patients with end stage     renal failure      Patients with renal failure are often high risk of any operative intervention which might     help the pain. Often the only treatment options are painkillers. Unfortunately however, the     commonly used painkillers, for example morphine, are known to cause worse side effects in     patients with renal failure (drowsiness, confusion etc.      Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied     to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.     It therefore should not have the systemic side effects of other drugs. It has been     demonstrated to be beneficial in other painful conditions for example post-shingles pain and     nerve pain from HIV. It has never been used for critical ischaemia before.      We propose to investigate the efficacy of Qutenza in treating patients with end stage renal     failure and painful ischaemia. We will recruit 20 patients with painful ischaemia and treat     them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain     scores.   "
120831|NCT01704326|"     This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee     System and is intended to evaluate the safety and effectiveness of the new device.   "
120832|NCT01704313|"     Patients with end-stage renal failure require dialysis to remove toxins from their blood.     Haemodialysis is best provided through a native arterio-venous fistula (AVF). Creation of an     AVF requires a short (~1hr) surgical procedure to join the artery and vein together.      There are limited potential sites for fistula creation. Generally it is preferrable to     utilise the most distal sites at the wrist first, as more proximal elbow procedures preclude     subsequent use of the wrist should the initial fistula fail. The small diameter of artery and     vein at the wrist requires precise surgical technique.      There are two potential techniques in common use for creating the arterio-venous anastomosis     (the join between artery and vein) - continuous suturing and interrupted sutures. Whilst     there are theoretical advantages to the interrupted technique, it is uncertain if these     translate clinically into better success of creating the fistula. The aim of this study is     therefore to compare the clinical success of the two techniques.   "
120833|NCT01704300|"     The association between obesity and cardiovascular disease (CVD) has mostly been studied     using broad endpoints or have focused on cause-specific mortality. The investigators aim to     compare the effect of body mass index (BMI) on different types of initial presentation of     CVD.   "
120869|NCT01703832|"     The purpose of this study is to explore the efficacy of acutely dosed Neurexan using an     experimental stress test called the Trier Social Stress Test   "
120870|NCT01703819|"     The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an     experimental stress test called the Trier Social Stress Test   "
120834|NCT01704287|"     This study is being done to compare survival using pembrolizumab (SCH 900475, MK-3475) or     standard chemotherapy for participants with advanced melanoma (MEL) who have progressed after     prior therapy. Participants were initially randomized to receive either low dose     pembrolizumab, higher dose pembrolizumab or Investigator-choice chemotherapy (ICC). The     randomization to either pembrolizumab or Investigator choice chemotherapy was conducted in an     open-label fashion.      The pembrolizumab dose was initially blinded to Investigators and participants until     Amendment 03. With Amendment 03, all ongoing pembrolizumab participants will be treated with     open-label, fixed dose pembrolizumab 200 mg every 3 weeks (Q3W), instead of weight-based     dosing of pembrolizumab.      The four standard chemotherapy choices were carboplatin + paclitaxel, paclitaxel alone,     dacarbazine, or temozolomide. Participants on standard chemotherapy who experienced disease     progression may have been eligible to crossover to treatment with pembrolizumab provided they     met protocol-specified requirements for crossover. With Amendment 03, all crossover     participants will be treated with open-label, fixed dose pembrolizumab 200 mg Q3W instead of     weight-based dosing of pembrolizumab.   "
120835|NCT01704274|"     Prostate cancer is the most commonly diagnosed cancer in men in Canada. Over 30% of men over     the age of fifty have histological evidence of prostate cancer on biopsy. Despite the stage     migration afforded by early detection with serum prostate specific antigen (PSA) testing and     an apparent trend toward improved survival over the past several years, prostate cancer     remains a significant cause of morbidity and mortality. Biochemical failure after primary     therapy (surgery or radiation) remains a significant health care burden and strategies to     delay clinical prostate cancer progression and prolong the interval from treatment failure to     systemic therapy would be of significant clinical benefit for those men suffering from a     finding of PSA recurrence.      PSA is widely accepted as the most useful prognostic marker of prostate cancer progression,     particularly after primary therapy with radical surgery or radiation. 5 Despite improved     cancer control rates with definitive management of early stage prostate cancer, a PSA     recurrence is unfortunately a common occurrence (25-50%) in most large case series.      Microenvironmental factors have been demonstrated to play a pivotal role in the selection of     neoplastic cell subpopulations expressing more malignant phenotypes and contributing to the     progression of localized and metastatic disease. Very low levels of O2 (< 10 mmHg) has been     well described in many solid tumours (including prostate cancer) and the extent of hypoxia     has been demonstrated to represent an independent marker of a poor prognosis for patients     with various types of cancers. Tumour hypoxia contributes to numerous adaptive phenotypes     including increased invasion and metastasis, as well as evasion of immune cell surveillance     increased resistance to radiotherapy and chemotherapy. Although cellular adaptive responses     to hypoxia are likely mediated by various mechanisms, our previous preclinical studies     suggest that decreased nitric oxide (NO)-dependent signalling plays a significant role in     this progression of a malignant phenotype.   "
120836|NCT01704261|"     This study will examine the safety and efficacy of the addition of omarigliptin in     participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and     glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with     omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition     of placebo.   "
120837|NCT01704248|"     To investigate if the Eye Drop Guide more effective than carefully instructed routine     technique for chronic glaucoma patients to self-instill eye drops.      And what factors are associated with the failure of self-instillation eye drops with the Eye     Drop Guide?   "
120839|NCT01704222|"     Direct DNA amplification, viral isolation and specific antibody measurement in saliva from     children attending nursery in France Sample collection will be done by the pediatrician the     nurse, or one of the authorized investigators of the study.   "
120842|NCT01704183|"     The purpose of this study is to study the effect of fingolimod on cardiac autonomic     regulation in patients with relapse-remitting multiple sclerosis.      This will be done by measuring heart rate variability from the 24-hour Holter recording and     myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.      The fingolimod treatment is prescribed according to the accepted drug label.   "
120843|NCT01704170|"     This study is a prospective, multi-center trial wherein each included subject will receive     the experimental externally focused ultrasound renal denervation therapy. It will be     conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and     have signed the informed consent form. Safety is the primary endpoint of this study and will     be assessed by incidence and evaluation of any serious adverse effects associated with the     investigational procedure through the 52-week evaluation. Clinical utility is the secondary     endpoint of this study and will be evaluated by assessing pre and post therapy systolic and     diastolic blood pressure.   "
120844|NCT01704157|"     A proof of concept study to evaluate the feasibility of safe and effective treatment through     optimization of the Cryo-Touch III device for temporary relief of pain.   "
120845|NCT01704144|"     Efavirenz is an essential component of HIV treatment in children aged 3 years or older on     anti-tuberculosis (anti-TB) treatment. However, the appropriate efavirenz dose during anti-TB     treatment remains unclear. Rifampin (an anti-TB drug) increases the activity of the drug     metabolizing enzymes that breakdown efavirenz, which may lead to low blood levels of     efavirenz and treatment failure during cotreatment. The drug-to-drug interactions between the     HIV and anti-TB drugs also vary between individuals based on genetic factors. This study will     investigate the effects of anti-TB treatment, as well as drug-gene interactions on the blood     concentrations of efavirenz in children with HIV and TB infections. Such data could enhance     optimization of efavirenz dosage or selection of alternate regimens in some children.   "
120846|NCT01704131|"     Levosimendan is a drug used in patients with heart failure and has several advantages over     other heart failure drugs. A lot of research has been done with Levosimendan in Adults, and     the way the body handles the drug (pharmacokinetics) and responds to the drug     (pharmacodynamics) are well established. But, in children this information is lacking despite     the fact that Levosimendan is increasingly used in children of all ages. The investigators     aim to describe which Levosimendan dose leads to which drug levels in children of different     ages.   "
120847|NCT01704118|"     Objective of this prospective, randomized and controlled study is to compare the performances     of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with     prospective studies. In this study, primer endpoint was value of airway leak pressure and     secondary insertion time, insertion success and conditions, initial airway quality,     hemodynamic parameters, fiberoptic view and complications will be assessed.   "
120848|NCT01704105|"     The purpose of this study is to measure the independent and combined effects of interventions     that improve sanitation, water quality, handwashing, and nutrition on child health and     development in the first years of life.   "
120851|NCT01704066|"     The original American-European Consensus Conference (AECC) definition of Acute Respiratory     Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on     frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR     using this definition among intensivists and radiologists.      As a result, the newly published Berlin definition of ARDS specified that the CXR criterion     should include bilateral opacities consistent with pulmonary edema not fully explained by     effusions, lobar/lung collapse, or nodules/masses on CXR.      In order to improve inter-observer agreement, the panel have also developed a set of CXRs     judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.      The objective of this study is to investigate the impact of this training set on     inter-observer reliability in applying the radiographic definition for ARDS.   "
120852|NCT01704053|"     The purpose of this study is determine whether point of care coagulation testing is able to     map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used     as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer     (Multiplate).   "
120853|NCT01704040|"     The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part     2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before     and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).   "
120854|NCT01704027|"     The purpose of this study is to evaluate the incidence of urinary and rectal acute side     effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated     boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk     localized prostate cancer   "
120855|NCT01704014|"     Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during     cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator     muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS.     However the prevalence of IFIS in Korean population is not reported. The purpose of this     study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris     anatomical change in Korean patients taking α1-ARA.   "
120856|NCT01704001|"     To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in     patients with Disseminated Intravascular Coagulation.      To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.   "
120857|NCT01703988|"     This study will test the safety, tolerability, and pharmacokinetics of escalating doses of     nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over     the duration of the trial, in participants with spinal muscular atrophy (SMA).      Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort     of approximately 8 participants, where all participants will receive active drug.   "
120858|NCT01703975|"     Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of     medical health care providers. However, training costs are considerable and may be optimized     using interventions to improve learning. The aim of this study is to compare the effects of     training in pairs versus training alone on an VR ultrasound simulator.      Methods: 30 medical students in their final year are randomized to either training in pairs     or training alone. All participants are trained for two hours. Subsequently, all students are     assessed on ultrasound performance on real patients in an ambulatory setting. Performance is     assessed using a rating scale that has been validated in a previous study by two blinded     assessors.   "
120859|NCT01703962|"     The recurrent mutation IDH1Arg132His leads to the cellular accumulation of     D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost     specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.      The main objective is to identify the patients with IDH1 mutated glioma by three     complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA),     biochemical (2-HG dosage in the urine of patients) and radiological (2-HG   "
120860|NCT01703949|"     This pilot clinical trial studies brentuximab vedotin in treating patients with CD30+     lymphoma has come base after a period of improvement or does not respond to treatment.     Biological therapies, such as brentuximab vedotin, may stimulate the immune system in     different ways and stop cancer cells from growing.   "
120861|NCT01703936|"     This project is an evaluation of an agricultural training and resettlement program for     high-risk young adults in Liberia, especially poorly integrated male ex-combatants. The     primary aim is to see to what extent an intensive economic and life skills intervention can     rehabilitate high-risk individuals and reduce aggression and armed violence.   "
120862|NCT01703923|"     The purpose of this study is to determine the antitussive effect size and dose response of     FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability     of FP01 lozenges in subjects with chronic cough.   "
120863|NCT01703910|"     The purpose of this study is to assess the feasibility of selecting personalized therapies     for colon cancer patients who have failed standard treatments, using a new methodology based     on the determination of a profile of chemosensitivity by comprehensive genetic expression     analysis from tumor samples.   "
120864|NCT01703897|"     The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in     obese patients before and during anesthesia.   "
120865|NCT01703884|"     The program's overall objective is to assess the impact of a package of interventions aimed     at reducing malaria-related mortality and morbidity in pregnant women and newborns by     ensuring access to a package of interventions designed to optimise the detection and     treatment of malaria during pregnancy as well as improving the early detection and treatment     of malaria during the third trimester.   "
120866|NCT01703871|"     Office Hysteroscopy is associated with a level of anxiety that could condition tolerability     of the procedure by the patient.      The aim of this study is to evaluate the impact of music on anxiety state, expected and     received pain by patients during office hysteroscopy.   "
120867|NCT01703858|"     The objective of the trial is to investigate the relative bioavailability, influence of     pantoprazole coadministration and food effect of different oral formulations of BI 113608 in     healthy male subjects   "
120868|NCT01703845|"     The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol     fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3     weeks once daily treatment in Japanese patients with COPD.   "
120871|NCT01703806|"     The timing of surgical intervention in asymptomatic patients with severe degenerative mitral     regurgitation (MR) remains controversial. The benefit of early surgery has been suggested in     prospective, observational studies, whereas a watchful waiting strategy seemed to be safe and     effective in the other prospective study. The consensus guidelines for the performance of     early surgery in asymptomatic patients with severe MR are different, reflecting controversy.     Clinical outcome in asymptomatic patients with MR is poorly defined and it is important to     identify high-risk patients in whom early surgery may be warranted. Thus, the investigators     try to compare long-term outcomes of early surgery with those of a conventional-treatment     strategy in a large prospective cohort of asymptomatic patients with severe degenerative MR     using a propensity analysis, and to identify high-risk subgroups to whom early surgery is     more beneficial.   "
120872|NCT01703793|"     The purpose of this study is to determine if two test products are safe and effective in the     treatment of seborrheic dermatitis.   "
120883|NCT01703650|"     The purpose of this study is        1. to determine whether the perfusion parameters in the normal pancreas and the pancreas          cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT        2. to determine whether initial perfusion parameters as well as perfusion parameter change          in pancreas adenocarcinoma before and after chemotherapy are different between          chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD,          PD according to RECIST 1.1).   "
120884|NCT01703637|"     The purpose of this study is to explore the differences in efficacy and safety of     sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating     type 2 diabetes mellitus.   "
120917|NCT01703208|"     The purpose of this study is to evaluate the cardiovascular (CV) safety profile of     omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is     that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo     and active comparators across the omarigliptin program with regard to the risk of developing     a confirmed event in the primary CV composite endpoint.   "
120918|NCT01703195|"     The goal of this clinical research study is to learn if a type of MRI scan called diffusion     weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to     learn if DWI can predict how tumors will respond to radiation therapy.   "
120873|NCT01703780|"     Hypertension is still one of the major preventable risk factor for cardiovascular as well as     cerebrovascular diseases globally, including ischaemic heart disease, heart failure, and     renal impairment. Despite knowledge on hypertension and the availability of effective     antihypertensive medications have progressed dramatically in recent years, the rate of     uncontrolled hypertension ( reached 90%) remains high in China[1]. Among those with     uncontrolled hypertension，it has been reported that 8.9% in all individuals with     hypertension, and 12.8% in the hypertensive drug-treated population[2] are attributed to     resistant hypertension. Resistant hypertension has been defined by AHA as high blood pressure     (BP) in spite of appropriate lifestyle interventions and treatment of three or more different     types of antihypertensive drugs at optimal dose, including at least one diuretics[3,4] or     achieving adequate BP control with optimal doses of 4 or more antihypertensive drugs.      At present, not many specifically designed prospective researches concerning resistant     hypertension are available. The prevalence of resistant hypertension is not well established     and most knowledge about resistant hypertension derives from cross-sectional analyses and     clinical trials. The patients with resistant hypertension have been expected to have server     target damage, and worse prognosis than those who are non-resistant, but not well established     either in the literature[2].      The purpose of this study is to determine the prevalence of resistant hypertension     ascertained with systemic investigation and optimal treatment with antihypertensive drugs in     community populations and clinic as well as the prognosis among patients with resistant     hypertension compared with those who are non-resistant.   "
120874|NCT01703767|"     The purpose of this study is to investigate Gulf War 1 Veteran (GW1V) patient perceptions of,     and satisfaction with, their VA primary care treatment, and physician effectiveness in     delivering improved point of service, in the Primary Care Clinics at the Veterans     Administration (VA) Salt Lake City Health Care System.   "
120875|NCT01703754|"     Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with     accessible lesions.      Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time     point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with     chemotherapy (palifosfamide) is safe and efficacious.   "
120876|NCT01703741|"     This is a multicenter extension trial in adult hypogonadal males. The purpose of this study     is to evaluate the safety of testosterone gel delivered using an applicator over an extended     period of time.   "
120877|NCT01703728|"     Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian     stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe     the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age     treated with HP-hMG.   "
120878|NCT01703715|"     Dehydration is recognised as a major issue in healthcare. Recovery after illness, extended     length of stay, pressure sores and slow tissue recovery can all be impacted by dehydration.     One of the biggest problems for many people with regard to getting a drink is easy,     independent access - if they can't reach the jug/cup without a struggle then they often will     go thirsty and potentially become dehydrated.      The purpose of this study is to investigate the impact of dehydration on outcome in patients     65 years and over. Furthermore we aim to assess the impact of providing easy, 24 hour,     independently accessible fluids on reducing dehydration as well as improving patient     experience.      We hypothesise that patients who are dehydration will take longer to recover from illness and     stay in hospital for longer periods.   "
120879|NCT01703702|"     This study is designed to determine the effectiveness of florbetapir (18F) in changing     patient management and to evaluate the association between scan status and cognitive decline.   "
120893|NCT01703520|"     The objective of this study is to investigate the potential association between finasteride     (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden,     Finland, and Norway from data in national registries. The primary hypothesis of this study is     that the previously reported increased incidence of male breast cancer among finasteride     users is explained by confounding factors.   "
120880|NCT01703689|"     Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality     indicators is not well-established.      The main objective: The main purpose of the IQUARE study was to examine the impact of two     types of audit and feedback interventions on NH quality indicators and on residents     dependence levels in a 18-month follow-up.      Study hypothesis: We hypothesised that audit and feedback associated to educational and     professional supportive interventions are more efficacy in improving NH quality indicators     than audit and feedback only.      Secondary objectives: Investigate the impact of the interventions on        1. Residents:             -  Functional decline rate             -  Drug prescriptions (quantity and quality)             -  Prevalence of adverse health outcomes (e.g., falls)        2. NHs:             -  Planning and implementation of therapeutic measures   "
120881|NCT01703676|"     This study will elucidate how the parental origin of the X-chromosome influences health     status as well as metabolic fate in Klinefelter patients. Epigenetics and     transcriptome-research will be directly linked to the metabolic and inflammatory pattern of     actual patients to improve care for them. The Klinefelter Syndrome is one of the most common     genetic disorders in men. The patients have one supernumerary X-chromosome, which is partly     active and disturbs a normal male development. Testosterone deficiency in form of primary     hypogonadism is a common feature in these men. Such a condition promotes clinically relevant     metabolic patterns related to a pro-inflammatory status and diabetes mellitus type 2 (insulin     resis-tance), cardiovascular disease as well as infertility. However, the variety of     pathologies is pro-nounced between patients and low testosterone concentrations cannot fully     explain the wide scope of pathologies in these men. Some patients become clinically obvious     during puberty and adoles-cence, some in their thirties or later and all exhibit a huge     variation in phenotype. Switching on and off of specific genes on the X-chromosome is     differential, depending on the origin either from the maternal or paternal side. Hence, an     influence on the clinical picture is hypothesised. Thus, key targets are clarification of the     parental origin of the supernumerary X chromosome and elucidation of methylation and     expression profile of pivotal X-chromosomal genes. These will be related to clinically     relevant metabolic and inflammatory patterns as well as fertility to identify individual     risks as well as treatment strategies for Klinefelter patients.   "
120882|NCT01703663|"     Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy     on sleep apnea severity among patients with recent ischemic stroke.      Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as     measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control     night.      Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with     nasal EPAP therapy compared with a control night.   "
120885|NCT01703624|"     This is an investigation of the beneficial effects, tolerability and safety of a range of     single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female     patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long     term and progressive disease of the lungs, generally caused by cigarette smoking, but other     factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in     dilating the constricted airways of such patients, with a duration of action variously     described as being between 12 and 24 hours.      This study will investigate how well tolerated and safe this medication is at a range of     doses. It will also help in the selection of a suitable dose for larger and repeat dose     studies, based on measures of lung response. It will also help to determine how often the     medication should be given; twice daily, or once daily.      Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age.     Patients will be medically assessed before participation to ensure their suitability. The     study will take place in one centre in the UK over five sessions; at each session one dose (2     puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler     device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung     function will be measured for up to 26 hours after the administration of each dose using     standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the     blood levels of GB. There will be a period of about a week between each dosing session.     Patients will be medically reviewed after the study to confirm that no untoward effects are     present.   "
120886|NCT01703611|"     A clinical trial to compare the patient outcomes from usual nutrition therapy by dietitians     in India to patient outcomes from guideline-based Medical Nutrition Therapy (MNT).   "
120887|NCT01703598|"     The purpose of this study is to determine whether performing deep brain stimulation surgery     for Parkinson's disease using intraoperative imaging and frameless stereotaxis is noninferior     to using frame-based stereotaxy and microelectrode recording.   "
120888|NCT01703585|"     This is a feasibility study to look for genetic alterations in tissue and blood samples that     may be useful in determining what treatments may be useful in the patient's cancer care.   "
120889|NCT01703572|"     This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects     with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and     expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,     biomarkers, and efficacy.   "
120890|NCT01703559|"     Night vision complaints such as glare, starburst and halo are often a result of peripheral     corneal aberrations that cause light scatter when the pupil dilates in mesopic or scotopic     conditions. Modest reductions in pupil size achieved pharmacologically may reduce the light     scatter in dim light situations.   "
120891|NCT01703546|"     The purpose of this research study is to evaluate whether combining laparoscopic adjustable     gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks     in the large curve of the stomach with stitches) to lap-band surgery alone will result in a     greater loss of excess weight over time. We anticipate that the average percent of excess     body weight loss for study subjects will exceed 29% at 12 months.   "
120892|NCT01703533|"     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the     treatment of Rett Syndrome in adolescent and adult females.   "
120948|NCT01702805|"     The objective of the TOP trial is to determine whether higher hemoglobin thresholds for     transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the     primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months     of age, using standardized assessments by Bayley.   "
120894|NCT01703507|"     This phase I trial studies the side effects and best dose of ipilimumab when given together     with whole brain radiation therapy or stereotactic radiosurgery in treating patients with     melanoma with brain metastases. Monoclonal antibodies, such as ipilimumab, can block tumor     growth in different ways. Some block the ability of the tumor to grow and spread. Others find     Tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy,     such uses high-energy x-rays and other types of radiation to kill tumor cells. Giving     radiation therapy in different ways may kill more tumor cells. Giving ipilimumab together     with whole-brain radiation therapy or stereotactic radiosurgery may kill more tumor cells.   "
120895|NCT01703494|"     There has been an alarming increase in the incidence and severity of Clostridium difficile     infection (CDI) in North America over the past decade. Relapsing infection is a common     problem in patients treated for CDI, often requiring prolonged and expensive courses of oral     vancomycin with limited alternative treatment options. This study will determine if fecal     microbiota transplantation, which involves administering fecal flora from a healthy stool     donor to a patient with relapsing CDI, is an effective and safe treatment.   "
120896|NCT01703481|"     The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the body     does to a drug), and pharmacodynamics (study of what a drug does to the body) of     JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in     adult participants with advanced or refractory solid tumors or lymphoma.   "
120897|NCT01703468|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Oxcarbazepine Suspension 600 mg under fed conditions   "
120898|NCT01703455|"     This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in     patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be     conducted with the primary aim to determine the response rate (CR+PR) according to the RECIST     criteria. Response rate according to CHOI criteria, correlation between CHOI criteria and     outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary     objectives.   "
120915|NCT01703234|"     There is no data about the effects of Renin angiotensin system blockage (RAS) on FGF23 and     ADMA levels in diabetic patients with proteinuria. The aim of this study was to find out     whether the beneficial effects of RAS blockage in diabetic proteinuria has any relation with     the alteration of ADMA and FGF-23 levels. We searched for the effects of ACE inhibitor     ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.   "
120940|NCT01702909|"     The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used     in this study will help increase tumor shrinkage.   "
120899|NCT01703442|"     A single-center prospective observational study. This study examines urine flow and     haemodynamic parameters during abdominal surgery and analyses the association to     postoperative renal function and markers and to postoperative clinical outcome.      Primary hypothesis:      • Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are     phases of temporary anuria.      Secondary hypothesis:        -  Perioperative anuric phases are directly associated to the postoperative increase of          NGAL (neutrophil gelatinase-associated lipocalin) and creatinine        -  Perioperative renal dysfunction is directly associated to postoperative complications          and functional recovery of patients        -  A response of urine flow to a standardized postoperative diuretic bolus can identify          patients who benefit from a pharmaceutical fluid mobilization        -  Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the          methods for the measurement of stroke volume of the heart differ   "
120900|NCT01703429|"     This is a prospective, observational study designed to describe disease progression, symptom     change, quality of life, diet and lifestyle habits, and frequency of adverse events among     patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM).     In addition to describing the patterns of CAM use, this study will also identify and describe     the positive deviants, those individuals with the highest quality of life and least amount of     disease activity. Positive deviants will be compared to controls in order to describe     medication, diet, and lifestyle patterns associated with a lack of MS disease progression and     high quality of life.   "
120901|NCT01703416|"     This is a multi-center, prospective, non-interventional study that aims to evaluate in daily     clinical practice the possible correlation between patient perception of the ability to     perform morning activities and the physician's assessment during a regular physical exam in     patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.   "
120902|NCT01703403|"     Low back pain is a common health issue in elderly population. According to the statistics,     more than 80% of Taiwanese suffer low back pain in the life. The cause of low back pain     includes lumbar spondylosis, osteoporosis, compression fracture, muscle strain,     spondylolisthesis…etc. In addition to drugs and surgery, physical therapy is an alternative     choice for conservative treatment. Therefore, in this study, the investigators propose to     analyze the physical examination, diagnostic methods, X ray, physical therapy records,     physical therapy methods and clinical outcomes in patients with the diagnosis including     lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at     National Taiwan University Hospital and received rehabilitation at the Physical Therapy     Center in recent ten years.   "
120903|NCT01703390|"     This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene     expression status suggests better clinical results from historical experience in metastatic     colorectal cancer (mCRC). In wild type KRAS mCRC patients treated with either FOLFOX or     FOLFIRI in combination with cetuximab the median response rate is approximately 60-65%.     Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1     treated with FOLFOX and cetuximab, and those with high ERCC-1 treated with FOLFIRI and     cetuximab, will improve response rate to 70-75%. KRAS wild type patients will be treated with     6 cycles of one of the following regimens chosen for optimization based on patient     characteristics (primary treatment phase). Patients with ERCC-1 < 1.7 relative gene     expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6 in     combination with Cetuximab. Patients with ERCC-1 gene expression > 1.7 relative gene     expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with     FOLFIRI in combination with Cetuximab.   "
120904|NCT01703377|"     A major advantage of understanding a neural control scheme is able to simultaneously perform     multiple tasks based on the Uncontrolled Manifold (UCM) hypothesis by taking advantage of     motor redundancy. The present study aims to investigate this hypothesis further by examining     the effect of artificially eliminating knee and lumbar-thoracic joint motions on postural     control when the arms performing targeting task simultaneously in standing. Subjects (Younger     group: 20~35 years old; Elder group: 60~85 years old) will execute a targeting task with and     without an additional ball-balancing task in standing with free joint motions and with     restricted joint motions. The investigators expect to recruit 50 subjects for each group.     Analyses of joint configuration variance on the stability of the center of mass (COM)     position and the hand path will be performed using the UCM method of variance analysis. This     method partitions joint configuration variance into one component consistent with the use of     motor abundance and a component that leads to COM position or hand path variability.     Furthermore, the differences between the younger group and the elder group will be evaluated.   "
120905|NCT01703364|"     This is a trial in patients with previously untreated CLL. Eligible patients will receive     Lenalidomide with a backbone of Fludarabine and Rituximab for 6 therapy cycles. Lenalidomide     will be increased by dose steps of 5 mg every cycle in the absence of limiting toxicity. If     limiting toxicity ensues the patients will be treated with last tolerable dose for the     remainder of the 6 treatment cycles.      The first 5 patients will start with dose level 5 mg Lenalidomide and further escalating     dose. After the fifth patient is included in the study, enrolment will be interrupted until     this patient has finished his first treatment cycle. A safety board will evaluate the     toxicities of the first 5 patients. If there are more than 2 patients experiencing a dose     limiting toxicity (DLT) in the first treatment cycle, the starting dose will not be escalated     and further 5 patients will be enrolled with a starting dose of 5 mg Lenalidomide. If only 2     or less patients experience a DLT in the first treatment cycle, the next 5 patients will     start the treatment with 10 mg Lenalidomide.      The rational for the higher starting doses stems from the lack of tumor lysis or tumor flare     toxicity in this combination on the one hand and from the observation that the very slow     escalation from 2,5 mg on led to a lack of efficacy in monotherapy trials due to early     progression in a relevant number of cases. The increase of the Lenalidomide dosage should     result in an increased efficacy especially at the beginning and a higher cumulative dose of     Lenalidomide.      The identification of patients intolerant to Lenalidomide by immunophenotyping of the T cells     for validation is also part of this trial, because intolerance seems to be not dose dependent     but may be caused by T cell activation. Therefore, early identification of patients     intolerant to this form of modern immunochemotherapy and establishing efficient Lenalidomide     based combination therapy is an important part of improvement of current CLL treatment.   "
120916|NCT01703221|"     The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as     monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up     to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1)     Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated     hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in     participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in     participants treated with sitagliptin 50 mg daily.   "
120941|NCT01702896|"     The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used     in this study will help to increase tumor shrinkage   "
120906|NCT01703351|"     Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy     and it has reduced the operative morbidities and mortalities. However, thoracoscopic     lobectomy also results in operative acute pain and the incidence of chronic pain after     thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar,     torque at trocar and working window by operator, and compression of intercostal nerves have     been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous     patient-controlled analgesia (IV PCA) that usually have used to control the operative pain,     sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic     delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the     effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous     paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might     reduce the side effects of IV PCA and control the operative pain effectively. In this study,     we investigate the effectiveness of continuous paravertebral infusion of local anesthetics     thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.   "
120907|NCT01703338|"     Lumbar fusion has been widely used for spinal disorders when conservative treatment has     failed. However, a number of studies have reported that the rate of re-operation is high for     lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the     surgery site can cause weakness and pain. After fusion, the range of motion is constrained at     the fused spine and might facilitate compensative movement of the adjacent levels and     increase degeneration rate of the spine.      Evidence has shown that core muscles play an important role to stabilize and support the     spine. Whether core stability exercise can enhance spinal stability after lumbar fusion     surgery remains unclear. Therefore, the overall goal of this proposed research is to     investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators     will explore this issue hierarchically and systematically in 3-year duration.   "
120908|NCT01703325|"     Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects     both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect     in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis,     discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of     psoriatic nails is using topical high- potent steroids however topical steroids are limited     their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of     such a treatment can lead to skin atrophy and report in the case of Disappearing digits.     Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory     results without any serious permanent adverse effects. At present, there is no comparison     study between intralesional steroid and ultrapotent topical steroid for the treatment of     psoriatic nails.      The purpose of the study is to evaluate the efficacy and safety of intralesional     triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.   "
120909|NCT01703312|"     This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with     allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen     that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at     12 weeks compared to baseline will be evaluated.   "
120949|NCT01702792|"     This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to     determine the ability to generate human hybridomas from lymph nodes draining an autologous     tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific     antibodies.   "
120910|NCT01703299|"     The use of carbapenems, very broad spectrum antibiotics of last resort, is becoming more     common due to the increased prevalence in the hospital and community of extended spectrum     β-lactamase (ESBL) producing gram-negative bacilli (GNB), including CTX-M type, which are     resistant to all other β-lactam antibiotics. Meanwhile, it creates a selective pressure     towards emergence of strains which are also resistant to carbapenems, placing patients in a     catastrophic situation of therapeutic dead-end. A better understanding of the mechanisms of     emergence of BGN resistant to carbapenems is necessary to optimize their use and undertake     preventive measures to preserve their effectiveness. The aim of the study is to evaluate and     describe the emergence of carbapenem-induced resistant GNB in patient intestinal microflora.   "
120911|NCT01703286|"     The general aim of the present study is to investigate the impact of 4 weeks treatment with     linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the     current trial this effect of linagliptin treatment on endothelial function will be compared     against both the sulfonylurea glimepiride and against placebo, which has not been tested in a     trial before; as also is the case for other DPP-4 inhibitors.      Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second     most used oral antidiabetic drug class.   "
120912|NCT01703273|"     While adolescents with obesity and extreme obesity are at increased risk for health     complications, especially adolescents with extreme obesity rarely seek medical care, and     sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the lack     of adequate treatment options.      In this multicenter study, we aim to test a new, low key group intervention focusing on     improving compliance and psychosocial functioning. The study is a subproject of the Medical     and psychosocial implications of adolescent extreme obesity - acceptance and effects of     structured care, short: Youth with Extreme obesity Study (YES), which aims at improving the     medical care and social support structures for youth with obesity and extreme obesity in     Germany.      Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially     up to 21 years) are eligible to participate. Participants will be asked to complete a series     of questionnaires on their general health, psychosocial situation and wellbeing, and will be     offered a thorough medical evaluation. Individuals who complete the baseline evaluations will     be invited to participate in 6 group sessions over a 3 months period. Group assignment to the     psycho-social intervention vs. routine care group will be at random, like throwing a dice.     After 6 months, participants will complete further questionnaires to evaluate the effects of     the interventions on quality of life and psycho-social functionning.      The study will show the acceptance and effectiveness of a new intervention focusing on     improving compliance and psychosocial functioning in adolescents with extreme obesity, and     thereby inform the development of new treatment and support options for these adolescents. If     interested, participants are invited to participate in additional components of YES, and to     receive medical care and psycho-social support.   "
120913|NCT01703260|"     The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy     on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.   "
120914|NCT01703247|"     The investigators have conducted a prospective, double-blind, randomized study to assess the     comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions     (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF.     Results were assessed after follow-up of at least 3 years with the use of an implanted     monitoring device (IMD).   "
120942|NCT01702883|"     The purpose of this study is to evaluate whether participation in an Internet-based     intervention helps improve medication use.   "
120943|NCT01702870|"     A prospective observational study to determine the effectiveness of magnetic resonance (MR)     imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.   "
120919|NCT01703182|"     TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations.     Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30     minutes before their surgery and will be followed up until 6 months after their surgery. The     purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide     measurements in the legs of patients undergoing lower limb amputation to predict wound     healing complications and to determine an optimum cutoff value for both oxygen and carbon     dioxide levels beyond which healing complications are likely to occur and a closer amputation     level is indicated.   "
120920|NCT01703169|"     The investigators hypothesis is that eltrombopag given to patients with moderate to very     severe aplastic anemia will result in an increase in platelet counts. The investigators     hypothesize that in patients with moderate to very severe aplastic anemia, treatment with     eltrombopag will lead to fewer platelet transfusions, red blood cell transfusions, and fewer     bleeding events. The investigators hypothesize that in patients with moderate to very severe     aplastic anemia, eltrombopag will have an acceptable toxicity rate <3%, at doses that result     in increased platelet counts. Finally the investigators hypothesize that plasma eltrombopag     levels in peripheral blood will correlate with improved platelet counts.   "
120921|NCT01703156|"     A large number of patients are diagnosed with low risk ACS, and these individuals are at     significant cardiovascular risk. Though guidelines recommend stress testing to manage low     risk ACS patients, evidence supporting this recommendation is not based on trials examining     this population. A well-designed, randomized trial is warranted to determine if stress     testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the     investigators hypothesize, healthcare expenditures could be reduced and patients may not be     exposed to the harms associated with more invasive cardiac testing such as coronary     angiography.   "
120922|NCT01703143|"     To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with     focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and     safe minimally invasive technique for control of seizures in such patients.   "
120923|NCT01703130|"     Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder     surgery. However, patients can experience complications such as blurred vision, hoarseness     and shortness of breath with the standard volumes of local anesthetic used in contemporary     practice. Patients with respiratory diseases are precluded because of the potential effects     on respiration. However, they are then exposed to the risks of general anesthesia and opioid     medications which can also have detrimental effects on respiration. Ultrasound guided ISB can     reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this     may reduce the complications from ISB to allow patients previously unable to benefit to have     this technique, such as patients with obesity and respiratory disease. In order to do so the     investigators will use an up-down methodology to find the minimum volume of local anesthetic     to provide sufficient anesthesia for shoulder surgery.   "
120950|NCT01702779|"     This is a prospective, randomized clinical multicentric study in ICU (Intensive Care     University)during weaning from mechanical ventilation.   "
120924|NCT01703117|"     Cognitive aging is a major source of disability in an increasingly aging population. The     paucity of effective treatments for cognitive aging disorders, and most importantly in     Alzheimer's disease instigates a need for further research into novel therapeutic     possibilities. Alzheimer's disease is the most common neurodegenerative disorder and its     prevalence steeply increases. Glutamate-mediated excitotoxicity in neuropsychiatric disorders     and in particular in Alzheimer's disease has been shown to cause significant cerebral damage.     Early effective therapeutic intervention in Alzheimer's disease is critical in order to     prevent or at least retard neuropathological progression that will lead to widespread     irreversible neuronal loss and significant cognitive dysfunction. Riluzole, a glutamate     modulator agent that is a proven safe medication and has not yet been used in cognitive aging     disorders, will be tested in mild Alzheimer's disease patients. Cognitive functional changes     along with two established in vivo biomarkers, namely, Magnetic Resonance Spectroscopy (MRS)     and Fluorodeoxyglucose (18F) positron emission tomography (FDG-PET) will be evaluated.   "
120925|NCT01703104|"     The primary objective is to determine if there is a significant increase in the haematocrit     value of patients on Jobelyn and standard therapy compared to those on standard therapy     alone.   "
120926|NCT01703091|"     The purpose of this study is to evaluate the effects of ramucirumab in combination with     docetaxel in participants with Stage IV non-small cell lung cancer who have had disease     progression during or after one prior first-line platinum-based chemotherapy with or without     maintenance therapy for advanced/metastatic disease.   "
120927|NCT01703078|"     The purpose of this study is to determine if the new ingenol derivative gels are as safe as     and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for     two consecutive days.   "
120928|NCT01703065|"     This pilot clinical trial studies cabozantinib in treating men with castration-resistant     prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth.   "
120929|NCT01703052|"     This study is designed to investigate the safety, tolerability and pharmacokinetics of     inhaled CHF 6001 after single and multiple doses in healthy volunteers.   "
120930|NCT01703039|"     The investigators are doing a research study to find out if riluzole, when taken along with a     standard antidepressant (sertraline) can help people with major depression.      This research study will compare riluzole + sertraline to placebo + sertraline. The     investigators hypothesize that adding riluzole will lead to a better antidepressant response,     in less time, then sertraline alone.   "
120931|NCT01703026|"     Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to     detect pancreatic cancer at an earlier stage, to improve current method of T staging and     assessment of surgical resectability and also to distinguish between benign and malignant     pancreatic masses. All these will translate into better clinical outcome, and also avoid     unnecessary surgery in situations of unresectable cancers.   "
120954|NCT01702727|"     The study aims to determine whether 30 minutes of treatment playing an interactive computer     game weekly for 6 weeks, improves visual acuity. The game has been specially configured to     ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses     which manipulate the image seen by each eye in order to provide more information to the     amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM     technology, play the computer game but without the I-BiTTM technology, or watch a DVD using     the I-BiTTM technology.   "
120932|NCT01703013|"     The pathophysiology of the adrenal insufficiency of patients with critical diseases remains     unclear. In a prior exploratory study investigating patients with exacerbation of chronic     obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant     correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the     adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to     demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level     (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in     inflammatory lung diseases (patients with COPD and pneumonia).   "
120933|NCT01703000|"     NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting     Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of     Atherosclerotic Lesion(s)   "
120934|NCT01702987|"     It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function     and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment     of PCr recovery kinetics in patients using statins. The investigators propose a pilot study     to extend our research to examine PCr recovery kinetics in 20 statin users randomized in a     parallel arm study to either ubiquinol or placebo over 4 weeks.   "
120935|NCT01702974|"     The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to     treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms     and decreased inflammation.   "
120936|NCT01702961|"     High-dose chemotherapy followed by autologous (the patient's own) peripheral blood     (circulating blood) stem cell (cells that divide to form white cells, red cells and cells     that help clot) transplantation is a conventional treatment for patients with lymphoma     (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse     (recurrence of disease). For patients who did not have a complete response after traditional     chemotherapy, the chance is high that the tumor will return even after high-dose     chemotherapy. To improve the response and decrease the chance of relapse, doctors have used     rituximab, an antibody that kills lymphoma cells, both before and after transplantation.     These doctors have reported that more patients had control of the tumor for an extended     period of time using rituximab with high-dose chemotherapy with autologous stem cell     transplantation. How widely this is applicable is not known.      The purpose of this clinical research trial is to confirm that there is a good control of     tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional     stem cell transplantation.   "
120959|NCT01702662|"     Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in     chemotherapy/radiotherapy oral mucositis.      Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule     treatment in mice showed a significant beneficial effect on the endoscopic severity of     DSS-induced colitis in mice.      Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill     treatment in healthy volunteers.   "
120937|NCT01702948|"     Background:      - Nicotine addiction often makes it difficult to stop smoking. Researchers want to understand     the areas of the brain that are important in nicotine addiction. They will use a type of     brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to look at part     of the brain that may be involved in nicotine addiction. They will see how these areas affect     brain function, thinking, and decision making. For this study, rTMS will first be tested on     nonsmokers, then smokers will be recruited at a later time.      Objectives:      - To study areas of the brain involved in nicotine addiction.      Eligibility:      - Individuals at least 18 years of age who do not smoke.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          provide a urine sample.        -  There will be four study sessions. The first session will involve a magnetic resonance          imaging (MRI) scan. The other three visits will involve rTMS and MRI scans.        -  The first MRI scan will take a baseline picture of the brain. Participants will also          practice the tasks for the other three sessions in a mock scanner.        -  At the next three visits, participants will have rTMS and MRI scans. Two visits will          involve rTMS; the other visit will involve mock rTMS with no actual magnetic          stimulation. During the MRI scans, participants will perform tasks that involve decision          making.   "
120938|NCT01702935|"     Background:      - Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means     that the ovaries are not able to function at a level appropriate for a woman's age.     Previously, it was thought that women had only a fixed number of eggs that were lost each     month until none were left at menopause. However, recently, stem cells have been found in the     ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells     may help women with POI in the future. Researchers want to collect ovarian tissue from women     with POI to investigate ovarian stem cells.      Objectives:      - To collect ovarian tissue from women with primary ovarian insufficiency.      Eligibility:      - Women between 18 and 50 years of age with primary ovarian insufficiency.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have a full gynecological exam. They will provide blood and urine samples.        -  Participants will donate ovarian tissue for study. It will be collected through          outpatient surgery. The surgery will take either half of an ovary or a full ovary.        -  Treatment will not be provided as part of this study.   "
120939|NCT01702922|"     Background:      - Serious illnesses like cancer or Neurofibromatosis Type 1 (NF1), can cause high levels of     stress in a family. When a child is diagnosed with cancer or NF1, parents face numerous     stressors, each of which can strain relationships. Many parents struggle to effectively cope     with the changes in parenting roles that often accompany treatment of childhood cancer or     NF1. How parents cope with this stress can influence whether the relationship is strengthened     or weakened. Stress levels can also affect the care of the child who has cancer or NF1.     Researchers want to better understand the critical time points and events during the child s     treatment when the relationship becomes most stressed and/or strengthened.      Objectives:      - To study how stress affects the relationship between parents who have a child with cancer     or Neurofibromatosis Type 1 (NF1).      Eligibility:        -  Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer or          NF1.        -  Participants must have been in a partnership at the time the child was diagnosed with          cancer or NF1. At least one of the parents must be a biological or legal parent of the          child.      Design:        -  Participants will fill out a questionnaire either online or by paper and pencil. It will          take about 20 minutes to complete. The questions ask about the experience of dealing          with a child s cancer OR NF1 diagnosis and how it affects participants relationship with          their spouse/partner.        -  Some participants will also have an in-depth interview. It will last about an hour. It          will ask further questions about the cancer OR NF1 diagnosis and treatment and its          effect on the relationship.        -  Treatment will not be provided as part of this study.   "
120944|NCT01702857|"     This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV     vaccine in a predominantly dengue-primed adult population. The study is designed to afford a     first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine     candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or     AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate     vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of     purified virus antigen per each of the four DENV types. Additionally, the study will evaluate     an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per     each of the four DENV types. The control group will receive a saline placebo. All     experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart.     There is a parallel FTiH study that is conducted in the United States in a dengue-naive     population using the same investigational vaccines.   "
120945|NCT01702844|"     The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for     a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell     lung cancer (NSCLC)   "
120946|NCT01702831|"     A number of strategies have been proposed to improve the outcome of ASCT. The three main     strategies are to incorporate novel agents into the induction regimen, using maintenance     therapy following ASCT and the final strategy is to enhance conditioning regimens.      Investigators would like to explore all these three strategies in this study: Investigators     propose to take patients who have had standard novel agent (bortezomib) based induction     regimens into this study and then use a dose-adjusted combination of busulfan and melphalan     as conditioning regimen and finally Investigators would like to incorporate lenalidomide     maintenance post ASCT until disease progression.   "
120947|NCT01702818|"     Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone     activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although     DHEA is a precursor of testosterone it has other actions including involvement in the stress     system. It is also linked to mood. This study focuses on measures of childhood stress,     current mood and salivary and nail stress hormones, in women with and without HSDD. We     hypothesize that low levels of DHEA reflect dysfunction of the neuroendocrine stress response     system involving the brain, pituitary and adrenal glands where DHEA is produced.   "
120951|NCT01702766|"     Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common     nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be     defined as infections which develop more than 48 hours after admission and they are not     present or incubating on admission      This study is a prospective, randomized, double blind, placebo- controlled parallel study in     children hospitalized at Children's hospital Zagreb.      The study will investigate the effect of supplementation with the probiotic strain     Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and     respiratory infections.      The test product is a sachet containing 1 gram of powder. The test product will contain     minimum 1 billion CFU (colony forming units) probiotic per serving.      The placebo product is an identical product except for the absence of probiotics.      The study includes an intervention period lasting the length of the hospital stay.      The study product will be consumed daily in the morning together with breakfast.      The consumption of the study products will be taken under the surveillance of the physician.      Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of     infections will be analyzed based on the information recorded in the CRF.   "
120952|NCT01702753|"     Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common     infections (gastrointestinal and respiratory) in healthy children who attend day care centre      This study is a prospective, randomized, double blind, placebo- controlled parallel study in     healthy children attending day care centers.      The study will investigate the effect of supplementation with the probiotic strain     Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and     respiratory infections and absence from day care due to infections.      The test product is a sachet containing 1 gram of powder. The test product will contain     minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is     an identical product except for the absence of probiotics.      The study includes 3 months (90 days) of intervention period. The study product will be     consumed daily in the evening together with a meal.      The consumption of the study products will be taken under the surveillance of the parents.      During the entire intervention period the subjects are not allowed to consume any probiotic     products other than the study products supplied to them by the study personnel.      Data on infections will be recorded in a diary, filled in and administered by the parents and     diary recorded by referring physician (on-call log).      All infections are to be diagnosed by the local physician. The incidence of infections will     be analyzed based on the information recorded in the diaries (parent's & physician's).   "
120953|NCT01702740|"     The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the     action of a drug in the body over a period of time) of multiple intravenous (IV)     administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic     lupus erythematosus (SLE). The secondary goal of this study was to assess the     pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of     action), immune response, and clinical response.   "
120990|NCT01702259|"     The purpose of this study is to determine whether the application of green diode low level     laser light therapy is effective in reducing the appearance of cellulite in the thighs and     buttocks.   "
120955|NCT01702714|"     This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an     expansion cohort will determine the recommended Phase II dose and schedule to investigate     safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine     or carboplatin and paclitaxel in patients with advanced or recurrent non-small cell lung     cancer of squamous histology who have not received prior chemotherapy for the metastatic     disease. Cohorts of patients will receive escalating doses of RO5083945 in combination with     up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time     on study treatment is until disease progression or unacceptable toxicity occurs.   "
120956|NCT01702701|"     This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs     standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective     in treating symptoms and histology of EoE when compared to fluticasone. The study will be     conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After     identification and recruitment all patients will be randomized (provider blinded) to one of     two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also     complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then     undergo a repeat endoscopy to evaluate endoscopic and histologic response.   "
120957|NCT01702688|"     Thank you for your interest in our Blood Pressure Research Study. The American Heart     Association is sponsoring us to investigate why patients develop high blood pressure,     atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our     research program. The first part is a screening visit. At this visit you will be given a     brief physical exam and will be asked questions concerning your medical history. During the     same visit you will have your blood drawn for routine screening and genetic testing. You will     also be asked to collect a urine sample for routine screening.      If the doctor finds that you are a healthy candidate you will be invited to participate in     the second part of the study. During Phase II, we will perform physiological tests after you     are placed on a low salt diet and again after you are placed on a higher salt diet. If you     are on blood pressure medication, it may be necessary to discontinue taking your present     medication for up to three months before beginning the study. Patients discontinuing their     current blood pressure medication may be placed on a different blood pressure medication     during this 'washout' period if necessary to maintain blood pressure at pre-study levels.      Once your blood pressure medications are discontinued, you will be closely monitored. If you     do not own a home blood pressure monitor, we will provide one for you to use during the study     so that you can keep a daily record of your blood pressure readings. We will ask you to call     us every three days to report your blood pressure readings. After you have stopped taking     your medication, dietitians at the hospital will make you low salt meals to eat at home for     about seven days. On the last day of the low salt diet, you will be asked to begin a 24-hour     urine collection that you will bring with you when you are admitted to the hospital that     evening. That morning, you will be required to come to the Center for Clinical Investigations     (CCI) at Brigham and Women's Hospital for a one-hour test to check if your body is in the     correct salt balance.      You will return that evening to the CCI where you will be admitted for your study that will     occur the next morning. On the morning of your low salt study, we will collect some blood     samples. We will also take ultrasound pictures of your heart to see how salt and hormones     affect the way your heart and blood vessels functions. These tests will last approximately 5     hours and you will be discharged around 2:00 PM. For the next 5-7 days, you will be placed on     a liberal salt diet. During this diet period, you will eat all your own food, but we will     give you some supplements to add to your meals. After 5-7 days on your liberal salt diet, on     the morning of your second admission to the hospital, you will be asked to begin a final     24-hour urine collection. That morning, you will again be required to come to the CCI for a     blood test, and you will return later that evening to the inpatient CCI where you will be     admitted for your final overnight study. The same study that was done for the low salt diet     will be repeated for the liberal salt study. You will be discharged at around 2:00 p.m. These     studies will help to determine if you are salt-sensitive. In addition, we hope to learn more     about the hormones that regulate your blood pressure and the genes responsible for regulating     those hormones.      You will be placed back on your initial blood pressure medication (if you are on any) and     returned to your regular physician for care. We can also provide clinically relevant     information to you.   "
120958|NCT01702675|"     The purpose of this study is evaluate the safety and tolerability parameters regarding the     new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and     multiple doses of the new drug.   "
120963|NCT01702610|"     Patients with GBM, who were deemed ineligible for any active protocols at our centre,     received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with     conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty     five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated     with a median KPS of 90 (range 50-100). Four patients had multicentric disease at     presentation. Eight patients had biopsy only while the rest had a near total resection (n=14)     and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was     14.4 months.   "
120964|NCT01702597|"     The aim of this bicentric, biphasic, randomized, controlled study is to compare of the     current gold standard functional treatment to functional treatment plus WBV in patients with     acute unilateral unstable inversion ankle sprains over a period of 12 months   "
120965|NCT01702584|"     Prospective registry study to evaluate safety and efficacy of stent assisted embolization of     intracranial aneurysm.   "
120966|NCT01702571|"     This two-cohort, open-label, multicenter study will assess the safety, efficacy and     tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced     breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and     chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general     participant population; Cohort 2 will include only Asian participants.   "
120967|NCT01702558|"     This multicenter study will assess the maximum tolerated dose of capecitabine in combination     with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive     LA/mGC using a Phase I design, followed by a randomized, open-label Phase II study to explore     the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla     alone in mBC. The anticipated time on study treatment is until disease progression,     intolerable toxicity, or withdrawal of consent.   "
120991|NCT01702246|"     The purpose of this study is to determine whether simvastatin is effective in reducing the     frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.   "
120968|NCT01702545|"     The current state of knowledge on the concentration of drugs and their metabolites in the     individual human body is not satisfying concerning the question about behavior of drugs in     the human body, taking into account individual patient factors such as age, weight and organ     dysfunctions.      This projects deals with the question of drug levels in the blood of hospitalized patients.      The aim of this study is to extend the knowledge about the behavior of drugs in the human     body significantly, for the safety and benefit of future patients. This also includes to     establish a relationship between drug levels in patients and the desired and undesired     effects of a drug.      As a result, the future perspective is to find the optimal dose for the individual patient by     measuring the blood concentration of a drug.   "
120969|NCT01702532|"     Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this     study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint     nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model.     The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and     the manipulations required to light a cigarette. The smokers will be denied access to     cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine     withdrawal and an increase level of cigarette craving.   "
120970|NCT01702519|"     Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an     alternative supplier delivers the same nicotine blood profile as that of the currently     approved NTS with a polyisobutylene adhesive from the current supplier.   "
120971|NCT01702506|"     Evaluation of the potential effect that the administration of food or antacid medication may     have in the oral absorption of dacomitinib relative to the administration of dacomitinib in     absence of food or antacid medication   "
120972|NCT01702493|"     This is an open-label, randomized, controlled, single center study to assess the safety,     variability in exposure, and relative bioavailability of new oral formulations of SRT2104.     This is a two part study and each part consists of screening (within 21 days of the first     scheduled dose of SRT2104), treatment period and follow-up visit (approximately 6 days after     the last dose). Part 1: Subjects will receive all four fomulations of SRT2104 and their order     of their doses will be randomized. Each subject will receive one formulation as a 500     milligram (mg) dose (in the form of two 250 mg capsules or tablets) in each session given in     the fasted state. Each dose will be separated by at least 6 days. Pharmacokinetic (PK)     sampling will be done pre and post each scheduled dosing session. After all 4 dosing     sessions, the safety and PK data will be reviewed to determine which, if any, formulation(s)     will be carried forward into Part 2. The total duration will be approximately 7 weeks. Part     2: Is further divided into Part 2A, 2B and 2C of the study and are optional. After the     completion of Part 1, the sponsor will decide whether to proceed with any or all of Part 2,     and whether the selected formulation(s) is to be administered in the fed or fasted state for     Parts 2B and 2C. For all the sub parts of Part 2 the pre and post-dose PK samples will be     obtained. Part 2A: A single-dose of the selected formulation(s) from Part 1 will be     administered after a standard meal to assess the effect of food on the bioavailability of     SRT2104 at the 500 mg dose. The total duration will be approximately 4 weeks. Part 2B: A     single alternative dose (other than 500 mg, but not to exceed 2000 mg) of the selected     formulation(s) from Part 1 will be administered to assess the safety and PK profile of this     dose level. The total duration will be approximately 4 weeks. Part 2C: The selected     formulation(s) from Part 1 will be administered at the 500 mg dose once daily for 7     consecutive days, to assess the safety and tolerability and characterize the PK profile of     repeat dosing. The total duration will be approximately 5 weeks.   "
120973|NCT01702480|"     This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK]     Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study     investigating the PK profile of four different doses of GSK2981710. Eight subjects will     receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning     and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each     period. Each subject will complete a total of four dosing sessions and 4 days of PK     assessments in 2 weeks. The Part 1 PK data will be used for dose selection and     pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive, an     additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses) to     increase confidence. A subject's total participation in Part 1 of the study will last a     maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may     be screened for eligibility and enrolled for Part 2.      Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover     design with 14-day treatment periods investigating the efficacy (cognitive performance) and     tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710 selected     from Part 1. Part 2 of the study will include the Screening period, two Baseline assessments     (6-8 days before each Treatment period) and two 14-day treatment periods separated by a     minimum 7-day washout period and follow-up visit of 3 to 5 days. Approximately 50 to 80     subjects will be randomized to either GSK2981710 or placebo. The PD assessments will be     performed on 6 occasions for each subject: at 2 baselines (6 to 8 days before Day 1 of each     treatment period), post-dose on the Day 1 of each treatment period to assess acute effects     and on Day 15 of each treatment period (which is the day after the final dose) to assess     chronic effects. A subject's total participation in Part 2 of the study will last     approximately up to 12 weeks including screening.   "
120974|NCT01702467|"     The current study will examine the safety, tolerability, plasma pharmacokinetics (PK), and     plasma pharmacodynamics (PD) of single-doses of GSK2647544.The study will be conducted as a     randomized, single-blind, placebo controlled, 4-way crossover single oral ascending dose     design in 2 independent cohorts, eight healthy male subjects in each of the cohorts. Each     potential subject will undergo Screening visit, Treatment Phase and Follow-up visit.   "
120978|NCT01702415|"     Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.      Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF);     they have an increased rate of bone fractures in comparison to the general population. CF     patients start to lose bone density in adolescence/early adulthood due to an imbalance in     bone breakdown and formation. Predicted survival for patients with CF has increased from 16     years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities     associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous     bisphophosphonates are known to increase bone density in CF; the current licensed oral     preparations require daily or weekly dosing which are difficult to maintain. Zoledronate,     which is licensed for use, is administered intravenously once a year which should be easier     to administer. The current evidence relates to its use in other disease groups e.g.     glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain     its efficacy in cystic fibrosis.   "
121056|NCT01701401|"     The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of     ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without     ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic     genotype 1 HCV infection.   "
120979|NCT01702402|"     The proposed operations research study is designed to evaluate a package of family planning     services and related behavior change interventions aimed at addressing the unmet need for     family planning in postpartum women, integrated with an ongoing maternal and newborn health     program, and to assess the program's impact (1) on knowledge of healthy fertility practices,     (2) on contraceptive use prevalence in women during the postpartum period, (3) on postpartum     birth spacing, and (4) to examine the feasibility and sustainability of the proposed     integrated service delivery approach. The study will have a quasi-experimental design, with     evaluation primarily through household surveys in four intervention unions and four     comparison unions (unions are lowest local government entities with an average population of     about 20,000) in rural Sylhet District, Bangladesh.   "
120980|NCT01702389|"     Remifentanil is a rapid-acting opioid which has been widely used in pain treatment during     surgery for the last 15 years 1. Remifentanil is rapidly eliminated (minutes) from the body     after end of infusion, and this makes it easily manageable compared to other opioids.     However, there are both experimental and clinical studies indicating that remifentanil, after     end of infusion, triggers increased pain sensation and increased opioid consumption     post-operatively. Increased post-operative opioid consumption should be avoided due to the     adverse effects of these drugs (nausea/vomiting, pruritus, dizziness, fatigue and reduced     respiratory rate). Thus, it's important to investigate relevant strategies to avoid the     increased pain sensation (opioid-induced hyperalgesia = hypersensitivity to pain stimuli)     after end of infusion of remifentanil after surgery. Several experimental and clinical trials     have been conducted in this field. Ketamine has been shown to block this effect, but its     adverse effect profile (i.a. hallucinations) makes it not suitable in normal clinical use. In     a study of healthy volunteers, it has been demonstrated that parecoxib (a COX-2 selective     NSAID) can prevent remifentanil-induced hyperalgesia. Our group has previously shown that a     relatively COX-1 selective NSAID (ketorolac) can prevent hyperalgesia in an experimental pain     model.      This is of interest since NSAIDs are frequently administered as premedication before surgery.     There are several disadvantages associated with the use of COX-2 inhibitors, e.g. the risk of     myocardial infarction after long-term use (> 1 year), and potentially reduced bone healing     after orthopedic surgery. However, this has not been shown with short-term use (days/week).     The disadvantages associated with the use of e.g. ketorolac (a COX-1 inhibitor) are i.a.     increased bleeding tendency, which is unfavourable for the surgeon, and increased risk of     gastric ulcer. Therefore, it is of interest to investigate other ways of preventing     opioid-induced hyperalgesia. In a recent animal study it has been shown that gradual dose     reduction of remifentanil (vs. abrupt withdrawal of a relatively high remifentanil dose) can     prevent the development of hyperalgesia after end of infusion. In this study we will i.a.     investigate whether this is also the case in humans. In this new model, the study     participants will get remifentanil infusion with two different dose reduction regimes:     gradual reduction or abrupt withdrawal.   "
120981|NCT01702376|"     This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover     study design in healthy male and female subjects. The study consists of screening (28 days),     treatment (1 day/dosing session) and follow-up (7 to 14 days) period and the total duration     of study participation for each subject will be approximately 9 weeks. Each subject will     participate in 4 dosing sessions separated by a minimum 7-day washout period. All subjects     will receive single doses of retosiban 100 mg, (treatment A) retosiban 800 mg (Treatment B),     moxifloxacin 400 mg (Treatment C) and placebo (Treatment D) in one of the four treatment     sequences (ABDC, BCAD, CDBA, DACB) following a Williams design Twelve-lead ECGs and     continuous Holter monitoring, clinical laboratory safety tests, vital sign measurements,     physical examinations, adverse event reports, and pharmacokinetic samples will be collected     throughout the study. In each study period, cardiac conduction will be measured using a     24-hour continuous 12-lead Holter monitor from the morning of Day 1 (dosing) until the     morning of Day 2.   "
120982|NCT01702363|"     The objective of this study is to evaluate the safety and tolerability of GSK573719     Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.   "
120983|NCT01702350|"     GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that     inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with     tRNA and is currently in development for the treatment of hospital acquired Gramnegative     infections.   "
120984|NCT01702337|"     This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and     the quadrivalent HPV vaccine (HPV-2).   "
120985|NCT01702324|"     The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on     plaque Psoriasis Vulgaris.      The study will include subjects at plaque stage from 5-20% body area involvement. A total of     30 subjects will be treated with cream application on affected areas twice daily for three     weeks.The efficacy of the preparation will be documented by PASI score, Global physician     assessment and photos.   "
121012|NCT01701973|"     This study tests the following hypotheses:      Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the     currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone     (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone     releasing hormone (GHRH).      Aim 2: Test the hypothesis that decreased degradation of GHRH during acute DPP4 inhibition     will result in an increase in endothelium-dependent vasodilation mediated by GH and     independent from GLP-1 in healthy lean adults.      This study promises to provide novel data regarding how this increasingly used class of     anti-diabetic drugs affects the pituitary GH axis and could affect blood vessel relaxation.     Growth hormone levels are low in the setting of obesity and pre-diabetes. A further study may     evaluate the effect of chronic DPP4 inhibitor therapy in a population of patients with     obesity and pre-diabetes.   "
120986|NCT01702311|"     Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of     diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting     information on BG levels at different time points during the day in order to assess glycemic     control and to guide insulin adjustment/correction doses. Although POC testing provides     insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of     insulin supplements that may result in increased frequency of hypoglycemia and is expensive     with an estimated annual cost in hospitals of several hundreds of millions of dollars in the     U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin     supplementation (correction doses) at bedtime in improving glycemic control and in preventing     hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of 250 non-ICU     medical and surgical patients treated with basal bolus regimen will undergo POC testing     before meals and bedtime (standard of care) and half of the patients will receive insulin     correction doses at bedtime for BG > 140 mg/dL following a sliding scale protocol, while the     other half will be followed without insulin supplementation at bedtime except for extreme     hyperglycemia (BG > 350 mg/dl). Patients will be recruited at Emory University Hospital and     Grady Memorial Hospital.   "
120987|NCT01702298|"     The purpose of this study is to examine the safety and tolerability of sitagliptin 100     mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus     with inadequate glycemic control on metformin.   "
120988|NCT01702285|"     The main purpose of this study is to determine the safety and tolerability of orally     administered CUDC-101 in cancer patients, and to determine a dose for further testing. This     study will also determine how well CUDC-101 is absorbed into the blood after being given     orally, assess CUDC-101 blood levels and what happens to the study drug in the body, and     study how the body reacts to the study drug and what effects it has on tumors. CUDC-101 has     been administered to cancer patients as an intravenous (IV) infusion in other research     studies, but has not been studied when given orally.   "
120989|NCT01702272|"     The objective of this study is to test individual donor samples (IDSs) with the     investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue     Assay in the clinical setting.   "
120992|NCT01702233|"     To evaluate functional, clinical, and subjective parameters in patients with rotator cuff     syndrome and bursitis treated with Traumeel® S injections versus corticosteroid injections     and versus placebo. 160 patients are planned to be randomised (i.e., 64 patients per active     treatment group and 32 patients in the placebo group) in 9 investigator sites in Germany,     Belgium and Spain.      Finally 176 patients have been randomized (73 Traumeel, 67 Fortecortin and 36 Placebo) and     175 of them received at least one dosage of treatment   "
120993|NCT01702220|"     The overall goals of the proposed research study are to: (1) examine quantitative outcomes in     a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community     Care, an information and referral intervention that represents care in a real-world     community-service environment, and (2) evaluate implementation feasibility, which includes     training community providers; examining program reach, engagement, acceptability, and     barriers-facilitators; and preparing practical tools for replicating the program.   "
120994|NCT01702207|"     Current standard prophylactic immunosuppression in renal transplantation includes tacrolimus,     a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been available as     a twice daily formulation marketed as Prograf® since 1997. It has recently become available     in an extended release formulation called Advagraf®, which is dosed once daily. Advagraf® has     been demonstrated to be therapeutically equivalent to Prograf® in the renal transplant     maintenance population, and as a result it has been is approved as an alternative to the     twice daily formulation in these patients. There is an evolving and expanding positive     clinical experience with Advagraf® in kidney transplantation and it has shown to be preferred     by many patients, due to the diminished dosing frequency. In clinical trials, Advagraf® has     been shown to have other potential benefits over Prograf® such as less inter and     intra-patient variability, improved cardiovascular profiles, and improved kidney function.     Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as well as a     lower Cmax or 'peak' concentration. The purpose of this study is to convert stabilized renal     transplant patients currently receiving Prograf® to Advagraf®, to investigate these potential     therapeutic benefits.      The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the     Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general     population. Surrogate markers are widely used in clinical trials to shorten follow-up     durations. In this study, the investigators will use the Framingham Risk Score and Reynold's     Risk Score to quantify changes in estimated cardiovascular risk. The investigators also     intend to examine novel inflammatory markers to investigate cardiovascular risk.      The investigators hypothesize that the more consistent drug exposure and lower Cmax noted     with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers of     inflammation in kidney transplant recipients.   "
120995|NCT01702194|"     The purpose of this study is to determine TD-1211 is processed by the body.   "
120996|NCT01702181|"     The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in     adult subjects with atopic dermatitis   "
120997|NCT01702168|"     Aim: To identify, assess, and address organizational context and provider-level barriers and     facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods     approach in a diverse community mental health center (CMHC), Massachusetts General Hospital     Chelsea Health Clinic (MGH Chelsea).      Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate,     heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider     motivation to learn EBT.   "
120998|NCT01702155|"     The purpose of this study is to determine the safety and efficacy of DFP-10917 given via     continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).   "
120999|NCT01702142|"     A team of researchers from the University of Wisconsin-Madison College of Engineering and     Oregon Health & Science University will test whether clinician training and the use of     organizational change strategies are sufficient for disseminating an evidence-based practice     (EBP), or if changes to both organizational systems and payer policy results in greater EBP     use. Demonstrating the role of payment policy as a driver in the adoption of evidence-based     practices could provide a contribution to dissemination and implementation science. This     study will employ an intervention that was developed through the Robert Wood Johnson     Foundation-funded Advancing Recovery (AR) program. In AR, payer/treatment organization     partnerships in 12 states collaborated to remove systemic barriers to the adoption of EBPs     such as medication-assisted treatment for substance abuse disorders. The resulting AR     Framework of payer and organizational change strategies will be tested against its ability     to increase the use of the addiction medication buprenorphine as compared to organizational     change strategies alone. Buprenorphine is an EBP for treating people addicted to heroin or     opioid-based pain medications for non-medical use. Buprenorphine has experienced low adoption     rates and is not a standard part of addiction treatment. In Ohio, the location of the study,     deaths to due to accidental overdoses of opioids has increased by 304% over the past decade     and surpassed auto accidents as the leading cause of accidental deaths in 2006. Ohio was     selected for the study because of the public health significance of opioid abuse and because     each county in Ohio acts as a stand-alone payer, offering 48 unique eligible payer     environments. This trial will develop a deeper understanding of the role payers and treatment     organizations play in implementing and disseminating EBPs and will focus on the public health     issue of rising opioid abuse.   "
121000|NCT01702129|"     Background: Site-specific delivery of anti-cancer therapeutics is paramount for both reducing     nonspecific toxicities and increasing efficacy of chemotherapeutic agents. Due to their small     molecular size and nonspecific mechanisms of action, most conventional chemotherapies result     in significant toxicities that limit the effectiveness of treatment and reduce the overall     quality of life for cancer patients. Encapsulation of these toxic agents inside lipid-based     carrier systems (so-called liposomes) results in passive targeting of the compounds to solid     tumors. The preferential delivery of liposomal drugs to solid tumors is mostly due to altered     barrier-properties of tumor-associated vessels. This results in both an improved delivery and     at the same time a significantly milder toxicity profile. Recently, the specificity of     delivery was further increased by attaching monoclonal antibodies or antibody fragments to     the surface of liposomes (=immunoliposomes, antibody-linked nanoparticles). Antibody-coated     immunoliposomes attach more selectively to antigens expressed on the target cells and they     are internalized more efficiently. Furthermore, there is evidence that drug resistance, a     major challenge in cancer treatment, may be overcome by such delivery systems. A logical and     accessible target, such as EGFR, is overexpressed on a variety of primary human cancer cells     and it is involved in signaling pathways that contribute both to tumor initiation and tumor     progression. Recently, the investigators have tested immunoliposomes against the epidermal     growth factor receptor (EGFR) in a preclinical setting. Based on the preclinical results we     have initiated this phase I clinical trial.      Study hypothesis: The investigators hypothesize that anti-EGFR-immunoliposomes selectively     deliver cytotoxic compounds to EGFR-overexpressing tumors cells. Specific delivery is     supposed to increase efficacy while reducing side-effects of the compound. The primary     objective of this phase 1 trial is the determination of the maximum tolerated dose (MTD) for     future phase 2 trials of this nanoparticle.   "
121001|NCT01702116|"     This is a study that compares two types of surgery for rectal cancer. There are two     procedures that can be used during this surgery, conventional abdominal resection (APR) and     extended (or extralevator) APR. The investigators are doing this research to see whether the     extralevator APR increases the likelihood that the edge of the tissue that is removed will be     more likely to be free from cancer cells compared with the conventional APR surgery. At this     time there is no evidence that one type of procedure is better at this than the other. The     objective of this research is to determine whether extralevator APR is more likely to have     clean margins (free of cancer) compared to the standard APR surgery.   "
121002|NCT01702103|"     Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief     of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from     baseline of Total Nasal Symptom Scores (TNSS).   "
121003|NCT01702090|"     The purpose of this study is to provide early access to TMC114 administered with low-dose     ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have     not received previous HIV treatment or have received early treatment without TMC114 regimens.   "
121004|NCT01702077|"     The aim of this study is to train patients with tic disorders to control activity in a region     of their brain that has been associated with the urge to tic. Patients will be given direct     feedback regarding activity in this brain area while they are undergoing functional magnetic     resonance imaging (fMRI) scanning, and will try to learn to control activity in the region     during these feedback sessions. In separate sessions, patients will be given sham feedback     based on the brain patterns of a prior subject rather than their own brain patterns. Our     primary hypothesis is that the biofeedback training will reduce their tic symptoms more than     the sham feedback.   "
121005|NCT01702064|"     This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination     with nilotinib in patients with chronic myeloid leukemia (CML).   "
121006|NCT01702051|"     Islet autotransplantation (IAT) is a therapeutic approach used to prevent pancreatogenic     diabetes or to reduce the severity of diabetes after a major pancreatectomy. Total     pancreatectomy with IAT is being used almost exclusively for treatment of chronic     pancreatitis. More recently, indications other than chronic pancreatitis have been reported     including IAT after extended pancreatectomy performed for the resection of benign tumors of     the mid-segment of the pancreas or IAT after total pancreatectomy for severe abdominal trauma     In this study, we study our experience with IAT for the treatment of a broader population of     patients undergoing pancreatic surgery including subjects with technically unfeasible or high     risk pancreatic anastomosis during partial pancreatectomy and subjects undergoing completion     pancreatectomy because of anastomosis leakage after pancreatoduodenectomy for nonmalignant or     malignant diseases.   "
121007|NCT01702038|"     The purpose of this study is to determine how B cell subsets and autoantibodies are related     to disease remission after rituximab treatment in subjects with Systemic Lupus Erythematosus     (SLE).   "
121008|NCT01702025|"     In low oxygen environments, such as altitude, some adults may become ill and suffer from     acute mountain sickness. Further, all adults will find that exercising becomes much more     difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of     this investigation is to study the effects of two drugs that may help people adjust to     high-altitude quickly, prevent them from becoming ill and improve their exercise performance.     The drugs are Methazolamide and Aminophylline.   "
121009|NCT01702012|"     A 12 month multi-center randomization controlled study. Participants will be randomized to     either a lifestyle education program or a meal replacement regimen with Almased, after an     initial examination of eligibility criteria.      Primary outcome-HbA1c   "
121010|NCT01701999|"     Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate     safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine     A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the     pentavalent botulinum (PBT) toxoid. This study is designed to determine neutralizing antibody     levels for botulinum toxin types A and B in healthy subjects who were previously immunized     with the PBT for occupational protection and who receive the rBV A/B. Subjects with titers of     the neutralizing antibodies against the toxins would be candidates for plasma donation for     BabyBIG production.   "
121011|NCT01701986|"     The goal of this clinical research study is to find the highest tolerable dose of gemcitabine     (out of 6 possible doses) that can be given in combination with busulfan and clofarabine     before an allogeneic stem cell transplant. Researchers also want to learn if this combination     can help to control lymphoma. The safety of this treatment will also be studied.      Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer     cells to die. It is commonly used in stem cell transplants.      Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may cause     the cancer cells to die.   "
121022|NCT01701843|"     The purpose of this exploratory study is to investigate the clinical efficacy of study drug     (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right     comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded,     randomised, single centre setting.   "
121013|NCT01701960|"     1% Lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal     mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and     visibility. Typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery.     However, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is     also used. This latter dose theoretically should have a lesser effect on cardiac stimulation     which increases the heart rate and blood pressure at the time of surgery. The nasal mucosa     has excellent absorbing ability which is great for the application of drugs but there is     concern for systemic absorption and side effects. Potential serious side effects can occur     with local injection such as hypertension, tachycardia, and cardiac arrhythmias. These side     effects occur mainly through the absorption of epinephrine. It is the goal of this study to     see if a weaker concentration of epinephrine (1:200,000) can maintain a good surgical field     with a decrease in hemodynamic side effects.   "
121014|NCT01701947|"     The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement     coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the     opinion of the treating physician, the benefits of administering selectively the missing     factor outweigh the potential risks associated with the administration of fresh-frozen     plasma.   "
121015|NCT01701934|"     The purpose of this study is to determine whether roflumilast can improve metabolic profile     and reduce visceral adiposity in patients with chronic obstructive pulmonary disease (COPD).   "
121016|NCT01701921|"     The purpose of this study is to determine whether pregabalin is effective in the treatment of     acute postoperative pain after cardiac surgery if administered before the surgery.   "
121017|NCT01701908|"     Incidence of Postoperative Pulmonary Complications (PPCs) varies from 2% to 19%, according to     the population under examination and the criteria used to define pulmonary complications.     There is no univocal definition of PPCs. Usually physicians associate atelectasis,     respiratory insufficiency, pneumonia, bronchospasm, necessity to reintubate. Moreover the     evaluation of risk factors has become difficult.      The endpoint of this study is to determine the actual incidence of respiratory postoperative     complications in patients undergoing general anesthesia for major abdominal surgery (general     surgery, gynecology, urology).      This is an observational, descriptive, prospective, multicentric study. Investigators are     going to enroll all the patients matching the inclusion criteria and follow them until     discharge (clinical phase). Then they will be followed up until one year later.   "
121018|NCT01701895|"     The purpose of this research study is to evaluate how easy it is for female HIV- positive     subjects taking Complera to comply with the dietary requirement using a food diary in the     short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association     between calorie intake and virologic suppression. A secondary goal of the study is to     evaluate subjects' attitudes towards contraception.   "
121019|NCT01701882|"     The purpose of the study is to investigate the benefits of switching away from efavirenz     (which patients are taking in combination with Kivexa® or as part of the combination pill,     Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty     with sleeping}, bad dreams etc). The investigators in this study will investigate the effect     of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and     rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new     component of the combination.      Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination     with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical     studies, where patients were starting HIV treatment for the first time.      This study will also investigate the safety (in terms of other side effects and the routine     blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness,     your viral load and CD4 counts, when you switch treatment to     tenofovir/emtricitabine/rilpivirine.   "
121020|NCT01701869|"     Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the     only one of the common causes that is still rising. The main effects of the disease are the     destruction and inflammation of lung tissue rendering breathing difficult. COPD has     significant effects on the quality of life of sufferers and the disease is predicted to be     the fifth most common cause of disability in the world by 2020. Patients with COPD are prone     to periods of worsening disease symptoms, known as exacerbations, which are often caused by     viral and bacterial infections of the lung and current vaccines appear to have little     efficacy in limiting these exacerbations. The loss of lung function caused by infectious     exacerbations is irreversible and patients who frequently exacerbate experience more rapid     disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species     that colonises the airways and causes exacerbations in COPD. With the development of more     sensitive molecular techniques it has been possible to ascertain that it is the acquisition     of new strains of NTHi that correlate strongly with exacerbations. However, not all patients     with COPD have NTHi in their lungs and the question remains as to why some COPD patients are     susceptible to such infections. This study aims to answer this question by comparing the     airways of COPD patients who are colonized by NTHi and those who are not to analyse whether     the levels of protective antibodies in the lungs and the function of the immune cells in the     NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity     with areas of lung damage ascertained by high resolution computed tomography. The aim of this     research is to better understand this apparent deficiency in airway immunity as this is     likely to impact on vaccine efficacy in COPD.   "
121021|NCT01701856|"     Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young     adults affecting approximately 1 in 1.000 people in western countries. The clinical     manifestations usually begin at the age of 20 to 40 years with a median age of 28 years at     onset with acute episodes of neurological dysfunction, followed by periods of partial or     complete remission and clinical stability in between relapses. This relapsing-remitting phase     (RR-MS) of the disease is usually followed by progressive clinical disability (secondary     progressive phase, SP-MS).      At present, there is no cure for MS. Based on the pathological concept that neuroinflammation     is the common element leading or contributing to neurodegenerative changes, immune     interventions have been introduced into clinical practice such as Natalizumab (Tysabri), a     humanized monoclonal antibody. Natalizumab (Tysabri) is indicated as a disease-modifying     monotherapy of highly active relapsing MS. The associated risks, especially progressive     multifocal leukoencephalopathy, necessitate active monitoring of patients and a continuous     discussion of optimum use of this drug. In clinical practice, the question how to manage     patients on natalizumab at a higher risk for progressive multifocal leukoencephalopathy     remains unresolved.      This prospective, controlled (comparison to the period prior to natalizumab treatment),     single-arm, open-label, multi-centre, phase IV study aims to evaluating the concept of     natalizumab de-escalation to interferon-beta-1b e.o.d in relapsing-remitting multiple     sclerosis patients, who consider stopping natalizumab due to a benefit-risk assessment. In     particular, to evaluating if interferon beta-1b treatment may be able to overcome the     recurrence of significant clinical and radiological disease activity after natalizumab     cessation and may keep disease activity better under control as compared to the time prior to     natalizumab.      The study population includes patients with relapsing-remitting multiple sclerosis (RR-MS)     being treated at least for 12 months with natalizumab and having decided to stop natalizumab     treatment and to de-escalate their therapy to a first line treatment with interferon beta-1b.     They will be treated during 12 months with interferon-beta 1b 250 mcg given subcutaneously     every other day. A 12-month follow-up period with the same treatment is planned.   "
121023|NCT01701830|"     The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with     carotid atherosclerosis and mediated by inflammation.   "
121024|NCT01701817|"     The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a     multicenter, prospective outpatient disease registry to evaluate the utilization of     target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin     inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the     collection and analysis of post-approval observational data needed for evaluating the     outcomes associated with these new agents when used in broader patient populations outside of     clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial     fibrillation (AF) as well as those who have been recently started on a target-specific oral     anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a     broad and contemporary view of AF therapy.   "
121025|NCT01701804|"     The purpose of this study is to investigate the effect of a non-surgical integrative package     consisting of Chuna herbal medicine, Chuna manual therapy, bee-venom pharmacoacupuncture,     acupuncture on failed back surgery syndrome through means of a prospective case series.   "
121066|NCT01701271|"     The purpose of this study is to determine whether the Hair Loss Prevention Lotion named     MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Androgenetic Alopecia.   "
121026|NCT01701791|"     Background: In Italy, several recent studies found that a large percentage of patients     attending Primary Care (PC) clinics meet criteria for at least one common mental disorder, as     they show high rates of depression, anxiety, and co-morbid anxiety and depression. These     patients may experience significant functional impairment and suffer from unexplained somatic     symptoms, and often remain undetected and untreated. Consistent evidence for the     effectiveness of organized care programs for depression, by improving quality of care and     treatment adherence, is now available. Fundamental elements of these programs include     algorithms to prompt the proper and timely implementation of evidence-based treatments,     structured outcome assessment and systematic outreach. Telemedicine tools may represent a     valuable strategy for improving depression outcomes in PC.      Aims: 1.To develop and employ computer-based assessment to more accurately and timely detect     patient depression in PC settings; 2.To evaluate the feasibility and effectiveness of a care     support program developed in conjunction with the PC-based assessment for patients suffering     from depression, as based on two main objectives: 2a.To support GP decisions with treatment     algorithms and improve the quality of GP and mental health service collaboration; 2b.To     improve patient compliance and treatment adherence by using appropriate telecommunication     tools and technologically advanced tools to conduct systematic routine assessment. Although     much of this system will be computer-based, live telephonic and in-person contacts will also     be included as needed.      Study Design: The study is a randomized controlled trial, involving four PC group clinics     (GCs) located in two areas of Northern Italy. Two PC clinics will use the experimental     protocol; the other two will serve as controls.      The study will compare two different conditions:        -  Group 1 (experimental): GPs will use a Computer Decision Support System with treatment          algorithms and advice and supervision from a consultant psychiatrist. Patients will          receive reminders via mobile texting or automatic mobile (or landline) phone calls to          improve adherence to the treatment prescribed.        -  Group 2 (control): GPs will provide TAU, will make their own decisions and will          therefore not use the CDSS. Patients will not receive any reminders. All enrolled          patients will be administered and will fill in the IDS-SR at baseline, 3 and 6-months:          the IDS-SR score will be used as a primary endpoint.   "
121027|NCT01701778|"     The purpose of this study is to compare the effects of caudal dexmedetomidine with     intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower     abdominal surgeries.   "
121028|NCT01701765|"     An increasing number of severely ill patients require long-term care in non-hospital     Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed     longitudinal studies on fairly larger samples of residents have provided important     information about this population. The PERDOVE study is the first study carried out in Italy     aimed at obtaining comprehensive data about the course and outcome of patients living in RFs,     and test whether discharge to independent accommodations is a real option for many patients.     The major aims are three: (1) to describe the sociodemographic, clinical, and     treatment-related characteristics of patients treated in RFs during an index period in 2010;     (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up;     and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each     individual patient. The primary endpoint was discharge within one year as a measure of good     outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging     to the St John of God Order, located in Northern Italy. The first step involves the     evaluation of all RFs with a Structure Schedule, which assesses the following areas:     logistics structure, general organization: internal rules, meals, clothing and personal     hygiene; staff and users' characteristics and meetings, documentation system and evaluation     activities; rehabilitative activities provided inside the RF itself. In the second step a     research assistant completed a standardised assessment of each resident with the manager and     staff; clinical diagnoses were made by treating clinicians. A number of standardised     instruments were administered. At one year follow-up, changes in clinical and life conditions     of the patients were evaluated and selected rating scales were administered again. For     patients discharged to the community or to other RFs, a research assistant contacted the     patient's psychiatrist and asked him/her to fill out the follow-up documentation. With regard     to residents' discharge, investigators hypothesised that the likelihood of community     discharge would be associated both with the level of social support outside the facilities,     and with the degree of patients' psychological and social impairment.   "
121029|NCT01701752|"     This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated     with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age,     subjects that are more representative of the target population. Both formulations will be     administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV)     vaccine.   "
121030|NCT01701739|"     This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and     safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In     period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will     receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on     study treatment is one month.   "
121031|NCT01701726|"     This is a large scale, open-label, multicenter, randomized controlled clinical trial with     four parallel arms. This trial aims to evaluate the effectiveness of affected meridian     acupuncture for patients with mild hypertension,with respect to decreasing their blood     pressure, safety of acupuncture ,and improving their quality of life as well.   "
121032|NCT01701713|"     The purpose of this study is to determine the safety of transcranial direct current     stimulation in aphasia therapy in acute and post-acute stroke.   "
121040|NCT01701609|"     Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia     improving functional outcome. But most of the studies have involved participants who are in     average in their mid 30s, and little is known about the efficacy of CRT in adolescents with     early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in     improving cognitive performance and functional outcome in adolescents with EOS. We expect to     find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.   "
121041|NCT01701596|"     This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in     nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary     intervention (PCI) procedure.   "
121042|NCT01701583|"     This study looks at changes in cell proteins in people with chronic hives treated with     omalizumab.   "
121033|NCT01701700|"     Over 1 million people in the UK suffer from untreatable visual impairment, many of them     elderly. The major complaint of visually impaired people is their inability to carry out     simple tasks, especially those involving reading. It is known that this activity limitation     is a major cause of depression in an older population, and it is reflected in reduced quality     of life. Low vision clinics, mostly based within hospital ophthalmology departments, dispense     optical magnifiers to allow patients to carry out these tasks again, but these devices do     have limitations (unusual posture, short working distance, monocular viewing). Although     electronic magnifiers have been around since the 1960s, they were initially very large and     expensive. Recent advances in technology have brought about an explosion in the number and     range of portable and moderately-priced aids, which can be used binocularly, in a natural     working position: these are currently not available through the NHS. Evidence is needed as to     whether these portable hand-held electronic magnifiers could offer a significant benefit to     the majority of patients, and therefore whether they should be routinely dispensed in low     vision clinics.      The proposed study is a two-arm randomised crossover trial with existing users of optical     magnifiers being assigned to use a hand-held electronic magnifier in addition to their     existing devices for 2 months. Reading and task performance will be measured with the aid,     and compared to the performance with optical aids, and the patient will be asked to report on     the comparisons between the aids.   "
121079|NCT01701102|"     Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in     ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic     (a medication that, when injected around nerves, blocks nerve conduction, resulting in     numbness and weakness) used in the spine, but too low a dose can result in an incomplete     block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of     fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this     study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with     fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.   "
134766|NCT01520857|"     The purpose of the study is to assess whether spinal anesthesia is superior to the standard     general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal     hernia repair (TAPP).   "
121034|NCT01701687|"     Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to     correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an     inert dye which is purely extracted from the blood by liver cells, and is hence an excellent     marker of both liver cell function and overall liver blood flow. There is little data for     either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish     the accuracy of these liver biomarkers in predicting important liver related outcomes (death,     transplantation and hospital readmission with cirrhosis related consequences) in patients     with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the     serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality     of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated     alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine     tests and qualitative questionnaires. These will be measured during their initial hospital     admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4     and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these     investigations. The end of the study for individual patients will be patient death, liver     transplantation or 6 month from study enrolment; whichever occurs first.   "
121035|NCT01701674|"     Purpose of this Pilot Study: The investigators want to study the safety, side effects, and     benefits of tumor infiltrating lymphocytes (TILs), when they are given with the drug     ipilimumab. Ipilimumab is a type of immunotherapy - a drug that is used to boost the ability     of the immune system to fight cancer, infection, and other diseases.   "
121036|NCT01701661|"     Randomized controlled trial, a method used to implement the random allocation sequence is     numbered containers.      The aim of the study is to compare compression therapy with compression stockings and surgery     eliminating superficial venous reflux in patients with duplex ultrasound verified superficial     venous reflux without skin changes or ulceration.   "
121037|NCT01701648|"     Vitiligo is an acquired skin disease that significantly impacts the quality of life of     patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but     the results are variable.      This single center, single blind clinical trial comparing another treatment and also no     treatment was designed to assess the efficacy of autologous monocyte transplantation in     monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients     will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane     and will provide an untreated area as a control.   "
121038|NCT01701635|"     A culturally-relevant, theoretically and empirically sound, patient-centered, standardized     disclosure intervention that can be integrated into routine clinical pediatric HIV care has     potential to prevent transmission and improve the welfare of children and their caregivers in     Ghana and other resource-limited settings. Results from this project will also further an     understanding of factors and processes driving pediatric HIV disclosure.The study hypothesis     is that several key barriers to disclosure of HIV status can be modified and the process of     disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian     concept.   "
121039|NCT01701622|"     Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood     pressure) and overall cardiovascular disease risk in several studies. The relationship has     even been noted to be independent of metabolic syndrome and kidney function. It has been     repeatedly noted that hyperuricemia was an independent risk factor of death in those at high     cardiovascular disease risk. A recent review concluded that there is strong evidence that     hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.      Although this correlation of hypertension and hyperuricemia is known, there has only been one     published study that has evaluated if lowering the uric acid would reduce the blood pressure.     The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased     the blood pressure. Despite this, further evaluation of this therapeutic approach has not     been studied.      The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood     pressure lowering effects superior to allopurinol in patients diagnosed with gout.   "
121080|NCT01701089|"     This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the     brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with     Alzheimer disease and in healthy volunteers. Patients and volunteers will receive multiple     doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.   "
121209|NCT01699399|"     This prospective, randomized controlled trial compares traditional air insufflation with     water immersion and water exchange in patients undergoing colonoscopy using on demand     sedation. We test the hypothesis that compared with air insufflation the proportion of     patients who require on demand sedation during colonoscopy will be significantly lowered by     water immersion and water exchange, and water exchange will produce the greatest reduction   "
121045|NCT01701544|"     We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving     cognitive deficits in PD patients referred and eligible for conventional DBS treatment for     coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive     impairments (including but not restricted to deficits in attention and working memory) will     have bilateral electrodes implanted to ensure that superficial contacts lie in the     conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see     figure 1). We will place electrodes using our conventional image guided, stereotactic     frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2     groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or     switched off separated by a 1 month washout period, following which the patient will cross     over to have the opposite condition for a further 3 months- see timeline. At the end of the     crossover period, all patients will be invited for continued follow up with stimulation     switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients     will be given the option of receiving additional conventional stimulation to the motor GPi,     through the higher contacts of each electrode, at the end of the crossover period.   "
121046|NCT01701531|"     The objective of this study is to measure the change in hemoglobin levels after the     administration of an amino acid based, RBC precursor formulation.   "
121047|NCT01701518|"     To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected     at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for     idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as     demonstrated by a gain in vision and decreased in retinal thickness and volume.   "
121048|NCT01701505|"     The purpose of this study is to assess the efficacy and safety of intranasally administered     Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.   "
121049|NCT01701492|"     This is an observational study to collect information by use of performance-based measures     and survey questionnaires. It does not include interventions aimed at altering patient     outcome.      Advances in pediatric hematopoietic stem cell transplantation (SCT) have resulted in improved     survival and prompted increased attention to the potential adverse late effects of this     procedure. Survivors of SCT are thought to be at risk for neurocognitive deficits as a result     of their exposure to a number of potentially neurotoxic agents. Prior studies done by our     group and others have demonstrated generally stable cognitive function in the first 5 years     following transplant, with little evidence of significant declines. However, there has been     almost no research to date on the status of very long-term (> 5 years post-transplant)     survivors. In this study, we will evaluate a large sample of long-term survivors of     allogeneic SCT using measures of intelligence, academic achievement, and specific cognitive     functions such as attention, working memory and processing speed. We will also obtain     measures of behavioral functioning and quality of life. We will examine how this group of     survivors are functioning relative to normative expectations, and in comparison to community     controls without a history of serious illness, matched on age, gender, race/ethnicity, and     socioeconomic status. We will also examine the relationship between cognitive function and     psychosocial function and quality of life in this population.   "
121050|NCT01701479|"     The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination     with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and young     people with primary refractory or relapsed neuroblastoma without intravenous morphine.   "
121051|NCT01701466|"     The purpose of this study is to determine whether NeoVIDERM is effective at preventing     radiation dermatitis in patients receiving external beam radiation therapy to the head and     neck or breast areas.   "
121052|NCT01701453|"     1. Objective To test the safety of 6 month-duration of DAPT compared to conventional          12-month-or-longer duration after second-generation DES implantation in patients with          acute coronary syndrome.        2. Hypothesis A 6-month duration of DAPT is non-inferior to a conventional          12-month-or-longer duration of DAPT at preventing the occurrence of major adverse          cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES          implantation in patients with ACS   "
121053|NCT01701440|"     In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and     improve contour and cosmesis.   "
121054|NCT01701427|"     Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper     structures as well as the skin. Whether this is one combined pain syndrome, where for     instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain     conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical     stimulation in deeper tissues in the groin and recording the skin sensory function, this     hypothesis will be tested   "
121064|NCT01701297|"     Research question: Do oral probiotics in patients with cirrhosis and ascites reduce     intestinal bacterial concentrations, ascitic bacterial DNA, SBP and bacteraemia compared to     antibiotics or placebo?      This study is designed to investigate the effects of an oral probiotic (VSL#3; a mixture of     healthy bacteria for the intestines) compared to an antibiotic or placebo in preventing     infection developing in the abdominal fluid (ascites) that collects in patients with     advanced liver disease (cirrhosis). Patients already having had infection will be excluded     from the study. Clear inclusion and exclusion criteria will be met and patients will be     monitored throughout the study to examine whether they have required more hospitalisations,     their rate infection in abdominal fluid or elsewhere and the level of liver function.   "
121055|NCT01701414|"     The purpose of this study is to determine if ultrasound guided femoral nerve blocks     (localized anesthesia in the upper thigh) provide effective pain relief in adult patients     with hip fractures in the emergency department and to determine if femoral nerve blocks can     then be used to reduce the use of injected analgesia (anesthesia), therefore also causing     fewer adverse effects associated with injected analgesia (such as bruising at the site of     injection).      100 patients with hip fractures will be enrolled in the study. Patients will be randomly     assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care     (SC), which is injected analgesia alone.      Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine     (a local anesthetic of long duration) injected into the front of the thigh, at the site of     pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so     that no neither the patient or the treating physician knows to which group the patient was     randomized. All blocks will be performed in the emergency department by an emergency     physician trained in the use of ultrasound and ultrasound guided nerve blocks.      Subjects will be asked to rate their pain on a numeric pain scale both before and after     intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is in     the ER still). Additional data to be collected includes demographics, vital signs, and course     of treatment resulting from the ED visit.      Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly     decrease or eliminate the need for narcotics.   "
121210|NCT01699386|"     Effects on weight will be monitored in healthy infant subjects consuming assigned infant     formulas.   "
121057|NCT01701388|"     This study seeks to test the safety and efficacy of the Esko device in SCI population and in     populations with similar neurological weakness to the SCI population. The device can     currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as     follows:        -  Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance          while wearing the device as noted by subject's ability to safely achieve standing          balance for 30 sec without loss of balance.        -  Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to          safely ambulate 10 meters to be assessed using the 10 meter walk test.        -  Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in          both static and dynamic activities as determined by a trained physical therapist.        -  Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with          training of the device as noted by subjective questionnaires that will be assessed          following each training session.   "
121058|NCT01701375|"     1.1 Primary Objectives        -  To determine the feasibility, tolerability, and toxicities of administering the          selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and          Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk          myelodysplasias (MDS), including primary refractory disease        -  To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts        -  To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential          combination with ara-C and Mitoxantrone        -  To determine if the timed sequential combination of PD 0332991 with ara-C and          mitoxantrone can induce clinical responses in adults with relapsed or refractory acute          leukemias and high-risk MDS      1.2 Secondary Objectives:        -  To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell          populations in vivo        -  To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest          malignant cells in the G 1 phase of cell cycle, followed by synchronized release of          those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C          cytotoxicity   "
121059|NCT01701362|"     This study is designed to investigate if pregabalin is effective in treating neuropathic     (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such     as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia     repair, thoracotomy, mastectomy, focal/localized burns or crush injury.   "
121060|NCT01701349|"     This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin     given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with     chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC).     The primary objective of the study is to determine overall survival. A maximum of 300     subjects will be recruited from approximately 75 multinational sites of which approximately     35 will be located in the United States.   "
121061|NCT01701336|"     The purpose of this study is to determine whether administration of recombinant IMPs Ad6NSmut     and MVA-NSmut (experimental vaccines for hepatitis C) in HCV chronically infected patients in     combination with the standard Interferon/ribavirin therapy is safe and induces an     immunological response.   "
121062|NCT01701323|"     This pilot clinical trial studies infusion of laboratory-grown donor cord blood cells     following combination chemotherapy in treating younger patients with acute myeloid leukemia     that has returned or that does not respond to treatment. Chemotherapy drugs work in different     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. Chemotherapy also kills healthy     infection-fighting cells, increasing the risk of infection. The infusion of laboratory-grown     cord blood cells may be able to replace blood-forming cells that were destroyed by     chemotherapy. This may decrease the risk of infection following chemotherapy, and allow for     more chemotherapy to be given so that more cancer cells are killed.   "
121063|NCT01701310|"     116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will     be randomized to receive either oral ferrous sulphate (control) or intravenous ferric     carboxymaltose (intervention).      It is hypothesized that intravenous iron supplementation is more efficacious than oral iron     therapy.   "
121089|NCT01700972|"     The current protocol for myocardial perfusion imaging (MPI) entails imaging within 30-45     minutes after radiotracer injection, for both rest and stress studies. We hypothesize that     early imaging 10 minutes after radiotracer injection provides high image quality and     diagnostic accuracy comparable to 30-45 minutes MPI.   "
121150|NCT01700205|"     The overarching goal of the research we propose here is to conduct a randomized clinical     trial to specify the physiologic and behavioral mechanisms by which infant-formula     composition affects all aspects of energy balance and growth during the first years of life.   "
121065|NCT01701284|"     Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is     associated with high rates of depression and anxiety among its sufferers, and cancer patients     with depression usually have worse treatment outcomes and long-term survival. Surprisingly,     many cancer patients with depression do not receive treatment for their depression, perhaps     because treatments for cancer-related depression are usually adapted from those used in     non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients     with depression are more likely to have a long latency of anti-depressant drug action,     negative drug-drug interactions with cancer chemotherapies and an increased susceptibility     for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new     treatment modality for depression that affects the brain directly with no systemic side     effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared     by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder,     and now is being evaluated for a wide array of additional psychiatric indications. This     randomized, open label, two-arm, pilot study will investigate the safety, tolerability,     feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided     rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly     reduce symptoms of depression and that right-sided slow rTMS will be more effective than     left-sided fast rTMS for the treatment of severe anxiety.   "
121067|NCT01701258|"     Severe childhood adversity, including childhood sexual abuse (CSA), explains 32-44% of     psychiatric disorders and is associated with substantially increased risks for depression and     substance abuse later in life. However, 20-40% of adults with a history of CSA report little     to no consequences. The neurobiological underpinnings associated with adaptive (resilience)     and maladaptive consequences of CSA remain largely unknown. The goal of this study is to     investigate brain pathways within adult females (with a history of CSA that occurred between     the ages of 5-9) with and without a current diagnosis of major depressive disorder (MDD). We     hypothesize that the CSA/MDD participants will be characterized by (1) reduced reward     responsiveness and prefrontal cortex activity, but increased cortisol levels, (2) reduced     dopamine activity, and (3) reduced dopamine transporter binding. The over-arching purpose of     the study is to (1) identify individuals at risk for psychopathology and maladaptive     behavior, (2) prevent re-victimization, and (3) develop more targeted therapeutic     interventions.      This study involves 4 sessions, described below.      Session 1 (SCID Session) The first session takes place at the Center for Depression, Anxiety,     and Stress Research (CDASR) or Neuroimaging Center (both at McLean Hospital) and involves     consenting, a clinical evaluation, a series of questionnaires, and a medical assessment.      Session 2 or 3 (fMRI Session) The third session takes place at the Neuroimaging Center. Using     a double-blind design, participants will be administered either amisulpride (50 mg) or     placebo. Participants will complete the Monetary Incentive Delay (MID) task during functional     magnetic resonance imaging (fMRI) and the Probabilistic Stimulus Selection Task (PSST)     afterwards.      Session 2 or 3 (PET Session) This session takes place at Massachusetts General Hospital. 9     mCi of [11C] altropane will be injected by a trained nuclear medicine technician and positron     emission tomography (PET) scanning will begin. Prior to the PET scan, a blood serum pregnancy     test will be administered for females.      Session 4 (ERP Session) The fourth session takes place at the CDASR and involves an     electroencephalography (EEG) recording, the Probabilistic Reward Task (PRT), and collecting     saliva samples to assess cortisol levels.   "
121068|NCT01701245|"     Subjects enrolled into this 10 week study will for the first two weeks document the number of     cluster headaches and the means of treating (medication) of these attacks. Subjects will then     be randomized to into either two groups. The first group is continuing with standard of care     and the second group is treatment with the investigational device (GammaCore) for a period of     4 weeks. After this 4 week period, all subjects will treat with the GammaCore for another 4     week period. It is hypothesized the the treatment group will have a reduction in mean cluster     headaches per week by 50% compared to the standard of care group.   "
121069|NCT01701232|"     This international multi-center, randomized, controlled, open-label study will investigate     the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (NN: rituximab, CJSC     Biocad) versus MabThera (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a     monotherapy of patients with indolent non-Hodgkin's lymphoma.      Patients will be randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week     for 4 weeks or MabThera at the same regimen.   "
121070|NCT01701219|"     This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus     aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia     persisting after at least 72 hours of vancomycin and/or daptomycin treatment.   "
121071|NCT01701206|"     This study seeks to determine whether social networking technologies can be used to increase     HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply a     diffusion of innovations style intervention to social media to increase HIV testing.   "
121072|NCT01701193|"     The purpose of this study is to determine whether an amino acid is an effective treatment to     prevent abdominal/pelvic scar tissue.   "
121073|NCT01701180|"     Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin     has prosocial effects. However, the neural substrates of these effects are still unclear. The     investigators hypothesized that a single dose administration of oxytocin should increase     empathogenic and affiliative responses and that these effects are mediated by an increased     insula activity.   "
121074|NCT01701167|"     The purpose of this study will evaluate new technologies that have been included in the new     PCA-9000A PET/CT System.   "
121075|NCT01701154|"     The purpose of the study is to determine if respiratory muscle strength training will be     beneficial for inspiratory and expiratory muscle strength in adults and children with Pompe     disease.   "
121087|NCT01700998|"     Acute renal failure (ARF) is a serious and common complication in hospitalized patients,     occurring in more than 25% of intensive care unit (ICU) patients. Hypomagnesemia is a common     disorder, occurring in approximately 12% of hospitalized patients, with an incidence of 60%     in ICU patients. The majority of those patients have are asymptomatic hypomagnesemia, and     patients with mild hypomagnesemia do not need treatment, only the correction of the     underlying cause. Hypomagnesemia potentiates postischemic renal failure in rats, and is     associated, in humans, with acute renal failure. To date, there is no study that demonstrated     a benefit of maintain normal levels of magnesium in the incidence of ARF in critically ill     patients. Thus, we suggest that a treatment aimed to maintain normal magnesium levels during     ICU stay can decrease the incidence of ARF. We will perform a randomized clinical trial that     will include all patients admitted to an ICU that, develop hypomagnesemia. It will be     excluded from the study: patients younger than 18 years, participants from other studies,     pregnant women, patients with creatinine greater than or equal to 3.5 mg / dl or on dialysis,     patients who used intravenous contrast for radiological studies, patients weighing less than     40kg, suffering from advanced malignant disease, with severe hypomagnesemia (serum magnesium     less than or equal to 1.1 mg / dl), with a diagnosis of Torsades de Pointes or symptomatic     hypomagnesemia prior to randomization. Patients included in the study will be randomized to     one of the following groups: placebo (saline solution 0.9%) or 50% Magnesium Sulfate.     Patients will receive an administration of 48 mEq Magnesium diluted in 250 ml saline 0.9% for     24 hours in an infusion rate of 10.4 ml / hr. Therapy will be continued for 3 days, and     repeated during ICU stay to maintain magnesium levels in the normal range. Placebo group will     receive exactly the same infusion only with saline administration. The therapy will be     discontinued if the patient has hypermagnesemia or signs of magnesium intoxication. The main     outcome measurement will be the occurrence of ARF during ICU stay.   "
121076|NCT01701141|"     Major depressive disorder (MDD) is often characterized by anhedonia and impaired ability to     modulate behavior as a function of rewards. However, the neurobiology of anhedonia and     reduced reward responsiveness remains largely unknown. Because dopamine (DA) plays a critical     role in goal-directed behavior and reinforcement learning, DA dysregulation might play an     important role. In fact, several lines of evidence suggest that down-regulation of DA     transmission might characterize depression vulnerability and the emergence of depressive     symptoms. The current study seeks to elucidate the role of DA dysfunction in MDD. We     hypothesize that MDD subjects will show reduced DAT binding potential, reduced reward     learning in the probabilistic reward task, and abnormal functional magnetic resonance imaging     (fMRI) activation in dorsal and ventral striatal regions during an instrumental learning     task.      This study will include three sessions.      The first will take place at Massachusetts General Hospital or at McLean Hospital's Center     for Depression, Anxiety and Stress Research. The aims of this session will be to (a) explain     the study; (b) collect written informed consent, and (c) assess the subject's eligibility.      Following this, another session (either second or third in order) will take place at the MGH     PET Imaging Laboratory. Participants will complete a PET scan and a probabilistic reward task     designed to measure reward learning and sensitivity to reward. The radioactive tracer     utilized is 11C-altropane.      Another session (either second or third in order) will take place at the McLean Hospital     Neuroimaging Center. Participants will complete an instrumental learning task while in the     fMRI, followed by a social reinforcement learning task and an implicit learning serial     reaction time task upon completion of the scan. In the instrumental learning task,     participants have the opportunity to earn money but need to learn, by trial and error,     stimulus-outcome associations. The social reinforcement learning task is designed to     investigate whether learning deficits in MDD are specific to learning from monetary     incentives or whether the learning deficits are more global and are affected when learning     from social rewards and punishments. Participants will also complete an implicit learning     serial reaction time task, designed to exclude the possibility of global learning deficits in     MDD.   "
121077|NCT01701128|"     The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and     without a strengthening component, on functional mobility, gait and quality of life in     patients with Parkinson's disease (PD). The rationale for a study of this type stems from the     hypothesis that treadmill training may act as an external pacemaker and enhance some     properties of gait. There is a need for larger scale randomized controlled trials comparing     the effects of treadmill training to control groups that receive similar amounts of     attention. To date, no study has combined TT and muscle strengthening, likely the optimal     form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72     one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill     training will considerably improve walking parameters and the well being of people with PD.   "
121078|NCT01701115|"     The purpose of this study is to determine if a decrease in the standard volume of local     anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate     anesthesia for the procedure and decrease the amount of time until you are ready for     discharge from the hospital.   "
121211|NCT01699373|"     A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with     manual palpation to identify landmarks for performance of spinal anaesthesia.   "
121081|NCT01701076|"     Almost all patients with multiple myeloma who survive initial treatment will eventually     relapse and require further therapy.      Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large     randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months     for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior     therapies, respectively [1-3]. Continuous treatment with lenalidomide and dexamethasone until     disease progression is therefore considered a standard therapy for second line treatment in     multiple myeloma patients. However, only a relatively low rate of high quality response (CR,     complete response and VGPR, very good partial response) is achieved. High quality responses     are associated with with improved progression-free survival and overall survival [4].      Trial: The aim of this trial is to improve high quality response rates for patients with     relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved     by the addition a third anti-myeloma drug (bendamustine) to the established backbone of     lenalidomide/ dexamethasone.      Treatment regimen:        -  Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide          25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75years) d 1, 8, 15, 22.        -  Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg /          20mg (for patients > 75 years) d 1, 8, 15, 22.      Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is     mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe     neutropenia.      The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this     aim is achieved, the treatment of bendamustine in combination with the established     lenalidomide/ dexamethasone regimen will be considered promising.      Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.   "
121082|NCT01701063|"     The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a     carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a     telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.   "
121083|NCT01701050|"     Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly     characterize circulating tumor cells (CTC) for tumor markers that predict endocrine     sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been     demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed     that can be calculated for each patient using the CTC enumeration and marker results. The     primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic     breast cancer patients before the initiation of a new endocrine therapy for the     identification of patients that will progress rapidly.   "
121084|NCT01701037|"     This phase II trial studies how well giving dabrafenib alone and in combination with     trametinib before surgery works in treating patients with advanced melanoma that can be     removed by surgery. Studying samples of tumor tissue in the laboratory from patients     receiving dabrafenib and trametinib may help doctors learn more about the effects of these     drugs on cells and help identify biomarkers that determine which patients will respond to     these drugs best.   "
121085|NCT01701024|"     The primary objective of this study is to compare the efficacy and safety and tolerability of     ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.   "
121086|NCT01701011|"     Background of the study:      Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman     and her partner. Most stressful for the couple is waiting for the result of the treatment,     the period after the embryotransfer until the pregnancy test or menstruation and an     unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples     during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp     copingintervention has been developed based on the stress theory of Lazarus for women to use     at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal.     Research has demonstrated that using this copingstyle can have a positive impact in health     related circumstances.   "
121088|NCT01700985|"     Corticosteroids are one of the mainstays of treatment for subjects with     corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to     determine and compare the efficacy and safety of a formulation of 122-0551 versus the     corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for     14 consecutive days.   "
121104|NCT01700777|"     A randomized control trial of HABIT-ILE therapy compared with regular / conventional     intervention (same amount of hours). The protocols have been developed on the basis of     bimanual therapy (HABIT) developed at Columbia University.   "
121090|NCT01700959|"     Primary objective:        1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult          survivors of childhood cancer.      Secondary objectives:        1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in          long-term childhood cancer survivors.        2. To investigate whether improvement in sleep onset latency due to melatonin treatment is          associated with neurocognitive improvement in long-term childhood cancer survivors.      This study is a randomized double-blind placebo controlled trial of time release melatonin     for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning     and/or difficulty falling asleep.   "
121108|NCT01700751|"     This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab     vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem     cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or     myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and methotrexate     may result in a significant reduction of graft versus host disease in these patients.   "
121265|NCT01698671|"     The purpose of the study is to assess the performance and safety of the InterGard Synergy     vascular graft.   "
121091|NCT01700946|"     The overall objective of this protocol is to improve the cure rate of relapsed precursor     B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma.      This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or     lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive     different therapy. Treatment will consist of chemotherapy for SR participants, and     chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse.     Induction therapy consists of three blocks of chemotherapy. The first block is a novel     immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical     natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total     duration of approximately 2 years. HR participants will be candidates for HSCT and will     proceed to transplant once a suitable donor is found and their minimal residual disease (MRD)     is negative.   "
121092|NCT01700933|"     Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability.     The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a     well-documented effect on pain and function in patients with osteoarthritis of the hip. It is     sought an optimal dose of exercise, in which this study will help to investigate.      We hypothesize that an exercise program designed to have a high number of repetitions will     benefit the outcome of the training in a more positive way than a low-repetition based     program.   "
121093|NCT01700920|"     The purpose of this study is to analyze the safety and feasibility of direct administration     intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients     with femoral osteonecrosis.   "
121094|NCT01700907|"     Various issues had been pointed out when undergoing the anesthesia for elderly patients with     sevoflurane, such as delayed emergence, post-operative trouble with swallowing.      Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the     better emergence, along with the recent progress on optimization of delivered amount of     anesthesia.      The purpose of this study is to compare the time to emergence in long elderly patient cases     with desflurane or sevoflurane, with the recently developed drug-delivery optimization system     Aisys® (GE Healthcare Japan).   "
121095|NCT01700894|"     African American (AA) women have the lowest physical activity (PA) levels, which contributes     to substantial disparities in cardiovascular health and depressive symptoms. There is a need     to examine ways to promote PA that are appealing, applicable to clinical practice, and     cost-effective. The purpose of this clinical trial is to test the efficacy of the Women's     Walking Program (WWP), consisting of a lifestyle PA prescription and group visit delivery     model, with or without tailored telephone contacts between group visits for increasing     adherence to PA and improving health outcomes. Two telephone contact strategies will be     compared against a no-telephone control condition: a person-administered contact strategy     using brief motivational interviewing and an automated contact strategy using a telephone     computer-linked system. Group visits and telephone contacts are designed to increase     adherence to lifestyle PA with an emphasis on accumulation of 3,000 steps daily over     baseline. The aims of this study are (1) to compare the initial (adoption 24 weeks) and     longer-term (maintenance 2nd 24 weeks) effectiveness of the WWP plus person-administered     telephone contacts, WWP plus automated telephone contacts, and the WWP without telephone     contacts on (a) increasing adherence to lifestyle PA, (b) improving health outcomes (aerobic     fitness, body composition, depressive symptoms), (c) improving self-efficacy (confidence in     one's ability to be physically active) and outcome expectations (expected benefits to being     more active); and (2) to compare cost-effectiveness of the three telephone treatment     conditions in relation to adherence to lifestyle PA and health outcomes.      The investigators will randomly assignment of the order of administering the three conditions     to six community health care sites. These six sites are similar with respect to race,     socioeconomic status, and residential mobility. The study will include 288 sedentary AA women     aged 40 to 65 years who have no major signs or symptoms of cardiovascular disease (CVD); no     history of myocardial infarction, stroke, or diabetics with elevated HgA1c; BP < 160/100.      Initial screening will occur in person or over the phone. Further screening at the data     collection site with an advanced practice nurse will include blood work for glucose and     lipoproteins, a history and physical, and resting EKG. At baseline, 24 and 48 weeks all women     who are eligible will: be given questionnaires on physical activity, health and factors that     influence their physical activity; have their height, weight, waist circumference measured;     and do a two minute step test. All three treatment group will attend 5 group visits every 5     weeks during adoption (first 24 weeks) and 1 booster group visit during maintenance (week     36). The group visit consists of brief individual time with a staff member followed by a     group visit with motivational videotapes. All treatment groups will self-monitor their     physical activity with accelerometers and enter their step data into a voice response system.      The groups receiving the automated telephone contact strategy and the group receiving the     person telephone contact strategy will have the same number and spacing of the telephone     contacts (nine 10- to 15-minute telephone contacts delivered every two to three weeks between     group visits during adoption and two telephone contacts [weeks 28, 43] during maintenance).     Using motivational interviewing, a nurse will tailor the telephone discussion to the person     telephone contact group to match the participant's needs, experiences, barriers, motivation,     and confidence. Women in the automated telephone contact group will receive an automated call     with feedback on their progress based on the information they reported into the ATCL system.     The automated telephone contact system will deliver feedback on progress, problem solving,     goal-setting, and support. All information will be delivered in the voice of one of our staff     members. The third treatment group will receive no telephone contacts between group visits.      Potential risks exist for women who have medical problems, which contraindicate physical     exercise. Additional risks associated with the walking program include safety and injury.     There are potential risks of infection at the site of the one time finger blood withdrawal.     Potential benefits to subjects include improved aerobic fitness, blood cholesterol, body     composition and blood pressure and fewer symptoms. The subjects will be given a physical     activity prescription that should benefit them through life and decrease their risk for CVD.      Women will be recruited throughout the West and South side of Chicago. They will give verbal     consent at the screening questionnaire and sign an informed consent at the time of the     screening history and physical. They will be told that participation is voluntary, they may     decline or withdraw at will at any time, and all results will be held strictly confidential.   "
121096|NCT01700881|"     The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a     low-fat, vegan diet improves pain and other subjective symptoms more effectively than a     control supplement or a placebo. The principal measure is pain as measured by Visual Analog     Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,     respectively. The study duration is 36 weeks.      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified     as triggers improves mood, using the Center for Epidemiologic Studies Depression     Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).   "
121097|NCT01700868|"     This study aims to test hypotheses that are potentially important to diabetes management,     with practical implications for reducing the medical, personal, and economic costs of the     disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are     significantly greater than those achievable with current diet recommendations, reductions in     medication use among many intervention-group participants, beneficial changes in body weight     and serum lipid concentrations, and a demonstration of the acceptability of the intervention     diet. Progress toward these goals could refine dietary guidance for individuals with     diabetes, increase treatment expectations, and reduce the massive burden the disease     currently imposes.      The study further attempts to translate a dietary intervention studied in a clinical research     setting to a medical practice. This will contribute to developing a model for diabetes care     that can be used widely.   "
121098|NCT01700855|"     The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in     patients undergoing selective nasal sinus surgery and mammaplasty.   "
121099|NCT01700842|"     Approximately 3,000 of clinically significant isolates of different species from respective     respective sources in geographically distinct Russian cities will be collected and tested on     ceftaroline and other antimicrobials.   "
121100|NCT01700829|"     This study is designed to compare the effectiveness of two medications, Ketamine and     Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.      The first drug, Ketamine, is an experimental antidepressant that early studies have shown may     quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the     comparison drug, is not thought to reduce depression or suicidal thoughts.   "
121101|NCT01700816|"     The purpose of this study is to find out if using bright light sessions during bone marrow     transplant can prevent people from developing confusion also known as delirium.   "
121102|NCT01700803|"     The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by     Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section     wound infections & compare side effects of both agents.   "
121103|NCT01700790|"     The object of this study is to evaluate the pharmacokinetic interactions, short term safety     and efficacy of standard dose lopinavir/ritonavir 200mg/50 (two tablets twice daily) given     with ritonavir 100 mg three tablets twice daily given in combination with rifampin in     HIV-infected persons with tuberculosis   "
121106|NCT01699711|"     Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate     dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta     precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The     clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a     therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease)     like progression.   "
121107|NCT01699698|"     Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis     to screen UICC stage II pancreatic ductal adenocarcinoma patients.   "
121109|NCT01700738|"     MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with     conventional treatment of obesity.      SECONDARY OBJECTIVES        -  Compare the effects of the placement of a gastric band with conventional treatment of          obesity on quality of life, body composition and parameters of the metabolic syndrome.        -  Identify predictors of good answer to the ring to determine the best future          indications.        -  Study of the gastric tolerance.      INCLUSION CRITERIA        1. Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is          greater than IMCZ-score > 4 DP> 8 kg        2. Obesity common non-syndromic.        3. Medical decision of surgical placement of laparoscopic gastric banding.        4. Adolescent and family who understand and accept the need for medical and surgical follow          long term.        5. Adolescent and family who fully understood the oral and written information explaining          the study and the need for prolonged follow-up.        6. Obtention of oral and written consent of the adolescent and the parents.        7. Parents and adolescents affiliated with the social security system.      NONINCLUSION CRITERIA        1. Intellectual Deficit.        2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding.        3. Obesity with severe binge eating.        4. Pregnancy or wishes of pregnancy in the following year.        5. Non accession adolescent and / or family in the process of medical care before          inclusion.        6. Predictable post surgical monitoring difficulties.        7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.        8. Participation in a clinical study evaluating a treatment during the 2 years of the          study.      EXCLUSION CRITERIA        1. Anesthetic contre indication for placement of a gastric laparoscopic.        2. IMC> 50 kg/m2 the day of inclusion.      STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient     and his family. Patients will then be enrolled and randomized. Patients in group A (surgery     group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in     group B start conventional monitoring dietary medical and physical. For both groups follow-up     visits will occur every 3 months for 2 years.   "
121110|NCT01700725|"     The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are     effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with     Gulf War Illness.   "
121111|NCT01700712|"     The increasing interest in probiotic lactobacilli in health maintenance has raised the     question of potential risks. One possible side effect could be an increased acidogenicity in     dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli     on plaque lactic acid (LA) production in vitro and in vivo.      Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM     17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over     trial. The concentration of LA in supragingival plaque samples was determined at baseline and     after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated     with chair-side methods.   "
121112|NCT01700699|"     -  Background: BRAFV600E is the most frequent oncogene in differentiated thyroid cancer          (DTC) occurring in about 50% of cases. Clinical trials with tyrosine kinase inhibitors          (TKI) with specific activity against BRAF in metastatic radioiodine-resistant DTC          (MRR-DTC) are ongoing. Very recently it has been demonstrated that DTC often consists of          a mixture of tumor cells with wild-type and mutant BRAF. The subclonal occurrence of          BRAFV600E in MRR-DTC could disable the therapy with BRAF targeted TKI and be responsible          of the frequent defeats of this treatment. A therapeutic strategy based upon BRAF          inhibitors in tumors bearing subclonal BRAFV600E could be initially successful hitting          the tumor cells expressing the oncogene, and after the initial tumor growth arrest          and/or shrinkage, the oncogene negative cells insensitive or less sensitive to the          treatment, could restart the growth of the tumor causing the progression of the disease          and the escape from the clinical response.        -  Aims: To determine the impact of subclonal BRAFV600E on the efficacy of BRAF inhibitors          in the treatment of MRR-DTC.        -  Study design: Primary tumor tissues will be analyzed for the presence of BRAFV600E by          pyrosequencing or other quantitative assay. If available, synchronous metastases and          post-therapy metachronous metastases will be analyzed as well. The clinical response          will be determined according to RECIST, and the association with the percentage of          BRAFV600E alleles will be evaluated. Attention will be paid to the possible difference          of BRAFwild-type/BRAFV600E ratio between primary tumors and synchronous metastases,          primary tumors and post-therapy metachronous metastases, and between responsive and          resistant synchronous tumor lesions.   "
121113|NCT01700686|"     The overall purpose is to explore the link between the gut and the bones by investigating     meal stimulated changes in the blood level of a number of hormones and markers related to     intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric     bypass). The hormones will be measured in blood samples taken before and after surgery. The     results are compared with changes in body weight and body composition as measured by DEXA     scanning.   "
121114|NCT01700673|"     To determine the impact of maintenance therapy in patients with MDS/AML in remission.   "
121115|NCT01700660|"     Major liver surgery often requires the surgeon to temporarily halt the afferent blood flow in     order to prevent excessive blood loss. However, this predisposes the liver to a detrimental     inflammatory response once the circulation is restored. Altogether, the effects that result     from this temporary withdrawal of blood are known as ischemia and reperfusion (I/R) injury,     and the extent to which this occurs determines the functional outcome of the liver after     surgery.      Recently, it has become clear that (over)activation of the immune system forms the mainstay     of I/R injury in the liver. More importantly, it has been shown in animal models that     self-antigens, which are normal cellular constituents that become immunogenic mediators     following their release from dying cells, are involved in the earliest stages of I/R injury     of the liver. Clinical data on the release self-antigens in I/R injury are however scarce to     date. Therefore, the aim of this study is to investigate the release of self-antigens in     patients that undergo a major liver resection with or without withdrawal of the liver's blood     flow. Also, the results will be correlated to genes involved in the inflammatory response as     well as clinical parameters for liver damage and function.   "
121151|NCT01700192|"     The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the     treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in     children and adults.      The primary hypothesis of this study is that administration of MK-8237, compared to placebo,     results in significant reduction in the average total combined rhinitis score (TCRS).   "
121122|NCT01700569|"     O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by     Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al     published regimen. In preclinical models, it has been demonstrated that MGMT methylation     (which is silencing the DNA repair process) is achievable by folic acid. About half of the     patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer     prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic     acid in combination with temozolomide and radiotherapy of operated GBM.   "
121123|NCT01700556|"     The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease     patients through the integration of services and the use of new TECHnologies in order to also     improving the quality of life of their family caregivers.   "
121266|NCT01698658|"     This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with     breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may     help find and diagnose breast cancer.   "
121116|NCT01700647|"     It is possible to test a sample of breath from a patient, run it through a machine, and find     out certain diseases in the patient without needing to do Xrays. It is sort of like     abreathalyser.In the future it is hoped this type of testing will be common, and allow     certain conditions to be picked up early. One of these conditions is Cancer of the Larynx     (voice box). It is not in wide use yet however a study has shown it is very effective in     detecting Larynx cancer.      This breath test has detected cancers at a stage when they CAN be seen on Xrays or looking in     with cameras. However the larger the cancer ultimately the worse it is for the patient. It     would therefore be much better to have the breath test find patients with cancers at a much     smaller size. It is interesting that the cancers which the breath test HAVE found all have     the same breath test signal, regardless of size. This means even smaller cancers may have the     same signal. These small cancers are only 1-2 mm thick, and when found at this size almost     all can be cured. We want to find a group of patients who have these early cancers and     compare it to breath test result in patients who have large obvious cancers. These patients     will be compared to other patients who have are negative for larynx cancer who also have a     breath test. We want to prove that their breath test will be negative.      You have been referred either because you have symptoms (such as cough or hoarse voice) and     need a scope to look into the airways, OR your specialist has identified a spot on the larynx     which needs a biopsy (sample) and then possible treatment, The spot may or may not be cancer-     that is why the biopsy is needed. After that the correct treatment would be considered     depending on the result, that is, whether it is a cancer or not. If possible we would like to     take a test of your breath before the biopsy. Alternatively we can take a breath test 2 weeks     after a biopsy.      In summary this study is trying to show whether the breath test is the same in patients who     have large cancers as patients with small cancers invisible on XRay and only found with     careful magnification by scopes looking in. If we can show these findings it will demonstrate     great potential for the breath test to find many more cancers which are truly curable.   "
121117|NCT01700634|"     The aim of this project is to investigate fMRI ability to identify pain central sensitization     in chronic knee OA. Patients with high and low central sensitization and healthy control     subjects will be included. Central sensitization will be clinically defined based on the     evidence of regional spread of pain (spreading sensitization) and increased pain response to     repeated stimulation (temporal summation). Operatively, a patient will be assigned to high     sensitization group when showing (i) clinical evidence of pain or altered sensations spread     beyond the knee joint by manual palpation, (ii) a minimum of 3 anatomical sites around the     knee showing a pressure pain threshold below 4 kg/cm2 (tender points), (iii) pain score of 4     points or more in a 11-point scale during 4 kg/cm2 pressure stimulation on the     anterior/medial surface of the tibial bone (the site selected for the fMRI experiment) and     (iv) increase of at least 1 point in a 11-point scale after 10 repeated pressure stimulation     on the tenderest point around the knee.      A three-step strategy is proposed to characterize the phenomenon by assessing (i) brain     response to direct pressure stimulation on the painful knee, which will reflect the     combination of peripheral and central sensitization; (ii) brain response to pressure     stimulation on a non-arthritic hyperalgesic area (i.e., the anterior surface of the tibia),     which will mostly reflect central sensitization mediated at the spinal cord level, and (iii)     brain response to moderately painful heat stimulation on a healthy skin area (i.e., volar     forearm), which will reflect central sensitization occurring in the brain and involving the     highest-level pain modulatory mechanisms. An additional evaluation is proposed using     resting-state fMRI to assess potential alterations in baseline brain functional organization.   "
121118|NCT01700621|"     The investigators aim to establish the non-inferiority of concomitant administration of     measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of     measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate     as defined by the percentage of children seroconverting to measles with a measles serum     antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant     administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained     when measles-rubella vaccine is given alone in children 9 months of age who have received a     primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at     least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.   "
121119|NCT01700608|"     Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC)     mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on     demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be     more efficient and cost-effective, but the timing of administration and criteria for patient     selection are still under investigation. We collected the data of lymphoma and myeloma     patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF.     The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic     recovery after chemotherapy in patients at their first or subsequent attempt, according to     the attending physician choice. The primary endpoint was the assessment of the rate of     patients who were able to collect >=2 x 10^6 CD34+/kg.   "
121131|NCT01700452|"     Early detection of lung cancer and early removal of the cancer nodules facilitates the     diagnosis and treatment. However, not all nodules are malignant. Currently the standard     method to diagnose lung cancer is to remove any suspicious nodules from the lung in a     surgical procedure.      This study is being conducted to evaluate the performance of a laboratory test to detect     changes in lung cells that might be an early indicator of lung cancer. The test uses mucus     (sputum) which is collected in a non-invasive method. This study will compare the results of     the lung biopsy with the laboratory test to determine if the test can detect cancer or the     lack of cancer.      The laboratory test will not be shared with the treating physician or the patient as the     current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be     enrolled in the study. There is one visit involved and includes the collection of a sputum     specimen by coughing into a cup. The medical records of patients who are negative for cancer     by biopsy will be reviewed for 2 years to detect any changes in diagnosis.   "
121120|NCT01700595|"     Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental     effects on functional, physical and psychological development of children. Perforator flaps     have already been shown to be reliable options for the reconstruction of contractures but     there have been no reports demonstrating the value of preexpanded perforator flaps of     dorsolateral trunk region in treatment of extensive contractures and scars of pediatric     patients. The purpose of this study is to demonstrate these techniques by a case series     formed of pediatric patients with broad scars and contractures of anterior chest wall,     axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated by     preexpanded perforator flaps are presented. By this means, clinical experience on intercostal     artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap, circumflex     scapular artery perforator (CSAP) flap and lumbar artery perforator flap was shared. Flaps as     large as 20,5x10,5 cm in size could be successfully transferred in pediatric patients. Broad     scar tissues were resurfaced with broad flaps carrying similar characteristics with the     uninjured anterior chest wall and neck skin in six of our patients. In one patient with     partial necrosis, full thickness skin graft was used for the residual defect. The mean     duration of postoperative (after flap transfer) follow-ups was 17,2 months. The preexpanded     TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options for the treatment     of scars and contractures of anterior chest wall, axilla, neck and breast in pediatric     patients.   "
121121|NCT01700582|"     The French National Cancer Institute (INCa) support a 28 hospital platforms network for     molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers     in order to speed up access of French cancer patients to targeted therapies (commercially     available or through clinical trials).      The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical and     molecular characteristics of these patients and their tumors and to assess the impact of     these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate,     progression free and overall survival).   "
121124|NCT01700543|"     This post market clinical follow-up study is designed to confirm safety and performance of     the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.      The safety of the implant will be evaluated by monitoring the frequency and incidence of all     kinds of adverse events.      The performance will be determined by analyzing the implant survival, overall pain and     functional performances (based on Constant & Murley score and ASES score), subject quality of     life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component     migration) of study subjects who received the Sidus Stem-Free Shoulder.      The Sidus Stem-Free Shoulder is not approved for use in the US.   "
121125|NCT01700530|"     Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic     syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk     factors. We also examined if statins impacted exercise response for mitochondrial content in     muscle or aerobic fitness.   "
121126|NCT01700517|"     Total knee arthroplasty (TKA) is a worldwide realized procedure, with 600.000 surgeries     performed per year in the United States, with a 673% increase estimated until 2030.     Functional and pain management improvement is expected in 90% of patients, with 85% of them     satisfied after the procedure.      Immediate postoperatory pain control is an important aspect to be considered. Patients     submitted to TKA endure pain with variations between 40-80 (according to analog visual scale     -AVS - which goes from zero to 100) during the immediate postoperatory, with slow decline in     the first 24 hours. Pain classified as severe occurs in 60% and moderated in 30% of patients     submitted to TKA during this period of time. Therefore adequate pain management allows an     earlier rehabilitation, with a higher satisfaction rate and decrease the hospitalization     period.      A multimodal control of pain can be reached by using non-steroidal anti-inflammatory, COX-2     anti-inflammatory inhibitors, peripheral nerve blocks and intra-articular anesthetics     injections and decrease use of opioids given of potential collateral effects. Peripheral     blockings are associated to the smallest rate of collateral effects and complications when     compared to the spinal anesthesia and analgesia controlled by the patients. Studies comparing     the effects of the femoral and sciatic-femoral blocking guided by ultrasonography for the     analgesia control after TKA were not found.      The objective of this article is to evaluate the effect of femoral and sciatic-femoral block     using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients     submitted to TKA, opioid consumption and complications associated to anesthesics procedures.   "
121127|NCT01700504|"     The effect of axillary lavage with a gentamicin solution before wound closure will reduce the     drainage volume and subsequently day of drainage removal.   "
121128|NCT01700491|"     Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior     to epidural analgesia in terms of the main complication of hypotension.   "
121129|NCT01700478|"     This study was done to determine if the use of a combination of preoperative rectal     misoprostol 400µg used with intraoperative perivascular vasopressin is better than     perivascular vasopressin used alone to decrease bleeding at myomectomy.   "
121130|NCT01700465|"     Machine learning techniques and algorithms originally developed for use in the field of     robotics can be applied to continuous, noninvasive physiological waveform data to discover     hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) estimate     acute blood loss volume, 2) monitor and estimate fluid resuscitation needs, 3) predict     cardiovascular collapse well ahead of any clinically significant changes in standard vital     signs, and 4) estimate intracranial pressure. We hypothesize that these same methods can be     used to monitor volume loss during hemodialysis, as well as predict intradialytic     hypotension, well before it occurs.   "
121132|NCT01700439|"     The purpose of the clinical study is to prove that the heart valve device is safe, effective,     and performs as intended.   "
121152|NCT01700179|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of     treatment with ACH-0143102 and ribavirin in GT1b, treatment-naive, HCV subjects.   "
121153|NCT01700166|"     The specific aims of this study are:        1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with          perinatal arterial ischemic stroke (AIS).        2. To determine if late functional outcome, physiologic response, and anatomic findings are          changed following hUCB infusion in children with perinatal AIS.   "
121133|NCT01700426|"     The study addresses treatment of iron deficiency, the most common nutritional deficiency that     infants and young children encounter. With the knowledge that iron deficiency may     irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are     offering free screening blood draws at Children's Hospital Colorado to older babies and     toddlers (9-24 months old). If their blood results indicate a serum ferritin of ≤ 15     micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be     invited to continue in the intervention portion of the study, where they will receive iron     supplements as well as vitamin E (or placebo) for an eight week treatment period. The     rationale for the study is to test whether addition of Vitamin E, an antioxidant and     anti-inflammatory agent, improves the treatment response to supplemental iron.   "
121183|NCT01699776|"     It is established that at a serum concentration 0.5-0.9 ng/ml digoxin is effective in     patients with heart failure, especially in the presence of atrial fibrillation (AF). It is     the claimed that ivabradine by lowering heart rate reduces symptoms and improves clinical     outcomes in patients with heart failure. The effect of ivabradine and digoxin in heart     failure was compared.      Patients 22 patients with ischemic heart failure, AF, and diastolic dysfunction with     preserved left ventricular systolic function were treated with digoxin and ivabradine for 3     months, according to a randomization cross-over design.      Collected data Medical history, physical examination, laboratory (including proBNP and serum     digoxin concentrations), ECG, 6-minute walk test, and echocardiographic data (LVEF, LAVi,     e/e1 ratio).   "
121134|NCT01700413|"     While several studies have been reported with increasing doses of daunorubicin in the first     line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with     idarubicin as initial treatment of AML.      As idarubicin is the most common treatment used for AML, it is needed to find the optimal     dose for the combination of idarubicin, cytarabine and G_CSF, to explore if this combination     improves the outcomes of current treatments for AML.      The aim of this dose-finding study is to find the optimal dose for the combination of     idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and     improve survival of patients with primary acute myeloid leukemia. This could be a significant     advance in a field where treatment outcomes have stabilized in the last 15 years. This study     will be the basis for further prospective, randomized, multicenter trial comparing idarubicin     maximum tolerated dose, compared to standard treatment with idarubicin and cytarabine,     including raising both arms in G-CSF. The dose of 12 mg/m2 will be administered as control     arm in this future randomized study, which will investigate the benefit of enhanced dose     identified as optimal in this phase II pilot study.   "
121135|NCT01700400|"     The purpose of this study is to determine whether the investigational study drug everolimus     may be used to increase the effectiveness of chemotherapy treatment for patients with     advanced lung cancer.   "
121136|NCT01700387|"     The purpose of this study is to evaluate sustained tolerability, quality of life, and change     in cognitive efficiency following treatment with OnabotulinumtoxinA and daily topiramate vs.     OnabotulinumtoxinA and daily placebo (Group A vs. Group B).   "
121137|NCT01700374|"     The purpose of this study is to determine how difficult life-events that women experienced     during their childhood might affect their babies.      Women who are asked to participate in this study will fill out forms about their physical and     mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses     measured and have their baby's development and stress responses assessed.   "
121138|NCT01700361|"     This study will examine whether measurement of pelvic floor muscle sEMG activity is     responsive to explicit sexual stimuli, and whether it correlates with self-reports of sexual     arousal in healthy women. Participants' vaginal, labial and anal sEMG readings will be     monitored during exposure to neutral, erotic and anxiety-provoking films. Participants will     also be required to provide subjective ratings of sexual arousal before and after each film.     If pelvic floor sEMG is validated as a psychophysiological measure, these findings may have     important clinical and research implications by providing a greater understanding of the     mechanisms involved in sexual arousal and for providing a relatively easy method of assessing     sexual arousal in a clinical or research setting.   "
121139|NCT01700348|"     In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual     Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and     who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No     Intervention group and will be given no test products or instruction other than to change     none of their typical at home oral hygiene habits.      The aim of this study is to investigate how an AF and MTB oral hygiene intervention will     affect a population of irregular flossers using the residual protein concentration method as     an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the     Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices   "
121140|NCT01700335|"     The purpose of this study is to investigate tolerability when SyB L-1101 is administered     intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to     determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the     recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be     investigated.   "
121148|NCT01700231|"     Introduction Liver resection is considered the only curative treatment option for mCRC     patients without extrahepatic disease and is accepted practice. Despite substantial     improvements in surgical techniques, postoperative morbidity and mortality remain an     important concern after major resections. Complications of liver resection, although rare,     include liver failure and acute kidney injury as indicated by oliguria and increased serum     creatinine. The underlying pathophysiological pathways of post-operative renal alteration     following liver resection is an increase in portal venous pressure, based on observations in     animal models or small cohorts. The corpus of data is derived from patients with liver     cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot     distinguish between metabolic changes, portal hypertension and impaired liver function in the     elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent     model to evaluate the impact of portal hypertension on the kidney despite stable liver     function.      The most significant factor determining morbidity and mortality following hepatectomy is the     ability of the remnant liver to regenerate. In this context, several growth factors were     shown to regulate the highly orchestrated process of liver regeneration (LR).      Hypothesis The investigators will therefore test the hypothesis that liver resection leads to     a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal     impairment, correlating with the quantity of resected liver.      Furthermore, the investigators will examine the relationship between postoperative liver     regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based     on the preclinical data the investigators hypothesize that a circulating growth factor levels     will be associated with delayed liver regeneration, an increased incidence of postoperative     liver dysfunction and concomitant worse clinical outcome.   "
121141|NCT01700322|"     Endothelial dysfunction is an important predictor - and a determinant - of adverse clinical     outcome. Endothelial function is impaired by coronary artery stenting, a stud from our group     has shown that it can be improved by platelet inhibition using clopidogrel. However,     clopidogrel unresponsiveness is a known problem, and it has been show that the endothelial     effects of clopidogrel tend to wane upon prolonged treatment. Whether a more effective     anti-platelet therapy is able to prevent/improve not only thrombotic events but also     endothelial dysfunction, with potential positive impact on clinical outcome in patients     undergoing coronary artery stenting, is an important hypothesis that needs to be further     investigated. To date, evidence regarding ancillary (non-platelet-dependent) effects of     antiaggregant drugs is very limited. For instance, while their antiplatelet effects, and     their beneficial effects in patients with acute coronary syndromes, have been clearly     demonstrated in multicentric trials, it remains to be shown whether these drugs also protect     endothelial function. Interestingly, some authors suggest that the mortality benefit observed     in the PLATO study is at least in part independent of direct antiplatelet effects. No study,     to date, has tested the effects of prasugrel and/or ticagrelor on endothelial function. With     the present trial, the investigators plan to test the effect of clopidogrel, prasugrel and     ticagrelor on endothelial function before and up to 4 weeks after coronary artery stenting.     This study will provide important pathophysiologic insight on the relationship between     platelet aggregation and endothelial function, two parameters that have been shown to     influence patients' prognosis.   "
121142|NCT01700309|"     The prevalence of overweight and obesity is increasing throughout the world. Obesity is seen     as one of the most important public health threats because of the significant impact of     chronic conditions associated with obesity. Obesity during adolescence is a strong precursor     of obesity and related morbidity in adulthood.      Interventions aimed directly at reducing weight or preventing increase in weight shows     limited results on long term effects and it is shown that increase in activity has more     impact on health outcome than on weight-loss. Further, weight-loss does not seem to be an     appropriate measure of therapeutic interventions for growing children. The hypothesis of this     study is that focusing on increasing meaningful physical activity through individual tailored     counselling will have positive effects on the adolescents' fitness (health) and quality of     life. Thus, the overall purpose of the study is to examine the extent to which a web-based     intervention influences physical activity, fitness and quality of life in over-weight and     obese adolescents Further, the aim is to explore and describe how adolescents experience     being over-weight and obese, what they perceive as meaningful physical activity and finally     how adolescents experience lifestyle changes as demanded in the intervention study.   "
121143|NCT01700296|"     Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is like     any other with a chronic illness not only affected by the physical discomfort the illness     gives. For COPD patients that is: accelerated loss of lung function, conditioning and     increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months later.      Patients are also characterized by various psychological factors such as reduced quality of     life, depression, etc.      Therefore, everywhere in the country newly diagnosed COPD patients are offered rehabilitation     in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a week with physical     exercise, smoking cessation, medication, nutrition education and psychosocial support and     patient education based on the National Health Service and international recommendations.      In the literature, the effect of rehabilitation on quality of life was measured using a     questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function has     been measured using a walk test, but there are no studies which look at the effect on     inflammation lungs.      It is important for COPD patients is to prevent exacerbations of the disease, which sometimes     requires hospitalization and sometimes treated by their own doctor. It has been proven that     inflammation in the lungs is associated with disease severity and exacerbation frequency, and     therefore we would like to investigate whether both rehabilitation, close monitoring of     patients with time in the pulmonary clinic every 3 months, and instruction in     self-administration of medication (antibiotics and corticosteroids) have an effect on     especially inflammation in the lungs, number of exacerbations, mortality, lung function and     walking capacity.   "
121144|NCT01700283|"     The aims of this four-year study are to        1. Explore exercise behavior, exercise barriers, and identify the significant factors for          exercise behavior in colorectal cancer survivors.        2. Explore the relationships among fatigue, muscle strength, and metabolomics and further          examine the possible biomarkers from muscle strength and metabolomics for fatigue.        3. Develop a clinical guidelines of home-based fatigue management and exercise program and          test its effect on decreasing fatigue for patients with colorectal cancer after surgery          in Taiwan.   "
121145|NCT01700270|"     This is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (DDI)     study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in     patients with advanced solid tumors, excluding breast cancer. The purpose of this study is to     evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib when     administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The study will     consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase. The DDI     test will be conducted in the PK phase. The DDI test will assess the steady state PK profile     of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor, fluvoxamine     (AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase patients may     continue to receive treatment with TKI258 until disease progression (assessed by RECIST 1.1),     unacceptable toxicity, death or discontinuation from the study treatment for any other     reason.   "
121146|NCT01700257|"     Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is     asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already     have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has     recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer     deaths are not prevented with LDCT screening alone.   "
121147|NCT01700244|"     An evaluation of a safety and performance of a new cardiac pacemaker   "
121149|NCT01700218|"     The purpose of the study is to test a new medical device for optimizing treatment of heart     failure and compare its effect on outcome of patients with a recent hospitalization for     worsening heart failure   "
121184|NCT01699763|"     The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring     System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other     companies. All meter BG results were compared with plasma results obtained with a reference     laboratory glucose method (YSI Glucose Analyzer).   "
121154|NCT01700153|"     Cerebral Palsy (CP) is a major cause of impairments in child population. This disease     justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised     by robotics.      Our team has developed a robot designed to rehabilitate the child's upper limb. This robot     allows the patient to perform active, passive, or assisted exercises.      This therapy is designed to promote motor development in children with CP. Its finality is to     improve patients' quality of life and participation.      Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP     but none RCT has been done.      Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in     children with cerebral palsy by evaluating the 3 fields of the ICF (International     Classification of Functioning, Disability and Health) and performing a prospective randomized     controlled single blind trial. Therefore, all patients will benefit from a classical     rehabilitation as a basis. Furthermore, patients of the control and experimental groups will     receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.   "
121155|NCT01700140|"     The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea     and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer     patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.   "
121156|NCT01700127|"     This will be a randomized study with the primary objective of assessing the impact of     withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.      Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14     weeks. The subjects will be randomized into one of the two study arms. In one of the group     caregivers will be advised to breastfeed immediately prior to and after each dose of the     vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30     minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and     Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The     enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.   "
121157|NCT01700114|"     The purpose of this study is to collect data to describe the real-world use and safety and     effectiveness of MelaFind® in a post-approval clinical setting.   "
121158|NCT01700101|"     We have added objectives 4-6 to our updated study:      Study Objective 1: To determine whether the distribution of MelaFind scores is different for     different patients with multiple nevi, and whether such distributions can be utilized to     identify signature lesions for a given patient.      Study Objective 2: To investigate whether distributions of quantitative ABCD parameters     differ among patients and whether these qABCD parameters identify signature lesions.      Study Objective 3: To determine the feasibility of defining and using relative thresholds to     improve the specificity of MelaFind without sacrificing its high sensitivity.      Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for     different patient and lesion characteristics.      Study Objective 5: To identify patient and lesion characteristics that result in the highest     variability of MelaFind scores for a given lesion.      Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual     threshold for lesions to be considered for biopsy to rule out melanoma on patients with     multiple nevi.   "
121159|NCT01700088|"     At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via     face mask in patient having lung resection surgery. After then if the patient is fine, we'll     replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen     mask can be replace by nasal cannular without any hypoxia.   "
121160|NCT01700075|"     Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical     properties of lipid tissues at various localization with subsequent development of concept of     treatment and prevention.   "
121161|NCT01700062|"     aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or     standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer     undergoing surgery   "
121162|NCT01700049|"     The purpose of this study is to investigate the safety and effectiveness of oral vismodegib     therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC).     The term 'histologic subtype' refers to how the cells and tumor tissue looks under the     microscope. Three different 'histologic subtypes' of basal cell skin cancer     (infiltrative/morpheaform, nodular and superficial) will be examined in this study.   "
121163|NCT01700036|"     This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha     1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor [Human]) for the     treatment of steroid refractory GVHD.      For bone marrow transplant patients, the most common, serious complication is Graft vs Host     Disease (GVHD), which at its most severe is a life-threatening, complication and a     significant cause of treatment related death, following stem cell transplantation. GVHD is a     major obstacle to the overall success of transplant treatment, a strategy that would     otherwise provide the possibility of a cure for patients with blood cancers or severe blood     disorders. GVHD primarily affects the skin, gut, and liver of the recipient, and involves the     interaction of the recipient's (the host's) cells and tissues with the donor's immune system     cells that see the host tissues as foreign, and attack the host's cells resulting in tissue     and organ damage.      The severity of acute GvHD ranges from mild to severe, and for patients who don't respond to     steroid therapy, the complication is nearly always fatal, either from organ damage or     opportunistic infection as a consequence of high dose, steroid treatments.      There is currently no known effective therapy for patients with acute graft vs host disease     that's refractory (nonresponsive) to steroid therapy. As stated earlier,the overwhelming     majority of these patients may ultimately die from infection. The incidence of acute GvHD     that requires intervention, is higher for unrelated donor transplants, the most common     treatment option available, and therefore, these patients are at higher risk for treatment     related complications from GVHD. Approximately 20,000 unrelated donor transplants are     performed each year. The magnitude of this problem then is significant for patients who     otherwise might be cured of their blood cancer or disease.   "
121164|NCT01700023|"     The purpose of the study is two-fold:        1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute          heart failure with leg-edema.        2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure          measurement in patients hospitalized for acute heart failure.   "
121185|NCT01699750|"     The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and     visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when     used in conjunction with two contact lens care systems.   "
121165|NCT01700010|"     This study will involve subjects who have advanced urothelial cancer who are platinum     refractory (platinum based chemotherapies that are not effective in treating the cancer), and     who are over-expressing EGFR and/or HER2, or do not over-express EGFR and HER2. Genetic     expression is a process that takes inherited information in genes (like DNA sequence), and     from that information makes a specific functional product (sometimes called a gene product)     such as RNA (ribonucleic acid) or protein. Normal tissue cells have a particular genetic     expression, which changes when they turn into cancer. EGFR and HER2 are involved in the     process by which normal cells are transformed into cancer cells.      The main purpose of the study is to look at the proportion of subjects, who over-express EGFR     and/or HER2, who do not progress (cancer gets worse) after 16 weeks of study treatment with     daily lapatinib and weekly paclitaxel. The study will also look at the safety and     effectiveness of this therapy in all subjects.      Another part of this study will look at blood and tissue samples. Blood samples will be     collected to see how many cells express EGFR and HER2 before study treatment and at the time     the cancer gets worse. Tumor tissue will be analyzed to look at the expression of certain     genes in advanced urothelial cancer. Some gene expression tests can reveal how cancer cells     are different from normal cells and the results might lead to more accurate diagnosis and     treatment.   "
121166|NCT01699997|"     Background: A large body of research has shown that Oxytocin (OXT) is an important prosocial     peptide and there is also initial evidence that the central OXT system is altered in several     mental disorders that are characterized by severe social disturbances and deficits, such as     anxiety disorders with prominent social dysfunction (e.g., schizophrenia), mood disorders and     borderline personality disorder. OXT may reduce psychotic symptoms and may diminish certain     social cognition deficits that are not improved by current antipsychotic medications.      Aims: The project has two main aims, listed below:        1. To assess the efficacy of intranasal OXT in reducing negative symptoms in patients with          schizophrenia in association with second-generation antipsychotics (SGA);        2. To use an Emotional Priming Paradigm task to assess pre- and post-treatment change in          the patients general cognitive and emotional status.      Study Design: Randomized, double-blind, placebo-controlled, cross over design. Materials and     methods: Patients involved in the study will be recruited in six centres in the north of     Italy. Each subject (aged 18-45, with a duration of the disorder no longer than 10 years)     will be enrolled after a screening phase. 80 patients will be randomly assigned to either 40     IU OXT once daily or vehicle placebo, in addition to their pre-study antipsychotic medication     regimen: all reasonable attempts maintain the same SGA dosages throughout the study will be     made. The study ratio is 1:1. The total study duration for each individual subject will be     approximately 8 months, which includes an up to 7-day screening period, a baseline     randomization visit, and a four month long cross-over treatment period. Subjects will be     trained by researchers about the self-administration of intranasal OXT. A trustworthy     caregiver will be trained as well. Each patient will receive every morning a SMS text message     on his mobile phone as a reminder for OXT administration.      Before starting the treatment, all patients will be assessed with standardized assessment     instruments and will undergo an in depth neuropsychological assessment; additional     evaluations, including safety evaluations, will be performed at 4 and 8 month follow-ups.      The primary outcome measure will be the negative score in the Positive and Negative Syndrome     Scale (PANSS) performed at 2,4,6 and 8 months since the start of the treatment.   "
121167|NCT01699984|"     This prospective observational cohort study aims at studying functional and clinical outcomes     of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order     in Northern Italy during an index period of 4 months. Other areas assessed include variables     that help or hinder the discharge of patients with sufficient residential autonomy and the     predictive ability of clinicians compared with the evaluation of selective indicators of     outcome (clinical and instrumental).      Patients are followed from the first day of hospitalization until discharge or up to 3 months     and 1 day after the date of admission (long-term care patients).      At admission a Patient Form including social, demographic and clinical informations and a     series of standardized assessment tools is completed with the help of clinicians, nurses and     caregivers (when available).      For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is     performed and adverse events occurred during hospitalization are monitored, as well as the     predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at     discharge (or after 3 months for long-term care patients) and at 6 months follow-up of with     a standardized telephone interview to assess clinical and functional status and possible     changes in the residential status of the patient.   "
121168|NCT01699971|"     The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain     postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life,     recovery from surgery and frequency of recurrencies in the three groups   "
121169|NCT01699958|"     The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect     of the healthy Living Study, a brief outpatient problem-solving intervention to promote     healthy eating and activity habits in adolescents.   "
121170|NCT01699945|"     The goal of this study is to generate unique information to guide improvements on     interventions to reduce maternal and newborn mortality as well as prevent stillbirths.      The objective of this study is to determine the burden, timing, and causes of maternal     deaths, stillbirths and neonatal deaths.      This will be an observational study where data will be collected retrospectively in the     context of the ongoing study in Haryana, India.      Women of reproductive age living in the study area have already been enumerated for the     parent studies. Active surveillance is being conducted for identifying pregnancies and deaths     among women of reproductive age in the population through 3 monthly home visitations.      Verbal autopsies will be conducted for all deaths of women in the reproductive age, including     those who died in pregnancy, childbirth and up to 42-60 days after childbirth. Verbal autopsy     interviews will also be conducted for all stillbirths.   "
121171|NCT01699932|"     Primary Objective:      -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of     HbA1c reduction, during 24-week treatment period in patients with inadequately controlled     type 2 diabetes mellitus.      Secondary Objective:      To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:        -  Percentage of patients reaching HbA1c <7%        -  Percentage of patients reaching HbA1c <6.5%.        -  Fasting Plasma Glucose (FPG)        -  Safety and tolerability   "
121172|NCT01699919|"     The primary objectives of this study are to analyse the effect of perioperative systemic     infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and     perioperative levels of inflammatory mediators in patients undergoing elective open abdominal     surgeries.      The secondary parameters which will be observed during the study are the time to passage of     flatus and stools postoperatively.   "
121199|NCT01699529|"     This is a prospective, single-arm, non-randomized and open label feasibility study. The study     is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal     denervation in patients with uncontrolled hypertension.   "
121173|NCT01699906|"     Breast cancer is one of the most frequently seen cancers in the United States. It occurs at     all ages but is particularly common in post menopausal women. Obesity increases the risk of     breast cancer and colon cancer among others, and when cancer develops increases the risk of     spread and death. Inflammation of fat tissue, the coronary blood vessels and the liver are     also seen with obesity. Animal experiments have shown the inflammation in fat tissue     increases the production of estrogen. Thus, reducing inflammation in fat tissue might lower     estrogen levels and reduce the risk of breast cancer in obese women as well as the spread of     other cancers in the body. Weight reduction in obesity has been shown in epidemiology studies     to lower the risk of colon cancer and in obese women to lower the risk of breast cancer.     However, how that occurs and how much weight loss is necessary is not known. In mice, calorie     restriction in obese animals has been shown to reduce inflammation in fat tissue and the     breast. In other studies, calorie reduction has been shown to lower the development of     cancer. In addition, we really do not know what starts the whole inflammation process. One     good possibility is that immune factors that tend to reduce inflammation are less in obesity.     We have shown this in the colon and this also has been suggested as occurring in fat stores.   "
121174|NCT01699893|"     The purpose of this study is to assess the determinants of immunologic variance within the     general healthy population.   "
121175|NCT01699880|"     Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU)     with significant complications and morbidity. Patient desaturation is one of the most common     complications that may lead to cardiac arrest despite pre-intubation oxygenation.     Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can     be cumbersome to implement in the context of urgent intubation and more importantly it does     not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a     technique that has been shown to improve patient oxygenation in the context of acute     hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the     setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study     is to compare pre- and per-intubation (during intubation) oxygenation with either a     conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow     nasal cannula oxygen therapy (new practice to be implemented in our ICU).   "
121176|NCT01699867|"     This multi-center, prospective, open label study analyzed specimens from fifty subjects at     two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in     accordance with the inclusion and exclusion criteria. The study period per subject was the     time it took to assess the ex vivo breast tissue sample using the study device. Image review     was conducted after surgery and compared to the margin status findings in the post-operative     pathology report.   "
121177|NCT01699854|"     In the present study the investigators intend to investigate analgesic and sensory effects of     a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory     abnormalities in the skin.   "
121178|NCT01699841|"     The purpose of this study is to understand how breast milk may protect infants from infection     and promote favorable immunological, growth and development outcomes. By following mothers     and their infants, we will evaluate the important interactions between infant immune     responses and infectious disease events in relation to breast milk composition and feeding     patterns. Our aim is to identify a set of predictive factors corresponding to healthy early     infant growth and development in this setting in Northern Tanzania.   "
121179|NCT01699828|"     The objective of the present study is to use positron emission tomography brain imaging to     investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin     partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that     clinically relevant doses of buspirone will occupy the D3 receptor.   "
121180|NCT01699815|"     The purpose of the study is to examine the effects of timing of administration of intravenous     (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative     pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled     total hip replacement under general anesthesia will be randomized into one of two arms: 1)     the pre-closure group will receive the first dose administered upon onset of skin closure, 2)     the preemptive group will receive the first dose administered within 60 minutes prior to     incision. Both groups will receive subsequent doses every 6 hours x 24 hours.   "
121181|NCT01699802|"     The purpose is to investigate how the adsorptive capacity of the active carbon filter to     carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled     anaesthetic agent.      The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of     adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon     dioxide.   "
121182|NCT01699789|"     CPIC is a community initiative and research study funded by the NIH. CPIC was developed and     is being run by community and academic partners in Los Angeles underserved communities of     color. CPIC compares two ways of supporting diverse health and social programs in     under-resourced communities to improve their services to depressed clients. One approach is     time-limited expert technical assistance coupled with culturally-competent community outreach     to individual programs, on how to use quality improvement toolkits for depression that have     already been proven to be effective or helpful in primary care settings, but adapted for this     study for use in diverse community-based programs in underserved communities. The other     approach brings different types of agencies and members in a community together in a 4 to     6-month planning process, to fit the same depression quality improvement programs to the     needs and strengths of the community and to develop a network of programs serving the     community to support clients with depression together. The study is designed to determine the     added value of community engagement and planning over and above what might be offered through     a community-oriented, disease management company. Both intervention models are based on the     same quality improvement toolkits that support team leadership, care management, Cognitive     Behavioral Therapy, medication management, and patient education and activation.     Investigators hypothesized that the community engagement approach would increase agency and     clinician participation in evidence-based trainings and improve client mental health-related     quality of life. In addition, during the design phase, community participants prioritized     adding as outcomes indicators of social determinants of mental health, including physical     functioning, risk factors for homelessness and employment. Investigators hypothesized by     activating community agencies that can address health and social services needs to engage     depressed clients, these outcomes would also be improved more in the collaboration condition.     Investigators also hypothesized that the collaboration approach would increase use of     services.   "
121208|NCT01699412|"     The purpose of this study is to perform a randomized, double-blind, clinical trial comparing     the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of     chronic graft-versus-host disease.   "
121321|NCT01697943|"     The purpose of this study is to find out more about differences of the quality of life in     patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction.     To find a better reconstruction for patients who received total gastrectomy.   "
121188|NCT01699672|"     The main aim of the current study is to investigate whether the addition of a     standardized,group-based educational program to the information provided by health care     personnel improves cancer patients' knowledge level about their disease, planned treatment     and common side-effects of the treatment.      Secondary aims are to investigate if the addition of the educational program increases the     likelihood of completing treatment as planned, reduces level of anxiety, reduces the     frequency of serious side effects, increases patient reported health related quality of life,     and increases the degree of patient satisfaction with respect to how they have received the     information before, during and after treatment.   "
121189|NCT01699659|"     Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as     protocols described in the Allergy literature.   "
121190|NCT01699646|"     Hypothesis:      STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia     and reduce the number of newborns with metabolic acidosis.      Primary endpoint:      1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery     < 7.05 and standard base excess <-10.      Secondary endpoints:        1. Number of intervention (VE and caesarean section) in the two groups        2. Number of pH measurements in the two groups        3. Number of neonates admitted to the neonatal department because of suspected asphyxia in          the two groups      The aim of fetal surveillance is to identify those fetuses at risk for developing damage in     newborn to term or long term damage caused by lack of oxygen during birth process.     Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed     to be caused by lack of oxygen during birth. These can be avoided if the investigators     intervene actively in the birth before damage occurs.      CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine     contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method     of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in     CTG interpretation may therefore lead to increase in the number of deliveries with vacuum     suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity     of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis shows     indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires     repeated measurements if the abnormal heart rate pattern persists. This method is the normal     routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital.      The problem seems to be partially alleviated by using a newly developed method for fetal     surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG     (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a     portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The     technique is easy to use, since it only requires one electrode on the fetal scalp that is     placed in the same way as in ordinary CTG registration.   "
121191|NCT01699633|"     Nevirapine is the preferred nonnucleoside reverse transcriptase inhibitor (NNRTI) for     treatment of HIV in children younger than 3 years old who have tuberculosis (TB) coinfection.     However, there is very limited data on the drug-drug interactions between rifampin and     nevirapine in children of this age group. The purpose of this study is to determine the     effect of rifampin-containing anti-TB treatment on the blood levels of nevirapine in young     children with HIV and TB coinfection. Also, the study will find out whether checking the     genetic makeup of a child could help to determine the appropriate dose of nevirapine in the     setting of concomitant anti-TB treatment.   "
121192|NCT01699620|"     The study compares two different operative techniques for placement of the Cochlear Bi300     implant to be used for bone anchored hearing aid. The operative techniques to be compared are        -  Dermatome technique with soft tissue reduction        -  Linear incision with minimal or no soft tissue reduction      The hypothesis is that the operative techniques are comparable with regard to implant     stability, soft tissue healing and loss of sensibility around the implant.      To evaluate the evolution of implant stability during the early healing period after     implantation, which is the most critical period for osseointegrated implants, in particular     when early loading protocols are used.      To compare soft tissue healing around Baha implants placed according to the recommended     surgical technique with skin transplant and Baha implants without performing skin reduction.      To compare the loss of sensibility of the skin around the Baha implant (some loss of     cutaneous sensibility nerves in the transplant procedure) between the two surgical     procedures.      While the study focuses on the early healing period (3 months), long-term safety data will     also be collected after 6 months and 1-year.      The study will also evaluate the change in health status produced by the surgical     intervention.   "
121193|NCT01699607|"     A research study designed to examine amphetamine-induced dopamine release using the PET     imaging agent [11C]PHNO in tobacco smokers while currently smoking and during acute     withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and twenty healthy     nonsmokers will be recruited. Each subject will participate in 1 MRI and up to 2 [11C]PHNO     PET scans. On the study day subjects will participate in two [11C]PHNO scans (ideally, the     two PET scans will be carried out in the same day). Three hours before the second PET scan,     amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the scan will occur at 10-21     days of smoking abstinence.   "
121194|NCT01699594|"     Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The     investigators will look at whether or not exposure to allergens changes the way the airway     responds to a different stimuli (mannitol) and compare that with the known stimuli     (methacholine).   "
121195|NCT01699581|"     Nestle Impact has shown efficacy in multiple surgical trials in relation to improving     hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be     taken orally three times a day beginning on the morning following stem cell transplant and     will continue until the day of hospital discharge.   "
121196|NCT01699568|"     Objectives: To compare the stability of implant surface treated by dual acid etching     (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after     installation.      Methods: it will be a clinical study with individuals with missing teeth requiring     rehabilitation with dental implants in the maxilla and that fulfill the study inclusion     criteria. The research sites will be randomized into two groups: the control group patient's     sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant     Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque     Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability     of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell     (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive     statistics and comparative.   "
121197|NCT01699555|"     The purpose of this study is to assess the safety and tolerability of single ascending doses     of GNbAC1 in healthy male subjects.   "
121198|NCT01699542|"     The purpose of this of this study is to compare the safety and effectiveness of temporary     indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of     refractory anastomotic esophageal strictures   "
121200|NCT01699516|"     Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after     allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still     lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound     sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal     GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively     evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011.     Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group.     Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal     volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control     group. All patients were evaluated with both standard transabdominal ultrasonography (US) and     CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms.     Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of     multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of     microcirculation changes that correlated with GVHD activity. These findings were not observed     in the control group. Moreover, CEUS findings correlated with treatment response and     predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side     tool to detect and monitor intestinal GVHD.   "
121201|NCT01699503|"     The purpose of the study is to conduct a randomized clinical trial assessing the harms and     benefits of screening for dementia, compared to no screening for dementia, among 4,000 older     adults, cared for in typical, primary care practices.   "
121202|NCT01699490|"     The purpose of this study is to identify evidence-based guidelines for treating major     depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients.     To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of     adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify     the shared biological mechanisms between mood, immune and metabolism homeostasis   "
121203|NCT01699477|"     The aim of this study is to asses the efficacy and the clinical safety of the transcranial     magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec     Ltd. for functional neurosurgery. The treatments to be conducted in this study are     non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific     target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will     be used to evaluate the basic safety aspects of this new treatment technology and will serve     as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.   "
121204|NCT01699464|"     A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or     timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.   "
121205|NCT01699451|"     This study is intended to obtain clinical information and establish a repository of DNA, RNA,     peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and     related neurodegenerative motor neuron diseases, people with a family history of these     conditions, and healthy people with no family history of these disorders. The samples will be     used in future research to learn about how these disorders affect people, what causes these     conditions, and how the investigators can tell when someone has this kind of disease. Future     research may also include the generation of stem cells from stored blood cell and skin cell     samples. Participants will not be paid for taking part in this study.   "
121206|NCT01699438|"     Irritable bowel syndrome (IBS) is a condition characterised by abdominal pain or discomfort     in combination with altered bowel function (stool frequency and/or stool consistency),     currently defined by the Rome III criteria. The current IBS definition specifies that there     are no structural or biochemical abnormalities to account for the symptoms but there is     growing evidence that in at least a subset of IBS patients, a discrete immune activation     might be a key pathogenetic factor. The condition is prone to develop after a     gastroenteritis, post-infectious IBS, and increased numbers of lymphocytes, mast cells and     pro-inflammatory cytokines like Interleukin (IL)-1β, IL-6, Tumor necrosis factor (TNF)-α and     a general increase in mucosal cellularity have been reported. Despite this, the efficacy of     anti-inflammatory agents has been poorly investigated.      This will be a randomised, double blind, placebo-controlled, parallel-group, multi-centre     study that aims to include a total of 200 subjects with irritable bowel syndrome (IBS). All     subjects will be randomised to receive either 3x800 mg of mesalazine (Asacol®) or     corresponding placebo once daily for a total treatment duration of 8 weeks. Males and females     aged 18 to 70 years who already are diagnosed with IBS based on the Rome III diagnostic     criteria and with a symptom intensity of at least moderate level; defined as an IBS Severity     Scoring System (IBS-SSS) score of ≥175 at both Screening (Visit 1, Day -21±2) and Baseline     (Visit 2, Day 0) will be eligible to enter the study.      Primary aim:      To assess the effect of mesalazine (Asacol®) treatment compared to placebo on global IBS     symptoms: A treatment responder will be defined by answering the satisfactory relief of     IBS-symptoms question yes at the end of at least 4 out of of 8 treatment weeks.      Secondary aims:      To assess mesalazine (Asacol®) treatment compared to placebo regarding:        1. Levels of inflammatory mediators in the rectal mucosa (e.g. neutrophil mediators,          eosinophilic mediators, mast cell activity mediators and cytokines) measured by a new          diagnostic tool, the Mucosal Patch Technology (MPT) by means of Enzyme-Linked          Immunosorbent Assays (ELISA)        2. Effects on number of immune cells (count per high power field) and cytokine content          (immunohistochemistry) in mucosal biopsies        3. Calprotectin levels in faeces (mg/kg)        4. Individual IBS symptom parameters derived from a symptom diary and also measured by          IBS-SSS   "
121207|NCT01699425|"     The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates     comparable to those obtained by retropubic suburethral tape, becoming the first line     treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not     exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In     addition it is commonly performed under general or regional anesthesia1-3. The     single-incision mini-slings (SIMS) were developed to reduce the risk of complications by     avoiding the blind passage of the trocars through the obturator space. In addition, the use     of SIMS could enable surgeons to perform the procedure truly under local anesthesia.      Different devices for SIMS procedure are available. However, the evidence about their     efficacy is controversial4-7. The main limitation of these devices could be the predetermined     length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows     adjusting the length of the sling to each individual woman and provides a robust fixation     into the obturator membrane. Recent prospective studies on the efficacy and safety of the     sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use     SIMS in the context of research studies10.      The objective of this study is to establish if the effectiveness of the SIMS Ajust® is     non-inferior to that of a standard TOT, as well as to compare the comorbidity of both     procedures. Owing to the new appearance and fast evolution of these procedures, randomized     comparative studies with SIMS are required in order to determine its place in the treatment     of SUI.   "
121212|NCT01699360|"     The aim of this study is to evaluate the potential of endogenous cortisol and cortisone     metabolism as a biomarker for immunosuppressive agents disposition in Chinese renal     transplant recipients. If the blood concentrations of immunosuppressants can be predicted     successfully, this new probe may take place of current drug monitoring post transplantation.   "
121213|NCT01699347|"     Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head     and neck region.      The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood     tests.      The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up     will be of short term - till 30 days post injection and long term - follow-up wil be till 2     years.   "
121214|NCT01699334|"     The purpose of this study is to examine the effect of an educational video on intensity of     neck pain, disability, illness perceptions and work ability following acute whiplash trauma     caused by motor vehicle accidents.   "
121215|NCT01699321|"     Physical activity has been proven to reduce the risk of cancer. The North Carolina FITShop     research study will test the effectiveness of a program aimed at increasing physical activity     among African American men. Approximately 14 barbershops and 560 shop customers within     Orange, Durham, Chatham, Alamance, and Wake counties will be enrolled into this research     study. If FITShop is effective, we will share our results throughout North Carolina and     nationally.   "
121216|NCT01699308|"     The current protocol aims to compare the brain-functioning (fMRI & EEG) and white matter     structural integrity (DTI) of persons with mild to severe TBI with and without Growth Hormone     deficiency during cognitive tasks; and to examine changes in cognitive and motor performance,     EEG/fMRI and white matter integrity associated with growth hormone treatment for twelve     months using an open-label design in persons with GH deficiency/insufficiency following mild     to severe TBI. To meet this aim, we are in the process of screening 40 persons with mild to     severe TBI, ages 18-55, who are at least six months post injury. After screening, 10 persons     with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH injections titrated to     bring their GH levels into the normal range over the course of twelve months. Treatment will     be initiated using rhGH (Genotropin). Subjects with TBI and GHD will be assessed at baseline,     6 months, and 12 months with EEG, fMRI and DTI, and neuropsychological measures. 5 persons     with TBI who do not have GHD will be assessed at baseline and at 12 months with EEG, fMRI and     DTI, and neuropsychological measures.   "
121217|NCT01699295|"     There is currently considerable interest in both improving academic achievement (No Child     Left Behind) and reducing the rates of obesity and its associated negative health     consequences in elementary school students. Increased physical activity (PA) offers a     potential intervention to address both issues. Evidence is available which suggests an     association of PA with both academic achievement and obesity, and an association between     obesity and academic achievement.      To provide increased PA while maintaining academic instruction time, we developed a program     we call Physical Activity Across the Curriculum (PAAC) in which regular classroom teachers     were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA)     for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between     students in elementary schools that participate in academic lessons taught through MVPA     (PAAC) to students that do not (CON).   "
121218|NCT01699282|"     To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital     of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed     since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with     the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses.     The purpose of this local study, in cardiac surgery department, is to evaluate the     therapeutic impact of two methods of comprehensive education, one conventional and performed     by nurses service, less elaborate, relying solely on the book Information from The National     Security Agency of Medicines and Health Products, the other based on more detailed documents     created by a multidisciplinary group. Various studies show that the effect of therapeutic     education is observed only during the first six months and then disappears.      This study is the first French study evaluating the impact of a comprehensive education to     oral anticoagulation according to the latest recommendations of the National Security Agency     of Medicines and Health Products and the French National Health Authority.   "
121219|NCT01699269|"     This study will examine the use of a variation of standard magnetic resonance imaging (MRI)     called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter     infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor     cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less     anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is     to find if a correlation exists between GA (generalized anisotropy) and the infiltration     percentage of stereotactic peritumoral biopsies.   "
121220|NCT01699256|"     The aim of this study is to evaluate whether an enhanced strategy of implementation of the     new guideline will lower the number of patients getting referred to secondary care spine     centres compared to a normal implementation strategy.   "
121221|NCT01699243|"     Machine learning techniques and algorithms originally developed for use in the field of     robotics can be applied to continuous, noninvasive physiological waveform data to discover     hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) predict     cardiovascular collapse well ahead of any clinically significant changes in standard vital     signs, 2) monitor and estimate fluid resuscitation needs, 3) estimate acute blood loss     volume, and 4) estimate intracranial pressure. The investigators hypothesize that these same     methods can be used to predict functional hypovolemia during regional anesthesia for labor or     fetal intervention.   "
121222|NCT01699230|"     To show the existence of a atrial cardiomyocytes membranes modification in omega-3     supplemented patients with coronary atherosclerosis.   "
121224|NCT01699204|"     This experiment is designed to test the hypothesis that oxidative stress is responsible for     changes in airway responsiveness in humans exposed to diesel exhaust.   "
121267|NCT01698645|"     National multicenter, prospective, observational study in cancer patients with chronic     background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic     condition by a specialist in the treatment of cancer pain conditions.      • Study objectives include assessment of early treatment satisfaction.   "
121225|NCT01699191|"     Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria     and maintaining the integrity of the gut mucosal barrier. The beneficial effects of     probiotics have been previously studied in adult patients with IBS. Clinical studies show     that patients meeting the criteria for diagnosis for IBS have greater probability for being     affected by celiac desease if compared to controls without IBS. Since one of the causes     attributed to the onset of IBS is the modified flora gut, it is interesting to determine the     beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease     patients. The goal of the present study is to determine whether oral administration of a     probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei,     Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and     Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would     improve symptoms of adult celiac patients with IBS.   "
121226|NCT01699178|"     The purpose of this one year extension (follow-up) study is to gather additional safety data     in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III     study CLAR-09007.   "
121227|NCT01699165|"     The purpose of this study is to assess the effect of reducing exposure to allergens in     patients with hay fever by means of a nasal filter.   "
121228|NCT01699152|"     This is a multi-center, open-label, dose escalation study.   "
121229|NCT01699139|"     Supine positioning was reported to increase upper airway collapsibility, apnea frequency and     duration. Positional therapy, designed to minimize supine sleep, was reported to be     beneficial in the general sleep apnea population. As supine sleep is very common in stroke     patients, positional therapy might also have therapeutic effects. Given differences between     stroke patients with sleep apnea and the general sleep apnea patient, such as rolling     ability, body mass index and daytime sleepiness, positional therapy results in the general     population may not be applicable to the stroke patient.      The effects of positional therapy in ischemic stroke patients with OSA have not been     well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to     test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine     positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea     improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The     tolerability of positional therapy over a 3-month period in patients with ischemic stroke was     also evaluated.   "
121230|NCT01699126|"     study Hypothesis: We hypothesize that CPAP could effectively improve the endothelial     dysfunction by anti-inflammatory effect in patients of OSA,and compare to the effect of     statin.   "
121231|NCT01699113|"     The primary objectives are to find out in healthy subjects if:        -  YF476 prevents the ECL-cell hyperplasia induced by repeated doses of rabeprazole - a          proton pump inhibitor;        -  YF476 also prevents rebound hyperacidity after stopping rabeprazole; and        -  YF476 by itself causes neither ECL-cell hyperplasia after repeated doses nor rebound          hyperacidity after stopping YF476.      The secondary objectives are to:        -  assess the safety and tolerability of YF476, alone and in combination with rabeprazole;        -  compare the effects of YF476, alone and in combination with rabeprazole, on serum          gastrin and plasma CgA and SST;        -  assess if there is a pharmacokinetic interaction between YF476 and rabeprazole;        -  assess the pharmacokinetics of repeat doses of YF476 by itself; and        -  study the metabolism of YF476.   "
121232|NCT01699100|"     The purpose of this study was to determine if insoles with removable pegs could effectively     reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for     guidance of peg removal.   "
121233|NCT01699087|"     The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE     EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in     subjects undergoing photorefractive keratectomy (PRK) treatment.   "
121234|NCT01699074|"     The study is a Phase-I like double blind randomized placebo controlled crossover design     trial. The objective is to assess the dose response relationship on glycemic and vascular     effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in     individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2     Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria:     as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be     recruited for the study.   "
121235|NCT01699061|"     The purpose of this study is to determine the effects of tivantinib on the QTc interval in     patients with solid tumors   "
121236|NCT01699048|"     Minimally invasive revascularization of the left anterior descending artery followed by stent     implantation versus percutaneous coronary intervention or coronary artery bypass in patients     with multi-vessel coronary disease   "
121237|NCT01699035|"     Survey of survivor perspective on critical elements that either facilitate or inhibit return     to work after a stroke. Critical elements are queried in areas of finances, stroke     impairments, interpersonal support, therapeutic support, organization influences, work or job     specific issues and psychological issues.   "
121238|NCT01699022|"     Cyclofem® is a monthly injectable contraceptive containing 25 mg of MPA and 5 mg of estradiol     cypionate (E2C), a long acting ester of estradiol. The current study will assess the     steady-state pharmacokinetics and pharmacodynamics of MPA and E2 after administration of     Cyclofem® and will provide critical information to determine similar bioavailability of     Cyclofem to Lunelle in women residing in the USA.   "
121239|NCT01699009|"     The purpose of the study is to assess whether, in individuals with migraines, a low-fat,     vegan diet improves pain more effectively than a control supplement or a placebo. The     principal measures are pain as measured by Visual Analog Scale (VAS) and the change in     migraines frequency. The study duration is 36 weeks.This study also tests that a low fat,     plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using     the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck     Depression Inventory II (BDI-II).   "
121240|NCT01698996|"     Adult patients presenting to the emergency department with superficial cutaneous abscesses     will be randomized after incision and drainage to standard care with wound packing or no     packing to determine if there is a difference in the proportion of complications between the     two groups.   "
121241|NCT01698983|"     Gluococorticoids are commonly prescribed to treat a number of diseases including the majority     of inflammatory diseases. Despite considerable inter-personal variability in responses to     glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of     adverse side effects of glucocorticoid therapy, no assay is currently performed to determine     sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study     is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid     receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare     the results between severe and non-severe asthmatics.   "
121242|NCT01698970|"     A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups     of adult patients operated on for Crohn's disease, to determine if oral ingestion of     probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic     lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or     control product (N=56) during one year.   "
121243|NCT01698957|"     The purpose of this study is to detect if adding resistance to maternal blood flow from the     arm will help increase the blood flow through the uterine arteries to the placenta and the     baby.   "
121244|NCT01698944|"     This trial is conducted in Europe. The aim of this trial is to investigate the effect of     growth hormone on left ventricle morphology and function (systolic and diastolic).   "
121245|NCT01698931|"     This trial is conducted in Europe. The aim of this trial is to compare the efficacy of     repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2     diabetes.   "
121246|NCT01698918|"     The purpose of this study is to find out if combining everolimus with letrozole is safe and     has beneficial effects in postmenopausal women who have estrogen positive HER2 negative     locally advanced or metastatic breast cancer. Additionally, this study aims to find out if     everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive     locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole.     This study will also aim to find out if a mouth rinse can help reduce the severity of oral     stomatitis, a common side effect of everolimus. This part of the study will be conducted only     in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially     available.   "
121247|NCT01698905|"     A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in     chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib     (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for     at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at     least 3 years and have very small amount of leukemia cells remaining after the nilotinib     (Tasigna) treatment will qualify for the study.   "
121248|NCT01698892|"     Bronchoscopy is a technique which currently allows the investigation of many respiratory     diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic     procedures.      Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication     before endoscopy, but practices concerning the use of sedation further to the completion of     the endoscopy are very heterogeneous.      We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to     I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy   "
121249|NCT01698879|"     Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with     altered ripening capacity. Due to excessive proliferation, the blasts displace normal     hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate     extramedullary tissues.      Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all     patients and 15% lower when considering only patients over 65 years. Modifications to the     standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of     ara-C or adding a third drug.      Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a     cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to     CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ®     selectively transports the cytotoxic agent calicheamicin into leukemic cells and     hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the     pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of     the antibody anti-CD33 and its internalization by the cell, after which binds to and damages     the DNA.      Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse,     for patients older than 60 years non-candidates for other intensive treatment modalities.      Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the     conventional therapy, it is logical to conduct a phase II trial exploring the role of     Mylotarg ® in the early stages of treatment of AML.      Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined     with induction chemotherapy. The aim was to improve the CR rate reached with the latter and     reduce relapse after achieving greater leukemic cytoreduction.      Recent data from the HOVON group support that the administration of G-CSF before and during     induction chemotherapy decreases the incidence of relapse in patients with AML, particularly     those considered to have intermediate risk.      Everything mentioned above justifies to investigate the combination of GO combined with     chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of     sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is     effective and presents an acceptable toxicity it should be investigated.   "
121250|NCT01698866|"     The purpose of this study is to assess the seroconversion rate and the cellular immune     response after vaccination against hepatitis B virus in patients with lymphoproliferative     syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of     treatment criteria.   "
121251|NCT01698853|"     Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally     thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ     hypoperfusion.      Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde     perfusion. However,whether the arterial oxygenation status from different parts of the body     are the same in the condition of retrograde perfusion have not been studied.      The present study is aimed to determine if there is difference in the arterial oxygenation     between peripheral arterial and aortic root during the period of retrograde perfusion.In     addition, the impact of artificial ventilation on the difference of arterial oxygenation will     also be investigated.   "
121252|NCT01698840|"     Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation     at birth. However, few data are available related to follow-up of infants receiving these     formulas who were 28-34 weeks gestation at birth.      Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead     to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less     than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).   "
122890|NCT01677442|"     The purpose of this study is to compare results of general Video-assisted Thoracic Surgery     (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a     control group operated under general anesthesia with double-lumen endotracheal intubation.   "
121253|NCT01698827|"     Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in     the market, however durability is variable. In a prospective randomized study, five     commercial devices available in the market will be tested in 20 consecutive patients each.     Tube performance will be observed during 6 months and durability will be assessed by     Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design     and material will influence outcome.   "
121254|NCT01698814|"     The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic     solution in subjects 2 years of age and older with asymptomatic eyes when administered once     daily in both eyes for up to 6 weeks.   "
121255|NCT01698801|"     To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in     Japanese subjects with previously untreated multiple myeloma.   "
121256|NCT01698788|"     This study is undertaken to determine effect of sustained release dexamethasone     implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with     diabetic macular edema      Diabetic macular edema constitute important cause of visual impairment in patients with     diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .     Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,     Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections     macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs     to be removed by vitrectomy. Visual improvement after vitrectomy is related to the duration     of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after     surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections     to take care of residual macular edema.Intravitreal Triamcinolone Acetonide (TA), a water     insoluble steroid, has been shown to reduce the retinal thickness and improve the visual     acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a     major concern because of its short half life . In search for the ideal corticosteroid     preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS -     Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new     interest in this molecule. It is a sustained release intravitreal implant containing 700µg     dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of     macular edema in retinal vein occlusions. The present study introduces a novel concept of     using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect     in improving the surgical outcome   "
121257|NCT01698775|"     The purpose of this study is to evaluate the efficacy and safety of omarigliptin in     participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency     or end stage renal disease on dialysis with inadequate glycemic control. The primary     hypothesis of the study is that omarigliptin compared to placebo produces greater reduction     in glycosylated hemoglobin (A1C) after 24 weeks.   "
121258|NCT01698762|"     The goal of this research study is to compare a booklet and a DVD for patients with knee     osteoarthritis, osteoporosis, or rheumatoid arthritis.   "
121259|NCT01698749|"     This study is undertaken to determine the effect of intravitreal long acting dexamethasone     implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important     cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser     photocoagulation is the standard of care in its management. Several adjuncts including     intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal     anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.     Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to     reduce the retinal thickness and improve the visual acuity. However, recurrence of macular     edema in patients who receive intravitreal TA is a major concern as the patients need     multiple repeat injections because of its short half life. A more potent steroid,     dexamethasone has also been tried as an alternative to TA for macular edema; however, its     short half life of only 3 hours prevents its clinical application. In search for the ideal     corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System     (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.     Promising results have been shown in certain patients with retinal vein occlusions, uveitis     receiving this intravitreal drug delivery system with improvement in visual acuity. The     present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic     macular edema.   "
121260|NCT01698736|"     -  Recipient desensitization protocols were shown to enable successful living donor kidney          transplantation across major ABO blood group barriers. For extracorporeal depletion of          circulating ABO antibodies plasmapheresis or ABO blood group specific immunoadsorption          (IA) are most commonly used.        -  The efficiency of semiselective non-antigen specific IA in ABO-incompatible          transplantation is currently not well established. One potential drawback of          semiselective adsorbers could be an incomplete elimination of IgM.        -  This randomized controlled crossover trial was designed to clarify whether membrane          filtration, as an adjunct to semiselective IA, can substantially enhance elimination of          IgM.   "
121261|NCT01698723|"     The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by     an acute and rapid deterioration of liver function in a patient with previously     well-compensated liver disease owing to the effects of a precipitating event. In this     condition two insults act simultaneously, one being the preexisting liver injury (chronic     liver disease) and the other acute injury which is responsible for the acute decompensation.     HEV being a major factor responsible for this clinical entity and has a very high mortality     rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can     be an important drug in the treatment of these patients. Therefore the present study is     designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.   "
121262|NCT01698710|"     This research study is a pilot study. In this pilot study we are testing the safety of a     procedure. Investigational means that the Albumin bound paclitaxel (Abraxane) is still     being studied and that research doctors are trying to find out more about it. It also means     that the FDA has not approved Abraxane injection for your type of medical condition.     Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection     of the cysts. As part of standard medical care, you will be undergoing a diagnostic     endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of     the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the     injection of the drug into the cyst cavity if your cyst is thought to be cancerous or     precancerous. Cyst fluid will be analyzed for further diagnosis.   "
121263|NCT01698697|"     This trial is conducted in Africa. The aim of this trial is to determine if a new formulation     (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin     aspart formulation (U100).   "
121264|NCT01698684|"     The objectives of this study are to examine the therapeutic effects of two doses of avanafil     after dosing in men with erectile dysfunction   "
121268|NCT01698632|"     The purpose of this study is to learn more about the appearance and behavior of     benign-looking adnexal masses.        -  Benign-looking means that when viewed here by ultrasound it has the appearance of          looking not harmful or not malignant.        -  Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the          uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa          includes, but is not limited to, the ovaries and the fallopian tubes.        -  Masses refers to a variety of structures, including but not limited to:             -  ovarian cysts that are fluid filled sacs within or attached to an ovary             -  ovarian tumors that can be solid tissue or a combination of cysts and solid tissue             -  hydrosalpinges that are fluid collections in the fallopian tube      Many women have what appear to be benign adnexal masses. Many times, removal of the masses     with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these     masses could be cancer. There is not much information available for doctors to know how and     when to follow these masses, or which ones will become cancer.      This study will combine information from centers all around the world regarding the behavior     of all types of benign adnexal masses. The aim of this study is to develop decision tools for     doctors to know the best way to treat these masses in order to improve the detection of     ovarian cancer while at the same time reduce the number of unnecessary operations.   "
121269|NCT01698619|"     We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output,     Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen     Delivery in Climbers during their process of acclimatization on a expedition to Mount     Aconcagua.   "
121270|NCT01698606|"     In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim     of phase 2 of the project is to investigate whether a community-based, 12-month intervention     for overweight and obese preschool children 2-6 years of age and their families will be     effective in reducing the participants' degree of overweight (BMI z-score) and in improving     quality of life.      In the final phase (phase 3), participating children will be randomized to either receiving a     multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6     months later (control or wait list arm), in order to generate more robust effectiveness data.     Participants will receive an additional free 6-month YMCA membership while participating in     the study.   "
121271|NCT01698593|"     No one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without     epinephrine, but no one knows how the epinephrine affects the duration of the block. We also     don't know how long the pain part of the block lasts, which is what counts.      The goal of the study is to determine the duration of action of bupivacaine digital nerve     blocks (with and without epinephrine) on finger temperature and the sensory modalities of     pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be     injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12     hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain,     the Semmes Weinstein monofilament test to measure light touch and pressure and a body surface     thermometer to measure finger temperature. The time for the finger to return to normal     sensation and temperature will be measured.   "
121272|NCT01698580|"     This study is a clinical trial designed to evaluate the effectiveness of a multifactorial     falls prevention program in reducing the rate of falls.      A multifactorial falls prevention program consisting of an individualized medical management     of the modifiable risk factors, a progressive on-site body balance exercise plus a home-based     exercise program, an educational/behavioral intervention and a fall prevention booklet will     reduce the number of falls and fall rates when compared with usual care.   "
121273|NCT01698567|"     The purpose of this study is to discern whether supplementation of Antithrombin III will     decrease coagulation and inflammation associated with cardiopulmonary bypass in infants     undergoing cardiac surgery.   "
121274|NCT01698554|"     This study will evaluate the safety and efficacy of bimatoprost solution formulation A     compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash     hypotrichosis (inadequate eyelashes).   "
121275|NCT01698541|"     Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as     comparator, in elderly (>60 yr) renal transplant recipients   "
121276|NCT01698528|"     The purpose of this study is to determine if using a diabetes management technology system,     including a tablet computer, to track diabetes care and communicate with a clinician coach (a     doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer     for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology     system with a clinician coach helps more individuals starting basal insulin achieve better     glycemic control with less hypoglycemia compared with standard clinical practice at Joslin     Diabetes Center.   "
121277|NCT01698515|"     The objective of this study is to evaluate the effect of Tumor Necrosis Factor (TNF)     inhibition on oral parameters in patients with RA and to examine changes in levels of     proinflammatory cytokines in serum, gingival crevicular fluid (GCF), and saliva at an early     time point (6-8 wk) and a later time point (14-16 wk) after the initiation of therapy in     relation to concomitant assessment of Rheumatoid arthritis (RA) and oral clinical variables.      The purposes of the study are to:        1. Determine if oral periodontal parameters are affected by TNF inhibition;        2. Examine relationships between periodontal variables and RA variables with TNF          inhibition;        3. Determine if there may be potential early response markers of clinical RA response seen          using ultrasensitive analysis of oral or serum cytokines.   "
121335|NCT01697722|"     This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of     asthma management in patients with evidence of persistent asthma following an increase in     asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS)     using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised     metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS     plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone     propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and     BAIs.   "
122218|NCT01686217|"     The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different     strengths of ASP015K extended release formulation and an immediate release formulation and to     evaluate food effect on extended release strengths in healthy volunteers.   "
121278|NCT01698502|"     It is well known that continuous physical exercise leads to a number of changes in the body.     Maximal oxygen uptake; the heart's pumping ability and muscle mass and strength increases.     Also the metabolism adapts: The ability to oxidize fat increase and the insulin sensitivity     in primarily in muscle, but also in the liver increase.      Also endocrine glands adapts according to the level of physical activity. It is known that in     healthy, younger people the insulin secretion from the pancreas after administration of sugar     consumed orally or given directly into a vein, is significantly lower in trained individuals     compared with untrained. This change does, however, not only apply to glucose, as also     stimulation by the amino acid arginine, shows the same pattern.      It seems plausible that the endocrine glands/cells adapts to the level of physical training,     but this has not yet been investigated.      The gastrointestinal tract is the birthplace of a variety of hormones. One group of these is     called incretin hormones. They stimulate the glucose dependant insulin secretion in the     pancreas and affect hunger/satiety. Whether the incretin production and thus their     concentration in the blood is regulated by physical training is unknown.      Obese and patients with type 2 diabetes, has, in contrast to well-trained, decreased insulin     sensitivity. As a consequence their (type 2 diabetics, at least early in their disease     course) meal stimulated insulin release is greater than in healthy, normal weight     individuals. This in spite of the fact that the incretin effect is reduced in obese people     and patients with type 2 diabetes compared to healthy, normal weight.      Whether physical training affects both the secretion of incretins and the incretin effect has     not yet been studied.      The purpose of this study is to investigate whether incretin hormones in physical     well-trained young men have a changed effect on insulin secretion from the pancreas compared     to untrained young men. A difference may indicate that the body's endocrine glands adapts to     training mode.      The investigators hypothesis is that incretin hormones have a decreased effect on the glucose     dependant insulin release in physically trained persons and thus results in a lower insulin     release at any given plasma glucose level.   "
121279|NCT01698489|"     Closer examination of granular lipid data in a large population offers numerous opportunities     to generate new knowledge, ranging from studies examining concordance between commonly used     lipid parameters to phenotypic characterization of rare or extreme disorders of lipid     metabolism, opening possibilities to better personalize future treatment of abnormal blood     lipids.      STUDY POPULATION:      The Very Large Database of Lipids (VLDL) includes adults and children who were clinically     referred for a Vertical Auto Profile (VAP).      LIPID MEASUREMENTS:      The VAP test (VAP Diagnostis Lab, Birmingham, Alabama, USA) directly measures cholesterol     concentrations of low density lipoprotein, very low density lipoprotein, intermediate density     lipoprotein, high density lipoprotein, their subfractions, and lipoprotein(a). Triglycerides     in the database are directly measured using the Abbott ARCHITECT C‐8000 system (Abbott Park,     Illinois, USA). Lipid distributions in the database closely match those from the     population-representative National Health and Nutrition Examination Survey (NHANES).      STUDY PROCEDURES:      This database was investigator-initiated. Only de-identified data reach the investigational     site. The first data harvest was in 2011 and the second in 2016. The master database is     housed at The Johns Hopkins Hospital in Baltimore, Maryland, and maintained by Drs. Jones and     Martin. Only electronic data, and not biospecimens, are sent to Hopkins. The academic     investigators have unrestricted access to study data, take responsibility for the accuracy of     analyses, and have authority over manuscript preparation and submission.      VARIABLES:      The variables currently in the VLDL database are testing date, age, sex, fasting/nonfasting,     and components of the VAP test. From these primary variables, many additional variables were     derived for inclusion in the master database (e.g., non-HDL-C, Friedewald LDL-C, TC/HDL-C,     etc.). Other analytes measured by validated assays in subsets of the VLDL database include     apoB, apoA1, hsCRP, homocysteine, uric acid, insulin, hemoglobin A1c, 25-hydroxy vitamin D,     cystatin C, Liproprotein-associated Phosphatase (Lp-PLA2), Thyroid Stimulating Hormone (TSH),     free T3 and T4, pro- Brain Natiuretic Peptide (BNP), direct bilirubin, Creatine Phosphokinase     (CPK), creatinine and other components of the comprehensive metabolic panel, magnesium, and     phosphate.      DATABASE ORGANIZATION:      In the current database, each record represents a unique patient. The 1st available VAP test     for each patient is included. To meet the needs of a variety of research questions, we are     prospectively planning to organize harvest 2 data into 3-year interval datasets (i.e., VLDL     2006-2008, 2009-2011, VLDL 2012-2014, etc), a summation dataset (first VAP test for each     patient), serial lab dataset (patients who have had repeated testing), and ancillary datasets     (subsets of patients with coexisting data on other measures such as apolipoproteins, vitamin     D, hs-C-Reactive Protein (CRP), TSH/T4, etc).      INDIVIDUAL STUDIES:      Individual VLDL studies are based on a priori hypotheses or aims with statistical analysis     plans (SAPs) peer-reviewed prior to execution. In the expandable Detailed Description     section below, the VLDL investigators will periodically register individual studies and     update their status on clinicaltrials.gov.   "
121280|NCT01698476|"     The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate     together with standard anti-tuberculosis treatment to significantly improve clinical recovery     among patients with untreated, active pulmonary tuberculosis.   "
121281|NCT01698463|"     Falls and fractures are a leading cause of death and disability in the older adult     population. The consequences of falls and fractures contribute substantially to health care     costs and can have a significant negative impact on the quality of life of the individual.     Exercise has been studied as an option to reduce fracture risk and prevent falls though     improving balance and muscle strength. The prevention of falls is important, as a history of     falls is strongly predictive of suffering another. Those who are at a high risk of fracture     or falling require a patient specific assessment and individualized exercise prescription     that is tailored to their needs. This kind of program may not be typically available within     the community and at a low cost. These individuals may experience difficulty when trying to     engage in exercise due to barriers such as a lack of transportation, and a lack of knowledge.     As the first point of contact with the health care system for many family doctors are in the     ideal position to deliver exercise advice to their patients. However, a lack of time and     specialized skills in prescribing exercise make this difficult for many of them. As a result,     family health teams who provide interdisciplinary patient centered care are becoming popular.     In this model the care is shared and provided by the most appropriate team member (e.g.     doctor, nurse, exercise specialist). Additionally, many exercise interventions do not include     a behavior change aspect, which may be an important component when trying to get individuals     to engage in a new health behavior like exercise. Therefore the purpose of this project is to     assess the feasibility of implementing a tailored exercise program to those at high risk of     falls or fractures over the age of 65 in a primary care setting using an interdisciplinary     model of care that is based on a health behaviour change model.   "
121282|NCT01698450|"     The aim of this study is to asses the efficacy and the clinical safety of the transcranial     magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec     Ltd. for functional neurosurgery in the treatment of movement disorders. The treatments to be     conducted in this study are non-invasive, i.e. without opening the skull, and will create     microthalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The     data obtained in this study will be used to evaluate the basic safety aspects of this new     treatment technology and will serve as a basis for the clinical introduction of MR-guided     ultrasound neurosurgery.   "
121283|NCT01698437|"     Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal     ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the     target organ. The physician then identifies a target volume in the MR images and delineates     the treatment contours on the images. Therapy planning software calculates the parameters     required to effectively treat the defined target volume. During the treatment an ultrasound     transducer generates and focuses ultrasound energy to a focal point, called a sonication. The     sonication raises the tissue temperature within a well-defined region to a degree, which     causes thermal coagulation. MR images acquired during sonication provide a quantitative,     real-time temperature map of the target area to confirm the location of the sonication and     the size of the coagulated region. The sonication process is repeated at multiple adjacent     points to cover the entire prescribed treatment volume.   "
121284|NCT01698424|"     Our goal is to develop and test a new imaging technique to help scientists study sarcopenia,     the process by which muscle becomes weaker with age. This imaging technique uses Positron     Emission Tomography/Computed Tomography (PET/CT) scanners to measure the ability of muscle to     synthesize new protein. This ability to build new muscle protein is known as the Protein     Synthesis Rate, and is thought to decline as people age and to contribute to muscle     weakening. We are researching this technique in order to develop a tool to help scientists     and physicians better understand how muscle ages and how it changes based on some stimulus,     such as when people eat a high protein meal, exercise, or take muscle-building drugs. If our     research is successful, it will provide a new method for scientists and physicians to test     the effectiveness of new drugs and other treatments for muscle weakness. The study will look     for healthy woman between the ages of 65 and 80.   "
121285|NCT01698411|"     Several epidemiological studies in large cohorts suggest a strong association between sleep     duration, complaint of insomnia and risk of hypertension.These findings suggest an important     role of sleep quality in development of hypertension. Principal limitations of these studies     are the cross-sectional study design, self-report sleep duration and poor measurement of     blood pressure. The investigators propose to study an insomniac population with complete     evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement     of hypertension.   "
121286|NCT01698398|"     The purpose of the study is to examine the relationship between working capacity (peak oxygen     consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in     heart failure patients. The hypothesis is that it is possible to increase peak oxygen     consumption by incrementally increasing CF-LVAD pumpspeed during exercise.      The study population will consist of severe heart failure patients with CF-LVADs treated at     The Heart Centre of Copenhagen University Hospital Rigshospitalet.   "
121287|NCT01698385|"     OVERALL OBJECTIVES:        1. To assess the efficacy of a diet and exercise intervention before and/or during          pregnancy in the prevention of GDM and its fetal complications in women with high          diabetes risk.        2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention          of GDM from a socio-economic point of view. To find out whether the intervention can be          used to reduce health care costs due to GDM and T2DM.        3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention          in the reduction of T2DM incidence among women with prior GDM and their offspring      STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM     or BMI >30 kg/m2. N= 250 + 250.      Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI >30     kg/m2. N= 250 + 250      METHOD The Finnish multi-center randomized controlled intervention trial started in the     maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia     Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited.     Half of the subjects are randomized into the intervention group and the other half act as     controls receiving only standard antenatal care in addition to the laboratory tests taken and     questionnaires administered by the RADIEL study.      The active intervention arm of the study will be carried out in a structured, standardized     manner by diabetes nurses and nutritionists specifically trained for their tasks. The     intervention includes:        1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well          as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on          diet and exercise, setting of specific goals, follow-up of achievements, laboratory          tests and measurements        2. Structured group visits to nutritionist at the moment of enrollment in the study, at the          beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual          visits are booked if needed.        3. Services of physical activity advisors are provided by the study subjects' cities of          residence free of charge to all who wish to receive extra counseling on exercise. If          exercise goals are not met, study subjects book an appointment with the physical          activity advisor.      LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI > 25 and/or     limited weight gain during the first two trimesters in pregnancy if BMI > 30. 2.Exercise: A     minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate     intensity exercise (Borg 11-15). Daily household and/or transportation physical activity.     3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber,     low-fat dairy, vegetable fats; and use of plate model. Total energy intake: 1600-1800     kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein.      MEASUREMENTS of maternal variables:      AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy:      (1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT,     fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background     questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1).     Exercise diaries daily for one week.      PREGNANCY At the end of each trimester: (1) The same tests and measurements as in     pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire,     EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at     H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36.      POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same     follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post     partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits.     (5) Food and exercise diaries at 12 months post partum.      MEASUREMENTS of child's variables at birth      (1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery,     Apgar scores, any perinatal complications, operations, need of neonatal intensive care and     length of hospital. (3) Laboratory tests from cord blood.      TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800     subjects had been recruited to the study. Intervention will continue until 2014 (including     pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts     starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis     starts in autumn of 2013 and results will be reported from 2014 onwards in international     peer-reviewed journals.   "
121288|NCT01698372|"     This study will test the effectiveness of negative pressure wound therapy (using the VAC     Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary     Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention     may decrease the incidence of wound infection and non-infectious wound complications. It may     decrease wound discomfort and improve mobility and functional recovery of the leg.   "
121289|NCT01698359|"     Muscle-invasive bladder cancer affects over 3,000 new patients in the UK each year and     radiotherapy comprises a key part of the treatment pathway for many of them. Bladder     radiotherapy in the UK involves delivery of radiation to the entire bladder volume and aims     to deliver a high dose to the bladder while sparing nearby healthy organs (e.g. the bowel).     Unfortunately, large variations in bladder shape and volume are observed throughout treatment     that compromise the probability of a positive outcome for the patient, either by increasing     the risk of side-effects or by reducing the likelihood of adequately treating the disease.      In recent years, the implementation of 'adaptive' bladder radiotherapy strategies has     increased. These techniques allow modification of the treatment based on the observed     variations in bladder shape and volume. However, these strategies often rely on daily X-ray     imaging of the patient prior to treatment, which is time-consuming and associated with a     small risk of inducing a cancer in the patient.      This study will evaluate the potential of a commercially available ultrasound probe for use     as an alternative to X-ray scanning during treatment for these patients. The study will also     aim to compare the likelihood of reducing side-effects and successfully treating the disease     for the different adaptive strategies that are used around the world.   "
121290|NCT01698346|"     Despite good vaccination coverage, included in national immunization programs in developed     countries, the number of reported pertussis cases is rising, also in very young infants.     Current immunization strategies fail to protect infants too young to be immunized with the     licensed vaccine. Different strategies are possible to close the gap of susceptibility     between the loss of maternal antibodies and protection by vaccination. The main aim of the     present study is to measure the influence of an adult pertussis booster in pregnant women, on     the titer and duration of maternal antibodies in their infants. Early humoral immunity will     be assessed and the influence on vaccine response of the infant measured. The present study     offers the opportunity to have new insights in neonatal immunological mechanisms against     pertussis and a better understanding in strategies to protect infants against pertussis.   "
121291|NCT01698333|"     Adrenal suppression effects of corticosteroids are among the most important safety concerns     for this group of products. This study is designed to determine the adrenal effects of the     investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of     the formulation.   "
121292|NCT01698320|"     The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks     during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period     followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax®     device performance through the life of the device during the study.   "
121293|NCT01698307|"     Assess if the implementation of an enhanced treatment algorithm will improve the management     Crohn's Disease compared to a conventional Step-care approach.   "
121294|NCT01698294|"     This randomized clinical trial studies biomarkers in post-menopausal women receiving     flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants     receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.   "
121295|NCT01698281|"     This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard     single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free     survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative)     LHRH-R positive metastatic breast cancer.   "
121296|NCT01698268|"     Study measures the difference in pain after hernia &/or hydrocele repair based on site of     local anesthesia injection.   "
121297|NCT01698255|"     This randomized pilot study will test the feasibility of a behavioral intervention for late     life depression. Enrolled participants will receive 9 weeks of a specialized form of     psychotherapy we call ENGAGE or standard of care psychotherapy. ENGAGE is a stepped care     psychotherapy based on what is currently known about older adults' response to depression     interventions. Stepped care is a model of treatment that starts with the minimum effective     therapeutic techniques first, and then based on how well people respond to treatment,     additional therapeutic techniques are added until individuals recover from their depression.     The treatment components of ENGAGE were selected to match the most common problems seen in     older adults with depression. They include instructing the participant in basic problem     solving techniques and encouraging re-engagement in rewarding activities.      Participants will be depressed, older adult clients of Westchester Jewish Community Services     or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry.     In addition to receiving therapy, study participants will also undergo research assessments     at the beginning of the study and then at weeks 6 and 9.   "
121298|NCT01698242|"     The purpose of this study is to test whether a culturally sensitive self-management (SM)     intervention, compared to an education only control, will reduce all-cause hospital days in     patients with mild to moderate heart failure and household income less than $30,000 per year.   "
121299|NCT01698229|"     The purpose of this study is to obtain cerebrospinal fluid from healthy children already     undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy     controls when compared to children with late infantile neuronal ceroid lipofuscinosis     (LINCL), a fatal neurodegenerative disease.   "
121300|NCT01698216|"     The aim of this study is observation of effectiveness and side effect of patients with     schizophrenia who will switch the antipsychotics from risperidone long acting injection to     paliperidone palmitate.   "
121322|NCT01697930|"     This is a Phase I study. This study is the first time that a new experimental drug called     18FFluoroglutamine, or F-Glutamine, is being used in people. F-Glutamine is a drug designed     to be used with PET scanners that can 'see' where F-Glutamine goes in the body, after its     injected. PET scanners are one of the kinds of scanners you normally find in a hospital     radiology department. The researchers have found that tumors in animals absorb F-Glutamine.     The researchers believe that scans with F-Glutamine might be able to find tumors in patients.      This first in-human study is being done to see how long F-Glutamine lasts in the blood, when     it is given to people in tiny amounts by an injection, and to see where F-Glutamine goes in     the body. If the results of this trial are good, then the study doctors plan to use     F-Glutamine in another trial to see if scans with F-Glutamine are better for finding tumors     compared to the standard types of scans that doctors use.   "
121301|NCT01698203|"     Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is     contraindicated in certain patients. An alternative is continuous wound catheter analgesia.     We will investigate whether ropivacaine, administered through a wound catheter placed by the     surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult     patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be     randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75%     ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or     saline at the same scheme of administration. Patients will also benefit from     patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min),     paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary     endpoints will be pain intensity on a visual analog scale at rest and on coughing and side     effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the     nurses and caring staff involved in this study will be blinded. Solutions of saline and     ropivacaine will be prepared identically by the central pharmacy, without any possible     identification of the product.   "
121302|NCT01698190|"     The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is     more efficacious and cost-effective than the other while maintaining diagnostic accuracy in     the setting of solid gastrointestinal lesions.   "
121303|NCT01698177|"     Seasonal influenza (flu) is a significant and sometimes serious health issue in the U.S. The     Centers for Disease Control (CDC) estimates that over 200,000 people are hospitalized in the     U.S each year related to the flu. Public health campaigns advocate widespread vaccination for     the flu, and especially for high risk people. People with cancer are high risk, with an     increased risk of developing complications from the flu, such as pneumonia, bronchitis, or     worsening of other medical conditions. As part of their vaccination campaign, the CDC     strongly encourages inpatients to be vaccinated prior to hospital discharge. Accordingly,     Stony Brook Hospital has enacted a policy that mandates screening all hospital inpatients for     vaccination prior to discharge. While physicians or patients can opt not to vaccinate, the     default is to proceed. Surgical oncologists have several concerns about vaccinating their     patients after major surgical procedures. Patients with cancer have impaired immunity, and     the ability of our patients to mount an effective immune response to the vaccine is unclear.     Conversely, due to their immunocompromised state, our patients may be more susceptible to     complications from the vaccine, such as influenza-like-illness (ILI), or have higher rates of     postoperative complications due to the additional immune challenge of the vaccine. Previous     studies have evaluated the flu vaccine in patients receiving chemotherapy, or after organ     transplantation, but the combination of cancer and major surgery remains unstudied.      This is a collaborative study with Infectious Diseases and Microbiology to evaluate the     response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue     sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon     cancers). Patients will be randomly selected to receive the vaccine either 2 weeks     preoperatively or postoperatively at the time of discharge. Serum antibody response, rates of     ILI and post-op complications will be analyzed. The long term goal of this study is two-fold:     to determine the optimal time to vaccinate this group of patients in relation to their     surgery, and to improve compliance with vaccination.   "
121304|NCT01698164|"     This study is to evaluate the benefit/risk of hormone replacement treatment among early     menopausal women in China. This is a multi-centre, random, prospective study.   "
121305|NCT01698151|"     This is an observational study in primary care aiming to validate biomarkers for chronic     obstructive pulmonary disease (COPD).   "
121306|NCT01698138|"     This study is a double blind, randomized, placebo controlled trial to explore the effect of     early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord     injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20     patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30 ml     NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the same     procedure. The treatment will be repeated after three months. All included patients will be     evaluated with urodynamic examinations. Follow-up is 12 months after the first treatment. The     primary endpoint of the study is development of NDO.   "
121307|NCT01698125|"     The purpose of this study is to study aspects of autonomic cardiovascular control and the     level of stress hormones and inflammatory markers in saliva or serum, in elderly patients     exposed to elective, major abdominal surgery, with or without postoperative delirium, to     explore the hypothesis that delirium may be the result of aberrant stress responses.   "
121308|NCT01698112|"     This project is a clinical intervention trial that will determine the role of a functional     food, flaxseed, on the control of blood glucose levels in people with pre-diabetes. People     with pre-diabetes have high blood glucose levels since their cells do not respond to insulin     as they should. Over time, people with pre-diabetes may progress to type 2 diabetes and have     increased risk for heart and kidney diseases. Although the long-term complications associated     with type 2 diabetes are well-recognized, clinicians and researchers are now realizing that     some long-term damage to the body, especially the heart and circulatory system, may already     be occurring during pre-diabetes. Consequently, clinicians are recognizing that glucose     control, through diet, exercise and, if necessary, medications, is as important for people     with pre-diabetes as it is for people with type 2 diabetes.      Standard treatments for pre-diabetes are glucose control through diet, exercise, and drugs. A     possible treatment that could be added to the standard treatments is intake of flaxseed. Few     studies have looked at the effect of flaxseed intake on glucose control and those that have     enrolled people with type 2 diabetes. To date, no studies have reported flaxseed's affect on     controlling blood glucose in people with pre-diabetes. Therefore, more research is needed to     determine if flaxseed is an effective means of controlling glucose levels in people with     pre-diabetes.      This study will help determine whether or not eating modest amounts of flaxseed every day     will improve blood glucose and insulin levels in overweight or obese men and postmenopausal     women with pre-diabetes. It will also show if flaxseed intake will reduce the degree of     inflammation they are experiencing.      If flaxseed consumption does help control blood glucose levels in people with pre-diabetes     and reduce the degree of inflammation they are experiencing, it may help prevent or delay     their progression to type 2 diabetes.   "
121309|NCT01698099|"     Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated     appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in     discriminating between perforated and simple/no appendicitis.      Methods:      All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to     August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin     levels to detect perforated appendicitis.   "
121323|NCT01697917|"     The purpose of this study is to find out more about differences of the quality of life in     patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of     esophagogastric junction. To find a better reconstruction for patients who received total     gastrectomy.   "
121334|NCT01697735|"     Statins are cholesterol-lowering medications that are often prescribed for patients with high     cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients     whose hyperlipemia are not well controlled. If investigators are simply doubling the statins,     that only 6% of the benefit can be received. And it often has significant side effects in     elder patients. Several studies have suggested that the use of berberine can effectively     lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side     effects are seldom, the price of berberine is very cheap. The purpose of this study is to     observe the therapeutic effects of combination of statins and berberine on the patients with     hyperlipemia whose level of the lipid are not well controlled when only using statins.   "
121310|NCT01698086|"     Impaired standing balance, fatigue and abnormal eye movements are common problems in persons     with MS. These complaints are related to advanced disability and decreased quality of life     for persons with MS. Researchers from the University of Colorado and the Rocky Mountain     Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus have recently completed and     published a research study that showed an exercise program consisting of balance and eye     movement training, referred to as a vestibular rehabilitation program, was very effective in     improving self-reported fatigue and standing balance in persons with MS. This initial study     was the first to have proven that this type of exercise program is able to improve both of     these potentially devastating complaints.      The investigators from this initial study have partnered with other well-established     researchers from the University of Colorado Anschutz Medical Campus and the Rocky Mountain     Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus to advance our knowledge of     the effect of vestibular rehabilitation for persons with MS. Using the findings from the     initial study, the investigators propose to conduct a larger study specifically identifying     persons with MS who have brain lesion involvement in areas that control balance and eye     movements. Primarily, the current study will determine if those individuals who have     involvement in these areas of the brain improve more in balance and fatigue compared to those     who do not following participation in a vestibular rehabilitation program. Additionally, the     investigators will test if study participants who have abnormal eye movement control, will     improve their eye movement control following the training program. For persons with MS,     impaired eye movements can lead to a considerable decline in health status, further     illustrating the importance of the research plan to study this important factor.      The investigators believe that greater improvements in balance and fatigue are possible from     a longer treatment, and that participants who have brain lesion involvement in areas that     help control balance and eye movements will benefit greater than those who do not. This     information is important to determine who is more likely to benefit from a vestibular     rehabilitation program. Additionally, the researchers will be able to measure changes in eye     movement control, providing valuable insight into the reasons for the program's     effectiveness.   "
121311|NCT01698073|"     Youth who participate in the Circle of Life (COL) program will report less sexual risk taking     behavior compared to youth who do not receive the program.   "
121312|NCT01698060|"     The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted     adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a     radio controlled capsule. The secondary objective is to evaluate the immune response     (cellular and humoral) of two doses of ND1.1 oral vaccine.   "
121313|NCT01698047|"     The purpose of this study is to build a scientific evidence base for the training and     delivery of a depressive symptoms education program, developed by local community members,     called a Resiliency Class (RC). The RC has strong elements of Cognitive Behavioral Therapy     and is designed to be delivered as a psycho-educational class by non-professionals to improve     mood. Depressive symptoms are common, especially in low-income, minority communities.     Depressive symptoms that don't meet DSM-IV criteria for Major Depression still carry a     significant amount of disability. Interventions that address sub-threshold depressive     symptoms have been noted to result in a decreased likelihood of depression and diminished use     of mental health services. Few interventions using a health education / health promotion     focus are designed to be delivered by non-professionals to address individuals with mild to     moderate depressive symptoms in low income, minority communities. This project will take     place in the Centinela Valley, which roughly corresponds to Service Planning Area (SPA) 6 or     South Los Angeles (SLA). This single-blind, randomized trial will utilize a wait-list control     design where half of the participants enrolled in the study will be randomized to the     Resiliency Class (7 sessions) and half will go to a wait-list control condition where they     will receive 2 case management calls and referrals to social services. We propose to screen     1500 clients to detect about 450 participants with depressive symptoms (endorsed one item on     the PHQ-2). We plan to enroll 400 participants, 200 in the resiliency class and 200 in the     wait-list control condition. Primary outcomes measures will include depressive symptoms,     function, and measures of resiliency. We will assess these measures at baseline and at 3     months after completion of the Resiliency Class or wait-list condition. After the completion     of the first round of classes, we will conduct a preliminary analysis of the impact of the     resiliency classes versus the wait-list control case management calls on depressive symptoms.     If the resiliency classes improve depressive symptoms more than the wait-list control, we     will offer wait-list controls access to the resiliency classes and then disseminate the     resiliency class through trainings.      We hypothesize that the resiliency classes will lead to greater reductions in client     depressive symptoms than the wait-list case management calls in the randomized trial of this     project.   "
121314|NCT01698034|"     This study tested whether getting youth engaged in helping others (volunteering) would     benefit youth's physical health. 106 predominantly minority and low socioeconomic status     (SES) youth were randomized to either volunteer weekly with elementary school children in     after school programs or to a wait-list control group. The investigators hypothesized that     cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total     cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after     baseline) in the volunteer group compared to the control group. The investigators also     hypothesized that the intervention might work through pathways such as reducing negative     mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).   "
121315|NCT01698021|"     The new assay of troponins T (highly sensitive troponins) detects concentrations much lower     than before. Few data are currently available on their kinetics during acute coronary     syndrome, especially in regard to the correlation with CK MB. The aim of the present study is     to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to     correlate it with the concentration of CK MB, and possibly to evaluate their prognostic value     with respect to infarct size .   "
121316|NCT01698008|"     Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are     between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in the     study. Subjects will be randomized to two groups - iPhone versus standard of care and seen in     our clinic at an initial/baseline and three month clinical visit. The control group will     e-mail, fax, or call their blood glucose log results once a month for an insulin regimen     adjustment through verbal communication with a certified diabetic educator once a month as is     already implemented at the Diabetes Center. This group will be compared to the intervention     group who will submit their blood glucose log results through an iPhone mobile application,     called Diabetes Doctor, once a month for an insulin regimen adjustment by a physician with a     text message response. The two groups will have their HbA1c, hypoglycemic events, blood     glucose dispersion compliance, quality of life, usability and satisfaction with the use of a     mobile application will be assessed at each visit with surveys.   "
121317|NCT01697995|"     The objectives of this study are to determine the:        1. Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to          Exercise stress MPI in predicting a significant CAD.        2. Prognostic value of stress induced RV changes on Lexiscan stress MPI in predicting          adverse short-term and long-term clinical outcomes after the index test.   "
121318|NCT01697982|"     Hope is important to palliative home care patients. Our research team has developed a Living     with Hope Program that has been found to increase hope and quality of life in older persons     with advanced cancer.      The investigators want to know if this program increases hope and quality of life for all     palliative home care patients (all ages, all diagnosis). Thirty palliative home care patients     and their care partners will participate in this pilot study to evaluate the study procedures     and the living with hope program.   "
121319|NCT01697969|"     The purpose of this study is to descriptively evaluate the corneal structures of allergic     conjunctivitis patients.   "
121320|NCT01697956|"     The purpose of this study is to compare the effect of 6 weeks of treatment with     beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as     assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability     of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.   "
121324|NCT01697904|"     Preterm infants are born with immature lungs and often require help with breathing shortly     after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery     of high oxygen concentrations leads to the production of free radicals that can injure many     organ systems. Term and near-term newborns deprived of oxygen during or prior to birth     respond as well or better to resuscitation with room air (21% oxygen) compared to 100%     oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm     infants with lung disease.Purpose of the study is to investigate if preterm neonates where     resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations     (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the     oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to     infants where resuscitation is initiated with pure oxygen and titrated for targeted     saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest     included need for other delivery room resuscitation measures, respiratory support and     ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival     to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.   "
121325|NCT01697891|"     Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation     completion, can improve radiation-induced dysphagia and associated symptoms in head and neck     cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory     response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis.      Primary study objective: To evaluate the effectiveness of ALTENS in relieving     radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this     primary study endpoint.   "
121326|NCT01697878|"     The investigators propose to compare two different treatments, continuous positive airway     pressure (CPAP) versus breathing of atmospheric pressure, in subjects with obstructive sleep     apnea (OSA)recovering from weight loss surgery in the post anesthesia care unit (PACU). WE     hypothesize that subjects with OSA will have a higher Apnea-Hypopnea Index (AHI) with     desaturation and the investigators expect that post-operative CPAP treatment in the PACU will     significantly improve the AHI and therefore improve patient safety in the PACU. The     investigators also hypothesize that subjects with OSA have a greater decrease in oxygen     saturation in response to opioid administration by patient-controlled opioid analgesia (PCA).   "
121327|NCT01697865|"     The overall objective of this study is to compare the clinical benefit and safety of two     different surgical techniques of primary reverse total shoulder arthroplasty for the     treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres     minor dysfunction. The first surgical technique includes a concomitant latissimus and teres     major transfer (transfer group) and the second technique does not include a concomitant     latissimus and teres major transfer (control group).   "
121328|NCT01697852|"     The study is a cluster randomised trial to compare the effectiveness of indoor residual     spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the     effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary     outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years,     measured in cross sectional surveys. Secondary outcomes include relative population density     for each mosquito vector species, malaria transmission as measured by entomological     inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers     including kdr, and user acceptability of LLINs compared with IRS.      Findings from this study are expected to inform decision making so that resource utilization     can be optimised.   "
121329|NCT01697839|"     This is a prospective study investigating the relationship between vitamin D and peripheral     neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or     thalidomide. The study consists of a screening period of up to 14 days, followed by a single     assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic     pain, and markers of depression. Patient charts will also be utilized to assess the frequency     of skeletal-related events.   "
121330|NCT01697826|"     Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability     of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate     equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective     vaginitis.   "
121331|NCT01697800|"     Head and neck squamous cell carcinoma (HNSCC) is a lethal solid malignancy with 5 year     survival estimates of approximately 50%, and is associated with a high rate of systemic     immune impairment as well as evasion of a tumor specific immune response. Preclinical and     clinical data have shown that PDE5 inhibitors (tadalafil) can be used to augment immune     function in HNSCC patients through inhibition of the cancer-induced myeloid derived     suppressor cells (MDSCs).      A multi site phase II, randomized, prospective, biomarker endpoint trial to determine optimum     timing and design of PDE5 antitumor immunotherapy (tadalafil) in conjunction with     conventional therapy for HNSCC.      40 patients with biopsy proven HNSCC will be randomized to receive tadalafil (n=25) or     placebo (n=15) for at least 10-14 days before starting conventional therapy and continuing     until 90 days after completion of conventional therapy. Tumor-specific T cell responses will     be assessed using HNSCC cell lines, in blood collected before initiation of tadalafil/placebo     and at 60 and 90 days after completion of conventional therapy. Number and function of MDSC     and Treg cells will be assessed before and at 60 and 90 days after completion of conventional     therapy. Prevnar 13® vaccine will be administered 10-14 days after commencing     tadalafil/placebo (before conventional therapy begins) and again at 60 days after completion     of conventional therapy. Vaccine-specific responses assessed at 60 and 90 days     post-conventional therapy will be used to measure the ability of tadalafil to augment immune     response to vaccine.   "
121332|NCT01697787|"     This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of     Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy     positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid     Diagnosis Tests (RDTs) compared to the microscopy.   "
121333|NCT01697761|"     The purpose of this study is to determine whether acupuncture or moxibustion therapies are     effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the     content of Inflammatory factors and Neurotransmitter before and after acupuncture and     moxibustion therapy.   "
121336|NCT01697709|"     Despite a benign public perception, marijuana use disorders represent a significant public     health problem. The development of safe and effective pharmacotherapies for marijuana     dependence is an important unmet public health need. Quetiapine, an effective atypical     antipsychotic that acts by blocking serotonin type 2A, dopamine type 2, histamine type 1, and     adrenergic receptors, is a promising treatment for substance use disorders. In animal models,     quetiapine blocks the enhancement of reward by cocaine, which is likely due to its actions on     both dopamine and non-dopamine neurotransmission. Clinical studies of quetiapine have shown     benefit for the treatment of alcohol and cocaine use disorders.      Conceptually, the clinically prominent effects of quetiapine, namely sedation, anxiolysis,     mood stabilization and appetite stimulation, are a good match for the symptoms of marijuana     withdrawal. Most importantly, an open-label dose-finding study of quetiapine for the     treatment of marijuana dependence conducted by our research group determined that quetiapine     was well-tolerated and associated with reductions in marijuana use indicating that it is a     promising agent deserving of further study in marijuana-dependent outpatients.      The proposed research project is a randomized double-blind placebo-controlled clinical trial     to evaluate the efficacy of quetiapine for the treatment of marijuana dependence over a     12-week period. All participants will receive Medical Management, a medication adherence     focused psychosocial intervention that facilitates compliance with study medication and other     study procedures, promotes abstinence from marijuana and other substances, and encourages     mutual-support group attendance. All participants will receive voucher incentives for     compliance with study visit attendance, returning study medication bottles, and completing     other study procedures, with the objective of achieving a highly compliant sample. The goal     of this phase II clinical trial is to build on our promising open-label pilot study results     and examine the efficacy of quetiapine on participants' marijuana consumption under     placebo-controlled double-blind conditions using an abstinence-initiation model, where     participants will be using marijuana regularly at study entry, reduce their use, and then     achieve abstinence. The specific aims of the projects are to determine whether quetiapine is     superior to placebo in 1) reducing marijuana use and 2) achieving abstinence.   "
121337|NCT01697696|"     The purpose of the study is to provide long term safety data of NVA237. This study will     assess the safety and tolerability of a single dose strength of NVA237.   "
121338|NCT01697683|"     This study will add to the current knowledge and literature on the ability of an oral     lactobacilli preparation to return the vaginal flora to a normal state in pregnant women. The     results will potentially serve as the basis for a multi-centre Phase III randomized clinical     trial to determine the efficacy of this treatment in preventing preterm birth.   "
121339|NCT01697670|"     Objectives:      Primary: The primary study objective is to determine a clinical response as assessed by the     Mayo score to low dose PDT in patients with moderate to severe active distal UC.      Secondary: The secondary study objectives are to assess the effect on inflammation and the     safety and tolerability of low dose PDT in patients with moderate to severe active distal UC.      This is a multicenter, open phase II study that will enroll a maximum of 20 eligible patients     with moderate to severe active distal UC. The first 10 eligible patients, the first cohort,     will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no clinical     response is observed in the first 7 eligible patients, the study will be stopped due to lack     of efficacy. If at least 1 clinical response is observed in the first 7 patients, the first     cohort will be completed to a total of 10 eligible patients        -  Trial with medicinal product   "
121340|NCT01697657|"     This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to     investigate whether insulin detemir combined with insulin aspart compared to NPH insulin     combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst     maintaining the same degree of glycaemic control subjects with type 1 diabetes.   "
121341|NCT01697644|"     This trial is conducted in Europe. The aim of this trial is to assess and compare the     efficacy and safety of two dose levels of somatropin over a long period (till final height is     reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial)     and GHRETARD/BPD/20/NL (a 2-year extension trial).   "
121342|NCT01697631|"     This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control     of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in     patients previously treated with conventional Biphasic Human Insulin 30/70.   "
121343|NCT01697618|"     This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics,     pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.   "
121344|NCT01697605|"     This study will evaluate safety and tolerability to determine the Maximum tolerated dose     (MTD) and/or Recommended dose (RD).   "
121345|NCT01697592|"     This study will examine the safety and efficacy of the addition of omarigliptin in Japanese     participants with type 2 diabetes mellitus who have inadequate glycemic control on     diet/exercise therapy and oral antihyperglycemic agent monotherapy.   "
121346|NCT01697579|"     The purpose of this study is to determine the appropriate dosing regimen of fosaprepitant,     when administered with ondansetron (with or without dexamethasone), for the prevention of     CINV in children from birth to <17 years of age. Fosaprepitant is a prodrug to aprepitant.     All participants who complete the randomized Cycle 1 may elect to receive open-label     fosaprepitant during optional Cycles 2-6.   "
121347|NCT01697566|"     The goal of this clinical research study is to learn about the effects of metformin and/or a     program called lifestyle intervention on the endometrium (inner lining of the uterus) in     post-menopausal women who are also obese (both are risk factors for endometrial cancer).     Researchers also want to learn how insulin levels will be affected by metformin, diet and/or     exercise.      Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a     condition in which the body makes insulin but does not use it properly. It is often referred     to as pre-diabetes. Many people with insulin resistance have high levels of both sugar and     insulin in their blood at the same time, which have been reported in patients with     endometrial cancer.      In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks     like the study drug but is not designed to treat any disease or illness. It is designed to be     compared with a study drug to learn if the study drug has any real effect.      Lifestyle intervention is made up of a series of in-person sessions where you meet with a     coach to discuss strategies for losing weight and ways to increase physical activity. It also     consists of materials designed to help you lose weight and will offer opportunities for     supervised exercise.   "
121348|NCT01697553|"     The growth of the elderly population is associated with the autonomy failure and the increase     of dependence problems. Fall incidents are the third cause of chronic disablement in older     persons and are one of the major risk factors for entering in dependence.      The recent progress in home technologies and medical care are opportunities to search how to     apply these tools to reduce and prevent falling at home.      The purpose of this study is to evaluate the cost effectiveness of simple home automation     pack coupled to teleassistance service for preventing home falls in frail elderly population.      1200 patients will be enrolled and randmosied within two arms:        -  home with automation pack coupled to teleassistance service        -  home without this technology   "
121349|NCT01697540|"     1. Written informed consent must be obtained before any study specific procedures are          undertaken.        2. The process of the experiment (brief describe) The patients must come back for follow          during 4 to 12 weeks after starting the new therapy. The investigators will follow the          patients' lipid profile and any side effects and stop the observation till 36 months          after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride,          cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The          patients' chart and all data will be delinked to protect the patients' right and          privacy.   "
121350|NCT01697527|"     This phase II trial will examine whether genetically reprogramming a patient's disease     fighting white blood cells may build an immune response to kill cancer cells that express the     NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell     transplant along with a vaccine therapy. The vaccine will be made using the NY-ESO-1 protein     and may help to stimulate the engineered immune response to tumor cells.   "
121351|NCT01697514|"     The purpose of this study is to find a recommended dose level of LY2940680 that can be safely     given to children with medulloblastoma or rhabdomyosarcoma that has returned or doesn't     respond to initial treatment. The study will also explore the changes in a cancer marker     levels. Finally, the study will help document any antitumor activity.   "
121352|NCT01697501|"     This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with     HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the     predecessor ML18253 study. The study consists of a single visit where eligible patients will     undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.   "
121353|NCT01697488|"     This observational study will evaluate the safety, efficacy, quality of life and     predictive/selection factors for Avastin (bevacizumab) in combination with     carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian     tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be     collected during up to 15 months of treatment and 12 months of follow-up. A second     recruitment phase has been opened to focus on patients >/= 70 years.   "
121354|NCT01697475|"     This study examined the impact of using a motivational mobile text messaging intervention to     increase step count among older community-dwelling African Americans. Secondary aims were to     study the effects of text messaging on self-reported leisure time exercise behavior.      Hypothesis:      Participants in the motivational mobile text messaging group will have an increase step count     after 6-weeks.   "
121355|NCT01697462|"     This prospective observational study will evaluate the safety and efficacy of Xeloda     (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer.     Patients will be followed until disease progression or unacceptable toxicity occurs.   "
121356|NCT01697449|"     This prospective observational study will evaluate the safety and efficacy of Avastin     (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from     patients receiving Avastin in combination with chemotherapy according to registered     indication in routine clinical practice.   "
121357|NCT01697436|"     This four-period, single-center, open-label, single-dose, randomized, cross-over study will     assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a     Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four     sequences in which they will receive the treatment under fed and under fasted conditions.   "
121358|NCT01697423|"     The incidence of cartilage pathology has grown due to the ageing population, and the increase     in sports participation and its associated trauma. The aim of the treatment of symptomatic     osteoarthritis consists in reducing pain and improving the knee function in order to limit     the sport, professional and social negative impact in the youngest patients.      The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti     inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular     injections are proposed.      Intra articular injections of hyaluronic acid are recommended by the American College of     Rheumatology and the European League against Rheumatism for the treatment of knee     osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the     duration of clinical improvement which does not exceed 6 months.      The articular cartilage has a limited capacity for self-repair due to the low mitotic     activity of chondrocytes and its avascularity.      Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and     the cytokines, liberated by platelet degranulation. The influence of these growth factors in     the cartilage repair is being widely investigated in vivo and in vitro. These factors could     stimulate the chondral reparation via a neovascularization, a collagen synthesis and an     activation of the chondrocytes.      The hypothesis is that the intra articular injection of PRP, with its capacity to enhance     articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the     treatment of knee osteoarthritis resisting the oral drugs.      Material and methods: We intend to conduct a comparative, monocentric prospective randomized,     double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results     of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.   "
121359|NCT01697410|"     The purpose of this study is to evaluate the efficacy of terlipressin for treating septic     shock.   "
121360|NCT01697397|"     A feasibility study for monitoring and recording gastrointestinal (GI) myoelectric activity     in subjects with suspected or diagnosed irritable bowel syndrome (IBS) and reports of GI pain     and asymptomatic subjects without IBS and GI pain.   "
121361|NCT01697384|"     Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant     (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer     during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified     to eliminate the Lupron arm and continued the study as an open-label non-randomized study.      Primary endpoint was testosterone suppression, as assessed by the percent of patients whose     testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment     with an implant.   "
121372|NCT01697241|"     The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis     postpone time to hip replacement surgery following participation in a patient education and     supervised exercise program when compared to patients receiving patient education alone.   "
121373|NCT01697228|"     The investigators are conducting a prospective cross-over study to evaluate the effects of     vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in     microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to     see a significant improvement in glycemic control and a reduction of serum pro-inflammatory     markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who     are treated with vitamin D.   "
125013|NCT01649362|"     The objective of this study is to evaluate the efficacy of an oral stimulation program on the     length of the transition period in preterm infants (primary outcome), the length of hospital     stay and the breastfeeding rates at discharge (secondary outcomes).   "
121362|NCT01697371|"     Local control of hepatic metastases appears to be a major determinant of overall survival.     However, many patients are not suitable for resection due to medical or surgical reasons.     Therefore, there is an important role for a treatment that can provide the equivalent of     tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an     ablative regimen of highly focused external beam radiotherapy that targets one or more     discrete extracranial lesions. Published reports using SBRT to treat liver metastases have     shown actuarial local control rates ranging from 50-100% with higher doses associated with     better local control.      In patients with metastatic liver disease, aggressive local therapy using modern radiotherapy     techniques are promising and project to have a substantial role in the treatment of     metastatic liver cancer to treat unresectable disease. The dosimetric advantage of proton     therapy may lead to improved clinical outcomes with less morbidity, however, there is no     clinical data to confirm this assertion. We thus propose a phase I study to determine the     feasibility and safety of stereotactic body proton therapy in patients with liver metastases     followed by a phase II study to determine the efficacy of such treatment on local control.   "
121363|NCT01697358|"     The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS)     using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management     (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed     back surgery syndrome (FBSS).   "
121364|NCT01697345|"     It is well documented that women who have breast cancer may experience a decrease in quality     of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically     aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital     and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can     impair sexual functioning and cause a decreased sexual health quality of life.      At the present time, there are no Food and Drug Administration (FDA) approved medications for     the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment     options is concerning because the number of women diagnosed with breast cancer continues to     increase; their longevity, also, continues to increase with the use of newer adjuvant     chemotherapies. Local health care practitioners have observed that the benefits of vaginal     testosterone for sexual health in breast cancer survivors are similar to the benefits of     vaginal estrogen in women without breast cancer.      The purpose of this study is to evaluate the impact of using a daily compounded vaginal     testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of     vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and     sexual functioning.   "
121365|NCT01697332|"     The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe     MRI to measure lung function and its potential to sensitively detect pulmonary disease and     its progression in COPD. We hypothesize that measurement of alveolar surface area, septal     thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate     better with quality of life measures in COPD subjects than traditional diagnostic measures     such as spirometry and Computed Tomography.   "
121366|NCT01697319|"     The primary objective of this study is to evaluate the effect of 2.0 mg/kg/week BMN 110 in a     patient population that has limited ambulation, in a period of up to 144 weeks.   "
121367|NCT01697306|"     To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and     intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was     to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive     (NMIBC) patients treated with BCG or gemcitabine.   "
121368|NCT01697293|"     This phase I/II trial studies the side effects and the best dose of triciribine phosphate     when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to     see how well they work in treating patients with stage IIB-IV breast cancer. Triciribine     phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving     triciribine phosphate with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide may be     a better treatment for breast cancer.   "
121369|NCT01697280|"     This study aims to assess if pictorial messages promoting routine immunization during     supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can     improve immunization rates. A cluster randomized trial design in low literature populations     will be used.   "
121370|NCT01697267|"     Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody     (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its     effect wears off and the disease can return. This occurs in at least half of patients within     2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating     rituximab every six months stops the disease returning and is safe.      The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and     whether it works better than the older treatments, azathioprine or methotrexate. It will also     tell us how long patients remain well after the repeated rituximab treatments are stopped,     and if repeated rituximab is safe. We should also learn useful information about the effects     of rituximab on quality of life and economic measures. The trial results will help decide the     best treatment for future patients who have their vasculitis initially treated with     rituximab.      RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come     back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we     anticipate that most will respond well. If their disease is under reasonable control after     four months, further treatment with either rituximab (a single dose ever four months for two     years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and     azathioprine groups will then be compared. Patients will be in the trial for four years.      The study has been designed by members of the European Vasculitis Study group (EUVAS) and the     Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30     hospitals in Europe, the USA, Australia and Mexico.      RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health     and by Roche/Genentech.   "
121371|NCT01697254|"     This CARRA Registry study will create a foundational database for rheumatic diseases of     childhood using a novel informatics infrastructure developed as part of the larger clinical     project. The creation of a CARRA-wide informatics infrastructure will enable efficient,     observational, disease-related data capture across all CARRA sites for pediatric rheumatic     diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data     intensive registries for observational studies, comparative effectiveness research,     pharmaceutical clinical trials and translational research.   "
125014|NCT01649349|"     The purpose of this studyis to assess the feasibility and safety of novel designed two-piece     nasogastric tube.   "
121376|NCT01697189|"     The general aim of the study is to promote safe, economic, and environmental-friendly driving     among long-haul truck drivers. To do this, the investigators will conduct an on-road study on     i) the relationship of driver sleepiness and stress with driving behaviour and fuel     consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at     the wheel. The educational intervention is designed to be employed by occupational health     care professionals in the future. This solution clearly facilitates the implementation of the     intervention into practice if it turns out to be effective.      The investigators specified research questions are the following:        -  Do truck driver sleepiness and stress at the wheel reach levels that affect driving          behaviour, fuel consumption and carbon emissions?        -  What are the sources of sub-optimal arousal at the wheel in truck drivers?        -  Can truck driver sleepiness be mitigated by an educational intervention, and if yes,          does it improve driving behaviour and decrease fuel consumption and carbon emissions as          well?   "
121377|NCT01697176|"     This is an observational study of lone Coronary Artery Bypass Grafting procedures with     endoscopic vein graft harvesting using best harvesting practices.   "
121378|NCT01697163|"     This study is based on the following hypothesis De novo resistance to EGFR-TKI in EGFR     mutation positive patients is related with mutations in EGFR downstream genes.      Investigators will prospectively collect genomic DNA and clinical data regarding treatment     outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will     sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification     and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification,     and protein over expression as predictive markers of treatment outcomes, investigators     analyzed the association of treatment outcomes with the presence of genetic alteration or     protein over expression. Investigators will attempt to identify biomarkers that are able to     predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.   "
121379|NCT01697150|"     Automated closed-loop control (CLC) of blood glucose, known as artificial pancreas (AP) can     have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The     investigators inter-institutional and international research team has been on the forefront     of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006.     Thus far, the investigators have conducted three closed-loop control clinical trials     (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable     target blood glucose range during CLC, and significantly fewer hypoglycemic events during     CLC compared to open loop. The investigators overall objective is to sequentially test,     validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range     (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a     Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's     continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also     monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations     or loss of sensitivity. The HMM will be responsible for the optimal regulation of     postprandial hyperglycemic excursions through correction boluses.      This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and     (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who     are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local     hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for     validation that remote system monitoring can successfully occur. During the study, study     subject will be responsible for. operating the CTR system with nursing and technicians     available   "
121380|NCT01697137|"     The number of persons on the national solid organ waiting list continues to increase while     the number of donated organs has failed to keep pace. In some portions of northeastern Ohio     the donation rate is as low as 32%. There is a positive association between discussing organ     donation with a primary care physician and signing a donor card. However, such discussions     are rare. The investigators propose a blinded randomized controlled trial to evaluate the     effectiveness of two interventions: 1) showing a donation video to patients in primary care     settings waiting to see their physician and 2) cueing of primary care providers to have     donation discussions with their patients. The study will be conducted throughout Cuyahoga     County in at least 10 ambulatory clinics associated with a single county medical system. Nine     hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that     patients exposed to the interventions will be 1) more likely to consent to donate organs, 2)     more likely to have donation discussions with their primary care providers, and 3) equally     satisfied with the time spent with their doctor compared to patients who are not exposed to     the interventions.   "
121381|NCT01697124|"     The Children in Action (CIA) program was a five month physical activity intervention. This     intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start     centers. After baseline assessment, centers were matched by ethnicity and for number of     participants and randomly assigned to either the intervention or the control condition. A     total of 224 preschool children were randomly selected across the four centers. To evaluate     the efficacy of the CIA intervention, the change in physical activity, gross motor skills and     weight during the awake time and used mixed effect time-series regression models was     compared. Observations did not show a statistical difference between intervention and control     groups in physical activity level during the awake time, gross motor development or weight     status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among     preschool children attending Head Start Centers but that an increased dose and/or longer     intervention duration will be required to impact gross motor skills, weight status and     physical activity levels during this critical early childhood development stage.   "
121382|NCT01697111|"     This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study     (24-week treatment-comparison phase) with an open-label reference arm of active comparator     (dienogest) followed by 28-week long-term treatment phase.      The primary objective of this study is to confirm the superiority of BAY86-5300 when     administered with an extended flexible regimen for the treatment of endometriosis-associated     pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.      The secondary objective is to investigate the long-term safety of BAY86-5300 in patients     treated with an extended flexible regimen for one year, and the bleeding pattern of     BAY86-5300 when administered with an extended flexible regimen compared to dienogest.   "
121383|NCT01697098|"     The investigators sought to determine whether the incidence of neonatal respiratory distress     syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of     dexamethasone.   "
121384|NCT01697085|"     Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous     membranes   "
125042|NCT01648959|"     Various parts of the brain are sensitive to various anesthetics.We like to study the effect     of dexmedetomidine on the different parts of the brain in patients who are coming for DBS     electrode removal under sedation.   "
121386|NCT01697059|"     Several recent studies have examined the feasibility and benefits of nonoperative treatment     of perforated appendicitis in children. One such study showed a trend toward longer operative     times for patients randomized to immediate appendectomy, but no overall advantage. In another     larger study, the costs of delayed appendectomy for perforated appendicitis were higher - in     part related to readmissions in the interval (6-8 weeks). Nevertheless, these and other     studies have demonstrated the safety of delaying appendectomy for perforated appendicitis.      Emergency appendectomy is a well-established approach, and postoperative recovery in children     is fast. Nevertheless, from the onset of symptoms through the hospital stay and the     postoperative recovery, appendicitis causes a disruption of a family's normal routine     (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation,     patients have to wait until an operating room becomes available, or elective operations have     to be placed on hold to accommodate the emergency operation. Each year, more than 250     children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery,     or about one emergency add-on operation per working day. If an initial trial of antibiotics     is safe for the treatment of appendicitis, converting an emergency operation into an     elective, scheduled outpatient procedure may reduce stress and disruption of routine for     patients and their families - and may allow better operating room planning for health care     professionals and hospitals.      The investigators hypothesize that initial antibiotic treatment of acute (non-perforated)     appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of     treating the disease and results in greater patient and family satisfaction.      This pilot study aims to establish the safety and feasibility of treating acute appendicitis     with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and their     families will be offered the possibility of initial nonoperative treatment and subsequent     outpatient elective appendectomy in a nonrandomized, single arm study.   "
121387|NCT01697046|"     This will be a pilot, open label study involving 65 participants. All participants will be     followed until seroconversion or until the last enrolled participant completes one year of     follow-up, whichever happens first. Participant study number will be given at the screening     visit, prior to inclusion in the study.      The chosen intervention and study regimen are based on the dynamics of viral infection and     the pharmacokinetics of the study drugs. In order to inhibit reverse transcription nucleoside     and nucleotide analogues need to be phosphorylated intracellularly. On the other hand,     available data indicate that it takes approximately 10 hours between exposure and HIV viral     integration, offering a window of opportunity for Raltegravir to block integration and thus     prevent infection, given that this drug does not need to be metabolized to exert its effect.     The intervention will be maintained for 4 weeks following exposure, in accordance with     Brazilian and CDC guidelines for PEP.   "
121388|NCT01697020|"     The primary objective of this study is to determine whether the test product, mercaptopurine     oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are     bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared     after administration of a single dose of each of the two formulations, under fasting     conditions. The secondary objective is to assess the safety and tolerability of the test     product, mercaptopurine oral 100 mg/5 mL suspension.   "
121389|NCT01697007|"     Electroporation will increase the efficiency of DNA priming in terms of immune responses and     will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine     concentration will reduce the number of shots necessary to deliver the full dose and induce     comparable immune responses as with lower DNA vaccine concentrations.   "
121390|NCT01696994|"     This clinical trial studies whether screening methods used to diagnose cancer of the     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening     tests may help doctors find cancer cells early and plan better treatment for ovarian cancer.     The ovarian cancer screening tests are part of a trial that addresses the screening of four     cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968),     colorectal (NCT01696981), and ovarian (NCT01696994).   "
121391|NCT01696981|"     This clinical trial studies whether screening methods used to diagnose cancer of the     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening     tests may help doctors find cancer cells early and plan better treatment for colorectal     cancer.   "
121392|NCT01696968|"     This clinical trial studies whether screening methods used to diagnose cancer of the     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening     tests may help doctors find cancer cells early and plan better treatment for lung cancer.   "
121393|NCT01696955|"     This randomized phase II trial studies how well cetuximab with or without tivantinib works in     treating patients with head and neck cancer that has come back (recurrent), has spread to     other places in the body (metastatic), or cannot be removed by surgery. Monoclonal     antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and     spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. It is not yet known whether cetuximab is more effective with or without     tivantinib in treating patients with head and neck cancer.   "
121394|NCT01696942|"     Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates     compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy     for Crohn's disease.        1. To evaluate the difference in clinical recurrence rates between certolizumab and          mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following          ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI).        2. To compare the endoscopic recurrence rates at one year following surgery between          patients treated with certolizumab and mesalamine.        3. To compare medication side-effects and tolerance of therapy, including the need to          interrupt therapy due to side-effects, the incidence of opportunistic infections, and a          general assessment of each patient's health and well-being using the short-form 36          (SF-36).   "
121407|NCT01696773|"     Eating a diet rich in tomatoes has been associated with decreased risk for a variety of     diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments     called carotenoids), which has been associated with the decreased risk of disease in those     consuming tomato products; however, tomatoes also contain flavonoids, which may also have     health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in     a different form that in red tomatoes and this contributes to their characteristic orange     color. This orange lycopene is more similar to the most common form of lycopene found in     the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by     the body.      The objectives of this study are to determine if carotenoids and flavonoids from Tangerine     tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating     Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances     by the body).   "
121717|NCT01692847|"     A hospitals manual method of patient monitoring will be implemented in an automated system     and supported by an early patient deterioration detection for timely escalation. The purpose     of this study is to assess if clinical outcomes of patients in Acute Care are significantly     improved by such a system.   "
121395|NCT01696929|"     This study is a Phase 1 clinical trail to determine the safety, tolerability, and efficacy of     Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with     schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant     humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin     (Ig) gamma-1 subclass. Tocilizumab is formulated as a concentrate for solution for infusion,     and will be administered by intravenous infusion.      The investigators propose an 8-week trial to determine the safety, tolerability, and     effectiveness of tocilizumab, given in addition to antipsychotic medications, in 10 stable     outpatients with schizophrenia. The investigators hypothesize that tocilizumab will be     associated with clinically significant improvement in cognition and total psychotic symptoms     over the course of the trial. Tocilizumab is administered as an intravenous infusion every 4     weeks. Following a screening evaluation, participants will receive two infusions of     tocilizumab, one at baseline and another at week 4 of the study. The investigators will     measure changes in cognitive function and symptoms over an 8-week period. Complementing     previous positive clinical trials of non-steroidal anti-inflammatory drugs, this would be a     proof-of-concept study that targeting specific cytokines is a viable treatment for     schizophrenia.      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by     Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical     development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for     Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002,     respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003.      Data presented in 2008 showed the effectiveness of tocilizumab in combination therapy with     methotrexate for rheumatoid arthritis treatment. In further studies, it was effective and     generally well tolerated when administered either as monotherapy or in combination with     conventional disease-modifying antirheumatic drugs in adult patients with moderate to severe     rheumatoid arthritis.   "
121396|NCT01696916|"     The aim of this study is to investigate the development of partial pressure of carbon dioxide     during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease     (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen     saturation and the heart rate are registered by a device called Sentec during the mentioned     periods. In addition a measurement of activity is realised by an activity monitor     (Sensewear).   "
121397|NCT01696903|"     Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile     system or the duodenum that is associated with a high rate of complications. The study wants     to investigate whether a new technique to reconstruct the joint between the pancreatic gland     and the short bowel can reduce the rate of severe complications after this complex surgical     procedure.   "
121398|NCT01696890|"     The aim of this study is to evaluate this model of telemonitoring-assisted close supervision     and interaction between first and second line health professionals versus a model of     telemonitoring without this integrated approach.   "
121399|NCT01696877|"     This research is being done to see if an investigational prostate cancer vaccine, called     GVAX, can safely be given together with a single intravenous injection of a drug called     cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands     who have also received standard hormonal therapy.   "
121400|NCT01696864|"     The objective of this study is to examine monitored rehabilitation therapy over the internet     to improve upper limb function for stroke patients. Home rehabilitation for stroke patients     will avoid the burden of arrival to the health facilities, making it easier on them and     improve their quality of life and the lives of their caregivers. To achieve this goal the     investigators will examine the effectiveness and feasibility of home rehabilitation system of     upper limb, consisting of ergonomic accessories (hand and arm tutors).      The quantitative indices will be based on the quantitative clinical measures that are used in     regular evaluations of stroke patients and function and range of motion indices as received     from the system.   "
121401|NCT01696851|"     People with Spinal cord injury with tetraplegia suffer from respiratory problem due to     weakness of the muscles and because the autonomic system dysfunction.      Exercise is one way of preserving and improving physical fitness and directly and indirectly     reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects     with spinal cord injury with tetraplegia have limited options for exercise: table tennis,     gym, pool and more. Because of the nature of the injury which includes the sympathetic     failure, they can not easily get the desired pulse to improve physical fitness.      Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could     not participate in wheelchair basketball. The game combines short, quick races with different     aerobic capabilities. Previous studies have shown that participants in wheelchair rugby     Improve anaerobic power, oxygen consumption, physical fitness and daily functioning.     Wheelchair rugby improves self-confidence and as a result it affects other areas of life.     Another study examined sense of self-efficacy, saw improvement in this index for rugby     players in a wheelchair at high levels.      In the present study the investigators aim to examine whether regular participation in     wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym,     swimming).   "
121402|NCT01696838|"     The purpose of this study is to determine whether acupuncture or moxibustion therapies are     effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate     the efficacy by functional magnetic resonance imaging.   "
121403|NCT01696825|"     The purpose of this study is to determine which of three delivery systems of vaginal diazepam     have the best systemic absorption, measured by serum diazepam levels. The three delivery     systems are: moistened tablet, suppository or cream. Additionally the study will compare the     side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used     off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic     floor dysfunction.   "
121404|NCT01696812|"     The objectives of this study are (1) to compare the clinical outcome in correlation with the     electrode positions estimated by web-based image fusion of the preoperative MRI and the     postoperative brain CT taken at a stable period after surgery using mutual information     technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and     (2) to examine whether the documentation of the electrode position by using mutual     information technique at a stable period after unilateral or bilateral STN stimulation     provides useful information for the postoperative programming.   "
121405|NCT01696799|"     To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in     subjects with interdigital tinea pedis aged 12 years to less than 18 years.   "
121406|NCT01696786|"     The specific aim of this study is to further develop methods of oocyte cryopreservation and     evaluate their impact on reproductive outcomes.   "
121440|NCT01696344|"     This prospective study aims to investigate if termination of atrial fibrillation (AF) after     pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in     long-standing persistent (LSP) AF, is enough to ensure long-term success.   "
121408|NCT01696760|"     This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and     pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic     compression devices in preventing deep vein thrombosis in patients with pelvic and lower     extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also     known as sequential compression devices and are inflatable compression sleeves that are     placed around patient's legs to reduce the risk of clot formation deep vein thrombosis.     Pneumatic compression devices are made of a soft material that wraps around the lower leg and     periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized     patients wear these as a preventive measure. Pneumatic compression devices alone are not     sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin     and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in     patients with musculoskeletal tumors which have determined whether one drug is better than     another. The knowledge gained from this study will determine whether aspirin and pneumatic     compression devices is the same or better than enoxaparin and pneumatic compression devices     in preventing deep vein thrombosis in this patient population and may result in fewer wound     and bleeding complications   "
121409|NCT01696747|"     To expand a registry of patients for the study of the epidemiology, etiology, and degree of     morbidity associated with gastroparesis.   "
121410|NCT01696734|"     The goal of this clinical research study is to learn if domperidone can help to control     chronic GI disorders. The safety of this drug will also be studied.      Domperidone is designed to stimulate contraction of the stomach to increase its ability to     empty itself of the food.   "
121411|NCT01696721|"     In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better     results in treating patients with cancer, both because there is better control of where in     the body the radiation is directed and because it is associated with less severe long term     side effects. However, there is limited published data demonstrating these results. The goal     of the Pediatric Proton Consortium Registry (PPCR) is to enroll children treated with proton     radiation in the United States in order to describe the population that currently receives     protons and better evaluate its benefits over other therapies. The data collected from this     study will help facilitate research on proton beam radiation therapy and allow for     collaborative research. The PPCR will collect demographic and clinical data that many centers     that deliver proton radiation therapy already collect in routine operations.   "
121412|NCT01696708|"     The purpose of this project is to study brain energy profile evolution at different stages of     the Huntington disease.   "
121413|NCT01696695|"     This observational study will evaluate the efficacy and safety of different capecitabine     based chemotherapies, alone or in combination with other therapies, as first line treatment     of metastatic colorectal cancer in participants during everyday clinical practice.   "
121414|NCT01696682|"     The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize     anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this     random-controlled research, and investigate the leakage ratio from different widths of     gastric conduit formed during the operation.   "
121415|NCT01696669|"     Tumors of the Ewing sarcoma family (ES) affect children, adolescents and young adults. The     reported incidence is 0.6 cases per million inhabitants every year. The peak incidence occurs     between 10 and 20 years and it is rarely diagnosed beyond 30. The ES is a severe disease with     a progression-free survival after 5 years of 60% in cases without metastasis and deadly in     the majority of patients presenting metastasis. The ES is considered a systemic disease     because, despite receiving an adequate local treatment, over 90% of patients deaths occur due     to disseminated disease. Combined therapy of surgery, radiotherapy and chemotherapy has led     to an improvement in the prognosis, achieving a survival of about 60% in most series      The MSKCC P6 protocol was developed for the treatment of high risk ES. In 2003, Kolb et al.     reported the MSKCC experience after a 4-years follow-up of 68 patients who had been included     from 1990 to 2001. Following the MSKCC P6 protocol, a survival rate of 82% was achieved in     patients without metastasis, superior to the achieved with less intensive protocols.     Following the guidelines of the MSKCC P6 protocol, in 2002 we modified the treatment schedule     to create the modified P6 protocol (MP6). GEIS intends to develop MP6 as a clinical trial,     which could provide the following potential advantages about current treatments:        1. Lower total dose of alkylating agents.        2. Early cardioprotection with dexrazoxane.        3. Radiotherapy adjusted to the initial response.        4. Pilot trial with the combination of Gemcitabine + Docetaxel for high-risk patients.   "
121416|NCT01696656|"     Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with     significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition     as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and     symptom-relieving agents may be required. Prescriptional pattern of these drugs will be     analyzed in a clinical cohort.   "
121417|NCT01696643|"     The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for     the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for     chronic non-cancer pain.   "
121418|NCT01696630|"     This is a monocentric study in 2 steps: A safety part to assess the feasibility of using     Xenon in association with a thoracic epidural analgesia (TEA) with a sequential recruitment     of 3, 6 or 9 patients according to predefined safety rules. The second part will randomly     allocated patients (1:1) to receive TEA+Xenon or TEA+Desflurane. 28 patients will be enrolled     and followed over 45 days.   "
121419|NCT01696617|"     The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of     standard antidepressants would be associated with improved depression response in Major     depressive disorder, especially in Quality of life.      The investigators compare the mean changes in the quality of life between before add-on and 8     weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of     aripiprazole.   "
121441|NCT01696331|"     Text message reminders will improve adherence to lab tests in adolescent liver transplant     recipients.   "
121442|NCT01696318|"     Develop and evaluate a model of organization and management in the management of patients     with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical     inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control     and treatment effectiveness.   "
121420|NCT01696604|"     This study is the first administration of GSK2849466 in humans. This will be a single centre,     randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability,     pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849466, given as single and repeat     oral doses up to 14 days to healthy male subjects. Part A will be a randomized placebo     controlled and 4-way crossover study. It will include two cohorts of 8 subjects each. In each     cohort there will be 4 study periods each approximately of 1 week including 6 days of     washout. Each subject will receive a total of 3 active doses as ascending single oral dose of     GSK2849466 and 1 placebo dose during the course of their participation in the study. The     first (bridging dose) dose provided to subjects in Cohort 2 will be the same as the last     dose provided to subjects in Cohort 1. The single doses of GSK2849466 planned in Part A of     this study are: 0.01, 0.03, 0.1, and 0.3 milligram (mg) in Cohort 1 and 0.3, 1, 3, and 10 mg     in Cohort 2. In cohorts 1 and 2 all available safety, tolerability, and PK data will be     reviewed prior to each dose escalation. The dosing schedule in Part A may be adjusted to     expand a cohort or to add an additional cohort(s) in order to further evaluate additional     doses or repeat evaluation of a dose level already studied. Part B will be a randomized     placebo controlled, parallel group study. It will include three cohorts of 12 subjects each.     Each subject will receive repeat doses of GSK2849466 over 14 days. The doses chosen for Part     B will be based on the safety, tolerability, and PK data from Part A. Subjects in Cohort 4     (and/or an another cohort [s] as determined based on Part A PK data) will be dosed in the     fasted state on Days 1 and 14 and in the fed state on Day 7 when subjects will receive a     standard meal 30 minutes prior to dosing. Part B will provide sufficient safety and     tolerability data to bridge to longer duration studies. The study duration, including     screening and follow-up, is not expected to exceed 70 days for subjects in the study.   "
121421|NCT01696591|"     The purpose of the study is to determine the long-term safety and exploratory efficacy of     NEUROSTEM®-AD, administered via an open brain surgery to subjects with dementia of the     Alzheimer's type, who were eligible for and enrolled in the earlier part of the phase I.     Aside from the subjects who completed the earlier part of the Phase I, 3 additional subjects     with comparable demographics and disease characteristics as the treatment group will be     enrolled into a control group, followed-up for 3 months, and compared for various disease     progression indicators with the treatment group.      The hypothesis is that NEUROSTEM®-AD is safe and effective in the treatment of dementia of     the Alzheimer's type.   "
121422|NCT01696578|"     This study will measure the effects of biofeedback supported cognitive behavioral therapy     (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in     Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims     of torture and massive violence with available rehabilitation practice and integrate them     into the community. It is also our objective to build local knowledge and expertise to apply     measurement principles and CBT methods in the Balkan region.   "
121423|NCT01696565|"     The objectives of this Phase I/II study are:        1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy          receiving chemotherapy and to define a Study Dose for Phase II.        2. To evaluate the hematopoietic and immunological responses after administering of PG2.          Primarily to study the biological response of PG2, defined as WBC count in this study,          and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.   "
121424|NCT01696552|"     A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty     and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise)     using the Vanguard Total Knee System (Biomet)   "
121425|NCT01696539|"     The purpose of this study is to determine whether sustainable daily physical activity is     effective in improving biological indicators of health and self-reported quality of life in     men with prostate cancer.   "
121426|NCT01696526|"     The aim of this study is to investigate the bioavailability of conventional and vitamin D     fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.   "
121427|NCT01696513|"     The primary objective of this study is to determine whether the use of standard treatment in     conjunction with suction will improve acne scars compared to a standard treatment alone.   "
121428|NCT01696500|"     Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were     confirmed based on the investigators national diagnostic criteria. Patients who meet all     inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01     (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy     of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be     evaluated the disease evaluation score et al.      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse     events by 20 days after the start of the study treatment.   "
121429|NCT01696487|"     The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH),     cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and     treatment options are limited. Fructose overconsumption has been associated with gut     permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced     intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment     of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of     intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis     of intestinal biopsies. Findings in volunteers will be compared with liver patients     undergoing study procedures without fructose challenge. Translational in vitro experiments     will explore cellular responses to fructose and endotoxin. This project should provide novel     insights into dietary induced alterations of the gut integrity in progression of NAFLD to     NASH.   "
121430|NCT01696474|"     This multicenter, phase II, open label study will enroll patients with chronic cold     agglutinin disorder. A single course of Bortezomib will be given at the dose of 1,3 mg/sqm iv     on days 1, 4, 8, 11.   "
121431|NCT01696461|"     This is a Phase II, open-label, two strata, multicenter, prospective study of     plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological     malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor     for this purpose.   "
121443|NCT01696305|"     This study is a randomized, double-blind, active controlled phase 3 trial in the patients     with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the     patient with the past history of thyroid surgery).      An eligible patient will be randomized and allocated to either the test group (Hyalobarrier)     or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in     detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for     12weeks.      During the study, both the patients and the observer for the primary and secondary efficacy     evaluation will be masked.      Non-inferiority of the test device (Hyalobarrier) compared to the reference device     (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal     esophageal transit.   "
121444|NCT01696292|"     This study aims to shed light on the theoretical concept of mental flexibility and its     manifestation in adolescents following frontal lobe damage, and to develop a test battery for     young Hebrew speakers.   "
121432|NCT01696448|"     Though medical treatment has been effective in the treatment of cardiometabolic diseases     (including coronary atherosclerosis and diabetes mellitus), the incidence of these disorders     continues to be high. Many reasons are responsible, but lifestyle changes, including an     increased prevalence of obesity and the metabolic syndrome, are significant for this cause.     Diagnosis and treatment of obese patients with hypertension requires that health care     providers address the issues of hypertension, glucose intolerance, body weight and     dyslipidemia. A sedentary lifestyle and poor cardiorespiratory fitness are not only     associated with the (cardio) metabolic syndrome but could actually be considered features of     the metabolic syndrome. These issues are significant in the health of certain individuals,     who experience greater difficulty in treated BP control, experience increased hypertensive     and diabetic complications, and have higher levels of obesity.      In this study, the investigators will evaluate the efficacy of the nutritional supplements     berberine, alpha-lipoic acid, and picrorhiza (CAR-191) when consumed 30 minutes before meals,     on appetite suppression, body composition and weight control. Additionally, the investigators     will evaluate the effects of this combination of nutraceuticals on the mechanistic effects of     oxidation, inflammation, and vascular function in a high-risk population with the metabolic     syndrome.      Primary Objective To assess the comparative effect of a combination (known as CAR-191) of     berberine (200 mg), alpha-lipoic acid (150 mg), and picrorhiza (100 mg) three times a day,     compared to placebo three times a day, on parameters relate to appetite suppression, weight     control and body composition in a high risk population with the metabolic syndrome.      Secondary Co-objectives      To evaluate the effects of CAR-191 versus placebo on changes in:        -  Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound        -  Biomarkers including IL-6, HOMA-IR, HbA1C, hsCRP, adiponectin, plasma/urine          isoprostanes, PAI-1, TNFα-II, aldosterone, and glutathione redox ratio        -  Urinary protein excretion        -  Clinical chemistry including plasma glucose, blood urea nitrogen, creatinine, total          bilirubin, uric acid, transaminases (SGOT/AST, SGPT/ALT), alkaline phosphatase,          C-reactive protein, and lipoproteins   "
121433|NCT01696435|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses. This ancillary study is being conducted among participants in VITAL and will     examine whether vitamin D or fish oil: 1) reduces risk of clinical depressive syndrome, 2)     yields better mood scores over time, compared to placebo.   "
121434|NCT01696422|"     This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical     trial to evaluate the safety and immunogenicity of a attenuated tetravalent lyophilized     dengue vaccine manufactured by Butantan Institute. Three Clinical Sites at University of Sao     Paulo - Brazil will participate in the study. A total of 300 volunteers will be recruited and     divided into two steps: Step A (with no previous exposure to dengue) and Step B (with and     without previous exposure to dengue). In step A the participants will be assigned to receive     either the lyophilized vaccine, or the liquid vaccine(developed at NIH and produced and     formulated at Butantan according to the NIH-Protocol), or the placebo. In Step B participants     will be assigned to receive either the lyophilized vaccine, or the placebo. Both vaccine     formulations (lyophilized and liquid) are composed of the same attenuated viruses: rDEN1∆30,     rDEN2/4∆30(ME), rDEN3∆30/31, and rDEN4∆30. At the end of the study, 20 volunteers will have     received the liquid formulation (NIH), 210 the lyophilized formulation (Butantan), and 70     will have received the placebo. All participants included in both steps will be followed by a     period of five years after their inclusion in the study. The study hypothesis is that the     investigational lyophilized dengue vaccine manufactured by Butantan Institute is safe and     confers balanced immune response, after one dose of 1000PFU, to all for vaccine viruses.   "
121435|NCT01696409|"     Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in     adults in the United States. Vitamin D deficiency has been connected to many chronic health     diseases. The goal of this innovative research is to identify how vitamin D is able to have     such wide ranging health benefits. This study will determine which genes are turned on and     turned off in adults who receive 2000 IU vitamin D3 per day compared to 400 IU vitamin D3 per     day. Results should provide important new insights about the health benefits of vitamin D for     adults.   "
121436|NCT01696396|"     This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose study     to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of     subjects in remission (CDAI score < 150) at week 8 (primary endpoint). After completing all     screening assessments and meeting all eligibility criteria, subjects will be randomized to     receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 80% of     subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the     double blind period, subjects will enter an open-label period during which all subjects will     receive open-label AMG 181 at a single dose level according to protocol. Subjects who fail to     achieve minimal improvement, or experience disease worsening after initial response are     eligible to enter the open-label period early beginning at week 12 or after. Subjects that     complete the open-label period or early terminate from the study will enter the 2 year safety     follow up period.   "
121437|NCT01696383|"     The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost     0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian     glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure     (IOP) is uncontrolled while on their current treatment.   "
121438|NCT01696370|"     Hypertrophic cardiomyopathy (HCM) is a common inherited heart condition that causes     breathlessness, chest pain and fatigue. There are few treatments available. The investigators     have recently shown that a drug called perhexiline reduced symptoms and improved exercise     capacity in patients with HCM. This change appears to be driven by alterations in myocardial     energy metabolism. The aim of this trial is to test a similar drug, trimetazidine, in a group     of symptomatic patients with non-obstructive HCM.      HYPOTHESIS: trimetazidine will improve symptoms, peak oxygen consumption, cardiac function     and arrhythmia burden in medically refractory symptomatic patients with non-obstructive HCM.   "
121439|NCT01696357|"     This study will examine an innovative strategy to monitor asthma symptoms by using existing     technology to develop a non-invasive device for monitoring asthma symptoms in adolescents.     Using an iPod as a platform, and current sound data analysis techniques, a prototype device     will be developed that will directly monitor the chosen parameters of asthma symptoms,     including wheezing, coughing and activity levels. This small non-invasive device will be     continuously carried by or placed in close proximity to the adolescent on a daily basis. It     is hypothesized that such a device would be acceptable to adolescents and would lend accuracy     and objectivity to symptom assessment; something that existing monitoring strategies have yet     to achieve. It will also stimulate the adolescents' partnership in asthma self-monitoring and     ultimately lead to effective asthma management.   "
121447|NCT01696253|"     Over the past 30 years much has been learned about the molecular genetics and natural history     of familial forms of hematuria. However, enhanced understanding of these conditions has yet     to generate effective therapies for Alport syndrome(AS), the form of familial hematuria     associated with end-stage renal disease. Males with AS inevitably develop end-stage kidney     failure, with a 50% likelihood of dialysis or kidney transplantation by age 25 years. There     is no proven treatment for AS, although studies in animals have suggested several promising     potential therapies. Pharmacological or biological treatments that might delay or prevent the     development of kidney failure exist, but need to be evaluated through clinical trials.     Researchers interested in implementing clinical trials in AS will face several challenges,     the foremost of which is the relative rarity of the disease, necessitating aggressive efforts     to identify and recruit potential subjects for multi-center collaborative clinical trials.     The Alport Syndrome Research Collaborative (ARC) was established in 2009 as a partnership of     the Alport Syndrome Treatments and Outcomes Registry (ASTOR), the European Alport Registry     and centers of AS research in Canada, China and France with the objective of testing     potential treatments to delay or prevent terminal renal failure in people with AS. In this     feasibility study the five ARC centers will interrogate existing AS registries and databases,     and monitor accrual of new AS cases over an 18-month period, in order to quantify subjects in     the disease categories of interest. As part of this project we will examine the utility of     urinary uromodulin excretion as a marker of kidney injury and potential trial endpoint in AS     clinical trials. Our goals are to (1) demonstrate that participating centers have access to     sufficient numbers of males and females with AS to populate adequately-powered clinical     trials focused on two clinical targets, microalbuminuria and overt proteinuria, and (2) to     test the hypothesis that in males with AS urinary uromodulin excretion decreases as     albuminuria and proteinuria increase and that uromodulin offers an independent and insightful     measure of renal fibrosis and response to therapy.   "
121448|NCT01696240|"     The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5     inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with     mild pulmonary hypertension.   "
121449|NCT01696227|"     Background:      Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children.     Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure,     pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has     not shown improvement of the risk of these diseases, and contributes to the growing public     health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the     bowel. In an effort to reduce the number of UTIs, investigators want to exchange the bacteria     living in our bowels for a more harmless variety.      Hypothesis and specific aims:      Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel     bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing frequency     of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract     problems that require use of catheters to empty their bladders.      Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species,     Enterococcus species, and Klebsiella species to live in the same environment with the     probiotic bacteria to see how the numbers of each bacteria change.      Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge     them to live in the same environment as the probiotic bacteria.      Potential Impact:      This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless     bacteria and reduces the use of antibiotics overall in the community.   "
121450|NCT01696214|"     The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of     implementing the provisional design of the full scale TOM trial (e.g., the six month     treatment period, the impact of the smoking cessation intervention).      There is no active hypothesis for the Vanguard Protocol.   "
121451|NCT01696201|"     Due to physical and physiological changes that occur in pregnant women, depression is very     common during this period. Recent research findings indicate that antenatal maternal mood     state impacts on babies health. Nowadays, many researchers are focussed on examining the     effects of physical exercise on foetal and maternal outcomes.      The main aim of this study was to assess the effectiveness of a supervised exercise program     consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises     (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the     prevention and treatment of depression in pregnant women. Additionally, the other purpose of     the study was to analyze the effects of depression and physical exercise on outcomes.      Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a     better mood state than pregnant women who are sedentary, without having any negative effect     on outcomes.   "
121452|NCT01696188|"     This is a randomized, double-blinded, prospective study designed to compare two approaches     (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing     an interscalene nerve block and catheter for pain control after open shoulder surgery. Both     approaches have been used successfully but neither has been proven to be superior. Our     endpoints are pain scores, time for block placement, and catheter dislodgements. We     hypothesized that patients with the out-of-plane approach would have decreased pain and fewer     catheter dislodgements.   "
121453|NCT01696175|"     Observational multicentre cohort study. Children admitted to a Dutch PICU are studied for     lactate levels and ScvO2. Children instrumented with arterial and central venous catheters     are included within the first 12 hours after admittance.   "
121454|NCT01696162|"     This is a clinical research trial to evaluate the efficacy of delivering exercise therapy for     knee pain via the Internet utilizing an algorithm designed to adjust a home exercise program     based on user input. The investigators hypothesize that exercise therapy can be delivered     safely and effectively with increased participant satisfaction compared to the current     standard.   "
121455|NCT01696149|"     The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous     electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic     skin response (SSR) and skin temperature.   "
121456|NCT01696136|"     The MYSTIC_PAF trial investigates the differences between treatment with a single-tip     catheter against a multielectrode catheter in cardiac ablation procedures in patients with     paroxysmal atrial fibrillation.   "
121457|NCT01696123|"     Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer     disease (AD) offer limited and often transient symptomatic benefits to patients but do not     mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate     Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate     Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with     Rivastigmine.   "
121718|NCT01692834|"     To compare the bioavailability, pharmacokinetic profiles and the tolerability of two     formulations of intravenous cyclosporine in healthy volunteers.   "
121458|NCT01696110|"     The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three     antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or     unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.      All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of     the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.   "
121459|NCT01696097|"     The purpose of this study is to determine if the source of dietary protein (pork or     chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high     blood pressure.   "
121460|NCT01696084|"     To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients     (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint     will be overall survival.   "
121461|NCT01696071|"     Determine the 24-hour FEV1-profile of tiotropium solution for inhalation after 4 weeks     treatment periods of 5 mcg tiotropium administered once daily in the evening and 2.5 mcg     tiotropium administered twice daily (morning and evening). In addition compare the 24 hours     pharmacokinetic profile of 5 mcg tiotropium administered once daily and 2.5mcg tiotropium     administered twice daily in pharmacokinetic sub-investigation.   "
121462|NCT01696058|"     The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily,     orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and     tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium     (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.   "
121463|NCT01696045|"     The purpose of the study is to comply with the Pediatric Investigation Plan requirements of     Ipilimumab   "
121464|NCT01696032|"     A 2-part, Phase 1-2 controlled, open-label, randomized study in patients with     platinum-resistant recurrent ovarian cancer. In Part 1, patients will receive SGI-110 and     carboplatin. The optimum dose will be identified in Part 1 based on safety and efficacy. In     Part 2, patients will be randomized to receive the dose identified in Part 1 plus carboplatin     or one of three treatment of choice at the discretion of the investigator. The treatment of     choice consists of topotecan, pegylated liposomal doxorubicin, or paclitaxel.   "
121465|NCT01696019|"     A pilot randomized clinical trial was conducted in a random sample of 120 non-demented     Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the     effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no     intervention with respect to change in cognition and whole brain volume determined by     repeated neuropsychological batteries and MRI scans. Aims included determining the     feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as     well as collection of preliminary data on the efficacy of the interventions. The long-term     goal of this research program is to determine whether sustained physical and/or mental     exercise interventions are efficacious in delaying the onset of dementia and to understand     the role and mechanisms of brain growth in this process.   "
121466|NCT01696006|"     The purpose of this study is to determine whether coronary perfusion computed tomography is     effective in the treatment of coronary artery disease.   "
121467|NCT01695993|"     216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who     expect to have nausea, will be entered. Participants will be randomized to one of three study     arms: Arm 1: Version 1 handout; Arm 2: Version 1 handout + Version 1 relaxation MP3 +     acupressure bands; Arm 3: Version 2 handout + Version 2 relaxation MP3 + acupressure bands.      Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in     controlling chemotherapy-induced nausea   "
121468|NCT01695980|"     The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with     modified retractor is used compared to use of an endotracheal tube (ETT) and non modified     retractor is used.   "
121469|NCT01695967|"     patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to     reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and     tonsillectomy. It will compare the amount of nasal congestion for each group with the idea     that it will be less if treated with turbinate cauterization. Assessments from baseline to 6     months post procedure will be compared between the two groups.   "
121470|NCT01695954|"     The main goal of this study is to determine how taking efavirenz affects the levels of     pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir     with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to     see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are     taken together and to see how taking pitavastatin affects the levels in the blood of     darunavir.   "
121471|NCT01695941|"     This phase I trial studies the side effects and best dose of alisertib and bortezomib when     given together with rituximab in treating patients with mantle cell lymphoma or B-cell low     grade non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does     not respond to treatment (refractory). Alisertib and bortezomib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     rituximab, may interfere with the ability of cancer cells to grow and spread. Giving     alisertib and bortezomib together with rituximab may be a better treatment for relapsed or     refractory mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma.   "
121472|NCT01695928|"     The low-energy extracorporal shockwave is a scientifically approved method to activate     respectively increase bone-turnover processes especially in orthopedic medicine. The aim of     this clinical study is to apply this effect in orthodontic dentistry and evaluate the     orthodontic tooth movement respectively miniscrew stability clinically.      This randomized clinical study is carried out in orthodontic patients undergoing space     closure therapy at the university clinic of dentistry. During this period the tooth movement     rate as well as the miniscrew stability are evaluated consecutively chairside.   "
121473|NCT01695915|"     The purpose of the study is to determine the diurnal variation of rectal diameter in healthy     and constipated children using transabdominal ultrasound.   "
121523|NCT01695265|"     Using the FEELBREATHE®, a nasal ventilatory restriction device, during an exercise test in     treadmill, produce physiological changes in patients with Chronic Obstructive Pulmonary     Disease (COPD).      These changes may improve strength and endurance of the inspiratory muscles and improve     exercise tolerance in these patients.   "
121474|NCT01695902|"     The primary objective of this study was to compare the efficacy of Test Product (Levosert)     vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood     loss volume in women with menorrhagia.      The secondary objectives includes physical and gynaecological examinations, vital signs,     clinical laboratory tests including hemoglobin and ferritin measurements, body weight and     spontaneously reported adverse events were analysed and compared between Levosert and Mirena®     treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various     periods of time. The residual amounts of LNG in the devices were finally measured after     withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were     compared between the two treatment groups. Contraceptive effect of Levosert was estimated by     Pearl Index.   "
121475|NCT01695889|"     The purpose of this study is to compare exposure to general anesthesia between cases with a     diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical     records. The investigators wish to explore if there is a relationship between exposure to     general anesthesia and the development of Alzheimer´s disease.   "
121476|NCT01695876|"     Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy     subjects   "
121477|NCT01695863|"     This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade     versus Movi Prep for outpatient colonoscopy.   "
121478|NCT01695850|"     The objective of this study is to evaluate the efficacy and safety of a Chinese herbal     proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western     medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive     TCM syndrome.   "
121479|NCT01695837|"     The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity     dietary counseling intervention provided by the primary care physician (PCP), in patients at     risk for cardiovascular diseases   "
121480|NCT01695824|"     The primary objective of this study is to assess combined end point (All stroke, Systemic     embolism, Cardiovascular death) between two groups.   "
121481|NCT01695811|"     The purpose of this study will be to determine optimal surgical technique for performing FLAK     including laser parameters, keratoplasty shape and suture technique in order to standardize     surgical technique and to collect safety and efficacy data. This will be compared to data of     patients with full thickness PKP to measure visual outcomes, refraction, astigmatism,     surgical methods and wound healing.   "
121482|NCT01695798|"     Chronic malnutrition is associated with lack of effective gut immunity which is a possible     explanation for why we see polio cases among a proportion of children who have received 7 or     more doses of OPV.Our proposed idea is to evaluate if IPV antigen given later in life may act     together to boost humoral and mucosal immunity in children belonging to low-income background     in Karachi who have moderate to severe chronic malnutrition (height for age Z score less than     -2SD). We also intend to compare eIPV + OPV with OPV only in non-malnourished infants at 9     -12 month of age. Thus, the proposed study is a combination of two trials, with study     population stratified by nutritional status, each with a reference arm (bOPV) and an     experimental arm (bOPV plus IPV).   "
121483|NCT01695785|"     Little is known regarding the relationship between perceived and physiological exertion in     adolescents. The purpose of this study is to investigate the association between     physiological and perceptual markers of effort during exercise and the relationship of these     markers to other health-related behaviors in healthy weight and obese adolescents.   "
121484|NCT01695772|"     This open-label, single arm, multicenter study evaluated the resection rate in participants     with colorectal cancer and previously untreated unresectable liver-only metastases after     adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting.     Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams     per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and     postoperatively, unless they experienced progressive disease or unacceptable toxicity.   "
121485|NCT01695759|"     To evaluate the clinical efficacy and immunogenicity of the drug test Eritromax ® - (rHuEPO     Blau) compared to drug Eprex ® (Janssen-Cilag rHuEPO) in the treatment of patients who have     anemia secondary to chronic kidney disease (CKD), during the correction through assessing the     change in hemoglobin levels.   "
121486|NCT01695746|"     This observational study will evaluate the use in clinical practice and efficacy of Mircera     (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients     not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible     patients will be followed for 24 weeks.   "
121487|NCT01695733|"     This clinical trial studies the best time to administer the influenza vaccine to patients     with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different     times relative to chemotherapy may affect how well it works to help the body build an immune     response and prevent influenza in these patients.   "
121488|NCT01695720|"     The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for     pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries).     The study will compare VSI's accuracy to MRI's in diagnosing the same injuries.      The hypothesis is the VisionScope Imaging system will be able to provide direct visualization     and diagnostic images of inside the joint capsule space without fluid distention in the knee.     This study will provide valuable feedback on the ability of the VisionScope system to provide     physicians with the information they need to make a definitive diagnosis.   "
121489|NCT01695707|"     Many patients with eczema (atopic dermatitis) have an inherent defect in their skin barrier     as demonstrated by high water loss. In laboratory conditions, studies have shown that     pioglitazone restores the skin barrier function in skin from eczema patients. The purpose of     this study is to determine if taking pioglitazone improves the skin barrier function in     people with eczema.   "
121490|NCT01695694|"     The purpose of the study is to test the feasibility, acceptability, and efficacy of an     adapted intervention that is theoretically and empirically guided by the     Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk     behavior among women who have experienced Intimate Partner Violence (IPV), as well as such an     intervention.   "
121491|NCT01695681|"     The purpose of this study is to determine the prevalence of previously undiagnosed coeliac     disease based on a health survey from Tromsø, Norway. Moreover, the health impact of     undiagnosed coeliac disease will be examined.   "
121492|NCT01695668|"     The purpose of this research is to:        1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have          been diagnosed with graft-versus-host disease (GVHD), which is a complication that may          occur after bone marrow transplant where the newly transplanted material attacks the          patient's body and may cause eye dryness.        2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the          process in GVHD before the patient undergoes bone marrow transplant.        3. Compare how well Lotemax works in decreasing the process in GVHD with an          immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of          this condition.   "
121493|NCT01695655|"     Corneal transplantation is the most commonly performed human tissue transplant worldwide.     Over 40,000 corneal transplants occur in the US each year. .      This study will determine specific corneal neovascularization (CN) patterns in human corneal     allograft recipients to determine the characteristics that worsen the prognosis for graft     survival. We will test the hypothesis that specific characteristics of CN are prognostic for     corneal allograft rejection.   "
121494|NCT01695642|"     Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed     for correction of myopia. There are very few studies that have been performed to evaluate     long-term outcomes after LASIK.      In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability     of visual outcomes and long-term effect on corneal morphology with in vivo confocal     microscopy. Clinical and corneal morphology outcomes will also be compared between patients     who had flaps created with the microkeratome and femtosecond laser.   "
121495|NCT01695629|"     Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal     evaluation that permits non-invasive imaging of corneal structures on the cellular level.     Precise anatomic characterization of corneal structures, including corneal nerves, can be     rapidly performed with high resolution.   "
121496|NCT01695616|"     The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone     combination in relieving the symptoms associated with Climacteric Syndrome.   "
121497|NCT01695603|"     Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain     capnia and oxgen partial pressure within predefined ranges in comparison to the control of     capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in     brain injured patients. Comparison of the numbers of alarms and required settings     modifications observed with each ventilatory mode.   "
121498|NCT01695590|"     To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for     patients with relapsed or relapsed/refractory multiple myeloma.   "
121499|NCT01695577|"     The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance     training on patients with dizziness and balance problems after traumatic brain injury.   "
121500|NCT01695564|"     Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In     the last two decades the number of hospitalizations for AF has increased two- to three-fold.     More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder     that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke     compared with those without AF.      This registry will collection information on two devices that are used to treat AF. The     WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices     on outcomes related to AF has not been studied. This study will look to compare the two     devices to see how the outcomes may vary.   "
121501|NCT01695551|"     Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the     lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal     electrical pathways located in the heart tissue. A standard procedure called a catheter     ablation has been used for several years to help correct these abnormal pathways and, in some     cases, improve or even eliminate the ventricular tachycardia.      During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate,     and oxygen saturation in your blood). If you choose to participate in this study we will also     monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your brain     during the ablation.      By doing this study, we hope to have a better understanding of patients' blood and oxygen     flow to their brain during an episode of Ventricular Tachycardia (VT).   "
121502|NCT01695538|"     Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term     inappropriate in medicine is commonly defined as a heart rate greater than 100 beats per     minute at rest or with minimal physiological challenge. IST is characterized by an increased     resting heart rate with an exaggerated response to exercise or stress.      Yoga has been used extensively around the world as an alternative medicine approach in     treating numerous chronic and debilitating diseases. Studies have been conducted in various     countries to determine the benefits of Yoga as therapy for these chronic diseases. Several     studies have confirmed that yoga can reduce anxiety and regulate the stress response.      Studies in the past have shown that Yoga relieves stress, one of the most common triggers for     the arrhythmia and increased heart rate in IST. Based on past studies we hypothesize that     patients with IST might benefit by practicing yoga. Yoga may also help in better rate and     rhythm control with yoga when employed in combination with usual medical arrangement.   "
121503|NCT01695525|"     Syncope is a common problem that many clinicians may encounter in various outpatient     settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self     limited episode of systemic hypotension. Patients are usually managed with education on     syncope, anxiety management, and coping skills.      It has been established that practice of Yoga could relieve stress and anxiety. In a     different study, they also found that Yoga positively influences cardiovascular function by     decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve     control over the autonomic nervous system and able to control functions like heart rate,     blood pressure and respiratory rate.      Based on the findings that Yoga relieves stress and reduces heart rate, the investigators     propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms     associated with these episodes.   "
121547|NCT01694953|"     This is a multi-center natural history study of MNGIE (Mitochondrial NeurogastroIntestinal     Encephalopathy). Patients will be followed over time to assess clinical symptoms. The     investigators hope to learn more about the disease of MNGIE as well as develop useful     measures of disease status for use in future clinical trials.      Additional clinical centers will be listed as they become available.   "
121504|NCT01695512|"     The aim of our prospective and multicentre diagnostic study is therefore to elucidate on the     sensitivity and specificity rates of these serologic markers in combination with molecular     tools (both an Aspergillus specific and a multifungal PCR based assay), as serologic mark-ers     are not pathogen-specific, and furthermore to define species-specific cut-off values for BDG     in BAL samples.      Additionally, if genomic material of Aspergillus fumigatus is detected by PCR in a clinical     sample, we investigate fungal DNA for point mutations in the cyp51A gene mediating     resis-tance against common mould-active triazoles with novel rapid, sensitive and specific,     non-culture-based PCR-assays and sequencing to optimize antifungal treatment as early as     pos-sible.   "
121505|NCT01695499|"     The aim of this project is therefore to explore on the clinical significance of analyzing     surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and     biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR     assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts     with pulmonary infiltrates.      As GM and BDG are not species-specific, three established and repeatedly published species     specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed     by our group will be investigated in combination with the serological tests in a multicenter     prospective clinical diagnostic trial.   "
121506|NCT01695486|"     The purpose of this study is to compare sedation monitoring by bispectral index and comfort     score during open muscle biopsies in children.   "
121507|NCT01695473|"     This is a phase II, study of BKM120 in patients with high-risk, localized prostate cancer.     Eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the     prostate to confirm high-risk disease and collect prostate tissue for analysis. Two weeks     after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at     this dose level orally once daily for 14 days prior to radical prostatectomy at University of     California, San Francisco. Radical prostatectomy will be performed on the day of the last     dose of BKM120 at day 14. No further drug will be tken after the radical prostatectomy.   "
121508|NCT01695460|"     The trial is primarily designed to investigate whether treatment with vitamin D may influence     migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve     as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in     the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means     of quantitative sensory testing, diaries and blood samples for measurement of vitamin D.     Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in     the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of     those biomarkers will change following the treatment.   "
121509|NCT01695447|"     The purpose of this study is to determine whether duct-to-mucosa is better than invagination     in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized     controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The     duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100     or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar     carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy     will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity,     reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better     than invagination.   "
121510|NCT01695434|"     To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in     subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24     months and compared to a reference population of healthy controls.   "
121511|NCT01695421|"     Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac     function for the remainder of their life and consequently require continuous medical     management and intermittent hospital admissions. Several investigations have demonstrated     that electrical muscle stimulation (EMS) produces positive physiologic and psychological     adaptations in patients with HF. However not all the EMS modalities were been evaluated on     this population or not even were tested based on present recognized gold standard clinical     parameters after a short period of treatment. The primary aims of the proposed study is to:     Determine the effect of a five week home based of three EMS modalities on prognostics     markers, perceived quality of life, muscle force and electrical activity in subjects     diagnosed with HF.   "
121512|NCT01695408|"     Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing     interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the mean     survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. As in     Europe data are limited on the characteristics and management of such patients, INSIGHTS-IPF     was initiated as a new registry that documents newly diagnosed (incident) and prevalent     patients with confirmed IPF diagnosis prospectively.The registry will contribute to the     optimization of the management of IPF patients in the long term.   "
121513|NCT01695395|"     Quality of mental health services provision for adults with intellectual disability and     comorbid mental disorder is considered inadequate and therefore in need of further     improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study     therefore aims to compare mild and moderate intellectual disabled adults with a comorbid     mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid     mental disorder with respect to clinical parameters. The MEMENTA-study is an observational,     epidemiological, cross-sectional study. A representative sample of the target population is     realised by the assessment of approximately n=600 intellectual disabled adults working at     specialized facilities (sheltered workshops). A cluster sampling with probability     proportional to institution and size (n of overall employed persons) will be followed by a     simple random sampling of persons of these clustered facilities. A number of parameters such     as severity of mental health impairment, needs for care, quality of life (QoL), caregiver     burden, health services utilization, and costs for care will be assessed by using a set of     well-established standardised instruments. Quality of mental health care will be assessed and     examined by open questions to intellectual disabled adults with a comorbid mental disorder as     well as informal caregivers and staff of caring institutions.   "
121548|NCT01694940|"     The North American Mitochondrial Disease Consortium (NAMDC) maintains a patient contact     registry and tissue biorepository for patients with mitochondrial disorders.   "
121514|NCT01695382|"     Palliative care is a priority area of focus for health care in an aging population     experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative     care, access remains limited, especially in poor urban and rural settings. Cultural and     linguistic barriers may also increase disparities in palliative care for Latinos. Due to a     nationwide shortage of palliative care providers and the unique cultural preferences and     values of patients, the investigators are testing a patient navigator intervention to improve     palliative care outcomes for Latinos with advanced cancer.   "
121515|NCT01695369|"     Evaluation of Comfilcon A and Senofilcon A Lenses   "
121516|NCT01695356|"     Melasma is an acquired discoloration of the skin characterized by brown colour changes     commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The     control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV     sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible     light sunscreen. Visible light has melanotic properties and avoiding it can be part of the     treatment for melasma patients. The estimated number of subjects to be recruited and     randomized for the study is at least 25 per group. The purpose of this study is determine if     there is a difference in the improvement between these two sunscreens types. Melasma Area and     Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8,     and 12. Photographs, colorimetry and histological assessment will be also evaluated.     Occurrence of adverse effects will also be recorded.   "
121517|NCT01695343|"     The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway     anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway     infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway     Pa infection will be safe and well-tolerated, and will increase the time-to-need for     antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and     symptoms compared with placebo.   "
121518|NCT01695330|"     This is a phase 2, multicenter, open label, nonrandomized study for patients with MM who will     receive treatment with a SC bortezomib-containing combination regimen that does not contain     thalidomide or vincristine. The patients will be required to have received a prior IV     bortezomib containing combination regimen that did not contain thalidomide or vincristine and     that differs from the SC bortezomib-containing one. In between the time that the patient     received the IV bortezomib-based combination regimen and enrollment onto this study, patients     may have received other non-bortezomib-based regimens as long as these treatments did not     contain thalidomide or vincristine. This study will enroll patients who have relapsed or have     become refractory to their prior IV-administered bortezomib-containing combination regimen as     demonstrated by progressive disease while on or following that regimen. Patients must have     received 4 doses of a minimum of 1.0 mg/m2 of bortezomib administered IV in no more than 4     weeks per cycle. Patients must have received at least one cycle meeting this definition and     have shown progressive disease to be considered eligible. Patients who have relapsed or have     become refractory to their most recent IV bortezomib-containing combination regimen are     eligible regardless of when they received that regimen, as long as they meet the above     criteria.      The study will consist of a screening period, followed by up to eight open label treatment     cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a     follow-up period.   "
121519|NCT01695317|"     Traditionally, beta blockers have been used for migraine prophylaxis, but in later years also     antiepileptic drugs. Contraindications and side effects have to some degree limited their     use, and new prophylactics that can be used by most migraine sufferers and with little side     effects are in demand. One product that may seem to fulfill these requirements is     Acetyl-L-carnitine, which is a dietary supplement and naturally occurs in plants and animals.     L-carnitine is necessary for fatty-acid metabolism and energy production.      To our knowledge, no placebo-controlled studies have previously evaluated the efficacy of     Acetyl-L-carnitine in adults with migraine.      The aims of the present study is to evaluate the efficacy of Acetyl-L-carnitine as a     prophylaxis in migraine patients   "
121520|NCT01695304|"     The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden     of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very     young children are given drinking water or water is used in reconstitution of their food. We     hypothesize that ceramic water filters will remove Cryptosporidium from drinking water     reducing infection in infants.   "
121521|NCT01695291|"     This study will examine the feasibility and potential efficacy of augmenting SRIs with     minocycline. The study will assess whether the addition of minocycline leads to measurable     changes in striatal glutamate (Glu) levels. This study will recruit up to 45 youth ages 8-20     diagnosed with clinically significant OCD who have demonstrated no more than minimal response     to SRI treatment and are currently on a stable dose of SRI medication for at least 12 weeks.     Participants will be randomized to receive either 12 weeks of minocycline treatment or pill     placebo. Randomization will be 2:1 so that 2 of 3 participants receive minocycline. Screening     for eligibility will take place for 1-4 weeks. Participants will undergo MRS scans to measure     striatal Glu levels prior to randomization, and again immediately following the treatment     period. During the treatment period, participants will meet initially weekly and then every     other week with the study psychiatrist. All participants will be offered three months of open     medication treatment following participation. The clinical trial will only be conducted at     NYSPI and the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI.   "
121522|NCT01695278|"     Diabetes poses a substantial burden to racial/ethnic minorities and in populations with     limited access to healthcare. However, there is a shortage of healthcare providers available     to help patients adopt the lifestyle changes required for diabetes control. The goal of the     present study is to evaluate the feasibility and effectiveness of a diabetes self-care     intervention delivered by medical students to patients with poorly controlled diabetes.     Training medical students to use proven communication techniques to help patients identify     and overcome barriers to adopting lifestyle changes in diabetes is a novel but plausible     strategy. The investigators anticipate that findings from our pilot study will be used to     develop a larger study to definitively test the program's effectiveness. A long-term benefit     of our program is that future healthcare providers are practicing the skills needed to     promote positive lifestyle changes and provide care for chronic conditions in diverse     communities.   "
121524|NCT01695252|"     Providing feedback on patient progress to therapists improves clinical outcomes for patients,     particularly those who are failing to improve with therapy. The encouraging research has been     carried out by a small group of researchers, largely working in the United States health care     context. The samples studied have been young people attending university counselling     services, suffering from mild mental health disorders. The group studies are therefore not     similar to patients seen for psychological therapy in the NHS. Also given that therapists are     not necessarily alert to treatment failure, have an overly optimistic view of their patients     progress even when provided with evidence to the contrary, clinical supervision may be a more     effective method through which to provide patient informed clinical outcomes than directly to     therapists themselves.      We will assess if providing feedback through the supervision process is more effective than     providing this information to therapists themselves in terms of improving clinical outcomes,     particularly for patients who are failing to improve with routine NHS Psychological therapy.   "
121525|NCT01695239|"     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo     in participants with active psoriatic arthritis.   "
121526|NCT01695226|"     Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is     evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further     determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the     changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor     celecoxib.      In a single-centre double-blinded phase II study, breast cancer patients were randomised to     receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three     weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical     excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray,     which allows to study the genome-wide changes at the transcriptional level.   "
121527|NCT01695213|"     Thr purpose of this study is to compare the clinical and radiological results, as well as the     femur bone density measurements of two uncemented total hip prostheses during 5 years of     follow up.   "
121528|NCT01695200|"     This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in     reducing the severity of autism and its comorbidities.   "
121529|NCT01695187|"     This is a study to test the hypothesis that time to healing of a cold sore will be lower in     the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a     history of cold sores will be enrolled and administered active treatment or placebo in a     blinded manner. Subjects will then be followed to assess time to healing.   "
121530|NCT01695174|"     In the current protocol, we propose the assessment of potential beneficial effects of the     antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15     adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice     daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or     equal to 40 kg will receive Xifaxan, 550 mg twice daily.   "
121531|NCT01695161|"     The aim of the present study is to compare intraocular pressure (IOP) values assessed with     Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann     applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want     to investigate biomechanical characteristics of the cornea and their influence on the     IOP-measurements.   "
121532|NCT01695148|"     The purpose of this cluster-randomized trial is to examine whether daily consumption of     β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and     improve the vitamin A status and among 4-8 year old children in rural Zambia.   "
121533|NCT01695135|"     The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when     co-administered with prednisone in Asian patients with metastatic castration-resistant     prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.   "
121534|NCT01695122|"     The purpose of this study is to evaluate if the addition of valproic acid to standard     platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck     squamous cell carcinoma can improve treatment outcomes, such as response rate.   "
121535|NCT01695109|"     Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1)     mimetics in comparison to DPP-4 inhibitors. A possible mechanism of this effect might be     associated with changes in food choices, as suggested by animal studies. It has been shown     that functional magnetic resonance imaging (fMRI) of the brain is a valuable tool in obesity     research and can be used to study the response of several brain regions to the visual     presentation of preferred in comparison to non preferred food items and to non food items The     aim of this study is to search for possible effects of liraglutide in comparison to placebo     on 1. food choices and 2. changes in brain function as evidenced by fMRI in healthy     volunteers.      Findings of this study will help not only to get deeper insight into the mechanism of the     anorexic effect of GLP-1 mimetics, but also into the regulation of food choices per se. In     the future, it is planned to extend the results of this study in normal weight volunteers to     obese diabetic subjects.   "
121536|NCT01695096|"     To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly     ongoing pregnancy rate between high humidity incubators and humidity free incubators   "
121549|NCT01694927|"     The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells     intralesional transplantation as a safe and potentially beneficial treatment for patients     with spinal cord injury.   "
121550|NCT01694914|"     At present, all commercially available corneal organ culture media contain foetal calf serum     (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for     corneal cell survival but are problematic because they theoretically have risk of     anthropozoonosis transmission, especially for new variant of CJD and the variability between     FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo     validation of a new medium free compound animal. We proved its superiority over conventional     medium containing 2% FCS for endothelial cell survival during the storage time. The goal of     this clinical trial is now to assess its superiority in patients.   "
121551|NCT01694901|"     This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic     (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to     optimized outcome compared to manually controlled clinical anesthesia and computerized     Electroencephalogram (EEG).   "
121537|NCT01695083|"     Abstract:      Fatty liver most frequently corresponds to a fat overload of the liver. It is usually     classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic     fatty liver overload, the histological spectrum ranges from simple steatosis to     steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression     to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these     hepatic lesions is difficult especially as they may exist while the liver tests are normal.     The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to     the risk of hemorrhagic complications.      Number of subjects required:      According to the literature and data collected Louis Mourier in the recent years, the     inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and     steatohepatitis. All patients will be included in Louis Mourier hospital.      Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total     duration of participation for a patient will be one month.      Methodology:      It is a monocentric, prospective study evaluating the value of noninvasive tests for the     diagnosis of hepatic lesions in morbid obese patients. The open  MRI system allows access     to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in     France and liver pathology can be explored only on the system of Louis Mourier.      The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP,     and serum tests.      Examinations required specifically for research Examinations required specifically for the     research is abdominal MRI, FibroScan/ CAP and serum tests.      Primary endpoint :      To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe     steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of     these tests are calculated. The gold standard is the result of histology on liver biopsy,     with a morphometric study of these parameters. ROC curves are used to determine the best     compromise between sensitivity and specificity.      The secondary endpoints were:      Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form     of three variables of interest: quantification of the surface of the visceral fat, of     subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal   "
121538|NCT01695070|"     Intrauterine growth restriction is the term used to describe a condition where an unborn baby     does not reach its optimum size. In the short and long term, intrauterine growth restricted     babies have a higher risk of serious disease and even death. It is well established that very     low levels of oxygen in the baby's blood can harm the baby's health through a state known as     oxidative stress. Currently, there is no established treatment available to treat     intrauterine growth restriction or its complications. In experimental animal studies however,     the naturally occuring hormone, melatonin, has been shown to significantly reduce oxidative     stress and improve health of the unborn babies that have suffered from intrauterine growth     restriction. This study aims to find out if the use melatonin twice per day throughout     pregnancies affected by intrauterine growth restriction will lower the level of oxidative     stress experienced by the unborn baby. If this is the case melatonin may help protect the     unborn baby from damage caused by oxidative stress, this will be studied in a separate future     study.   "
121539|NCT01695057|"     This pilot clinical trial studies vorinostat before surgery in treating patients with     triple-negative breast cancer. Vorinostat may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Giving enzyme inhibitor therapy before surgery may     make the tumor smaller and reduce the amount of normal tissue that needs to be removed   "
121540|NCT01695044|"     PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and     tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two     groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group     comprises subjects who must have received at least one taxane-containing chemotherapy regimen     (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic     chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and     progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to     Radium-223. Both groups of subjects must also have received and progressed on abiraterone     acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or     enzalutamide, Sponsor approval is required for participation in the study. Subjects will     receive up to eight doses of PSMA ADC approximately once every three weeks.   "
121541|NCT01695031|"     The objective of this study is to determine the feasibility of conducting a randomized     controlled trial to evaluate the effectiveness of an online, Emergency Department-initiated     asthma management intervention designed to reduce asthma-related morbidity among urban     teenagers aged 13-19 years with uncontrolled asthma. The study will examine issues around     recruitment, participant compliance with the study protocol, Internet access, and attrition.     Investigators will first develop a protocol for recruiting 13-19 year old patients with acute     asthma into an ED-initiated pilot trial of an online asthma management program, describing     recruitment and refusal rates. Investigators will measure participant compliance with the     pilot study protocol including 4 online sessions and a 6 month survey. Investigators will     also measure compliance of the participants parents at baseline and a six month follow up.     Investigators will then use pilot study results to describe the intervention effect on     selected outcomes including ED visits, asthma control as measured by Asthma Control     Questionnaire, functional limitations, quality of life, and behavior change.   "
121542|NCT01695018|"     The purpose of this study is to verify the function of p16 methylation diagnostic reagents in     early diagnosis of oral cancer.   "
121543|NCT01695005|"     The purpose of this study is to find a recommended dose level of LY3039478 that can safely be     taken by participants with advanced cancer or cancer that has spread to other parts of the     body, including but not limited to lymphoma. The study will also explore changes to various     markers in blood cells and tissue. Finally, the study will help to document any tumor     activity this drug may have.   "
121544|NCT01694992|"     The purpose of this study is to evaluate the effectiveness of a rehabilitation     (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in     general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability     at fourteenth and third month, functional improvement at third month, the frequency of deaths     and incidence of complications due to immobility and quantify the time spent in hospital.   "
121545|NCT01694979|"     The pelvic floor and diaphragm work together in many different functions. Two important     functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to     maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. The     investigators don't know how much the pelvic floor lifts and squeezes during different types     of breathing out. The purpose of this study is to measure pelvic floor lift and squeeze     during different types of breathing out.   "
121546|NCT01694966|"     Evaluation of the histologically proven adenoma and carcinoma detection rate in patients     undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with     200 mg of Methylene Blue MMX® tablets.   "
125069|NCT01647555|"     This study evaluates the skin toxicities in patients with epidermoid cancer, treated by     Radiotherapy in association with Cetuximab.   "
121552|NCT01694888|"     Midwives are responsible for documenting and keeping care facts in midwifery departments.     Inaccurate documentation or even minute error in reporting may lead to burdensome     responsibility for midwives. This study has been conducted aimed to compare midwifery     students' performance before and after teaching fundamentals of documentation. In this     quasi-experimental study, 28 midwifery students were participated. Data were collected by a     questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary     patient with physician order and a checklist contain 11 elements of documentation   "
121553|NCT01694875|"     The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System     in cervical cancer screening.      This objective will be accomplished in the ASC-US Study by evaluating the performance     characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women     with ASC-US Pap test results who were 21 years of age or older (≥21 years of age) at the     time of their Pap visit. For the Adjunct Study, this objective will be accomplished by     evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at     increased risk of cervical disease in a sample population of women with negative     (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.   "
121554|NCT01694862|"     The overarching aim of the Integra Initiative is to strengthen the evidence base on the     impact of integrating family planning (FP), postnatal care (PNC) and HIV services in     sub-Saharan Africa. Specifically, in the study the investigators aim to test the following     hypotheses:      the provision of integrated services, compared to separate services, will:        1. lead to increased uptake of a range of SRH services .        2. attract a greater number and diversity of clients.        3. lead to increased quality of a range of SRH services        4. lead to healthier sexual and reproductive behavior.        5. lead to reduced stigma at health facilities.        6. lead to the more efficient use of resources, with a lower unit cost of provision of key          services.      For the purposes of this study integration is defined as offering clients both HIV and     postnatal care (PNC) or HIV and family planning (FP) services in the same visit.      To better understand how services can be integrated in different countries this study focuses     on two key models of integration in Kenya and Swaziland.        -  The first model focuses on integration of FP and HIV services (integrated FP model) and          entails performing HIV testing, STI screening and management, cervical cancer screening,          condom promotion within FP consultations, as well as active referral to antiretroviral          (ART) units for HIV-positive clients. The FP model will be evaluated in Kenya only.        -  The second model focuses on integration of PNC and HIV services (integrated PNC model)          and will be implemented in both Kenya and Swaziland. The model focuses on the provision          of PNC services to mother and baby, FP services, repeat HIV testing for mother, HIV          testing for infant and referral to HIV services for HIV positive mothers and infants, as          well as referrals for clients requiring other additional services.   "
121555|NCT01694849|"     Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting     from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis     and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is     considered as the most common form of chronic liver disease in adults in the United States,     Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the     adult population.      Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to     hepatic steatosis associated with inflammation and liver cell injury upon microscopic     examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and     deserves serious medical management. Up to now, there is no effective drug which has clearly     demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the     resolution of NASH.      In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the     treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with     the metabolic syndrome and type 2 Diabetes.      This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once     daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver     biopsy assessments.   "
121556|NCT01694836|"     Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to     assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula     alba (Birch) - versus placebo.   "
121557|NCT01694823|"     In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet     technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating     Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.   "
121558|NCT01694810|"     The study will assess safety and tolerability of different doses of topical gel containing a     new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of     healthy volunteers with high counts of Propionibacterium acnes. The test product will be     applied once daily for 4 weeks. Exploratory measures include whether the topical product     decreases the amount of a bacteria associated with acne (P. acnes).   "
121559|NCT01694797|"     The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol     Succinate Extended-Release Tablets 50 mg under fasting conditions   "
121560|NCT01694784|"     Most prevention efforts focus on promoting services (e.g. vaccination, screening tests).     While some of these services have clear net benefit, many instead have possible or clear net     harm. Currently, three quarters of services graded by the U.S. Preventive Services Task Force     (USPSTF) have possible or clear net harm (C, I, and D services). Many of these services are     delivered in healthcare settings at higher rates than what might be expected based on their     potential for harm. This leads to adverse outcomes, excess costs, and missed opportunities to     deliver more quality care. An important issue in delivering prevention messages is how to     shift toward a focus on the appropriateness of prevention: encouraging services with clear     net benefit and either discouraging or reducing demand for services with possible or clear     net harm. Unfortunately, little is known about what drives overuse of potentially harmful     screening services or how to make harms relevant to patients.      This randomized controlled trial (RCT) of 775 patients at 4 primary care practices aims to 1)     assess factors associated with intent to receive possibly or clearly harmful screening     services and 2) determine whether and how patients' plans to get screened change with various     presentations of information about harms (e.g. qualitative, quantitative, narrative, framed).     The investigators will focus on three types of screening services: osteoporosis screening     (previous C recommendation and now no recommendation for women < 65 years old with no     fracture risk factors), prostate-specific antigen (PSA) screening (D recommendation for all     men, regardless of age), and colorectal cancer (CRC) screening (C for ages 76-85).   "
121561|NCT01694771|"     The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily,     orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and     tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium     (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.   "
121562|NCT01694758|"     OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will     include patients suffering from diabetes type 2, treated or untreated, insulin dependent or     not insulin dependent.      In this study we aim to explore at a primary care level whether the use of benchmarking     against a set of guideline-based reference values on a patient basis, may improve quality of     patient care, in particular control of diabetes, lipids and blood pressure.   "
121563|NCT01694745|"     EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices     regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in     different countries in Europe. This study is conducted as part of the NeoOpiod study.      The main objective of this study is to determine the current clinical practices regarding the     use of sedative and analgesic drugs in newborns in intensive units in different countries in     Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation     and analgesia, the medications used for sedation and analgesia in ventilated neonates, the     length of use of medications administered for sedation and analgesia in ventilated neonates     and similarities and differences in sedation and analgesia practices among European     countries.      The secondary objectives are: a) to determine the proportion of neonatal units that have     developed and implemented local written guidelines to provide continuous sedation and     analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b)     to document the published guidelines for neonatal analgesia and sedation in different     European countries and develop consensus for common European standards that can be applied in     all medical settings, c) to determine the frequency of use of pain assessment tools in     ventilated newborn infants and evaluate their impact on pain management practices and d) to     determine practices to assess and prevent withdrawal syndromes.      The EUROPAIN STUDY is observational and therefore it will not interfere with routine     practices of participating units. No changes in diagnostic, therapeutic or any managing     strategy of patients are imposed by the participation in this study. This epidemiological     study will only collect data on clinical practices in each unit. It will include all neonates     up to a corrected age of 44 weeks post conception.      The maximum duration of data collection for every included infant is 28 days. Data collection     will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another     hospital). Data will be entered on a secure web-based questionnaire.   "
121564|NCT01694732|"     Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi     with an increasing prevalence. By 2020, the mortality related to COPD is expected to become     the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the     cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain     active smokers. Brittany is the second region of France facing an abnormal high death rate     related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the     evolution of the disease, the frequency of the exacerbations and the the mortality. Besides,     smoking cessation is associated with a reduced risk of cardiovascular events and cancer.     Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such     population. Furthermore, smoking cessation has been underestimated in several studies. Most     of these studies evaluated various methods of smoking cessation in COPD patients performed     after an exacerbation, which has a hospitalization related mortality of approximately 10%.     Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to     cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is     reported to be one of the most effective pharmacotherapies for smoking cessation. However, it     has never been evaluated at the acute phase of an exacerbation of COPD requiring     hospitalization.   "
121565|NCT01694719|"     The purpose of this study is to evaluate the potential effects of a cognitive training     program when combined with a particular form of psychotherapy (behavioral activation therapy)     for depression. Behavioral activation therapy targets changes in behavior as a method for     improving a depressed individual's thoughts, feelings, and overall quality of life. This     study is designed to test whether a computerized brain exercise called cognitive control     training can enhance the effects of a 5-session behavioral activation therapy program. CCT     has been shown to reduce depressive symptoms in two other studies, but it has not yet been     combined with behavioral activation therapy. The investigators hypothesize that individuals     assigned to the behavioral activation plus cognitive control training condition will     demonstrate reduced depressive symptoms from pre to post treatment compared with those     assigned to the behavioral activation plus computerized control condition. The investigators     hypothesize that these gains will be maintained at one-month follow up.   "
121566|NCT01694706|"     The primary objective of this trial is to investigate the effect of food and of gastric pH     increase on the relative bioavailability of faldaprevir.   "
121567|NCT01694693|"     Database analysis:        -  To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)        -  To describe joint population of Orencia        -  To assess the impact of the treatment on health status of the treated population as          assessed by morbid-mortality criteria        -  To describe therapeutic strategies and use of health services   "
121568|NCT01694680|"     The purpose of the I-TEAM project is to assess whether there is a change in visual function     and status of the retina after a year of intervention in subjects with early signs of     Age-related Macular Degeneration.   "
121569|NCT01694667|"     The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial     which will assess changes in hyperactivity in children ages five through eight with an autism     spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this     question, this study will assess changes in hyperactivity as measured by the Aberrant     Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity     who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo.     The overwhelming majority of study procedures, including recruitment, informed consent,     assessment of inclusion and exclusion criteria, and collection of baseline and outcome     measures will take place over the internet.   "
121570|NCT01694654|"     1. To determine the incidence, prevalence and long-term outcome of patients with SFTP in          the German spoken part of Switzerland.        2. To define the role of immunohistochemical and molecular techniques, such as          immunostaining, FISH and mutational analysis regarding their ability to predict          malignant behavior in terms of prediction of overall survival and disease-free survival.   "
121571|NCT01694641|"     A multiple pregnancy is an undesired outcome of assisted reproduction. Current embryo     selection technologies are inefficient in identifying the embryo with the highest     implantation potential. Time lapse (TL) embryo monitoring provides additional information     about embryo development and therefore may aid embryo selection. The investigators aim is to     study whether TL monitoring is superior to traditional embryo observation when a single     blastocyst is selected for transfer (ET).   "
121572|NCT01694628|"     The purpose of this study in patients with advanced COPD and depression is twofold:        1. Determine the feasibility and acceptability of a 6-session e-counseling intervention        2. Determine the efficacy of the e-counseling intervention on depressive symptoms      We hypothesize that patients who participate in e-counseling will have improved depressive     symptoms compared to patients receiving usual care at 8 weeks.   "
121573|NCT01694615|"     Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and     for surveillance in the diagnosis of acute rejection using standard transbronchial forceps.     It is recognized that standard forceps biopsies underestimate the presence or degree of     airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been     shown in the literature to provide larger samples without crush artifact in a safe fashion in     lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is     superior to standard transbronchial forceps biopsies in regards to sample size, architecture     and the diagnosis of early rejection in lung transplant recipients which if discovered     earlier may improve survival.   "
121574|NCT01694602|"     The overall aim of this research is to develop a non-invasive approach to evaluate the     production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining     which patients are at high risk for future development of cancer induced skeletal muscle     atrophy.      Rationale: The approach is based on the hypothesis that after an oral dose of deuterated     3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (> 12 hours     post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the     rate constant for myofibrillar protein degradation and can be determined from spot urine     samples.   "
121575|NCT01694589|"     We hypothesize that administration of LDE-225 in humans with pancreatic cancer will result in     inhibition of paracrine HH signaling in the pancreatic tumor stroma while having no effect on     autocrine signaling in the tumor cell compartment. Furthermore we hypothesize that treatment     with LDE-225 will result in changes in the tumor stroma (decreased desmoplasia, increased     vascularity) that will result in improved tumor blood flow.      The purpose of this study is to determine if, where and how LDE-225 works in pancreatic     cancer. A cancer cell's growth can depend on the cells and tissue around it. The cells and     tissue make chemical signals to influence the cancer's growth. This research study is     evaluating LDE-225 designed to interfere with one of the growth signals causing pancreatic     cancer growth.   "
121576|NCT01694576|"     By this clinical trial, the investigators are trying to give an answer to such a question.     Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and     platinum after concurrent chemoradiation?   "
121577|NCT01694563|"     The primary objective of this post-approval study is to evaluate the clinical outcomes in a     cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or     long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation     System by physicians performed the Maze IV procedure.   "
121578|NCT01694550|"     The aim of this study is to examine a correction term for an adapted QT interval during     ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting     for the QT intervals in various pacing conditions.   "
121579|NCT01694537|"     DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm.     This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major     proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight     Proteins (LLP). This enzym can be transported to the bloodstream via intestinal epitel.     Structure of DLBS1033 looks like lumbrokinase. Lumbrokinase is enzym that consist of 6     isoenzyme serine protease. As a drug that consists of serin protease enzym, suspected that     the mechanism of action of DLBS1033 similar with lumbrokinase, especially as plasminogen     activator in fibrinolytic system. In vitro study by Trisina et al showed that DLBS1033 has     fibrinogenolytic activities on fibrinogen α, beta, and gamma chain, decreasing platelet     aggregation and clotting time was prolonged. Until now, the mechanism of action and effects     of DLBS1033 on human fibrinolytic and coagulation system still unknown. Therefore, the aim of     this clinical trial is to evaluate the effects of DLBS1033 on human fibrinolytic and     coagulation system on healthy subjects.   "
121580|NCT01694524|"     Few studies dealing with the risk of infectious of nervous system and the utility of lumbar     puncture and of emergent neuroimaging among patients with simple febrile seizure between 3     and 11 months age and with complex seizure has been reported. None of these studies was     multicentric. Recommendations about management of these children are heterogeneous.      The investigators aim to study by an observational retrospective multicentric study the rate     of infectious of central nervous system among patients with a complex febrile seizure and     among patients between 3 and 11 months age with simple febrile seizure.   "
121581|NCT01694511|"     The purpose of this study is to determine whether High Resolution Magnification Endoscopy     (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to     conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic     epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients     with Barrett's Esophagus (BE).   "
121582|NCT01694498|"     The purpose of the study is to investigate the efficacy and safety of two different dose     levels of desmopressin orally disintegrating tablets against placebo for the treatment of     nocturia in adult men during 12 weeks treatment   "
121583|NCT01694485|"     This is a randomized, double blind, placebo controlled, parallel group, multiple dose study     to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of     subjects in remission (total Mayo Score < 2 points with no individual subscore > 1 point) at     week 8. After completing all screening assessments and meeting all eligibility criteria,     subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A     maximum of approximately 50% of subjects with any prior anti-TNF agent use will be allowed in     the study. At the end of the double blind period, subjects will enter an open label period     during which all subjects will receive open label AMG 181 at a single dose level according to     protocol. Subjects who failed to achieve a response at week 8 and also have an inadequate     response at week 12 or after are eligible to enter the open label period of the study early.     Subjects who achieved response and/or remission at week 8 and subsequently experience disease     worsening are eligible to enter the open label period early ONLY if a confirmatory     rectosigmoidoscopy confirms disease severity as defined by protocol. Subjects that complete     the open label period or early terminate from the study will enter the 2 year safety follow     up period.   "
121584|NCT01694472|"     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of     MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients,     such as malignant melanoma and lung cancer.   "
121585|NCT01694459|"     International guidelines support the use of a full-dose heparin (anticoagulants) during     coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances     in angioplasty techniques and the widespread use of pretreatment with two antiplatelet     agents.      Thus the investigators designed a study comparing safety and efficacy of standard dose     heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty     who are on aspirin and clopidogrel at the time of the procedure.   "
121586|NCT01694446|"     Increased postprandial plasma triglycerides are associated with increased cardiovascular     risk. Chronic consumption of carbohydrates is associated with increased levels of     triglycerides. Very few studies have assessed the effect of acute consumption of     carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present     study aims to assess the effects of acute administration of glucose and fructose on hepatic     and intestinal lipoprotein production.   "
121587|NCT01694433|"     The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene,     also known as Dovonex) on the face and on the bacteria that cause acne. The information     gained from this study may lead to new treatments for acne. In this study, Calcipotriene will     be compared with a placebo, a cream that looks like Calcipotriene, but contains no active     ingredients.   "
121588|NCT01694420|"     This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF     [Stribild] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV     Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and     study drug (ELV/COBI/FTC/TDF) will be provided for the first 48 weeks. After week 48,     clinical care but not study drug will be provided through week 96. A study participant     suppressed at week 48 can continue on FDC ELV/COBI/FTC/TDF.      The primary hypothesis is that once daily fixed-dose combination elvitegravir (ELV),     cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) will rapidly     reduce viral replication to <50 copies RNA/ml in participants with acute HIV infection. The     secondary hypotheses to be considered are 1) virologic response rates as measured by plasma     HIV RNA levels will be non-inferior or superior to a historical group of participants from     the PHI cohort treated with EFV/FTC/TDF, 2) compared to historical controls treated with     EFV/FTC/TDF, plasma HIV RNA will decrease more rapidly in PHI participants treated with     ELV/COBI/FTC/TDF, 3) compared to historical controls treated with EFV/FTC/TDF, immune     activation as measured by the proportion CD4+ and CD8+ cells expressing HLA-DR and CD38+ will     decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 4)in a subset of     participants samples will be obtained from compartments such as the gastrointestinal tract,     and lymphoid tissues to assess changes over time in parameters such as HIV-1 RNA, immunologic     responses to HIV, and tissue and anatomic reservoirs. We hypothesize that treatment with the     ELV/COBI/FTC/TDF will demonstrate improved viral clearance in these compartments as compared     to historical controls treated with EFV/FTC/TDF. 5) in a subset of participants who remain     suppressed on therapy, resting CD4 cells with replication-competent HIV-1 (latent reservoir)     will be quantitated and compared to similar measurements in PHI participants treated with     EFV/FTC/TDF. In addition, we will compare these results to those measured in HIV-1 infected     participants treated and 6) ELV/COBI/FTC/TDF will be well tolerated, and the proportion of     participants who require treatment modification will be less than that observed in     participants treated with EFV/FTC/TDF.   "
121589|NCT01694407|"     This prospective, double-blinded, randomized, parallel cohort study will examine the genital     and systemic safety, pharmacokinetics (PK), pharmacodynamics (PD), disintegration and     disappearance times, and acceptability of four vaginal tablets: 1) Tenofovir (TFV) alone; 2)     Emtricitabine (FTC) alone; 3) TFV combined with FTC; and 4) placebo. Participants will be     randomized to treatment group, to number of tablets to be inserted in the Single Use Phase (1     tablet or 1 tablet followed by a second tablet two hours later to mimic the BAT24 dosing     regimen), and to one of four collection time points (2, 4, 6, or 24 hours after tablet     insertion) for assessments only after the last dose of the Multiple Use Phase.      In the Single Use Phase of the study, the participant will insert one tablet in the clinic to     estimate times to disintegration and disappearance. Those randomized to two tablets will     insert a second tablet 2 hours later. In all women, sample collection will occur 5 hours     after the initial tablet insertion.      In the Multiple Use Phase of the study, participants will insert a tablet once daily for 14     days. The 1st, 7th, and 14th tablets will be inserted in the clinic; the remaining tablets     will be inserted at home. The clinic will call the participant on day 3 of the multiple use     phase to ask about any symptoms the participant may be experiencing. Each insertion in the     clinic will be followed by sample collection and, at Visits 4 and 6, colposcopy at the     participant's assigned time point.   "
121590|NCT01694394|"     The primary objective of the study is to determine the rate of detection of sub-clinical     atrial fibrillation (≥ 5 minutes)within an average of 12 months following implant of the St.     Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular     risk factors and left atrial enlargement, but without prior AF.   "
121591|NCT01694381|"     Single-chain urokinase-type plasminogen activator (pro-urokinase) is a highly effective     thrombolytic drug. At pharmacologic concentrations however, pro-urokinase is converted to     urokinase - a non specific thrombolytic, limiting its therapeutic use. Mutant pro-urokinase     (M5) is more stable and its conversion to urokinase is inhibited by C1-inhibitor.      The primary objectives of the study are:        -  To assess the overall safety and tolerability related to systemic plasminogen activation          of single doses of M5 over a wide dose range (study part I).        -  To assess the effect of single doses of C1-inhibitor on the overall safety and          tolerability of single doses of M5 and its effect on M5-induced coagulation changes          (study part II).   "
121592|NCT01694368|"     To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging     with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and     after percutaneous intervention   "
121593|NCT01694355|"     It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis     is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and     will cause low BMD estimation in DXA scan due to insufficient bone mineralization.      We assume that among these postmenopausal women, Vitamin D treatment will improve bone     mineralization and will cause a rapid increase in BMD. According to the results,     bisphosphonates therapy may be an unnecessary treatment.      The objective of this study is to evaluate the impact of severe vitamin D deficiency and its     correction on Bone Mineral Density (BMD) in postmenopausal women.   "
121606|NCT01694186|"     This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to     evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI)     insert for the management of subjects with non-infectious uveitis affecting the posterior     segment of the eye. Patients will be randomized to receive either a sham injection or the FAI     insert and will be observed for three years following treatment.   "
121607|NCT01694173|"     Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients     after the same have been labelled with positron emission tomography tracer F18-FDG; as it is     assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to     pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90     minutes of stem cell infusion.   "
121594|NCT01694342|"     Telomerase, through its regulatory function on telomere length may play an important role in     immune function, cellular replicative life span, and carcinogenesis. Non-alcoholic fatty     liver disease (NAFLD) is considered a benign condition, but in some cases, it may progress to     cirrhosis and hepatocellular carcinoma. The risk factors for that evolution are not fully     understood.      Our group showed in a previous study, that hTERT mRNA expression is lower in peripheral     lymphocytes of patients with fatty liver, compared to healthy controls. This finding could     explain the telomere shortening found previously in these patients by our group [20] and     others [21]. Furthermore, we found higher rates of TC in these patients, probably due to an     attempt to counteract the shortening of the telomeres and to stabilize them. This is through     a different mechanism that is not telomerase-mediated.      Telomere capture is considered an alternative way to maintain telomere length and chromosomal     stability [3]. It is a more common mechanism for chromosome stabilization and repair, in     contrast to the telomerase-mediated process of chromosome healing and elongation This study     aimed to evaluate mechanisms of telomere homeostasis like telomere shortening, telomerase     activity, telomere capture and aneuploidy in patients with NAFLD in order to explain previous     findings of telomere shortening in these patients.   "
121595|NCT01694329|"     The objective of this study is to document the residual burden of acute upper respiratory     infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and     auditory functional and anatomical abnormalities in children under the age of 5 years in     Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison     groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996)     and those exposed to PCV-7 exclusively (those born in 2003-2007).   "
121596|NCT01694316|"     The present study will explore the effectiveness of a computer based neurobehavioral     intervention in alleviating symptoms and improving emotion regulation in veteran's with PTSD.     It will increase understanding of psychopathology at a neural-circuit level and aid     development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin     Lab at Stanford University in California, but participants from the entire US are welcome to     participate as the study is delivered online.   "
121597|NCT01694303|"     The present study will explore the effectiveness of a computer based neurobehavioral     intervention in improving cognition and emotion regulation in a college freshmen population.     It will increase understanding of emotion-regulation and cognition at a neural-circuit level     and aid development of new interventions for emotion regulatory problems.   "
121598|NCT01694290|"     A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are     used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.      The ability of these to cool a person has never been quantified, the efficiency and extent of     cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of     this study is to determine whether strategically placed chemical ice packs will provide     benefit to individuals subjected to heat stress.   "
121599|NCT01694277|"     The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib     at 50 mg/day   "
121600|NCT01694264|"     Analysis of effect of anti-TNFα treatment on HBV reactivation among patients with systemic     rheumatic disease, especially rheumatoid arthritis   "
121601|NCT01694251|"     Even during mitral valve repair procedure (MVP) for severe mitral stenosis (MS), the     intraoperative assessment of mitral valve area (MVA) is necessary for evaluating the severity     of MS before the repair and excluding residual MS for immediate determination of the success     of the repair procedure and postoperative prognosis. For this purpose, several methods have     been applied by introperative transesophageal echocardiography (TEE): pressure half-time     (PHT) of mitral inflow Doppler and 2-dimensional (2D) planimetry methods have been widely     used in clinical practice. However, especially after MVP, the PHT method is usually     unreliable because it usually underestimates the MVA due to various intraoperative     hemodynamic factors.      The authors hypothesized that the MVA determined by 3D TEE would be more accurate than that     by PHT during immediate post-MVP procedure in severe MS patients and comparable to     postoperative MVA determined by MDCT. Therefore, the present study determined the MVA by     using PHT, 3D planimetry and MDCT before and after the MVP procedure in severe MS patients     and analyzed them to evaluate 3D TEE's utility for evaluation of MVA.   "
121602|NCT01694238|"     An investigation on the difference in stoma hernia frequency related to surgical technique     when incising the fascia. All patients planned for elective colostomy formation are to be     included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's     procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting     colostomy for any reason are all included.      The three groups for randomization are:      A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall     fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is     the parastomal hernia rate within 12 months from index surgery. Secondary end-points include     clinical variables, re-admission and/or re-operation due to any stoma complication, quality     of life and health economy analyses, at 12 months.   "
121603|NCT01694225|"     This study aims to establish the feasibility of using a monthly bubble package to improve     compliance rates among women prescribed adjuvant endocrine therapy.   "
121604|NCT01694212|"     Diabetes has many negative effects on patients' general health. Among many other consequences     it speeds up the cataract formation and that is why diabetic patients need cataract surgery     very often. The known side effect of cataract surgery even in otherwise healthy patients is     postoperative edema of the back of the eye (what causes decrease of vision), which has     greater incidence especially in patients who have diabetic eye problems. The cause of that     might be the intraocular inflammation which was previously demonstrated to be significantly     more prominent in patients with untreated diabetic eye problems. Therefore we will examine if     the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the     formation of the edema of the back of the eye.   "
121605|NCT01694199|"     Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of     pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.   "
125070|NCT01647542|"     The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific     adults with type 2 diabetes mellitus (T2DM).   "
121608|NCT01694160|"     The main objective of this study is to examine if paricalcitol may reduce progression of     graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus     have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are     related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated     for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an     anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol     is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials     with paricalcitol are performed in renal transplant patients examining the effect on     proteinuria and graft fibrosis.   "
121609|NCT01694147|"     To investigate the possible mechanisms of pulmonary and systemic permeability change     including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in     patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome     (ARDS).   "
121610|NCT01694134|"     The treatment of chronic low back pain is a major objective of public healthcare, because it     causes an important number of sick leaves. A correlation between clinical observations and an     inflammatory discopathy has been underlined, but there is currently any reference treatment.     In this study, the main objective is to assess the efficacy of an intradiscal injection of     corticoids versus local anaesthetic on the treatment of pain of patients with low back pain     associated to a Modic I discopathy.   "
121611|NCT01694121|"     The purpose of this study is to evaluate the effectiveness of the MEN Count intervention, an     HIV intervention and prevention program for heterosexual Black men. The MEN Count model     integrates HIV risk reduction and gender-equity counseling with housing and employment case     management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day     period. MEN Count was developed and pilot tested using a CBPR approach via funding from an     NIH R21, in Boston, MA. A more larger scale, two-armed quasi-experimental controlled trial     design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic     and other community-recruitment methods in Washington, DC. Study participants (N=504) will be     Black men reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex     partners in the past 6 months] and either current unemployment or homeless in the past 6     months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design     will be conducted in which participants will receive either MEN Count or an attention     comparison program similar to MEN Count in structure. We will assess program impact on     reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia,     gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12 month     follow-ups. Additionally, quality assurance and process evaluation efforts will be conducted     to ensure high quality program adherence and delivery, as well as to support program     replication should the model prove effective.   "
121612|NCT01694108|"     In high-income societies the use of health care and medication is steadily increasing.     Children have high morbidity, many visits at the general practitioner, an increasing number     of hospitalisations, and an increasing use of medication. And, when children are ill, someone     has to stay home to care for them. An un-explained global increase in the incidence of the     allergic diseases eczema, wheezing, asthma and allergies means that 25% of high-income     populations are affected. Cheap preventive measures are highly warranted. Recent studies have     shown a positive, non-specific effect of early Bacille Calmette Guérin (BCG) immunisation on     neonatal mortality in low-income countries and suggested a positive, non-specific effect on     allergic disease in high-income countries. Non-specific means that the vaccine effect goes     beyond prevention of the targeted disease, i.e. the BCG vaccine benefits the health status of     the immunised individual in ways unrelated to protection against tuberculosis (TB). For     instance, in a recent randomised trial in West Africa the investigators showed that the BCG     vaccine at birth was safe in low birth weight (LBW) infants and significantly reduced     neonatal mortality in these children, with a significant long-lasting effect on infant     mortality in the smallest newborns with a birth weight <1.5 kg. There is an urgent need to     explore the huge potential of the BCG's beneficial immune-stimulatory effects among children     in high-income populations.      Therefore, the investigators will carry out a large prospective randomised clinical trial in     Denmark primarily designed to test the hypothesis that infants who get the BCG vaccine at     birth experience 20% fewer hospitalisations during early childhood.      Secondary outcomes        1. To test the hypothesis that infants who get the BCG vaccine at birth are prescribed less          antibiotics during early childhood than non-BCG-immunised infants.        2. To test the hypothesis that Danish infants who get the BCG vaccine at birth develop less          eczema, asthmatic bronchitis/wheeze and food allergy at 3 and 12 months of age:          self-reported, diagnosed by a physician, or found at clinical examination; and are          prescribed less anti-eczema/asthma/allergy medication during early childhood than          non-BCG-immunised infants.        3. To test the hypothesis that infants who receive the BCG at birth respond in paraclinical          measures: Specific IgE, thymic gland size, leucocyte count and differentiation, monocyte          memory, cytokine profiles, and antibody titres following immunisation against          diphtheria, tetanus, pertussis, pneumococcus, hemophilus.        4. To test the hypothesis that infants who get the BCG vaccine at birth respond in growth          measures: weight, length and head circumference.        5. To test the hypothesis that infants who get the BCG vaccine at birth respond with          decreased morbidity: common cold, pneumonia, febrile episodes, diarrhoea and vomiting,          acute otitis media, febrile convulsions.        6. To test the hypothesis that premature infants with gestational age less than 37 weeks          who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages          and Stages scores.        7. To test the hypothesis that infants who get the BCG vaccine at birth has unaffected          coverage with the subsequent vaccinations in the Child Vaccination Programme.        8. To test the above mentioned hypotheses specifically in the strata of premature and          low-birth-weight Danish infants.   "
121613|NCT01694095|"     Age-related macular degeneration is one of the leading causes of blindness worldwide. The     factors that induce the progression of geographic atrophy, the advanced form of dry     age-related macular degeneration, remain poorly understood. The aims of this study are to     describe the natural history of geographic atrophy and identify potential risk factors     associated with a faster spread of atrophy that may be used to develop rational therapies.   "
121614|NCT01694082|"     Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally     utilized with Australian students, is unique in that it contains efficacious components     derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral     therapy (protective behavioral strategies), yet is very brief and has established efficacy.     This study aims to test versions of THRIVE tailored to American college students. In addition     to replicating original results with THRIVE, we will also test versions containing unique     subsets of protective behavioral strategies to reduce alcohol consumption. The primary     hypothesis is that versions of THRIVE will be associated with lower overall alcohol     consumption than an assessment and brief brochure control condition.   "
121615|NCT01694069|"     Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and     infection. A majority of people with cystic fibrosis have large quantities of bacteria     residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas     aeruginosa.      Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to     treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics     frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is     thought to be the most effective when there is a constant level of drug in the body. The     standard way to administer piperacillin-tazobactam is to give several grams 4 times each day     as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a     continuous infusion; a continuous infusion will make it more likely that drug will remain at     a constant level in the body. The objective of this study is to determine if administering     piperacillin-tazobactam as a continuous infusion is more effective at treating people having     a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a     day.   "
121616|NCT01694056|"     Soy protein has a high biological value, and contains several potential health-related     nutritional factors, i.e. its amino acids pattern, biological active peptides and non-protein     compounds such as isoflavones. In the field of obesity and blood lipids soy protein is     well-studied and appreciated; it improves circulating blood lipids and is associated with     weight reduction. The effect of soy on insulin resistance, glucose homeostasis and the     metabolic syndrome is less frequently studied. However, several molecular mechanisms of     action of soy protein make it a promising approach.   "
121617|NCT01694043|"     The purpose of the study is to investigate the effect of watching a television show with     healthy food commercials, unhealthy food commercials, or neutral commercials on the     consumption of healthy snack foods or unhealthy snack foods. There are three hypotheses: 1)     Women exposed to a television show with commercials imbedded advertising food will consume     more food than women exposed to a television show with non-food related commercials.      2) Women will consume more food when exposed to a television show with commercials     advertising unhealthy food as compared to a television show with commercials advertising     healthy food.      3) Women will consume the most food when exposed to a television show with unhealthy food     commercials and have unhealthy snack foods available to consume.   "
121618|NCT01694030|"     The purpose of this study is to explore whether asking participants to visualise a secure     attachment figure or a neutral event leads to differences in self-reported felt security or     depressed mood. Furthermore, the investigators aim to explore whether it is possible to keep     a secure prime activated over 3 days via text message visualisation tasks.   "
121619|NCT01694017|"     The purpose of this study is to compare clinical, economical and quality of life (QOL)     outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen.     This study will be an unblinded randomized trial. The first step will be empirical data     collection for one year for calculating the incremental cost effectiveness ratio (ICER). The     second step will be to perform a simulation model for calculating long term ICER.   "
121620|NCT01694004|"     Preliminary studies in humans suggest that the presence of lipids in the gut can modify     glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid     sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid)     absorption from the GI tract through a gut-brain-gut axis.   "
121621|NCT01693991|"     Research questions: Pilot study research questions: Primary: 1)Can we recruit a sufficient     number (i.e., at least 60 patients over 9 months) and retain a sufficient proportion of both     men and women (i.e., at least 80% at 2, 4, or 6 months post-randomization) with advanced     cancer in all 3 trial arms to allow completion of a full study in 4 years?; 2)Is MMi     acceptable: to a general ACP? to both men and women?; Secondary: 1)Is it feasible to complete     the intervention in 3-4 weeks? 2)How long is it feasible to test MMi effects: 2, 4 or 6     months post-randomization(retention rate=80%)? 3)Which recruitment strategies are most     helpful? 4)What sample size is needed for a full study? Full-study research questions:     Primary: Does adding the MMi to usual care (experimental group or EG) enhance meaning in life     among newly diagnosed ACP, compared with those receiving usual care plus meetings with an     empathic non-professional visitor (i.e., attention-control group or AC) or usual care alone     (UC), at x months post-randomization? (time determined in pilot) Meaning in life (primary     outcome) is defined as the belief that one's life has significance and purpose (i.e., global     meaning) and newly diagnosed ACP is defined as the 6 months after first occurrence of,     progression toward, or recurrence of stage III or IV cancer (TNM classification system).     Secondary: In our future full-study, we plan to evaluate MMi effects on secondary outcomes     such as existential wellbeing (MQOL existential wellbeing) and posttraumatic growth     (Post-Traumatic Growth Inventory). We also plan to test a theoretical model where sense of     meaning in life has a protective (moderating) effect on tertiary outcomes such as physical     QoL (MQOL physical subscale), anxiety and depression (Hospital Anxiety and Depression Scale     (HADS)), and overall QoL (MQOL Total) in EG patients. Methodology: RCT pilot study with 60     newly diagnosed ACP (stages III or IV) within 2 months of referral and 6 months of     randomization, assigned randomly to: (1) EG, (2) AC, or (3) UC. Patients will complete     self-report questionnaires (including outcome measures, as well as sociodemographic and     medical variables) at 2, 4 and 6 months post-randomization.   "
121622|NCT01693978|"     The aim of this research is to assess whether Contingency Management is effective in     improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD.     Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few     studies of this treatment in substance users have shown poor adherence. Contingency     Management is a well-established approach that could be used to enhance adherence to PE. From     a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction     Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD     will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged     Exposure with Contingency Management (PE+CM) condition that provides monetary-based     incentives for attending the PE therapy sessions. The comparison condition will be assigned     to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE     sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will     be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and     rates of drug use (urine specimens, self-reported use). The study's three primary aims are to     1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to     increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy     of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD     patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.   "
121623|NCT01693965|"     Bronchopulmonary infection is the most common and serious complication in the evolutionary     course of cystic fibrosis (CF). Administration of antibiotics adapted to infecting pathogens     is one of the key issues for its management. However, more than half of patients with CF have     chronic respiratory infections for which infectious agent remains unknown leading to     empirical antibiotic therapies that are not adapted to the causative agents. Recently, new     technologies have been applied for the description and characterization of microbial agents     in CF patients including molecular biology techniques that allowed us to detect and to     identify new and/or emerging pathogens. Moreover, more sophisticated molecular techniques     such as pyrosequencing and PCR amplification and cloning lead us to demonstrate the huge     microbial diversity associated with chronic bronchopulmonary infections in this population.     Otherwise, a metagenomic approach revealed the extraordinary complexity of the respiratory     flora in these patients and, somewhat unexpected, abundance of anaerobes, viruses, and     bacteriophages. In addition, it has been shown that some antibiotics commonly used in     clinical practice for the treatment of respiratory infections were able to induce these     bacteriophages, suggesting the existence of lateral gene transfer by transduction. The human     microbiome is the set of microbial communities associated with the human body and represents     all living microorganisms in the body. Its role in the immunity development has recently been     demonstrated suggesting that changes in this ecosystem play a critical role in evolution of     several human diseases. For example, in obesity it has been shown that there is a     relationship between the intestinal human microbiota and nutritional and metabolic status of     the hosts and specific alterations of these intestinal microbiota may represent a metagenomic     signature of this disease. Evolution of the respiratory microbiota in patients with cystic     fibrosis, whose nutritional status is often impaired (chronic malnutrition due to disorder of     digestive absorption) and receiving regular antibiotic treatments remains unknown to date.     Characterization of this ecosystem and its role is a critical step to understand the     evolutionary course of the disease.      The main objective of this seminal study is to describe and to characterize the respiratory     microbiota from sputum samples obtained from a limited number of selected patients with CF     from 5 regional care centers (CRCM) from South of France (Mucomed network) (2 patients per     center : 6 adults and 4 children), with similar clinical, microbiological and functional     status before and after a cure of antibiotics. Different microbiological tools will be used     including axenic culture systems, co-culture on amoebae in order to to isolate and to     identify the microbial communities. Identification of bacteria will be done using MALDI-TOF     mass spectrometry and/or molecular techniques. Moreover, 16S rRNA PCR amplification followed     by cloning and sequencing of PCR products from the same sputum sample will be carried out to     identify and to compare the bacterial species identified using molecular methods. In a second     step, once the respiratory microbiota was characterized, it will be interesting to develop a     dedicated microarray that will allow to detect all the bacteria identified in the first stage     of the project and to assess its relevance on a larger cohort of patients with CF by studying     the correlation between the respiratory microbiota and clinical status of patients according     to the prescribed antibiotic treatments.      This study will open new clinical perspectives and will help us to determine the potential     role of antibiotics on the microbiota evolution during treatment according to regional health     care practices. This will contribute to better understand the role of the microbiota in the     evolution of these chronic respiratory infections. It could be the first step for innovative     therapeutic strategies, taking into account the balance of complex microbial flora and     possibly evolving according to antibiotic therapies. It could also form part of a larger     preventive strategy against transmission of specific pathogens in CF.   "
121624|NCT01693952|"     Treatment of cancer, and more particularly of haematological malignancies, partly relies on     chemotherapy. Most therapeutic regimens display various toxicities, one of the most common     being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia     can be overcome by haematological growth factors and transfusion, one of the most severe     life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite     the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major     limitation in chemotherapy which is responsible for the majority of treatment-related     morbidity and mortality and for prolonged hospitalisation.      In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic     patients. While the occurence of neutropenia and sepsis is often unpredictable and thus     difficult to study in a prospective way, stem cell transplantation represents a quite     convenient model to study such a question. Autologous stem cell transplantation indications     in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease. Briefly,     after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by     cytapheresis and frozen. When the patient has reached complete remission by conventional     chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called     conditioning regimen). The conditioning regimen targeted to have high antitumoral     activity leads to a cytokine storm resulting in a programmed inflammation. 36 hours after     the lasting of the conditioning regimen, the CD34+ cells are thawed and infused to the     patient. Thus neutropenia usually begins at D4 post transplantation and lasts for 10 days,     until graft becomes functional. Thus, the timing and duration of neutropenia are very     homogeneous. During neutropenia, fever and sepsis are very frequent (>80% patients), thus,     most patient will be informative regarding sepsis, and there is an easy possibility of     biological sampling before programmed inflammation (due to conditioning regimen), after     inflammation before sepsis, then during and after the sepsis. Since the patient is     hospitalized, the kinetic monitoring is quite easy   "
121625|NCT01693939|"     The purpose of this study is to document the programmed flap thickness to achieved flap     thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200     Femtosecond laser is a precision surgical device that is used to create a flap in a FDA     approved LASIK procedure.   "
121626|NCT01693926|"     The objective of the study is to evaluate the impact of physical activity in obese and     nonobese prepubertal children on:        1. biological stress responses during a psychosocial stress test        2. snacking and feeling of hunger in response to the same psychosocial stress test        3. the moderating factor of attachment on the biological stress responses and on snacking      Children will be investigated on one study day during 3.5 hours.   "
121627|NCT01693913|"     That a treatment using a cognitive-behavioral treatment for exercise and nutrition support     will be associated with greater weight loss that a treatment of nutrition and exercise     education.   "
121669|NCT01693367|"     The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used     to stabilize the shaft component of distal femur fractures in comparison to standard locking     screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC     score) due to increased and more symmetrical callus formation and fewer non-unions.   "
121628|NCT01693900|"     Surgical trauma causes nerve sensitization leading to amplification and prolongation of     postoperative pain. In experimental studies, pre-injury neural blockade using local     anesthetics has been shown to reduce post-injury sensitization of the central nervous system,     while similar techniques applied after the injury had less or no effect (FILOS).     Investigators have therefore designed this study to examine the timing of FICB     (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing     anterior hip replacement surgery.   "
121629|NCT01693887|"     The purpose of this study is to Comparison clinical efficiency with IPFI patients who treated     by different protocols(empirical therapy or preemptive therapy) in ICU.   "
121630|NCT01693874|"     The investigators are developing and then testing whether Mindfulness-Based Stress Reduction,     a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms     and improves cognitive functioning in older adults.   "
121631|NCT01693861|"     Observational, non randomized study aimed at measuring the effect of chemotherapy in the     urinary concentrations of physiological modified nucleosides in 30 patients with metastatic     colorectal cancer.   "
121632|NCT01693848|"     Observational, non randomized study aimed at measuring the effect of surgical resection of     metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients     with metastatic colorectal cancer.   "
121633|NCT01693835|"     Observational, non randomized study aimed at measuring the circadian rhythms in the urinary     concentrations of physiological modified nucleosides in 30 patients with metastatic     colorectal cancer and in 30 age and sex-matched healthy subjects.   "
121634|NCT01693822|"     A-PREDICT is a study of axitinib in patients with metastatic renal cell carcinoma unsuitable     for nephrectomy (as judged by the treating clinician) to evaluate efficacy, safety, toxicity     and changes in biomarkers during therapy. Axitinib will given twice daily by mouth according     to tolerability of treatment, for as long as patients are deriving clinical benefit. Blood     and tumour tissue samples will be taken prior to and during therapy to evaluate biomarkers of     treatment response. The primary clinical objective of this study is to define the activity of     axitinib given to patients with metastatic renal cell carcinoma unsuitable for nephrectomy.   "
121635|NCT01693809|"     The principal aim of this study is to evaluate the presence of changes in cervical vestibular     evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.      Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service     of the hospital.   "
121636|NCT01693796|"     The purpose of this study is to determine the average risk for thyroid irradiation for any     type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv,     adjusted to the measured thyroid volume and to the patient's age.   "
121637|NCT01693783|"     This phase II trial studies how well ipilimumab works in treating patients with human     papilloma virus (HPV)-related cervical cancer that has come back or that has spread to other     areas of the body. Monoclonal antibodies, such as ipilimumab, can find tumor cells and help     kill them or carry tumor-killing substances to them.   "
121638|NCT01693770|"     Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for     pain control through thermally-induced cell death and periosteal denervation caused by     cortical heating relative to acoustic energy absorption. There is also evidence that a high     intensity focused ultrasound beam can penetrate through the cortical bone to the medullary     space, producing thermal necrosis of cancer tissue. However, little is known about the     potential effects of MRgFUS as first line therapeutic modality for pain palliation in     skeletal metastases.      Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of     painful bone metastases and determine the potential of this technique for local tumor     control.   "
121639|NCT01693757|"     The purpose of this study is to compare hop performance and jump landing strategy in soccer     players with higher level sports activities after ACLR using either BPTB or STG and controls.   "
121640|NCT01693744|"     Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material     in an eye structures and many other parts of the body including kidneys and blood vessels. As     both PEX and chronic kidney disease (CKD) are associated with oxidative stress and     endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.      Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic     kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60     mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients,     group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal     kidney functions (control group). Demographic properties and the rate of PEX were evaluated     and compaired between the groups.   "
121641|NCT01693731|"     The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex,     Aromasin or Femara affect a woman's oral health and oral health related quality of life.     Patients, dental professionals and medical oncologists will benefit from a greater     understanding of the best oral care follow up practices of breast cancer survivors using     aromatase inhibitors.   "
121642|NCT01693718|"     The goal of the study is to test a particular combination of drugs and determine their     ability to completely eliminate head and neck cancer.   "
121643|NCT01693705|"     To determine the morbidity and mortality of patients who have undergone percutaneous     tracheostomy due to respiratory failure in the critical care unit and after intensive care in     the internal medicine department, including follow-up of quality of life of these patients.   "
121644|NCT01693692|"     The purpose of this study study is to determine whether TD-9855 is effective in treating     patients with fibromyalgia.   "
121645|NCT01693679|"     • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver     cirrhosis.   "
121670|NCT01693354|"     The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective     in the reduction of the crude mortality risk in patients who have been undergoing renal     replacement treatment for less than 1 year. Patients will be randomized since the beginning     of the study in two groups: standard HF dialysis and mid-dilution HDF.   "
121671|NCT01693341|"     To examine the feasibility of improving stroke patients' physical functional recovery and     social participation through improving caregiver's care capability.   "
121646|NCT01693666|"     Gaining too much weight in pregnancy is associated with adverse pregnancy complications and     can have a long-term impact on maternal and offspring health, including increased risk for     obesity and metabolic disease. Preventing excessive gestational weight gain could reduce     adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty     obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned     to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will     be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery.     Women in the LIFE program will be given guidance on healthy eating and exercise at their     regularly scheduled obstetric visits. To increase adherence to the program, a contingency     management (CM) intervention offering incentives will be used to establish and maintain     healthy nutrition and physical activity habits, working towards the goal of restricted weight     gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all     participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary     outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum,     and objective measures of maternal and offspring health.   "
121647|NCT01693653|"     This is a double-blind placebo controlled study targeting individuals with active Behcet's     Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to     conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable     dose for 4 weeks before enrollment. Prednisone or equivalent (< 10mg/day) permitted if dose     stable for 6 weeks prior to enrollment.      The study will investigate the safety of tocilizumab for this vasculitic condition in     addition to its efficacy.      The planned sample size is 30 participants per arm for a total of 60 participants. The study     would be for 3 months, with a safety follow up at 2 months after study termination.      Study participants will stay on their current treatments and either tocilizumab or placebo     infusions will be given every 4 weeks in addition. Patients will be randomized to Actemra IV     8mg/kg Q 4 weeks X 3 doses or placebo.   "
121648|NCT01693640|"     Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's     patients   "
121649|NCT01693627|"     A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:        1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented          femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy,          Warsaw, Indiana) and        2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral          stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw,          Indiana)      There will be a further in-group randomisation to a Corail femoral stem with or without a     collar, creating a number of 4 study-groups in total.      The aims of the study are:        -  To compare polyethylene wear and migration of the moderately cross-linked Marathon          polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)        -  To evaluate micromigration and periacetabular bone mineral density of the 2 cups using          radiostereometry(RSA)        -  To evaluate the migration patterns and proximal femoral bone density changes around the          Corail stems with and without a collar   "
121650|NCT01693614|"     This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in     patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell     lymphoma (MCL) or follicular lymphoma (FL).   "
121651|NCT01693601|"     This is a single-center, single arm, dose finding study to assess safety and tolerability of     the oral combination of Panobinostat and Ruxolitinib in patients with myelofibrosis (MF) in     chronic and accelerated phase.   "
121652|NCT01693588|"     High levels of postoperative pain are associated with an increased risk of lung and heart     complications, are the most common reason for delayed discharge or for unexpected hospital     admission after ambulatory surgery, and are responsible for prolonged recovery after     inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight     gain and may have an impact on the patient's nutrition post operatively. The purpose of this     study is to evaluate the effectiveness of a multimodality pain management protocol on     postoperative neurosurgical pain.   "
121653|NCT01693575|"     The purpose of the study is to gather clinical data and safety information on the use of APX     100 device for small-pupil cataract surgery and the management of intraoperative floppy iris     syndrome (IFIS) during cataract surgery.      The APX 100, a FDA-approved device (510K exempt), is a disposable stainless steal sterile     device for mechanical expansion of pupillary diameter during intraocular surgery. The APX 100     is inserted to the anterior chamber of the eye through standard clear corneal incisions. The     device is then located on the pupil's border between the iris and the anterior lens capsule     and the pupil's diameter is expanded.      The APX 100 will be used in standard phacoemulsification cataract extraction surgery when     small pupil diameter (<4.5 mm) is recognized preoperatively or develops intraoperatively due     to IFIS.   "
121654|NCT01693562|"     This is a multicenter, open-label, first-time-in-human study with a standard 3+3     dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase     in patients with advanced solid tumors. An exploration cohort has been added to determine the     safety using Q4W dosing.   "
121655|NCT01693549|"     The purpose of this study is to determine whether cabazitaxel is effective in the treatment     of metastatic breast cancer.   "
121656|NCT01693536|"     A randomised controlled trial to test if offering three visits to a dietician + two visits to     a physiotherapist over six months + a home sphygmomanometer, will result in a reduction in     sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled from     Oct 2008 to July 2009.   "
121657|NCT01693523|"     The goal of this research study is to learn if pancreatic cancer and the FOLFIRINOX     chemotherapy are associated with symptoms such as fatigue, pain, disturbed sleep, lack of     appetite, and drowsiness, among others. Researchers also want to learn whether any symptoms     you may have are related to markers of inflammation. Markers of inflammation are found in the     blood and may be related to symptoms you may have.   "
121672|NCT01693328|"     National multicenter, prospective, observational study in cancer patients with chronic     background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic     condition by a specialist in the treatment of cancer pain conditions.      • Study objectives include assessment of early treatment satisfaction.   "
121658|NCT01693510|"     Weight gained during pregnancy is referred to as gestational weight gain (GWG). Excess GWG is     a widespread problem that occurs in 55-75% of Canadian women who enter pregnancy overweight     or obese (a group that represents over 50 % of all pregnant women) and about 40% women of     normal weight. Excess GWG is associated with complications of pregnancy, such as post-partum     weight retention, type 2 diabetes, elevated fats in the blood, and high blood pressure and     may also lead to problems with the health of the newborn child. Our research aims to find     ways to control GWG by developing new and practical approaches to diet and exercise targeted     to overweight pregnant women that hold promise of improving their health both during     pregnancy and thereafter. The experimental intervention is a diet of higher protein provided     by dairy foods combined with an exercise program modified to the abilities of overweight     pregnant women; and the control is the usual advice given by their primary care providers,     information on healthy pregnancy from Health Canada, and a focus group session exploring     women's experiences with exercise, nutrition, and gestational weight gain. The results of     this study will allow us to design future large clinical studies in all pregnant women to     help control the weight gain in all pregnant women.   "
121659|NCT01693497|"     This study aims to compare two active psychological treatments for PTSD. One is an     established therapy, Cognitive Processing Therapy (CPT) which operates as a control condition     for a newly developed intervention, an integrative Gestalt-based trauma therapy, Dialogical     Exposure Therapy (DET). There is no inactive control condition. We expect the two therapies     to perform on a similar level, which would constitute evidence for the efficacy of DET.   "
121660|NCT01693484|"     Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to     learn if patterns of blood-flow around the incision site of patients undergoing surgery for     heel-bone fractures can help predict whether complications will arise after a specific type     of operation.The goals of this research study are to effectively answer as many of the     following research questions as possible:        1. Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue          transfer be used to identify altered patterns of blood flow at the operative site of          Calcaneus fractures, when compared to the uninjured extremity?        2. Are changes in blood flow identifiable at the operative site post operatively?        3. Are there certain patterns of blood flow present preoperatively or postoperatively that          can predict wound complication?        4. Can certain patterns of blood flow predict the location of slough or dehiscence after          surgery?        5. Does the incision site and its proximity to specific patterns of blood flow possibly          predict wound complication?      The hypothesis is that the study drug will show a correlation between certain patterns of     blood flow and whatever post-operative complications may arise.   "
121661|NCT01693471|"     The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting     from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients     whose control levels are partly controlled or uncontrolled.   "
121662|NCT01693458|"     The Appreciative Inquiry Change Agents (CA) program (NAMWEZA) intends to address broad     societal issues by engaging HIV-positive leaders as 'change agents' in their communities. In     this study, the CAs will be recruited from an HIV Care and Treatment Centre in Dar es Salaam.     The Namweza program has the potential to address structural issues related to HIV risk, such     as access to limited resources, through an entrepreneurial component of the program. A     positive, or appreciative, focus promotes CAs to examine assets in themselves and in their     networks, encourages strengthening of relationships, and facilitates planning for a positive     future for themselves, their families, and their communities.      A stepped wedge randomized trial will be performed to evaluate the effectiveness of the     program for the following primary outcomes: uptake of HIV services among network members of     the CAs; rate of unprotected sex and frequency of concurrent relationships among CAs and     their social networks; and levels of self-esteem, general self efficacy, and risk of intimate     partner violence in the CAs. Secondary outcomes include: depressive symptoms, hopefulness,     and HIV-related stigma (among CAs); social support and quality of relationships (among CAs);     and HIV knowledge, attitudes and self-efficacy in preventing HIV transmission or re-infection     (CAs and their networks).      The following are primary hypotheses that will be tested through this stepped wedge     randomized trial evaluation:        1. Uptake of HIV services will increase among individuals in the network of the          HIV-positive Change Agents related to the intervention;        2. Levels of self-esteem and general self-efficacy will increase in trained Change Agents;        3. Rate of unprotected sex and number of concurrent partners will decrease (among network          of Change Agents as well as Change Agents themselves; i.e. the 'study population'); and        4. Prevalence of intimate partner violence (IPV) will decrease in Change Agents.           Secondary hypotheses are:        5. Prevalence of depressive symptoms and HIV-related stigma will decrease and level of          hopefulness will increase in trained Change Agents;        6. Levels of HIV knowledge, attitudes and self-efficacy in preventing HIV transmission and          re-infection among CA and their networks will increase; and        7. Degree of social support and quality of relationships will improve among CA.      If the proposed intervention is found to be effective, linkages with the Tanzanian Ministry     of Health and other stakeholders will enable scale-up of the program throughout the country.   "
121663|NCT01693445|"     This study will attempt to determine the feasibility of combination of Oxaliplatin,     Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used,     and to preliminarily evaluate the antitumor activity in untreated patients with advanced     gastrointestinal cancer.   "
121664|NCT01693432|"     This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean     patients with esophageal cancer.   "
121665|NCT01693419|"     This study will conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line     chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression,     KRAS mutation, and BRAF mutation as predictive or prognostic markers   "
121666|NCT01693406|"     Childhood obesity is a critical global public health concern. Breastfeeding is the ideal     choice for infant nutrition. However, rapid and excess weight gain during infancy predicts     later, even among breastfed infants. This risk is higher if mothers are obese and/or     diabetic. Composition of bioactive components of breast milk may differ based between mothers     who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are     associated with overall increases in inflammation and oxidative stress, but how breast milk     composition is affected remains unknown. Our overarching goal is to determine how maternal     obesity and Type 2 Diabetes impacts human breast milk composition and how differences in     composition may impact infant growth and fat development. We are undertaking a study that     follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and 20 Type 2 Diabetic mothers     and their infants over the first 4 months of life. We will track infant weight and fat gain     and monitor maternal glucose control. We will also collect breast milk samples over the first     4 months and measure concentrations of growth and appetite hormones, cytokines, markers of     oxidative stress and nutrient composition in milk. We predict that concentrations of     growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and     markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast     milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers'     breast milk. We expect these differences will be most pronounced in the first 2 weeks after     birth. We also predict that breast milk concentrations of these biomarkers will be associated     with infant fat gain. What we find will help us understand how early infant nutrition and     growth may affect that child's later risk of obesity.   "
121667|NCT01693393|"     Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary     Sjögren Syndrome   "
121668|NCT01693380|"     Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated     household members.   "
121673|NCT01693315|"     The objective of this dose-escalation study is to evaluate the safety, tolerability and     efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension     or primary open-angle glaucoma.   "
121674|NCT01693302|"     Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to     the delayed action of insulin when compared to carbohydrate absorption from food. It is the     hypothesis of the investigator that administering the insulin for a meal 20 minutes before     the meal will result in lower blood glucose peaks compared to administration of insulin     immediately before or 20 minutes after starting to eat.      All subjects will eat the same meal on three different occasions. Insulin will be     administered at one of the three times at each visit.   "
121675|NCT01693289|"     the study compare the hormonal-metabolic and reproductive outcome between combined     metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic     syndrome   "
121676|NCT01693276|"     This study will analyze the effects, good and/or bad, of the drug Abraxane in combination     with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally     advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in     this study are FDA-approved for use in patients with pancreatic cancer.   "
121677|NCT01693263|"     Dialysis access, which is the connection that allows blood to flow in and out of the body     during dialysis sessions, is important to remove wastes and excess fluid for patients with     end stage renal disease (ESRD). One method used to access the vein and artery for dialysis is     called a brachiocephalic fistula. Patients are being asked to participate in this study     because they have endstage renal disease, and their doctor has recommended that they will     have brachiocephalic fistula placed for their dialysis access.      A common problem seen in patients with a brachiocephalic fistula (BCF) is cephalic arch     stenosis (CAS). CAS is a narrowing in the central vein (located in the upper chest). CAS     causes problems with the opening of the veins and arteries needed for dialysis. Once someone     suffers CAS they may need several radiology procedures as well as surgery to help correct the     problem.      The BCF may fail once CAS develops.      The purpose of the research study is to gather information about the BCF and what is     happening inside the vein. The researchers hope to find out what may be the cause of CAS.   "
121678|NCT01693250|"     The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the     increased prevalence of childhood obesity in the last two decades. Obesity during the     adolescent years is associated with many adverse health consequences, including T2DM,     hyperlipidemia, and psychosocial problems. The first step toward effective obesity management     and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the     rapid expansion of cellular networks, and advancements in smartphone technologies, it is now     possible to monitor PA and dietary intake and at the same time to transmit data digitally to     their primary care providers (PCP). The proposed pilot study will include the collaboration     among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese     adolescents. The study will adapt and implement smartphone-based technologies and integrate     these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake.     Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the     smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the     effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid     profile), at 3 months post intervention between the intervention and control groups. The     smartphone app for the intervention group will allow the teens to graphically compare daily     PA and dietary intake with the goal, participate in a reward program where they can collect     virtual points for achieving the goal, and play interactive games related to PA and diet. A     total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to     the feasibility study (Aim 2). Findings from this study will be used to plan for a NIH R01.   "
121679|NCT01693237|"     The current trial aims to investigate the impact of continuous feedback on dropout and     outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist     on treatment progress and alliance will 1) increase adherence and 2) increase treatment     outcome.   "
121680|NCT01693224|"     The purpose of this study is to evaluate the accuracy, diagnostic yield, operational     performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting     tuberculosis in HIV-infected adults.      A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid     Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.   "
121681|NCT01693211|"     This is a prospective, randomized study evaluating the circularity of the anterior     capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual     capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with     cataract, scheduled to undergo removal by phacoemulsification with intraocular lens     implantation in SNEC.      The primary study end point is to determine if the circularity of the created rhexis is     better in Group A as compared to Group B.      The secondary study end point is to determine the diameter of rhexis is more precise and     reproducible in Group A as compared to Group B.   "
121682|NCT01693198|"     People swimming or surfing in lake Kineret , sometimes complain of nasal stuffiness ,     sneezing and itching .Typically, it happens during or immediately after contact with the     lake`s water . The symptoms are compatible with immediate allergic reaction. Previous reports     suggested a connection between similar symptoms and contact with different cyanobacteria     (living in fresh water lakes). In this study we intend to prove the mechanism of these     reactions. To prove the exact allergen that causes allergic rhinitis allergists perform skin     tests with different suspected allergens. Likewise, we would like to perform skin tests to     different proteins extracted from cyanobacteria collected in lake Kineret.   "
121683|NCT01693185|"     The aim of the present study is to compare patient's recovery times after elective     colonoscopy employing remifentanil only vs conventional combination of midazolam and     meperidine   "
121684|NCT01693172|"     The aim of this study is to evaluate the effect of an early postoperative physical     rehabilitation program on the functional capacity and incidence of postoperative     complications in patients undergoing major elective surgery for treatment of a neoplasm   "
121685|NCT01693159|"     The SUPPORT trial is an open-label, prospective, randomized, national multicenter     intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard     treatment of each institution on the pain intensity and QoL in patients with locally advanced     head and neck cancer suffering from painful cetuximab-induced rhagades during     radioimmunotherapy.   "
121688|NCT01693120|"     VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded,     investigational clinical study. The purpose of this clinical study is to evaluate the risk of     procedure and/or device related strokes in subjects with persistent or long-standing     persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.   "
121689|NCT01693107|"     This study will be divided into two phases. The purpose of the Phase I registry is to assess     the current force being used for ablation of symptomatic paroxysmal AF in a wide range of     operators in different Canadian centres with the operators being blinded to the contact force     data.      In Phase II of the study, operators will have open use of the force contact data. Phase I and     II data will be compared in order to assess the efficiency of using the THERMOCOOL®     SMARTTOUCH™ catheter.   "
121690|NCT01693094|"     The investigators plan a prospective randomized controlled study that compares the treatment     decisions made by patients who receive decision aids, as compared to patients treated with     usual care and the American Society for Surgery of the Hand brochures. The investigators     expect to enroll 126 patients.   "
121691|NCT01693081|"     'Off periods' where people with Parkinson's disease are slow, stiff and unable to function     are disabling, and a treatment which can converts people to a on, good, able to function     state would be extremely useful. We assessed safety, tolerability and efficacy of inhaled dry     powder apomorphine (VR040) in a clinic-based study in this setting.   "
121692|NCT01693068|"     This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus     dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with     N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the     progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and     by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their     relationship with pimasertib exposure.   "
121693|NCT01693055|"     Study title        -  Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design        -  single arm and Investigator Initiative pilot study   "
121694|NCT01693042|"     Single or repeated application of autologous bone marrow-derived stem cells to treat chronic     post-infarction heart failure   "
121695|NCT01693029|"     The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed     reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to     generate data supporting that the efficacy and safety under treatment with HX575 and     Epogen®/Procrit® are comparable.   "
121696|NCT01693016|"     The purpose of this study is to evaluate the value of the new technique of non-invasive     measurement of Hb in children undergoing a surgical procedure.   "
121697|NCT01693003|"     Exercise intolerance is a major complain of patients with chronic obstructive pulmonary     disease (COPD). Dynamic hyperinflation has been recognized as an important limiting factor     responsible for the appearance of intolerable dyspnea during exercise. Regular treatment with     long-acting bronchodilators promotes a more sustained reduction of hyperinflation and     consequent symptom relief and increase in the patient's ability to overcome physical demands     of daily life. Tiotropium bromide (TIO) is a new generation, long-acting anticholinergic     bronchodilator that significantly improves lung function, reduces symptoms and improves     exercise tolerance in patients with advanced COPD. Indacaterol is a new ultra-long duration     (>24 h) β2-agonist, which promotes sustained dilation of the bronchi with a once-daily     administration. Compared to tiotropium, indacaterol provides evidence that is as effective as     tiotropium for bronchodilation, as well as other clinical outcomes such as dyspnea and state     of health. However, comparative effects of indacaterol versus tiotropium with regard to     outcomes in tolerance, dyspnea and dynamic lung hyperinflation during exercise is scarce. We     hypothesized that indacaterol and TIO are not different in terms of exercise tolerance and     its determinants (dynamic hyperinflation and dyspnea).   "
121698|NCT01692990|"     20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of     0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they     were given a standard breakfast and asked to report their appetite on visual analogue scales     (VAS) immediately before and after the meal. The results were analyzed in accordance with the     paired design under consideration of both supplement sequence and gender.   "
121699|NCT01692977|"     The disruption of spatial orientation is considered the second most common cognitive symptom     of dementia, affecting nearly all activities of daily living. Research in the field of     environmental psychology has helped to highlight the influence of the environment on patients     with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has     been shown that an environment can provide support for cognitive failures in subjects if that     particular space is adapted. While numerous studies have focused on the architectural     environment (hospital, housing facility), none have explored the ability of patients to     orient themselves in a natural environment such as a garden. Yet, in recent years, such     gardens, known as healing gardens, have emerged in housing and care facilities, providing     genuine support for the care management of patients with Alzheimer-type dementia. Various     works have been published outlining recommendations for their management. However, with     regard to spatial orientation, none of the available research has explored the basic     principles on which to rely on in order to organize the elements of outdoor spaces into     itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of     such data, these authors recommend relying on five elements, identified by Lynch in his     landmark book Image of the City (1960), that people use to orient themselves and find their     way. These are  paths ,  edges ,  districts ,  nodes  and  landmarks . The     hypothesis to verify is that patients with Alzheimer's disease do not rely on the same     elements of the garden as non-Alzheimer's subjects in making orientation decisions and to     mentally picture this environment.   "
121700|NCT01691924|"     No clinical trials with PBF-509 in humans have been performed to date. Only preclinical     studies have been done to assess the pharmacology and pharmacokinetics, the safety and the     toxicological profile of the PBF-509.      An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical     trial where a single oral, dose-escalating, and placebo-controlled design will be     implemented.   "
125093|NCT01648283|"     This research study will determine if genetic variation in CYP2B6 affects how the body     metabolizes methadone.   "
121701|NCT01691911|"     Major vascular surgery involves operations to repair swollen blood vessels, clear debris from     blocked arteries or bypass blocked blood vessels. Patients with these problems are a     high-risk surgical group as they have generalized blood vessel disease. These puts them at     risk of major complications around the time of surgery such as heart attacks , strokes and     death. The mortality following repair of a swollen main artery in the abdomen is about 1 in     20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple     and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote     ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to     muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a     further five minutes. This cycle is repeated three more times. The blood supply is     interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated     brief interruption of the muscular blood supply sends signals to critical organs such as the     brain and heart, which are rendered temporarily resistant to damage from reduced blood     supply. Several small randomized clinical trials in patients undergoing different types of     major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial     aims to determine whether RIPC can reduce complications in routine practice.   "
121702|NCT01691898|"     This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab     vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX),     as well as a combination of polatuzumab vedotin with obinutuzumab in participants with     relapsed or refractory follicular non-Hodgkin's lymphoma (NHL) and relapsed/refractory     diffuse large B-cell lymphoma (DLBCL).   "
121703|NCT01691885|"     The primary objective of the study is to test the hypothesis that lung hyperinflation     contributes to cardiac dysfunction in COPD and that the treatment of lung deflation with     FF/VI Inhalation Powder 100/25 mcg administered once daily (QD) will result in the reversal     of this cardiac dysfunction compared with placebo. This will be assessed by measures of right     and left global and regional systolic and diastolic cardiac function as assessed using a 30     minute CMR.      A secondary objective will be to investigate the effect of FF/VI inhalation powder 100/25mcg     QD on measures of arterial stiffness in the form of pulse wave analysis and distensability in     the pulmonary and systemic circulation.   "
121704|NCT01691872|"     This is an open-label, single centre, parallel group study to evaluate the safety and     pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese     subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also     incorporated. This study is intended to facilitate inclusion of Japanese patients in the     global phase III program for retigabine XR formulation.   "
121705|NCT01691859|"     This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab     administered subcutaneously (SC) in addition to standard of care in subjects who participated     in the MEA112997 study. At each clinic visit, adverse events will be assessed and     exacerbations will also be reviewed.   "
121706|NCT01691846|"     This multicenter, randomized, double-blind, placebo-controlled study will assess the     efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared     with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately     controlled with metformin monotherapy. Patients will be randomized to receive oral doses of     150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26     weeks.   "
121707|NCT01691833|"     The purpose of the study is to determine whether vitamin D supplementation in patients with     hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with     fractures of the humerus, femur, or tibia. The central hypothesis of the study is that     vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the     risk of nonunion compared to placebo treatment.   "
121708|NCT01691820|"     The purpose of this study is to estimate the incidence of CMV secondary infections     (re-infections/re-activations) and the incidence of CMV primary infections in adolescent     females.   "
121709|NCT01692951|"     This study aims to evaluate the performance of serum free fatty acids as biomarkers for the     identification of lung cancer.   "
121710|NCT01692938|"     To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO.     The study will assess variability across measurements taken by three different     operator-device configuration across clinical sites, variability between subjects within a     given operator-device configuration, and variability within a subject for a single     operator-device configuration.   "
121711|NCT01692925|"     This trial is conducted in Europe. The aim of the trial is to investigate the     pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa     (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.   "
121712|NCT01692912|"     Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic     Arthritis to a target (disease activity score <2.6), or as per their routine care. The aim of     this study is to determine whether treating to a target results in greater disease     improvement than treating patients using routine care.   "
121713|NCT01692899|"     To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy     in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated     factors, and retention rates of possible second-line tumor necrosis factor α inhibitors     (TNFi).   "
121714|NCT01692886|"     This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal     serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured     1 month after the infant series, and to evaluate the acceptability of the safety profile of     13vPnC as measured by the incidence rates of local reactions, systemic events and adverse     events.   "
121715|NCT01692873|"     Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.      Most patients present at diagnosis a non resectable, locally advanced or metastatic disease,     with a median survival of 12 month.      The aim of this study is the identification of diagnosis biomarkers, predictive of the     therapeutic response.      This project investigate the use of molecular analyses applied to pancreatic tumor cells     collected by microbiopsy under ultrasound-endoscopy, and blood cells.   "
121716|NCT01692860|"     . The purpose of this study is to examine the effects of eating a larger amount of     dairy-based protein on risk factors for metabolic syndrome   "
121719|NCT01692821|"     Adequate perfusion and oxygenation is essential for the function of the inner retina.     Although it is known that oxygen tension is very well autoregulated in the retina, the     physiological mechanisms behind this regulation process are not fully explored. The     development of new instruments for the non-invasive measurement of oxygen tension in retinal     vessels now allows for the more precise investigation of these physiological processes. The     current study seeks to evaluate the retinal oxygen saturation in healthy subjects while     breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.   "
121720|NCT01692808|"     The purpose of this study is to determine if high doses of vitamin D3 administered orally as     adjunct therapy to children with Crohn's disease could improve the outcome of the disease.   "
121721|NCT01692795|"     Large randomised trials have shown that cardiovascular medications prescribed to patients at     high cardiovascular risk are effective in reducing the incidence of cardiovascular events.     Their use is recommended in the United Kingdom and international guidelines (e.g. the     National Institute of Clinical Excellence). However, these medications do not prevent     cardiovascular events in all patients and there is now a body of research investigating the     effects of cardiovascular medications on outcomes in myocardial infarction (MI), including     clinical presentation, infarct size and post-MI mortality. However, the independent effects     of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations     to many of the published studies in terms of their cardiovascular drug exposure data. This     project utilizes prospectively collected data on cardiovascular drug use, and links to MI     data from hospital and mortality records.   "
121722|NCT01692782|"     A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD).   "
121723|NCT01692769|"     Background: Trauma is a major cause of death in children and teenagers. When young patients     have suffered major traumatic injuries, they require intravenous (iv) fluids to keep their     blood vessels full and ensure blood flow to vital organs. Current fluid guidelines by     International Trauma Committees recommend either Normal Saline (NS) or Ringer's Lactate (RL)     as the fluid of choice for these patients. Although these solutions share some similarities     in their composition, there are also some significant differences in sodium, chloride and     lactate concentrations. Despite these differences in fluid composition, there has never been     a study comparing these two fluids in paediatric trauma patients to determine which is     optimal. In this study, the investigators aim to determine the optimal fluid choice for     trauma resuscitation of young patients.      Hypothesis: The investigators hypothesize that severely injured paediatric trauma patients     resuscitated with NS will have optimal blood sodium levels compared to patients resuscitated     with RL.      Methods: The investigators will study 50 paediatric trauma patients that will be randomized     so that half will randomly receive NS and half will receive RL as their only iv fluid for 24     hours. After 24 hours, the investigators will compare in blood the sodium level, the amount     of acid, and the concentrations of inflammation molecules in relation to those whom received     NS versus RL.      Expected Results and Significance: Maintaining optimal levels of these biochemical markers is     imperative in reducing morbidity and mortality in severely injured paediatric patients. If     significant differences are present, the investigators will be able to determine which fluid     is preferred and expect these data to complement current trauma resuscitation guidelines.   "
121724|NCT01692756|"     This research study is the first of its kind and will allow health care professionals and     researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)     injury leads to knee pain and disability and osteoarthritis. We also hope that this study     will be the beginning of new, more powerful and safer drugs to help patients with ACL     injuries heal sooner and return to sports or daily activities pain free. Study participants     will be recruited from the University of Kentucky and Vanderbilt University.      The purpose of this research is to gather information on how safe and effective Kenalog® is     in alleviating knee pain following ACL rupture.   "
121725|NCT01692743|"     Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine     has shown promise in patients with other chronic diseases; pilot testing in our patients with     inflammatory bowel disease demonstrated that the technology was feasible and improved     clinical outcomes.      The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should     improve outcomes for patients, improve access to care in areas with limited resources, and     decrease health care costs.   "
121726|NCT01692730|"     This trial will test the effectiveness of an enhanced web-based smoking cessation     intervention for student smokers at 2-year Community Colleges. Young adults continue to be     understudied, so more studies of cessation interventions are needed to generate an acceptable     level of strength of evidence regarding quit rates, particularly so for Community College     students for whom little data on cessation are available. Students (research subjects) will     be directed to one of two intervention websites with various levels of novel interactive and     social network features, including a variety of better-practice features recommended by     recent literature, and technologically advanced proactive features (e-mails, SMS texting, and     social networking).      Our study hypothesizes that students with access to an enhanced website will have higher     rates of self-reported intention to quit, a higher number of quit attempts at 6-months     compared to those in in a non-enhanced website. Overall, this study will evaluate evidence     for a novel enhanced cessation intervention model and will add to our understanding of     successful intervention with an understudied population of primarily young adult Community     College smokers. The intervention components will be replicable and, if effective, the     methodology is applicable across populations, and has the potential for broad public health     impact through improved delivery of effective stop smoking interventions via the internet.   "
121727|NCT01692717|"     The objective of this clinical study, randomized, crossover is to evaluate the     pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide)     Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and     Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum     concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.   "
121773|NCT01692119|"     The aim of the study is to investigate whether a continuous interdisciplinary intervention     improves medication adherence and leads to a reduction of hospitalizations and mortality in     elderly patients with chronic heart failure. The intervention, consisting of regular contacts     with the local pharmacy and weekly dosing aids, aims to improve medication adherence and     management.   "
121728|NCT01692704|"     An open label, prospective, non-randomized single arm study. Combination of two treatment     modalities - HAI with FUDR and systemic chemotherapy with cisplatin and gemcitabine.      Definition of the maximum tolerated dose (MTD) of intravenous gemcitabine in combination with     intravenous cisplatin and intra-arterial FUDR. Definition of safety and toxicity of this     combined regional and systemic treatment approach. Definition of the response rate after 3     months of hepatic intra-arterial chemotherapy with continuous infusion FUDR with or without     ligation of the right or left portal vein, in combination with 3 months of systemic cisplatin     and gemcitabine in patients with unresectable intrahepatic or hilar CCC.      A total of 9-18 patients are required. 3-6 patients per dose level. A maximum of three dose     levels (1 - 3) has been defined.      Statistical Methodology: Traditional 3+3 dosing algorithm to find MTD.        -  Trial with medicinal product   "
121729|NCT01692691|"     The purpose of this study is to determine whether dacarbazine and carmustine at the doses and     schedule used in this study will help to increase tumor shrinkage.   "
121730|NCT01692678|"     The purpose of this study is to find the optimal dose of trabectedin for Chinese patients     with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were     previously treated (in any order) with at least an anthracycline and ifosfamide containing     regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy     regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group     is superior to dacarbazine group (Part 2).   "
121731|NCT01692665|"     Ocular aberration may play a role in determining optical quality. Recently performed study     reported that ocular aberration of preocular tear film would be important factor in not only     diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this     study, the investigators will aim to prove the improvement of quality of vision via ocular     aberration changes indirectly after the proper treatment for moderate and severe meibomian     gland dysfunction. Also, the investigators will evaluate the changes of keratometric values     after treatment for moderate and severe meibomian gland dysfunction, which could be     demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.   "
121732|NCT01692652|"     Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative     dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular     symptoms, which are all associated with the constant release of inflammatory mediators. To     our knowledge, there has been no study on tear cytokine levels in MGD patients treated with     topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear     cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical     loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine     the concentration of inflammatory tear cytokines in patients with MGD and to compare the     changes in tear cytokine levels between topical loteprednol etabonate and warm compress     treatment group and warm compress only treatment group.   "
121733|NCT01692639|"     Acetaminophen is the first drug involved in voluntary drug poisoning. According to the     studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver     failure, and this poisoning is responsible of 10 percent of liver transplants each year in     these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk     factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly     correlated with factors predisposing socio-economic field are an important issue, including     the speed and appropriateness of care are key factors both in terms of reducing morbidity     mortality in socio-economic terms for the community.A nomogram defines a statistical     threshold from which the blood concentration of paracetamol has a significant risk of liver     toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a     toxic dose, but there is no consensus on whether or not to repeat this dosage during the     treatment, as the first result is beyond the threshold or not.The administration of the     antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a     protocol that can vary in different services.In the absence of clear guidelines, the question     of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion     if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it     possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the     curve, and thus enable the return home of the patient's somatic point of view (excluding     psychiatric care when is voluntary drug intoxication), with consequences in terms of costs     (hospital days) and duration of treatment?   "
121734|NCT01692626|"     When cancer patients are treated with the drug cetuximab they very often develop a rash.     Usually it appears on their face and back and other parts of the body. The rash looks like     acne and is treated with skin creams or antibiotics most of the time. The rash can become     very painful and cause patients to stop using cetuximab to treat their cancer, even if     cetuximab was helping fight their cancer.      Cetuximab is known to be a good drug to help treat cancer. This study will help us learn     about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for     their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel)     to see if it will help prevent the rash or keep the rash from getting worse. The     investigators also want to see how the rash affects patients and their quality of life.      Participants will be in this study for about four weeks if their rash does not get worse.     They will need to apply the study cream and placebo two times daily and answer quality of     life questionnaires during this study. Participants will also be seen by a dermatologist and     have pictures taken of their rash.   "
121748|NCT01692444|"     Airway remodelling is an abnormal tissue repair following bronchial inflammation, which     contributes to none reversible pathological features, such as bronchial and peri-bronchial     fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD)     and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in     the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the     recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain     unknown.      The main objective of the study is to analyse the distribution and quantify the number of the     peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD     compared to control subjects.   "
121749|NCT01692431|"     The primary aim of this study is to determine the impact of individual fish oil fatty acids     on vascular reactivity and to identify underlying physiological and molecular mechanism of     any observed effects. In addition response to intervention according to genotype will be     determined retrospectively.   "
121735|NCT01692613|"     Background:      The immediate endoscopic identification and diagnosis of intraepithelial structures and     immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet     goals in the diagnosis and management of subjects with food intolerances, who are negative to     all available tests. Endomicroscopy may be helpful to further visualize and characterize     unmasked small bowel reactions to foods, which has not been described before.      Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the     macroscopic view ,which enables the examiner to see immediate reactions after exposure and it     further allows capturing of fluid excreted by the gut for further analysis to understand the     pathology behind this reaction further.      N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and     negative testing with routine methods. Patients with Lactose intolerance n=10 patients to     compare results. Patients with Fructose intolerance n=10 patients to compare results.     Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the     Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain     (n=10) to serve as healthy controls for allergy testing.      Methods:      The primary objective is to investigate whether endomicroscopy will allow the detection of an     allergic reaction of the gut after exposure of the 5 major allergens in the following way:      After standard gastroscopy with the endomicroscope including evaluation of the surface of the     upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of     the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina     propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple),     allergen 5 (yeast).      The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in     the lamina propria of the duodenum, representing an acute reaction to one of the allergens     sprayed to its surface through the endoscope channel.   "
121736|NCT01692600|"     Radiation therapy of the head and neck cancer patients causes late oral radiation     complications such as xerostomia (dry mouth) or mucosal atrophy. Currently, methods such as     hyperbaric oxygen are used to treat these complications; however, there are no quantifiable     means of assessing the outcome of these methods. At present, subjective methods such as     superficial examination of the oral cavity are used, yet complications are known to mostly     start in the subsurface layers. In this feasibility study, we apply an imaging technique     called optical coherence tomography (OCT) as a means of providing objective and quantifiable     images of the subsurface micro-structural and micro-vascular changes of oral tissue.     Depth-resolved, micrometer-resolution OCT images provide information on changes associated     with late radiation complications.   "
121737|NCT01692587|"     The Purpose of the Protein Study is to investigate whether a reduced protein diet can inhibit     the growth of prostate cancer in humans.      The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes     that are involved in the growth of prostate cancer.   "
121738|NCT01692574|"     To determine whether individuals who suffer from depression and obesity are able to lose     weight and show improvements in mood and cardiovascular disease risk factors following 20     weeks of a combined treatment of cognitive-behavior therapy for depression and behavior     modification for weight loss. Participants will be assigned to one of three treatments: 1)     cognitive-behavior therapy for the treatment of depression combined with an alternative     approach to weight loss, 2) a weight loss intervention combined with a depression support and     education , or 3) cognitive-behavioral therapy for depression combined with a weight loss     intervention.   "
121739|NCT01692561|"     The purpose of this research study is to better understand what causes dysautonomia and how     this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous     system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms     of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of     anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic     tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to     standing, called orthostatic intolerance. We would like to learn more about the link between     orthostatic intolerance and nausea. While medications currently used to treat orthostatic     intolerance and nausea have proven to be effective in some patients, this may not be the best     treatment for everyone as long term use could pose certain risks including high blood     pressure. In order to provide a more focused and safer treatment for patients suffering from     nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and     certain blood tests change during a tilt table test. This test helps to create the same     circumstances that patients with orthostatic intolerance experience when they stand. To     better understand if some of these problems are associated with the brain, we will study MRI     in patients with dysautonomia compared to children without dysautonomia. This information may     allow us to use alternative and safer treatments in the future.   "
121740|NCT01692548|"     Forty children considered at risk for ADHD (subclinical ADHD) will be randomized to either a     neurofeedback intervention or waiting list.   "
121741|NCT01692535|"     In this multicenter study the investigators are going to evaluate the use of six different     videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with     intubation. The investigators are hypothesizing that these six videolaryngoscopes will     succeed for intubation at first attempt in at least 90% of all cases using a difficult airway     simulation with extrication collars. As gold standard, a standard Macintosh blade is being     used.      The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720     patients.   "
121742|NCT01692522|"     The investigators will evaluate the first attempt visualized blind intubation through an Ambu     Aura-i versus an AirQ.   "
121743|NCT01692509|"     The practices and processes related to the administration of noninvasive ventilation (NIV) in     the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded     by an investigator at the bedside. The effect of the NIV treatment on various respiratory     parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be     recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be     evaluated.   "
121744|NCT01692496|"     Soft tissue and bone sarcomas are rare malignant tumors, which encompasses a large family of     more than 50 histologically distinct tumor subtypes, all of which share a putative     mesenchymal origin. In the case of soft tissue sarcomas (STS) surgical excision is the     mainstay of treatment, but despite curative surgery, around half of patients develop distant     metastases and die from disease. Few therapeutic approaches are currently available to     patients with unresectable, locally advanced, or metastatic STS and only anthracyclines,     ifosfamide and trabectedin have shown activity, with response rates of 20-40% in previously     untreated patients. Recent and ongoing trials have investigated a variety of combination     chemotherapeutic regimens (variously employing ifosfamide, doxorubicin, gemcitabine,     temozolomide, vincristine, cisplatin, and dacarbazine, among others) as well as targeted     therapies, which in some cases have yielded improvements in response rate but which have had     little impact on survival. No other medical option is currently available, and the median     survival of patients with soft-tissue sarcoma with non-resectable metastases is around 12-15     months, and approximately 8 months after second line chemotherapy.      Liposarcomas are STS which account for at least 20% of all STS in adults. They can be further     classified into 3 histologically and biologically different subtypes: well-differentiated     liposarcoma/dedifferentiated liposarcoma (ALT-WD), myxoid or round cell liposarcoma and     pleomorphic liposarcoma.      ALT-WD liposarcomas are locally aggressive rarely metastasizing tumors characterized by ring     or giant marker chromosomes on the cytogenetic analysis and by amplification of the 12q13-21     region on FISH (MDM2, CDK4 and HMGIC). They account for about 40% iv of liposarcomas with a 5     year OS around 80%. In a series of WD/DD treated with several regimens response rate was     12.5% OS 15 months and median PFS 3.6 months(95 CI: 3.3-5.9) Mixoid /round cell liposarcoma     accounts for 45-50% of all liposarcomas. They tend to metastasize to unusual soft tissue and     bone locations. High histologic grade with more than 5% of round cell component is associated     with a 5-year OS of 50% approximately. They are characterized by t(23;16)(q13-14;p11) which     leads to the fusion of CHOP and TLS genes Pleomorphic liposarcoma accounts for approximately     5-10% of all liposarcomas, characterized by high grade features with frequent and early lung     metastasis and cytogenetically by high chromosome counts and complex structural     rearrangements.      VEGF is expressed in many STS in which increased expression is associated with higher grade     and worse prognosis.      Pazopanib is an oral angiogenesis inhibitor that targets mainly VEGFR, PDGFR and c-kit.     Recently the results of a phase II trial of pazopanib in STS have been published. It was a     four-cohort 2-stages study. The liposarcoma stratum was closed after the first stage because     of a PFS at 12 weeks of 17% (3 out of 17 patients did not progressed after 12 weeks). After     central pathologic review, 2 other patients initially classified as other STS were found to     have liposarcoma with stable disease at 12 weeks (5/19: 26% PFS12w), thus fulfilling criteria     for cohort expansion. Phase II study had been completed and in phase III study patients with     liposarcomas were excluded so therefore data on the liposarcoma cohort are inconclusive.      Furthermore the positive results of the phase III study PALETTE have been recently     communicated, encouraging this treatment in other sarcomas: progression-free survival (PFS)     per independent review was significantly prolonged with pazopanib (median: 4.6 vs 1.5 months;     HR=0.31, 95% CI 0.24-0.40; P<0.0001). The interim analysis for overall survival shows a     statistically non-significant improvement of pazopanib vs placebo (median: 11.9 vs 10.4     months, HR=0.83, 95% CI 0.62-1.09).      Soluble factors associated with efficacy and toxicity of pazopanib in these patients had been     also reported. Decreases in VEGFR2 and increase in PlGF were both associated with toxicity     (HTA and TSH elevation) and poorer prognosis.   "
121745|NCT01692483|"     The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in     male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC)     who have received prior chemotherapy containing a taxane.   "
121746|NCT01692470|"     The purpose of this study is to assess the safety and effectiveness of rilpivirine     hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment     of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human     immunodeficiency virus type 1 (HIV-1) infection.   "
121747|NCT01692457|"     The purpose of this study is to assess the safety and effectiveness of golimumab for the     treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among     Filipino patients.   "
125094|NCT01648270|"     The purpose of this study is to see how healthy volunteers bodies handle buprenorphine.   "
121750|NCT01692418|"     Anaemia is a common problem in patients undergoing surgery. About half of patients undergoing     a major operation have anaemia, often a consequence of the disease requiring surgery. Anaemia     causes patients to feel tired and unwell. Anaemia at the time of surgery increases the     requirement for blood transfusion (50% if anaemic compared to only 15% without anaemia). Both     anaemia and blood transfusions are associated with increased complications from surgery,     delayed recovery and prolonged hospital stay. The investigators propose that giving     intravenous iron before operation can be used to correct anaemia in these patients.     Consequently if patients are not anaemic they are less likely to need blood transfusion. Also     patients feel better and their health is improved before their operation they are more likely     to tolerate the surgery, recover faster, be less likely to have complications from surgery     and return home sooner. This will have benefits to the individual patient and also to the NHS     by reducing costs.      Oral Iron tablets are not effective as they take 3-6 months to increase blood levels, the     tablets are often not tolerated as cause constipation or stomach pain, overall only 30-50% of     people continue taking oral iron. A full treatment dose of intravenous iron can be given in     15 minutes with minimal side effects. The effect is to rapidly increase blood counts in 2-4     weeks. The investigators propose that this treatment can be incorporated to patient     preparation pathways for surgery as an outpatient without the need for additional visits to     hospital.      Small studies have suggested a benefit of iron therapy in orthopaedic and gynaecological     surgery. This study will look at 500 patients undergoing major surgery at 20 hospitals in the     UK. The investigators anticipate half of patients treated will have their anaemia corrected     before operation. Patients with anaemia will be identified as part of the routine blood tests     taken preoperatively and invited to take part in the study. Following informed consent, they     will be randomly allocated to receive either intravenous iron or a placebo infusion of     saline. Intravenous iron is a dark liquid given continuously into a vein over 15 minutes. To     ensure neither doctor nor patient knows which treatment is being given both infusions will be     prepared and administered by an unblinded authorised person via a black bag through black     tubing. There will be no other changes to the patient's normal treatment.      The main aim of this study is to assess if intravenous iron will reduce the need for blood     transfusion in the time period around the operation. Further outcome measures will include;     patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes     will be assessed both during hospital stay and after the patient has been discharged. The     trial will be run through a Clinical Trials Unit with considerable experience in conducting     large trials. The team has a large range of experience in anaemia management and assessment     of complications, quality of life and the cost of health care.      The main aim of this study is to assess if intravenous iron will reduce the need for blood     transfusion in the time period around the operation. Further outcome measures will include;     patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes     will be assessed both during hospital stay and after the patient has been discharged. The     trial will be run through a Clinical Trials Unit with considerable experience in conducting     large trials. The team has a large range of experience in anaemia management and assessment     of complications, quality of life and the cost of health care.   "
121751|NCT01692405|"     Performance evaluation of a novel, semi-automated device and method for needle core biopsy     download compared to standard methods in terms of:        1. Biopsy core length obtained (i.e. collecting all tissue fragments)        2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)        3. Pathologist interpretability        4. Processing time        5. Prostate cancer detection.   "
121752|NCT01692392|"     The purpose of the study is to assess changes in health-related quality of life in patients     undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term     effects of surgical intervention in relation to the development of persistent postoperative     pain and / or sensory disturbances in the surgical field.   "
121753|NCT01692379|"     To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is     superior to medical management alone in achieving favorable outcome in the distribution of     the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel     ischemic stroke < 8 hours from symptom onset.   "
121754|NCT01692366|"     Primary Objective:      - To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 and     combined for the response rate defined with the ≥35% reduction of spleen volume as determined     by magnetic resonance imaging (MRI or computed tomography scan [CT] in patients with     contraindications for MRI).      Secondary Objectives:        -  To evaluate the safety of SAR302503 for both pooled (300, 400, and 500mg) and individual          doses population.        -  To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat-dose.        -  To evaluate the effect on Myelofibrosis (MF)-associated symptoms (Key MF symptoms) as          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF).        -  To evaluate the durability of splenic response.        -  To evaluate the effect of SAR302503 on bone marrow with regard to changes on reticulin          fibrosis.   "
121755|NCT01692353|"     This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to     compare selected CVD biomarker data between subjects who were long-term consumers of     cigarettes or moist snuff and non-consumers of tobacco and b) to identify principal endpoints     related to CVD risk that differed among the three tobacco-use cohorts. The following     assessments provided the primary study endpoints for comparative analyses between the     cohorts:        1. CVD-related physiological assessments: Flow-mediated dilation (FMD), carotid          intima-media thickness (CIMT), ankle-brachial index (ABI), spirometry and expired carbon          monoxide (ECO).        2. CVD-related biomarker assessments in blood and urine (biomarkers of tobacco effect).        3. Biomarkers of tobacco exposure in urine and blood.   "
121756|NCT01692340|"     Tomatoes contain several compounds which may be beneficial for human health and prevention of     disease, although this relationship is poorly understood and very controversial. This study     uses a new technology to study the absorption and metabolism of three different compounds     found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We     hypothesize that by studying the absorption and metabolism of these compounds, we may be able     to understand how the compounds may influence health and disease processes.   "
121757|NCT01692327|"     The hypothesis of the proposed project is that after a fat overload, the postprandial     response is different in both groups, suggesting that the LPP will present the most     significant damage in endothelial vasomotion in obese individuals, especially those with GI     and T2DM. After the fat overload, we hypothesized that there will be a worsening of     endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but     also find lower concentrations of incretins in OB/DM2 group compared to other groups.      These hypotheses may be confirmed by techniques for evaluating microvascular function, the     use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic     and cardiovascular read by Multiplex kit.   "
121758|NCT01692314|"     The purpose of this study is to investigate the effect os resistance training on     microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart     rate, body composition and physical fitness in obese adolescents.   "
121759|NCT01692301|"     The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central     Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial     stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened     pulse pressure (PP).   "
121770|NCT01692158|"     The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics     parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following     administration of single subcutaneous dose. The objective of this randomized, crossover,     clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T     produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by     Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa),     as surrogate markers for their circulating concentrations of the drug.   "
121760|NCT01692288|"     The purpose of this study is to determine if children and mothers who participate in the     First Born® Program (FBP) experience better outcomes than they would have in the absence of     the program. The evaluation employs a randomized trial design to assess the effectiveness of     the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses     clinically trained professionals to provide first-time parents with information, training,     and access to resources designed to promote early childhood development. Services are free     and may begin at any time during pregnancy or up to two months after the baby's birth and may     continue until the child is three years old. In addition, a nurse postpartum home visit is     offered to the parents of all participating newborns. The FBP model builds on other home     visiting and prevention programs that have been shown to improve long-term outcomes of     children and their families.   "
121761|NCT01692275|"     The purpose of this study is to evaluate the effectiveness of chiropractic manipulative     therapy for pain management and improved function in active duty service members with low     back pain that do not require surgery. The study will also measure the impact of a tobacco     cessation program delivered to participants allocated to the chiropractic arm.   "
121762|NCT01692262|"     To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy,     in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated     in patients who have progressed after chemotherapy (Part A) and in patients who have     progressed before receiving chemotherapy (Part B).      Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently     being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational     anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off).      Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having     an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients     on a dose and schedule selected from Part A.   "
121763|NCT01692249|"     To determine whether spa therapy has a beneficial effect on pain and disability in the     management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized     prospective clinical trial includes patients with shoulder pain due to chronic degenerative     rotator cuff tendinopathy who attend French spa resorts as outpatients. Subjects are     randomized into two groups: immediate spa therapy (18 days of standardized treatment) and     control (spa therapy delayed for 6 months). All patients continue usual treatments during the     6-month follow-up period. The main endpoint is the mean change in the DASH score at 6 months.     Secondary endpoints are the mean change in SF-36 components, treatments used, and tolerance.     The effect size of spa therapy is calculated and the proportion of patients reaching minimal     clinically important improvement (MCII) is compared between groups.   "
121764|NCT01692236|"     Background:      - Human immunodeficiency virus (HIV) infection appears to cause problems with blood vessel     function. These problems may add to some thinking and mood disorders found in people with HIV     infection. Researchers want to evaluate HIV infected patients to see if blood vessel function     contributes to thinking and mood disorders, such as early dementia and depression. To do so,     they will compare study results between people with and people without HIV infection.      Objectives:        -  To compare the thickness of blood vessel walls between people with and without HIV          infection.        -  To study the relationship between blood vessel thickness and thinking and mood          disorders.      Eligibility:        -  Individuals between 25 and 55 years of age who have HIV infection.        -  Healthy individuals between 25 and 55 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have imaging studies of the brain and major blood vessels in the head          and neck.        -  Participants will also have neuropsychological testing. These tests will look at memory,          learning and thinking ability, attention, and mood.        -  Participants will have the option of coming back for repeat blood tests every six months          and repeat imaging studies and neuropsychological tests every year, over 1- 4 years          period.   "
121765|NCT01692223|"     This study uses new methods called genome sequencing that allow the investigators to study     part or all of a person's genome. The genome is the collection of all of a person's genes.     Genes carry the instructions that our bodies need to develop and function. Genes are passed     on from one generation to the next. Genome sequencing can study all of a person's genome     (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the     study, the investigators refer to all these research methods as 'genome sequencing'. Genome     sequencing typically shows a large number of gene changes, known as variants. Some (but not     all) of these genetic variants may be linked to increased risks of diseases other than     cancer.      The purpose of this study is to learn what kinds of genetic variants the patient wants to     learn about from their genome.   "
121766|NCT01692210|"     The goal of this research study is to learn about how dexmedetomidine (a standard of care     sedative) affects your immune system (your defenses against cancer) by measuring your white     blood cell levels before and after surgery.   "
121767|NCT01692197|"     The goal of this clinical research study is to learn if E7070 in combination with idarubicin,     cytarabine, and dexamethasone can help to control the disease in patients with either AML or     high-risk MDS that has relapsed. The safety of the drug combination will also be studied.   "
121768|NCT01692184|"     This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and     pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate     the effect of food on the pharmacokinetics of a single oral dose of AVL-292.   "
121769|NCT01692171|"     The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics     parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following     administration of single intravenous dose. The objective of this randomized, crossover,     clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T     produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by     Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa),     as surrogate markers for their circulating concentrations of the drug.   "
121771|NCT01692145|"     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to     placebo in patients with dry eye syndromes.   "
121774|NCT01692106|"     This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there     is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline     pressure in the LES. The most widespread treatment for this disease and the one that has the     best long term results involves cutting the muscle layers of the lower esophagus and on the     neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal     wall. This is done during a surgery through the abdomen either with a big incision or more     recently with the keyhole technique. This surgery has various potential complications, one of     which being making a hole through the mucosa or not extending the cut on the muscle long     enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM)     is a new intervention that is done also under general anesthesia in the operating room;     however, it involves no skin incisions and all the procedure is done through a fiber optic     camera. It involves making a cut in the inner layer of the esophagus and then with cautery     cut the muscle fibers responsible of the blockage and finally closing the initial opening     with clips. In this study we will investigate the feasibility of this intervention both from     a technical aspect as well as a logistical perspective given the local operating room     constraints.   "
121775|NCT01692093|"     The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic     dermatitis.   "
121776|NCT01692080|"     The primary objective of this study is to document the prevalence and associations between     asthma, hypertension, and obesity in children living in Pittsburgh, Pennsylvania and its     surrounding regions.      The secondary objective is to determine the impact of various educational interventions on     child and caregiver knowledge of asthma.   "
121777|NCT01692067|"     The purpose of this study is to determine potential risk factors for physical and sexual     assault in regular military women (as opposed to Reserve and National Guard). In addition,     this study seeks to determine associations between service women's violence exposures and:     current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and     civilian healthcare.   "
121778|NCT01692054|"     The aim of the study is to improve the prognosis of the development of alcohol consumption by     considering a variety of biological, psychological and social risk and protective factors.     Therefore, young people who have been hospitalized due to acute alcohol intoxication within     the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired     psychosocial development. The study will also include a control group of young adults who     were in hospital due to other medical conditions. The identification of relevant cases will     be based on medical records of several children's hospitals. These records will be analysed     with regard to potential predictors of developmental hazards and protective factors.   "
121779|NCT01692041|"     The trial aims to record possible effects of a supplementary treatment with ivy leaves dry     extract on different lung function parameter, on bronchial hyperreactivity, on individual     markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is,     that the additional therapy might improve these parameters and might help to optimize asthma     therapy.   "
121780|NCT01692028|"     Hypothesis: low vitamin D status is associated with increased insulin resistance and     increased blood pressure.      Approach: Multiple regression analysis of information extracted from a large database     accumulated by a Canadian health foundation, specifically evaluating statistical associations     between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure,     after adjusting these variables for BMI, age, sex, and waist circumference.   "
121781|NCT01692015|"     Hereditary Haemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this     study is to provide data regarding the diet and nosebleed frequency using a questionnaire.      This will be filled in by people with HHT.      The questionnaire has been designed in paper format.   "
121782|NCT01692002|"     The aim of these studies is to firstly determine the pharmacokinetic profile of orally     administered enteric coated sodium propionate. Subsequently, the most efficacious dose at     improving glucose tolerance following an oral glucose challenge will be determined. The     investigators will then determine the mechanism of action of propionate, whether it acts by     altering beta cell function directly or by augmenting the incretin effect or both   "
121783|NCT01691989|"     This multicenter, randomized, double-blind, placebo-controlled study will assess the     efficacy, safety and tolerability of aleglitazar compared with placebo when added to a     sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with     type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or     sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150     mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.   "
121784|NCT01691976|"     MCI with ageing is thought in part to be related to reduced serum sex hormones which is     well-recognised, especially in females, but poorly understood. International studies     assessing hormone replacement therapy (HRT) to prevent/reduce MCI are ongoing. MCI leads to     morbidity, reduced quality of life and substantial healthcare costs. The commonest     therapeutically induced reduction in sex hormone level in men is treatment of prostate cancer     (PCa). PCa is androgen dependent and androgen-deprivation therapy (ADT) suppressing     testosterone to castrate levels is key therapy for advanced disease. About one million men     worldwide have received ADT for PCa, mostly using luteinising hormone releasing-hormone     agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps 4% of     Caucasians may be castrated. MCI as a side-effect of castration in men remains poorly     researched. This pilot study will quantify the extent of MCI in men receiving ADT with LHRHa     and oestrogen to inform the design of a larger study to understand mechanisms, predict     affected patients and determine ways of reducing MCI. Researching relationships of sex     hormones and MCI should improve understanding and interventions for slowing/preventing MCI in     PCa survivors. HRT in women slows MCI. Alternatives for ADT include parenteral oestrogen. The     PATCH clinical trial comparing transdermal oestrogen with LHRHa offers an opportunity to     assess oestrogen as preventative for male MCI. Functional magnetic resonance imaging (fMRI),     quantitative electroencephalography (qEEG) and neuropsychological tests will be used to test     this hypothesis.   "
122416|NCT01683747|"     The premise of this study is that enteral tranexamic acid will help to maintain small bowel     integrity, which is often compromised by critical illness due to inadequate cardiovascular     perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease     morbidity in critically ill patients.   "
121785|NCT01691963|"     Usually videolaryngoscopy using a videolaryngoscope with a classic Macintosh design is     performed with the blade in the vallecula and the epiglottis elevated from the vocal cords     indirectly, as in direct laryngoscopy. However, during an audit of videolaryngoscopic     practice we noticed that, in obtaining the best view, clinicians frequently and inadvertently     advanced the blade into the vallecula to get a better view, such that the epiglottis was     downfolded and elevated directly from the vocal cords. However, a better view does not     necessarily lead to higher intubation success.      In this randomized, controlled trial, we want to determine the efficacy of     videolaryngoscope-guided tracheal intubation using an alternative position for the blade in     patients with normal airways.   "
121786|NCT01691950|"     This is an observational study, which aims to firstly develop a sensor-based objective     mobility assessment. This will then be used to profile and compare the outcomes of patients     who undergo amputation with those who have limb salvage surgery following a traumatic injury     to their lower limb.   "
121787|NCT01691937|"     Patients often experience moderate to severe postoperative pain, especially during the first     hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be used     after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et al.     2005), but the analgesic effect can be limited and undesirable side effects may occur.      A case report described that right thoracic paravertebral block reduced pain and analgesic     requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural     analgesia, thoracic paravertebral block probably carries a much lower risk of spinal     haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist     1998; Karmakar 2001).      We therefore designed a prospective, randomized, subject and assessor blinded,     parallel-group, placebo controlled study to test the hypothesis that continuous right     thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after     right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with     sufentanil.   "
121788|NCT01691807|"     The purpose of this study is to evaluate the potential drug-drug interactions between     ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell     non-Hodgkin's lymphoma (NHL).   "
121789|NCT01691794|"     The purpose of this study is to collect safety clinical data in HIV-infected pediatric     patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are     receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse     transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.   "
121790|NCT01691781|"     This study will evaluate whether commonly used blood pressure medications called ACE     inhibitors can lower parathyroid hormone.   "
121791|NCT01691768|"     The purpose of this study is to assess the effectiveness of an implementation model which     integrates tenofovir gel provision into existing family planning services.   "
121792|NCT01691755|"     This multicenter, randomized, double-blind, placebo-controlled study will assess the     efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in     patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic     therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily     or placebo. The anticipated time on study treatment is 26 weeks.   "
121793|NCT01691742|"     A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate     postoperative period following pelvic reconstructive surgery in women taking routine docusate     sodium.      B. Objectives        1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between          MiraLAX versus placebo in women receiving routine docusate sodium after pelvic          reconstructive surgery.           Specific Aim 2: To compare patient reported outcomes of BM quality and associated          gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool          scale and the validated Patient Assessment of Constipation Symptom Questionnaire          (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive          surgery.           Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo          utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire          (PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive          surgery.        2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent          constipation following pelvic reconstructive surgery by decreasing time to first BM,          decreasing GI symptoms associated with constipation, and increasing measures of          GI-related quality of life, while minimizing the bothersome side effects associated with          stimulant laxatives.   "
121794|NCT01691729|"     To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory     products.   "
121795|NCT01691716|"     The purpose of this study is to determine whether Tendoactive, eccentric training, or the     combination or both could be effective in the treatment of Achilles tendinopathy.   "
121796|NCT01691703|"     A difficult tracheal intubation can be a problem, even if one has taken all precautions. A     possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation     scope. As such, the videolaryngoscope can be used to achieve the best possible view and space     of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.   "
121797|NCT01691690|"     Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate     pain for pediatric patients. Its common use (particularly in oral form) is underscored by its     wide therapeutic window, safety profile, over the counter accessibility, lack of adverse     systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses.      Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated,     these mechanisms appear to be multi-factorial and include central inhibition of the     cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from     arachidonic acid, interference with serotonergic descending pain pathways, indirect     activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through     N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known     is that of central inhibition of COX enzymes by which the decreased production of     prostaglandins diminish the release of excitatory transmitters of substance P and glutamate     which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011).      To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric     population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al,     2009; Hong et al, 2010).   "
121798|NCT01691677|"     Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As     adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400     μg twice daily, was well tolerated and significantly more effective in reducing the symptoms     of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone     propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical     success rates and accelerated recovery of patients with a history of chronic rhinitis or     recurrent sinusitis who present for treatment of acute rhinosinusitis.      The present study was planned to assess the effects of nebulised beclomethasone dipropionate     given as add-on therapy to standard care (oral antibiotics) in the treatment of acute     symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.   "
121799|NCT01691664|"     Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy     uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive     cellular therapy after surgery may be more effective than uses radiation therapy alone in     treating esophageal cancer.   "
121800|NCT01691651|"     The purpose of this study is to associate the use of botulinum toxin type A for patients with     keratoconus to demonstrate that tension eyelid has an important role in disease progression.   "
121801|NCT01691638|"     (A retrospective case control study to validate the association between Interleukin-1 gene     variations and adult chronic periodontal disease in European Caucasians)   "
121802|NCT01691625|"     The purpose of this study is to show if the adoptive cellular therapy with autologous     dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent     chemoradiation could improve the quality of life of the patients with locally advanced     esophageal cancer, compared with concurrent chemoradiation only.   "
121803|NCT01691612|"     Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil     survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal     pathways in multiple cells in asthma.   "
121804|NCT01691599|"     The objectives of this study are to investigate infection rates and management for open and     closed tibia fracture subjects in India treated with internal fixation. These objectives will     be carried out by answering the following questions:        1. What is the infection rate within one year of surgery for open and closed tibia fracture          subjects in India treated with internal fixation?        2. What is the distribution of infection per type of infection, stratified by time (early,          delayed, late) and location (superficial or deep) in open and closed tibia fracture          subjects in India treated with internal fixation?      Secondary objectives        1. How are infections managed in open and closed tibia fracture subjects in India treated          with internal fixation?        2. What is the treatment outcome for open and closed tibia fracture subjects in India          treated with internal fixation?        3. What is the influence of the following clinic and subject factors on the occurrence of          infection within one year for open and closed tibia fracture subjects in India treated          with internal fixation?             1. Hospital standard hygienic and antibiotic protocol for infection prevention             2. Subject demographics             3. Time between injury and surgery and between admission and surgery             4. Fracture type (AO Müller classification)             5. Soft tissue damage (according to the Tscherne classification for closed fractures               or Gustilo classification for open fractures)             6. Fracture management and implant type             7. Surgical details such as duration of surgery        4. Is there a difference in health-related quality of life as measured by the EuroQol-5          Dimensions (EQ-5D) between subjects with and without infections?        5. Is there a difference in the number of complications not related to infection (adverse          events and serious adverse events) between subjects with and without infections?   "
121805|NCT01691586|"     A relatively new and promising development in the area of cardiovascular implantable     electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the     device automatically and send the data from the patients' home to the physician, thereby     reducing in-clinic follow-ups.      The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus     in-clinic follow-up only on patient-reported health status and device-acceptance after     implantation with an implantable cardioverter defibrillator (ICD) or cardiac     resynchronization defibrillator (CRT-D).      Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic     visits or vice versa due to specific clinical and psychological factors and (2) To     investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic     follow-up only.   "
121806|NCT01691573|"     The main objective of the European Pediatric Catheter Ablation Registry is to collect data on     ablation procedures in the European pediatric population in order to improve the management     of this subset of patients.   "
121807|NCT01691560|"     The purpose of this exploratory study is to compare the treatment effect on dentinal     hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile     sensitivity. This proof of concept study will compare the test dentifrice with three other     treatment groups.   "
121808|NCT01691547|"     This is a double-blind, single dose (four inhalations), four-way cross over study in healthy     subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics     (PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will     be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a two     strip configuration. The NDPI will be configured with different combinations of each compound     and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI device.     Study drug will be administered through the inhaled route to healthy subjects in single doses     (four inhalations). Each subject will receive treatment in a randomized order Treatment A FF     (400 microgram [µg]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg) and VI (100     µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and UMEC (500 µg)     over four treatment periods. Each treatment period will be separated by a washout of 7 to 21     days. After the four treatment periods, a follow up visit will take place 7 to 21 days     following the final dose of study medication and the maximum duration a subject will be     involved in the study is eighteen weeks.      Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of     FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart     rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected     throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and     clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout the     study.   "
121809|NCT01691534|"     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral     administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824     plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus     Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as     per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log     CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary     tuberculosis (TB). A control group will receive standard treatment.   "
122417|NCT01683734|"     The purpose of this study is to monitor the renal function of patients who have an antibiotic     laden spacer in place to treat an infected hip or knee arthroplasty.   "
121810|NCT01691521|"     This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg     subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in     subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be     measured by a reduction in the frequency of asthma exacerbations. Additional efficacy     assessments will include measurements of lung function, symptom scores, and quality of life.     Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse     events.      This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588,     who meet all eligibility criteria at screening visit, will enter the run-in period. Those     subjects that are not able/eligible to be randomised at the end of the 6 week run-in period     will be deemed run-in failures. Subjects will remain on their current maintenance therapy     throughout the run-in, double-blind treatment administration and follow-up periods. Subjects     who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to     receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75     miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v.     and placebo SC.      Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility     criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to     participate in the OLE trial.   "
121811|NCT01691508|"     This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of     mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects     with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase     (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase     (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase     (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS     (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a     review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase     subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100     mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing     maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction     Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to     achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the     Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks     and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule     based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation     history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance     Phase subjects will be maintained without any further OCS dose adjustment. Subjects who     complete the 24 week double-blind period and meet the eligibility criteria, will be offered     the opportunity to participate in an open label extension (OLE) study otherwise they will     return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment.     At each clinic visit, adverse events, safety labs, spirometery parameters and exacerbations     will be assessed. The pharmacokinetic samples will be collected in the beginning of the     treatment, prior to last dose, at the end of study (exit visit) and the follow up.   "
121812|NCT01691495|"     Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic     disease. It has recently been approved in the European Union (EU) for the treatment of     patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein     thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed     to evaluate physicians' adherence to fondaparinux prescribing information regarding proper     diagnosis and dosing for the treatment of SVT.      The primary objective is to evaluate physicians' adherence to fondaparinux prescribing     information for the treatment of patients with SVT without concomitant DVT.      The study is designed as a non-interventional, retrospective chart review of patients     prescribed fondaparinux to treat their SVT. The study will be conducted in several EU     countries.      ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.   "
121813|NCT01691482|"     The objective of this study is to assess the daily variation in bronchodilator response to an     inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting     anticholinergic (ipratropium) individually and when used in combination in subjects with     COPD.   "
121814|NCT01691469|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
121815|NCT01691456|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
121816|NCT01691443|"     The objective of this study is to investigate the effect of vibration feedback on the     gripping pressure in the territory of the median nerve.   "
121817|NCT01691430|"     Urinary tract infection (UTI) is the most common infection in nursing home residents, and     bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting.     The primary aim of this study is to test the efficacy of two oral cranberry capsules per day     in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will     be accomplished by conducting a double blind randomized placebo controlled efficacy trial of     two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing     home residents.   "
121818|NCT01691417|"     Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and     its influence on cardiac activity in healthy subjects, the investigators expect to improved     cardiac function in patients suffering from congestive heart failure.   "
121819|NCT01691404|"     Flavonoid-rich foods such as tea and cocoa have been identified as having a blood     pressure-lowering effect. Part of this effect is thought to be due to the flavonoid content     of these foods although it is currently unknown which flavonoids play a role. Epicatechin is     one the major flavonoids in cocoa while quercetin is largely found in tea.      During this study the investigators plan to investigate the effects of pure epicatechin and     quercetin supplementation on vascular function and blood pressure in untreated     (prehypertensive) subjects by way of a three-armed double-blind crossover intervention.     Participants will sequentially consume supplements containing quercetin, epicatechin or     placebo for a period of 4 weeks. Before and after this 4 week period, measurements of     vascular function and blood pressure will be taken.      The investigators hypothesize that the supplementation of epicatechin and quercetin will     improve vascular function and blood pressure.   "
121847|NCT01691040|"     This study is conducted to determine the safety, tolerability, and efficacy of NOX-H94 in     patients with anemia of chronic disease (ACD). Furthermore, this study is intended to provide     data needed to correlate plasma concentrations of NOX-H94 with its efficacy and to choose the     appropriate dose and dose schedule of subsequent efficacy studies.      Some chronic diseases, e.g. tumors, inflammation, renal disease, are associated with high     hepcidin concentrations in the blood. These hepcidin concentrations cause a reduction in iron     concentrations in the blood and subsequently impair formation of red blood cells. Treatment     with NOX-H94 is expected to inhibit this patho-mechanism by binding and inactivating     hepcidin.   "
121820|NCT01691391|"     3rd line standard treatment of patients with metastatic colorectal cancer (CRC) harboring     K-ras wild type consists of anti-EGFR treatment with either cetuximab or panitumumab. This     type of treatment has a modest but significant beneficial activity in this patient group with     improved progression-free and overall survival. Although it is well known that patients with     advanced CRC harboring a K-Ras mutation will not respond to anti-EGFR treatment, it is not     understood why patients with K-Ras wild type CRC do not all benefit from this type of     therapy. In order to optimize treatment of these patients as well as health care costs, it is     extremely important to identify those patients who will respond to treatment with an EGFR     inhibitor at an early stage.      The investigators hypothesize that the differences in response to treatment with cetuximab     are due to variability in the pharmacokinetics and -dynamics of the antibody. Thus, the     investigators hypothesize that patients who do not respond to anti-EGFR treatment, have     insufficient drug levels in tumor tissue. The investigators hypothesize that this is due to     pharmacodynamic processes such as sequestration of cetuximab in the liver which expresses     high levels of EGF receptor.      With the introduction of immuno-positron emission tomography (PET), an attractive novel     option to visualize molecular interactions has been developed using the combination of PET     with labeled mAbs. Cetuximab labeled with zirconium-89 (89Zr) has been successfully generated     (GMP) and is available for this study. Previous studies have shown excellent stability of     this compound and 89Zr is shown to be safe in humans. The investigators will use     89Zr-cetuximab to demonstrate tumor targeting by imaging and explore the relation of uptake     with treatment response. With this approach the investigators hope to achieve a better     understanding of the mechanisms of action of this therapeutic mAb in metastasized CRC and     eventually develop strategies that may improve efficacy of cetuximab treatment.   "
121821|NCT01691378|"     The purpose of this project is to provide further evidence regarding a groundbreaking     psychological treatment for suicide prevention in individuals with moderate to severe     traumatic brain injury (TBI), Window to Hope (WtoH). The study will be one of the first five     randomized clinical trials (RCTs) internationally to evaluate a psychological treatment for     affective distress after TBI and the first conducted in the United States (U.S.) to     specifically address suicide risk as an outcome.      The current project aims to adapt WtoH for U.S. military personnel/Veterans (expert Consensus     Conference, participant total up to 15), implement the intervention in a VAMC (Pilot Groups     1-4, participant total up to 12), and replicate the results from the original trial in this     novel context with a larger sample size (n=70 completed protocols [up to 90 recruited].     Deliverables are expected to include an intervention suitable for both dissemination and     larger Phase III trials.   "
121822|NCT01691365|"     Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can     offer significant protection against infections and cardiovascular disease (CVD) especially     in diabetic patients. The proposed study will determine whether improvements in antioxidants     and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead     to a clinical benefit   "
121823|NCT01691352|"     Countless children undergo surgery annually for management of what clinicians consider to be     a dirty wound. One frequently encountered example is the ostomy reversal. During this     planned operation, the previously diverted small bowel or colon is reconnected with the     distal intestine, restoring continuity. However, this procedure leaves an open wound on the     anterior abdominal wall, creating a conundrum for the surgeon and raises the question: how     should the wound be managed? In the investigators practice at CHOA, surgeons utilize both a     wick and a non-wicked wound dressing. In this prospective randomized trial, we wish to     evaluate these two dressings in children receiving an ostomy closure. The investigators     hypothesis is that the incidence of wound infection after ostomy reversal is the same     regardless of if a wick is placed or not.   "
121824|NCT01691339|"     The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18     years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to     <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).      Primary Objective:        -  To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal          vaccines in adults 18 to < 65 years of age and the safety of the 2012 - 2013 formulation          of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.      Observational Objectives:        -  To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone          Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the          2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years          of age.        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone,          Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the          requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance          (NfG) CPMP/BWP/214/96.        -  To submit remaining available sera from subjects given Fluzone vaccine to the Center for          Biologics Evaluation and Research (CBER) for further analysis by the World Health          Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food          and Drug Administration (FDA) to support selection and recommendation of strains for          subsequent years' influenza vaccines.   "
121825|NCT01691326|"     The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone     vaccine.      Objective:        -  To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in          a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices          (ACIP) recommendations, in children 6 months to < 9 years of age.      Observational Objectives:        -  To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine,          administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in          children 6 months to < 9 years of age.        -  To submit remaining available sera from subjects to the Center for Biologics Evaluation          and Research (CBER) for further analysis by the World Health Organization (WHO), the          Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration          (FDA) to support selection and recommendation of strains for subsequent years' influenza          vaccines.   "
121826|NCT01691313|"     Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in     a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or     flutter of recent onset to normal sinus rhythm.   "
121827|NCT01691300|"     Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT     PET/CT) may help detect lesions before treatment and evaluate response following therapy in     patients with from multiple myeloma (MM). This study aimed to prospectively assess the     clinical utility of ACT PET/CT in MM as compared to the commonly used     F18-fluorodeoxyglucose(FDG).   "
121848|NCT01691027|"     The research is aimed at developing and testing a new method of visual-motor rehabilitation     of Veterans with macular degeneration by using inexpensive tablet computers at home.   "
121828|NCT01691287|"     Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal     checks of blood sugar levels, injecting insulin, changing eating habits and physical     exercise, which requires a real change in the life of the child & adolescent and can cause     significant damage to the quality of life as well.      Compliance to treatment is a major challenge for all patients and mostly to adolescence,     which often worsen their diabetes control at that age.      The Michael Method is a unique, holistic program to develop and realize an individual's     emotional, intellectual and behavioral potential, which is based on the belief that every     human being can excel in every field they choose. The method was developed in 1988 by a     multi-disciplinary team of professional academic in Israel. Today the Israeli education     system implements the method in Junior High Schools and High Schools in diverse educational     sectors. The program is taught at many other various frameworks: teachers' continuing     education programs, colleges, programs run by the Ministries of Defense and Social Welfare,     the National Insurance Institute, the National Electric Corporation and in many other public     and private frameworks.      The proposed study is aimed to assess whether the Michael Method can be used as a tool for     improving metabolic control and quality of life among uncontrolled adolescence with type 1     diabetes   "
121829|NCT01691274|"     The purpose of this study in healthy people is to investigate safety, toleration and time     course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The     preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162     will also be investigated.   "
121830|NCT01691261|"     Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related     macular degeneration in whom there is rapidly progressing vision loss   "
121831|NCT01691248|"     The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus     placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult     participants undergoing hematopoietic stem cell transplantation (HSCT). The primary     hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants     undergoing HSCT.   "
121832|NCT01691235|"     Subjects are being asked to participate in this study because they have genotype 1 Hepatitis     C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin,     and telaprevir as part of their routine care. The purpose of this study is to see if the     SIMpill automated pill dispensing device can help subjects take their medications at the     times the doctor has instructed them to take it.      The SIMpill device is an automated pill dispensing device that records a time stamp each time     the device is opened and a dose of medication is taken. Physicians can download this data and     generate a precise account of when you have taken your medication. In addition, if a dose is     missed, the SIMpill device can be set to automatically notify you by text message if a dose     is overdue. The Simpill device is a new way to keep track of when you take your HCV     medications and will also help remind you when you forget to take a dose. In addition, this     information will help your doctors understand how taking medication on time effects the     success of the therapy.   "
121833|NCT01691222|"     Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible     fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the     patients. This situation may lead to many disadvantages for ventilation and airway protection     of critically ill patients during the procedures. The use of double lumen endotracheal tube     dedicated to the percutaneous tracheostomies may:        1. improve the ventilation of patients during the procedure,        2. protect the posterior tracheal wall from damage related to the different step of          tracheostomies,        3. protect the lungs from blood and secretions coming down from the chosen site of          tracheostomy.      So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and     complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen     endotracheal tube.   "
121834|NCT01691209|"     The study shall explore whether treatment of atopic dermatitis is equally effective with     Phoenix medical device as compared to standard therapy (Hydrocortisone cream).   "
121835|NCT01691196|"     Our study addresses the following research question: What is the role of obesity in     modulating inflammation and innate immune function, as well as the overall responsiveness of     innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in     patients undergoing peritoneal dialysis?      The investigators hypothesize that obesity will lead to increased inflammation in patients     undergoing peritoneal dialysis.   "
121836|NCT01691183|"     The purpose of this research study is to learn about the variability in proptosis     measurements. Measurements will be recorded using the Hertel exophthalmometer. This     noninvasive tool is an instrument designed to measure the forward protrusion of the eye and     may be used normally during a general eye exam. This instrument provides a method of     evaluating and recording the progression and regression of the prominence of an eye caused by     disorders such as thyroid disease and tumors of the orbit.   "
121837|NCT01691170|"     The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior     aspect of the knee, although peripatellar pain and / or retropatellar are also common. In     general, conservative treatment is the initial option of choice for patients with PFPS,     however, the lack of a specific causal factor makes it difficult to choose the best treatment     so early. This way, the purpose of this study is investigate the effects of the quadriceps     femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.   "
121838|NCT01691157|"     The purpose of this trial is to investigate the effectiveness of an evidence based exercise     program for shoulder impingement. Approximately 1% of adults consult their General     Practitioner (GP) with shoulder pain each year, making it the third most common reason for     musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed     with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly     referred for physiotherapy treatment. This trial aims to compare the effectiveness of an     evidence based exercise protocol with usual physiotherapy care.   "
121849|NCT01691014|"     The rationale for this study is to further explore if development of antibodies against TNF-α     blocking agents is associated with reduced clinical effect/worsened clinical outcome. An     important aspect of the study is to carry out an exploratory analysis of the immunogenicity     of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using the same     cell-based assay.   "
121839|NCT01691144|"     Follow-up of cancer patients accounts for a substantial part of outpatient activity, and     alternative models of care are developing. In some countries, low-risk follow-up is already     done in primary care, mainly in breast, and colorectal cancer. In this study the     investigators will explore gynecological cancer patients about their expectations regarding     their future follow-up plan. Further, the investigators will ask about the experience and     satisfaction among patients who have already attended a follow-up programme for 2-3 years. In     addition, the investigators will especially focus on the cooperation aspect between primary     and secondary care. The investigators hypothesize that follow-up of selected gynecological     cancer patients can be done by general practitioners.   "
121840|NCT01691131|"     Introduction: There is evidence that demonstrate the beneficial effects of pulmonary     rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of     life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the     studies used high intensity endurance and strength exercise training on land. Exercise on     water is an effective form of training that has been used for decades for rehabilitation in     different chronic conditions. In addition, there are promising preliminary results on the     literature regarding aquatic training in patients with COPD. However, several gaps remain.      Aim: Compare the effects of two rehabilitation programs with 6 months of duration in patients     with COPD on physical activity in daily life and balance: land versus water.      Methods: The sample will consist of 60 patients with COPD diagnosed according to the GOLD     criteria, 50 years old or more and clinically stable.      Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months     after the end of the PR (follow up). In addition to the assessment of physical activity in     daily life and balance, the investigators will also evaluate pulmonary function, peripheral     and respiratory muscle strength, body composition, maximal and submaximal exercise capacity,     functional status and quality of life.      Both groups (land or water) will be submitted for 3 sessions of exercise training per week,     with 45 minutes of duration, during 6 months. The sessions of both groups include the same     exercises sequence. Endurance exercise training will be performed on a bicycle and walking on     land and strength training using free weights. Workload will be established according to the     tests performance on assessment and progression will follow a predetermined schedule and     adjusted according symptoms. On water the same approach will be followed.      Expected results: the investigators expect improvement in terms of symptoms, exercise     capacity, muscle strength, quality of life, functional status and physical activity in daily     life at the end of the two training protocols. However, it is unclear whether one training     protocol will be superior than the other. Due to the characteristics involved in the aquatic     training, the investigators hypothesized that this type of training can result in better     results on balance.   "
121841|NCT01691118|"     Approximately half of hypertensive patients have diastolic dysfunction and diastolic     dysfunction is associated with development of congestive heart failure and increased     mortality. Although diastolic heart failure associated with hypertension is a clinically     significant problem, few clinical trials have been conducted and there is no proven     pharmacological therapy to improve outcomes. To the best of the investigators knowledge,     there has been no randomized trial to demonstrate that an antihypertensive drug improves     diastolic function in hypertensive patients with diastolic dysfunction. The investigators     hypothesize that fimasartan added to standard therapy will be superior to placebo in     improving diastolic dysfunction in mildly symptomatic patients with hypertension and     diastolic dysfunction, and try to examine this hypothesis in a double-blind, randomized     comparison study using echocardiography.   "
121842|NCT01691105|"     This study will implement and test the effectiveness and cost-effectiveness of a tobacco     cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for     adults admitted to the hospital. The intervention will begin during the hospital stay and     continue after discharge. The intervention will use resources easily available to most acute     care hospitals: computerized physician order entry, physician and nurse education, staff     meetings for physicians, nurses and allied health professionals, online learning     capabilities, faxing to primary care providers (PCPs), and the telephone counseling and     support available from a state smokers' quitline (QL).      The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be     more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in     the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report     and biochemical verification (exhaled carbon monoxide reading).   "
121843|NCT01691092|"     This study is designed to look at that involvement of a process in the brain called the     glutamate system in depression. Participants will undergo a screening session, up to two     functional Magnetic Resonance Imaging (fMRI) scans, and up to three Positron Emission     Tomography (PET) scans, as well as cognitive testing at each scan session. For one of the PET     scans, a drug (either ketamine or n-acetyl cysteine) will be administered.      Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine     (NAC) will lead to a decrease in mGluR5.      Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills     after drug challenge.      Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in     MRI measures post drug challenge as compared to baseline, signifying synaptogenesis.      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5     availability due to differences in ABP688 radiotracer infusion.   "
121844|NCT01691079|"     This will be a double-blind placebo-controlled study in which we plan to study 40 competitive     endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2     exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes     will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the     athletes' airway response to the exercise challenge with and without the active drug.   "
121845|NCT01691066|"     The purpose of this study aims to investigate the utility of Pivotal Response Treatment     (PRT), a behaviorally derived intervention, to improve the quality and frequency of     communication and social engagement of toddlers with siblings who have an autism spectrum     disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social     interaction between 12 and 15 months of age.   "
121846|NCT01691053|"     End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality.     Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left     ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent     predictor of survival. Yet, to date there is no established medical treatment to reduce CV     morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by     means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves     outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been     shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The     investigators here hypothesize that spironolactone treatment is cardioprotective by reducing     LVM in ESRD patients on dialysis.   "
122418|NCT01683721|"     The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System     in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).   "
121850|NCT01691001|"     Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a     frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent     selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and     anaesthetics that must be concomitantly administered. This study was conducted to assess the     effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA     in children undergoing ambulatory surgery.   "
121851|NCT01690988|"     Delirium is a medical term or condition that includes a temporary inability to focus     attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than     60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug     called ketamine can decrease the chance that patients will experience delirium after their     surgery. The investigators are also testing whether ketamine decreases postoperative pain,     postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length     of stay, and adverse outcomes (e.g. hallucinations and nightmares).   "
121852|NCT01690975|"     This is a single-center, randomized, third party blind, placebo controlled, dose escalation     study of benzonatate following single dose administration. The primary oobjective is to     assess the safety and tolerability of increasing oral doses of benzonatate following single     dose administration in healthy male and female subjects.   "
121853|NCT01690962|"     The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a     low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and     other subjective symptoms, more effectively than a vitamin B12 supplement with no diet     changes. The principal measure is pain as measured by the following assessment tools:     Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy     Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill     Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks.      This study also examines the effects of a low-fat, vegan diet on mood, using the Center for     Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.   "
121854|NCT01690949|"     This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced     airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal     volunteers.   "
121855|NCT01690936|"     Identifying snacks that do not contribute to positive energy balance is crucial in weight     management. The satiating effects of almonds, coupled with their convenience and palatability     make them a promising weight management aid. Therefore, this study aimed to examine the     effects of almond consumption with meals versus snacks on outcomes such as appetite, energy     intake, body weight, as well as blood glucose, insulin and lipid responses.   "
121856|NCT01690923|"     The aim of this evaluation is to test:        1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks        2. Patient mask type preferences at high pressures   "
121857|NCT01690910|"     This is a 10-week pilot study for a randomized non-blinded controlled clinical trial to     assess whether use of the Rifton Gait Trainer will improve the incidence of mobilization of     critically ill ventilator dependent patients in the intensive care units (ICUs) and improve     important patient outcomes. The pilot study is designed to assess the feasibility and     logistics of doing a study of this nature in the ICU; it will also provide the means to     obtain estimates of outcome effect sizes, number of repeated measures, time between repeated     measures, and intra-subject and intra-unit correlations, to be used for sample size     calculations.   "
121858|NCT01690897|"     The purpose of this study is to test and determine the efficacy of an 8-session     mindfulness-based psychoeducational intervention for women with sexual interest/ desire     concerns when compared to a wait-list control condition.   "
121859|NCT01690884|"     The investigators are trying to determine if a single dose of Ticagrelor will increase     delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with     adenosine reuptake blockade.   "
121860|NCT01690871|"     Study objectives:      The primary objective is to determine the efficacy of BEZ235 on Objective Response Rate (best     response on study) according to RECIST 1.1 criteria      The secondary objectives are:        -  To determine the progression free survival rate at 32 weeks in the included population        -  To assess the duration of response among responders        -  To evaluate time to response        -  To evaluate the time to progression        -  To assess the overall survival        -  To evaluate safety and tolerability of BEZ235      The exploratory objectives are:        -  To identify molecular and genomic profiles of PEComas and their potential relationship          to clinical outcome by analyzing PIK3CA, Ras, Raf, TSC, AKT and PTEN alteration in tumor          samples (archival or fresh pre-treatment tumor biopsy) and PIK3CA in circulating DNA.        -  To determine biomarkers relevant to BEZ235 activity by analyzing the expression of          phosphoproteins p-AKT, p-S6, p-4EBP1 at screening and during treatment as well as          biomarkers for the proliferation (Ki-67) and apoptosis (PARP) (only if fresh tissue          (optional) is available).      Study population:      The patient population consists of patients 18 years old or older with progressive     unresectable/advanced or metastatic malignant PEComas previously treated for     unresectable/advanced/metastatic disease with 1 to 2 prior lines of chemotherapy. Patients     must have adequate hematologic, renal, cardiac and hepatic functions and not be previously     treated with a mTOR inhibitor.      Number of patients:      16 to 33 patients      Overview of study design:      This is a prospective, multicenter, open-label, single arm, two-stage phase II study to     investigate the efficacy and tolerability of BEZ235 in patients with progressive metastatic     or unresectable/advanced malignant PEComas. The patient should have received 1 or 2 prior     lines of chemotherapy.      BEZ235 will be administered until disease progression. Sixteen patients will be enrolled into     Stage 1 and observed for at least 32 weeks at which time an interim analysis will be     performed (plus eventually 4-5 weeks for confirmation of responses occurring on or closely     before this cut-off date). If the number of patients with a response (CR or PR) is 2 or less,     the trial will be stopped for futility. If 3 or more patients experience a response     enrollment will continue up to 33 patients (Stage 2).      An Independent Data Monitoring Committee (IDMC) will be constituted for reviewing the interim     analysis.   "
121861|NCT01690858|"     The aim of the study is to assess the role of complement dysregulation and its impact on     antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.   "
121884|NCT01690559|"     This study is a post-marketing surveillance in Japan to investigate the safety especially     focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv     administration without dilution in the daily practice.It is a local prospective and     observational study of patients who have received Ciproxan intravenously for sepsis,     secondary skin infections followed by superficial burn, post-surgical or post-traumatic,     pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to     be enrolled and assessed during the period of treatment with Ciproxan.   "
121885|NCT01690546|"     The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment     to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol).     The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding     the treatment acceptable and showing minimal withdrawal discomfort.   "
121862|NCT01690845|"     Hypoxic hepatitis (HH) is reported to be the most frequent cause of elevated aminotransferase     levels in hospital. Up to 10 % of critically ill patients develop HH during the course of     their intensive care unit (ICU) stay. Occurrence of HH is a life threatening event and     ICU-mortality is reported to be up to 60%. Early therapeutic intervention is of central     prognostic importance in patients with HH to improve the hemodynamic impairment as early as     possible, to reduce hyperammonemia and hepatic encephalopathy, to avoid progression of organ     failure and to improve outcome. Studies reported that Molecular Adsorbent Recirculating     System (MARS®) therapy improved the hemodynamic situation in patients with acute and acute on     chronic liver failure. The study hypothesis is that MARS® therapy in critically ill patients     with severe HH improves hepatic hemodynamics and function and consecutively the course of the     disease. 40 patients with suffering of severe HH with aminotransferase levels > 40 times the     upper limit of normal of more than 12 hours will be randomized 1:1 to MARS® therapy (n=20) or     conventional therapy (n=20). 4 MARS®-sessions will be performed on three consecutive days,     each for at least 12 hours. Treatment will be continued under special circumstances. The     maximum duration of the treatment phase is 7 days. The primary endpoint is the difference of     the indocyanine plasma disappearance rate at day 7. The expected duration of the study is 2     years.   "
121863|NCT01690832|"     Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury     (AKI) when they undergo urgent/emergency coronary angiography.      The optimal medical treatment for preventing the occurrence of contrast induced - acute     kidney injury is still controversial.      Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that     has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary     studies.      Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI     already shown to be useful for earlier diagnosis of contrast induced nephropathy.      The primary objective of this study is to to test the hypothesis that fenoldopam, in addition     to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in     patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography     and/or percutaneous coronary intervention.   "
121864|NCT01690819|"     Acute respiratory distress syndrome (ARDS) occurs in almost 20% of patients with severe acute     brain injury and is associated with increased morbidity and mortality. A massive increase in     sympathetic activity and an increased production of proinflammatory cytokines released into     the systemic circulation are the most important recognized mechanisms. Altered blood brain     barrier after injury causes spillover of inflammatory mediators from the brain into the     systemic circulation leading to peripheral organs damage. The adrenergic surge induces an     increase in vascular hydrostatic pressure and lung capillary permeability, causing an     alteration of alveolar capillary barrier with fluid accumulation, resulting in ARDS.      The main goal of mechanical ventilation after acute brain injury are the maintenance of     optimal oxygenation, and a tight control of carbon dioxide tension, although ventilatory     settings to be used to obtain these targets, while avoiding secondary insults to the brain,     are not clearly identified.      Protective ventilatory strategy has been positively evaluated first in patients with ARDS,     and then in those undergoing cardiopulmonary bypass or lung resection surgery, or in brain     death organ donors, but data on the effect of protective mechanical ventilation on patients     with acute brain injury are still lacking even if this is a population with recognized risk     factors for ARDS.      Therefore, the primary aim of this multi-center, prospective, randomized, controlled trial is     to investigate whether a protective ventilatory strategy, in the early phase after severe     acute brain injury, is associated with a lower incidence of ARDS, avoiding any further damage     to the brain. Secondary aim is to evaluate if a protective ventilatory strategy is associated     with reduced duration of mechanical ventilation, incidence of organ failure, intensive care     unit length of stay, and lower concentrations of plasma inflammatory cytokines, without     adversely affect in neurological outcome.   "
121865|NCT01690806|"     Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important     complications of thyroid surgery. The duration of convalescence, after non complicated     thyroid operation, may depend on several factors of which pain and fatigue are the most     important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well     known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The     investigators therefore undertook the present study to investigate whether preoperative     dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.   "
121866|NCT01690793|"     The investigators hypothesize that there is a statistically significant decrease of     Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels     following treatment of an exacerbation of asthma.   "
121867|NCT01690780|"     Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or     ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine     as needed for pain relief for the first 24 hours following discharge from the emergency     department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We     hypothesize that oral morphine will result in greater pain relief than ibuprofen.   "
121868|NCT01690767|"     Children 0-24 months of age requiring a urethral catheterization for urine collection will be     randomized to receive either topical and intraurethral 2% lidocaine or standard of care to     assess for the effectiveness of the former in minimizing pain during urethral     catheterization. It is hypothesized that administration of 2% lidocaine gel both topically     and intraurethrally will confer a greater degree of pain reduction compared to standard of     care.   "
121869|NCT01690754|"     In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating     the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive     Reminders is an interactive SMS reminder system to help patients remember to take their TB     medication. In this system, patients receive daily SMS reminders for the duration of their     treatment at a pre-specified time, reminding them to take their medication. Patients are     asked to reply back to the system, either through SMS or a missed call, with the time they     took their medicine that day. If a response is not received within two hours, a second     reminder is sent. If a response is still not received in a further two hours, a third and     final reminder for the day is sent. Non-responsive patients are followed up with phone calls     and a list of non-responsive patients is shared with clinics based on the parameters of     non-responsiveness that they specify.      IRD seeks to determine the impact of this system on treatment outcomes and compliance to     prescribed medication through administering a randomized control trial among newly diagnosed     TB patients in Karachi, Pakistan.   "
121870|NCT01690741|"     This study will be the first to test the anti-cancer peptide Nerofe in humans. It will     evaluate the safety, pharmacokinetic behavior, and pharmacodynamic and clinical effects of     Nerofe given intravenously every other day to patients with advanced malignant disease.   "
121940|NCT01689831|"     Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the     standard tuberculin purified derivative (PPD-S2).   "
121871|NCT01690728|"     The aim of this study is to increase our knowledge about the effect of physical activity in     patients who have undergone gastric bypass surgery. The study will provide novel information     in two areas. The main objective is to study the effect of physical activity on the weight     loss and cardiovascular risk factors. This will be accomplished in a randomized clinical     trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to     six month of structured physical activity or standard postoperative counseling. The study     will include an exhaustive panel of blood tests related to cardiovascular risk and the most     extensive evaluation of structural and functional vascular test done in this patient group so     far. In addition the study will provide information of the effect of bariatric surgery per se     since both pre- and postoperative investigations are conducted. The study will learn us to     what degree it is possible to motivate this group of patients to increased physical activity.     All together this will enable us to improve the counseling of the patients undergoing GB.   "
121872|NCT01690715|"     A retrospective study based on analysis of medical records of patients with hepatocellular     carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with     diagnosis confirmed by imaging or histological specimen underwent surgical resection with     curative intent. The study aims to determine the prognostic value of vascular complications     related to cancer and to evaluate the survival rate of these patients, comparing the data     with those reported in the literature.   "
121873|NCT01690702|"     two-armed trial to compare E-nP-C against tailored dtEC-dtD in patients with high risk early     breast cancer   "
121874|NCT01690689|"     The purpose is to assess the safety profile and performance of a femoral resurfacing implant     for localized chondral lesions.   "
121875|NCT01690676|"     Effect of apple polyphenols on FMD.   "
121876|NCT01690663|"     When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory     and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic     shoulder surgery. This study seeks to determine if there is a relationship between the     duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP)     when combined with increasing doses of dexamethasone.   "
121877|NCT01690650|"     -  Due to the increased risk of brain damage, continuous monitoring of the cerebral          oxygenation is interesting. The investigators will evaluate the capability of the INVOS          Oximeter to detect induced changes in the cerebral regional saturation.        -  The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction          after oxygen exposure is prolonged in preterm infants compared to term infants.   "
121878|NCT01690637|"     This is a prospective, randomized, double-blind, placebo-controlled trial that will be     conducted in tertiary care pediatric hospitals in El Salvador and Panama. The primary purpose     of this study is to determine whether empiric oseltamivir phosphate treatment given at the     time of hospital admission to children less than 10 years of age hospitalized with influenza     can effectively reduce their illness severity. Additional objectives are to: 1) evaluate the     tolerability of oseltamivir phosphate treatment, 2) evaluate the effect of oseltamivir     treatment on viral clearance and development of oseltamivir-resistant influenza virus during     and after treatment in children hospitalized with influenza, 3) estimate the direct and     indirect costs of all-cause respiratory illness and influenza-associated respiratory illness     requiring hospitalization, and 4) evaluate the effect of empiric oseltamivir treatment during     the influenza season on these costs.      The primary study hypothesis is that children with laboratory-confirmed influenza receiving     empiric oseltamivir phosphate treatment initiated at the time of hospital admission will have     a shorter duration of hospitalization and a shorter time to resolution of signs of severe     respiratory illness compared to children receiving placebo. The secondary study hypotheses     are that children with laboratory-confirmed influenza receiving oseltamivir phosphate     treatment will have a reduction in the time to non-detectable influenza virus and influenza     viral RNA and children with all-cause respiratory illness receiving oseltamivir phosphate     will not be more likely to experience severe adverse events than children receiving placebo.   "
121879|NCT01690624|"     Patients with acute myeloid leukemia who experience a relapse after at least one prior     regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are     in complete remission with high risk to relapse may be eligible for this trial. The trial     will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose     levels.   "
121880|NCT01690611|"     The goal of this research is to determine if real time visual feedback of body movements     improves balance control more than walking on a treadmill alone. Individuals participating in     this research study will be tested using a battery of clinical strength and balance     assessments twice before a 4 week training period and once after the training period. The 4     week training period will consist of 12 sessions walking on a treadmill. The experimental     group will see real time visual feedback regarding their body movements, and the control     group will not receive this visual feedback. Following the 4 week training each participant     will again be tested using the battery of clinical strength and balance assessments.   "
121881|NCT01690598|"     The purpose of this study is to investigate the effect of combined topotecan and veliparib     (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown     BRCA mutation status.   "
121882|NCT01690585|"     The upper and lower gastrointestinal bleeding, not related to portal hypertension, is a     common disorder in the elderly. Indeed, in 1996, in a French study, the median age of     patients hospitalized for upper gastrointestinal bleeding was 68. During the same period in     the studies reported in English the median age was 71. If epidemiological data concerning     lower gastrointestinal bleeding are rare, the average age of hospitalized patients varies     from 63 to 77 depending on the study. Due to improvement in endoscopic haemostatic procedures     and current resuscitation methods, gastrointestinal bleeding prognosis has greatly improved,     whereas anaemia related to a bleeding episode remains a frequent complication of     gastrointestinal bleeding in elderly patients.      Among elderly patients over 65, the prevalence of anaemia varies from 8 to 44% depending on     the criteria used and populations studied. The occurrence of a bleeding episode can either     induce anaemia or exacerbate pre-existing anaemia. Physicians in charge of gastrointestinal     bleeding are often unaware of anaemic consequences in the elderly patients which can often be     serious. Various studies have shown that anaemia increases morbidity and mortality rates in     the elderly. Life expectancy is independently significantly lower for anaemic patients over     65, than for non-anaemic subjects. Anaemia is also a risk factor for the occurrence of     cardiovascular and neurological complications, impairment in cognitive function and increased     risk of falling.      Iron deficiency and anaemia induced by bleeding episodes in patients over 65 hospitalized for     upper or lower gastrointestinal bleeding should be corrected rapidly and effectively.     Currently, the cost and risks of infection or cardiovascular-related complications of     transfusions lead to limiting red blood cell transfusion with a goal average of 9 g/dL     haemoglobin. It is also necessary to develop alternatives to massive transfusions. The     correction of iron deficiency promotes erythropoiesis and can quickly correct anaemia.      In clinical practice, the effectiveness of iron intake by the oral route is limited by the     frequent occurrence of significant gastrointestinal side effects that limit patient     compliance and limited absorption necessitating prolonged treatment to correct iron     deficiency.      The black colour of stools caused by taking oral iron supplements also makes it difficult to     detect a possible recurrence of bleeding after hospitalization.      The prescription of intravenous iron seems more suitable for a rapid and complete correction     of iron deficiency after gastrointestinal bleeding. The main objective of our study is to     evaluate efficacy of intravenous iron for the correction of anaemia, measured by haemoglobin     at week 6 (W6) in patients aged over 65, after gastrointestinal bleeding. Secondary     objectives were to assess the speed of anaemia correction, the tolerance of intravenous iron     supplementation, the rate of re-hospitalization within 6 months after discharge and patients     quality of life. This is a prospective multicenter randomized study versus placebo. After     obtaining informed consent, all patients aged over 65 admitted with upper or lower     gastrointestinal bleeding, with successful outcome, not related to portal hypertension,     responsible for persistent anaemia (definition: Hb < 11 g / dL) after hospitalization will be     included in the study. Patients will be treated for their bleeding event in the usual manner     of each centre with target for transfusion of 9 g / dL haemoglobin. The absence of external     bleeding and haematocrit and/or constant haemoglobin levels will be considered as the end of     bleeding.      Day 1 was arbitrarily defined as the day the patient left hospital. The protocol at Day - 1     included: obtaining informed consent of the patient, determination of iron and ferritin blood     levels and complete blood count. and randomization intravenous iron injection , (Ferinject)     versus Placebo. Intravenous iron injection will be performed at Day 0. A complete blood count     will be performed at week 6 and month 6. Patients will be reviewed in consultation at week 6     and at month 6 to obtain related intercurrent events and assess their quality of life.      The results of this study could lead to changes in the care of older patients hospitalized     for gastrointestinal bleeding.   "
121883|NCT01690572|"     Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in     diffuse small vessel disease especially of diabetic patients. High restenosis rates after     balloon only procedures in small vessels occur due to negative constrictive vessel remodeling     if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not     indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral     arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT     FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after     dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA)     using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive     remodelling process will be measured by optical coherence tomography (OCT) at 9 months median     F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.   "
121886|NCT01690533|"     The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg     (hereinafter as Avelox) in treating secondary infection of chronic respiratory disease.It     is a local prospective and observational study of patients who have received Avelox tablets     for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in     chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and     assessed during the period of treatment with Avelox.   "
121887|NCT01690520|"     This randomized phase II trial studies how well donor umbilical cord blood transplant with or     without ex-vivo expanded cord blood progenitor cells works in treating patients with acute     myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or     myelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donor     umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the     patient's immune system from rejecting the donor's cells. When the healthy stem cells and     ex-vivo expanded cord blood progenitor cells are infused into the patient they may help the     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It     is not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expanded     cord blood progenitor cells is more effective than giving a donor umbilical cord blood     transplant alone.   "
121888|NCT01690507|"     Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the     expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory     molecules and adhesion molecules. The leukemias cells treated by decitabine will become more     sensitive to the following adoptive T cell therapy.   "
121889|NCT01690494|"     This study is a randomized controlled trial (RCT) that will rigorously evaluate the     implementation, effectiveness and cost-effectiveness of a couple-based integrated human     immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with     drug-involved male offenders charged with misdemeanors and their primary female sexual     partners, implemented by frontline providers in Criminal Court, Community Court or probation     (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary     outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.   "
121890|NCT01690481|"     Simplified Brochure      Neuropsychological Testing/Assessment is like games for the child. They are asked to complete     the sequence, identify pictures, explain what is happening, etc. There is no personality     testing involved. Part of the standard IQ testing is done but no IQ score is obtained. Age     appropriate testing is done for each child.      The MRI is an enclosed machine. We have the child sit in a simulator after the     neuropsychological testing to see what it will be like, including the sounds, etc. You will     be given a video about MRI testing to view as well. The staff that does this has been doing     this for years in a wide variety of children, young, developmental delayed, etc. The staff     does this WITHOUT sedation. Some children cannot sit still through the entire series. We need     to get six, 10 minute scans. Children are allowed movement such as the need to wiggle their     toes and move in between each scan.      The Neuropsychological Testing can be scheduled in the late afternoons if it is more     convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled     after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked to     repeat the Neuropsychological Testing and MRI scanning 24 months later.   "
121891|NCT01690468|"     The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe     and tolerable when given together, and to determine if this combination of drugs can help     people with recurrent ovarian cancer.   "
121892|NCT01690455|"     This observational, multi-center study will evaluate the efficacy and safety of Mircera     (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in     daily clinical practice. Patient will receive Mircera according to local summary of product     characteristics. Data will be collected for 12 months.   "
121893|NCT01690442|"     The proposed study addresses a significant public health threat of HIV, HCV and other STIs     among a very high risk population of active IDUs and their sexual partners in Kazakhstan a     region that is experiencing one of the fastest rising HIV epidemics in the world. There is a     race to develop and implement effective HIV preventive interventions for IDUs and their     sexual partners to stem the spread of HIV, HCV and other STIs in Almaty, Shu and other     Central Asian towns along drug trafficking routes. The proposed study will test the     effectiveness of a couplesbased HIV/STI risk reduction intervention to decrease new cases of     HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well as     to reduce unsafe injection practices and increase condom use among injecting drug users     (IDUs) and their heterosexual, intimate partners in Kazakhstan.   "
121894|NCT01690429|"     Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA)     from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude     decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is     a surrogate marker for waking reactions (arousal) which eventually will contribute to assess     sleep disruption and resulting performance deterioration. Arousal and performance     deterioration and its possible improvement under continuous positive airway pressure (CPAP)     therapy will be determined in this study.   "
121895|NCT01690416|"     The aim of the project is to compare two methods for arterial cannulation. The traditional     method with ultrasound guided cannulation. The investigators goal is to improve this     procedure to reduce pain and complications.   "
121896|NCT01690403|"     Primary Objective:      - To evaluate the effect of single and repeated administration of rifapentine given as daily     or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and     tenofovir given as a fixed dose combination (ATRIPLA™ ).      Secondary Objective:      - To evaluate the safety and tolerability of concomitant administration of rifapentine and     ATRIPLA™ given to HIV+ patients   "
121897|NCT01690390|"     The primary purposes of this study are to assess the safety and efficacy of using high doses     of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer     that achieve stable disease after 8 weeks routine therapy.   "
122017|NCT01688830|"     The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI     655075 following intravenous administration of single rising doses of BI 655075 when     administered alone and after administration of dabigatran.   "
121898|NCT01690377|"     Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As     such they are currently used in clinical vaccination protocols in cancer patients, and both     immunological and clinical responses have been observed. Several subsets of dendritic cells     have been characterized in the peripheral blood. One such subset is referred to as     plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC     and myDC have not been evaluated for their capability to induce anti-tumor immune responses     in patients. For this reason the investigators will perform a safety and efficacy study with     PDC and myDC in stage IV melanoma patients.   "
121899|NCT01690364|"     Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce     neural damage during neurosurgery.      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial     NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is     preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in     clinical use. But there have been no reports about the effect of changing NMB agent on     efficacy of MEP monitoring.      Therefore, the investigators performed a randomized controlled trial to evaluate the effect     of changing NMB agent on the variability of MEP amplitude during neurosurgery.   "
121900|NCT01690351|"     The primary purpose of this study is to estimate the relative bioavailability and food effect     of a PF-05089771 capsule.   "
121901|NCT01690338|"     The purpose of this study is to determine the incidence of residual curarization in PACU and     relevant risk factors.   "
121902|NCT01690325|"     The GALADON trial is a diagnostic and interventional study in which different molecular     imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance     Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods     (mammography, ultrasound) to see if there can detect an early response to a combined     neoadjuvant therapy with bevacizumab and docetaxel in patients with locally advanced breast     cancer. Neoadjuvant chemotherapy (this means patients were treated before the tumor was     removed by surgery) with a drug like trastuzumab (monoclonal antibody) which is target to the     Her2-protein is much more powerful than with chemotherapy alone because it is normalizing the     blood supply and improves tumor delivery of conventional chemotherapy like docetaxel. The     HER2 protein is only available in about 30 % of breast cancer types. bevacizumab is another     humanized monoclonal antibody like trastuzumab but is effective not only in patients with an     positive HER2 status and in combination with trastuzumab it may emphasize the effect in     reduction of tumor growth. Bevacizumab is approved in advanced disease, but no major     neoadjuvant data available so far for primary breast cancer. As the therapy with monoclonal     antibody regimes are expensive and may cause severe side effects predictive factors to select     patients who will benefit from such highly specific drugs before therapy start would be     medically and economically highly valuable. In this study the efficacy of combined     neoadjuvant chemotherapy with bevacizumab, trastuzumab and docetaxel in Arm A and bevacizumab     and docetaxel in Arm B should be evaluated and the predictive impact of different imaging     methods for tumor response should be shown.   "
121903|NCT01690312|"     The objective of this study is to determine the acute and chronic [4-week] effects of a     high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of     cardiovascular disease risk, in adults on Statin therapy.   "
121904|NCT01690299|"     This study will test the clinical effectiveness and safety of apremilast compared with     placebo as well as etanercept compared with placebo in the same group of patients with     moderate to severe plaque psoriasis.   "
121905|NCT01690286|"     The purpose of this study is to evaluate the effects of repeated twice-daily administration     of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.   "
121906|NCT01690273|"     Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore     axial mobility, but there are no data regarding a specific rehabilitation program that     includes flexibility alone and its association with resistance exercises in AS patients with     stable disease activity. So, we assessed the effects of two exercise programs in terms of     mobility, functional capacity, quality of life and disease activity in AS patients. Methods.     Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI)     <4 were included.   "
121907|NCT01690260|"     Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional     ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local     application of BMP results in an increase of osseous tissue regardless of the location of the     growth factor.      5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and     improve clinical results when autologous bone graft is reduced or removed.      The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace     autologous bone graft in order to stimulating ossification during transplantation of osseous     tissue.   "
121908|NCT01690247|"     Liver transplantation is the only lifesaving intervention for patients with end-stage liver     diseases. Despite the ability of current immunosuppressive agents to reduce the incidence of     acute rejection, the rate of acute rejection reaches to 20-50% after liver transplantation.     Furthermore, the long-term toxicity associated with current regimens for liver transplant     recipients now is increasingly being perceived as an unmet clinical need. Mesenchymal stem     cells (MSC) appeared to be effective in regulating the invoked immune response in setting     such as tissue injury, transplantation, and autoimmunity, and have been used successfully to     treat graft versus host disease and show immune modulation function both in vitro and in vivo     and may help in repairing damaged tissue(s). Here, we evaluate umbilical cord derived MSC     (UC-MSC) as an alternative immunosuppressive agents for liver transplanted patients, and     examine if UC-MSC could improve the recovery of liver function.   "
122018|NCT01688817|"     The purpose of this study is to assess the impact of physician's counseling on participation     and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening     program   "
122019|NCT01688804|"     Greater time spent in sedentary behaviors, independent of physical activity level, can     increase risk of morbidity and mortality. Objective assessments indicate that bariatric     surgery patients spend large amounts of time in sedentary behaviors. The present study is the     first to test whether a mobile health (mHealth) approach that employs widely adopted     smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible     and acceptable method of reducing sedentary time in these patients and other obese     populations.   "
121909|NCT01690234|"     In Denmark the number of patients, sick listed for more than four weeks is increasing, and     patients suffering from musculoskeletal disorders make one third of the total amount of     long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal     diseases, including low back pain, are less likely to return to work after a period of sick     leave. It seems that a multidisciplinary intervention, including cooperation between the     health sector, the social sector and in the work place, has a positive effect on days off     work due to musculoskeletal disorders and particularly low back pain. The aim of this study     is to evaluate the effect of a work oriented multidisciplinary intervention.      A randomized controlled trial will include 770 patients with low back pain. The study     population consists of patients, who are sick listed or at risk of sick leave due to LBP.      The control group is treated with usual care in a team with participation of a     physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The     Intervention group is treated with usual care and in addition intervention of a psychologist,     an occupational physician, an ergonomist and a social worker from the local sickness benefit     office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at     the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of     days of work. Secondary outcomes are disability, pain, and quality of life.      This large RCT study is testing the effectiveness of a preventive intervention targeting     patients on short term sick leave or at risk being sick listed because of low back pain. We     have developed a novel multidisciplinary team structure using the treating physiotherapist as     the return to work coordinator, and having the case manager from the sickness benefit office     participating in team meetings.   "
121910|NCT01690221|"     The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride     cream) is safe and to see if it will help with treatment of pain associated with anal     fissures.   "
121911|NCT01690208|"     This is a pilot translational study aiming to compare the effects of a multi-component care     program with personalized drug regimen augmented by behavioural therapy with psychological     support and peer influence, led by a diabetes specialist team on metabolic control,     psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus     usual care.      The study hypothesis is to evaluate a novel individualized, multicomponent care program to     optimize glycemic control in difficult-to-treat type 2 diabetic patients.   "
121912|NCT01690195|"     This is a long term extension study to evaluate safety and tolerability of subjects who     complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate     Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.   "
121913|NCT01690182|"     The GI MRI Research group at the University of Nottingham has been developing new,     non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.     In collaboration with food manufacturer Unilever, the investigators want to image the abdomen     of healthy volunteers after consumption of test meals of varying volume and energy density to     determine levels of gastric distension and investigate possible correlations of this with the     subjects' sense of satiety.   "
121914|NCT01690169|"     This trial is conducted in Europe. The aim of the trial is to investigate safety,     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single     doses of NNC0113-0987 in healthy male subjects.   "
121915|NCT01690156|"     Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This is     usually done in the same plane as the ultrasound beam in America and is known as an in-plane     technique. When done correctly, the entire needle is visualized on the ultrasound screen as     it approaches the nerves which are also seen on the same screen the entire time. The     ultrasound probe can be held perpendicular or parallel to the shoulders of the person     performing the in-plane technique. Our hypothesis is that holding the ultrasound probe     perpendicular to the shoulder is superior to holding the probe parallel to the shoulder     during an in-plane ultrasound guided regional anesthesia technique.   "
121916|NCT01690143|"     This study is for patients that have multiple myeloma that has come back or relapsed and     their condition indicates a procedure called an Autologous Hematopoietic Stem Cell     Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are     removed before high-dose chemotherapy. Afterwards, the removed stem cells are put back into     the patient's body to form a new population of blood cells.      The high-dose chemotherapy administered before the AHSCT is called Conditioning Therapy.     The FDA has approved the use of the drug melphalan as a conditioning therapy. This research     study will look at whether adding the study drug called carfilzomib will improve participant     outcomes. Carfilzomib is considered investigational and is not approved by the FDA for the     treatment of relapsed multiple myeloma.      This study is divided into two phases.      Phase I: Dose Escalation Phase:      The main purpose of Part I of this study is to examine the safety of the study drug,     carfilzomib, and determine the safest amount of the study drug that can be given to subjects     who have multiple myeloma. Subjects on this study will receive different dose levels of the     study drug. If you are one of the first three subjects to receive the study drug, it will be     at what is called the 'starting dose' for the study which is the lowest dose that is expected     to be tolerated based on prior research. After the first set of participants receive the     study drug, the study doctor will review their health to see how they are tolerating the     treatment. This will decide if the study drug dosage will be increased or decreased for the     next set of subjects who join the study. It is anticipated that 12- 18 participants will     enroll in the Phase I portion of this study.      Phase II: Safety Confirmation Phase:      Once the study doctor has discovered the highest possible dose of study drug that subjects     can tolerate, up to 28 more subjects may be enrolled at that dose level. The main purpose of     the Phase II portion of the study is look at how effective the combination of carfilzomib and     melphalan when given before your stem cell transplantation is in treating multiple myeloma.     This expansion phase will also include evaluation of two single agent carfilzomib maintenance     therapy regimens for patients without disease progression at day 100.   "
121917|NCT01690130|"     The proposed study will measure the change of cortical excitability during nicotine craving     and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine     craving and cue-reactivity among adult regular smokers.   "
121918|NCT01690117|"     The purpose of the present study is to adapt, to implement and to evaluate an support program     for family caregivers of patients suffering from Alzheimers`Disease (AD). The intervention     was comprehensive developed and successful evaluated in the USA and is called Resources to     Enhance Alzheimers´Caregiver Health -second step (REACH II). To test the effectiveness of     this German adaptation of REACH II the present implementation study is designed as randomized     and controlled trial. Primary outcome is reducing family caregiver burden.   "
121919|NCT01690104|"     We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of     blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR     activator) and placebo will be given for a week to volunteers and blood pressure is measured     24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will     be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood     pressure.   "
121920|NCT01690091|"     The aim of the study is to evaluate the effect of metformin on myocardial function, insulin     resistance and selected metabolic markers in patients with type 2 diabetes and heart failure     (HF+DM+) in a cross-over, randomized, placebo controlled trial.      Hypothesis:      Metformin treatment in HF+DM+ group will lead to better myocardial function and load     tolerance in comparison to placebo. The degree of improvement will be linked to selected     metabolic parameters.   "
121921|NCT01690078|"     The investigators hypothesize that a functional computational model that simulates the     mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin     Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an     effective diagnostic and treatment planning tool.   "
121922|NCT01690065|"     The current standard therapy in previously untreated adults with chronic phase (CP) of CML is     imatinib and the result of long-term follow-up of IRIS study proves that imatinib for CML CP     is reasonable therapy.(1, 2) However, some patients were initially diagnosed as advanced CML,     accelerated phase (AP) or blastic phase (BP). Various chemotherapies were tried and were     found that there were no highly effective chemotherapies for CML BP.(3-11) Imatinib in     patients with these advanced CML is also disappointing because of low response rates as well     as short response duration, and sudden transformation to BC is found even in initial CML CP     patients. (12-17). Recent studies showed that nilotinib or dasatinib is better than imatinib     in terms of rapid response and higher molecular response in newly diagnosed CML     patients.(18-21) More potent bcr-abl suppression of nilotinib is supposed to be more active     than imatinib even in patients with advanced CML. However, nilotinib in patients with     imatinib-resistant or -intolerant CML BP showed low hematologic response and major     cytogenetic response.(22, 23)   "
121923|NCT01690052|"     The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in     the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects     between the treatment for xerostomia with cevimeline and with pilocarpine.   "
121924|NCT01690039|"     Purpose        1. To compare the performance of the two currently employed urinary acidifications tests in          stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.        2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on          urinary acidification in stone formers.   "
121925|NCT01690026|"     This present multi-site investigation compares a voluntary brief intervention for adolescent     alcohol problems to an educational comparison condition. Measures are taken at intake and at     4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal     change efforts and arrest progression of alcohol problems. This study tests cognitive     mechanisms of change and treatment characteristics and processes associated with youth     self-regulation to reduce or stop hazardous drinking.   "
121926|NCT01690013|"     Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1     in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter     syndrome have psychological complaints and physical discomfort. Some patients report a     positive effect of testosterone treatment, whereas others do not.      The aim of this study is:      (i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate     functional, physical and mental health in patients with Klinefelter syndrome.      Questionnaire concerning mental and physical health and life quality are sent out to patients     with KS and to age-, educational- and zipcode-matched men from the general population. The     questionnaire include questions about housing, income, marital status, fatherhood,     medication, chronic disease,school and education, attachment to the labor, sexual and     erectile function, life quality, mental and physical health, satisfaction with life and     symptoms of attention deficits hyperactivity disorders.   "
121927|NCT01690000|"     The aim of the study is to assess the effect of melatonin treatment in patients with     osteopenia on BMD, muscle function, quality of life and calcium homeostasis.   "
121928|NCT01689987|"     This phase I trial studies the side effects and best dose of hydroxychloroquine when given     together with cyclophosphamide, dexamethasone, and sirolimus in treating patients with     multiple myeloma that has come back after a period of improvement or does not respond to     treatment. Biological therapies, such as hydroxychloroquine, may stimulate the immune system     in different ways and stop cancer cells from growing. Sirolimus may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of     cancer cells, either by killing the cells, stopping them from dividing, or by stopping them     from spreading. Giving hydroxychloroquine together with sirolimus, cyclophosphamide, and     dexamethasone may be a better treatment for multiple myeloma.   "
121929|NCT01689974|"     An attractive area of research regards immune manipulations to recover some of the patient's     immune response to his/her tumor, a strategy that has the advantages of being both natural     and potentially long-lasting.[1] We propose to combine immunotherapy with radiotherapy     directed to a metastatic site, to create a hub for in vivo immunization to the tumor, to     enable tumor rejection at the other metastatic sites. This in vivo immunization is     explored as a viable alternative to an individualized vaccine approach. Preclinical data     generated by us and others support a proof of principle clinical trial that may open the     field to an alternative use of radiotherapy in a novel partnership with cancer     immunotherapy.[2]   "
121930|NCT01689961|"     Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who     enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess     weight gain puts mothers at risk for health problems such as diabetes and developing or     sustaining obesity after pregnancy, and puts their babies at risk of being born too large or     developing related health problems. Mothers will be randomized to a structured high dairy     protein diet and walking program or the usual care by their care provider. The investigators     research questions are: Will a structured nutrition and exercise program in pregnancy     compared to usual prenatal care increase the chance that mothers will achieve pregnancy     weight gain within the current recommendations; improve health measures, in mother and infant     at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on     maintenance of bone status in the mother and bone health outcomes in the child in early life     (6 months); and to investigate the interactions between genes associated with bone health and     high dairy diet supplementation on bone status in mothers during pregnancy, and bone health     in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity     and adherence to the nutrition plan will be assessed until birth and at follow-up with their     infants at 6 months after birth. The research team will ensure new information is quickly     transferred to programs to assist women to have healthier pregnancies.   "
122038|NCT01688635|"     The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of     LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of     LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each     period, a single injection will be administered before undergoing a euglycemic clamp that     lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects     will be documented. Study participation is expected to last up to 14 weeks.   "
121931|NCT01689948|"     Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its     prevalence and its medical and social consequences, AD represents a dual challenge to public     health and society. The elderly want to stay in their homes even when their lives are altered     by a chronic progressive disease. Their caregivers claim in turn a support at home. But this     desire is questioned because of the characteristics of the disease, e.g. the altered     relational function by the cognitive impairment and the behavioural disorders associated.      Outpatients non-drug therapies represent a potential support that adapts to patient with an     AD or mixed dementia, especially in their milder forms.      The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention     at home and its acceptability by both the patient and the caregiver.      The study of its efficiency in terms of autonomy will be the next step.   "
121932|NCT01689935|"     This research study aims to compare different methods for helping difficult to treat or     scarring (cystic) acne, ALA-PDT and i-PDT.      There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been     reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses     a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.      Levulan® is applied directly to facial/back acne. This is the way that it is usually applied.     Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where     the Levulan® was applied is exposed to a red light for activation.      The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin     through the skin pores to where the glands are. PDT destroys the glands reducing the acne     lesion.      Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure     also has some side effects. Some of the side effects include pain, burning sensation during     the procedure, and redness, tenderness, and swelling after the procedure.      At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators     developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT     is aimed at reducing the side-effects of ALA- PDT.      The difference between these two procedures is that i-PDT uses a light source that will     prevent Levulan® accumulation in the normal skin surface. The investigators would like to     find out if Levulan® will be placed only inside the sebaceous glands.   "
121933|NCT01689922|"     The primary objective of this study is to compare the effectiveness of standard for our     practice postoperative physical therapy (PT) program to a PT program that incorporates lower     body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and     fusion surgeries.   "
121934|NCT01689909|"     Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However,     no studies have determined whether treating insomnia decreases the risk of suicidality. We     have new data indicating that (1) the link between insomnia and suicidal ideation holds true     in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are     related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction     of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal,     depressed insomniacs may reduce suicide risk in a multi-site clinical trial.   "
121935|NCT01689896|"     This research is being done to see whether testosterone replacement in men who take     opioid-based pain medications and have low testosterone levels will show improvement in pain     tolerance, pain perception and quality of life.      Some men who take opioid-based medications (narcotics) for pain develop low testosterone     levels. Research has shown that low testosterone levels may make a person more sensitive to     pain. This means that if a person with a painful condition develops low testosterone level as     a result of his pain medications, he might become more sensitive to pain and so may need     higher doses of pain medications for pain control.      Testosterone is a male hormone that is important for sperm production and the development of     male characteristics such as muscle mass and strength, fat distribution, bone mass and sex     drive. Testosterone hormone replacement therapy has been used for decades to treat men with     low testosterone levels (male hypogonadism). Testosterone replacement therapies are available     in the form of an injection into the muscle, implants under the skin, oral capsules taken by     mouth, topical gels applied to the skin, and skin patches.      This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin.     Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low     testosterone levels).      Men with non-cancer related pain who take opioid-based medications for pain and have low     testosterone levels may join this study. (A low testosterone level is defined as early     morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone     of 50 ng/dl or less)).   "
121936|NCT01689883|"     The overall objective of the study is to test whether the use of small electrical currents to     stimulate proprioceptors of the upper limb has potential for improving robot-assisted     upper-limb rehabilitation in stroke survivors.   "
121937|NCT01689870|"     This is an open label, two-phase study combining a dose escalation Phase 1 with a     proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom     treatment with ipilimumab is indicated.      The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and the     secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor     response assessed by the Immune-related Response Criteria.      The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives     are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.   "
121938|NCT01689857|"     Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment     of surgical scars.      Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™     Normal Randomization: Table of random number   "
121939|NCT01689844|"     The Five Plus Nuts & Beans Study is a randomized, controlled trial to compare two strategies     for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into     practice for 120 African American participants who are on stable doses of antihypertensive     medications. The first arm of our study offers minimal DASH-oriented dietary advice along     with a food credit at a local supermarket where they make their own decision of what to eat.     The second arm consists of a single one-hour session with a nutrition expert who provides     choices and places an on-line order from a community grocery store (Santoni's Market) with     targeted purchases of fruits, vegetables, nuts and beans. Our primary outcome is change in     blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine     potassium excretion, and self-report consumption of fruits and vegetables during the same     period.   "
121941|NCT01689818|"     Poor sleep quality has been recognized as a major public health concern in the world. The     prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated     that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety,     falls, or cognitive impairment in the elderly, which may compromise their daily activities     function and quality of life.      Recently, researches have demonstrated the associations between insomnia and endocrine system     dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it is an     important issue to improve sleep quality of the elders. The side-effects of pharmacological     treatments and high-cost of cognitive behavior therapy limit their accessibility and     effectiveness, and exercise training has been expected to provide an alternative intervention     for insomnia. However, the long-term impact of insomnia on health-related fitness and     metabolic function, and the effect of exercise training remain inconclusive. Therefore, the     study hypothesis is that exercise training affect functional performance and quality of life     in community-dwelling elderly with insomnia.   "
121942|NCT01689805|"     Atopic dermatitis is a common disease which affects about one million people in Finland at     some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin     and a defect in skin barrier function. The filaggrin protein plays a central role in the skin     barrier function and studies indicate that about 30% of patients with atopic dermatitis have     a mutation in the filaggrin gene. The aim of the study is to investigate whether a mutation     in the filaggrin gene affects the clinical treatment outcome in patients with atopic     dermatitis. If a mutation predisposes to a worse response to treatment, this could be     examined and those patients with the mutation could be given extra treatment support for     their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic     population is studied in the control group.   "
121943|NCT01689792|"     To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium     Picosulfate/Magnesium Citrate solution.   "
121944|NCT01689779|"     While vitamin D insufficiency [25(OH)D <30 ng/mL] is common in the general population,     hypovitaminosis D may affect 40-80% of patients in the perioperative setting. Recent evidence     also suggests that surgical stress may be associated with a 40% reduction in circulating     25(OH)D levels when compared to preoperative values. Moreover, the derangement in     perioperative 25(OH)D levels may be sustained for up to 3 months after surgery. This finding     has potential implications regarding modifiable risk factors for surgical site infections     (SSIs), which account for nearly 40% of all nosocomial infections. On aggregate, SSIs result     in 3.7 million extra hospital days per annum and an added burden of $1.6 billion in annual     healthcare costs. A growing body of evidence suggests that robust postoperative immune     function is associated with a lower risk of SSIs. At the same time, vitamin D is increasingly     recognized as a key regulator of the innate and adaptive immune systems. Yet, optimization of     perioperative vitamin D status remains grossly understudied. Although our overarching aim is     to study the impact of vitamin D status on SSIs, the focus of the current investigation is to     determine whether the administration of a bolus oral dose of cholecalciferol (vitamin D3)     in the preoperative setting alters vitamin D status in the perioperative setting (compared to     a placebo). The investigators elected to conduct the current study in patients who will     undergo colorectal surgery since these patients are historically at higher risk of developing     SSIs and therefore would be ideal for future investigations.   "
121945|NCT01689766|"     Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to     identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma   "
121946|NCT01689753|"     The aim of the trial was to assess whether use of the TEGO connector was able to reduce the     incidence of a composite endpoint of TCC-related dysfunction (TCC-D)or TCC-related bacteremia     (TCC-B) in chronic hemodialysis (HD) patients carrying the TEGO® connector vs controls     receiving trisodium citrate 46.7%.   "
121947|NCT01689740|"     This study will examine symptoms of posttraumatic stress disorder (PTSD) in people before and     after psychotherapy with 25 mg followed two hours later by 12.5 mg or 125 mg followed two     hours later by 62.5 mg methylenedioxymethamphetamine (MDMA) in order to see if this treatment     is safe and can help reduce PTSD symptoms. Participants will be randomly assigned to one of     the two doses of MDMA given in two sessions scheduled three to five weeks apart. They will     prepare for the sessions before the first one and they will work with psychotherapists in     conventional (non-drug assisted) psychotherapy afterwards. Symptoms of PTSD and depression,     sleep quality and general psychological health will be measured at the start of the study and     2 and 12 months after the second session.   "
121948|NCT01689727|"     Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This     Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a     ligand (EC20) designed to bind to the folate receptor. The study is designed as an     open-label, baseline-controlled study.   "
121949|NCT01689714|"     The folate receptor is overexpressed in many types of cancer, including ovarian and     endometrial cancer, and the level of folate receptor expression increases with the stage of     the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic     radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide     an effective method to determine folate receptor-positive (FR+) target tumors, thereby     assisting in the identification of those patients who may benefit from folate-targeted     therapy.   "
121950|NCT01689701|"     The investigators performed a double-blind parallel study in a group of Subjects Showing     Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks.     Endoscopic observations were performed before and 4 weeks after the treatment, and the cure     and improvement rates were investigated.   "
121951|NCT01689688|"     The purpose of this study is to evaluate serial changes of neointimal coverage after     everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.   "
122039|NCT01688622|"     Glypican4, CTRP3, CTRP5 are emerging novel adipokines mediating obesity and inflammation     related disorders. RBP4 and adiponectin are well known important adipokines. Therefore, we     examine the circulating levels of theses adipokines in the subjects with or without metabolic     syndrome. Furthermore, we tried to clarify the effect of exercise on the circulating these     adipokines.   "
134767|NCT01520844|"     A consortium of research teams has studied the immunovirological characteristics of these     patients:      The ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study   "
121952|NCT01689675|"     Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health,     quality of life and societal productivity. Early intervention for pain following acute MSIDs     may prevent secondary complications of chronic pain, disability, reduced quality of life or     lost productivity. The investigators goal is to evaluate the efficacy of a computer-based     self-management intervention for reducing pain and improving function in persons treated in     on-site physical rehabilitation centers.      The specific aims are:1) evaluate the efficacy of a computer-based self-management     intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2)     determine long term impact during a six month follow-up period; and 3) determine whether     reductions of pain and improved function translate into reductions in lost work time days     away from work, restricted work days, worker's compensation costs and re-injury rates during     the 6 month follow-up.      Persons with sprain/strain injuries at risk for poor pain control will randomized to either:     1) control condition - standard care in the rehabilitation center plus computer exposure or     2) standard care plus computer-based self-management pain intervention. Assessment will be at     baseline, treatment completion, 3 and 6 months. The primary outcome measures are     self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are     days away from work, restricted work days worker's compensation costs and re-injury rates.     The investigation will also provide unique and valuable information regarding patients     acceptance and use of computer-based interventions following acute injury. By establishing     the utility and efficacy of computer-based pain management interventions for MSID the     investigators have the potential to improve the health and quality of life of persons with     injuries, improve productivity and develop new methods for health care delivery.   "
121953|NCT01689662|"     The folate receptor (FR) is overexpressed by many different cancer types, including renal     cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent     could provide an effective method to identify folate receptor-positive (FR+) cancer patients     that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly     suspected metastatic renal cell carcinoma with at least one target lesion detected by a     diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this     study.   "
121954|NCT01689649|"     The purpose of this dose optimization study is to assess tolerability and efficacy of     topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive     or have failed one anti-epileptic drug (AED) treatment in monotherapy.   "
121955|NCT01689636|"     Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of     the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four     subjects with known or suspected ovarian cancer.   "
121956|NCT01689623|"     The purpose of this study is to evaluate effects of steady-state concentrations (constant     concentration of medication in the blood) of TMC435 on the single dose pharmacokinetics (what     the body does to the medication) of atorvastatin, the active metabolites ortho- and     parahydroxylated atorvastatin, simvastatin and the active metabolite simvastatin acid. Plasma     hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitory activity after a single     dose of atorvastatin or simvastatin, either alone or in combination with TMC435 will be also     evaluated.   "
121957|NCT01689610|"     The purpose of this non-interventional study is to collect data on the efficacy and safety of     Nab-Paclitaxel in the routine application.   "
121958|NCT01689597|"     This pilot study intends to establish the efficacy of 2 different doses of epidural morphine     for pain management after perineal trauma when using multimodal analgesia as well as the     feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal     delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural     morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid     consumption for breakthrough pain in the first 24 hours.   "
121959|NCT01689584|"     The aim of the COVAR project is to classify reliably a maximum of VUS of the French database     in order to use them for the genetic counseling. The results obtained through this study will     have a major impact on clinical management of the patients and their families conducting in     some cases to propose a prophylactic surgery.   "
121960|NCT01689571|"     The study is designed to look at the safety, tolerability and efficacy of 2 different doses     of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a     day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001     after an allergen challenge.   "
121961|NCT01689558|"     1) Observe and compare the curative effect of endostatin/recombined Endostatin in alliance     with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced     nasopharyngeal darcinoma; 2) Evaluate the security and tolerability in endostatin/recombined     Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to     treat the local advanced nasopharyngeal darcinoma.   "
121962|NCT01689545|"     The purpose of this study is to determine whether a combined individual and structural level     stigma reduction intervention is effective in reducing high risk injecting and sexual     behaviors among HIV positive injecting drug users.   "
121963|NCT01689532|"     The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single     therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who     have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).   "
121964|NCT01689519|"     To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared     with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients     with unresectable locally advanced or metastatic melanoma, as measured by progression-free     survival (PFS), assessed by the study site investigator.   "
121965|NCT01689506|"     This clinical study compares two fluid resuscitation treatments in patients suffering from     burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be     administered as infusion solutions. It will be evaluated whether Volulyte® is effective and     safe, and provides any benefit.   "
121966|NCT01689493|"     The purpose of this study is to assess the effectiveness of an adherence protocol     intervention among stented patients to improve adherence to antiplatelet therapy (primary     endpoint). Secondary endpoints will assess whether the intervention reduces cardiovascular     events (ACS, stent thrombosis, re- hospitalization and coronary angiography,     revascularization, all-cause mortality) and its cost-effectiveness.   "
122020|NCT01688791|"     This trial will be conducted in three parts. Part A is a dose escalation trial followed by a     dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. The     primary hypothesis of this trial is that administration of vintafolide in combination with     carboplatin and paclitaxel is safe and tolerable. Part B is a single dose, dose escalation,     pharmacokinetic (PK), and QTc interval trial. The primary objectives include determination of     the maximum single tolerated dose of vintafolide and to evaluate the effect of this single     maximum dose on the QTc interval. Part C is a weekly dose escalation trial of vintafolide     followed by a dose confirmation. The primary hypothesis of this part is that weekly     vintafolide has acceptable safety and tolerability in participants with advanced cancers.   "
121967|NCT01689480|"     It is now accepted that physical activity is not deleterious in myopathies, including     muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD),     aerobic training has been reported to be associated with physiological and functional     positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup et     al. (2007) studies suggest that the combination of endurance and strength trainings is even     more relevant. However, only a few controlled and randomized studies have been conducted on     this topic and the impact of such training programs on skeletal muscle regenerative     capacities has not been addressed yet. Moreover, due to the fact that training programs are     mainly performed on short-term supervised periods, there is a lack of knowledge regarding     long-term effects, patient's autonomy and whether or not practice of regular exercise can be     maintained in patient's daily life. Also, only a few experiments report an integrative view     of potential benefits of such programs on functional, biological and quality of life.   "
121968|NCT01689467|"     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human     trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue     recovery after exercise. The investigators measured fatigue recovery parameters , including     lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood     pressure.   "
121969|NCT01689454|"     Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the     live birth rate in IVF patients with a previous history of pregnancy loss.      Couples requiring IVF treatment and with a past experience of implantation failure will be     included in the study.      Controlled ovarian stimulation protocol will consist of an agonist down regulation and     follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or     intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2     atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv,     Denmark) will be adopted throughout the culture period. In the control group, inseminated     oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio,     Måløv, Denmark), maintaining unchanged all other culture conditions.      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1     respectively. The endometrial support will be the same in the two groups.   "
121970|NCT01689441|"     Observational studies among critically ill patients have shown strong associations between     vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and     mortality. It is unknown whether vitamin D deficiency contributes directly to adverse     outcomes or whether it is simply a biomarker of severity of illness or overall health status.     However, vitamin D plays a key role in host defense, largely by stimulating production of the     anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration     of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.   "
121971|NCT01689428|"     Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the     live birth rate in IVF patients with a previous history of pregnancy loss.      Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical     pregnancy will be included in the study.      Controlled ovarian stimulation protocol will consist of an agonist down regulation and     follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or     intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2     atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv,     Denmark) will be adopted throughout the culture period. In the control group, inseminated     oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio,     Måløv, Denmark), maintaining unchanged all other culture conditions.      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1     respectively. The endometrial support will be the same in the two groups.      The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a     25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As     secondary outcome the investigators will assume a 5% of increment in ongoing implantation     rate after 12 weeks in the group with EmbryoGen medium.   "
121972|NCT01689415|"     It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood     pressure reduction - together with antithrombotics - remain crucial in stroke prevention.      This pilot study will examine the effect of renal nerve denervation in patients with     treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24     hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6     and 12 months after the procedure.   "
121973|NCT01689402|"     What happens in the borderzone of a cerebral hemorrhage remains widely onknown and furhter     the best timing for doing MR to look for vascular pathology in cerebral hemorrhage has not     yet been determined. In this study we do acute MRS, a non-invasive imaging mathod to detemine     the biochemsty in the border zone and structural MRI for vascular malformation. We repeat     structural MRI after 8 weeks.   "
121974|NCT01689389|"     The aim of the study is to describe patient characteristics (demographic and clinical) and     the patterns of use of Quetiapine XR in patients receiving the drug for the first time in     real-life practice regardless the final diagnosis.   "
121975|NCT01689376|"     The purpose of this Managed Access Program is to provide regorafenib to patients diagnosed     with metastatic and / or unresectable GIST who have progressed after standard therapy.   "
121976|NCT01689363|"     This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers     using an intradermal skin test.   "
121977|NCT01689350|"     The purpose of this study is to compare the genotype-based personal prescription of     cyclophosphamide with the traditional prescription.   "
122021|NCT01688778|"     The aim of the study is to investigate the effect of telemedicine among the group of     type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the     patients with regards to vulnerability and social resources and to determine wich groups     benefit the most from telemedicine.   "
122022|NCT01688765|"     The purpose of this study is to investigate the structural, functional and chemical brain     abnormalities in patients with first episode psychosis and assess the evolution of these     abnormalities during the course of the disease.   "
134815|NCT01520220|"     The purpose of this study is to determine a dose of LY2784544 that may be safely administered     to participants with myeloproliferative neoplasms.   "
121978|NCT01689337|"     This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to     evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast     growth factor-18 [rhFGF-18]) as an adjunct treatment to subjects following microfracture     (MFx) surgery for cartilage injury of the knee.      Primary Objectives        -  To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as          adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in          the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of          cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery        -  To evaluate the safety profile of Sprifermin (AS902330) when administered          intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage          injury of the knee      Secondary Objectives        -  To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to MFx          for cartilage injury repair through symptomatic outcomes and quantitative MRI          measurement   "
121979|NCT01689324|"     This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced     diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose     in adolescents in Japan.      Primary Objective:        -  To assess the immunogenicity of Tdap (SP306) when administered as a single dose in          Japanese adolescents      Secondary Objective:        -  To assess the safety of Tdap vaccine when administered as a single dose in Japanese          adolescents.   "
121980|NCT01689311|"     The purpose of this study is to compare the ability of an isolated sample of uterine muscle     tissue (in a tissue bath) to contract in the presence of various drugs. The drugs     studied--uterotonics--are typically used to contract the uterus when a pregnant patient     continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin,     ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.      The investigators will be testing isolated uterine muscle samples to increasing     concentrations of these four drugs in three patient populations: non-laboring, laboring     without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile     measures will be measured and compared between all groups. The investigators hypothesize that     oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients,     and all four drugs will induce different patterns of contractions.   "
121981|NCT01689298|"     The purpose of this study is to compare the ability of an isolated sample of uterine muscle     tissue (in a tissue bath) to contract in the presence of various drugs. The drugs     studied--uterotonics--are typically used to contract the uterus when a pregnant patient     continues to bleed after delivery. Oxytocin is an old standard, but seems to suffer from a     desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to     clinicians as a replacement for oxytocin directly after certain types of Cesarean section.      The investigators will be testing isolated uterine muscle samples after pre-treatment with     oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin.     Contractile measures will be measured and compared between all groups. The investigators     hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and     carbetocin-induced contractions, and oxytocin and carbetocin will induce different patterns     of contractions.   "
121982|NCT01689285|"     A new paediatric formulation (oral liquid) has been developed for flexible and accurate     dosing of valacyclovir in children. To establish the bioavailability of this new formulation,     healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The     concentration of valacyclovir in their blood after exposure to the oral liquid will be     measured and compared to the tablet.   "
121983|NCT01689272|"     The purpose of the study:        -  To estimate the role of morphological, clinical, biochemical and imaging studies at          stages of kidney transplantation (medical therapy, explantation, preservation,          transplantation).        -  To improve the ways of preserving optimal functional parameters of renal transplants.   "
121984|NCT01689259|"     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for     bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102     2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased     dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to     compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of     TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).   "
121985|NCT01689246|"     The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment     of subjects with mild to moderate Alzheimer's Disease.   "
121986|NCT01689233|"     The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment     of subjects with mild Alzheimer's Disease.   "
121987|NCT01689220|"     The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in     Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).   "
121988|NCT01689207|"     This is a randomised, double-blind, 3-part study designed to investigate the safety and     tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when     both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single     administration, and following multiple administrations of ATM-AVI in healthy male and female     (females of nonchildbearing potential) volunteers both young and elderly.   "
121989|NCT01689194|"     This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using     Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to     evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.   "
122023|NCT01688752|"     This is a prospective cohort study assessing measures of cardiometabolic status, body     composition, IR and GH response to stimulation after therapy in children (age 7-21 years)     treated for ALL. Patients and sibling controls will be recruited from the Pediatric     Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.   "
122138|NCT01687257|"     This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF)     plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic     hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to     receive study drug for 48 weeks or take part in an untreated observational arm for the first     24 weeks followed by study drug for another 48 weeks.   "
121990|NCT01689181|"     Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is     a core component of negative symptoms. It has been suggested that the physiopathology of     apathy is not a single entity but may be multiple, depending on which specific process or     macrofunction is disrupted during completion of GDB. In line with this notion, Levy and     Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing:     'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been     associated with executive dysfunction, functional impairment and poor outcome. However, the     neurobiological underpinnings of apathy in schizophrenia are poorly understood.      Primary objective: confirm that chronic schizophrenic patients are apathic compared to     healthy volunteers      Secondary objectives:        -  investigate if apathy is related to a particular aspect of the disease (i.e. negative,          positive symptomatology and/or deficit form)        -  investigate if apathy correlates with executive dysfunction        -  investigate if apathy is associated with a specific mechanism using an experimental task          specially designed to investigate the different mechanism (i.e. 'a-motivation',          'cognitive inertia', and 'uncoupling')        -  investigate if there is a volumetric abnormality affecting the executive system in          apathic schizophrenic patients        -  link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits          according to a specific subtype of apathy in the apathic schizophrenic group   "
121991|NCT01689168|"     Tobacco use is the number one killer of Americans today. Most current smokers have tried and     failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and     withdrawal from smoking can lead to physical symptoms such as irritability, anxiety,     nervousness, depression and insomnia.      This study will examine the effects of tobacco cessation counseling and chiropractic     treatments on smokers who desire to quit.   "
121992|NCT01689155|"     This is a passive-surveillance study that will accrue subjects for surveillance. For each     accrued subject, surveillance for outcomes will continue for six months following the first     dose. If a second dose is given within that time, then surveillance will be continued for six     months following the second dose.      Observational Objective:        -  To describe and characterize adverse events occurring after vaccination with Menactra          vaccine.   "
121993|NCT01689142|"     Primary Objective:      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of     change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese     patients with type 2 diabetes mellitus.      Secondary Objectives:      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting     plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose     (SMPG) profile.      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of     hypoglycemia   "
121994|NCT01689129|"     Primary Objective:      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of     change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese     patients with type 1 diabetes mellitus      Secondary Objectives:      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting     plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose     (SMPG) profile.      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of     hypoglycemia   "
121995|NCT01689116|"     This is a single-center, multiple-dose, randomized, double-blind, double-dummy,     placebo-controlled, active-comparator, parallel study in healthy volunteers.   "
121996|NCT01689103|"     This project is studying the role of the therapeutic alliance between the therapist and     patient in the outpatient treatment of persons with alcohol use disorders.   "
121997|NCT01689090|"     The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins     affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are     studied using the Dynamic Vessel Analyzer.   "
121998|NCT01689077|"     The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia     following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours     therapeutic hypothermia.   "
121999|NCT01689064|"     The purpose of this study is to determine if there is a significant difference in sinonasal     disease specific quality of life and utility scores between patients undergoing the posterior     septectomy or Stamm approach during endoscopic pituitary adenoma resection.   "
122000|NCT01689051|"     Diabetes and high blood pressure are risk factors for developing heart disease. An increase     in the number of diabetes patients is expected. This increases the number of patients with     heart disease, and since the vast majority with diabetes die from heart disease, it is     extremely important to investigate how these diseases can be prevented and treated.      Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can     expand blood vessels, thus lowering blood pressure, but it is not known whether the effects     is found in humans, which we will investigate.      Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is     solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1     has an effect on the muscles which increases the uptake of sugar. We investigate whether     GLP-1 enhances the absorption of sugar in the leg.      The investigators also examines whether these effects are greater in people with diabetes     then in healthy.   "
122001|NCT01689038|"     Assess the binding rate of F17464 to cerebral receptors in healthy volunteers.   "
122002|NCT01689025|"     This trial is conducted in Europe and the United States of America (USA). The aim of the     trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic     lupus erythematosus (SLE) concomitantly treated with stable background therapies.   "
122003|NCT01689012|"     This study seeks to evaluate the effects of facial exercises on aging of the face.   "
122024|NCT01688739|"     The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated     in healthy subjects and migraine patients. As part of the secondary objectives, this study     will be conducted to characterize the pharmacokinetics (PK) profile of AMG 334 after single     SC or IV doses in healthy subjects and migraine patients as well as to characterize the     effect of AMG 334 on the capsaicin-induced increase in dermal blood flow after single SC or     IV doses in healthy subjects and migraine patients.   "
122025|NCT01688726|"     The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing     the tear film of dry eye patients with an unstable tear film.   "
122004|NCT01688999|"     Background:      - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is     approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian     tumors respond to it. Researchers want see if cabozantinib can be a safe and effective     treatment for urothelial cancer.      Objectives:      - To test the safety and effectiveness of cabozantinib for advanced urothelial cancer.      Eligibility:      - Individuals at least 18 years of age who have advanced urothelial cancer that has not     responded to standard treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Tumor tissue samples will also be collected. Imaging studies          will also be performed.        -  Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Participants will continue to take the study drug for as long as their cancer does not          worsen and side effects are not too severe.   "
122005|NCT01688986|"     The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to     gather health, family history of disease, environmental exposures and lifestyle data on adult     EPR subjects. The EPR is a registry established to collect and store DNA samples from 20,000     volunteers from North Carolina and to serve as a resource to scientist investigating     genotype-driven translational research of chronic conditions. Under this new protocol, we     will administer a health and exposures survey to all EPR subjects. The information collected     in the survey will be used to better characterize the EPR population thus making it more     useful to NIEHS researchers. The survey contains approximately 200 questions. Data from the     survey will help researchers develop hypotheses, design follow-up studies, and select     appropriate subjects.      The survey will be administered to EPR subjects using a modified version of the Dillman Total     Design Method (TDM) for surveys. This method requires following specific time-dependent steps     for survey administration that incorporate both self- and phone administration and other     types of phone and mail contact. The goal of TDM is to maximize subject response rates.   "
122006|NCT01688973|"     This randomized phase II trial studies how well tivantinib with or without erlotinib     hydrochloride works in treating patients with metastatic or locally advanced kidney cancer     that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth.   "
122007|NCT01688960|"     This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/     SAR307746) in combination with aflibercept (ziv-aflibercept in the U.S.)   "
122008|NCT01688947|"     The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of     V116517 versus placebo.   "
122009|NCT01688934|"     The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of     V116517 versus placebo.   "
122010|NCT01688921|"     The purpose of this study is to determine if the administration of a seasonal flu vaccine     using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and     syringe administration, as measured by laboratory tests of immune response.   "
122011|NCT01688908|"     To evaluate the efficacy of endoscopy screening on esophageal cancer (EC) and determine the     most cost-effective strategy of endoscopy screening in high risk population of China, 668     villages of Hua county, a high risk area of esophageal cancer, were randomized into screening     arm and control arm in a ratio of 1:1 and the total sample size is over 30,000 (~16,000 per     group). Participants in the screening arm will accept standard endoscopy examination to     detect early esophageal cancer and no screening were designed in control arm. The incidence     of advanced EC and EC-specific mortality will be compared within the two groups to test the     hypothesis that endoscopy screening would detect early stage cancer and the incidence of     advanced stage EC and EC-specific mortality will be lower than control group.     Cost-effectiveness analysis will also be conducted to find the most cost-effective strategy     of endoscopy screening in rural China.   "
122012|NCT01688895|"     The initial objective of this protocol is to assemble a well-documented group of patients     with confirmed diagnoses of the erythropoietic protoporphyrias, including autosomal recessive     Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP) for clinical,     biochemical, and genetic studies. The long-term objectives are (1) to conduct a longitudinal     investigation of the natural history, complications, and therapeutic outcomes in people with     erythropoietic protoporphyria, (2) to systematically investigate the psychological effects of     the erythropoietic protoporphyrias on children and adults, and (3) to investigate the     correlation between the identified genotypes and the resulting clinical presentation, also     determining the possible interaction of other genetic markers.   "
122013|NCT01688882|"     To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous     pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is     broken down by the body and the impact it has on different blood and tissue markers will also     be explored.   "
122014|NCT01688869|"     The purpose of the study is to gather information about patients with mild traumatic brain     injury in order to develop guidelines for evaluation and treatment.   "
122016|NCT01688843|"     The objective of this study is to gather data to establish the safety, performance and     effectiveness of the INGEVITY pace/ sense leads.   "
122026|NCT01688713|"     Brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung     cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are     important approaches to the treatment of brain metastases from NSCLC. Known to us, epidermal     growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the     blood-brain barrier and show promising antitumor activity against brain metastases from     NSCLC, especially for EGFR mutation patients. However, due to the lower concentration of     tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of     drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR     inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the     Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It is     a challenge whether the further dose escalation of Icotinib will enhance its concentration in     cerebrospinal fluid and thereby improve its therapeutic effect. Here the investigators     examine the therapeutic effect and side-effect of double dose of Icitinib in treating     patients with brain metastases from NSCLC who have suffered from the failure of conventional     dose treatment.   "
122027|NCT01688700|"     A higher percentage of radical resection is reported in studies using neoadjuvant     chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant     chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a     humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent     trial is a clinical phase II trial designed to assess the efficacy of the combination of     Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with     resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and     toxicity   "
122028|NCT01688687|"     Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification     imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous     studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal     polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are     limited data exploring the application of pCLE to gastric lesions, and this is the first     study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the     final specimens obtained from endoscopic resection as a reference standard. The aims of this     study were (1) the accuracy of pCLE compared to conventional forceps biopsy using     histopathology results following endoscopic resection as a reference, and (2) comparison of     real time in-vivo pCLE diagnosis with that of blinded off-line pCLE diagnosis, and     off-line interobserver agreement.   "
122029|NCT01688674|"     NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms     receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during     the 72 hours of admission in Special Care Unit- Mulago Hospital.      ALTERNATE HYPOTHESIS      • Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30%     compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in     the first 72 hours of admission.   "
122030|NCT01687699|"     Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we     demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis     (HD) patients. In the present study, we assess whether low-dose spironolactone treatment     reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD     patients. The investigators' hypothesis is that aldosterone receptor blockade by     spironolactone reduces the risk of both CCV morbidity and death among HD patients.   "
122031|NCT01687686|"     The role of lipids as risk factors for cardiovascular events is well-documented, although     events studied have largely been broad classes without specific detail. This study will     examine a more refined set of endpoints.   "
122032|NCT01687673|"     This Phase II trial is being developed following the completion of a Phase I study of the     combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced     hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD)     and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly     plus sorafenib 200 mg (oral, twice daily).   "
122033|NCT01687660|"     Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A     open-label randomized controlled trial. 249 participants will be included. Three arms:     acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.   "
122034|NCT01687647|"     Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this     population relies on repeated CT-scans which are more accurate for detection of peripheral     lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using     automate cytometry may be of interest in this population, alone or in combination with     CT-scan.      An ancillary study will evaluate the interest of blood predictive biomarkers.   "
122035|NCT01687634|"     In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive     health care model that increases the opportunities for families to make healthy choices -- in     their homes, schools & communities. The project's key element is: Lay community health     workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to     pregnant mothers & newly-delivered mothers who have agreed to participate in the research     study.      Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months     post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use     during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare     adherence.      Investigators will implement the study with 6 MMs, who will maintain an average caseload of     16 women each across an 18-month period. Each participant will be visited (or receive the     intervention by telephone) twice per month.      Separate Assessment Team members will conduct assessments at: Baseline, within a week of     birth of the target child, and 6 months from birth.   "
122036|NCT01688661|"     The sniffing position has been regarded as a standard position for direct laryngoscopic view.     This study evaluated the effects of the age and gender on the advantage of the sniffing     position compared with simple head extension for laryngeal view during direct laryngoscopy.   "
122037|NCT01688648|"     The aim of the present study is to compare the antiarrhythmic and myocardial protective     effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing     coronary artery bypass graft.   "
122040|NCT01688609|"     This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab,     paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or     carry cancer-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing.   "
122041|NCT01688596|"     The primary objective of this study is to assess if injection of local anesthetic to the     laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain     after surgery.   "
122042|NCT01688583|"     The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix     in chronic non-cancer pain.   "
122282|NCT01685372|"     The purpose of this study is to determine whether Fluzone High Dose increases the immune     response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone     in immunocompromised children and young adults. Safety and efficacy data will also be     collected.   "
122043|NCT01688570|"     While baseline weakness is clearly an important factor that contributes to disability post     stroke, neuromuscular fatigue (the acute reduction in force production) of the paretic     musculature likely compounds strength deficits and further exacerbates disability. The     proposed study aims to improve our understanding of the mechanisms of neuromuscular fatigue     in people post stroke in order to optimize strength training. In healthy individuals, both     central (neural) and peripheral (muscle) factors are determinants of neuromuscular fatigue,     but preliminary data from our laboratory suggests a greater contribution of central     components to neuromuscular fatigue in the paretic musculature. Although cortical pathways     are clearly disrupted post stroke, it is likely that brainstem pathways, known to have     neuromodulatory effects on spinal motor circuitry, are more involved in the sustaining of     force in the paretic leg, compared to the non-paretic and control legs. Therefore, the     purpose of this proposal is to examine the role of descending neuromodulatory pathways of the     brainstem in neuromuscular fatigue post stroke (Aim 1) and to correlate brainstem-related     changes in neuromuscular fatigue to walking function (Aim 2). The investigators propose that     stroke survivors' decreased capability to sustain force overtime results from the diminished     ability of spinal motoneurons to respond to brainstem neuromodulatory inputs (serotonin     (5-HT) and norepinephrine (NE)). Aim 1 will quantify stroke-related decreases in motor output     sensitivity to a 5-HT and NE reuptake inhibitor (SNRI), serotonin antagonist, or placebo     during sub-maximal intermittent fatiguing knee extension contractions. If motoneurons are     desensitized to descending monoamines in chronic stroke patients, then they will be less     sensitive to the effects of drugs that increase monoamine levels. The investigators predict     that in response to the SNRI or serotonin antagonist, the paretic leg will show less change     in time to task failure and a smaller reduction in strength as compared to the non-paretic     and control legs. For Aim 2, the investigators predict that stroke subjects with the highest     walking function will demonstrate the greatest fatigue-related changes in response to the     SNRI. This proposal adopts an innovative model of motor impairment post stroke by including     the role of subcortical structures in neuromuscular fatigue.   "
122044|NCT01688557|"     The trial will compare results of screening colonoscopy performed by means of conventional     colonoscopy and using new visualisation techniques during endoscopic examination.        -  Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning          (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band          imaging (NBI) will be used for innovative colonoscopies        -  Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used          for conventional colonoscopies Endoscopists will archive all images and establish          presumptive diagnosis based on the results of different visualisation techniques. All          endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological          lesions will be performed to establish final diagnosis. The main outcome measure is          diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.   "
122045|NCT01688544|"     Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic     polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics     of Ilaprazole.   "
122046|NCT01688531|"     Exploratory, international, multi-centre, randomized, investigator blinded study in acne   "
122047|NCT01688518|"     This will be a randomized, single-blind, active-controlled, two-period crossover study in     adult volunteers to compare the duration and depth of anesthesia between Synera® and     Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening     Visit, two Treatment Periods, and a Follow-Up Phone Contact.   "
122048|NCT01688505|"     Hypertension in midlife is an independent risk factor of late life cognitive dysfunction or     dementia. Chronic hypertension cause vascular damage and cerebral ischemia, which ultimately     gives rise to the cognitive dysfunction or dementia.      A recent study showed that high visit-to-visit variability in clinic systolic blood pressure     (BP) was a strong independent predictor of stroke. This finding suggests that high clinic     systolic BP variability itself as well as chronic hypertension may cause vascular damage and     cerebral ischemia. Therefore, high clinic SBP variability may be also an independent risk     factor of cognitive dysfunction or dementia.      Vascular damage leads to the diminished autoregulatory capacities of cerebral arteries. The     brain with the reduced autoregulatory capacity may be more vulnerable to BP fluctuation.     Therefore, high BP variability may be more harmful in patients with damaged vessels (for     example, in patients with cerebral small vessel disease).      Previous data about BP variability and cognition revealed very controversial. Some studies     showed poor cognition in patients with high BP variability, but others did not.      The previous studies were mostly based on cross-sectional designs, and performed in     small-sized heterogeneous population for primary prevention. The harmful effect of high BP     variability may be clearer in the population with damaged vascular bed, such as cerebral     small vessel disease. The previous studies usually used ambulatory BP monitoring (ABPM).     However, recent data suggested that variability in BP on ABPM may be a weaker predictor of     vascular events than be visit-to-visit variability in clinic BP.      The investigators sought to find whether high visit-to-visit variability in clinic BP is     related with poor cognitive function in patients with cerebral small vessel disease.   "
122049|NCT01688492|"     The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab     with abiraterone acetate plus prednisone has on the patient and the prostate cancer.     Abiraterone acetate plus prednisone are drugs that lower testosterone (testosterone     stimulates prostate cancer growth). Abiraterone acetate plus prednisone is a treatment for     patients with prostate cancer.      Abiraterone acetate plus prednisone has not been used together with ipilimumab before. This     study will test how they work together. Each patient will receive abiraterone acetate,     prednisone and ipilimumab.   "
122050|NCT01688479|"     Acute radiation skin reactions (ARSR) occur in the majority of patients undergoing     postoperative radiotherapy (RT). Some patients experience more severe reactions such as dry     and/or moist desquamation but most patients experience mild reactions e.g. erythema (Lopez et     al., 2005). The radiation dose, volume, RT technique and previous treatment, such as type of     surgery and previous chemotherapy, are factors that might impact on the risk for ARSR     together with patient-related factors such as body mass index (BMI), smoking status and     previous skin damage (Porock et al., 1998; Wells et al., 2004). In a pilot study (n=93) of     the frequency of ARSR in patients with breast cancer who underwent adjuvant RT it was shown     that 93% developed ARSR, mostly mild reactions. Patients reported low scores on pain and     itching (Sharp et al., 2011). Over 80% of the patients reported adherence to the skin care     recommendations which included application of a thin layer of Essex® cream, a non-perfumed     aqueous cream, on the irradiated area at least two times a day (Sharp et al., 2011). The     effects of skin care products containing Calendula Officinalis (marigold plant) on ARSR in     patients with breast cancer were investigated in a randomized clinical trial (Pommier et al.,     2004). Patients in the experimental group, treated with calendula cream had a statistically     significant lower incidence of severe ARSR, pain and treatment interruptions in comparison     with the patients in the control group, treated with trolamine.      The purpose of this blinded, randomized clinical trial is to compare two topical agents,     Calendula Weleda® cream and Essex® cream, in terms of efficacy to reduce the risk of severe     acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast     cancer.      Patients were instructed to apply a thin layer of the assigned cream twice a day, starting at     the onset of RT and continue until two weeks after termination, or until the ARSR is healed.     The application should include the whole treatment area including the armpit and     shoulder/back area in patients treated with modified radical mastectomy. Patients are also     advised to not apply the cream within two hours before the RT in order to avoid possible     build-up effect. Daily wash with perfume free soap and tap water are recommended and patients     are advised to refrain from use of other topical agents in the irradiated area.      The primary endpoint is the efficacy to reduce acute radiation skin reactions (ARSR),     assessed with the Radiation Therapy Oncology Group/The Organization for Research and     Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at     follow-up.      Secondary endpoints include patient reported outcome measures; Quality of Life Questionnaire     (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms experienced from the     irradiated area (visual analogue scale). Patients' experiences and adherence to the topical     agents are also evaluated.      A total of 400 patients are required to detect a true absolute reduction in the proportion of     patients with ARSR, from 35% with standard treatment (Essex® cream) to 20% with the     experimental treatment (Calendula Weleda® cream), with a significance level of 5% a power of     90%. With this sample size, 95% confidence intervals for the difference in proportions are     estimated to be in the order of ±10%. Assuming a rate of 5% of non-responders, the target     size has been set to 420 patients.   "
122075|NCT01688154|"     Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after     an acute or chronic consumption in rodents. In this study, we aimed to investigate the     effects of an acute consumption of proanthocyanidins before a breakfast meal in humans.     Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape     seed proanthocyanidins in humans should be elucidated as well as its activity on vascular     function.   "
122059|NCT01688362|"     The purpose of this study is to further define the optimal non-surgical treatment strategy     for partial thickness rotator cuff tears. The specific aim of this study is to determine the     outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet     rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to     receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be     evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one     year to determine the outcomes for each treatment. The hypothesis is that there is no     difference in healing rate or functional outcomes in patients treated with corticosteroid     injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.   "
122309|NCT01685021|"     This is an open-label, multicentre study to characterize the safety and preliminary efficacy     of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell     acute lymphoblastic leukemia (B-ALL)   "
122051|NCT01688466|"     Background:      - Pomalidomide is a drug that alters the body s immune response. It may help people who have     chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when     immune cells in the transplant try to attack tissues in the person who received the     transplant. GvHD is not easy to treat, and often does not respond to standard treatments.     Researchers want to see if pomalidomide is a safe and effective treatment for GvHD.      Objectives:      - To test the safety and effectiveness of pomalidomide for GvHD that has not responded to     standard treatments.      Eligibility:      - Individuals at least 18 years of age who have GvHD that has not responded to standard     treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will also be collected. A lung function test and imaging studies will also be          given.        -  Participants will take pomalidomide capsules once a day for 4-week periods called          cycles.        -  Treatment will be monitored with frequent blood tests and imaging studies. Saliva          samples and skin and mouth tissue biopsies will also be collected during treatment.        -  Treatment will continue for six cycles (6 months), unless the GvHD gets worse or side          effects are too severe. If the GvHD has improved at the end of the six cycles,          participants may be able to continue to take pomalidomide for up to six more cycles.   "
122052|NCT01688453|"     Background: The prevalence of overweight and obesity continues to increase in socially less     advantaged populations but is stabilizing even is decreasing in socially more advantaged     populations. The PRALIMAP trial highlighted the effectiveness of structured screening and     care management in decreasing the prevalence of overweight and obesity in high school     adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened     care management (CM) for socially less advantaged adolescents in school in the short and long     term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and     obesity among socially advantaged adolescents.      Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight     and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35     state-run schools of the Vosges department (northeastern France) for the academic years     2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as     advantaged are allocated to the standard-CM and those less advantaged are randomized to     standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr     each performed in high school and supervised by a healthcare mobile team specialised in     overweight and obesity care management for adolescents. The strengthened-CM consists of 5     collective sessions with the same standard operating procedure as the standard-CM with     supplementary interventions between each session: strengthened solicitation with the     adolescent and the family, peer-led educational sessions, motivational interviews, financial     support for physical activity practice, cooking classes and multidisciplinary consultation     meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are     collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end     of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after     the intervention=T2). Process evaluation data are also collected during the trial.      Expected results: To confirm the effectiveness of overweight CM for adolescents in a school     setting and to highlight or not the effectiveness of specific strengthened interventions     adapted for socially less advantaged adolescents to maintain social equality in access to     overweight care.   "
122053|NCT01688440|"     When babies are sick, or are born prematurely, they sometimes need an endotracheal (ET) tube     to assist their breathing and/or a nasal canula. The investigators must periodically irrigate     the ET tube to prevent them from being plugged up by secretions. The investigators also, due     to the drying effects of nasal canula, periodically moisten the nasal passages of babies.     Presently 0.9% saline is the solution being used for moistening of the ET tube, nose, as well     as oral cares will infant is not eating. However, scientists have recently learned that     saline can destroy the body's natural antibacterial properties in the windpipe, nose, and     mouth.      The investigators have developed a new solution to be used in place of saline for     endotracheal (ET), nasal, and oral cares. The investigators' new solution is patterned after     the natural fluid in the windpipe, nose, and mouth.      Study Hypothesis:        1. Patients who receive ETCare will have no increase in adverse events related to its          administration, compared with 0.9% saline.        2. Patients who receive ETCare will have a lower proportion of tracheal aspirates where          pathogens are reported.        3. Patients who receive ETCare will have a lower proportion of tracheal aspirates where          leukocytes are reported.        4. Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.   "
122054|NCT01688427|"     This research is being done to test whether mobile technology will reduce possible     communication barriers between women and their home visitor; to improve assessing for health     problems that could affect their pregnancy; to help in the delivery of information and     actions to improve the health of the woman and their child.   "
122055|NCT01688414|"     This pilot clinical trial studies imaging during surgery in diagnosing patients with     prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate,     bladder, or kidney cancer   "
122056|NCT01688401|"     The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in     the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of     the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing     the local delivered dose while minimizing systemic toxicity. It also provides a treatment     option for these patients at the time of tumor recurrence.   "
122057|NCT01688388|"     This clinical trial is being conducted to find out the effects (good and bad) of giving the     full radiation treatment for breast cancer as a single dose of radiation during surgery for     breast cancer. This single fraction intraoperative radiotherapy with electrons will study the     toxicity, local control and cosmetic outcome.   "
122058|NCT01688375|"     ABSTRACT:      In patients with obstructive jaundice, multi-organ dysfunction may develop. The aim of this     study is to evaluate the effect of ursodeoxycholic acid on liver functional restoration on     patients with obstructive jaundice after surgical or endoscopic treatment.      Patients with obstructive jaundice will be divided into two groups: (A) test group in which     will be administered ursodeoxycholic acid twenty-four hours after endoscopic or surgical     procedure and will last fourteen days, and (B) control group.      Serum-testing will include determination of bilirubin, alanine transaminase, aspartate     transaminase, gama-glutamyl transpeptidase, alkaline phosphatase, albumin, and cholesterol     levels. These parameters will be determined one day prior endoscopic or surgical procedure,     and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or     surgical intervention.      Our hypothesis is that patients with obstructive jaundice under treatment with     ursodeoxycholic acid will have better outcome than patients in control group.   "
122136|NCT01687283|"     This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III     local registration study for a treatment period of 12 weeks. This study aims to assess the     effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of     Chinese adult and adolescent patients with severe persistent asthma for a treatment period of     12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of     fluticasone propionate inhalation solution will also be assessed.   "
122060|NCT01688349|"     The purpose of this trial is to investigate the impact of cortisol on adipose tissue     functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit     changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to     visceral obesity and features of the metabolic syndrome. The aims of this study will be        -  to compare the pattern of gene expression between visceral and subcutaneous adipose          tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment;        -  to compare these patterns of gene expression with those of two control populations:1/          healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar          degree of insulin resistance.   "
122061|NCT01688336|"     This single arm, multi-center phase II clinical trial will assess the safety and efficacy of     FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and     borderline resectable (BR) pancreatic cancer.   "
122062|NCT01688323|"     To look at what types of measures can be used to predict how an older person will tolerate     chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw     to look at the different measures.   "
122063|NCT01688310|"     This proposed randomized controlled trial will provide important data which will inform and     enable the Mozambican government and global health programs to more effectively scale-up     circumcision services. The investigators postulate that voluntary medical male circumcision     using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method:     it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and     is more cost effective than any other currently available technique.   "
122064|NCT01688297|"     The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine     tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded     trial at a single site. The study was conducted under two separate protocols. Initially     single administrations at two dose levels (low dose and mid dose) of the oral vaccine was     tested in a placebo controlled study (37 subjects). And subsequently a single high dose of     the oral vaccine was tested in a separate placebo-controlled study (24 subjects).   "
122065|NCT01688284|"     The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent     pregnancy losses and the correlation between the numbers of it and embryo toxicity by     measuring the level of the Th2 cytokines in normal reproductive profile and in patients with     Recurrent Pregnancy Losses (RPL).   "
122066|NCT01688271|"     This study will determine the efficacy of a teaching program incorporating hybrid simulation     in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral     nerve block (CPNB).      This study will also examine the extent of practice change following participation in a     regional anesthesia teaching program incorporating hybrid simulation. In addition, this study     will assess remaining obstacles to incorporating the use of US-guided perineural catheters     through identifying potential future interventions and tool-kits for setting up perineural     catheter programs.   "
122067|NCT01688258|"     (i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum     (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation,     PCR).      (ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and 2     in patients with genital, anal and oropharyngeal ulcers by a new PCR.   "
122068|NCT01688245|"     Investigators aim to test the effectiveness of a text-message-based behaivoral intervention     in reducing binge drinking among young adults.   "
122069|NCT01688232|"     Medical and Scientific Background: Colorectal cancers (CRC) are the leading cancers in both     genders. This cancer is of prognostic severity. The prognosis of this cancer has not been     significantly improved. The treatment of colonic cancer is primarily based on surgery.     Adjuvant chemotherapy is proposed for metastatic cancers (stages III and IV). However nearly     30% of patients with localized cancer (stage II) will present a recurrence. Despite intense     research efforts, no markers of sufficient prognostic value (independent of TNM) are     available to identify this group of patients and justify intensified therapy. The natural     history of cancer involves interactions between the tumor and the immune system of the host.     The immune infiltration at the tumor site may be indicative of host response. We showed that     the density of intratumor memory T cells (CD45RO) and cytotoxic T cells (CD8) in tumor     regions (the core and the invasive margin) influenced the occurrence of early events of     metastasis (tumor emboli) and was strongly associated with prognosis of patients with CRC     (Pagès et al, NEJM-2005). This immune criterion was a better predictor of survival than the     gold standard histoprognostic data of tumor invasion (T stage and N) and allowed to     identify a group of patients at high risk of recurrence (*2). The availability of this immune     criterion in clinical practice could improve the prognostic assessment of patients and better     guide the therapeutic. A dedicated platform has been implemented in our hospital to speed up     the transfer of this immune investigation into the clinic. The investigation takes into     account the density of immune cell populations in tumor regions (the core and the invasive     front of the tumor). This methodology has been validated for the markers CD45RO, CD3 and CD8     and leads to the creation of an immune score (immunoscore ranging from IO to I4). We     validated the prognostic impact of the immunoscore in a retrospective series of 250     colorectal cancers. The main objective of this multicentric prospective clinical study is to     assess in clinical practice the immunoscore and measure its prognostic value. The cohort     study will include 400 patients with CRC stage I to IV (6 centers for inclusion; Paris-HEGP,     Dijon, Bobigny-Avicenne, Besancon, Poitiers, Rouen). Two years of inclusion and a follow-up     of 3 years for each patient will be performed (co-financing for data collection during the     4th and 5th year planned). For each patient, the pathologist of the center will send to the     immunomonitoring platform of HEGP tissue sections from a paraffin block containing the tumor     regions. The investigations will combine a step of immunostaining for CD3, CD8, and CD45RO     (Ventana automate) markers, high-resolution scanning of the stained slides and quantification     of digital images by an imaging module developed by our group from the program of Developer     XD of Définiens company. The immunoscore will be calculated and the score will be correlated     to the clinical data for the relapse and the survival. The secondary objective of this     program is to evaluate the prognostic performance of the immune infiltrate on the biopsies     performed for diagnostic purposes. This study will be conducted on patients of the cohort     whose biopsies were performed in the same hospital than surgery and whose samples are     available in pathology laboratories involved (representing 50% of cases). For the same     patients will be conducted a genetic investigation of the tumor to assess the MSI status, the     presence of a K-Ras and BRAF mutations. This investigation will be performed on tumor     sections from the same tumor block selected for the immunohistochemical analyses. The     sections will be processed by the Department of Biology, Hôpital Européen Georges Pompidou.     The prognostic performance of the immune investigations performed on tumor sections and     biopsies will be compared to that of genetic features of the tumor. Finally, a questionnaire     will be sent every six months along the monitoring of the patients to obtain information     concerning (i) the emergence of an immune disorder (such as allergy, autoimmunity,     inflammatory process) and (ii) the psychological status of the patients. The potential impact     of such parameters during the course of the disease on the prediction of the relapse and     survival obtained with the immunoscore performed at the time of surgery will be evaluated.     Expected results : This prospective study is an indispensable step for the clinical     validation of the prognostic value of the immunoscore. The secondary objectives should help     to precise the benefit of a concomitant analysis of the biopsy, the genetic features of the     tumor. The questionnaire should help to identify the clinical parameters to track along the     monitoring   "
122070|NCT01688219|"     The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological     components. The investigators examined innate and adaptative immune responses in SAPHO     syndrome as compared with psoriatic arthritis and rheumatoid arthritis.   "
122071|NCT01688206|"     This multi-center, open-label study will evaluate the safety, pharmacokinetics,     pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination     with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts     of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD     and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with     atezolizumab, intravenously every 2 weeks.   "
122072|NCT01688193|"     The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the     HCP1004 and VIMOVO 500/20mg in Healthy Korean Male   "
122073|NCT01688180|"     Patients with chronic diseases are at great risk of depression and anxiety.It is known that     depression and anxiety are one of the most common comorbidities associated with chronic lung     diseases such as asthma and chronic obstructive pulmonary disease.      However,to date,little is known about the rates and risk factors of depression and anxiety     symptoms in non-CF bronchiectasis;and no large-scale prospective studies have been performed     to investigate the effect of depression and anxiety on the healthy outcomes(such as number of     exacerbations and hospitalizations over the ensuing year).Our purpose is to fill these gaps.   "
122074|NCT01688167|"     This study proposes to balance supply and demand of male circumcision through a systematic     scale-up of coordinated biomedical surgical and behavioral counseling services. The study     will compare the combined biobehavioral sexual risk reduction intervention to the standard of     care, which focuses exclusively on the provision of circumcision services alone, with the     goal of optimizing both local and national HIV prevention efforts.   "
122419|NCT01683708|"     The aim of the present study was therefore to evaluate if the perioperative administration of     symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for     hepato-biliary and pancreatic surgery.   "
122101|NCT01687816|"     This is a prospective specimen collection study targeting patients presenting with Influenza     Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A     non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be     used. These nasal swabs will be collected in different volumes of viral transport media     (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected     biological specimen. The collection of nasal swabs samples will support the optimization of     point of care detection methods for respiratory viruses responsible for ILI and/or ARI.   "
122076|NCT01688141|"     Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%.     The study hypothesis is to ascertain if intensive primary care led disease management     programmes for CKD, supported by input from secondary care specialists will slow progression     of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD     registers.      The investigators have partnered with Nene commissioning, a practice based commissioning     group representing approximately 80 GP practices in Northamptonshire, to run this study. This     will be a cluster randomised trial of an intensive, secondary care supported, CKD management     programme in primary care vs normal CKD care. Randomisation will be at the level of the     individual general practice. All general practices associated with Nene commissioning will be     invited to participate. Randomisation of practices will be performed by the University of     Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking     randomised cluster trials.      The aims of the study are:        1. To determine whether reinforcement of best practice in the management of key aspects of          CKD care by clinical nurse specialists based in primary care, but with close links to          colleagues from secondary care, improves clinical outcomes.        2. To foster excellence in CKD care        3. To improve coding of CKD and prevalence on chronic disease registers.        4. To increase interest in, and capacity for primary care research in Northamptonshire.        5. To implement and evaluate a new model of partnership working between primary and          secondary care.      The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR).     Secondary outcome measures will be blood pressure control, proteinuria, incidence of     cardiovascular events,other biochemical parameters, referrals to secondary care and     hospitalisations and mortality.   "
122077|NCT01688128|"     The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based     Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild     cognitive impairment (MCI) by an open-label, controlled, crossover Trial.   "
122078|NCT01688115|"     The purpose of this study is to evaluate the efficacy of a video shown using an iPad,     compared to a standard treatment, to reduce preoperative anxiety in children who have to     undergo to elective surgery procedure   "
122079|NCT01688102|"     Participants in this study will be randomized to receive either oral vitamin D pills OR     ultraviolet light treatment. The investigators will compare how these two methods of raising     vitamin D levels will affect cholesterol levels.   "
122080|NCT01688089|"     The purpose of this study is to evaluate the safety and tolerability of escalating doses of     ODM-103 when given to healthy male volunteers.   "
122081|NCT01688076|"     This cross-over design study will evaluate the onset of action, efficacy, and duration of     botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without     subsequent muscle contraction.   "
122082|NCT01688063|"     The primary objective of Part A is to compare the change in elasticity measurements at     baseline and at 3 months between subjects who have had a resurfacing or tightening procedure     and those who have not. The secondary objective for Part A is to develop baseline elasticity     scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and     V-VI. The primary objective of Part B is to compare the age of the scar and surrounding     tissue with the elasticity measurements.   "
122083|NCT01688050|"     The TRANSFIX study is a clinical trial approved by US FDA to study the safety and     effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt     Thoracic Aortic Injury.   "
122084|NCT01688037|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses     (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia     (TD) symptoms.   "
122085|NCT01688024|"     The purpose of this study is to determine the effectiveness and safety of mitomycin C in the     treatment of primary sclerosing cholangitis (PSC).   "
122086|NCT01688011|"     The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights into     treatment regimens and sequencing of these regimens as they relate to clinical outcomes of     patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate     molecular and cellular markers that may provide further prognostic classification and/or     might be predictive of therapy outcomes.   "
122087|NCT01687998|"     The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in     participants with high-risk vascular disease (HRVD).   "
122088|NCT01687985|"     A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated     adults.   "
122089|NCT01687972|"     The proposed study is a randomized controlled trial with two arms. All patients admitted to     Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered     entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,     the patient will be randomized at time of cesarean section to receive skin closure by either     the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the     standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment     score (PSAS) will be obtained during this visit. The patient will then be contacted by     telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)     assessing her satisfaction with the resulting scar.   "
122090|NCT01687959|"     Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography     for acute biliary pancreatitis is a controversial issue. There are still many confounding     findings offering either early laparoscopic cholecystectomy within 72 hours following     endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is     known to be an important factor in peritoneal healing and adhesion formation. Measurement of     tissue concentrations of tissue-type plasminogen activator and its specific activity,     urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought     to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.   "
122100|NCT01687829|"     Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by     vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and     visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has     become used widely as an adjunctive procedure during MH surgery because the removal of ILM is     thought to reduce the tangential traction on the macula, a major factor in the pathogenesis     of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not     yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of     the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published     literature comparing surgical results with and without ILM peeling and and performed a     meta-analysis to determine whether there is any benefit or detriment anatomically and/or     visually.   "
122137|NCT01687270|"     This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults     who have had a liver transplant which has become re-infected with hepatitis C. The treatment     period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last     up to 72 weeks not including the screening visit.   "
122091|NCT01687946|"     RESOLVE's objective is to identify and characterize validated molecular targets capable of     shifting primary organ repair towards fibroproliferative wound healing.      Work package 2 (WP2) of RESOLVE includes the clinical study protocols within the RESOLVE     system evaluating different forms of pulmonary repair in humans ranging from normal repair     over mainly inflammatory to predominantly fibroproliferative repair.      Hypothesis      Fibrosis of the lung is an aberrant and intensified form of wound healing. It is the result     of an unresolved disturbance of both initiation and control of repair which is partly     age-related. As a result of the relentlessly activated wound healing reaction, mechanisms of     inflammation largely representing the condition of chronic inflammation within the peripheral     bronchial tree will aggravate this abnormal form of repair.      A systematic comparison of the molecular pathology of fibrotic repair representing        -  Varying intensity of fibrosis related to the pathology of usual interstitial pneumonia          (UIP),        -  Varying inflammatory mechanisms (UIP vs. Hypersensitivity pneumonitis [HP], acute and          chronic), and        -  Varying stages of age (Normal pulmonary repair in young and old individuals vs.          acute/chronic HP vs. UIP) will be able to        -  identify molecules capable of shifting regular repair towards fibroproliferative repair          and        -  elucidate their interrelationship with other molecules forming coordinated yet          misdirected metabolic responses characteristic for fibroproliferative repair.   "
122092|NCT01687933|"     There are different medicinal and non medicinal methods to control labor pain. Today, much     attention has been on non medicinal methods because of limitations and complications of     medical procedures. Virtual reality is a new and promising method of diversion of mind that     may have an impact on labor pain. This study was conducted to determine the effect of virtual     reality on the first stage of labor pain.   "
122093|NCT01687920|"     This study should estimate the dose proportionality of BAY94-8862 IR tablets.   "
122094|NCT01687907|"     The aim of this trial is to find out if active music listening during pregnancy and delivery     reliefs fear of childbirth, pain in delivery, need for analgesia during delivery and if there     is an effect on delivery complications. Also we try to find out if there is any influence on     mother-baby relationship.   "
122095|NCT01687894|"     Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia.     The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are     evaluated during surgery in BCP.   "
122096|NCT01687881|"     This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for     cervicogenic headache (CEH). If the method proves to be effective, it will provide a new     non-pharmacological treatment option for CEH. This is especially important since     pharmacological management has minor effect in CEH, and alternative treatment options are     warranted. The applied methodology of the study will aim towards the highest possible     research standards. This international study is a collaboration between Akershus University     Hospital, Innlandet Hospital and University of Oslo (UiO), Norway and Macquarie University,     Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and     medicine. By increasing the methodological quality of the investigators research to a very     high level, the investigators see the method to work as a guide to increase the quality of     chiropractic research in the future, as previous randomized clinical trials (RCTs) of CEH     used methodology showing room for improvement.      Study hypothesis:      CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo     (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low     amplitude) and no intervention (control group).   "
122097|NCT01687868|"     Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for     adverse neurologic events due to cerebral ischemia.      Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial     blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the     perioperative period.      dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically     appropriate for reducing bleeding for arthroscopic operation field.      The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on     cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in     patients undergoing arthroscopic shoulder surgery in the beach-chair position.   "
122098|NCT01687855|"     The aim of this study was to evaluate the dynamic changes of the tongue in patients with     obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using     Ultrafast Magnetic Resonance Imaging (UMRI)   "
122099|NCT01687842|"     Monocentric multidisciplinary study (psychologists, endocrinologists, psychiatrists, and     molecular biologists) to characterize social cognition in adolescents with Turner syndrome     (TS).      Inclusion criteria:        -  Turner syndrome with homogeneous 45,X karyotype.        -  Age between 8 and 18 years.        -  Somatic state compatible with the evaluation.        -  Functional language and IQ ≥ 80 for the transfer tests        -  Informed consent signed by the holders of parental authority, the patient and the mother          for her own participation (DNA collection).        -  Affiliation to Social Security (beneficiary or assignee).      The primary endpoint will be the overall score to the AQ (Autism Quotient) questionnaire and     to the SRS (Social Reciprocity Scale), in comparison to the expected scores for the general     population. For patients with scores above the threshold for SRS or QA validation of a     possible diagnosis of autism spectrum disorders will be performed with commonly used     diagnostic tools (ADIR (Lord et al, 1994), ADOS-G (Lord et al, 1999) and diagnostic criteria     of DSM IV-TR).      Secondary criteria will include the results of standardized tests to assess autistic features     (AQ, ADI-R, ADOS, DSM IV-TR criteria), intellectual efficiency (Wechsler scales), psychiatric     comorbidities (Kiddie-SADS) and sociocognitive profile (SpeX test, Social cognition,     Perception, eXecutive functions).      A DNA sample will be collected from the patient and her mother. The observation period is 2     days for the patient and about 1 hour for the mother. The total duration of the study is 3     years.   "
122133|NCT01687322|"     The investigators want to contact patients that underwent total hip replacement for the past     ten years. The investigators will ask them about their daily living, functioning and quality     of life.   "
122134|NCT01687309|"     A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of     single and repeat doses of 800 mg GSK2586184 in healthy subjects.   "
122102|NCT01687803|"     The overall goal of this study is to determine the health benefits associated with the 2005     Dietary Guidelines physical activity prescription in healthy, peri-menopausal women. The 2005     Dietary Guidelines specifically state that to avoid unhealthy weight gain, adults should     participate in 60 minutes of moderate to vigorous intensity physical activity on most days of     the week.   "
122103|NCT01687790|"     The primary hypothesis of this project is that using molecular breast imaging (MBI) in     evaluating women with equivocal mammographic or sonographic findings will demonstrate high     specificity in distinguishing benign from malignant breast disease and, as a result, decrease     the number of biopsies.   "
122104|NCT01687777|"     Surgical reconstructive procedures for rotator cuff tears present a number of limitations.     The few studies in which the repair integrity is evaluated, have shown the existence of a     high rate of reruptures in spite of the fact that the functional results obtained short-term     are satisfactory. Morphologic analysis from the sutures, after different follow-up periods,     has not shown satisfactory results.      Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells     (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the     function compared to cell-free tendon defect treatment.   "
122105|NCT01687764|"     The objective of this project is to test the combination of active or placebo Attentional     Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or     Psychoeducational Control Intervention (PCI) for anxiety disorders in children.   "
122106|NCT01687751|"     Cancer patients with very difficult to control symptoms at the Abbotsford (AC) and Fraser     Valley (FVC) Cancer Centers are referred and admitted to the Tertiary Palliative Care Units     at the Abbotsford Regional Hospital and Cancer Center(ARHCC). For symptom management,     patients are sometimes given midazolam continuously through a needle placed underneath the     skin. While effective in symptom management, midazolam can be sedating, leaving patients     unable to interact with loved ones in their last days.      This study is a pilot project. Before proceeding to a full-scale study, a pilot study or     feasibility study is often carried out first to test the design of a study, the likelihood     of successful recruitment or the acceptability of the intervention to potential subjects. The     basic idea is to find out whether it will be practical to proceed to a larger study that will     include more subjects. This type of study involves only a small number of subjects and     therefore the results can only be used as a guide for further larger studies.      The investigators also will determine whether palliative care cancer patients taking a     medication called dexmedetomidine would have improved rousability (more easily and fully     awakened) and symptom control (pain, shortness of breath, nausea or confusion) compared with     those taking standard of care which is receiving the medication midazolam. The use of     dexmedetomidine in other clinical situations (in the Operating Room or Intensive Care Unit     where the patient can still respond to the doctor) has been shown to be effective in symptom     control and to provide a better degree of rousability to patients but has not been well     studied in the palliative care environment.   "
122107|NCT01687738|"     Purpose: Overall lung surgery rates and black/white disparities have not improved during a     decade of documentation. The goal of this study is to incorporate lessons from the previous     prospective cohort study to optimize lung cancer surgery rates and narrow black-white     disparities for patients diagnosed with stage I or II, non-small cell lung cancer.      Participants: Stage I and II, non-small cell lung cancer at 3 participating sites.     Procedures: Phase I of the study has been completed. Phase I was a deidentified 3-year,     retrospective chart review, used to establish the baseline surgical rates for the     intervention. The patient enrollment phase of the study will move forward that will include     use of a real time registry to follow patient progression through clinical follow up,     diagnostic testing and treatment for biopsy proven or highly probable early stage, non-small     cell lung cancer. The patient enrollment portion of the study will start, September 2012. All     patients with Stage I or II non-small cell lung cancer who enroll in the study will be     entered into real time registries at every site. Patients' progress through the registries     including follow-up provider visits, diagnostic tests, and procedures will be transparent and     any missed appointments will be flagged. Feedback will be given to lung cancer providers in     both arms. The randomized trial will compare patients who receive usual care plus the     registry to those who receive the registry plus visits and calls from a trained cancer     communicator -educator (CCE) who is well versed in issues specific to lung cancer and trained     in active listening and communication that accounts for patients' limitations in health     literacy. The CCE will also use Kleinman's Patient Model to identify attitudes or beliefs     that represent barriers to recommended care that could potentially be addressed through     negotiation and more targeted communication.      The hypothesis is that an electronic warning system, data transparency, and enhanced     communication will optimize lung surgery rates and reduce racial gaps.   "
122108|NCT01687725|"     In patients with treatment resistant hypertension renal nerve ablation emerged as an     effective interventional approach of treating hypertensive disease with a progressively     increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is     one of the major underlying pathogenetic mechanism of the fall in blood pressure but the     precise mechanisms that causes the fall in blood pressure in the short-term and, in     particular, long-term remains elusive. The objective of the study is to understand the     pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic     nervous system. In 100 hypertensive patients most advanced technology will be applied, before     and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic     activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling     technique), local activity of the renin angiotensin system in the kidney (urinary     angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI     technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large     arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24     hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall     in blood pressure after renal denervation may help to identify those hypertensive patients     that profit most from renal nerve ablation in terms of blood pressure reduction.      The investigators propose the following hypotheses why a progressive decrease in blood     pressure happens, in addition to the decreased activity of the central nervous system, after     renal nerve ablation:      Short term effects:      A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the     kidney C)Exaggerated sodium excretion immediately after renal nerve ablation      Long term effects:      D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall     properties after 6 and 12 months   "
122109|NCT01687712|"     The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle     stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to the widely     used and marketed r-hFSH Gonal-f.   "
122135|NCT01687296|"     This is a multicentre, randomized, double-blind, double-dummy, active-controlled,     parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate     1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric     and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma   "
122207|NCT01686360|"     The purpose of this study is to test the effects of objective risk information about breast     cancer and mammography outcomes using a randomized control trial. Women between the ages of     35 and 49 will receive information about their personal risk for breast cancer and be     randomly assigned to receive data about a woman who should be screened, data about the     potential outcomes of screening, or data about breast cancer deaths. Two presentation formats     will be tested and compared.   "
122110|NCT01687621|"     The objective of this study is to develop and test a simple community-based diagnostic     algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated     community-based algorithms developed and tested in the sub-Saharan context where the     manifestations of omphalitis presentation may vary and diagnosis could be potentially more     challenging in infants with darker skin color. Given the current attention to cord care at     the global and national policy level, validated community-based algorithms will be needed to     allow primary health workers to identify cord infections and reduce associated morbidity.      After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health     facility for routine or sick visits will undergo two independent, parallel evaluations;     first, by a community level worker and second, by a Zambian medical doctor (gold standard). A     third independent assessment of a photo of the cord will be performed remotely by a     board-certified pediatrician. Using the on-site clinician as the gold standard, the     community-based algorithm and the photo assessment will be tested for concordance and the     sensitivity and specificity of the algorithm will be generated. Likewise, the remote     pictorial assessment will be compared to the gold standard to determine reliability of     diagnosis from photographs alone.   "
122111|NCT01687608|"     The purpose of this study is to evaluate the safety of single ascending IV doses of a Factor     IX (FIX) Gene Therapy in up to 16 Adults with Hemophilia B.   "
122112|NCT01687595|"     The purpose of this study is to evaluate the effect the HerpV vaccine has on recurring     episodes of genital herpes by evaluating viral shedding before, after treatment.   "
122113|NCT01687582|"     The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog     treatment on psoriatic skin lesions in patients with type 2 diabetes.   "
122114|NCT01687569|"     The purpose of this study is to determine whether added ingredient affects glycaemic     responses to a cracker snack.   "
122115|NCT01687556|"     Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris        -  major polyphenolic constituent in green tea        -  known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and          antimicrobial activities        -  lipid-lowering and antiandrogenic properties was reported        -  EGCG can improve acne vulgaris via one of the above mentioned actions.   "
122116|NCT01687543|"     Symptoms of Clostridium difficile infection is almost always induced as a complication to the     use of antibiotics. Most ICU patients are given antibiotics.      Probiotics has the ability to improve conditions in the gut and it has been shown in some     smaller studies that overgrowth of C. difficile can be reduced or prevented.      In this study the intention is to show with sufficient statistical power that a mixture of     two otherwise well studied probiotic strains reduces or prevents the incidence of emerging     colonisation with C. difficile in critical ill patients on antibiotics.      Half of the patients will be given a mixture of Lactobacillus plantarum 299 and Lactobacillus     plantarum 299v twice daily and the rest a placebo mixture.      Rectal swabs or faeces will be analysed for C.difficile and its toxins and the incidence of     new cases will be compared for the two groups.      White blood cells (WBC´s), C reactive protein (CRP), lactate, urea, and creatinine will be     followed daily as well as antibiotics, corticosteroids and all acid reducing medication.      Nutrition, enteral and total, and bowel habits will be recorded.   "
122117|NCT01687530|"     Certain types of fractures require surgical intervention that may involve the use of bone     grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer     from disadvantages such as soft tissue invasion of the fracture area, inadequate blood     supply, failure to encourage the production of bone and ectopic bone formation.      A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR     has been widely used in the field of dentistry since the 1980s to provide stable placement     for dental implants      The purpose of this study is to evaluate the safety, performance and initial efficacy of     Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma     applications.   "
122118|NCT01687517|"     Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs,     especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with     corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be     recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary     fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators     presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal     influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal     influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis     patients than in the general population. Similarly, it is unclear whether the vaccine     response is modified by the severity of the disease and treatment with corticosteroids and     immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which     are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine     response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The     demonstration of a vaccine response could allow reconsidering new vaccine approaches in     sarcoidosis.   "
122119|NCT01687504|"     Tuberculosis (also known as TB) is a common infection and a major cause of death in children.     Effective treatment using a combination of anti-tuberculosis (anti-TB) medications saves     lives, but dosages of these medications are not well established in children. Several     research studies have shown that the recommended dosages of the anti-TB medications in     children do not lead to adequate blood levels to kill the bacteria in some children. This     situation may lead to treatment failure and emergence of drug resistance. As a result, the     world Health Organization (WHO) recently recommended increased dosages for all the TB     medications in children. This study is being conducted to find out if the increased dosages     of the anti-TB drugs are safe and lead to adequate drug levels in the blood of children with     TB with or without HIV infection.   "
122120|NCT01687491|"     This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®,     conducted on two parallel groups of patients admitted in emergency for acute coronary     syndrome.   "
122121|NCT01687478|"     The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine     compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in     Chinese participants.   "
122420|NCT01683695|"     This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose     study that will enroll approximately 40 systemic lupus erythematosus subjects with active     lupus arthritis.   "
122122|NCT01687465|"     Lasers are important therapy in glaucoma. They are a pivotal point in treatment between     medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser     treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used:     argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT     including causing less damage to the tissue it affects. One of the potential patient centered     benefits of this laser is that it may be repeatable. It is even possible that the old laser     ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is     possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of     repeating laser therapies may delay surgical treatment and its complications. Also     understanding which laser to use will help eye doctors know how to treat their patients at     this point of the disease.   "
122123|NCT01687452|"     The aim of the investigators study is to demonstrate in healthy subjects and a cohort of     patients infected with HIV, the presence of miRNAs in circulating peripheral blood     microparticles (MPs).   "
122124|NCT01687439|"     Primary objective: functional imaging and quantitative imaging detection of the effects of     Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).      Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and     normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.   "
122125|NCT01687426|"     The purpose of this study is to determine the intraocular Pressure (IOP) lowering response     and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects     with open angle glaucoma or ocular hypertension.   "
122127|NCT01687400|"     This clinical trial studies potential genetic markers which might be used to predict which     patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This     study will contribute to the efforts to find effective and less toxic therapies to provide     durable remissions in a significant proportion of elderly AML patients.   "
122128|NCT01687387|"     Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab     (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute     Myeloid Leukemia (AML) in first complete remission   "
122129|NCT01687374|"     Hypothesis:      The investigators want to study whether parathyroid hormone improves healing of humerus after     a fracture. The investigators will assess healing of the humerus with Constant score.   "
122130|NCT01687361|"     Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in     order to increase or restore muscle capacities of hypoactive patients or patients with     articular trauma. Although this technique seems to be particularly adapted to muscle     rehabilitation, growing evidence is emerging regarding potential damaging effects of     electrically- induced isometric contractions in healthy humans. Recent studies have reported     a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased     muscle soreness and impaired force production as a result of NMESs. On that basis, further     studies should be conducted on these deleterious effects which might limit the clinical     application of NMES.      Over the last decade, many studies paid attention to branched-chain amino acids (BCAA)     supplementation as a potential prophylactic/therapeutic approach. The rationale of this     approach is that BCAA might increase protein synthesis and reduce protein breakdown through     physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin).     Additionally, BCAA could also be used as energetic substrate during exercise when glycogen     stores are depleted. Overall, previous results have supported the efficacy of BCAA     supplementation in attenuating muscle damage. Nevertheless, comprehensive studies     investigating the effect of amino acid supplementation on markers of muscle damage are still     scarce.      Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS)     are powerful non invasive tools allowing the exploration of skeletal muscle structure and     energy metabolism.      This ambitious project is devoted to the anatomical, functional and metabolic     characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of     muscle damage, including maximal voluntary force production, T2 values and apparent diffusion     coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise     (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance     for improving our knowledge of anatomic, metabolic and functional events related to BCAA     supplementation in the context of exercise-induced muscle damage   "
122131|NCT01687348|"     Prospective, monocentric, open-label study conducted in women requiring mastectomy and     eligible for tumescent infiltrative anaesthesia.      Blood samples will be collected during 48h after start of infiltration. Total and free     lidocaine concentrations measurements will be determined by gas chromatography. Visual     analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs     and adverse effects will be collected.      Population pharmacokinetic parameters will be estimated using NONMEM software and covariates     influence on parameters variability will be tested.      Primary outcome value: Population pharmacokinetic parameters with possible covariates     influence on variability.      Patients and period of study: n=30 patients enrolled during 24 months, total study duration:     30 months.   "
122132|NCT01687335|"     The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is     variable in function: the location and the extension of the tumor, of the general state , of     age, of the socio-economic class and the pain. The health consequences of a malnutrition are     very important: aggravation of the state of health, complications of treatment,     hospitalization, alteration of the quality of life and decrease the survival, and the     treatment response.      Nutrition being very important in patients, there are recommendations for the nutritional     care of these patients, formulated by the European Society for Clinical Nutrition and     Metabolism. The investigators do not know to what extent these recommendations are respected     in practice and their influence on the nutritional status and the quality of life of     patients.      The investigators therefore propose to assess the conformity of the nutritional care patients     in clinical practice in relation to the European recommendations and in a second time to     assess the influence of this compliance or non-compliance on the nutritional status clinical     and biological of cancerous patients under chemotherapy, on their quality of life, on their     response to treatment and on their survival.      The investigators will try to identify factors that may be linked to the non-compliance such     as the characteristics of the cancer disease, socio-demographic characteristics of the     subject and the factors related to the structure in which it is supported.   "
122139|NCT01687244|"     This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with     Syn3) when given intravesically to patients with high grade non-muscle invasive bladder     cancer who are refractory to or have relapsed from BCG therapy. The pharmacodynamics of     INSTILADRIN will also be studied by measuring the interferon (IFNα2b) levels excreted in the     urine. rAd-IFN is a non-replicating recombinant adenovirus type 5 (Ad5)-vector encoding the     interferon alpha-2b (IFNα2b) gene. Syn 3 is clinical surfactant excipient which enhances the     ability of the adenoviral vector to transfect cells in the bladder wall.   "
122140|NCT01687231|"     In the transplant community, there is debate regarding the most appropriate food services for     stem cell transplant patients. Recommendations regarding the use of low bacterial diets have     been based on theoretical concepts of reducing the risk of contracting infections from     pathogens found in food sources rather than clinical trials. The evidence for the use of a     neutropenic diet is weak. To date, there have been little to no randomized controlled studies     addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is     necessary as infection prevention in myeloablative stem cell transplant patients. For this     reason, our research is aimed at providing data to substantiate the use of neutropenic diets     in preventing infections in recipients of myeloablative stem cell transplants.   "
122141|NCT01687218|"     MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label     crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel.     The study population will be sexually active, HIV-uninfected males who are 18 years of age or     older, who report a history of receptive anal intercourse in the past 3 months. Each of the     study product regimens offers different advantages to participants seeking an effective HIV     prevention agent. How these relative advantages will compare in terms of safety,     acceptability, systemic and local absorption, and adherence will be examined within this     study.   "
122142|NCT01687205|"     Study Objectives:        -  To assess the impact of coitus (and semen) on the pharmacokinetics of tenofovir 1% gel          in female genital tract secretions, vaginal and cervical tissue and rectal tract          secretions        -  To assess the impact of coitus (and semen) on pharmacodynamics of luminal drug by          measuring the anti-HIV-1 activity in CVL samples      Study Summary:      MTN-011 will enroll heterosexual monogamous, sexually active couples, in which both partners     are healthy and HIV-negative. The female participants must be between the ages of 21-46     (inclusive) and currently using effective non-barrier contraception. Male participants must     be 21 years of age or older. This Phase 1 expanded safety study will assess tenofovir PK in     the genital tract secretions (CVL), rectal (rectal sponge) and both intracellular and     extracellular tissue compartments (vaginal biopsy) in the absence of, or following coitus.     Pharmacodynamics (antiviral activity) will also be assessed in CVL. MTN-011 will study the     timing in which coitus might have the greatest impact on these variables, which is when gel     is applied shortly prior to coitus in the absence of a drug reservoir.      MTN-011 will examine PK/PD in response to a single dose of 1% tenofovir gel applied shortly     before sex and compare to PK/PD assessments following a single gel application without sex.     Additionally, data obtained from a visit in which participants do not dose with gel and do     not have sex will serve as an additional control for the pharmacodynamic (PD) studies of the     antiviral activity in CVL. If tenofovir retains its antiviral activity following sex, then     the anti-HIV activity in CVL collected at the visit in which female participants dose with     gel and have sex should be comparable to that of CVL collected at the visit in which females     dose with gel and then do not engage in intercourse and significantly greater than the     endogenous anti-HIV activity in CVL obtained at the visit in which participants do not dose     with gel but do have sex and the visit in which no gel is administered and sex does occur.     Data analysis performed after the completion of enrollment and follow-up procedures will     demonstrate if there is an impact of coitus and semen on PK/PD when a single 1% tenofovir     dose is applied shortly prior to sex.   "
122143|NCT01687192|"     PRIMAVERA is a Phase IIa clinical trial, with the objective to assess the immunologic     response to HPV vaccine in a population of immunocompromised girls. The principal hypothesis     is that the immunologic response to tetravalent vaccine in girls who received     immunosuppressive treatment is comparable to the immunologic response in girls that are not     immunosuppressed.   "
122144|NCT01687179|"     Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the     combination of sirolimus and hydroxychloroquine is safe and well tolerated      Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy with     sirolimus and hydroxychloroquine results in improvement of indicators of disease, and whether     the gains are sustained after stopping therapy.      Specific Aim 3: To investigate the potential role of a LAM-specific peripheral blood     signature to predict rates of disease progression and determine responsiveness to combination     therapy.      This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted     to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken     orally daily. Up to 18 adult women with LAM will be enrolled.   "
122145|NCT01687166|"     The purpose of this study is to establish the safety and effectiveness of the Blazer     Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory,     recurrent, symptomatic, paroxysmal atrial fibrillation.   "
122146|NCT01687153|"     Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are common combat     related problems and may be associated with a greater risk of Alzheimer's disease (AD). The     purpose of this study is to examine the possible connections between TBI and PTSD, and the     signs and symptoms of AD on Veterans as they age.      The information collected will help to learn more about how these injuries may affect     Veterans of the Vietnam War as they grow older, as well as Veterans of the current wars in     Iraq and Afghanistan, who also have these types of combat related injuries.   "
122154|NCT01687049|"     Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon     cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing     statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown     that RYR has direct effects on androgen dependent and androgen independent prostate cancer     cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those     subjects with localized prostate cancer who have chosen to be managed by active surveillance.   "
122155|NCT01687036|"     Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System     consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole     Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events     (AEs).   "
122156|NCT01687023|"     The goal of this research study is to show that features derived from data gathered using     SHIMMER wearable sensor platform can capture adherence and proficiency in the performance of     exercises that are part of Tai Chi interventions.   "
122195|NCT01686516|"     Diffusion MRI employed in functional imaging has the potential to probe directly brain     activation instead of blood changes like the BOLD technique. The researchers investigated     these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion     functional MRI as well as anatomical (venography, tractography by diffusion) features in     young and aged subjects.   "
122208|NCT01686347|"     The aim of the investigators study is to demonstrate the association between fetal cardiac     rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine     and/or sufentanil.   "
122209|NCT01686334|"     The primary aim of this innovative immunotherapeutic study is to determine whether the     antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort     of patients and whether dendritic cell vaccination can significantly prevent relapse and     increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual     disease.   "
122147|NCT01687140|"     Pediatric obsessive compulsive disorder (OCD) is a relatively common and often severe     condition that can become chronic if untreated. One of the most effective treatments for OCD     is a type of cognitive behavioral therapy called exposure and response prevention (ERP). ERP     involves presenting a patient with feared objects or situations (the content of their     obsessional fears) in a gradual manner while helping them use coping techniques to refrain     from engaging in rituals (compulsions). Despite several studies suggesting that ERP is an     effective treatment for pediatric OCD, many youngsters fail to respond to this treatment, or     respond only partially.      An exciting recent finding from animal research is the ability of an established antibiotic     (traditionally used to treat Tuberculosis), D-cycloserine (trade name: Seromycin) to enhance     certain types of learning among rats. The type of learning that is enhanced is called     extinction learning and many researchers believe that extinction learning is the equivalent     process to what occurs during ERP; it is the process whereby repeated exposure to the object     of fear without any bad outcome causes the object to cease being associated with danger.     Several clinical trials using ERP and other forms of exposure treatment for adults with     anxiety disorders reproduced this finding from the animal literature; pairing DCS with     exposure treatment (comparable to extinction learning) resulted in greater fear reduction     than when no DCS was administered. The effects of DCS on exposure treatment for anxiety     disorders among children has been tested only preliminarily in one study of children with OCD     and results were unclear with children who received DCS augmentation showing non-significant     but increased levels of improvement as compared with children who did not receive DCS     augmentation.      In this study, 26 youngsters ages 7-17 with a primary diagnosis of OCD will be recruited and     assigned at random to one of the two treatment conditions. Youth in the DCS condition of the     study will receive 50 mg DCS 1 hr prior to each treatment session, while youth in the placebo     condition receive an identical placebo capsule 1 hr prior to each treatment augmentation     session. All participants will receive 180 minutes of CBT for OCD 4 days per week for 2 weeks     during their study participation (as included in IOP already). All families complete a     thorough evaluation no more than 5 days prior to receiving DCS on their 9th treatment visit     in IOP (third week), and at mid-treatment augmentation (after the 12th IOP treatment     session), post-treatment augmentation (after the 16th IOP treatment session), and 3-month     follow-up (12 weeks after the 16th IOP treatment session). The primary aim of this study is     to obtain preliminary data comparing the effects of the acute administration of DCS versus     placebo on symptom response to exposure treatment for pediatric OCD. Results from this study     will help to inform and refine future studies, and eventually, impact treatments for     pediatric OCD.   "
122148|NCT01687127|"     Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin folate     - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The underlying     biochemical mechanisms for how folic acid affects health outcomes however are unknown. The     naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and discussed as     an adequate substitute to folic acid. This study aims to determine the effect of folic acid     compared to 5-MTHF on cellular mechanisms. Stable isotope tracer protocols will be used that     allow determining the effect of folic acid on the dynamics of metabolic pathways in the human     body.      Hypothesis: Supplementation with high-dose folic acid alters the turnover rate of folate     dependent pathways in healthy humans; but 5-MTHF does not. Genetic variations in a key enzyme     of the folate metabolism will aggravate the effect of folic acid on the metabolic pathways.   "
122149|NCT01687114|"     This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful marker     of cranberry intake. We hypothesize the consumption of this cranberry beverage in a     progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy,     nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular,     endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index     (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women     in this age range are particularly vulnerable to urinary tract infection. Volunteers will be     asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a     weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot     urine samples each will be collected from subjects during the study. Urinary PAC-A2     concentration will then be determined to validate if it can serve as a marker of compliance     of cranberry juice consumption.   "
122150|NCT01687101|"     This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with     or without aura. STOPAIN is an over-the-counter product that is used for the temporary relief     of minor aches and pains of muscles and joints associated with simple backache, arthritis,     strains, bruises and sprains. We plan to have subjects apply the product during a single     migraine attack to see if it will alleviate the headache pain and associated symptoms.   "
122151|NCT01687088|"     Olfactory impairment is a common symptom of neurologic disorders and may be related to     dopaminergic dysfunction. Studies show that patients with migraine show increased sensitivity     to light and sound. In our previous study in episodic migraineurs, olfaction was similar to     age and sex-matched controls outside of attacks, but lower during acute attacks.      The hypothesis is that olfactory function in chronic migraine (CM) will have mild impairment     of olfaction at baseline but a more significant impairment during migraine or headache     exacerbations.      The investigators have two objectives:        -  To determine baseline olfactory acuity in subjects with CM and compare them to age and          sex-matched controls        -  To determine how olfaction changes during acute exacerbations of migraine in those with          CM      To execute this study, the investigators will interview subjects and controls to ensure that     they meet inclusion and exclusion criteria. After obtaining informed consent, subjects and     controls will complete a questionnaire survey regarding their history or lack of history of     headaches, smell sensitivity, osmophobia and current medication use and answer questions     about attack frequency, location of headache, duration of disease, use of medication for     pain, and disability. Both migraineurs and controls will take the University of Pennsylvania     Smell Identification Test (UPSIT) in the office.      After the first visit, migraineurs and controls will self-administer the UPSIT at home. They     will be required to return the second test to the Jefferson Headache Center.      The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT scores     between subjects and controls. To achieve a 90% power that the study will detect a     statistically significant difference between the mean UPSIT scores at a two-sided 5 percent     significance level, our sample size for both subjects and controls is 50.   "
122152|NCT01687075|"     The purpose of the study is to evaluate clinical performances of Cre8 in all comer population     in Subjects over 18 years old who are undergoing a clinically indicated coronary angiogram     and angioplasty on de-novo lesion located in native coronary arteries   "
122153|NCT01687062|"     Anemia is one of the most common health problems all over the world with around half of     preschool-aged children (<5 years) and one third of women affected. Nutritional iron     deficiency is a major reason for anemia in infants, young children and women of reproductive     age who have especially high iron requirements that are difficult to meet in regions where     the major diet is based on plant foods. So in Ethiopia, where injera is the major staple     food. Despite high levels of iron in tef, the most favored cereal for injera, the iron     bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.      The aim of this study is to determine the iron bioavailability in women from injera prepared     in a traditional way and investigate the potential of methods to improve the bioavaiability.     Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be     evaluated. Further the potential positive impact of phytic acid reduction on the iron     bioavailability will be investigated. The phytic acid reduction will be achieved in two     different ways, by addition of whole grain wheat as source of phytase and addition of a     commercially available microbial phytase. The studies will be conducted in healthy women     using stable isotope techniques.   "
122157|NCT01687010|"     Sepsis is a common cause for morbidity and mortality in critically ill patients. With the     development of medical skills, the mortality is still remain very high. Inappropriateness of     initial antibiotic treatment is an important risk factor for mortality and effective     antimicrobial administration within the first hour of documented hypotension was associated     with increased survival to hospital discharge in adult patients with septic shock. However,     the early treatment based on early diagnosis.But it is very difficult to diagnosis because of     lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful     to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore,     combine several biomarkers could enhance the diagnostic value.   "
122158|NCT01686997|"     Morbid obesity is an increasing medical problem in the western countries. It's related to     comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.     The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese     patients. A part of these patients will have disappointing results, and have weight regain on     the long term. Some studies show more weight reduction by increasing the biliopancreatic limb     in patients with morbid obesity.      The objective of this study is to investigate the effect of variations in the length of     biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery.     We hypothesize that longer biliopancreatic limb results in more weight reduction.      The study design is a prospective, randomized control trial. The patients will be randomized     in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.   "
122159|NCT01686984|"     The purpose of this study is to investigate how inspiratory flow pattern influences CO2     elimination in people without primary lung disease.      The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause     and high end-inspiratory flow, will promote CO2 exchange in the alveoli.   "
122160|NCT01686971|"     A questionaire for cancer patients without an active treatment in order to evaluate their     needs and/or demands.   "
122161|NCT01686958|"     This study is to evaluate that the MRI-guided transurethral ultrasound therapy system is safe     and feasible to ablate prostate tissue in men with localized prostate cancer.   "
122162|NCT01686945|"     This trial is conducted in Europe. The aim of the trial is to investigate safety,     tolerability, pharmacokinetics (the exposure of the trial drug in the body), and     pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a     long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male     subjects with type 2 diabetes (T2D).   "
122163|NCT01686932|"     Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in     their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50     mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding     postprandial blood-glucose normalization as well as protective properties regarding     hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic     patients a correlation has been described between hypoglycemia and abnormal heart function     (QTc-elongation), which can have severe consequences for the patients. This study aims for     the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in     insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of     hypoglycemic episodes with changes in heart-function measured by Holter-ECG.      The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than     sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function     caused by undetected hypoglycemic episodes.   "
122164|NCT01686919|"     Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in     Hedmark og Oppland, Norway. Patients with either BMI > 40 kg/m2 or with BMI > 35 kg/m2 and     complications who opt for gastric bypass surgery, go through a standard program including a     thorough clinical examination and information on the operation, followed by a learning and     coping program that consists of standard dietary advise for weight loss and includes weekly     visits during 8 weeks.      This research project concerns a subgroup in the patient population described above: morbidly     obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how     an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is     known that milk may cause stomach complaints and may make it more difficult to loose weight.   "
122165|NCT01686906|"     To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to     reduce and stabilize ectasia in eyes with advanced keratoconus   "
122166|NCT01686893|"     Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients with COPD Acute     testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients An     investigator-initiated, prospective, controlled, multicenter study   "
122167|NCT01686880|"     The purpose of this study is to assess the safety of transarterial radioembolization prior to     surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma   "
122168|NCT01686867|"     The underlying concept behind this feasibility trial is to achieve a reduction in indoor     smoke from biomass fuels and minimize changes in cooking practices such that it prompts one     of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel     sources used in developing countries include wood, dried dung, and agricultural waste. The     investigators propose to reduce indoor air pollution by replacing the household traditional     cookstove with an improved design that incorporates the following key elements:        -  Burner openings customized to the size and shape of the cooking vessels in the home.        -  Flue designed to draw air into the fire box under the cooking pots and pass it out          through a chimney.        -  A chimney with adequate height to create a draft and vented to the exterior.        -  An exterior port that has bidirectional openings to prevent backflow of smoke.        -  An access port for the chimney that permits cleaning of soot.      The investigators propose to use two types of improved cookstoves that meet these criteria.     As part of piloting activities, the investigators will test several different types of     commercially-available cookstoves with a chimney, and we may also want to test a locally-made     improved cookstove. The investigators want to evaluate those designs by comparing their     ability to reduce indoor air pollution, the reliability between cookstoves of the same type,     the functioning over time, the logistics of import/build locally, preferences and cultural     compatibility, and costs. The investigators will select two types of improved cookstoves to     use in the feasibility trial.      The study design will be a crossover intervention trial in which all patients will first have     a run-in observational period of 4 months with the traditional cookstove prior to     randomization. At baseline, the investigators will obtain sociodemographic information for     each household, respiratory outcomes and other health data for the participating women, and     cooking times and practices including the types of fuels used. All 40 patients at each site     will receive the two types of improved cookstoves, one after the other: 20 will be randomized     to receive the first type of cookstove with a chimney and the other 20 to first receive the     second type of improved cookstove with a chimney. The patients will be followed for 4 months     before the crossover. The investigators will assess cooking behavioral practices and     compliance with cookstove use monthly, and respiratory and environmental measures at the     mid-point of the 4 month period to minimize carry-over effects. At the end of second 4 month     period, the investigators will switch the order of the improved cookstoves and follow all     participants for another 4 months. The investigators will assess behavior, compliance,     respiratory and environmental measures as above. The study is expected to require 12 months     to complete.   "
122169|NCT01686854|"     Comparison between different treatments of obesity in the short and medium term: prescriptive     diet therapy compared to to cognitive-behavioral approach in the treatment of obesity     according to the method of clinical trial.      According to the Italian guidelines on obesity, the target to reach is the weight loss of 10%     compared to the initial weight, obtained in six months and maintained for the next 5 years.      The guideline considers six months as the time required to lose weight, but many patients are     not able to achieve this result. Since in clinical practice many patients fail to achieve     this weight loss in six months, it was decided to extend to 12 months the time to reach the     target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5%     on respect of the basal weight in six months.   "
122170|NCT01686841|"     To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ     System.   "
122171|NCT01686828|"     The purpose of this research study is to understand the effects of testosterone and estrogen     on the body's response to the hormone insulin.   "
122172|NCT01686815|"     This study aims to utilize state of the art procedures such as the frequently sampled     intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein     analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the     metabolic abnormalities associated with other atypical antipsychotic treatments, namely     olanzapine and risperidone, and offers an advantage over these other agents.   "
122173|NCT01686802|"     Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive     management of fractures, tendon release, etc. will be randomized to receive either ibuprofen     or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will     be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral     morphine will result in significantly lower pain scores on the Faces Pain Scale Revised     (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new     option for post-operative pain management in children.   "
122174|NCT01686789|"     The study aims to study the outcome of pharmacokinetics-adjusted dose ribavirin (plus pegIFN)     on the SVR in chronic HCV patients.   "
122175|NCT01686776|"     This is a prospective, validation study of a extempore made tracer compared with a     commercial. Studies with tracer have no medical effects but are used for studying human     physiology, in this case pharmacokinetic variables of endogenous albumin distribution and     turnover at different levels of inflammation.        1. Primary Objective:           - Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured          SERALB-125 give identical values of calculated blood plasma volume and capillary leakage          measured as transcapillary escape rate of albumin?        2. Secondary Objective:             -  How do three different measures of albumin turnover correlate in volunteers?             -  How do the pharmacokinetic parameters of endogenous albumin vary between the three               study groups?   "
122176|NCT01686763|"     Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after     subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of     ET-1 are not sensitive enough to predict the development of vasospasm representing the     average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a     technique able to detect molecule concentrations in a small perivascular area. The     investigators performed a prospective observational clinical study to test the hypothesis     that MD ET-1 concentrations should be a sensitive predictor for vasospasm.      Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale     admitted to the ICU were consecutively studied. All patients received surgery within 48 hours     from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and     samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels;     ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and     after 7 days two angiographies were performed to detect the degree and extent of vasospasm,     Transcranial Doppler and neurological evaluation were daily performed. Patients were then     classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV),     presence of vasospasm (CV), acute neurological deterioration (AND).   "
122177|NCT01686750|"     This is a cluster randomized trial to evaluate the effectiveness of integrated care centers     (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk     populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We     will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in     India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to     stratify sites according to key baseline characteristics. We will perform stratified     randomization to assign sites to either the ICC intervention or to standard services. ICCs,     which will be either IDU or MSM-focused, will provide an accepting atmosphere in which     members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and     testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be     scaled-up from existing governmental or non-governmental organizations and services provided     at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After     providing services in communities for two years, we will conduct an evaluation survey (with     biological and behavioral measures) of approximately 1000 subjects in the target populations     in each of the 22 study sites. Integrated care centers have the potential to improve access     to HIV prevention and treatment services among vulnerable, high-risk populations.   "
122178|NCT01686737|"     Breast cancer is the most frequent cancer in women and is associated with profound     restrictions of health-related quality of life and psychosocial health. More than     three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While     exercise interventions can improve fatigue in breast cancer patients, many patients request     complementary treatment approaches. Therefore, this study investigates the effects of yoga in     women with breast cancer compared to aerobic exercise and usual care.      It is hypothesized that yoga is more effective than usual care and equally effective as     aerobic exercise.   "
122179|NCT01686724|"     This study tests the effectiveness of a newly developed integrated school-home behavioral     intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The     intervention is implemented by school-based mental health professionals within school     settings.   "
122180|NCT01686711|"     To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with     diabetes mellitus.   "
122181|NCT01686698|"     Probiotics, due to their ability to modulate intestinal flora, intestinal permeability and     immune response, could decrease bacterial translocation and improve immune system alterations     in cirrhosis. This could lead not only to improvement in liver function and to prevent     bacterial infections and other complications but also to improve CD and to avoid its     consequences falls, HRQoL deterioration).      Recently, the investigators have observed that VSL#3 administration to rats with experimental     cirrhosis decreases bacterial translocation, inflammatory response and ascites formation,     without changes in intestinal flora. This suggests an improvement in intestinal barrier that     deserves further investigation.      VSL#3, through decreasing intestinal bacterial translocation and immune system modulation,     could improve cognitive function and prevent the consequences of CD, including falls and     HRQoL deterioration, in patients with cirrhosis.   "
122182|NCT01686685|"     Preterm children are at increased risk for autism spectrum disorders, with an estimated rate     of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore,     individuals with ASD who were born prematurely form a substantial body of children diagnosed     with ASD.      Premature birth confers an insult to the newborn at a neurologically vulnerable stage.     Prematurity associated changes in oxygen tension can be detrimental to developing organs, the     brain being one of the most rapidly developing organs in the second half of the pregnancy.     Changes in oxygen tension mediate activation of proteins that change the course of cell     development.      In this study, we plan to measure changes in the expression of 3 proteins that may be     affected by changes in oxygen level at birth. We will study the interaction between the     proteins' levels in the first few days after premature birth with a diagnosis of ASD at 2     years of age. The proteins are:        1. VEGF (Vascular Endothelial Growth Factor), a protein that takes part in creating new          blood vessels during embryonic development.        2. Hypoxia-inducible factor -1(HIF-1), a key protein that coordinates expression of          different genes, many with developmentally critical functions.        3. CXCR4, a cell surface protein that is activated by SDF-1. SDF- 1 is a molecule that          regulates migration of cells to their target destination during embryonic life. CXCR4 is          expressed in areas of the brain and on cells that are known to be associated with ASD.      We hypothesis that changes in oxygen tension in premature babies initiates a cascade of     events that lead to changes in cell mobility via abnormal CXCR4 expression. This change leads     to abnormal neurodevelopment.      The investigators' primary aim is to find if there is a correlation between postnatal levels     of expression of HIF-1, CXCR4 and VEGF and a diagnosis of autism at age 24 months. The     investigators' secondary aim is to find if there is a correlation between postnatal levels of     expression of HIF-1, CXCR4 and VEGF and a language or neurocognitive delay.      Methods:        1. Premature babies will be recruited in the first day post delivery.        2. Blood samples will be collected at 3 time points during their hospitalization, and the          expression of HIF-1, CXCR4 and VEGF will be determined.        3. Infants will undergo a complete developmental evaluation at 18-24 months of age .        4. Postnatal levels of HIF, CXCR4 and VEGF will be plotted against the results of the          developmental evaluation.   "
122183|NCT01686672|"     This study will demonstrate feasibility and collect pilot data via a pilot randomized trial     of 20 participants on the effectiveness of a web-based delivery system of behavioral plus     nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of     age that has been found to be efficacious in face to face delivery.   "
122184|NCT01686659|"     This is a multi-center cluster-randomized trial with the following Specific Aims:        -  To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC          transfusions in patients undergoing surgeries associated with a significant risk of          bleeding.        -  To evaluate if patients monitored with continuous noninvasive hemoglobin experience less          frequent complications and shorter hospital stay compared with patients who are not          being monitored with continuous noninvasive hemoglobin.      Accordingly, the study hypotheses are defined as follows:        -  The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will          not reduce the RBC transfusions in patients undergoing surgeries associated with a          significant risk of bleeding.        -  The secondary hypothesis is that in patients monitored with continuous noninvasive          hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus,          there will be less frequent complications compared with patients who are not being          monitored with continuous noninvasive hemoglobin.   "
122185|NCT01686646|"     This study will investigate any improvement in alertness and performance based on cognitive     function and mood assessment in subjects suffering the common cold, when taking a novel     paracetamol and caffeine combination verses paracetamol alone.   "
122186|NCT01686633|"     This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study     with three active comparators in subjects with moderate to severe persistent asthma. The     study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and     a follow up contact period of one week. The total duration of the study is 17 weeks. 990     subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg     once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF     100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will     be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute     asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at     Weeks 2, 4, 8, and 12 (Visits 4 through 7).   "
122187|NCT01686620|"     The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to     insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1     diabetes.   "
122188|NCT01686607|"     This multicenter observational cohort study proposes to establish the risks of short and     long-term outcomes in users of parenteral micafungin and in users of other parenteral     antifungal agents from 2005 through 2012 with follow-up until 2017.   "
122189|NCT01686594|"     The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy     maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis     fungoides) patients.   "
122190|NCT01686581|"     This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®)     as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All     treatment decisions lie with the physician.   "
122191|NCT01686568|"     This study is being done to understand the effects of dietary omega-3 fats on insulin     sensitivity in adult men and women.   "
122192|NCT01686555|"     To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with     Systemic Lupus Erythematosus.   "
122193|NCT01686542|"     The study is designed as a randomized control trial. The purpose of this study is to observe     the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary     vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.   "
122194|NCT01686529|"     The aim of this study was to investigate the efficacy and safety of subconjunctival     bevacizumab application as an adjuvant therapy for primary pterygium.   "
122272|NCT01685502|"     The objective of this study is to assess the efficacy and safety under practical use of     Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1     year observation period.   "
122196|NCT01686503|"     The purpose of this study is to determine whether a lower dose of inactivated polio vaccine     (IPV) injected into the skin (intradermal administration) can work equally well or better     than the standard dose injected into the muscle (intramuscular administration). There are     more immune cells in the skin than in the muscle, and other vaccines have been shown to     require a lower dose when administered intradermally. The study is being done in participants     infected with HIV because HIV-infected people are known to respond less well to vaccines than     other groups, so it is particularly important to know if IPV might work better in     HIV-infected people if administered intradermally.      If it is possible to lower the dose of IPV by intradermal administration, this would make     inactivated polio vaccine more affordable in the developing countries where it is most needed   "
122197|NCT01686490|"     The purpose of this trial was to develop the initial sections of a video/DVD cassette that     provided guidance about mastering stressful situations for patients who had been informed     that they need an implantable cardioverter-defibrillator (AICD). We adapted the existing     LifeSkills video (which was already been shown effective in patients with heart diseases) to     the specific needs of patients with AICD's. Before its development, we held separate focus     groups with healthcare providers of AICD patients, pre-implantation patients, and     post-implantation patients. After the video/accompanying workbook was produced, we held an     additional focus group with patients who had received the video/workbook before receiving     their AICD.   "
122198|NCT01686477|"     Mother's Own Milk (MOM) is recommended for preterm babies. However, on average, mothers     giving birth preterm are able to provide less than half their baby's milk requirements.     Standard clinical practice is to make up any shortfall in MOM with either pasteurised Human     Donor Milk (HDM) or Preterm Formula (PTF). Which option is more beneficial to clinical     outcomes is unknown.      Pasteurisation reduces or destroys many biologically active components and HDM, unlike PTF,     is very variable in composition. Clinicians who use HDM do so primarily in the hope that     despite pasteurisation it will reduce bloodstream infection and necrotising enterocolitis, a     serious, devastating inflammatory disease characterised by bowel death and multisystem     failure. These are two of the most feared conditions in newborn medicine as described above.     Landmark nutritional trials in the early 1980's suggest positive effects of human milk on     insulin sensitivity, and other metabolic outcomes. Clinicians who prefer PTF believe it     benefits growth, including brain growth, and improves neurodevelopmental outcome.      In order to address this crucial question, central to preterm newborn care, a multicentre     United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve     sufficient power to evaluate the impact on the short-term outcomes necrotising enterocolitis     and bloodstream infection, and establish cohorts large enough to address long-term metabolic     (such as obesity, type 2 diabetes), cardiovascular (such as blood pressure) and developmental     outcomes. This pilot trial will evaluate the practicability and feasibility of such a large     multicentre UK randomised controlled trial. In addition to evaluating feasibility and to     ensure maximal use of resources allocated, this study will also assess outcomes that are     indicative of long term metabolic health.      Neonates born below 32 weeks gestational age will be randomised to receive fortified HDM,     unfortified HDM, or PTF to make up any shortfall in MOM until 35 weeks postmenstrual age with     a sample size of 22 in each group. The trial is designed to reflect current preterm feeding     practice. The trial will take place in neonatal units in London and parent consent obtained     within 48hr of birth. Permission will be sought for long term follow up, initially from     parents (later from children themselves). Outcomes will be body composition using magnetic     resonance imaging and other imaging techniques. This pilot study will specifically assess     feasibility by testing 1) provision of HDM by Human Milk Banks in London 2) acceptability to     parents and clinicians using feedback on trial design 3) recruitment to target and 4)     retrieval of clinical data for all recruited babies form the National Neonatal Database.   "
122199|NCT01686464|"     The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy,     called simultaneous Magnetic and Oxygen Treatment along Meridians and Collaterals (MOMC),     to treat Bell's Palsy.   "
122200|NCT01686451|"     Both XueZhiKang and Statins are cholesterol-lowering medications that are often prescribed     for individuals with high cholesterol and who are at risk for cardiovascular disease (CVD).     Several studies, including one randomized, double-blind, placebo-controlled clinical trial,     have suggested that the use of statins is more frequently associated with fatigue. And     XueZhiKang may be not. The purpose of this study is to compare the effect of these two     medications on fatigue in persons who are at moderate to low CVD risk based on the risk     estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis     Society) guidelines (2011) for the management of dyslipidemias.   "
122201|NCT01686438|"     Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD).     Treatment of insomnia with a specialized type of psychotherapy has been shown to be more     effective than treatment with medications. Unfortunately, few psychologists are trained to     provide this treatment, limiting Veterans' access to care, especially those Veterans in     remote and rural areas. This project will evaluate the ability to deliver this psychotherapy     to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic     insomnia will receive the psychotherapy treatment either by meeting in-person with the     psychologist or by the psychologist delivering the treatment by video teleconferencing.     Finding that video teleconferencing is a cost effective way to deliver this treatment could     add an important new component to the care of Veterans with PTSD that provides an alternative     to medications.   "
122202|NCT01686425|"     Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated     intrahepatic bile ducts will be recruited from the department of Gastroenterology and     Hepatology at the University Hospital of Leuven.      This population will have failed ERCP or will be considered when ERCP is not possible due to     altered surgical anatomy.      Patients will be randomized to either PTC or EUS guided biliary drainage   "
122203|NCT01686412|"     This is an exploratory study, national, unicentric, double-blind, to be conducted at the     Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect possible     autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy (EEFLE)     in healthy subjects and in patients with advanced hepatocellular carcinoma or in patients     with advanced breast carcinoma. Autonomic responses have been described in patients with     cancer during the exposure of EEFLE. This autonomic response, or biofeedback, due to exposure     to EEFLE seems to be associated with a specific set of modulation frequencies when applied to     patients with malignancies. Moreover, healthy individuals exposed to modulated EEFLE a     specific set of frequency do not appear to autonomic response. Biofeedback is defined by a     change in amplitude of the radial pulse during exposure to EEFLE, modulated according to a     set of specific frequencies. This phenomenon is not yet fully elucidated. In exploratory     survey of one patient was observed a change of the pressure pulse immediately after the start     of and during exposure to EEFLE, modulated according to a set of specific frequencies     recorded by digital photoplethysmography. This study aims to evaluate an autonomic response     in individuals exposed in a single moment, by electromagnetic fields. This study does not     intend to study a diagnostic or therapeutic procedure. For this reason, evolutive clinical     data will not be considered during and after the study.   "
122204|NCT01686399|"     The aim of this protocol is to use a multidisciplinary approach to convey nutrition and     activity messages to randomly selected Hadassah Medical Center employees. The intervention     will be for one academic year and include frontal talks, email and internet focus group     interactions, public demonstrations and a focused intervention within the hospital kitchen.      The outcomes are specific parameters of dietary modifications, degree of physical activity     and health related perspectives. Outcomes will be recorded at baseline and by the end of the     intervention ( one year).   "
122205|NCT01686386|"     This is an open Label, Phase I/II, multicenter study. In the first phase it defines the     maximum tolerated dose (MTD) of Bendamustine (B) given in combination with Lenalidomide (L)     and low-dose Dexamethasone (d) and in the second phase it evaluates the antitumour activity     of Bendamustine, Lenalidomide and Low-dose Dexamethasone (BdL) given in combination, in     relapsed multiple myeloma patients.   "
122206|NCT01686373|"     The purpose of this study is to assess the changes in language processing of patients with     chronic, post-stroke aphasia following the application of brain stimulation. The brain     stimulation the investigators administer is called transcranial direct current stimulation     (tDCS). It involves passing a weak electrical current through the brain between two     electrodes in the form of damp sponges. One sponge will be placed over a specified area on     the damaged left hemisphere, while the other sponge will be placed on the right scalp.     Computer-controlled speech-language treatment will be administered during the application of     tDCS.   "
122210|NCT01686321|"     Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's     lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies     have investigated the role of bendamustine in the treatment algorithm. The aim of the current     B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of     bendamustine and subcutaneous rituximab in old patients or in elderly patients with high     comorbidity who do not qualify for a CHOP like treatment. The results of this study will form     the basis of a larger, prospective randomized phase III trial.   "
122211|NCT01686308|"     Cataract is globally the most common cause of blindness and in Denmark the operation with -     50.000 treatments per year - is the most common eye operation. The cause of cataract is     growth and denaturation of the lens proteins. This leads to an increased absorption of blue     light and increased light scatter. This may affect newly discovered cells in the retina that     are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is     not synchronized with the external day and night a phase-shift occurs. Most people know of     this discomfort as jet-lag, but the consequences may be much more severe such as heighten     risk of cancer and cardiovascular disease.      The goal of this project is to study how the circadian regulating cells of the retina is     affected by cataract and by the operation. Cataract patients are studied before and after the     operation with questionnaires, hormone and activity measurements and with a specialized pupil     measurement that measures the indirect response of the circadian regulating cells to blue     light.      Results from this study aim to shed light on the regulatory mechanisms of the eye on the     circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular     lens is evaluated. This may have impact on clinical practise especially with regard to choice     of intraocular lens and widened indications for cataract surgery.   "
122212|NCT01686295|"     The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation     System when used as directed in promoting hair growth in men and women with androgenetic     alopecia   "
122213|NCT01686282|"     Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans     have been more concerned about their blood cholesterol levels and dietary cholesterol intakes     rather than their overall cardiovascular health risk factors leading to CVD such as     hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and     physical activity. Statistics show that approximately 91% of individuals with CVD have     vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to     increased arterial stiffness.      The investigators long-term goal is to provide feasible and effective dietary ways for pre-     and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve     vascular function and thereby reducing their cardiovascular risk and enhancing the quality of     life. Blueberries are a rich source of phenolic compounds and these compounds may play an     important role in promoting cardiovascular health. Considering the strong possibility that     phytochemicals present in blueberry work additively or synergistically, it would be ideal to     investigate the cardioprotective effects of blueberry as a whole. The investigators overall     objective to bring forth evidence that blueberry consumption will reduce BP and     cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and     autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The     investigators hypothesize that blueberry supplementation will improve vascular function and     will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this     study will provide a foundation for disseminating feasible, safe approaches for preventing     and combating hypertension at its early stage which does not require drug therapy.   "
122214|NCT01686269|"     Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has     an impact on multiple and diverse disciplines, including cardiology (coronary restenosis),     cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene [PTFE] graft     failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and     transplant medicine (chronic allograft rejection in hearts and kidneys). [1] In marked     contrast to the deleterious effects of smooth muscle progenitor cells on neointimal     hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an     important role in vascular repair and in the inhibition of neointimal hyperplasia. [2]     Endothelial progenitor cells (EPCs) circulate in adult peripheral blood and contribute to     neovascularization. Satoshi et al. have demonstrated that lineage-committed EPCs and     CD34-positive mononuclear cells, their putative precursors, are mobilized during an acute     ischemic event in humans. [3] Reduced levels of circulating EPCs independently predict     atherosclerotic disease progression, thus supporting an important role for endogenous     vascular repair to modulate the clinical course of coronary artery disease. [4] These     observations prompt the hypothesis that circulating EPCs may provide an endogenous repair     mechanism to counteract surgery-induced endothelial cell injury and to replace dysfunctional     endothelium perioperatively. Therefore, the investigators examined whether levels of     circulating EPCs correlate with time course and outcomes of coronary artery bypass surgery to     establish a clinical role of endogenous endothelial repair mediated by circulating EPCs.   "
122215|NCT01686256|"     A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium     Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.      Phase I - The proposed indication for FolateScan is disease or pathological assessment of     ovarian or endometrial masses.   "
122216|NCT01686243|"     The aim of this study is to demonstrate the feasibility of a new technique using real time     ultrasound guided paramedian approach to the epidural space. This approach will use     transverse view of the spine utilizing curvilinear low frequency ultrasound probe Sonosite S     nerve and echogenic 17G touhy needles  Pajunk TouhySono      The investigators believe that this new technique is helpful to get the best anatomic     landmark for epidural catheter placement using the real-time ultrasound.      Measurable outcomes:        -  Block performance time.        -  Block success rate.        -  Needle Depth to epidural space      Block success rate will be measured as the rate of cases that will have succesful insertion     of the epidural catheter using ultrasound guidance and the case is done completely under     epidural anesthesia.      All cases that will be converted to general anesthesia will be counted unsuccessful.      Other measurable outcome data that will be collected will include needle depth to the     epidural space, and ultrasound measured depth to the lamina   "
122219|NCT01686204|"     The main objective of this work is to conduct a clinical trial in obese and non-obese     individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health     and reduce chronic inflammation. Our central hypothesis is that short and long-term     consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese     individuals by improving intestinal barrier function.   "
122220|NCT01686191|"     Kidney disease is a common problem after heart transplantation. It may be caused by     anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some     people develop kidney problems after a heart transplant, but other people do not, is not     fully known. This study plans to learn more about the relationship between a person's genetic     make-up (DNA) and the risk of kidney problems after a heart transplant. The long-term goal of     this research is to identify genetic variations that may help predict the development of     kidney problems after heart transplantation.   "
122221|NCT01686178|"     The goal of the study is to implement and evaluate interventions to decrease smoking among     young adults attending bars and nightclubs. It is believed that the proportion of young adult     current smokers during and after the intervention will be significantly less than the     proportion of young adult smokers before the intervention in each of the study cities.   "
122222|NCT01686165|"     This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in     combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on     patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory     suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either     death of the cancer cells or prevention of their growth. In human studies with a small number     of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor     growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and     this may result in the disappearance of the tumor (remission)   "
122223|NCT01686152|"     To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and     Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic     keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy     of each of the two active treatments is superior to that of the Vehicle cream.   "
122224|NCT01686139|"     Diabetes Mellitus (DM) can be regarded as one of the epidemics of the western world.      DM contributes to severe morbidity and mortality due to damage in the target organs     (neuropathy, vasculopathy, nephropathy, retinopathy).      It affects the quality of life of the patients because of increased rate of blindness, IHD,     stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic     Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic patients     due to neurological damage and / or different levels of Peripheral Vascular Disease (PVD).     Diabetic foot complications are the most common cause of lower extremity amputations in the     industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in diabetic     patients.      Between 15% - 25% of the foot ulcers will lead to lower limb amputations.      It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many     diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and     critical limb ischemia.      Stem cells can be obtained from either the patient (autologous) or non-related healthy donors     (allogeneic).      The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow     Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg     wounds of diabetic patients.   "
122225|NCT01686126|"     Currently the standard treatment for early stage endometrial cancer or endometrial     hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and     removal of both ovaries. While highly effective, this surgery carries significant side     effects for:        -  young women who still wish to have children and would lose fertility; and        -  women with one or more disorders (or diseases) in addition to the early stage          endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are          at risk for surgical complications making surgery unsafe.      This study will access a new approach to the treatment of endometrial cancer to spare women     of having to undergo major surgery that may be unwanted or unnecessary.      Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent     thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement     therapy (HRT). However it is not approved to treat early stage endometrial cancer or     endometrial hyperplasia with atypia. This research project will test to see if Mirena is an     effective treatment for early stage endometrial cancer and endometrial hyperplasia with     atypia.      Metformin is approved in Australia to treat Diabetes. However it is not approved to treat     early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an     experimental treatment for early stage endometrial cancer and endometrial hyperplasia with     atypia. This means that it must be tested to see if it is an effective treatment for early     stage endometrial cancer and endometrial hyperplasia with atypia.      Weight loss interventions are feasible and safe, and already being implemented by     gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight     induces a large biological effect (for example reduces incidence of diabetes by 58%, and     hypertension by 26%).   "
122226|NCT01686113|"     This study will examine whether or not short, daily exposures change a person's ability to     detect free fatty acids in a solution by its taste. Repeated exposure should improve a     person's ability to detect free fatty acids.   "
122421|NCT01683682|"     To investigate the maximum tolerated dose of BIBF 1120 and safety in escalating doses     administered with Vinorelbine i.v. and Carboplatin i.v. in elderly patients with advanced     Non-Small Lung Cancer (Stage IV).   "
122227|NCT01686100|"     Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients     with coronary artery disease. This is done by using alternative blood vessels (grafts) to     bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where     surrounding tissue is removed, this may damage the vessel and influence its patency.      The no-touch technique was developed by Professor Domingos Souza at the Department of     Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes     taking out the vein with its surrounding tissue and by this way the vessel is less damaged.     The first two follow ups have shown that no-touch grafts had better patency than     conventionally extracted graft at 18 months and 8.5 years.      This long term follow up is a continuation of the randomized trial started in 1993 where the     patency and incidence of stenoses in the no touch and conventional vein grafts has been     studied.   "
122228|NCT01686087|"     The goal of this study is to understand whether patients with obsessive-compulsive disorder     (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral     therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if     they first do well with EX/RP.   "
122310|NCT01685008|"     This is an open-label, multicentre study to characterize the safety and preliminary efficacy     of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory     non-Hodgkin´s lymphoma (NHL) who have received at least 1 prior therapy containing rituximab     (at least once).   "
122229|NCT01686074|"     This project is a comprehensive study, with main focus on motor control, comparing patients     with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome     (FMS). Focus of the present project will be on detailed movement analysis in a movement     laboratory and involve functional tasks such as walking and standing. Investigations will     also comprise muscle activity, reaction time and fine motor control.   "
122230|NCT01686061|"     The purpose of this survey is to collect detailed information on patients treated for     blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including     how often they are treated with botulinum toxin, how long their treatment lasts, how     satisfied they are with their treatment, and if there is any improvement in their symptoms     with the treatment.   "
122231|NCT01686048|"     Ambrosia is known for its allergenicity in the USA causing hay fever and asthma. Israel has     always been considered clean of Ambrosia but over the past years growth of Ambrosia plants     has been detected in several locations in Israel.      In the proposed study, patients referred for routine allergic evaluation will also be skin     tested with Ambrosia allergens, in addition to their regular prick skin tests with all other     airborne allergens.   "
122232|NCT01686022|"     Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor     or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of     grass or weed are different in various part of the world. The allergens from grass and weed     has never been studied in Thailand. This study will find the major allergen from Bermuda     grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In     addition, the investigators will study about the cross-reactivity among these group of     allergen.   "
122233|NCT01686009|"     The provision of analgesia to patients in pain is a fundamental necessity of emergency     department practice and is usually accomplished using IV opioids. However, significant     barriers exist to the provision of timely analgesia by the IV route.      The use of the IN route for medication delivery provides an efficient and relatively painless     mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and     to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring     that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid,     easy-administered and well-tolerated method for providing analgesia in the ED setting.   "
122234|NCT01685996|"     Randomized trial to evaluate whether zonisamide can enhance varenicline-induced smoking     cessation.   "
122235|NCT01685983|"     The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral     abiraterone acetate and oral prednisolone in men with metastatic-castration resistant     prostate cancer (mCRPC) and with disease progression following treatment with a     docetaxel-containing chemotherapy.   "
122236|NCT01685970|"     Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel     preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance     patient tolerability and have similar bowel cleansing efficacy compared to standard method     using high volume split-dose PEG.      The investigators aimed to evaluate the efficacy and tolerability of bowel preparation     protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L)     split-dose for afternoon colonoscopy.   "
122237|NCT01685957|"     Recent decades have shown an alarming increase in obesity. Obesity is associated with high     costs for both the individual and for society. It is therefore important to prevent and treat     obesity. The investigators believe that if you add a self-help weightloss book and teach     cooking skills to a standard dietary treatment, then it will result in greater weight loss     than with dietary treatment alone. However, this has not yet been studied. Since it will     require more resources, it is important to investigate whether it also works better before     changing the current treatment.      Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and     cooking classes are more effective than dietary treatment alone in changes in body weight and     body composition in obese persons over a period of 12 months. There is no difference if the     intervention are based on the national dietary guidelines or a relative low-gi and     high-protein diet.      Secondary to investigate the impact the interventions have; on diet quality and quantity, on     markers of metabolic syndrome and on how many subjects complete the study.   "
122238|NCT01685944|"     This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body     fat and body weight in subjects with BMI 25-30 kg/m2.   "
122239|NCT01685931|"     The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly     dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated     by oral antipsychotics and with acute symptom of schizophrenia.   "
122240|NCT01685918|"     Study objectives        1. Comparison of drug persistency rates between elderly RA patients and young RA patients          with biological DMARDs        2. Analysis of discontinuation reasons & influencing factors of drug discontinuation in          elderly RA patients and young RA patients        3. Comparison of the occurrence of adverse events & treatment outcomes between elderly RA          patients and young RA patients   "
122463|NCT01683123|"     Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine     in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.   "
122241|NCT01685905|"     The purposes of this study        1. to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G),          and determine the level of agreement between two tests in patients with rheumatic          diseases        2. to evaluate the difference in the occurrence of active TB in patients who receive both          QFT-G and TST compared with those who receive only TST for detecting of Latent          tuberculosis infection(LTBI) who are candidates of TNF inhibitors.   "
122242|NCT01685892|"     This multi-center, open-label, dose-finding study will evaluate the safety and     pharmacokinetics of venetoclax (GDC-0199; ABT-199) administered in combination with     obinutuzumab to participants with relapsed/refractory or previously untreated chronic     lymphocytic leukemia (CLL). The study is comprised of two stages for each participant     population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will     explore multiple doses of venetoclax to be used in combination with a fixed dose of     obinutuzumab. The dose-finding stage will also explore two schedules for drug administration,     Schedule A (venetoclax introduced before obinutuzumab) and Schedule B (venetoclax introduced     after obinutuzumab).   "
122243|NCT01685879|"     Certain types of rice have more dietary fiber than others. This type of rice is known a high     amylose rice. This study hypothesizes that high-amylose rice, will decrease blood glucose     and insulin responses after consumption compared to conventional rice in healthy adults, ages     18-40. Eighteen healthy men and women will participate in this study. This study will     determine how high blood glucose and insulin values rise after eating a portion of rice. This     study will also evaluate hunger ratings after consuming rice. The results of this study will     help researchers better understand how diet can influence diabetes management.   "
122244|NCT01685866|"     Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral     veins in children having forecasted difficult venous access and could facilitate the venous     access.The main goal is to reduce the time necessary to get a venous access during the     inhalation anesthesia induction.   "
122245|NCT01685853|"     The present study is intended to evaluate the effectiveness, tolerability, compliance, and     feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L     Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of     colonoscopy, vs the standard 4L split PEG solution.   "
122246|NCT01685840|"     The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy     compared with usual care in high risk patients with left ventricular systolic dysfunction.   "
122247|NCT01685827|"     This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral     treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared     to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not     inferior to NECT treatment.   "
122248|NCT01685814|"     The investigators propose this study utilizing Lenalidomide, Adriamycin, Dexamethasone (RAD)     as comparator arm for Lenalidomide, Bortezomib, Dexamethasone (VRD) with the latter being     considered a novel standard as an induction protocol, since response in general occurs     early after starting treatment we decided to choose three cycles of either induction regimen.      Together with the novel compounds, tandem high-dose melphalan is still the standard of     care; it seems desirable to re-address the question of the number of transplant (single vs.     double high-dose melphalan) procedures required in the context of triplet-induction protocols     utilizing at least one of the novel compounds.      Thus, the question to be asked in the current protocol is whether immediate lenalidomide     maintenance (i.e. following one cycle of high-dose therapy) as an investigational agent will     result in identical progression free survival (PFS) when compared to tandem high-dose     melphalan with deferred maintenance therapy.      Despite induction with novel compounds, approximately 25 - 40% of patients will be in less     than very good partial response. Very recently, achievement of less than VGPR was confirmed     to negatively impact on both PFS as well as overall survival (OS). Therefore, allogeneic stem     cell transplantation is considered the standard of care in patients with suboptimal response     to a first autograft.      In the current protocol, the standard for favourable responders (tandem-autologous     transplant) is combined with 3 years of lenalidomide maintenance. This approach will be     investigated for patients with less than VGPR following a first autotransplant and compared     to the current standard of intensification in poor responders (allogeneic transplantation).   "
122249|NCT01685801|"     This study is a multiple within participant crossover study to evaluate the effect of     ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF)     who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator     (CFTR) function.   "
122250|NCT01685788|"     The overall aim of the project is to gain insight in sensory deficits and recovery patterns     in the upper limb post stroke and its association with brain lesion localisation.     Furthermore, the investigators will identify associations of deficits in sensory modalities     with upper limb impairments, activities and participation at different time points after     stroke. Identification of the sensory deficits, along with further insights in their relation     with objective neurophysiological and neuroanatomical measures will contribute to the     amelioration of goal-setting for the rehabilitation of upper extremity function after stroke.     These functions are indispensable during several daily activities as well in different sports     and leisure activities. This project is an important step towards a better delineating of     treatment interventions for the upper limb and to a better guiding of individual needs for     post-stroke treatment in the future.   "
122251|NCT01685775|"     Laparoscopic surgery has become the golden standard for the removal of the gallbladder.     Recently, developments have been made so that operations can be performed through a natural     orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study     compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation     using 2-3mm instruments in female patients. It also examines the benefits and disadvantages     related to postoperative pain, cosmetic aspects, and potential physiological alterations to     the transvaginal approach that affect sexual intercourse.   "
122252|NCT01685762|"     The purpose of this study is to see if metformin will be effective in making endometrial     hyperplasia without atypia better by returning the tissue to a normal state.   "
122464|NCT01683110|"     The objective of this study is to provide access to cabozantinib for eligible subjects with     medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by     the FDA and commercial availability of cabozantinib.   "
122281|NCT01685385|"     Difficulty in breathing or increased rate of breathing are common causes of admission to     intensive care unit. This may be due to heart failure, or other causes such as infection in     the lungs. Treating doctors usually perform Chest X-ray, ECG, and other tests to know if     breathlessness is due to heart failure or other cause. Doctors also give medicines to treat     heart failure, or other conditions of the lungs based on the symptoms and investigation     results. BNP is released by heart which is not functioning well. However BNP levels are also     high in case of severe infection.Hence there is equipoise in utility of BNP measurements     among critically ill patients, and it is not a current standard of care. The current cost of     this test (about 1000 rupees per measurement) is high, and hence its utility needs to be     carefully examined before a widespread use. The investigators intend to test the hypothesize     that that on-admission BNP measurements, help clinicians identify CHF early, which may modify     therapeutic decisions, and improve outcomes. The current study is designed with an objective     to determine if on-admission BNP value and availability of its test results to treating     physicians will reduce in-hospital, and 30-day mortality and in-hospital morbidity.   "
122253|NCT01685749|"     Stingray injuries can be a hazard shared by many types of beachgoers. Stingrays often lie in     the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword,     resulting in a barbed stinger injecting venom into the victim. Little exists in the current     literature on the natural history of stingray injuries. Most of the existing literature looks     at the incidence of stings, and to a certain extent the demographic of people who seek care.     To our knowledge no study has attempted to collect a more inclusive population of those     people who are stung and follow them prospectively to determine the incidence of medical     intervention, infection, etc.      This study aims to describe and quantify the natural history of stingray injuries and to     better understand their time course and medical requirements. The study setting will be Seal     Beach, which reports some of the greatest number of annual stingray injuries for any single     beach on the pacific coast. Participants will be identified by the Seal Beach lifeguards who     are believed to treat the majority of stingray injuries suffered at the beach. Eligible     persons will be consented for participation over the phone by research personnel. If enrolled     in the study they will receive a phone call by research personnel one week and one month     after the injury that will collect information about the symptoms they have experienced and     the medical interventions they have received, if any. This study is strictly observational in     nature and will not involve any interventions on the part of study personnel or alter the     manner in which or types of medical assessments or treatments.   "
122254|NCT01685736|"     Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements,     24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that     allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3     nights, 3 readings/night).   "
122255|NCT01685723|"     Background: Smoking cessation can largely improve cancer prognosis and quality of life among     cancer patients. However, few patients are aware of the importance to quit at the stage, or     they have difficulties to quit by self.      Aim: Test the effectiveness of a tailored and targeted smoking cessation intervention      Hypothesis: We hypothesize that improving risk communication could significantly increase the     quit rate of smoking cancer patients      Design: Cluster randomized controlled trial      Setting: Outpatient clinics in Queen Mary Hospital and Tuen Mun Hospital (Clinical Oncology     Departments)      Subject: Smoking patients who have diagnosed cancer with stable condition and treatments      Intervention: At baseline, intervention group receives:        1. health warnings of smoking from oncologists/nurses based on a special design leaflet;        2. a patient-centred counseling from nurse counselors with emphasis on risk perceptions of          smoking to cancer prognosis; and        3. examination of exhale CO level. They will receive up to 8 more telephone counseling          within 1 month by nurse counselor to reinforce the importance to quit and assist to          solve any barriers. Control group receive standard care and a generic self-help smoking          cessation booklet.      Outcome: Primary outcome is the self-reported 7-day point prevalence quit rate at 6-month     follow up. Secondary outcomes include:        1. change in risk perceptions of smoking;        2. change in the intention to quit;        3. validated 6-month quit rate;        4. patient's smoking reduction by at least 50% compared to baseline;        5. quit attempt(s);        6. change in health related quality of life; and        7. cancer recurrence rate at 6-month.      Significance: This study develops and validates practical smoking cessation interventions     targeted to cancer patients to improve their cancer prognosis and in long-term, increase     their survival time.   "
122256|NCT01685710|"     The aim of the study is to determine whether the application of a glyceryl trinitrate patch     (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that     they can be used.   "
122257|NCT01685697|"     Most premature babies have difficulty breathing at birth and need help (what we call     resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation     device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we     call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.      To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth     and nose. The clinical team tries to achieve a good seal between the face and the mask. A     problem of mask ventilation is that air can escape between the mask and the face (what we     call mask leak). Currently, two different types of facemasks (Laerdal mask or Fisher &     Paykel mask) are routinely used in the delivery room at The Royal Alexandra Hospital.      The purpose of this study is to find out if one facemask is leaking less between the face and     the mask.   "
122258|NCT01685684|"     The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared     with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic     low back pain requiring around-the-clock opioid analgesia for an extended period of time.   "
122259|NCT01685671|"     The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after     SC administration in health male volunteers   "
122260|NCT01685658|"     The main objective of this study was to demonstrate the non-inferiority of intravenous     paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency     ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30     minutes.   "
122261|NCT01685645|"     The pupillary pain-meter AlgiScan ® with integrated nociceptive stimulator is a portable,     battery-operated device which automatically measures, by means of an infrared camera, pupil     diameter. This is measured in response to noxious stimulation produced by a tetanus at a     frequency of 100 Hz for 5 seconds. Its intensity varies from 10 to 60 mA. The recording is     performed for a period of 13 seconds (3 seconds prior to stimulation, stimulation for 5     seconds, 5 seconds after the stimulation). An interval of 3 minutes is allowed between the     two measurements (right and left), which is significantly higher than the time necessary to     return to normal (about 20seconds).      The pupillary pain index (PPI) ranges from 0 to 10 and is a composite measure of the     pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device. Smaller     scores indicate increased analgesia.      The main objective of this study is to determine whether PPI index variation can determine a     prognostic threshold of analgesic efficacy of unilateral lower limb sensory nerve block     before incision. The measurements are performed after bilateral nociceptive stimulation     (blocked side versus non-blocked side) in patients under general anesthesia for major knee     surgery.   "
122273|NCT01685489|"     This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day     lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by     the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for     three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow     for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis     of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4     (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of     PSK/placebo lead-in and during cycles 1 and 4.   "
122262|NCT01685632|"     Intra Peritoneal Chemo Hyperthermia (IPCH) is a recently validated option for the treatment     of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program     demonstrated a significant improvement of the late stages (i.e. carcinomatosis) of the     disease. From a clinical point of view, within the first 24 hours after IPCH, patients     undergo a systemic inflammatory response syndrome, and therefore require to be monitored in     an intensive care unit. From a metabolic perspective, preliminary data have been shown a     significant anaerobic style disturbance of energetic metabolism, suggesting a deep cellular     energetic deficit throughout IPCH process.      Putative contradictory effects of IPCH, like the increase of chemotherapy-related cellular     toxicity due to heat and on the other hand the initiation of a stress protein response (heat     shock response) which helps to reduce the cell injuries, leads to conduct a research project     on the underlying mechanisms: consequences, in terms of patient's care and follow-up, are of     high relevance.      The primary goal is a multimodal assessment of the IPCH-related cell modifications: signaling     pathways, apoptosis and antitumoral immune response.      The assessment criteria include Heat shock protein expression (blood/cell ratio) compared to     baseline values, apoptosis and immune response before/after IPCH.      The scheduled sample size is 30 patients having an IPCH and 30 patients contraindicated per     surgery.   "
122263|NCT01685619|"     This clinical study will provide the study specimens (samples of bone marrow and blood) and     the clinical data for a pan-Canadian collaborative research project developed by the MDS/AML     Research Consortium. The goal of this project involves the evaluation and potential     validation of five novel prognostic tests for myelodysplasia (MDS) and/or acute myeloid     leukemia (AML), as well as an analysis of health economic and socio-ethical implications     related to the potential introduction of these tests into the clinical setting. The     over-arching goal is to improve the outcomes of patients with MDS and AML. The primary     hypothesis is that one or more of the laboratory tests being evaluated in conjunction with     this study, either alone or in combination with other laboratory tests (either established or     under investigation in this project), will have statistically significant prognostic value     either alone or in combination with established clinical risk factors.      The clinical study will involve the enrollment of 200 adults with AML and 200 adults with MDS     over a 2.5 year period. Participants will be followed on study for two years. Bone marrow and     blood specimens will be collected at diagnosis and at other time points as required for the     development of the five laboratory tests.      Participants will be assigned to treatment according to local institutional practice and will     be followed for up to 2 years. Health economic and quality of life questionnaires will be     administered at key time points. Data will be collected regarding participant     characteristics, diagnosis, disease features, treatment and clinical outcome.   "
122264|NCT01685606|"     The study of whether an infusion of blood cells called lymphocytes from a donor can stimulate     the immune system to fight your leukemia/lymphoma.   "
122265|NCT01685593|"     We conducted a controlled randomized trial examining the ability of the Mott abdominal     Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy     patients   "
122266|NCT01685580|"     Surgical treatment is the standard treatment for localized forms of lung cancer non-small     cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is     a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing     this procedure is a major public health issue. The non-invasive ventilation is a technique     commonly used postoperatively in acute respiratory distress and in the treatment of sleep     apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the     non-invasive ventilation achieved during 7 days minimum before the intervention could     significantly reduce postoperative complications in patients with an obstructive or     restrictive disorder, obesity or chronic heart failure.      The aim of the study is to demonstrate that the non-invasive ventilation in two pressure     levels achieved during at least 7 days before surgery lung resection (lobectomy or     segmentectomy) halved the pulmonary and cardiovascular postoperative patients with     obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.   "
122267|NCT01685567|"     The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™     Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection     during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also     facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or     diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA     approved carotid artery stent for the treatment of carotid artery disease.   "
122268|NCT01685554|"     The aim of our study was to evaluate the effect of different temperature regimens of     cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical     correction of acquired heart diseases.   "
122269|NCT01685541|"     The electronic medical record (EMR) offers a new method to provide patients with information     about their visits with a clinician. The EMR can generate personalized and patient specific     handouts at the end of the visit that can recap the topics covered during that visit. These     After Visit Summaries (AVS) can be automatically generated with information contained in the     patient's chart. The AVS has the potential to improve patient retention of information needed     for adherence to treatment plans, and follow-up instructions, and to facilitate information     transfer between healthcare settings. However, the content and formatting of the AVS to     optimize patients' information retention and satisfaction with the visit is not known. In     this study, we will develop and test in a randomized trial three different versions of an AVS     to determine the AVS content that maximizes patient satisfaction and retention of information     on the AVS,and adherence to physician instructions. The three versions of the AVS developed     from patient and physician input will be compared to a control condition which consists of     current practice in each setting.   "
122270|NCT01685528|"     The purpose of this study is to determine the feasibility and acceptability of providing     evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression     via telephone to rural Veterans receiving home-based primary care.   "
122271|NCT01685515|"     The purposes of this study are to observe if oral tetrahydrouridine and decitabine can     increase fetal hemoglobin levels and improve the symptoms of sickle cell disease, and to     monitor how patient's bodies react to oral tetrahydrouridine and decitabine.   "
122274|NCT01685476|"     In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing     and treating several conditions. Physicians having to manage cases of head trauma, stroke and     hydrocephalus need to assess the time course of ICP, yet they are often unwilling to     implement invasive monitoring beyond the acute stage, on account of high septic risks.     Standard techniques include direct ventricular manometry or measurement in the parenchyma     with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical methods     for gaining access to pressure changes is an important challenge. Fluctuations of ICP are     transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The     Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the     intra-labyrinthic pressure modify the functional activities of the outer hair cells in the     cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure,     which is detected as modifications in cochlear activities. Cochlear activities' recording are     non-invasive and technically simple. A probe is gently inserted into the outer portion of the     external ear canal.      The objective of this study is to assess prospectively the accuracy and the precision of a     new method for ICP monitoring (using cochlear activities) compared with invasive gold     standard CSF pressure monitoring.   "
122275|NCT01685463|"     Specific Primary Aims include:      Aim # 1. The investigators explore the feasibility of using the TMS to investigate the     cortical excitability and to inhibit meth cue craving in meth dependent population. The     investigators anticipate that meth elevates cortical excitability measured by motor     threshold, causes changes of cortical silent period, and RC. The investigators also     anticipate that paired pulse measures (short-interval intracortical inhibition,     short-interval intracortical facilitation and long-interval intracortical inhibition) will be     different from healthy control, which are more directly linked to glutamatergic cortical     facilitation and GABAergic inhibition, respectively.      Aim # 2. Given the change of the cortical excitability in meth users, the investigators will     use inhibiting TMS (1 Hz) over medial prefrontal cortex to study whether TMS can be used to     reduce cue craving. The investigators hypothesize that repetitive TMS reduce meth cue craving     in meth dependent population compared with sham rTMS.   "
122276|NCT01685450|"     The intracranial pressure (ICP), defined by the hydrostatic pressure of the cerebrospinal     fluid (CSF), is a key parameter for diagnosing and treating several neurosurgical diseases.     Continuous ICP monitoring has an important place in neuro-intensive care for patients with     severe head trauma and severe meningeal hemorrhage.      Until now the assessment of ICP requires invasive methods, with a pressure transducer either     within the ventricular CSF or within the brain parenchyma. The pressure sensor placement is     performed in a neurosurgery department. These invasive methods have also disadvantages:     highest risk of infections, catheter misplaced, and risk of bleeding. All these justify the     development of a non invasive method. The Biophysics Laboratory (School of Medicine of     Clermont-Ferrand) described that the intra-labyrinthic pressure (ILP) modify the functional     activities of the outer hair cells in the cochlea.      Cochlear activities' recording is non-invasive and technically simple. A probe is gently     inserted into the outer portion of the external ear canal.      Anatomical studies showed communication between the subarachnoid spaces and the perilymphatic     compartment by the cochlear aqueduct. Thereby, increases in ICP are transferred to increases     in intra-cochlear pressure, which is detected as modifications in cochlear activities.      CSF dynamic tests, as constant flow infusion test, are conducted in patients in the diagnosis     of the idiopathic adult hydrocephalus syndrome. Artificial CSF is infused through a lumbar     needle, into the CSF space at a constant rate, and the corresponding rise in ICP is     registered and analyzed.      The objective of this study is to assess prospectively the accuracy and the precision of a     new method for non invasive ICP measurement (using cochlear activities) compared with     invasive gold standard CSF pressure measurement during CSF dynamic tests.   "
122277|NCT01685437|"     This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in     subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21     days before the initial injection of study drug in the first treatment cycle. Enrollment will     include all subjects who meet the eligibility criteria and who received placebo and completed     one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804.   "
122278|NCT01685424|"     This postmarketing study was conducted to describe prescribing patterns for etoricoxib     (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded     in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA)     General Practice Research Database (GPRD).   "
122279|NCT01685411|"     This is a treatment guideline to allow routine clinical data to be collected and maintained     in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as     part of the historical database maintained by the department.   "
122280|NCT01685398|"     Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.     The characteristic natural history of this tumor is rapid growth in the first year of life     and follows by spontaneous involution. However, it may cause cosmetic unacceptable. Early     intervention in superficial IH may help to minimize the risk of residual aesthetic problems.     Topical timolol, a non selective beta-blocker, is an emerging treatment which has been     reported in efficacy and safety for the treatment of IH. However, the reported studies were     case-series or small study. This study is a prospective double-blind,randomized-controlled     study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in     superficial IH. The patient will be treated with topical timolol for at least 6 months and     instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the     entire lesion with a finger. Photographs of the lesion will be taken at the baseline and     every 1-month visit. Clinical evaluation of the treatment efficacy is carried out by 2     investigators independently to determine the change in lesion size and visual analogue scale     of the lesion color. The main outcome is to evaluate the efficacy of 0.5% timolol maleate     solution in treatment of infantile hemangioma compared to placebo.   "
122295|NCT01685203|"     The purpose of this study is to evaluate the safety and efficacy of co-administration of     ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as     ombitasvir) in adults with chronic hepatitis C virus infection.   "
122321|NCT01684865|"     This prospective observational study will evaluate the safety and efficacy of first-line     rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma.     Participants initiated on rituximab maintenance therapy according to the standard of care and     in line with the current summary of product characteristics will be followed for a maximum of     3 years or until disease progression occurs.   "
122372|NCT01684202|"     OPC-41061 will be administered to patients with volume overload associated with cancer, first     by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine     volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and     safety and to determine the effective initial and maintenance doses of OPC-41061.   "
122283|NCT01685359|"     The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau)     pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®     - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose.     The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic     and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau     Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing     plasma concentration of the drug and the reticulocyte count following a multiple intravenous     administration during 4 weeks of 100 IU/kg in healthy subjects.   "
122284|NCT01685346|"     This is a pilot study to test the hypothesis that biofeedback-mediated stress management     (BFSM) training can be used to reduce distress and enhance quality of life in patients with     non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant     physical symptoms, but even those who do not have physical symptoms have high levels of     anxiety and depression.   "
122285|NCT01685333|"     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects     following administration of single intravenous dose. The objective of this randomized,     crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of     the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced     by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count     following a single-dose intravenous administration of 100 IU/kg in healthy subjects.   "
122286|NCT01685320|"     Forces applied on soft upper tissues by different laryngoscope blades during direct     laryngoscopy and intubation are considered to be major stimuli to cause serious damages to     the patients. The aim of this study is to compare the force and pressure applied to soft     tissue in order to achieve the same glottis view comparing direct laryngoscopy and     videolaryngoscopy in vivo.   "
122287|NCT01685307|"     Few is known on meat protein digestibility in humans and the impact of cooking process, while     excessive intake of processed meat has been suggested to increase the risk of colorectal     cancer.      This study aims to measure in vivo in humans the real digestibility of beef meat proteins     depending 2 cooking processes, using ileal tubes and stable isotopes.   "
122288|NCT01685294|"     This study will examine the effects of a first-line treatment for major depressive disorder     (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.   "
122289|NCT01685281|"     study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI     (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with     PI-ADHD.      subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as     follows:        1. week 1:1400 mg, week 2:700 mg, week 3:placebo        2. week 1:700 mg,week 2: placebo,week 3:1400 mg        3. week 1: placebo, week2:1400 mg, week 3 700 mg      The study will consist of three periods: a screening period of up to one week, a 3-week     double-blind treatment period, and a one-week safety follow-up period.   "
122290|NCT01685268|"     A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with     Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with     abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same     doses of abiraterone and steroids they were receiving prior to study entry and will be     randomized to receive 1 of 2 different treatment regimens of AT13387 in combination with     abiraterone. Once the best regimen is established in Part A, based on safety and antitumor     activity, patients will be randomized to the selected treatment regimen and dose of AT13387     in combination with abiraterone or AT13387 alone in Part B (Phase 2).   "
122291|NCT01685255|"     This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360 versus     tamoxifen in biochemical recurrent only ovarian cancer patients following complete remission     with first-line chemotherapy.   "
122292|NCT01685242|"     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in     the conjunctival allergen challenge (CAC) model.   "
122293|NCT01685229|"     This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS)     patients treated with balloon sinus dilation (BSD) versus continued medical management.   "
122294|NCT01685216|"     Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme     glucocerebrosidase (GCB). Gaucher disease has been classified into 3 clinical subtypes based     on the presence or absence of neurological symptoms and the severity of these neurological     symptoms. Patients with type 2 Gaucher disease present with acute neurological deterioration,     and those with type 3 disease typically display a more sub acute neurological course. Type 1     Gaucher disease, the most common form accounting for more than 90% of all Gaucher disease     cases, does not involve the central nervous system.      The purpose of this clinical research study is to investigate the safety and effectiveness of     velaglucerase alfa in patients with type 3 Gaucher disease.   "
122296|NCT01685190|"     Prostate cancer is the most common male cancer in the UK with 35,000 cases diagnosed     annually. 35% of these are locally advanced disease. These patients have a high chance of     pelvic lymph node involvement and have relatively poor prostate cancer survival rates of     22.5% at 10 years.      One of the standard treatments for these patients is radiotherapy to the prostate. PIVOTAL is     a multi-centre phase II non-comparative randomised feasibility trial, in which patients with     a high chance of pelvic lymph node involvement are randomised between prostate radiotherapy     alone and prostate + pelvic radiotherapy.      Both groups will receive radiotherapy called Intensity Modulated Radiation Therapy (IMRT).     This is a relatively new method of shaping radiotherapy treatment beams which allows the     tumour to be treated more precisely, whilst avoiding more of the surrounding normal, healthy     tissues (particularly the rectum, bladder and bowel). Using IMRT, it is possible to deliver     higher doses of radiotherapy to the pelvis than with previous radiotherapy methods - this has     been tested in a single hospital, single group setting and levels of side effects (toxicity)     were acceptable.      PIVOTAL aims to find out whether toxicity levels at 18 weeks from the start of radiotherapy     remain acceptable when treatment is given in multiple cancer centres across the UK. It is     randomised to ensure unbiased collection of acute toxicity data and to provide information on     patients' willingness to participate in a randomised study. Should the phase II study be     successful, the investigators would develop a phase III trial to compare treatment     effectiveness (disease control).      Patients who enter PIVOTAL will be followed up for two years from the start of radiotherapy     and data relating to toxicity will be collected. They will also be asked to complete patient     related symptoms questionnaires. Data related to disease recurrence will then be collected     annually from patients' standard hospital visits.   "
122528|NCT01682161|"     The purpose of this study is to evaluate the change of medication satisfaction measured by     Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are     switched into paliperidone palmitate, either immediately or in a delayed mode.   "
122297|NCT01685177|"     Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a     modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is     performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up.     Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least     equally to standard duodenal switch as a second step after sleeve gastrectomy in the     super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal     bypass is simpler to perform, quicker and has less postoperative short, mid and long-term     complications.   "
122298|NCT01685164|"     As intrauterine contraception is an increasingly popular form of contraception the objective     of our study is to examine if uterine size or posture affects the insertion or use of     intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device     (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.   "
122299|NCT01685151|"     To evaluate the efficacy and safety of once a day ramelteon tablets for sublingual     administration (TAK-375SL) in the maintenance treatment of bipolar 1 disorder.   "
122300|NCT01685138|"     A single-arm, open-label, two-stage multicenter, phase II study. Patients will be     pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd will continue until     the patient experiences unacceptable toxicity that precludes further treatment, discontinues     treatment at the discretion of the investigator or patient, starts a new anticancer therapy     and/or dies. LDK378 may be continued beyond RECIST defined PD as assessed by the     investigator, if in the judgment of the investigator, there is evidence of clinical benefit.     Patients who discontinue the study medication in the absence of progression will continue to     be followed for tumor assessment until the time of PD as assessed by the investigator. Male     and female patients aged 18 or over with ALK-rearranged NSCLC will be screened for     eligibility. Patients must have received no prior crizotinib, and must be chemotherapy-naïve     or have been pretreated with cytotoxic chemotherapy (up to three prior lines)   "
122301|NCT01685125|"     This phase II trial studies how well giving abiraterone acetate and prednisone with or     without dasatinib works in treating patients with metastatic, hormone-resistant prostate     cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as     abiraterone acetate, may lessen the amount of androgens made by the body. Dasatinib may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not     yet known whether abiraterone acetate and prednisone is more effective than abiraterone     acetate, prednisone, and dasatinib in treating prostate cancer   "
122302|NCT01685112|"     Although few cases reported successful treatment of septic shock using extracorporeal     membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment     (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a     randomized study to allocate patients in such critical condition, we aimed to conduct a     retrospective observational study using propensity score matched analysis to compare the     survival of adults with septic shock treated by ECMO or conventional treatment.   "
122303|NCT01685099|"     1. To investigate the difference of PE inflammation/apoptosis-associated markers between TB          pleurisy and non-TB pleurisy        2. To investigate the difference of neutrophil apoptosis in exudative PE between TB          pleurisy and non-TB pleurisy        3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB          antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy        4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and          apoptosis pattern of PE neutrophil for tuberculous pleurisy   "
122304|NCT01685086|"     To follow-up the latent tuberculosis infection and evaluate the risk of developing active     tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis   "
122305|NCT01685073|"     The number of people seeking treatment for marijuana-related problems is on the rise, yet     there is no currently accepted medication proven to help them quit. Frequent marijuana users     have reported that they have trouble sleeping when they try to quit, and that the loss of     sleep can lead to relapse. This research is designed to measure the severity of sleep     problems in people as they are trying to quit heavy use of marijuana, and to investigate     whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to     stop using marijuana.   "
122306|NCT01685060|"     A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd     continued until the patient experienced unacceptable toxicity that precluded further     treatment, discontinued treatment at the discretion of the investigator or patient, started a     new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined     progressive disease (PD) as assessed by the investigator if, in the judgment of the     investigator, there was evidence of clinical benefit. In these patients tumor assessment     would continue as per the schedule of assessments until treatment with LDK378 was permanently     discontinued. Patients who discontinued the study medication in the absence of progression     continued to be followed for tumor assessment until the time of PD as assessed by the     investigator   "
122307|NCT01685047|"     The purpose of this investigation is to determine the prevalence of device-recorded ST     segment changes occurring before appropriate ICD therapies (ATP or Shock) and to define their     temporal relationship to ventricular arrhythmias.   "
122308|NCT01685034|"     Eosinophilic esophagitis (EoE) is a disease that has increased in incidence over the past     decade that affects males predominantly, and in adults, is characterized by heartburn,     dysphagia, strictures and food impactions. These symptoms may require emergent endoscopic     removal of foods and esophageal dilations due to remodeling causing significant impairment in     quality of life. Treatment options are limited and often not well tolerated or effective.     There is poor understanding of the natural history and long term prognosis. It has been     associated with allergic sensitization; a high percentage of affected individuals having     associated atopy and current literature demonstrates a seasonal distribution of incidence and     severity of symptoms. Allergy immunotherapy (AIT) is a well established and effective     treatment for allergic rhinitis and asthma which can induce tolerance to environmental     allergens.      Given the efficacy of AIT and the association of aeroallergen sensitization and even seasonal     variation of EoE symptoms, we hypothesized that AIT may be a treatment option for patients     with EoE.   "
122311|NCT01684995|"     The goal of this study is to test, in combination with the nicotine patch, the incremental     efficacy of a motivationally tailored behavioral intervention over a minimal intervention.     The interventions will be delivered through primary care medical clinics. The defined     population comprises low income, less educated smokers who will vary in their level of     motivation to quit smoking. Patients will be randomly assigned within clinics to one of two     interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and     (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored     motivational intervention, a behavioral skills counseling session for smoking cessation.   "
122312|NCT01684982|"     Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in     patient with acute myocardial infarction treated with primary percutaneous coronary     intervention (PCI)   "
122313|NCT01684969|"     This will be a blinded study to compare the absorption of topical haloperidol with placebo   "
122314|NCT01684956|"     The investigators are doing this research study to find out if the type of needle used to     administer them affects the speed with which insulin and glucagon get into the blood. The     investigators will compare a traditional insulin needle to an injection device, called the     MicronJet, that uses microneedles to deliver medication into the top layer of your skin.   "
122315|NCT01684943|"     The investigators are doing this research study to compare the pharmacokinetics (rate of     absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine     (Apidra) within individual subjects.      Additionally, the investigators will perform a preliminary feasibility evaluation of a     minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK     parameters in human subjects.   "
122316|NCT01684930|"     The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high     nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised     exercise training at the limb ischemic threshold (SET) will produce a greater clinical     benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic     threshold (PET).   "
122317|NCT01684917|"     The overall objective of the research is to develop new methods for studying the link between     diet, health and disease.      The enquiry consists of two part. A metabolomic biomarker discovery study followed by a     randomised controlled trial of moderate dietary induced weight loss.      A cohort of moderately overweight men and women will undergo a metabolomic study follow by     randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week     period. This intervention will improve the volunteer's body composition and reduce their risk     of developing diabetes.      Extensive tests will be conducted before and after the dietary intervention using emerging     technologies with current state-of-the-art methods. These tests will monitor the numerous     physiological adaptations that have occurred on a gene, cell, organ and organismic level.      The study will, therefore, aim for a scientific breakthrough by developing a series of novel     biological markers that can accurately determine an individual's health status.   "
122318|NCT01684904|"     The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a     regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal     proton modality, followed by definitive surgery. In most combined-modality trials to date,     chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil.      In designing the regimen, the investigators attempt to improve on the standard     cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the     regimen. This agent has activity against advanced esophageal cancer and is also a potent     radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in     reduced toxicity of various combination regimens similar to that used by CROSS trial and     allows for easier administration in the outpatient setting.4 Third, for localized esophageal     cancer, dose distribution patterns achievable with proton beam could potentially offer     important clinical advantages relative to those achievable with x-rays (photons).19 Based on     this, the investigators believe that this study should be conducted with the radiation     modality that offers the best dosimetry achievable at our institution.   "
122319|NCT01684891|"     This is a single-center, open label, multiple dose study to investigate the pharmacokinetics     of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of     [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male     volunteers. The anticipated time of study treatment is 4 weeks.   "
122320|NCT01684878|"     This two-part, multicenter study will evaluate the safety, tolerability and efficacy of     pertuzumab in combination with standard chemotherapy in women with recurrent     platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in,     participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized,     double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in     combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).   "
122322|NCT01684852|"     This is a comparative, open label, parallel group, non interventional study to further     demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall     be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product     according to the instructions for use six times daily in both eyes over a period of 28 days.     Response to treatment is recorded at day 28.   "
122323|NCT01684839|"     Neuroma excision and digital nerve reconstruction remain the best option for the treatment of     Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional     nonvascularized nerve grafting is the primary option to bridge the defect. The investigators     hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital     nerve is better than conventional methods for reconstruction of the digital nerve defect     after painful neuroma resection.      This study reports treatment of painful digital neuroma using a pedicled nerve flap taken     from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the     patients had previous nerve injuries with or without nerve repair. The mechanisms of injury     include sharp cut, avulsion and crush. The defects were between the middle of the distal     phalanx and the palmar digital crease.   "
122360|NCT01684358|"     This unblinded, randomized controlled trial (RCT) among women to determine:      1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women who     receive a contraceptive implant immediately at baseline during three months of follow up     compared to women who receive the implant at the three month follow-up visit.   "
122324|NCT01684826|"     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose     significantly. This is realized by anatomy-specific optimization of the full acquisition     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and     shorter pulses are used, which are known to positively influence image quality . The final     effect on the clinical image quality is investigated in this study.   "
122325|NCT01684813|"     The purpose of this study is to determine if, in type 2 diabetic patients undergoing     treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading     dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of     75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at     24-36 hours of treatment.   "
122326|NCT01684800|"     The purpose of the study is to investigate the efficacy and safety of two different dose     levels of desmopressin orally disintegrating tablets against placebo for the treatment of     nocturia in adult women during 12 weeks treatment   "
122327|NCT01684787|"     In the current practice patients with normal levels of ALT were not treated. However, a     percentage of patients will present an advanced grade of fibrosis and cirrhosis.      Another reason to treat is the similar response to the treatment than elevated ALT patients     published recently in mono-infected patients.      The investigators have not data concerning the evolution and response to the treatment in     co-infected patients with normal ALT.      In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it     assumes a behavior similar between mono and co-infected patients and the results are     different.      In the case of normal ALT the investigators do not know if the natural history in co-infected     patients is similar than the mono-infected patients, and also the response of the treatment.      This study prospective and controls is the answer of this question. The main hypothesis is if     the response of treatment in co-infected patients is not inferior than mono-infected     patients.      The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin     in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE     (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning     genotype, gender and hospital.   "
122328|NCT01684774|"     The investigators will be comparing ultrasound-guided (USG) ankle block and anatomic     landmark-guided (ALG) ankle block to determine which of these procedures is better in     surgical anesthesia and in postoperative pain relief.   "
122329|NCT01684761|"     The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell     Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis     (SPMS).   "
122330|NCT01684748|"     Overweight and obesity, which afflicts ~65% of the U.S. population and more than 1 billion     people worldwide, increases the risk of developing hypertension. Activation of the renin     angiotensin system (RAS) is an important mechanism by which obesity leads to hypertension. In     addition to its vasoconstricting and sodium retaining actions, angiotensin II also has potent     pro-inflammatory actions including macrophage infiltration and expression of proinflammatory     cytokines in target tissues. Adipose tissue and skeletal muscle appear to be a key sites for     the generation of proinflammatory cytokines. Although angiotensin II receptor blockade     reduces inflammation in many tissues, the effects on adipose tissue and skeletal muscle in     humans are not clear. Importantly, the chronic low grade inflammatory state that accompanies     obesity complicates hypertension by contributing to insulin resistance and accelerating     cardiovascular disease. Therefore, the general aim of the present proposal will be to     determine the influence of angiotensin II receptor blockade on adipose tissue and skeletal     muscle inflammation and its relation to improvements in insulin sensitivity, if observed, in     obese hypertensive humans. To address these aims, 44 obese (BMI>30 kg/m2) hypertensive     (BP>140 systolic and/or 90 diastolic) individuals (age=50-65 years) will be randomized to     receive 8 weeks of either the angiotensin II receptor antagonist, olmesartan medoxomil, or no     treatment in a crossover manner. Subcutaneous adipose tissue and skeletal muscle biopsies     will be obtained and insulin sensitivity (intravenous glucose tolerance tests) will be     assessed at baseline and following 8 weeks of each intervention. A two week washout period     will separate the interventions.   "
122331|NCT01684735|"     Evaluation of the response to chemotherapy in breast cancer patients by the use of     Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy,     after one and 3 cycles of therapy and at the end of the therapy.   "
122332|NCT01684722|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study is being conducted among participants in VITAL with a history     of diabetes and will examine whether vitamin D or fish oil prevents the development and     progression of diabetic kidney disease.   "
122333|NCT01684709|"     This study compares the medical and psychological effects of telemonitoring plus intensified     self-management support to those of usual care alone for patients with poorly controlled type     2 diabetes mellitus (DM). If this intervention proves effective without increasing costs or     clinician burden, then its implementation could yield major public health benefits,     especially for vulnerable and underserved DM patients, and broader societal benefit may occur     through increased helping behavior and strengthened social ties.   "
122334|NCT01684696|"     Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is unique     because of racial disparity, persistent mortality rate, and social stigma. Lung cancer stigma     (LCS) and difficult patient-clinician communication may be an underlying factor in health     disparities in lung cancer. The purpose of this study is to PILOT test, in a diverse sample     of lung cancer patients the effectiveness of the mHealth Tool for Lung Cancer patients     (mHealthTLC), an interactive, immersive 3-dimensional iPad application that allows     individuals to experience first person virtual visits with their clinicians, to improve     patient-clinician communication, decrease LCS, and promote optimal self-management. The study     hypotheses are that patients who receive the mHealth TLC will improve their ability to     communicate effectively with their clinicians and will report decreased stigma related to     their lung cancer diagnosis compared to the attention control group.   "
122335|NCT01684683|"     Theophylline was well recommended in the treatment of chronic obstructive pulmonary disease     (COPD) and asthma. However, there is no supporting evidence for their efficacy in the     treatment of bronchiectasis. Our hypothesis is that theophylline will play a role in     bronchiectasis. Our purpose is to examine the efficacy and safety of 24 weeks treatment with     theophylline in subjects with non-cystic fibrosis bronchiectasis.   "
122336|NCT01684670|"     This research study is designed to investigate the feasibility and treatment effects of a     behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria.     The speech sessions will provide an intensive, articulation-based intervention focused on     increasing effort during speech production via use of clear speech. A single subject     multiple baselines across subjects design will be employed in a total of six subjects divided     into two groups of three. Changes in dependent measures will be determined by visual     inspection, effect size determination, and time series analysis. The study follows accepted     procedures in rehabilitation treatment and research and there are minimal foreseeable risks     associated with participation.   "
122337|NCT01684657|"     The purpose of this research study is to find out the potential benefits and safety of     asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.      It is hypothesized that individuals who are randomly assigned to asenapine will have an     improvement in speech as compared to a placebo.   "
122338|NCT01684644|"     The purpose of this study is to investigate the effectiveness of parent training in the     treatment of ADHD in young children (ages 3-7) referred to Danish child mental health     services. Medication is not recommended as first-line treatment for young children with ADHD.     Parent training is recommended, but has not been formally introduced or established in     Denmark. The study will investigate the effectiveness of a parent training programme     specifically developed to target ADHD symptoms in young children; The New Forest Parenting     Programme, against Treatment as Usual for children diagnosed with ADHD at two different child     mental health clinics in Denmark.   "
122339|NCT01684631|"     The objective is to evaluate the implant survival rate for patients implanted with a     PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the     treatment of a severe hip disease and true femoral cervical fracture.   "
122340|NCT01684618|"     -  Due to the increased risk of brain damage, continuous monitoring of the cerebral          oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to          detect induced changes in the cerebral regional saturation.        -  The purpose of the study is to investigate our hypothesis that a particular CPAP flow          pressure optimizes the regional cerebral oxygenation.   "
122341|NCT01684605|"     The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after     IV administration in health male volunteers   "
122342|NCT01684592|"     Smoking is a leading cause of death and other negative health outcomes. While a high     percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months     postpartum. We propose developing and pilot testing a phone-based postpartum continuing care     (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation,     reduce relapse, increase early re-intervention, and reduce infant exposure to environmental     tobacco smoke in the postpartum period.   "
122343|NCT01684579|"     Recent studies have shown that some behavioral factors such as physical activity and exercise     may improve quality of life and outcome in patients with breast cancer as well as decrease     body fat, increase lean mass and reduce cancer-promoting hormones. None of these studies have     been performed in African-American women with breast cancer. The medical field needs to     understand how exercise may benefit cancer patients, particularly African Americans, and how     to optimize these benefits to improve the quality of life, prognosis and survival.   "
122344|NCT01684566|"     To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral     mucositis in patients receiving conditioning treatment for hematopoietic stem cell     transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral     mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed     daily by the investigator over the 28-day study period.   "
122345|NCT01684553|"     It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and     lesser feelings of hunger and desire to eat and higher levels of fullness after the meal     compared to eating the same meal more quickly.   "
122346|NCT01684540|"     This is a comparative, open label, parallel group, non interventional study to further     demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition     the effectiveness and safety shall be compared to a Sinupret forte. The patient applies     Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use.     The observation takes place over a period of 14 days. Response to treatment is recorded at     day 7 and day 14 by the physician and in daily by the patient in a dairy.   "
134858|NCT01519661|"     This study assessed the long term safety data for the use of tobramycin inhalation powder in     patients suffering from cystic fibrosis who have a chronic pulmonary infection with     Pseudomonas aeruginosa.   "
122347|NCT01684527|"     The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence     the population of lung immature myeloid cells and dendritic cells in a way that will impair     their ability to invoke an effective immune response and lead to prolonged inflammation,     angiogenesis and scarring. This may lead in turn to disturbed lung function.      Our aim is to determine the presence and phenotype of immature myeloid cells present in     respiratory secretions of children with RSV bronchiolitis as compared to non-RSV     bronchiolitis and healthy controls.   "
122361|NCT01684345|"     The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of     active non-infectious intermediate, posterior, or pan- uveitis.   "
122362|NCT01684332|"     The aim of this study is to investigate the effects of an acute intake of three different     types of strawberry jam, differing in the carbohydrates and antioxidants content, on     postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in     healthy adults.   "
122375|NCT01684163|"     GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major     depressive disorder (depression) who have responded inadequately to another antidepressant     drug during the current episode. This trial will assess the effects of GLYX-13 on depression     when added to another antidepressant drug that the patient is already taking.   "
122348|NCT01684514|"     Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic structures     in vivo. The examination is carried out with a confocal laser endomicroscope, which is either     part of the endoscope (manufactured by Pentax) or probe based (manufactured by Cellvizio).     Hereby, all parts of the gastrointestinal (GI) tract can be examined. The method has     potential to replace conventional microscopy and the dynamic nature of the procedure allows     visualization of structures and cellular processes in almost real-time. This provides us with     a potentially new diagnostic tool with a promising future. To date only a few studies have     been published on inflammatory bowel disease (IBD) and in the literature high-quality     research is still lacking.      The project consists of a blinded prospective observation and methodology study including     inter- and intra-observation of patients with proctitis before and after initiation of local     treatment.      Hypothesis: CLE can be used to assess the degree and extend of acute and chronic inflammation     and treatment response in patients with ulcerative colitis and is a sensitive supplementary     to conventional diagnostics.   "
122349|NCT01684501|"     The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot     and evaluate if it provides a physiological generation of power at the ankle in transtibial     amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e.     robotic system).   "
122350|NCT01684488|"     The research will first examine data obtained from YRI participants to investigate effects of     the group sessions on psychosocial and functioning outcomes in youth.      In pursuit of this aim, this research will investigate the following hypothesis:     Participation in the Youth Readiness Intervention will reduce symptoms of internalizing,     externalizing, trauma-related symptoms, and improve prosocial skills and functioning among     war-affected 15-24 year olds in Sierra Leone.      The research also intends to examine whether youth enrolled in a psychosocial Youth     Readiness Intervention (YRI) and a complementary education program fare better than an     education-only control group, a psychosocial-only control group, and a waitlist control     group.      In pursuit of this second aim, this research will investigate the following hypothesis: A     combined psychosocial-education program is an effective paradigm for improving psychosocial,     functional, educational, and economic self-sufficiency outcomes among war-affected youth.   "
122351|NCT01684475|"     The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of     dopamine receptors and thereby reduce symptoms of Parkinson's Disease.   "
122352|NCT01684462|"     In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the     patients occurred within 12 hours of acute ischemic stroke.   "
122353|NCT01684449|"     The soft tissue sarcomas (STS) constitute an infrequent group of malignant neoplasms of     mesenchymal origin. In Spain, the approximate incidence is of 2 new cases per 100.000     inhabitants every year. In patients with metastatic STS, the average survival is very short,     approximately 12 months. The systemic treatment of the metastatic disease has had a very     limited development, with few satisfactory results. This facts reflect the urgent need to     identify new active agents for treatment of these patients.      The molecular pathway of the serine/threonine kinase mammalian target of rapamycin (mTOR)     plays a central role in the regulation of the proteins translation, cellular growth and     metabolism (Meric-Bernstam F et al. 2009). Currently, the mTOR pathway is considered a     relevant target for the development of anti-cancer drugs, as rapamycin. Preliminary results     of some clinical trials suggest that mTOR inhibitors could have some clinical activity for     different types of sarcoma, including STS (Chawla et al Proc.ASCO 2006; Schuetze et al.     Proc.ASCO 2006).      Gemcitabine is a chemotherapy antimetabolite agent with a broad antitumoral spectrum. The     activity of this drug to treat resistant sarcomas and its reduced toxicity make from     gemcitabine an adequate candidate for its study in combination with new drugs addressed to     molecular targets in the STS treatment.      Pre-clinical studies suggest that mTOR inhibitors could have a potential synergistic or     additive effect with some chemotherapy agents. The combination of rapamycin and gemcitabine     seems to be a reasonable strategy to explore for the STS treatment.   "
122354|NCT01684436|"     This study will access changes in tear protein levels and symptoms of dry eye following     insertion of a punctal plug.   "
122355|NCT01684423|"     The purpose of this study is to find out whether rivaroxaban is safe to use in children and     how long it stays in the body. There will also be a check for bleeding and worsening of blood     clots.   "
122356|NCT01684410|"     This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the     safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day     for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment     duration in this study was intended to provide multi-dose safety information prior to     proceeding to longer durations of exposure.   "
122357|NCT01684397|"     This phase I/II trial studies the side effects and best dose of pazopanib hydrochloride and     bevacizumab and to see how well they work in treating patients with previously untreated     kidney cancer that has spread to other places in the body (metastatic). Pazopanib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking     blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can prevent tumor growth     by blocking the ability of tumor cells to grow and spread. Giving pazopanib hydrochloride     together with bevacizumab may kill more tumor cells.   "
122358|NCT01684384|"     In this study the consequences of exacerbations will be visualized by high resolution     computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity     (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based     airway dimensions and computational fluid dynamic (CFD) -based resistance values will be     correlated with changes in patient reported outcomes (PROs) and lung function tests recorded     at the same time.   "
122359|NCT01684371|"     The treatment of osteoarthritis, a disease that eventually affects the majority of the older     population, involves the alleviation of symptoms such as pain and stiffness, and the     reduction of inflammation. A double-blind, placebo-controlled, crossover study will be     performed to examine the effect of topical application of Elmore Oil, a herbal remedy     (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been     reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.   "
122363|NCT01684319|"     Various digestive manifestations are common in infants less than 6 months and have a     significant impact on morbidity and quality of life of the family. In a prospective study on     more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of     these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%),     constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate,     and their cause is often difficult to determine. Frequently, the pediatrician will exclude     cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked.     This measure causes significant additional costs through the use of extensively hydrolyzed     milk specifically for children and involves an elimination diet of all foods containing cow's     milk sometimes for several years. This can negatively influence the growth of the child.      If the involvement of milk in these pathologies is suggested by some early studies (35% for     colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current     state of knowledge if these gastrointestinal symptoms are actually due to an allergy to     milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy.     However, various tests have proven their effectiveness in the investigation of non     IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.   "
122364|NCT01684306|"     There is growing debate on the use of drugs that can promote cognitive enhancement.     Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have     important side effects and may induce addiction. In our study, we will investigate the use of     modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears     to have less side effects compared to amphetamine-like drugs and we will analyzed whether the     drug can influence cognitive performances and the brain resting state network activity of     healthy young subjects.   "
122365|NCT01684293|"     This study integrates a model of occupational-therapy based cognitive rehabilitation as part     of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive     impairment and quality of life would improve and that cocaine use would decrease in those     participants receiving occupational-therapy based cognitive rehabilitation.   "
122366|NCT01684280|"     To investigate:        1. Associations between miRNA and insulin signaling-related gene expressions in abdominal          adipose tissues in obese subjects.        2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between          genders.   "
122367|NCT01684267|"     To test the usability and effectiveness of a robotic device, called the Robotic Gait     Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2)     patients with stroke with gait abnormalities secondary to impaired knee function.   "
122368|NCT01684254|"     The present project will focus on evaluating the technical efficacy of the in-shoe gait     monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of     children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.   "
122369|NCT01684241|"     Clinical first-in-human dose escalation study evaluating the safety and tolerability of     intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated     antigens in patients with advanced melanoma   "
122370|NCT01684228|"     End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous     kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over     5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems.     The survival of these patients depends on renal replacement therapies, such as hemodialysis     (HD), which artificially purifies the blood from toxins. The investigators assume that some     of the uremic toxins are also present in the patient's exhaled breath, and could be detected     by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is     based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in     medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by     our collaborator Dr. Hossam Haick (Chemical Engineering, Technion).      In the current study, the investigators utilize this technology to identify VOCs in the     exhaled breath of dialysis patients, and to characterize certain patterns of expression that     could potentially help in future monitoring of HD adequacy. The investigators plan to collect     150 breath samples from patients before and during dialysis, and from healthy subjects. All     participants provide a signed informed consent. Subsequently, analysis of samples will be     done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry and parameters     extracted from each sensor response.   "
122371|NCT01684215|"     This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1     portion is a single-country, non-randomized, open label, clinical trial which will evaluate     the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single     agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination with     letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The Phase     2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center     clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with     letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+) HER2(-)     ABC.   "
122373|NCT01684189|"     Objectives：        1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile          episodes in patients receiving chemotherapy        2. To explore the percentage/distribution of infectious origins of febrile neutropenia        3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia        4. To explore clinical outcomes of different infectious origins/pathogens in febrile          neutropenia episodes        5. To have a clear view of therapeutic actions in the management of hematological patients          with febrile neutropenia and suspected fungal-related febrile episodes   "
122374|NCT01684176|"     Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk     of a new stroke, however, poor adherence to secondary prevention medications occurs     frequently within this patient group. The purpose of this study is to evaluate whether a     complex tailored pharmacist intervention will lead to increased adherence to secondary stroke     prevention medications and less new stroke events when compared to a usual care group.     Interventions focus on motivational interviewing, medication review and telephone follow up.   "
122559|NCT01681758|"     We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in     patients after cardiac surgery who are mechanically ventilated leads to a significant     decrease in the amount of fluid given to such patients in the first 24 hours after surgery   "
122376|NCT01684150|"     The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety     of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary     assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing     rearrangements of the MLL gene.      Currently this study is in the MLL-r restricted/expansion phase and is only enrolling     patients with rearrangements involving the MLL gene, including 11q23 or partial tandem     duplications (PTD).   "
122377|NCT01684137|"     Reduction of the total IgE antibody, improved vital capacity and lung volume measured by     spirometry.      Improving quality of life observed in the visual analogue scale (VAS).   "
122378|NCT01684124|"     The investigators hypothesize that it is feasible and safe to deliver a conservative approach     to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on     average,10 days).   "
122379|NCT01684111|"     To investigate the maximum tolerated dose of BIBF 1120, safety and pharmacokinetics in     escalating doses administered with Vinorelbine i.v. in elderly patients with advanced     Non-Small Lung Cancer (Stage IV).   "
122380|NCT01684098|"     The folate receptor is over-expressed on many types of cancer cells and new folate receptor     targeted therapies are being developed to target cancer cells that over-express the folate     receptor. As with other targeted therapies, it is important to develop diagnostic tests that     will provide accurate information on folate receptor status and aid in selecting patients     that may benefit from folate-targeted therapy.   "
122381|NCT01684085|"     This study is designed to test the effect of an explanation about the first sleep following     trauma exposure, on the development of Post Traumatic Stress Disorder (PTSD) in the months     following the traumatic event.   "
122382|NCT01684072|"     The purpose of this study is to observe the occurrence of adverse reaction and antibody     positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of     live attenuated varicella vaccine without gelatin.   "
122383|NCT01684059|"     The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since     the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via     lipid peroxidation, the induction of oxidative DNA damage and the formation of protein     adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to     L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO     synthases. Several studies suggest that the overproduction of this free radical and the     subsequent excessive exposure to oxidative conditions have a potential pathogenetic     implication, which due to the reduction of sperm motility. The present study was conducted to     study the effect of Zn supplementation on the levels of NO synthase and arginase in semen of     patients with asthenozoospmia.   "
122384|NCT01684046|"     The purpose of this study was to evaluate the performance of Opti-Free® PureMoist®     Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand     name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.   "
122385|NCT01684033|"     The purpose of this study was to evaluate the performance of Opti-Free® PureMoist®     Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS)     in silicone hydrogel contact lens wearers.   "
122386|NCT01684020|"     Rhinoplasty (nasal reconstruction i.e. a nose job) is a surgical procedure performed on the     nose to correct a medical problem or change the appearance of the nose. During the healing     process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may     or may not lessen these effects. This study is looking to see the effects of ARTISS on     adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this     study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to     rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an     external approach.   "
122387|NCT01684007|"     The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both     eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant     eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral     implantation) at Month 3 following the second eye surgery.   "
122403|NCT01683916|"     Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses.     Anesthetic requirements and stress hormone response are compared in SCI patients undergoing     anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or     remifentanil.   "
122481|NCT01682772|"     This is an open-label, single arm, two part adaptive design phase II trial of Olaparib in     patients with advanced castration resistant prostate cancer.      The trial aims to evaluate the the anti-tumour activity of Olaparib in metastatic castration     resistant prostate cancer, identify molecular signatures of tumour cells in responding and     non-responding patients, and to identify predictive biomarkers of Olaparib response.   "
122388|NCT01683994|"     Background:      - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is     approved for medullary thyroid cancer. However, studies have shown that prostate tumors     respond to it. Docetaxel and prednisone are standard treatments for advanced prostate cancer.     Researchers want see if adding cabozantinib to these two drugs can be a safe and effective     treatment for this type of cancer.      Objectives:      - To test the safety and effectiveness of cabozantinib with standard treatments for advanced     prostate cancer.      Eligibility:      - Individuals at least 18 years of age who have advanced prostate cancer that has not     responded to standard treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies will also be performed.        -  Participants will receive the cancer drugs over 21-day cycles of treatment. They will          take docetaxel and cabozantinib on day 1 of each cycle. Each docetaxel infusion will          take about 1 hour. They will also take prednisone by mouth twice each day.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Participants will continue to take the study drugs for as long as their cancer does not          worsen and side effects are not too severe.   "
122495|NCT01682590|"     The purpose of this multicentric, randomized controlled trial is to assess whether the timing     of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90     days in patients with severe acute kidney injury at the failure stage (according to RIFLE     criteria) during the initial phase of septic shock.   "
122389|NCT01683981|"     Due to vasodilatory properties of the NO, one of the therapeutic approaches for IPAH is oral     use of nitric oxide precursors (10). Efficacy of L-arginine is well-documented in the current     literature but there is paucity of data with regard to L-citrulline- malate. Hence, this     study will evaluate therapeutic efficacy of L-citrulline- malate in two categories of     patients with pulmonary hypertension (IPAH, and Eisenmeger syndrome). This randomized     clinical trial utilizes 6-minute walk, pro BNP levels and the echocardiographic indexes an     indicator of functional improvement of the patients.   "
122390|NCT01683968|"     This study is designed to investigate the presence and absence of abnormal heart muscle     contractions during sickle cell crises.      You will be asked to do echocardiography during and after your admission to the hospital. We     will compare tow pictures and study the differences.   "
122391|NCT01683955|"     This study aims to assess postoperative blood loss and transfusion rates in total hip     replacement after one-time administration of topical tranexamic acid.   "
122392|NCT01682954|"     The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for     diabetes prevention among employees with prediabetes.   "
122393|NCT01682941|"     RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer.     Isoflavones are compounds found in soy food that may prevent cancer.      PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating     patients with recurrent prostate cancer or rising prostate-specific antigen   "
122394|NCT01682928|"     OBJECTIVE: To assess the efficacy of subtotal immersion therapy as an option to improve     maternal intravascular volume thereby improving both maternal and fetal hemodynamic status     with reversal of oligohydramnios. This will be measured utilizing the Amniotic Fluid Volume     (AFV) as the primary outcome. Secondary outcomes will be measured using Fetal Doppler     Studies, Maternal vital signs (Blood Pressure, Pulse Pressure, Weight, Pulse) and     input/output.      HYPOTHESIS: Oligohydramnios, secondary to depleted maternal intravascular volume, can be     reversed by improving feto- and uteroplacental perfusion with subtotal immersion therapy.   "
122395|NCT01682915|"     Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, clinically and     genetically heterogeneous neuropsychiatric disorder with lifelong executive dysfunctions. The     ultimate goal of this 3-year case-control imaging genomic study with unaffected siblings and     typically developing (TD) children as controls is to identify useful imaging endophenotype     for ADHD by investigating the structural connectivity, as assessed by diffusion spectrum     imaging (DSI), and functional connectivity, as assessed by resting-state fMRI (rsfMRI) of     brain regions related to cognitive/executive controls with regards to the ADHD status and the     presence of dopamine transporter gene variants (DAT1).      Specific Aims:        1. to validate the executive functions, visuospatial memory, and structural and functional          connectivity in frontostriatal, and frontoparietal circuitries as effective          neurocognitive endophenotypes;        2. to correlate the data from structural and functional connectivity, neuropsychology, and          ADHD core symptoms stratifying by the presence of ADHD, proband-unaffected sibling          dyads, and the presence of DAT1 variant; and        3. To investigate reported candidate genes, in addition to DAT1 variant, related to          dopamine and noradrenergic neurotransmitter systems in the association with          neurocognitive endophenotypes such as DRD1, DRD2, DRD4, DRD5, DBH, MAO-A, ADRA2A,          ADRA2C, NET, and COMT.   "
122396|NCT01682902|"     This trial is conducted in the United States of America (USA). The aim of the trial is to     evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects     with type 1 diabetes.   "
122397|NCT01682889|"     The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on     hemodynamic and on parameters of microcirculation in patients with peripheral arterial     occlusive disease (PAOD).   "
122398|NCT01682876|"     This study was designed to conduct a comparative trial to further evaluate the safety,     immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,     given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2     through 10 years of age.   "
122399|NCT01682863|"     This study is to assess the safety and tolerability of two different doses of QVA149 and     QAB149 in patients with moderate to severe airflow limitation.   "
122400|NCT01682850|"     This study seeks to study the effectiveness of a short mindfulness based pulmonary     rehabilitation program prior to a surgical resection in patients with lung cancer and severe     Chronic Obstructive Lung Disease (COPD).   "
122401|NCT01683942|"     Development of a novel computer software that will assist in measuring the cup/disc ratio in     digital stereo optic disc images.   "
122402|NCT01683929|"     The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar     compared to consuming artificial sweetened drink, and to evalute macronutrient consumption 24     hours post ingestion of the drinks.      We hypothesize that artificially sweetened (AS) consumption will lead to a relatively similar     hormonal/metabolic responses as glucose consumption and therefore to secondary rise of     caloric intake.   "
122404|NCT01683903|"     Treatment of chronic heart failure requires multidisciplinary approaches with a recognized     role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional,     decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of     this disease. After recovery from the acute phase of cardiac infarction, patients admitted to     the rehabilitation center will follow the usual rehabilitation program during the     hospitalization period. This step precludes outpatient follow-up period in our day hospital,     in accordance with their physicians and cardiologists who manage the monitoring. The study     INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the     benefits of a sustainable rehabilitation heart failure on patients treated optimally and     educated during a follow-up period of 24 months. The main objective of the study will be to     compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients     for each evaluation time point, periodically recorded   "
122405|NCT01683890|"     To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring     after simple hysterectomy and to analyze the influence of bladder symptoms and sexual     function change on quality of life of patients.   "
122406|NCT01683877|"     To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian     function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy   "
122407|NCT01683864|"     The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced     phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30%     of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases     in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its     five-year survival rate is less than 2%. Even after R0 resection of a localized gastric     carcinoma the five-year survival rate is only 40%, not least of all because relapses in the     form of peritoneal metastases are a common occurrence.      Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free     tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and     gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which     stands in strong contrast to the 40% risk for patients with negative cytology.      In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion     (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal     chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin     will be administered following gastrectomy in patients with a gastric carcinoma with free     tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B)     solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells     diagnosed in cytology in the preoperative laparoscopy.      A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM     Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional     lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be     included. Exclusion criteria are extended disease or inoperable tumor.      This study is already permitted by the local ethic commission and the German Federal     Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code:     HIPEC_Stomach) and was initiated in August 2012.   "
122408|NCT01683851|"     Hypothesis      The use of Isolite® system does not produce upper airway obstruction in the pediatric     population during dental treatment with conscious sedation.      Purpose:      Report the changes in airway patency and pediatric patient's behavior when Isolite® system is     used for dental treatment with conscious sedation.      Objectives:        1. Determine changes in pulse rate        2. Determine changes in SpO2        3. Recognize breath sound's changes possibly associated with airway blockage        4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental          treatment under conscious sedation        5. Relate the use of Isolite® with the frequency of head reposition to open the airway.   "
122409|NCT01683838|"     Normally, nerve fibers carry electrical impulses through the spinal cord, providing     communication between the brain and the arms and legs. In people with spinal cord injury,     some fibers may be destroyed at the site of injury, while others remain connected but do not     work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal     cord injury may have spasticity which is muscle spasms or muscle stiffness that makes     movement difficult. Fampridine-SR is an experimental drug that increases the ability of the     nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on     moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as     bladder control, bowel function and sexual function. The study will also examine the possible     risks of taking Fampridine-SR.   "
122410|NCT01683825|"     The primary aim of this pilot study is to determine whether amyloid deposits in the heart can     be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission     tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll     15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a     control group.      The primary hypothesis of this study is that a specific amyloid binding radiotracer will bind     to the myocardial amyloid deposits and help quantify cardiac amyloid burden.      A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of     the myocardium.   "
122411|NCT01683812|"     The purpose of this descriptive study is to provide information on the feasibility of using     the cranial cup, a new positioning device, in a small sample of prematurely born infants with     elongated head shapes as a result of laying on their abdomens, during the convalescent phase     of their hospitalizations.   "
122412|NCT01683799|"     The purpose if the study is to determine whether improving sleep, especially slow wave or     deep sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity     and inflammatory responses to pain, and improves OA-related pain.   "
122413|NCT01683786|"     Purpose:      To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment     for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with     undetectable HCV RNA at wk 8.      Study Design:      a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype     1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (<50 IU/ml)     will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b     at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering     this study.   "
122414|NCT01683773|"     This trial will investigate the administration of two new tuberculosis vaccines, called     AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these     vaccines are given one after the other. The trial will assess the safety of both vaccines and     also their ability to stimulate an immune response within the body. It is hoped that when     these two vaccines are given in sequence, the combined immune response is even better than     when each vaccine is used individually.   "
122415|NCT01683760|"     The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used     as prophylaxis of invasive fungal infection in premature infants.   "
122422|NCT01683669|"     Noisy Pressure Support Ventilation (noisy-PSV) would lead to improved lung function, while     preserving respiratory muscle unloading. Basically, noisy PSV differs from other assisted     mechanical ventilation modes that may also increase the variability of the respiratory     pattern (e.g. proportional assist ventilation) by the fact that the variability does not     depend on changes in the patient's inspiratory efforts.      The aim of this study is to evaluate the optimal variability for noisy PSV in patients with     ALI based on its effects on respiratory mechanics, breathing comfort, gas exchange, and     hemodynamics. The investigators hypothesize that noise in pressure support leads to     variations in VT that are able to improve lung function and that physiologic variables     respond differently to the degree of variability in pressure support   "
122468|NCT01683058|"     The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program     and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the     treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive     treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297)     will allow the subjects who complete Trial 291 to enter this open label trial at the     investigator's discretion, where additional safety and tolerability data will be collected.   "
122469|NCT01683045|"     The purpose of this study is to demonstrate that the Estech COBRA Surgical System is an     effective treatment for patients with irregular heart beats who are undergoing heart surgery.   "
122423|NCT01683656|"     HIV-infected patients are at increased risk for cardiovascular disease. Large investigations     support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a     treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only     through its benefit in terms of lipid profile, but also by reducing atherosclerotic     inflammation.      The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on     suppressive cART has the potential for reducing subclinical atherosclerotic inflammation     associated with HIV itself in HIV-individuals on cART.      NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test     the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT)     in 90 subjects.        -  Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5          to the end of the study (the titration aims to reduce adverse reactions)        -  Regimen 2: ER niacin/laropiprant placebo p.m.      The primary end point is the change in mean common carotid intima-media thickness from     baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.      The proposed in vivo experiments should provide insights on the potential benefits of niacin     treatment of cardiovascular disease in HIV patients. In addition, we will be able to further     clarify the role of systemic inflammatory mediators in the development of early     atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment     of non-infectious co-morbidities such as cardiovascular diseases have become essential for     HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere     management of opportunistic infections or virologic suppression.   "
122424|NCT01683643|"     The purpose of the study is to determine whether SBIRT is an effective intervention with     inmates and to estimate the costs of providing SBIRT to this population.   "
122425|NCT01683630|"     This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza     type A to type B following clinical diagnosis of influenza. Multivariate models are used to     assess the effects of influenza type on clinical outcomes while accounting for potential     confounders.   "
122426|NCT01683617|"     Psychological stress occurs when an individual perceives that environmental demands tax or     exceed his or her adaptive capacity. In this view, stressful experiences are conceptualized     as person-environment transactions, whose result is dependent on the impact of the external     stimulus. This is mediated by the person's appraisal of the significance of the stimulus, of     the personal, social and cultural resources available and of the efficacy of the coping     efforts.      Extreme levels of stress can have a negative influence on one's professional life and can     disrupt both the social and personal life of an individual. Stress can also cause different     physiological and psychological disorders such as anxiety, chronic headaches, depression,     withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.      Stress Management Therapy can help to overcome counter effects of stress. Usually various     techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior     Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated     approach covering both stress management and stress treatment is the Cognitive Behavioral     Therapy (CBT) approach.      The trouble with stress is that it is very personal. Thus, stress-related disorders depend a     great deal on how the person experiencing a stressor is put together —psychologically and     physically. So the focus for assessment, prediction and treatment has to be the person's     situated experience.      To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new     paradigm for e-health - Interreality - that integrates contextualized assessment and     treatment within a hybrid environment, bridging physical and virtual world.      From the clinical point of view the INTERSTRESS solution may offer the following innovations     to current traditional protocols for stress management:        -  Objective and quantitative assessment of user's stress level using biosensors and          behavioral analysis;        -  Provision of warnings and motivating feedbacks to improve self awareness, compliance and          long term outcome;        -  Decision Support System (DSS) for treatment planning through data fusion and detection          algorithms.   "
122427|NCT01683604|"     This multi-center, observational study will evaluate the treatment patterns in clinical     practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA)     who have had an inadequate response (or were intolerant to) treatment with non-biological     disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be     collected from each eligible participant initiated on tocilizumab treatment by their treating     physician according to approved label for 6 months from start of treatment.   "
122428|NCT01683591|"     Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to     aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will     evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using     High-resolution impedance manometry (DASH). The hypothesis tested in this study is that     high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate     dysphagia and the diet plan in acute stroke patients.   "
122429|NCT01683578|"     Variable ventilation has been shown to improve lung function and reduce lung damage as well     as inflammation in different models of the acute respiratory distress syndrome. Also,     variable ventilation is able to recruit lungs. The present study will investigate whether     variable as compared to non-variable ventilation improves post-operative lung function and     reduces systemic inflammation in patients submitted to open abdominal surgery.   "
122430|NCT01683565|"     The purpose of this study is to examine whether supplementation with certain polyunsaturated     fatty acids can help development and behavior of children born preterm.   "
122431|NCT01683552|"     Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine     kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the     effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological     therapy-induced pruritus.   "
122511|NCT01682382|"     Subjects with wet AMD, dry AMD, and age-matched controls will undergo routine occular     measurements, will provide a blood and cheek cell sample, and will have macular pigment     optical density (MPOD) measured to determine if there is an association between genetics,     MPOD and the risk of progression to wet AMD.   "
122444|NCT01683383|"     Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability     despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single     most promising intervention for HIE. Reduction of brain temperature by 2° to 5°C has shown to     be neuroprotective in newborn and adult animal models of brain ischemia. Therapeutic     hypothermia instituted within 6 hours of birth has been shown to significantly improve     survival and neurodevelopmental outcome in term newborns with HIE. Hypothermia is most     effective if begun during the latent period, before the secondary energy failure. It is not     known whether cooling initiated after 6 hours of age is effective.      The goal of this proposal is to test the efficacy of the cooling device in achieving the     target temperatures in patients with moderate to severe HIE during transport when compared     with current practices.   "
122432|NCT01683539|"     This study is aimed at evaluating whether the computer-based cognitive exercises in the     Thinking Skills for Work (TSW) program are critical to improving work and cognitive outcomes     in consumers with serious mental illness and cognitive impairment enrolled in supported     employment (SE), or whether a streamlined version of TSW without this component (the     Cognitive Skills for Work (CSW) program) is equally effective for some or all consumers. An     RCT will be conducted at two sites (Mental Health Center of Greater Manchester in New     Hampshire and Thresholds Inc. in Illinois) with 244 consumers randomly assigned to one of two     groups (122 each, with approximately 122 participants having schizophrenia or schizoaffective     disorder and 122 of the participants having other diagnoses): 1) TSW, or 2) CSW. The TSW and     CSW programs will be delivered by the same Cognitive Specialists, who will work as members of     the SE team to integrate cognitive and vocational services. All participants will continue to     receive SE services. Participants will be assessed at baseline, post-treatment at 8 months     (after completion of the active teaching components of TSW or CSW), and at 16 and 24 months     post-baseline to evaluate cognitive functioning, symptoms, and quality of life. All work     outcomes will be tracked weekly.   "
122433|NCT01683526|"     The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent     endotracheal intubation of critically-ill patients has not been well-described in the     literature. This study will answer whether using a VL will impact on the efficacy and safety     of intubation compared with a traditional direct laryngoscopy.   "
122434|NCT01683513|"     In this study the investigators compare the traditional way of triggering with a new way in     patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper     Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/     ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and     pregnancy rate.   "
122435|NCT01683500|"     Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The     shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters     are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.        -  Trial with medical device   "
122436|NCT01683487|"     I. To investigate time measurement from emergency room admission to first antibiotic     administration.      II. To evaluate risk factors for prolonged time to first antibiotic administration.      III. To correlate time measurement with Charlson comorbidity index and multimorbidity     patterns.      IV. To investigate the impact of a delayed time to first antibiotic administration on the     outcome   "
122437|NCT01683474|"     1. objectives             -  Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by               femoral artery             -  Evaluate safety and clinical benefit of percutaneous implantation of the Venue               MedTech aortic valve prosthesis.             -  Continuous observe 12 months of safety and efficacy.        2. Approximately 80 patients presenting with native aortic valve stenosis necessitating          valve replacement which are considered unsuitable for Surgical Valve Replacement, with a          high surgical risk, as attested to by both the surgeon and the cardiologist are          recruited in the study.        3. Safety and performance will be evaluated at discharge and at 30 days post procedure.          Valve safety, performance and placement will be followed up at 6 and 12 months          post-procedure.   "
122438|NCT01683461|"     This is a randomized controlled intervention trial with 1,500 pregnant and postpartum women     to examine the efficacy of an enhanced model of ongoing post-test support for women attending     antenatal and postnatal care in KwaZulu-Natal, South Africa. Through the intervention, the     investigators will tailor voluntary counseling and testing (VCT) for HIV to the ANC setting     and provide a continuum of psychosocial support for pregnant women through: (1) a     standardized health education video before HIV pre-test counseling; (2) HIV pre- and     post-test counseling sessions that prepare women for decisions related to testing, serostatus     disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies for sexual     risk behavior change; (3) two additional post-test counseling sessions postpartum focusing on     legal education and referral, partner testing, sexual risk behavior change and family     planning decisions and; (4) an active referral system to post-test support groups run by a     clinically trained staff psychologist and (5) an active referral system to legal services run     by a lawyer at the clinic.      Through this intervention trial the investigators will be testing the following hypotheses:      H1: Women receiving the intervention will have significantly lower sexual risk of HIV at 14     weeks and 9-months post-partum as compared to women in the control arm. Sexual risk of HIV     will be measured by: STI incidence (Trichomonas vaginalis, Neisseria gonorrhea and     Chlamydia), consistent condom use, unprotected sex in past 30 days, and unprotected sex since     delivery.      H2: Women receiving the intervention will report significantly better outcomes related to     prevention of mother to child transmission (PMTCT) service uptake at 14 weeks and 9 months     post-partum as compared to women in the control arm. PMTCT service uptake will be measured by     acceptance of HIV VCT among HIV-positive and HIV-negative women; acceptance of ARVs,     adherence to national infant feeding guidelines, and family planning use among HIV-positive     women.      H3: Women in the intervention arm will report significantly better psychosocial outcomes at     14 weeks and 9 months post-partum as compared to women in the control arm. Psychosocial     outcomes will be measured by: perceived social support, emotional distress, and partner     violence among HIV-positive and HIV-negative women.   "
122439|NCT01683448|"     This study will be a retrospective study. The patient data from the electronic medical     records and existing database will be collected and analyzed. Primary endpoints will be     postoperative mortality (within 30 days) and overall complications and length of hospital     stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia,     ischemia, stroke, neurological complications, length of ICU stay, re-admission rate,     infections, pulmonary complications, length of intubation time, length of ventilation time,     and acute renal failure.   "
122440|NCT01683435|"     We would like to determine if HBA® testing of sperm in couples with presumed idiopathic     infertility will reveal lower binding percentages than in couples with an identifiable cause     of infertility either male factor or tubal factor   "
122441|NCT01683422|"     The current trial will provide important data on the recurrence rates and patterns of failure     using state of the art target agent, chemotherapy and proton beam technology for patients     with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater     would be considered evidence of a regimen potentially worthy of further study as a new     treatment paradigm in one arm in a future phase III trial.   "
122442|NCT01683409|"     This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the     treatment of participants with mild to moderate diabetic kidney disease.   "
122443|NCT01683396|"     The purpose of this proof-of-concept study is to determine whether gevokizumab is effective     in the treatment of active inflammatory, erosive osteoarthritis of the hand.   "
122536|NCT01682057|"     The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic     Coupler System (ACS) in patients with severe hypertension.   "
125105|NCT01648127|"     The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline     following intravenous administration of a single dose of ceftaroline 600 mg in healthy     subjects who are normal weight, overweight, and obese.   "
122445|NCT01683370|"     STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values,     emergency calls and consultations for fever, and on hospitalizations for FN in children and     adolescents with cancer        -  to describe the frequency of episodes of FN, and of other clinically relevant FN-related          measures        -  to compare these frequencies and measures in reality vs. applying Bernese standard          limits for defining fever (ear temperature ≥39.0°C)        -  to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C          (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow)        -  to determine if it would be useful to perform an interventional study on the question of          different fever limits, powered to study both efficacy (frequency of FN) and safety (AE          in delayed FN diagnosis)        -  to use the platform of this prospective study to explore if the serum level of cortisol          is associated with adverse events in FN      HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions     of fever from ear temperature 39.0°C to lower limits would        -  increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint).        -  increase the rate of other clinically important FN-related measures related to          chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related          measures during treatment of FN episodes diagnosed in reality (secondary endpoints          4,5,6).        -  not relevantly decrease the proportion of FN with AE (secondary endpoint 7).   "
122446|NCT01683357|"     It is not rare that two-stage hepatectomy for multiple bilobar colorectal liver metastases     (CLM) be left incomplete because of disease progression or technical reasons. One-stage     hepatectomy seems a feasible and safe alternative, however, long-term results are lacking.     This study aims to provide evidence that one-stage hepatectomy compelling tumor exposure     provides adequate long-term results with low risk of local recurrences.   "
122447|NCT01683331|"     Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in     decreasing the incidence of NODAT among de novo kidney transplant patients with manifested     post-transplant hyperglycemia during the first week after transplantation.      Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress     related to the surgery and use of higher doses of immunosuppressive medications, and leads to     lower incidence of NODAT at 1 and 2 years.      Specific Aim 2: To determine the improvement in overall glycemic control with the early     initiation of insulin therapy.      Hypothesis 2: Early initiation of insulin therapy results in greater overall control of     glycemia compared to standard care of dietary counseling, life-style modification, oral     hypoglycemic agents and/or insulin as needed at 1 year.      Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to     the early initiation of insulin therapy at one year post-transplantation.      Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of     post-transplant hyperglycemia and preserves better beta-cell function at 1 year.   "
122448|NCT01683318|"     The current study aims to test the efficacy of treatment for a device that utilises a thermal     pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in     patients suffering from meibomian gland dysfunction.      Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators     will monitor them for changes in tear film and lipid composition, as well as changes in the     anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye     symptoms will be documented in form of questionnaires.      The investigators hypothesize that the treatment will be effective in improving clinical     signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian     Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to     patients in Singapore.   "
122449|NCT01683305|"     This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of     cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically     detectable tumors, and those who have detectable tumors, 2) identify all the detectable     markers and 3) establish that biomarkers detected in NAF could also be detected in the     biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable     tumors.   "
122450|NCT01683292|"     In this first study of inhaled apomorphine in Parkinson's disease patients, the primary     objective is to find the minimum efficacious dose of apomorphine that is useful in rescuing     patients during 'off' periods. Safety, tolerability and pharmacokinetics of inhaled     apomorphine will be assessed during the study.   "
122451|NCT01683279|"     Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we     are attempting to use a patient's own T cells, which can be genetically modified to expresses     a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the     leukemic cells though the recognition of CD19, a protein expressed on the surface of the     majority of pediatric ALL. This is a phase I study designed to determine the maximum     tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary     aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic     cells.   "
122465|NCT01683097|"     This study aims at assessing factors that affect patient choices for end of life care. 300     patients would be assigned either to a control arm (questionnaire alone) or intervention arm     (standardized explanation+ questionnaire). Our intervention is a standardized explanation     which explains what code status, advance directive and end of life care mean. Based on     patient responses, factors that affect choices of code status would be analyzed. We will also     evaluate if a standardized explanation improves patient understanding of end of life issues.     This would be determined by generating a composite score of correct responses to a subset of     objective questions in the questionnaire   "
122467|NCT01683071|"     The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome     bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect     achieved following single dose injection femoral nerve block with liposome bupivacaine, and     (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be     tested in Part 2.      Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the     analgesic effect of single injection femoral nerve block of a single dose level of liposome     bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).   "
122496|NCT01682577|"     The objective of this study was to find out whether the bioavailability of PT Dexa Medica's     formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the     innovator's product (Prexum® 4 mg, Servier).   "
122452|NCT01683266|"     Primary Objective:        -  To compare the efficacy of a new formulation of insulin glargine and Lantus (overall,          regardless the injection time) in terms of change of HbA1c from baseline to endpoint          (scheduled Month 6) in participants with type 1 diabetes mellitus      Secondary Objective:        -  To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms          of:        -  Change of HbA1c from baseline to endpoint (scheduled Month 6)        -  Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma          glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma          glucose (8-point profiles), glucose variability, treatment satisfaction and health          related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)        -  Reaching target HbA1c values and controlled plasma glucose (all and reaching target          without hypoglycemia)        -  Frequency of occurrence and diurnal distribution of hypoglycemia by category of          hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)        -  Safety and tolerability of HOE901-U300 including development of anti-insulin antibody          (AIAs) during the 12-month study period   "
122453|NCT01683253|"     The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved     and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist     to levodopa/carbidopa in patients with Parkinson's disease who have been treated with     dopaminergic medications.   "
122454|NCT01683240|"     Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic     device, which is designed to give a better flexibility to the cholangioscopy tip in order to     enable optimal diagnostic and therapeutic precondition. Other than the conventional     mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at     the side of a specially developed duodenoscope (mother part) which is prepositioned distally     to the control unit, near to the patient's mouth. Better manoeuverability of the device tip     will lead to both a better accuracy in taking biopsies as well as a better flexibility in     lithotripsy manoeuvres. This study is designed to test the efficiency of the device in     relation to this assumption.   "
122455|NCT01683227|"     Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive,     integrated public health approach to identify and deliver a spectrum of early detection and     intervention services for substance use in general medical care settings. These settings,     such as emergency department visits, offer a potential teachable moment because patients     may have perceptions of vulnerability about their health, and therefore be particularly     receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT     is effective in reducing alcohol use at varying levels of severity in a myriad of health care     settings including primary care, emergency departments, and trauma centers. Although the     SBIRT approach has shown promise for alcohol, relatively little is known about its     effectiveness for adult illicit drug use specifically.      This will be among the first studies to rigorously test the SBIRT approach for drug use. It     will evaluate the effectiveness of SBIRT for drug use and related factors for 700     multi-ethnic ED patients using a two-group randomized repeated-measures design in which     biologically-validated drug use abstinence and related outcomes of an intervention group are     compared to those of an attention-placebo control group. Over a 14-month period,     bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit     drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and     trauma units. Following consent procedures and standardized baseline assessments, Health     Educators randomly assigned participants to one of the two conditions. The intervention group     received Life Shift, an SBIRT drug use intervention matched to the participant's drug use     risk level. The control group received the same type and quantity of intervention in an     unrelated area—Driving and Traffic Safety (Shift Gears program), also matched to their     driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement     technicians blind to the participant's assigned condition collected standardized self-report     past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported     abstinence. Additional outcome variables are changes in the frequency of drug use, functional     status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health     care utilization.   "
122456|NCT01683214|"     The investigators are conducting this study to test the usefulness of a new type of analysis     of electroencephalographic (EEG) recordings called brain network activation or BNA. BNA     allows to identify patterns of activation in brain networks and to track their changes over     time. The investigators want to examine the possible role of brain network activation (BNA)     in the diagnosis of mood disorders and predicting improvement over time. The procedure     conducted with patients diagnosed with a mood disorder will be compared to people who do not     have a mood disorder.   "
122457|NCT01683201|"     The aim of this research project is to evaluate the efficacy of a specific functional     exercise programme to improve pain, stiffness and physical function in patients post total     hip replacement from week 12 to week 18 post surgery.   "
122458|NCT01683188|"     This is a research study to evaluate treatment of metastatic melanoma patients with a     combination of drugs. The combination being studied is vemurafenib (also known as Zelboraf®)     and High Dose Interleukin-2 (abbreviated as HD IL-2 and known as Proleukin®). The combination     of vemurafenib and HD IL-2 immunotherapy may enhance the response.   "
122459|NCT01683175|"     This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation     IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR)     19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.   "
122460|NCT01683162|"     Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in     preterm infants, a showed efficacy and a good clinical and biological safety profile. The     objective of this study was to assess the effects of a new olive-oil based lipid emulsion     compared with the traditional lipid emulsions.   "
122461|NCT01683149|"     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,     but will not be recruiting locally.      The purpose of this research study is to establish a dose of the combination of drugs,     Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The     chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators are     trying to find the highest dose of Topotecan and Sorafenib that can be given safely to     children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will do     this by testing different doses of these drugs in different groups of children. The     investigators will also study how the body processes these drugs.   "
122462|NCT01683136|"     This is an open study.approximately 20 patients diagnosed with Borderline Personality     Disorder (in case patient is under drug treatment, treatment should be stable within the     prior 4 weeks before study entry).Starting from the third day, subjects would undergo rTMS     (repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks, and will     be clinically evaluated in order to monitor for improvement.      The investigators anticipate a significant reduction in symptoms severity at the end of the     treatment compared to study entry.   "
122470|NCT01683032|"     Creative cognition plays an important role in art, invention and innovation, as well as in     everyday life and thus has a significant effect on society as a whole. Research with healthy,     normal participants and those with attention deficit hyperactivity disorder indicates a     possible inverse relationship between attentional function and creativity. This evidence     raises the possibility that Methylphenidate (MPH; Ritalin) could decrease creativity in     people using it for cognitive enhancement. However, this question has not been addressed by     previous studies. Hence, the present study aims to examine the effect of MPH on creativity in     healthy young adults.   "
122471|NCT01683019|"     This feasibility study investigates effects of EEG-based low frequency, low emission magnetic     cortical stimulation in comparison to a sham treatment in subjects with moderate to severe     depressive disorder.   "
122472|NCT01683006|"     The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy     rate during hypothermia after cardiac arrest.   "
122473|NCT01682993|"     Topography guided laser treatment enables the surgeon to correct higher order aberrations in     corneas with irregular astigmatism. Several case reports and small uncontrolled trials have     been published on the combination of this treatment with corneal cross linking (CCL) in     patients with ectatic corneal diseases.      This randomized study will evaluate the safety and efficacy of a combined treatment of     corneal cross linking with a partial topography guided excimer laser treatment in eyes with     progressive ectatic corneal diseases.   "
122474|NCT01682980|"     The overall contribution of this study is to increase the knowledge of the efficacy of     strength and aerobic exercise on knee related quality of life, knee pain,physical function     and the morphology of the cartilage in patients with knee osteoarthritis (OA). Knee OA is one     of the most important diseases within musculoskeletal conditions affecting a considerable     number of people worldwide. This randomized controlled trial will involve one intervention     group delivered strength exercises compared to another intervention group delivered aerobic     exercise (ergometer cycling). The two intervention groups will be compared to a control group     undergoing usual care. Cost-effectiveness analysis will be performed comparing the three     groups. The study is funded from The Research Council of Norway.   "
122475|NCT01682967|"     Headache following accidental dural punction as during epidural analgesia can be severe and     sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural     puncture. Although spontaneous resolution of headaches is common in most patients within 7     days, in 20% can they be persistent and in some very disabling. The exact reason for the     characteristic headache is unknown, but it is believed to be the result of leakage of     cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more     severe and persistent the headache. This is why larger needles (lower gauge) are known to     have a higher incidence of PDPH. However, the type of needle also seems to play an important     role in the likelihood of PDPH.      Headache following accidental PDPH is very typical as it increases significantly when sitting     or standing and often disappears completely on lying down. It is typically located in the     back of the head, accentuated by light and often decreases with intake of large quantity of     fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.      Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage,     as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing     that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the     hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of     clinical symptoms and signs of accidental PDPH.   "
122476|NCT01682837|"     Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood     pressure among patients with pre- or Stage I hypertension on their customary diet.   "
122477|NCT01682824|"     The goal of this research study is to learn more about eating practices of survivors of     childhood Central Nervous System (CNS) tumors (including brain and spinal cord tumors).      Recent research shows that childhood cancer survivors are experiencing many health issues     months or even years after active cancer treatment (for example, irregular blood sugar     levels, overweight/obesity, and heart disease). To address this growing concern, researchers     at MD Anderson Children's Cancer Hospital and Texas Children's Cancer Center have joined     forces to learn more about how to design a program that would promote healthy lifestyles     among survivors of childhood cancer.   "
122478|NCT01682811|"     GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic     therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin.      SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and     efficacy of PDT using 5-aminolevulinic acid (ALA) and 630 nm light in the treatment of benign     dermal neurofibromas.      Specifically, the primary goal of the current study is to determine the maximum tolerable     light doses that can be administered to subjects undergoing topical photoillumination     photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical     Solution.   "
122479|NCT01682798|"     The purpose of this study is to determine whether Yili Chang Qing Pro-ABB yoghurt is     effective in improving mild constipation and the intestinal micro-ecology environment &     alimentation.   "
122482|NCT01682759|"     This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the     sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic     control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks,     the mean change from baseline in hemoglobin A1C (A1C) in participants treated with     omarigliptin is non-inferior compared with that in participants treated with glimepiride.   "
122493|NCT01682616|"     This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of     ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic     Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess     the safety profile, to determine the maximum tolerated dose and establish the Recommended     Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose     escalation portion of the study will include approximately 30 subjects. Once the recommended     phase two dose and schedule have been determined, up to 20 additional subjects will be     enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi,     or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs,     as defined by iwCLL NCI/WG criteria for tumor response, subjects may re-initiate ABT-199.   "
122483|NCT01682746|"     The goal of this proposal is to evaluate a new Photodynamic Therapy (PDT) modification which     could revolutionize the treatment of brain tumors in children and adults. There are currently     few cases published involving the use of PDT in infratentorial (in the posterior fossa) brain     tumors in general and specifically those occurring in children. The investigators propose to     test a technique, for the first time in the U.S., that demonstrated in Australian adult     glioblastoma patients dramatic long-term, survival rates of 57% (anaplastic astrocytoma) and     37% (glioblastoma multiforme). These results are unprecedented in any other treatment     protocol.      Photodynamic therapy (PDT) is a paradigm shift in the treatment of tumors from the     traditional resection and systemic chemotherapy methods. The principle behind photodynamic     therapy is light-mediated activation of a photosensitizer that is selectively accumulated in     the target tissue, causing tumor cell destruction through singlet oxygen production.     Therefore, the photosensitizer is considered to be the first critical element in PDT     procedures, and the activation procedure is the second step. The methodology used in this     proposal utilizes more intensive laser light and larger Photofrin photosensitizer doses than     prior PDT protocols in the U.S. for brain tumor patients. The PDT will consist of     photoillumination at 630 nm beginning at the center of the tumor resection cavity, and     delivering a total energy of 240 J cm−2. The investigators feel that the light should     penetrate far enough into the tissue to reach migrating tumor cells, and destroy these cells     without harming the healthy cells in which they are dispersed.      The investigators will be testing the hypothesis that pediatric subjects with     progressive/recurrent malignant brain tumors undergoing PDT with increased doses of     Photofrin® and light energy than were used in our previous clinical study will show better     progression free survival (PFS) and overall survival (OS) outcomes. PDT will also be     effective against infratentorial tumors. The specific aims include determining the maximum     tolerable dose (MTD) of Photofrin in children and looking for preliminary effectiveness     trends.   "
122484|NCT01682733|"     The proposed study is a prospective, pilot study to assess the feasibility of a novel     endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for     the primary treatment of obesity. The investigators aim to recruit ten subjects with a body     mass index between 30-40 for this study. Vertical sutures will be performed using the     endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum     toxin(approximately 30 units) will be injected around the sutures insertion sites in half of     the subjects randomly to slow down muscular grinding of the stomach to see if it improves     durability of the procedure.   "
122485|NCT01682720|"     This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with     ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.   "
122486|NCT01682707|"     Opioids provide greater patient comfort during intubation, but are not able to abolish     completely the release adrenergic hormones during the laryngoscopy, which may cause     undesirable hemodynamic changes.      In this study the investigators selected two techniques commonly used for intubation,     laryngoscopy and track light, so the investigators can verify which intubation techniques     provides less hemodynamic changes in coronary patients under standard anesthesia induction.   "
122487|NCT01682694|"     A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected     by a reduction in serum C-reactive protein.   "
122488|NCT01682681|"     The purpose of this study is to evaluate the long-term retention rate of topiramate in     participants with epilepsy (seizure disorder).   "
122489|NCT01682668|"     This program aims to understand the role of the subthalamic nucleus in the control of the     movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction     contributes to akinesia and how the STN stimulation improves motor signs in PD patients .   "
122490|NCT01682655|"     In the past decades, obesity in children is much more prevalent in the world. Given the     increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.      Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat     content in adults.      The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP)     influence fatty liver in obese children and adolescent.   "
122491|NCT01682642|"     In this study of endometriosis patients we compare a common treatment of surgical therapy and     medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In     both cases they immediately start In Vitro Fertilization (IVF) treatment.   "
122492|NCT01682629|"     The investigative team's purpose for conducting this research is to improve effective and     efficient translation and implementation of evidence based advanced life support practice to     providers of care for children. This specific project aims to accomplish 2 major goals. The     investigators aim to evaluate the utility of a debriefing script specifically designed to     facilitate debriefing when used by novice Pediatric Advanced Life Support instructors during     low and high realism simulation-based learning. Secondly, the investigators hope to evaluate     the effectiveness of high realism simulation vs. low realism simulation in achieving     PALS-based educational outcomes, such as knowledge and skill acquisition.      The investigators hypothesize that SCRIPTED debriefing by novice instructors following low     and high fidelity simulation-based learning will :        1. Improve the cognitive performance and knowledge of multidisciplinary team members as          assessed by a cognitive performance tool and multiple choice testing compared with more          traditional, NON-SCRIPTED debriefing;        2. Improve the behavioural, teamwork and communication skills of multidisciplinary team          members as assessed by a validated assessment tool compared with more traditional,          NON-SCRIPTED debriefing;      The investigators hypothesize that HIGH REALISM simulation-based learning will:        1. Improve the cognitive performance and knowledge of multidisciplinary team members as          assessed by a cognitive performance tool and multiple choice testing compared with more          traditional, LOW REALISM simulation;        2. Improve the behavioural, teamwork and communication skills of multidisciplinary team          members as assessed by a validated assessment tool compared with more traditional, LOW          REALISM simulation;   "
122538|NCT01682031|"     This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing     mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin     and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients     receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more     effective than a placebo in reducing mucositis   "
125106|NCT01648114|"     The investigators will conduct an educational intervention for pregnant women who are     planning to breastfeed to promote exclusive breastfeeding and to increase the duration of     breastfeeding.   "
122494|NCT01682603|"     To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on     neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of     expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of     patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI)     patients.   "
122499|NCT01682538|"     The study is primarily being performed in order to demonstrate bioequivalence between the     Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also     contain a comparison of the bioavailability of the suspension given with food and on an empty     stomach.   "
122500|NCT01682525|"     To provide a novel fertility preservation option for patients facing a fertility threatening     cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation     program. To determine if ovarian tissue cryopreservation provides women with a useful,     successful option for fertility preservation      The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an     alternative option for fertility preservation.   "
122501|NCT01682512|"     The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI     695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and     rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on     the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to     Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.   "
122502|NCT01682499|"     This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg)     infusion for prevention of taxane induced neuropathy in patients with early stage breast     cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles     or every week for 12 weeks.   "
122503|NCT01682486|"     The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s     tolerability, safety and performance and compare it to a standard un-coated Endotracheal     tube.   "
122504|NCT01682473|"     To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of     ZSTK474 in patients with advanced solid malignancies.   "
122505|NCT01682460|"     Research indicates that many people who are being treated for glaucoma have dry eyes. The     purpose of this study is to test the use of artificial tears to alleviate dryness signs and     symptoms in people who are using medication to treat glaucoma. The study hypothesis is that     the use of artificial tears will result in an improvement in clinical signs and symptoms     associated with dry eyes.   "
122506|NCT01682447|"     The purpose of this project is to investigate whether a 12-week, fulltime pulmonary     rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life     in patients with Chronic Obstructive Pulmonary Disease (COPD).   "
122507|NCT01682434|"     Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate     myopia.      Advances over the last decade have allowed LASIK to also correct higher order wavefront     aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided     treatment. However, it remains to be established whether there is a beneficial effect in     higher degrees of myopia.      The study aims to determine whether myopic subjects (-6 to -10 diopters) with     higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided     treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional     treatment in the other.   "
122508|NCT01682421|"     After corneal transplantation, topical corticosteroids are used to reduce the risk of     rejection.      However, the optimal postoperative treatment regimen is unknown. In most cases, a topical     steroid is administered for at least 6 months after surgery, but it remains to be determined     whether potent steroids offer better protection than weak steroids. Also, the length of the     treatment is debated.      Since the use of steroids is not without potential serious ocular side effects, it is of     considerable importance to investigate these problems.      The study aims to examine the frequency of rejection episodes after posterior lamellar     keratoplasty; specifically comparing a short course of potent steroids versus a long course     of weak steroids.   "
122509|NCT01682408|"     Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is     Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted     State, and to Assess the Relative Bioavailability of Process Variants of Tablets   "
122510|NCT01682395|"     The purpose of this study is to obtain a better understanding of the best management of     left-sided colonic emergencies.   "
122512|NCT01682369|"     Infants and young children do not respond as well as adults to the flu vaccines currently     available in the UK. Fluad, is a different type of influenza vaccine that has been available     in the European continent for the last decade, and contains an adjuvant known as MF59.      This vaccine has been used extensively in adults over 65 years of age. It has been     administered to over 4000 children in previous studies, which have shown that it produces an     enhanced immune response in children compared with traditional vaccines, and that it is safe     in this age group. It is, however, not yet licensed for use in children. The reason for this     new study is to gain a better understanding of the how this vaccine is stimulating the immune     system, by looking to see which parts of the genetic code are 'switched on' in response to     immunisation, and to see how this differs from the response to currently used flu vaccines.      To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive     either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines     currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find     out whether it is possible to identify patterns of genetic response which can predict     responses to immunisation. Being able to do so could potentially enable more rapid     development of vaccines against influenza and other diseases in the future. We will also     measure how well the immune system responds to the two vaccines and look at any side effects.      The study is funded by Aditec is a collaborative research programme that aims to accelerate     the development of novel and powerful immunisation technologies for the next generation of     human vaccines.   "
122529|NCT01682148|"     The aim of this study is to compare Dysport treatment results after current clinical practice     injection technique and high-concentration dilution to the neuromuscular junction targeted     injection technique and low-concentration dilution in the elbow joint assessed by Modified     Ashworth Scale 4 weeks post treatment. The hypothesis is that one high volume injection     centrally located in the area/band of the NMJ zones will be as effective as the technique     used today in current medical practice.   "
122560|NCT01681745|"     This study is designed to characterize the biological response of the epidermis, dermis and     subcutaneous tissue to treatment with the myoscience Cryo-Touch III system.   "
122561|NCT01681732|"     A pilot study to test the feasibility of a personalized asthma care intervention.   "
122513|NCT01682356|"     The purpose of this study is to determine if nitrates in a food, in this case - beetroot     juice (BRJ) - is efficacious in improving exercise tolerance and/or peak power in patients     with heart failure. The investigators will also determine if BRJ improves blood pressure,     exercise efficiency, vascular and muscle function, and whether blood levels of nitrates     increase hourly for a total of 4 hours after BRJ ingestion. A secondary aim is to determine     if BRJ-derived nitrates are still effective at 1, 2 and 4 weeks after starting treatment. A     tertiary aim is to determine the variation in the 6 minute walk test. Subjects will answer a     basic medical information sheet and undergo a 6-minute walk test. After at least a 48 hours     rest, subjects will be asked to repeat the 6 minutes' walk. The investigators will (1)     determine if BRJ (as compared to placebo) improves peak power output in heart failure     patients and controls (at ~ 1½ to 2 hours after ingestion); (2) compare the changes in     cardiac muscle (on average ~ 8-12 hours after) BRJ or placebo ingestion in patients who will     be undergoing an left ventricle (LV) assist device placement for clinical purposes. (a     cross-sectional study); (3) determine if BRJ decreases elevated pulmonary artery (PA)     pressures or improves vascular and/or microvascular function (at ~ 1½ - 2 hours after     ingestion) in patients who are already coming in for a PA catheter placement for clinical     purposes; (4) compare the physiological changes after BRJ ingestion in non-heart failure     control subjects with those of patients with heart failure. Endpoints measured at the same     time points after ingestion. The investigators hypothesize (1) that patients with heart     failure and controls will have improved exercise capacity and power at lower oxygen cost (and     thereby greater efficiency) ~ 1½- 2 hours after ingesting beet juice (BRJ) than after     ingesting placebo (beet juice without nitrates); (2) that patients with heart failure will     have a greater physiologic response to BRJ than non-heart failure controls since the former     have worse physiological function to start with; (3) that patients with high pulmonary artery     pressures will have an improvement in the pressures after ingestion with BRJ; (4) that     myocardial perfusion will be higher after BRJ ingestion than after placebo; (5) that cyclic     guanosine monophosphate (cGMP) levels will be increased in left ventricle assist device     (LVAD) samples after BRJ ingestion compared with placebo.   "
122514|NCT01682343|"     The purpose of this study is to investigate the appetite, insulin and incretin hormone     responses to a high-calcium meal.   "
122515|NCT01682330|"     The purpose of the present study is to evaluate the long-term effects of 1 year of     high-intensity fitness training and low-intensity whole-body vibration training on muscle     strength and functionality. Therefore, muscle strength and functionality are measured after a     6-yr interval in older adults (65+).   "
122516|NCT01682317|"     The purpose of this study is to address the gap in knowledge regarding the relationship     between eating frequency and weight loss.   "
122517|NCT01682304|"     Preliminary data from the investigator's lab identified novel patterns of differential DNA     methylation in genes regulating cardiovascular and metabolic function in blood from women     during the first trimester of pregnancy who were destined to develop preeclampsia (PE) in the     third trimester. Further, common patterns of differential DNA methylation were found in the     common genes from placental tissue at time of birth in the same women after diagnosis with     PE, suggesting that the epigenomic patterns that predict pregnancy-induced hypertension may     also underlie the development of chronic hypertension years after.      It is unknown whether aberrant DNA methylation in pregnancy-induced hypertension is the     mechanism by which chronic hypertension develops in these women remote from pregnancy nor is     it known if hypertension remote from PE is as responsive to therapeutic treatment of     hypertension compared to women who develop hypertension without history of PE. The     investigators plan to objectively test the central hypothesis and attain the objective of     this project   "
122518|NCT01682291|"     The primary objective of this study is to compare the efficacy and tolerability of a     life-style modifications protocol versus a protocol including life-style modifications along     with a novel combination of dietary supplement in the management of subjects diagnosed as     having pre-hypertension.      The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna     (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250     mg/day)   "
122519|NCT01682278|"     The aim of this study is to evaluate if amalgam removal is associated with improved     self-reported health, compared to no amalgam removal. The main target group consists of a     group of patients with medically unexplained physical symptoms (MUPS), which they attribute     to dental amalgam restorations. The patients should furthermore express the wish to have     these amalgam fillings removed. The project is designed as a prospective cohort study,     consisting of three groups recruited separately. The main target group will be compared with     two comparison groups: one group of patients with MUPS recruited from general practice and     one group of healthy study patients, recruited at dental practice. The primary research     question is if amalgam removal is associated with improved self-reported health, compared to     no amalgam removal, one year after completed amalgam removal.   "
122520|NCT01682265|"     The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency     6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP)     patients.   "
122537|NCT01682044|"     This phase II trial studies the side effects and how well giving pegfilgrastim together with     rituximab works in treating patients with untreated, relapsed, or refractory follicular     lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL).     Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells     found in bone marrow or peripheral blood and may help the immune system recover from the side     effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in     different ways. Some block the ability of cancer to grow and spread. Others find cancer cells     and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together     with rituximab may kill more cancer cells   "
122521|NCT01682252|"     This study is being done as the doctor investigators would like to lessen the amount of blood     transfusions given to patients. Patients who receive blood transfusions have a greater chance     of developing complications after surgery. There is a device called the Cell Saver that     allows the doctors to process blood that is lost during surgery and return it to the patient.     This lessens the amount of transfused blood the patients receive. This device is not used for     patients undergoing surgery for muscular skeletal tumors.The investigators are not sure     whether tumor cells are present in the blood which is lost during the course of an operation     like yours. The goal of this study is to see if we lessen the amount of blood transfusions     given to patients who may have tumor or cancerous cells present in their blood. One way to do     this is to test the blood that is circulating in your veins and also to test the blood which     is lost during the course of your operation   "
122522|NCT01682239|"     Chronic right ventricular apical pacing has been associated with negative hemodynamic     effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors.     An important factor seems to be optimal lead positioning. Data regarding left ventricular     function impaired by lead positioning is insufficient. The aim of the present study therefore     is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing     (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and     clinical outcome.   "
122530|NCT01682135|"     This trial is testing ramucirumab (LY3009806) administered to Chinese participants with     advanced solid tumors that are resistant to standard therapy or for whom no standard therapy     is available. The purpose of this study is to evaluate how safe ramucirumab is and whether it     causes any side effects. The study will also measure how much ramucirumab gets into the blood     stream and how long it takes the body to get rid of it.   "
122531|NCT01682122|"     Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This     study will evaluate the frequency and persistence of wide pulse pressure in the neonatal     population. Using a prospective study design in the Regular newborn and Observation nurseries     of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have their blood     pressures measured using the oscillometric method. This data will offer insight into whether     the presence of wide pulse pressure in otherwise healthy newborn infants warrants further     cardiovascular evaluation   "
122532|NCT01682109|"     Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years     of age and at least one of their parents. Children will be included, who received     (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children     with primary immune deficiency or cancer.   "
122533|NCT01682096|"     The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is     problematic when both, electrocardiogram and serum troponins are normal. Multidetector row     computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of     coronary artery disease.      The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic     strategy based on MDCT as compared to a strategy using stress echocardiography in the workup     of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary     artery disease. Additionally, the cost associated with both strategies will be compared.      Methods. A total of 150 patients with acute chest pain coming to the emergency room with     intermediate probability of significant coronary artery disease, normal ECG and troponins     will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients     showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive     results will be admitted for further study. The primary endpoint of the study is the     detection of an acute coronary syndrome, defined as typical or atypical angina with     documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a     positive stress test or the occurrence of cardiac death, myocardial infarction or need for     revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be     evaluated by an experienced radiologist and cardiologist.   "
122535|NCT01682070|"     The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum     pratense based on reduction of upper airways reactivity after 5 months of treatment with     different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety     and tolerability will be assessed by the number of related Adverse Events of different     dosages of SUBLIVAC FIX Phleum pratense compared to placebo.   "
122540|NCT01682005|"     This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq®     and Rotarix®) among children aged less than 5 years using insurance claims data from     commercial plans and Medicaid low-income population. The impact of incomplete and complete RV     vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months,     8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).   "
122541|NCT01681992|"     The purpose of this study is to evaluate end of shelf-life potency in terms of the     immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck     & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).   "
122542|NCT01681979|"     Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the     most commonly used classes of medicines during pregnancy. Maternal asthma and in particular     poorly controlled asthma has been found to be associated with a number of adverse perinatal     outcomes including preterm delivery, low birth weight and pre-eclampsia. At present little is     known about the safety in humans of many anti-asthma medicines when used during pregnancy. As     a result all inhaled corticosteroids, with the exception of budesonide which is category B,     have an FDA pregnancy category C, indicative of the fact there are no adequate and well     controlled studies in humans.      Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often     in combination with the long-acting β-agonist salmeterol. Owing to small numbers of pregnancy     exposures in the past, little is known about the safety of fluticasone propionate when used     during pregnancy. A recent feasibility study, however, has shown that there are sufficient     numbers of first trimester exposed pregnancies on the General Practice Research Database     (GPRD) to allow the overall risk of major congenital malformations (MCMs) to be evaluated.     This study also demonstrated that using data from the GPRD it is possible to determine an     individual's exposure to anti-asthma medicines during pregnancy and to classify her treatment     in terms of the British Thoracic Society treatment steps based on linked prescription and     primary care data.      The aims of this study are to 1) evaluate the safety profile of fluticasone propionate (FP)     compared with exposure to all other inhaled corticosteroids with all major congenital     malformations combined as the primary endpoint, whilst taking into account potential     confounders and exposure to other anti-asthma medicine; and 2) test the null hypothesis that     exposure to fluticasone propionate during the first trimester of pregnancy is not associated     with increased overall risk of all major congenital malformations when compared to the risk     in those exposed to other inhaled corticosteroids during the first trimester of pregnancy.      The study will be a retrospective cohort study and will use data from the United Kingdom's     General Practice Research Database (GPRD). The GPRD contains longitudinal medical records     collected within UK primary care. All medical symptoms and diagnoses are recorded in the     database, including those relating to pregnancy, in the form of Read Codes. In addition to     coded data GPs have the option of recording un-coded comments ('free text'), such as more     detailed descriptions of diagnoses or treatments along with information provided to them via     hospital letters, referrals and discharge summaries.      As the recording of stillbirths, neonatal deaths and pre-term births on the GPRD has not been     verified, a verification exercise will be carried out. This will involve requesting and     reviewing free text comments for 100 stillbirths, 100 neonatal deaths and 100 pre-term     births. Free text comments will be requested if they are associated with a medical code     related to pregnancy, delivery, post natal visits, death, post mortem, hospital letters and     other forms of communication. If the free text is not found to be informative we will send     questionnaires to the woman's GP.      All outcomes will be identified and verified blinded to asthma treatment and severity levels.   "
122543|NCT01681966|"     LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended     for local infiltration into surgical wounds. The purpose of this study is to determine the     ease of usage and administration of LNP in the surgical setting, to follow the     Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia     witnessed in the surgical setting.   "
122544|NCT01681953|"     The overall objective of this trial is to evaluate the efficacy and safety of repeated     Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with     alpha-Mannosidosis   "
122545|NCT01681940|"     The overall objective is to evaluate the long-term efficacy, safety and tolerability of     repeated Lamazym i.v. treatment in patients 5-21 years of age with alpha-Mannosidosis   "
122546|NCT01681927|"     Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually     exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid     retention syndrome and orthostatic edema.      The present studies were designed to 1. Improve our ability to identify patients with     idiopathic edema by extending the clinical criteria from an increase in weight of > 1.4 kg     between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the     history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without edema     in idiopathic edema and autonomic failure that will identify a greater number of patients     suffering from variable degrees of weight gain and compare to controls or other conditions     associated with edema. The study will focus mainly on subjects with polycystic ovaries and     autonomic failure. 3. Provide a reasonable course of therapy that is presently not well     defined. 4. Provide evidence that orthostatic edema or weight gain has two common etiologies,     a. an increase in vascular membrane as in idiopathic edema and b. pooling of blood in the     lower extremities in autonomic failure due to a lack of vascular tone.   "
122556|NCT01681797|"     The purpose of this study is to determine whether fluorescence angiography is an     effectiveness technique for the localization of vascular perforators and their area of     perfusion and for the postoperative monitoring of flap perfusion.   "
122557|NCT01681784|"     To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations     in diagnosing different urodynamic diagnoses.   "
122558|NCT01681771|"     The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term     effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on     depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in     patients with chronic heart failure and depression.   "
122547|NCT01681914|"     Utilizing funding through the President´s Emergency Plan for AIDS Relief (PEPFAR) this     project seeks to assess the effectiveness of a subset of the new Mozambican clinical     guidelines for the diagnosis, initial management, and follow-up ( >1 follow-up visit to     determine response to initial and/or second-line therapy) of common signs and symptoms in     HIV-infected adult patients as used under field conditions by Mozambique-based clinicians in     MOH health facilities in Zambézia province, Mozambique. The operational feasibility of the     new guidelines will be described; they will be compared to the previous standard of care for     the problem(s) of interest, and the clinical importance of differences between guidelines     designed for Mozambican non-physician clinicians and new guidelines (also issued in late     2009) for Mozambican physicians will be described. The subset of guidelines to be addressed     in the current phase of this 2-year project includes algorithms for diagnosis and management     of acute fever, persistent fever, and anemia.   "
122548|NCT01681901|"     This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older     patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may     help find breast cancer and find out how far the disease has spread   "
122549|NCT01681888|"     Movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent     voluntary movement. Studies have suggested that using biofeedback to increase awareness of     muscle activation can improve motor function in patients with motor deficits. The     investigators hypothesize that the daily use of a surface electromyographic (SEMG)     biofeedback device for one month will improve motor function in children and young adults     with dystonia, hypertonia, and/or spasticity. The SEMG biofeedback device is worn over the     muscle(s) the subject has difficulty in controlling and provides vibratory feedback about     muscle activation. Groups of children and young adults (ages 3-21), with dystonia,     hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory     feedback device on their affected muscle(s) for 5 hours a day for one month. The device will     vibrate and emit a blue light when the muscle is activated. At the start of the experiment,     subjects will be tested on the Goal Attainment Scale (GAS), the Pediatric/Adolescent Outcomes     Data Collections Instruments (PODCI), and the Barry Albright Dystonia Scale (BAD). For one     month, subjects will practice goals without device. After a month, subject will be assessed     again and be given device to practice goals for a month. After one month, the subjects will     be tested on the outcome measures again and return device.   "
122550|NCT01681875|"     Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine     content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction,     other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure,     intention to quit, compensatory smoking, other tobacco use, cigarette characteristics,     cognitive function, cardiovascular function, and perceived risk. We will also consider     differences between conditions in compliance with product use.   "
122566|NCT01681667|"     Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is     also known that ibuprofen levels in the blood rise higher and faster if the medication is     taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a     liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also     determine whether patients with sore throat prefer to take pill or liquid form of the     medication.   "
122613|NCT01681056|"     The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality     of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is     quality of life.      The hypothesis of this study is that autosuggestion will increase geriatric patient's quality     of life based on its impact to psycho-neuro-endocrine-immune pathways.   "
122551|NCT01681862|"     High blood pressure is the number one cause of death for Blacks in the United States. A major     reason for the high rates of cardiovascular deaths is poor blood pressure control. Improving     blood pressure control leads to large reductions in cardiovascular deaths in Blacks and can     be achieved through interventions targeting self-management behaviors. Yet, despite the     proven benefits of these interventions, there is little evidence of their role in     community-based settings. In NYC, the Department of Health and Mental Hygiene (DOHMH) has     developed Keep on Track, a volunteer-run, community program that aims to lower blood pressure     of older adults through blood pressure monitoring sessions, brief counseling and health     education. With support from DOHMH, lay health workers at faith-based organizations and     senior centers take blood pressure readings for community members, record their readings on     index cards and provide counseling to support lifestyle change and health care access.     However, lay health workers administrating the program report difficulties managing the     volume of tracking cards, and express interest in better tools to manage the information. To     address this limitation, the primary aim of this study is to test the feasibility of     implementing a Personal Health Record (PHR) system in two predominately Black churches in NYC     to help lay health workers track changes in blood pressure and health behaviors of the     participating congregants. The secondary aims are to evaluate the effect of the PHR system on     changes in blood pressure, physical activity, weight loss, fruit and vegetable intake, and     number of visits to a primary care physician from baseline to 9 months. The investigators     hypothesize that congregants who enroll in the PHR system will have a greater reduction in     BP; an increased intake of fruits and vegetables and levels of physical activity; weight     loss; and report a great number of visits to their doctor at 9 months.   "
122552|NCT01681849|"     The purpose of this study was to assess the effects of the medication paroxetine on symptoms     of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related     to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD     symptoms accompanied by changes in brain functional response to reminders of childhood     trauma.   "
122553|NCT01681836|"     This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will     result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited     toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in     vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and     nitrite capsules for cardiovascular disease.   "
122554|NCT01681823|"     To determine if the oral administration of PectaSol-C Modified Citrus Pectin (MCP) is     effective at improving Prostate Specific Antigen (PSA) kinetics in men with biochemical     relapsed prostate cancer and serial increases in PSA levels. Also, documentation of any side     effects or benefits within parameter of the study is included.   "
122555|NCT01681810|"     This research study is being conducted to examine the effects of daily inorganic nitrite     treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese     adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy     may have a major impact on the prevention and treatment of both diabetes and cardiovascular     disease.   "
122563|NCT01681706|"     The purpose of this non-interventional study is to implement a survey initiative to assess     HIV prevalence for one or more diseases and/or conditions within a specific segment of the     population not yet diagnosed with HIV, who presents for care with the specific     disease/condition.      The list of diseases below is not indicative of the most important indicator diseases for HIV     but rather a list of diseases suggested for surveillance.      This study will enrol patients presenting with the following diseases/conditions:        1. Presenting for care of malignant lymphoma, irrespective of type        2. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN II and above)        3. Presenting for care of Hepatitis B or C virus infection (acute or chronic - and          irrespective of time of diagnosis relative to time of survey),        4. Presenting with ongoing mononucleosis-like illness        5. Presenting with unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks        6. Presenting with seborrheic dermatitis / exanthema        7. Presenting with pneumonia, admitted to hospital for at least 24h        8. Presenting with unexplained lymphadenopathy        9. Presenting with peripheral neuropathy of unknown cause (diagnosed by neurologist)       10. Presenting with primary lung cancer       11. Presenting with severe or recalcitrant psoriasis (newly diagnosed)   "
122564|NCT01681693|"     The current study is part of a large multi-investigator grant to look at the pharmacogenetics     of a number of membrane transporters. The investigators will study individuals with     particular genotypes of the human organic cation transporter, (hOCT3), and the multidrug and     toxin extrusion transporter, MATE1 to test the hypothesis that genetic variation in hOCT3 and     hMATE1 are associated with variation in the pharmacokinetics and/or pharmacodynamics of the     antidiabetic agent, metformin.   "
122565|NCT01681680|"     The current study is part of a large multi-investigator grant to look at the pharmacogenetics     of a number of membrane transporters. The investigators will study individuals with     particular genotypes of the human organic cation transporter, (hOCT2), and the multidrug and     toxin extrusion transporters, MATE1, MATE2-K to test the hypothesis that genetic variation in     hOCT2, hMATEE1 and hMATE2-K are associated with variation in the pharmacokinetics and/or     pharmacodynamics of the antidiabetic agent, metformin.   "
122608|NCT01681121|"     This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in     the treatment of excessive daytime sleepiness in adults with narcolepsy.   "
122567|NCT01681654|"     Research on physical activity and nutrition interventions aimed at positively impacting     symptom management, treatment-related recovery and quality of life has largely excluded head     and neck cancer populations. This translates into a lack of clinical programming available     for these patient populations. Head and neck cancer patients deal with severe weight loss,     with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times,     decreased quality of life (QoL), and impaired physical functioning. To date, interventions to     address body composition issues have focused solely on diet, despite findings that     nutritional therapy alone is insufficient to mitigate changes. A combined physical activity     and nutrition intervention, that also incorporates important educational components known to     positively impact behaviour change, is warranted for this population. Pilot work suggests     that there is large patient demand and clinic support from the health care professionals for     a comprehensive program. Therefore, the purpose of the present study is to examine the impact     of timing of a 12-week PA and nutrition intervention (either during or following treatment)     for HN cancer patients on body composition, recovery, serum inflammatory markers and quality     of life. In addition, the investigators will examine the impact of a 12-week maintenance     program, delivered immediately following the intervention, on adherence, patient-reported     outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and     side-effects), as well as return to work. The investigators hypothesize that (1) patients who     are randomized to the intervention at treatment start will experience improved symptom     management and decreased lean body composition changes, directly improving recovery and QoL;     (2) patients who receive a maintenance support program will have better long-term adherence     and therefore superior treatment-related symptom management, physical and psychosocial     functioning; and (3) return to work indices will improve and healthcare utilization costs     will be lower in the participants who receive the immediate intervention (vs. delayed) as     well as in those who receive the maintenance program (vs. no maintenance). This research will     facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path     for a physical activity and wellness education model that can be implemented in other cancer     centers.   "
122568|NCT01681641|"     Parkinson's disease is a chronic progressive neurological disorder. Symptoms are tremor,     slowness in movement, rigidity and postural instability. As the disease progresses and     treatment with L-dopa is no longer sufficient, some patients may be treated with deep brain     stimulation.      When treated with deep brain stimulation, electrodes are inserted in the affected area of the     brain and through stimulation, motor symptoms of Parkinson's disease are significantly     reduced.      During the first year of DBS treatment patients and spouses may experience changes in     everyday life and illness trajectory posing new opportunities as well as new challenges.      The purpose of the study is to develop an individualised and targeted nursing program to     support patients and relatives manage changes and challenges in life the first three months     after Deep Brain Stimulation. The intervention is expected to generate important knowledge     that will serve as a foundation for the further development of a future nursing program.   "
122569|NCT01681628|"     Thought Field Therapy (TFT) is a simple technique that involves tapping on points of the body     corresponding to the meridians used in acupuncture. By using specific sequences, TFT can be     used to treat a variety of psychological problems. Patients can be taught to treat     themselves, and lay people can be trained to treat others in their community, as has been     shown for narrative exposure therapy.      Thought Field Therapy has been used to treat whole communities who have suffered     psychological trauma following natural disasters and violent conflicts. In these     circumstances, TFT can be used as a stand-alone therapy, or as an adjunct to other     psychological therapies, by removing the pain of re-living the traumatic events.      Studies in Rwanda have shown that individuals within a community can be treated with brief     TFT sessions. Both short-term and longer-term improvements in scores of Post-Traumatic Stress     Disorder (PTSD) measurement scales have been demonstrated.      The Kasese District in Uganda has suffered from factional conflicts and the consequences of     the ongoing struggles in neighbouring countries for many years. Although the government has     controlled the situation and secured the borders, many are still haunted by the psychological     consequences.      The purpose of the study is to validate the model of addressing widespread psychological     trauma following conflict by training community leaders to help others in their community     using TFT.      Thirty-six community leaders will be given a two-day training in algorithm level     trauma-relief TFT. They will then treat 128 volunteers for their traumas, using TFT, who will     be assessed before and one week after treatment by the post-traumatic stress disorder     check-list questionnaire for civilians (PCL-C). As a control, a further 128 volunteers will     join a wait-list group, who will be assessed at the same time, but treated later.      PCL-C scores before and after treatment will be compared with the wait-list group scores     before and after waiting, but before their treatment.      A follow-up assessment of the participants will be undertaken 1 to 2 years later.   "
122570|NCT01681615|"     The investigators want to find new challenge test for Acetylsalicylic hypersensitivity /     Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient     as the already established protocols in terms of sensitivity and specificity.   "
122697|NCT01679964|"     Switching from the ritonavir-boosted protease inhibitor component to raltegravir in stable     HIV-infected adult patients receiving combination therapy will demonstrate improved clinical     tolerability or lipid profiles with sustained plasma virological response (<50 copies/ml).   "
122571|NCT01681602|"     Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only     temporarily slow down progression.      Exercise has the potential to improve cognition, psychological symptoms, physical performance     and quality of life, but evidence is scarce. Previous trials are short, often underpowered     and involving home based light exercise programs. Most have included nursing homes residents     with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise     is effective in improving cognition, physical performance and quality of life as well as     reducing the prevalence of psychological symptoms among AD patients.      Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on     power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90     years with mild to moderate AD. The participants will be randomly allocated into two groups:     An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise     1 hour three times a week and a control group only receiving usual care. The hypothesis is     that aerobic exercise will improve physical function, the cognitive and daily functioning and     quality of life in people with mild to moderate AS.      Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup     of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural     changes and β-amyloid accumulation.      Further, a health-economic analysis will be performed.      Recruitment was started in January 2012. Last study visits are planned to be performed in     January 2014 and results will be available in 2014. This RCT will contribute to evidence     regarding the potential effects of a systematic program of physical exercise for patients     with Alzheimer's disease.   "
122572|NCT01681589|"     The purpose of this pilot study is to investigate the relationship between attention and     emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the     cognitive mechanisms of emotional processing in patients with TBI, and explore novel     treatment strategies to improve emotional regulation using with transcranial direct current     stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.   "
122573|NCT01681576|"     This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and     blood pressure in salt-sensitive Asian hypertensive patients.   "
122574|NCT01681563|"     This is a phase II multicenter, non-comparative, open label study in older previously     untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the     efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination     with Ofatumumab (PCO).   "
122609|NCT01681108|"     The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for     children and adolescents to lose weight and promote their self esteem in a fun atmosphere.   "
122575|NCT01681550|"     The use of dipeptidyl-peptidase 4 (DPP-4) inhibitors and glucagon like peptide 1 (GLP1)     analogues for the treatment of diabetic mellitus (DM) type 2 is growing (1,2). Currently,     some of these agents have been approved in combination with insulin. The potential for     combined use with insulin has garnered increasing attention due to reduce side effects     associated with insulin therapy and improve glycemic control. Some investigators reported     that GLP-1 analogue combined with insulin reduces HbA1c and weight with low risk of     hypoglycemia and high treatment satisfaction (3). However, their duration of treatment was     short time with less than a mean of 3.0 years and the alterations of chronic diabetic     complications by combination with incretin-based and insulin therapies are not known.      We evaluated the long effects of adding incretin-based therapy (DPP-4 inhibitors or GLP-1     analogues) to insulin therapy on glycated hemoglobin (HbA1c) as glycemic control, body mass     index (BMI), blood pressure (BP), insulin dosage, frequency of hypoglycemia, and chronic     diabetic complications for 5 years-treatments.   "
122576|NCT01681537|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational combination of drugs. Phase I studies also try to define the appropriate     dose of the investigational combination of drugs to use for further studies.     Investigational means that the combination of drugs is still being studied and that     research doctors are trying to find out more about it. It also means that the FDA has not     approved this combination of drugs for AML. As part of this research study, you will take     lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are     commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with     multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered     investigational in this research study because it is not approved by the FDA for patients     with AML.      Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or     IMID. This drug is successful in the treatment of patients with multiple myeloma and some     patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that     lenalidomide may also be effective in patients with AML. Since we know that many patients who     receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia),     we are studying the addition of lenalidomide to MEC.      In this research study, we are looking for the highest dose of lenalidomide that can be given     safely with MEC.   "
122577|NCT01681524|"     The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to     determine if the study drug in PET imaging is better than SPECT imaging currently used for     this purpose.   "
122578|NCT01681511|"     The primary objective of this pilot study is to demonstrate the feasibility of recruiting     eligible patients for the purposes of assessing the temporal aspects and rates of Catheter     Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that     the numbers needed for a pivotal study can be better estimated.   "
122579|NCT01681498|"     This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the     feasibility of extracting fECGs in a volunteer population.   "
122599|NCT01681238|"     There is growing evidence that the risk of postoperative complications can be decreased by     optimizing the amount and type of infusion fluids given during surgery, steered by     goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk     patients. This study is undertaken subsequently to test the hypothesis that the     intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor,     can partially prevented postoperative complications and shorten hospital stay in the elderly     high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .   "
122580|NCT01681485|"     Lung cancer has been the leading cancer worldwide, which can be divided into small cell lung     cancer (SCLC) and non-small cell lung cancer (NSCLC) based on biology, therapy, and     prognosis. NSCLC accounts for more than 85% of all lung cancer cases and has a poor prognosis     with only 15% of all lung cancer patients alive 5 years or more after diagnosis.      Traditional Chinese medicine (TCM) originated from Chinese philosophy is a different medical     system from conventional western medicine. It focuses on health maintenance and emphasizes on     harmonizing the imbalance of body. Current studies show that TCM has the advantages of     increasing the sensitivity of chemo- and radio-therapeutics, reducing the side effects and     chemo- and radio-therapeutics associated complications, improving patients' quality of life     and survival time. However, how TCM can work with conventional medicine for the treatment of     carcinoma is still an important research topic worldwide. Syndrome, the essential concept in     TCM theory, is a diagnostic conclusion of the pathological changes at a certain stage of a     disease, including the location, cause, and nature as well as the trend of development.      This study aims to investigate the distribution of TCM syndromes, the changing pattern among     NSCLC patients before and after having surgery, chemotherapy and radiation therapy, and the     correlations with patient quality of life and progression free survival. The results are     important for establishing guidelines for TCM practice and research in future.   "
122581|NCT01681472|"     The purpose of this study is to compare the concentration of [6R] 5,10-methylene-THF,     5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients     with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®)     respectively (60 and 200 mg/m2).   "
122582|NCT01681459|"     In lean subjects, free fatty acid (FFA) promotes gut hormone release, delays gastric     emptying, and reduces appetite and energy intake more than an isocaloric load of triglyceride     (TG). In obesity, the gastrointestinal sensitivity to food components may be reduced. In this     study, the investigators compare the effects of the FFA oleic acid and the TG olive oil on     gut hormone secretion, gastric emptying, appetite sensation, and subsequent energy intake in     lean and severely obese subjects.   "
122583|NCT01681446|"     The purpose of the study is to determine whether interferon-alpha is effective in the     treatment of low miR-26 expression patients with HCC after curative resection.   "
122584|NCT01681433|"     This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to     continuing abiraterone acetate and prednisone treatment in men with metastatic     castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA)     progression   "
122585|NCT01681420|"     Conduct a randomized controlled trial (RCT) to test the hypothesis that offering     client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the     risk of HIV contamination in the blood supply and also increase appropriate referrals to     preventive and care services to persons in need in São Paulo, Brazil.   "
122610|NCT01681095|"     The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold     cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic     arrest.   "
122707|NCT01679834|"     This multicenter, observational study will assess the efficacy and the safety of Pegasys     (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C.     Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local     guidelines. Data will be collected for 96 weeks.   "
122586|NCT01681407|"     A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in     depressive patients, treated with SSRI medications. It is an observational clinical     bio-markers laboratory controlled research with no device.      The research includes two groups; one for patients diagnosed of having depression, and will     get a standard SSRI medication regimen. Second group is for control subjects without     depression. An option for a third group is planned to include first degree relatives of the     depressed patients. After giving their informed consents, subjects and patients will go     through standard clinical psychiatric interview, and routine clinical lab tests. Clinical     standard, specific depression and anxiety questionnaires will be held at four follow-up     meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked     to give blood samples at these points of time for the lab processing: Complete plasma     proteomics and specific micro-RNA levels.   "
122587|NCT01681394|"     It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce     blood pressure. However, the mechanisms implicated in these effects have not been elucidated     yet. The purpose of this study is to evaluate changes in gene expression induced by the     administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells     (PBMC) in humans.   "
122588|NCT01681381|"     This is a prospective, multi-center, open label, randomized study to evaluate the efficacy     and safety of The TIVOLI Biodegradable polymer Rapamycin-Eluting Stent comparing with The     FIREBIRD2™ Rapamycin-eluting Stent (DES) for Treatment Coronary Revascularization.   "
122589|NCT01681368|"     Background:      - Birinapant is an experimental cancer treatment drug. It removes certain proteins in cells,     which helps to kill the cells. The drug is more likely to cause the death of cancer cells     than normal cells because cancer cells have more of these proteins. Studies suggest that it     can help treat ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.     Researchers want to see how well Birinapant works against the three types of cancer.      Objectives:      - To test the effectiveness of Birinapant for ovarian, primary peritoneal, or fallopian tube     cancer.      Eligibility:      - Women at least 18 years of age who have ovarian, primary peritoneal, or fallopian tube     cancer that has not responded to standard treatment.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will also be collected. Tumor tissue samples may be collected before treatment.          Imaging studies will also be performed.        -  Participants will have an infusion of Birinapant once per week for 3 weeks in a row,          followed by a break for a week on the fourth week. This 4-week schedule is one cycle of          treatment.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Another optional tumor biopsy will be collected 6 weeks after the start of treatment.        -  Treatment will continue as long as the cancer does not grow and the side effects are not          severe.   "
122590|NCT01681355|"     This study is initiated to investigate the gastrointestinal tolerance of a new infant formula     in healthy, term, Asian infants.   "
122591|NCT01681342|"     Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment     for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a     combination of external beam radiation therapy and intracavitary treatment. Low dose rate     intracavitary brachytherapy treatment is already well studied. But high dose rate     brachytherapy is a relatively new alternative.      In brachytherapy, major developments have been made in the integration of 3D imaging and     computerized 3D treatment planning. Medical imaging improvements allowed for better     definition of tumoral volumes and organs at risk.      The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of     these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of     volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis,     small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix     cancer. However its use is not easy in many brachytherapy departments.      This study will evaluate the feasibility and sparing of organs at risk for high dose rate     brachytherapy if volume delineation is done at each of the two sessions performed with 3D     RMN.   "
122592|NCT01681329|"     Generalized Anxiety Disorder (GAD) is a condition characterized by chronic and excessive     worry and anxiety. Our group has developed a cognitive-behavioural treatment (CBT) for GAD     that has been tested in four previous clinical trials. The findings show that 60 to 70% of     affected individuals attain GAD remission and that 50 to 55% achieve high endstate     functioning following the treatment. Although these numbers are encouraging, there remain a     considerable proportion of individuals who do not fully benefit from treatment. In our most     recent CIHR-funded treatment study, we assessed the impact of information processing on the     efficacy of CBT for GAD. Our findings show: a) that the tendency to negatively interpret     ambiguous information at pre-treatment was associated with greater GAD symptoms at     post-treatment; and b) that patients who were less successful at changing their negative     interpretation style were also less responsive to CBT. Given that computerized interpretation     modification training has been shown to be effective for decreasing the negative     interpretation style of anxious individuals, the goal of the current proposal is to determine     whether such training can augment the efficacy of CBT for adults with GAD. A total of 138     individuals with a primary diagnosis of GAD will be randomly allocated to one of two     conditions: a) CBT plus interpretation modification training or b) CBT plus non-active     training. CBT will consist of 14 weekly sessions, with interpretation modification training     (or non-active training) administered prior to each session. Measures of GAD symptoms,     psychopathology, cognitive vulnerability, and interpretation style will be administered at     pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study     will provide information about the efficacy, clinical usefulness, and mechanisms of     interpretation modification training in combination with CBT.   "
122593|NCT01681316|"     The purpose of this study is to evaluate the effect of Danhong Injection on the relief of     angina with the use of the Seattle Angina Questionnaire among patients with stable angina     patients   "
122611|NCT01681082|"     The general purpose of this study is to examine the effect of tai chi training on cognitive     function in young adults. The investigators will test subjects enrolled in a semester-long     tai chi course along with control subjects. The specific aims are to measure duration of     practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder     (ADHD) indicators. The investigators primary hypotheses are that, compared to controls,     subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b)     response inhibition. The investigators secondary hypotheses are that, among the subjects     participating in the tai chi course, these cognitive improvements will correlate with (2a)     improvements in balance and (2b) duration of tai chi practice, and that, among all     participants, (2c) ADHD indications will correlate with cognitive measures.   "
122612|NCT01681069|"     Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the     subjects' body weight, body fat and safety parameters are monitored   "
122594|NCT01681303|"     Recent research work has directed especial attention toward a distinct group of uremic     retension molecules, called protein-bound uremic toxins. The prototypes of this group of     uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of     free radical and impair antioxidant system and exerts direct toxicity on different cells and     organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these     protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of     kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic     patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular     mortality.      AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has     superior adsorption ability for certain small-molecular weight organic compounds known to     accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of     AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was     reported that AST-120 suppressed the increase in serum creatinine levels, prevented     proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis     therapy.      Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized     AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the     morbidity- mortality of CKD patients.      The principal aim of this prospective cohort study is to investigate the effectiveness of     AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of     this relationship can help to establish new therapeutic strategy in the treatment of     late-stage CKD patients.   "
122595|NCT01681290|"     The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated     synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type     1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy     (DPN).   "
122596|NCT01681277|"     The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics     of multiple rising doses of BI 113608 in healthy male volunteers   "
122597|NCT01681264|"     Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.   "
122598|NCT01681251|"     The management and delivery of intravenous fluids during surgical operations is one of the     important duties for anesthesiologists.      The goal of this study was to determine if goal directed fluid therapy, titrated using the     FloTrac monitor's measurement of stroke volume variation results in a decrease in the length     of stay of patients undergoing open abdominal aneurysm repair.   "
122600|NCT01681225|"     This phase II multi-centered, randomized controlled trial of mechanical ventilation directed     by esophageal pressure measurement will test the primary hypothesis that using a strategy of     maintaining a minimal but positive transpulmonary pressure (Ptp = airway pressure minus     pleural pressure) throughout the ventilatory cycle will lead to an improvement in patient     survival.   "
122603|NCT01681186|"     This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the     safety and side effects of LY2940680 in healthy people. Part A will involve two groups of     participants, each taking up to two single doses of LY2940680 at different dose levels. There     is a minimum 14 day washout period between each of the participant's doses. The purpose of     Part B is to study how much of the study drug, in capsule or tablet form, gets into the     bloodstream and how long the body takes to get rid of it. In addition, the effect of food and     a proton pump inhibitor on LY2940680 will be studied. Part B will involve one group of     participants who will take four single doses of 100 mg LY2940680. There is a minimum 7 day     washout period between doses. Participants may only enroll in one part. Screening is required     within 28 days prior to the start of the study.   "
122604|NCT01681173|"     High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes     and cardiovascular events in prospective observation studies. Our primary objective is to     compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble     fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with     impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention     will be used as independent controls. Secondary aims are to identify mechanisms of action     with regard to body composition, anti-inflammatory and metabolic effects of fibers. We     propose a randomized, prospective intervention study. The results will be of general     relevance for guidance of fiber intake in the population and will help the food industry to     design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased     fiber intake may therefore provide a simple non-cognitive prevention strategy effective at     the population level.   "
122605|NCT01681160|"     This study was a Kind of clinical trial with equal randomization, that have been done from     January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128     diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is     one of the more important aims for health professional specially for nurses.One of this new     treatment is maggot therapy.   "
122606|NCT01681147|"     The purpose of this study is to find out whether women who have had gestational diabetes will     make healthier lifestyle choices, achieve weight goals, and complete postpartum care     assessments after receiving two online classes on healthy nutrition and exercise classes at 6     weeks - 3 months and at 9 months postpartum.   "
122607|NCT01681134|"     The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects     (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.   "
122614|NCT01681043|"     Sleep investigation in respirator treated ICU patients: the importance of intensive     environment.      Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and     increased mortality.      The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise,     light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep     quality in respirator treated ICU patients.      Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc.     AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary     circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m.     after randomization.   "
122615|NCT01681030|"     This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of     EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture     line bleeding in cardiovascular surgery.   "
122616|NCT01681017|"     The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality     (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth     attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn     Care (ENC) curricula. These facilities are located within clusters in the Global Network for     Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret,     Kenya.   "
122617|NCT01681004|"     The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis     (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of     the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo     specific, targeted non-surgical treatment of the SI joint.   "
122618|NCT01680991|"     This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety     of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+)     malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated     time on study treatment is 24 weeks.   "
122619|NCT01680978|"     A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to     assess the effect of aleglitazar on cardiac energetics and function in patients with     uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are     drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg     aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients     will cross over to the treatment not yet received.   "
122621|NCT01680952|"     This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) +     Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil     in Kidney Transplant Patients.   "
122622|NCT01680939|"     Every year thousands of young children with obstructive sleep apnea undergo surgery which     requires them to be prescribed pain medication. The current standard in North America is     administration of opioids, mainly codeine or morphine; however in many areas of the world     including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some     North American surgeons are uncertain regarding the potential of ibuprofen to increase     bleeding following surgery. The results of research studies have been inconclusive overall.     Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been     removed from the formulary at many Pediatric institutions. Some surgeons have begun to use     oral morphine as an alternate to codeine, which necessitates the need to find safe     alternative analgesics in this treatment group.      The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine     and ibuprofen in children with sleep apnea.      An interim analysis will be conducted after recruitment of 70 patients, to monitor both     safety and efficacy   "
124864|NCT01651312|"     The study aims to assess the routes and the extent of metabolism and excretion of YM178 after     a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male     volunteers.   "
122623|NCT01680926|"     Overweight patients with type 2 diabetes are often being treated with an intensified insulin     therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not     achieve satisfying metabolic control. A new therapy option is necessary that makes it     possible to lower the daily insulin requirement and to improve metabolic control. The aim of     this study was to investigate whether a protein-rich meal replacement is suitable to lower     the daily insulin requirement and to reduce HbA1c and body weight.   "
122624|NCT01680913|"     Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In     obese patients, the commonly used landmarks may be difficult or even impossible to feel. In     addition, the spine can be hidden beneath a layer of fatty tissue.      Ultrasound is useful for finding the correct injection site in pregnant patients, but the     usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The     potential benefits for obese patients from the use of ultrasound include shortening the     duration of the procedure, increasing patient comfort, decreasing the total number of     attempts, and aiding in the choice of appropriate needle length for the patient.      The investigators hypothesize that there is no difference in time to perform a spinal     anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients     with BMI > 35.   "
122625|NCT01680900|"     This is a pilot study to determine proof in principle that vilazodone, a selective serotonin     reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot     flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related     quality of life.   "
122626|NCT01680887|"     This is a double-blind placebo-controlled clinical trial (n = 200) of varenicline for the     treatment of cocaine dependence that utilizes contingency management to promote treatment     attendance.   "
122627|NCT01680874|"     The purpose of this study is to determine whether a probiotic, when used together with     standard treatment, is effective in reducing duration of symptoms and preventing recurrence     of infection in older adults with a first episode of C. difficile infection.   "
122708|NCT01679821|"     It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State     University of West of Parana's dental students with natural dentition, in patients with     removable partial dentures and double complete dentures.   "
135091|NCT01516606|"     This is a prospective, phase II study on the activity and tolerability of high dose (2 g/day)     oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone     lymphoma.   "
122628|NCT01680861|"     A recent therapeutic strategy following renal transplantation includes simultaneous use of     reduced calcineurin inhibitor (CNI) dosing and maximized use of a non-nephrotoxic,     antiproliferative drug (inosine monophosphate dehydrogenase (IMPDH) or TOR inhibitor), with     the goals of reducing/avoiding CNI nephrotoxicity, the incidence of acute rejection, and     chronic allograft injury (CAI) (i.e., interstitial fibrosis/tubular atrophy), leading to more     favorable longer-term patient and graft survival.1-7 Early corticosteroid withdrawal has also     been used in the attempt to avoid well-known side effects while maintaining favorable patient     and graft survival.8-10 While the investigators center and numerous other centers have also     included single agent, antibody induction utilizing the lymphodepleting polyclonal antibody     rabbit anti-human thymocyte globulin (ATG), nondepleting human anti-interleukin-2 receptor     (CD25) monoclonal antibody daclizumab (Dac) or basiliximab, or lymphodepleting humanized     anti-CD52 monoclonal antibody alemtuzumab,11-17 evidence now suggests that an even more     effective induction strategy may include the combined use of more than one induction agent     (each with fewer doses than if used alone), with the goal of bringing the kidney transplant     recipient even closer (through more effectively timed lymphodepletion) to an optimally     immunosuppressed state, allowing further reduction in long-term maintenance drug dosing.18-25     The investigators have now successfully used dual ATG/Dac induction therapy in both     kidney-alone23-24 and simultaneous kidney-pancreas (SPK) transplantation,18-20 and a recent     report from the investigators center of kidney-alone and SPK recipients shows that the     addition of anti-CD25 to ATG for induction therapy more effectively delays the return of     peripheral blood CD25+ cells.25 In the kidney-alone recipient study 3 doses of ATG were     combined with 2 doses of Dac for induction,23-24 vs. the investigators previous studies     utilizing single agent induction with 7 doses of ATG or 5 doses of Dac.4,16,17 Successful     combination of ATG/basiliximab as dual induction in kidney transplantation has also been     reported elsewhere,21-22 along with equivalency in clinical outcomes using daclizumab vs.     basiliximab.13   "
122629|NCT01680848|"     The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for     diagnosis, treatment, and prevention of dental caries.   "
122630|NCT01680835|"     This post-approval study is designed to confirm the long-term safety and effectiveness of the     EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial     femoral artery (SFA) and proximal popliteal arteries.   "
122631|NCT01680822|"     Little is known about the disease caused by the nontuberculous or environmental mycobacteria     (NTM) and only limited data are available showing treatment outcome. This project will study     the patients with nontuberculous mycobacterial (NTM) diseases in the University of Illinois     Hospital & Health Sciences System (UIMC). The aim of study is finding treatment outcome and     risk factors that are associated with treatment failure in NTM patients. This is a     retrospective, observational study for collecting data on patients with NTM in UIMC. The     study initially involves populating the study of NTM patients seen at UIMC during the study     period. This will add our knowledge about current treatment outcome of patients with NTM     diseases and will be of interest to physicians, and public health authorities.   "
122632|NCT01680809|"     This study seeks to determine if compliance with compression therapy is increased in patients     with healed venous insufficiency ulcerations when lower levels of compression therapy are     prescribed. This study will measure compliance with compression therapy at low levels of     compression. It will also seek to determine if compression therapy aids in the prevention of     venous insufficiency ulcer recurrence.   "
122633|NCT01680796|"     This is an open-label phase I study in which dovitinib is given in combination with     bortezomib and dexamethasone. Dovitinib dose escalation is planned in order to determine its     maximum tolerated dose when given in this combination.   "
122634|NCT01680783|"     The objective of our study is to evaluate the efficacy of helmet ventilation as compared with     Face mask in patients with respiratory failure.   "
122635|NCT01680770|"     The objective of our study is to determine the correlation of transthoracic ultrasonographic     indices of fluid responsiveness to changes in direct measures of cardiac output and to     compare them to other established predictors of fluid responsiveness such as central venous     pressure variation, systolic arterial pressure variation and pulse pressure variation in a     broad population of patients.      Hypothesis: There will be a significant difference in the inferior vena cava respiratory     variation and subclavian vein respiratory variation between responders and non-responders to     intravenous fluid challenge in a broad population of patients with shock.   "
122636|NCT01680757|"     This study is a prospective, multicenter, non‐randomized trial of a stand‐alone procedure for     left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic     events who are contraindicated for or intolerant of oral anticoagulation therapy. This study     will enroll 100 participant, who will receive the LAA ligation study treatment. The objective     of this registry is to assess the effectiveness of permanent exclusion of the LAA using the     LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard     anticoagulation therapy. The results of the study will be used to assess outcomes within the     first year, post‐treatment.   "
122637|NCT01680744|"     To protect kidney function during the transplantation process by inducing mild hypothermia in     the deceased organ donor before organs are recovered   "
122638|NCT01680731|"     The purpose of this study is to investigate of the differences in pelvic floor anatomy and     function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a     forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women     within 1-5 years after first delivery who did not have an internal delivery will be included.     The total number of subjects is forty. This will include ten primiparous subjects who have     undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous     vaginal delivery and ten who have undergone primary elective cesarean section.   "
122647|NCT01680614|"     The purpose of this research is to examine the effectiveness of computerized alcohol     screening and brief intervention in the UC Irvine Medical Center Emergency Department (ED)     and Trauma Patients. Brief interventions have a high potential impact in ED and Trauma     populations. Computerized alcohol screening and brief intervention (CASI) is a fast and easy     to use tool for patients and healthcare providers. CASI mitigates barriers to proper     screening and intervention, including time, availability of trained personnel, patient     comfort, and language barriers. CASI provides the Alcohol Use Disorders Identification Test     (AUDIT) followed by a brief intervention and customized alcohol intake recomendations for the     patient.      The intervention of this study will be the addition of a brief CASI questionnaire to the     standard of care for a random subset of subjects. All subjects who screen positive for     hazardous alcohol use will be followed up and reassessed for alcohol use. The researchers     hypothesize that the addition of CASI will lead to a decrease in alcohol intake within three     months. The basis of this research is evidence of the effectiveness in the CASI system, the     growing public health issue of alcohol abuse, the need to be able to provide effective     screening and brief intervention in the high volume ED settings, and findings that the     primary method to reduce traumatic death is prevention.   "
122639|NCT01680718|"     It has long been established that interpersonal relationships can have a profound impact on     health and well-being. Yet, we are still learning about the complex biological processes that     contribute to positive social interactions and the ability to develop and maintain social     relationships. Recent research has begun to focus on oxytocin and vasopressin, neuropeptides     that are naturally produced in the hypothalamus, because administration of these     neuropeptides has been associated with increased trust, generosity, empathy, cooperation,     memory of social stimuli (e.g., faces), and brain activity in neural regions associated with     social and emotional processes. To date, several aspects of oxytocin and vasopressin's     effects on social behavior have been unexplored. As such, the overarching goal of this     project is to examine the effects of intranasal oxytocin and vasopressin on social working     memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic     behavior. Understanding how oxytocin and vasopressin influence these aspects of social     functioning will help to inform research that has begun to establish the potential for use of     these neuropeptides in psychiatric disorders such as autism spectrum disorders and     schizophrenia that are characterized by social deficits. For this study, we will recruit 150     healthy adults without a history of medical or psychiatric illness to come to the laboratory.     In the first session, participants will complete several questionnaires. In the second     session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo.     The study nurses will measure temperature, heart rate, and blood pressure (female     participants will also be asked to undergo a pregnancy test) before drug administration.     Participants will then complete computer tasks. During the second session, we will also     collect a saliva sample for genetic analysis and participants will be asked to complete     several additional questionnaires. At the end of the experimental session, participants will     be fully debriefed.      The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will     improve social working memory and deception detection, and increase empathy and altruism. It     is also hypothesized that main effects will not be found for oxytocin or vasopressin, but     rather, analyses of relevant moderators will elucidate these findings.   "
122640|NCT01680705|"     The aim of this study is to determine what the ideal frequency of high-volume sinonasal     saline irrigation in the early postoperative period following ESS for medically refractory     CRS. We will evaluate once, twice, and three times daily frequency sinonasal saline     irrigation protocols. Our hypothesis is that three times a day sinonasal saline irrigations     for the first week is ideal with no difference between frequencies after 1 week.   "
122641|NCT01680692|"     The purpose of this study is to evaluate whether a new regional anesthesia technique would     provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot     drop after knee replacement surgery.   "
122642|NCT01680679|"     Influenza viruses are significant causes of human illness and death in developed and     developing countries. This study will measure the ability of influenza vaccine given to     children in India to protect both the children and unimmunized persons around them from     influenza. It will also determine whether the best time to immunize in a country like India     that has both summer and winter outbreaks of influenza is in the fall, as is done now, or     whether immunization should be in the spring to protect against influenza infections in the     summer.   "
122643|NCT01680666|"     The investigators hypothesized that, in children undergoing venous cannulation for central     line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in     successful venous cannulation at first attempt compared to landmark guided cannulation.   "
122644|NCT01680653|"     The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced     thanks to overnight blood glucose level testing. The timing of the overnight blood test is     often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events     at camp are occurring. It is also unclear what the most appropriate treatment for nocturnal     hypoglycemia is: simple carbohydrates, or mini-glucagon.      In this study, we will use Continuous Glucose Monitors that will send subject data securely     to a remote computer located in the medical cottage at camp throughout the night. Study staff     will monitor the computer and will intervene on low blood sugar as it occurs in real time. On     half of the nights, campers will receive mini-glucagon for low blood sugar, and on the rest,     they will receive standard carbohydrate treatment.   "
122698|NCT01679951|"     The purpose of this dose range finding study is to assess the effectiveness, safety and     tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients     with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.   "
122645|NCT01680640|"     Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the     liver not caused by alcohol. The liver is an organ that is not designed to build up fat.     NAFLD is common in people who have too much body fat in their abdomen or who have diabetes     (high blood sugar), but does not always exist with these conditions. NAFLD can also occur in     thin people too. NAFLD can be harmful to the liver and may cause the liver to fail over time.     NAFLD may also cause adult (or type 2) diabetes and also heart disease. In people who already     have diabetes, NAFLD can cause glucose (sugar) levels to be too high.      Our intestines (guts) contain healthy bacteria and some harmful bacteria (bugs). This balance     of healthy and harmful bugs is essential for the normal workings of our intestine to digest     food. Providing these bacteria do not leak out into the blood they do not cause harm. If the     balance of healthy to harmful bugs is upset, the harmful can cause problems and leak out into     the blood. Because the liver is connected to the intestine by blood vessels the harmful     bacteria can get to the liver and cause problems. These bacteria can cause the liver and the     body to build up too much fat and might cause NAFLD and obesity. In this study, we will test     the effects of a supplement (synbiotic) taken during the day, that contains a mixture of     'good' healthy bacteria (probiotic) and a sugar (prebiotic) that is not broken down and     absorbed into the blood. We will test whether the synbiotic supplement has beneficial effects     on the NAFLD liver condition and on factors linked to too much body fat, diabetes and heart     disease.   "
122646|NCT01680627|"     The purpose of this research is to examine the effectiveness of the Computerized Alcohol     Screening and Brief Intervention (CASI) in adolescent patients in the Emergency Department at     the UC Irvine Medical Center. This research study will evaluate the effectiveness of the     brief intervention compared to standard of care (no intervention). Brief interventions have a     high potential impact in ED. Computerized alcohol screening and brief intervention (CASI) is     a fast and easy to use tool for patients and healthcare providers. CASI provides the Alcohol     Use Disorders Identification Test (AUDIT-C)4, from the World Health Organization and CRAFFT3,     followed by a brief intervention and customized alcohol intake recommendations for the     patient. This study will also determine the effectiveness of the brief intervention in     reducing alcohol use/abuse in adolescents between 12-17 years of age.      The overall goal of this study is to identify at risk alcohol use/abuse in adolescents and     provide an intervention at an early stage. The current data to support alcohol and screening     and brief intervention in adolescents is limited. The researchers hope that this research     study will add to the overall body of knowledge in support of using the emergency department     as a tool in public health, as it relates to the individual patients morbidity and mortality     (pancreatitis, cirrhosis) and to the societal costs of alcohol use (lost days of work, motor     vehicle collisions).   "
122777|NCT01678924|"     This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia     (PHN).   "
122648|NCT01680601|"     Surgical correction of congenital heart defects in children requires the utilization of     cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions     during surgery. During this process the patient´s circulation is controlled by a bypass     machine which provides several functions:        1. Controls the patient's blood flow by pumping of blood in the patient's body.        2. Controls the correct oxygen levels in the patient's blood.        3. Regulates the temperature and fluid level of the blood. This process triggers negative          responses in the heart and throughout the whole body, potentially resulting in injury to          the heart and other organs such as brain, kidneys and lungs.      Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce     the injury to heart muscle during cardiac surgery. The procedure consists of the inflation of     a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by     briefly reducing blood flow to the leg muscle, which will then activate the body´s own     protective mechanisms and thereby reduce heart injury.      Several animal studies have been used to help the understanding of the mechanisms behind this     process, and trials in human adults have showed optimistic results; however evidence     regarding the paediatric population is limited and necessary since children present different     basal profiles, risks and requirements.      The investigators propose a randomized clinical trial assessing the efficacy of RIPC to     provide protection against injury to the heart and other organs in children going through     cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will     have a translational approach, integrating basic molecular mechanisms to clinical outcome.     The investigators hope it will allow the understanding and utilisation of the patient´s own     protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.   "
122649|NCT01680588|"     This is a phase 2, open-label, multiple-center, non-randomized single dose study to assess     the safety and efficacy of [18F]NAV4694 PET imaging in detecting beta-amyloid plaque in the     brain in subjects with probable AD compared with healthy volunteers.   "
122650|NCT01680575|"     To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia     induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian     cancer and to validate this model.   "
122651|NCT01680562|"     In vivo differentiation of benign and malignant skin lesions is a fundamental issue in     clinical dermatology. Malignant skin diseases are known to be accompanied by structural     alterations. Conventional excisional biopsies and further histopathology are regarded as the     reference standard for investigating these pathologies. Biopsies are invasive procedures and     additionally may cause side effects. Therefore, research efforts are focused on the     development of diagnostic techniques capable of providing in vivo information on the skin's     structure. Optical coherence tomography (OCT) is a technical application, which allows the     identification of microscopic patterns indicative for benign and malignant skin lesions. OCT     is a promising noninvasive imaging technique for the micromorphology of the skin. So far,     it's clinical application, as an additional diagnostic tool for malignant skin lesions has     been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a     prospective pilot study at the Department of Dermatology, Medical University of Vienna. The     study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical     University of Vienna.      A total of 70 malignant skin lesions was evaluated during this prospective pilot study.     Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those based     on the clinical standard pathway at the Department of Dermatology, Medical University of     Vienna. For the purpose of this study, the histopathological diagnosis was used as the     reference diagnostic standard.      The major aims of this study is the investigation of the ability of ultrahigh resolution OCT     to identify fine morphological characteristics associated with basal cell carcinoma, actinic     keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and     melanoma.        -  To correlate the morphologic features identified with ultrahigh resolution OCT with          routine histopathology        -  To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT          technology        -  To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to          diagnose various melanocytic and non-melanocytic skin tumors        -  To compare the diagnostic capabilities of ultrahigh resolution OCT with standard          non-invasive diagnostic procedures such as epiluminescence microscopy   "
122652|NCT01680549|"     The purpose of this project is to study the effects of gabapentin on pain control in the     perioperative and post-operative period of total knee arthroplasty.   "
122701|NCT01679912|"     This clinical trial aims to compare morbidity and cost associated with acute attacks of     hereditary angioedema in patients with an intervention based on a support after a phone call     to the call center (SOS HAE) from a group of patients does not change their practice.   "
122772|NCT01678989|"     Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of     children of BD parents and diagnosed with and BD children whether or not brain has affected     zones. These groups were compared to healthy controls and whether or not the mental health of     children is influenced will be evaluated by the clinical investigation.   "
122653|NCT01680536|"     The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug     maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many     people successfully take only darunavir/ritonavir treatment for their HIV. However, there are     some concerns that this treatment may not reach some areas of the body, such as the brain and     spinal cord (central nervous system or CNS), as effectively as it does the bloodstream.      There is already a large clinical study looking at any differences between 'conventional' HIV     treatment with 3 drugs and single drug treatment with a protease inhibitor, also called PI     monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the     CNS. However, this study will only be finished in 2013.      The investigators know that maraviroc can reach the CNS very effectively. The investigators     in this study will investigate the effect of adding maraviroc to darunavir/ritonavir     monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS,     called cerebrospinal fluid or CSF.      Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in 2     clinical studies when it was taken by people whose HIV virus had developed resistance to     previous HIV treatments.      This study will also investigate safety as well as monitor effectiveness when patients take     maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.      Maraviroc has been shown to be present in the fluid that surrounds the brain in people taking     Maraviroc. It is not known if whether the presence of Maraviroc has any impact on brain     function. Therefore this study will also investigate brain (neurocognitive) functioning with     a computer test and some written tests.   "
122654|NCT01680523|"     To compare 5-year overall survival between patients who undergo radical hysterectomy followed     by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO     stage IB2 and IIA2 cervical cancer   "
122655|NCT01680510|"     Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration     starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding     disease in Israel in 2004 [7% of all blindness]. The investigators treated a non-progressive     form of the disease [Fundus Albipunctatus] by oral therapy of the food supplement made from     alga Dunaliella Bardawil composed of approximately 50% 9-cis β-carotene. The alga Dunaliella     Bardawil accumulates high concentration of β -carotene when grown under appropriate     conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β     carotene and 50% 9-cis β -carotene.      The 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro     in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The night     vision, as measured objectively by electroretinography (ERG) more than doubled in six     patients tested following treatment. The visual field was also improved significantly. In a     more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b     Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial.     Significant improvement in retinal function was recorded in 34% of the patients.   "
122656|NCT01680497|"     A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM     VOLIFT™ for the correction of moderate to severe nasolabial folds   "
122668|NCT01680341|"     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).      The aim of the trial is to compare the efficacy and safety of two different titration     algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes     mellitus previously treated with insulin glargine.   "
122657|NCT01680484|"     There are multiple factors affecting the variability and acceleration pattern of fetal heart     rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any factor     decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be     stimulated by manual manipulation, sound, light, change in maternal position and maternal     ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently     practiced in outpatient settings. This is not only medical but also a social routine. In this     study the investigators have chosen the two most popular so-called 'fetal accelerators',     chocolate and orange juice against no intervention and tried to find any usefulness of these     on non-reactive NST patterns.   "
122658|NCT01680471|"     Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating     airway properties, has acquired widespread acceptance in children. However, sevoflurane has     been reported to be associated with emergence agitation in children, with a reported     incidence of up to 80%.      The purpose of this study is to verify that the prophylactic use of midazolam, which is a     GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces     the incidence of emergence agitation after sevoflurane anesthesia in children.     Simultaneously, this study aims to find out the proper dose of midazolam with minimum     disturbance to patient's emergence time.   "
122659|NCT01680458|"     To collect the efficacy and safety information of fluconazole on infant subjects related to     their appropriate use in daily practice.   "
122660|NCT01680445|"     The telephone interviews will be conducted to gather information on goal setting and goal     attainment from men and women with osteoarthritis.   "
122661|NCT01680432|"     Constipation is a common gastrointestinal motility disorder, chronic condition that often     negatively affects the daily lives of patients due to their symptoms, such as infrequent     stools, hard stools, straining or painful defecation, cramping, bloating and flatulence.     Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to     the onset of constipation. One way to reduce constipation through nutritional management of     affected individuals is through consumption of probiotic products, which beneficially affect     the development of microbial flora in the intestine, helping to improve the symptoms of     constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis,     which according to its maker, when consumed as part of a healthy diet, presents beneficial     effects in improving symptoms of constipation.      Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms     constipation.   "
122731|NCT01679522|"     To compare the feasibility, safety, and efficacy between single-port and four-port     laparoscopic surgical staging in patients with early stage endometrial cancer.   "
122732|NCT01679509|"     To compare the safety and efficacy between single-port and three-port adnexal surgery in     patients with benign ovarian and tubal disease   "
122662|NCT01680419|"     An urgent and growing need exists for interventions that support the long-term adjustment and     mental health needs of OIF/OEF veterans and their relationship partners after the return from     deployment. This project will complete production of a multimedia intervention program for     autonomous use, delivered by Internet and mobile app technology, that teaches couples     selected mind/body interventions and massage techniques to promote stress reduction,     compassion, resiliency and relationship re-integration. A four-armed randomized trial will     evaluate mental health outcomes as a free-standing program and as complementary to a current     standard of care structured group program.   "
122663|NCT01680406|"     The investigators hypothesize that the addition of primaquine (PQ) to both     artemether-lumefantrine (AL) and chloroquine (CQ) for the treatment of Plasmodium vivax     infection will result in decreased chance of relapse by about 60%.      The investigators plan to assess the therapeutic efficacy of AL compared to combined AL + PQ     and CQ compared to combined CQ + PQ against P. vivax infection. They also plan to determine     the number of recurrent vivax episodes in patients receiving PQ compared to those who don't     receive PQ. Patients aged above 1 year with symptomatic malaria presenting to health centers     will be enrolled for treatment with AL, AL+PQ, CQ, or CQ+PQ for P. vivax infection.      Phase 1 of the study will monitor the clinical, parasitological, and hematological parameters     for P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug     efficacy. Phase 2 will continue monthly follow-up of these patients for one year to assess     frequency of recurring vivax infections. Results from this research study will be used to     assist Ethiopia in assessing their current national malaria drug policies.   "
122664|NCT01680393|"     This study is a 3-legged randomized study examining whether during shoulder surgery performed     in the beach chair position active compressions of the lower leg with a sequential     compression device (SCD) have a superior effect on stabilizing cerebral and circulatory     hemodynamics when compared to TED stockings or a control group without any stockings.   "
122665|NCT01680380|"     The purpose of this study is to evaluate the feasibility of tracking breathing during sleep     with non-contact sensors (for example, microphones or wireless movement sensors). The     investigators will use the data collected with these sensors to develop algorithms for     tracking breathing during sleep. The investigators will assess the performance of the     algorithms by comparing automatic output against manually-generated labels.   "
122666|NCT01680367|"     This study is to determine what dressing would work best to heal and keep from hurting, the     split-thickness skin graft donor site which will be done as part of the patient's surgical     procedure. Currently there is a dressing that is transparent and it is placed on the wound     after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the     gauze and elastic bandages are removed and the area is left with the transparent dressing.     Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing     is removed and the wound is left open to air. The dressing researchers are studying is a     dressing that has been used for different types of wounds, as well as this type of wound. It     is applied in the same manner; however, it is left in place until it falls off independently,     usually around post-operative (post-op) day 10.   "
122667|NCT01680354|"     Laser correction for myopia and astigmatism using an excimer laser has been performed with     success for several years.      During the last 2 years, a new method for correction of refractive errors has emerged. In the     method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is     subsequently removed. For simple myopia this method has proved effective and on par with     excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the     treatment of astigmatism.      In the study, patients with high astigmatism are treated with conventional LASIK for     astigmatism in one eye and with ReLEx for astigmatism in the other.   "
122790|NCT01678742|"     The aim of our study is to investigate the effects of high-protein diet on satiety and     incretin hormones in patients with diabetes.   "
122670|NCT01680315|"     The regulation of our food intake is on the short-term guided by appetite and satiety signals     generated by the sight and consumption of food. Food intake is not only regulated by appetite     and satiety signals - external cues also play an important role.      It has been observed that food intake and the pleasure derived from consumption is affected     by manipulation of the external cues.      The investigators will assess the contribution of food anticipation (calorie information) and     actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin     responses, appetite and subsequent food intake). The investigators expect the information on     the amount of calories, rather than the actual amount of calories in the food, to predict the     ghrelin responses and the subsequent intake of a second meal.   "
122671|NCT01680302|"     This is a substudy of Generation 100. In that study, 4000 healthy persons between 70 and 75     will be randomised do moderate intensity, high intensity or control group, with 3 years of     exercise. The investigators will follow these persons and register all who develop atrial     fibrillation during these 3 years, and at follow-up after ended intervention to see if there     is differences in the number of persons who develop atrial fibrillation in the 3 groups.   "
122672|NCT01680289|"     The aim of this study is to determinate the influence of an alternative adhesive application     protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in     primary molars.   "
122699|NCT01679938|"     The overall objective is to determine the impact of comprehensive, multifaceted, child     care-based intervention to prevent obesity among children 2 through 5 years of age. The     specific aims are:        1. To determine the extent to which the intervention, compared with the control condition,          results in a smaller age-associated increase in body mass index (BMI) after a 6-month          intervention (primary outcome) and a 1-year follow-up period among children.        2. To determine the extent to which the intervention, compared with the control condition,          reduces the proportion of children who are obese (BMI >95th percentile for age and sex).        3. To determine the extent to which the intervention, compared with the control condition,          results in:             1. improved dietary, physical activity and television-viewing behaviors among               children, specifically, reducing the consumption of sugar-sweetened beverages, high               calorie/low nutrient-dense snack foods, and fast food, increasing active time, and               reducing TV/video viewing time;             2. improved home food and activity environment, specifically, decreasing availability               of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and               increasing parental support for healthy eating and regular physical activity;             3. improved child care center food and activity environment, specifically, increasing               opportunities for healthy eating and physical activity, and increasing support and               encouragement of children's behavior change by child care providers;        4. To assess the feasibility and acceptability of the intervention among child care          providers and families.      METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS     child care centers in Mexico City. The investigators will randomly assign 8 child care     centers to the intervention condition and 8 to an assessment-only control condition.      Multifaceted intervention. The resulting intervention will involve four main components:        1. Training of child care providers.        2. Curriculum sessions for children.        3. Family outreach activities.        4. Maintenance activities. Outcome and process measurements. Age-associated BMI (child's),          changes in child's key obesity-related behaviors, changes in the child's home food and          activity environment, and changes in child care food and activity environment. At the          intervention and control child care sites, changes from baseline to one year for all          outcome variables will be measured.   "
122673|NCT01680276|"     Many people with intellectual disability have challenging behaviour which often has serious     consequences such as the prescription of long term medication, in-patient admissions and     disruption of normal daily activities. Community intellectual disability services may have     difficulties in helping people with challenging behavior. Available research suggests that     Positive Behavior Support (PBS), a training system that teaches staff how to manage these     situations, can benefit service users who may show improvements in challenging behavior and     quality of life. The investigators do not know of any study so far that has examined the     clinical and cost effectiveness of PBS that is provided by staff in routine clinical practice     in community intellectual disability services. If PBS proved to be better than treatment as     usual, it would have important implications for the management of a very vulnerable group of     service users. In this trial, health staff will receive accredited training in PBS available     in a manual written by PBS experts. It will give details of how to understand challenging     behavior and develop a management plan and how to implement it and monitor whether it has     achieved its goals. Twenty community intellectual disability services and 260 service users     with mild to severe intellectual disability and challenging behavior will be invited to take     part in the study. The sample size calculations are based on our pilot study and allow for     non participation of 10% and inflation due to the number of community intellectual disability     teams and staff that will take part. The teams will be randomly allocated into one of two     conditions. Half will be in the PBS arm (but will also have treatment as usual) and half will     be in the treatment as usual only group. The investigators will carry out assessments of     challenging behavior, use of services, quality of life, mental health, aggression and family     and paid carer burden at six and 12 months. The investigators will monitor treatment fidelity     and the investigators will talk to a sample of paid and family carers, service users, staff     and managers about what they think of the treatment and how best the investigators can     deliver it in routine care. The main outcome is reduction in challenging behavior at one year     after the randomization. The investigators will also carry out a health economic evaluation     to examine the costs and consequences of staff training in PBS.   "
122674|NCT01680263|"     The aim of this study was to determine the effects of kinesiotaping in comparison to NSAIDs     and physical therapy in treatment of pes anserinus tendino-bursitis.   "
122675|NCT01680250|"     The purpose of this study is to evaluate the effectiveness and safety of Sirolimus in     reducing liver volume in autosomal dominant polycystic kidney disease.   "
122676|NCT01680237|"     Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety     disorders. Although the efficacy of psychological treatment for panic disorder with     agoraphobia has been the subject of a great deal of research, studies comparing     cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect     small to moderate differences. Therefore, the primary purpose of the present study is to     investigate if the combination of cognitive techniques with exposure in vivo is superior to     the effects of exposure alone for patients with moderate to severe agoraphobia.   "
122677|NCT01680224|"     Obesity is a major US public health problem. Few obesity prevention programs have reduced     risk for weight gain over follow-up and those that have are very intensive, making     dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy     Weight) targeting young adults with body dissatisfaction involving participant-driven healthy     dietary and physical activity lifestyle changes significantly reduced increases in body mass     index (BMI) and obesity onset relative to alternative interventions and assessment-only     controls through 3-yr follow-up, though effects were small in magnitude. To enhance efficacy,     the investigators added dissonance-inducing activities regarding unhealthy dietary and     activity practices, drawing from a highly efficacious dissonance-based eating disorder     prevention program. A pilot trial found that this new Project Health intervention     significantly reduced increases in BMI relative to both the Healthy Weight intervention and     an educational brochure condition from pre to post. The investigators propose to conduct a     rigorous multisite effectiveness trial that will test whether adding the dissonance-induction     elements to the originally Healthy Weight intervention improves weight gain prevention     effects. 360 college students at risk for future weight by virtue of their age and weight     concerns will be randomized one of three conditions: (1) a refined 6-hr group-based     dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight intervention, or (3) a     psychoeducational video (Weight of the World) condition. Participants will complete     assessments of % body fat, mediators (including objectively measured physical activity),     moderators, and other outcomes at pre, post, and 6, 12, and 24 month follow-ups.   "
122678|NCT01680211|"     Objective of this study is to determine the safety and efficacy of administration of herbal     supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks     in the management of prediabetes and mild to moderate hyperlipidemia.   "
122679|NCT01680198|"     The primary aim of this study was to test the hypothesis that Paricalcitol, an active form of     vitamin D, improved endothelial function in stage 3-4 chronic kidney disease (CKD) patients.     A secondary aim of this trial was to study the relationship between endothelial function and     plasma/serum and genetic biomarkers of bone mineral disorders in CKD (BMD-CKD) and renin     angiotensin-aldosteron system (RAS) (angiotensin II and plasma renin activity).   "
122680|NCT01680185|"     The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment     with short acting insulin, applied continuously through an insulin pump, (i) improves     glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers     further β-cell protection, in comparison to the standard of care control group, and the basal     insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented     insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic     events. Patients in the SAPT-NODAT study will be followed through 24 months     post-transplantation.   "
122681|NCT01680172|"     Depression is common in patients with cancer. Current medications for depression, while     effective, take several weeks to take effect. Ketamine has emerged as a drug with promise for     cancer patients. In two reported cases, a single dose of ketamine induced rapid and     moderately sustained symptom reduction in depression and anxiety with no adverse side     effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is a     randomized, double-blind, placebo-controlled investigation testing whether a single dose of     ketamine improves depression and anxiety relative to placebo in patients with cancer.   "
122682|NCT01680159|"     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650     at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the     treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but     decreased thereafter.   "
122700|NCT01679925|"     GnRH agonists are used in the treatment of precocious puberty in order to improve adult     height.However,the psychosocial impact of precocious puberty is often used by the clinician     at diagnosis to justify treatment, but can not yet be properly assessed. It can not be     considered as a rational neither for the indication to treatment, nor to assess its potential     efficacy.      The overall objective of this work is to improve the conditions leading to the therapeutic     decision and the procedures for monitoring girls with idiopathic central precocious puberty.   "
122683|NCT01680146|"     Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a     major impact on our healthcare system due to increased morbidity and greater need for     hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to     improve dietary intake of the elderly. It has already been shown that ingestion of dietary     protein stimulates muscle protein synthesis and inhibits muscle protein breakdown, resulting     in an overall positive net protein balance. However, the impact of fat (as part of the meal)     on dietary protein-induced muscle protein synthesis remains largely unknown. Based on     previous studies by other research groups, we hypothesize that fat further stimulates the     muscle anabolic response to protein ingestion.      Objective: The primary objective of this study is to investigate the effect of a single     meal-like amount of protein with or without fat on postprandial muscle protein synthesis     rates in healthy elderly men. Furthermore, as a secondary objective, we will assess digestion     and absorption kinetics.      Study design: double-blind randomized intervention study Study population: 24 healthy elderly     men (55-85 y) Intervention: one group (n=12) will consume a test beverage of 350 mL     containing 20 g of intrinsically labeled casein, and the other group (n=12) will consume a     beverage of the same volume containing 20 g of casein plus 20 g of fat.      Main study parameters/endpoints: Primary endpoint: muscle protein synthesis rates. Secondary     endpoint: digestion and absorption kinetics.   "
122684|NCT01680133|"     Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent     excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could     play an important role in the development and exacerbating of insulin resistance. Therefore,     the investigators propose to study the regulation of adipose tissue and skeletal muscle     lipolysis, as well as further characterize the intracellular lipolytic pathways within these     tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.   "
122685|NCT01680120|"     Fixation of fractured neck of femur is a common Orthopedic surgery. Anaesthesia can be     challenging in some cases like in haemodynamical unstable patients.      The investigators have evidence of minimum effective local anaesthetic dose (MLAD) in hip     replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is     still unknown.      A step-up/step-down methodology was used successfully in regional anaesthesia and also in     other areas of anaesthesia.      In pregnant ladies in whom spinal anaesthesia is performed on the side, significant     correlation exist between the vertebral length measured from cervical 7 to the iliac creast     and MLAD.      The investigators aim it was to determine the MLAD of hyperbaric 0.5% bupivacaine required     for Continuous spinal anaesthesia for the operative fixation of FNF.   "
122686|NCT01680107|"     The purpose of this study is to determine whether d-cycloserine augments the clinical effects     of exposure-based cognitive-behaviour therapy for panic disorder.   "
122687|NCT01680094|"     The purpose of this study is to assess the safety and ability of panobinostat to re-activate     HIV transcription in latently infected CD4+ T-cells among HIV-infected patients on stable     antiretroviral therapy   "
122688|NCT01680081|"     This study was designed as a prospective multicenter trial to determine the accuracy of     combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic     perfusion imaging in patients with suspicious coronary artery disease compared conventional     coronary angiography and quantitative dynamic perfusion MRI as standard reference.   "
122689|NCT01680068|"     Macular hole is a hole formation which takes place in the center of the retina. Such a hole     needs surgical steps in order to close. Closure of the macular hole will lead to a     substantially improvement of vision in most cases. Following macular hole surgery a tamponade     of intraocular gas is normally injected in order to keep the macula dry for the postoperative     period. Postoperative face down position for a week was earlier standard. Several authors     report of good closure rates with both air tamponade or lack of face down positioning. In     this study standard pars plana vitrectomy with peeling of the internal limiting membrane     (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down     positioning will not be used.   "
122690|NCT01680055|"     This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for     the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed     aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine   "
122691|NCT01680042|"     several studies have investigated healing effect of phenytoin.In this study we investigate     healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste     after oral biopsy.   "
122692|NCT01680029|"     To evaluate the performance and safety of the PBASE-system when used in the treatment of     acute migraine episodes of moderate to severe intensity. The study will evaluate the effect     of treatment on migraine pain and symptoms during an acute attack and also any long-term     effect.   "
122693|NCT01680016|"     This study was designed to evaluate the safety and immunogenicity of two simulated     postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese     children and older adults.   "
122694|NCT01680003|"     This is a multi-center, double blind, parallel group placebo controlled randomised trial     designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri     (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a     treatment period of 48 weeks   "
122791|NCT01678729|"     To determine the influence of pupil size in refractive surgery. If any influence exist.   "
122695|NCT01679990|"     The objective of the study is to establish the safety profile of      Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects     comprising of 4 treatment groups:        1. Double treatment of PLX-PAD low dose        2. Double treatment of PLX-PAD high dose        3. Double treatment of Placebo        4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will          receive the assigned treatment twice to the affected leg, within 12-weeks interval          between each treatment.      The study will be comprised of 5 stages:      Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by     additional injection after 12 weeks and with follow-up of 12 months post second injection   "
122696|NCT01679977|"     Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two     different types of training.   "
122702|NCT01679899|"     This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to     compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone     Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.      A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The     active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator,     gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.   "
122703|NCT01679886|"     The main objective of this study will be to compare the diagnostic performances of     82Rubidium-PET associated to pharmacologic stress (Persantine) to 99mTc-Sestamibi-SPECT with     CZT cameras associated to a stress test (exercise, pharmacological, mixed) for detection of     myocardial ischemia in a population of overweighed patients on one hand, and women on the     other hand, in a population with an intermediate prevalence of coronary artery disease (≥ 3     cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the     DIAMOND-FORRESTER score in symptomatic patients).   "
122704|NCT01679873|"     Objective: The aim of this study is to assess the impact of reporting, in abstracts of     randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs)     of the authors on General Practitioners' confidence in the abstracts' conclusions.      Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP). They     will be recruited among residents from the Primary Care department of the Paris Descartes     University and among a GP network who agreed to participate to research studies.      The allocation of participants will be done by a computerized randomization list, the     sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants     will be blind of the hypothesis and of the randomization. Allocation concealment will be     provided because only the statistician will have access to the randomization list.      Methods: Three interventions will be assessed corresponding to three different types of     abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors, 2)     abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs of     authors.      A sample of abstracts will be selected from published randomized trials, testing superiority,     assessing pharmacological treatment, in the field of Primary Care and General Practice and     having a conclusion in favor of the beneficial effect of experimental treatment in terms of     tolerance and / or efficacy. They will then be standardized and modified to obtain three     types of abstracts: 1) with funding sources, 2) with funding sources and COIs and 3) without     either source of funding or COIs.      Participants will be asked to assess one abstract of their randomization arm. Outcome: The     primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be     the quality perception of the study and the interpretation of the benefit of experimental     treatment. Responses will be ranged by a 10-point numeric scale.      Potential interests: This study takes place in the field of Primary Care. We believe that     better understandings of impact of funding sources and conflicts of interests are necessary     to allow more transparency in medical research and in his translation into medical practice.      Sample size expected: 354 participants.   "
122705|NCT01679860|"     Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival     (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation     (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative     conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related     toxicity and mortality. The investigators have recently proved feasibility and potential     efficacy of a RIC regimen in relapsed PTCL patients.      We want to investigate whether it is possible to improve the outcome of alk negative PTCL     pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.      The intensification will be obtained by combining intensive chemotherapy, alemtuzumab     (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years     (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between     61 and 70 years(Clinical Study B).   "
122709|NCT01679808|"     Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy     in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study.     A garden hose was compressed from one side to simulate the posterior wall of the trachea     bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was     increasingly compressed in eight steps. Resistance was measured at each step for airflows 1     l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a     computer to estimate the cross sectional area reduction and the corresponding distance     between the bulging (posterior)and the opposite (anterior) wall (AP-distance).      Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy.     The tracheal obstruction was observed during forced expiration and cough, and the cross     sectional area reduction was estimated using the results from the model study.   "
122710|NCT01679795|"     The aim of this study is to evaluate the vascular effects of tibolone on climateric women     measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound     and compare to placebo.   "
122711|NCT01679782|"     The purpose of this study is to determine whether nervous system alterations and motor drive     failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we     will look after the role of nocturnal hypoxia in these alterations.   "
122712|NCT01679769|"     The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and     radiology methods in patients with chronic hepatitis B in mainland China.   "
122713|NCT01679756|"     The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal     anastomosis (EA) after laparoscopic right hemicolectomy for cancer.   "
122714|NCT01679743|"     Background:      - Brain metastases are cancer cells that have spread to the brain from primary cancers in     other organs. These tumors can be removed surgically. However, researchers are trying to find     better ways to treat brain metastases. A new drug, GRN1005, has been designed to cross into     the brain and deliver the cancer treatment drug paclitaxel to treat tumors. Researchers want     to see how well GRN1005 works on brain metastases from breast or lung cancer.      Objectives:      - To test the safety and effectiveness of GRN1005 in treating brain metastases from breast or     lung cancer.      Eligibility:      - Individuals at least 18 years of age who have breast or lung cancer that has spread to the     brain.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Tumor tissue samples may also be collected. Imaging studies          will also be performed.        -  Participants who have breast cancer will be divided into two groups. Those whose cancer          contains the HER2 protein will be treated with the drug Herceptin as well as GRN1005.          Those without HER2 will have only GRN1005.        -  Participants who have lung cancer will also have only GRN1005.        -  All participants will have two doses of GRN1005, each 3 weeks apart. On the day the          second dose of GRN1005 is given, participants will undergo surgery to remove the brain          tumors.        -  Treatment will be monitored with frequent blood tests and imaging studies.   "
122715|NCT01679730|"     To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome     patients by hydrogen breath test and molecular-based analysis of microbiota in     gastrointestinal tract   "
122716|NCT01679717|"     In this randomized controlled trial the investigators want to investigate whether early     versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a     faster recovery of hand function. The investigators also want to explore patients'     satisfaction with the two different treatment regimes. The participants in the control group     will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in     a splint for six weeks. The participants in the intervention group will use a soft splint for     six weeks, but will be instructed to remove the splint daily to perform exercises for the     thumb. A total of 70 patients will be included in the study.   "
122717|NCT01679704|"     This study is initiated to investigate the glycemic index value of ten food products.   "
122718|NCT01679691|"     Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain     control intra and more importantly post-operative pain. It is a well-known effect of epidural     injections to cause a sympathetic stimulation and consequently vasodilatation in the lower     limb vessels.      Since epidural catheters can cause vasodilatation in lower limb vessels, they can     subsequently lead to increased intra and post-operative bleeding from the surgical wound.      The study will involve all patients having a bone tumor in the lower limb and subjected to     tumor resection and reconstruction by prosthesis.      The patient will be randomized according to the administration of epidural anesthesia into     two arms, an arm in which epidural anesthesia was employed and another arm in which the     patient was subjected only to general anesthesia and the amount of intra and postoperative     bleeding will be compared in both arms.   "
122719|NCT01679678|"     This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety     and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical     control. The study will enroll adult subjects with post traumatic/post surgical, venus     insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be     followed for 12 weeks.   "
122720|NCT01679665|"     Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1     and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good     safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the     candidate vaccine for the phase 3 clinical trial.      This clinical trial is a supplementary phase 2 trial, which is designed to study the gene     expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5     years old use a systems biology approach combined with microarray analysis，RT-PCR and     neutralizing antibody testing for PBMC and serum collected form the studied children     population, to predict immunogenicity, and explore mechanistic insights about the EV71     vaccine.   "
122721|NCT01679652|"     Investigators want investigate the following hypothesis:        1. Nebivolol increases nitric oxide activity in the systemic circulation and the kidney        2. The increased activity of nitric oxide during nebivolol treatment can be demonstrated by          inhibition of NO synthesis with L-NMMA. We expect increased responses in blood pressure          and sodium excretion is expected during nebivolol treatment compared to placebo.   "
122722|NCT01679639|"     This open-label, fixed-sequence, three-period, single group study will evaluate the effects     of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will     receive single doses of aleglitazar in all three periods and single doses of rifampicin in     periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is     up to 14 weeks.   "
122723|NCT01679626|"     In anesthesia, intubation is a technique used to secure an airway. This technique is not     always straightforward. Sometimes it is difficult to place an endotracheal tube. There are     two manners of giving pressure to the patients neck, to improve view and facilitate     intubation.      The investigators hypothesize that by giving this pressure the effective work area is likely     to be smaller. The investigators would like to quantify this effect by measuring the     effective work area, using a specially designed computer program.   "
122724|NCT01679613|"     The objective of the current study is to investigate the relative bioavailability of a single     dose of nintedanib low or high dose with and without coadministration of ketoconazole at     steady state   "
122725|NCT01679600|"     The propose of this study is to evaluate the feasibility and the clinical efficiency of     feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular     rehabilitation early after stroke. The investigators hypothesize that feedback-controlled     RATE might be suitable and effective to improve cardiovascular fitness and functional     carryover in non-ambulatory individuals with sub-acute stroke.   "
122726|NCT01679587|"     Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat     (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were     to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin,     reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat,     exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional     pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide,     vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine     monophosphate, and noradrenaline   "
122727|NCT01679574|"     The purpose of this study is to compare and determine the efficacy of letrozole     administration to that of combined metformin and Clomiphene in infertile women with     polycystic ovary syndrome (PCOS) not treated before with any ovulation induction agent   "
122728|NCT01679561|"     Both organ-specific and systemic autoimmunity are associated with an increased prevalence of     recurrent miscarriage and reproductive failure, rendering the role of the maternal     immunological system in fertility a key concept. It is believed by some that central to this     theme is the maternal cytokine profile, with particularly T-helper (Th) cells. Immune     modulating therapies have therefore been mooted as potential therapeutic strategies. Recent     reports of high pregnancy rates achievable in women with RIF have added fuel to the debate     regarding the effectiveness of intralipids in modulating the immune system.   "
122729|NCT01679548|"     To compare the efficacy between single-port and three-port laparoscopic assisted vaginal     hysterectomy in patients with benign or preinvasive uterine disease   "
122730|NCT01679535|"     This study will determine if an education program about hygiene and child feeding practices,     taught by local village community health workers, will improve child growth and decrease the     prevalence of childhood malnutrition in a rural region of Kenya.   "
122735|NCT01679470|"     This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy in     the treatment of subjects with primary and/or metastatic tumors of the lung where there is     airway obstruction. In this study patients will be given a systemic IV infusion of particles     and a subsequent escalating dose of laser radiation delivered by optical fiber via     bronchoscopy.   "
122736|NCT01679457|"     The objective of this study is to learn how to improve treatment for clients who are working     hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but     who are not making the progress that would typically be expected. Therefore, the     investigators will be comparing the performance of such clients in a treatment as usual     (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance     and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The     investigators hypothesize that clients will perform significantly better in the ACT-focused     ERP session than they will in the TAU-ERP session. More specifically, the investigators     hypothesize that clients and an independent rater will report that in the ACT-focused ERP     session, clients performed significantly fewer rituals and/or avoidance behaviors, exerted     significantly more effort, had significantly less difficulty getting started with the ERP,     were significantly less influenced by their uncomfortable thoughts/feelings, were     significantly more willing to experience discomfort, were significantly more focused on     working towards what is important to the client. The investigators also hypothesize that an     independent rater will rate clients as significantly more compliant with the ACT-focused ERP     session than with the TAU-ERP session. The investigators also hypothesize that clients will     rate the ACT-focused ERP session as significantly more preferable and acceptable than the     TAU-ERP session, and that they will report being significantly more willing to do the     ACT-focused ERP session again.   "
122737|NCT01679444|"     This protocol will investigate the neurobiological underpinnings of alcohol craving in     recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This     clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and     other brain metabolites correlate to measures of alcohol craving severity   "
122938|NCT01676818|"     This phase II trial studies how well eribulin mesylate works in treating patients with     advanced or recurrent cervical cancer. Drugs used in chemotherapy, such as eribulin mesylate,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing   "
122738|NCT01679431|"     Calcific aortic stenosis (AS) has become the most common cardiac disease after coronary     artery disease and hypertension. Unfortunately no medical therapies have been proven to     decrease either the progression of valve stenosis or the resulting adverse effects on     myocardial remodeling and function. In light of the studies performed in PROGRESSA, it     becomes obvious that: i) AS is a complex and actively regulated process that involves the     interaction of several pathways including lipid infiltration and retention, chronic     inflammation, osteogenic activation, and active mineralization within the valvular tissues;     ii) AS is not a disease strictly limited to the aortic valve but rather a systemic disease     that often involves calcification and stiffening of the aorta and impairment of LV function     as a consequence of pressure overload. Our findings suggest that the dysmetabolic milieu     linked to visceral obesity may accelerate the deterioration of the structure and function not     only of the aortic valve but also of the aorta and of the left ventricle. These findings open     new avenues of research and provide strong impetus for the elaboration of prospective studies     focusing on the valvulo-metabolic risk in AS.      The general hypotheses are: The metabolic abnormalities linked to visceral obesity accelerate     (1) the progression of valvular calcification and stenosis, aortic calcification and     stiffness; (2) the progression of myocardial fibrosis and dysfunction.      The general objectives of the study are to elucidate the mechanisms implicated in the     pathogenesis of AS and to identify the metabolic factors that determine the progression of:     i) aortic valve calcification and stenosis; ii) myocardial fibrosis and dysfunction; and iii)     clinical outcomes.      This study will contribute to identifying the key metabolic determinants of AS progression     and will pave the way for the future development of non surgical therapies for this disease.     The results of this study would provide strong support to the realization of randomized trial     to test the efficacy of lifestyle modification program or new pharmacological treatment     aiming at the reduction of visceral fat and associated metabolic abnormalities in the AS     population. Furthermore, this study will contribute to the identification of novel blood and     imaging biomarkers of faster disease progression, which will help to optimize risk     stratification and timing of AVR in the AS population.   "
122739|NCT01679418|"     Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and     Vomiting (PONV)   "
122740|NCT01679405|"     An open-label, uncontrolled, multicenter phase I/Ib trial to investigate safety and efficacy     of BIBW 2992 added to the standard therapy of Gemcitabine/Cisplatin in chemo-naïve patients     with advanced and/or metastatic adenocarcinoma of the biliary tract   "
122741|NCT01679392|"     In this study we investigate the following properties of the transversus abdominis plane     block in healthy volunteers:        1. Cutaneous analgesic distribution        2. Muscular affection        3. Reproducibility   "
122742|NCT01679379|"     The purpose of this study is to determine the surgical site infection rate and patient     satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean     section in obese women.   "
122743|NCT01679366|"     The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult     patients may shorten the duration, and reduce the severity of the disease.   "
122744|NCT01679353|"     A caudal anesthesia is one of the most commonly used technique providing intra and     postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct     analgesic drugs to local anesthetics for caudal block is common. The most commonly used drugs     are opioids, clonidine, and ketamine. However, their use has been limited by adverse effects     in children.      Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is     the fourth most abundant cation in the body. It has antinociceptive effects in human and     these effects are primarily based on the regulation of calcium influx into the cell.     Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA)     receptor and such NMDA antagonism prevents the central sensitization from nociceptive     stimulation. Many study suggested that epidurally administered magnesium could reduce the     postoperative pain in adults. But few studies are available about the use of magnesium in     pediatrics.      The investigators performed prospective randomized double-blind study to examine the     analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia     on postoperative pain control in pediatric patients undergoing inguinal hernia repair.      80 children (aged 2- 6 yr) undergoing inguinal hernia repair were included in this     prospective, randomized, double-blinded study. After inhalation induction of general     anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal     saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium     50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. Postoperative pain     was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS,     0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be     followed for the duration of hospital stay, an expected average of 3 hours.      After discharge, rescue analgesic consumption, pain scores (Parents Postoperative Pain     Measurement, PPPM), and adverse effects were evaluated for 48h.      The time to first supplemental oral analgesic medication demand was defined as the time from     the end of surgery to the first registration of a PPPM( 0 - 15) ≥ 6 by parent's observation.     48 hours after surgery, reports of delayed side effects and demands for rescue analgesics     from the child were gathered from parents via a telephone interview.   "
122745|NCT01679340|"     To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and     III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less     toxicity.   "
122746|NCT01679327|"     This study evaluates the relationship of biomarker expression and efficacy of bevacizumab     plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the     treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3     expression in tumor tissue by IHC and detect those protein expression level in plasma by     ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D     expression level in plasma by ELISA. The aim of the study is to identify whether those     biomarkers could predict Bevacizumab efficacy.   "
122747|NCT01679314|"     The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease     (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day     over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham     device during these two months while not knowing which device they have been provided. At the     end of the two months, all patients will be asked to continue in the study for another 2     months to self administer with the active AlphaCore device. Subjects will complete diaries at     home on their breathing and quality of life and will return to the clinic monthly for     assessment by the investigator.   "
122748|NCT01679301|"     The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30     participants (to allow for 20 completers) with a prescription for nocturnal oxygen, and     meeting all eligibility criteria. All participants will undergo a single night     polysomnography testing in a sleep lab while they're SpO2 is monitored. The study has a     cross-over design, in which participants will receive their oxygen prescription in two     different modes at different times during the night. The assignment (sleep vs. continuous     mode) to which participants will initiate the night will be randomized, and all participants     will utilize each of the two modes during the study. The hypothesis of this study is that     there will not be a significant difference in oxygen saturation (SpO2) for participants while     they use the SimplyGo Portable Oxygen Concentrator, set in 'Sleep Mode', or pulsed oxygen     flow, as compared to their SpO2 while on continuous flow oxygen during sleep during the     course of the one night sleep study.   "
122749|NCT01679288|"     The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA)     and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general     practitioner in Primary Health Care.   "
122991|NCT01676129|"     The purpose of this study is to measure the effect of nocipoint therapy on patients with     temporomandibular joint disorders (TMD) and compare it with the effect of standard electrical     stimulation therapy.   "
122750|NCT01679275|"     Congenital heart disease with need for early surgery in newborns is associated with an     increased incidence in global impairment in development. The causes of these late adverse     neurologic outcomes are multifactoral and include both fixed (or patient-specific factors)     and modifiable factors. They relate to both the mechanism of central nervous system injury     associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is     a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The     importance of cerebral monitoring in neonates with congenital heart problems at risk of     developing neurological complications is increasingly recognized. In this way the most     vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in     (timing of) treatment.   "
122751|NCT01679262|"     There are several studies that have measured various oropharyngeal airway space distances     using radiological method. However, direct confirmation of optimal size of oropharyneal     airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The     purposes of this study were to directly determinate the proper size of OPA in individual by     FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine     the relationships among the size of OPA, straight length from the incisors to the tip of the     epiglottis by laryngoscopy, patient height, and external facial measurements.   "
122752|NCT01679249|"     An understanding of fluid changes that occur during hemodialysis (HD) with ultrafiltration     (UF) is essential for determining the efficacy of HD, as well as for reducing complications     related to hypovolemia or, conversely, chronic volume overload.   "
122753|NCT01679236|"     A. The study follows a randomized controlled design with approximately 60 smokers with a     history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention     to a matched 7-week education intervention to evaluate intervention effect on smoking     cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness     intervention will yield statistically significantly higher smoking abstinence than controls     as measured by carbon monoxide breath test and Time Line Follow Back at at the end of     treatment (2-weeks post smoking cessation attempt).   "
122754|NCT01679223|"     The purpose of this study is to measure the level of AlloMax™ incorporation (cellular     infiltration, collagen production, and neovascularization) in human breast reconstruction.     The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast     capsule at the 3-4 month time point.   "
122755|NCT01679210|"     The overall goal of this randomized controlled trial is to test the efficacy of a culturally     and linguistically modified, individually-tailored lifestyle intervention to reduce risk     factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a     history of abnormal glucose tolerance during pregnancy.   "
122756|NCT01679197|"     This study involves research about an investigational medicine called metreleptin. The reason     for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or     nonalcoholic fatty liver disease associated with lipodystrophy, a rare disorder associated     with abnormal loss of the body's fat tissue. In this study, metreleptin is considered to be     investigational for the treatment of lipodystrophy. Metreleptin will be given via injections     under the skin. We plan to continue therapy for a period of one year and evaluate the change     in liver disease by a liver biopsy. We will also follow the metabolic parameters (e.g. blood     cholesterol, liver function, insulin resistance) and body composition characteristics (e.g.     the pattern of fat distribution in the body).   "
122773|NCT01678976|"     To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single     900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a     single 900 mg dose of BIA 2-093 and Oxcarbazepine.   "
122829|NCT01678235|"     The aim of this study is to determine whether insulin glulisine is more effective in     postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1     diabetes (T1DM) treated with insulin pump (CSII).   "
122757|NCT01679184|"     Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to     living kidney transplantation and randomize these individuals into a desensitization protocol     in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment     and up to 6 months post transplant.      If desensitization is needed prior to transplantation in individuals with a negative     crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with     routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine     levels) as well as protocol biopsy evaluations.   "
122758|NCT01679171|"     Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome     (e.g. hospital survival) of an ICU stay is improving in this population but little data have     been published on long-term outcome. Beyond survival, outcome assessment in the elderly     requires to evaluate several aspects of health: mental status, activity of daily living,     pain, depression, frailty… referred by geriatrician as comprehensive geriatric assessment'     (CGA).      The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients     mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will     be performed on the patients' site of living.      This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.   "
122759|NCT01679158|"     The purpose of this study is to evaluate the impact of minor variations in Incisionless     Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety,     and weight loss in the treatment of primary obesity. It will confirm, in an open prospective     study, the action mechanisms for the POSE endoscopic treatment technique for obesity, and     it will help determine if they are maintained at least 6 months following the procedure.     Durability of weight loss will be tracked through post-POSE visits up to 18 months following     the procedure.   "
122760|NCT01679145|"     The aim of this project is to assess which behavioral and neuroimaging alterations associated     with reward- based learning predict relapse in alcohol- dependent patients within a follow-     up period of 12 months.      The investigators will explore how these alterations interact with clinical and psychosocial     factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and     positron emission tomography (PET) will be used to identify neurofunctional abnormalities in     neurotransmitter systems. The investigators will also provide data for genetic analysis and     modeling.      Patients will be detoxified in an inpatient setting and followed for 12 months using the     Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and     brain imaging will be carried out within at least 4 half- lives after any psychotropic     medication.      The investigators will implement and apply functional imaging paradigms assessing     Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters     of learning with alcohol craving, intake and prospective relapse risk.   "
122761|NCT01679132|"     The BAROSTIM NEO HTN trial is a prospective, randomized, controlled trial to demonstrate the     safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.      Currently, the BAROSTIM NEO HTN trial is not actively enrolling. CVRx is conducting long-term     follow-up of patients implanted with the BAROSTIM NEO device. This update was not done for     any subject protection concerns that would preclude continuation of the investigation.   "
122762|NCT01679119|"     The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in     combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell     Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based     chemotherapy.      There is no standard of care for the treatment of this group of patients. If demonstrated to     be efficacious and safe to deliver this regimen will be further tested in a phase III trial     to determine whether this should become the standard of care amongst patients with DLBCL not     fit for anthracycline (R-CHOP).   "
122763|NCT01679106|"     Up to 174 patients undergoing renal transplantation will be randomized to one of two groups.     Randomization will be based on computer-generated codes using random block sizes ranging from     4 to 8.      Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA      The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores     will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic     benefit. In addition, the presence of any pain at the incision site will be noted at the 1     month surgical follow-up to determine any evidence of chronic pain.      The investigators hypothesis is that unilateral kidney transplant patients with a continuous     TAP catheter will have decreased pain scores and opioid usage compared to those receiving     standard analgesic therapy.   "
122764|NCT01679093|"     The purpose of our study is to determine if there is an antagonism between drugs used in the     prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen     after thyroidectomy.   "
122765|NCT01679080|"     Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are     fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the     present study is to investigate the effect of treatment of adult OI patients with     bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture     risk and quality of life.      The investigators will therefore conduct a double blind, placebo controlled trial, taking     genotype and previous antiresorptive therapy into account.   "
122766|NCT01679067|"     To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people     are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more     likely to be diagnosed with opportunistic infections, their risk of death is higher and their     rate of immunological improvement is slower (Mussini C et al., 2008). These patients often     present a real challenge due to their advanced clinical status (Borghi V et al., 2008).     Unfortunately, little is known about the clinical presentation of these patients, their     responses to antiretroviral treatment and especially about the changes in the adaptive and     innate immunity of the GALT.   "
122767|NCT01679054|"     This is a retrospective cost-minimization analysis study to compare the costs of treatment     with EOF vs EOX regimens in patients with gastric cancer (GC) in Hong Kong. Patient baseline     characteristics and cost data will be extracted from records and compared.   "
122768|NCT01679041|"     The purpose of this study is to evaluate the toxicity and the effectiveness of high dose     chemotherapy with HPC transplant Multiple Sclerosis that has failed at least two lines of     therapy   "
122774|NCT01678963|"     The purpose of this study is to evaluate the safety and efficacy of topical ophthalmic     squalamine lactate eye drops in treating patients with neovascular age-related macular     degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive,     irreversible, severe loss of central vision.   "
122775|NCT01678950|"     Recently, an uncalibrated minimally invasive Pulse-code Modulator (PCM) has been developed:     the MostCare system. This monitoring system is powered by Pressure Recording Analytical     Method (PRAM), which is based on the mathematical analysis of the arterial pressure profile     changes. It allows beat-to-beat Stroke Volume (SV) assessment from the pressure signal     recorded invasively in radial, brachial, or femoral arteries. The most innovative features of     this method are: 1) the lack of a calibration requirement, 2) the analysis of the arterial     wave signal is performed at 1000 Hz, 3) a dedicated arterial catheter-transducer is     unnecessary. MostCare is powered by PRAM (Pressure Recording Analytical Method) algorithm.     The investigators primary end-point was to evaluate the relationship between Cardiac Output     (CO) measured by MostCare with CO calculated with Echo-Doppler in Intensive Care Unit (ICU)     patients under different clinical conditions. As a secondary end-point the investigators     evaluated the relationship between CO measured by MostCare with CO obtained with     thermodilution techniques (standard bolus thermodilution or transpulmonary thermodilution,     i.e. PiCCO system). This is a prospective multicentre observational study.   "
122776|NCT01678937|"     This study is being done with the purpose of trying to understand if and why transplant     recipients may develop tolerance to their transplanted organ. Tolerance means being able to     lower or take away immunosuppression (anti-rejection medications) without causing organ     rejection.   "
122778|NCT01678911|"     This study is done to investigate the pain relieving effects of the study drug Gralise (a     novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with     Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be     recruited. The purpose of this research is to look at how the study drug can be used to     benefit people who experience this type of pain. This is a phase IV study done to study the     safety and effectiveness of the drug. At this point the drug has been approved by the Food     and Drug Administration and has been reported to be well tolerated and effective in the     treatment of various chronic pain conditions, particularly in neuropathic pain. About 36     subjects will take part in this study.   "
122779|NCT01678898|"     This is the first human treatment with PRX-102, an enzyme being developed as a long-term     enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha     galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be     evaluated in this study of increasing doses. Patients will be treated with infusions every     two weeks for 12 weeks (7 infusions).   "
122780|NCT01678885|"     The primary purpose of this study is to test different methods of measuring energy balance,     including food intake and energy expenditure. Another primary purpose of this study is to see     if energy expenditure predicts weight and change after a weight loss diet. A secondary aim     will be to test the reliability and validity of the Actical accelerometer, SenseWear     Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at     measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against     the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated     energy expenditure or posture allocation from the 3 devices is associated with weight change     during and following a low calorie diet (LCD).   "
122781|NCT01678872|"     The purpose of this study is to examine the long term safety of an experimental gene transfer     agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.   "
122782|NCT01678859|"     Infertility affects approximately one in six couples1. In approximately one third of cases,     there is no cause found as to why a couple are unable to conceive2. In order for natural     pregnancy to occur, sperm must pass through the cervix (neck of the womb) and swim to the     woman's Fallopian tubes so that fertilisation of one of the woman's eggs can occur. It is     known that mid-cycle mucus at the cervix is essential for sperm to gain access to the uterus     and tubes.      There is evidence that the composition of this mucus in women may affect fertility but this     area has not been studied well in recent years, partly because fertility treatments such as     IVF bypass the cervix.      Research in sheep and cows in UCD has shown interesting differences in the cervical mucus of     fertile and infertile animals. It appears that the mucus not only helps sperm to get to the     uterus but may also help the sperm to mature and be ready to fertilise an egg. This mucus may     also help prevent bacteria and infection reaching the womb.      In conjunction with colleagues in UCD, under the leadership of Professor S Carrington, the     investigators would like to investigate some of the properties of human cervical mucus.The     investigators propose to do this by taking samples of cervical mucus around the time of     ovulation and also approximately one week later in fertile women and sub-fertile women. Then     to monitor ovulation with an ultrasound scan (follicle tracking) of the woman's ovaries and     urinary ovulation kits and take blood for oestrogen, progesterone, LH and FSH levels.      The investigators wish to determine if there are differences between the mucus of these women     and how it may impact on sperm function and on fertility.   "
122783|NCT01678846|"     The purpose of this study is to determine whether use of the Good Schools Toolkit is     effective in reducing violence against children in primary schools.   "
122784|NCT01678833|"     Background:      Although some treatments for substance abuse are considered effective for some people who are     drug dependent, many others do not benefit as much over time. Researchers are working to find     out what characteristics predict treatment response. They also want to determine how to     design treatments that are more effective for a greater number of substance abusers. This     pilot study involves providing drug addicts with cognitive behavioral therapy (CBT), a     treatment considered to be one of the most effective in reducing substance-abuse, to identify     ways in which the brain works that may predict and explain treatment effects. A comparison     group will be included that receives only standard psychotherapy or talk therapy. This     approach will enable researchers to determine what factors might be interfering with     favorable treatment outcomes and how to refine or develop new treatments that work well for     more people.      Objectives:      - To identify individual characteristics which predict and explain the effects of CBT in     people with opiate dependence.      Eligibility:        -  Males between 18 and 60 years of age who are dependent on opioids (such as heroin).        -  Participants must be willing to take buprenorphine and receive substance abuse          counseling.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Researchers will ask questions about participants ability to cope in certain situations,          along with questions about drug use and lifestyle issues. These questions will be asked          twice, before and after completing treatment.        -  Participants will be placed into one of two groups. One group will have CBT twice a week          for 8 weeks. The other group will have standard counseling twice per week. Both groups          will take buprenorphine as part of the drug abuse treatment.        -  Participants will have other tests during this study. They will have imaging studies to          look at brain function. These studies will test thinking and decision making.   "
122785|NCT01678820|"     The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin     fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control     while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks     of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated     with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.   "
122786|NCT01678807|"     The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]     and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust     mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least     one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house     dust mite-induced allergic rhinitis/rhinoconjunctivitis.   "
122787|NCT01678794|"     To advance our understanding of the mechanisms of human cardiorenal syndrome with emphasis     upon the interaction of diuretic therapy and the renal-angiotensin-aldosterone -system and     cGMP pathway.      The belief is that the chronic AT1 receptor blockade in subjects with compensated CHF and     renal dysfunction will improve renal function with increased sodium excretion, glomerular     filtration rate and effective renal plasma flow and renal function reserve as compared to the     response of placebo-treated subjects.   "
122788|NCT01678781|"     A study to evaluate, by country and overall, the changes from baseline of the irritable bowel     syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with     Duspatalin® or Dicetel® in IBS patients.   "
122789|NCT01678755|"     This is an efficacy study evaluating a experimental treatment for cognitive deficits in     adults with schizophrenia.   "
122792|NCT01678716|"     This complex evaluation of a large-scale program uses a cluster-randomized design where 20     geographic clusters (subdistricts) were randomized to study two sets of interventions. For     the evaluation of behavior change interventions only, the 20 clusters were randomized to 10     intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a     market-based model for delivering micronutrient powders (MNP) along with behavior change     interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior     Change Communication (BCC)-only area and MNP+BCC areas.   "
122793|NCT01678703|"     This study compares the effectiveness of cervical preparation before second trimester     abortion using laminaria versus vaginal Misoprostol.      The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol     is superior to mechanical preparation using laminaria.      The investigators believe that medical preparation makes the procedure easier to perform,     equally safe, without addition of pain or discomfort.   "
122794|NCT01678690|"     Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort),     to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4)     administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and     safety will also be assessed during this 1-week period.   "
122795|NCT01678677|"     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8     different formulations of investigational NTHI vaccine in current and former smokers, 50-70     years of age.   "
122796|NCT01678664|"     Determine wether 24 months treatment with everolimus prolongs progression free survival rate     (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.        -  H0 a 24 months progression free survival rate less than 35% is unacceptable        -  H1 a 24 months progression free survival rate greater than 35% would show that          everolimus treatment is beneficial, the expected 24 months progression free survival          rate being 50%   "
122797|NCT01678651|"     Different kinetics markers have been proposed to select embryos with higher implantation     rates. The effect of external factors on these markers, such as the stimulation protocol     should be analyzed. There are two different types of FSH that are commonly used for in vitro     fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each     kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if     there is a difference in embryo kinetics and morphology as well as oocyte morphological     parameters between the two types of FSH and therefore to analyze if such markers can be used     despite of the stimulation protocols chosen.   "
122798|NCT01678638|"     The purpose of this study is to determine whether early (before NICU discharge) or late     (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who     have an inguinal hernia.   "
122799|NCT01678625|"     Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care     unit when muscle relaxant drugs have been used in the operating room. The only method of     reliably detecting the presence of neuromuscular blockade is through the use of quantitative     neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and     display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio     of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this     ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the     endotracheal tube can be removed. At the present time, there is only one     commercially-available quantitative monitor available in the United States -the TOF-Watch. It     is not used by many clinicians because it requires experience to obtain accurate results, is     expensive, and is subject to interference by factors in the operating room. The aim of this     investigation is to examine a new quantitative monitor (the T4-EMG (EMG = electromyography)     that may not be subject to the same limitations as the TOF-Watch AMG (AMG =     acceleromyography). In order to study the accuracy of this new device, the T4-EMG will be     compared to the current clinical gold standard, the TOF-Watch.   "
122800|NCT01678612|"     Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality.     Commonly touched items in the patient care environment harbor microorganisms that may     contribute to HAI risk. The purpose of this study is to assess whether placement of     copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in     comparison with non-copper surfaced objects.   "
122801|NCT01678599|"     The purpose of this study is to estimate the gain in sensitivity of several multiple-sample     strategies of PCR samples with respect to the current standard (single sample of 10 ml) to     detect Chagas chronic stage at baseline and to identify the optimal sampling strategy based     on the sensitivity, cost,the completeness of sampling and the acceptability for study     patients.   "
122802|NCT01678586|"     In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized     clinical trial to compare the clinical effectiveness of radicular pain relief by either     acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative     Sensory Testing (QST).   "
122803|NCT01678573|"     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations     change over time) of abiraterone acetate after oral administration of abiraterone acetate at     different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under     fasted conditions.   "
122804|NCT01678560|"     Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to     the patient in terms of serious co-morbidities and results in a great cost to the VA Health     Care System to treat the co-morbidities, which include heart disease, stroke and     neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and     studies have shown a poor adherence to treatment. The investigators hypothesize that using     wireless technology will lead to early detection of problems of treatment use and will     translate into early remedial action which will improve the use and effectiveness of     treatment. The investigators will compare two methods. Usual care involves downloading data     from PAP machines at designated 3-month intervals, requiring a face-to-face clinician visit.     Wireless care involved more frequent monitoring and intervention in the event of anomalies in     treatment use or effectiveness.   "
122853|NCT01677923|"     The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and     increases insulin sensitivity; the study team hope to get better effect of weight decrease     and metabolic processes repair in the intensive treatment group with intervention of physical     activity, diet correction and Metformin use.   "
122805|NCT01678547|"     Stroke are the main causes of motor disability among adults and are expected to impose an     increasing social and economic burden for our Country. The impact of stroke on patients is     enormous, with negative ramifications on the persons participation in social, vocational, and     recreational activities. It is the primary cause of long-term disability in these countries.     At the present stage, it is well known that control of balance during upright standing     depends upon the central integration of afferent information from vestibular, somatosensory     (proprioceptive, tactile), and visual systems, which constitute a multilink neural network     for the control of neck, hip, and ankle joints. More recently, it has been studied at the     level of cerebral cortex; vestibular inputs would reach face/neck representation of primary     somatosensory cortex and would be then integrated with visual and somatosensory inputs in     intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably,     balance impairment and the associated risk of falling represent one of the most prominent and     potentially disabling features in stroke subjects. The specific aims of this project are: to     verify whether the robotics lower limb treatment with body weight support is more effective     than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to     improve the quality of the gait and the endurance and to analyze possible improvements in     terms of physiological biomechanical gait through analysis of spatio-temporal parameters.   "
122806|NCT01678534|"     Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind,     placebo-controlled, with sequential inclusion of patients   "
122807|NCT01678521|"     Inflammation plays a major role in atherosclerosis. Pentraxin 3 (PTX3) a multifunctional     pattern-recognition protein, is expressed in many tissues/cells, including innate immunity     cells, endothelium and atherosclerotic plaques. Its role is controversial: it may exert     protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and     future cardiovascular risk.      LDL-Apheresis removes apoB100-containing lipoproteins and it can prevent progression of     coronary artery disease (CAD). LDL-Apheresis exerts non-lipidic beneficial effects on the     procoagulatory state and on hemorheology. No data exist about the effects of LDL-Apheresis on     plasma PTX3 levels.   "
122808|NCT01678508|"     In a population-based study to explore the impact of TPMT-status on the risk of relapse and     of second cancer among all patients treated according to the NOPHO ALL2000.   "
122809|NCT01678495|"     It has proposed the use of ST without microbubble treatment in randomized association with     both intravenous and intra-arterial thrombolysis, but combined treatment (rtPA + U.S.)     associated with MB diagnostic not yet been investigated in a randomized study.      The aim of this study is to evaluate efficacy of the combined treatment (r-rtPA+US+MB) vs the     standard rtPA treatment in a randomized study in consecutive patients with acute ischemic     stroke.      We expect to demonstrate that the combined treatment (rtPA+US+MB) will be statistically     superior to standard treatment in terms of recanalization rate.   "
122810|NCT01678482|"     This is a clinical research study to determine the ability of the Clear device to treat mild     to moderate inflammatory acne, and to determine if the average person is able to use the     device properly according to the labeling as describe in the operator manual.      The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in     which the subjects will be treating themselves with the Clear device, and 2 follow-up visits     to evaluate the results. The clinical result will be assessed by the investigator for     improvement in the acne condition. Treatment will be performed on the face of subjects     enrolled and who meet the inclusion criteria.   "
122811|NCT01678469|"     Background Gestational diabetes mellitus (GDM) is defined as a defect of glucose tolerance     with its onset or its first recognition during pregnancy and that usually disappears, at     least temporarily, after delivery. Its prevalence generally ranges between 3 and 6%, but may     reach 12 to 15% in high-risk populations or specific ethnic groups. GDM increases the risk of     potentially severe maternal, fetal and neonatal complications (gestational hypertension,     pre-eclampsia, caesarean delivery; macrosomia; shoulder dystocia). These risks are linearly     correlated with the level of maternal hyperglycaemia. GDM is due to a failure of pancreatic     beta cells to sustain compensatory insulin secretion for insulin resistance that is     physiological in pregnancy but can be much more pronounced in some women, especially in case     of overweight or obesity. Maternal obesity is a major risk factor of GDM. Yet, micronutrient     deficiencies are frequently reported in obese patients. Some nutritional deficiencies,     concerning particularly some lipophilic micronutrients (vitamin A, vitamin D, vitamin E,     carotenoids) may be associated with diseases linked to insulin resistance. Numerous studies     show an inverse relationship between plasma concentrations and/or dietary intake of these     micronutrients and incidence of type 2 diabetes. Vitamin D deficiency could be involved in     the pathogenesis of type 2 diabetes through an alteration of insulin secretion and     sensitivity. Deficiencies in vitamin A, vitamin E or carotenoids (in particular lycopene and     beta carotene) increase oxidative stress and pro-inflammatory status, and could thus be     implied in the physiopathology of insulin resistance and glucose intolerance.      Some case-control studies find an inverse correlation between the plasma concentrations of     vitamin D during pregnancy and the incidence of GDM, independently of age, ethnic origin and     of body mass index. Data are scarce for vitamin A and vitamin E, and are lacking for     carotenoids. Besides, the few available studies are mainly descriptive ones, without clear     explanations on underlying mechanisms. The favourable effects of these micronutrients on     insulin sensitivity could be partially mediated by adipokines and/or pro-inflammatory     cytokines secreted at the level of the adipose tissue. Numerous studies showed that women     developing GDM during their pregnancy presented with a significant decrease in the     circulating rates of adiponectin, (that is an adipokine with anti-inflammatory and     insulin-sensitizing properties) and a significant increase in the secretion of the     pro-inflammatory cytokines implied in the physiopathology of insulin resistance. In our     laboratory (INRA unit 1260), we showed in experimental works conducted in vitro in human     adipocytes and in vivo in mice that vitamin E could induce the transcription and the     secretion of adiponectin; we also showed that vitamin D or lycopene could modulate the     inflammatory reaction in the adipose tissue, which is involved in the physiopathology of     insulin resistance.      Aims and methods We hypothesise that, in pregnant women, there is a link between plasma     concentrations and dietary intakes of lipophilic micronutrients (mainly vitamins A, D, E and     carotenoids), secretion of adipokines and pro-inflammatory cytokines, and risk of developing     a GDM; we also hypothesise that this relationship is independent of age, body mass index,     ethnic origin and other main risk factors of GDM. To test this hypothesis, we aim to lead a     transversal monocentric study, within a population of 500 pregnant women submitted to a     systematic screening of GDM by an oral glucose tolerance test (OGTT) in the Hôpital Nord of     Marseilles.      The main criterion of evaluation of the link between lipophilic micronutrients and GDM will     be a nutritional score calculated as follows: for each micronutrient (vitamin A, D, E,     lycopene, beta carotene, alpha carotene, lutein), we will attribute 0 point if the patient is     situated in the lowest quartile, 1 or 2 points in the following quartiles, and 3 points in     the highest quartile. At the end, each patient will thus have a score between 0 and 21     reflecting the global status of these micronutrients.      The main secondary objectives will be to define the relationships between the plasma     concentrations and dietary intakes of these micronutrients and 1/the value of glycemia and     insulinemia during OGTT 2/the degree of insulin sensitivity estimated by the measure of HOMA     index, 3/the circulating rates of some adipokines (mainly adiponectin, leptin, chemerin) and     pro-inflammatory cytokines (TNF alpha, IL-1, IL-6), and 4/the children's birth weight.   "
122812|NCT01678456|"     Prospective registration and independent assessment of SAE associated with atrial     fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by     a Critical Event Committee.   "
122813|NCT01678443|"     This phase I trial studies the side effects and best dose of monoclonal antibody therapy     before stem cell transplant in treating patients with relapsed or refractory lymphoid     malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal     antibody BC8, can find cancer cells and carry cancer-killing substances to them without     harming normal cells. When the healthy stem cells from a donor are infused into the patient     they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,     and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be     an effective treatment for relapsed or refractory lymphoid malignancies.   "
122814|NCT01678430|"     The purpose of this study is to compare ofatumumab & chlorambucil (O-Chl) versus ofatumumab &     bendamustine (O-B) in patients with Chronic Lymphocytic Leukaemia who are considered not fit     enough for rituximab, fludarabine & cyclophosphamide (R-FC).   "
122815|NCT01678417|"     Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of     less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has     relatively good prognosis, continual treatment is needed due to frequent relapse. FL with     histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma.     Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of     relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using     131I-rituximab in refractory or relapsed patients with FL or MCL   "
122816|NCT01678404|"     Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with     variable differentiation status, which is distributed to a variety of organs.      A high response rate and long term survival is possible through surgery or radiation therapy     alone in the case of limited disease. However frequent relapse and progression is observed     despite of long term survival. The treatment after relapse has not been established yet.      So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or     relapsed patients with MZL.   "
122817|NCT01678391|"     To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone     removal without use of fluoroscopy. Success for this study will be defined as the successful     removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will     only be used at the end of a presumed successful procedure to confirm that all stones are     removed.   "
122854|NCT01677910|"     The primary objective of the study is to confirm that at least 1 or more doses of telotristat     etiprate compared to placebo is effective in reducing the number of daily bowel movements     (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the     trial in patients not adequately controlled by current SSA therapy.   "
122818|NCT01678378|"     This community-partnered participatory study will work within high school health centers     (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention     to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this     study is to examine the effectiveness of the School Health Center Healthy Adolescent     Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic     environment, and the schools in which the SHCs are located. Evaluation of the intervention     will involve random assignment of eight comparable SHCs in the Greater Bay Area of California     that provide comprehensive health services, to either intervention or control sites.     Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be     assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks     follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm     reduction and ARA-related resources as well as intentions to intervene with peers. For youth     reporting recent ARA victimization, the investigators will assess for increases in ARA     disclosure, resource utilization, as well as reduction in ARA victimization.   "
122819|NCT01678365|"     A prospective open randomized study conducted between July 1st 2008 and June 30th, 2009.     Included were children younger than 14 years with Complicated appendicitis randomly assigned     either to a single daily dose of Ceftriaxone and Metronidazole or Ampicillin, Gentamicin, and     Metronidazole. The outcome variables compared were: maximum daily temperatures, overall     duration of fever, time return to oral intake, length of antibiotic therapy, results of     repeat WBC measure, general/intra abdominal complications, need for intra abdominal abscess     drainage, Length of stay and adverse reaction.   "
122820|NCT01678352|"     This is a pilot study of a vaccination regime that is designed to efficiently induce     anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with     BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will     induce potent anti-glioma immune response with minimal or no toxicity.   "
122821|NCT01678339|"     Thi is an observational, non interventional, cohort analysis by using administrative     databases (drugs treatment, laboratory and diagnostic tests, specialist visits and     hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute     Coronary Syndrome (ACS) event.   "
122822|NCT01678326|"     The purpose of this study is to prospectively compare the efficacy of endoscopic     ultrasound-guided biliary interventions (EUS-rendezvous or direct EUS-guided therapy) to that     of advanced ERCP cannulation techniques in the setting of difficult cannulation. We     hypothesize that EUS-guided interventions will be more successful and may be associated with     the same complications as using advanced ERCP techniques in cases of difficult bile duct     access.   "
122823|NCT01678313|"     To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the     potential predictive value of the absence of prostate cancer in the treatment of patients     with LUTS/BPH and an elevated serum PSA level.      Patients who meet all eligible requirements for entry into the study will be randomized into     one of the two treatment groups for 3 months in 2:1 ratio as shown below:        1. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)        2. Doxazosin 4mg every day (QD)   "
122824|NCT01678300|"     The purpose of this protocol is:        1. To quantify the prevalence of adherence to topical mesalamine in patients with UC        2. To describe the determinants of medication adherence in patients with UC prescribed          topical mesalamine   "
122825|NCT01678287|"     This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after     repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy     adult male and female subjects.   "
122826|NCT01678274|"     Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes     affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence     of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and     autoimmune diseases in general.      Our study aim is:        -  Using MRI to further characterize and find risk factors leading to aortic dilation.        -  Using MRI to assess the degree of aortic distensibility.        -  Using Computed tomography x-ray scanning of the heart and coronary arteries to          characterize the prevalence and degree of ischemic heart disease and coronary anomalies.        -  Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of          aortic stiffness when compared to controls using end points as Pulse Wave Velocity,          Augmentation Index and Central Pulse Pressure.   "
122827|NCT01678261|"     The human genetic material consists of 46 chromosomes of which two are sex chromosomes. The     sex-chromosome from the mother is the X and from the father the Y-chromosome. Hence a male     consist of one Y and one X chromosome and a female of 2 X-chromosomes. Alterations in the     number of sex-chromosomes and in particular the X-chromosome is fundamental to the     development of numerous syndromes such as Turner syndrome (45,X), Klinefelter syndrome     (47,XXY), triple X syndrome (47,XXX) and double Y syndrome (47,XYY). Despite the obvious     association between the X-chromosome and disease only one gene has been shown to be of     significance, namely the short stature homeobox gene (SHOX). Turner syndrome is the most well     characterized and the typical diseases affecting the syndrome are:        -  An Increased risk of diseases where one's own immune system reacts against one's own          body (autoimmune diseases) and where the cause of this is not known; For example          diabetes and hypothyroidism.        -  Increased risk of abortion and death in uteri        -  Underdeveloped ovaries with the inability to produce sex hormones and being infertile.        -  Congenital malformations of the major arteries and the heart of unknown origin.        -  Alterations in the development of the brain, especially with respect to the social and          cognitive dimensions.        -  Increased incidence obesity, hypertension, diabetes and osteoporosis.      In healthy women with to normal X-chromosomes, the one of the X-chromosomes is switched off     (silenced). The X-chromosome which is silenced varies from cell to cell. The silencing is     controlled by a part of the X-chromosome designated XIC (X-inactivation center). The     inactivation/silencing of the X-chromosome is initiated by a gene named Xist-gene (the X     inactivation specific transcript).This gene encodes specific structures so called lincRNAs     (long intervening specific transcripts) which are very similar to our genetic material (DNA)     but which is not coding for proteins. The final result is that women are X-chromosome mosaics     with one X-chromosome from the mother and the other X from the father. However, numerous     genes on the X-chromosome escape this silencing process by an unknown mechanism.     Approximately two third of the genes are silenced, 15 % avoid silencing and 20 percent are     silenced or escape depending on the tissue of origin.      The aforementioned long non-protein-coding parts of our genetic material (LincRNAs) are     abundant and produced in large quantities but their wole as respect to health and disease     need further clarification. Studies indicate that these LincRNAs interact with the protein     coding part of our genetic material modifying which genes are translated into proteins and     which are not. During this re-modelling there is left foot prints on the genetic material     which can indicate if it is a modification that results in silencing or translation of the     gene. It is possible to map these foot prints along the entire X-chromosome using molecular     techniques like ChIP (Chromatin immunoprecipitation) and ChIP-seq (deep sequencing).      The understanding achieved so far as to the interplay between our genetic material and     disease has arisen from genetic syndromes which as the X-chromosome syndromes are relatively     frequent and show clear manifestations of disease giving the researcher a possibility to     identify genetic material linked to the disease. Turner and Klinefelter syndrome are, as the     remaining sex chromosome syndromes, excellent human disease models and can as such help to     elaborate on processes contributing to the development of diseases like diabetes,     hypothyroidism, main artery dilation and ischemic heart disease.      The purpose of the study is to:        1. Define the changes in the non-coding part of the X-chromosome.        2. Identify the transcriptome (non-coding part of the X-chromosome)as respect to the RNA          generated from the X-chromosome.        3. Identify changes in the coding and non-coding parts of the X-chromosome which are          specific in relation to Turner syndrome and which can explain the diseases seen in          Turner syndrome.        4. Study tissue affected by disease in order to look for changes in the X-chromosome with          respect to both the coding and non-coding part of the chromosome.      6. Determine if certain genes escape X-chromosome silencing and to establish if this is     associated with the parent of origin.   "
122828|NCT01678248|"     to determine the effectivness of intravitreal avastin injection on visual acuity on people     that suffer from central retinal vein occlusion   "
122830|NCT01678222|"     Background:      - The immune system contains several different types of cells in the blood and other parts of     the body. The body can fight infections well with the right balance of these cell types. The     wrong balance of cell types may cause diseases, such as allergies or asthma. The COX-2 gene     may help decide the balance of cell types that the body makes as part of the immune system.     It may also play a role in certain immune system diseases. Researchers want to see how COX-2     affects the cells in the immune system.      Objectives:      - To study how the COX-2 gene works in the body s immune system.      Eligibility:      - Individuals 18 years of age and above who are part of the Environmental Polymorphisms     Registry.      Design:        -  Participants will have one study visit at the National Institutes of Health. They will          collect a urine sample at home on the morning of the study visit.        -  Participants will have a physical exam and medical history. They will provide a blood          sample. They will also give researchers the urine sample they collected that morning.        -  No treatment will be provided as part of this study.   "
122850|NCT01677962|"     The main purpose of this study is to examine the safety of the study drug in patients with     locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know     about any side effects a patient may have when given the study drug. Another goal of the     study is to determine if combining dendritic cells and the study drug can be possibly used as     a vaccine for this disease. Dendritic cells are cells that are present in the body's immune     system that help your body fight disease.   "
122831|NCT01678209|"     The growing number of medications used to treat attention-deficit/hyperactivity disorder     (ADHD) raises important questions about whether different medications have similar or     different therapeutic mechanisms of action. We have recently shown that the stimulant     methylphenidate (MPH) and the non-stimulant atomoxetine (ATX) produce clinical improvement     via a common mechanism in motor cortex, and distinct actions in frontostriatal and midline     cingulate-precuneus regions. These exciting findings offer a window into the common and     unique neurophysiological mechanisms of response to stimulant and non-stimulant treatments.     However, the interpretation and clinical utility of these results would be greatly enhanced     by in-depth investigation of the impact of the two treatments on relevant neural networks,     and analyses which evaluate whether improvement is achieved via normalization or other     adaptive changes in brain function.   "
122832|NCT01678196|"     This project begins to evaluate the effectiveness of a web-based family outreach tool that is     designed to promote treatment engagement among Veterans with posttraumatic stress disorder     (PTSD) or alcohol use disorders (AUDs) but who have not yet engaged in mental health care.     The National Center for PTSD has developed an on-line, Veteran-tailored, interactive web tool     called VA - Community Reinforcement and Family Training (VA-CRAFT) that trains family members     to effectively help their Veterans to engage in treatment for PTSD and/or AUDs. This project     will provide preliminary information about VA-CRAFT's effectiveness.   "
122833|NCT01678183|"     This study is a pilot study. The investigators have designed a randomized, controlled trial     of financial incentives in medication adherence, focusing primarily on poorly-controlled     diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that     many patients do not take their medications as prescribed by their doctors. This contributes     to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and     death. The investigators hypothesize that use of a financial incentive will motivate patients     to improve their medication adherence and ultimately their control of their chronic diseases.      The investigators plan to identify patients who get Primary Care at Boston Medical Center who     still have high blood sugars more than a year after their diabetes diagnosis, and randomize     them to a control arm, or one of two intervention arms. Subjects will be approached at the     time of a regularly-scheduled appointment with their Primary Care doctor and offered the     opportunity to participate in the study. All subjects who agree to participate in the study     will meet with a Clinical Pharmacologist to review their medications in detail, and then     undergo randomization. Subjects in the first intervention group will receive a cash incentive     for picking up medications for the targeted conditions from the pharmacy each month. Subjects     in the second intervention group will receive a cash incentive for picking up medications for     the targeted conditions from the pharmacy each month, and a one-time payment at the     conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators     will enroll a total of 100 subjects in the study, and anticipate an observational cohort of     approximately 1,000 patients.      All patients who are eligible for the study but who are not enrolled in the study and have     not declined to participate in the study will become the observational cohort for the study.     The observational cohort will be used to determine whether randomization to the control arm     of the study has a negative, rather than neutral, effect on patients.      At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to     have their blood pressure checked and to have their blood drawn so that their blood sugar and     cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel,     systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and     macrovascular complications, and death.   "
122834|NCT01678170|"     This trial is going to evaluate the value of blood-oxygen functional imaging technology in     the diagnosis of breast diseases.   "
122835|NCT01678157|"     The objective of this study is to examine the safety and efficacy of porcine acellular dermal     matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of     laparoscopic large paraesophageal hernia repair.   "
122836|NCT01678144|"     The purpose of the trial is to demonstrate the safety, performance and implantability of the     Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial     aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty     rings.   "
122837|NCT01678131|"     This study will evaluate the technical feasibility of using fine needle aspiration (FNA) of     liver tissue to obtain vaniprevir (MK-7009) liver pharmacokinetic (PK) data, working towards     identifying a minimally invasive, reproducible platform to measure liver PK. The study will     be done in 2 parts. In Part 1, participants will be randomized to one of five FNA/core needle     biopsy (CNB) time-point collection sequences. In Part 2, participants will be randomized to     one of two possible doses of vaniprevir and will be assigned to one of five FNA/CNB     time-point collection sequences; participants in Part 2 will also receive background therapy     with pegylated interferon alpha-2b (Peg-IFN alpha-2b) and ribavirin (RBV). The primary     hypothesis is that there is a greater than 80% posterior probability that vaniprevir     concentrations are successfully obtained at least 60% of the time from FNA liver samples     collected at 2 of 3 specified timepoints.   "
122838|NCT01678118|"     Patient navigators have been shown to assist people seeking cancer screening and other     medical services. The purpose of this study is to see whether a patient navigator can link     smokers to available community resources shown to help smokers quit smoking.   "
122839|NCT01678105|"     This is a non-randomized, phase II, open label study of dovitinib in patients with     progressive, recurrent and/or metastatic adenoid cystic carcinoma (ACC). The primary purpose     of this study is to assess the anti-cancer effects of dovitinib in this population in order     to evaluate whether dovitinib is worthy of further study in patients with progressive ACC.   "
122841|NCT01678079|"     This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka,     Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg,     1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one     with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and     the other with a micronutrient supplement powder containing encapsulated calcium at the same     dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium     absorption will be measured using the dual stable isotope method. For each test, the     formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable     isotope will be given orally and a 42Ca-labeled stable isotope dose will be given     intravenously. Urine will be collected for 48 hours to measure calcium absorption.   "
122851|NCT01677949|"     Study Design:      This is a two-stage Phase II trial investigating the efficacy of Clofarabine,     Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual     disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the     study treatment in eliminating the presence of minimal residual disease without causing a     significant delay of allo-HCT due to treatment related toxicity. The intent of this study is     to allow patients to proceed to transplant (independent of this study) within 42 days of Day     1 of Clofarabine based therapy.   "
122842|NCT01678066|"     Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate     information when placed on a patient's Right or Left side.      Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac     output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The     FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the     manufacturer in pediatric and adult patients with leads placed on the left side. However,     sometimes the surgical site and/or patient position precludes placement of the monitor leads     on the left side. In such situations it would be useful to know whether placement of the     monitor's leads on a patient's right side gives accurate cardiac output data. We will     prospectively collect, and compare, simultaneous physiologic data for all enrolled children     using two monitors, one on the patient's right side and one on the patient's left side.   "
122843|NCT01678053|"     Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise in     the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing,     hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are     recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection     into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but     causes significant voice loss, occasional difficulty swallowing and, in our clinical     experience, is associated with significant recurrence. The investigators propose injecting     another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to     maintain the benefit of injection with less loss of voice. The investigators have shown the     effectiveness of this treatment in a small, retrospective analysis.   "
122844|NCT01678040|"     One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right     ventricular (RV) volumes. There are a number of congenital heart defects and acquired     conditions in which management decisions are fundamentally based on ventricular volumes. The     gold standard for assessment of RV volume is CMR. It has better near-field resolution than     echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable     to the irregular geometry of the RV. The objectives of this study are (1) to assess     ventricular volumes in the fasting state and after oral hydration in order to assess the     effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect     of hydration on ventricular volumes compared the effect of with inter-observer and     intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber     deformation, including strain and peak strain rate. This study hypothesizes that (1)     hydration status has an effect on right and left heart volumes, measured by CMR in healthy     volunteers; (2) the effect of volume status will be a more significant contributor to     variability in RV volumetry than that of inter-observer variability and intra-observer     variability, and; (3) atrial and Ventricular deformation corrected for chamber size or volume     is more accurate than when uncorrected for volume.   "
122845|NCT01678027|"     Helicobacter pylori infection is associated with gastric cancer in epidemiological studies.     However, it is still unknown whether H. pylori eradication is useful and required to prevent     gastric cancer.      Gastric cancer risk is increased in family members of gastric cancer patient. Though there is     no direct evidence that H. pylori infection is a risk factor for gastric cancer in family     members of gastric cancer, current European guideline recommends H. pylori eradication in     first-degree relatives of gastric cancer patients.      In this study, the investigators will evaluate whether H. pylori eradication can reduce     gastric cancer risk in the first-degree family members of gastric cancer patients.   "
122846|NCT01678014|"     Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and     young adult women. There are many methods in the treatment of AN, such as family therapy,     cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are     refractory to all current medical treatment and never fully recover and the standardized     mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia,     stereotactic functional neurosurgery may be the better choice. Deep brain stimulation and     capsulotomy are the most used methods which has been proved effective in obsessive and     compulsive disorders, depression and other psychiatric disorders. Many case reports indicate     that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there     are some common pathways between AN and other psychiatric disorder. The investigators have a     hypothesis that deep brain stimulation and capsulotomy may be promising methods in the     treatment of AN.   "
122885|NCT01677507|"     Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to     medications is a critical barrier for the clinician to consistently provide highly effective     IOP-based treatments. Current trial-and error approaches to glaucoma management are     inefficient and have not addressed this barrier as there are no predictive factors for drug     response. Our long-term goal is to improve outcomes by identifying biomarkers and     environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of     disease progression, poor response to treatment, and large IOP fluctuation. Our purpose of     this research project is to address this critical barrier by focusing on physiological     factors that predict IOP response to drugs.   "
122847|NCT01678001|"     The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of     the foot.      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical     treatment modalities. Surgical treatment of plantar fasciitis is indicated only if     nonsurgical means fail.      A newer method of treating plantar fasciitis before resorting to surgery is the use of     Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis     with Xeomin is important, as there are limited studies on the subject to date. The purpose of     this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in     one physician's (J.A.) practice at Rothman Institute Orthopaedics through a     placebo-controlled, randomized, double-blinded study.   "
122848|NCT01677988|"     This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research     study is to determine the safety and effectiveness of modified Folfirinox and radiation     therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening     tests will be done to determine if subjects are eligible for participation in this study. If     subjects are eligible to participate and agree to participate they will begin chemotherapy.     After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of     completing radiation therapy, subjects will have surgery. There will also be post-treatment     and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after     their initial registration.   "
122849|NCT01677975|"     The goal with this study is to evaluate the value of dynamic lymphscintigraphy and     ultrasoundscanning preoperative in patients with melanomas.   "
122852|NCT01677936|"     The objective of this study is to compare the effects of Raisins three times per day versus     alternative snacks three times per day on blood sugar control and cardiovascular risk factors     (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2     Diabetes Mellitus. These effects will be studied over a 12 week period.   "
122857|NCT01677871|"     During the Study:        -  Subject is required to visit every week for the first 2 months and then every month till          completion of study or as and when required        -  The usual symptomatic and supportive treatment of Chronic Liver Disease, including use          of antiviral, will be given to all patients.        -  Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular          Treatment.        -  Liver function tests (LFT) will be done weekly during first 2 months then at one month          interval or as when required.        -  The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of          clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9.          Patients not improving at 4 weeks after initiation of treatment will be shifted to          alternative regimens and will be excluded from the study.   "
122858|NCT01677858|"     The study had the following primary objectives:        -  Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib          and dexamethasone for patients with relapsed or refractory multiple myeloma who have          received 1 to 3 prior therapies        -  Phase 2: to estimate the overall response rate (ORR) for patients with relapsed or          refractory multiple myeloma who received 1 to 3 prior therapies treated with carfilzomib          and dexamethasone QW at the MTD established in phase 1.   "
122859|NCT01677845|"     The aim of this study is to determine the maximum tolerated dose of hypo-fractionated     radiation therapy and the toxicity of the treatment program.      Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this     phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT).     Dose escalation will be as follows:      There will be 3 cohorts consisting of 3 patients each.   "
122860|NCT01677832|"     Children and adolescents with ADHD are impulsive and have difficulties in regulating their     behaviors. It has been suggested that a core deficit in inhibitory control may account for     dysfunctional behaviors associated with this disorder. Previous research has shown that     medication and the self-regulation strategy of making implementation intentions (i.e.,     if-then plans) are effective in enhancing children's inhibitory control, which is reflected     in the behavioral as well as electrophysiological (e.g., Electroencephalogram; EEG) data on a     Go/NoGo task in children with ADHD. As suggested by earlier research, however, forming     implementation intentions may have different effects on people who are embedded in different     cultures.      The aim of the present study is to compare the effects of medication and the self-regulation     of forming implementation intentions by assessing the behavioral performance and     corresponding brain activity during a Go/NoGo task in children and adolescents with and     without ADHD under two different cultural contexts. Further, this study also aims at     investigating the potential moderating effects of culture on making if-then plans. More     important, as we know, this will be the first study to compare the effectiveness of forming     implementation intentions on children and adolescents with ADHD in a cross-cultural way,     which is meaningful for researchers to explore the degree of its application and expected to     provide clinical psychologists an alternative perspective for ADHD treatment in the near     future.   "
122861|NCT01677819|"     The objectives of this study are to investigate:        1. the effect of methylphenidate on attention;        2. the relations between methylphenidate and inhibition control and working memory;        3. the relations between inhibition control and verbal attention and working memory;        4. the effect of methylphenidate on the changes of neuropsychological functioning and blood          pressure.   "
122862|NCT01677806|"     Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom     medical management has not been successful or for those who are at risk for developing     complications due to long-term immobilization. Recently, three randomized controlled trials     (RCT) concerning PVP have been published with conflicting results. Two RCTs with a sham     control intervention failed to show an advantage of vertebroplasty over placebo for     participants with acute, subacute, and chronic fractures or severe pain. In the third RCT,     PVP compared to optimal conservative treatment showed significant immediate postoperative     pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these issues,     this study is initiated to compare PVP with conservative therapy in patients with     osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP     increases the incidence of new compression fractures in adjacent vertebrae.   "
122886|NCT01677494|"     Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement     imaging), biology (markers of collagen turn-over) and proteomics   "
122863|NCT01677793|"     Magnetic resonance imaging (MRI) is a premier modality to investigate structures and     functions of human brain. In studies of children and adolescents, noninvasiveness of MRI     makes it especially applicable. Developmental trajectory of gray matter volume and cortical     thickness has been well studied in western countries. However, significant variability of     brain structure has been reported between Chinese and Caucasian, and the variation may also     exist in developmental trajectory of the brain. However, the maturation processes of neural     fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has     been frequently used to investigate the integrity of fibertracts in the literature, is     limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly     developed technique to improve the resolution of crossing fibers, and it is more suitable for     detailed tractography assessment. In addition to establishing the template of brain structure     (T1 and T2) and structural connectivity of our child, adolescent, and young adult population,     the study has the following three aims.        1. To describe gender effect and developmental change of brain volume of different cortical          and subcortical regions, thickness of cortex brain, and structural connectivity (e.g.,          frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and          superior longitudinal fasciculus II) across childhood through adolescent to adulthood;        2. To examine the gender effects and developmental change of attention, executive function          and visual memory from childhood to adulthood and whether gender moderates these          developmental changes; and        3. To correlate the structural connectivity and brain size and neuropsychological function          within the same subjects.   "
122992|NCT01676116|"     This trial is conducted in Europe, Oceania and the United States of America (USA).      The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in     controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like     peptide-1 (GLP-1) receptor agonist and OAD therapy.   "
126112|NCT01634360|"     A 48-month open label multi-centered extension study to evaluate the long-term safety,     tolerability and efficacy of E2007 in patients with Parkinson's Disease with wearing off     motor fluctuations and on period Dyskinesias.   "
122864|NCT01677780|"     This open-label, extension study is designed to provide continuing treatment with RO5045337     to participants who have completed parent studies NO21279 (NCT00623870), NO21280     (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).     Participants are eligible to participate in this study if they have completed required Phase     1 study assessments for primary objectives of respective parent protocol and are having     evidence of clinical benefit (as defined by the parent protocol). Participants will continue     the most similar dose and formulation available (which does not exceed the maximum tolerated     dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and     the same schedule of RO5045337 treatment that they were receiving at the time of     transitioning from the parent clinical study protocol.   "
122865|NCT01677767|"     This observational study will evaluate the use in clinical practice and efficacy of Mircera     (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis     receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be     followed for 24 weeks.   "
122866|NCT01677754|"     This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled     study will evaluate the efficacy and safety of RO4602522 in participants with moderate     severity Alzheimer's disease. Participants who are taking background therapy of     acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4     months before screening will be randomized to receive either one of two doses of RO4602522 or     placebo for 12 months.   "
122868|NCT01677728|"     The aim of this study is to explore whether target therapy in combination with chemotherapy     as treatment could improve survival or tumor response in patients undergoing Synchronic     Hepatectomy for Colorectal Liver Metastases.   "
122869|NCT01677715|"     Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on     Immunity and Physical Intestinal Canal   "
122870|NCT01677702|"     The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective     in reducing the occurrence of flu symptoms.   "
122871|NCT01677689|"     Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue     cyanobacterium with patented freeze-thaw lysis and extraction method. According to the     preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral     ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause     illness, paralysis and even death, especially in children and elderly people. This phase II     study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in     subjects with seasonal influenza.   "
122872|NCT01677676|"     This study has been designed to evaluate the safety and immunogenicity of two different     formulations of FP-01.1 as well as build on the data set from the first in human study     FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best     formulation of the vaccine to evaluate in efficacy studies.   "
122873|NCT01677663|"     Autism or autism spectrum disorder (ASD) is a relatively common (0.3% in Taiwan),     multi-factorial, genetically and clinically heterogeneous, childhood-onset neurodevelopmental     disorder. Due to its high heritability and severe long-term impairment without available     laboratory diagnosis, effective prevention or treatment, this disastrous disease has been     prioritized for molecular genetic studies. Recent CNVs investigation to identify rare     variants and GWA study with endophenotype approaches are promising strategies to identify     common genetic variants. In addition to intermediate phenotypes such as head circumstance,     speech delay, social impairments and stereotyped behaviors, evidence has demonstrated that     neuropsychology and neuroimages may be useful endophenotypes for autism. Dlgap2, Fbxo25, and     Arhgef10 knoutout mice generated from our previous CNV results will be characterized.   "
122887|NCT01677481|"     The study compares radiation exposure parameters between coronary angiography procedures     performed by left wrist, right wrist or groin (femoral) procedure access site   "
122888|NCT01677468|"     The aim of this study was to evaluate whether survival of patients who underwent TACE with     unresectable HCC can benefit from intermediate-levels of embolization.   "
125396|NCT01643811|"     The purpose of this study is to determine whether the extent of gastrectomy and anastomosis     type affect chronic metabolic disease such as diabetes and hypertension in early gastric     cancer patients.   "
122874|NCT01677650|"     The overall objective is to develop a patient oriented research program to efficiently     evaluate the effects of pharmacogenetic variants on the dose-response relationships and     safety of opioids and non-opioid analgesics. If an opioid regimen can be created that     produces excellent opioid analgesia with minimal toxicity related to supratherapeutic opioid     concentrations (i.e., ventilatory depression), other non-opioid analgesics (i.e.,     gabapentin/pregabalin, ketamine, lidocaine, cyclooxygenase inhibitors, etc.) that may     decrease preoperative opioid requirements can be more efficiently and safely evaluated. These     interventions may limit the opioid related toxicities related to effect site concentrations     that are below those required when opioids are the predominant analgesic, such as opioid     related ileus. Methadone's slow elimination clearance and limited pharmacokinetic drug-drug     interactions make it an attractive perioperative opioid. The first step towards personalized     opioid analgesia is to determine the effect of common pharmacogenetic variants that affect     either methadone metabolism (CYP2B6) or opioid elimination.   "
123065|NCT01675167|"     The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is     effective in treating opioid-experienced subjects, with moderate to severe chronic low back     pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period     of time.   "
122875|NCT01677637|"     Osteoporosis is the most common disease of bone and characterized firstly by low bone mass     and secondly, impaired bone microarchitecture structure resulting in reduced strength and     increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal     Osteoporosis Osteoporosis & elderly and senile osteoporosis) and secondary. The most common     form is postmenopausal osteoporosis. It occurs in women after menopause and is associated     with decreased estrogen production, which normally occurs at this age women Osteoporosis     usually occurs after age 50, it is very common in women than in men, and its frequency     increases with advancing age.   "
122876|NCT01677624|"     To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in     Japanese subjects with hypervascular tumor or arteriovenous malformation   "
122877|NCT01677611|"     Animal studies indicate that resveratrol, a phytoalexin enriched in the skin of red grapes     and a constituent of red wine, is associated with longevity likely through the increased     production of a protein, SIRT1.      The trial is a proof-of-concept study primarily designed to examine for the first time in     humans, the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10     patients with T2DM in a randomized, placebo-controlled, double-blind fashion. Secondary     outcomes include measures of AMPK, p-AMPK and GLUT4 expression levels, energy expenditure,     physical activity levels, distribution of abdominal adipose tissue and skeletal muscle fiber     type composition, body weight, HbA1c, plasma lipid subfraction, adiponectin levels and     insulin sensitivity.   "
122878|NCT01677598|"     The purpose of this study is to determine how patients use ustekinumab (label-recommended or     other/missed dose interval) in Asia-Pacific countries.   "
122879|NCT01677585|"     The purpose of this study is to compile real-world clinical outcomes data for the PROMUS     Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element     and PROMUS Element Plus Stent System) in routine clinical practice in China.   "
122880|NCT01677572|"     The primary objective of this study is to evaluate the safety and tolerability of multiple     doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with     prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to     assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18     (18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose     serum concentrations of Aducanumab and to evaluate the immunogenicity of Aducanumab after     multiple dose administration in this population.   "
122881|NCT01677559|"     This phase I trial studies the side effects and the best dose of MLN8237 (alisertib) when     given together with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)     in treating patients with solid malignancies that are metastatic or cannot be removed by     surgery. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as nab-paclitaxel work by killing the cells     or by stopping them from dividing. Giving alisertib together with nab-paclitaxel may provide     a more effective anticancer treatment with fewer side effects.   "
122882|NCT01677546|"     Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models.     Together with wireless communication with blood glucose meter potentially facilitates     achieving the target post prandial glucose levels. In this RCT authors assessed whether use     of wireless communication between compatible devices: MiniMed insulin pump and blood glucose     meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is     the impact of exerting this tool on metabolic control in type 1 diabetic patients.   "
122883|NCT01677533|"     The PROVE aims to test the efficacy of panel management support and educational intervention     in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive     methods for implementing panel management strategies among health care providers in VA     primary care clinics: providing only panel data, providing panel management support, and     providing support plus clinical microsystem-enhancing education and training.It is     hypothesized that the group receiving panel management and educational interventions will     have better smoking cessation and hypertension outcomes than the group receiving only panel     management assistance. It is further supposed that the later will have better smoking     cessation and hypertension patient outcomes than the data-only group.   "
122884|NCT01677520|"     The overall purpose of this study is to enhance identification and isolation of ADSCs and     adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts,     and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used     in aesthetic surgery but tend to disassemble over time. If the investigators can enhance     growth and volume of fat in culture, the investigators could use fat grafts in reconstruction     of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.   "
122889|NCT01677455|"     The purpose of this study is to determine if ganetespib (STA-9090) is effective in the     treatment of patients with HER2+ or triple negative breast cancer who have not received prior     systemic treatment in the metastatic setting.   "
122891|NCT01677429|"     Hypotheses      The investigators hypothesize that among individuals who suffer from panic disorder there is     higher incidence of co-morbid balance impairment than in the healthy population.      The investigators hypothesize that the treatment of panic disorder, through the treatment of     co-morbid balance impairment using virtual reality (VR) exposure therapy environment, is more     effective than the exposure to still pictures from the same scene in VR without balance     challenge or comparing to standard cognitive behavioral therapy (CBT) for the treatment of     panic disorder.      Rationale      This research relies on previous studies, which have shown mutuality between anxiety and     balance impairment, even if only sub-clinical. The VR-based training environment enables     multi-sensorial stimulus in a dynamic interactively changing setting. With the addition of a     cognitive task (dual task distracting the fear), the investigators can add cognitive load and     therefore challenge the control of balance even more. Individuals who suffer from balance     impairment avoid their exposure to many balance-challenging situations - a fact that may     increase their anxiety. The investigators assume that a considerable number of PD individuals     also experience balance control impairments - mostly subclinical ones. Moreover, balance     impairment accompanies other psychiatric disorders, though not enough literature exists on     the subject.   "
122892|NCT01677416|"     Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of     patients with rheumatoid arthritis (RA) and normal controls, determine the association     between ultrasound and global disease activity, function and goniometric measures in patients     with RA and determine the correlation between ultrasound and radiography in the detection of     bone erosion.      Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform,     calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50     healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated     bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power     Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.   "
122893|NCT01677403|"     This is a study to evaluate the efficacy,indications,adverse reactions and resistance of     combined administration of nebulized tobramycin compared with systemic administration alone     in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.   "
122894|NCT01677390|"     This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of     SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell     carcinoma.   "
122895|NCT01677377|"     Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages     of risperidone with clinically stable schizophrenia   "
122896|NCT01677364|"     Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were     randomised into elective induction and spontaneous labour groups only after bishop score was     equal to or more than 6.It was concluded that induction of labour with oxytocin is a     relatively safe procedure in women with low risk heart disease with NYHA class I and II. It     resulted in a similar caesarean delivery rate and was not associated with more maternal and     neonatal complications.   "
122897|NCT01677351|"     Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant     therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular     and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic     effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias     for cataract surgery.   "
122898|NCT01677338|"     This study is a multi-center, open-label comparison study and aimed to evaluate the     preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying     abnormal (delayed) gastric emptying rates in subjects.   "
122899|NCT01677325|"     To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a     Chinese herb formula.   "
122900|NCT01677312|"     This study compares the 19G and 25G needles for procuring tissue samples from the pancreas     during Endoscopic Ultrasound (EUS) procedures.   "
122901|NCT01677299|"     This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes     mellitus.      In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating     concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes     mellitus.   "
122902|NCT01677286|"     The tetracycline antibiotic doxycycline disrupts A beta amyloid fibrils (AB) in Alzheimer's     disease, transthyretin (ATTR) amyloid fibrils in familial amyloidotic polyneuropathy, and     immunoglobulin light chain (AL) amyloid fibrils in transgenic mouse models of disease. If     untreated, amyloid deposits impair organ function, affecting the morbidity and mortality of     patients.      This single-center, twelve-month, open-label, prospective, pilot phase II study aims to     determine whether doxycycline reduces amyloid deposits and improves organ function in     patients with systemic or localized amyloidosis.      The investigators plan to enroll patients with measurable amyloid disease according to     internationally-accepted diagnostic criteria. Patients must have stable organ function at     enrollment. Eligible subjects not receiving active treatments for amyloidosis affecting their     kidneys, heart, aerodigestive tracts, peripheral or autonomic nervous system(s), lungs, eyes,     skin, bladder, or breasts will undergo evaluations at baseline, 6 months, and 12 months - or     more frequently as clinically indicated.      Over 45 years experience indicates doxycycline is a safe, well tolerated antibiotic. The     investigators will use standard grading systems to assess doxycycline response following     twelve months of treatment.   "
122924|NCT01677000|"     Establish an international registry of over 400 patients with deep infections involving the     bone and/or joint from≥20 centers representing all regions of the world with varied hospital     and surgeon practice settings to ensure that registry analyses and research reflect typical     clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare     researchers. Using a data collection platform that minimizes entry burden, collects most     information at the time of surgery, and uses Internet technology to minimize data entry. The     registry will include:        1. baseline patient attributes;        2. surgical approach, implants and technology;        3. hospital course;        4. surgeon and institutional characteristics;        5. longitudinal patient outcome,        6. post-procedure complications and revisions,        7. serum/tissue/drainage samples.   "
135531|NCT01510808|"     Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive     Periodontitis patients.   "
122903|NCT01677273|"     The primary aim is to examine and compare the effects of hydrolyzed casein (HC), intact     casein (IC) and intact whey protein (IWP) on diet-induced thermogenesis (DIT). Furthermore,     to study the effects on appetite regulation assessed by subjective appetite sensations, ad     libitum energy intake and appetite regulating hormones.      Whey and casein differ in absorption and digestion rate, with whey being a fast protein and     casein being a slow protein. When casein undergoes hydrolysis the absorption and digestion     rates approaches the rates of whey. In the present study the importance of absorption rate     and amino acid composition, in regards to energy expenditure and appetite regulation, will be     examined. HC and IC have identical amino acid composition, but differ in absorption rate,     whereas HC and IWP have similar absorption rates, but differ in amino acid composition. We     hypothesize that consumption of HC will increase DIT and fat oxidation to a greater extend     that IC. Moreover, that HC and IWP will increase satiety shortly after protein consumption,     whereas IC will be more satiating after several hours.      The study is a controlled, randomized, 3-arm crossover study. It consists of three visits in     a respiratory chamber separated by at least two weeks. 26 healthy, overweight and obese (BMI     27-35 kg/m2) young men will be enrolled and randomized to the order of the three protein     supplements (HC, IC or IWP). At each visit protein supplements (containing either HC, IC or     IWP) will be served as breakfast, lunch and dinner. Respiratory measures will be obtained     over 24 hours and appetite will be assessed by visual analogue scales and appetite regulating     hormones. Furthermore, ad libitum energy intake will be assessed.   "
122904|NCT01677260|"     This was a single centre, single-blind, randomized, balanced, combined single dose study     under fasting condition and multiple doses study under fed condition with normal     diabetic-meal, two-period, two-sequence cross-over study to to compare the bioavailability of     metformin hydrochloride 500 mg extended release caplet (test drug) and metformin     hydrochloride 500 mg prolonged release tablet (reference formulation).   "
122905|NCT01677247|"     This was a randomized, single blind, two-period, two sequence cross-over study under fasting     condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test     and reference formulations).   "
122906|NCT01677234|"     Blood pressure is typically measured with a non-invasive cuff placed on the upper arm. This     cuff cannot take accurate measurements when the patient's arm is moving. Anesthesia for a     cesarean delivery frequently causes the patient to shiver and their arm to shake, and     sometimes to the extent that blood pressure cannot be measured. A cuff placed on the wrist     may be more effective when a patient is shivering because their lower arm moves less and can     be more easily stabilized. We will be taking simultaneous blood pressure measurements both     just before and during cesarean deliveries in order to compare blood pressure at the upper     arm versus the wrist.   "
122907|NCT01677221|"     This prospective, open-label study will be conducted in 15 healthy subjects per clinical site     ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5     lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up     to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any     adverse events.   "
122908|NCT01677208|"     The purpose of this study is to determine whether Danhong injection is effective in the     treatment of acute ischemic stroke.   "
122909|NCT01677195|"     The primary purpose of the study is to evaluate the effectiveness of a naturally occurring     clay substance (ACCS100) in reducing harmful effects of aflatoxin exposure (a carcinogen) and     fumonisin (a cancer promoter). This clay substance contains of a variety of minerals     including calcium, sodium, potassium, and magnesium. UPSN and similar aluminosilicate     minerals have been regularly used as dietary supplements by humans and animals, and the     safety of this naturally occurring clay substance has been tested in clinical trials. The FDA     treats such minerals or nutritional supplements as a drug when tested for potential of     lessening the likelihood of disease (i.e., potential for mitigating disease).      This study involves the use of an investigational drug called Hydrated Sodium Calcium     Aluminosilicate (ACCS100). Investigational means that the drug has not yet been approved     by the U.S. Food & Drug Administration (FDA) for reducing harmful effects mycotoxin exposure     in humans.   "
122910|NCT01677182|"     To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated     with Bipolar 1 Disorder.   "
122911|NCT01677169|"     The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH)     and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral     blood lymphocytes of cigarette smokers.   "
122912|NCT01677156|"     The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of     Corus® CAD in Real World Clinical Care Settings (PRESET)--was designed as an observational,     post-market, real-world registry to evaluate patterns of care, including referrals to a     cardiologist, cardiac stress testing, CT angio, within the first month after Cours CAD     testing.   "
122913|NCT01677143|"     Pre-emptive local anaesthetics are widely used in laparoscopic surgery, but there is no     really consistent evidence that it is useful. Studies in the literature have shown     contradicting results. At our hospital we are currently using pre-emptive local anaesthetics     in the trocar areas, but as the literature does not give a clear and clinically relevant     answer, we need to find out more. This study aims to see if pre-emptive local anaesthetics     are useful in the setting of our day-case, laparoscopic surgery.   "
122925|NCT01676987|"     To evaluate the efficacy and safety of a fixed-dose, single-capsule     budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both     delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was     Randomized, double-blind, multicenter, phase III, parallel clinical trial.   "
122926|NCT01676974|"     Objectives: Prospectively study the influence of foreign travel and associated risk factors     on the acquisition of AMR in the endogenous microbiota of healthy individuals and the     subsequent persistence of AMR carriage and transmission to household members of these     carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of     bacterial infections in the year after travel (compared to non-carriers). Explore the full     width of AMR genes and transferable genetic elements acquired during international travel.   "
122927|NCT01676961|"     This phase II trial studies how well romiplostim works in increasing low platelet counts in     patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make     platelets after chemotherapy   "
122914|NCT01677130|"     The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea     and refractory hypoxemia caused by various reasons. Although in recent years a variety of     supportive care measures have significant progress, but the mortality rate of patients with     ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with     ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can     improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS     usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion     has heterogeneity. The protective mechanical ventilation strategies chosen by patients with     ARDS in clinical practice are gradually being accepted and applied. The High-frequency     oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal     volume. Compared with conventional mechanical ventilation, HFOV may be able to more     effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and     protective ventilation strategy in ARDS is consistent with an important position in the     treatment of ARDS, but not been widely adopted in clinical practice and is still only as a     salvage treatment. Therefore, this study intends to use HFOV treatment with conventional     mechanical ventilation by matching the cases in patients with ARDS. By comparing the     influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety,     and health economics effectiveness of HFOV are further investigated and adaption time and     parameter settings of HFOV are explored, which provide better treatment options for patients     with ARDS and improve their prognosis.   "
122915|NCT01677117|"     Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate     can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main     cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to     improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical     ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been     challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians     have more choices in the face of hypoxemia, and with the deepening understanding of ECMO,     ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized     by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO     indications and standardizing the implementation of treatment can significantly improve the     prognosis, shorter hospital stays, lower hospitalization costs.   "
122916|NCT01677104|"     Incretins have become a successful drug target in the repertoire of medications used for the     treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on     the vascular system in humans, independent of their glucose lowering actions and data are     only derived from ex vivo studies in animals. Particularly little is known about clinically     relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with     type 2 diabetes.      The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown     product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The     investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the     beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced     by the body.      The study aims to examine the response of GLP-1 and its analogues on small blood vessels and     examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese     individuals and subjects with Type 2 diabetes.   "
122917|NCT01677091|"     The main objective of this study is to test the effectiveness of a rehabilitation program     with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.   "
122918|NCT01677078|"     Repetitive Transcranial Magnetic Stimulation (rTMS) is a non invasive technique which was     shown to be effective in the treatment of major depression.      The dorsolateral prefrontal cortex (DLPFC) is the anatomic target in rTMS studies and the     standard (manual) '5-cm method' for positioning the coil over DLPFC is the reference.     Nevertheless, it has been criticized due to poor targeting accuracies attributed to     inter-subject variability.      Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy.      Preliminary findings suggest that a more reproductible and accurate method, based upon a     neuronavigation system could allow for a better efficacy. This finding has to be replicated     with sound methodology.      Investigator's objective is to compare efficacy on mood of coil positioning based upon a     neuronavigation device versus coil positioning based upon the standard method.   "
122919|NCT01677065|"     To determine whether the bioavailability of the controlled-release test formulation is at     least as high as that for the commercial reference drug.   "
122920|NCT01677052|"     The primary purpose of this registry is to obtain real world clinical use of contact force     measurements during ablation procedures.   "
122921|NCT01677039|"     The study is designed to test whether or not the rate and extent of absorption of oxycodone     from a proprietary controlled-release formulation is significantly affected by     co-administration of alcohol compared with controlled conditions (when the formulation is     administered with water). The primary pharmacokinetic parameters are the peak concentration     of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area     under the plasma concentration-time curve (AUC).   "
122922|NCT01677026|"     The primary objectives of the Registry are to:        1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical          performance to a larger number of centers in the post market phase and        2. Collect additional evidence to support reimbursement and clinical acceptance and long          term follow up   "
122923|NCT01677013|"     The study is aimed to evaluate the safety and efficiency of autologous bone marrow     mononuclear cell transplantation in treating selective patients with type 2 Diabetes     Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote     β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate     local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin     and improve β-cells function.   "
122937|NCT01676831|"     The objective of this study is to explore the safety and the preliminary efficacy of two     concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA)     Cutaneous T Cell Lymphoma patients.      This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Products     Development, FDA.   "
122928|NCT01676948|"     This two-part open-label, multi-arm, non-comparative study will collect long-term safety,     efficacy and tolerability data from patients who were responsive to canakinumab from study     CACZ885G2301E1 (Cohort 1), and from patients who are treatment naïve to canakinumab (Cohort     2). In addition, the effect of inactivated vaccines in an SJIA patient population will be     assessed for the development of adequate (protective) antibody levels following immunization     according to respective local vaccination guidelines.      Study Part I:      All patients will be treated with canakinumab 4 mg/kg every 4 weeks (or 2 mg/kg every 4 weeks     for Cohort 1 patients who are receiving that dose in CACZ885G2301E1) until study end unless     discontinuation occurs, or until they qualify for Part II of the study.      Study Part II:      Patients who are eligible will be randomized to receive canakinumab at a reduced dose or     prolonged dose interval (see requirements for dose reduction/dose interval prolongation     below).      Patients in Cohort 1 receiving 2 mg/kg q4wk in CACZ885G2301E1 will not be randomized but will     be part of the treatment arm canakinumab dose reduction if they are eligible.   "
122929|NCT01676935|"     This is a long term extension study to evaluate safety and tolerability of subjects who     complete study M10-985 which is evaluating a new treatment for subjects with mild to moderate     Alzheimer's disease.   "
122930|NCT01676922|"     This observational study will evaluate the use of Avastin (bevacizumab) and conventional     chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal     cancer. Data will be collected from each patient from initiation of treatment until disease     progression occurs (minimum follow-up 12 months).   "
122931|NCT01676909|"     Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress     Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in     increased risk of disability, high health care spending, reduced quality of life and early     mortality. Physical wellness is increasingly recognized as a key component of the VA's     commitment to developing recovery-oriented and Veteran-centered mental health treatment.     There is also growing recognition of the value of interventions that promote and improve     patient self-management of chronic medical conditions. Building on the established efficacy     of consumer facilitated medical illness self-management programming used in the general     population and two recent adaptations for use with SMI adults in the public health sector     (including the investigators' own evaluation of an intervention called Living Well), the     investigators propose to complete a randomized controlled effectiveness trial of the Living     Well intervention and simultaneously conduct a well specified process evaluation to optimize     knowledge accrual regarding important factors that may improve future adoption,     implementation and sustainability of the Living Well intervention in the VA system of care.   "
122932|NCT01676896|"     Asthma is the most common chronic childhood illness and disproportionately affects children     who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with     children who live in rural areas or have included Mexican American children in their samples.     This study builds on the original R01NR007770 with findings that demonstrated the     intervention could improve children's asthma self-management, asthma knowledge, metered dose     inhaler skill, asthma severity, and parents' asthma management and access to care. In this     competing continuation, the investigators added a third arm to the current research design     with schools randomized into either an in-school asthma intervention, an in-school     attention-control intervention, or an alternate intervention-delivery format of a single     5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American,     African-American, and White rural school-aged children (grades 2-5) who have asthma and their     parents. In addition, the investigators propose adding a non-invasive measure of chronic     airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma     management on airway inflammation. Families will be followed for a full year with data     collection at baseline and at 1-month, 4-months, and 7-months after the intervention to     assess improvement in children's asthma morbidity, asthma severity, airway inflammation,     family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop     group and the School-Home group will demonstrate equivalent improvements, but greater     improvements than the Attention-Control group in:(H1.1) their asthma severity and airway     inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office     visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time     4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms     will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the     pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to     the Attention-Control group.   "
122933|NCT01676883|"     Studies have confirmed the association between plantar callosities and severely obese     individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for     estimating body composition because it is easy to use, noninvasive, relatively inexpensive,     and can be performed across a wide range of subjects.      Our hypotheses for this study are: (1)plantar callosities influence the body composition     measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the     percentage of body fat compared with air-displacement plethysmography (BodPod).   "
122934|NCT01676870|"     The primary objective of the study is to compare in a real-world setting the efficacy of     traditional training (today's guideline, vigorously or moderate exercise) and amount of     aerobic interval training (1-AIT) in reduction of risk factors constituting metabolic     syndrome.      The secondary objective is to compare the efficacy of traditional moderate training (today's     guideline) and amount of aerobic interval training (1-AIT vs. 4-AIT) in improving aerobic     capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle     energy metabolism, left ventricle systolic and diastolic function at rest and right     ventricular function.      The investigators hypothesized that aerobic interval training would reverse features of the     metabolic syndrome more than traditional training.   "
122935|NCT01676857|"     The purpose of this study is to identify biomarkers that can be utilized in the diagnosis of     chronic pelvic pain syndrome in men.   "
122936|NCT01676844|"     There is a deficit in the number of 'age-appropriate' formulations available for the delivery     of medicines to children. Liquid preparations are considered the 'gold standard' for     delivering medicines to children however many of these are formulated using ingredients which     can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal babies (< 4     weeks old) who do not possess the metabolic processes and mature organ function of older     children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in the saliva,     releasing the active ingredient(s) without the need for chewing or water, making them ideally     suited to patients who find it difficult to swallow other oral dosage forms such as tablets     or capsules. The aim of this study is to demonstrate that OTFs can offer a safe and effective     alternative for oral administration of phosphate supplements to neonatal infants for the     treatment of hypophosphataemia and osteopenia of prematurity. It is hypothesised that this     treatment will be equal to standard therapy using an oral solution. Babies born before 32     weeks gestational age are routinely supplemented with oral phosphate as soon as they have     been established on oral feeds in order to prevent bone disorders such as osteopenia. Babies     recruited to this study will be given phosphate supplementation as per NHS Greater Glasgow     and Clyde guidelines. This single-centre cross-over study will take place in the intensive     care and special care baby units at the Princess Royal Maternity in Glasgow. The     investigators aim to recruit 20-30 babies and will use blood phosphate levels (obtained from     routine sampling only) to evaluate treatment effect. Babies will be randomised to receive     either OTFs or oral solution of potassium acid phosphate for 2 weeks followed by 2 weeks of     the other therapy. The investigators hypothesise that OTF treatment will be equivalent to     standard oral solution.   "
122939|NCT01676805|"     Background:      - Lab studies help researchers better understand cancer biology. This information may lead to     new methods for diagnosing or treating cancer. To develop these studies, researchers want to     collect samples from people with cancer or precancer conditions of the lymph system. These     conditions include multiple myeloma, different types of lymphoma, and adult     leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor     and skin tissue.      Objectives:      - To collect tissue samples to study different types of lymph cancer.      Eligibility:      - Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Different samples will be collected for study. Blood samples will be collected at the          initial testing. More blood samples will be collected at different treatment points.          Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue          and skin tissue biopsies will also be collected for study.        -  Treatment will not be provided as part of this study.   "
122940|NCT01676792|"     This pilot clinical study is to evaluate the efficacy & safety of SR-T100 gel (2.3% of SM in     Solanum undatum plant extract) in patients with VIN(s) or EGW(s).   "
122941|NCT01676779|"     This is an open label, 2-arm, 1-stage, randomized controlled phase II study in patients with     AJCC stage IIIB/C & -IV melanoma. At baseline tumor assessment (using total body FDG-PET/CT),     patients should be free from measurable tumor lesions (according to RECISTv1.1 definitions)     following prior local therapy (e.g. following surgical resection, isolated limb perfusion,     radiofrequency ablation, cryotherapy, radiotherapy, electrochemotherapy, …). Patients should     not have symptomatic non-measurable tumor lesions (e.g. bone metastasis, or pleural     effusion), and lesions treated by prior local therapy should be free from progression.     Patients should not have received any prior systemic therapy (non-experimental or     experimental).   "
122942|NCT01676766|"     The purpose of this study is to utilize flavoprotein fluorescence and fundus autofluorescence     to detect progression of Stargardt macular dystrophy in a pediatric population over the     course of a year with the hope of aiding future therapeutic risk-benefit decisions and     assessment of outcomes.      Stargardt macular dystrophy is the most common of the juvenile-onset macular dystrophies.     Despite determination of ABCA4 as the causative gene, clinicians have been challenged by     variability in clinical phenotypes. Given the recent initiation of clinical trials to assess     novel treatments (e.g. gene therapy), there is a need to identify patients with the worst     prognosis.      The investigators have observed that pediatric patients lose central visual function faster     than their adult counterparts. Thus, they present an ideal cohort with which to determine the     utility of novel modalities to detect early change. These include flavoprotein fluorescence,     a new imaging technique for detecting mitochondrial dysfunction developed at the University     of Michigan. Fundus autofluorescence (FAF) is another commonly utilized technique of     evaluating hereditary eye diseases. The investigators have developed a novel means of     quantifying FAF signatures that will allow documentation of severity as well as detection of     progression.   "
122943|NCT01676753|"     The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose     (MTD)) of weekly dinaciclib in combination with every 3 week pembrolizumab in patients with     advanced breast cancer. Once this is defined, a 20 patient dose expansion will be performed     at this MTD in patients with metastatic or locally advanced and unresectable triple negative     breast cancer, to evaluate the efficacy of combined dinaciclib and pembrolizumab.   "
122944|NCT01676740|"     To establish the efficacy of screening for anemia and treatment of mild anemia with iron and     vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative     allogeneic blood transfusion.   "
122945|NCT01676727|"     This study is intended to collect data regarding the clinical utility, safety and performance     of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in     patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic     access (DA) is selected. As part of the study analysis, resource utilization together with     the Quality of Life questionnaires data will provide an important input into cost     effectiveness analysis.   "
122946|NCT01676714|"     The purpose of this study is to find out if dovitinib is an effective treatment for patients     with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on     anti-vascular endothelial growth factor (VEGF) treatment.   "
122947|NCT01676701|"     The purpose of this study is to evaluate the serum concentration of tabalumab after the     administration using either prefilled syringe or auto-injector after the initial loading dose     and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety     extension.   "
122948|NCT01676688|"     The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at     home or in out-of hospital locations.   "
122949|NCT01676675|"     Influenza is an acute respiratory infection caused by influenza virus with high incidence and     serious complications even causing death. According to the announcement released by the World     Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion     and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus may cause     an influenza pandemic with occurence once every 10 to 50 years which cause serious adverse     consequences for human health and social welfare worldwide.      From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to     Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has     attracted the WHO and national government great attention. So it is meaningful to develop     vaccine to provide effective antibody to reduce the number of infections.      The objective of this study is to evaluate the safety and preliminary immunogenicity of a     whole virus inactivated influenza H5N1 vaccine.   "
122950|NCT01676662|"     The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace     Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence     (SUI) in adult females.   "
122951|NCT01676649|"     The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two     different dosing schedules will be investigated in patients with metastatic melanoma. This     protocol will also investigate both the clinical benefit of this combination and the features     of the host immune system that may predict response to ipilimumab with chemotherapy in     patients with unresectable Stage III and Stage IV melanoma.   "
122952|NCT01676636|"     The SickKids-led research team is currently developing a prenatal micronutrient powder that     will contain calcium, iron, and folic acid with different absorption characteristics. Once     the powder is developed, it can be incorporated into various oral delivery vehicles. The     overall effectiveness of a micronutrient program is highly dependent on the acceptance and     regular consumption of supplements (i.e., adherence) by the targeted users. This is a study     of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the     innovative prenatal multiple micronutrient supplement: traditional tablets, oral     disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with     a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study     hypothesizes that that the formulation of the delivery vehicle will impact preference,     acceptability, and palatability.   "
122953|NCT01676623|"     Alive & Thrive is an initiative that aims to improve infant and young child feeding practices     and reduce childhood stunting. In Vietnam, Alive & Thrive's primary intervention is     implemented through a social franchise linked with the government's health system. The impact     evaluation is conducted using a cluster-randomized design in which 20 commune health centers     (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine     government services. Repeated cross-sectional baseline and endline surveys will be used to     assess the public health impact of this intervention. The baseline was in 2010 and an endline     survey in the same communities will be conducted in 2014. Mixed methods process evaluation     will be conducted in 2011, 2012 and 2013 to study the pathways through which the program     impact is achieved.   "
122954|NCT01676610|"     Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign     of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid,     portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation     (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting.     In this research study, we propose to test the hypothesis that the use of pulse oximetry to     detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible     for the identification of the infants most urgently in need of medical care. We will enroll     1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi.     Infants will undergo brief clinical assessment by a community health worker (CHW) based on     the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm,     assessment by two pulse oximetry devices, and examination by a physician. The primary     outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain     measurement, number of infants for who repeat measurements are required), and concordance     between paired measurements on separate devices.   "
122955|NCT01676597|"     -  The study will be a prospective open labelled double blinded randomized controlled          study.        -  The study will be conducted on patients admitted to Department of Hepatology from 2012          to 2014 at Institute of Liver and Biliary Sciences, New Delhi        -  Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be          started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.        -  Patients not responding to this therapy will be given divided into 2 arms with one arm          receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.   "
122956|NCT01676584|"     This randomized, double-blind, placebo-controlled study will evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers.     Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135     or placebo subcutaneously.   "
122957|NCT01676571|"     The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu     AA21004 (Vortioxetine) in the Chinese population.   "
122958|NCT01676558|"     Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in     Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use     aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status,     refractoriness, and relapsed disease still remains. So we investigate the efficacy of     radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.   "
122959|NCT01676545|"     (A retrospective case control study to validate the association between Interleukin-1 gene     variations and adult chronic periodontal disease in Chinese (Shanghai))   "
122960|NCT01676532|"     This is a prospective cross sectional study to assess the feasibility of a school based     health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in     Toronto. The SBHC allows inner-city children who face barriers to accessing health care the     opportunity to receive health care in their school.The primary aim of this study is to     determine utilization of the SBHC. Establishing feasibility of the SBHC would support further     development and expansion of this program into other inner city schools.   "
122961|NCT01676519|"     Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary     intervention (PCI) in whom development of critical limb ischemia was prospectively assessed     by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary     endpoint of the study.   "
122962|NCT01676506|"     Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis)     treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).   "
122963|NCT01676493|"     This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate     in pediatric subjects with mild to moderate post-procedural pain.   "
122964|NCT01676480|"     The purpose of the present study is to investigate if endurance training can be used as a     therapeutic action against the adverse metabolic disturbances and unfavourable changes in     body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate     cancer patients.   "
122965|NCT01676467|"     This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers     and normal healthy subjects, to compare the biological markers of disease and inflammation.   "
122966|NCT01676454|"     The purpose of this study is to determine if vasopressin is used up by the body during     traumatic shock (severe low blood pressure due to trauma).   "
122967|NCT01676441|"     This phase II/III clinical trial is designed to evaluate the safety and efficacy of     autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.   "
122968|NCT01676428|"     This is a proof of concept study, to assess the feasibility of introducing a novel     high-precision radiotherapy technique called stereotactic radiosurgery (SRS) or     stereotactic body radiotherapy (SBRT) for the treatment of kidney cancers in Australia.     This study aims to invite 20 patients with renal cell carcinoma and 10 patients with isolated     adrenal metastases from non-small cell carcinoma who are either medically inoperable, high     risk for surgery, or decline surgery to participate. In cohort of patients with renal cell     carcinoma, both patients with primary disease only, and those patients who have limited     metastases (≤5) will be eligible. Besides technical feasibility of delivering this treatment,     this study will be to assess efficacy, toxicity and tumour response using a novel imaging     biomarker called diffusion weighted-MRI.   "
122969|NCT01676415|"     The purpose of this study is to determine the most effective route to administer steroids to     patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with     nasal polyps (CRSsNP). The investigators would like to better understand whether orally     administered steroids results in superior results when compared with nasally sprayed     steroids. The investigators propose to test the hypothesis that for patients with     radiographically proven CRSsNP, routine medical therapy consisting of a short course of     systemic corticosteroids is superior to topical corticosteroids for relieving inflammation     and the symptoms of CRS.   "
122970|NCT01676402|"     This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety,     tolerability, and immunogenicity of same season and sequential season vaccination schedules     consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent     influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The     hypothesis is that evaluation of these investigational schedules will inform development of     novel influenza vaccine strategies that may offer improved and cross-protective immunity     against antigenically diverse influenza strains.   "
122971|NCT01676389|"     The purpose of this study is to determine how osteopathic manual medicine (OMM) will affect     core autism features including social and communication deficits. The investigators believe     that OMM approaches can positively influence some features associated with Autism/Autism     Spectrum Disorder (ASD).   "
122972|NCT01676376|"     Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate     feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an     external vein support device for use over saphenous vein grafts during coronary artery bypass     surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh     (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study     subject will receive one SVG with the eSVS Mesh.   "
122973|NCT01676363|"     Diflunisal is an anti-inflammatory drug (like ASA or ibuprofen) that has been used as a     painkiller for 20 years. Recent research shows that it may have an anti-HIV effect in the     laboratory. Approximately 20 HIV-infected adults who are not receiving antiretroviral therapy     will be given diflunisal by mouth twice daily for 4 weeks, at a dose that has been shown to     be safe when used to treat pain. Subjects will be monitored closely for safety and will have     frequent blood tests during the study to see if the drug has any effect on the level of HIV     in their blood.   "
122974|NCT01676350|"     By doing this study, the investigators hope to learn whether patients with difficult to     obtain IV access who are treated with IO access are more satisfied with their care and have     better outcomes. The investigators are specifically studying the time difference between     groups and the difference in the number of attempts required to obtain vascular access and     begin to treat with fluids and medications. The study will also measure patient satisfaction     and procedural pain, the frequency of central line placement, the length of stay in the     hospital and emergency department, and adverse events to intravascular access to determine     whether IO access can improve these measures.      The investigators hypothesize that the use of a protocol utilizing an IO device for select     patients with failed IV access will reduce the time requirements to obtain vascular access,     reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no     negative impact on patient satisfaction compared to the current ED practices.   "
122975|NCT01676337|"     This project proposes administer and evaluate via a randomized controlled trail a text     message-based appointment reminder system to promote attendance at clinic appointments after     ED discharge.   "
122976|NCT01676324|"     Hypothesis:      Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with     Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to     colonoscopy in the management of patients with Inflammatory Bowel Disease.      Objectives:      By means of a survey from the ordering physician we would assess:      Primary Endpoint      1. The Percentage of time that the Fecal Calprotectin result caused the physician to change     the management of a patient.      Secondary Endpoints        1. To determine if the Fecal Calprotectin result influenced the number of endoscopies          performed        2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when          endoscopy was performed.        3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured          by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if          endoscopy was performed).   "
122977|NCT01676311|"     We will explore the use of Huperzine A in patients who have sustained a moderate to severe     Traumatic Brain Injury. We aim to determine whether Huperzine A, as compared with placebo,     would have an effect on memory function after TBI. Additionally, we aim to determine whether     use of Huperzine A in these patients can change brain activity (as indexed by EEG and     Transcranial Magnetic Stimulation - TMS), and reduce prevalence/frequency of post-traumatic     seizures. We also aim to evaluate the safety of Huperzine A in this population as compared     with placebo.   "
122978|NCT01676298|"     The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a     qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and     *17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study     is to evaluate the performance of the FRX System under multivariate conditions including     different days, sites, operators and systems.   "
123458|NCT01670019|"     This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing     antidepressant treatment in patients with major depression who have not had a complete     therapeutic response to treatment with the antidepressant alone.      The investigators hypothesize that added asenapine will produce greater reductions in     depression than will added placebo.   "
122979|NCT01676285|"     Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with     cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of     complications in liver disease. The purpose of this prospective, randomized trial is to     determine whether metoprolol succinate can revert cardiac dysfunction secondary to cirrhosis     (cirrhotic cardiomyopathy), and prevent complications (renal dysfunction, mortality). A total     of 100 patients with cirrhotic cardiomyopathy will be randomized (Group R) to receive     metoprolol succinate or placebo; other 25 patients without cirrhotic cardiomyopathy (Group F)     will only be followed up without medication. All patients will be evaluated in the beginning     and again after six months. The assessment protocol includes clinical evaluation,     electrocardiogram, echocardiogram, laboratory analysis and life quality questionaire. The end     points will be cardiac remodeling, electrophysiologic changes, sympathetic activity,     laboratory issue changes, renal function, quality of life, and mortality.   "
122980|NCT01676272|"     Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers,     data comparing one type of modality to another are scarce. This investigation is a     prospective randomized study comparing a bioengineered skin substitute to a human skin     allograft.   "
122981|NCT01676259|"     In this Phase II study a single dose 2.8 mg (eight 0.35 mg siG12D-LODERs) will be     administered to patients with unresectable locally advanced pancreatic cancer combined with     chemotherapy treatment.      Primary Outcome:      - Progression-free survival (PFS) in the study population.   "
122982|NCT01676246|"     Flupirtine is metabolized in-vitro via carbamate cleavage and N acetylation to glucuronides     and mercapturic acid derivatives. The formation of reactive, toxic intermediate products may     be influenced by genetic polymorphisms of the involved conjugative metabolic pathways. So the     purpose of this study is to measure pharmacokinetics, metabolism and analgesic effects of     flupirtine in dependence on the function of NAT2, UGT1A1 and GSTP1.   "
122983|NCT01676233|"     Primary Objective:      - To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a     new formulation of insulin glargine and Lantus at steady state      Secondary Objectives:        -  To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose          (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;        -  To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters          (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));        -  To compare the occurrence of hypoglycemia between the 2 treatments;        -  To assess the safety and tolerability of a new formulation of insulin glargine.   "
122984|NCT01676220|"     Primary Objective:      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of     change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants     with type 2 diabetes mellitus      Secondary Objectives:      To compare a new formulation of insulin glargine and Lantus in terms of:      - occurrence of nocturnal hypoglycemia   "
122985|NCT01676207|"     In contrast to the extensively studied coronary collateral circulation within the heart,     clinical attention has been paid only anecdotally to extracardiac-to-coronary anastomoses.     Usually this has been in the form of case reports giving account of angiographically visible     anastomoses between the coronary circulation and the internal mammary artery (IMA), typically     in the presence of a chronic occlusion of a coronary artery. In the anatomical literature,the     most common types of extracardiac anastomoses include bronchial-to-coronary-artery and     IMA-to-coronary-artery connections. Anastomoses between the IMA and the coronary circulation     have been documented to occur in 12% of post-mortem patients with CAD.      Importantly, hitherto existing observations typically have relied on visual methods     insensitive for the adequate detection especially of structurally present but poorly     functional anastomoses. On a diagnostic coronary angiogram, collaterals are visible only if     the recipient vessel is subtotally stenotic or fully occluded, or can be rendered visible     during coronary spasm or by temporary balloon occlusion of the recipient artery and     simultaneous injection of contrast medium into the other arteries, respectively. Similarly,     the macroscopic pathologic postmortem examination is likely to underestimate the true number     of extracardiac coronary collaterals.      The purpose of this study is to determine the in vivo prevalence and functional distribution     of IMA-to-coronary collateral supply via both the right and the left coronary artery.   "
122986|NCT01676194|"     The hope to treat more patients with hepatocellular carcinoma successfully is however     tempered by the shortage of donors leading to an increasing waiting time for liver     transplantation (LT). Intention-to-treat analysis have showed that the reported excellent     long-term outcome is curtailed and significantly hampered by the growing incidence of     patients who must be removed from the waiting list because of tumor progression. A way to     face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic     options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most     common modality used. While there are many studies concerning TACE in this setting, none are     controlled studies and thus there is no firm evidence concerning its efficacy in reducing     drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial     complications…) while waiting for LT. Most of the available data have been based upon     analysis of patients who received a transplant and have not included patients who were     eligible for LT but died, or showed progression, before it could be performed. Therefore,     studies conducted on an intention-to-treat basis are needed to clarify the benefit and the     risks of TACE prior to LT in patients with hepatocellular carcinoma.   "
122987|NCT01676181|"     Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in     treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.   "
122988|NCT01676168|"     Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.   "
122989|NCT01676155|"     To compare the serum apoptosis-associated markers between patients with active TB and     patients with LTBI To evaluate the efficiency of apoptosis-associated markers to     differentiate potential of active TB from LTBI   "
122990|NCT01676142|"     1. To compare TLR-2 expression of peripheral blood mononuclear cells and serum downstream          cytokines in those with MAC or MAB pulmonary infection and those with MAC or MAB          pulmonary colonization and controls.        2. To investigate the response of TLR-2 expression and cytokines activation to NTM          stimulation test in patients with MAC or MAB pulmonary infection and colonization and          controls.        3. To validate the NTM stimulation test for NTM pulmonary infection.   "
122993|NCT01676103|"     The objective of this experiment is:        -  Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension          in people with PD.        -  Secondary: To determine the effects of tyrosine supplementation in people with PD with          autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise          stress.      Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who     suffer from PD, especially as it leads to lightheadedness and falling. For those affected, it     can drastically reduce quality of life. It has been hypothesized that tyrosine may impact     upon individuals suffering from PD. There is ample evidence in animal models that supports     our theory; however there is no clinical evidence of the impact tyrosine supplementation may     have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses.     Positive findings that supplemental tyrosine increases BP and HR in people with PD during     daily activities such as standing up from a chair and walking can lead to new therapies to     improve Parkinsonian orthostatic hypotension.      Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine     therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve     after tyrosine supplementation.   "
122994|NCT01676090|"     To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like     growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex     and pubertal stage of a healthy paediatric Spanish population.   "
122995|NCT01676077|"     The Clinical Outcome Study for Dysferlinopathy is being performed in centres in Europe (UK-     Newcastle; Spain- Barcelona, Sevilla; Germany- Berlin, Munich; Italy- Padova; France- Paris,     Marseille), USA (Charlotte, NC; Columbus, OH; Washington, DC; St.Louis, MO, Stanford CA),     Japan (Tokyo) and Australia (Sydney). Oversight and funding for this study is being provided     by the Jain Foundation, a non-profit foundation dedicated to finding therapies for     dysferlinopathies(LGMD2b/Miyoshi). The aim of this Clinical Outcome Study is to determine     the clinical outcome measures required for future clinical trials, characterize the disease     progression of dysferlinopathy and collect biological samples for the identification of     disease markers that are needed to non-invasively monitor the disease during clinical trials.     Without this information, effective clinical trials cannot be performed.      This study is recruiting a large number of genetically confirmed dysferlinopathy patients     aged 10 years or older, who are ambulant or non-ambulant. Participants will be assessed at 6     visits over 3 years via medical, physiotherapy, and MRI/MRS assessments, as well as standard     blood tests. Optionally, the participants can donate blood samples and a skin sample for use     in the identification of disease markers and other approved research.   "
122996|NCT01676064|"     The aim of this study was to quantify the Intraocular Pressure (IOP) changes in patients     undergoing laparoscopic hysterectomy at different time points and body positions throughout     the procedure, and to explore the influence of perioperative fluid management on the     fluctuations of IOP during perioperative period.   "
122997|NCT01676051|"     The purposes of this study are to identify the common bacterial flora on the hand and     evaluate the efficacy of readily available skin-preparation solutions in the elimination of     bacterial pathogens from the surgical site following skin preparation. The null hypothesis is     that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in     pre-operative skin preparation in clean, elective hand surgery cases.   "
122998|NCT01676038|"     The success of total knee arthroplasty depends on a number of factors including pre-operative     range of movement, obesity, medical comorbidities, prosthesis design, preparation and     implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal     placement of the implants within 3° of the mechanical axis of the lower limb has been proven     to reduce wear and early implant failure.      Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has     been widely used in the last decade and have been proven to improve the accuracy of     prosthesis placement and lower limb alignment by reducing the number of outliers with more     than 3° deviation from the mechanical axis. However, its use also involves a steep learning     curve, high initial capital cost and longer duration of surgery.      Traditional computer-navigated TKA using optical tracking systems also requires fixation of     the femoral and tibial reference arrays to bone using anchoring pins. Complications reported     with the use of these pins include either femoral or tibial fracture, pin site pain, pin site     infection and osteomyelitis. The investigators study aims to investigate the accuracy of a     new pinless navigation system for TKA that will avoid these complications.   "
122999|NCT01676025|"     The purpose of this study is to compare two surgical methods of adrenalectomy. One is called     PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at     patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through     patient's abdominal cavity after making 3 or 4 holes in the abdomen.   "
123000|NCT01676012|"     Through technological improvement a new technique has become available in the form of     high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the     standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers     only. The impact of this development with high-definition videobronchoscopy using a 1.1     megapixel chip on the diagnostic performance of bronchoscopy is however unknown.      The aim of the present study therefore is to explore the diagnostic performance (sensitivity     and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering     technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode     SAFE3000 autofluorescence videobronchoscopy in a high risk population.   "
123023|NCT01675713|"     The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1     year) term effects on body composition and psychological health after a 10 to 14-weeks     comprehensive lifestyle modification program for the treatment of severe obesity.      The aims of the PhD project are to investigate whether an intensive lifestyle intervention     leads to acute and short term (< 1 year) changes in:        1. The BMI/Weight        2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and          visceral fat area)        3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and          health-related quality of life   "
123648|NCT01667536|"     This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and     performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic     lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI     were also assessed, as judged by histopathology results.   "
123001|NCT01675999|"     In patients with locally advanced colon cancer (high risk stage II and stage III), curative     surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However,     for 30-40% of these patients, the current curative treatment strategy of surgical excision     followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate     distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an     attractive concept for locally advanced colon cancer and has the potential to impact upon     both of these causes of failure. Optimum systemic therapy at the earliest possible     opportunity may be more effective at eradicating distant metastases than the same treatment     given after the delay and immunological stress of surgery. Added to this, shrinking the     primary tumor before surgery may reduce the risk of incomplete surgical excision, and the     risk of tumor cell shedding during surgery.      ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response     rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone     and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon     cancer. Control arm includes patients for whom standard treatment comprises surgery followed     by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a     neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most     effective in terms of response rate.   "
123002|NCT01675986|"     The insertion of long-lasting intravenous device is done under local anesthesia. Currently,     in the investigators hospital, no premedication is given to the patients. However, this     procedure occurs in a particular emotional context related to the diagnosis of cancer or     malign hemopathies.      Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure     can be questionable.      Hydroxyzine is the reference molecule for premedication because of its anxiolytic and     anti-histaminic properties A new agent, pregabalin, shares also the same properties      The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on     the anxiety score as a premedication during the insertion of long-lasting intravenous device     under local anesthesia.   "
123003|NCT01675973|"     The purpose of this study is to assess the effect of severe renal impairment on the     steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with     normal renal function.   "
123004|NCT01675960|"     This study is a prospective, randomized, double blind, placebo controlled, crossover clinical     trial looking at whether gabapentin can provide symptom relief for chronic irritability in     neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and     safe for children with chronic irritability that persists despite identification and     appropriate management of symptom sources.   "
123005|NCT01675947|"     This study will seek to enroll 50 persons who have central or non-central geographic atrophy     (GA) associated with age-related macular degeneration (AMD). GA in treated eye must be     between 0.75 disk areas (DA) and 8 DA. Eligible participants will be randomly chosen to     receive one of the following treatments in the study eye:        1. A 20 μL (440 μg) intravitreal (IVT) injection of sirolimus, or        2. A sham treatment (subconjunctival injection of lidocaine) Participants with two (2)          eligible eyes will have one eye randomly assigned to receive intravitreal sirolimus and          no sham in the fellow eye.      The first injection will begin at Day 0, which may occur on the date of screening/enrollment     or up to two weeks following screening/enrollment visit, and every month thereafter. The     visit schedule is as follows:        1. A clinical evaluation, including safety measures, will occur monthly.        2. Vision will be measured at the screening/enrollment visit and at 2, 3, 6, 9, 12, 18 and          24 months after the first injection has occurred.        3. Fundus autofluorescence will occur at screening/enrollment and at 2, 6, 12, 18 and 24          months after the first injection has occurred.        4. Fundus color photography and optical coherence tomography will occur at          screening/enrollment and at 6, 12, 18 and 24 months after the first injection has          occurred.      The primary goal is to evaluate whether the persons receiving the sirolimus injections show a     slower worsening of geographic atrophy compared to the persons receiving the sham injections.     A secondary goal is to evaluate the impact of sirolimus on vision compared to the sham.      NOTE: As of May 30, 2014, study injections were discontinued due to safety concerns. No     further enrollments will occur and follow-up will continue on all active study participants     on a quarterly basis. That is, on visits coinciding with 3 month intervals from date of     enrollment.   "
123006|NCT01675934|"     Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in     the proximal colon compared to the distal colon. Possible reasons for this include bowel     preparation often being worse in the proximal colon as well as flat depressed lesions being     more common in the proximal colon.      Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the     proximal colon is not currently routinely performed due to concerns of perforation and     possibly because of the increased time required.      Proximal colon retroflexion has been shown to be safe and effective without any     complications, but data regarding ability to retroflex with certain types of colonoscopes is     limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric     colonoscopes. Studies have not been performed to comparatively evaluate the success rates of     standard adult and pediatric colonoscopes and whether either type of instrument confers a     greater polyp detection rate.   "
123007|NCT01675921|"     The investigators hypothesize that at the end of the 12-month trial, teenagers regularly     self-monitoring their asthma control with ACT administered through Facebook will have     improved ACT scores as compared with teenagers receiving usual care.   "
123008|NCT01675908|"     Compare the performance of full covered metal stents and plastic stents for preoperative     biliary decompression   "
123009|NCT01675895|"     The main objective was to test the hypothesis that adding lidocaine to hyperbaric     levobupivacaine could change the duration of levobupivacaine spinal block.   "
123010|NCT01675882|"     The objectives of this dose-finding study for the treatment of peanut allergy are:        -  To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg          peanut protein per patch) to significantly desensitize peanut-allergic subjects to          peanut after 12 months of treatment.        -  To evaluate the safety of a long-term treatment with Viaskin Peanut.   "
123011|NCT01675869|"     The purpose of this study is to see if an intervention training executive functions like     attention, working memory, and self-regulation for preschoolers at risk for     Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves     attention, behavior, and functioning.   "
123024|NCT01675700|"     The purpose of this study is to determine whether a topical nitroglycerine patch applied     daily over a trapezius trigger point can improve patients' symptoms.      If there is improvement, this open label study will help determine the degree of improvement     and contribute to the design of a larger double blind placebo controlled trial.      We would consider moving forward to a large randomized trial if:        -  The intervention is acceptable to patients (>= 70%) and        -  Compliance is satisfactory (>=80%) and        -  We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the          VAS.   "
123012|NCT01675856|"     Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The     condition accounts for 150 per 100,000 populations. A National United Kingdom reported a     crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of     patients at their presentation, there remains a subgroup of patients who continue to bleed or     develop recurrent bleeding. In these patients, the mortality increases manifolds. If these     high-risk patients can be identified, early interventions may improve their outcomes.      Several prognostic indices are in use for the purpose of patient stratification. They include     the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite     score which incorporates clinical parameters as well as findings during endoscopy which was     derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the     prediction for the need of further intervention loosely defined as the need for transfusion,     endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for     early discharge.   "
123013|NCT01675843|"     The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy     rates in women with polycystic ovary syndrome. Infertile women with pcos will receive     gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse     (TI)   "
123014|NCT01675830|"     This is a phase I descriptive pilot study to determine the feasibility of using the Heat     Retention Head Wrap on infants during the re-warming period following cardio-pulmonary     bypass.   "
123015|NCT01675817|"     Recent work has shown that heparin rebound is common after cardiac surgery.      The exact doze of protamine required to neutralize heparin at the end of CPB is unknown.     Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also     unknown if precise titration of protamine perioperatively in cardiac surgery can influence     transfusion requirements after cardiac surgery.   "
123016|NCT01675804|"     Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation     (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of     children with attention deficit/hyperactivity disorder (ADHD).   "
123017|NCT01675791|"     The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree     AIT administered once daily in order to define a dose-range that would be suitable for     at-home administration.   "
123018|NCT01675778|"     Pain is the most common complaint for patients presenting to the emergency department (ED).     Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and     responses to intravenous opioids vary widely and are influenced by multiple factors. The     objective of the current study is to examine the association between total body weight, BMI     (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.   "
123019|NCT01675765|"     This clinical trial will evaluate the safety and immune response of the sequential     administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard     of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of     Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause     disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been     engineered to elicit an immune response against the tumor-associated antigen mesothelin,     which has been shown to be present at higher levels on certain tumor cells (such as     mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy     regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving     CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or     objective tumor response.   "
123020|NCT01675752|"     1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol     Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and     adenomatous <10 mm polyps with that of histology in an European multi-center study. To assess     variability among endoscopists in NBI accuracy. We also aim to assess whether this technology     impacts the appropriateness of surveillance intervals.      Design: 1) Before starting the patient enrollment, the participating endoscopists will attend     an internet-based training program on the in vivo differentiation between hyperplastic and     adenomatous polyps. Following this course, a qualifying examination will be required for each     endoscopist to be included.      2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for     inclusion. Patients with at least one histologically verified <10 mm polyp will be included.     In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in     order to rank between a high- and a low- level of diagnostic confidence, and thereafter will     be sent for histological assessment. NBI- and histological accuracy in differentiating     between hyperplastic and adenomatous lesions will be analyzed and compared, in order to     assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI     feasibility and accuracy in the study population, and to assess the variability among the     endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be     achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical     inference on how many patients would be scheduled for an inappropriate post-polypectomy     follow up, when follow up schedule is based on NBI classification. Clinical results will be     analyzed using various statistical measures of significance.      Clinical Site Locations: 10 European centres with NBI-technology      1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site     Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.   "
123021|NCT01675739|"     The purpose of this study is to evaluate the effectiveness of SMS (short message service of     mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.   "
123025|NCT01675687|"     This study is designed to verify that web based follow up intervention after a classic     multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise     self-efficacy, improve drop out rate and advance sustainability after weight loss of obese     women.      Research Questions and Hypotheses        -  How does a web based follow up intervention change self-efficacy of women participating          in an obesity intervention?        -  How does a web based follow up intervention affect the drop out rate of women          participating in an obesity intervention?        -  How does a web based follow up intervention influence sustainability of women          participating in an obesity intervention?   "
123026|NCT01675674|"     This study is being done to learn how many children and young adults who come to pediatric     rheumatology clinics may have mucopolysaccharidosis (MPS). The study tests for 4 of the types     of MPS: I, II, IVA, and VI. This can help researchers decide whether to create a screening     program for MPS at pediatric rheumatology clinics. This study is being done in rheumatology     clinics because the first symptoms of MPS are often joint problems such as stiff joints, and     rheumatologists may be the first doctors that a patient with MPS visits. The study will also     evaluate the utility of dried blood spot testing for MPS.   "
123027|NCT01675661|"     The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200     mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on     cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).   "
123028|NCT01675648|"     In Singapore, opiate substitution medication e.g. methadone is only licensed for use with     specific population. The standard treatment is one week of detoxification assisted with     diazepam and symptomatic treatment followed by one week of rehabilitation. However, diazepam     is highly addictive and widely abused among heroin users and pharmacologically, does not     reduce the physical and psychological craving for opioids which can trigger relapse. Many     opiate patients undergoing inpatient detoxification leave prematurely (i.e. PID: patient     initiated discharge) because of the severity of unpleasant withdrawal symptoms. The purpose     of the study is to establish an alternative medication to reduce opiate withdrawal symptoms     for use in Singapore by evaluating the clinical efficacy of Lofexidine versus Diazepam in the     management of the opiate withdrawal syndrome during inpatient detoxification.   "
123029|NCT01675635|"     The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized     patients with moderate to severe pain following surgery.   "
123030|NCT01675622|"     The efficacy of dose titration of OxyNorm™ immediate-release capsules versus morphine     immediate-release tablets in the treatment of cancer pain.   "
123031|NCT01675609|"     The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate     0.025% ophthalmic solution used four times daily in a population of adult and geriatric     subjects   "
123032|NCT01675596|"     The objective of the study is to observe the safety, efficacy and cost effectiveness of the     Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.   "
123033|NCT01675583|"     The purpose of this study is to investigate the efficacy of an optical device designed and     developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized     that the blood flow velocity of the wound site will provide critical information on the     efficacy of hyperbaric oxygen therapy.   "
123034|NCT01675570|"     The primary purpose of this study is to assess the efficacy, tolerability and safety of     RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.   "
123035|NCT01675557|"     The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses     to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney     Disease subjects requiring chronic hemodialysis.   "
123036|NCT01675544|"     Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between     admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with     acute heart failure can identify patients at risk for recurrent admissions for heart failure.   "
123037|NCT01675531|"     A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin     (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy)     who need opioid combination treatment with existing pregabalin of last dose prior to study     enrollment without changing.      The investigators will assess study objectives as below.      Primary objective        -  To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)      Secondary objectives        -  To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology          Group-Neurotoxicity (FACIT-GOG/NTX)        -  To assess physician's overall satisfaction        -  To assess subject's overall satisfaction        -  To assess safety      The investigators have a hypothesis that Targin will show favorable efficacy & safety profile     for CIPN patients.   "
123038|NCT01675518|"     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics     of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is     administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991     in fasted and fed conditions are compared.   "
123039|NCT01675505|"     The purpose of the study is to investigate whether there are prognostic factors regarding the     mental and functional adjustment of colon cancer patients following curative surgery.     Patients will be selected using specific inclusion criteria. Prognostic factors investigated     include personality characteristics, initial distress, medical, social and economic factors.     The utmost purpose of the study is to assist clinicians with the timely identification of     vulnerable patients in order to ensure their proper management and their optimal adjustment.      Moreover this is the first study using the Distress Thermometer in Greek patients with     cancer.   "
123040|NCT01675492|"     To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and     effective in the treatment of mixed astigmatism.   "
123041|NCT01675479|"     Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe     and effective for the treatment of Hyperopia.   "
123051|NCT01675349|"     The objective of this study is to determine the biologic activity of a Chenopodium album     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house     reference preparation (IHRP).   "
123052|NCT01675336|"     A retrospective case control study to validate the association between Interleukin-1 gene     variations and adult chronic periodontal disease in Chinese (Taiwan).   "
123042|NCT01675466|"     Patients with acute abdominal pain comprise a significant proportion of attendances at     emergency departments. These patients account for about a third of general surgical     admissions in a typical day. In some cases, the diagnosis is clear from baseline     investigations (for example in cases of pancreatitis). In other cases, the diagnosis remains     unclear but there are signs that necessitate urgent surgery (for example in cases of     appendicitis). A final group exists where no clear explanation for the pain is found and     where there are insufficient clinical signs to warrant surgery. These patients are said to     have non specific abdominal pain (NSAP) and present a management dilemma.      Traditionally such patients are managed with a strategy of active observation. Patients are     examined at regular intervals and may undergo imaging. In some cases, symptoms and signs     progress and surgery is needed while in other cases resolution may occur or a diagnosis may     be reached non-operatively allowing focused medical treatment. Recently, two alternative     strategies have emerged. Early cross-sectional imaging using CT scanning may identify     conditions whilst being non-invasive. This would allow diagnosis and treatment would follow.     The alternative strategy of early laparoscopy (key hole surgery) offers the possibility of     concomitant therapy, but is invasive.      The study hypothesis is that in patients with acute non-specific abdominal pain active     management with laparoscopy on admission will reduce hospital stay and costs when compared to     traditional active observation, without increasing complications.   "
123043|NCT01675453|"     The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac     surgery patients. Systemic inflammatory response initiated by CPB through releasing of     several mediators lead to altered endothelial integrity and in consequence the leakage of     proteins and fluids from the intravascular to the interstitial compartment is occurred.     Increased capillary permeability and decreased colloid osmotic pressure were shown to play a     key role for fluid shift and increasing of extravascular water. Further tissue edema can     result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to     adverse outcomes.      Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid     shift from the intracellular and the interstitial spaces of tissue into the intravascular     compartment.      The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6%     hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass     grafting with cardiopulmonary bypass.   "
123044|NCT01675440|"     To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of     symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the     risk of surgical aortic valve replacement has a predicted operative mortality or serious,     irreversible morbidity risk of ≥50% at 30 days.   "
123045|NCT01675427|"     This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes     with disease characteristics and demographics in treatment-naïve and treatment-experienced     chronic hepatitis C patients, including patients with HIV co-infection. There will be a     single study visit for testing.   "
123046|NCT01675414|"     The purpose of this research study is to help us learn if children with Autism Spectrum     Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than     children without ASD do. The investigators hope to learn if children with ASD and     gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and     aggression, more than children with ASD but no GI disorders do. The investigators want to     learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children     with ASD also have gastrointestinal disorders.      Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not     identified by current diagnostic evaluation.      Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an     elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing     children. The investigators anticipate that the proposed study will raise the standard of     medical care for children with ASD by improving current methods of identifying GI dysfunction     and determining whether there is a significant relationship between GI dysfunction and PB in     this population.   "
123047|NCT01675401|"     An increased body mass impairs vascular function (VF), an important characteristic of     subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases.     However, a wide variety of in vivo VF markers exists each measuring different aspects of VF.     Each of these markers addresses a different aspect of the vasculature. Studies comparing     under standardized conditions the differences and relationships of the many different VF     measurements in lean and abdominally overweight / obese subjects are missing. Also, there is     a great need to know which of these markers are sensitive to dietary challenges.      Therefore, it is imperative to conduct an extensive study on dietary effects and     interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and     overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for     cardiovascular disease. The investigators propose to examine, in a two-way     parallel-randomized human intervention study, the effects of weight-loss in abdominally     overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation     and vascular activity during the fasting and both the postprandial and hyperinsulinemic     state. Furthermore, differences - and relations between - VF measurements and plasma     biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese     male subjects.   "
123048|NCT01675388|"     Newborn infants with severe respiratory failure are treated with extracorporeal membrane     oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for     brain injury as a result of hypoxia and blood flow changes in the brain prior to and during     ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO)     and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes,     early diagnosis and intervention for brain injury, decreased cost and duration of clinical     trials, decrease in the burden of chronic neurologic disease and disability in society, thus     improving the health and quality of life of these infants as they progress through childhood     into adulthood.   "
123049|NCT01675375|"     The purpose of this research is to determine if an investigational thin shield can     effectively reduce discomfort following Laser Vision Correction.   "
123050|NCT01675362|"     This study will be conducted to evaluate the protective effects and mechanisms of     antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and     angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.   "
123053|NCT01675323|"     Restless Legs Syndrome (RLS) research has focused on the sensory features and failed to     address an important aspect of RLS; i.e. a 'hyperarousal' or profound chronic sleep loss     without significant excessive daytime sleepiness. This hyperarousal produces RLS symptoms by     overwhelming the normal inhibitory processes needed to decrease sensory and motor cortical     activity for resting and sleep. Thus the hyperarousal produces both the RLS need to move when     trying to rest and the inability to maintain sleep. The biological consequences of this     hyperarousal process on sleep (increased wake time) and cortical excitability (as     demonstrated by transcranial magnetic stimulation (TMS)) are postulated to reflect increased     degree of excitatory glutamatergic activity, and therefore affected brain regions will show     relatively increased glutamate (Glu) and glutamine (Gln) on MR spectroscopy (MRS). Changes in     inhibitory activity and GABA may also occur, but less significantly than the increase in     Glu/Gln. Our pilot MRS data discovered a new abnormality in RLS: increased Thalamic Glx (Glu     + Gln) that correlated well with sleep measures of hyperarousal. Glx levels are not specific     for the neurotransmitter role of Glu.      In this project RLS and matching controls subjects will be studied using polysomnograms (PSG)     and TMS and 7T MRI for MRS that provides accurate measurement of Gln levels, which reflect     mostly neurotransmitter Glu activity. The first aim is to confirm that Gln is increased in     the thalamus and to determine if this also occurs in the motor and sensory cortices. The     relation between Glu, Gln and GABA will also be evaluated. Second, assessments will be made     of the degree of relation between Gln increase and the hyperarousal effects on sleep and     cortical excitability (TMS). This would demonstrate that abnormally increased Glu activity is     primary to RLS hyperarousal and radically changes the emphasis in RLS to be less on dopamine     and more on Glu-hyperarousal as a major feature of RLS.This is an entirely new direction for     RLS research and treatment development. The new concept of hyperarousal adds a missing     dimension to understanding RLS, namely the discovery of the Glu abnormality and its central     relation to the other hyperarousal features.   "
123054|NCT01675310|"     Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that     affect between 1 to 14% of population around the world.      There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican     population.      Metformin has been used during pregnancy in women with gestational diabetes and women with     polycystic ovary syndrome, with acceptable security for mother and fetus.      Metformin decrease the insulin resistance and weight gain, we believe that metformin may be     decrease the risk of gestational diabetes mellitus in high risk women.   "
123055|NCT01675297|"     The purpose of this study is to evaluate the efficacy and the safety of Risedronate,     cholecalciferol combination tablet in patients with Osteoporosis.   "
123056|NCT01675284|"     The focus of this study is to evaluate the safety, reactogenicity and humoral immune     responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg     HA to human subjects.   "
123057|NCT01675271|"     The focus of this study is on individualized exercise prescription on primary prevention of     cardiovascular diseases (CVD). Special attention is set on autonomic nervous system function     and inflammation.      This study will seek novel, cost-effective models of exercise prescription that will     emphasize individuals own response on her health and which would be easily implemented to     primary health care as primary prevention for CVD. According to power calculation,sixty women     planning pregnancy with BMI equal or over 30 and/or history of GDM will be recruited and     randomized to an individual exercise arm (n=20), a general exercise arm (n=20) and a control     arm (n=20). General intervention group will receive general exercise and dietary counselling     whereas a personal exercise and dietary programs will be planned for individualized exercise     group. Those randomized to the control arm will receive no dietary and exercise information.      Clinical exercise tests and autonomic nervous system tests will be performed in the beginning     of the study and after 3 months intervention. Blood samples for markers of inflammation,     glucose homeostasis and lipid status will be collected from prepregnancy period until 1 years     after delivery.   "
123058|NCT01675258|"     Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the     world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are     mostly diagnosed only at later stages of the disease's course through histoimmune staining     and molecular biology processes on the tissues biopsied from the gastrointestinal system     under invasive diagnostic procedures of colonoscopy.      Oral fluid presents a large protein complexity and has been recently used as a diagnostic     biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the     colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to     bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal     cancers. Proteomic technologies provide the tools needed to discover and identify     disease-associated biomarkers.      The aim of the present study is to identify salivary bio-markers in patients suffering from     colorectal cancers.   "
123059|NCT01675245|"     The purpose of this study is to acquire information on the usage, effectiveness, safety, and     levels of health care resource utilization associated with Velcade therapy in recurrent and     refractory multiple myeloma patients who are initiating Velcade and various combination     therapies within the approved indication in a naturalistic setting.   "
123060|NCT01675232|"     The purpose of this study is to investigate the efficacy of two different corticosteroid     ointment application regimens for the treatment of eczema (atopic dermatitis).   "
123061|NCT01675219|"     Bladder cancer (BC), the second most common urological malignancy, is an important public     health issue. One of the main challenges in the treatment of bladder cancer if the prevention     of recurrences of non-invasive tumors, which is also associated with significant costs.      The current study will investigate optimal treatment of patients with bladder cancer with     high risk of tumor recurrence but low risk of progression. The main interest is comparison of     photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy     of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.   "
123062|NCT01675206|"     This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis     patients.   "
123063|NCT01675193|"     The purpose of this study is to determine the optimal screening intervals and     cost-effectiveness of population-based vision screening in preverbal children in the     Netherlands.   "
123064|NCT01675180|"     Purpose/Objective of the study:      The main objective of the study is to investigate oral health awareness and attitudes towards     oral health among Norwegian pregnant women and assess the impact of information about oral     hygiene on the risk of dental caries during pregnancy.      The hypothesis of the study are:        1. The state of oral health during pregnancy depends on pregnant woman's preventive oral          hygiene behaviour and practice.        2. Pregnant women with high level of oral health awareness and positive attitude towards          oral health are more likely to visit their dentists regularly and have better oral          hygiene compared to those with less awareness.        3. Proper information and guidance on oral hygiene care provided during pregnancy can help          to improve oral bacteriological milieu and reduce the dental caries risk among pregnant          women.   "
123066|NCT01675154|"     Funding Source - FDA OOPD      This study is being done to find out whether an investigational (not approved by FDA ) drug     called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in     combination can treat the high blood fat (elevated triglycerides)levels found in the     condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone,     the current standard medical care.      It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in     lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The     researchers are interested in learning whether any one of these drugs when given alone or in     combination is more effective and safe in treating T1HLP.   "
123209|NCT01673269|"     When a doctor performs Endoscopic retrograde cholangiopancreatography ERCP (Endoscopy to     examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The     tube passes beyond the stomach and into an opening in the liver called the bile duct. Another     small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile     duct to ensure that there are no cancers or stones in the bile duct and occasionally to take     a sample from the bile duct. The purpose of our study is to examine wither performing this     procedure can transmit bacteria from the bile duct to the main blood stream.   "
123067|NCT01675141|"     Background:        -  Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed          at controlling symptoms and reducing the number of myeloma cells. It continues until the          cancer stops responding to treatment. At that time, treatment may switch to maintenance          therapy, which is given to try to extend the response of the first therapy for as long          as possible. Research suggests that lenalidomide maintenance therapy may delay the time          for myeloma cells to start to grow and possibly improve survival.        -  Lenalidomide is a drug that may reduce or prevent the growth of cancer cells.          Researchers want to look at the long-term effect of lenalidomide on immune cells. It          will also look at the effects of extended treatment on the cancer and the immune system.      Objectives:      - To test the long-term effectiveness of lenalidomide therapy for multiple myeloma.      Eligibility:      - Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          sample will be collected. A bone scan and bone marrow biopsy will also be performed.        -  Participants will receive lenalidomide maintenance treatment. It will be given according          to the standard of care for multiple myeloma. Participants will take lenalidomide every          day for 21 days of repeated 28-day cycles.        -  Treatment will be monitored with frequent blood tests. Blood tests will look at the          effect of the treatment on the immune system.        -  Treatment will continue as long as the cancer does not worsen and the side effects are          not severe.   "
123068|NCT01675128|"     Background:      - Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the     deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other     chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They     want to see if the drugs are a safe and effective treatment for advanced solid tumors or     colorectal cancer that has not responded to other treatments.      Objectives:      - To test the safety and effectiveness of ISIS 183750 with irinotecan for advanced solid     tumors or colorectal cancer.      Eligibility:      - Individuals at least 18 years of age who have solid tumors or colorectal cancer that has     not responded to other treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will also be collected. Tumor tissue samples may be collected as well before and          after treatment. Imaging studies will also be performed.        -  Participants will take ISIS 183750 once a week for 28-day cycles of treatment. On the          first cycle, they will also have ISIS 183750 on days 3 and 5.        -  Participants will take irinotecan every second week, beginning on day 15 of the first          cycle.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Treatment will continue as long as the cancer does not grow and the side effects are not          severe.   "
123069|NCT01675115|"     The objective of this study is to investigate the efficacy and safety of BNG-1 in patients     with ischemic stroke. The efficacy assessment will be based on the functional outcome while     the safety will be reviewed by the adverse events and laboratory examinations.   "
123070|NCT01675102|"     17p-/p53-mutated chronic lymphocytic leukemia (CLL) is an orphan disease, accounting for     approximately 5% of newly diagnosed CLL. This subgroup of patients has a very poor outcome     after chemoimmunotherapy. Allogeneic HCT may change the poor prognosis. In a retrospective     EBMT-analysis on 44 patients with advanced 17p-CLL 2-year progression-free survival was 45%     (95% CI, 30% to 60%) after allogeneic HCT (Allogeneic hematopoietic stem-cell transplantation     for chronic lymphocytic leukemia with 17p deletion: a retrospective European Group for Blood     and Marrow Transplantation analysis. J Clin Oncol, 2008, 26, 5094-5100).      Referring to these favorable results and small additional series, patients with 17p-CLL     requiring therapy are considered to have an indication for allogeneic transplantation by many     CLL study groups. Several CLL study groups recommend allogeneic HCT in 17p-CLL as part of the     first- or second line treatment.      The aim is to collect additional evidence on allogeneic HCT in 17p-/p53-mutated CLL in first     or second remission by a non-interventional prospective study. Patients shall be registered     prior to HCT at the Leiden Office in order to rule out a reporting bias after     transplantation.   "
123071|NCT01675089|"     The purpose of this study is to determine whether zolendronic acid, a third generation     bisphosphonate, is effective in preventing bone loss in the first year after kidney     transplantation.   "
123072|NCT01675076|"     The purpose of this study is to determine the best strategy to manage novel oral     anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators     hypothesize that performing device surgery without interruption of the novel oral     anti-coagulant will result in a reduced rate of clinically significant hematoma.   "
123073|NCT01675063|"     The overall goal of this collaborative study is to advance the novel pulse contour analysis     to the point at which it can be incorporated into a real-time device. The specific objective     is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in     units of liters-per-minute. To achieve this objective, the waveforms for analysis and     reference pulmonary artery catheter CO measurements will be recorded from critically ill     patients and then analyzed off-line at Retia Medical. Successful completion of this study may     ultimately help lead to improved outcomes of critically ill patients.   "
123335|NCT01671631|"     The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration     is currently required for functional evaluation of stenosis severity using the fractional     flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the     instantaneous wave-free ratio (iFR), was recently introduced.      Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free     pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow     reserve (FFR) in ACS patients.   "
123210|NCT01673256|"     The objective of this study is to assess the atrial fibrillation (AF) episode detection when     using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).   "
123231|NCT01672983|"     This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of     ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as     ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b)     or genotype 2 (HCV GT2) infection who were previous treated with pegylated     interferon/ribavirin (pegIFN/RBV).   "
123074|NCT01675050|"     The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover     trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in     children, achieving a greater response than that observed with placebo. In addition to     assessing self-report of pain and other symptoms, the investigators also propose to perform     experimental somatic pain testing to determine if there is evidence of     peripherally-maintained central sensitization in children with FAP. The investigators also     hypothesize that there will be an increase in somatic pain threshold after completion of a     Cyproheptadine course compared to baseline testing prior to treatment, and compared to     placebo. This would allow children with FAP to return to normal function, improve symptoms     and overall general well-being   "
123075|NCT01675037|"     Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment     of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor     which is part of the hypothalamic-pituitary neuronal network is the key of this surgical     procedure.      Purpose: There are no prospective data available about the endocrine effects after ETV in     children and adults. The principal aim of this prospective study is to evaluate the     variability of hypothalamic-pituitary hormones and clinical effects in children and adults     after ETV in order to plan a multicentric study.   "
123076|NCT01675024|"     This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine     after single and multiple doses of Rotigotine transdermal patch, and also to investigate the     safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.   "
123077|NCT01675011|"     This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years     with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six     (36) months following uterine fibroid embolization.   "
123078|NCT01674998|"     The purpose of this research study is to determine if safe, simple and non-invasive tests     such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify     neurological disorders before typical symptoms occur. Researchers believe that early     identification of these disorders could lead to treatments to prevent, delay, or slow the     development of one of more of these diseases. Some people with REM sleep behavior disorder     (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but     many do not.   "
123079|NCT01674985|"     The purpose of this study is to investigate whether infusion of G-CSF mobilized     HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine     chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.   "
123080|NCT01674972|"     The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1     receptor agonists are used for the treatment of T2DM. Insulin resistance is a     pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect     in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1     secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared     to healthy controls. The results of this study will expand the knowledge of the     pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.   "
123081|NCT01674959|"     Radiation therapy plus concurrent chemotherapy has been demonstrated a significant     improvement in overall and disease-free survival according to Intergroup Trial 0116 in     patients with gastric cancer after surgical complete resection. Advantage of application of     IMRT has been shown in planning comparison studies for postoperative gastric patients. So the     investigators designed the trial to see safety and efficacy of postoperative concurrent     chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.   "
123082|NCT01674946|"     The purpose of this study is do determine the functional significance of the G     protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural bile     acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.   "
123083|NCT01674933|"     The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any     further dental decay among 3-4 year old children in nursery schools.      It is important to ascertain the additional preventive value that fluoride varnish may     provide when applied in conjunction with other preventive measures which form part of a     national dental health improvement programme targeting children at risk from dental decay.     1600 children will be recruited into the study for 2 years.   "
123084|NCT01674920|"     CHOICES is a program to provide children and families with lifetime tools and lifestyle     strategies to achieve and maintain a healthy body size. Both parents and children get active,     learn about the food choices they can make, and about the roles of TV in their lives. Led by     physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences     that connect into the participants' daily lives. In the study, the families were divided into     two groups, beginning their classes 6 months apart. Body measurements were taken at baseline     and every 4 months to 16 months.   "
123085|NCT01674907|"     This observational study will evaluate the use in clinical practice and the efficacy of     Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received     prior chemotherapy treatment in the metastatic setting. Patients for whom the treating     physician has decided to initiate therapy with Avastin will be followed for 10 months.   "
123086|NCT01674894|"     This post-marketing, single-center prospective study will be conducted in an open-label,     non-interventional setting, for women seeking fertility treatment and will describe cleavage     dynamics in relation to the age of the oocyte and gonadotrophin treatment.   "
123096|NCT01674764|"     Despite many years of research, an incomprehensible amount of scientific efforts worldwide     and billions of dollars invested, no effective therapy resulting in major neurological or     functional recovery is available to date for traumatic spinal cord injury (tSCI). Although     there is increasing experimental evidence from animal models that surgical decompression of     the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data     yet. The main explanations for this lack of convincing evidence are relatively small sample     sizes in previous studies, their predominantly retrospective nature, suboptimal measurement     methods for the assessment of neurological deficits, and inappropriate recording and     documentation of potential confounding factors.   "
135544|NCT01510639|"     The purpose of this study is to test the hypothesis that the application of PRP leads to     faster wound healing, less wound healing disorders, less pain and faster functional recovery     after subacromial surgery.   "
123087|NCT01674881|"     A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for     breast cancer experience negative sequelae in the form of pain following treatment. Chronic     pain is known to be associated with impaired social and emotional functioning, and thus     presents a particular concern.      Mindfulness-based intervention is among the complementary, psychological treatments, which     cancer patients commonly seek out in relation to the course of their illness. Despite the     popularity of mindfulness-based intervention among cancer patients, no studies have so far     investigated the effect of mindfulness-based intervention on chronic pain in breast cancer     patients. While no studies so far have focused on pain, there is evidence to suggest that     mindfulness-based intervention is associated with improved psychosocial adaption to cancer.     Furthermore, non-cancer research suggests that mindfulness-based intervention is associated     with reduced pain experiences.      The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy     (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment     for breast cancer and who experience chronic pain, will be randomized to an intervention     group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the     same time points, i.e. before the intervention (baseline), and three times after the     intervention/control condition, with the last follow-up 6 months after the intervention. In     addition, a number of potential moderators and mediators of the outcome will be explored. For     example, recent studies indicate that adult attachment style may constitute an important     moderator and/or mediator in the development of pain, and preliminary research has suggested     that attachment style may moderate the effect of mindfulness-based intervention.      The results will provide valuable new knowledge about the potential of MBCT as a treatment     strategy for chronic pain in breast cancer patients, will contribute to the clarification of     underlying mechanisms in the experience of and coping with pain, which could help the     development of more effective, individualized interventions.   "
123088|NCT01674868|"     This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME     study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the     effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American     sample of post-acute stroke patients. This trial will in addition examine the effect of     treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial     attention, as well as post-stroke fatigue and will evaluate the durability of observed     effects. The results of this pilot trial will be used to develop power estimates for a larger     trial and to evaluate recruitment and intervention completion rates for subjects in an     American post-acute environment. There are two additional substudies: the first will use MRI     to assess structural changes at the beginning and end of the intervention; the second will     examine the relationship of serum biomarkers of inflammation to the intervention.   "
123089|NCT01674855|"     This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily     G-CSF in chemotherapy-induced neutropenia.   "
123090|NCT01674842|"     This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients     with ER negative, PR negative and HER2 negative breast cancer who have undergone     breast-conserving surgery or mastectomy.      Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of     cisplatin when given concurrently with radiation therapy for participants with Stage II or     III breast cancer who have undergone breast conserving surgery or mastectomy   "
123091|NCT01674829|"     To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with     advanced dry AMD To evaluate the safety of the surgical procedures when used to implant     MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To     evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of     MA09-hRPE cellular therapy.   "
123092|NCT01674816|"     Problem:      Currently, no system allows precise kinematic assessment of the knee and accurate guiding of     orthopedic surgical actions in a minimally invasive fashion. However, such a system would     prove useful in the clinical setting to improve the quality of surgical interventions at the     knee.      Hypothesis:      A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging     and minimally invasive bony fixation allows precise kinematic assessment and surgical     guidance in the routine clinical setting.      Objectives :        -  Demonstrating the capacity of the system to precisely measure 3D knee kinematics        -  Quantifying the reproducibility of the kinematic measurements        -  Measuring the impact of knee surgical procedures on knee kinematics        -  Assessing the correlations between measured articular kinematics and clinical results          after knee surgery        -  Integrating the novel measuring system to the surgical flow of three knee surgical          procedures        -  Quantifying the precision and reproducibility of the surgical actions guided by the          system        -  Comparing the clinical results of surgeries guided by the system to those performed with          the traditional technique   "
123093|NCT01674803|"     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has     led to a significant reduction in morbidity. However, the first generation of these devices     had no positive impact on the mortality after PCI (compared to bare metal stents), which was     greatly attributed to a somewhat increased incidence of late and very late stent thrombosis.     Concerns about the role of durable polymers as a potential trigger of inflammation and     finally adverse events also led to the development of DES with biodegradable coatings, which     leave after degradation of the coating only a bare metal stent in the vessel wall that does     not induce an inflammatory response. While such biodegradable polymer DES are increasingly     used in clinical practice, there is no data available from head-to-head comparisons between     biodegradable and contemporary third generation durable polymer DES.   "
123094|NCT01674790|"     The objective of the 'Exploring potential synergistic effects of aerobic exercise and     cognitive training on cognition after stroke' pilot trial is to investigate the combined     effects of aerobic and cognitive training on cognition after stroke. This is to lay the     groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months     post-stroke will be randomly assigned into one of four following treatment groups: (i)     aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic     exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of     motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions, please     see detailed description below). We hypothesize that the combination of aerobic exercise and     cognitive training will be more effective in improving cognition after stroke than either     treatment on its own.   "
123095|NCT01674777|"     This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics     and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male     subjects.   "
123185|NCT01673594|"     The purpose of this study is to a) assess the efficacy of naltrexone in preventing     stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere     with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether     naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We     predict that naltrexone will successfully prevent stimulant-induced euphoria without     interfering with the ability of stimulants to effectively treat ADHD in adults. This study     will be an 8 -week trial with young adults (18-24) with ADHD.   "
123097|NCT01674751|"     This pilot study will test the feasibility and potential effectiveness of a novel approach to     improve food choices by employees about what to eat for lunch. The intervention involves the     testing of an on-line pre-ordering food program with nutritional information linked to a     hospital cafeteria. In this study, the investigators use positive reinforcement of feedback     and price discounts during the intervention phase, and then withdraw those components in     order to assess the potential for changes to be retained after the study is over.      The study draws on principles from the field of behavioral economics and behavioral change.     The investigators test the effectiveness of the intervention with 30 employees (study     participants) who are overweight or obese. Based on a recent screening of over 5600 Einstein     employees, 66% of those screened were identified as either overweight or obese. There are 3     phases to the trial: baseline (P1), 4 week intervention, (P2) and tapering (intervention     without reinforcement) (P3). Participants are randomized to one of two groups (intervention     and wait-listed controls).      Our primary hypotheses are that:        1. Participants will purchase lunches with fewer calories during the intervention compared          to baseline.        2. Participants will purchases lunches with fewer calories in the tapering phase compared          to baseline.      Secondary hypotheses include that, compared with baseline, participants will order lunches     with less fat. Changes in participant weight based on self selected goals, and in a measure     of mindful eating will also be investigated. The investigators expect that participant     adherence will be associated with improved outcomes compared to those who are less adherent.   "
123098|NCT01674738|"     This study wants to determine the activity of a first-line treatment related to Thymidylate     Synthetase (TS) Expression. Patients with the diagnosis of non-squamous advanced     Non-Small-Cell Lung-Cancer (Stage IV) and without evidence of EGFR mutation may be enclosed     in this clinical trial.   "
123099|NCT01674725|"     The purpose of this study is to evaluate the safety and antiviral activity of     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin     (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without     cirrhosis.   "
123100|NCT01674712|"     This is a double-blind, randomized study designed to compare the efficacy and safety of two     fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin     145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the     blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat     in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has     been marketed in more than 80 countries since 1975. Simvastatin is also used for the     treatment of patients with a high level of cholesterol. These have also been marketed     worldwide for more than 20 years. It is important to treat high levels of fats in the blood     because it has been shown that even mildly elevated level of lipids in the blood can lead to     diseases of the blood vessels. It has been shown in several studies and in clinical practice     that the combination of fenofibrate plus simvastatin can lead to improved effects on blood     fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the     study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin     145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing     high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in     reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.   "
123101|NCT01674699|"     The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether     safety and outcomes of the device use in the commercial setting are comparable to the safety     and outcomes of the device use in the IDE study.   "
123102|NCT01674686|"     The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin     receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients     with variant angina.   "
123103|NCT01674673|"     It is known that the treatment of panic disorder with medication and psychotherapy are both     effective. Representative as a treatment for panic disorder, Selective serotonin reuptake     inhibitors (SSRIs) are recommended as first-line treatment of panic disorder. In general, the     initial reaction rate of panic disorder medication known to be frequently stopped early     recurrence 70-80% It's too early, it is recommended that the duration of drug treatment for     at least one year to be long-lasting. But whether it is appropriate for the duration of drug     treatment to maintain a certain extent remains controversial, and maintain the medication for     more than one year, even if the long-term effects known to be approximately 50% less than     beyond being negative when remission based. Meanwhile, the typical method for the treatment     of panic disorder psychology, cognitive behavioral therapy (Cognitive behavioral therapy) and     looked comparable to the effect of the drug in the treatment of the known, especially in     recent years when the combined treatment with medication can increase the long-term treatment     of sexual reported that there's has been the subject of attention.      But prospectively compare the long-term effects of these two treatments, research, especially     the research about the long-term effects of the combined treatment with the drug treatment of     panic disorder is very low, and almost nil is Researchers, drug treatment and the effect of     the combined treatment in patients with panic disorder over two years prospective study to     compare the plans were. And verification, the researchers performed only through this study     by comparing the long-term effects of the combined treatment with medication combined     treatment of medication to be more effective than if the reaction to the long-term treatment     of panic disorder that can affect the clinical and biological factors navigate to evaluate     them. In addition, long-term observational study, panic disorder patients' subjective quality     of life actually improved to some extent on the map together proven to.   "
123104|NCT01674660|"     The purpose of this study is to explore the factors associated with interdialytic blood     pressure variability in maintenance hemodialysis patients, especially the association between     volume status and blood pressure variability.   "
123105|NCT01674647|"     A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo     cardioversion (procedure to restore normal heart rhythm). The study will compare patients     assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA).     The study will measure common medical outcomes for this type of patient such as bleeding and     stroke.   "
123106|NCT01674634|"     The primary objective of this study is to assess the safety of two concurrent injections of     AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable     cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of     occurrence of targeted serious adverse events (tendon rupture/ligament injury and     anaphylaxis) to historical rates of the same in clinical studies and post-marketing     commercial use.      The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.   "
123107|NCT01674621|"     To determine the clinical safety and efficacy of BA058 Transdermal in otherwise healthy     postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD)     and serum markers of bone metabolism when compared to Transdermal Placebo and BA058 Injection     for 6 months of treatment.   "
123108|NCT01674608|"     Patients in the Intensive Care Unit (ICU) traditionally receive bed rest as part of their     care. They develop muscle weakness even after only a few days of mechanical ventilation that     may prolong their time in ICU and in hospital, but the nature of such weakness is poorly     understood.      The weakness that develops in ICU is more substantial than that which would result from bed     rest alone and is referred to as ICU acquired weakness (ICUAW). This weakness might be due to     the combination of inflammation and immobility. The exact mechanisms leading to the nerve and     muscle damage which occurs in critical illness are not yet fully understood and require     further investigation. However, it is known that ICUAW has an effect on a patient's ability     to breathe without a ventilator, walk and perform simple activities (like washing and     toileting) and often results in longer mechanical ventilation time and hence, longer hospital     stays than might otherwise be expected. It may also affect a patient's ability to return home     after their hospital stay. The recovery period in Australian and New Zealand ICU patients is     unknown but a trial from Canada has reported ongoing weakness five years after leaving ICU.     Weakness in survivors of intensive care is known to be a substantial problem. It is currently     not known whether ICUAW may be avoided or its severity reduced with simple strategies of     early exercise in ICU.      There are no data about the level of activity and mobility in critically ill patients in     Australian and New Zealand ICUs. These data are urgently required to plan a program of     research to test whether increasing the level of mobility and activity in our critically ill     patients is safe, feasible and efficacious in terms of reducing the severity of ICUAW and     improving patient-centred outcomes. The program of research will first include a study to     observe the mobility levels in 25 ICUs across Australia and New Zealand to determine safety,     barriers to mobility and what type of activities are undertaken by our patients.      From the observational data we plan to develop a pilot randomised controlled trial of early     mobility and activity in intensive care units across Australia and New Zealand. This simple,     cost-effective strategy may improve functional ability, decrease time on mechanical     ventilation and improve long term outcomes in this patient group. By initiating such a     program, ANZ investigators might be able to change future patient outcomes worldwide.   "
123109|NCT01674595|"     This trial is an open, national, multi-centre trial. The trial will be initiated after olive     pollen season 2012 and subjects will receive treatment for 6 weeks.      The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The     frequency of patients with adverse reactions will be the primary endpoint.      Frequency of patients with systemic reactions according to EAACI classification, increase in     IgG4 and in IgE and reduction in immediate skin reactivity.   "
123110|NCT01674582|"     The main purposes with this trial is to investigate the potential of MRI with diffusion and     blood volume, flow in brain to diagnose and to measure treatment effects in patients with     intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate     the possibilities to individually adjusted treatment in this category of patients depending     on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI     to evaluate a correlation and to perform testing of cognitive ability before, during, and     after treatment and to investigate if given treatment causes any decrease in the patients     habitual state.   "
123111|NCT01674569|"     The objective of this study is to evaluate the safety and preliminary biologic     activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD).     Preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein     leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus     photography, fluorescein angiography and optical coherence tomography (OCT).   "
123112|NCT01674556|"     The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable     tumours      The specific sub-objectives of the studies are:        -  To quantify tumour sizes and relate it to the patient survival over time, dependent of          treatment method.        -  To evaluate and compare the toxic effects and safety of gemcitabine in combination with          US contrast agent under sonication with gemcitabine alone.        -  Develop and validate new ultrasound perfusion algorithms based on burst- replenishment          for diagnosis and monitoring of therapy.        -  To quantify gemcitabine and its main metabolites in plasma and in circulating          mononuclear cells before, during and after pancreatic sonication, and to quantify the          concentration of intracellular endogenous nucleotides in circulating mononuclear cells          at the same time points.        -  To assess plasma and tissue concentrations of gemcitabine, its main metabolites and          endogenous nucleotides in those patients where surgical resection can be performed on          standard clinical indications.   "
123113|NCT01674543|"     Schizophrenia is a severe mental illness, of psychosis being the most prevalent in society,     affecting 1% of the population. The treatment of schizophrenia is basically done with     antipsychotic drugs, although other non-pharmacological interventions, such as exercise, a     form of treatment seems to be considered. Among the most recommended exercise for the general     population, the investigators highlight the aerobic and resistance exercises. However, few     studies have reported the positive effect of aerobic exercise in the pathogenesis of     schizophrenia. In relation to resistance exercise and concurrent training, it is unknown if     the effect in patients with the disease, especially when one considers the junction of the     two types of exercises in the same training session (called concurrent training). However, it     is known, through clinical studies and animal models, that exercise modifies the brain     improves neuroplasticity, the mental condition of the individual frames and reverses     neurodegeneration. Associated with improvement in schizophrenia, few clinical trials of     aerobic exercise showed improvement in disease symptoms, reducing anxiety and depression, and     clinical global improvement. The hypothesis is that the types of proposed training,     resistance training and concurrent training can improve clinical symptoms of the disease, and     improve the side effects caused by drugs. It is believed that the clinical changes are     accompanied by increased serum IGF-1 by resistance training and aerobic training by BDNF.   "
123114|NCT01674530|"     The objective of this study is to evaluate the clinical equivalence and safety of the test     formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd     compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo     Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation   "
123115|NCT01674517|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
123116|NCT01674504|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
123117|NCT01674491|"     Black soy peptides have been shown to possess properties that may decrease blood pressure. To     examine the effects of black soy peptides supplementation on blood pressure and oxidative     stress in subjects with pre-hypertension or stage I hypertension.   "
123186|NCT01673581|"     This study will evaluate the usefulness of an informational website designed to educate     patients with prostate cancer about their options for treatment. The investigators hope that     this website will assist patients with making informed decisions about their care and     improving their satisfaction with the treatments they choose.   "
123118|NCT01674478|"     Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common     devastating gastrointestinal diseases in premature infants. These infants often need surgical     intervention to remove the dead bowel and create temporary enterostomies, resulting in short     bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction     to digest and absorb nutrients adequately.      These infants are often nourished primarily with parental nutrition (PN) which can lead to     many complications including PN-associated liver disease. However, with enteral feeding, the     remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral     fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty     acids (LCPUFA) being the most beneficial in promoting bowel adaptation.      Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation.     Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and     increase weight gain in some SBS infants. WThe investigators will soon have completed a     randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled Early     Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with     Enterostomies. The preliminary data suggest that (a) by supplementing enteral ML/FO, we were     able to decrease the use of IL; (b) premature infants in the treatment group who received     ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and     better weight gain (g/day) after reanastomosis than those who received routine care in     control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in     the treatment group than the control group although the difference was not statistically     significant. Because the intervention consisted of both an increase in enteral fat intake as     well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in     the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat     intake. Therefore, the investigators have designed a next randomized clinical trial to     compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO     will result in decreased systemic inflammation, as indicated by blood levels of     inflammation-related proteins and indicators of oxidative stress.   "
123119|NCT01674465|"     Calcineurin Inhibitors (CNI) are drugs used to suppress the immune system when a person has a     solid organ transplant. Although these drugs keep the transplanted organ from being rejected     they are toxic to kidneys, or nephrotoxic. CNIs cause damage, called fibrosis, to kidneys.      Fibrosis is a type of scarring that occurs in kidney tissue. Fibrosis can eventually lead to     kidney failure. One of the pathways that cause fibrosis is a chronic lack of oxygen to the     kidney tissue called hypoxia. There is a protein called Nox2 that may be involved in how     this hypoxia happens in the kidney. The Department of Medicine-Nephrology at the University     of Wisconsin is conducting a research study to see how much of the Nox2 protein is present in     kidneys that may have fibrosis caused by CNIs and whether a certain type of Magnetic     Resonance Imaging (MRI) can be used to tell in advance if the disease caused by CNIs is     getting worse. Study hypothesis: MRI, a non-invasive technique, can be used to determine     whether CNI induced kidney disease is getting worse. Additionally, the study aims to     determine the role of Nox2 in CNI nephrotoxicity.   "
123120|NCT01674452|"     The aim of this study is the development and the implementation of a new protocol about     home-based exercises, supported by an illustrated manual, for the treatment of individuals     with stroke.      The hypothesis is that this group of patients who are going to carry out the training of this     study protocol are going to show improvement in measured parameters (functionality and     physical performance), which allows this protocol to be improved and published as a proposal     of physiotherapeutic treatment.   "
123121|NCT01674439|"     Although first reports of the clinical use of adipose-derived regenerative cells (ADRC)     suggest that this approach may be feasible and effective for soft tissue augmentation, there     is a lack of randomized, controlled clinical trials in the literature. Hence, this study     aimed to investigate whether a novel protocol for isolation of ADRC and their use in     combination with fat tissue improve the long-term retention of the grafts in patients with     craniofacial microsomia.   "
123122|NCT01674426|"     This is a randomized pilot study of the use of cognitive behavior therapy versus observation     to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.   "
123123|NCT01674413|"     This is a study that invites adults with Crohn's disease and have been responding well to     Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance     medications in Crohn's disease, particularly when in remission. Patients want to know that     they truly need to take a medication, yet they don't want to have flares. The purpose of this     study is to see that if we monitor the patient, along with looking at changes in their stool     samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks, or add     as-needed dosing only, and keep them in remission.   "
123124|NCT01674387|"     Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy     on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical     basis for the chronic neck pain treatment and evaluation of efficacy.   "
123125|NCT01674374|"     The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium     myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on     the management of mucositis (inflammation and ulceration that occurs in the mouth) brought on     by chemotherapy and radiation therapy for squamous cell carcinoma of the head and neck   "
123126|NCT01674361|"     This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will     evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with     obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin     30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their     background therapy with an SSRI. Participants will be allocated to one of two strata.     Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will     receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2     visit. Participants in both strata will receive the study drug in addition to their     background therapy with an SSRI until Week 16.   "
123127|NCT01674348|"     It is a phase II, randomized, double-blind, placebo-controlled study of P2202 in patients of     type 2 diabetes mellitus, inadequately controlled with a stable dose of metformin or     sulfonylurea or both.   "
123200|NCT01673386|"     This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride     and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for     Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0     vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2     treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in     between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and     sunitinib sequentially. The study is designed to compare subject treatment preference, as     well as overall safety and tolerability, frequency of dose modifications and kidney-specific     health outcomes/QoL.   "
123128|NCT01674335|"     Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people     with pain try to continue their daily activities at the same level as they were able to     manage before they had pain. This way of coping causes increases in their pain; they become     discouraged and give up on their activities. AP treatments involve helping them regulate     their activity level so that they can achieve important life goals. Although AP is widely     used, its effectiveness is still unproven. There are two key approaches: The operant learning     (OL) approach uses quotas related to time or goals the person sets. The energy conservation     (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have     often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We     will examine the effects of these treatments on pain, fatigue, quality of life, physical     functioning and mental well-being. We will also investigate whether other factors influence     treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS     patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be     collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS     patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care     London. OL and EC treatment manuals will be developed by experts in the field and both     interventions will be given by two occupational therapists over a 3 month period as     stand-alone interventions (10 sessions of 120 min). All sessions will be recorded in order     to assess intervention fidelity. This study will be the first to base AP interventions on a     clearly delineated theoretical framework. It will clarify whether AP strategies benefit     individuals with FMS and whether either of these two approaches is more effective. Our     results will help to direct clinical resources and funding toward the most beneficial     interventions.   "
123129|NCT01674322|"     The purpose of this study is to investigate the absorption, the metabolic pathways and the     excretion of ibrutinib in healthy male adult participants after administration of a single     oral dose of 50 mg to 140 mg (5 mg/mL solution) of unlabeled ibrutinib admixed with 14C     ibrutinib.   "
123130|NCT01674309|"     The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer,     with an objective response rate of about 70 %. This phase II is to investigate if this     systematic attack chemotherapy could control at the same time the rectal tumor and the     synchronous metastasis without compromising secondarily the tumor or the metastasis resection     or a radiochemotherapy administration.        1. The main objective of the trial is to investigate the tumoral control rate at 4 months,          according to the RECIST criteria (version 1.1).        2. The secondary objectives are:             -  safety of the treament,             -  rate of local failure and local complication (occlusion, important bleedings,               resistant pains with morphinic treatment, perforation),             -  survival without local failure (radiological or clinical progression of the rectal               cancer or local complication),             -  rectal tumor response rate (CT scan, MRI and endocopy),             -  metastasis response rate,             -  disease free survival after complete resection (of primitive tumor and metastases),             -  progression free survival (local or distal),             -  overall survival, quality of life (QLQ-C30 + CR 29).   "
123131|NCT01674296|"     The purpose of this study is to develop a better understanding of factors affecting     American's energy balance related behaviors - in this case, food intake and activity. In the     present study we will describe the relative contributions of individual psychology and     physiology (including metabolism, mood, and sleep habits) and external (season, stressors)     contributions to changes in adiposity over a year in free-living individuals.      This study will illuminate season's role in changes in energy balance related behaviors and     body weight and composition. Ultimately, this information will be used to identify factors     affecting food consumption and individual activity during seasonal periods to help to segment     interventions for obesity prevention in mid-life women.   "
123132|NCT01674283|"     The success of in vitro fertilization is based mainly on uterine implantation embryo. An     excessive uterine contractility may interfere with implantation by a movement of the embryo     in the uterus. The inhibition of the uterine contractility may have a positive effect on     success rate of in vitro fertilization. It is through parenteral injection of glucagon and     its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the     time of embryo transfer, the investigators intend to improve the pregnancy rates obtained     after IVF.   "
123133|NCT01674270|"     To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on     intratumoral levels of androgens.   "
123134|NCT01674257|"     Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks     and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing     atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with     hardening of the neck arteries due to undergo surgery to remove the hardened areas. The     investigators will then be able to compare the hot spots found on these scans with what the     investigators can see in the removed specimens under the microscope in the laboratory. This     will give investigators insight into the value of PET CT and MRI as tools for assessing     atherosclerosis. It will also provide the investigators with new information relating to the     underlying processes that give rise to atherosclerosis and will pave the way for the future     development of new treatments.   "
123135|NCT01674244|"     Despite the considerable efforts of the DoD and VA to improve awareness of mental health     problems and access to care, many returning veterans still report substantial barriers to     seeking traditional mental health care. Research suggests that a significant barrier to     pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of     this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the     utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise     and mindful breath training) in addressing global post-traumatic stress disorder (PTSD)     symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD.     Specifically, this study will examine whether a 12-week course of Integrative Exercise     therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD     symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves     other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological     distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist     condition) and 3) whether such treatment is feasible and acceptable.      A secondary aim of this study is to evaluate possible mechanisms underlying these effects     such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic     capacity, and improved sleep.   "
123201|NCT01673373|"     The purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed     with atherosclerotic renal artery stenosis and whether or not increased blood flow by the     stent will help to control blood pressure.   "
123202|NCT01673360|"     To monitor post-market performance through evaluation of short and long-term performance via:        -  Efficacy        -  Safety        -  Patient reported outcomes   "
123136|NCT01674231|"     The investigators hope to learn about the effects of whole grapes, in the form of     freeze-dried grape powder, on markers of health. Phytochemical rich food consumption is     associated with protection against chronic diseases such as cardiovascular disease (CVD)     demonstrating the ability to modify endothelial function and lipemia, but exact causal     mechanisms are still not well understood. The investigators will examine metabolic and     mechanistic effects of consumption of whole grape powder in chronic as well as acute settings     in response to meal challenges by testing blood samples to determine if markers of health     have improved.      The central hypothesis of this project is that consumption of grapes in the form of a     polyphenol-rich freeze-dried whole grape powder (WGP) will attenuate chronic and meal induced     oxidative stress and inflammatory responses in obese individuals.   "
123137|NCT01674218|"     This is a Phase I, single-center, double-blinded, randomized, placebo-controlled, five-period     cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of PA-824 plus     moxifloxacin on cardiac repolarization (QT/QTc interval duration) in a total of 75 healthy     male and female participants, aged 18 to 45 years. Moxifloxacin will be used as an active     control. Participants will be blinded to the treatments they will receive. The study consists     of a screening period up to 26 days; enrollment, 1 day; five in-patient treatment periods     consisting of an admission day (except in the first treatment period, when the pre-dose day     is the baseline), dosing day and two post-dosing days; an out-patient period of at least     three days and not more than 10 days between treatment periods; and a final visit 7 - 14 days     after discharge from the last treatment period.   "
123138|NCT01674205|"     This study seeks to understand the host factors that affect the replication and immune     response of seasonal and candidate pandemic live attenuated influenza vaccine (LAIV) in     humans and to develop biomarkers that can predict the viral shedding and immune response to     LAIVs.   "
123139|NCT01674192|"     The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of     prucalopride in subjects with various degrees of renal impairment compared with normal renal     function and to monitor the safety profile of prucalopride in subjects with renal impairment.      Hypothesis:      Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally     impaired subjects compared with the normal population.   "
123140|NCT01674179|"     The purpose of this study is to retrospectively analyze Clinical and Nocturnal     Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.      Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent     awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during     routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha     intrusions may be an objective marker for Fibromyalgia and may correlate with current     clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.   "
123141|NCT01674166|"     The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03     mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal     retention.      Hypothesis:      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the     adult pharmacokinetic profile   "
123142|NCT01674153|"     Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims     of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of     dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it     is suggested that exercise increases the cardiac output, thus increases the blood flow to     lower extremities. This leads to increased toxin removal from low blood flow regions. On the     other hand, exercise can possibly dilate the vasculature and decrease the compartmental     resistance. In this study, the investigators aim to investigate the exercise induced     physiological changes which enhances the toxin removal. This information combined with     patient specific mathematical models will encourage clinicians to opt for Optimal     intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted     renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin     removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional     hemodialysis.   "
123143|NCT01674140|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or     exemestane, may fight breast cancer by lowering the amount of estrogen the body makes.     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. It is not yet know whether hormone therapy is more effective when given with or     without everolimus in treating breast cancer.      PURPOSE: This randomized phase III trial studies how well giving hormone therapy together     with or without everolimus work in treating patients with breast cancer.   "
123144|NCT01674127|"     The present study examined the effects of Methyldopa on uterine artery diameter, uterine     artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with     Preeclampsia, using Doppler ultrasound.   "
123145|NCT01674114|"     The purpose of this study is to investigate whether a regional-block (TAP block) in Caesarean     section will give a measurable benefit in form of reducing Morphine consumption as compared     to local infiltration of the wound with local anesthetic.   "
123146|NCT01674101|"     This application proposes a prospective clinical trial to evaluate the impact of adding a     focused physical therapy (PT) intervention to the preoperative regimen of individuals     diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine     if individuals diagnosed with a malignancy of the LE can participate in a 10 week     preoperative strengthening, stretching, and aerobic exercise regimen.   "
123147|NCT01674088|"     Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US     population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of     the disease still remains unclear. It has been hypothesized that patients with IBS have     alterations in the intestinal lining leading to release of toxic substances into the blood,     commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive     and invasive. The investigators will test a new breath test to measure leaky gut in both IBS     patients and subjects without IBS symptoms.   "
123203|NCT01673347|"     Using the concept of an implant acting as a spacer and stabilizer, the proposed study will     evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of     the great toe.   "
123148|NCT01674075|"     The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free     anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid     delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First     introduced in 2001, it uses compressed carbon dioxide for drug delivery into the subcutaneous     space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for both children     and adults.      Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth     et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no significant     untoward effects, including in children as young as 3 years old (Zempsky et al, 2008).     However, two recent cases of toxic serum lidocaine levels in pediatric patients at     Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning.     Both patients were administered local anesthetic using the J-Tip device prior to needle-stick     and toxicity screens returned with high levels of lidocaine (>6000 mcg/L).      Currently, there is a limited amount of literature available on the safety profile of the     J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following its     use, likely on the assumption that systemic absorption from the small amount of lidocaine     within the device should be negligible. The two pediatric cases highlighted above, seem to     suggest otherwise. The purpose of this pilot study is to assess the safety of the J-Tip     device on a small population of healthy adults and to determine if elevated lidocaine levels     are present systemically or locally. The primary outcome will be lidocaine serum levels     following the administration of the J-Tip device measured at the local site and two distal     sites to establish lidocaine serum levels following J-Tip administration. We expect lidocaine     levels to be undetectable.   "
123149|NCT01674062|"     This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with     Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on     trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the     efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and     clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840     milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab     will be administered at the same schedule the participant was following before entry into the     study. An additional cohort of participants at certain centers will receive pertuzumab     monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks.     These participants may have trastuzumab added to the regimen in the event of progression     during single-agent pertuzumab treatment.   "
123150|NCT01674049|"     The purpose of the proposed study is to examine the timing of post-exercise feeding on 15     hours post-exercise glycemic control and metabolic flexibility and in overweight and obese     young men with a family history of type 2 diabetes.      Aim 1 - To determine the temporal effects of post-exercise feeding (i.e., immediate     post-exercise vs. 3 hours post-exercise) on glycemic control, peripheral insulin sensitivity,     and metabolic flexibility (as evaluated by sleep RQ) in this same group of participants. We     hypothesize that a 3 hour delay in nutrient ingestion will promote significantly greater     improvements in glucose tolerance, metabolic flexibility, and peripheral insulin sensitivity     both immediately and several hours post-ingestion.   "
123151|NCT01674036|"     The objectives of this study are to assess the tolerability, safety and pharmacokinetic     parameters of Genz-682452 in healthy adult males, in two parts.      Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential     ascending single dose study;      Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment     crossover study with a minimum wash-out period; to obtain preliminary information on the     pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and     fasted conditions.      Subjects are not allowed to participate in more than 1 part of the study.   "
123152|NCT01674023|"     MicroRNAs are important regulators of many cellular functions but their expression profile in     human vitreous is still unclear. Aim of this study is to investigate microRNA expression     profile by PCR in human vitreous of patients with various vitreoretinal disorders and compare     with that of patients with macular holes which are suggested to be similar to that of healthy     subjects.   "
123153|NCT01674010|"     The primary purpose of this study is to determine whether ELND005 is effective in the     maintenance treatment of bipolar 1 disorder when added to other therapies.   "
123154|NCT01673997|"     The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol     Succinate Extended-Release Tablets 200 mg under fasting conditions   "
123155|NCT01673984|"     The purpose of this study is to demonstrate that treatment with a 6-monthly injection of     hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy     injections available for treating prostate cancer. The study will also aim to answer whether     both doctors and patients would prefer treatment with a 6-monthly injection rather than     injections every 3 months.   "
123156|NCT01673971|"     The investigators hypothesize that there are differences between infantile hemangiomas (IH)     during the proliferating and involuting phases and in response to medical treatment that can     be detected by optical tomography of these hemangiomas.   "
123157|NCT01673958|"     The aim of the present project is to compare the acute and chronic effect of stair descending     versus stair ascending exercise on muscle damage and performance in elderly males with     chronic heart failure.   "
123158|NCT01673945|"     The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in     the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent     organs, with the aim of establishing for which lesions and from which location the capability     of the FV-EUS will be superior, equal or, inferior to the CLA-EUS   "
123159|NCT01673932|"     The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear     cells (UCBMC) treatment of chronic ischemic stroke.   "
123160|NCT01673919|"     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who     completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg     intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.   "
123204|NCT01673334|"     We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates     of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic     tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield     than core biopsy.   "
123205|NCT01673321|"     This study compared the effects of dairy products, including milk and yogurt, with different     amounts of proteins on responses of appetite, glucose and insulin and on food intake at a     meal served 120 minutes later in healthy adult male individuals.   "
123206|NCT01673308|"     This is a Phase II study to evaluate the efficacy of second-line lenalidomide monotherapy for     myelodysplastic syndrome (MDS) patients who failed to hypomethylating agents.   "
123161|NCT01673906|"     The diagnostic work-up of patients suspected of having neuroendocrine tumours (NETs) has     traditionally been a challenging issue. The last two decades have been marked by the     application to use in the diagnosis of NETs of 3 newly available diagnostic techniques:     endoscopic ultrasonography (EUS), multidetector CT (MDCT), and more recently, positron     emission tomography using 68Ga-labelled octreotide analogues (PET). In a prospective study     conducted at a single referral centre that compared PET with conventional somatostatin     receptor scintigraphy and MDCT in diagnosis, staging and follow-up of patients affected by     NET, PET detected more primary and secondary lesions than other methods. Recent studies     investigated the clinical impact of PET in the management of patients affected by NET,     previously studied by MDCT. The investigators recently reported the results of the     investigation of 19 patients suspected of having primary pancreatic NET and studied by PET,     MDCT and EUS. The investigators preliminary data suggest that PET may be slightly more     sensitive than MDCT in detecting small (<2cm) pancreatic lesions; accuracy of PET and EUS is     probably similar. No prospective study has yet been devoted to evaluate the accuracy of PET     in the diagnosis and staging of primary duodenal-pancreatic NETs. Furthermore, the clinical     impact of the adjunct of PET to the traditional protocols of diagnosis and staging of these     tumours waits to be thoroughly evaluated. Thus the appropriate place of PET in the diagnostic     algorithm of patients suspected of having duodenal-pancreatic NET remains undefined.      The main aim of this project is to prospectively compare the accuracy of PET and MDCT in the     diagnosis and staging of patients suspected of having duodenal-pancreatic NETs. The     investigators hypothesised that PET is superior to MDCT in the diagnosis of these neoplasm     (the dimension of the study sample is estimated in order to detect a 10% difference). The     impact of PET on management plan of affected patients will also be evaluated. As a secondary     endpoint of the study, the investigators will compare EUS, PET and MDCT in the diagnosis of     primary duodenal-pancreatic NET. The study is designed as a multicentre, prospective,     non-randomised clinical trial. All patients will undergo MDCT, PET and EUS in this fixed     order.   "
123162|NCT01673893|"     The purpose of this registry is to determine if delivery of weight adjusted, in a large dose     with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for     primary coronary intervention lowers readmission rate. This is done in comparison to the     historical control of the Medicare/Medicaid readmission database. The registry will record     the use of the product during the index procedure, and determine whether or not the patient     was readmitted within 30 days, related to the index procedure.   "
123163|NCT01673880|"     This is a single-center, open-label, randomized crossover study being conducted in three     cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of     three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose     of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random     sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.   "
123164|NCT01673867|"     The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as     compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC)     after failure of prior platinum-based chemotherapy   "
123165|NCT01673854|"     The purpose of this study is to assess the safety profile of vemurafenib, 960 mg,     administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600     mutated advanced/metastatic melanoma.   "
123166|NCT01673841|"     In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with     relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that     previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might     be related to time delay issues and to the measurement technology.      42 consenting patients undergoing elective off-pump coronary artery bypass grafting were     included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead     for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed     just above the eyebrows, and the sensors of the other monitor were placed just above the     former sensors. The sensors placement was determined at random by a computerized     randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All     variables were recorded continuously. The study ended at the end of the operation.   "
123167|NCT01673828|"     This study will provide initial data on the safety and effectiveness of allopregnanolone in     improving neurobehavioral outcome and reducing mortality in adults with moderate and severe     traumatic brain injury.   "
123168|NCT01673815|"     Fundoscopy is an important aspect of the neurological examination, but can be challenging in     uncooperative children. This study explored whether viewing a video (selected by patient or     caregiver) during eye examination improves the success, duration and ease of pediatric     fundoscopy.      Hypothesis: Showing a short video clip during a fundoscopic exam will increase the     probability of successfully visualizing the optic disk and reduce the amount of time needed     to perform a fundoscopic exam in children between 1-8 years old.   "
123169|NCT01673802|"     The purpose of this project is to evaluate the role of gadoxetate (Eovist®) enhanced     dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to     address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher     resolution delineation of these often infiltrative tumors on single-source, Dual-Energy     Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable     with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to     aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the     hilar variety.   "
123170|NCT01673789|"     Alopecia Areata (AA) is one of the most common T cell-mediated autoimmune diseases, leading     to the chronic and relapsing hair loss. The prevalence of AA worldwide is 0.1 to 0.2%,     affecting an estimated 5.3 million people in the United States. To date, the clinical     therapies are limited and disappointed for the treatment of AA. Alternative approaches are     needed. Increasing evidence demonstrates that stem cells possess the function of immune     modulation. We established the Stem Cell Educator therapy by using cord blood-derived     multipotent stem cells (CB-SCs)(Zhao Y, et al. BMC Medicine 2012). A closed-loop system that     circulates a patient's blood through a blood cell separator, briefly co-cultures the     patient's lymphocytes with adherent CB-SCs in vitro, and returns the educated lymphocytes     (but not the CB-SCs) to the patient's circulation. Our clinical trial reveals that a single     treatment with the Stem Cell Educator provides lasting reversal of autoimmunity that allows     regeneration of islet beta cells and improvement of metabolic control in subjects with     long-standing type 1 diabetes (T1D), which is another most common T cell-mediated autoimmune     disorder in the United States. Here, we develop and explore the therapeutic effectiveness of     Stem Cell Educator therapy in AA patients.   "
123171|NCT01673776|"     This study is designed to compare the outcome of patients with proximal femoral fractures     with different perioperative regimes: a group with a multimodal intervention and a control     group.   "
123172|NCT01673763|"     The presented study is designed to analyze the efficacy of pancreatic stent insertion in     patients undergoing ERCP with accidental cannulation of the pancreatic duct.   "
123173|NCT01673750|"     This is an observational study that seeks to gather information about perceptions of body     image through the use of a one-time questionnaire completed by participants at the time of     study enrollment.      Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human     Immunodeficiency Virus (HIV) has become possible through the use of Highly Active     Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS     has transitioned from a terminal illness to one which is treated as a chronic condition. One     particular group that has been impacted tremendously by HIV in the United States is the     adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers     are beginning to examine ways in which the disease can affect one's physical health, mental     health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has     suggested that increased attention to and negative views of one's body image may be found at     a higher rate in this group. To our knowledge, very few studies have examined this     relationship in adolescents with HIV.   "
123174|NCT01673737|"     Primary Objective:      Part A - Monotherapy:      - To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and     either on a once or twice daily schedule, to patients with advanced solid tumors or     lymphomas.      Part B - Combination:      - To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination with     the recommended standard dosage of vemurafenib to patients with unresectable / metastatic     v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma.      Secondary Objectives:        -  To characterize the overall safety and tolerability profile of SAR260301 administered as          monotherapy (Part A) and in combination with vemurafenib (Part B).        -  To characterize the pharmacokinetic (PK) profile of SAR260301 administered as          monotherapy (Part A) and in combination with vemurafenib (Part B) as well as vemurafenib          PK in combination with SAR260301 (Part B)        -  To evaluate food effect on SAR260301 PK (Part A)        -  To assess preliminary antitumor activity according to Response Evaluation Criteria in          Solid Tumors (RECIST 1.1 criteria).        -  To assess preliminary antitumor activity using volumetric computed tomography (CT) or          magnetic resonance imaging(MRI)        -  To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor.        -  To evaluate PK/PD relationships.        -  To identify the recommended phase 2 dose of SAR260301 in combination with vemurafenib          (RP2D) (Part B only)        -  To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A          (CYP3A) (Part A)   "
123175|NCT01673724|"     The purpose of this study is to determine whether pramipexole and bromocriptine are effective     in the treatment of non-motor symptoms in Parkinson's Disease.   "
123176|NCT01673711|"     This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk     for lung cancer. Studying samples of urine in the laboratory from smokers who are at high     risk for lung cancer may help doctors learn more about biomarkers related to cancer.   "
123177|NCT01673698|"     The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific     evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and     exercise in the treatment of obese subjects with one or more obesity-related comorbid     conditions.   "
123178|NCT01673685|"     Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to     improve quality of life and other outcomes for patients with chronic obstructive pulmonary     disease.   "
123179|NCT01673672|"     The purpose of this study is to assess the therapeutic potential and safety/tolerability of     study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to     severe allergic asthma not sufficiently controlled on current standard controller therapy.      Altogether 360 patients randomized to 4 treatment groups will be included. The study compares     three dose strength with placebo. Each patient receives 7 injections of study drug or     undistinguishable placebo. Key outcome measures are patient reported parameters on their     asthma.   "
123180|NCT01673659|"     The objectives of this study is to demonstrate bioequivalence (comparable safety and     efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic     rhinitis.   "
123181|NCT01673646|"     To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in     Japanese patients with active acromegaly or pituitary gigantism. Primary objective is to     assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to <     2.5 µg/L and the normalization of IGF-1 at 3 months of study treatment.   "
123182|NCT01673633|"     One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular     involvement. Mostly involved joints in SSc were reported as wrist,     carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little     knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this     joint in SSc.   "
123183|NCT01673620|"     The purpose of this study is to assess the safety and tolerability of montelukast 10     mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.   "
123184|NCT01673607|"     The immune response at primary tumor has a major role in the prognosis of colorectal cancer     (CRC). Some studies suggest a prognosis value of cytotoxic T cell and memory T cells at     primary tumor greater than tumoral stage. There is no work in the literature that has     examined the prognosis value of the immune response in liver metastases. To study immune     cells (histology) and inflammatory response (cytokines) in liver metastases is a challenge to     understand the effectiveness of chemotherapy used in this situation.      The chemotherapy used in liver metastases of colorectal cancer also have effects on     non-tumoral liver tumor and therefore can interfere with postoperative complications of     hepatic resection. Sinusoidal dilatation is present in 20% to 80% of patients who received     oxaliplatin before hepatectomy. Steatosis is frequently observed after administration of 5-FU     alone or in combination with irinotecan. This steatosis may also be accompanied by     inflammatory lesions (steatohepatitis), especially after administration of oxaliplatin or     irinotecan and is associated with increased postoperative mortality. The hepatic toxicity of     new biological agents is not well known (cetuximab and bevacizumab). The mechanisms of     chemotherapy-induced toxicities are currently unknown. The main objective is to analyze the     profile of the immune response in liver metastases of CRC and find the link with the     radiological response. Measurements will be made by quantitative RT-PCR on frozen liver     biopsies. Secondary objective is to seek a correlation between the histological lesions     induced by chemotherapy and non-invasive tests for liver fibrosis. The secondary endpoints     are rate of immune cells, histologic response (percentage of tumor necrosis), disease-free     survival, the non-invasive test of fibrosis, the chemotherapy-induced liver injury, cytokines     and circulating angiogenic factors.   "
123207|NCT01673295|"     OBJECTIVE To test whether Rituximab (RTX) is efficacious to achieve complete renal response     (CR) in Lupus Nephritis (LN) patients with persistent proteinuria (≥1g/d) despite at least 6     months of standard of care (SOC).      STUDY DESIGN Investigator-initiated randomized international open multicentric 104-week     study.   "
123187|NCT01673568|"     Postoperative seroma formation is one of the most common complications after ventral hernia     repair. Although some seromas may not have clinical impact, postoperative seroma formation     often causes pain and discomfort and may even compromise wound healing. The use of     postoperative abdominal binder is often recommended after ventral hernia repair to prevent     seroma and diminish pain, but still with no scientific evidence. The primary aim of the     present study is to investigate the effect of postoperative abdominal binders after     laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life.     Secondary, we register seroma formation.      Method and material Randomized, controlled, multi-center, investigator-blinded study. A     minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power     calculations. Patients are randomized either to abdominal binder or no abdominal binder. The     abdominal binder is worn from immediately after the operation and continuously for 7 days,     night and day. Outcomes are based on patient self-reported registrations using Visual Analog     Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to     estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For     secondary outcome we use ultrasound to measure the volume of seroma formation. We use     Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test     for pain, discomfort and quality of life for the effect of time on inter- and intragroup     differences during the study period. P < 0.05 is considered significant.   "
123188|NCT01673555|"     This protocol is designed to explore whether short-term therapy with GSK1278863 affects PASP     under normoxic and hypoxic conditions in healthy volunteers. Healthy subjects will be     evaluated using echocardiography to estimate PASP based on the velocity of the tricuspid     regurgitant jet. Resting PASP will be assessed under normoxic (room air) conditions, as well     as after 30 minutes' exposure to 15% O2 before, during, and after short-term treatment with     GSK1278863.   "
123189|NCT01673542|"     Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of     dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the     puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required     for a 50% difference with the standard deviation of the control group, a significance level     of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35     patients per group.      The expected benefit is the reduction of pain at the skin puncture during the realization of     BAX.      Improving professional practice and quality care   "
123190|NCT01673529|"     A two part, randomized, double-blind, placebo controlled study to investigate the effects of     topical doses of SB705498 in healthy volunteers.   "
123191|NCT01673516|"     The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN) improves     the control of blood pressure (BP) in patients with treatment-resistant hypertension, as     compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a     predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) during     6 months intensive treatment program (receiving antihypertensive care according to the 2007     ESH Guidelines). Working hypothesis: When it is possible to disrupt the sympatho-renal axis     by RDN - BP reduction occurs to a greater extent and more rapidly than applying intensive     medical therapy using IHM.   "
123192|NCT01673503|"     The purpose of this study is to compare visual acuity, safety, predictability, corneal     biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule     extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after     ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.   "
123193|NCT01673490|"     Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90     subjects will be enrolled so that among them at least 57 will complete the 6-month treatment     period and evaluable for analysis.      -Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination     therapy for six month in BPH patients by monitoring category, frequency and severity of     adverse events encountered during the treatment period.      -Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin     combination therapy with regard to symptom improvement in BPH patients by monitoring and     analyzing of changes in IPSS and Qmax after 6 months of treatment.   "
123194|NCT01673464|"     The main purpose of this study is to prospectively examine changes in Brain Network     Activation(BNA)following concussion in high school athletes. In addition, the study will     examine the relationship between changes in BNA to symptoms, cognitive performance and     vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high     school athletes with concussion.   "
123195|NCT01673451|"     This is a single-center, randomized, double-blind, placebo-controlled, sequential,     multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy     adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening     dosing).   "
123196|NCT01673438|"     This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of     aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles     in subjects with advance solid tumors.   "
123197|NCT01673425|"     The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be     effective in children but less effective in adults. Our hypothesis is that this relative     failure is due to adults having enough anti-flu IgA antibody in nasal secretions to     neutralize the weakened vaccine virus.   "
123198|NCT01673412|"     This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU)     characteristics known as possible prognostic markers, and which sociodemographic and     psychologic factors associated with VLU are associated with complete healing at 24 weeks.   "
123199|NCT01673399|"     In this study the investigators compare the usual way of embryo transfer (without medication)     with an embryo transfer while administering oxytocine antagonist. This to improve     implantation and increase the pregnancy rate.   "
123208|NCT01673282|"     This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in     clinical practice and will also evaluate the subsequent change in the drug load of patients     after addition of VIMPAT® to their treatment regimen.   "
123668|NCT01667276|"     This is an observational study to assess the experience of current depot medroxyprogesterone     acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject     and offer recommendations for the introduction of this method.   "
123211|NCT01673243|"     Little is known about what factors influence parental decisions to participate or to decline     participation in tobacco trials offered in the pediatric clinical setting. Further, it is     unclear what proportion of parents treated in our setting would elect to receive formal     assistance with quitting smoking or consider alternative approaches that could facilitate     eventual smoking cessation. While the recommendation to parents is generally to quit smoking,     some may be unwilling or unable to quit and prefer more achievable alternative treatment     goals. Some parent smokers may be unlikely to participate in an intervention aimed only at     cessation but would be willing to participate in an intervention focused on establishing     smoke-free environments for their child. Parents are typically not offered a choice regarding     the type of intervention they receive and many interventions are not tailored to their     readiness to quit smoking or designed to reach multiple family members in the home who may     also smoke. Quitting smoking and establishing smoke-free homes and cars are distinct, yet     challenging, goals for parents and families. Both approaches can directly, or indirectly,     help parents to quit smoking, reduce the child's exposure to second-hand smoke (SHS), and     initiate an important dialogue with families about tobacco control. How parental     acceptability of smoking interventions is affected by the context of their child's treatment     for cancer or SCD, as well as survivorship, warrants further study.   "
123212|NCT01673230|"     Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when     pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires     adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices     of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not     been showed until now when LVEF is altered.   "
123213|NCT01673217|"     This phase I trial is studying the side effects and best dose of decitabine when given     together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating     patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal     cancer. Drugs used in chemotherapy, such as decitabine and pegylated liposomal doxorubicin     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Vaccines made from a peptide or antigen may help     the body build an effective immune response to kill tumor cells. Giving combination     chemotherapy together with vaccine therapy may kill more tumor cells   "
123214|NCT01673204|"     Worldwide, the most common cause of chronic kidney disease (CKD) and end stage renal disease     (ESRD) is diabetes. Unlike the past, in south korea, diabetes account for more than 40% of     ESRD. According to WHO reports in 1998, 100 million people had type 2 diabetes in 1997, and     there is expected to increase by 300 million people in 2025. In addition, the expected     survival time of patients with diabetes increase compared to previous. In the future, ESRD     due to type 2 diabetes is expected to have a significant impact on the health industry.     Therefore, prevention of progression to CKD and ESRD in diabetic patients is important to     aspect of national health and economic problems. How to stop the progression of diabetic     nephropathy is part of modern medicine to be solved.      Strict glycemic control, blood pressure regulation, and use of renin-angiotensin system (RAS)     blockers inhibit the development and progression of diabetic nephropathy. Microalbuminuria in     diabetic patients has been recognized as a predictor of progression of diabetic nephropathy.     Thus, the prevention of elevated urinary albumin excretion is an important therapeutic target     for the prevention of renal and cardiovascular events.      In patients with diabetes and hypertension, the drugs that block the RAS are used to treat     proteinuria, but still a large number of patients with proteinuria are uncontrolled. In     addition, ACE inhibitors or ARB agents actually have a limited effect on reducing the risk of     cardiovascular or renal outcome. Also, sulodexide or pentoxyphylline which is reducing     proteinuria have some weak evidence in terms of efficacy and safety. Therefore, the     introduction of new alternative drugs are required.      Already several study reported that calcitriol or paricalcitol in the renal injury model have     renopreventive effect. In addition, in diabetic renal injury mice model reported that vitamin     D receptor deficiency leads to glomerulosclerosis. Inhibition of the RAS with combination of     paricalcitol and RAS inhibitors effectively prevent renal injury in diabetic nephropathy.     Recently, Dick de Zeeuw et al reported that addition of paricalcitol to RAS inhibition safely     lower residual albuminuria in patients with diabetic nephropathy. Recent studies reported     that elevated concentrations of serum markers of the TNFα and Fas-pathways are strongly     associated with decreased renal function in diabetic patients. However, the role of these     markers in early progressive renal function decline are not clear. Therefore, the objective     of this study is to identify the renoprotective effect as an new treatment of activated     vitamin D (Calcitriol) indicating the TNF-α-related anti-inflammatory action and to seek the     role as an important biomarker that the changes of TNFR in diabetic nephropathy can predict     response to treatment.   "
123215|NCT01673191|"     There is a need to find an effective therapy for diabetic patients who develop macular edema     after cataract surgery.   "
123216|NCT01673178|"     This is a trial in obese subjects who have poor lipid control with and without Type 2     diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of     PF-05231023   "
123217|NCT01673165|"     The purpose of this study is to determine if the use of fortified skimmed mother's milk is a     safe alternative to specialized formula in the treatment of chylothorax following     cardiothoracic surgery.   "
123218|NCT01673152|"     This study is designed to assess the effect of oligofructose administration for 12 weeks on     Body Mass Index (BMI) of overweight and obese children.   "
123219|NCT01673139|"     This is a substudy of Generation 100. The investigators will follow the persons with atrial     fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial     fibrillation, symptoms, use of health services or echocardiographic findings.   "
123220|NCT01673126|"     Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to     the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and     attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised     (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a     double-blind sham-controlled experimental design.   "
123244|NCT01672814|"     This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure,     also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen     crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in     patients with keratoconus.   "
123228|NCT01673022|"     Description:      This is a multi-institutional study investigating the sensitivity and negative predictive     value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after     cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or     cervical cancer at the time of their robotic surgical staging.      Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by     sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph     nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel     pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine     pathologic processing according to standard of care for these surgical procedures. The     pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity     and negative predictive value in their ability to detect metastatic disease.   "
123221|NCT01673113|"     Cryolipolysis with Zeltiq CoolSculpting device is a novel method of non-invasive fat removal.     The technique works by application of cold plates to the skin surface for a single cooling     cycle lasting 60 minutes, after which a cold-induced inflammatory panniculitis leads to     selective loss of fat. There is no histologic evidence of necrotic or inflammatory damage to     skin or nerves, however a single small human study has reported prolonged temporary altered     sensation (hypoesthesia) in the area of cryolipolysis procedure. This hypoesthesia seen in     about 2/3 of patients, is completely reversible, lasts up to 8 weeks after treatment, and     suggests that cooling under these conditions can temporarily alter sensory nerve function.      The purpose of this study is to further characterize the reversible cutaneous sensory     function alteration after cryolipolysis with Zeltiq CoolSculpting device. Using multiple     modalities of sensory nerve function we hope to elucidate the details of cryolipolysis     induced sensory nerve alteration.   "
123222|NCT01673100|"     The purpose of this study is to test the feasibility of using targeted daily cell phone     interaction to facilitate behavior change for physical activity in previously-sedentary     individuals who have recently undergone a percutaneous coronary intervention (PCI).   "
123223|NCT01673087|"     Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient     way to evaluate the biological impact of day-to-day stressors that people encounter as they     go about their lives, since saliva is so easy to collect. However, the biological meaning of     saliva cortisol measures has never been carefully examined. The goal of this study is to     collect saliva from a large group of people as they go about their every-day lives, to     measure their cortisol levels, and then study them in the laboratory where Investigators can     learn more about how their stress response system (which produces cortisol) is really     functioning. Investigators can then determine much more precisely what saliva cortisol levels     really mean in terms of stress system biology. This will allow investigators to obtain much     more useful information from the next decade of research on naturalistic stress and its     biological impact using saliva cortisol measures, helping investigators to understand how     stress undermines health and how to combat this effect.   "
123224|NCT01673074|"     The primary objective of the study is to determine the maximally tolerated photodynamic     therapy (PDT) dose and drug-light interval of PDT using light and HPPH in patients with     pleural malignancy who have undergone a maximal resection.   "
123225|NCT01673061|"     Cutaneous abscesses (boils) are collections of pus or infection in the skin, and are a     frequent reason for emergency department visits. The only proven cure for abscesses is     cutting them open and allowing the infection to drain, but this procedure is often painful.     Currently, the usual method of pain control is to inject a numbing medication (lidocaine)     into the site, but this injection itself is often painful and sometimes does not offer full     pain relief. Although there has been some research into the use of non-injected numbing     agents as another option, no studies have looked at the use of numbing sprays (vapocoolant)     in this context specifically. The hypothesis of this study is that numbing spray is as good     as injected numbing medication at relieving pain in patients having small abscesses opened     and drained. This theory will be tested by taking two groups of patients having small     abscesses drained in the Emergency Department, and assigning one group to get a numbing     injection, and the other to get a numbing spray. Their levels of pain and satisfaction will     be recorded before, during, and after the procedure, and the two groups will be compared.   "
123226|NCT01673048|"     Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced     diaphyseal femoral fractures in children. However, some literature report high complication     rates (10-50%) in complex fractures. Data of our own patients with special emphasis on     complications showed also mediocre results. Thus, a biomechanical study was conducted to     search for modifications. In this study the stiffness with a 3rd nail implanted was compared     to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde     ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral     fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd     from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm).     Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression     (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal     rotation and 9° compression directions implantation of 3 nails became standard treatment for     all dislocated femoral fractures at our department.      All patients were followed prospectively. The following data was collected: Type of     osteosynthesis, any kind of complication (additional procedures like cast or external     fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time     until full weight bearing and time until implant removal. At follow-up the legs were     controlled for a possible length discrepancy and a possible deviation of axis. Patients`     satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further     on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1     and 3-4 months (dependend on age).      Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing,     fracture, femur, treatment, children, adolescents.   "
123227|NCT01673035|"     Background      Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with     functional disability. Cognitive behavior therapy (CBT) and behavioral stress management     (BSM) have been showed to be effective in the treatment of severe health anxiety. The     mechanisms of the treatments are however poorly understood. In addition, effective     psychological treatments are accessible to only a few. One prior RCT has shown that     internet-based CBT could be effective in comparison to waiting list controls. More studies on     internet-based CBT is essential to establish evidence. In addition, few studies with     sufficient power have investigated the effect of CBT in comparison to other active     treatments.      Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to     behavioral stress management (n=110) for adult participants with severe health anxiety. BSM     is considered a comparison treatment for two reasons: it has been shown to be effective and     it lacks exposure and response prevention, which is suggested to be an important mechanism in     CBT.      Participants in both treatments are expected to be significantly improved on measures of     health anxiety. Participants receiving CBT are expected to be significantly more improved     compared to participants receiving BSM.   "
123267|NCT01672515|"     Stroke is one of the three leading causes of human death, and a major cause of adult     disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent     cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce     infarct size of cerebral infarction. Investigators hypothesized that postconditioning would     reduce infarct volume of ischemic stroke patients.   "
123669|NCT01667263|"     Randomized, open-label, multicentre study to compare the efficacy and safety of ATRA plus     danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.   "
123232|NCT01672970|"     This multi-center observational study will evaluate the use of RoActemra/Actemra     (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on     RoActemra/Actemra treatment according to the local label will be followed for 6 months.   "
123233|NCT01672957|"     This observational study will evaluate renal function in participants who underwent renal     allograft transplantation and are started on combined immunosuppressive treatment containing     mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months     following transplantation.   "
123234|NCT01672944|"     The purpose of this study is to evaluate English and Spanish language educational materials     that inform the community about a type of cancer research that involves the collection,     storage, and processing of biospecimens. Part A of this study involved creating surveys about     biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to     evaluate education materials about biospecimen donation and research.      Phase II consists of two independent randomized controlled trials. Each trial is being     conducted independently to test English and Spanish language materials (75 subjects each).   "
123235|NCT01672931|"     We believe that there is an association between BMI and oocyte diameter in women undergoing     IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF.     One group will have BMI 20-25 and the other group will have BMI above 30.   "
123236|NCT01672918|"     Background:      - Autoimmune lymphoproliferative syndrome (ALPS) is a genetic disorder of the lymph system.     People with ALPS often have swollen lymph nodes, especially in the neck and armpit. They also     have a much higher risk of developing lymphoma. It is not always easy to determine whether     the swollen lymph nodes are caused by ALPS or by lymphoma. Researchers want to see whether     different imaging studies can show the difference between ALPS and lymphoma. The studies used     will be positron emission tomography (PET) and computed tomography (CT). Researchers will use     a drug called fluorodeoxyglucose (FDG) to look at the lymph nodes.      Objectives:      - To see how well imaging studies can distinguish between swollen lymph nodes caused by ALPS     or by lymphoma.      Eligibility:        -  Individuals must be 5 years of age or older and enrolled on the National Institutes of          Health natural history study of ALPS.        -  Participants should either have lymphoma or have symptoms that suggest possible          lymphoma.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have an FDG-PET/CT scan. It will be performed according to standard          procedures.        -  If the results of the scan do not show lymphoma, participants will stay on the study for          1 year for clinical follow up. They may have a second FDG-PET/CT scan if there is a          change in symptoms. Such changes include further enlargement of lymph nodes, unexplained          fevers, or weight loss.        -  If the results of the scan show evidence of new or worsening lymphoma, treatment on this          study will end. Further tests based on clinical symptoms, including a lymph node biopsy,          may be done under the ALPS natural history study to rule out or make a diagnosis of          lymphoma.   "
123237|NCT01672905|"     RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the     laboratory may help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in     samples from patients treated for prostate cancer on trial ECOG-E9802.   "
123238|NCT01672892|"     RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill     tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to     the tumor may kill more tumor cells and cause less damage to normal tissue.      PURPOSE: This randomized phase III trial is studying two different methods of radiation and     their side effects and comparing how well they work in treating endometrial and cervical     cancer after surgery.   "
123239|NCT01672879|"     This study is to evaluate the safety and efficacy of simtuzumab (GS-6624) in adults with     compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2     phases:        -  Randomized Double-Blind Phase        -  Open Label Phase (optional)   "
123240|NCT01672866|"     This study will evaluate whether simtuzumab (formerly referred to as GS-6624) is effective at     preventing the histologic progression of liver fibrosis and the clinical progression to     cirrhosis in participants with non-alcoholic steatohepatitis (NASH).      It will consist of 2 phases:        -  Randomized Double-Blind Phase        -  Open Label Phase (optional)   "
123241|NCT01672853|"     The purpose of this study is to evaluate whether Simtuzumab (GS-6624) is effective at     preventing the progression of liver fibrosis in subjects with PSC.   "
123242|NCT01672840|"     The proposed study Dose And Response to Cocoa (DARC), will examine variation in dose of     cocoa-containing product consumption over an 8-week period and assess effects on blood     pressure, endothelial function and arterial stiffness. The randomized, controlled, modified     Latin square parallel design will compare the effects of two doses of cocoa consumption on     blood pressure, endothelial function and arterial stiffness in 120 adults with stage 1     hypertension.   "
123243|NCT01672827|"     To Evaluate the Effectiveness of an Electronic Training Program for Orienting and     Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.   "
123245|NCT01672801|"     The main purpose of this study is to test the effectiveness of nimodipine in preventing a     luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene     citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation     to allow adequate recruitment of follicles, proper maturation of a dominant follicle before     ovulation, and effectively time insemination with semen to allow fertilization of a mature     egg to occur.      The investigators are also conducting this study to determine medication side effect profile     (including lightheadedness or dizziness from low blood pressure or rapid heart rate,     headache, and nausea), patient treatment compliance, and clinical pregnancy (positive     pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle     stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on     these hormones.      As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of     gonadotropin releasing hormone in animal and preliminary human studies. The investigators     hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge     during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients     undergoing assisted reproduction with intrauterine insemination (IUI).   "
123246|NCT01672788|"     The primary objective of this trial is to establish bioequivalence of two FDC tablets and the     single tablets when administered together after a high fat high caloric meal.   "
123247|NCT01672775|"     The purpose of this study is to evaluate the safety and pharmacokinetics and assess the     immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).   "
123248|NCT01672762|"     This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to     diabetic patients.   "
123249|NCT01672749|"     The foremost challenge when managing early onset scoliosis (curve deformity before the age of     10) is to prevent curve progression while maintaining growth of the spine. Current treatment     options require repetitive interventions as the spine and the child grow. This study will     compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué     Trolley screws      Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer     re-operations after 3 years of follow-up (FU) than patients included in the comparison group   "
123250|NCT01672736|"     This is a multi-center, open-label, non-randomized study. Patients will receive ASP7487     (OSI-906) in combination with bortezomib and dexamethasone. Phase 1 involves dose escalation     of the combination, whereas Phase 2 involves the expansion of ASP7487 (OSI-906) combined with     bortezomib and dexamethasone at the MTD to establish the ORR. This trial will accrue patients     with relapsed or relapsed/refractory MM - a disease state for which bortezomib is approved to     treat by the FDA and Health Canada. The combination of ASP7487 (OSI-906) with bortezomib is     supported by pre-clinical work in MM in which the combination with an IGF1-R inhibitor     enhances anti-tumor activity of bortezomib.   "
123251|NCT01672723|"     From birth we rely on others for comfort and care and derive pleasure from being together.     Research from the fields of health psychology, social psychology, and public health converge     to highlight the importance of having and maintaining good relationships for overall health.     Indeed, having close friends and family and feeling connected to them has been called a basic     need, similar to our need for food and water. It may not be a coincidence then that feelings     of connection rely on similar systems in the body as other needs that are both basic and     highly pleasing and rewarding. For instance, its possible that opioids, a substance in the     body associated with pleasant, euphoric feelings, may also be important for connecting with     others. This study will examine the role of opioids in feeling connected to others by     administering a drug called naltrexone, that effects opioid processing in the body, on     perceptions and feelings toward a number of tasks in the lab. Additionally, to assess the     effects of naltrexone outside of the lab, participants will complete daily diary responses     via text and online surveys.      40 participants will take both placebo and naltrexone. Participants will complete two     sessions, one in each drug condition, in which they complete a number of tasks including     reading messages on a computer screen, holding a number of objects, and viewing images while     undergoing electric shocks. Participants will also complete a daily diary for 14 days while     on naltrexone and placebo. Prior to these lab sessions participants will be screened at     UCLA's Clinical & Translational Research Center (CTRC) to ensure that they are healthy and     that it is safe for them to take the study drug.      We hypothesize that people will report feeling less socially connected when on naltrexone     compared to placebo and will show subsequent changes in social behavior outside of the lab.   "
123252|NCT01672710|"     Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is     characterized by persistent memory and concentration problems, headaches, fatigue and muscle     and joint pain. It is not known what causes the illness, but exposure to chemicals is     suspected. The Hubbard detoxification program consists of exercise and sauna therapy together     with administration of several dietary supplements, particularly crystalline niacin used at     increasing concentrations over a period of about four weeks. The investigators hypothesize     that this program will reduce symptoms, as tested by administration of cognitive and quality     of life tests and serum clinical chemistry tests.   "
123253|NCT01672697|"     Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in     the post-partum period after a vaginal delivery complicated by genital trauma help to improve     a woman's quality of life, specifically in regard to anal incontinence. To be able to study     this, the investigators need to know how well the muscles of a woman's pelvic floor function     after a vaginal delivery and this requires measuring their strength during a pelvic exam. At     present, there are no studies that have looked at whether the intervention of PT/BT improves     a woman's anal incontinence quality of life after sustaining genital trauma during vaginal     deliveries   "
123254|NCT01672684|"     This randomized phase I trial studies at-home group video calling sessions in quality of life     in rural patients with breast cancer. At-home group video calling support sessions may     improve the well-being and quality of life of women who have breast cancer   "
123255|NCT01672671|"     The purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy in     correlation with BRCA1-associated DNA repair dysfunction in patients with early triple     negative breast cancer.   "
123268|NCT01672502|"     Firefighters frequently work extended duration shifts and long work weeks which have adverse     effects on alertness, health, safety and performance. This protocol uses a survey instrument     to examine the effects of extended duration shifts on safety outcomes (e.g., motor vehicle     crashes, accidents, injuries), health (e.g., diagnosis and treatment of sleep disorders,     improved general health indices, decreased number of sick days), and performance (e.g.,     decreased response time). This study will expand understanding of the nature, scope, etiology     and consequences of firefighter fatigue and increase our ability to develop guidelines that     can be generalized across fire departments throughout North America. This study could provide     an avenue to make lasting policy improvements that could enhance the safety, health, and     performance of firefighters.   "
123256|NCT01672658|"     The goal of this clinical research study at RIC is to determine the value and benefit of the     SK multimodal balance training system through independent clinical evaluations. The     functional benefit of the SK Balance system will be measured by any improvements in balance     and functional assessments.      This study is primarily funded through Engineering Acoustics as a subcontract for a phase II     Small Business Innovation Research by the Department of Defense.      3) Hypotheses & Research Objectives and Purpose:      The specific research questions to be addressed are:        1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT          intervention on balance and functional gait measures in mild traumatic brain injury          (mTBI) participants.        2. How do SKBS measurement tools compare to standard clinical assessments of gait and          balance in mTBI patients The purpose of this clinical research study is to compare the          value and benefit of the SK multimodal balance training system in combination with          traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone          through independent clinical evaluations. The functional benefit of the SK Balance          system will be measured by any improvements in clinical measures of balance, functional          mobility, and gait assessment.   "
123257|NCT01672645|"     The purpose of this study is to determine the safety and tolerability of multiple doses of     PF-05402536 and PF-06413367 in healthy adult smokers.   "
123258|NCT01672632|"     It has been shown that large fat cells are associated with more risks for insulin resistance     and more cardiovascular risk factors such as high cholesterol or triglycerides.   "
123259|NCT01672619|"     Being the craniostenoses sutural basically a disease, the fact that the brain being trapped     in an enclosure that does not have complacency required to accompany their growth constitutes     the challenge of treatment, which aims to restore the complacency of the suture and correct     the stenotic compensatory cranial deformity.      This paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided     by the use of springs distracting.   "
123260|NCT01672606|"     This study describe the effect of partial neuromuscular blockade of rocuronium on the acute     hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.   "
123261|NCT01672593|"     Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of     low-output ECFs. The primary objectives of this study are to compare the clinical efficacy,     safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin     sealant Bioseal® in the management of patients with low-output volume ECFs.   "
123262|NCT01672580|"     This project will examine the spread of health interventions with a randomized control trial     design by introducing public health interventions in 32 villages in the Honduran Department     of Lempira. Based on identified public health needs in the region, namely improved drinking     water and diet, this study will provide training on the use of chlorine (sodium hypochlorite)     for water purification and multivitamins for nutritional supplementation. In some villages,     individuals selected for their social connectedness will be trained and given coupons that     can be redeemed for either chlorine bleach or multivitamins, and these persons will be asked     to spread this information and distribute coupons to four people of their choosing. In other     villages, individuals selected at random will receive the same training, materials, and     instructions. A second wave of coupon distribution will provide coupons to those who received     a coupon from the original seed groups so that they may disperse these coupons further out     in the social networks. Over the following months, study investigators will look at how     knowledge of these health practices, and uptake or and adherence to the practices, spreads     throughout the villages.      More specifically, the investigators will examine the speed and extent of spreading of these     new health practices after introducing them to three different initial seed groups: (1)     people chosen on the basis of being named as a friend by many people in their village, (2)     people chosen based on being named as a friend by a randomly chosen individual, and (3) a     group of randomly chosen individuals. It is hypothesized that spread will occur faster and/or     to a greater extent when the intervention is started in groups 1 and 2 versus group 3     (control group).   "
123263|NCT01672567|"     The purpose of this study is to determine the effects of daily consumption of eggs or egg     substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in     participants with clinically established coronary heart disease (CHD).   "
123264|NCT01672554|"     This research will explore whether Quetiapine XR used primarily to treat psychosis may also     cover for comorbid anxiety disorder and offer advantages in patients with schizophrenia and     comorboid anxiety disorder. Preliminary data on pharmacological properties of Quetiapine and     its metabolites and intuitive impression from our clinical experience lead to believe that     Seroquel XR use in monotherapy may offer advantages over other antipsychotics in treating     co-morbid anxiety disorder in patients suffering from schizophrenia. This open label switch     study conducted in a schizophrenic population intends to verify this hypothesis.   "
123265|NCT01672541|"     The Dating Matters: Strategies to Promote Healthy Teen Relationships Initiative intends to     promote respectful, nonviolent dating relationships among adolescents living in high-risk,     urban communities. CDC has developed a comprehensive approach to promoting respectful,     non-violent relationships based on current evidence based and evidence informed strategies.     This comprehensive approach includes: school-based curricula for 6th, 7th, and 8th grade     students; separate parent programs for parents of 6th, 7th, and 8th grade students; a     communications campaign involving social media and near-peer brand ambassadors; an online     training about dating violence for educators; policy assessment at the school or community     level; and development and validation of school and community level indicators of teen dating     violence. Additionally, schools assigned to the comprehensive condition will also receive     intensive training and technical assistance to support implementation of these components.     Among 4 U.S. sites, 44 schools will be randomly assigned to implement either the Dating     Matters comprehensive approach or the standard of care approach, which we are     operationalizing as Safe Dates, a an evidence based student curriculum for 8th graders. We     hypothesize that the comprehensive approach will be more effective than the standard approach     at preventing the perpetration and victimization of teen dating violence over time and at     promoting positive relationship behaviors over time.   "
123266|NCT01672528|"     A multicentre, prospective observational study to develop, evaluate and validate Patient     Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic     cardiac arrhythmias   "
123271|NCT01672463|"     This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot     cohort of human recurrent malignant glioma patients. All patients will have been previously     treated with the standard-of-care treatment which includes surgical resection, radiation and     chemotherapy, and in some cases treatment for recurrent disease with investigational agents     or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established     by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic     acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on     this protocol.   "
123272|NCT01672450|"     This is a single center, open phase I dose escalation study. This study will assess the     highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2     (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous,     subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the     drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the     combination.   "
123338|NCT01671592|"     This study will evaluate the safety and feasibility MRI tracking of a vaccine produced from a     persons cancer cells injected intradermally once a day for 3 consecutive days. One of the     daily doses will contain a chemical that can be detected by an MRI. That will be either the     1st or 3rd day of the 3 day course. On that day MRI scans will be performed 6 and 24 hours     after the injection on that day. Patients may be able to receive booster doses every 1-2     months   "
123273|NCT01672437|"     The Danish regions aim to implement antenatal education in small groups for all expectant     parents. The effects of general antenatal education for childbirth or parenthood, or both,     remain largely unknown. Also it is unknown if antenatal education in small groups is superior     to antenatal lectures which is currently standard care.      The aim of the trial is to evaluate if antenatal birth and parent preparation in small groups     can increase parenting resources thereby easing birth and creating a smoother and less     stressful transition to parenthood among the participants, compared to those allocated to     standard care. This in turn is hypothesized to improve health and thriving among newborn     families and affect their use of healthcare services. A thorough process evaluation will be     conducted highlighting enabling factors and barriers to the implementation. Finally     cost-effectiveness analysis will be conducted.      Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the     Copenhagen Capital Region of Denmark.      Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due     to give birth at Hvidovre Hospital. Being legally able and willing to provide signed consent,     and being fluent in Danish.      Women are randomised to receive:        1. A research-based birth and parenting program. The intervention consists of 4 sessions in          small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of gestation,          and a post-natal session 5 weeks after expected due date.        2. Standard care (control group). The pregnant woman and her partner are offered two          antenatal lectures in an auditorium.      The allocation of participants to the intervention will be 1:1 to the intervention and the     control group.      Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks     post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric     database, and via the national registers. Analyses will be intention to treat. Subgroup     analysis will be conducted in relation to personal and demographic characteristics. Process     evaluation will be conducted using questionnaires and qualitative interviews. The incremental     societal cost of the intervention will be computed and compared to the measured outcomes in a     cost-effectiveness analysis.      Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention,     use of health care services, self-efficacy, divorce.   "
123274|NCT01672424|"     Hypothesis: The volume of gastric contents will be the same for a high protein drink versus     ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring     parturient.      Specific Aim: To determine the volume of gastric contents at various time intervals (every 20     minutes for 2 hours) in patients with an epidural that are given a high protein drink versus     those that are given ice chips, with ultrasound.   "
123275|NCT01672411|"     In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of     214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have     been developed in order to identify PCa while it is still confined to the prostate gland.      The two most commonly used tests are digital rectal examination and serum prostate-specific     antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for     PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels     may change as result of physical activity, sexual activity, in the presence of benign     prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of     PCa.      A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering     prostate biopsy and large programs for the early detection of prostate cancer have shown that     almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a     PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected     (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for     identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml;     moreover, the levels of free and bound PSA have been assessed, together with PSA density (the     rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem     to have some validity for detecting prostate cancer.      Recent studies have shown that other new biomarkers could be used in the diagnosis of early     prostate cancer as they showed a higher sensitivity and specificity. In the last two years,     several investigators showed that PSA isoform [−2] proPSA (p2PSA) and its derivatives,     namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA /     free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA     (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa     aggressiveness at biopsy.      The aim of this study is to confirm the diagnostic and prognostic predictive value of     prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index     in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.   "
123276|NCT01672398|"     Background: Patients hospitalized with complex chronic conditions frequently experience     preventable short-term readmissions due to inadequate transition support. Although structured     discharge planning with telephone follow-up improves transition outcomes, these services     often are unavailable, and proactive outreach is often inadequate once the patient returns     home. Informal caregivers are invaluable for ensuring successful transitions, but many     patients live alone, have an in-home caregiver who is struggling with competing demands, or     live at a distance from adult children or other potential sources of support. New models are     needed for transition support that include low-cost technologies and more structured     assistance for patients' informal caregiving network, while providing patients' clinical     teams with the information they need to avert health crises.      Objectives: Consistent with Agency for Healthcare Research and Quality goals to improve     transitions using accessible health IT, we will evaluate a novel intervention designed to     improve the effectiveness of transition support for common chronic conditions via three     mechanisms of action: (a) direct tailored communication to patients via automated calls post     discharge, (b) support for informal caregivers via structured feedback about the patient's     status and advice about how they can help, and (c) support for proactive care management     including a web-based disease management tool, automated alerts about potential problems, and     the capacity for asynchronous communication with patients and their caregivers. Specifically,     the trial will determine: 1) whether the CarePartner intervention improves patients'     readmission risk and functional status; 2) the impact of the intervention on patients'     self-care behaviors and the quality of the transition process; and 3) whether the     intervention improves caregiver burden and stress levels.   "
123298|NCT01672112|"     The efficacy of codeine is dependent on its demethylation to morphine. This extent of     demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic     variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.      Codeine has been the mainstay of analgesia for patients after craniotomy for many years.     Traditionally, craniotomies were not thought to be very painful procedures, hence the use of     codeine, a moderately potent opioid (when compared to morphine).      However, in recent years, it has been found that up to 70% of post-craniotomy patients have     moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies     have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and     patients on these stronger opioids generally had lower pain scores and better satisfaction.      No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral     codeine.      Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain     relief in post-craniotomy patients.   "
123299|NCT01672099|"     In this study, the beneficial effect of a nutrient enriched dairy product will be     investigated on vitamin K-status. To achive this benefit, the study product contains extra     vitamin K2. In addition, extra dairy minerals have been added to the study product that may     support general health.   "
123337|NCT01671605|"     There is currently little understanding of macrophage cholesterol homeostasis and foam cell     formation across the spectrum of CKD. We hypothesize that an inverse relationship exist     between the severity of CKD and processes underlying foam cell formation, and that the     relationship becomes independent of serum lipoprotein levels as renal function declines. We     propose to systematically examine scavenger receptors and cholesterol uptake as well as     cholesterol transporters and efflux mechanisms in individuals with normal renal function,     patients with moderate CKD. We further propose to determine if processed contributing to foam     cell formation are related to the plasma lipid profile and if the relationship is modified by     co-morbidities, such as diabetes, obesity, systemic inflammation which are common in this     population and directly influence vascular integrity. These data will be critically important     to understand when the abnormality starts and will provide crucial information.   "
123277|NCT01672385|"     Background: Older hospitalized adults frequently experience preventable short-term     readmissions due to inadequate transition support. Although proactive telephone follow-up     improves transition outcomes, these services often are unsystematic and of low intensity.     Informal caregivers are invaluable for ensuring successful transitions, but many patients     live alone, have an in-home caregiver who is struggling with competing demands, or live at a     distance from adult children or other potential sources of support. New models are needed for     transition support that include low-cost technologies and more structured assistance for     patients' informal caregiving network, while providing patients' clinical teams with the     information they need to avert health crises.      Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a     novel intervention designed to improve the effectiveness of transition support for older     adults with common chronic conditions via three mechanisms of action: (a) direct tailored     communication to patients via regular automated calls post discharge, (b) support for     informal caregivers living outside of the patient's household via structured feedback about     the patient's status and advice about how they can help, and (c) support for proactive care     management including a web-based disease management tool, automated alerts about potential     problems, and the capacity for asynchronous communication with patients and their caregivers.     Specifically, the trial will determine: 1) whether the CarePartner intervention improves     patients' readmission risk and functional status; 2) the impact of the intervention on     patients' self-care behaviors and the quality of the transition process; and 3) whether the     intervention improves caregiver burden and stress levels.   "
123278|NCT01672372|"     The proposed study is a 60-day, randomized, double-blind, placebo-controlled trial to     evaluate the efficacy of a methylated vitamin B complex nutritional supplement (Max Stress     B™) for improving depressive and anxiety symptoms according to the Beck Depression and     Anxiety Inventories, respectively, in 60 patients (18+ years of age) diagnosed with major     depression or other forms of depressive disorders and an elevated level of homocysteine (> 10     µmol/L) at baseline. Secondary outcomes will include anthropometrics for body composition,     blood pressure and pulse, level of physical activity, dietary intake, and quality of life.     Participants will be assessed at baseline and 30 and 60 days. The study will consist of two     treatment arms: (a) vitamin B complex nutritional supplement and (b) placebo.      The information obtained in this study will help in determining the efficacy of using     nutritional supplements for improving the outcomes of people with depression.   "
123279|NCT01672359|"     A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC     Synergy® and Catalyn® on cognitive and immune function markers and quality of life among     healthy older adults with no history of significant cognitive deficits   "
123280|NCT01672346|"     In this prospective randomized study, we aim to compare the rate of PV reconnection following     PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant PV     conduction will be unmasked by adenosine-provocation.   "
123281|NCT01672333|"     Early stage diagnosis of gastric cancer has ensued different approaches in its resection     strategies. In order to increase the proportion of cases that undergo radical resection and     reduce the recurrence rate, different pre-operative treatments are introduced. Here, the     investigators investigate an active preoperative chemotherapeutic regimen to in patients with     locally advanced gastric cancer.   "
123282|NCT01672320|"     The objectives of this study are to evaluate the clinical value of robotic-assisted total hip     arthroplasty with respect to acetabular cup implantation, and to document the long-term     clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained     at every study site to evaluate the basic clinical outcomes and post-operative component     placement accuracy of each MAKO® THA patient.      The hypothesis is that robotic preparation of the acetabulum will significantly reduce the     variability and inaccuracy in the component alignment parameters that lead to post-operative     complications, including implant failure.   "
123283|NCT01672307|"     The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of     eyebrows.   "
123284|NCT01672294|"     Informal caregivers provide a majority of care for patients during serious illness. Lack of     preparation and completion may leave caregivers less capable of caring for a loved one or     making crucial decisions influencing care.      This study will examine whether a preparation and completion intervention reduces caregiver     anxiety, depression, anticipatory grief, and burden and improves patient quality of life and     health care use.   "
123285|NCT01672281|"     In endurance sports competitions such as cycling, an athlete's capacity to sustain submaximum     power (i.e. endurance capacity) strongly influences overall race performance. Endurance     capacity can be increased by both long, continuous endurance exercise at moderate oxygen     consumption, and high-intensity (at or above peak oxygen consumption) interval training.     However, it has also been shown that resistance exercise, if performed in addition to     endurance exercise, can further enhance endurance capacity. The investigators have recently     described a novel training method, which is based on combined vibration and resistance     training and superimposed vascular occlusion. Based on the investigators previous results     showing that this type of training leads to marked increases in endurance capacity in     previously untrained young women, the investigators aim at investigating whether the method     is also effective in increasing endurance capacity in highly endurance-trained young men, and     whether the method leads to bigger improvements relative to resistance exercise alone.     Besides the functional outcomes the investigators are also interested in the specificity of     the cellular adaptations with respect to the two trainings methods.   "
123286|NCT01672268|"     This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People     with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter     aortic valve implantation (TAVI).   "
123300|NCT01672086|"     The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a     retrospective, multi-center, single-arm study intended to collect data on the survivorship     and long-term safety and effectiveness of the device.   "
123301|NCT01672073|"     The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the     arterial line doesn't significantly attenuate the arterial pressure wave form. The principal     aim of the trial will be:      • To obtain quantitative data allowing investigation of the pressure wave form obtained in a     standard arterial line compared to various arterial lines fitted with the Proxima 3.   "
123287|NCT01672255|"     Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote     weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and     HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by     diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has     demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important     role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly     reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia.     Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal     exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are     demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic     pathways are inhibitory but both single and longer term administration of selective serotonin     reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal     epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS)     activity. What is unknown is whether fluoxetine can also enhance SNS responses and also     override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the     purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS     responses during exercise.   "
123288|NCT01672242|"     Respiratory distress is a common problem in an intensive care unit. There are multiple     mechanisms that are used to help patients who are in respiratory distress including     mechanical ventilation, continuous positive airway pressure (CPAP), bilevel positive airway     pressure (BiPAP), high flow oxygen, and oxygen supplementation through nasal cannula or a     facemask.      The purpose of this study is to evaluate the mechanism by which Vapotherm, a high flow oxygen     system, provides breathing support. Vapotherm provides high flow oxygen at different flow     rates, meaning one can increase the amount of oxygen flow to help with breathing support. The     investigators believe that this high flow oxygen system may provide similar breathing support     that a continuous positive airway pressure machine (CPAP) machine does.   "
123289|NCT01672229|"     This study will investigate whether bortezomib can control the immune system and can be used     to treat GVHD. Bortezomib has been used with not too many serious side effects in patients     with multiple myeloma who will undergo transplant and also for acute graft versus host     disease.   "
123290|NCT01672216|"     Previous studies revealed only a low evidence for the various biofeedback methods and pelvic     floor exercises for treatment of chronic obstipation. The number of randomized controlled     trials is low with in part significant systemic deficiencies. However, the results from the     previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so     promising that a further randomized controlled trial appears useful to demonstrate a higher     degree of evidence. The purpose of this study is to determine whether triple target treatment     (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if     the duration of treatment (3, 6 or 9 months) influence the efficacy.   "
123291|NCT01672203|"     Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased     morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for     development of CTEPH. It is not known, whether the location of pulmonary embolism (central     vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been     performed to assess the CTEPH incidence in different populations: in patients with central     vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.   "
123292|NCT01672190|"     The purpose of this study is to assess the feasibility of recruiting women with urinary     incontinence into a randomized controlled trial of a yoga therapy program.   "
123293|NCT01672177|"     The main aim of the project is to evaluate a self-care intervention program aimed at     enhancing the ability of mildly disabled and healthy older persons in Singapore to manage     their health.      A secondary aim of the study is to evaluate the effectiveness of training community health     workers located within Senior Activity Centres in Singapore to support the self-care capacity     development amongst older persons in the locale.   "
123294|NCT01672164|"     The main focus of this study is to develop blood and/or urine tests that will help to detect     early signs of rejection in people who have had a liver transplant. Researchers will examine     blood, urine, and tissue samples and try to identify markers for certain conditions such as     rejection, response to therapy, and scarring of the liver. Additionally, researchers would     like to identify biomarkers that can detect damage to the native kidneys before blood levels     of creatinine rises. By studying gene expression, researchers hope to be able to diagnose     these conditions earlier and improve liver survival.   "
123295|NCT01672151|"     The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune     Thrombocytopenic Purpura (RITP) and explore the further mechanism.   "
123296|NCT01672138|"     This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal     atrial fibrillation patients using different ablation strategies such as 1) PVAI alone, 2)     PVAI+ CFAE, 3) PVAI+ CFAE+ non-PV trigger ablation.      [ PVAI: Pulmonary Vein Antrum Isolation CFAE: Complex Fractionated Atrial Electrograms Non-PV     triggers: Triggers arising from sites other than pulmonary veins]   "
123297|NCT01672125|"     Lymphedema is one side effect of breast cancer treatment. Measuring the edematous limb     enables monitoring changes in the lymphedema and the effect of treatment. Circumference     measurement using a measuring tape is an inexpensive simple method and therefore useful and     widespread in clinical practice. Circumference measurement performance varies amongst     therapists and lacks uniformity in the literature. To date, the effect of different limb     positions on measurement results has not been examined.      Purpose: The purpose of this study is to describe 1) the effect of position on upper limb     volume measurement by using circumference measurement and 2) to examine whether the     difference between positions are similar in the upper limbs of the same woman, and 3) between     groups of women who are in the intensive phase, in the maintenance phase of lymphedema     treatment and women without lymphedema   "
123315|NCT01671891|"     Rectal cancer is one of the most common malignant tumors in the world. However, there's also     no reliable and sensitive method to monitor diseases and evaluate therapy responses till now.     Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a     promising method in this field. This study is to investigate the role of circulating tumor     cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.   "
123302|NCT01672060|"     Nurse-Family Partnership (NFP) is a primary prevention program that was developed by Dr.     David Olds in the United States (US) with the goal of helping vulnerable young first-time     mothers and their children. The program involves public health nurses (PHNs) visiting mothers     in their homes, providing intensive supports starting in pregnancy and continuing until     children reach their second birthday. Studies in the US have shown that NFP significantly     reduces child maltreatment and child behaviour problems, while also improving children's     early learning and mother's economic self-sufficiency. Economic studies have also shown that     the program pays for itself over the long-term. However, NFP has never been tested in Canada.     Due to major differences in our populations and in our public services, we do not know     whether NFP will show the same benefits here. We therefore plan to conduct a scientific     evaluation of NFP's effectiveness in British Columbia (BC), in close collaboration with the     BC government and BC's Health Authorities. Using randomized-controlled trial methods, NFP's     effectiveness will be specifically evaluated in comparison with existing perinatal services     in BC regarding outcomes across three fundamental domains: 1) pregnancy and birth; 2) child     health and development; and 3) maternal health and life course. Findings from this evaluation     will be used to improve the NFP program — to better meet the needs of vulnerable young     mothers and their children in BC.   "
123303|NCT01672047|"     The investigators hypothesize that the chronic kidney disease patients who suffer from     vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery     calcification and hyperparathyroidism will be improved.   "
123304|NCT01672034|"     The purpose with this study is to investigate whether gastric bypass surgery and the     following weight reduction impact the tone in esophageal sphincters and the esophageal     function.      In a previous study our group used high resolution solid-state manometry to investigate the     pressure in the esophagus and esophageal sphincters in obese patients going through     laparoscopic bariatric surgery. These studies showed that the barrier pressure between the     stomach and esophagus is significantly lower in obese compared to lean patients. In this     study the investigators will examine these patients once more, now after weight reduction to     see whether the barrier pressure is back to normal compared to lean patients.   "
123305|NCT01672021|"     Because MRI can provide increased brain and liver lesion detection as compared with CT, the     investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion     detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation     dose.   "
123306|NCT01672008|"     This study is designed to evaluate the safety, tolerability and efficacy profile of NOX-100     to reduce intradialytic hypotension (IDH) in patients undergoing chronic hemodialysis (HD).   "
123307|NCT01671995|"     This study examines whether a nurse monitored management program at the hospital heart     failure outpatient clinic can improve quality of life in elderly patients with chronic heart     failure, as compared to standard treatment in primary healthcare.   "
123308|NCT01671982|"     To assess the drug concentrations of tenofovir (TDF) in HIV-infected Thai adults with     moderate renal function impairment when administered at the recommended dose of 300 mg every     48 hours, and at an alternative dose of 150 mg every 24 hours.   "
123309|NCT01671969|"     The purpose of this study is to determine whether a very low calorie diet will stabilize or     improve diabetic kidney disease.   "
123310|NCT01671956|"     This is a randomized, double blind, placebo-controlled, parallel group multi-center study in     adult patients with active moderate to severe UC . Eligible patients will be randomly     assigned in a 2:1 ratio to one of two treatment groups, bertilimumab 10 mg/kg or matching     placebo, respectively   "
123311|NCT01671943|"     The purpose of this study is to evaluate the clinical feasibility and safety of the     ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.   "
123312|NCT01671930|"     Introduction      Cardiovascular disease is the leading cause of death in the Western world. The main cause for     cardiovascular events is the development of atherosclerosis in the coronary arteries. In more     than 70% of cases, myocardial infarctions are caused by atherosclerotic plaque rupture, which     results in subsequent formation of an occluding thrombus. Plaques that have a high risk of     rupture are called vulnerable plaques. Cardiovascular imaging provides a complementary     diagnostic approach in the assessment of cardiovascular risk in patients. However, the lack     of biological detection possibilities of current imaging technologies limits their predictive     value. For instance, multi detector computed tomography (MDCT) is an excellent tool to     visualize coronary atherosclerosis. However, individual risk assessment is still problematic.     Which of the diagnosed atherosclerotic plaques will undergo plaque rupture and lead to acute     vascular events is currently hard to predict. Potentially, serum biomarkers could help     identify the patient at risk. A wide variety of prognostic markers related to atherosclerosis     have been identified in the past to predict for cardiovascular events. Nevertheless, their     predictive value in individual patients is still limited. A difficulty in serum biomarker     research is the requirement of large patient cohorts to study the relation between event rate     and serum biomarker levels. The necessity to perform lengthy and costly studies, hinders the     translation of novel cardiovascular serum biomarkers into the clinic. An alternative approach     could be to study the correlation between levels of serum biomarkers and the presence of     atherosclerosis in the coronary arteries.      Study objectives      Primary objective of the present analysis is to investigate the predictive value of a variety     of serum biomarkers to predict atherosclerosis in the coronary tree of patients undergoing     cardiac MDCT.      Design and Methods      Patients undergoing cardiac MDCT are eligible for the study. Excluded are patients with acute     coronary syndrome, hemodynamic instability, pregnancy, severe renal insufficiency, allergy     for contrast medium and inability to obtain informed consent. Permission to store the serum     samples for future analysis of new prognostic markers for cardiovascular events will be     acquired from the patients. Written information is send to the patient at least 1 week prior     to CT. The samples will be stored coded, at the Biobank Maastricht, for a maximum duration of     15 years. Once measurements from the samples will be performed, the serum samples will be     sent by the Biobank coded to the analyzing researchers, which have no access to the key file     where codes are linked to the specific hospital identity number. This file will be stored by     an independent researcher at the Cardiology department of the Maastricht University Medical     Center. The assessment of atherosclerotic burden of the coronary tree will be performed by     cardiac MDCT specialists blinded to the clinical data and serum biomarker outcome. Biomarker     levels are correlated to the severity and amount of coronary artery disease as assessed by     cardiac MDCT.   "
123313|NCT01671917|"     The purpose of this study is to determine whether a standardized education and exercise     program proposed before a total knee replacement for knee osteoarthritis is effective in     functional recovery after surgery.   "
123314|NCT01671904|"     This multi-center, open-label, dose-finding study will evaluate the safety and     pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with     bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to     participants with relapsed/refractory or previously untreated CLL. The study will explore two     schedules for drug administration, Schedule A (venetoclax introduced before other agents) and     Schedule B (introduced after other agents). In addition, the study will explore two     venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional).     The study is comprised of two stages for each participant population: a dose-finding stage     and a safety-expansion stage. The dose-finding stage will explore multiple doses of     venetoclax to be used in combination with fixed doses of BR or BG.   "
123318|NCT01671852|"     Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep     characterized by prolonged partial upper airway obstruction and/or intermittent complete     obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition     occurs in 2-5% of children and can occur at any age, but it is most common in children     between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease,     growth delay, poor learning and behavioral problems such as inattention and hyperactivity.     The most common underlying risk factor for the development of OSA is enlargement of tonsils     and adenoids. Given the potential risk of complications associated with surgery of the     tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been     considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent     Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to     moderate OSA4. The authors recommended that further randomised controlled studies were     required to evaluate the efficacy of INCSs in children with OSA. In particular they     recommended that future studies should employ sleep studies to look for any improvement with     INCSs, and should include children with more severe OSA, as these are the patients at the     greatest risk of complications of surgery and would benefit most from a non-surgical     treatment. The purpose of this study is therefore to explore the efficacy of INCSs in     children with the full spectrum of OSA severity, including sleep study analysis., and longer     term follow-up.   "
123319|NCT01671839|"     The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System     for the improvement in the appearance of cellulite.   "
123320|NCT01671826|"     Autologous stem cell transplantation remains the gold standard of treatment for newly     diagnosed patients under the age of 65. Even though it is also regularly performed above the     age of 65, there are very few data in this patient population. The investigators will capture     safety and efficacy data in that setting.   "
123321|NCT01671813|"     The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in     patients with a certain type of large B-Cell Lymphoma. The side effects (unwanted effects) of     SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied. It     is not known if brentuximab vedotin is better or worse than other treatment that might be     given.   "
123322|NCT01671800|"     The objective of this study is to determine if Myobloc significantly decreases     prosthesis-associated symptomatic sweating in amputees when compared to a saline solution     placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a     total enrollment of 32 amputee subjects.   "
123323|NCT01671787|"     This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil     fumarate (TDF).   "
123324|NCT01671774|"     The purpose of the trial is to assess the immunological effects and their kinetics, the     safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of     Interleukin-2 in subjects with advanced gastroesophageal cancer.   "
123325|NCT01671761|"     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in     two age groups: adolescents and young adults.   "
123326|NCT01671748|"     Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard     treatment in the UK for patients with VLUs is compression bandaging or stockings. The MIST     ultrasound system is a noncontact device which delivers low frequency ultrasound through a     gentle saline mist directed at a patient's wound. This study aims to determine whether the     use of the MIST device used in combination with standard treatments can improve healing of     VLUs compared to UK standard practice. This will be assessed by measuring any reduction in     wound size in the two groups after receiving 8 weeks of either Standard Care once a week or     MIST combined with Standard Care three times a week.   "
123327|NCT01671735|"     This study will collect baseline survey data from a NCP funded VA Diabetes Prevention Program     (VA DPP) clinical demonstration program at three medical centers on VA DPP participants and     VA DPP-eligible VA MOVE! participants to identify baseline participant demographic     characteristics; attitudes and beliefs about diet, exercise and weight loss, and psychosocial     constructs such as social support; and self-regulation skills that predict 6-month weight     loss and program attendance. The data collected will contribute to our knowledge of     pre-diabetic Veterans' attitudes and beliefs about diet, exercise and weight loss, to our     understanding of how different programs may impact weight loss, and to evidence-based     targeting in future clinical implementation projects. It will also provide baseline quality     of life data for use in a future cost-effectiveness analysis.   "
123328|NCT01671722|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
123329|NCT01671709|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single     dose, crossover, oral bioequivalence study.   "
123330|NCT01671696|"     The main hypothesis being tested is that imaging and serologic biomarkers of apoptosis and     progressive extracellular matrix remodeling will precede echocardiographic indices of     systolic and diastolic function among childhood cancer survivors treated with anthracyclines     thus allowing evaluation of new therapies to prevent and manage heart failure in these     patients.   "
123331|NCT01671683|"     The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant     chemotherapy with capecitabine during the resting periods in patients with locally advanced     rectal cancer.   "
123332|NCT01671670|"     Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia      Design:        -  A single blind randomized controlled trial        -  200 participants will be included        -  Two arms: acupuncture and sham acupuncture group   "
123333|NCT01671657|"     The purpose of this clinical investigation is to gather data to evaluate the impact of using     Eeva with traditional morphology grading on implantation rates.   "
123334|NCT01671644|"     The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva     with traditional morphology grading on clinical pregnancy rates.   "
123336|NCT01671618|"     The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound     (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending     aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the     measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal     disease.   "
123339|NCT01671579|"     To establish the accuracy of bowel ultrasound in the follow-up of known (previously     diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance     imaging technology used to obtain detailed images of the small bowel) as the reference     standard.   "
123340|NCT01671566|"     Adults with congenital heart disease have various degrees of impaired exercise capacity     compared to healthy controls. Impaired exercise capacity makes everyday activities more     difficult and demanding. There are few studies on effect of exercise training in adults with     congenital heart disease. The hypothesis of this study is that structured home based exercise     training will improve exercise capacity and health status in the studied population.   "
123341|NCT01671553|"     Background The home is the primary source of SHS exposure. The scientific evidence shows that     there is no risk-free level of exposure to SHS that stop smoking is the sole way to     completely eliminate the risk of SHS exposure. Although research studies indicated that     smoking bans in restaurants, bars, and workplaces can significantly reduce the level of SHS     exposure, governments lack the authority to restrict smoking in homes. Therefore, parental     cessation is a more effective means to reduce the SHS exposure.      Aim The aims are (1) to promote smoking cessation in the community and (2) assess the effect     of different smoking cessation approaches through the Smoke-free Teen Contest. The specific     objectives of the study are to test the effectiveness of different smoking cessation     approaches on quit rate and change in smoking behaviours among smokers who are referred by     Hong Kong Council on Smoking and Health (COSH).      Methods The referred smokers were nominated by primary 1 to secondary 3 students who joined     the Smoke-free Teen Contest organized by COSH. Two domains of outcome will be assessed: (1)     the primary outcome is the self-reported 7-day point prevalence (pp) quit rate at 6 months     and (2)the secondary outcomes included (i) biochemical validated quit rate at 6 months and     (ii) rate of smoking reduction by at least of half and (iii) number of quit attempts at 6     months.      Procedure Smokers, who are referred by the Hong Kong Council on Smoking and Health (COSH),     were nominated by primary 1 to secondary 3 students joined Smoke-free Teen Contest organized     by COSH. Those smokers will be randomized into two groups (Intervention group and Control     group) using the clustered randomization method by school. After the clustered randomization,     the oral consent of eligible subjects were obtained to the study through telephone interview.     Intervention group will receive 1,2,3, 8-week and 6-month telephone follow-up after baseline,     while control group will only receive 6-month telephone follow-up after baseline. Those     participants who reported to have stopped smoking will be invited for biochemical validation     of smoking status at 6-month follow-up.      Hypothesis We hypothesize that the intensive telephone counselling plus NRT treatment will     lead to significant increases in rates of smoking cessation in the intervention groups than     the control group.   "
123342|NCT01671540|"     In this study the invetigators seek an answer on the following hypothesis:        -  What are the long term effects of an IPV treatment evaluated with classical outcome          parameters? (FEV1, Raw)        -  Is the possible effect noticeable on the novel technique and is this comparable with the          classical outcome parameters?   "
123343|NCT01671527|"     The purpose of this research study is to determine the physical brain changes in people with     cervical dystonia after deep brain stimulation (DBS) surgery and as compared to healthy     controls. We will do this by measuring your body's response to transcranial magnetic     stimulation (TMS) before and/or after DBS surgery.      TMS is a non-invasive procedure during which you sit in a chair that looks like one you would     find at the dentist's office. A nerve stimulator is placed on the wrist of the right hand to     stimulate the median nerve; the intensity of the nerve stimulator is gradually increased     until the right thumb begins to twitch. A magnetic coil is placed on the scalp on one side of     the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles     in the opposite hand.      If you are a control subject, and therefore will not/have not have DBS surgery, we will     measure the body's response to TMS for comparison purposes. We expect that the electrical     differences in the brain may be related to the physical benefits some patients with primary     cervical dystonia receive from DBS surgery.   "
123344|NCT01671514|"     The major goal of this study is to characterize the ability of dark chocolate enriched in     epicatechin (a component of dark chocolate) to improve the structural and functional features     of mitochondria in two groups        1. Patients with heart failure (HF) and type 2 diabetes (DM2) and        2. Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed          by VO2 max)      We propose that a 3 month treatment with dark chocolate will lead to a significant     improvement in exercise capacity which will be secondary to the improvement in skeletal     muscle structure from epicatechin.   "
123345|NCT01671501|"     This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol     screen; and examines innovative behavioral interventions, and their cost effectiveness, for     hazardous drinking within a large HIV primary care clinic. We will compare Motivational     Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the     interventions on hazardous drinking, enrollment in substance use treatment programs, and HIV     outcomes including antiretroviral therapy adherence, HIV RNA control, and unsafe sex. Given     the well-known adverse effects of hazardous drinking on HIV care and outcomes, the proposed     study has the potential to make a significant impact in the care of HIV patients.   "
123346|NCT01671488|"     The main purpose of this study is to study the safety and effectiveness of ADXS11-001 when     combined with standard chemotherapy and radiation treatment for anal cancer. ADXS11-001 is an     investigational agent that is not approved by the FDA to treat anal cancer or any other     cancer.   "
123370|NCT01671163|"     The purpose of this research study is to evaluate placing the radiation therapy markers     (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic     Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the     end. The ultrasound will allow the doctor's to see where the radiation therapy markers     (Fiducial) is to be placed as outlined by the Radiation Oncologist.   "
123347|NCT01671475|"     The proposed study aims to test the impact of microEEG on clinical management (diagnosis and     treatment) of emergency department patients with Altered Mental Status (AMS). The study will     utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients     will be randomized to routine care plus microEEG (experimental arm) or routine care alone     (control arm). The investigators hypothesize that incorporating microEEG in the work up of     patients with AMS will impact the clinical management of these patients.   "
123348|NCT01671462|"     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human     Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV     diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or     residual) and a BD cervical brush in BD transport medium to reference histology results from     biopsy.   "
123349|NCT01671449|"     A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly)     versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric     cancer   "
123358|NCT01671332|"     The overall purpose of the study is to determine whether or not the inclusion of suramin to     standard treatment with docetaxel improves progression-free survival for patients with     advanced non-small cell lung cancer in the second and third line settings.   "
123350|NCT01671436|"     Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition. However,     currently available treatment options have limited efficacy. The aim of this pilot study is     to determine whether patients suffering from MDD who have not responded to at least one     antidepressant trial may actively engage in a novel group therapy, Central Meditation and     Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT     techniques may have benefit for major depression. The purpose of this trial is to assess the     feasibility of a group form of CMIT for the treatment of major depression. The trial will     also seek to identify neurophysiological and cardiovascular predictors of treatment response.      In this study, 10 subjects with major depressive disorder will receive antidepressant     treatment augmentation with group meditation and mental imagery therapy for a total of 12     weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic     stretches. The subjects will be limited to those who remain depressed despite at least one     trial of antidepressant medication. Changes in brain activity and heart rate variability will     be measured at three time points utilizing electroencephalography (EEG) and pulse monitors.     Depression symptoms will be measured at several time points using questionnaires and     objective measures. Participation will require a total of 15 visits for weekly therapy and     the measurements. Two-month follow-up questionnaires will be mailed to the subjects after     study end to assess durability of any improvements in depressive symptoms.   "
123351|NCT01671423|"     Cellulitis is the medical term for an infection of the skin, with symptoms including redness,     swelling, warmth, and pain. This group of symptoms is called inflammation, and is caused by     the body's immune system responding to the infection. Standard care for cellulitis is using     antibiotics to destroy the infection, but the inflammation can persist and cause a great deal     of pain. The hypothesis of this study is that adding a single dose of an oral steroid     (prednisone), which tempers the immune response, will reduce inflammation, reduce pain, and     speed recovery. This hypothesis will be examined by recruiting a group of patients with     cellulitis, and randomizing them to two sub-groups: one group will receive a dose of     prednisone, while the other group will receive a placebo. Neither group will know what they     received unless there is a problem. These subjects will be followed up at the 48 hour mark     and the 7 day mark, and will have their results compared.   "
123352|NCT01671410|"     The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after     utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS.     This trial will investigate the safety and tolerability of sublingual buprenorphine in     infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in     those who are breastfeeding.   "
123353|NCT01671397|"     The prevalence of obesity has steadily increased in the United States. This can lead to the     worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and     osteoarthritis. The medical management of obesity involves dietary counseling and education,     behavioral counseling with goal setting, and exercise. Patients with short sleep periods in     the range of 5 to 7 hours per night are often heavier than normal sleepers even after     controlling for other factors. We hypothesize that the addition of focused counseling on     healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help     women lose weight.   "
123354|NCT01671384|"     Spinal muscular atrophy (SMA), an autosomal recessive disorder, is characterized by muscle     weakness due to degeneration of anterior horn cells in the spinal cord and brain stem nuclei.     It has a variable incidence of 1 in 6700 to 1 in 25000 live births and prevalence of 0.12 to     25 per 10,000 populations in different geographic areas and genetic constitution. A     homozygous deletion/mutation involving exon 7 in SMN1 (survival motor neuron 1) is present in     around 95% of the cases, resulting in the biochemical deficiency of the SMN protein. A     genomic duplication at the same locus produces nearly identical SMN2 (survival motor neuron     2) that differs from SMN1 by a nucleotide substitution that promotes exon 7 exclusion thus     giving rise to only a fraction of the full length protein. Phenotypic variation in SMA     correlates with the number of SMN2 gene copies and the level of SMN protein in cells.      Several hypotheses including defective inhibition of apoptosis, glutamate excitotoxicity and     lack of a neurotrophic factor(s) in nerve or muscle have been speculated in the pathogenesis     of SMA.      Valproic acid (VPA), a histone deacetylase (HDAC) inhibitor, directly increases SMN     expression in SMA patient-derived cell lines in vitro. Till date 3 open label trials and 1     placebo controlled RCT of VPA in human subjects have been published, all indicating a     possible benefit in strength and/or motor function. Till date there is no effective therapy     for SMA. Therapy is mainly supportive and palliative which can prolong lifespan and prevent     complications to some extent without actually curing the disease.      Children with SMA may have a reduced capacity to synthesis carnitine consequent to     significantly diminished skeletal muscle mass. VPA independently inhibits carnitine transport     and its metabolites deplete carnitine levels by binding to them. So along with valproate     these patients should be supplemented with carnitine.      With this background the investigators have planned a double blind randomized placebo     controlled trial of Valproate and levocarnitine in 60 children (30 each in intervention and     control arm) with Spinal Muscular Atrophy aged 2-15 years over a 2 year period with one     baseline and four follow up visits. The study will be conducted in the Department of     Pediatrics, AIIMS at the Myopathy clinic.   "
123355|NCT01671371|"     The purpose of this study is to determine whether point-of-care (bedside) ultrasound assists     physicians in the evaluation and management of patients with syncope.   "
123356|NCT01671358|"     This study is to determine if medication cabinets located outside of isolation rooms in     hospitals and their contents, particularly medications and the delivery folders are at a     higher risk of having harmful bacteria on them.   "
137938|NCT01479257|"     The goal of this research study is to learn how cultural, environmental, and interpersonal     experiences, as well as personal thoughts and feelings, influence cancer risk behaviors among     Latino residents of Houston, Texas.   "
123357|NCT01671345|"     Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the     prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in     the VA is higher among racial and ethnic minorities. Poorly controlled diabetes leads to a     number of complications including cardiovascular disease, blindness, amputation, and end     stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as     diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care     is related at least in part to effective communication in medical encounters. This project is     designed to test a video intervention to improve patients' communication behaviors. Doctors     will also receive a communication skills training program. The project will assess the impact     of the training programs on communication and outcomes. The study is designed to help make     patient care more patient-centered, which is one of the six aims for improvement in the IOM     Report, Crossing the Quality Chasm and is a goal of VA transformation efforts.   "
123360|NCT01671306|"     Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral     development in non-diabetic patients with stable coronary artery disease. Our aim in this     study is to find out any possible relationship between the levels of circulating monocyte     subsets and coronary collateral development in type 2 diabetic patients.   "
123361|NCT01671293|"     The purpose of this study is to determine whether a multi-component remote care model     (telephone-based) is effective to achieve the modification of unhealthy eating practices and     increase physical activity in adults who have prediabetes and over-weight/obesity. The     effectiveness of the remote care model will be determined with respect to the mentioned     practices as well as anthropometric parameters (Waist circumference and Weight) and clinical     parameters (Fasting Glucose, Triglycerides, Total Cholesterol) which are sensitive to changes     in these habits. The counseling intervention is the core of the multi-component tele-care     model, which also includes counseling-through text messages, supply of Educational material     and self-monitoring equipment (pedometers and measuring tape for patients to check their     waist circumference).   "
123362|NCT01671280|"     To collect the efficacy and safety information of Azithromycin IV related to their     appropriate use in daily practice   "
123363|NCT01671267|"     The prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers,     allegedly due to the substantial load of these body regions during work. Work disability is a     common consequence of these pains. Lowering the physical exposure through ergonomic     intervention may be a strategy to reduce the workload. An alternative strategy could be to     increase the physical capacity through strength training of the shoulder-, arm- and     hand-muscles. This study investigates the effect of two contrasting interventions, i.e. load     reduction (ergonomic intervention) versus training of physical capacity (strength training)     on pain and work disability in slaughterhouse workers.      The main hypothesis is that strength training intervention for 10 weeks compared with     ergonomic intervention results in reduced pain of the shoulder, arm and hand.   "
123364|NCT01671254|"     The purpose of this 8-week intervention trial is to investigate the effect of a dietary     supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in     healthy hyperlipidemic subjects   "
123365|NCT01671241|"     Hypothermia after delivery is a world-wide problem associated with morbidity and mortality.     The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is     unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin     wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very     preterm babies and represents the standard of care recommended by the International     Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce     heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the     proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped group     (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The     combination of body and head protection with a polyethylene wrap needs to be evaluated     further. The investigators conducted a prospective, randomized, controlled trial in very     preterm infants to evaluate whether a polyethylene total body wrapping (body plus head)     prevents heat loss after delivery better than polyethylene occlusive wrapping.   "
123366|NCT01671228|"     The purpose of this research is to develop a patient decision aid in paper and web formats to     help patients with chronic kidney disease make informed dialysis treatment decisions.   "
123367|NCT01671215|"     fibroids are common among women in fertile age. the relation between fibroids and infertility     is controversial. our goal is to claculate a ratio between uterine cavity - endometrium &     myometrium in normal uterine s and study the interference of the cavity in uterine s with     fibroids.   "
123368|NCT01671189|"     Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation     tool to automate appointment confirmation and rescheduling. Working in parallel with the San     Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will     automate reminders that request text responses from patients to either confirm or request to     reschedule their upcoming appointments. While simple in concept, this tool aims to free up     scarce clinical resources which are currently allocated to daily patient phone call     reminders. With funding from a Bay Area foundation, the investigators will develop and pilot     this open-source software tool in a 12-month randomized-controlled trial, slated to begin in     October 2012. The endpoints of the study will aim to demonstrate improvements in both     appointment adherence and glycemic control.   "
123369|NCT01671176|"     To assess implant stability, implant loss, adverse skin reactions, and Quality of Life     Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to     determine the feasibility of fitting the sound processor 3 weeks after surgical implantation,     and to investigate if the type of skin reactions following implantation could be related to     the demographic data of subjects and the type of surgical technique used   "
123371|NCT01671150|"     Depressive disorders occur at a high rate in patients with inflammatory disorders, with a     point prevalence of 15-29%, which is two to three times greater than that observed in the     general population. Substantial evidence has shown that inflammation and increases in     proinflammatory cytokine activity play a critical role in the onset and perpetuation of     depression and depressive symptoms (e.g. insomnia, fatigue) in those who are co-morbid for     inflammatory disorders. Consistent with this, experimental work has shown that an     inflammatory challenge can increase depressed mood in an otherwise healthy sample. Based on     these findings, there has been a growing interest in whether inflammatory processes can     contribute to depression in a causal manner and how these effects might occur.      Given the observation that inflammatory processes trigger social withdrawal, coupled with     evidence that feelings of 'social disconnection' play a critical role in the onset and     perpetuation of (non-inflammatory forms of) depression, it is surprising that the social     psychological consequences of inflammation and their contribution to depression have not been     more fully explored. Here, we suggest that inflammation may increase feelings of social     disconnection and that these social psychological changes may be an important contributor to     inflammation-associated depression. Indeed, preliminary data demonstrated that an     experimentally-induced inflammatory challenge (endotoxin) led to increases in self-reported     feelings of social disconnection (e.g., I feel disconnected from others) in addition to     increases in depressed mood. Aside from these findings, however, there are no studies that     have explored the effect of inflammatory processes on social experience in humans. The     over-arching objective of this proposal is to explore the experiential and neural correlates     of inflammatory-induced changes in social experience (e.g., feelings of social     disconnection), which may provide a critical missing link in understanding the relationship     between inflammation and depression.      Participants (n=100) will be randomly assigned to receive either endotoxin or placebo and     will then be monitored for the next six hours. Blood draws to assess cytokine levels as well     as self-reported feelings of social disconnection and depressed mood will be collected     hourly. In addition, at the time of peak cytokine response, participants will complete a     neuroimaging session to examine the effect of inflammatory challenge on neural sensitivity to     social rejection and social acceptance. It is hypothesized that endotoxin will increase     feelings of social disconnection over time, and that the underlying neural sensitivities that     give rise to these feelings (e.g., increased neural sensitivity to social rejection;     decreased neural sensitivity to social acceptance) will contribute to inflammatory-induced     depressed mood.   "
123372|NCT01671137|"     The present study has several aims:        1. Establish whether Lactobacillus Rhamnosus Strain GG is able to prevent the onset of IBS          in a high risk group of children enrolled after an acute gastroenteritis (the study has          been powered to this aim).        2. Establish whether Lactobacillus Rhamnosus Strain GG is able to stabilize the intestinal          microbiota after an acute gastroenteritis.        3. Define the intestinal microbiota of children following an acute gastroenteritis and          identify, if possible, a modification of the microbiota that can predict the emergence          of Irritable Bowel Syndrome.   "
123373|NCT01671124|"     Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang     supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia     divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of     attenuating the occurrence of depression. The study will enroll 100 patients who meet the     inclusion and exclusion criteria. The trial will be concluded when a total of evaluable 80     patients (40 patients in each treatment group).   "
123374|NCT01671111|"     The purpose of this extension study is to evaluate SSP-004184AQ in patients with     transfusional iron overload and to provide data on long term safety and efficacy.      SSP-004184AQ is an iron chelator under development for chronic daily oral administration to     patients with transfusional iron overload   "
123375|NCT01671098|"     Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal     interface that represents a collection of airfoils creating an aerodynamic structure. The     airflow during respiration generates positive and negative pressures that power the gas     exchange between the sinuses and the nose. Major surgical alteration of the interface reduces     the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the     natural anatomy, topography and aerodynamic configuration of the interface will have     negligible effects on sinonasal gas exchange.   "
123376|NCT01671085|"     This is a study in healthy participants with high levels of bad cholesterol who are already     taking a popular type of cholesterol-lowering medication called statins. Following multiple     doses of LY3015014, investigators will study the safety and tolerability of the drug, how the     body handles the drug, and the drug's effect on the body. Participants will remain in the     study for about 3 months, not including screening. Screening is required within 28 days     before the study starts.   "
123377|NCT01671072|"     The purpose of this study is to determine whether TissueGene-C, an allogeneic human     chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients     with degenerative arthritis   "
123378|NCT01671059|"     This non-interventional study evaluated the use and efficacy of tocilizumab     (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible     participants initiated on tocilizumab treatment according to the approved label were followed     for 6 months.   "
123379|NCT01671046|"     This multi-center, prospective observational study will evaluate the correlation of liver     biopsy and transient elastography in liver fibrosis assessment in patients with chronic     hepatitis C. Data will be collected for 96 weeks.   "
123380|NCT01671033|"     From the scarce literature it showed that computer/internet-aided cognitive behavior therapy     (CBT) was superior to waitlist and placebo assignment across outcome measures, and the     effects of computer/internet-aided CBT were equal to therapist-delivered treatment across     anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based     relaxation with biofeedback treatment for panic disorder.   "
123381|NCT01671020|"     Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and     single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb®     tablet (fimasartan) in healthy subjects   "
123382|NCT01671007|"     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at     risk for stroke are enrolled to characterize the target population and to collect real world     data on important outcome events. For administrative purposes the study is divided into two     protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area)     countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in     both protocols is estimated to be 48,000 patients, and all these patients will be included in     the data analysis for study 1160.129.   "
123383|NCT01670994|"     This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801     in patients who have relapsed or refractory multiple myeloma.   "
123384|NCT01670981|"     This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T     compared to placebo (vehicle control) when administered via transendocardial catheter-based     injections to patients with end stage heart failure due to IDCM, who have no reasonable     revascularization options (either surgical or percutaneous interventional) likely to provide     clinical benefit.   "
123398|NCT01670799|"     The purpose of this study is to evaluate the anti-cancer effect of a pain medication called     ketorolac (Toradol) on ovarian cancer cells in the abdominal (peritoneal) cavity after     surgery for ovarian, fallopian tube or primary peritoneal cancer.   "
123385|NCT01670968|"     Primary Objective:      To examine changes in expression of genes [particularly ABCA1 and SREBP2] involved in reverse     cholesterol transport (RCT) in monocytes from HIV-infected subjects starting antiretroviral     therapy and the different effect of NNRTI and PI based regimens      Secondary Objective:      To examine changes in monocyte intracellular cholesterol content in HIV-infected subjects     starting antiretroviral therapy and the different effect of NNRTI and PI based regimens   "
123386|NCT01670955|"     PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT     OF ANAEMIA IN GYNAECOLOGICAL PATIENTS   "
123387|NCT01670942|"     The purpose of this research is to see if people who have had a collapsed lung that has been     re-expanded can be safely taken to an elevation that a person might experience while in a     commercial airplane without having their lung partially collapse again, or have any symptoms     such as feeling short of breath or having oxygen levels in the blood decrease while at the     simulated altitude.      The investigators hypothesize that subjects who have had a collapsed lung that has been     re-expanded will not have any adverse symptoms or signs while subjected to a simulated     altitude of 8400 feet (565mm Hg) or 12650 ft (471mm Hg).   "
123388|NCT01670929|"     In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice     daily), started soon as possible at luteal phase and after a positive pregnancy test and     continued to 28 weeks of gestation, compared to placebo, ).   "
123389|NCT01670916|"     Probiotics is given routinely to infants admitted to the department of neonatology during the     first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence     of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical     records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1     March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009     will be compared.   "
123390|NCT01670903|"     Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the     aortic wall. The natural history of AAA is gradual expansion and if left untreated may result     in rupture and death. The mechanism of the development of this disease is unknown however it     appears to be multifactorial and possibly related to degradation processes within the     arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have     an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting     degeneration of the vessel wall.      Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive     patients, and are associated with a lower rate of aortic expansion compared to other     antihypertensive drugs.   "
123391|NCT01670890|"     Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant     gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ.     Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment     procedure has not been established yet.      The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of     TMZ and CDDP in patients with recurrent malignant gliomas   "
123392|NCT01670877|"     This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how     HER2 mutated cancer responds to treatment with neratinib.   "
123393|NCT01670864|"     Background According to the report of Census & Statistics Department, there are still 659,300     daily smokers (11.1%) in Hong Kong and smoking kills over 7,000 people per year. The Quit and     Win programme provided another opportunity to reach large group of smokers, and it aims to     widespread quit attempts among smokers via incentives in order to boost up the number of     quitters. Although such competitions appear to reach large cohorts of smokers, there is still     insufficient evidence of its effectiveness in helping smokers to achieve complete cessation.      Aim This project aims to promote and evaluate community-based smoking cessation services     through the Quit to Win Contest organised in the 18 districts of Hong Kong. The specific     objectives of the study are (1) to build capacity in the community on smoking cessation     through a training programme; (2) to empower the participated NGOs (a) to raise the awareness     of smoking cessation in the community level; (b) to reach as many smokers as possible; (c) to     arouse the interest of smokers to quit, through organizing the Quit to Win Contest; (3) to     test the effectiveness of community-based on-site face-to-face counselling and Short Message     Service (SMS) message vs. self-help booklet to assist current smokers to quit smoking; and     (4) to build-up a community-based participatory research (CBPR) model in smoking cessation     intervention at a district level in Hong Kong.      Methods A community-based participatory (CBP) approach, which is an effective way to engage     public health researchers and community members (NGOs, other major stakeholders, and     participants), will be used. Two domains of outcome will be assessed: (1) Effectiveness of     smoking cessation interventions, (2) process evaluation of the recruitment activities     including number of eligible participants and amount of publicity.      Procedure At the recruitment sites, after screening for eligibility of participants for the     Quit to Win Contest, smoking counselor will measure eligible participant's level of carbon     monoxide (CO) on expired air, and provide the self-help smoking cessation materials developed     by the Hong Kong Council on Smoking and Health (COSH). Then the counselor will explain and     invite the participants to join the cluster randomized controlled trial on smoking cessation     intervention. Participants will be allocated to one of the groups of the smoking cessation     intervention. 3- and 6-month follow-ups will be conducted      Hypothesis We hypothesize that the on-site brief smoking cessation advice will lead to     significant increases in rates of smoking cessation in the intervention group than the     control group (with the self-help materials only). Another hypothesis to be tested is that     the intervention of sending SMS messages of smoking cessation advice is effective to increase     the quit rate comparing to the control group.   "
123394|NCT01670851|"     This is a prospective, multicenter, single arm, observational pilot study to assess the     clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction     following eLAPE and simultaneous stoma reinforcement.   "
123395|NCT01670838|"     This is a prospective cohort study investigating cardiac function and cardiac biomarkers in     patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to     document the incidence of myocardial dysfunction,to find the predictive factors of myocardial     dysfunction, describe heart rate variability and to assess the impact of all cardiac problems     on morbidity and mortality.   "
123396|NCT01670825|"     The aim of this study is to determine whether pulsed radiofrequency or steroids are better     for occipital neuralgia. Seventy-six patients with ON or migraine with tenderness over the     occipital nerve who respond to occipital nerve blocks (hereafter included under the broad     category ON) will be randomized in a 1:1 ratio to receive either corticosteroid and local     anesthetic injections (n=38) or local anesthetic and PRF of the occipital nerve(s) (n=38) for     occipital neuralgia. Both patients and the treating & evaluating physicians will be blinded.     The first follow-up visit will be at 6 weeks. Patients who obtain significant pain relief     will remain in the study. Those patients who fail to obtain any benefit will exit the study     and be allowed to crossover to the other treatments or receive alternative care. The second     follow-up will be at 3 months and the final follow-up will be at 6-months post-procedure.   "
123397|NCT01670812|"     The purpose of this study is to investigate efficacy and safety of fresh frozen plasma(FFP),     high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic     leukemia.   "
123399|NCT01670786|"     Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural     effusion, with minimal adverse events, especially reducing dose.   "
123401|NCT01670760|"     The core temperature of the body normally decreases in response to anesthesia. Deep tissue     temperature can be used to estimate of body core temperature. Deep tissue temperature of the     forehead will be measured using a new technology known as zero-heat-flux thermometry. The     usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal     temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously     during surgery and compared for agreement. The hypothesis of this trial is that deep tissue     temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal     temperatures during surgery.   "
123402|NCT01670747|"     In this study gas-exchange and respiratory mechanics variations to PEEP change will be     correlated to CT lung morphological modifications assessed at different airway pressures (5,     15, 30 and 45 cmH2O).   "
123493|NCT01669577|"     Prospective observational trial searching for independent predictors of mortality. Data was     collected at trauma scene, ER, three and 24 hours of hospital stay.The patients will be     followed for 30 days after hospital admission.   "
123403|NCT01670734|"     Primary Objective:      Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab     SAR236553 (REGN727).      Secondary Objectives:        -  Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with          mild and moderate hepatic impairment and in matched subjects with normal hepatic          function.        -  Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with          hepatic impairment and in matched subjects with normal hepatic function.   "
123404|NCT01670721|"     Primary Objective:      To evaluate the safety of aflibercept in participants with mCRC treated with     irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based     regimen (participants similar to those evaluated in the VELOUR trial [EFC10262, NCT00561470])     according to side effects prevention and management guidelines.      Secondary Objective:      To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant     population.   "
123405|NCT01670708|"     The purpose of the Multisite Evaluation of the Honest Opportunity Probation with Enforcement     Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control     trial (RCT) replication of the original Hawaii HOPE program and evaluation. The HOPE program     provides strict oversight of probationers through a HOPE Court judge and intensive probation     supervision, including random drug testing, coupled with swift and certain sanctions in     response to positive results on random drug tests and other violations of conditions of     supervision. The HOPE DFE Evaluation is being conducted among probation populations in four     sites and will identify the effectiveness of swift and certain sanctions on targeted     outcomes, both primary (appointment no-shows, positive urine tests, re-arrest rates) and     secondary (revocation rates, jail days served, prison days sentenced).   "
123406|NCT01670695|"     This is an cohort study to investigate the disease course and treatment response of patients     with IgG4-related disease.   "
123407|NCT01670682|"     Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous     fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh     are both developed in China for vaginal apex fixation, the former is native tissue repairs,     and the latter is augmentation with mesh.      This study is designed to determine the effectiveness and safety of ischia spinous fascia     fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh     for the treatment of pelvic organ prolapse stage III.      Patients enrolled into the study will be followed up for up to 3 years after surgery.     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before     and after surgery, patient satisfaction through quality of life and sexual function     questionnaires before and after surgery, and peri-operative complication rates will be     evaluated.   "
123408|NCT01670669|"     The purpose of this study is characterize the efficacy, safety, tolerability, and     steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a     solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal     retention (FFR) for 8 weeks.      Hypothesis:      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the     adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the     adult profile.   "
123409|NCT01670656|"     The study investigates four vaginal ring groups with respect to relief of primary     dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant     treatment efficacy in relief of primary dysmenorrhea.   "
123410|NCT01670643|"     The most common goal for patients with vision loss who present for vision rehabilitation is     to be able to read. The video magnifier (a device which combines a video camera and a screen     to view the print being magnified) is the device which most often allows low-vision     individuals to read successfully for extended periods of time. Previous studies on the     outcomes of vision rehabilitation have not identified which components of the vision     rehabilitation are effective. The hypothesis of this project is that providing a video camera     magnifier, with basic training in operating the device, will allow patients to enhance both     objective reading ability and subjective report of reading competence.   "
123411|NCT01670630|"     The purpose of this study is to estimate if a novel sheathed speculum provides improved     visualization of the cervix compared to a standard (non sheathed) speculum, and to estimate     if the sheathed speculum causes less discomfort during the examination.   "
123412|NCT01670617|"     The purpose of this study is to evaluate the long-term relief of pain and return to function     for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed     product and has been used in more than 7,500 patients over the last 7 years.   "
123413|NCT01670604|"     This study compares the effect of infusion of two types of modern hydroxyethyl starch on the     renal function and acid-base in patients undergoing urologic surgery.   "
123414|NCT01670591|"     Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the     universal prevention level, developed by Swedish researchers for the school years 4 -9. By     defining and teaching school rules to all teachers and students, and by consistently     acknowledging students when meeting behavioural expectations, the program aims to reduce     problem behaviours in school areas and to improve the classroom learning climate. Against     this background, the purpose of this study is to examine whether PS is more effective than     schools' ordinary practices in meeting these goals.   "
123415|NCT01670578|"     The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP)     to treat knee degenerative articular cartilage pathology could determine pain relief and     recovery of knee function with overall clinical outcome comparable or even better than     viscosupplementation, which is a common injective approach applied in this kind of pathology.     To this purpose the investigators designed a double blind randomized controlled trial     comparing PRP vs viscosupplementation.      A power analysis has been performed for the primary endpoint of IKDC (International Knee     Documentation Committee) subjective score improvement at the 12-month follow-up for PRP. From     a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a     beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding     at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group.     Considering a possible drop out of 15%, 96 patients per group are required for total 192     patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria'     section). Patients are then assigned to two different treatment groups, according to a     randomization list. The first group of treatment consists of three weekly intra-articular     injections of autologous PRP obtained with the following procedure: a 150-ml autologous     venous blood sample undergoes 2 centrifugations (the first at 1480 rpm for 6 minutes to     separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to     produced 20 ml of PRP. This unit of PRP is then divided into 4 small units of 5 ml each. One     unit is sent to the laboratory for analysis of platelet concentration and for a quality test,     3 units are stored at -30° C.      The second treatment group consists of patients receiving three weekly injections of     hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500     kDa).      To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain     autologous PRP which will be used only in half of them, according to the aforementioned     randomization list. One week after the PRP production, the injective treatment starts, with 3     weekly injections of PRP or HA. At the moment of the injection the syringe is properly     covered to prevent the patient from discovering the substance he was receiving. After the     injection, patients are sent home with instructions to limit the use of the leg for at least     24 h and to use cold therapy/ice on the affected area to relieve pain. During this period,     the use of non-steroidal medication is forbidden.      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using     clinical subjective scores and objective parameters to determine clinical outcome (see     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.     All the clinical evaluations are performed by a medical staff not involved in the injective     procedure, in order to keep the study double blinded. At the end of the study, the nature of     the injected substance is revealed to the patients.   "
137953|NCT01479062|"     The trial will test whether the Alive multi-channel delivery health behavior program can     positively affect weight and glucose level in pre-diabetics.   "
123416|NCT01670565|"     This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled,     proof-of-concept pilot study. All participants will first be treated with mycophenolate     mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half     will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early     diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity     measured by an improvement in skin thickening and stability of pulmonary function test     measurements when compared to patients treated with placebo/MMF.   "
123417|NCT01670552|"     The purpose of this study is to evaluate the safety of an association with one     anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and     one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.   "
123418|NCT01670539|"     The purpose of this study is to learn more about using a home machine Telemonitor to find     problems people with lung cancer may have after being discharged from the hospital and help     them manage problems by contacting their healthcare provider.The study hypothesis is that     patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses     on telemonitor data risks/implications for the first two weeks after hospital discharge, will     be able to self-report their signs/ symptoms to the clinician resulting in decreased use of     costly health care resources over 60 days.   "
123419|NCT01670526|"     Difficulties with intellectual functioning, particularly memory functions, are common and     source of long-term disability after Traumatic Brain Injury (TBI). However, there is very     little information about pharmacologic (i.e., medication) treatments targeting these     deficits. There are growing data showing brain abnormalities in acetylcholine, the chemical     system that manages memory, in TBI. These findings provide the rationale for the use of     cholinesterase inhibitors, medications that modulate this system, in TBI patients. As the     prevalence of TBI among Veterans of recent military conflicts increases, becoming a     signature injury of the Iraq and Afghanistan conflicts, it is of utmost importance to the     Veterans Health Administration to collect scientific data on the efficacy of pharmacological     treatments for intellectual difficulties in TBI patients. This study will evaluate the     effects of the cholinesterase inhibitor rivastigmine transdermal patch in Veterans with TBI     and posttraumatic memory problems. Results will provide much needed data that will help treat     Veterans with TBI.   "
123420|NCT01670513|"     Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area     affected will be enrolled in the study.   "
123421|NCT01670500|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well     it works in treating a specific cancer. Investigational means that cisplatin is still being     studied for use in this setting and that research doctors are trying to find out more about     it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation     carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer.     Cisplatin has been approved by the FDA for treatment of other cancers.      The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown     to be active in the treatment of women with breast cancer and a BRCA mutation. In this study,     we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide     (AC) that you might receive if you did not participate in this study.   "
123422|NCT01670487|"     To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in     decreasing the pain of intravenous cannulation.      To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water)     stream.   "
123423|NCT01670474|"     Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified     film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive     polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was     reduced in the modified catheter compared with standard catheter. The clinical investigation     revealed that both number of days before catheter removal according to clinical requirements     and number of treatments per catheter were significantly higher with the modified catheter as     compared with the standard catheter.      Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter     thrombosis. The relatively high cost of rt-PA and its theoretical potential to cause     bleeding, as well as the morbidity and mortality associated with catheter malfunction and     infection, justify the need for more definitive evidence of the efficacy of rt-PA as a     locking solution.      No study aims to evaluate the impact of rt-PA locking in long-term Hemodialysis (HD) uncuffed     catheters survival.   "
123424|NCT01670461|"     Advance Care Planning (ACP) prepares patients and their loved ones for future health care     decisions, including end-of-life decisions. Yet, the needs of adolescent oncology patients     for participation in ACP, despite its priority, is not well studied. Our goal is to test a     model of ACP that anticipates these issues, fully empowers the family and adolescent, and     keeps the key role of health care professionals central, building on our earlier work. We     hypothesized FAmily CEntered (FACE) ACP, would: (1) increase congruence in treatment     preferences between adolescents and surrogates; (2) decrease decisional conflict for     adolescents; and (3) increase quality of communication compared with controls.   "
123425|NCT01670448|"     Pain after breast cancer surgery could be severe and about 1/3 of patients will develop     chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral     muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of     this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor     and major breast surgery. The prevention of chronic pain following surgery will also be     evaluated.   "
123426|NCT01670435|"     This study is a post-marketing surveillance in Japan, and it is a local prospective and     observational study of patients who have received Ciproxan intravenously as a first-line     treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical     or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective     of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A     total of 3,000 patients are to be enrolled and assessed during the period of treatment with     Ciproxan.   "
125436|NCT01643226|"     The objectives of this study are to evaluate the safety and efficacy of corneal collagen     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as     compared to placebo in impeding the progression of, and/or reducing, maximum corneal     curvature.   "
123441|NCT01670240|"     This study wants to investigate the efficiency of biological treatment for chronic pouchitis.     Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It     is examined in patients with ulcerative colitis.      The primary objective evaluation is to evaluate the clinically effect of biological therapy     (adalimumab) in patients with chronic pouchitis.      Secondary objective is to evaluate the effect of biological therapy on the endoscopical and     histological inflammatory activity.      It is a double-blinded randomized placebo controlled study.   "
123442|NCT01670227|"     The purpose of this study was to determine whether ParentCorps promotes academic achievement     and prevents mental health problems in children living in disadvantaged urban communities   "
123427|NCT01670422|"     Clinically, recurrence and life-threatening complications are challenging problems for     chronic suppurative osteomyelitis of the jaw. There is no quantitative analysis or report     about the causes of or risk factors for the two problems. Doctors identify the causes or risk     factors only through clinical experience. The investigators performed a retrospective study     of 322 patients with chronic suppurative osteomyelitis of the jaw. The risk factors for the     above mentioned two problems were analyzed by logistic regression analysis. The investigators     found that some of the patients' general conditions, including age, admission temperature,     admission white blood cell count, pre-admission antibiotic administration without     consultation, location of the lesion, and general patient condition, were the risk factors.     The results indicate that doctors should be mindful of those risk factors and that the     management should be more aggressive when the above risk factors are present.   "
123428|NCT01670409|"     The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year     local control and overall survival rates in patients with esophageal squamous cell carcinoma     receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.   "
123429|NCT01670396|"     The investigators hypothesized that genetic variants of G protein influence the development     of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).   "
123430|NCT01670383|"     The objective of this study is to find a new therapeutic strategy by investigating the serial     serum samples of patients with sepsis or postresuscitation state.   "
123431|NCT01670370|"     The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and     Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with     aggressive B cell lymphoma.   "
123432|NCT01670357|"     This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared     with placebo in dry eye syndrome.   "
123433|NCT01670344|"     This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative     positioning system in the clinical setting of orthopedic surgery.      Aim of the study is the validation and comparison of the innovative medical device with the     current standard method.   "
123434|NCT01670331|"     Is it feasible to perform a randomized controlled trial to assess whether or not     psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial to     the investigators patients?   "
123435|NCT01670318|"     Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium     everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the     identical antiproliferative agent and polymer but with a novel platinum chromium scaffold     designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity,     radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex     coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left     main trunk disease, and small vessel diseases is still unknown.   "
123436|NCT01670305|"     Residual pockets and furcation defects are challenging sites that require additional     periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic     therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT     in association with scaling and root planing (SRP) in class II furcation lesions with probing     pocket depth (PPD) >5mm and bleeding on probing (BoP). A blind randomized controlled clinical     trial was conducted in subjects presenting at least three residual pockets in single root     teeth and subjects with at least one molar presenting class II furcation defect. To evaluate     the effect of a single PDT as monotherapy in residual pockets, the selected sites were     assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate the effect of     PDT in association with SRP in class II furcation lesions, the selected sites were assigned     to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic analyses were assessed     at baseline, 3 and 6 months post-therapies.   "
123437|NCT01670292|"     This is a biomechanical study which is Project 1 in the Developmental Center for Clinical and     Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01; principal     investigator Christine Goertz, DC, PhD). This study is designed to monitor both physiological     and patient self-report outcome variables. In addition, as there is little quantitative     information on Spinal Manipulation Technique procedures reported in clinical trials, the     study is designed to collect preliminary kinetic measures of the spinal manipulation     technique delivery (i.e. force-time profiles).   "
123438|NCT01670279|"     The purpose of this study is to assess the safety and tolerability of ascending multiple oral     doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.   "
123439|NCT01670266|"     The primary objective of this study is to evaluate the safety and tolerability of 3 planned     doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension     (OHT) or mild open angle-glaucoma (OAG).      The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the     pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its     tolerability following morning and evening dosing.   "
123440|NCT01670253|"     The primary objective is to investigate whether intake of approximately 200 ml of sugary     fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of     fasting period for patients without reducing the quality of the study.      Current standard for fasting and fluid intake before gastroscopy is completely fasting 6     hours before the study. Studies in patients in general anesthesia has been found that it does     not increase the risk of aspiration of stomach content during the operation by allowing the     patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have     examined the quality gastroscopy using this fasting procedure. Some studies show that intake     of sugary liquids do not have significant effect on gastric emptying.      There are not deemed to be ethical problems with this study, as it seeks to show that a more     lenient standard procedure in endoscopy is as safe as the established. The study is     considered safe.   "
123459|NCT01668966|"     This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01649804)     will evaluate the safety and efficacy of tocilizumab in participants with early moderate to     severe rheumatoid arthritis who have completed the 104-week WA19926 (NCT01649804) core study.     Eligible participants will be those who are expected to benefit from the study medicine based     on the investigator's discretion.   "
123444|NCT01670201|"     The investigator will identify the test donor site and test location will be considered on     the upper anterior thighs as being the most suitable if available. Circumferential donors     will be considered acceptable as well.      Treatment will be initiated in the operation room following debridement and split thickness     grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and     dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked     lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be     applied directly to study site. Secondary dressing will include covering with ace wrap.      Healing should be asses after 10-14 days.   "
123445|NCT01670188|"     Determine if the use of sequential pneumatic compression in the arm can prevent the formation     of venous clots related to the presence of a peripherally inserted central catheter (PICC).   "
123446|NCT01670175|"     This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and     topotecan. This is the first study to evaluate the safety and clinical activity of the     combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and     young adult patients with relapsed and refractory solid tumors.      In this phase I study, the mTOR inhibitor sirolimus will be administered in combination with     oral cyclophosphamide and oral topotecan to children with relapsed or refractory solid     tumors. The primary aim of this study is to recommend a phase II dose schedule and describe     the toxicity of this combination. Myelosuppression will be a targeted toxicity.   "
123447|NCT01670162|"     The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept     injection in a population of neovascular AMD patients that have been previously treated with     2.0 mg ranibizumab for persistent PEDs.   "
123448|NCT01670149|"     Clostridium difficile associated diarrhoea is an important cause of morbidity in patients     treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of     initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a     poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to     carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given     in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.   "
123449|NCT01670136|"     The purpose of this study is to learn more about the safety and dosing of sildenafil in     infants.   "
123450|NCT01670123|"     This three-year intervention development proposal is submitted to the NIMH DATR Mood     Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this     study is to further develop and then evaluate the clinical utility of a new personalized     smart-phone intervention to enhance illness self-management in people with bipolar disorder.     Bipolar disorder is a heterogeneous fluctuating condition and a leading source of disability.     Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to clinical     management and evidence-based psychosocial interventions for bipolar disorder. Practice     guidelines state that all patients should receive education in self-monitoring and     identifying adaptive responses to early warning signs and symptoms. Advances in technology     have enabled electronic monitoring of patient-reported outcomes using mobile devices - an     assessment strategy called Ecological Momentary Assessment (EMA). Using freely available     software, we have developed a preliminary version of a novel smart-phone intervention that     integrates EMA with brief psychosocial intervention designed for people with bipolar     disorder. Mobile real-time interventions have been successfully applied in other chronic     illnesses and have theoretical advantages over clinic-based interventions in motivating and     cuing health-protective behavior. Our new intervention is called Personalized Real-Time     Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content     naturalistically at the moment that symptoms occur. We recently conducted a small     proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the     intervention is feasible, presents no technological or operational barriers, yields data that     corresponds with clinical ratings, and is perceived as useful by participants. Building from     our preliminary work, we propose to further develop the intervention based on participant     feedback and theoretically-driven enhancements. We will then conduct a randomized trial to     assess the clinical utility of this new intervention over 12 weeks. Specifically, we will     randomize a sample of 90 adults aged 18 and older with Bipolar Disorder I or II to one of two     experimental conditions. Participants in both conditions will participate in two in-person     sessions adapted from an evidence-based psychosocial intervention for bipolar disorder, aimed     at identifying early warning signs and adaptive responses to symptom fluctuations. The     Control condition will participate in the in-person sessions, and the PRISM condition will     also utilize the smart phone device for 12 weeks. In this pilot trial, we will compare     outcomes between the two conditions on standard clinical ratings of depressive and manic     symptoms, along with psychosocial functioning. We will assess predictors of compliance and     changes in outcomes in the PRISM condition to inform a larger effectiveness trial. We will     use exploratory analyses to further refine the intervention, including capitalizing on the     rich repeated measures obtained by the device. This study will provide a strong basis for a     larger effectiveness trial, along with a potentially useful tool to enhance self-management     in bipolar disorder. PUBLIC HEALTH RELEVANCE: Bipolar disorder is a leading cause of     disability, and many people do not have access to evidence-based psychosocial interventions.     Mobile devices may prove more effective than clinic-based interventions, because they deliver     self-management strategies at the moment that symptoms occur. To lead to a larger     effectiveness study, we propose to further develop our novel intervention uses mobile     technology to monitor and intervene with symptoms in real-time, and then conduct a 12-week     randomized trial in 90 patients to evaluate the acceptability and short-term efficacy of our     smart-phone based intervention for bipolar disorder.   "
123451|NCT01670110|"     The purpose of this study is to compare SOM230 treatment to placebo. The investigators will     also assess the efficacy and safety of SOM230 in reducing total liver volume and improving     quality of life.   "
123452|NCT01670097|"     The goal of this clinical research study is to learn if dexamethasone can help reduce     shortness of breath in cancer patients. Researchers also want to learn if it can help to     improve lung function and quality of life. In this study, dexamethasone will be compared to a     placebo.      Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help     patients with shortness of breath.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
123453|NCT01670084|"     In this study researchers want to find out more about the side effects of a new drug for     Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic     myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to     nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD     is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin     (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for     patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all     the ways that this drug may affect people   "
123454|NCT01670071|"     The purpose of this study is to compare the effect of oral paliperidone extended-release and     oral risperidone immediate-release on cognitive function, especially the category fluency of     Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an     established diagnosis of schizophrenia.   "
123455|NCT01670058|"     -  The prevalence of Belatacept use        -  The characteristics of Belatacept users and the temporal trends in these characteristics        -  Characteristics of adult kidney-only transplant recipients who are treated with          Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the          time of transplantation, and the temporal trends in these characteristics during 7 years          post approval of Belatacept.   "
123456|NCT01670045|"     This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra     (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients     initiated on RoActemra/Actemra treatment according to the licensed label will be followed for     6 months.   "
123457|NCT01670032|"     This study will be a multicenter, randomized, vehicle controlled, parallel, group, double     blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to     one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel     applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments     will be administered for 7 days. Disease activity for the Target Lesion will be evaluated     using the Skin Infection Rating Scale (SIRS) Score.   "
138170|NCT01476449|"     This study is to see whether treating diabetic retinal swelling with ranibizumab injections     into the eye monthly is better than treating diabetic retinal swelling with ranibizumab     injections into the eye less frequently.   "
123474|NCT01669824|"     In this non-interventional one year study, data about overall and particularly     gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are     collected by basic questionnaires, which are handed out by pharmacists to patients who     acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter)     Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study.     After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get     information about safety, usage and compliance under everyday's conditions, because in     Germany low-dose aspirin is an OTC product with Rx indication.   "
123503|NCT01669447|"     Significant difference in the parameter settings of early optical coherence tomography (OCT     spectal domain) in patients with subfoveal neovascular membrane realacionada age after     treatment with a single intravitreal injection of Lucentis.   "
123460|NCT01668953|"     Tennis elbow is the most common cause of lateral elbow pain, generally caused by either     work or sports related repetitive strain. In this condition, a tendon along the outside of     the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.      Many treatments have been attempted, including physiotherapy and steroids, with little     success. One treatment which has been very effective is the injection of the patients own     blood (taken from their other non-affected arm) into their abnormal tendon. The blood     recruits the patients own healing factors and heals the damaged tendon. As platelets are     thought to be largely responsible, injection of concentrated platelets, extracted from the     patient's blood (platelet rich plasma) is a newer, but expensive, technique.      At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a     ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing     (tendon fenestration) is the better treatment.      The objective of this trial is to compare platelet rich plasma, whole blood, dry needle     tendon fenestration, and sham injection (with physical therapy) to identify the best and most     cost-effective therapy for this debilitating condition.   "
123461|NCT01669993|"     The purposes of the study are to identify 1) the patient (demographic and clinical) and     health care system factors predictive of immediate and late postoperative adverse outcomes in     children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep     questionnaire to identify children at risk for immediate and late postoperative adverse     outcomes in children undergoing tonsillectomy.   "
123462|NCT01669980|"     This is a study of safety and effectiveness of ceftaroline fosamil in children with     Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.   "
123463|NCT01669967|"     Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic     pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is     good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the     management of neuropathic pain in the short term - up to six hours.   "
123464|NCT01669954|"     The purpose of this study is to determine the bone mineral density in male and female     patients with HIV infection according to age groups.      This will enable a practical approach to screening for osteoporosis and the management and     prevention of fragility fractures in people with HIV.      In addition, all risk factors commonly associated with fragility fractures and osteoporosis     are collected, as is HIV drug history.      Hence, as secondary outcomes, the associations with reduced bone mineral density can be     ascertained.   "
123465|NCT01669941|"     Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of     maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy     (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals     in the second and third trimesters of pregnancy irrespective of the presence of malaria     parasitemia, is currently recommended for HIV-negative women in all areas with stable     moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer     used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be     decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for     IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy     (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care     (FANC) with treatment of women who screen positive.      The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a     reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an     area with decreasing malaria transmission and high levels of SP resistance in Kenya.   "
123466|NCT01669928|"     A randomised crossover trial of anti-hypertensive medication dosing regimen in effective     blood pressure control.      To investigate whether there is a difference in 24 hour blood pressure (BP) control when     antihypertensive medications are taken in the morning compared with the evening. The     identification of any significant difference could lead to more effective therapeutic     management of arterial hypertension, which in turn would result in a reduced cardiovascular     burden, lower costs and a better quality of life for hypertensive patients.   "
123467|NCT01669915|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses. This ancillary study is being conducted among participants in VITAL and will     examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older     participants of VITAL.   "
123468|NCT01669902|"     This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab)     in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use     methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for     6 months.   "
123469|NCT01669889|"     This multi-center, non-drug study will explore the relationship between exploratory     biomarkers and functional dimensions in male adult individuals with Autistic Disorder or     Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of     assessments on study visit Day 1.   "
123470|NCT01669876|"     To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on     blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's     Disease (AD) in subjects with mild to moderate AD.   "
123471|NCT01669863|"     Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute     respiratory failure   "
123472|NCT01669850|"     The purpose of this study is to determine whether handsewn anastomosis versus clipped     technique is associated with more complications, fistula failures, surgical cost and surgical     time.   "
123473|NCT01669837|"     Prospective, multicenter, observational registry to collect data of laparoscopic inguinal     hernia repair using surgical tissue glue fixation. The objective is to determine the     prevalence of chronic pain at 1 year.   "
123549|NCT01668823|"     This phase I trial is studying the side effects and best dose of photodynamic therapy using     HPPH in treating patients with lung cancer. Photodynamic therapy uses a drug, such as HPPH,     that becomes active when it is exposed to a certain kind of light. When the drug is active,     cancer cells are killed.   "
123550|NCT01668810|"     The investigators aimed to examine the psychotropic prescription pattern in China.   "
123475|NCT01669811|"     This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to     evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20     mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux     esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of     presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA)     classification   "
123476|NCT01669798|"     The main purpose of this study is to see if BIBF 1120 can increase the number of women with     bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress     for at least six months.   "
123477|NCT01669785|"     The study is intended to verify through clinical measurement that the NUPRO Sensodyne     Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended     relief up to 28 days.   "
123478|NCT01669772|"     DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These     plants have been used in oriental traditional medicine for the treatment of gastrointestinal     maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in     functional dyspepsia patients and proved to have comparable safety and efficacy. However,     its' exact effect on the gastrointestinal motility has not been completely elucidated. This     study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.   "
123479|NCT01669759|"     The purpose of the present study was to investigate the correlation between the severity of     fatigue, and the severity of qi deficiency and blood stasis.   "
123480|NCT01669746|"     Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female     subjects with hair loss.   "
123481|NCT01669733|"     The purpose of this research is to study the effect music has on women undergoing surgical     breast biopsy. Through the facilitation of live and/or recorded music listening, we will     examine the perception of patient anxiety, the total amount of propofol required to obtain a     BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the     effect of live and/or recorded music on patient satisfaction. It is hypothesized that:        1. Patients in the live and recorded music groups will experience less anxiety than the          non-music (standard care) group.        2. Patients in the live and recorded music groups will experience a reduction in the amount          of anesthesia needed to reach a state of moderate sedation compared to the non-music          (standard care) group.   "
123482|NCT01669720|"     The main purpose of this study is to evaluate if aflibercept can reduce the chance that     metastatic (spread of) colorectal cancer can grow back after finishing standard treatment.     The study will also look at the side effects of aflibercept and the effect on quality of     life.   "
123483|NCT01669707|"     The purpose of this study is to determine whether Endostar pumping into vein with     Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly     in the treatment of Non-Small Cell Lung Cancer (NSCLC).   "
123484|NCT01669694|"     This study is collecting serum and urine samples at various time points during pelvic floor     physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and     proteomics at various time points.   "
123485|NCT01669681|"     The severe asthma is a major source of expenses in term of public health, while it concerns     no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations,     care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort     of more than 500 severe asthmatic patients multicentrique in an already widely established     cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime     opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a     real medical economic variable. The possibility of dynamic follow-up of the expenses compared     to the medical data offers perspectives of evaluation cost-efficiency of the informed     therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the     data of health stemming from a cohort with the economic data stemming from the CPAM. This     variable included in a Cluster's algorithm has to allow to identify the interventions the     more and the less cost effective. The main objective of this study is to realize a cost     estimate of care of the severe asthma. The variation of the costs will be also studied. The     recruited patients are patients already included in the cohort COBRA in the centers of     Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.   "
123486|NCT01669668|"     This phase II trial studies how effectively radiofrequency ablation prevents recurrence of     hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency     ablation uses a high-frequency, electric current to kill tumor cells.   "
123487|NCT01669655|"     To characterize nutrient levels in breastfeeding infants and their mothers.   "
123488|NCT01669642|"     The purpose of the study is to find the dose of rapidly administered ketamine in 3 different     pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction.      Ketamine is the most common drug administered to children to facilitate painful procedures in     the emergency setting because it achieves potent sedation, pain relief and amnesia with     minimal adverse cardiopulmonary effects.(1-5) However, the 1-2 hour recovery period (1,6)     associated with standard ketamine administration guidelines(7) strains work flow because it     requires bedside one-on-one nurse monitoring in a treatment room, tying up these limited and     valuable resources. Consequently, a combination of two other drugs, propofol + fentanyl     (P/F), with recovery of 20-30 minutes, is rapidly gaining popularity for procedural sedation     despite more frequent respiratory depression, apnea and hypotension caused by this     technique.(2,4,8,9)      The investigators believe recovery associated with our novel method for administering     ketamine is significantly shorter than with the standard larger dose more slowly administered     ketamine technique(7). Through the investigators clinical experience, the investigators have     found rapid infusion of smaller than standard doses of ketamine safely achieves the drug's     sedative effect, with the benefit of more rapid recovery due to the use of a smaller dose.     However, this novel technique challenges published beliefs that time of recovery from     ketamine sedation does not differ significantly with the dose administered, within the usual     dose ranges, and that rapid infusion may cause respiratory depression, similar to that seen     with other classes of sedative-analgesic drugs.(7,10) the investigators believe the slow     infusion recommended by standard guidelines(7) requires a larger ketamine dose necessary to     achieve effective sedation, and, consequently, prolongs recovery. It is the prolonged     recovery that has prompted increased use of other less safe but briefer sedatives, such as     propofol/fentanyl. By demonstrating patients recover rapidly with new ketamine technique,     without increased adverse cardiopulmonary effects, the investigators will provide clinicians     with an important new method for ketamine procedural sedation. The investigators believe     clinicians will prefer more rapid recovery ketamine technique because it is safer and reduces     pain and distress better than the propofol/fentanyl combination for sedation.      The investigators complete proposal requires two steps. In Step One, this proposal, the     investigators will determine the minimum effective dose of rapidly infused ketamine that     achieves deep sedation for at least 5 minutes in 95% of children (ED95). Two groups of     patients will be studied: one group is patients undergoing abscess incision and drainage and     the other group is patients undergoing fracture reduction in our Emergency Department. The     investigators believe that the ED95 is different for both the groups as the severity of pain     is different. The investigators will compare the safety and recovery times to published     standard ketamine techniques. In the following study, Step Two, the investigators will     compare this novel technique, in a blinded randomized trial using the ED95 ketamine dose     determined in Step One to the standard ketamine technique to determine if the novel technique     results in significantly shorter recovery without an increase in the frequency of adverse     effects. The study the investigators are proposing in this submission is Step One only.   "
123489|NCT01669629|"     This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a     primary hypothesis of comparing the handling of each lens. Additional secondary markers are     measured looking at subjective comfort and vision of the lenses.   "
123490|NCT01669616|"     The primary objective of the trial is to collect SCOUT DS, random capillary glucose and     Hemoglobin A1c measurements from subject 18 years of age or older.   "
123491|NCT01669603|"     The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive     host responses to rhinovirus infection.   "
123551|NCT01668797|"     The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo     as maintenance treatment in adults with schizophrenia.   "
123552|NCT01668784|"     The purpose of the study is to compare the clinical benefit, as measured by duration of     overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic     clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy   "
123492|NCT01669590|"     The goal of the research project is to determine how aging and inactivity reduce the muscle     anabolic effect of nutrients and lead to muscle and functional loss. The central hypothesis     is that aging reduces mTORC1 signaling and the expression of skeletal muscle amino acid     transporters in response to anabolic stimulation leading to reduced muscle adaptation to     increased intracellular amino acid requirements. The investigators further hypothesize that     inactivity exacerbates this effect with significant muscle and functional loss, and     rehabilitation restores muscle signaling, metabolism and function to baseline values.   "
123494|NCT01669564|"     This study will evaluate a new tool, based on our currently implemented Functional     Assessment Screening Tablets (FAST), and activate patients to partner with their physicians.     Completion of this project, FAST-PRI, will provide important information on the effectiveness     of using HIT patient feedback to inform and activate patients and promote health behavior     change.      Aim 1 Hypotheses: Patients who receive self-management support through HIT patient feedback     (intervention) will be more likely than patients who do not receive such feedback (control)     to:        -  Initiate discussions with their provider regarding study-designated PRI;        -  Have discussions with their providers, regardless of the initiator, regarding          study-designated PRI; and        -  Perceive these discussions of study-designated PRI to be useful. Approach: We will          conduct a 12-month randomized controlled trial of HIT patient feedback, clustered at the          physician level, in an academic group medical practice. Patients and providers will          complete questionnaires regarding discussions of health behaviors and HRQoL at each          clinical encounter.      Aim 2 Hypotheses: HIT patient feedback will result in: 1) increased number of smoking quit     attempts, 2) increased physical activity, and 3) improved mental HRQoL at six, and twelve     months.      Approach: Patient participants will complete questionnaires regarding smoking quit attempts,     physical activity, and their mental HRQoL at baseline, six and twelve months.      Aim 3 Hypotheses: For each study-designated PRI, patients who receive HIT patient feedback     will: 1) receive more treatment recommendations (e.g., nurse educator, pharmacist, social     worker referrals); 2) act on more treatment recommendations; and 3) exhibit improved     self-efficacy regarding their ability to make positive lifestyle changes and improve their     HRQoL; physicians whose patients receive HIT patient feedback will have higher self-efficacy     regarding their ability to influence their patients to make positive lifestyle changes and     improve HRQoL. These, in addition to discussions (Aim 1), will mediate the relationship     between HIT patient feedback and improvements in study-designated PRI.      Approach: We will survey patients and physicians and abstract referral data from the     electronic medical record (EMR).   "
123495|NCT01669551|"     This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or     transesophageal echo in patients with structural and valvular heart disease who are already     scheduled to undergo a percutaneous intervention. Specifically those patients would be those     scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac     catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve     replacement.   "
123496|NCT01669538|"     This is a randomized, double-blind, placebo-controlled study to test whether a medication     called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces     cognitive problems that smokers experience during a quit attempt.   "
123497|NCT01669525|"     The purpose of this study to determine if measurement of maternal serum biomarkers and     evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy     outcomes.   "
123498|NCT01669512|"     ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied     in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated     viruses which have been modified so that they cannot reproduce in humans. Genetic information     has been added to make them express proteins of the malaria parasite so that they stimulate     an immune response against malaria. This trial examines whether a compound called Matrix M™     can be used in efforts to improve on how well the vaccines work at preventing malaria.      Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines.     In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to     assess the safety of the vaccines when combined with Matrix M™, and to determine what effect     Matrix M™ has on the immune responses to the vaccines.      We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA     METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring     them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of     Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six     volunteers will receive the vaccines alone as a comparison group. We will also look at what     effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests.     Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical     Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have     blood taken to monitor safety and measure immune responses to vaccination, and be monitored     for symptoms/side effects from vaccination.   "
123499|NCT01669499|"     Cancer patients with pain due to bone metastases are often treated with external irradiation     in order to reduce pain. However, patients may experience a temporary increase of pain     shortly after irradiation, a so-called pain flare. This study investigates whether a short     course of a drug called dexamethasone may prevent the occurrence of a pain flare. Patients,     who are irradiated for painful bone metastases are randomized into three groups. Group 1     receives placebo during four days, group 2 receives dexamethasone on the day of the     irradiation and placebo during three days, and group 3 receives dexamethasone during four     days. All patients complete a questionnaire on pain, side-effects of treatment and quality of     life during 14 days and after four weeks. This study will define whether dexamethasone     decreases the occurrence of a pain flare after irradiation for painful bone metastases, and,     if so, whether four days of treatment with dexamethasone is better dan one day of treatment.   "
123500|NCT01669486|"     The purpose of this research is to find the best system for assessing the pain of critically     ill patient in Intensive Care Unit (ICU).      At first the investigators assess the sedation of the patient with the scale     sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the     patient is too sedated or delirious the investigators consider him unable to use the Visual     Analogic Scale (VAS).      The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and     Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in     three different moments: before, during and after the nurses' care.      The investigators compare the scales between them. Then, every time the investigators value     the score of these scales with the self-report of patients with the VAS scale (when it is     possible) and finally with the physiological parameters (blood pressure, heart rate and     respiratory rate).      In the end, the investigators compare two different classes of patient: the surgical and     medical one. The investigators search for some differences in the perception of the pain     between these two classes.   "
138171|NCT01476436|"     Low carbohydrate diet may influence the plasma lipid levels.   "
123501|NCT01669473|"     This study seeks to evaluate a low-literacy strategy in a primary health care setting for     promoting safe and effective prescription medication use among English and Spanish-speaking     patients with diabetes.      The investigators hypothesize that in comparison with patients receiving standard care, the     patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better     understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies     in their medication lists; 3) take their medication regimen more efficiently; 4) have greater     adherence to their medication regimen.   "
123502|NCT01669460|"     The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce     fatigue in prostate cancer patients receiving LHRH agonist therapy.   "
123504|NCT01669434|"     Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and     including the morning of an intermediate risk surgery will experience more intraoperative     hypotension than those who hold their chronic ACEI perioperatively.      Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and     including the morning of an intermediate risk surgery will experience better postoperative     control of hypertension than those who hold their chronic ACEI perioperatively.      Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and     including the morning of an intermediate risk surgery will experience less acute renal     failure than those who hold their chronic ACEI perioperatively.      Secondary research hypothesis #3: Patients with a preoperative systolic blood pressure less     than 110 mmHg who are continued on their chronicACEI therapy perioperatively will have a     significant decrease in blood pressure during anesthesia compared to those who have a     preoperative systolic blood pressure greater than 110 who are continued on their chronic     ACEI.      Secondary research hypothesis #4: Patients above the age of 64 who are continued on their     chronic ACEI therapy perioperatively will have a significant decrease in blood pressure     during anesthesia compared to those aged 64 or younger who are continued on their chronic     ACEI.   "
123505|NCT01669421|"     The current treatment of individuals with alpha-1 antitrypsin deficiency (AATD) who develop     lung disease (COPD) is the administration of intravenous purified alpha-1 antitrypsin     (augmentation therapy) at a fixed dose of 60 mg/kg per week. This dose aims at increasing the     deficient AAT serum levels just above a predetermined safety threshold of 11 uM. However,     normal levels of AAT are between 25-50 uM.      AAT has shown not only to inhibit lung proteases such as neutrophil elastase, but also to     modulate inflammation. Given that many subjects with AATD who receive augmentation therapy     still have significant lung disease and inflammation, this study will evaluate whether     doubling the dose to 120 mg/kg/week has an effect in decreasing lung inflammation.      Only the dosing of 60 mg/kg /week has received FDA approval. FDA has granted an IND number to     this study to test the higher dose of 120 mg/kg/week.      The study will evaluate systemic (serum) and pulmonary (bronchoscopy samples)markers of     inflammation in 3 phases: standard dose (4 weeks), double dose (4 weeks) and standard dose (4     weeks).   "
123506|NCT01669408|"     Elevated body temperature was shown to be associated with worse outcome in acute stroke     patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital     cooling with cold infusions in stroke patients.   "
123507|NCT01669395|"     The purpose of this study is to investigate the effect of an early, coordinated     rehabilitation intervention for patients with severe heart failure in NYHA class III and IV     with a ejection fraction of <40% of normal cardiac function measured on frequency of     readmissions, physical ability and participation in activities of daily living and quality of     life.   "
123508|NCT01669382|"     Background:      Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve     patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions     (PCI). Despite higher complications rates in earlier studies, current data suggest similar     complication rates or better outcomes after the use of VCD as compared to manual compression.     ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA) plug which     occludes the puncture channel. Whether the use of this extravascular closure device is as     effective as the more widely used plug/anchor mediated devices, has not been evaluated so     far.      We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the     extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor mediated     AngioSeal system.      Methods:      304 patients receiving diagnostic angiography and/or PCI will be included in three centers.     Exclusion criteria are contraindications for any VCD including 1. severe calcification of the     access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the profound     femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac     artery, 5. marked obesity or cachexia (BMI >40 or <20) and 6. patients on continuous     medication with oral anticoagulants.      After the procedure, angiography of the accessed femoral artery is performed to rule out     major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the common     or the superficial femoral artery, or a location of the puncture site in the bifurcation of     the profundal femoral artery.      We hypothesise, that the use of an extravascular closure device is not inferior to an     anchor/plug mediated device regarding the occurrence of the following complications:     bleeding, need for vascular surgery and device failure (primary endpoints). Secondary     endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm     within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be     defined according to the TIMI criteria. The study is actively enrolling patients, last     inclusion will take place in September 2012.      Results and Conclusions:      Outcome data including the primary endpoint (bleeding, need for vascular surgery and device     failure) will be presented for the first time.   "
123509|NCT01669369|"     The purpose of this study is to determine whether Lithium Carbonate combined with     neo-adjuvant chemotherapy improve the prognosis of osteosarcoma   "
123510|NCT01669356|"     Malnutrition is common in esophagus cancer patients, especially after surgery therapy.     Whether parenteral supplement with enteral nutrtion is benificial for patients after     esophagectomy is controversial, when compared with enteral nutrition alone. In this study,     the investigators are to examine the effect of enteral nutrition supplemented with parenteral     nutrtion on nutrition status after esophagectomy.   "
123511|NCT01669343|"     The purpose of this study is to examine how key patient factors, including body size affect     how well letrozole suppresses circulating estrogen levels.      This study has two components: (1) Part A - an observational phase to evaluate the impact of     vitamin D and obesity on estrogen suppression in post-menopausal women already receiving     letrozole treatment, and (2) Part B - an interventional phase for women with body mass index     (BM) > 25 kg/m2.      If BMI or other patient factors reduce the effectiveness of letrozole, modifications to     treatment recommendations and studies to test higher dosing of letrozole may be needed to     maximize the benefit of this treatment and minimize the risk of the breast cancer coming     back.   "
123512|NCT01669330|"     The most widely used operative technique for gastroesophageal reflux is total fundoplication     where the gastric fundus is sutured around the distal esophagus like a wrap. This operation     effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related     to over-competence of the gastroesophageal junction. 40% of the operated patients experience     increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique     where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of     the front wall of the esophagus is covered with fundus. An anterior fundoplication is un     attempt to create a more physiologic reflux control and less functional problems     postoperatively. The aim with this study is to compare the results postoperatively, both     short time and long time results.   "
123513|NCT01669317|"     This study is designed to demonstrate that cherry juice is effective in treating insomnia,     and to show that it works by inhibiting an enzyme that will be measured in the blood.   "
123514|NCT01669304|"     Vestibular migraine (VM) and chronic subjective dizziness (CSD) commonly cause vertigo,     unsteadiness and dizziness. Clinical investigators are studying these illnesses to understand     them better. VM and CSD occur together in about 1/3 of patients. That makes it hard to     diagnose them accurately and decide what treatments to use. As a result, doctors and patients     may be confused about these diagnoses. The goal of this study was use two different     medications to tease apart the symptoms of VM and CSD.      Patients who have VM and CSD together were given either verapamil or sertraline for 12 weeks.     These medications are used to treat VM and CSD, though they are not approved for this     purpose. Verapamil is believed to have stronger effects on symptoms of VM. Sertraline is     believed to have stronger effects on symptoms of CSD. By comparing the responses of patients     to these two medications, the researchers hoped to learn more about the key features of VM     and CSD.   "
123515|NCT01669291|"     The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long     protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for     assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.   "
123516|NCT01669278|"     The processing of standard flexible nasopharyngoscopes is a time-consuming and costly     process. The goal of this study is to determine the efficiency and cost-effectiveness of     sheathed flexible endoscope in an office setting.   "
123517|NCT01669265|"     This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early     breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by     one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.      The aim of the present study is to assess the intraoperative positive SLN total tumor load     (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN     metastasis in patients with clinically node-negative early-stage breast cancer.   "
123518|NCT01669252|"     This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory     pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with     operable Stage III HER2 non-overexpressing breast cancer.   "
123519|NCT01669239|"     This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of     neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients     with HER2-positive breast cancer   "
123520|NCT01669226|"     The purpose of this study is to evaluate the role of an additional intraperitoneal     chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.   "
123521|NCT01669213|"     The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3     receptor antagonists on prevention of hypotension after spinal anesthesia   "
123522|NCT01669200|"     The primary aim of this study is to assess whether daily dosing with medium chain     triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive     performance.   "
123523|NCT01669187|"     It is expected that patients who receive physical therapy before surgery will have greater     range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety     following surgery compared to those in the control group.   "
123524|NCT01669174|"     This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of     BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh     muscle volume compared to placebo. The study will last for approximately 24 weeks.   "
123525|NCT01669161|"     Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll.     Patients will be randomized to one of two groups - a group implanted with a device that     allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no     implant). Patients have two baseline evaluations, one evaluation after implant but before     initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS,     followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of     treatment. The intent is to assess safety and provide preliminary effectiveness information     for VNS for upper limb functional improvement after stroke. Implanted patients may receive     longer-term treatment and follow-up after the acute study.   "
123526|NCT01669148|"     The primary hypothesis to be tested is:      The detection of breast cancer will be increased with tomosynthesis (3D) imaging   "
123527|NCT01669135|"     The cerebral oxygen saturation is assessed by means of near-infrared spectometry in     parturients undergoing cesarean delivery under spinal anesthesia. The investigators     hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.   "
123528|NCT01669122|"     This is a randomized, single center, open label, single dose, four way crossover study in     fasted healthy male subjects to compare the pharmacokinetics of nicotine following     administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg     nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12     hours post dose in each treatment session and plasma samples analyzed for nicotine levels.   "
123529|NCT01669109|"     Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques,     and meditation. It is used in India since centuries to improve well-being and cope with     diseases and is gaining more and more interest in Europe and the US. While studies have     demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients     with colorectal cancer are available yet. The purpose of this study is to investigate the     effect of Hatha Yoga in patients with colorectal cancer.   "
123530|NCT01669096|"     The purpose of this study is to assess the safety and immunogenicity of two doses of the TB     vaccine administered according to a 0, 1 month schedule. In, addition, blood samples     collected at different time points after vaccination will be analysed to see when exactly     genes are activated by the vaccine using an assay called mRNA expression profiling. The     different methods for mRNA expression profiling using whole blood samples versus Peripheral     Blood Mononuclear cell(s) (PBMCs), will also be compared.   "
123721|NCT01666587|"     The purposes of this study are two-fold. The first purpose is to determine the effect of     taking vitamins on the recovery of an artery (blood vessel) following an induced temporary     injury. The second purpose is to determine whether a specific vasodilator is less abundant     after the injury and whether this contributes to increased constriction or after the injury.     Finally, does vitamin consumption have an effect on the recovery from the injury if one of     the substances in the blood that causes vessels to enlarge (dilate) is stopped?   "
123531|NCT01669083|"     GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst     implantation in women undergoing IVF treatment. This study will be the first dosing     experience with this compound in women. It is important to characterize the pharmacokinetics     of GSK557296 in women to determine the most appropriate doses and dosing regimens for future     clinical studies. Understanding the pharmacokinetics of GSK557296 in women will also enable     more accurate characterization of any exposure-response relationship in future studies.      Two previous studies with GSK557296 were conducted in men with oral doses ranging from 10     milligram (mg) to 200 mg. GSK557296 is being studied in women for the indication of enhanced     embryo and or blastocyst implantation in women undergoing IVF treatment. This is a bridging     study to characterize the pharmacokinetics of GSK557296 in women to determine the most     appropriate doses and dosing regimens for future clinical studies.      This is a non-randomized, open label, adaptive design study in healthy female volunteers. A     maximum total of 48 subjects, will participate in different cohorts. Subjects in Cohort 1     will receive 10 mg single dose followed by repeat dose. A one week break will occur to allow     for analysis of the PK data, prior to starting the second Cohort. Subjects in Cohort 2 will     receive 150 mg single dose followed by repeat dose. Cohort 3 and Cohort 4 were adaptive based     on the requirement of additional doses to be studies after PK data will be analyzed from each     of the first 2 cohorts.   "
123532|NCT01669070|"     The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram     (mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI     containing FF formulated with lactose. In addition, the aim of this study is to determine the     absolute bioavailability of the FF single strip product using the high strength product     administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV)     FF.      This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult     subjects. During each period, subjects will receive FF in the morning and serial     pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days     for the IV treatment) and safety assessments will be performed. Each period will be separated     by a washout period of at least 7 days and a follow-up telephone call will occur 7 -14 days     after the last dose of study drug. The total duration of the study will be approximately     13-14 weeks for each subject.   "
123533|NCT01669057|"     The objective of this study is to investigate the effect of parental peri-natal environmental     risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our     hypothesis is that the distributions of some environmental and genetic risk factors     significantly differ between neonates with and without CHD.   "
123534|NCT01669044|"     The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic     qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be     easily roused, these advances shows dexmedetomidine may be a effective and safe sedative     agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics     (such as bradycardia, hypotension), the investigators want to further research the effects of     dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance     Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely     effects like bradycardia and hypotension, so the investigators want to compare the effect of     dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to     further research the mechanism of haemodynamics of dexmedetomidine.   "
123535|NCT01669031|"     Unreliability and visual field variability is a known problem with automated perimetry in     both developing and developed country settings. This study will look at the effects of a     computer program that allows new patients to practice the visual field exam before taking the     actual exam. Our hypothesis is that the intervention group will have less variability as     measured by mean deviation between exams and greater reliability as measured by the standard     unreliability indexes of false positive rate, false negative rate, and fixation losses.   "
123536|NCT01669018|"     Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of     nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a     relevant technique in patients with severe cardiac comorbidity. The technique is a safer     alternative compared to general or spinal anesthesia in these fragile patients.      The most recognized technique with ultrasound guidance (Karmakars technique) is technically     demanding and based on injection of local anesthetic relatively close to the exit of the     spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal     prompting a risk of low blood pressure. This may be fatal in high risk patients.      The investigators have developed a simple technique based on injection away from the spinal     canal. The investigators expect minimal risk of spread of local anesthetic to the spinal     canal with this technique.      This randomized, double blinded trial compares the new technique to the established technique     of ultrasound guided blockade of the lumbar plexus.      The hypothesis is that the new technique has a higher success rate with reduced effect on     blood pressure for ultrasound guided lumbar plexus block compared to the established     technique.   "
123537|NCT01669005|"     Objectives: Invasive infections are the leading cause of morbidity and mortality in patients     treated for hematological malignancies. Blood cultures are often negative in neutropenic     patients because of low-burden of organisms, previous antibiotic therapy or non-infectious     reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.      Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before     febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for     multiplex PCR at admission and 3x/week thereafter until discharge or recovery from     neutropenia   "
123670|NCT01667250|"     The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled     pilot study is to study feasibility and collect preliminary clinical data related to the     safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the     GammaCore device for the prevention of chronic migraine, and to support the development and     approval of a larger pivotal study.   "
123722|NCT01666574|"     This study is to determine if two breakfasts of equivalent calories, an oat based breakfast     cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also     determine if the two calorically equivalent oat-based breakfast cereals give different     caloric intakes at a lunch meal that participants will eat to their satisfaction.   "
123538|NCT01668992|"     The study will evaluate the impact of a family-based intervention on the well-being of     Burmese migrant and displaced children and families living in Tak province, Thailand. The     methodology used in the impact evaluation study is a randomized waitlist controlled trial.      The study hypothesizes that participation in a family-based intervention will lead to     improved parenting practices and child and family outcomes, as follows.      Primary hypotheses:        1. Parents/caregivers participating in the family-based intervention will report increased          knowledge and use of positive parenting skills compared to control;        2. Parents/caregivers participating in the family-based intervention will report less use          of physical punishment and other harsh forms of discipline compared to control;        3. Parents/caregivers and children participating in the family-based intervention will          report higher levels of family functioning and cohesion compared to control.      Secondary hypotheses:        1. Parents/caregivers and children participating in the family-based intervention will          report lower levels of externalizing and internalizing child behaviors compared to          control;        2. Parents/caregivers and children participating in the family-based intervention will          report higher levels of child resilience and psychosocial well-being compared to          control;        3. Parents/caregivers participating in the family-based intervention will report lower          levels of alcohol use compared to control.   "
123539|NCT01668979|"     The study is aimed to assess a new system for the automatic detection, quantification and     treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The     system is comprized of a treadmill and a virtual reality simulation which provides a     motor-cognitive challenge to provoke NF. The challenges provided by the system are     individualized and using machine learning algorithms will enable the identification and     detection of NF under different conditions and allow for the most suitable treatment.   "
123540|NCT01668940|"     The primary objective of this study is to assess the effectiveness of Lillipops in the     improvement of morning sickness symptoms. Secondary objectives are to assess if there are any     changes to concurrent symptoms that may intensify NVP, such as metallic taste or     gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas), as well as     preference for freezie flavours.   "
123541|NCT01668927|"     The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone,     amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these     three antimicrobials was rare. It is necessary to assess the efficacy and safety of these     four bismuth-containing quadruple regimens with above antibiotics as empirical rescue     therapies for H. pylori eradication.   "
123542|NCT01668914|"     In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is     another important lymphatic channel of the breast. The status of IMLNs also provides     important prognostic information for breast cancer patients. The technical evolvements of     sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for     assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was     performed in the patients with clinically negative axillary nodes. However, previous     published studies concerning patients with breast cancer who all underwent a radical     mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary     metastases. For this reason, IM-SLNB is even more important for clinically axillary     node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early     breast cancer patients with clinically positive axillary nodes.   "
123543|NCT01668901|"     In this study, the investigators examine whether aspirin or warfarin is useful for atrial     fibrillation patients with chronic kidney disease.   "
123544|NCT01668888|"     Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders     such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue functions as     a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in     target tissues, that has pro-inflammatory or anti-inflammatory activities. Progranulin and     CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to clarify     the clinical meaning of these two adipokines in the subjects with or without metabolic     syndrome   "
123545|NCT01668875|"     The purpose of this study is to explore acute hemodynamic and ventilatory responses to     head-down 30 degree postural drainage position in patients with blunt chest and/or abdominal     injury in the traumatic intensive care unit.   "
123546|NCT01668862|"     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of     human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study     is being conducted in 2 centers in India. The primary end points are Visual Analog Score     (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is     improvement in ultrasonography form randomization to End of study.   "
123547|NCT01668849|"     This study will evaluate the ability of grape exosomes, given to the subject as grape powder,     as an important anti-inflammatory agent to reduce the incidence of oral mucositis during     radiation and chemotherapy treatment for head and neck tumors.   "
123548|NCT01668836|"     Women have a natural protection that gives them greater longevity. One hypothesis most     commonly used is the estrogen protection in the premenopausal period. However many studies of     various forms of hormone replacement therapy proved ineffective in promoting additional     protection for women. Thus, it is discussed other ways of protection associated with     longevity in women. Of these, the sirtuin system was found in several animal studies to be     associated with longevity. This system also showed, through the involvement of several     metabolic pathways, an important protection against the process of atherosclerosis. But the     activity of this system in humans is unknown and if it is more active in women than in men.     The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55     to 65 years, and their influence on the main metabolic pathways related to longevity and the     process of atherosclerosis. The research protocol includes analysis of the influence of     sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of     inflammation and homeostasis, before and after the interventions with caloric restriction or     resveratrol administration. It is expected of this study mechanistic conclusion for longevity     and possible clinical applications in the mechanism of atherosclerosis prevention.   "
126151|NCT01633853|"     It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the     Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3     (Rocaltrol) in the patients with CKD stage 3-5.   "
123553|NCT01668771|"     Background:      - Self-affirmation is the process of reflecting on values that a person considers important.     This process may encourage people to be more open to information about health risks. It may     also encourage them to change their behaviors or lifestyle to decrease these health risks.     Researchers want to look at the effect of self-affirmation on people s responses to new     health risk information. Because recent studies have linked alcohol consumption to increased     risk of breast cancer, the study will focus on alcohol s link to breast cancer.      Objectives:      - To study how self-affirmation can change opinions following a message about a health risk.      Eligibility:      - Women at least 18 years of age who drink at least two alcoholic beverages per week and/or     at least three alcoholic beverages per sitting.      Design:        -  Participants will be recruited through an online panel. The study will be conducted          entirely online.        -  Participants will respond to two short studies. The first will ask about life events and          how they make people feel. The second will look at how people respond to information          about alcohol and breast cancer.        -  For the first study, participants will write a paragraph or two about an important event          in their lives. They will answer questions about how that event made them feel. They          will also write a paragraph about an important personal value.        -  For the second study, participants will read information about alcohol and breast cancer          risk. They will then answer questions about this information. They will also answer          questions about their beliefs about alcohol and breast cancer.        -  Participants will receive financial compensation for being in this study.   "
123554|NCT01668758|"     Background:      - The amount of blood flowing in brain areas goes up when those areas are being used for     activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a     common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also     be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI.     Researchers want to compare fMRI and NIRS to see whether they give similar results. These     studies will be used to look at people who have had a traumatic brain injury.      Objectives:      - To test how well NIRS measure changes in blood flow in the brain after a traumatic brain     injury.      Eligibility:        -  Individuals between 18 and 60 years of age who have had a traumatic brain injury.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Researchers may          ask to see brain images during from previous MRI scans.        -  Participants will have a NIRS scan of the brain. They will be asked to do certain tasks          while inside the scanner. These tasks will involve responding to images that appear on a          screen.        -  Treatment will not be provided as part of this study.   "
123555|NCT01668745|"     Background: All observational studies and a few randomised controlled trials (RCT) suggest     that early measles vaccine (MV), in particular an early two-dose strategy, has a much better     effect on overall mortality than later MV. These results suggest that MV has a non-measles     related beneficial effect on child survival.      Objective: To evaluate in a multi-center RCT the effect on child survival and other health     indicators of a two-dose measles vaccination schedule by providing an additional dose of     Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard     measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and     Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site     separately and a 32% reduction overall. Based on the results from the RCT, the investigators     will assess the cost-effectiveness of the intervention.      Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance     System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and     campaign vaccinations will be collected regularly through home visits and health centre     registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3),     the children will be eligible for enrollment in the trial if they are not severely ill.     Eligible children will be invited to take part in the trial. Provided parental informed     consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9     months. Cost estimates will be based on consumption of services and average cost per unit.     The incremental cost effectiveness ratio will be calculated.      Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each     site the investigators intend to enroll at least 4050 children in Burkina Faso. The children     will be followed for survival and hospitalisations to 3 years of age or to the end of the     study after three years. The investigators will analyse the effects by site and combined; by     sex and season; possible interactions with other interventions like campaigns with drugs,     vaccines or micronutrients will be explored.      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of     maternal antibody levels on subsequent antibody responses to MV. The children will be     followed to 24 months of age and samples collected at 4, 9 and 24 months of age.   "
123556|NCT01668732|"     Heroin addiction has emerged as a serious problem with tremendous impacts on the addicts and     the society. Since the introduction of opioids substitutive treatment in 2006, more than     30,000 heroin addicts had received treatment, and nearly 12,000 continued on treatment     currently. However, an unknown proportion of patients hidden in community remained     un-treatment. To motivate the community heroin addicts is thus a challenging task.      It is suggested that decision making deficit is core feature which determine outcomes and     treatment motivations in patients with addiction disorders. Recently, the state-of-the-art     development of epigenetics uncover that environmental modification, via altering level of DNA     methylation and gene expression will influence on neurocognitive functioning.      Via respondent-driven sampling, this study aims to recruit a representative sample targeting     at the hard-to-reach community heroin addicts. The goal of this study is to identify the     clinical feature as well as decision making-related neurocognitive deficit in these patients.     Moreover, the investigators will explore the interplay of clinical features, DNA methylation     and gene expressions on opioids receptor genes. The findings will help to clarify the     clinical characteristics of community heroin addicts, to uncover the links between DNA     methylation and clinical features of heroin addiction and to develop modifiable treatment     targets in the future.   "
123557|NCT01668719|"     This partially randomized phase I/II trial studies the side effects and best dose of     elotuzumab and to see how well it works when given together with lenalidomide, bortezomib,     and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely     to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth     of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill     cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving     elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to     block cancer growth.   "
123672|NCT01667224|"     Obesity is a major health issue worldwide; there is a constant raise in obesity related death     each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent.     However, the efficacy and safety of Actiponin supplementation on body weight regulation in     humans are lacking.   "
123558|NCT01668706|"     Opioid abuse is a complex problem, which not only impacts on addicts' physical and     psychological health individually, but also threats the society. Recently, spread of HIV via     sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious     public health problem all over the world. In Taiwan, since the first HIV-infected IDU     identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the     epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with     Department of Justice and implemented harm reduction programs in 2005. It is the milestone     that opioid addiction is officially treated as a health rather than a legal issue in Taiwan.     Among the harm reduction programs of needle and syringe exchange for IDUs as well as     substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one of     the most important parts. Till 2008, there were over 13,000 heroin addicts participated in     more than 80 MMT programs.      Although the clinical evidences have proven the superior effectiveness of maintenance therapy     in ameliorating illicit substances abuse, decreasing criminality and improving quality of     life, there are common problems of sleep disturbance and neurocognitive impairments among the     subjects receiving opioid medications. The concerns of the adverse effects might thus     frustrate the subjects' motivation and compliance to maintain treatments. However, sleep     disturbance and neurocognitive impairments related to opioid medications are often neglected     in the clinical practices and there are scanty researches focusing on these crucial issues in     the existing literature.      In this prospective study, four groups of subjects including methadone maintenance treatment,     buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers will be     enrolled. Via the comprehensive assessments including clinical interview, neurocognitive     examinations, electrocardiogram-based sleep breathing detector and pharmacogenomical     evaluation, we will not only have the opportunities to have more insights on the impacts of     opioid medications on sleep and neurocognitive performances, but also develop more adequate     strategies to improve motivation and outcome in treating the opioid addicts.   "
123559|NCT01668693|"     The purpose of this study is to demonstrate the clinical efficiency of the Endometrial     Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure     (RIF), leading to the new concept of the personalized window of implantation (pWOI) as     diagnostic and treatment of patients with RIF of endometrial origin.   "
123560|NCT01668680|"     Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy     which may be toxic +/- exhausting are candidates for an effective and more convenient     maintenance treatment.      Objectives:        1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM)          regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.        2. To discover predictive factors for response to this LDM regimen.      Hypothesis:        1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM          chemotherapy.        2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation          of certain enzymes in the tumor may discover predictive factors of response to LDM          chemotherapy in metastatic CRC patients.   "
123561|NCT01668667|"     Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently     approved in the United States for the treatment of adults with moderate-to-severe primary     Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability,     and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of     600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS.     This study is being conducted as a post-marketing commitment (PMC) as a condition of the     approval of HORIZANT tablets (NDA 022399).   "
123562|NCT01668654|"     The purpose of this study is to evaluate the long-term safety and tolerability of     retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset     seizures (12 to < 18 years old) or Lennox-Gastaut Syndrome (12 to <30 years old) who have     participated in a previous (parent) study.   "
123563|NCT01668641|"     -  Ninety patients suffering from active rheumatoid arthritis despite continued treatment          with methotrexate will be evaluated for improvement of disease activity when taking          GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.        -  During the course of the study, patients will also be examined for any side effects that          may occur, and the amount of GLPG0634 present in the blood as well as the effects of          GLPG0634 on disease- and mechanism of action-related parameters in the blood will be          determined.   "
123564|NCT01668628|"     The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal     dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and     depression over time.   "
123565|NCT01668615|"     The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are     effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).   "
123566|NCT01668602|"     Stroke is the number one cause of disability. Difficulty with walking affects most stroke     survivors. The focus of this project is to understand the effects of different methods (such     as treadmill walking and electrical stimulation) that can be used to improve walking in     people with stroke. In this study, patients with stroke and healthy people who have not had a     stroke will be tested. Study participants will take part in walking evaluation and training     sessions. Walking patterns will be measured using automatic cameras and standard clinical     tests. Also, magnetic brain stimulation maybe used to measure brain-muscle connections, and     muscle stimulation may be used to measure spinal-cord circuits during the training. This     research will provide information on how different factors that affect walking in stroke     change with walking training. The investigators hypothesize that improvements in brain     excitability of the muscles targeted by walking training will occur after training, and these     changes in brain excitability will be related to improvements in walking patterns. By     improving our understanding of walking rehabilitation, this study can help improve walking     function and disability in people with stroke.   "
123567|NCT01668589|"     The main objective of this observational study was to describe medication-taking behavior of     patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.   "
123591|NCT01668277|"     Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in     the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand     the circulating volume, thus allowing more blood to flow and reducing pressure in the artery,     vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce     both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular     resistance decreases more or to the same degree as the systemic resistance, infusion of     hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The     primary objective of this study is to investigate how a clinically relevant dose of     hypertonic saline affects the systemic and pulmonary circulations in children undergoing     cardiac catheterization during general anesthesia. This study hypothesizes that an infusion     of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than     the systemic vascular resistance.   "
123568|NCT01668576|"     The major limitation to long term survival in lung transplant recipients is the development     of graft failure over time, termed bronchiolitis obliterans. The conventional therapies used     to prevent rejection are not effective in preventing bronchiolitis obliterans. Therefore, new     therapies are needed to address this problem. A growing body of research has focused on a     unique population of bone marrow cells termed Mesenchymal Stem Cells (MSCs) to improve a     range of medical conditions including heart failure, autoimmune disease, and inflammatory     bowel disease. MSCs can prevent animal models of bronchiolitis obliterans. Because of this     information, it is plausible that MSCs could help patients as a potential treatment in lung     transplantation.      This proposal will test the immunologic properties of MSCs generated from such individuals to     answer the question of whether generation of whether it would be feasible to use such cells     in the future to prevent entities such as bronchiolitis obliterans.      The Investigator will approach patients who are being considered for a lung transplant     because of end stage lung disease. Enrolled patients will undergo a bone marrow aspiration     where a small amount of fluid is removed from their pelvic bone. Cells obtained in this     procedure will be expanded in the Emory/Georgia Tech Cell Lab. MSCs will be expanded in this     lab using cell culture conditions which are standardly used for MSCs.   "
123569|NCT01668563|"     The purpose of this study is to compare the clinical outcome of surgical clipping and     endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT     Study.   "
123570|NCT01668550|"     The purpose of this study is to determine the maximum tolerated dose of the oral Src/Abl     inhibitor AZD0424, and to find tolerable and effective AZD0424 combination regimens for the     treatment of advanced solid tumours   "
123571|NCT01668537|"     A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and     safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox     vaccine in vaccinia-naïve healthy subjects   "
123572|NCT01668524|"     This single-site, dose-escalation study will evaluate safety and tolerability of increasing     concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular     Hypertension   "
123573|NCT01668511|"     To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with     osteoarthritis of the knee.   "
123574|NCT01668498|"     80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab)     experience skin toxicity, mostly acne like skin rash.      A standardized treatment of skin rash is neither established as standard arm for clinical     trials nor as guideline for the treatment of skin toxicity in clinical practice. While an     improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best     supportive care the data basis for patient related outcomes regarding skin toxicity deriving     from randomized trials is still small.      Recent surveys among German oncologist revealed that physicians are reluctant to use oral     antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are     thinking about using preemptive treatment in patients with acne-like skin rash.      Thus, in the present trial two main questions will be addressed:      (i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment     strategy (i.e. local treatment with erythromycin followed by doxycycline in case of     inefficacy = development of acne) without compromising treatment efficacy of skin toxicity     treatment? (ii) Comparison of general and skin related QoL between both treatment arms.   "
123575|NCT01668485|"     Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic     control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if     insulin independence is not achieved. However, the extent and underlying metabolic pathways     of this improvement are unknown. Investigators therefore compare systemic glucose turnover     including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring     islet transplant recipients, matched type 1 diabetic subjects who did not receive islet     transplantation, and matched healthy non-diabetic subjects.   "
123576|NCT01668472|"     Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as     compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart     review after delivery.   "
123577|NCT01668459|"     A study for patients with confirmed locally advanced or metastatic Transitional Cell     Carcinoma of the bladder or upper urinary tracts who have developed progressive disease     within 12 months of their platinum based chemotherapy. The study aims to compare the overall     response rate of cabazitaxel treatment versus best supportive care including single agent     chemotherapy.   "
123578|NCT01668446|"     The target of this study was an estimate the result of sildenafil on ultrasonographic     endometrial thickness, endometrial pattern investigation estrogen level on the day of     progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo     transfer cycles .   "
123579|NCT01668433|"     The emergence of partial artemisinin resistance in Plasmodium falciparum on the Cambodia-Thai     border and more recently on the Myanmar-Thai border jeopardizes the renewed global efforts of     control and elimination of malaria. Containment of this severe threat requires reduction of     transmission of the resistant phenotype by adding gametocytocidal drugs to the treatment of     falciparum malaria. Mathematical models also predict that transmission blocking will be     required if the goal of malaria elimination is to be achieved. The only drug currently     available with strong gametocytocidal properties against the more mature gametocytes is     primaquine. However, the oxidative properties of primaquine readily causes acute haemolysis     in glucose 6 phosphate dehydrogenase (G6PD) deficiency, the degree of which appears to be     inversely related to G6PD enzyme activity. Because of these safety concerns, primaquine is     not widely deployed in treatment regimens for falciparum malaria, even in areas with     documented artemisinin resistance. Methylene blue, which does not exert its action through an     oxidative mechanism, is a promising alternative as a gametocytocidal adjuvant to artemisinin     combination therapies (ACTs). Paul Ehrlich discovered methylene blue as the first synthetic     drug ever to treat malaria. In contrast with primaquine, the thiazine dye methylene blue     asserts its properties as an oxidizing agent only at very high doses, whereas at     pharmacologic doses it has reducing agent properties and is for this reason used as a     medication for the treatment of methemoglobinemia. A recent laboratory study identified     methylene blue as a potent inhibitor of gametocyte development across all stages, almost     fully abolishing P. falciparum transmission to mosquitoes at concentrations readily     achievable in humans. In addition, a recent clinical study in 180 children with uncomplicated     falciparum malaria in Burkina Faso showed that, compared to artesunate-amodiaquine alone,     addition of the cheap drug methylene blue to either artesunate or amodiaquine importantly     reduced gametocyte carrier rates measured at days 3, 7, and 14 of follow-up. This effect was     seen both in patients with and without P. falciparum gametocytaemia at baseline. The current     series of studies will investigate further methylene blue as a potential gametocytocidal drug     in the treatment of uncomplicated falciparum malaria.   "
123580|NCT01668420|"     The thermal stimulation have been proven effective in upper extremity of stroke patients.     Therefore, this study explored the efficacy of thermal stimulation in lower extremity of     stroke patients.   "
123581|NCT01668407|"     The effectiveness of non-pharmacological treatment on gait impairment on Parkinson Disease     (PD) such as exercises has been demonstrated; in particular an example for patient tailored     exercises is physiotherapy. The goal of physiotherapy treatment is to enable PD patients to     maintain their maximum level of mobility, activity, and independence. Several systematic     reviews and clinical studies have shown that physical therapy can contribute to minimize the     disabling effects of motor and sensory impairments in order to enhance participation in     societal roles and quality of life. The use of electromechanical devices such as treadmill     training (a supplement to conventional therapies) in the last years has also been used with     PD patients and a systematic Cochrane has been conducted by Mehrholz in 2010 to assess the     effectiveness and acceptability of treadmill training in the treatment of gait disorders for     patients with PD. In the last years new robotic assisted device can be used in gait training     in neurological disorder. Till now only few studies, have focused on the effects of     exoskeleton or end effector robot-assisted training in PD patients, with a interesting     preliminary results.   "
123582|NCT01668394|"     Background: It is well known that cardiac rehabilitation has potential to reduce morbidity     and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the     effect of a new patient education method called learning and coping strategies to that of     standard care.      Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly     hospitalised with either ischaemic heart disease or heart failure.      Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation     with addition of learning and coping strategies which include participation of experienced     patients as co-educators, clarifuing interviews, and inductive teaching style.      Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.      Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle,     health related quality of life.   "
123583|NCT01668381|"     The purpose of this study is to determine the enumeration and function changes of regulatory     t cells in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks     after ablation therapy.   "
123584|NCT01668368|"     Patients with acute respiratory failure exhibiting decreased respiratory system compliance     with hypoxemia or carbon dioxide retention are often difficult to ventilate with current     guidelines that limit applied plateau pressure Yet, these guidelines do not take into     consideration chest wall mechanics. The investigators sought to determine whether partition     of the respiratory system into its components by measuring esophageal pressure and thus     assessment of pleural pressure, would help in patients with acute respiratory failure to     identify the factors contributing to low respiratory system compliance.   "
123585|NCT01668355|"     People with serious mental illness have difficulty making good use of primary care, and die,     on average, years earlier than others in the population. The greatest contributors to this     premature mortality are medical illnesses, especially cardiovascular disease and cancer. The     Patient Centered Medical Home is a model for reorganizing primary care practice so that     healthcare is more effective, efficient, and user-friendly. It has been implemented across VA     as the, Patient Aligned Care Team (PACT). It is unclear, however, how this PACT model     applies to people whose predominant illness is treated by specialists. This is the case for     people with serious mental illness (SMI), many of whom receive ongoing treatment at mental     health clinics. To achieve optimal health outcomes in the population with SMI, it may be     necessary to adapt the PACT model so that it includes approaches that have proven to improve     healthcare in this population. This project implements an adapted SMI-PACT model, and     evaluates its effect on Veterans with SMI.   "
123586|NCT01668342|"     Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms are     common post-injury, and few MTBI patients receive treatment or follow-up for these symptoms.     Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly common form of     communication, potentially allowing for accurate assessment of symptom patterns after MTBI     and provision of basic education support . The investigators seek to assess the feasibility     of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or     admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based     symptom reports correlate with phone-based follow-up reports at 14 days and whether     additional SMS-based educational feedback alters daily symptom patterns.   "
123587|NCT01668329|"     Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its     outcome has not been improved despite the knowledge on inflammatory processes; a reason for     these lack of results may lay on the lack of data on the precise dynamics of inflammatory and     anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring     of the inflammatory process on a small group of non-immunocompromised patients. Our goal is     to obtain quality data, repeated over time, by limiting the technical variability.   "
123588|NCT01668316|"     The purpose of this study is to determine the effectiveness of a worksite diet and exercise     program on weight loss in postpartum women.   "
123589|NCT01668303|"     The objective of the proposed study is to adapt and implement an efficacious adolescent     substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug     court service system. Additionally, the investigators will also examine the extent to which     MDFT can enhance the effectiveness of existing juvenile drug court services in terms of     decreasing drug use, delinquent behavior and arrests and improving school and vocational     outcomes. The study design is a fully randomized controlled trial.   "
123590|NCT01668290|"     Patients who present with chest pain are investigated with tests designed to confirm or     exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor     outcome. It is not known which imaging test would be best when used first for investigating a     patient presenting with exertional chest pain. This trial is designed to compare outcomes of     the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot     study. Patients with no history of coronary disease presenting with chest pain will be     randomly assigned to one of the three test modalities as the initial imaging test. The three     imaging strategies will be compared regarding the subsequent use of healthcare resources over     a year.   "
123673|NCT01667211|"     Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis     cervical cancer, to evaluate the efficacy and toxic reaction.   "
123592|NCT01668264|"     Diastolic function is poorly studied in children with congenital heart disease. This is     mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to     echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue     characterization. The main advantage of echocardiography is a better temporal resolution     which allows the study of short events like early relaxation. Overall there is a lack of     studies correlating different echocardiographic and MRI parameters of heart function in     pediatric populations with congenital or acquired heart diseases. This study will address     specific questions on specific groups of patients that might bring more insight into chamber     interaction and cardiac function. This study hypothesizes the following:        -  Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo          might be the best method for follow-up.        -  Cardiac remodeling associated with chronic loading results in changes in diastolic          properties related to changes in cardiac mass and volume. This is related to changes in          cardiac mechanics influencing diastolic parameters. Especially the influence on twisting          and untwisting will be studied.        -  Regional myocardial fibrosis and scarring may account for regional systolic and          diastolic dysfunction with possible prognostic impact   "
123593|NCT01668251|"     The goal of this study is to compare the features of Turner syndrome in girls who are     diagnosed before birth because of fetal concerns versus those who are diagnosed when their     mother has an amniocentesis for another reason.   "
123594|NCT01668238|"     The purpose of this stage of study is to establish discriminant among healthy tissue, benign     and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.   "
123595|NCT01668225|"     Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of     this molecule is increasing in reproduction pathology. High level of follicular and blood     G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation     rates.   "
123596|NCT01668212|"     Perifollicular Doppler could reflect the quality of the follicle's vascularization and,     consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the     analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.      The goal of this study is to evaluate if there is a link, in natural cycle In Vitro     Fertilization, between the quality of the vascularization and the one of the oocyte, the     embryo and the pregnancy.   "
123597|NCT01668199|"     A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.   "
123598|NCT01668186|"     The Peroxisome Biogenesis Disorders (PBD) are a group of inherited disorders due to defects     in peroxisome assembly causing complex developmental and metabolic sequelae. In spite of     advancements in peroxisome biology, the pathophysiology remains unknown, the spectrum of     phenotypes poorly characterized and the natural history not yet systematically reported. Our     aims are to further define this population clinically, biochemically and genetically. The     investigators will prospectively follow patients from Canada, the US and internationally, and     collect data from medical evaluations, blood, urine and imaging studies that would be     performed on a clinical care basis. Patients unable to attend clinics can participate in this     study by mailing in their medical information. The investigators will use this information to     identify standards of care and improve management.   "
123599|NCT01668173|"     The purpose of this study is to test a new drug called AUY922. AUY922 is not FDA-approved.     AUY922 is a new kind of drug that attacks a protein called HSP90. HSP90 is found in both     normal and cancer cells, but the investigators think it is more important in cancer cells.      This study will see if AUY922 helps people with myelofibrosis, essential thrombocythemia and     polycythemia vera. This study will also see if AUY922 is safe in people with myelofibrosis,     essential thrombocythemia and polycythemia vera. It will find out what effects, good and/or     bad, AUY922 has on the patient and the disease. The researchers hope that this study will     help them to find better treatments for primary myelofibrosis, essential thrombocythemia and     polycythemia vera.   "
123600|NCT01668160|"     The specific aim is to quantify the stability of the acetabular and femoral components of a     revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In     this way, the investigators will gain insight into the outcome of the current state of the     art of revision arthroplasty surgery. In the past, acetabular and femoral component stability     has been measured using radiostereometric analysis (RSA) and when patients having revision     total hip operations were compared to patients undergoing primary total hip operations it was     possible to determine differences in stability and this was predictive of the intermediate to     long-term performance of the acetabular and femoral reconstruction. The investigators propose     to use this established, high resolution technique to assess and compare the stability of the     revision implants.   "
123601|NCT01668147|"     The purpose of this research study is to determine the effects of ritonavir and efavirenz on     the activity of P-glycoprotein in human brain.      Screening      Health self-assessment and undergo a medical history and physical examination, including a     structured interview to screen for history of medical conditions, fasting blood glucose and     HIV blood tests, urine HCG pregnancy test for women of childbearing potential will be     performed within 24hr of study drug administration      Study visits Subjects will be studied on three occasions, with a washout between sessions.     Sessions 1: Control (no pretreatment) - intravenous administration of 10 - 14 mCi of [11C]     desmethyl-loperamide (dLop) with PET/CT imaging Session 2: Pretreatment with oral ritonavir     for 3 days followed by intravenous administration of 10 - 14 mCi of [11C]dLOP with PET/CT     imaging Session3: Pretreatment with oral efavirenz for 14 days followed by intravenous     administration of 10 - 14 mCi of [11C]dLOP with PET/CT imaging   "
123602|NCT01668134|"     This study is being done to determine if targeted radiation therapy (stereotactic) can be     given to treat liver cancer, for patient who are unable to undergo surgery, over a short     period of time with a small amount of side effects.   "
123603|NCT01668121|"     The primary objective of this study is to evaluate the acceptance range with which two     Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The     secondary objective is to compare pharmacokinetic parameters of the reference product batches     and Budesonide/formoterol Easyhaler.   "
123718|NCT01666626|"     The purpose of this study is to determine whether ultrasound-based assessment of intestinal     stiffness in patients with Crohn's disease predicts the effectiveness of medical therapy or     the need for surgical resection.   "
123604|NCT01668108|"     The main purpose of this observational study with Paclitaxel is to determine the number of     treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special     circumstance of ambulant chemotherapy.      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted     packaging sizes as to decrease the excess quantity to be discarded follows also this     objective.      Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison     to Docetaxel. To this purpose, data regarding co medications and adverse events are also     collected.   "
123605|NCT01668095|"     This research trial studies tumor tissue to identify important proteins and biomarkers from     patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot     be cured or controlled with treatment. Studying samples of tumor tissue from patients with     cancer in the laboratory may help doctors identify biomarkers related to cancer.   "
123606|NCT01668082|"     The study is designed to use infusion of a non-radioactive, naturally occurring isotope of     glucose (13C) in patients undergoing surgical resection for a newly identified brain mass to     obtain the metabolic phenotype of the tumor, and correlate it with the histopathological     diagnosis. In each patient, 13C NMR spectral analysis of tumor extracts will be obtained     after intraoperative infusion of [U-13C]glucose or [1,2-13C]glucose. Whenever feasible,     patients will undergo 3 preoperative imaging studies - 18FDG-PET, diffusion tensor imaging     with 1H-spectroscopy on 3T MR scanner, and ultra high resolution MR imaging on the 7T MR     scanner. The results of these imaging studies will be correlated with the metabolic phenotype     to generate a comprehensive non-invasive view of the tumor with the goal of identifying     infiltrative, metabolically active tumor cells within the brain. In addition, a comprehensive     molecular profile of the tumor will be obtained and enable a genotype-metabolic phenotype     comparative analysis.      Correlative Translational Research The investigators will obtain tumor tissue from each     patient for comprehensive molecular analysis (array CGH, expression profiling, methylation     profiling) which will be correlated with tumor histology, the metabolites identified by 1H-MR     spectroscopy and the 13Cglucose metabolic profile. Patients will be followed at designated     time points along their treatment course to obtain information about ongoing treatment and     response, time to tumor progression and overall survival. These parameters will be used in     correlational analysis with the metabolic phenotype.   "
123607|NCT01668069|"     Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in     efficacy to the combination of pyridoxine and doxylamine, the currently recommended first     line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians     and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are     using ondansetron as first line in practice. Despite this practice and the recommendations     from ACOG, there is not data to suggest that ether practice is superior. This will be the     first prospective, randomized, double blind, controlled trial comparing the two treatments.     We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes     of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely     benefit from less Emergency Department visits, urgent clinic visits, and admissions for     progression to hyperemesis gravidarum.   "
123608|NCT01668056|"     Ovarian stimulation is an important phase of in vitro fertilization (IVF) treatments. The     harvest of a larger number of viable eggs per cycle compensate eventual laboratory     difficulties and allow for the selection of embryos with higher implantation potential. In     the current protocols, based on the most prevailing theory of ovarian follicular development,     stimulation drugs are usually started on the second or third day after the beginning of     menses. The follicular phase of the menstrual cycle is believed to be the only favorable     moment for follicular development.      In the early 2000's a new model of human ovarian follicular development (follicular waves)     has been proposed based on frequent transvaginal ultrasound observations between two     ovulations. It has been shown that ovarian antral follicles develop in synchronous groups,     two to three times in a cycle. In fact the follicular wave phenomenon has been initially     described in the 80's on domestic animals, like the mare and the cow. Moreover, studies in     these animals have shown that synchronizing the start of the ovarian stimulation drugs with     the beginning of a follicular wave yields better results for assisted reproductive     treatments. Consequently in ovarian stimulation protocols for animal assisted reproduction it     is important to control the initiation of a follicular wave.      Current protocols of ovarian stimulation for IVF in women do not consider the start of a     follicular wave to begin drug administration. Therefore the purpose of this study is to     evaluate two methods to control the emergence of a follicular wave (ovulation induction and     dominant follicle aspiration) and to investigate the effects of synchronizing ovarian     stimulation for IVF with follicular wave emergence in women compared to one of the current     stimulation protocols (flexible GnRH protocol).   "
123609|NCT01668043|"     The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting     the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective     when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected     adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. The     neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive     cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1     infection.   "
123622|NCT01667874|"     The purpose of this study is to determine if Collatamp, a small flat sponge soaked with     antibiotics will help to improve the success rate of the treatment of acute joint infections     after a joint replacement surgery. Our hypothesis is that those patients receiving the     Collatamp sponges will have an improved success with respect to the eradication of infection     at one year following treatment.   "
123623|NCT01667861|"     The purpose of this study is to determine the impact of playing wind instruments for the     development of ocular hypertension and glaucoma, together with investigating the prevalence     of visual problems and eye diseases in (professional) musicians.   "
123624|NCT01667848|"     The purpose of this study is to determine the effect of warmed, humidified carbon dioxide     Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.   "
123719|NCT01666613|"     The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is     administered in different ways - orally, intravenously or inhaled (with two different     devices), to healthy subjects   "
123610|NCT01668030|"     Forty percent of patients admitted to the contributing regional burn unit over a five month     period received facial burns (n=14). The purpose of this study is to examine if the time     until a granulation bed is well established can be decreased be using an enzymatic agent,     when compared to a second standard ointment, for patients with partial-thickness facial     burns. The current study will use a prospective, experimental study design in which each     individual will be their own matched control. That is, each individual will receive both the     experimental ointment (one-side of the face) and the standard ointment (other-side of the     face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation     bed establishment) one ointment achieves in partial-thickness facial burns when compared to a     second ointment. Exploratory analyses will examine the relationships among demographic     variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That is,     testing whether the time until granulation establishment may be associated with an     individual's demographic variables, treatment type, pain, anxiety, itching levels, and     scarring. Significance for all analysis will be at the 0.05 level. The investigators     hypothesize that promoting rapid granulation bed establishment will decrease hospital length     of stays, costs, risk of infection, and possibly associated appearance changes. The results     from the current study will provide preliminary findings for a future, more sophisticated     study.   "
123611|NCT01668017|"     This is a two-part trial. Solid tumor in this protocol means solid tumor excluding     hepatocellular carcinoma (HCC).      Part 1: Dose Escalation Phase in subjects with solid tumor (Cohort A) and HCC (Cohort B). The     dose will be increased from 45 mg twice a day (BID) with 3+3 cohort method up to the     recommended phase 2 dose (RP2D) of pimasertib established as single agent in the global     studies for each arm independently.      Part 2: The Maximum Tolerated Dose (MTD) defined in Part 1 will be confirmed in more subjects     in Cohort A (N=18) and Cohort B (N=6) separately.      Following the recommendation by the Safety Monitoring Committee, Cohort B was discontinued     due to hepatocellular carcinoma (HCC) and there will be no further enrollment of subjects to     this cohort. This decision is based upon review of safety and efficacy information.   "
123612|NCT01668004|"     The objective of this study is to determine the difference in the annual incidence rate of     uveitis attacks in participants with ankylosing spondylitis (AS) before start initial     anti-TNF therapy and after treatment with golimumab (GLM).   "
123613|NCT01667991|"     Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve     the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are     different between countries, will affect the accuracy of etiological diagnoses according to     the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the     accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria     in China.   "
123614|NCT01667978|"     The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower     levels of a birth control medication called norethindrone. Norethindrone (also called the     mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth control     pill used to prevent pregnancy. Norethindrone is the standard medication used in women who     take the progestin only pill to prevent pregnancy. There are other birth control pills which     contain different medications. The investigators want to learn if HIV medications (atazanavir     and ritonavir) make the blood level of this birth control pill higher or lower. If the levels     of norethindrone are too low it may not work to prevent pregnancy. The investigators also     hope to learn about changes in the vaginal fluids and cervical fluids when women are taking     this birth control pill.   "
123615|NCT01667965|"     The purpose of this study is to assess the effectiveness and acceptability of a recently     created informative video geared for patients who have been evaluated by a radiation     oncologist for palliative radiation therapy during a hospitalization at Memorial     Sloan-Kettering Cancer Center. Palliative radiation therapy is radiation therapy that is     given to patients with the purpose of easing symptoms from cancer. It is not given with the     intent to cure the cancer. The video presents basic information about palliative radiation     and palliative care.   "
123616|NCT01667952|"     The purpose of this study is to establish a registry of survivors of cancer, tumor, or a     related illness.   "
123617|NCT01667939|"     Nuclear factor kappa B (NF-κB) pathway and oxidative stress participate in endothelial     dysfunction, which is one of the causes of preeclampsia. Among the human antioxidant     mechanisms there are the enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide     dismutase (SOD). Our aim was to measure NF-κB and oxidative stress in pregnant women     submitted to an individualized diet during pregnancy.   "
123618|NCT01667926|"     Ketamine infusions resulted in an acute reduction in global depression scores and in severity     of suicidal ideation. The investigators therefore plan to investigate the feasibility and     efficacy of repeated intravenous administration of ketamine in severely depressed, treatment     resistant patients. The results of the study could lead to development of new strategies for     treating depression.   "
123619|NCT01667913|"     The purpose of this study is to examine the relative (ICC) and absolute intertester     reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient     facility. The data collection is conducted by two physiotherapists, who are blinded to each     other. The physiotherapists are randomized so they each are doing an equal number of baseline     tests.   "
123620|NCT01667900|"     This is a study of dulaglutide in Chinese participants. The purpose of the study is to     determine how the body processes dulaglutide and how dulaglutide affects the body. This study     has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of     3 study periods. There is a minimum 28-day washout between periods. Part A will last     approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants     with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.      Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this     study.   "
123621|NCT01667887|"     The objective of this study is to document callus formation and healing of fractures     stabilized with locking plates utilizing modern MotionLoc screws that provide controlled     axial micro-motion to actively promote fracture healing.   "
123645|NCT01667575|"     The purpose of this study is to observe the efficacy of ten day triple therapy-based,     bismuth-containing quadruple therapy for H.pylori treatment.   "
123625|NCT01667835|"     The purpose of this randomized, control pilot study is to measure the effects of a gentle, 12     week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk for     cardiovascular disease. Hatha yoga is a form of structured physical exercises known as     asanas, combined with breathing exercises called pranayama, and relaxation techniques. The     yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing     exercises (pranayama) that can be easily replicated and readily performed by individuals who     are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.   "
123626|NCT01667822|"     Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from     mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy     (CBT) has been shown to be an effective treatment of these disorders. Despite the strong     evidence for CBT there is a lack of evidence-based psychological treatment in primary care.     For various reasons, the progress of research has not affected clinical practice. For     successful implementation of CBT in primary care cost-effective therapies, access to     therapists with proper training and supervision, evidence-based manuals and management that     support the implementation is needed.      Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All     patients are first treated with self-help CBT (N = 400). Patients that do not improve after     treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based     on published studies 2/3 is expected to be improved after self-help and therefore do not     undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to     individual CBT (N = 67) or continued self-help treatment (N = 67).   "
123627|NCT01667809|"     Background: Common mental illness, such as anxiety disorders and depression, is the main     cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be     effective in alleviating target symptoms of these disorders, but its effect on sick leave     rates has not been sufficiently addressed. The investigators have developed an intervention     called return to work (RTW), which is based in cognitive behavioral theory, that has a     primary aim of helping sick-listed patients with common mental illness return to work. This     new treatment has not been evaluated in a randomized controlled trial.      Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical     common mental illness in a randomized controlled trial conducted in primary care.     Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes     are days of sick leave and clinician severity rating of psychiatric symptoms. This study     could contribute to new knowledge regarding how to best treat patients on sick leave with     mild common mental illness.   "
123628|NCT01667796|"     This is a pilot study of oral vitamin D supplementation to determine if patients with     Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum     25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or     relevant gene expression response to oral vitamin D supplementation differs in patients with     MS and healthy controls.   "
123629|NCT01667783|"     Weight loss is effective in reducing many complications of obesity, with the majority of     patients who undergo bariatric surgery having substantial improvements in their     weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to     moderate obesity to compare how losing 10% of initial body weight via one of three common     weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass     surgery, and adjustable gastric banding) affects diabetes. While the investigators do not     expect this pilot study to provide definitive answers, it will provide valuable information     to design a larger trial which will help guide therapy for people with mild-moderate obesity     and substantial comorbidities.   "
123630|NCT01667770|"     This research study is to find out which types of dural grafts used during surgery for Chiari     Malformations are superior. We believe that autologous dural grafts are superior to     non-autologous grafts.   "
123631|NCT01667757|"     Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound     imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES)     implantation, were used in < 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria     satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or     not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was     proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous     studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful     predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging     criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of     this study was to investigate angiographic and IVUS parameters in which corresponding FFR and     evaluate their optimal physiologic criteria after DES implantation.   "
123632|NCT01667744|"     Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or     emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary     Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In     addition, behavioral treatment of emotional distress is known to decrease symptoms, and     treatment usage. The present protocol tests whether the addition of a medication known to     reduce emotional distress can also reduce symptoms and treatment usage.      This will done by recruiting patients with ACS during their hospital stay, randomizing them     to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6     months.   "
123633|NCT01667731|"     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)     plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are     coinfected with HIV-1.   "
123634|NCT01667718|"     To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and     without Bismuth for H.pylori treatment.   "
123646|NCT01667562|"     This open-label, multi-center study will evaluate the progression-free survival and safety of     erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with     activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor     (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or     unacceptable toxicity.   "
123647|NCT01667549|"     The goals of the proposed research are to specify the timing and consequences of the     sensitive period for flavor learning in infants who are being breastfed or formula fed. The     investigators will conduct a randomized within- and between-subject study of women and their     infants during a 15-month window.   "
123635|NCT01667705|"     -  Rationale: Recently, research that demonstrates a clear relationship between the built          healthcare environment and the health and wellbeing of patients has come available.          Patients in a CT scan suite are usually anxious. The environment has been shown to lower          stress; a painting or piece of art for example, can capture and hold attention and          thereby lower negative thoughts and evoke positive emotions. Sights of nature have          demonstrated to be especially effective in recuperating from stress, presumably because          the human brain has evolved in a natural environment. The current study will investigate          the effects of exposure to nature in the CT scan suite. A SkyCeiling, a large, slightly          illuminated, photographic illusion of a real sky view is placed above the CT scan. The          main hypothesis of this study is that a sky view will lead to a lower level of anxiety          in the CT scan suite.        -  Objective: The primary objective of this study is to examine the effect of a view of          nature on a patient's stress and anxiety. Secondary objectives are to study the effects          of a view of nature on a patient's environmental appraisals of the CT suite,          satisfaction with the provided service, and trust in the healthcare provider.   "
123636|NCT01667692|"     The Aim of this study is comparison between two regimens containing clarithromycinand     azithromycin.   "
123637|NCT01667679|"     This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through     the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine     headaches in 30 minutes after use.   "
123638|NCT01667666|"     This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a     preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human     research indicate that aerosolized salt water might help reduce harmful inflammation with     minimal risks.   "
123639|NCT01667653|"     This is randomized, double-blind, placebo controlled, single centre; 21 days phase II     clinical trial on healthy volunteers. Following baseline visit at the day of randomization,     treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic     treatment subjects will also receive the study treatment, either probiotic or placebo. Daily     Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect     fecal samples for microbiological examination. The primary objective of the study is to     evaluate the maintenance of intestinal microbiota composition during antibiotic treatment     with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects     associated with antibiotic use.   "
123640|NCT01667640|"     Microneurosurgical resection of intracerebral metastases leads to prolonged survival and     relief of symptoms in selected patients.      To minimize the risk of intracranial recurrence whole brain irradiation has been established     as standard adjuvant treatment in those patients. Sector irradiation resembles a brain -     tissue - sparing method by focusing the irradiation in the area of the tumor bed and a     surrounding 1mm security margin.      The aim of this study is to investigate whether adjuvant sector-irradiation following     microsurgical resection is equal to adjuvant whole brain irradiation in terms of local     control and superior to in terms of quality of life and neurocognitive deficits in a     prospective randomized trial.   "
123641|NCT01667627|"     We present the study design of a clinical trial designed to assess the clinical effects of     the multispecies probiotic combination BIO-25 in IBS-D patients. To this aim the primary     endpoints of the study will be improvement in abdominal pain and stool consistency. The study     will also be designed and powered to investigate the effect of the probiotic BIO-25 on the     putative inflammation-associated parameters related to microinflammation in IBS, using     postulated improvements in Hs-CRP, and calprotectin as markers of that effect. Additional     aims of the study will examine the possible effect of probiotic BIO-25 on the cholinergic     status.   "
123642|NCT01667614|"     The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin     converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both.     Recent evidence has provided robust evidence that aldostrone escape plays an important role     in this regard. It is believed that aldostrone escape occurs quite commonly with reports     indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial     of patients with diabetes and hypertension it was shown that treatment of aldostrone escape     with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number     of other trials have similarly observed that addition of spironolactone to an ACE inhibitor     based regimen provides additional benefits on proteinuria reduction, blood pressure control,     and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in     this regard are of short duration (e.g. three months), and have added spironolactone to an     ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating     efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS     blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to     determine the effects of addition of spironolactone 25 mg daily to losartan over a period of     18 months.   "
123643|NCT01667601|"     Only a few intervention studies have also focused on changing patients' negative thoughts and     feelings towards the illness and their relationship to the suffering caused by those     thoughts, which is evidenced to empower psychosocial functioning and control of distressing     thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress     Reduction program. This controlled trial is designed to test the effects of a     mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia     on their symptom severity, illness insight and psychosocial functioning.   "
123644|NCT01667588|"     Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with     a reported prevalence of 60-80%. To date three studies have reported on SDs in children with     CKD but these have all been based on questionnaire data alone. The findings were not     confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a     validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is     highly relevant given the poor sensitivity and specificity of even validated questionnaires     alone. The effect of untreated pediatric SD is pervasive. This study will provide the first     objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis.     Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially     contributing to their immediate management (eg improved control of hypertension, improved     school performance), while improving their Quality of Life (QOL) and helping ensure they     achieve their full potential.   "
123649|NCT01667523|"     An altered permeability has been proposed to play an important role in the pathogenesis of     several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel     disease. Nutrients derived from food are able to influence the permeability of the intestine     and can therefore also affect gastrointestinal symptoms. In this study, the investigators     will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot     peppers and cinnamon, respectively, on gastrointestinal physiology.      Objective:      To obtain more information about the effects of capsaicin and cinnamaldehyde on the     intestine, these substances will be infused directly in the duodenum. Hereafter, the     permeability of the intestine, gallbladder motility and the effects on satiety will be     assessed.      Hypothesis:      Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial     barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin     from enterochromaffin cells as determined by the multi sugar permeability test   "
123650|NCT01667510|"     Blood-pressure reading of 140/90 mmHg (systolic/diastolic pressure) are typically regarded as     having high blood pressure as defined in the most recent guidelines. From a physiological     perspective, the regulation of blood pressure is a complicated process involving different     biological systems and a number of feedback systems, including the nervous system, hormones,     control of body fluid and regulators within the vessels themselves. In 90-95% of patients     with high blood pressure the cause is unknown, whereas the remaining 5-10% may have secondary     hypertension related to congenital heart defects, certain cancers or kidney abnormalities.     Prehypertension [systolic blood pressure (SBP) 120-139 mm Hg, diastolic blood pressure (DBP)     80-89 mm Hg] is considered a precursor of hypertension and has been associated with an     increased risk of up to 3.5 times in cardiovascular morbidity and mortality later in life.      According the report of the Joint National Committee on High Blood Pressure (JNC 7) and other     international guidelines, weight control, reduced intake of salt and reduced alcohol     consumption, as well as increase of potassium are recommend nutritional approaches to prevent     and treat hypertension. In observational studies significant inverse association between high     blood pressure and vegetarian diet rich in fibers, magnesium, potassium, calcium and protein     have been reported. In addition various studies demonstrated the ability of antioxidant     vitamins of natural origin to improve vascular function.      The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted     Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension     compared to Placebo.   "
123651|NCT01667497|"     Multiple Sclerosis (MS) patients often complain of cognitive fatigue. There is currently no     treatment for this symptom. Fampridine SR is a recently approved medication that improves     walking ability and walking speed in MS patients. It is thought that it might have the same     positive effect on cognitive fatigue. This study will compare fampridine 10mg twice a day to     placebo in order to determine if there is any benefit of this medication for cognitive     fatigue in MS.   "
123652|NCT01667484|"     Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis     (MS) and can occur independently of physical disability. It is the most common reason, along     with physical fatigue, for MS patients to stop working. The most frequent complaint is     problems with multi-tasking or thinking quickly, which corresponds to impairment in the     cognitive domain of processing speed. Currently there is treatment available to prevent     relapses and physical disability but there are no medications that have been shown to treat     cognitive impairment. Amphetamines have been beneficial for selective attention and     processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain     injury. This is study will determine whether Adderall XR improves objective measures of     processing speed and attention in MS patients impaired in this cognitive domain, by comparing     two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is     administered. The results of this study will help provide data to design a larger study to     determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive     impairment in MS patients.   "
123653|NCT01667471|"     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who     completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical     response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra     8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.   "
123654|NCT01667458|"     This observational study will evaluate the presence and evolution of fatigue on treatment     with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis     who have an inadequate response to at least two DMARDs (one of them methotrexate) or to     anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg     intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.   "
123655|NCT01667445|"     The purpose of this study is to determine the contribution of spinal epimorph to patient's     perioperative pain management in Total Knee Arthroplasty (TKA). This study is designed to     determine whether spinal epimorph and its associated complications is a necessary addition to     provide adequate analgesia given the multimodal approach to pain management. It is     hypothesized that perioperative local infiltration with a cocktail of local and systemic     analgesics will provide equal analgesia to patients who are given both local infiltration and     spinal epimorph perioperatively.   "
123656|NCT01667432|"     This prospective, multicenter, observational study will evaluate on-treatment predictors of     response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving     treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the     summary of product characteristics. Data will be collected from patients for the duration of     their treatment and for up to 24 weeks thereafter.   "
123671|NCT01667237|"     The general objectives of this study are to verify the feasibility of a short home-based     rehabilitation program for cancer patients prior to lung resection surgery, and to quantify     its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.      Therefore, the hypotheses of this study are that:        1. Implementation of a short home-based rehabilitation program (4 weeks) based on exercise          training is feasible and safe in patients with lung cancer resection candidates.        2. Compared to control patients, patients included in the home-based rehabilitation program          will improve significantly their aerobic capacity, exercise tolerance and arms and legs          muscle force.   "
123658|NCT01667406|"     Infertility affects one in six couples in the United Kingdom (UK) and has devastating     physical, social and emotional consequences for affected couples. In vitro fertilisation     (IVF) treatment is now widely and successfully used to enable infertile couples to conceive.     However, IVF treatment can result in the potentially life threatening condition, ovarian     hyperstimulation syndrome (OHSS). Mild forms of OHSS occur in approximately 1 in 3 of all IVF     cycles, whilst approximately 1 in 10 IVF cycles result in moderate or severe OHSS. OHSS is     caused by the use of human chorionic gonadotrophin (hCG) used in IVF treatment to stimulate     oocyte (egg) maturation. Kisspeptin is a hormone which stimulates reproductive hormone     secretion and is responsible for the release of reproductive hormones which result in oocyte     maturation and ovulation (the release of an egg from the ovary). The significant advantage of     kisspeptin over current treatments to stimulate ovulation, is that it would stimulate a more     physiological increase in reproductive hormones and oocyte maturation during IVF treatment.     The aims of this project are to investigate whether administration of kisspeptin to women can     result in oocyte maturation.   "
123659|NCT01667393|"     Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the     IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive     atherosclerotic popliteal artery disease.   "
123660|NCT01667380|"     This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene     glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on     dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.   "
123661|NCT01667367|"     This single-center, single-blind, placebo-controlled, parallel-group study with crossover     component will evaluate the GABAAalpha5 receptor expression, occupancy and functional     connectivity in the brains of individuals with Down syndrome and healthy controls following     single dose RG1662. Participants will receive a single dose of placebo before the imaging     session (PET and MRI), and a single dose of RG1662 before the second imaging session.   "
123662|NCT01667354|"     The primary aim of this trial is to test the effectiveness of an intervention to train     primary care physicians to determine if it leads to decreased parental vaccine hesitancy.   "
123663|NCT01667341|"     Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts     of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each     cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:        1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)        2. GEN-003: Antigens alone        3. Placebo (DPBS diluent)      Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot     Group. Immunization of the remainder of the Group Continuation Group) is contingent upon     successful review of data from the Pilot Group through Day 7 after immunization. Dose     escalation to the next dose level Cohort proceeds after evaluation of safety data from all     patients in the prior Cohort and only after all specified safety criteria are met. The total     numbers of patients in each Group and Cohort are as follows:        -  10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)        -  30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)        -  100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)        -  Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)      Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at     3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done     twice daily for 28 days prior to the first immunization (baseline shedding), and again     following the last immunization. Follow-up for safety monitoring will be conducted for 12     months after the last immunization.   "
123664|NCT01667328|"     This randomized controlled interventional study is designed to determine whether breast     cancer surgical patients receiving presurgical massage therapy performed by a licensed     massage therapist have decreased average anxiety levels compared to the control group of     breast cancer surgical patients who do not receive massage therapy.   "
123665|NCT01667315|"     The use of ultrasound in regional anesthesia enables reduction in the local anesthetic     volume. The present study aimed to determine the minimum effective volume of 0.375%     bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery.     Following approval by the Research Ethics Committee, patients with a physical condition of I     or II according to the American Society of Anesthesiologists, between 21 and 65 years old and     subjected to elective surgery of the shoulder and interscalene brachial plexus block will be     recruited. The volume of the anesthetic will be determined using a step-up/step-down method     and based on the outcome of the preceding block. Positive or negative block results in a 1mL     reduction or increase in volume, respectively. The success of the block is defined as the     presence of motor block in two muscle groups and the absence of thermal and pain sensations     in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis,     pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will     undergo statistical analysis in order to determine minimum effective volume of 0.375%     bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function,     evaluate diaphragm paralysis and its influence in pulmonary function.   "
123666|NCT01667302|"     The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy     followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.   "
123667|NCT01667289|"     The purpose of this study is to prove the superiority of concurrent chemoradiation compared     with radiotherapy alone in patients with low risk NK/T-cell lymphoma.   "
126152|NCT01633840|"     This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be     used in blinded low-dose food challenges.   "
123723|NCT01666561|"     To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an     equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety     over the 4 hour period following breakfast.   "
123757|NCT01666119|"     This is an open label study in opioid dependent subjects maintained on a stabilized dose of     Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA     Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized     on Suboxone (buprenorphine/naloxone) tablets or films.      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.     This dose will be taken throughout the 12-week treatment period with dose adjustments as     clinically indicated for either the control of opioid dependence or adverse events (AEs).   "
123674|NCT01667198|"     Professional societies recommend that endoscopists measure their ceacal intubation rate,     adenoma detection rate as indicators of the screening colonoscopy quality. However, it is     uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in     the detection of adenomas. The investigators hypothesize that a hands-on-training     intervention tailored to the results of environmental assessment and audit on colonoscopy     quality indicators results in higher adenoma detection rate improvement than simple audit and     feedback. The investigators further hypothesize that by training the leaders of the screening     centres, the effect of the intervention will be further disseminated among other endoscopists     from the participating centers, and will thus result in additional increase in individual     adenoma detection rate.      The primary aim is to compare the impact on adenoma detection rate of two screening     colonoscopy improvement programs:        1. Tailored training intervention.        2. Audit feedback on colonoscopy quality indicators.   "
123675|NCT01667185|"     The primary objective of the study is to evaluate the safety and effectiveness of the G4     System (System) when used as an adjuvant to blood glucose testing over a 7-day period in     pediatric subjects with diabetes mellitus.      System effectiveness will be primarily evaluated with comparison to laboratory reference     Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be     evaluated in terms of point and rate accuracy of the system in reference to YSI. The point     accuracy is measured as the proportion of G4 System values that are within ±20% of YSI     reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL.     The trend accuracy of the device performance, i.e., continuous glucose error grid analysis,     will be evaluated as well as the temporal accuracy at different glucose rates of changes and     different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary     matched paired (Sensor-YSI) measurements will be collected during one in-clinic session.     System effectiveness will also be evaluated with SMBG measurements similarly.      Safety data of the system will also be collected and safety will be characterized by the     incidence of Adverse Device Effects (ADE) experienced by study participants.      Other objectives include the evaluation of device performance at an alternate site (the upper     buttocks).   "
123676|NCT01667172|"     Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein     devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.      Research questions:        1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP          values measured at the clinical laboratory?        2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable?          2.1.1. Comparison of 2 measurements in the same patient on 1 device          (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on          2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices          equally userfriendly in a general practice surgery? (userfriendliness   "
123677|NCT01667159|"     This study will examine the effectiveness of an integrated treatment for adolescents who are     depressed and use alcohol in an intensive outpatient setting in the community.   "
123678|NCT01667146|"     Some people develop the condition called acute respiratory distress syndrome (ARDS). This is     a condition where the lungs have become injured from one of a number of various causes, and     do not work as they normally do to provide oxygen and remove carbon dioxide from the body.     This can lead to a reduced amount of oxygen in the patient's bloodstream. Patients with ARDS     are admitted to the intensive care unit (ICU) and need help with their breathing by being     connected to a ventilator (breathing machine). ARDS can lead to injury in other organs of the     body causing other problems but also death.      Over the past few years, reducing the size of each breath delivered by the ventilator in     conjunction with the use of an occasional sustained deep breath called a recruitment     manoeuvre have been used to try to prevent further damage to the lungs in people with ARDS.     This ventilator strategy (termed the PHARLAP strategy) has been shown in a small research     study to have some beneficial effects without causing any obvious harm, when compared to a     current best practice ventilator strategy. The main beneficial effects of the PHARLAP     strategy were to increase the amount of oxygen in the blood and to reduce markers of     inflammation (the body reacting to a disease process) in the body. This study was too small     to make a strong conclusion, so this study will be much larger and will assess whether     patients who have developed ARDS are better off when we use the PHARLAP strategy. Three     hundred and forty patients will be enrolled into this study in multiple ICUs across Australia     and New Zealand.      The study hypothesis is that the PHARLAP strategy group will have a higher number of     ventilator free days at day 28 than the control group.   "
123679|NCT01667133|"     The purpose of this study is to assess the safety and efficacy of ponatinib in Japanese     patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or     nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine     kinase inhibitors (TKIs).   "
123680|NCT01667120|"     The general purpose of this study is to characterize the safety profile of ketorolac in     infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective     in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg     intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9%     normal saline as placebo.      Primary: The primary purpose of this study is to compare bleeding events in neonates who     receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that     ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.      Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine     output per shift, platelet counts, hemoglobin levels, number of days on the ventilator,     amount of narcotic administered, blood pressure, and reintubation events on all patients in     this study as secondary study points.   "
123681|NCT01667107|"     This single site study will examine plasma and alveolar compartment (AC) levels of     posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant     recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal     infection rates will be assessed following transplantation.   "
124001|NCT01662713|"     The purpose of this research study is to find out if a non-invasive imaging device called     Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels     that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details     of your skin without needing to use any invasive techniques such as surgery or biopsy.   "
123682|NCT01667094|"     Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of     secretions, especially in the lungs. By adulthood, the majority of patients with CF will have     a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung     infections. This usually results in worsening respiratory symptoms and often an acute     deterioration in their lung function. They are usually treated with antibiotics that target     the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous     infusions several times a day. This study aims to compare the standard method of giving these     antibiotics with a different strategy of giving these antibiotics to see if this can improve     the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa     in the lungs of these patients. This strategy consists of giving the same antibiotics     continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to     be able to kill the bacteria.   "
123683|NCT01667081|"     This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis)     multicenter study to follow participants who received at least one dose of grazoprevir     (MK-5172) in a previous study to determine whether they remain hepatitis C virus (HCV)-RNA     negative over time, and to determine if they have developed antiviral resistance. The study     will also evaluate long-term adverse events in this population. Participants from MK-5172-052     (NCT02092350) with CKD or cirrhosis will be followed for five years.      As of Amendment 03, the study design is revised such that continued enrollment will only be     for participants who failed prior therapy with a grazoprevir regimen. Participants with CKD     enrolled from MK-5172-052 (NCT02092350) will continue enrollment regardless of prior     treatment-response and remain in this study for five years, while participants enrolled from     all other studies with HCV RNA less than the lower limit of quantitation (LLOQ) will be     discontinued and end their participation after the next scheduled visit. In addition,     participants who receive other HCV treatments concurrent with this follow-up study or     received other HCV treatments prior to this study will be discontinued and their data     excluded from analysis.   "
123684|NCT01667068|"     Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is     rising. Different cohorts are observing an increased risk for cardiovascular diseases in this     aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more     frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and     metabolic disorders also caused by some antiretroviral substances as special non-traditional     risk factors in HIV-infected persons can influence the development of cardiovascular diseases     additionally. Therefore new research focus in special risk profile associated with     HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is     developing.      This present study is an ongoing prospective regional multicenter trial that was conducted to     analyse the incidence, prevalence and clinical course of cardiovacular disorders in     HIV-infected out-patients.      Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary     hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and     heart valve disorders. In addition to previously stated disorders of the heart, the premature     atherosclerosis of coronary arteries, a further even more important disease of the heart in     this patient population, went into the focus of most HIV-researchers and physicians.   "
123685|NCT01667055|"     The true prevalence of drug allergy in patients with a history of penicillin/aminopenicillin     allergy will be determined by using commercially available standard skin test reagents and     the diagnostic agents available in Thailand. We hypothesize that only minority of patients     with such a history are truly allergic.   "
123686|NCT01667042|"     This is a mechanistic research study to evaluate the relationship between cough, reflux, and     aspiration in patients with systemic sclerosis (scleroderma).   "
123687|NCT01667029|"     The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid     arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this     study, the investigators will evaluate whether sulfasalazine improves pain due to painful     peripheral neuropathy.   "
123688|NCT01667016|"     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring     coronary revascularization with Drug Eluting Stents (DES).   "
123689|NCT01667003|"     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring     coronary revascularization with Drug Eluting Stents (DES).   "
123690|NCT01666990|"     HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually     leads to clinically significant immunodeficiency. A chronic generalized immune activation is     now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1     immunity and disease progression during chronic HIV-1 infection. However, it is still unknown     whether reducing immune activation will restore CD4 T cell counts and leading to immune     reconstitution in chronic HIV infection. Tripterygium Wilfordii Hook F (TwHF) has been     demonstrated to decrease immune activation of the host, and can suppress inflammation in     human diseases. Here, the investigators propose a hypothesis that TwHF can reduce immune     over-activation which subsequently leads to the restoration of CD4 T-cell counts and immune     reconstitution in HIV-infected immune non-responders.   "
123691|NCT01666977|"     The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug     measuring progression free survival.   "
123692|NCT01666964|"     We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This     will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can     have life-saving ramifications and enhance quality of life and rehabilitation efforts in our     combat veterans.   "
123693|NCT01666951|"     The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets     administered once-daily compared to Prograf capsules administered twice-daily after kidney     transplantation.   "
123694|NCT01666938|"     The purpose of this study is to investigate the effects of phone counselling support as a     strategy to increase physical activity in people with diabetes.   "
123720|NCT01666600|"     Patients with glioblastoma at first or second progression who have failed standard treatment     that must have included radiochemotherapy with temozolomide and who are a candidate for a     reirradiation can be included into the trial. In the phase I part the minimal tolerated dose     (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II     will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.   "
123695|NCT01666925|"     Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become     more widely available. However, transmission still persists and it appears that additional     control measures are required. The leading malaria vaccine candidate in development is RTS,S     which has efficacy against clinical malaria measured at 30-50% in the field. This partial     protection might be enhanced by combination with other components. The other vaccination     approach that has produced repeatable efficacy in humans is the use of viral vectors to     induce T cell responses. Previous attempts with this vaccine approach have been effective in     challenge studies in Oxford, but ineffective in the field, probably because of reduced     immunogenicity.      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity     by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified     vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with     thrombospondin- related adhesion protein (ME-TRAP).      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and     partial protection in 5 out of 14 volunteers in challenge studies.      The investigators propose a Phase 2b study of 120 healthy adult men in Kenya. The     investigators will assess the efficacy and further evaluate the immunogenicity and safety     profile of the vaccine regimen. The investigators also intend to assess the correlates of     efficacy and natural immunity.   "
123696|NCT01666912|"     This is a prospective study comparing two groups of 48 adolescent women each. The     intervention group will receive a contraceptive implant postpartum, prior to discharge from     the hospital. The control group will receive a contraceptive implant at the usual 6 week     postpartum clinic visit. During prenatal care, participants will be consented and screened     for enrollment. After delivery, these women will be assessed and consented for enrollment     into the study. Women who consent for enrollment will be randomized. Women will be followed     up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each     follow up, women will be assessed for continuation of and satisfaction with this method of     contraception.   "
123697|NCT01666899|"     The purpose of this study is to investigate the effects of radiation therapy following     mastectomy on skin and blood vessels and to use information gathered to determine an ideal     time for breast reconstruction after radiation.   "
123698|NCT01666886|"     In the protocol Predicting therapeutic outcome of mandibular advancement device treatment in     obstructive sleep apnea (PROMAD), 100 patients with obstructive sleep apnea are included and     started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography     with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results     of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD     in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the     most effective protrusion should be a weighted compromise between efficacy and side-effects     of MAD therapy.      In patients with insufficient results on the polysomnography with the MAD at 75% of maximal     protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at     the follow-up visit after the polysomnography with the MAD. After habituation and adaptation     period but within 2 months after the first polysomnography with MAD, a new polysomnography     will be performed to assess the effect of the 90% protruded position.   "
123699|NCT01666873|"     Evaluation of the clinical results after total knee prosthesis, and correlation with the     alignment of the lower limb.      Radiological measurements by means of 3D technology will be performed. The clinical result     will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee     score-questionnaire).   "
123700|NCT01666860|"     During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior     Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of     the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed     and replaced by a bone graft. These patients form the population of this study. The goal of     this study is to evaluate their current medical condition and to determine the clinical     outcome.      The clinical result will be stipulated by means of standardized questionnaires (VAS-score,     Oswestry low Back Pain Questionnaire and SF-36)   "
123701|NCT01666847|"     Milking the umbilical cord from the placental end toward the infant has been shown to benefit     preterm infants when compared to either clamping the umbilical cord immediately or waiting     delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown     to improve heart and lung function, reduces the need for blood transfusion, and reduces the     risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical     cord, however in extremely premature infants is not considered safe, since it also delays the     resuscitation that these infants need immediately after birth. Milking the umbilical cord is     believed have similar benefits to delaying the clamping of the cord, but can be done much     faster (seconds rather than minutes). In this study, the cord will milked three times over     about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for     routine care. Participants of this study will be randomly assigned to one of two study     groups: the first group will have the cord milking intervention and the second group will not     have any intervention other than routine, immediate cord clamping with routine care of mother     and infant. Data will be collected about the mother prior to delivery and data will also be     collected about the baby using computerized health records. The data will look at short term     changes in red blood cell volumes, the need for blood transfusions, and rates of known     complications of prematurity, including longer term developmental complications at 18-24     months.      The hypothesis is that milking the umbilical cord before cutting the cord will lead to a     higher hemoglobin concentration and decrease the need for blood transfusions in extremely     preterm neonates compared to the current standard of immediately clamping the umbilical cord.   "
123702|NCT01666834|"     The characteristics and outcomes of a mixed group of critically ill patients who received     mechanical ventilation are not known in China.      A 1 month Cross-section survey will be performed with the aim of describing the     characteristics and outcomes of conventional mechanical ventilation and treatment of acute     respiratory distress syndrome in intensive care units in China.   "
123703|NCT01666821|"     To investigate pathomorphological and functional variations of choroidal neovascularization     (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical     coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative     AMD.   "
123758|NCT01666106|"     Osteonecrosis of the Jaw (ONJ) Case Registry   "
123704|NCT01666808|"     Prostate cancer is the most common solid tumor, with approximately 200,000 new cases     diagnosed per year. Several different local therapies are available for treatment, including     surgery and radiotherapy Significant advances have been made in the technical aspects of     surgery and of radiotherapy which have improved both the cancer control outcomes as well as     the morbidity of treatment. Despite these significant advances, approximately 30% of patients     treated with definitive local therapy experience recurrent disease. Recurrent disease after     prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA     level is often of limited use in differentiating local recurrence (ie. recurrence in the     prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence).      One PET radiotracer which has shown promise in the staging and restaging of patients with     prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid     (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher     accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with     suspected recurrent prostate carcinoma.      The major goal in this proposed investigation is to use advanced molecular imaging to better     guide post-prostatectomy decision making, in terms of guiding the decision to deliver     radiotherapy, and in terms of the exact areas treated with radiotherapy.      Investigators will perform a study with 162 patients in whom there is a strong suspicion of     prostate cancer that has returned to the body after having a prostatectomy. Half of these     patients will have radiotherapy decision-making and delivery per the usual routine, and half     of these patients will have the radiotherapy decision and volumes guided by the FACBC test.     The major goal of the investigation is to see whether the FACBC improves the selection and     the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.   "
123705|NCT01666795|"     The objective of this human study was to evaluate the association between the specificity of     anti-platelet autoantibodies and response to IVIG treatment.   "
123706|NCT01666782|"     The safety and immunogenicity of high dose influenza vaccine has not been studied in young     patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and     safety of high dose influenza to standard dose influenza vaccine in adult oncology patients     who are younger than 65 years old receiving chemotherapy.   "
123707|NCT01666769|"     Determine proper dosing of micafungin in children supported with extracorporeal membrane     oxygenation (ECMO).   "
123708|NCT01666756|"     This phase I trial studies the side effects and best dose of Chinese herbal formulation     PHY906 when given together with sorafenib tosylate in treating patients with advanced liver     cancer. Biological therapies, such as Chinese herbal formulation PHY906, may interfere with     the growth of tumor cells and slow the growth of tumors. Sorafenib tosylate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib     tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. Giving     Chinese herbal formulation PHY906 together with sorafenib tosylate may work better in     treating advanced liver cancer.   "
123709|NCT01666743|"     The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in     elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic     therapy in the hospital.   "
123710|NCT01666730|"     This phase II trial studies how well metformin hydrochloride, leucovorin calcium,     fluorouracil, and oxaliplatin work in treating patients with metastatic pancreatic cancer.     Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil,     and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Giving metformin hydrochloride together with     combination chemotherapy may kill more tumor cells   "
123711|NCT01666717|"     The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel     Disease(IBD) patients versus healthy controls (HC).   "
123712|NCT01666704|"     The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic     plaque inflammation   "
123713|NCT01666691|"     The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for     certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly     subcutaneous injections for 12 weeks.   "
123714|NCT01666678|"     The purpose of the current trial is to evaluate the bioavailability of a single oral dose of     naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently     marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or     DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.   "
123715|NCT01666665|"     Massive pediatric burns are associated with a persistent and sustained hypermetabolic     response characterized by elevated levels of circulating catecholamine's, cortisol, and     glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound     healing. Insulin and metformin have demonstrated anabolic activity with minimal associated     side effects. However, it is unknown whether the beneficial effects arise from tight     euglycemic control or direct effect of insulin action. We hypothesize that during acute     hospitalization, administration of metformin at a dose titrated to maintain blood glucose     between 80-180 mg/dl will accelerate wound healing and recovery in children with severe     thermal injury and will have beneficial long-term effects on muscle strength, immune     function, and wound healing.   "
123716|NCT01666652|"     The study is designed to afford a first time in humans (FTiH) safety and immunogenicity     assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine     candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or     AS03B (adjuvants used in Glaxo Smith Kline (GSK) Biologicals' hepatitis B candidate vaccine,     malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate     will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally,     the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of     purified virus antigen per each of the four DENV types. The control group will receive a     saline placebo. All experimental vaccinations will be administered according to a 2-dose     schedule, 28 days apart.   "
123717|NCT01666639|"     Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain     has proven its short-term effectiveness. Exercise therapy plays a major role in such a     combination of treatments. There is a considerable need to develop theory-based exercise     interventions which foster a long-term adherence to physical activity. Furthermore, an     integration of behavioral elements such as coping competencies regarding back pain is needed.     It is not yet clear, which specific part of multidisciplinary rehabilitation causes its     effects. The role of exercise therapy has yet to be investigated. Aim of this study is the     implementation of a standardized behavioral exercise therapy into an existing     behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is     that the participation in the behavioral exercise therapy leads to greater short- and     long-term improvements in functional capacity compared to the usual care.   "
123724|NCT01666548|"     The purpose of this study is to investigate the clinical, cognitive outcome and psychosocial     outcome of haemolytic uraemic syndrome in childhood.      The haemolytic uraemic syndrome (HUS) is the leading cause of acute renal failure in     childhood. The more common typical HUS is mostly caused by Shigatoxin-producing     enterohaemorrhagic Escherichia coli (EHEC). The rarer atypical HUS is mainly caused by     different genetic abnormalities in complement regulatory proteins.      About 50 till 60 percent of all patients with HUS develop a severe acute renal failure and     require dialysis. Resulting from new diagnostic and therapeutic approaches the survival rate     increased during the last years. Despite this, there are only few data concerning long-term     prognosis, cognitive and motoric development, as well as psychological coping and     health-related quality of life of affected children and their parents.   "
123725|NCT01666535|"     The investigators will compare the immunogenicity of influenza vaccine in adults and children     with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab     dosing. The primary objective is to compare the proportion of IBD patients on maintenance     infliximab who mount serologic protection to each component of the influenza vaccination     between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients     vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection     will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to     compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase     from pre to post-vaccination titer) to each component of the influenza vaccination between     patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.   "
123726|NCT01666522|"     In the present study the aim was to determine the prevalence of sarcopenia and to evaluate     the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle     mass and strength in community-dwelling older adults with osteopenia /osteoporosis.      One hundred and forty-five individuals aged 65 years and above with documented     osteopenia/osteoporosis were scanned for sarcopenia. The participants were randomly assigned     to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D     (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute     3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day     and the control group was provided with health education using videotaped presentations,     physician talks on topics concerning bone and muscle health. Body composition was measured     DEXA. Vitamin D levels were measured and PA was measured using the Baecke Physical Activity     Questionnaire. Physical performance was assessed using upper limb grip strength, walking     speed and knee extension strength. All data was collected at baseline and at 4 months.   "
123727|NCT01666509|"     Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one     such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™.     Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage 1     is poorly understood and treatment options are limited and therefore this study - within the     target indication - will contribute to the learning about rosacea.   "
123728|NCT01666496|"     The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy     of an interactive video game the investigators are developing at reducing risk behaviors in     at-risk teens.   "
123729|NCT01666483|"     A total of 86 patients underwent total hysterectomy. Three of them refused randomization, 34     were randomly assigned to undergo to laparoendoscopic single-site surgery (LESS) and 34 to     undergo micro-laparoscopy (M-LPS).Laparoscopic hysterectomy can be safely performed by M-LPS     and LESS.   "
123730|NCT01666470|"     Quality of life of patients with a history of drug allergy in Thailand will be studied.   "
123731|NCT01666457|"     The specific aim of this pre-post trial is to compare data regarding oral feeding, length of     stay, and growth outcomes of 100 NICU infants to these same outcomes following the     implementation of a developmentally supportive, infant driven feeding program with the NICU     staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding     program on a second sample of 100 NICU infants at Children's Memorial Hospital.      The specific research questions considered in this study are:        1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically          fragile infants in the NICU at discharge and at 3 months post-term?        2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile          infants in the NICU at discharge and at 3 months post-term?        3. What is the impact of implementing the SOFFI on the length of stay of medically fragile          infants in the NICU?        4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU          staff evaluations and communications related to managing oral feedings with medically          fragile infants?   "
123755|NCT01666145|"     Advanced Image Guidance for this study was used during laparoscopic microwave ablation     surgery to help the surgeon accurately place the ablation needle into the tumor of patients     diagnosed with liver cancer.   "
124033|NCT01662362|"     The study is conducted to meet an FDA post market commitment to collect and report data on     the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are     FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA     Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified     donor specimens will be tested with ABBOTT ESA Chagas assay.   "
123732|NCT01666444|"     The purpose of this study is to compare the overall survival of patients treated with     VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women     with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal     cancer.      VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple     components of the innate immune system and is being developed as a novel therapeutic agent     for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports     the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD     resulted in a significant reduction in tumor growth compared to either agent alone and an     increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and     VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study     and appears to be generally well-tolerated.   "
123836|NCT01665079|"     The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of     a single bolus dose of propofol in obese patients and to extract a time to peak effect     (t-peak) from the estimated model parameters.   "
123733|NCT01666431|"     Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high     frequency of EGF-R expression. EGFR is an important regulator of tumour progression and     proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or     HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition     of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the     investigators hypothesise that EGFR signalling pathway and its interactions play an important     role in the SCC pathogenesis and represent a good therapeutic target from these tumours.      Primary Objectives:      To evaluate the tumour response macroscopically in patients with primary cutaneous SCC     lesions and in concomitant SCC in situ (AK).      Secondary Objectives:        -  To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in          patients with SCC as measured by time to first AE or SAE within the study period.        -  To investigate the molecular tumour response of squamous cell carcinoma lesions in          patients under lapatinib treatment using a set of variables.        -  Trial with medicinal product   "
123734|NCT01666418|"     This is an open, monocentric, pilot study to determine the metabolic activity     (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination     therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of     cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus     paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not     received prior cytotoxic chemotherapy.      Primary Objective:      Evaluation of metabolic activity in vivo      Secondary Objective:      Determination of changes in gene expression profiling Evaluation of the antitumor activity of     the combination in terms of progression free survival (PFS). Changes in S100 and LDH during     therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)        -  Trial with medicinal product   "
123735|NCT01666405|"     The purpose of this study is to determine the effectiveness of percutaneous tibial nerve     stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc.,     Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).   "
123736|NCT01666392|"     The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation     has an impact on inflammation and lean body mass in older adults. The investigators expect     that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass     compared to placebo.   "
123737|NCT01666379|"     The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both     administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol     in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.   "
123738|NCT01666366|"     Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to the     left coronary system in terms of patency and survival benefit. Several BITA configurations     are proposed for left-sided myocardial revascularization, but the ideal BITA assemblage is     still unidentified.      From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our     institution. 481 patients met the inclusion criteria for randomization and 304 (64%) were     randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration     (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months, 3     and 7 years . Patient telephone interviews were conducted every 3 months and a stress test     performed twice yearly under the referring cardiologist's supervision. Angiographic follow-up     was performed 6 months after surgery. The primary and secondary end points were,     respectively, major adverse cerebro-cardiovascular events (MACCE) and the proportion of ITA     grafts that were completely occluded at follow-up angiography.   "
123739|NCT01666353|"     This study aims to develop methods for quantitative imaging of solid tumors in patients who     are receiving immunotherapies that have a delayed mechanism of action.      PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and     is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET     is now used commonly in detecting melanoma in humans as melanomas quite consistently have     high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has     not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been     shown to be highly predictive of outcomes of patients following radioimmunotherapy of     lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy     initiation.      In order to develop PET/CT as a tool to detect early evidence of response in patients with     solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT     imaging prior to therapy, again between days 21 and 28, and finally at 4 months     post-treatment initiation. Each scan will be assessed qualitatively and quantitatively.     Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake     values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic     volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See     section on Outcome Evaluation below.) Investigators will assess whether early changes in     tumor metabolism seen on FDG PET are predictive of progression free and overall survival     outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET     measurements to individual patient responses to immune checkpoint blockade therapy and better     understand and refine this emerging and often effective therapeutic approach.   "
123740|NCT01666340|"     Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The     extent of reduction will be intensity dependent.   "
123741|NCT01666327|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel     disease.   "
123742|NCT01666314|"     This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the     pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly     with prednisone in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer   "
124034|NCT01662349|"     The purpose of this study is to evaluate the safety of treating human skin with atmospheric     plasma and get an initial evaluation of the efficacy of this treatment for acne.   "
123756|NCT01666132|"     Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients     with chronic ischemic heart disease and LVEF < 40%. The primary objective is to determine     whether the administration of the cells improves recovery of the left ventricular function.     Secondary objective is the finding of clinical or paraclinical parameters to predict     potential benefits of the treatment (basing on MRI characteristics such as size,     transmurality of the myocardial infarction and peri-lesional ischemia).      In the first part of the study 10 patients are treated without control group. This phase     serves as feasibility and safety part of the study.   "
123837|NCT01665066|"     The aim of the present study is to compare serum nicotine levels of different e-Cigarette     strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be     also compared.   "
123743|NCT01666301|"     Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing     the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration     interval decreases hemoglobin variability. The benefit of reducing the administration     interval was however lessened by the variability induced by more frequent dosage adjustments.     The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under     different ESAs and administration intervals in a collective of chronic hemodialysis patients.      Methods: The study was designed as an open-label, randomized, four-period cross-over     investigation, including 30 patients under chronic hemodialysis at the regional hospital of     Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies     (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were     compared with each other. The mean square successive difference of hemoglobin, reticulocyte     count and ESAs dose was used to quantify variability. We distinguished a short- and a     long-term variability based respectively on the weekly and monthly successive difference.   "
123744|NCT01666288|"     Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult     to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is     often difficult to pinpoint and may include food, environmental allergens in patients     undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by     demonstration of a positive skin test to the inciting agent, is helpful only if skin testing     is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis     when IgE skin testing is not available and the inciting agent is unknown, is an elevated     serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase     level or if the tryptase level is normal. A simple, non-invasive test for patients with     anaphylaxis is not currently available and would be helpful to diagnose and to guide further     management options.      Patients who develop anaphylaxis to environmental allergens or venoms during routine     outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as     we are able to evaluate these specific reactions in a controlled, clinical environment.     Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4     percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well     established form of therapy for patients with allergic rhinitis, allergic asthma, or a     confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this     group of patients during a reaction and at baseline one week after a reaction, thereby     allowing each patient to serve as his or her own biological control.      Metabolomics is the study of metabolic pathways and the unique biochemical molecules which     result from the regulatory response to physiological stressors, disease processes, drug     therapy, or allergen or venom immunotherapy. By measuring changes in metabolite     concentrations, the range of biochemical effects and therapeutic intervention can be     determined.      The investigator plans to use metabolic profiling of blood samples collected at the time of     anaphylaxis and one week after, to see if a simple, non-invasive test for patients with     anaphylaxis could be developed.   "
123745|NCT01666275|"     Metabolomics is the study of metabolic pathways and the unique biochemical molecules which     result from the regulatory response to physiological stressors, disease processes, or drug     therapy. By measuring changes in metabolite concentrations, the range of biochemical effects     and therapeutic intervention can be determined.      Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease     characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to     aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin     during challenge/desensitization is equivalent to an allergic drug reaction however we are     able to evaluate these specific reactions in a controlled, clinical environment. This     population of patients undergoing aspirin desensitization is ideal for studying metabolomics     as serial blood sampling can be performed in patients before, during a reaction, and after     aspirin desensitization, thereby allowing each patient to serve as his or her own biological     control. The investigator hopes that this study of metabolomics will allow for better methods     of identifying anaphylaxis in the future.   "
123746|NCT01666262|"     The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live     Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral     immune response of the above vaccine after intranasal application by using HAI test, micro     neutralization assays.   "
123747|NCT01666249|"     The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific     antibodies against factor D and neutralizes D antigen present in the Rh-positive fetal red     blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).     This a immunization study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh     and Coombs negative women with risk sensitization.   "
123748|NCT01666236|"     Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary     to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area     after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1)     reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT     ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED)     secondary to Polypoidal Choroidal Vasculopathy (PCV).   "
123749|NCT01666223|"     The purpose of this study is to describe the physiological, pathophysiological and     potentially therapeutic implications of bile-induced glucagon-like peptide-1 (GLP-1)     secretion in human glucose homeostasis.   "
123750|NCT01666210|"     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)     depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation     and pain in subjects who have undergone cataract extraction with intra-ocular lens     implantation.   "
123751|NCT01666197|"     The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet     compared with placebo taken three times a day in subjects with acute ankle sprains under     'in-use' conditions, in particular with regard to pain relief.   "
123752|NCT01666184|"     Study Design:      Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for     pancreatic cancer; (3) willing to sign informed consent.      The pancreatic tumor, tissue specimen and blood sample before or after treatment will be     collected from department of pathology, surgery or diagnostic medicine.   "
123753|NCT01666171|"     RATIONALE: Learning about the effect of metformin hydrochloride in breast density of women     with early-stage breast cancer may help plan treatment.      PURPOSE: This trial studies changes in breast density in patients with early-stage breast     cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32.   "
123754|NCT01666158|"     Consenting patients scheduled for esophageal resection surgery will be randomized to receive     standard nutrition counseling (including nutritional supplements as needed) or standard     nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.      It is hypothesized that, compared with the group receiving nutrition alone, the addition of     physical exercise to nutrition starting before surgery and continuing for 8 weeks after     surgery will have a significantly greater impact on functional walking capacity during the     prehabilitation period and during the postoperative period, and on the incidence of     postoperative pulmonary complications.   "
123759|NCT01666093|"     Background: Lower limb arterial revascularization procedures, either percutaneously or     surgically performed, are an established treatment modality of ischemic foot ulcers,     especially in the setting of a critical limb ischemia. Many other lower limb ulcers are     secondary to a combined disease, which may include a concomitant venous disease (chronic     venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel     disease). In this setting, and especially in the absence of a concomitant severe     macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb     revascularization have so far never been evaluated in a prospective study.      Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular     revascularization approach of the lower limb, in all consecutive patients presenting with a     non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e.     mixed-origin ulcers).      Material and methods: This prospective study will consecutively include all patients     presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer     co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous     disease, infectious disease or inflammatory disorder must be previously evaluated and     adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ±     systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be     obtained in all patients. The arterial screening must included an ankle-brachial index (ABI)     and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot     and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This     arterial work-up must be compatible with the presence of a mild to moderate peripheral artery     disease without any sign or criteria suggesting the presence of a critical limb ischemia.      End-points: The success rate of perform an endovascular revascularization intervention in all     consecutive patients which qualify according to the inclusion criteria (technical     feasibility). Establish the proportion of procedural related complications (safety). Analyze     the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the     improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy).      Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of     enrollment the investigators will perform an interim analysis and will decide at that moment,     according to the observed end-points, if prolonging the study would be of any scientific     value or if the study has to be interrupt earlier because of a significant improvement of all     already treated ulcers.   "
123760|NCT01666080|"     This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell     transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant     or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total     body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve     an acceptable level of donor-derived engraftment following a previous allogeneic HCT.   "
123761|NCT01666067|"     The investigators hypothesize that vytorin will improve insulin resistance compared with     simvastatin   "
123762|NCT01666054|"     The study hypothesis is that reducing patient-ventilator asynchrony will reduce time required     to wean from mechanical ventilation. The purpose of this pilot study is (1) to assess study     feasibility in terms of recruitment, protocol adherence and efficacy of the intervention for     reducing asynchrony, (2) to assess baseline rates of asynchrony and outcomes in the control     arm in order to perform sample size calculations, if needed, for further, larger studies     designed to detect differences in weaning time in specific, predefined populations and (3) to     examine how often ineffective triggering (and therefore reduced ventilator respiratory rate)     at higher levels of pressure support lead to a false conclusion that higher levels of support     are needed to diminish respiratory distress.   "
123763|NCT01666041|"     The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared     with fenofibrate   "
123764|NCT01666028|"     The main objective of this study is to determine the feasibility, efficacy and safety of     automated closed-loop glucose control in the home setting over a short term period. The data     and experienced gained from this study will be utilised in planning future home studies.      This is an open-label, three centre, randomised, crossover design, involving two, 8 day     (first day in the clinical research facility and seven days at home) study periods during     which glucose levels will be controlled either by an automated closed-loop system or by     subjects usual insulin pump therapy in random order. A total of up to 24 adults (aiming for     18 completed subjects) aged 18 years and older with T1D on insulin pump therapy will be     recruited through diabetes clinics and other established methods in participating centres.      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery     system. During the 24 hour in-patient stay subjects will be encouraged to mimic their usual     day and will be allowed to walk inside hospital premises. Subjects will be advised to     discontinue automated closed-loop insulin delivery and follow their usual insulin pump     therapy for periods of strenuous exercise during the 7 day home study phase.      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by     CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the     time spent with glucose levels above and below target, as recorded by CGM, and other     CGM-based metrics, and for the stay at the clinical research facility, time spent in the     target range, above and below the target range as measured by plasma glucose.   "
123777|NCT01665859|"     Umbilical and epigastric hernia repairs are common and performed by numerous surgical     techniques. Considering that the hernia repairs in general are relatively small and simple     procedures there are disproportionate poor results.      The aim of present study is to determine surgical risk factors for readmission after     umbilical and epigastric hernia repair and to report risk factors for later reoperation for     recurrence.   "
123778|NCT01665846|"     The purpose of this study is to describe the radiologic findings on brain MRI after     ferumoxytol administration in HIV-infected patients with cognitive impairment.   "
124119|NCT01661153|"     This prospective observational study will evaluate the use in clinical practice, efficacy and     safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with     HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up     to 2.5 years.   "
123765|NCT01666015|"     Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship     and cure various oncologic diseases. However, this therapy is associated with high mortality     rates and numerous negative side-effects. The recovery of the immune system is a special     concern and plays a key role in the success of this treatment. In healthy populations it is     known that exercise plays an important role in immune system regulation, but little is known     about the role of exercise in the hematological and immunological recovery of children     undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized     Controlled Trial is: study the effect of an exercise program on immune cell recovery in     patients undergoing autologous stem cell transplantation. The Secondary objective is to     determine if an exercise intervention might diminish the deterioration of quality of life,     physical fitness, and the acquisition of a sedentary lifestyle.      Methods      Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to     18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or     control group. The exercise group will participate in a two-phase exercise intervention (in     and outpatient) from hospitalization until 10 weeks after discharge. The exercise program     includes strength, flexibility and aerobic exercise. During the inpatient phase this program     will be performed 5 times/week and will be supervised. The outpatient phase will combine a     supervised session with two home-based exercise sessions with the use of the Wii device. The     control group will follow the standard protocol without any specific exercise program. A     range of outcomes, including quantitative and functional recovery of immune system, cytokine     levels in serum, NK cells and their subset recovery and function, and gene expression of     activating and inhibitory NK cell receptors, body composition, nutrition, quality of life,     fatigue, health-related fitness assessment and physical activity levels will be examined,     providing the most comprehensive assessment to date.      Discussion We expect to find an improvement in the immunological recovery, quality of life,     decreased acquisition of sedentary behavior and less fitness deconditioning.   "
123766|NCT01666002|"     The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond     pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will     compare the success rates of those receiving laser treatments with untreated patients. This     study will provide a clinical basis for determining the relative effectiveness of an     increasingly utilized treatment method.   "
123767|NCT01665989|"     This research project has two primary specific aims in the Partners HealthCare clinical     population and setting:        1. To compare the effects of two interventions, a translation of the Look AHEAD lifestyle          behavioral intervention program with usual care (UC) (brief nutrition counseling and          referral to Nutrition Services, the current standard), on the primary outcome of weight          loss and secondary outcomes of HbA1c, blood pressure, fasting lipid levels, and          prescription medication (doses and costs) for diabetes and its related conditions.           We hypothesize that participants who receive the translation of the Look AHEAD program          will lose significantly more weight and have lower glycemia, blood pressure,          cholesterol, and drug doses and costs for these conditions than participants who receive          UC.        2. To compare the effects of the two interventions on health behaviors, self-efficacy,          diabetes-specific quality-of-life and patient satisfaction with quality of care.      We hypothesize that participants who receive the translation of the Look AHEAD program will     be more satisfied with their care and will experience greater improvements in health     behavior, self-efficacy, and diabetes-specific quality-of-life compared to participants who     receive UC.      Secondary specific aim: To assess the cost-effectiveness of the two interventions and the     potential cost savings in terms of reductions in medication doses. In the current     environment, a cost effective approach to lifestyle change is imperative. The costs and     benefits of the interventions in this project will be carefully analyzed.   "
123768|NCT01665976|"     This single center, randomized, single dose, open-label, four period cross-over study will     evaluate the relative bioavailability of RO4917838 and the effect of food following oral     administration in healthy volunteers. Subjects will receive in randomized order single oral     doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838     hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days     between treatments. Anticipated time on study will be up to 23 weeks.   "
123769|NCT01665963|"     Patients receiving oral anticoagulation or anti-platelet therapy are at high risk of hematoma     after device implantation. This study intends to examine the efficacy of the TopClosure(c)     System in wound healing in these patients.   "
123770|NCT01665950|"     Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an     adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals     with bipolar I disorder in a nonpsychotic major depressive episode.      Hypothesis: Simvastatin will be superior to placebo in improvement of depressive symptoms     assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).   "
123771|NCT01665937|"     STA-9090 works by inhibiting the function of a protein in tumor cells called Hsp90. Hsp90 is     thought to play a role in tumor growth. By interfering with this protein's function, STA-9090     may help kill tumor cells. This drug has been used in other research studies and information     from those studies suggests that this agent may help to slow tumor growth in HCC.      The purpose of this research study is to find the highest dose of STA-9090 that can safely be     given to participants with advanced HCC. The investigators will also get more information     about the safety of STA-9090 and perform tests to learn more about how STA-9090 affects the     body.   "
123772|NCT01665924|"     The purpose of the study is to evaluate the amount of compound present in the blood     (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy     subjects.      During the course of the study, the effect of aging on the pharmacokinetics as well as the     effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics)     will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy     subjects will be characterized.   "
123773|NCT01665911|"     The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind     and will utilize a 5-way cross-over study design with a primary objective to determine if a     higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary     objectives are to determine in a higher concentration of fluoride in milk will provide a     greater caries preventive effect and if the caries preventive effect of fluoridated milk     follows a dose-response pattern.   "
123774|NCT01665898|"     Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon     polyps.   "
123775|NCT01665885|"     HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy,     tolerability, practicability and safety of endovascular versus surface cooling in awake     stroke patients.   "
123776|NCT01665872|"     Phase II of the MOMS Partnership aims to:        1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;        2. provide on-site group intervention services (randomized by housing community) to improve          signs/symptoms of depression/stress/trauma among mothers living onsite.   "
123779|NCT01665833|"     We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an     independent predictor of recurrent or persistent angina following coronary revascularization.     The SYNTAX score is a score that suggests the severity of coronary artery disease detected by     coronary angiography. Coronary revascularization is a procedure that occurs in two ways, a     percutaneous coronary intervention (PCI) and a coronary artery bypass graft (CABG) and is     done when there is narrowing and blockage or hardening of the arteries (atherosclerosis)     surrounding the heart. Narrowing and blockages reduce blood flow to parts of the heart     causing chest pain (known as angina) and sometimes myocardial infarction.   "
123780|NCT01665820|"     Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more     effective in identifying referrable murmurs than using a traditional stethoscope.   "
123781|NCT01665807|"     The investigators hypothesize that people working in an acute care hospital setting will be     able to successfully self-administer the intradermal vaccine (Intanza) in less time than     nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The     investigators also hypothesize that people administering the intradermal vaccine for the     second time will take less time to successfully administer than people administering it for     the first time.   "
123782|NCT01665794|"     This phase I/II trial studies the safety and the best dose of carfilzomib and to see how well     it works when given together with pomalidomide and dexamethasone in treating patients with     relapsed or refractory multiple myeloma. Carfilzomib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Pomalidomide may stimulate the immune     system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such     as dexamethasone, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving carfilzomib together with     pomalidomide and dexamethasone may kill more cancer cells   "
123783|NCT01665781|"     Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore     subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence     of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m     plus the presence of one or more of the following: gastrointestinal symptoms (anorexia,     nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass     is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO)     secretion begins hours after ascent and stimulates bone marrow production of red blood cells,     but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that     EPO therapy weeks before altitude exposure decrease high altitude illness.      In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM)     reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal     oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the     basis of this report, USARIEM did not recommend use of recombinant EPO for altitude     acclimatization.      However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO     therapy have been shown to decrease fatigue and increase work capacity and exercise     tolerance. In addition, improvement in CNS function and cognitive ability has been noted with     EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold;     decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are     symptoms associated with high altitude illness.      The investigators also reported improved muscle energy metabolism with EPO in dialysis     patients, but not with RBC transfusion.      In this study, the investigators will conduct a randomised controlled trial to assess the     effect of EPO administration on AMS at an altitude of 4,130 m.   "
123784|NCT01665768|"     This research is being done to determine if combining an investigational drug called     Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose     chemotherapy.   "
123785|NCT01665755|"     In this study, we are comparing the difference in outcomes between patients who were given     shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before     CPR is started. The study population will be all cardiac arrest patients attended by the     staff of the Emergency Department who fulfil the eligibility criteria. Patients will be     managed according to currently approved cardiac arrest protocols. Patients confirmed in     cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest     compressions are delivered by an automated device) is prepared. Mechanical CPR should be     started as soon as possible (<1 minute). If patients are eligible to be shocked, they will     receive shocks either during upstroke of CPR or before CPR is started.      Thus the purpose of this study is to answer the question whether are there improvement in     survival between when shocks are given during upstroke and before CPR is started.   "
123786|NCT01665742|"     The number of overweight and obese children has increased in Ireland at a greater rate than     worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase     in the number of unhealthy inflammatory hormones and fats circulating in the blood which     increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary     patterns have changed whereby key nutrients that are found in fruit, vegetables and fish,     which are known to have beneficial effects and reduce risk of obesity and diabetes in later     life, may need to be replaced. This project will determine whether a key anti-inflammatory     nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged     13-18 years old. Detailed cellular analysis will determine the cellular and molecular     mechanisms to provide a thorough explanation of the health effects of this intervention.   "
123787|NCT01665729|"     Negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the     early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent     episodes, and 10% patient died. Therefore, diagnosis and treatment of minor ischaemic stroke     according to the etiology and pathogenesis is important.      The 2007 Korean modified TOAST type got some progress, but there exists two major     disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction etiology;     lack of typing according to the pathogenesis of large atherosclerotic infarction and taking     measures of treatment according to the new types. Recently, domestic professor Gaoshan     proposes new approach to diagnose and treat minor ischaemic stroke according to the etiology     and pathogenesis of CISS typing, but the pathogenesis of hypoperfusion infarction with severe     stenosis of large artery is unclear. Is it low perfusion? Or artery-artery embolization? Or     both? How to distinguish the pathogenesis of branch artery disease: by atherosclerosis? Or     hyalinosis? Or both? How to check the validity of clinical types? This study take different     interventions according to different types and observation of the long term clinical results     of intervention( mortality, recurrence rate, disability rate and rate of cerebral hemorrhage     and subarachnoid hemorrhage), in order to clarify the new types can indeed solve the current     problem of minor ischaemic stroke with high mortality, recurrence rate, disability rate and     rate of cerebral hemorrhage and subarachnoid hemorrhage.   "
123788|NCT01665716|"     In healthy women, early menopause is an event that is associated with the exacerbation of     several risk factors of cardiovascular and skeletal disease. The occurrence of an early     menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A small     number of studies has demonstrated that DM-1 patients experience cycle irregularity and     menopause at a younger age compared to controls. In addition, initial studies have suggested     that also in regular cycling DM-1 women a decreased ovarian reserve status for age is     present. The explanation for this early decay in ovarian reserve in DM-1 patients remains     unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated     ovarian ageing in DM-1 patients.      Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of     the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian     ageing, with focus on vascular factors, may shed new light on our understanding of the     ovarian ageing process per se.   "
123789|NCT01665703|"     This pilot study is designed to evaluate imaging parameters indicative of underlying tumor     biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)     who are planning to undergo nephrectomy will be identified, and recruited to undergo a     contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography     (MR-FDG-PET) scan.   "
123790|NCT01665690|"     The Washington State Community Expedited Partner Therapy Trial is a stepped-wedge community     level randomized trial designed to test the hypothesis that a public health program designed     to increase the use of expedited partner therapy can decrease the prevalence of chlamydial     infection in young women and the incidence of gonorrhea in Washington state. The study     intervention will be modeled after and intervention previously evaluated in King County WA     (Golden MR, Sex Transm Dis 2007;598-603). The intervention has two components: 1) promotion     of patient delivered partner therapy (PDPT) use by medical providers in accordance with     Washington state guidelines; and 2) targeted provision of partner services. PDPT use will be     promoted through education and by making medication packs for PDPT available statewide.     Medical providers will refer selected persons with gonorrhea or chlamydial infection for     partner services based on defined criteria associated with failure to ensure partners'     treatment. The intervention will be instituted in four waves separated by 6-9 months. Each     wave will include approximately 6 local health jurisdictions. The order in which health     jurisdictions initiate the intervention will be randomly assigned. The study's primary     endpoint will be the prevalence of chlamydial infection in women age 15-25 tested through     clinics participating in the state's Infertility Prevention Project (IPP) and the incidence     of gonorrhea among women as determined through public health reporting.   "
123791|NCT01665677|"     Hematopoietic stem cell transplantation is a procedure in which a person receives blood     forming stem cells from a person called a donor. The stem cells can be obtained from the     hollow part of the hip bone or from blood.      A serious problem with this treatment is graft-versus-host disease (GVHD). This happens when     stem cells from the donor attack normal cells of the recipient. Currently, there is no     universal standard of care in the United States to prevent GVHD.      This study is being done to see if a medicine that is used to lower cholesterol can also help     in reducing GVHD.      Patients will receive atorvastatin daily by mouth starting 14 days before stem cell     transplant. They will continue to take atorvastatin until 180 days after transplant. This     medicine may be stopped earlier if there is a bad side effect or a severe GVHD. Patients will     also receive standard treatment to prevent GVHD. Patients will undergo many tests that are     standard for their treatment at West Virginia University (WVU), including blood tests to     check blood counts, kidney function and HIV status; blood test to check for pregnancy; Multi     Gated Acquisition Scan (MUGA scan)or echocardiogram to test heart function; lung function     testing; and bone marrow aspirate or biopsy. Patients will also have the option to provide     blood samples for optional research related to the study.   "
123792|NCT01665664|"     Underfeeding in the critically ill patient is a common observable fact throughout intensive     care units. Patients who develop caloric deficit during their stay in the ICU have been shown     in previous reports to be associated with increased complications such as increased rate of     infections, and nosocomial blood stream infections. Yet, other studies have shown that     patients with moderate caloric deficit may be associated with better outcome than patients     who receive higher levels of caloric intake.   "
123793|NCT01665651|"     Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or     bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected     with decrease of renal function. In traditional Chinese medicine, kidney function is     considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment     will help improve bone development and metabolism.   "
123794|NCT01665638|"     The purpose of this study is to assess whether treatment with a single oral 300 mg dose of     canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a     protein released from the pancreas during insulin secretion) in healthy adult volunteers.   "
123795|NCT01665625|"     Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic     cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic     cancer for over two decades and combinations of gemcitabine with different chemotherapeutic     drugs have been investigated to improve the outcomes of pancreatic cancer. However, no     substantial improvement in patient survival has been achieved. Locoregional chemotherapy via     intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug     concentrations and reducing systemic toxicities. In this study, the investigators hypothesis     that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy.     The investigators will analyze and evaluate the effect and safety of an implanted     percutaneous left subclavian artery port-catheter drug delivery system for regional     chemotherapy of inoperable pancreatic carcinoma.   "
123796|NCT01665612|"     The purpose of the clinical investigation is to assess the clinical and subjective     performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two     silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).   "
123797|NCT01665599|"     This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone     concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy     of testosterone gel (2%) delivered using an applicator.   "
123806|NCT01665482|"     Rationale: It is well established that increased intake of saturated fatty acids (SFA) is     associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by     dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to     clarify the association between dietary fatty acids and metabolic risk markers beyond lipid     profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy     replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited     evidence is available on the effects of dietary fatty acids on insulin sensitivity and     secretion. The current study is designed to investigate the effects of SFA versus MUFA versus     CARB on insulinemic response and lipid metabolism in healthy individuals with central     obesity.      Study design: A randomized, crossover, single blind design study was carried out. The     subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day     during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein     content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy     intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based     on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total     energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000     kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the     exchange from oleic acid (C18:1).      Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence     insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid     metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be     comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin     sensitivity, endothelial and vascular function and inflammation   "
124037|NCT01662310|"     The purpose of this study is to evaluate the efficacy, tolerability and safety of     paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in     the prevention of relapse in schizophrenia participants.   "
123798|NCT01665586|"     Recently many studies reported that intraoperative dexmedetomidine administration undergoing     spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory     depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose of     dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not     got general consensus.      The investigators hypothesized that the dose requirements would be lower than in elderly     patients than young patients. Furthermore, intrathecal small dose opioids enhance the     analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of     dexmedetomidine.      The purpose of this study was to determine the dose of dexmedetomidine to provide     satisfactory sedation undergoing spinal anesthesia with or without additive small dose     intrathecal opioids.      Elderly patients(65~85 years old) undergoing TURP or TURB were enrolled in this     single-blinded study. Forty patients were randomly assigned to receive intrathecal hyperbaric     bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. After the     induction (bilateral T10 sensory level to pinprick within 5 mins of intrathecal drug     administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5,     0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4 within 20 minutes     of dexmedetomidine infusion. The dose of dexmedetomidine was selected for each patient     according to an up and down method. Intraoperative arterial pressure, heart rate, and     bispectral index was compared. Postoperative pain score, the time for the regression of     sensory and motor was recorded for further analysis.   "
123799|NCT01665573|"     The purpose of this double blind, randomized, controlled, proof-of-concept study is to test     the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On     three days over not more than two weeks, subjects will be trained to associate cues with two     different stimuli, then this association will be extinguished. Cannabinoid receptor     stimulation will be accomplished indirectly by harnessing the brain's capacity to     endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents     degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845.     Some details of this study have not been disclosed to preserve the study design.   "
123800|NCT01665560|"     The overarching goal of this project is to understand how nicotine addiction interacts with     feeding behaviors and brain representation of food reward. The current proposal is part of a     larger effort to begin a program of research to elucidate similarities and differences in     perception of, and behavioral and neural response to, food and cigarette aromas as a function     of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain     weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute,     chronic). A general hypothesis is that there are overlapping neural mechanisms governing food     reward and cigarette reward in smokers and that this overlap includes incentive salience     encoding.   "
123801|NCT01665547|"     Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation     induction in women with clomiphene resistant PCOS   "
123802|NCT01665534|"     Salt is a main environmental risk factor involved in atherosclerotic complications and in the     high risk of a variety of cardiovascular (CV) diseases including hypertension, left     ventricular hypertrophy (LVH), chronic kidney disease (CKD) and heart failure. The link     between sodium and cardiovascular disease is complex and involves blood pressure (BP)     dependent and independent mechanisms. Among the latter, inflammation is suspected to be a     major effector of arterial damage brought about by the salt excess in animal models. In     humans, C-Reactive Protein (CRP) associated directly with dietary salt intake in a     population-based survey but such a link was not confirmed in other studies. This apparent     discrepancy may depend on the observational (i.e., open to confounding) nature of these     studies. Inflammatory cytokines are essential for the short term systemic response to     environmental stressors. For example it is well established that TNF-α, a cytokine that     modulates renin gene expression by signalling via TNF-receptor 2, exerts a protective effect     for the myocardium in a stressful condition like experimental cardiac ischemia while low     levels of adiponectin have a detrimental effect in the same setting. Thus, the     inflammation-sodium relationship may be non-linear and severe salt restriction may actually     trigger inflammation, a hypothesis suggested by the observation that biomarkers of     inflammation rose in response to salt depletion in a sequential study in essential     hypertensives. However, the lack of randomization in this study leaves open the question     whether the observed pro-inflammatory effect was due to change in salt intake or to other,     unmeasured time-dependent effect(s). With this background in mind the investigators setup a     randomized, single masked, cross-over study to assess the effect of a short term very low     salt diet on biomarkers of innate immunity in patients with uncomplicated essential     hypertension.   "
123803|NCT01665521|"     Our research will examine a chest pain care strategy, called the HEART pathway, which is     designed to correctly identify Emergency Department patients at high-risk for cardiovascular     events, likely to benefit from further testing, and patients at very-low-risk for     cardiovascular events, who may be safely discharged home. By using an individual's risk     assessment to determining testing, we hope to improve the quality and efficiency of the care     delivered to Emergency Department patients with chest pain. Our study will determine if the     HEART pathway, which combines a clinical decision rule, the HEART score, and two serial     troponin measurements, will reduce stress testing and cardiovascular imaging, decrease     hospital length of stay, and reduce cost compared to usual care, while maintaining safety.   "
123804|NCT01665508|"     Women have less significant blockages of coronary arteries, however have greater symptoms and     worse outcomes compared to their age-matched male counterparts. This paradox has led to the     recognition and importance of the microvasculature ( small vessels) as a contributor to     symptoms and outcomes. Nebivolol has unique antioxidant properties and dilates blood vessels     and it is therefore proposed that treatment with nebivolol will reduce angina (chest     symptoms) in women with microvascular disease as well as improve exercise capacity, reduce     resource utilization and improve other measures of artery function.   "
123805|NCT01665495|"     The DROP study is a prospective, multi center, randomized, open-label trial to test the     efficacy and safety of extended catheter pericardial drainage in patients with non-malignant     pericardial effusions.   "
123815|NCT01665352|"     The purpose of this study is to compare the safety and effect of TTP054 versus placebo on     glucose control in patients with type 2 diabetes.   "
123816|NCT01665339|"     Investigators presumed that preload consumers will have more weight reduction and lower risk     of cardiovascular disease   "
124161|NCT01660607|"     For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with     a T cell depleted graft, the infusion of naturally occurring regulatory T cells with     conventional T cells (T cell addback) in pre-defined doses and ratios will reduce the     incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and     improving immune reconstitution.   "
123807|NCT01665469|"     Consumption of a high-fat meal results in a postprandial (fed-state) response characterized     by hypertriglyceridemia. Postprandial hypertriglyceridemia increases the oxidation of     low-density lipoproteins (LDL) and increases blood concentrations of several biomarkers of     inﬂammation. This postprandial lipemia-induced oxidative stress mediated response to a     high-fat meal has been suggested as a major contributor to the pathogenesis of     atherosclerosis along with other chronic disease states of diabetes and obesity. Consumption     of foods rich in antioxidant compounds provides a defence source to compliment endogenous     defence systems to protect against oxidative damage during pro-oxidant conditions.      The hypothesis of the study is that tomato extracted lycopene will be able to decrease     postprandial oxidation and inﬂammation in healthy weight men and women when compared to     Placebo.   "
123808|NCT01665456|"     Kenya is one of the countries in sub-Saharan Africa that still experience high maternal     mortality. For instance, in 2008/09 maternal mortality ratio was estimated to be 488/100,000     live births. Direct obstetric complications such as puerperal sepsis, postpartum hemorrhage,     pre-eclampsia and eclampsia, obstructed labor and indirect causes including HIV, malaria and     anemia in pregnancy are responsible for the majority of these cases. Just under 44% of births     in Kenya are delivered under the supervision of a skilled birth attendant.      The overall objective of this study is to determine the effect of provider type in the     occurrence and management of serious childbirth related complications among postpartum women     at the community level in Bungoma and Lugari Districts of Western Province, Kenya.      The proposed study will employ a case control study design in which women with obstetric     complication(s)will be cases and women without obstetric complications will be controls.     Controls will be sampled concurrently with the cases. Each time a new case is diagnosed, a     control is selected from the population at risk in the neighborhood at that point in time.      The study population will consist of women aged 15-49 years with a delivery in the past 12     months. A woman who reports having experienced a birth-related complication will be recruited     as a case while woman who reports having experienced no complication during child-birth will     be recruited as a control.   "
123809|NCT01665430|"     This multicenter, open-label, single arm long term extension of study WA19926 will evaluate     the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with early, moderate     to severe rheumatoid arthritis who have completed the WA19926 core study. Eligible patients     will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.   "
123810|NCT01665417|"     This study is designed to compare the efficacy and safety of first-line icotinib treatment     and first-line chemotherapy followed by maintenance treatment with icotinib.   "
123811|NCT01665404|"     This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on     the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a     single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a     cross-over design. The anticipated time on study treatment is 40 days.   "
123812|NCT01665391|"     The primary objectives of this trial are as follows:        -  to compare the achievement of a partial remission (PR) or complete remission (CR) in          urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab          versus placebo        -  to compare the safety profile of patients treated with fresolimumab versus placebo      The secondary objectives are as follows:        -  To compare the reduction in proteinuria in patients treated with fresolimumab versus          placebo        -  To evaluate fresolimumab dose-dependent reduction in proteinuria        -  To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in          patients treated with fresolimumab versus placebo        -  To evaluate the multiple-dose pharmacokinetics of fresolimumab   "
123813|NCT01665378|"     Low birth weight and anemia remain intractable problems in many developing countries despite     considerable efforts to address them. Intervening with just prenatal iron-folate (IFA)     supplements may not be the best approach given the substantial demands for iron by maternal     and fetal tissues. Therefore, there is an urgent need to evaluate the additional contribution     of prepregnancy interventions. We propose a double blind randomized controlled trial in rural     Vietnam to evaluate the efficacy of weekly pre- pregnancy IFA or Multiple Micronutrient (MM)     supplements on birth outcomes and maternal and infant iron status compared to providing only     prenatal IFA supplements. This project is a collaborative effort between Emory University,     USA and Thainguyen University of Medicine and Pharmacy, Vietnam. Eligible and willing women     of reproductive age (WRA) will be assigned randomly to one of the following 3 groups of     pre-pregnancy weekly supplementation: 1) FA (control) 2) IFA and 3) MM. All women will     receive daily IFA when pregnant. We will recruit ~ 5000 WRA to obtain a sample of at least     1650 mother-infant pairs, which, at 90% power, will allow us to detect differences of ~ 60 g     in birth weight between any two groups. Data on obstetric history, socio-demographic status,     iron status, anthropometry and dietary intakes will be obtained at baseline. Key outcome     measures will be 1) offspring's size and gestational age at birth 2) offspring's iron status     at birth and 3 months of age and 3) maternal iron status at the beginning of pregnancy, 1 and     3 months post-partum. Intention to treat approach will be used to compare the various     intervention groups. This study is timely and responds to the WHO Global Expert Consultation     (2007) which identified the need to evaluate the long term benefits of weekly IFA and MM     supplementation in WRA. The findings will provide the necessary evidence to policy makers to     recommend weekly MM or IFA supplements to WRA to improve birth outcomes. The central     hypothesis is that pre-pregnancy weekly IFA or MM supplementation followed by prenatal IFA     and MM supplementation respectively, will improve birth outcomes as well as maternal and     infant iron status compared to current practice of providing only prenatal IFA supplements.     This hypothesis will be tested by conducting a randomized double-blinded placebo-controlled     trial in Vietnam.   "
123814|NCT01665365|"     The aim of this prospective follow-up study is to investigate 5-year clinical outcome in     patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning     before primary percutaneous coronary intervention.   "
123817|NCT01665326|"     This is a longitudinal natural history study of Infantile Pompe disease. The investigators     will regularly collect and review medical information for up to 10 years regarding the     diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa     (Myozyme) and response to immunosuppressive therapy in cases at risk for developing or those     who have developed high and sustained antibodies to ERT. A subset of de-identified     information about the natural history of Pompe disease and the response to treatment will be     incorporated into the Lysosomal Disease Network (LDN) disease registry. The LDN is a     nonprofit organization of scientists located around the world whose research focuses on     Lysosomal disease.      The specific aims of this study are:        1. To determine and correlate Cross-Reactive Immunological Material (CRIM) status with the          GAA gene mutations found on these patients        2. To validate an approach for determining CRIM status from whole blood sample, with the          gold standard determination of CRIM status by skin fibroblasts and mutation analysis        3. To explore the clinical treatment response and natural history of CRIM-positive and          CRIM-negative Pompe disease patients with and without immune modulation        4. To investigate the role of immune response to treatment   "
123819|NCT01665300|"     Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type     2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment     has been mandated to detect myocardial dysfunction because of the risk of heart failure with     this treatment. Myocardial deformation imaging is a sensitive means of detecting LV     dysfunction, but this technique has not been evaluated in patients treated with trastuzumab.     The aim of this study was to investigate whether changes in tissue deformation, assessed by     myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than     conventional echocardiographic measures in patients treated with trastuzumab.   "
123820|NCT01665287|"     Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The     commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to     test for their relative sensitivity for low oxygen levels just after birth on term infants     born by elective cesarean section. Reproducibility will be examined by replacements of the     sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be     used.   "
123821|NCT01665274|"     The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative     chemotherapy is superior or not to operation directly for locally advanced gastric cancer in     terms of 3 year disease-free survival (DFS) rate.   "
123822|NCT01665261|"     The purpose of this study is to test the accuracy of 7 indicators in screening congenital     heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these     indicators could be applied in the nationwide newborn CHD screening. The investigator's     hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable     accuracy.   "
123823|NCT01665248|"     The purpose of this study is to evaluate the correlations between active calcification and     vulnerable plaque.   "
123824|NCT01665235|"     Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with     intracranial artery stenosis   "
123825|NCT01665222|"     The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide     from 2 tablet products and determine if the 2 products were bioequivalent to each other.   "
123826|NCT01665209|"     The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide     from 2 tablet products and determine if the 2 products were bioequivalent to each other.   "
123827|NCT01665196|"     This is an open-label study to investigate the diagnostic performance of 18F-FDG PET/CT     (positron emission tomography/computed tomography) in evaluation of patients with     IgG4-related disease. A single dose of 18F-FDG will be intravenously injected into patients     with IgG4-related disease before and after treatment.   "
123828|NCT01665183|"     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from     microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has     been used to treat patients that have cancers that require arginine. In this study, ADI will     be combined with the well known chemotherapy cisplatin, and the safety and potential efficacy     of this combination will be explored in patients with cancers that require arginine.   "
123829|NCT01665170|"     A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora     incarnata L. in an acute stressful situation   "
123830|NCT01665157|"     The purpose of this study is to evaluate the efficacy and the acceptability of low-residue     diet package (Enimaclin®) as diet control before colonoscopy.   "
123831|NCT01665144|"     Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment     duration in patients with secondary progressive multiple sclerosis (Core Part) followed by     extended treatment with open-label BAF312 to obtain data on long-term safety, tolerabiilty     and efficacy (Extension Part).   "
123832|NCT01665131|"     Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk     of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They     have conventionally consisted of a generator sitting under the skin of the chest and leads     which pass from veins in the collar bone region to the heart. Problems with these devices can     necessitate extraction, with the commonest reason being infection. If extraction is required     for infection then re-implantation is usually deferred for approximately one week whilst     antibiotics are given so that the risk of infection of the new device can be minimised. This     has considerable implications for healthcare resources. A new ICD has been developed that is     entirely subcutaneous with no intravenous element. It is already in clinical use and is     positioned remote from conventional ICD sites. With no intravenous element there is very     little risk of infection in the blood affecting the new device. It is therefore likely to be     possible to re-implant these devices immediately after extracting a conventional system. The     aim of this research is to assess the outcome in patients re-implanted with this device     immediately after conventional ICD system extraction. This data will be compared compared to     those who have conventional systems re-implanted after the necessary delay.   "
123834|NCT01665105|"     The purpose of this present study was to investigate the effect of electroacupuncture at both     Zusanli and at both Yanglingquan acupoints on autonomic nerve modulating cardiovascular     activity, and skin blood flow and skin temperature. The investigators use pulse rate     variability to investigate autonomic nerve modulates cardiovascular function, and using     distant skin blood flow and skin temperature recordings to investigate the relationship     between the same names meridian of hand and foot.   "
123835|NCT01665092|"     Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate     oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling     and cardiac mechanical efficiency. The overall goal of this proposal is to investigate     L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators     will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor     dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an     associated decrease in 28-day mortality suggesting the need for further phase III study. To     accomplish this the investigators will conduct a phase II, double blinded, placebo     controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent     septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or     high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early     resuscitative care.   "
123838|NCT01665053|"     The purpose of this study is to assess the safety and effectiveness of the SYNERGY     Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with     atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries     ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).   "
123839|NCT01665040|"     The primary objective of this study is to investigate patient satisfaction with treatment     using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.   "
123840|NCT01665027|"     The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to     2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction     in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of     delivery by vacuum in C/S with normal caesarean section.   "
123841|NCT01665014|"     The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole     preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT)     followed by high-dose melphalan used prior to second autoHSCT is safe and effective in     patients with multiple myeloma (MM).   "
123842|NCT01665001|"     The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if     individual therapeutic approach taking into account biological and phenotypic differences as     well as response at the level of minimal residual disease is associated with improved outcome     of adults with precursor lymphoid neoplasms   "
123843|NCT01664988|"     Gestational hypertension is the main cause of maternal and fetal mortality, however, it has     no definite effective treatment. nowadays, the stress management approaches are use for     essential hypertension. So, this study aimed is study the effect of progressive muscular     relaxation and breathing control technique on blood pressure during pregnancy.      this 3-groups clinical trial has been done in Mashhad Health Centers and Governmental     hospitals. 60 pregnant women with systolic blood pressure less than 135 mm Hg or diastolic     blood pressure more than 85 mm Hg who met inclusion criteria were assigned into three groups     of progressive muscular relaxation, breathing control and control. In tow experiment groups,     exercises were controlled by one day personally and the rest by CD, BP before and after     interventions was controlled for 4 weeks. In control group blood pressure was measured before     and after 15 minutes with no intervention.   "
123844|NCT01664975|"     The purpose of this study is to evaluate the efficacy and safety of GDPT regiment     (gemcitabine，cisplatin,Prednisone ,Thalidomide      ) for patients with Peripheral T-cell lymphoma.   "
123845|NCT01664962|"     The purpose of this study is to investigate the possibility of an association between     Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic     markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase     (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).   "
123846|NCT01664949|"     This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop     formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops     (OPTIVE™) in subjects with dry eye disease.   "
123847|NCT01664936|"     The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence     or effect that is used with a standard clinical PET/CT and/or investigation scans can be done     in order to capture tumor sizes. The investigators believe endoscopies and surgical     procedures could benefit from this type of imaging in the future. The Cerenkov imaging could     be used as a guide for surgical resections.      The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or     other investigational tracers to image tumors and its sizes in the head, neck, breast,     axillary and pelvic regions with a highly sensitive camera. The investigators will be trying     to see if we can get another picture of the tumor using the Cerenkov light as part of the     standard clinical scan or therapy.   "
123848|NCT01664923|"     The purpose of this study is to determine the safety and efficacy of enzalutamide vs     bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have     disease progression despite primary androgen deprivation therapy.   "
123849|NCT01664910|"     The goal of this clinical research study is to learn which dose level of inotuzumab     ozogamicin (CMC-544) work best when given with fludarabine and bendamustine, with or without     rituximab, before a stem cell transplant.The safety of this treatment will also be studied.      Fludarabine, bendamustine, and rituximab are commonly given before stem cell transplants.     These drugs are designed to kill cancerous cells and suppress your immune system in order to     lower the risk of stem cell transplant rejection.      Inotuzumab ozogamicin is designed to kill cancerous cells and reduce the risk of the cancer     coming back.   "
123852|NCT01664871|"     There is growing worldwide interest in the use of diammine silver fluoride (DSF) as a topical     agent to treat dentin hypersensitivity and dental caries. It has been available in various     formulations for many years, but its safety profile has never been fully characterized.      This preliminary study determined the applied doses (3 teeth treated), maximum serum     concentrations, and time to maximum serum concentration for fluoride and silver in 6 adults     over 4 h. Fluoride was determined using the indirect diffusion method with a fluoride     selective electrode, and silver was determined using inductively coupled plasma-mass     spectrometry. The mean amount of DSF solution applied to the 3 teeth was 7.57 mg (6.04 µL).   "
123853|NCT01664858|"     CE-MARC 2 is a randomised controlled trial to determine diagnosis and patient management in     patients presenting to outpatient clinics with suspected stable angina. Cardiac Magnetic     Resonance Imaging (at 3Tesla) will be evaluated prospectively against current best clinical     practice (defined by international guidelines). The study hypothesis is that 3Tesla     CMR-guided management of patients with suspected stable angina is superior to current     clinical practice based on 1) the principles of the National Institutes for Clinical     Excellence (NICE) CG95 guidelines (2010); 2) SPECT AHA appropriateness criteria, in terms of     avoiding study-defined unnecessary invasive coronary angiography.   "
123854|NCT01664845|"     The aim of the study is to investigate the treatment response of metformin, Peg-IFN and     ribavirin combination therapy for chronic hepatitis C virus (HCV).   "
124022|NCT01661387|"     As a post-approval requirement of the European Medicines Agency, this European patient post     authorization safety study is an observational study being conducted to monitor the safety of     long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine     clinical practice in patients with chronic adrenal insufficiency (primary or secondary).   "
123855|NCT01664832|"     The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as     compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants     immediately after extubation when recovering from Respiratory distress syndrome (RDS).      Another objective is to examine the effects for synchronized non-invasive mechanical     ventilation on gas exchange and cerebral oxygen saturation.   "
123856|NCT01664819|"     Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor     Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from     1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural     villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15     mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no     significant difference in cataract formation between the antioxidant group and placebo. In     this follow-up study, we will return to study villages to determine whether rates of cataract     surgery are different in the 2 groups.      1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts     Study: effects of antioxidant supplements on cataract progression in South India. The British     journal of ophthalmology 2006;90:847-51.   "
123857|NCT01664806|"     Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy     operation. The appearance of burns are common following laparoscopic cholecystectomy;     particularly at the port site of the active electrode. Willson et al found that 9 out of 19     skin biopsies from the skin adjacent to the port site of the monopolar instrument's active     electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997)     11:653] Authors have speculated that using different generator modes may lead to less     capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support     these speculations.      The investigators hypothesize that capacitive coupling electrosurgical injuries from     monopolar instruments are occurring during laparoscopic cholecystectomy operations. The     investigators hypothesize that use of blend modes will reduce the incidence of capacitive     coupling thermal injuries during laparoscopic operations in comparison to coag modes.   "
123858|NCT01664793|"     The purpose of this study is to increase childhood influenza vaccination rates using the FDA     licensed influenza vaccines according to national guidelines in a randomized cluster trial in     which primary care offices are randomized to intervention or control with the control group     receiving the intervention in the second year.   "
123859|NCT01664780|"     Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI)     imaging to assess liver fibrosis in patients after orthotopic liver transplantation.      Material and methods: We prospectively assess the performance of ARFI imaging in planned 100     patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left     and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the     results with clinical data and B-mode criteria.      ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic     fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in     patients after orthotopic liver transplantation. Therefore we want to establish standard     values in this population.   "
123860|NCT01664767|"     The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the     airways characterized by fixed airflow obstruction, with important systemic co-morbidities.     The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette     smoking is the major cause of this disease. COPD is an important cause of morbidity and     mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in     the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide     anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative     processes at the cellular level. These molecules can alter the extracellular matrix     remodeling, cell respiration, cell proliferation, cellular repair and the immune response in     the lung. All these events are key elements in the pathogenesis of COPD.      Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled     corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal     inhalation treatments are a therapeutic strategy used since many years in an empirical way in     patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with     COPD are very limited.      The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water     inhalation on oxidant stress in the airways of stable COPD patients.   "
123861|NCT01664754|"     This phase I trial studies the side effects and best dose of exemestane in combination with     pemetrexed disodium and carboplatin in treating post-menopausal women with stage IV non-small     cell lung cancer. Exemestane may stop the growth of tumor calls by blocking some of the     enzymes need for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Giving exemestane together with pemetrexed disodium     and carboplatin may kill more tumor cells   "
123862|NCT01664741|"     The proposed research will provide significant new gender-specific information of scientific     and clinical relevance on the function of the mu-opioid system in nicotine dependence and     therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to     explain the differences in the prevalence of smoking in men and women, sex-specific     differences in nicotine craving and withdrawal as well as the poorer therapeutic response to     NRT. This work may pave the way to the design of improved pharmacotherapies that can more     effectively target the endogenous opioid system in the treatment of nicotine dependence.   "
123863|NCT01664728|"     The purpose of this study is to provide access to abiraterone acetate for patients who have     completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and     continue to receive clinical benefit from this treatment.   "
123875|NCT01664572|"     Microcirculation, especially skin microcirculation, is a window towards systemic vascular     function in magnitude and underlying mechanisms. Different techniques have been developed to     assess the microcirculation. Among these techniques, laser technology is used to perform     non-invasive microvascular assessments. Although this technique is widely used, different     methodological issues remain. This study aims at defining the way to use lasers for clinical     use.   "
125253|NCT01645839|"     The purpose of this study is to compare the neurological progression free survival with the     use of an intrathecal chemotherapy with liposomal cytarabine (DepoCyte®) in leptomeningeal     metastasis of breast cancer (versus no intrathecal treatment).   "
123864|NCT01664715|"     The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels     of recommended exercise in initially overweight and obese sedentary men and women on the     prevention of weight regain. Participants will complete a 3 mo. weight loss intervention of     decreased energy intake (EI) and increased energy expenditure (100 minutes of physical     activity per week). Participants achieving clinically significant weight loss (> 5% of     initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy     expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American     College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per     week. Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of     weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12     mos.).   "
123865|NCT01664702|"     The investigators propose a randomized trial comparing higher levels of dairy intake compared     to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13,     overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each     participant will be randomized to either higher or lower levels of dairy intake. A baseline     calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet     they have been randomized to receive for 6 days and will then have a second calorimeter stay.     During this 2nd stay, each participant will continue to receive the diet they were randomized     to receive and will achieve a 300 kcal energy deficit through physical activity. The     investigators hypothesize that children who receive a 300 kcal energy deficit from the energy     expenditure of exercise and receive 3 to 4 servings of dairy products will show greater     increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of     exercise and receive 1 or fewer servings of dairy products.   "
123866|NCT01664689|"     Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by     providing endothelial protection, maintaining space, as well as facilitating surgical     maneuvers, including IOL implantation. Equally important is the ease of use, good     visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a     single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2%     hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these     in clinical scenarios, there is no randomized trial comparing intraoperative performance and     postoperative outcomes. The aim of this study was to compare intraoperative performance and     postoperative outcomes following microcoaxial phacoemulsification when using one of the three     OVDs   "
123867|NCT01664676|"     Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against     diabetic nephropathy. We hypothesise that this is also the case in humans. This study will     investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2     diabetic patients. Impact on basic kidney physiological will be determined and kidney injury     markers will be measured as surrogate parameters of kidney protection.   "
123868|NCT01664663|"     The purpose of this study is to examine the valu of individually dose escalated radiotherapy     compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy     for patients with locally advanced non small cell lung cancer (stage III) with good     performance status.   "
123869|NCT01664650|"     The 15-25% of the population of developed countries suffers for metabolic syndrome. It is     associated with a 2-4 fold increase in cardiovascular morbility and mortality and with a 5- 9     fold increase in developing type II diabetes. MS prevalence increases after the onset of     menopause, because of estrogen deficiency. It is still not clear if menopause itself     increases the risk of cardiovascular diseases in al women or only in those that develop MS.     Many MS patients that show slight modification in cardiovascular and metabolic parameters are     not generally pharmacologically treated since diabetes or alteration in the lipid profile are     not evidenced. In this respect it is of importance to develop new therapeutic strategies to     prevent and treat MS. Genistein (4,5,7-trihydroxyisoflavone), shown a potentially preventive     role on the cardiovascular apparatus in post-menopausal women, may be termed as selective ER     modulator (SERM), since it reveals both ER-alpha full agonist and ER-beta partial agonist     activity.   "
123870|NCT01664637|"     The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given     prior to meals three times a day compared to placebo (capsule that looks like active study     drug but contains no active drug), administered for 12 weeks, in diabetic subjects with     symptoms associated with gastroparesis.   "
123871|NCT01664624|"     The purpose of this study is to assess the effect of roflumilast plus alogliptin on     glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.   "
123872|NCT01664611|"     Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the     peri/immediate post infarct period. However little is known as to the effect of repeated     remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on     ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial,     the investigators intend to carry out daily remote ischaemic conditioning in post MI     patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following     a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic     resonance imaging.   "
123873|NCT01664598|"     This open-label, single arm, multicenter long-term extension study of WA19926 will evaluate     the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to     severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible     patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104     weeks.   "
123874|NCT01664585|"     The aim of this intervention study is to examine whether tailored exercise therapy training     is effective and cost-effective to decrease headache frequency and intensity, reduce     medication used for chronic headache and patients´ absence from work, improve their neck     muscle force, cervical spine mobility, functional ability and quality of life, and increase     general physical activity in chronic headache women at regular work during a 6-month     intervention.      The intervention itself with pilot-tested upper-neck specific exercise regimen aims that     patients would independently commit to train and exercise to reduce their headache, and thus     increase their quality of life. In addition, reduced pain and frequency of headache may     increase the objectively measured daily physical activity of chronic headache patients.   "
125254|NCT01645826|"     The purpose of this study is to determine if cardizem is effective in the treatment of nitric     oxide non-responder pulmonary arterial hypertension.   "
123876|NCT01664559|"     Intrauterine device (IUD) placement can be painful for patients during and after the     procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly     effective long acting reversible contraception. Currently there are no proven effective     methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and     Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after     IUD insertion although it is used by some providers for this purpose. It is a strong NSAID     that is indicated for the treatment of moderate acute pain. In the intramuscular form it has     an analgesia onset of action at 30min, thus may be a plausible option for pain management in     the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia     and have not been proven to be effective in reducing pain associated with IUD placement. The     primary aim of this study is to determine whether ketorolac (Toradol) decreases pain     associated with intrauterine device placement compared to placebo. We hypothesize that     administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion     will decrease pain scores by at least 20mm on a visual analog scale at various time points     during IUD insertion when compared to placebo of normal saline injection.   "
123877|NCT01664546|"     An Observational, blind and prospective study of Preimplantational Aneuploidy Screening by     aCGH in Trophectoderm Biopsy   "
123878|NCT01664533|"     This prospective, multicenter observational study will evaluate the efficacy, safety, and     tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally     advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after     pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until     withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.   "
123879|NCT01664520|"     The purpose of this study is to investigate how dexmedetomidine affects static and dynamic     autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal     subarachnoid haemorrhage (SAH) patients.   "
123880|NCT01664507|"     Croup is common illness presenting emergency department with dyspnea. The main treatment for     croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized     L-epinephrine is restricted that the study of comparision between racemic epinephrine and     L-epinephrine.      The investigators conducted this study to compare the effectiveness of low dose L-epinephrine     with conventional dose L-epinephrine.   "
123881|NCT01664494|"     This multi-center observational study will evaluate the use of Xeloda (capecitabine) in     patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced     gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving     treatment with Xeloda according to product label will be followed for up to 10 months.   "
123882|NCT01664273|"     Gene transfer by electroporation (gene electrotransfer) uses short electric pulses to     transiently permeabilise the cell membrane enabling passage of plasmid DNA into the cell     cytosol. It is an efficient non-viral method for gene delivery to various tissues. In this     phase I dose-escalating study, patients will be treated with intramuscular gene     electrotransfer of plasmid AMEP. Plasmid AMEP encodes protein AMEP which bind to α5β1 og αvβ3     integrins. Primary end point of the trial is safety and secondary end points are efficacy,     pharmacokinetics and evaluation of potential discomfort associated with the treatment     procedure using VAS (Visual Analogue Scale).   "
123883|NCT01664260|"     It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating     neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine     augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well     as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will     induce change in structural, functional, and neurochemical aspects of the brain.      In this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation     study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and     safety of the N-acetylcysteine augmentation.   "
123884|NCT01664247|"     This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial     is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide     (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type     2 diabetes qualifying for treatment intensification.   "
123885|NCT01664234|"     Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study.     Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins,     trisomy 21, or similar congenital malformations. Patients with American Society of     Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital     heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy     with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by     a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.     Randomization (1:1) will be based on computer-generated codes with random block sizes and     stratified by hospital; allocation will be concealed and provided to clinicians via a secure     web site that will be accessed shortly before induction of anesthesia.   "
124183|NCT01660503|"     Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in     rats and in adolescent boys and girls.   "
123886|NCT01664221|"     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects     following administration of multiple intravenous dose. The objective of this randomized,     parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of     the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug     Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the     reticulocyte count following a multiple intravenous administration during 4 weeks of 100     IU/kg in healthy subjects.   "
123887|NCT01664195|"     The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and     pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects     following administration of single intravenous dose. The objective of this randomized,     crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of     the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced     by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count     following a single-dose intravenous administration of 100 IU/kg in healthy subjects.   "
123888|NCT01664182|"     This randomized phase II trial studies how well trebananib with or without bevacizumab,     pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate works in treating patients     with kidney cancer that has spread to other places in the body and usually cannot be cured or     controlled with treatment. Trebananib may stop the growth of tumor cells by blocking blood     flow to the tumor. Bevacizumab, pazopanib hydrochloride, sorafenib tosylate, and sunitinib     malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth or by blocking blood flow to the tumor. It is not yet known whether giving trebananib     with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate     is more effective in treating kidney cancer.   "
123889|NCT01664169|"     RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic     cancer treated on study CALGB-80303.   "
123890|NCT01664156|"     1. Objectives             1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet               in women             2. to establish scientific evidence for the use of Korean red ginseng by investigating               changes of infrared thermography        2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity          of hands and feet more effectively than placebo after 8 weeks administration of          interventions- Korean red ginseng or the placebo.   "
123891|NCT01664143|"     This single-center, randomized, double-blind, placebo-controlled study will evaluate the     safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers     will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time     on study treatment is 14 days.   "
123892|NCT01664130|"     This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating     patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able     to send x-rays directly to the tumor and cause less damage to normal tissue   "
123893|NCT01664117|"     This observational multicenter study will evaluate the management of disease and safety in     clinical practice in patients with moderate to severe rheumatoid arthritis receiving any     biological therapies in monotherapy.   "
123894|NCT01664104|"     This observational, multi-center study will evaluate the treatment regimen, treatment     responses and safety of tocilizumab therapy in a routine clinical practice in participants     with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a     maximum study duration of 18 months.   "
123895|NCT01664091|"     This research study is being done to carefully evaluate the effect of giving radiation     therapy after temporary breast reconstruction. The investigators want to see if this type of     reconstruction combined with radiation will look better (once the final reconstruction has     been completed) and will reduce the risk that the participant will develop complications that     sometimes occur with other kinds of reconstruction procedures. The investigators also want to     know if it is easier to give the radiation with this type of reconstruction than with other     kinds of reconstruction procedures. The reconstruction procedure involves the temporary use     of a tissue expander and an acellular dermal matrix (ADM).   "
123896|NCT01664078|"     The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects     with abdominal aortic aneurysms requiring endovascular repair.   "
123897|NCT01664065|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     Ceftaroline in a group of patients with renal disease and matching healthy subjects with     normal renal function   "
123898|NCT01664052|"     This study has been designed to evaluate an investigational model of the Essure System for     Permanent Birth Control. The investigational device is designed to offer all the advantages     of the currently approved device. In addition, the investigational device offers immediate,     permanent contraception without a three-month waiting period or 90-day confirmation test.     This study has been designed to evaluate the effectiveness of the investigational device in     causing tubal occlusion from insert placement through three months of wearing.   "
123899|NCT01664039|"     The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular     pressure (IOP) and ocular surface and inflammatory biomarkers.   "
123900|NCT01664026|"     To evaluate the effect of a 6-month web-based lifestyle modification program with and without     telephone counseling versus usual care in obese patients with cardiovascular risk factors on:        -  Weight Loss        -  Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol,          HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.        -  Physical activity and eating habits        -  Quality of life   "
123901|NCT01664013|"     The purpose of this study is to investigate the impact of botulinum toxin treatment in     quality of life(QoL) in cervical dystonia patients   "
124238|NCT01659567|"     This prospective observational study will investigate predictive values of virological     response in peginterferon/ribavirin treatment-naive patients with chronic hepatitis C.     Patients will be treated with Pegasys (peg-interferon alpha 2a) and Copegus (ribavirin) as     prescribed by the physician. Data will be collected for 72 weeks.   "
123902|NCT01664000|"     In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important     role in protecting the body. p53 functions by activating proteins that repair DNA and kill     cells that have genetic mutations such as in cancers. Research experiments showed that when     cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that     inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis),     a protein that causes tumor cell death. Because of these activities, slowing cancer cell     growth and causing cancer cell death, Kevetrin may help to treat tumors.   "
123903|NCT01663987|"     A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess     the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in     Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an     acute exacerbation (Hospital Discharge 1)   "
124091|NCT01661595|"     This study is funded by the Moody Endowment. In this project, we will investigate the     potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle     anabolism, muscle strength, physical function, and body composition in older individuals.     Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and     fatigability.   "
123904|NCT01663974|"     The study aims to evaluate:        -  the frequency of subsyndromal symptoms or disorders observed during interepisode phases          in bipolar patients, particularly after a depressive episode in which these subsyndromal          disorders are the most frequent        -  the functional impact of these disorders, factors or symptom thresholds associated with          functional remission, and factors associated with symptomatic remission over a          sufficient follow-up (12 months).   "
123905|NCT01663961|"     A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on     YM178, when the latter is taken on a continuous basis, in order to establish that there is no     risk to patients who may take this combination of drugs.   "
123906|NCT01663948|"     The purpose of the international plastic bronchitis registry is to understand the natural     course and long term health outcomes of subjects diagnosed with plastic bronchitis due to     different types of casts. This provides essential data for identifying best practices and     treatments. The secondary aim is to understand the structure of casts and mechanism of their     formation.   "
123907|NCT01663935|"     The purpose of the study is to evaluate and document physiologic and functional changes in     visual performance and retinal function of patients diagnosed with albinism (a dopamine     deficiency state) following a trial of oral Levodopa/carbidopa treatment.   "
123908|NCT01663922|"     The purpose of the study is to look at whether taking a new medication for hepatitis C     (boceprevir) together with a herbal remedy commonly used for the treatment of depression     (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is     taken on its own.      Treatment of hepatitis C genotype-1, has recently been significantly improved with the     addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this     class of antiviral drugs and it is administered in combinations with other drugs to treat     hepatitis C. One of the common side effects of treatment for hepatitis C is low mood     (depression) for which treated patients may self-medicate with preparations containing St.     Johns Wort (SJW).      SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may     result in a change in how both of these drugs usually work. It is therefore important to find     out if the levels of boceprevir in the blood are significantly affected by taking SJW.      The study aims to help us understand whether it will be safe to take SJW whilst being     simultaneously treated for hepatitis C with boceprevir.   "
123909|NCT01663909|"     Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain     management a complex task. Several studies have found out that pharmacological interventions     alone were not enough to provide optimal pain management for these patients. The     investigators developed a DVD on guided imagery, customized for teenagers, to help them cope     better with their pain. The investigators believe that this type of intervention combined     with their usual analgesic medication will help them to control their pain and foster     rehabilitation.   "
123910|NCT01663896|"     To define and evaluate OCT stent guidance parameters through prospective data collection in     PCI procedures of de novo lesions.   "
123911|NCT01663883|"     Constant despite changes in perfusion pressure. It is observed in many vascular beds of the     human body to prevent that variations in perfusion pressure are directly transmitted into     changes in blood flow. This is necessary to prevent ischemia and/or hypoxia during decreased     blood flow and bleeding or increased capillary pressure during increased blood flow.      In the eye, several studies have reported that retinal blood flow is autoregulated over a     wide range of ocular perfusion pressures. Unfortunately only few data are available for the     optic nerve head. To gain data about autoregulation is of special importance given that     several important ocular diseases such as glaucoma and age-related macular degeneration are     associated with impaired autoregulation. In humans most data were collected using laser     Doppler flowmetry.      The present study aims to investigate the phenomenon of transient reduction in blood flow and     to gain insight in the regulatory mechanisms of optic nerve head blood flow during isometric     exercise.   "
123912|NCT01663870|"     The goal of this research study to learn about breast cancer survivorship and possible ways     to improve breast cancer survivorship programs using technology.      Objectives:      Objective 1: Assess breast cancer survivors on the acceptability of and preferences for the     integration of patient navigation and an eHealth technology platform to improve care in the     Survivorship Clinic at Lyndon B. Johnson Hospital.      Objective 2: Assess clinic stakeholders acceptability of and preferences for the integration     of patient navigation and an eHealth technology platform to improve care for breast cancer     patients in the Survivorship Clinic at Lyndon B. Johnson Hospital.   "
123913|NCT01663857|"     A study for women with ovarian cancer that has returned at least 6 months after     platinum-based chemotherapy.   "
123945|NCT01663441|"     This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the     optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter     randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of     Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11     (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240     cancer patients undergoing chemotherapy.   "
123946|NCT01663428|"     This study evaluates the ability of a newly designed splint called Sup-ER Splint to improve     the arm function and anatomy of children with birth related brachial plexus injuries.   "
123914|NCT01663844|"     This study includes two sub-trials. Both are included in this singe registration since they     have parallel inclusion of participants and have been approved by the Swedish ethics board     together in one application.      Trial 1 includes patients with both insomnia and major or minor depression. Participants are     randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or     to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The     primary purpose is to evaluate changes in insomnia and depression severity for the     combination treatment compared to the depression treatment, after treatment and at 6 and 36     months follow up. A secondary purpose is to evaluate cognitive functioning before and after     treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through     mass media and the Internet psychiatry clinic's regular patient recruitment.      Trial 2 includes patients with insomnia who do not meet criteria for major or minor     depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks     patients that are judged to be at risk of treatment failure are randomized to either     continued treatment or treatment with added support intended to enhance outcome. The primary     purpose is to evaluate change in insomnia severity for participants who get added support,     compared to continued treatment with regular support level. A secondary purpose is to     evaluate cognitive functioning before and after treatment, as well as cost effectiveness.     Recruitment is done in the Stockholm County through mass media and the Internet psychiatry     clinic's regular patient recruitment.      NOTE:      The first participants in trial 1 will be regarded as pilots, due to problems with the     experimental treatment: technical issues as well as problems with the design of treatment     modules. These problems were corrected when discovered. 12 participants in the experimental     arm were affected by these errors. The pilot participants will not be included in the main     analyses of data. This was decided upon on 31st of October 2014.   "
123915|NCT01663831|"     The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual     Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these     control methods tackle only indoor and night biting vectors. The proportion of transmission     occurring outdoors and before sleeping hours or so-called residual transmission is steadily     increasing and may compromise the effort towards malaria elimination.      The purpose of this study is to raise evidence on the effectiveness of mass use of topical     repellents in addition to LLINs in controlling malaria infections.      A multidisciplinary approach will be used to collect information on the most important     factors that contribute to the successful reduction of residual malaria transmission. In a     first objective the epidemiological efficacy of repellents on prevalence of malaria carriers     and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly     assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a cross     sectional random sample of 65 people will be drawn at the beginning and the end of the     malaria season to obtain an estimate of the malaria prevalence. The second objective will     handle the entomological efficacy and persistence of the topical repellent on malaria     vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will     be studied in a third objective.   "
123916|NCT01663818|"     A multi-center, post-CE Mark study designed to evaluate the performance of the Intact     Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.;     post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty     (PTA) of superficial femoral or popliteal artery(ies).   "
123917|NCT01663805|"     This is an open, randomized, single-center study. The selected patients will be first divided     into two major groups according to the type of organ to be transplanted: standard criteria     donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to     one of the treatments: tacrolimus (TAC) or everolimus (EVL).      All patients received induction therapy with basiliximab (BXB) and maintenance with     Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary     objectives: To characterize the molecular profile of cytokines in kidneys obtained from     deceased donors such as standard (SCD) and extended criteria (ECD) in biopsies taken before     and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in     the expression of these molecules. And as Secondaries objectives: To correlate the pattern of     cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection     and patient and graft survival.   "
123918|NCT01663792|"     Could daily consumption of seaweed help explain lower postmenopausal breast cancer (BC)     incidence and mortality rates in Japan? This small proof of principle clinical trial was     designed to test the idea that the same amount of seaweed normally eaten in Japan would     induce metabolic changes when given to non-seaweed consuming healthy postmenopausal American     women. The participants were given 10 capsules a day (about 1 tablespoon) for 3 months.     During the first month the capsules contained placebo, the second month seaweed, and the     third month placebo. We collected blood and urine samples after each treatment period and     tested for changes in protein expression that might be related to consuming seaweed.   "
123919|NCT01663779|"     Arterial catheterization is frequently performed on critically ill patients for invasive     blood pressure monitoring and/or frequent blood draws, especially arterial blood gas     analysis. The distal part of the radial artery (wrist) is the preferred access site.      The potential complications of the procedure are mostly minor and comprise temporary     occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture     site. Major complications including vessel aneurysm or occlusion with threat to hand     viability are rare.      The standard approach to catheterization is blind puncture of the RA while locating its     pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel.     Alternatively ultrasound can be used to locate the vessel and guide needle insertion.      To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with     ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked     at the pooled data obtained from these. The results showed that ultrasound guidance increased     the first-attempt success rate at RA catheterization by 71% compared to palpation. The use of     ultrasound also significantly reduced the time to successful catheterization, the number of     punctures as well as the amount of catheters required per procedure.      None of the prior randomized trials has been conducted in an ICU setting and in three out of     the four studies the arterial lines were placed in patients undergoing elective surgery. The     investigators hypothesized that ultrasound could improve first attempt success rate while     placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to     successful insertion and reduce complications.      The investigators plan to randomize patients to either a palpation technique or ultrasound     guided catheter insertion and record the above outcomes.   "
123920|NCT01663766|"     This study will assess the safety and tolerability of milatuzumab (IMMU-115) when added to a     standard regimen to prevent Graft vs. Host Disease (GVHD) in patients with hematologic     malignancies undergoing stem cell transplant.   "
123947|NCT01663415|"     The purpose of this study is to investigate radiographic progression-free survival (PFS) of     enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant     prostate cancer who have symptomatic disease.   "
123948|NCT01663402|"     Primary Objective:      To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events     (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction     (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in     patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to     randomization and are treated with evidence-based medical and dietary management of     dyslipidemia.      Secondary Objectives:        -  To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD          event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic          stroke, all cause mortality).        -  To evaluate the safety and tolerability of alirocumab.        -  To evaluate the effect of alirocumab on lipid parameters.   "
123993|NCT01662817|"     The purpose of this study is to assess the effectiveness of systematic screening for     depression in high-risk patient participants in everyday clinical practice. Systematic     screening for depression in high-risk patients is recommended to be included as a usual     practice but its effectiveness in this context remains controversial. In this study, 35     primary care physicians (PCPs) in Spain were assigned to intervention (receive one day     training in depression screening guidelines and use guidelines for six months) and 34 PCPs     were assigned to a control group (manage depression in the usual way for six months). There     were a total of 525 patient participants with MDD.   "
124036|NCT01662323|"     The purpose of this study is to determine whether it is possible to improve the care of     general practitioners for patients with heart failure. The investigators try to reach that     goal by training the GP's for 90 minutes in uptitrating the recommended medication according     the guidelines. After 6 month the investigators ask the patients to fill out a questionary.     The investigators ask them about their quality of live.   "
123921|NCT01663753|"     Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and     brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment.     Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to     treatment before surgery. A positive predictive value of 75% was found in a small study     making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach.     Diffusion-weighted MRI was also described as an early and sensitive indicator in other     diseases.      Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in     the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary     objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted     MRI diagnostic performances.      Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2     cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a     18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the     brachytherapy. The total follow-up duration (study participation) of patients will be 11     weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until     18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.      Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to     assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it     could improve clinical practices and be helpful to decide whether the patient needs surgery     or not after radiochemotherapy and brachytherapy.   "
123922|NCT01663740|"     This observational study will compare spermatogenesis in male adult renal transplant     recipients receiving valganciclovir versus untreated matched controls. Data will be collected     from each patient for up to 52 weeks post transplant.   "
123923|NCT01663727|"     This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to     evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel     in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast     cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All     patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks     during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV     infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease     progression, unacceptable toxicity or death from any cause occurs.   "
123924|NCT01663714|"     This is a phase II, open-label, multicenter study of the efficacy and safety of sequential     administration of CVP x 6 followed by tositumomab and iodine I 131 tositumomab (formerly     referred to as tositumomab and iodine I 131 tositumomab). All patients who complete three     cycles of CVP, regardless of response, will be eligible for treatment with tositumomab and     iodine I 131 tositumomab. Subjects who have rapidly progressive disease prior to completing     three cycles of CVP may be removed from study.      In order to proceed to tositumomab and iodine I 131 tositumomab therapy, patients must have     completed six cycles of CVP within 20 weeks as described. Patients may proceed to Iodine-131     Anti-B1 Antibody if they have progressive disease documented at the response evaluation     following 6 cycles of CVP. In addition, patients must still meet the eligibility inclusion     exclusion criteria based upon the week 20 assessments, as applicable. Patients must also have     an average of ≤25% bone marrow involved by NHL to receive treatment with tositumomab and     iodine I 131 tositumomab. The dosimetric dose of tositumomab and iodine I 131 tositumomab     must be given within 28 days of the response evaluation following CVP and no later than 56     days from the first day of the sixth cycle of CVP.   "
123925|NCT01663701|"     This study is a randomized control trial assessing the impact of a simple evidence-based     protocol for the treatment severe sepsis with hypotension in Zambia. This is a follow-up     study to the Simplified Severe Sepsis Protocol (SSSP) study. The intervention protocol     consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and     blood transfusion when necessary. It is hypothesized that the protocol will significantly     decrease in-hospital mortality in patients with severe sepsis and hypotension.   "
123926|NCT01663688|"     The purpose of this clinical study is to collect and evaluate the data from eye scans using     an investigational three-dimensional eye imaging photography device called the Nidek Optical     Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique     that uses invisible wavelengths of light to make detailed images of the tissues at the back     of the eye. These images provide information that physicians may use to help diagnose eye     conditions and/or to monitor changes in the eye during treatment.   "
123927|NCT01663675|"     Trisomy 21 or Down syndrome, is the most common genetic cause of cognitive disability.     Currently, in Alsace, the birth prevalence is about 1 in 1600 live births, which means 10     liveborns with Down syndrome each year.If screening and prenatal diagnosis of children with     trisomy 21, as well as medical care, social and educational integration in childhood was the     subject of much research and has led to remarkable progress in terms of health and medical     care, it is not the same for the knowledge about adolescents and adults.Despite a more and     more higher life expectancy, the evolution of trisomy 21 in adulthood is often marked by a     deterioration in health status, with a regression of acquired psychomotor skills, often     attributed only to the precocious occurrence of Alzheimer's dementia. Nevertheless, it seems     that the diagnosis of Alzheimer's dementia is often overdiagnosed, and it is well established     that only a fraction of Down syndrome patients will develop this type of dementia. Too often     a decline in general health, behavioral changes and decreased cognitive abilities are only     attributed to the Down syndrome with an early dementia without looking for an underlying,     potentially curable, disease.This study aims to better evaluate the health and social status     of 100 adults with trisomy 21 in Alsace. The medical evaluation will include a comprehensive     assessment of health status and quality of life conducted by the geneticist, a cardiac,     sensory, hormonal, biological and radiological evaluation. A speech-language and psychomotor     evaluation will also be conducted. A psychiatric consultation and a psychometric assessment     will aim to assess cognitive function and to search for associated mood disorders.The     expected results are to better know the natural history of trisomy 21 in adulthood, with the     determination of the frequency of morbid events specific to adulthood, and also to improve     the medical and paramedical care with the establishment of a monitoring program to prevent     the occurrence of these morbid events.   "
123964|NCT01663194|"     Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with     adverse outcomes among patients with coronary artery disease, its role during the acute phase     of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This     study sought to investigate the association of the pre-procedural N/L ratio within-hospital     and long-term outcomes among STEMI patients undergoing primary percutaneous coronary     intervention (PCI).   "
124239|NCT01659554|"     The primary objective of this study is to investigate the feasibility, tolerability and     safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC)     followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary     peritoneal, and fallopian tube carcinomas.   "
123928|NCT01663662|"     It is well known that the use of loop diuretics in acute setting may decrease glomerular     filtration rate (GFR) and increase serum creatinine leading to renal dysfunction. Loop     diuretic induced elevation in serum creatinine can lead to increase in length of hospital     stay and possibly morbidity. Previous studies have suggested that tolvaptan unlike aggressive     loop diuretic therapy may not activate neurohormonal system nor decrease renal blood flow.     These properties may make tolvaptan a useful addition to diuretic therapy to prevent renal     dysfunction in high-risk patients. Therefore the primary objective of this study is to     determine if the use of tolvaptan in combination with diuretic therapy may prevent     development of renal dysfunction in high risk patients with heart failure.      Hypothesis: Administration of tolvaptan in combination with continuous loop diuretic therapy     in acutely decompensated heart failure patients at high risk for developing diuretic induced     renal dysfunction will have a lower proportion of patients increasing their serum creatinine     > 0.3 mg/dL within a 96 hour time frame as compared to patients just receiving standard of     care continuous infusion diuretic.   "
123929|NCT01663649|"     200 persons (100 with multiple sclerosis and 100 with epilepsy) with depressive symptoms are     recruited via the multiple sclerosis clinics of the University Medical Center     Hamburg-Eppendorf and the epilepsy centre Alsterdorf and randomly assigned either to the     online program deprexis or to a wait-list control condition. All participants receive     free-of-charge online access to deprexis either immediately or with a six month delay.      At three time points (1. prior to intervention, 2. after completion of the intervention nine     weeks later and 3. at follow-up six month later), both groups are assessed via an anonymous     online survey, which was implemented using the software package OPST®.      The survey consists of different questionnaires. The Beck Depression Inventory (BDI)     represents the primary outcome (IIT analysis for pre versus post). It is assumed that the     severity of depressive symptoms will improve to a significantly greater extent in the     deprexis than in the wait-list control condition in the course of nine weeks and will be     maintained in a six month follow-up.   "
123930|NCT01663636|"     To pilot test a mobile phone SMS system that will provide periodical messaging texts to     mothers or custodians of infants who come for their first dose vaccines within the first 3     months of life to improve timely immunization coverage, vaccine acceptance and ensure vaccine     safety monitoring. The intervention will include a cloud-based information system alimented     by mobile phone data entry at the health post nurse level, that links child vaccination     status and is able to remind parents and nurses of the need for next vaccination appointment     and provide a system for reporting of adverse events following immunization in the immediate     post-vaccination period.   "
123931|NCT01663623|"     The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination     with azathioprine, for the maintenance of remission following a standard induction regimen in     patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in     this study is 1 to 1 which means that participants have an equal chance of receiving     belimumab or placebo.   "
123932|NCT01663610|"     This study is a randomized controlled trial (RCT) to evaluate the effect of an     internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis or     struggle with organizing daily life and/or easily get distracted. The course (vardagsSMART)     teach the participants how to use a Smartphone to better organize their everday life and will     be compared to a wait list control group (CONT) that later will recieve the same course     without guidance from a supervisor(selfSMART). It is hypothesized that VardagsSMART will be     superior to CONT on ability to organize everyday life and ADHD-symptoms, and that     vardagsSMART will be superior to selfSMART on adherence, understanding and perecived     usefullness.   "
123933|NCT01663597|"     Aberrations play a significant role in the visual process and can be divided in lower-order     and higher-order aberrations. The former can be measured using the commercially available IOL     Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity.     Higher-order aberrations do not significantly influence visual acuity but affect the quality     of vision and can cause halos, double vision, and night vision disturbances.      Background Cataract surgery has become a routine procedure in the developed countries. During     this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However,     these lenses do not account for individual optical biometry data or aberrations. Therefore,     it is important to provide data for ametropic and emmetropic eyes as this information might     improve future intraocular lens design and lead to individually adapted lenses for yielding     optimal visual acuity and quality results.      The aim of the present study is to clarify the correlation between refractive errors/axial     eye length and spherical aberrations of the cornea.   "
123934|NCT01663584|"     The purpose of this study is to collect blood samples to enable validation of genetic testing     for diseases within a multi-disease carrier screening panel. Samples will be collected from     adult women or men who have previously tested positive as carriers for various recessive     conditions. These are healthy adults who carry a mutation that might place them at increased     risk of having a child with a specific genetic disorder. Study participation will be open to     adults that were previously tested as part of their routine medical care and where test     results demonstrated positive carrier status for a specific genetic disease. Samples will be     tested for the disease mutation for which the subjects provides documentation of prior     testing.   "
123959|NCT01663259|"     Taking into account the excellent prognosis of patients with HPV-positive oropharyngeal     cancer with < 10 pack-year smoking, the investigators hypothesize that reducing the intensity     of therapy for these patients will reduce treatment sequelae, notably long-term dysphagia,     without affecting their cure rates. The main Aim is to assess whether reducing treatment     intensity, by replacing concurrent chemotherapy with cetuximab, will indeed achieve improved     long-term toxicity.      The primary objectives include the following: to confirm that reducing treatment intensity in     patients with HPV-related oropharyngeal cancer and < 10 pack-year smoking history by     replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase     the proportion of patients whose tumors recur, compared to our previous experience in similar     patients receiving chemo-RT and to compare the toxicity in patients receiving cetuximab-RT to     similar patients treated with 7 weeks of chemotherapy concurrent with RT (standard therapy)     in UMCC 2-21.   "
124240|NCT01659541|"     The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire     leads, to produce an effective cough in patients with spinal cord injuries.   "
123935|NCT01663571|"     Protocol Summary      Constitutive STAT3 activity is implicated in many malignancies including Cutaneous T Cell     Lymphoma. It is also essential for Th17 differentiation, a subset of CD4 effector T cell,     implicated in chronic inflammatory conditions and possibly CTCL. HDAC inhibitors have shown     activity in CTCL but their exact mechanism of action is not known. It is known that HDAC     inhibitors regulate STAT3 transcriptional activity and hence can potentially be active in     CTCL through modulation of the STAT3 pathway. The hypothesis is that Th17 cytokines     contribute to the initiation of cancer by creating a pro-inflammatory microenvironment that     predisposes cells to neoplastic transformation. To probe this, the investigators will compare     the differences in cytokine production and gene expression in the skin resident T cells from     patients with benign dermatoses and CTCL as well as in the blood/circulating lymphocytes of     healthy donors and Sezary syndrome (SS). The investigators will also investigate whether HDAC     inhibitors have a direct impact on the number of Th17 cells, the cytokine production by these     cells and phosphorylated STAT3 protein in CTCL with subsequent treatment cycles.      The objectives of this study are 1. Observe the epigenetic, transcriptional and phenotypic     changes that take place in T cell during malignant transformation 2. Understand the mechanism     of action of HDAC inhibitors in CTCL.      Methods: Skin biopsy specimens from cutaneous T cell lymphoma (CTCL) patients and benign skin     conditions namely eczema, dermatitis and psoriasis will be obtained through a standard punch     biopsy procedure from the skin lesion.      Additionally, 15 ml of peripheral blood from CTCL patients who have Sezary syndrome (SS) and     from patients with benign skin condition will be collected.      CTCL patients, who are starting treatment with HDAC Inhibitors namely Vorinostat and     Romidepsin, will have a total of 3 skin biopsies and/or blood draws. The first procedure     would be before starting treatment with either of these HDAC inhibitors. Two more skin     biopsies and/or blood draws will be performed after first and second cycle of treatment.      Levels of Th17 cytokines, IL-17, IL -22 and pSTAT3 protein will be determined by IHC staining     in the skin and cytokine levels in the blood will be assayed by sandwich ELISA method.The     investigators will also assay the mRNA levels of the transcription factors of the different T     effector cells by qPCR.   "
123936|NCT01663558|"     Context:      Men who have sex with men (MSM) are at increased risk for HPV-related anal neoplasia and anal     squamous cell carcinoma; concomitant HIV infection roughly doubles that risk.      Objectives:        1. To compare the efficacy of ablative therapy to topical imiquimod therapy in the          management of anal dysplasia in HIV-infected men.        2. To describe relationship between cytologic grade of anal dysplasia (as reported on          screening anal Pap test) and pathologic grade reported on anal mucosa histopathologic          examination.        3. To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of          anal dysplasia.        4. To describe adverse effects associated with ablative therapy and topical imiquimod          therapy.      Design:      Prospective, randomized controlled clinical trial. This will be a pilot study. All subjects     will undergo baseline anal Pap, HRA with biopsies as indicated, and anal HPV testing. If AIN     2 or 3 is discovered on histopathologic examination, subject will be offered observation only     or treatment. If he chooses treatment, he will be randomized to: 1) imiquimod anal     suppositories three times weekly for 3 months, or 2) appropriate ablative therapy as     determined by colorectal surgeon. During imiquimod treatment (not applicable to ablative     group as their treatment will be completed in one visit) subjects will be followed for 2     weeks, 4 weeks, 8 weeks, and 12 weeks with anal Pap, HRA with biopsies as indicated, and anal     HPV testing. After therapy completed in each treatment group, subjects will be followed for 1     month, 3 months, 6 months, 9 months, and 12 months post-therapy with anal Pap, HRA with     biopsies as indicated, and anal HPV testing. Observation only subjects will be evaluated     every 3 months with anal Pap, HRA with biopsies as indicated, and anal HPV testing for 12     months. We have chosen a goal of 30 subjects in each treatment group and 10 subjects in the     observation only group based on the likelihood of enrolling a study of this type in a     reasonable amount of time.      Main Outcome Measures:        1. Anal Pap cytologic grade, including regression and recurrence during course of study        2. HPV type in anal canal, including regression and recurrence during course of study        3. Anal histology, including regression and recurrence during course of study        4. Adverse effects experienced during treatment, recorded in symptom log   "
123937|NCT01663545|"     Background:        -  The brain is protected by a barrier that keeps toxins in the blood from reaching the          brain. However, this barrier can also keep useful medications from reaching the brain.          P-glycoprotein (P-gp) is a brain protein that is part of the blood-brain barrier. The          level of P-gp is higher in people with epilepsy than in people without epilepsy. These          different levels of P-gp may explain why some people have seizures that do not respond          well to medications. Researchers want to see if P-gp can affect the response to epilepsy          medications.        -  Epilepsy may also be associated with brain inflammation. Researchers also want to look          at the part of the brain affected by epilepsy to see if inflammation is present.      Objectives:        -  To see if P-gp can affect the response to epilepsy medications.        -  To see if inflammation is present in the part of the brain affected by epilepsy.      Eligibility:        -  <TAB>Individuals between 18 and 60 years of age who have temporal lobe epilepsy. We plan          to study some patients whose seizures are well controlled by drugs, and some whose          seizures are not controlled.        -  <TAB>        -  Healthy volunteers between 18 and 60 years of age.      Design:        -  This study requires four or five visits to the NIH Clinical Center over the course of a          year. The visits will be outpatient visits and will last from 2 to 5 hours.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  All participants will have two positron emission tomography (PET) scans. The scans will          take place during different visits. Different drugs will be used in each scan. One drug          will be used to temporarily block the effect of P-gp in the brain. The other drug will          show areas of inflammation in the brain.        -  Participants with epilepsy will have a third PET scan. This scan will also look at P-gp          activity in the brain. However, it will not use the drug that blocks the effect of P-gp.        -  All participants will also have one magnetic resonance imaging scan. This scan will help          show brain function.   "
123938|NCT01663532|"     The primary purpose of this study is to evaluate the overall efficacy of aripiprazole     intramuscular (IM) depot as acute treatment in subjects with schizophrenia.      The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot     administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.   "
123939|NCT01663519|"     Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients     at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1%     to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines     Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the     feet, education and prescription of insoles in combination with well fitting shoes are     supposed to decrease the risk of ulcers and prevent amputation. Further research is, however,     needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this     study is to compare three different types of insoles with respect to pressure distribution.     Every 6 months follow-up is assessed until 24 months is reached.   "
123940|NCT01663506|"     This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra     (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients     initiated on RoActemra/Actemra treatment according to the local label will be followed for 12     months.   "
123941|NCT01663493|"     This study will examine whether there is any difference in number of passes needed to     diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different     types of needles.   "
123942|NCT01663480|"     The primary purpose of mechanical ventilation is to sufficiently unload the respiratory     muscles and maintain adequate ventilation in spontaneously breathing patients. When the     mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the     patient and the mechanical ventilator will contribute to the lung-distending pressure,     necessary to overcome inspiratory load and generate the tidal volume (Vt). Unfortunately,     conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory     assist performed by the ventilator and the patient. Inadequate levels of assist are     associated with adverse effects such as development of fatigue or patient-ventilator     dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and     weaning delay.      The newly introduced neurally adjusted ventilatory assist (NAVA) has made it possible to     measure the neural activity of the respiratory centers (expressed by the diaphragm electrical     activity, EAdi). EAdi is a validated variable to quantify the neural respiratory drive,     little is known about its usefulness to evaluate the contribution of the patient's     inspiratory muscle effort relative to that of the mechanical ventilator, which would be of     crucial importance to appropriately titrate the level of assist.      During NAVA, the patient's efficiency to transform neural effort (EAdi) into Vt, expressed as     neuroventilatory efficiency (NVE), may be a useful predictor for determining the contribution     of the patient and the ventilator to generate a breath.   "
123949|NCT01663389|"     This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study.     This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion,     and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of     blood, urine, and feces.      Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day     screening period, two dosing periods (approximately 8 days each) and a follow up visit.      The subjects will be admitted to the clinical unit on Day 1 of the first treatment period and     remain in the unit for up to approximately 16 days through the end of the second treatment     period.      On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single     therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is <1%     of the administered dose in all subjects, Period 2 dosing will begin (approximately 8 days     after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic oral     solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during both     the periods. The subject may be discharged from the unit as early as Day 8 of Period 2.     Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge     from the unit.   "
123950|NCT01663376|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with     critical limb ischemia   "
123951|NCT01663363|"     The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and     effective for the correction of myopic refractive errors.   "
123952|NCT01663350|"     This is a prospective, multi‐center observational study designed to compare the test results     of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening     for fetal chromosome abnormalities in 'all-risk' pregnancies.   "
123953|NCT01663337|"     The broad, long-term objective of the current research is to improve treatment outcomes for     individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and     dependence (AUD).      The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and     cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP)     treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.      The study will randomize 235 PTSD/AUD participants recruited from the VA and from the     community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the     AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals     will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months     post-treatment and will monitor symptoms daily throughout treatment.   "
123954|NCT01663324|"     Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory     neural pathways contributing to the perception of phantom sounds.   "
123955|NCT01663311|"     Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways     contributing to the perception of phantom sounds, and the regulatory neural network     responsible for the generation of the individual amount of suffering caused by chronic     tinnitus.   "
123956|NCT01663298|"     Periodontal wound healing is a complex multifactorial process that involves interactions     among various cells, growth factors, hormones and extracellular matrices. Although still     poorly understood, these interactions trigger a series of events that lead to new tissue     formation. One growth factor that plays an important role in wound healing is fibroblast     growth factor 2 (FGF2). Many animal and human studies have shown this protein is effective in     periodontal regeneration. Recently, epigenetic modifications, such as DNA methylation, have     been associated with changes in patterns of gene expression. Preliminary data suggests that     FGF2 gene may be differentially methylated in periodontal tissues. Aberrant gene promoter     methylation in smokers and diabetics has also been reported in many studies. However, the     role of DNA methylation in wound healing has not yet been investigated.      The investigators hypothesize that the methylation status of FGF2 gene can affect the levels     of FGF2 secreted during wound healing phase after dental implant surgery. The investigators     also hypothesize there exists a difference in methylation levels of FGF2 gene in healthy,     smoking and diabetic patients that can interfere with wound healing. The investigators seek     to determine whether DNA methylation plays a role in wound healing and whether the     methylation level of FGF2 gene varies among healthy, smoking and diabetic patients.   "
123957|NCT01663285|"     The main purpose of this study is to look at the cancer-free survival at two years of     subjects with high risk upper tract urothelial cancer when treated with the combination of     two chemotherapy drugs called Gemcitabine and Cisplatin followed by surgery to remove the     kidney, all or part of the ureter (ureters are tubes made of smooth muscle fibers that propel     urine from the kidneys to the urinary bladder), and a cuff of bladder where the ureter drains     into the bladder. Other purposes of the study include looking at the safety of Gemcitabine     and Cisplatin before surgery for this type of cancer, time to recurrence of cancer, and     overall survival.      Exploratory integrative tumor sequencing:      The purpose of this part of the study is to test deoxyribonucleic acid (DNA) and ribonucleic     acid (RNA) in various types of samples (tissue and blood) to detect different types of cancer     genetic changes in upper tract urothelial cancer (UTUC) to help develop future studies in     UTUC. DNA and RNA contain key instructions for cell function and help determine the     characteristics of each individual such as hair, eye, and skin color, height, susceptibility     to diseases, and other characteristics.   "
123958|NCT01663272|"     Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is     approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated     effectiveness against pancreatic cancer in laboratory experiments, especially when given with     gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some activity     against the disease. The purpose of this study is to determine the safest and highest dose of     cabozantinib that can be given together with standard doses of gemcitabine in patients with     pancreatic cancer. This study will determine the safety and tolerability of this two drug     combination.   "
123960|NCT01663246|"     The investigators are conducting research about oral health and saliva to find out more about     the impact of radiation therapy on the oral health of patients.      In order to better understand the role of saliva in maintaining oral health in these     patients, the investigators will be collecting, storing, and analyzing the quality of saliva,     including the protein content, collected from patients following radiation therapy as well as     saliva collected from normal healthy adults.   "
123965|NCT01663181|"     At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled     for outpatient cystoscopy or urodynamic testing will be asked to participate in the study.     Patients will be called one day after the examination and will be asked about pain and their     general state of health.      The purpose of this study it to investigate pain perception in urogynecologic patients during     outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The     investigators will also investigate the difference between anticipated and actual pain     perception. The investigators will test the null hypothesis that there is no difference in     patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary     hypothesis will be that there is no difference between patients´ anticipated amount of pain     and the actually experienced pain during cystoscopy and urodynamic testing.      According to power calculation, a sample size of 52 patients per group will be needed to     detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant     difference - with 95% power and a two-sided significance level of 0.05.      Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy     and the participation in another clinical study at the same time.   "
123966|NCT01663168|"     - Background and study aims?      Some of the drugs used to treat HIV (anti-retrovirals, or ARVs) can affect the blood levels     of other drugs used to treat TB - called a drug-drug interaction. The main drug used in     second-line therapy, Aluvia (lopinavir/ritonavir), is one of the drugs that has this effect.     This is why people on second-line ARVs usually cannot use one of the main TB drugs,     rifampicin, and instead will be prescribed a slightly different drug called rifabutin,     which is less affected by these drug-drug interactions. Although blood levels of rifabutin     are not as badly affected by Aluvia as blood levels of rifampicin, rifabutin levels in the     blood are still increased a lot by taking Aluvia at the same time. This could lead to higher     levels of side-effects because there is more drug in the body. So in the past doctors have     suggested that instead of taking rifabutin every day with Aluvia, it should only be taken     three times a week, on Mondays, Wednesdays and Fridays. However, in the last 2 years, new     studies have suggested that this three times a week regimen might not be enough and that it     may not completely cure TB. So the purpose of this study is to find out whether taking     rifabutin every day with Aluvia really does lead to more side-effects, and whether taking     rifabutin three times a week with Aluvia really does lead to much lower levels of rifabutin     in the blood.      - Who can participate?      This substudy is specifically for people who are already taking anti-TB drugs in EARNEST, or     who need to start anti-TB drugs whilst they are in the EARNEST trial.      - What does the study involve?      Participants will be selected (by chance, chosen by a computer) to one of the following two     rifabutin groups:      Group 1: Rifabutin (150 mg) taken three times a week on Monday/Wednesday/Friday Group 2:     Rifabutin (150 mg) taken every day On these days, one capsule of rifabutin (150 mg) should be     taken in the morning by mouth.      Participants will be asked to attend clinic 2 and 12 weeks after entering the sub-study then     every 6 weeks until the end of their TB treatment, and then return to their usual EARNEST     follow-up schedule. This is roughly the same visit schedule for people with TB who are     usually seen more frequently than those without TB, whether or not the patients join this     sub-study. The 2 week visit is specifically so the investigators can make sure participants     are doing OK on rifabutin and to check carefully that they don't have any side-effects. At     all these visits (including the day when participants enroll into the substudy) the     investigators will take an extra 10 ml (two teaspoons) of blood to do laboratory tests for     side-effects of rifabutin, and to measure the levels of rifabutin and other ARVs in the blood     - these are called pharmacokinetic or PK studies. On the day of these visits,     participants should not take their dose of rifabutin until after this blood draw, so the     investigators can measure the lowest amount of drug likely in their blood. Instead,     participants should bring the rifabutin dose to clinic, so that they can take it straight     after the blood draw. At the visit 12 weeks after starting rifabutin, participants will need     to stay in clinic for a second blood draw of ~3 ml (half a teaspoon) around 4 hours after     they take the rifabutin dose immediately after the first blood draw. We use this second     sample to see how quickly rifabutin enters the blood. At this special visit the investigators     will make sure participants are first seen as early as possible, so they don't have to stay     any longer than necessary for the second blood draw to be taken 4 hours later. After     participants have completed their TB treatment they will stay in EARNEST until the end of the     trial (144 weeks on second-line therapy).      - What are the possible benefits and risks of participating?      If participants are allocated to Group 1 (150 mg rifabutin three times a week), there is a     risk that they may have lower levels of rifabutin in your blood and this may be less     effective at treating the TB. However, participants should have fewer side-effects. In     contrast, if participants are allocated to Group 2 (150 mg rifabutin daily), here is a risk     that they may get more side-effects, but the levels of rifabutin in the blood should be more     than high enough to have a good chance of curing the TB. Having blood taken may cause some     discomfort and/or bruising in some people. It is currently impossible to know which rifabutin     regimen would be best and participants may find in years to come that they may or may not     have received the best treatment.        -  Where is the study run from?           9 EARNEST sites in Uganda as follows: JCRC Kampala, IDI, San Raphael of St Francis          Hospital (Nsambya), JCRC Mbarara, JCRC Mbale, JCRC Kabale, JCRC Kakira, JCRC Gulu        -  When is study starting and how long is it expected to run?      Start 05/03/2012 finish on 31/01/2014      - Who is funding the study? Abbott   "
123967|NCT01663155|"     The investigators would like to see if lung cancer screening with chest x-rays,computer aided     detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more     responsive to treatment. The investigators would also like to see if early detection will     reduce the incidence of symptomatic advanced lung cancer compared to no screening in former     and current smokers with or without a family history of lung cancer who are 40-75 years old.   "
123968|NCT01663142|"     Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood.     This disease, due to its morbidity and mortality, poses a significant public health problem     in France. Apart from the involvement of bacterial factors and those involving the     permeability of the epithelial barrier, it is now well recognized that several factors are     associated with genetic predisposition in some of these patients. Among these factors, the     Nod2 mutations were first identified. Studies concerning the presence of these mutations and     the severity of disease results were sometimes conflicting. Very recently, new interesting     mutations in genes involved in autophagy were found with greater frequency in patients with     Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly     shown on large patient cohorts,the IRGM polymorphism was associated with a progressive     disease, with histological severity scores. One of the severity criteria of Crohn's disease     is the early recurrence observed in some patients after surgical resection of the injured     segment. Predictive factors for such recurrence after surgery are not known or not.   "
123969|NCT01663129|"     To determine the magnitude and rate of bone mass deficits following initiation of     glucocorticoid therapy for the treatment of pediatric leukemia, rheumatic conditions and     nephrotic syndrome, we propose a 6 year, prospective study in 12 academic, tertiary care     centres across Canada.      The investigators hypothesize that glucocorticoid-treated children with leukemia, rheumatic     conditions and nephrotic syndrome will fail to accrue bone mass at a normal rate, and that     deficits in mineral accrual will occur in a glucocorticoid dose- and duration-dependent     fashion. We also hypothesize that the fracture incidence will increase with concomitant     reductions in bone mass.   "
123970|NCT01663116|"     Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class     (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with     three treatment groups, controlled with placebo (randomization 3:1) whose target population     are patients with rheumatoid arthritis refractory to at least two biologic.   "
123971|NCT01663103|"     Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic     kidney disease (CKD); however, this increased risk is only partially explained by traditional     cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism     contributing to vascular dysfunction (i.e., large elastic artery stiffening and endothelial     dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations     characterized by chronic inflammation. However, it is currently unknown if reducing     inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients.     Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular     dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60     mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces     inflammation and oxidative stress. These studies could shift clinical practice guidelines by     establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic     hemodialysis.   "
123972|NCT01663090|"     This research study is a pilot study to evaluate a new contrast agent, ferumoxytol, for the     purpose of imaging lymph node metastases in patients with soft tissue sarcoma. This contrast     agent is an investigational drug. Investigational means that the drug is still being     studied and that research doctors are trying to find out more about it. It also means that     the FDA has not approved ferumoxytol for this use. This drug has been used to image adults     with other forms of cancer, however, it has only been used to image a small number of     pediatric patients. Ferumoxytol has never been used to image sarcoma.   "
123989|NCT01662869|"     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the     efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid,     and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor     (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction.     Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in     combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until     disease progression, unacceptable toxicity, participant or physician decision to discontinue     treatment.   "
123990|NCT01662856|"     The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols     provides a measurable benefit when compared to hemostasis achieved through conventional     surgical technique (suture) and by standard hemostatic action, such as mechanical pressure     through manual compression. This study has a Preliminary Part (I) in which all subjects are     treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized     in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.   "
124241|NCT01659528|"     The purpose of this study is to establish nomograms of penile length and width throughout the     weeks of pregnancy.   "
123973|NCT01663077|"     Approximately 30-60% of all schizophrenia patients who fail to respond to typical     antipsychotics may respond to Clozapine. Clozapine has long been considered the gold     standard within the atypical neuroleptic spectrum, backed by years of clinical experience     and research, but uncertainties remain in some aspects of this drug. One such question is the     link between dose, blood levels and patient clinical response. The Clozapine therapeutic     plasma levels range between 250 - 450 ng/mL creating difficulties in using these results in     routine clinical practice. Approximately 30% - 51% of treatment-resistant schizophrenia     patients do not fully respond to Clozapine, a poorly understood phenomenon. Factors relevant     to Clozapine-resistance include co-morbidity, drug misuse, poor adherence, inadequate     duration of treatment and inadequate dose/plasma-levels. Pharmacogenetic factors such as     different polymorphisms in involved genes may play a role. Pharmacodynamic and genetic data     appear important in determining the clinical response to Clozapine. Clozapine-treated     patients possessing different 3A4 polymorphisms, may respond differently as compared to other     patients having normal 3A4 alleles. Recently, the CYP2D6 has also been involved in this drug     metabolic pathway. Population pharmacokinetics of clozapine evaluated with the nonparametric     maximum likelihood method. This pharmacogenetic explanation/hypothesis may explain Clozapine-     resistance in schizophrenics.      The high variability in plasma levels requires a large study in order to be able to determine     correlation between clinical efficacy and plasma levels and genotyping. A preliminary study     will enable power analysis and adequate determination of sample size.   "
123974|NCT01663064|"     The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory     Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of     abdominal aortic aneurysms.   "
123975|NCT01663051|"     This prospective, non-randomized, multi-center study is intended to evaluate the Zilver®     Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.   "
123976|NCT01663038|"     The purpose of this study is to compare pharmacokinetics between fixed-dose combination and     separate combination of clopidogrel 75mg/aspirin 100mg.   "
123977|NCT01663025|"     This randomised controlled trial aims to compare the effectiveness of hand reflexology     received during office based vein surgery, under local anaesthetic on patient's reports of     pain and anxiety, compared to usual standard care.   "
123978|NCT01663012|"     High Grade Gliomas, including anaplastic astrocytomas, anaplastic oligodendrogliomas and     glioblastomas (GBM), are the most common and most aggressive primary brain tumors. Prognosis     for patients with high-grade gliomas remains poor. The estimated median survival for patients     with GBM is between 12 to 18 months. Recurrence after initial therapy with temozolomide and     radiation is nearly universal. Since May 2009, the majority of patients in the US with an     initial recurrence of high-grade glioma receive bevacizumab, a monoclonal antibody against     vascular endothelial growth factor (VEGF), which is thought to prevent angiogenesis in these     highly vascular tumors. BEV has response rates from 32-62% and has improved overall median     survival in patients with recurrent high-grade gliomas1. However, the response is short     lived, and nearly 100% of patients eventually progress despite bevacizumab. No     chemotherapeutic agent administered following progression through bevacizumab has made a     significant impact on survival. Patients progress to death within 1-5 months after resistance     develops. Therefore, patients with high-grade gliomas who have progressed through bevacizumab     represent a population in dire need of a feasible and tolerable treatment.      NKTR-102 is a topoisomerase I inhibitor polymer conjugate that was engineered by attaching     irinotecan molecules to a polyethylene glycol (PEG) polymer using a biodegradable linker.     Irinotecan released from NKTR-102 following administration is further metabolized to the     active metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38), that causes DNA damage through     inhibition of topoisomerase. The goal in designing NKTR-102 was to attenuate or eliminate     some of the limiting side effects of irinotecan while improving efficacy by modifying the     distribution of the agent within the body. The size and structure of NKTR-102 results in     marked alteration in pharmacokinetic (PK) profile for the SN38 derived from NKTR-102 compared     to that following irinotecan: the maximal plasma concentration (Cmax) is reduced 5- to     10-fold and the half-life (t1/2 ) of SN38 is increased from 2 days to approximately 50 days.     This altered profile leads to constant exposure of the tumor to the active drug. In addition,     the large NKTR-102 molecule does not freely pass out of intact vasculature, which may account     for relatively higher concentrations of the compound and the active metabolites in tumor     tissues in in vivo models, where the local vasculature may be relatively more permeable. A     145 mg/m2 dose of NKTR-102, the dose intended for use in this phase II clinical trial (and     being used in the phase III clinical program), results in approximately the same plasma     exposure to SN38 as a 350 mg/m2 dose of irinotecan, but exposure is protracted, resulting in     continuous exposure between dosing cycles and lower Cmax. NKTR-102 was therefore developed as     a new chemotherapeutic agent that may improve the clinical outcomes of patients.   "
123979|NCT01662999|"     The purpose of this study is to evaluate whether the pharmacokinetics (body     concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when     they are administered together   "
123980|NCT01662986|"     A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess     the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in     Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an     acute exacerbation (Hospital Discharge Study 2)   "
123981|NCT01662973|"     Primary biliary cirrhosis (PBC) is a slowly progressive disease that causes substantial loss     of intrahepatic bile ducts, ultimately resulting in cholestasis, advanced fibrosis,     cirrhosis, liver failure and even hepatocellular carcinoma. Histologically, the disease is     characterized by chronic portal inflammation with infiltration, destruction and loss of the     epithelial cells in the small-sized and medium-sized bile ducts. Currently, Ursodeoxycholic     acid (UDCA) in a dose of 13-15mg/kg/day is recommended as therapeutic drugs for PBC by AASLD     and is approved for this indication by the U.S. Food and Drug Administration (FDA). Treatment     with UDCA may delay disease progression and prolong survival free of liver transplantation.     However, one out of three patients does not adequately respond to UDCA therapy and many need     additional medical therapy or liver transplantation, or both. UC-MSC has been application for     the treatment of several severe autoimmune diseases, such as immune thrombocytopenia,     systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis. In this study, the     safety and efficacy of UC-MSC transplantation for PBC patients will be evaluated.   "
123982|NCT01662960|"     The purpose of the study is to determine whether an existing treatment for problems that     participants have with making movements after a stroke can be performed at home.   "
123983|NCT01662947|"     The clinical protocol of the clinical testing of this device:        1. Objective of the test: To verify the efficiency of device.        2. Test methods and procedures: Clinical test in two positions: Seated and Supine.        3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and          range: 0-300 mmHg.        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.        6. Statistical methodology used: Description of statistical methods.        7. Result: Meet the requirements of SP10.   "
123984|NCT01662934|"     The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine     could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.   "
123985|NCT01662921|"     We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting     insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with     gestational diabetes mellitus.   "
123986|NCT01662908|"     Assess the relative change in thrombus volume as determined by two assessments (Baseline and     Day 14-21) with magnetic resonance venography (MRV) in subjects with deep-vein thrombosis     (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW)     heparin/warfarin regimen.   "
123987|NCT01662895|"     The main purpose of this study is to determine whether treatment with deferoxamine mesylate     is of sufficient promise to improve outcome before pursuing a larger clinical trial to     examine its effectiveness as a treatment for brain hemorrhage.   "
123988|NCT01662882|"     Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing     Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or     Mild cognitive impairment (MCI).   "
123991|NCT01662843|"     The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right     ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial     Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis.     Primary outcomes measured are the magnitude of change in differential diagnoses.   "
125255|NCT01645800|"     The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks     lysozyme administration in patients with COPD.   "
123994|NCT01662804|"     The purpose of this study is to find out if humanized 3F8 (Hu3F8) when combined with     interleukin-2 (rIL2) is safe for treating neuroblastoma and other cancers. A phase 1 study     means the investigators are trying to find out what side effects happen when higher and     higher doses of a drug are used.      The investigators want to find out what effects, good and/or bad, Hu3F8 combined with rIL2     has on cancer. The amount of Hu3F8 that patients gets will depend on when they start     treatment on this study. The amount of rIL2 will be the same for all patients. The     investigators also want to find out more about how Hu3F8 works and how effective it is in     attacking the disease when combined with rIL2.   "
123995|NCT01662791|"     The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in     patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was     that SBBO is an important contributor to the development of weight loss in individuals with     PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in     patients with PD and 2) determine the response to its treatment with a poorly absorbed     antibiotic. The investigators performed a prospective, observational case-control study (Part     1) with an open-label therapeutic component (Part 2). Cases were defined as those PD patients     who experienced significant weight loss while Controls were defined as those PD patients who     did not experience significant weight loss.   "
123996|NCT01662778|"     The objective here is to determine that the efficiency of inhaled drug delivery can be     improved by using a fine mist cloud of drug particles (as opposed to a coarse mist cloud of     drug particles). This information will be valuable in designing new inhalers in order to     improve their beneficial effects and reduce their side effects, by using the least possible     drug dose to achieve a good patient response.   "
123997|NCT01662765|"     The aim of the study was to compare the results of conservative and surgical treatment, to     create an algorithm for the management of the disease, and gain more information about the     etiology, pathogenesis, and course of the disease. The investigators hypothesise that     surgical treatment of UPS will be better than conservative management in terms of recurrence     rate, healing time, patient comfort and satisfaction, and cost effectiveness.   "
123998|NCT01662752|"     The main objective of this study is to determine whether the first (sentinel) lymph nodes in     the drainage pathway of colonic tumour can be detected at the time of surgery using a new     technique. The detection method is to inject a fluorescent dye (indocyanine green) adjacent     to the tumour. The dye will then be seen as it fluoresces in the light form the near infrared     spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An endoscope is     placed in the colon (colonoscopy) during surgery and the tracer fluorescent agent is injected     around the tumour. The mesentery in which the lymph nodes draining the tumour are located     will then be examined by laparoscopy as it is expected that fluorescence will be identified     within approximately 5 minutes of the injection. The first lymph node or nodes that take up     the fluorescent dye will then be marked by placing a clip or a stitch by them. After the     surgery has been completed and colon removed all lymph nodes can be examined microscopically     by the pathologist, paying a particular attention to whether any tumour cells are present in     the sentinel lymph nodes and whether the presence or the absence of tumour cells in that node     accurately reflects the tumour status of the rest of the specimen.      If this pilot demonstrates that sentinel lymph nodes can be reliably detected, we have     developed a technique which allows us to remove a small area (less than 5 cm) of the colon.     Using this procedure should decrease complications following traditional surgery. We however     also need a method that allows accurate assessment of the lymph nodes draining the tumour.     This pilot trial will examine our ability to detect such 'sentinel' lymph nodes so that we     can use their status (positive for cancer cells or negative) to determine whether a smaller     operation such as full thickness localised excision is adequate treatment for the patient and     that they can avoid a larger operation.   "
123999|NCT01662739|"     Gastric cancer remains one of the leading causes of cancer-related deaths worldwide. There is     difference between different countries in the world in the incidence and outcome. Also Italy     on its inside shows a variability between regions and Lombardy hold the most incidence and     mortality Italian rate, with the province of Cremona as one of the leading area with its     gastric cancer mortality rate. (http://www.aslcremona.it/html/atlante/introduzione.htm).     Tumor specialized registry can be viewed as one of the main strategies for studying and     monitoring the impact of an important cancer diagnosis. In addition the information obtained     from it can be translated into preventive measures and health surveillance that might lead to     a better control of this tumor in a province with a so high mortality rate. Project purpose     is to define the incidence of gastric cancer in the province of Cremona and the correlation     with environmental, familiar, genetic and social factors; to adopt prevention strategies to     reduce the impact of the disease and to create a gastric cancer bio-bank, including blood and     tissue samples, for collaborative research projects regarding molecular and cellular aspects     of gastric cancer.   "
124000|NCT01662726|"     This study is investigating the effects of a new hormone treatment for breast cancer called     Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to     grow therefore are likely to respond to hormone therapy. Irosustat blocks a different pathway     of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the body. As less     oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether.      IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast     cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on     breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a     radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner     which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of     scan can show how body tissues are working, as well as what they look like. FLT-PET scans     will be performed before and following treatment with Irosustat. As cancer cells grow faster     than the normal cells around them, they will take up more of the radioactive substance, and     so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer     will take up less of the tracer.      Blood samples will be taken at regular intervals to assess what the new drug does to the body     and the safety and tolerability of Irosustat will be assessed. The study incorporates     translation aspects/endpoints which are based on the collection of tumour biopsies before and     after treatment with Irosustat although the later biopsy is not mandatory.   "
124021|NCT01661400|"     The purpose of this research study is to determine whether taking either of two low dose     drugs that would prevent new blood vessels from growing after stem cell transplant is     feasible, and what the side effects of taking each of these drugs after autologous transplant     might be. The reason the investigators are looking at these drugs is because one of the     things that allows tumors to grow quickly is their ability to stimulate the growth of new     blood vessels. By suppressing the growth of new blood vessels after stem cell transplant, the     investigators hope to prevent the tumors from coming back or continuing to grow.   "
124002|NCT01662700|"     In Thailand, the proportion of P.vivax infection has now been increasing and is equal to     Plasmodium falciparum since 1998. The incidence of P.vivax has recently been reported as 20     per 1000 population per year. Unlike Plasmodium falciparum, P.vivax infection rarely develops     into complicated malaria and death is unusual. However, P.vivax has a dormant stage (the     hypnozoite) that persists in the human liver and may cause relapse weeks, months, or even     years later. Therefore, P.vivax infection is considered to have greater impact on morbidity     than mortality, resulting in significant social and economic burden. Moreover, it is very     difficult to control P.vivax transmission, because gametocytes appear almost simultaneously     with schizonts.      Radical treatment of the infection, therefore, normally consists of a blood schizontocidal     course of chloroquine and a course primaquine for the elimination of the hypnozoites as     anti-relapse therapy. In Thailand, chloroquine and primaquine have remained the mainstay     chemotherapeutics for the treatment of P.vivax for more than 60 years and resistance has not     yet been reported . The relapse rates at day 28 are about 50% without primaquine therapy and     about 20% with standard primaquine therapy. Relapse has not been observed among patients     receiving high dose primaquine therapy (30 mg daily for 14 days).      Since January 2007, the evidence of reduced susceptibility of Plasmodium falciparum to     artemisinins in Western Cambodia at Thai-Cambodia border was first presented and confirmed in     a subsequent detailed pharmacokinetic-pharmacodynamic study. Nevertheless, a trend of gradual     decline of in vitro sensitivity to chloroquine has been documented in some areas of the     country, particularly Thai-Myanmar border. There has been no clinical-parasitological     evidence of chloroquine resistant P.vivax in Thai-Cambodia border, Thailand.      The objectives of the present study are to assess in vivo efficacy of first line regimen of     chloroquine given with primaquine, and in vitro susceptibility of P.vivax isolates in areas     along Thai-Cambodia border, Thailand.   "
124003|NCT01662687|"     Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to     demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared     with the intravenous and oral Granisetron in the prevention of CINV associated with     moderately emetogenic Chemotherapy.      Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4     days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible     patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2     days prior to ME chemotherapy).        -  Sancuso patch        -  Kytril inj.+Kytril tab.      The patch will be applied 2days (48-24h) prior to first daily dose of the moderately     emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed     daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be     collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until     14 days after the final dose of IP. Serious adverse events will be followed-up until they are     resolved, stable or until the patient is lost to follow-up.   "
124004|NCT01662674|"     This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of     the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison     to each component administered in healthy male volunteers.   "
124005|NCT01662661|"     The purpose of this study is to assess the relative bioavailability (the degree to which the     study medication becomes available in the blood circulation) of JNJ-47910382, given as an     uncoated tablet and as a suspension, after a single oral dose of 200 mg in healthy adult     participants under fed conditions.   "
124006|NCT01662648|"     The purpose of this study is to explore the efficacy of flexibly dosed paliperidone     extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms     of emotional instability, detachment from reality, often with delusions and hallucinations,     and withdrawal into the self) who were previously unsuccessfully treated with other oral     antipsychotics.   "
124007|NCT01662635|"     Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is     critically important to select those patients who are more likely to have the ALK mutation.     Clinical characteristics of patients with mutations in the target gene should also be known,     so that the incidence of a given target mutation is established in a specific population.     There is not incidence known in Mexican population, but it is believed it is greater.   "
124008|NCT01662622|"     Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to     investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC     of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)     in middle aged subjects.   "
124009|NCT01662609|"     The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early     stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the     development of pancreatic cancer. Endoscopic refers to the use of an instrument called an     endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound     refers to an imaging technique that uses sound waves to produce pictures. EUS in this     research study is a method of combining endoscopy and ultrasound imaging to obtain high     quality images of the pancreas.   "
124010|NCT01662596|"     The purpose of the study is to estimate the rate of risk factors for appearance of disease or     fetal malformations in a population who turn to hospital Hillel Yaffe and examine whether     there is a difference in the rate of early testing for diseases or birth defects in the     fetus.      Understanding the population and its risk factors, will allow specific reference to these     risk factors to lowering them to eventually reduce the rate of congenital malformations in     this population.   "
124011|NCT01662583|"     Influenza remains a potentially significant and largely preventable source of morbidity and     mortality, yet vaccine coverage is low. Young children are at particular risk for     underimmunization because they may need to receive 2 doses in a current season. Even among     those young children that initiate vaccination, only 40% receive the important second dose,     yet one dose does not confer adequate protection. Low-income, urban children may be at     particular risk of not receiving two doses. While traditional mail and phone immunization     reminders notifying families that a vaccine is due have had limited efficacy in low-income,     urban populations, we have demonstrated the success of using text messages. Comparing the     effectiveness of different forms of reminders on receipt of this critical second dose of     influenza vaccine has not been studied. Besides failure to remember to return for subsequent     doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health     literacy regarding influenza vaccination, particularly associated with understanding the need     for a second dose since not all children require it. Text messaging offers the ability to     combine health literacy promoting information and reminders in a scalable, efficient manner     for populations at high risk for underimmunization, limited health literacy, and influenza     spread. Therefore, the purpose of this study is to determine whether the provision of     interactive vaccine health literacy-promoting information in text message vaccine reminders     improves receipt and timeliness of the second dose of influenza vaccine within a season for     underserved children in need of two doses.   "
124012|NCT01662570|"     The rise in childhood overweightness and concomitant increase in chronic disease risk     warrants exploration into the effectiveness of interventions targeting the eating and     activity habits of overweight youth. This research study developed and tested a Beverage     Choice and Lifestyle Modification (BCLM) intervention for 4 to 8 year old children who are     at-risk for being overweight or are overweight and who consume large amounts of sugar     sweetened beverages and juice. The overall study objectives were to test the acceptability     and effectiveness of the BCLM intervention for improving the weight status, energy (kcal)     intake, beverage selections and beverage preferences of children in targeted age and BMI     group. The investigators hypothesized that those children randomized to the BCLM group will     show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and     energy intake than those assigned to our Nutrition Education (NE) group.   "
124013|NCT01662557|"     Childhood overweight continues to increase at an alarming rate and the need exists to find     effective, accessible intervention strategies to prevent and treat children who are at risk     for being overweight or are already overweight. The primary care setting provides an     attractive option for families wishing to receive treatment, yet little is known about the     feasibility, acceptance or efficacy of this intervention setting. The purpose of this study     was to test two different primary care treatments that were intended to increase fruit and     vegetable intake, increase physical activity, and reduce sedentary activity in children ages     4-8, who are overweight or at risk for becoming overweight. Both treatments involved the     child and a parent/caregiver and both were conducted over a four month period. The     parent/child dyads were selected from the pool of families who receive their primary care     within the Geisinger Medical Center geographic area and who have been identified by their     pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for     age). One group received weekly mailings which focused on healthy eating, promotion of fruit     and vegetable intake and physical activity, and methods to reduce TV viewing time. The second     group received a group-based intervention at one of the Geisinger Pediatric Clinic sites     using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV     viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid     profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as     treatment satisfaction and acceptance. The investigators hypothesized that children who     receive Family Behavior Modification (FBM) in the primary care setting will show greater     reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference,     and that children receiving FBM will show greater improvements in dietary intake, increased     physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.   "
124014|NCT01662544|"     Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and     children. Multiple supportive therapies have been tried in infants with bronchiolitis     including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date     supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in     infants with bronchiolitis, with hypertonic saline showing a borderline statistically     significant improvement. This prospective, randomized study will compare CSS and PEWS scores     on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen     via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants     with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have     improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and     ultimately decreased lengths of admissions when compared to patients treated with nasal     cannula oxygen therapy with/without bronchodilator therapy.      Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases respiratory     distress as measured by pediatric CSS and PEWS when compared with routine nasal cannula     oxygen delivery in infants with bronchiolitis.   "
124015|NCT01662531|"     This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control     and prevention of bleeding episodes in children who have previously received factor     replacement therapy for hemophilia B.   "
124016|NCT01662518|"     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone     (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.   "
124017|NCT01662505|"     To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese     patients with AML   "
124018|NCT01662492|"     To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline)     as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.   "
124019|NCT01661426|"     The traditional weight loss diet recommended by health professionals has been a low-fat,     high-carbohydrate, calorie restricted diet. This recommendation has been challenged by a     number of alternative dietary strategies, particularly low-carbohydrate diets. In several     recent weight loss studies insulin resistant adults had more success with low- vs.     high-carbohydrate diets, in contrast to insulin sensitive adults who had either more success     or comparable success with the low-fat diets. The investigators enrolled 61 people with a     wide range of insulin sensitivity/resistance. After determining their insulin resistance     status, the investigators will split them in the middle and randomly assign them to one of     four groups for six months: (1) Low-Carbohydrate/Insulin Resistant (LC/IR); (2)     Low-Carbohydrate/Insulin Sensitive (LC/IS); (3) Low-Fat/Insulin Resistant (LF/IR); and (4)     Low-Fat/Insulin Sensitive (LF/IS) (15 people/group). After 6 months the participants will     switch diet for the following 6 months, i.e. those randomized to the Low-Carbohydrate diet     will switch to the Low-Fat diet and vice-versa. The primary outcome of this study is to     determine whether weight loss success can be increased if one follows the dietary approach     appropriately matched to their insulin resistance status. Secondary outcomes include fasting     insulin, glucose, lipids, and fatty acid composition.   "
124020|NCT01661413|"     Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy.     Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during     treatment reported by paediatric cancer survivors. Complete prevention of both nausea and     vomiting is the goal of anti-vomiting and nausea medications. It is important to understand     whether or not certain chemotherapeutic treatments are more or less likely to cause these     symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal     methotrexate is an important part of chemotherapy for the prevention and treatment of central     nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The     likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and     vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal     methotrexate will cause nausea and vomiting will therefore be important to optimize treatment     for these side-effects of chemotherapy. The primary aim of this prospective study is to     evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric     cancer patients.   "
125437|NCT01643213|"     The purpose of this study is to evaluate patient preference of the Boston Scientific     Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the     Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.   "
124023|NCT01661374|"     In this study the investigators will collect mucus from mechanical ventilated patients and     patients with COPD to study the effect of temperature and humidity, on the biophysical     properties of the airway mucus. It is hypothesised that changes in inspired gas temperature     and humidity (over time) may affect the biophysical properties of the airway mucus and reduce     the airway's ability to clear mucus, resulting in deleterious clinical affects.   "
124024|NCT01661361|"     Recently, it was reported that when vancomycin levels are determined after port sampling,     levels can be falsely increased potentially leading to wrong dose adjustments.      The investigators conducted an in vitro experiment using several central venous port devices,     in which different flushing techniques were evaluated yielding residual vancomycin levels of     less than 0.5 mg/L.      In this study, the investigators want to evaluate this flushing technique in vivo in 15     patients admitted with catheter-related infection and treated with systemic vancomycin and     vancomycin antibiotic lock.      The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained     via port sampling.   "
124025|NCT01662466|"     The purpose of this study is to determine the effect of treatment with trans-dermal     testosterone cream compared to placebo on measures of ovarian reserve, oocyte and embryo     quality, and pregnancy rates among women with evidence of diminished ovarian reserve that     have persistently low serum testosterone and free testosterone after completing six previous     weeks of DHEA supplementation.   "
124026|NCT01662453|"     The main purpose of this study is to develop a North American registry for SUDEP cases;     requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to     contact the study team. The family members who decide to participate in the study will be     asked to complete a brief telephone interview about their loved one's epilepsy and seizure     history and the circumstances of his or her death. If the death has occurred within the past     24 hours, and the family is willing to consider donating tissue to the study, the subject     will be transferred to the Autism Tissue Program, and the remainder of the phone interview     will be conducted at a later time.      In addition to the phone interview, the family will be asked to provide access to the     deceased's medical records. Any costs involved in obtaining medical records will be covered     by the study, and all medical information will remain completely confidential.   "
124027|NCT01662440|"     Establish non-inferiority of the immune response and evaluate the safety and tolerability of     Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to     either of 2 schedules for preexposure prophylaxis.   "
124028|NCT01662427|"     To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in     Parkinson's disease patients and caregivers.   "
124029|NCT01662414|"     This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo     (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.      The principal objective is to evaluate the changes in biomarkers of oxidative stress     and,plasma amino acids, as well as improvement of clinical symptoms and brain function   "
124030|NCT01662401|"     After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in     the postoperative period. As a routine part of the procedure, surgeons inject local     anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most     children will still require additional pain medications after surgery. The purpose of the     study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal     nerve) will give better pain relief, decreasing pain medication requirements and increasing     comfort during the postoperative period.   "
124031|NCT01662388|"     Several techniques have been advocated to get good contacts in dental composite restorations     including interdental separation ring. The investigators study focuses on using separation     ring with circumferential matrix band instead of a sectional band. Moreover, the     investigators have attempted to study proximal tightness and proximal contours of composite     restoration as separate variables   "
124032|NCT01662375|"     The Maastricht III procedure consists of performing organ donation in patients in whom     cardiac arrest is consecutive to a decision to withdraw life support.This MIII procedure is     not applied in France, in contrast with other industrialized countries.The proposed study is     designed to evaluate the feasibility of adapting the MIII procedure in France by conducting a     single-centre, prospective study. Within the population of patients admitted to the Nantes     University Hospital Medical Intensive Care Unit for whom a clinical team meeting decides to     withdraw life support, the investigators want to determine the delay elapsed between the life     support withdrawing and the onset of spontaneous cardiac arrest, that is without any     intentional procedure susceptible of precipitate the death onset. The cardiovascular state     observed during this period and its duration determine the viability of the organs harvested.     The invetigators also want to determine the incidence of refusal of organ donation that would     be formulated by the family and/or loved ones if they had been asked to consent to an MIII     procedure at the time of announcement of the clinical team's decision to withdraw life     support.Anonymous data concerning the patient will be collected by using a predefined grid,     completed partly by the medical team in charge of the patient and partly by a CRA from data     in the patient's medical file.The study with families and/or loved ones will be conducted in     the context of the CHU de NANTES Clinical Ethics Unit and according to this unit's     methodology. The main working tool used by the Clinical Ethics Unit consists of interviews     between its members and the various parties participating in elaboration of a decision (in     this case, the virtual possibility of organ donation according to the MIII procedure).The     purpose of this interview is to stimulate reflection on issues not previously considered, by     introducing new elements and by using, as a tool, the principles of biomedical ethics     developed by Beauchamps and Childress. This study should be able to determine which types of     patients could be concerned by the Maastricht III procedure. The expected results should help     to define the quantitative impact and feasibility of this procedure on organ donation and     could be used to subsequently propose a larger-scale multicenter prospective study.   "
124242|NCT01659515|"     The primary purpose of this protocol is to make arbekacin available for treatment of patients     with infections caused by multidrug-resistant organisms when treatment with other antibiotics     cannot be used due to unavailability, intolerance, contraindications, or treatment     non-response.   "
124035|NCT01662336|"     The study will assess the effectiveness of KASA (Kaletra Patient Support Program) on     improving or maintaining treatment adherence in HIV positive patients that have been     initiated on treatment with Kaletra®. This will be a purely observational study conducted on     patients that will be on treatment with Kaletra®. All treatments will be as per routine care     including the use of KASA which will be determined exclusively by the physician and the     patient without consideration of the study.      The efficacy of disease management programs as assessed in randomized clinical trials is not     representative of real - life effectiveness observed under routine clinical practice. In real     - life settings the utilization of and compliance with disease management programs by     physicians and patients is not uniform. Therefore assessment of their true effectiveness is     ideally conducted under a pure observational setting without any interference from the     investigators with respect to making the programs available to patients and enforcing their     adherence to them.   "
124038|NCT01662297|"     This is a pilot comparative effectiveness study designed to determine whether trazodone is as     effective as quetiapine for treatment of insomnia in veterans with a history of addiction and     mental health issues. The study will have two concurrent phases (parts); first an     acceptability determination phase, to determine whether and why (or why not) veterans already     taking quetiapine are willing to try an alternative to quetiapine for sleep; and second, a     randomized trial phase which will test whether staying on quetiapine has any advantage over     switching to trazodone. The purpose of the first phase will be a) to document the proportions     of patients and physicians who are willing to agree to such a switch, b) to characterize     sociodemographic and clinical characteristics of potentially eligible subjects associated     with a willingness to switch from quetiapine to trazodone and c) to record the reasons given     why patients and their prescribers are (or are not) willing to accept a switch from     quetiapine to trazodone. It will also function to provide some educational background to     patients and a reminder to providers about the potential severe side-effects of quetiapine,     and will thus facilitate clinical informed consent for the clinical trial phase of the study.     Completion of the first part of the study will also serve as the screening component for part     II. Part II includes, first, obtaining written informed consent from eligible subjects, and     then randomly assigning them to continue quetiapine or to be switched to trazodone in     open-label real world fashion for the duration of 4 weeks, followed by another four weeks     of open, non-randomized follow- up. The purpose of the second part of the study is to     determine if trazodone is an adequate substitute for quetiapine, primarily in terms of     treating insomnia. The investigators hypothesize that trazodone will not be inferior to     quetiapine in maintaining good quality of sleep measured by sleep scales (i.e., scores will     not significantly worsen once switched). This study is open to Veterans in the VA system     only. Eligible subjects must have a history of dual diagnosis (i.e., a history of addiction     and mental illness).   "
124039|NCT01662284|"     The purpose of this study is to assess the use of investigational compound 124I-NM404 for     accurate detection and characterization of a wide variety of solid primary and metastatic     malignancies anywhere in the body.   "
124040|NCT01662271|"     The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life,     psychosocial situation, and health of the affected youth. However, as few of these     adolescents seek medical care, little is known about the longitudinal course of adolescent     extreme obesity.      In this study, the investigators aim to provide structured care for adolescents with obesity     and extreme obesity over a prolonged period of time, and to gain information on the course of     obesity and the success of different treatment options. The study is a subproject of the     Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects     of structured care, short: Youth with Extreme obesity Study (YES), which aims at improving     the medical care and social support structures for youth with obesity and extreme obesity in     Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years     (initially up to 21 years) are eligible to participate. Participants will have a physical     check-up every 12 months (initially every 6 months), complete questionnaires on their health,     socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to     assess comorbidities. Participants are offered support and guidance for social and vocational     integration. The study will evaluate and inform treatment and support options for adolescents     with extreme obesity.   "
124041|NCT01662258|"     This is a prospective interventional study to assess laboratory testing which will identify     the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent     selection for patients with community acquired-pneumonia (CAP).      Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with     respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted     narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to     Empiric therapy in patients with viral pneumonia   "
124042|NCT01662232|"     Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired     endothelial function (assessed as flow-mediated dilation) represents an early marker for     later cardiovascular events. Epidemiological and experimental studies suggest that     consumption of tea is associated with lower progression of atherosclerosis and reduced     cardiovascular mortality.      Tea contains high amounts of polyphenols with important biological activities. The green tea     catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound     in vitro. However, little is known about its contribution to beneficial effects of tea in     vivo.      In this crossover study the impact of a single dose of EGCG applied in different forms (green     tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in     healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to     appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in     cardiovascular protective effects of green tea in vivo. The outcomes will provide insights     about the role of EGCG in different application forms to improvements of endothelial function     in humans.   "
124184|NCT01660490|"     An expert panel of surgeons agreed that there is not any established, standardized approach     to the teaching of intraoperative imaging and that there may be practice gaps in decision     making and the use of imaging among trauma surgeons.      The panel is set to initiate a consensus-based evaluation process to develop a list of     criteria for assessing images and would like to validate these criteria for differentiating     good quality versus poor quality images in term of reliability and accuracy.   "
124043|NCT01662219|"     Pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted     as moderate in severity, often needing oral opioid analgesics. In addition, these patients     are more prone for postoperative respiratory complication due to airway edema secondary to     surgical retraction or wound hematoma. Opioid analgesics provide good pain control but     postoperative nausea and vomiting and respiratory depression are undesirable in these     patients who are at risk for postoperative wound hematoma and airway edema The use of     multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after     ambulatory procedures at most surgery centers throughout the world . The purpose of this     study is to determine whether superficial cervical plexus block will improve the     postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire     (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.   "
124044|NCT01662206|"     The purpose of this study is to determine whether healthy older adults, aged 65 to 80 years,     consuming a probiotic each day for three weeks will have improved immune strength and     digestive health. It is hypothesized that older adults consuming the probiotics will see a     shift in their microbiota towards the healthy bacteria resulting in a greater proportion of     immune cells, decreased inflammation, and better digestive health.   "
124055|NCT01662063|"     This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in     participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414)     or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants     will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96     weeks.   "
124045|NCT01662193|"     The epidemic of type 2 diabetes is an enormous public health problem in all parts of the     world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a     role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory     biomarkers are known as a new risk factor for diabetes. There is accumulating evidence     suggesting that altered vitamin D and calcium homeostasis affect the development of type 2     diabetes, but it is still unclear whether that effects are through reducing the level of     adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate     the effects of vitamin D and calcium supplementations alone and in combination on     inflammatory biomarkers and adypocytokines in type 2 diabetic patients.      This study is a single masked, controlled randomized trial with period of 8 weeks. 120     diabetic patients who met the inclusion criteria will enroll in this study. Subjects will     randomly assign in to four groups. Randomization will be achieved by permuted blocks with     stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive     50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium     carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus     100 of mg calcium carbonate per day and group four will receive calcium and vitamin D     placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin,     HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high     sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the     baseline and at the end of intervention. Systolic and diastolic blood pressure and     anthropometric measurements (height, weight, hip and waist circumferences) will be measured     at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity     records will be taken at 2,4 and 6 week of intervention to make sure that all subjects     maintain their usual diet and physical activity during intervention.   "
124046|NCT01662180|"     This large prospective multi-center cohort study aims to identify patient's characteristics     that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU     recombinant FSH.   "
124047|NCT01662167|"     The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.   "
124048|NCT01662154|"     Anesthetizing nerves in the extremities is an effective way to freeze an area in preparation     for surgery. The doctor injects local anesthetic in an appropriate area, interrupting signals     from nerves in that area that control movement and sensation. Depending on how much     anesthetic is injected, the doctor can impair both movement and sensation or sensation alone.     Currently, there are a few methods used to determine how much sensation a patient has in an     area, such as testing the patient's response to a pinprick or cold sensation on the skin.     Unfortunately, these methods are subjective and don't always give an accurate measurement of     how extensive the block is. For this reason, a more accurate and objective method of     assessing nerve blocks is needed. We wish to perform a study to test two nerve stimulation     devices to compare their ability to give adequate measurements of nerve activity before and     after local anesthesia. If we find that a common nerve stimulator can consistently give     accurate readings of nerve activity, anesthesiologists may be able to use this device to     determine how well a nerve block is working and adjust the patient's anesthesia accordingly.   "
124049|NCT01662141|"     The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper     management of severely hemodynamic compromised patients. A new ultrasound dilution method     (COstatus) for cardiac output measurement has been developed.   "
124050|NCT01662128|"     Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with     more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy     of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental     group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21     days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And     the control group will not receive any adjuvant therapy.Finally the investigators will assess     the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using     medications.   "
124051|NCT01662115|"     The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative     period influences surgical outcome in patients undergoing colorectal surgery.   "
124052|NCT01662102|"     The purpose of this study is to evaluate the effect of consolidation treatment Zevalin®     versus maintenance treatment with Rituxan® on progression-free survival (PFS) following     response induction with chemotherapy plus rituximab in previously untreated patients with     follicular lymphoma.   "
124053|NCT01662089|"     Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient.     But the type of patient, efficacy, and side effect in detail of zinc supplement are not well     characterized. The purpose of this study is to determine efficacy and side effect of chelated     zinc in FPHL who using 5%minoxidil solution.   "
124064|NCT01661946|"     Currently, two similar medications are available for injection into the eye to treat a     variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab     (Avastin). They both have a similar mechanism of action and work equally well, however only     ranibizumab was designed for use in the eye. It is significantly more expensive per injection     than bevacizumab (by a factor of roughly 40x).      In published studies trends have been noted towards an increased rate of systemic side     effects such as heart attacks and strokes. This is presumably due to absorption of the     drug(s) from the eye into the bloodstream, however this has never been shown before. The     purpose of the investigators study was to compare the bloodstream levels of bevacizumab and     ranibizumab at various time points after injection into the eye. This required the creation     of a sophisticated assay to measure blood levels of the drugs.   "
124054|NCT01662076|"     Cancer-related fatigue has been described as a subjective feeling of physical, emotional,     and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome     symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the     trajectory of their disease. Treatment interventions for cancer-related fatigue have been     largely unsuccessful. Homeopathy involves treatment of patients with diluted natural     substances aimed at stimulating the body's healing system. In the efficacy trial literature,     individualized homeopathy shows the most promise over other forms of homeopathic     intervention. Individualized homeopathic treatment involves a unique yet established method     of case taking. During the consultation, the homeopath asks a series of broad questions to     elicit subjective symptoms related to the patient's disease, their medical history, as well     as particular characteristics (physical or psychological) related to the individual. This     study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat     their fatigue. This study hypothesizes that homeopathic treatment will effectively treat     fatigue.   "
124228|NCT01659879|"     The aim of this study is to determine whether multimedia based health information presented     in a pediatric acute ward to parents of children with breathing difficulties due to lower     respiratory tract infections, is more effective than verbal information to reduce the     parent's anxiety and to increase satisfaction with nursing care and health information.   "
124056|NCT01662050|"     A phase 2 study of standard R‐BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara‐c 800     mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several     regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma     (MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine +     ara‐c combination had very good clinical activity, but a quite relevant hematological     toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano     Conference, Poster 236).      Objectives:      The primary objective is to determine the activity (complete remission rate according to     Cheson 2007 criteria) and safety of age‐adjusted Rituximab‐Bendamustine‐Cytarabine (RBAC500)     regimen at the end of treatment in older untreated patients with MCL.      The secondary objectives are to determine:        -  The rate of molecular response (characterized by labs of the FIL)        -  The progression‐free survival (PFS)        -  The overall survival (OS)        -  The duration of responses (DOR)        -  The rate of patients that complete the expected treatment schedule (6 courses)        -  The rate of patients that are subject to dose reductions or delays   "
124057|NCT01662037|"     Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to     investigate if Bosentan therapy can modify the outcome of children with functional single     ventricle.   "
124058|NCT01662024|"     Gastric restriction is an important principle of both roux-en-Y gastric bypass and     laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing     System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric     size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of     this system has the potential to reduce the complications associated with current surgical     approaches while effecting the desired gastric restriction. The primary objective is to     collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery,     Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive     procedures.   "
124059|NCT01662011|"     Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that     delivers ventilatory assist in proportion to neural effort. It was a controlled randomized     single-center prospective study in order to explore the efficacy of this new mode of     mechanical ventilation after corrective open-heart surgery for congenital heart disease.   "
124060|NCT01661998|"     The purpose of this study is to evaluate the relationship of A) The distal fusion level B)     The total length of fusion and the post-operative range of motion in the unfused vertebral     segments below the fusion in patients with Adolescent Idiopathic Scoliosis.   "
124061|NCT01661985|"     The purpose of this on-going study is to study the number of days after antibiotic treatment     has commenced (due to infection caused by the sexually transmitted bacteria Chlamydia     trachomatis (CT) and Mycoplasma genitalium(Mg)) it takes to be cured i.e to get a negative     test result. The specimens are analyzed on first-catch-urine (men) or patient's self-obtained     vaginal sample with quantitive nucleic acid amplification test(NAAT). A secondary aim is to     detect macrolide resistant Mg-strains and study whether there are any emerging macrolide     resistant Mg-strains after treatment with azithromycin. A third aim is to study whether the     participating subjects are adherent to the study protocol meaning 12 samples taken during a     period of four weeks.   "
124062|NCT01661972|"     The Primary Phase I objectives are to determine the recommended phase II dose for the     capecitabine and aflibercept doublet combination; and to describe any dose limiting and     non-dose limiting toxicities. The Phase II Primary objective is to determine progression free     survival associated with this regimen. The Phase II secondary objectives are to determine     response rate associated with this regimen; to determine overall survival associated with     this regimen; and to explore any correlation of clinical outcome with baseline and on     treatment changes in blood-based angiogenesis biomarkers.      This open-label, non-randomized phase I/II trial is designed to assess the safety,     tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic     colorectal cancer.   "
124063|NCT01661959|"     The purpose of this study is to analyze the long-term outcomes of surgical treatment of     idiopathic scoliosis of all curve patterns treated by either anterior or posterior     procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic     scoliosis.   "
124065|NCT01661933|"     We have established that the hookworm Necator americanus (Na) dramatically alters the local     and systemic immune landscape of the infected human host. Consistent with the principle of     desensitisation, diet managed celiac disease subjects previously infected by us with Na will     be invited to receive small incremental doses of gluten as pasta (3-25 mm straw of spaghetti)     over 16 weeks. Each participant will then be carefully re-assessed to determine if it is     appropriate to undertake a 12-week gluten challenge.   "
124199|NCT01660295|"     This study will assess the pharmacokinetics in subjects with severe renal insufficiency and     healthy subjects.   "
124243|NCT01659502|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118     alone or in combination with pancreatic cancer chemotherapy.   "
124066|NCT01661920|"     The duration of antibiotic treatment in community-acquired pneumonia (CAP) lasts about 9-10     days, and is determined empirically. The last North American guideline for CAP recommends     using clinical stability criteria as a reference to establish the duration of antibiotic     treatment, which would result in about 5 days of antibiotic use for the majority of pneumonia     cases. In order to validate this proposal we propose to carry out a randomized multicenter     double-blind (until the 5th day) clinical trial with adult CAP patients admitted to 4     hospitals in Euskadi. A control group (with routine treatment) will be compared with an     intervention group (antibiotic treatment for at least 5 days, which will be interrupted if     temperature is =< 37,8ºC for at least 48 hours and no more than one sign of clinical     instability is assessed), with regards to: mortality at 15 days, clinical recovery by days 10     and 30, clinical improvement after days 5 and 10 as evaluated by PRO scales, duration of     antibiotic treatment. A non-inferiority dichotomous sequential analysis will be performed     (for mortality after 15 days, clinical recovery by day 10 and in follow-up at 30 days,     clinical improvement after days 5 and 10, with PRO scales) as well as a superiority analysis     for the duration of the antibiotic treatment. A total of 1100 patients will be recruited,     following their signed consent, during the inclusion period (18 months). Stability criteria     will be measured daily. The rest of the variables will be measured at admission and by     telephone on days 10 and 30.   "
124067|NCT01661907|"     Postoperative delirium is a common complication in critically ill patients after surgery. Its     occurrence is associated with worse outcomes of the patients. The pathophysiology of delirium     remains poorly understood. A universal phenomenon is that delirium was frequently identified     in elderly patients after major complicated surgery, but was rarely noted after minor     ambulatory surgery (such as cataract surgery). This indicated that stress response produced     by surgery might have an important role in the pathogenesis of delirium. It has been reported     that, when compared with general anesthesia and postoperative intravenous analgesia,     neuraxial anesthesia and analgesia reduced the occurrence of postoperative complications and     mortality in high risk patients. Combined epidural-general anesthesia is frequently used in     clinical practice. This anesthesia method provides advantages of both epidural and general     anesthesia, i.e. it blocks the afferent pathway of nociceptive stimulus by neuraxial blockade     during and after surgery, and allows patients to endure lengthy complicated operations     without any awareness. The investigators hypothesize that combined epidural-general     anesthesia and postoperative epidural analgesia can decrease the incidence of postoperative     delirium and, thus, improve the prognosis of critically ill elderly patients undergoing major     surgery. The purpose of this study is to compare the effects of combined epidural-general     anesthesia/postoperative epidural analgesia and general anesthesia/postoperative intravenous     analgesia on the incidence of postoperative delirium in elderly patients undergoing major     surgery.   "
124068|NCT01661894|"     The primary objective is to examine the efficacy of 8-weeks of a locally developed     brain-computer interface based system (BrainpalTM)intervention for improving attention and     memory in normal elderly. We hypothesize that elderly who have completed the training program     will have significant improvement in their attention and memory compared to the controls,     based on the Repeatable Battery for the Assessment of Neuropsychological Status.   "
124069|NCT01661881|"     Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to     improve upon standard of care in newly diagnosed, untreated MCL patients who were     transplant-eligible using drugs already established as active in MCL. The combination of     Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize     pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with     tolerable toxicity.   "
124070|NCT01661868|"     This research study is a way of gaining new knowledge about a drug called olaparib in women     who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1)     or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the     exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from     repairing their DNA. In this research study, we are looking to see how well the drug olaparib     works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well     as those who have received a prior PARP inhibitor and whose cancer has re-grown after     receiving that PARP inhibitor.   "
124071|NCT01661855|"     This study will examine the potential efficacy and safety of riluzole for core and associated     symptom domains of autism and will explore biological markers of safety and treatment     response.   "
124072|NCT01661842|"     Autoimmune hepatitis (AIH) is characterized by chronic inflammation of the liver, interface     hepatitis, hypergammaglobulinemia, and the presence of autoantibodies. Disease presentation     is varied but typically is based on characteristic aminotransferase elevations, histological     abnormalities, elevated levels of serum globulins, and the presence of one or more     autoantibodies. Two types of juvenile AIH have been identified according to seropositivity     for smooth muscle and /or antinuclear antibody (AIH type 1) or liver kidney microsomal     antibody (AIH type 2). Standard therapy in clinic consists of a combination of     corticosteroids and azathioprine, which displays the efficacy in 80% of patients. However, 7%     of patients deteriorate despite compliance with the standard corticosteroid regiments     (treatment failure),13% of patients improve but not to a degree that satisfies remission     criteria (incomplete response), 13% of patients develop serious drug-induced complications,     and 50%-86% of patients will relapse after drug withdrawal. These serious drawbacks     counterbalance the benefits of conventional therapy, and they are compelling reasons to     refine current treatment strategies and pursue alternative therapies. UC-MSC has been the     application for the treatment of several severe autoimmune diseases, such as immune     thrombocytopenia, systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis.     In this study, the safety and efficacy of UC-MSC transplantation for AIH patients will be     evaluated.   "
124073|NCT01661829|"     In patients who underwent sphincter preserving surgery with toal mesorectal excision and     diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators     would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal     function after stoma closure.   "
124074|NCT01661816|"     The study aims to analyse and decode interviews of patient with breast cancer, and then     established according a multidimensional profile specific to the population and to create a     questionnaire tha will allow a practical and qualitative evaluation of the quality of life.   "
124087|NCT01661647|"     Problem : Precise and personalized 3D knee kinematic assessment during physical and daily     life activities is a challenge; therefore, it was never performed on an important number of     individuals. However, a better understanding of 3D knee kinematics during such activities     would allow a better understanding of this often injured joint.      Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation     device that can be used under local anesthesiaallows for precise and reproducible assessment     of 3D knee kinematics during physical and daily life activities.      Objectives :        -  To study human knee 3D kinematics during dynamic activities using a novel minimally          invasive measuring system        -  Investigate the correlations between standard clinical knee laxity tests and measured 3D          knee kinematics during dynamic activities   "
124088|NCT01661634|"     The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous     (IV) ularitide infusion on the clinical status and outcome of patients with acute     decompensated heart failure (ADHF).   "
124089|NCT01661621|"     This study is a prospective randomized, open label, controlled, double arm, post-marketing     study to compare the treatment efficacy of first-line antimuscarinics and α-blockers     monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS)     (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio     (IPSS-V/S) ≤1.   "
124077|NCT01661777|"     The purpose of this study is to evaluate the benefit of treatment of refractory Eustachian     tube dysfunction with standard treatment for endolymphatic hydrops. Eustachian tube     dysfunction is a common diagnosis made in otolaryngology related to abnormal pressure     equalization of the middle ear space related to a swollen, inflamed, or occluded Eustachian     tube. The symptoms of this include perceived hearing loss, a feeling of fullness in the     affected ear/ears, ear pain, ear popping, and occasionally imbalance. These symptoms overlap     with a more rare and difficult to diagnose condition known as endolymphatic hydrops, or an     overproduction to fluid in the inner ear. The treatment for these two conditions are distinct     and traditionally, patients are treated for Eustachian tube dysfunction first as it is much     more common and there are several treatments, namely nasal steroids, antihistamines, and     pressure equalization tubes. For patients who do not improve with these treatments, they are     often treated with diuretics and a low salt diet to treat for supposed endolymphatic hydrops.     There has never been a study to investigate the utility of these treatments in patients with     refractory Eustachian tube dysfunction. There is also reason to believe that chronic ETD with     effusion can lead to both inner and middle ear dysfunction. Thus, this study aims to     determine the benefit of standard endolymphatic hydrops treatment on patient with refractory     Eustachian tube dysfunction symptoms in a prospective fashion.      Hypothesis:      Patients with refractory Eustachian tube dysfunction (patients with no or minimal symptom     improvement despite nasal steroid and antihistamine treatment followed by myringotomy tube     placement) have an element of endolymphatic hydrops and these patient's symptoms will improve     with a low sodium diet and diuretic.   "
124078|NCT01661764|"     Colorectal cancer is the second leading cause of cancer-related death within the United     States. Animal models and observational studies have suggested that marine-derived n-3     polyunsaturated fatty acids [PUFA] such as eicosapentanoic acid [EPA] and docosahexanoic acid     [DHA] may reduce the risk of colorectal cancer. In addition, it may be the relative     proportion of n-3 to n-6 PUFAs that best determines the chemopreventive effects of fish oils.     This ratio is important because the n-6 PUFA, arachidonic acid (ARA), is converted via the     cyclo-oxygenase (COX) pathway to prostaglandin E2 (PGE2), an inflammatory eicosanoid     overproduced in colorectal neoplasms while EPA is converted to the anti-inflammatory     prostaglandin E3 (PGE3). While the ratio of n-6 to n-3 PUFAs can be altered through dietary     changes, genetic factors may also influence this ratio. Recent genetic studies have     demonstrated that much of the tissue levels of ARA is determined by differences in a gene     called fatty acid desaturase 1 (FADS1). FADS1 is the rate-limiting enzyme in the conversion     of linoleic acid, the most commonly consumed PUFA in the Western diet, to ARA, and one     particular genetic variant caller rs174537 is associated with lower fatty acid desaturase     activity and subsequently lower tissue levels of ARA.      The study hypothesis is that individuals with genetically determined lower activity of FADS1     will derive greater benefit from fish oil supplementation than individuals with higher FADS1     activity because of lower tissue levels of ARA and subsequently a more favorable n-6 to n-3     PUFA ratio. To test this hypothesis the investigators will recruit 150 participants with     recently identified adenomatous polyps and conduct a 6-month double blind 3 X 2 factorial     randomized controlled trial. The first factor will be FADS1 genotype (GG, GT, and TT) and the     second factor will be fish oil supplementation (fish oil versus placebo). The primary outcome     will be the change in rectal epithelial cell growth and cell death. Secondary outcomes will     include rectal epithelial cell expression of genes important in PGE2 production, rectal cell     production of PGE2 and PGE3, rectal mucosal tissue levels of fatty acids, and changes in     biomarkers of inflammation (C-reactive protein), adipokines (leptin, adiponectin), and     markers of insulin sensitivity.      The specific aims include: 1) to determine the efficacy of fish oil supplements on rectal     epithelial cell proliferation indexes and markers of rectal crypt apoptosis, and 2) to     determine the effect of genetically-determined fatty acid desaturase 1 activity on fish oil     supplementation for colorectal cancer chemoprevention. The investigators long-term objectives     are to determine genetic factors that might influence the efficacy of fish oil     supplementation in order to conduct a more definitive adenoma recurrence trial using     marine-derived n-3 PUFAs. The investigators anticipate that fish oil will have     anti-neoplastic effect and individuals with low FADS1 activity will have a greater response     compared to individuals with high FADS1 activity   "
124079|NCT01661751|"     The clinical trial was designed to evaluate the safety and immunogenicity against Group     ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of     age and older.   "
124080|NCT01661738|"     The clinical trial was designed to evaluate the safety and immunogenicity against Group     ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of     age and older.   "
124081|NCT01661725|"     The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal     Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.   "
124082|NCT01661712|"     The aim of this randomized, double-blinded, sham-controlled cross-over trial is to     demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the     pharyngeal dilator muscles to reduce sleep-disordered breathing.   "
124083|NCT01661699|"     The purpose of this study is to check blood and urine levels to further define markers/tests     in the blood and urine that would be useful in following patients with obstructive sleep     apnea and then to see if by wearing CPAP every night, these markers can be reduced. This     research is being done because currently there are no effective blood or urine markers to     determine how well CPAP is working.   "
124084|NCT01661686|"     The purpose of this study is to determine whether fully covered or partially covered metal     stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary     outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a     stent or tumour related cause in a 6-month follow-up   "
124085|NCT01661673|"     This study is being conducted to determine the safety, tolerability, pharmacokinetics, and     effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and     in subjects with mild cognitive impairment or early Alzheimer's disease.   "
124086|NCT01661660|"     Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems,     behavioural and psychological symptoms (BPSD), and an impairment of activities of daily     living (IADL) are frequently encountered and usually show an impact on autonomy maintenance,     prognostic and care during the prodromal and early stages of the disease.      Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well     as their intensity increase with the evolution of the disease.      Apathy, initially defined as a reduction of motivated behaviours, is the most frequently     observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of     interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by     diminished goal-directed cognitions and behaviours.      Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These     are used to gather precise data regarding patient's clinical state from interviews with the     patient, the career or from clinical impressions during the consultation. From their apparent     simplicity they have made their way into daily clinical practices, yet neuropsychiatric     scales are reportedly biased by the assessors' subjectivity.      However, some tools whose allow simple, fast and objectively valid assessments are not widely     used.      Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities),     automatized audio-video recognition and signal analysis from events, may be of interest in     addition to current assessment methods.      The aim of this study is to implement an objective assessment of goal directed activities and     autonomy in an experimental design including predefined actions. The setting includes video     cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and     computer-based recognition of events using audio-video data, locomotion data and sinusal     variability respectively as well as extracting biomarkers for supporting detection of     dementia at early stages and supporting ongoing tracking of the dementia disease state. The     following population will be included: patients with Mild Cognitive Impairment (n=50),     patients with Alzheimer's disease (n=50) and control participants (n=50).      This work will provide further objective information for clinical practitioner in order to     detect behavioral disturbances such as apathy.   "
124092|NCT01661582|"     Exposure to particulate air pollution is associated with increases in cardiovascular     mortality and morbidity. The pathophysiological mechanisms underlying this observation are     emerging, and exposure to particulate air pollution has been shown to result in increases in     blood pressure and arterial tone, impaired vascular function and an increased tendency for     blood to clot as well as an increase in atherosclerotic plaque burden. Recent evidence from     panel studies and controlled exposure studies have suggested an increase in myocardial     ischaemia (a reduction in blood flow to the heart) following exposure. In this study we aim     to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust     (as a model of urban air pollution) using CT/PET myocardial perfusion imaging in male     patients with stable coronary disease and healthy male controls. We hypothesize that     following exposure to dilute diesel exhaust:        1. Myocardial blood flow will be reduced        2. Coronary flow reserve will be impaired        3. The magnitude of impairment will be higher in patients with coronary disease as compared          to healthy controls   "
124093|NCT01661569|"     We propose a randomised controlled trial in a workplace setting to investigate whether a     smartphone-delivered programme of mindfulness meditation influences psychological and     biological indicators of well-being.      We hypothesise that after 8 weeks participants who complete the meditation programme will     show increases in psychological well-being and reduced activation of stress-related     biological pathways.   "
124094|NCT01661556|"     Melasma is an acquired discoloration of the skin characterized by brown colour changes     commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The     control group will receive treatment with topical Hydroquinone (4%), and the other group     topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for     melasma patients. The estimated number of subjects to be recruited and randomized for the     study is at least 30. The purpose of this study is determine if there is a difference in the     effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be     assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry     and histological assessment will be also evaluated. Occurrence of adverse effects will also     be recorded.   "
124095|NCT01661543|"     The purpose of this study is to compare how regularly eating (dried) beans or peas or rice     (control) lowers blood lipids, particularly Low Density Lipoprotein cholesterol and total     cholesterol, in mildly hypercholesterolemic men and women. The investigators hypothesize that     regularly eating beans or peas will significantly improve blood lipid profiles in these     people.      Participants in this study will consume 1 study food item 5 out of 7 days a week containing     beans or peas or rice for a total of 6 weeks. This study will benefit Canadian pulse growers     by enhancing development of food products for human consumption and supporting marketing     strategies to increase awareness that a diet rich in pulses can improve human health.     Measuring changes in blood and urinary polyphenol levels will help to verify whether these     compounds play a role in the beneficial actions of beans and peas and subsequently assist     with the identification of the beneficial bean/pea components. This in turn, will enable crop     breeders to select for plants that are rich in these compounds.   "
124096|NCT01661530|"     In the last forty years the prevalence of asthma has increased in westernised countries. We     have hypothesised that this increase may be a consequence of changing diet. Several birth     cohort studies have now reported an association between reduced maternal vitamin E intake     during pregnancy and childhood asthma.      However, it remains to be seen whether increasing maternal vitamin E intake during pregnancy     reduces the risk of childhood asthma. We are planning a large placebo controlled trial in     pregnant women, to investigate whether optimisation of dietary vitamin E intake to the     recommended 15mg/day reduces the likelihood of childhood asthma. We believe that a dietary     intervention using vitamin E in its natural form of food is more likely to be successful and     acceptable than a vitamin E supplement. We have previously demonstrated than pregnant women     can optimise their vitamin E intake using a personalised dietary plan with the help of a     dietitian however this intervention was complex and could not be translated into everyday     use. With commercial support we have developed a range of soups containing foods naturally     rich in vitamin E designed to optimise maternal vitamin E intake to 15mg/day. A range of     similar tasting and looking placebo soups has also been developed. In this study we will     pilot a randomised controlled trial of the active and placebo soups to ascertain whether     pregnant women are willing and able to optimise their vitamin E intake during pregnancy using     the soups in order to reduce the risk of their child developing asthma. optimising maternal     vitamin E intake during pregnancy.   "
124097|NCT01661517|"     This study will be a quality improvement project to review the effectiveness and barriers to     effectiveness of a new clinical program in the emergency room to provide substance use     screening followed by brief motivational interviewing and referral to treatment for patients     who meet criteria for problem substance use. This study will consist of a chart review of the     results of the screens performed by substance use counselors and correlating them to     institutional variables such as wait time in the emergency room and length of stay as well as     to patient variables obtained by chart review such as medical diagnosis and sociodemographic     variables.   "
124098|NCT01661504|"     The overall goal of this proposed study is to develop the state of knowledge in the area of     gender-based violence and reproductive health by conducting a randomized controlled trial to     improve the health care provider's capacity to screen for intimate partner violence and to     mitigate associated risk among women health clinic patrons of reproductive age (ages18-44)     with recent experiences of physical or sexual partner violence in Mexico City and its     surrounding area.      The specific research objectives are as follows:        1. To increase mid-level health care providers' capacity to identify Intimate Partner          Violence (IPV) and assist women with risk mitigation        2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care          worker screening and counselling program on (a) past year severe IPV (sexual or          physical), including severe IPV; (b) reproductive coercion (c) use of community-based          resources and safety planning; and (d) quality of life; versus minimum standard of care        3. To qualitatively examine which programmatic components may serve as mechanisms for          observed changes stated in the second objective        4. To synthesize study findings and a) create recommendations for clinic-based intervention          programs to address IPV in low and middle income countries and b) disseminate          information as reports, presentation, and peer-reviewed publications   "
124099|NCT01661491|"     Cystic Fibrosis (CF) is a fatal, recessive genetic disorder characterized by progressive     inflammation and lung damage. It is unclear whether current treatment strategies, which focus     on detection and eradication of pathogenic microorganisms in the lung, are the best way to     prevent the initiation of early inflammation and lung damage. This study asks how early     acquisition of microbial flora occurs in infants with CF and healthy baby controls, and     whether this process initiates or influences early inflammation and clinical disease     progression in CF.   "
124100|NCT01661478|"     The purpose of this quality improvement research project is to briefly survey attitudes among     healthcare providers toward patients with substance use disorders before and after substance     abuse counselors are placed in the Emergency Room.   "
124101|NCT01661465|"     To ensure consistent documentation of alcohol and substance use, the emergency medicine is     initiating a new standard of care for substance use screening: the use of a brief     self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed     in triage. This questionnaire will allow emergency medicine patients presenting to the     emergency room. This study will also review medical records after one year of the index     emergency room visit to establish rates or re-presentation and hospitalization correlated     with different substance use.   "
124102|NCT01661452|"     A survey (patient self-report) of patients presenting to UAB emergency room, outpatient     trauma clinics and substance abuse center for symptoms of post-traumatic stress disorder and     maladaptive coping responses after the widespread tornado disaster that occurred in Alabama     in April 2011.   "
124103|NCT01661439|"     Preconceptional use of low molecular weight heparin (enoxaparin) and aspirin in patient with     recurrent miscarriages with positive anti phospholipid antibodies increase the implantation     rate and the duration of pregnancy with low complications to the mother and the baby.   "
124104|NCT01661348|"     Aim 1: Assess the effectiveness of the Prevena Incision Management System in decreasing     postoperative surgical site infections in the obese parturient undergoing non-emergent     cesarean delivery.      Aim 2: Assess patient satisfaction after using the Prevena Incision Management System     following a non-emergent cesarean delivery.      Our overall long term goal is to reduce morbidity and incidence of surgical site infection     (SSI) in obese parturient who undergo non-emergent cesarean delivery.   "
124105|NCT01661335|"     The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the     standard therapy will help children who receive chemotherapy to have less nausea and     vomiting.   "
124106|NCT01661322|"     The risk of recurrence is greatest immediately after stroke or Transient Ischaemic Attack     (TIA). Existing prevention strategies (antithrombotic, lipid/blood pressure lowering,     endarterectomy) reduce, not abolish, further events. Dual antiplatelet therapy - aspirin &     clopidogrel (AC) for IHD, aspirin & dipyridamole (AD) for stroke, is superior to aspirin     monotherapy. The investigators hypothesise that triple antiplatelet therapy (ACD) will be     superior to AD in patients at high-risk of recurrence, providing bleeding does not become     excessive.      Design: TARDIS is a multicentre, parallel-group, prospective, randomised, open-label,     blinded-endpoint, controlled trial. In the start-up phase, the investigators will assess over     3 years the safety, tolerability and feasibility of intensive therapy (ACD) versus guideline     therapy (AD) given for 1 month in 750 patients with acute stroke/TIA. The main phase will     then assess the safety and efficacy of ACD in up to 3500 patients. The primary outcome is     ordinal stroke (fatal/severe non-fatal/mild/TIA/none) at 90 days. Secondary outcomes include     death, MI, vascular events, function, bleeding, serious adverse events; sub-studies will     assess cerebral emboli and platelet function.   "
124107|NCT01661309|"     Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary     animal produce, which can elevate homocysteine. There is strong evidence indicating that     elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as     primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant     decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin     B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.   "
124200|NCT01660256|"     The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective     compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a     reference drug.   "
124273|NCT01659112|"     The purpose of the study is to determine the effects of the addition of core stabilization     exercises to a traditional upper extremity rehabilitation program in upper extremity     injuries.   "
124108|NCT01661296|"     Infections caused by the protozoan parasite Leishmania include cutaneous (CL), mucosal (ML)     and visceral leishmaniasis (VL). Over 12 million people currently suffer from leishmaniasis,     and approximately 2 million new cases occur annually, making it a major global health     problem. CL CL caused by Leishmania tropica is endemic around the city of Bikaner in Thar     Desert region of the State of Rajasthan . WHO recommends antimonials such as sodium     stibogluconate (SSG) to treat CL. However, these drugs are toxic and have poor patient     compliance as they require multiple intramuscular or intralesional injections for 3 weeks. In     addition, the emergence of drug-resistant strains is rapidly increasing worldwide. We are     interested in novel treatments for CL that are safe, easy to administer and effective in     inducing long-term cure. Recently, radio-frequency-induced heat (RFH) therapy has been used     to treat CL. This treatment involves the controlled and localized delivery of     radiofrequencies into lesions for 30-60 seconds under local anesthesia. Several short-term     follow-up (4-5 months) studies as well as one long-term follow-up (12 months) study involving     US soldiers who were infected with L. major in Iraq found that RFH therapy was comparable, or     even better, than systemic antimonials. However, more studies are needed to establish     long-term efficacy of RFH therapy in treatment of CL caused by other Leishmania species that     are difficult to treat with conventional drugs, and to determine the risk of disease     recurrence if any in patients living in Leishmania endemic regions. The goal of this trial is     to compare long term efficacy of RFH therapy in treatment of CL caused by L. tropica in     patients residing in Leishmania-endemic regions of India.   "
124109|NCT01661283|"     To determine the clinical response rate of everolimus in combination with bevacizumab for     patients with chemotherapy refractory sporadic or neurofibromatosis type 1 (NF1) associated     malignant peripheral nerve sheath tumor (MPNST). To evaluate the toxicity and safety of     everolimus in combination with bevacizumab in individuals with MPNST   "
124110|NCT01661270|"     Primary Objective:      To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo     in participants with metastatic colorectal cancer treated with FOLFIRI as second-line     treatment for metastatic disease.      Secondary Objectives:      To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response     rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To     assess immunogenicity of intravenous (IV) aflibercept in selected centers.   "
124111|NCT01661257|"     This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing     molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's     disease during anti TNF-α (infliximab) therapy.   "
124112|NCT01661244|"     RV568 is being developed as a possible treatment of smoking related lung disease (also known     as Chronic Obstructive Pulmonary Disease - COPD).      The main purpose of this study is to examine the safety and tolerability of a new inhaled     formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and     Part B. Part A (Cohorts 1, 2 & 3) will investigate 6 different dose levels of RV568 given as     a single dose and Part B (Cohorts 4 & 5) will investigate 2 different dose levels of RV568     given once a day for 14 days.   "
124113|NCT01661231|"     BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from     BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to     separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in     the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 stent will be used for the     treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA)     or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of     the common or external iliac artery lesions.   "
124114|NCT01661218|"     The investigators aim to determine the complications and risk factors related with     peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) in cancer     patients.   "
124115|NCT01661205|"     The purpose of this study is to assess the safety and technical feasibility of treating     subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation     in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar     System, with mapping and additional lesion creation/ gap closure (as needed) provided by     currently approved catheter technology, when the epicardial and endocardial phases are     performed in a staged manner within 1-10 days apart, during the same hospitalization.   "
124116|NCT01661192|"     At a previous study the investigators have assessed the safety and efficacy of treatment with     AAT(Alpha 1 Antitrypsin)in newly diagnosed type 1 diabetes subjects aiming at beta cells     preservation .      Since treatment with AAT is expected to be a chronic treatment; stopping treatment will     probably result in eventual loss of the preserved beta-cell function. Indeed, other     investigational drugs aiming at beta cells preservation have shown that patients who were     initially treated and maintained their initial beta-cell function, required continuation of     treatment or they lost the beta-cell function.      Therefore, in this extension study, patients who were previously treated with AAT and     maintained clinically significant beta-cell function are offered a continuation of treatment,     since they are likely to benefit from use of the medication.      The proposed study is aimed to assess the long term effect of AAT in subjects with type 1     diabetes mellitus: safety and tolerability of treatment, and effect on beta-cell function.      Subjects who have completed all visits of the 008 study will be offered to participate in the     extension study.      The study will be consist off two main arms as following:      Arm 1: Subjects who maintained peak stimulated C-peptide secretion ≥ 0.2 nmol/L will continue     treatment with AAT for up to 18 treatments according to the dosage group they were allocated     to in the 008 study.      Arm 2:      Subjects who have not maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L and subjects     with peak stimulated C -peptide secretion ≥ 0.2 nmol/L who are reluctant to receive     additional study drug.      Clinical follow up for all subjects in both arms will be for 3 years   "
124117|NCT01661179|"     Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese     Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.   "
124118|NCT01661166|"     The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity     (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and     to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients.     Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.   "
124120|NCT01661140|"     This randomized, placebo-controlled, double-blind study will compare the safety and efficacy     of tapering methotrexate (MTX) versus maintaining MTX dosage in patients with severe active     rheumatoid arthritis and an inadequate response to disease-modifying antirheumatic drugs     (DMARDs) initiated on treatment with tocilizumab. Participants will receive tocilizumab 8     mg/kg intravenously every 4 weeks and MTX orally weekly throughout the study. At Week 24,     participants achieving a good/moderate EULAR response will be randomized receiving the MTX     Tapering arm or MTX Maintenance arm. Up to Week 56 participants will receive either tapering     or stable dose MTX in combination with tocilizumab. From Week 56 to Week 72 participants will     receive tocilizumab monotherapy.   "
124121|NCT01661127|"     Psoriasis is associated with increases in markers of inflammation in the skin and blood and     increasingly is thought to be a systemic inflammatory disease and risk factor for incident     diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death.     Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial     emotional impact on an individual, which is not necessarily related to the extent of skin     disease.      FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner     that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that     chronic disease such as end stage renal disease with depressive symptoms have decreased     cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was     designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of     cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms     in patients with psoriasis.   "
124427|NCT01657071|"     The objective of this study is to compare pharmacokinetics after single oral administration     of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by     Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in     healthy male volunteers.   "
124122|NCT01661114|"     Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers     leading to responses in a substantial minority and increasing survival. The use of the     FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical     experience within the University of Michigan Pancreatic Program leads to an expectation of     tolerance and efficacy of the proposed regimen. Advantages of the proposed regimen relative     to FOLFIRINOX include:        1. Substitution of gemcitabine for irinotecan. Single agent activity of gemcitabine is at          least as good as irinotecan (probably better, especially when delivered by FDR          [fixed-dose rate] infusion) and gemcitabine is much better tolerated with less diarrhea,          nausea/emesis, myelosuppression and alopecia.        2. Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression,          mucositis and diarrhea.        3. Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold          aggravated dysesthesia.      Presuming evidence of efficacy and confirmation of tolerance with the proposed regimen, the     investigators believe this treatment may be more widely applicable to pancreatic-biliary     cancer patients, including those with advanced disease as well as being considered for use in     locally advanced and neo- and adjuvant settings.   "
124123|NCT01661101|"     Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying     than those who do not. One in 10 patients with myocardial injury will die within 30 days of     surgery. This risk of death exists up to one year after myocardial injury. There are     currently no treatments or guidelines available for heart injury after surgery, but there is     evidence that taking a blood-thinner can prevent some of the deaths, both in the short and     long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and     omeprazole) that may prevent mortality, major cardiovascular complications and major upper     gastrointestinal bleeding in patients who have had myocardial injury after noncardiac     surgery.   "
124124|NCT01661088|"     The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination     of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic     disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to     address local disease, will achieve a significant improvement R0 resection (Radiation     oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and     enhance disease free and overall survival in this patient population.   "
124125|NCT01661075|"     The purpose of this pilot project is to determine whether using inertial sensors placed on     the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS),     will be a more immediate, objective, reliable and sensitive way to measure and quantify     balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators     are also trying to observe if the sensors can be used to detect balance recovery after a     mTBI.      The investigators hypothesis is that collegiate atheltes with mTBI injury will have different     recovery periods between their cognitive testing(IMPACT) and their balance measures.   "
124126|NCT01661062|"     Cone beam CT (computed tomography) is a developing technology which allows CT images to be     obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to     produce detailed pictures of structures in the body.) In this study, cone beam CT scans will     be obtained before individual radiation treatment sessions for head and neck cancer. The     information gathered from these scans will be used by the researchers to look at patient     movement as well as changes in the amount of normal and tumor tissue throughout the course of     radiation therapy. The researchers will use this information to create hypothetical radiation     treatment plans, which will be used as the basis for future research. The cone beam CT scan     data will not be used to alter the actual radiation treatment of any of the patients enrolled     on the study. In addition, tests of salivary output and swallowing and questionnaires about     quality of life will be made to assess how the doses of radiation affect them.   "
124127|NCT01661049|"     To see how a cohorte of 55 patients over periode 1997-2011 were mannaged, treated and     survived duodenal cancer. Also to see how advanced the tumors were at time of diagnose and at     time of operation.   "
124133|NCT01660971|"     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and     dasatinib when given together with erlotinib hydrochloride in treating patients with     pancreatic cancer that has spread to other places in the body or cannot be removed by     surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Dasatinib and erlotinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and     dasatinib together with erlotinib hydrochloride may kill more tumor cells.   "
124128|NCT01661036|"     Background:      - The Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey is designed to look at     health-related topics. It is being developed for the Department of Health and Human Services.     Researchers want to see how easy or difficult the FLASHE survey questions are to understand     and answer. They will interview parents and teenagers to test the survey questions.      Objectives:      - To test the FLASHE survey questions on teenagers and their parents.      Eligibility:        -  Adolescents between 11 and 18 years of age.        -  Parents of the participating adolescents.      Design:        -  Participants will have a one-on-one interview to test the survey questions. The          interview will last up to an hour and a half. Participants will be allowed to skip any          questions that they do not wish to answer.        -  Participants will receive financial compensation for their time.   "
124185|NCT01660477|"     The purpose of this two part study is to assess the effect of multiple doses of isavuconazole     on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple     doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole.      Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or     isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to evaluate     safety and tolerability and to establish the effect of multiple doses of lopinavir/ritonavir     on isavuconazole.      Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone,     lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.   "
124452|NCT01656746|"     This study is being done to evaluate single incision laparoscopic surgery (SILS) for     colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended     to standardize the SILS technique for colorectal diseases   "
124129|NCT01661023|"     Background:      - Breast cancer is becoming more common in Africa. A higher number of cases appear in women     under age 35 than in the developed world. However, little is known about the factors that may     contribute to breast cancer in Africa. Researchers want to collect information from female     patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this information     with that obtained from healthy women in the general population. These two hospitals treat     most breast cancers in Ghana. The data will provide information regarding factors that     predispose to the development of breast cancer among women in Ghana.      Objectives:      - To identify and study breast cancer risk factors in women in Ghana.      Eligibility:        -  Women between 18 and 74 years of age who are diagnosed with breast cancer.        -  Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women without          breast cancer will be identified from the 2010 Ghanaian Census for comparison purposes      Design:        -  Participants will answer questions about their health and lifestyle.        -  Height, weight, and waist/hip measurements will be collected.        -  Blood and saliva samples will be collected.        -  Participants will be given a collection kit to collect a stool sample.        -  Treatment will not be provided as part of this study.   "
124130|NCT01661010|"     Purpose/Lay Summary: Background:      - Chromosomes are the structures inside of each cell that carry our genetic material (genes).     Certain differences in the sex chromosomes are known to cause various diseases, such as     infertility, Turner syndrome, or Klinefelter syndrome. However, it is not fully understood     why these differences are seen and what clinical findings may be caused with different sex     chromosome variants. This study is seeking to learn more about the genetic and clinical     characteristics of disorders related to the X and Y chromosomes.      Objectives:      - To study related medical conditions in people with sex chromosome variants.      Eligibility:        -  Patients with known sex chromosome differences may be eligible to participate.        -  Healthy volunteers age 18 - 55      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  This study will last about 5 days. Participants will have a variety of endocrine and          other tests. They will provide blood, urine, and semen samples for these tests.        -  Imaging studies of the heart and abdomen will be performed. These tests may include          ultrasounds and magnetic resonance imaging.        -  Participants will also have their vision and hearing checked.        -  Healthy volunteers with have a single day visit for a medical history, physical exam,          and blood and skin samples.        -  Treatment will not be provided as part of this study.        -  Compensation is offered.   "
124131|NCT01660997|"     Background:      - Smoldering multiple myeloma (SMM) is a condition that can lead to multiple myeloma, a type     of blood cancer. In many high-risk cases, SMM can develop into multiple myeloma in less than     2 years. The current standard of care for SMM is follow-up without treatment until multiple     myeloma develops. However, some drugs are being studied to see if they can slow down or     prevent the disease from progressing. One such drug is MLN9708. It has shown some results     against multiple myeloma. Researchers want to combine MLN9708 with dexamethasone to see how     it works against high-risk SMM.      Objectives:      - To see if MLN9708 with dexamethasone is a safe and effective treatment for high-risk     smoldering multiple myeloma.      Eligibility:      - Individuals at least 18 years of age who have high-risk smoldering multiple myeloma.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies and a bone marrow biopsy may also be          performed.        -  Participants will take MLN9708 and dexamethasone on a regular schedule for 28 days. They          will take each drug four times at regular intervals during each cycle of treatment.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Participants will have 12 cycles of treatment. After four cycles, patients will be          recommended to have their own stem cells collected and stored. This will allow the          potential application of a highdose melpahalan/autologous stem cell transplant in the          event there is a need in the future (not part of this study).        -  After 12 cycles, participants will keep taking MLN9708 as long as the disease does not          progress and the side effects are not too severe.   "
124132|NCT01660984|"     Background:      - Medullary thyroid cancer (MTC) is a rare cancer of the thyroid gland. In children and young     adults, it is often part of a condition called Multiple Endocrine Neoplasia 2 (MEN2). MEN2 is     usually caused by a genetic mutation, and it can cause a number of problems in addition to     MTC. These problems include adrenal gland tumors, hormone changes, and problems with the     bones and other organs. Not much is known about how MTC develops over time, especially in     people with MEN2. Researchers want to study MTC in children and young adults and see how it     affects their growth and development.      Objectives:      - To study how medullary thyroid cancer affects children and young adults over time.      Eligibility:      - Children and young adults younger than 25 years of age who have medullary thyroid cancer.      Design:        -  Participants will be screened with a brief physical exam and medical history. Blood and          tissue samples will be collected to see whether participants have the MEN2 genetic          mutation.        -  Treatment will not be provided as part of this study. However, participants will be          receiving standard care for MTC. They may be eligible for other clinical trials at the          National Institutes of Health.        -  Participants will have regular study visits every 6 to 12 months to evaluate their MTC          and any treatment. Blood tests, imaging studies, and other tests may be performed as          needed to monitor the disease.        -  Participants and their parents/guardians will also complete questionnaires about their          health and emotions during the study.   "
124186|NCT01660464|"     Cognitive-behavioral based guided self-help for parents of adolescents with     Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and     effectiveness study. The treatment is offered under routine-care conditions of the     health-care system in Germany. Practicability, treatment participation and effectiveness is     documented and tested in a one-group pre-test/post-test design.   "
124261|NCT01659268|"     The purpose of this study is to compare if there difference in acquisition of knowledge and     skills in airway management to baccalaureate nursing students submitted to different learning     strategies: exhibition-dialogued class and practical activity in skill lab with low-fidelity     mannequin or simulation class with low-fidelity mannequin.   "
124134|NCT01660958|"     Project Grow Smart evaluates the impact of a 12-month intervention of micronutrient-fortified     food and an early learning intervention on young children's cognitive ability. There is an     infancy phase and a preschool phase.      The infant phase is conducted through home visits - micronutrient sachets are distributed to     be mixed with food. The preschool phase is conducted in Anganwadi Centers. Hypothesis #1 is     that infants who receive both the micronutrients and the early learning intervention will     have better scores on measures of child development than children who receive neither.     Children who receive one of the two interventions will have intermediate scores. Hypothesis     #2 is that preschoolers in Anganwadi Centers that receive the micronutrient-enriched food wll     have better scores on measures of child development than children in Anganwadi Centers who do     not.      The preschool phase is conducted in Anganwadi Centers (AWC), which are like preschools.     Preschoolers age 36-48 months are recruited. AWC are classified as high or low stimulation,     based on a rating system (Early Childhood and Childcare Environmental Rating Scale, ECERS).     AWC are randomized into 2 cells: 1) multiple micronutrient-fortified food or 2)     placebo-fortified food. Preschoolers receive the food in the AWC; their mothers receive     information on iron-rich food. For both phases, evaluations are conducted at recruitment and     after 6 and 12 months and focus on changes in the children's cognitive performance and     micronutrient (iron) status.      The investigators hypothesize that innovative multiple micronutrient (MN) fortification     strategies for infants and preschoolers combined with early learning opportunities will     impact children's micronutrient status, growth and development in Nalgonda district of Andhra     Pradesh, India.   "
124135|NCT01660945|"     The investigator hypothesize that vytorin may improve vascular and insulin resistance in     hypercholesterolemic patients   "
124136|NCT01660932|"     The investigators hypothesize that omega does-dependently improves vascular and insulin     resistance.   "
124137|NCT01660919|"     The investigators hypothesize that rosuvastatin does-dependently worsens insulin sensitivity.   "
124138|NCT01660906|"     This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse     Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from     imatinib to dasatinib.   "
124139|NCT01660893|"     The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and     Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.   "
124140|NCT01660880|"     -  To estimate dopamine receptor occupancy by aripiprazole using computer simulation        -  To measure dopamine receptor occupancy by aripiprazole in patients treated with the          antipsychotics        -  To validate the simulation result by comparing the receptor occupancy from the          simulation with that from the patients   "
124141|NCT01660867|"     This is a prospective, randomized, controlled, double-blinded, clinical trial      Subject : 3mo ~ 24mo. aged infants with bronchiolitis      The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.   "
124142|NCT01660854|"     In a previous study (NL33904.091.10) the investigators challenged 24 volunteers after     Chloroquine Prophylaxis Sporozoites (CPS) immunization with 45, 30 or 15 infected     mosquito-bites respectively. The availability of this immunized cohort opens the unique     opportunity to determine protection to a heterologous challenge for both of the protected and     unprotected volunteers as the previous challenge infection might have served as immunological     boost to the unprotected volunteers.      In the current observational, proof of principle study, the investigators aim to investigate     the protection on an individual basis of these previously immunized and challenged volunteers     against a heterologous P. falciparum challenge.   "
124143|NCT01660841|"     Purpose of the study is to look at the safety (what are the side effects) and efficacy (how     well does it work) of gadobutrol when used for taking images of the brain and spine. The     results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images     taken without contrast (gadobutrol).   "
124144|NCT01660828|"     Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin     levels. The underlying mechanism is not yet elucidated, but could be explained by changes due     to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion     injury. If the mechanism underlying the troponin release during exercise is similar to that     of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic     preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this     hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding     RIPC.   "
124145|NCT01660815|"     This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed     throughout the body of Japanese subjects.   "
124146|NCT01660802|"     This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug     Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month     double-blind period versus sham followed by a 2 month open label period.   "
124147|NCT01660789|"     This study aims to evaluate the effect of a 40- week multifactorial intervention against     overweight, obesity and physical inactivity in Danish children.      The investigators wish to examine 40 children before and after the Fit for Kids     intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip     ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat     mass.      Furthermore the investigators wish to examine the more specific inflammatory, metabolic and     hormonal effect of the intervention with a more extensive examination programme.      The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer     monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and     inflammatory markers and an oral glucose tolerance test. The study will take place at Centre     of Inflammation and Metabolism, Rigshospitalet, Copenhagen.      The study is a randomised controlled trial with a gradual rollout. The 40 children will be     randomised. Twenty children will start the intervention at baseline and 20 children will     start after the first 20 weeks of intervention, thus providing a control group.      The investigators expect to find a significant reduction in BMI, total body fat mass and     systolic blood pressure after the intervention. As for the more extensive tests, the data     approach is explorative, as the investigators look at more statistical dependent variables.     The contribution of this project is a further description on the effect of intervention     against overweight and physical inactivity on the metabolic and inflammatory response.   "
124148|NCT01660776|"     Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in     western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent     chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this     disease remains a biologically heterogeneous entity. New therapeutic strategies are required     including identification of patients' subgroups with different prognostic.      This project is based on BMS_LyTrans and Goelams 075 clinical trial. A study of whole blood     transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was     overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in     plasma of DLBCL patients with a significantly higher concentration than in controls. This     protein was selected as a potential biomarker because of its established role in anti-tumoral     immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of     immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct     involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes     has been demonstrated. PD-L1 expression has been described in several solid tumours,     including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell     lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma.     Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The     blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers.     These first results incite to identify the cells releasing soluble PD-L1 and to investigate     its role in the anti-tumoral immunity in DLBCL patients.      The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at     diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer,     Hodgkin's lymphoma, non-small cell lung cancer).   "
124149|NCT01660763|"     The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA     System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute     moderate to severe post-operative pain after total unilateral knee or total unilateral hip     replacement surgery.   "
124150|NCT01660750|"     This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated     dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex)     prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant     eligible multiple myeloma.   "
124151|NCT01660737|"     The aim of this observational study is to document the therapeutic use of PASCALLERG ® for     hay fever. Based on the survey is a decrease in disease-specific symptoms when taking     PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility     can be assessed.   "
124152|NCT01660724|"     The main purpose of the study is to evaluate whether the routine use of ultrasound guided     arterial puncture can increase the proportion of patients who only needs one puncture attempt     in order to successfully extract enough blood to make an arterial blood gas analysis, when     ultrasound guided arterial puncture is compared to conventional arterial puncture technique.   "
124153|NCT01660711|"     The purpose of the study is to demonstrate that it is possible to administer chemotherapy     prior to and following surgery for pancreatic cancer which is considered operable. The     chemotherapy chosen is that which has been shown to be the most effective in treating     metastatic disease, and the goal is both to investigate whether this is tolerable and also to     investigate the efficacy of this approach in terms of disease response and survival.   "
124154|NCT01660698|"     The purpose of the current study is to evaluate the effect of administering a probiotic     strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in     seasonal allergic rhinitis subjects.   "
124155|NCT01660685|"     This is a randomized controlled trial with enhanced usual care treatment control. The aim is     to determine the effects of journaling and use of resource website on weight loss. There will     be two groups of 55 participants each. The intervention condition will be asked to record     daily weight, physical activity steps taken and pre-portioned food items and to complete two     daily journaling activities. Participants will also receive weekly tracing data, a weekly     blog from the principal investigator and have access to a weight control website. The control     group will not have access to the tracking, journaling or website for three months.     Investigators hypothesize that a website paired with tracking and journaling will be more     effective in helping participants lose weight.   "
124156|NCT01660672|"     Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%     and leaving one third of survivors with long term neurologic and psychiatric sequelae.     Seizures occur commonly with CM and are associated with an increased risk of death and     neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and feasibility     study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for     future efficacy studies aimed at improving seizure control and ultimately decreasing the     neurologic morbidity of pediatric CM.   "
124157|NCT01660659|"     Personal exposure to Indoor Air Pollution (IAP) is a known risk factor of severe pneumonia,     which is the number one killer of children under five in developing countries. The main     source of IAP in developing countries is cooking fires, with an estimated 3 billion people     still reliant on biomass stoves for their daily cooking. This study will test the     effectiveness of an intervention aimed to reduce IAP, as well as help to quantify the     relationship between exposure (IAP) and infection (pneumococcal carriage).      In Phase I (adjunct pilot study L2010.99), 3 fuels and 5 stoves were tested to measure     harmful pollutant emissions. The preliminary results showed that the largest difference was     found in the fuels (briquettes cleaner than wood), with a smaller difference found between a     couple of the improved stoves and the traditional 3-stone. Re-testing of selected stove/fuel     combinations to confirm findings has just been completed. Phase II (this proposal) will test     the biomass briquettes in a randomized clinical trial to measure actual IAP reductions in     households. A proof of concept pneumococcal survey will also be conducted as a secondary     study to see whether reduced exposure to IAP affects pneumococcal carriage in babies and     mothers   "
124158|NCT01660646|"     This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF)     strategy will be compared to passive TB case reporting in The Gambia. And that the impact of     ECF on community and household transmission of TB will also be assessed.      The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will     increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost     effective manner. The impact of ECF on community and household transmission of TB will also     be assessed. The investigators hope this trial will contribute to this evidence base. The     timing alongside a nationwide TB prevalence survey is particularly of benefit as that would     provide a baseline for disease burden against which the investigators may be able to compare     case notification or case detection in selected clusters   "
124159|NCT01660633|"     The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL     for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple     myeloma patients (MM) undergoing autologous transplantation.   "
124162|NCT01660594|"     Patients with stable chest pain presenting to general practitioners in UK are routinely     referred to the chest pain clinics in the hospitals. They are assessed by clinical history     including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT     calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying     calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical     Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who     have low likelihood of coronary artery disease (CAD). They recommend that patients with low     likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have     non-cardiac chest pain. However, there is controversy regarding relationship of absent     calcification with significant CAD and its prognostic value.      At our institution, we have been performing CTCS in this patient cohort since 2003. We plan     to retrospectively review the usefulness in CTCS in patients with different likelihood for     significant CAD, particularly in patients with absent calcium and compare with the     traditional assessment. We also plan to follow-up these patients for any myocardial     infarction and death from any cause.   "
124163|NCT01660581|"     The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells     in patients with angina resistant to pharmacological treatment and without the possibility of     effective revascularization. Cells will be isolated from patients bone marrow and     administered directly into the muscle of left ventricle. The main objective is to assess the     treatments' influence on improvement of myocardial perfusion and function, and on decrease of     occurrence of symptomatic angina.   "
124164|NCT01659788|"     The goal of the investigators research is to explore energy production of the ovarian     follicle in older reproductive age women at the time of oocyte retrieval.   "
124165|NCT01659775|"     This is a multicenter, randomized, open-label, paralleled-group, active-controlled study.      The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System     (GTDS) efficacy compared with the ondansetron efficacy with regard to Complete Response (CR)     of Chemotherapy Induced Nausea and Vomiting (CINV).      Patients scheduled to receive the one cycle of a HE chemotherapy regimen administered for 1-5     days will attend a Screening Visit 2 to 14 days before start of HE chemotherapy. Eligible     patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2     days prior to HE chemotherapy).        -  Sancuso patch        -  Zofran inj. + Zofran tab.      The patch will be applied 2days (48-24h) prior to first daily dose of the highly emetogenic     chemotherapy regimen and remain in place for 5 days after start of chemotherapy. The patient     will be assessed daily until 5days after first chemotherapy administration. Adverse Events     (AEs) will be collected until 2 days after the final dose of IP. Non-serious AEs will be     followed-up until 2 days after the final dose of IP. Serious adverse events will be     followed-up until they are resolved, stable or until the patient is lost to follow-up.   "
124166|NCT01659762|"     In this Phase I trial the investigators intend to show safety and tolerability of autologous     MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh,     non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a     dose escalation phase I study. The investigators intend to test whether the product is     clinically safe in adults (18-65 years old) with CD and to determine maximal deliverable     dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.   "
124167|NCT01659749|"     The purpose of this project is to study the effectiveness of teaching teens and young women     with Phenylketonuria (PKU) or Maple Syrup Urine Disease (MSUD) about their disease and     nutrition related issues in a camp environment. It will also look at pregnancy outcome     results in women with PKU who attended Metabolic Camp and compare their results to other     women with PKU who have not attended the Metabolic Camp.   "
124168|NCT01659736|"     This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by     conducting a pilot randomized-controlled trial (RCT) comparing structural     neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety     Disorder (GAD).   "
124169|NCT01659723|"     The primary objective of this study is to assess the relief of symptoms after Hyperbaric     Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate     cancer Index Composite (EPIC)symptom estimation scale as primary variable.      Study hypothesis:        -  HBOT can reduce or reverse the change or otherwise limit the damage of the bladder          function and/or structure, which arose as a result of radiation therapy of cancer in the          pelvic region organs.        -  The effects of HBOT are associated with relief of symptoms that, at least in part, is          related to the reduction of the extent of the radiation damage.        -  Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as          a sign of an improved function of the mucosa.        -  Treatment results of HBOT remains, in whole or in part, during the follow-up (residual          effect)   "
124170|NCT01659710|"     The purpose of this study is to research a new type of test for cerebral palsy that can be     performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test     involves a standardized video recording of a baby's natural movements for about 10 minutes.     The video recorded movements are evaluated by a special trained observer and also by a     computer program. There are some small studies from Europe that suggest that this type of     evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators     do not know if this type of evaluation is reliable in large groups of infants, including     infants from Children's Memorial Hospital, who tend to be sicker and have more complicated     illnesses than many of the European infants. The investigators would therefore like to     evaluate whether this type of video recording could be used in the future for early diagnosis     of cerebral palsy.   "
124171|NCT01659697|"     This study will evaluate the feasibility and efficacy of two interventions of lifestyle (     intensive and less intensive) to prevent diabetes in patients from Ethiopian origin, aged 25     to 55 years old with prediabetes living in Israel and insured by Clalit Health Services in     the Central district, using resources existing in this Health Care system (HMO).   "
124172|NCT01659684|"     Because the potential benefit of standard intravenous immunoglobulins (IVIG) - obtained from     unselected donor pools including a varying proportion of donors previously exposed to CMV -     has not yet been explored in pregnant women, the investigators performed a longitudinal     prospective study on the possible efficacy of IVIG for prevention or therapy of fetal CMV     infection.   "
124173|NCT01659671|"     Hypothesis:Pharyngeal surgery (UPPP) reduces significantly the nightly respiratory breathing     pauses (apnoeas-hypopnoeas) and improves the daytime symptoms compared to expectancy for 6     months in patients with OSAS.      Background: Obstructive sleep apnea syndrome (OSAS) is associated with an increased risk of     poor sleep quality, excessive daytime sleepiness and prolonged reaction time, which can     elevate the risk for traffic accidents. Increased morbidity and three to four times increased     mortality in these patients are well documented, mainly in the cardiovascular field.     Pharyngeal surgery, i.e. uvulopalatopharyngoplasty (UPPP) opens up the airway and was the     predominant treatment for OSAS worldwide before continuous positive airway pressure (CPAP)     devices became widely available in the 1990s. Since then, the main treatment for OSAS has     been CPAP, but an increasing number of patients are also treated with mandibular retaining     device (MRD). UPPP as treatment for OSAS has been performed for 30 years. The evidence-grade     for the efficacy has so far been very low, and the side-effects and complication rate has     raised the question whether there is a place for surgical treatment of OSAS. However, the     compliance for CPAP and dental devices are quite low (50-60%), leaving a lot of patients     untreated if surgery is not offered. RCT UPPP is still missing and called for.   "
124174|NCT01659658|"     The purpose of this study is to determine whether dexamethasone plus IXAZOMIB improves     hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and     mortality rate versus a physician's choice of a chemotherapy regimen in participants     diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.   "
124175|NCT01659645|"     Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010     leading to 39,840 cancer related deaths.      Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become     the a standard method for isolating the tumor. However, FDG is insensitive in small breast     tumors and certain histologic types such as lobular, certain types of breast carcinoma. In     addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also     evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging     tool that increases the ability to characterize detect breast carcinoma and to detect     locoregional spread, as well as monitor therapeutic treatment response.      anti-3-[18F]. anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid     based PET radiotracer which has shown utility in detecting a variety of tumors. In cell     culture experiments,FACBC has shown uptake in the breast tumor cell line.      The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within     breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics     via time-activity curves from dynamic imaging characteristics. The investigators will enroll     12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to     undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging     as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The     investigators will then compare findings to determine if this radiotracer is worthy of     further study in a more comprehensive experiment.   "
124176|NCT01659632|"     Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are     weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding.     Gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight     loss usually can not be cured. Therefore, early gastric cancer can not be detected and     impossible to treatment if endoscopy is performed according to the warning signs. National     gastric cancer screening is conducted in men and women of more than 40 years old. The purpose     of screening for gastric cancer is discovering a case of possible cure, so increasing the     survival rate. The purpose of this study is review of the feasibility of screening for     gastric cancer.   "
124177|NCT01659619|"     Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor     complex with longer and stronger contraction.      In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could     clear the stomach of blood, so visual examination could be improved.      Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is     postulated that erythromycin reduce food stasis and help to improve endoscopy in these cases.   "
124178|NCT01660568|"     We retrospectively review patients with refractory or relapsed ENKL who received a     gemcitabine-containing regimen   "
124179|NCT01660555|"     The human microbiota forms a highly complex ecosystem with its host, consisting of hundreds     of different species of microorganisms, the majority of which have not yet been cultured.     With the recent advent of small subunit rRNA (SSU rRNA) gene sequencing technology, it is     estimated that the number of specific gastrointestinal tract phylotypes is more than 1800.     Sampling techniques might constitute a major confounder in the read-out of highly sensitive     techniques such as SSU-DNA analysis.      It is not properly established whether there is a difference in distribution of luminal     bacteria or mucosa adherent bacteria proximal or distal in the colon. In addition, 'bowel     lavage' before endoscopy might result in a disturbance of the microbiota in the bowel. For     this proof of concept study a novel device capable of taking 'protected' biopsies has been     designed.      We hypothesize that the distribution of mucosal and luminal microbiota changes from proximal     to distal in the colon, and by taking 'protected biopsies' there will be the opportunity to     show the real distribution of microbiota according to the localisation in the colon.      Furthermore, we hypothesize that microbial diversity will differ after bowel lavage.   "
124180|NCT01660542|"     This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of     sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by     4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or     cytologically confirmed axillary lymph nodes metastasis.   "
124181|NCT01660529|"     Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV     multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab     20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the     time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine,     may continue to receive vaccinations every 4 weeks for up to 2 years.   "
124182|NCT01660516|"     Tea consumption may impact upon the decrease in endothelial function after IR-injury.     However, no previous study directly examined the potential of tea to impact upon the change     in endothelial function after IR-injury.      The investigators hypothesize that tea consumption counteracts endothelial damage in response     to ischaemia reperfusion injury in healthy humans.   "
124187|NCT01660451|"     The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in     patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after     standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group.     The objective of the study part B is to evaluate the efficacy and safety of BAY80-6946 in     patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the     part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers.     Quality of life will be a further objective of part B of the study.      In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed     to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.      After an up to 28-day screening period, eligible patients will start treatment with     BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).      Treatment will be continued until disease has progressed or until another criterion is met     for withdrawal from study. An end-of-treatment visit will be performed within 7 days after     discontinuation of study treatment. Thirty to 35 days after last study drug administration, a     safety followup visit will be performed for the collection of adverse events (AEs) and     concomitant medication data. Patients will be contacted quarterly to determine overall     survival status up to 3 years after last patient first treatment. In Part B, patients will     enter the Active Assessment Followup Period. The end of study notification to Health     Authorities will be based on the completion of the collection of survival data.      The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at     Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months     during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor     tissue and blood samples will be collected for biomarker analysis (mandatory) and for central     pathology review (part B), fresh biopsy tissue will also be collected if available.   "
124188|NCT01660438|"     This is a prospective, non-randomized, observational, multicenter study in which urethral     length is measured in women with surgically-correctable stress urinary incontinence who     undergo a suburethral sling operative procedure.   "
124189|NCT01660425|"     The main purpose of this study is to evaluate the effectiveness of a parenting enhancement     training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity     Disorder (ADHD) who are already medicated with methylphenidate.   "
124190|NCT01660412|"     Pain during nuclear medicine breast lymphnode detection procedures has been reported as high     as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain     can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.      In sites other then the breast, using Bicarbonate to make the injection's pH closer to     natural, attempts to lower the pain levels will be performed.      Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be     reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH     7.40.   "
124191|NCT01660399|"     This predictive, randomized, double-blind, multi-center trial is going to evaluate the     efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a     second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous     cell lung cancer patients.   "
124192|NCT01660386|"     The objective of this study is to demonstrate the different effects of two DPP-4     inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and     second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the     different effects of the study drugs on the GLP-1 response, and the glucagon concentration     which indicates alpha cell function in healthy subjects.   "
124193|NCT01660373|"     This is a single-center, open-label prospective randomized pharmacodynamic investigation of     two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment     elevation acute coronary syndrome(NSTE-ACS) for 24 hours        1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)        2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min             -  both agents will be given on top of aspirin   "
124194|NCT01660360|"     The primary objective of this study is to assess the safety, tolerability, and maximum     tolerated dose (MTD) of Tanibirumab in patients with advanced or metastatic cancer who are     refractory or for whom there are no standard therapeutic option.        -  To evaluate the pharmacokinetics of Tanibirumab in such patients        -  To determine a recommended phase II dose (RP2D) of Tanibirumab based on above          assessments   "
124195|NCT01660347|"     This clinical trial studies how well donor stem cell boost works in treating patients with     low blood cells after donor stem cell transplant. Donor stem cell boost may increase low     blood cell counts caused by hematologic cancer or its treatment.   "
124196|NCT01660334|"     To collect the efficacy and safety information of voriconazole related to their appropriate     use in daily practice.   "
124197|NCT01660321|"     A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in     pediatric subjects 6 months to 4 years of age with an active head lice infestation.   "
124198|NCT01660308|"     Fibroblast froth factors (FGFs) are humoral factors identified by their ability to stimulate     cell proliferation1. They play different roles in the regulation of cell proliferation,     differentiation and function. Most FGF family members act as paracrine factors. But     FGF19(FGF19) subfamily members, including FGF19, 21, and 23, work as endocrine factors to     regulate bile acid, carbohydrate and phosphate metabolism2. Of these, FGF23 plays an     important role in phosphate and bone metabolism3. FGF23 gene encodes 251 amino acids,     including a 24-amino acid signal peptide4. The secreted FGF23 is a protein consisted of 227     amino acids. It works by binding to a Klotho-FGF receptor 1c (FGF1c) complex5. FGF suppresses     the expression of type 2a and 2c sodium-phosphate cotransporters, which mediate phosphate     reabsorption in proximal tubules.6 FGF23 decreases 25-hydroxyvitamin D-1α-hydroxylase     expression and enhances 25-hydroxyvitamin D-24-hydroxylase expression6. Therefore, FGF23     reduces serum 1,25-dihydroxyvitamin D〔1,25(OH)2D〕, which stimulates intestinal calcium and     phosphate absorption. FGF23 decreases serum phosphate through the above mechanisms FGF23     over-expression might result in hypophosphatemic rickets and osteomalacia.      Tumor induced osteomalacia (TIO) is a paraneoplastic syndrome usually caused by benign     phosphaturic mesenchymal tumors. Symptoms are nonspecific, such as general weakness, fatigue,     and bone pain. Sometimes fracture may occurs. The responsible tumors are sometimes small and     difficult to detect. Tumors secrete FGF23. FGF23 reduced phosphate reabsorption in the     proximal tubules and decrease 1,25(OH)2D levels, which result in hypophosphatemia and then     osteomalacia.      The investigators would like to observe the changes of FGF23 in patients who receive     operation or medical treatment and hope this will benefit future treatment.   "
124201|NCT01660243|"     This study is being conducted to investigate the efficacy of MT-9938 compared with placebo     after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the     effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains,     especially those which recent research suggests have a positive correlation with overall     survival for this patient group. The study will consist of the following phases: Screening (1     to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating     in a Follow-up Visit (1 week after the last dose).   "
124202|NCT01660230|"     The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and     multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.   "
124262|NCT01659255|"     This is an open-label, multi-center, phase I dose-escalation study to investigate the safety     and tolerability of ONO/GS-4059 given as monotherapy to patients with relapsed/refractory NHL     and CLL.   "
124203|NCT01660217|"     This is a randomized controlled study. The control group will consist of adult subjects and     the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD),     who are visiting a dermatologist for a standard AD office visit. In the control group, only     verbal instruction (VI), the standard of care, will be provided. The intervention group will     receive a similar VI with an additional component: an eczema education handout, as well as an     individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease     flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise     instructions regarding treatment modifications for the above-mentioned variations in     treatment severity. To ensure that all patients ultimately receive the same level of care,     the control group will also receive an EAP at the end of their consultation.      The goal of this study is to assess subjects' perception in the provider's use of an EAP and     its effectiveness in helping patients understand their disease and management plan. In order     to evaluate the primary end-points, subjects in both the control and treatment groups will be     asked to complete post-consultation surveys. Four post-consultation outcomes will be     measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort     level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home,     and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither     the EAP nor the VI.   "
124204|NCT01660204|"     The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic     strategies for patients with community-acquired pneumonia admitted to the hospital, but not     the ICU.   "
124205|NCT01660191|"     The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin     or Rosuvastatin.   "
124206|NCT01660178|"     To describe the profile of newborns undergoing early stimulation in a neonatal intensive care     unit, characterizing the study population, according to its variables and neonatal risk     factors, indications for treatment of early stimulation.   "
124207|NCT01660165|"     There is increasing evidence that psychosocial factors may affect health by means of     biological effects and changes in behavioral health. Observational studies suggest an     association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic acid),     after pregnancy and the occurrence of postpartum depression (PPD). This is an observational     cohort with 4 waves of follow-up and a nested clinical trial with pregnant women residing in     the city of Rio de Janeiro. The general objective is to describe the magnitude and identify     factors associated to common mental disorders (CMD) during pregnancy and postpartum giving     emphasis to maternal nutritional status.      Main specific objectives:        1. To evaluate the effect of CMD in the pattern of occurrence of selected maternal and          child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low          birthweight, small for gestational weight and prematurity), considering the effect of          other determinant factors, and        2. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.   "
124208|NCT01660152|"     The purpose of this study is to determine which technique in using a vacuum erection device     (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern     for both the surgeon and the patient. Recent studies have shown that beginning to use the     vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile     shrinkage. This is a potential issue that can occur because of decreased blood flow after     prostate cancer surgery. This study will allow researchers to determine and compare vacuum     therapy techniques and erectile function outcomes of patients who have prostate cancer     surgery   "
124209|NCT01660139|"     This study is to assess the practice of complementary and alternative medicine (CAM) for skin     related conditions among patients in the Primary Care and Dermatology clinics.   "
124210|NCT01660126|"     Subclinical hypothyroidism (SCH) is a common condition among older men and women. Although by     definition SCH comprises biochemically mild thyroid hormone deficiency without overt     symptoms, it is a possible contributor to multiple problems in older age. Thyroid hormone has     effects on numerous physiological systems, including the vascular tree, heart, skeletal     muscle and brain. Therefore, thyroxine substitution to overcome thyroid hormone deficiency     has the potential to give multisystem benefits to older people with SCH.      Small studies have reported reduced atherosclerosis and improved heart function with     thyroxine replacement, but no large clinical trials have been performed. Therefore the     available evidence is limited, leading to major variations in guidelines and clinical     practice, with uncertainty regarding the indications for screening and treatment. The     investigators propose a multicentre randomised placebo controlled trial to assess the impact     of thyroxine replacement in a minimum of 540 older adults (maximum 750) with persisting SCH     (excluding those in whom it is a temporary phenomenon who are unlikely to benefit). The     investigators will include older men and women with a wide age range and of varying health     status. Outcomes include health related quality of life, muscle strength, executive cognitive     function and cardiovascular events, with a minimum of 1 year of follow up. Blood and urine     samples will be stored in a biobank, to allow future research on causes of ill health in     older people with SCH.      The investigators have the support of patient advocacy groups and a consortium with the wide     range of expertise and experience required to conduct large scale multicentre clinical     trials. The proposal explores the multisystem and quality of life benefits to older people of     a tailored approach to management of SCH.      This clinical trial should definitively clarify whether thyroxine treatment for SCH provides     benefits that are relevant for patients. This trial will provide strong evidence with the     potential to improve clinical practice, reduce health care costs and promote healthy ageing     of older adults.   "
124211|NCT01660100|"     Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF)     ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation     plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be     conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent     AF and Long Standing Persistent AF).      Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of     left atrial posterior wall is associated with more freedom from atrial arrhythmia at     long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.   "
124223|NCT01659944|"     The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg     twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in     healthy adults.      The secondary objective is to assess the safety and tolerability of a single oral dose of     metoprolol 50 mg when administered alone and in combination with repeated oral doses of     eliglustat 150 mg BID in healthy adults.   "
124224|NCT01659931|"     The objective of this study was to prove the bioequivalence of Montelukast Tablet under     fasted conditions   "
124225|NCT01659918|"     The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed     conditions   "
124226|NCT01659905|"     The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet     under fasted conditions.   "
124212|NCT01660087|"     The overall objective of this proposal is to develop a non-invasive, inexpensive and accurate     device that detects VOCs in exhaled breath for lung cancer screening. Toward this goal, the     team will design and fabricate a biophotonic platform consists of arrays of silicon     micro-ring resonator sensors coated with polymers with different organic functionalities, in     which each sensor is widely responsive to a variety of VOCs for the detection of lung cancer     by means of breath testing. The team will identify signature VOCs as lung cancer biomarkers     by comparison VOC contents between alveolar gas that directly sampled from the nodule or mass     and exhaled breath using gas chromatography/ mass spectrometry.      The specific aims of this proposal are as followings:      Aim 1: To develop a biophotonic platform for the detection of VOCs      Aim 2: To achieve multiplex detection of VOCs with high sensitivity and specificity using a     novel biophotonic device.      Aim 3: To evaluate the device as a lung cancer screening tool by testing both healthy and     lung cancer breath samples   "
124213|NCT01660074|"     The purpose of ths study was to evaluate the glycemic index and glycemic response of food and     products that produced in Tiwan. The food and product are in includes local produced fruits,     starchy food and bread made from resistant starch.   "
124214|NCT01660061|"     To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with     the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.   "
124215|NCT01660048|"     Since laparoscopic inguinal hernia was introduced in 1990, it has now become the most     commonly performed hernia repair in NSW. Traditionally this is done with 3 small incisions: a     2 cm incision under the navel for insertion of the camera and two 1 cm incisions below the     navel for insertion of trocars into which dissecting instruments are inserted to perform the     repair. Although this method has been shown to be relatively safe and efficient there are     reports of bowel and vascular injuries from the insertion of the smaller trocars which are     usually sharp. These can cause serious injuries.      Since 2009, a newer method of performing the key hole repair has been developed. This     involves placing a special single port under the navel via a 2-2.5cm incision and into which     3 blunt trocars are inserted. This negates the risks of injuries from sharp trocars. In     addition the fact that only a single incision is used this could potentially result in less     pain, reduced incidence of wound complications including infection and improved cosmetic     results.      However these potential advantages have not been proven in rigorous clinical studies as the     single port technique is still relatively new. It is hoped that this study will prove that     the single port technique is at least as effective and efficient as the conventional     technique in the cure of hernias and may have additional benefits as enumerated above.      Neither you nor your surgeon will know which procedure (three port or single port hernia     repair) until you are already asleep in the operating room and a random number selecting     process will automatically assign you to one procedure or the other. Sometimes it is not     possible to perform the single port safely in which case your procedure will be converted to     a three ports procedure.      All patients having surgical treatment of groin hernia at Holroyd Private Hospital are     subject to very careful assessment and study. All patients are requested to report     immediately if there are any problems. Any problems would normally be reported to your     treating surgeon who has primary responsibility for your care. Problems can be reported     directly to Holroyd Private Hospital. Any information in your medical records is subject to     stringent confidentiality requirements. The hospital is bound by the Australian Privacy     Council Charter as regards confidentiality and privacy.   "
124216|NCT01660035|"     The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in     the REVERSE and RAFT pivotal studies in real-world clinical practice.   "
124217|NCT01660022|"     A Phase I Study to investigate the safety, tolerability & pharmacokinetics of co-administered     single doses of OZ439 and Piperaquine to healthy subjects.   "
124218|NCT01660009|"     Prior work suggests exposure to low glucose levels (hypoglycemia) is associated with     increased cardiovascular risk. However, whether there is a causal relationship between     cardiovascular events and hypoglycemia remains unclear with conflicting data in the     literature. In this study, we plan to study whether acute exposure of patients to clinically     relevant (50-60 milligrams/deciliter) levels of hypoglycemia induces or worsens blood vessel     endothelial dysfunction- a key 1st step in the development of heart attacks and strokes. This     will be determined in humans both with and with type 2 diabetes.   "
124219|NCT01659996|"     The aim of the study is to further characterize the safety and immunogenicity of Menactra® in     the population <2 years of age when administered alone and when the second dose is     administered concomitantly with the 4th dose of Pentacel®, a licensed pediatric vaccine.      Primary Objectives:        -  To evaluate and compare the antibody responses to meningococcal serogroups A, C, Y, and          W-135 induced by 2 injections of Menactra® in subjects aged 9 months at the first          vaccination visit and 15 to 18 months at the second vaccination visit.        -  To evaluate and compare the antibody responses to Pertussis (pertussis toxoid [PT],          filamentous haemagglutinin [FHA] and pertactin [PRN]) antigens induced by a dose of          Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of          Pentacel® administered alone.        -  To evaluate and compare the antibody responses to polyribosylribitol phosphate (PRP),          tetanus and diphtheria antigens induced by a dose of Pentacel® when administered          concomitantly with Menactra® to those elicited by a dose of Pentacel® alone.      Observational Objectives:        -  To describe the safety profile (immediate unsolicited AEs within 30 minutes of each          trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited          AEs within 30 days of each vaccination, and serious adverse events [SAEs] throughout the          course of the trial from Day 0 up to Day 30 after the last trial vaccination[s]) in all          trial groups        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,          measured by SBA HC, 30 days after the second Menactra® administration        -  To describe the antibody responses to Pentacel® (PT, FHA, PRN, FIM, diphtheria, tetanus,          polio, PRP) measured by enzyme-linked immunosorbent assay (ELISA), radioimmunoassay          (RIA), or functional assays.   "
124220|NCT01659983|"     Research hypothesis:      Does delayed primary wound closure after appendectomy in adults with complicated appendicitis     reduce postoperative superficial surgical site infection compare to primary wound closure.      Study design:      This study is a multicenter randomized controlled trial of delay versus primary wound closure     in complicated appendicitis.      Setting:      Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira     Hospital, and Pathumthani Hospital      Participants:      Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as     gangrenous or ruptured appendicitis.      Outcome:      Superficial surgical site infection      Period of study:      August 2012 - August 2014   "
124221|NCT01659970|"     This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in     second line in patients with locally advanced or metastatic squamous non-small cell lung     cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients     will be followed for 12 months.   "
124222|NCT01659957|"     In treating alcoholism, many studies show Behavioral Couples Therapy (BCT) is more effective     than typical counseling, but BCT is not widely used because standard BCT delivered one couple     at a time is costly to deliver and does not fit with the primary group therapy focus of most     community clinics. The proposed study will test with married or cohabiting alcoholic patients     whether a group format for BCT will produce similar positive outcomes as standard BCT, and     deliver these results at a lower cost. If outcomes are favorable, this could prompt clinics     to start using group BCT and improve outcomes for alcoholic patients and their families.   "
124237|NCT01659580|"     This phase III study is designed as a double blind, randomized, multi-nation, multi-center,     placebo controlled clinical research, which aims to evaluate the safety and efficacy of     Dantonic® (T89) in patients with chronic stable angina pectoris.   "
124229|NCT01659866|"     This study is being conducted in men scheduled to undergo transrectal ultrasound-guided     prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic,     ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years as     ciprofloxacin resistance has increased in the community, more and more men are becoming     infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being     done to determine if obtaining rectal swab cultures and choosing antibiotics based on these     culture results will result in fewer infectious complications than giving all men     ciprofloxacin.      The investigators will compare 2 groups: men whose rectal swabs do not show     ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose     swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on     their culture results. Our hypothesis is that these 2 groups will have equal numbers of     post-biopsy infectious complications and both groups will have fewer infectious complications     than a historical group who received empiric ciprofloxacin without the benefit of rectal swab     culture results.   "
124230|NCT01659853|"     The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel     0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily     in subjects with moderate to severe facial erythema of rosacea.   "
124231|NCT01659840|"     The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the     same efficacy in relieving pain and improving the quality of life of TMD patients   "
124232|NCT01659827|"     The purpose of this study is to determine whether the AmnioFix Injectable human amniotic     membrane is effective in the treatment of recalcitrant plantar fasciitis.   "
124233|NCT01659814|"     The overall aim of this study is to utilize an integrative research model in order to     dynamically assess reward-related dopamine (DA) transmission in major depressive disorder     (MDD) and test the role of dysfunctional DA release in depression and anhedonia.      The first arm of this line of research (PET scan) aims to investigate phasic DA release in     MDD during incentive motivation. The investigators will utilize an established molecular     imaging technique to measure striatal DA release dynamically during performance of testing     and control versions of a monetary incentive delay task, which involves anticipation and     receipt of monetary rewards. In doing so, this experiment will link together independent     lines of research that have associated depression with decreased hedonic responsiveness,     impaired reinforcement learning and dysfunctional DA transmission. We hypothesize that,     relative to matched controls, unmedicated MDD subjects will show reduced reward-related     ligand (11C-raclopride) displacement. Reduced ligand displacement will be interpreted as     indicating reduced task-induced release of endogenous striatal DA in response to     reward-predicting cues and unpredictable reward in MDD subjects.      In the second arm of this research (EEG recording), the investigators aim to probe the     spatio-temporal dynamics of brain mechanisms underlying positive and negative reinforcement     learning in MDD and their relations to phasic DA. Participants will perform the probabilistic     stimulus selection task (PSST) while event-related potentials (ERPs) are collected. The     investigators expect that, relative to matched controls, unmedicated MDD subjects will show     reduced positive reinforcement learning, potentiated negative reinforcement learning, and     larger (i.e., more negative) feedback-related negativity (FRN) in response to positive     reinforcement (indicative of reduced DA transmission). Moreover, the investigators     hypothesize that a more negative FRN in response to positive reinforcement will be associated     with decreased striatal raclopride displacement (i.e., lower release of endogenous DA) as     measured by PET in the first part of the study. This experiment will investigate the effects     of blunted DA transmission on behavioral and ERP markers of both positive and negative     reinforcement learning.   "
124234|NCT01659801|"     With age, a human crystalline lens opacifies (cataract) disabling the eye in generating a     clear, well contrasted image. The only therapeutic solution to this problem is surgical     replacement of the crystalline lens with an intraocular lens (cataract surgery).      In addition to the cataract, the person might suffer from pre-existing cormeal astigmatism.     In cases of severe corneal astigmatism, the standard IOL might not provide the optimal     result, and additional surgical procedures as Incisional Keratotomy or Limbal Relaxing     Incisions might be required.      BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior     alternative to surgical treatment of pre-existing corneal astigmatism.      The BunnyLens TR IOL is designed for micro-incision cataract surgery (MICS), through 1.8mm     incisions.      The aims of this study are to:        -  Demonstrate a reduction in refractive cylinder compared to pre-operative corneal          astigmatism        -  Exceed monocular best corrected distance visual acuity results provided in ISO          guidelines.   "
124235|NCT01659606|"     Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically     causing failure of the blood system. Lung disease, liver disease and cancer are other     frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood     system but can make the lung and liver disease and risk of cancer worse, because of DNA     damaging agents such as alkylators and radiation that are typically used in the procedure.     Based on the biology of DC, we hypothesize that it may be possible to avoid these DNA     damaging agents in patients with DC, and still have a successful BMT. In this protocol we     will test whether a regimen that avoids DNA alkylators and radiation can permit successful     BMT without compromising survival in patients with DC.   "
124236|NCT01659593|"     Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the     disease. They effect personal life. Their management may be overlooked. The evidence-based     program proposes exercises to both stimulate preserved functions and develop new abilities     compensating for cognitive disabilities.      Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed     for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis     patients will be randomly assigned in one the program for 13 sessions over a 6-month period.      Main outcome criteria is evolution of SRT-LIST before and after program.   "
124244|NCT01659489|"     Adnexal torsion , is a severe, though uncommon gynecological emergency, with a prevalence of     2.7-3%. The need for prompt diagnosis and treatment in order to save ovarian tissue has been     realized a long time ago. A marker that will aid in the diagnosis of torsion and prevent     missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of     unecessary laparoscopic interventions is much needed. To our knowledge, such marker has not     been found. The purpose of this study is to find a marker using blood/serum from patients     undergoing laparoscopy for suspected ovarian torsion   "
124257|NCT01659320|"     This research study will examine whether elderly depressed patients whose depressive symptoms     do not respond satisfactorily to therapy with a mood stabilizer or antidepressant alone gain     any benefit from taking minocycline alone or in addition to their antidepressant or mood     stabilizer medication. Minocycline is a commonly used antibiotic medication with     anti-inflammatory properties. It is hoped that information gained from this study will help     the investigators better understand the role of inflammation in depression, and whether     decreasing inflammation will lead to improvement in the symptoms of depression and cognitive     function.   "
124281|NCT01659008|"     Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the     amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding   "
124245|NCT01659476|"     The objectives of this research are to compare (i) the bronchodilating and (ii) the     bronchoprotective effects of deep inspirations (DIs) in individuals with: (a) asthma, (b)     CVA, (c) methacholine-induced cough but normal airway sensitivity and .      (d) in healthy individuals (without asthma, chronic cough or asymptomatic airway     hyperresponsiveness).      Hypotheses:      i. The bronchodilating effect of a DI will be: (a) absent or impaired in individuals with     classic asthma; (b) impaired in individuals with CVA; (c) preserved in individuals with     methacholine-induced cough but normal airway sensitivity; and (d) preserved in healthy     individuals (without asthma, chronic cough or asymptomatic airway hyperresponsiveness).      ii. The bronchoprotective effect of a DI will be: (a) absent in individuals with classic     asthma; (b) impaired in individuals with CVA; (c) preserved in those with     methacholine-induced cough but normal airway sensitivity; and (d) preserved in healthy     individuals (without asthma, chronic cough or asymptomatic airway hyperresponsiveness).      iii. Healthy individuals without asthma, chronic cough, or asymptomatic airway     hyperresponsiveness, will not cough, or develop significant dyspnea, small airways     obstruction or dynamic hyperinflation during high-dose methacholine bronchoprovocation.   "
124246|NCT01659463|"     Material for caries prevention dont have better results compared with non-operatory     interventions.   "
124247|NCT01659450|"     Investigators presumed that low energy density (LED) diet consumers will have lower risk of     cardiovascular disease and are able to maintain their weight longer .   "
124248|NCT01659437|"     This is a WHO-sponsored trial.      Combination therapy with streptomycin and rifampicin has been the standard antibiotic     treatment for M. ulcerans infection since 2004. In March 2010, a WHO Technical Advisory Group     recommended that a trial be carried out to develop a fully oral treatment for the disease.     Although the current treatment is effective, injection with streptomycin is a problem.     Several small observational studies (published and unpublished) have shown that a fully oral     treatment is promising.      This WHO sponsored study will be a randomized, controlled open label non-inferiority phase     II/III, multi-centre trial (1 centre in Benin and 4 centres in Ghana), with two parallel     treatment groups. The ultimate goal is to search for an effective alternative treatment to     the current standard WHO-recommended therapy for all forms of Buruli ulcer, which includes     injections of streptomycin with inherent logistic, operational and safety disadvantages.      Financial and material support:        1. American Leprosy Missions, USA        2. Raoul Follereau Foundation, France        3. MAP International, USA        4. Sanofi, France        5. 7th Framework Programme of the European Union: BuruliVac project (241500)        6. Aranz Medical Limited, New Zealand   "
124249|NCT01659424|"     Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy     given with chemotherapy at the same time. External beam radiation can increase side effects     both short and long-term by exposing normal tissue nearby the tumor such as the bladder,     bowel and sexual organs. Instead, this study will use a different way of delivering radiation     called brachytherapy to decrease normal tissue radiation exposure. Patient will be given     three chemotherapy medications both before and after surgery: oxaliplatin (also called     EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic     Acid).      The purpose of this study is to find out whether giving chemotherapy and brachytherapy before     surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the risk of     tumor recurrence 3) avoid patient having the side effects related to chemotherapy and     external beam radiation therapy and 4) improve patient's ability to complete chemotherapy.   "
124250|NCT01659411|"     Multi-center, observational, U.S.-based longitudinal program. Data will be collected     prospectively for 3 years. Individual physician feedback will be provided on data collected     with the purpose of improving the management of patients - quality enhancement research     initiative (QuERI) process from adult patients enrolled with a history of repaired Congenital     Heart Disease (CHD).   "
124251|NCT01659398|"     The aim of this study is to investigate whether enhanced external counterpulsation (EECP)     therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time     enhance or slow down breakdown of cognitive function in patients diagnosed with mild     cognitive impairment (MCI).   "
124252|NCT01659385|"     The purpose of this study is to evaluate Leptin levels in females, in the setting of     papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid     disease.   "
124253|NCT01659372|"     tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular     joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause     pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the     major complaint.we run this investigation to find the analgesic effct of low level laser     therapy versus pharmacotherapy with naproxen in improving pain.   "
124254|NCT01659359|"     In recent studies using virtual reality has been proposed as a non pharmacological methods     for pain relief but until this time , its effects has not been assessed on pain and anxiety     during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain     and anxiety in Primiparity women during episiotomy repair.   "
124255|NCT01659346|"     Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be     screened for presence of large esophageal varices and will be randomized between     non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed     to assess the rate of reduction of index bleed rate as well as survival difference between     the groups.   "
124256|NCT01659333|"     Dry weight (DW) assessment is essential for the efficient treatment of peritoneal dialysis     (PD) patients but so far objective methods for DW assessment have not been established for     daily clinical practice. Our aim was to evaluate hydration state in PD patients by using a     body composition monitor (BCM) and calf bioimpedance (c-BI) and N-terminal prohormone of     brain natriuretic peptide (NT-proBNP) levels and to compare both methods with arterial     stiffness.   "
124258|NCT01659307|"     This is a double-blind, placebo-controled, randomized trial to investigate if aspirin     pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by     inhaled endotoxin (LPS) in healthy human volunteers.   "
124259|NCT01659294|"     This study will examine whether patients with diabetes who are either 1) newly discharged     from hospital or 2) referred to an endocrinologist for management will have better diabetes     outcomes when their care is managed primarily by a dedicated case manager (intervention) than     by an endocrinologist (standard care) after 6 months of treatment.   "
124263|NCT01659242|"     In rheumatoid arthritis patients with active disease despite optimal treatment with     methotrexate, the main objective of this pilot study is to use advance imaging tools such as     magnetic resonance imaging and ultrasound to evaluate which treatment option is more     efficacious: initiating methotrexate/sulfasalazine combination therapy, or switching to     leflunomide monotherapy   "
124264|NCT01659229|"     The investigators are comparing the range of movements the knees of patients who had total     knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a     Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee     system designed to combine function with wear resistance. It can accommodate up to 150     degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which     can accommodate up to 120 degrees of flexion.   "
124265|NCT01659216|"     The purpose of this study is to determine whether electrical pudendal nerve stimulation with     acupuncture needles as electrodes has a good long-term therapeutic effect on the     urgency-frequency syndrome in women.   "
124266|NCT01659203|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational intervention. Phase I studies also try to define the appropriate dose of     the investigational therapy to use for further studies. Investigational means that the     intervention is still being studied and that research doctors are trying to find out more     about it.      Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen.     Typically, patients with retroperitoneal sarcomas either have surgery for the removal of     their tumors alone, or have their tumors removed, followed by standard radiation therapy, or     have pre-operative radiation followed by surgery. When conventional radiation therapy is     delivered after surgery, it can damage normal tissue. In this study, you will undergo proton     beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.      Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny     particles with positive charge that can be controlled to travel a certain distance and stop     inside the body. In theory, this allows better control of where the radiation dose is     delivered as compared to photons. Since proton radiation is more targeted, it may help to     reduce unwanted side effects from radiation.      In this study, a standard dose of radiation will be given to the majority of the tumor, while     a simultaneously integrated boost of additional radiation will be given to certain areas of     the tumor identified as higher risk. This means that a higher radiation dose will be given to     the higher risk areas of the tumor.      The purpose of this study is to determine the highest dose of radiation therapy with protons     or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the     effectiveness of proton beam radiation therapy as an intervention for patients with     retroperitoneal sarcomas.   "
124267|NCT01659190|"     Urinary infection is one of the most common bacterial infections in pediatrics and requires     urine collections to be diagnosed. In France, among children under 3, urine samples are     collected thanks to collecting bags.      Work teams have set as their main goal to compare the different levels of acute pain involved     for children under 3 during the removing of the collecting bag, depending on the use, or not,     of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main     endpoint, the difference between the results assigned to the acute pain by a pain evaluation     scale (FLACC: Face-Legs-Activity-Cry-Consolability).   "
124268|NCT01659177|"     The study will evaluate the effect of food on absorption of LY2140023 in blood. This study     involves a single dose of 80 mg LY2140023 taken as a tablet by mouth on 2 occasions, once on     an empty stomach and once after eating breakfast. There is a minimum 3 day washout between     doses. This study will last approximately 16 days not including screening. Screening is     required within 30 days prior to the start of the study.   "
124269|NCT01659164|"     The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of     a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is to     build relational skills, skills in organizing and structuring everyday life, handle difficult     emotions and impulses etc. The treatment will be in a group format and it is hypothesized     that the psychological intervention will result in reduced ADHD symptoms and to decreased     experience of stress and depressive symptoms. The uncontrolled design does not allow for any     causal inferences from the results, this pilot study is primarily to be seen as a preparation     before a subsequent RCT.   "
124270|NCT01659151|"     The purpose of this study is to find out more about the effects of an investigational     combination of medicines, which includes special immune cells (T-cells).      A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood     cell that protect the body from viral infections, help other cells fight bacterial and fungal     infections, produce antibodies, fight cancers, and coordinate the activities of other cells     in the immune system.   "
124271|NCT01659138|"     Primary Objective:      To assess the efficacy of SAR339658      Secondary Objective:      To assess the safety of SAR339658   "
124272|NCT01659125|"     The primary aim of this study is to learn about who is most likely to benefit from guided     self-help (GSH) for obsessive-compulsive disorder (OCD).   "
124274|NCT01659099|"     This study is designed to investigate:        -  the interest of a new monoclonal antibody (GA101)versus rituximab        -  the interest of PET to identify early responders      Patients will receive either rituximab (standard treatment), either GA101 (study treatment),     according to the randomization arm.      The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to     site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and     after 4 chemotherapy cycles, to identify early patients responders, for who consolidation     with ASCT is not required.   "
124275|NCT01659086|"     The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of     different formulations of a two-dose primary series and booster vaccination of monovalent     Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18     to 64 years of age.   "
124276|NCT01659073|"     The investigators propose that Arterial Spin Labelling Functional Magnetic Imaging will be     able to capture functional changes associated with caloric vestibular stimulation and better     delineate the etiology of the pain augmentation that has been documented with this     intervention.   "
124277|NCT01659060|"     The purpose of this study is to to test the feasibility of design methods and procedures for     later use on a larger scale and to examine the acute and chronic effect of consumption of     flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.   "
124278|NCT01659047|"     The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and     duration of tumor control   "
124279|NCT01659034|"     The purpose of this study is to evaluate safety of reduction of thienopyridine treatment     period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.   "
124280|NCT01659021|"     This study will evaluate the effect of the addition of idelalisib (GS-1101) to ofatumumab on     progression-free survival (PFS) in participants with previously treated chronic lymphocytic     leukemia (CLL).   "
124282|NCT01658995|"     This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be     conducted within the Mayo Clinic and the Mayo Clinic Health System.      The goal of the research study is to gather information to determine whether Doxycycline is     effective for the treatment of unacceptable bleeding associated with the etonogestrel     subdermal implant (ESI), as compared to placebo.   "
124283|NCT01658982|"     Optimizing patient survival and organ utility is a constant struggle for the liver transplant     community. Despite rigorous cardiovascular evaluation before liver transplantation     cardiovascular events are one of the leading causes of post-transplant morbidity and     mortality in both early and late post transplant periods. Poor performance on measures of     cardiopulmonary fitness has been associated with worse outcomes in liver transplant     candidates. The investigators seek to determine the feasibility of obtaining measures of     cardiopulmonary performance in liver transplant candidates from standard cardiopulmonary     exercise testing (CPET) and from a modified 3 minute step test and to determine whether the 3     minute step test is suitable for the assessment of cardiopulmonary fitness in a future     outcome study.   "
124284|NCT01658956|"     The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile     neutropenia among patients with breast cancer, treated with chemotherapy and presenting with     a low to moderate risk of developing febrile neutropenia.   "
124285|NCT01658943|"     This randomized phase II trial studies how well selumetinib and Akt inhibitor MK2206 work     compared to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) therapy in     treating patients with metastatic pancreatic cancer previously treated with chemotherapy.     Selumetinib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, and     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. It is not yet know whether selumetinib and Akt     inhibitor MK2206 are more effective than oxaliplatin and fluorouracil in treating patients     with metastatic pancreatic cancer.   "
124286|NCT01658930|"     The reason this study is being done is to see if a simple hysterectomy is as good as a     radical hysterectomy in preventing cancer of the cervix from returning, and whether, because     less tissue surrounding the uterus is removed during surgery, there are fewer side-effects     after the surgery and in the long-term.   "
124287|NCT01658917|"     Background:      The NCI Surgery Branch has developed experimental therapies that involve taking white blood     cells from patients' tumor or from their blood, growing them in the laboratory in large     numbers, and then giving the cells back to the patient.      Objective:      This study will allow tissue samples obtained during the protocol screening process to be     used for future and ongoing research in the NCI Surgery Branch      Eligibility:      Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment     Protocol      Design      Patients will undergo testing and evaluations as required by the appropriate NCI Surgery     Branch Treatment protocol   "
124301|NCT01658735|"     The intent of this project is to execute a high-quality double-blinded randomized controlled     clinical trial that compares the H-Wave® device with a commonly used TENS device with a     sub-therapeutic electrocurrent device. This study will provide a definable level of evidence     for treatment efficacy, and provide a basis for evidence-based recommendation for or against     utilization for these two modalities. The results for H-Wave® device, if positive, could     significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for     symptomatic relief, and reduce overall disability and health care costs associated with     chronic low back pain.   "
124302|NCT01658722|"     A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in     Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies     ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.   "
124322|NCT01658449|"     The purpose of this study is to compare the tolerability and acceptability of a formulation     containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic     acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance     to HS.   "
124288|NCT01658904|"     Background:      - Plasma cell myeloma is a type of cancer that affects the plasma cells in the bone marrow.     It can be difficult to treat with chemotherapy. One possible treatment combines chemotherapy     with a stem cell transplant. To make this treatment more effective, researchers want to give     another drug along with the transplant. This drug, carfilzomib, is often used to help treat     plasma cell myeloma. However, it is not usually given along with the transplant. Researchers     want to see if it is safe and effective to combine the stem cell transplant with carfilzomib,     and if it improves the results of the transplant.      Objectives:      - To test the safety and effectiveness of carfilzomib given with stem cell transplant for     plasma cell myeloma.      Eligibility:      - Individuals between 18 and 75 years of age who are having a stem cell transplant to treat     plasma cell myeloma.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies and a bone marrow biopsy will also be          performed.        -  Participants will have their own stem cells collected for the transplant. The transplant          will be performed according to the standard of care.        -  All participants will receive carfilzomib on the first 2 days after transplant. The          study doctors will determine the number of additional doses that they may have.        -  Treatment will be monitored with frequent blood tests and imaging studies.   "
124289|NCT01658891|"     single center, double-blind, double-dummy, 2-way cross over study in asthmatic children     already treated with inhaled corticosteroids   "
124335|NCT01658280|"     The main purpose of the present study is to assess whether the sensitivity of     Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of     conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.   "
124336|NCT01658267|"     This study will assess compliance with dietary recommendations, in conjunction with a     nutritional supplement to meet the nutritional requirements in children and the effects of     the compliance on promoting growth in children who are at risk of under-nutrition.   "
124380|NCT01657682|"     This pilot Phase II study is designed to evaluate the efficacy and tolerability of crenolanib     in two cohorts of AML patients with FLT3 activation mutations (patients whose leukemia has     recurred after prior chemotherapy not including a FLT3 TKI and patients whose leukemia has     progressed after prior therapy with a FLT3 TKI).   "
124290|NCT01658878|"     The first part of the study is the Dose Escalation Phase designed to establish the safety of     nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular     carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B     virus (HBV)-infected subjects).      The second part of the study is the Expansion Phase designed to generate additional clinical     data at specified doses for each of the 3 cohorts. A third cohort has been added in this     study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A     fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus     ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data     will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added     to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and     nivolumab with ipilimumab in combination with cabozantinib.   "
124291|NCT01658865|"     The purpose of this study is to assese esophageal motor function by simplified transnasal     endoscopy compared with esophageal manometry.   "
124292|NCT01658852|"     Recent study showed that SIBO is common among postgastrectomy patients and It appears to be     associated with postprandial intestinal symptoms and might aggravate late hypoglycemia. SIBO     could be a new therapeutic target for managing intestinal symptoms in postgastrectomy     patients.The purpose of this study is to determine whether antiboitic (metronidazole) is     effective in patients with postgasrectomy syndrome   "
124293|NCT01658839|"     The purpose of this study was to assess the safety and describe the steady-state plasma     pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation)     following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension     patients.   "
124294|NCT01658826|"     The aim of the study is to evaluate the safety and efficacy of AIC316 (pritelivir) 100 mg     once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital     shedding.   "
124295|NCT01658813|"     The purpose of this study is to determine whether the combination of a 5-Fluorouracil (5-FU)     and interferon, which is able to stimulate the immune system to kill cancer cells, will help     to increase tumor shrinkage in previously-treated metastatic gastrointestinal, kidney, or     lung Cancer.   "
124296|NCT01658800|"     The purpose of this study is to test an investigational vaccine known as VAX161C. An     investigational vaccine is one that is not licensed for commercial use in the by the United     States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the     influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject     will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate     wants to find out how safe these doses of vaccines are and how well they are tolerated by     people who receive them. To measure how effective each type of the vaccine is, VaxInnate will     test the ability of the body to develop an immune response, which means how the body     recognizes and defends itself against the influenza virus.   "
124297|NCT01658787|"     Prospective, observational Registry to obtain data on device performance and clinical     outcomes.   "
124298|NCT01658774|"     Many school children in Kenya are infected with plasmodia and helminth species and are at     risk of coinfection. It has been suggested that the immune response evoked by helminth     infections may modify immune responses to plasmodia species and consequently alter infection     and disease risks. However, studies conducted to date have been typically cross-sectional and     produced conflicting results, and there is a need for longitudinal studies to better     understand the clinical consequences for individuals harbouring coinfection. This study aims     to investigate the impact of intensive (once every 3 months) anthelminthic treatment versus     annual treatment on the risk of clinical malaria and on immune responses among school     children aged 5-14 years in Western Province. Specifically, this study aims to investigate     the impact of intensive anthelminthic treatment on (i) the incidence of clinical malaria in     school children, assessed using active case detection; (ii) the prevalence and density of     Plasmodium spp. infection, using repeat cross-sectional surveys; and (iii) malaria and     helminth specific immune responses. The study hypothesis is that intensive anthelminthic     treatment among children infected with either Ascaris lumbricoides or hookworm modifies human     host immune responses to plasmodia and helminth infections, and therefore alters the risk of     Plasmodium infection and clinical disease.      This individually randomised trial will recruit 1,450 children aged 5-14 years found to be     infected with either Ascaris lumbricoides or hookworm species. Recruited children will be     randomized to receive albendazole treatment either every three months or annually and     monitored through periodic surveillance for clinical malaria episodes over 18 months. In     addition, blood samples will be collected from sub-sample of children and screened for     malaria specific immunoglobulin (Ig)G1 and IgG3 and helminth specific IgE, IgG2, IgG4 and     IgM. Cell culture supernatants will be assayed for interferon (IFN)-γ, tumor necrosis factor     (TNF)-α, interleukin (IL)-10, IL-5, IL-4 and IL-2.   "
124299|NCT01658761|"     Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was     evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it     may improve visual outcome.   "
124300|NCT01658748|"     The purpose of this study is to determine whether deep brain stimulation of the basolateral     nucleus (BLn) of the amygdala, on both sides of the brain, can safely reduce symptoms of     post-traumatic stress disorder (PTSD) in combat veterans whose condition has not improved     despite extensive treatment with currently available medication and psychotherapy     interventions.   "
124333|NCT01658306|"     The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a     beneficial effect on outcomes of cerebral small vessel disease (CSV).   "
124303|NCT01658709|"     The objective of this study is to determine if a clinical measure can be used effectively to     predict ankle injury in high school and collegiate athletes across a variety of sports.      Hypothesis: For each ankle injury category (lateral ankle sprain, medial ankle sprain,     syndesmosis ankle sprain, Achilles rupture, fracture) participants that suffer these injuries     will have a significantly lower SEBT normalized composite score and FMS composite score     compared to those participants that do not suffer the injury      Hypothesis #1b: Similar to a previous study examining high school basketball players22, using     receiver operator characteristic (ROC) curves, we will be able to calculate likelihood     ratios, odds ratios, sensitivity and specificity and determine the ideal cut-off point of the     SEBT normalized composite score and FMS composite score that will be able to predict the risk     of each ankle injury category (lateral ankle sprain, medial ankle sprain, syndesmosis ankle     sprain, Achilles rupture, fracture).      Athletes from identified sites will perform measures of the star excursion balance test     (SEBT) and the Functional Movement Screen FMS before the first day of practice. During the     competition season, the number of practice and competition person exposures, as well as the     number of ankle injuries, will be recorded. The rate of ankle injuries/exposure will be     calculated and compared with the pre-season SEBT scores to create a simple and a complex     prediction model for risk of ankle injury   "
124304|NCT01658696|"     Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become     more widely available. However, transmission still persists and it appears that additional     control measures are required. The leading malaria vaccine candidate in development is RTS,S     which has efficacy against clinical malaria measured at 30-50% in the field. This partial     protection might be enhanced by combination with other components. The other vaccination     approach that has produced repeatable efficacy in humans is the use of viral vectors to     induce T cell responses. Previous attempts with this vaccine approach have been effective in     challenge studies in Oxford, but ineffective in the field, probably because of reduced     immunogenicity with previous vector platforms.      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity     by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified     vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with     thrombospondin- related adhesion protein (ME-TRAP).      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and     partial protection in 5 out of 14 volunteers in challenge studies.      The investigators propose a Phase 2b study of 120 healthy adult men in Senegal. The     investigators will assess the efficacy and further evaluate the immunogenicity and safety     profile of the vaccine regimen. The investigators also intend to assess the correlates of     efficacy and natural immunity.   "
124305|NCT01658683|"     The purpose of this study is to develop a new intervention to improve the transition of     patients from structured, supervised exercise to self-managed home- or approved     community-based exercise programs in an effort to increase maintenance of exercise behaviour     post cardiac rehabilitation (CR). The goal of the study is that those receiving the     intervention will engage in at least 30 minutes of physical activity at a moderate or     vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those in     the usual care group. The new intervention will be delivered by trained exercise facilitators     (physiotherapists or exercise specialists) and will make use of: small group counseling     teleconferences (5 sessions); personal telephone contacts (3 sessions), and community program     demonstrations that would facilitate linkages between patients and approved community     programs known as Heart Wise Exercise programs available in Ottawa and Toronto. The trial     will be conducted at the Minto Prevention and Rehabilitation Centre at the University of     Ottawa Heart Institute and the Cardiovascular Rehabilitation and Prevention Centre at the     University Health Network (Peter Munk Cardiac Centre [PMCC] and Toronto Rehabilitation     Institute [TRI]) sites. The study has a target enrollment of 604 participants.   "
124306|NCT01658670|"     The purpose of this study is to determine the efficacy of the Heart Failure Exercise and     Resistance Training (HEART) Camp behavioral exercise training intervention on long-term     adherence to exercise at 18 months in patients with heart failure. The central hypothesis is     that the HEART Camp intervention group (HC) will have significantly better adherence to     exercise at 18 months.   "
124307|NCT01658657|"     The purpose of this study is to investigate the effect of plasma renin activity-guided     therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that     can be measured to determine your hypertension subtype. Once the subtype is known, doctors     can prescribe specific medications to target your specific hypertension subtype. This study     will investigate whether targeting the specific hypertension subtype helps to achieve blood     pressure control sooner and with fewer medications compared to a standard fixed dose     combination therapy.   "
124308|NCT01658644|"     Communication is critical within healthcare, and is the root cause of most errors. With     increased adoption and use of new information technologies and mediated communication     systems, such as Electronic Health Records (EHR), that support visual content, hospitals can     begin to look at the potential of photographic aids to improve patient satisfaction,     clinician communication, and ultimately quality of care. Having pictures of clinicians and     patients may improve communication by improving knowledge of who is part of the care team and     may reduce electronic ordering or documentation on the wrong patient.      Despite the importance of communication between clinicians and the many advances within     information and communication technologies, there is a lack of literature documenting systems     that are effective at improving communication. Our research study will provide an overview on     the communication models and technologies used in Canadian hospitals and add insights to the     impacts of these technological adoption.      Research Question: How does the use of photographic influence patients' hospital experience?      Specifically, do photographic aids (photographs of clinicians' faces) influence:        1. Patient's ability to identify their clinical care team members        2. Patient's ability to identify their care team members and know their individual roles        3. Patient's satisfaction with their hospital experience   "
124309|NCT01658631|"     The purpose of this study is to compare the non invasive measurement of arterial pressure     (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)        -  during induction of general anesthesia,        -  during a leg raising test in the Intensive Care Unit   "
124310|NCT01658618|"     This observations safety study is intended for subject who participated in the 802-247-09-029     study with the investigational product HP802-247 for venous leg ulcers and received at least     one application of HP802-247 or Vehicle (an inactive substance). This study is being done for     the following purposes:        1. to identify new adverse events,        2. to examine ongoing adverse events not resolved in subjects who participated in the          802-247-09-029 trial,        3. to record wound status, and        4. to determine if there are differences in Health Related Quality of Life (HRQoL)          associated with the treatment assignment from the 802-247-09-029 Trial.      Investigational means that HP802-247 has not been approved by the U.S. Food and Drug     Administration (FDA).   "
124346|NCT01658124|"     Severe bleeding in the digestive system is a common symptom of many diseases. Each year,     about 50,000 people end up in British hospitals because of this problem and about 5,000 of     them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa,     schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach     bleeding each year. From previous research in other bleeding conditions such as surgery and     trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now     want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are     any complications in people with severe bleeding from the digestive system.   "
124311|NCT01658605|"     GSK1605786 is an oral antagonist specific for the chemokine receptor CCR9 in development for     treatment of small bowel and colonic Crohn's disease (CD). The purpose of this Phase II proof     of concept study is to investigate the efficacy and safety of GSK1605786 (500 mg twice daily)     administered orally for 16 weeks for the treatment of patients with active ulcerative colitis     (UC). A key secondary objective is to understand the mechanism by which GSK1605786 is acting     and to this end samples will be collected to confirm the degree of inhibition of CCR9 on T     lymphocytes in the blood of patients, and to explore the relationship between concentration     of drug and changes in lymphocyte and antigen presenting cell populations in the peripheral     circulation and in the colon. Patients recruited at specified investigational sites will be     invited to participate in an optional sub-study to explore the effects of GSK1605786 on     trafficking of technetium labelled T cells using Single Photon Emission Computerized     Tomography (SPECT). Specifically, the technique will be used to follow trafficking to large     intestine and thymus and findings linked to pharmacokinetics of GSK1605786, receptor     occupancy and clinical efficacy outcomes   "
124312|NCT01658592|"     The main objective of this study is to assess the efficacy of bilateral deep brain     stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule     (VC) as a novel treatment in severe alcohol addiction. The included patients have been     treated so far with drugs that inhibits alcohol, or psychological behavior training.      Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol     and thus enable the patients to decrease their alcohol intake substantially.   "
124313|NCT01658579|"     Primary Objective:        -  To compare the glucose control during treatment with a new formulation of insulin          glargine and Lantus in adult participants with type 1 diabetes mellitus      Secondary Objectives:        -  To compare a new formulation of insulin glargine and Lantus given in the morning or in          the evening        -  To compare the incidence and frequency of hypoglycemic episodes        -  To assess the safety and tolerability of the new formulation of insulin glargine   "
124314|NCT01658553|"     A multicenter, non-randomized, placebo-controlled, single dosing schedule, subject-blinded     study to evaluate the effect of GSK1120212 on the electrical activity of the heart as     compared to placebo in subjects with solid tumor cancers. All subjects will undergo Screening     assessments within 21 days prior to the start of the study treatment to determine their     eligibility for enrollment in the study. Eligible subjects will receive study treatment     administered over a period of 15 days followed by a post-treatment follow-up visit. Study     treatment (GSK1120212-matched placebo) will be blinded to subjects. Subjects will receive     GSK1120212-matched placebo on one day during the first 14 days of dosing. On all other days     the subject will receive a once-daily 2 mg dose of GSK1120212 except for Day 15 when the     subject will receive 3mg dose of GSK1120212 12-lead ECG recordings will be obtained from     continuous ECG recordings obtained via a 12-lead Holter monitor on Study Days 1 and 15 while     subjects are in the clinical research unit. The effect of GSK1120212 on the electrical     activity of the heart will be determined by time-matched ECGs obtained at the same time     points relative to dosing on these days. Ambulatory blood pressure readings will be obtained     from continuous 24-hour recordings via an ambulatory blood pressure monitor The effect of     GSK1120212 on blood pressure parameters will be determined by blood pressure readings     obtained at the same time points relative to dosing on Study Days 1 and 15. Serial blood     samples to analyze the concentration of study drug in the subject's blood will be obtained at     the same time points relative to dosing on Study Days 1 and 15. Subjects who are eligible for     continued treatment with GSK1120212 may continue treatment under the rollover study MEK114375     (drug study number). A post-treatment follow-up visit will be conducted within 28 days of the     last dose of study treatment for all subjects who do not continue treatment in the rollover     study MEK114375.   "
124315|NCT01658540|"     The primary purpose of this study is to assess safety and efficacy of the Drug Eluting     Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic     obstructive vascular disease in patients presenting with long lesions. As secondary aim this     study is going to explore treatment effect on a number of procedural and clinical endpoints     in order to collect information to design a future comparative effectiveness study.   "
124316|NCT01658527|"     The objective of this randomized phase II open label trial is to determine the anti-tumor     activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical     progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH     (luteinizing hormone-releasing hormone) agonists or surgical castration.   "
124317|NCT01658514|"     This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in     subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction,     or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In     addition, this study compared the behavior of a single dose of Met DR with that of     extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney     function described above.   "
124318|NCT01658501|"     Primary objective:      The primary objective of this study is to define the dose response of Glymera as measured as     the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.      Secondary objectives:      The secondary objectives are to:        -  Describe incidence, severity, and duration of reported gastrointestinal side effects of          Glymera compared to active comparator;        -  Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo          and active comparator;        -  Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of          dosing compared to placebo and active comparator;        -  Describe the frequencies of adverse events in the treatment groups; and        -  Describe the above endpoints for the following subgroups of subjects according to          baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin          only, sulfonylurea only, or metformin and sulfonylurea combination therapy.   "
124319|NCT01658488|"     The purpose of this study is to see if rice enriched in iron will help women with     iron-deficient anemia restore their blood counts more efficiently than the standard rice not     enriched with iron.   "
124320|NCT01658475|"     This study was performed to evaluate prospectively the diagnostic utility of a blood IgG     antibody titer test against periodontal pathogens.   "
124321|NCT01658462|"     National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy /     Second-line chemotherapy for locally recurrent or metastatic breast cancer.   "
124323|NCT01658436|"     This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC)     versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET)     after failure of mTOR inhibitor therapy.      Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single     arm, open label design and Stage 2 was planned to be a randomized, double-blind study.      However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.   "
124324|NCT01658423|"     The current study examined the effect of maturity on the sprint and jump performances in a     single year age group of 13 year old boys.   "
124325|NCT01658410|"     Background: Although selected cardiac surgery can be performed off-pump, the vast majority of     cardiac surgical procedures today are performed with the support of cardiopulmonary bypass     (CPB). Blood cardioplegia is used to protect the heart during aortic cross-clamping. However,     negative effects of myocardial hypoxia during surgery are often aggravated by     ischemia/reperfusion injury. In addition, cardiopulmonary bypass leads to an inflammatory     response including endothelial cell activation.      Comparable to the reperfusion injury following acute myocardial infarction resolved by     percutaneous coronary intervention, the microcirculatory impairment observed after cardiac     surgery may be caused by endothelin 1 (ET-1). ET-1 is a potent vasoconstrictor peptide     upregulated in myocardial ischemia-reperfusion injury. Short-term administration of the     selective ETA receptor blocker BQ-123 was found safe in a pilot study including patients with     acute myocardial infarction.      Hypothesis: Acute local ETA receptor blockade by intracoronary administered BQ-123 reduces     myocardial injury.      Methods: BQ-123 will be administered in patients undergoing on-pump aorto-coronary bypass     grafting to the left anterior descending coronary artery with the use a left inner mammary     artery graft and at least one vein graft. Subjects will be randomized to receive the     endothelin-A receptor blocker BQ-123 or placebo administered intracoronarily in combination     with cardioplegia in a double-blind manner. The primary endpoint will be enzymatic infarct     size.      Clinical perspective: The implementation of BQ-123 as an add-on pharmacologic therapy in     cardiac surgery performed with the use of cardiopulmonary bypass could lead to improved     tissue reperfusion and reduced ischemia/reperfusion injury, potentially impacting clinical     long-term outcome.   "
124326|NCT01658397|"     In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast)     on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in     bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure     subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will     increase after an acute fast.   "
124327|NCT01658384|"     This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis     (MS) patients. During a period of 24 months, the study will assess the evolution of cognitive     function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and the     CogState battery of tests.   "
124328|NCT01658371|"     Genetic polymorphism affects plasma concentration of antiretroviral therapy in HIV patients.     The investigators investigate the prevalence of genetic polymorphism affecting efavirenz     metabolism and the corresponding pharmacokinetics of different genotypes.   "
124329|NCT01658358|"     Objectives:      Phase I part        -  Primary Objective: To determine the recommended dose of the combination of lapatinib          with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic          breast cancer.        -  Secondary Objectives:To define the safety profile; To observe the response rate and          progression free survival      Phase II part        -  Primary Objective :To determined the objective response rate of the combination of          lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive          metastatic breast cancer.        -  Secondary Objectives:To define the safety profile; To determined the progression free          survival   "
124330|NCT01658345|"     Aortic stenosis (AS), or narrowing of the aortic valve, is the commonest condition requiring     valve surgery in the developed world. It is currently not known what determines who will go     on to develop symptoms. Exercise testing may be able to identify these patients better than     the severity of the narrowing itself, but with some limitations.      The purpose of this study is to compare whether MRI scanning or exercise testing can better     identify patients with AS who are likely to benefit from surgery.      Design: The investigators will measure blood flow to the heart muscle with MRI scanning and     perform exercise testing in 170 patients with AS and follow them for up to up to 2 years.     Expected outcomes: MRI scanning will more accurately identify those patients with AS who will     need surgery during this period. Anticipated Health Benefits: improved selection of patients     with AS who are likely to benefit from early surgery. This is likely to reduce deaths in such     patients.   "
124331|NCT01658332|"     TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer     (CIRCUBRONCH)      BACKGROUND : Circulating tumor cells identification is a new field of research in oncology,     and some studies have been conducted with success on breast and prostate cancer. Nearly 80%     of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells     identification and monitoring these cells after treatment could help the clinicians to detect     relapse or be a prognostic factor.      PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage     lung cancers (IIIB and IV).      SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the     therapeutic response. Prognostic value of identification of circulating tumor cells at the     time of diagnosis.      STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification     of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.      Duration of the inclusions: 54 months.      Duration of the study: 66 months.      PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a     cut-off of 5 cells/7,5 ml of blood.      SAMPLE SIZE : 200 patients      STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage     IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating     tumor cells per 7,5 ml of blood.   "
124332|NCT01658319|"     This phase I trial is studying the side effects and best dose of methoxyamine when given     together with fludarabine phosphate in treating patients with relapsed or refractory     hematologic malignancies. Drugs used in chemotherapy, such as methoxyamine and fludarabine     phosphate, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Giving methoxyamine together with fludarabine     phosphate may kill more cancer cells.   "
124334|NCT01658293|"     Sensory and/or motor deficits in upper limb following stroke often have negative impacts on     their daily living. Thermal stimulation with hot and cold pack alternatively incorporated     into conventional rehabilitation has been reported and proved to be effective for upper limb     functional recovery after stroke. However, whether hot- and cold-water stimulation     alternatively based on thermal stimulation also has the effect still remains unknown. The aim     of present study is to investigate the facilitated effect of hot and cold water stimulation     alternatively on upper limb after stroke.   "
124337|NCT01658254|"     The gap between the high number of registered trials and the few ones where results were     available (in registries or in journals) has been identified as a major problem distorting     the scientific evidence available. As a consequence, the FDAAA (Food and Drug Administration     Amendments Act) added on September 27, 2007 a requirements policy regarding publication of     summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary     results is required for applicable clinical trials no later than one year after the     primary completion date, i.e. the date of collection of primary outcome data on the last     patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to     designate trials that may be subject to the registration and reporting requirements.      Not complying with the reporting requirements can result in penalties, such as withholding of     National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a     day. Despite the possibility of incurring penalties for not complying with the posting     requirement, compliance remains globally poor.      In this current study, the primary objective will be to test the hypothesis that sending an     email looking as a survey, reminding the necessity of posting results to the trials'     responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but     not complying with it, will increase the results posting rate.   "
124338|NCT01658241|"     This study is looking at the effects of Panobinostat, an investigational treatment, on cancer     cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific     Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T     lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune system with     too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune system with too     many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells).      Panobinostat is a new drug which has led to disease improvement in some patients with Hodgkin     lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not all     patients benefit from panobinostat.      The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this     project is find out which patients or diseases are likely to respond to treatment with     panobinostat in the future and to see if there are particular features of the patient or of     the cancer that affects the likelihood of the way individuals respond to panobinostat.      Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in     normal cells make proteins. Panobinostat has been used in several clinical trials around the     world. The largest trials generally have fewer than 200 patients and are in Hodgkin lymphoma,     cutaneous T-cell lymphoma, and myeloma where between one in five and one in three patients     have significant improvement in their disease.      Researchers will look at samples of tumour before treatment and during treatment. This will     be one of the first studies to look at how cancer cells change following treatment with this     drug. It is unusual because it requires repeated biopsies of the participant's tumour.     Panobinostat is considered an experimental (or investigational) drug and not approved by any     regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the     Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer.     Therefore, Panobinostat is not approved to treat patients who have been diagnosed with     refractory or relapsed cancer.      A total of 30 patients with one of the diseases listed above will be enrolled at Peter     MacCallum Cancer Centre.      It is expected it will take about 2 to 3 years to recruit 30 patients and that on average     patients will take part for six to eighteen months. This time could be shorter or longer     depending on how well the treatment works in each individual. While the trial will take up to     4 years to complete, the science studies may take longer.   "
124339|NCT01658228|"     Patients presenting with depression (DEP) and cognitive impairment (CI), represent a unique,     understudied population that is difficult to diagnose, treat and estimate prognosis. Our     pilot data, supported by the literature, suggest that many DEP-CI patients show cognitive     decline and often convert to dementia, primarily Alzheimer's disease (AD). In DEP-CI, there     is a lack of data on treatment response of mood symptoms to antidepressant treatment and     particularly of cognitive deficits to cognitive enhancer treatment. Our initial pilot data in     a double-blind study showed that donepezil was superior to placebo in improving memory in     antidepressant-treated DEP-CI patients. In a second pilot study, open label es-citalopram     plus memantine treatment led to a low rate of conversion to dementia.      In this proposed pilot clinical trial, the investigators will evaluate, treat and follow a     broad sample of 80 DEP-CI patients at NYSPI/Columbia University Medical Center (N = 40) and     Duke University Medical Center (N = 40). Recruitment will be from clinics and/or     advertisements. In the treatment protocol, all 80 DEP-CI patients will receive baseline mood     and memory assessments and open antidepressant treatment with citalopram for 8 weeks. At 8     weeks, repeat assessment will occur and patients whose depression has responded to citalopram     will be randomized to add-on donepezil or placebo. Non-responders to citalopram will receive     open treatment with venlafaxine and will be randomized 8 weeks later (16 weeks of open     antidepressant treatment) to add-on donepezil or placebo. Patients will be followed for a     total period of 18 months with continuous open antidepressant treatment during the trial.      Donepezil is being studied in order to increase the likelihood of obtaining a signal. If the     results are positive, the investigators can begin clarifying the mechanism(s) in subsequent     trials. Baseline apolipoprotein E e4 genotype, odor identification deficits, and MRI     hippocampal and entorhinal cortex atrophy will be explored as predictors of donepezil     response in the 18-month trial. Improving cognition and delaying conversion to a clinical     diagnosis of dementia in this high risk group will enhance quality of life, reduce family     burden, and markedly diminish overall health care costs.   "
124340|NCT01658215|"     The purpose of this study is to compare the relative bioavailability of nicotine following     repeated applications of a new transdermal formulation to that of a reference formulation.      Up to day 7   "
124341|NCT01658202|"     The purpose of this study is to compare the relative bioavailability of nicotine following     single application of a new transdermal formulation to that of a reference formulation.      4 single 24hour applications separated by 48hour intervals.   "
124342|NCT01658176|"     PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor for     the treatment of advanced breast cancer in women whose disease has progressed following     tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance to     hormonal therapy and result in greater clinical benefit than exemestane alone in women with     estrogen receptor positive advanced breast cancer.   "
124343|NCT01658163|"     The investigators prospectively studied the results of wound closure after abdominoplasty     with randomized use of PrineoTM and conventional suturing to assess the possible difference     in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled     at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three plastic     surgeons and three plastic surgery residents assessed the wound and scar appearance during     the three follow-up visits.   "
124344|NCT01658150|"     The purpose of this study is to evaluate the use of the drug isradipine for cognitive     enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.   "
124345|NCT01658137|"     Genetic factors contribute to risk factors for cardiovascular disease, such as blood lipids,     blood pressure, obesity, diabetes, and may also influence dietary choices, physical activity,     and responses to stress. The most robust genetic variant associated with myocardial     infarction (MI) is the 9p21 variant, which may raise the risk of MI by up to 40% in those who     carry 2 copies of the gene. The investigators recently found that among those who carry the     9p21 variant, the risk of MI may be turned off if individuals eat a diet high in fruits and     vegetables. The investigators seek to determine how a prudent or anti-inflammatory diet     interacts with the 9p21 risk allele to alter the risk of MI.   "
124356|NCT01657994|"     The purpose of this research study is to learn more about the usefulness of a physical     therapy treatment that combines robot-assisted walking with electrical impulses that help to     make muscles contract. This treatment is intended for children with cerebral palsy. Up to     eleven children with cerebral palsy will receive up to 18 treatments and will have several     evaluations before and after treatment.   "
124347|NCT01658111|"     Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions     on conditions leading to long-term disability, such as stroke, is a complex task because the     outcome depends on many interacting factors. Several studies underline the importance of     brain plasticity and its therapeutic potential in neurological disorders. Accredited theories     of cortical reorganization after brain lesion endorse the use of early, intensive,     repetitive, and context-related exercise as optimal strategies to promote motor relearning     and minimize motor deficit. The use of robotic systems in upper limb motor rehabilitation     programs has been already demonstrated to provide safe and intensive treatment to subjects     with motor impairments due to a neurological injury: several studies showed the advantages of     robotic therapy on chronic post-stroke patients, even if no consistent influence on     functional abilities was found and evidence of better results providing intensive treatments,     both robotic and conventional rehabilitative techniques, was found. Recent development and     recent trial in robot-assisted rehabilitation has shown the great potential of robotic     devices for delivering repetitive training, thus facilitating a high intensity and a large     dose of training during sub-acute and chronic phases of stroke rehabilitation. The proposed     project, through a randomized controlled observer-blind multicenter trial is aimed at     evaluating the effectiveness of robot-assisted therapy as additional treatment to the     standard physical therapy in the early phase after stroke onset and evaluating in conjunction     with EEG and EMG recordings the effects of the rehabilitative treatments in a quantitative,     measurable way, by providing reliable and objective methods for measuring functional recovery     after stroke.   "
124348|NCT01658098|"     This research will use the Edinburgh Scale Of Post partum depression to evaluate patients     during their 4th to 6th after delivery, and the investigators will compare the results with     those found in other countries with population with similar characteristics as ours   "
124349|NCT01658085|"     Study Design Multinodular Goiter (MNG) patients requiring surgery were referred to the     Endocrine Surgery Unit.      Indirect laryngoscopy was routinely performed preoperatively to assess normal motility in     vocal folds (VF). Ultrasounds (US) study was performed the month previous to surgery to     evaluate thyroid volume. Eligible patients met the following criteria: to have MNG, age     between 18 and 80 and consent to be included in the study. Exclusion criteria included     previous neck surgery, vocal fold impairment, permanent or transitory NSAID or analgesic     treatment, coagulation disorders and any cognitive impairment.      Eligible patients were proposed to enter a randomized study with 2 arms in which we compared     the use of two harmonic scalpel devices: ACE14S and Harmonic Focus (Ethicon Endo-Surgery,     Cincinnati, OH, USA).      The main endpoint was operative time. Secondary endpoints were total and relative (%) time of     use of the device along thyroidectomy, recurrent laryngeal nerve (RLN) injury and     hypocalcaemia (both persistent or temporary), number of ligatures, length of skin incision,     postoperative pain according to a visual scale of pain, QOL after thyroidectomy (EuroQOL) and     budget impact analysis.      All patients were operated on by 2 surgeons, one senior (responsible for the Endocrine     Surgery Unit) and one junior under supervision.      Randomization Randomization was performed the same day of surgery at the OR by using a closed     envelope. Patients were randomized to Group I (ACE14S) or Group II (HF) and allocated in a     1:1 proportion; they reminded blinded until the end of the study about the device used.      The haemostasis device was communicated to the surgeon previous to start surgery. Medical     staff of the Endocrine Surgery Unit collected clinical data.      Surgical Technique Total thyroidectomy (TT), defined as total bilateral extracapsular     lobectomy 9, was performed using HF or ACE14S for vessel division. Monopolar and bipolar     forceps for cutting and coagulation were routinely used. Ties were used under surgeon's     criteria according to size of the vessels and/or the need to obtain haemostasis in the     vicinity of the RLN when bipolar forceps were not considered safe enough.   "
124350|NCT01658072|"     The best way to provide analgesia after total hip arthroplasty is hotly debated. There are     two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their     proponents, but there are limited data for making an informed choice of protocols. For total     hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with     physical therapy. However, epidural analgesia can be associated with nausea, pruritis,     dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may     prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided     to use a different analgesic protocol, based on a peri-articular injection. This protocol     avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as     part of a multimodal pain therapy. The investigators propose to compare peri-articular     injection to epidural patient controlled analgesia (Epidural PCA). The investigators will     enroll 90 total patients (45 per study arm). The enrollment period will be approximately one     year and the duration of the follow-up with study patients will be three months following     their procedure.   "
124351|NCT01658059|"     Pharmacological interventions to aid behavior management's techniques are commonly used in     pediatric dentistry. The aim of the medicaments is to control behavior and allow safe     completion of a dental procedure. Homeopathic remedy is safe and can be effective to control     behavior and decrease anxiety in children during dental treatment.      Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety     before dental treatment.      2. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for     anxious children.      Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will     receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be     measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS),     and Houpt behavior scale.      Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation     during dental treatment.   "
124352|NCT01658046|"     Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in     chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized     controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus     quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training     (control group) on muscle function, exercise capacity, health related quality of life,     activities of daily living, and self-efficacy in patients with COPD who are eligible and able     to participate in endurance training.   "
124353|NCT01658033|"     The objective of this phase II study is to evaluate efficacy and safety of avastin plus     modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five     patients will be enrolled into this study.   "
124354|NCT01658020|"     The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple     dose of Zabofloxacin Tablet 400 mg.   "
124355|NCT01658007|"     The investigators want to learn about treating relapsed/refractory lymphoblastic leukemia and     lymphoma with a drug called sirolimus. The investigators are using sirolimus along with other     cancer drugs that are often given to patients with relapsed leukemia and lymphoma.      The main purpose of this study is to determine if sirolimus can be given safely in     combination with standard drugs used to treat relapsed lymphoblastic leukemia/lymphoma.   "
124358|NCT01657968|"     The primary purpose of the present study is to investigate the usefulness of Procalcitonin as     a supplement to the Streptococcal antigen test and Centor criteria in the differential     diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.      Furthermore, the investigators aim to examine Procalcitonin as a diagnostic marker in acute     tonsillitis due to Fusobacterium Necrophorum.   "
124359|NCT01657955|"     The purpose of this study is to determine whether bendamustine is effective in the treatment     of initial treatment of Chronic Lymphocytic Leukemia (CLL).   "
124361|NCT01657929|"     The purpose of this study is to determine the safety, tolerability, and immunogenicity in     healthy adult subjects of an investigational vaccine being developed for the prevention of     pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant     influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based     expression system assembling into virus-like particles together with the adjuvant GLA-AF.   "
124362|NCT01657916|"     Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align     Urethral Support System.   "
124363|NCT01657903|"     The purpose of this study is to compare and evaluate the ability of two European Union (EU)     regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a     modified in-situ model of dental erosion and remineralization. A positive control i.e     fluoride containing toothpaste marketed in EU will also be compared to non-fluoride     toothpaste.   "
124364|NCT01657890|"     The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy     non-elderly and elderly male and female subjects.   "
124365|NCT01657877|"     In situ study to compare treatment effect on enamel remineralization potential, measured by     surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will     explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice     containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only     dentifrice.   "
124366|NCT01657864|"     The objective of the study is to quantify the number of cases of aseptic meningitis among     users of Lamotrigine. This study is a cross-sectional study design using data on lamotrigine     patients within the Thomson Reuters MarketScan® Commercial database (MarketScan database).     The MarketScan database is a US-based insurance claims database representative of a US     insured population and includes supplemental datao n Medicare patients. This cross-sectional     study will evaluate the number of cases of aseptic meningitis among lamotrigine users during     the duration of lamotrigine therapy, with an extended exposure window of 30 days after     completing therapy.      The MarketScan® Database is an US insurance claims database that is held in-house at GSK,     which can be interrogated to examine rates of prescribing and medical conditions that can be     captured via ICD-9 diagnoses codes. The MarketScan database captures person-specific clinical     utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug,     and carve-out services from a selection of large employers, health plans, and government and     public organizations. The annual medical databases include private sector health data from     approximately 100 payers. In 2011, there were approximately 35 million patients on the     database. The Commercial Claims and Encounters Database represents the medical experience of     insured employees and their dependents for active employees, early retirees, COBRA continues,     and their dependents insured by employer-sponsored plans (i.e., non-Medicare eligibles). In     addition, a linked Medstat Medicare database contains predominantly fee-for-service plan data     in insurance plans where both the Medicare-paid amounts and the employer-paid amounts were     available and evident on the claims.The data are HIPAA compliant thus all patients have been     anonymized.   "
124367|NCT01657851|"     Open-label, randomized, single dose, two-treatment, two-way crossover study   "
124368|NCT01657838|"     The purpose of this study is to assess the effect of ketoconazole at steady state on the     pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.   "
124369|NCT01657825|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics (PK) of warfarin after single dose administration.   "
124388|NCT01657578|"     The principal aim of this trial is to determine the minimum effective dose of omeprazole in     neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry),     to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after     initiation of omeprazole.      The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon     other pHmetry parameters, (2) to characterize the population pharmacokinetics and     pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal     pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates.   "
124370|NCT01657812|"     Clinically, combining epidural with general anaesthesia may confer many advantages to     patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia     can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis,     spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However,     establishing epidural anesthesia is not without risks and contraindications, including     refusal by the patient, technical failure, unintentional dural puncture, waist and back pain     and local anaesthetic toxicity. When neurologic complications do occur, the resulting     morbidity and mortality is considerable. Dexmedetomidine is a potent α2-adrenoceptor agonist     with an 8 times greater affinity for α2-adrenoceptors than clonidine. This class of agent is     known to have sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing     effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate     the stress response associated with surgery.1 Unlike epidural anaesthesia, dexmedetomidine is     easy to administer and no potential for neurological damage. The investigators hypothesize     that the dexmedetomidine reduces the stress response of surgery to the similar extent to     epidural anaesthesia when used in conjunction with a standard general anaesthesia for     abdominal surgery.   "
124371|NCT01657799|"     The primary objective of this study is to evaluate the Overall Survival, Best Tumor Response     Rate, Time to Intracranial Progression (radiographic), Time to Clinical Brain Metastasis     Progression, safety, and tolerability of veliparib and Whole Brain Radiation Therapy in     subjects with brain metastases from Non Small Cell Lung Cancer   "
124372|NCT01657786|"     Postoperative nausea and vomiting (PONV) is a common and distressing complication in patients     undergoing general anesthesia. However, although 5-hydroxytryptamine type 3 (5-HT3) receptor     antagonists have significantly reduced PONV, it is reported that over 35% of patients treated     with ondansetron experience PONV. Though the cause of failure in ondansetron treatment is not     clear, the investigators assumed that polymorphism in the 5-HT3 receptor gene would     contribute to such inter-individual variation. In this study, the investigators examine     whether the polymorphisms of 5-HT3 receptor gene affect the efficacy of ondansetron to     prevent PONV in patients undergoing general anesthesia for laparoscopic surgery.   "
124374|NCT01657760|"     Alcohol use disorders (AUDs) are highly prevalent among U.S. civilians, and even more     prevalent in the U.S. Veteran population. AUDs are frequently co-morbid with depressive     symptoms in psychiatric clinical populations, resulting in an increased severity of both     conditions. Indeed, returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)     Veterans have extraordinarily high rates of alcohol misuse and co-morbid psychiatric     symptoms, indicating that future Veteran clinical populations will be particularly affected     by AUDs. While FDA-approved medications are available to treat AUDs, their efficacy is low     compared to available psychosocial treatments. Despite the lack of evidence for efficacy from     controlled trials, antidepressants are frequently prescribed to clinical populations     (including Veterans) with active AUDs. A better understanding of patient-level clinical     variables that may confer poor response to treatment with antidepressants would allow     clinicians better tools to distinguish those alcohol-dependent Veterans likely to do worse     with antidepressant treatment.   "
124375|NCT01657747|"     The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a     non-invasive method for        -  accurate staging of patient suspected having ovarian cancer        -  early treatment assessment        -  detecting tumor recurrence   "
124376|NCT01657734|"     Malignant gliomas are aggressive tumours with poor prognosis despite the current multimodal     treatment. Hence, there is a clear need for new, effective therapies, among which immune     therapy has emerged as a promising treatment option.      When interpreting follow-up magnetic resonance (MR) examinations, the radiologist is often     confronted with images that are difficult to interpret with the conventional anatomical     imaging techniques. The difference between tumour relapse and therapy-mediated changes is not     always distinctive.      In this project, the investigators attempt to characterize the inflammatory response with     parameters from advanced MRI techniques like MR spectroscopy, MR perfusion imaging and     MR-diffusion imaging. These techniques allow characterization of cellular properties like     metabolism and tissue structure respectively. Doing so, the investigators will monitor     disease evolution in order to timely detect treatment failure, thereby allowing appropriate     switch in patient management.   "
124377|NCT01657721|"     The overall objective of the current study is to determine whether computerized Working     Memory (WM) training will enhance WM capacity in college students with Attention Deficit     Hyperactivity Disorder (ADHD). There are also four additional objectives. The first is to     investigate whether the program's efficacy is impacted by the duration of the daily training     sessions. The second is to determine whether improvements in WM will generalize to secondary     outcome tasks, such as inhibitory control and planning. The third objective is to examine     whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The     last objective is to investigate whether improvements will be maintained at a two month     follow-up period. The investigators will also be assessing healthy control participants,who     will not be receiving treatment, but will be used as a basis of comparison with the ADHD     participants,      It is expected that the computerized WM training program will enhance WM capacity in college     students with ADHD. In addition, it is believed that these increases in WM capacity will also     lead to improvements in other executive functions. It is also hypothesized that WM training     will lead to a reduction in ADHD symptomology. Lastly, these improvements should be     maintained at three month follow-up.   "
124389|NCT01657565|"     Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic     appendectomy (LA). The investigators wanted to elucidate the outcome of childhood     appendicitis treated primarily by residents in a university hospital.      Material and methods: All children (age<16 years) treated surgically with appendectomy in our     department between January 2006 and January 2011 were retrospectively identified.     Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were     considered as non-satisfactory outcomes.   "
138750|NCT01468597|"     The aim of the study is to evaluate if there is an association between platelet inhibition     and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual     antiplatelet therapy.   "
124378|NCT01657708|"     Background:      Shared Decision Making (SDM) refers to a process of health care delivery in which     practitioners and clients seeking help with decisions, collaborate to access relevant     information and enable client-centered selections of health care resources (1, 2). SDM leads     to better treatment adherence and outcomes for people with a medical problem (3). SDM     principles have previously been used in psychiatry to improve antipsychotic and     antidepressant medication adherence (4, 5); however, these principles have yet to be applied     to psychiatric rehabilitation (6).      The current research uniquely aims to test the development and implementation of a SDM     intervention for people with psychotic spectrum disorders (e.g., schizophrenia and affective     disorder) during the referral process to psychiatric rehabilitation services. The study will     be conducted this year using a randomly selected sample from the population of people with     psychotic spectrum disorders hospitalized in SHALVATA psychiatric hospital in Israel. It aims     to facilitate better treatment and rehabilitation outcomes. It has received the support and     approval of the Mental Health Division of the Ministry of Health (MOH) in Israel, the     institutional review board (IRB) by the university of Haifa, Israel and a Helsinki committee     approval by SHALVATA psychiatric hospital and the MOH in Israel.      References        1. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: What does          it mean?(or it takes at least two to tango). Soc Sci Med. 1997;44(5):681-92.        2. Adams JR, Drake RE. Shared decision-making and evidence-based practice. Community Ment          Health J. 2006;42(1):87-105.        3. Joosten EAG, DeFuentes-Merillas L, De Weert GH, Sensky T, Van Der Staak, C. P. F., De          Jong, C. A. J. Systematic review of the effects of shared decision-making on patient          satisfaction, treatment adherence and health status. Psychother Psychosom.          2008;77(4):219-26.        4. Hamann J, Cohen R, Leucht S, Busch R, Kissling W. Do patients with schizophrenia wish to          be involved in decisions about their medical treatment? Am J Psychiatry.          2005;162(12):2382.        5. Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, et al. Shared decision making          for in-patients with schizophrenia. Acta Psychiatr Scand. 2006;114(4):265-73.        6. Drake RE, Deegan PE, Rapp C. The promise of shared decision making in mental health.          Psychiatr Rehabil J. 2010;34(1):7-13.   "
124379|NCT01657695|"     Our long-term objective is to develop a new tool based on a (molecular-biology) integrated     imaging technology able to characterize and categorize hepatocellular carcinoma (HCC)     patients in need of liver transplant (LT). To this end, our study aims at correlating     specific imaging traits and fractional growth of individual tumors collected over a     restricted time frame (T0 and at week 7 after first tumor detection), with a molecular     signature, obtained by custom microarray, histochemical and cytokine analysis. This should     allow us to translate a series of purely morphologic information into a meaningful     pathobiologic data sets. Validation of the integrated molecular-imaging tool will be     performed prospectively by correlating the imaging-molecular data with HCC outcome in term of     survival and disease-free survival after down staging procedures.   "
124381|NCT01657669|"     This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection     administered in subject who have active choroidal neovascularization due to Age Related     Macular Degeneration (AMD).   "
124383|NCT01657643|"     The main purpose of the study is to find out if probiotics (healthy bacteria found in yogurt)     can improve the health-related quality of life (HRQL) during upper respiratory infections     (like the common cold) in college students living in residence hall on-campus at Framingham     State University (Framingham, MA) who are randomized to receive a probiotic or placebo candy     daily for 12 weeks. HRQL is a subjective measure, defined as the aspects of quality of life     (i.e., one's satisfaction with their life) that related specifically to a person's health     (for example, ability to carry out normal daily activities). The investigators hypothesize     that HRQL during URIs will be significantly higher in the probiotic groups compared to the     placebo group. The proposed study will also seek to address the following secondary     objectives: missed school and work days due to a upper respiratory infection.   "
124384|NCT01657630|"     This is an open, prospective, descriptive study aiming to evaluate the change in treatment     satisfaction of primary care givers of young children who use the Accu-Chek Combo System.     Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System     on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment     Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a     distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes     related therapeutic information will be collected and data about the use of the device     components will be downloaded from the Accu-Chek Combo System   "
124385|NCT01657617|"     It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a     significant problem. Conventional radiation therapy techniques have limitations for the dose     that can be delivered to a chest tumor mass due to the adjacent dose limiting organs.     Mounting evidence supports the use of hypofractionated stereotactically delivered radiation     therapy to control lung cancer with acceptable toxicity profiles.      Thus the investigators propose to increase the doses of radiation to residual masses of NSCL     to a BED > 100 Gy by the addition of two fractions of stereotactically delivered boost     radiation therapy to residual disease post-conventional chemoradiation to at least 59.4 Gy in     180 cGy fractions. Using the linear quadratic equation to model doses of radiation therapy,     59.4 Gy would have a BED of approximately 70 Gy. Single fraction stereotactic body radiation     therapy (SBRT) of 10 Gy would have a BED of approximately 20 Gy. Thus the addition of two     fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically     result in higher degrees of local control of lung cancer masses, achieving a minimum     cumulative BED of approximately 110Gy-equivalent.   "
124386|NCT01657604|"     Advances in Chronic Myeloid Leukemia (CML) therapy led to an expected survival prolongation     of > 20 years after diagnosis. So far, discontinuation of tyrosine kinase inhibitors led to     recurrence of disease in the majority of patients. The trial aims to improve treatment     strategies in CML by improving induction therapy and deescalating maintenance therapy using     low dose IFN as inducer of immunosurveillance. The trial will provide important data on the     duration of active therapy in CML patients. Considering the rapidly increasing prevalence of     CML this is of individual but also socioeconomic importance.   "
124387|NCT01657591|"     This is a multi-cohort, dose-escalation study of XL888 with a fixed dose of vemurafenib. New     dose escalation or de-escalation cohorts will be assigned by the Principal Investigator (PI)     with discussion with appropriate co-investigators once safety and tolerability is known for a     given cohort in accordance to dose escalation rules. Participants will be defined to be     enrolled within a cohort upon receipt of first dose of XL888/vemurafenib.   "
124390|NCT01657552|"     The purpose of the current Phase I, open-label, three-period, single sequence, crossover     study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag     (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this     study there will be a screening visit, three treatment periods, and a follow-up visit. In     Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK)     sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with     PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP     on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit     within 10 to 14 days of the last dose of study drugs. The total duration of the study from     Screening to Follow-up will be approximately 9 weeks.   "
124391|NCT01657539|"     Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp.     lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms     of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment.     Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be     performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the     volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt     which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4     weeks, respectively. Experimental samples of saliva and biofilm will be collected from each     participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric     microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values     before and after the treatment will be compared with Wilcoxon's test (p<0.05).   "
124392|NCT01657526|"     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK     Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.   "
124393|NCT01657513|"     TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are     well-tolerated with few side effects.      Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some     do not respond at all while others respond initially but gradually lose effect despite     increased dose and more frequent administration.      The cause of treatment failure is largely unknown and it may be production of tnf-alfa     neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and     inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.   "
124394|NCT01657500|"     The purpose of this study is to compare the success of storing a donor cornea in Optisol GS,     the current standard vs. storing the donor cornea in Life4°C, a newer solution. The donor     cornea to be used for EK will be provided by an eye bank and will have been stored in either     an Optisol GS solution or a Life 4°C solution. At 6 months, the doctors will determine     whether there are any comparable differences in cell loss and graft clarity between the two     donor corneas.   "
124397|NCT01657461|"     The primary study objective is to determine if subjects experiencing an acute ischemic stroke     due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization     Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS)     than those subjects treated with IV t-PA alone   "
124398|NCT01657448|"     The purpose of this study is to evaluate the efficacy of the combination of Methenamine +     Methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic     relief of dysuria.   "
124399|NCT01657435|"     This study is intended to gather medium (0-5 years) and long-term (6-10 years) information     regarding the performance and safety of the commercially available Ceramax™ Ceramic on     Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase     and a clinical outcomes phase.      In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered     for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective     evaluations and radiographs will be completed annually.      In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey     will be mailed to subjects annually.   "
124400|NCT01657422|"     PACE+ was developed to address the increased number of adolescents in our country that are at     risk for cardiovascular disease, cancer, and other diseases due to inactivity, obesity, and     malnourishment. PACE+ will evaluate the efficacy of an integrated clinical and home-based     intervention to improve physical activity and nutrition behaviors in adolescents ages 11-15     over a period of 2 years.      This study is unique in that it will be one of the first to evaluate a combined physical     activity and nutrition intervention for youth that revolves around the primary health care     setting. The PACE+ intervention is particularly innovative in that three components -     computer, provider counseling, and an extended home-based intervention - are unified through     a common theoretical framework.   "
124401|NCT01657409|"     Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or     without urge urinary incontinence (UUI) that may affect the patients' quality of life.     Current medical treatments are usually unsuccessful in completely eradicating urgency     sensation. Intra-detrusor injection of botulinum toxin A (BoNT-A) modulates the release of     neurotransmitters from sensory nerve endings and effectively modulates the inflammatory     process mediated by nociceptive afferent nerve dysfunction. Satisfactory clinical results     were achieved with intravesical BoNT-A injection, which increased bladder capacity and     decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity     (NDO, IDO). Excellent results were achieved with injection of either 100 U or 200 U of     BoNT-A. Episodes of frequency, urgency, and UUI were reduced, maximal cystometric capacity     increased, maximal detrusor pressure (Pdet) decreased, and the quality of life index also     improved significantly. However, post void residual (PVR) volume increased significantly and     some patients required clean intermittent catheterization (CIC) to evacuate the PVR.     Dose-related adverse events (AE) increased with increasing dose of BoNT-A. Therefore,     adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help     to maintain success rates.   "
124402|NCT01657396|"     The primary objective of this study is to evaluate the effectiveness and feasibility of the     implementation of revised standards of care for oral hygiene (SAGE Q-care q2 Oral Cleansing     and Suctioning System with and without chlorhexidine gluconate) relative to the current     routine standard of care in mechanically ventilated patients admitted to the adult Intensive     Care Units in Alberta Health Services Calgary Zone. This pilot study will evaluate the     feasibility of performing a larger definitive study. The primary assessment of effectiveness     for the definitive study will be the proportion of patients who develop ventilator-associated     pneumonia.   "
124403|NCT01657383|"     The collection of data regarding patient outcomes after surgical intervention creates     imperative knowledge to include surgeon performance, cost analysis, base for surgical     research and publication, which in turn assist surgeons to improve the standard of care     utilizing evidence-based practice.   "
124404|NCT01657370|"     The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the treatment     of acute migraine, including the influence of demographic and other variables on MK-1602     pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and     efficacy of the drug.   "
124405|NCT01657357|"     Follow up study of patients, who despite periacetabular osteotomy, need a total hip     arthroplasty, to see outcome.   "
124406|NCT01657344|"     The objectives of this study are to: develop an emergency care visit registry for pediatric     patients for Quality Improvement purposes and to support future research; to use the     emergency care visit registry to collect stakeholder-prioritized emergency care performance     improvement measures for important pediatric medical and trauma conditions at the level of     the Emergency Department (ED) and individual clinical; and report emergency care performance     improvement measures to individual ED clinicians and sites, and measure subsequent changes in     quality performance. The hypothesis is that by providing this type of information to     individual clinicians will result in improved performance and decreased variability     (variation) of care for an individual clinician, between different clinicians, and eventually     between hospital sites.   "
124407|NCT01657331|"     This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab     vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or     Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial     treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at     two subsites in Canada.   "
124408|NCT01657318|"     In this study, the investigators hypothesize that the use of olivamine-containing products in     the management of patients with compromised nonhealing lower extremity ulcers is feasible in     the Philippine setting. It will result in complete ulcer healing or wound closure after 16     weeks.   "
124409|NCT01657305|"     The main purpose of this phase III clinical trial is to show safety and efficacy of     Oleogel-S10 in the acceleration of Split-Thickness Skin Graft Donor Sites.   "
124410|NCT01657292|"     The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10     in the acceleration of wound healing of grade 2a burn wounds.   "
124453|NCT01656733|"     This is a clinical trial to determine if the nicotine inhaler in combination with counseling     will help pregnant women quit smoking, and whether it is safe when compared to placebo (an     inactive inhaler).   "
124411|NCT01657279|"     Background: Several risk score models are now available to assist clinicians estimate     outcomes after an acute ischemic stroke. Limited information is available on the predictive     value of these scores compared to real outcomes and clinical judgment.      Objectives: To compare clinician judgment with the use of a validated stroke risk score     (iScore) and patients' outcomes.   "
124412|NCT01657266|"     The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution     PRO-155 in patients post phacoemulsification.   "
124413|NCT01657253|"     The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution     PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with     ophthalmic solution Systane®   "
124414|NCT01657240|"     The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution     PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic     conjunctivitis.   "
124415|NCT01657227|"     Objective:        -  To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by          influencing disease self-management through lifestyle modification and by helping          primary care professionals to improve health care provided to patients.        -  To assess the effectiveness and cost-effectiveness of two complex interventions          (education and behavioural modification, independently and conjointly, for primary          health care teams (PHCT) and patients and their relatives) to improve the health results          in people with T2DM.      Methodology:      Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands.     Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures:     HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm.     Intervention: G1: Interventions on the patients: Educational and habit modification group     program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge     about the disease and their abilities; b) Computer-based clinical decision support system; c)     Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group.     Patients receive only the usual care.   "
124416|NCT01657214|"     Primary Objective:      In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.      In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in     patients with measurable and MET gene amplification (including gastric cancer patients).      Secondary Objectives:      To characterize and confirm the global safety profile of SAR125844 including cumulative     toxicities.      To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects     (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the     relationship of MET gene amplification status with antitumor effects.      To evaluate other pharmacodynamic biomarkers.   "
124417|NCT01657201|"     The purpose of this study is to evaluate the pharmacokinetic properties and safety of     SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).   "
124418|NCT01657188|"     Prospective, follow-up registry of heart failure patients with or without sleep-disordered     breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with     Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac     performance and event-free survival.   "
124419|NCT01657175|"     This study aim to assess quality of life of patients 0-5 years after oesophageal or gastric     cancer surgery and to develop and test an information and support program aiming to enhance     the patients quality of life (QOL) after surgery. The project contains 3 part-studies     focusing on the patients life after surgery.      Data will be collected through focus group interviews and a randomized controlled trial (RCT)     study.   "
124420|NCT01657162|"     The purpose of this study is to provide 24 months of standard of care data on subjects     previously enrolled in study BA058-05-003.   "
124421|NCT01657149|"     To investigate the effects of lymphatic drainage massage performed immediately after total     knee replacement in relation to reduction of limb circumference, pain reduction and     functional improvement.   "
124422|NCT01657136|"     The aim of this study is to prospectively compare the effectiveness and safety of ivabradine     and beta-blockers in the treatment of inappropriate sinus tachycardia.   "
124423|NCT01657123|"     Exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic     nervous system, depending on the type and intensity of the stressor. Physical exercise     represents a stress condition influencing many systems in the body. Given a workload of at     least 70-85% of Vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal     (HPA)-axis. The increased endogenous cortisol secretion results in important metabolic and     cardiovascular effects to maintain cellular and organ homeostasis. Patients with Addison's     disease are not able to meet the increased demand of adrenal steroids in case of physical     exercise, which may result in an impaired exercise capacity and a prolonged post-exercise     recovery. We hypothesize that a hydrocortisone stress dose increases exercise capacity and     improves post-exercise recovery in patients with Addison's disease.   "
124424|NCT01657110|"     Mild to moderate facial acne is an extremely common disease of teenagers and young adults.     This pilot study will investigate whether treatment with a gel containing tea tree oil     reduces numbers of acne lesions and improves acne in twenty otherwise healthy consenting     participants. The hypothesis is that treatment with tea tree oil gel will result in a     significant improvement in acne after 12 weeks of treatment.   "
124425|NCT01657097|"     Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was     performed to gain information on this inflammation, including effect of intranasal     corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.      The study was randomised, placebo-controlled double-blind in patients, monoallergic to     grasspollen, presenting symptoms of rhinitis and asthma during season.      Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of     treatment intranasal allergen challenge was performed. Measurements were performed during the     full study period.      The study was performed out of pollen season.   "
124426|NCT01657084|"     By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced,     without causing hypoxia in the patient.      Based on the scientific literature on the subject, the study hypothesis is that the fall in     body pH will be able to stop and/or prevent epileptic brain activity.   "
124454|NCT01656720|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in     the treatment of faecal incontinence, compared against placebo   "
124428|NCT01657058|"     Soluble, viscous fibre has been established as an effective dietary component for lowering     postprandial glycemia and promoting satiety. The effectiveness of viscous fibre has been     related to its ability to increase the viscosity of the intra-luminal contents of the small     intestine. Hence, the proposed mechanism with which soluble fibre affects the glycemic     response, dependent on the viscosity development in the gut, would require that soluble fibre     be extractable from the food matrix. This, in part, may be dependent on the food matrix that     the soluble fibre is incorporated in. While properties of soluble fibre and their     physiological effects have been studied extensively, limited data exists on the most     effective mode of administration of fibre to optimize benefits. Furthermore, there are no     studies to date that have evaluated how different modes of highly viscous soluble fibre would     affect the subsequent meal. Hence, we propose a research study to determine whether the form     of administration, taking into consideration the carbohydrate availability of a viscous fibre     blend supplement, has a significant impact on postprandial and second meal glycemic response     and subjective satiety in healthy individuals.   "
124429|NCT01657045|"     This study will investigate the safety and efficacy of using JVS-100 to accelerate wound     healing and reduce scar formation in subjects receiving surgical incisions (sternotomies)     during cardiovascular surgery. Twenty-five (25) subjects receiving a median sternotomy of 16     - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be     followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be     enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of     needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be     delivered along the edge of the sternal wound using a needle-free injection device that has     FDA-clearance for subcutaneous injections.   "
124430|NCT01657032|"     Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized,     double blind, placebo-control trial was performed to assess the effectiveness of both LGG and     smectite in management of children with acute gastroenteritis (AGE).   "
124431|NCT01657019|"     To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or     70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults   "
124441|NCT01656889|"     This study is being done to find out if an investigational product called HP802-247 can help     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by     the U.S. Food and Drug Administration (FDA).      This research is being done to compare the efficacy of HP802-247 plus compression therapy     against Vehicle plus compression therapy in achieving complete wound closure over the 12-week     treatment period. Vehicle looks the same as HP802-247 but contains no cells.   "
124442|NCT01656876|"     The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror     therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people     with stroke.   "
124443|NCT01656863|"     The purpose of this study is to determine parental attitudes towards oral rehydration therapy     for children with mild to moderate dehydration.   "
124432|NCT01657006|"     The investigators intend to prospectively enroll consecutive patients, without known ischemic     heart disease, referred by their physician for routine exercise MPI at a tertiary care     center.      Prior to the MPI (nuclear stress test), eligible and consenting patients will undergo a     one-hour period of Holter ECG digital recording. Application of ECG electrodes will be     performed by medical technicians following standard recommendations, utilizing approved     Holter device & stickers. The Holter ECG data will be used for the offline heart rate     variability (HRV) analysis by the HeartTrends device.      Immediately following data acquisition, all patients will undergo an exercise MPI according     to accepted clinical practice guidelines.      Following the MPI, there will be no interference with patient management, which will be     conducted by the patients' treating physicians according to current guidelines, unaware of     HRV results.      Analysis of recorded ECG data for HRV will be performed blinded to the EST and MPI results,     by HeartTrends device.      The results of the HRV tests will not be available to treating physicians and will not be     used to guide patient management. Patients will be followed for 6 months for the occurrence     of coronary interventions and MACE, defined as: death, myocardial infarction, unstable     angina, or any coronary revascularization.   "
124433|NCT01656993|"     Background: Blood clots cause poor outcomes, including death, in babies with heart defects     that require a surgical connection (shunt) to provide blood flow to their lungs. Aspirin     (ASA) blocks the part of the blood that helps clots form (platelets). Aspirin is used in     babies with shunts to prevent blood clots. The dose of aspirin given to babies is based on     adult research. Because babies are different from adults, the investigators do not know if     the dose is enough to block platelets, or if it is too much and may cause bleeding. The     investigators can test the platelets using a blood test called Thromboelastography with     Platelet Mapping (TEG-PM). This test needs a small amount of blood so it can be used in     babies.      Hypothesis and Specific Aims: The investigators suspect the aspirin doses typically given     babies are not enough to block platelets and prevent blood clots in their shunts. The     investigators want to determine the percentage of babies whose platelets are not blocked     enough (< 70% inhibition), by using TEG-PM. The investigators also want to determine how     often bleeding or clots occur in babies receiving aspirin.   "
124434|NCT01656980|"     The purpose of the study is to determine the safety and efficacy of intracranially implanted     Carmustine in the treatment of patients with primary malignant glioma.   "
124435|NCT01656967|"     The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu®     Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of     insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu     Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in     patients undergoing general anesthesia for elective surgery.   "
124436|NCT01656954|"     The purpose of this study is to understand and document measurements in heart stroke volume     (the volume or amount of blood pumped per heart beat) and cardiac output (the volume or     amount of blood pumped by your heart per minute) during a passive leg raise maneuver     (elevation of the legs), and to determine if these measurements can predict changes in the     same as a result of fluid or blood product administration.   "
124437|NCT01656941|"     The purpose of this study is to examine the role of genetic variation in the oxidative stress     response on critical perioperative and short-term outcomes after neonatal heart surgery. The     goals will be to determine 1) if the oxidative stress pathway is an important one for     therapeutic intervention in neonates with severe congenital heart defects and 2) if variants     in the oxidative response pathway can be used to identify patients at increased risk for     adverse outcomes.   "
124438|NCT01656928|"     This study assesses the impact of a nutritional intervention aimed at reducing childhood     overweight in German preschoolers.   "
124439|NCT01656915|"     Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an     inflammatory response and examine differences in the inflammatory response between healthy     and compromised subjects.      The purpose of the current study is to examine the inflammatory response in a younger     population (35-45 yrs old) to see whether in this population also differences in the ex vivo     LPS induced cytokine response exists between healthy and compromised subjects, as is seen in     elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will     be included as subjects with compromised health and compared to healthy lean subjects with     the same age (shifting from healthy towards unhealthy, not diseased).      Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory     cytokine response in a healthy population that is different from a response of the     compromised population. The investigators will include subjects aged 35-45 years that differ     in health characteristics, especially blood HbA1c, fat% and waist circumference.   "
124440|NCT01656902|"     For the cartilage cell product NOVOCART® 3D plus, which is used in the study described here,     the company TETEC AG obtained an expanded production authorization from the medication     monitoring authorities in compliance with Section 13, Para. 1 of the Medicinal Products Act     in 2003. This entitles TETEC AG to produce the pharmaceutical product and already distribute     it. More than 6000 patients were already successfully treated with NOVOCART® 3D in Europe     since 2003. In order to obtain a general market authorization for NOVOCART® 3D plus, this     control group study is conducted, in which the superiority of the safety and effectiveness of     carrier-bound Autologous Chondrocyte Transplantation with NOVOCART® 3D plus compared to the     standard of care microfracture surgery needs to be proven. This study further aims at     developing and validating known and new biologic markers for the quality and clinical     efficacy of the product as requested in the context of identity, purity and potency     characteristics of the medicinal/investigational product.      The patients will receive one of the therapeutic procedures in the study. The treatment     procedure which will be used will be decided by a previously specified random process. This     type of study meets the high quality requirements of the statutorily specified safety and     quality regulations which are also referred to as Good Clinical Practice (GCP). The     probability of the patient being allocated to one of the two treatments is 2:1; that is, an     approx. 67% probability of therapy with NOVOCART® 3D plus and an approx. 33% probability of     therapy with microfracture. Neither the patient, nor the investigator will be able to     influence the treatment assignment.      Patients will be screened for eligibility at the Screening Visit. Each patient will remain in     the study for 36 months post-implant for the effectiveness assessments, and then an     additional two years to complete the planned post-market phase. Each patient will be in the     study for up to five years.      Cells and tissues collected from this study will be used in other in vitro-controlled     experiments aimed at developing and validating known and novel biologic markers to quantify     cell quality in the context of identity, purity and potency. Prognostic values of these     biologic markers will be examined by correlating them with clinical data collected in this     study.   "
124444|NCT01656850|"     The purpose of the study is to examine whether almond consumption for 3 month will help     Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of     cardiovascular disease.   "
124445|NCT01656837|"     Parental substance abuse is a leading determinant of child maltreatment and, consequently, is     often linked with negative clinical outcomes for children, exorbitant financial costs for the     child welfare system, and serious social costs for the investigators nation. Yet, in spite of     the seriousness of child maltreatment in the context of parental substance abuse and that     there are well-established effective treatments for adult substance abuse, substance-abusing     parents in the child welfare system are less likely to be offered services and receive     services. Well-integrated treatments for the dual problem of substance abuse and child     maltreatment are virtually nonexistent in the research literature. This study is a randomized     controlled trial comparing Comprehensive Community Treatment to Multisystemic     Therapy-Building Stronger Families (MST-BSF), an integrated model of two evidence-based     treatments for parental substance abuse and child maltreatment that has shown promise in a     4-year pilot.      Statement of Study Hypothesis:      Compared to Comprehensive Community Treatment, parents receiving MST-BSF will show greater     reductions in parental substance abuse and psychological distress, greater increases in     employment, drug-free activities, social support, and positive parenting, and fewer incidents     of reabuse of a child. Children whose families receive MST-BSF will experience fewer child     out-of-home placements and greater reductions in internalizing symptoms such as anxiety.   "
124446|NCT01656824|"     Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil     reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice     and transform their bone marrow cells into non-Bv8 producing cells. than we will implant     primary human tumor tissue (taken from surgical specimens after informed consent)in those     mice and follow-up on the mice.   "
124447|NCT01656811|"     Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II,     parallel-group study of up to four weeks in duration. The study consisted of a screening     visit followed by a one-week single blind placebo period. At next visit, each subject was     randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180     mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4     times a day for 21 days.   "
124448|NCT01656798|"     The main objective of this study is to estimate the effect of food on sildenafil     pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of     sildenafil citrate.   "
124449|NCT01656785|"     This is an open-label brain PET/CT (positron emission tomography/computed tomography) study     to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of stroke     patients in convalescence. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg     BNOTA-PRGD2) will be intravenously injected into the patients. Visual and semi-quantitative     method will be used to assess the PET/CT images. Changes of 18F-FDG PET/CT, enhanced brain     MRI or CT, and any adverse events will be collected from the patients.   "
124450|NCT01656772|"     This study will evaluate the use of a robotic device that is remotely controlled to maneuver     a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation     procedures.   "
124451|NCT01656759|"     Applying a fibrin spray, after knee device implantation, will help in reducing patient blood     loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased     blood loss there should be a reduced need for blood transfusions.   "
124456|NCT01656694|"     This study will be conducted to assess the survivorship of a particular prosthesis used in     unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed     with isolated medial or lateral compartmental arthritis and have failed conservative     treatment. The patients received a unicompartmental knee replacement using the Sigma® HP     Partial Knee System.   "
124457|NCT01656681|"     The purpose of this 2-stage intervention study is to investigate the effect of a novel     nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and     weight loss maintenance in obese participants.   "
124458|NCT01656668|"     The purpose of this study is to investigate the effect of BC1036 (theobromine) on     cough-related quality of life and cough severity following 2 weeks' treatment.   "
124459|NCT01656655|"     PTSD affects a wide variety of symptoms, some of which have been shown to disrupt family     relationships. This study will examine some of the effects on parenting, from the perspective     of the parent with PTSD.   "
124460|NCT01656642|"     This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of     atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with     vemurafenib or vemurafenib plus cobimetinib in participants with BRAFV600-mutation positive     metastatic melanoma. Enrolled participants may continue treatment until they are no longer     experiencing clinical benefit as assessed by the investigator and in alignment with the     protocol.   "
124468|NCT01656538|"     Researchers doing this study want to evaluate the side effects of Reolysin when given     together with paclitaxel. As these drugs have not been given together before, 6-9 patients     will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.   "
124469|NCT01656525|"     Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and     preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to     moderate AD.   "
124725|NCT01653132|"     This study is being conducted this study to determine whether injections of Xeomin®, a type     of botulinum toxin into the glands that produce saliva (one pair just below and in front of     the ear and the other just under the jaw line) are safe and effective to treat excessive     saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.   "
124461|NCT01656629|"     Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility     fractures are devastating consequences of osteoporosis. The most common treatment approach in     osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid     hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy     with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone     progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called     Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis     medicines may have differing effects on this process. The effects of ALN versus PTH on bone     progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN,     PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be     treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include     bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates     for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual     X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone     progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites,     and 3) increase bone progenitor number in peripheral circulation. Furthermore, the     investigators hypothesize that ALN treatment will have the opposite effect. Understanding the     differences in bone progenitor cell activity and recruitment during osteoporosis therapy will     provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in     osteoporosis treatment.   "
124462|NCT01656616|"     The costs to a rural emergency medical services (EMS) system of a change from a traditional     cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. The     purpose of this study is to use current EMS data to calculate the costs to a rural EMS system     associated with the adoption of a hydroxocobalamin protocol for the treatment of suspected     cyanide exposure.   "
124463|NCT01656603|"     This study will evaluate the safety of infusion of the investigational cord blood units by     carefully documenting all infusion-related problems.   "
124464|NCT01656590|"     The research protocol will be submitted for approval to the institutional review board of     Columbia University Medical Center. An attempt will be made to recruit at least 6 juvenile     patients between the ages of 8 and 17, preferably who are still ambulatory.      Subjects meeting all eligibility criteria will undergo a full history and physical     examination, including details of age of onset of symptoms, distribution and severity of     muscle weakness, muscle function, pulmonary function, and nutritional status. Subjects will     undergo an electrocardiogram (ECG), spirometry, muscule strength evaluation, exercise     capacity, functional muscle tests, laboratory tests, and muscle biopsy. Quality of life will     be assessed via SF 36 questionnaire. Functional ability and level of handicap will be     assessed by Rotterdam handicap scale. Written informed consent will be obtained from all     subjects.      All patients, who will have received enzyme replacement therapy (ERT) for at least 2 years,     will be evaluated prior to institution of high protein nutrition and exercise therapy plus     nocturnal enteral feeding (HPET + NEF)(baseline), then again at 3 months, 6 months and 12     months into treatment. The following parameters will be evaluated-        -  Skeletal Muscle Function        -  Biochemical parameters from collected blood sample Muscle Biopsy will be obtained at          baseline and at 12 months. Biopsy specimens, obtained from thigh muscle at baseline and          a repeat biopsy of the corresponding area of the other leg at 12 months, will be          analyzed as follows:.        -  Histology and electron microscopy        -  Autophagic and lysosomal function evaluation        -  Body composition Body mass index (BMI), body composition, lean body mass, and fat mass          will be measured at each visit by bioelectric impedance analysis using BI-101Q RJL          Systems, software 3.1b   "
124492|NCT01656213|"     TITLE Randomised Control Trial (RCT) for improving functional outcome from stroke in renal     disease patients DESIGN Eandomised Conrol Study AIMS        1. Undertake detailed characterisation of stroke (including recently developed imaging          techniques at Imperial) of stroke in renal disease patients including clinical, imaging          and epidemiological data        2. To Investigate if passive intervention using hand grip device during dialysis sessions          will improve functional outcome from stroke in end stage renal disease patients.      OUTCOME MEASURES        1. Primary outcome:. 3 months change in Upper-Extremity Fugl-Meyer scores.        2. Secondary outcome: 3 months change in NIHS & Bartel scores      POPULATION Ischaemic and haemorrhagic stroke patients with renal disease treated at     Hammersmith's Hospital's renal Unit. .      ELIGIBILITY Data of all patients with renal disease and imaging proven stroke will be     retrospectively analysed. RCT will be conducted on End Stage Renal Disease patients with     acute (<7 days) stroke affecting arm.      DURATION 2 years   "
124465|NCT01656577|"     Background:      - Stress can cause people to give in to temptations to eat less healthily. People who are on     weight loss diets often have problems sticking to their diets when they are stressed. Some     tests have shown that the drug pexacerfont can help reduce stress-related seeking of     high-calorie foods. However, it has not been tested on reducing food craving. Researchers     want to test pexacerfont on people who are on diets to see if it can reduce stress-related     food cravings.      Objectives:      - To see if pexacerfont can help reduce stress-induced food cravings.      Eligibility:      - Individuals between 21 and 65 years of age who are on a diet to control their weight.      Design:        -  Participants will be screened with a physical exam and medical history. This study          requires seven visits over about 35 days.        -  Participants will take either pexacerfont or placebo pills during the study. They will          have three pills every morning. They will record video of themselves taking the pills          every day.        -  Every evening, participants will fill out a questionnaire. It will ask questions about          feelings and behaviors related to eating and food craving.        -  Participants will have regular study visits while taking the pills. The visits will          involve questions about stressful situations and food cravings. One visit will involve a          mildly stressful math test, followed by tasting of different foods. This test will look          at whether pexacerfont can affect food preferences. Participants will provide blood and          saliva samples as directed at these study visits.        -  Participants will have follow-up phone calls 1, 3, and 6 months after the end of the          study.   "
124466|NCT01656564|"     Background:      - Long-term survival with the human immunodeficiency virus (HIV) is not well understood.     Adults who were infected with HIV as children have lived with the virus for many years.     However, the effect of HIV on this group of people has not been studied in depth. Researchers     are interested in studying how HIV infection and the medicines used to treat it affect people     who were infected early in life. They want to find out if there are any problems with how     HIV-infected children grow and develop as adults, especially if they have developed heart     problems. As part of this study, people with HIV will be compared with healthy volunteers.      Objectives:      - To study the effect of HIV infection and treatment on people who acquired HIV infection in     early life.      Eligibility:        -  Individuals at least 18 years of age who were infected with HIV before age 10.        -  Healthy volunteers at least 18 years of age who have no history of heart disease.      Design:        -  Participants will be screened with a physical exam and medical history. They will have          regular study visits about once a year for up to 10 years to collect health information.        -  Blood and urine samples will be collected to look at kidney and liver function.        -  X-ray scans will be used to look at bone density and the amount of fat and muscle in the          body.        -  Heart function tests and imaging studies, including ultrasound and echocardiograms, will          be used to look more closely at the heart.        -  Treatment will not be provided as part of this study.   "
124467|NCT01656551|"     The purposes of this study are to test whether the addition of cisplatin to single agent     chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with     non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs     survival as compared to gemcitabine in elderly patients with non squamous NSCLC.   "
124470|NCT01656512|"     Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for     one fourth of all childhood cancers & 74 % of childhood leukemia. Based upon drug registry     data, children prescribed more than three courses of systemic glucocorticoids yearly faced a     20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids     were discontinued, and fracture rates returned to expected for age by 1 year after treatment     (Journal Of Clinical Endocrinology & Metabolism 2009). The investigators will study the role     of bisphosphonates in the prevention of secondary osteoporosis in children & adolescents     treated for ALL in the Children's Cancer Hospital -Egypt.   "
124471|NCT01656499|"     The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism     and gut health   "
124472|NCT01656486|"     Patients that have undergone pre-operative radiation for pancreatic carcinoma, that upon     pathologic examination of the normal portion of the pancreatic gland that was in the     radiation field showed acute and chronic changes in the pancreatic cells. The hypothesis for     utilizing stereotactic radiation on pancreatic fistulae is that the treatment will decrease     pancreatic secretions, thus decreasing autodigestion.   "
124473|NCT01656473|"     The purpose of this study is to evaluate the preliminary effectiveness and feasibility of an     integrated treatment approach for youth with concurrent disorders. The combined intervention     will include individual sessions of Motivational Interviewing, followed by inclusion in a     Dialectical Behaviour Therapy skills-based group.      The following main hypotheses will be examined:        1. Youth with CD who receive an MI intervention will show increased motivation and          readiness to change from pre to post MI intervention.        2. Youth with CD who participate in a DBT intervention (orientation session followed by          12-week DBT skills training group)will show reductions in substance use and improvements          in mental health, coping and affect regulation between pre to post treatment. The          investigators expect that these treatment gains will be maintained at three-month          follow-up.   "
124474|NCT01656460|"     The purpose of this study is to evaluate the efficacy and toxicity stereotactic body     radiation (SBRT) as consolidation following standard chemoradiation for patients with stage     III non-small cell lung cancer.   "
124475|NCT01656447|"     The overall objective of the Scleroderma Registry is to support and promote the basic science     and clinical research of this complex rheumatic disease at the Hospital for Special Surgery     (HSS). The registry facilitates our understanding of the clinical features, pathobiology,     genetics of Scleroderma. This will ultimately lead to a potential treatment for this     currently untreatable condition.   "
124476|NCT01656434|"     The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate +     17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active     American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were     assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol     (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.      Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of     Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio     was adapted accordingly for participants randomized after the sample size increase.   "
124477|NCT01656421|"     Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of     cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular     disease is a major cause of death in such patients and it may be related to excess stiffening     of the walls of major arteries, such as the aorta, and it has been suggested to represent     premature aging. However, there is little known of the development of these problems, which     were previously considered to be due to smoking and which is now known not to be the only     factor. The investigators will study a large group of patients with mild to very severe     airflow obstruction based on the NICE 2010 classification of severity and a matched     comparator group free of COPD. This study involves three assessments of the development of     the complications of COPD over a five year period. The key measure will be the rate of change     in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in     wall stiffness will be related to the severity of lung disease; other known cardiovascular     risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular     events including heart attacks and death; and to the presence of other complications, such as     osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the     context of changes in bodywide inflammation and metabolic function and the changes in the     rate of ageing. This increased knowledge of interacting factors in the complications of COPD     is likely to lead to studies of treatments to avoid their development.   "
124478|NCT01656408|"     This randomized, double-blind, placebo-controlled, multiple-rising-dose study will evaluate     the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8150 in healthy young     men, in male participants with mild to moderate hypertension, in elderly male and female     participants with mild to moderate hypertension, and in male and female participants with     resistant hypertension. A primary study hypothesis is that there is at least one dose that     does not increase heart rate (HR) to a clinically meaningful extent in male participants with     mild to moderate hypertension and in elderly participants with mild to moderate hypertension     on either Day 1 or the last Day of multiple dosing (Daylast), as measured by Time-weighted     Average Across 24 hours (TWA0-24hrs). The hypothesis is met if mean increase (MK-8150 -     placebo) in TWA0-24hrs HR in the identified groups is ≤15 beats per minute on Day 1 and     Daylast.   "
124479|NCT01656395|"     The purpose of this adaptive-design study is to evaluate the dose-related effectiveness and     safety of MK-1029, alone or in combination with montelukast, compared to placebo and to     montelukast alone, in the treatment of persistent asthma in adults.   "
124480|NCT01656382|"     The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7     days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of     patients with disseminated cryptococcosis and HIV.   "
124481|NCT01656369|"     The aim of the study is to compare Delorme operation alone or with post anal repair and     levatorplasty for treating complete rectal prolapse.consecutive patients who were treated for     complete rectal prolapse at the Colorectal Surgery Unit were eligible for the study.The     patients were randomized into two groups: Group I: consisted of patients were subjected to     delorme operation only. Group II: consisted of patients were subjected to delorme operation     with post anal repair and levatorplasty.   "
124483|NCT01656343|"     -  To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD)          in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept          at the time of transplantation        -  To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone          transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the          time of transplantation        -  To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant          recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone          transplant recipients treated with CNI-based regimens at the time of transplantation   "
124484|NCT01656330|"     The purpose of this study is to assess the use of 2 different Prothrombin Complex     Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of     rivaroxaban in healthy adult volunteers.   "
124485|NCT01656317|"     The study's main objective will be to assess which effect early initiated rehabilitation has     on the frequency of complications and the level of physical and cognitive functioning after     aneurysmal subarachnoid hemorrhage (SAH).      To this end the following aspects will be investigated:      The frequency of complications (with special emphasis on pulmonary     complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains     and lines)        -  Length of stay in hospitals and socio-economic impact        -  Physical and cognitive function in the early and chronic phase after SAH        -  Health-related quality of life and participation in society in the chronic phase   "
124486|NCT01656304|"     This pilot phase II trial studies how well giving bevacizumab works in treating patients with     relapsed prostate cancer that did not respond to hormone therapy. Monoclonal antibodies, such     as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor     cells to grow and spread. Others find tumor cells and help kill them or tumor-killing     substances to them. Bevacizumab may also stop the growth of prostate cancer by blocking blood     flow to the tumor   "
124487|NCT01656278|"     The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided     treatment strategy based on a predefined treatment algorithm can prevent progression of     erosive joint damage, increase remission rate and improve functional level in the short and     long term in patients with rheumatoid arthritis (RA).   "
124488|NCT01656265|"     The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in     hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the     recommended dose of ARQ 197 in advanced HCC patients.   "
124489|NCT01656252|"     Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag     while undergoing consolidation chemotherapy with high-dose cytarabine. Eltrombopag may help     increase the number of platelets during chemotherapy and may help prevent the risk of     bleeding.      Phase I will study the side effects, best dose and platelet effects of eltrombopag when given     with consolidation chemotherapy. After the maximum safe and tolerated dose and schedule is     found in Phase I, the study will proceed to Phase II. Phase II will confirm the dose and     schedule of eltrombopag identified in Phase I that can increase platelet counts in patients     receiving consolidation therapy.   "
124493|NCT01656200|"     Japanese encephalitis (JE) live attenuated vaccine SA14-14-2 has been in use for more more     than 20 years in Asia. JE vaccine SA14-14-2 is licensed in India and has been widely used     since 2006. JE vaccines give protection by generating a neutralizing antibody response, but     both naturally exposed persons and patients with JE also have T cell responses. Whether JE     vaccine SA14-14-2 elicits T cell responses is unknown. This study tests the hypothesis that T     cell responses are generated in response to JE SA14-14-2 vaccination. The aim of this study     is to characterize T cell responses to JE vaccine SA14-14-2 in healthy people, and to     investigate differences in T cell responses between natural exposure, vaccination and     disease.   "
124495|NCT01656174|"     The objective of this study is to test individual donor samples (IDSs) with the     investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue     Assay in the clinical setting.   "
124496|NCT01656161|"     The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg     6-month formulation administered by the subcutaneous (under the skin) route in:        -  achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days          after investigational medicinal product (IMP) injection], and        -  in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month          12 (Day 337) in participants with advanced prostate cancer.   "
124726|NCT01653119|"     The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin     on recurrent events in patients with established DM who is admitted for an ACS.   "
124497|NCT01656148|"     Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two     pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking     speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk     Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not     been investigated in patients responding to the drug measured by the abovementioned test.      The question is if this will be the case and also if another walking test, termed the Six     Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.      Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not     less sensitive to the effect of Fampridine-SR than T25FW.   "
124498|NCT01656135|"     To investigate the progression of the immunological response in living-donor kidney     transplant recipients treated with a standard immunosuppressive regimen. Clinical,     immunological, and health-economic data collected during this Reference Group Trial will be     used to corroborate historical renal transplantation statistics and generate reference ranges     for future clinical studies that will test immunoregulatory cell therapy as an adjunct     immunosuppressive treatment in renal transplantation.   "
124499|NCT01656122|"     The purpose of this study is to assess the pharmacokinetic parameters for ABC and 3TC in     HIV-infected children younger than 18 years old with body weight ≥ 14 kgs.   "
124500|NCT01656109|"     There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in     HIV-infected Asian children. Therefore, the investigators aim to evaluate the     pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.   "
124501|NCT01656096|"     The purpose of this study is to examine the benefit of renal sympathetic denervation in     patients with mild refractory hypertension   "
124502|NCT01656083|"     Research indicated that the relapse rate of smokers who attempted to give up smoking without     drug and other assistance is up to 90-95% while the successful cessation rate may be improved     a lot with assistance to quit smoking. There are two kinds of measures to help smokers quit     smoking: one is psychological and behavioral intervention, including the advice to quit     smoking provided by doctors during daily health service and smoking cessation hotline;     another is provision of drug therapy. 2008 smoking cessation Guidance plays emphasis on the     effectiveness of smoking cessation of Varenicline and also on role of doctor's behavioral     intervention in smoking cessation as Class A of evidence-based rating; among which, doctor's     consultation (three minutes) at minimum intensity is effective; high-intensity consultation     (more than ten minutes) is more effective than that of low-intensity consultation; and return     visit for more than four times will distinctively improve the smoking abstinence rate. It is     unrealistic to apply high-intensity and high-frequency smoking cessation intervention on all     smokers due to the busy clinical work of domestic doctors. Systematic and standardized short     message intervention system may be helpful to improve abstinence rate. Meanwhile, it can     reduce human labor and physical resources, and improve the frequency of follow-up visit to     smokers. It is observed during the process of offering smoking cessation services to smokers     that, it would be one of the very effective measures to provide timely and useful information     to smokers at several critical phases of smoking cessation course (such as three weeks before     smoking cessation, prevention of relapse, etc.). Doctors, however, are usually passive during     this period and unable to provide assistance to smokers with initiative. As people are more     and more aware of the harmfulness of smoking and more and more smokers are increasingly     willing to give up smoking, it is necessary to create an instant active information     distribution system, which provides immediate active smoking cessation short message support     through universally used mobile phone short message service to achieve the purpose of helping     them quit smoking.   "
124503|NCT01656070|"     Along with its effects on bone metabolism, vitamin D is an important modulator of the immune     system. Experimental studies have shown that the active metabolite of vitamin D [1,25(OH)2D]     is able to skew the T cell compartment into a more anti-inflammatory state, with inhibition     of Th1 and Th17 cells and promotion of Th2 and T regulatory subsets.      In the context of HIV infection, in which Th1 subpopulations are devoted to inhibit viral     replication, any alteration of the Th1/Th2 balance would be of concern.      The aim of this Randomized Controlled Trial is to test wether oral supplementation with     cholecalciferol could be able: 1) to improve vitamin D status and, 2) to play an     immunomodulatory role, in vertically HIV-infected children and young adults with     hypovitaminosis D.   "
124504|NCT01656057|"     The last couple of years it has been shown that bile acids not only acts as simple     emulsifiers of fat, but constitutes a complex metabolic integrator which not only have an     influence on fat digestion and lipid metabolism, but also modulates the energy expenditure in     (brown) adipose tissue and muscle tissue. This action is due to stimulation of the receptor     TGR5 by bile acids. Recently scientists have discovered that this receptor in rodents is also     expressed on the surface of intestinal L-cells (which normally secrets Glucagon-Like     Peptide-1 (GLP-1) in response to nutrient stimulation). The stimulation of this receptor has     shown a GLP-1 secretion from the intestinal cells which is interesting since GLP-1 has a     central role in maintaining normal glucose tolerance and thus blood sugar. Given the above,     bile acids has an important impact on intestinal GLP-1 secretion. Whether these scientific     findings can be proven in human beings is uncertain.      The primary hypothesis is that stimulating gall bladder emptying via Cholecystokinin (CCK) in     healthy subjects will result in a significant GLP-1 response. We also hypothesize that adding     orally Metformin or a sequestrant (a bile acid binder) will further enhance this GLP-1     response.   "
124520|NCT01655849|"     This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for     safety and efficacy for a period of 6 weeks.   "
124505|NCT01656044|"     The purpose of this research study is to evaluate if a negative-pressure dressing placed over     a surgical incision can reduce the risk of developing a surgical site infection compared to a     commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing     will be compared to a standard post-surgical sterile gauze dressing. In this study patients     will either receive a negative-pressure dressing or a standard sterile gauze dressing   "
124506|NCT01656031|"     RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different     ways to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.      PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to     see how well they work in treating patients with refractory or relapsed acute myeloid     leukemia or acute lymphoblastic leukemia.   "
124507|NCT01656018|"     The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what     the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics     (what the medication does to the body) of TMC278 long acting (slowly effective after initial     dosage and maintaining its effects over a long period of time) when administered as an     intramuscular (ie, in to the muscle) injection in adult participants who are seronegative for     human immunodeficiency virus type 1 (HIV-1).   "
124764|NCT01652612|"     Hypoxia frequently develops during one lung ventilation in the supine position.The objective     of this article is to study the impact of preemptive alveolar recruitment and subsequent     positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung     ventilation in the supine position in patients undergoing thoracic surgery .   "
124508|NCT01656005|"     Beta blockers are a type of medication mainly used for heart disease. They are commonly used     to treat 'angina' and to prevent heart attacks. Patients with COPD are more likely to suffer     from heart disease and so already benefit from this treatment for this reason. In addition to     this, new research suggests that there may be further benefit of using beta blockers for     COPD, even without also having heart disease.      The reason why beta blockers are not widely used in COPD at present is because of their     potential to make symptoms of COPD worse by causing the airways to narrow. Beta blockers are     the opposite type of medication to 'beta-agonists' such as salbutamol which you may be taking     for symptoms of breathlessness or wheezing. Nevertheless beta blockers are still used in COPD     where the benefits (for example heart disease) outweigh any risks.      Current COPD treatment includes inhaled steroids and long acting beta agonists, often given     in a combination inhaler (e.g. Seretide or Symbicort) to treat both airway inflammation and     airway narrowing, leading to improvement in symptoms. Another drug commonly used is     Tiotropium (Spiriva) which is another type of long acting inhaler medication to help with     widening the airways.      In this study, we wish to find out if two different types of beta blocker cause different     effects on the airways in COPD patients. One type of beta blocker is more 'selective' in     acting mainly on the heart, with the other type having more general or 'non-selective'     effects on both the heart and lungs. By doing this we will also be able to look at how the     beta blockers work alongside the 'usual' inhaler treatment described above.   "
124509|NCT01655992|"     Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.   "
124510|NCT01655979|"     The human being has shown that he can live and work in the space environment, but due to the     lack of essential mechanical load on muscle and bone, the fluid-shift as well as alterations     in the acid-base balance (mainly on account of nutritional factors), the exposure to     microgravity results in a gradual degradation of muscle, bone and cartilage, deconditioning     of the cardiovascular system and metabolic changes. Countermeasures to prevent all the     deconditioning of the physiological systems are not yet fully effective and require further     investigation.      A commonly utilized model of simulating the physiological effects of microgravity on the     human organism on ground is the 6° head-down-tilt bed rest. In the present study the model     has been used to study potential countermeasures to spaceflight-associated deconditioning.      One of the most constrictive changes appearing during space flight as well as during bed     rest, are disuse-induced muscle losses. These are associated with a decrease in muscle     protein synthesis, rather then an increase in muscle protein breakdown. Besides an effective     training countermeasure, nutritional countermeasures gain respect in this context:     supplementing conventional diets with whey protein or essential amino acids has been shown to     increase muscle protein synthesis. Due to these anabolic properties whey protein seems     promising to counteract disuse-induced muscle wasting.      Drawbacks of a high protein intake are calciuric effects, ascribed to the proton-release when     metabolizing sulfur-containing amino acids. The so called 'low grade metabolic acidosis' has     also shown to activate osteoclastic bone resorption and muscle protein degradation.     Therefore, to maximize the anabolic potential of a whey protein supplementation, the     acidogenic properties need to be compensated. As previous works suggest, a shift of acid base     balance into the acid direction and the resulting changes in bone and protein turnover may be     hindered by supplementing alkaline mineral salts.      In this regard, a mid-term bed rest study was performed in order to investigate the effect of     a combined whey protein (0.6 g/kg body weight/day) and potassium bicarbonate (90 mmol/day)     supplementation as a potential countermeasure to multiple physiological and metabolic     alterations on the human body resulting from real and simulated microgravity.   "
124511|NCT01655966|"     Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4.     Conventional standard of care treatment has modest response with only 50% sustained virologic     response. Recent reports have suggested an augmented response with the addition of vitamin D.     This is a prospective randomized trial to assess the effectiveness of adding vitamin D to     standard of care for chronic hepatitis C genotype 4.   "
124512|NCT01655953|"     The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride,     salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced     physiological systems. Due to increased urinary calcium excretion and bone resorption a high     NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline diet     is known to have a beneficial influence on bone metabolism. Therefore the investigators     hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.      8 healthy male volunteers took part in a stationary study carried out in the metabolic ward     of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days.     Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days     of stationary recovery. During the intervention period the volunteers diet was NaCl-rich (7.7     mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium bicarbonate     (KHCO3) in a randomized cross-over design. The other campaign served as control.      Bone metabolism was studied by bone formation markers in the fasting morning blood and     24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in     the fasted and the postprandial state as well as urinary markers. Protein turnover was     studied with stable isotopes. Further physiological systems like energy metabolism and the     cardiovascular system are also under investigation.   "
124513|NCT01655940|"     In this prospective study to try to standardize the care for patients, the investigators are     planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy     in determining the cerebral oxygen saturation as determined by jugular bulb oxygen     saturation. Also, the investigators will compare these devices in terms of their response to     changes in hemodynamics that occur during cardiac surgery.   "
124514|NCT01655927|"     The purpose of this study is to determine whether Tranexamic Acid is effective or not in the     reduction of intraoperative bleeding loss in brain tumors resections.   "
124523|NCT01655810|"     African-Americans have higher rates of cardiovascular disease morbidity and mortality, as     well as vitamin D deficiency. Multiple observational studies have demonstrated an increased     risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation     between cardiovascular disease and vitamin D levels; however, there is a lack of     interventional trials exploring this connection. The objective of this proposal is to address     the hypothesis that treatment of vitamin D deficiency in African Americans with type 2     diabetes will improve subclinical markers of cardiovascular disease.   "
124524|NCT01655797|"     The aim of this study was to investigate the clinical effectiveness of protocol-driven     cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel     (primary care nurses and social workers) in general medical practice with unselected     patients, in line with a stepped care approach. The study design was a randomised controlled     parallel group design, with allocation to CBT and waiting list control group (WL). Following     an active treatment-control period, the control group were re-assigned to CBT. The study     hypothesis was that the CBT group would experience less symptoms of insomnia after treatment     compared with the WL group. Primary outcome measure was a brief self-report screening form,     Insomnia severity index.   "
124515|NCT01655914|"     This study compare the pharmacokinetic (PK) profile of sublingual CRLS035 (two doses) to I.V     flumazenil administration.      Selection of study drug dosage: CRLS035 - sublingual Flumazenil will be administrated at a     final dosage of 1.1 mg per 100 µl and 2.2 mg (200 µl) in a sublingual spray administration.      Currently, Flumazenil is given as an IV drug with a repetitive administration of doses of 0.2     mg up to 3 mg per hour. As the bioavailability of Flumazenil is expected to be lower than the     IV administration, 1.1 mg and 2.2 mg will be tested in sublingual delivery. The suggested     doses in this study are very safe according to the following data: first, sublingual and     buccal administration of Flumazenil have been detailed previously with similar and higher     doses with no side effects, secondly, IV dose may reach 3 mg and thirdly, oral administration     has been reported as up to 600 mg/dose.      The purpose of this study is to determine the single dose PK profile of SL CRLS035. This     study is designed to collect short-term safety data and to monitor the PK profile of CRLS035.      Primary Objective The primary objective is to determine the single dose safety and PK profile     of SL CRLS035 using the marketed IV flumazenil formulation as the comparator.      Secondary Objectives The secondary objectives are to (1) characterize the concentration time     course of two dose levels of SL CRLS035 to support dose selection for Phase 2 and 3 studies     and to evaluate the safety and tolerability of flumazenil formulations; (2)To evaluate the     effect of high fat diet and water consumption on the PK profile.   "
124516|NCT01655901|"     STATEMENT OF THE PROBLEM: Video games have enormous mass appeal, are omnipresent in the daily     schedule of most children and youth and have been linked to the obesity epidemic. The     investigators research group recently reported that sedentary video game playing increases     food intake in adolescents. Interestingly, the overconsumption of food associated with seated     video game play was observed without increased sensations of hunger and appetite, as     previously observed with television viewing. Active video games offer an appealing     opportunity for increasing energy expenditure and promoting healthy body weight among     children and youth who might otherwise be spending time in sedentary screen-based activities.     However, significant increases in energy expenditure as a result of active video game play     might be of little importance to energy balance if one compensates by increasing energy     intake and/or decreasing physical activity. Studies to date have failed to measure energy     intake so it is currently unknown the effects of active video games on daily energy balance.      OBJECTIVE: The main aim of this study is to examine the acute effects of playing active video     games on energy intake and expenditure.      HYPOTHESIS: The investigators hypothesize that the increase in energy expenditure promoted by     active video games will be offset by compensatory adjustments in food intake and spontaneous     physical activity subsequent to the intervention.      RESEARCH PLAN: With the use of a randomized crossover design, 30 normal-weight and 30 obese     adolescents between 13 and 17 years of age will complete three 1-hour experimental     conditions, namely (1) resting in a sitting position (control condition), (2) playing Xbox     360 (sedentary video game condition) and (3) playing Kinect (active video game condition),     followed by an ad libitum lunch. The primary outcomes will be acute (24-h) and short-term     (3-day) energy intake and expenditure. Food intake will be measured using an ad libitum test     meal immediately following the intervention, a food menu for the remainder of the day and a     dietary record for the subsequent 3-day period. Energy expenditure will be measured using     indirect calorimetry during the intervention and an Actical accelerometer for the subsequent     3-day period. Secondary outcomes will include appetite sensations (visual analogue scales),     stress markers (heart rate variability, blood pressure, and mental workload), and levels of     appetite-related hormones and substrates (glucose, insulin, cortisol, leptin, and ghrelin).      RELEVANCE: The present study is innovative and likely to result in a number of new and     important findings that can inform future recommendations. If the investigators confirm our     hypothesis, the clinical implication will be to rethink the strategy of promoting active     video games as an intervention tool for the prevention of overweight and obesity in youth.   "
124517|NCT01655888|"     RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of     tremelimumab in malignant mesothelioma (MM) patients.      PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive     schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive     investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until     confirmed disease progression.   "
124518|NCT01655875|"     This study is for patients 2-21 years old who have acute leukemia that has not responded well     to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study of     AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard     pre-transplant conditioning regimen (total body irradiation, etoposide and cyclophosphamide).     The conditioning regimen is the treatment that is given just before the transplant. This     treatment kills leukemia cells as well as healthy bone marrow and immune cells. Researchers     want to learn more about how AMD3100 affects acute leukemia cells. Blood and bone marrow     samples from study participants will be collected to find out if AMD3100 is making patients'     cells more sensitive to the conditioning regimen and to find out how it does this.      The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that     three doses do not significantly increase the side effects of transplant conditioning, the     investigators will give a second group of six patients five daily doses.   "
124519|NCT01655862|"     This is an observational study to assess health-related quality of life in patients with     cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.   "
124521|NCT01655836|"     The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes     called internal radiation therapy. High dose rate brachytherapy is a procedure that involves     temporarily placing radioactive material inside the patient's body for about 10-20 minutes.     Then, the remainder of the radiation treatment will be given over a 3 week period using     stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves     the delivery of very high individual doses of radiation to tumors with high precision. This     allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose     of this study is to determine the safety of brachytherapy when combined with hypofractionated     SBRT.   "
124522|NCT01655823|"     Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of     many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin,     bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in     greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing     is often either decreased or discontinued potentially affecting tumor responsiveness,     prognosis, and survival.      There is an unmet medical need for treatment of cancer patients with chemotherapy induced     neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of     multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic     pain caused by chemotherapy.   "
124765|NCT01652599|"     The purpose of this study is to determine the response rate and response duration with the     combination of eltrombopag and high-dose dexamethasone   "
138751|NCT01468584|"     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and     Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous     treatment.   "
124525|NCT01655784|"     This trial is being conducted in order to compare angiographic outcomes in patients receiving     0.014-0.0155 platinum framing and filling coils (larger diameter coils) versus those treated     solely with coils less than 0.014 (with a standard diameter).      Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients     receiving 0.014-0.0155 platinum coils during embolization compared to those receiving     smaller-diameter coils.   "
124526|NCT01655771|"     The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated     by the body and to evaluate whether it is safe and well tolerated.   "
124527|NCT01655758|"     This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of     drugs acting either on aqueous humor production (inflow drugs) or on aqueous humor outflow     (outflow drugs) in human eyes affected by ocular hypertension and virgin to treatment. The     enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and     n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured. It is hypothesised that     outflow drugs may offer a better and more stable control of IOP through the 24 hours.   "
124528|NCT01655745|"     This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma     of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This     pilot study is designed to provide preliminary information on the accuracy of [18F]     Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of     muscle-invasive bladder cancer.   "
124529|NCT01655732|"     S. mutans counts have been found to be high in women with high level of untreated caries. In     Pakistan 95% of all carious lesions are untreated that is an alarming situation. A majority     of mother's have high level of caries and pose an increase risk of vertically transmitting it     to their children. Therefore, the aim of this study is to determine the effect of A Traumatic     Restorative Treatment(ART) in reducing S. mutans count in pregnant women and indirectly     reduce the vertical transmission of S. mutans to their children so that ART as a preventive     program may be provided and promoted in periurban areas where there is a lack of     accessibility to oral health care.   "
124530|NCT01655719|"     Through this trial the investigators hope to learn if a drug, Actos (pioglitazone), is useful     in treating a certain kind of metastatic thyroid cancer. Actos is approved by the FDA to     treat diabetes. It has not been approved by the FDA to treat cancer, so its use in this study     is considered experimental.   "
124531|NCT01655706|"     This study is a pilot to assess feasibility of the protocol in patients and controls across     six participating sites. The goal is to identify biological markers (biomarkers)that can be     measured at baseline or early in treatment to predict treatment outcome in individual     patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using     interview and self-report measures), molecular (from blood samples) and neurobiological     (using neuroimaging and EEG).   "
124532|NCT01655693|"     The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is     effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC)     after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and     with good liver functions are eligible. Only those who can not benefit from treatment for     which efficacy is demonstrated are eligible.      These patients are usually proposed either best standard of care (BSC) or participation to     clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or     DT at 30 mg/m2 or the BSC.   "
124533|NCT01655680|"     This is a safety and efficacy study evaluating a experimental treatment for cognitive     deficits in adults with schizophrenia.   "
124534|NCT01655667|"     To characterise and understand the current UK COPD population including demographics, active     comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis   "
124545|NCT01655524|"     The investigators developed a modified regadenoson nuclear stress test of the heart that     incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The     modified (ASSUAGE) protocol has been associated with fewer side effects and was better     tolerated by patients.      This study will investigate whether the modified regadenoson stress protocol (ASSUAGE)     produces blood flow pattern to the heart similar to that of a standard regadenoson stress     protocol. In proven to be the case, the ASSUAGE protocol has the potential to be used on a     wide scale instead of the current standard protocol.   "
124546|NCT01655511|"     This study in healthy male and female volunteers will investigate the safety and tolerability     of three increasing oral doses of tafamidis   "
124535|NCT01655654|"     The primary purpose of this study is to identify the percentage of health care workers     working in an acute care hospital who have high blood pressure, to determine the awareness of     their blood pressure status, and to see how well it is managed. Study participants will come     from the following three distinctly different types of departments: telemetry (clinical),     non-telemetry (clinical), and non-direct patient care staff. All study participants are     offered educational information surrounding high blood pressure and review the recommendation     for their primary care engagement. Study participants with high blood pressure will be asked     to continue in the study for up to 6 months. It is intended that each study participant who     continues will take their blood pressure three times a day and record the results in a study     provided diary. Each study participant should also make some of the suggested changes that     promote a healthier lifestyle including exercising, improving their diet, and seeing their     primary care provider. It is the thought that these changes will reduce the study     participant's blood pressure. The secondary purpose is to determine the effect shift work has     on these hospital employees and the potential positive effects of the three interventions.   "
124536|NCT01655641|"     Primary objective of the study is to compare requirement of blood transfusion and mortality     in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it.      Secondary objective is to; assess the re-bleeding events; need for surgical intervention;     length of stay in Intensive care unit in between the two groups.   "
124537|NCT01655628|"     Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in Southern China     and South Asia. After radiotherapy, some patients with nasopharyngeal carcinoma still had     distant metastasis. In recent years, some chemotherapeutic agents, such as gemcitabine,     cisplatin, were used to treat patients with advanced nasopharyngeal carcinoma, including     those with local recurrence and distant metastases, with a certain short-term effect.     However, chemotherapy alone is still not ideal for effectively improving the prognosis of     patients with advanced nasopharyngeal carcinoma. Therefore, it is necessary to develop     more-effective adjuvant therapies.      CIK cells (cytokine induced killer cells, CIK) are a population of heterogeneous cells     generated by the in vitro amplification of mononuclear cells in peripheral blood. The cells     are co-induced with multiple cytokines; the lymphocytes with co-expression of CD3+CD56+ have     the strongest anti-tumor effect. Because of their non-MHC restricted tumor killing activity,     CIK cells have a powerful anti-tumor effect both in vitro and in vivo, which spans a broad     anti-tumor spectrum.      In this study, the patients with post-radiotherapy distant metastasis of NPC will be treated     with autologous CIK cells in combination with Gemcitabine plus Cisplatin regimen     chemotherapy(GC). The purpose of this study is to observe and evaluate the toxic side effects     and the short- and long-term efficacy of CIK used in combination with GC chemotherapy to     treat NPC in patients with distant metastasis after radiotherapy. Patients and Methods: 40     patients with distant metastasis after radiotherapy will accept 4 cycles chemotherapy of     Gemcitabine plus cisplatin regimen and then are randomized divided into 2 groups. The 20     patients in GC+CIK group will be treated with maintaining therapy of adoptive autologous CIK     cell transfusion sequentially; the other 20 patients will be followed-up only without CIK     cells treatment. The safety of chemotherapy and CIK cells transfusion and the tumor     regression status will be observed. The early response and long-term efficacy of two groups     patients who accept GC chemotherapy or GC +CIK bio-therapy will be investigated.   "
124538|NCT01655615|"     The Preventure Program is the first and only school-based alcohol and drug prevention program     that has been shown to prevent onset and growth in alcohol and substance misuse in British     and Canadian youth. Unlike universal programs that tend to promote generic coping skills and     balance normative attitudes around substance use, this selected personality-targeted approach     is based on a psychosocial model and validated by Dr Patricia Conrod and targets four     personality-specific motivational pathways to substance misuse: Hopelessness, Anxiety     Sensitivity, Impulsivity and Sensation Seeking, each associated with different motives for     substance use, drug use profiles and patterns of non-addictive psychopathology.      As a primary goal of the Coventure project, the investigators propose a long-term trial of     this intervention strategy to examine how this evidence-based intervention can reduce onset     of substance use disorders in young people and related secondary mental health, academic and     cognitive outcomes.      As a secondary goal, the investigators propose to use sensitive neuropsychological measures     to examine how this evidence-based intervention can positively impact on cognitive     development over the course of adolescence, to tease apart some of the mechanisms involved in     the causal pathway from early onset substance use to poor cognitive development and long-term     addiction outcomes.   "
124539|NCT01655602|"     This study aim to compare cosmetic results between 3 trichophytic closure techniques for     donor site (the trimming of upper, lower and both edge of linear incision) in hair     transplantation.   "
124540|NCT01655589|"     The main purpose of this study is to investigate the association between VEGF gene     polymorphism and the response to intravitreal drugs in neovascular age-related macular     degeneration. This is a retrospective review of patients treated between 2008 and 2012 at the     Institute of Vision, in Belo Horizonte, Brazil.   "
124541|NCT01655576|"     The purpose of this study is to determine if placental drainage shortens third period of     labor and reduces postpartum blood lost.   "
124542|NCT01655563|"     Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid     organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus     through genetics will help in early attainment and maintenance of the correct dosage level in     the early post-transplant period. This pilot dose-finding trial will help to determine a     dosing strategy guided by genotypes and age for solid organ transplant recipients that will     be further validated through a multi-centre trial as an immediate next step. The study     hypothesizes that dosage levels determined through age and genotype will be attained faster     and more accurately than the standard dosing procedures in the 14-days after the transplant.     Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster     recovery (tested through the kidneys' ability to clear creatine from the blood) and result in     lower frequencies of adverse effects and rejection of the transplant.   "
124543|NCT01655550|"     The investigators seek to demonstrate the non-superiority of oral contrast versus no oral     contrast in intravenously enhanced CT in the outpatient setting. The investigators want to     decrease preparation time for the patient and decrease delay in obtaining the study which     will ultimately lead to faster results and an increased level of patient convenience.      The investigators hypothesis: Oral contrast does not significantly affect the diagnostic     confidence of interpreting radiologists in intravenously enhanced abdominal CT scans.   "
124544|NCT01655537|"     Fibromyalgia is a common rheumatologic disorder. Many patients complain of cognitive     dysfunction as part of their symptoms.      The investigators aim to assess this cognitive dysfunction through extensive neuro-cognitive     testing.   "
124547|NCT01655498|"     The objective of this study is to obtain preliminary efficacy and safety data on the use of     the LivSure System (now called the Eclipse™ System) in women with fecal incontinence.   "
124548|NCT01655485|"     The purpose of the research is to test the effectiveness of the social story intervention     delivered using the iPAD application Going to Imaging on the anxiety, challenging child     behaviors, child injuries and completion rates among children with ASD undergoing medical     imaging procedures. A secondary purpose is to test the effect of this intervention on the     anxiety levels of the parents of ASD children undergoing medical imaging procedures.      Hypotheses:      H1: Children with ASD who are exposed to a story book Here the investigators go to medical     imaging (x-ray) to prepare for medical imaging compared with children with ASD exposed to     treatment as usual (TAU) will have:        1. Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline          compared to up to two hours later).        2. Exhibit fewer challenging behaviors as measured by a behavior observation scale          (developed for the study (up to 2 hours after baseline)        3. Higher procedure completion rate.        4. Shorter time to complete a procedure.        5. Less child injuries.           H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of          children with ASD who are exposed to a story book Here the investigators go to medical          imaging (x-ray) to prepare for medical imaging will have:        6. Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).   "
124549|NCT01655472|"     Schizophrenia is a common disorder with a lifetime prevalence of about 1%.Genetic studies     strongly suggest a genetic component to the inheritance of schizophrenia. Structural     neuroimaging studies have provided consistent evidence for brain abnormalities in     schizophrenia. The timing of brain abnormalities in schizophrenia has not been determined     yet.      The investigators hypothesize that brain structural changes can be detected in neonatal life.     The investigators hypothesize that offspring of schizophrenic patients will have higher rates     of brain structural changes in the neonatal period. The investigators propose to study early     development of fetuses in offspring of patients with schizophrenia. The study is a     multi-center prospective trial.   "
124550|NCT01655459|"     Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA     fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA     malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of     esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then     reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA     position, but the rotated degree of LMA was not considered in that grading. We hypothesized     that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be     detected on ultrasound. This study was designed to assess the predictability of the rotated     LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.      Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to     this study. Ultrasound was performed on supraglottic and vocal cords area before and after     LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was     evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade >3 was     showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to     one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre-     and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of     rotation were measured.   "
124551|NCT01655446|"     The purpose of this proposal is 1) to compare the relative effects of the robotic     rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare     the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the     RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will     potentially influence the functional outcomes after interventions.   "
124552|NCT01655433|"     This study will look at the safety of treating patients with heart attack with mild     hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the     Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and     with adequate performance.   "
124553|NCT01655420|"     This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related     quality of life (QoL) of 300 civilian participants prior to and three months following     state-of-the-art laser in situ keratomileusis (LASIK).   "
124554|NCT01655407|"     The purpose of this research study is to test how well the investigational treatment,     Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.      The areas of the body that are treated with ESS-W will be compared to similar areas treated     with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will     be performed by taking healthy skin from one area of the body and placing it on the burned     area.   "
124555|NCT01655394|"     IVIg exert a variety of different immunomodulatory effects and several mechanism of action     have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in     patients with immune-mediated neuropathies will be explored.   "
124556|NCT01655381|"     This open-label, single arm, multicenter long-term extension study will evaluate the safety     and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe     rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible     participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104     weeks.   "
124557|NCT01655368|"     This multi-center, 2-arm interventional study within different mental health care settings     (psychiatry: in-patient, day-unit and out-patient, as well as psychiatric rehabilitation)     evaluates a psychotherapeutic group intervention to improve stigma coping and empowerment     using a psychotherapeutic module embedded in a psychoeducational group therapy.   "
124558|NCT01655355|"     Between the years 1999-2011 70 patients went through a revision of the hip joint(revision     after not successful Total or Partial Hip Replacement). During the revision the Acetabular     implant was found to be stable and it was decided not to replace it. The polyethylene insert     was replaced and was fixated using a cement. Our purpose is to evaluate the physical     condition of these patients.   "
124559|NCT01655342|"     Clinical and radiographic assessment of Biodentine® as a pulp dressing material for pulpotomy     treatment in human primary molars.   "
124572|NCT01655173|"     The purpose of this study is to determine if adults with autism spectrum disorder and with     normal intelligence improve from 36 sessions (1 calendar year) of group treatment with     Cognitive Behavioural Therapy or recreational activity in groups with 6-8 participants.   "
124560|NCT01655329|"     This is a study to determine whether or not a new type of software is, or is not, of benefit.     The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect     tubes, lines and wires that may be placed within a patients chest. These types of devices are     commonly used for very sick patients in intensive care units and are also used following     surgery and in the treatment of cancer. This study will test radiologist's detection of the     tips of these devices comparing the results with standard chest radiographs and the the     modified chest radiographs. The primary interest is in the time used to interpret the     radiograph. We will determine if there is any change in accuracy of detection.   "
124561|NCT01655316|"     PSVT is a common rhythm disorder in emergency department which can be recurrent in some     cases.      Intravenous Adenosine is the drug of choice in PSVT control in acute settings but is a very     short acting agent.      Providing a complementary medication to decrease the rate of recurrence of PSVT after its     initial control will be promising.      This study evaluates the role of the oral Verapamil in recurrence control of PSVT in     emergency situations.   "
124562|NCT01655303|"     Rate control in atrial fibrillation is a usual battle in emergency departments. Oral     medications have a natural superiority to intravenous ones because they are easy-to-use and     decrease the workload in busy emergency departments.      This study wants to find an effective oral medication for rate control in rapid ventricular     response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are     compared in patients with a stable hemodynamic status.   "
124563|NCT01655290|"     This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate     dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed     enhancement cardiac Magnetic Resonance Imaging   "
124564|NCT01655277|"     Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength,     thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve     block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC)     of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes     included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment of     fall risk with the Berg Balance Scale (BBS) at 30 minutes.   "
124565|NCT01655264|"     The overall goal of the study is to evaluate the clinical effectiveness of a home-based     tele-motion-rehabilitation (TMR) program in improving functional status of people who had     stroke. We hypothesize that the clinical effectiveness within a mock-up set up in the     hospital of the TMR will be greater in comparison to self-training exercise carried out at     home in improving outcomes of Range of Motion and functional performance of the weak upper     extremity.      Twenty-four subjects who had a stroke, aged between 18 and 80 years, and living at home will     participate. Subjects will be 2-72 months post stroke, and no longer receiving rehabilitation     as in or out patient. They will have moderate impairment of the affected upper extremity     determined by range of motion (ROM). Subjects will be evaluated for motor and cognitive     abilities for a total of 5-6 hours by a skilled therapist who will be blind to group's     assignment of the subjects. The evaluations will be repeated 3 times, once before the     intervention commences, once immediately following the intervention and once four weeks after     the intervention.      Subjects will be randomized into the two groups (TMR versus self-training treatment) with     matching for level of impairment of the upper extremity by a person who is not part of the     study. Each subject will receive twelve 45-60 min sessions over 4 weeks while seated. The     control group will receive self-training exercises that are based on conventional therapy     using principles of motor control and will include training of upper extremity movements in     order to achieve better use of the affected arm in ADL. The experimental group will receive     TMR treatment of comparable duration and intensity to those in the conventional treatment     group with remote online monitoring by the therapist. Treatment feedback will be given in the     form of Knowledge of results (game scores) and Knowledge of performance (feedback of     compensatory movements made while using the upper extremity) to enhance motor learning. The     software will generate a report which will include the duration and type of exercises     performed by the subject.      The Gertner TMR system is implemented via Microsoft's Kinect three-dimensional) camera-based     gesture recognition technology. Using the patient's natural hand and body movements control     all activity within customized computer games. The system runs off a standard desktop     computer and is displayed on a large television screen.   "
124566|NCT01655251|"     To evaluate the effect of video discharge instructions on return visits to the ER or ED     within 72 hours of the original visit for children with febrile illnesses.   "
124567|NCT01655238|"     The investigators are concerned about anesthetizing obese children in outpatient locations in     case they need prolonged stay, increased respiratory interventions, or need for     post-operative narcotics. The investigators will be using a screening guideline to help us     determine the higher risk child based on BMI and co-morbid conditions. The investigators will     also be doing a retrospective chart review of 300 patients with BMI 95% and looking at     various factors during the operative and post-operative period.   "
124568|NCT01655225|"     The purpose of this study is to find a recommended dose level and schedule of dosing     LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The     study will also explore the changes to various markers in blood cells and potentially tumor     cells. Finally, the study will help document any antitumor activity this drug may have.      In Part A of this study, participants with advanced/metastatic cancer (including lymphoma)     will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in     different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.   "
124569|NCT01655212|"     The objective of the trial is to investigate whether early treatment with oral valganciclovir     of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can     prevent progression of hearing loss.   "
124570|NCT01655199|"     During the previous phases of the project (Phase I and II), two new field tests have been     designed and validated for an integration in a primary care setting in Chronic Obstructive     Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min     paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted,     particularly by the reduction of dyspnea level following bronchodilatation, Phase II     highlight that the 3MPST does not allow to detect this decrease of dyspnea after     bronchodilatation. The use of too high step rates could explain these results through a     hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial     is to follow the investigations on the sensitivity of 3MPST to detect the effects of     pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of     this work is that the use of lower step rates cadences could allow to detect an improvement     of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step     rates.   "
124571|NCT01655186|"     This multicenter, randomized, double-blind, placebo-controlled Phase 2 safety study will     assess the effect of bardoxolone methyl relative to placebo on body weight and fat mass in     approximately 60 patients with stage 4 Chronic Kidney Disease (CKD) and Type 2 Diabetes     Mellitus (T2DM).   "
124574|NCT01655147|"     The purpose of this study is to assess the effects of repeated daily administration of     rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone     following single-dose administration of abiraterone acetate tablets in healthy male     participants.   "
124575|NCT01655134|"     The telemonitoring systems for congestive HF did not yet prove their efficacy despite initial     encouraging results. Decongestion is one of the main objectives in Congestive HF, but an     appropriate titration of diuretics is warranted, since long-term use of diuretics was     consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et     al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic     effects, as assessed by an estimated plasma volume depletion, in addition to     potassium-sparing properties, independently from renal function variations. These three     parameters were independently associated with patient outcomes and may therefore be potential     monitoring/and therapeutic targets in patients with congestive HF.      Main objective :      To assess the variations of estimated plasma volume, serum potassium and estimated glomerular     filtration rate after an hospitalization for decompensated HF, by using a home-based finger     capillary punction for 5 consecutive days per week during the two months postdischarge, using     an approved dedicated device (ABOTT iSTAT).      Secondary objectives :        1. to assess the correlations between plasma volume, serum potassium and estimated          glomerular filtration rate variations (as measured by Istat, and by a weekly venous          punction) and body weight, home blood pressure measurement, dyspnea self assessment          variations.        2. bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis   "
124898|NCT01650870|"     The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline     lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the     physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale     (BBPS).   "
124576|NCT01655121|"     Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune     response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and     liver failure.      There are few studies on dietary management in hepatitis and most of theme have focused on     micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of     other diseases associated, but few recommendations have been made regarding a complete     dietary approach. Fiber has been proven to increase the excretion of nitrogen products and     consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to     decrease endogenous catabolism in cirrhotics patients.      The implementation of a high protein high fiber nutrition plan and improves nutritional     status of patients with autoimmune cirrhosis.   "
124577|NCT01655108|"     This study aims to investigate the effectiveness and safety of mesotherapy for the treatment     of female pattern alopecia.        -  Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss          will undergo mesotherapy sessions weekly for ten weeks.        -  One group will receive 0.5%/2ml minoxidil application and a control group will receive          application of placebo (saline 0.9%).        -  Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before          and 08 weeks after treatment as a method objective evaluation of the response   "
124578|NCT01655095|"     Colon capsule endoscopy is a technology that has been developed as a noninvasive method of     examining the large bowel. The biggest limitation to its use has been finding a bowel     preparation that will both clean the colon adequately for good visualization of the mucosa     and also help propel the capsule through the colon. Most studies have been conducted in     Europe using bowel preparation medications that are not approved for use in North America.      The purpose of this study is to compare a combination of polyethylene glycol (PEG) and     prucalopride to Picosalax and prucalopride to determine which regime will give a better colon     cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used     routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for     use in Canada which improves intestinal motility and should help with colon capsule transit.      Patients who are being referred for colonoscopy will be enrolled in the study and randomized     to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation     with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel     preparation, patients randomized to the Picosalax group will take dulcolax three nights     before the test and then again two nights before the test. The evening before the test     patients will take either PEG 2L or one sachet of Picosalax. The following morning they will     take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will     then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they     will return to the endoscopy unit where they will undergo a colonoscopy, which is the     standard of care for examination of the colon.      The images from the colon capsule will be reviewed and the quality of bowel preparation will     be graded using a previously validated scale. It is hypothesized that the Picosalax and     prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as     there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp     detection and abnormalities of the mucosa detected with the colon capsule will also be     compared to polyps and abnormalities detected at the time of colonoscopy.   "
124579|NCT01655082|"     The purpose of this study is to evaluate the safety profile of a repeated application of a     new transdermal patch compared to a reference product during 3 weeks, in a large population.   "
124580|NCT01655069|"     This is a 40-week study to investigate how safe and effective solifenacin solution is in     treating children/adolescents with symptoms of overactive bladder (OAB) who completed study     905-CL-076. To measure the efficacy of the treatment the patient will complete a 7-day     patient diary prior to every visit, starting at Visit 9. The patient will attend the study     clinic on 7 separate occasions. The first visit of this study (905-CL-077) will be combined     with the last visit of the 4-month study 905-CL-076. At each visit, the patient will be     required to undertake a number of assessments or examinations to determine whether it is safe     for him/her to take part or to continue to take part in the study. During the first 3 visits     the dosage of the study drug will be adjusted if needed in order to optimize the most     effective and safe dose for each patient.   "
124581|NCT01655056|"     The study aims to investigate the effect of YM150 and to compare gender and ethnic     differences in healthy Caucasian and Japanese male and female subjects.   "
124589|NCT01654926|"     Ultrafiltration (UF) technology is unique for its ability to extract fluid as an isotonic     solution, therefore not causing substantial changes in NaCl concentrations, and the use of     peripheral veins makes it feasible to use in out of hospital medical centers, for non     compensated Heart Failure (HF) with a low response to diuretics. The use of UF in the United     States and Europe in out of hospital HF centers is accepted as daily practice. Therefore the     hypothesis of this study is that it is feasible for a professional team to effectively use     the UF for short courses on non compensated HF patients with low or no response to Diuretics,     in a dedicated out of hospital HF center.   "
124590|NCT01654913|"     This study examines the effect of oxygen supplementation on the non-invasive measurement of     hemoglobin.   "
124582|NCT01655043|"     Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the     U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery     disease that is considered most accurate is coronary angiography however it involves risk and     radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi     qualitative analysis of the myocardial perfusion images.      In this proposal the investigators will develop a means to calculate Coronary Flow Reserve     (CFR) using the MRI. the investigators approach has the potential to reduce mortality from     myocardial infarction by effecting a change in the patient management paradigm. Absolute     quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with     more accuracy than the semi-quantitative or qualitative analysis of perfusion images.     Measurement of Coronary Flow Reserve is important for the following reasons: decrease of     coronary flow reserve has been identified as a first effect of CAD; it provides an objective     measure of treatment efficacy.      The purpose of this study is to compare images from nuclear stress test and/or coronary     angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary     artery disease calculating myocardial blood flow using a novel MRI technique combined to an     extracellular Gadolinium-based contrast agent and stressor agent   "
124583|NCT01655030|"     The purpose of this study is to determine whether creatine monohydrate is effective as an     adjuvant treatment for bipolar depression.   "
124584|NCT01655017|"     Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis     amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose     biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive     tools to measure fibrosis needs to be validated. The investigators primary aim is to validate     a new device able to measure adipose tissue stiffness.      Thus the investigators plan to compare the stiffness results obtained with the device to the     quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to     a bariatric surgery.   "
124594|NCT01654861|"     -  The combination of gemcitabine and HDIVC is safe and may favorably change the clinical          course for an individual patient.        -  The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in          preclinical models, where HDIVC creates a pro-oxidative effect that adds to the          anti-tumor effect of gemcitabine.        -  The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).        -  The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg          infusion may create sustained elevation in Vitamin C plasma levels for increased          cytotoxic effect.        -  The addition of HDIVC & oral supplementation of Vitamin C to standard treatment with          gemcitabine may improve quality of life for patients with comparison to prior to          treatment start of this protocol.        -  CA 19-9 and inflammatory markers may show trends for patients in this trial.   "
124585|NCT01655004|"     Aromatase inhibitors have led to significant improvements in clinical outcomes for women with     postmenopausal hormone receptor-positive advanced breast cancer. However, there is a notable     absence of phase III comparisons among the three agents and therefore no clear indication of     the superiority of one AI over the others. Furthermore, there remains a distinct lack of     predictive biomarkers of AI efficacy and toxicity to inform clinical decisions. The metabolic     pathways of exemestane have recently been delineated and UGT2B17 is the most active hepatic     gluconoryltransferase responsible for the glucuronidation of the crucial active exemestane     metabolite, 17-dihydroxyexemestane. The UGT2B17*2/*2 deletion genotype is associated with     markedly reduced glucuronidation of 17-dihydroxyexemestane in vitro and is found more     commonly in Asians than Caucasians (60-70% vs less than 10%). Our research group recently     demonstrated significant reduction in glucuronidation of vorinostat, a UGT2B17 substrate,     with a trend towards improved clinical benefit rate and progression-free survival in Asian     breast cancer patients who were UGT2B17*2 homozygotes treated with this compound. In-vivo     studies correlating UGT2B17*2 genotype with exemestane pharmacokinetics and pharmacodynamics     are lacking. We hypothesize that individuals with UGT2B17*2/*2 genotype have reduced     glucuronidation of 17-dihydroxyexemestane and therefore have increased exposure to the active     drug, resulting in improved treatment efficacy. We propose a study of exemestane in hormone     receptor positive post-menopausal advanced breast cancer patients with prospective     correlation of treatment outcome by UGT2B17 genotype. The primary endpoint is the correlation     of genotype (UGT2B17*2/*2 vs those with at least one wild-type variant) with clinical benefit     rate, and secondary endpoints include its association with exemestane pharmacokinetics,     progression-free survival, overall survival and musculoskeletal toxicities.   "
124586|NCT01654991|"     This study randomizes St. Louis men to home-based STD screening or clinic-based STD     screening. Home-based screening will be completed through the mail and clinic-based screening     in a local clinical setting. We hypothesize that men randomized to home-based screening will     be more likely to complete screening.   "
124587|NCT01654965|"     This phase I trial studies the side effects and best dose of tivantinib and topotecan     hydrochloride in treating patients with advanced or metastatic solid tumors. Tivantinib and     topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
124588|NCT01654939|"     For HIV-infected patients who have access to treatment, liver diseases are a major cause of     morbidity and mortality. Hepatitis C is the most frequently encountered liver condition in     this population. Both diseases allow a higher level of poisonous substances (toxins) normally     produced by the bacteria present in the gut to enter the bloodstream. This leads to a chronic     inflammatory state, which results in faster development of liver scars (fibrosis) and     ultimately, end stage disease (cirrhosis). To prevent this from happening, the use of     antibiotics has been attempted to reduce the quantity of gut flora in the hopes of lowering     the amount of toxins produced. These trials have shown promising results, but the antibiotics     studied had major side effects and were not designed for continuous use. Rifaximin is a non     absorbable antibiotic with very few side effects. It is already used for long periods of time     in cirrhotic patients to treat the effects of cirrhosis on the brain (encephalopathy). This     project will try to determine if rifaximin, by reducing the level of toxins produced by the     bacteria in the gut, can improve the evolution of liver fibrosis in HIV-infected patients     with hepatitis C. In this pilot study, ten patients with HIV and HCV infection will be     followed for one year. In addition, 10 patients with HCV mono infection will also be     followed. Both populations will be included if they are starting on rifaximin, for its     currently approved FDA indication (hepatic encephalopathy).   "
124591|NCT01654900|"     The purposes of the investigators study is to examine the overall survival and quality of     life in elderly patients (> 75 years) undergoing open heart surgery at Hadassah medical     center between 2008-2011. All alive patients will be phone interviewed using the 36-item     short form health survey. Results will be compared to similar health survey results     (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled     group). The investigators hypothesize that elderly patients achieve improvement in quality of     life after open heart surgery with acceptable operative morbidity and mortality.   "
124592|NCT01654887|"     The primary objective of this study is to determine if lung ultrasound (LUS) can replace     chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, we are     looking for an overall reduction of CXR when LUS is used first. Our null hypothesis is that     LUS cannot replace CXR for diagnosing pneumonia. Our alternate hypothesis is that LUS can     replace CXR for diagnosing pneumonia. Our secondary objectives include: (1) a comparison of     unscheduled healthcare visits after the index Emergency Department (ED) visit between those     subjects who undergo CXR first and those who undergo LUS first, (2) an evaluation of the rate     of antibiotic use between the two groups, (3) a comparison of the admission rates, and (4) a     comparison of the length of stay in the Emergency Department between the two groups.   "
124593|NCT01654874|"     This trial is a single-blind, cross-over design. Up to three patients with confirmed     metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses     of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation     B). Whole-body planar scintigraphic images will be acquired at various time points on the day     of study drug administration. A pelvic SPECT/CT image will be acquired on the day of study     drug administration. Blood will be collected for pharmacokinetic measurements following study     drug administration. Each participant will receive an initial study drug administration     (preparation A) and a second study drug administration (preparation B) approximately 7 to 21     days later. A final follow-up visit will occur approximately 2 - 3 weeks after the second     study drug administration.   "
124595|NCT01654848|"     In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT)     Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological     findings in thrombocytes and anti-body patterns is going to be investigated.   "
124899|NCT01650857|"     Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC)     and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient pulmonary     rehabilitation (PR) improves PC, BC and HRQOL.   "
124596|NCT01654835|"     The investigators thus propose to use an innovative randomized effectiveness trial design to     test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡±     clinical condition and decision-support alerts will prompt earlier hemodynamic support and a     consequently reduce the duration of such conditions. Specifically, the investigators will     test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration     of hypotensive episodes. The core of the investigators study will be an existing electronic     anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at     Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned     to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within     three minutes after detection. Clinicians will be free to act on the alert, ignore the alert,     or to consider the provided information without acting on it. The randomization, complete     anesthesia record, detailed record of hypotensive events, alerts provided, clinician     responses, and SAP response, will be captured by the investigators electronic record-keeping     system. The investigators primary outcome will be the duration of time the patient has a     systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of     hospitalization. The investigators will assess the effect of the alert on the primary outcome     of time to SBP returning to above 80 mmHg using survival analysis, with time to event     censored (and considered a non-event) at either the end of surgery or end of monitoring if     patient did not return to above 80 mmHg.   "
124597|NCT01654822|"     This study aims to prove that, by a one-time topical spray on the cervix, AV2-DM is an     effective antiviral in reducing on short term (3 months) the human papillomavirus (HPV)     infection.        -  Primary endpoint: significant drop in viral load AV2-DM versus placebo        -  Secondary endpoint:the number of patients with adverse events   "
124598|NCT01654809|"     The purpose of this study is to observe the adverse reaction ratio and hemagglutination     inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split     influenza virus vaccine in different population.   "
124599|NCT01654796|"     This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for     treating patients with treatment resistant depression who are taking an antidepressant that     is not working for them.   "
124600|NCT01654783|"     The objectives of this study are to investigate how oral 5-ASA drugs have been used in the     condition without symptoms such as abdominal pain or diarrhea/bloody stool (remission stage),     or in the transition from the condition with symptoms such as abdominal pain or     diarrhea/bloody stool (active stage) to the remission stage in ulcerative colitis and to     study how many patients will be able to maintain the remission stage during the observation     period and how many times the patients will experience the active stage (relapse), as well as     how symptoms will change during the observation period to discover better treatment plans.   "
124601|NCT01654770|"     Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with     significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The     mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a     meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in     patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this     meta-analysis study was that the included studies examined patients with occult OGIB and     overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a     significant lesion that causes a recurrent bleeding which subsequently increases risk of     morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB,     patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE     in a diagnosis tool with an impact on clinical management.4-7 Although previous studies     showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE     first in patients with massive overt OGIB is still uncertain. Thus in this study, we     conducted the prospective study to compare urgent VCE with urgent DBE in patients with     massive overt OGIB.   "
124626|NCT01654419|"     THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND     MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS   "
124627|NCT01654406|"     Fractional CO2 laser can improve the Cesarian scar   "
126030|NCT01635439|"     The purpose of the study was to compare the safety and efficacy of two agents used in     induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2     (Dinoprostone vaginal Tablet).   "
124602|NCT01654731|"     Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease that eventually leads     to end-stage liver failure and death unless liver transplantation (LT) is performed.     Ursodeoxycholic acid (UDCA) administered orally at the daily dose of 13-15 mg/kg is currently     the only drug approved for the treatment of PBC. UDCA consistently improves biochemical liver     tests, prolongs survival without LT, and delays histological progression as well as the     occurrence of portal hypertension. However, a significant proportion (40%) of patients     treated with UDCA shows an incomplete biochemical response and remains at high risk of death     or LT. The development of new treatments in combination with UDCA is therefore needed.     Several candidates exist among which is Bezafibrate. Bezafibrate belongs to the fibrates'     pharmacological class, which has been developed 4 decades ago for the treatment of mixed     hyperlipidaemia. Bezafibrate is cheap, widely available and well tolerated. There is now a     substantial body of circumstantial evidence supporting that fibrates, and Bezafibrate in     particular, are well tolerated and can improve biochemical liver tests in patients with PBC     with incomplete response to UDCA. However, despite several positive successful pilot studies,     there are still no phase 3 randomized placebo-controlled trials of fibrates for the treatment     of PBC. The purpose of this protocol is therefore to conduct such a trial in a selected     population of patients with PBC based on an incomplete biochemical response after 6 months of     UDCA therapy.   "
124603|NCT01654718|"     This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg     delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is     equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy     Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of     Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of Wyeth     Laboratories, USA in healthy, adult, human, male subjects under fed conditions.   "
124604|NCT01654705|"     This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg     delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent     to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy     Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of     Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of Wyeth     Pharmaceuticals Inc., USA in healthy, adult, human, male subjects under fasting     conditions.condition.   "
124606|NCT01654679|"     The purpose of this study is to dermine whether local-water filtered infrared-A (wIRA)     irradiation can reduce postoperative wound infection. wIRA irradiation is applied 20min     directly preoperatively, before patients underwent abdominal surgery. The wIRA is a harmless     light source, that has been described before. We test the impact and clinical outcome of     patients undergoing a one-time preoperative wIRA irradiation on postoperative wound healing.   "
124607|NCT01654666|"     Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory     effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the     investigators will use clinical outcome, serum biochemical markers and brain magnetic     resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory     effects on patients undergoing carotid artery stenting.   "
124608|NCT01654653|"     The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown     that colloid is better as compared to crystalloids. Several previous studies have     demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows     a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL     with 6% Hydroxy Ethyl Starch (HES).   "
124609|NCT01654640|"     The purpose of this study is the evaluation of effect of metformin on obesity and metabolic     disturbance in patients taking clozapine.   "
124610|NCT01654627|"     The purpose of this study is to examine the safety and usefulness of the Regenecure guided     bone regeneration membrane for stimulating bone growth in patients that don't have enough     bone for dental implant placement. The study will include 16 patients in each group, 20     non-smokers and 12 smokers, a total of 32 patients will participate in the study.   "
124611|NCT01654614|"     Primary objective of this study was to evaluate the diagnostic capability of keratoconus     match index (KMI) and keratoconus match probability (KMP) indexes in forme fruste keratoconus     (FFK), and their association with a series of Pentacam-derived keratconus (KC) indexes. KMI     and KMP parameters are KC-specifc indexes that are measured by Ocular Response Analyzer     (ORA), based on the distinct ORA-derived waveform characteristics of KC eyes.      Study participants were recruited from the Cornea Outpatient service in a consecutive if     eligible basis. Two study groups were formed: a) FFK group (FFKG) that included patients     diagnosed with FFK, and, b) Control group (CG) was formed by refractive surgery candidates.      All ORA (Reichert Ophthalmic Instrument, Buffalo, NY, USA, software version: 3.01)and     Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were     performed by the same experienced operator in a consistent way   "
124612|NCT01654601|"     To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.   "
124613|NCT01654588|"     Bronchial challenge tests (BCT) are being used to diagnose bronchial hyperactivity (BHR) and     quantify its severity.In older children and adults, BCT is done using spirometry to measure     the value of 20% fall in FEV1 as an indicator for positive reactivity.      However, in young children and infants that cannot perform spirometry, other measurements are     used as indicators for BHR. Traditionally, in these populations, appearance of wheezing on     auscultation is used as the indicator for BHR. More recently, other measures like 50%     increase in respiratory rate or 5% decreases in oxygen saturation are mentioned as possible     options to determine positive BHR. Nevertheless, as these measurements probably measure     different parameters they could vary in time of appearance.      The investigators also noted that in older children who perform spirometry, the order of     appearance of these different physiologic measures is not constant.      Decrease in O2 saturation, appearance of wheezing and increase in respiratory rate (RR) do     not all appear at the same time and not in the same order of events.      Some children are noted to have a decrease in FEV1 without wheezing - those children can be     difficult to diagnose as asthmatics in the primary care setting where asthma is being     diagnosed on clinical grounds alone: wheezing and response to bronchodilators. Children who     do not wheeze are difficult to diagnose and therefore, are not getting the appropriate     treatment.      Nevertheless, the data in current literature is very scant or not existing regarding these     issues. Thus the investigators designed a study to prospectively try to answer the questions:     do clinically significant differences exist in the concentration of the metacholine and / or     adenosine at the time time of appearances of these parameters, what comes first, and if so,     how does it affect the diagnosis and the severity assessment of HRA in different age groups?   "
124651|NCT01654094|"     The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the     Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in     burn wounds resulting from thermal burn injuries.   "
124614|NCT01654575|"     Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently     exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to     decrease synovitis in many inflammatory joint diseases, particularly rheumatoid     arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in     decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic     criteria of primary knee OA with knee pain, were included in this study.Patients meeting the     eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral     MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and     secondary outcome measures included improvements in physical function scores.There was a     statistically significant reduction in pain and improvement in function in the MTX group     compared to the placebo group at 16 weeks.   "
124615|NCT01654562|"     Primary objective: To examine the short-term effects of of simvastatin on the vision on males     with choroideremia, evaluated by full-field scotopic threshold testing. The investigators     hypothesize that they will see a reversible decrease in the dark-adapted vision in     participants taking simvastatin.   "
124616|NCT01654549|"     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat     content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)     index, and anthropometric measurements (body mass index and waist circumference)in     non-diabetic subjects with non-alcoholic fatty liver disease.   "
124617|NCT01654536|"     This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the     nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered     once daily to male and female subjects 12 years and older diagnosed with PAR.   "
124618|NCT01654523|"     The goals of the study are to further design, develop, and test an awareness enhancement and     monitoring device, which will be used in the self-awareness training and general treatment of     patients with compulsive hair-pulling behaviors, or trichotillomania.   "
124619|NCT01654510|"     The goal of the proposed research is to design and develop a culturally appropriate,     vocationally focused, sustainable, cognitive-behavioral intervention for unemployed,     economically disadvantaged, urban-dwelling persons whose job attainment efforts have been     undermined by the presence of social anxiety disorder.   "
124720|NCT01653197|"     The mailer will encourage those who are due for mammograms, colonoscopies, blood pressure or     cholesterol tests to receive the appropriate test. This particular mailer will only be sent     to Evive clients in need to the test in question. The research will examine differences in     follow-through on this recommendation among the targeted population over the 3-12 month     period following the mailing as a function of experimental condition.   "
124620|NCT01654497|"     The purpose of this study is to try to determine the maximum safe dose of dexanabinol that     can be administered to people with brain cancer. Other purposes of this study are to:        -  find out what effects (good and bad) dexanabinol has;        -  see how much drug gets into the body by collecting blood and cerebrospinal fluid for use          in pharmacokinetic (PK) studies;        -  learn more about how dexanabinol might affect the growth of cancer cells;        -  look at biomarkers (biochemical features that can be used to measure the progress of          disease or the effects of a drug).   "
124621|NCT01654484|"     The purpose of this study is to investigate the safety and efficacy of up to three     concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as     monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in     subjects with primary open-angle glaucoma or ocular hypertension.   "
124622|NCT01654471|"     The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in     patients with peripheral arterial occlusive disease.   "
124623|NCT01654458|"     There is a high prevalence of sexual and body image problems among women treated for     gynecologic cancer, which can lead to considerable distress. Given the sensitive and highly     personal nature of these problems, women are often reluctant to speak to their doctors about     these concerns and have few resources for support and information. The research team will     conduct a prospective randomized controlled trail (RCT) to test the benefits of GyneGals, a     12-week online (i.e. Internet-based) support group intervention for women who are sexually     distressed due to gynecologic cancer and its treatment.      The primary aim of this study is to determine whether a professionally-facilitated,     information-rich, online support group is beneficial for women who are sexually distressed     due to gynecologic cancer and the side effects of treatment.   "
124624|NCT01654445|"     This trial will enroll patients that have been diagnosed with a transient ischemic attack     (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a     minor stroke faces the possibility of long-term disability and even death, regardless of     treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or     worsen over the hours or days immediately following a stroke. The purpose of this research     trial is to study the effects of a clot-dissolving drug, tenecteplase (TNK-tPA), as a     treatment for patients who arrive within twelve hours from stroke onset. This study is     attempting to see if TNK-tPA given through a vein in the arm (intravenous) to patients is a     safe treatment for stroke patients. Neither the safety nor the effectiveness of this     treatment has been proven yet.      This trial will be conducted at several site in Canada.      Dr Michael Hill and Dr. Shelagh Coutts are the Principal Investigators of this trial,     coordinated at the University of Calgary, Foothills Medical Centre.   "
124625|NCT01654432|"     General anesthesia and morphine based pain medicine analgesia has been the mainstay of     practice in breast cancer surgery at Women's College Hospital. There is evidence to suggest     that patients have a better recovery, with less pain and nausea and vomiting when nerve     blocks or freezing of nerves are given in addition to a general anesthetic. Specifically for     breast cancer surgery, evidence has suggested that the use of paravertebral blocks provide     patients with a better quality of recovery after surgery. The aim of this study is to examine     whether patients who receive the nerve blocks using an ultrasound machine in addition to     general anesthesia have a better quality of recovery than patients who receive a general     anesthetic alone. The hypothesis is that patients receiving ultrasound-guided paravertebral     blocks (PVB) with propofol-based general anesthesia (GA) will have a better quality of     recovery than patients receiving general anesthesia-opioid-analgesia. Quality of recovery     will be assessed using a modification of the QoR-27, a validated instrument to assess     postoperative recovery in an ambulatory surgical population.   "
124628|NCT01654393|"     The purpose of the study is to help doctors in emergency departments know whether triage     nurse initiated radiographs, in accordance to the Ottawa ankle rule, before emergency     physician assessment will shorten emergency patients' visit. The investigators will examine     the number of missed fractures between the two groups, the emergency physicians' willingness     to apply OAR and triage nurses' satisfaction.   "
124629|NCT01654380|"     LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.     This study is designed to understand how the body handles the investigational drug, what     effect this investigational drug has on the body and how much should be given. This study     will also measure how much of the investigational drug gets into the blood stream and how     long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in     healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus     (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including     screening. Screening will be performed within 30 days of the start of the study.   "
124630|NCT01654367|"     Select patients of primary breast cancer whose hormone receptor is positive and accepted     postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with     zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase     treatment. Assess the disease-free survival; overall survival; combination of security, as     well as the situation of bone loss.   "
124631|NCT01654354|"     Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide     768.86mg) in abdominal CT   "
124632|NCT01654341|"     The MID-Frail STUDY project focuses on the use of interventions designed to improve     functional status and enhance quality of life (rather than traditional treatments such as     glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing     frailty and its progression to adverse outcomes.   "
124633|NCT01654328|"     The purpose of this study is to investigate if home-hydration is a non inferior alternative     for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk     patients.   "
124721|NCT01653184|"     The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with     age-related macular degeneration.   "
124722|NCT01653171|"     The purpose of this study is to determine whether premedication with Simethicone or     Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy.   "
124634|NCT01654315|"     Of the 5.7 million stroke survivors in the United States, up to 80% exhibit significant     weakness in one arm (called hemiparesis). This devastating impairment undermines     performance of valued activities and quality of life. Although rehabilitation is commonly     provided, conventional affected arm rehabilitative strategies have negative evidence, or no     evidence, supporting their use. Thus, there remains a need for evidence-based rehabilitative     strategies for arm hemiparesis.      Newer rehabilitative approaches emphasize repetitive, task-specific practice (RTP)     incorporating the affected arm. However, many of these promising regimens require     participation in intensive therapies, and most are only efficacious on the least impaired     patients. Thus, there remains a need for an efficacious, practical RTP technique to address     moderate affected arm hemiparesis.      To address the above shortfalls, one of the investigators team members piloted an innovative     brace integrating electromyography (EMG) and robotics. In his case series, 8 stroke patients     exhibiting moderate arm impairment successfully participated in RTP, with the brace (called     the Myomo) detecting and augmenting their movement attempts. Aided by the Myomo,     participation in the RTP regimen reduced subjects' affected arm impairment and spasticity.     The next logical step is to test Myomo + RTP efficacy using randomized controlled methods and     an appropriate sample size.   "
124635|NCT01654302|"     Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number     of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this     condition. This study examines a different topical approach, utilizing a topical anesthetic     agent, to evaluate if application of such an agent would provide relief of exercise-induced     knee pain in people with knee OA.   "
124636|NCT01654289|"     The primary goal of this project is to determine whether behavioral training in mindfulness     meditation or moderate intensity sustained exercise will lead to reductions in acute     respiratory infection (ARI) illness, such as common cold and influenza like illness.     Specifically, this project aims to:        1. Determine whether an 8-week training program in mindfulness meditation, as compared to          the control group, will lead to significant reductions in incidence, duration, and          severity of ARI illness.        2. Determine whether an 8-week training program in moderate intensity sustained exercise,          as compared to the control group, will lead to reductions in incidence, duration, and          severity of ARI illness.        3. Assess whether any observed reductions in ARI illness are accompanied by fewer          ARI-related health care visits and less time lost to productive work (reduced          absenteeism).        4. Compare the potential benefits of mindfulness meditation to those from moderate          intensity sustained exercise.        5. Discern potential mediating factors and causal pathways that might help explain how          these interventions lead to improved ARI illness-related outcomes.      The investigators' preliminary findings suggest substantial benefit of these interventions in     terms of reduced incidence, duration and severity of ARI illness, with corresponding     reductions in days of work lost to illness. If the proposed research confirms these findings,     there will be major implications for public and private health-related policy and practice,     as well as for scientific knowledge regarding health maintenance and disease prevention.   "
124637|NCT01654276|"     This study is being done to evaluate whether the medication, febuxostat, can improve the     degree of insulin resistance and other features of the metabolic syndrome (high blood     pressure, elevated insulin levels, excess body fat around the waist, and/or high cholesterol)     by lowering uric acid levels in the blood.   "
124652|NCT01654081|"     The goal of this trial is to demonstrate the potential clinical benefit of irinotecan     chemotherapy in patients with a specific NSCLC phenotype, ISG15-positive. The use of     irinotecan in subjects with ISG15-positive NSCLC will be associated with an improved rate of     clinical benefit (objective response, disease stability, and time to progression) compared to     historical controls that were not previously selected for ISG-15 expression.   "
124638|NCT01654263|"     The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study     will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two     groups of participants (55 through 74 years of age). First group vaccine naïve participants     will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant     previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be     randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or     Group IIB). Blood samples will be obtained at baseline, at one month and six months     post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are     statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least     some of the vaccine serotypes among participants 55 through 74 years of age previously     vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study   "
124639|NCT01654250|"     The safety and efficacy of a chewable formulation of extended-release methylphenidate will be     studied in children with ADHD   "
124640|NCT01654237|"     The hypothesis of this study is that there will be a variety of factors influencing the     musculoskeletal complaints among workers of different sectors.      Work-related musculoskeletal disorders (WMSDs) account for more than 30% of occupational     diseases in the world. In order to organize the strategic actions that will be developed for     the prevention of MSDs, it is essential to analyze in advance the peculiar situations of the     different sectors of a workplace. The objectives of this study were to determine the     prevalence of musculoskeletal complaints among workers in a medium-sized industry by     comparing its sectors and to investigate the influence of occupational and non-occupational     factors in the increase of complaints.   "
124641|NCT01654224|"     The purpose of the study is to compare the performance of two currently available influenza     (flu) vaccines. This study will try and determine if the high dose flu vaccine provides     protection that is the same or better than that of regular dose flu vaccine. Both the regular     dose and the high dose flu vaccines are approved by the FDA for use in older adults.   "
124642|NCT01654211|"     This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous     danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on     the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.   "
124671|NCT01653834|"     This research study is being done to see if lymphocytes can be collected from patients with     high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are     cells that normally circulate in the blood and are an essential part of the immune system).     The investigators goal is to store these and give them back to the patient after radiation is     completed. This is part of a larger effort that will attempt to preserve the immune system     from the effects of radiation and chemotherapy.   "
124672|NCT01653821|"     The aim of the study is to determine safety, tolerability and feasibility of unilateral and     bilateral carotid body excision in patients with systolic heart failure and peripheral     chemoreceptor hypersensitivity.   "
124643|NCT01654198|"     When patients with psoriasis develop joint pain, it is often hard to decide whether or not     the pain is due to psoriatic arthritis (PsA). At this time, doctors use information from the     history and physical exam to determine the diagnosis. X-rays, magnetic resonance imaging     (MRI) and ultrasound have been used to help with the diagnosis but all three have     limitations. A newer imaging technique, whole body Positron Emission Tomography/Computed     Tomography (PET/CT) uses the idea that inflammatory cells take up sugar to locate     inflammation in the body. Because patients with PsA have inflammatory cells in their joints     and tendons, this type of scan allows the physician to take a picture of the whole body and     locate inflammation. The investigators have found that some patients with psoriasis (but     without arthritis) have inflammation in joints and tendons even before the patient has     symptoms. In this study, the investigators will explore how well PET/CT works for assessing     inflammation in patients with PsA. This would be a very exciting tool that could be used to     find and treat inflammation before it causes damage or pain.   "
124644|NCT01654185|"     The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic     breast cancer.   "
124645|NCT01654172|"     Cocoa flavanols form part of the family of chemicals (also found in red wine and tea) which     have aroused interest due to population studies suggesting that diets high in these     substances might reduce risks of heart disease. In the laboratory, these flavanols have been     shown to cause blood vessels to widen and blood flow to increase. As dysfunction in this     ability of blood vessels to widen is now thought to play a central role in the complications     of diabetes, novel ways to mitigate this are constantly being sought.      The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure foot     and brain blood flow before and after 7 days consumption of a cocoa drink high in flavanols,     in subjects with diabetes, with and without peripheral neuropathy.   "
124646|NCT01654159|"     The main objective of this research is to assess visual function and optical performance of     CE marked, implanted intraocular lenses to understand the individual factors that affect     their performance and how these may be improved in future designs and to evaluate measurement     techniques.      All outcome measures will be captured 3-6 months after surgery   "
124647|NCT01654146|"     The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or     carboplatin at a lower dose every week) is more effective than standard chemotherapy     (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian     cancer. The investigators also want to see if weekly chemotherapy causes more or fewer     side-effects than standard chemotherapy.   "
124648|NCT01654133|"     The purpose of this study is to evaluate visceral function, after endovascular repair of     thoracoabdominal aneurysms.   "
124649|NCT01654120|"     The purpose of this study is to determine the effect of adding liraglutide to high dose     insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated     Type 2 diabetes with insulin requirements of > 100 units of insulin per day.   "
124650|NCT01654107|"     The investigators propose to develop a theory-based smoking cessation intervention (called     Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling     sessions and use of nicotine lozenge for 12 weeks. The investigators will test the     feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and     prolonged abstinence).   "
124653|NCT01654068|"     The purpose of this study is to determine if Conformal High Dose Intensity Modulated     Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal     column. This study involves patients who have been diagnosed with metastatic cancer to the     thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the     area of concern. The goal is to prove that this is not only a safe form of treatment, but     that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer     coming back in the area that the investigators treat which may reduce the risk of developing     symptoms like pain in the future.   "
124654|NCT01654055|"     Morphine is the gold standard for treatment of severe acute pain but it has a number of     adverse effects.      No study has so far managed to identify the morphine-induced adverse drug reactions. The     primary objective of this study is to determine predictive factors of morphine-induced     adverse drug reaction when it is used in emergency departments.   "
124655|NCT01654042|"     More than 2 million patients in North America are treated with warfarin - a blood thinner -     to prevent blood clots in arteries or veins. The treatment has to be monitored with a blood     test and the dose changed accordingly every 1-4 weeks. One third of the patients have very     stable results and hardly ever have to change the dose. The investigators wish to show that     the level of control of the treatment with warfarin in these very stable patients is not     worse with 12-weekly testing. A pilot study the investigators performed indicated that     12-weekly testing would be safe but this has to be confirmed in a large study. One third of     patients taking warfarin have not had any changes in the dose for the past 6 months or     longer. These patients will be asked about participation in the study. They will be     randomized to testing and dosing every 4 or 12 weeks. Each patient is in the study until it     ends, which will be minimum 1 year and can be up to about 4 years. The study is designed to     show that 12-weekly testing does not significantly increase the risk for major bleeding or     blood clots. The results would be important for a large number of patients. An increase of     the interval between blood tests from 4 to 12 weeks would reduce the burden for these     patients on life-long treatment considerably.   "
124673|NCT01653808|"     The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio     210H dialyzer between two dialysis modalities, conventional hemodialysis and on line     hemodiafiltration.   "
124656|NCT01654029|"     The most frequent consequence of a stroke is a communication impairment. When patients cannot     articulate their needs, frustration and agitation are frequent responses, often resulting in     poor optimization of post-stroke function. Staff's lack of knowledge of communication     strategies exacerbates the problem. A key component of patient-centred care is the ability of     staff to communicate in such a way that allows them to understand the patient's needs.     Members of our team developed the patient-centred communication intervention (PCCI) targeting     registered and unregulated staff caring for complex continuing care (CCC) patients with     communication impairments post stroke. The purpose of the study is to examine if the PCCI     results in improved patients' quality of life and in improved staff attitudes and skills in     caring for patients with communication impairments.   "
124657|NCT01654016|"     Aim of the study:      To investigate if there is a differences in expression of inflammatory markers in venous wall     and blood among patients treated with Detralex and those not treated with Detralex (control     group).   "
124658|NCT01654003|"     This study wants to compared the safety and efficacy of GDTs using standard pressure-related     parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in     septic patients requiring emergency surgery.   "
124659|NCT01653990|"     A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to     assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in     healthy Chinese subjects.   "
124660|NCT01653977|"     This study compares the safety and efficacy of GDTs using standard pressure-related     parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in     trauma patients requiring emergency surgery.   "
124661|NCT01653964|"     The primary objective of this work is to determine if half-dose Molecular Breast Imaging     (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied     can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI     performed with 8 mCi Tc-99m sestamibi.   "
124662|NCT01653951|"     The results of the pre-pilot and pilot studies will be used to determine the feasibility of a     fully powered trial that will test the effectiveness of two different approaches to diabetes     management in an uninsured diabetic population who receives their care from a community based     free clinic, namely nurse-directed interdisciplinary care management compared to peer-led     self management. Effective programs for the uninsured diabetic will benefit both the     individual and society by preventing serious illness, decreasing mortality and disability,     decreasing medical debt, stimulating economic growth, improving business productivity,     reducing job lock, decreasing health disparities, improving quality of life, and reducing     cost shifting by decreasing uncompensated care. Findings will be generalizable to uninsured     and insured patients across a wide spectrum of chronic conditions.   "
124663|NCT01653938|"     This is a randomized controlled trial of a CPR video decision aid in patients with advanced     congestive heart failure (CHF).   "
124664|NCT01653925|"     The purpose of this study is to determine whether marine omega-3 fatty acids and     5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk     prostate cancer patients.   "
124665|NCT01653912|"     -  Dose-finding study of GSK2110183 administered in combination with carboplatin and          paclitaxel to any subject with recurrent ovarian cancer.        -  Safety and efficacy study of GSK2110183 administered in combination with carboplatin and          paclitaxel to subjects with platinum-resistant ovarian cancer.   "
124688|NCT01653613|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.      PURPOSE: This laboratory study is looking into genes in samples from younger patients with     acute lymphoblastic leukemia (ALL).   "
125256|NCT01645787|"     The purpose of this study is to assess whether 4-AP (Dalfampridine-ER, Ampyra) improves     walking ability and endurance in adult patients with Spinal muscular atrophy (SMA) Type 3     compared to placebo and whether the duration of treatment affects outcome.   "
124666|NCT01653899|"     This is an Investigator Initiated, Phase I/II study, where Type 1 diabetic participants will     receive a 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556     following their first islet transplant. Two pilot studies are proposed to establish the     optimal safety and efficacy dose of IDN-6556 (25 mg twice daily (Pilot 1) or a loading dose     of 100 mg two hours prior to transplantation, then two 50 mg doses following transplant (Day     0) (Pilot 2). This will be followed by 50 mg three times daily). Participants of both pilot     studies will receive islet cell transplants under the University of Alberta's     standard-of-care therapy.      Secondary objectives include:        1. To determine the proportion of subjects treated with IDN-6556 who achieve and maintain          insulin independence after the first or subsequent islet transplant.        2. To obtain preliminary data on the efficacy of IDN-6556 to maintain adequate          immunological protection against both allo- and autoimmunity of islet transplant          recipients.   "
124667|NCT01653886|"     A pilot study was conducted to develop the study menus that were similar in appearance,     aroma, and taste.   "
124668|NCT01653873|"     After vertebroplasty, many patients will suffer from 2nd fracture in the vertebral column.     With analyzing of the images done right after the 1st vertebroplasty, we can define the     parameters from different imaging and they can be predictors of the future fracture.   "
124669|NCT01653860|"     The purpose of this study is to investigate the effectiveness of the Brøset anger management     model in reducing violent behavior amongst clients who are violent in intimate partnerships     and who voluntarily seek help.      Violence in intimate partnerships constitutes a serious problem worldwide and there is reason     to believe that cognitive behavior therapy has some effect on the reduction of violent     behavior. However, there are currently too few randomized controlled studies to conclude     about the effectiveness of cognitive behavior therapy for this client group.   "
124670|NCT01653847|"     The immune system is the body's defense against infection and other disease. After     transplantation, the body sees the new organ as foreign and tries to destroy or reject     it. Immunosuppressive medications help to prevent the immune system from attacking a     transplanted organ. The primary purpose of this study is to investigate the impact of two     maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly     selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil     (group 2) as their immunosuppression medication.      This study will enroll adult patients who are scheduled to receive a kidney transplant.      The study is designed to understand the mechanisms of Everolimus in regards to kidney     function in transplant recipients. The investigators hypothesis is that decreased exposure to     Tacrolimus to the immune system will then translate in better renal allograft function.   "
124674|NCT01653795|"     The aim of this randomized prospective study is to compare two single-use laryngeal mask     airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators     hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA     Unique.   "
124675|NCT01653782|"     This randomized controlled study will evaluate the cost effectiveness of a yoga intervention     compared to two evidence based programs; giving advice to stay active and guided exercise     sessions. The first active program includes a six week standardized strength training program     where the participants are personally instructed by a trained physiotherapist. The second     active program is a six week standardized kundalini yoga program with group sessions twice a     week lead by an experienced yoga instructor. Both programs consist of two exercise sessions     per week and lasts for six weeks. After six weeks the participants are instructed to continue     practicing their program twice a week on their own. The hypothesis are that a kundalini yoga     program as an early intervention for Low Back Pain (LBP) is more cost effective than the two     other interventions studied.      Participants were recruited through the occupational health services and by advertisement in     the local press. Study subjects eligible for inclusion were informed of the study either by     health care personnel at the occupational health care centers or by a research assistant at     the Karolinska Institutet. Subjects were informed that if they were eligible to participate     in the study they would be given the opportunity to participate in one of three approaches     for treatment of neck and back pain.   "
124676|NCT01653769|"     Surgery on the aorta can be associated with significant blood loss. Most commonly this is due     to bleeding at the site of aortic anastomosis. Surgical bleeding is associated with     significant morbidity.      One way to prevent bleeding is to use a special glue (sealant) after performing large     connections on the aorta. The goal of this study is to compare the different methods surgeons     use to stop/prevent bleeding.      The study team will collect medical information about patients before, during, and after     surgery on their aortas, including the methods used to prevent bleeding. This information may     help doctors improve the way that they care for these patients.   "
124677|NCT01653756|"     The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung     function in mild asthmatic subjects following allergen challenge.   "
124678|NCT01653743|"     This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the     efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single     5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin     (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation.     Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective     is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.   "
124709|NCT01653340|"     The purpose of this study is to assess short- and long-term safety, tolerability and efficacy     of cervical High Frequency Spinal Cord Stimulation (HF-SCS) in patients suffering from     chronic migraine refractory to conventional medical therapy.   "
124710|NCT01653327|"     -  The primary objective is to determine the reduction in pain score by ketamine mouthwash          compared to placebo in head and neck cancer patients with refractory mucositis.        -  The secondary objectives are to describe the duration of analgesia and adverse effects          associated with ketamine and placebo.   "
124711|NCT01653314|"     The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg     (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.   "
124712|NCT01653301|"     -  INTERACT study: to evaluate the pathological response rate in cT3 rectal cancer        -  LEADER study: to evaluate the impact on local control of local excision   "
124679|NCT01653730|"     Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen     conserving devices (OCDs) provide greater patient accessibility and mobility during     ambulation and travel. Recent POCs are compact, lightweight, battery-operated, and require no     refill-time, thus meeting patients' clinical and lifestyle needs. There is, however, a lack     of research on the clinical performance of the latest POCs that could help to determine their     ability to maintain patients' oxygen saturations ≥ 90 % during exercise.      Aim: The purpose of this study is to compare the ability of three POCs, with maximum oxygen     production capabilities of 950 to 3000 ml per minute, to maintain oxygen saturations ≥ 90 %     in patients with chronic lung disease during exercise.      Method: Six minute walk tests (6-MWTs) will be administered in order to measure oxygen     saturations by pulse oximetry (SpO2) in up to 20 patients with a diagnosis of either Chronic     Obstructive Pulmonary Disease (COPD), or Pulmonary Fibrosis (PF) with documented exertional     oxygen desaturations of ≤ 85% on room air. All participants will participate in 4 different     6-minute walk tests: the first will be a control walk performed with the participants'     current oxygen system set at their prescribed exertional flow rate. Then, the participants     will perform a walk test with each of the three POCs set at the units' maximum pulse dose     setting. The order in which the participants use the POCs will be randomly assigned using a     sequence generator.      Hypothesis: It is hypothesized that all three POCs will provide oxygen saturations ≥ 90 %     during exercise in patients with chronic lung disease with moderate to severe exertional     oxygen desaturation.   "
124680|NCT01653717|"     The goal of this clinical research study is to find the highest tolerable dose of T cells     that can be given in combination with standard chemotherapy to patients with CLL. The safety     of this combination will also be studied.      The T cells being used in this study are a type of white blood cell that will be taken from     your blood and then genetically changed in a laboratory. The process of changing the DNA (the     genetic material of cells) of the T cells is called a gene transfer. After the gene transfer     is complete, the genetically changed T-cells will be put back into your body. These T cells     may help prevent cancer cells from coming back.   "
124681|NCT01653704|"     The purpose of this study is to compare the effectiveness in learning crisis resource     management (CRM) principles when being an active participant in simulation-based education     versus being an observer participant. The investigators hypothesize that active participants     will improve their CRM skills more than observer participants.   "
124682|NCT01653691|"     Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of     hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy     on children's burned scars has not been measured.   "
124683|NCT01653678|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses. The VITAL Hypertension ancillary study is being conducted among participants     in VITAL and will examine whether vitamin D or omega-3 fatty acids are related to changes in     blood pressure and hypertension.   "
124694|NCT01653535|"     The primary aim of this project is to evaluate the effects of a comprehensive intervention to     prevent severe and chronic conduct problems in a sample of children selected as high-risk     when they first entered school. It is hypothesized that the intervention will have positive     effects on proximal child behavior in middle school, and high school affecting long-term     adolescent outcomes such as conduct disorder, juvenile delinquency, school dropout, substance     use, teen pregnancy, relational competence with peers, romantic partners and parents,     education and employment and social and community integration.   "
124695|NCT01653522|"     The purpose of this study is to determine the effects of triptans and doxycycline on     neuroinflammatory markers in acute migraine.   "
124684|NCT01653665|"     Despite the introduction of multiple preventative measures rates of hospital acquired     infection in the intensive care unit remain high. New approaches to tackling this problem are     required. The neutrophil (a type of white blood cell) is the key cell fighting bacterial and     fungal infection in the body. This research group has already shown that the majority of     patients on intensive care have neutrophils which don't ingest germs effectively and are     therefore less able to fight infection. These patients, whose white blood cells don't work     properly, are much more likely to develop a second infection whilst in hospital (hospital     acquired infection).      Previous work done by this group has shown that by adding a drug called granulocyte     macrophagecolony stimulating      factor (GM-CSF) to a sample of blood from these patients in the lab, it is possible to     restore the ability of the white blood cells to ingest bacteria and fight infection.      This study will test whether it is possible to restore the capacity of patients' white blood     cells to eat germs by giving them GM-CSF as an injection while they are on intensive care.      The study will involve identifying adult patients on intensive care whose white blood cells     don't work properly in this way. Patients taking part in the study will receive an injection,     under the skin, of either the drug, GM-CSF, or a solution which will have no effect     (placebo). The investigators will compare whether those patients who have received the GM-CSF     injection have an improvement in the function of the white blood cells compared to those who     don't.      As well as looking at the function of the white blood cells the investigators will also study     whether there is a difference in the rates of infection picked up in hospital between the two     groups.      This study is funded by the Medical Research Council.   "
124685|NCT01653652|"     The purpose of the current study is to evaluate the efficacy of administering a probiotic in     adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.   "
124686|NCT01653639|"     This is a single dose, open-label, randomized, crossover study in subjects with severe     Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY     14-2222).   "
124687|NCT01653626|"     A matched pair cluster-randomized trial of this intervention package will be conducted in     four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of     the Republic of Guatemala, using the health clinic as the unit of randomization. No external     intervention is planned for control facilities, although enhanced monitoring, surveillance     and data collection will occur throughout the study in all facilities in the four districts.      The package includes 3 interventions: 1) To train health care professionals in emergency     obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ,     multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a     social marketing strategy that promotes institution-based delivery; and 3) To integrate the     role of obstetric nurse and professional midwife in intervention communities to act as     liaisons between traditional birth attendants (TBA) and public health units. A fourth,     cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to     strengthen information systems and monitor perinatal outcomes throughout the two years of the     study.   "
124689|NCT01653600|"     The nitinol stent has proven superior primary patency than balloon angioplasty in superficial     femoral artery lesions. Recent stent design improvements focus on decreasing stent fracture     rates which can negatively impact patency rates by rearranging strut alignment. In the     literature, however, prospective, randomized, controlled, clinical trial for comparison of     stent fracture and primary patency between different nitinol stents has never been performed     except one study; SMART versus Luminexx stent named SuperSL trial. LifeStent is similar to     S.M.A.R.T. stent in the design consisted of the peak-to-valley connected with S-shaped bridge     but is different in lesser bridge (4 bridge vs. 6 bridge), large cell size on stent ends, and     larger cell size than S.M.A.R.T. On the other hand, Recent meta-analysis has shown that the     efficaty of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However,     still specific data regarding a variety of antiplatelet regimen in implanted femoropopliteal     lesion are limited. Upto date, in the literature, never has never been performed the clinical     trial for optimal duration of cilostazol use in the patient undergone stent implantation for     femoropopliteal lesion. Thus, The purpose of our study is to examine and compare Primary     patency and stent fracture between different two-nitinol stents (S.M.A.R.T. CONTROL versus     Lifestent) in femoropopliteal arterial lesion and to examine and compare the optimal duration     of cilostazol use.   "
124690|NCT01653587|"     Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive     strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular     closure device would decrease the prevalence of vascular complications at puncture site,     reaching the non-inferiority criterion when compared to the radial access.   "
124691|NCT01653574|"     The hypothesis of this clinical research study is to discover if the study drug Famitinib     Malate can shrink or slow the growth of pretreated HER2-negative metastatic breast cancer.   "
124692|NCT01653561|"     The hypothesis of this clinical research study is to discover if the study drug apatinib can     shrink or slow the growth of pretreated non-triple-negative metastatic breast cancer.   "
124693|NCT01653548|"     The aim of the present project is to develop and evaluate a novel and brief method of     generalizing habituation (i.e., calming down after being upset) from an original learning     context in the laboratory to other contexts inside and outside the laboratory. Specifically,     the primary aim of this project is to evaluate whether novel habituation reminders (HRs)     introduced following personally-relevant emotional stressors reduce acute negative emotions     and psychological distress outside of an original learning context. Using a team of basic and     applied scientists, over 4 years the investigators expect to screen 420 adult outpatients to     enroll 250 study participants who have extreme difficulties with emotion regulation. These     250 participants will be randomly assigned to one of eight experimental groups, with the     experimental design leading them through 1 or 2 of 3 project experiments.      Actual enrollment: 372 adult outpatients signed consent and enrolled into the study. 222     participants were eligible and began the study. Out of the 222, 210 completed the study (as     opposed to the desired 250).      Experiment 1 will evaluate whether novel auditory HRs following personally-relevant emotional     stressors differentially reduce psychological distress and negative emotions (via self-report     and psychophysiology), compared to no HRs, within the same and different lab contexts after a     1 week delay. Experiment 2 will evaluate whether HRs differentially reduce negative emotions,     psychological distress, difficulties with emotion regulation, and psychiatric symptoms,     compared to sham sounds outside the laboratory across a 1 week period, using 8x daily     assessments of distress and emotions and automated HRs/shams when acute negative emotions are     present. An automated server and cellular phone system will be used to assess distress and     emotional states and to deliver HRs/shams. Experiment 3 will examine the feasibility,     acceptability, and preliminary effect size estimates when participants self-initiate the use     of HRs in their daily lives across a 2 week period when acute negative emotions are present.     The specific randomization rules across the 8 groups are explained in detail in the full     protocol .      Risks in this study may arise from 1) the assessment interviews and questionnaires, and 2)     discussing and hearing self-reported distressing events. Initial analyses will focus on the     success of randomization to groups. The investigators will examine group differences on     possible covariates (e.g., demographic variables) and those that are different across     conditions will be used as covariates. Preliminary analyses will examine distributional     properties of primary outcome measures and correlations among outcome measures and possible     covariates. The investigators will set alpha at .05 for all analyses of primary hypotheses.     To examine the influence of psychiatric symptoms (compared to the HR) on primary outcomes,     the investigators will examine the relationship between baseline clinically relevant     psychiatric variables (e.g., symptom severity) and changes in SUDS, emotional arousal, and     clinical outcomes over time and if appropriate include these variables in primary analyses.     Full data analytic plans are described in the full protocol.   "
124698|NCT01653483|"     This is a randomized, double-blind, placebo-controlled, repeat dose, 2-period, incomplete     block, crossover, safety and pharmacokinetic (PK) study to evaluate 3 once-daily doses of     umeclidinium (GSK573719; UMEC) in adolescent asthma subjects aged 12 through 17 years,) who     are currently using asthma medications that do not contain inhaled corticosteroids (non-ICS).     The objectives are to investigate safety and tolerability, and PK after a 7-day (+2) repeat     once-daily dose of UMEC (15.6, 62.5, and 250 mcg) in asthmatic adolescent subjects. Safety     endpoints will include reported adverse events, vital signs, ECGs, clinical laboratory tests,     and rescue albuterol use. The PK endpoints will include serial PK (plasma and urine)     concentrations and derived parameters.      Twenty four subjects will be randomized to participate in the study for up to 7 weeks     (including: an initial screening visit, a 7 to 14-day run-in, and 2 treatment periods each of     7 (+2) day duration, with a washout period of 7-14 days between treatment periods). There     will be a Follow-up Visit approximately one week after the end of the second treatment     period. Subjects will refrain from using rescue medication for 4 hours prior to any clinic     visits, unless for emergency.      During each treatment period, study medication will be taken once in the morning until the     morning of Day 7 (+2 days) when subjects will return to the clinic for study assessments and     take the last dose of study medication. On Day 7 (+2), subjects will remain in the clinic     overnight for serial assessments (ECG, and PK plasma and urine samples over the 24-hours).   "
124699|NCT01653470|"     The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in     combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus     Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic     solid tumors   "
124713|NCT01653288|"     This study will evaluate the impact of a psychosocial intervention, Coping Coach, delivered     online to children who have experience an acute medical event.      The core study hypotheses are that children receiving the intervention will (1) endorse fewer     maladaptive trauma-related appraisals and (2) demonstrate more adaptive coping (more     support-seeking, more cognitive restructuring, less avoidant coping) at a 6-week follow-up,     and (3) demonstrate lower severity of post traumatic stress (PTS) symptoms and higher health     related quality of life (HRQOL) at 12 week follow-up.   "
124714|NCT01653275|"     The investigators propose a 24 week clinical research trial (12 week observational period     followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone     turnover as the primary outcomes.   "
124715|NCT01653262|"     Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects     with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side     effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis     testing will be performed.   "
124700|NCT01653457|"     Fibromyalgia (FM) is a chronic rheumatic disease of high prevalence and great clinical     impact. However, the treatment for FM has limited efficacy, with an effect size of about 0.5.     Recent studies have found raised levels of glutamate in the insula, hippocampus and posterior     cingulate cortex regions of the brain. This has led a number of authors to suggest the     usefulness of glutamate blocking drugs in the treatment of FM.      Aims: To evaluate the efficacy of memantine in the treatment of pain and other symptoms of FM     and to assess its efficacy in reducing brain glutamate levels in patients with FM. Material     and methods: Randomized controlled trial, of six months duration (including a dose adjustment     period of one month). 60 patients with FM will be recruited for inclusion in the study upon     fulfillment of selection criteria, and they will be randomized in two groups: A) Treatment     group (n=30), will receive 20 mg of memantine o.d ; B) Control group (n=30) will receive     placebo. The main objective is to assess the efficacy of memantine in the treatment of pain     (pain threshold, pain perception) and other symptoms in fibromyalgia (cognitive state, health     status, state of anxiety and depression, quality of life and perceived improvement.     Discussion: There is a need for the development of innovative and more effective alternatives     for the treatment of FM. This clinical trial will determine whether memantine can be     considered as an option in the treatment of FM patients.   "
124701|NCT01653444|"     The purpose of this study is to evaluate the safety and exploratory efficacy of GC1119     (recombinant human α-galactosidase A) for enzyme replacement therapy in Fabry disease     patients.   "
124702|NCT01653431|"     The study will examine whether the effects of computerized brain training are enhanced when     training is combined with mild brain stimulation in patients with mild cognitive impairment.     We hypothesize that this combination will produce greater improvements in cognitive     functioning than computerized brain training alone.   "
124703|NCT01653418|"     BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used     conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell     transplantation. Since these components are all effective in myeloma and bortezomib has shown     promising results in the transplant setting, here the investigators propose a phase II study     to investigate the combination of bortezomib and BEAM as a new conditioning regimen for     patients who relapse or progress after the first autologous transplantation and for whom a     second autologous transplant is considered.   "
124704|NCT01653405|"     Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood     clots (including strokes). Too much anticoagulation increases the risk of serious or even     fatal bleeding, and too little anticoagulation fails to protect the patient against blood     clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the     therapeutic range, the range within which they are protected from clots but not at excessive     risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following     several relatively simple procedures, including following-up promptly when patients are out     of range and focusing on educating and supporting patients with poor control. In this study,     the investigators will promote these practices at the anticoagulation clinics of the New     England VA region, with a goal of improving anticoagulation control.   "
124705|NCT01653392|"     The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine     during pregnancy is independently associated with adverse maternal, pregnancy, or infant     health outcomes.   "
124706|NCT01653379|"     This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with     end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to     identify an appropriate starting dose of DP001 to be used in subsequent studies in this     population and for evaluation of pharmacokinetics of DP001 in ESRD patients.   "
124723|NCT01653158|"     This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and     pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel     in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment     option.   "
124724|NCT01653145|"     The purpose of this trial is to examine the metabolic and behavioral effects of a positive     energy balance induced by adding food to the usual level of activity.      It is hypothesized that: 1) food intake will not differ significantly after 2 days of     positive energy balance induced by a high carbohydrate vs. high fat diet when both diets are     low in energy density, and 2) food intake will be higher after a positive energy balance     induced by a high fat/high energy dense diet vs. a high fat/low energy dense diet.   "
124947|NCT01650233|"     This study assesses the impact of a mindfulness-based stress reduction program compared with     a health education program for urban middle-school male youth on outcomes of psychological     symptoms, coping, stress, sleep, and behavior.   "
124707|NCT01653366|"     This study is a randomized prospective clinical trial of women with metastatic breast cancer.     The purpose of the study is to test if an intervention of regular physical activity review     and physical activity goal setting will allow the subjects to achieve a moderate increase in     physical activity of 6,000 steps per week. The physical activity review will consist of     weekly telephone call to inquire about symptoms and to set physical activity goals. The study     will also look to see if the goal setting intervention will affect the time to progression,     change in BMI, and quality of life. Quality of life will be measured by answers to     questionnaires provided to subjects at regular intervals during the course of the study.     Finally, the study will examine the impact of physical activity on expression of tumor     molecular molecules, insulin levels, and estradiol levels.      Through an intervention of regular physical activity review and goal setting, the     investigators hypothesize that a moderate increase in level of physical activity of 6000     steps per week or more can be obtained by patients with metastatic breast cancer who receive     a goal setting intervention. The investigators propose that those who are able to achieve and     maintain greater than or equal to 22500 steps per week will demonstrate biologic and     molecular differences compared to those who are not able to achieve that level of physical     activity. The investigators expect that people who are more active will have longer to     progression.   "
124708|NCT01653353|"     Residents of nursing homes are endangered by malnutrition and vitamin D deficiency. Our study     checks compliance with Swiss federal recommendations on vitamin D and calcium supplementation     among residents of a Swiss nursing home. A peer physician-applied recommendation on     compliance with the federal recommendations with individual evaluation of the residents will     be sent to the physicians in care. After one year, data will be collected again.   "
124716|NCT01653249|"     This study will consist of 300 women aged 18-50 years. The study will show that a new     therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition     called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause     cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a synthetically     made fragment of HPV protein called E6 and yeast extract called Candin®. Previous studies     have revealed that immune response to E6 is important in fighting HPV. We also know that     injecting Candin has anti-HPV effect since it has been used to treat common warts which are     caused by different types of HPV. The current standard treatment for HSIL is loop electrical     excision procedure (LEEP). The immune system is the part of the body that fights infection     and cancer. This research study will also examine the immune response to the vaccine and its     effectiveness in regressing HSIL. Volunteers would be eligible to enroll in the study if they     have had a recent Papanicolaou (Pap) smear result indicating HSIL or Cannot rule out HSIL,     and if they meet the inclusion/exclusion criteria. Subjects will be eligible to receive     vaccinations if biopsy confirms HSIL. A series of four vaccinations will be given roughly 3     weeks apart, and LEEP will be performed at the end of the study approximately 12 weeks after     the last vaccination.   "
124717|NCT01653236|"     Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype     4 chronic hepatitis C infection will increase the proportion of patients achieving sustained     viral response compared to standard treatment alone.   "
124718|NCT01653223|"     Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It     was also reported that statins could protect endothelial function and cardiac function during     coronary artery bypass graft. We recent found simvastatin reduced myocardial injury during     noncoronary artery cardiac surgery in single medical center. We further investigate that     whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with     cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two     medical centers.   "
124719|NCT01653210|"     This overall research goal will be to develop a mobile-based module to improve glycemic     control during the menstrual cycle in women with Type 1 diabetes mellitus (T1DM). This module     will run on an Android Operating System (OS) and will be available as: (i) a stand-alone     application and (ii) an important additional component to a larger system, the Diabetes     Assistant (DiAs) - a mobile-based medical platform for diabetes applications. This proposal     aims to build one such application or module targeting the improvement of diabetes control in     younger women who experience glucose variation related to their menstrual cycle.   "
124727|NCT01653106|"     The purpose of this study is to compare the effect of short-term (2 hours/120 minutes) and     long-term (6 hours/360 minutes) schedules of crushed ice therapy (cryotherapy). Patients that     receive high dose melphalan for bone marrow transplantation commonly develop significant     mouth pain and sores (oral mucositis) unless cryotherapy is utilized. The goal of this study     is to scientifically determine (using randomization and a larger sample size) if a short-term     schedule is as effective as the standard long-term schedule in preventing, or minimizing the     symptoms involved with oral mucositis. The study is also trying to determine the best dose of     melphalan and how patient's body breaks down melphalan and will obtain blood through central     venous catheter to measure the amount of melphalan in patient's blood at specific times after     the melphalan is infused   "
124728|NCT01653093|"     In standard clinical care, the prostate is imaged by magnetic resonance imaging (MRI) which     is a procedure to take pictures of body structures by using a strong magnetic field and radio     waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher Tesla     number means the magnet has stronger pull. Standard magnetic resonance imaging of the     prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna)     inserted into the body due to the limitations using an external body coil at this magnet     strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla of     creating a signal twice as strong that can be received by the antennas, resulting in better     pictures. The goal of this study is to make the MRI procedure more comfortable for patients     by using an external coil instead of an endorectal coil. With this study, researchers also     want to help patients' health care teams, the surgeons in particular. Researchers will assess     the impact of prostate MRI, without an endorectal coil, done at 3 Tesla and with an external     body coil on helping doctors decide which approaches to disease therapy might be best for     patients as well as correlate patients' study images with all other clinical imaging   "
124729|NCT01653080|"     This study is being done due to a new imaging method that may help others in the future to     improve evaluation of diseases in the eye and eye socket and to help make a decision     concerning best treatment of the disease. Previous studies suggests that dynamic contrast     enhanced MRI is ideally suited to show small structures in the eye and eye socket as well as     to provide information about the eye socket such as blood circulation. This research may also     provide information about the likelihood of the tumor spreading from the eye into other     organs as well as correlate the study images with all other clinical imaging   "
124730|NCT01653067|"     The STORM-trial consists of two parts. In the part I (dose escalation of Temsirolimus) the     primary objective is to establish a maximum tolerated dose of Temsirolimus in combination     with Rituximab and DHAP. Secondary objective is to prove ability to mobilize stem cells in     patients scheduled to high dose therapy.      In the part II (full target dose) the primary objective is to evaluate the ORR in patients     with relapsed diffuse large B cell lymphoma (DLBCL). The secondary objective is to evaluate     progression free survival (PFS), overall survival (OS) and Toxicity.   "
124731|NCT01653054|"     The rationale for this study is that the risk of anal dysplasia in patients with inflammatory     bowel disease as compared to the general population has yet to be investigated prospectively.     There have only been a few articles examining this relationship - preliminary results have     suggested that patients with IBD are at increased risk for abnormal anal pap smears. As high     grade anal dysplasia is strongly associated with an increased risk of anal carcinoma, it is     important to identify all high risk groups that might benefit from routine screening. This     pilot study aims to determine whether patients with IBD in our Bronx population have an     increased risk of abnormal anal Pap smears. We hypothesize that there will be an increased     incidence of abnormal anal pap smears in patients with IBD who have been treated with     immunosuppressants, given that chronic immunosuppression is related to increased HPV     infection.   "
124732|NCT01653041|"     Recipients from living donors kidneys HLA-identical were lower risk for acute rejection,     graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen     for this population.      Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest     incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the     reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated     with chronic use of these agents. Moreover, the use of EVR is associated with increased     incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing     that proteinuria may be the first indication of recurrence of the underlying renal disease,     detailed information about the patient's medical history and histological analysis of the     graft may contribute with additional knowledge in this area.      The aim of this prospective, open, single arm study that will be performed only in the     Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in     recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive     regimen. This will include 100 recipients of first or second kidney transplant from a living     donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a     period of 12 months.   "
124733|NCT01653028|"     This phase II trial studies how well alisertib works in treating patients with sarcoma that     has spread to other places in the body and usually cannot be cured or controlled with     treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
124734|NCT01653015|"     There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit     over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who     are unvaccinated through herd immunity. The goal of this randomized clinical trial is to     determine whether immunizing children in Hutterite colonies with LAIV can provide increased     community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from     Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary     outcome of this study will be laboratory-confirmed influenza as detected by PCR in all     participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include     influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.   "
124735|NCT01653002|"     A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer tissue.     The purpose of this study is to determine whether the assessment of the hypermethylation     level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy makes a     contribution to lung cancer staging.   "
124736|NCT01652989|"     The PILI @ Work project is a 5 year randomized control trial to adapt a weight loss program     for the employees of Native Hawaiian-serving organizations in Hawai'i. The study has two     specific aims:      Specific Aim 1: To adapt and implement a weight loss and weight loss maintenance program in     Native Hawaiian-serving organizations, working with employee representatives to determine how     the intervention can be best implemented with employees at the worksites. Specific Aim 2:     Among employees participating in the program, to test whether weight loss maintenance program     in DVD format is as effective as the weight loss maintenance program in a group face to face     format in maintaining weight loss for employees who complete weight loss program.      The investigators hypothesize that the PILI @ Work interventions can be effectively adapted     and implemented in a worksite settings with active participation by employees and employers.     The investigators also hypothesize that overweight (BMI ≥ 25) and obese (BMI ≥ 30) employees     who complete weight loss portion of the intervention, and are randomized to received the     weight loss maintenance intervention via DVD will have similar success at maintaining weight     loss compared to those randomized to PILI Maintenance in group meetings or settings. The     investigators hypothesize that will will also be true for physical functioning,blood     pressure, daily self-weighing, low to moderate fat and low calorie diets, and daily physical     activity.   "
124737|NCT01652976|"     The purpose of this research study is to determine if the study drug, dasatinib, given in     combination with 5-Fluorouracil, leucovorin and oxaliplatin (FOLFOX) will work against     metastatic pancreatic cancer.      Dasatinib is a Food and Drug Administration (FDA) approved drug for treating chronic     myelogenous leukemia and acute lymphoblastic leukemia, however it is not currently approved     for use in the treatment of pancreatic cancer.   "
124738|NCT01652963|"     The proposed research aims to investigate whether people with intellectual disabilities are     able to understand and apply the theoretical principles of cognitive behaviour therapy (CBT)     regarding the interaction between events, beliefs and emotions. Two studies are designed to     assess and train the ability to link events, beliefs and emotions.      Study 1 pilots computer-based tasks to assess the ability to link events, beliefs and     emotions as well as a computer-based training programme aimed to link events and emotions.     Task and training stimuli will be presented by line drawings to investigate whether a     picture-based approach can reduce the impact of verbal ability on task performance. Training     effectiveness is evaluated compared to a no-training control task.      Study 2 compares the line drawings-based approach of Study 1 to a photographic approach to     investigate whether the use of photographs can increase training effectiveness and further     reduce the impact of verbal ability. It is hypothesised that the high reality value of     photographic task stimuli, as compared to line drawings, will have positive effects on the     assessment and training of CBT skills. It is anticipated that the findings of this research     will improve our ability to help people with intellectual disabilities receive CBT.   "
124739|NCT01652950|"     Background: Physical inactivity and increased sedentary activity are major lifestyle factors     that contribute to increasing burden of disease globally. There is evidence that the rise in     prevalence of non-communicable diseases (NCDs) was largely responsible for growth in private     insurance spending between 1987 and 2002 in the USA. There is renewed interest by health     plans to implement incentivized health promotion programs, in an effort to change health     behavior and thereby reduce health care costs related to NCDs. However, the literature on the     role of incentives and rewards in influencing physical activity behavior, specifically, is     relatively sparse, and the field of behavioral economics applied to health behavior is     relatively new.      Most studies that have been conducted typically report findings with limited, well-defined     incentives that are offered for a short period. These studies generally have shown a     moderation in health care costs compared to non-participants. In a cross-sectional study of     approximately 940,000 members of a national private health insurance, Discovery Health, the     investigators have previously demonstrated a significant and inverse relationship between     levels of participation in fitness-related activities and medical claims associated with     hospital admissions. More recently, in a retrospective, longitudinal analysis over 5 yrs,     amongst more than 300,000 members, the investigators found that participation in     fitness-related activities increased over a 5-yr period and was associated with a     significantly lower probability of hospital admissions and inpatient claims costs.      Aim: The current study primarily aims to prospectively compare the effectiveness of diverse     incentives on physical activity behavior, monthly over a 12 month period following     registration, in a cohort of newly-enrolled, adult members of the Vitality health promotion     program.      Study sample and random allocation to groups: Newly enrolled adult members of the Discovery     Health medical plan and who have, themselves, prospectively registered for the Vitality     health promotion program, will be eligible for the study, and will be invited to participate     by Discovery Health. This recruitment, enrollment and random allocation to groups will be     initiated via a web-based email communication, from Discovery Health, over a period of 5     months. A final sample of 9000 adult members will be randomly allocated by Discovery Vitality     (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed     each month for a period of 12 months.      The intervention arms include a Control group, in which members will be offered no additional     incentives, other than the existing incentives, to engage in all points-earning physical     activity. There will also be a Communication Group, in which members will be offered the base     program and, in addition, will be sent bi-weekly communications by alternating email and text     messaging which included information on the importance of physical activity, tips on     accumulating fitness points on the base program, a status update of points earned and     information on benefits and rewards offered.      The incentive arms are comprised of a Direct Payment Group, a Charity Incentive Group, a     Lottery Pay-out Group, and a Choice Group. In each case, members will be offered the base     program and supplementary communication described above. In addition, individuals will be     offered the equivalent of one of four possible incentive amounts depending on the level of     participation in fitness-related activities. Enrollment will be over a period of 5 months,     and the intervention will take place over a period of 12 months, following registration, with     a monthly pay-out for the incentive arms of the trial.      The following outcomes of interest will be measured:        -  Number of new participants (registration) in the fitness programs of Vitality        -  Points earned, as a proxy for levels of participation, for engaging in physical activity          (gym visits)        -  Self-reported measures of physical activity levels, smoking and healthy eating behaviors        -  Health care claims (de-personalized) for the 12 month period following the 12 months          intervention        -  Survey of attitudes to incentives and rewards in the post-study questionnaire      Ethical considerations: Ethics approval has been obtained from the University of Cape Town/     University of Pennsylvania Research Ethics committees. Consent will be obtained from each     subject, who agree to participate or 'opt out' and agree that their medical claims and     utilization data may be examined in a de-personalised manner according to their group, and     level of participation. Further, should a member choose to drop out in the course of the     study, or refuse to participate, there will be no adverse impact on their medical plan     coverage and they are free to withdraw without prejudice at any time during the course of the     study.   "
124740|NCT01652937|"     Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with     Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying     Antirheumatic Drugs (DMARDs).   "
124741|NCT01652924|"     The purpose of this study is to determine whether mechanical ventilation with facial mask     during induction anesthesia in the population of 1month to 14years is associated with less     risk of gastric insufflations as compared with manual ventilation.   "
124757|NCT01652703|"     The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every     2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in     low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in     Japanese adults with hypercholesterolemia and high cardiovascular risk.   "
124742|NCT01652911|"     This is an open-label, single arm, non-randomized safety and efficacy study, where     participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the     subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into     the Cell Pouch™.      The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in     adult participants with Type-1 diabetes receiving islet transplantation for the first time.      Secondary objectives are the following:        1. To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted          with islets into the Cell Pouch™ who achieve and maintain insulin independence after          islet transplantation.        2. To obtain preliminary data on the efficacy of the Cell Pouch™ to maintain adequate          immunological protection against both allo- and autoimmunity of islet transplant          recipients.        3. To determine through retrospective analysis comparative metabolic function and          engraftment efficiency using patients undergoing standard intraportal islet          transplantation under the current alemtuzumab standard of care protocol.   "
124743|NCT01652898|"     The study consists of a Pilot Phase (to assess safety and the local tolerability of highest     AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety and     tolerability of AOP LDLA202, ONO LDL50 and esmolol bolus administrations by measurement of     blood concentrations of landiolol, esmolol and their metabolites, and by monitoring ECG,     blood pressure and adverse events).   "
124744|NCT01652885|"     The purpose of this study is to investigate the safety, tolerability, and systemic exposure     of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.   "
124745|NCT01652872|"     A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with     chronic kidney disease and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies     to evaluate the proportion of subjects receiving at least one red blood cell transfusion. In     the Hb-based titration group, darbepoetin alfa doses will be titrated to maintain hemoglobin     (Hb) ≥ 10.0 g/dL. In the fixed dose group, subjects will receive a fixed dose of darbepoetin     alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will     be blinded. Subjects will be followed for approximately 2 years from the date of     randomization.   "
124746|NCT01652859|"     The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different     liposomal amphotericin B injections after single IV infusion at the same dose in normal     healthy subjects.   "
124747|NCT01652833|"     To ensure the appropriate administration of Vectibix for the treatment of mCRC with wild-type     KRAS in real-world practice, it is important to understand the awareness of practicing     oncologists regarding the correct indication and appropriate administration of Vectibix. It     is also critical to monitor changes in oncologists' awareness and practice between the     different rounds of the study.   "
125438|NCT01643200|"     Evaluate the safety and feasibility of the Medtronic Zotarolimus stent to improve erectile     function in males with sub-optimal response to PDE5i therapy due to atherosclerotic lesions     of the internal iliac and/or internal pudendal arteries.   "
124748|NCT01652820|"     Randomized study in 2 arms, without any masking in patients with non small cell lung cancer,     histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA,     according to the TNM classification of the American Joint Committee for cancer. In one arm     will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed     by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by     concurrent radiotherapy with carboplatin-docetaxel   "
124749|NCT01652807|"     This study looks at an 8-week hatha yoga intervention for women reporting high levels of     stress, a risk factor for various forms of psychopathology.   "
124750|NCT01652794|"     The purpose of this phase I study is to determine the highest dose of carboplatin and     gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic     cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called     the maximum tolerated dose (MTD). To determine the MTD, patients will receive different     amounts of carboplatin and gemcitabine.   "
124751|NCT01652781|"     Approved dosing schedule of azacitidine for myelodysplastic syndrome (MDS) is 75 mg/m^2/day     subcutaneous for 7 consecutive days every 28 days, which is based on the data from standard     chemotherapy regimen and a Phase I safety clinical trial. Since the optimal dosage of this     drug has not been found yet, it remains as a subject of clinical study that needs to be     examined. If initial toxicity is minimized by developing dosage/regimen that replaces the     standard therapy, it will be possible to provide continuous treatment with increased     convenience by patients and treating physicians as well as improvement for safety in elderly     patients or those with serious cytopenia. In addition, it is expected to lead to a better     response by strictly keeping a treatment schedule.      Recent US study showed that 5-day regimen showed similar treatment results, but retrospective     data from Spain showed lower response rate in 5-day regimen. Considering the recent     circumstances around dosage and schedule of azacitidine in lower risk MDS, a Phase II     clinical trial is planned in lower risk MDS patients in order to explore the efficacy in     5-day treatment by comparing prospectively with 7-day standard regimen.   "
124752|NCT01652768|"     The purpose of this pilot study is to investigate the feasibility of an early palliative care     intervention (PRESENCE: Providing Resources Education, Support, and Enabling New brain tumor     patients to Cope Effectively) and the effect of the intervention on patient and caregiver     distress.   "
124753|NCT01652755|"     To evaluate the utility of plasma cystatin C(pCysC) as a predictive and diagnostic marker of     acute kidney injury(AKI) in patients undergone cardiopulmonary bypass surgery.   "
124754|NCT01652742|"     To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single     dose administration.   "
124755|NCT01652729|"     To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once     weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in     subjects with type 2 diabetes mellitus.   "
124756|NCT01652716|"     To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once     weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with     type 2 diabetes mellitus.      To examine the long-term (52 weeks of treatment) safety and effect on glucose control of     exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.   "
124758|NCT01652690|"     The objective of this prospective, observational study in Czech Republic and Slovakia is to     describe per country the characteristics of women treated with denosumab in routine clinical     practice and the clinical management of these patients during the first 2 years of treatment.     In addition, the study aims to collect safety data in the real-life clinical practice     settings on adverse drug reactions (ADRs) and serious ADRs.   "
124759|NCT01652677|"     The aim of research to study therapeutic possibilities of navigation transcranial magnetic     stimulation in stroke rehabilitation, finding optimal protocol.   "
124760|NCT01652664|"     The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of     Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution     (0.5% or 0.25%) in pediatric glaucoma patients.   "
124761|NCT01652651|"     The purpose of this study is to report preliminary outcomes of executive function and     psychopathology symptoms of a manual-based psychological intervention for adolescents     diagnosed with learning disorders- I can succeed (ICS).   "
124762|NCT01652638|"     The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic     profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by     Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP     Pharmaceuticals, through the determination of activity of the following markers:        -  Anti-FXa;        -  Anti-FIIA.   "
124763|NCT01652625|"     Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative     treatment available to date. The challenge remains in patients that do develop drug     resistance and/or secondary infection, although topical corticosteroids and antimicrobials     are the first therapeutic choice. The aim of the study was to evaluate the efficacy and     safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative     therapy for minor RAS.      Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule     form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic     function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally     applied on RAS among Chinese population.      In this study, a randomized, double-blind, placebo-controlled clinical trial (from March 2010     to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing     Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days.     An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day 3 and Day 5.     Any noted adverse reactions were recorded.   "
125129|NCT01647815|"     The main objective of this study is the demonstration of an increase of over 50% of the     surface visible on ultrasound (mm2) of the axillary vein and subclavian vein in arm abduction     (90 °) and external rotation (90 °) with respect to the surface of the subclavian vein along     the arm body.   "
124766|NCT01652586|"     Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and     analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are     associated with respiratory depression and hypotension. The aim of this study was to compare     the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect     without serious respiratory depression, with conventional midazolam/remifentanil combination     on sedative and analgesic levels in patients undergoing endocardial ablation.   "
124767|NCT01652573|"     X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United     States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone     call FGF23, which makes the body waste phosphate. This study is designed to determine if     nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and     reduce phosphate wasting in patients with XLH. In this study the investigators will:        1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels          of FGF23 in patients with XLH.        2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH.        3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D          and calcium absorption from the intestine.        4. Make sure that nasal calcitonin is safe and well tolerated.   "
124768|NCT01652560|"     - The purpose of this study is to evaluate the efficacy and safety of the application of     bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.   "
124769|NCT01652547|"     This study will evaluate the preliminary safety, pharmacokinetics, and anti-tumor activity of     pasireotide s.c. in patients with metastatic melanoma or metastatic Merkel cell carcinoma.     The study consists of three phases: screening, intra-patient dose-escalation, and follow-up     phases.      In the screening phase patient will be informed of all aspects of the study and sign informed     consent forms and then be screened for study eligibility.      During the intra-patient dose escalation phase, 18 patients will be treated with pasireotide     s.c. 300 μg t.i.d. for 2 weeks. If there are no unacceptable AEs, defined as drug-related     clinically meaningful, uncontrolled grade 3 or any grade 4 toxicities, patients will be dose     escalated to 600 μg t.i.d. for 2 more weeks, then 900 μg t.i.d. for 2 weeks and then 1200 μg     for 2 weeks provided that there are no unacceptable AEs. Each patient will be in the dose     escalation phase for a maximum of 8 weeks.      At end of the intra-patient dose escalation phase, patients will be allowed to switch to 80     mg pasireotide LAR i.m. q 28 d (or a lower dose in case of toxicity) for an additional 6     months or until disease progression, or unacceptable AEs, or patient withdraws consent. In     addition, all patients will keep their pasireotide s.c. t.i.d. treatment (same dose as that     at the end of the 8-week dose escalation phase) during the first 2 weeks of the LAR follow-up     phase, except on the day receiving the first LAR dose because of an anticipated initial burst     of drug release.   "
124770|NCT01652534|"     The purpose of this study is to explore the efficacy of the drug Amantadine for the treatment     of freezing of gait in patients with Parkinson's Disease. The investigators hypothesize that     amantadine is useful for management of freezing of gait in subjects with Parkinson's Disease.   "
124771|NCT01652521|"     The effects of pleural drainage on lung mechanics are unknown. Insertion of esophageal     balloon will allow us to measure and assess pleural pressure, and thus assess any possible     effects of pleural fluid drainage may have on lung mechanics.   "
124772|NCT01652508|"     The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance     and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary     healthcare settings.   "
124773|NCT01652495|"     The purpose of this study is to compare the efficacy and effects on the     hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types     of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder     tendinopathy.   "
124774|NCT01652482|"     This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy     of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU],     and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with     Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after     first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be     randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated     time on study treatment is until disease progression or unacceptable toxicity occurs.   "
124775|NCT01652469|"     Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are     assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then     randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel).      It is hypothesized that the VeriStrat test results are able to predict the benefit of     treatment with erlotinib vs docetaxel. This would suggest a significant improvement in     progression-free survival for VSG patients when treated with Erlotinib, and no significant     improvement in VSP patients who receive the same treatment.   "
124776|NCT01652456|"     This is a multicenter, interventional, randomized study for preventive and therapeutic     strategies for patients with head and neck or Lung cancer; contribution of an addiction     support   "
124777|NCT01652443|"     The current study will explore relationships and health in the OEF/OIF Veteran population.     Specifically, this study will examine PTSD symptom severity, traumatic brain injury,     relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and     belongingness, and suicidal ideation.   "
124778|NCT01652430|"     This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat     think and react to certain information, and whether or not this has an influence on suicidal     thoughts.   "
124779|NCT01652417|"     Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown.     Despite this treatment, most patients will have chronic kidney disease. From our previous     studies, the investigators believe that high dose steroids by methylprednisolone bolus will     improve patient outcome and renal function.   "
124780|NCT01652404|"     The purpose of this study is to give conclusive evidence on whether serial PCT     (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic     treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).   "
138765|NCT01468402|"     The purpose of this study is to determine predictive factors in the pelvic magnetic resonance     in the response of arterial embolization of uterine leiomyoma.   "
124781|NCT01652391|"     Insufficient cognitive control over emotional distracters is characteristic for major     depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is     associated with this deficit. In this study the investigators assess the effect of an     enhancement of dlPFC activity in MDD patients by anodal transcranial direct current     stimulation (tDCS) on cognitive control.      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators     determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD     patients and healthy controls. To assess the cognitive control the investigators use a     delayed response working memory (DWM) task with pictures of varying valence presented during     the delay period.   "
124782|NCT01652378|"     In the proposed study, the investigators will assess the brain response to medication probes     the investigators have previously studied with SPECT. The brain response to ondansetron and     lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI     (fcMRI).   "
124783|NCT01652365|"     The purpose of this study is to assess the feasibility and impact of introducing subsidized     malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda. This is a     randomized controlled trial at the village level, taking place in 6 districts in Eastern     Uganda. Licensed drug shops in selected villages were trained in proper RDT storage,     administration, interpretation and disposal and were given access to subsidized RDTs for     sale. This study explores whether drug shop owners--when given access to training and     subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what volume     and what price. The investigators also explore whether shops will safely store, administer,     interpret and dispose of RDTs and to what extent they will use RDT results to guide treatment     recommendations. Finally, the study explores whether making RDTs available for sale in local     drug shops has a community level impact on diagnostic testing and appropriate treatment for     malaria.   "
124784|NCT01652352|"     Researchers from the University of South Florida's Rehabilitation Engineering program are     looking for volunteers to participate in a research study for experimental evaluation of     wheelchair-mounted robotic arms (WMRAs).      Participants will operate commercially available and developmental WMRAs in a physical test     environment. The study will serve to identify desirable design features of WMRAs and input     devices so that future production systems may further increase the quality of life of     potential users.      The study will also promote both the justification of prescribing WMRAs to enhance quality of     life through the proposed standard testing method, and awareness for the emerging assistive     robotics industry.   "
124785|NCT01652339|"     To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male     subjects        -  PK parameter evaluation        -  Safety profile evaluation   "
124786|NCT01652326|"     The overarching goal of this project is to improve the clinical quality of patients with     Benzodiazepine-resistant alcohol withdrawal syndrome.   "
124787|NCT01652313|"     The purpose of this study is to fulfil regulatory requirements for registration of a new     chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease     (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the     efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase     III studies.   "
124865|NCT01651299|"     The primary objective of the study is to evaluate the responsiveness and utility of several     clinical outcome assessments in the setting of copperhead snakebite. The secondary objective     is to characterize the clinical course of signs, symptoms and impairment during the recovery     phase of copperhead snakebite.   "
124788|NCT01652300|"     Periodontal diseased during pregnancy are associated with many unpleasant prenatal     consequences including preeclampsia, preterm labor, and low birth weight (LBW). Treatment of     such diseases and observance of oral and dental hygiene may to some large extent prevent such     consequences. Unfortunately previous studies have shown that pregnant women have very little     knowledge of oral and dental health implications. Given the fact that pregnancy my be a     unique opportunity to initiate correct hygienic behaviors in young women, this paper has     focused on studying the effects of oral and dental health education during pregnancy.      In this single blind clinical trial study,140 pregnant women receiving care from Khaje Rabi     Regional Health Center in Mashhad city who were members of a community based multi-center     were chosen by systematic clustering methods and randomly allocated into test and control     groups. After intervention, two questionnaires were completed for demographic and pregnancy     details of the participants. Knowledge, health belief and health behavior were assessed     before intervention. The test group had two educational sessions lasting 1 hour, focused on     oral and dental health and especially on oral and dental health during pregnancy. women in     the control group received no education. Knowledge, health belief and health behavior were     assessed immediately after and one month after intervention of all participants. Analysis of     data was done using SPSS, t-test and chi-square tests.   "
124789|NCT01652287|"     The investigators believe a readily available drink containing a high dose of probiotics has     the potential to improve compliance through many of these mechanisms. This product also has     the potential to positively impact the health of children and adults around the world, as     yogurt will likely be more appealing to both children and their parents for long term     consumption than pharmaceutical-like preparations. In addition to the benefits associated     with the consumption of probiotics, there is an increased health benefit from consuming     yogurt, a nutrient dense food.      More specifically, the rationale for this Phase I study is to determine safety of this yogurt     drink and comply with FDA recommendations pertaining to an Investigational New Drug     application. The investigators hypothesize that BB-12 is safe in generally healthy children     ages 1-5 years.   "
124790|NCT01652274|"     It is well known that traffic accidents are one of the major reasons for death in childhood.     Unfortunately scientific and statistical data usually comes from developed countries. In this     study, the investigators will try to evaluate Turkish families' knowledge on Child Passenger     Safety, observe how they carry their babies in the car and investigated the reasons behind     the undesired behaviors.   "
124791|NCT01652261|"     The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and     dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with     treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine,     procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG)     positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has     non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is     to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.   "
124792|NCT01652248|"     Patients with pacemakers often have undiagnosed heart muscle weakness. When a pacemaker     battery has run down, it is easily replaced by a short procedure. In those with heart muscle     weakness, who use their pacemaker most of the time (rather than acting just as a back-up) the     investigators want to find out if adding a further lead to their pacemaker system improves     their heart's function, kidney function and exercise capacity.   "
124793|NCT01652235|"     The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a     clinical trial approved by US FDA to study the safety and effectiveness of the Zenith®     p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic     aneurysms.   "
124794|NCT01652222|"     The purpose of the study is to assess the efficacy of the systematic application of the     CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's     disease or other advanced stage dementia.   "
124795|NCT01652209|"     Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who are     the primary targets of the drug, long term efficacy in the improvement of the left ventricle     ejection fraction upon the first cell treatment is to be evaluated and compared with the     current existing treatments (contemporary drug treatment).This study will also compare the     efficacy and safety of single dose of hearticellgram-AMI to a two dose regimen of     hearticellgram-AMI.   "
124796|NCT01652196|"     This phase II trial studies how well giving aflibercept together with combination     chemotherapy works in treating patients with previously untreated colon or rectal cancer that     is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the     growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells   "
124797|NCT01652183|"     The insertion of an urinary catheter in a patient undergoing a surgical procedure, especially     in urinary interventions, may lead to catheter-related bladder discomfort with varying     degrees of severity during the postoperative period. Catheter-related bladder discomfort     (CRBD) symptoms associated with indwelling urinary catheter are similar to overactive bladder     symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning     sensation with or without urge incontinence. Paracetamol is a drug with proven efficiency for     the management of mild and moderate postoperative pain. In this study, the investigators     hypothesized to address the effect of single-dose intravenous paracetamol on postoperative     CRBD following percutaneous nephrolithotomy surgery (PNL).   "
124835|NCT01651689|"     Hair disorders, expecialy scarring alopecia were diagnosed by scalp biopsy specimens in     horizontal and vertical sections.(1-4) Data on hair density in Thais are lacking, although in     Asians have more fewer hairs than whites.(5-7)Howevery, previous study from East Asian just     had only one study and the data was more differently from West Asian and whites. Then this     study was performed to evaluate hair density in Thais, and compared to previous study.   "
124956|NCT01650116|"     The purpose of this study is to verify any existing relationship between urinary parameters     (such as excretion of sodium, chlorine, urinary partial CO2 pressure [PuCO2]) and general     volemic indicators (such as PiCCO, ScvO2, O2 delivery) during liver transplant.   "
124798|NCT01652170|"     This study will consist of a brief interaction with the subject or parent or guardian to     obtain consent, collect a blood sample, medical history, and physical examination of those     who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well     as processed into plasma in order to compute the APPY1 Test result, which is based on a     combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the     APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for     those subjects that were discharged from the ED without an appendectomy or diagnosis of acute     appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly     reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing     radiation in children, adolescents, and young adults.   "
124800|NCT01652144|"     The purpose of this study is to find out what effects a new drug AT7519M has on mantle cell     lymphoma.   "
124801|NCT01652131|"     There is no objective evidence of how long intravenous solutions remain inside venous blood     vessels after they have been administered, therefore there is no definite guideline of how to     administer them in the preoperative setting. Besides, obese patients represent a particular     group of subjects as they theoretically with-hold a constant inflammatory response and that     would modify the way solutions behave intravenously, that is how long they remain inside.      Having said this, we wish to describe the way colloid solutions behave in this group of     patients by taking serial blood samples in 12 obese patients after a colloid infusion, to     calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it     remains intravascularly.      All this in the hope this information will help, in the near future, to establish a more     objective way to use these solutions and avoid possible complications due to     over-administration.   "
124802|NCT01652118|"     The purpose of this study is to determine of clarithromycin effect on developing of     bronchopulmonary dysplasia in preterm babies.   "
124803|NCT01652105|"     Randomized clinical trial of two preoperative diets before bariatric surgery (gastric     bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected     for a gastric bypass procedure   "
124804|NCT01652092|"     This is a standard of care treatment guideline for allogeneic hematopoetic stem cell     transplant (HSCT) in patients with primary immune deficiencies.   "
124815|NCT01651949|"     This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV     vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV     efficacy findings in young women to young men based on the demonstration of similar     immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody     responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody     responses in young women.   "
124816|NCT01651936|"     The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate     (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or     intolerance to anti-tumor necrosis factor α (anti-TNF-α) therapy. The primary hypothesis of     this study is that among participants with active RA, MK-8457 100 mg twice daily (BID) + MTX     will be superior to placebo + MTX as measured by the change in Disease Activity Score 28     C-Reactive Protein (DAS28-CRP) after 12 weeks of treatment.   "
124805|NCT01652079|"     This research study is a Phase II clinical trial. In addition to studying safety, Phase II     clinical trials test if the investigational drug is effective and whether the drug works in     treating a specific cancer. Investigational means that the drug is still being studied and     that research doctors are trying to find out more about it-such as the safest dose to use,     the side effects it may cause, and if the drug is effective for treating different types of     cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet     approved CRLX101 for your type of cancer.      Camptothecin is a chemical extracted from plants that is the basis for the standard     FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering     with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of     camptothecin and a large molecule (nanoparticle)that appears to allow more of the     camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the     tumor may increase the probability that the tumor cells will be damaged.      CRLX101 has been well tolerated in the laboratory and in participants with different kinds of     cancer.      Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer.     Bevacizumab has been successfully combined with many chemotherapy partners.      It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique     clinical activity in combination in the treatment of this disease due to the simultaneous     inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically, it     is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential to     interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that this     combination will work to treat your type of cancer.   "
124806|NCT01652066|"     the aim of the study is to get evidence for an enhancement of immune status in subjects after     probiotics mixture consumption ( lactobacillus gasseri PA 16/8, Bifidobacterrium longum SP     07/3, Bifidobacterium bifidum MF 20/5) based on influenza vaccination model - compared to     placebo.   "
124807|NCT01652053|"     The primary endpoints of the investigation will include assessment of the maintenance of disc     height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of     pain as measured by Visual Analog Scale (VAS) at six months post-surgery. It is anticipated     that outcomes with the InterCushion Disc Nucleus Prosthesis (DNP) will be comparable to or     better than the historical published results for discectomy alone.   "
124808|NCT01652040|"     The goal of this proposal is to investigate the efficacy of a complimentary approach of     evoked resistance training and testosterone replacement therapy on the changes in body     composition and metabolic profile after SCI. The proposed method could become a recommended     and simple intervention especially for individuals with limited access and poor tolerance to     exercise. The rationale is based on the evidence that individuals with SCI experience decline     in anabolic hormones which may be responsible for the deterioration in body composition and     metabolic profiles and leads to increase obesity, type 2 diabetes mellitus, dyslipidemia and     subsequently cardiovascular disease. The designed study will provide explanation to the     adaptations in the energy source of the muscle cells in response to training.   "
124836|NCT01651676|"     The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of     life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary     disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days)     during the implementation of a LABD (Long-acting bronchodilator) treatment.      The main objective is to compare the total Score of the VQ11 auto-questionnaire before and     after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality     of life linked to health, specifically in the COPD.   "
124837|NCT01651663|"     The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the     treatment and Prophylaxis of Influenza and Common Cold   "
124809|NCT01652027|"     Hemophilia A is a congenital bleeding disorder caused by deficiency of factor VIII (FVIII)     and is treated by replacement therapy with FVIII concentrate. Approximately 30% of people     with severe hemophilia A develop neutralizing antibodies, called FVIII inhibitors, which     interfere with the function of FVIII concentrates. The reason that some, but not all, people     with severe hemophilia A develop inhibitors is incompletely understood. Understanding     individual and environmental risk factors is important to be able to prevent and possibly     treat inhibitors. This study will look at individual and treatment characteristics in babies     with severe hemophilia A who have not yet received treatment with FVIII (called Previously     Untreated Patients, or PUPS). Subjects in the study will be asked to provide diaries of     treatments, medications, and illnesses. Treatment will be directed by the subjects'     physician, but all subjects will receive Advate, a third-generation recombinant FVIII     product. Subjects will have blood drawn for laboratory tests, which include studies of the     immune system and genetic studies of the FVIII mutation, before and 7-9 days after the first     treatment with FVIII, and 5 days (+/-2 days) after the 5th, 10th, 20th, 30th, 40th, and 50th     days of treatment with FVIII (exposure days). The duration of the study will be first 50     treatments or 3 years, whichever comes first.   "
124810|NCT01652014|"     This study will determine the safety and applicability of experimental forms of umbilical     cord blood (UCB) transplantation for patients with high risk hematologic malignancies who     might benefit from a hematopoietic stem cell transplant (HSCT) but who do not have a standard     donor option (no available HLA-matched related donor (MRD), HLA-matched unrelated donor     (MUD)), or single UCB unit with adequate cell number and HLA-match).   "
124811|NCT01652001|"     The aim of our study was to evaluate the clinical efficacy of a topical sialogogue spray     containing 1% malic acid on patients affected by xerostomia caused by drugs.      This research took the form of a double-blind, randomized clinical trial at Faculty of     Dentistry of University of Granada (Spain). Participants with antidepressant-induced and     antihypertensive-induce xerostomia were divided into two groups: for the first 'intervention     group' a topical sialogogue spray (1% malic acid) was applied, while for the second 'control     group', a placebo spray was applied; for both groups the sprays were applied on demand during     two weeks. The Dry Mouth Questionnaire (DMQ) was used to evaluate xerostomia levels before     and after product/placebo application. Unstimulated and stimulated salivary flows rates,     before and after application, were measured.   "
124812|NCT01651988|"     OBJECTIVE: To determine the efficacy of ketamine-propofol anesthesia in a mixture 1:2 (1 mg     of ketamine per 2 mg of propofol) for short minimally invasive surgical procedures.      METHODS: The investigators performed a prospective study through randomization of 77 patients     undergoing short surgical procedures in two study groups: one received a mixture of     ketamine-propofol in a 1:1 ratio, and the other received a 1:2 mixture. Data were stored in     an Excel spreadsheet and analyzed using the statistical program Epi-Info (TM) 3.5.3. The     investigators performed the comparison of qualitative and quantitative variables.      KEY WORDS: ketamine, propofol, anesthesia.   "
124813|NCT01651975|"     Dysphagia is extremely common. The importance of providing adequate nutritional support to     persons with dysphagia is the cornerstone to exceptional care. Diet modification with     thickening agents is an essential aspect of this nutritional support. The purpose of this     investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based     thickening agent (Thickenup Advance or TUA).   "
124814|NCT01651962|"     Labor pain is a major factor in making the placement of an epidural catheter difficult. The     epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve     this goal as fast and safely as possible it would be helpful to have a parturient who can     tolerate and co-operate with the placement of the epidural catheter.      Briefly stopping contractions, the cause of labor pain, could be the key to achieve this     goal.      This study will evaluate the safety, efficacy and duration of the drug terbutaline for this     purpose.   "
124817|NCT01651923|"     The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic     profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by     Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP     Pharmaceuticals, through the determination of activity of the following markers:        -  Anti-FXa;        -  Anti-FIIA.   "
124818|NCT01651910|"     The aim of the following study is to identify if cancer patients in pain report unmet     supportive care needs that are comparable to the general cancer population or if these unmet     needs are exacerbated depending on whether their pain is controlled, uncontrolled or if the     patients have intermittent breakthrough pain. 312 cancer patients, who have reported to have     either controlled, uncontrolled or breakthrough pain, will complete a series of     questionnaires at two time points. The primary outcome is to determine the prevalence of     self-perceived unmet supportive care needs, as identified by the Supportive Care Needs Survey     -Short Form (SCNS-SF), in people who have pain caused by their cancer or cancer treatment.      Hypothesis- Patients with pain caused by their cancer or cancer treatments will report unmet     needs, which will increase if their pain is uncontrolled or if they have breakthrough pain.      Secondary Objectives-        1. To establish if other confounding factors -such as age, gender, marital status,          diagnosis, educational level and treatment, are significant predictors in the reporting          of unmet needs of people with cancer or cancer treatment related pain.        2. To establish if there are any other symptoms, identified by the Memorial Symptom          Assessment Scale - Short Form (MSAS-SF), that are significant predictors in the          reporting of unmet needs of people with cancer or cancer treatment related pain.        3. To compare the prevalence and severity of self-perceived unmet supportive care needs          between people who experience controlled pain, uncontrolled pain and breakthrough pain.        4. To compare the prevalence and severity of unmet supportive care needs of people whose          pain has become controlled or uncontrolled over a period of four weeks.        5. To identify if there are any changes in the participants' symptoms, Eastern Cooperative          Oncology Group (ECOG) performance score or treatment that could contribute to a change          in the reporting unmet needs between time point one and two.        6. To establish if there are any characteristics of breakthrough pain, such as the          frequency or severity of pain episodes, that have an association with prevalence and the          severity of the unmet supportive care needs reported by patients with breakthrough pain          caused by their cancer or cancer related treatments. Factors will be identified by the          Breakthrough pain Assessment Tool (BAT).   "
124819|NCT01651897|"     Delirium occurs in 10% of older emergency department (ED) patients, yet it remains poorly     understood. To date, the predominance of delirium studies have been conducted in hospitalized     patients and therefore have limited generalizability to the ED. Understanding ED delirium's     natural course and its effect on outcomes is not well characterized. The investigators     hypothesize that a significant proportion of patients who are delirious in the ED will remain     delirious in the hospital, and persistent cases of ED delirium will be significantly     associated with higher 6-month mortality and accelerated functional decline. To test this     hypothesis, the investigators will perform a prospective cohort study that will enroll 150     older ED patients with delirium and a random selection of 150 older ED patients without     delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED,     the investigators will assess patients for 7 days during hospitalization and perform phone     follow-up at 6-months.   "
124820|NCT01651884|"     The purpose of this study is to assess the changes in language processing of patients with     chronic aphasia after receiving non-invasive brain stimulation.Previous research using     traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has     shown that persons with aphasia show more improvement after treatment when that treatment is     accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver     current to more specific locations in the brain. This new delivery method is called     high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse     current delivery) or HD-tDCS (more focal current delivery) will be the better approach for     enhancing treatment outcomes. To answer this question, computerized speech-language treatment     will be administered during the application of the different forms of brain stimulation.   "
124821|NCT01651871|"     The primary objective of the study was to examine the efficacy and safety of     S-555739/cetirizine HCl compared with the individual components and placebo.   "
124822|NCT01651858|"     The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy     male volunteers.   "
124823|NCT01651845|"     The investigators have recently developed an innovative optical molecular imaging platform     (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a     hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact     means of obtaining instantaneous image-based measurements of diagnostically-relevant     biological and molecular information of a wound and surrounding skin tissues for the first     time and could have significant impact on improving conventional wound care, management, and     guidance of intervention. In preliminary preclinical testing, the investigators have     discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the     connective tissue matrix emit a characteristic green fluorescent signal, while most     pathogenic bacterial species emit a unique red fluorescence signal due to the production of     endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast agents     are needed during imaging, making this approach particularly appealing as a diagnostic     imaging method for clinical use.      Based on extensive preclinical studies in our labs, PRODIGI has demonstrated its capability     at collecting autofluorescence images of wounds and detecting the presence and relative     changes in connective tissue (e.g. collagen) content and bio-distribution involved in wound     healing. It can also detect the presence and relative amounts of commensal and pathogenic     bacteria within the wound based on autofluorescence alone (these bacteria are invisible to     standard visualization with the naked eye using white light), thus providing a measure of     infection status. This could significantly impact clinical wound care and management by i)     reducing the complications associated with missed detection of bacterial infection under     conventional practice, ii) facilitating image-guided wound sampling by targeted     swabbing/biopsy and iii) monitoring wound healing and treatment response over time.      Previous Related Studies: A pilot-level clinical study (UHN REB protocol # 09-0015-A, PI:     DaCosta, 50 patients imaged to date) performed by our group from 2008-2011 to assess the     clinical utility of the device successfully demonstrated that tissue autofluorescence     produced by endogenous collagen/elastin in the skin appears green in the fluorescent images,     while most clinically-relevant bacterial colonies present in the wound produce a red     fluorescence signal caused by endogenous porphyrins. Some bacterial species (e.g. pseudomonas     aeruginosa) produce a green fluorescence signal that can be differentiated spectrally and     texturally from the fluorescence of the dermis (another hue of green, discernable by our     proprietary image analysis software). The PRODIGI device is sensitive enough to detect these     green and red fluorescence signals from tissue and bacteria confirming the utility of this     compact and portable imaging platform for clinical wound care.      The investigators hypothesize that real-time imaging of tissue autofluorescence signals     emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within     complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound     closure), detect wound bacterial contamination and/or infection that is occult under standard     clinical white light evaluation, and guide intervention during wound care.   "
124824|NCT01651832|"     Aim of the study is to increase the proportion of indicated patients with colorectal cancer     undergoing adjuvant chemotherapy following surgical resection through an optimized symptom     management and logistical support.   "
124825|NCT01651819|"     Urological physical therapy is described to improve urinary symptoms in patients with     myelopathy or neurological dysfunction and to increase the quality of life. Although it was     never tested on HTLV-1 associated overactive bladder syndrome, an disabling disease that is     common seen in HAM/TSP patients but can also appear as an isolated form. Our hypothesis is     that urological physical therapy can improve urinary symptoms like incontinence, urgency and     nocturia in HTLV-1 infected population with those complains.   "
124826|NCT01651806|"     Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious     than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This     includes having a greater impact on decreasing blood loss without increasing the occurrence     of adverse thromboembolic events in patients undergoing primary, elective total knee     arthroplasty.      Secondary - TA will decrease blood loss more effectively in women than in men undergoing this     procedure.   "
124827|NCT01651793|"     The purpose of this study is to determine which substances in cocoa produces changes in     mental energy. This is a double blind study. The primary outcome measures are performance on     tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at     pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of     mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions     are the following:      Active comparator 1 High flavanol, high theobromine, high caffeine, single dose     administration in hot water vehicle Active comparator 2 High flavanol, high theobromine, low     caffeine, single dose administration in hot water vehicle Active comparator 3 Low flavanol,     high theobromine, high caffeine, single dose administration in hot water vehicle Active     comparator 4 Low flavanol, low theobromine, high caffeine, single dose administration in hot     water vehicle Inactive comparator No flavanol, no theobromine, no caffeine, single dose     administration in hot water vehicle   "
124828|NCT01651780|"     The objective of this study is to assess the safety and efficacy of using bivalirudin instead     of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The     primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with     heparin in TAVR procedures. Results for all participants enrolled into the randomized trial     (BRAVO 3) are presented.   "
124829|NCT01651767|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what     the body does to the medication) and antiviral activity of JNJ-47910382 when administered in     different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.   "
124830|NCT01651754|"     Postcancer fatigue (PCF) is a frequently occurring, severe and invalidating problem,     impairing quality of life. Patients with chronic fatigue syndrome (CFS) also suffer from     severe fatigue symptoms. Although it is possible to effectively treat CFS, the nature of the     underlying physiology remains unclear. The presence of an underlying immunological problem     has been suggested as an explanation for PCF and CFS. The aim of this study is to compare the     humoral and cellular immune responses upon influenza vaccination in PCF patients, CFS     patients, non-fatigued cancer survivors, and healthy controls.      PCF (n=20) and CFS patients (n=20) will be vaccinated against influenza. Age and gender     matched non-fatigued cancer survivors (n=20) and healthy controls (n=20) will be included for     comparison. Antibody responses will be measured at baseline and at day 21 by a     hemagglutination inhibition test. T cell responses will be measured at baseline and at day 7     by lymphocyte proliferation, activation, and cytokine secretion.   "
124831|NCT01651741|"     The aims of this study are to investigate the effect of seaweeds which is one of the main     ingredients of Korean traditional food 'Kimchi' and probiotics on intestinal function of     healthy subjects.   "
124832|NCT01651728|"     The objective is to assess the effect of simvastatin on immunology, inflammatory, and     coagulation responses, and mortality in elderly with pneumonia based. The primary outcome is     mortality event.      The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly     with pneumonia.   "
124833|NCT01651715|"     The purpose of this study is to determine whether early self-treatment with homeopathic     dilutions of oral antibodies to a key-protein of the immune system are effective and safe in     the treatment of viral upper respiratory tract infections   "
124834|NCT01651702|"     Three dimensional anatomical mapping is an established method facilitating ablation of     cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster,     Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA).     These two systems has been compared in only a few studies. Recent technical advances resulted     in the development of new versions of both systems. To the best of the investigators     knowledge no studies have been performed for direct comparison of the newer versions of these     two systems. The aim of the study to compare two systems for the use in the ablation of     complex arrhythmias.   "
124838|NCT01651650|"     Phase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile     through the NEXThaler® device in adult asthmatic patients with varying degrees of disease     control.   "
124839|NCT01651637|"     The aim of this study is to investigate the safety and tolerability of intratracheal     administration of two different single doses of CHF 5633 in preterm neonates with RDS in     terms of adverse events, adverse drug reactions, hematology and biochemistry values, the     incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and     mortality.   "
124840|NCT01651624|"     RATIONALE: Computed tomographic colonography (CTC) has proven to be accurate in detecting     colorectal neoplasms and may be a primary test in colorectal cancer screening.      PURPOSE: This clinical trial will compare participation rate, diagnostic yield and costs of     computed tomographic colonography, faecal occult blood test (FOBT) and colonoscopy (CO) as a     primary screening test in a population-based programme.   "
124841|NCT01651611|"     The purpose of this study is to determine whether public housing residents trained in Tobacco     Cessation and Motivational Interviewing Techniques to become Tobacco Treatment Advocates(TTA)     will be effective in increasing the quit rate of smokers in Boston Public Housing. The     investigators hypothesize that smokers that receive multiple TTA visits will be more likely     to (1) use smoking cessation resources and (2) quit compared to smokers who receive a single     visit.   "
124842|NCT01651598|"     In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of     multiple dose administration of BI 144807 will be investigated in otherwise healthy,     controlled asthmatic patients   "
124843|NCT01651585|"     The infection with cytomegalovirus (CMV) is the first cause of congenital neurological     handicap of infectious origin. It is probable that the néonatale viral load is correlated     with becoming of infected new-born babies. Among the active antiviral treatments against CMV,     valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the     pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to     evaluate it in a study. Decrease the fœtal viral load could make possible to decrease     symptomatology néonatale in a group of infected fœtuses.   "
124844|NCT01651572|"     The purpose of this study is to determine the incidence of post-operative residual     curarization in our patients and to determine if Cisatracurium and Rocuronium behave     differently from each other in terms of residual curarization.   "
124845|NCT01651559|"     This is a two-center study aimed to assess the efficacy of Dead Sea Minerals in alleviating     symptoms of Psoriasis Vulgaris, in 50 patients undergoing phototherapy. A bilateral left     right comparison will be made, after using the study product and the placebo, for 8 weeks,     twice daily, on each of the body sides (left right). In addition to the clinical evaluations,     skin biochemistry will be studied using non-invasive techniques. The latter will be     correlated with the clinical results of the patients. These will serve for future development     of diagnostic assays and personalized therapies.   "
124846|NCT01651546|"     The aim of the study is to create and validate a specific test named Intermittent     Catheterization Acceptance Test (I-CAT), assessing the acceptance of clean intermittent     self catheterization (CISC) in a neurological and no neurological population with indication     to self catheterization.      CISC avoids urological complications in bladder with chronic and improves quality of life.     Despite theses challenges, the learning of CISC can face some physical, cognitive and     psychological difficulties. Recently, we have validate a new test for predicting the physical     and cognitive abilities to practice CISC named PP-Test. Meanwhile, psychological factors     are not explored in this test. To our knowledge, no study has been conducted in order to     demonstrate in a prospective trial, which kind of psychological barriers can exist. Likewise     it would be interesting to create a new test assessing the psychological acceptance of the     patients to CISC before learning (I-CAT). Based on the results of this self-assessment test,     the specific nurse could then change her speech by playing down the importance of some fear     and anxiety described by the patients. The learning of CISC would be facilitated.   "
124847|NCT01651533|"     Stroke is the leading cause of disability in the United States, producing motor impairments     that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is     particularly disabling, is the primary impairment underlying stroke-related disability, and     the most frequent impairment treated by therapists in the United States. This study will test     efficacy of a promising technique in reducing arm disability and increasing function, thereby     improving outcomes and health, reducing care costs, for community dwelling patients with     stroke-induced hemiparesis.   "
124848|NCT01651520|"     In this study the investigators will use PET and 11C-Flumazenil to visualize and quantify     neuronal injury in the cortex and the deep gray matter of Multiple Sclerosis patients at an     early stage. The investigators will follow up patients to determine the prognostic value of     this neuronal injury.   "
124849|NCT01651507|"     this is a multicenter retrospective study on patients with pulmonary LCH who were     sequentially evaluated by concomitant lung HRCT and lung function testing. The objectives of     this study were: 1) to determine the changes over time of lung function parameters in     patients with pulmonary LCH; 2) to compare the variations of HRCT and lung function results     during follow-up; 3) to address the respective interest of these investigations for     identifying the patients who eventually will experience a progression of their disease.   "
124850|NCT01651494|"     This study will be a double-blind, randomized, placebo-controlled study of a single dose     (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be     randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the     inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the     inpatient clinic for the duration of dosing and one day after dosing, they will be required     to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and     90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse     events and clinical observations.   "
124851|NCT01651481|"     The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg)     and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102   "
124852|NCT01651468|"     Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to     assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice,     Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation     system.   "
124853|NCT01651455|"     The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2     different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.   "
124854|NCT01651442|"     Chronic insomnia is a prevalent disorder associated with increased health care costs,     impaired functioning, and an increased risk for developing serious psychiatric disorders.     Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications     are the most widely supported approaches for insomnia management. Unfortunately, few studies     have compared the psychological/behavioral therapies and BzRAs for insomnia treatment.     Moreover, insomnia treatment studies have been limited by small, highly screened study     samples, fixed-dose and fixed-agent pharmacotherapy strategies that do not represent usual     adjustable dosing practices, relatively short follow-up intervals, and reliance on     self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more     clinically relevant indicators of remission. Finally, studies have yet to test the benefits     of treatment sequencing for those who do not respond to initial their insomnia therapy. This     multi-site project will address these limitations. Two study sites will enroll a total of 224     participants who meet broad criteria for a chronic insomnia disorder, and a sizeable portion     (60%) of this sample will have insomnia occurring comorbid to a psychiatric disorder.     Participants will be evaluated with clinical assessments and PSG, and then will be randomly     assigned to first-stage therapy with an easy-to-administer behavioral insomnia therapy (BT)     or zolpidem (most widely prescribed BzRA). Centrally trained therapists will administer     therapies according to manualized, albeit flexible, treatment algorithms. Initial outcomes     will be assessed after 6 weeks, and treatment remitters will be followed for the next 12     months on maintenance therapy. Those not achieving remission will be offered re-randomization     to a second, 6-week treatment involving pharmacotherapy (zolpidem or trazodone) or     psychological therapy (BT or cognitive therapy-CT). All participants will be re-evaluated 12     weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing     their final treatment. Insomnia remission, defined categorically as a score < 8 on the     Insomnia Severity Index, will serve as the primary outcome for treatment comparisons.     Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of     sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Our     over-arching goal is to obtain new information that aids in the development of clinical     guidelines for managing insomnia sufferers with and without comorbid psychiatric conditions.   "
124855|NCT01651429|"     Resilience is the ability to cope effectively and adapt to a wide range of stressful     environmental challenges. Sleep loss has been shown to reduce activity in the brain regions     responsible for resilience. The ability to resist the effects of sleep loss appears to be a     stable, trait-like quality. This study will attempt to predict individuals' trait-resistance     to sleep loss based on their neurobiology.   "
124871|NCT01651221|"     Increasing exposure to a single orosensory cue without ingestion of additional energy may     promote an increased rate of habituation, more rapid satiation, and reduced intake. This     exposure can occur via smell (olfactory) and taste (gustatory) systems.It is not clear if     repeated exposure via the combined olfactory and gustatory systems increases the rate of     habituation more so than repeated exposure through one of these systems. Thus, the purpose of     this investigation is to examine the amount of salivation occurring in 12 trials of exposure     to a food via the olfactory, gustatory, and combined olfactory and gustatory systems. The     primary dependent variable will be the amount of salivation in the 12 trials. It is     hypothesized that a more rapid decrease in salivation will occur across trials in the     combined olfactory and gustatory exposure as compared to the other two conditions, indicating     a more rapid rate of habituation.   "
124856|NCT01651416|"     In areas of Africa where malaria is only a problem during a short rainy season, monthly     courses of antimalarial drugs can provide very effective prevention of malaria in children.     This approach, called intermittent preventive treatment in children (IPTc) but now known as     Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where     malaria is transmitted for longer each year. It is uncertain if IPTc would be effective,     acceptable to communities or sustainable when delivered over a longer period, but this is an     important public health question of key interest to policy makers, because in areas with a     longer transmission season, the burden of malaria is typically higher than in highly seasonal     areas.      Another form of prevention that would be operationally easier for African countries to put     into practice would be to treat malaria patients with long-lasting antimalarials, which     protect children against further malaria episodes for several weeks. Because malaria     disproportionately affects certain high risk children more than others, causing repeated     attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and     effective way to target limited resources at the individuals who most need protection. This     may be particularly beneficial where malaria is a seasonal problem, because repeated malaria     attacks will not only be borne by a few unfortunate children, but will also occur close     together in time.      The investigators propose a clinical trial to evaluate these two forms of chemoprevention in     Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years     of age currently have access to diagnosis and treatment of malaria via by community based     health workers. Children enrolled in the study will receive either the standard     community-based diagnosis and treatment, treatment with a longer-acting artemisinin     combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria     chemoprevention (SMC) during the peak in transmission.   "
124857|NCT01651403|"     This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir     disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B     infection. While studies have shown significant virologic response in adults and adolescents,     the effect in children is not well established. This study will provide valuable data that     can help establish the efficacy and safety profiles of TDF in children. The study will     consist of 48 weeks of blinded randomized treatment, after which participants will switch to     open-label TDF treatment for an additional 144 weeks.   "
124858|NCT01651390|"     To determine in a randomized controlled trial (RCT) whether percutaneous coronary     intervention - in patients with in-stent restenosis in either bare metal stents or drug     eluting stents - with the Pantera Lux balloon is angiographically non-inferior to     percutaneous intervention with the Orsiro stent 6 months post-procedure.   "
124859|NCT01651377|"     The purposes of this study are as follows: 1. To assess the cardiovascular and subjective     effects of cocaine during treatment with pramipexole and placebo. 2. To assess the     reinforcing effects of cocaine, measured using choice procedures, during treatment with     pramipexole and placebo.   "
124860|NCT01651364|"     The purpose of this study is to determine the effects of treatment with cabergoline, compared     to treatment with placebo, on cocaine induced craving and subjective effects in     cocaine-dependent human volunteers.   "
124861|NCT01651351|"     The purpose of this study was to generate sufficient safety and tolerability information in     support of an increase in the infusion rate of intravenous GLASSIA in the prescribing     information from 0.04 to 0.2 mL/kg/min.   "
124862|NCT01651338|"     Chronic pains can affect the life quality. This study has performed in the first time in     Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life     quality of 150 patients who suffered from chronic pain. Some people like performing     acupuncture because they believed it's free of risks and beneficial.      In order to achieve this purpose, we had examined the life quality of the patients before and     after acupuncture. This study was randomly performed on 150 patients aged between 17-75. They     were suffering from chronic pain.      The questionnaire is based on WHO QOL. The questionnaires were filled out once before     acupuncture and once 12 weeks after it.   "
124863|NCT01651325|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.   "
124866|NCT01651286|"     Recently, the investigators demonstrated that nasal route ventilation is superior to the     nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The     investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask     ventilation during the induction of general anesthesia by: 1) producing a better seal than     full face mask, and 2)establishing a greater airway patency and more effectively ventilate     than full face mask ventilation. The investigators intend to test this hypothesis on adult     patients during the induction of general anesthesia in the absence of muscle relaxation.   "
124867|NCT01651273|"     The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in     patients with high cholesterol.   "
124868|NCT01651260|"     Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the     nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may     result in accidental slippage of the tube into a mainstream bronchus or into the pharynx.     Hollister Incorporated is assessing the functionality and performance of an endotracheal tube     securement device.   "
124869|NCT01651247|"     This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals'     Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant)     and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus     Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine     products. The samples have been collected at pre-determined time points from a subset of     subjects who participated in selected studies [217744/085 and 213503/048] conducted in the     United States.   "
124870|NCT01651234|"     The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD     f\profile.   "
124872|NCT01651208|"     The purpose of this study is to evaluate if the use of a phone based motivational     interviewing among minority populations who received a coronary stent can improve adherence     to antiplatelet agents from approximately 51% to 66% (15 percentage point increase) at 12     months post stent placement when compared to a mailed educational DVD.   "
124873|NCT01651195|"     The purpose of this study is to evaluate the effect of regular consumption of probiotic     tablets in preventing illnesses in Finnish healthy adults attending military service.   "
124874|NCT01651182|"     Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss     and blood transfusion requirements in the following patient populations: multisystem trauma,     liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver     resection are at risk of severe perioperative blood loss and may also benefit from     perioperative TXA administration.      This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic     properties of two well studied dosing regimens of TXA will provide guidance in determining     the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling     evidence of the effectiveness of TXA comes from the large multicentred, multi-national     CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver     transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h     from the start of surgery until 2 hours after reperfusion of the liver transplant.      Although TXA is not currently approved for use in patients undergoing major liver resection,     Health Canada has allowed the use of tranexamic acid for use in this research study.   "
124875|NCT01651169|"     Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols     have shown that a conditioning TMS pulse applied to the human motor cortex changes the     excitability of motor pathways from the motor cortex to spinal motorneurons. These effects     depended on the stimulus intensity of both conditioning and test pulse and also the ISI). A     characteristical sequence of inhibition (short interval cortical inhibition [SICI],     GABA-Aerg), facilitation (intracortical facilitation [ICF]), and inhibition again (long     interval cortical inhibition [LICI], GABA-Berg) is thought to be physiologically involved in     motor control. Previous studies have also shown that neuronal inhibitory motor circuits are     also disturbed in ADHD which will be restored by using methylphenidate. In this study the     investigators sought to investigate if methamphetamine abuse (from the same chemical class of     medications) will alter such effects of methylphenidate.   "
124876|NCT01651156|"     A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the     efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid     retention caused by congestive heart failure) based on the conventional therapy.      To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients     with body fluid retention after current diuretic treatment, after continuous treatment of 7     days' oral Tolvaptan 15mg or placebo.   "
124877|NCT01651143|"     Primary Objective:      - To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients     with diffuse cutaneous systemic sclerosis.      Secondary Objectives:        -  To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis          as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor          signaling markers in blood and skin;        -  To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis          as measured by the modified Rodnan Skin Score (mRSS);        -  To explore the effect of SAR100842 on quality of life as measured by the Scleroderma          Modified Health Assessment Questionnaire (SHAQ);        -  To document long term safety of SAR100842 during the extension part.   "
124878|NCT01651130|"     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the     most common uterotonic drug used to prevent and treat PPH in North America, however, there     are some limitations to its use. Oxytocin has a very short duration of action, which requires     a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians     and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of     carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post     partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts     4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater     efficacy rate. However, a dose response study to determine the minimum effective dose of     carbetocin has not yet been published. The investigators hypothesize that the minimum     effective dose (ED90) is at least 20mcgs (or perhaps below) in women undergoing elective     Cesarean delivery.   "
124879|NCT01651117|"     The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race     population of poorly controlled diabetic Veterans. Also, the study aims to assess the effects     of becoming a mentor on those who originally were mentees. It is expected that participants     in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of     race or ethnicity at the end of the intervention.   "
124880|NCT01651104|"     To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted     influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response     to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and     hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly     subjects in compliance with the requirements of the current EU recommendations for clinical     trials related to yearly licensing of influenza vaccines.   "
124881|NCT01651091|"     The purpose of this study is to investigate the effects of an eight-week long group-based     secular intervention known as Meditation Awareness Training (MAT) on psychosocial functioning     in prison participants.   "
124882|NCT01651078|"     The need for new technologies and devices in the field of neurosurgery is well established.     In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy     tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue     caused by tumors and lesions. This post-marketing, multi-center study will include patients     with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for     NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and,     where feasible, healthcare utilization data for publication.   "
124883|NCT01651065|"     The purpose of this randomized trial is to study the efficacy of a novel social propagation     intervention which integrates social network induction with health education for weight and     metabolic control among patients with type 2 diabetes, BMI of 25-30+, and cardiovascular     disease. The intervention takes place in the form of a community health program, where     participants who enroll in this program will be asked if they would like to take part in the     study to evaluate its efficacy. Thus, the investigators will study the efficacy of social     networks in propagating changes in lifestyle factors for diabetes and chronic disease     management   "
124885|NCT01651039|"     The purpose of this clinical research study is to find out the effects of a drug called     panobinostat (LBH589) when given to people like you with multiple myeloma in combination with     the drugs lenalidomide and dexamethasone. The safety of this combination of drugs will also     be studied. Your physical state, changes in the state of your multiple myeloma, and     laboratory findings taken while on-study will help us decide if panobinostat combined with     dexamethasone and lenalidomide is safe and effective.      This goal of this study therefore is to determine the activity of the combination of     panobinostat thrice weekly every other week, lenalidomide, and weekly dexamethasone in a     similar group of subjects. The doses of lenalidomide and dexamethasone will be that which is     approved by the FDA for multiple myeloma and you will take each drug at a specific frequency     over a 4 week (28 day) period. This period is called a study cycle.   "
124886|NCT01651026|"     The purpose of this study is to describe the diagnostic and treatment procedures employed for     patients with rectal cancer in each participating center. Outcomes to treatment, costs of     treatment will be described. Exploratory analyses will be done to identify factor that     influence patient prognosis, as well as factors that predict patient response to treatment.   "
124887|NCT01651013|"     The purpose of this study is to describe the treatments received and outcomes of patients     with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of     the tumor, and to describe the costs of treatments. Information will also be collected     regarding risk factors, variables among treatment centers and patients, and explorative     analyses will be done to try to identify factors that impact prognosis and factors that     predict tolerability and response to treatment.   "
124888|NCT01651000|"     This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact     parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and     tolerability of CTAP101 will also be evaluated   "
124889|NCT01650987|"     Evaluate the toxicities of cervix and corpus uteri carcinomas treatment   "
124890|NCT01650974|"     The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen     therapy during diagnostic bronchoscopy.   "
124891|NCT01650961|"     The purpose of this study is to assess the effects of palonosetron on corrected QT interval     duration during and after general anesthesia.   "
124892|NCT01650948|"     Patients with AMD will provide cheek cell samples to determine if their is a correlation     between genotype (DNA markers) and phenotype (the type of AMD the patient has).   "
124893|NCT01650935|"     Oxalate restricted diet is routinely prescribed in clinical practice of nephrolithiasis     patients with hyperoxaluria. The effect of dietary oxalate on urinary oxalate is however     controversial. Some studies do not implicate dietary oxalate as a major risk factor for     nephrolithiasis. The Dietary Approaches to Stop Hypertension (DASH) diet, which is high in     fruits and vegetables, moderate in low-fat dairy products, and low in animal protein     represents a novel potential means of kidney stone prevention. The effect of a DASH-style     diet on relative urinary supersaturations is however uncertain. Higher consumption of fruits     and vegetables may increase urinary oxalate but also increases urinary citrate, an important     inhibitor of calcium saturation.All the above data lead us to hypothesize that a DASH diet     other than an oxalate restricted diet, which is routinely administered in clinical practice,     might be beneficial in lowering urinary relative supersaturations of calcium oxalate in     recurrent stone formers with hyperoxaluria.      Recurrent stone formers with hyperoxaluria (urine oxalate>32.8) are allocated into 2 groups.     The first group is prescribed an oxalate restricted diet. The second group are asked to     follow a calorie-controlled DASH diet plan while drink water in the same amounts. 24-h urine     is collected 2 times before study visits at baseline, 1 time on week 6 and 2 times at the end     of the study.   "
124894|NCT01650922|"     To look for patterns of polymorphisms in DNA repair in both germline and tumor cells samples.   "
124957|NCT01650103|"     The purpose of this study is to verify any existing relationship between mixed oxygen     saturation (from central venous catheter) and urinary sodium, potassium, chloride in     determining the volemic state and renal perfusion of patients undergoing major surgical     interventions.   "
124895|NCT01650909|"     This study is an independent sub-study of the protocol titled PKU-016: A double-blind,     placebo-controlled, randomized study to evaluate the safety and therapeutic effects of     sapropterin dihydrochloride on neuro-psychiatric symptoms in subjects with phenylketonuria     (PKU ASCEND).      The primary objective of this study is to determine oxidative stress in patients with     classical phenylketonuria (PKU) enrolled in PKU-016, using a brain scan (called an HMPAO     SPECT) at baseline and 26 weeks, and blood redox biomarkers.   "
124896|NCT01650896|"     The typical delirium study between 1989 and 2005 compared delirium management in a specialty     unit such as geriatric medicine with delirium management in general medicine (in most cases     the research diagnosis of delirium was not communicated to the general medicine group). This     study will provide open diagnosis of delirium by the CAM to both the geriatric medicine and     general medicine groups (medical staff, patients, families) plus daily monitoring of delirium     using digit span and delirium index which is reported to both patient groups. It will also     compare confusion assessment method (CAM)to a novel diagnostic system of Paul Regal with     respect to hard endpoints (survival and return home). Hypotheses: 1) General medicine can     manage delirium as well as geriatric medicine when delirium is openly diagnosed and monitored     daily (even in speciality units it is rare to find daily measurement of tools such as     delirium index); 2) The Regal diagnostic system will be superior to the CAM in predicting     hard endpoints (survival and return home rate for patients living in the community).   "
124897|NCT01650883|"     The purpose of this study is to determine whether one of two Vitamin D3 (cholecalciferol)     oral treatment regimens is superior to the other in normalizing Vitamin 25 OHD serum levels.     While these two regimens in the end provide equal total dosing, the two arms differ in     frequency and dosing during a 40 day treatment plan. The primary endpoint will be a direct     comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a     paired T-test. Secondary endpoints include record of adverse events throughout the 40 day     study period as well as changes in basic laboratory values including CMP and ionized Calcium.      The investigators hypothesize that the Cholecalciferol (Vitamin D3) daily dosing arm of 5000     IU daily will result in more efficient replacement as compared to the 50,000 IU dosing given     every 10 days. Our goal will be to achieve a serum Vitamin 25 OH D level of > 50 mg/dL at day     40. The investigators propose that 75% of the subjects on daily Vitamin D3 will achieve this     level and that 35% of the subjects in the every 10 days dosing arm will reach this goal.   "
124900|NCT01650844|"     This project aims to improve guideline-based asthma care using enhanced communication and     screening tools, telemedicine and directly observed therapy of preventive medications in city     schools. Web-based screening will be used to identify children with persistent or poorly     controlled asthma and to send reports to the child's primary care doctor. Children in the     SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a     daily preventive asthma medication to be taken through school-based directly observed     therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for     improving guideline based care, enhancing adherence to effective preventive medications and     at reducing morbidity among young urban children with asthma.   "
124901|NCT01650831|"     The purpose of this study is to confirm equivalence of a new generation breath analyzer     (Modified BreathID) in its ability to detect H. pylori compared to the currently approved     BreathID® System.   "
124902|NCT01650818|"     The purpose of this study is to compare the safety and the effects of moderate-intensity     aerobic endurance training to those of an usual physical therapy intervention on exercise     capacity and quality of life in patients with amyotrophic lateral sclerosis (ALS).   "
124903|NCT01650805|"     The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients     with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.   "
124904|NCT01650792|"     The main purpose of the study is to determine noninvasive markers of brain involvement in     Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on     transcranial Doppler monitorization, the investigators aim to determine the efficacy and     safety of aspirin in preventing microembolization in patients with no previous history of     stroke. Specific aims are listed bellow:      (1) to establish brain magnetic resonance imaging markers of stroke risk in patients with     Chagasic heart failure (HF); (2) to determine whether biomarkers can predict stroke risk in     patients with Chagasic HF; and (3) to evaluate the efficacy of antiplatelet treatment in     decreasing microembolization rate in patients with Chagasic HF.   "
124905|NCT01650779|"     This is an exploratory study to evaluate changes in glycosphingolipid levels and other     (exploratory) Fabry disease parameters in male Fabry disease participants who were previously     treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks     (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.   "
124906|NCT01650766|"     The primary purpose of the study is to investigate the correlation between the efficacy and     toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS),     dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).   "
124907|NCT01650753|"     Healthy adults referred to as the absence of intestinal disorders, liver and kidney problems,     lactose intolerance, and no use of ongoing medication for chronic diseases will be recruited.     This research study will test the persistence of the probiotic (healthy bacterial) strain     Bifidobacterium longum spp. longum in the human gastrointestinal tract after it is consumed,     how it is tolerated, and its interactions with other micro-organisms already present in your     gastrointestinal tract. The strain used is similar to bacteria used in probiotic yogurts, and     the species Bifidobacterium is generally regarded as safe. The patient will be asked to will     be consume a probiotic powder containing Bifidobacterium longum spp. longum strain AH1206 and     a placebo in a random order, with neither the patient nor the investigators knowing the     identity of the preparations given. Persistence or presence of the probiotic strain will be     based on analysis of fecal (stool or bowel movement) samples provided.   "
124958|NCT01650090|"     To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in     delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission     following one or two prior pulmonary relapses.   "
124959|NCT01650077|"     Non-interventional study consisting of a population of patients who had received for soft     tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after     failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.   "
124908|NCT01650740|"     In recent years, there has been growing evidence that antidepressants are only marginally     effective compared to placebo for mild to moderate depression. In other words, although many     people improve when they take antidepressant medications, almost as many get better with     placebo pills. One possible solution to this problem would be to give patients a trail of a     placebo prior to giving them an antidepressant, however there are ethical issues with doing     this deceptively. New evidence from other placebo-responsive disorders such as irritable     bowel syndrome shows that people may benefit from placebos even if they know they are taking     them. This study aims to determine whether giving placebos without deception to people with     major depressive disorder followed by the option to switch to an antidepressant is an     effective strategy. There will be 3 groups of subjects. The first group is a standard     treatment arm and will receive duloxetine, an antidepressant. The second will be given a     placebo with the option to switch to duloxetine if they do not improve. The third group will     receive supportive clinical visits the option to switch to duloxetine if they do not improve.     This design will allow us to determine whether a sequenced treatment of a placebo without     deception and then the option to switch to an antidepressant is a viable strategy. It will     also help us to determine to what degree the benefit comes from the ritual of receiving and     taking the placebo tablet versus the benefit of visits with a doctor alone. The primary     hypothesis is that there will be a less than 5% difference between response rates after 12     weeks in the sequenced placebo-then-antidepressant treatment group (both subjects who have     remained on placebo as well as those who have switched to the antidepressant will be     considered as one group) compared to the immediate antidepressant therapy group.   "
124909|NCT01650727|"     The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib     therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small     lymphocytic lymphoma (SLL).   "
124910|NCT01650714|"     The proposed study will assess the efficacy and safety of the innovative endoscopic technique     for the acquisition of full thickness gastric muscle wall biopsies. Having access to full     thickness biopsies will allow an increased understanding of the pathophysiology of     gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis,     pseudoobstruction and other motility disorders. This information is essential to development     of more targeted and effective therapy than currently available. Despite the high prevalence     of functional gastrointestinal disorders and its significant impact on social and health care     costs, the underlying cause is not well understood and there is no effective specific     treatment to successfully alleviate patient symptoms.   "
124911|NCT01650701|"     The purpose of this study is to find out if lenalidomide when given along with rituximab can     help to control the disease and also increase the length of your response (complete or     partial response) compared to the standard of care rituximab chemotherapy treatment.   "
124948|NCT01650220|"     This is an observational study designed to determine whether veterans with PTSD have a higher     risk of heart disease than those without PTSD. Cardiovascular risk will be assessed by     interview and review of medical records, carotid artery ultrasound, and blood tests measuring     markers of inflammation. Study participation is approximately 6 months. The eligible study     population is veterans of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF),     age 28 through 38 years.   "
125164|NCT01647282|"     The purpose of this study is to determine the effect of local application of minocycline     microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed     with moderate-severe chronic periodontitis within a periodontal maintenance program.   "
124912|NCT01650688|"     Epiblepharon is a very common condition among Asian children and is a fold of the skin and     underlying pretarsal orbicularis muscle that overlaps the eyelid margin and pushes the lashes     against the cornea. It is manifested by the anterior lamella overriding the posterior lamella     which causes the lashes to brush against the cornea. Although the prevalence of epiblepharon     is known to be high among Asians, its cause remains controversial. Several etiological     factors may be involved in the pathogenesis of epiblepharon.      Although epiblepharon in the lower lids lessens and disappears with age in many cases,     surgery must be performed at an early age in severe cases in order to prevent ocular trauma     as the vertically oriented cilia of the lashes can erode the corneal epithelium. Induced     keratitis and astigmatism are indications for surgical intervention.      Over our many years of surgical experience, the investigators came to realize that the     severity of epiblepharon was reduced when patients were under general anesthesia during     surgery. The purpose of this study was to investigate the role of the orbicularis muscle in     the pathogenesis of lower lid epiblepharon and to analyze the differences in the severity of     epiblepharon in the upright versus the supine position and before and after the induction of     general anesthesia.   "
124913|NCT01650675|"     The purpose of this study is to assess the validity of an indirect computer-delivered     screener for drug use and assess the efficacy of a computer-delivered brief intervention with     urban post-partum women at-risk for substance abuse and HIV during the post-partum period.   "
124914|NCT01650662|"     Infarct size is a major determinant of prognosis after myocardial infarction (MI). It has     been reported that Cyclosporine A (CsA) administered immediately prior to percutaneous     coronary intervention (PCI) significantly could reduce reperfusion injury and consequently     infarct size in ST elevation MI (STEMI) patients.      CYCLE trial is a multicenter, controlled, randomized open label study, with blind assessment     of endpoint measures. The objective is to determine whether a single i.v. dose of CsA within     6 hour onset of symptoms of STEMI in 444 patients, improves outcomes after successful primary     PCI, by reducing myocardial injury associated to reperfusion.   "
124915|NCT01650649|"     The primary objective of this study is to assess QTc (an interval of the heart rhythm)     interaction effects between lofexidine and methadone. The secondary objectives of the study     are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring     pharmacokinetics (amounts of drug in the blood), vital signs (heart rate and blood pressure)     and adverse events (side effects) when co-administered with methadone; to describe effects on     opiate withdrawal when lofexidine is introduced following a 50% methadone dose reduction, as     required to elicit a withdrawal response; and to evaluate the QTc interaction effects of     lofexidine compared with placebo. The investigators hypothesize that while both agents     (lofexidine and methadone) are known to prolong the QTc interval, the combination of the     drugs will not create an additive effect which creates a significant safety concern. The     investigators further hypothesize that subjects will be able to tolerate the therapeutic dose     of lofexidine (0.8 mg four times daily) when the methadone maintenance dose is lowered to     elicit withdrawal.   "
124916|NCT01650636|"     The purpose of this study is to test the effects of a videotelephone-delivered     patient-partner dual-focused cognitive behavioral stress management intervention on chronic     fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in     patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that     videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM)     intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner     Health Information (PP-T- HI) condition.   "
124917|NCT01650623|"     The aim of this study is to compare two physical therapy training consisting of gait training     that are distinguished by one being associated with tasks that require handling of the main     executive functions, performed by individuals with Parkinson's Disease.      The investigators hypothesis is that the experimental group (EG), which hold gait training     with higher cognitive demands (dual-task condition), will make improvements in the parameters     measured (functionality of gait and cognitive ability) to a greater extent compared to the     control group (CG), which hold gait training without executive tasks (single-task condition).   "
124918|NCT01650610|"     The aim of this study is the development and implementation of a new protocol of a physical     therapy training, based on a gait training associated with executive tasks, for treatment of     individuals with Parkinson's Disease.      The hypothesis is that this group of patients who will carry out training of this study     protocol will show improvement in measured parameters (functionality of gait and cognitive     ability), which allows this protocol to be improved and published as a proposal of     physiotherapeutic treatment.   "
124919|NCT01650597|"     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     single ascending doses as well as repeated doses of JNJ-42165279 in healthy male     participants.   "
124920|NCT01650584|"     To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease     (DED)   "
124921|NCT01650571|"     Currently, standard wound care practice is suboptimal at assessing wound remodeling and     bacterial infection in real-time. An alternative and complimentary means of providing     real-time imaging of connective tissue re-modeling and bacterial infection may greatly     increase the early detection of infection thus leading to rapid therapeutic intervention. Our     new device, PRODIGI(TM), images tissue and bacterial autofluorescence (without agents) and     may provide this clinically-important capability.      In preliminary preclinical testing, the investigators have discovered that when wounds are     illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a     characteristic green fluorescent signal, while most pathogenic bacterial species emit a     unique red fluorescence signal due to the production of endogenous porphyrins. Therefore,     with autofluorescence imaging, no exogenous contrast agents are needed during imaging, making     this approach particularly appealing as a diagnostic imaging method for clinical use.      The investigators hypothesize that real-time imaging of tissue autofluorescence signals     emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within     complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound     closure), detect wound bacterial contamination and/or infection that is occult under standard     clinical white light evaluation, and guide intervention and wound care.   "
124922|NCT01650558|"     The purpose of this study is to determine if there is a benefit to taking     trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral     load suppression and a good clinical response on anti-retroviral therapy (ART). If there is a     benefit, then is it due to antimalarial or antibacterial properties.      The investigators hypothesize that there will be a long-term benefit on survival and disease     control in the context of prophylaxis and that the benefit will largely be attributed to     prevention of malaria. The main study hypothesis is that 1)TS and chloroquine (CQ) will     decrease the rates of morbidity and mortality among adults after 6 or more months of ART and     2) CQ prophylaxis will be associated with more prolonged viral suppression and higher CD4     cell counts than TS prophylaxis or no prophylaxis.   "
124923|NCT01650545|"     This is a single-center pilot study to investigate the efficacy and safety of aerosolized     liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients     with bronchiolitis obliterans syndrome (BOS).      The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the     treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary     end points.   "
124924|NCT01650532|"     The investigators propose to test the effects of an 8-week supervised, site-based, group yoga     intervention on cognition and functional fitness in older adults. The SAY Exercise study will     compare the yoga group to a stretching group to determine if the program improves attention     and cognition, reduces functional limitations, enhances functional performance in everyday     activities, as well as psychological health in sedentary older adults between 55-80 years of     age. The investigators also propose to assess heart rate variability using a 3-lead EKG and     salivary cortisol levels to understand the moderators of the yoga-cognition relationship.   "
124925|NCT01650519|"     The intent of this study is to assess the analgesic efficacy of IV ibuprofen when     administered at induction of anesthesia. Results from this pilot study will be used to design     and determine the appropriate statistical power for a larger, multi-center randomized study.   "
124926|NCT01650506|"     Extended phase 1 trial of combined metformin and erlotinib in advanced triple negative breast     cancer patients. The goals of the study are to establish the maximum tolerated combined     dosing of erlotinib and metformin as well as deciding if there is a potential clinical     utility of the combination in treating patients with triple negative breast cancer.   "
124927|NCT01650493|"     Three toothpastes will be compared, two toothpastes in each subject, to establish whether     changes in the depth or area of an artificially created area of tooth decay is the same for     each toothpaste.   "
124928|NCT01650480|"     The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD)     assessment, undertaken during or immediately after a hospital admission, which addresses the     holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).   "
124929|NCT01650467|"     The main objective of this study is to evaluate the existence of a relationship between the     presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence     of primary resistance to the treatment of CML by imatinib.   "
124960|NCT01650064|"     The purpose of this study is to estimate the survival proportion one year after surgery for     intertrochanteric fracture in older adults in Latin America.   "
124961|NCT01650051|"     The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets,     USP 200 mg as a short term analgesic treatment of pain upon urination associated with     Uncomplicated Urinary Tract Infections (uUTI).      The secondary exploratory objective is to evaluate safety and efficacy of Phenazopyridine HCl     Tablets, USP 200 mg as a short term analgesic treatment of burning upon urination associated     with uUTI.   "
124930|NCT01650454|"     The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the     aging of the population is a major issue of public health. The prevalence of sleep     disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by     prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening.     The presence of these sleep disturbances is the main reason for the institutionalization of     AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The     MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive     impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of     Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and     followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night     polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin     dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be     used.   "
124931|NCT01650441|"     The objective of this study is to evaluate the effect of the combination of formoterol and     beclometasone dipropionate in a dry powder inhaler (NEXThaler®) on central and peripheral     airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will be     used. Further more, the effect of this combination therapy on lung function (spirometry,     resistance and diffusion), the Asthma Control Test (ACT™) and the Asthma Control     Questionnaire (ACQ) will be assessed and the safety will be evaluated.   "
124932|NCT01650428|"     The purpose of this study is to evaluate the efficacy, toxicity and feasibility of FOLFOX/     bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as     defined by MRI.   "
124933|NCT01650415|"     This randomized placebo-controlled trial aims to investigate the efficacy and safety of     erythropoetin for children with cerebral palsy.   "
124934|NCT01650402|"     This study will evaluate different treatment strategies for high blood pressure using     medications approved by the US Food and Drug Administration (FDA) for the treatment of high     blood pressure. The study will compare the effects of an intensive reduction of 24-hour     average blood pressure to a standard reduction of 24-hour mean blood pressure on controlling     declines in mobility (speed and agility of walking) and cognition (ability to think and     process information) in an aging population.   "
124935|NCT01650389|"     Rationale: The Bacille Calmette-Guérin (BCG) vaccine protects children against disseminated     tuberculosis (TB) including TB meningitis and miliary TB, but efficacy against pulmonary TB     is inconsistent among children and adults. Administration of live attenuated BCG to infants     known to be HIV infected is contraindicated by the World Health Organization (WHO), due to     the risk of serious vaccine adverse events (BCG disease. Developing countries, which lack     capacity for integration of early infant HIV testing with infant vaccination schedules, have     not fully implemented the WHO guidelines on BCG vaccination of HIV exposed infants. Newborn     infants of HIV infected mothers continue to receive routine BCG before HIV infection has been     excluded.      Clinical trials of new viral-vectored TB vaccines, including MVA85A, a modified vaccinia     virus Ankara (MVA) vaccine expressing the Mycobacterium tuberculosis antigen 85A, have to     date enrolled infants who were already vaccinated with routine BCG at birth. However, TB     vaccination regimens that depend on newborn BCG will remain unsafe for HIV infected infants.     Infants of HIV infected mothers, who constituted 29% of babies born in South Africa in 2009,     would benefit from a new TB vaccination strategy, in which BCG is delayed until after HIV     infection has been excluded. These HIV exposed infants also have greater increased risk of TB     disease. Testing the safety and immunogenicity of MVA85A vaccine prime, followed by selective     delayed BCG boost, in HIV exposed newborns, is a critical step towards delivery of a new TB     vaccine regimen that is safe and effective for all infants, regardless of HIV exposure.      Study Design: Double blinded, randomised, controlled trial. HIV exposed infants will be     randomised 1:1 to receive single dose, intradermal MVA85A vaccine or Candin® control at     birth. The first 60 infants enrolled in the trial will form a pilot safety cohort for formal     Data Monitoring & Ethics Committee (DMEC) safety review. Thereafter, safety and     immunogenicity outcomes will be measured in all infants.      Study Population: Infants (n=340) born to HIV infected mothers receiving antiretroviral     therapy (ART) or Prevention of Mother to Child Transmission (PMTCT) prophylaxis.      Sites: Worcester (University of Cape Town) and Khayelitsha (Stellenbosch University), South     Africa      Study Intervention: Newborn infants will receive 1 x 108 pfu MVA85A vaccine or Candin®     control by intradermal injection. Infants confirmed HIV uninfected by HIV PCR will receive     BCG Vaccine SSI at 8 weeks of age. Infants confirmed HIV infected by HIV PCR will not receive     BCG.      Primary specific aims:      To evaluate the safety of MVA85A given at birth to HIV exposed uninfected infants.      To evaluate the safety of BCG given at 8 weeks of age to HIV exposed uninfected infants,     using an MVA85A prime and BCG boost strategy.      Secondary specific aims:      To evaluate the immunogenicity of MVA85A given at birth to HIV exposed uninfected infants.      To evaluate the immunogenicity of BCG given at 8 weeks of age to HIV exposed uninfected     infants, using an MVA85A prime and BCG boost strategy.      Safety endpoints:      Local, regional, and systemic adverse events (AEs) and serious adverse events (SAEs).      Immunology endpoints:      Frequencies of CD4 and CD8 T cells producing any of 4 cytokines (IL-17, IFN-γ, TNF-α, or     IL-2), or polyfunctional combinations of these cytokines simultaneously, following     stimulation with antigen Ag85A or BCG, measured by whole blood intracellular cytokine assay     (WB-ICS).      Specific proliferative capacity of CD8 and CD4 T cells that produce any of the three     cytokines (IFN-γ, TNF-α, and/or IL-2) or combinations of these cytokines simultaneously,     measured by a novel whole blood 6-day lymphoproliferative flow cytometric assay (WB-prolif).      Relative proportions and absolute numbers of peripheral blood myeloid and lymphoid cell     subsets, measured directly ex vivo by flow cytometry.      Study groups: The first 60 infants enrolled in Study Group 1 will undergo intensive safety     evaluation, followed by DMEC review of Day-28 safety data. The DMEC will make a formal     recommendation on continuation of enrollment and/or changes to the protocol, based on this     safety review. Study Groups 2-5 will be evaluated for clinical safety and immunology     outcomes.      Statistical Analysis: Cumulative 12-month incidence of local, regional, and systemic AEs, by     category, will be compared for HIV exposed uninfected subjects receiving MVA85A vaccine or     Candin® control at birth. The sample size has 90% probability of detecting an SAE with a true     occurrence rate of 1.5% in infants receiving MVA85A vaccine and 80% power to detect a 15%     difference in the rate of non-serious AEs (20% compared to 35%) between the two study arms     (p<0.05). Multivariate models will be built to explore longitudinal immunological data and     identify independent associations with MVA85A vaccination and covariates of interest.   "
124936|NCT01650376|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of the     investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in     patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators     intend to study the safety and tolerability of the study treatment, response to treatment,     time to disease progression, and overall survival.   "
124949|NCT01650207|"     Shoulder pain has been reported to be one of the most common complications after stroke.     Several factors have been related to shoulder pain after stroke such as paralysis, restricted     range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship     between these factors and pain was not discussed.      The aim of this study is to identify the efficacy of electroacupuncture in reducing upper     limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life     (QOL) for stroke patients.   "
124937|NCT01650363|"     This is a randomized controlled clinical trial in which the combination of 4 different CAM     modalities (Complementary & Alternative Medicine) will be applied during the postoperative     period to patients undergoing open heart- or lung surgery and expected to be hospitalized for     more than 5 days.      Elective and Urgent surgical patients will be randomly assigned to a treatment - and to a     control group. The treatment group will be treated with a combination of 4 different CAM     modalities (Homeopathy, Osteopathy, and Acupuncture & Reflexology) . The control group will     be treated with Homeopathic placebo medication.      The main Outcome measurement in the study will be the Quality of recovery 40 questionnaire     (QoR- 40) that will be filled out on postoperative days: 3, 5, and 7 respectively. Secondary     outcome measurements will be Blood &Saliva Cortisol levels, DHES levels in the blood as     surrogates of stress, IL-2 levels as measures of the immune system. Further parameters to be     measured include: LOS (length of stay), Level of Pain, mobility, level of satisfaction, GI     symptoms (nausea, first bowel movement), post-operative complications& side effects.      All patients participating in the trial will sign an informed consent form . The trial is     expected to be conducted over a period of 12 months. Prior to the trial a pilot study will be     conducted on a group of 30 patients in order to determine the needed sample size for the     trial.   "
124938|NCT01650350|"     will scientifically evaluate whether Low Dose Naltrexone (LDN) has activity in refractory     solid tumors within the context of a phase II clinical study   "
124939|NCT01650337|"     BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed.     In March 2012, experts estimated that 40,000 health related smartphone applications were on     the market but little is known about the effectiveness of these programs. To our knowledge,     no studies have evaluated whether weight loss can be successfully achieved through use of a     smartphone application or how these applications could be used in primary care practice.      PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight     loss and calorie counting in a primary care setting.      METHODS: The first phase of this study involved a community based participatory approach to     select the intervention. Patient focus groups were conducted and analyzed to explore     patients' preferences regarding various text-message versus smartphone programs. The second     phase of this study, described here, will be a randomized controlled trial with overweight     primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2)     usual care plus smartphone application, which includes instructing participants on how to use     the application and encouraging them to use the applications' reminders and social networking     features. The primary outcome of interest is weight change at 3 and 6 months. Two-sample     t-test or Wilcoxon rank sum test will be used to compare weight change between groups, as     appropriate. ANCOVA models will be used to examine weight change after adjusting for     covariates such as education, sex and age. Repeated measures analysis will be carried out to     compare weight change between the groups using baseline, 3 month and 6 month data. In     addition to an intent-to-treat analysis, the investigators will also conduct a treatment     received analysis, adjusting for the extent of application use in both the intervention and     control arms.      CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in     primary care settings and incorporated into the visit can produce weight loss. Study findings     could inform a national discourse on the value of smartphone applications in routine clinical     practice.   "
124940|NCT01650324|"     The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and     pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.   "
125514|NCT01642199|"     The primary aim of this study is to determine whether reduced intensity behavioral weight     loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than     rBWL + Mentor Health Coaches and rBWL alone.   "
124941|NCT01650311|"     Alterations in normal serotonin (5-hydroxytryptamine;5-HT) signaling have been reported in     ulcerative colitis (UC) and Crohn's disease (CD). Studies report an increase in     enterochromaffin (EC) cell, main source of 5-HT in the gut, numbers in CD and UC patients.     Up-regulated expression of mucosal Tryptophan hydroxylase (TPH)-1, catalytic enzyme in 5-HT     production, messenger RNA (mRNA) have been found in CD patients in remission who are     suffering the irritable bowel syndrome (IBS)-like symptoms. Alterations in normal 5-HT     signaling has also been reported in animal models of inflammatory bowel disease (IBD). Thus,     the aim of the proposed research project will be to study the alterations in 5-HT signalling     accompanying GI inflammatory conditions, such as IBD.   "
124942|NCT01650298|"     The purpose of this study is to determine whether it is safe to stop anticoagulation     medication in patients with a history of atrial fibrillation (AF) based on information from a     pacemaker or implantable cardioverter defibrillator (ICD).   "
124943|NCT01650285|"     There is a high relapse rate for patients who have undergone prostatectomy and have     pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle     involvement (pathologic stage 3 disease). While adjuvant radiation improves progression-free     and overall survival, approximately half of these patients will develop recurrence.     Similarly, radiation therapy has become the standard salvage therapy for patients with rising     PSA >0.1 - < 2.0 ng/mL. In common solid tumors such as NSCLC, head and neck cancer and upper     gastrointestinal cancers, the addition of chemotherapy to radiation improves survival. It is     hypothesized that the addition of radiosensitizing chemotherapy to standard adjuvant     radiation will improve survival in patients with stage 3 prostate cancer after prostatectomy     and patients with rising PSA < 2.0 ng.mL without detectable disease. Taxanes are powerful     radiation enhancers since they synchronize tumor cells in G2/M the most radiosensitive phase     of the cell cycle.17,18 Cabazitaxel is the most active taxane in the treatment of prostate     cancer. Therefore, we propose a phase I study establishing the optimal dose of cabazitaxel     with adjuvant radiation for stage 3 prostate cancer after prostatectomy (PSA undetectable - <     2.0 ng/mL). and for patients with persistent or rising PSA post prostatectomy (PSA >0.1 - <     2.0 ng/mL).   "
124944|NCT01650272|"     5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic     alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5%     Minoxidil in solution is the first choice preparation for treatment, therefore allergic     contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol     which is the main solvent of these solution, was the main responsible to allergic contact     dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the     alternative solution using butylene glycol as the solvent was invented to solve the problem.     In Siriraj hospital the investigators using this new solvent and made our in house product     called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have     not been investigated. This study is conducted to evaluated efficacy and safety of 5%     Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.   "
124945|NCT01650259|"     Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as     monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics     of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral     antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic     drug).   "
124946|NCT01650246|"     This study will assess the serum uric acid lowering effects and safety of lesinurad over a     long-term timeframe.   "
124950|NCT01650194|"     The purpose of this study is to explore the safety and tolerability of enzalutamide in     combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the     prostate that is getting worse and spread to the bone despite receiving hormone treatment     will be enrolled and receive study treatment until disease progression.   "
124951|NCT01650181|"     Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the     upcoming years, the economic burden of this disease will increase and will mean an important     problem for our health system due to obesity epidemic.      There are several treatments for non-alcoholic steatohepatitis; however, none of them have     overcome a healthy lifestyle including diet, exercise and some drugs related with insulin     metabolism.      There after, using hepatoprotective drugs and antioxidants have been recommended as an     eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis.     Being this approach not only an experimental item yet but also an unavoidable reality.      The purpose of this randomized controlled study is explore the effects of     siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with     fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic     parameters.   "
124952|NCT01650168|"     This study compares the risks of short- and long-term use of NOMAC-E2 (containing a fixed     dose of nomegestrol acetate and estradiol) compared with levonorgestrel-containing combined     oral contraceptives (COC-LNG) in a study population representative of the actual users of the     individual preparations.   "
124953|NCT01650155|"     To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following     intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection.     Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics     of BI 1005273.   "
124954|NCT01650142|"     Thanks to the investigators previous study the investigators demonstrated the influence of     modifying genes in the phenotypic expression of neurofibromatosis 1 (Hum Mol Genet. 2009; 18     (15) :2768-78). Indeed, analysis of the intra-and inter-family variability performed using     the investigators phenotype/genotype database demonstrated a strong genetic component for     most clinical features. The investigators results suggest the involvement of genetic factors,     not related to the NF1 gene, the modifiers. The objective of this project is to identify the     modifiers involved in the variability of clinical expression of NF1. The investigators will     focus in particular variants involved in the development and progression of neurofibromas.   "
124955|NCT01650129|"     This trial is conducted in Japan. The aim of this trial is to investigate the safety and     efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human     insulin (BHI) 50 in subjects with type 2 diabetes.   "
125536|NCT01641913|"     Do patient's with eosinophilic esophagitis have increased small intestinal permeability and     if this changes in response to topically administered esophageal steroids?   "
124962|NCT01650038|"     Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon.     Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early     adulthood and lead to life-long substantial morbidity. There is no medical treatment     available that meets the desired criteria of high efficacy versus low adverse effects. The     current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves     an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal     microbiota in a genetically predisposed individual. Systematic investigation into the effect     of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most     radical way to restore the presumably disturbed natural homeostasis in UC is to perform     faecal transplantation from a healthy donor. In this trial the potential beneficial effects     of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be     studied in a phase II randomised placebo controlled design.      Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks     (primary), as well as time to recurrence, intra individual changes in faecal samples and     mucosal biopsies. Follow up is 12 months.   "
124963|NCT01650025|"     Obesity in children has become a significant social problem considering that nowadays 4 to 5     % of all children are obese in the industrialized countries with increased incidence in     Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome     in 30% of the children and is considered as a state of chronic inflammation inducing the     production of pro-inflammatory cytokines which determine metabolic and endocrine alterations     on the organism. It has been observed that obesity is also linked to a change in the     intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of     Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the     metabolites may provide us with a characterization of the existing phenotypes and variations     in relation to the changes of the physiological state, in particular when supplemented or not     with a probiotic preparation.   "
124964|NCT01650012|"     Forty percent of patients that require dialysis for kidney failure die within three years     mostly due to heart disease. Heart failure and high blood pressure are common problems in     patients that require dialysis and are key causes of death due to heart disease. Eplerenone     is a drug that is very effective at improving heart failure and reducing blood pressure in     patients that do not require dialysis. There is currently no evidence to tell physicians     whether eplerenone would have similar benefits in patients that require dialysis. This     evidence can only be reliably generated by performing a large scale study. Before such a     study is undertaken, the investigators must determine whether eplerenone will be well     tolerated and safe in patients that require dialysis. The investigators will perform an     initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone     antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe     medication to use in a very large, global study that will show whether or not eplerenone     reduces important outcomes for patients like death from heart causes.   "
124965|NCT01649999|"     This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the     dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects     given ASP015K for 12 weeks.   "
124966|NCT01649986|"     Cardiovascular prevention include a class I indication to statins in addition to     non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk'     according to current scientific guidelines. In the real world, however, statin treatment is     often discontinued due to side effects.      In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom     only non-pharmacologic intervention and prevention strategies are currently prescribed.      Along with non-pharmacologic intervention and prevention strategies, newer approaches to     reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived     from foods with cholesterol lowering actions.      The primary objective of this study is twofold:      First, to prospectively compare in the real world clinical practice the efficacy and     tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic     intervention with a nutraceutical-based protocol in patients in whom statin treatment is not     tolerated or is not indicated.      Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a     nutraceutical-based protocol among European countries.   "
124967|NCT01649973|"     Laryngeal view of the patient and anesthesiologist's discomfort level during endotracheal     intubation in relation to the various heights of operating table has not been investigated.     The investigators hypothesis is higher table height will improve the laryngeal exposure.   "
124968|NCT01649960|"     The investigators will do the study in two phases. The first phase will be a pilot study on     up to 18 participants [patients 60 years or older with coronary artery disease (CAD)     undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)     or patients who are eligible to undergo and participate in cardiac rehabilitation (CR)]; up     to 6 participants each will be given oral daily rapamycin (0.5, 1, and 2mg) dose for the     duration of CR. Baseline and follow-up data will be collected for age-associated impairment     (AAI): frailty (primary endpoint) and quality of life (QOL),senescent-associated secretory     phenotype (SASP)and abdominal/thigh subcutaneous adipose biopsy for measurement of adipocyte     mitochondrial DNA copy number and to quantitate the number of senescent preadipocytes. Safety     of rapamycin will be assessed by periodic clinical follow-up, blood draws, and serum     rapamycin levels. Following completion of the pilot phase, the data will be analyzed. If     favorable changes are noted in the SASP or AAI, the investigators will start a phase 2     randomized trial.      Second phase: In a prospective, randomized, clinical trial design, patients 60 years or older     will be randomized at the time of CR to a standardized exercise protocol, or exercise     protocol with the addition of low-dose rapamycin to test the hypothesis whether low-dose     rapamycin (demonstrated in the pilot trial to improve SASP/AAI) will improve measures of AAI,     SASP, or findings on the fat biopsy as compared to exercise alone. The null hypotheses are     that there is no improvement with rapamycin in measures of AAI or SASP.   "
124980|NCT01649804|"     This extension study of WA19926 will assess the long-term safety and the efficacy of     RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis.     Participants who have completed the core study WA19926 are eligible to participate.     Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The     anticipated time on study drug is 104 weeks.   "
124969|NCT01649947|"     The purpose of this study is to examine the combination of one standard treatment for lung     cancer plus an additional drug, hydroxychloroquine. The standard treatment for lung cancer     being used includes 2 chemotherapy drugs, called paclitaxel and carboplatin. Some patients     who have a specific type of lung cancer can also receive another drug, a drug that targets     blood vessels, called bevacizumab (also known as avastin). Hydroxychloroquine is an FDA     approved drug for the treatment of malaria, rheumatoid arthritis and lupus erythematosis.   "
124970|NCT01649934|"     The purpose of the current pilot study will be to utilize implementation intentions to     increase patient compliance with appointment attendance. Participants in the current study     will be individuals referred for evaluation of their treatment needs. Experimental groups     will create a simple induction consisting of what/when/where statements (implementation     intentions) with the intention of increasing their rate of calling to schedule and     subsequently attend appointments associated with their care. It is anticipated that     participants who take an active role in their plan and utilize the implementation intention     procedures will be more likely to make and attend the appointments suggested by their     treating clinician. This pilot project will provide valuable initial data as to the potential     effectiveness of a simple, cost-effective means of increasing appointment attendance. If     successful, it could lead to cost savings and a decrease in the appointment wait time for     people by increasing the utilization of available appointments.   "
124971|NCT01649921|"     The primary aim of this study is to assess the effects of adjunctive therapy with Interferon     (IFN)-gamma on immune function in patients with septic shock in a placebo-controlled manner.     Moreover, the investigators want to evaluate new markers that could be used to identify     patients with immunoparalysis, and to monitor the patient's immunological response to IFN-γ.     In addition, mechanistic studies will be performed to further elucidate mechanisms (such as     epigenetic modifications) behind immunoparalysis and the effects of IFN-γ on these     mechanisms. With use of the results the investigators will obtain in this pilot study, the     investigators will conduct a large multicentre clinical trial with IFN-γ.   "
124972|NCT01649908|"     Different cross clamping techniques in aortic surgery causes different cardiac stress   "
124973|NCT01649895|"     The purpose of this study is to examine if D-Cycloserine is an effective adjunct to     internet-based cognitive behaviour therapy for patients with obsessive-compulsive disorder.   "
124974|NCT01649882|"     Correct positioning of the endotracheal tube (ETT) is crucial to ensure safe ventilation. To     date, no test that can verify this right after intubation at the bedside exists. Indirect     tests have false negative and positive results leading to complications or at least     difficulties in performing effective ventilation of patients.      Bedside ultrasound could fill this need. Although bedside ultrasound may not be possible or     useful in routine intubations, it may prove useful in difficult or questionable cases, where     current clinical exams/techniques may not offer a reliable indication of endotracheal tube     depth.   "
124975|NCT01649869|"     Valganciclovir is a mono-valyl ester pro-drug of ganciclovir, which is rapidly converted to     ganciclovir on absorption. Valganciclovir is approved for the treatment of Cytomegalovirus     (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), and for the     prevention of CMV disease in kidney, heart, and kidney-pancreas high-risk transplant     patients. The formulation used in this study will be valganciclovir oral solution which is     commercially available. It will be provided as a 12g powder containing 5g valganciclovir free     base. The oral solution formulation comprises the following excipients: Providone K30,     fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water. The     valganciclovir oral solution formulation does not contain lactose anhydrous.      The placebo comparator will be commercially available Simple Syrup (Syrup NF) as 60-90%     sucrose in purified water.   "
124976|NCT01649856|"     This multicenter, randomized, open label parallel-group study will evaluate the efficacy and     safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with     CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell     lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg     subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8     cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study     treatment is 6 months.   "
124977|NCT01649843|"     Achalasia is a rare esophageal motility disorder, which is characterized clinically by     symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are     primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal     sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus.     Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed     at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus     transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic     myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy     technique intending a permanent cure from primary achalasia in some centers. The     investigators purpose was to further evaluate the efficacy and the feasibility of POEM for     patients with achalasia in a prospective larger study.   "
124978|NCT01649830|"     Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative     nature and frequent growth in eloquent area in brain often makes total resection impossible.     Until now, no agreement has been achieved on the treatment of LGG without total resection.     Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade     gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas.     However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to     be defined. In this randomized controlled trial, the investigators will test the hypothesis     that radiotherapy with subsequent TMZ chemotherapy is superior to improve the     progression-free survival of patients with residue LGG without significant impairment to     quality of life compared to radiotherapy alone.   "
124979|NCT01649817|"     This multicenter, retrospective observational study will evaluate compliance an reasons for     withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with     intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be     collected from each eligible patient over a period of 6 months.   "
124990|NCT01649674|"     The purpose of this study is to to compare two bowel preparation regimens of patients who     will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient     satisfaction.   "
124981|NCT01649791|"     This clinical trial studies lenalidomide as chemoprevention in treating patients with     high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the     use of certain drugs to keep cancer from forming. The use of lenalidomide may slow disease     progression in patients with early stage B-cell chronic lymphocytic leukemia   "
124982|NCT01649778|"     This is a global, multi-centre, long-term, prospective, observational study to evaluate     treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated     for the first time with pazopanib. The study is designed to enroll approximately 700-1000     patients in over the course of an enrollment period of approximately 18 months.There are no     protocol-mandated visits or procedures associated with the study. Each patient is expected to     participate for a maximum of 30 months or until premature discontinuation (i.e., due to     death, withdrawal of consent, lost to follow-up or study termination).   "
124983|NCT01649765|"     This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of     belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic     lupus erythematosus   "
124995|NCT01649609|"     BK virus infections after kidney transplant are increasing and can result in damage to the     transplanted kidney. Currently, the universally accepted treatment is to decrease the     strength of the antirejection medications but it is unclear what medications should be     lowered and to what extent. The investigators propose to perform a study with patients who     have BK virus detected in their blood during routine screening that appears to be increasing.     The investigators will use two different strategies that involve different combinations of     standard anti-rejection medications at lower dosages. Patients will be assigned to one of the     two groups in a random manner across the two hospitals participating in the study. Patients     will be followed for at least a year to determine if one strategy was more effective than the     other in preventing an increase in the number of viruses in the blood stream and whether     either one was more effective in reducing the negative impact of the infection on the     functioning of the transplanted kidney.   "
124984|NCT01649752|"     Background:      Improving implantation rates in ICSI cycles has been the focus of research in recent decades.     Because success rates is not satisfactory enough especially when transferring good embryos to     the uterine cavity and pregnancy does not occur. Trying to improve endometrial receptivity,     the investigators have thought about stem cell therapy as stem cells have played a pivotal     role in regenerative medicine in many pathologies as myocardial infarction, Diabetes Mellitus     and spinal cord injuries.      Garget and Healy reported in 2011 treatment of a case with Asherman's syndrome by     administration of bone marrow stem cells in the uterine cavity. Endometrial growth and     improved vascularity has been observed by ultrasound follow-up and Doppler study of     endometrial blood flow. Endometrial regeneration has been enough to support pregnancy through     successful IVF trial.      The investigators have succeeded in previous work to isolate MSC from placental tissue and     differentiate it to endometrium-like cells. The investigators compared the differentiation     ability of placental derived mesenchymal stem cells (MSC) and Wharton Jelly derived MSC to     differentiate to endometrium under 3 different culture conditions: endometrium conditioned     medium (ECM), follicular fluid (FF) conditioned medium and medium containing both. The     investigators found that placental MSC has better differentiating ability to endometrium     especially under culture conditions containing both ECM and FF as evidenced by prominent     appearance of glandular pattern and expression of progesterone receptors in differentiated     cells.      Therefore the investigators need to direct this study and test the effect of placental     derived MSC in improving implantation rates in patients with recurrent implantation failure,     unresponsive endometrium to ovulation induction drugs or with endometrial atrophy or advanced     maternal age planning for ICSI trial.      Patients and Methods:      60 patients attending Kasr El-Aini assisted reproduction unit and private IVF center will be     randomized to three groups by computer generated programs:      The first group, patients randomized to receive differentiated stem cell therapy:      After ovum pick-up, MSC differentiated to endometrium is deposited in the uterine cavity     through an IUI catheter. Embryo transfer will be done at day 5 at the blastocyst stage to     allow enough time for endometrial regeneration and increased endometrial receptivity.      The second group, patients randomized to receive undifferentiated stem cell therapy:      Immediately postmenstrual undifferentiated MSC is deposited in the uterine cavity through an     IUI catheter to allow enough time for the MSC to differentiate as it needs 7-10 days for     differentiation. Ovum pick-up will be done as usual while all other steps will be the same     including embryo transfer which will be done at day 5.      The third group, control group:      Patients are randomized to receive no stem cell therapy; All ICSI steps from ovulation     induction protocol to embryo transfer conditions will be the same for all groups.      Informed consent will be taken from the patients after detailed explanation of all steps of     the procedure.   "
124985|NCT01649739|"     Patients with pulmonary arterial hypertension (PAH) suffer from breathlessness, poor quality     of life and inability to function, despite medical therapy Current consensus states that     combination therapy with different classes of PAH-specific therapy is likely to bring     additional benefit to PAH patients. In this study we plan to study how exercise performance     changes when the phosphodiesterase inhibitor vardenafil is added to patients who remain     symptomatic from PAH when treated with inhaled iloprost.      Following baseline assessment, all Patients will start vardenafil 10 mg bid. If the drug is     tolerated by the patients, after a two week period, up titration to 20 mg bid will be     permitted, at the discretion of the investigators.      According to treatment protocol up titration will be done carefully and whenever side effects     will be reported up titration will be stopped or dosage will be decreased or stopped     according to the investigator judgment.      Systemic BP will be measured at baseline assessment. The patient will attend the clinic for     the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg.      Systemic BP will be measured at baseline assessment. The patient will attend the clinic for     the first dose monitoring (10 mg) and after up titration of the study drug to 20 mg. A fall     in SBP of>30 mmHg will be considered significant or any smaller value at the discretion of     the investigator. BP will be measured according to the following protocol.      Pre-dose Immediately before administration of vardenafil. This will be timed approximately     one hour prior to the next planned dose of iloprost.      Pre-inhalation One hour post vardenafil dose, immediately prior to iloprost inhalation.      Post-inhalation Immediately following completion of iloprost inhalation and every fifteen     minutes for one hour.      Prior to discharge Two hours following the iloprost.      Later monitoring At all follow-up visits, BP will be measured.      This is an open-label study to evaluate the safety and efficacy of adding higher doses of     vardenafil to inhaled iloprost over 3 months.   "
124986|NCT01649726|"     Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem     reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous     breathing is established the apnea test (according to the American Academy of Neurology's     Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and     cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some     data suggest modifying the apnea test : replace the ventilator switching off with continuous     positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP)     increased the level of lung harvest but they were not sufficient because these studies were     monocentric, non randomized and with little patients,. That why the aim of the present study     is to compare the standard strategy and CPAP strategy with a prospective, multicenter,     randomized study.   "
124987|NCT01649713|"     This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for     injection (trivalent, seasonal influenza vaccine, active ingredient content: 15     μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single     intramuscular injection of Fluval AB suspension for injection, as measured by     haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of     adverse events) of a single intramuscular injection of Fluval AB suspension for injection.   "
124988|NCT01649700|"     The study is to investigate the efficacy and safety of autologous transplantation of     adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain     injury.   "
124989|NCT01649687|"     The study is to investigate the efficacy and safety of allogenous transplantation of     adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.   "
124991|NCT01649661|"     The purpose of this study is to learn about how a woman's health history influences what a     normal breast looks like on an MRI. The investigators also want to learn about how the amount     of different natural hormones a woman has affects how the breast looks on an MRI. The     investigator's hope is that this will help to find women at a high-risk of breast cancer.   "
124992|NCT01649648|"     This is a pilot study to test feasibility and safety of collection, preparation and infusion     of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby     is born with signs of brain injury. The cord blood used is fresh (not frozen and then     thawed).   "
124993|NCT01649635|"     Primary Objective:      - To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3     neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.      Secondary Objectives:        -  PSA response rate;        -  Descriptive assessment of CTC (circulating Tumor Cells);        -  Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the          treatment period;        -  Description of the Health Quality of Life of the patients;        -  Incidence of adverse events.   "
124994|NCT01649622|"     The goal of this clinical research study is to learn if bendamustine can help to control     Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied.      Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them     to die.   "
125011|NCT01649388|"     This study involves the use of an enriched hematopoetic stem cell infusion (stem cells,     produced by the bone marrow) from the same donor who provided the original kidney transplant.     This kidney transplant may have taken place months to years previously.   "
124996|NCT01649596|"     The purpose of this proposed study is to evaluate a normothermia protocol that includes     preoperative warming and standard intra operative temperature management in patients     undergoing general surgery.      The study aim is to compare short term outcomes in patients for whom warming is expanded by     commencing in the pre operative area and is maintained through post operative recovery versus     patients receiving the standard warming at time of induction.      The overall study goal is to test for differences in the rate of hypothermic events between     the two groups.      A secondary goal is to test for differences in the complication rate and patient satisfaction     between the two groups.      This study is testing the hypothesis that expanded warming significantly reduces rates of     hypothermia and complications over standard warming used only during surgery.   "
124997|NCT01649583|"     The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can     be used during and immediately after cancer treatment. The Dynasplint® is a stretching device     that is used to treat joint stiffness and limited range of motion in the jaw. The device is     currently approved for treatment of trismus once it has developed. This study will     investigate the use of the device during and immediately after cancer treatment to prevent     trismus.   "
124998|NCT01649570|"     This trial is conducted in Japan. The aim of this trial is to investigate the safety and     efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes     treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.   "
124999|NCT01649557|"     This will be a multicenter, 52 week, open label study to assess the safety and tolerability     of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study     will be conducted on an outpatient basis. Enrollment into the study will be drawn from     eligible subjects who have completed participation in Study 331-07- 203 and who, in the     investigator's judgment, would benefit from continued treatment with oral OPC-34712.   "
125000|NCT01649544|"     In pre-operative cardiac surgery, 30 to 40% of patients with mitral valvulopathy have had     episodes of paroxysmal atrial fibrillation (PAF) or are in permanent or chronic atrial     fibrillation (CAF). According to the 1999 PMSI data, close to 4000 mitral valve interventions     were performed in France, in other words, more than 1000 patients present with this condition     annually; despite a surgical correction of their valvulopathy, patients presenting with a     pre-operative chronic atrial fibrillation remain in fibrillation following surgery despite     treatment with anti-arrhythmic agents associated or not with a cardioversion. Thus, the     survival rate without AF recurrence is 10% at 1 year and 5% at 2 years in patients with AF     prior to surgery; on the other hand, patients in sinus rhythm at the time of surgery and     without an antecedent of AF exhibit an incidence of no AF of 90% and 74% at 1 and 2 years,     respectively. It has also been shown in numerous studies that the long-term morbidity in     patients with atrial valve surgery is higher in those with AF.      For more than 10 years, radio-frequency techniques using the endocavitary approach have shown     a greater efficacy in maintaining sinus rhythm than drug therapy even though the techniques     are invasive. These radio-frequency techniques were developed and tested during mitral     surgery, but, to the investigators knowledge, there is only one randomized study that was     carried out in a population with permanent AF using radio-frequency technique via the     endocardial approach. Maintenance of sinus rhythm was obtained in only 44.4% of patients     versus 4.5% in the control group; these results are not in accordance with the published     prospective and retrospective registries using the technique peri-operatively. The principal     problem of this study is the absence of medical treatment in the control group. In addition,     the use of the radio-frequency technique requires an atriotomy resulting in a prolonged     surgical time, which increases the peri-operative morbidity.      Other simpler ablation techniques have been developed, such as the one using ultrasound. In     comparison with the radio-frequency method, this latter technique presents numerous     advantages including the absence of an atriotomy due to the fact that the epicardial pathway     is used, a short procedure time (11 min on average), excellent reproducibility, the     transmural character of the lesions, along with the simplicity of application. There is not,     to the investigators knowledge, a randomized study comparing the peri-operative ultrasound     technique (EPICOR) in mitral valve surgery with the conservative reference treatment, notably     mitral valve surgery coupled with long-term amiodarone treatment. In effect, while amiodarone     is the most efficacious anti-arrhythmic agent in the long-term, this drug is associated with     a high percentage of significant side effects, close to 20% at 2 years. The only available     results using the ultrasound technique are the registries pertaining to the follow-up of     patients undergoing cardiac mitral or aortic surgery, with an antecedent of AF. The results     appear to be encouraging with 85% of cases maintained in sinus rhythm at 12 months in the     most recent studies. In this clinical context, a French multi-centric registry evaluated the     peri-operative treatment of AF with all of the proposed techniques (cryotherapy,     radio-frequency, and ultrasound). The percentage of maintenance of sinus rhythm appears to be     lower than in the historical registries, at the level of 60%, but the techniques used in this     registry were multiple even if 50% of patients were treated with ultrasound; in addition,     there was no randomization and follow-up was only for 6 months.   "
125001|NCT01649531|"     The aim of the present study is to test whether there is a difference in the marginal bone     level change between implants with and without cantilevers.   "
125002|NCT01649518|"     Osteoarthritis is the most common affection of joints worldwide. Multiple international     guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless     there seems to be a gap between usual care and the preferred one.      A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy     was developed by a multidisciplinary expert team. This project aims to map usual care and to     explore the gaps between usual care and international guidelines in a second stage. This will     enable us to develop a tightly targeted quality improvement intervention later on.   "
125003|NCT01649505|"     The purpose of this study is to investigate the efficacy of an alternative surgical technique     and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a     build-up of clear bodily fluids in a place on the body where tissue has been removed by     surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days     after surgery, after the drainage tubes have been removed. The breast area involved in the     surgery may have a spot that's swollen and feels like there is liquid under the skin   "
125004|NCT01649492|"     The goal of this study is to evaluate the actual potential for in vivo pineapple juice     inhibition with CYP2C9 substrates in human volunteers with use of diclofenac as a marker of     CYP2C9 activity.   "
125005|NCT01649479|"     The main objective of this study is to estimate the lifetime prevalence of major psychiatric     disorders (axis I DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, version IV)     in a large sample of patients with developed clinical signs of pure obstetrical     antiphospholipid syndrome (suspected APS).   "
125006|NCT01649466|"     This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin     add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate     glycemic control on their current sulfonylurea monotherapy to give treating physicians a     guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is     not sufficient to reach glycemic control.   "
125007|NCT01649453|"     The study prospectively assesses the change in cancer-specific clinical decisions and     outcomes before and after physicians received results from the Pathwork® Tissue of Origin     (TOO) Test for patients whose primary site of cancer origin is uncertain.   "
125075|NCT01648608|"     Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy     and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant     chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the     same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of     TAC and Exemestane.   "
125008|NCT01649440|"     The occurrence of sepsis and its relevant multiple organ dysfunction remain a major problem     in intensive care units with high morbidity and mortality. The differentiation between     non-infectious and infectious etiologies, severity and organ function evaluation, and     prognostic assessment are all challenging in routine clinical practice. Many biomarkers have     been suggested for these purpose; however sensitivity and specificity even of high-ranking     biomarkers still remain insufficient. Recently, metabolic profiling has attracted interest     for biomarker discovery. In this study, LC-MS/MS will be perform to identify serum metabolic     biomarkers for differentiation of SIRS/sepsis, severity and organ function evaluation, and     prognostic assessment among 65 patients. The investigators enrolled 35 patients who were     diagnosed with sepsis, 15 patients who were diagnosed with SIRS, and 15 normal patients.     Moreover, the sepsis were further divided into sepsis, severe sepsis, and sepsis patients     before death. Small metabolites that were present in patient serum samples were measured by     LC-MS/MS techniques and analyzed using multivariate statistical methods, such as Principal     Component Analysis (PCA), Partial Least Squares-Discriminant Analysis (PLS-DA), and     Orthogonal Partial Least Squares Discriminant Analysis. Based on the multivariate statistical     analysis above, the investigators could distinguish sepsis from normal and SIRS; distinguish     the difference among sepsis, severe sepsis and death. We hypothesis that some metabolites as     identified in this study are promising biomarker candidates in the field of sepsis diagnosis     and treatment.   "
125009|NCT01649427|"     The purpose of this study is to investigate if Tacrolimus Hexal® has similar pharmacokinetic     properties compared to Prograf® in de novo renal transplant patients and whether the     comparable exposure results in similar renal function.   "
125010|NCT01649401|"     The main objective of this study is to determine whether the use of the PARI LC Sprint Sp     nebulizer in the treatment of asthma in children under 36 months reduces the duration of     hospitalization.   "
125015|NCT01649336|"     This is a Phase 1 study during which patients with platinum-resistant epithelial ovarian,     fallopian tube or primary peritoneal cancer will receive investigational study drug MEK162     and paclitaxel. Patients will receive increasing doses of study drug in combination with     paclitaxel in order to achieve the highest dose of study drug possible that will not cause     unacceptable side effects. Patients will be followed to see what side effects the combination     causes and what effectiveness the combination has, if any, in treating the cancer.     Approximately 36 patients from the US will be enrolled in this study.   "
125016|NCT01649310|"     The whole body vibration offers better treatment adherence among the elderly, minimizing     effort and additional stress to the cardiovascular system and skeletal muscles compared to     conventional exercise programs.      Hypothesis: Patients with COPD undergoing a training program on the whole body vibration show     better performance in the 6MWT and improvement in muscle strength.   "
125017|NCT01649297|"     The aim of this study is to investigate the efficacy and safety of two doses (high and low)     of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus     (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a     twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose     once daily or split vs. low dose once daily or split). This is done to evaluate whether a     twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once     daily dosing when given on top of metformin background therapy.   "
125018|NCT01649284|"     This is an open-label, multi-center, single-arm trial, designed to provide early access to     afatinib and to provide additional information on the safety and efficacy of afatinib in     advanced NSCLC patients who harbor an EGFR mutation.   "
125019|NCT01649271|"     The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in     combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the     efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2     overexpressing metastatic breast cancer.   "
125020|NCT01649258|"     This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal     system work in preventing nausea and vomiting in patients with breast cancer undergoing     chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients     treated with chemotherapy   "
125021|NCT01649245|"     It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant     interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in     treatment of Egyptian patients with chronic hepatitis C for 48 weeks.      hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of     treatment, as well as 24 weeks after therapy is completed.   "
125022|NCT01649232|"     In the present study the aim is to examine whether transcranial direct-current stimulation     (tDCS) generated excitability changes and induce modifications of functional cortical     architecture in Attention Deficit Hyperactivity Disorder (ADHD) patients. To achieve this,     the investigators used an event-related potential (ERP) analysis based on 20 channel EEG     recordings in ADHD subjects before and after bipolar tDCS-anode stimulation over F3/F4 or     T5/T6 or P4/P3, during resting state and measure clinical scores and visual CPT tasks     changes. Time courses and topography of independent component visual ERPs were compared     before and after tDCS.   "
125023|NCT01649219|"     Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and     2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom     impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.   "
125024|NCT01649206|"     Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the     management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for     patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of     subjects with TNs (one group to treat with RTA and a matched untreated control group) will be     evaluated in term of TN volume, thyroid hormones and clinical symptoms.   "
125076|NCT01648595|"     Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain     of delivery. It is necessary to be known effect of these drugs on the mother and fetus during     labor adverse. Therefore, the purpose of this study was determination of effect of Fentanyl     intravenously on pain severity during the active phase of labor.   "
126931|NCT01623648|"     The investigators hypothesis is that eating whey protein in the breakfast versus other     proteins will results in higher satiety, reduced overall postprandial glycemia and more     weight loss in obese diabetic individuals   "
125025|NCT01649193|"     The purpose of this study is to determine the important change in the Short Physical     Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple     physical test that measures balance and the functioning of the legs. It has been widely used     in healthy elderly populations and predicts hospital admission and the onset of disability.     The SPPB has not previously been used in patients with lung disease, and it is not clear what     change in this test is considered meaningful and worthwhile by patients or doctors (the     minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow     researchers and doctors to evaluate the effectiveness of current and new treatments, and to     detect improvement or deterioration in the condition of patients.   "
125026|NCT01649180|"     The purpose of this study is to see how well the study drug, axitinib, helps control renal     (kidney) cancer that has come back (recurrent) or spread (metastatic). Patients must have     already been treated as a participant in a clinical trial with sunitinib, sorafenib,     pazopanib or placebo (sugar pill) after their initial surgery.      This study will examine the effect of adjuvant tyrosine kinase inhibition (TKI) therapy     (sorafenib, sunitinib or pazopanib) on subsequent exposure to TKI with axitinib in the     first-line recurrent or metastatic setting.   "
125027|NCT01649167|"     Background: Obesity in pregnancy is increasing and is a risk factor for metabolic pathology     such as preeclampsia. Leptin is an adipokine which has a direct relationship to obesity.      Aim: to measure leptin in lean, obese and diabetic pregnant women at three months intervals     throughout their pregnancies.      Methods: Pregnant women were recruited in the 1st trimester of pregnancy, and three groups     were formed: a) with pregestational Body Mass Index (BMI) less than 25 kg/m2, b) BMI higher     than 25 kg/m2 and c) with Gestational Diabetes Mellitus (GDM). Serum levels of leptin were     measured with radioimmunoassay (RIA) technique.   "
125028|NCT01649154|"     The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery.     The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative     blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of     post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to     traditional dissection in a prospective randomized trial of total thyroidectomy procedures,     for benign disease.   "
125029|NCT01649141|"     This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive     Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the     treatment of child sexual abuse, can be effectively transported to a state-contracted     community mental health agency in the state of Delaware and used effectively by clinicians     with little prior TF-CBT experience. The sample is comprised of youths receiving public     mental health services and with diverse trauma histories.   "
125030|NCT01649128|"     For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators     established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of     Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down     syndrome screening.   "
125031|NCT01649115|"     The purpose of this study is to evaluate the effectiveness of the Healthy Lifestyles Passport     Program (HLPP) in preventing infant and childhood obesity. It is hypothesized that the     participants in the intervention arm will exhibit less excessive weight-for-length gain from     4- to 6-months of age. In 2-years and 5-years, it is predicted that the participants in the     intervention arm will yield lower Body Mass Index (BMI) z-scores than the participants in the     control arm, who receive usual care.   "
125032|NCT01649102|"     The trial aims to compare the performance of two tunneled cuffed catheters (TCC) in chronic     hemodialysis patients. The design of the catheter may affect the propensity for thrombosis     and hence intraluminal infection, as well the percentage of recirculation and hence the     efficiency of dialysis.   "
125033|NCT01649089|"     This clinical trial studies the physical function and quality-of-life before and after     surgery in patients with stage I cervical cancer. Studying quality-of-life in patients     undergoing surgery for cervical cancer may help determine the intermediate-term and long-term     effects of surgery.   "
125034|NCT01649063|"     Dystocia is the most common indication for primary cesarean section. The most common cause of     dystocia is uterine dysfunction. In all cephalopelvic disproportion studies, more attention     is usually paid on fetus and pelvic rather than on the role of uterine contraction in     delivery. So we decided to determine the relationship between dystocia and uterine     contraction patterns.   "
125035|NCT01649050|"     To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due     to multiple sclerosis   "
125036|NCT01649037|"     All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or     during hospitalization will be included in the study.      The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory     tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver     histology, when available.   "
125037|NCT01649024|"     The study is designed to define the immunologic and clinical activity of Tremelimumab in     patients with advanced mesothelioma.   "
125038|NCT01649011|"     The purpose of the study is to validate in Mexico a spanish translation of the 2.1a Oswestry     Disability Index (ODI) version in patients with low back pain.      Internal consistency, reproducibility and reliability will be addressed scoring the results     of the translated version at two time frames. A previously spanish validated translation of     the of the Roland Morris Disability Questionnaire (RMDQ) will be used to compare and evaluate     both versions.   "
125077|NCT01648582|"     The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe     compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who     have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM)     (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended     by their healthcare providers.   "
125258|NCT01645761|"     Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a     reduction in mucus viscosity. As part of the search for more effective forms of therapy     against H. pylori when it colonizes not only the surface of the surface mucosal cells but     also the surface mucous gel layer covering the mucosal surface of the stomach. The     investigators decided to investigate whether or not endonase might have additive effect of     pronase on the efficacy of eradication therapy against Helicobacter pylori.   "
125039|NCT01648998|"     Stimulating the mineralocorticoid receptor (MR) may restore a disturbed balance as seen in     depression. In this double-blind, randomized, placebo-controlled trial the investigators will     test the effects of a single dose (500mg) fludrocortisone, an MR-agonist, on the information     processing in healthy female volunteers (N = 2x20).      The investigators want to investigate whether the acute administration of fludrocortisone     (FC) in healthy females enhances the appraisal of emotional information related to     depression, hypothesizing that:        -  FC relative to placebo selectively improves the recognition of happy and fearful faces:          resulting in more correct responses and faster RTs.        -  FC induces a bias towards more positive self-description and an improved memory for          positive information.      Female participants were selected because the haplotype MRI180V is related to depression     vulnerability in women, not in men. If the effects of fludrocortisone are comparable to the     effects of antidepressants on the same tests and the same population, it might be a first     indication that fludrocortisone may function as an antidepressant.   "
125040|NCT01648985|"     In acute stroke patients about 20 % have known diabetes. There is a doubled risk of recurrent     stroke in diabetic patients. It has been shown that antiplatelet drugs are not as effective     in diabetic patients as in non-diabetic patients. In acute stroke patients around 80 % have     impaired glucose tolerance, which will improve after one month till about 60 %.      This study includes acute patients with minor stroke or TIA. They are followed up at one and     six months and then at every six months for at least four years. The investigators perform an     OGTT and haemostatic tests within the first days after onset and then at one month. Blood     pressure, metabolic parameters, bodyweight, physical activity and diet are collected at each     visit. The investigators give the patients information about lifestyle changes as needed.      As part of the study there is an interventional study, Medicine Yoga, an open randomized     controlled study. Patients are randomized to 16 sessions of Yoga under professional     instructions and a CD for home training or controls.      The aims of this study are to investigate glucose tolerance in acute stroke and TIA patients,     and its relation to the different haemostatic variables. The importance of glucose tolerance,     haemostatic variables and other risk factors (blood pressure, lipids, BMI,) on cardiovascular     events will be investigated and the possibility to affect these risk factors by lifestyle     changes and Yoga. The effect of different antiplatelet drugs will be investigated in relation     to glucose tolerance.   "
125041|NCT01648972|"     After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this     time patients are often unable to eat and drink, and do not pass any flatus or stool. Though     this resolves within a few days for most, there are a significant number (around 30%) who go     on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It     has been clearly shown that this group of patients have worse health outcomes and spend a     longer time in hospital.      The aim of this study is to trial a drug - gastrografin - in the management of prolonged     postoperative ileus. Gastrografin is safe, economical, readily available, and has been used     with great success in the similar condition of bowel obstruction. It is predicted that     gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording     affected patients a better outcome from surgery.   "
125043|NCT01648946|"     Blood transfusion in critical ill patients has been associated to several complications and     worse outcome. Particularly in oncologic patients, red blood cell transfusion has been     investigated as a factor of worse outcome and cancer recurrence due impairment of cellular     immunity. Although red blood cell transfusion has decreased in worldwide clinical practice,     this issue still remains a matter of controversy in oncologic patients. There are no     prospective studies comparing outcomes between restrictive or liberal blood transfusion     strategy in oncologic critical patients. This study is a prospective and randomized study     comparing clinical outcomes between two strategies of transfusion in oncologic critical     patients - liberal or restrictive.   "
125044|NCT01648933|"     The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac     sarcoidosis.   "
125045|NCT01648920|"     Objective: To explore the utility of Fractional Exhaled Nitric Oxide (FeNO) compared with     Methacholine Challenge (MCC) testing in assessing patients with suspected but undiagnosed     asthma      Number of participants: Approximately 50 subjects will be enrolled      Reference product: NIOX MINO® Instrument (09-1100)      Performance assessments: FeNO measurements will be performed according to the Perform FeNO     Measurement guidelines on page 7 of the NIOX MINO® User Manual. MCC testing will be     performed according to the ATS guidelines and the allergy and asthma specialists procedure     for conducting MCC tests      Safety assessments: The Investigator is responsible for the detection, reporting, and     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious     Injuries as provided in this clinical investigation plan from the time that informed consent     has been provided and during the study period      Criteria for evaluations: This is an exploratory study and there are currently no plans for a     formal statistical analysis. Information gained from this study may used to design and power     subsequent studies in patients with suspected but undiagnosed asthma. Information collected     will be summarized in a clinical study report   "
125046|NCT01648907|"     This study is a large national multicenter, longitudinal, prospective follow-up of patients     presenting with early inflammatory back pain in order to set up a database to facilitate     several investigations on diagnosis, prognosis, epidemiology, pathogenesis and     medico-economics in the field of early inflammatory back pain and spondyloarthritis   "
125047|NCT01648894|"     At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to     planify the surgery. During this visit, the study will be explained them and their consent     obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients     were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in     this study does not change treatment, investigations and consultations usually necessary for     management of rectal cancer. The objective is to improve the pathological complete response     rate of the rectal cancer.   "
125048|NCT01648881|"     Patients with dissection of the descending aorta will be followed up according to a precise     timeline.   "
125049|NCT01648868|"     In this protocol we aim to use rTMS to better characterize STS role in normal and abnormal     social cognition. With that purpose, we will measure the effect of inhibitory and excitatory     rTMS on the fixation time on social scenes (using eye-tracking methodology) or on the ability     to recognize human voice/sounds.   "
125050|NCT01648855|"     Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and     neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and     antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of     preeclampsia. Patients with preeclampsia have a higher circulating concentration of     antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR-     1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and     a lower maternal circulating concentration of free angiogenic factors (ie, vascular     endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a     normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm     birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent     studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in     the number of small arteries and on abnormal distribution of vessels within the distal lungs.     This is associated with reduced lung VEGF expression. The main objective of this     population-based study, ie in intra uterine growth restricted preterm babies born before 30     weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and     umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD.   "
125051|NCT01648842|"     Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant     women who will develop preeclampsia in the second or third trimester compare to a control     group Primary purpose : To determine the vitamin D status in the first trimester in a large     population of french pregnant women in order to evaluate the importance of the vitamin D     deficiency in France and correlate this deficiency with preeclampsia   "
125052|NCT01648829|"     Levels of platelet reactivity in patients on Dual Antiplatelet Therapy (DAPT) can be     influenced by concomitant treatment with medications (i.e. statins) that inhibit the CYP3A4     system involved in the activation of clopidogrel. Atorvastatin and simvastatin are     metabolized by CYP3A4. Pitavastatin, unlike other statins, is little metabolized, most of the     dose being excreted unchanged in bile, and biotransformation through the cytochrome P450     system is minimal. Indeed, pitavastatin's cyclopropyl group diverts the drug away from     metabolism by CYP3A4 and allows only a small amount of clinically insignificant metabolism by     CYP2C9.      The primary objective of this study is to compare the pharmacodynamic effects of a     CYP3A4-metabolized statin (atorvastatin) versus a non-CYP3A4-metabolized statin     (pitavastatin) in patients showing high platelet reactivity while on DAPT.   "
125053|NCT01648816|"     The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a     higher maternal morbidity and mortality, and also with pervasive effects on the emotional,     cognitive and behavioral development of the infant.      Stressful life events, socio-demographic and obstetrical risk factors have been associated     with the risk of PPD. Genetics risk factors of PPD have also been identified. We are     presently studying for the first time how maternal stressors may interact with genetic     factors to increase the risk of PPD (Gene x Environment interaction).   "
125206|NCT01646450|"     A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as     first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC     and mutated EGFR.   "
125054|NCT01648803|"     The purpose of this study is to measure motor fluctuations and dyskinesias in patients with     Parkinson's disease using movement sensors (accelerometers and gyroscopes) to determine if     this is a feasible measure to use in addition to self report, and eventually the goal will be     to replace self report with a more reliable measure such as movement sensors.   "
125055|NCT01648790|"     The purpose of this study is to evaluate the amount of drug available in the body when given     to healthy participants as two different formulations with or without a meal. In addition,     this study will evaluate how much of the drug gets into the blood stream and how long the     body takes to get rid of it. Information about any side effects that may occur will also be     collected. Each participant will receive a total of five different treatments. Each treatment     is given by mouth, once a day. The treatment period lasts for five consecutive days.   "
125056|NCT01648777|"     Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase     their mortality. While chest physical therapy plays a crucial role to prevent postoperative     pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical     therapy. The continuous local anesthetic infusion by multiperforated catheter decreases     sternum pain. Because of this optimal pain management, early chest physical therapy could be     more efficient and could contribute to decrease the rate of pneumonia.      The aim of this study is to test if management of sternotomy pain using continuous local     anesthetic infusion by multiperforated catheter may contribute to decrease the rate of     perioperative pneumonia.   "
125057|NCT01648764|"     The purpose of this study is to evaluate two different dosing regimens of LY2334737 in     participants with cancer that is advanced and/or has spread to other parts of the body.     Information about side effects will be collected.   "
125058|NCT01648751|"     This is a randomized controlled trial in which women with symptomatic mild pelvic organ     prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus     placebo to see if a combined approach to treatment leads to improvement in clinical outcomes.     The investigators predict that PFPT in combination with vaginal estrogen will lead to     decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker     data.   "
125059|NCT01648738|"     The purpose of this study is to determine whether an intensive 5 days long multidisciplinary     program (including spa therapy, exercises and patients'education) is more effective regarding     return to work than usual care in subacute and chronic low back pain for people in sick leave     from 4 to 24 weeks duration, and for which an extension of sick leave is considered   "
125060|NCT01648725|"     Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what     extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.      A particular aspect of this study is that induction is provided by a closed-loop system which     delivers propofol according to bispectral index.   "
125143|NCT01647633|"     Over 20 million Americans have allergic nasal symptoms including stuffiness, sneezing and a     runny nose. AkPharma's Calcium Glycerophosphate used as a nasal spray wash is believed to     improve these symptoms without side effects common to over the counter and prescription     medication. It is hypothesized that Calcium Glycerophosphate will have a perceived     improvement in breathing comfort.   "
125061|NCT01648712|"     Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system     activation. Platelet dysfunction is commonly observed after procedures performed under     cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding     in the postoperative period.      Coating of the surface has been shown to diminish these effects.Biocompatible surfaces,     extracorporeal circulation technologies mimic critical characteristics of the vascular     endothelium to provide thromboresistance and enhanced blood compatibility. Recently, a new     physiologic non heparin coating with different functional aspects was developed as an     alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer     Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system     (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood.     The aim of this study is to compare the influence of a Balance - coated CPB system in     pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation     and hemostatic activation.   "
125062|NCT01648699|"     The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral     System (OROS) hydromorphone using standardized conversion from prior opioid therapy among     participants with cancer pain.   "
125063|NCT01648686|"     The purpose of this study is to determine whether the oral alendronate treatment of     post-menopausal osteoporosis could be a risk factor for jaw bone healing after dental     extraction.   "
125064|NCT01648673|"     The main purpose of this pilot study is to evaluate an impact of JHI CR Platform on patient     referral, recruitment and retention rates and overall patient satisfaction in cardiovascular     rehabilitation programs at the HFHS.   "
125065|NCT01648660|"     The primary objective of LUTEGA 2 is it to determine the long term effect (about 2 more years     after LUTEGA 1, NCT00763659) of the supplementation with a fixed combination of     lutein/zeaxanthin and omega-3- fatty acids in two different dosages on the optical density     (OD) of macular pigment in patients with non- exudative age related maculopathy. The dosage     groups are crossed after LUTEGA 1.   "
125066|NCT01647594|"     This is a pilot study, which will inform a larger study to evaluate the Young Women's     Intervention (YWI). The goal of this research is to develop, implement and test a refined     exportable and sustainable education and support intervention for young women with breast     cancer and their oncology providers. This pilot study will test the feasibility of the Young     Women's Intervention (YWI) as well as a Physical Activity Intervention (PAI) at four unique     sites. In addition, it will include a qualitative assessment, through focus groups and key     informant interviews, of concerns facing young women with breast cancer. The investigators     aim to use the findings from this pilot study to inform a larger future Young Women's     Intervention (YWI) study where the YWI intervention will be compared to a Physical Activity     Intervention (PAI).   "
125067|NCT01647581|"     A randomized trial aimed at determining whether or not hemoclips are effective in preventing     post-polypectomy bleeds on polyps that are 10mm in size or greater.   "
125068|NCT01647568|"     At our VA hospital, in general, it is the policy of our GI lab to not stop our patients     anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we     believe the risk of stopping these sort of medications outweigh the risks of a complication     from a colonoscopy.      Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any     anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We     perform the procedure just like we normally would and then follow-up with the patient 7 and     30 days after their procedure.   "
125071|NCT01647529|"     Objective of this study is to investigate the intracameral level of ganciclovir following     topical application of 0.15% ganciclovir gel (VIRGAN©) for Cytomegalovirus (CMV) anterior     uveitis and endothelitis. Thirty patients who are diagnosed with CMV anterior segment     infection, either uveitis or endothelitis, who have a positive aqueous real time PCR (RT-PCR)     and/or positive tetraplex PCR for CMV and have not had any form of ganciclovir treatment in     the past 1 month, will be recruited in the study after taking an informed consent. with     active CMV anterior segment infection confirmed by a positive aqueous real time PCR (RT-PCR)     and have not had any form of ganciclovir treatment in the past 1 month were recruited in the     study. Patients were given 0.15% ganciclovir gel 1cc 5 times a day for 6 weeks. Following 6     weeks of treatment, tears and aqueous samples will be collected. Aqueous will be sent for     RT-PCR for CMV status. Ganciclovir drug level in both tears and aqueous will be measured by     HPLC method. Clinically, degree of the intraocular inflammation, Intraocular pressure (IOP)     and central corneal thickness (CCT) will be recorded at baseline and post-treatment.   "
125072|NCT01648647|"     Copeptin is accepted as a marker of stress. We want to evaluate the preoperative and early     postoperative copeptin leavens in patients undergoing different aortic valve procedures   "
125073|NCT01648634|"     The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the     development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15     year-old.   "
125074|NCT01648621|"     Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases     referred to as comorbidities. Often these patients require health care by a variety of health     care professionals from services linked to hospitals and in the community. Unfortunately,     sometimes it may be difficult for these patients to receive appropriate care in a timely     manner resulting in a trip to the emergency department. As well, patients may benefit from     education that enables them to recognize early signs indicating they are getting sicker and     to self-manage their disease. Our study will examine a strategy that includes a case manager     who will make weekly phone contact with COPD patients with comorbidity that present either to     the emergency department or are admitted to hospital. Weekly contact will focus on teaching     patients to recognize worsening symptoms and self-management strategies. The case manager     will work with patients, caregivers, community health care providers and hospital specialists     to promote communication and optimize care delivery. The investigators will examine the     impact of our intervention on the need for emergency department visits and hospital     admission. The investigators will also examine the impact on patients' health related quality     of life, number of COPD exacerbations, and disease progression.   "
125259|NCT01645748|"     The purpose of this study was to evaluate the tolerability and efficacy of a combination of     weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with     locally advanced head and neck squamous cell carcinoma (HNSCC).   "
125078|NCT01648569|"     Although the vast majority of patients with Papillary Thyroid Microcarcinoma (PTMC) have     excellent long-term outcomes, some patients experience tumor recurrence, either locally or,     less frequently, as distant metastases, with some patients dying due to this disease. The     natural course of PTMC has not always been universally accepted, thus creating controversy     concerning the diagnosis and treatment of PTMC. Further, it is not yet possible to     confidently identify PTMCs that would take aggressive courses if left untreated. Treatment     recommendations range from observation alone to vigorous intervention featuring total     thyroidectomy, prophylactic cervical lymph node dissection, and adjuvant RI ablation.     Therefore, no consensus has yet been reached on the biological aggressiveness of PTMC or on     which therapy is the most appropriate. Moreover, the impact of several clinicopathologic risk     factors, including tumor size, is unclear, although patients with tumors ≤ 0.5cm in diameter     may have a better prognosis than patients with tumors 0.5-1 cm in size.      Most studies evaluating the proper extent of surgery for PTMC have been retrospective in     design. A prospective, long-term, randomized study in a large number of patients, however,     may not be feasible owing to the need for an extensive follow-up duration, the costs     associated with such a study, and, particularly, its ethical constraints. Consequently, it is     not currently possible to determine the prognosis of patients with PTMC or the proper     therapeutic approach in these patients. The investigators therefore compared long-term     outcomes after total thyroidectomy (TT: total or near-total thyroidectomy) or less than total     thyroidectomy (LT: lobectomy or subtotal thyroidectomy) in a large cohort of patients with     PTMC, using propensity-score matching to adjust for the uncontrolled assignment of surgical     extent in these patients. In addition, the investigators evaluated whether tumor size, ≤ 0.5     cm or > 0.5 cm, had a significant impact in determining the extent of surgery in patients     with PTMC.   "
125079|NCT01648556|"     It is about a multicentric study prospective of more than patients' 60 years with a     thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so     certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO,     the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis     of PTI.   "
125080|NCT01648543|"     Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best     method of lumbar sympathetic ganglion block is not established. The investigators would     compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's     entry point is 7~7.5cm from midline of spinous process of lumbar spine. The other is angular     method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison     modified Reid method with angular method would be helpful for finding best method of lumbar     sympathetic ganglion block.   "
125081|NCT01648530|"     This is a population internet-based study to characterize migraine clinical course and impact     on family.   "
125082|NCT01648517|"     This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using     chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and     RRM1 of the tumor cells.   "
125470|NCT01642784|"     Objective of this registry study is to compare strategy of complete vs. target lesion-only     primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST     elevation myocardial infarction) patients.   "
125083|NCT01648504|"     The investigators will attempt to improve the patient experience before colonoscopy. The     investigators will provide an in-office ipad video series and an electronic web guide to help     patients learn all the best ways to prepare for colonoscopy. The investigators will then     follow the patients who receive this eGuide to colonoscopy and observe whether or not they     enjoyed the additional access to information from their providers, and will monitor whether     or not they were better prepared for their colonoscopy.   "
125084|NCT01648491|"     Determine safety and effectiveness of the technique using autologous stem cells in the     treatment of urinary incontinence in one male subject.   "
125085|NCT01648478|"     Previous studies have demonstrated defects in the trafficking and translocation of GLUT4     glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin     resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which     collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin.     The extracellular domain of IRAP is cleaved and released in the bloodstream.      Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.      In this study the investigators seek to confirm this hypothesis by using the gold standard of     insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.      It is a multicenter descriptive study.   "
125086|NCT01648465|"     The purpose of this study is to explore the efficacy and safety of everolimus administered as     a first-line treatment in newly-diagnosed patients with advanced or inoperable     Gastrointestinal (GI) or pancreatic neuroendocrine tumors.   "
125087|NCT01648452|"     Background:        -  Achromatopsia is an inherited condition that causes vision loss because cells in the          retina do not work properly. It causes loss of acuity, sensitivity to light, and loss of          color vision. There are no effective treatments for achromatopsia.        -  Four genes currently are known to cause achromatopsia. One of these, the cyclic          nucleotide-gated channel beta 3 (CNGB3) gene, is the cause in about 50 percent of          people.        -  CNTF is a natural chemical found in the body that promotes survival and function of          nerve cells. CNTF has been shown to be effective in treating retinal disease in animals          and can slow vision loss.        -  CNTF has also been studied in over 250 people with retinal disease other than          achromatopsia. In these studies, a CNTF implant was placed into the eye during a simple          surgery. The implant releases CNTF inside the eye, near the retina. These studies          suggested that a CNTF implant might help vision in some eye diseases.      Objectives:        -  To learn whether a CNTF implant is safe for people with CNGB3 achromatopsia.        -  To learn whether CNTF can improve visual acuity or color vision, and whether it may          reduce sensitivity to light in people with CNGB3 achromatopsia.      Eligibility:      You may be able to take part in this study if you:        -  Are at least 18 years old.        -  Test positive for mutations in the CNGB3 gene and have no mutations in another          achromatopsia gene.        -  Have 20/100 vision or worse in at least one eye.        -  Are not pregnant or nursing.      Design:        -  To determine if you can take part, we will ask about your medical history and do a          physical examination and an eye examination. Blood and urine samples will be taken.        -  This study requires 11 visits to the National Eye Institute over 3 years.        -  One visit will be for the implant surgery. The implant will be placed in one eye only.        -  Study visits will take place 1 day after implant surgery, and again 1 week later and 1          month, 3 months, 6 months, 1 year, 1.5 years and 3 years later. These visits will help          us evaluate the safety and benefit of the implant on your eye.        -  At the 3 year visit, you can choose to keep the CNTF implant in your eye, or you can          have us remove it.   "
125088|NCT01648348|"     This partially randomized phase I/II trial studies the side effects and the best dose of     anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how     well they work in treating patients with glioblastoma multiforme that has come back.     Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may     find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together     with bevacizumab may be an effective treatment for glioblastoma multiforme.   "
125144|NCT01647620|"     A study to investigate the concentrations of a new drug DPOC-4088 in blood, and to study the     effect of this drug on blood clotting parameters. Furthermore the relation between the blood     concentrations and the blood clotting effect will be investigated. Safety will be     investigated as well. The objective of these investigations is to determine the optimal dose     of DPOC-4088 that, achieves a relevant increase in a specific blood clotting parameter (the     ecarin clotting time) without safety concerns.   "
125089|NCT01648335|"     Dislocation of the glenohumeral joint of the shoulder is a common orthopedic clinical     problem. The majority of the dislocations are anterior (about 95%) while the rest are     posterior and inferior. After reduction of the initial dislocation, the treatment's goal is     to prevent recurrent dislocations. In spite of treatment, the recurrence rate is 80-90% in     the population aged 18-29. There is an age-related decrease in the recurrence rate, with the     only 2-3% for ages 60-70. It has been calculated that 1 in 200 soldiers in the Israeli Army     between the ages of 17 and 33 suffers from recurrent shoulder dislocations [1].      The traditional treatment for primary (first-time) shoulder anterior dislocation has been     immobilization of the shoulder in internal rotation in a soft dressing called universal     shoulder immobilizer (USI) for 3-6 weeks. However, there is a lack of evidence-based     information to demonstrate the effectiveness of this treatment. Posterior dislocations are     immobilized in external rotation. Work presented previously in the Orthopaedic Research     Society and more recently at the American Academy of Orthopaedic Surgeons suggests that     immobilization of the shoulder after reduction of anterior dislocation is best in external     rotation and not in internal rotation. MRI studies have shown that the labral tear, which is     the hallmark of most traumatic anterior dislocations, is best reduced to its anatomical     position when the shoulder is immobilized in external and not in internal rotation.     Preliminary data indicates that immobilization in external rotation of the primary traumatic     shoulder dislocations may lower the incidence of reoccurrence.      The traditional shoulder immobilizer is a generic bandage produced by several companies. In     the current study, the investigators will use a USI distributed by Uriel® company (Uriel     #87), which can be modified to hold the shoulder in external rotation.   "
125090|NCT01648322|"     This is a randomized open label dose finding study to evaluate the efficacy and safety of     F-627 on women with Stage II-III breast cancer receiving chemotherapy treatment.   "
125091|NCT01648309|"     The purpose of this study is to examine the neuropsychological effects of transvascular     aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive     heart failure and low cardiac output which may limit their cognitive abilities. TAVI results     in significant improvements in cardiac function and therefore may improve cognitive     functions. However, TAVI may also be associated with stroke and may therefore have a negative     impact on cognition. Therefore, in this study the investigators wish to perform a battery of     standardized neuropsychological tests before and after TAVI to test the net effects of TAVI     on cognitive performance over time.      The investigators plan to include all patients planned to have TAVI in the study and to test     them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.   "
125092|NCT01648296|"     A single center, open-label baseline controlled imaging study to designed to assess whether     Positron Emission Tomography (PET) measurements of myocardial Fatty Acid (FA) metabolism     performed with [18F]FluorbetaOx correlates with measurements using [11C]palmitate. This study     involves the investigational use of a PET radioactive tracer, fluorine-18 radiolabeled fatty     acid analog, [18F]FluorbetaOx designed to measure beta oxidation of fatty acids in the     myocardium. The investigators propose to evaluate the feasibility of the method in heart     failure patients with dilated non-ischemic cardiomyopathy (DCM) with or without type-2     diabetes mellitus (T2DM) and obese subjects (Body Mass Index of ≥ 30kg/m2) with or without     T2DM and normal healthy subjects to provide a wide range of perturbations in myocardial FA     metabolism.      Specific objectives include:        1. To assess the diagnostic quality of [18F]FluorbetaOx PET images and kinetics at the          proposed 10 millicurie (mCi) dose.        2. To quantitatively determine the relationship between PET measurements of myocardial FA          metabolism obtained with [18F]FluorbetaOx and those using [11C]Palmitate.        3. To calculate human dosimetry based on the human biodistribution of [18F]FluorbetaOx.        4. Correlate measurements of myocardial FA metabolism with changes in left ventricular          (LV)structure and function performed on a clinically indicated echocardiography at 6-9          months after imaging.   "
125095|NCT01648257|"     This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods)     in healthy adult subjects. During each period, subjects will receive a single dose of     GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8     days) and safety assessments will be performed. Each period will be separated by a washout     period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose     of study drug.   "
125096|NCT01648244|"     The primary purpose of this study is to determine whether the use of CADS by primary care     providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care     relative to a usual care group in terms of objective outcome measures of glycemic control     (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of     subjective ratings by patients.   "
125097|NCT01648231|"     The purpose of this study is to evaluate the comparative bioavailability of two fixed dose     combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects     will receive each of the following three treatments administered in a randomized three-way     crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg     losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg     losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg     losartan; all three treatments will be administered once orally and in a fasted state. Serial     blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of     amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite).     Safety assessments will include measurements of orthostatic vital signs, electrocardiograms     (ECG), collection of adverse events (AE) and clinical laboratory tests.   "
125098|NCT01648218|"     No consensus guidelines exist for management of post-transplant glucocorticoid induced     hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety     of insulin regimens have been proposed, including mealtime short-acting regular or analog     insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal     insulin alone such as glargine or detemir. However, no randomized trial has ever examined     different insulin regimens to determine which most effectively controls post-transplant     steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three     commonly used insulin regimens used for managing post-transplant once-daily     glucocorticoid-induced hyperglycemia to determine which is most effective:        -  Group 1: Intermediate-acting (NPH) insulin at breakfast        -  Group 2: Short-acting insulin (regular or aspart) before meals        -  Group 3: Insulin glargine at breakfast      Question/Hypothesis:      Among three commonly used insulin regimens, which is most effective for managing     post-transplant once-daily glucocorticoid-induced hyperglycemia?   "
125099|NCT01648205|"     The purpose of this study is to determine whether late sodium channel blockade might be     effective in shortening the QTc interval in various LQT3 mutations and be considered as a     safe therapeutic option for LQT3 patients.   "
125260|NCT01645735|"     The purpose of this study is to determine whether ceftaroline is effective and safe for the     treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for     infection due to Methicillin-resistant Staphylococcus aureus (MRSA).   "
125100|NCT01648192|"     This study is the first study of losmapimod in Japanese subjects. This study will be a     single-center, single blind, phase I and two part study to characterize the safety,     tolerability, pharmacokinetic and pharmacodynamic profiles in healthy Japanese volunteers     (male and female of non-childbearing potential). Part1 will be a single dose, randomized,     three-period, placebo-controlled and dose escalation part. Each subject will participate in 3     dosing sessions, and receive, on separate days, three of four treatments of losmapimod 2.5,     7.5 and 20 mg, and the matching placebo in the fasted state after overnight fast (at least 10     hours). The design incorporates sufficient washout between treatments (at least 7 days after     the previous administration), and is an efficient design for the study objectives. Part 2     will be a fixed dose and placebo-controlled part. Each subject will participate in one dosing     session, and receive losmapimod 7.5 mg or the matching placebo twice daily in the fasted     state for 14 days. Only subjects will be blind to the sequence and dose studied. The study     will include the placebo treatment to allow a valid evaluation of adverse events attributable     to treatment versus those independent of treatment. Approximately 18 subjects in each part     will receive treatments of losmapimod and/or placebo in the design. The primary objective of     the study is to characterize the safety and tolerability of single doses and repeat doses of     losmapimod in healthy Japanese subjects. Serial pharmacokinetic samples will be collected and     safety assessments will be performed following each dose.   "
125101|NCT01648179|"     This study is an open-label, randomized, single dose, four period, balanced crossover study     to assess in eligible healthy male or female subjects.   "
125102|NCT01648166|"     This is a research study about the relationship between lung cancer and environmental risk     factors. The purpose of this study is to try to understand the effects of trace elements such     as arsenic and chromium, as well as radon on the development of lung cancer. To do this, the     investigators will collect information and environmental and biologic specimens from people     who live in Appalachian Kentucky who a) have lung cancer or b) don't have lung cancer and     will serve as control subjects. The investigators will create a specimen repository of from     these people and their residences to compare differences in many risks factors for cancer. By     doing this study, the investigators hope to learn why there are more lung cancers in     Kentucky's fifth Congressional District than anywhere else in the nation.   "
125103|NCT01648153|"     GSK1070806 is a humanised IgG1/kappa antibody which is directed against the soluble cytokine     interleukin-18 (IL-18). The aims of this placebo controlled study are to evaluate the     efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1070806 in obese     subjects with Type 2 diabetes mellitus (T2DM), and to gain a better understanding of the     mechanism by which GSK1070806 exerts its therapeutic effects.   "
125104|NCT01648140|"     GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being     developed for the treatment of chronic HCV infection. This Phase II, multicenter,     parallel-group, randomized, dose-ranging study will assess the safety and tolerability,     antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in     combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100     treatment-naïve subjects with chronic genotype 1 HCV infection.      In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with     genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of     GSK2336805.   "
125107|NCT01648101|"     The immediate release (IR) formulation of retigabine has been shown to be superior to placebo     as adjunctive therapy in 3 adequate and well-controlled studies in subjects with     drug-resistant partial-onset seizures (POS) who had previously failed to respond to two or     more antiepileptic drugs (AEDs) and were still having seizures despite current treatment with     1, 2, or 3 AEDs. However, of 1244 subjects randomly assigned to treatment in these 3 clinical     studies, only 10 were Asian subjects and only 5 of these Asian subjects were randomly     assigned to treatment with retigabine. Therefore, this Phase III study is being conducted to     evaluate the efficacy, safety and tolerability, and health outcomes of retigabine, at doses     of 900 mg/day and 600 mg/day, compared with placebo in adult Asian subjects with     drug-resistant POS.   "
125108|NCT01648088|"     The presence of Staph in/on a patient who will undergo total joint replacement is a risk in     that the patient could go on to develop infection at the surgery site after surgery. The     purpose of this study is to evaluate if it is beneficial to to administer a questionnaire and     obtain cultures from various body sites from patients prior to surgery and also to determine     which body site(s) provide the best source of possible staph presence. If the pre operative     cultures indicate staph is present, an Infectious Disease specialist will be consulted for     standard of medical care consultation and treatment management. All patients scheduled to     have total joint arthroplasty are eligible to participate. The research team will follow the     study patients for 2 years after they undergo prosthetic joint implantation to monitor for     development of prosthetic joint infection.   "
125109|NCT01648075|"     Probiotics are microorganisms that when administered in adequate amounts can confer health     benefits. In vitro and clinical studies support the idea that lactobacilli have protective     effects on oral health. A recent study in which preschoolers consumed milk drinks enriched     with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits     to children.      The aim of this study is to evaluate the effect of daily consumption of milk beverages     enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean     children.   "
125110|NCT01648062|"     This randomised controlled trial assessed the efficacy of four mental imagery techniques for     improving sleep and its related behaviour: (1) imagery focused on reducing arousal levels;     (2) imagery incorporating implementation intentions (a strategy designed to link specified     behaviour with the anticipated context) for sleep-related behaviour; (3) a combination of     imagery using arousal reduction and implementation intention strategies; or (4) a condition     where participants were asked to imagine their typical post work activities.   "
125275|NCT01645332|"     This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with     12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic     control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and     2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin     level, lipid profile, and body weight.   "
125111|NCT01648049|"     Insomnia and depression are two of the most prevalent mental health disorders and often     co-occur.      Health disparities in rural America and among African-Americans are well documented. The     investigators propose an R34 exploratory project to test the feasibility of delivering     high-fidelity insomnia and depression psychological services to an underserved population.     Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural,     predominantly African-American older adults who present to their primary care physician with     co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10)     focusing on treatment development/refinement and patient acceptability. In stage 2,     feasibility will be experimentally tested with 46 participants randomized to integrated     cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot     study. The treatment will combine/integrate compact CBT for insomnia (including relaxation,     sleep restriction, and stimulus control) and for depression (including cognitive therapy and     behavioral activation). The experimental intervention comprises delivering CBT services by     videoconferencing to patients in primary care settings who live in rural areas. Treatment     will be evaluated by pre, post, and follow-up self report instruments on insomnia,     depression, and quality of life. In addition, the stage 1 pilot will use investigator     designed quantitative and qualitative measures to evaluate critical process variables     including patient acceptability of the video format, patient acceptability of the treatments,     and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated     into stage 2 as well. Several innovative features of this exploratory project include:     intervening with CBT on both disorders hoping to gain a synergy by their combined     presentation; use of telehealth to deliver treatment to distant locations; translation of     efficacy findings to an effectiveness trial; treatment will be delivered in the primary care     setting, the preferred locale of rural, older adults; the study will extend knowledge of the     range of CBT applications by enrolling under-represented groups with respect to ethnicity,     literacy, and financial resources.      The primary aims of this project are (1) to determine the feasibility and maximal therapy     characteristics of integrated CBT for co-occurring insomnia/depression in both the case study     series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on     whether participants receiving integrated CBT + usual care show comparable or greater     reductions in insomnia symptoms compared to participants receiving usual care at     posttreatment and follow-up, and (3) collect pilot data on whether participants receiving     integrated CBT + usual care show comparable or greater reductions in depression symptoms     compared to participants receiving usual care at posttreatment and follow-up.   "
125112|NCT01648036|"     Life-threatening infections account for 10% of all intensive care unit admissions and     constitute the second more frequent cause of death in the ICU after heart diseases. The most     common cause of death in patients admitted with life-threatening infections is multi-organ     failure that is mediated by severe inflammation. Given the relationship between inflammation     and blood clotting, blood-thinners (also called anticoagulants) have been used to decrease     inflammation and the formation of small clots. Several lines of evidence suggest that     heparin, a proven and inexpensive blood-thinner, may reduce improve survival in patients     diagnosed with life-threatening infection. The primary objective of this study is to     demonstrate the feasibility of enrolling patients in a large randomized controlled trial     investigating heparin in patients with severe infections. In this study, patients with     life-threatening infections will have an equal chance of receiving an intravenous infusion of     heparin, or a low dose of a similar drug to prevent of blood clots while patients are     immobile. The primary purpose of the study is to demonstrate that an average of 2 patients     per site, per month, can be enrolled. Other measures of feasibility include the consent rate,     the number of protocol violations that occur during the trial, and the number of dose     reductions needed due to excessive anticoagulation. To study the biologic effects of heparin     in patients with severe infection, specific laboratory markers will be measured and analyzed.     If the feasibility of the trial is confirmed, a large randomized trial designed to tell if     heparin can safely improve survival will be conducted. Given its low cost and availability,     if heparin is shown to improve survival in patients with severe infection, adoption of this     therapy on a global scale is anticipated.   "
125113|NCT01648023|"     The purpose of this study is to find out if the combination of trans-arterial     chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more     effective than just receiving the infusional chemotherapy alone.   "
125114|NCT01648010|"     The purpose of this study is to evaluate the safety of intravesical instillation of TC-3     Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary     bladder.   "
125128|NCT01647828|"     The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD)     of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2,     multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of     OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously     untreated stage IV pancreatic cancer.   "
125115|NCT01647997|"     Sepsis is characterized by hyperlactatemia, the severity of which is proportionate with     sepsis severity. The pathophysiological mechanisms (increased lactate production vs decreased     lactate utilization; tissues involved in sepsis-induced lactate production) remain largely     unknown.      In this study, the investigators will assess whole body and regional metabolism in healthy     young male subjects on two occasions, once after administration of an intravenous bacterial     endotoxin challenge, and once without intervention.      In one group of subjects, whole body lactate metabolism will be measured over 10 hours after     the endotoxin challenge        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)        -  Glucose kinetics (measured with 6,6 d2 glucose)        -  Hemodynamic parameters and body temperature        -  Blood clinical chemistry In one group of subjects, whole body lactate metabolism will be          measured over 10 hours after the endotoxin challenge        -  Energy expenditure and net substrate oxidation rates (indirect calorimetry)        -  Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)        -  Glucose kinetics (measured with 6,6 d2 glucose)        -  Hemodynamic parameters and body temperature        -  Blood clinical chemistry      In a second group of subjects, regional muscle lactate metabolism will be measured over 10     hours after the endotoxin challenge by means of muscle microdialysis   "
125116|NCT01647984|"     Study on the role of a combination of nutraceuticals (Ritmonutra) with an effect on benign     supraventricular and ventricular extrasystoles in subjects free of a specific organic heart     disease. It has been suggested treatment with a nutritional supplement, able to normalize the     'cardiac electrophysiology' and help to maintain wellness. Ritmonutra ® is a combination of     nutraceuticals®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and     Vitamin E, help to normalize the heart pacing, reducing the total number of benign     extrasystoles and consequently improving the quality of life.   "
125117|NCT01647971|"     The purpose of this study is to determine whether ublituximab is safe and effective in     patients with relapsed or refractory B-cell lymphoma who were previously treated with     rituximab.   "
125118|NCT01647958|"     The purpose of this study is to assess the efficacy and safety of Transoral Incisionless     Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI)     therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with     refractory symptoms on Proton Pump Inhibitors (PPIs).   "
125119|NCT01647945|"     Mutations in bone morphogenetic protein receptor 2 (BMPR2) are present in >80% of familial     and ~20% of sporadic pulmonary arterial hypertension (PAH) patients. Furthermore     dysfunctional BMP signaling is a general feature of pulmonary hypertension even in     non-familial PAH.      We therefore hypothesized that increasing BMP signaling might prevent and reverse the     disease. We screened > 3500 FDA approved drugs for their propensity to increase BMP signaling     and found FK506 (Tacrolimus) to be a strong activator of BMP signaling. Tacrolimus restored     normal function of pulmonary artery endothelial cells, prevented and reversed experimental     PAH in mice and rats.      Given that Tacrolimus is already FDA approved with a known side-effect profile, it is an     ideal candidate drug to use in patients with pulmonary arterial hypertension.      The aims of our trial are:        1. Establish the Safety of FK506 in patients with PAH.        2. Evaluate the Efficacy of FK506 in PAH        3. Identify ideal candidates for future FK506 phase III clinical trial.   "
125120|NCT01647932|"     The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics     with thiazide-type diuretics) is more effective (in terms of improving fluid overload     symptoms) among patients with decompensated heart failure in comparison with loop diuretic     alone.   "
125121|NCT01647919|"     The purpose of the study is to examine the efficacy of cogniVida™ on learning and memory     performance (executive function, associative, spatial and verbal memory) as well as on mood     and attention parameters after four, eight and eleven weeks of supplementation and in     comparison with placebo.      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by     the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug     Administration does not strictly regulate herbs and dietary supplements. The investigators do     not claim that this supplement is meant to treat any ailment.   "
125122|NCT01647906|"     The purpose of this observational study is to evaluate the safety and effectiveness of the     Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a     real world setting.   "
125123|NCT01647893|"     A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose     Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001     Intravenously Administered in Healthy Male Subjects   "
125124|NCT01647880|"     In the MOVING study should be examined, whether early therapeutic intervention with     fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a     comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual     evoked potentials (mVEP) after 6 month compared to baseline.   "
125125|NCT01647867|"     Our project, established through collaboration between clinicians (Oscar Lambret     Center-University Hospital) and scientists (IBL), aims to evaluate the expression of Met     fragments in the lung cancer (LC). Unlike previous studies on Met by sequencing, in situ     hybridization or immunohistochemistry, the investigators propose a protein analysis by     Western blot of tumor samples and healthy tissue. This approach will evaluate the expression     of full-length receptor, the potential presence of intracellular fragments, and their     phosphorylation status.   "
125126|NCT01647854|"     The aim of the study is to investigate the safety and efficacy of the operation of a     prehospital teleconsultation system in the Emergency Medical Service.   "
125127|NCT01647841|"     The purpose of this study is to understand how differences in the nutritional status and     concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant     women living in a semi-rural and rural region of northern Tanzania affect fetal growth,     pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+     women will have worse nutritional status and a greater degree of cachexia which will     negatively impact fetal growth, pregnancy outcomes and early infancy health and development.   "
138766|NCT01468389|"     The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine     With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer     is effective and safe.   "
125130|NCT01647802|"     The main objective of this study is to evaluate via a physiological analysis of the movements     involved in standing, the level of forward flexion of the spine (in cm on the horizontal     axis) obtained with the apparatus Tina and to compare levels obtained in the same patients     with stander/transfer devices Turner and Vertic'Easy.   "
125131|NCT01647789|"     This study will assess the safety and preliminary antitumor activity of CFG920, a new CYP17     inhibitor in castration resistant prostate cancer patients who are abiraterone naive or     abiraterone resistant.   "
125132|NCT01647776|"     The investigators propose a screening population-based study to systematically evaluate the     accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy     screening. In addition, the investigators propose a genetic epidemiologic study of the     relation between colon polyps, an established precursor of colon cancer, and two factors that     may influence risk for colon cancer: candidate genes and diet.   "
125133|NCT01647763|"     Background:      Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive     procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less     postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy     are examples for such modern procedures. Hemorrhoidal artery ligation causes less post     operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate.     Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence     rate without increasing the post operative pain.      Hypothesis and aim:      The study tries to prove the assumption that combined hemorrhoidal artery ligation and     rectoanal repair cause less pain and have less post operative complications than stapled     hemorrhoidopexy.   "
125145|NCT01647607|"     The purpose of this study is to address gaps in care of young women with breast cancer by     determining whether educational interventions focusing on issues unique to young women with     breast cancer and healthy lifestyles for women with breast cancer help to improve care of     young breast cancer patients. The investigators believe that if addressed early in a young     woman's care, concerns related to fertility, body image, sexual dysfunction, and physical     activity will improve the satisfaction with care and quality of life of this vulnerable     population. The research will be conducted by exporting refined, previously piloted     educational interventions to 14 academic sites and 40 community medical clinics. The     investigators will compare how interaction with each intervention affects patients' quality     of life and satisfaction with quality of care.   "
125134|NCT01647750|"     All patients with hypothyroidism are currently treated the same way, regardless of age. The     investigators want to look at whether people aged 80 years or older would benefit from being     treated with lower doses of levothyroxine. There are three reasons why the investigators     think this could be beneficial, but this is not yet proven:        1. Some older people with hypothyroidism may have few symptoms.        2. Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patient's blood          to decide the dose of Thyroxine received. The standard normal TSH range used to          determine the dose of levothyroxine is from younger people. The investigators wonder          whether this is appropriate to all age ranges particularly as the investigators know          that older people may normally have higher TSH values.        3. If TSH levels are too low there may be a slight increased risk of problems such as          brittle bones or an irregular heartbeat.      The best way to test whether older people benefit from lower doses of levothyroxine is by a     large clinical trial. Before the investigators can do this, the investigators need to run a     smaller clinical trial called a pilot study (SORTED 1) to examine whether this is practical     and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or     above.      Participants will be randomly allocated to receive their routine or lower dose of     levothyroxine. Follow-up will be conducted over approximately 25 weeks.      The investigators also propose a qualitative study (SORTED 2) to specifically understand     patient's willingness to take part in a RCT and participant's experience of the intervention.      Finally, the investigators propose a retrospective cohort study of 400 treated hypothyroid     patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of     studying outcomes after 4 years. The cohort study will collect data required to inform a     sample size calculation for a future full study where the primary outcome will be 4 year     mortality.   "
125135|NCT01647737|"     The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia     patent pending formulation of natural plant extracts on patients with xerostomia. The major     component of this formulation is green tea extract with a defined composition of polyphenols.     Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects     on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any     marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there     is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in     green tea extract, having properties consistent with effects on cells of tissues that would     be protective towards local inflammation.   "
125136|NCT01647724|"     The opportunity of a home, self-collected sample, opens the chance to remove some of the     barriers that may discourage women from participating to screening programmes or performing     HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as     compared with tests performed at a clinic. It allows for privacy, reduces discomfort and     women know nobody would have to handle their body.      Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women     at cervical cancer screening.   "
125137|NCT01647711|"     This trial is divided into Part A and Part B. The primary objective of Part A is to establish     the Maximal Tolerated Dose of intermittent high dose afatinib. The primary objective of Part     B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M     mutations to a dose of intermittent afatinib established in Part A.      The secondary objective is to explore tumor response and tumor-derived biological markers of     response to afatinib, as well as pharmacokinetic parameters of afatinib.   "
125138|NCT01647698|"     This project will investigate the feasibility and preliminary effectiveness of an intensive     and focused working memory training program for patients in the early stages of PD receiving     dopaminergic therapy. The investigators hypothesize that working memory training will be an     effective method of improving working memory and related cognitive and behavioural functions     in PD patients.   "
125139|NCT01647685|"     A promising strategy to reduce CVD is to directly target inflammation at the level of the     vessel wall. A potential drawback of anti-inflammatory strategies pertains to the thin line     between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression. One of     the strategies to limit systemic immunosuppression is to strive for local delivery and     prolonged efficacy and low systemic burden of the drug by encapsulating the compound in     liposomes.      Liposome-encapsulated drugs efficiently target lesions and accumulate at a much higher extent     at desired areas of interest. Thus, local delivery and prolonged efficacy can be very     important tools to overcome the potential drawback anti-inflammatory drugs; namely an     inappropriate immune suppression. In the present project, the investigators therefore aim to     evaluate the delivery and superior efficacy of Nanocort above Prednison or placebo in     patients with peripheral artery disease due to atherosclerosis. Because these patients will     undergo an endarteriectomy the investigators will be able to collect atherosclerotic material     after drug administration and thus evaluate the local delivery and compare the effects of     Nanocort to Prednison or Placebo.   "
125140|NCT01647672|"     Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them     with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as     neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of     Albumin-bound Paclitaxel.   "
138767|NCT01468376|"     The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx.   "
125141|NCT01647659|"     The purpose of this open-label, randomized, 2-treatment, 2-period crossover study with     incomplete washout is to evaluate the relative bioavailability of 2mg GSK1120212 pediatric     oral solution formulation in comparison to 2mg GSK1120212 tablet formulation, to investigate     the safety and tolerability of a single dose of the GSK1120212 pediatric oral solution     formulation as compared to a single dose of the GSK1120212 tablet formulation, and to     investigate the palatability of the GSK1120212 pediatric oral solution formulation.      Subjects will be assigned to one of two possible treatment sequences according to the     randomization code provided to the sites by GSK: a single dose of 2mg GSK1120212 pediatric     oral solution formulation then a single dose of 2mg GSK1120212 tablet formulation, or a     single dose of 2mg GSK1120212 tablet formulation, then a single dose of 2mg GSK1120212     pediatric oral solution formulation. Administration of GSK1120212 in either sequence will be     followed by 7 days of serial blood sampling for pharmacokinetic analysis of plasma     GSK1120212. Safety assessments, including assessment of adverse events, clinical laboratory     values (hematology, clinical chemistry and urinalysis) and vital signs, will be made     throughout the study. After completing the pharmacokinetic assessments for two periods,     eligible subjects may transition to MEK114375, an open-label rollover study of GSK1120212.   "
125142|NCT01647646|"     In real life, the investigators will be using different strategies including SMART therapy or     other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.   "
125146|NCT01647516|"     The purpose of this study is to determine whether RPC1063 is effective in the treatment of     ulcerative colitis (UC).   "
125147|NCT01647503|"     Primary hyperparathyroidism (PHPT) is one of the common endocrine disorders. The major     clinical symptoms involve stones, bones, abdominal groans and psychiatric moans. Increased     parathyroid cell proliferation and decreased calcium-mediated control of the PTH secretion     are characteristic findings. The most common cause of PHPT is adenoma followed by hyperplasia     and carcinoma.The molecular mechanisms involved in parathyroid tumorigenesis are partially     known. Few genes have been identified and their roles are under study.      The genes which are under study by different groups are unable to give a definite direction     towards the understanding of parathyroid tumorigenesis and the mechanism involved in     overgrowth of parathyroid tissue. So identifying different proteins and their regulation     pattern from adenomas to carcinomas will be the initial steps towards understanding the     proteins involved in tumorigenesis of parathyroid tissues. By using proteomics approach one     can generate protein level information. In this study, using a combined approach based on 2 D     gel electrophoresis and mass spectrometry (MS), the investigators propose to study a     comparative proteomics to examine the changes of protein profiles in parathyroid tumor     tissues with normal and hyperplasic parathyroid tissues. This work plan will help us to     understand differentially expressed proteins in patients with PHPT. This will help in     understanding the disease and identifying better diagnostic and curative measures of the     disease. The investigators are also planning to access nuclear morphometry changes in     sporadic parathyroid tumors. It will help in establishing cellular and nuclear change pattern     variations from normal to parathyroid tumors.   "
125148|NCT01647490|"     This study is a long-term, prospective, and controlled evaluation of the mechanical     dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and     stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an     alternative pacing site through measures of dyssynchrony in acute and chronic.   "
125149|NCT01647477|"     This study aims to determine the impact of sociocognitive and emotional factors on the time     of the initial consult   "
125150|NCT01647464|"     Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study     is to determine whether there is retention of ultrasound contrast agents in the renal     microcirculation, which has been described in mice.   "
125151|NCT01647451|"     This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease     activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to     placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX)     therapy.   "
125152|NCT01647438|"     Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the     feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle     intervention to improve the cardiovascular health of underserved South Asian (Indian,     Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be     randomly assigned to either a group to receive heart disease prevention classes or to another     group where they will receive written materials about heart disease prevention.   "
125153|NCT01647425|"     This is an multicenter study for preventive and therapeutic strategies for patients with head     and neck cancer   "
125154|NCT01647412|"     Of the estimated one million Americans with inflammatory bowel disease (IBD), approximately     20-30% develop this condition during childhood or adolescence, most of whom have Crohn's     disease (CD). It appears that some individuals are genetically susceptible to certain     nutrients, causing inflammation and disturbance of their immune system, as well as disruption     of the intestinal barrier. This leads to malnutrition and inhibited growth, with many     patients experiencing intense abdominal pain and diarrhea.      Most physicians treat the disease with drugs that suppress the immune system and decrease the     inflammatory process. Although these drugs frequently induce remission, most patients     experience a subsequent return of symptoms and fail to catch up on their growth.     Additionally, serious side effects are associated with these drugs.      Individuals genetically prone to CD are believed to have a leaky gut that allows substances     to pass through the intestinal wall and react with the underlying immune system. Furthermore,     those nutrients that are toxic to these individuals pass through the decreased intestinal     barrier triggering an extreme immune response. Nutrients that have been implicated include     grains, except rice, dairy products, and any food containing carrageenan. Excluding these     nutrients from the diet has been shown to beneficial for CD patients. Certain nutraceuticals,     such as curcumin and omega-3 fatty acids, have been shown to provide anti-inflammatory     effects in IBD patients. In addition, the administration growth hormone (GH), has been shown     to alleviate symptoms, by enhancing the repair of the intestinal epithelium, preventing toxic     antigens from reaching the underlying lamina propria.      Previous studies and case reports provide incomplete evidence that exclusion diet with     nutraceuticals (DNT) and GH lead to sustained long term remission in juvenile CD,     discontinuation of other CD drugs, and catch up growth. This study is designed to test this     hypothesis. Patients in the treatment group will be treated with DNT and GH, while continuing     to receive medications from their physician while the control group will receive DNT, placebo     injections instead of GH. We predict that the treatment group will show greater improvement     than the control group.   "
125155|NCT01647399|"     Asthma has become considerably more prevalent and severe in the U.S. during the last 40     years, particularly affecting youth in urban areas, yet the reasons for this are not clear.     There is increasing evidence that vitamin D insufficiency contributes to more severe asthma     through increased risk of respiratory infections and decreased sensitivity to     glucocorticoids. Indeed, low vitamin D levels are linked with the need for exogenous     glucocorticoids and increased asthma severity. Particularly relevant to health disparities,     we showed a strong association between vitamin D insufficiency and asthma in urban African     American (AA) youth. Importantly, AA youth in ours and other studies had lower vitamin D     levels than non-AA participants.      Because AA youth residing in urban Washington, DC have markedly worse asthma than other     racial/ethnic groups (e.g. prevalence rate 20% higher than the national rate 15 and emergency     department utilization rates up to 5 times the national rates and nearly 10 times the Healthy     People 2010 target rate), we will utilize our access to this population at the extreme of     asthma disparities to examine the contribution of vitamin D to disparities in the chronic     control and acute severity of asthma. The overall goal of this study is to provide critical     epidemiological/molecular information that will inform the interpretation of ongoing and     impending randomized clinical trials of vitamin D supplementation in asthma, especially with     regard to urban AA youth with asthma. We hypothesize that low serum 25-hydroxyvitamin D     [25(OH)D] levels are associated with poor chronic asthma control, worse acute asthma     severity, and glucocorticoid insensitivity. The knowledge generated by the experiments in     this application will be crucial to translation of this inexpensive, easily-accessible, and     thereby potentially disparity-reducing prospective therapy for asthma.   "
125193|NCT01646619|"     The purpose of this study is to assess whether the addition of a drug such as Magnesium     sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated     at birth provides additional benefit to the babies' survival and outcome compared to cooling     alone.   "
125273|NCT01645358|"     Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation     (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic     Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory     failure, it is largely employed as a rotating strategy when the facial mask is poorly     tolerated.      In a multicenter randomized controlled trial, the investigators will compare the clinical     efficacy of a new helmet designed to specifically improve the performance in chronic     obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.   "
125156|NCT01647386|"     Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest     among surgeons to quantify the effectiveness of specific implant designs, the goal of the     current project is to use Radiostereometric Analysis (RSA) to provide conclusive and     clinically relevant results on fixation of the tibial component with the DePuy M.B.T.     Revision TKA system using Metaphyseal Sleeves.      Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to the     underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The maximum     total point motion (MTPM) value of migration of the M.B.T. Revision Knee System component     between postoperative years one and two does not exceed 0.2 mm indicating adequate long-term     fixation at the bone-implant interface.      • Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System     component between postoperative years one and two does exceed 0.2 mm indicating inadequate     long-term fixation at the bone-implant interface.      b) In what proportion of patients is adequate fixation achieved?   "
125157|NCT01647373|"     All existing medical literatue regarding axial length (AL) changes after scleral buckling     surgery for retinal detachment, descibes changes after solid silicone buckling. In this     hospital, the investigators use only silicone sponge buckling, which has different properties     and a different buckle profile. there are no studies in the literature describing tha AL     changes after sponge buckling, or whether the AL change is less or more than with solid     silicone buckles. The investigators wish to determine whether the AL change profile with     their silicone sponge is significantly different, and if so, whether this is clinically     important in determining the better choice of buckle material to be preferred.   "
125158|NCT01647360|"     Dydrogesterone is a retroprogesterone with a molecular structure similar to natural     progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low     antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic     activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.      In this study, women suffering from menorrhagia and who are treated with dydrogesterone will     be observed for impact on QoL with the reduction in severity of bleeding.   "
125159|NCT01647347|"     The study investigates the effect of supra- and subgingival rinsing of 10% PVP prior to     ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in     terms of post treatment bacteraemia.      Study design: Randomized split-mouth (cross-over) study on 20 generally healthy subjects.   "
125160|NCT01647334|"     This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent     treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too     large for standard curative treatment. The study will use adaptive radiotherapy to achieve     these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during     the course of treatment due to patient and tumor variations (ie. weight loss or tumor     shrinkage). This may allow for dose escalation, while limiting the side effects.   "
125162|NCT01647308|"     The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride     Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment with     metformin.   "
125163|NCT01647295|"     The primary objective of this work will first to characterize in typical childhood, visual     exploratory behavior and pupillary response associated with salience of human social stimuli     (faces and body movements), and then to evaluate these markers in children with autism.      The second objective of this work will be to achieve in a population of children with autism     a longitudinal evaluation of these markers during development and therapeutics.   "
125165|NCT01647269|"     The purpose of this study is to investigate whether deep brain stimulation (DBS) of the     globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and     whether this treatment has any influence on social, psychological and behavioral disability     and quality of life.   "
125166|NCT01647256|"     The primary purpose of this study is to evaluate if eating a high fat meal versus not eating     any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second     purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.   "
125167|NCT01647243|"     The purpose of this study is to investigate if preoperative strength training will result in     faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).   "
125168|NCT01647230|"     The aim of this study is to observe how the hemodynamic changes induced by spinal blockade     affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent     during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting     cardiac output and cerebral blood flow. These complications of spinal anaesthesia could     decline cognitive function. In this way a non invasive monitoring technique as cerebral     oximetry is useful for the safety of anesthetic procedure.   "
125169|NCT01647217|"     This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol     (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis     (reducing ocular demodex counts and achieving the clinical improvement with minimal or no     irritation).   "
125170|NCT01647204|"     The primary objective of the study is to determine if the use of volunteers employed     specifically to focus on mealtime assistance can increase food and nutrient intake of     patients admitted to an acute Care of the Elderly ward. The sustainability of providing     helpers to increase dietary intake over a year will be assessed and linked to actual dietary     intake. The secondary objectives are to assess the association between dietary intake     resulting from mealtime assistance and patient satisfaction, malnutrition risk, body     composition, grip strength, length of hospital stay and hospital mortality.   "
125171|NCT01647191|"     The proposed study will investigate the knowledge level, attitudes, and perceptions among     staff of Methadone Maintenance Treatment (MMT) clinics and intravenous drug users (IDUs) who     attending MMT clinics, which is the most reachable population for HCV/HIV intervention in     China. This study will also explore the barriers that prevent IDUs from getting HCV/HIV     intervention/prevention and medical care services. This study will help to understand and     address this important problem in China and other Asian countries.   "
125172|NCT01647178|"     The proposed trial is to evaluate the use of the TORQ closure assistance device and how it     affects pain in the sternum, breathing and quality of life compared to traditional use of     needle drivers or similar to close sternal wires.   "
125173|NCT01647165|"     Background: Bortezomib is a drug approved by the Food and Drug Administration (FDA) to treat     patients with multiple myeloma. It is given by intravenous injection. Lenalidomide is a drug     that alters the immune system. It may also help suppress tumor growth. It is approved by the     FDA to treat some types of blood cancers. Dexamethasone prevents or treats inflammation. It     is sometimes used to treat multiple myeloma.      Objectives: The purpose of this study examine how the combination of the study drugs affects     myeloma.      Eligibility:        -  Participants at least 18 years old who have multiple myeloma that has come back, did not          respond to treatment, or worsened while being treated.        -  Participants who may be pregnant will be tested to ensure that they are not pregnant.      Design:        -  Participants will be screened with a history and physical examination. Blood work and          urine samples will be taken. A series of x-rays of all bones will be done. A bone marrow          biopsy will be done.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Treatment will continue as long as the cancer does not grow or spread and no serious          side effects develop.        -  There will be up to eight 21-day treatment cycles.        -  Bortezomib is given by subcutaneous (under the skin) (SC) injection on days 1, 4, 8, and          11 of the cycle.        -  Lenalidomide is given by mouth on days 1 14 of the cycle.        -  Dexamethasone is given by mouth on days 1, 2, 4, 5, 8, 9, 11, and 12 of the cycle.        -  Following cycle eight, if the disease is stable or better, participants will receive          bortezomib SC at the dose given at the end of cycle eight.        -  Participants will take valacyclovir or acyclovir while taking bortezomib to prevent          virus infections.   "
125174|NCT01647152|"     Background:      - Uveitis is an eye inflammation that can cause vision loss. It is treated with eye drops,     drugs and sometimes surgery. In some people, treatment may not prevent vision loss. A type of     white blood cells called T-cells often have a role in causing uveitis. In some cases of     uveitis, T-cells attack the eye and cause inflammation. A drug called ustekinumab reduces     inflammation from these T-cells. Researchers want to see if ustekinumab can be used to treat     uveitis.      Objectives:      - To see if ustekinumab can be used to treat uveitis.      Eligibility:      - Individuals at least 18 years of age who have active uveitis that needs treatment.      Design:        -  Participants will be screened with a physical exam, eye exam, and medical history. Blood          and urine samples will be taken.        -  Participants will have at least eight clinic visits during the 64-week study period.          After the first visit, visits will occur at 2, 4, and 8 weeks, and then every 12 weeks.        -  Participants will have a ustekinumab injection at the first study visit. They will have          additional doses at the second and third visits, and then every 12 weeks until 1 year          after the first dose (Week 52).        -  Treatment will be monitored with frequent blood tests and eye exams. Other standard          treatments for uveitis may be given as needed.        -  There will be a final study visit 3 months after the last injection.   "
125207|NCT01646437|"     The randomized 2x2x2 factorial design placebo controlled trial will enroll 5000 participants     (women 60 years or older and men 55 years or older) without known heart disease or prior     stroke and without a clear indication or contraindication to any of the study medications.     Eligible and consenting individuals will be randomized to receive either the active study     medications or placebo (dummy pills) and will be monitored for an average of 5 years. The     study will include people from at 10 countries, will be conducted by an international group     of scientists and physicians and will be coordinated by the Population Health Research     Institute at Hamilton Health Sciences.   "
125175|NCT01646866|"     Rationale: Autism Spectrum Disorder (ASD) is defined by deficits in social interaction and     communication identified before the age of 3 years. Modified Checklist for Autism in Toddlers     (M-CHAT) is a sensitive tool for ASD screening in children 16-23 months. A limited number of     studies with a small number of patients have documented the developmental profile of children     with ASD during infancy. Retrospective evaluations of videotaped behavior of children with     ASD at 8 months and at 12 months identified early signs of ASD. A few studies found early     signs of ASD during infancy in siblings of autistic children. Data documenting the age of     onset and regression in ASD is controversial and limited. No large prospective studies     documented the specific developmental profile of children with ASD starting at 6 months of     age. Defining a specific autistic pattern on a developmental screening test could help     identify infants at risk for ASD and improve their outcome through earlier diagnosis and     treatment. More recently, genetic tests have been shown to aid in early identification of ASD     which facilitates earlier intervention. Genetic testing among siblings of children with     autism can aid in identification of autism or other related disorders in the siblings.      PURPOSE: The purpose of this study is to learn about the early signs of autism in siblings of     children with autism spectrum disorders.        -  The investigators will enroll siblings of children with ASD. Those siblings who          completed the Red Flags for Communication scale (RFC) at 6 months and/or at 12 months          and failed the RFC at 12 months will be given a genetic screening test.        -  It is the investigators goal to define a specific autistic pattern on a developmental          screening test that could help identify sibling infants at risk for ASD and improve          their outcome through earlier diagnosis and treatment and to evaluate if the results of          the clinical screening test will correlate with the results of the genetic screening          test.   "
125176|NCT01646853|"     The objective of this study is to determine the optimal radiation dosage used in concurrent     chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an     initiate dose of 50Gy conventionally applied in Western countries.   "
125177|NCT01646840|"     This study will assess the relative bioavailability of a capsule formulation of PF-04958242,     relative to a oral solution formulation of PF-04958242 in healthy adult subjects.   "
125178|NCT01646827|"     The purpose of this study is to determine whether aripiprazole injection into the shoulder or     the buttocks produces similar effects in the body   "
125179|NCT01646814|"     This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury     after the oral administration of an investigational product, PL2200, and a marketed 325 mg     immediate-release aspirin product. Each group will be treated with either an     immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and     evaluated via an endoscope for any gastrointestinal injury that may have been caused by study     medication.   "
125180|NCT01646801|"     The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's     drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral     arterial disease.   "
125181|NCT01646788|"     The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's     percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of     Arteriovenous (AV) Dialysis Fistulae/Grafts.   "
125200|NCT01646528|"     The study aims to:        1. Explore the properties of mesenchymal black spots, and to determine the value of          mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser          endomicroscopy (CLE).        2. Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in          patients with gastric mesenchymal black spot during CLE imaging.   "
125182|NCT01646775|"     Background: For cancer to grow and metastasize, inflammatory and immunologic conditions in     the host must be favorable. The perioperative period provides inflammatory and immunologic     changes that may be pro-malignant. Anesthetic medications, including the use of opioid     medication, may contribute to these changes.      Hypothesis: The investigators hypothesize that perioperative immunologic changes in patients     undergoing resection of hepatic colorectal cancer recurrence, as measured by natural killer     cell function and cytokine levels, will undergo less alterations in those who receive only     epidural bupivacaine, as compared to those who receive epidural bupivacaine and fentanyl.      Methods: In this double blind control trial patients with no extra-hepatic evidence of     cancer, undergoing a planned curative resection of hepatic recurrence of colorectal cancer,     will be randomized to receive an epidural with bupivacaine and fentanyl, or bupivacaine     alone. No other perioperative opioid medication will be given, and post-operative analgesia     will be supplemented with acetaminophen and gabapentin. Blood samples and pain ratings using     a verbal analogue scale will be obtained preoperatively, immediately and 6 hours     postoperatively, and then daily until removal of the epidural catheter. Samples will be     analyzed for levels of interleukin 2, 6, 8, 10, 12, 16, 17,TNF-α, TGF α and β, MCP-1, CRP,     and NK cell activity. Cytokines will be measured using a suspension bead array immunoassay     kit, and NK activity will be measured using flow cytometry of isolated peripheral blood     mononuclear cells exposed to the K562 cell line and treated with fluorescent antibodies to     intracellular markers of activation. Data will be compared between groups using t-tests, or     Mann-Whitney tests as appropriate. To demonstrate a 50% smaller decrease of NK cell activity     in the bupivacaine group as compared to the bupivacaine and fentanyl group the investigators     will need to randomize a total of 30 patients.   "
125183|NCT01646762|"     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation     works in treating patients with multiple myeloma that has returned or did not respond to     treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of cancer cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading.   "
125184|NCT01646749|"     The purpose of this study is to determine ad libitum daily energy intake, body weight changes     and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive     days, and in relation to age, gender, body mass index (BMI) and fat mass and     obesity-associated (FTO) gene alleles.   "
125185|NCT01646736|"     Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral     T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of     patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical     trial. Observation period of 24 weeks.   "
125186|NCT01646723|"     The objectives of our project are to: 1.) Develop a training program and manual for     volunteers to implement evidence-based, non-pharmacological interventions for     neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and     train volunteers using the VALID program and pilot test the volunteer-led program with 20     individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate     the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's     experience, and LTC staff stress.   "
125187|NCT01646710|"     The study aims to explore ways in which optifood can be developed to create relevant food     based recommendation (FBR) and to used for advocacy purposes.      The optifood tool will be pilot tested with relevant organizations and refine FBRs for the     target population. Its performance will be assessed in the hands of Government/NGOs in Peru,     Thailand and India to provide guidance on incorporating into their advocacy programs.     Qualitative and quantitative methods will be used.   "
125188|NCT01646697|"     This study is being done to investigate another way of evaluating margin status after     pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional     method of surgical pathology   "
125208|NCT01646424|"     The aim of this study is to describe patient preferences on budesonide/formoterol fix dose     combination for the treatment of their COPD, and to find those factors more strongly     associated to a better attitude to medication.   "
125247|NCT01645917|"     The purpose of the study is to determine the permanency of PV isolation with the Arctic Front     Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute     procedural outcomes and measures as well as clinical AF recurrence in these patients     approximately 3 months post-ablation.   "
125189|NCT01646684|"     After failure of initial ADT, addition of an anti-androgen is established to treat castration     resistant prostate cancer (CRPC). Substitution of the first anti-androgen and anti-androgen     withdrawal results in treatment responses in 25-40% of patients for 4-6 months. A more     effective second line treatment after failure of first ADT could prolong the time until the     state of symptomatic HRPC, which is currently treated with docetaxel and accompanied by     significant side effects. Since the importance of the IGF-signaling in PC is not only     indicated by preclinical results but also by clinical efficacy of somatostatin analogs,     further clinical research with the new somatostatin analog pasireotide is warranted.      This study is designed to define the maximum tolerated dose (MTD) of pasireotide LAR in     patients with castration resistant prostate cancer (CRPC). It also aims for a preliminary     efficacy evaluation of pasireotide within the dose expansion part at the MTD. Preliminary     efficacy will be assessed by evaluation of different measures of prostate cancer e.g. changes     in PSA, disease control rate (RECIST 1.1), symptoms and changes of biomarkers linked to the     mode of action of pasireotide LAR. The study will also explore characteristics of patients     who might benefit most from this treatment approach.   "
125190|NCT01646671|"     This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive     Japanese patients   "
125191|NCT01646645|"     The purpose of this study is to see how well transfusions of T-cells work in treating CMV.     T-cells are a type of white blood cell that helps protect the body from infection. A     transfusion is the process by which blood from one person is transferred to the blood of     another. In this case, the T-cells are made from the blood of donors who are immune to CMV.     The T-cells are then grown and taught to attack the CMV virus in a lab.   "
125192|NCT01646632|"     Questions: Does an evidence-based exercise program increase activities of daily living and     physical fitness in institutionalized older adults? Does this program decrease the care     dependency of institutionalized older adults? Design: A randomized control trial using     group-based exercise was performed in 14 assisted-living facilities for the elderly (>70     years old).      Outcome measures: Outcome measures were performance on ADL, physical fitness, and care     dependency measures. The exercise program comprised group-based progressive resistance     training, balance training, and functional training. The control intervention comprised     social group meetings.   "
125201|NCT01646515|"     The purpose of this study is to determine if udenafil improves exercise tolerance in patients     with systolic heart failure.   "
125194|NCT01646606|"     In infants hospitalized with bronchiolitis, a common infection in the lungs caused by a     virus, it is uncertain on how to best monitor their oxygen levels. It is common to place a     probe on infants hands or legs to monitor oxygen levels. The probe can be used to monitor     oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours     (intermittent oxygen monitoring). There is reason to believe that placing children with     bronchiolitis on continuous monitoring might result in children staying longer in hospital     than needed. This is a research study that is aiming to provide data to plan a larger     research study to answer the question of whether intermittent oxygen monitoring is better     than continuous oxygen monitoring. This study is part of a larger initiative to determine the     best way to care for children with bronchiolitis, including making sure that children do not     stay in hospital longer than needed.      Parents will be asked to participate in this research study if their child is hospitalized     with bronchiolitis and has been stable for at least 6 hours, meaning that he/she is not     having more trouble breathing or does not require more supplemental oxygen. If they agree     participate, the child will have one of the two oxygen monitoring strategies: intermittent or     continuous monitoring. Each child will have an equal chance of getting one or the other of     these two monitoring strategies.      The study team will review the children's charts to determine the number of tests ordered,     the need for intensive care unit help or admissions, the number of blood tests and chest     x-rays the treating doctors ordered, and the length of hospital stay. Parents will be     contacted about 4-5 days after discharge to ask if there were any unscheduled visits to     doctors or emergency rooms after discharge. The investigators will the parents to fill out a     scale twice a day asking how well their child is feeding. The investigators will also them to     rate their anxiety level once a day.      The information from this study will help plan and support an application for external     funding. The results of a larger study could potentially decrease unnecessary monitoring,     oxygen supplementation, and hospital stay and thereby improve quality of care with large cost     savings. A reduction in length of hospital stay for this common hospital condition would also     reduce the burden of hospitalization to families and reduce the risks associated with harm in     the hospital setting such as infection and medical error.   "
125195|NCT01646593|"     The objective of the trial is to provide regorafenib to subjects diagnosed with metastatic     and / or unresectable GIST who have progressed after standard therapy.      Selected additional safety information on regorafenib will be collected and progression-free     survival (PFS) will be estimated.   "
125196|NCT01646580|"     Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug which has shown     activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. Its mechanism of     action is based on a fungicidal activity by inhibiting the cellular captation of essential     substances needed for the metabolism and growth of the fungi. On the other hand, this drug     binds irreversibly with cell structures as mitochondria, ribosomes, microsomes and cell wall.     After dermal application, Ciclopirox olamine undergoes skin penetration, being only absorbed     a 1,5% of the applied dose. Clinical efficacy has been studied in patients above 10 years     with superficial dermatomycoses (dermatophytoses, candidiasis and pityriasis versicolor) and     the percentage of clinical healing ranged from 77% to 91% after 2-4 weeks of twice a day     topical application. In all the studies, the safety profile has been very good, showing only     a very low rate of adverse events of mild to moderate intensity. There are very few previous     available data on the application of this compound in children under 10 years of age. A     single study had been performed with a solution formulation in patients from 6 to 29 months     with diaper candidiasis, showing good efficacy and tolerability in these patients. The     present study aims to show the safety and tolerability of ciclopirox olamine in a cream     formulation in patients from 3 months to 10 years with dermatomycoses.   "
125197|NCT01646567|"     The purpose of this study is to assess the safety, tolerability and clinical activity of the     SHP-141C topical cream formulations in patients with plaque type psoriasis.   "
125209|NCT01646411|"     For the development of a Point of Care IVD test kit for acute phase disease detection against     a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed     positive and 200 clinically normal serum and whole blood matched specimens for specificity     and sensitivity determination for each marker. The positive samples must be IgM positive     using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.   "
125210|NCT01646398|"     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a     single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of     23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.   "
125198|NCT01646554|"     Patients presenting with multiple innumerable liver metastases will probably never come to     resection, however, for all others, including patients with numerous multiple metastases or     large metastases, resection should be considered after limited chemotherapy.      There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin.     FOLFOX was used in the previous EORTC study and is again recommended.      The addition of targeted agents to standard chemotherapy in the perioperative strategy for     mCRC might increase the ORR and R0 resectability, without significant increase in toxicity,     therefore translating to a better outcome.      BOS2 (EORTC 40091) was designed to test this hypothesis in patients with a KRAS wold-type     profile.      It was decided in parallel to design an open label, randomized, multi-center, 2-arm phase     II-III study this time aimed at enrolling KRAS mutated patients.      Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Aflibercept + Surgery   "
125199|NCT01646541|"     Most patients with mitral valve disease are symptomatic with shortness of breath and a     limited activity level prior to mitral valve surgery. Despite surgical repair or replacement     of the mitral valve, many patients remain symptomatic with an impaired ability to live an     active lifestyle. Often after extensive evaluation, no other pulmonary, left ventricular     dysfunction, or valvular heart disease is responsible for the continued symptoms, and some of     these patients will be limited by persistent pulmonary hypertension (PH) at rest or with     exertion that is responsible for limiting their activity level and impacting their quality of     their life.      It is our goal in the proposed study to systematically characterize symptomatic and     asymptomatic patients greater than six months after mitral valve surgery using clinical data,     echocardiographic evaluation, laboratory assessment, and in some patients, invasive     hemodynamic measurements. The investigators will screen asymptomatic and symptomatic patients     with resting echocardiography and also with echocardiography during exercise, as many     patients will exhibit exercise-induced PH following mitral valve surgery. Pulmonary artery     (PA) pressure will be estimated from echocardiography using Doppler-derived calculations. If     elevated PA pressures are observed with echocardiography, then symptomatic patients will     undergo right heart catheterization for invasive pressure measurement, which is the     gold-standard for the diagnosis of PH. When PH is present and there is a normal wedge     pressure (PCWP) during invasive pressure measurement, further assessment to identify     potential candidates for PH therapy will be performed. This involves having patients breathe     inhaled nitric oxide, a rapid-acting, pulmonary vasodilator with a short half-life. While     breathing inhaled nitric oxide, blood pressure, PA pressure, PCWP, and cardiac output will be     monitored to characterize individuals who could benefit symptomatically from pharmacotherapy     to treat underlying PH. It is important to note that only a small minority of patients     exhibit a positive vasodilator response and those with PH and a normal PCWP without an     initial vasodilator response would still be identified as candidates for chronic PH therapy.      The information generated from this proposed research will make a significant contribution to     the understanding of PH in a group of patients in whom it has not been previously studied.     Scientific reports on the evaluation of patients with PH after mitral valve surgery are     almost nonexistent from the modern era. Furthermore, patients with PH due to mitral valve     disease have been excluded from clinical trials of agents currently approved by the U.S. Food     and Drug Administration (FDA) to treat PH. Therefore, this work will carefully characterize     PA pressures in an objective manner in a group of patients following mitral valve surgery who     remain limited with respect to their activity levels. In addition, the investigators will     gain a better understanding of the frequency with which patients have PH and a normal PCWP,     which identifies a cohort of patients who could have an improvement in their symptoms and     quality of life with chronic vasodilator treatment.   "
125228|NCT01646164|"     Dill is herbaceous and aromatic herb used in order to convenient and shorter labor in Iran.     The objective of this study was to evaluate the effect of Dill seed on uterus contractions in     active phase of labor.   "
125202|NCT01646502|"     Chronic wounds cause significant morbidity and cost our healthcare system millions of dollars     each year.Their healing is slowed by biofilms, communities of bacteria surrounded by a     protective layer that stops the immune system and antibiotics from getting close enough to     kill them. The investigators will develop a new strategy to destroy biofilms using a protein     made from bacteria that live on our skin.The Staphylococcus epidermidis Esp protein will be     used to destroy Staphylococcus aureus biofilms, the most common bacterium in chronic wounds.     The investigators hypothesize that the use of the Esp protein will breakdown S. aureus     biofilms, decrease bacterial colonization of chronic wounds and improve healing times.   "
125203|NCT01646489|"     The purpose of this study is to assess the safety, tolerability, and affect on blood levels     of miravirsen and telaprevir when administered together.   "
125204|NCT01646476|"     Malignant gastric outlet obstruction can result from gastric adenocarcinoma, leading to     intractable vomiting, nausea, and poor oral food intake. Although self-expandable metallic     stent (SEMS) insertion has excellent technical and clinical success rates for relieving     gastric outlet obstruction symptoms, the uncovered SEMS is susceptible to re-stenosis because     of tumor ingrowth through openings between the stent wire filaments. Therefore, the most     common reason for stent failure in uncovered stents is tumor ingrowth.      The covered SEMS has a membrane that prevents ingrowth through the mesh wall and consequently     shows lower rate of re-stenosis than uncovered SEMS. However, covered SEMS has a higher risk     of stent migration compared to uncovered SEMS. Recent prospective, randomized study showed     that there was no significant difference between uncovered and covered SEMS in terms of stent     patency rate as well as technical and clinical success rates.      Recently the investigators developed new covered SEMS for gastric outlet obstruction. This     new covered SEMS has features that may contribute to reducing migration rate: 1) partially     covered design; 2)less radial force in central portion of stent; 3) presence of lasso which     enable position of stent to be adjusted after deployment; 4)presence of protrusion in both     sides of stent. This prospective, randomized study aimed to compare the effectiveness and     side effects of newly developed covered SEMS with those of uncovered SEMS in patients with     malignant gastric outlet obstruction from gastric cancer.   "
125205|NCT01646463|"     In the U.S., rates of preterm birth and low birth weight have increased over the past 30     years. Poor birth outcomes are especially high among racial/ethnic minority populations.     Maternal stress is an important factor that can lead to negative birth outcomes. Thus,     programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work     tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot     study had lower stress and improved coping after the program. For the current study,     mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy     (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a     version of CP infused with mindfulness skills training. Effects of the two versions of CP on     psychological stress and coping, stress hormones, and birth outcomes will be tested. Data     will be collected from participants three times: twice during pregnancy and once after birth.     Medical records will provide data on birth outcomes and other health factors. The study will     provide initial information about a mind-body program to reduce stress and improve birth     outcomes. Data from the study will inform the development of an R01 proposal for a larger     study. The study will also help advance the long term goal of reducing health disparities.   "
125211|NCT01646385|"     This study will assess the rates of serious adverse events and death in adult rheumatoid     arthritis patients treated with etanercept over the long-term in real-life clinical practice.     It will also assess whether there is any difference in the rate of serious adverse events in     patients trated with etanercept in comparision to patients treated with conventional     disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the     efficacy of etanercept in this population by assessing the rates of important clinical     outcomes such as changes in disease activity and disability/functioning.   "
125212|NCT01646372|"     The purpose of this study is to investigate whether formal instruction on the use of     cognitive aids in managing a crisis will result in better longterm retention of knowledge and     skills. In particular, this study examines the impact of cognitive aid teaching on the     Advanced Cardiac Life Support course.   "
125213|NCT01646359|"     In patients under mechanical ventilation, Usefulness of dynamic indices based on the     heart-lung interactions for guiding volume resuscitation has been well validated. Recently,     validity of pulse pressure variation (PPV) has been also reported to predict fluid     responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important     hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated and     used as a preload index, and has been reported to predict fluid responsiveness. Prone     position caused physiologic and hemodynamic changes and influenced the predictability and     cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled study,     the investigators evaluated the validity of PPV and FTc as predictors for fluid     responsiveness in supine and prone position in patients undergoing posterior lumbar spinal     fusion   "
125214|NCT01646346|"     The Purpose of this study is to evaluate the feasibility of using image guidance and     four-dimensional computed tomography to reduce the volume of non target breast tissue that is     treated with accelerated partial breast irradiation via the external beam technique.   "
125229|NCT01646151|"     An observational study comparing changing from an IOP-lowering treatment to a     bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular     hypertension (OHT). Visits and treatment are per normal clinical practice.   "
125257|NCT01645774|"     Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study     aimed to Identify and compare the effects of four different injection duration on pain and     bruising associated with subcutaneous injection of heparin in 90 patients. Four injection     methods were used for them:      A: 10s injections duration      B: 10s injection duration and waiting 10s before withdrawing the needle      C: 15s injection duration and waiting 5s before withdrawing the needle      D: 5s injection duration and waiting 15s before withdrawing the needle.      Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was     measured by pain visual analogue scale immediately after the injection. Data will be analyzed     by SPSS.   "
125274|NCT01645345|"     To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the     treatment of acne scars and wrinkles.   "
125215|NCT01646333|"     This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving     training compared to supportive therapy in individuals with Parkinson's Disease with Mild     Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned     to receive memory and problem solving training or supportive therapy for 2-months. A 6-month     follow up evaluation will establish if benefits remain over time. Impact of these therapies     on thinking abilities, physical health, and patient and support person ratings of thinking     skills, mood and quality of life will be evaluated. The memory and problem solving training     is hypothesized to result in greater improvements and/or stability of function on     neuropsychological tests of attention, working memory, learning, and memory skills compared     to the supportive therapy condition. Both conditions are hypothesized to result in improved     mood and quality of life ratings.      Results from this study will determine whether memory and problem solving therapies and     supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease     and Mild Cognitive Impairment. If positive benefit is observed, information from this study     will be used to further optimize these therapies for larger trials designed to evaluate the     value of the therapies for individuals with Parkinson's Disease and their support persons.   "
125216|NCT01646320|"     The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple     combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes     after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of     this treatment will also be studied.   "
125217|NCT01646307|"     This randomized, open label, parallel-group study is designed to investigate whether     periprocedural intensive statin therapy with atorvastatin versus rosuvastatin administration     before PCI and 30-day continuous intensive treatment is superior to usual care, in terms of     cardiovascular events for Chinese elderly patients.   "
125218|NCT01646294|"     The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed     and eliminated from the body, and how well it is tolerated, when given in three different     tablet formulations (sustained release) once a day with and without food, and to compare the     results with the profile of the YM178 immediate release formulation taken twice daily without     food.   "
125219|NCT01646281|"     Atrial fibrillation (AF) is associated with decreased atrial contractility which is     associated with stroke. Decreased contractility becomes apparent after cardioversion of     atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved     contractility immediately after cardioversion may prevent arrhythmia progression. In     addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to     convert atrial fibrillation to sinus rhythm and at the same time increase atrial     contractility. The latter has not yet been shown in humans and is subject of the present     investigation. Our hypothesis is that in humans the contractility of the atria is higher     after administration of vernakalant compared to flecainide. If indeed vernakalant improves     atrial contractility after cardioversion further studies into the effect on long-term     arrhythmia progression and stroke prevention may follow.   "
125220|NCT01646268|"     The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious     in Chinese subjects with early-stage idiopathic Parkinson's disease.   "
125221|NCT01646255|"     The primary objective of this study was to demonstrate that Rotigotine transdermal patch is     efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an     adjuvant therapy.   "
125222|NCT01646242|"     Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm.     However, complete removal of diminutive polyps is required to prevent tumor recurrence and     development of potential interval cancers. Currently, a variety of polypectomy techniques     such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the     removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there     are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal     of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare     polypectomy with cold forceps polypectomy using double biopsy technique for removal of     diminutive colorectal polyps.   "
125246|NCT01645930|"     The purpose of this Phase 1 study is to characterize the Pharmacokinetic (PK) and     tolerability of Oral IXAZOMIB when administered in combination with lenalidomide and     dexamethasone in adult Asian patients with Relapsed and/or Refractory Multiple Myeloma   "
125223|NCT01646229|"     Septic shock of intra-abdominal origin is likely due to Gram-negative bacteria or mixed     pathogens and associated with high levels of endotoxin. The injury to the endothelium results     in an increase of endothelial permeability, interstitial edema and release of nitric oxide     (NO) that is a very potent vasodilatator. [6] Polymyxins obtained from the Gram-positive     bacterium Bacillus polymyxa are antibiotics known for their ability to bind LPS in the outer     membrane of the Gram-negative bacterial cell wall as well as free endotoxins with high     affinity. Polymyxin-B has been shown to block the activation of cells by a wide variety of     LPS. Studies converged to show an improvement in the treatment of septic shock by removing     circulating endotoxin.Starting Polymyxin-B hemoperfusion during the operative time is to     block the initiation of various deleterious biological cascades induced by endotoxemia such     as systemic inflammation, disseminated coagulation disorders, and shock, leading to organ     dysfunction and death.   "
125224|NCT01646216|"     The purpose of this study is to determine whether split belt or conventional treadmill     training can be used to treat walking pattern deficits from stroke and to determine whether     this improves gait asymmetry and metabolic efficiency.   "
125225|NCT01646203|"     A study to evaluate the safety and tolerability of IMC-TR1 in patients with advanced solid     tumors, as well as gather evidence of anti-tumor activity.   "
125226|NCT01646190|"     Fast-track (FT) surgery is a multimodal, multidisciplinary-team approach to reduce     perioperative surgical stress and injury after colorectal surgery, resulting in lower     morbidity and enhanced recovery. As fast-track approach could probably be the most beneficial     for senior patients to reduce postoperative morbidity and better preserve independency, only     scarce information is available in senior population. Therefore a randomized controlled trial     is initiated in our institution compare a senior dedicated fast-track approach to modern     standard care after colorectal surgery.   "
125227|NCT01646177|"     This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to     etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.   "
125230|NCT01646138|"     Background:      - A challenge study exposes a person to a disease and allows researchers to study the disease     through the body's healing process. An influenza challenge study that looks at different     amounts of the flu virus can provide more information on the smallest amount needed to cause     an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy     volunteers to see how the body responds to the virus.      Objectives:        -  To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate          flu infection in a healthy adult.        -  To study how the body s immune system responds to the virus.      Eligibility:        -  Healthy volunteers at least 18 years of age.        -  Participants must be willing to remain in isolation for a minimum of 9 days.      Design:        -  Participants will be admitted to a hospital inpatient isolation unit. They will be          screened with a physical exam and medical history. They will also have heart and lung          function tests. Blood, urine, and nasal swab/wash samples will be collected.        -  Participants will receive a single nasal spray of the flu virus. They will stay on the          inpatient unit for at least 9 days.        -  Participants will be monitored for the length of their stay. They will have frequent          blood tests and other procedures as needed.        -  Participants will be allowed to go home once they have had two negative tests for the          virus. The tests will be given on two consecutive days....   "
125231|NCT01646125|"     The purpose of this study was to determine if AUY922 had superior efficacy when compared to     chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.      The primary purpose of this study was to compare the efficacy of AUY922, when administered     i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients     with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed     resistance to EGFR TKI.   "
125232|NCT01646112|"     Background:        -  Individuals have varying tolerances for receiving ambiguous information. However, not          much is known about how ambiguous genetic testing information is received. Also, not          much is known about how at-risk individuals internalize and process these results. More          information is needed about how this information affects a person s life.        -  Lynch Syndrome is a genetic condition that carries a high risk of colon cancer and other          cancers. Individuals at risk for Lynch Syndrome can have genetic testing for it. The          test may confirm a diagnosis and determine actions that can be taken. Results from          genetic testing can also affect the perspectives of relatives who might also be          affected. However, genetic testing can also produce variants of unknown significance          (VUS). VUS are data that may not provide enough information to make decisions.          Researchers want to study people who have received a VUS result for genetic testing for          Lynch Syndrome.      Objectives:      - To learn more about the impact and experience of receiving a VUS for Lynch Syndrome genetic     testing.      Eligibility:      - Individuals at least 18 years of age who have recently had a VUS result on a genetic test     for Lynch Syndrome.      Design:        -  Participants will be asked to answer demographic questions. They will also have a 45- to          60-minute phone interview.        -  During the phone interview, participants will be asked a series of questions about their          diagnosis. They will be asked about how they received the result and how they felt right          after receiving it. They will also discuss who they have spoken to about the result.   "
125233|NCT01646099|"     This study is being done to evaluate the effectiveness of a Sun Protection Strategies     internet-based program for kidney transplant recipients. Since the medication taken to     preserve the kidney transplant puts kidney transplant recipients at increased risk of     developing a sunburn as well a skin cancer, the program will help people learn how to     practice effective sun protection for their condition.   "
125248|NCT01645904|"     The goal of this research study is to create an internet-based program designed to improve     the communication of health and health history information among family members affected by     Lynch syndrome.   "
125234|NCT01646086|"     To achieve the long term goal of strengthening behavioral weight loss programs, the purpose     of this project is to test an enhanced, daily weight tracking instruction against the current     standard of care (weekly weight tracking) and an alternative mode of care (no weight     tracking).      The investigators postulate that daily weight tracking will boost ongoing awareness of and     engagement in dietary intake and physical activity monitoring, thus improving weight loss     outcomes. The central hypothesis of the study is that daily weight tracking will improve     weight loss processes and outcomes relative to less frequent weight tracking, without adverse     effects.   "
125235|NCT01646073|"     A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate     to severe plaque psoriasis.   "
125236|NCT01646060|"     Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood     volume and blood loss of a patient during surgery, post operatively and/or in recovery. This     monitoring device will identify baseline blood volume and relative changes in blood volume     using a specific algorithm to compare and review data already monitored during surgery,     displaying blood volume and blood loss in real-time.   "
125237|NCT01646047|"     This study will evaluate the effects of a novel multi-component dietary supplement on the     visual function and retinal structure of patients with diabetes with both no diabetic     retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial and     neither subjects nor examiners will know if any given subject is taking active supplement or     placebo.      The hypothesis is that the supplement will improve visual function and retinal structure in     subjects on active supplement   "
125238|NCT01646034|"     This study investigates the effect of high-dose alkylating chemotherapy compared with     standard chemotherapy as part of a multimodality treatment approach in patients with     oligo-metastatic breast cancer harboring homologous recombination deficiency.   "
125239|NCT01646021|"     The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus     temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at     least 1 prior chemotherapy regimen.   "
125240|NCT01646008|"     The purpose of this study is to study the correlation between carbon dioxide measured by     capnography at the enf of exhalation and arterial blood in COPD patients with nasal cannula     in critical care unit.   "
125252|NCT01645852|"     The purpose of this study is to measure the effect of a short-term low calorie diet on     patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.   "
125241|NCT01645995|"     Specific policies on obesity reduction often include a recommendation to reduce sugar     consumption as a means of lowering overall caloric intake. Reformulating processed foods     (e.g. sugary products) is considered one of the key options for improving population diet.     The implications of regular consumption of reformulated products are not fully understood.     Previous studies have demonstrated that dietary compensation is common, although the extent     is not fully elucidated. In addition to the perceived impact of sugar consumption on weight     control, high sugar intake, specifically sucrose and fructose, has been implicated in the     increase of plasma lipids and markers of insulin resistance. However to date no randomised     controlled study has investigated whether the consumption of reformulated low sugar products     as components of a habitual diet have a significant impact on plasma lipid, insulin or     glucose concentrations within a free-living, non-diseased population. It is hypothesised that     exchange of reformulated, low sugar food products for habitually consumed foods will result     in dietary compensation and minimal weight change compared with unmodified products and will     have little impact on plasma glucose, insulin and lipid levels.   "
125242|NCT01645982|"     The purpose of this study is to compare the changes measured by Somanetics Invos cerebral     oximeter to the mean arterial pressure at brain level in patients having elective shoulder     replacement surgery. The Somanetics Invos System measures and monitors the oxygen saturation     (rS02) of blood in the brain tissues to help prevent brain injury or other complications. The     investigators hypothesize that maintaining normocarbia and systemic mean arterial pressure at     or above 70mmHg during general anesthesia in the beach chair position will decrease the     number of cerebral deoxygenation events during the procedure.   "
125243|NCT01645969|"     This multicenter, prospective, observational study will evaluate the one-year outcomes in     HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a)     in Arm A of study ML22265. Data will be collected from each patient for up to one year     post-therapy.   "
125244|NCT01645956|"     The importance of exercise for weight control is well documented; however if exercise results     in an increase in food intake, the beneficial effect of exercise may not be seen. This study     addresses a gap in the current literature and examines why some people eat more after     exercise and why some people eat less and also examines whether these responses are     consistent over time. Participants in this study will be asked to come to our center on 7     different occasions over a 3-4 month period. The first visit will be an assessment visit     where body weight and body composition will be measured, questionnaires will be completed,     and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions     with visits in each pair separated by 48-96 hours) the procedures will be nearly identical.     Upon arrival at our center, participants will consume a meal replacement, complete a series     of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be     resting and 3 will be exercising). One hour following the exercise/resting session,     individuals will be given access to a buffet of food, unaware that their food intake will be     monitored. All food will be weighed and measured before and after the eating period and the     amount of food consumed after each pair of exercise and resting conditions will be compared     to one another. It is hypothesized that the difference in food intake will be consistent     across pairs of testing sessions. Findings from this study will help us to better understand     the relationship between exercise and food intake and may ultimately lead to future studies     that can address the clinically significant question of why some individuals gain weight and     others lose weight when engaging in exercise training programs. Findings from this study may     also help to develop exercise programs that maximize the beneficial effect of exercise on     body weight.   "
125245|NCT01645943|"     The guidelines of clinical practice, based on the randomized studies, recommend an invasive     strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with     comorbidities are excluded from the randomized studies and the observational registries     showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to     investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities.      Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities,     will be included. The latter will be defined as at least 2 of the following: peripheral     artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal     failure and anemia. The included patients will be randomized to an invasive (routine coronary     angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia)     strategy. All patients will receive medical treatment according to current recommendations.      The main outcome will be death, reinfarction or readmissions by heart cause at one-year     follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients     with NSTEACS and comorbidities.   "
125249|NCT01645891|"     The purpose of this study is to evaluate the safety and effectiveness of Continuous Diffusion     of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary objective of     this study is to evaluate the effectiveness of CDO in combination with standard moist wound     therapy (MWT) on wound healing as compared to standard MWT alone.   "
125250|NCT01645878|"     Exclusive breastfeeding is very important for an infant's growth and development.     Self-efficacy is a modifiable psychological variable in sustained breastfeeding that is     defined as a mother's confidence in her perceived ability about successful exclusive     breastfeeding. Self- efficacy beliefs function as an important set of human motivation ,     affect , and action which operate on action, through motivation, cognitive and affective     interventing process. teaching strategies ,based on Bandura,s self-efficacy theory and adult     learning principles were incorporated in this research design. In regards with the importance     of education in increasing breastfeeding self-efficacy and exclusive breastfeeding, the     current study was conducted in order to compare of the effectiveness of two educational     methods, i.e., Hands on and Hands off on breastfeeding self-efficacy in primiparous     mothers.      In the present clinical trial, 136 nursing mother were randomly assigned to one of the three     groups. Participants in the experimental groups received one of the structured one-on-one     educational sessions (i.e., hands off or hands on) within the first two hours of giving     birth. Mothers in control group received usual postpartum care. Follow-up assessments were     conducted one, four, and eight weeks after the birth. Data collection was done through     interview forms, examination and observation, checklist of breastfeeding status,     breastfeeding self-efficacy and daily-feeding form.   "
125251|NCT01645865|"     Although gains have been made in achieving the health-related Millennium Development Goals     (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of     mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality     from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health     facilities randomized to two arms (intervention or control) to determine the effect of mobile     phone technology on completion of key PMTCT milestones from antenatal to six weeks     postpartum. The study will examine the acceptability, effectiveness, and cost of implementing     a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health workers, and male     partners.   "
125261|NCT01645722|"     The objective of this pilot study is to assess the efficacy of minimally invasive autologous     fat transfers at the amputation sites and the modulation of pain at the respective sites. Our     investigators hypothesize that autologous fat grafting can provide a minimally invasive     therapy to effectively mitigate pain syndromes at amputation sites, by introducing volume     stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby     avoiding major surgical revisions and preserving limb length. The investigators further     hypothesize that enriching the fat graft with autologous adipose stromal cells, a     regenerative medicine approach, will lead to improved retention of the fat graft over time     and result in a more favorable outcome.      The Investigators will evaluate:        1. Treatment of painful amputation sites in 5 patients with fat grafting, intended to          provide additional subcutaneous tissue padding over bony structures and nerve trunks.          Limb anatomy and healing of the graft over time, along with stability/persistence of the          new tissue, will be assessed by high resolution CT scanning with 3D reconstruction.          Patients will be followed for 24 months after treatment to define long term outcomes.          Patients will be enrolled who have pain at an amputation site that limits function          and/or interferes with the ability to use a prosthesis.        2. Biologic properties of the cells within the fat graft and correlate with clinical          outcomes. This will include adipose stem cell yield per volume of fat tissue, cell          proliferation, capacity for adipogenic differentiation, lipolysis, and cell          sub-population analysis by multiparameter flow cytometry. Results of these assays will          be correlated with graft volume retention to search for predictors of good clinical          outcome that are related to variation on adipose biology between subjects.        3. Quality of life measurements in patients before and after autologous fat grafting using          validated psychosocial measures. This will include SF 36, the Beck inventory, and          instruments designed for assessing limb function.   "
126189|NCT01633359|"     Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in     coronary artery disease (CAD) patients from those without CAD, which might account for the     benefits of Atorvastatin in CAD patients.   "
125262|NCT01645709|"     This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the     safety, tolerability, and efficacy of Intra-Articular (IA) verapamil in the treatment of     joint pain in patients with knee osteoarthritis (OA). Subjects will discontinue all analgesic     medications for the entire duration of the study, except for acetaminophen (taken on an as     needed basis at no more than 2 g/day). At visit 2, subjects who meet all entry criteria will     be randomized to receive a single injection of IA verapamil or IA placebo at a ratio of 1:1.     Treatments will be given with fluoroscopy or ultrasound to confirm needle placement. Subjects     will be monitored for blood pressure and heart rate (sitting and standing) for at least 1     hour post-injection. Subjects will be evaluated at weeks 1, 2, 3, 4, 6, 8, and 12 after     treatment.   "
125263|NCT01645696|"     The purpose of this study is to investigate the accuracy and performance of a new     subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high     blood sugar) and hypoglycemic (low blood sugar) clamp conditions and during meal excursions     over the course of 72 hours as compared to a commercially available monitor.   "
125264|NCT01645566|"     This is a prospective randomized controlled study. The aim of this study is to        1. describe the stress patterns experienced during a CPR situation;        2. investigate whether the perceived stress was associated with CPR performance in terms of          hands-on time and time to start CPR;        3. to investigate whether this task focusing strategy reduces perceived stress levels, and        4. whether this translates into better CPR performance. Based on findings that clear,          directive leadership can enhance performance in cardiac resuscitation, we further 5)          investigate if stress was associated with fewer leadership statements.   "
125265|NCT01645475|"     Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a     mismatch between nocturnal bladder capacity and the amount of urine produced during the night     together with failure of the child to awaken in response to a full bladder.Urine     overproduction at night or nocturnal polyuria (NP) is a major factor contributing to     monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.      Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion,     the synthetic AVP analogue desmopressin is widely used to treat MNE.      It is recommended by the International Consultation on Incontinence (grade A,level 1).     Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest     form melt.      Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity     disorder (ADHD) in children with MNE According to recent data there is a high incidence of     periodic limb movements in sleep at night in children with nocturnal enuresis. Those children     have an increased cortical arousability leading to awakening.      The frequent awakening most likely has an influence on concentration and other ADHD-symptoms     in daily life.      This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms,     cognition and learning, sleep, quality of life and self esteem.      New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and     sleep problems are tested before the start of the study medication desmopressin melt (T1) and     6 months later (T2). It is a multi-method, multi-informant study.   "
125266|NCT01645449|"     The purpose of this study is to compare and evaluate the single-dose oral bioavailability and     to monitor the safety of subjects.   "
125267|NCT01645436|"     The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC)     is to assess the impact of an exercise program intervention in pediatric cancer patients     undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention     will have a beneficial effect on the study outcomes.   "
125268|NCT01645423|"     The purpose of this study is to compare and evaluate the single-dose oral bioavailability and     to monitor the safety of subjects.   "
125269|NCT01645410|"     The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg     of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland     Pharmaceuticals in healthy, adult, human subjects under fed condition.   "
125270|NCT01645397|"     The purpose of this study is to assess if in steroid naïve asthmatic children with elevated     baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled     nitric oxide level results in restoration of the bronchodilator response to deep inhalation.   "
125271|NCT01645384|"     The purpose of this study is to monitor clinical status, adverse events and laboratory     investigations and assess relative safety and tolerance of Atorvastatin formulations under     fasting conditions.   "
125272|NCT01645371|"     This qualitative research is to assess the validity of the stool symptom screener that will     be used in patients with chronic opioid-induced constipation to determine the adequacy of     their response to laxatives.   "
125512|NCT01642225|"     Purpose of the study:      The specific aims of this study are to evaluate overall efficacy and safety of the     pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors     affecting treatment outcomes in order to improve patient selection and treatment protocols     for future patients.   "
125304|NCT01644955|"     This study is being done to evaluate the toxicity and safety of carboplatin administered by     convection enhanced delivery into the tumor in patients with high grade glial neoplasms. This     study is a dose escalating study, (the dose of the study drug is increased at set time     points). Carboplatin is in a class of drugs known as platinum-containing compounds; it slows     or stops the growth of cancer cells in your body. Convection enhanced delivery involves     placing one or more catheters into the brain and delivering chemotherapy through those     catheters directly into the brain   "
125276|NCT01645319|"     The primary objectives of the study are:        1. To compare the proportion of patients who achieve a successful response to treatment          (reduction in Intraocular Pressure (IOP) of >15%) between patients treated with laser          surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with          patients receiving additional medications, at 1-year post-treatment initiation.        2. To compare the proportion of patients who achieve a successful response to treatment          (reduction in IOP of >15%) between patients treated with other procedures (including          incisional surgery, drainage device procedures, and other glaucoma procedures) with          patients receiving additional medications, at 1-year-post-treatment initiation.      The study is a prospective, observational cohort study and will not provide or recommend any     treatment. Patients who have failed initial medical therapy with two glaucoma medications     will be identified and enrolled at the time of scheduling of a laser surgery procedure or     other procedure such as incisional surgery or drainage device, or initiation of an additional     course of therapy with medication as determined by their physician. This inception cohort of     new initiators of laser surgical treatment, other procedures, or additional medical therapy     will be followed for 12 months. All decisions regarding treatment are solely at the     discretion of the physician in accordance with their usual practice. Enrollment is expected     to begin in February 2011 and continue through 12 months of follow-up after enrollment     targets have been reached.   "
125277|NCT01645306|"     Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks     (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet     monotherapy or monotherapy alone.      Patients receive a single dose of trial medication by intravenous infusion for 20 minutes.     Patients are followed up one and three days after treatment, at 3 months and by a telephone     interview at 12 months.   "
125278|NCT01645293|"     Patients with cutaneous CD30 positive lymphoma will receive systemical and topical treatment     with their own genetically modified T cells. Treatment evaluation consists of assessment of     safety and preliminary evidence of response.   "
125279|NCT01645280|"     The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in     reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA)     despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and     CNTO 1959 in this population.   "
125280|NCT01645267|"     In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected     with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from     the iliac crest to support the osteotomy. In the planned study a group of children will be     operated with an artificial bone graft material and thus avoiding the need harvesting of bone     graft at the iliac crest.   "
125281|NCT01645254|"     The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the     decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.   "
125282|NCT01645241|"     The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in     oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes     donors . This study will be performed in egg recipients and donors but this type of treatment     is meant to be implemented in fertility preservation patients   "
125283|NCT01645228|"     To validate the capability of non-invasive bio-image tests in prediction of significant     coronary stenosis of symptomatic adults.   "
125284|NCT01645215|"     Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular     endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent     inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted     to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the     pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at single doses and     multiple doses .   "
125285|NCT01645202|"     A randomized controlled multicenter study comparing the acute hemodynamic performance of the     Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk     patients with severe symptomatic aortic stenosis.   "
125286|NCT01645189|"     The objective of this study is to determine the safety and efficacy of once weekly dosing of     idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome     patients < 6 years old.   "
125287|NCT01645176|"     The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is     to learn about the effects in inflammation and pain in patients with Osteoarthritis of the     knee. These medications are FDA approved and commercially available.   "
125288|NCT01645163|"     The study aims to develop, design pilot a mHealth intervention strengthen complementary     feeding (CF) components of the ICDS program.      The methods will include explaining views of caregivers of infants aged 9-11 months, AWWs and     other ICDS personnel on the feasibility, acceptability and the best means of using mobile     phones to deliver CF counselling. Based on the feedback an intervention will be developed and     pilot tested.   "
125289|NCT01645150|"     The purpose of this pilot study is to determine the effects of a 12-week resistance training     program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor     (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can     be reduced by exercise training in this population which leads to an improved treatment     completion rate.   "
125313|NCT01644838|"     It is always considered to shorten the duration of delivery without compromising the mother     and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research     is very limited, with conflicting results regarding the efficacy of these two drugs. So the     investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on     length of active phase of the first stage of labor.   "
125513|NCT01642212|"     This is a clinical trial to test an experimental drug for the treatment of Eosinophilic     Esophagitis (EoE)   "
125290|NCT01645137|"     The use of complementary and alternative medicine in neonatal ward has been steadily rising     during the last decade. This integrated medicine approach has been shown to be helpful to     improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to     premature infants to reduce the length of stay and to cope with clinical complications.     Results from previous studies documented the positive association between OMT and shorter     period of hospitalisation as well as improvement of clinical conditions. The aim of this     nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in     premature infants across 3 neonatal intensive care units (NICU).   "
125305|NCT01644942|"     The study aims to determine in obese patients the implication of intramuscular lipid     accumulation in relation with insulin resistance and defect in lipid oxidation.   "
126190|NCT01633346|"     The purpose of this study is to know the level of expression and activation state of     different transcription factors of the STAT family (STAT1, STAT3, STAT5A, STAT5B, STAT6) in     the hematopoietic cells from tocilizumab treated patients.   "
125291|NCT01645124|"     CYTO-PV is a phase III Prospective, Randomized, Open-label, with Blinded Endpoint evaluation     (PROBE), multi-center, clinical trial in patients with diagnosis of Polycythemia vera (PV)     treated at the best of recommended therapies (e.g.adequate control of standard cardiovascular     risk factors). Irrespective of randomized interventions, all patients will be administered     low-dose aspirin (when not contraindicated), i.e.the standard antithrombotic treatment in PV     patients.      The purpose of this study to demonstrate that a more intensive cytoreductive therapy, plus     low-dose aspirin when not contraindicated, with phlebotomy and/or hydroxyurea (HU), aimed at     maintaining hematocrit (HCT) < 45% is more effective than a less intensive cytoreduction     (either with phlebotomy or HU plus low-dose aspirin when not contraindicated) maintaining HCT     in the range of 45-50% in the reduction of CV deaths plus thrombotic events (stroke, acute     coronary syndrome [ACS], transient ischemic attack [TIA], pulmonary embolism [PE], splanchnic     thrombosis, deep vein thrombosis [DVT], and any other clinically relevant thrombotic event),     in patients with Polycythemia Vera treated at the best of recommended therapies (e.g.     adequate control of standard cardiovascular risk factors).   "
125292|NCT01645111|"     The current study would prospectively evaluate the dosing requirements, efficacy and safety     of clevidipine for controlled hypotension during spinal surgery in the pediatric population.     As the investigators currently have projects underway which include those patients having     scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing     scoliosis surgery for neuromuscular disease.   "
125293|NCT01645098|"     This is an interventional study on Duchenne muscular dystrophy patients who will be receiving     sedation for a muscle biopsy as part of another study.   "
125294|NCT01645085|"     A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different     Formulations of Fostamatinib.   "
125295|NCT01645072|"     Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic     epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are     difficult to control; sometimes only at the expense of multiple and toxic levels of     antiepileptic medications. The shortcomings of antiepileptic drug therapy and epilepsy     surgery warrants the need for alternative treatments. Ketogenic diet is effective for     refractory epilepsies (33% of patients with refractory epilepsy have more than 50% reduction     in seizures from the baseline and 15-20% become seizure free) and has gained widespread     acceptance. Low glycemic index diet treatment (LGIT) is designed as a variant of ketogenic     diet. There are retrospective studies on LGIT in childhood refractory epilepsy reporting     seizure reduction comparable to that of patients on ketogenic diet. There have been no     randomized controlled trials assessing the efficacy of the low glycemic index diet in     refractory epilepsy. In this study we plan to assess the efficacy of LGIT among children with     drug refractory epilepsy.   "
125296|NCT01645059|"     This is an observational, cross-sectional study that the main objective is to describe the     patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a     metastasis after or during the adjuvant treatment.   "
125297|NCT01645046|"     The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a     natural hypolipidemic compound, coenzyme A （CoA） capsule in Chinese patients with moderate     dyslipidemia.   "
125298|NCT01645033|"     The purpose of this study is to determine if a computerized version of Cognitive Behavioral     Therapy (CBT) can improve high-risk sexual behaviors in patients attending an outpatient     methadone treatment clinic. This population is at high risk for contracting and spreading     hepatitis and HIV. When added to their treatment as usual (TAU), the CBT session will     increase the total exposure of clients to education about how to reduce risky sexual and     needle use behaviors and provides real world examples. This study seeks to determine if the     use of this CBT program is easily added into the clinical program and if patients are     satisfied with its use.      The main hypothesis is that the use of computerized CBT in addition to treatment as usual     will improve knowledge and reduce occurrences of unprotected sexual activity. The study will     also look at patient and clinic costs related to the CBT intervention, drug use and     retention/adherence.   "
125299|NCT01645020|"     Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer     postoperative complications especially less pain caused by the mesh mass.   "
125314|NCT01644825|"     The purpose of this study is to evaluate the safety and activity of adding pazopanib to     weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or     refractory to treatment with platinum based therapy.   "
125315|NCT01644812|"     This two-site (Southern Methodist University (SMU) and Boston University (BU)) study aims to     examine the effectiveness of exercise interventions for the treatment of generalized anxiety     disorder (GAD). If effective, the use of exercise as a component of treatment for GAD would     have a significant public health impact. In addition to improving GAD treatment outcome,     exercise is expected to offer health benefits and promote further lifestyle changes.      The present study involves the randomization of 52 adults with GAD to either a 12-week     combined supervised- home-based moderate-intensity aerobic exercise protocol (EX) or a     12-week combined supervised- home-based stretching protocol (CTRL). The investigators     hypothesize that participants in the EX intervention will evidence greater improvements in     anxiety symptoms and quality of life relative to individuals receiving the control     intervention.   "
125300|NCT01645007|"     Primary Aims:        1. Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee.        2. Educate the population in order to reduce transmission        3. Increase awareness among primary care providers      Secondary Aims:        1. Identify chronic HBV infected patients who need to be followed and treated,        2. Identify HBV infected women in a childbearing age        3. Identify non immunized individuals and recommend vaccination        4. Identify previously vaccinated individuals who are not immunized        5. Identify previously vaccinated individuals who became infected      Study Design:      Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000     people from Druze communities in the Galilee area      This work will be divided into three sections:        1. Increasing awareness: lectures and local events will be taken place in the communities.          Written information will be given and primary care-providers mainly family doctors,          nurses and obstetric surgeons will be involved.        2. All participants, upon signing a consent will:             -  Fill up a questioner             -  Checked for weight, height and waist circumflex             -  Have a blood sample taken        3. Results and recommendations will be forwarded to all participants   "
125301|NCT01644994|"     The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin)     combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural     pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by     evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and     efficacy in phase II with the maximum tolerated dose in phase I.   "
125302|NCT01644981|"     Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm     infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary     dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is     directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker     of BPD.   "
125303|NCT01644968|"     This study is designed to determine the safety and highest tolerated dose of anti-OX40 in     patients with advanced cancer.   "
125306|NCT01644929|"     Rehabilitation after stroke improves motor functions by promoting plastic changes however,     after completing standard rehabilitation, 50-60% of patients still exhibit some degree of     motor impairment and require at least partial assistance in activities of day living.     Therefore, the exploration of other approaches to promote recovery is compulsory. Non     invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms     in inducing neuroplastic changes in the human cortex and an emerging field of research is     focusing on the possibility of coupling both therapies in order to achieve an additive effect     and improve outcome.      We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS)     with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke     patients may improve upper limb motor recovery in humans.      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.     Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers     of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer     Assessment Upper Extremity according to the severity of the deficit, the patient will be     randomized to receive besides standardized physical/occupational treatment according to the     Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12     patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of     treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3     (12 patients) will receive routine physical/occupational treatment and sham tDCS for six     weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months.     Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index,     the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip     strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at     month 6 depression will be assessed by the Hamilton depression Rating Scale.   "
125307|NCT01644916|"     Chronic obstructive pulmonary disease (COPD) stands out among chronic diseases with its high     and rising prevalence and mortality, poor quality of life, high re-hospitalization rates and     societal burden of care. Current therapeutic and management practices are generally met with     limited success. Research in recent years have highlighted the high level of psychiatric     co-morbidity in COPD patients, and the major prognostic significance of anxiety/depression in     COPD outcomes such as re-hospitalization, smoking cessation, quality of life, and survival.     This suggests that addressing psychiatric and psycho-social aspects of care prominent in COPD     patients may have strongly positive impact on outcomes, but the available evidence of     effectiveness is limited.      The primary aim of the proposed research is to evaluate the effectiveness of a holistic     disease management paradigm of psychiatric liaison consultation (CL) that integrates     psychiatric and respiratory care to improve outcomes for COPD patients. This integrated     psychiatric consultation liaison (IPCL) management paradigm includes the routine screening     and structured collaborative care of anxiety and major depressive symptoms and     depressive/anxiety disorder in COPD patients. We postulate that the IPCL care paradigm would     reduce mood symptoms, increase smoking quit rates, reduce symptom burden and functional     disability, and improve quality of life, while reducing rehospitalization, emergency     department (ED) and unscheduled physician visits. A secondary aim is to evaluate its cost     effectiveness by concurrently collecting resource utilization data.   "
125308|NCT01644903|"     This study is being done to test blood, urine and tissue samples to see if this can help     decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can     be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the body's     ability to function properly. Early detection of these conditions could assist with     successful treatment and possibly lead to less repeat organ transplants.   "
125309|NCT01644890|"     To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to     paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent     breast cancer.   "
125310|NCT01644877|"     This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen     and diagnosed with a parainfluenza infection.   "
125311|NCT01644864|"     This is a prospective randomized double-blind placebo controlled study (0.375% Ropivacaine     vs. 0.9% saline) designed to evaluate the effectiveness of transverse abdominis plane (TAP)     block in the first 48 hours after c-section in patients receiving methadone therapy. The TAP     block will be performed by a regional anesthesiologist in the operating room after delivery     of the baby.   "
125312|NCT01644851|"     The purpose of this pilot study is to determine the effects of computer-based training in     executive functioning compared to word games on cognitive and emotional aspects of     combat-related PTSD.   "
125351|NCT01644409|"     Long term open label study on safety and durability of the Urgent-SQ tibial implant device     for refractory overactive bladder syndrome (OAB).   "
125352|NCT01644396|"     This is an open-label study designed to establish the safety and effectiveness of adalimumab     in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.   "
125316|NCT01644799|"     Biologic therapies, such as lenalidomide, may stimulate the immune system in different ways     and stop cancer cells from growing. Idelalisib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. This phase I trial studies the side     effects and the best dose of lenalidomide when giving together with idelalisib in treating     patients with recurrent follicular lymphoma.   "
125317|NCT01644786|"     The purpose of the biobank is to enable future genomic based research on this Head and Neck     Cancer patient population. The investigators will try to identify tumor factors that will     predict cancer-related outcome in order to improve the outcome prediction after treatment in     a patient-individualized manner.   "
125766|NCT01638871|"     The purpose of this study is to translate a proven pain coping skills intervention for     osteoarthritis (OA) patients into an engaging and easy-to-use Internet-based intervention     that uses innovative technologies to mimic traditional, in-person training sessions.   "
125318|NCT01644773|"     This is a phase I study to find the highest tolerable dose of crizotinib and dasatinib given     in combination to patients with diffuse intrinsic pontine glioma (DIPG) and other types of     high grade gliomas (HGG). Participants will receive escalating doses until the highest dose     is determined. Participants will be enrolled in two strata: stratum A for recurrent/     progressive tumors and stratum B for recently diagnosed patients who have completed standard     radiation therapy without progressive disease. Up to 7 dosage levels will be tested. Both     drugs are taken orally daily, once per day. Correlative pharmacokinetic and biology studies     are planned, as well as advanced methods of magnetic resonance imaging (MRI).   "
125319|NCT01644760|"     The main objective of this study is to determine a threshold value of diaphragmatic excursion     (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility     of the inferior vena cava.   "
125320|NCT01644747|"     The aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS)     applied at the anodal left CDLPF of patients with resistant depression compared to patients     treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant     depression stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake     Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients     and lithium for bipolar patients). The delay of 4 weeks is a minimum to observe a     non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8 weeks     to observe the non-response to treatment.      This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients (48     unipolar plus 12 bipolar patients per group. Patients will be selected in the psychiatric     department of the University Hospital of different centers and the two groups are matched for     age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).      After giving informed consent, patients will be evaluated by a psychiatrist using the     Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS),     the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young Mania     Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist assessment     will be also realized during 20 minutes using the Crossing of Test (COT), the Trail Making     Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.      After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will     be directed by 30-minute session. A psychometric assessment will be conducted again at the     end of treatment week and 4, 12 and finally 24 weeks after stopping treatment. The     neuropsychologist assessment will be conducted again 4 weeks after the end of treatment.     Scales of comfort and acceptability will also be proposed to the patient to determine whether     any gene is caused by this treatment.      These people will be recruited on a voluntary basis, after notification and consent in the 6     research centers. This study was conducted over a period of 36 months.      This study was supporting by a grant from the French Hospital Program of Clinical Reseach     (PHRC N/2011-60-2011-A01074-37)   "
125321|NCT01644734|"     To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH     maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the     real life setting of COPD patients, previously treated with short-acting bronchodilator on     regular or as-needed basis.   "
125322|NCT01644721|"     Background: All observational studies and a few randomised controlled trials (RCT) suggest     that early measles vaccine (MV), in particular an early two-dose strategy, has a much better     effect on overall mortality than later MV. These results suggest that MV has a non-measles     related beneficial effect on child survival.      Objective: To evaluate in a two-site RCT the effect on child survival and other health     indicators of a two-dose measles vaccination schedule by providing an additional dose of     Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard     measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso.     The investigators will test a 40-43% reduction of mortality at each site separately and a 32%     reduction overall. Based on the results from the RCT, the investigators will assess the     cost-effectiveness of the intervention.      Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance     System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations     will be collected regularly through home visits and health centre registers. Four weeks after     having received the third dose of pentavalent vaccine (Penta3), the children will be eligible     for enrollment in the trial if they are not severely ill. Eligible children will be invited     to take part in the trial. Provided parental informed consent is given, the children will be     randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based     on consumption of services and average cost per unit. The incremental cost effectiveness     ratio will be calculated.      Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each     site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The     children will be followed for survival and hospitalisations to 3 years of age or to the end     of the study after three years. The investigators will analyse the effects by site and     combined; by sex and season; possible interactions with other interventions like campaigns     with drugs, vaccines or micronutrients will be explored.      Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of     maternal antibody levels on subsequent antibody responses to MV. The children will be     followed to 24 months of age and samples collected at 4, 9 and 24 months of age.   "
125323|NCT01644708|"     Overweight and obesity put an heavy burden over people's health. Many methods are reported in     medical literature but none of them proved to be effective in maintaining the results     achieved over time. Motivational change remains a fundamental step towards the maintenance of     a new lifestyle. Strengthening personal capabilities and self-esteem seem to be key     strategies in motivating persons for change and facilitating a capacity of coping.      The aim of this study is to observe the effects of an individual empowerment program on the     health of a group of overweight/obese persons.   "
125324|NCT01644695|"     Abdominal wall incisional hernia is a common finding in patients who have undergone previous     intra-abdominal surgeries. Common methods of abdominal fascial closure include primary     closure, mesh inlay versus onlay, with or without component separation. All these methods     have been shown to have recurrence rates for hernia between 3%-60% in the literature. The     study describes the investigators innovative and preferred method for reconstruction of the     abdominal wall as BARS (bony anchoring reinforcement system). This method manages the     abdominal fascial integrity to reduce the recurrence of incisional hernia while providing an     aesthetically superior abdominal wall contour.   "
125353|NCT01644383|"     Logotherapy has never been evaluated in HIV-infected teenagers. In this study, we will     evaluate the meaning of life by using The Purpose in Life Test and the affect of logotherapy     in HIV infected youth at HIV-NAT, Thai Red Cross AIDS Research Centre and King Chulalongkorn     Memorial Hospital.   "
125354|NCT01644370|"     To explore allergen-specific effector and regulatory T cell response in HIV-infected children     before and after HAART initiation   "
125325|NCT01644682|"     Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To     control the disease in these three countries a National kala-azar elimination program is     ongoing. One of the major pillars of the elimination program is VL vector control. Currently     there is a no public VL vector control program in Bangladesh. In India the program is     depending on Indoor Residual Spraying with insecticides. IRS with DDT and in Nepal on     Alpha-cypermethrin. The sand fly, vector of VL is already resistant to DDT and hurdles     related with IRS i.e. funds, logistics and human resources make IRS unsustainable VL vector     control method in Nepal. Thus alternative to IRS for VL vector control is highly desirable     for the success of national kala-azar elimination program in these three countries.      Through current research activities we will compare the effectiveness of three effective VL     vector control methods. They are 1) Plastering of household walls with lime (a traditional     method known in the study areas),treatment of possible sand-fly breeding places with lime and     bleaching powder; 2) Installing durable wall lining containing deltamethrin in the main     living room(s) of households; 3) Impregnation of existing bed-nets with slow release     insecticide tablet containing deltamethrin.      The study finding will be important for the national elimination program of the three     countries through discovering the most effective VL vector control method.   "
125326|NCT01644669|"     The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System     when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the     Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when     used as stand-alone radiation treatment in breast conserving therapy in women with early     stage breast cancer.   "
125327|NCT01644656|"     The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type     of ultrasound) in assessing the pressure of the portal vein (the major vein passing through     the liver) and the amount of liver fibrosis in patients with chronic liver disease.   "
125328|NCT01644643|"     To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with     complicated urinary tract infections and complicated intra-abdominal infections.   "
125329|NCT01644630|"     The aim of this study is to test whether or not the use of screw-retained implant crowns on     customized zirconia abutments results in biological, technical and esthetic outcomes similar     to those obtained with cemented all-ceramic crowns on customized zirconia abutments, both     made with a computer-aided design and manufacturing procedure (CAD/CAM).      The null-hypotheses is that marginal bone level change is equal at screw-retained and     cemented crowns   "
125330|NCT01644617|"     The purpose of this study is to evaluate the dose-related effectiveness, the safety and the     tolerability of MK-8237, compared to placebo, in the treatment of house dust mite     (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that     administration of MK-8237, compared to placebo, results in dose-related improvement in the     average total nasal symptom score (TNSS) determined during environmental exposure chamber     (EEC) challenge.   "
125331|NCT01644604|"     The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a     safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3     or more anti-hypertensive medications of different classes, of which one must be a diuretic,     as best available antihypertensive therapy   "
125332|NCT01644591|"     The goal of this clinical research study is to find out if stereotactic radiosurgery (SRS)     can control the disease in patients with more than 3 melanoma brain tumors.      SRS is the delivery of focused, high-dose radiation given in a single session to the tumors     with a minimal dose given to uninvolved areas of the brain.   "
125333|NCT01644578|"     This research study is being done to look at a new MRI imaging software, Siemens     Interventional Software, to see if we can improve our ability to see and treat cancerous     tumors.   "
125334|NCT01644565|"     The purpose of the study is to determine if immunization with a chimeric E. coli protein,     dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.   "
125335|NCT01643564|"     Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft     dysfunction.   "
125336|NCT01643551|"     An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD     recipients before and following VAD implantation.   "
125337|NCT01643538|"     The goal of this randomized and controlled trial is to test whether a financial incentive of     a donation to achieve a social goal is more effective to motivate and sustain a daily walking     habit than the same dollar value given to an older adult. The investigators will achieve this     using a novel computer platform utilizing a digital pedometer-internet interface.   "
125338|NCT01643525|"     That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to     hyper acute ischemic stroke than does CT.   "
125339|NCT01643512|"     Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the United     States. The cause of NAFLD is poorly defined but is thought to involve complex interactions     of genetic and environmental factors. NAFLD is often associated with the traits of the     metabolic syndrome including diabetes, high cholesterol or elevated blood pressure.     Currently, there are no accurate noninvasive means of evaluating NAFLD and its more serious     form which includes inflammation that may lead to severe scarring in the liver. The goal of     this study is to evaluate shared genetic factors that underlie NAFLD and features of the     metabolic syndrome as determined by blood work and radiographic studies in a cohort of twins     and first degree relatives.   "
125340|NCT01644552|"     Patients with aniridia have positive angle kappas.   "
125355|NCT01644357|"     Only a few well-designed studies have investigated the effect of pharmaceutical care on     asthma patients and to date there are no published studies investigating this effect     specifically on severe and refractory asthma.      The objective of this study is evaluate the effect of pharmaceutical care on asthma control     and quality of life (QoL) of patients with severe or refractory asthma compared with     pharmacist dispensation only.   "
125397|NCT01643798|"     Studies have shown that transcranial magnetic stimulation (TMS), a non-invasive form of brain     stimulation, can reduce pain in the laboratory and in the clinic. The purpose of this study     is to investigate how TMS relieves pain and affects pain circuitry in the brain. One of the     primary study hypotheses is that opioid blockade will significantly reduce the pain relief     produced by left prefrontal cortex TMS.   "
125341|NCT01644539|"     The amount and kind of food which is ingested influences the regulation of meal size. Neural     signals from the gastrointestinal tract travel via the vagus nerve to the brainstem and     thalamus, which projects to the rest of the brain, in particular the hypothalamus, amygdala     and primary sensory cortices. In neuroimaging studies in which the stomach was distended with     a gastric balloon activation was observed in the right insula, left posterior amygdala, left     posterior insula, left inferior frontal gyrus and anterior cingulate cortex. So far, no study     has examined the effects of the ingestion or infusion of a food on the brain. In addition to     neural signals, hormonal signals are important for meal termination. Hormones like insulin,     ghrelin and cholecystokinin interact with gastric as well as sensory signals in the process     of satiation, which ultimately leads to meal termination. The aim of this study is to     investigate the interaction between food administration, hormone responses and brain     responses. To this end an oral or intra-gastric load will be administered while measuring     brain activity (functional magnetic resonance imaging) and hormone concentrations. Subjects     will participate in one trainings session and in three functional magnetic resonance imaging     (fMRI) sessions (35-min fMRI scan). A training session will take 40-minutes and consists of     placing a naso-gastric tube and ingesting 500 ml of chocolate milk orally. The fMRI sessions     will consist of three conditions: in condition one (A) 500ml of chocolate milk will be     administrated orally. In condition two (B) and three (C) an intra-gastric load of 500 ml is     administrated.   "
125357|NCT01644331|"     The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo     as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute     decompensated heart failure      The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will     be more effective at relieving dyspnea than fixed dose furosemide alone   "
125358|NCT01644318|"     The purpose of this study is to measure serum CXCL9 and CXCL11 levels in patients with     autoimmune thyroiditis and habitual abortions   "
125342|NCT01644526|"     The ability to selectively control blood flow through an arteriovenous (AV) graft only when     it is needed for dialysis may reduce the current repetitive complications such as thrombosis,     venous hypertension and blood steal from the extremities. The Hemoaccess Valve System (HVS)     allows an AV graft to be turned on to blood flow when it is needed for dialysis then when     dialysis is concluded, the device's valves are activated, shutting off the flow of blood     through the graft. The graft is then flushed with sterile saline using the dialysis blood     lines. By having only saline in the graft and restoring normal blood flow to the artery and     vein, it is believed that this will dramatically reduce the current complications with having     blood diverted through the graft 24/7.   "
125343|NCT01644513|"     Patients with AMD who are being or have been treated with eye injections of drugs known as     anti-VEGF agents with either good or poor response will have DNA collected with check swabs     for analysis.   "
125344|NCT01644500|"     The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe     compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate     glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.   "
125345|NCT01644487|"     The objectives of this study are to compare directly conventional balloon angioplasty alone     versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty     with self-expanding stent is superior to conventional balloon angioplasty - in the     infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting     and analyzing the cases of each patient group in a prospective multicenter randomized     clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of     angioplasty with self-expanding stent in the infrapopliteal arteries.      Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in     critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to     conventional PTA in the aspect of vascular restenosis rate.   "
125346|NCT01644474|"     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9     (proprotein convertase subtilisin/kexin type 9).      Primary Objective of the study:      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in     comparison with ezetimibe after 24 weeks of treatment in participants with     hypercholesterolemia.      Secondary Objectives:        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time          points        -  To evaluate the effect of alirocumab on other lipid parameters        -  To evaluate the safety and tolerability of alirocumab   "
125347|NCT01644461|"     This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous     Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is     being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle     Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile     and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in     photographic assessment, Physician's assessment scores, Patient's assessment scores form     enrollment to end of study.   "
125348|NCT01644448|"     This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of     Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is     being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self     assessment score. The secondary endpoints are improvement in photographic assessment form     randomization to end of study.   "
125349|NCT01644435|"     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of     Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2     centers in India. The primary endpoint is change in the Global Acne scarring classification     scores from screening to end of the study. The secondary endpoints are Photographic     Assessment, Physicians assessment score and Patients self assessment score.   "
125350|NCT01644422|"     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of     Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair     transplantation. The study is being conducted at 2 centers in India. The primary endpoints     are Increase in Hair Follicle viability after transplant, Improvement in Caliber & Density of     hair and Improvement in Photographic assessment from randomization to end of study. The     secondary endpoints are Physicians and Patients self assessment score.   "
125356|NCT01644344|"     The standard post-operative radiographic protocol for the monitoring of fractures at HSC     includes post-operative in hospital radiographs as well as radiographs at the two week follow     up appointment. This is in addition to good quality intra-operative radiographs. With current     operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal     fixation. In fact, patients are often allowed to take weight through the fractured limb     immediately post-operatively. In these cases, redundant post-operative radiographs likely     represent an avoidable cost to the system financially, and an avoidable cost to the patient     in additional time spent in hospital and unnecessary radiation exposure.   "
125359|NCT01644305|"     The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their     association with bone and cardiovascular parameters in patients with Polycystic Ovary     Syndrome.   "
125361|NCT01644279|"     The age-related loss of muscle mass and strength, also termed sarcopenia, is a commonly     recognized consequence of aging and has been associated with frailty, functional loss,     hospitalization, and increased mortality among older people. Sarcopenia and its consequences     have a considerable economic impact, since it has been estimated that the healthcare cost     attributable to sarcopenia in the US in 2000 was $ 18.5 billions. Preclinical animal models     strongly suggest that apoptosis, a programmed cell death, might play a prominent role in the     age-related muscle wasting. In specific aim one, the investigators will assess the extent of     muscle apoptosis in muscle biopsies obtained from the vastus lateralis muscle of young     control subjects (ages 20-35) and high-performance and low-performance older subjects (age     range 70-99 years). In specific aim 2, the investigators will investigate the role of Poly     (ADP-ribose) polymerase 1 (PARP-1) and apoptosis-inducing factor (AIF) in the induction of     skeletal muscle apoptosis. In specific aim 3, the investigators propose to investigate the     contribution of the muscle energy deficit, due to the age-related mitochondrial dysfunction,     in the development of muscle wasting. Finally, in specific aim 4, the investigators propose     to reassess after four years physical performance, muscle mass and the extent of muscle     apoptosis, in the high-performing participants, in order to correlate eventual decline in     physical function, muscle mass and functional status, with changes in muscle apoptosis and in     biochemical parameters in this very old population. Physical performance will be established     according to the summary performance score obtained in the Short Form Physical Performance     Battery (SPPB). In addition to the SPPB the investigators will also employ hand grip strength     and knee extensor strength tests and the investigators will quantify muscle contractile area     using 3D magnetic resonance imaging. Disability will be assessed using a self-report     questionnaire. These studies will enhance our understanding of the biology and     pathophysiology underlying the geriatric syndrome of sarcopenia and provide significant and     novel insights that will enable us to identify new potential targets for interventions aimed     at preventing and treating sarcopenia and functional impairment in older adults.   "
125362|NCT01644253|"     The purpose of this study is to evaluate the safety and efficacy of TRU-016 when when     administered in combination with rituximab or obinutuzumab, in combination with idelalisib     and rituximab, or in combination with ibrutinib in patients with chronic lymphocytic leukemia     (CLL).   "
125363|NCT01644240|"     This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the     safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy     adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy     elderly subject population is included to evaluate the safety, tolerability, and PK of     TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for     all cohorts will be conducted within 21 days before the first dose.   "
125364|NCT01644227|"     Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip     arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.      Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk     but increase the incidence of postoperative infection.   "
125365|NCT01644214|"     Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are     commonly used in conservative treatment. Despite their prevalence, there is no literature to     guide the management of pessaries. Our objective is to determine whether patients managed     with a pessary for POP are more satisfied with follow-up at 3 or 6 month intervals and if     there is any difference in complications rates between the two groups.      Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in     the group randomized to 6 month follow-up intervals and that there will be no difference in     complication rates between the two follow-up groups.      Method: The investigators will conduct a prospective randomized control trial comparing     patient satisfaction and complication rates between patients with pessaries randomized to     either 3 or 6 month follow-up intervals over 1 year.   "
125366|NCT01644201|"     One out of two adults in Canada is currently overweight and therefore at increased risk for a     number of medical conditions including diabetes, high blood pressure, heart attacks and     stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre,     suggesting that fibre intake could play an important role in prevention and progression of     obesity and diabetes and other conditions. Several studies have suggested that fibre has a     positive effect on blood sugar and may help lower body weight.      The purpose of this study is to help better understand the effect of adding fibre     supplementation to a low calorie diet on blood sugar control and weight loss. The     investigators hypothesize that blood sugar control will improve in participants in the fibre     supplementation group.      Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months),     between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can     participate in this study.   "
125367|NCT01644188|"     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9     (proprotein convertase subtilisin/kexin type 9).      Primary Objective of the study:      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as     add-on therapy to stable maximally tolerated daily statin therapy in comparison with     ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high     cardiovascular (CV) risk.      Secondary Objectives:        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time          points        -  To evaluate the effect of alirocumab on other lipid parameters        -  To evaluate the safety and tolerability of alirocumab   "
125368|NCT01644175|"     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein     convertase subtilisin/kexin type 9 (PCSK9).      Primary Objective of the study:        -  To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by          alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or          without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of          treatment in high cardiovascular (CV) risk participants with hypercholesterolemia      Secondary Objectives:        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time          points        -  To evaluate the effect of alirocumab on other lipid parameters        -  To evaluate the safety and tolerability of alirocumab   "
125369|NCT01644162|"     The aim of this study is to determine whether respiratory disease exacerbations (a sudden     worsening of symptoms) can be predicted by variables that are monitored by non-invasive     ventilators (small machines that assist breathing) in patients requiring long term home     ventilation.      The investigators hypothesise that acute exacerbations of patients with respiratory disease     and ventilatory failure will be predicted by changes in the respiratory variables monitored     and stored by ventilators during chronic home ventilator use.   "
125370|NCT01644149|"     The primary objective of this study was to evaluate if administration of a seasonal flu     vaccine using a jet injector device is comparable to traditional needle and syringe delivery     for eliciting an immune response. A secondary objective was to compare the safety of the two     delivery methods.   "
125371|NCT01644136|"     This study is being performed to investigate if the application of Arista absorbable hemostat     (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are     collections of lymphatic fluid which can occur after a lymph node dissection for cancer.     These fluid collections can become symptomatic in some patients. Arista would be applied to     one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the     number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after     surgery   "
125372|NCT01644123|"     Spasticity is a condition that results from damage to the central nervous system and causes     painful muscle contractures that drastically affect level of independence, activities of     daily living, and quality of life. Although there are well-known and accepted treatments for     spasticity, spasticity is often left undertreated; the specific reasons for this observation     are unknown. Because there is no blood test or scan that indicates the presence of     spasticity, diagnosis is based entirely on physician impression. Therefore, the investigators     hypothesize that one reason that spasticity is undertreated is due to the lack of a     standardized diagnostic procedure. This study attempts to test the reliability of a     diagnostic flowchart that seeks to increase the accuracy of physician diagnosis of     spasticity.   "
125373|NCT01644110|"     The proposed study is an open-label, single-arm, Phase-Ib/II trial to assess the efficacy of     oral drug combination ruxolitinib and pomalidomide in primary and secondary MF patients.   "
125374|NCT01644097|"     This randomized phase II clinical trial studies probiotic supplementation in preventing     treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may     help prevent diarrhea caused by treatment with chemotherapy.   "
125375|NCT01644084|"     It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary bypass     (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin decreases     coagulopathy, platelet aggregation, immune responses. However the use of albumin is limited,     because it is expensive and can rarely cause infection.      Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently     developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA et     al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced     impairment in fibrin formation and clot strength in thromboelastometry tracings.      Coagulopathy is directly related to bleeding and massive postoperative bleeding increases the     risk of reoperation. Therefore it is important to avoid administration of fluids that can     inhibit homeostasis after CPB.      The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of     priming solution on coagulation compared to 5% HA.   "
125376|NCT01644071|"     Aggressive behavior (AB) is a major burden to society with severe socio-economic     consequences. Genetic studies suggest a high heritability of AB; in particular, the low     expressing allele of the MAOA gene (MAOA-L) has been associated with increased AB. Recent     neural aggression models have suggested a dysfunctional emotion regulation circuit including     amygdala, orbitofrontal, and anterior cingulate cortex. Dysregulated serotonergic (5-HT)     projections from the anterior cingulate cortex to the amygdala have been suggested to promote     aggressive behavior. This finding is well in line with the observation that the MAOA-L allele     leads to a reduced expression of monoamine oxidase A and thus to an overflow of 5-HT in     serotonergic cortico-amygdalar projections. However, due to methodological and ethical     constraints, the neural substrates of AB are difficult to assess. A possible solution is the     use of virtual violence which permits AB against virtual characters without direct     consequences for any real person and can be easily applied in functional imaging experiments.     There is evidence that virtual and real aggression share common neural substrates. AB in     violent video games inhibits rostral anterior cingulate cortex (ACC) and amygdala in line     with the suggested neurophysiological circuits underlying real-life AB.   "
125377|NCT01644058|"     Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular     overdenture assisted by 2 immediately loaded unsplinted implants.   "
125378|NCT01644045|"     The aim of the study is to investigate the quality of prehospital emergency care in acute     respiratory emergencies, when paramedics are supported telemedically by an EMS physician.   "
125379|NCT01644032|"     The aim of the study is to evaluate the safety and efficacy of telemedically supported and     delegated pain therapy in the Emergency Medical Service (EMS).   "
125380|NCT01644019|"     The aim of the study is to investigate the quality of prehospital emergency care in acute     stroke, when paramedics are supported telemedically by an EMS physician.   "
125381|NCT01644006|"     The aim of the study is to investigate the quality of prehospital emergency care in acute     coronary syndromes, when paramedics are supported telemedically by an EMS physician.   "
125393|NCT01643850|"     This study, designed as a proof of concept study of MCS110 in pigmented villonodular     synovitis, will assess the clinical response to MCS110 treatment in Pigmented Villonodular     Synovitis (PVNS) and Giant cell tumor of the tendon sheath (GCTTS) patients after multiple     intravenous doses of MCS110 using magnetic resonance imaging to assess tumor volume, and to     evaluate pharmacokinetics/pharmacodynamics, safety and tolerability in this population.   "
125394|NCT01643837|"     There are many current medical treatments for mastalgia, but few have been proven effective.     Our objective is to evaluate the effectiveness of osteopathic manipulative treatment as     compared to a light touch protocol and standard management in the treatment of women with     cyclical and non-cyclical mastalgia. We will compare duration of the pain, severity of the     pain and the effect of the pain on quality of life.   "
125382|NCT01643993|"     Techniques to improve pregnancy and delivery rates in IVF cycles have focused not only on the     embryos transferred, but also the conditions in the uterus at the time of transfer and     implantation. Prior studies have shown that embryos secrete human chorionic gonadotropin     (hCG) prior to implantation. However, in IVF cycles, the embryos have limited time to secrete     hCG before implantation must occur because embryos are placed into the uterus rather than     traveling there from the fallopian tubes. Recent studies have shown that the introduction of     hCG into the uterus prior to embryo transfer may make the uterus more receptive to     implantation. These studies involved day 3 embryos and the investigators are seeking to     evaluate the potential benefits of hCG on implantation rates of blastocysts (day 5 or day 6     embryos).      The purpose of this study is to determine whether infusion of human chorionic gonadotropin     (hCG) into the uterus immediately prior to embryo transfer results in increased implantation     rates.      The entire IVF cycle, fresh or frozen, will be conducted per routine. All laboratory culture     conditions will be per routine. In fresh and frozen IVF cycles, an embryo transfer will be     performed per routine.      At the time of embryo transfer, participants will be randomly assigned to either the control     group or the hCG group. Patients in the hCG group will have a mock embryo transfer with 20µL     of transfer media including 500IU of hCG. Patients in the control group will have a mock     embryo transfer with 20µL of transfer media.      All post-transfer care and pregnancy monitoring will be identical and per routine protocol.   "
126628|NCT01627613|"     The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid     clearance in ALI (acute lung injury) patients with the purpose to assess the treatment     associated changes of extravascular lung water (EVLW) within 7 days of treatment.   "
125383|NCT01643980|"     The preterm birth is considered as a main problem in the modern obstetrics, being the     responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the     significant medical advances, the rate of prematurity has not declined over the past 40 years     and even continues to rise in the developed countries. In order to decrease the prematurity     is necessary that two premises: to identify the pregnant women at risk of preterm birth, and     dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm     delivery. The investigators propose a clinical trial with the objective to identify effective     strategies to reduce the premature birth (34 weeks and earlier) rate in the population of     pregnant women at risk for premature birth, which will be identified by ultrasound during the     second trimester of their pregnancy.      The investigators intend to compare two accepted strategies: administration of progesterone     (vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy to     apply, and they present very few maternal-fetal secondary effects.   "
125384|NCT01643967|"     This is a open, phase III, multicenter, prospective, comparative, controlled, randomized     clinical trial to evaluate the efficacy and safety of the use of ozone released by Philozon     Medplus device versus conventional therapy in treating patients with diabetic foot.   "
125385|NCT01643954|"     This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.   "
125386|NCT01643941|"     This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of     a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose     level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). The main goal of the study is to     determine how safe and well tolerated the vaccine is as well as to describe the immune     response elicited by the vaccine in healthy adults aged 65 to <86 years. In addition, the     study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the     Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to     <86 years.   "
125387|NCT01643928|"     This extension study will evaluate the safety (including immunogenicity) of treatment with     rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from     rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment     access to subjects with active rheumatoid arthritis who have participated for at least 16     weeks in other studies in the rituximab Pfizer program.   "
125388|NCT01643915|"     The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric     patients during dental treatment improves when a cartoon film is viewed or a videogame is     played as methods of distraction.   "
125389|NCT01643902|"     The primary objective of this study is to evaluate the safety of intravenous tissue     plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and     presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting     standard criteria for treatment with IV tPA for acute stroke.      The hypothesis is that patients that wake up with stroke symptoms may have developed the     stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the     ED within that time, therefore IV tPA should be safe and effective in this population.   "
125390|NCT01643889|"     The purpose of this study is to assess the effects of single and multiple doses of     domperidone on the QTc interval duration in healthy adult volunteers at domperidone doses of     10 mg four times a day (q.i.d.) and 20 mg q.i.d.   "
125391|NCT01643876|"     Palatal brushing has several advantages including removal of debris and stimulation of blood     flow and saliva, which may help to prevent or treat oral diseases, such as denture-related     stomatitis in complete denture wearers.      However, there is no previous clinical trial testing this effect. Therefore, the     investigators goal is to evaluate whether palatal brushing may change the severity of denture     stomatitis and counts of microbes on denture and palatal mucosa.      After an initial exam and data collection, participants will receive instructions about     palatal brushing and they will be assessed after 1 and 3 months. Collection of data will     include patient-reported information, intraoral photographs and swabbing (for counting     microbes).      Tested Hypotheses:        -  There is no difference in the extent of palatal inflammation in edentulous patients with          denture stomatitis before and after 3 months of palatal brushing.        -  There is no difference in the number of colony forming unit (CFU) of Candida isolated          from palate and denture of patients affected by denture stomatitis before and after 3          months of palatal brushing.   "
125392|NCT01643863|"     This multi-center observational study will evaluate the use of RoActemra/Actemra     (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients     initiated on RoActemra/Actemra treatment according to the licensed label will be followed for     6 months.   "
125398|NCT01643785|"     Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a     reduction in mucus viscosity. As part of the search for more effective forms of therapy     against H. pylori when it colonizes not only the surface of the surface mucosal cells but     also the surface mucous gel layer covering the mucosal surface of the stomach. The     investigators decided to investigate whether or not endonase might have additive effect of     pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.   "
125399|NCT01643772|"     A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a     multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with     pain.It will be a single center, open label, randomized, oral administration study.   "
125400|NCT01643759|"     This is a single center, open label, randomized, parallel group single dose pharmacokinetic     (PK) study.   "
125401|NCT01643746|"     The primary goal of this trial is to compare prospectively stent opening of Supera (IDEV     Technologies) versus a reference stent (LifeStent, Bard Medical) using C-arm CT. A secondary     goal is to correlate stent opening with stent patency as documented by Doppler ultrasound at     one year post implantation.   "
125402|NCT01643733|"     Hypothesis: The primary objective of this study is to assess whether using a flow measurement     device, in this case the Transonics flow device, as an end-point to interventional treatment     of diseased dialysis fistulae can help increase immediate treatment success in terms of     quality of dialysis immediately following the treatment and increasing time to     reintervention.   "
125403|NCT01643720|"     In the proposed study, the investigators would like to investigate the emotion regulation     (ER) strategies children with Autism Spectrum Disorders (ASD) demonstrate, and the influence     parents have on their children's ER. More specifically, the investigators would like to     examine what are the ER mechanisms that parents use, what mechanisms of self regulation     children with autism internalize, and how parents support and improve the ER capabilities of     their child with ASD. These will be studied in a behavioral level, using micro-analysis of     parent-child interaction, and in a physiological level, using indexes of stress control and     affiliation. In addition, in order for parental ER support to be effective, it is important     to consider more innate neuro-developmental difficulties children with ASD demonstrate that     strongly affect their ability to regulate themselves. These include sensory regulation     difficulties, temperament, attention disorders and poor executive functioning.      Hypotheses:        1. ER strategies used by children with ASD will be more poorly developed and less          effective, compared to those of children in the control groups.        2. Difficult temperament and sensory regulation difficulties will hamper ER in children          with ASD.        3. ER strategies of parents of children with ASD will be more poorly developed and less          effective than those of parents in the control groups.        4. Good parental self-ER and parental attunement to the child will be predictive of          improved ER in children with ASD, and in parent-child synchrony, both in the behavioral          and in the physiological levels.   "
125404|NCT01643707|"     Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)      The study is expected to provide evidence to support claim(s) that:        -  Education and process improvement initiatives can improve the diagnosis of and          appropriate therapy application for sinus node dysfunction (SND)        -  The quality improvement methods studied have general applicability and can be used by          all centers        -  Appropriate treatment minimizes caregiver burden        -  Appropriate treatment improves quality of life (QOL) and functional status compared to          pre-implant   "
125405|NCT01643694|"     To determine if physicians who complete brief tasks intended to promote meaning in work and     job satisfaction, foster teamwork and social support at work, nuture personal relationships     and work-life balance, recognize and build on personal strengths, encourage effective problem     solving, and promote positive emotions have improved resilience, meaning in work, and     engagement at work.   "
125406|NCT01643681|"     The purpose of this study is to investigate the efficacy and safety of autologous     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with     lumbar intervertebral disc degeneration.   "
125407|NCT01643668|"     This research is a phase II clinical trial. Phase II clinical trials test the effectiveness     of an investigational intervention to learn whether it works in treating a specific cancer.     Investigational means that the study intervention is still being studied and that research     doctors are trying to find out more about it. It also means that the FDA has not yet approved     this study intervention for your type of cancer.      All participants on this study are treated in an identical manner. The investigators are     doing this study because there continues to be a significant risk of relapse of disease after     reduced intensity transplantation. In studies which have compared transplants using     high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients     undergoing reduced intensity transplants appear to have higher rates of relapse, but lower     rates of toxicity and complication. This study attempts to utilize clofarabine, a newer     chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor     effects of the conditioning regimen without accumulating unacceptable toxicity.      The reduced intensity allogeneic stem cell transplantation procedure involves giving you     chemotherapy in relatively less intense doses to suppress your immune system. This is     followed by an infusion of healthy blood stem cells from a matched related donor or a matched     unrelated volunteer donor. It is hoped that these donor cells can eventually then attack any     cancer cells which remain.      In this research study, the investigators are looking to see how well this new combination of     busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation. By     works the investigators mean to analyze safety, ability of donor cells to engraft (take     hold), as well as measures of complications including toxicity, infections, graft-vs-host     disease (GVHD), and relapse.   "
125409|NCT01643642|"     This study compares both clinical effectiveness and cost-effectiveness of a brief,     intensified therapy and diagnostic method for patients with mood and/or anxiety disorders     with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the     Netherlands.   "
125410|NCT01643629|"     This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of     Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being     conducted at 2 centers in India. The primary endpoints are Improvement in Caliber & Density     of hair and Improvement in Photographic assessment from randomization to end of study. The     secondary endpoints are Physicians and Patients self assessment score.   "
125411|NCT01643616|"     For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided     distal subepineural block tested the hypothesis, that intraepineural injection of local     anesthetic using nerve stimulation technique is common and associated with high success rate.   "
125511|NCT01642238|"     The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and     bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and     bivalirudin).   "
125412|NCT01643603|"     This study uses a drug called dasatinib to produce an anti-cancer effect called large     granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as     natural killer cells that remove cancer cells. Researchers think that dasatinib may cause     large granular lymphocyte expansion to happen in patients who have received a blood stem cell     transplant (SCT) between 3 to 15 months after the SCT. In this research study, researchers     want to find how well dasatinib can be tolerated, the best dose to take of dasatinib and how     to estimate how often large granular lymphocytic cellular expansion happens at the best dose     of dasatinib.   "
125413|NCT01643590|"     This is a randomized, double-blind, placebo controlled Phase II study is designed to assess     the safety and efficacy of using JVS-100 to treat heart failure.   "
125414|NCT01643577|"     Gastroparesis is a disorder characterized by delayed gastric emptying leading to symptoms of     nausea, vomiting, bloating, and abdominal pain. A common cause is diabetes but even more     often it occurs in otherwise healthy individuals. The symptoms of gastroparesis can     significantly alter a patient's quality of life. Current therapies are limited. In this     study, the investigators seek to determine if twice weekly acupuncture treatments can improve     symptoms of gastroparesis.   "
125415|NCT01643499|"     This study is being done to determine the dose of a chemotherapy drug (irinotecan [irinotecan     hydrochloride]) that can be tolerated as part of a combination of drugs. There is a     combination of chemotherapy drugs often used to treat gastrointestinal cancer, which consists     of 5-FU (fluorouracil), leucovorin (leucovorin calcium), irinotecan and oxaliplatin and is     known as FOLFIRINOX. FOLFIRINOX is a current drug therapy combination (or regimen) used for     people with advanced pancreatic cancer, although this combination is not Food and Drug     Administration (FDA) approved for this indication. FOLFIRINOX was recently shown in a     separate clinical trial to increase survival compared to another commonly used drug in     pancreatic cancer called gemcitabine. FOLFIRINOX is also a reasonable regimen for those with     other advanced cancers of the gastrointestinal tract, including colon cancer, rectal cancer,     esophagus cancer, stomach cancer, gall bladder cancer, bile duct cancer, ampullary cancer,     and cancers with an unknown primary location. The best dose of irinotecan to use in     FOLFIRINOX is not known. This study will analyze one gene (uridine 5'-diphospho [UDP]     glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] gene) of subjects for the presence     of an alteration in that gene, which may affect how the body handles irinotecan. Genes help     determine some of the investigators individual characteristics, such as eye color, height and     skin tone. Genes may also determine why people get certain diseases and how medicines may     affect them. The result of the genetic analysis will divide subjects into one of three     groups: A, B, or C. Group A (approximately 45% of subjects) will receive the standard dose of     irinotecan. Group B (approximately 45% of subjects) will receive a lower dose of irinotecan.     Group C (approximately 10% of subjects) will receive an even lower dose of irinotecan   "
125416|NCT01643486|"     Hypothesis: The use of a program that assists with selection of the appropriate number of     phosphate binders for a meal based on patient specific factors will result in improved serum     phosphate control, a reduction in overall number of phosphate binders used and enhanced     patient satisfaction.      Primary Aim: To determine if teaching patients to use a 'phosphate counting' program     installed on an iTouch that selects the appropriate amount of phosphate binder to be taken     with each meal is associated with better phosphate control than usual care.      Research Plan: There will be 3 phases to the study. Phase 1: Recruitment of 60 peritoneal     dialysis (PD) patients. The information generated from this phase will be used to develop the     iTouch program for phosphate counting and matching binder number. Phase 2: iTouch program     once developed will be pilot tested on a convenience sample of 10 PD patients and modified if     required. Phase 3: Randomized controlled trial of 92 PD patients to determine if using the     iTouch phosphate counting program reduces serum phosphate compared to controls. Success would     be based on seeing a statistically significant difference in serum phosphate as expected from     our sample size calculation   "
125417|NCT01643473|"     The purpose of this study is to to culturally tailor a technology-based individualized     adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are     non-adherent to their medications, and determine its acceptability.   "
125418|NCT01643460|"     The purpose of this study is to track outcomes and complications of patients at IUMC referred     by physicians for EUS-guided pancreatic cyst ablation. This information is essential in order     to disseminate future published information to physicians about this technique. A database     will be created to track these patients undergoing an already scheduled/planned procedure.     Phone calls at selected intervals will be made following the procedure to track any     complications that occur   "
125419|NCT01643447|"     The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it     can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that     Ulinastatin can improve survival in HCC patients or not.   "
125420|NCT01643434|"     Resistant hypertension (ReHy) is an emerging clinical and public health problem which tends     to increase because populations are living longer and there is a growing global epidemic of     obesity, diabetes and sleep apnea. It is also tempting to speculate that the excessive     dietary salt ingestion reported in many countries can contribute substantially to the risk of     ReHy development. ReHy is defined as persistent high blood pressure (above the target goal)     in spite of the use of at least 3 antihypertensive agents of different classes, one of them     must being diuretics.      Data regarding the exact prevalence of ReHy are very limited. In addition, little data is     available about 3-drug combinations but a simplified treatment algorithm has demonstrated     that a combination of a diuretic plus an angiotensin-converting enzyme inhibitors (ACEi) or     an angiotensin-receptor blocker (ARB) plus diuretic, adding a calcium channel blocker when     necessary, controlled 64% of hypertensive patients and, in addition, was even more efficient     than the current guideline-based management. By contrast, the fourth drug to be added-on the     triple regimen is still controversial and guided by empirical choices or personal     preferences. Recent studies suggest the emerging role of spironolactone as the first-line     fourth drug for treating resistant hypertension. Conversely, because of the     pathophysiological rationale, others have proposed the use of β-blockers or even centrally     acting agents for managing the sympathetic hyperactivity. The present concerns about the     limited blood pressure reducing effect of β-blockers, especially in elderly people, the     potent effect of centrally acting agents and our personal experience are pointing to     clonidine as the fourth drug to be added-on to a multidrug combination for reaching optimal     blood pressure in patients with ReHy. Nevertheless, no studies have been performed comparing,     head-to-head, which one is the best fourth drug (spironolactone or clonidine) to be added-on     to a common used multidrug combination in order to treat this condition.      Therefore, the principal objectives of the ReHOT Trial are to assess prospectively: (1) the     prevalence of ReHy in a cohort of outpatients with stage II hypertension; (2) the effect of     spironolactone on blood pressure, in comparison to clonidine, when added to a multidrug     combination consisting of chlorthalidone plus ACEi (or ARB) plus amlodipine, all of 3     up-titrated to the highest dose; (3) the role of measuring sympathetic nervous system     activity and renin-angiotensin-aldosterone activity on predicting the response of blood     pressure to spironolactone and clonidine.   "
125421|NCT01643421|"     The purpose of this study is to determine the effects of a deep inspiration combined to     expiratory positive airway pressure protocol on respiratory function, quality of life,     exercise tolerance and heart rate variability in adults with severe asthma.   "
125690|NCT01639859|"     The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor     foci, of normal peripheral zone, and of normal transition zone in the prostate. Images     obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are     compared to whole-mount histology.   "
125422|NCT01643408|"     This study will utilize Erwinaze via intravenous administration in patients between the ages     of 1 and 30 who have experienced an allergy to their frontline therapy. The study will     determine the proportion of patients with 2 day nadir serum asparaginase activity levels that     are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.   "
125423|NCT01643395|"     The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering     from acute non osteoporotic vertebral compression fracture.      Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to     prevent further collapse.      Our study will compare vertebroplasty versus conservative therapy (brace).   "
125424|NCT01643382|"     Based on multiple prior studies, kidney transplant recipients with diabetes are at higher     risk for poor initial graft function after transplant. Our study is designed to determine if     tight blood sugar control around the time of kidney transplant will improve short term graft     function.   "
125425|NCT01643369|"     Important health benefits of meditation may be conferred as much by what people actually do     and say in their daily lives as by how they self-perceive the effect of training on their     behavior and emotions. To test this hypothesis, and to explore whether specific elements of     meditation (e.g. compassion vs. mindfulness) have different effects on real-world social     behavior, the current project proposes to use the Electronically Activated Recorder (EAR) in     a randomized, longitudinal design to objectively measure whether meditation does indeed make     people behave in happier, kinder and more prosocial ways in their daily lives. This design     will permit an exploratory analysis of how such behavioral transformations might relate to     subjective reports of meditative effects. To accomplish these objectives, 108 medically     healthy adults will be randomized to 8 weeks training in compassion meditation (n=36),     Mindfulness Attention Training (MAT) (n = 36) or to an active control condition consisting of     a health education discussion group (n=36). Prior to randomization and again upon completion     of these interventions, all subjects will participate in an EAR protocol to evaluate the     effect of meditation training on their real-world prosocial and affiliative behavior. Based     on prior research and direct pilot data from 25 participants, prosocial and affiliative     behavior will be assessed as the amount of (1) shown empathy and affection, (2) laughing vs.     sighing, (3) arguing and complaining, (4) time spent interacting with others vs. alone, (5)     meaningful conversations, (6) socially inclusive (i.e. use of we/us) vs. self-focused     (i.e. use of I/me) first person language. Following the first EAR assessment, subjects     will commence 8 weeks of compassion meditation training, MAT, or attendance in the health     discussion group. Following these interventions subjects will participate in EAR monitoring     identical to the initial assessment. To assess whether changes in daily behavior are     sustained over a longer period, all subjects will undergo a final EAR assessment 6 months     following completion of the study interventions. Self-report measures of social integration     and support and behavioral/lifestyle variables that might be associated with EAR outcomes     will be evaluated prior to each EAR assessment and treated as covariates.   "
125426|NCT01643356|"     The study will use a comprehensive behavioral intervention adapted for pregnant women to     change dietary intake, eating behavior and physical activity. The central hypothesis of this     study is that the intervention will reduce excess gestational weight gain and achieve     clinical and metabolic benefits in obese and overweight pregnant women and their infants over     the first year of life.   "
125427|NCT01643343|"     The purpose of this research is to study joint attention. Joint attention plays a critical     role in social and language development in children with and without autism. Joint attention     is the shared attention between a child and another person. This study seeks to set a     standard benchmark of frequency scores for joint attention. Finding a rate of engaging in     joint attention behavior would offer a benchmark for all researchers and practitioners     working with learners with and without autism.   "
125428|NCT01643330|"     The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay     heart failure related hospitalizations in persons with advanced heart failure when added to     their maximal and optimized therapy.   "
125429|NCT01643317|"     Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have shown     a significant reduction in AAA related mortality. In addition, the cost-effectiveness of     screening for AAA in men in the Netherlands has been demonstrated by using a Markov model.     Screening might be even more (cost-) effective if targeted on high risk groups, such as     patients with a particular cardiovascular disease with a known increased risk of having an     AAA.      Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused on     targeted AAA screening to proactively diagnose patients at high risk of having an aneurysm     that eventually may rupture. This pilot project aims to study the value of a screening     protocol in daily practice to detect AAA's in high risk patients.   "
125430|NCT01643304|"     This field based, questionnaire study will document observational data on womens perception     of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the     questionnaire at one occasion.   "
125431|NCT01643291|"     Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment     and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged     anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated     radiation exposure. This investigation will evaluate lumbar punctures performed in the     intraoperative setting by oncologists with ultrasound guidance performed by the     anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that     anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of     attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.   "
125432|NCT01643278|"     This phase I trial studies the side effects and best dose of dasatinib when given together     with ipilimumab in treating patients with gastrointestinal stromal tumors or other sarcomas     that cannot be removed by surgery or have spread to other places in the body. Dasatinib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways by     targeting certain cells. Giving dasatinib together with ipilimumab may be a better treatment     for patients with gastrointestinal stromal tumors or other sarcomas.   "
125433|NCT01643265|"     The purpose of this study will allow us to examine how quickly and to what extent plasma     amino acids levels rise after ingesting a single dose of either whey or albumin protein. The     investigators anticipate that the amino acids from albumin concentrate protein will rise as     quickly and to the same extent as amino acids from whey protein. These findings will help us     to understand the biological availability of these proteins and efficacy of the supplement so     that consumers may be presented with nutritional options.   "
125434|NCT01643252|"     The objectives of this study are to evaluate the safety and efficacy of corneal collagen     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as     compared to placebo in impeding the progression of, and/or reducing, maximum corneal     curvature.   "
125691|NCT01639846|"     To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic     solution in alleviating the signs and symptoms of allergic conjunctivitis   "
125439|NCT01643187|"     The purpose of this study is to measure the impact of a fortified food on the nutritional and     micronutrient status of malnourished children, compared with milk. The changes to be     evaluated include the indicators weight for height, height for age, weight for age, mid-arm     circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic     acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.   "
125440|NCT01643174|"     Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what     variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall     survival?   "
125441|NCT01643161|"     Functional (psychogenic or somatoform) symptoms are commonly observed in neurology clinics.     There is no known empirically validated treatment approach to functional symptoms. Cognitive     Behavioral Therapy (CBT) can be effective, but there are major obstacles to its provision.     The investigators will test the hypothesis that adding a CBT-based guided self-help (GSH) as     compared to treatment as usual (TAU) improves patient outcomes.   "
125442|NCT01643148|"     Objective:      Evaluate body mass index (BMI), leptin, Leptin/adiponectin (L/A) ratio and cancer antigen     (CA) 15-3 together as reliable biomarkers for breast cancer.      Patients:      Consecutive patients aged between 40 - 60 years, with breast disease and informed consent.      Interventions:      Patients' Anthropometric and laboratorial characteristics classified by BMI in the group of     cancer and patients with benign breast disease as well as biochemical tests of leptin,     adiponectin,CA 15-3, hemoglobin, glucose low-density lipoprotein cholesterol (LDLC),     high-density lipoprotein cholesterol (HDLC) levels were obtained as well as a blood sample to     analyze CA 15-3 levels with a electrochemiluminescence immunoassay.      Hypothesis:      Using together leptin, L/A ratio, CA 15-3 and BMI could offer a reliable approach to detect     high risk women to develop breast cancer.   "
125443|NCT01643135|"     Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations     such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few     studies in laminectomy had conflicting results and varying in doses. The objective is to     compare perioperative bleeding in major laminectomy between patients receive doubles doses of     tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).   "
125444|NCT01643122|"     Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the     Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable,     valid and able to detect changes over time in approximately 250 patients with mild, moderate     or severe endometriosis confirmed by laparoscopy.   "
125445|NCT01643109|"     CIMT has shown great promise in helping children and adults regain lost function in a     disabled limb by forcing its use through an intensive motor training program and constraining     the unaffected arm with a cast. However, relatively little is known about the underlying     mechanisms of CIMT in hemiplegic CP. This project will use an integrated translation model to     explore neuroimaging predictors of a positive clinical response to CIMT.   "
125446|NCT01643096|"     The purpose of this study is to determine the effect of Zataria multiflora Boiss and Sumac on     the thermic effect of food, activity of sympathetic - parasympathetic system: comparison     between warm and cold temperament people.   "
125447|NCT01643083|"     Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people     in the community. However, results of current pharmacological treatment on functional     dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been used     in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and     abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst     there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators     test whether rifaximin is also effective in curing post-prandial distress symptoms related to     dyspepsia.   "
125448|NCT01643070|"     To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus     capecitabine, with or without prior induction chemotherapy in patients with locally advanced     or marginally resectable rectal cancer with resectable synchronous liver metastases.   "
125449|NCT01643057|"     The purpose of this study is to explore physiological interventions and biomarkers for Apnea     of Prematurity in newborn infants.   "
125450|NCT01643044|"     The purpose of this study is to lay the ground work for a fully powered clinical trial of a     computer-delivered screener and intervention for alcohol use during pregnancy. The pilot     study will include:        1. Evaluation of the usefulness of handheld devices and anonymous screening for self report          of at-risk alcohol use among pregnant women.        2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the          detection of at-risk drinking in pregnant women.        3. Evaluation of the efficacy of a computer-delivered brief intervention and use of          tailored handouts to supplement the computer-based brief intervention focusing on          alcohol use during pregnancy.   "
125451|NCT01643031|"     In recent years numerous studies have shown that the response of patients to the     anti-platelet drug clopidogrel is widely variable. Furthermore, patients who do not respond     well to the drug (resistant) have been shown to be at increased risk to develop cardiac     events, including myocardial infarction and mortality. It thus seems reasonable to test the     efficacy of the drug (by platelet function tests) and modify treatment accordingly. However,     a large study that examined a strategy of routine testing of clopidogrel response in     thousands of patients (GRAVITAS study) did not show any clinical benefit. This study was     limited, however, by a very low event rate (2.3%), and by the strategy employed to treat     patients with low response (increasing the clopidogrel dose), which is currently known to be     ineffective in many patients with low response. To overcome these limitations the     investigators plan to examine a high risk population - patients with diabetes planned to     undergo coronary angiography - and to treat clopidogrel low responders by switching their     treatment to the potent anti-platelet drug ticagrelor, which has been shown to overcome     clopidogrel low response.      The investigators hypothesize that patients with diabetes and low response to clopidogrel     will benefit clinically from switching therapy to ticagrelor. The main endpoint of the study     will be the risk of myocardial enzyme elevation following percutaneous coronary intervention     (PCI); a marker which has been strongly associated with poor clinical outcome.      The aim of the study is, therefore, to assess whether a strategy of monitoring platelet     function during clopidogrel treatment in patients with diabetes undergoing PCI, and modifying     treatment to ticagrelor in patients with low response, will be associated with reduced risk     of myocardial enzyme release.      The investigators plan to enroll patients with treated diabetes, planned to undergo coronary     angiography. Patients with acute or recent myocardial infarction will be excluded. They will     be tested for response to clopidogrel by the VerifyNow P2Y12 assay (either on chronic     clopidogrel treatment or 12-24 hours after receiving 300 mg clopidogrel). Patients with low     response to clopidogrel (≥ 208 PRU) will be randomized to either continued treatment with     clopidogrel (75 mg/day), or switching of treatment to ticagrelor (90 mg twice a day) for 30     days (followed by continued clopidogrel therapy). The primary endpoint will be the rate of     troponin of CK-MB (cardiac enzymes) measured 20-24 hours after the PCI. Secondary endpoints     will be the occurrence of adverse clinical endpoints - myocardial infarction, need for urgent     revascularization or mortality at 30 days. The investigators aim to enroll 100 patients in     each study group (ticagrelor vs. continued clopidogrel). Assuming a clopidogrel low response     rate of 40% among patients with diabetes, about 500 patients would have to be screened to     identify 200 patients with low response.   "
125452|NCT01643018|"     Echinococcosis in humans is a parasitic tapeworm infection, caused by a larval stage (the     metacestode) of Echinococcus species. The infection can be asymptomatic or severe, causing     extensive organ damage and even death of the patient.      Echinococcosis is one of the most neglected parasitic diseases and the lack of the     prospective randomised studies supports this idea. Development of new drugs and other     treatment modalities receives very little attention, if any. In most developed countries,     Cystic Echinococcosis (CE) is an imported disease of very low incidence and prevalence and is     found almost exclusively in migrants from endemic regions. In endemic regions, predominantly     settings with limited resources, patient numbers are high.      The aim of the hydatid cyst treatment is the death of the parasite and consequently the cure     of the disease. It has to be done with a minimal risk and maximum comfort for the patient,     and always paying attention to avoid complications, secondary hydatidosis, and relapses.      There are several treatment modalities. Of them the most preferred surgical method is     traditional cyst management through a laparotomy incision. Same can be done with laparoscopy.     In the past 15 years significant advances in laparoscopic surgical skills and techniques     combined with explosive advances in laparoscopic technology have encouraged the application     of laparoscopy to the evaluation and treatment of solid organs including the liver. There are     many studies about the laparoscopic treatment of liver hydatid cyst published in the     literature and the feasibility of this procedure has been demonstrated by them. While the     majority of them are case reports or case series, there are some relatively large series     comparing open versus laparoscopic surgery published in the last decade, which all are not     randomized trial.   "
125453|NCT01643005|"     This study seeks to develop, implement, and assess an innovative 15-session couple-based     intervention to be delivered in a group format to young parents that aims to strengthen     relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce HIV/STD     risk (concurrency, number of partners, unprotected sex), strengthen relationships, and     improve parenting among young parenting heterosexual couples.   "
125454|NCT01642992|"     The COBIS II registry is a multi-center, real-world registry of drug-eluting stenting in     coronary bifurcation lesions in South Korea. From 18 major coronary intervention centers in     Korea, a total of 2,873 patients were enrolled in this database between January 2003 and     December 2009.      The aim of the study was to investigate long-term clinical results and predictors of adverse     outcomes after percutaneous coronary intervention with drug-eluting stents for coronary     bifurcation lesions in South Korea.   "
125455|NCT01642979|"     Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is     designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in     patients with classic paroxysmal nocturnal hemoglobinuria.   "
125456|NCT01642966|"     This is a prospective, randomized, single-blind, investigator-initiated, crossover study.     Patients with Acute Coronary Syndrome (ACS) subjected to percutaneous coronary intervention     (PCI), are randomized after informed consent, in a 1:1 ratio to either ticagrelor 90mg x2 or     prasugrel 10mg x1 for 15 days. At Day 15± 2 days, coronary diastolic blood flow velocity in     left anterior descending artery (LAD) is evaluated at baseline (bCBFV) and under 2 min     adenosine infusions (maximal diastolic CBFV- maxCBFV) at gradually increasing doses of     50μg/kg/min, 80μg/kg/min, 110μg/kg/min and 140μg/kg/min with at least 5 min recovery     intervals between infusions. A crossover directly to the alternate treatment is performed     followed by the same evaluation at Day 30±2 days .   "
125457|NCT01642953|"     Study preparation        -  To progress this prospective study, the investigators analyzed the retrospective data of          426 patients who had been managed with conventional critical pathway after gastric          cancer surgery during last 1 year.        -  Through this retrospective analysis, we decided the inclusion criteria which showed          significantly the lower complication rate and shorter hospital stay.      Method for Prospective study        -  Patients who enroll in this prospective study are administered and are supplied a liquid          diet one day before surgery without bowel preparation.        -  After gastric cancer surgery, they start sips of water on postoperative first day, and          they are discharged once they exhibit at least three times soft diet without specific          complaint and had normal clinical status and physical examination.   "
125458|NCT01642940|"     This is a prospective, randomized, single-center, single blind, investigator initiated, two     period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS),     treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected     to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet     reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to     either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the     alternate therapy for an additional 15 days without an intervening washout period.   "
125459|NCT01642927|"     A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and     post Left Ventricular Assist Device (LVAD) patients.   "
125460|NCT01642914|"     The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with     placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This     study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients     who are eligible will be randomized to one of two doses of linaclotide or placebo for 12     weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency,     as well as other abdominal and bowel symptoms of CC.   "
125461|NCT01642901|"     Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture     prevention and the associated morbidity of bed rest and further secondary complications.     Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more     effective than other agents in reducing bone mass resorption and leg fractures in     post-menopausal women, but has not been studied in patients with acute SCI. This will be a     randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after     SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus     placebo within 21 days of an SCI.   "
125583|NCT01641302|"     The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the     potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed     that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with     signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by     ultrasonographic measurement of ONSD during laparoscopic surgery.   "
125462|NCT01642888|"     Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.      The new skin test is named C-Tb. Like the current tuberculin skin test, PPD, the C-Tb test is     injected just under the skin and will, when positive, show redness and/or swelling at the     injection site while a negative test will leave no reactions. The investigators hope that     this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test     e.g. may show a reaction if the person tested is BCG vaccinated.      The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB     disease.      With focus on age, HIV status and CD4 count the following analyses are done (in an overall     perspective):        -  To compare the C-Tb test to a blood test, the QuantiFERON test.        -  To compare the C-Tb test to the PPD test that is currently being used.        -  To assess the safety of the C-Tb test.   "
125463|NCT01642875|"     Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative     complications often preclude or delay adequate oral nutrition and nutritional support may be     required. However, the role of perioperative nutritional supplementation in well-nourished     patients remains controversial.      The purpose of this study is to compare the influence of early enteral and oral nutrition on     postoperative course and complications after pancreatoduodenectomy.      96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral     nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive     standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be     started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated     level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and     oral intake will be advanced as tolerated.   "
125464|NCT01642862|"     The inter- and intra-variability in the pharmacokinetic parameters of different formulations     and doses of simvastatin in healthy subjects and in subjects with celiac disease in remission     will be evaluated. Additionally, baseline values of pharmacokinetic parameters of simvastatin     for both study groups will be determined.   "
125465|NCT01642849|"     This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on     weight loss and other metabolic parameters.      Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity     have been well established. The detrimental effects of obesity on cardiovascular, metabolic     and psychological parameters as well as the excess cost to the national health budget are     astounding. One way of treatment and prevention of obesity has been the use of diet and     exercise. In the absence of well-established superiority of one diet over another, different     scientifically unproven diets are in common use. A palatable diet providing satiety as well     as all essential nutrients may go a long way in treating over-weight individuals. Another     factor has been the long-term adherence to such weight loss regimens, which in general have     been poor. Protein diets have been known to provide greater satiety and reduced energy intake     than carbohydrate diets, but definite long-term studies are sparse. For this study the     investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and     12 on HC diet), and compare their weight loss and changes in metabolic parameters between the     two diets.   "
125466|NCT01642836|"     Stanford Goals is a large-scale, community-based randomized controlled trial of an     innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to     treating overweight and obese children. Primary Research Question: Will a 3-year, innovative,     interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based     intervention to treat overweight and obese children significantly reduce BMI compared to an     enhanced standard care/health and nutrition education active comparison intervention?   "
125467|NCT01642823|"     Many children with the childhood cancer, Retinoblastoma, have surgery to remove the tumor and     sometimes the entire eye. The purpose of this study is to collect the extra tissue from     patients who undergo tumor removal for laboratory experiments that will help us understand     not only what occurs in retinoblastoma cells but also how cells normally function. Some of     these studies will include an evaluation of how cells control the way that genes are     expressed, how cells know to become retinal cells, how cells remain retinal cells, how     cells lose their identity as retinal cells, what changes make retinoblastoma cells different     from normal retinal cells, and what changes make some retinoblastomas worse than others.   "
125468|NCT01642810|"     A recent study published by the Canadian Pain Society estimated the direct health care costs     of chronic pain to be about 6 billion dollars. Over 1/3 of all Canadians reported that they     either missed work or experienced reduced productivity due to chronic pain. Fibromyalgia     Syndrome (FMS)is a condition that affects up to 10% of the Canadian population, many of whom     are still in the prime of their lives. While pain and fatigue are prominent symptoms, FMS     sufferers often experience sleep disturbance, gastrointestinal upset, chronic headache,     memory and thinking problems, and depression. Standard treatments focus on medication and     physical exercise but are not always successful. Acceptance-Based behavioural therapy (ABBT)     is a relatively new approach that has been effective not only in treating mental health     concerns such as anxiety and depression, but also other medical conditions such as diabetes     and chronic pain. A novel ABBT for FMS was developed and pilot tested with a small group of     participants. The results of this preliminary study were promising. Unfortunately, many     people cannot adequately access available treatment due to long wait lists, prohibitive     costs, or time/location constraints. Online treatments may offer improved access to care     without reducing the effectiveness of treatment. Therefore, the ABBT for FMS used in the     pilot study is being adapted to an online format and will be evaluated with a larger group of     participants. A wait-list/control group will be employed to evaluate the effectiveness of the     online treatment as compared with treatment-as-usual. If found effective, this treatment     would offer patients easier access to care at a significantly reduced cost to the health care     system.   "
125469|NCT01642797|"     i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted     mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations     compared to WLE with standard biopsy protocol.      ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with     standard biopsy, can reduce the number of biopsies needed per patient for detection of     gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.      iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric     IM/IN/CA.   "
125471|NCT01642771|"     Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-)     may benefit more from Capecitabine chemotherapy. However, the optimum post-operative adjuvant     Capecitabine chemotherapy regimen has not been determined for Chinese population with     triple-negative breast cancer. Thus it's necessary to conduct a multi-center Phase III     clinical trial to verify efficacy and safety of Capecitabine in the treatment of     triple-negative breast cancer. In this study, a prospective, randomized, open, multi-center     Phase III clinical study was conducted to compare efficacy and safety of sequential Docetaxel     followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and     Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide (XEC) as post-operative     adjuvant chemotherapy in the treatment of triple-negative breast cancer in Chinese     population.   "
125472|NCT01642758|"     Beta thalassemia intermedia syndromes are genetic anemias caused by mutations which reduce     production of beta globin, a major component of adult hemoglobin A, the protein which     delivers oxygen throughout the body. Patients suffer from poor growth, fatigue, heart     failure, endocrine deficiencies, and eventually, many require chronic blood transfusions.     There is no approved therapeutic for the deficiency of beta globin chains in beta     thalassemia.      This trial will study an oral therapeutic which stimulates production of fetal globin, an     alternate type which is produced by all humans, but is normally switched off in infancy. This     type of globin can compensate for the missing protein in beta thalassemia.   "
125473|NCT01642745|"     The study will compare the airway responses to two bronchoconstricting agents, mannitol and     methacholine.   "
125474|NCT01642732|"     The purposes of this study are to:        -  Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be          taken in combination with hormonal and radiation therapy in men with high risk prostate          cancer.        -  Evaluate changes in patient reported quality of life        -  Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which can          be used to identify the progress of a disease or condition, which can help researchers          determine the effect the study treatment has on the tumor. Biomarkers can also help          determine areas for further research.   "
125475|NCT01642719|"     Higher rates of mortality have been found both in short sleepers (< 6 hr/night) and long     sleepers (> 8 hr/night), but there has been little experimental investigation of the effects     of chronic, moderate sleep loss in long or average sleepers. Some scientists argue that older     adults might be particularly vulnerable to negative effects of sleep loss, whereas other     scientists argue that many older adults spend too much time in bed, and that moderate     reduction of time-in-bed could help increase the quality of their sleep, and could even     promote health and longevity, particularly in long sleepers. At 4 sites across the US, we     will conduct a large (200 people), randomized, controlled, 5- year study to examine whether a     1-hour reduction of time spent in bed for 12 weeks has negative or positive effects on     multiple health-related outcomes, including inflammation, sleepiness, body weight, mood,     glucose regulation, quality of life, incidence of illness, and incidence of automobile     accidents in older long sleepers as compared to older average sleepers.   "
125476|NCT01642706|"     B cells are known to play an important role in auto-immune diseases by activating T cells,     secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells     named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis     in mouse models. Bregs have also been identified in humans.   "
125477|NCT01642693|"     The purpose of the study is evaluate the histological changes of the dentinal-pulp complex     and root resorption in maxillary premolars with intrusive orthodontic movement under a low     power laser effects.   "
125478|NCT01642680|"     The number of long-term cancer survivors is growing. As a result, treatment-related morbidity     - such as cardiovascular disease, metabolic syndrome, functional decline and fatigue - is     impacting quality of life and impairing survival. Metabolic syndrome in the general     population is currently treated with lifestyle advice to increase physical activity (PA) and     reduce caloric intake. This approach is still underused as standard care for cancer     survivors. The aim of this study is investigate whether a tailored PA program that starts     early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms     of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular     morbidity to a program that starts late (after completion of chemotherapy).   "
125479|NCT01642667|"     The aim of this study is to elucidate the efficacy and safety of pharmacoinvasive therapy by     using prourokinase (prouk), a unique fibrin-specific agent, in patients with ST-segment     elevation myocardial infarction (STEMI)   "
125480|NCT01642654|"     Objectives:      The purpose of this research was to assess modifications caused by a concurrent water     exercise program on plasma nitrite (NO3), cerebral vascular resistance and cholesterol in the     elderly and analyze the correlations between these variables after intervention.      Methods The sample was composed of 40 women mean age 69,21 ±5,27 years old, divided into an     intervention (WG) and control group (CG). It was to measure nitrite concentration (NO3) by     the Griess reaction; internal cerebral arteries were assessed by Doppler ultrasound to     determine the resistivity index and Cholesterol was determined using the colorimetric     enzymatic method and test kit. Intervention with water exercise program consisted of three     weekly sessions for 16 weeks.   "
125481|NCT01642641|"     The purpose of this study is to determine the most efficient treatment approach (two surgical     and one non-surgical) in the treatment of moderate to severe chronic periodontitis, with     regard to healing and resolution of disease, patient reported outcomes and cost     effectiveness.   "
125493|NCT01642485|"     Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough     electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval,     which may affect pharmacokinetics (PK) and/or pharmacodynamics (PD) of the study drug.     However, there is no published data clarifying this issue. There is also a paucity of data     investigating ethnic differences of the effects of medicines on QTc.      The aims of the study were to compare the effect of different food contents to placebo on the     changes in ECG and to demonstrate the effect of insulin, C-peptide and glucose on the ECG.     This was done by giving different treatments on separate days, which included intravenous     insulin, a high carbohydrate breakfast [>70%], and a calorie reduced low carbohydrate     American FDA standard breakfast. Moxifloxacin 400 mg was used as a positive control and was     given with and without food to Caucasian and Japanese volunteers to investigate racial     differences.   "
125482|NCT01642628|"     Intuitively, the investigators surmise the initial and subsequent viewing of a breast site     following mastectomy may be traumatic. A qualitative study on the experience of viewing self     in the mirror for a woman who has had a mastectomy has confirmed the experience is unique for     each individual, and may well be difficult. This research study aims to determine if these     difficult moments may be buffered by a mirror intervention providing women who are scheduled     for a mastectomy with a hand held mirror, instructions by a Oncology Nurse Navigator (ONN) on     how to use the mirror in initial and subsequent dressing changes, and offering to discuss any     concerns or questions.      The purpose of this study is to evaluate the feasibility of a nursing mirror educational     intervention and determine if it is of potential value for women scheduled for a mastectomy.     Results from this pilot study will help determine whether the research design, setting,     sample, instruments, data collection and data analysis are appropriate and practical for a     larger study.      Hypothesis      Women, ages 18 and over, who have had a mastectomy, and receive a planned pre-operative     education and self-reflection intervention will have relatively improved anxiety, body image,     depression and emotional well-being scores one to three weeks post-operatively as compared to     those who received usual care.   "
125483|NCT01642615|"     The purpose of this study is to assess the safety and effectiveness of treatment with once     daily oral administration of dexlansoprazole delayed-release capsules in adolescents with     erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.   "
125484|NCT01642602|"     The purpose of this study was to assess the safety and effectiveness of once daily oral     administration of dexlansoprazole delayed-release capsules in adolescent participants with     symptomatic non-erosive gastroesophageal reflux disease (GERD).   "
125485|NCT01642589|"     The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in     support of registration of the vaccine in South Korea.      Primary Objective:        -  To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y          and W-135, 28 days after a single dose of Menactra®.      Secondary objectives:        -  To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion          rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine        -  To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.        -  To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers          before and 28 days after a single dose of Menactra® or Adacel® vaccine.   "
125486|NCT01642576|"     This study aims to compare the effects of 8 months of diet modification, with or without     exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and     quality of life in obese men.   "
125487|NCT01642563|"     Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and     severity after transfusion of standard platelets versus platelets prepared with two     commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of     standard versus PRT platelets. The two technologies will be analyzed separately.      Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets     versus incidence in recipients of control (standard) platelets.      Secondary endpoints: time to the first grade 2 or greater bleeding event after the first     study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of     days with grade 2 or greater bleeding during the period of platelet transfusion support;     number of platelet units transfused and total dose of platelets transfused per day of     thrombocytopenic platelet support; proportion of patients with acute transfusion reactions;     post-transfusion platelet count increments      Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization,     frequency of clinical refractoriness to platelet transfusion with demonstrated HLA     alloimmunization, frequency of clinical refractoriness to platelet transfusion that is     persistent during the period of platelet support in the absence of HLA or human platelet     antigen (HPA) alloimmunization      Patients will be evaluated for 4 weeks after randomization.   "
125488|NCT01642550|"     The purpose of this study is to determine if administration of RM-131 is effective in     improving appetite and gastrointestinal symptoms leading to the recovery of patients with     anorexia nervosa in the outpatient setting.   "
125489|NCT01642537|"     The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and     Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of     cardiac tachyarrhythmias.   "
125490|NCT01642524|"     The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present     with an injury to their head which makes them unconscios. The study compares two different     fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are     salt water (standard treatment) versus a higher concentration of salt water mixed with a     sugar (study fluid). The patients have an equal chance of receiving either fluid and the     paramedic and the patient and the treating trauma surgeon do not know which fluid was     provided in the out of hospital setting.   "
125491|NCT01642511|"     In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also     the first-echelon nodal drainage site for metastasis and provides important prognostic     information in breast cancer patients. The internal mammary sentinel lymph node biopsy     (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But     the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is     carried out to improve the visualization rate of IMSLN with modified techniques: (1) The     radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The radiotracer     is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic     guidance.   "
125492|NCT01642498|"     The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in     patients with treatment-resistant hypertension.   "
125494|NCT01642472|"     This is a phase III, multicentre, long-term open-label extension of the phase III study:     Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III     extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month     open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl     extension 2 (PGL11-024).      This proposed study consists of 4 further consecutive courses of 3 months (84 days) open     label ulipristal acetate 10mg once daily treatment each separated by a drug free period.   "
125496|NCT01642446|"     There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with     cirrhotic portal hypertension, While this group of patients are classified as hepatectomy     contraindication according to guidelines from National Comprehensive Cancer Network (NCCN)     and American Association for the Study of Liver Diseases (AASLD). With improvement of     surgical technique, preoperative evaluation, and perioperative management,especially the     Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical     intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal     hypertension.However, most of the previous studies were either retrospective or with small     samples.      The investigators project is a prospective randomized controlled trial, planning to compare     the safety, efficacy and quality of life between precise hepatectomy and combined     interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal     hypertension, to make a further understanding of optimal strategy.   "
125497|NCT01642433|"     The most likely outcome of smoking cessation attempts is relapse, underscoring the need to     advance novel treatments. Preclinical research shows that the noradrenergic system is     critical for modulating drug-seeking behavior and recent findings indicate that the     α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement.     Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An     efficient method for screening novel smoking cessation medications is to integrate human     laboratory paradigms in the context of brief, randomized trials of smoking cessation that     include smokers motivated to quit. This study aims to provide an initial test of prazosin for     smoking cessation by implementing a brief, randomized trial that will include both human     laboratory and clinical phenotypes. This approach will allow an efficient but sensitive     method for medication screening that maximizes clinical validity.   "
125498|NCT01642420|"     Alzheimers disease (AD) is the most common course of cognitive decline and thereby the course     of more than half of all cases of dementia. A proper AD diagnosis is rested on a number of     examinations and tests, which combined can make AD diagnosis likely. But no single test or     examination can unambiguous determine whether the patient has AD or not. Comparatively no     examination or test can with accuracy predict whether a healthy person or a person with only     mild cognitive (MCI)impairment in time will evolve AD.      Quantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT     analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely     available diagnostic methods, which have the potential to diagnose AD at an early stage in a     reliable accurate way. But they also have the potential to predict which patients diagnosed     with MCI have particular risk of developing dementia.      The purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT     analyses and TUG-DT outcome and clinical features in healthy persons as well as patients with     MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which     patients with MCI will in time evolve AD.   "
125499|NCT01642407|"     Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease.     In many patients, the course of PAH is a steady deterioration and reduced life expectancy.      Sildenafil was approved by the European Commission for the treatment of PAH in pediatric     patients in May 2011, making it the first agent to be approved for the treatment of children     with PAH. The approval was based on the largest placebo-controlled study to be conducted in     this population. The recommended dose in pediatric patients aged 1 year to 17 years old is 10     mg TID in patients ≤ 20 kg and 20 mg TID for patients > 20 kg. Higher doses are not     recommended in pediatrics patients.      This study is an open-label, multi-center study to investigate safety, efficacy and     pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH.   "
125500|NCT01642394|"     Main objective:To evaluate the effectiveness of the Diabetes Self-Management Programme     (DSMP) on the metabolic control, cardiovascular risk reduction, quality of life and     self-efficacy in adult patients with type 2 diabetes, compared with current standard care of     patients with type 2 diabetes, in the context of Osakidetza's Primary Care network.      Secondary objectives:        -  To evaluate the impact of the implementation of DSMP in the use of health services.        -  To assess the impact of DSMP in the cost of treatment of the involved population.        -  To evaluate the improvement in physical activity and diet patterns among the          participants.        -  To describe the feasibility of implementing the DSMP in the Basque Country's primary          health care system Methodology: Randomized clinical trial in which patients diagnosed          with type 2 diabetes aged between 18 and 80 years pertaining to 4 primary regions of the          Basque country, who agree to participate in the study, will be randomly assigned to two          groups: the intervention group (the DSMP programme) and the control group. The          intervention will be performed by trained patients with type 2 diabetes and health          professionals and it will consist in 6 group sessions of two and a half hours each, on a          weekly basis with a overall duration of 6 weeks. The session content includes techniques          for dealing with problems, promotion of exercise, nutrition concepts, proper use of          medication, effective communication and basic knowledge about diabetes and its          complications. The sessions are supported with educational material. The main outcome is          the improvement of HbA1c (glycated hemoglobin) levels. Secondary outcomes are reduction          of cardiovascular risk, increase of quality of life and self-efficacy. The results will          be analyzed at 6, 12 and 24 months after the intervention.      Hypothesis: An educational intervention on patients with type 2 diabetes mellitus based on     the program DSMP conducted by previously trained lay persons and health professionals,     improve metabolic control as measured on a 0.5% decrease in Hb A1c (Clar, 2010),compared to     regular health education. On the other hand, it is expected to see improvements in the     quality of life for these patients. The intervention may reduce the weight and cardiovascular     risk due to changes in the physical activity and diet patterns, getting to a more appropriate     use of health services and medication. It is expected that changes in the variables occur 6     months after the intervention and remain over the time   "
125501|NCT01642381|"     The purpose of this study is to investigate the critical components of motivational     interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic     drinking. The study will disaggregate MI into its component parts and test full MI compared     to MI without its directive strategies. This study will test whether the directive elements     of MI are critical or whether MI effects may be attributable solely to its Rogerian,     non-directive components. For more information, go to http://caspirnyc.org/p_motion.html   "
125502|NCT01642368|"     The goal of the Optimum Omega-3 (OO3) Diet Study is to assess whether swapping specific food     ingredients in diets can significantly change omega-3 blood profiles with 10 weeks of a 7-day     menu in men and women (18-40 years old). We want to look at the effect on a person's response     to cognition, satiety and physical fitness. Investigators think that low omega-6 and moderate     omega-3 fatty acid diets may regulate emotional response and help to return to normal after     load carrying activities. We plan to test the effects of improving overall fatty acids on     emotional response, satiety, and physical fitness levels by a diet with an improved omega-3     to omega-6 diet compared to a control diet.   "
125692|NCT01639833|"     The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic     Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in     subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve     replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair,     etc.), or CABG.   "
125503|NCT01642355|"     The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults     to Achieve Cardiovascular Targets) is to determine the best management strategy for patients     undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will     enroll 400 patients post-cardiovascular intervention. The study will compare different     cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult,     and (3) cardiovascular prevention consult with a behavioral intervention program over a     6-month period. The trial hypothesis is that for patients undergoing a cardiovascular     intervention, a prevention consult and behavioral intervention is superior to usual care in     reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary     endpoints include other lipid values, metabolic risk, smoking cessation, physical activity,     nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin     enrollment in the June of 2012.   "
125504|NCT01642342|"     This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion     protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to     people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that     promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk     colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice   "
125505|NCT01642329|"     The purpose of this Registry is creating a database management that allows continuous     monitoring characteristics, evolution, prognostic indicators and management of patients with     ACS admitted in Portuguese Hospitals, and identify the appropriateness of clinical practice     recommendations for diagnosis and treatment of ACS and monitor its evolution.   "
125506|NCT01642316|"     Testing and teaching are completely interrelated in education process; using various kinds of     tests teachers are able to anticipate about the strong and weak points of learning in     students, their progress and their accomplishment. The influence a test on teaching and     learning is commonly referred to as washback. Testing washback is a twisted concept that     becomes even more complex under a various interpretations of the washback phenomenon on     teaching and learning. This study aimed to describe washback behaviors of students, in the     low stakes testing in an ESP environment in two-fold. First, the study investigated the     effects of different formative tests on Iranian medical students' English reading     comprehension achievement. Secondly, the study explores the effects of washback on the     students' attitudes toward English reading comprehension. The pre- and post-tests and one     questionnaire were used to collect the data from Iranian medical students. Data were analyzed     by paired t-test, t-test, and Mann-Whitney U test.   "
125507|NCT01642303|"     Improvement of the internet and its tremendous growth has caused significant progress in     transformation of information. Nowadays in any place of the world and in any time of the day     by accessing through internet every student can use different kinds of information in World     Wide Web which let him to make the best decision what, how and when to study. One of these     educational technologies which are beneficial to learners is vodcast or video recording which     are accessible through the internet.This paper is going to examine the listening     comprehension in EFL learners and whether it may be improved by using vodcasts. So106     language learners of four different classes of Iranian higher intermediate in an English     institute were chosen for this study. These learners were pre-tested by IELTS Listening     Comprehension. Two classes were chosen as subject group which consisted of 54 learners. The     remaining two classes were chosen as control group which consisted of 52 learners. Both     groups were taught Listening Impact book, but students in subject group were provided some     vodcasts based on the topic of their lessons. After 12 weeks of teaching both groups were     post-tested.listening comprehension will be compared using independent t-test and paired     t-test.   "
125508|NCT01642277|"     No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection     (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as     evidenced by routine microbiology cultures. Recent work by the group on the genitourinary     microbiome (GUM) has shown that female urine, even in the absence of culture evidence of     bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine     and sequenced to identify bacterial species present in urine. From this the investigators can     hypothesize that urinary bacteria contribute to urinary symptoms and that there is a     difference in the bacterial communities in the urine of women who respond to Solifenacin, a     drug used to treat OAB, versus those that do not.   "
125509|NCT01642264|"     The primary aim of this study was to develop an interactive Internet-based program     (WeBREATHe: Web-Based Respiratory Education About Tobacco and Health) to train pediatric     respiratory therapists and nurses to provide brief, hospital-based tobacco cessation     interventions to parents of pediatric patients. The WeBREATHe program was based on a Phase I     prototype which was evaluated with 50 pediatric respiratory therapists and nurses.      In Phase II, the investigators redesigned and expanded the program with input from 50     educators, nurses and respiratory therapists from Cincinnati Children's Hospital Medical     Center. Then the investigators evaluated the Phase II program in a randomized trial in which     215 respiratory therapists and nurses from two large, urban children's hospitals were     randomly assigned within hospital to either the Intervention (Training) Condition, or to a     Delayed Treatment (Training) Control condition.      Participants' demographic and tobacco use history were measured at baseline, and tobacco     cessation intervention behaviors, attitudes, knowledge, perceived barriers, and self-efficacy     regarding delivery of a tobacco cessation intervention were measured at baseline, 1 week     post-training, and at 3 months post-training. User satisfaction measures were also collected     at 1 week post-training from Intervention Condition participants. The investigators     hypothesized that participants in the Intervention Condition would have increased tobacco     cessation behaviors, positive attitudes and self-efficacy, and decreased perceived barriers     than participants i the Delayed-Treatment Control Condition.      Following evaluation, the investigators developed a final version of the interactive training     program and created the administrative infrastructure for a marketable product.   "
125618|NCT01640834|"     This study involves taking a single dose of 100 mg or 300 mg LY2409021 or placebo (an     inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug     will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes     a 7 day hospitalization period at the clinical research unit (CRU) and will involve screening     within 30 days of the start of the study as well as telephone consultations within 5 days     after discharge from the CRU.   "
125515|NCT01642186|"     There is no effective standard treatment for fibrolamellar liver cancer that cannot be     removed by surgery. The investigators want to find out what effects, good and/or bad, 3 drugs     called letrozole, leuprolide and everolimus will have on cancer. All of these drugs are FDA     approved for the treatment of different cancers. Letrozole and leuprolide stop the body from     producing estrogen, a normal hormone produced by the body. Too much estrogen may help     fibrolamellar liver cancer grow. Everolimus is a drug that may block other chemicals in the     body that can help cancer grow. The combination of letrozole and leuprolide plus everolimus     may work well together.   "
125516|NCT01642173|"     The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an     integral role in early atherosclerosis, and contributes to the mechanism of coronary     endothelial dysfunction and to the structural and mechanical properties that characterize     plaque vulnerability. Thus, the investigators study will characterize prospectively the     correlation between the functional and structural vascular wall properties, and the activity     of the Lp-PLA2 pathway.   "
125517|NCT01642160|"     Does an internet based text or email interaction and education improve CPAP compliance for     patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.   "
125518|NCT01642147|"     Few studies look into cerebral blood flow (CBF) changes during emergence from general     anesthesia for craniotomy. The purpose of this study is to demonstrate CBF changes during     emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation     of jugular vein bulb and transcranial Doppler.   "
125519|NCT01642134|"     The purpose of this study is to determine the incidence of major vascular events (ischemic or     haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral     anticoagulation or dual antiplatelet therapy) in both arms followed TAVI.   "
125520|NCT01642121|"     This laboratory study is looking into biomarkers in samples from younger patients with acute     myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer   "
125521|NCT01642108|"     Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and insulin     resistance. Studies have shown that most of the populations in which insulin resistance is     considered to be the primary pathogenetic cause of diabetes, have a higher degree of obesity     than those of primary insulin defect. Meanwhile, defective early insulin secretion plays a     predominant role in the non-obese subtype of T2DM which includes majority of Japanese     patients.      Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of     T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1)     and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients with     T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial glucose     concentrations through increases in glucose dependent insulin release and suppression of     inappropriate glucagon secretion. Namely, several mechanistic studies using standardized meal     showed that sitagliptin improved glucose control with decreased glucagon levels and increased     insulin concentration in obese or overweight T2DM patients with BMI > 25 kg/m2. However, how     sitagliptin affects islet function, including glucagon secretion in non-obese patients with     low insulin secretion are not known. Therefore, the investigators will examine the effect of     sitagliptin on glycemic control and the mechanism involved using a standardized test meal in     non-obese Japanese patients with T2DM whose BMI levels are < 25 kg/m2.   "
125522|NCT01642095|"     This laboratory study is looking into biomarkers in samples from younger patients with kidney     cancer. Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors find better ways to treat cancer.   "
125523|NCT01642082|"     This phase II trial studies how well dalantercept works in treating patients with endometrial     cancer that has come back or is persistent. Dalantercept may stop the growth of endometrial     cancer by blocking blood flow to the tumor.   "
125524|NCT01642069|"     This laboratory study is looking into genes in samples from younger patients with acute     megakaryoblastic leukemia (AMKL). Studying samples of blood, tissue, and bone marrow from     patients with cancer in the laboratory may help doctors learn more about changes that occur     in RNA and identify biomarkers related to cancer   "
125693|NCT01639820|"     Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic     lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the     classical surgical treatment including identification of the sentinel nodes, full pelvic     lymph-node dissection and radical hysterectomy.      The experimental arm is only sentinel node identification + radical hysterectomy.   "
125525|NCT01642056|"     Background:        -  Mitochondria are the parts of cells that help produce energy. Metabolism is the process          by which the body uses energy to help cells grow and reproduce. Metabolic and          mitochondrial disorders affect the body s ability to produce and store energy. These          disorders can cause a wide variety of problems, but most often they affect the muscles          and the brain, where energy requirements are high. Treatment is difficult because the          exact source of the problem is hard to detect.        -  EPI-743 is a new drug that is based on vitamin E. Tests have shown that it can help          improve the function of cells with mitochondrial problems. It may be able to treat          people with genetic disorders that affect metabolism and mitochondria.      Objectives:      - To see if EPI-743 can improve energy production and use in people with mitochondrial or     metabolic disorders.      Eligibility:      - Children between 2 and 11 years of age who have metabolic or mitochondrial problems.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  The study will last about 13 months. Participants will have seven 3- to 5-day inpatient          study visits about 3 months apart.        -  Participants will take either EPI-743 or a placebo for the first 6 months of the study.          After 6 months, there will be a 1-month rest period. Then, those who received EPI-743 in          the first 6 months will take the placebo for the next 6 months. Those who had the          placebo will take EPI-743.        -  During each inpatient study visit, participants will have a physical exam. A 24-hour          urine collection will be obtained. Blood samples will also be taken. Imaging studies and          other tests may be performed as directed by the study researchers.   "
125526|NCT01642043|"     Greater trochanteric pain syndrome (GTPS) is a common cause of musculoskeletal pain.      The primary aim of this study is to describe the soft tissue and bony structural ultrasound     (US) findings identified in the lateral hip and iliotibial band (ITB) in patients presenting     with greater trochanteric pain syndrome (GTPS) in an outpatient rheumatology clinic.   "
125585|NCT01641276|"     The propose of this study is to identification of a group of specific amplitude-modulated     frequencies of low intensity electromagnetic fields that is associated with biofeedback upon     exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.   "
125527|NCT01642030|"     Pain is very common in persons with a history of addiction, but few studies have examined the     best treatment of pain in this population. This is a study to determine the pain relief     provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained     on stable doses of methadone or buprenorphine. Experimental sessions will require overnight     stays on a residential research unit. In these sessions, persons will be exposed to standard     experimental pain techniques at baseline and then rate the relief (if any) provided by the     study medication when exposed to the same techniques. Persons will be asked to participate in     2 or 3 sessions, each separated by at least 7 days.   "
125528|NCT01642017|"     This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to     determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly     patients, selected according to the International Society of Geriatric Oncology     (SIOG)classification (Group 2).      It is expected that a total number of 30 patients maximum will be enrolled in the study on 30     months : 18 months accrual - 12 months follow up.      Eligible patients will be enrolled into a standard 3+3 design with a starting dose of     Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels     will be explored.      Toxicity of the schedule will be assessed during the first cycle. Patients will receive study     medication until disease progression. After treatment discontinuation, patients will be     followed during one year.   "
125529|NCT01642004|"     The purpose of the study is to compare the overall survival of BMS-936558 as compared with     Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of     prior platinum-based chemotherapy.   "
125530|NCT01641991|"     A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of     BioThrax® in varying dose regimens with the primary objective of obtaining information on     possible dose-sparing strategies in the event of a major biothreat.   "
125531|NCT01641978|"     The assessment of the level of consciousness in patients admitted to intensive care units     (ICU) can be complicated because the variables that are evaluated can be interpreted in a     different way by different observers.      The main objective is to determine interobserver agreement of the Glasgow Coma Scale (GCS)     among ICU nurses and assess whether professional experience change the results. Secondary     objective: to determine interobserver agreement in each of the three components (motor     response, verbal and eye opening) of the GCS   "
125532|NCT01641965|"     Timing of initiating domiciliary no invasive ventilation (NIV) in amyotrophic lateral     sclerosis patients remains unclear. The hypothesis of the study is that the early use of NIV,     in the initial phase of respiratory muscle weakness, improves the prognosis of ALS patients.      Principal objective: To evaluate the impact of early NIV in the survival of ALS patients.      Secondary objectives:To determine the effects from early NIV in the progression of     respiratory muscle weakness. To analyze the impact of early NIV in the quality of life of ALS     patients. To evaluate the correlation between the FVC and other parameters of respiratory     evaluation (maximal inspiratory pressure (MIP), sniff nasal inspiratory pressure (SNP),     nocturnal desaturation) and their utility in the early indication of the NIV. To evaluate the     tolerance to the early NIV.      Methods: multicentric, randomized, open-label, controlled clinical trial with a parallel     treatment design. Patients will be included when their FVC reaches the threshold of the 75%     of the predicted value and will be randomized in: Group A: the NIV treatment will begin     immediately and Group B: the NIV treatment will be started when patients fulfil at least one     of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45     mmHg. Follow-up visits will be done every three months with pulmonary function test,     nocturnal pulse oximetry, quality of life and quality of sleep tests, assessment of disease     progression (ALSFSR-R scale), tolerance and compliance with NIV.   "
125533|NCT01641952|"     This observational, prospective, multicenter study will evaluate the efficacy and safety of     MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response     or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according     to the current standard and in line with the summary of product characteristics at a dose of     1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.   "
125546|NCT01641783|"     Gastric cancer remains one of the major causes of cancer deaths around the world,especially     in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still     poor, so the investigators urgently need an effective strategy to treat advanced gastric     cancer, however, there was no recommended First-line chemotherapy for advanced gastric     cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab) Paclitaxel     (Abraxane，ABI-007) with high effectiveness and low toxicity had been approved in breast     cancer as first-line chemotherapy in many countries. The investigator then initiated a     prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the first-line     treatment in advanced gastric cancer to observe the efficacy and safety.   "
125547|NCT01641770|"     The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS)     plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe     malnutrition.   "
125534|NCT01641939|"     This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and     safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel)     treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive     advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized     with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram     per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab     emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per     meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per     investigator choice). At the end of the first stage of the study, the dose and schedule of     trastuzumab emtansine that will be used in the second stage of the study will be selected by     an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made     after approximately 100 participants across all three study arms have been treated for at     least 12 weeks.      Once a trastuzumab emtansine regimen has been selected, Stage I participants who were     assigned to the treatment arm which was selected for Stage II of the study and participants     who were in the standard taxane group will continue to receive their assigned treatment     regimen. Stage I participants who were assigned to the regimen that was not selected for     further evaluation will continue to receive their assigned regimen and will continue to be     followed for efficacy and safety. In Stage II of the study, additional participants will be     recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab     emtansine or to the standard taxane therapy. Participants will receive study treatment until     disease progression, unacceptable toxicity, initiation of another cancer therapy or     withdrawal.   "
125535|NCT01641926|"     This study is being done to compare the safety and efficacy of PEG-Intron™ to that of     PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg]     positive or negative) who have not previously been treated with interferon.   "
125537|NCT01641900|"     The investigators will test the hypothesis that the sleep medication, eszopiclone, can     normalize brain activity during sleep and improve memory in patients with schizophrenia. The     investigators will do this by measuring sleep and memory performance on two conditions     separated by one week: taking 3 mg of eszopiclone and taking placebo. The investigators will     study healthy subjects and chronic, medicated outpatients with schizophrenia.   "
125538|NCT01641887|"     The study is to test a decision aid that is designed to help patients make decision regarding     management of their gastroesophageal reflux disease (GERD). Once the decision aid is     constructed we will test and assess the aid on ~100 patients who have GERD to assess     effectiveness.   "
125539|NCT01641874|"     The purpose of the study is to explore if a subgroup of people with osteoarthritic knees can     be identified using the McKenzie System of Mechanical Diagnosis and Therapy.      In the spine this subgroup, termed derangement,has been shown to respond rapidly to specific     directional exercises.      The trial will explore whether these derangements in the knee respond to specific exercises     compared to a control group with no exercises and non-derangement knees given general     exercises.   "
125540|NCT01641861|"     The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison     to the conventional drilling method.   "
125541|NCT01641848|"     The primary objective of this study is to collect preoperative, operative and postoperative     clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total     Ankle Prosthesis.   "
125542|NCT01641835|"     Collect OCT data to evaluate the range and age trend of ocular measurements.   "
125543|NCT01641822|"     The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen     with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in     adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa     (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be     eligible for randomization in the comparative phase if they have not received non-study oral     antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between     Visits 2 and 3, have not developed a condition requiring hospitalization or other change in     clinical status which, in the opinion of the investigator would preclude their ability to     continue in the study, and have demonstrated at least 50% TIS compliance. Participants     enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each     cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28     days.   "
125544|NCT01641809|"     The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral     activity and tolerability in HIV-1 infected, antiretroviral naive subjects.      This study consists of two parts:      Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4     treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of     GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of     open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse     transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either     abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the     Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete     24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1     ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of     virologic rebound) will become eligible for the Maintenance Phase of this study.      Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue     their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily     for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug     ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects     randomized to the EFV arm will continue on their randomized regimen through Week 96.      After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to     continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and     until it is locally approved and commercially available.   "
125545|NCT01641796|"     This is an expanded access treatment protocol designed to provide a topical cream treatment     option to military health care beneficiaries with parasitologically confirmed uncomplicated     Cutaneous Leishmaniasis.   "
125593|NCT01641172|"     Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a     prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These     chemosensory changes are distressing for patients and can lead to changes in appetite, food     choice, and nutrient intake. These changes can result in malnutrition and weight loss.     Possibly, also unhealthy eating patterns can be developed due to these taste and smell     changes, given the high prevalence of obesity among survivors of certain cancer types. The     primary objective is to investigate the nature, prevalence, and duration of taste and smell     changes in patients with disseminated testicular cancer treated with cisplatin based     chemotherapy.   "
125548|NCT01641757|"     Periodontitis is a destructive chronic infection of the gums, ligaments, and bone,     predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at     increased risk of systemic diseases. Increased prevalence of periodontal disease has been     reported in patients with chronic kidney disease, especially in dialysis patients. Chronic     kidney disease (CKD) is the progressive loss of kidney function over time. When kidneys loose     their 85-90 % function, dialysis is performed. Efficacy of dialysis is checked by serum     albumin levels. Lower-than-normal levels of serum albumin may be a sign of kidney diseases.     Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal     failure. A proposed mechanism for the effect of periodontitis on the development of kidney     disease is systemic inflammation. The deleterious effects of systemic inflammation on kidney     function could occur during the period of active periodontal infection and accumulate during     the life time of the individual. This randomized control trial is designed to observe the     effect of non-surgical periodontal therapy on serum albumin levels of patients on maintenance     hemodialysis therapy. Patients will undergo periodontal examination and their serum albumin     levels will be checked. Then they will be randomly divided in two groups. One group will be     given non surgical periodontal treatment and second group will be offered late treatment.     After 6 weeks 1st group will be reevaluated by serum albumin level and periodontal     examination to observe the effect of non-surgical periodontal therapy. Statistical analyses     shall be performed using SPSS software. T tests and Chi-sq tests shall be used to test     differences according to periodontal status for continuous and categorical variables,     respectively. The level of significance is set at p<0.05.   "
125549|NCT01641744|"     The study examines the effectiveness of parent-child Group Attachment Based Intervention     (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting     skills classes. GABI directly addresses the needs of isolated, marginalized families, with     the goals of of enhancing parent coping and resilience, and improving parent-child attachment     relationships.      We hypothesize that compared to usual care, GABI will be associated with improved child,     parent and parent-child outcomes.   "
125550|NCT01641731|"     Induction of oral tolerance in children allergic to cow's milk proteins is not risk-free. The     analysis of factors that may influence the outcome is of utmost importance.      The aim of the study is to analyse the efficacy and safety of the induction phase of oral     tolerance induction according to specific IgE level, as well as adverse events during the     maintenance phase.      Patients allergic to cow's milk are to be included in an oral tolerance induction protocol.     Patients will be grouped according to specific IgE levels in serum (ImmunoCAP) into group I     (sIgE<3.5 kU/L), II (sIgE 3.5-17 kU/L) and III (>17-50kU/L). Allergic children with similar     characteristics will included as a control group. Visits are established at 1, 6 and 12     months after the induction phase. Serum specific IgE levels to cow's milk and its proteins     will be determined at inclusion, and at 6 and 12 months visits after the induction phase.   "
125551|NCT01641718|"     Inguinal hernia repairs belong to the most common surgical procedures worldwide. Increasingly     they are performed using endoscopical techniques (laparoscopy). Many surgeons prefer to cover     the hernia gap with a mesh to prevent recurrence. For it, the mesh must be fixed tightly, but     tension free. During laparoscopic surgery the mesh is fixed commonly with staples or tissue     glue. However, it is not uncommon that staples cause pain at the staple sites while moving.     In addition, staples can cause scarring of the abdominal wall leading to chronic pain.      Aim of the study is to provide evidence that mesh fixation with tissue glue causes less     postoperative pain compared to fixation with staples.      Patients with unilateral inguinal hernia will be randomized to receive either mesh fixation     with tissue glue or staples (ratio 1:1).      Patients with bilateral inguinal hernia will receive mesh fixation with tissue glue on one     side and staple fixation on the other side. The side treated with tissue glue will be     randomized (ratio 1:1).   "
125552|NCT01641705|"     Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology characterized by     peripheral polyarthritis, symmetric, which leads to joint destruction and deformity. It is     estimated that the RA reaches about 0.5% of the population. According to data from DATASUS,     was responsible for 26,671 hospitalizations, 229 deaths and cost exceeding R$ 20 million in     2005-2007.      The main bodily changes are related to joint problems, however, systemic manifestations are     also found in organs such as lung and heart. Although cardiovascular diseases are the most     responsible of the deaths AR, pulmonary complications are common and account for 10% to 15%     of all mortality. Anaya and colleagues point out that the pulmonary involvement contributes     significant morbidity and mortality in these patients. Although pulmonary involvement is a     frequent manifestation in RA, the prevalence and nature of rheumatoid lung disease has not     yet been precisely established. Several lung disorders such as interstitial pulmonary     fibrosis, pulmonary nodules and bronchiolitis may ocorrer1. Laitinen et al point out that     studies of lung function appear to be a valuable helper for radiography in the evaluation of     pulmonary involvement in connective tissue diseases. Previous studies indicate that patients     with RA have an increased incidence of abnormal lung function, according to assessments     including spirometry, lung volume tests and diffusion capacity of carbon monoxide.      Thus, the main objective of this study is to analyze the respiratory mechanics of patients     with RA. Specific objectives were to seek to understand whether a relationship exists between     duration of rheumatoid disease and lung function in these patients.      For this, the investigators used 18 subjects in the control group, free of pulmonary disease     and / or heart, all nonsmokers. In the RA group, a total of 72 patients divided into 4 groups     of 18 volunteers each, classified according to disease duration (0-5 years, 6-10 years, 11-15     years and> or = 16 years). It is noteworthy that all patients in the RA group will also be     non-smokers, since it is already known in the literature that smoking impairs lung function.     All individuals will perform the function test with a trained technician and qualified to     function. The examinations will be conducted: Forced oscillation technique and spirometry, in     that order.   "
125553|NCT01641692|"     This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block     design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with     placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are     currently using non-ICS controller medications. Subjects will participate in the study for up     to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure     adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will     be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment     sequence.      A sub-group of subjects at selected sites (approximately 30% of the total population) will     have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic     sampling at the start and end of each treatment period. Safety assessments will include     monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily     PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic     analysis.   "
125594|NCT01641159|"     The purpose of this study is to evaluate whether or not buspirone is effective in preventing     relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to     enter outpatient treatment upon inpatient/residential discharge.   "
125651|NCT01640392|"     The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife     MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old     African American men who have sex with men (MSM). Specifically, the project will test whether     participants of the MyLife MyStyle program will report at least a 15% absolute decrease in     frequency of unprotected anal sex with male partners at three and six months     post-intervention compared with the wait-list control participants.   "
125554|NCT01641679|"     After initial treatment of differentiated thyroid cancer patients (DTC) are followed by a     blood test, a biomarker called thyroglobulin, in order to detect a possible recurrence.     Nowadays patients are treated 'blindly' with high dose radioactive iodine to treat a     suspected recurrence. However, the scan made after therapy to verify the effect of the     treatment shows that in up to 50% the treatment could be considered as futile.      124I - a radioactive isotope - in combination with whole body PET became recently available     for use in the follow-up of DTC. This could make it possible before the therapy with high     dose radioactive iodine to determine the extensiveness of the disease and whether effect of     the therapy could be expected. Additionally, recurrent DTC lesions that do not accumulate     iodine can be found without the futile treatment with 131I. FDG-PET (another PET modality) is     able to detect these lesions. The value of FDG-PET before 131I treatment however has not been     tested.      The combination of these two diagnostic tools, 124I-PET and FDG-PET, has a potential to allow     earlier and better restaging and selection for treatment   "
125555|NCT01641666|"     This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three     times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg     once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day)     PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C,     Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.   "
125556|NCT01641653|"     This research is being done to investigate if patients who receive a commonly used sedative     drug, known as midazolam, are likely to have high blood sugar levels during the stressful     period during and immediately after surgery. A sedative drug is used to relax a person     without making them sleepy. This drug is also helpful in reducing the memory of the stressful     experience before the anesthesiologists administers anesthesia. Everyone has glucose or sugar     in their blood stream. This sugar gives energy to our organs to allow them to work. Since     high blood sugar levels may be associated with complications like wound infections, the     investigators research is being done to find if patients who receive a sedative medication     prior to their surgical procedure have lower blood sugars during the surgery then a patient     who does not receive the sedation. The investigators would like to know if the administration     of this commonly used drug will help patients maintain a normal glucose level during a     stressful period.   "
125557|NCT01641640|"     This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated     interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with     hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral     response (SVR) 12 weeks after discontinuation of therapy (SVR12).   "
125558|NCT01641627|"     Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy     and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor     tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy. It     requires a stay in follow-up and rehabilitation service, and thus lengthens the duration of     hospitalisation.      Data underline the importance of afferent input integrity in the maintenance of muscle     characteristics and postural control, and suggest that countermeasure programs based on the     stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls.     In particular, fundamental studies performed in rodents by the investigators laboratory have     demonstrated that the adverse structural and functional adaptations which occur during muscle     deconditioning can be counteracted through adequate physiological stimuli such as activation     of proprioceptors. Based on this scientific expertise, the investigators aim is thus to     prevent muscle atrophy and its functional consequences on posture and locomotion, following a     surgical intervention in humans .      The investigators will develop a device allowing stimulation of foot and ankle     proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be     tested on a selected population confined to bed during a post-operative period (knee     replacement). It efficiency will be evaluated by means of three parameters: muscle force of     ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and     balance analysis).      The technique developed in the present project could bring benefits to patients confined to     bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate to     health and quality of life of these patients. In addition, this device might allow to     consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.   "
125559|NCT01641614|"     The purpose of this study is to evaluate the immediately clinic and ultramicroscopic     myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested     heart versus on-pump empty beating heart surgical techniques.   "
125560|NCT01641601|"     This is a randomized study evaluating the impact of pre-hospital cervical ripening with a     transcervical Foley balloon before labor induction in full-term pregnancies on the length of     inpatient labor induction and maternal satisfaction with the labor induction process. The     investigators hypothesize that women who receive pre-hospital cervical ripening will have a     shorter duration of inpatient labor induction as compared to women without pre-hospital     cervical ripening.   "
125561|NCT01641588|"     The aim of this trial has been to explore the effects of self-positioning on cognitive     performance in the work environment using a standardized cognitive test battery to evaluate     executive function under two conditions: sitting and standing.   "
125562|NCT01641575|"     The purpose of the first part of the study is to evaluate the safety, tolerability, and     pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin     given to patients with advanced solid tumors, and to select a dose for further evaluation in     the second part of the study.      The purpose of the second part of the study is to determine the safety, tolerability, and     exploratory clinical activity of gemcitabine elaidate in combination with cisplatin given to     patients with Stage IIIb/IV non-small-cell lung cancer (NSCLC).   "
125571|NCT01641458|"     The fluoropyrimidines 5-fluorouracil (5FU) and capecitabine (Cp) are among the most commonly     used anticancer drugs. Still, there is much controversy about the correct dosing, and the     fact that a minority of patients experience severe, sometimes even lethal toxicity following     treatment. One important factor predisposing patients to severe toxicity is deficiency in the     5FU-catabolic enzyme dihydropyrimidine dehydrogenase (DPD). Our group identified 4 DPD risk     alleles in over 300 Swiss cancer patients, that resulted in a 8-times increased risk of     experiencing severe toxicity from 5FU or Cp. In patients receiving 5FU as a continuous     infusion, there are accumulating data that keeping the AUC of 5FU between 20-30 mg*h/L is     beneficial in terms of treatment toxicity and activity. In this study, patients carrying at     least 1/4 DPD risk alleles will receive a 50% dose reduction of either 5FU or Cp, with the     potential of later dose increases in the abscence of severe toxicity. Additionally, patients     receiving i.v. 5FU will undergo therapeutic drug monitoring at the end of the 2-day     continuous infusion, with subsequent dose adaptations to target a 5FU AUC of 20-30 mg*h/L.     The primary study objective is to reduce the incidence of severe treatment-related toxicity     from 13% (in historical controls) to 5% in study patients.   "
125563|NCT01641562|"     Breast cancer represents the most frequent form of neoplasia in women worldwide, being     responsible of 1.6% of annual deaths. Therefore, it is a major public health issue and     research in this field should be a priority. Taxanes, such as paclitaxel and docetaxel, are     extremely powerful antineoplastic drugs, which alone or in association to anthracyclines,     increase survival and lower the recurrence rate of cancer, but their use is limited by     cardiotoxicity. Cardiotoxicity can appear early or late after therapy, and may vary from     subclinical myocardial dysfunction to irreversible heart failure. Currently, cardiac     dysfunction induced by taxanes is diagnosed through classical echocardiographic parameters.     However, these cannot detect subtle, early changes of cardiac structure and function.     Consequently, description of new parameters, which could detect cardiac dysfunction in an     early stage, becomes essential for detecting the group of patients at risk for irreversible     heart failure. The objectives of the investigators project, in patients with breast cancer     treated with taxanes, are to investigate their mechanisms which lead to cardiac dysfunction,     to describe new parameters for the early diagnosis of cardiotoxicity, and to define     predictive models for cardiotoxicity. Meanwhile, project will publish the results in     prestigious journals, leading to an increase of the visibility of Romanian research     internationally.   "
125642|NCT01640509|"     The purpose of this study is to prove the safety and acceptability of treatment with the     Synchrotron radiation by medium-term medical follow-up of the patients.   "
125564|NCT01641549|"     Malfunction of mechanical heart valves due to clot formation is a potentially devastating     complication. It often results in heart failure, death or stroke. This condition occurs     frequently in patients with mechanical valves in developing countries because they are unable     to monitor and adjust the dose of blood thinning medications. The best treatment modality for     the treatment of patients with this condition is not known. There is no reliable data from     clinical trials to guide treatment and there are no firm guidelines. Treatment with     clot-busting drugs is most commonly used because these drugs (e.g., streptokinase) are     readily available, cheap, and easy to use. However, this treatment is associated with high     rates of treatment-related side-effects (death, life-threatening bleeding and stroke).     Moreover, some recent studies suggest that clot-busting drugs may not be as efficacious in     restoring valve function, as previously believed. Emergency surgery is less often used     because it is more expensive and the required facilities and manpower are not available at     all times at all places. But there is evidence to suggest that surgery results in better     success rates with a lower risk of bleeding and stroke. Well-designed prospective randomised     trials (the gold-standard for reliable evidence) comparing the efficacy, safety and     cost-effectiveness of the two modalities, are needed to help doctors in developing countries     make informed decisions when treating patients with clotted mechanical heart valves. The     investigators propose to perform a randomised controlled trial comparing emergency surgery     with treatment with clot-busting agents in patients with clotted mechanical valves. The study     will be conducted over 4 years at a single, university hospital in a developing country. This     study will determine how often patients who are treated with surgery will be discharged from     hospital, with completely restored valve function, without having suffered a stroke or     life-threatening bleeding, when compared to those who received clot-busting drugs. The     investigators will also find out which of the treatments is safe and cost-effective.   "
125565|NCT01641536|"     This study is an open label, dose escalation study using the classical 3+3 design to     determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA     therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic     hepatitis B patients.   "
125566|NCT01641523|"     Multicenter, prospective, comparative, observational study with regular follow-up visits.      The project's aim is long-term follow-up of patients affected by large and complex     craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial     (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous     bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and     safety among the three treatments.      Elegibility to each treatment will respect the standard clinical practice. Each investigator     will respect his own hospital criteria for cranial reconstruction.      Each centre's agreement to participate the study is totally voluntary.      The study sample size has not been defined on statistical criteria: the study population was     set at 100 consecutive patients treated with cranioplasty reconstruction with one of the     three foreseen group.      Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment     imbalance between centres involved.      Primary study end-points are: evaluation of adverse event incidence after surgical treatment.      Secondary end-points are: quality of life improvement, evaluation of bone continuity     restoration evaluated by CT scan analysis, neurological improvement.   "
125567|NCT01641510|"     The investigators hypothesize that reduced loading dose of prasugrel followed by reduced     maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism     undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24     hours and 30 days later which is associated with major adverse cardiovascular events.   "
125568|NCT01641497|"     Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years     with a endometrial cancer.   "
125569|NCT01641484|"     Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate     is inexplicably close to 30%. However, important volume of those tumors and their hypoxia     degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.      Persistence of tumor hypoxia could be a predictive factor of local control   "
125570|NCT01641471|"     A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain     Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing     pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA). This     will be a placebo-controlled study involving 116 patients undergoing primary unilateral TKA     procedures; 58 patients will be randomly selected to be treated postoperatively with an     active TENS unit and the other 58 patients will be randomly selected to be treated with the     placebo TENS unit (control group). Patients will be enrolled at two sites within the     Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and     control groups will receive a femoral nerve catheter, standard during a primary TKA. It is     hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic     usage, reduce pain, and allow for a quicker return to function following TKA.   "
125572|NCT01641445|"     This study will help to determine whether the medication, topiramate, reduces alcohol use     among adolescents with alcohol dependence. It will also help answer the question, How does     topiramate reduce drinking in teenagers? Understanding how topiramate may reduce drinking in     adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and     help to identify additional medications that may hold promise for improving treatment     outcomes for youth.   "
125614|NCT01640886|"     In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and     methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's     bacteriophage-based diagnostic platform.   "
125573|NCT01641432|"     Problems with attention are a common and debilitating consequence of brain injury. Studies     show that poor attention is the number one predictor of poor cognitive functioning one year     post-injury. This is due to the fact that attention is a necessary component of more complex     cognitive functions such as learning & memory, multi-tasking and problem solving. In many     cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect     syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the     brain is plastic and remodeled throughout life by learning and experience, enabling the     strengthening of cognitive skills or abilities. The investigators own research has shown that     brief, daily computerized cognitive training that is sufficiently challenging, goal-directed     and adaptive enables intact brain structures to restore balance in attention and compensate     for disruptions in cognitive functioning.   "
125574|NCT01641419|"     The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the     duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle     surgery. The investigators also want to find out if there is a difference between 4 and 8 mg     dose of dexamethasone.   "
126849|NCT01624727|"     The purpose of the study is to target inflammation to reduce progression of noncalcified     plaque in the coronary arteries using an intensive lifestyle intervention with omega-3 fatty     acid supplementation compared to standard of care.   "
125575|NCT01641406|"     The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast     carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the     utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype     test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical     anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To     evaluate the prognostic factors associated associated with pathological response as measured     by the residual cancer burden tool.   "
125576|NCT01641393|"     The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as     compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with     Cystic Fibrosis in subjects 12 years of age and older.   "
125577|NCT01641380|"     While there have been major declines in teenage pregnancy around the country, Baltimore,     Maryland has continued to experience increases over the last several years. Access and     adherence to contraception has been found to be a major contributor to declines in teen     pregnancy worldwide. The aim of this proof of concept pilot project is to determine the     feasibility and acceptability of a text messaging reminder system for communicating with     urban adolescents using Depo-Provera for long-acting contraception. We will randomize urban     adolescent girls who have elected Depo-Provera for ongoing contraception to receive either     standard counseling and clinic appointment reminders or a text messaging (DepoTEXT) follow-up     intervention. Participants in the DepoTEXT intervention will receive reminders for clinic     visits and encouraging messages each month for STI prevention. The primary outcomes being     measured are 1) delivery of text messages 2) preliminary effectiveness for improving     adherence 3) patient satisfaction with the text messaging program.   "
125578|NCT01641367|"     The study is being done to:        -  test a strategy of using a resistance test to choose anti-HIV drugs. Resistance tests          look at the HIV in your blood to see which drugs might work best to lower your HIV          infection.        -  see how well combinations of new anti-HIV drugs work to lower HIV infection        -  see if taking new anti-HIV drugs together is safe and tolerable        -  see if text messages improve people's anti-HIV drug-taking behavior (only at sites doing          the adherence study)        -  in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare          how these drugs act in the body        -  in Step 3, to see how people do after they stop having frequent clinic visits as part of          a research study   "
125579|NCT01641354|"     Knock knees or genu valgus necessitates in some children corrective surgery with partial     closure of the growth plate at level of the knee.   "
125580|NCT01641341|"     Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced     randomization and a cross-over to active treatment for placebo treated individuals who do not     respond to the placebo treatment. Data collected will help determine the feasibility of the     study design in primary care offices. Patient outcome data will provide a more precise     estimate of power for a larger, classic randomized trial to determine if such a study can be     reasonably undertaken within primary care practices.      Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS     tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics     (GDx) test on treatment, and 3) observe and track patients' health, quality of life and     clinical outcomes related to IBS during the study period.   "
125581|NCT01641328|"     Mild cognitive impairment (MCI) describes an initial phase of cognitive decline, usually     among older adults, in which a person notices a decline in attention or memory, and performs     worse than normal on cognitive tests of such. People with MCI are more likely to develop     Alzheimer's disease or related dementia than others their same age, and so MCI is thought of     as an early warning sign of progressive cognitive decline.      While some forms of MCI may be brought about by purely genetic causes, other cases may be due     to a withdrawal of cognitive engagement with the world. In these cases, a rigorous program of     cognitive training may be beneficial, halting or reversing symptom progression.      The current study will evaluate a multifaceted cognitive activation program on older adults     with MCI. This group program is intensive, running for 10 weeks, 3 times per week, for a     total of 100 hours of training. Training consists of meditation exercises for broad attention     activation, Tai Chi exercises to integrate cognition with body awareness, and cognitive     training through computerized attention, memory, and problem solving exercise.      Subjective impressions and objective measures of cognitive ability will be measured before     and after the intervention. The investigators will also examine effects on mood and levels of     daily function. Results will be compared to a waitlisted control group. The control group     will subsequently be entered into a home-based version of the program for 10 weeks, with     assessment before and after training, to look at the importance of the group meeting dynamic     in promoting cognitive change.   "
125582|NCT01641315|"     Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to     be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen     with rabies immunoglobulin have never been studied in the aspect that the immunity level     would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This     study would access this subject.   "
125584|NCT01641289|"     Blackwater fever, characterized by intravascular haemolysis and hemoglobinuria, is an     important cause of renal impairment and mortality in severe malaria caused by Plasmodium     falciparum. The largest malaria clinical trials report blackwater incidences of 5-7% in Asian     adults and 4% in African children with severe malaria treated with artesunate or quinine. The     prevalence of blackwater fever in Chittagong, Bangladesh is 15% with associated rates of     renal failure and mortality of 42.9% and 14.2% respectively.      The fundamental characteristic of blackwater fever is the presence of intravascular hemolysis     of both infected and uninfected erythrocytes and release of free haemoglobin. The cytotoxic     free haemoglobin present can cause severe oxidative damage as a result of haem redox cycling     yielding ferric and ferryl heme, which generate radical species that induce lipid     peroxidation and subsequent production of F2-isoprostanes (F2-IsoPs). Evidence suggests that     F2-IsoPs generated by the hemoprotein-catalyzed oxidation of lipids are responsible for the     oxidative damage and vasoconstriction associated with renal injury in haemolytic disorders     and rhabdomyolysis.      A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol is a     potent inhibitor of hemoprotein-catalyzed lipid peroxidation by reducing ferryl heme to its     less toxic ferric state and quenching globin radicals. In a recent proof of concept trial,     paracetamol at therapeutic levels was shown to significantly decrease oxidant kidney injury,     improve renal function and reduce renal damage by inhibiting the hemoprotein-catalyzed lipid     peroxidation in a rat model of rhabdomyolysis-induced renal injury. Since adults with severe     malaria demonstrate increased concentrations of cell-free haemoglobin, and urinary F2-IsoPs,     the investigators hypothesize that this novel inhibitory mechanism of paracetamol may provide     renal protection in this population by reducing the hemoprotein-induced lipid peroxidation.     As there is currently no consensus that exists concerning adequate medical treatment for     blackwater fever, the potential application of this safe and extensively used drug would be     of great benefit.   "
125586|NCT01641263|"     The objective of this study is to evaluate the ability of a behavioral intervention,     cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints,     depression recurrence, and cellular and genomic markers of inflammation in older adults with     sleep complaints who have a prior history of depression. The investigators aim to: 1)     evaluate the effects of CBT-SQ vs. Sleep Seminar (SS) on objective (actigraphy) and     subjective (sleep diary; questionnaire) measures of sleep symptoms over a two-year follow-up;     2) determine the effects of CBT-SQ vs. SS on recurrence of depressive symptoms and depression     episode(s) over a two-year follow-up. The investigators will also secondarily examine the     effects of CBT-SQ vs. SS on cellular and genomic markers of inflammation over a two-year     follow-up, and explore whether markers of inflammation and cytokine genes can explain     variability in the risk of depression recurrence in those older adults receiving CBT-SQ vs.     SS. The present study is highly significant by being the first study, to the investigators     knowledge, to focus on the prevention of depression in community dwelling older adults who     have a history of depression, and by targeting sleep disturbance, a modifiable risk factor to     prevent depression recurrence.   "
125587|NCT01641250|"     This multi-center, open-label study will evaluate the safety, pharmacokinetics,     pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in     patients with acute myelogenous leukemia. In Part A, patients will receive multiple     escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus     up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time     on study treatment is until disease progression or unacceptable toxicity occurs.   "
125588|NCT01641237|"     The proposed study will evaluate the performance of fluoride delivered from a new dentifrice     formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by     testing four dentifrices covering a range of sodium fluoride concentration.   "
125589|NCT01641224|"     The purpose of this study is to test the efficacy and safety of pinaverium and an herbal     medication for irritable bowel syndrome (IBS). Pinaverium has been in many countries, but     there is no randomized, double-blind, large sample size, and placebo-controlled study on this     medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and     contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is     that the two remedies are effective and safe for IBS treatment when tested by modern clinical     standards and criteria.   "
125590|NCT01641211|"     This is a feasibility study to determine whether the Expanding Networks for Latinos through     Community Engagement (ENLaCE) can be used to recruit Latino children into a randomized,     controlled trial (RCT) to improve their asthma medication device technique. Children will be     recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch     device technique videos (experimental group; n=50) or a nutrition video (control group, n=50)     in Spanish or English after a regularly-scheduled medical visit. Children's device technique     will be assessed before and after the visit. Process evaluation data will also be collected.     The investigators hypothesize that children in the intervention group will have better device     technique post-intervention than the control group.   "
125591|NCT01641198|"     Between 1992 and 1996, 58 subjects were enrolled in a randomised, short and long term     superiority single centre prospective clinical trial. Each subject was randomly assigned to     receive 5 mandibular endosseous implants of 3 types (B, SW, SC). All subjects were aged     between 25 and 56 years, were in excellent physical and mental health, non smokers, not     taking any prescribed medication, not suffering from TMJ or facial pain abnormalities and     were treated with complete removable dental prostheses of both jaws for at least one year.     All subjects were skeletal class I intermaxillary relationship and had at least 1 cm of bone     height between the superior and inferior cortical tables as well as at least 6 mm. of     buccal-lingual bone width in the anterior mandibular region between the mental foramina. All     subjects had type 2 and/or type 3 mandibular bone quality in this area and specifically     requested a fixed complete dental prosthesis over the mandibular implants accompanied by a     conventional complete removable maxillary prosthesis. Standardized radiographs of the osseous     healing around the abutment-implant interface were taken at 12 months after prostheses     insertion and are to be taken presently and in future at 15 years or more after prostheses     insertion using the same standardized protocol and equipment. The 3 implant types, B, SW and     SC, are approved and commercially available in North America. They are paralleled, screw     endosseous and are composed of commercially pure titanium. Two of the implant types are     almost identical in design except that one of the implant types (SW) has an acid etched     microtextured surface versus the smooth, machined non acid etched surface of the other (B).     The third implant type (SC) possess a very similar design to the others but its     smooth-surfaced collar is narrower and longer than the smooth surfaced collars of the B and     SW implant types which are identical. The SC implant type also has an acid etched     microtextured surface identical to that of the SW implant.   "
125592|NCT01641185|"     The purpose of this study is to evaluate the safety and feasibility of primary     hypofractionated irradiation of the prostate with carbon ions or protons using the raster     scan technique.   "
125615|NCT01640873|"     This study will assess the initial safety, tolerability, pharmacokinetics, and     pharmacodynamics of MK-8655, after single and multiple daily oral administrations to     participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting     plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.   "
125595|NCT01641146|"     HIV continues to spread among Black men who have sex with men (MSM), but few interventions     target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories     of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk     sexual behaviors; b) negative psychological sequelae (e.g., depressive or posttraumatic     stress disorder (PTSD) symptoms); and c) neurobiological abnormalities in cardiovascular,     neuroendocrine and/or immune systems (e.g., cortisol and norepinephrine), and HIV/AIDS     progression. The purpose of this study was to test an HIV risk reduction intervention, guided     by the Social Learning Theory, the Ecological Model, and the concept of allostatic load, a     composite of the cumulative effects of stress on biological systems including     psychoneuroimmunologic markers. The investigators tested the 6-session Enhanced Sexual Health     Intervention for Men (ES-HIM) on 88 non-gay identifying HIV-positive Black MSMW with     histories of CSA. The outcomes were to reduce high-risk sexual behaviors (i.e., unprotected     anal and vaginal sex and number of sex partners) and negative psychological symptoms of     depression and PTSD. Links between these outcomes and biomarkers of stress were also     explored. Randomization to either the ES-HIM or a health promotion control group occurred     with study participants assessed at baseline, post, 3- and 6-months.   "
125643|NCT01640496|"     The purpose of this study is to test blood and tissue samples of people with Ulcerative     Colitis (UC) to see what effects Vitamin D3 may have on the immune system. This research is     being done because it could lead to the development of new treatment for people with     Inflammatory Bowel Disease (IBD).   "
125596|NCT01641133|"     The primary aim of this study is to assess the reactogenicity of Synflorix™ vaccine and     Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of age with either     Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively. In addition,     this study aims at assessing the safety, reactogenicity, immunogenicity and antibody     persistence (approximately 8-11 months following primary vaccination) of the Synflorix™     vaccine and Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of age with     either Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively. This     study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix™     vaccine when given as a booster dose at 12-15 months of age following primary vaccination at     2 and 4 months of age with either Synflorix™ vaccine or Prevenar 13™ vaccine or Prevenar 13™     and Synflorix™, respectively.   "
125597|NCT01641120|"     The purpose of this study is to evaluate patients' views when injecting Avonex     intramuscularly.   "
125599|NCT01641094|"     Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million     people. The previous standard of care therapy of chronic HCV patients consists of     pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in     only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has     previously proven to offer therapeutic options to previous non-responders to the standard of     care. Although, not all chronic HCV patients benefit from telaprevir and it is still not     known why certain patients are also non-responsive to this triple therapy. In this study we     try to understand why certain patients are also non-responsive to telaprevir, how triple     therapy modulates the responsiveness to IFN-α and what the immunological consequences are of     treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of     HCV-RNA levels.   "
125600|NCT01641081|"     The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol     fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to     moderate asthma.      This study will include a screening visit followed by a 4 month treatment period.   "
125601|NCT01641068|"     The purpose of this study is to examine thinking abilities, mood, and quality of life in     cancer survivors before and after an 8-week group-based memory and thinking skills workshop.     Research participants will include people treated for cancer in the past. Researchers would     like to know if there is a relationship between baseline performance on timed attention and     memory tasks before receiving memory and thinking skills workshop designed to improve     cognition, and performance on such tasks after the workshop.   "
125602|NCT01641055|"     The purpose of this study is to compare the possible health benefits of intake of proteins     and peptides (small proteins) from salmon, herring and cod on glucose tolerance and     inflammatory markers in overweight and obese adults. Overweight and obese subjects often have     reduced glucose tolerance and a chronic low-grade inflammation, and previous findings from a     study on cod proteins suggested that both glucose tolerance and immune function were     improved.   "
125603|NCT01641042|"     The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of     the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease     and compare it to its activity in healthy subjects.   "
125616|NCT01640860|"     This study is designed to determined the feasibility and safety in advanced esophageal cancer     treated with docetaxel and cisplatin cocurrent chemoradiotherapy. The primary end points were     clinical best response and response rate and secondary endpoints were progression free     survival and overall survival.   "
125617|NCT01640847|"     This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in     combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for     patients with painful bone metastases.   "
125604|NCT01641029|"     Pyelonephritis is a serious infection that manifests with fever, back pain, nausea, and     vomiting. In the U.S., it is estimated that there are 20 cases of pyelonephritis per 10,000     annually, with the highest incidence in young women. Escherichia coli (E. coli) causes over     80% of these infections. Over the last two decades, E. coli resistance has emerged to     commonly prescribed antimicrobials, such as ampicillin and trimethoprim-sulfamethoxazole     (TMP/SMX). Most recently, resistance to fluoroquinolones and strains producing     extended-spectrum beta-lactamases (ESBL) have been observed. In order to better understand     the evolution and current state of antibiotic resistance among E. coli urinary tract isolates     so as to better inform treatment decisions, the investigators propose to conduct an     investigation to: a) determine the prevalence of antimicrobial resistance among E. coli     causing acute pyelonephritis in various patient groups, and specifically healthy     community-dwellers with uncomplicated infections, b) determine the specific prevalence of     fluoroquinolone-resistance and ESBL-producing E. coli, and c) determine potential risk     factors for fluoroquinolone and ESBL-producing E. coli infections.   "
125605|NCT01641016|"     The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT) in     the management of HIV-infected young people who have responded well to antiretroviral therapy     (ART) and to determine whether young people with chronic HIV infection undergoing Short-Cycle     Therapy of five days on ART and two days off maintain the same level of viral load     suppression as those on continuous therapy, over 48 weeks.      To assess the advantages and disadvantages of the strategy, the incidence of toxicities,     immunological control, resistance mutations, acceptability, quality of life and adherence to     the randomised strategy will also be compared.      Importantly, because of insufficient data on short-term viral load rebound after stopping ART     in this population, the trial will incorporate an initial pilot phase in selected centres, to     assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles of     participants on the SCT strategy.   "
125606|NCT01641003|"     1. to evaluate insoluble fibrinogen particles (iFP), as a tool for harvesting, growing and          transferring attachment-dependent cancer stem cells and comparing it to the standard          method ( coated plate) .        2. to evaluate whether using iFP for growing CSC can yield better results of isolating and          enriching CSCs from fresh tumors than other conventional methods   "
125780|NCT01638689|"     Healthy males were examined with positron emission tomography (PET) and the radioligand     11C-AZ10419369, before and after administration of a single dose escitalopram. A change in     the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was     hypothesized to reflect a change in serotonin concentration.   "
125607|NCT01640990|"     This study is a single dose evaluation using an open label dose escalating design. Cohort1     will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion     over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5     hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg).     Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2     hours after cessation of the intravenous infusion. PK measurements and measurement of     erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30     minute intervals during the infusion of GW328267X up to and including 1 hour after cessation     of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be     done.      Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in     Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision     to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the     Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1.     It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort     2 will consist of 3 healthy male volunteers and the study procedures for this additional     Cohort will be the same as that described for Cohort 1.   "
125608|NCT01640977|"     The study is a prospective non-concurrent controlled observational evaluation of short-term     operative results. As such, study sites will capture perioperative (through 6-week     postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar     interbody fusion) procedures. After this open experience, these same sites will capture the     corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF     variant was performed. The data from both series of cases will be compiled to identify     similarities and differences between the techniques.   "
125609|NCT01640964|"     The main purpose of this exploratory study was to investigate the effect of serelaxin     (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis     and portal hypertension. Measurements were acquired non-invasively using magnetic resonance     angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein     during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study     part B), to determine the acute haemodynamic response to serelaxin (RLX030).   "
125610|NCT01640951|"     CAIN457A2304E1 is an extension study to two ongoing phase III studies, CAIN457A2304 and     CAIN457A2307 (core studies). This extension study is planned to collect up to two years of     long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval     regimen and the retreatment at start of relapse regimen. All subjects completing Week 52 of     CAIN457A2304 and Week 40 of CAIN457A2307 will be eligible to participate in this extension     study. Week 40 of the CAIN457A2307 study is the end of maintenance visit (EOM) and is     equivalent to the Week 52 (EOM) of the CAIN457A2304 core study. Therefore, all subjects     entering the CAIN457A2304E1 study will have received 52 weeks of treatment in their previous     study / studies. In this extension study, the prefilled syringe (PFS) liquid formulation of     secukinumab will be used.   "
125611|NCT01640925|"     This prospective, randomized, controlled trial will compare the incidence of nosocomial     infections (composite of primary bloodstream infections, catheter-associated urinary tract     infections, ventilator-associated pneumonia, and surgical site infections) that occur in     intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who     receive standard bathing (soap and water or non-medicated cloths).   "
125612|NCT01640912|"     The primary purpose of this study is to evaluate the safety and tolerability of a single     intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that     will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo     on scarring at these incision sites will be evaluated visually and histologically.   "
125613|NCT01640899|"     The aims of this study were to evaluate the effects of insoles on pain, daily activities and     physical activity level, and to investigate the relation between satisfaction with the     insoles and their actual use in individuals with LE pain.   "
125619|NCT01640821|"     The Québec government launched in October 2006 an action plan (PAG) to reduce the prevalence     of overweight and obesity among young people and adults by 2012. One of the five priorities     of the PAG is to improve health services for individuals with weight-related issues. The     development and implementation of sustainable weight-control strategies however remains a     challenge, since weight loss is often regained by the majority of individuals over time.     Health-At-Every-Size (HAES) interventions, which are mainly focusing on health rather that     weight, have been proposed as an interesting alternative for individuals, mainly women, who     are struggling with weight-related issues. Based on the HAES, Choisir de maigrir? (CdM?)     program has been clearly identified by the PAG as one of the actions for improving health     services and Quebec's government has already started a massive dissemination of the CdM?     program in CSSS of Québec. In that context, it becomes imperative to rapidly assess the     effectiveness and readiness of the program for a broad dissemination. The present research     proposal falls directly within the scope of the PAG recommendation and the investigators     general objective is to develop a population-based understanding of the effectiveness of the     CdM? program in Quebec's CSSS by documenting the effects of the program on women's health in     a natural setting.   "
125620|NCT01640808|"     The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in     inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the     disease, with the recurrence-free survival as the primary endpoint, in a multi-center,     randomized, double-blind, placebo-controlled, parallel-group comparison study.   "
125621|NCT01640782|"     Open label, randomised, multicenter, superiority study for efficacy. Patients with     histologically proven adenocarcinoma of the stomach or gastroesophageal junction without     gross or microscopic evidence of residual disease after surgery with curative intent and     fulfilling all the inclusion/exclusion criteria are eligible for this study.   "
125622|NCT01640769|"     Magnetic Resonance Image guided delivery of Left and Right Ventricular Leads to optimal     myocardial targets will result in improved clinical response to CRT using Left Ventricular     remodeling criteria.   "
125623|NCT01640756|"     To establish the safety and performance of the AqueSys Microfistula Implant in eyes with     refractory glaucoma.   "
126887|NCT01624233|"     This study will assess the safety and efficacy of ixekizumab in participants with moderate to     severe psoriasis in Japan.   "
125624|NCT01640743|"     The objective of the study will be to evaluate the effect of different therapeutic     immunosuppressive strategies currently employed in common clinical practice on regulatory T     lymphocytes and to verify the hypothesis that the association of thymoglobulins - mTOR     inhibitors - small doses of Tacrolimus not only represents a safe anti-rejection therapy but     it can also lead to mid-term formation of a high amount of regulatory T cells and,     consequently, a high grade of tolerance.   "
125625|NCT01640730|"     This study is for patients with advanced non small cell lung cancer that has progressed     despite standard of care. The purpose of the study is to see if Kanglaite injection has any     effect on survival.   "
125626|NCT01640717|"     The primary objective is to assess safety and efficacy data of Escherichia coli-derived cPMP     in patients with molybdenum cofactor deficiency (MoCD).   "
125627|NCT01640704|"     Numerous studies have examined potential causes for the racial differences in HTN prevalence     and severity including baseline insulin levels, sympathetic nervous activity, intracellular     calcium levels and intracellular sodium levels.[21-23] However, to our knowledge, there have     been no studies examining the relationship of physician adherence to JNC guidelines to racial     disparities in outcomes from HTN; nor have there been published studies examining the use of     interventions such as computerized decision support tools or case-management to improve JNC     adherence with the goal of reducing racial differences in blood pressure control. The aims of     this study are: 1) To determine if physician's prescribing practices for HTN medications     adhere to JNC guidelines for drug therapy.      2) To determine if there are variations in adherence to JNC guidelines based on patient race.      3) To determine if adherence to JNC guidelines improves blood pressure control. 4) To     determine if the use of computerized medical reminders improves adherence to JNC guidelines.   "
125628|NCT01640691|"     The objectives of this single arm study are to evaluate the immune response and safety     profiles of two injections of an inactivated whole-virion vaccine containing aluminum     hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.   "
125629|NCT01640678|"     Autologous epidermal cell suspension grafting is an effective method of surgical treatment in     vitiligo, which is suitable for treating larger areas with better cosmetic results as     compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita     Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which,     compared to other forms of autologous epidermal cell suspension grafting, is easier in use     showing similar results. Furthermore, the ReCell device needs no laboratory facilities.     Therefore, it is promising for patients with large vitiligo and piebaldism lesions.      Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell suspension     grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser abrasion alone     and no treatment, in patients with piebaldism and stable vitiligo. Secondary: to assess the     practical aspects and patients satisfaction of autologous epidermal cell suspension grafting     with the ReCell device.      Study design: Prospective observer blinded randomized controlled pilot study. Study     population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are under     treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical     Centre University of Amsterdam.      Methods: Three depigmented regions on the trunk or proximal extremities will be randomly     allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser     abrasion, or no treatment. After the transplantation, UV-treatment according to the standard     treatment protocol of the NIPD will be started on all sites and continued for 3 months. Three     and six months after grafting, the percentage of repigmentation of the lesions will be     assessed.   "
125630|NCT01640665|"     The purpose of this study is to find the maximum tolerated dose of the combination of two     drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug     which is used to treat certain cancers. The drug Capecitabine is approved to treat patients     with advanced breast cancer as well as early stage colon cancer.   "
127511|NCT01616056|"     This phase II clinical trial studies how well bandage lenses work in treating patients with     ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and     damage caused by eye graft versus host disease.   "
125631|NCT01640652|"     In this study the investigators are testing a new vaccine against Neisseria meningitidis, the     leading infective cause of childhood death in the UK. This bug (also known as meningococcus)     can infect the lining of the brain (meningitis) or the blood stream (septicaemia) and can     affect all ages, but especially children, adolescents and young adults.      The bug is classified into different groups based on its outer capsule (or shell), and this     study will test a new vaccine to protect against group B meningococcus (MenB) disease, which     is the most common type in the UK.      Vaccines are given to prepare the immune system to fight an infection. Vaccines work by     stimulating the immune system to produce specialised proteins (called antibodies) and white     blood cells designed to kill the bug later in life if needed.      Vaccines against other types of meningococcus have been developed and saved many lives.     However MenB is different because its outer capsule does not stimulate the immune system very     effectively. There is therefore no broadly effective vaccine against MenB disease.   "
125632|NCT01640639|"     Several studies have shown that inflammation and matrix degradation have pathogenic effects     on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the     matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling     process.      The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory     and antioncogenic properties that could be of benefit in case of congestive heart failure     (CHF).      Previous, small investigations have shown an improvement in left ventricular ejection     fraction and a favorable cardiac remodeling during thalidomide therapy.   "
125663|NCT01640236|"     This is a longitudinal Feasibility Study of a novel non-invasive device in assessing     radiation dose exposure in humans. All patients receiving whole body irradiation therapy and     meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements     and slit-lamp examinations on up to eleven occasions starting prior to the first fractional     dose of irradiation.   "
125873|NCT01637480|"     The purpose of this study is to determined if a lower back treatment would change the hip and     knee muscle activities in people with and without anterior knee pain. The investigators     hypothesized that the lower back treatment may change the hip and knee muscle activities in     people with anterior knee pain but not in people without anterior knee pain.   "
125633|NCT01640626|"     There is a sever lack in application of health education intervention for Soil Transmitted     Disease (STH) in rural communities and in school children among Orang Asli in Pahang in     Malaysia, and also there is a lack of information on the effect of different health education     aspects on STH control in Malaysia, so the investigators think that introducing such new     national educational package and for the first time in Malaysian's school will help children     to make some behavior changes specially for the school children aiming to use these children     as an educator agents to their families and preschool brothers and sisters, to build a base     for this issue and to reduce STH intensity in these rural areas, which in turn will determine     the best approach to health education intervention to be applied to other rural areas in     Malaysia.   "
125634|NCT01640613|"     The aim of this study is to describe technique, efficiency, safety and satisfaction of     ultrasound guided intermediate cervical plexus block for carotid endarterectomy.      The investigators present a simple approach for carotid regional anaesthesia by an anterior     way that has not been published yet.   "
125635|NCT01640600|"     The purpose of this project is to conduct a follow-up study with women that had participated     in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink     and Blue Kids Study is a follow-up study with the mothers and also with the children they     were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8     years old, which is a perfect time to look at developmental outcomes in children. This study     will look at children with exposure to nicotine or antidepressants during pregnancy, as well     as children who were not exposed. The investigators hypothesis is that children who were     exposed to either nicotine or antidepressants in pregnancy will have poorer developmental     outcomes than children who were not exposed. The investigators are also interested in     determining whether nicotine exposure or antidepressant exposure results in poorer outcomes.      The investigators specific aims are:        1. To determine whether pre-school and school aged offspring exposed to maternal cigarette          smoking or antidepressants during pregnancy are more likely to have social-emotional          problems compared to children who were not exposed to cigarettes or antidepressants          during pregnancy.        2. To determine whether pre-school and school aged children who were exposed to prenatal          maternal cigarette smoking or antidepressants during pregnancy display cognitive          impairments as compared to children who were not exposed to either prenatal maternal          cigarette smoking or antidepressants.        3. To determine if pre-school and school aged children who were exposed to maternal          prenatal cigarette smoking or antidepressants display impaired motor development as          compared to children who were not exposed to maternal cigarette smoking or          antidepressants in pregnancy.   "
125636|NCT01640587|"     In camps for displaced persons located along the Thai-Myanmar border, mefloquine and     artesunate combination therapy has been used since 1992. In vivo efficacy of a 3 day regimen     of mefloquine + artesunate (MAS3) has been monitored regularly since its introduction in     1992. In 2009 Carrara et al summarised the in vivo PCR-adjusted cure rates at Day 42 and Day     63 in patients treated with MAS3 between 1995 and 2005, as well as the in-vitro parasite     susceptibility to MAS3 during that same period, and the changes in pfmdr1 copy numbers.The     proportion of patients with parasitaemia persisting on day-2 increased significantly from     4.5% before 2001 to 21.9% after 2002 (p<0.001). Delayed parasite clearance was associated     with increased risk of developing gametocytaemia (AOR = 2.29; 95% CI, 2.00-2.69, p = 0.002).     MAS3 efficacy declined slightly but significantly (Hazards ratio 1.13; 95% CI, 1.07-1.19,     p<0.001), although efficacy in 2007 remained well within acceptable limits: 96.5% (95% CI,     91.0-98.7). The proportion of infections caused by parasites with increased pfmdr1 copy     number rose from 30% (12/40) in 1996 to 53% (24/45) in 2006 (p = 0.012, test for trend).      Evidence of reduced susceptibility to artemisinins in Western Cambodia was first reported in     January 2007. Artemisinin resistance was manifest by a marked slowing of parasite clearance.     A more recent analysis of parasite clearance data collected prospectively in patients with     uncomplicated hyperparasitaemic malaria has shown a progressive decline in parasite clearance     rates over the last decade suggesting a decline following the same trajectory as in Western     Cambodia but with a time lag of a few years.      Surveillance data collected in 2011 have shown a dramatic and worrying decline in efficacy of     MAS3, albeit in a small number of patients. This decline in efficacy of mefloquine +     artesunate is likely to be attributable to reduced parasite susceptibility to mefloquine. The     other fixed dose combinations available dihydroartemisinin-piperaquine (DP) is the best     option to replace mefloquine-artesunate since it is thought that it remains effective in the     presence of high pfmdr1 copy numbers. In addition DP is administered once daily and needs no     special dietary modification to ensure adequate absorption.      In this study it is hypothesised that efficacy of DP (estimated to be 95%) will be     significantly higher than that of MAS3 (estimated to be 65%), therefore the investigators     propose to conduct a randomised controlled trial between DP and MAS3 for the treatment of     P.falciparum.   "
125637|NCT01640574|"     In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden     of disease than Plasmodium falciparum (Pf). As control over Pf improves, Pv will assume     increasingly larger percentages of malaria prevalence. The chronicity of Pv, due to the     latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability     and compounds the economic burden of those with symptomatic disease. The only widely     available treatment for hypnozoites is primaquine, which, because of challenges with     tolerability, safety in G6PD deficient persons, and compliance, is not commonly prescribed     for the treatment of Pv. Currently, chloroquine is used for the treatment of the blood stages     of Pv, however, there are concerns about increasing parasite resistance. Alternative     treatments, such as artesunate, should be considered in the future of the treatment of blood     stage Pv. The use of primaquine in the treatment of hypnozoites (radical cure) should be     emphasized so that transmission of Pv can be controlled.      This study aims to determine the optimal primaquine regimen for radical cure of Plasmodium     vivax. Chloroquine is currently the standard of treatment for Plasmodium vivax. Chloroquine     may have synergistic effects when used with primaquine and due to its long half-life may     delay the first relapse of vivax malaria. In contrast, artesunate does not have documented     interactions with primaquine and has a very short half-life, thus, presumably will have no     impact on first relapse. Combining primaquine with these two anti-malarials may lead to an     alternative regimen for Pv infection and changing the primaquine dosing regimen may lead to a     more practical and efficacious therapy.   "
125638|NCT01640561|"     Early childhood (up to age 5 yrs) is a period of dramatic change in the cognitive, emotional,     social, and behavioral domains; children continuously progress by observing and interacting     with the world around them. In the face of economic instability and nutritional, medical and     educational deprivation, HIV-affected very young children are the most vulnerable HIV     subgroup globally because their families are often the most vulnerable, with little margin     for sustaining a favorable developmental milieu for the child. Through strategic caregiver     interventions during this sensitive period of child neurodevelopment, our study findings have     the potential for positively re-directing the developmental trajectories of tens of millions     of HIV-affected children globally.   "
125639|NCT01640548|"     This non-interventional, retrospective, cross sectional chart review study will evaluate the     management of rheumatoid arthritis patients with a biologic in monotherapy. Data from     eligible patients will be collected from the patient's last visit on the prior rheumatoid     arthritis treatment and from the most recent visit for the biological monotherapy.   "
125640|NCT01640535|"     The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast     Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and     Montelukast monotherapies and to compare the safety and tolerability of Concomitant     Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and     Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.   "
125641|NCT01640522|"     The purpose of this study is to test the efficacy of a collaborative care intervention to     manage cancer-related symptoms and improve health related quality of life in patients     diagnosed with hepatobiliary carcinoma.   "
125644|NCT01640483|"     Post-hoc analysis of psychotherapy outcome data suggest that psychodynamic techniques for     Major Depressive Disorder are differentially efficacious dependent on personality traits of     the patient. More specifically, supportive techniques are hypothesized to be more efficacious     for dependent patients, interpretative techniques to be more efficacious for self-critical     patients, and mixed supportive/interpretative techniques to be more efficacious for mixed     dependent/self-critical patients. Moreover, supportive techniques are hypothesized to impact     on depressive symptoms through increased relational capacities while interpretative     techniques impact through increased self-understanding.      These hypotheses are tested in an experimental single case design with three dependent, three     self-critical and three mixed dependent/self-critical depressive patients. These patients go     through a time-limited (50 sessions) experimental treatment which exists of a sequence of     four A phases (control conditions), one B phase (supportive techniques only), one C phase     (interpretative techniques only), and one BC phase (mixed supportive/interpretative     techniques).   "
125645|NCT01640470|"     Many individuals with mobility limitations, especially those who are older and have more     severe impairments, use a combination of assistive devices and personal assistance to meet     their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers,     bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social     participation (basic and instrumental activities of daily living) among these individuals and     may decrease their dependence on human assistance. Although some research has reported     beneficial outcomes of AT use, few studies have used controlled experimental designs.     Furthermore, the results are often difficult to interpret because the AT interventions are     only vaguely described. Another concern is that many individuals receive help from others,     but scant attention has been paid to the impact of AT on caregivers. This neglect produces an     incomplete portrayal of the effect of AT interventions. The proposed study addresses these     deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals     with mobility limitations and on their caregivers. The Assistive Technology Provision,     Updating and Training (ATPUT)intervention involves a detailed in-home assessment of     participants' current AT; the negotiation and implementation of a personal AT plan with the     participants and their caregivers; and the provision of AT devices, non-structural home     modifications, and device training.      Objectives:        1. To determine the efficacy of the Assistive Technology Provision, Updating and Training          intervention for assistance users and for their caregivers.        2. To explore how the intervention is experienced by these individuals and to help explain          the study findings.      General Hypotheses:      The investigators anticipate this intervention will increase the daily activities and social     participation of individuals with mobility limitations; decrease the psychological and     physical demands on caregivers; and reduce the amount of caregiving required.      Methodologies:      This research will use a combination of quantitative and qualitative methods. The     quantitative portion will be an experimental, single-blinded study in which the investigators     randomly assign participants to either the ATPUT or a customary care group.   "
125646|NCT01640457|"     NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and     efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy,     and of the adjacent degenerated disc, if present. The objective of this clinical study is to     provide basis for a confirmatory study design (endpoints, methodologies) (Phase II), and to     develop a safety profile (Phase I). This study further aims at developing and validating     known and new biologic markers for the quality and clinical efficacy of the product as     requested in the context of identity, purity and potency characteristics of the     medicinal/investigational product.   "
125647|NCT01640444|"     The purpose of the study is to explore the influence of BRAF and PIK3K status on the efficacy     of FOLFIRI plus Bevacizumab or Cetuximab, as first line therapy of patients with RAS     wild-type metastatic colorectal carcinoma and < 3 circulating tumor cells   "
125648|NCT01640431|"     The purpose of this study was to compare the efficacy of method Lumbar Segmental     Stabilization and transcutaneous electrical nerve stimulation (TENS) on pain, functional     disability and ability to activate the transversus abdominis (TrA) of individuals with     chronic back pain caused by disc herniation.   "
125649|NCT01640418|"     In this study we would like to find a way to prevent sacral pressure ulcers in high-risk     patients by the use of a Mepilex sacral dressing. The research question we would like to     answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the     prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk     hospitalized patients?   "
125650|NCT01640405|"     The purpose of the study is to evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab     as first line treatment of patients with metastatic colorectal cancer not previously treated     and with three or more circulating tumoral cells.   "
127877|NCT01611259|"     This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus     Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated     Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.   "
125652|NCT01640379|"     The investigators are enrolling 350 young women 13-21years old diagnosed with pelvic     inflammatory disease(PID) in Baltimore and randomize them to receive CHN clinical support     using a single post-PID face-to-face clinical evaluation and SMS communication support during     the 30. The investigators hypothesize that repackaging the recommended CDC-follow-up visit     using a technology-enhanced community health nursing intervention (TECH-N) with integration     of an evidence-based STI prevention curriculum will reduce rates of short-term repeat     infection by improving adherence to PID treatment and reducing unprotected intercourse and be     more cost-effective compared with outpatient standard of care (and hospitalization).   "
125653|NCT01640366|"     The purpose of this study is to see if the use of a single-use negative pressure wound     therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing     complications following breast reduction surgery and to assess the medium-term aesthetic     appearance and quality of the resultant scar,compared with standard of care dressings.   "
125654|NCT01640353|"     The purpose of this study is to evaluate the use of the iFuse Implant System to treat     degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal     separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a     medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally     invasive surgical procedure (one that uses a smaller incision and less damage to the skin and     other tissues than standard surgery). The purpose of implanting the device is to stabilize     and fuse the SI joint.   "
125655|NCT01640340|"     Palonosetron is different from ondansetron because it stays in the body longer and may     prevent nausea and vomiting for a longer period of time than ondansetron. It is standard     practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to     prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these     combinations are commonly used, they have never been compared to each other. The purpose of     this study is to record the amount of nausea and vomiting, and the amount of rescue     medication that is used with these two different anti-emetic regimens   "
125656|NCT01640327|"     This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity     of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg     derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety     and immunogenicity data, in compliance to current EU Guidelines, with the intent of obtaining     marketing approval of the vaccine formulation intended for use prior to the next influenza     season in the Northern Hemisphere.      The antibody response to each influenza vaccine antigen, was measured by hemagglutination     inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization     in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM)     injection of the vaccine was evaluated in compliance with the requirements of the current EU     recommendations for clinical trials related to yearly licensing of influenza vaccines     (CPMP/BWP/214/96).   "
125657|NCT01640314|"     The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection     of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly     subjects and the antibody response to each influenza vaccine antigen, as measured by     hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and     elderly subjects in compliance with the requirements of the current EU recommendations for     clinical trials related to yearly licensing of influenza vaccines.   "
125658|NCT01640301|"     This phase I/II trial studies the side effects of laboratory-treated T cells and to see how     well they work in treating patients with high-risk acute myeloid leukemia (AML),     myelodysplastic syndrome (MDS), or chronic myelogenous leukemia (CML) that has returned after     a period of improvement (relapsed), previously treated with donor stem cell transplant.     Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune     system in different ways and stop cancer cells from growing. Placing a gene that has been     created in the laboratory into a person's T cells may make the body build an immune response     to kill cancer cells.   "
125659|NCT01640288|"     The purpose of this study is to develop and evaluate the usefulness of MRI using inert     perfluorinated gases mixed with oxygen for regional assessment of pulmonary function. The     proposed study seeks to determine regional qualitative and quantitative lung function     information in the context of the clinical trajectory of chronic obstructive pulmonary     disease (COPD) defined by the cross sectional cohort component. In the case of these     perfluorinated (PFx)/oxygen mixtures, the availability of multi-liter quantities allows for     wash-in/wash-out image acquisition and analysis allowing direct measures of gas trapping in a     manner not easily achieved with any existing modality.   "
125660|NCT01640275|"     Previous work in animal models suggests that inhalational anesthetic agents may accelerate     Alzheimer's disease pathogenesis, but it is unclear to what extent this may happen in humans.     Here, the investigators propose to measure Alzheimer's disease-related neural markers in the     cerebrospinal fluid (CSF) of patients exposed to anesthesia while undergoing neurosurgical     procedures that require lumbar drain placement. Patients will be randomized to either receive     inhalation anesthesia with isoflurane or intravenous anesthesia with propofol.      CSF and blood samples will each be collected at the induction of anesthesia, and then again     ten and twenty-four hours later. CSF samples will be assayed for amyloid beta, tau, and other     Alzheimer's disease-associated markers; blood samples will be assayed for serum inflammatory     markers and used for genotyping studies. These studies should clarify the effect of common     anesthetic agents on Alzheimer's disease related neural markers.   "
125669|NCT01640158|"     The primary objective of this study is to evaluate the effects of plasticity-based, adaptive     cognitive remediation on the cognitive abilities, functional status and quality of life of     soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a     mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as     compared to a computer-based control.   "
125694|NCT01639807|"     The purpose of this study is to compare Selective laser trabeculoplasty (SLT) and topical     medications for initial treatment of open-angle glaucoma /Ocular Hypertension based on     intraocular pressure reduction, treatment side effects, quality of life measures and costs in     South Indian Population.   "
127878|NCT01611246|"     The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the     Acclarent Iontophoresis System with Earset (IPSES).   "
125661|NCT01640262|"     Clinical staging of prostate cancer in Denmark is determined solely by digital rectal     examination and sometimes by TRUS, even though the investigators know these examinations are     inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer     will die with their disease and not of their disease, and the different treatment-options may     imply greater side effects, it is important to improve the diagnostic localization and     staging of the tumour for optimal clinical management and therapy selection.      The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new     possibilities and approaches in detection, localization and staging of prostate cancer due to     its high resolution and soft-tissue contrast. mMRI can provide information about the     morphological, metabolic and cellular changes and characterize tissue- and tumour-     vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a     possible tumour and to guide targeted-biopsies towards disease-suspicious areas.     Internationally published data support the rapidly growing use of multiparametric MRI, as     being the most sensitive and specific imaging tool for prostate cancer patients.      While mMRI internationally is a well recognized and accepted method for detection,     localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in     Denmark has never been applied. Therefore, this project is carried out in order to evaluate     the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.   "
125662|NCT01640249|"     The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it     causes any side effects. The study will also measure how much of the study drug gets into the     blood stream and how long it takes the body to get rid of the study drug. The study drug will     be given in the morning or evening with or without a meal.      This is the first time that this study drug is being given to humans. This study is for     research purposes only and is not intended to treat any medical condition.   "
125907|NCT01637038|"     The investigators are trying to evaluate the clinical effect of remote ischemic     postconditioning on liver graft function and postoperative renal function in subjects     undergoing living-donor liver transplantation.   "
125664|NCT01640223|"     The aim this study is the acquisition and management of a data base for the development of     the glycaemic regulation algorithms. This database will integrate the measures of blood     glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of     insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database     will also contain the bolus of insulin injected at meals and the content of meals, the     reduction insulin level during physical activity and the quantification of this physical     activity. A study will also be conducted to compare the pharmacokinetics of a bolus of     insulin identical with the JewelPUMP either the usual pump of the patient.   "
125665|NCT01640210|"     The main objective of the study is to verify the reliability of the solutes volumes issued by     the Debiotech JewelPUMPTM controlled by its remote.      Three clinical sites are participating in this study:        -  CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume          CHARPENTIER, Dr. Sylvia FRANC        -  Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases, Nutrition,          GRENOBLE (38): Pr Pierre-Yves BENHAMOU        -  CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor          Alfred PENFORNIS, Dr. Annie CLERGEOT      The study will be conducted in 20 patients with type 1 diabetes treated by external insulin     pump. Patients will be informed of the study during a screening visit. After signing the     informed consent, they will return to the center where they will wear a JewelPUMPTM     containing saline water, they will use their pumps in parallel. The investigator or nurse     education will form the operation of the JewelPUMPTM and they will be instructed to replicate     the same settings between their usual and JewelPUMPTM pump. The patient will be asked to     complete visual analog scales of satisfaction with their usual treatment and the various     elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a precision     balance to have a form of a base for comparison.      Patients will leave home for a period of about three days, but they will have to come back     every days to the center. They will be asked to collect all events arising (programming     problems to deliver a bolus, hardware failure ...) in a booklet.      At the end of study visit, patients will return to the center where the volumes will be     assessed by the perfused weighed the various components and devices where they will complete     the visual analog scales of satisfaction at endpoint.   "
125666|NCT01640197|"     The effects of chronic resveratrol supplementation have yet to be investigated in healthy     humans. It is hypothesised that the effects will be different to those seen in acute     supplementation. This study will look specifically at cognitive performance, cerebral blood     flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It     is hypothesized that these measures will be affected differently by acute and chronic     supplementation.   "
125667|NCT01640184|"     It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney     disease (CKD) patients who had not succeeded medical therapy and could not get     parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable     alternative treatment that help control secondary hyperparathyroidism in CKD patients     presenting with enlarged parathyroid gland(s) visible at ultrasonography.   "
125668|NCT01640171|"     Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related     macular degeneration, retinal vein occlusion, and diabetic macular edema are being     administered in the United States at increasing rates. A 2010 study showed that in Canada and     the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000     citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal     injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the     four doctors in my retina group administered a total of 6,494 intravitreal injections; in     2010, we administered 5021 intravitreal injections.      Even though intravitreal injections are commonly administered, the optimal method of     anesthetizing the eye prior to injection has yet to be determined. Some physicians use an     anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use     subconjunctival injected anesthetic.      In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the     American Society of Retina Specialists (the largest retina society in the world) asked about     anesthetic methods for administering intravitreal injections, the following response was     given by the 433 respondents:        -  Topical anesthetic drop: 21.48%        -  Topical viscous anesthetic: 23.33%        -  Topical anesthetic & soaked cotton-tip or pledget: 29.79%        -  Subconjunctival injection of anesthetic: 24.02%        -  Other: 1.39%      An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing     optimal anesthetic prior to intravitreal injections. (Prenner 2011).   "
139822|NCT01454505|"     The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A)     and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis     (Stage B).   "
125670|NCT01640145|"     Maintenance of skeletal muscle mass is crucial during lifespan to retain health and     functional autonomy. Sarcopenia, being the loss of muscle mass during aging, is a well-known     phenomenon in the elderly and a major challenge viewed from an individual, and a     socioeconomic point of view. Nevertheless, several studies have proved muscle tissue to be     markedly affected by physical activity and nutritional interventions even at old age.     Recently, a study in young individuals showed that an acute bout of easily tolerated low     intensity exercise can prolong the muscle building effects of a milk protein intake compared     to a non-exercised situation. Therefore, the major aim of the present project is to evaluate,     whether a low intensity exercise regime in conjunction with milk protein supplementation can     induce positive adaptations on parameters related to muscle size and function in elderly.      The study focuses on the acute muscle protein synthesis response to low intensity exercise     and protein supplementation measured with stable isotope tracer techniques. It is     hypothesized that light muscle activity can augment and prolong the effects of protein     feeding.      If a light resistance exercise protocol as investigated in the present project can prove     beneficial, elderly, frail elderly, and individuals undergoing rehabilitation can challenge     sarcopenia in a new and tolerable way.   "
125696|NCT01639781|"     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa     products, red wine, and tea, are associated with decreased cardiovascular mortality and     morbidity. Dietary interventional studies have corroborated this finding and showed that     flavanols can acutely and after sustained ingestion improve surrogate markers of     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event     in the development and progression of cardiovascular disease. Aging is the major     non-modifiable cardiovascular risk factor associated with progressive decline in endothelial     function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols     can counteract age-dependent vascular changes by interacting with key mechanisms, most     prominently endothelial function.   "
127371|NCT01617889|"     The objective is to assess the comparative fat and calcium absorption, and gastrointestinal     (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing     different fat blends.   "
125671|NCT01640119|"     The investigators want to evaluate whether an original action based on the administration of     alkali (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce     mortality due to cardiovascular events.      Methods: This is a proposal of Multicentric, prospective, cohort, randomized, open-label and     controlled study.      The investigators will Randomize 728 patients with Chronic Kidney Disease(CKD) stage 3b     (CKD-3b) and CKD stage 4: 364 of these patients will be included in the study group called     Bicarbonate Group (Bic), in which levels of bicarbonate should be kept > 24 mEq/l; the other     364 patients will included in the Usual Treatment Group (no-Bic).      Results: The aim of the Research Protocol is to demonstrate if that the optimal correction of     uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing     agent, e.g. sodium citrate) reduces renal and cardiovascular mortality.      Conclusions. In conclusion the Work Group of the Conservative Therapy for Chronic Renal     Insufficiency proposes this cohort, randomized, controlled, prospective, multicentric study     to evaluate the effects of correction of acidosis on the progression of the kidney disease     considered as renal death in End-Stage Renal Disease (ESRD) patients.   "
125672|NCT01640106|"     The primary objective of this study is to obtain preliminary (pilot) data regarding the     feasibility of using dietary omega-3 supplementation in children with significant delays in     language skills; a related secondary objective is to compare adherence to a dosage schedule     of two easy-to-take formulations. A tertiary objective of this study is to collect     preliminary (pilot) data pre- and post-supplementation to identify potential improvement of     skills in a specific area of language development.   "
125673|NCT01640093|"     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the     medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet     formulations compared with the current commercial abiraterone acetate tablet formulation in     healthy male participants, under fasted conditions, at a single dose of 1000 mg.   "
125674|NCT01640080|"     The purpose of this study is to assess the efficacy of esketamine compared with placebo in     improving symptoms of depression in patients with treatment resistant depression.   "
125675|NCT01640067|"     Primary aim of the trial        1. to verify safety and tolerability of expanded human fetal neural stem cells        2. to verify safety and tolerability of a microsurgery human fetal neural stem cells          transplantation model        3. to recognize each change in patient's quality of life      Secondary aim of the trial        1. assessment of the impact of human neural stem cells transplantation on the disability of          ALS in a clinically significant and measurable way        2. Assessment of the impact of human neural stem cells transplantation on mortality (all          causes)   "
125676|NCT01640054|"     The purpose of this study is to evaluate the long term safety and tolerability of     fostamatinib in patients in Asia with rheumatoid arthritis (RA).   "
125677|NCT01640041|"     The purpose of this study is to test an innovative, advanced FNS microstimulator technology     developed by the Alfred Mann Foundation (Santa Clarita, CA) called, the Radio Frequency     Microstimulation (RFM) Gait System that promises to provide FNS training for restoration of     functional gait components in a manner at least as efficacious as current investigational FNS     systems. The design features of the RFM Gait System are intended to address the problems with     the current FNS systems. The RFM implant devices are small enough to be inserted using only a     5 mm incision[3]. Because both the electrode (anode and cathode) are contained within the     microstimulator, there are no lead wires traversing the skin, joints, or torso/limb     junctures. Individual RFMs can be inserted at the motor points and nerves of each of the     paretic muscles in the involved limb and coordinated using radio frequency technology.   "
125678|NCT01640028|"     The purpose of this study is to analyze the relationship between sebum excretion rate and the     following factors:        -  Hormone levels (testosterone, dehydroepiandrosterone sulfate)        -  Expression of 5-α-reductase type 1 (a protein in sebaceous glands that transforms a          hormone (testosterone) into another one that strongly stimulates sebum production)        -  Diet        -  Sun and ultraviolet light exposure.        -  Facial washing routine        -  Sleep patterns (time when you start sleeping and total sleep time)      This study will analyze the relationship between sebum excretion rate and the various factors     that may influence it in approximately 40 subjects. It will be conducted in one center     located in Montreal. All devices are known and have already been used in the past.   "
125679|NCT01640015|"     The primary purpose of this study is to identify the effect of meal frequency on blood     pressure (BP) levels of individuals.   "
125680|NCT01640002|"     It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide     to treat overactive bladder (OAB) in HTLV 1 infected patients.      We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency     in sixty percent.   "
125681|NCT01639989|"     In this study we will try to show that performing Doppler of the Spiral arteries is doable.     No outcome will be followed at this stage   "
125682|NCT01639976|"     Testing the whether Doppler studies after cytotec treatment can predict success of treatment.   "
125683|NCT01639950|"     Background:      - Assessing pain levels is important to improve treatments for different illnesses. Most pain     rating scales are used to determine pain levels in adults. Pain is also a common symptom     among children who have cancer. Those who have genetic conditions that may lead to cancer may     also have pain symptoms. However, the pain scales used for adults have not been fully tested     in children and young adults. As a result, they may not be as accurate. Researchers want to     test pain rating scales in children and young adults who have cancer and genetic conditions     that can lead to cancer.      Objectives:      - To study the effectiveness of pain rating scales given to children and young adults with     cancer and related genetic conditions.      Eligibility:        -  Children, adolescents, and young adults between 18 and 34 years of age who have cancer          or other genetic conditions that can lead to cancer.        -  Parents of participating children will also be eligible.      Design:        -  Participants with cancer or related genetic conditions will fill out four          questionnaires. These questionnaires will ask about pain levels and how much pain          interferes with daily life.        -  Parents will fill out two questionnaires about their child s pain levels and how much          pain interferes with the child s life.        -  Pain treatments will not be provided as part of this study.   "
125684|NCT01639937|"     Background:      - People with congenital heart disease may develop heart failure earlier that those who do     not have the disease. One theory to explain this is that the heart s own blood supply may be     different in people with congenital heart disease. Problems with this blood supply can     severely damage the heart. This damage can be studied with a heart imaging test called a     cardiac magnetic resonance imaging (MRI) scan. Researchers want to use this type of scan to     look at the blood supply to the heart in people with congenital heart disease.      Objectives:      - To learn more about the blood supply to the heart in people with congenital heart disease.      Eligibility:      - Individuals at least 18 years of age who have heart defects caused by congenital heart     disease.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have a cardiac MRI scan to look at the blood flow to the heart.        -  Participants will also have a heart stress test to measure heart function during          exercise.        -  Other imaging studies of the heart may be performed to collect more information on heart          function.   "
125685|NCT01639924|"     Background:      - Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There     are many different kinds of these diseases. Clinical trials are being developed to study new     ways to treat them. People who are interested in clinical trials need to be screened before     they can take part in the studies. Researchers want to evaluate people with different stomach     and intestine disorders to see if they are eligible for clinical trials.      Objectives:      - To study people who have gastrointestinal disorders and see if they are eligible for     clinical trials.      Eligibility:      - Individuals at least 18 years of age who have or may have a gastrointestinal disorder.      Design:        -  Participants will be screened with a physical exam and medical history. Blood, urine,          and stool samples will be collected. Imaging studies such as x-rays and ultrasound will          check to see if the disorder has affected other organs.        -  Participants may have tests as needed depending on their disorder. These tests include          the following:        -  Colonoscopy and endoscopy of the large intestine, esophagus, and stomach.        -  Stomach acid analysis to look at stomach pH levels.        -  Wireless capsule endoscopy to take pictures of the small intestine.        -  Hydrogen breath testing to study issues like bloating, diarrhea, and constipation.        -  Sitz Marker Study to see how fast stool moves through the colon.        -  Participants may donate extra blood, urine, or stool samples for study. They may also          donate stomach contents or tissue from the gut.        -  Treatment will not be provided as part of this study. However, participants may be          admitted to other clinical trials.   "
125686|NCT01639911|"     This phase I trial using the EffTox design will evaluate activity and safety of alisertib, an     Aurora A kinase inhibitor, when given in combination with the selective VEGFR inhibitor     pazopanib in patients with advanced, previously treated non-hematologic solid tumors.   "
125687|NCT01639898|"     POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma     cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs.     Lenalidomide appears to be particularly efficient in this pathology.      The investigators propose a phase II multicentre protocol, based on the use of lenalidomide     combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or     resistant or in relapse.      Patients who can be treated by local radiation or intensive treatment with stem cell support     will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before     radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the     Len-Dex combination (Group 2).      A biological study is coupled with this clinical protocol in order to define the best     biological markers predicting clinical responses, to better understand the POEMS     pathophysiological mechanisms and to set up a bank of samples which can be used to study this     rare pathology.   "
125688|NCT01639885|"     This study investigates the feasibility and immunogenicity of the triple combination of     gemcitabine, Peg-Intron and p53 SLP vaccination in patients with platinum-resistant ovarian     cancer.   "
125689|NCT01639872|"     Many individuals with schizophrenia also suffer from marijuana addiction that worsens their     problems related to schizophrenia. Most of the medications prescribed for schizophrenia have     no effect on reducing marijuana use. Preliminary data suggests that clozapine, an atypical     antipsychotic, may limit marijuana use in people diagnosed with schizophrenia, but it is not     commonly used due to its side effects and is reserved for people who do not respond to other     antipsychotic medications.      In the proposed study, 132 individuals who are diagnosed with both schizophrenia and a     cannabis use disorder will be randomized to a 12-week treatment course with either clozapine     or risperidone (another commonly prescribed antipsychotic medication) to test the hypothesis     that patient treated with clozapine will have decreased cannabis use as compared to patients     treated with risperidone.      Should this study indicate that clozapine will lessen marijuana use in persons diagnosed with     schizophrenia more than risperidone, it will provide evidence needed to begin to shift     clinical practice toward its use in this population.   "
125695|NCT01639794|"     This is an observational study which will look at the improvement in Lower Urinary Tract     Symptoms (LUTS) in Irish men being treated with Vesitirim™ (solifenacin).      Vesitirim™ is a competitive specific muscarinic receptor antagonist and has been used     extensively for the treatment of OAB (Over Active Bladder) in women and has shown significant     impact on urgency, frequency and incontinence in females. It is also indicated for the     symptomatic treatment of urgency incontinence and/or increased urinary frequency and urgency     in men. The purpose of this study is to evaluate LUTS storage symptom improvement in men with     non neurogenic LUTS who have been prescribed Vesitirim™.      The effect of Vesitirim (solifenacin) treatment on bothersome symptoms improvement will be     measured using Over Active Bladder-q Short Form (OAB-qSF) and the Perception of Treatment     Satisfaction (TS-VAS). The study will also help define some of the characteristics of the     male population in Ireland who are treated with Vesitirim™ (solifenacin) as well as     evaluating the effect of Vesitirim™ monotherapy or combination therapy on storage symptoms     improvement (urgency, frequency and urge incontinence) using a bladder diary and IPSS     (International Prostate Symptom Score). The study will also evaluate the effect of Vesitirim™     monotherapy or combination therapy on nocturia using IPSS. The impact of LUTS on quality of     life will also be assessed. Data will also be collected regarding adverse drug reactions.   "
125697|NCT01639768|"     The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based     on reduction of upper airways reactivity after 5 months of treatment with different dosages     of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be     assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch     compared to placebo.   "
125698|NCT01639755|"     The purpose of this study is to obtain clinical experience with the use of new texture,     shaped breast implants in bilateral primary breast augmentation.   "
125699|NCT01639742|"     The purpose of this study is to obtain clinical experience with the use of new texture, round     breast implants in bilateral primary breast augmentation.   "
125700|NCT01639729|"     Determine whether the amount of drug absorbed is different if the tablet is placed under the     tongue, placed between the cheek and gum, or swallowed.   "
125701|NCT01639716|"     The investigators hypothesized that Non Hodgkin lymphoma is using T helper 2 pathways. So     that the investigators decided to study of cytokines related to T helper 2 pathways. It is     well known that parasites and allergic situations also use T helper 2 pathways. Because that     the investigators excluded the patients have parasites and allergic situations. All the     patients were over 18. The investigators included the patients with non Hodgkin lymphoma     which new diagnosed. It is observational study. The investigators took blood before     chemotherapy and four months later. The investigators did not interfere with which     chemotherapy will be given to patients. This decision was belong to hematologist or     oncologist who will treat the patient.   "
125702|NCT01639703|"     The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT     perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC)     and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the     aim to cover the entire liver.   "
125703|NCT01639690|"     The patient has inherited ß-thalassemia major through the genes. These genes have mistakes in     them, so the body cannot make normal red blood cells. Stem cells are made in the bone marrow.     They are the earliest form of blood cells.      This study is being done to see if the investigators can make the stem cells produce normal     red blood cells and hemoglobin. The investigators do this by collecting the stem cells. The     genes with mistakes are removed from the cells. These cells are then treated so they have the     corrected gene for making normal hemoglobin. These treated cells are given back to the     patient through an injection (shot) in the vein. This is also known as gene transfer. In     order for the body to accept these cells, the patient will need to receive a low dose of a     drug called busulfan. It is a drug that will prepare the body to receive the new stem cells.      This study will let the investigators know:        -  If it is safe to give the patient the treated stem cells        -  If the treated stem cells will go into the bone marrow without causing side effects.      Gene transfer has been used for the past five years. It has been successful in treating many     blood disorders. At least 20 patients have received the type of treatment that the patient     will get on this study. This treatment for B-thalassemia major was developed here at Memorial     Sloan Kettering (MSK). It was studied for a long time in the lab before being given to     patients.   "
125704|NCT01639677|"     This is a randomized clinical trial assessing the outcome of two surgical strategies to treat     severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss     and weight loss maintenance but other factors as body composition, eating pattern, metabolic     normalisation, energy expenditure will also be assessed.   "
125705|NCT01639664|"     The study objective is to clarify whether the application of high doses CPFA (coupled     plasma-filtration adsorption) in addition to the current clinical practice is able to reduce     hospital mortality in septic shock patients in intensive care unit (ICU).   "
125715|NCT01639534|"     The purpose of the study is to determine if a new blood test can help the doctor determine if     there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain.     In this study the investigators are analyzing your blood for a new test that might help     doctors decide if symptoms are from a neurologic problem.   "
125775|NCT01638754|"     Patients with heart failure and cardiomyopathy that have been referred for Cardiac     Resynchronization Therapy (CRT) will have their CRT devices implanted using an image guided     treatment plan for optimal lead delivery. The validation of image-guided CRT lead delivery     will significantly advance the field of heart failure therapy.   "
125706|NCT01639651|"     For many years researchers have been documented that the shoulder of the throwing athlete     acquires a increase in external rotation of the dominant limb compared to the contralateral     side.This fact is followed with a loss of the internal rotation of the shoulder, which is     related with a higher rate of injuries in this joint and it´s known as Glenohumeral Internal     Rotation Deficit (GIRD).      Among the approaches for this condition the literature is inconclusive due to the low     methodological quality of clinical trials made,however, the manual therapy has been used with     success to relief the pain and restore the range of motion.      The purpose of this study is to analyse the effectiveness of a mobilization with movement     technique to improve the internal rotation of the shoulder in throwing athletes with GIRD.      It will be a randomized controlled trial with the CONSORT bases with 40 participants that     will be divided into two groups:        -  Control group that will be submitted for an evaluation of shoulder range of motion          (internal/external rotation)of both limbs, upper limb active movements to warm-up (five          minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and          revaluation immediately post-intervention and four weeks post-intervention.        -  Mobilization group that will be submitted for an evaluation of shoulder range of motion          (internal/external rotation)of both limbs, upper limb active movements to warm-up(five          minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds)          plus a mobilization with movement technique to improve internal rotation of the dominant          shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and          four weeks post-intervention.      To evaluate the range of movement it will be use a standard goniometer with an attached     customizes bubble inclinometer to ensure proper perpendicular alignment of the goniometer to     the ground.      The investigators hypothesis is that both group will have improvements in the internal     rotation of the dominant shoulder, however, the mobilization group will have a statistically     significant difference compared to control group immediately post-intervention. Four weeks     post-intervention this difference will equalize, because of the only intervention applied.      Results will be expressed as hazard ratios (HR) with their respective confidence intervals at     95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0   "
125745|NCT01639144|"     The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing     incision helps prevent infection and slow wound healing.   "
125746|NCT01639131|"     Determine the efficacy of combination Gemcitabine and Docetaxel chemotherapy in the treatment     of metastatic colorectal cancer with CHFR and/or Microsatellite Instability (MSI) phenotype.   "
125807|NCT01638338|"     The project aims to develop a new approach to risky drinkers by providing a facilitated     website access and creating a local integrated support network.      In order to do so:      1) A non inferiority-randomised controlled study will be performed to test the hypothesis     that: Brief intervention for risky drinkers delivered in primary care through facilitated     access to an alcohol reduction website has non inferior outcomes to face to face brief     intervention.   "
125707|NCT01639638|"     Treatment is considered successful if the difference in the response in the reduction of the     affected area is above 30% for any of the doses compared to placebo Patients will be     randomised to 1 of 3 treatment arms        1. Placebo        2. CIGB-300 - 5 mg        3. CIGB-300 - 15 mg      A two week screening visit will take place to assess patient eligibility, at least 2 to 5     target lesions (area of the lesion between 20 to 80 mm2), should be identified. Patients     included in the study will be randomly assigned to one of three study arms. Treatment     consists of 3 perilesional applications at the base of the target lesion every 48 hours with     a window of ±24hs.      After each application the potential local and systemic adverse events will be identified and     monitored.      After the last application is made, weekly clinical evaluations for 3 weeks and then every     two weeks, until week 12 will take place. At this time, clinical assessment of efficacy will     be carried out that will define the response to treatment.      After this visit, patients will be followed every 3 months until one year after the last     treatment has been completed to confirm response and long-term security of the CIGB-300     application.      At screening, at 2 and 8 weeks as well as at 6 and 12 months post-treatment blood studies     will be conducted to assess the safety from the systemic point of view.   "
125708|NCT01639625|"     They include patients who are candidates to complete concurrent treatment with endocavitary     brachytherapy External radiation therapy + more QT based weekly cisplatin.   "
125709|NCT01639612|"     1. Purpose of the Study - This protocol aims to demonstrate the feasibility and safety of     autologous ALD-451 cells administered intravenously in World Health Organization (WHO) grade     IV malignant glioma patients following surgery, radiation therapy and temozolomide; as well     as to obtain an initial description of the effects of ALD-451 cells on neuro-cognition     allowing the design of a subsequent phase 2 trial of this intervention in patients with     malignant glioma. The primary objective of this study is to demonstrate the safety of     intravenously administered autologous bone marrow derived ALD-451 cells in the brain     following surgery, radiation therapy and temozolomide in patients with WHO grade IV malignant     glioma. The secondary objective of this study is to determine the recovery of ALD-451 from     bone marrow of patients following radiation therapy and temozolomide. The exploratory     objective of this study is to determine if intravenous administration of autologous ALD-451     cells following surgery, radiation therapy and temozolomide in WHO grade IV malignant glioma     patients may have an effect on subsequent deterioration of neurocognition and     patient-reported outcomes.   "
125710|NCT01639599|"     Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and     vomiting (PONV). However, precise dose-response studies have not been completed, especially     in patients at high risk for PONV who require combination therapy. This study sought to     identify the optimal dose of haloperidol that could be combined with dexamethasone without     adverse effects in high-risk PONV patients receiving intravenous patient-controlled     anesthesia (IV PCA) after gynecological laparoscopic surgery.   "
125711|NCT01639586|"     One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to     helping families. It's also of major to involve the patient in the most active treatment     possible, encouraging social inter relationship as well as cognitive and behavioural     stimulation activities.      In the frame of non drug related approaches to Alzheimer disease (AD), several research     projects and actions have already been conducted, but no specific study concerning the     efficiency of different types of respite care structures have been conducted so far in     France. The present project concerns the thematic of the frame Development and     diversification of respite care structures.      A platform is defined in the Alzheimer Plan as a diversified range of despite structures     according to patients' needs and informal caregivers' expectations providing several     objectives:      Two objectives targeting the informal caregivers:        -  offer spare time or tutored        -  inform, support and accompany      Two objectives targeting the patients:        -  encourage maintain of the patient social life and relationships and work together          towards his/her psychological and emotional well-being        -  contribute to improve functional cognitive and sensory capacities      The study COMPARSE suggests to compare for the patient - informal caregiver couple, the     impact of three different groups of patient care on health profit; resit platform (P), the     day care group (D), the control group without access to a respite structure (C).   "
125712|NCT01639573|"     This phase I/II pilot trial seeks to demonstrate that prolonged administration of Campath-1H     without prior marrow or stem cell harvesting can result in immunoablation similar to that     achieved by hematopoietic stem cell transplantation (HSCT) from either bone marrow or     peripheral blood stem cell sources in children and adolescents with severe treatment     refractory systemic sclerosis (SSc).   "
125713|NCT01639560|"     The purpose of this study is to determine if varenicline is effective in treating tobacco     dependence in adults who smoke 5-10 cigarettes per day.   "
125714|NCT01639547|"     The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD)     plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the     clearance of HCV viremia 24 weeks after treatment end   "
125762|NCT01638923|"     To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and     dienogest in the treatment of heavy menstrual bleeding   "
125716|NCT01639521|"     This study is about two chemotherapy study drug combinations (regimens) that are used for     urothelial (bladder or upper urinary tract) cancer. Both study drug regimens, gemcitabine     (gemcitabine hydrochloride) plus cisplatin, and high-dose-intensity MVAC (methotrexate,     vinblastine, doxorubicin plus cisplatin), are standard chemotherapy regimens. Both regimens     are used to treat people with urothelial cancer that has spread to other organs. Both study     drug regimens have been proven to be effective in lowering the risk of the cancer coming     back, but it is not known which regimen is the best. This study hopes to learn whether there     is a difference in the effectiveness and side effects of these two study drug regimens when     they are given to people who have had their urothelial cancer completely removed.   "
125767|NCT01638858|"     In this prospective, open-label clinical study is to investigate the behavior of the retinal     functions during development of diabetic macular disease (DME) under the influence of     Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used     here as an objective criteria to information about the retinal function obtain.   "
125717|NCT01639508|"     The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good     and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK     fusion, or increased MET or AXL activity.      A phase II study looks at how effective a medication is at treating a specific type of cancer     and collects information on the side effects of the study treatment.      RET, ROS1, or NTRK fusion or increased MET or AXL activity gene leads to lung cancer cell     growth. Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In     addition, this drug interferes with other cell pathways that also cause cancer cells to grow,     form new blood vessels, and spread to other organs of the body. The goal of using     cabozantinib is to shrink the cancer and to prevent it from growing      Cabozantinib has been studied and shown to cause cancer shrinkage in other cancers such as     medullary thyroid cancer and prostate cancer. We thus have a good idea of what side-effects     it causes and can anticipate them.   "
125718|NCT01639495|"     This is a prospective, multicenter, non-randomized continued access clinical evaluation     utilizing the THERMOCOOL® SMARTTOUCH™ catheter.   "
125719|NCT01639482|"     Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using     18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).     The following hypothesis will be tested: Antidepressant response or remission in depressed     BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and     paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and     anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed     patients.   "
125720|NCT01639469|"     This project is investigating whether a one-year in-home exercise program will reduce the     rate of falls and improve strength and quality of life in patients with Parkinson's disease.   "
125721|NCT01639456|"     This is a phase II trial designed to test the safety and efficacy (disease free survival     [DFS]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute     myelogenous leukemia (AML). The natural killer (NK) cell product will be given to patients 60     years and older who are in a first complete remission after 1 or 2 courses of standard AML     induction. After a preparative regimen of cyclophosphamide and fludarabine, patients will     receive a single infusion of either CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a     short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.   "
125722|NCT01639443|"     In this research study, investigators use colonoscopy as a case example to evaluate a     predictive overbooking model derived using patient-level predictors of absenteeism. The     no-show overbooking intervention employs a logistic regression model that uses patient data     to predict the odds of no-showing with 80% accuracy. These projected no-show appointments     will be overbooked by clerks for patients who agree to join a fast track short-call line.     By rapidly processing endoscopy patients and moving them out of traditional slots,     investigators predict more scheduling slots would become available for patients awaiting     colonoscopy.   "
125723|NCT01639430|"     Retrospective analysis of a quality measurement project examining the quality of vital     parameter measurement in consecutive patients >= 75 years presenting to the emergency     department.      Primary goal of the study is to evaluate the diagnostic accuracy of body temperature     measurement using different methods to diagnose infection in patients >= 75 years presenting     to the emergency department. The secondary goal is to compare the reliability of tympanal and     temporal artery thermometry with rectal temperature measurement.   "
125724|NCT01639417|"     The purpose of this study is to better understand why some women with breast cancer develop     chronic pain.   "
125725|NCT01639404|"     This study aims to evaluate the efficacy of umbilical cord blood therapy for children with     cerebral palsy.   "
125726|NCT01639391|"     Patients with ALS will be included in the reference center for ALS in hospital La Pitié     Salpêtrière, Paris.      The study proposes to investigate the pathophysiology of ALS by setting up a fibroblast bank     for studying molecular, cellular and genetic parameters of the pathology.      iPS (induced pluripotent stem cells) and then differentiated cells will be generated.      The pathophysiology of ALS will be studied on the 3 types of cells (fibroblasts, iPS,     differentiated cells).   "
125727|NCT01639378|"     The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety     and effectiveness of renal denervation in subjects with chronic systolic heart failure.     Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system     that delivers radio frequency (RF) energy through the luminal surface of the renal artery.   "
125728|NCT01639365|"     The pressure exerted by the ablation catheter on the tissue has been shown to play an     important role on determining the size and the potential efficacy of the ablation lesions. A     direct information on the force exerted by the catheter tip obtained from the SmartTouch     technology might improve the assessment of the scar areas during electroanatomical mapping in     patients with ventricular tachycardia (VT) due to ischemic disease or cardiomyopathy. The     objectives of the study are to compare the areas of scar (defined as a low-voltage threshold)     obtained from the conventional voltage map with those obtained after the contact map     information is available to the operator and to determine if the availability of the contact     information allows an improvement of the electroanatomic map by correcting the points taken     in no-contact areas. Twenty to 30 consecutive patients with ventricular arrhythmias due to     ischemic heart disease or dilated cardiomyopathy undergoing VT ablation will be included in a     prospective, one-center, non-randomized study. A voltage map of the left ventricle will be     obtained using the CARTO-3 navigation system and the scar areas as well as the areas of     potential interest for ablation will be delineated in the standard way and saved as the     control map. The force information will be recorded by the system but will not be available     to the operator until the control map is saved. Following this step the contact map will be     available to the operator to be compared with the control map and further mapping and point     acquisition will be allowed to correct the areas previously acquired with poor or no contact.     The final map after corrections have been made will be saved as the corrected map. The     ablation procedure will then be performed as usual. Both maps will be compared in a deferred     way to know how are classified the areas without contact when no pressure information is     available, and how many non-contact points are falsely assumed to be low-voltage or dense     scar points. These comparisons will give information on how much the standard electroanatomic     map can be improved when the force information is added.   "
125729|NCT01639352|"     The hypothesis of this clinical trial is that hepatocellular carcinomas contain somatostatin     receptors which make them sensitive to the inhibitory effects of a new somatostatin analog,     SOM230. This analog has greater and broader binding affinity to somatostatin receptors     compared to the current drug in use, sandostatin LAR. Thus, SOM230 has the potential to be     more effective in the treatment of patients with hepatocellular carcinoma.   "
125730|NCT01639339|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab     in adult patients with active lupus nephritis.   "
127476|NCT01616511|"     The objective of the study is to demonstrate the long-term safety and performance of the ATI     Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in     cluster headache subjects.   "
125731|NCT01639326|"     This study aims to use the corresponding pharmacogenetic analysis to increase the dose of     irinotecan in the schemes commonly used standard chemotherapy in advanced colorectal cancer     treatment first. The project aims to improve the therapeutic index of chemotherapy. This     optimization is raised based on the administration of different doses of the drug depending     on the genotype UGT1A1 gene. The research team proposes this project to demonstrate how the     administration of high doses of irinotecan in the FOLFIRI scheme in patients with genotype     UGT1A1 favorable (wild homozygous * 1 / * 1 and heterozygous * 1 / * 28), significantly     improves the efficiency of the antineoplastic agent without significant increase in toxicity.     Secondarily will assess the possible prognostic factors related to tolerance and efficacy.      The primary objective is to evaluate the efficacy of high doses of irinotecan in the FOLFIRI     scheme in patients with metastatic colorectal cancer with a favorable genotype UGT1A1 (wild     homozygous * 1 / * 1 and heterozygous * 1 / * 28).   "
125732|NCT01639313|"     A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its     determination has been difficult using the standard approaches. The aim of the study is to     evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac     magnetic resonance imaging (CMR).   "
125733|NCT01639300|"     The purpose of this study is to assess the safety and tolerability of single ascending doses,     as well as of repeated administrations of GNbAC1 in MS patients.      Scientific research has shown that the expression of genes of a virus which is integrated in     the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a     critical role in the causation of multiple sclerosis.      GNbAC1 is an experimental medication, which neutralizes (i.e. inactivates) a protein of MSRV     that might contribute to the development or deterioration of multiple sclerosis.   "
125734|NCT01639287|"     There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically     painless synovitis in the hands.      The objective of this study is to compare painless synovitis with painful synovitis according     to the sonographic (Gray-scale and power Doppler) findings.      A sonographic examination (Gray-scale and power Doppler) will be done to evaluate     metacarpophalangeal joints of patients without local painful and will be a comparison with     patients with local painful.   "
125735|NCT01639274|"     Highly active antiretroviral therapy (HAART) has considerably improved survival of     HIV-infected patients. Opportunist diseases and cancers linked to immunodepression have     largely regressed. Challenge is now the management of cardio-vascular diseases, nephrologic,     neurologic, osteo-articular diseases, chronic hepatitis and cancer no linked to     immunodepression. All this comorbidities are more reported in HIV-infected patients than in     general non-HIV infected patients. Those are directly linked to the effect of chronic     HIV-infection on ageing, metabolic effects of HAART, and way of life characterising this     population.      Chronic obstructive pulmonary disease (COPD) results from tobacco consumption. Bronchial     chronic infection, immunity, and ageing are also involved in the physiopathology of COPD.     This disease has never been evaluated in a large prospective cohort of HIV-infected patients     whereas there is a known increase of tobacco consumption and pulmonary infection in this     population regardless to the general population.      Characterisation of COPD disease in HIV patients will allow us to make an hypothetic     epidemiological link between HIV- HAART and COPD independently of tobacco consumption, and to     study different physiopathologic hypothesis evocated in COPD genesis, like an accelerate     pulmonary ageing.   "
125736|NCT01639261|"     Improvement of quality of life in patients with BO and establishment of a new third line     therapy   "
125737|NCT01639248|"     The purpose of this study is to determine the activity of ENMD-2076 as defined by the     clinical benefit rate when patients with previously treated locally advanced or metastatic     triple negative breast cancer are treated with daily oral ENMD-2076.   "
125738|NCT01639235|"     This is a study on a population of flight attendants who were exposed to occupational     secondhand tobacco smoke (SHS). This research will examine associations between flight     attendant SHS exposure and development of respiratory illnesses, reproductive problems, and     cardiovascular diseases.   "
125739|NCT01639222|"     The purpose of this study is to demonstrate that the intestinal absorption of calcium from a     newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount     of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to     baseline.   "
125740|NCT01639209|"     The purpose of this research study is to compare the outcomes of pneumatic retinopexy with     the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal     detachment, in terms of anatomical success, functional success and impact on patient quality     of life.   "
125741|NCT01639196|"     The purpose of this study is to explore the effects of writing about chronic pain on mental     and physical health. The effectiveness of two different types of brief online writing     interventions will be explored in individuals with chronic pain.   "
125742|NCT01639183|"     The purpose of this study is to investigate whether brushing the teeth of nursing home     residents with a power toothbrush as compared with standard care typically provided in     nursing homes, will increase caregiver compliance with the provision of daily oral care as     well as lower oral and systemic inflammation.   "
125743|NCT01639170|"     The aim of this study is to evaluate if the presence of abdominal free air on a plain chest     radiograph predicts gastrointestinal perforation. We aimed to enroll all patients undergoing     abdominal surgery reporting major symptoms and signs suggestive of gastrointestinal     perforation (abdominal pain, leukocytosis, fever) within the third postoperative day.   "
125763|NCT01638910|"     To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate     and dienogest in healthy female subjects.   "
125744|NCT01639157|"     Cocaine use disorders are an unrelenting public health concern. Intensive research efforts     have yielded behavioral interventions that reduce cocaine use, however, these interventions     are not universally effective and treatment effects diminish over time. Development of a     pharmacotherapy that enhances the efficacy of these interventions is a priority for the     National Institute on Drug Abuse. This study proposes to determine the impact of buspirone     maintenance on self-administration of cocaine and alternative reinforcers. These preliminary     data will be used to support further research developing buspirone as a pharmacotherapy for     cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects     of cocaine and increase the reinforcing effects of alternative reinforcers.   "
125747|NCT01639118|"     Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with     abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh     technology have been developed for the specific indication of small ventral hernias; this     technique is very attractive because the mesh can be introduced through a nearly invisible     scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the     viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No     literature is available on the adequate size of mesh needed to repair a hernia defect of an     umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a     large mesh device. Small hernias might benefit of repair with a small mesh device so no     enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size     to have more overlap of the mesh beyond the hernia defect.      With this prospective cohort study the investigators want to explore the efficacy of C-QUR     V-Patch of different sizes for the different sizes of hernia defects.   "
125748|NCT01639105|"     Rationale The cosmetic aspect of scars is a frequent reason for consultation. It plays an     important role in patient satisfaction and self-image. Several treatment modalities are     proposed for scars with variable success.      Ablative fractional laser treatment is a rather new concept. Many microscopic small laser     beams target the dermis in a grid pattern. The vertical columns of skin hit by the laser     beams heat up. This thermal effect stimulates the wound healing and potentially leads to a     remodeling of the skin structure.      Ablative fractional laser treatment has been used successfully for treatment of pigment     changes, wrinkles, acne scars and thermal burn wounds. It has been reported that CO2 ablative     fractional laser treatment has a positive clinical effect on various types of scars however     this has not been proven yet in a prospective randomized trial. The low morbidity of the     treatment and the lack of convincing adapted treatment modalities for various types of scars     make this treatment attractive.      That's why the investigators aim with this randomized study to evaluate the clinical effect     and the safety of 10 600 nm ablative fractional laser therapy for patients with recent scars     due to surgical interventions.      Goal Evaluate the efficacy of three 10 600 nm ablative fractional laser treatments for the     above mentioned scars, three months after the last laser treatment, with a prospective     randomized intra-patient controlled study.      Study design Prospective single blinded randomized intra-patient controlled study. The study     comprises 4 study visits.      Study population The population consists of one group of patients with scars after recent     surgical operations. The patients must meet the inclusion and exclusion criteria described in     the protocol.      Method The scar will be divided in two equal halves. The two halves will be randomized. One     part will not be treated. The other part will undergo three times the 10 600 nm ablative     laser therapy with 4 weeks interval between the treatments. The efficacy of the treatment     will be evaluated three months after the last treatment with objective and subjective     parameters.      Most important study endpoints:        -  Evaluation of the efficacy of the treatment. A blinded clinical scar evaluation will be          done of the treated and untreated parts with the POSAS scar scale, by a study          collaborator and by the patient himself, on a category scale of 0 to 10 (0 = normal          skin, 10 = worst scar imaginable), before start and twelve weeks after the last          treatment.        -  Evaluation of the pain related to the treatment. The pain will be scored by the patient          with the VAS category scale from 0 to 10 (0 = no pain, 10 = worst pain ever).        -  Evaluation of the side effects of the treatment. A standardized form will be used.        -  Evaluation of the global patient satisfaction regarding the treatment.        -  Clinical photos, before start and twelve weeks after the last treatment.   "
125749|NCT01639092|"     With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil     fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by     polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve patients.     Until recently, however, many patients commenced antiviral treatment with inferior NAs prior     to the availability of TDF or ETV, such as lamivudine (LAM) which has a low genetic barrier     to resistance.      ETV resistance increase up to 51% of patients after 5 years of ETV treatment in     lamivudine-refractory patients. Resistance to ETV appears to occur through a two-hit     mechanism with initial selection of M204V/I mutation followed by amino acid substitutions at     rtT184, rtS202, or rtM250.      In vitro studies showed that ETV-resistant mutations are susceptible to TDF, but there are     little clinical data on the efficacy of TDF monotherapy in patients with ETV-resistance.      On the other hand, there was a retrospective cohort study reporting that, with the     combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6     months of treatment. Probability of reaching complete HBV DNA suppression was not decreased     in patients with ADV or ETV-resistance.      Thus, there is no consistent treatment recommendation for patients with ETV-resistance.      In this clinical trial, the investigators will clarify whether tenofovir monotherapy is as     effective as tenofovir plus entecavir in inducing complete virologic response in CHB patients     with genotypic resistance to ETV and partial virologic response to ongoing treatment.   "
125750|NCT01639079|"     The primary goal of this project is to carry out a randomized controlled trial (RCT)     comparing quit rates of a Spanish/English stop smoking Web site to those of a no-intervention     or quit on your own control. The investigators have not included a no-intervention     condition in previous Web studies and although 20% of participants quit smoking at one year     are 20%, obtaining evidence that the investigators interventions yield higher abstinence     rates than a no-intervention control is the next logical step. Furthermore, although the     investigators Web site was designed in English and Spanish, the investigators success in     attracting the U.S. Hispanic/Latino (HL) population in either language has been limited, so     this project only will only conduct intensive telephone follow-up of HL smokers and add new     recruitment methods to do so.   "
125764|NCT01638897|"     The purpose of this study is to evaluate long-term performance of the DF4 Connector System.     This evaluation is based on the number of DF4 lead-related complications occurring during the     study compared to the number of leads enrolled in the study. The DF4 systems will be followed     for 5 years after implant. This study is required by FDA as a condition of approval of the     DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance     platform.   "
125765|NCT01638884|"     The purpose of this study is to investigate prospective merory (memory of intentions) in     healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease)     patients.   "
125777|NCT01638728|"     The investigators compared the depth of the RAE tube [Preformed oral tracheal tubes were     first described by Ring, Adair and Elwyn (therefore called RAE tubes)] when fixed at the     midline and at the angle of the mouth, and after fixing the tube at the angle.   "
125778|NCT01638715|"     The purpose of this study is to find biological response patterns of patients with rheumatoid     arthritis to drugs with different biologic modes of action. This study should help to predict     therapeutic responses and to find the right therapy for the right patient.   "
125779|NCT01638702|"     Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the     arms, but which pass in the veins to beside the heart. They are associated with occasional     complications due to infection or blockage of the vein that they are in. The investigators     want to investigate whether PICCs in the right arm have lower complications than those in the     left. This difference in complication rates has been noticed in most other forms of central     venous access.   "
127406|NCT01617434|"     This trial is conducted in Asia, Europe and North and South America. The aim of the trial is     to investigate the effect of liraglutide versus placebo when added to basal insulin analogues     with or without metformin in subjects with type 2 diabetes.   "
125751|NCT01639066|"     With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil     fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by     polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve patients.     Until recently, however, many patients commenced antiviral treatment with inferior NAs prior     to the availability of TDF or ETV, such as lamivudine (LAM) or adefovir (ADV) which has a low     genetic barrier to resistance.      For patients who developed genotypic resistance against ADV, the efficacy of TDF monotherapy     is controversial. In recent studies, TDF monotherapy produced significant suppression of HBV     replication. However, only half of patients with initial ADV resistance achieved an     undetectable viral load (<15 IU/ml) with 48 weeks of therapy.      On the other hand, there was a retrospective cohort study reporting that, with the     combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6     months of treatment. Probability of reaching complete HBV DNA suppression was not decreased     in patients with ADV or ETV resistance.      Together, these observations indicate that there is a controversy about the efficacy of TDF     monotherapy in patients with genotypic resistance to ADV.      Thus, in this clinical trial, the investigators will clarify whether tenofovir monotherapy is     effective in inducing complete virologic response compared with tenofovir plus entecavir in     CHB patients with genotypic resistance to ADV and partial virologic response to ongoing     treatment.   "
125752|NCT01639053|"     This is a ten-year postapproval study to evaluate the long-term clinical performance of     Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket     environment.   "
125753|NCT01639040|"     The purpose of this study is to assess the safety of REGN668 (SAR231893) administered     concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic     dermatitis (AD).   "
125754|NCT01639027|"     Reducing the length of labor is a highly desirable goal of intrapartum care, both from a     perspective of maternal and fetal well-being, and for the providers of the birth services.     Avoiding along, protracted labor entails shorter exposure to pain, anxiety and stress and     would thus translate into a major improvement in maternal satisfaction with the childbirth     experience.      Based on the premise that shortening the length of labor is beneficial, interventions aimed     at accelerating the progression of labor have been introduced routinely as part of standard     labor management and care throughout the 20th century. Certain labor accelerative procedures,     such as amniotomy, became common practice and have been put to the acid test of randomized     control trials to evaluate their efficacy. Use of anticholinergics/antispasmodics as a method     of augmenting labor was ﬁrst described in 1937 by Hirsch, who reported a decrease in labor     length by two to four hours following Intrapartum administration of an atropine-like drug     (Syntropan®)mainly among older nulliparas.      Drotaverine, an isoquinolone derivative is a superior smooth muscle relaxant which acts     specifically on spastic sites and corrects the cAMP and calcium balance relieving smooth     muscle spasm.      This inhibitory action is detected only in lower uterine segment during labor since muscle     fibers in upper uterine segment are strongly affected by contractile effect of oxytocin. Use     of drotaverine during pregnancy is free of any teratogenic and embryotoxic effects.      The Research question is: Does the use of antispasmodic Drotaverine shorten the duration of     active first stage of labor in nulliparous women as compared to placebo?   "
125755|NCT01639014|"     The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake     inhibitor (SNRI) nin functional recovery after ischemic stroke.   "
125756|NCT01639001|"     This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single     agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in     First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer     Patients. The objective of the study is to demonstrate that Crizotinib is superior to     first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging     Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose     tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma     Kinase) gene locus.   "
125757|NCT01638988|"     The results of studies conducted until now does not determine what the best way to treat     infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study     objective is to determine the best treatment for such patients. The long-term consequence     health of women with PCOS are multiple. The woman with PCOS has a risk of developing     metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin     resistance plays an important role in all this medical condition. Clomiphene Citrate (CC)     remains the first line treatment to induce ovulation in women with PCOS and anovulatory     infertility.   "
125758|NCT01638975|"     This study tests a computerized cognitive training program designed for young individuals     with compulsive hair pulling (also known as trichotillomania;TTM). Research suggests that     individuals with TTM are characterized by poor cognitive abilities to suppress irrelevant     response. This ability is called response inhibition. The current study tests a cognitive     training program designed to improve individuals' cognitive abilities of response inhibition     through a 8-session computerized training program. The investigators hypothesize that those     who complete the response inhibition training program will show a greater reduction in hair     pulling symptoms, compared to those assigned to a waitlist group.   "
125759|NCT01638962|"     The purpose of this study is to compare the effects of neuromuscular exercise and analgesic     use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA).      It is expected that the two groups will receive equipotent pain relieving effect, despite     this, the investigators expect a between group difference in knee joint load, and the     exercise group will have a reduction in knee joint load.   "
125760|NCT01638949|"     Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight.     An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough     from a social, financial and research standpoints. Therefore, the investigators need     predictive markers of AD, and neuroimaging is a particularly promising tool, especially when     using complementary neuroimaging techniques and a longitudinal design, allowing to assess the     relationships between the different biomarkers of the disease, their dynamic and their     chronology.   "
127520|NCT01615939|"     The purpose of this study is to compare the incidence of postoperative symptoms of neurologic     injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous     infragluteal-parabiceps sciatic nerve catheter.   "
125768|NCT01638845|"     INTRODUCTION: Hip Fracture is a public health problem because of its constantly increasing     frequency and its high morbidity and mortality. The leading cause of death is cardiovascular     decompensation, caused by painful phenomena associated with fracture and orthopedic     surgery.With hip fracture, epidural local analgesia techniques have proven their benefit in     mortality but are associated with numerous side effects that prevent routine use. Peripheral     analgesic techniques locoregional the lumbar plexus, much safer, cause a decrease in     postoperative pain after surgery for hip fracture and a decrease in mortality at 6 months.     Elderly patients suffering from a hip fracture, no study has investigated the effect of local     analgesia continuous femoral perineural catheter on the incidence of cardiovascular events in     the perioperative period.      OBJECTIVE: The main objective of this work is to show that perineural analgesia block     continuous local anesthetic reduces the incidence of cardiovascular complications in the     preoperative period of a patient with a hip fracture and fact, show that this technique     decreases the incidence of mortality at one year of patients with a hip fracture (secondary     objective).      MATERIAL AND METHODS: This is a prospective, multicenter, randomized, descriptive type. It     compares two populations of patients: one has a perineural analgesia by continuous infusion     via a catheter of ropivacaine (n = 157) associated with a systemic analgesia and the other     only systemic analgesia without development of a catheter perineural (n = 157). The duration     of patient participation will be 12 months. In the first 24 hours after a hip fracture after     randomization, study participants will benefit from the installation under strict asepsis, a     continuous block by catheter, placed by an anesthesiologist experienced control room     post-interventional. The local analgesia will be provided by continuous administration via     the perineural catheter, ropivacaine for 5 days for the treated group. Except the local     analgesia protocol, the protocols pre-and postoperative systemic analgesia and general     anesthesia will be identical for all participants of the 2 groups, similar to techniques     proposed in the context of everyday clinical practice, ensuring analgesia optimal for all     patients in the study. The main features will be found three bioassays Troponin IC and 3     electrocardiograms at the entrance to the hospital, J3 and J5 after inclusion. In addition,     cardiovascular clinical monitoring and quantification of pain ( will be performed daily for 8     days after inclusion. Finally, an assessment of higher functions by ladder MMS will be     conducted at the entrance, J3, J5 and J8. Moreover, a survey of survival at 1 month, 3 months     and 1 year will be realized.   "
125769|NCT01638832|"     This study will evaluate the association of non-alcoholic fatty liver disease and coronary     artery disease. All patients presenting for coronary angiogram will receive the following     examination:        -  Transient Elastography and Controlled Attenuation Parameter using the FibroScan        -  blood examination including biochemical markers The results of non-invasive liver          steatosis and fibrosis measurement are compared with the results of coronary angiogram          concerning the presence or absence of coronary artery disease.   "
125770|NCT01638819|"     Evaluate the efficacy of one infusion of stem cells from autologous umbilical cord blood in     patients with autism over six months after infusion as measured by changes in expressive and     receptive language.      Also demonstrate improved behavior, learning, and changes in Serum tumor necrosis factor     alpha (TNF-α), tumor necrosis factor beta (TNF-β), interleukin 1-alpha (IL-1α), interleukin     1-beta (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 13 (IL-13).   "
125771|NCT01638806|"     Patients with acute myocardial infarction (AMI) are categorized according to the     electrocardiogram (ECG) findings into: 1) patients with ST-Elevation Myocardial Infarction     (STEMI), 2) patients with Bundle Branch Block Myocardial Infarction (BBBMI), and 3) remaining     patients with so-called NON-ST-Elevation Myocardial Infarction (NONSTEMI).      Patients with STEMI or BBBMI are treated with acute angioplasty (PPCI=primary percutaneous     coronary intervention), and the sooner PPCI is performed the lower is the mortality. This is     why prehospital diagnosis and field-triage of patients with STEMI directly to heart centers     with PPCI facilities is recommended.      In patients with NONSTEMI previous trials have indicated that early angioplasty, within 72     hours of symptom onset, is associated with improved outcome when compared to late angioplasty     or conservative therapy. No trials have so far been able to diagnose patients with NONSTEMI     in the prehospital phase or immediately on arrival at a hospital, and triage them directly to     PPCI. Implementation of point-of-care (POC) testing of biomarkers may enable prehospital or     early inhospital establishment of the diagnosis NONSTEMI.      The aim of the present trial is to identify patients with NONSTEMI in the prehospital phase     or immediately on arrival at the local hospital based on a) symptoms, b) POC testing and c)     ECG findings and then randomize patients to I) PPCI, or II) medical therapy and     angiography/angioplasty within 72 hours (todays routine).      Se below for detailed description   "
125772|NCT01638793|"     The present study is a randomized, prospective, single-blinded study. Patients presenting for     colonoscopy under sedation will be included according to the statistical sample size     calculation. Patients will be randomized to either group 1- capnographic monitoring or group     2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia     are documented and compared in both groups.   "
125773|NCT01638780|"     The main objective of the study is to investigate if resveratrol supplementation can improve     overall and muscle-specific insulin sensitivity in type 2 diabetic patients.      As a secondary objective the investigators want to investigate whether the improved insulin     sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a     reduced intrahepatic and cardiac lipid content.   "
125774|NCT01638767|"     Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take     Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in     order to better control and also plan the onset of the ovary stimulation with gonadotropin.      Marvelon is taken daily as soon as menstruation starts for a period of 14 to 21 days.     Ideally, it has to be taken at the same time everyday and not be forgotten. This may cause     higher stress level for some users. Presently on the market, there is a ring-shaped     contraceptive device inserted in the vagina at day 1 of the cycle called NuvaRing. The     purpose of this device is similar to an oral contraceptive. However, the benefit of NuvaRing     is that it can be left in place for a period of up to 35 days without any other manipulation     and keep an adequate rate of hormone for contraception. Moreover, NuvaRing shows better     hormone stability in the blood. Although the side effects and the benefits are comparable for     the two treatments, some studies have shown that more patients would respect the treatment     with NuvaRing and that the level of satisfaction would be higher in women using NuvaRing when     contraception is needed.      The purpose of the study is to compare the rate of satisfaction as well as the level of     stress in women using Marvelon daily or NuvaRing with single insertion in a long protocol.     Moreover, this study allow us to verify if using NuvaRing, a vaginal contraceptive releasing     constant daily doses for up to 35 days will allow us to facilitate the planning of In Vitro     Fertilization cycles in long protocol.   "
125776|NCT01638741|"     The purpose of this study is to provide new knowledge about:        -  Integration of rehabilitation in a highly specialized gynaecological department.        -  Development and testing of an individually adapted rehabilitation process.        -  Needs for rehabilitation among women with gynaecological cancer.        -  Connection between adult attachment style for women with gynaecological cancer and their          quality of life, rehabilitation needs and symptoms of depression /PTSD.   "
125781|NCT01638676|"     The main purpose of this study is to evaluate the safety of Vemurafenib in combination with     Metformin in melanoma patients. The phase II part of the study will also evaluate the     clinical activity of the combined regiment. Based on pre-clinical studies and a phase I     trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose     of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes     in terms of objective response rates and survival in metastatic melanoma patients.   "
125782|NCT01638663|"     The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium     and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure,     pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide     synthesis in healthy subjects.   "
125783|NCT01638650|"     This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a     modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients.     Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first     week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second     week. The study treatment will be given in combination with two Nucleoside Reverse     Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment     guidelines. Anticipated time on study treatment is 14 days.   "
125784|NCT01638637|"     The objective of this study is to obtain female first-catch urine, vaginal, cervical and     endocervical swabs and male first-catch urine and urethral swabs for testing with multiple     APTIMA Assays on the Gen-Probe PANTHER® System   "
125785|NCT01638624|"     The release of tourniquet produces reactive oxygen species which can cause injury. Propofol     is chemically similar to phenol-based free radical scavengers.      Plasma total antioxidant capacity is a well-established marker of the overall protective     effect of antioxidants in body fluids.The aim of the study is to investigate the effects of     propofol on ischemia-reperfusion injury in total knee arthroplasty (TKA).   "
125786|NCT01638611|"     HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is     the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown     signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes,     repeat dose treatment with HIP results in new islet formation and improvement in blood     glucose measurements.      HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.      The present clinical trial protocol proposes the first administration of HIP2B to humans with     the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous single     ascending doses.   "
125787|NCT01638598|"     Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after     single rising doses (SRD) in healthy Asian male volunteers   "
125788|NCT01638585|"     In this randomized clinical trial (RCT) the investigators are trying to find out whether a     low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum     of 30 days is capable of prolonging the survival time without major amputation.   "
125789|NCT01638572|"     Well-regulated glycosylation is essential for the normal development of the nervous system.     Altered expression of glycosyltransferases with resulting dysregulated glycosylation of     neuroblastic cells might lead to the development of NB. The     β1,4-N-acetylgalactosaminyltransferase III (B4GALNT3) exhibits GalNAc transferase activity to     form the GalNAcβ1,4GlcNAc (LacdiNAc or LDN) structure. The Drosophila B4GALNTA, homolog of     human B4GALNT3, has been suggested to regulate the neuronal development. By     immunohistochemical studies, we demonstrated that the expression of B4GALNT3 correlated well     with histological grade of differentiation in NB tumor samples. Since well differentiated     tumors usually carry a better prognosis, we thus speculate that expression of B4GALNT3 in     tumor tissues can a favorable prognostic factor of NB.      To explore the role of B4GALNT3 in the prognosis of NB, we propose the following project with     two specific aims:      Aim Ⅰ: Establishing the significance of B4GALNT3 in the prognosis of NB: We plan to collect     90 NB tumor samples, and evaluate the RNA and protein expression levels by Q-PCR, Western     blot, and immunohistochemistry in the tumor samples. The results will be compared with the     other clinicopathological and biological factors of NB. Also the expression levels of     B4GALNT3 in tumor tissues will be correlated to the patients' outcome to clarify whether     B4GALNT3 could be a prognosis marker of NB.      Aim II: Clarifying the effects of B4GALNT3 on NB cell behavior in vitro and in vivo. For     further strengthening the prognostic role of B4GALNT3 in NB, NB cell phenotype and behavior     changes after overexpression or knock-down of B4GALNT3 are evaluated by in vitro assays as     well as by a nude mice xenograft model.      In summary, if our project can establish the role of B4GALNT3 expression in NB, we may     further subclassify the NB patients, and give the NB patients more appropriate therapies to     improve patients' outcome. Furthermore, B4GALNT3 could potentially serves as a therapeutic     target in the future.   "
125790|NCT01638559|"     The primary objective of this study is to assess the efficacy of immunosuppression withdrawal     (ISW) in pediatric liver transplant (tx) recipients.   "
125804|NCT01638377|"     This pilot study will explore the ways to link Ontario's remedial system for convicted     drinking drivers to medical intervention, assess the receptiveness of the Back on Track     client population to effective medical interventions, and assess the feasibility of a     full-scale trial of pharmacotherapy for convicted drinking drivers.   "
125791|NCT01638546|"     This randomized phase II trial studies how well temozolomide with or without veliparib works     in treating patients with small cell lung cancer that has returned or does not respond to     treatment. Temozolomide works by damaging molecules inside the cancer cells, such as     deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may     stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged     DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether     temozolomide is more effective with or without veliparib in treating patients with relapsed     or refractory small cell lung cancer.   "
125792|NCT01638533|"     This phase I trial studies the side effects and best dose of romidepsin in treating patients     with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction.     Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking     the activity of proteins that are important for the cancer's growth and survival.   "
125808|NCT01638325|"     BC106 is a molecule that when injected with insulin lispro may change the speed of absorption     of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin     lispro and any side effects that might be associated with it, blood levels of insulin lispro     after injection under the skin and how BC106 insulin lispro affects blood sugar after     injection under the skin. There is a minimum 7 day washout between single doses.   "
125908|NCT01637025|"     The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help     stop bleeding in participants undergoing open cardiac, intra-abdominal (including     retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some     countries marketed as Tabotamp®)   "
125793|NCT01638520|"     New approaches are needed to achieve more rapid elimination of dormant mycobacteria and     thereby shorten treatment for drug-sensitive and drug-resistant tuberculosis (TB). Dormant     mycobacteria are relatively resistant to antibacterial drugs and approaches that enhance     immune clearance have the potential to be more effective. Interleukin-4 (IL-4) is a key     cytokine in the immune response to TB that may impair the clearance of mycobacteria. We     hypothesize that pascolizumab, an anti-IL-4 monoclonal antibody, might be of value as an     adjunct to standard treatment.      The aims of this trial are to determine whether administration of pascolizumab as an adjunct     to standard combination treatment for drug-sensitive TB produces changes in one or more     parameters of bacterial or host response (including bacterial clearance, host clinical     status, immune response, bacterial and host transcriptomics, lung imaging) that may indicate     potential for enhanced sterilization and to confirm the safety of blocking IL-4 (previously     demonstrated in healthy volunteers and patients with asthma) in patients with TB.   "
125794|NCT01638507|"     The purpose of this post approval study is to conduct a prospective, multicenter evaluation     of the procedural and clinical outcomes of subjects that are treated with the commercially     available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.   "
125795|NCT01638494|"     Calcium (Ca2+) and vitamin D (VitD) play an important role in child health. Aims. The     investigators evaluated the daily intake of Ca2+ and VitD in healthy children; and the     efficacy of Ca2+ and VitD supplementation. Daily Ca2 + and VitD intake was evaluated in     consecutive healthy children through a validated questionnaire. Subjects with a daily Ca2 +     and VitD intake < 70% of dietary reference intakes (DRIs) were invited to participate in     prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary     counseling aiming to optimize daily Ca2+ and VitD intake plus administration of a     commercially available Ca2 + and VitD supplementation product (Colecalcium®, Humana, Milan,     Italy); group 2, dietary counseling alone. At the enrollment (T0) and after 4 months (T1)     serum VitD levels were assessed.   "
125796|NCT01638481|"     The purpose of the study is to identify the inflammatory and coagulation pathways and     mechanisms that are activated immediately following burn injury, and how they affect outcomes     in terms of organ failure and death. This study also addresses the limitation of current     tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in     severely injured patients both in a comprehensive and rapid manner.   "
125797|NCT01638468|"     The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety,     efficacy, adverse events and any new information that may surface regarding the use of the     AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main     pulmonary and lobar arteries ≥ 6mm in diameter.   "
125798|NCT01638455|"     Characterize Masimo noninvasive technology in spot check reading on subjects and make     comparison to invasive blood sampling tested on reference analyzers.   "
125799|NCT01638442|"     The objectives of this study are to evaluate the safety and tolerability; and to determine     the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.   "
125800|NCT01638429|"     The purpose of this study is to determine how certain types of bacteria in the human gut may     affect weight gain, and contribute to the development of diabetes.      The investigators initial studies have shown that gut bacteria that produce methane may     directly affect weight gain. These bacteria, called methanogens, produce methane gas as a     byproduct, which can be detected through breath testing. Methane can slow the passage of food     through the intestines, which would allow extra time for uptake and absorption of nutrients     and calories, and might contribute to weight gain. The investigators have also found that     people who have increased levels of methane-producing bacteria in their intestines also have     higher levels of glucose in their blood. Therefore, control of how the body responds to     insulin and uses glucose may be altered in methane-producing individuals.      This research study is designed to test the investigational use of the drugs neomycin and     rifaximin that have been approved by the U.S Food and Drug Administration (FDA). While     neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and     hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the toxins     that a healthy liver normally would), and rifaximin is FDA-approved for treating travelers'     diarrhea, they are not yet approved to be used together for the treatment of methanogens or     obesity.   "
125801|NCT01638416|"     In Australia, blood for transfusion has a use by date of 42 days after collection. The     actual age of blood given to patients depends on what is available at the time and the rate     of usage. During the last decade, it has been reported that blood transfusion in patients     admitted to intensive care was associated with an independent increase of mortality. Some     research suggests that transfusion of fresher blood might help patients in the intensive care     unit to reach a better recovery. This project will test whether patients who receive     'fresher' blood do better than patients who receive 'standard issue' blood.   "
125802|NCT01638403|"     3. RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the     generation and organizations of sleep and wakefulness, first described by Westphal and     Gelineau in 19th century. Excessive Daytime Sleepiness (EDS) and cataplexy are two main     symptoms of narcolepsy. Other symptoms referred to as auxiliary symptoms are hypnagogic and     hypnopompic hallucinations, sleep paralysis, dyssomnia and automatic behaviour. The     prevalence of narcolepsy is estimated around 25 per 100 000 in Causasian population. It is     often extremely incapacitating, interfering with every aspect of life, in work and social     settings.      Several breakthroughs in the understanding of physiopathology of narcolepsy have recently     shown that most narcoleptic patients display a strongly decreased CSF level of orexins, a     group of hypothalamic peptides with wake-promoting activity. It was also found that sporadic     narcolepsy in dogs, mice and humans may also be related to a deficiency in the production of     orexin ligands. Narcolepsy may be a neurodegenerative or autoimmune disorder resulting in a     loss of hypothalamic neurons containing the orexin [Baumann CR & Bassetti CL Lancet Neurol.     2005 ; Dauvilliers Y et al, Clin Neurophysiol. 2003 ].      In accordance with guidelines published by the European task force [Billiard M et al, Eur J     Neurol. 2006] , management of narcolepsy with or without cataplexy relies on several classes     of drugs, namely stimulants for EDS, antidepressants for cataplexy and hypnosedative drugs     for disturbed nocturnal sleep. The first line pharmacological treatment of EDS and     irresistible episodes of sleep rely on Modafinil, 100-400 mg/day, given in two doses, one in     the morning and one early in the afternoon, the need for amphetamines and amphetamine-like     stimulants (e.g. methylphenidate) has been decreased. Sodium oxybate and antidepressants are     main drug therapies of cataplexy.      BF2.649, an H3R inverse agonist promotes significantly vigilance in mice knock out for the     orexin gene, a reliable model of narcolepsy, whereas the animals remain calm, a difference     with treatment by amphetamine-like drugs which induce psychomotor excitation. In addition,     BF2.649 shows a significant inhibitory effect on the occurrence of narcolepsy episodes during     the dark period. These narcolepsy episodes are to be compared to cataplexy episodes in human     [Chemelli et al., Cell 1999] 11. In agreement, Modafinil, in humans, does not show any     effects on cataplexy, even if it improves wakefulness by an ill-defined mechanism. Thus     anticataplectic drugs, such as antidepressants, are given in addition to Modafinil to     narcoleptic patients.      Taken together, the preclinical and clinical results provide a compelling rationale for this     study to verify and confirm, under randomized double-blind and placebo-controlled conditions,     the safety and efficacy of escalating dose of BF2.649 in the treatment of EDS and cataplexy     in narcolepsy.      It is on the basis of preclinical studies, and on the observation of the first included     patients, that the doses to be administered were determined.   "
125803|NCT01638390|"     The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl     Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or     elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.   "
140047|NCT01451580|"     To determine the overall objective response rate of pegylated liposomal doxorubicin     （Lipo-Dox）combined with cyclophosphamide/5-FU as second-line treatment in patients with     metastatic breast cancer.   "
125805|NCT01638364|"     The purpose of this study is to examine whether there is an increase in dopamine levels in     the human striatum following an oral administration of alcohol, as has been evidenced in     animal models. This will be a Positron Emission Tomography (PET) study using the radiotracer,     [11C]-(+)-PHNO (11C]-( + )-4-propyl-     3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol).   "
125806|NCT01638351|"     The purpose of this study is to investigate the effect of a 12-week progressive resistance     training program on the skeletal muscle function, glycemic control, functional capacity, and     quality of life in the elderly with type 2 diabetes mellitus.   "
125860|NCT01637649|"     -  This study attempts to elucidate whether stroke patients with dysphagia have reduced          diaphragm movement during voluntary coughing, and also during deep inspiration and          expiration than stroke patients without dysphagia.        -  This study will also compare various spirometric measurements with the diaphragmatic          motions.   "
125809|NCT01638312|"     The goal of this research is the attempt to implement a new research method based on modern     electrochemistry successes, in particular the development of the polarographic method of     fructose and fructose diphosphate identification and its implementation to detect the viral     infection in early stage. There will be 20 samples from the HIV-infected patients and 30     samples from the heath controls. The study will collect 10ml urine and examined fructose and     fructose-diphosphate using the polarographic method.   "
125810|NCT01638299|"     Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize     hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research     setting.   "
125811|NCT01638286|"     A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a     pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy     male subjects.   "
125812|NCT01638273|"     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption     by Extending the Absorption Site.      To overcome the shortcomings of the currently existing sustained release drug delivery     technologies the investigators have recently developed a novel drug delivery system to enable     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).   "
125813|NCT01638260|"     - Rationale: Treatment with glucagon-like peptide 1 (GLP-1) has been shown to reduce plasma     glucose levels to a further extent when added to standard therapy in type 2 diabetes     mellitus. Given the well-known beneficial effects of GLP-1 analogues on glucose metabolism by     stimulating insulin release, suppressing elevated glucagon levels, delaying gastric emptying     and reducing food intake, it is anticipated that liraglutide developed by Novo Nordisk     (Victoza®) also has beneficial effects in type 2 diabetes mellitus as has been proven by     several trials. Type 2 diabetes mellitus is associated with obesity and sedentary lifestyle.     Obesity occurs when energy intake exceeds energy expenditure (EE) over a period of time. It     has been presumed that activity energy expenditure and daily energy expenditure are lower in     most people in Western societies. Increasing non-exercise activity thermogenesis (NEAT),     defined as all energy expended due to everyday activity, exclusive of volitional exercise,     may be an effective way to maintain daily EE and combat overweight and obesity. One way to     promote NEAT is to decrease the amount of time spent on sedentary behaviors (e.g. watching     television).      This leads us to hypothesize that adding NEAT to GLP-1 analogues in type 2 diabetes has an     additive effect on glucose regulation, weight control and blood pressure. On the other hand,     we hypothesize that a decrease in HbA1c, weight and blood pressure could add to an improved     quality of life and less health care costs. Therefore, the primary purpose of this study is     to determine the synergistic effect of liraglutide and activating lifestyle by increasing     NEAT on glucose metabolism and weight. First line therapy of type 2 diabetes mellitus     currently consists of lifestyle changes with metformin. When failure of this regime occurs,     sulfonylurea derivates and/or thiazolidinediones can be added. One third of patients with     type 2 diabetes mellitus fail with this regimen after 5 years of monotherapy, and nowadays     GLP-1 analogues can be added to prevent deterioration of glycaemic control. However,     comparison of this strategy with NEAT has not been performed and the synergistic effect of     combination of GLP-1 with increasing NEAT has not been investigated. Treatment with GLP-1     analogues in combination with NEAT could theoretically overcome all shortcomings of current     treatment strategies of type 2 diabetes mellitus.      Objective:        -  Primary objectives             -  To determine the change in HbA1c from baseline and end of treatment (26 weeks) and               end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus               liraglutide with NEAT             -  To determine the change in weight from baseline and end of treatment (26 weeks) and               end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus               liraglutide with NEAT        -  Secondary objectives             -  To assess the change in blood pressure from baseline and end of treatment (26               weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide               versus liraglutide with NEAT             -  To assess the change in quality of life from baseline and end of treatment (26               weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide               versus liraglutide with NEAT             -  To assess the change in NEAT from baseline and end of treatment (26 weeks) and end               of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus               liraglutide with NEAT             -  To asses the health-care related costs at baseline, after 26 weeks of treatment               with liraglutide versus liraglutide with NEAT, and after 52 weeks (end of               follow-up)      Study design: Randomized controlled intervention study      - Study population: Men and women with type 2 diabetes mellitus, insufficiënt glycaemic     control during maximum (tolerable) dose monotherapy with metformin or a sulfonylurea derivate     or during combination therapy with metformin and a sulfonylurea derivate or a     thiazolinedione, HbA1c above 7,0%, age between 40 - 75 years old, BMI above 25 kg/m2      Intervention: One group receives once daily subcutaneously liraglutide 1.8mg added to     standard anti-diabetic care and the other group receives once daily subcutaneously     liraglutide 1.8mg added to standard anti-diabetic care and an activating lifestyle by     increasing NEAT      Main study parameters/endpoints: The main study parameter is the percent change in HbA1c and     weight. Secondary study parameters are change in blood pressure, quality of life as measured     using EQ-5D and SF-36 questionnaire, NEAT as measured using an activPAL™ accelerometer and     cost-effectiveness analysis.   "
125814|NCT01638247|"     A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or     palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH     analogue in male breast cancer patients (MALE).   "
125815|NCT01638234|"     Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin     may aid sleep and also has anti-inflammatory properties, and has been suggested in managing     sleep disturbance in AD patients. However, there has been no large randomized controlled     trials. Hence the objective of this double-blind randomized controlled study is to determine     whether supplementing melatonin is effective in improving sleep problems in children with AD.   "
125816|NCT01638221|"     This study will be comparing the patients overall satisfaction of two different meshes used     in laparoscopic inguinal hernia repairs.   "
125817|NCT01638208|"     Aim      To compare changes in gut microbiota of IBS patients and healthy controls using next     generation sequencing method like Illumina sequencing based on 16S rDNA profiling.      The major objectives of the study are:      To characterize type of bacterial species and compare diversity of the host's gut microbiota     in 20 Irritable bowel syndrome (IBS) patients with 16 healthy controls (HCs) using high     through put culture-independent method like Illumina sequencing.      To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8     weeks.      To study the improvement of symptoms after modulation of gut microbiota with probiotics (VSL     #3) for more than 8 weeks.   "
125818|NCT01638195|"     This study is a prospective, single-institution trial wherein twenty subjects with refractory     hypertension will receive the experimental focused ultrasound renal denervation therapy.     Safety will be assessed by incidence and evaluation of serious adverse effects associated     with the investigational procedure through 52-week evaluation of bilateral treatment.     Clinical utility will also be evaluated by comparison pre and post therapy systolic and     diastolic blood pressure and norepinephrine spillover.   "
125819|NCT01638182|"     The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins     osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a     nutritional dose range.      The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to     the RDA of vitamin K.   "
125820|NCT01638169|"     During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher     flexion and abduction of the hip in order to advance the swinging limb. The aim of this work     is to assess the immediate contribution of heels for these walking disturbance in children     with muscular dystrophy disease.   "
125821|NCT01638156|"     This study will evaluate the importance of arterial stiffness and wave reflections as     determinants of persistent left ventricular (LV) hypertrophy and fibrosis (assessed using     cardiac magnetic resonance imaging [MRI]) after correction of severe stenosis of the aortic     valve. The hypothesis will test whether stiff arteries and increased wave reflections impede     pumping of blood by the LV after aortic valve replacement (AVR)and precent adequate     regression (improvement) of hypertrophy and fibrosis of the myocardium despite correction of     aortic valve stenosis.   "
125822|NCT01638143|"     The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7)     after intake of three different vitamin K2 supplements.   "
125826|NCT01638091|"     Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New     technologies such as narrowband imaging (NBI) offer the possibility of in differentiation     between precancerous and unimportant small polyps. Use of these technologies could decrease     the costs and potentially the risks of screening and surveillance colonoscopy.      Multiple studies have demonstrated the ability of experienced endoscopists to achieve high     accuracy in differentiating polyp types using NBI.      The investigators hypothesize that community-based endoscopists can learn to identify polyp     type at colonoscopy with the aid of NBI through the use of an introductory didactic program,     followed by practice based-learning, and that their experience can serve as guidelines for     wider dissemination.      The purpose of this study is to test an educational program combining a didactic program     followed by practice-based learning that is designed to allow community-based endoscopists to     become proficient at the use of NBI in the colon. This study will not affect the care of     patients in any way. The research subjects will be the endoscopists, who will perform     colonoscopy and polyp removal in the usual clinical fashion, with the addition of attempting     to predict polyp type before resection.   "
125871|NCT01637506|"     The purpose of this study is to add to the investigators' quest to understanding stone     disease, by evaluating the metabolites excretion in urine and its relation to microflora     present in the stool.   "
125872|NCT01637493|"     The purpose of this study is to examine the safety,tolerability,pharmacokinetics and     pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.   "
125827|NCT01638078|"     Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with     restenosis in approximately 10% to 50% of cases.      Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn     delay healing and endothelialization and may lead to restenosis and atherosclerosis within     the stented segments.      The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory     and antioncogenic properties that could be of benefit in case of PCI with stenting.   "
125828|NCT01638065|"     The objective of this study is to show VeinViewer® Vision is an effective vein visualization     device for peripheral vascular access, pre-, during, and post access.   "
125829|NCT01638052|"     The investigators goal is to determine the efficacy and duration of analgesia with the     addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of     the great auricular nerve in children undergoing tympanomastoid surgery.   "
125830|NCT01638039|"     The aim of this study is to accelerate the development of vaccine candidates against     diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to     identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study     humoral and cellular immune parameters following natural infections with Shigella and ETEC,     and to compare the level of pre-existing local, humoral and cellular immune parameters in     cases of shigellosis and ETEC-associated diarrhea and in matched controls.   "
125831|NCT01638026|"     Study Objectives:        1. To prove that the use of GnHR agonist for final oocyte maturation results in a higher          percentage of mature oocytes than the use of hCG.        2. To show an advantage in women's satisfaction in the proposed protocol versus the          standard antagonist protocol In the study group women will receive GnRH agonist for          oocyte maturation, followed by ovum pick-up which will be performed 35 hours later.          Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will          include HCG 1500 IU. Blood samples for BHCG, progesterone and estradiol will be obtained          14 days after embryo transfer.   "
125832|NCT01638013|"     The purpose of this study is to evaluate the safety and efficacy of long-term administration     of ASP015K in patients who have completed Phase IIb or Phase III studies.   "
125833|NCT01638000|"     The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50     mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied     with their treatment due to lack of efficacy.   "
125834|NCT01637987|"     The purpose of this study is to determine if the use of a vein identification assistive     device increases nurse PIV insertion success within the first two attempts in children 0-12     months of age when compared to unassisted methods.   "
125835|NCT01637974|"     The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine     adhesions formation after any hysteroscopic surgery.   "
125836|NCT01637961|"     This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma     of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
125837|NCT01637948|"     Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease     in China over three thousand years. Certain TCM have scientifically proved to have     anti-bacterial property. Patients having orthodontic treatment have higher risks of caries     and gum diseases. The purpose of this study was to determine whether the use of TCM     Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic     patients in maintaining proper oral health.   "
125838|NCT01637935|"     To assess the potential association between pioglitazone and bladder cancer compared with     non-pioglitazone users among patients with type 2 diabetes mellitus.   "
125839|NCT01637922|"     Otherwise healthy subjects who are currently bein maintained on either methadone or     buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at     least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs     between BI 201335 and either methadone or buprenorphine/naloxone.   "
125840|NCT01637909|"     In hypertension, lifestyle modification has been proven to be effective in reducing blood     pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop     hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic     blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been     shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal     to adding one antihypertensive drug. However, as the dietary pattern is different in the     Korean population, the investigators cannot implement the data from Western countries     directly to the Korean population. For example, the consumption of dairy products is much     smaller in the Korean population when compared to the western population. Therefore, the     effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean     population is not well defined. In this study, the investigators sought to determine the     effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood     pressure lowering. The study will be performed on untreated prehypertension patients and     uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood pressure     measured between 140-159mmHg/90-99mmHg at the time of enrollment.   "
125843|NCT01637870|"     This study is aimed at determining whether or not the use of a wound suction device placed on     the cesarean incision instead of a standard sterile dressing will decrease the prevalence of     wound complications and wound infections in women at high risk for post operative     complications. The study will first look at the infection and wound complication rate in     women 6 months prior to the start date of the study by reviewing charts of women who have     undergone a cesarean section. The study involves placing a single use, portable wound vacuum     over the cesarean section incision and keeping it in place for 72h. The investigators will     then compare the rates of wound infection and wound complications between these two groups.      It is our hypothesis that negative pressure wound systems will decrease the wound infection     and complication rate in this high risk population.   "
125844|NCT01637857|"     Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal     sphincter resting pressure. No studies have investigated a possible role of FH in anal     fissures (AF). We aim to evaluate the effectiveness of a diet in curing AF and the clinical     effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or     wheat.   "
125845|NCT01637844|"     Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen     (HBeAg) have an increased risk of becoming infected with HBV. This study will determine     whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive     pregnant women during the third trimester, in addition to standard immunoprophylaxis in     infants, will be more effective than standard immunoprophylaxis alone at preventing HBV     infections in these infants.   "
125846|NCT01637831|"     The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in     patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published     studies related to CPAP treatment in this patient group. The investigators aim was to assess     the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and     to recognize and overcome possible difficulties in CPAP initiation and acceptance by these     patients.   "
125847|NCT01637818|"     Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh     plug for inguinal hernia repair based on the following published study Randomized clinical     trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg.     2007 Jan;94(1):36-41.      Primary endpoints is recurrence.   "
125848|NCT01637805|"     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of     antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant     adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.   "
125849|NCT01637792|"     The purpose of this study was to explore the impacts of different continuous ambulatory     peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges     CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in     incident Chinese peritoneal dialysis patients.   "
125850|NCT01637779|"     There is no effect of a parent-directed fact sheet about pain management during childhood     immunization and pre-test on parent learning about evidence-based pain relieving methods.   "
125851|NCT01637766|"     Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most     devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal     and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a     clinical entity known as cord compression that manifests with progressive loss of motor     function and sensation in the legs, as well as bladder and bowel incontinence.      The treatment of spinal metastases is mostly palliative with the goals of improving or     maintaining neurologic function, achieving local tumor control, and spinal stability. Most     patients with spinal metastatic disease are currently treated effectively with radiation     therapy and/or surgery with good results. There are however certain limitations in the     current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted     SMD is in close proximity the spinal cord, delivery of high radiation doses is     contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and     2) there is limit on the cumulative amount of radiation dose, which means that recurrent     tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned,     the main limitation is that some patients are not fit for surgery because of medical     co-morbidities.      This phase I clinical research trial will test the hypothesis that a new minimally invasive     treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients     with SMD.   "
125852|NCT01637753|"     The purpose of the study is to determine the safety and efficacy of intracranially implanted     Carmustine in the treatment of patients with recurrent malignant glioma.   "
125853|NCT01637740|"     A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic.     Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS     900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with     those of cataract myopic eyes group without pseudoexfoliation syndrome.   "
125854|NCT01637727|"     The primary goal of this proposed research deals with estimating the risk of developing type     2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a     history of GDM. In addition, this study will attempt to evaluate the effect of parity on the     late appearance of type 2 diabetes and metabolic syndrome in this unique population.   "
125855|NCT01637714|"     The investigators will evaluate the efficacy of multi-strain probiotics in adults with     diarrhea predominant irritable bowel syndrome.   "
125856|NCT01637701|"     The goal of this study is to compare the perioperative and postoperative characters of     plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients     with large prostate.   "
125857|NCT01637688|"     The purpose of this study is to determine growth and protein status of infants with cow's     milk protein allergy and treated with a newly innovated amino acid formula compared to those     with a commercial amino acid formula.   "
126024|NCT01635517|"     The aims of the present study are to investigate prospectively the clinical course and     outcome of the hospitalized heart failure patients treated with tolvaptan for management of     fluid retention and serum sodium levels of less than 140 mEq/L and also to analyze the     factors related with the efficacy including outcome of tolvaptan therapy.   "
125858|NCT01637675|"     Sodium tanshinone IIA sulfonate (STS) is a water-soluble derivative of tanshinone IIA     isolated as the main pharmacologically active natural compound from a traditional Chinese     herbal medicine,the dried root of Salvia miltiorrhiza Bunge known as Danshen. Danshen has     been known for the function of improving body functions such as activating blood circulation     and removing blood stasis according to the theory of traditional Chinese medicine. Danshen     and its various formula products including STS have been long-time widely used in oriental     countries, especially China to treat various inflammatory and cardiovascular diseases for its     pharmacological actions, including vasodilatation, anticoagulation, anti-inflammation, and     free radical scavenging,with negligible adverse effects observed.      The investigator's objective is to evaluate whether STS exhibits beneficial effects on     pulmonary hypertension. This is a randomized, controlled, multicentre clinical trial study.     90 patients with pulmonary hypertension will be enrolled in this study.   "
125859|NCT01637662|"     To investigate headache score and accompanying symptoms during and after infusion of the     natriuretic peptides.   "
125909|NCT01637012|"     To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of     percutaneous coronary interventions in patients with coronary heart disease.   "
125861|NCT01637636|"     The purpose of this research study is to understand whether there is any difference in the     amount of tasimelteon (including its breakdown product) in the blood when taken alone and in     combination with either rifampin or ketoconazole.      Cytochrome P450 3A4 is an important enzyme produced by the body to breakdown certain     medications. In this study, the effect that this important enzyme has on tasimelteon is being     studied by assessing the effect rifampin and ketoconazole have on tasimelteon and how they     are broken down by your body. Rifampin is a known inducer of Cytochrome P450 3A4 enzyme     meaning that it increases the activity of the enzyme. Ketoconazole is a known inhibitor of     Cytochrome P450 3A4 enzyme meaning that it decreases the activity of the enzyme.      In addition, the safety and tolerability of tasimelteon will also be assessed throughout the     study.   "
125862|NCT01637623|"     The purpose of this study is to determine if two medicines (allopurinol and losartan) can     influence heart and blood vessel health compared to placebo in patients with sleep apnea who     are using continuous positive airway pressure (CPAP).   "
125863|NCT01637610|"     The investigators will test the hypothesis that in a preterm population with a gestational     age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than     conventional methods (speculum examination for combination of pooling, nitrazine and ferning)     for the detection of Preterm Prelabour Rupture of Membranes (PROM).   "
125864|NCT01637597|"     This is an exploratory study in patients with locally advanced or metastatic Non-small cell     lung cancer. Patients who are eligible to apply for Extended Access Program of crizotinib     must have ALK translocation detected by RT-PCR, IHC or FISH analyses methods.   "
125865|NCT01637584|"     The overarching objectives of this study are: 1) To investigate the neurobiology of     posttraumatic stress disorder (PTSD) during Rapid Eye Movement (REM) and Non-Rapid Eye     Movement (NREM) sleep relative to wakefulness; 2) To identify the neurobiological     underpinnings of sleep treatment response to prazosin or placebo during wakefulness, REM     sleep, and NREM sleep in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) (     veterans with PTSD; and 3) To explore pre-treatment brain activity patterns during     wakefulness, REM sleep, and NREM sleep that predict sleep treatment response. We will also     explore the stability of the Positron Emission Tomography (PET) signal by comparing pre- and     post-placebo changes in brain glucose metabolism in non-responders. For non-PTSD veterans,     the stability of the PET signal will be evaluated in a subsample of 6 veterans without PTSD     who will repeat the PET imaging procedures 8 weeks after the initial PET series.      The overarching hypothesis is that PTSD is characterized by neurobiological alterations in     the amygdala, medial prefrontal cortex (mPFC), and brain centers involved in the regulation     of NREM and REM sleep, and that these neurobiological changes are normalized with effective     sleep treatment.   "
125866|NCT01637571|"     The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP)     related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would     like to test its effectiveness in treating NCCP.      The patient will undergo esophageal balloon distention testing (EBDT) before and after taking     the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical     properties of the esophagus. A catheter with a deflated balloon is placed through the mouth     and into the esophagus and the balloon is inflated with water. ECG and labs will be done     throughout the study as a measurement of safety.   "
125867|NCT01637558|"     The aims of this project are to:        1. To evaluate the pharmacokinetics of first line antituberculosis drugs (isoniazid,          rifampicin, pyrazinamide and ethambutol) when applying the 2010 WHO/IUATLD dosing          guidelines across pediatric populations (0-12 years of age, HIV infected and uninfected,          and with varied nutritional status) in Cape Town, South Africa and Blantyre, Malawi.        2. To evaluate an 8-hourly weight band-based dosing strategy for lopinavir/ritonavir using          the commercially available lopinavir/ritonavir (4:1 ratio) in children in South Africa          receiving rifampicin-based antituberculosis treatment.        3. To evaluate the pharmacokinetics of nevirapine in children in Malawi receiving          rifampicin-based antituberculosis treatment.   "
125868|NCT01637545|"     Postoperative nausea and vomiting (PONV) is one of the most common and distressing     complications after anaesthesia and surgery, and may lead to serious postoperative     complications This prospective, randomized study designed to evaluate the best injection time     to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3)     antagonist in patients undergoing facial bone surgery.   "
125881|NCT01637376|"     The purpose of this study is to evaluate the safety of I-PDT with Temoporfin for patients     with Non-Resectable Non-Small-Cell Lung Cancer (NR-NSCLC). Several clinical studies suggested     that photodynamic therapy (PDT) may be an effective treatment for patients with NR-NSCLC. PDT     is a therapy where an external light source, such as laser, is used to activate a     light-sensitive medicine to produce byproducts that can destroy cancer cells. In this study     the investigators will use an experimental light sensitive medicine, Temoporfin, to perform     interstitial PDT (I-PDT). In I-PDT, laser fibers are inserted into the tumor to activate the     light-sensitive medicine.   "
125869|NCT01637532|"     The purpose of this interventional study is to determine the feasibility to combine standard     chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy     (Tocilizumab and Peg-Intron).      This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal     antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and     chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer,     therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a     promising strategy to both abolish drug resistance and amplify host immunity in patients with     recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell     death and restore local normal DC maturation. In addition, the use of interferon-alpha     (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response.   "
125870|NCT01637519|"     Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that     drains the bladder), require urgent treatment with a stent to relieve the blockage. This     tube, or ureteral stent, gives the patient relief until they can have their stone treated.     This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones.     This stent is designed to drain the kidney and unlike other ureteral stents, is also designed     to widen the ureter to help the stone pass on its own.   "
125874|NCT01637467|"     Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using     electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in     people who are on bedrest due to critical illness in the intensive care unit. The purpose of     this study is to determine the safety and feasibility of implementing EMS in critically ill     patients who are on mechanical ventilation for greater than 7 days, and examine the effects     of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these     patients. The investigators hypothesize that EMS will be safe and feasible and that     critically ill patients receiving EMS will show a smaller loss of muscle size and strength     than those in the control group, who do not receive EMS.   "
125875|NCT01637454|"     Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal     syndrome (HRS). However, there are very few studies on vasopressors in the management of type     2 HRS. Terlipressin has been used commonly; however it is costly and not available in some     countries. In the present study, the investigators evaluated safety and efficacy of     terlipressin and noradrenaline in the treatment of type 2 HRS   "
125876|NCT01637441|"     The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent     pathology in woman which can impair quality of life and generates pelvic, urinary or sexual     functional disorders.      It's considered that 8 % of women will be undergo surgery in this indication before the age     of 80 years. Numerous surgical techniques have been described and we distinguish the     interventions according to the route (vaginal or abdominal), and according to the use or not     of synthetic mesh (non-absorbable) to increase the anatomical results.   "
125877|NCT01637428|"     The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device)     will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to     compression stockings which is the current gold standard of care.   "
125878|NCT01637415|"     Although there are several tools that can be used to evaluate the severity of ongoing alcohol     withdrawal syndrome (AWS), there is no available tool that can predict which patients are at     risk for developing AWS at the time admission, before the patient has developed AWS.     Unfortunately, there are severe symptoms of alcohol withdrawal (e.g., seizures) which may     develop early in the hospitalization, and before the development of other systemic symptoms     which may warn medical personnel of the possibility of impeding alcohol withdrawal (e.g.,     autonomic instability, delirium). The goal of this study is to evaluate the psychometric     properties (e.g., predictive validity) of a new tool, the Prediction of Alcohol Withdrawal     Severity Scale (PAWSS), on identifying which patients are at risk for developing complicated     AWS (i.e., seizures, hallucinosis, delirium tremens) among hospitalized, medically ill     patients.   "
125879|NCT01637402|"     The purpose of this study is to find out what effects, good and/or bad,an increased dose of     Abiraterone Acetate in combination with prednisone has on patients and their prostate cancer.     This study will investigate whether an increased-dose (2,000mg daily) is safe and potentially     effective when given to patients whose cancer has grown while taking the standard dose.   "
125880|NCT01637389|"     Fundacion Cantaro Azul (FCA) is a non-profit organization in Baja California Sur, Mexico     (BCS). Since 2006 FCA has piloted a safe drinking-water program in rural regions of BCS. The     premise of their safe drinking-water programs has been the installation of household     drinking-water disinfection systems which utilize an ultra-violet technology (UV) developed     at the University of California, Berkeley. While the systems have been tested for safety and     effectiveness at inactivating waterborne pathogens, FCA is interested in rigorously     evaluating the impact of their safe drinking-water program at the population level. FCA is     looking to expand their safe-water program during 2009 and 2010 to newly identified     communities that lack safe-drinking water. In order to evaluate the community level     effectiveness of their program FCA has agreed to randomize the timing of this expansion which     will allow the lead investigators and key personal in this protocol to conduct a meaningful,     scientific evaluation of the impact of their program through a randomized stepped wedge     design.      The research described in this protocol has four (4) primary objectives:        1. To evaluate the impact the implementation of the safe drinking-water programs has on          rates of gastrointestinal events in rural BCS communities;        2. To evaluate the impact of the safe drinking-water programs on concentrations of fecal          contamination in household drinking-water in rural BCS communities;        3. To evaluate other-health and non-water impacts on communities where the safe-water          programs are implemented, including school and work absenteeism, and health care costs;        4. To identify household, program and system design characteristics that affect user          compliance with the disinfection strategies.      The investigators hypothesize that households that receive an UV based drinking-water     disinfection system through the safe-water program will have reduced prevalence of     gastrointestinal illness, and reductions in fecal contamination of household drinking-water,     measured as concentrations of Escherichia Coli per 100 ml of water. Similarly, the     investigators hypothesize that these communities will also have reduced health care costs,     and school and work absenteeism due to the implementation of the safe drinking-water     programs. The investigators further hypothesize that household level characteristics and     specific program characteristics will differentially impact user compliance, measured as the     sustained use of the systems over the course of the study. In order to evaluate the last     hypothesis (Objective 4) two program variations will be rolled out to inform future     programmatic decisions. A priori the investigators do not anticipate that these program     variations will impact population measures for Objectives 1 and 2, but the investigators will     explore these assumptions during analysis.   "
125882|NCT01637363|"     In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick     leave due to psychiatric sufferings. Mental health conditions are of great consequence not     only to the sick-listed individual but also to his/her family and to society in general and     in socioeconomic terms.      The aim of this project is to systematically compare psychoeducation with the various     standard offers to sick listed individuals with mental health conditions provided by job     centers in four municipalities.      Psychoeducation is employed within the psychiatric healthcare system and is defined as a     group based treatment by means of educating participants about psychiatric conditions. In the     present project, the employed psychoeducation focuses on psyche and work life, and its     purpose is to impart knowledge about psychiatric conditions in order to provide the sick     listed individuals with qualifications to understand, and, thereby, improve their own     situation. Among others, there will be information about the symptoms of various psychiatric     conditions, diagnoses, and treatment options. Furthermore, the participants will learn about     specific, useful, cognitive tools in regards to the barriers and difficulties they might     experience when reentering the work force and leave sickness absence behind.      The project is designed as a randomized clinical trial in which the participants are offered     either 1) psychoeducation as well as the standard offer to sick listed individuals provided     by the municipality in which the individual lives or 2) the participants are offered merely     the standard offer to sick listed individuals provided by the municipality.      The target group consists of recently sick listed individuals with mental health issues -     whether diagnosed or not. The individuals must be inhabitants of the municipalities of     Struer, Lemvig, Skive, and Holstebro.      The outcome measure is the determined as the duration of the sickness absence, the severity     of the psychiatric condition, self-reported health, and `locus of control´. These outcome     measurements are assessed at baseline and after 3 and 6 months.   "
125883|NCT01637350|"     Different digestive tract reconstruction will affect the blood glucose level of gastric     cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total     gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which     includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C     -peptide and body weight of gastric cancer patients with type 2 diabetes.   "
125884|NCT01637337|"     To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in     patients with >3cm renal pelvis stone.   "
126029|NCT01635452|"     This is a multi-center, prospective, non-interventional study of patients who have been     diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a     pre-operative treatment with ESMYA.      The objectives of the study are to characterize and describe treatment with ESMYA and to     evaluate the safety, effectiveness, and HRQL outcomes in this population   "
125885|NCT01637324|"     Objectives        1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV          voluntary counseling and testing (VCT)        2. To determine the impact of MSM-targeted multidisciplinary services on the enrollment          into care and retention of HIV-positive MSM      Subject population: HIV-negative and HIV-positive MSM clients, age ≥18 years old, of the Thai     Red Cross Anonymous Clinic (TRC-AC) in Bangkok Thailand, the Cipto Mangunkusumo Hospital in     Jakarta, and the Sanglah Hospital in Bali, Indonesia      Number of participants: 200 HIV-negative and 150 HIV-positive MSM participants   "
125886|NCT01637311|"     Achalasia is a rare esophageal motility disorder, which is characterized clinically by     symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term     efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide     acceptance as the procedure of choice for the management of patients with primary achalasia     in recent years. Although good or excellent long-term symptomatic response rates can be     achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms     occurs in approximately 20%. Controversy exists regarding the therapy of patients with failed     success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a new     minimally invasive endoscopic myotomy technique intending a permanent cure from primary     achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients     with failed HM.   "
125887|NCT01637298|"     The goals of this application are to assess the usefulness of biomarkers, including p16     proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV)     types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying     HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by     anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it     will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months,     and perform HRA and biomarkers on all clients at baseline and every 12 months. Information     from this study would inform AIN screening and follow up approaches in HIV-positive and     HIV-negative MSM in both resource-limited and resource-rich settings.   "
125888|NCT01637285|"     The purpose of the study is to further evaluate the PK characteristics of PF-04856883.   "
125889|NCT01637272|"     multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide     in patients with dumping syndrome   "
125890|NCT01637259|"     Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV.     Antiretroviral therapy associated renal dysfunction has been predominantly described in terms     of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur     in the absence of significant reductions in eGFR. This substudy is an exploration of changes     in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and     safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase     inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with     stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of     combination antiretroviral therapy (cART).   "
125891|NCT01637246|"     This is a retrospective chart review and will assess changes in IOP after treatment with any     fixed combination in patients who previously received monotherapy.   "
125892|NCT01637233|"     This substudy is a prospective, observational, open-label, randomised study within the MARCH     study. The purpose of this substudy is to investigate the changes in cerebral function     parameters at 5 timepoints over 96 weeks of the three different treatment arms within the     MARCH study. The investigators hypothesise that there will be improvements in cerebral     function in those patients randomised, as part of the parent study, into the maraviroc arms.      the assessments in this CNS substudy will include:        1. Neurocognitive function as assessed by a computerised testing battery called CogState;        2. changes in cerebral metabolites as measured via 1H Magnetic Resonance Spectroscopy          (1H-MRS)      In those randomised to the maraviroc arms (arms 2 and 3) there is an optional Lumbar puncture     at week 48. The cerebrospinal fluid will be used to measure maraviroc levels and an     ultrasensitive CSF HIV-1 viral load. These results will be matched with levels in the plasma.   "
125903|NCT01637090|"     CTCL is a rare form of lymphoma of the skin. While early stages are usually confined to the     skin, later stages may spread to blood, lymph nodes and other organs. At this point, patients     usually require systemic chemo. This study will investigate the effect of everolimus as     treatment for recurrent or refractory CTCL. Participation in this study will last as long as     the study doctor believes disease has not gotten worse, and patients continue to tolerate the     study medication for a maximum of 1 year. Once off the treatment, patients will be followed     for two years.   "
125893|NCT01637220|"     In about 10% of preoperative anaphylactic reactions to curare (114 patients analyzed at the     BICHAT Hospital), a classical mechanism (mast cell- and IgE-dependent) is not identified. The     mechanisms underlying these atypical anaphylactic reactions are unknown. The investigators     have developed at the Pasteur Institute a murine model of anaphylaxis in which neutrophils,     IgG and Platelet Activating Factor (PAF) play predominant roles. In addition, preliminary     results obtained at the BICHAT Hospital suggest the presence of specific IgG anti-quaternary     ammonium in the sera of patients that had developed a shock to curare anesthesia, but not in     controls exposed to curare anesthesia or in normal blood donors. Finally, the release of     neutrophil extracellular traps (NETs), extracellular filaments made of DNA and histones, may     contribute to respiratory symptoms.      HYPOTHESIS: Neutrophils are implicated in curare-induced anaphylactic reactions in humans.     Activated by IgG-curare complexes, which aggregate IgG receptors, neutrophils release PAF and     NETs that are implicated in the cardiac and respiratory distress during anaphylaxis. It is     possible that the activation of neutrophils: 1) explains the clinical features of atypical     anaphylactic reactions (non-IgE mediated), 2) participates also in part to classical     anaphylactic reactions      GENERAL OBJECTIVE: Compare the percentage of circulating activated neutrophils in a group of     patients immediately following a curare-induced shock (case) to that of a group of patients     exposed to curare during anesthesia without developing a shock (control).      SECONDARY OBJECTIVES: A) the day of the shock, quantify and compare between case and     controls, 1) the level of circulating anti-quaternary ammonium IgG by immuno fluorometry, 2)     the expression of IgG receptors (FcR) on the surface of neutrophils by cytometry, 3) the     levels of circulating PAF by mass spectrometry, 4) the amount of NETs by immunofluorescence.      B) 6 to 10 weeks after the shock perform, 1) cutaneous tests to curare, 2) a study of the     capacity of stimulation of ex vivo neutrophils by IgG-curare complexes   "
125922|NCT01636843|"     This trial is conducted in Europe, North America and South America. The aim of this trial is     to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared     to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to     patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate     (MTX) while on a stable background of MTX therapy.   "
125923|NCT01636830|"     The objective of this study is to evaluate the incidence of gingival fissures according to     the type of brush used, soft and medium.   "
125894|NCT01637207|"     The Investigators aim to determine how easy it is for anaesthetists to identify the     Cricothyroid membrane (CTM) in children and infants and whether ultrasound maybe useful in     addition. The investigators aim to conduct a randomised single blinded trial to compare     methods to detect the CTM.      The first group of patients will be randomised to palpation of anatomical landmarks group.     Prior to commencing the MRI scan the anaesthetist is timed to identify the CTM and then the     trachea using a felt tip pen. A ficidual marker will be placed on the 2 marked areas.      The second group of patients will be randomised to receive ultrasound. Prior to commencing     the MRI scan the sonographer is timed to identify the CTM and then the trachea using a felt     tip pen. A ficidual marker will be placed on the two marked areas.   "
125895|NCT01637194|"     This phase I trial studies the side effects and best dose of cetuximab when given together     with everolimus in treating patients with metastatic or recurrent colon cancer or head and     neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different     ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and     help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of     tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus     may be an effective treatment for colon cancer or head and neck cancer   "
125896|NCT01637181|"     A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA)     techniques in patients with insufficiency of the great saphenous vein (GSV). There are     multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode     and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be     equally effective in occluding the GSV. However, little is known about differences in     patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial     of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health     related and varicose-specific questionnaires. The secondary outcomes are complications and     effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower     pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in     complication rate and effectiveness between the two treatments.   "
125897|NCT01637168|"     The purpose of this study is to evaluate the efficacy and safety of two different drugs in     the treatment of patients diagnosed with memory difficulties and a decline in cognitive     function.      This is a parallel distribution: a group of patients will be treated with a combination Panax     Ginseng + Ginkgo Biloba + multivitamin + Polyminerals (EMS), and another group with Ginkgo     Biloba (Tebonin ®).   "
125898|NCT01637155|"     Set the pattern of vitamin D supplementation in obese patients undergoing bariatric surgery     in deficit of vitamin D.      Patients receive a single oral dose of vitamin D, during the 28 days will be done a kinetic     curve. Then and over the next 3 months, levels are normalized. Once normalized, will be     administered another single oral dose to a second pharmacokinetic evaluation.   "
125899|NCT01637142|"     The purpose of this study is to assess the extent and rate of absorption of LY2140023 in     healthy participants. The study has two periods. In Period 1, participants will receive a     single oral dose of 80 mg LY2140023 followed by a 2-hour intravenous (IV) infusion of     approximately 100 micrograms (µg) LY2140023 containing approximately 100 nCi [14C]-LY2140023.     In Period 2, participants will receive an oral dose of 80 mg LY2140023 followed by a 2-hour     IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi [14C]-LY404039.     There will be at least a 3-day washout between doses.   "
125900|NCT01637129|"     This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test     tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal     stroke.   "
125901|NCT01637116|"     The primary purpose of this study is to identify and characterize novel diagnostic markers     for autoimmune urticaria, a subset of chronic spontaneous urticaria.      Additional aims: include the comparison of the clinical profiles of autoreactive, autoimmune     and non autoreactive / autoimmune urticaria and the quality of life impairment in these     subsets of chronic spontaneous urticaria.   "
125902|NCT01637103|"     Depressive symptoms are highly frequent among cancer patients. These symptoms significantly     impair quality of life (e.g., hopelessness, greater risk of suicidal behaviours) and may even     affect patients' prognosis (e.g., through decreased adherence to cancer treatments).     Cognitive therapy (CT) is an established treatment for depression in the general population,     but its efficacy has not yet been investigated in non-metastatic cancer patients.     Furthermore, because the accessibility to CT is very limited in routine cancer care and     because many patients are reluctant to use pharmacological treatment, they often turn to     alternative treatments such as bright light therapy (BLT), but empirical data on its efficacy     are needed before its use can be recommended. Goal 1: To assess at post-treatment, as     compared to a waiting-list control condition, the effect of bright light therapy (BLT) and     cognitive therapy (CT): (1a) in reducing depressive symptoms; and (1b) in improving     subjective and objective sleep parameters, in reducing fatigue and anxiety and in increasing     patients' functioning and quality of life. Goal 2: To compare at post-treatment and at 3- and     6-month follow-ups the effect of BLT and CT : (2a) in reducing depressive symptoms; and (2b)     in improving subjective and objective parameters of sleep, in reducing fatigue and anxiety     and in increasing patients' functioning and quality of life. It is hypothesized that, As     compared to control patients after their waiting period, both BLT and CT groups will have     significantly greater improvement of all symptoms at post-treatment. However, as compared to     BLT patients, CT patients will show greater improvements of all symptoms at post-treatment     and at 3- and 6-month follow-ups. This study will provide empirical data on the efficacy of     two approaches for treating depressive symptoms in cancer patients in order to better inform     the scientific community, health care providers, and patients on the most effective     depression treatments to implement in cancer care.   "
140048|NCT01451567|"     The purpose of this study is to examine the effect of a structured personalised ergonomic     intervention program for hospital nurses with musculoskeletal complains.   "
125905|NCT01637064|"     By creating a registry, physicians will have the opportunity to understand the clinical     outcomes of Myositis patients treated with Acthar. Despite the availability of clinical     exams, muscle biopsies, and other testing, it is surmised that there may be a more important     classification of myositis that physicians are not diagnosing which could possibly lead to     improper treatment due to inaccurate diagnosis. There may be several types of immune and     inflammatory myositis (IIM) that do not fit well into the typical sub classifications of     myositis.   "
125906|NCT01637051|"     In a prospective randomised study two uncemented tibial components with different     polyethylene modularities (Trabecular Metal Technology (TMT) Zimmer NexGen® monobloc and TMT     Zimmer NexGen® modular) used for total knee arthroplasty (TKA) is evaluated. Both tibial     component coatings are designed to provide excellent condition for bone ingrowth.      The differences between the two tibial components are evaluated by measurements of migration     of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the     adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry     (DEXA).   "
125910|NCT01636999|"     Nitrous oxide (N2O) has been used for the treatment of labor pains for over 150 years. The     longevity of its use in clinical practice can be attributed to its excellent safety profile,     ease of administration, and familiarity of use among health-care providers. Sedara is a     self-administered 50% N2O, 50% oxygen gas mixture with pain relieving and anxiety reducing     properties recently available for use in the United States (US) to treat various painful     clnical situations, including labor pains.      In the US, epidural or intravenous administration of narcotic medications is one of the most     common and frequently requested treatments for patients experiencing labor pains. Although     generally considered safe, complications are common with epidurals, including fetal distress,     low blood pressure in the mother, respiratory distress, and headache. In our hospital system,     the use of the synthetic intravenous painkiller, Butorphanol, is a mainstay of treatment for     labor pains. It too can have undesirable side effects in the mother, including low blood     pressure and breathing problems.      Because Sedara has until recently been unavailable in the US, studies comparing its efficacy     with other agents for labor pain have been confined to Europe, predominantly in the United     Kingdom. Several studies have investigated the efficacy of Sedara versus inhalation and     intravenous anesthetics in various countries. We have obtained several Sedara devices for use     in the West Penn Allegheny Health System (WPAHS) Department of Anesthesiology and would like     to examine its efficacy in our target population of women experiencing pain during early     labor.      Hypothesis - Sedara will provide equivalent or superior pain relief among term, adult     parturients in early labor (less than 5cm cervical dilation) compared to intravenous     butorphanol.      Primary aim - Compare Sedara versus butorphanol in a single-blinded randomized trial with the     main outcome measure being reduction in labor pains at various time intervals.      Our findings may be significant in terms of improving safety and efficacy of pain relief     among women experienceing labor pains. Given that Sedara has not been previously studied in     the US, the results may influence current obstetrical and pain management practices.   "
125911|NCT01636986|"     The purpose of this study was to evaluate the performance of a novel silicone hydrogel     contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY     ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact     lens-related dryness symptoms.   "
125912|NCT01636973|"     A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes     patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of     oxygenation and protection of airway damage. However, there is a lack of study about the     effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung     ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation     and respiratory mechanics during one-lung ventilation .   "
125913|NCT01636960|"     This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN     alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after     definitive surgical resection including complete lymphadenectomy. Participants on this study     will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to     receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit     (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a     weekly basis is safe and tolerated.   "
125914|NCT01636947|"     This is an efficacy and safety study to compare aprepitant with ondansetron for the     prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy     (MEC) in participants with solid tumors. MECs include a number of commonly used cancer     chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based     regimens.      The primary hypothesis of this study is that the Aprepitant Regimen is superior to the     Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting     Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.   "
125915|NCT01636934|"     The goal of this clinical research study is to learn if minocycline can reduce the side     effects reported by patients with NSCLC who are receiving chemoradiation therapy. In this     study, minocycline will be compared to a placebo.      Minocycline is an antibiotic that may help to reduce side effects of chemoradiation therapy.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
125916|NCT01636921|"     The Phase II goal of this clinical research study is to find the efficacy of this combination     assessed by tumor response and local progression failure.   "
125917|NCT01636908|"     The purpose of this study is to determine intratumoral concentration of kinase inhibitors     upon 2 weeks of treatment in tumor tissue of patients.   "
126045|NCT01635244|"     The purpose of this study is to:        1. Assess for hemodynamic differences at rest and with exercise between three clinically          available tissue aortic valves.        2. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV          hypertrophy, and changes in LV systolic and diastolic function) after aortic valve          replacement for severe aortic stenosis (AS) between three clinically available aortic          valve bioprosthesis.   "
125918|NCT01636895|"     The study has two components: component A is a cohort study to determine the in vivo efficacy     of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component     B is a cross sectional study of women delivering at the study hospitals to assess the     effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context     of increasing SP resistance. Results of component A and B studies will be used to model the     relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy     to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine     monitoring effectiveness of SP-IPTp as part of ANC surveillance.   "
125919|NCT01636882|"     This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA     007 trial. There may be patients who have benefitted from the study drug and who might     benefit from further treatment. In order to accommodate those patients further treatment to     complete 48 weeks of CVA21 intratumoral injections will be made available.   "
125920|NCT01636869|"     Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot     femoral nerve block and periarticular block, so we would like to know the plasma     concentration of bupivacaine in these patients.   "
125921|NCT01636856|"     Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea.     Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator,     breathing exercise and nasal lavage. The objectives are study the effects of therapy on     oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on     snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative     expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal     exercises) will have more modifications compared to the control group.   "
125968|NCT01636245|"     The purpose of this study is to evaluate the immunogenicity and safety of three consecutive     lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.   "
125924|NCT01636817|"     This trial is conducted in Europe, North America and South America. The aim of this trial is     to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared     to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to     patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa     biologics and are on a stable background of methotrexate (MTX) therapy.   "
125925|NCT01636804|"     On April 2, 2012 the manufacturer of the Quicksite® and Quickflex® leads, St. Jude Medical,     released a voluntary medical device advisory regarding these leads' potential for problems     with the silicone insulation covering one end of the lead, where it meets another section of     the lead which is coated with a different insulating material (polyurethane). There has been     a voluntary suspension of sales of these leads.      There are approximately 179,000 of the above leads implanted worldwide with an estimated     101,000 leads currently in service (59,000 in US). There have been 39 confirmed cases of the     conductor portion of the lead becoming exposed from the silicone insulation     (externalization), and the rate of occurrence of this type of problem is conservatively     estimated at less than one percent. However, a review done by St. Jude Medical of returned     Quicksite® and Quickflex® leads and available X-ray and fluoroscopic (x-ray movie) images of     patients with these leads (from 1,219 patients) revealed a higher rate of 3-4%. It is     presumed that there are patients whose leads have not yet been affected by this problem, but     whose leads may show signs of structural changes on x-ray or fluoroscopy. This study seeks to     determine what structural changes may be occurring in these leads, what signs might predict     these changes, and what impact these changes may have on the lead and its performance.   "
125926|NCT01636791|"     Background: Common mental illness, such as anxiety disorders and depression, is the main     cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be     effective in alleviating target symptoms of these disorders, but its effect on sick leave     rates has not been sufficiently addressed. The investigators have developed an intervention     called return to work (RTW), which is based in cognitive behavioral theory, that has a     primary aim of helping sick-listed patients with common mental illness return to work. This     new treatment has not been evaluated in a randomized controlled trial.      Aims: The aim of this study is to investigate the effect of CBT and RTW for common mental     illness in a randomized controlled trial conducted in primary care. Participants will be     randomized to diagnosis specific CBT (n=70), RTW (n=70), or a combination of the two     treatments (n=70). Main outcomes are days of sick leave and clinician severity rating of     psychiatric symptoms. This study could contribute to new knowledge regarding how to best     treat patients on sick leave with common mental illness.   "
125927|NCT01636778|"     The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts     in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count <80,000     /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy     and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient     to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy     with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate     to a higher rate of sustained viral response.   "
125928|NCT01636765|"     This is a study to evaluate inter- and intra-rater reliability of the Clinician Erythema     Assessment Scale. There is no treatment (intervention) associated with this study.   "
125929|NCT01636752|"     Care for people suffering from depressive symptoms should be given in a step-wise approach.     One first step can be the provision of self-help material. Online self-help is an innovative     way of providing self-help. The investigators want to study the effect of an interactive     online self-help-program (Deprexis) in the treatment of mild to moderate depressive symptoms.     Participants will be randomised to either twelve weeks of online-self help or a waiting-list     control. Symptoms of depression and other aspects will be assessed over a one year period.     Thereafter the controls will also receive online-self help. The investigators hypothesise     that online self-help is superior to the control condition in alleviating depressive symptoms     and preventing full blown depression.   "
125935|NCT01636674|"     The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission     Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer.     Furthermore, the investigators combine 18F-FDG PET findings with clinical and     histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and     measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict tumor     recurrence.      The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and     pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging     of disease and early detection of recurrence.   "
125936|NCT01636661|"     The primary objective of this proposal is to investigate the safety of use of transcranial     Direct Current Stimulation (tDCS)in children with hemiparesis.      The research question, Is transcranial Direct Current Stimulation safe for use in children     with congenital hemiparesis? relates to two hypotheses:        1. tDCS will not produce a major adverse event, including seizure activity.        2. No change in paretic or nonparetic hand function or cognitive status will occur.   "
125937|NCT01636648|"     This was a prospective, non-randomized, multi-center, non-interventional post-market study.     The study was a post-market long-term follow-up study based on the same cohort of patients     (148 patients) enrolled in a previous investigational study from March 2007 to December 2009     (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites.     Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment.     Medtronic ATS Inc. retained the right to terminate this study at any time after the 5 year     followup.      The primary objective of this study was to evaluate the safety and effectiveness of the     Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.      As this was an observational study, safety and efficacy data were summarized and described.     There was no statistically powered study hypothesis.   "
125938|NCT01636635|"     The purpose of this study is to evaluate the effect of aging and weight loss on iron status     and immune response in obese women. Iron deficiency and immune impairment are two of the     numerous complications of obesity. The central hypothesis is that obesity-induced     inflammation causes lower iron status through decreased iron absorption and availability in     young and older obese women. Furthermore, the investigators hypothesize that this can be     corrected with weight loss in both young and older obese women.   "
125939|NCT01636622|"     The goal of this clinical research study is to find the highest tolerable dose of vemurafenib     that can be given in combination with carboplatin and paclitaxel patients with advanced     cancer. The safety of the study drug combination will also be studied.      Vemurafenib is designed to block a protein (called mutated BRAF) that is only found in moles     (spots) of the skin and certain types of cancer cells. This drug may slow the growth of or     kill these cells.      Carboplatin is designed to slow the growth of cancer cells by stopping them from making new     DNA (the genetic material of cells).      Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into     new cells.   "
125940|NCT01636609|"     The goal of the Phase 1 part of this clinical research study is to learn the highest     tolerable dose of cytarabine that can be given with tosedostat and the highest tolerable dose     of 5-azacitidine that can be given with tosedostat to patients with AML or MDS.      The goal of the Phase 2 part of the study is to learn if cytarabine with tosedostat and/or     5-azacitidine with tosedostat can help to control the disease. The safety of these     combinations will continue to be studied.      Tosedostat is designed to block the production of proteins that cancer cells need to grow.     Blocking these proteins may cause the cancer cells to die.      Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop     the DNA from repairing itself.      5-azacitidine is designed to block certain proteins in cancer cells whose job is to stop the     function of the tumor-fighting proteins. By blocking these proteins, the tumor-fighting genes     may be able to work better.   "
125941|NCT01636596|"     The objectives of this project are to examine amyloid burden and cognition in a group of     subjects diagnosed with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) before     and after a six month course of insulin delivered weekly in a controlled pulsatile     intravenous fashion in a clinical setting. The investigators central hypothesis is     straightforward: The investigators predict that controlled pulsed IV infusion of insulin will     improve cognition in patients with AD, and that this improvement will be correlated with a     decrease in amyloid burden in these patients.   "
125942|NCT01636583|"     A water purifying system, called LifeStrawFamily (LSF), able to fortify water with zinc to a     concentration of 4 mg/l has been developed. The aim of this study is to investigate whether     the LSF strategy is advantageous in terms of zinc absorption compared to food fortification.     This study wants to demonstrate whether aqueous zinc produced by the LSF device consumed     within or outside meals is better absorbed than zinc from an enriched cereal-based staple     food in healthy adults. In addition, the zinc absorption from the LSF-enriched water and from     a fortified inhibitory cereal-based pudding will be compared.   "
125943|NCT01636570|"     The purpose of this study is to determine if treatment with vitamin D3 of 10,000     International Units (IU) daily in vitamin D deficient patients for 6 months will improve B     type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The     investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated     by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in     patients with stable congestive heart failure (Class II or III).   "
125944|NCT01636557|"     The main purpose of this study is to evaluate the potential effects of a single dose of     sirukumab on the pharmacokinetics (what the body does to a drug) of study agents that are     specific for cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, and CYP1A2) in patients     with active rheumatoid arthritis (RA). This study will also assess the safety and     tolerability of a single subcutaneous (SC, under the skin) dose of sirukumab in patients with     active RA.   "
126046|NCT01635231|"     Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium-     and water channels in the human kidney.      Changes in the sodium-and water channel activity can be induced by blocking the sodium     channels with diuretics in healthy subjects   "
126047|NCT01635218|"     The aim of this study was to determine whether individualized homeopathic treatment and     fluoxetine are more efficient than placebo for moderate to severe depression in peri- and     postmenopausal women.   "
125945|NCT01636544|"     Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses.     Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco     consumption have been recognized for years as the main risk factors for development of OSCCs.     However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers.     Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies     have suggested the possibility that a virus could be associated with or be a causal agent of     OSCC. The first objective is to detect and characterize the presence of infectious agent     (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The     secondary objectives are (i) to associate and (ii) if possible define a causality link     between these agents and a subset of potentially malignant disorders and/or OSCCs.   "
125946|NCT01636531|"     This multi-center, randomized, open-label, single-dose, parallel group study will assess the     relative bioavailability, tolerability and dose-exposure relationship of a high concentration     liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832)     in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of     either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.   "
125947|NCT01636518|"     Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper     chambers of the heart (called atria) and is often associated with many health problems. It     can cause stroke, palpitations and heart failure. The management of long standing (chronic)     AF may require additional medications and blood thinners, potentially for life. It may also     require procedures where the heart is shocked with an electrical current to restore normal     rhythm. Some patients require a procedure called radiofrequency ablation to address the     arrhythmia.      The purpose of this registry is to collect information on patients undergoing this     combination of procedures into a database, and to then use this information for scientific     study to improve the treatment of atrial fibrillation.   "
125999|NCT01635842|"     To understand the patients' meaning of the informed consent process in clinical trials.      Objective of the study is:        -  to assess, in a cohort of subjects included in clinical trials, whether the information          and the informed Consent Forms conveyed to the patients have been understood        -  to assess whether the choice to participate in a clinical trial is informed and aware   "
125948|NCT01636505|"     The aim of this study is to performed a randomized controlled trial to evaluate the rate of     genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and     GnRH-antagonist ovarian stimulation protocols.      Patients will be prospectively randomized in two groups: the first undergoing controlled     ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist     ovarian stimulation regimen.      The end-points of the study include the number of genetically and chromosomally abnormal     embryos, the pregnancy, the implantation and the healthy baby birth rate.      The patients included in PGS program were selected on the base of advanced maternal age,     repeated pregnancy lost and implantation failure whereas the patients who were know to carry     sex-linked or monogenic disorders were considered for PGD strategy.      The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the     exclusion factors.   "
125949|NCT01636492|"     This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the     safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male     volunteers. Subjects will be randomized in cohorts to receive single oral doses of either     bitopertin or placebo.   "
125950|NCT01636479|"     Primary Objectives:        -  To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the          characterization of dose-limiting toxicities (DLTs).        -  To assess biological activities in patients with dedifferentiated liposarcoma during MTD          cohort expansion.      Secondary Objectives:        -  Pharmacokinetic (PK) profile of SAR405838.        -  Biomarkers in association with SAR405838.        -  Anti-tumor activity in response to SAR405838.        -  Food effect on SAR405838 PK.        -  Compliance with SAR405838 treatment.        -  Cytochrome P450 3A4/5 (CYP3A4/5) activity.   "
125951|NCT01636466|"     The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®)     in preventing antibody formation in patients with chronic failing kidney transplants.     Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the     prevention of rejection in kidney transplant.      The primary objective for the study is to determine whether conversion of patients with     chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent     allosensitization. The secondary objective will be to determine whether conversion of     patients with chronic renal graft failure to everolimus (elimination of calcineurin     inhibitor) will delay the onset of dialysis.   "
125952|NCT01636453|"     To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive     treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal     carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent     and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck,     saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath     and a delivery wire assembly. The implant component is made of superelastic and biocompatible     nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial     aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid     terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating     segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved     embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a     dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6 and 12 months     after enrollment.   "
125953|NCT01636440|"     Conditioned pain modulation is the ability of the spine to describe changes in pain     perception, if two different painful stimulations take place. The reliability of the     conditioned pain modulation has not been studied, the instruments used to measure the     conditioned pain modulation are sparse and have proven difficult to use in a well     reproductible way. This study is using an existing pain test, relying on the reflex in a     muscle after a painful electrical stimulation. We will test 34 healthy volunteers in order to     test the reliability of the conditioned pain modulation with the nociceptive withdrawal     reflex combined to a ice water test.   "
125954|NCT01636427|"     The purpose of this study is to assess differences in the risk profile and in the coronary     angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between     myocardial infarction presentation and renal function will be investigated.   "
127951|NCT01610284|"     The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant     is effective and safe in treating patients with hormone receptor-positive, HER2-negative     locally advanced or metastatic breast cancer refractory to aromatase inhibitor.   "
125955|NCT01636414|"     It is widely reported that a large percentage of total joint replacement patients receive     allogeneic (human donor blood) blood transfusions due to perioperative blood loss with     numbers ranging from 30% to 80%.      The risks of allogenic blood transfusion are well documented in the literature. In addition,     they are time-consuming: often lengthening hospital stay and decreasing the availability for     postoperative physical therapy. Moreover, they are costly at several hundred dollars per     unit, and allogeneic transfusions are linked with immunosuppression and increased     postoperative infection rates and wound healing problems, which are devastating complications     in this elective, joint replacement population. Several options are available for diminishing     the need for allogenic blood transfusion following elective total joint replacement. These     include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While     there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint     arthroplasty, there is little information comparing one versus the other in terms of efficacy     and economics.      The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac     drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee     replacement surgery.   "
125956|NCT01636401|"     The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of     aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic     obstructive pulmonary disease (COPD).   "
126000|NCT01635829|"     The purpose of this study is to investigate the potential pharmacokinetic (what the body does     to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or     carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state     (constant concentration of medication in the blood) in healthy participants.   "
125957|NCT01636388|"     The investigators intend to utilize reduced intensity conditioning and allogeneic stem cell     transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post     AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV     positive patients with poor risk Hodgkin Lymphoma. One of three reduced intensity     conditioning regimens predetermined at each institutional center of the Childhood, Adolescent     and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for related or     matched unrelated adult donor allogeneic transplant followed by donor LMP specific CTL     infusion for three doses post AlloSCT. The investigators hypothesize that the addition of     donor derived LMP specific CTLs will be safe and feasible.   "
125958|NCT01636375|"     This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific     aims of this project are three-fold. First, the investigators intend to compare the amount of     muscle atrophy and tendon damage that occurs around the hip between two commonly-used     operative approaches: the direct-anterior approach and the posterior approach. Second, the     investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage     that should reasonably be expected to occur with both of these approaches. Third, the     investigators will document the degree of recovery of the periprosthetic soft tissues     post-surgery in both patient groups.      The investigators first hypothesis is that the posterior approach will demonstrate     significantly more damage to the abductors, piriformis, and short external rotators than the     direct anterior approach, which will demonstrate minimal soft tissue damage. The     investigators second hypothesis is that both surgical approaches will cause some degree of     baseline muscle damage and atrophy, in a predictable pattern. The investigators third     hypothesis is that each of the surgical approaches inherently cause some degree of soft     tissue damage, and that the periprosthetic soft tissues that are incised during the surgical     exposure will recover in a predictable pattern which is consistent but unique within each     group   "
125959|NCT01636362|"     Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total     Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of     the exclusion criteria and have given a signed and dated informed consent. Study site will be     from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the     burn is healed if that occurs earlier. All dressing changes will be performed at the clinic     and gauze rolls will be used as secondary dressing. All dressing changes will be registered     in a dressing log. All subjects will be consecutively allocated to a subject code.   "
125960|NCT01636349|"     The present study investigates the effects of recreational soccer in type 2 diabetic men in     regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6     month structured recreational soccer training and 10 men act as control with no change in     lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans,     echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting     heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12     and 24 weeks, respectively.      The study examines the hypothesis that the high-intensity aerobic work profile combined with     a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns,     sudden stops) will improve glycaemic control, muscle and cardiac function and taken together     will improve the overall health profile in type 2 diabetic men   "
125961|NCT01636336|"     The clinical studies propose to study the abuse-related effects of nicotine after     progesterone administration during the follicular phase in women of reproductive age.     Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the     role of the HPA axis in the abuse-related effects of nicotine.   "
125962|NCT01636323|"     The proposed clinical studies will evaluate the acute effects of nicotine on the     hypothalamic-pituitary-gonadal axis in women to test the hypothesis that nicotine alters     gonadal steroid hormones, and/or disrupts feedback regulation of ovarian hormones by anterior     pituitary hormones.   "
125963|NCT01636310|"     The proposed clinical studies will analyze the interactions between nicotine, alterations in     endocrine hormones, mood and cardiovascular measures. They also intend to examine the     contribution of gender and menstrual cycle phase. These studies hypothesize that this novel     focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important     for developing novel biologic approaches to treatment for nicotine abuse and dependence as     well as advancing our understanding of the neurobiology of nicotine reinforcement.   "
125964|NCT01636297|"     The purpose of this study is to gain a better understanding of how exercise training affects     motor/hand function and brain function in those diagnosed with Parkinson's disease. The     investigators want to study if exercise will improve hand function and improve the level of     brain activity.   "
125965|NCT01636284|"     This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients     with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with     sorafenib, and the safe administration of JX-594 in five weekly IV infusions.   "
125966|NCT01636271|"     The overall objective of this integrated analysis is to evaluate the clinical safety and     efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to     placebo when added to standard of care in subjects with clinical manifestations of     cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome     (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to evaluate     the effects of darapladib on the following endpoints: urgent coronary revascularization for     myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major Adverse Cardiovascular     Event (MACE), and heart failure requiring hospitalization. The first occurrent of MACE, Major     and total coronary events as well as the individual components of MACE will also be evaluated     descriptively.   "
125967|NCT01636258|"     To examine whether a lifestyle program results in weight loss and thereby delays or prevents     progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6     weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants     are randomized to receive all of the following: nutrition education, exercise instruction,     stress management instruction, and culinary education or follow usual care. Outcomes include:     blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical     activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis     of variance. Results will be used to help design larger randomized trial in the future.   "
125969|NCT01636232|"     The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in     critical condition. Especially, vitamin D level below normal prolongs hospital stay and     increases incidence of adverse prognosis and pushing up mortality of a number of diseases.     However, it is remain unclear the relationship between vitamin D levels and critically ill,     especially infection or sepsis. In this study, the investigators evaluate the significance of     vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin D's     relevance to sepsis, as well as its value in severity and prognosis assessment,     high-performance liquid chromatography and tandem mass spectrometry was used to detect the     quantification of the total 25(OH)D in serum of critically ill patients. The investigators     speculate that measurement of vitamin D could be taken as an indicator for diagnosis and     assessment in critically ill patients.   "
125970|NCT01636219|"     The major causes of morbidity and mortality in Cystic Fibrosis (CF) are linked to the process     of chronic inflammatory of the airway, leading to the progressive damage of the small     bronchioles and subsequently to the proximal bronchi. A connection between weaknesses of     respiratory muscles in CF and deficits of CFTR in the muscle has been established.     Insufficient cough in CF patients may advance re-current respiratory infections. A voluntary     cough flow volume (C-FVC) profile incorporates the characteristics of the forced expiratory     flow volume curve (FE-VC). The study aims to explore the correspondence of voluntary     cough-flow-volume and maximum expiratory flow-volume maneuvers in relation to disease     complications in CF patients.   "
125971|NCT01636206|"     The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution     compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse     events when administered BID for approximately 1 year.   "
125972|NCT01636193|"     This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect     information regarding typical symptoms of intussusceptions and bloody stool in Japan.   "
125973|NCT01636180|"     REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg)     administration in addition to high dose of clopidogrel continuous therapy (150 mg/day)     results in higher inhibition of the platelets' aggregation in patients with myocardial     infarction undergoing interventional treatment comparing to the standard therapy. Such     treatment strategy will not cause increased risk of bleeding complications. In many trials     treatment with to repeated loading doses of clopidogrel together with high dose of     clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term     therapy results, lower risk of ischemic complications. Currently, data regarding to the     results of the above treatment are still limited.   "
125974|NCT01636167|"     To construct a computerized intraoperative keratometer to analyze the axis of corneal     astigmatism accurately as well as rapidly by self-designed software during surgery.   "
125975|NCT01636154|"     The purpose of this study is to investigate the efficacy of fractions-based herbal     combinations of clearing heat and promoting blood circulation treating acute ischemic stroke     and the potential mechanism of it.   "
125976|NCT01636141|"     The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when     given as a single dose and multidose to a defined area of one knee of healthy subjects.   "
125977|NCT01636128|"     The purpose of this study is to determine the effects of 2 drugs (sulindac and     Difluoromethylornithine (DFMO)) either alone or in combination on biomarkers found in urine.   "
125978|NCT01636115|"     This study wants to understand which direction of shoulder movement and what posture of     shoulder are best for the procedure of muscle strength testing of the muscle pectoralis     major(PM). We will use muscle activity signals (sEMG) and force measurement to analyze the     contribution of two parts of PM in three different contraction direction with three different     shoulder postures.   "
125979|NCT01636102|"     To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated     influenza study vaccine, formulation 2012/2013, in adult and elderly subjects and the     antibody response to each influenza vaccine antigen, as measured by single radial hemolysis     (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult     and elderly subjects in compliance with the requirements of the current EU recommendations     for clinical trials related to yearly licensing of influenza vaccines.   "
125980|NCT01636089|"     The aim of this study is to compare bicarbonates versus saline for prevention of contrast     induced acute kidney injury in critically ill patients.   "
125981|NCT01636076|"     To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to     salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with     COPD   "
125982|NCT01636063|"     Surgical abortion in the late first trimester and early second trimester is usually performed     with the aid of a cervical preparing agent, which helps to open up the uterine cervix for the     procedure. Routine use of cervical preparants is recommended by several organizations during     this period of pregnancy before surgical abortion, especially in younger women or those who     have not delivered a baby, because their cervices may be more difficult to dilate without a     preparant.      The standard medication used for cervical preparation is misoprostol. Unfortunately,     misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who use     it. Another medication called mifepristone has been shown to dilate the cervix better than     misoprostol in the first trimester, but little information exists about using mifepristone in     the late first trimester and early second trimester.      The investigators plan to perform a prospective, double-blind, randomized trial to evaluate     if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants     who are pregnant women desiring pregnancy termination 11 to 15 weeks gestational age will be     recruited. Half will receive mifepristone and the other half misoprostol. The investigators     will measure the amount of cervical dilation achieved right before a surgical abortion to     determine if mifepristone is significantly different than misoprostol as a cervical preparant     at this stage of pregnancy. The investigators expect that mifepristone will work better than     misoprostol for this purpose.      The investigators hope to generate information about mifepristone so that women and their     health care providers can know more about mifepristone as an option for cervical preparation     before surgical abortion.   "
125983|NCT01636050|"     The purpose of this study is to determine the effects of body mass-based squat training on     body composition, muscular strength and motor fitness in adolescents.   "
125984|NCT01636037|"     Dopamine, a chemical in the brain, has been linked to schizophrenia for a number of years.     More recently, there is evidence that certain areas affected in schizophrenia (e.g.     motivation, cognition) may reflect too little dopamine, whereas symptoms like hallucinations     and delusions have been linked to too much dopamine.      This study is designed to evaluate the safety, tolerability, and efficacy of giving L-dopa     (Sinemet) to see if it will improve those symptoms related to too little dopamine. L-dopa has     been approved for other medical conditions (e.g. Parkinson's disease) and works to increase     levels of dopamine.      The investigators are linking this study with neuroimaging (fMRI) which will allows us to     link any changes the investigators might find in clinical symptoms with changes in the brain.     This information can prove useful in better understanding the mechanisms that account for     these symptoms, as well as possible new treatments.      At present , treatments for these other symptoms that seem important in functional measures     of outcome (i.e. deficit symptoms, including amotivation; cognitive symptoms) in     schizophrenia have not proven particularly effective. It is hoped that L-dopa may provide a     treatment that is more effective; going forward, this information would also be useful in     drug development and future lines of investigation.        1. L-dopa will prove effective in improving deficit (also called 'primary negative' e.g.          amotivation) and cognitive symptoms in schizophrenia.        2. It will be well tolerated and not increase risk of psychotic symptoms when administered          in conjunction with their regular antipsychotic medications.   "
125985|NCT01636024|"     The purpose of this study is to evaluate the safety profile and look at levels of AZD7594 and     biomarkers in blood when the drug is administered inhaled to healthy subjects   "
125986|NCT01636011|"     The purpose of this study is to investigate the effect of selected Osteopathic Manipulative     Medicine (OMM) techniques on the respiratory system of people with Parkinson's Disease (PD)     in comparison to light touch. Effectiveness will be measured through pulmonary function     tests, chest wall expansion, and voice analysis. Selected subjects will be randomly assigned     to one of the two groups: OMM treatment group or light touch group. Although OMM treatment     has been used on PD patients, a randomized controlled study has not been done to establish     its effect on PD respiratory function. The authors believe that this study will show OMM's     effectiveness.   "
125987|NCT01635998|"     The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in     the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom     a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF     catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.   "
125988|NCT01635985|"     The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is     administered in different ways - orally, intravenously or inhaled (with four different     devices), to healthy subjects   "
125989|NCT01635972|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of a single dose of bupropion.   "
125990|NCT01635959|"     The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease     (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms     in Egypt.   "
125991|NCT01635946|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of a single dose of atorvastatin.   "
125992|NCT01635933|"     The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared     to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .   "
125993|NCT01635920|"     The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX®     AQUA contact lenses.   "
125994|NCT01635907|"     This study is being conducted to evaluate whether the investigational drug Dovitinib, can     shrink or slow the growth of cancer in patients with certain types of neuroendocrine tumors.     This study will also further evaluate the safety of this drug.   "
125995|NCT01635894|"     The aims of the study were to attempt to answer the following questions; what proportion of     women know how to and are able to exercise their pelvic floor and for those who cannot can     they be trained and motivated to do so. This was a nested design comprising a prospective     cohort study together with a controlled trial intervention after baseline assessment in the     cohort study for a defined at-risk group.   "
125996|NCT01635881|"     To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA     dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary     arteries or bypass grafts.   "
125997|NCT01635868|"     Background Mesh repair reduces the risk of reoperation for recurrence in patients with small     umbilical and epigastric hernias compared with sutured repair. However, reoperation for     recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement     may induce chronic pain. This study investigated the cumulated risk of recurrence after open     mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk     factors were evaluated for chronic pain and recurrence.      Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary,     elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were     included. Follow-up was performed by a validated questionnaire regarding suspicion of     recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical     examination. Recurrence was defined as reoperation for recurrence or clinical recurrence.     Risk factors for recurrence and chronic pain were investigated by multivariate analyses.      Results      1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and     follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate     55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair     (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured     repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain     (P<0.001).      Conclusion Mesh repair halved the long-term risk of recurrence after repair for small     umbilical and epigastric hernias without increased risk of chronic pain.   "
125998|NCT01635855|"     A prospective, open-label 1-month post-approval study to evaluate the short term safety of     Belotero® Balance in the re-treatment of nasolabial folds.   "
126001|NCT01635816|"     The proposed Japanese Encephalitis (JE)Vaccine study is a four-arm double-blind randomized     controlled single center trial to evaluate, by examining post-vaccination seroprotection     titers, the lot-to-lot consistency of three lots of JE live attenuated SA 14-14-2 vaccine     manufactured in a new GMP facility, and to establish non-inferiority of the new vaccine in     comparison to a single lot of the same vaccine manufactured in the existing facility. The     study will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to     providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA     14-14-2 vaccine among Bangladeshi children. This will be the first step to secure licensure     for this life-saving vaccine in Bangladesh as well as provide data to support WHO     prequalification of JE live attenuated SA 14-14-2 vaccine.   "
126002|NCT01635803|"     The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment     of patients with macular edema secondary to a retinal vein occlusion (branch or central) as     determined by the change in best-corrected visual acuity in the study eye from baseline to     month 6.   "
126003|NCT01635790|"     The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in     the treatment of patients with DME (OCT central area thickness > 275 μm) as determined by the     change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.   "
126004|NCT01635777|"     Miltefosine efficacy will be >85%   "
126005|NCT01635764|"     Hidradenitis Suppurativa is a painful, chronic skin disease characterized by recurrent     inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring.     This Study is an open-label extension study available to subjects who participated in a prior     adalimumab study who meet all the inclusion and none of the exclusion criteria. The purpose     of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in     subjects with moderate to severe HS.   "
126006|NCT01635751|"     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.      GLA5PR GLARS tablet 150mg is a new once-a-day formulation which is made by GL Pharm Tech     corporation.      GLARS(Geometrically Long Absorption Regulated System) is new solution to sustained absorption     by extending the absorption Site.      To overcome the shortcomings of the currently existing sustained release drug delivery     technologies the investigators have recently developed a novel drug delivery system to enable     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).   "
126007|NCT01635738|"     Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant     treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus     paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei     GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant     treatment of atopic dermatitis and asthma.   "
126008|NCT01635725|"     The purpose of this investigation is validate a new bowel preparation scale and to compare it     to existing bowel preparation scales.   "
126009|NCT01635712|"     Hsp90 is a chemical in the body that is involved int he promotion of cancer. SNX-5422 is an     experimental drug that blocks Hsp90.   "
126010|NCT01635699|"     The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty     (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS- on     oxidative damage.   "
126011|NCT01635686|"     The purpose of this study was to compare the safety and pharmacokinetic characteristics of     DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male     volunteers.   "
126012|NCT01635673|"     The purpose of this study is to determine if whole body vibration exercise improves     insulin/glucose dynamics and bone metabolism in Latino Boys.   "
126013|NCT01635660|"     This research project examines the effectiveness of different video laryngoscopes in a     out-of-hospital emergency intubation. Since in preclinical airway management severe incidents     with esophageal failures of intubation may partly happen or rather endotracheal Intubation     may completely fail, it is of great importance to evaluate alternative ways of endotracheal     intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in     everyday clinical practice and may clinically be superior in most situations when compared to     endotracheal Intubation using a conventional laryngoscope. No data exist, if different video     laryngoscope types perform differently in the out-of-hospital setting. The investigators     hypothesize that there would be no difference with regard to intubation time, intubation     success, and intubation morbidity between different models of video laryngoscopes.   "
126014|NCT01635647|"     Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows     efficacy against malaria infection when tested in UK volunteers using sporozoite challenge     experiments. It is a leading candidate vaccination strategy against malaria. In the field,     Phase I studies have been conducted in adults in Kenya and The Gambia and children and     infants in The Gambia. The vaccination strategy appears safe and well tolerated in these     populations, and also shows impressive immunogenicity, not significantly different to that     seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia     shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be     the ones to benefit most from such a vaccine against malaria. With this clinical development     as background, the investigators now propose to evaluate efficacy against natural malaria     infection in this important target group for an effective malaria vaccine, that is, 5-17     month infants and children living in malaria endemic areas. The proposed study area, Banfora,     Burkina Faso, is highly endemic for Plasmodium falciparum malaria.   "
126015|NCT01635634|"     The purpose of this randomized controlled study is to determine the effectiveness of cupping     in patients with fibromyalgia compared to sham cupping.   "
126016|NCT01635621|"     The primary purpose of this multi-centre, double blind-study is to evaluate the clinical     response of patients with moderate to severe Cohn's Disease (CD) following treatment with     different doses and dose regimens of Olokizumab, relative to placebo.   "
126028|NCT01635465|"     Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a     recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine     plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study     with small sample.   "
126017|NCT01635608|"     To visualize the localization and to measure the volume of water in the small intestine by     T2-weighted MRI imaging after oral administration of 240 ml water (non-caloric water) and     after administration of 240 ml water containing 25.5 g sucrose (105 kcal, caloric water).      To measure pharmacokinetics of the probe-drugs paracetamol, talinolol and amoxicillin after     oral administration dissolved in 240 ml non-caloric and in 240 ml caloric water.   "
126018|NCT01635595|"     Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors     according to the TNM 7th ed., however controversy is pending on the unique or dual     pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological     patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM)     and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic     spreading may differ according to the type of tumor. The investigators retrospectively     investigated the pathways of lymphatic spreading in 194 consecutive patients who received     radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.   "
126019|NCT01635582|"     The purpose of the study is to determine whether a novel computer gaming hand exercise     regimen would improve hand function, decrease pain/ stiffness and be feasible in people with     Rheumatoid arthritis or Osteoarthritis affecting the hands.   "
126020|NCT01635569|"     Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric illness beginning in     childhood. Effective OCD treatments include cognitive-behaviour therapy (CBT) and medications     but access to treatment is difficult and does not systematically include parents. The     investigators will evaluate clinical and neural effects of Group-based Family CBT (GF-CBT),     via a case-control study including: Group 1 - OCD cases receiving GF-CBT (N=90); Group 2 -     OCD waitlist cases (N=90). Effects will be measured between baseline and completion of 12     GF-CBT sessions: comparing OCD severity and functioning changes between Groups 1 and 2.   "
126021|NCT01635556|"     The goal of this pilot project is to offer outpatient Dialectical Behavior Therapy (DBT)     treatment as described in Linehan's text (1993), which is considered an effective treatment     of borderline personality disorder. This treatment consists of weekly individual     psychotherapy, weekly group skills training, 24 hour telephone consultation, and weekly team     consultation meetings for therapists. The investigators program is able to offer all of these     components except the 24 hour phone consultation (which has been modified due to     employment/union guidelines of interdisciplinary staff working within the investigators     health care system). This project intends to offer the treatment for a period of 6 months.      As such, this proposed research project seeks to assess the feasibility of implementing an     outpatient DBT program within a public health care setting in Canada. This study also aims to     evaluate this DBT program for clinical effectiveness in its modified format. Specifically,     the investigators will examine relevant outcomes related to patient functioning (e.g.,     depression, self-harm and suicidal behaviors, and admissions to hospital/ER visits) and     improvement (e.g., improved quality of life, meeting work/employment goals) pre and post     completion of this 6 month treatment program.      The investigators hypotheses are that each patient will show improvement in all outcome     variables (e.g., improved mood and quality of life, decreased self-harm, decreased ER visits     and hospitalization visits, etc). The investigators also hypothesize that the investigators     modified program will produce comparable results to those from studies of standard outpatient     DBT.   "
126022|NCT01635543|"     Objective:      The aim of this study is to investigate whether Crohn's Disease patients with peri-anal     fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's     Disease patients that would benefit from sexual health interventions.      Hypothesis:      Crohn's patients with active perianal fistulas will have decreased sexual drive, performance,     and satisfaction than those with Crohn's Disease in remission.   "
126023|NCT01635530|"     The main purpose of this study is to determine whether four weeks treatment with oral     doxycycline is as effective as three weeks treatment with intravenous ceftriaxone in patients     with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme     neuroborreliosis and further define the manifestations and epidemiology of the disease in     Finland.   "
126025|NCT01635504|"     Altered contour of the lower face is a frequent complication of human immunodeficiency virus     (HIV). HIV facial lipoatrophy or loss of facial fat commonly results from antiretroviral     therapy. Posterior cheek enlargement leading to a bulky and widened lower facial contour can     also be seen in HIV. These changes can lead to significant cosmetic disfigurement and have an     enormous psychosocial impact on patients. They also make individuals vulnerable by making     them recognizable as persons living with HIV. Posterior cheek enlargement has not been well     characterized. Both the parotid salivary gland and the masseter muscle are located in the     posterior cheek region. Although parotid gland enlargement in a common complication of HIV,     it is unknown whether enlargement of the masseter muscle also contributes. The investigators     plan to study posterior cheek enlargement in HIV positive individuals. The investigators also     plan to use botulinum toxin A as a novel treatment to improve the altered lower facial     contour seen in HIV. This treatment has already demonstrated efficacy in HIV negative     individuals with enlargement of the masseter muscle. Botulinum toxin has also been used     safely in the salivary glands in individuals with excessive drooling resulting from     neurological disease. In a trial HIV+ patient, the investigators have already demonstrated     the efficacy of using botulinum toxin A in the treatment of posterior cheek enlargement,     resulting from both parotid and masseter muscle enlargement. The investigators anticipate     this study will increase our understanding of posterior cheek enlargement in HIV and lead to     the development of a novel treatment for this important complication.      The investigators hypothesize that posterior cheek enlargement in HIV+ patients will in some     cases result from both masseter muscle hypertrophy as well as parotid gland enlargement. The     investigators also hypothesize that the treatment of posterior cheek enlargement with     botulinum toxin A will result in a more aesthetically appealing lower facial contour in HIV+     patients. This has already been demonstrated in a trial HIV+ patient, in which there was a     dramatic change in the volume of the masseter muscle and parotid gland 12 weeks after     treatment with botulinum toxin A.   "
126026|NCT01635491|"     The purpose of this study is to describe gastrointestinal motility and transit times in     healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal     transit time (GITT) to GITT obtained using radioopaque markers.      The investigators end points are to measure the transit times through different segments of     the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.      The study is descriptive and is designed to test and evaluate the usefulness of the Motilis     3D-Transit system. The investigators hypothesize, that with the system transit times through     different segments of the gastrointestinal canal can be measured.      The design is made for evaluating the transit times, the inter-subject reproducibility and     comparison with gold standard for colonic transit time measurement.      The investigators have chosen to include 20 healthy volunteers.The study is descriptive and     therefore power calculation is not needed.   "
126027|NCT01635478|"     EMERGENCY CANCER PAIN MANAGEMENT HAS BEEN INCONSISTENT AND INADEQUATE ACROSS THE GLOBE. THIS     STUDY AIMS TO KNOW EMERGENCY ROOM CANCER PAIN PATTERNS AND TREATMENT ADEQUACY IN TERTIARY     CARE CANCER HOSPITALS.   "
126031|NCT01635426|"     The study will compare the effect of Aspirin versus clopidogrel effect on uterine perfusion     in women with unexplained recurrent pregnancy loss with decreased uterine artery pulsatility     index.      Null hypothesis: Women with recurrent miscarriage have the same blood flow after aspirin or     clopidogrel treatment compared to their uterine artery pulsatility index before treatment.   "
126032|NCT01635413|"     This research is being done to compare the physical and quality of life benefits of two     different types of exercise- tai chi versus strength training- for female cancer survivors     who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to     participants in a group that performs flexibility and relaxation exercises, which is expected     to have different benefits than either tai chi or strength training.   "
126033|NCT01635400|"     The purpose of this study is to find out the correlation between uridine diphosphate     glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of     irinotecan in patients with small cell lung cancer.   "
126034|NCT01635387|"     Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study     was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor     improves mortality and cardiovascular outcomes in these high-risk population.   "
126035|NCT01635374|"     Achalasia is an esophageal motility disease that usually requires surgical intervention     (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with     myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new     NOTES based procedure, per-oral endoscopic esophagomyotomy (POEM), has been developed that     eliminates the need for skin incisions. All patients enrolled in this study, will have a     thorough pre-op workup (including upper endoscopy, upper GI radiographs, high resolution     esophageal manometry) confirming the diagnosis of achalasis at the Northwestern Esophageal     Center. In this procedure, performed in the operating room under general anesthesia, a     flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is     created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower     esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the     mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed     with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin     esophagram will be performed on post-op day 1 to rule out esophageal leak. All patient will     have a 2-3 week post-op appointment      Patients with a confirmed diagnosis of achalasia may be offered POEM. The investigators     hypothesize that POEM is feasible and safe and can effectively reduce residual LES pressure     (as determined by manometry) and improve patients symptoms and quality of life.   "
126048|NCT01635205|"     This study examines randomized triple-blind clinical trial and the efficacy of paraspinous     anesthetic block on the treatment of chronic pelvic pain in patients non-responsive to     pharmacological management. Sixty patients will be randomly divided and allocated into group     intervention (paraspinous anesthetic block) and control (placebo procedure in subcutaneous     tissue).   "
126166|NCT01633658|"     The investigators hypothesize that native vitamin D will have more variability in 25(OH)D     dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be     a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500     μg native vitamin D given orally.   "
126036|NCT01635361|"     About 25% medicines prescribed for long term conditions are not taken as directed, and     approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine     Service (NMS) is a community pharmacy service that started in England in October 2011 which     involves the pharmacist providing additional support to patients starting a new medicine for     some breathing problems (asthma & COPD), high blood pressure, adult onset diabetes or     medicines which reduce blood clotting. It aims to improve the way patients take their     medicines improving outcomes and reducing costs to the National Health Service (NHS).      The investigators will assess the effectiveness and cost effectiveness of the NMS using a     research study where some people will receive the NMS, and some won't, so The investigators     can look at the effect of the NMS on problems with their medicines, medicines taking and use     of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and     London areas.      The investigators will recruit 500 patients from a range of different pharmacies and follow     them up at six, ten and twenty six weeks after starting their new medicine to assess effects     on medicines taking behaviour, patients' reported problems with medicines, referrals to their     General Practitioner (GP) and use of NHS resources. The investigators will compare the data     gathered from this study with that being collected routinely by all pharmacies in England to     provide wider estimates of cost effectiveness.      The investigators will also explore how the NMS service is being implemented by pharmacies. A     sample of patients from the main study will be followed in more detail. This will involve     recording the consultations with the pharmacist and also interviewing patients about their     experience of the service. The investigators will interview the patients GP to investigate     their views of the service. The investigators will also try to understand why people decline     the invitation for the NMS   "
126037|NCT01635348|"     The purpose of this research study is to compare two different exercise treatments for     walking problems in older adults. The investigators want to determine if participation in the     exercise programs will improve walking and thinking abilities.   "
126038|NCT01635335|"     The proposed project will test an HIV prevention intervention for Latino parent-adolescents     dyads. This randomized controlled trial will:        1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV          prevention intervention or a family-based General Health Promotion condition.        2. Determine the efficacy of the Latino Family-based HIV prevention intervention from          assessment of changes in HIV-related sexual behavior and attitudes over 18 months among          a sample of 320 Latino parent-adolescent dyads.        3. Determine the efficacy of the Latino Family-based HIV prevention intervention from          assessment of changes in family relationships and parental monitoring/supervision over          18 months among a sample of 320 Latino parent-adolescent dyads.        4. Examine the association of other important constructs, such as religiosity,          acculturation, cultural values, and sexual socialization with the primary outcomes.      Based on a thorough review of the literature and preliminary data from a recent, small pilot     study, the investigators hypotheses are:        1. Compared to the General Health Promotion Control condition, the Family-Based HIV          Prevention intervention will result in greater change with regard to primary outcome          measures of safer sexual behavior (recent sexual activity, the number of unprotected sex          acts, and intentions to use condoms) and safer HIV-related attitudes.        2. Compared to the General Health Promotion Control condition, the Family-Based HIV          Prevention intervention will result in greater change with regard to family          relationships and parental monitoring/supervision through improved parent-child          communication skills and they will mediate the intervention impact.        3. Religiosity, acculturation, cultural values, and sexual socialization will have          meaningful associations with the primary outcomes and will act as moderators of          intervention impact.   "
126039|NCT01635322|"     The purpose of this study is to evaluate the correlation between the restoration of the     sagittal balance and the improvement of the Quality of Life for patients with adult     scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a     spinal fusion surgery.   "
126053|NCT01635140|"     Hypofractionated radiotherapy reduce the patient and family burden through decreasing the     overall treatment time. This study is to evaluate the clinical end results of the     hypofractionated radiotherapy in DIPG compared to the conventional treatment. The     non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital,     stay or engagement, for more than its half with the same results.   "
126054|NCT01635127|"     Evaluation whether canakinumab leads to improvement of urticaria   "
126040|NCT01635309|"     Worldwide 200 million adults annually undergo major noncardiac surgery and 5 million of these     patients will suffer a major vascular complication. Despite the magnitude of this problem our     capacity to predict these events is limited. Although perioperative myocardial infarction     (MI) is the most common major perioperative cardiac complication, little is known about its     pathophysiology. Coronary computed tomography angiography (CTA) is a potential non-invasive     method for the detection of coronary artery disease and cardiac risk stratification in the     non-operative setting; however, the value of this test to enhance risk prediction among     patients scheduled for noncardiac surgery is unknown. This study is an international     prospective cohort study to determine among patients with, or at risk of, atherosclerotic     disease who are undergoing noncardiac surgery: 1) if preoperative coronary CTA has additional     predictive value for the occurrence of major perioperative cardiac events and 2) the     underlying coronary anatomy associated with perioperative MIs.   "
126041|NCT01635296|"     This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and     efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous     leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard     induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2     subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who     have relapsed or are refractory after at least one cytarabine/anthracycline containing     regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2     intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of     therapy, patients in Arm A who achieve hematologic response may continue additional cycles     until disease progression.   "
126042|NCT01635283|"     The primary purpose of this phase II clinical trial is to determine the safety and effect on     survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a     treatment for low-grade glioma patients. Other goals of this study are to determine if the     vaccine can cause an immune response against patients' cancer cells and slow the growth of     their brain tumors   "
126043|NCT01635270|"     The purpose of this study is to establish on the market and to clinically evaluate a new     strategy of treatment for patients with locally advanced non-small cell lung cancer using     deformable repositioning of 4D imaging.   "
126044|NCT01635257|"     Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high     D-dimer level should undergo a second level diagnostic test such as Multidetector Computed     Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is     expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is     safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic     role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT),     TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or     Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No     previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined     (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of     multiorgan US.      Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical     suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value     ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE     diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA.     PE was considered echographically present if CUS was positive for DVT or TTE was positive for     RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the     single and multiorgan US was calculated.   "
126062|NCT01635023|"     Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.   "
126188|NCT01633372|"     This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will     evaluate safety and efficacy parameters of itacitinib (INCB039110).   "
126049|NCT01635192|"     Probiotics have become very popular and are by WHO defined as Live microorganisms which when     administered in adequate amounts confer a health benefit on the host. For example,     probiotics have been shown to contribute to improvements of abdominal discomfort and     intestinal inflammation. The main hypothesis behind the present study is that probiotics     influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II     locally in the intestinal mucosa.   "
126050|NCT01635179|"     To prevent bronchial aspiration during induction of anaesthesia it has been a common     procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and     thereby prevent aspiration. During the last ten years the efficiency of this maneuver has     been discussed, since it probably prolong the intubation time and do not significantly     reduces the risk of aspiration.      The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view     of the laryngeal inlet, during intubation with a videolaryngoscopy.      The hypothesis is tested by a double-blinded randomized study where patients is intubated     twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid     pressure is blinded to the personal performing the intubation.   "
126051|NCT01635166|"     The purpose of this study is to monitor the performance of the DeltaMotion cup system in the     treatment of patients with hip joint disease requiring a total hip replacement.Patients who     enter the study will be evaluated at regular intervals following hip surgery using patient,     clinical and x-ray assessments.   "
126052|NCT01635153|"     The objective of this randomized, controlled trial is to determine if adding a     protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV     will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly     diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the     investigators will conduct dietary interviews, measure body composition, randomize subjects     to receive a PCS (plus micronutritional supplements [MNS]) or control (MNS only) for the     6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects     will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months     (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug     continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on     Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint     will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months     after completion of ATT).   "
126055|NCT01635114|"     The purpose of this study is to investigate the effects of the antioxidant resveratrol on     liver fat content, body-composition and insulin sensitivity      Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have     health benefits such as improving fat metabolism, insulin action, and possibly extending     lifespan. resVida™ is the name for the dietary supplement containing the natural antioxidant     resveratrol. resVida™ will be supplied by DSM Nutritional Products, Ltd.      resVida™ is considered a dietary supplement, and therefore it is not an approved drug by     German Authority. It is regulated like a food. The makers of resVida™ make no claim that this     supplement is meant to treat any ailment.      This study is designed to investigate the health benefits of resveratrol.   "
126056|NCT01635101|"     The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV)     acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates     and infants (age < 2 years) compared to placebo plus standard of care rescue opioids as well     as characterize the concentration-effect relationship (PK/PD) of the intravenous     acetaminophen as compared to the control group.   "
126057|NCT01635088|"     Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects     in chronic asthma. However, they also have largely unappreciated early effects when initiated     as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such     an early effect better than spirometry. The investigators sought to examine the onset of     action and sustained effects over 4 weeks treatment of mometasone furoate as measured by     Impulse Oscillometry System (IOS) versus spirometry.   "
126058|NCT01635075|"     People with schizophrenia have two- to three-times the mortality risk of the general     population. This is primarily due to their unusually high rates of cigarette smoking, as well     as other cardiovascular risk factors such as physical inactivity, obesity, high blood     cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and     mortality in this population. Over a dozen experimental studies indicate that walking and     other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and     smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on     smoking measures have not been studied in smokers with schizophrenia. This study will use a     within-subjects, repeated-measures design, in which participants will undergo 4 laboratory     sessions (order counterbalanced across participants): (1) smoking cues followed by exercise,     (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4)     neutral cues followed by passive activity. Outcome measures include cigarette craving,     nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study     indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the     next step in this research would be to test the effectiveness of a smoking cessation     intervention that incorporates exercise bouts as a behavioral strategy for improving smoking     cessation rates in this population.   "
126059|NCT01635062|"     The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers     renin-angiotensin system activity.   "
126060|NCT01635049|"     The purpose of this research study protocol is to collect imaging data on embryos followed to     blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome     screening (CCS) results, implantation and live birth.   "
126061|NCT01635036|"     The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva     12-well Dish.   "
126063|NCT01635010|"     Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase     cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled     clinical studies investigating the independent effects of OSA in the development of     cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders     such as inflammatory response, oxidative stress and vascular changes. The investigators     hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular     consequences in OSA patients would be less important.      The purpose of this study is to analyze the effects of OSA in the absence of MS, on     inflammatory, oxidative stress and vascular markers; to verify the influence of excessive     daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal     continuous positive airway pressure (nCPAP)in theses parameters.   "
126064|NCT01634997|"     The primary objective is to identify compare SCOUT DS to random capillary glucose for     identification of at-risk subjects with dysglycemia defined by hemoglobin A1c ≥ 6.0%.   "
126065|NCT01634984|"     Selected 400 cases of women with primary breast cancer who were treated with operation     randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly     selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect     the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.   "
126066|NCT01634971|"     Postoperative pancreatic fistula (POPF) and other surgical complications are common after     pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct     is important and a stent is usually placed in the operation, but it is still controversial     whether the stent drainage is internal or external.   "
126067|NCT01634958|"     Specific immunotherapy for IgE mediated sensitization to grass pollen      4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the     optimum dose.   "
126068|NCT01634945|"     The proposed project is aimed at testing two interventions, namely a highly bioavailable iron     compound and a combination of SP plus amodiaquine for intermittent preventive treatment (IPT)     of malaria, to reduce anaemia in very young children.   "
126078|NCT01634815|"     Evaluation of a new biological criterion, the local capillary blood lactates to optimize the     management of patients with chronic critical ischemia requiring revascularization fast.     Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent     ischemia in a limb revascularized.   "
126079|NCT01634802|"     The purpose of this study is to determine whether the use of a Computerized Decision Support     System (CDSS) in form of alerts to clinicians enhances early detection of immunological     treatment failure in HIV patients.   "
126080|NCT01634789|"     The purpose of this study is to evaluate 3 test formulations relative to a reference     formulation.   "
127837|NCT01611779|"     The objective of this study is to assess the feasibility and safety of tongue suspension     using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive     sleep apnea (OSA).   "
126069|NCT01634932|"     Iron deficiency (ID) with or without anemia is still a main public health problem in     sub-Saharan Africa and Southern Asia, especially in vulnerable population groups such as     children below 5 years of age and women of reproductive age. The etiology of ID is     multifactorial; but major causes are low iron dietary bioavailability and intake from     monotonous cereal-based diets aggravated by chronic parasitic infections such as malaria and     soil-transmitted helminthes. Approaches such as dietary diversification, supplementation with     pharmacological iron doses, public health measures (e.g. deworming, malaria control) and food     fortification with different iron compounds have notably reduced morbidity and mortality     caused by ID but have not been universally successful. Biofortification is a new promising     approach to combat micronutrient deficiencies such as ID. It is defined as the process of     increasing the content and bioavailability of essential nutrients such as iron in crops by     traditional plant breeding and/or genetic engineering. Pearl millet is a staple food for many     people living in different areas of West Africa (e.g. Northern Benin) and India, two parts of     the world, where ID is still widely prevalent. Therefore, pearl millet was one of the crops     targeted for iron biofortification by HarvestPlus.      To improve human iron status successfully, the additional iron gained through     biofortification has to be at least as bioavailable as the iron in regular peal millet     varieties. For that reason we are planning an iron absorption study where we will investigate     the iron bioavailability from an iron-biofortified millet variety and compare it with the     iron bioavailability from a regular-iron millet variety and from regular-iron millet     fortified post-harvest with ferrous sulfate (FeSO4). Iron absorption will be determined by     incorporation of labeled iron into erythrocytes, at least 14 days after the administration of     the test meals containing labeled iron (stable isotope technique). The three different test     meals based on 1) regular-iron, 2) iron-biofortified and 3) post-harvest iron-fortified     millet will be administered as multiple meals i.e. each study participant will consume each     test meal for a period of 5 days (2 portions/day; one in the morning, one for lunch). Twenty     apparently healthy Beninese women with a low/marginal iron status (serum ferritin < 25 ;g/L),     non-anemic or mildly anemic (hemoglobin >90 g/L), 18-30 years of age with a body weight < 65     kg and normal body mass index will be included in the study.      The results of the study will provide important insights on the iron bioavailability from     regular, biofortified and post-harvest fortified staple crops such as pearl millet when     feeding multiple meals as part of a more complex diet. The results can be applied to     different meals based on pearl millet such as the West African millet pastes or the Indian     flat breads.   "
126070|NCT01634919|"     •The purpose of this study is to compare the performance between liver biopsy and     non-invasive fibrosis assessments evaluating anti-fibrotic efficacy of peginterferon plus     ribavirin in patients with hepatitis C pre- and post-treatment   "
126071|NCT01634906|"     Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB)     may be protective against atherosclerosis. However, statins may have an effect on ery-apoB.      Objective: to investigate the effect of statins on ery-apoB levels.      Study design: a non-randomized intervention study. Ery-apoB will be measured twice in     volunteers who are on statin therapy for medical reasons. After a baseline measurement of     ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a     second measurement of ery-apoB. Consecutively subjects will start with their original statin     therapy again.      Study population: patients on statin therapy aged 18 years or older.      Intervention: temporary discontinuation of statin therapy for a period of six weeks.      Main study endpoints: changes in ery-apoB levels.      Risks, burden and benefits on participation: volunteers will visit the outpatient clinic     twice, the second visit will be exactly six weeks after the first visit. The volunteers'     general practitioner and medical specialist (internist or cardiologist) will be informed     about their participation. Subjects have to fast for 10 hours before every visit and venous     blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will     discontinue their usual statin therapy for a period of six weeks. No major risks are involved     with temporary discontinuation of statin therapy in stable chronic cardiovascular disease.     Volunteers will receive 25 euro's in total for participation. Participation serves to further     investigate the relation of statins and potentially beneficial binding of apoB on     erythrocytes.   "
126072|NCT01634893|"     Patients with recurrent, refractory or metastatic solid tumors have a dismal prognosis with     few viable treatment options. Hydroxychloroquine (HCQ) is an agent that has been widely used     to treat malaria. Because HCQ also inhibits autophagy, a process central to survival of     cancer in the face of metabolic stress, including the effects of anti-cancer therapy, it is     now in human cancer trials combined with other agents to attempt to boost the efficacy of     those agents. Autophagy inhibition improves the activity of sorafenib in hepatocellular     carcinoma.      Sorafenib is an oral multi-kinase inhibitor that blocks not only receptor tyrosine kinases     such as KIT, VEGFR and PDGFR but also serine/threonine kinases along the RAS/RAF/MEK/ERK     pathway.      The investigators propose to treat patients with refractory or relapsed solid tumors with     sorafenib, to boost its efficacy while attempting to mitigate its toxicity by combining with     HCQ.   "
126073|NCT01634880|"     Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery     followed by postoperative radiation therapy. Studies have shown the superiority of combined     modality therapy compared to surgery alone. Despite the addition of postoperative radiation     therapy, the five-year survival for locally advanced salivary gland malignancies is poor     (less than 60%). In salivary gland malignancies, the epidermal growth factor receptor (EGFR)     is expressed in 25-85%; in certain histological types, like salivary duct carcinomas, the     expression is higher. EGFR is a promising target of anticancer therapy. In squamous cell     carcinoma of the head and neck, a phase III trial utilizing cetuximab added to radiation     therapy improved both locoregional control and overall survival compared to radiation alone.     Panitumumab is a novel, human, IgG2 EGFR monoclonal antibody that may be better tolerated and     more efficacious than cetuximab. Here, the investigators hypothesize that the addition of     panitumumab to standard radiotherapy in locally advanced salivary gland malignancies will     improve recurrence-free survival (RFS).   "
126074|NCT01634867|"     This study will evaluate using intraosseous vascular access and intravenous vascular access     to give pediatric patients the necessary medications to perform rapid sequence intubation,     for patients with airway difficulties.   "
126075|NCT01634854|"     This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous     oxytocin (Pitocin) in multiparous women who present at term for labor induction.   "
126076|NCT01634841|"     This will be a systematic investigation of the role of walnuts in preventing or slowing age     related cognitive decline and age related macular degeneration. 700 subjects will be     recruited between 2 sites, Loma Linda University in California, USA and Hospital Clinic in     Barcelona, Spain. Participants will be randomly assigned to either the walnut group or the     control group for a 2 year intervention. Baseline and annual data will be collected and     analyzed.   "
126077|NCT01634828|"     The purpose of this study is to develop a mathematical algorithm which the investigators plan     to use to more accurately estimate intraoperative blood loss.   "
126092|NCT01634633|"     The aim of this study is to investigate the prevelence of endometrial nerve fibers in     different gynecological pathologies   "
126081|NCT01634776|"     Fatty acids or omega-3s are important in the human diet for brain development. Of the three     main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3;     docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been     shown to be important in brain function. Conversely, little is known about the effects of ALA     even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA     and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in     the human diet, ALA is more readily available, more easily consumed, and less expensive     relative to animal sources of DHA and EPA. So, it is very important that the investigators     explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA     conversion rate can be altered by methylation, an epigenetic form of gene expression and     regulation. In the present study, the investigators will examine memory abilities and genetic     baselines in 16-month-olds. The investigators will then supplement their food with ALA or     control oil for 4 months. At 20 months, the investigators will collect outcome data on     memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize     that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA     conversion through methylation and genetic variations and subsequently, memory abilities will     improve. The data from this study will be used to design a larger R01 grant.   "
126082|NCT01634763|"     Estimation of the Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378 as a     single agent when administered orally to Japanese patients with tumors characterized by     genetic alterations in anaplastic lymphoma kinase (ALK)   "
126083|NCT01634750|"     Background:      - Hereditary inclusion body myopathy (HIBM) is a genetic disorder caused by mutations in a     gene called GNE. This gene is responsible for producing a sugar called sialic acid. Low     levels of sialic acid may cause muscle problems. Symptoms of HIBM include walking     difficulties and muscle weakness, which usually start in a person s 20s or 30s and become     worse over time.      Researchers are studying a drug called ManNAc. It may be useful for treating HIBM. However,     this drug is still being tested. Researchers want to see how ManNAc is absorbed into and     removed from the blood. They will not be looking specifically at whether ManNAc can stop or     slow the symptoms of HIBM.      Objectives:        -  <TAB>To study how MaNAc is absorbed into and removed from the blood in people with HIBM.        -  <TAB>To study of safety of ManNAc in people with HIBM.      Eligibility:      - Individuals between 18 and 70 years of age who have HIBM.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have a 3 to 4-day inpatient stay for the main part of the study.        -  Participants will be divided into groups of six. In each group, four will take ManNAc          and two will take a placebo. Participants will not know which one they will receive.        -  Participants will have a single dose of either ManNAc or placebo. They will be monitored          for any possible side effects. Frequent blood samples will be collected during the 4-day          stay.        -  No treatment for HIBM will be provided as part of this study.   "
126084|NCT01634737|"     This study evaluates the diagnostic efficacy of CAP System (capsulated hydrophilic carrier     polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects     allergic to shrimp with CAP positive subjects allergic to mites, crustaceans asymptomatic but     with a positive CAP to shrimp, to identify those at greatest risk of food reactions.   "
126085|NCT01634724|"     To test whether GnRHa withheld 2-3 days before ovulation trigger reduces the incidence of     ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic     ovaries (PCOs) who have been treated with gonadotropins for in vitro fertilization (IVF) or     Intracytoplasmic sperm injection (ICSI).   "
126086|NCT01634711|"     The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft     Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior cruciate     ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will     participate in this study. The hypothesis of this study is that the L-C Ligament will     successfully regenerate the ACL with clinical outcomes similar to or better than surgical     intervention with auto graft tissue.   "
126087|NCT01634698|"     The relative-dose-response test (RDR) is considered to be the most accurate method for     evaluating vitamin A nutritional status (VANS) in patients suffering from liver disease, as     it infers the reserves of the vitamin in the liver. However, for the RDR test to reflect VANS     in patients suffering from chronic liver disease, factors inherent to the disease need to be     considered, such as possible malabsorption, advanced age, a drop in synthesis and/or the     release of retinol binding protein (RBP), which would result in an inadequate response to the     RDR test. Thus, the objective of present study is to assess the adequacy of two different     protocol for using the RDR test in patients with cirrhosis and cirrhosis-related     hepatocellular carcinoma.      Methods: The sample group was comprised of 178 patients at Federal University of Rio de     Janeiro University Hospital (111 men) with several etiologies of liver cirrhosis at different     stages in the progression of the disease. They were sorted into two groups, according to the     retinyl palmitate dosage (1500 IU or 2500 IU) received at T0 (blood sample taken following a     12-hour fast). Following supplementation, the investigators took further blood samples five     and seven hours later (T5 and T7). The investigators assessed VANS via concentrations of     serum retinol and RBP, as well as by way of the RDR test. The cutoff points the investigators     used for denoting inadequacy in the indicators retinol and RDR were, respectively, < 1.05     µmol/L and ≥ 20%. To classify the degrees of severity of the disease the investigators used     the criteria established by Child & Pugh (1973).   "
126088|NCT01634685|"     This is a phase I study incorporating bavituximab into the care of patients with rectal     adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no     reference therapy as we are trying to identify the MTD of bavituximab in this combination.   "
126089|NCT01634672|"     The purpose of this study is to determine the prevalence of GERD among chronic kidney disease     with peritoneal dialysis and hemodialysis in Korea.   "
126090|NCT01634659|"     The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily     disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.   "
126091|NCT01634646|"     This observational placebo-controlled pilot study is intended to document whether or not     Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively     impact, (a) weight and, (b) cholesterol levels in man.   "
126093|NCT01634620|"     Objective: To characterize FeNO levels that may be indicative of eosinophilic airway     inflammation in patients with chronic obstructive airways disease      Number of participants: Approximately 200 subjects will be enrolled      Reference product: NIOX MINO® Instrument (09-1100)      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be     performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO®     User Manual      Safety assessments: The Investigator is responsible for the detection, reporting, and     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious     Injuries as provided in this clinical investigation plan from the time that informed consent     has been provided and during the study period      Criteria for evaluations: This is an observational, pilot study and there are currently no     plans for a formal statistical analysis. Information gained from this study may used to     design subsequent studies in patients with chronic obstructive airways disease. Information     collected will be summarized in a clinical study report but will not be subject to formal     hypothesis testing   "
126094|NCT01634607|"     This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as     well as effects of TDF on the patients' bone among HIV positive and negative patients.   "
126095|NCT01634594|"     Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or     the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that     have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several     different regimens are used to lower the patient's blood pressure, such as vasodilators,     autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects     that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not     known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e     intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of     anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect     that these agents may have on the QTc and Tp-e intervals may not be negligible. The     investigators of the present study found that the high dose of commonly used hypotensive     agents tend to prolong these variabilities to some extent. This study will be able to provide     insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e     intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate     hypotensive anesthesia.   "
126096|NCT01634568|"     A double-blind, randomised, placebo-controlled study of the safety, tolerability and     pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male     volunteers   "
126097|NCT01634555|"     The purpose of this study is to assess the effect of concomitant ramucirumab (IMC-1121B) on     the pharmacokinetics of irinotecan and its metabolite SN-38 when coadministered with folinic     acid and 5-fluorouracil, in participants with advanced malignant solid tumors resistant to     standard therapy or for which no standard therapy is available.   "
126098|NCT01634542|"     This multicenter, prospective, non-interventional study will evaluate the prevalence and     characteristics of patients with persistent symptoms of schizophrenia and the course of their     illness over 24 months.   "
126099|NCT01634529|"     The purpose of this study is to investigate whether V158866 is safe when given to healthy     male subjects in single and multiple doses.   "
126111|NCT01634373|"     Objective:      Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate     Tablets 300 mg.      Study Design:      Randomized, Two-Way, Crossover, multiple Dose, and Open-Label   "
126100|NCT01634516|"     There has been an increase in asthma and allergic disease prevalence, especially in children.     Given the high prevalence, and the associated high disease burden and costs, there is an     urgent need to identify effective strategies for the primary prevention of asthma and     allergy. A systematic review of the literature has found strong supportive epidemiological     evidence of a protective role for the Mediterranean Diet (MD).      The investigators aim is to undertake a pilot trial in a sample of pregnant women to     establish recruitment, retention, a measurable change to a dietary intervention encouraging     greater adherence to a MD during pregnancy, and acceptability of the dietary advice and diet     modifications.      This pilot study will be a 2-arm randomised controlled trial (RCT) in a sample population of     around 50 Scottish pregnant women.      This work ultimately aims to contribute to improving health outcomes through seeking to     reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable     in informing the subsequent planned definitive parallel group RCT.   "
126101|NCT01634503|"     This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety     profile the safety and maximum tolerated dose of GX-188E administered by electroporation in     Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.   "
126102|NCT01634490|"     Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively     evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of     the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A     food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance     acquisition. Main demographic and clinical characteristics were collected for each patient.   "
126103|NCT01634477|"     1. To describe the morbidity and clinical characteristics among HIV-infected patients and          HIV-uninfected patients.        2. To identify the risk factors for the complication or morbidity among HIV-infected          patients and HIV-uninfected patients.        3. To describe the mortality among HIV-infected patients and HIV-uninfected patients.        4. To identify the risk factors for the cause of death among HIV-infected and          HIV-uninfected patients.   "
126120|NCT01634256|"     The investigators performed a double-blind parallel study in a group of showing mild hepatic     injury subjects who were given Fermented turmeric over a period of 12 weeks. The     investigators measured liver function parameters , including ALT(Alanine Transaminase),     AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and     serum bilirubin, and monitored their blood pressure.   "
126632|NCT01627561|"     The current study will evaluate the immunogenicity and safety of Cervarix when administered     according to a 2-dose schedule with or without co-administration of GSK Biologicals' MMR and     DTPa vaccines in 4-6 years old female subjects as compared to the standard 3-dose schedule in     15-25 years old female subjects, the population in which the clinical efficacy has been     demonstrated.   "
126104|NCT01634464|"     In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the     programming of obesity in early stages of life. This can be achieved by studying pregnant     women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how     these conditions could impact on fetal growth and development; the risk of obesity in the     offspring during the first 3 years of life will be also assessed (genetic polymorphisms of     the most recognized genes related to obesity; gene expression of placental biomarkers     indicators of early programming, polyunsaturated fatty acids, immunological and     pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies     & neurodevelopmental assessment...). Moreover, the interaction of pathological maternal     conditions with confounder factors that could have a role in the proposed outcomes will be     also studied (maternal and child dietary intake, medical history and socioeconomic &     environmental factors).   "
126105|NCT01634451|"     Intensive Care Units (ICUs) across Scotland are working with the Scottish Patient Safety     Programme (SPSP) to reduce healthcare associated infections (HAls). This is being done     through implementation of care bundles. Ensuring that ICU patients get the correct amount     of sedation (medicine that makes patients sleepy) is part of this bundle, but is proving the     most difficult to get right. It's important healthcare staff (nurses and doctors) get     sedation levels correct because too much sedation is linked with increased hospital acquired     infections (HAIs), longer intensive care (ICU) and hospital stays, and possibly higher death     rates. This quality improvement project will develop and introduce three interventions that     may improve sedation practice: first, an ICU sedation education package; second, feedback of     sedation-related performance data (graphs and charts); and third, introduction of a CE     (Conformité Européenne - With the CE marking on a product, the manufacturer ensures that the     product conforms with the essential requirements of European regulations) marked new     technology designed to improve sedation management. The investigators will study the effect     these interventions, in different combinations, have on sedation management and quality in     the participating ICUs. Eight ICUs in Scotland will take part in the project, pairs (2 ICUs)     will be assigned randomly to different combinations as follows: 1.Enhanced education alone,     2. Education plus process/outcome measure feedback (graphs and charts), 3. Education plus     introduction of a new sedation monitoring technology, or 4. Education,process/outcome measure     feedback, and sedation monitoring technology. The investigators will evaluate which     combinations of education, feedback, and technology provide the most patient benefit in the     NHS. In addition both nursing & medical staff will be observed in clinical practice &     interviewed about their clinical practice to increase understanding about sedation management     from different view points and inform the education package content. These data will also     help implement the findings after the research is completed if a benefit is found.   "
126106|NCT01634438|"     At present, coronary angiogram is usually performed either through an artery in your groin or     wrist. An important limitation of the wrist approach is an increase rate of blockage of the     wrist artery. It is possible that the dose of blood thinner (i.e. heparin) may decrease the     risk of blockage. Early studies seem to suggest that higher dose is required to reduce the     risk of this important complication. However, to date there has not been a definitive study     to determine the most appropriate heparin dose for the prevention of this complication. The     main goal of this study is to determine the appropriate heparin dose to prevent wrist artery     blockage and to determine risk factors for developing such a complication.   "
126107|NCT01634425|"     The purpose of this study is to determine if early diagnosis and risk stratification acquired     through pre-hospital clinical assessment, 12-lead electrocardiogram and point of care     biomarkers will facilitate enhanced triage and treatment in patients with presumed non-ST     elevation acute coronary syndromes (NSTEMI).   "
126108|NCT01634412|"     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for     bedtime use. The present trial is designed to assess the safety and tolerability of     sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in     increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1     and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and     cyclobenzaprine (5 mg tablets, or 2.4 mg iv).   "
126109|NCT01634399|"     Objective:      Primary objective of the present study was to compare the single dose bioequivalence of     Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the study were separated     by a washout period of 7 days.      Study Design:      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study   "
126110|NCT01634386|"     Objective:      Primary objective of the present study was to compare the single dose bioequivalence of     Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by     a washout period of 7 days.      Study Design:      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study   "
126113|NCT01634347|"     The treatment involves administering propranolol, a medication indicated for treating high     blood pressure. Propranolol is hypothesized to reduce the strength of drug or alcohol     cravings (an integral factor involved in relapse), specifically when memories of substance     use are recalled. In this study, propranolol or a placebo will be administered to patients     participating in a drug or alcohol rehabilitation facility once a week over three or six     weeks. After receiving propranolol or placebo, strong memories associated with substance     craving are recalled by asking participants to read aloud a summary of a substance use     experience. The investigators hypothesize that participants who receive propranolol will     report fewer and less intense drug or alcohol cravings than participants who receive the     placebo or treatment-as-usual.   "
126114|NCT01634334|"     The purpose of this study is to determine if real-time feedback (lights/sounds) from small     smoke particle monitors and brief coaching will encourage parents to reduce young children's     secondhand tobacco smoke exposure in their home.   "
126115|NCT01634321|"     The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot     Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.   "
126116|NCT01634308|"     The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP     compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor     augmentation.   "
126117|NCT01634295|"     The aim of present study is to evaluate the efficacy and safety of two dose combination of     S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine     monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.   "
126118|NCT01634282|"     The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in     patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate     the efficacy of OPC-262   "
126119|NCT01634269|"     The primary objective of the present trial is to demonstrate the effectiveness of the     MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic     annuli and deemed difficult for surgical operation.   "
126121|NCT01634243|"     The primary objective of this trial is to establish the maximum maintenance dose of SPM 962     in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by     conducting safety evaluation of each patient following once-daily transdermal doses of SPM     962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard     8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation     period) Exploratory evaluation of each patient's maintenance dose will also be conducted with     attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will     also be examined.   "
126122|NCT01634230|"     This study is in patients with acute liver failure who are not responding to standard of     care.   "
126123|NCT01634217|"     This is a phase I single center dose escalation study with an extension at the best available     dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to     adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem     cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5 dose cohorts     will be tested. Once the tolerable dose is determined for iTregs, enrollment will continue     with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF) graft-versus-host     disease (GVHD) prophylaxis to gain further safety information and to provide pilot data in     this treatment setting.   "
126124|NCT01634204|"     Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in     the modern society, it is important to search for new strategies to counteract this. In     contrast to in person support, the internet provides a low cost opportunity, which is able to     reach a large part of the population. Therefore a web-based weight loss program may be an     adequate mean for many people. Now it is hypothesised that a web-based weight loss program is     able to support a reduction of body weight and weight-related cardiovascular risk factors     effectively and to promote a healthier lifestyle. It is expected that program use, compared     to a control group, results in greater reductions in body weight and cardiovascular risk.   "
126125|NCT01634191|"     The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics,     and the safety of a single oral dose of 30 mg of apremilast in healthy subjects.   "
126126|NCT01634178|"     The purpose of the study is to evaluate the effects of a high fat meal on the     pharmacokinetics of a single dose of 30 mg of apremilast in healthy subjects.   "
126127|NCT01634165|"     This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There     will be at least 6 days between each injection.      The study will compare LY2963016 to Lantus at two different doses.      This study is approximately 10 weeks long, not including screening. Screening is required     within 4 weeks of the start of the study.   "
126128|NCT01634152|"     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation     solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over     12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children     (6 to 11 years old) with severe persistent asthma.   "
126129|NCT01634139|"     The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation     solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over     48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent     asthma.   "
126164|NCT01633684|"     Because the diabetics are fracturing at a younger age than the general population (12), this     leads us to believe there are significant factors that lead to fracture in Type 1 diabetes     mellitus (DM) other than bone mineral density (BMD). Very little longitudinal data exists on     BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data     exists on pQCT in adults with Type 1 DM.      Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral     density (BMD) as measured by DXA compared to age and sex matched healthy controls.   "
126130|NCT01634126|"     Colorectal cancer (CRC) is a leading cause of cancer death in the United States. Screening     for CRC reduces CRC mortality, yet rates of screening in the United States remain low. Fecal     occult blood testing (FOBT) has an established positive balance of benefit and risk, is the     least expensive, and is the preferred method for nearly half of patients. A newer fecal     screening test, the fecal immunochemical test (FIT), offers significant improvements over the     FOBT. It is easier to use and is more sensitive at detecting both CRC and precancerous     adenomas than the FOBT. The OC-Micro FIT is of particular interest because it is highly     sensitive and specific and it is the only FIT test approved in the US that can be processed     in an automated manner. Thus, the OC-Micro is an optimal method for use in mass screening     programs to improve community CRC-screening rates. However, prior studies of OC-Micro suffer     from several limitations: they were conducted in populations not optimal for assessing     screening performance in average risk patients in the U.S. and the studies did not clearly     establish optimal number of samples required and cut-points for test positivity. Therefore,     the overall goal of MY-FIT is to capitalize on the highly integrated and extensive electronic     medical record system of the study site to collect two separate sets of data that, when     synthesized, will provide a thorough picture of the comparative patient adherence to,     sensitivity, specificity, and costs of different protocols for using the OC-Micro FIT.     Specifically, among KPNW members aged 50-75 who are at average risk for colorectal cancer     (CRC) and who are due for CRC screening (n=78,000), the investigators propose to:        1. Compare the sensitivity, specificity, positive predictive value, and negative predictive          value for colorectal cancer and advanced adenoma (advanced neoplasia) between a          single-sample FIT (1-FIT) and a two-sample FIT (2-FIT) using varying cut points for a          positive test (n=2100).        2. Compare patient adherence to completion of a 1-FIT versus a 2-FIT protocol (n=3000).        3. Assess and compare cost per screen for a 1-FIT versus a 2-FIT protocol, and the cost per          advanced neoplasia detected in a 1-FIT versus a 2-FIT protocol (using varying cut points          for a positive test) (n=78,000).      Answering the above questions will provide a much-needed strong evidence base for a     best-practice, cost-effective method of using the OC-Micro FIT to screen for CRC in a general     U.S. population.   "
126131|NCT01634113|"     The primary objective of this trial is to evaluate the safety and efficacy of two doses of     tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the     afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled     corticosteroid (ICS) treatment.   "
126132|NCT01634100|"     The objectives of the trial are to investigate the effect of concurrent administration of     rifampicin and probenecid on the pharmacokinetics of empagliflozin.   "
126133|NCT01634087|"     This is a study of INCB039110 in patients with chronic plaque psoriasis. This study will     evaluate safety and efficacy parameters of INCB039110.   "
126134|NCT01634074|"     The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep     therapy device.   "
126135|NCT01634061|"     This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone     acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.   "
126633|NCT01627548|"     A pilot intervention of an existing intervention adapted for the returning warfighter     population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes     reducing the PTSD avoidance/numbing symptoms that are corrosive in families.   "
126136|NCT01634048|"     Obesity is a major problem worldwide and current dietary interventions are not proving to be     enough to cease the increase in levels of obesity and its detrimental side effects, such as     nonalcoholic fatty liver disease (NAFLD).      Existing data suggests that adjustments in the macronutrient composition of the diet, more     specifically the protein content, may have beneficial effects on body composition and an     antiobesegenic effect on appetite. This may be important in terms of controlling body weight     and reducing the amount of fatty tissue within our bodies and organs, and therefore     preventing obesity and its health related side effects.      The investigators will perform a study to investigate whether a high protein low energy diet     compared to a normal protein low energy diet, in overweight adults can modify appetite and     aid loss of weight and fat mass. Subjects will receive either a high protein low energy diet     (1.34g protein/kg body weight) or a normal protein low energy diet (0.8g protein/kg body     weight) in the form of 2 meal replacements and one conventional meal per day with 2 snacks     for 12 weeks.      HYPOTHESIS In overweight subjects with the metabolic syndrome, a 12 week dietary intervention     with a high protein low energy diet will lead to a reduced appetite, body weight and fat     mass, more specifically to a greater fall in levels of fat in the liver and pancreas than a     low energy normal protein diet.   "
126137|NCT01634035|"     The investigators are studying the correlation between Hba1c and the mean plasma glucose in     diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess     glycemic control over a 3 months duration in hemodialysis patients   "
126138|NCT01634022|"     Acupuncture is a popular complementary/alternative therapy that has been in use for thousands     of years for the treatment of various medical and psychiatric conditions, including Major     Depressive Disorder (MDD). In this study, the investigators applied the investigators     acupuncture-treatment-for-depression protocol, based on Traditional Chinese Medicine (TCM)     principles for treating MDD, to depressed patients not taking any antidepressant medications     (a protocol that the investigators previously piloted as a medication augmentation therapy     for partial responders with MDD).      The investigators specifically investigated the efficacy, safety, and tolerability of this     TCM-based protocol for such patients, as well as potential differences in outcomes between     weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture     monotherapy would be associated with a response rate of at least 50%, which the investigators     defined as a decrease in depressive symptoms from the beginning to the end of the study of     50% or more, and that the response would be greater among patients who received acupuncture 2     times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture     would be associated with minimal side effects.   "
126139|NCT01634009|"     SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional     edema is an important cause of death in children globally including Bangladesh. The death     rate among children hospitalized for SAM is still high. Severe malnutrition in children can     be successfully treated by using WHO guidelines with or without minor modification. Since the     Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the     treatment of children with SAM has gained ground, and huge amounts of RUTF are used     particularly in African countries. RUTFs are an energy-dense lipid paste enriched with     vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk     powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%.     Although the CTC model promises treatment of SAM at a considerably lower cost than the     previous inpatient model, the cost of RUTF is still considered a significant barrier to     universal roll-out of SAM treatment and has made CTC implementation too expensive in many     high-need countries.      The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of     raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy     protein has a cost per kg protein that normally is below that of skim or whole milk powder,     and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high     quality, complete protein that meets the daily protein requirements of growing children and     adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that     has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of     1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed     as the sole protein source at minimum recommended intake levels.      To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of     the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked     intervention trial 300 SAM children aged 6 to 59 months after completion of their     stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will     randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving     -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at     the outpatient department of this Dhaka Hospital of icddr,b.   "
126140|NCT01633996|"     In this research study, the investigators piloted a uniform acupuncture treatment protocol     among adults with depression who were taking an antidepressant medication that was providing     only partial or no symptom alleviation. The study's aims were evaluate the efficacy, safety,     and tolerability of acupuncture augmentation treatment among this population. The     investigators hypothesized that acupuncture as an augmentation treatment would be associated     with a response rate of at least 50%, which the investigators defined as a decrease in     depressive symptoms from the beginning to the end of the study of 50% or more, and that the     response would be greater among patients who received acupuncture 2 times per week (vs. 1     time per week). The investigators also hypothesized that acupuncture would be associated with     minimal side effects.   "
126141|NCT01633983|"     Central serous chorioretinopathy (CSC) is a disease of unknown origin however multiple     reports have indicated correlation of appearance of CSC with exposure to exogenous or     elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids     is upregulated in many inflammatory conditions, control of the inflammation may be beneficial     in reducing this level thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely     used to control different types of inflammation. The investigators are going to try an     escalating doses of MTX to treat CSC under full medical supervision.   "
126142|NCT01633970|"     This open-label, Phase Ib study that has six treatment arms is designed to assess the safety,     pharmacology and preliminary efficacy of atezolizumab (MPDL3280A; an engineered     anti-programmed death-ligand 1 [PDL1] antibody) administered with bevacizumab (Arm A) and     with bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (FOLFOX) (Arm B),     with carboplatin and paclitaxel (Arm C), with carboplatin and pemetrexed (Arm D), with     carboplatin and nab-paclitaxel (Arm E), and with nab-paclitaxel (Arm F) in participants with     locally advanced or metastatic solid tumors. The study includes dose escalation cohort for     establishing the maximum tolerated dose (MTD) or maximum administered dose (MAD) and then     expansion cohort will be initiated based on a selected dose level at or below the MTD or MAD.   "
126634|NCT01627535|"     This clinical trial studies optical imaging in assessing activity during surgery in patients     with brain tumors. New procedures, such as optical spectroscopy, may help doctors maximally     remove brain tumors and minimize damage to normal brain.   "
126143|NCT01633957|"     Until very recently, warfarin is still the best drug of choice for long-term anticoagulation     for patients with mechanical prosthetic heart valve. However, the complication of warfarin     account for 75 percent of the whole complication after the mechanical prosthetic heart valve     replacement.      Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models     using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2)     explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have     the potential to improve patient safety by reducing or eliminating serious adverse events.     The investigators conducted a prospective, randomized, blinded, two arm trial to test this     hypothesis.   "
126144|NCT01633944|"     The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is     effective in treating opioid-naive subjects, with moderate to severe chronic low back pain     (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of     time.   "
126146|NCT01633918|"     The purpose of this study is to find out whether an Internet-supported FeetEnergy approach     and two home works integrated in three health education lessons can increase adolescents'     active commuting to school and leisure-time physical activity and decrease their screen time.   "
126147|NCT01633905|"     Alcohol-dependence is the most widespread addiction in Western countries and leads to a wide     range of impairments at cerebral and cognitive levels. It has also been showed that     alcohol-dependence is associated with emotional disturbances, particularly for the decoding     of emotional facial expressions (EFE). In view of the crucial role played by EFE to develop     and maintain satisfactory interpersonal relations, this emotional processing impairment may     have deleterious consequences on alcohol-dependent patient's social well-being, and this     deficit is thus of particular clinical interest. Nevertheless, this deficit has up to now     been evaluated only by means of experiments using paradigms with low ecological value (i.e.     presentation of EFE in isolation and in the central vision field), while in the real life,     emotional stimuli are most frequently appearing together with other emotional stimulations     (particularly voices) and in the peripheral vision field. Moreover, the cerebral correlates     of this emotional deficit are still to be determined.      The present study thus aims at exploring the Emotional Facial Expressions (EFE) decoding in     alcoholism using a more ecological paradigm, based on peripheral presentation of emotional     crossmodal stimuli (i.e. the simultaneous presentation of emotionally congruent face and     voice).      Main aim: Determining the electrophysiological characteristics (latencies and amplitudes) of     the event-related components elicited among recently detoxified alcohol-dependent     participants, while performing an emotion-detection task on crossmodal stimuli (voices and/or     faces) presented centrally or peripherally, and comparing these characteristics with those     obtained among paired healthy participants.      Secondary objectives:        -  Exploring the electrophysiological pattern modifications among alcohol-dependent          participants for the emotional faces and voices decoding (unimodal conditions), using          spatio-temporal analyses methods.        -  Exploring the electrophysiological waves associated with peripheral crossmodal stimuli          processing among healthy participants.        -  Exploring the behavioral correlates (reaction times and accuracy) of the          emotion-detection task among alcohol-dependent participants while processing peripheral          stimuli.        -  Exploring the psychopathological comorbidities among alcohol-dependent participants and          their influence on the behavioral and electrophysiological results.   "
126148|NCT01633892|"     Traumatic facial injuries, especially those sustained in military combat, are characterized     by destruction of bone and soft tissue. While the bony structures of the face can be     reconstructed, it is difficult to return the soft tissue back to its original form. Many     times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of     improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat     is taken from areas throughout the body, usually the thighs or abdomen, with a small     liposuction tube. The fat is then transferred into the area that has lost volume or fullness.     The fullness of the soft tissue area may decrease over time because the transferred fat can     be reabsorbed by the body. Altering the current fat grafting procedure, slightly, could lead     to less reabsorption and a lasting fullness of the soft tissue area outcome of the fat graft     procedure.      The investigators are conducting this research study to help us improve the surgical     treatment of people who have suffered facial soft tissue loss as a result of trauma. The goal     of this research study is to see how each person's fat grafts will maintain the fat over time     and to measure the quality of life during a 9 month post-surgical follow-up period. The total     duration of participation is approximately 11-12 months. In this study, the investigators     will concentrate the fat in the fat grafting procedure to determine whether this process will     maintain the fat over time. The areas treated with enhanced fat grafts will be compared with     areas treated with standard of care fat grafts. At least two areas of your face will be     treated with fat grafts, (standard of care fat grafts and concentrated fat grafts).      This study is the second of two clinical studies at the University of Pittsburgh using each     person's fat graft with concentration of fat cells in the graft to observe if there is less     fat resorption compared to using fat grafts alone. Each study is using a different     concentration of fat in the fat graft compared to the first clinical study.   "
126149|NCT01633879|"     This study tests the effectiveness of the bilingual Health and Success program, which aims to     support Latino parents and schools in their efforts to promote the academic success and     healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of     HIV/AIDS in urban Latino communities.   "
126150|NCT01633866|"     The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil     magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center     (CCHMC).   "
126153|NCT01633827|"     In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep.     This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an     increased risk for developing high blood pressure. Currently, the best treatment for     obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose     (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the     upper airway from closing in most people, many people have difficulty sleeping with the mask     in place and therefore do not use the CPAP treatment. This research study is being conducted     to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will     improve OSA severity by altering some of the traits that are responsible for the disorder.   "
126154|NCT01633814|"     Older women have an exaggerated increase in blood pressure during exercise. However, the     reasons for this are unclear. It is important to investigate this phenomenon because a     greater blood pressure response to exercise has been associated with an increased risk of     stroke and mortality in otherwise healthy individuals. A unique aspect of aging in women is     the profound change in hormone levels (i.e. estrogen and progesterone) associated with     menopause. The influence of changes in estrogen and progesterone levels on the cardiovascular     responses to exercise is poorly understood. However, it has been suggested that these     hormones might change the responsiveness of the cardiovascular system. Possible mechanisms     that could account for these changes are the arterial baroreflex and feedback from the     exercising muscle (known as the exercise pressor reflex), both of which are known to     powerfully modulate blood pressure during exercise. However, to date, few human studies have     thoroughly examined the influence of changes in hormone levels on baroreflex function during     exercise or the exercise pressor reflex in older women. As such, the purpose of this research     project is to assess baroreflex function and the exercise pressor reflex in older women after     transdermal estrogen and placebo.   "
126612|NCT01627821|"     This investigation will be conducted as an interventional intention-to-treat clinical study     in a population of end stage heart failure patients who meet specific inclusion and exclusion     criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label)     and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with     Post-Auricular Connector to an active control group treated with the PMA approved Thoratec     HeartMate® II LVAS for Destination Therapy.   "
126155|NCT01633801|"     Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP.     The delivery of high flows decreases dilution of the inhaled oxygen and, by matching     patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole     inspiratory phase. In addition, a flow-dependent effect of continuous positive airway     pressure, possibly due to an air entrainment mechanism, has been documented in healthy     volunteers and in patients with COPD.      The investigators working hypothesis is that the use of post-extubation CPAP delivered via     nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2     values than infants extubated on to oxygen therapy.   "
126156|NCT01633788|"     This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in     patients with meibomian gland dysfunction (MGD) in the eyelids.   "
126157|NCT01633775|"     The purpose of this study is to compare three-year outcomes of re-trabeculectomy with those     of Ahmed glaucoma valve implantation in secondary surgical management of patients with     primary open angle glaucoma (POAG) and a history of previous failed trabeculectomy.   "
126158|NCT01633762|"     The aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose     metabolism including postprandial plasma responses of the incretin hormones GIP and GLP-1,     insulin, C-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure (REE)     3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4) levels of     markers of bone formation and resorption as well as serotonin, 5) markers of systemic     inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood and     saliva. Thus, the overall objective is to provide detailed knowledge on the physiological     role of gut microbiota combined with bioinformatic analyses of the functional implications of     changes in bacteria composition on the level of both species and phylum.   "
126159|NCT01633749|"     Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013     season for the prevention of influenza infection. The immunizing effect is being     investigated, as well as its tolerability and safety.   "
126160|NCT01633736|"     This study's main aim is to look at targeted strength training for muscles at the hips.     Specifically to consider whether targeted strength training not only effects strength of the     specific muscles but also ability to stand on one leg (single leg balance) as well as walking     in children with cerebral palsy? This study is a feasibility of method of investigation.   "
126161|NCT01633723|"     DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled,     single/multiple dosing, dose escalation clinical trial with open-labelled food effect study     of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after     oral administration in healthy male subjects.   "
126162|NCT01633710|"     The study will compare Padd, a non-invasive automated optical device which uses a functional     test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI) in     the detection of PAD using as a gold standard, colour duplex ultrasound, in participants     drawn from general practice, a hospital diabetic clinic and a tertiary vascular disease     referral centre. The study hypothesis is that Padd performs at least as well as ABPI in     detecting PAD.   "
126163|NCT01633697|"     The investigators hypothesize that education will improve exercise capacity, symptoms and     quality of life in patients with chronic obstructive pulmonary disease (COPD). In addition,     the investigators are interested in determining how education might alter various chemicals     in the blood and exhaled breath that reflect inflammation in the lungs and the body as a     whole.      The investigators plan to enroll 42 patients into this study, with half of them participating     at each of the two sites, Vermont Lung Center at the University of Vermont in Burlington,     Vermont, and at Baylor College of Medicine in Houston, Texas. Participants will undergo a     series of measurements and tests at the beginning of the study, receive formal education     about COPD over the next 2 weeks, return at 6 weeks for a brief refresher session, and     finally return after 12 weeks for repeat measurement and testing as was done at the     beginning. Participants will be asked to keep a diary of symptoms, medication, and exercise     during the study.   "
126165|NCT01633671|"     In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit     (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were     measured according to the standard hospital protocol. To definitively confirm or exclude APE,     all patients underwent an angiographic CT-scan of the thorax.   "
126167|NCT01633645|"     The primary objective of this study is to establish the objective response rate (complete     response + partial response) following treatment with VELCADE in combination with cisplatin     plus gemcitabine in patients with locally advanced (Stage IIIb) or metastatic (stage IV     non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for     advanced disease   "
126168|NCT01633632|"     The purpose of this study is to determine whether Hatha Yoga can improve the chances of a     successful smoking quit attempt.   "
126169|NCT01633619|"     The incidence of postoperative PJI is ranging from 0.5-2.5% for primary interventions and are     reported up to 20% for revision procedure. In addition, hematogenous PJI can occur at any     time after implantation and the risk of infection remains during the entire prosthesis     indwelling time. Prosthetic joint infections (PJI) are associated with significant morbidity     and costs to the healthcare system. Evidence for optimal management of PJI with best outcome     and lowest expenses is limited and recommendations between countries vary significantly.     There is unmet need to standardized diagnostic procedures and definition of infection as well     as achieve a consensus for uniform treatment guidelines.The European Implant Cohort Study     (EICS) is a multicenter European research project, including patients with PJI in a cohort     representative for Europe. The EICS is established jointly by the Orthopedic and Traumatology     surgeons, Infectious Diseases specialists and microbiologists of selected university and     non-university institutions across Europe. The principal aim of the EICS is to improve the     management of PJI and develop consensus guidelines across Europe. By systematic analysis of     consecutively included patients with PJI, factors associated with best outcome regarding     infection (assessed by the infection-free interval) and joint function (assessed by the     degree of pain, mobility, range of motion) will be determined in a longitudinal prospective     study with long-term follow-up. This is an investigator-initiated, open, prospective,     multicenter observational study. Participating study centers will be university or     non-university hospitals across Europe, which fulfill the following study conditions:        -  Close collaboration between infectious diseases specialists, microbiologists and          orthopedic/trauma surgeons,        -  Availability of appropriate microbiological methods (following standard recommendations          including sonication of removed prosthesis),        -  Availability a dedicated study team (study nurse and/or research fellow) for regular          eligibility screenings, patient inclusion procedure, real-time data collection and          patient follow-up.      This project may generate important scientific evidence for future guidelines regarding     management of PJI, has the potential to initiate new multicenter substudies in an establish     network, and may open further collaboration and exchange of skills between institutions     across Europe.   "
126613|NCT01627808|"     The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver     resection, through the Vigileo/FloTrac system.   "
126170|NCT01633606|"     The aim of the study is to develop a screening instrument, based on the nursing activities     score, by which we can distinguish medium care patients from the intensive care patients in     terms of nurse staffing.      The main study question is: What is the most discriminative NAS cut off for medium care     patient?      Each nursing shift the NAS and TISS 28 scores will be calculated for each patient who is     admitted to the 8 participating units.      Nurses will be asked to answer 3 questions (see detailed description here under)at the end of     their working shift concerning each patient appointed to them.      Each morning medical staff and head nurses will be asked 2 questions (see detailed     description here under) for concerning patient admitted to there ward.      In order to determine the NAS cut off for medium care patient, all morning questionnaire     scores will be compared to the NAS an TISS28 scores of that same morning.      Secondary study questions are:        -  Can NAS score based on one nursing shift predict the severity of care in the subsequent          nursing shift?        -  Is there a difference in appreciation of severity of care between nurses, head nurses          and medical staff?        -  Which variables influence the perception of severity of care?        -  How does NAS relate to TISS28, APACHE and NEMS?   "
126171|NCT01633593|"     Nowadays features for the diagnosis of delirium are:        1. Disturbance of consciousness (i.e. reduced clarity of environment awareness) with          reduced ability to focus, sustain or shift attention;        2. A change in cognition (such as memory deficit, disorientation, language disturbance) or          the development of a perceptual disturbance that is not better accounted for by a          pre-existing or evolving dementia;        3. The disturbance develops over a short period of time (usually hours to days) and its          severity fluctuates during the course of the day;        4. There is evidence from the history, physical examination, or laboratory findings that          the disorder is caused by the direct physiological consequences of a general medical          condition, substance intoxication or substance withdrawal.      Treatment of underlying clinical disease is important to remit the delirium. However, these     procedures alone are not enough to remit the delirium early and to prevent sequels. There is     a need for a specific and faster strategy to treat the delirium.      The investigators want to test the hypothesis that an Anticholinesterase Inhibitor     (donepezil) can reduce the duration of the delirium.   "
126172|NCT01633580|"     The purpose of the present study is to analyse if corifollitropin alfa, an agent for     prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day     2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.   "
126173|NCT01633567|"     For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living     in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown     great promise in reducing health risk behaviors across a variety of behaviors and population     groups by enhancing the relevance of the health information. The primary aim of this study is     to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs.     a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and     transgender (LGBT) smokers. The investigators anticipate that the culturally targeted     intervention will be more effective at helping LGBT smokers to successfully stop smoking than     will the non-targeted intervention.   "
126174|NCT01633554|"     IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33     has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We     aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.   "
126175|NCT01633541|"     To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction     chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for     the treatment of advanced cancer. It is hoped that the combination of this chemotherapy     regimen will allow cancer patients to keep their voice box and to improve/maintain     voice-related quality of life. The ultimate goal of this study is to prevent the surgery to     remove subjects voice box.   "
126176|NCT01633528|"     It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy     rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian     perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness     as well, which could result in better implantation and pregnancy rates after IVF or ICSI     treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on     pregnancy rate following frozen embryo transfer.   "
126177|NCT01633515|"     A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the     elderly utilizing intralesional cryosurgery.      10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo     intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus     the BCC is frozen. Treatment success will be determined according to biopsy results 3 months     after treatment   "
126178|NCT01633502|"     Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite     rapid invasive treatment, circulatory support using positive inotropes and mechanical support     with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments     during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%.     An alternative to current management is restoration of the volume of blood pumped by the     heart (cardiac output) using a ventricular assist device. In the acute setting this is     difficult but can be done using the Impella device which is a catheter-based, axial flow pump     that pumps blood directly from the left ventricle into the circulation thereby restoring     blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is     able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of     the current study is to reduce mortality and morbidity of patients with cardiogenic shock     using the Impella cVAD. The study will be carried out as a randomized multicenter study where     eligible patients will be randomized to receive conventional circulatory support or support     with the Impella device and inotropic support if needed. A total of 360 patients are planned     to be enrolled, and the primary endpoint will be death.   "
126179|NCT01633489|"     This is an observational, multi-center, international disease registry designed to collect     longitudinal data and create a knowledge base that will be utilized to improve the care and     treatment of patients with LAL Deficiency. Participation in the Registry by both physicians     and patients is voluntary.   "
126180|NCT01633476|"     The purpose of this study is to determine whether Cytomegalovirus (CMV) reactivation in     ANCA-associated vasculitis (AAV) patients can be effectively and safely reduced using an     antiviral agent (valaciclovir) and whether this in turn improves the function of the immune     system thereby also improving the body's ability to fight other infections.      The primary hypothesis is that repeated episodes of CMV reactivation in AAV patients drive     the expansion and functional impairment of CMV-specific T-cells, with increased     susceptibility to infection. Inhibition of CMV replication with valaciclovir will block     further stimulation of CMV specific T-cells and increase the functional capacity of the     immune system.   "
126181|NCT01633463|"     EMERGENCY CANCER PAIN DRAWS CANCER PATIENT TO EMERGENCY DEPARTMENT FOR TREATMENT. HOWEVER,     THERE HAS BEEN INCONSISTENCY AND INADEQUACY OF PAIN MANAGEMENT IN EMERGENCY DEPARTMENT. THIS     STUDY OBSERVES THE STATUS OF PAIN ASSESSMENT AND ITS ADEQUACY IN EMERGENCY DEPARTMENT IN A     TERTIARY CARE CANCER HOSPITAL.   "
126182|NCT01633450|"     One of the newest strategies to combat micronutrient deficiencies is the biofortification of     staple foods, where higher levels of minerals are obtained through breeding of staple crops.     The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when     compared with a control rice fortified with zinc just before consumption.   "
126183|NCT01633437|"     The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine     after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg     administered twice per day (BID) in healthy volunteers compared to placebo; and to     investigate the general safety, tolerability and pharmacokinetic profile of CX157 tablets at     steady state compared to placebo.   "
126184|NCT01633424|"     Given the extremely limited availability of donated organs, transplant candidates must be     carefully evaluated and selected to ensure the success of the transplant and value of the     organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well     established, however, listing criteria for psychosocial risk factors (e.g., understanding of     illness and transplant process, psychiatric history, support system, compliance, etc) is less     standardized. The purpose of this research is to study the psychometric properties (e.g.,     predictive validity) of the new pre-transplant Stanford Integrated Psychosocial Assessment     for Transplant (SIPAT) examination in patients who received heart, kidney, liver, or lung     transplant and underwent the SIPAT evaluation before treatment. This new screening tool was     designed to standardize the evaluation process of psychosocial risk factors and their     severity, in order to enhance predictions of medical and psychosocial outcomes of patients     post-transplant.      If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be     amenable to clinical intervention could be identified. In turn, this may assist in developing     a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of     minimizing preventable problems, mitigating risk, and optimizing graft survival, patient     function, and quality of life.   "
126185|NCT01633411|"     This is a feasibility study without a primary study hypothesis or statistical comparison.   "
126186|NCT01633398|"     The ASIAN HF Registry is the first prospective multinational Asian registry of patients with     symptomatic HF (stage C)11 including both HFrEF (ejection fraction <40%)3 and HFpEF (ejection     fraction ≥50%), with the broad purpose of determining the mortality (incidence) burden of HF     in Asian patients, and more specifically to define the burden and risk factors of Sudden     Cardiac Deaths (SCD), as well as the sociocultural barriers to preventive device therapy. The     study further aim to study the genetic variants associated with HFrEF versus HFpEF in our     large Asian cohort.      This proposed registry is expected to advance fundamental understanding of the burden and     predictors of preventable death among Asian patients with HF. The knowledge gained will be     critical for guiding resource allocation and planning preventive strategies to address the     unmet and growing clinical needs of patients with cardiovascular disease in Asia.   "
126187|NCT01633385|"     The investigators plan to study the variability of lung function parameters and bronchial     inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years     compared with an age- and sex-matched control group. The investigators will perform a     pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled     nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation.     Finally induced sputum is collected and a cell count is performed, and cells and supernatants     are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks.     The aim of this study is to define baseline values and the variability of possible outcome     parameters for future interventional studies.   "
126191|NCT01633333|"     Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of     colonoscopy involving the use of water as the sole modality to aid colonoscope insertion,     water exchange, has been described in recent research papers to decrease patient discomfort     and pain, and to reduce the need for sedation during colonoscopy when compared with standard     air insufflation. Carbon dioxide insufflation has been described to decrease patient     discomfort after colonoscopy. No randomized trial has so far compared the use of water     exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less     discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients     undergoing screening colonoscopy in two centers in Norway, one center in Poland and one     center in The Netherlands will be enrolled and randomized to examination of either of the two     methods.   "
126192|NCT01633320|"     The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index     (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients     undergoing general anesthesia.   "
126193|NCT01633307|"     Aim: to determine whether a nationwide teaching program delivered to medical doctors can     decrease the use of inappropriate intravenous lines in internal medicine   "
126194|NCT01633294|"     The aims of this study are to determine whether antibiotics administered routinely in women     presenting with premature rupture of membranes later than the 37+0 weeks of gestation can     alter the rate of maternal and neonatal infection and to compare these rates between prompt     (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to     antibiotic prophylaxis.   "
127028|NCT01622361|"     The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus     GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2     negative, lymph node positive, primary breast cancer in premenopausal women.   "
126195|NCT01633281|"     A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or     thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this     complication include drugs like gabapentin or pregabalin, which relieve symptoms only     partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or     thalidomide, which may compromise treatment outcome. This clinical study explores whether, by     intervening early in its course using acupuncture, progression of PN can be reversed,     stabilized or retarded thereby allowing continuation of treatment on schedule.   "
126196|NCT01633268|"     Objective: In this study we will develop and apply imaging techniques to perform the first     three-dimensional (3-D) measurements of brain biomechanics during mild head movement in     healthy human subjects. Biomechanics is the application of mechanics, or the physical     principles in action when force is applied to an object, to the anatomical structure and/or     function of organisms. Such techniques will be invaluable for building computational models     of brain biomechanics, understanding variability of brain biomechanics across individual     characteristics, such as age and sex, and determining brain sub-structures at risk for damage     when movement of the head is accelerated, such as during a traumatic event.      Study Population: Measurements will be performed on 90 healthy men and women aged 18-50.      Design: We will build upon the model pioneered by our collaborator, Dr. Philip Bayly. The     model places a human subject in a magnetic resonance (MR) scanner with one of two head     support units that allows a specific range of motion. Each head support is latched such that     it can be released by the subject, and results in either a rotation of the head of     approximately 30 degrees or a flexion-extension of the head of approximately 4 degrees.     Although both supports are weighted so that the motion is repeatable if the subject is     relaxed, the subject can easily counteract the weight. The resulting     acceleration/deceleration is small (in the range of normal activities, such as turning one's     head during swimming) and has been validated and used in other human investigations of brain     biomechanics. The subject repeats the motion multiple times during the MR scan under their     own volition and desired pace to measure motion of the head and brain.      Outcome measures: This project is a pilot study evaluating the potential of extracting     three-dimensional estimates of brain deformation, such as strain measurements, using MR     imaging. A primary outcome of this project will be a fast MR acquisition sequence for     measuring 3-D brain deformation. The sequence will be evaluated by applying the protocol to     human subjects, followed by preliminary quantification of the reproducibility and stability     of deformation measurements.   "
126197|NCT01633255|"     Background:      - The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment     imaging studies. It is designed to show tumors in which new blood vessels are growing.     Imaging studies with [18]F-Fluciclatide may help predict how well a tumor will respond to     therapy that will prevent the growth of new blood vessels. Researchers will test     [18]F-Fluciclatide before beginning treatment and after the first treatment cycle.     Participants may also have a third scan with [18]F-Fluciclatide between 2 and 7 days after     starting treatment to look for changes in blood vessel growth early after starting therapy.      Objectives:      - To test the safety and effectiveness of [18]F-Fluciclatide in predicting cancer treatment     outcomes.      Eligibility:      - Individuals at least 18 years of age who will have kidney cancer treatment to stop tumor     blood vessel growth.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Tumor imaging studies and biopsies will be performed before          starting the study.        -  Participants will have two positron emission tomography (PET) and computed tomography          (CT) scans. [18]F-Fluciclatide will be used for each scan. One scan will happen before          the start of cancer treatment, and the second will happen after the first treatment          cycle.        -  Participants may also have an optional third PET/CT scan with [18]F-Fluciclatide. This          scan will take place 2 to 7 days after beginning therapy.        -  Depending on the location of the tumor, some participants may have an optional magnetic          resonance imaging scan to look for changes in tumor blood flow and size. These scans          will be done within 3 weeks of each [18]F-Fluciclatide PET/CT scan.        -  The scans will be monitored with regular blood tests and vital signs.        -  Participants will be followed for up to 1 year after the study to look for overall          disease response to therapy.   "
126198|NCT01633242|"     Background:      - Muscular dystrophy can affect the muscles used for heart function and breathing. Treatment     usually involves drugs that help improve heart function. However, better types of heart     imaging studies are needed to improve treatment of heart problems related to muscular     dystrophy. Better heart imaging methods are especially needed for children with muscular     dystrophy. Researchers want to test different heart imaging methods in children with muscular     dystrophy. They will look at cardiac magnetic resonance imaging (MRI) and standard heart     function tests.      Objectives:      - To develop and test new methods for imaging the heart in children with muscular dystrophy.      Eligibility:      - Children and adolescents between 8 and 17 years of age who have muscular dystrophy.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will provide a blood sample at the start of the study. They will also have          heart function tests before having the imaging study.        -  Participants will have a cardiac MRI scan that will last up to 60 minutes. Some tests          will require a MRI contrast agent (a drug that helps the image appear more clearly on          the scan).   "
126199|NCT01633229|"     Background:        -  Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat          disorders that cause inflammation and immune system diseases. BMSC have been used to          treat graft versus host disease (GVHD), a complication that can develop after stem cell          transplants. BMSC have also been used to treat other post-transplant complications, like          marrow failure or tissue injury.        -  The National Institutes of Health (NIH) has developed a procedure for collecting and          preserving BMSC from volunteer donors. These donors have passed tests to ensure that          their cells are healthy enough to be used for treatment. Researchers want to use the          collected cells to treat people with GVHD, marrow failure, or tissue injury following          stem cell transplants.      Objectives:      - To test the safety and effectiveness of NIH-collected BMSC to treat complications from stem     cell transplants.      Eligibility:        -  Individuals between 18 and 75 years of age who have complications from stem cell          transplants.        -  Complications are acute GVHD, poor bone marrow function, or tissue or organ damage.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have imaging studies and blood tests.        -  Participants will provide blood, skin, and bone marrow samples before the BMSC          treatment. Additional samples, including tissue samples, will be collected after the          start of treatment.        -  Participants will have up to three BMSC infusions. There will be a week between each          infusion. Participants will be monitored closely during each infusion. Any side effects          will be treated.        -  Treatment will be monitored with frequent blood tests and physical exams.        -  After the end of the infusions, participants will have regular followup visits for up to          2 years.   "
126200|NCT01633216|"     This randomized clinical trial will assess the immune response in infants following     administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV     type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short     schedule with administration at two week intervals and the usual schedule at four week     intervals. The results of this study will guide the Global Polio Eradication Program in the     implementation of new strategies that may: 1) improve the quality of the response to     outbreaks following importation of wild poliovirus type 1 by shortening the interval at which     several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3     poliovirus by using bOPV in outbreak responses in countries with weak routine immunization     systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the     replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.   "
126201|NCT01633203|"     This study will assess the efficacy and toxicity of perioperative chemotherapy with     Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of     public hospitals in Santiago, Chile.   "
126630|NCT01627587|"     This is a two part study. Part A of the study will evaluate the metabolites of GSK221149     following single and repeat oral dosing and will also assess the pharmacokinetics of     GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study     will look at the pharmacokinetics of GSK221149 following a high fat meal.   "
126202|NCT01633190|"     -  Rotavirus Hospital Admissions Surveillance        -  Retrospective surveillance for 2010 and 2011 for hospital admissions in children aged 0          to 16 years due to rotavirus gastroenteritis will be completed by all centers of the          IMPACT (Immunization Monitoring Program, ACTive) pediatric hospital network.        -  Prospective surveillance of rotavirus-related admissions for children aged 0 to 16 years          was conducted in 2012-14 inclusive and will be performed for an additional three years,          2015, 2016 and 2017 at all 12 sites. Surveillance methodology will continue using the          same case-finding strategy and the same case report form as in past surveillance (Case          reporting is done electronically.        -  Emergency Department Burden of Disease Case finding for all-cause diarrheal illness          using ICD codes was undertaken prospectively for 2012 to 2014 and will not continue in          the years 2015-17 inclusive. Systematic stool sampling was carried out for cases of          gastroenteritis in children < 5 years of age presenting to the ED departments at the          IMPACT hospitals in 2012 and 2013 and 5 of the 12 center hospitals in 2014. This          component will not continue in to the 2015-17 protocol study years. However the admitted          cases presenting to the IMPACT center hospitals with positive rotavirus will be reported          and stool samples saved for genotyping at a later date.   "
126203|NCT01633177|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of     developing cancer, heart disease, and stroke in people who do not have a prior history of     these illnesses. This ancillary study is being conducted among nondiabetic participants in     VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from     this proposed study conducted within the VITAL trial will clarify whether vitamin D and     omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform     public health and clinical guidelines for diabetes prevention.   "
126204|NCT01633164|"     The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based     group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which     aims to enhance personal self-efficacy. A structured six-week, manualized, group therapy     intervention that delivers positive psychology concepts within a cognitive-behavioral     therapy-based model has been created for the purpose of developing a resilient and optimistic     sense of efficacy for people with SCI. Concepts covered within this intervention include:     reframing and restructuring a person's method of looking at events, building confidence by     focusing on personal strengths, developing methods of recognizing and appreciating the good     in one's life and expressing gratitude for positive attributes. The goals of this     intervention are to increase personal self-efficacy, enhance emotional well-being and improve     participation in society for people with SCI living in the community. The investigators     hypothesize that persons receiving the intervention will demonstrate improved SCI-specific     and overall self-efficacy as compared to waitlist controls.   "
126205|NCT01633151|"     The purpose of the study is to determine the precision of an unobtrusive sleep measurement     system. The system measures a force sensor signal under the mattress and analyzes sleep     quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate,     respiration rate, sleep related breathing disorders, and limb movements.   "
126206|NCT01633138|"     The purpose of this study is to investigate whether monetary reinforcement for performance     will enhance the effects of cognitive remediation therapy for substance users seeking     treatment at an outpatient facility.   "
126207|NCT01633125|"     The prevalence of psychological problems is high in prisons. Many prisoners have unmet needs     for appropriate treatments. Although pilot studies have suggested music therapy to be a     successful treatment modality for prisoners, more rigorous evidence is needed.      This study aims to investigate the effectiveness of group music therapy to improve anxiety,     depression, and self-esteem in prisoners. One hundred and ninety two inmates from a Chinese     prison will be allocated to two groups through randomisation. The experimental group will     participate in biweekly group music therapy for 10 weeks (20 sessions) while the control     group will be placed on a waitlist. Anxiety, depression and self-esteem will be measured by     self-report scales three times: before, at the middle, and at the end of the intervention.     Logs by prisoners and daily behavior observation by trained prison guards will be used as     additional information.      This study will increase the knowledge of the effectiveness of group music therapy. Results     will be generalizable to Chinese prisons but also internationally. Generalizability to     clinical practice will be high, and findings will be able support the further development of     music therapy in prison.   "
126208|NCT01633112|"     The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to     glatiramer acetate (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the     treatment of patients with relapsing-remitting MS (RRMS).   "
126209|NCT01633099|"     The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine     in the treatment of elderly Acute Myeloid Leukemia (AML) patients.   "
126210|NCT01633086|"     This is a randomized, double-blind, placebo-controlled, 2-period crossover, 12-week trial to     be conducted in 50 subjects with painful diabetic neuropathy. The objective of this trial is     to assess the safety and efficacy of NO gel, a NO donor, as compared with a placebo gel, in     symptom relief of subjects with painful diabetic neuropathy.   "
126211|NCT01633073|"     The aim of this randomized prospective study is to compare two single-use laryngeal mask     airways with a provision of a gastric drain tube allowing for evacuation of gastric contents,     the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure     ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not     be significantly different clinically (higher) when compared with the LMA Supreme.   "
126212|NCT01633060|"     This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and     safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast     cancer who progressed on or after mTor inhibitor based treatment.   "
126631|NCT01627574|"     The long-term objectives of this research are to develop effective treatments to reduce     unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served     at-risk youth population.   "
126213|NCT01633047|"     The anterior cruciate ligament (ACL) is frequently injured, and it is the structure of the     athlete´s knee which has the highest prevalence of reconstruction. Given this postoperative     ACL reconstruction scenario the investigator find in literature the effectiveness of     neuromuscular electrical stimulation (NMES) as an adjuvant treatment for strengthening the     quadriceps muscle. The intensity of NMES and the training duration are important factors for     a successful treatment.      The purpose of this study is to compare two rehabilitation protocols in patients during the     post operative of the ACL reconstruction over the strength of knee extension and control of     edema.      It will be a randomized controlled study with the CONSORT bases with 40 participants that     will be divided into two groups: Control group that will be submitted only to physical     therapy exercises, and the Intervention group that will be submitted to physical therapy     exercises plus electrical stimulation (low frequency device with a current of 47 Hz with     symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of     1.8 s). The procedure will last six weeks. It will be evaluated the pre intervention     quadriceps muscle extension force by means of a manual dynamometer, and the joint swelling     through the perimeter. This procedure will be repeated after six weeks of intervention.   "
126214|NCT01633034|"     The purpose of the research is to collect and examine spinal disc and ligament tissues to see     if there are any biological markers that can be correlated with MRI images to help us learn     more about causes of back pain. Spinal discs are the pillow-like cushions between the bones     of the spine. They act as shock-absorbers for the spine. Spinal ligaments support the disc     structure during movement.   "
126215|NCT01633021|"     Background:      - Knowing one s family medical history is a part of staying healthy. Some health risks run in     families, and knowing these risks can promote more healthy behavior. Different social and     cultural factors may affect how family members share this information. Genetic risk     information that is shared in one family may not be shared in the same way in another. This     information may also be shared differently between spouses, siblings, or parents and     children. It may even be shared with more distant relatives. Knowing the information that     family members share and how they share it may help researchers improve genetic disease     treatment and support plans. Family surveys of people who have genetic health risks may help     provide this information.      Objectives:      - To study how family members affected by genetic-related diseases share health information     with each other.      Eligibility:        -  Individuals at least 18 years of age who can read English or Spanish.        -  Participants affected by a genetic disease or be related or married to someone who has          the disease.      Design:        -  Participants will be screened with an initial questionnaire. They will identify their          genetic disease and provide a basic health history.        -  Participants who have the disease will complete an online survey or participate in a          personal interview. The questions will take about 45 minutes to 1 hour to answer. The          survey will ask about family health history and family support. Participants will also          provide referrals to a spouse or relatives who will participate in the study.        -  The spouse or relative will answer a similar survey. The survey will ask about health          history and support for the spouse/relative with the disease.        -  A gift card will be given as thanks for participating in the study.   "
126216|NCT01633008|"     Background:        -  Neurofibromatosis type 1 (NF1) is a genetic disorder that can cause frequent and          significant pain. This pain can have a severe impact on a person s quality of life.        -  Acceptance and Commitment Therapy (ACT) is a new type of therapy that may help people          manage pain. It teaches behavioral techniques that can be used to change how people          react to pain. ACT may help people with NF1 cope better with the pain associated with          the disorder. Researchers want to test ACT techniques to see if they can improve coping          in people with NF1 pain.      Objectives:      - To see if ACT can help treat chronic pain in adolescents and young adults who have NF1.      Eligibility:      - Adolescents and young adults between 12 and 21 years of age who have chronic pain     associated with NF1.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          complete a set of questionnaires about their pain levels, quality of life, and          medications that they are taking.        -  Participants will take part in a training workshop for ACT. It will consist of three          2-hour sessions over 2 consecutive days. The workshop will teach techniques for setting          goals that reflect personal values, and changing the focus from pain avoidance to pain          management. There will be practice exercises between each session.        -  At the end of the workshop, participants will receive a workbook with the exercises to          continue to practice at home. Participants will be encouraged to spend at least 20          minutes, three times per week, on these practice exercises.        -  There will be a followup phone call to check on pain management after the workshop.        -  Three months after the first study visit, participants will complete the study          questionnaires again from home. They will provide more information about how they are          managing their pain. The questionnaires will be returned by mail in an envelope provided          by the study team.   "
126217|NCT01632995|"     This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure     prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine     (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD)     clinics and a community health center in the United States.   "
126218|NCT01632982|"     This study will develop and evaluate the preliminary efficacy and cost-effectiveness of a     mobile phone-delivered psychosocial intervention for opioid-dependent adults (N=219) in     methadone maintenance treatment (MMT). A three-arm, randomized clinical trial will evaluate     the relative efficacy of: (1) standard MMT; (2) standard MMT plus the mobile intervention;     and (3) a mobile-based control condition on the primary outcomes of treatment retention and     opioid use (assessed via urine toxicology). If results are promising, this novel therapeutic     tool may have a tremendous impact on improving access to and effectiveness of substance abuse     treatment in a variety of other populations (and could also be adapted for an array of other     behavioral health applications), while significantly limiting costs.   "
126219|NCT01632969|"     The purpose of this study is to improve the quality of care provided for head and neck cancer     patients. By better understanding the end of life experiences of dying patients and their     families, the investigators hope to better anticipate and improve upon the experiences of     future patients and their families.   "
126220|NCT01632956|"     There are few breast cancer support groups that focus on the specific needs of Chinese women.     The purpose of this study is to learn about two different ways of providing support groups to     help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and     its treatment. The investigators want to learn about how best to support Chinese women with     breast cancer by providing two different types of groups: an in-person support group and a     virtual (online/phone) support group.   "
126663|NCT01627145|"     Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for     Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With     Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient     Perception of Bladder Condition.   "
126221|NCT01632943|"     This study is to evaluate efficacy and safety of renal denervation in the treatment of     uncontrolled hypertension. This study will enroll a minimum of 40 and a maximum of 45     subjects. The study will be conducted at up to 8 actively enrolling investigational sites.     The primary endpoint is change in Office Systolic Blood Pressure from baseline to 6 months     post-procedure.   "
126635|NCT01627522|"     Preoperative use of finastride will decrease the amount of perioperative blood loss during     and after TURP      The effect of finastride on decreasing the amount of perioperative blood loss during and     after TURP is dose dependent      Finastride will decrease microvascular density in prostate tissue and this effect is dose     dependent   "
126222|NCT01632930|"     The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis     of prostate cancer, the first human cancer and second leading cause of cancer death. Overall,     in more than half of cases, prostate biopsies performed in search of a prostate cancer are     negative. In this population, there is no consensus recommendation on how to care, leading to     repeated invasive biopsies, potential sources of complications.      The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the     positivity of prostate biopsies, especially in patients who had at least one negative biopsy.     Proposed in clinical practice in France as a commercial kit, it is expensive and is not     covered by health insurance. It is therefore essential to assess the medical and economic     impact of its introduction into medical practice.      The investigators propose to set up a study of high standard of proof, multicenter, based on     recruitment of patients treated in hospitals. This working hypothesis is that the     availability of the PCA3 test results would reduce the number of invasive biopsies performed     incorrectly in patients already had at least one negative biopsy, thus improving the     diagnostic strategy of prostate cancer.   "
126223|NCT01632917|"     The objectives of this trial are to evaluate the safety and tolerability of ATX-101     injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.   "
126224|NCT01632904|"     The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects     treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the     percent of subjects who achieve a clinically meaningful symptom improvement (ie, total     symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is     also designed to demonstrate that these responses are durable with continued treatment.   "
126225|NCT01632891|"     The purpose of this study is to see if antiretroviral therapy (ART) is safe and works at     getting rid of malaria in blood and to see whether one type of ART is better than another.     This study may offer information for further research in looking at whether ART plays a role     in the prevention and treatment of malaria.   "
126226|NCT01632878|"     The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection     initiative, first compiling data on the current treatment of post myocardial infarction     patients (screening-log) and then, prospectively evaluating only those patients being     prescribed Omacor as part of their standard secondary prevention treatment. The aim is to     observe the Omacor cohort of patients for a period of 12 months, collecting long term     observational data as clinical and patient-reported outcomes, especially, but not     exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive     Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or     interventions will be mandated. Only results from routinely performed tests, labs, procedures     and/or interventions will be collected if available.   "
126227|NCT01632865|"     To evaluate whether recanalization and stenting for symptomatic subacute and chronic     veterbrobasilar artery occlusion is technically feasible, can prevent from recurrent ischemic     events and promotes functional recovery of disability.   "
126228|NCT01632852|"     This is a first in human, prospective, multicenter, nonrandomized, open-label,     dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and     immunogenicity of repeat doses of CSL362.   "
126229|NCT01632839|"     The primary objective of this study is the psychometric validation of two questionnaires     (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on     female sexual function (FSFI).   "
126230|NCT01632826|"     To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a     likelihood of benefit from the pomalidomide treatment while the medication is not     commercially available   "
126231|NCT01632813|"     The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the     hypothesis that children with a congenital heart disease (CHD) show more neurocognitive     impairment at the second follow-up at 7 years old than at the first follow-up at the age of     4, compared to healthy controls.   "
126232|NCT01632800|"     This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing     the time required for imaging. Experience has shown that unpleasant side-effects from     magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when     the magnetic pulses are shortened. In this study, we will explore whether this effect holds     true when very short magnetic pulses are applied.   "
126233|NCT01632787|"     Patients with acute exacerbation of chronic headache disorder present frequently to the     Emergency Department (ED) for pain management. A novel etiology of headaches is Vertical     Heterophoria (VH), a poorly understood and little recognized binocular vision malady that     when treated with realigning prismatic spectacle lenses results in marked reduction in     headache and other associated VH symptoms.      This study aims to determine the accuracy of the Vertical Heterophoria Symptom Questionnaire     (VHSQ) in identifying a ED headache patients who will experience significant reduction in VH     symptoms with use of realigning prismatic spectacle lenses. This study's secondary purpose is     to determine if VH is a common cause of chronic headache disorders in ED headache patients.      To achieve these goals, a prospective observational study will be performed on ED headache     patients > 18 years old. All will be given the VHSQ, and all will be assessed for a diagnosis     of VH by an optometrist who will utilize a novel VH testing method. High and low score groups     on the VHSQ will then be compared to each other to determine the prevalence of VH in each.   "
126234|NCT01632774|"     Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents     relatively rare, but potentially serious leading to death at scene in most of the cases. The     study was undertaken to delineate mortality and its risk factors on three different levels     (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and     victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and     autopsy records.   "
140475|NCT01445964|"     An open-label, single-dose, three-treatment, three-period study to investigate the effect of     SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in     healthy male Korean.   "
126760|NCT01625884|"     In Turkey statin compliance is lower than EU countries. (EURIKA). We will assess the     underlying causes of statin incompliance. The investigators will build patient and physician     education programs to improve compliance in TURKEY. Our aim is to assess patients' and     physicians' attitudes to statins by mean of HABIT Patient and Physician survey respectively.   "
126235|NCT01632761|"     The VITamin D and OmegaA-3 TriaL (VITAL; NCT01169259) is a randomized clinical trial in     20,000 U.S. men and women studying whether taking daily dietary supplements of vitamin D3     (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study is being conducted among VITAL participants and will study     whether vitamin D or fish oil: (A) in the overall VITAL cohort, reduces the number of persons     diagnosed with anemia and (B) in a subcohort of 900 participants seen in Boston, effects     long-term changes of the proteins in blood in both anemic and non-anemic individuals who     provide blood samples at the start of the study and again 2 years later.   "
126236|NCT01632748|"     This research is being carried out in order to compare two alternative versions of the     Neurotech Vital Devices which have been set up to provide two different types of stimulation.     Both these devices will be fully functioning devices and the investigators want to collect     information on your perception of the two alternative modes. The patient will be asked to     provide feedback on both devices which will look identical. The patient will not be told in     which order the units were given to them until the completion of your visit.   "
126237|NCT01632735|"     The primary purpose of this study is to test the effectiveness of a pilot mobile based     continuing care program (monitoring/feedback texting) relative to standard continuing care as     usual in reducing relapse and improving psychosocial functioning outcomes in a youth     population (under 24) with substance abuse problems.   "
126238|NCT01632722|"     Early-stage colorectal cancer(CRC)is localized and resectable, but 20% of the patients have     metastatic disease at the time of diagnosis and 50% of all patients eventually die of the     disease. The most frequent site of colorectal metastases is the liver, which accounts for 30%     to 60% of cases. In these patients, the extent of liver disease is the main determinant of     survival. Hepatectomy is the only potentially curative therapy for colorectal liver     metastases (CLM), but when traditional criteria for resectability were used, only 10% of     patients were candidates for surgical resection.      Although adjuvant systemic therapy after resection of primary colorectal tumors is well     established, there are relatively few data on the use of postoperative therapy vs. surgery     alone in patients who have undergone resection of liver metastases. In this trial, the     absolute increase in the 3-year PFS rate with the addition of FOLFOX4 was a modest but     significant 9% in patients who had resection (from 33% to 42%; P = .025). For improving     survival in patients with CLM, several studies with biologic agents have been tried. The use     of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), has     resulted in increased response rates in patients with stage IV colorectal cancer and improved     OS and PFS. In an ongoing phase II trial presented in ASCO 2008, in patients who were     potentially curable through resection of liver metastases, perioperative treatment with     capecitabine and oxaliplatin (XELOX) plus bevacizumab yielded an overall response rate of 73%     with stable disease in 21% and a mean PFS of 27 months. Response to chemotherapy     significantly correlated with a prolonged PFS (P < .001).      On the basis of these backgrounds, we designed a phase II study to compare the effectiveness     of combination chemotherapy with perioperative or postoperative bevacizumab treatment in     patients with CLM.   "
126239|NCT01632709|"     The purpose of this study is to see how Post Amputation Pain (PAP) affects the body and brain     by using sensory testing (such as pinprick testing), taking pictures of your brain (using a     functional magnetic resonance imaging (fMRI) machine) and biomedical interventions (such as     an injection of pain medicine). All medicines and the fMRI machine used during this study are     FDA approved. The investigators hope that by learning the causes of PAP, the investigators     can help future amputees.   "
126240|NCT01632696|"     Tumor Imaging of I-124 PGN65 in Solid Tumors   "
126241|NCT01632683|"     This study evaluates success rates of tracheal intubation (passing a breathing tube)for     patients who may be more challenging to intubate while utilizing one of two devices that     facilitate placement of the tube with video technology.   "
126242|NCT01632670|"     The purpose of this study is to determine the effect of music therapy before, during, and     after cardiac catheterization is associated on (a) change in reactive hyperemia index     measured before and after catheterization using peripheral arterial tonometry and (b) patient     stress and discomfort measured by a questionnaire, as compared to the standard of care (no     music during cardiac catheterization).      The hypothesis of the study is that music therapy during cardiac catheterization will be     associated with more favorable change in reactive hyperemia and higher patient satisfaction     compared to no music playback.   "
126243|NCT01632657|"     Patients with unruptured brain aneurysms and pain syndromes like trigeminal neuralgias often     undergo minimally invasive brain surgery with a smaller incision,shorter duration of     procedure and in some patients the possibility of going home on same day. Postoperative pain,     nausea and vomiting are sometimes difficult to manage with conventional medications. This     affects recovery from surgery and often delays discharge from the hospital. This study looks     at the use of a medication called sumatriptan which is a drug that has been used in the     treatment of migraine headaches for a very long time. This drug works on the receptors in the     lining of the brain and around the nerves which maybe associated with pain. The purpose of     this study is to determine if this pain medication sumatriptan given at the end of the     surgery improves the postoperative course in terms of less pain, less nausea and vomiting and     generally having a better postoperative quality of recovery.      Our main hypothesis is that subcutaneous sumatriptan (6mg) administered at the end of surgery     will improve the postoperative quality of recovery at 24 hours after elective minimally     invasive craniotomies.   "
126244|NCT01632644|"     The primary objective of this study is to investigate the patient experience during skin     biopsy.   "
126245|NCT01632631|"     Ongoing technological advances, especially in the field of image processing, have refined     medical simulations to offer life-like replications of medical and surgical procedures in a     variety of specialties. Patient-specific image data are incorporated into these simulations,     and transformed into a 3D model. This enables the practitioner and his/her team to perform     and practice 'real' cases on a virtual patient prior to performing the real procedure on the     actual patient. This new technology has been referred to as 'patient-specific' rehearsal,     also 'mission' or 'procedure' rehearsal.      Research has already proven that simulated patient-specific rehearsal of a carotid artery     stenting procedure may enhance surgical and team performance.      The PROcedure rehearsal software can now also be used to practice patient-specific     endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a     challenging and complex procedure like EVAR may not only influence device selection based on     preoperative planning, but also improve the technical performance of the surgeon/radiologist     and the awareness and communication within the entire endovascular team. However, further     research is needed to evaluate if this new technology may enhance clinical safety and     efficiency, i.e. if patients actually benefit from physicians and team members conducting     patient-specific rehearsals of EVAR interventions.   "
126246|NCT01632618|"     Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most     frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all     visits to physicians for LBP involve individuals over 65. In older adults, LBP has been     associated with a host of negative consequences, including decreased physical function,     increased fall risk, increased mood disturbance and increased health care utilization.     Surprisingly, little research has focused on LBP in people over 65. But, recent evidence     demonstrates that LBP is associated with increased intramuscular fat infiltration in the     abdominal and paraspinal muscles and that this altered muscle composition increases the risk     of mobility-related functional decline in older adults. While trunk muscle training (TMT) has     been used in younger LBP groups, it is unproven in elders and, alone may not be sufficient to     substantially improve function and symptoms, given the compromised state of ages muscle. TMT     augmented with neuromuscular electrical stimulation (NMES) known to improve strength and     function beyond the capacity of volitional exercise alone, may provide greater improvements.     Treatment of chronic LBP in older adults using an exercise intervention has been hypothesized     as a way to prevent functional decline and frailty progression; however this hypothesis has     yet to be experimentally confirmed. In this exploratory study, the investigators will test     the hypothesis that TMT plus NMES will result in reduced disability and pain severity     compared to usual care in elders with chronic LBP.   "
126247|NCT01632605|"     The purpose of this study is to evaluate the safety of a daily single oral dose of sirolimus     in patients with advanced autosomal dominant polycystic kidney disease.   "
126248|NCT01632592|"     Obesity is strongly associated with risk of cardiovascular disease (CVD). Data increasingly     suggest that visceral adipose tissue (VAT) accumulation -- or increased abdominal fat -- is     particularly deleterious to cardiovascular health, but further study is needed to test this     idea. Increased abdominal fat may also be associated with lower secretion of a hormone called     growth hormone (GH), which helps the body burn fat. The current study aims to carefully     characterize relationships between abdominal fat and CVD. In addition, by using a medication     called growth hormone releasing hormone, which is a strategy to reduce abdominal fat, the     investigators will test the hypothesis that abdominal fat contributes uniquely to increased     arterial inflammation.      In the first part of this study, the investigators will investigate both lean (healthy     weight) individuals and individuals with increased abdominal fat. The investigators will     study their body composition, cardiovascular risk measures, insulin sensitivity, and growth     hormone dynamics, with the hypothesis that abdominal fat, independent of general obesity,     will be strongly associated with arterial wall thickening and atherosclerotic inflammation.     The investigators will assess arterial wall thickness, plaque morphology, and atherosclerotic     inflammation, and the investigators will determine associations between these variables and     regional fat accumulation, with particular attention to abdominal fat.      The second, treatment part of the study will be only for individuals with increased abdominal     fat who are found to have low growth hormone secretion. In that part of the study, the     investigators will test the effects of a growth hormone releasing hormone (GHRH) analogue to     reduce abdominal fat and, consequently, reduce arterial inflammation. The investigators     hypothesize that abdominal fat reduction, independent of changes in growth hormone, will     reduce arterial inflammation and arterial wall thickness.   "
126249|NCT01632579|"     This is a phase I study of LY3023703 in healthy participants. The purposes of this study are     to look at safety, how well the study drug is tolerated, how much of the study drug gets into     the blood stream, and how long it takes the body to get rid of it when given to humans.     Information about any side effects that may occur will also be collected. Participants will     remain in the study for approximately 3 months. This study is for research purposes only and     is not intended to treat any medical condition.   "
126250|NCT01632566|"     The purposes of this study are to look at safety, how well the study drug is tolerated, how     much of the study drug gets into the blood stream, and how long it takes the body to get rid     of it when given to healthy Japanese and non-Japanese participants as multiple doses. In     addition, effects of 28-day oral dosing of LY3131207 on the amount of a cholesterol-lowering     drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of     it will be determined. The effects of LY3131207 after single and 28-day dosing on blood     pressure will also be studied. Information about any side effects that may occur will be     collected.   "
126251|NCT01632553|"     This study looks at the biological effect of domestic violence and abuse (DVA) on women's     mental health. The mechanisms through which DVA causes mental disorders are very poorly     understood. Similar to other demands, DVA activates the biological stress system, of which     the chief component is the hypothalamic-pituitary-adrenal (HPA) axis, which produces chemical     cortisol. Cortisol levels increase in response to short-term demand and help organisms deal     with it by changing the processes of getting energy from food and also mental function.     However constant activation of the HPA axis can cause damage and accelerate disease.      This study tests the hypothesis that compared to non-abused women all abuse victims have     altered diurnal rhythm in cortisol secretion and that the pattern of this alteration is     predicted by abuse characteristics, such as its type, severity, duration, and cessation. To     examine the hypothesis the following research questions will be addressed: 1) whether     cortisol levels are related to mental health state; 2) whether cortisol levels are related to     type, severity, duration and cessation of DVA; 3) whether there is any difference in cortisol     concentrations between those women exposed to both childhood abuse and DVA and those who have     experienced only the latter; 4) whether cortisol levels vary between women, living in refuge     and those not living in refuge?      To answer these research questions 214 women will be recruited in a domestic violence agency.     Baseline and 3-monthly follow-up measures will be taken over 6 months after recruitment.     Women will be asked to fill in a questionnaire to evaluate their demographics, health,     experience of childhood abuse and DVA. Women's weight and height will be taken. In addition     participants will be asked to take three saliva samples: 1st in the evening in bed, 2nd -     next morning immediately upon awakening, and the 3rd - in thirty minutes after awakening.     Saliva will be collected by chewing (for 2 minutes) the cotton pledget provided with plastic     tube and returned by post or via collection by the researcher. Then the saliva samples will     be tested for cortisol and cortisone.      Results of the study will increase our understanding of the biological mechanisms of DVA     impact on a woman's health and tell researchers and practitioners about the possibility of     using cortisol as an indicator to diagnose abuse-related health problems and assess     effectiveness of medical care for abuse survivors.   "
126252|NCT01632540|"     This study will be a prospective observational study of real world BDP nasal aerosol users     with PAR, with or without seasonal allergic rhinitis (SAR). Subjects will respond to monthly     online surveys regarding rhinitis control, concomitant medical conditions, concomitant     (non-AR) medications, current AR therapy, and adverse events.   "
126253|NCT01632527|"     The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of     unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy     secondary to age-related macular degeneration.   "
126254|NCT01632514|"     Hypocalcemia is a frequent adverse event after thyroidectomy. It is usually related to     hypoparathyroidism, but preoperative hypocalcemia, hypomagnesemia or vitamin D deficiency     contributes to it. This study aims to determine the frequency of vitamin D deficiency or     insufficiency in patients submitted to thyroidectomy, to define the risk attributed to     vitamin D deficiency to postoperative hypocalcemia, to identify other factors associated to     postoperative calcium disorder, and to evaluate the benefit of preoperative treatment of     vitamin D deficiency to prevent postoperative hypocalcemia.   "
126272|NCT01632280|"     In this project the investigators aim to improve eating control and weight loss outcomes in     patients undergoing LAGB with an innovative brain-based intervention. Specifically, the     investigators will enhance the activity of the right inferior frontal gyrus, a core region of     the brain circuit of inhibitory control, using transcranial direct current stimulation     (tDCS).   "
126255|NCT01632501|"     The freedom of choice in medicine is based on the physician's ability to treat their patients     with the best available therapy. The armamentarium for percutaneous intervention is     frequently determined on the basis of subjective criteria and the experience of the     interventional cardiologist. The evaluation of devices used in coronary intervention,     especially angiography and its clinical outcomes, has rarely been investigated; the     exceptions are studies on stents. Therefore, the freedom of choice for the interventional     cardiologist has been challenged, especially because of cost restrictions. This way this     study aims to assess the safety and efficacy of a device of a single brand in performing     percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and     stents) in selected patients.   "
126256|NCT01632488|"     The study aims to:        1. Determine whether the density of epithelial gaps in terminal ileum of patients with          irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease          (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).        2. Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and          visceral hypersensitivity.   "
126257|NCT01632475|"     This is a long term follow-up study of the open label, single-center, phase I clinical trial     to evaluate the safety of Pneumostem® in premature infants with BPD.   "
126258|NCT01632462|"     Background VSL#3 has been reported as an effective adjuvant therapy both in inducing and     maintaining remission in pediatric patients affected by Ulcerative Colitis. In addition, it     has been shown that VSL#3 is able to modulates barrier function, intestinal permeability, and     innate host functions, which if altered, could have a profound impact on the state of     colitis. However it is still unclear how VSL#3-induced changes in microbial composition     affect the status of intestinal inflammation and no study have investigated the efficacy of     VSL#3 in the maintenance of remission in pediatric patients with Crohn's disease (CD).      Objectives The purpose of this study will be to evaluate the effect of a probiotic     formulation, VSL#3, versus placebo, on metabolic profile, intestinal permeability,     microbiota, cytokines and chemokines expression in pediatric patients with CD in remission of     disease. In addition, the efficacy of VSL#3 on the maintenance of remission will be assessed     and the safety and the tolerability of the probiotic formula will be evaluated.      Methods This investigation will be a prospective, multicenter, randomized, double-blind,     placebo-controlled, cross-over trial. The study will include 50 children affected by CD in     remission of disease, as defined by a PCDAI < 10, under treatment with Azathioprine     associated or not to 5-ASA and will be articulated in 6 months as follows. All children will     be randomised to a treatment group receiving for 2 months either 1-2 packet containing 900     billion bacteria/day of VSL#3 according to their weight, and a group receiving the placebo     drug. Assignment to therapy or placebo will be determined according to a computer-generated     randomization scheme. At the completion of the 8 weeks, a wash-out period of 6 weeks will     be done, when no preparation will be administered. Then each patient will be switched to the     other group and followed likewise for further 8 weeks. All patients will continue regular     medications throughout the study period. A group of 10 volunteer healthy children, comparable     in age and sex, will be used as reference group for the analysis of metabolic profile.     Patients will be assessed clinically at baseline and every 8 weeks until the completion of     the study, at 24 weeks or at the time of relapse. At every visit data will be collected     including patient questionnaires regarding disease activity (stool frequency, stool     consistency, hematochezia, abdominal pain, extraintestinal manifestations of disease, and     overall patient functioning). Additional information collected at the first visit included     demographic data, family history, and symptom onset. Physical examination will be performed     at each visit by a paediatrician and included an abdominal examination and examination for     extraintestinal manifestations of CD. Routine blood tests for CD, cellobiose/mannitol small     intestinal permeability study, stool cultures, stool calprotectin, will be performed at every     visit and/or at the time of relapse. Urine will be collected for the analysis of metabolic     profile with mono and bi-dimensional high-resolution 1H NMR spectroscopy. PCDAI and a     physician's global assessment will be used to measure disease activity. At baseline and at 24     weeks the patients will undergo ileocolonoscopy to evaluate and endoscopic and histological     activity of disease. Evaluation of microbiota on biopsies and stool samples will be performed     at the time of ileocolonoscopies using Fluorescence In Situ Hybridization. Colon biopsies     cultures will be performed in order to evaluate cytokines and chemokines patterns by     multiplex assay. Additional data will be collected during the study regarding the safety and     tolerability of therapy with VSL #3. Statistical analysis will be performed using SPSS     version 15 (SPSS Inc, Chicago, Illinois, USA). Variables will be screened for their     distribution and appropriate parametric or non parametric tests will be adopted as required.     Cross-tabulations will be evaluated by using the Fisher test and χ2test. Statistical     significance will be predetermined as P < 0.05.      Expected results The investigators expect to find profound alterations in metabolic profiles,     intestinal permeability, microbiota, cytokines and chemokine patterns of patients affected by     CD. The administration of VSL#3 is expected to ameliorate all these alterations eventually     identified. From a clinical point of view the effects of VSL#3 could be translated in     prolonged clinical remission maintenance, offering a new therapeutic tool in the treatment of     CD.   "
126259|NCT01632449|"     This is an single-blind, single-center, two-period crossover, PK profile study. Each subject     will be randomized to one of two treatment sequences. Both treatment sequences will be     enrolled concurrently.   "
126260|NCT01632436|"     This study will be conducted in patients with metastatic cancer and either moderate, severe,     or no hepatic impairment who have failed other antineoplastic therapies or for whom there is     no standard therapy. The study will be conducted in two stages. Using an existing pixantrone     population pharmacokinetic (PPK) model, a model-based strategy will be used to evaluate the     findings from the first stage of the study conducted in patients with moderate hepatic     impairment and matched controls. The PPK evaluation will be completed prior to enrolling     patients with severe hepatic impairment and additional matched controls during the second     stage of the study. Patients with hepatic impairment will be paired with matched control     patients with normal hepatic function, matched on gender, age, and body surface area (BSA).   "
126261|NCT01632423|"     This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice     for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).   "
126262|NCT01632410|"     The study describes the autonomic control system function in subjects post stroke in     comparison with healthy subjects.      Aims: To describe the Autonomic hart rate control system function in post stroke subjects in     different rehabilitation levels in comparison with healthy subjects.      To examine the reflective reaction of the autonomic control system as reflected in the heart     rate variability to stimulations subjects in different rehabilitation levels in comparison     with healthy subjects.      To examine the autonomic control system reaction as reflected in the heart rate variability     to physical and cognitive action subjects in different rehabilitation levels in comparison     with healthy subjects.   "
126263|NCT01632397|"     Following formative work, the proposed study is an open-label, pilot, randomized, two arm     trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a     cognitive-behavioral based adherence intervention or health education with supportive     counseling.   "
126264|NCT01632384|"     The purpose of this study is to see how the brain differs between smoking regularly and after     not smoking for 24 hours. The investigators will be using an MRI machine to get the     information from adult smokers and non-smokers while they lie in the scanner with their eyes     closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after     smoking. It is our hypothesis that brain activity will be altered after not smoking for 24     hours.   "
126265|NCT01632371|"     The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated     balloon (PCB) is superior to PCB alone for the treatment of restenosis within limus-eluting     stents (LES)   "
126266|NCT01632358|"     The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients     with dyslipidemia.   "
126267|NCT01632345|"     Part 1 - Dose-Ranging. Part 1 will evaluate the (1) safety and tolerability and (2) efficacy     (antiretroviral activity) of 4 doses of doravirine (MK-1439) compared with efavirenz, when     each is given in combination with TRUVADA® for at least 24 weeks in approximately 200     participants. A single dose of doravirine will be selected for further study after all     participants complete the Week 24 visit in Part 1. Participants receiving any dose of     doravirine in Part 1 will be switched to the selected doravirine dose and continue in the     study for up to 96 weeks.      Part 2 - Selected Dose. Part 2 will be initiated after the doravirine dose has been selected     as indicated above for Part 1. Approximately 120 additional participants will be randomized     in 1:1 ratio to the selected dose of doravirine or efavirenz, each in combination with     TRUVADA® for 96 weeks of blinded treatment. Part 2 will evaluate the safety of the selected     dose compared with efavirenz, particularly with regard to central nervous system adverse     events (CNS events).      The hypothesis tested in this study is that MK-1439 at the final dose selected is superior to     efavirenz, each given in combination with TRUVADA®, as measured by the proportion of     participants with CNS events by Week 8. If superiority is established at Week 8, the same     hypothesis will be tested for Week 24.   "
126268|NCT01632332|"     The purpose of this study is to look at the safety and immune response to a vaccine used in     patients previously treated for HER2 (human epidermal growth factor receptor 2) positive     breast cancer.   "
126269|NCT01632319|"     The purpose of this study is to investigate the effectiveness of 2 different therapy courses     for undergraduate college students who binge drink and experience depressive symptoms.   "
126270|NCT01632306|"     Purpose of this phase I/II study is to test how well LY2090314 works in combination with     different chemotherapies in treating participants with metastatic pancreatic cancer.   "
126271|NCT01632293|"     The purpose is to see how multiple sclerosis (MS) is associated with strength and sensation     using MRI, in persons with MS. The investigators will also see whether exercise can improve     these symptoms for persons with MS.   "
126761|NCT01625871|"     The cure rate of artemether/lumefantrine in the treatment of vivax malaria.   "
126273|NCT01632267|"     Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients     achieve remission following an initial antidepressant trial. The financial burden of     treatment failures in direct treatment costs, disability, decreased productivity, and missed     work may in part derive from a mismatch between optimal, and actual, medications prescribed.     The present one year retrospective study seeks to evaluate the indirect and direct healthcare     costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an     interpretive reporting system designed to predict antidepressant responses based on DNA     variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene     (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.   "
126274|NCT01632254|"     The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify     the plaque composition and lipid content of plaques and will have the potential for repeated     in vivo measurements. To investigate sensitivity and specificity of 3.0 Tesla MRI and MRS for     dimension and composition assessment of carotid artery plaques, in particularly those plaques     with lipid rich necrotic cores. This non-invasive cross-sectional study, compares carotid     parameters of in-vivo 3.0 Tesla MRI, MRS and B-mode ultrasound with histology specimens     collected at endarterectomy.   "
126275|NCT01632241|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab     in adult patients of black race with systemic lupus erythematosus (SLE; lupus).   "
126276|NCT01632228|"     This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate     the safety and efficacy of onartuzumab in combination with bevacizumab as compared to     bevacizumab alone in participants with recurrent glioblastoma. Participants will be     randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus     bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity,     participants or physician decision to discontinue, or death.   "
126277|NCT01632215|"     The purpose of this study was to evaluate the postoperative analgesic effect of preoperative     gabapentine for carpal tunnel syndrome surgery.   "
126278|NCT01632202|"     Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates     opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue     while the normal tissue repair process takes place. When used in the abdominopelvic cavity,     it has been shown to reduce the incidence of adhesions.      The intrauterine cavity is a potential space where the walls of the uterus are collapsed upon     itself in the normal state. It has been demonstrated that the trauma of removing a submucosal     fibroid with electrocautery exposes the uterus to great potential for intrauterine adhesions     since the raw charred surface is directly opposed to the opposite endometrial surface.     Previous studies have shown that the placement of hyaluronic acid in the intrauterine cavity     after a myomectomy is not only safe, but also decreases the incidence of intrauterine     adhesions.      The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine     cavity and creating a temporary physical barrier between the walls of the uterus, that they     will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48     hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one     week, the investigators anticipate that the patient will have minimal to no discomfort; since     no physical device is being left in the endometrial cavity, the uterus will not be     contracting more than it does in its normal postoperative state.   "
126279|NCT01632189|"     This study will evaluate effects of treatment with varenicline, a smoking cessation drug, on     the dopaminergic system by using Positron Emission Tomography (PET) imaging with new     radioligand, [11C]-(+)-PHNO. The investigators primary hypothesis is that chronic varenicline     administration will increase dopamine (DA) receptors levels ([11C](+)PHNO) within the human     brain.   "
126280|NCT01632176|"     This randomized controlled trial (RCT) study is a small scale test of the feasibility and     preliminary efficacy of a brief motivational interview-style intervention. The intervention     took place in the pediatric emergency departments by a trained interventionist and will     followed an intervention algorithm developed by a team of dating abuse and brief intervention     experts. The research design is as follows: the investigators will randomize youth ages 12-19     years old to one of two groups: one group who receives the intervention (N=~18), and the     other which does not (N=~18). The investigators compared changes in outcomes from baseline to     1-month follow-up for those in both groups. The investigators looked at outcomes including     dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and     dating abuse behavior (perpetration and/or victimization).      Statement of study hypothesis: Youth who receive the intervention will show improvements in     dating abuse-related knowledge, attitudes and behavior that are maintained for 1 month, while     those in the comparison group will show no similar change.   "
126281|NCT01632163|"     Primary Objective:      - To assess the effects on glycemic control of lixisenatide in comparison to placebo as an     add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over     a period of 24 weeks in insufficiently controlled type 2 diabetic patients.      Secondary Objectives:        -  To assess the effects of lixisenatide over 24 weeks on :             -  percentage of patients reaching HbA1c<7% or ≤6.5%,             -  2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during               standardized meal challenge test,             -  fasting plasma glucose (FPG),             -  change in 7-point self-monitored plasma glucose (SMPG) profile),             -  body weight,             -  change in daily basal insulin dose.        -  To assess lixisenatide safety and tolerability.        -  To assess anti-lixisenatide antibody development.   "
126282|NCT01632150|"     The purpose of this study is to determine the safety and tolerability of elotuzumab     administered in combination with thalidomide and dexamethasone in the treatment of relapsed     and/or refractory multiple myeloma.   "
126283|NCT01632137|"     The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic     suspension in subjects with dry eye syndrome.   "
126284|NCT01632124|"     Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab     in patients with rheumatoid arthritis or inflammatory myositis.   "
126342|NCT01631357|"     This randomized, open-label phase II/III study is to evaluate the effects of chemotherapy     combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage     IIIb-IV squamous non-small-cell lung cancer   "
126285|NCT01632111|"     The objective of this study is to investigate whether Agalsidase alpha, a drug commonly     prescribed in patients with Fabry disease, is associated with improvement of the pulmonary     involvement. According to the Global Initiative for Obstructive Lung Disease (GOLD), the     surrogate markers for obstructive lung diseases are a decrease in both forced expiratory     volume in one second (FEV1) and FEV1/FVC ratio, whereas FVC is the forced vital capacity.     However, the measurement of these lung function parameters is indicated as yearly follow-up     examinations with or without the treatment of Agalsidase alpha in patients with Fabry     disease.   "
126286|NCT01632098|"     Obesity is one of the biggest public health challenges today and in the years to come,     particularly due to its rising prevalence in children and adolescents. In addition to the     increased health risks for each individual, obesity causes a tremendous economic burden on     the healthcare system.      Here, the investigators will examine the impact of extreme obesity on healthcare utilization,     costs, and health related quality of life in adolescents. The study is a subproject of the     Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects     of structured care study, short: Youth with Extreme obesity Study (YES), which aims at     improving the medical care and social support structures for youth with obesity and extreme     obesity in Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and     24.9 years (initially up to 21 years) are eligible to participate. Participants will complete     questionnaires to assess health related quality of life and utilization of healthcare. These     questionnaires will be applied at baseline and then every 12 months (initially every 6     months) during health check-ups. As part of the other subprojects of YES, participants will     be invited to complete further questionnaires and will be offered a thorough medical     examination, medical care and psycho-social support.      The investigators expect to provide valid and up-to-date information on costs and     health-related quality of life for obese adolescents. This information will help in the     planning of useful and cost effective preventive and therapeutic strategies, and improve the     medical care and support structures for obese adolescents.   "
126287|NCT01632085|"     Reduce the risk of nosocomial transmission of germs related to the reusability of the     laryngoscope handle. The alternative is to replace it with a disposable device, provided that     it is as effective as the reference strategy at a reasonable cost.   "
126288|NCT01632072|"     The purpose of this study is to determine whether a nutrition intervention during a     rehabilitation stay followed by nutritional advice after discharge, can improve the     nutritional status of the patients after 3 months.   "
126289|NCT01632059|"     Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine     Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as     prognostic value.      This study looks into ADMA as a good prognostic factor for sepsis. Further more the     dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.   "
126290|NCT01632046|"     Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage renal     disease. Unfortunately progressive alterations of the peritoneal membrane occur with time on     PD, leading to a continuous loss of peritoneal transport function. Recently, double-chambered     PD solutions with less Glucose Degradation Products (GDPs) and neutral pH have been approved     for the European market. Short term administration suggests comparable clearance rates     compared with conventional solutions. In vitro studies demonstrate an improved local immune     defense system. To compensate for metabolic acidosis, the available solutions either contain     lactate or bicarbonate, the impact of either buffer on long term acidosis control and     peritoneal membrane integrity, however, is unknown.      The prospective, European multi-center study will provide the first long term administration     of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a     bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end     point will be the effect of either PD-solution on peritoneal transport characteristics (D/P     Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base     balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate     parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants     of the peritoneal transporter status and of the continued morphological transformation of the     peritoneum will be assessed.      After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution,     the patients will be randomized to a 10 month study period using BicaVera and Balance,     respectively. Dialysis regime and follow up in the out-patient clinic will be performed     according to clinical needs (every 4 weeks); episodes of peritonitis will be treated     according to international guidelines. Bicarbonate supplements will be prescribed at a dose     of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be     verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5 ml     of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after 3,     6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test an     intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be obtained     at any time of abdominal surgery. Adverse events will be screened meticulously. The trial     will be carried out in accordance with the German medicines act (AMG) and other local     requirements, with particular reference to the ICH guidelines for Good Clinical Practice, and     the declaration of Helsinki. At study end, the patients will decide together with the     responsible physician which PD-fluid should be used further one.   "
126291|NCT01632033|"     The purpose of this study is to test the routine faisibility of a questionnaire to estimate     walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.   "
126292|NCT01632020|"     The purpose of this study is to investigate the effects of short term oral Metformin therapy     on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal     adenocarcinoma.      It is hypothesized that there are independent actions of Metformin on the outcome of subjects     with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth     will correlate with this drug's effects on markers mentioned above, because the markers are     closely related to tumor growth and metastases.   "
126293|NCT01632007|"     The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in     diabetic patients.   "
126294|NCT01631994|"     Summary:      This study investigates the use of oral dissolving metoclopramide during standard video     capsule endoscopy. Metoclopramide is a pro -motility agent, that is, this medication helps     with movement through the stomach and small bowel. This study will help us determine the     effectiveness of oral dissolving metoclopramide on transit time through the stomach and small     bowel of the video capsule that is ingested. This study may help with better diagnoses of     pathology in the small bowel. Each patient enrolled in the study will either be assigned to a     group that only ingests the capsule or the group that receives the oral dissolving     metoclopramide plus capsule. Each patient will undergo the same standard procedures and     precaution used during standard video capsule endoscopy. The patients that will qualify for     the study are patients that are in need of video capsule endoscopy for further imaging of the     small bowel. The patients must meet the inclusion criteria provided in the protocol and must     not meet any of the exclusion criteria in the protocol. The hypothesis is that the patients     that ingest the metoclopramide will have better capsule images and transit time and will     allow for enhanced diagnosis of small bowel pathology.   "
126295|NCT01631981|"     This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo     controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics     of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration     for the treatment of pain symptoms suggestive of endometriosis. The target population will be     women of reproductive age with symptoms suggestive of endometriosis.   "
126296|NCT01631968|"     Prospective randomized study in cemented primary total knee arthroplasty. In one group the     cement used was standard cement, without any antibiotics and in the other group the cement     used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement.     In all cases intravenous antibiotics prophylaxis against infection was used. In both groups     the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in     all cases. The main variable was the presence of infection according to the Center of Disease     Control criteria with a minimum of 12 months follow-up.   "
126377|NCT01630902|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan     Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were     separated by a washout period of 21 days during fasting study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
126297|NCT01631955|"     Although Cystitis includes a clinical syndrome characterized by various combinations of     dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or     abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI     (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been     little research on Clinical aspects on cystitis treatment such as bothersomeness, or the     impact of symptoms on patients' quality of life (QoL). The investigators want to study for     Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay)     in Acute Uncomplicated Cystitis in Korean Women.   "
126298|NCT01631942|"     This trial is conducted in Europe. The aim of this trial is to investigate safety,     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the     effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to     healthy male subjects and subjects with haemophilia.   "
126299|NCT01631929|"     This is a randomized controlled trial comparing the time needed to get the conditions to     space hourly controls to controls every 4 hours, using the one bag system versus the two bags     system, in the initial treatment of children with diabetic ketoacidosis. After fast infusion     of isotonic saline solution (20 ml/kg) to prevent shock, the administration of maintenance     fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose controls could     determine changes in glucose IV administration. On using the classic one bag system each     change determine a bag change. Using the two bag system allows to deliver the patient the     appropriate glucose infusion in less time.   "
126300|NCT01631916|"     The purpose of this study is to determine the efficacy of addition of corticosteroid therapy     to antibiotics in children hospitalized with community-acquired pneumonia.      The hypothesis is that the use of corticosteroids decreases the length of stay in children     hospitalized with community-acquired pneumonia.   "
126301|NCT01631903|"     The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four     doses of vaginally administered Proellex in premenopausal women with uterine fibroids     confirmed by ultrasound.   "
126302|NCT01631890|"     Consecutive patients who meet the eligibility criteria will be enrolled into the study. All     patients with gastric varices with no history of gastric variceal bleed (Group C) will     undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end of     first year and at the end of study.      The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal     bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group -A     (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound     followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90     patients will be enrolled and randomized into group A and Group B after resuscitation and     urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices to     achieve hemostasis.   "
126303|NCT01631877|"     After successful screening the cases of cirrhosis of liver irrespective of the etiology who     have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will     be recorded and the patient will be randomized into either interventional (acenocoumarol) or     placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj.     Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3     monthly the Doppler screening for recanalization of portal vein thrombus will be done with     monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will     receive the therapy for one year irrespective of the Doppler findings in relation to portal     vein thrombus re-canalization.Then one year drug free monitoring will be done in both the     groups as per the primary or secondary outcome. .   "
126304|NCT01631864|"     This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and     oxidative metabolism in obese hypertensive subjects.   "
126305|NCT01631851|"     In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder     (ASD) often exhibit disruptive behavior problems including irritability, tantrums,     noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also     known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches     children to recognize antecedents and consequences of problem behavior and to use emotion     regulation and problem-solving skills to reduce irritability, aggression and noncompliance.     This form of CBT has been well-studied in typically developing children with disruptive     behavior and we are investigating if this treatment can be feasible and helpful, with     appropriate modifications, for irritability and disruptive behavior in ASD.   "
126306|NCT01631838|"     The objective of this study is to address the anti-thrombotic effects of tocotrienols     supplementation via modulation of platelet activation, thrombotic markers, inflammatory     markers and endothelial function.      It is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress     platelet aggregation in subjects with metabolic syndrome.   "
126307|NCT01631825|"     -  To investigate the safety of once-daily repeated transdermal administration of SPM 962          within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's          disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label          uncontrolled study.        -  To investigate efficacy of SPM 962 in an exploratory manner.   "
126308|NCT01631812|"     The primary objective of this study is to investigate safety of SPM 962 in advanced PD     patients in a multi-center, open-label, non-controlled study following once-daily multiple     transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54     weeks). Efficacy is also to be exploratory investigated.   "
126309|NCT01631799|"     Total knee replacement is very common in Germany. After surgery patients have severe pain in     the knee; initiation of the physiotherapy, however, is important in the first three days     after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are     commonly used after surgery. Both methods are used in Germany. Both methods have advantages     and disadvantages. We wanted to answer the question which method of analgesia - after total     knee replacement - is better concerning complications and function (after 3 months) ?   "
126378|NCT01630889|"     The purpose of this open-label extension study is to evaluate long-term efficacy and safety     of FG-4592 in maintaining hemoglobin in dialysis and non-dialysis CKD patients who have     completed the Treatment Period of an FG-4592 FibroGen-sponsored anemia study.   "
126310|NCT01631786|"     Ultrasonography is currently the most common diagnostic tool for imaging the female     reproductive tissues. However, clinical ultrasonography is limited to the detection of     ovarian structures ≥ 2 mm, with an inability to image microanatomy including small antral     follicles and oocytes. The objective of this study is to determine whether the synchrotron     can be used to effectively image bovine and human ovaries ex situ. We hypothesize that     synchrotron imaging will provide greater resolution and thereby allow the detection of fine     structural details of the ovary compared to conventional ultrasonography. Ovaries will be     imaged using conventional ultrasonography, synchrotron and histology. We anticipate that our     results will provide important information about ovarian physiology which can be applied to     the study of female reproductive dysfunctions.   "
126311|NCT01631773|"     We hypothesize that the miRNA expression in subjects with nasal polyps and     Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects     with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).   "
126312|NCT01631760|"     We hypothesize that there is a statistically significant difference in miRNA profiling and     expression of subjects with asthma upon its exacerbation compared to patient's baseline level     or following effective treatment of an exacerbation of asthma. Therefore, plasma miRNA     profiling may provide noninvasive, highly specific and sensitive biomarkers for asthma     exacerbation's detection and treatment follow-up.   "
126313|NCT01631747|"     The prevalence of maternal overweight and obesity has nearly doubled in the United States     since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23%     in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within     certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal     and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse     OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain     (GWG) through recommended diet, activity and lifestyle changes that are to be maintained     postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic     (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and     behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be     measured for length, weight and percent body fat. The goal is to limit excessive gestational     weight gain through improved maternal lifestyle that can be maintained and modelled for the     family post partum and beyond.   "
126314|NCT01631721|"     The purpose of this study is to understand the factors that lead to adolescent sexual risk     behavior by investigating both the family contexts and romantic relationships that influence     adolescent couples' decision-making.   "
126315|NCT01631708|"     Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten     life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to     maintain normal iron levels. It is unclear, however, whether treatment is necessary when     individuals have moderate elevation of iron in the body. This research project will study the     effects of treatment in this group by assessing a number of scans, questionnaires and blood     tests in treated and untreated individuals.   "
126316|NCT01631695|"     In this study, the performances of Medasense's non-invasive pain monitoring is compared with     standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with     a subjective pain level assessment. The subjective pain level is assessed by the     anesthesiologist when the patient is under general anesthesia and by the patient and a nurse     in post anesthetic care unit (PACU).      The study is based on recording and analyzing the subject's physiological signals, while     recording painful events, medication dosing and different clinical signs.   "
126317|NCT01631682|"     The aim of this project is to create fear conditioning paradigm within which the relative     strengths of various novel pharmacological and behavioral interventions can be tested. These     interventions are intended to reduce the fearfulness associated with fear conditioning by     blocking a memory process known as reconsolidation. In fear conditioning, a conditioned     stimulus (CS) is paired with an aversive unconditioned stimulus (US) such as an electric     shock, until presentation of the CS alone comes to elicit a fear conditioned response (CR).     The investigators hypothesize that by using a more highly prepared CS (i.e. video of     spiders); more sensitive subjects (individuals with stronger acquired CRs); and additional     experimental probes for the presence of the latent CR, the investigators may develop a normal     human paradigm that is not plagued by previously observed floor effects (i.e. intervention is     100% effective), within which both the established techniques of propranolol and delayed     extinction will produce significant, but only partial, CR reduction. This would leave room to     test and compare potentially more powerful candidate reconsolidation-blocking or     memory-updating interventions. To achieve these aims, subjects will undergo a four-day fear     conditioning and delayed extinction protocol. Skin conductance response data will be gathered     across the different phases of the experiment.   "
126318|NCT01631669|"     Hypotheses:      H1: Celecoxib, when given less than five days after injury will result in a statistical     decrease in the incidence and/or severity of radiographically apparent Heterotopic     Ossification when compared to controls.      H2a: A biomarker profile will accurately predict which patients in the treatment group will     respond to Celecoxib prophylaxis for Heterotopic Ossification.      H2b: A biomarker profile will accurately predict which patients in the control group are at     highest risk of developing Heterotopic Ossification   "
126319|NCT01631656|"     The purpose of this study is to compare efficacy and outcomes of treatment with azelaic acid     (Finacea Gel) and Vascular ND:Yag laser therapy versus Vascular ND:Yag laser therapy alone     via a split face study design in approximately ten to fifteen subjects with mild to moderate     rosacea.      We hypothesize that treatment of rosacea with combination azelaic acid (Finacea Gel) and     Vascular ND:Yag laser therapy will lead to a greater improvement in lesion count, redness and     telangiectasias compared to treatment with Vascular ND: Yag laser therapy alone.   "
126320|NCT01631643|"     Evaluation of the clinical benefits of One Touch VerioIQ system.   "
126379|NCT01630876|"     This study compares the anatomical and visual outcomes of patients with idiopathic epiretinal     membrane(ERM) treated by vitrectomy and membrane peeling with or without subtenon     triamcinolone acetonide injection   "
126380|NCT01630863|"     To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment     of central serous chorioretinopathy.   "
126321|NCT01631630|"     Background:      - Drinking too much alcohol can injure cells in the body. Inflammation is the body s reaction     to injured cells. Studies show that inflammation can cause cravings for alcohol. Researchers     want to see if pioglitazone, a drug that decreases inflammation, can reduce alcohol craving.     If so, it might help develop new ways to help alcoholics with craving.      Objectives:      - To see if pioglitazone can reduce alcohol craving.      Eligibility:      - Adults between 21 and 65 years of age who are alcoholic and have been drinking within the     past month.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will also be collected.        -  All participants will have inpatient treatment at the National Institutes of Health          Clinical Center for the 5 weeks of the study. They will have standard treatment for          alcoholism during their inpatient stay.        -  Half of the people in this study will have pioglitazone. The other half will have a          placebo.        -  Participants will have different studies during their stay. These studies will include          the following:        -  Personalized audio recordings of stressful, alcohol-related, and neutral events to          monitor mood        -  Imaging studies to test alcohol cravings        -  Questionnaires about mood and alcohol cravings        -  Lumbar puncture to collect spinal fluid        -  Inflammation test to see if the study drug can block alcohol cravings        -  After the end of the 5-week study, all participants will be offered follow-up outpatient          care through the Clinical Center, or referral to outside treatment.   "
126322|NCT01631617|"     Background:      - Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have     infections with S. aureus bacteria. Researchers want to study how eczema treatments affect     the number and the type of bacteria on the skin.      Objectives:      - To study the effect of eczema treatments on skin bacteria.      Eligibility:        -  Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis.        -  Healthy volunteers between 18 and 40 years of age with no history of eczema.      Design:        -  Participants will be screened with a physical exam and medical history. Research samples          will be collected. Skin biopsies may also be performed.        -  All participants will be assigned to one of several study groups.        -  This study will last for up to 1 year. Healthy volunteers must not have taken          antibiotics in the year before the start of the study.        -  All participants will have regular study visits during their 1-year participation. More          research samples will be collected at these visits.   "
126323|NCT01631604|"     The purpose of this study is to quantify the safety degree of the patient's gait, to detect     the reason for the fall and quantify the biomechanical parameters related to fall. This study     also aims to evaluate the effect of different rehabilitation treatments and their effect on     the risk of falling.   "
126324|NCT01631591|"     Eosinophilic esophagitis is characterized by an eosinophilic infiltration of the esophagus.     It presents clinically with a variety of symptoms including dysphagia, emesis, and food     impaction. Although the underlying mechanism is different, gastroesophageal reflux can     present with similar clinical findings but can be distinguished from eosinophilic esophagitis     by the number of eosinophils present on esophageal biopsy. In children, food allergies play a     role in exacerbating eosinophilic esophagitis, but the role of food allergies in adults is     uncertain. In this study, we aim to determine the prevalence of food allergies in a cohort of     adults with eosinophilic esophagitis.   "
126325|NCT01631578|"     A prospective randomized controlled trial (RCT) to determine the effect of injecting an     autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into     oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.   "
126326|NCT01631565|"     There is recent evidence that early palliative care administered to patients helps for their     quality of life (QoL). It is however not part of the standard multidisciplinary treatment.      This study intents to evaluate the effect of early palliative care in patients with advanced     Non-Small Cell Lung Cancer (NSCLC) compared to the standard of care.   "
126327|NCT01631552|"     The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single     agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated     patients with advanced epithelial cancer.The secondary objectives are to obtain initial data     concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132     targets the TROP-2 antigen which is expressed on a variety of cancers. The antibody, RS7, is     attached to SN38, which is the active metabolite of irinotecan. This is planned as a     multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast     cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up     to 50 patients (assessable) per other cancer types included in the protocol will be studied     at the 10 mg/kg dose.   "
126328|NCT01631539|"     The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded     with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for     wildtype KRAS unresectable liver metastases from colorectal cancer.   "
126329|NCT01631526|"     Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse     clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes     prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention     using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin     D concentrations of every patient well into the normal range (> 100 nmol/L) within 2 or 3     weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data     will also be obtained to identify potentially clinical important outcome benefits for future     investigation. The outcomes are        1. plasma 25OHD concentration        2. Vitamin D binding protein and other plasma concentrations        3. Mood and symptom   "
126330|NCT01631513|"     The purpose of this study is to evaluate tapentadol Extended Release (ER) in the treatment of     moderate to severe chronic pain in participants with a diagnosis of chronic low back pain     (LBP) or osteoarthritis (OA) of the hip or knee after conversion from hydrocodone, oxycodone     Controlled Release (CR), and/or morphine Sustained Release (SR).   "
126381|NCT01630850|"     The purpose of this study is to learn about the safety of islet transplantation for Type 1     diabetes mellitus, which may provide more normal control of blood sugar without the need for     insulin shots. Islets are special clusters of cells within the pancreas that produce insulin.     These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.   "
126331|NCT01631500|"     Minor mental health problems, MMHP, like mild depression and anxiety, and medically     unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly     associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead     to impaired social and cognitive function and could result in reduced work capacity. The     investigators have designed the present study as a pragmatic trial to investigate the     effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional     treatment in patients with MMHP or MUS in primary care. The investigators examined whether     the effects of the integrative treatment model differed from those achieved with therapeutic     acupuncture or conventional treatment. Primary endpoints were anxiety and depression     (assessed with the Hospital Anxiety and Depression scale), health-related quality of life     (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment     interventions.      Statistical power was calculated based on an expected 50% reduction in HAD anxiety and     depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture;     and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83%     at p <0.05. Treatment effects were calculated as the difference between values at baseline,     after four weeks and after the complete intervention period, i.e. after eight weeks.     Nonparametric analyses were carried out to test differences between independent samples     (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).   "
126332|NCT01631487|"     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of     JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in     healthy Japanese adult male participants in Part 2.   "
126333|NCT01631474|"     CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent     skin disorder. The purpose of this study is to compare the safety and efficacy of multiple     concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.   "
126334|NCT01631461|"     The aim of this study is to investigate the prevalence of yeast and bacteria in women with     breastfeeding pain and to identify signs and symptoms.   "
126335|NCT01631448|"     Globally there have been about 45,000 kidney transplants last year. Currently, the overall     survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major     challenge to overcome by the renal transplant surgeons, are surgical complications which may     impact on patient morbidity and mortality, as well as graft function.      The aim of the study is to assess whether application of fibrin seal prevents postoperative     complications in patients undergoing kidney transplantation.      Controlled clinical trial with single-blind evaluation in patients surgically intervened     kidney transplantation. It will include all patients undergoing renal transplantation in this     Medical Center, any gender and over than 16 years and under 60 years.   "
126336|NCT01631435|"     This is a prospective, multi-center (up to 6 sites) study which aims to To establish the     effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by     visualizing the small bowel and colon in patients with active symptoms associated with     Crohn's disease (CD).   "
126337|NCT01631422|"     This single-center, open-label study will investigate the pharmacokinetics and elimination of     a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers     will receive a single oral dose of RO4602522.   "
126338|NCT01631409|"     This study is dedicated to determination of the long term effectiveness of coronary heart     disease (CHD) treatments - cardiac shock wave therapy (CSWT) in comparison with other kinds     of medical and surgical treatment. For that purpose the investigators will observe the     patients with CHD who enrolled in this study in their routine course of treatment. But the     investigators will not interfere with the patient treatment. Each participant will be     followed-up for five years. The collected data will allow to determine if the particular     method, CSWT, could really make any additional contribution to the more traditional methods     of CHD treatment and if the CSWT is only temporarily effective or could exert the long term     effect as well.   "
126339|NCT01631396|"     The study is a prospective, single center, double arm study aiming at the comparison of 2     commercial neuromuscular block reversal drugs: Neostigmine (Cooper S.A.) and Sugammadex     (MSD). A faster recovery from neuromuscular block is expected for patients receiving     Sugammadex and this protocol is of high importance for anesthesia of morbid obese patients     during bariatric surgery.   "
126340|NCT01631383|"     This study will test the safety and pharmacokinetic profile of l-THP with cocaine exposure in     people who have a history of cocaine use. The subject will be admitted to the Brief Stay Unit     (BSU), an inpatient facility at the Maryland Psychiatric Research Center, used for short term     drug abuse or clinical trial studies. The participant will stay for 4 nights and 5 days.     He/she will be randomized to either placebo or l-THP for three days. On the morning of Day 4,     the subject will receive one cocaine dose (40 mg intranasal) and have testing for     pharmacokinetic parameters for the following 10 hours. The subject will stay over one more     night and will be discharged the following day. Approximately 40 subjects will be randomized     to enroll the target sample of 30 (N=15 placebo, N=15 l-THP). In summary, each subject will     come for a screening visit(s), then a 5-day, 4-night stay on a secure research unit. After     cocaine administration day, the participant will stay overnight for one more day of     observation and to permit substantial l-THP elimination from the body. The following morning     we will get one additional blood specimen for l-THP (Day 5 at 24 hours after last dose (7:30     am); then the participant will be discharged. A visit with blood collection on Day 6 at 55     hours after last dose (2:30 pm) will be scheduled. A final follow-up visit will be scheduled     4-7 days after unit discharge to ensure no persisting side effects.   "
126341|NCT01631370|"     Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity     also induces insulin resistance and it could therefore be assumed that a renal denervation     might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in     patients with treatment resistant essential hypertension both 1 and 3 months after renal     denervation compared to a control group with treatment resistant essential hypertension.     Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance     assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on     insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to     investigate the degree of insulin resistance in muscle, liver and adipose tissue.   "
126343|NCT01631344|"     Background:      Low back pain is the leading cause of disability, affecting the quality of life and work     productivity.      It is the most common reason for seek medical help and advice. Low back pain creates huge     economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically     defined with no preferred medical treatment        1. Study objectives:           To prove that consulting using the Stage of change model for daily physical activity          will lead to long term improvement of pain, disability and well-being parameters of          those suffering from chronic low back pain, people age 25-55, when compared to          conventional Physical Therapy.        2. Study hypotheses:           The intervention groups vs. Physical Therapy group will demonstrate that the following          parameters will improve after: 3 months, one, two and five years.             1. Pain reduction.             2. Less disability - improvement in daily activities.             3. Better feeling of health and well-being.             4. Increased and better compliance to daily sport activities.             5. BMI reduction.             6. Reduction of cigarette smoking.             7. Reduction of usage of anti-analgesics and anti-inflammatory medications.             8. Reduction in number of visits to Physical Therapy clinics due to low back pain.        3. Methods:      The present Randomized intervention study that will include 220 healthy individuals, males     and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or     without radiation to the legs that were referred to Maccabi Healthcare Services Physical     Therapy clinics in the Sharon district in Israel.      These individuals will be randomized to one of the following two groups:        1. Conventional Physical Therapy.        2. Physical Therapy focused on healthy lifestyle using the Stage of Change model.      Non-dependent observer will follow-up on the outcome parameters via phone calls and filling     the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5     years.   "
126344|NCT01631331|"     The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell     carcinoma (BCCs) prior to surgical removal.   "
126345|NCT01631318|"     Patients are invited to participate in a research study of liver perfusion (how blood flows     to the liver over time). Researchers hope to learn whether perfusion characteristics of liver     metastases may be predictive of response to treatment and whether liver perfusion     characteristics can be used to follow response to treatment. Patients were selected as a     possible participant in this study because they are identified as having liver metastases   "
126346|NCT01631305|"     The purpose of this study is to determine whether levothyroxine is effective and safe in the     treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive     care unit.   "
126347|NCT01631292|"     In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese     women, and hypothesize that it will not affect areal BMD, but will alter bone compartments     (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum     25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes     include the influence of vitamin D and weight loss on markers of insulin resistance and on     cognitive tests of attention, learning, and memory.   "
126348|NCT01631279|"     The purpose of this study is to determine the Maximum Tolerated Dose and the Dose-Limiting     Toxicity of the drug to further evaluate safety and antitumor activity.   "
126349|NCT01631266|"     Tuberculosis (TB) continues to be the most important bacterial infection worldwide and     therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.      We are investigating a new skin test named C-Tb. Like the current tuberculin skin test (PPD),     the C-Tb test is injected just under the skin and will, when positive, show redness and/or     swelling at the injection site while a negative test will leave no reactions.      The aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are divided     into four groups:        -  Negative control group: Must have no history of exposure to a person with tuberculosis          disease.        -  Occasional contact: Must be in contact with a person with tuberculosis disease between 6          hours/week and 6 hours/day        -  Close contact: Must be in close contact with a person with tuberculosis disease for more          than 6 hours/day for at least five days        -  Positive control group: Must have a confirmed tuberculosis disease within the last 3          years.      The goals of this clinical trial are:        -  To compare the C-Tb test to a blood test, the QuantiFERON test.        -  To compare the C-Tb test to the PPD test that is currently being used.        -  To assess the safety of the C-Tb test.   "
126350|NCT01631253|"     The purpose of this study is to investigate the impact on ovarian reserve after single- port,     two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti     mullerian hormone change.   "
126351|NCT01631240|"     This proposed calibration study is designed to evaluate the correlation of urinary sodium     excretion between NHANES timed urine and 24-hour urine collections.   "
126352|NCT01631227|"     Aim of this study is to compare the blood pressure lowering effect of a new drug formulation     of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide     since years with proven efficacy. The new formulation is compared to the currently marketed     eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be     demonstrated.   "
126353|NCT01631214|"     The purpose of this study is to determine if treatment is effective in preventing fractures     in women with postmenopausal osteoporosis   "
126354|NCT01631201|"     This study will test the safety and effectiveness of an investigational antibiotic drug,     rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This     study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1     gram, which will be given as a single dose to women who have genital chlamydial infection.   "
126355|NCT01631188|"     The study is being done to determine if the Endovent pulmonary catheter kit, used for port     access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that     the Endovent kit can be used effectively as a passageway for a pacing wire system.   "
126356|NCT01631175|"     Aim of this study is to develop and establish an indication-based algorithm for identifying     particular stress patterns of patients with initial diagnosis of a sarcoma or a metastatic     bone disease. A further aim was the establishment of an adequate psychosocial treatment     within the clinical workday routine to support coping with illness and treatment.   "
126357|NCT01631162|"     The investigators assume that by analysis of different volatile organic compounds in the     breath, using nanotechnology, the investigators will be able to identify a unique respiratory     signature of different diseases including asthma, chronic obstructive pulmonary disease     (COPD) and pulmonary hypertension.   "
126382|NCT01630837|"     The purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of     gingival health in patients with an adequate method of oral hygiene.   "
126650|NCT01627314|"     This study is an open-label randomized, prospectively and historically controlled trial of     the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant     following myeloablative or reduced intensity conditioning for subjects age 15-65 years with     hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in     the trial at approximately 10 centers within the U.S.   "
126358|NCT01631149|"     Rationale: A deep neuromuscular block is often associated with improved surgical conditions     especially in laparoscopic surgery. However, a deep block comes at the expense of a variety     of items that may conflict with the use of a deep surgical muscle blockade including a long     recovery phase, the need for muscle reversal, postoperative ventilation, impaired     postoperative breathing. With the introduction of Sugammadex there is now the possibility to     reverse an even deep surgical block. This may overcome most if not all of the issues     mentioned.      Objective: To assess whether a deep neuromuscular block provides better surgical conditions     than a moderately deep block as derived from a surgical rating score.      Study design: Single center, double-blind randomized controlled trial. Study population: 24     ASA I-III patients scheduled for laparoscopic renal (n=12, GROUP 1) or prostatic surgery     (n=12, GROUP 2).      Intervention: In both GROUP 1 and GROUP 2, 6 six patients will receive neuromuscular blockade     according to current practice (atracurium (bolus) plus mivacurium (cont. infusion)) aimed at     a moderately deep neuromuscular block (1-2 twitches in the Train of Four (TOF) monitor). The     other six will receive a bolus plus continuous infusion with rocuronium aimed at a deep     neuromuscular block (1-2 twitches post tetanic count (PTC)). All surgical procedures will be     performed by one surgeon.      Main study parameters/endpoints: To study the surgical conditions in patients undergoing     laparoscopic renal or prostate surgery during deep versus less deep neuromuscular block as     assessed by the surgical rating score.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Compared to current practice there will be no additional risk.   "
126359|NCT01631136|"     In France, lung cancer is responsible for more than 30000 each year. Progress was made in     treatment of lung cancer in the last five years due to targeted therapies and to strategical     evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of     this strategical evolution. It is based on maintaining continuous therapeutical pression in     order to preserve the therapeutical benefit obtained by the first line (induction     chemotherapy). Several clinical trials showed that maintenance strategies increase the     duration of controlled disease.      There is two types of maintenance strategies:        -  Continuous maintenance : prolongation of the treatment initially associated with platin          until progression        -  Switch maintenance : introduction of a new treatment after the end of induction          chemotherapy      The aim of this study is to compare two maintenance strategies        -  A continuous maintenance by pemetrexed        -  A switch maintenance or a continuous maintenance according to the response of induction          chemotherapy.   "
126360|NCT01631123|"     This is an intervention study in healthy adult twins with the aim to investigate the genetic     determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet     versus an isocaloric low carbohydrate, high fat diet.   "
126361|NCT01631110|"     The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills     the EMA requirements for re-registration of influenza vaccines.   "
126362|NCT01631097|"     This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics,     safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of     hepatic impairment and normal hepatic function.   "
126363|NCT01631084|"     In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short)     supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different     sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. After     explanation by trained doctors and nurses, and with written informed consent, patients will     be randomized to either the JADE (n=300, structured care) or DIAMOND (n=300, usual care)     group.      All patients will undergo a comprehensive assessment (CA) at baseline and yearly thereafter.     Patients in the JADE group will be further managed by a doctor-nurse-HCA team according to a     protocol based on risk stratification with predefined follow up (FU) schedules together with     shared information and decision support (i.e. structured collaborative care). The DIAMOND     protocol involves only baseline and yearly CA without predefined FU schedules or feedback of     information between CA visits (i.e. usual care).      The primary composite endpoint is all-diabetes related clinical endpoints. The secondary     composite endpoint is attainment of treatment goals and/or control of risk factors. The     tertiary changes are behavioral changes, psychological well being and quality of life.   "
126364|NCT01631071|"     The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills     the EMA requirements for re-registration of influenza vaccines.   "
126365|NCT01631058|"     An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low     tacrolimus for the immunosuppression in renal transplantation in the elderly.      To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this     population.      To evaluate whether the polymorphism of the genes that determine the expression of     metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the     younger population, absorption and metabolism of immunosuppressants.      To evaluate the potential minimization of immunosuppression in this population refers to how     does the re-population of peripheral lymphocytes, in this age group, after the use of     lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two     regimes.      Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is     the right to monitor renal function in elderly transplanted.   "
126366|NCT01631045|"     Scientists have studied how fasting and nutrients affect brain function in animals. The     purpose of this study is to look at the effects of both fasting and food intake on brain     function and memory in humans. To do this the investigators will use functional MRI to     observe the brain and its function while fasting and after a meal. Understanding the action     of these hormones in the brain may eventually lead to new ways to help people avoid obesity     or lose weight.   "
126367|NCT01631032|"     Allergic rhinitis is a common but complicated immunologic disorder disease and multiple     western medicine has been used for symptom control. Chinese herbal medicine, one of the most     commonly used complementary and alternative medicine in Taiwan, has also be used for allergic     rhinitis control. This study is designed to explore the efficacy and possible underlying     immune-modulation effect of the BZYQT, which is one of the most famous Chinese herbal     medicine used for allergic rhinitis in daily practice.   "
127029|NCT01622348|"     The purpose of this study is to evaluate different dose levels of IMO-3100 compared to     placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.   "
126368|NCT01631019|"     Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity     and increased oxidative enzyme activity, as well as exercise tolerance in Chronic Obstructive     Pulmonary Disease (COPD) patients.      Design: To investigate the home-based exercise training program can reduce inflammatory     biomarkers in COPD.      Setting: Conducted from January 2007 to December 2007 at a tertiary medical center, Chang     Gung Memorial Hospital, Taiwan.      Patients: Moderate to severe COPD receiving home exercise training, 12 using mobile phone     assistance and 14 with free walk, were assessed for 6 months.      Measurements: Incremental shuttle walk test (ISWT), spirometry, strength of limb muscles,     C-reactive protein (CRP) and inflammatory cytokines.   "
126369|NCT01631006|"     Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of     disability including heart failure, atrial fibrillation, and sudden death, with an annual     mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among     patients with established cardiovascular disease, including hypertension and atrial     fibrillation and when present may contribute to worse cardiovascular outcome. Although     patients with HCM do not necessarily have typical characteristics of patients with OSA, such     as obesity and increasing age, there is recent evidence that OSA is extremely common among     patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among     patients with HCM is independently associated with worse structural and functional impairment     of the heart, including atrial and aorta enlargement, worse New York Heart Association     functional class, and worse quality of life. Therefore, the recognition and treatment of OSA     is a new area of research that may impact in the management of patients with HCM.   "
126370|NCT01630993|"     The purpose of this pilot study is to determine if umbilical cord milking at the time of     scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants     as determined by hemoglobin and hematocrit levels at 36-48 hours of life. This study will     help to establish the feasibility of umbilical cord milking as an alternative to delayed     clamping at the time of planned cesarean section.   "
126371|NCT01630980|"     Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts,     pistachios and walnuts) are an important source of unsaturated fatty acids, vegetable     protein, and fibre, as well as minerals, vitamins, and phytonutrients. Although heart disease     risk reduction claims for nuts have been permitted in the U.S. and general dietary guidelines     and recommendations from heart associations recommend the consumption of nuts for heart     protection, diabetes associations have not addressed nuts in their most recent     recommendations. This omission is despite heart disease being a major cause of death in     diabetes. There remains insufficient information on the usefulness of these foods in     diabetes. To improve evidence-based guidance for tree nut recommendations, the investigators     propose to conduct a systematic review of the effect of tree nuts on diabetes control and     features of the metabolic syndrome. The systematic review process allows the combining of the     results from many small studies in order to arrive at a pooled estimate, similar to a     weighted average, of the true effect. The investigators will be able to explore whether     eating tree nuts has different effects between men and women, in different age groups and     background disease states, and whether or not the effect of tree nuts depends on the dose and     background diet. The findings of this proposed knowledge synthesis will help improve the     health of Canadians through informing diabetes association recommendations and heart     association recommendations where they relate to diabetes.   "
126372|NCT01630967|"     Men with castrate resistant prostate cancer who are switched from a luteinizing     hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in     prostate-specific antigen (PSA).   "
126373|NCT01630954|"     Hydatidiform mole is a common complication of pregnancy with an incidence of 1in 400     pregnancies in India. Although this is a benign condition , it is having the malignant     potential too. A repeat curettage after evacuation of hydatidiform mole was generally     advocated till 1990s. A thorough curettage at the time of initial evacuation was not     performed because of larger size of uterus and risk of perforation. Subsequently a number of     studies assessed the usefulness of repeat curettage and found it was unnecessary and not cost     effective . However all these studies are retrospective in design and conducted in developed     countries where hydatidiform mole is diagnosed earlier because of wider use of     ultrasonography. Thus there is a need to perform a well designed prospective study to compare     the effectiveness of single evacuation with double evacuation in treatment of hydatidiform     mole for prevention of Gestational Trophoblastic Neoplasia.This study compares the     effectiveness of single evacuation versus double evacuation for treatment of hydatidiform     mole for prevention of gestational trophoblastic neoplasia .   "
126374|NCT01630941|"     The primary objective is to study the effect of Denosumab on Bone Mineral Density,     Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The     primary hypothesis is to demonstrate that Denosumab is superior to placebo.   "
126375|NCT01630928|"     The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is     done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive,     percutaneous technique where an ablation catheter is inserted through a femoral artery into     the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia     by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys,     which in the Symplicity trials led to an impressive reduction of blood pressure (- 33 /-11     mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have     beneficial effects not only on blood pressure, but also on insulin sensitivity and     hyperinsulinaemia.      The investigators aim to introduce RDN as a clinical study where blood pressure reduction and     methodical, technical aspects will be evaluated, but more importantly, also additional     effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness,     fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The     investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and     sub-clinical organ damage.   "
126376|NCT01630915|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 ×     75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a     washout period of 7 days.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
126383|NCT01630824|"     Kidney transplantation is the treatment of choice for patients with end-stage renal disease.     The purpose of this randomized and controlled study is to evaluate the efficacy of a     structured education program for adult kidney transplant recipients. Patients are randomly     assigned to an educational program or to a standard care control group. The education group     receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney     transplantation. Kidney transplant survival, number of rejections, infectious complications,     length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life     (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators     postulate that the education group will have superior outcomes compared to the control group.   "
126384|NCT01630811|"     Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by     the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8     weeks over subjects given placebo.      Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt     Aggression Scale (OAS).   "
126385|NCT01630798|"     You are invited to participate in a research study to develop new ways to look for abnormal     areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are very     good, but if the area doesn't look different to the naked eye, then the endoscope can't     improve on that. The investigators are looking at using special fluorescent stains in     addition to special endoscopes designed to see abnormal areas that are not obvious to the     naked eye. Currently specialized microscopes and fluorescent stains are used in clinical     laboratories but it takes several days of processing to get results. It may be very helpful     to look for areas to sample for abnormal tissue during the endoscopy procedure.      You are being asked to let us use fluorescent peptides with a special endoscope that allow     us to see your esophagus with both fluorescent and white light during your upper GI     endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids     (the building blocks that make up proteins) linked together. Our peptide is a chain of 7     amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor).      The investigators have prepared special fluorescent peptides, that will glow when a     special light is used that should help us separate normal tissue from abnormal tissue. In     this study, the investigators will apply the special fluorescent peptides by a spray catheter     to your esophagus to help us target you biopsies. Both routine and targeted biopsies will be     taken as your endoscopist feels is indicated.      This is a phase 1b study. This means that although the investigators have applied the peptide     to 25 people in our first research study, the investigators still need to learn more about     fluorescent peptide in people. The Food and Drug Administration (FDA) has not approved this     agent, but is allowing us to test it in this study. The main goal of this study is to see if     the peptide glows well and if the investigators can take pictures of the areas that do     glow.      This is a research study of the peptide and our ability to see it light up or fluoresce.     Being in this study and applying this peptide won't change how your biopsies are taken nor     how your endoscopy is done.   "
126386|NCT01630785|"     The investigators record the outcome of patients whose surgery involved intraoperative     neurophysiological monitoring        -  Trial with surgical intervention   "
126387|NCT01630772|"     The aim of this study is to evaluate the influence that has a physical therapy protocol in     maternal and fetal hemodynamics in relation to blood pressure, maternal and fetal responses     and perinatal outcomes.   "
126388|NCT01630759|"     When women with diabetes become pregnant it is particularly important to control blood sugar     levels to prevent complications. Women are advised to test their blood glucose levels seven     times a day and to attend antenatal and diabetes clinics every 1-2 weeks throughout the     pregnancy. For those living in rural areas in the North and West of Ireland getting to a     hospital specialising in the management of diabetes and pregnancy on such a regular basis can     be a challenge.      Telemonitoring provides a possible solution to this problem by allowing patients to monitor     their vital signs at home and transmit the information via telephone to their healthcare     provider. If women could be safely monitored remotely for every other appointment it would     mean that they would only need to visit the hospital once a month on a routine basis but with     the option of attending the hospital if the remote telemonitoring indicated that this were     necessary.      The aim of this study is to assess the feasibility and the acceptability of using remote     telemonitoring facilities between antenatal women with gestational diabetes and the diabetes     team and the possibility of replacing alternate diabetic review clinics with remote     telemonitoring. In addition this study will explore the feasibility of running a full     randomised control trial of this topic.      Women will be asked to monitor their blood sugar levels seven times a day which is part of     usual care. However those in the remote telemonitoring group will be asked to measure their     blood sugar using a meter that can transmit the results via a telephone line and to transmit     them weekly. They will also be asked to measure their blood pressure and weight weekly and to     download these results weekly for a health care professional to review. These results will be     reviewed on a weekly basis by a health care professional who will contact the patient if     necessary to discuss the results. Women will be followed-up from the date of diagnosis     through to delivery.      Both staff and patients will be asked to give their views on the safety and acceptability of     remote telemonitoring through questionnaires, focus groups or interviews. The management     decisions made on reviewing the intervention group in clinic and reviewing remote     telemonitoring results will also be recorded. In order for remote telemonitoring to be a     viable replacement for clinic review it must allow health care professionals to make     comparable management decisions. Clinical data will be collected in order to provide     descriptive statistics for those who take part and to ensure that this information could be     collected in any future Randomised Control Trial (RCT) looking at this topic.   "
126389|NCT01630746|"     The purpose of this study is to evaluate the acid-inhibitory and dose-response efficacy of     TAK-438 (20 mg, 40 mg) in patients with PPI-resistant erosive esophagitis.   "
126390|NCT01630733|"     The primary objective of the study is to compare overall survival of patients randomized to     receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive     docetaxel alone (Arm B).   "
126391|NCT01630720|"     There is a high prevalence of hypovitaminosis C and D in our hospital and other acute-care     hospitals. Since the correction of these presumed deficiency states is simple, safe and     inexpensive, their documented or suspected presence would normally be considered sufficient     indication to correct them. However, the common practice is to ignore them. Identification of     specific measurable medical consequences of hypovitaminosis C or D would provide a stronger     case to treat or prevent in-hospital vitamin deficiency states.      Biochemical deficiencies of vitamin C and D have both been linked to mood disturbance, and     hypovitaminosis C reportedly increases blood histamine concentrations.      We recently found that the provision of vitamin C (500 mg twice daily) but not vitamin D     (1000 IU twice daily) promptly improved the average mood score of acutely hospitalized     patients. We will now conduct a closely similar randomized clinical trial using a more     adequate dose of vitamin D, namely 5000 IU/day for up to 10 days.   "
126392|NCT01630694|"     The purpose of this study is to identify differences in craniofacial morphology and tongue     size between patients who have a history of difficult airway management and a control group     of patients who had an uneventful airway management during induction of general anesthesia.     In this study the investigators want to validate the hypothesis that there are craniofacial     phenotypic differences between patients who have a history of difficult airway management and     a control group of patients who have had an uneventful airway management during the induction     of general anesthesia.   "
126458|NCT01629823|"     The CPAP trial is a 3-arm parallel design randomized sham-controlled trial. Participants are     randomly assigned in equal allocation to one of three treatments: CPAP 10 cm water (H₂O)     (high) vs. CPAP 5 cm H₂O (medium) vs. CPAP Sham (less than 1 cm H₂O, Low). The treatment     period is 12 weeks with airways reactivity assessed at baseline, 6 and 12 weeks of treatment     and after a 2 week washout.   "
126459|NCT01629810|"     The purpose of this study is to test the effectiveness of whole body periodic acceleration     for helping with symptoms of aches and pains suffered by many patients.   "
126393|NCT01630681|"     The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and     health related quality of life in cancer patients with anxiety and depression symptoms,     compared to Standard Care, and to evaluate the health-economic effects of the intervention.     The investigators also want to examine the development of anxiety and depression symptoms and     health related quality of life in cancer patients without initial symptoms.      The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in     relieving anxiety and depression symptoms in cancer patients, compared to Standard Care (SC).     Secondary hypotheses are that less anxiety and depression symptoms also means improved health     related quality of life and that I SC is cost-effective or at least cost neutral compared to     standard care.      The IT-platform Carebase.se is developed within U-CARE. The platform will be used for     delivering of interventions and for collection of all patient reported outcomes. Patients     with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale     will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms     will be included in descriptive studies. All patients, in the randomized controlled trial and     the descriptive study will followed up during 24 months      I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2).     Step 1 starts directly after randomization and extends over a 24 months period. Step one     comprises web-based patient education including psycho-education and easy interventions     strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and a     personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the     discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to     other experts in the project group for advices about how to answer patients' questions.      Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after     randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for     common psychological concerns. The participants' chooses to work with modules that correspond     to prioritized concerns, e.g. anxiety or depression. The CBT is structured and manualized and     include conventional treatment methods with homework and weekly contacts with the     psychologist. Step 2 extends over a 10-week period.   "
126394|NCT01630668|"     Background: In recent years, probiotics have shown promise in treating a variety of diseases.     Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri     NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.      Objective: The purpose of the study is to determine the lipid lowering efficacy of a     One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12     weeks in subjects with hypercholesterolemia.      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,     multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period     and a 12-week intervention period.   "
126395|NCT01630655|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan     Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were     separated by a washout period of 17 days during fasting study.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
126396|NCT01630642|"     Objective:      Primary objective of the present study was to compare the single dose bioavailability of     Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 ×     75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a     washout period of 7 days.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
126397|NCT01630629|"     Changes in maternal calcium metabolism are necessary during lactation to provide adequate     calcium in breast milk for development of the newborn skeleton. The calcium in milk is     derived from the maternal skeleton, resulting in significant bone loss, a process thought to     be mediated by the actions of parathyroid hormone-related protein (PTHrP) in combination with     a decreased estrogen levels. After weaning, bone lost during lactation is rapidly regained.      Differences between African-American and Caucasian bone metabolism are well documented and     include higher bone mineral density (BMD), lower risk of fragility fracture, lower     25-hydroxyvitamin D (25(OH) D), and higher PTH in African-Americans compared to Caucasians.     Most studies of bone metabolism in lactating women have been done in Caucasians. Because of     differences in bone metabolism between African-Americans and Caucasians, we do not know     whether African-Americans will have similar findings.      The primary aim of this study is to compare the changes in bone mineral density (BMD) during     lactation in African-Americans with those in Caucasians. It is not known whether the loss in     BMD during lactation will be the same for both races. African-Americans display skeletal     resistance to PTH with short-term infusions and have lower bone resorption, higher BMD and     lower fracture risk than Caucasians. A recent study by our group indicated that lactating     African-American mothers had slightly lower bone resorption but quantitatively similar bone     formation compared to Caucasians. However, there was a significant increase of 2-3 fold in     markers of bone formation and resorption in both groups. Therefore, it is currently not known     whether the loss in BMD during lactation will be the same for both races. Primary outcome     measures in this study will include spine, hip and radius BMD by Dual X-Ray Absorbiometry     (DXA)Scans during lactation (at 2,12 and 24 weeks postpartum or at weaning if prior to 24     weeks postpartum, and six months after weaning (+1 week). This longitudinal protocol will     distinguish between two hypotheses. Either: a) as measured by BMD, bone loss in     African-Americans during lactation will be equal to that in Caucasians, and skeletal recovery     will be the same or possibly accelerated compared to Caucasians; or, b) African-Americans     will be resistant to bone loss during lactation compared to Caucasians because of resistance     to Parathyroid Hormone-related Protein (PTHrP).   "
126398|NCT01630616|"     This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of     single doses of odanacatib in mature adolescents and young adults who are currently receiving     glucocorticoid therapy.   "
126399|NCT01630603|"     Objectives:        1. To determine the incidence of vitamin D deficiency among Israeli pregnant women        2. To access whether maternal vitamin D status affects infant bone strength.      Methods:        1. Vitamin D levels -in cord blood and maternal blood        2. The mother will fill a demographic and nutritional questionnaire           The Infants:        3. Growth assessment of the infants: weight length and head circumference        4. Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)   "
126400|NCT01630590|"     The goal of this clinical research study is learn if adding cabozantinib (also known as     XL184) to hormonal therapy can help to control prostate cancer. The safety of this drug will     also be studied.      Cabozantinib is designed to block certain proteins in your blood that cause cancer cells to     grow. This may cause cancer cells to die.   "
126401|NCT01630577|"     We conducted this study to assess the value of early change in central venous pressure (CVP)     in predicting fluid responsiveness in mechanically ventilated patients.   "
126402|NCT01630564|"     The goal of this clinical research study is to learn about the highest tolerated dose of T     cells that can be safely given to patients whose cancer has returned after a umbilical cord     blood transplant (UCBT).   "
126403|NCT01630551|"     Ocular surface disease (OSD) is a significant health problem that affects more than 10     million persons in the United States alone. OSD is highly prevalent among medically treated     patients with glaucoma and is associated with the number of intraocular pressure     (IOP)-lowering medications used.      The purpose of this study is to determine the potential effectiveness of anoritega-3 fatty     acid nutritional supplement in the treatment of ocular surface disease associatedwith the     use of glaucoma eye drops   "
126404|NCT01630538|"     The study hypothesis is that short-term low dose cyclophosphamide therapy will be effective     in resolving inflammation in patients with late phase antibody-mediated rejection refractory     to current standard of care treatment.   "
126664|NCT01627132|"     The purpose of this study is to assess whether dasatinib can be discontinued without     occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in     complete molecular remission (CMR) while on dasatinib.   "
126665|NCT01627119|"     For the past 50 years, gastric cancer has been one of the ten most frequent cancers and the     second leading cause of cancer-related death in the world. In Taiwan, it is the fifth most     common cause of cancer-related deaths, accounting for 6.3% of all cancer deaths. The poor     prognosis of gastric cancer is mostly caused by the extensive metastasis to the lymph nodes,     liver, and peritoneal dissemination even if curative resection was performed. The main cause     of recurrence after curative or noncurative resection of advanced tumors is peritoneal     metastasis because of possible direct spillage and dissemination of tumor cells as a result     of surgical manipulation, and it is associated with a poor prognosis. As yet, no effective     treatment has been developed for this condition. The development of peritoneal metastasis is     a multistep process, beginning with attachment to peritoneal mesothelial cells, retraction of     the mesothelial cells and exposure of the basement membrane, attachment to the basement     membrane, degradation in the extracellular matrix, proliferation by the cancer cells, and     angiogenesis, and it is clear that many types of agents are involved at the various stages of     this process. Developing a new therapeutic method for this mode of metastasis is very     important for improvement of gastric cancer treatment.      CTGF is a secretory protein belonging to the CCN family (one among the three originally     discovered members: cysteine-rich61, CTGF, and nephroblastoma-overexpressed gene). It is a     multifunctional growth factor involved in wound healing, inflammation, cell adhesion,     chemotaxis, apoptosis, tumor growth, and fibrosis. Recent studies showed that overexpression     of CTGF in human oral squamous cell carcinoma reduces cell growth and tumorigenecity. Similar     tumor growth inhibitory effects were observed in lung cancer cells in which CTGF     overexpression was less angiogenic and metastatic due to blocking of the VEGF A signaling     pathway. CTGF was also reported to be a key regulator of colorectal cancer invasion and     metastasis, and it appears to be a better prognostic factor. These studies suggest that CTGF     may involve the processes of peritoneal metastasis which includes cancer cell adhesion in     peritoneum, proliferation and angiogenesis. Peritoneal mesothelium is the first surface     encountered by disseminated tumor cells and successful adhesion is, therefore, of paramount     importance in metastasis formation. Therefore, we hypothesized that CTGF is a potential     molecule target, which may be related to cell adhesion to peritoneum, the first step of     peritoneal metastasis, and its exact mechanism may includes proliferation and angiogenesis.      In order to answer these important questions, first, we have performed the preliminary     studies to prove CTGF did express in different gastric cancer cell lines including AGS, N87,     TSGH, and MKN-45 by using RT-PCR and Western blotting, and gastric cancer tissues by using     immunohistochemical method. Second, we demonstrated different levels of CTGF expression in     different cell lines pose different adhesion ability in in-vitro adhesion assay. Third, we     conducted a transient CTGF-overexpressed MKN45 gastric cancer cell line, and     CTGF-overexpressed cell line had lower adhesive ability compared to the control.      Next step in this project, we will be studying the roles of CTGF plays in cellular and     molecular biology in vitro and in vivo and clinical significance associated with therapeutic     potential of peritoneal metastasis from gastric cancer. We will generate stable clones of     MKN45 cells harboring CTGF and its control cell line to elucidate the roles of CTGF in cancer     cell adhesion, proliferation and angiogenesis in peritoneum.   "
126405|NCT01630525|"     Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle     executive cognitive function deficits can be detected at this early pre-dementia phase, more     than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been     shown to be altered very early, up to 13 years before dementia. This test, as many others     executive function tests, requires a fine control of visuomotor coordination. Like executive     functions, eye movements, particularly voluntary-guided saccades, are under the control of     the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of     voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although     the pathological process of the disease affects very early brain structures implicated in     saccades execution (eg. caudate nucleus and pre-cuneus).   "
126406|NCT01630512|"     The purpose of this study is to determine whether mindfulness-based cognitive therapy     (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in     patients with diabetes.   "
126407|NCT01630499|"     Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest     among women with a history of breast cancer (stages 1-3) who are also overweight or obese.     The purpose of this study is to compare a tailored nutrition, physical activity, and     behavioral weight management program for breast cancer survivors against a widely available     commercial weight management program. We hypothesize that an intervention tailored to the     unique psychological, nutritional and physical needs of breast cancer survivors will provide     superior physiological and psychological benefits compared to an existing commercial program.   "
126408|NCT01630486|"     The goals of the KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney     Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to     10-year follow-up, and 2) to investigate the renal progression, mortality, complications,     risk factors, role of biochemical parameters and the genetic influence.      KNOW-CKD Research Group comprises nephrologists, pediatric nephrologists, epidemiologists and     statisticians from eleven centers in Korea. KNOW-CKD will enroll 2,850 individuals with CKD     stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. Dialyzed patients or     those with allograft kidney are excluded. At enrollment and at pre-specified intervals,     laboratory tests will be conducted on the kidney function, biochemical profiles, anemia,     cardiovascular complication (echocardiography, coronary CT, arterial stiffness), and mineral     bone disorder. A biobank is also established for the DNA, serum and urine at regular     interval. Information on the medical history, health questionnaires, QoL will also be     collected. Web-based case-report forms (CRF) is developed for the systemic management of the     patient data.   "
126409|NCT01630473|"     Orthodontic therapy allows for the treatment of dental malpositions in order to produce an     adequate relationship between teeth during occlusion. Conventional orthodontic therapy     applies slight forces and moves teeth slowly. It is generally performed during a 2 year     minimum of time. Recent studies seem to suggest that orthodontic therapy time can be     shortened by surgical assistance (corticotomy). This investigation is aimed to determine the     velocity of tooth movement and changes in periodontal clinical parameters between     corticotomy-assisted orthodontic therapy and conventional orthodontic therapy.   "
126410|NCT01630460|"     CMD can be inherited in an autosomal dominant or recessive trait. CMD may also be caused by     de novo mutations. The goal of this study is to identify genes and regulatory elements on     chromosomes that are the cause for CMD. The investigators also study blood samples and tissue     samples from patients to learn about the processes that lead to this disorder. The     investigators long-term goal is to find mechanisms to slow down bone deposition in CMD     patients.   "
126411|NCT01630447|"     The goal of this research study is to identify genes and regulatory elements on chromosomes     that cause cherubism. Together with the investigators collaborators the investigators also     study blood samples and tissue samples from patients to learn about the processes that lead     to this disorder. The long-term goal of researchers involved in this study is to find     mechanisms to slow down bone resorption in cherubism patients.   "
126412|NCT01630434|"     A prospective, international, multi-center, randomized controlled trial comparing     preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush     and storage (Control Group).   "
126413|NCT01630421|"     The goal of this research study is to identify genes and regulatory elements on chromosomes     that cause ACC. The investigators also study tissue samples from patients to learn about the     processes that lead to this disorder.   "
126414|NCT01630408|"     This is a pilot feasibility study to determine the effects of an activated vitamin D compound     (paricalcitol) on heart structure (size) and function (ability to relax) in patients with     normal kidney function and a form of heart failure known as HFPEF (heart failure and     preserved ejection fraction). This study will also examine heart failure-related     hospitalizations and changes in cardiac-stretch and biological markers that are believed to     change along with heart size. Patients in this pilot study will be treated for a period of 48     weeks with paricalcitol at a dose previously approved by FDA (1 mcg per day) and followed-up     for 4 weeks after treatment is completed.   "
126415|NCT01630395|"     The purpose of this study is to determine if a recruitment maneuver combined with protective     ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to     one-lung ventilation during thoracic surgery.   "
126416|NCT01630382|"     The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal     fluid congestion.   "
126417|NCT01630369|"     Primary Objective:      - To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2     Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)      Secondary Objectives:        -  To evaluate the percentage of patients with Hb A1c < 7.5%,        -  To evaluate the rate of hypoglycaemia (symptomatic, severe)        -  To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb,          Insuman Rapid after 6 month treatment        -  To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment        -  To assess the overall safety        -  To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers          after second test compare to the testing of the initial level)   "
126666|NCT01627106|"     This study will compare vernakalant therapy to amiodarone therapy in the acute management of     recent onset atrial fibrillation.   "
126418|NCT01630356|"     This study was designed to test the hypothesis whether a novel intervention that uses     motivational interviewing along with immediate feedback and follow-up counseling calls is     effective in educating the household members about the health hazards of smoking and     secondhand smoke exposure and reducing children exposure to secondhand smoke at households in     Armenia.      The study was a randomized control trial with two arms: intervention and control groups.      The sample population for the study included households with a non-smoking mother and at     least one child 2 to 6 years of age residing with at least one daily smoker. The study team     recruited the households through pediatrician's offices in polyclinics (primary healthcare     facilities) utilizing multistage random sampling. Trained interviewers made two baseline (one     week apart) and two 4-month follow-up household visits to conduct measurements, interviews     and intervention. Measurements included surveys, air nicotine monitoring in homes and hair     samples from children to assess changes in nicotine concentration over time.      SHS concentration was estimated by sampling vapor-phase nicotine using a filter badge treated     with sodium bisulfate. Airborne nicotine monitors were used in all homes to measure SHS     concentration at baseline and 4 month follow-up. At least one monitor was used in each home,     preferably in the main room in which the family congregates.      Personal exposure to SHS in 2-6 years old children was assessed using biological samples of     hair. A small sample of hair (approximately 30 - 50 strands, 2-3 cm) was cut near the hair     root from the back of the scalp where there is the most uniform growth pattern between     individuals which minimizes the variability of the results.      The intervention included an in-person counseling session with distribution of a tailored     educational brochure and demonstration/feedback measurement of indoor PM2.5 (at second     baseline visit); it also included one and two months follow-up counseling calls. The control     group received only a brief educational leaflet on the hazards of second-hand smoke exposure.   "
126419|NCT01630343|"     The Null Hypothesis is that there is no association between Pain regime and the functional     performance among geriatric patients having traumatic hip fracture. Two limbs are being     assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral     Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate     Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are     chosen.   "
126420|NCT01630330|"     There are multiple important factors which need to be monitored when conducting ablation for     atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is     now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation     patients.   "
126421|NCT01630317|"     Slow continuous ultrafiltration using central vs peripheral line: feasibility of     implementation, safety and efficacy in acute heart failure syndromes.   "
126422|NCT01630304|"     The purpose of this study is to determine whether weekly text-messages improve retention in     care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).   "
126423|NCT01630291|"     The purpose of this study is to investigate whether electrical stimulation of the nerve     innervating the tear gland results in tear production in subjects with severe Dry Eye.   "
126424|NCT01630278|"     Very premature infants with a large ductus, selected by an early echocardiogram, will receive     either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated     echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional     age. The primary outcome will be survival without cerebral palsy at years.   "
126425|NCT01630265|"     Previous studies demonstrate that patients often have difficulty understanding their     discharge instructions. Video discharge instructions have the potential to mitigate factors     such as illiteracy and limited physician time, which may affect comprehension. Our goal is to     determine if adding video discharge instructions affects caregivers' understanding of their     child's emergency department (ED) visit, plan and follow-up.   "
126426|NCT01630252|"     This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating     the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001     orally administered for up to 5 months with concomitant DMPA administration for the treatment     of laparoscopically diagnosed inflammatory endometriosis. The part A1 is open-label, the     parts A2 and B are double-blind.      The target population will be women of reproductive age and suffering from newly diagnosed     peritoneal and/or ovarian endometriosis.   "
126427|NCT01630239|"     This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal     Therapy (LITT) in the treatment of liver tumors.   "
126428|NCT01630226|"     This is a single center, non-randomized, open label phase II trial to evaluate the clinical     and pathologic response of neoadjuvant cisplatin-monotherapy in BRCA1 positive patients. The     study will enroll patients with diagnosed breast cancer with a BRCA1 mutation. Patients will     be eligible if they have primary breast cancer (measured on mammogram and ultrasound or MRI)     and confirmed histological diagnosis of invasive breast cancer by core biopsy. If axilla     lymph nodes will be suspected then fine needle aspiration biopsy will be performed. Patients     will be drawn from one of three oncology centers: Szczecin, Bielsko-Biała and Kraków.      Patients will obtain staging investigations and will be monitored. Once entry criteria is met     and consent obtained, all patients will obtain baseline staging investigation within 3 weeks     of trial registration. Routine investigations will include staging scans: mammography,     ultrasound of the breast and axilla (assessment of breast tumor and axilla lymph nodes),     assessment of chest/abdomen/pelvis (plain film, Computed Tomography [CT] and/or ultrasound as     per local standards) and baseline blood work (Complete Blood Count [CBC], electrolytes,     creatinine, Liver Function Tests [LFTs], calcium, albumin).      Once staging investigations are complete, all patients will be treated with cisplatin     chemotherapy at a dose of 75mg/m2 every three weeks for a total of four cycles (4 cycles of     neoadjuvant chemotherapy). Clinical response will be evaluated every three weeks by the     treating physician while on chemotherapy (tumour of the breast and axilla lymph nodes). After     four cycles of chemotherapy the patient will then undergo definitive surgery (mastectomy or     breast-conserving surgery). Sentinel lymph nodes procedure will be performed. In case of     positive lymph nodes standard lymph nodes surgery will be performed. Pathological complete     response will defined as no evidence of residual tumor in the breast and the axilla. There     may be evidence of ductal carcinoma in situ. The pathology will reviewed by two independent     pathologists.      Following surgery patients will receive standard adjuvant chemotherapy at the discretion of     the treating physician and if indicated, the patient will also receive radiotherapy and/or     hormonal therapy and/or adjuvant trastuzumab at the description of the treating physician.   "
126429|NCT01630213|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study (VITAL-Echo) is being conducted among participants in VITAL     and will examine whether vitamin D compared to placebo: (1) reduces left ventricular (LV)     mass in elderly individuals as measured with 2-dimensional echocardiography and (2) improves     LV systolic and diastolic function as measured with tissue Doppler echocardiography.   "
126482|NCT01629511|"     The goal of this clinical research study is to learn the highest tolerable dose of     gemcitabine (out of 4 possible doses) that can be given in combination with busulfan and     clofarabine before an allogeneic stem cell transplant. Researchers also want to learn if this     combination can help to control CLL. The safety of this treatment will also be studied.      Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer     cells to die. It is commonly used in stem cell transplants.      Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may cause     the cancer cells to die.   "
126430|NCT01630200|"     Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory     process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and     mortality in COPD. Early changes of vascular integrity can be detected via markers of     subclinical atherosclerosis.      Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option     in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an     anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.      The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor     Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of     systemic inflammation in the peripheral circulation of patients with stable chronic     obstructive pulmonary disease.   "
126431|NCT01630187|"     The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg     vs 100 mcg) in preventing uterine atony during elective cesarean section.   "
126432|NCT01630174|"     To evaluate the effect of concomitant late course accelerated hyperfractionation     radiochemotherapy with pemetrexed and cisplatin in patients with esophagus cancer   "
126433|NCT01630161|"     The purpose of this study is to test different ways to help cancer patients maintain their     smoking abstinence. Participants may receive educational materials as part of the study.   "
126434|NCT01630148|"     The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women     who undergo gynecologic surgery for benign conditions world wide and especially in developing     countries including our region. Having a research in our locality for the first time might     raise awareness of the importance of VTE prophylaxis.   "
126435|NCT01630135|"     Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in     Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be     evaluated compared with placebo.   "
126436|NCT01630122|"     The goal of this study is to demonstrate the feasibility of using a novel, validated panel of     Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the A/S signature) as a     diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.      Objectives:        1. To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.        2. To define a fixed statistical model of histologic subtype prediction in NSCLC.      Study methods: To establish FNA biopsy requirements for gene expression-based subtype     classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic     studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy     according to current standard techniques . For this part of the study, approximately 40     biopsies of confirmed NSCLC will be collected for analysis.      To define a fixed statistical model of histologic subtype prediction in NSCLC, we will     prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous     Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise     specified (NOS), should they be encountered, may also be collected for later analysis. FNA     samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the     findings of our primary objective)will be assayed on the QGS platform.   "
126437|NCT01630109|"     Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to     either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior     to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design.     The outcomes to be assessed are capsule study completion rates, gastric transit time, small     bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose     of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any     effect on pill capsule completion rate, gastric transit time, small bowel transit time, and     pill capsule completion rates in diabetes.   "
126438|NCT01630096|"     Once the lab test is positive for c. diff, the investigators will order the patient to have     PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not     clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for     500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as     well. The investigators will plan to check c. diff tests daily to see when they become     negative. The investigators will perform chart audit/review to track mortality, the length of     stay, ICU days, surgical intervention, and APACHE scores (assessment of disease severity).     Chart audit will be used to collect data on their diet and how they feel using a visual     analog scale (collected by nursing staff daily as a standard procedure; see attached pain     scale). Using chart audit, the investigators will record whether the patient is     immunocompromised or not.   "
126439|NCT01630083|"     The purpose of the trial is to assess the therapeutic effects and the safety profile of     IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for     patients with advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal     junction compared to EOX alone.      Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral     activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical     efficacy threshold will be investigated.   "
126440|NCT01630070|"     The objective of this clinical study is to evaluate the immediate and long-term (up to 12     month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the     treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers)     due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm     long.   "
126441|NCT01630057|"     An open-label, randomized, multi-centre, superiority study to assess that, in patients who     respond to zonisamide added as third drug after failure of a two-drug combination therapy,     the triple therapy is superior to the conversion to a double therapy including zonisamide.   "
126442|NCT01630044|"     This is a prospective, non-randomized and unblinded study designed to generate preliminary     data to assess the effect of a new portable non-invasive brainstem stimulator to treat     migraine headaches in patients with episodic migraine headaches.   "
126526|NCT01628939|"     The purpose of this study is to determine        1. the prevalence of lumbar facet joint pain detected by manual segmental provocation tests        2. the prevalence of MRI findings of the lumbar facet joints (hypertrophy, effusion, edema)        3. the association of lumbar facet joint pain and MRI findings on a segmental level      in subjects with current low back pain and in a control group.   "
126443|NCT01630031|"     Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial     fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to     PVs reconnection. In this setting, all procedural means able to improve the quality of tissue     lesions are welcome.      Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a     new catheter available on the market, was a valuable additional tool increasing the efficacy     of the ablation procedure for PVI.      Methods - Prospective observational non-randomized monocentric study. Patients with     paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter     ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF     ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter,     Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER     THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive     patients are enrolled in the study, with 30 patients in each group. All procedures is     performed by the same experienced operator, not blinded to the catheter used. Except for CF     information (with an objective of at least 10 g, associated to the most perpendicular vector     obtainable), ablation procedures are carried out using identical approaches in both groups.     Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled     in a specific follow-up plan.      Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of     patients free of AF after 12-month follow-up.   "
126444|NCT01630018|"     The purpose of this study is to determine the efficacy and safety of belotecan or topotecan     in patients with recurrent or refractory ovarian cancer (AOC).   "
126445|NCT01630005|"     Strokes are the first cause of acquired physical disability among adults. Some studies proved     that depression is often an unrecognized complication from stroke, associated with a vital     prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of     the existence of a particular psychological state after stroke particularly favorable to a     psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the     feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after     stroke.   "
126446|NCT01629992|"     The investigators examined whether a written plus verbal preoperative counseling for patients     undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting     and pain.   "
126447|NCT01629979|"     The effects of treatment of transplantation of harvested autologous epidermal cells on     vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled     study.   "
126448|NCT01629966|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone     relative to placebo in the treatment of generalized anxiety disorder (GAD)   "
126449|NCT01629953|"     This study continues to develop and refine best practices in the delivery of vocational     services to veterans with histories of felony convictions and mental health/substance abuse     difficulties. There are currently over 225,000 incarcerated veterans and it is estimated     64,000 veterans are released from prisons annually. These veterans encounter significant     difficulties in finding employment due to stigma, intrapersonal difficulties, and out-dated     work skills. Additionally these veterans are more likely to be homeless than other     population., Previous work has found that manual based, vocational groups led by trained     vocational staff led to quicker employment compared to traditional vocational services and     manual based self studies. To attempt to improve on previous results, this study adds     principles and components of supported employment including ongoing follow-up, treatment team     coordination, and community based assistance.   "
126450|NCT01629940|"     The investigators propose to obtain facial photographs for use in testing a computer     algorithm that recognizes males at high risk for Hypohidrotic Ectodermal Dysplasia (XLHED).     FDNA (www.fdna.com), a software company with expertise in the area of facial recognition, is     collaborating with the Sponsor in algorithm development based on 2D photographs not requiring     special photographic technologies. A frontal facial photograph will be taken at the time of     study conduct. The anonymized photographs will be transmitted to FDNA for analysis. A limited     number of unaffected controls will be also be recruited.      A subset of affected males between ages 5 and 25 years will have the option of having a blood     draw for a set of laboratory studies assessing nutritional status.   "
126451|NCT01629927|"     The study proposes to enroll male subjects affected by Hypohidrotic Ectodermal Dysplasia     (XLHED). The sweat duct images will be acquired with a CE marked skin-imaging device and the     sweat rate will be measured using a CE marked pilocarpine iontophoresis and collection     system. The technologies for both imaging of sweat ducts and the measurement of maximal sweat     rate have been used safely and without adverse events in our prior studies involving     HED/XLHED subjects. Furthermore, this study will assess the feasibility of developing a     non-invasive screening tool that will enable detection of clinical signs of XLHED based on an     analysis of a two dimensional frontal photograph.   "
126452|NCT01629914|"     The main purpose of this study is to evaluate changes in brain functioning using an MRI     machine following mindfulness meditation training.   "
126453|NCT01629901|"     This is a prospective, non-randomized study designed to generate preliminary data to assess     the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral     blood flow on normal healthy volunteers.   "
126454|NCT01629888|"     The purpose of this study is to investigate the safety of consumption of three times the     standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.   "
126455|NCT01629875|"     The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in     moderate to severe glabellar line patients.   "
126456|NCT01629862|"     The investigators will examine the possible synergistic effects of obstructive sleep apnea     (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part     investigation:        -  A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy          controls.        -  A three-month randomized placebo-controlled trial of continuous positive airway pressure          (CPAP) in subjects with OSA+DM.   "
126457|NCT01629849|"     To investigate safety, tolerability, pharmacokinetics including posology, and     pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic     subjects   "
126460|NCT01629797|"     Acne vulgaris is a chronic inflammatory disorder of the skin in the pilosebaceous unit of the     hair follicle, associated with oil production. It is found across skin types and is present     in 85% of adolescents, representing a large affected population. Because of the universal     nature of the disease, 36.3% of acne patients come from backgrounds other than Caucasian.      The purpose of this study is to examine patient knowledge about acne in different populations     and to assess the effectiveness of a teaching intervention on acne knowledge. The     investigators aim is to better understand and subsequently reduce any potential health     disparities within the minority populations.      This project will evaluate differences in acne knowledge between different ethnic groups, and     the efficacy of an educational intervention. Subjects will first complete a survey evaluating     their knowledge of acne and how acne affects them psychosocially before an educational     intervention. Immediately following the intervention, the patient's knowledge of acne will be     evaluated again. Finally, two months after the intervention, a phone call will be made     evaluating their retention of the education materials and their quality of life related to     psychosocial effects of acne. Investigating this educational intervention and any current     disparities in acne education and understanding will better allow us to educate and treat     acne patients in the future.   "
126461|NCT01629784|"     Studies have shown that there are significant differences in severity and outcome of lupus in     patients of colored skin compared with Caucasians. There are many factors that lead to this     discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors.     Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with identifiable     triggers. One of the most aggravating triggers in CLE is sun exposure. The investigators     hypothesize that there are disparities in knowledge about photoprotection, leading to poorer     outcomes in minority ethnic groups. This study aims to assess knowledge of risk factors and     triggers, especially sun exposure, and the effects on quality of life of Caucasian and     minority populations, by conducting an assessment survey and subsequent teaching intervention     on appropriate skin protection techniques including appropriate sun screen application, and     use of sun-protective clothing. After three months a survey to evaluate knowledge retention     about and the application of the educational intervention will be conducted.   "
126462|NCT01629771|"     According to the World Health Organization, lymphatic filariasis, a mosquito-borne parasitic     disease, is the second leading cause of disability worldwide. Across 81 countries,     approximately 120 million people are infected with the disease, and of those infected, an     estimated 40% reside in India alone. The most disfiguring symptoms of lymphatic filariasis,     elephantiasis and lymphedema, cause long-term suffering in patients who are then often     embarrassed or even rejected from their communities. Because of the disease's debilitating     physical and social effects on patients, this study will explore the intersection of     disability and health-related quality of life (HRQoL) in lymphatic filariasis patients in     India. Specifically, HRQoL and disability in lymphatic filariasis subjects and age- and     gender- matched control subjects will be compared. Two HRQoL tools , the general Dermatology     Life Quality Index (DLQI) and a disease-specific instrument developed by a dermatology group     in India will be used to gauge HRQol. In addition, the demographic and disease-specific     factors associated with HRQoL and disability in filarial lymphedema subjects will be     identified.   "
126463|NCT01629758|"     The purpose of this study is to determine whether the combination of the 2 drugs being     investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the     clinical benefits of two different schedules of the combination.   "
126464|NCT01629745|"     RATIONALE: Testing for minimal residual disease in blood samples from patients with acute     lymphoblastic leukemia may help doctors plan better treatment.      PURPOSE: This research trial studies a genetic test in detecting minimal residual disease in     samples from younger patients registered on COG-AALL08B1 trial.   "
126465|NCT01629732|"     The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir     (DCV) when given in combination with or without Ribavirin   "
126466|NCT01629719|"     Phase III clinical study, two samples, with assessor blind for the purpose of evaluating the     efficacy and safety of the superiority of the use of barium sulphate 66.7% w/v (Opti-bar) as     a contrast X-ray (X-ray).   "
126467|NCT01629706|"     The purpose of the study is to investigate the corneal epithelial cell response associated     with lens wear that results in solution-induced corneal staining (Phase1) and to determine     the cell appearance in symptomatic and asymptomatic contact lens wearers (Phase 2).   "
126468|NCT01629693|"     The purpose of this study is to evaluate differences in the comfort at the end of the month     between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft     contact lens wearers.   "
126469|NCT01629680|"     A number of common eye diseases such as age-related macular degeneration and glaucoma are     associated with ocular perfusion abnormalities. Although this is well recognized there is not     much possibility to improve blood flow to the posterior pole of the eye in these diseases.      For many years, moxaverine has been used in the therapy of perfusion abnormalities in the     brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the     drug, but also on the rheological properties of red blood cells. In two recent studies the     investigators have shown that intravenous moxaverine increases choroidal and retrobulbar     blood flow in healthy young subjects, in elderly people with healthy eyes and in patients     with eye diseases associated with hypoperfusion. The present study aims to investigate,     whether ocular blood flow is also improved after oral administration of moxaverine.   "
126470|NCT01629667|"     To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function     in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic,     progressive, irreversible, and usually fatal lung disease of unknown cause.   "
126471|NCT01629654|"     Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke     fatigue is related to poor neurological recovery, low level of activities of daily living,     decreased quality of life and may possibly affect the ability to return to work. Little is     known about strategies addressing post-stroke fatigue and their effectiveness.      Aim: to develop, test and evaluate a health promotion program based on strategies addressing     poststroke fatigue.   "
128039|NCT01609140|"     The purpose of this study is to evaluate the safety and cholesterol lowering effects of     MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a     high risk of cardiovascular events and LDL-c levels well above goal.   "
126472|NCT01629641|"     The purpose of this study is to determine the test-retest and inter-rater reliability and     concurrent validity of two iPhone goniometric applications in the measurement of active     shoulder external rotation as compared to a standard manual goniometer. The scientific     hypotheses for this study are as follows:        1. There will be significant Pearson correlations (>.8) to demonstrate test-retest          reliability for each of the tools between the 1st and 2nd round of testing as assessed          by novice testers.        2. There will be significant intra-class correlation coefficients (>.8) to demonstrate          inter-rater reliability between the novice tester and the experienced tester for each of          the three tools.        3. There will be significant Pearson correlations (>.8) to demonstrate concurrent validity          between the standard goniometer and the photo capture application, the standard          goniometer and the accelerometer-based application and the photo capture application          with the accelerometer-based app. as assessed by novice testers.   "
126473|NCT01629628|"     This study will be a prospective, open label, randomized, comparative study. Comparing the     efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in     maintaining remission of post-operative CD patients, with a high risk of disease recurrence.      Patient assessment for efficacy will be conducted through interval endoscopic surveillance at     24 and 52 weeks.      Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be     re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude     therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks.      The investigators expect a substantial increase in both endoscopic, as well as clinical     remission rate in patients on adalimumab therapy.   "
126474|NCT01629615|"     The purpose of this study is to evaluate the clinical activity of BKM120 in patients with     metastatic triple-negative breast cancer.   "
126475|NCT01629602|"     Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss     of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a     challenge problem. To resolve this problem, we combined the nerve branch with the boomerang     flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For     comparison, we also collected a consecutive series of 32 patients with similar injury in the     finger treated using a cross finger flap and a secondary free nerve graft.   "
126476|NCT01629589|"     The aim of this study is to describe immunogenicity of a single booster dose of Adacel     vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.      Primary objective:        -  To describe seroprotection rates against tetanus and diphtheria in subjects randomized          to receive either Adacel or Boostrix vaccine.      Observational objectives:        -  To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean          antibody concentrations (GMCs) in subjects randomized to receive either Adacel or          Boostrix vaccine.        -  To describe booster response rates against tetanus, diphtheria, and pertussis in          subjects randomized to receive either Adacel or Boostrix vaccine.        -  To describe the rates of adverse events (AEs) immediately post-vaccination, and the          rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with          Adacel or Boostrix vaccine from Visit 1 through Visit 2.   "
126477|NCT01629576|"     Investigate whether economic incentives help obese individuals to lose weight.   "
126478|NCT01629563|"     This is a Phase III, multicentre, randomized, double-blind, parallel group, long-term study     investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment     of uterine myoma. The target population is composed of pre-menopausal women with symptomatic     uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to     assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg     doses on uterine bleeding, myoma size, pain and quality of life.   "
126479|NCT01629550|"     Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them     are avoidable and can be prevent by improving aseptic practices during catheter insertion and     maintenance. Indeed, the main route of catheter contamination for short-term catheters is the     insertion site. Consequently, the quality of skin disinfection is the most effective     preventive measure to reduce the incidence of these infections.      This aim of the present study is to compare four strategies of skin disinfection to determine     whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone     iodine in reducing catheter infection and to assess whether a detersion phase prior to     disinfection reduces catheter colonization as compared with no detersion.   "
126480|NCT01629537|"     Post Traumatic Stress Disorder (PTSD), is a devastating condition which causes distress or     impairment in social, occupational or other important aspects of functioning. The occurrence     of PTSD in the military is on the rise. This has significantly impacted military members,     their families, and society as a whole. According to an expert panel convened by the     Institute of Medicine in 2007, the effectiveness of most currently employed PTSD therapies is     low. Safe and effective treatments are urgently needed. The specific aim of this     investigation is to evaluate the effectiveness of a novel approach to relieve PTSD symptoms,     utilizing a procedure commonly used in pain management, a Stellate Ganglion Block (SGB) with     local anesthesia. Male soldiers experiencing moderate to severe symptoms of PTSD will be     recruited for evaluation of Stellate Ganglion Block with local anesthesia as an intervention     for PTSD treatment. Participants will be randomized to receive either the SGB with local     anesthesia to C6 tubercle or a sham procedure involving a subcutaneous saline injection to     the neck. The PTSD symptoms before and after the procedure will be measured using a     comprehensive clinician-administered scale, self-report measures, objective measures of     cognitive ability, and physiologic reactivity measures. Subjects will undergo assessment     prior to the procedure, one week following the procedure, one month and 3 months following     the procedure. Patients receiving sham injections will be allowed to cross over to the     treatment group. Based on published case reports of Lipov et al in Chicago and Mulvaney et al     from Walter Reed Medical Center, who utilized this technique to successfully treat soldiers     with combat-related PTSD, we predict that the use of Stellate Ganglion Block will result in     reduction of PTSD symptoms as measured by clinician-administered scales, self-report     measures, objective measures of cognitive ability, and physiologic reactivity measures,     leading to a significant and lasting reduction of PTSD symptoms.   "
126481|NCT01629524|"     Hypothesis of this study is that increased immunity of primary tumor affects the increased     number of lymph node retrieved. This study investigates whether immunity-related cytokine     expression on primary tumor, colonic mucosa, and serum is associated with the number of lymph     node retrieved in colorectal cancer patients.   "
126527|NCT01628926|"     -  To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in          order to confirm clinical value of SPM 962.        -  To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.        -  To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.   "
126483|NCT01629498|"     The goal of this clinical research study is to learn if the dose of radiation to the tumor     but not the surrounding healthy tissue could be increased by using intensity-modulated photon     therapy (IMRT) or intensity-modulated proton beam therapy (IMPT).      In Phase I of the study, researchers want to find the highest tolerable dose of IMPT or IMRT     that can be given to the tumor.      In Phase II, researchers want to learn if IMPT can help to control the disease compared with     standard proton therapy when both are combined with standard chemotherapy. Participants will     also receive standard chemotherapy. Proton therapy and photon therapy are types of radiation     therapy that are designed to use a beam of proton or photon particles (similar to getting an     x-ray) to send radiation inside the body to the tumor.      In IMPT and IMRT, the amount or strength of the protons or photons will be adjusted according     to the size, shape, and thickness of the tumor. In this study, the tumor will receive a     higher dose by adjusting the energy and scanning time of the protons or photons, which is     called simultaneous integrated boost (SIB). The treatment will be done with image guidance.     This newer type of radiation is designed to give a higher than standard dose of treatment to     the tumor. It is also designed to focus the treatment on the tumor to avoid affecting the     healthy tissue around the tumor as much as standard treatments.   "
126484|NCT01629485|"     The investigators will perform a randomized controlled trial with a stratified-block design     to compare the effect of the part versus whole task simulation training for TEP repairs.   "
126485|NCT01629472|"     There is some evidence that suggests that economic empowerment and challenging gender     inequalities and prevailing ideas on masculinities will lead to a decrease in levels of     partner violence. However, there is still a gap in our understanding of what elements are     required. This project evaluates whether participation within a savings group and a     discussion group confronting gender norms will lead to an increase in women's individual     agency and decision-making ability that will improve their economic independence and decrease     intimate partner violence in their homes.   "
126486|NCT01629459|"     Barth syndrome (BTHS) is a disorder that is characterized by heart failure, exercise     intolerance and skeletal muscle weakness. Preliminary evidence demonstrates that endurance     exercise training does not significantly improve exercise tolerance in BTHS. Because     endurance exercise training targets a metabolic pathway that is adversely affected by BTHS,     the investigators hypothesized that resistance training may improve exercise tolerance in     BTHS because this type of training targets a different metabolic pathway than does endurance     exercise. Therefore, the overall objective of the pilot/feasibility/proof-of-concept proposal     is to collect preliminary data on the following hypothesis: Supervised resistance exercise     training (3x/wk, 45min, 12 wks) will improve exercise tolerance, heart function, muscle     strength and quality of life, and will be found safe in adolescents and young adults with     BTHS.   "
126487|NCT01629446|"     The purpose of this study is to see how lofexidine (investigational study formulation drug)     is absorbed, broken down, and removed from the body. To do this, a special form of the study     drug will be used that has a radioactive carbon atom attached. Blood, urine, and feces     samples will be collected at different times to measure the amount of the study drug and     radioactivity they contain. The amount of radioactivity you will be exposed to is less than     the amount of radiation from a regular X-ray.   "
126488|NCT01629433|"     In the last years, botulinum toxin type A (onab/A) has been increasingly used as a treatment     option for overactive bladder symptoms in patients affected by either neurogenic and     idiopathic detrusor overactivity (DO). How onab/A injected into the detrusor muscle improves     overactive bladder symptoms in neurologic patients has been only partially investigated.Some     evidence suggested that the neurotoxin probably reduces detrusor muscle contraction blocking     detrusor muscle cholinergic innervation. However, recent experimental observations indicated     that onab/A determines more complex effects on bladder activity acting on afferent     innervations as well as on the efferent one. Only few experimental studies have investigated     the activity of onab/A on bladder afferent nervous transmission. Experimental studies in     animals showed that Nerve Growth Factor (NGF) elicits increased sensation, urgency and DO.     Although there are some evidence on the ability of onab/A to improve DO and to reduce bladder     and urinary content of NGF, how onab/A influences NGF expression and the expression of TrKa,     p75 and TRPV1 receptors is still unclear. The hypothesis is that onab/A reduces NGF bladder     tissue levels and in the same time it modulates the gene expression of NGF associated     receptors (TrkA, p75 and TRPV1).   "
126489|NCT01629420|"     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with     endometriosis.   "
126490|NCT01629407|"     This is an epidemiological, non-interventional, prospective study to collect data on glaucoma     progression in a routine setting. Patients may receive treatment at the discretion of their     physician per local standard of care.   "
126491|NCT01629394|"     Postoperative residual curarization in the post anaesthesia unit has been associated to     complications involving respiratory function and impaired laryngeal and pharyngeal muscles'     function. Speed of reversal of neuromuscular blockade after administration of sugammadex     versus neostigmine has been studied, but up to date no data are available concerning     continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in     morbidly obese patients undergoing weight loss surgery. The investigators' aim in this     prospective, double-blinded study was to compare train of four ( TOF ) values, the presence     or absence of clinical criteria of postoperative residual curarization , the dose     requirements and the side effects of sugammadex and neostigmine for the reversal of     rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open surgery     for morbid obesity.   "
126528|NCT01628913|"     This was a multicenter, open label, randomized phase II study to evaluate the efficacy and     safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate     grade pancreatic neuroendocrine tumor (pNET).   "
126558|NCT01628523|"     Despite its life-saving potential, the mechanical ventilator has great potential to do harm.     Despite years of research, the mortality in acute lung injury (ALI) remains very high.     Treatment options after ALI onset are very limited, therefore prevention may be the best     option. Unfortunately, the emergency department has not been studied with respect to     mechanical ventilation practices, and its contribution to ALI is unknown. The investigators     hypothesize that mechanical ventilation is frequently used in the ED and for a variety of     reasons, and that ED mechanical ventilation has an effect on long term outcomes.   "
126492|NCT01629381|"     Study Objective: To assess the value of Rivaroxaban for the prevention of venous     thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of     reference.      Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of     the type and duration of the procedure, will be eligible for the study.      Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two     arms:        -  (R-7d) Rivaroxaban (10 mg od os) for 7 days        -  (PL-7d) Placebo for 7 days.      Follow-up: 3-month period after the randomization      Standard of Reference:Placebo will be the standard of reference in accordance to     international guidelines      Study length May 2012-December 2012      Total patients number: 500 patients      Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at     least one of the following events, objectively proven (by means of CCDU; multi-slice chest     TC-angio; autopsy, if necessary, or clinical ground):        -  All-cause mortality        -  Symptomatic VTE        -  Asymptomatic proximal DVT      Secondary Efficacy End-point:      • Combined incidence of all DVT plus symptomatic PE      Primary Safety End-point: Incidence of major bleedings.      Secondary Safety End-point: Overall incidence of bleeding   "
126493|NCT01629368|"     This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on     the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a     single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a     cross-over design. The anticipated time on study treatment is 40 days.   "
126494|NCT01629355|"     The purpose of this study is to study the predictive value of SensoDetect-BERA as a     diagnostic tool in clinical practice for schizophrenia and bipolar disorder.   "
126495|NCT01629342|"     STANDARDIZED PHYSICAL ACTIVITIES MEASURED BY ACCELEROMETERS Background and aims: Physical     activity may be assessed by several different methods. However, the use of accelerometers is     the most direct method available for real-time measurements. The piezoelectric element of     accelerometers records an electric voltage during movement which is then transcribed to     Activity Counts (AC). Few studies have used Actical accelerometers to assess standardized     physical activities and most of these were not applicable to patients in a hospital setting.     No previous studies have applied Actical accelerometers to the wrists or ankles during     standardized activities. The aim of this study is to record AC during different standardized     activities frequently done by patients hospitalized for acute ischemic stroke.      Methods: Patients discharged since February 2012 after a transient ischemic attack have been     invited to participate in the study scheduled for June-September 2012 (nexpected=25). All     participants wear 5 accelerometers (Actical), one at each wrist and ankle and one over the     hip. Standardized physical activities include:        -  treadmill walking (5 minutes, 1 and 4km/h)        -  staircase walking (1 floor, normal pace)        -  cycling with fixed load (5 minutes)        -  standing up from sitting position and sitting down again (x5)        -  standing up from supine position        -  turning from left to right and back while lying in bed        -  raising outstretched arm 90° (x5, standing position)        -  eating (5 minutes, sitting position)        -  drinking a glass of water        -  sleeping (6 hours)   "
126496|NCT01629329|"     The objective of this randomized, double blind study is to demonstrate that one dose oral     excedrin migraine (acetaminophen, aspirin and caffeine) is not inferior when compared to     one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the     emergency department.   "
126497|NCT01629316|"     Purpose: The purpose of this study is to determine if a comprehensive intervention supporting     seek-test-and-treat results in a significant reduction in the potential for HIV-infected     prisoners to transmit their virus after release from prison.      Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT     (imPACT) intervention on viral load 24 weeks following prison release.      Aim 3: Describe and model secondary outcomes, comparing them between sTNT and TNT-imPACT     study arms. These outcomes include post-release HIV transmission risk behaviors, incident     STIs, adherence to ART, medical care appointments, emergence of ART resistance mutations, and     predicted HIV transmission events.   "
126498|NCT01629303|"     Subjects with refractory chronic constipation are offered two conventional therapeutic     strategies: either medical treatment, either surgery (in the case of medication failure).     Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the     sacral nerve modulation. This procedure consists in stimulating the nerves which control the     contractions of the colon and so the defecation phenomenon. Several open trials have     suggested that sacral nerve modulation may be effective in reducing constipation and related     symptoms. The aim of this randomized clinical trial is to assess the efficacy of the sacral     nerve stimulation in patients with constipation.   "
126499|NCT01629290|"     This study will be a cross-over single blinded clinical study to evaluate the in vitro     fluoride release of three different brands of 5% NaF varnish. The goal of this study is to     determine if different formulations of varnish lead to differing amounts of fluoride release.     Despite their similar concentrations of NaF (5%), some in vitro data have suggested that they     may differ in the amount of fluoride release. Determining fluoride release of these varnishes     in vivo is important in assessing both the safety and efficacy of the product.   "
126500|NCT01629277|"     The ultimate goal of the investigators ongoing research is the development of a closed-loop     system for insulin delivery, which can help people with type 1 diabetes (T1D) attain a tight     glucose control avoiding the risk of hypoglycaemia. The main components of the system are a     continuous glucose monitor (CGM), an insulin pump and a computer-based 'model-predictive     algorithm', which computes the amount of insulin to be given by the insulin pump according to     the CGM values. In the studies performed thus far the efficacy and safety of closed-loop     glucose control was evaluated both overnight and over a prolonged period of time including     the day-time in children and adolescents with T1D. The results showed that closed-loop     improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the     conventional insulin pump therapy.      The objective of the current study is to test the performance of closed-loop further, by     evaluating the system during common non-compliant behaviours in the administration of meal     insulin doses in adolescents with T1D. This will pave the way for a more comprehensive use of     closed loop systems to control glucose levels in T1D under various real-life mimicking     common circumstances. The present study adopts an open-label, randomised, 2 period cross-over     design whereby closed-loop insulin therapy will be compared with the conventional insulin     pump therapy in 12 adolescents with T1D.      Participants aged 12 to 18 years will be randomised for two 24 hour studies in a clinical     research facility, during which glucose levels will be controlled by either the     computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump     therapy (control arm). On both occasions, participants will under-estimate and omit the     meal-related insulin dose for the evening-meal and lunch, respectively. The study will take     place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge with participants     recruited from paediatric diabetes clinics in England.   "
126501|NCT01629264|"     The intraocular pressure in the human bulbus requires that the wall of the eye shows a     certain (bio)mechanical strength. The human cornea represents the anterior portion of this     wall. Since several years, there is a growing interest in the ophthalmological community for     identifying factors modulating the biomechanical stability of the human cornea. Reasons are     twofold: advances in keratoconus research and the increasing numbers of refractive laser     surgery procedures with (correspondingly) increasing numbers of complications due to     non-respecting the limits of corneal biomechanics.      There is evidence that oestrogen, but also thyroïd hormone changes have a major impact on     corneal biomechanics. A number of recent observational studies have reported on keratoconus     and refractive laser surgery patients with decompensating biomechanics during pregnancy.      Both hormones also show physiological changes during pregnancy and little is known about the     impact of these physiological changes on the human cornea.      The aim of this study is to establish baseline values for physiological changes in the human     cornea during pregnancy.   "
126502|NCT01629251|"     The main focus of our research is the development of a closed-loop system for glucose control     in people with type 1 diabetes. After having demonstrated the safety and efficacy of     overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the     daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing can     be associated with the occurrence of postprandial hypoglycaemia, thus representing a     confounding factor of hypoglycaemia free glucose control during the day. A further     investigation is needed to evaluate alternative strategies for prandial insulin dosing. We     will study eight adolescents with type 1 diabetes during closed-loop insulin delivery     combined with either standard or reduced insulin doses with the meals, in a randomised     crossover design. Stable glucose isotopes will be administered to collect data for modelling     of glucose turnover around the meals, during daily activities and overnight.      The information provided by the use of glucose isotopes would be very helpful to increase our     understanding of the physiology of glucose turnover and to facilitate the development of an     improved control algorithm. Ultimately this study will help with the development of a     closed-loop system to match insulin infusions to change in glucose levels in real life     conditions.   "
126503|NCT01629238|"     The purpose of this study is to describe the cardiovascular risk profile in subjects who     consume a marketed drinkable low fat fermented milk enriched with plant sterol.     Investigations are lead prospectively and retrospectively among adults enrolled from general     practitioners' database.   "
126504|NCT01629225|"     The purpose of this study is to investigate the association between GRK4 polymorphisms and     essential hypertension in southwestern Han Chinese and test whether these polymorphisms were     associated with the changes in blood pressure in patients with essential hypertension treated     with angiotensin II Type antagonist candesartan.   "
126505|NCT01629212|"     The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and     Octylonium bromide in the Treatment of Irritable Bowel Syndrome.   "
126506|NCT01629199|"     The purpose of this clinical trial is to evaluate the safety and efficacy of rhEGF     (recombinant human Epidermal Growth Factor) in diabetic foot ulcer patients with uncontrolled     diabetes mellitus.   "
126507|NCT01629186|"     The nasopharyngeal oxygen (NPO) with Nose-close (NC) and Abdomen-compression (AC) technique     may use for support or rescue asphyxiated infants during Flexible bronchoscopy.   "
126508|NCT01629173|"     The aim of the study was to investigate the effectiveness of dynamic impression insoles on     plantar pressure and pain reduction. A dynamic impression insole was made by sequential     padding with Plastazote and P-cell under daily walking compression. The pain levels and     plantar pressure with the use of dynamic impression insole were assessed and compared with     7-mm Ethylene Vinyl Acetate (EVA) control, 9-mm uncompressed Plastazote and custom molded     insoles. Plantar pressure was measured by a Pedar-X mobile system, and pain level was     assessed using a Visual Analog Scales.   "
126509|NCT01629160|"     The purpose of this study is to evaluate feasibility of using new technologies to     characterize ventricular wall motion in patients indicated for mapping and ablation     procedures. Echo will be performed preoperatively and patients will receive a 1-month     followup telephone call.   "
126510|NCT01629147|"     Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in     children 4-10 years of age.   "
126511|NCT01629134|"     A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine     in the lips.   "
126512|NCT01629121|"     The hypothesis was that the implementation of a Safe Kids East Central brain injury     prevention program targeting children and caregivers admitted to the Georgia Health Sciences     University Children's Medical Center is feasible and that short-term treatment effects of     injury prevention education on the child or adolescent and the caregiver will increase     bicycle helmet use.   "
126513|NCT01629108|"     Background:      - Researchers at the National Institutes of Health give many tests of hearing and balance.     These tests can help detect problems that affect hearing or balance. It is important to know     exactly how healthy people perform on each of these tests. This information will indicate     when a test result is normal and when a test result shows a problem. Researchers also want to     determine the best methods for each test.      Objectives:      - To test different types of hearing and balance tests, and collect information on normal     values for each test.      Eligibility:      - Healthy volunteers between 5 and 70 years of age.      Design:        -  This study will require a single visit to the National Institutes of Health Clinical          Center. It will include both screening tests and study tests of hearing and balance.          Sometimes, a second visit may be required if a test is designed to measure the same          thing on 2 different days. Each visit will last between 2 and 5 hours, depending on the          number of tests scheduled per visit.        -  Participants will have a physical exam and medical history. They will also have basic          tests to check for normal hearing and balance.        -  Participants may have different hearing tests, including the following:        -  Auditory Evoked Potentials to study how the ears and brain handle sound information.        -  Auditory Processing Tests to study how a person processes complex sounds like speech in          background noise.        -  Tests of middle ear and inner ear function.        -  Participants may have different balance and inner ear tests, including the following:        -  Balance test on a tilting platform.        -  Different tests to measure how well the eyes, ears, and brain work together to help          maintain balance.        -  Treatment will not be needed as part of this study.   "
126555|NCT01628562|"     It was hypothesized that the use of esmolol as an alternative to remifentanil with     sevoflurane inhalation anesthesia during intracranial surgery, could provide better     hemodynamic conditions and cause lesser side effects in the perioperative period. It was the     main objective of this study to compare the effect of esmolol and remifentanil on the     incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The     comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes     were the secondary objectives.   "
126514|NCT01629095|"     Background:      - Non-alcoholic fatty liver disease is the most common form of liver disease in the United     States. It includes many conditions. Researchers want to study fatty liver disease by looking     at people who have liver cirrhosis. They also want to look at people who are or were listed     for liver transplants. Genetic studies may provide more information on the causes of these     conditions.      Objectives:      - To study possible genetic causes of non-alcoholic fatty liver disease.      Eligibility:      - Individuals of any age who have non-alcoholic fatty liver disease and related conditions.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will provide a blood sample for genetic testing. Liver tissue from a          transplant or biopsy may also be studied.        -  Participants may also be asked to have an imaging study of the liver. This imaging study          may be an x-ray or magnetic resonance imaging.        -  No treatment will be provided as part of this research study.   "
126515|NCT01629082|"     Background:        -  Several types of blood cancer are associated with poor outcomes including high-risk          myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute          myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for          standard treatments. New types of treatment are needed for these cancers.        -  Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in the          body. The second can alter blood supply to abnormal cells or affect how the immune          system attacks these cells. These drugs have been previously tested as treatments for          MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and          AML. Researchers want to see if these drugs are safe and effective for these types of          cancer.      Objectives:      - To test the safety and effectiveness of clofarabine and lenalidomide for people with     high-risk MDS, CMML, and AML.      Eligibility:        -  Individuals at least 18 years of age who have high-risk MDS, CMML, and AML.        -  Participants must not be candidates for standard treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and bone          marrow samples will be collected.        -  Participants will have 5 days of treatment with clofarabine. It will be given through a          vein during an inpatient hospital stay. If there are no serious side effects after the          infusion, participants will continue treatment as outpatients.        -  After 28 days, participants will have a bone marrow biopsy to check their response to          treatment.        -  After the biopsy, participants will start lenalidomide treatment. Half of the          participants will take the drug for 28 days (one treatment cycle). The other half will          take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor          treatment.        -  If there are no serious side effects and the disease does not become worse, participants          may keep taking lenalidomide at lower doses for up to 12 more cycles.   "
126516|NCT01629069|"     The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance     of a new 6 week intervention in Arizona for our transplant and cancer patients and their     care-givers, designed to improve quality of life, decrease perceived stress, and improve     medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic in     Arizona.   "
126517|NCT01629056|"     This study aims to investigate the benefit of a new impedance-based computer software     application during routine catheter ablation for atrial fibrillation, to see if this     information improves short and long term electrical disconnection of the pulmonary veins.     This study will be a single blind prospective randomised control trial in patients undergoing     AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary     vein ablation with, and parts of their ablation without tissue contact data displayed for the     doctor performing the ablation to see. The pulmonary veins will then be studied at the end of     the procedure, and at any repeat procedure in the future, to look for a difference in the     recovery rate of the ablations performed using contact data, compared to those ablations     performed without the use of this contact data. If a reduction in tissue recovery is achieved     through the use of this tissue contact data, it may lead in the future to a reduced need for     repeat ablation procedures, and better outcomes for patients.      The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the     recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing     left atrial ablation for atrial fibrillation.   "
126518|NCT01629043|"     In a recent study it was found that neurologist care for Parkinson's provides a 20% reduction     in nursing home placement, hip fracture, and death (Willis 2011). However, as the authors     recognized, the investigators don't know what it is about expert care that delivers this     benefit. The National Parkinson Foundation's Quality Improvement Initiative was designed to     identify the components of great care that yield great outcomes. By capturing demographics,     clinical interventions and outcomes over time from multiple centers across the U.S, Canada     and internationally, the best care practices from different clinics and different healthcare     systems will be analyzed.   "
126519|NCT01629030|"     The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts     as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.   "
126520|NCT01629017|"     This project allows for the systematic collection and analysis of long-term follow-up     clinical parameters in children who have received a stem cell transplant. The data collected     will assist in determining appropriate intervention and treatment plans for patients enrolled     on this study. In addition, future patients may benefit by having the ability to anticipate     problems and develop methods of prevention or early intervention.   "
126521|NCT01629004|"     The investigators hope to determine whether the addition of an FOBT kit and educational     materials to a second mailed invitation compared to a second mailed invitation alone     increases use of appropriate screening tests (FOBT for average risk or colonoscopy if     increased risk) by eligible persons within 6 months of the second mailing in:     (1)Non-responders to an initial mailed CRC screening invitation from their family physician     and, (2)Those who responded to the initial mailed CRC screening invitation and are due for     repeat screening (i.e., recall patients). In addition, the investigators will also explore     the impact of the investigators intervention in likely under-screened groups such as those     living in more remote areas of the province and those with low socio-economic status as well     as assessing the cost-effectiveness of this strategy.   "
126522|NCT01628991|"     This study is a single blind randomized clinical trial to compare the efficacy of a     behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).   "
126523|NCT01628978|"     The investigators are trying to evaluate the efficacy of ultrasonographic determination of     depth of endotracheal tube placement in infants and young children by using the pleural     sliding sign.   "
126524|NCT01628965|"     Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease     patients who are not concomitantly treated with L-dopa will be investigated with a doses.   "
126525|NCT01628952|"     This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric,     phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of     the abdominal wall during laparoscopic digestive surgery.   "
126529|NCT01628900|"     The prevalence of acute pyelonephritis (PNA) is 60-75 000/year. They are traditionally     classified as uncomplicated (60-65%) and complicated. If it is assumed that the uncomplicated     PNA can be treated as outpatients with a cure rate of over 80%, the second group is very     heterogeneous. Some patients are severely infected. But others, despite an older age,     structural urologic abnormalities or a controlled history, have no risk factors and can be     simply managed. The investigators propose to reclassify the PNA into 3 categories:     uncomplicated PNA (PNA-1), the PNA of moderate severity (PNA-2), the major PNA (PNA-3) to     test whether the PNA-2 can benefit from the same outpatient care that the PNA-1. The     existence of biological markers of the severity of bacterial infections would further support     a tailored approach. The pro-adrenomedullin (pro-ADM), successfully tested to identify severe     community acquired pneumonia, is a an interesting candidate.   "
126530|NCT01628887|"     This clinical trial studies a supportive education program for Latina breast cancer     survivors. The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast     cancer survivors know what to expect after completing breast cancer treatment and prepare     them to cope with cancer related survivorship issues   "
126531|NCT01628874|"     The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection     system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a     topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with     1% lidocaine will provide local anesthesia that is comparable to that of a topical anesthetic     agent (EMLA cream) when performing lumbar punctures in children.   "
126532|NCT01628861|"     The purpose of this study is to determine whether an on-screen prompt put on the work     computer every 30 minutes is effective in getting office workers to reduce prolonged periods     of sitting at work.   "
126533|NCT01628848|"     The primary objective of this study is to investigate efficacy and safety of SPM 962 in     advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study     following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg     (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also     to be investigated with distribution of the maintenance dose and accumulated response rate of     efficacy.   "
126534|NCT01628835|"     The study is a randomized, single-blinded, controlled intervention trial to compare the     effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for     Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.   "
126535|NCT01628822|"     The main objective of this protocol is to measure the improvement of the overall situation of     patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment     relaxation.      Secondarily,is to evaluate the evolution of physical variables, psychological and social     improvement of the quality of life. To evaluate the evolution of drug consumption   "
126536|NCT01628809|"     The purpose of this study is to determine the effects of a three-day mindfulness meditation     retreat (vs. a three-day relaxation retreat) in stressed, unemployed, community adults on     brain function, brain structure, and overall health and immunity.   "
126537|NCT01628796|"     Is it possible to improve the accuracy of injection into the acromio-clavicular joint with     the use of ultrasound?   "
126538|NCT01628783|"     In this study the investigators use clinical, biological and imaging markers to develop     predictive markers for remission from depression. The investigators compare individuals who     have received placebo to individuals who have received 10 mg of escitalopram for one week. In     this double-blind, randomized study the investigators a) compare the groups to observe the     short-term effects of escitalopram and b) study the predictive value of these observations     with respect to remission. Measures include, but are not restricted to, limbic emotional     reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical     memory.   "
126539|NCT01628770|"     The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron     preparation will be equally effective in correction of postpartum iron deficiency anemia.   "
126540|NCT01628757|"     Cervical cancer is one of the major health problems for chinese women. Besides surgery and     radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many     studies.      However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic     effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic     burden, but also more importantly save time to take more suitable treatments.      This study is undertaken to build a model combine both clinical and genetic factors to     predict the effects of neoadjuvant chemotherapy.   "
126541|NCT01628744|"     In adult, the prevalence of mycobacterial infections is increased with age is largely     unknown. IFN-gamma-IL-12/23 axis or NF-kappaB pathways might also plays crucial roles in     adult against mycobacteria. Based on this hypothesis, the investigators had applied a     functional assay to these pathways in patients with mycobacterial infection.   "
126542|NCT01628731|"     This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide     continuous infusion in total urine output production during the first 24 post operative     hours.   "
126543|NCT01628718|"     The primary objective of this randomized controlled non-inferiority trial is to determine     whether or not Adaptive Disclosure (AD), a new combat-specific psychotherapy for Post     Traumatic Stress Disorder (PTSD), is as least as effective as Cognitive Processing Therapy,     cognitive only version (CPT-C), in terms of its impact on deployment-related psychological     health problems (specifically PTSD and depression) and functioning.   "
126556|NCT01628549|"     To evaluate the safety and effectiveness of 3 strengths of P005672 compared to placebo for     the treatment of moderate to severe facial acne.   "
126557|NCT01628536|"     The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will     reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a     pre-operative setting.   "
126559|NCT01628510|"     The purpose of this study is to investigate the developmental effects of two different types     of positioning used with premature infants in the neonatal intensive care unit.   "
126560|NCT01628497|"     This study is looking at the difference in exhaled nitric oxide levels in patients with and     without laboratory evidence of filariasis.   "
126544|NCT01628705|"     Background: Obesity is a chronic degenerative disease, considered as cardiovascular risk     factor, characterized by systemic inflammation and high levels of oxLDL. Clinical studies     have suggested that drink green tea could improve these complications.      Objective: Analyze the effect of a moderate-fat diet complemented with green tea on oxLDL,     fat mass and TNFa in obese women.      Design: Randomized, controlled clinical trial. Obese women, without other     chronic-degenerative disease were divided using a computer-generated random sequence: control     group (CON) with n=32, and intervention group (INT) with n=32; and were instructed to consume     a moderate-fat diet, and INT group was instructed to complement the diet with green tea.     Anthropometric and biochemical measurements were performed, and oxLDL and TNFa s levels were     determined by ELISA. All parameters were realized at baseline and in the 1st, 2nd and 3rd     months post-intervention. TNFa mRNA expression was determined by real-time RT-PCR (basal and     final). The changes on lipid profile, oxLDL, fat mass and TNFalpha expression were reported     of the comparison between basal and final time points. The statistical analysis was performed     with SPSS software.   "
126545|NCT01628692|"     The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir     with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who     are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.   "
126546|NCT01628679|"     Hypothesis:        1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor          control, increase self efficacy, improve sexual function and decrease pain          catastrophizing behaviour in women with provoked vulvar vestibulodynia.           This study will look at specific physiotherapy treatment interventions to see if they          decrease pain, improve pelvic floor motor control, increase self efficacy, improve          sexual function and decrease pain catastophizing behaviour. Participants will fill out a          questionnaire on their pain symptoms and complete standardized scales prior to starting          treatment and after 4 sessions to determine change due to interventions.        2. A combination of physiotherapy, group educational sessions and group cognitive          behavioural therapy will have better outcomes than physiotherapy alone.      Results of physiotherapy intervention alone will be compared to results of those treated with     physiotherapy, group educational sessions and group cognitive behavioural therapy at a     separate treatment centre. Physiotherapy interventions and outcome measures are the same     between both groups.      Justification:      Standard treatment is hard to identify as many approaches are taken, none with any evidence     to support them. This study aims to look at specific techniques (pelvic floor coordination     and relaxation exercises, education on female sexual response and pain pathophysiology     education) to see if there is a benefit.   "
126547|NCT01628666|"     The goal of the study is to compare whether a center-wide policy of incremental antibiotic     therapy will reduce CIED infection rate compared to a policy of conventional antibiotic     prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics     used are approved for use and readily available.   "
126548|NCT01628653|"     The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced     Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly     individuals with mild cognitive impairment (MCI).   "
126549|NCT01628640|"     This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis     virus expressing interferon beta in treating patients with liver cancer or solid tumors with     lesions that have spread to other parts of the body and do not respond to treatment. The     study virus has a gene inserted into it which will allow production of interferon beta, which     is a substance that will restrict the spread of the virus to tumor cells and not healthy     cells. It will also have some independent anti-cancer activity. Although the primary goal of     this study is to evaluate the safety of delivery of this viral agent to people, patients may     benefit clinically by having shrinkage or stabilization of their tumor or reduction in their     cancer related symptoms (e.g., pain). Funding Source - FDA OOPD.   "
126550|NCT01628627|"     Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated     electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in     patients with diabetes mellitus.   "
126551|NCT01628614|"     This is an observational study and will evaluate IOP reduction in newly diagnosed patients     with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the     discretion of the participating physicians according to their clinical judgment and the local     standard of medical care.   "
126552|NCT01628601|"     This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG)     or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are     prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their     physician.   "
126553|NCT01628588|"     This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice     for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).   "
126554|NCT01628575|"     Periodontally accelerated orthodontics, also known as PAO, is a novel technique combining     alveolar corticotomy and bone grafting prior to commencing orthodontic treatment. Using this     technique orthodontic de-crowding and space closing, can be completed in 60-70% less active     orthodontic treatment time. The addition of particulated bone graft following decortication     allows for the widening of the bucco-lingual alveolar bony dimension, thus creating space for     the movement of teeth, without the creation of dehiscences, usually a negative sequel of the     standard orthodontic treatment.      Aim: To evaluate the use of the PAO technique for the treatment of 20 adult patients 1 year     post orthodontic treatment.      Methods: 20 periodontally healthy adult patients requiring orthodontic treatment were     admitted in the departments of Periodontics and Orthodontics in Hadassah Medical Center. All     patients underwent full orthodontic and periodontal examination upon admission including a     pretreatment CBCT scan. Decortication followed by grafting was made after the orthodontic     appliances have been placed. The orthodontic appliances were activated immediately after     surgery and every 2 weeks. During the 1 year follow up a periodontal and orthodontic clinical     evaluation were made, as well as a CBCT scan.   "
126573|NCT01628328|"     This study aims to examine the hypothesis of tumor cell dissemination after colonic stenting     for obstructing colorectal cancer by measuring the level of plasma circulating tumor cell     before and after the procedure of successful colonic stenting in patients.   "
126561|NCT01628484|"     The objectives of this monocentric investigator initiated exploratory clinical trial is to     optimize allergen delivery across the epidermal barrier. The cornified outer epidermal layers     represent the main barrier towards entry into the viable epidermal layers. In the latter we     aim to target the allergen for uptake by professional antigen presenting cells, called     Langerhans cells. At the same time as little allergen as possible should be delivered to the     dermis. The latter contains a high density of sensitized mast cells eliciting local reactions     and also a high density of blood vessels which could lead to systemic distribution of     allergen and therefore to systemic allergic reactions.      In birch pollen allergic individuals we will compare different methods of preparing the skin     before application of the allergen. We will subsequently apply titrated allergen doses to the     prepared skin areas to determine at which dose we start observing mast cell degranulation     manifesting as hives.      This will allow for determination of the maximal tolerated allergen dose for each skin     preparation method.      The skin preparation methods compared will be:        -  Single pricking with prick lancet (Entaco LTD., Redditch, Worcestershire, UK,          distributed by Stallergenes®).        -  Tape stripping with conventional adhesive Tape (Tesa-film®).        -  Microchanneling with Micro Needle Patch (Micro Skin System, 3M®). The methods are          strongly connected to routine diagnostics of allergies with low risk associated.      The clinical trial protocol has been submitted to the local Ethics Committee.      This comparison of skin preparation methods and the determination of the maximal tolerated     allergen dose will help us to further improve epicutaneous allergen immunotherapy, which has     the potential to make allergen specific immunotherapy not only considerably shorter and     safer, but also more convenient for patients. Skin preparation by microneedle patches is     significantly less painful than conventional injection and can be self administered. This     should help improve the acceptance of allergen specific immunotherapy, as well as treatment     compliance.   "
126562|NCT01628471|"     Lung cancer is one of the most prevalent and lethal neoplasias in the world. Currently used     chemotherapy regimens have been disappointing in improving overall survival. Decitabine is a     S-phase pyrimidine analog that induces DNA hypomethylation. This drug is currently used to     treat Myelodysplastic Syndrome ( MDS) and has been studied for the treatment of leukemia.     Genistein, is a soy extracted non-toxic isoflavone and phytoestrogen, which has been shown to     inhibit activity of cell signaling pathways, such as those driven by tyrosine kinases.     Results from in vitro experiments unambiguously demonstrated that the combination of these     two compounds induces a synergistic reduction of the multiplication of lung, colon, breast     and leukemic cancer cells. Consequently, clinical evaluation of this drug combination is     warranted in Non Small Cell Lung Cancer ( NSCLC), and it is hypothezised that this new     regimen will safely improve overall tumor response rate and cancer progression free survival.      The proposed trial is a two part study: The phase I part is an open-label, dose-escalation     evaluation in subjects with advanced solid tumors who have failed standard therapies and for     whom no curative therapeutic option exists.      A cohort of three subjects will be treated per dose level. One cycle is 28 days. Five     different, increasing dose levels ranging from 60 mg/m2 to 500 mg/m2 of IV decitabine     combined with a fixed oral dose of 150 mg BID of genistein will be tested. The Maximum     Tolerated Dose (MTD) will be determined based on the occurrence of Dose Limiting Toxicities     (DLTs).      In the phase IIa part of the study, only Stage IIIb and IV advanced NSCLC patients will be     treated at the recommended decitabine MTD dose combined with genistein. Safety and     preliminary efficacy will be assessed. It is expected that a maximum sample of 46 patients     will be enrolled in this trial.   "
126563|NCT01628458|"     The purpose of the study is to determine the safety of radiofrequency ablation of locally     advanced pancreatic cancer that can not be surgically removed with the current standard     procedures. Complications after the operation will be registered. Moreover a pain score will     be determined, length of hospital stay, chemotherapy, survival, progression free survival and     a tumour marker.   "
126564|NCT01628445|"     Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated     with improved blood glucose control, weight loss and low rates of hypoglycemia when used     alone or in combination with metformin. Liraglutide has not been extensively tested in people     with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day). Often     these patients are insulin resistant and despite using large doses of insulin are not able to     achieve glucose targets. The rationale for this study is to assess if the addition of     liraglutide in addition to usual care versus placebo can improve blood glucose levels in     people not achieving a target HbA1C of less than 7.0%.   "
126565|NCT01628432|"     The study compares the effect of bilateral salpingectomy associated with conservative     hysterectomy on ovarian function to the standard hysterectomy with conservation of both     ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications,     quality of life.   "
126566|NCT01628419|"     The purpose of the current investigation is to examine the effects of health intervention     program at the workplace on health risks for cardiovascular disease, well-being and     absenteeism at the workplace.      Participants: 1500 male and female employees from 10 different companies across Israel will     take part in the study. Age: older than 18 yrs.      Hypothesis 1: The intervention program will have positive effects on the health risks for     cardiovascular disease. For example: Will be reflected in a decrease in LDL and increase in     HDL.      Hypothesis 2: The intervention program will have positive effects on the absenteeism at the     workplace (e.g. decrease in days of sick leave per employee).   "
126567|NCT01628406|"     The investigators record all indications, treatments and outcomes from patients treated at     the Neurosurgery Department.        -  Trial with surgical intervention   "
126568|NCT01628393|"     The purpose of this study is to determine whether RPC1063 is effective in the treatment of     relapsing multiple sclerosis (RMS).   "
126569|NCT01628380|"     Aim of the Study is to compare two-years disease-free survival of Cytoreductive Surgery (CRS)     and Hyperthermic IntraPEritoneal Chemotherapy (HIPEC, CDDP+Paclitaxel) vs CRS alone in Stage     IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3     cycles of 1st line chemotherapy (CBDCA +Paclitaxel).   "
126570|NCT01628367|"     An important result of healing after tooth extraction is a reduction in dimensions of the     remaining bone at that site. This reduction of bone volume precludes successful restoration     of the space using a dental implant. Bone augmentation has shown promise in clinical reports     to reduce this loss of bone volume, thus allowing implant placement and restoration. The     purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone     regeneration around dental implants placed in fresh extraction sockets.   "
126571|NCT01628354|"     The investigators hypothesize that it is safe and effective to treat patients with choroidal     neovascularisation (abnormal blood vessels growing under the retina) secondary to causes     other than age related macular degeneration (AMD) and pigment epithelial detachments     (blisters of fluid under the retina) secondary to AMD with ranibizumab (Lucentis).      These groups of patients have to date been excluded from the multicentre trials demonstrating     significant benefit of Ranibizumab in the treatment of AMD.   "
126572|NCT01628341|"     This non-interventional study is conducted in Europe. The study is both retrospective and     prospective.      The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in     insulin-treated patients with type 1 and type 2 diabetes.   "
126611|NCT01627834|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,     crossover, oral bioequivalence study.   "
126574|NCT01628315|"     -  To examine short- and long-term value of appearance of new active lesions in predicting          extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA          (Avonex- Steroid-Azathioprine)study.        -  To explore how accumulation of cortical and SDGM atrophy over 5 years differs with          respect to the number of new active lesions or amount of disease activity, in early          relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop          sustained disability progression.        -  To examine the relationship between development of cortical and SDGM atrophy and          regional likelihood of development of new active lesions over 5 years.   "
126575|NCT01628302|"     The present prospective, randomized, crossover study is designed to investigate the effect of     salt consumption on blood pressure in hypertensive subjects.      Secondary objectives of the study are to evaluate the effect of salt consumption on blood     pressure among the subjects who are hypertensive and obese and normal according to body mass     index and to evaluate the effect of salt consumption on renin activity in hypertensive     subjects.   "
126576|NCT01628289|"     Introduction: There is no debate that people with diabetes should be screened for the     development of retinopathy which can threaten their sight. However, there is no routine     screening for retinopathy in Hong Kong at present. Many overseas countries find that they     miss a large proportion of their target population and, with reliance on co-payments for     screening, as is the case with the limited opportunistic screening at present, the     cost-effectiveness of any routine service in Hong Kong could be reduced as is predicted by     Hart's inverse care law.      Aim: This study will determine the potential cost-effectiveness of screening for retinopathy     in Hong Kong under a free system and one in which a co-payment is charged.      Methods: Primary care patients attending General Outpatient Clinics on Hong Kong Island for     their routine diabetic care will randomly be offered screening either at no charge or with     the normal co-payment of $65. Those who are willing and unwilling to be screened will be     compared for their clinical, lifestyle and socioeconomic characteristics and those unwilling     will be asked their reasons. The uptake of screening at no fee and with a payment will be     compared as will the prevalence of retinopathy in the two fee groups. Subsequent screening at     one year will be offered at the same fee and uptake again compared.      The principal analyses will (a) identify the characteristics of those willing to be screened     and reasons for not being screened (b) the uptake of screening when a co-payment is charged     compared to when it is free (c) whether there is a difference in the prevalence of     retinopathy between the group willing to pay and those who accept free screening and (d) the     uptake of re-screening in year 2.      The resulting cost-effectiveness model will use these data, the cost data collected during     the study and overseas data on benefits of treatment to model the cost-effectiveness of     screening for retinopathy in Hong Kong if it were to be offered free or with a co-payment.     This information will be important to determine the most cost-effective means of implementing     this preventative strategy to preserve sight and quality of life.   "
126577|NCT01628276|"     This trial seeks to investigate brain network changes following cognitive rehabilitation in     MS patients. The investigators hypothesize that rehabilitation interventions improve     connectivity in the brain.Novel Magnetic Resonance Imaging technique is performed to     investigate changes in brain plasticity.   "
126578|NCT01628263|"     The aim of our study is to determine the feasibility of carrying out a randomized controlled     trial (RCT) to investigate whether screening parents of children admitted to pediatric     intensive care unit (PICU) so as to target follow-up at those most at risk of developing     posttraumatic stress disorder (PTSD), is effective at reducing adverse psychological     sequelae.   "
126579|NCT01628250|"     Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery     technique to perform a resection for colon cancer. Besides, the segment of the colon     containing the tumor, the resection area should include an intact mesocolon as an envelope to     encase the possible route for metastasis. The routes include blood vessels, lymphatic drain     and etc. Such hypothesis predicts better histopathological and higher oncological results     which turns into better survival rate and better quality of life.   "
126580|NCT01628237|"     Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe     handicap for patients and represents a considerable expense for healthcare system.     Neurostimulation has currently not been validated in the treatment of back pain because of     technological limitations in implantable spinal cord stimulation (SCS). The lack of a     validated technique for back pain relief has prompted the development of newer devices,     including leads with increased number of contacts (up to 16) and various geometric     arrangements, the objective of which is to cover a larger area while attempting to extend,     steer, or focus the electric field of the stimulation within the spinal cord regions. This     led companies to design a new generation of multicolumn surgical leads that allow the     activation of longitudinal and transverse electric fields (multicolumn spinal cord     stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.      The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal     and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using     axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of     lumbar pain.      A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and     80 years old suffering from refractory neuropathic pain of radicular origin with associated     back pain will be included. Patients will be divided into two groups. One group with MSCS     during the 12 months after the new generation electrode implantation and one group with CSCS     during 6 months and MSCS between 6 and 12 months after the new generation electrode     implantation.      The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS,     back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale,     Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing     in relation to surgery and patient management.   "
126581|NCT01628224|"     This study involves two tasks. The first involves observation of patient care during     simulated aeroevacuation missions in order to gauge task saturation. The second involves     review of records from actual evacuation flights in order to determine the effects of task     saturation on patient care.   "
126582|NCT01628211|"     The purpose of this study is to evaluate whether a second-look laparoscopy, followed by     peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in     case of peritoneal carcinosis, improves the overall survival of patients who have had radical     resection of mucinous colorectal cancer.   "
126583|NCT01628198|"     Despite the development of many drug therapies designed to treat high blood pressure     (hypertension), it remains a considerable and poorly managed health, social and economic     burden. For various reasons, including the high health care costs of treatment, there are     estimates that up to 65% of patients with high blood pressure have untreated and/or     uncontrolled blood pressure (BP).      Aside from its effect on kidney function, chronic high blood pressure increases the risk for     stroke, and heart disease. It is also thought to be involved in the formation of irregular     heartbeats. This link between high blood pressure and heart health has been well described,     as has their combined effect on the aging and the obesity-battling Western world.      A recently published study (Symplicity HTN-2 trial) established the benefit of a new     treatment procedure, catheter-based renal sympathetic denervation (RSDN) for hypertension, as     having enormous potential for the treatment of patients with high blood pressure. This     multi-center trial will attempt to confirm and expand on these promising data. Patients who     enroll in the trial will be followed for 4 years.   "
126626|NCT01627639|"     The purpose of this study is to determine whether acetazolamide are effective to reduce the     length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease     (COPD) patients developing pure or mixed metabolic alkalosis.   "
126584|NCT01628185|"     Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is     recommended in the general population, however it is not always possible in patients with     altered neurological status such as sedated patients or patients with delirium. Consequently,     pain assessment is highly challenging in these ICU patients. This is a prospective     observational study assessing 3 behavioral pain scales in the ICU.      The hypothesis of this proposal is that one of the three ICU pain scales has a more important     reliability than the others. Such a scale could be recommended to be used to measure pain     intensity in ICU patients not able to communicate.   "
126585|NCT01628172|"     Despite the development of numerous drug therapies designed to treat hypertension, it remains     a considerable and poorly managed health, social and economic burden. For various reasons,     including the significant health care costs of treatment, there are estimates that up to 65%     of hypertensive patients have untreated and/or uncontrolled blood pressure (BP).      Aside from its impact on renal function, chronic hypertension significantly increases the     risk for stroke, coronary artery disease, heart failure, and vascular disease. It is believed     to be involved in the progression of cardiac arrhythmias. This link between hypertension and     cardiovascular health has been well described; as has their combined effect on the aging and     obesity-battling Western world.      The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation     in patients with treatment resistant hypertension) establishing the therapeutic benefit of     catheter-based renal sympathetic denervation for hypertension, have enormous potential for     the management of a large and challenging patient population. The proposed, multicenter trial     will attempt to confirm and expand on this promising data by conducting a double-blinded,     placebo-controlled trial.      Patients may qualify to participate in this research study if their doctor has determined     that they have drug-resistant, chronic hypertension.      Overall participation in this research study should be about 13 months which includes about 1     month to start the study procedure and 12 months of follow-up after the study procedure.   "
126586|NCT01628159|"     The purpose of the study is to collect additional safety and efficacy information on the     Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the     femoral and popliteal arteries.   "
126587|NCT01628146|"     This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye     study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic     hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.   "
126588|NCT01628133|"     The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion     affects intestinal blood flow of premature infants during feedings and if so, whether return     of normal intestinal blood flow pattern occurs within 48 hours of blood transfusion.      Abnormal intestinal responses to the feedings (insufficient postprandial blood flow increase     in order to digest given feeding volume or overall decrease of intestinal blood flow) may     predispose infants to feeding intolerance and to serious intestinal disease called     necrotizing enterocolitis (NEC).      Patent ductus arteriosus (PDA) is a relatively common heart condition found in young preterm     infants that can lead to decreased blood flow in different organs, including intestines.     Thus, the determination of the presence or absence of PDA is an important part of the study,     since it can be a relevant confounding variable.      In this study, the investigators will assess intestinal blood flow by using sonogram to     measure velocity through the superior mesenteric artery (SMA), the artery supplying most of     the intestine, both pre- and 45 minutes post feeding. The investigators will also use     echocardiogram to determine the presence or absence of PDA. Each set of measurements will be     done immediately before and after the transfusion, and again 24 and 48 hours after the     transfusion.      Specific Hypothesis: The investigators hypothesize that infants will have attenuated     postprandial blood flow velocities in immediate posttransfusion state when compared to the     pretransfusion values. The investigators further hypothesize that normal, pretransfusion     postprandial blood flow velocities will be achieved 48 hrs after the blood transfusion.   "
126589|NCT01628120|"     To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC     administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in     patients treated for anemia associated with chronic renal failure and on hemodialysis.   "
126590|NCT01628107|"     The purpose of the study is to determine the long-term safety in treatment-emergent adverse     events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of     target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal     failure and on hemodialysis.   "
126591|NCT01628094|"     This randomized, open-label, multicenter study will evaluate the safety , efficacy and     tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus     (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In     Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731,     RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further     treatment-naïve patients will receive a successful regimen from Part 1, or a reduced     intensity regimen, and patients who have previously experienced null response to     interferon-based treatment will be added to the study.   "
126592|NCT01628081|"     This is a double blind, parallel group, randomized study with 12 weeks of daily oral     administration of Dunaliella or placebo in psoriasis patients.   "
126593|NCT01628068|"     Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of     gastrointestinal bleeding. The investigators propose the percutaneous stop the oral     anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in     patients receiving anticoagulant therapy for atrial fibrillation without associated valvular     heart disease, to reduce significantly the risk of stroke while minimizing the risk of     bleeding in a group of patients with high risk for both events.      ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is     a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of     atrial appendage left versus standard treatment with oral anticoagulants in patients with     history of gastrointestinal bleeding and high embolic risk.   "
126627|NCT01627626|"     The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective     dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic     patients.   "
126594|NCT01628055|"     The purpose of the study is to evaluate the ability of IVIG to affect the rate of progression     of brain ischemia, as evidenced by neuroimaging.      The results of an ongoing epidemiological study indicate that patients with primary     immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that     is 5 times less than in the general population. Even more striking is the absence of stroke     in IVIG-treated PID patients over 65, while in the same general population age group the     stroke prevalence goes up to 8.1%. This suggests that the degree of stroke protection     correlates with the length of IVIG treatment, since older PID patients have been treated with     IVIG significantly longer than younger ones.   "
126595|NCT01628042|"     This study will investigate the impact of impaired renal function on the plasma     pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in     participants with overactive bladder and to guide recommendations on potential dosing     adjustments for individuals with varying degrees of renal impairment.   "
126596|NCT01628029|"     The goal of this clinical research study is to learn about the effects of different     combinations of melatonin, supportive counseling, light therapy, and methylphenidate/placebo     in patients with cancer having sleep problems. The safety of these treatment combinations     will also be studied.      Methylphenidate is designed to increase the activity of the central nervous system.      Melatonin is a hormone that is made by the brain and may help in letting your body know when     it is time to go to sleep and when it is time to wake up.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     symptom, disease or illness. It is designed to be compared with a study drug to learn if the     study drug has any real effect.      Light therapy is designed to help people sleep better.      Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression,     pain, and/or sleep disorders.      The use of the therapies to treat sleep disturbance in combination is experimental.   "
126597|NCT01628016|"     The purpose of this study is to test whether attention bias modification training is an     effective neurobehavioral therapy to improve depressive symptoms.That is whether attention     bias modification training is superior to placebo in reducing depressive symptoms over 1 year     after training.   "
126598|NCT01628003|"     It is hypothesized that the long-term results of rehabilitation and subsequent aging after     Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive,     emotional) reserves.      The purpose of this study are:        1. to determine whether such reserves exist.        2. to study their convergent and discriminant validity.        3. to study their characteristics.   "
126599|NCT01627990|"     The purpose of this study is to observe the tolerability, safety and efficacy of preventative     treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.   "
126600|NCT01627977|"     The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin     and brilliant blue to stain the internal limiting membrane as well as the epiretinal     membranes during the Vitrectomy surgery.   "
126601|NCT01627964|"     The study develops software for motion analysis and assessment of cardiac function for     cardiac images. Cardiac catheterization ventriculography of several randomly selected     patients were taken from our hospital's PACS system. The investigators remove the patient     information on the images, and use the image for motion analysis and assessment.   "
126602|NCT01627951|"     An effective vaccine against malaria is urgently needed to combat the scourge of this     disease. Before candidate vaccines can be tested in endemic countries, they are first tested     in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a     candidate vaccine should be tested against multiple strains of malaria, representative of the     disease's global distribution. To date, however, only one such strain (NF54) has been broadly     used in CHMI's.      The purpose of this study is to compare the course of infections with 2 novel malaria strains     to those with NF54 in human volunteers.   "
126603|NCT01627938|"     This study will primarily address the question whether the combination of Mitoxantrone     therapy with dexrazoxane can reduce cardiotoxic side effects in the treatment of Multiple     Sclerosis patients in comparison to Mitoxantrone monotherapy.   "
126604|NCT01627925|"     Upper airway obstruction (UAO) is a frequently occurring complication during induction of     general anesthesia. The American Society of Anesthesiologist (ASA) closed claim analysis of     anesthesia complications indicate that a difficult airway is one of the most challenging     scenarios continuously facing anesthesia providers.      The mechanism of UAO during anesthesia has not been well understood. Posterior displacement     of soft palate, tongue and epiglottis are believed to be the primary contributing factors.     Obesity is well known to be an essential characteristic which reflects propensity to UAO. The     mechanism of UAO during anesthesia shares many similarities with the upper airway obstruction     observed during obstructive sleep apnea (OSA). Nasal continuous positive airway pressure     (nCPAP) via nasal mask (NM) can maintain the airway patent with near 100% success in patients     with OSA. Obesity is a major risk factors for obstructive sleep apnea and obese patients have     a higher prevalence of UAO during anesthesia. Therefore, the investigators hypotheses that     nCPAP should eliminate airway obstruction in obese patients under anesthesia. The     investigators propose to test this hypothesis and determine the efficacy of nCPAP on     maintaining airway patency in obese patients who require general anesthesia.   "
126605|NCT01627912|"     The purpose of this study is to investigate whether red and white wine consumption has acute     effects on postprandial biochemical markers related to platelet aggregation, inflammation and     oxidative stress compared to water or 12.5% ethanol aqueous solution consumption.   "
126606|NCT01627899|"     Evaluation of the clinical benefits of One Touch VerioIQ system   "
126607|NCT01627886|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,     crossover, oral bioequivalence study.   "
126608|NCT01627873|"     The purpose of this study is to investigate the effects of two different analgesic methods     (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status     of patients.   "
126609|NCT01627860|"     The purpose of this study is to examine seizure control and tolerability of Topiramate after     either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.   "
126610|NCT01627847|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,     crossover, oral bioequivalence study.   "
126614|NCT01627795|"     Malignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial     surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from the     tunica vaginalis or pericardium. It has an extremely poor prognosis with a median survival of     4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients, regardless     of the therapeutic approach.      The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies     and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12     months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no     dose-limiting toxicities observed.   "
126615|NCT01627782|"     The purpose of this study is to explore the optimal dose frequency of ketamine in patients     with treatment-resistant depression (TRD).   "
126616|NCT01627769|"     It is well documented that following thermal burns injury the development of hypertrophic     scars and keloid (HSK) ranges between 40 to 90%. on the other hand It is well documented that     cryosurgery wounds generally heal with minimal tissue contraction, resulting in good cosmetic     results and with minimal complications.      The Aim of the study is To specify the burn and cryosurgery blister fluid for proteins,     cytokines and cells and To compare between the above data regarding possible proteins,     cytokines and cells, in regard to their possible effect on scarring and wound healing.      Also to Identify those components which are present only in the cryosurgery blister and which     might have an anti-scarring effect and to characterize them biochemically.   "
126617|NCT01627756|"     Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response. The     investigators examined whether continued mechanical ventilation during CPB alters systemic     immune activation.   "
126618|NCT01627743|"     This is a multi-center, prospective, non-interventional study that aims to evaluate in daily     clinical practice, the possible corelation between patIent perception of the ability to     perform morning activities and physician evaluation; patients with COPD, grade C and D.   "
126619|NCT01627730|"     This research work develops a diagnostic and feedback-providing system for self-learning by     volunteers who are asked to log in to a website to study the required subjects in three     weeks.      The system establishes students' learning weaknesses and offered guidelines for their     improvement until all such weaknesses are corrected.      Assessment is based on students' relative growth scores, and their record profiles.   "
126620|NCT01627717|"     Infection by both HIV and hepatitis C virus (HCV)is frequent due to similar transmission     modes. Near 20% of people living with HIV are also infected by HCV. People living with HIV     are treated by anti-HIV medications that may interact with numerous other medications,     including new medications against HCV.      Boceprevir is one of these new HCV medications and it is now considered as part of the     standard of care for people infected with HCV. Previous research has shown boceprevir may     influence the capacity of the liver to breakdown (metabolize) certain medications and when     these medications are used in combination with boceprevir, their blood concentrations may be     increased or decreased which could increase the risk of side effects or decrease efficacy.     Among the drugs having a potential for an interaction with boceprevir is maraviroc, an     anti-HIV medication. If concentrations of maraviroc increase, people may experience more side     effects. However, if concentrations of maraviroc decrease, people living with HIV may have a     lower suppression of the virus. This could increase the risk for the HIV virus to develop     resistance, that is that the treatment will no longer be effective. No studies have been     conducted to investigate the effects of boceprevir on blood concentrations of maraviroc. This     research project addresses this research question. This project, however, cannot be done with     people living with HIV since resistance may develop in these people if the concentrations of     maraviroc decrease. It is for this reason that the investigators wish to recruit healthy     people not infected with HIV nor HCV.      Eleven healthy volunteers will be included. They will receive maraviroc 150 mg (1 tablet)     every 12 hours from days 1 to 19 inclusively. On day 5, a total of ten blood samples will be     drawn during the following 12 hours (at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours after     maraviroc morning dose intake) to measure the blood concentrations of maraviroc. Boceprevir     800 mg (4 capsules) every 8 hours with food will be started on day 6 and continued until day     19 inclusively. On day 19, after the morning maraviroc and boceprevir dose, another ten blood     samples will be drawn over a 12 hour period. A phone follow-up will be done on day 26. Thus,     the total study duration for subjects is 26 days. The investigators will compare the blood     concentrations of maraviroc when given alone to the blood concentrations of maraviroc when     given with boceprevir.   "
126621|NCT01627704|"     Compare the response rate after 6 months of hormone treatment (or a major change in hormone     treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions     taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in     patients with all metastases taking up FES prior to treatment.   "
126622|NCT01627691|"     The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve     System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe     calcific aortic stenosis who are considered high risk for surgical valve replacement.   "
126623|NCT01627678|"     Background:      Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which     control the HIV infection and results in increases in CD4 cell counts and an undetectable     viral load, many patients suffer from increased morbidity. There is evidence that presence of     antibodies against the C5 region of gp120 strongly correlates with slower disease     progression, and that loss of antibody responses to this region are associated with     progression.      Investigational product:      Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the     C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a     non-neutralizing antibody against C5 region.      Study objectives:        1. To evaluate safety of the vaccination regimens        2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell          activation markers and other immune markers.   "
126624|NCT01627665|"     The study will address the impact of genetical variation of a protein involved in the     intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.   "
126625|NCT01627652|"     This scientific study aims at studying human adaptations to high altitude and the studies     will be conducted at the University of Zürich and during a 4 week high altitude expedition     to the Jungfraujoch research station at 3450 m altitude. The proposal is made up of several     independent biological research projects to be conducted in the same healthy volunteers     participating in the study. Thus, the subjects will be studied at sea level, and then during     4 weeks of acclimatization to high altitude, and for some experimental purposes all subjects     will also be studied one and two weeks after return to sea level.   "
126629|NCT01627600|"     The aim of the Atahualpa project is to evaluate the cardiovascular (CVH) status of the     inhabitants of a rural village of coastal Ecuador as well as to determine the prevalence and     retrospective incidence of stroke and ischemic heart disease. The protocol may be used as a     pilot for large-scale studies attempting to evaluate the CVH of rural or even urban centers     of Latin America, to implement cost-effective strategies directed to reduce the burden of     stroke and cardiovascular diseases in the population at large.   "
126636|NCT01627509|"     Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways     :        -  as Basal/bolus therapy (B/B) in four-five injections per day .        -  as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is          achieved, the more likely patient would suffer from hypoglycemic episodes. We propose          that the probability of hypoglycemia and its severity has no difference in two main          insulin therapy schemes mentioned above.      The objective of the study is to compare the incidence of hypoglycemia and its severity in     well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens,     through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style     Navigator).   "
126637|NCT01627496|"     The aim of this study is to determine the nutritional status, and factors affecting     malnutrition in older people staying in hospitals.      Objectives:        -  To recruit a sample of older people in hospital        -  To collect information on nutritional status, satisfaction with food-related life and          experience with access to food in hospital.        -  To assess the staffing attitudes to nutritional care of the older adult        -  To undertake an audit of therapeutic ('special') diets served in hospitals, with respect          to their nutritional adequacy and wastage        -  To investigate predictors and correlates of malnutrition within the hospital setting and          compare these relationships with those previously identified in care homes and the          community.        -  To make recommendations for practice to improve the nutritional status of hospitalised          older adults.   "
126638|NCT01627483|"     The aim of this study is to investigate if prescribing of fall-risk increasing and     fracture-preventing drugs can be improved in older hip fracture patients by assessments of     risks of falls and fractures and medication reviews performed by a physician and forwarded to     prescribing physicians.   "
126639|NCT01627470|"     The aim of the study is to evaluate the accuracy of continuous non-invasive AP monitoring     (CNAP) compared to simultaneous IBP measurement in intensive care patients undergoing a     transport in the ambulance car.      Since CNAP finger blood pressure is calibrated to NBP level, a systematic bias between IBP     and CNAP as described by a recent FDA meta analysis [ ] is expected. The most important     factor of CNAP system performance is its ability to accurately track blood pressure changes.     Thus, the purpose of this investigation is to show that the bias between CNAP and IBP falls     within the expected range and that blood pressure alterations are detected instantaneously.      The endpoints of the study are:        -  The agreement of systolic, diastolic and mean CNAP and IBP readings determined on a          beat-to-beat basis during:        -  Takeover of the patient on the intensive care unit,        -  Transport of the patient from the intensive care unit to the ambulance car        -  Transport of the patient in the ambulance car        -  The agreement of systolic, diastolic and mean CNAP and IBP blood pres-sure changes          determined on a beat-to-beat basis during:        -  Takeover of the patient on the intensive care unit,        -  Transport of the patient from the intensive care unit to the ambulance car        -  Transport of the patient in the ambulance car      The beat-to-beat readings of CNAP and IBP will be automatically recorded electronically on a     memory card in the transport monitor. CNAP data will additionally be recorded directly on the     CNAP Monitor with a memory stick. Safety will be assessed by clinical observations as well as     adverse events (AE) recording.   "
126651|NCT01627301|"     Patients with post-traumatic stress disorder (PTSD)and prehypertension (borderline high blood     pressure) are at higher risk for developing high blood pressure and heart disease. The     purpose of this study is to test whether PTSD patients have exaggerated increases in blood     pressure, heart rate, and adrenaline levels during different forms of stress, that might     predispose them to developing high blood pressure and heart disease. This study will also     evaluate whether regular sessions of slow breathing that is guided by a device (RESPeRATE)     improves blood pressure, heart rate, and adrenaline levels during stress in patients with     PTSD and prehypertension.   "
126652|NCT01627288|"     The purpose of this study is to determine the maximum tolerated dose of integrated boost     radiation therapy when given with concurrent chemotherapy (cisplatin).   "
126640|NCT01627457|"     In this Prestudy which will be followed by the multicentral GEx- main-trial, the feasibility     of a new cardiac rehabilitation device (GEx system) is proved with coronary heart disease     patients who participate in cardiac rehabilitation training exercise at the rehabilitation     clinic (phase II) and subsequently at home (phase III). The GEx system consists of a     easy-to-wear vest with integrated electrodes to measure electrocardiogram (ECG), respiration     and activity, furthermore of a PDA to collect and store the monitored data and a cradle to     charge the batteries. Several physiological parameters are extracted from thes measured vital     signs like heart rate, breathing rate, ECG and activity. In this pretrial first the GEx     sensor system is validated during guided exercise of the patients in the rehabilitation     clinic (phase II). Subsequently at home (phase III) the practicability of the vest and     sensors and possible technical problems in real- life use are proved. This means after     moderate training like walking, cycling or running at home for 3 weeks patients will report     the feasibility of usage. The ECG data and breathing- frequency data will be analyzed to see     if data are recorded and transmitted well in regard to technical problems.   "
126641|NCT01627444|"     Does ear acupuncture reduce anxiety in mother of very low birth weight infants?   "
126642|NCT01627431|"     The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and     its prevalence increase with age and with the simultaneous presence of cardiovascular risk     factors.      PAD patients are usually treated, as a first line treatment, with the exercise therapy,     combined with the pharmacological antiplatelet therapy.      In the case of first line therapy failure, PAD patients usually undergoing to invasive     revascularization procedures.      After a peripheral stent has been located, the major follow-up problem is the restenosis     rate.      Published studies describe how, in a large amount of patients, can be recognised an high     residual platelet activity. These data about PAD patients at the moment are lacking .      The authors would evaluate the incidence of PAD patients with an high residual platelet     activity.   "
126692|NCT01626768|"     The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study,     multi-center clinical investigation.      The purpose of this clinical investigation is to collect high quality medical images of the     Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the     study will allow for lead design and testing processes better tailored to the implanted     environment.   "
126643|NCT01627418|"     Aim      The purpose of this study is to evaluate whether fuel subsidies reduce exacerbations of COPD     among people aged over 55, and therefore whether providing such subsidies is a     cost-beneficial policy initiative.      The Warm Homes for Elder New Zealanders Study enrolled community-dwelling people aged over 55     with moderate or worse COPD. Prior to the study commencing the houses were insulated (if     feasible, & the house-owner agreed). Data were collected on the health and energy use of the     participants.      The households randomly assigned to the early intervention group had a subsidy to their     power account their first winter in the study. The subsidy was the intervention and was     designed to enable the participants, if they chose to do so, to keep their house warmer     during the winter.   "
126644|NCT01627392|"     The purpose of the study is to learn more about tobacco dependence and nicotine metabolism in     African-Americans and whites, by studying to see if how fast a person metabolizes nicotine     (how the body breaks down nicotine into inactive compounds) affects how dependent they are on     smoking cigarettes. The investigators believe that people with a faster rate of metabolism     may have more severe nicotine withdrawal symptoms and also may have a harder time trying to     quit smoking.   "
126645|NCT01627379|"     More than 50% of patients with esophageal cancer have locally advanced or metastatic disease     at presentation. The use of chemotherapy for this patient group is increasing with the     intention of local and distant tumor control, improving quality of life and prolongation of     survival.      Previous data suggested not only that EGFR antibody targeted therapy may be safely combined     with cisplatin and 5-FU but also may increase the efficacy of standard cisplatin / 5-FU     regime.      In the present study, patients with nonresectable, advanced or metastatic esophageal squamous     cell cancer (ESCC) will receive chemotherapy or chemotherapy plus panitumumab every 3 weeks     until disease progression occurs.      The primary objective is to demonstrate superiority of 5-FU, Cisplatin and Panitumumab over     5-FU and Cisplatin alone in terms of overall survival in esophageal cancer.   "
126646|NCT01627366|"     Improvements in early detection and successful treatment of breast cancer have lead to a     steady rise in the number of breast cancer (BC) survivors. With so many individuals living     for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the     implementation of treatment summaries and survivorship care plans (TSSPs) as a mechanism to     improve ongoing clinical and coordination of care, and to address the immediate     post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial     burden of a cancer diagnosis. The need for TSSPs has also been strongly advocated by the     American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have     been included in the recently introduced Comprehensive Cancer Improvement Act (H.R. 1844).     This will be one of the first randomized controlled trials to test the efficacy of TSSPs.      The investigators will recruit 500 low income, medically underserved women from two county     public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 10-24 months after     breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to     test the efficacy of TSSPs. The investigators will randomize these women into one of two     groups: 1) a control condition of usual medical care and 2) an experimental condition of the     control condition + a tailored TSSP + 1 face-to-face nurse counseling session, with all     cancer specialists and primary care physicians of record also receiving the TSSP and a cover     letter suggesting how they can be clinically utilized.      The investigators specific aims are to assess and compare between experimental and control     groups the following primary outcomes at one year post-intervention: 1) discussion and     implementation of recommended breast cancer survivorship care, including surveillance and the     evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with     survivorship communication and care, 3) pertinent aspects of health-related quality of life,     and further, to then 4) assess the cost-consequences of the experimental intervention. This     study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income,     underserved population of BC survivors known to be at high risk for poorer long-term     outcomes, including in mental health, quality of life, recurrence and mortality, and will     therefore allow us to demonstrate the greatest possible benefit of such an intervention.   "
126647|NCT01627353|"     The study is a blinded randomized clinical trial, comparing policies of high volume     preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no     wound infiltration and routine anesthesia) for post operative pain management after     hysterectomy. Morphine use and pain will be measured during index admission, and pain will     also be measured six weeks postoperatively. The study will be conducted at a single site,     Rockyview General Hospital.   "
126648|NCT01627340|"     This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine)     when administered as a primary vaccination course at 0, 1 and 6 months in adults with or     without type 2 diabetes mellitus.   "
126649|NCT01627327|"     The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone     Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide     inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who     have or are at risk for co-morbid cardiovascular disease   "
126653|NCT01627275|"     Allogeneic stem cell transplantation offers the hope of cure for a wide variety of     hematologic malignancies. Mature donor T-cells play a critical role in the success or failure     of this procedure and a subset of donor T-cells mediate graft-versus-host disease while other     subsets provide the foundation for immune recovery. The major challenge in allogeneic stem     cell transplantation is determining how to maximally exploit the beneficial effects mediated     by T-cells without causing GvHD. This challenge could be overcome by selectively depleting     the population of donor T-cells responsible for eliciting the GvHD response. The study     hypothesis is depletion of naïve T-cells from the donor lymphocyte inoculum will not cause     GVHD while providing T-cells to affect both anti-infection and anti-tumor responses.   "
126654|NCT01627262|"     The purpose of this study is to determine whether mesalamine is effective in the treatment of     uncomplicated diverticular disease by reducing the pain.   "
126669|NCT01627067|"     The goal of this clinical research study is to learn if exemestane and everolimus combined     with metformin can help to control breast cancer in patients who are obese or overweight and     post-menopausal with hormone-receptor-positive breast cancer that has spread to other parts     of the body.      Exemestane is designed to decrease the ability of estrogen to help cancer cells grow. This     could cause the cancer cells to die.      Metformin is commonly used to control blood sugar levels in patients with diabetes. It is     designed to lower insulin levels, which may slow or stop the growth of breast cancer cells.      Everolimus is designed to block cells from dividing. This may cause cancer cells to die.     Everolimus may also stop the growth of new blood vessels that help tumors grow.   "
126670|NCT01627054|"     The purpose of this study is to find out what effects a new drug AT7519M has on chronic     lymphocytic leukemia.   "
126714|NCT01626482|"     Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the     most investigated topics currently. However we do not know accurately the mechanisms that     produce it.      The aim of this study is to determine the influence of the Kinesio taping (KT) application in     the paravertebral muscle fatigue in a sample of healthy young subjects.   "
126655|NCT01627249|"     Although multiple studies have suggested that treatment with ranibizumab is safe and     efficacious and superior to focal/grid laser alone for patients with center-involved diabetic     macular edema (DME), there may be barriers in place to widespread adoption of ranibizumab use     given its high cost per dose and the need for multiple treatments over time. Prioritizing     resources from a public health policy perspective could be easier if more precise estimates     regarding the risks and benefits of other anti-vascular endothelial growth factor (anti-VEGF)     therapies were available, especially when the difference in costs could be billions of     dollars over just a few years. Thus, there is a clear rationale at this time to explore     potential anti-VEGF alternatives to ranibizumab that might prove to be as or more     efficacious, might deliver equally lasting or longer-lasting treatment effects, and cost     substantially less. Of the potentially available alternative anti-VEGF agents for this trial,     bevacizumab and aflibercept are the best candidates for a direct comparison study.     Bevacizumab shares the most similar molecular structure, costs far less, and is widely     available. Furthermore, there is already preliminary evidence to suggest that it may be     efficacious in the treatment of DME and it is already being widely used for this indication.     Although aflibercept has a similar cost per unit dose to ranibizumab, it has the potential to     decrease treatment burden and associated cost. If results from a comparative trial     demonstrate improved efficacy or suggest similar efficacy of bevacizumab or aflibercept over     ranibizumab, this information might give clinicians scientific rationale to substitute either     one of these drugs for ranibizumab in the treatment of DME, and might thereby have     substantial implications for public policy in terms of future estimates of health care     dollars and possibly number of treatments necessary for anti-VEGF treatment of diabetic     macular disease.      Because of its availability and lower cost, bevacizumab is already currently in widespread     clinical use for treatment of DME despite the lack of FDA approval for this indication. Thus,     a clinical trial that suggested whether bevacizumab could be used as a safe and efficacious     alternative to ranibizumab could substantially impact nationwide practice patterns for     treatment of DME by either validating the current use of bevacizumab or by demonstrating     improved outcomes with ranibizumab or aflibercept treatment for DME.      Study Objective The primary objective of the proposed research is to compare the efficacy and     safety of (1) intravitreal aflibercept, (2) intravitreal bevacizumab, and (3) intravitreal     ranibizumab when given to treat central-involved DME in eyes with visual acuity of 20/32 to     20/320.   "
126656|NCT01627236|"     The investigators will investigate the clinicopathological features of chronic hepatitis B     patients with severe exacerbation selected by uniform criteria, and treated with early     introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to     clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic     therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The     investigators also observe the immune index in the change before and after the treatment, in     order to searching for some prognostic index.   "
126657|NCT01627223|"     This is a prospective, observational, open-label, 2-arm, parallel, multi-center study.     Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such     as lamivudine and entecavir) is medically recommended will be screened for eligibility. To     target 74 evaluable subjects, approximately 82 patients should be recruited into this trial.     After enrollment, all eligible subjects will be randomly assigned to one of the antiviral     treatments below.        -  Cohort 1: Lamivudine 100 mg p.o. q.d.        -  Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, <          4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and          the first dose of observational drug should be administered on Day 1. The observational          period of individual subject will be 12 weeks; however, both treatments could be          continued after the end of study based on physician's clinical judgment.      The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180     days after initiation of antiviral treatment. All assessments should be conducted based on     routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be     performed in the central lab. For patients who are willing to provide the residual samples of     HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE will     be followed until resolution or the event is considered stable.   "
126658|NCT01627210|"     This is a prospective, non-randomized, observational study conducted in the United States.Up     to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term     utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will     be followed monthly over a period of one year.   "
126659|NCT01627197|"     Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients     cystectomized for locally advanced bladder cancer.   "
126660|NCT01627184|"     The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as     well as system performance during high levels of activity and home use by adult athletes with     insulin-requiring diabetes mellitus, over an extended period of time.   "
126661|NCT01627171|"     Colonoscopic examinations are performed routinely in hospitalized patients for a variety of     indications. However, numerous limitations exist in hospitalized patients preventing an     endoscopist from performing high quality examinations; possibly necessitating repeated     procedures leading to increased cost and re-exposure to their inherent risks. One such     prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown     to be a predictor of poor bowel preparation as these patients are older, less mobile and have     more co morbidities than the outpatient population. Currently, no standardized (or optimized)     bowel preparation type or regimen for administration exists for the hospital inpatient     population undergoing colonoscopy. Studies in the outpatient population have demonstrated     that timing and choice of cathartic medication effects the cleanliness of the bowel     preparation but there is no such clinical evidence for in-patients who receive whatever     cathartic agent is on hospital formulary. The purpose of the study is compare efficacy,     patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax)     to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of     dosages.   "
126662|NCT01627158|"     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.   "
140476|NCT01445951|"     Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of     TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination     with a basal insulin   "
126667|NCT01627093|"     The goal of this data review research study is to collect medical record information from     patients with head and neck cancer that have received or are scheduled to receive proton     therapy at MD Anderson. Researchers will study the medical record information to try and     improve therapy for future patients with head and neck cancer.   "
126668|NCT01627080|"     The goal of this clinical research study is to learn if the radiation that you will receive     for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.      When cardiac biomarkers are above normal levels, there may be heart damage. The relationship     between cardiac biomarkers and radiation therapy has not been well studied. Learning more     about this relationship may lead to better ways to check the heart during radiation therapy     and predict heart problems.   "
126671|NCT01627041|"     This randomized phase II trial studies how well decitabine works when given together with     daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia.     Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine,     work in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine     kill more cancer cells by making them more sensitive to the drugs. It is not yet known     whether low-dose decitabine is more effective than high-dose decitabine when giving together     with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.   "
126672|NCT01627028|"     To investigate the skeletal effect of Thai traditional massage by examining the changes in     biochemical markers of bone turnover.   "
126673|NCT01627015|"     In this study, the safety, acceptance and metabolic effects in infants receiving a novel low     glycaemic index follow-on formula will be investigated.      After 4 week intervention period, metabolic response after feeding is significantly different     between a follow-on formula containing low glycaemic carbohydrate and a conventional     follow-on formula containing higher glycaemic carbohydrates.   "
126674|NCT01627002|"     The purpose of this study is to examine the safety, tolerability, immunogenicity and the way     the body absorbs, distributes, breaks down and excretes various increasing single and     multiple subcutaneous doses of PA401 in healthy subjects.      This study will also look at the effect of PA401 on inflammation in the lungs following an     inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum     induction (a procedure performed to help to cough up sputum (phlegm)) after a single     subcutaneous dose of two dose levels.   "
126675|NCT01626989|"     Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining     if the new device will treat those participants no worse than when compared to its     predecessor device.   "
126676|NCT01626976|"     This is the first-in-human study for an oral investigational compound, PF-06282999, in order     to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose     levels.   "
126677|NCT01626963|"     Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal     resections, due to it's short-term benefits over conventional open surgery. In recent years,     several studies have demonstrated that - in suitable patients - single-port access surgery     (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It     remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.      In this study, the investigators aim to randomise patients who are deemed suitable for SPA     surgery to either SPA approach, or CL; in addition to clinical outcomes including length of     operating time, post-operative pain scores, complications, quality of life indicators and     cosmetic appearance, the investigators aim to compare the physiological response to trauma     through biochemical markers (including C-reactive protein, White Blood Cell count) and     cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to     intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The     patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up     for the duration of their hospitalisation as well as at their routine out-patient visits,     using questionnaires.   "
126678|NCT01626950|"     The main objective of this study is to estimate of the link (odds ratio) between the     precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at     diagnosis (2 groups: CAS: stages 1 or 2 the good prognosis versus the witnesses: stage 3 or     4 bad prognosis).   "
126689|NCT01626807|"     Just two generations ago, walking or bicycling to school was the norm for a substantial     number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13%     in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic, which     is at record high levels in the US and affects low-income and ethnic minority children the     most. This project will test the walking school bus (WSB) program, in which children walk     to and from school with adults, and its impact on low-income, ethnic minority children's     walking to school, physical activity, and risk for obesity. Ultimately, this line of research     has the potential to provide a low-cost, easy to disseminate program to reduce risk of     obesity and cancer for at-risk children.      The investigators Specific Aims among 3rd-5th grade children include:      SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a     cluster randomized controlled trial to assess the efficacy of a WSB program on children's     walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and     analyze data on individual-, school-, and macro-level influences on changes to children's     walking to school resulting from the WSB program      The Primary Hypotheses to be tested, in comparison to control children, include:      H1) The WSB program will increase children's walking to school over a school-year.      H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between     the WSB and changes to children's walking to school.      H1b) Walkability, safety, and acculturation will moderate changes to children's walking to     school.      H2) The WSB program will increase children's physical activity and decrease BMI z-scores over     a school-year.      H3) The WSB program will increase school-level pedestrian safety behaviors over a     school-year.   "
128109|NCT01608230|"     This study is being done to learn more about genetic mutations in cancer cells and to find     out how the development of new technologies can increase knowledge of these mutations and     possibly predict an individual's response to certain treatments.   "
126679|NCT01626937|"     Goal of the study: To show that prehospital NPPV use for COPD decompensation, as compared to     only standard medical treatment, might enable a decrease in intubation rate.      Primary end point: the rate of endotracheal intubation in the first three hours after     randomization.      Secondary en points: rate of endotracheal intubation after third hour, rate of prehospital     and ICU mortality, ICU days, effects on clinical parameters (respiratory rate, SpO2, heart     rate, arterial blood pressure, consciousness) and arterial blood gases (pH, PaCO2, PaO2), 30     days mortality, delays between first medical contact and in-hospital admission, relation     between initial pH level and endotracheal intubation.      Inclusion criteria: Adult patients (>18 years), with GCS≥10, known or suspected COPD and     presenting acute respiratory decompensation with respiratory acidosis.      Exclusion criteria: Cardiac or respiratory arrest, upper gastro intestinal tract haemorrhage,     shock, serious ventricular arrhythmia, severe sepsis, multiple organ failure, serious     cranial-facial trauma, upper airways obstruction, undrained pneumothorax,     uncooperative-agitated patients refusing the technique, respiratory distress with bradypnoea     < 12/min, pauses gasps repeated bradycardia, intractable vomiting, acute traumatic     tetraplegia, persistant hemodynamic instability with PAS<90mmHg, ensuitable environment.      Randomization: Assignment to NPPV group or standard therapy group will be performed at the     time of arrival of the SAMU team to the patient, by calling a physician located at the     calldispatch center who will connect to the web site of the clinical research unit from     Bordeaux university hospital.      Period of study: 25 months (24 months for patients inclusion and 1 month for follow-up).      Number of patients: 199 patients in each group i.e 398 patients (significance level of 5%,     power of 80%; 50% expected decrease of intubation rate, i.e. from 20 to 10%).      Main investigator: Dr Pierre-Arnaud Fort, MD, Pôle Urgences-SAMU47-Réanimation, Centre     Hospitalier Saint-Esprit - Agen.      Participating centers : 20 SAMU-SMUR corresponding to 19 departments in France.   "
126715|NCT01626469|"     The purpose of this study is to the determine the effect of salt intake and Captopril on the     ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.   "
126680|NCT01626924|"     In case of insufficient oxygen supply to the brain of a newborn child (perinatal asphyxia),     toxic compounds will be formed. These toxic compounds will damage the cells of the brain. 2     Iminobiotin (2 IB) is an investigational medicinal product that is related to vitamin B7.     From studies in animals it has been shown that 2-IB may prevent the formation of the toxic     compounds. Also it has been shown to be safe in in studies in juvenile animals and in     healthy, adult male volunteers. The doctors hope that this will prevent (part of) the     potential brain damage that may result from lack of oxygen to the brain.      This study is the first study in the target population: newborn with moderate to severe     oxygen shortage during birth. In this study the investigators evaluate short term efficacy,     safety and pharmacokinetics of 2-Iminobiotin. In the follow-up phase the investigators     evaluate the long term efficacy and safety.      The study hypothesis is that 2-Iminobiotin will help to decrease the brain damage after     oxygen shortage and is indeed safe. The brain damage will be measured both in the first week     and during the first two years of life. The study was designed as a study with two parts an     open label pilot part (6 patients) and a double-blind randomised part (60 patients). Due to     lack of recruitment it was decided in September2014 to stop recruitment after the open label     pilot part of the study (6 patients).   "
126681|NCT01626911|"     Our animal studies found that continuous regional arterial infusion (CRAI in the celiac     trunk) of low molecular weight heparin (LMWH) could alleviate inflammation, improve global     hemodynamics and restore organ function in a porcine model of severe acute pancreatitis     (SAP,unpublished).      In this study, the investigators aim to evaluate the effects of CRAI of LMWH in the treatment     of SAP patients. The investigators suppose CRAI could help improve the outcomes of these     patients.   "
126682|NCT01626898|"     Wake Forest University is partnering with Chatham Social Health Council (a community-based     organization) to conduct a randomized controlled trial to evaluate the efficacy of Hombres     Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups),     a Spanish-language HIV risk behavior intervention for Latino men who have sex with men (MSM)     in rural North Carolina.      Participants in the HOLA intervention, when compared to those in the comparison intervention,     will report: increased consistent use of condoms during sexual intercourse; increased use of     HIV and sexually transmitted disease (STD) counseling, testing, and treatment services;     greater knowledge concerning the impact of HIV on communities (including Latino and MSM)and     HIV risk behaviors and prevention strategies; more positive attitudes towards abstinence and     condom use; increased self-efficacy to use and assert the use of condoms with sex partners;     increased condom-use mastery scores; decreased barriers to risk reduction (e.g.     health-compromising aspects of machismo); and enhanced partner and provider communication and     sexual negotiation skills.   "
126683|NCT01626885|"     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy     of MP-214 in patients with receiving multiple drugs schizophrenia.   "
126684|NCT01626872|"     The objective of this study is to evaluate the long-term safety, tolerability, and efficacy     of MP-214 in patients with schizophrenia.   "
126685|NCT01626859|"     The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of     MP-214 in patients with schizophrenia.   "
126686|NCT01626846|"     The study will seek to determine whether there is a corresponding deficit in school     performance for teenagers with NF1. Secondly, the study seeks to explore the issue of     self-esteem in teenagers with NF1.   "
126687|NCT01626833|"     Anorexia nervosa may be responsible for a catch- down or even an interruption of growth,     delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of     normal nutrition usually leads to a resumption of growth and pubertal development. However,     despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients     have a significant short stature with reduced adult final height and a deficit of bone mass.     The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth     velocity in prepubertal children or children in early puberty with anorexia nervosa and     significant reduction of height velocity. This is a single-center, controlled, randomized and     double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against a     placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia     nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment     in children receiving placebo and continued hGH treatment in the treatment arm for 1 year, in     total 2 years of study for each child. This second period corresponds to an ethical     consideration giving secondarily access to treatment for patients in the placebo group.   "
126688|NCT01626820|"     This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition     (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and     safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.   "
128423|NCT01604109|"     The purpose of this study is to determine if adding daily application of CPP-ACP containing     paste for one year is superior to regular fluoride tooth brushing in preventing dental caries     in high caries risk Thai preschool children.   "
126690|NCT01626794|"     This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured     with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The     primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV)     antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks     after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response     rate at 6 weeks after vaccination 1.   "
126691|NCT01626781|"     The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as     prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with     gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®.      Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS.     Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS     have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as     for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a     significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected     for the standard arm, because it is used commonly, is accepted by patients, and seems to have     a positive influence on the severity of the HFS in the experience of many oncologists.   "
126693|NCT01626755|"     Phantom limb pain following amputation is a major problem. Current evidence how to best     prevent phantom limb pain is equivocal because previous trials have included small numbers of     patients, and tested heterogeneous patient collectives. There is some evidence that optimized     perioperative pain control is effective in preventing phantom limb pain, but the potential     added role of regional anesthesia has not been defined.      Objective:      The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point     prevalence of phantom limb pain 12 months after transtibial amputation for peripheral     vascular disease compared to optimized intravenous pain therapy.      Study design:      Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All     patients will receive standard optimized intravenous anesthesia and analgesia (opiate     patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group     will receive additional infusion of local anesthetic via a sciatic nerve catheter placed     under ultrasound guidance.      Main outcome of this study:      Point prevalence of chronic phantom limb pain after 12 months.   "
126694|NCT01626742|"     Evaluate effects of an oral nutritional supplement on healthcare outcomes in older     hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned     Readmissions and Survival in Hospitalized patients.   "
126695|NCT01626729|"     The U.S. food and beverage industry recently released a new front-of-package nutrition     labeling system called Facts Up Front that will be used on thousands of food products. The     purpose of this study was to test consumer understanding of the Facts Up Front nutrition     labeling system compared to the Multiple Traffic Light system (Traffic Light). Facts Up Front     displays grams/milligrams and % daily value information for various nutrients; Traffic Light     uses an interpretive color-coded scheme to alert consumers to low, medium or high levels of     certain nutrients. Participants in an Internet-based study were randomized to one of five     front-of-package label conditions: 1) No Label; 2) Traffic Light; 3) Traffic Light plus     information about protein and fiber (Traffic Light+); 4) Facts Up Front; or 5) Facts Up Front     plus information about nutrients to encourage (Facts Up Front+). Total percentage correct     quiz scores were generated reflecting participants' ability to compare two foods on nutrient     levels, based on their labels, and to estimate amounts of saturated fat, sugar, sodium, fiber     and protein in foods. 703 adult participants recruited through an online database in May 2011     participated in this Internet-based study and data were analyzed in June 2011. The     investigators hypothesized that the Traffic Light label groups would perform better than the     Facts Up Front groups on all outcomes.   "
126696|NCT01626716|"     Late-life depression is associated with physical limitations, greater functional impairment,     increased utilization and cost of health care, and suicide. Collaborative care, linking     primary and mental health specialty care, has been shown to be effective for the treatment of     late-life depression in primary care settings in Western countries. The primary aim of this     project is to implement a depression care management intervention, and examine its     effectiveness on the depressive symptoms of older patients in Korean primary care settings.     Based on chronic disease management theory and previous Collaborative care management studies     in western countries, we propose to test a Depression Care Management intervention,which     includes care manager to support a primary care physician of depression in their old     patients. Care manager'd role are monitoring the progress of treatment, supporting patient's     adherence, educating patients/ family and facilitate communication between providers. Also     psychiatrists provide consultation and supervision of care managers. Using a randomized     controlled design, we will examine whether the Depression care management is an effective     treatment for patients with late life depression in rural Korea. The primary outcome would be     the improvement of depressive symptoms of patients in primary care setting.   "
126697|NCT01626703|"     Depression affect between 5% and 10% of older adults seen in the primary care     setting.Late-life depression is often chronic or recurrent and is associated with substantial     suffering, functional impairment, and diminished health-related quality of life.Depressed,     older primary care patients are frequent users of general medical services and may have poor     adherence to medical treatments.They are also at increased risk of death from suicide and     medical illnesses. The aim of this study is to examine whether depression screening and     health care practitioner feedback are increased depression treatment rate.      Depression screening is provided 60 or more who visited community health care center with a     15-item Geriatric Depression Scale.GDS scores of 10 or more were classified depression     positive. Intervention group participants received twice remind calls from primary care     nurse.   "
126698|NCT01626690|"     The purpose of this study is to determine if placement of a forced-air warming device prior     to institution of regional anesthesia improves perioperative temperature control in patients     undergoing total hip arthroplasty.   "
126699|NCT01626677|"     This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®,     human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or     defects, compared with microfracture. Subjects who participated in and completed the Phase     III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.   "
126700|NCT01626664|"     The purpose of this study is to estimate the overall response rate of subjects with relapsed     or refractory Adult T-cell Leukemia-Lymphoma (ATL).   "
126701|NCT01626651|"     The purpose of this study is to assess the potential effects of ketoconazole on the     pharmacokinetics of ibrutinib in healthy participants.   "
126702|NCT01626638|"     The primary objective is to validate the diagnostic correlation between the intraoperative     microendoscopic images and the conventional histological analysis on biopsy and/or surgical     specimens on patients with epidermoid carcinoma.   "
126703|NCT01626625|"     The investigators hypothesized that mesenchymal stem cells can be isolated from fracture     site, iliac crest, and tibial crest, and can be expanded to be used in the management of     nonunion fracture.   "
126716|NCT01626456|"     This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS     9070) during long-term treatment of subjects with stable schizophrenia.   "
126783|NCT01625585|"     The goal of the present study is to investigate the clinical outcomes of patients with     gastrointestinal bleeding originating from the small intestine following diagnostic     investigation with single balloon enteroscopy. We hypothesize that single balloon enteroscopy     can arrive at a diagnosis and provide therapeutics in a majority of patients with     gastrointestinal bleeding originating in the small intestine.   "
126704|NCT01626612|"     Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit     patients. Early initiation of an appropriate empirical antimicrobial therapy is associated     with improved outcomes. In order to avoid an increase of selection pressure and the emergence     of multidrug resistant pathogens, guidelines recommend to streamline the antimicrobial     therapy after the identification of the pathogen responsible for infection. This strategy has     been evaluated in several observational studies. However, at the bedside, few randomized     clinical trials tested this strategy prospectively.      Method: the investigators conduct a randomized clinical trial comparing a strategy based on     de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative     strategy (continuation of the empirical antimicrobial therapy). The investigators first aim     was to show that a strategy based on de-escalation is not inferior to a conservative strategy     in terms of intensive care unit length of stay. Secondary aims are to compare the rate of     mortality rate, the emergence of multidrug resistant pathogens, and the feasibility of     de-escalation. The study is performed in nine intensive care units from four institutions,     and 120 patients are required to validate the investigators hypothesis. New technologies for     the rapid diagnosis of severe infections are investigated in an ancillary study.   "
126705|NCT01626599|"     This study is designed to collect data to support development of a novel product designed to     sense changes in heart rate or movement during periods of sleep in people with epilepsy. When     a potential seizure is detected, the system sends out an audio-visual notification.   "
126706|NCT01626586|"     In this research study the investigators want more about how being in a group about diabetes     helps your family versus individual treatment. The investigators are asking youth with     diabetes and their parents to be in the research, because the investigators want to see if     this diabetes group and/or individual therapy is helpful to your coping, adjustment, and     family communication about diabetes.   "
126707|NCT01626573|"     This is a study evaluating a 28-day course followed by a 56-day course of INCB039110 in     patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy     parameters of INCB039110.   "
126708|NCT01626560|"     Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and     IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative     treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both     groups according to levels of the cytokines evaluated.   "
126709|NCT01626547|"     The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients     receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple     myeloma and who are treated with Retacrit™.   "
126710|NCT01626534|"     Ticagrelor is a new P2Y12 ADP receptor antagonist. This drug demonstrated a faster onset of     action and a higher potency compared to clopidogrel standard regimen. Consistently these     properties were associated in the PLATO trial, and particularly in the percutaneous coronary     intervention (PCI) arm of the study, with a lower incidence of thrombotic complications at     one year follow-up but at a price of increased major bleedings (7,8). The major finding of     the trial was a significant reduction in one year mortality in patients treated with     ticagrelor. This reduction in mortality may not be related to the anti-platelet effect of the     drug since another potent anti-platelet agent which was recently commercialized a did not     exhibit any improvement in death compared to clopidogrel. Therefore there may be non anti     platelet directed properties, or pleiotropic effects, of ticagrelor that could be involved in     a reduction in mortality in acute coronary syndrome (ACS) patients. In fact together with its     anti platelet properties, ticagrelor, has been shown to inhibit the uptake of adenosine by     red cells, leading to an increase in adenosine plasma level and then activating the low     affinity adenosine receptor thus potentially affecting the vascular homeostasis including     endothelial cells. Therefore, it is hypothesis that the side effects and its benefit on     mortality may be related to its interaction with adenosine metabolism. In line with this     hypothesis, some adverse effects of ticagrelor (bradycardia and modulation of     bronchoconstriction) are compatible with the activation of low affinity A1 or A2A adenosine     receptors.      In addition the investigators have recently demonstrated that P2Y12 ADP blockade did impact     the endothelial compartment during PCI (9). In fact the investigators have observed that the     level of PR inhibition achieved by clopidogrel before PCI correlated with the extent of     endothelial damage during PCI. More potent anti platelet drugs such as ticagrelor may thus be     associated with reduced peri-procedural endothelial lesion which could further improve the     clinical prognosis of patients. The investigators have previously observed that endothelial     marker of lesion and regeneration could be measured in the blood post PCI (10).      Finally, in the response trial no patients in the ticagrelor arm had HTPR compared to 50% in     the clopidogrel arm (7). This finding is surprising since recent data suggest that some     patients still exhibit HTPR following the use of the very potent third generation     thienopyridine prasugrel. This may be related to the fact that in the response trial only     stable patients were included.      The investigators aimed to evaluate the anti-platelet efficacy and pleiotropic effects of     ticagrelor in acute coronary syndromes patients undergoing percutaneous coronary     intervention.   "
126711|NCT01626521|"     To access the clinical usefulness of F1+2 in the diagnosis of PE in patients with AECOPD who     require hospitalization. Specifically, to determine whether F1+2 may have an additional value     in the subgroup of patients with an abnormal D-dimer,to determine whether it may increase the     proportion of patients in whom PE can be safely ruled out and to determine the sensitivity,     specificity and NPV of F1+2 at various cut-off values.   "
126712|NCT01626508|"     The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated     breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution     of the total content and plasma profile of essential fatty acids (EFA) in a population of     premature infants.   "
126823|NCT01625065|"     In this study medication compliance regarding current drug use is investigated using     toxicological analyzes in two patient groups: patients from a pain management department and     pre-surgical control patients. The aim is to explore the incidence of concealed and feigned     substances and to determine the respective substance classes. Expecting that noncompliance is     higher in the pain patient group, the investigators want to identify clinical risk factors     for noncompliant drug report.   "
126713|NCT01626495|"     This is a study for children who have been previously treated for Leukemia/Lymphoma. In     particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B     cells (a type of white cell), which contain the cancer. This is a new approach for treatment     of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's     white blood cells (T cells) and modify them in order to target the cancer.      The subject's T cells will be modified in one or two different ways that will allow the cells     to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells the T     cells to go to the B cells (tumor cells) and turn on and potentially kill the B cells     (tumor cells). The modification is a genetic change to the T cells, or gene transfer, in     order to allow the modified T cells to recognize your tumor cells but not other normal cells     in the subject's body. These modified cells are called chimeric antigen receptor 19 (CART19)     T-cells.   "
127030|NCT01622335|"     The study is prospective and double blind. In the clinic, patients undergoing hysterectomy     that meet the criteria for inclusion into the study and agreed to participate in the study     will be randomized into two groups.   "
126717|NCT01626443|"     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of     reproductive age and is characterized by menstrual abnormalities, clinical or biochemical     hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often     suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of     developing several metabolic disorders. Inositol is a six-carbon polyol which has been     characterized as an insulin sensitizer: it exists as nine different isomers and among them     myo-inositol and D-chiroinositol are the most represented and studied in physiology and     physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans     administration has been reported to exert beneficial effects at metabolic, hormonal and     ovarian levels.      The aim of this randomized study is to evaluate the metabolic and ovaric effects of a     six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and     hyperinsulemia.   "
126718|NCT01626430|"     Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF)     on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at     risk for metabolic syndrome.      Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and     postprandial lipemia in individuals at risk for metabolic syndrome.   "
126719|NCT01626417|"     The objective of this clinical study is to examine the acute kinematics and kinetics of     utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing     sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings     (internal to the device); to compare these metrics to baseline performance without the Bionic     Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force     distribution) movement state in these patients.   "
126720|NCT01626404|"     Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients     are underserved. The purpose of this prospective, observational study is to obtain     multi-center data on the proportion of patients with CRT and/or ICD who are candidates for     advanced heart failure treatment and obtain insights into patient and physician decisions     regarding referral for advanced heart failure therapy.   "
126721|NCT01626391|"     The primary purpose of this study is to assess the safety and tolerability of TRx0237 when     taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or     rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.   "
126722|NCT01626378|"     The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the     treatment of patients with behavioral variant frontotemporal dementia (bvFTD).   "
126723|NCT01626365|"     The purpose of this study is to investigate the effect of double-lumen tube thermosoftening     before intubation to reduce postoperative hoarseness and sore throat.   "
126724|NCT01626352|"     This is a single-arm, Phase II study designed to enroll and treat up to 64 patients. All     patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6     cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion     bendamustine Days 1 and 2 of Cycles 1 through 6 and ofatumumab Days 1 and 8 during Cycle 1     only and on Day 1 of Cycles 2 through 6.   "
126725|NCT01626339|"     Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will     be recruited in this prospective self-controlled trial. Fundus photography will carried out     at baseline immediately before injection and at 3, 7 days and 30 days after the first     injection. Using image analysis software, measurements summarized as the central retinal     artery equivalent (CRAE) and central retinal vein equivalent (CRVE).      Null Hypothesis: There is no significant difference between arteriolar/venular diameter     before and after injection of intravitreal ranibizumab/bevacizumab in the treated and     untreated eye   "
126726|NCT01626326|"     This is an initial pilot study to determine whether people will use a research version of an     iPhone Stop Smoking app. The investigators primary measures will consist of rates of     recruitment (that is, number of people installing the app), use of the app, and completion of     follow-up surveys regarding self-reported smoking status. The investigators secondary measure     will be obtained quit rates and number of cigarettes smoked before and after using the app.      To enter the study, participants must download the app from iTunes at:      https://itunes.apple.com/us/app/san-francisco-stop-smoking/id522832206?mt=8   "
126727|NCT01626313|"     The study will examine the effectiveness of an eight session, manualized individual family     resiliency training (IFRT) for families with one OEF/OIF/OND veteran in promoting better     family communication relating to return to post military life.   "
126728|NCT01626300|"     The purpose of this study is to determine if the daily use of a certain amount and type of     milk component for 2 months provides a significant stimulation to the immune system and     specifically increases the chances of being protected against pneumonia after the     vaccination.   "
126729|NCT01626287|"     Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with     a woman's recovery and early motherhood.Mothers are offered a standard treatment after     childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However,     a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment     that may be more comfortable and effective for women is warm water soaked black tea bags.     Medicinal use of black tea bags has been based on their astringent (shrinking or     constricting) properties and have been used for various medical applications.      The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant     mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs;     n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing     recruitment, testing the protocol, and evaluating a proposed primary outcome objective of     analgesic use during hospitalization as an indicator of pain. The investigators expect this     pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the     efficacy of black tea bags to reduce perineal pain in this patient population.   "
126784|NCT01625572|"     The purpose of this study is to compare the quality of a transversus abdominis plane blockade     with an intravenous pain therapy with opioids. Due to the relatively low side effect profile     and comparably few contraindications, this method offers a good option, to be a standard     procedure or better alternative in the treatment of pain in surgery of the prostate.   "
126730|NCT01626274|"     The purpose of this study is to evaluate the feasibility of non-intrusive 24 hours     non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a     photoplethysmographic device for reflective mode measurements of the optical damping upper     skin layers inside of the ear canal at two different wave lengths. It consists of the in-ear     sensor, the electronics and a PC. Vital signs parameter like heart rate, heart rate     variability, breathing and arterial blood oxygenation are monitored in patients with sleep     apnoea and compared to measurements of standard polysomnography of these patients during one     night in the sleep laboratory.   "
126731|NCT01626261|"     The number of active electrical cardiac implants such as internal cardioverter defibrillators     (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the     last two decades. This has been paralleled by an increase in the number of sources of     electromagnetic fields in daily life and occupational circumstances.      To date it remains unclear whether patients are at risk of device failure when being     subjected to these fields. There are currently no general guidelines available to help     clinicians informing their patients about safety levels and behavior around these     electromagnetic fields.      This study aims to identify the thresholds of safe use of these devices and potential     failures under worst-case conditions in 50/60 Hz fields (i.e.      power line frequency). Device implanted patients will be exposed to electric, magnetic and     combined fields of different intensity at various device programming (e.g. nominal and     maximum sensitivity). The results will show whether patients are safe in public or     occupational environments, which medical relevant disturbances can occur and if a correlation     exists between disturbances and device type or patients physique.   "
126732|NCT01626248|"     The purpose of the study is to research the association between receiving Tysabri®     (natalizumab), interferon beta-1a, glatiramer acetate or not having any treatment for your MS     and how it may or may not impact certain white blood cells and other immunological markers.     This information may be useful in identifying risk factors in developing progressive     multifocal leukoencephalopathy (PML). It does appear that the risk increases with the total     number of natalizumab infusions. Patients who have not yet started a disease modifying     therapy or who have been on one other than natalizumab are needed as controls to see how     these biomarkers change.      Patients at various stages of natalizumab treatment as well as natalizumab naïve are needed     to allow for analysis of the change in potential markers over time.   "
126733|NCT01626235|"     Study aims to assess patient-recorded outcomes of pain control medications prescribed in the     ER after visits for specific painful injuries/illnesses.   "
126734|NCT01626222|"     The present multi-center, open-label, single-arm study aims to evaluate the efficacy and     safety, quality of life and health resources utilization in postmenopausal women with hormone     receptor positive breast cancer progressing following prior therapy with non-steroidal     aromatase inhibitors (NSAI) treated with the combination of Everolimus and Exemestane.   "
126735|NCT01626209|"     Dose escalation study with a dose expansion phase, to evaluate safety, tolerability,     pharmacokinetics and preliminary efficacy of two dose levels of BKM120 when administered     orally.   "
126736|NCT01626196|"     Several factors are important in achieving a successful colonoscopy, including patient     acceptability of the bowel cleansing procedure and the overall quality of cleansing.      This observational study has been designed to explore the main determinants of acceptability     of the bowel cleansing procedure to the patient in an Italian real life setting. In     addition, the study is to examine the determinants of quality of bowel cleansing and describe     aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma     detection rate).   "
126737|NCT01626183|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors identify and learn more about biomarkers related to cancer      PURPOSE: This laboratory study is looking into RNA in samples from younger patients with     T-cell (T) acute lymphoblastic leukemia (ALL).   "
126738|NCT01626170|"     This laboratory study is looking into mechanisms of radiation therapy resistance in samples     from younger patients with rhabdomyosarcoma. Studying samples of tissue from patients with     cancer in the laboratory may help doctors learn more about changes that occur in DNA and     identify biomarkers related to cancer. It may also help doctors find better ways to treat     cancer   "
126747|NCT01626053|"     It is hypothesized for this study that the coupling of the Millon Behavioral Medicine     Diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and     ongoing support can produce improved outcomes with diabetics who have previously been     unsuccessful with the traditional care. This study examined the relationship between     patients' HbA1c levels and patients' involvement in the ASMART program, a multifaceted     program involving psychological intervention. The study was conducted through the Kosciusko     Health Department and funded by K21 Health Foundation.   "
126824|NCT01625052|"     The investigators group has performed a number of studies on novel airway devices, including     an observational study on the performance of a new supraglottic airway named Baska mask. In     this new study the investigators wish to determine which criteria best predict the correct     size of the Baska mask to be used in male patients   "
126825|NCT01625039|"     The introduction of a wellness programme for workers employed in a clothing factory will     improve quality of life, pain, attendance at work and levels of physical activity.   "
126748|NCT01626040|"     The purpose of this study is to examine the effects of current standard of care Polyethylene     Gylcol powder (PEG-P)colonoscopy preparation on a patient's serum electrolytes, tolerance of     the prep, and how well the bowel is cleansed. The primary aim is to determine the proportion     of patients with clinically significant serum electrolyte abnormalities at the time of     colonoscopy and how well the prep is tolerated. Secondary objectives include: 1) how well the     bowel is cleansed with this preparation, and 2) to determine the most effective way to     communicate instructions about the bowel preparation with the child and family.   "
126749|NCT01626027|"     The aims of this prospective, observational study are to assess the current use of depression     care in Coronary Heart Disease (CHD) patients, and to provide estimates for the resources     needed to implement guideline-oriented depression health care acceptable to CHD patients with     comorbid depression.   "
127838|NCT01611766|"     The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and     validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian     cancer.   "
126739|NCT01626157|"     Inflammation is present in the Cystic fibrosis (CF) airway from the time of infancy, and     worsens with the onset of chronic infection. Therapies with proven benefit are associated     with decreased airway inflammation. Thus, sensitive and reproducible biomarkers of airway     inflammation have long been sought as a necessary component to improved clinical care and to     facilitate therapeutic trials for CF. FEV1, the standard outcome measure in CF, is recognized     as an insensitive outcome measure. the investigators have identified a panel of 10 genes     which sensitively predict resolution of pulmonary inflammation, in response to therapy of an     acute pulmonary exacerbation. With the goal of yielding a technically simple but unique CF     biomarker assay, the investigators have tested whether proteins signified by these genes show     large changes in expression following treatment of acute pulmonary exacerbations. Protein     quantifications are among the most common measurements performed in clinical laboratories     around the world. Based on preliminary findings that changes in white blood cell proteins     mirror changes seen in the genes, the investigators propose to identify top candidate     proteins, from the investigators gene panel, which change in response to exacerbation     therapy. Once identified, these proteins will be quantified directly with a new blood test     which is inexpensive and simple to perform. The investigators propose to validate this blood     test in a single site trial. If successful, this proposal will yield a biomarker assay that     will be available to validate in a multi-site trial and provide unique insights into     mechanisms that regulate white blood cell activation and recruitment in CF lung disease.   "
126740|NCT01626144|"     It is the investigators hypothesis that exemestane (EXE) metabolism is an important source of     the inter-individual variation in EXE metabolic profiles and that polymorphisms in     EXE-metabolizing enzymes may potentially play a role in affecting EXE therapeutic efficacy     and toxicity. The goals of this clinical study are to (1) establish EXE metabolism profile     kinetics, and (2) determine whether correlations exist in vivo between metabolizing enzyme     genotype and urinary EXE metabolite profiles in women being treated with EXE. Together, these     studies will allow us to fully characterize functionally-relevant polymorphisms in the     EXE-metabolizing enzyme pathway that are potentially important in EXE clinical efficacy.   "
126741|NCT01626131|"     The primary objective of this pilot intervention study is to examine the efficacy of exercise     for reducing the symptoms of posttraumatic stress disorder (PTSD) and other psychiatric and     somatic symptoms. The sample will be composed of veterans aged 18-65 with combat-related PTSD     (N = 40). Participants will be randomly assigned to one of two groups. Participants in the     exercise training group (n = 20) will receive three 60-75 minute sessions per week of     combination aerobic and resistance training for eight weeks. In the control stretching group,     participants (n = 20) will receive training in whole-body flexibility three times per week     for eight weeks. Secondary objectives include 1) determining feasibility of the intervention     (as measured by the percentage of prescribed days of exercise completed by each participant,     and percentage of time exercising completed at the prescribed intensity and duration); 2)     determining the influence of exercise training on aerobic fitness and strength in the sample;     and 3) determining whether psychiatric/somatic symptom improvements are associated with     improvements in fitness and strength. Finally, exploratory objectives will include examining     whether exercise training can improve early signs of heart disease, and whether certain     biomarkers (using MRI and fMRI data and inflammatory markers) are associated with treatment     response.   "
126742|NCT01626118|"     The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and     effective for the treatment of postoperative bunionectomy pain.   "
126743|NCT01626105|"     This study is designed to accurately identify the pharmacogenetic determinants of risk of     Factor VIII (FVIII) inhibitor development by focusing on only a select group of Hemophilia A     (HA) patients who have: (i) received a recombinant FVIII therapeutic product containing the     same primary amino acid sequence since their original diagnosis; (ii) verifiable FVIII     infusion histories; and (iii) been tested regularly for FVIII inhibitor development.   "
126744|NCT01626092|"     This study is designed to test the ability to achieve donor hematopoietic engraftment while     maintaining low rates of transplant-related mortality (TRM) in patients with high-risk     lysosomal and peroxisomal disorders using a novel conditioning regimen for hematopoietic cell     transplantation (HCT). After a reduced-intensity conditioning regimen using     volumetric-modulated arc therapy (VMAT)-delivered low-dose total body irradiation (TBI) with     highly conformal marrow boosting, patients will be transplanted using either a related or     unrelated allograft. The cell source may be marrow, peripheral blood or cord blood based on     donor availability.   "
126745|NCT01626079|"     The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy     for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm     the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe     or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are     treated per standard of care and who have been determined by the site's local heart team as     not appropriate for mitral valve surgery. This randomized controlled trial will provide the     opportunity to strengthen or add labeling claims regarding safety and clinical benefits of     the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe     functional mitral regurgitation.      Approximately 610 subjects will be randomized at up to 100 investigational sites with     approximately 305 subjects targeted to receive the study device.      As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary     exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise     responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group)     compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study     subjects will contribute to the analyses of the COAPT primary and secondary endpoints)      As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT     enrollment is complete under the same investigational device exemption (IDE(G120024)). The     objective of this study is to evaluate the MitraClip® NT System for the treatment of     clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure     subjects who are treated per standard of care and who have been determined by the site's     local heart team as not appropriate for mitral valve surgery. The anticipated study Primary     Completion date is July 2020 and the Study Completion Date is July 2024.   "
126746|NCT01626066|"     Real-time detection of cancer cells during surgical removal of a tumor is important.     Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology     when the margins (edges of the tissue) are examined to see if cancer cells are present. This     may take a few to several days. Patients tissue with positive (cancer cells present) margins     may require additional therapies including surgery. The purpose of this study is to determine     a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that     will show in the tumor area during surgery and may help facilitate visualization of tumor for     its removal.   "
127075|NCT01621750|"     To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's     formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation     (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fasting conditions and     to assess the bioequivalence.   "
126750|NCT01626014|"     Ovarian cancer accounts for more deaths than any other gynecologic malignancy. The majority     of patients are diagnosed with Stage III-IV disease. Nearly 80% of these patients will recur     resulting in 5-year survival rates of 14-32%. Although enrollment is increasing in hospice,     hospice programs have been challenged to reach eligible patients. Several factors limit the     number of people who enroll in hospice and the length of their hospice stay. Prognostication     challenges and the increasing availability of cancer therapies for people with cancer set the     stage for a mismatch between certification of a 6 month prognosis and contemporary medical     care. Additionally patients often are not aware of hospice and the services they can provide.   "
126751|NCT01626001|"     The goal of this clinical research study is to learn about ways to possibly reduce scanning     errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in     patients with esophageal or lung cancer.   "
126752|NCT01625988|"     To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in     migraineurs with or without aura during 3 months of treatment.   "
126753|NCT01625975|"     Understanding bone growth and achieving bone deformity corrections re-mains one of the oldest     challenges in paediatric orthopaedics.      The purpose of this study is to investigate the clinical and biomechanical effects of     implants for growth modulation in pediatric patients undergoing correction of leg length or     deformities of the knee.      The primary aim of the study is to assess outcome after growth modulation using the Eight     plate (Orthofix) at the time of implant removal with regard to any Adverse Events (AE)     related to the growth plates or implants under investigation. The secondary aims are to     assess if the planned correction was achieved and if the achieved correction was maintained     after implant removal. Furthermore, secondary aims include investigation of the number and     type of revision surgeries, the proportions of any other local AE as well as any influencing     factors for growth modulation.   "
126754|NCT01625962|"     This is a prospective, longitudinal cohort study to evaluate the associations between indices     of brain structure and function (measured at baseline, as soon as possible after injury) and     course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members     who have sustained mild traumatic brain injury (classified as either impact-induced mTBI or     blast-induced mTBI; n = 100 completers) or an extracranial injury (ECI) with no evidence of     traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment     battery at baseline and 6 months later that includes (1) structural magnetic resonance     imaging(MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2)     event-related brain potentials (ERPs) derived from brain electrical activity; (3)     neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain     structure and function derived from these assessments are hypothesized to demonstrate a     significant relationship with course of PTSD symptoms, which will be measured at baseline, 3     months, and 6 months.   "
126755|NCT01625949|"     Background: When an acute myocardial infarction occurs, the artery supplying the infarct zone     should be opened within twenty four hours of onset of infarction. This has clearly been shown     to be beneficial.      If the patient presents later than 24 hours of onset, at that stage a large part of the     damage to the heart is irreversible. Intervening at this stage (beyond 24 hours is     controversial). Some trials suggest that opening the artery even at this stage positively     modifies the remodeling process while other trials suggest that such a benefit is not seen.      Hypothesis: Opening an infarct related artery after 24 hours (until 6 months) and combining     it with intracoronary stem cell therapy may provide incremental benefit.It is possible that     the lack of benefit seen with late revascularization (>24 hrs) after MI may be offset by     giving intracoronary stem cells after opening the artery.   "
126756|NCT01625936|"     This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in     combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of     this study is to determine the initial safety and effectiveness of this agent in combination     with Bevacizumab. The investigators are also trying to determine the best dose level of     CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this     study at the University of Pennsylvania.   "
126757|NCT01625923|"     Gastroparesis is a disorder characterized by impaired gastric emptying in the absence of     obstruction in the proximal GI tract. It is a common condition affecting up to 5 million     persons in the United States alone. Despite this, metoclopramide is currently the only FDA     approved medication for the treatment of gastroparesis. However, the evidence supporting     metoclopramide in gastroparesis is fairly weak and was recently issued a black box warning     because of potential irreversible side effects. There is clearly an urgent need for newer     therapeutic options with better efficacy and tolerability. Olanzapine is a second generation     anti-psychotic that is currently FDA approved for the treatment of schizophrenia and bipolar     disorder. Because of actions at several receptors throughout the body, including dopamine and     serotonin receptors, Olanzapine may provide anti-nausea and pro-motility effects in the     stomach. Long-term use of olanzapine may also increase plasma levels of ghrelin. Ghrelin is a     hormone produced by the gut that stimulates appetite and has also been shown to have     beneficial effects on gastroparesis. The investigators hypothesize that olanzapine will be     effective and safe in controlling symptoms as well as stimulate appetite and weight gain in     gastroparesis. The investigators also hypothesize that olanzapine will stimulate gastric     motility. Finally, the investigators hypothesize that olanzapine will modulate the secretion     of ghrelin in gastroparesis. This pilot study may provide further information on the efficacy     and safety of olanzapine in gastroparesis which could be utilized in a larger randomized,     prospective study in the future.   "
126758|NCT01625910|"     Childhood obesity is a major public health problem in the U.S. Currently approximately one in     three children is considered overweight or obese. Most overweight children grow to become     overweight adults. It is unclear how effective pediatricians and other primary care     physicians can be in assisting overweight children to normalize their body weight. Expert     guidelines have been established, but are currently untested.      This study will randomize overweight and obese children between the ages of 4 and 8 years old     to either the recommended treatment guidelines or a control (non-intervention) group.      The purpose of this study is to evaluate the ability (a) to recruit overweight children     between the ages of 4 and 8 years old (b) to remeasure the children three months after     enrollment and (c) to reduce childhood obesity via implementation of the recommended     treatment guidelines.   "
127839|NCT01611753|"     The purpose of this study was to evaluate the immediate effects of red blood cells     transfusion on central venous oxygen saturation and lactate levels in septic shock patients     randomized to two different hemoglobin levels.      The influence of red blood cell (RBC) transfusion on the adequacy of oxygen delivery (DO2)     and supply (VO2) could be assessed by systemic oxygen variables such as central venous oxygen     saturation (ScvO2) and lactate levels. Although it is not clear that alterations in these     parameters actually represent an improvement in the DO2/VO2 ratio, they might represent a     better transfusion trigger than the absolute hemoglobin value.      Patients admitted with a diagnosis of septic shock and hemoglobin levels lower than 9.0 g/dL     , less than 48 hours of shock diagnosis, were included, a central venous catheter in the     superior vena cava and signed informed consent. The investigators randomized all patients     into two groups. Patients in the liberal group received transfusions immediately, as the     objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group,     transfusion was withheld until their hemoglobin levels fell below 7.0 g/dL.      Each time a patient received a transfusion, the investigators collected a set of laboratory     tests, including hemoglobin levels, ScvO2 and lactate, at two time points, immediately before     transfusion and one hour after its ending.      The sample size was calculated by considering that in 80% of the transfusions in patients in     the restrictive group ScvO2 would improve compared to only 45% of those in the liberal group,     with an alpha error of 0.05 and 80% power. Improvement was defined as an increase of 5% over     the pre-transfusion ScvO2. Twenty-eight transfusions in each group would be necessary, but to     correct for potential non-parametric distribution of the main variables, the number was     adjusted to 35 transfusions in each group.      Trends in ScvO2 and lactate were categorized as worsening or improving. The investigators     defined improvement when ScvO2 reached 70% in patients with baseline levels below this     threshold or when there was an absolute increase of at least 5% after transfusion. Any     increase in patients with previous ScvO2 ≥ 70% was considered to be no change. Worsening     was defined as a reduction of 5% in the previous levels or a decline to less than 70% in     patients with pre-transfusion levels in the range of 70 to 75%. The investigators also     carried out a ROC curve analysis to assess the accuracy of the pre-transfusion hemoglobin     levels, pre-transfusion lactate and pre-transfusion ScvO2 in predicting the patients whose     ScvO2 would increase more than 5% with transfusion. For this analysis, the investigators used     a different approach because it would also be necessary to analyze patients with a lower     chance of response to assess the prediction of response. Thus, this analysis included all     patients with ScvO2 below 75%, rather than only those below 70%. As before, the investigators     defined improvement as any increase ≥ 5%. The investigators did not consider patients with     levels above 75% in this analysis, as the physiological interpretation of this situation is     challenging. The investigators considered as altered any lactate levels above 1.5 times the     reference level, and a change ≥ 10% was defined as improvement or worsening. In patients with     baseline normal levels, the status was recorded as worsening if a 10% increase was detected.     Afterwards, the investigators tested the association between these categorized variables and     the baseline levels of hemoglobin. The impact on perfusion was also assessed by the     determination of Δlactate (lactate post-transfusion x 100/lactate pre-transfusion) and ΔScvO2     (ScvO2 post-transfusion x 100/ScvO2 pre-transfusion), and their correlation with the baseline     hemoglobin levels was analyzed using the Spearman correlation test.      In all tests, the results were considered significant if the p level was lower than 0.05.   "
126762|NCT01625858|"     The supraglottic airway device LMA Supreme has recently been introduced for pediatric     patients. The investigators will prospectively evaluate success rate and airway leak pressure     in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that the LMA     Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak pressures will     be compared to results from other pediatric supraglottic airway devices previously studied by     the investigators group. Secondary Hypothesis: The primary success rate of the LMA-S is     higher than 90%; therefore, performance is similar to the performance of the Ambu Aura Once™     and of the i-gel™. Study design: Prospective controlled observational cohort study.      In a second step, we will include more pediatric supraglottic airway devices. Each new arm     will be handled exactly the same, assuming the same hypothesis being justified.   "
126763|NCT01625845|"     The objective of this clinical trial is to evaluate whether an anti-inflammatory medication,     pentoxifylline, reduces depressive symptoms and improves artery function. Participants in     this trial will be older primary care patients (60 years and up) who are depressed but do not     have a history of cardiovascular disease. Half of these patients will receive pentoxifylline,     and half will receive placebo. In addition, participants in both arms will receive an     evidence-based psychological treatment called Beating the Blues®, which is a computerized,     cognitive behavioral treatment program for depression. The investigators will use     questionnaires to assess change in depressive symptoms and an ultrasound test to measure     change in artery function from pre- to post-treatment. It is hypothesized that patients who     receive pentoxifylline will show greater improvements in both depression and artery function     than patients who receive placebo.   "
126764|NCT01625832|"     Coronary artery disease (CAD) is the leading cause of morbidity and mortality in     industrialized countries despite advances in medical, interventional, and surgical     revascularization therapies. In both, acute myocardial infarction (AMI) and chronic stable     disease, standard therapeutic approaches may fail to restore tissue perfusion. Indeed, a     substantial number of chronic CAD patients may not be amenable to standard revascularization     therapies or percutaneous coronary intervention (PCI) may fail to restore coronary artery     patency following an acute vessel occlusion (no-reflow phenomenon, microvascular     obstruction). As a consequence, the long pursued strategy of augmenting myocardial perfusion     by diverting blood from the coronary venous system to an ischemic region (venous     retroperfusion) has again gained attention during recent years. Occlusion of the coronary     sinus (CSO) was introduced to provide retroperfusion by transient augmentation of coronary     venous pressure. Different devices using CSO have been invented and evaluated in animal     models and small clinical trials, e.g. intermittent CSO (ICSO) and pressure-controlled     intermittent CSO (PICSO) which seem to be effective for myocardial salvage. However, they are     not yet employed in clinical routine, and importantly, the exact underlying mechanisms by     which retroperfusion due to CSO may reduce myocardial ischemia are not yet understood.      As natural bypasses, coronary collaterals are anastomoses without an intervening capillary     bed between portions of the same coronary artery or between different coronary arteries that     represent an alternative source of blood supply to a myocardial area jeopardized by ischemia.     Collaterals of the heart can be assessed quantitatively by coronary pressure measurements,     which have become the gold standard (collateral flow index, CFI=[Poccl-CVP]/[Pao-CVP]).     Theoretically, augmentation of coronary sinus pressure by CSO with an increase of venous     backflow reaches the upstream collateral circulation, which in turn could lead to improved     collateral flow from non-ischemic area(s) to an occluded, ischemic myocardial region by     upstream flow diversion. On the other hand, when considering the formula to calculate     pressure-derived CFI, it seems that augmentation of coronary back pressure would rather     impair collateral flow (since central venous pressure is coronary sinus pressure). However,     the regional effect of a global increase in coronary sinus pressure is unlikely to be as     uniform as the above formula implies, i.e., the response is more pronounced in some than in     other vascular territories. In experimental studies using dogs (with abundant collaterals),     elevation of coronary sinus pressure caused an augmentation of regional myocardial blood flow     in the collateralized area. In contrast, when ICSO was performed in pigs (which possess no     preformed collaterals), it increased the pressure distal of an occluded LAD but did not     improve blood flow or left ventricular function.      In conclusion, experimental studies and pathophysiologic considerations suggest a necessary     role of the collateral circulation for the beneficial effects of coronary sinus occlusion     (CSO) observed in animals and humans; however, no clinical data are available so far on the     effect of CSO on myocardial ischemia in the presence of varying collateral flow.      Study hypotheses        1. CSO decreases intra-coronary ECG ST-segment elevation during a 2-minute coronary          occlusion.        2. The decrease in occlusive intra-coronary ECG ST elevation during CSO is directly          proportional to CFI.        3. Coronary sinus oxygen saturation during coronary occlusion with CSO is directly          proportional to CFI.   "
126765|NCT01625819|"     The objective of this research is to compare Tai Chi versus Resistance Exercise, Health     Education and usual care for changes in cardiac functional capacity measured for ability of     the heart to pump by measuring ejection fraction (EF), end systolic and diastolic volumes in     heart failure (HF) patients. Also measured will be changes in physical function measured by     walking speed and distance in the 6-min walk task, work performed during a bicycle task, and     changes in daily physical activity. The investigators will compare groups for altered     well-being including: depression, sleep disturbances, fatigue, mindfulness, spirituality and     quality of life. In addition the investigators will compare groups for altered vascular and     pro-inflammatory markers, catecholamines, and autonomic function at rest and in response to     the bicycle task. Also, the investigators will assess cardiac related hospitalization and     death over a 12 month period by examining medical records.   "
126766|NCT01625806|"     This single-center, open-label, parallel group study will evaluate the effects of multiple     doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male     volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects     assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours)     from Day 1 to Day 17.   "
126767|NCT01625793|"     The current study has been designed to identify behavioral and physiological mechanisms     through which positive social connectivity (PCS) and negative social processes (NSP) interact     with psychosocial stress to promote resilience in the context of illness. The investigators     model inflammation (a central element of all disease states) through the use of treatment     with interferon (IFN)-alpha, which provides a standardized regimen of chronic cytokine     exposure known to produce profound behavioral disturbances, including depression, fatigue and     sickness, in a high percentage of individuals. To objectively assess social processes, the     current project will employ the Electronically Activated Recorder (EAR), which periodically     and unobtrusively records snippets of ambient sounds in people's momentary environments. To     objectively assess behavioral and physiological responses to psychosocial stress the current     project will employ the Trier Social Stress Test (TSST), a standardized laboratory stressor     known to reliably activate behavioral, neuroendocrine and inflammatory responses. These novel     methodologies and model systems will be employed to test the hypotheses that (a) pre-existing     affiliative and prosocial behavior will promote resilience in the context of chronic     inflammation and that (b) —conversely—chronic inflammation will reduce affiliative and     prosocial behavior via effects on stress reactivity, neuroendocrine function and sleep.     Finally, it will explore (c) the potential mediating role of stress physiology. To test these     hypotheses, 110 subjects with chronic hepatitis C virus infection will be randomized to     receive treatment with pegylated IFN-alpha plus ribavirin or to postpone treatment for 6     weeks: 55 subjects at University of Arizona and 55 subjects at Emory University. Prior to     randomization and 6 weeks later all subjects will be evaluated with the EAR and sleep     actigraphy in their home environments and will undergo TSST and 14 hour diurnal     neuroendocrine and immune measurement.   "
126779|NCT01625637|"     This is a two part study. In Study 2, smokers who want to quit smoking will participate in a     4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with     weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will     exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach     Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who     are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach     tendencies in the AAT test trials and the Implicit Association Task, when compared to     adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent     smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have     better abstinence rates compared to those who receive placebo AAT training with CBT.   "
126780|NCT01625624|"     The purpose of this study is to determine the effect of food products varying in composition,     on energy in healthy adult subjects.   "
126768|NCT01625780|"     Ilio-inguinal nerve blocks have a long history of efficacy in treatment of post-operative     pain following inguinal surgery. Several anatomic studies have shown that the nerves     supplying the inguinal area have a certain degree of variability with respect to their     location between the internal and external oblique layers of the anterior abdominal wall.     Furthermore, the standard single-shot approach to ilio-inguinal nerve blocks has a     significant incidence of unintended femoral nerve block, which can impair patients' ability     to walk after surgery. The investigators are proposing a new approach to the ilio-inguinal     nerve block, which divides the total dose of local anesthetic into 3 equal parts, injecting     each 1/3 into different layers of the anterior abdominal wall and sub-cutaneously. The     investigators intend to show that this new technique, the Tsui approach, provides equal     analgesia to the standard single-shot ultrasound-guided ilio-inguinal nerve block, while     being faster to perform and having a lower incidence of unintended femoral nerve blockade.     Patients under age 10 who are scheduled for elective inguinal surgery (hydrocele repair,     orchidopexy, and inguinal hernia repair), who have already consented to an ilio-inguinal     nerve block that is commonly placed for this type of procedure, will be approached to     participate in this study. No increased risk is anticipated for these patients, as both     ultrasound-guided and blind techniques are equally well-accepted in the literature for this     type of block, and in addition there are few vascular or neural structures in this anatomical     area (just medial and inferior to the anterior superior iliac spine) that may be damaged.     Follow-up will be limited to an assessment of pain scores in the PACU post-operatively and     any unintended femoral nerve blockade in post-PACU. This will not delay their hospital     discharge as these are same-day surgery patients.   "
126769|NCT01625767|"     This is a two part study. Study 1 will compare Approach Avoidance Training (AAT) responses in     smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive bias     towards tobacco-related stimuli.   "
127852|NCT01611584|"     The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant     tissue.   "
126770|NCT01625754|"     Many studies have shown that those with coronary artery disease (CAD) have a more rapid     decline in memory than expected and that they are at an increased risk of developing     dementia. It is not understood how memory decline is linked to CAD; however, it has recently     been discovered that certain byproducts of fat breakdown involved in the development of CAD,     called ceramides, can harm brain cells. In the present study the investigators will recruit     129 CAD patients from a cardiac rehabilitation facility and measure memory performance and     blood ceramide concentrations at baseline, 3 months and 6 months. The investigators will also     measure important blood messengers of inflammation and assess whether they are associated     with ceramide production. In addition, relationships between ceramides and other aspects of     brain function, such as thinking speed and the ability to plan and sort information will be     explored.   "
126771|NCT01625741|"     This study explores the potential to improve the quality of response obtained after induction     treatment in Chronic Lymphocytic Leukemia (CLL), by giving a short and intense consolidation     schema using high-dose rituximab. Patients in suboptimal response (Minimal Residual Disease     persistence) after induction will be selected, as well as those who have a Minimal Residual     Disease (MRD) relapse after having achieved MRD negativity.   "
126772|NCT01625728|"     The purpose of the study A comparison of vocal demands with vocal performance among     classroom teachers is to gather information about the voice production of teachers using     three separate strategies: (a) measures of voice assessed with the Computerized Speech Lab     (CSL) and the Phonatory Aerodynamic System (PAS) instruments in the SIUC Voice Lab.   "
126773|NCT01625715|"     The primary objective of this study is to evaluate, compared to non-treatment, the impact of     a titrated dose (1 mg once a day, then 1 mg twice a day and finally a full 2 mg twice a day)     of ketotifen on the adverse event profile emerging from a rapid peanut desensitization     protocol, in children with established peanut allergy.   "
126774|NCT01625702|"     To identify the correlation of CTCs with clinical prognosis in advanced/metastatic gastric     cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.   "
126775|NCT01625689|"     In this Phase II randomized controlled clinical trial, generally healthy male and female     children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh.     The study is expected to continue for at least 6 months following vaccination. The     experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live     Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to     WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is     administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable     sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited     in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in     appearance to the active vaccine.      The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24     through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among     children receiving study vaccine as compared to children receiving placebo.   "
126776|NCT01625676|"     The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia     Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT     versus standard treatment with the same intensity of intervention.   "
126777|NCT01625663|"     Barth syndrome (BTHS) is an X-linked disorder caused by abnormal cardiolipin metabolism and     is characterized by skeletal and cardiomyopathy and high mortality rates. Through clinical     metabolism and imaging studies and pluripotent stem cell induction and molecular techniques     on skin biopsy samples, this project will produce novel translational information regarding     the pathogenesis of BTHS, reveal potential targets for interventions and provide unique data     regarding nutrient metabolism and abnormal cardiolipin and mitochondrial function. This     project has the potential to provide information that could significantly improve morbidity     and mortality in children and young adults with BTHS and may have relevance to other non-BTHS     related conditions such as aging and adult heart failure.   "
126778|NCT01625650|"     The CORRONA CERTAIN Sub-study of the Consortium of Rheumatology Researchers of North America,     Inc. is a Sub-study of the CORRONA Data Collection Program.      The CERTAIN Sub-study is designed to systematically collect and document use patterns,     effectiveness, comparative effectiveness and safety of biologic agents used in the management     of Rheumatoid Arthritis (RA).   "
126810|NCT01625234|"     This is the first human study to use X-396 (ensartinib), a drug being developed for treatment     of advanced cancers. The initial purpose of the study is to determine the largest amount of     X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended     Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor     activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide     early information on how the body handles the drug (pharmacokinetics) and on the efficacy of     X-396.   "
128452|NCT01603732|"     The goal of this study is to find out if there is any association between a mother's exposure     to bacteria that normally causes strep throat and her baby's developing heart disease/heart     defect.   "
126781|NCT01625611|"     The primary purpose of the study is to increase our knowledge of receptor function in the     brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has     been approved for the treatment of alcohol dependence. Receptors are special molecules in the     brain to which other molecules (neurotransmitters) attach during the normal every-day     workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence     suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking     behavior. This study will try to determine if naltrexone's ability to attach to these     receptors is related to its effectiveness. We will use PET (positron emission tomography) for     this study. PET is a type of imaging device found in nuclear medicine. It is used for     tracking the presence of injected radioactive materials in the body.   "
126782|NCT01625598|"     The hypothesis is that computer detection of the severity of diabetic retinopathy including     the presence of clinically significant macular edema is not inferior to the detection using a     dilated eye examination by a Board-certified ophthalmologist.   "
127731|NCT01613157|"     The investigators would like to carry out this study to measure drug levels in HIV-infected     women that are taking anti-HIV medications. This study will determine the predictors of high     drug levels and will assess the association of drug levels and adverse events in women.   "
126785|NCT01625559|"     The purpose of this study is:        -  To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD          Group        -  When-MA09-hRPE cell transplantation to evaluate the safety of surgical procedures.        -  In future studies intended to assess the number of transplanted hRPE cells.        -  In the past, MA09-hRPE cell therapy used in the study was to evaluate the validity of          the potential.        -  Homologous retinal pigment epithelial cells derived from embryonic stem cells, future          studies of drugs that are used in representing the potential validity to evaluate the          optimal dose.   "
126786|NCT01625546|"     Major depressive disorder (MDD) is predicted to be the second leading cause of disability     worldwide by the year 2020. The economic burden of depression in the United States is     significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high     rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD     patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients     will fail to adequately respond to all currently available interventions. Moreover, current     treatments come at the cost of significant central nervous system (CNS) side effects, further     highlighting the need for more effective treatments with fewer side effects. This study will     compare temperature ranges from the investigators preliminary studies involving     thermoafferent pathways resulting in antidepressant actions with lower temperature ranges not     expected to activate these pathways as a control condition, with the goal to evaluate whether     previous observations were related to the temperature range in question or can be achieved     with other levels.   "
126787|NCT01625533|"     The purpose of this study is to assess the clinical safety and efficacy of dual-axis     rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by     directly comparing it to standard coronary angiography (SA).   "
126788|NCT01625520|"     A mono centre study to evaluate the efficacy of SOM230 in patients with progressive     metastatic or postoperative persistent medullary thyroid cancer.   "
126789|NCT01625507|"     The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA     intervention, will have improved compliance with the nutritional therapy recommendations of     the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of     the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a)     to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention     program that promotes the individual factors required for effective self-management practices     AND that explicitly incorporate strategies to improve food availability, accessibility and     acceptability and (b) to use these interventions as a means to examine the relationships     between food availability, accessibility, acceptability, adherence to Nutrition Therapy     Guidelines, and metabolic indicators of diabetes control in people with type 2 diabetes.   "
126790|NCT01625494|"     Primary Objective:      - To assess the proportion of patients with controlled Office Blood Pressure Measurements     (OBPM), defined as Systolic blood pressure < 140 mmHg and Diastolic blood pressure <90mmHg,     at the end of the study      Secondary Objectives:        -  To examine over time the antihypertensive effect of the 4 doses of the fixed combination          therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic          blood pressure)        -  To examine the proportion of patients with controlled OBPM (systolic BP<140 mm Hg and          diastolic BP<90 mmHg) of the different dose groups over time        -  To determine the incidence and severity of adverse events.   "
126791|NCT01625481|"     The purpose of this study is to further assess the safety and performance of Seal-V as an     adjunct to standard surgical procedure for achieving hemostasis in patients undergoing     peripheral vascular reconstruction surgeries using synthetic grafts.   "
126811|NCT01625221|"     The purpose of this feasibility study is to obtain preliminary safety and effectiveness     information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX     System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).   "
126826|NCT01625026|"     By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but     presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in     laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high     affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and     glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively,     that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS)     surgery where in addition to blood samples also biopsies are taken from the liver and in the     case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.   "
126792|NCT01625468|"     The burden of tobacco use falls disproportionately on low-income populations, through high     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in     creating smoke-free environments in the U.S. over the past two decades has left smoker's     homes as one of the primary sources of exposure to secondhand smoke for both children and     nonsmoking adults. Intervention research that identifies effective and practical strategies     for reaching the minority of households that still allow smoking in the home has considerable     potential to reduce smoke exposure, but suitable channels to reach low-income families are     limited. The proposed research will develop, evaluate and disseminate a brief smoke-free     homes intervention through the established national infrastructure of 2-1-1 call centers.     2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies     or 4-1-1 for directory assistance, that links callers to community-based health and social     services.      The proposed research has four specific aims: 1) Conduct formative research on intervention     messages and materials for promoting smoke-free homes in low-income populations, applicable     to both smokers and nonsmokers as household change agents; 2) Conduct a randomized controlled     trial in the Atlanta 2-1-1 service area to evaluate the efficacy of a brief intervention to     create smoke-free homes among 2-1-1 callers; 3) Conduct replication studies in Houston and     North Carolina 2-1-1 systems to systematically test the intervention in varied populations     and tobacco control climates, and 4) Disseminate the research-tested smoke-free homes     intervention through a variety of mechanisms including a national grants program to 2-1-1     systems and through the Tobacco Technical Assistance Consortium's linkages to the state and     local tobacco control infrastructure in the U.S.   "
126793|NCT01625455|"     The purpose of this randomized, double-blinded, placebo-controlled study is to test the     hypothesis that administration of aprepitant will decrease the severity of pruritus in     patients with Sèzary Syndrome.   "
126794|NCT01625442|"     The metabolic syndrome is associated with increased risk of cardiovascular disease and     diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States     is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators     to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit)     in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL     cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after     45 days of treatment.   "
126795|NCT01625429|"     This is a single-center, prospective, single arm phase II study to evaluate the efficacy and     safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as     neoadjuvant therapy in operable locally advanced breast cancer patients. The primary     objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample     size is 30.   "
126796|NCT01625416|"     After traumatic injuries some people have difficulty returning to the routine of their     everyday activities and may experience physical and emotional pain. The purpose of this study     is to identify new ways of providing support for physically injured trauma survivors. All     study procedures are designed to work around patient needs and be as flexible as possible in     order to best fit into patients' post-injury recovery.      Patients who are eligible for the study are randomly assigned to receive care as usual, or     the new method of treatment, with the study Trauma Support Specialist (TSS). This TSS will     be in contact with the patient for the next three months; they may visit the patient at the     hospital or at outpatient medical appointments. The TSS will also be available to talk with     the patient over the telephone. Overall, the TSS will be working with the patient to help     with difficulties returning to his or her routine and overcoming physical and emotional pain     experienced after the injury. We believe that patients who receive the new method of     treatment, will be more able to return to daily routines and/or cope with the emotional     stress that can occur after an injury. Intervention technology innovations including mHealth     applications and web-based links will be included in the investigation.   "
126797|NCT01625403|"     The purpose of this study is to evaluate the efficacy and safety of recombinant human B-type     natriuretic peptide (rhBNP) on heart and renal function in patients with acute decompensated     heart failure (ADHF) and acute renal injury (AKI).   "
126798|NCT01625390|"     Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one     of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient     levels. In a person with haemophilia, the clotting process is much slower and the person     experiences bleeding episodes that can result in serious problems and potential disability.      The current haemophilia standard of care is to maintain FVIII activity level above 1%.     Sometimes, patients can develop antibodies (so called inhibitors) against FVIII and it is     no longer effective at controlling bleeds. Bleeds in these patients are currently treated     using other proteins involved in the clotting process.      The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds     in inhibitor patients. This study consists of two parts, A and B. The purpose of part A is     to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to     efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The     purpose of part B is to confirm efficacy and safety of the dose found in part A in all     participating patients (confirmatory part). Part B is expected to last 12-32 months.      Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or     B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6     months, will participate in this study.      Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response     is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be     required to keep an electronic diary.   "
126799|NCT01625377|"     The aims of the study was to evaluate the safety and efficacy of early introduction one month     post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de     novo liver transplant recipients and to evaluate if it leads to a better renal function 6     month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.      The renal function was estimated by glomerular filtration rate.   "
126812|NCT01625208|"     This study will examine how successfully nerves are blocked or frozen for hand surgery.     Traditionally, the nerves are frozen at the base of the neck, just above the clavicle or     collarbone (the supraclavicular block). This is mostly successful by itself, and provides     anesthesia of the entire arm. Occasionally, an additional nerve block is required further     down the arm, as the supraclavicular block may have missed a segment, or it is taking too     long to come on. In this study the investigators will compare the traditional technique, with     a similar but lower volume supraclavicular block plus an immediate low volume block of one     nerve further down the arm (the ulnar or median nerve block, depending on which digits are     being operated on). The investigators will compare success rates, speed of onset, procedural     comfort and length of time of weakness and numbness, plus any adverse events.   "
126800|NCT01625364|"     The purpose was to evaluate effectiveness and impact of an academic and counseling asthma     health education program (SHARP) for fourth- and fifth-grade students diagnosed with asthma.     Students attending schools randomized to the low-dose control condition received Open Airways     for Schools (OAS). The first aim was to evaluate the effectiveness of SHARP, compared to the     low-dose group, for students on cognitive, psychosocial, and behavioral aspects of asthma     management at 1, 12, and 24 months post-intervention. We hypothesized that compared to     students enrolled in elementary schools who received the low-dose program, students in     elementary schools that received SHARP would increase asthma knowledge (cognition) and     logical reasoning abilities for managing acute episodes (cognition), acceptance of asthma as     a chronic condition (psychosocial), and use of effective asthma health behaviors (behavior).     The second aim was to evaluate the long-term impact of SHARP, compared to the low-dose group,     for students on condition characteristics, use of healthcare services, and quality of life at     12 and 24 months post intervention. We hypothesized that compared to students enrolled in     elementary schools who received the low-dose program; students in elementary schools who     received SHARP would decrease asthma severity, use of healthcare services, and school     absenteeism due to asthma, and increase participation in life activities (quality of life).   "
126801|NCT01625351|"     This is a phase I study designed to determine the feasibility of transplantation using a     novel transplant approach that employs a two-stage haploidentical cell infusion following     myeloablative conditioning. This strategy, which includes selective depletion of naïve T     cells, may speed immune reconstitution thereby potentially reducing the limitations of     traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its     potential therapeutic application. Additionally, the investigators intend to explore overall     survival, event-free survival, hematopoietic cell recovery and engraftment as well as     infection rates and complications in these patients.   "
126802|NCT01625338|"     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)     in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults     with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study     and have not achieved sustained virologic response (SVR).   "
126803|NCT01625325|"     While obese and extremely obese youth are at increased risk of health complications,     especially the extremely obese group rarely seek medical care. One of the underlying reasons     might be the lack of adequate treatment options. This study is a subproject of the Medical     and psychosocial implications of adolescent extreme obesity - acceptance and effects of     structured care study, short: Youth with Extreme obesity Study (YES), which aims at     improving the medical care and social support structures for youth with obesity and extreme     obesity in Germany. In this subproject, information on the causes and consequences of extreme     obesity will be gathered via questionnaires and medical examinations.      Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially     up to 21 years) are eligible to participate. Participants will be asked to complete a series     of questionnaires on their general health, psychosocial situation and wellbeing in 2-3     sessions. They will be offered a thorough medical examination comprising a general check-up,     a fasting blood draw and oral glucose tolerance test, a focused orthopaedic examination, a     sleep apnea screening, and an ultrasound of the liver. The aim of the study is to elicit the     acceptance of diagnostic and therapeutic procedures, and to assess the frequency of     co-morbidities in obese and extremely obese youth. This knowledge will optimize medical     treatment and support options. Interested participants will be invited to participate in     further steps of YES, which entail medical care and psycho-social support.   "
126804|NCT01625312|"     Coronary heart disease (CHD) pose a serious health threaten to population. Optimal     revascularization strategy in multiple vessel coronary artery disease patients remains a     subject of debate between interventional cardiologists and surgeons. Knowledge about the     real-life revascularization pattern and outcomes in China is limited. By consecutively     recruiting three vessel coronary heart disease patients in 25 geographically representative     highest-rank hospitals, this study will examine revascularization strategy, and various     real-life factors, that may affect patients lone-term recovery. Practical guidelines,     appropriateness criteria and quality evaluative system for revascularization strategy will be     established based on the findings, to improve patients outcomes in future finally.   "
126805|NCT01625299|"     We hypothesize that in children with autism dietary antigens can change the intestine, making     it leaky and then affecting the brain changing their behavior.   "
126806|NCT01625286|"     The purpose of this study is to investigate the safety and efficacy of different doses and     schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with     advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of     AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in     treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer,     including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide     (PIK3CA) tumour mutation.   "
126807|NCT01625273|"     The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant     formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.   "
126808|NCT01625260|"     This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801     combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing     or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to     undergo a radical cystectomy recommended by the participating urologist as the standard next     therapy per urologic guidelines. The purpose of this study is to confirm the safety and     tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose     level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in     treated patients. The anti-tumor responses will also be assessed.   "
126809|NCT01625247|"     Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The     role of routine drainage after LC to decrease postoperative morbidity is still an issue of     considerable debate. The goal of this study was to assess to role of drains in LC, performed     for acute inflamed gallbladder.   "
127076|NCT01621737|"     The objective of the study is to compare the efficacy of intranasal oxytocin versus     intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms     despite being on adequate treatment with antipsychotic medication.   "
126813|NCT01625195|"     Nutrition is key to healthy aging for a number of diseases but the investigators have     reported imbalances in the distribution of long chain omega-3 fatty acids (LC-omega-3) in the     elderly and in the carriers of apolipoprotein E epsilon 4 (APOE4) isoform. Carrying APOE4     isoform is currently recognized as being the most important genetic risk factor of cognitive     decline. The investigators believe that dysregulation of LC-omega-3 metabolism is intimately     link with higher risk of cognitive decline. The current project will investigate whether     there is a causal relationship between LC-omega-3-enriched diet and cognition using, on the     one hand, a randomized double-blind placebo-controlled design and on the other hand,     transgenic mice carrying human APOE4. In both study, the investigators will focus     specifically on the distribution (level) of LC-omega-3 into lipoproteins with age and/or     APOE4 isoform to evaluate whether dysfunctional transport of LC-omega-3 is associated with     lower cognitive scores on visuospatial capacity, verbal fluency or working memory. In APOE4     mice, the investigators will evaluate LC-omega-3 brain uptake together with the level of     LC-omega-3 in the brain membranes and the level of APOE protein within the brain. The present     investigation will provide key basis for understanding how to develop nutritional strategies     for healthy aging and the preservation of cognitive function.   "
126814|NCT01625182|"     The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of     chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.   "
126830|NCT01624974|"     The purpose of this study is to evaluate the effect of MK-1029 on lung function in the     treatment of adults who have persistent asthma that is uncontrolled with the use of     montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for     two separate 4-week treatment periods. All participants will also use ML during the treatment     periods.   "
127732|NCT01613144|"     This is an Open-label, prospective, randomized, multi-center post-market study.   "
126815|NCT01625169|"     HIV positive pregnant women who receive potent combination antiretroviral therapy over at     least the last trimester of pregnancy, and who have proper obstetric interventions and are     able to avoid breast feeding, decrease the risk of having an infected infant to about 1%.     Breast milk HIV-1 RNA (cell free) viral load is significantly associated with breast milk     transmission, and a 2-fold increased risk of transmission associated with every 10-fold     increase in breast milk viral load has been reported. In addition, cell associated virus (HIV     DNA) was associated with a significant increase in risk of transmission independent of the     level of cell-free viral RNA.      However, multiple studies of HIV positive women giving birth have shown that exclusive     breast-feeding carries a much lower risk of HIV transmission than mixed breast-feeding     (defined as breast milk along with complementary food, other milk, and/or infant formula).     The proposed study will measure the antiretroviral (ARV) drug etravirine concentrations in     blood and breast milk in postpartum HIV positive women on HAART therapy. The short-term goal     is to determine how much etravirine penetrates into breast milk, and whether it leads to     undetectable HIV viral load in the breast milk and therefore has the potential to decrease     the risk of transmission of HIV through breast milk. The long term goal is to see if breast     milk HIV levels can be lowered sufficiently to prevent maternal to child transmission (MTCT)     of HIV in infants receiving only breast feeding in resource poor areas.   "
126816|NCT01625156|"     This phase I trial studies the side effects and best dose of tivantinib when given in     combination with temsirolimus in treating patients with solid tumors that have spread to     other parts of the body or cannot be removed by surgery. Tivantinib and temsirolimus may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
126817|NCT01625143|"     This laboratory study is looking into genes in samples from younger patients with relapsed     acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.   "
126818|NCT01625130|"     Purpose: To determine if modulation of NRF2 with a Sulforaphane enriched supplement modifies     responses to O3. Participants: Recruitment of up to 70 healthy volunteers, ages 18-50, for     completion of 36 volunteers. Procedures: This is a randomized, placebo controlled 2x2     crossover study of treatment with an NRF2 modifier versus placebo in healthy volunteers which     will examine airway inflammation before and 4 hours after a 2 hour 0.4 ppm O3 exposure.     Participants will be randomized to received either the NRF2 modifier, SFN oral supplement     (i.e. broccoli sprout shake), or placebo (alfalfa shake) for 3 days followed by a 0.4 ppm O3     exposure for 2 hours. At least 2 weeks later subjects will return for a 2nd supplementation     treatment (using the alternative supplement to that provided initially) followed by an ozone     exposure identical to the initial one.   "
126819|NCT01625117|"     The purpose of this study is examine, whether a treatment approach, which is specifically     tailored for perpetrators who have participated in violence (a variant of Narrative Exposure     Therapy) is effective in the reduction of instrumental aggression and symptoms of     posttraumatic stress disorder.   "
126820|NCT01625104|"     The primary objective of this study is to assess whether an aggressive quality improvement     intervention strategy will decrease time from hospital presentation to first balloon     inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with     primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were     randomized to either aggressive intervention or control. The intervention consisted of Grand     Rounds at each hospital, sharing of best practices, and coordinating center staff working     closely with staff at each intervention hospital to discuss solutions to barriers to rapid     treatment for STEMI patients.   "
126821|NCT01625091|"     The primary objective of this study is to evaluate whether an intervention that involves the     medication naltrexone, will reduce drinking and improve health outcomes in women with HIV     infection and hazardous drinking. Our central hypotheses are that, compared to women who     receive placebo (sugar pill containing no medicine), women who receive naltrexone will have     decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease     progression, and reduced sexual risk behavior. The study design will involve 240 HIV-infected     women with hazardous drinking, who will be recruited from HIV clinics, neighborhoods and     referrals in Miami, Florida.      Eligible women will receive either a daily pill containing naltrexone (50mg) or an     identical-appearing placebo for four months. All participants will receive encouragement and     feedback related to their drinking regardless of medication assignment. The study     participants will be assessed at two, four and seven months after enrollment. The proposed     work is innovative because pharmacologic treatment for alcohol has not been evaluated in     HIV-infected women. If our hypotheses are confirmed, the study findings would transform the     approach to hazardous drinking within clinics serving HIV-infected women.   "
126822|NCT01625078|"     The investigators wish to accumulate initial data on the performance and safety of the Baska     mask in paediatric patient population.   "
126827|NCT01625013|"     This study aims to study use of viscosupplementation as a treatment of pain for young     individuals who are active. Typically viscosupplementation is considered an intervention for     knee osteoarthritis often for older patients who are less active. Many young active patients     can also develop knee osteoarthritis after trauma or surgery or for congenital reasons.     Treatment of these patients commonly are steroid injections which have more biologically     detrimental effects for cartilage compared to viscosupplementation Synvisc One injections     which are a single injection will be used to determine effectiveness of reducing pain and     maintaining an active healthy lifestyle for younger patients aged 30-50 years old.   "
126828|NCT01625000|"     The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214     relative to placebo in patients with acute exacerbation of schizophrenia.   "
126829|NCT01624987|"     The project aims to investigate if trauma-related disorders and appetitive aggression can be     reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure     Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local personnel     (phase 1). In a second step, the project aims to investigates the treatment success if this     specific therapy is carried out by local personnel who have been trained by other local     personnel (train the trainer, phase 2) under the supervision of experts of the University     of Konstanz.   "
126832|NCT01624948|"     This study is examining the safety and efficacy of converting anti-rejection therapy from     mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus     infection.      The study will also determine if immune monitoring tests can detect an association between BK     virus infection and transplant rejection episodes, based on the specific BKV infection     treatment regimen.      The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and     tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and     tacrolimus + prednisone in patients who have undergone renal transplantation and have active     BKV infections.   "
126833|NCT01624935|"     The enormous global burden of mental illness has been estimated through the publication of     the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma     such as natural disaster bear a particularly high burden of mental disorders, with depression     and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric     diagnoses. In traumatized populations, these disorders do not remit with replacement of     material losses or resettlement to safe locations, but rather tend to become chronic     conditions with attendant disability. PTSD and depression are risk factors for anger,     interpersonal discord and violence, not only among those who have trauma and depression, but     also among their spouses and children. This infectious model of trauma/violence is     critically important in the setting of natural disaster, as increased levels of interpersonal     violence within the afflicted community hinder its recovery. To date, there has been little     research on the interpersonal effects of mass trauma. The proposed research is a randomized     controlled trial of Interpersonal Therapy (IPT) versus wait list control (WLC) for     survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy     for depression, has been adapted for PTSD treatment and developing country settings. Measures     will evaluate success of the treatment not only in terms of individual depression and PTSD     symptoms, but also with respect to interpersonal functioning.      Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet     criteria for Depression and PTSD at the conclusion of the RCT.      Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning     than wait list controls.   "
126834|NCT01624922|"     Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a     well-proved and booming measure in CHD management, is invasive and of high cost, however the     knowledge about the real-life PCI use in China is limited. By consecutively recruiting PCI     patients in 30 geographically representative highest-rank hospitals, this study will examine     various real-life factors, that may affect patients recovery after the procedure. Practical     guidelines, appropriateness criteria and quality evaluative system for PCI will be     established based on the findings, to improve patients outcomes in future finally.   "
126835|NCT01624909|"     Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women,     however little information is available about how evidence-based therapies are incorporated     appropriately into routine clinical practice in China. In addition, basic data and evidence     about safety and efficacy of treatment for AMI is limited. By consecutively recruiting AMI     patients in 40 hospitals of different levels, this study will examine various real-life     factors, that may affect patients recovery after a heart attack. Practical guidelines and     risk model for AMI patients will be established based on the findings, to improve patients     outcomes in future finally.   "
126836|NCT01624896|"     Coronary heart disease (CHD) is one of the leading causes of mortality and morbidity. PCI, as     a well-proved and booming measure in CHD management, is invasive and of high cost, however     the knowledge about the real-life PCI use in China is limited. Within a nation-wide and     regional representative probability sample of hospitals in China, 14,000 CAG/PCI inpatient     cases will be sampled randomly from 2001 to 2011. The sampled medical records will be     reviewed and abstracted in the national coordinating centre, in order to evaluate the     treatment pattern, outcomes, and cost for PCI, during the past decade. Basic data and     innovative evidence will accelerate evidence-based clinical practice and policy making, and     improve patients outcomes in future finally.   "
126883|NCT01624285|"     The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and     effective treatment option for preventing liver cancer in high risk patients following liver     transplantation. Liver transplantation is a treatment option for liver cancer patients, but     despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not     known whether sorafenib is effective in preventing cancer recurrence in high risk patients     following liver transplantation   "
126837|NCT01624883|"     Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women,     however the knowledge about the real-life AMI management in China is limited. Within a     nation-wide and regional representative probability sample of hospitals in China, 27,800 AMI     inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will     be reviewed and abstracted in the national coordinating centre, in order to evaluate the     treatment pattern, outcomes, and cost for AMI patients, during the past decade. Basic data     and innovative evidence will accelerate evidence-based clinical practice and policy making,     and improve AMI patients outcomes finally.   "
126838|NCT01624870|"     The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with     the Medtronic CoreValve bioprosthesis.   "
126839|NCT01624857|"     Depression is frequently observed in patients with coronary heart disease (CHD) and     represents a significant risk factor for major cardiovascular events. Previous study has     proved that high sensitive C-reactive protein (hsCRP) was an independent predictor for     depression in CABG patients at 6 months after bypass surgery. Statins can effectively reduce     the blood levels of hsCRP. This study aim to examine whether statins can improve the     prognosis of depressive patients undergoing coronary artery bypass surgery through reducing     the levels of hsCRP.   "
126840|NCT01624844|"     The purpose of this study is to investigate whether the dural sac volume as determined by a     geometrical calculation following multilevel measurements of its transverse area and length     by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric     bupivacaine in a non-obstetrical population.   "
126889|NCT01624207|"     The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded     formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean     patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher     in Atorva group. Both treatments were well tolerated.   "
126841|NCT01624831|"     In the current study, the investigators propose to measure the five domains of social     cognition identified by the National Institute of Mental Health (NIMH) as relevant to     individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition,     social perception, and social knowledge). The investigators will also explore the association     between different domains of social cognition and outcomes relevant to psychotic disorder     (e.g., symptomatology, social functioning, and vocational functioning).   "
126842|NCT01624818|"     Background: In Norway each year 130-150 children are born with heart disease that requires     lifelong medical follow-up. Children with heart defects have reduced motor skills and reduced     physical capacity compared with healthy peers. Increased knowledge in the children themselves     and the general public, along with psychosocial interventions improve the child's ability to     cope with the consequences of their disease. Descriptions of the experiences that Norwegian     children with heart disease and their parents have about participation in rehabilitation     programs is limited. Geilomo children's hospital has 75 years experience in rehabilitation of     children with chronic illness, and started in 2005 to welcome children with heart disease. At     present there is no rehabilitation institutions in Norway that has a special group programs     for children with heart disease. Geilomo want to establish such a group for children aged 6-7     years and 11-12 years.      Main objective: The investigators will use of methods to learn more about the following:      Study 1: The purpose is to generate knowledge about how children with heart disease and their     relatives experience participation in a rehabilitation program at Geilomo children's     hospital.      Overarching question: How do children with heart disease and their guardians to participate     in a rehabilitation program, and the impact of this on their daily life afterwards?      Study 2: The purpose is to help a) to give the children an increased level of activity in the     home environment.      Question: Will children with heart disease increase their activity levels at home after a     stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will     children with heart disease have improved their physical condition three months after a stay     at Geilomo?      Work schedule: The project will have a duration of 3 years. The project will seek approval of     the Regional Committee for Medical Research Ethics in May 2012. Interview Guide, information     sheet and consent form has been prepared. Data collection for the study 2AB can start in     March 2013. The first interviews will be conducted after 3 months, in June 2013. Data     collection is expected to be completed in December 2013. The analysis will take place in     parallel with the interview work. In 2014 and 2015 completed the writing of articles (3     pieces) and publication of results.      Method: In order to shed light on the problem in study 1, the investigators will use     semi-structured interview. 16 children and 16 parents to be interviewed after 3 months. Study     2a) To get information about their child's activity level in the home environment the     investigators will use structured questionnaires. It is one form for children (36 persons)     and another form for their parents (36 persons). Study 2b) All children (36 persons)     conducting physical fitness test at the first visit and after three months. Children can be     referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle     Hirth (HUS) determines participation according to inclusion and exclusion criteria.      Parents submit a written consent on behalf of themselves and their children.      Scientific significance: This application describes two related studies, both of which are     expected to provide important information that can provide better services for children with     heart disease.   "
126843|NCT01624805|"     The goal of this clinical research study is to learn if horse anti-thymocyte globulin (hATG),     given in combination with methylprednisolone, cyclosporine, and G-CSF (filgrastim or     pegfilgrastim), can help to control AA and/or low-int-1 risk MDS. The safety of this drug     combination will also be studied.      hATG is made from horse blood and targets immune cells known as T-lymphocytes. Since     T-lymphocytes are believed to be involved in causing low blood counts in AA and in some cases     of MDS, killing these cells may help treat the disease.      Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This     may help to improve low blood counts in AA and in some cases of MDS.      Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help     to fight infections and help improve the white blood cell count.   "
126844|NCT01624792|"     Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive     Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD     unless specific metabolic abnormalities are targeted. The investigators recently observed     that alterations in protein metabolism are present in normal weight COPD patients. Elevated     levels of protein synthesis and breakdown rates were found in this COPD group indicating that     alterations are already present before muscle wasting occurs. The investigators recently     observed that in order to enhance protein anabolism, manipulation of the composition of     proteins and amino acids in nutrition is required in normal-weight COPD. Intake of casein     protein resulted into significant protein anabolism in these patients. The anabolic response     to casein protein was even higher than after whey protein intake.      A substantial number of COPD patients, underweight as well as normal weight to obese, is     characterized by an increased inflammatory response. This group failed to respond to     nutritional therapy. Previous experimental research and clinical studies in cachectic     conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to     attenuate protein degradation by improving the anabolic response to feeding and by decreasing     the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic     acid (DHA)) has been shown to effectively inhibit weight loss in several disease states,     however weight and muscle mass gain was not present or minimal.      Until now, limited research has been done examining muscle protein metabolism and the     response to EPA and DHA supplementation in patients with COPD.      It is the investigator's hypothesis that supplementation of 2g/day EPA+DHA in COPD patients     during 4 consecutive weeks will increase the muscle anabolic response to a high quality     protein supplement as compared to a placebo, and supplementation of 3.5g/day EPA+DHA will     increase the anabolic response even further. In the present study both the acute and chronic     effects of EPA+DHA versus a placebo on muscle and whole body protein metabolism will be     examined. The principal endpoint will be the extent of stimulation of net fractional muscle     protein synthesis as this is the principal mechanism by which the effect of EPA+DHA on muscle     anabolism can be measured. The endpoint will be assessed by isotope methodology which is     thought to be the reference method.   "
126845|NCT01624779|"     The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal     stem cells in the patients with spinal cord injury, Phase I Clinical study.   "
126953|NCT01623362|"     The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride     concentration in liquid dentifrices in the control of dental caries in early childhood, in     non-fluoridated area. This study also aims to assess the effect of the consistency of liquid     dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the     toenails, to estimate the fluoride intake from these formulations.   "
126846|NCT01624766|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of Afinitor (everolimus) either with Kineret (anakinra) or Xgeva (denosumab) that     can be given to patients with advanced cancer. The safety of these drugs will also be     studied.      Everolimus is designed to stop cells from dividing.      Anakinra is designated to block a protein that is involved in tumor development, new blood     vessels growing, and spread of cancer.      Denosumab is designed to block the activity of a protein, which may prevent bone     complications in cancer that has spread to the bone.   "
126847|NCT01624753|"     Fibered confocal fluorescence microscopy (FCFM) (CellvizioR Lung, MaunaKea Technologies,     France) could potentially provide diagnostic information on fibrosis and inflammation of the     distal air spaces associated with diffuse parenchymal lung diseases without the need for lung     biopsies, thereby fulfilling the gap in the investigators current medical practice of a     minimally invasive procedures with few complications and a high diagnostic fidelity.      In patients scheduled for bronchoscopy as part of regular clinical care/diagnostic workup,     the investigators will offer the patient concurrent FCFM imaging to be performed during the     bronchoscopic procedure. The investigators aim to identify and catalogue distinct and     discriminating features seen on images obtained from fibered confocal fluorescence microscopy     in this group of patients, and to correlate these findings with specific high resolution     computed tomography (HRCT) features and pathological findings if available. Eventually the     investigators hope to create diagnostic criteria for fibered confocal fluorescence microscopy     image interpretation of specific diffuse parenchymal lung disease entities.   "
126850|NCT01624714|"     The purpose of this study is to treat prospectively documented clinic patients with     treatment-refractory multiple sclerosis that are naïve to alemtuzumab. Alemtuzumab shows     efficacy and rate of serious adverse events (SAEs) which is equivalent or better than     standard of care treatment strategies used previously for treatment-refractory multiple     sclerosis.   "
126851|NCT01624701|"     This is a pilot clinical trial to assess the feasibility and efficacy of expanding umbilical     cord blood derived blood stem cells for transplantation using a combination of chemical     factors and stromal co-culture. Bone marrow (BM) mesenchymal stromal cells (MSC) will be     obtained from a separate bone marrow donor. One cord blood unit will be expanded by this     method while another cord blood unit will be infused without manipulation. The expanded cord     blood unit will help boost the initial recovery of blood counts after transplantation, though     it is expected that the unexpanded cord blood unit will provide the cells which will lead to     long term engraftment of blood stem cells. A third cord blood unit will be identified for     standby should the cord blood unit expansion fail.   "
126852|NCT01624688|"     The purpose of this study is to combine treatment options for tattoo removal in an attempt to     completely remove a tattoo in one visit.   "
126853|NCT01624675|"     The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in     children and adolescents with irritability associated with autistic disorder.   "
126854|NCT01624662|"     The primary objective of this study is to compare the efficacy of intranasal administration     of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose     device with placebo in subjects with bilateral nasal polyposis.   "
126855|NCT01624649|"     The purpose of this observational study is to explore the efficacy of methylphenidate     hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity     disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time     version (K-SADS-PL).   "
126856|NCT01624636|"     This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and     efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular     age-related macular degeneration (AMD)   "
126857|NCT01624623|"     This study will evaluate the daily use of a unique daily organ tracking system on target     localization in patients treated with radiation therapy after radical prostatectomy for     prostate cancer.      Improved coverage of the target volume with radiotherapy could result in improved cancer     control rates and decreased coverage of surrounding structures potentially decreasing     treatment toxicity.   "
126858|NCT01624610|"     The purpose of the study is to find out if the diets often recommended for patients with     Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will     compare two diets that are used to treat IBS-D symptoms to see which one is more effective.     The study will also measure the effect of these diets on the bowel flora, which are the good     bacteria that inhabit the bowels in healthy people.   "
126859|NCT01624597|"     This randomized controlled trial will evaluate an intervention that provides parents with     objective feedback about their teen's driving as well as strategies to improve communication     with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent     or guardian. Our main hypotheses are that: parent-teen dyads who receive feedback will have     reduced driving errors and increased safety behaviors than dyads with no feedback; and,     parent-teen dyads who receive instruction on communication techniques will have improved     quality and quantity of communication about driving than dyads not learning these techniques.   "
126860|NCT01624584|"     First, can exposure therapy for childhood anxiety begin earlier in the course of treatment     than current treatment manuals suggest?      Second, is treating childhood anxiety with exposure therapy more effective and efficient than     treating childhood anxiety with relaxation training + cognitive restructuring?   "
126861|NCT01624571|"     This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement of     gastrointestinal motility between each dose group by comparing the effectiveness and safety     in patients undergoing colon resection.   "
127060|NCT01621945|"     The main objective of the study is to estimate the proportion of children, born between the     06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with     a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4),     before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.   "
126862|NCT01624558|"     Malignant hyperthermia is a potentially fatal inherited disorder triggered by exposure to     volatile anesthetic gases, most commonly recognized in children during anesthesia. Carbon     filters have been used to scavenge various gases. A new carbon filter (Vapor Clean,     Dynasthetics, LLC, Salt Lake City, Utah) with a 510(k) clearance specifically for scavenging     anesthetic gases is being marketed, though the filter itself has never been studied in vivo.     Bench studies conducted by the manufacturer of the product demonstrate it is extremely     effective in reducing the volatile gas output from an anesthesia machine within 2 minutes.     This pilot study will measure the effect on volatile gas concentration in non-malignant     hyperthermia susceptible patients. Twelve (12) patients will undergo standard anesthetic     induction using inhalational anesthetic (Sevoflurane®) and maintained on 3% for 30 minutes to     attain steady state concentrations.1 At that time, a total intravenous anesthetic technique     will be started and maintained throughout the case. Simultaneously a Vapor Clean filterset     will be placed in the breathing circuit (inspiratory and expiratory limbs). Volatile gas     concentration will be measured and recorded. This research will determine the feasibility of     using this carbon filter to quickly reduce the breathing circuit gas concentration of     volatile anesthetic in the clinical setting. This is fundamental in establishing this as a     key life saving measure in eliminating the stimulus in a malignant hyperthermia event.   "
126888|NCT01624220|"     The goal of the first part of this clinical research study is to learn how to deliver more     accurate radiation treatment of tumors in the spine. Researchers also want to learn how     internal organs might move during radiation treatment.      The goal of the second part of this study is to learn if it is safe to allow slightly more     radiation to the normal esophagus when spinal tumors close by are being treated. This may     result in better tumor control.   "
126912|NCT01623895|"     To investigate effect of genetic variations on the toxicities and find optimal target     population, the investigators planned to analyze the genetic polymorphisms of     UDP-glucuronosyltransferase.   "
126863|NCT01624545|"     Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These     hematomas develop after minor head trauma and increase in size over weeks. Patients usually     present with headaches, gait disturbances, language problems or confusion. The state of the     art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr     hole trepanation.      The optimal follow-up for operated patients remains controversial. Due to the known high rate     of a second hematoma at the same place (usually within weeks), one strategy is to perform     serial computer tomography scans in order to identify recurrent hematomas early. The     radiologic evidence of a second hematoma often leads to reoperation, even if the patient has     no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to     closely follow the patient with neurological examinations and perform neuroimaging only in     case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT     scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a     patient population marked by advanced age and fragility.      The aim of the current study is to evaluate the role of computer tomography scanning in the     postoperative follow-up after removal of a chronic subdural hematoma. Participants of this     study will be allocated by chance to one of two study groups: Patients allocated to group A     will receive a computer tomography scan on day 2 and again on day 30 after surgery in     addition to a clinical examination. Patients allocated to group B will be examined clinically     on day 2 and day 30 without computer tomography. All patients will undergo a final clinical     examination after 6 months. The study will recruit 400 patients.   "
126864|NCT01624532|"     The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the     Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.   "
126865|NCT01624519|"     The main objective of this study is to examine the agreement between arterial, central     venous, and peripheral venous lactate values in a population of medical Intensive Care Unit     (ICU) patients.   "
126866|NCT01624506|"     The Anti-Reflux Surgical Study has been established to:        -  Collect data about anti-reflux surgical treatment options (magnetic sphincter          augmentation and Fundoplication) in everyday clinical practice        -  Track the clinical course of patients from pre-operative assessment to three years          post-surgery   "
126867|NCT01624493|"     This phase I/II trial will determine the recommended dose and activity of BNC105P for     patients with partially platinum sensitive ovarian cancer in first or second relapse.   "
126868|NCT01624480|"     This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and     multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with     excessive sleepiness associated with narcolepsy.   "
126869|NCT01624467|"     The purpose of this study is to determine whether treatment with necitumumab monotherapy     affects the QT/QTc interval among participants with advanced solid tumors refractory to     standard treatment or for which no standard treatment is available.   "
126870|NCT01624454|"     Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel     cleansing, randomizing adult outpatients by invitation letter   "
126871|NCT01624441|"     This phase I clinical trial studies the side effects and the best dose of dinaciclib when     given together with epirubicin hydrochloride (epirubicin) in patients with metastatic (cancer     that has spread to other parts of the body) triple-negative breast cancer. Dinaciclib is     designed to stop cancer cells from dividing into new cancer cells. Epirubicin is designed to     block the way cancer cells grow and divide and may slow or stop cancer cells from spreading     throughout the body. Researchers want to find out what is the highest tolerable dose of the     experimental drug dinaciclib that can be given in combination with epirubicin in patients     with metastatic triple negative breast cancer.   "
126872|NCT01624428|"     This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the     influence of varenicline on reward processing, cognitive control, and regulation of craving     in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when     compared with those receiving placebo, will have differential brain responses to anticipation     of rewards, during exposure to the Stroop task, and in response to tobacco cues.   "
126924|NCT01623739|"     The investigators are asking subjects to take part in a research study of soft tissue (gums)     and bone (jawbone) healing around dental implants following tooth extraction. The     investigators want to compare how the gums and the bone changes shape with healing in two     different scenarios:        1. When the implant is placed at the same time the tooth is extracted.        2. When the tooth is extracted and then left to heal for a period of 4 to 8 weeks before          the implant is placed.      Previous studies have shown that both methods work and can give good results. In fact the two     methods are used routinely as part of standard care but it is not known if the two procedures     are equally good since they have never been compared in one same research study.   "
127107|NCT01621334|"     This research is a stage 1b developmental trial evaluating an intervention called The Men's     Domestic Abuse Check-Up with adult men abusing their intimate partners and also struggling     with alcohol or drug use.   "
126873|NCT01624415|"     Humans attain binocular vision from the two retinal images of both eyes through a series of     sensory and motor processes that culminate in the perception of stereoscopic depth. Looking     at a scene creates two slightly different images on the retinas which is due to the eyes'     different positions on the head. This so called binocular disparity provides information to     calculate depth and therefore enables stereopsis. Physiologically the two retinal images are     superimposed and merge into one stereoscopic image.      If one image is presented to one eye in an experimental setting, and a completely different     image is presented to the other eye, the investigators visual system, analogous to diplopic     vision, is not able to fuse these image stimuli. Instead, a phenomenon called binocular     rivalry occurs. Here, both images are seen alternating and the brain can switch back and     forth between these images.      The aim of the present study is to investigate the effects of objective changes to image     quality on the investigators subjective stereoscopic perception. This psychophysiological     testing is done by looking at different images and thereafter by subjective grading of the     image quality.      The investigators hypothesize that overlapping image modifications occurring in both eyes are     detected immediately, but changes, that are rotated by 90 degrees against each other, should     be suppressed and result in one stereoscopic image, reduced in image quality. Whether this     also accounts for more detailed images, such as reading cards, is questionable.   "
126874|NCT01624402|"     Older adults who are stroke survivors can experience many challenges, including depression,     cognitive dysfunction, and physical disability. Family members and other caregivers may     struggle with helping stroke survivors adjust to life after stroke. This research study     involves testing a modified form of problem-solving therapy called Ecosystem Focused Therapy     (EFT) to help treat depression in older adult stroke survivors. EFT teaches problem-solving     skills to patients to help them cope with problems related to stroke and depression, alters     their physical environment to accommodate new needs resulting from stroke, and helps the     family or caregiver to assist in the patient's adaptation. In addition this study will     compare EFT to an education intervention to see which is more effective in treating depressed     stroke survivors.   "
126875|NCT01624389|"     Alzheimer's disease (AD) may be one of the most pressing problems facing all countries around     the world as the population ages.AD is a slowly evolving process that likes begins years to     decades before the clinical symptoms area manifest. However, as one would like to identify     the disease process at an earlier point in the clinical continuum, the precision of the     diagnosis is reduced. Therefore, the challenge is to try to identify the process at the     pre-dementia stage and enhance the specificity of the clinical diagnosis through the use of     imaging and other biomarkers. Mild cognitive impairment (MCI) represents an attempt to     characterize subjects at an early clinical phase of AD and subjects with MCI have been a     target for prevention trials. There are two pathological landmarks, in terms of     extra-cellular senile plaques and intracellular neurofibrillary tangles. Although present     symptomatic treatments provide some benefit to patients with AD, they are not the solution     for AD. Up to date, there are still no therapies can alter the underlying nature of the AD     process. Therefore, the earlier the intervention takes place, presumably, the greater the     protection against further neuronal damage will be appreciated.The Alzheimer's Disease     Neuroimaging Initiate (ADNI) is a consortium of universities and medical centers in the     United States and Canada established to develop standardized imaging techniques and     biomarkers procedures in normal subjects, subjects with MCI and subjects with mild AD. ADNI     has been a groundbreaking project, establishing pre-competitive collaboration and real-time     data sharing among academia and industry investigators to clarify the relationships among     demographic, genetic, clinical, cognitive, neuroimaging and biochemical measures throughout     the course of AD neurobiology, in order to facilitate the development of effective     therapeutics.This project has exceeded expectations, providing insights into disease     mechanisms as well as hugely valuable advances, based primarily on the use of standardized     biomarkers, to drug development programs. A number of the leading disease-modifying drug     development programs are now employing ADNI methodology toward more efficient trial design,     particularly in the critically important early (pre-dementia) AD population   "
126876|NCT01624376|"     The primary objective of this study is to investigate the safety and tolerability of locally     administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.      The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period     and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after     the last study visit.   "
126877|NCT01624363|"     The investigators are interested in performing a detailed examination of the pancreas via EUS     (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis     is to make a statistical determination of how many pancreatic cysts the investigators     discover incidentally.   "
126878|NCT01624350|"     This will be a prospective, multi-center, post-market, single arm observational study to     collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of     anorectal fistulas.      The subjects will have baseline and day of surgery visits performed, and then subjects will     return to the investigator for evaluation of defect and safety related morbidities at follow     up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.   "
126879|NCT01624337|"     Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.   "
126880|NCT01624324|"     The aim of this study is to determine whether the plasma concentration of aminoglycoside in     Indonesia neonates with infection are within safe and effective range and its association     with cochlear toxicity and nephrotoxicity.   "
126881|NCT01624311|"     This is a pilot study which will test the safety and feasibility of hypothermia treatment as     adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates     versus conventional treatment (dialysis, nutritional therapy, and ammonia scavenging drugs)     only. The endpoint of the pilot study will be reached when either 24 patients have been     enrolled and no serious adverse events were observed, when no patient has been enrolled in 5     years, or when serious adverse events occur which are clearly linked to the use of     hypothermia. These would be serious complications not seen in patients on conventional     therapy (dialysis , nutritional therapy, ammonia scavenging drugs) for HAE.   "
126882|NCT01624298|"     The purpose of this study is to study the effectiveness of Trauma Focused Cognitive     Behavioral Therapy in subset of children who are affected by trauma with significant mental     health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the     severity of mental health symptoms experienced by traumatized children and adolescents in     Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and     increasing coping strategies and health promotion activities in traumatized children and     adolescents in Lusaka. The study will be integrated into current programing of the Serenity     Harm Reduction Programme, a community and faith based organization focusing on mental health     and substance use prevention and treatment, and its partners in 5 compounds.   "
126884|NCT01624272|"     The global loss of muscle mass and strength associated with aging is a cause of functional     impairment and disability, particularly in the frail elderly. Respiratory function can be     severely compromised if there is a decrease of respiratory (RM) strength complicated by the     presence of comorbidities and physical immobility.      Previous studies have shown that the specific RM training is an effective method to increase     RM strength, both in healthy people and patients. In this case, specific RM training may be     regarded as a beneficial alternative to improve RM function, and thus prevent physical and     clinical deterioration in this population.      The hypothesis is that specific RM training would improve RM strength and endurance in the     experimental groups vs. control who do not participate in RM training.      Institutionalized elderly people with an inability to walk were randomly allocated to a     control group, a Threshold group or a Pranayama group. Both experimental groups performed a     supervised RM training, five days a week for six consecutive weeks. The maximum inspiratory     and expiratory pressures (MIP and MEP) and the maximum voluntary ventilation (MVV) were     assessed at four time points in each of three groups.   "
126885|NCT01624259|"     The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide     compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate     glycemic control on metformin.   "
126886|NCT01624246|"     To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with     augmented renal clearance (ARC).   "
126890|NCT01624194|"     Autism is a pervasive developmental disorder characterized by core deficits in social     behavior and communication, and the presence of repetitive or stereotyped behaviors. It is     one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88     children in the United States. At present, pharmacotherapies target only associated features     of autism, with no effective drug treatments for the social impairments. Several lines of     evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for     the core social deficits in autism. Here we will test the effects of twice daily intranasal     OT (24 IU) over a 4-week period for enhancing social deficits in male and female children     aged 6-12 years with autism. This research has high potential to lead to the development of     more effective treatments and earlier interventions for children with autism.   "
126891|NCT01624181|"     With this study the investigators want to determine, if a fast identification of germs,     causing hospital-acquired infections of the lower respiratory tract, is possible through the     use of MCC-IMS technology - a method that allows on time detection and identification of very     small amounts of substances in gas samples. Therefore aspiration samples from the respiratory     tracts of ventilated patients, which are suspected to develop such an infection, will be     collected, cultivated and analyzed by MCC-IMS. The investigators want to determine if MCC-IMS     diagnostic could be a faster alternative to conventional microbiological methods. The results     of the MCC-IMS analyses therefore will be compared with results of conventional     microbiological methods.   "
126892|NCT01624168|"     The purpose of this study is to determine the feasibility of a 10-week tai chi chuan     intervention as a treatment for anxiety and sleep quality in young adults.   "
126893|NCT01624155|"     Typically, the CTIS Pregnancy Health Information Line in the Department of Pediatrics, School     of Medicine at the University of California educates pregnant women who call the Information     Line after an exposure to a medication that might be harmful to the developing baby has     already taken place, and therefore the opportunity for prevention of that exposure no longer     exists. Frequently these pregnancies are unintended and occur due to the lack of effective     contraceptive use. This study facilitates patient access at UCSD to specialized and     individualized contraceptive counseling for women of reproductive age who are currently     taking a medication that might be risky in a future pregnancy. This study also measures the     impact of individualized contraceptive counseling in changing contraceptive behavior.      Primary Hypothesis: EPIC (EMR)/physician-facilitated referral of female patients of     reproductive age to an existing specialized counseling service at UCSD will improve the     utilization of more effective contraception among women of reproductive age who are     prescribed medications that might be harmful to the developing fetus.   "
126894|NCT01624142|"     A study to assess the long term safety and efficacy of Evolocumab (AMG145)on Low Density     Lipoprotein-Cholesterol (LDL-C) in subjects with severe familial hypercholesterolemia.   "
126895|NCT01624129|"     The purpose of the study is to investigate if serological parameters such as extracellular     Serum-Tryptase (ST) and eosinophilic cationic protein (ECP) are useful for the diagnosis     and surveillance of the eosinophilic esophagitis (EE).   "
126896|NCT01624116|"     Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control     between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting     diabetics is to identify which treatment modality leads to the most stable blood glucose     levels during a fast and how to smooth out these excursions and reduce risks of fast to a     minimum.   "
126897|NCT01624103|"     Results from our preliminary study accepted as e-poster presentation on ESRA (Bordeaux,     September 2012.) showed significant difference in Comfort Score during Ultrasound Guided     Supraclavicular Brachial Plexus block (US-SCB) between young and elderly population. However,     it is unknown whether the difference in Comfort score (1) was associated with reduction of     local anesthetic (LA) volume in elderly or it is attributed to elderly population by itself.     The aim of the study is to compare the Comfort score during US-SCB placement in elderly     patients undergoing upper limb surgery performed with two different volumes of local     anesthetics (20 ml vs 32 ml).   "
126898|NCT01624090|"     Background:      - Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted     against some forms of cancer, but was never accepted as a treatment. Research suggests that     it may be useful against some cancers of the chest, such as lung and esophageal cancer or     mesothelioma. Researchers want to see if mithramycin can be used to treat these types of     cancer.      Objectives:      - To see if mithramycin is safe and effective against different chest cancers.      Eligibility:      - Individuals at least 18 years of age who have lung, esophagus, pleura, or mediastinum     cancers.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies and tumor tissue samples will be used to          monitor the cancer before treatment.        -  Participants will receive mithramycin every day for 7 days, followed by 7 days without          treatment. Each 14-day round of treatment is called a cycle.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Participants will continue to take the drug for as long as the side effects are not          severe and the tumor responds to treatment.   "
126899|NCT01624077|"     The first trial will involve the generation of donor alloantigen-specific CD4+CD25+ Tregs     from peripheral blood of pre-transplant patients, the administration of the CD4+CD25+ Tregs     (1 x 106 cells/kg) at several intervals (for graft specific tolerance induction).   "
126900|NCT01624064|"     Enalapril would significantly reduce progression of renal disease in patients with Chronic     Kidney Disease of Uncertain aetiology.   "
126913|NCT01623882|"     The primary purpose of this study is to evaluate the safety and efficacy of the concurrent     use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous     stasis lower extremity ulcers.   "
126914|NCT01623869|"     This phase II trial studies how well trebananib works in treating patients with advanced     angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor cells     by blocking blood flow to the tumor.   "
126915|NCT01623856|"     This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying     samples of blood and tissue from patients with cancer in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer   "
126901|NCT01624051|"     Cancer patients are highly variable in their body composition, specifically in the proportion     of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body mass) at the     same time. These patients can develop severe muscle wasting, termed sarcopenia. Patients with     sarcopenia have more severe treatment related toxicity requiring delays, dose reductions and     stopping of treatment, and have reduced survival. One potential explanation for this is that     patients with sarcopenia have a reduced volume of lean body mass into which chemotherapy     drugs are distributed, resulting in a higher concentration and greater toxicity. This study     will randomize lung cancer patients to either the standard dosing strategy based on body     surface area or experimental, personalized dosing based on lean body mass. Based on     retrospective findings in this patient population, the investigators expect to find that     severe toxicity will be reduced for sarcopenic patients on the personalized dosing arm based     on lean body mass.   "
126902|NCT01624038|"     The study hypothesis that treatment with Erythropoietin (EPO) combined with Human     Erythropoietin (HUO) therapy will result in hematologic improvement in thalassemia intermedia     patients.      Second is to determine whether any of the following correlate with improved hematologic     response:      A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline     levels,baseline Erythropoietin levels,baseline hemoglobin levels and baseline reticulocyte     counts (or % circulating nucleated erythroblasts/100 WBCs).      Goal:      The aim is to assess the possibility of steady increase of hemoglobin levels in thalassemia     intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea     and Erythropoietin, growth evaluation,quality of life (QoL) and decline transfusion     requirements during study period. Also to report and compare adverse events with other     published data regarding.   "
126903|NCT01624025|"     A salvage treatment with combination of docetaxel and epirubicin in patients with     unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based     study   "
126904|NCT01624012|"     The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is     better in noninvasive ventilation of premature infants than currently used Nasal Continuous     Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.      The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more     synchronous with patient, which will lead to a decrease in need of inspired oxygen.   "
126905|NCT01623986|"     The purpose of this clinical study is to investigate if central venous pressure (CVP)     measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP)     when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.   "
126906|NCT01623973|"     To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could     interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the     impact on daily function, quality of life. In this pilot, randomized, blind and allocation     concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned,     after the first evaluation, into two groups: group without restriction (G1), subject only to     the specific training of paretic UL, and restricted group (G2), which underwent specific     training of paretic UL and use of the restriction of non paretic UL   "
126907|NCT01623960|"     The primary aim of this study is to evaluate the overall quality of life in adult patients     with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and     to assess the impact of certain disease and drug related factors (treatment modality,     presence of viral disease, inhibitor, etc.) on the quality of life.   "
126908|NCT01623947|"     Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve     cycling performance and mental acuity in a dose-dependent response.   "
126909|NCT01623934|"     This study includes 2 phases. During phase 1, pregnant women are followed over the course of     pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3 and 5 year after     delivery.      The purpose of this phase 1 is to :        -  assess the contribution and interactions of adipokines in the development of insulin          resistance during pregnancy and gestational diabetes;        -  assess levels of maternal adipokines as determinants of development and fetal growth;        -  determine the genetic variations that influence levels of adipokines and glucose          regulation during pregnancy and in newborns.      The purpose of this phase 2 is to:        -  identify DNA methylation variations at birth that are predictive of childhood          overweight/obesity.        -  identify maternal characteristics associated with DNA methylation variations predictive          of childhood overweight/obesity.        -  establish whether the loci predictive of childhood overweight/obesity at birth are still          differentially methylated at 5 years of age (samples collected at 5 years of age).        -  identify DNA methylation variations at birth that are predictive of childhood          neurodevelopment problems at 3 and 5 years of age.   "
126910|NCT01623921|"     Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading     cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently     suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2) is a key     enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2 plays an     important role in the pathogenesis of acute lung injury (ALI).      Aims: The current study aims at evaluating the beneficial effects of statins and COX-2     receptor inhibitors on ALI elicited by blunt trauma to the chest.      Methods: After approval by the institutional ethics and a scientific committee, and obtaining     informed consent , patients admitted to the emergency department (ED) due to blunt trauma     with a diagnosis of lung contusion will be enrolled in the study.The effects of statins and     COX 2 inhibitors on ALI will be assessed by recording clinical parameters and measuring     inflammatory mediators levels in the serum and in the bronchoalveolar space.      Expected results: The investigators expect to find that the proposed treatment will be     effective in reducing ALI burden. The investigators also suppose that using a combination of     those drugs will synergistically potentiate their effect on ALI.   "
126911|NCT01623908|"     The main purpose of this study is to observe and assess the impact of adjuvant zoledronate on     bone density in breast cancer patients.      The second purposes:        -  The efficacy of adjuvant zoledronate        -  The safety of adjuvant zoledronate        -  The bone loss of breast cancer patients in Guangdong        -  The correlation between bone loss of breast cancer patients and treatment of disease in          Guangdong   "
126916|NCT01623843|"     The purpose of this study is to determine whether surgical correction of hip impingement     morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved     clinical results (decreased pain and improved function) in adult patients with     femoroacetabular impingement (FAI) compared to arthroscopic lavage (washing out of painful     inflammation debris) and treating obvious damage of the hip joint.   "
126917|NCT01623830|"     The overall aim of this project is to determine if using a cue to trigger (and reactivate)     the fear memory 10 minutes prior to exposure treatment sessions leads to less anxiety in     patients with a fear of flying. The long term goals are to establish if targeting the     reconsolidation of fear with a reminder of the fear is effective for human clinical     populations in reducing relapse (return of fear). In this investigation, the investigators     propose to treat 64 patients diagnosed with a fear of flying (FOF) using virtual reality     exposure therapy (VRE). All patients in the study will receive exactly the same exposure     treatment using a virtual airplane.   "
126918|NCT01623817|"     The goal of tish clinical research study is to identify that loading of vancomycin can     faciliate rapid attainment of target trough serum vancomycin concentration.   "
126919|NCT01623804|"     The purpose of this pilot study is to determine the feasibility of conducting a high quality     clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee     osteoarthritis pain and physical function.   "
126920|NCT01623791|"     The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria,     random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300     mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe     preeclampsia. The cross-sectional longitudinal study design used, 209 patients with     pre-diagnosed preeclampsia in which in our inpatients clinic included this study. Random     urine samples were taken before the 24 hour urine collection for spot urine analysis for     evaluated proteinuria and protein/creatinin ratio. 24 hour urine analysis was performed in     all patients as the gold standard of the urine total proteinuria.   "
126921|NCT01623778|"     Along with the improvement of the accuracy of detection of HBV serological markers, the     optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection     becomes feasible. Currently, the recommendation of optimized treatment especially interferon     therapy are mainly based on retrospective studies, it still lacks prospective evidence. This     study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks     optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg     positive CHB with inadequate response to 24 weeks interferon treatment.   "
126922|NCT01623765|"     To collect data of all patients who have undergone Endobronchial ultrasound for diagnosis or     staging of suspected lung cancer   "
126923|NCT01623752|"     It is known from the COMET-trial that patients who start Enbrel treatment early have a great     chance of reaching clinical remission and radiographic nonprogression. It is still unclear,     however, how many patients with early arthritis achieve remission and radiographic     nonprogression under the conditions of routine rheumatologic care and the local     recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX).      Therefore, no robust x-ray data are available to show/demonstrate        -  the average extent of x-ray damage in routine patients on Enbrel outside clinical          studies.        -  if the outstanding effect on structural damage of Enbrel can be reproduced in routine          practice.        -  that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also          for day-to-day decision making.        -  the optimal onset of Enbrel treatment in the course of the disease to prevent          radiographic damage   "
127071|NCT01621802|"     The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®)     in the US by generating immunogenicity and safety data in contrast to the US standard of     care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six     years of age.   "
126925|NCT01623726|"     The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as     complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized     into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will     be measured by specific clinical rating scales based on the assessment of negative symptoms.     A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes     shall include collateral effects evaluation, anxiety and depressive scales as well as     clinical monitoring.   "
126926|NCT01623713|"     The purpose of this study is to determine whether iloperidone is effective in the treatment     of Schizophrenia.   "
126927|NCT01623700|"     This observational study will based on the Register of Information and Knowledge About     Swedish Heart Intensive Care Admissions (RIKS-HIA) and the Swedish Coronary Angiography and     Angioplasty Registry (SCAAR) which since 2009 are merged into The Swedish Web-system for     Enhancement and Development of Evidence-based care in Heart disease Evaluated According to     Recommended Therapies (SWEDEHEART).      The aim of this study is to investigate the impact of different antithrombotic treatment     options (treatment duration, type of treatment and combination of treatments) in Acute     Coronary Syndrome (ACS) patients on outcomes such as recurrent ischemic events and mortality.   "
126928|NCT01623687|"     What is the intensity of F-PET uptake in healthy and osteo arthritic femur and acetabulum,     compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months     after surgery?   "
126929|NCT01623674|"     The aim of the study was to asses the effect of sleep deprivation during nightshift by     monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. The first     day was pre call= day 1, second day was on call= day 2, third day was the first post call day     = day 3 and fourth day was the second post call= day 4. The surgeons were monitored in order     to asses how performance was on call compared to pre call and post call. The hypothesis was     that they would perform worse on call than pre call, and again slightly worse post call.   "
126930|NCT01623661|"     Patients with chronic kidney disease (CKD) have a defect in the tubular reabsorption of     sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy     subjects.      Urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be     measured after an infusion with hypertonic saline in CKD patients and healthy subjects.   "
126932|NCT01623635|"     Pain following laparoscopic surgery continues to be a clinically important problem with 80%     or more patients requiring opioid analgesia post-operatively to control their pain. By     reducing this surgical complication patients can experience less discomfort and be discharged     from the recovery room more rapidly leading to reduced resource utilization and expense.      HYPOTHESIS: Post-operative pain after laparoscopic procedures could be treated by topical     anesthetics sprayed directly into the abdomen (inside the abdominal cavity, on the nerve     endings of the visceral peritoneal lining and diaphragm surface) via the surgical incision     METHODS: Randomized controlled trial on use of topical anesthetic (namely 0.25% ropivacaine)     delivered directly onto the target sites both at the beginning and the end of surgery in     patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign     pathology. The drug will be delivered using a CE approved delivery system that will direct a     fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the     cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).      GOAL: to assess the efficacy of intraperitoneal topical anesthesia in reducing postoperative     pain, opioid requirements in patients undergoing laparoscopic gynecologic procedure for     uterine or adnexal benign pathology   "
126933|NCT01623622|"     The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with     severe upper limb hemiplegia following stroke.   "
126934|NCT01623609|"     The purpose of this study is to demonstrate the Bioequivalence, assess food administration on     the Pharmacokinetics with naloxegol.   "
126935|NCT01623596|"     A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to     fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have     only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) .     Patients will be able to switch to different treatment for safety, efficacy, tolerability or     convenience during the study.      Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on     treatment. Secondary objectives are to compare reasons for discontinuation, adverse events,     cognitive impairment, medication satisfaction and change in brain volume measured by MRI.   "
126936|NCT01623583|"     An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a     superior option for delivery of dialysis, but requires needles to be inserted. Patients on     dialysis who indicate fear of needles as the reason for not switching from a long-term     central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the     eligibility criterial will be asked to participate. Patients will receive either a standard     or an enhanced intervention to address their fear of needles. The enhanced intervention     includes the standard intervention plus video training about Synera and trying out an actual     patch. Over the 4 months following the intervention, how many patients sign up to switch     access will be tracked.   "
126937|NCT01623570|"     The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio     with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH     women.      This open-label monocentric, randomized comparative trial, to receive the two different     standard clinical practice treatments:        -  1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH)        -  2 vials of Menopur: (vials/powder hMG 75IU).      Follicular development were monitored until the protocol hCG requirement is met and a single     injection of hCG was administered.      Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm),     pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25     nanomole/Liter (nmol/L).   "
127072|NCT01621789|"     Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during     cataract phacoemulsification.   "
126938|NCT01623557|"     This study aims to assess the safety and effectiveness of four new candidate malaria     vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS & MVA ME-TRAP. These vaccines consist of viruses     (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans     and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP).     The hope is that these vaccines will induce immune responses in vaccinees that are able to     prevent malaria.      This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria     infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and     Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in     Southampton, UK. The malaria challenge will take place at the insectary at Imperial College     (Infection and Immunity Section) in London, UK.   "
126939|NCT01623544|"     The objective of this study is to compare the real-world effectiveness of BFC and FSC in     asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan     enrollees.   "
126940|NCT01623531|"     The aim of the study is to show that first line treatment with concentrated fibrinogen has     superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and     cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.   "
126941|NCT01623518|"     This is a first in man dose escalation study, to assess the safety and immunogenicity of the     candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults     aged 18-50. Volunteers will be enrolled and doses will be escalated according to a 3+3     study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine,     volunteers will be followed up to assess the side effect profile of the vaccine and to take     blood tests. A series of immunology assays will be performed to determine how potent the     vaccine is at inducing an immune response.   "
126957|NCT01623310|"     This is an open-label, multicenter study designed to assess the safety of intranasal     administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose     device in subjects with chronic sinusitis with or without nasal polyps. The study consists of     an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The     duration of each subject's participation is approximately 53 weeks.   "
126958|NCT01623297|"     A study will be conducted to determine if there is any cognitive benefit in elderly patients     having open versus minimally invasive colon cancer surgery.   "
127760|NCT01612780|"     The purpose of this study is to show clinically meaningful improvement in symptom severity     after trans-nasal balloon dilation of the maxillary sinus outflow tract with or without     balloon dilation of the frontal or sphenoid sinuses.   "
126942|NCT01623505|"     Research Aims      The aims of this research study are:        1. To determine which of the following three smoking cessation medications is most          effective in achieving cessation:             -  Nicotine Patch             -  Nicotine Patch + gum or inhaler             -  Varenicline (Champix;        2. To investigate how often participants experience neuropsychiatric symptoms over the          course of their cessation attempt and to assess whether:             -  They occur more often when taking one medication versus another             -  They occur more often in those with or without psychiatric illnesses.      Hypotheses to be Tested      The hypotheses to be tested include the following:        1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target          quit date will be significantly higher in smokers receiving long-term transdermal NRT in          combination with other NRT products or those receiving varenicline compared to those          receiving transdermal NRT alone.        2. Some participants will experience neuropsychiatric symptoms during their cessation          attempt, and those in the varenicline group will experience a greater incidence of          neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in          combination with other NRT products. Patients with psychiatric illnesses will report          higher levels of withdrawal symptoms than those without psychiatric illnesses.   "
126943|NCT01623492|"     Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational,     US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet     enrollment. Patient data will be collected prospectively for three years. Individual     physician feedback will be provided on data collected with the purpose of improving the     management of patients - quality enhancement research initiative (QuERI) process.   "
126944|NCT01623479|"     This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at     least 12 months for hypotrichosis of the eyelashes.   "
126945|NCT01623466|"     Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will     be evaluated.   "
126946|NCT01623453|"     This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of     ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical     trial.   "
126947|NCT01623440|"     This study aims to characterize the neurobiology of obesity in American Indians (AI) using     functional MRIs to examine the correlation between brain response to food stimuli in AI     women. A functional MRI (fMRI) is used to visualize brain activity when obese and lean AI     women look at images of fattening food, non-fattening food and non-food objects. Additionally     examined is the effect of the drug naltrexone to suppress brain response to visual food cues     and calorie intake in the women.   "
126948|NCT01623427|"     Postoperative pain and time taken to return to normal activities after laparoscopic surgery     are significantly shorter. Wound infections still occur and contribute to prolonged hospital     stays and morbidity. Typically, port incision sites are covered with a standard dressing     (approximating strips and a gauze). Although the umbilical wound infection rate in     laparoscopic surgery is considered to be low, a recent study by Muensterer and Keijzer showed     that the umbilical wound infection rate after single incision laparoscopic appendectomy in     children is approximately 7%. In the same retrospective study, the investigators demonstrated     that a simple low cost vacuum dressing can significantly reduce the infection rate. The aim     of this prospective randomized controlled trial is to determine if the simple vacuum dressing     is superior to a standard dressing in reducing laparoscopic postoperative umbilical wound     infections. All patients under 17 years of age undergoing a laparoscopic operation in the     Children's Hospital will be randomized to a standard postoperative dressing or a standard     postoperative dressing with vacuum applied to it. The vacuum will be applied with a 22g     needle on a 10ml syringe passed percutaneously from outside the dressing into the gauze and     the air around the gauze is evacuated. The umbilical wounds will be evaluated 8-10 days     postoperatively in the clinical research unit of the Manitoba Institute of Child Heath     according to a standardized and validated wound evaluation tool from the Canadian Center for     Disease Control. Primary outcome measure in this study is postoperative wound infection. A     sample size calculation using the retrospective data demonstrated that the investigators need     275 patients in each group for the Chi-squared test to have an 80% chance of detecting a     difference in wound infection rate of 6% at the 5% level of significance. Based on the annual     number of laparoscopic operations in the Children's Hospital (around 400) the investigators     anticipate completing the inclusion of patients within a two-year period.   "
126949|NCT01623414|"     The purpose of this study is to examine the amount of sunlight exposure and vitamin D status     of adolescent schoolchildren of South Asian ethnicity in each season throughout the year.   "
126950|NCT01623401|"     This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701     FA once daily for 10 days and will include ophthalmologic and neurologic assessments.   "
126951|NCT01623388|"     This research is being done to find out if significant changes in blood glucose cause bad     outcomes in patients with diabetes.   "
126952|NCT01623375|"     This trial is conducted in Europe. The aim of the trial is to investigate the absolute     bioavailability of insulin degludec (IDeg) in healthy subjects.   "
126954|NCT01623349|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational combination of drugs. Phase I studies also try to define the appropriate     dose of the investigational combination to use for further studies. Investigational means     that the combination of these drugs is still being studied and that research doctors are     trying to find out more about it. It also means that the FDA has not approved either of these     drugs nor the combination of being tested for use in patients, including people with your     type of cancer.      BKM120, BYL719 and olaparib are drugs that may stop cancer cells from growing abnormally.     These drugs when combined in laboratory experiments with animals, have demonstrated     anti-cancer activity. Information from these other research studies suggests that the     following agents BKM120, BYL719 and olaparib, may help to shrink tumor cells in the types of     cancers being studied in this research study.      In this research study, the investigators are looking for the highest dose that can be given     safely and also to see if the combination of BKM120 or BYL719 and olaparib is effective in     treating your type of cancer.   "
126955|NCT01623336|"     The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon     alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in     naive patients with chronic hepatitis C.   "
126956|NCT01623323|"     This is an open-label, multicenter study designed to assess the safety of intranasal     administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose     device in subjects with chronic sinusitis with or without nasal polyps. The study consists of     an up-to-7-day pretreatment phase followed a 3-month open-label treatment phase. The duration     of each subject's participation is approximately 13 weeks.   "
127761|NCT01612767|"     The purpose of this study is to demonstrate the safety and efficacy of the investigational     BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native     coronary arteries.   "
126959|NCT01623284|"     The study is designed to determine whether there are clinical features that can be used as     biomarkers to predict whether underlying Alzheimer's pathology is the cause of a speech and     language based dementia. The primary hypothesis is that the proportion of patients who test     positive for beta-amyloid deposition will vary across different speech and language based     dementias.   "
126960|NCT01623271|"     The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with     certain types of neuropathic pain without causing too many side effects.   "
126961|NCT01623258|"     The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node     metastasis with sentinel lymph node (SLN) mapping.      Null hypothesis: There is no difference in the rate of lymph node metastasis between     conventional histopathological processing of lymph nodes and SLN mapping with detailed     pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of     colon carcinoma.   "
126962|NCT01623245|"     Cardiac amyloidosis are related to the accumulation of fibrillar proteins in the     extracellular leading to disruption of the cardiac tissue architecture. Amyloidosis in     transthyretin (TTR) are the most common hereditary amyloidosis but remain poorly studied at     heart. This is serious and deadly. The prevalence of TTR amyloidosis is probably     underestimated in hypertrophic cardiomyopathy (HCM) often of unknown etiology because of the     lack of systematic implementation of myocardial biopsy because of their side effects.   "
126963|NCT01623232|"     This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants     aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion     adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three     reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed,     unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral     strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be     assessed.   "
126964|NCT01623219|"     The investigator proposes to examine treatment for Posttraumatic Stress Disorder for Veterans     who served in Iraq and Afghanistan provided through telemedicine which connects patients to     doctors in different locations using the internet. In this study, Veterans will receive     prolonged exposure therapy (PE). This treatment has been shown to be effective in reducing     PTSD symptoms. For this study 9 weekly 90 minute sessions will be given over a period of up     to 3 months. The first 2 sessions of each treatment will involve education, rational and     treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud     and repeatedly. The purpose of this study is to determine if this treatment is effective when     given through telehealth. To this end, the investigators propose to enroll up to 20     individuals who will access the investigators services through the GA telehealth network who     has hundreds of telehealth sites across the state of Georgia. Patients will go to these sites     to access the investigators therapists using GA telehealth equipment. The investigators     hypothesize that PE delivered remotely through telemedicine will work to reduce the symptoms     of PTSD.   "
126965|NCT01623206|"     The objective of this study is to find the maximum tolerated dose and preliminary efficacy of     desmopressin as an haemostatic agent, when is administered to patients with colorectal cancer     and rectal bleeding, before specific oncologic treatment with surgery and/or chemotherapy     and/or radiotherapy.   "
126966|NCT01623193|"     This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia     to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that     all-blood cardioplegia will be associated with less blood transfusion and better cardiac     function.   "
126967|NCT01623180|"     The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is     non-inferior to a bare metal stent at one year as measured by the composite safety endpoint     of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and     that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at     one year.   "
127073|NCT01621776|"     This study aims to compare the post-meal blood glucose values of two drugs in a real-world‟     setting.   "
126968|NCT01623167|"     Background:        -  Severe aplastic anemia is a rare and serious blood disorder. It happens when the immune          system starts to attack the bone marrow cells. This causes the bone marrow to stop          making red blood cells, platelets, and white blood cells. Standard treatment for this          disease is horse-ATG and cyclosporine, which suppress the immune system and stop it from          attacking the bone marrow. However, this treatment does not work in all people. Some          people still have poor blood cell counts even after treatment.        -  Eltrombopag is a drug designed to mimic a protein in the body called thrombopoietin. It          helps the body to make more platelets. It may also cause the body to make more red and          white blood cells. Studies have shown that eltrombopag may be useful when added to          standard treatment for severe aplastic anemia. It may help improve poor blood cell          counts.      Objectives:      - To test the safety and effectiveness of adding eltrombopag to standard immunosuppressive     therapy for severe aplastic anemia.      Eligibility:      - Individuals at least 2 years of age who have severe aplastic anemia that has not yet been     treated.      Design:        -  Participants will be screened with a physical exam, medical history, and blood tests.          Blood and urine samples will be collected.        -  Participants will start treatment with horse-ATG and cyclosporine. Treatment will be          given according to the standard of care for the disease.        -  Cohort 1: After 14 days, participants will start taking eltrombopag. They will take          eltrombopag for up to 6 months.        -  Cohort 2: After 14 days, participants will start taking eltrombopag. They will take          eltrombopag for up to 3 months.        -  Cohort 3 and Extension Cohort: Participants will start taking eltrombopag on Day 1. They          will take eltrombopag for up to 6 months.        -  Participants may receive other medications to prevent infections during treatment.        -  Treatment will be monitored with frequent blood tests. Participants will also fill out          questionnaires about their symptoms and their quality of life.   "
126969|NCT01623154|"     The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring     13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath     test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in     pediatric subjects.   "
126970|NCT01623141|"     The aim of the study is to investigate the correlation between increased bone metabolism in     the 3 phase bone scintigraphy (TPBS) and decreased pressure pain thresholds in patients with     complex regional pain syndrome (CRPS) of the upper limb and a non-CRPS-group. The     investigators assume that there will be a significant correlation between the investigated     values in the CRPS-group whereas the non-CRPS-group shows no significant correlation.   "
126971|NCT01623128|"     A randomized, controlled trial will be conducted during which pregnant women will be     randomized to receive the intervention - viewing a prenatal education video about how to     breastfeed an infant - or the sham intervention - viewing a prenatal education video about     maternal nutrition and physical activity during pregnancy. Participants will be interviewed     via telephone at one, three, and six months post-partum to determine how they feed their     infants at each of these time frames.   "
126972|NCT01623115|"     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9     (proprotein convertase subtilisin/kexin type 9).      Primary Objective of the study:      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels     after 24 weeks of treatment in comparison with placebo.      Secondary Objectives:        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time          points        -  To evaluate the effects of alirocumab on other lipid parameters        -  To evaluate the safety and tolerability of alirocumab   "
126973|NCT01623102|"     Advanced non-small-cell lung cancer (NSCLC) patients without epidermal growth factor receptor     (EGFR) mutations show a poor prognosis. Gemcitabine combined with cisplatin chemotherapy is     an effective treatment measures for EGFR mutation-negative NSCLC patients, but the prognosis     remains poor. Chemotherapy combined with targeted monoclonal antibody treatment may be better     treatment options in these patients. Monoclonal antibodies, such as bevacizumab, can block     tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood     vessels and spread. It is not yet known whether cisplatin and gemcitabine is more effective     when given alone or with bevacizumab. This randomized trial studies how well giving cisplatin     and gemcitabine alone or in combination with Bevacizumab (Avastin) works in treating patients     with stage IIIB/IV non-squamous NSCLC without EGFR mutations.   "
126974|NCT01623089|"     Asthma is a heterogenous disease. Different patients have different presentations, course of     disease and response to treatment.      The investigators would like to study our population of more severe asthma and find out about     their profile - demographic, clinical and inflammatory.   "
126975|NCT01623076|"     This study seeks to determine the biologic causes of inflammation in patients with Transverse     Myelitis (TM) Neuromyelitis Optica Spectrum Disorder (NMOSD) and related conditions. While     patients will be treated according to decisions with their treating physician, this study     will collect data and samples from patients prospectively to gain a better understanding of     the disease. We are seeking to understand why some patients respond to medications, while     others do not. We also seek to understand what happens biologically, preceding relapses.     Gathering these data and samples will allow researchers to identify new ways of diagnosing     and treating these diseases. Data and samples will be shared with researchers around the     world to support collaborative efforts to treat these conditions.   "
126976|NCT01623063|"     To detect similarities and differences in the endometrium of fertile and infertile patients   "
126977|NCT01623050|"     The purpose of this study is to assess safety and performance of the SinuSys Dilation System     for dilation of the maxillary sinus ostium.   "
126978|NCT01623037|"     The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for     non-invasive fat layer reduction in flanks for Asian patient population.   "
126979|NCT01623024|"     Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of disorders characterized by     predominantly macrovesicular hepatic steatosis occurring in individuals in the absence of     significant alcohol consumption. In this context it is possible to distinguish a condition of     simple fatty liver, where the only histologic finding is the presence of steatosis, from a     state of non-alcoholic steatohepatitis (NASH), characterized by hepatocellular     injury/inflammation with or without fibrosis. The prevalence of NAFLD is around 20-30% in the     general population. With a rapid increase in the risk factors for metabolic syndrome, NAFLD     has become the most common cause of liver disease in Western countries. The clinical     relevance of NAFLD arises from the fact that a considerable proportion of subjects (20-30%)     develop NASH, and this condition can progress to cirrhosis in up to 15% of patients. In     addition NAFLD, and particularly NASH, represents a cardiovascular risk factor, independent     of other well-known conditions contributing to heart and vascular diseases.      Lifestyle modification is the effective medical treatment recommended for NASH, while there     is currently no pharmacologic therapy of proven benefit in these patients. Several pilot     studies, using insulin sensitizers (thiazolidinediones or metformin), and antioxidants, like     vitamin E, have provided inconclusive evidence that these drugs may improve clinical and     histological features of NASH.      In the complex and not completely understood pathogenic puzzle of NAFLD and NASH, also     vitamin D might have an important role. Vitamin D deficiency is associated with many common     pathological conditions frequently observed in NAFLD, like cardiovascular disease, and     insulin resistance. A recent paper by Targher and colleagues showed low vitamin D serum     levels in NAFLD patients, identifying an inverse relation between vitamin D levels and the     severity of liver disease. In keeping with the above data, recent experimental evidence also     suggested the potential ability of vitamin D, through interaction with its nuclear receptor     (vitamin D receptor - VDR), to interfere with inflammatory response, T cell function and     fibrogenesis. Therefore considering the link between vitamin D serum levels, severity of     NAFLD, and risk factors for NAFLD, we speculate that vitamin D might represent a new     therapeutic target in the management of NASH patients.   "
126980|NCT01623011|"     Shoulder problems causing pain and decreased function are very common. Many of these problems     are related to the rotator cuff tendons. Shoulder arthroscopy surgery (keyhole surgery) is a     common treatment for this pain. This can involve an Arthroscopic Subacromial Decompression     (ASAD) an operation used to remove bony spurs which may be the cause of the pain. This     procedure is widely used despite limited evidence of any effectiveness. This is a randomised     controlled trial that will compare ASAD against an investigational shoulder arthroscopy     (without spur removal/decompression) to indicate whether spur removal is really necessary and     in turn, assessing the effectiveness of the ASAD procedure. Both surgical interventions are     routine and will mirror each other except for the spur removal element. Both treatments will     be compared against a control (non operative management with specialist reassessment) group     to indicate whether surgery in general is effective for patients with subacromial pain.     Patients randomised to either of the surgical options will be blinded to the type of surgery     they have. This is a multicentre trial taking place in 10 centres in England and Wales. Two     satellite studies will also take place. One will involve a subset of patients undergoing MRI     scans to examine the effects of their shoulder pain on their brain transmissions. The other     will involve collecting tissue samples from patients undergoing surgery.   "
126981|NCT01622998|"     The primary aim of this research study is to determine whether titrated, patient-directed     transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves     long-term rates of smoking cessation in patients motivated to quit smoking when compared to     patients using the standard transdermal NRT patch protocol. The following hypothesis will be     tested: CO-validated continuous abstinence rate at 52 weeks post target quit date will be     higher for the titrated, self-directed NRT group compared to the standard NRT treatment     group.   "
127025|NCT01622400|"     A dedicated therapeutic education program is an essential tool in the management of     hypertension as well as in the control of other cardiovascular risk factors. The purpose of     this study is therefore to evaluate the effect of such a therapeutic education program in     general practice patients at high cardiovascular risk.   "
126982|NCT01622972|"     The University of Nottingham have been developing new, non-invasive magnetic resonance     imaging (MRI) techniques to image the bowel. Building on those studies the investigators want     to study, in healthy volunteers, the effects of purging on the colon. The investigators plan     two studies using their novel MRI techniques in healthy volunteers to demonstrate how doses     of a preparation designed to clean the bowel alters small and large bowel water content and     transit. The investigators will also define the changes induced in colonic microbiota and how     these are linked to changes in transit and the structure of colonic contents. This     experimental model is comparable to an episode of acute diarrhea, therefore this study will     also improve their understanding of the effects of diarrhea on bowel physiology.      Following from the above study, the investigators would like to extend this study on patients     who have functional constipation and previously have not responded to conventional laxatives.   "
126983|NCT01622959|"     Pain is the most common reason that patients present to an emergency department (ED) and is     often inadequately managed. Evidence suggests that acupuncture is effective for pain relief,     yet it is rarely practiced in the ED.      In 1998, a United States National Institute of Health Consensus Conference Panel reviewed the     status of acupuncture and concluded that: There is sufficient evidence of acupuncture's     value to expand its use into conventional medicine and to encourage further studies of its     physiology and clinical value. Similarly, in 2002, the World Health Organisation (WHO)     stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness     as analgesia has been established in controlled clinical studies.      Notwithstanding these difficulties, it has been shown that acupuncture analgesia in the     treatment of chronic pain is comparable to morphine and that its better safety profile and     lack of dependence makes it the preferred method of choice for these conditions.      There are very few clinical trials of acupuncture for acute pain to inform clinical practice;     that's why we have the idea to do this study in our emergency department.   "
126984|NCT01622946|"     The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the     suction drain following a total hip replacement   "
126986|NCT01622920|"     The investigators have now established a technique to measure enamel thickness which has been     shown to work well in-vitro. The teeth tested so far, obtained from the Dental School Tissue     Bank, have been molars or pre-molars. In these cases, the measurement is made more difficult     by the curvature of the tooth surface and it seems likely that flatter larger, incisors would     give more satisfactory results. The investigators therefore wish to establish in-vivo whether     this hypothesis is correct.   "
126987|NCT01622907|"     Prospective, multi-center, investigator-driven trial. This study hypothesizes that combining     surgical endoscopic and transcatheter techniques in a staged fashion provides superior     clinical outcomes than isolated surgical/EP approaches in patients with persistent AF lasting     > 1 year but > 5 years.      The proposed procedure involves the creation of cardiac lesions with epicardially applied     radiofrequency (RF) ablation through a minimally invasive surgical (MIS) approach followed by     a delayed EP ablation procedure performed at 1-2 months from the surgical operation.   "
126988|NCT01622894|"     Genetics of mendelian forms of young onset Alzheimer Disease (GMAJ project)      Introduction : Autosomal dominant forms of Alzheimer disease (AD) are characterized by young     age of onset. In France the prevalence was estimated at around 1000 cases. The Phenotypical     Expression: There is diversity in phenotypical expression, associating dementia, spastic     paraplegia, early extrapyramidal syndrome, ataxia or stroke caused by severe cerebral amyloid     angiopathy. Diversity in neuropathological expression is demonstrated by the presence of     cotton wool plaques, Lewy bodies with Lewy neurites and severe cerebral amyloid angiopathy.      The study of mendelian forms is decisive in the physiopathological comprehension of AD and     related diseases, since the alteration of those genes involved is sufficient to cause the     disease. In AD, identification of these genetic causes allows the formulation of the amyloid     hypothesis, which is the basis of current therapeutic developments concerning the Ab peptide.     Currently three genes (APP, PSEN1, PSEN2) are identified in early onset mendelian forms and     their mutations are involved in 80% of the 139 French families, studied since 1993 within the     framework of U614 and the National Reference Centre for Alzheimer Disease in young subjects     (CNR-MAJ).These results are arguments in favor of the GMAJ project and have two main     objectives:      (i) to identify new genes in mendelian AD forms without detectable alteration on known genes.      (ii) to correlate phenotypes and genotypes within families associated with known mutations     and extend the description of the phenotypical spectrum.      Population: Families eligible for this study are those with at least 2 individuals with AD     criteria (clinical or neuropathological) with onset before 65 years of age. Duration of     inclusion is 3 years. This multicentre study groups 23 clinical centres. The inclusion number     is 50 new families per year.      Method: Extension and description of families with unknown genetic causes, inclusion of novel     families with autosomal dominant AD. The successive steps of the project are the following:      (i) Thorough phenotypical characterization in order to document family history and     characterize the probands and affected related subjects according to standardized protocol     for clinical, neuropsychological, biological (biomarker determination in plasma and     cerebrospinal fluid) and imaging data (MRI, TEMP).      (ii) Identify known genetic causes (PSEN1/2, APP) with novel autosomal dominant families.      (iii) Extend analysis of the pedigrees of families with unknown genetic causes.      (iv) Identify novel genetic causes within these families which are negative for known     mutations.      This study uses 3 methods:        -  pangenomic search is performed for microalterations (Copy Number Variants or CNV) by          Comparative Genomic Hybridization (CGH) with high resolution (10 kb on average).        -  potential targets are then validated by the study of large control populations,          intrafamilial cosegregation and functional validation.        -  the remaining families at the end of this stage will be characterized by means of high          throughput sequencing of all exonic areas.           (v) Follow up study of patients and siblings with 2 goals:        -  evaluation of the disease course and consequences (individual, familial and social);        -  occurrence of novel AD cases within the family.      (vi) Neuropathological description with potential novel description of atypical AD cases.      Results and consequences: Identification of novel genetic causes of AD are of importance in     completing the mechanisms of the amyloidergic hypothesis. This project is useful to promote     the guidelines on the genetic diagnosis of AD in France.   "
126989|NCT01622881|"     The investigators examined the efficacy of nefopam in patients undergoing kidney     transplantation.   "
127008|NCT01622621|"     This randomized phase II trial is for medically inoperable early stage non-small cell lung     cancer (NSCLC) patients. It is designed to compare the number of patients who are disease     free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical     intervention arms. SBRT is less invasive and felt to be equally effective to surgery for     early stage NSCLC. Surgery is currently the standard of care for these patients. The     hypothesis of this study is that SBRT is at least as good as surgery for disease free     survival at 2 years.   "
126990|NCT01622868|"     This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic     radiosurgery with or without lapatinib ditosylate works in treating patients with breast     cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2)     on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill     tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy     that delivers a single, high dose of radiation directly to the tumor and may kill more tumor     cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known     whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib     ditosylate is an effective treatment for brain metastasis from breast cancer.   "
126991|NCT01622855|"     The purpose of this study was to evaluate whether a brief intervention in video format     delivered in the post assault medical exam setting and including education about assault     reactions and instruction in and modeling of successful coping strategies would reduce post     assault drug use or abuse and PTSD symptoms as compared to standard care.   "
126992|NCT01622842|"     The overall objectives were to investigate if characteristic dimensions for tissue and     vessels determined from measured bioimpedance spectra would provide the same values as     dimensions determined from MR images of the upper arm and verify that temporal variations of     impedances could be converted to blood pressure.   "
126993|NCT01622829|"     This study tries to improve patient's activity by a Prescription for Activity led by     physiotherapists in secondary health care setting.      Three groups are compared in regard to their increase of physical activity.   "
126994|NCT01622816|"     Comparing visual acuity measurements (measurements of how well you can see) using a standard     ETDRS (Early Treatment Diabetic Retinopathy Study) chart and a handheld ETDRS chart   "
126995|NCT01622803|"     Internal biliary drainage using stent is used for malignant hilar obstruction such as     cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.      Bilateral drainage is more physiologic and have more long patency than unilateral drainage.      There are two methods of bilateral drainage: Y-stent and side by side.      However there are no clinical data about comparing the effectiveness of these two methods.      Therefore the investigators want to compare the clinical outcomes of two methods:      Y-stent and side by side.   "
127926|NCT01610622|"     Presently there is no apparatus, clinically available, for routine determination of cardiac     output (CO) in children. The goal of this research is to develop new technology that will     help determine CO in neonates.   "
126996|NCT01622790|"     Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in     phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations     (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of     tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line     regimen due in large part to its convenient presentation as a full treatment regimen in a     single product, other options are needed. A fixed-dose combination of DTG/abacavir     (ABC)/lamivudine (3TC) is one such opportunity. Part A of this study will be a single-dose,     two-treatment crossover pivotal bioequivalence (BE) evaluation of the DTG/ABC/3TC FDC tablet     in 66 healthy subjects. The reference formulations in this trial will be the 50 mg DTG tablet     that is currently being used in the Phase 3 clinical trials and the already marketed FDC     tablet product EPZICOM™ (ABC 600 mg/3TC 300 mg).It is intended that the results of this     pivotal bioequivalence study will show that the proposed commercial DTG/ABC/3TC FDC tablet     formulation is bioequivalent to DTG plus EPZICOM administered as separate tablets. Part B of     this study will evaluate the effect of a high fat meal on the FDC tablet in 12 healthy     subjects that have already participated in Part A of the study. There will be a screening     visit within 30 days prior to the first dose of study drug and a follow up visit within 7-14     days after the last dose. There will be a 7 day washout between doses in each treatment     period. The following PK parameters for DTG, ABC and 3TC will be measured: area under the     concentration curve from time zero (pre-dose) extrapolated to infinite time     (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the     time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration     (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax     (tmax), terminal phase half-life (t½), terminal elimination phase rate constant (λz),     percentage of AUC obtained by extrapolation (%AUCex),apparent clearance following oral dosing     (CL/F) and apparent terminal phase volume   "
126997|NCT01622777|"     To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid     peroxidation and nerve growth factor.   "
126998|NCT01622764|"     The research the investigators propose is a molecular imaging study of RO5323441, an antibody     against placental growth factor (PlGF) in patients with recurrent GBM treated with     bevacizumab, a drug against vascular endothelial growth factor (VEGF). Both VEGF and PlGF are     molecules involved in tumor growth since they enable the development of tumor vasculature,     thus delivery of oxygen and nutrients to the tumor. The treatment will consist of bevacizumab     (i.v.) given every 2 weeks, until the patient has clinical benefit (no disease progression)     or unacceptable toxicity. Meanwhile, patients will receive and injection of low protein-dose     radiolabeled RO5323441 (89Zr-RO5323441) on day -3 and 11 of the first bevacizumab treatment     cycle. Brain-only 89Zr-RO5323441 positron emission tomography (PET) will be performed at 2     hours after each injection of 89Zr-RO5323441 on day -3 and 11. Whole body 89Zr-RO5323441 PET     will be performed on day 1 and 15, before and after the first treatment with bevacizumab. The     main purpose of this trial is to determine how much of RO5323441 actually gets into the     recurrent GBM lesions, since for a drug to be active, it has to be able to reach cancer     cells. As second aims, RO5323441 accumulation in normal, non-tumor organs, will be assessed,     as well as how bevacizumab influences RO5323441 penetration into tumor lesions (to answer the     question of combined bevacizumab + RO5323441 treatment in GBM) or RO5323441 biodistribution     in non-tumor organs.   "
126999|NCT01622751|"     Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect,     and has been related to obstructive sleep apnea syndrome. In addition, children with     Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of     rapid eye movement (REM) sleep.      Objective: To determine if the sleep stages are related to the plasma levels of adiponectin,     resistin, and RBP4 (retinol binding protein-4), and whether these relationships are     influenced by age, obesity and insulin resistance.   "
127009|NCT01622608|"     The purpose of this study is to determine whether implementation of a web-based educational     intervention using a vaccine information kiosk placed in primary care practice waiting     rooms can reach a large number of parents and have a measurable impact on adolescent     vaccination rates, specifically for Tdap, HPV, meningococcal, and influenza vaccines.   "
127010|NCT01622595|"     OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS   "
127011|NCT01622582|"     Engraftment Syndrome after Autologous Stem Cell Transplant: Retrospective Review in Patients     with Multiple Myeloma   "
127108|NCT01621321|"     This is a research project to evaluate the efficacy and safety of two different treatment     protocols in Allergic bronchopulmonary Aspergillosis.   "
127000|NCT01622725|"     Since abdominal wall hernia repair is currently performed with the use of a mesh, side     effects associated with the mesh are frequently reported during long term follow-up. These     side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and     inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh     has been developed, which provides sufficient support and strength to allow efficient     recovery of the abdominal wall, but also disappear from your body in three years time, so     that you no longer have any synthetic material in your body. Previous resorbing meshes also     disappeared but over a much shorter period of time, so that the hernia was insufficiently     healed, with recurrence as a result.      The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made     of two commonly used polymers, however it will retain 50% of its initial strength after six     months. This in theory is enough to provide support of the collagen healing process during     the initial wound-healing phase, but also to support the transition of initial collagen to     functional collagen.      The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the     anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias     are not part of the study).      Therefore the patients will be divided into two groups, one group will be treated with a     resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will     be no difference in the medication or the surgical techniques used.   "
127001|NCT01622712|"     The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol     containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery,     quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a     multicenter (Belgian) prospective trial.      Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia     according the current surgical practice in the participating centers will be observed during     one year post-surgery, after which they will have a CT scan of the surgical area in the groin     to evaluate the mesh changes regarding shrinkage and migration.   "
127031|NCT01622322|"     The study is prospective and double blind. In the clinic, patients undergoing inguinal hernia     surgery that meet the criteria for inclusion into the study and agreed to participate in the     study will be randomized into two groups. In the first group of patients will receive Nitrous     Oxide and In the second group of patients will receive oxygen during the general anesthesia.   "
127002|NCT01622699|"     Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns.     Assessment of the degree of jaundice is usually done visually,and if necessary serum     bilirubin is investigated in a blood sample. The visual assessment is subjective and can     alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is     a validated measurement-tool, which provides us with an estimated serum     bilirubin-concentration. Little is known about the effect of the actual use of a     bilirubinometer on the quality of care. Further evidence is needed to evaluate whether     transcutaneous bilirubin measurements improve clinical outcome (use of blood tests,     phototherapy and exchange transfusion), shorten length of stay and reduce costs. Therefore we     aim to perform a Randomized controlled trial to evaluate the cost-effectiveness of     implementing the use of a transcutaneous bilirubinometer in jaundiced neonates, a gestational     age of 32 weeks. The assessment of jaundice by use of a transcutaneous bilirubinometer is     compared to visual assessment of jaundice   "
127003|NCT01622686|"     This randomized controlled trial seeks to test the effect of reformatted prescription drug     container labels, compared to usual labels, on participants' understanding of their     medications. The study will also assess the effect on self-efficacy and self-reported     medication adherence. English and Spanish speaking patients are eligible, with a planned     sample size of up to 500 adults.   "
127004|NCT01622673|"     This study will evaluate: (1) the effect of co-administration of single doses of calcium     carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma     pharmacokinetic profile of raltegravir in human immunodeficiency virus (HIV)-infected     participants; and (2) the effect of staggered dosing of a single dose of a magnesium/aluminum     hydroxide antacid 2 hours before and 2 hours after administration of raltegravir on the     steady-state plasma pharmacokinetic profile of raltegravir in the same participants.      The study will determine whether (1) the C12hrs of steady-state raltegravir after     co-administration of single doses of calcium carbonate antacid is decreased to a clinically     meaningful degree compared with C12hrs after administration of raltegravir alone; and whether     (2) the C12hrs of steady-state raltegravir after co-administration of a single dose of     magnesium/aluminum hydroxide antacid is decreased to a clinically meaningful degree compared     with the C12hrs after administration of raltegravir alone.   "
127005|NCT01622660|"     Gemcitabine and Cisplatin are standard chemotherapy drugs used to treat advanced urothelial     cancer. There is no standard chemotherapy for patients who cannot receive Cisplatin. However,     most patients are treated with the chemotherapy drugs Gemcitabine and Carboplatin.      In this study, the researchers hope to learn what effects, good and/or bad, the combination     of Gemcitabine and Pazopanib has on urothelial cancer. Gemcitabine is given intravenously     (through the veins) and works by killing rapidly dividing cells in the body, including cancer     cells. Pazopanib is an oral chemotherapy and works by decreasing the blood supply to tumors     which limits the tumor's source of oxygen and nutrients.      The combination of Gemcitabine and Pazopanib is being tested in research studies such as this     one. As of August 2011, more than 18 patients with various types of cancer have received     treatment with Gemcitabine and Pazopanib. The main goal of this clinical research study is to     learn if the study drugs Gemcitabine and Pazopanib can shrink or slow the growth of     urothelial cancer. The safety of this drug will also be studied. The physical state, changes     in the size of the tumor, and laboratory findings will help us decide if the combination of     Gemcitabine and Pazopanib is safe and effective.   "
127006|NCT01622647|"     The proposed study intends to investigate several aspects of the respiratory effects of     intravenous sedation of patients undergoing spinal anesthesia for knee replacement surgery.     The study will include assessment of PaCO2 during the intraoperative period. PaCO2 is     expected to be elevated as a result of intravenous sedation and postural factors. Further,     the study will investigate how application of Nasal Continuous Positive Airway Pressure     (N-CPAP) may impact PaCO2.   "
127007|NCT01622634|"     The objective of this study is to determine the combined effects of a high-protein diet and     high-intensity training on metabolic syndrome risk factors in women aged 30-65.   "
127049|NCT01622088|"     The purpose of the study is to collect long-term safety data from subjects with Amyotrophic     Lateral Sclerosis (ALS) exposed to dexpramipexole.   "
127131|NCT01621022|"     Focus of this study was to determine if bupropion was more effective for smoking cessation     when used alone or combined with nicotine gum.   "
127012|NCT01622569|"     The primary objective of this study is to compare the efficacy of intranasal administration     of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose     device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will     be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4     of the double-blind treatment phase measured by the 7 day average instantaneous AM diary     symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities)     over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale     score measured by nasoendoscopy.   "
127013|NCT01622556|"     This is a phase II study to assess the day 180 event free and overall survival after     administration of a specified combination of fludarabine, busulfan, Total Body Irradiation     (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant     in a single institution setting in patients with hematologic malignancies for whom allogeneic     transplantation is indicated.   "
127014|NCT01622543|"     The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/     bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.   "
127026|NCT01622387|"     During coronary bypass surgery, veins are taken from the leg and applied to the heart and     aorta to 'bypass' narrowings in the coronary arteries. However using an artery in the chest,     the internal mammary artery, means that the bypass lasts longer than using veins. The     investigators recently showed that using an artery from the arm as a bypass vessel, the     radial artery, also had less furring up than veins 5 years after surgery. Now the     investigators would like to ask patients to come back for an angiogram 10 years following     surgery.   "
127027|NCT01622374|"     To examine the pre-operative effect of music for the mind compared to some other styles of     music in patients undergoing dental procedures.   "
127042|NCT01622179|"     The purpose of this study is to estimate the effective of two suture methods in the treatment     of Achilles rupture.   "
127015|NCT01622530|"     Amputees often choose not to wear prostheses due to marginal performance or may settle for a     prosthesis that offers only cosmetic improvement, but lacks function. A simulation tool     consisting of a robotics-based human body model (RHBM) to predict functional motions, and     integrated modules for aid in prescription, training, comparative study, and determination of     design parameters of upper extremity prostheses will be developed.      The main objective of collecting and analyzing human movement during several common tasks is     to optimize and validate the robotics based human model. The range of motion data of subjects     performing activities of daily living such as opening a door, turning a wheel, grooming,     eating, bilateral lifting, as well as recreational and sport activities such as swinging a     baseball bat, and golf club will be analyzed. This motion analysis data will also be used to     compare data between four groups: a control group (n=10), a braced group simulating     prosthesis use (n=10), a group wearing a transradial prosthesis (n=10) and a group wearing a     transhumeral prosthesis (n =10).   "
127016|NCT01622517|"     The overall goal of the CTP to predict Response to recanalization in Ischemic Stroke Project     (CRISP) is to develop a practical tool to identify acute stroke patients who are likely to     benefit from endovascular therapy.      The project has two main parts. During the first part, the investigators propose to develop a     fully automated system (RAPID) for processing of CT Perfusion (CTP) images that will generate     brain maps of the ischemic core and penumbra. There will be no patient enrollment in part one     of this project.      During the second part, the investigators aim to demonstrate that physicians in the emergency     setting, with the aid of a fully automated CTP analysis program (RAPID), can accurately     predict response to recanalization in stroke patients undergoing revascularization. To     achieve this aim the investigators will conduct a prospective cohort study of 240 consecutive     stroke patients who will undergo a CTP scan prior to endovascular therapy. The study will be     conducted at four sites (Stanford University, St Luke's Hospital, University of Pittsburgh     Medical Center, and Emory University/Grady Hospital). Patients will have an early follow-up     MRI scan within 12+/-6 hours to assess reperfusion and a late follow-up MRI scan at day 5 to     determine the final infarct.   "
127017|NCT01622504|"     This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie     nasal spray (Test Product) and as a solution for injection (Comparator Product) administered     intranasally using a mucosal atomization device (MAD).   "
127018|NCT01622491|"     Excellent immune responses following 1 or 2 doses of the GSK monovalent AS03-adjuvanted     pandemic H1N1 (pH1N1) vaccines (e.g., Arepanrix®) have been documented in several trials.     Observational studies have found that these vaccines were effective in preventing laboratory     confirmed influenza infections. However, it remains unclear whether vaccination during the     pandemic was associated with reductions in more clinically meaningful outcomes, such as     hospitalizations, severe illness, complications, and death.      The investigators propose to evaluate the effectiveness of the GSK adjuvanted and     non-adjuvanted pH1N1 vaccines used in Manitoba in preventing hospitalization and severe     illness (defined as illness necessitating admission to intensive care or associated with     major complications) due to influenza or pneumonia by means of a case-control study using     data from Manitoba Health (MH) administrative databases and the database of the Cadham     Provincial Laboratory. The primary outcome will be hospitalization with laboratory-confirmed     influenza or pneumonia. A secondary outcome will be hospitalization with influenza or     pneumonia. The investigators will also assess the effectiveness of the above vaccines for     different age groups and among high-risk populations, e.g., immunocompromised individuals.   "
127019|NCT01622478|"     Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently     debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic     drainage thus causing lower SLN identification rate and higher false negative rate. Further,     the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can     accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to     determine the identification rate, the false-negative rate, and the accuracy of SLNB after     NAC for node positive breast cancer.   "
127020|NCT01622465|"     The aim of this study is to evaluate the effects of an exercise program with a cycle     ergometer in functional outcome and related-health quality of life (RHQL) in elderly patients     with total hip arthroplasty.   "
127021|NCT01622452|"     Postoperative cognitive decline (POCD) is a frequent complication after cardiac surgery. It     is estimated that 40-70% of all cardiac patients show cognitive dysfunction during the first     post-surgical week. Six weeks after surgery, this incidence decreases to 10-40% and the     figure remains stable over the long-term.      The investigators will recruit 50 patients undergoing elective valve surgery and each patient     will receive complete evaluation a) preoperative, one week before surgery; b) early     postoperative, before hospital discharge; and c) late postoperative, 8 weeks follow up.      The investigators will apply Diffusion Tensor Imaging, 1Proton-Magnetic Resonance     Spectroscopy and Morphometry studies with correlation to neuropsychological test battery to     evaluate POCD.   "
127132|NCT01621009|"     The purpose of this study was to determine if bupropion plus counseling was more effective     than bupropion alone or counseling alone in helping smokers quit smoking.   "
127022|NCT01622439|"     Patients with previously untreated diffuse large B-cell lymphoma will receive standard     treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison)     for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times     daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is     invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD     20-expression.      Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels     are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.   "
127023|NCT01622426|"     The investigators aim to assess the tolerance to a new commercially available Aaf in children     affected by IgE- or non-IgE-mediated CMA.   "
127024|NCT01622413|"     This study compares an endoscopic transforaminal surgical technique for the treatment of a     herniated disc to the standard microsurgical procedure. Clinical parameters as well as health     economy will be assessed.      The study hypothesis is that the endoscopic approach is equivalent or superior to     microdiscectomy.   "
127963|NCT01610128|"     The aim of the project is to develop a patient reported outcome instrument to assess disease     control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.   "
127032|NCT01622309|"     Cardiovascular diseases (CVD) prevail as the main cause of death in developed and developing     countries and are among the most frequent causes of disabilities in Brazil and in the world.      Economic alternatives have been studied to assist in reducing cardiovascular risk factors.     Within this context, the Solanum menogena, whose fruit known as eggplant is widely consumed     in Brazil, is being used in alternative medicine with the purpose to reduce the     concentrations of cholesterol, glucose and promote loss of body weight.      Aubergine (eggplant) stands out for its high fibre content (approximately 40%) and low fat     content. In addition, it is popularly known for its functional properties, aiding in reducing     the risk of coronary diseases. The purplish coloring of the eggplant peel is attributed to     the large amount of flavonoids, which have antioxidant properties and contribute to the     flavor of eggplant.      The investigators hypothesis is that the eggplant flour associated with a restricted calorie     diet has effect in reduction in waist circumference, reduction of body fat and increasing     HDL-cholesterol; this way, contributing to the reduction of cardiovascular risk factors      All participants will be informed about the research and they will have to sign a consent     form. The volunteers will be divided into two groups: one group will receive a     restricted-calorie diet and supplementation with eggplant flour; and the other will receive a     diet plus a placebo for 120 days, being both groups evaluated monthly. In each consultation,     evaluation of weight, body composition, fulfillment of the diet and blood pressure     measurement will be performed. In addition, blood will also be collected in order to     determine glucose, insulin, total cholesterol, LDL, HDL, triglycerides, oxidized anti-LDL     antibodies, 15-isoprostane and minerals (selenium, zinc, iron, manganese, magnesium and     copper). The results will be analyzed by statistical program.      The investigators expect that with the results obtained, the eggplant flour can be used as an     ally in the prevention of cardiovascular diseases.   "
127033|NCT01622296|"     The purpose of this study is to determine the effectiveness of buffered local anesthesia     injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine     with sodium bicarbonate may reduce the pain of injection for both adults and children. In     this study, the investigators will compare two local anesthetic preparations, a buffered     anesthetic and the conventionally available anesthetic, for pain upon injection.      Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection     compared to the acidic alternative used in most dental offices. This can be demonstrated by     comparing two local anesthetic preparations, a buffered anesthetic and the conventionally     available anesthetic, for pain upon injection.   "
127034|NCT01622283|"     This study will be a single center, open-label, randomized, single dose, in the fasted     condition and 2-way crossover study to evaluate the pharmacokinetics, the safety and     tolerability of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in Japanese     healthy male subjects.      Approximately 20 subjects will receive both treatments of levocetirizine oral solution 5 mg     and cetirizine dry syrup 10 mg in the design. Serial pharmacokinetic samples will be     collected and safety assessments will be performed following each dose.      The primary objective of the study is to demonstrate the bioequivalence of levocetirizine in     plasma, when given as levocetirizine oral solution 5 mg relative to cetirizine DS 10 mg in     Japanese healthy male subjects.   "
127035|NCT01622270|"     The objective of this study is to investigate the changes in crohn on resting energy     expenditure.   "
127036|NCT01622257|"     The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin     or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding     clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid     profile.   "
127074|NCT01621763|"     To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's     formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation     (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fed conditions and to     assess the bioequivalence.   "
127037|NCT01622244|"     The study will assess the effectiveness and cost-effectiveness of providing brief, intensive     case management for frequent users of hospital Emergency Departments who have mental health     and/or addictions problems. The goals of the intervention are to support patients' transition     to community-based health and social services and supports - including primary and urgent     psychiatric care, peer support and other community services and supports - so as to improve     patient wellbeing and reduce avoidable ED visits and hospitalizations.   "
127038|NCT01622231|"     Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese     paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will be evaluated.     And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray     over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial     allergic rhinitis will also be evaluated.   "
127039|NCT01622218|"     The purpose of our study to quantitatively examine the stress levels prior to surgery and the     use of analgesics post surgery in both children and their parents following a preoperative     intervention with a medical clown compared to children that were not exposed to this     intervention.   "
127040|NCT01622205|"     Stroke is a generic term for cerebral infarction and cerebral haemorrhage and accounts for     more patient days than any other single condition in Swedish health care. The Swedish     guidelines for stroke treatment, issued by the national board for health and welfare,     recommend early supported discharge for people with mild to moderate stroke. This is based on     studies in which mean hospitalization was 18 days. The average length of stay in Sweden is 12     days. Policy makers would, however, like to shorten length of stay even further, and many     patients are anxious to get home. Where and how to get support at home after discharge     varies.      This study is a randomized controlled trial in which half of the subjects are randomly     allocated to very early supported discharge and the other half receives usual treatment. The     investigators believe that patients discharged very early with support will experience less     anxiety compared with controls. The investigators believe that early supported discharge is     safe and that there is no difference between groups in bodily function. In order to test     differences between the groups, the study requires approximately 110 subjects.      Everyone who comes to the stroke unit at the hospital with a mild to moderate stroke can be     recruited to the study. The intervention is having a team from the stroke unit visiting the     patient's home and train him/her according to the individualized goals. The controls are     discharged according to routine with support from primary care if needed. Assessments are     made by therapists who are not involved in the training upon returning home, at 1 month, 3 to     12 months. The assessments include anxiety, motor activity, gait and balance, and ADL.     Interviews will be done to highlight the subject's own experience.      It is important to evaluate new methods and organizational changes prior to their     implementation in health care. The investigators hope to show that very early supported     discharge with rehabilitation is safe and provides confidence and less anxiety. Then it is     possible to introduce a method that simultaneously improves patient outcome and increases     availability of hospital beds.   "
127041|NCT01622192|"     The aim of the study is to determine the best method for measuring the extent and severity of     the gum disease by comparing the repeatability of probing depths achieved by a manual probe     when compared to an automated probe.      Hypothesis      The null hypothesis to be tested includes        -  The automated probe does not improve the reproducibility of periodontal probing when          compared to manual probing recordings        -  The automated probe shows no advantage when comparing the reproducibility of             -  Moderate sites             -  Deep sites             -  Single vs. multirooted teeth             -  Different sextants             -  Different surfaces of teeth Buccal vs. palatal/lingual Mesial vs. mid vs. distal   "
127043|NCT01622166|"     Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic     art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of     schizophrenia compared to a group of patients receiving treatment as usual.      *Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission     compared to TAU.      *Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing     function, self-efficacy and neuroleptic dosage compared to TAU.   "
127044|NCT01622153|"     1. The investigator hypothesize that the Laser pulpotomy will provide adequate and          comparable success clinically in primary molars.        2. The investigators hypothesize that the Laser pulpotomy will provide adequate and          comparable success radiographically in primary molars.   "
127045|NCT01622140|"     This is a prospective cohort study of persons tested for latent tuberculosis infection at     either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to     tuberculosis disease. The study will assess the relative performance and cost of three     diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold     In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This     study will also determine the risk and rate of progression to active TB disease, overall and     by the results of the three tests.   "
127046|NCT01622127|"     A novel concept of self-gripping mesh has been developed to achieve secure and long-term     posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament     polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which     provide self-gripping properties during the first few months after implantation. The     self-fixation of the mesh to the underlying tissues is instantly achieved at application,     limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and     damage cutaneous nerves), and providing a near tension-¬free repair.      Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and     painless treatment of incisional hernias and provides secure and efficient fixation mesh. On     this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional     hernia defect treatment. In order to assess the clinical outcomes following the use of     ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has     been initiated.   "
127047|NCT01622114|"     Achievement and maintenance of weight loss in obese individuals has proven difficult. Many     hypotheses have suggested potential biological mechanisms to explain why weight loss attempts     often fail, and the surrounding obesogenic environment also seems an obvious candidate. Among     the biological factors proposed is gender, and weight loss trials have frequently shown that     females are less successful than males at losing weight and at maintaining weight loss.      Women's weight is influenced by the menstrual cycle, in which changes in hormonal levels and     interactions work to modulate fertility. These hormones control the menstrual cycle and     coordinate the required changes in energy intake, expenditure, and storage, whilst preparing     the body for pregnancy every month. As reproduction is a primary biological function, these     hormones may be such strong mediators of eating behavior that they influence the outcome of a     weight loss attempt. The menstrual cycle should therefore be taken into consideration as a     factor in the physiology of energy balance in premenopausal women.      The cycle can be divided into three phases: menstruation or early follicular phase (days     1-5), late follicular phase that lasts until ovulation (~days 6-14, and the luteal phase     (days 15-28).      Studies have shown that in the luteal phase of the menstrual cycle, women's energy intake and     energy expenditure are increased and women experience more frequent cravings for foods,     particularly those high in carbohydrate and fat, than during the follicular phase. A trend     towards reduced carbohydrate utilization and increased fat oxidation in the luteal phase has     also been reported, together with prolonged time to exhaustion when exercising at submaximal     intensities. This suggests that the potential of the underlying physiology related to each     phase of the menstrual cycle may be worth considering as an element in strategies to optimize     weight loss.      In 2010 the investigators carried out a 90-day randomized, controlled pilot study in order to     gain feedback on and assess acceptance of the meal and exercise plans being used and to     observe if less control visits than planed in the main study were sufficient to achieve good     compliance. Twenty eight were sreened and 24 were included. Subjects were randomized to     either program A (given meal and exercise plans in relation to phases of their menstrual     cycles) or Program B (a reduced calorie diet, calorie-matched to program A). The pilot study     showed that Group A (The Menstralean group) tended to have a greater average weight loss at     60 days (-5.29 vs -3.57 kg, p = 0.06) and 90 days (-4.22 vs -2.75 kgs, p = 0.2) compared to     the control groups. There was a dropout rate of 27%. This was primarily due to an inadequate     number of control visits and contact with the subjects. Thus the Menstralean program seems to     have the potential to enhance weight loss in overweight and obese women. However, the main     study has to be carried out with more subjects in each group in a longer duration and with     more support and contact with the subjects.      The aim of the present trial is to examine the impact of the menstrual cycle on weight loss     attempts in healthy overweight (BMI > 27 kg/m2) premenopausal women (18-40 years) randomized     to two different weight management programs for a period of 6 months.   "
127048|NCT01622101|"     Background: Zantrex-3® is a popular dietary supplement for weight control, which consists of     a combination of yerba mate, guarana, caffeine and damiana. The combination has previously     been shown to decrease gastric emptying and its weight controlling effects may be related to     increased satiety and thermogenesis.      Objective: To investigate the effect of Zantrex-3® on energy expenditure, hemodynamic factors     and subjective appetite sensations.      Design: Twenty-three men (BMI: 23.9±3.2 kg/m2, mean±SD) participated in a randomized,     double-blind, placebo-controlled crossover study. The Zantrex-3® compound contained 365 mg     xantines (caffeine and caffeine-like stimulants), yerba mate, guarana and damiana. The     thermogenic effect was measured for 3 hours post-intake. Blood pressure (BP), heart rate (HR)     and appetite ratings were assessed every half hour.   "
127050|NCT01622075|"     The purpose of this study is to evaluate the efficacy and safety of successful interventional     therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent     restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area)     versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary artery     stenosis is 2.5mm-4.0mm and the length ≤30mm.   "
127051|NCT01622062|"     The purpose of this study is to assess the 4-site one-week post-exposure prophylaxis (PEP)     regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.      Primary objective:        -  To demonstrate that PEP using the new one-week, 4-site (4-4-4-0-0) intradermal PEP          regimen (with and without rabies immunoglobulin), is non-inferior to PEP using the          updated TRC (2-2-2-0-2) ID PEP regimen with rabies immunoglobulin in terms of          seroprotection rate at Day 14.      Secondary objectives:        -  To describe the immune response in each group at Day 0, Day 14 and Day 90.        -  To describe rabies virus-neutralizing antibody persistence during the 5 years after          completion of PEP in each group.        -  To describe the immune response induced by a single-visit 4-site intradermal (ID)          booster vaccination in each group at Year 5.        -  To describe the safety profile of each treatment group after the primary and booster          vaccinations.   "
127052|NCT01622049|"     Patients undergo a detailed ultrasound examination to rule out the presence of congenital     anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS     will be considered candidates for the trial. Patients will be counseled about the risks and     benefits of all treatment options and will be free to choose any treatment option. They will     then be asked to sign an informed consent. The procedure will be performed under local     anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be     introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be     located endoscopically and will be lasered with YAG laser energy. An accessory port may be     required in some cases. The procedure will be monitored both endoscopically and     sonographically. The presence of fetal heart activity will be noted often during the     procedure. An amniodrainage of the larger sac may be performed at the time of the procedure.     The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on     the first post operative day. Patients will undergo a weekly ultrasound examination for four     weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will     include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders,     absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein,     ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their     corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive     care unit will be followed through their discharge. Evidence of neurological or cardiac     morbidity will be sought in each twin. If either of these complications is suspected,     evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be     followed up for neonatal, infant and childhood morbidity or mortality. It is requested that     all placentas be delivered fresh to Tampa General Hospital in an icebox container for     assessment. Placentas will be discarded after analysis.   "
127066|NCT01621867|"     Cystic fibrosis is a genetic condition where epithelial cells, including from the respiratory     tract, have an abnormal function of a surface protein, the cystic fibrosis transmembrane     conductance regulator (CFTR) protein resulting from abnormal gene expression. The trial will     assess the clinical efficacy, safety & tolerability and gene expression following repeated     nebulised doses of a gene product coding for a normal CFTR protein, with the primary outcome     of the trial assessing lung function.   "
127138|NCT01620931|"     This randomized, observer-blinded, placebo-controlled study will assess the safety,     tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers.     Subjects will be randomized in cohorts to receive single ascending intravenous or     subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4,     with a safety follow-up of 15 weeks after dosing.   "
127053|NCT01622036|"     It is estimated that up to 30% of cancer patients die because of the effects of malnutrition,     caused by a discrepancy between nutritional needs and intake (or utilization) of energy and     essential nutrients. Malnutrition and its severe complication, cancer cachexia, are negative     prognostic factors in neoplastic patients, inducing Decreased response and tolerance to     antineoplastic treatments, decline in the functional status, reduced quality of life and     reduced survival. Prevalence data on malnutrition in italian oncology patients are lacking     and the available literature data on weight loss and malnutrition in oncology refer to     patients in different phases of disease and therapy. Most importantly , strategies for     prevention of malnutrition and cachexia in oncology are still largely disregarded and     scarcely implemented.      The main objective of this project is to assess the prevalence of malnutrition in patients     undergoing first medical oncology visit in Italy. Secondary objective is to increase     awareness of metabolic and nutritional issues among medical oncologists, thus favoring the     inclusion of metabolic-nutritional screening and monitoring in medical oncology protocols.     This would in turn contribute to reduce the negative consequences of malnutrition- and     cachexia-related complications.   "
127054|NCT01622023|"     The aim of the present study is to prospectively evaluate whether performing an intra-uterine     insemination 24 hours after the spontaneous LH peak may result in significantly higher     ongoing pregnancy rates compared to 48 hours.   "
127055|NCT01622010|"     The purpose of this research is to determine if there is a greater behaviour change in self     management of heart failure following reinforced multimedia education focusing on physical     activity as compared to standard care. It is the investigators belief that participants who     receive DVD education in addition to usual care will show improved self management in     comparison to receiving usual care alone. The investigators anticipate fewer hospital     admissions due to improved self care management.   "
127056|NCT01621997|"     To examine whether retraining via operation inspection or verbal education can reduce the     risk for peritonitis in PD patients.   "
127057|NCT01621984|"     The purpose of this current prospective study is to assess the effects of a Therapeutic     Riding exercise program conducted in patients suffering from neuromuscular disease. The     exercise intervention aims at improving gross motor function, gross motor performance,     balance, spasticity, posture and quality of life. Patients were randomized according to age,     sex, mental ability and gross motor function. Furthermore, patients will be subdivided into     categories of central nervous system (brain/ spinal cord) and peripheral (peripheral nerve or     muscle) diseases. The exercise program duration will be 12 weeks, once a week with 30-40     minutes sessions. Six measurements will be conducted: the Gross Motor Function Measure, the     Gross Motor Performance Measure, the Quality of life Questionnaire for Children, the     Pediatric Balance Scale, the dynamic plate in combination with x-ray for posture control, the     Modified Ashworth Scale for spasticity and the Wisc 3 for mental ability. The results will be     collected and evaluated using the statistical programme SPSS.   "
127058|NCT01621971|"     Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary     arterial pressure due to severe mitral valve regurgitation without compromising systemic     hemodynamics. Therefore, the effects of a brief inhaled milrinone (IH) on pulmonary artery     pressure are determined and compared to those of intravenous milrinone (IV) in severe mitral     regurgitation patients undergoing mitral valve surgery.   "
127059|NCT01621958|"     Slip-related falls often cause injury; these often have catastrophic consequences, even among     the healthiest older persons. Establishing a retainable preventive training regimen against     slip-related falls would, without doubt, have major public health implications. In this     study, investigators will demonstrate that older adults can significantly reduce their     near-term risk of backward balance loss and falls through motor training with multiple     protected slip exposure, and such adaptive improvements from such prophylactic training     regimen can be retained over the course of a year.   "
127061|NCT01621932|"     Randomized prospective study comparing the anterior capsule repair vs capsulectomy with     regards to post-operative pain and range of motion outcomes in elective primary unilateral     direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded     for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by     goniometer measurements and lateral hip radiographs in maximum flexion.      The purpose of the study is to compare post-operative pain control and hip range of motion     between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during     direct anterior total hip arthroplasty.   "
127062|NCT01621919|"     S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and     Western GC patients. Recently, some case and small-sized studies have been reported on     lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct     secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected     to be high in patients who developed LDO than in patients without LDO. We investigate the     concentration of S-1 and its metabolites in tear and plasma and find out its correlation with     side effects such as LDO. These results will also help us identify patients who are at high     risk of developing S-1-associated side effects.   "
127063|NCT01621906|"     The purpose of this study is to compare two different imaging methods to examine the response     of brain metastases to WBRT. These two imaging methods will take pictures of the brain using     : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI)     scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive substances also     called as radioactive markers to see cancer cells. We plan to use [18F]FLT as a radioactive     marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. It is in     the testing stage of development unlike FDG-PET which is used more commonly used. Therefore,     this is considered a research study. This will help us evaluate whether this scan will be     safe and better used in the future to evaluate tumors. The amount of radiation to the body is     small. The radiation from the radiotracer drug will be gone from the body in a few hours.     There is no radiation risk from the MRI scans. Additionally, we also plan to use MRI imaging     of the brain. We expect that [18F]FLT PET is better when compared to MRI and will give us     more information about the brain metastases after WBRT.   "
127065|NCT01621880|"     Bevacizumab may have a better effect on brain necrosis caused by radiotherapy.This randomized     trial aims to investigate whether bevacizumab may alleviate radiation-induced brain necrosis     in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in     patients receiving steroid therapy.   "
127067|NCT01621854|"     This is a two-part Phase I, open label, dose-escalation, study of NUC-1031 as a single agent     in patients with advanced solid tumours who have failed to respond to or who have relapsed     after treatment with standard therapy. NUC-1031 is a ProTide of gemcitabine, a drug that has     been used widely and effectively against cancers for many years. Both NUC-1031 and     gemcitabine work by preventing cancer cells from dividing by attacking their DNA     (deoxyribonucleic acid). Non clinical studies have shown that NUC-1031 is more effective than     gemcitabine because it is able to reach cancer cells by passive diffusion, is less easily     degraded by the cancer cell, and delivers the monophosphate form of the active agent. The     first part of the study is to determine recommended phase 2 dose by dose escalation and the     second part is to explore preliminary anti-tumour activity.   "
127068|NCT01621841|"     Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide.     IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is     observed for normal tension glaucoma. Some studies have reported lesions of the optical     pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing     spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us     to analyze visual pathways and to determine the association with neurodegenerative diseases     as Alzheimer.      The investigators propose to compare volume and structure of the visual pathways between     glaucoma patients and healthy subjects matched on age and sex.      Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells,     visual field deterioration and optic nerve cupping. Some studies have suggested that all the     visual pathways could be damaged in glaucoma. Recently, a German study proved a significant     reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T.     Some authors have also suggested that glaucoma could share similarities with the other     neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual     pathways with a high level of spatial resolution.Fractional anisotropy is a tag of     microstructure.   "
127069|NCT01621828|"     The aim of this study is to investigate a possible reduction in pre-operative anxiety in     patients undergoing major elective surgery, by providing multimedia information regarding the     patient pathway to and from the Operating Theatre.   "
127070|NCT01621815|"     As the use of video games (VG) is rapidly increasing, many studies have tries to understand     the effects of VG on the children and adolescents playing them.      Most of the research was directed towards negative effects (especially violence, attention     and school performance), producing mixed results.      Recently, more studies had focused their attention on the opposite angle: The influence of     the player's mental and behavioral parameters, influencing his VG playing patterns. The focus     of most of these researches was time of playing, addictive patterns and exposure to violence.      The current study will try to characterize the variance of VG playing pattern among     adolescents diagnosed with psychiatric disorders, in order to better under the rich     interaction between a player and his VG, and to understand whether VG playing patterns holds     diagnostical clues for the child's diagnosis and his inner world.   "
128453|NCT01603719|"     The purpose of this clinical trial is to evaluate the effect of a new infant starter formula     with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.   "
127077|NCT01621724|"     WT1 TCR gene therapy is a new treatment for acute myeloid leukaemia and chronic myeloid     leukaemia.      Patient's white blood cells (T cells) are modified to specifically fight the leukaemia cells     by transferring a gene into the T cells, which allows them to recognize fragments of a     protein called WT1. This protein is present on the surface of leukaemia cells at very high     levels. The gene transferred to the T cells enables them to make a new T cell receptor (TCR),     which will allow them to attack leukaemia cells with high levels of WT1 on their surface.      Using this form of gene therapy the investigators can convert some of the patient's immune     system's own T cells into T cells that the investigators hope will be much more effective at     recognizing and killing leukaemia cells.   "
127078|NCT01621711|"     This component of a larger Center of Research Excellence Grant improves treatment for drug     abuse by developing effective linkages between specialty drug treatment and primary health     care.   "
127079|NCT01621698|"     This project involves looking at the timing of providing pain relief for patients who are     having lung surgery via the use of a small camera inserted into the chest with a scope (Video     assisted thorascopy). This procedure can be the source of intense pain both immediately after     the procedure and in the longer term leading to chronic pain problems.      Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal     column, where the pain nerve fibres are located, is a well recognized method of providing     pain relief for these procedures. It is currently unclear as to the best timings for     providing this type of pain relief with some centres placing the local anaesthetic at the     start of the procedure and some at the end. Placing a high volume of local anaesthetic into     this area at the start of the case may provide better short and long term pain relief than     placing it at the end of the procedure. The investigators hope to show a difference between     the two timings to allow for better pain relief for these procedures. This would be a     feasibility study that would lead onto a multicentre trial to eventually create a best     practice protocol for pain relief for lung resection via this surgical method.   "
127080|NCT01621685|"     In 2004, the investigators initiated a human Capsaicin inhalation experiment under an     Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject     safety procedures instituted and approved by the Institutional Review Board (IRB). As part of     the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid     chromatography (HPLC). The investigation employed safety procedures while conducting the     human inhalation investigations. In addition, during our investigations we observed     discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist     and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin     solutions stored over a seven month period and refrigerated at 4degrees C and protected     against ultraviolet light were examined.   "
127081|NCT01621672|"     The purpose of this study is to determine in a phase II trial, whether further maintenance     therapy with Revlimid can extend the duration of progression-free survival and the duration     of complete or near complete response compared to no further therapy beyond the TT3     protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years     with VTD (2003-33) or VRD (2006-66).   "
127082|NCT01621659|"     People with breast cancer and lymphoma often experience many short and long-term side effects     as a result of both the cancer and the necessary treatments.      Receiving extra assessments and care from teams of multiple health professionals has been     shown to be helpful for people with other health problems, such as heart disease. These     'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise     therapists, counselors, and other specialists. Currently, the investigators do not know if     receiving extra assessments from a multidisciplinary team is helpful for people receiving     cancer treatment.      In this study, the investigators hope to learn the effect of extra assessments and early     interventions from teams of health care professionals in people diagnosed with cancer, during     and after the treatment period.      After initial assessments, participants will be randomized to multidisciplinary team     intervention or usual care.   "
127084|NCT01621633|"     This is a study to characterize the pharmacokinetics as well as safety and tolerability of a     single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment     compared to matched healthy subjects   "
127085|NCT01621620|"     objectives        1. To study the sympatho-vagal balance effect on different limbs of pain perception.        2. To determine whether it is the hypertension by itself or the baroreflex activation due          to blood pressure rise that is responsible for the analgesic effect of acute          hypertension.      study questions      The study questions are derived from the study objectives:        1. Does sympatho-vagal balance influence pain perception?        2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?        3. Does sympatho-vagal balance influence temporal summation?        4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex          activation?   "
127086|NCT01621607|"     Background:      - The risk for becoming addicted to drugs varies among individual, even those using similar     drugs in a similar way. It is not known why some people become addicted and others do not.     Studies suggest that some genes may increase the risk of addiction. Negative life experiences     may also affect the risk of addiction. Researchers want to test smokers and nonsmokers to     study genetic and brain function traits that may lead to drug addiction.      Objectives:      - To understand brain function in people who may be at a higher risk of drug addiction.      Eligibility:        -  Healthy volunteers between 18 and 55 years of age.        -  Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be          eligible.      Design:        -  Participants will be screened with a physical exam and medical history. They will be          tested for drug and alcohol use. A blood sample will be collected.        -  The study will involve one visit. Participants will have a magnetic resonance imaging          (MRI) scan.        -  At the visit, participants will answer questions about their health and drug use habits.          They will then be trained on the tasks they will do during the MRI scan. After the          training, they will have the scan and perform the tasks. The scan and tasks will look at          brain function related to rewards and impulsiveness.        -  Other computer tests will be given after the scan. These tests will measure learning,          memory, and impulsiveness.   "
127087|NCT01621594|"     Title: Evaluating New Radiation Techniques for Cardiovascular Imaging      Background:      - Imaging studies such as computed tomography (CT) scans involve the use of radiation to     create the pictures. Heart and blood vessel CT scans can cause high radiation exposure.     Different methods of creating CT pictures have been developed to reduce the radiation dose.     Researchers want to see how effective these new methods are in producing accurate CT scans.      Objectives:      - To study new ways of taking pictures of the heart or blood vessels using computed     tomography.      Eligibility:      - Adults at least 18 years of age who will be having imaging studies to help detect heart or     blood vessel problems.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be taken to check kidney function.        -  Participants will have a CT scan of the heart and blood vessels. A contrast agent may be          used to improve the quality of the images. The scanning session may last up to 2 hours.        -  Participants will have follow-up contact 90 days after the scan, and then yearly contact          for the next 5 years.   "
127088|NCT01621581|"     Background:      - Glial cell line-derived neurotrophic factor (GDNF) is a chemical that may help protect and     strengthen brain cells that produce dopamine. Dopamine is a chemical that affects brain     function. People with Parkinson's disease (PD) have problems producing dopamine in the brain.     Researchers want to see if gene transfer can help deliver GDNF into the area of the brain     that is damaged by PD. The gene transferred in this study, called AAV2-GDNF, may help produce     GDNF to protect the damaged brain cells.      Objectives:      - To test the safety and effectiveness of AAV2-GDNF gene transfer for advanced PD.      Eligibility:      - Individuals at least 18 years of age who have advanced PD that is not well controlled by     medications.      Design:        -  Participants will be in the study for about 5 years. There will be 18 outpatient study          visits and a 3-day stay in the hospital. There may also be overnight stays for followup          visits.        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected. Tests of PD symptoms and mood and memory will be given. Imaging          studies will be used to find the right part of the brain to infuse the gene. The          screening visit will take place up to 60 days before surgery.        -  Participants will have a baseline visit about a month before the surgery. For 1 week          before the baseline visit, participants will keep a diary on any motor problems. The          visit will involve movement tests given before and after taking a regular dose of          levodopa.        -  Participants will have surgery to infuse AAV2-GDNF into the brain. The surgery will also          include a lumbar puncture (spinal tap) to collect cerebrospinal fluid. After surgery,          participants will recover in the hospital for at least 2 days.        -  Participants will have another lumbar puncture 6 and 18 months after surgery. This will          be an outpatient visit.        -  Participants will have regular followup visits after the surgery. These visits will          include neurological tests and movement studies. Visits with a neurosurgeon will take          place 1, 2, and 4 weeks after surgery. Additional visits will take place every 3 months          for the first 3 years, and then at longer intervals for up to 5 years.   "
127121|NCT01621152|"     Introduction: Acute kidney injury (AKI) increases mortality, hospital cost, and rate of     progression toward end stage kidney disease 1-4. Early diagnosis and management of AKI is     known to improve the above mentioned outcomes.      Hypothesis: the investigators will design and validate an electronic surveillance tool to     screen all the ICU admissions for the earlier, more efficient diagnosis of AKI and as a     result improve the outcome of AKI in ICU patients.      Methods: the investigators plan to use the patient database, and AKIN (AKI network)     definition to design an electronic alert system to allow clinicians discover patients who     develop AKI. Then a randomized clinical trial will be conducted to compare earlier     intervention (based on Kidney Disease: Improving Global Outcomes [KDIGO] guidelines)     initiated by AKI sniffer alert to the conventional management provided by primary physician     in ICU.   "
127122|NCT01621139|"     The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the     requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite     recovery process, and 4) improve the quality of life.   "
127089|NCT01621568|"     Background:      - Sunitinib is drug that is approved for treating various types of cancers, including kidney     cancers. However, it has not been approved to treat cancers of the thymus. Sunitinib works by     blocking proteins that are responsible for cell division and growth. Some of these proteins     can be found on thymus cancer cells. Researchers want to see if sunitinib can be used to     treat advanced thymus cancer. It will be given to people who have had at least one earlier     chemotherapy treatment containing platinum.      Objectives:      - To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has     not responded to earlier treatments.      Eligibility:        -  Individuals at least 18 years of age who have advanced thymus cancer that has not          responded to earlier treatments.        -  At least one previous cancer treatment must have been chemotherapy treatment containing          platinum.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies and tumor biopsies will be used to check the          severity of the cancer.        -  Participants will take sunitinib tablets once a day, in the morning. They will take the          tablets daily for 4 weeks, followed by 2 weeks of rest with no sunitinib. This 6-week          period is called a cycle.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Treatment cycles may be repeated as long as the tumor does not continue to grow and          there are no severe side effects.   "
127090|NCT01621555|"     The purpose of this study is to investigate whether there is a correlation between a patients     pain sensitivity and their subsequent post-operative pain and surgical outcome in     arthroscopic shoulder surgery.   "
127091|NCT01621542|"     This clinical study is designed to evaluate the safety, immunogenicity and antitumor activity     of WT2725. WT2725 will be administered to patients with advanced malignancies known to     overexpress WT1   "
127092|NCT01621529|"     Use of positron emission tomography (PET) in determination of functional tumour volume can     provide usable information for radiotherapy to define the irradiated volume.      To determine the best tumour volume measure method, the investigators have chosen as model     the breast cancer which allows us to study a stationary or moving organ by the patient     position and belonging to a primary surgery.      The used methodology is based on lesion volume measure in preoperative time, obtained with     PET, and on the measure of specimen volume by the anatomic laboratory after surgery.      This study's main objective is to compare this two measure of tumour size and secondarily to     compare TEP with or without respiratory gating.      The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3     times:      A whole body acquisition in supine position, follow by a centered tumour acquisition with     respiratory gating, then an acquisition in prone position to immobilise the lesion.      This study is monocentric and descriptive. It provides to include 30 patients in 1 year.   "
127093|NCT01621516|"     Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a     tendency to develop in the long-term diabetes. Patients who have received extra pancreatic     tissue with their liver and small bowel transplantation have not yet developed insulin     resistance or diabetes mellitus. We would like to investigate to which level insulin     secretory capacity the extra pancreas together with the native pancreas has in these     transplant patients using the hyperglycemic clamp. These data will be compared with the data     obtained from healthy controls.   "
127094|NCT01621503|"     The primary objective of this clinical study is to collect clinical data to support an FDA     510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective     is to evaluate any adverse events found during the clinical study.   "
127095|NCT01621490|"     The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab     in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood     and tumor tissues of subjects with advanced melanoma (unresectable or advanced)   "
127096|NCT01621477|"     The primary aim of this protocol is to evaluate if the one-year survival is significantly     improved in the group of patients who receive a T-cell replete haploidentical donor     hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen.     Study population will consist of patients (21 years or under) with hematologic malignancies     that have relapsed or are refractory after prior allogeneic transplant. Toxicity will be     evaluated by the rate of transplant related mortality and the rates of moderate and severe     graft-versus-host disease (GvHD) at day 100. The investigators will describe event-free, and     disease-free survival at one year, as well as the rates of hematopoietic recovery and donor     engraftment and study comprehensively immune reconstitution following T-cell replete     haploidentical transplantation.   "
127097|NCT01621464|"     Physiological stimulation therapy effectiveness will be proved with contractility sensor or     CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from     neuromediated syncope. Furthermore, not only will be investigated if this system eradicates     syncopes, but also if the number of presyncopal episodes is reduced.   "
127123|NCT01621126|"     In a study performed by the Harvard Shoulder Service, it has been documented that there is a     significant incidence of neurologic complications of the Latarjet procedure for shoulder     instability. 5 out of 52 patients had neurologic complaints post-operatively. 3 of these     nerve palsies were transient, however 2 had not yet recovered fully at time of latest     follow-up and returned to the operating room for exploration and neurolysis of the axillary     nerve and brachial plexus.      By using intra-operative neuromonitoring to determine exactly when there is a potential nerve     injury during the procedure, the investigators will be able to modify what the investigators     do at that step of the procedure, in order to decrease or possibly even eliminate the risk of     neurologic injury.   "
127124|NCT01621113|"     The purpose of this study is to determine the efficacy, safety, and tolerability of treatment     with dalfampridine in combination with locomotor training in persons with chronic, motor     incomplete SCI.   "
127125|NCT01621100|"     The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily     OROS (Osmotic Release Oral System [a controlled release oral medication delivery system in     the form of a tablet]) hydromorphone for cancer pain treatment in Korean cancer patients.   "
127174|NCT01620450|"     This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced     by current process and the NN2000 process in healthy Japanese subjects.   "
127098|NCT01621451|"     Aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular     or cerebrovascular disease with an aging society in Korea. Also, the patients having     endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for early     gastric cancer or gastric premalignant lesions including adenoma and dysplasia are increasing     among aspirin and/or clopidogrel users. Practically, aspirin or clopidogrel is recommended to     be stopped for 5~14 days before EMR or ESD because bleeding risk during or after procedure.     And it is recommended to restart of aspirin and/or clopidogrel as soon as possible if     immediate bleeding during or after the procedure is not occurred in consideration of     thromboembolic risk. However, early restarting of aspirin and/or clopidogrel raise the risk     of delayed bleeding and the risk of complications associated with delayed ulcer healing.     Although it is important to determine the timing of restarting aspirin and/or clopidogrel in     consideration of complications of post-EMR/ESD ulcer and thromboembolic risk, there is no     definite guideline about the timing of restarting aspirin and/or clopidogrel.      This study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the     patients having EMR or ESD among aspirin and/or clopidogrel users. The investigators planned     to compare the delayed bleeding rate and ulcer healing rate in patients with post-EMR/ESD     ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients     restarting aspirin and/or clopidogrel within 3~4 days after the procedure and the patients     restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. The primary     endpoint is delayed ulcer bleeding rate at 4 weeks after EMR/ESD. The secondary end point is     ulcer healing rate within 4 weeks.   "
127099|NCT01621438|"     This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel     fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel     disease. For this purpose, the clinical data of the patients with 3-vessel intermediate     coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical     needs, will be analyzed.   "
127100|NCT01621425|"     Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers,     mainly breast- and metastatic castration-resistant prostate carcinoma.      Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to     equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly     interindividual pharmacokinetic variation leading to toxicity and under-treatment.      The investigators will determine which anthropometric parameters, LBM, total body weight     (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.   "
127101|NCT01621412|"     The investigators believe that disclosure of HIV status could influence medication adherence.     If disclosure leads to social support, adherence could be improved. This study purpose is to     assess correlation between disclosure and medication adherence, and to describe people whose     HIV status has been disclosed to.   "
127102|NCT01621399|"     The purpose of this study is to determine if product 55394 is safe and efficacious for the     treatment of bacterial vaginosis.   "
127103|NCT01621386|"     This study will explore the utility of magnetic resonance imaging (MRI) to assess ventilatory     defects that occur due to asthma, determine the sensitivity and specificity of MRI in     response to drug treatment, and whether MRI can serve as a biomarker of treatment effects due     to asthma therapy.   "
127104|NCT01621373|"     The aim of the study is to explore the optimal propofol dose in neonates receiving a single     intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE     (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective     non-INSURE procedures (term-preterm neonates).   "
127105|NCT01621360|"     The objective of this study is to determine if patients with femoroacetabular impingement     (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years     post-operative with respect to physical function, pain, and health related quality of life,     compared to similar patients who receive conservative management, including medication and     physiotherapy.   "
127106|NCT01621347|"     The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy     and postpartum, and to record adherence barriers and facilitators.   "
127109|NCT01621308|"     Almost all patients with type 1 diabetes mellitus (T1DM) need insulin treatment permanently.     For selected patients who are unable to achieve glycaemic targets with subcutaneous (SC)     insulin treatment, continuous intraperitoneal (IP) insulin infusion is an third-line     alternative.      Previous studies demonstrate that continuous intraperitoneal insulin infusion (CIPII) using     an implantable pump device improves glycaemic control and quality of life in patients with     'brittle' T1DM. Nevertheless, literature comparing IP and SC insulin treatment is scarce.      The primary objective of this study is to compare the effects of IP insulin delivery to SC     insulin delivery.The null hypothesis (H0) of the current study holds inferiority of CIPII     compared to SC insulin regarding long-term glycaemic control. The alternative hypothesis (H1)     is the inverse: CIPII is non-inferior to SC insulin. In summary, H0: CIPII is inferior to the     SC insulin treatment H1: CIPII is not inferior to SC insulin treatment      This is an investigator initiated, open label and prospective matched-control study with a     non-inferiority design. The trial duration is 36 weeks and is conducted in a single-centre     (Isala Clinics, Zwolle). If non-inferiority is established superiority analyses are     performed.   "
127126|NCT01621087|"     The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a     cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction.     However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct     from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973)     was a randomized controlled secondary CHD prevention trial testing whether selectively     increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A     full analysis of mortality outcomes has not been published. The investigators recovered the     original SDHS dataset, which included detailed longitudinal dietary, smoking and coded     mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD     mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also     permitted the first complete meta-analysis of LA intervention trials on mortality outcomes.      Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD     mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed     mortality differences.   "
127110|NCT01621295|"     Communication is an important component of comprehensive cancer care impacting patient     satisfaction, adherence, and quality of life. The wide array of issues addressed in cancer     clinical interactions makes communicating about a broad range of topics (including quality of     life, communication, symptom control, complementary/alternative therapies, costs, treatment     burden, prognosis, anxiety, side-effects, sexual function, palliative care options, etc.)     especially interesting and potentially challenging. Some of these topics may not be routinely     addressed in the clinical interaction or may require consultative support from other members     of the comprehensive cancer care team. One frequently overlooked critical element in research     on communication between cancer clinicians, their patients, and their primary care clinicians     is describing real-time consultations between patients and their clinicians. These     interactions provide rich material for assessing key psycho-social dynamics and identifying     issues that patients find important in their care. In order to devise systems of care that     optimize the patient experience, it is critical that clinicians and researchers understand,     appreciate, and systematically characterize the richness and complexity of the     decision-making process in routine cancer consultations between cancer patients and their     treating clinicians. This study seeks to assess the patient experience in cancer care by     observing patients and their physicians in their clinical interactions and following them for     several months to see how their care went. By describing in-depth the conversations and     experiences of patients in these clinical interactions, this study will lay the foundation     for practice-based interventions to optimize patients' interactions with their cancer care     teams.   "
127111|NCT01621282|"     Running successful journal club is of the important goals for postgraduate education.In this     study, the effect of a 6-month interactive educational course on journal clubs of Mashhad     Dental school was observed using a valid and reliable checklist(r=0.74). Data will be     evaluated and compared using spss software by t-test.   "
127112|NCT01621269|"     Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12     months   "
127113|NCT01621256|"     The purpose of this study is to determine whether ancrod is effective and safe in the     treatment of sudden sensorineural hearing loss (SSHL).   "
127114|NCT01621243|"     People with primary metastatic pancreatic cancer will be treated with nab-paclitaxel and     gemcitabine in combination with an investigational agent called necuparanib (M402). It is     made from heparin, which is a well known blood thinner. Blood thinners have been shown in     prior animal and human studies to have anti-cancer effects. Necuparanib has been     re-engineered from heparin to have much lower blood thinning activity while keeping the     anti-tumor activity. The investigators are testing whether necuparanib administered in     combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and     gemcitabine.   "
127115|NCT01621230|"     The aim of this study is to measure the effects of bupivacaine administered via epidural     catheters on indices of motor blockade ascertained during the second stage of labor. This is     a randomized, double-blind, controlled trial designed to address the primary research     question: Does bupivacaine lengthen the second stage of labor? The secondary research     question is: Is there other evidence of motor blockade attributable to bupivacaine during the     second stage of labor?      The investigators know from prior studies that the length of the second stage in nulliparous     women delivered at Parkland Hospital without epidural analgesia is 28 minutes. The     investigators hypothesize in this now proposed study that epidural analgesia with bupivacaine     will significantly increase this baseline from 28 minutes to 37 minutes or more (a 33%     increase) thus implicating motor blockade. Baseline data for the Bromage and Breen scores     during the second stage as well as the uterine contractility data are not available as these     indices of motor blockade have not here-to-fore been studied in this context.      Currently at Parkland Hospital, 82% of nulliparous women undergoing induction of labor at     term receive continuous epidural infusions with bupivacaine during the first and second     stages of labor. Such women will be identified when admitted for scheduled inductions at     Parkland. After informed consent is obtained standard management of labor induction will be     provided. Those consented women reaching 8 cm cervical dilation will be randomized. Group I     will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10     cm dilation) and Group II will receive only fentanyl infusion via epidural catheter (see     study procedure below). Both the patient and the caregiver will be blinded as to whether the     patient is in the bupivacaine plus fentanyl arm or the fentanyl only arm. To detect a 33%     increase (from 28 minutes to 37 minutes) in the primary outcome the investigators need a     total of 310 women enrolled in the study (or 155 per arm). Assuming a 30% consent rate and     given that approximately 1000 women meet the inclusion criteria each year at Parkland, the     investigators project that this study could be completed in 12 months.   "
127116|NCT01621217|"     -  To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and          mitomycin C when given together with the antibody cetuximab in patients with locally          advanced cancer in the anal region        -  To evaluate acute toxicity        -  To evaluate late toxicity        -  To evaluate response rate        -  To evaluate recurrence free survival        -  To evaluate overall survival   "
127117|NCT01621204|"     This is a study to investigate if eltrombopag can be used instead of Intravenous Immune     Globulin (IVIG) in patients with ITP, to adequately raise their platelet count when they     undergo minor or major surgery. Eltrombopag is a daily, oral pill approved for treatment of     ITP. IVIG is a blood product frequently used to treat ITP. Patients with ITP who need surgery     have to get treatment to increase their platelet count. IVIG is commonly used for this     purpose but eltrombopag may be more effective and convenient for patients.   "
127118|NCT01621191|"     The purpose of the study is to assess the safety and efficacy of duloxetine in participants     with fibromyalgia at long-term use.   "
127119|NCT01621178|"     The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide     compared to insulin glargine in the treatment of participants with type 2 diabetes and     moderate or severe chronic kidney disease.   "
127120|NCT01621165|"     Mania has been considered to be, in part, a hyperadrenergic state. One focus of treatment of     mania involves directly targeting this hyperexcitable state by reducing arousal with     antiadrenergic agents. This can be achieved by decreasing norepinephrine release by     stimulating presynaptic inhibitory receptors. Prazosin, FDA approved for the treatment of     high blood pressure works in part by blocking postsynaptic alpha-adrenergic receptors.     Prazosin has been found to be clinically useful for the treatment of Post Traumatic Stress     Disorder. It is reasonable, therefore, to anticipate that prazosin might be helpful in the     treatment of mania.   "
127137|NCT01620944|"     The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency     virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48     of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one     additional drug [Lamivudine (3TC) 300 mg daily] or 2 additional drugs     [Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily].   "
127175|NCT01620437|"     This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence     of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.   "
127127|NCT01621074|"     During endurance exercise in the heavy and severe intensity domains, the rate at which     metabolites that have been associated with the fatigue process (e.g. Pi, ADP, H, and     extracellular K) accumulate increases. possibly leading to exercise cessation. Sodium     bicarbonate, as a nutritional supplement, has gained attention over the past decades, because     it might delay of offset fatigue. To date, there is a controversial discussion about which     delivery mode (amount and frequency) might be best in optimizing endurance performance. Since     the high ion load consequent to multiple ingestions might increase plasma volume, and     consequently decrease bicarbonate concentrations, single acute ingestion could be more     beneficial. However, in multi-day competitions or tournaments it might be necessary to use     the supplement on a daily basis. Here, the investigators aim at investigating the effects of     single dose or multiple dose (on five consecutive days) administration of bicarbonate vs.     placebo increases endurance performance and acid-base homeostasis in trained male endurance     athletes.   "
127128|NCT01621061|"     High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term     residents at altitudes >2500 m, is characterized by dyspnea, hypoxemia, impaired exercise     performance and hypertension in the pulmonary circulation. Whether sleep related breathing     disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in     highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the     current study will investigate whether highlanders with high altitude pulmonary hypertension     have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.   "
127129|NCT01621048|"     Radiotherapy plays an important role in the curative treatment of head and neck cancer. This     treatment however is associated with significant acute and late toxicity with xerostomia and     dysphagia severely implicating the patient's quality of life. With highly conformal     radiotherapy techniques it is possible to decrease de dose to the organs at risk while     maintaining adequate doses to the tumour. In order to adequately register the effect of these     techniques it is imperative to obtain standardized information on the acute and late     treatment effects. With this study the investigators want to evaluate this toxicity using     standardized and validated questionnaires during follow-up. This data will then be correlated     to the doses delivered to the specific organs at risk.   "
127130|NCT01621035|"     The purpose of the present study is to evaluate the validity of 2 objective measures of     physical activity among older adults. In addition, the investigators will examine the     influence of functionality, walking aids, walking speed and step length on the accuracy.   "
127133|NCT01620996|"     Study Purpose and Design      The goal of this study is to improve CVD risk in a primary care adult population, with the     following primary objectives        1. To improve management of global cardiovascular risk of patients within two primary care          practices, thereby improving their overall cardiac health.        2. To increase patient compliance with lifestyle aimed at pharmaceutical interventions          aimed at decreasing global cardiovascular risk.      Secondary objectives of the study are:        1. To examine the utility of a process to improve the management of global cardiovascular          risk of patients within two primary care practices.        2. To explore the utility of a process that links primary care practices with existing          community resources in order to manage cardiac risk factors better among individuals          within those primary care practices.        3. To determine the economic impact of a global risk assessment and management process          within a primary care setting.   "
127134|NCT01620983|"     Patients undergoing knee replacement surgery and who have high levels of pain catastrophizing     are at risk for poor outcome. The clinical trial is designed to determine if a pain coping     skills training intervention delivered by physical therapists and supervised by psychologists     is more effective at reducing pain and improving function and is more cost effective than     arthritis education or usual care.   "
127135|NCT01620970|"     Salvage chemotherapy for advanced urothelial cancer (UC) yields suboptimal response rates of     15-40%, a median progression-free survival of 2-4 months and a median overall survival of 6     months. A rationale for targeting angiogenesis in UC is supported by preclinical evidences     and early signals of clinical activity of anti-VEGF TKI as demonstrated by our group with the     use of pazopanib.      Despite this activity, progression inevitably occurs and mechanisms determining resistance to     conventional anti-angiogenic agents are under investigation.      PF-03446962 (Pfizer Inc) is a novel fully human monoclonal antibody (mAb) against ALK1 with     dose-dependent antiangiogenic activity as demonstrated in nonclinical studies in a chimera     mouse model bearing human tumor xenograft. The investigators suggest that PF-03446962 may     increase current results for patients with advanced urothelial cancer failing upfront     chemotherapy due to its mechanisms of action. Due to the lack of reliable and reproducible     predictors of response as well as of imaging tools to assess tumor response, the trial will     provide incorporation of 18FDG-PET/CT and contrast-enhanced ultrasound to stage and evaluate     response of urothelial cancers, together with standard imaging modalities (RECIST criteria).     Blood and tissue samples will be collected for translational purposes.   "
127136|NCT01620957|"     Several studies in healthy volunteers have suggested that the synchronized functional     connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and     when required, a switch in the activity between the DMN and other networks involved in     specific congnitive functions, would occur. This interaction permit to make the hypothesis,     that baseline brain activity is likely to shape our ongoing  stream of consciousness  and     could correlate with conscious perception. The investigators hypothesized that DMN     connectivity strength would be related to the level of consciousness of brain-damaged     patients. The investigators will follow severely brain-injured patient in coma. Clinical     examination using standardized behavioural scales: FOUR score (Full Outline of     UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI     (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30     (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state     between 30 and 60 days, an additional clinical and brain imaging assessment will be performed     to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will     be performed in patients by a senior anaesthesiologist throughout the experiment.   "
127176|NCT01620424|"     This trial is conducted in Japan. The aim of this trial is to investigate the     pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and     biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.   "
127139|NCT01620918|"     -  Baseline:             -  Standard preparation of the osteotomy             -  Placement of 2 dental implants             -  On each implant one of both types of healing abutments is placed             -  Suturing             -  Standardized radiography to measure bone-levels at baseline             -  Digital impression of the surrounding gingiva with an intra-oral scanner (a               non-invasive method) to measure the baseline level of the gingiva        -  2 weeks after Baseline:           o Removal of the sutures        -  4 weeks after Baseline:             -  A 2nd digital impression of the soft tissue with an intra-oral scanner             -  Collecting crevicular fluid by placing paperpoints in the provided apertures in the               healing abutments for 60 seconds without bleeding.             -  Measuring of the pocket depth in the provided apertures in the healing abutments               with an automated probe.             -  Removal of the Healing Abutment with the attached soft tissue en-bloque.             -  Placement of a new, regular, Encode Healing Abutment.        -  10 weeks after Baseline:             -  Start of standard prosthetic procedure. In this study we expect that the soft               tissue attachment (i.e. the gingival attachment) will be stronger and earlier               achieved at the nano-structured healing abutments than at the normal, uncoated               healing abutments. This would lead to a more stable soft tissue complex on the long               rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger               attachment would mean a stronger barrier against micro-organisms and might               influence the occurrence of peri-implantitis.   "
127140|NCT01620905|"     Cervical spine manipulation has been shown to be helpful for some patients with neck pain.     This study sought to determine factors which were predictive of which patients with neck pain     would benefit from manipulation.   "
127179|NCT01620385|"     The primary purpose of the research is to study how individuals who wear cochlear implants     process sounds in noisy environments and also whether newly designed programs can help     improve the communicative ability of cochlear implant patients in noisy situations.   "
127141|NCT01620892|"     The study seeks to evaluate the condition of patients 5 years after having undergone partial     knee replacement for localized osteoarthritis of the knee. Participating patients will     voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after     surgery. The aims of the study are to describe the survivorship of the prostheses and the     clinical results of patients, and to elucidate and describe the natural history disease of     the untreated knee joint compartments after a partial replacement. Patients who were operated     by the principal investigator 5 years previously will be invited to participate. The study is     observational in nature; there is no element of experimentation or test of an intervention.   "
127142|NCT01620866|"     The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR),     an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning,     quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.   "
127143|NCT01620853|"     The purpose of the study is the identification of chromosomal aberrations in non-small cell     lung cancer (NSCLC) .      The imaging system is intended for diagnostic use as an aid to the pathologist in the     detection, counting and classifying ALK FISH stained lung samples.   "
127144|NCT01620840|"     Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different     formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is     approved as adjunctive therapy in epilepsy patients with partial onset seizures with or     without secondary generalization. The i.v. solution is used in patients in which oral     administration is not possible or adequate. Bioequivalence with oral tablets and safety could     be demonstrated in healthy volunteers and in patients switched from tablets to Lacosamide     i.v. solution. A recently published study demonstrates the feasibility of single loading     doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect systematically     data on the safety, tolerability and administration procedures when Lacosmide i.v. is used in     routine daily clinical practice, mainly in hospitals. These data will help treating     physicians to optimize the use of Lacosamide i.v. in clinical routine.   "
127145|NCT01620827|"     This study is being conducted to evaluate the hypothesis that study subjects will be more     responsive to follow-up phone calls made from personal cell phone numbers than from hospital     landline numbers. To evaluate this, study subjects previously enrolled in a cardiac biomarker     study (the Early Identification of Acute Coronary Syndrome study) were randomized to receive     their follow-up phone calls (the calls associated with the Early ID study occur at 30 days     and 1 year after initial enrollment) from either a hospital office landline or from the     personal cell phones of the research assistants making these calls. This was done as a 1:1     randomization. The number of call attempts required to reach the study subjects were recorded     as the calls were made and the date of successful follow-up was recorded once contact was     made.   "
127146|NCT01620814|"     Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening     before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED     PROSPECTİVE TRİAL Objective. Comparison with one another and with control group of vaginal     dinoprostol and misoprostol with for the purpose of cervical ripening before diagnostic     hysteroscopy.      Population: It was planned for performing to 95 women who appealed to gynecology polyclinic     and will be performed diagnostic hysteroscopy.      Methods: Eighty-six women who will be performed diagnostic hysteroscopy assigned as randomize     to three groups. It was planned that none procedure will be applied to group 1 for cervical     ripening, vaginal misoprostol and vaginal dinoprostone will be practiced to Groups 2 and 3,     respectively.   "
127147|NCT01620801|"     Hemophilia B is a bleeding disease in males due to very low levels of coagulation factor IX     (FIX) in the blood. The current treatment is intravenous injection of FIX clotting factor     concentrates, in response to bleeding. This study will focus on the severe, most common type     of hemophilia B. This study plans to use a virus called adeno-associated virus (AAV), which     in nature causes no disease, and can be engineered to deliver the human FIX gene (AAV8-hFIX19     vector) to liver cells, where FIX is normally made. This study will use the AAV8-hFIX19     vector.   "
127148|NCT01620788|"     The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan     50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.   "
127964|NCT01610115|"     To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine     aminotransferase (ALT) levels during pregnancy   "
127149|NCT01620775|"     This study is designed to assess:      Hypothesis #1: That there is a significant central pain component in a distinct subset of     patients diagnosed with knee osteoarthritis(KOA), Chronic low back pain(CLBP), painful     diabetic neuropathy(PDN.)      Hypothesis # 2: To establish a reliable strategy for differentiation of central pain     predominant from peripheral pain predominant knee osteoarthritis(KOA), chronic low back     pain(CLBP)and peripheral diabetic neuropathy(PDN) patients using clinical features,     experimental pain testing and magnetic resonance(MR) Spectroscopy.   "
127150|NCT01620762|"     The purpose of this study is to compare the treatment effect of two treatment regimens of     Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue     medication usage and Quality of Life.   "
127151|NCT01620749|"     The purpose of this study is to investigate the safety and potential effectiveness of the     imaging compound 18F MEL050 for finding sites of melanoma.   "
127152|NCT01620736|"     This is a study of the effect of raltegravir on human T-cell leukemia virus type 1 (HTLV-1)     viral load in asymptomatic patients. The study will enroll 14 subjects for a period of 2     months of treatment and 1 month of followup. The study will assess the effect of raltegravir     on virus load in peripheral blood lymphocytes, level of virus gene expression, and sites of     viral integration.   "
127153|NCT01620723|"     The purpose of this study is to evaluate if the developed theory and evidence based programme     has a positive effect on mother's breastfeeding self efficacy, establishing an effective     breastfeeding and breastfeeding duration after short time hospitalization.   "
127154|NCT01620710|"     This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with     higher daily doses and shorter total treatment time compared to standard fractionation) of     the prostate bed with or without the pelvic lymph nodes.   "
127358|NCT01618058|"     The purpose of this trial is to determine if exposure to ARV-containing investigational     products in IPM clinical trials will impact the natural history of HIV infection as measured     by the virologic, immunologic and clinical outcomes of participants who become HIV-positive     during the IPM 027 trial.   "
127155|NCT01620697|"     While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value     as independent parameter in predicting postoperative complications after colorectal resection     remains poorly investigated.      The investigators want to test the value of perirenal fat as surrogate of visceral obesity as     risk factor for morbidity in colorectal surgery and to compare it to the effect of Body mass     index (BMI) and Waist- Hip ratio (WHR).   "
127156|NCT01620684|"     This project will examine whether short-term (over a 12-hour period) pharmacological lowering     of the stress hormone 'cortisol' improves the nervous system response to food intake in     overweight or obese individuals who have metabolic syndrome.      The investigators know from our previous research that overweight/obese persons who are     insulin resistant, have a blunted sympathetic nervous response to carbohydrate ingestion.     This means that they are less able to dissipate energy from caloric intake, which would     favour the maintenance of the obese state. Cortisol adversely impacts on insulin action and     transport into the brain and cortisol levels are often elevated in persons with central     (abdominal) obesity.      A randomized, double-blind, placebo controlled, cross-over design will be used to compare the     effects of overnight treatment with metyrapone (15 mg/kg at midnight and 15 mg/kg at 6 am)     versus placebo on sympathetic nervous system activity in response to a standard 75-g oral     sugar (glucose) tolerance test. A 2 week washout will separate treatments.      Metyrapone is a drug that reversibly inhibits the enzyme 11beta-hydroxylase, and therefore     the production of cortisol. It is used clinically to test the activity of the adrenal gland     (the key site of cortisol production) and the pituitary gland. The investigators anticipate     that at the dosage used, it will lower blood cortisol concentration by 44 to 64% during the     experimental morning.      The study protocol comprises two screening visits and two experimental mornings. Key     procedures will include:        -  Assessment of insulin action (sensitivity) using the gold standard 'clamp' method.        -  Measurement of sympathetic nervous system activity by both biochemical methods (isotope          dilution which provides a measure of the apparent rate of release of 'noradrenaline'-the          key neurotransmitter in the sympathetic nervous system) and direct intra-neuronal nerve          recordings from the peroneal nerve in the lower leg.        -  Indirect calorimetry to assess resting metabolic rate and the response to sugar          ingestion.        -  DEXA scan to quantify fat and lean mass.        -  Assessment of arterial elasticity and calf blood flow by non-invasive methods.        -  A standard 75g oral sugar tolerance test.      The results will provide important new information regarding the role of cortisol on nervous     system function in overweight/obese individuals.   "
127157|NCT01620671|"     The concept of enhanced recovery after surgery has become increasingly popular in elective     abdominal surgeries. Yet, the role of this concept has not been described in emergency     procedures. Therefore, this study aimed to investigate the feasibility of fast-track surgery     in patients with perforated peptic ulcer.   "
127158|NCT01620658|"     The primary objective of the present trial is to compare the radiation attenuation provided     by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection     (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days     of fluoroscopy guided cardiology interventions. The second objective is to compare the     operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared     to the standard fabric caps.   "
127159|NCT01620645|"     The UK Medical Research Council (MRC) together with the Association of British Pharmaceutical     Industries (ABPI) have recently funded a program designed to foster collaboration between     academic COPD researchers and the pharmaceutical industry in the UK, with the aim of     developing and furthering our research capacity and expertise for the benefit of patients     living with this prevalent and disabling condition. This builds on the strong international     track record of COPD research in the UK. The program is divided into four work packages     (WP1-4), each with specific aims. WP1 will collate and establish data from patient cohorts     and share this information through the development of knowledge management platforms. WP2     will specifically assess how airway micro-organisms impact on COPD and how the effects of     bacteria and viruses may be modified. WP3 is concerned with tissue injury and repair which     are fundamental processes in the development of COPD. WP4 will examine in detail the     potential for improving patient outcomes by targeting the skeletal muscle dysfunction that     can profoundly affect exercise capacity.   "
127160|NCT01620632|"     The purpose of this research study is to collect data on the technical aspects of     Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients     with Roux-en-Y gastric bypass surgery.   "
127161|NCT01620619|"     The null hypothesis is that there is no statistical difference between the two treatment     groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion     repair with rotator interval closure will have lower quality of life and less external     rotation compared to patients who undergo a Bankart lesion repair alone. No difference will     be observed for recurrence rate between the two treatment groups   "
127162|NCT01620606|"     Functional abdominal pain (FAP) is a common complaint of childhood, associated with     considerable health care costs, disruption of normal activity, emotional distress, and     long-term health effects. The study will test a treatment approach which, if successful,     would substantially change the treatment for FAP and potentially for a wide range of     childhood medical problems where parental responses to symptoms contribute to these adverse     effects. The study would also provide a model which would be much more accessible than     traditional face-to-face therapies to a broader range of families in need than are currently     served.   "
127163|NCT01620593|"     Prostate cancer is the most common non-cutaneous cancer in men. Patients with recurrent or     metastatic prostate cancer are treated with androgen-deprivation therapy, often termed     castration therapy. While the short and medium term benefits of castration are clear in     relation to therapeutic efficacy in patients with prostate cancer, it is now appreciated that     the resulting hypogonadism associated with castration is responsible for adverse consequences     or metabolic syndrome that include increase in body mass index (BMI) and fat mass,     hyperinsulinemia and insulin resistance, hyperlipidemia, reduced lean body mass (LBM) and     muscle strength, osteoporosis, sexual dysfunction, poor quality of life and higher     cardiovascular mortality. Lower testosterone levels in men independently predict the     development of metabolic syndrome. Low testosterone levels in men are associated with insulin     resistance and diabetes. Metformin is commonly prescribed for the treatment of type II     diabetes because it lowers both glucose and insulin levels. Studies show preliminary evidence     that metformin might have both antineoplastic and chemopreventative activity. Castration     therapy decreases insulin sensitivity, adversely alters lipid profiles and results in weight     gain, and it may be associated with a greater incidence of diabetes and cardiovascular     disease. Little is known about the optimal strategy to mitigate the adverse metabolic effects     of castration in men with prostate cancer. The rationale for using metformin in castrated men     with advanced prostate cancer stems from the observation that castration therapy is     associated with the metabolic syndrome, hyperinsulinemia and insulin resistance. Furthermore,     reports that hyperinsulinemia stimulates insulin receptor expression on prostate cancer     leading to tumor growth and development of castrate resistant prostate cancer suggest     metformin through its activation of the AMPK-LKBI pathway reduces liver gluconeogenesis     secondarily decreasing insulin levels may circumvent tumor growth and resistance to     castration therapy. More importantly, evidence that metformin inhibits the mTOR pathway     implicates an added therapeutic benefit as an anti-cancer agent.   "
127164|NCT01620580|"     Self-management intervention may decrease symptom burden and improve functioning over time.   "
127415|NCT01617317|"     Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent     plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe     H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of     stay in ICU and hospital.   "
127165|NCT01620567|"     Cognitive impairment is also a major risk factor for development of dementia later in life.     Findings from the investigators studies suggest that the carotenoids, lutein and zeaxanthin     may be important in cognitive function in the elderly. Avocados are a source of these     carotenoids. The investigators study evaluates long-term avocado intervention as a treatment     strategy for age-related cognitive impairment which could possibly prevent the onset of     dementia. The investigators have also shown that lutein supplementation significantly     improved verbal fluency scores in healthy older women. Based on these findings, the next     logical step will be to investigate the ability of lutein and zeaxanthin contained in     avocados to influence cognitive function in older adults. The investigators hypothesize that     there will be a significant increase in cognitive function measures in older adults provided     with meals containing 1 avocado/day at the end of 6 months, while no significant improvements     will be observed in older adults given daily meals containing chickpeas and/or potatoes.      The proposed study is designed as a randomized, placebo controlled trial that tests the     effects of 6 month supplementation with 1 avocado/day on cognitive function in older adults.     Secondary analyses will determine whether baseline macular pigment (lutein in retina which     canbe measured non invasivley) density predicts relative effectiveness of the intervention on     cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and     inflammation.   "
127166|NCT01620554|"     Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5     parallel groups (dose-range).   "
127167|NCT01620541|"     End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain,     dysfunction, and reduced quality of life. Many patients with ESAA have difficulty walking for     even 100 feet or up a single flight of stairs. Patients seeking surgery for ESAA have two     primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty     (i.e., ankle replacement). Few studies have directly compared the effectiveness of these two     procedures, and no randomized controlled trials (RCTs) have been performed.      The investigators will compare the following in subjects undergoing ankle arthrodesis and     ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual basis     up to ten years.        1. Overall physical function and ankle specific function        2. Ankle pain intensity and interference with activities        3. Activity levels        4. Overall general health        5. Post-surgical complication rates      The investigators will also identify prognostic factors that are predictive of higher     physical function, ankle specific function, reduced pain, improved general health, and     overall patient satisfaction.   "
127168|NCT01620528|"     A randomized study evaluating the safety and efficacy of elagolix in the management of     moderate to severe endometriosis-associated pain in adult premenopausal female subjects.   "
127169|NCT01620515|"     This study is designed to evaluate the safety and efficacy of a single injection of NX-1207     for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients     currently undergoing active surveillance. Study participants currently on active surveillance     will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5     mg or 15 mg) followed by active surveillance or to no treatment (continued active     surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate     biopsy.   "
127170|NCT01620502|"     The first part is a double-blind placebo-controlled trial to identify the effects of omega-3     polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part     is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients     with IFN-induced depression.   "
127171|NCT01620489|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to investigate the efficacy and safety of liraglutide in subjects with type 2     diabetes and moderate renal impairment.      The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin     regimen.   "
127172|NCT01620476|"     This trial is conducted in Japan. The aim of this trial is to assess the safety and     tolerability of liraglutide in healthy Japanese male subjects.   "
127173|NCT01620463|"     This trial is conducted in Japan. The aim of this trial is to assess the safety and     tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.   "
127177|NCT01620411|"     This study aims to investigate the relative effectiveness of two different pain management     plans for injuries sustained while active duty in the military. One arm of the study has     subjects undergo standard comprehensive medical management, while the other adds the     placement of a spinal cord stimulator, a common procedure for the alleviation of pain.   "
127178|NCT01620398|"     There are no studies exploring the benefits of a diet composed of typical Brazilian food in     the secondary prevention of cardiovascular diseases. Randomized studies show that the     Mediterranean diet is beneficial for patients with established cardiovascular disease or in     risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of     main references for dietary guidelines for treatment and prevention of CVD in Brazil and the     world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are     not widely available, may be expensive or are not part of population eating habits. So, the     prescription of the Mediterranean diet intervention for cardiovascular disease to the     Brazilian population may not be feasible, leading to a low adherence. In this context,     patients with established CVD have a low compliance to nutritional prescription. The BALANCE     Program, considers 3 concepts: a) A dietary prescription guided by nutritional content     recommendations from the Brazilian national guidelines; b) A nutritional education program     based on fun, playful strategies and suggestions of affordable foods; and c) Intensive     follow-up through one-on-one visits, group sessions, and phone calls. This is the first     proposal to use these concepts concurrently with the objective to increase adherence of     secondary prevention patients to the diet proposed by the guidelines. Therefore, this trial     will investigate the effects of the Program on reducing cardiovascular events - such as     cardiac arrest, acute myocardial infarction (AMI), stroke, myocardial revascularization,     amputation for peripheral arterial disease, and hospitalization for unstable angina - or     death in patients with established CVD. Moreover, it will evaluate the effects of the dietary     program on reducing CV factors, such as BMI, waist circumference,   "
127180|NCT01620372|"     The FCCSS is a multicentric national large-scale collaborative population-based study of     children treated for a solid tumor before 2000 in France and before the age of 19 years.      The study is concerned by improving knowledge about the long-term effects caused by cancer     and its treatments including adverse health and social outcomes.      The main reason of the FCCSS is to estimate the risk of adverse health and social outcomes     that may occur after a cancer treatment and to prevent them by providing adapted follow-up     care.      The cohort will be followed for up to 20 years from 2011.   "
127181|NCT01620359|"     The goal of this prospective, non-randomized, single-arm, multi site, international study is     to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the     ablation of breast cancer and of MRI.      The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in     a treatable and device accessible location.   "
127182|NCT01620346|"     The objective of this study was to evaluate the advanced maternal age as a rationale for     performing intracytoplasmic morphologically selected sperm injection (IMSI).      This prospective randomized study included couples undergoing intracytoplasmic sperm     injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly     allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33).     The groups were compared with regard to fertilization rate, percentage of high-quality     embryos, implantation, pregnancy and miscarriage rates.   "
127183|NCT01620333|"     This trial is conducted in Japan. The aim of this trial is to investigate the     pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70     (NN-X14Mix70) in Japanese healthy volunteers.   "
127184|NCT01620320|"     Left main stenosis use to be treated by bypass but with the improvement of angioplasty     techniques, an increasing number of patients are submit to left main coronary angioplasty.     Consequences of left main intra stent stenosis can be disastrous yet, for the moment, no     precise recommendation concerning the follow up of these patients exist. The investigators     ought to determine if stress echocardiography can predict left main intra stent stenosis as     well (non inferiorly)as control angiography that use to be done.   "
127185|NCT01620307|"     Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells     infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking     activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe     H1N1 pneumonia with respiratory failure, this study was conducted.   "
127186|NCT01620294|"     After open colorectal surgery the surgical site infection (SSI) is very high among abdominal     surgeries. The goal of the investigators randomized, prospective, multicentric,     internet-based study is to compare rate of SSI after surgery of colon and rectum by using     triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are     involved in this study. Two arms are separated by computer randomization at abdominal wall     closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus).     Triclosan is an antiseptic material which the investigators hope will provide better local     infection control at the site with reducing the risk of bacterial colonisation.   "
127187|NCT01620281|"     This pilot study is designed to evaluate the efficacy of the no!no!Back continuous passive     motion device in relieving of mild to moderate non-specific low back pain.   "
127188|NCT01620268|"     This study will evaluate the clinical efficacy and safety of a combination of leflunomide and     orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the     purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney transplant     loss from viral damage, acute rejection or both.   "
127189|NCT01620255|"     To determine the dose or doses of PF-00547659 that will be the most effective to improve or     halt the disease symptoms in patients with moderate to severe ulcerative colitis.   "
127190|NCT01620242|"     This is a multi-center phase II study assessing whether cabazitaxel could be efficient for     treatment of recurrent or metastatic head and neck cancer after failure of cisplatin,     cetuximab and taxanes.   "
127191|NCT01620229|"     This phase I/II trial studies the side effects and best way to give brentuximab vedotin and     to see how well it works after donor stem cell transplant in treating patients with     hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block     cancer growth in different ways. Some block the ability of cancer to grow and spread. Others     find cancer cells and help kill them or carry cancer-killing substances to them. Monoclonal     antibodies may kill cancer cells that are left after donor stem cell transplant.   "
127202|NCT01620086|"     This study compares the efficacy of low and high frequency repetitive transcranial magnetic     stimulation (rTMS) as a means of treating subjects with schizophrenia. Magnetic pulses     delivered over the scalp cause brain activity. This activity has been shown to help decrease     the intensity and frequency of auditory hallucinations (AH) in schizophrenia. The     investigators will compare whether low or high frequencies work best. The investigators will     also examine what changes occur in the brain that are related to improvement.   "
127192|NCT01620216|"     This phase II trial studies how well targeted therapy works in treating patients with acute     lymphoblastic leukemia or acute myelogenous leukemia that has come back after a period of     improvement or does not respond to treatment. Testing patients' blood or bone marrow to find     out if their type of cancer may be sensitive to a specific drug may help doctors choose more     effective treatments. Dasatinib, nilotinib, sunitinib malate, sorafenib tosylate, and     ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth. Giving targeted therapy based on cancer type may be an effective     treatment for acute lymphoblastic leukemia or acute myelogenous leukemia.   "
127193|NCT01620203|"     Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can     have considerable effects on neurodevelopmental outcome.      The investigators showed that preterm infants with severe ICH have decreased cerebral     oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of     decreased cerebral oxygenation in preterm infants and the effects on cerebral function are     unknown.      This longitudinal observation study will evaluate physiologic parameters to determine trends     in cerebral oxygenation and function in preterm infants with ICH in comparison to infants     without ICH.   "
127194|NCT01620190|"     This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle     formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat     patients with breast cancer. Doctors want to know if Abraxane is safe and effective in     treating patients with lung cancer that has spread to other places in the body and usually     cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor     (EGFR) mutations.   "
129055|NCT01595880|"     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of     gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component     administered alone in healthy male volunteers.   "
127195|NCT01620177|"     The purpose of this study is to expand understanding of the effects of cannabis on driving     performance with and without the presence of low levels of alcohol.      This project will involve the development a of a protocol and driving environment that is     sensitive to the effects of cannabis on driving performance by building on prior driving     situations used previously for testing the effects of alcohol on driving.   "
127196|NCT01620164|"     Parkinson's disease is characterized by motor deficits, improved by dopaminergic intakes.     Besides motor symptoms, visual troubles are observed in patients with Parkinson's disease, in     particular spatial orientation problems including 3D vision. However, although these visual     disturbances are commonly reported by the patients and their family in our clinical     experience, they have not been the subject of specific clinical studies yet.      Parkinsonian patients report deficits in 3D vision leading to a loss of visuomotor ability,     locomotor functions and to falls. Despite these frequent complaints, little is known about 3D     vision in Parkinson's disease. The investigators want in this project to precisely estimate     3D deficits in parkinsonian patients by assessing their psychophysical performances in 3D     vision tasks to compare to age matched control subjects' performances.   "
127197|NCT01620151|"     Primary: To compare the post-operative pain in patients with neck extension and without neck     extension.      Secondary: To determine the benefit of neck exposure and peri-operative complications, which     include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and     hypocalcaemia in both groups.      Hypothesis: Patients who undergoing thyroidectomy without neck extension will have less     post-operative pain and there are no significant difference of post-operation complications     between both groups.   "
127198|NCT01620138|"     There are no available medical treatment options for patients with non-functioning pituitary     adenomas (NFPA) or with resistant prolactinomas to dopamine agonists (DA) who are not cured     by surgery. The study of the receptors by quantitative messenger ribonucleic acid (mRNA)     expression levels and immunohistochemistry analysis might end with a better understanding of     these tumors. Besides that, it will be assessed the in vitro and in vivo responses to     pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA). These responses will be     compared with the receptor expressions which may be a tool as a predicting element of the     response to these compounds.   "
127199|NCT01620125|"     Recent data suggest that the trillions of bacteria in the investigators gastrointestinal     tracts (gut microbiota) can function as an environmental factor that modulates the amount of     body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant     to developing diet-induced obesity and have lower fasting insulin and glucose and improved     glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in     fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by     reducing lipid absorption and inflammatory status. However, there are no studies to the     investigators knowledge that address whether probiotic supplementation improves glucose     metabolism in type 2 diabetes patients.   "
127200|NCT01620112|"     The purpose of this study is to determine whether different clonidine concentration on     axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the     sensory and motor block onset time and duration, postoperative analgesia duration,     postoperative pain intensity   "
127201|NCT01620099|"     Asthma is an inflammatory disease affecting the whole respiratory system, from central to     peripheral airways. Anti-inflammatory treatment with inhaled corticosteroids (ICS), with or     without long-acting β2-adrenoceptor agonists (LABA), is the cornerstone of asthma management     [GINA Guideline - available at www.ginasthma.com]. Nevertheless, a considerable subset of     asthmatic patients neither benefits from ICS nor gain optimal asthma control even with     ICS/LABA combinations.      The involvement of the distal lung, i.e. the peripheral membranous bronchioles < 2 mm in     diameter (so-called small airways), in the pathogenesis of asthma has been extensively     investigated and its significance debated. However, whether specifically targeting distal     lung abnormalities can lead to further clinical benefit is still an open question. In this     context, interest has been raised by hydrofluoroalkane (HFA) pressurised metered-dose     inhalers, which can deliver compounds with a mass median aerodynamic diameter that is     significantly smaller than other available devices, leading to increase peripheral airways     drug deposition.      Up to 30% of asthmatic patients smoke, mirroring the rate found in the general population.     Several data document that smoking habit negatively affect corticosteroid efficacy in asthma.     In particular, asthmatic patients who smoke experience faster lung function decline,     increased frequency of exacerbations and reduced asthma control despite being regularly     treated. Several molecular mechanisms have been proposed to address the issue of reduced     corticosteroids responsiveness in smoker patients. However it has been never investigated     whether reduced corticosteroid responsiveness in asthmatic patients who smoke can be related     to more severe small airways involvement leading to impaired distribution or impaired     peripheral deposition of inhaled corticosteroids. If this is the case, asthmatic patients who     smoke might benefit from a pharmacological approach able to target and to reach small     airways.   "
127203|NCT01620073|"     The investigators hypothesize that home based HIV counseling and testing can increase male     partner uptake of HIV testing during pregnancy.      The investigators study aims through a randomized clinical trial to determine whether a     home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake     of HIV counseling and testing during pregnancy.   "
127204|NCT01620060|"     This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose     study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum,     autistic spectrum disorder, or other psychiatric disorders.   "
127205|NCT01620047|"     Major surgery involving the knee is often associated with severe postoperative pain.     Postoperative pain control remains a significant contributor to delayed recovery and length     of hospital stay. Approaches to minimize postoperative pain after surgery are a matter of     major concern due to the need for early mobilization, a crucial factor in good postoperative     rehabilitation. Femoral nerve blocks by either continuous infusion or single injection of     anesthetics provide an effective method for analgesia while minimizing the need for systemic     opioid therapy, reducing the opioid induced side effects, and facilitating early ambulation.     Administration of fentanyl has shown to be a highly effective method to control pain after     Total Knee Replacement (TKR). The investigators hypothesize that fentanyl infusions will     result in greater post-operative strength in the operative knee.   "
127206|NCT01620034|"     Stereotactic Body Radiotherapy (SBRT) has emerged as a new treatment option for peripherally     located lung tumours, offering very high rates of tumour eradication, with minimal side     effects. Even though this treatment option is being adopted in more and more cancer centres,     there is still no consensus about the optimal schedule for the radiation treatment. Generally     speaking, most lung SBRT schedules involve delivering 3-4 days of radiation. At the     Sunnybrook Odette Cancer Centre, the lung SBRT policy is to deliver 4 days of radiation over     11 days (each treatment given once very 3rd day). However, some centres deliver the same     treatment over 4 days in a row (each treatment given once daily over 4 days). There is no     evidence from the published literature to suggest that there is any difference in side     effects between delivering the SBRT over 4 days versus 11 days. To confirm this, the     investigators propose to conduct a comparative (randomized) study to compare these 2     approaches.   "
127207|NCT01620021|"     Hypotheses:      • A wearable sensor system can be used to accurately monitor three common gait parameters:     gait speed, stride length, and torso motion.      Objectives:      This study will examine the feasibility of using wearable sensors to monitor common gait     parameters: gait speed, stride length and torso motion. A wearable sensor system of 8     commercially available inertial measurement units (IMU) will be composed. These sensors will     work in unison to monitor the gait parameters.      Technical Objectives        -  Gather information on commercially available IMUs        -  Use computer software to monitor and record data from IMUs        -  Develop an algorithm that can monitor volunteer gait speed, stride length and torso          motion        -  Develop a graphical algorithm that compares healthy patient data to potential mild          traumatic brain injury (mTBI ) candidates        -  Determine if there is a potential for mTBI determination using the wearable sensors        -  Accurately validate the wearable sensor system to the gait parameters measured using a          Vicon motion analysis system   "
127208|NCT01620008|"     The purpose of this study is to determine if delaying cord clamping at the birth of term     infants effects the early brain development (myelin deposition)as determined by quantitative     MRI at 4 and 10 months and developmental testing at 4, 10 and 24 months. This study will help     to establish a scientific basis for the timing of cord clamping with reference to brain     development.   "
127209|NCT01619995|"     The goal of this project is to evaluate the applicability of non-invasive optical imaging for     the measurement of brain function during investigation of the lower urinary tract.   "
127210|NCT01619982|"     The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will     decrease the rate of cefazolin non-susceptible SSI's, in high risk population 2) to develop     better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing     cardiopulmonary bypass 3) to assess the barriers to vancomycin dosing peri-operatively 4) to     assess side effects and risks associated with peri-operative vancomycin administration. This     will allow us to improve patient care by better understanding the benefits or the risks of     peri-operative vancomycin administration and potentially decrease cefazolin-resistant     surgical site infections.      In addition, this study gives us the opportunity to evaluate cefazolin and vancomycin     pharmacokinetics on children on CPB.      The investigators will take blood samples from 20 patients. In 10 patients the investigators     will do Cefazolin pK analysis and in the other 10 the investigators will do pK Vancomycin     analysis. For the remainder of 292 patients, only prospective chart review will be done to     determine the incidence of SSI's.      This data will be compared with 936 controls who received only Cefazolin pre-operatively as     prophylaxis for SSI's.   "
127211|NCT01619969|"     This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate     the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with     Confirmed Dengue Fever.   "
127219|NCT01619865|"     This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging,     and measurement of response to treatment in patients with somatostatin receptor positive     tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care     which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high     resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in     diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those     patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as     anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used     to measure response to treatment. These studies will be obtained with the long term goal of     submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and     children.   "
127307|NCT01618721|"     The study seeks to characterize data obtained from patients with a variety of lung diseases     using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a     Doppler mode is placed on the chest wall and the unique software the investigators have     developed analyzes the signals reflected from within the lung. On the basis of of pilot     studies performed previously the investigators expect to receive different signals from     different diseases that will enable diagnosis of different lung diseases.   "
127212|NCT01619956|"     The osteotome sinus floor elevation (OSFE) technique has been proved to be a predictable     procedure for successful implant placement in posterior maxillae with limited bone height     under sinus. OSFE is considered to be minimal invasive and minimal traumatic while having a     limitation with regard to the residual bone height. According to the consensus conference in     1996, OSFE technique without bone grafting should be limited to RBH ranging from 7mm to 9mm.     However, recent studies reported favorable results even with RBH of around 4mm. Moreover,     there is still controversy regarding the necessity of a grafting material in order to     maintain the space for new bone formation. Spontaneous bone formation was observed for OSFE     without grafting by some researches.      Due to the lack of randomized controlled trial (RCTs), there is still no clear guideline for     implant therapy in posterior maxillae with limited bone height. Neither is there any evidence     to recommend or contraindicate the application of grafting materials in combination with     OSFE.      The present RCT is aimed to evaluate the clinical success of OSFE with RBH of 2mm to 6 mm and     to study whether the application of grafting material in combination with OSFE will be more     favorable. The hypothesis is that the application of simultaneous grafting has no significant     advantage in terms of clinical success. Spontaneous bone formation can be observed with     implants placed using OSFE without grafting.      90 systemically healthy adults consecutively admitted for oral implant therapy will be     randomly assigned to 3 test groups. Only one implant system will be used to minimize the     implant-originated influencing factors. Bio-Oss® will be chosen as the bone substitute as it     is currently the typical xenograft available. Autogenous bone will be also used as it is     deemed as 'gold standard' for bone graft materials.      A panoramic radiograph and an intra-oral radiograph should be taken to assess the     pretreatment bone height under sinus. For T1 group, the autogenous bone chips harvested     during the drilling procedure will be mixed up with Bio-Oss®. And the mixture is placed into     the 'socket' by osteotomes when elevating the sinus membrane until the final depth. For T2     group, only Bio-Oss® will be placed into the 'socket' by osteotomes when elevating the sinus     membrane until the final depth. No grafting materials will be used for T3 group. The subjects     will be recalled for follow-up visits at 3 months, 6 months, 1 year, 2 years and 3 years     after surgery for clinical and radiographic examination. Implant protrusion length,     endo-sinus bone gain and crestal bone level will be measured on the radiographs using     specialized software. ANOVA will be performed for the success rates of the 3 groups.     Descriptive statistics will be used for the radiographic parameters.      The present study is aimed to provide preliminary evidence for an important clinical question     that whether OSFE is predictable and reliable with RBH of less than 6mm and whether the     application of grafting materials is necessary for this indication.   "
127213|NCT01619943|"     The New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to     decrease the number of normal computed tomography (CT) in mild head injury (MHI). The aim is     to compare the clinical performance of these 2 decision rules for indentifying patients with     intracranial traumatic lesions and those who required an emergent neurosurgical intervention     following MHI.   "
127214|NCT01619930|"     The purpose of this study is to compare an internet-based behavioral activation program with     a physical activation program, as treatments for mild to moderate depression. The added     effect of rationale and motivational interviewing will also be studied, as well as the     effects of relapse prevention program.   "
127238|NCT01619618|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This laboratory study is looking at biomarkers in samples from patients with     recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.   "
127215|NCT01619917|"     While the literature tends to support the use of laser therapy in the management of burn     scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser     therapy can be quite expensive when compared to other treatment modalities for burn scars,     and while promising, its true usefulness has yet to be conclusively demonstrated. For this     reason, our assessing the effects of fractional vascular lasers on burn scars. It has been     hypothesized that the fractional vascular lasers work on mature scars to decrease scar     formation, and the fractional laser works on scar that is quiescent to promote remodelling.     The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the     mesh pattern created by meshed split thickness skin graft).      Objective:      To determine the benefit of fractional vascular laser treatment in improving burn scar     height, texture, vascularity and pliability in late burn scars.   "
127216|NCT01619904|"     A Pancreas Transplant is the accepted treatment in patients with Insulin Dependent Diabetes     Mellitus (IDDM) and end-organ failure. Simultaneous Pancreas and Kidney (SPK) Transplant is     done in over 90% of cases. At present there is a 5- 8% 30-day mortality with over 80% graft     survival at 1 year. At Manchester Royal Infirmary (MRI) approximately 40 cases are done per     year.      Goal-Directed Therapy (GDT) involves fluid resuscitation intra-operatively and early in the     post-operative period, guided by cardiac output monitoring. The mechanism of therapeutic     benefit is thought to be related to improved tissue oxygenation and oxygen delivery. There     are a number of studies showing significantly improved biochemical markers of inflammation in     animal models and in studies on septic patients (patients with an overwhelming infection)     following GDT. Studies have also shown that GDT improves clinical outcome in post-operative     patients and in serum inflammatory mediators. These studies have looked at major abdominal     surgery but none have investigated transplant patients. Given the nature of surgery we feel     that our patients would benefit with reduced Intensive Care Unit stay, reduced length of     hospital stays and reduced rates of post-operative complications.      The study will be conducted on all adult patients undergoing pancreas transplant at MRI. It     will last for 2 years and we hope to recruit 60 patients      Patients will be randomised into Standard Therapy (ST) or GDT groups, with ST being current     practice. Each intervention will last for six hours post-operatively before continuing with     normal care thereafter. Omental fat biopsies will be taken from patients intra-operatively     and blood samples will be taken from patients at regular intervals for 72 hours intra- and     post- operatively. Patients will be followed up daily while an in-patient and at     three-monthly intervals in out-patients for 1 year.   "
127217|NCT01619891|"     Despite recent advances and even when receiving optimal therapy, patients with chronic heart     failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent     symptoms. The investigators have shown that patients attending the Leeds Integrated Heart     Failure Service are also frequently deficient in vitamin D and that the severity of the     deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and     response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle     contractile function, immune function, pancreatic insulin release, and neuro-hormonal     homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has     demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a     randomised, placebo-controlled developmental clinical study in 250 patients with CHF and     vitamin D deficiency. The present study is designed to detect whether vitamin D has     pathophysiologically important effects, as well as providing preliminary evidence of efficacy     and safety by examining cardiac function (using cardiac magnetic resonance imaging) and     submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to     inform a larger multi-centre efficacy and effectiveness study.   "
127218|NCT01619878|"     The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data     following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body     weight (BW) with uncomplicated falciparum malaria.   "
127232|NCT01619696|"     The objective of the present project is to validate the feasibility of a multimodal     radiological pathway while on chemoradiotherapy, in order to validate potentially predictive     factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.   "
127220|NCT01619852|"     The study seeks to investigate a safe and inexpensive strategy to reduce persistent     post-surgical pain that can affect up to 60% of patients undergoing surgical procedures. It     also seeks to investigate specific brain changes associated with the development of chronic     pain. This may lead to the development of more specific and more effective treatments.      Hypotheses:        1. Perioperative systemic lidocaine reduces the incidence of chronic pain in patients          undergoing surgical procedures.        2. There is a specific brain morphological/function change associated with the development          of chronic pain.   "
127221|NCT01619839|"     NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe     chronic pain - active as a mu agonist, but with inherent molecular properties designed to     provide a unique clinical profile, including most notably, reduced CNS side effects and an     attenuated attractiveness as a target of abuse.   "
127222|NCT01619826|"     The objective of this study is to use a randomized controlled design to determine whether     cardiorespiratory fitness training improves neurocognitive function and academic performance     during preadolescent development.   "
127223|NCT01619813|"     The purpose of this study is to find out if giving Reolysin in combination with docetaxel and     prednisone can offer better results than standard therapy with docetaxel and prednisone.   "
127224|NCT01619800|"     The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker     sensor which responds only by comparing physical activity, heart rate, and breathing rate;     compared to the accelerometer pacemaker sensor which respond only by comparing physical     activity and the heart rate in patients whose heart is unable increase its heart rate     according to increase physical activity or demand (Chronotropic Incompetence). Only one     pacemaker family will be used in this clinical trial whereas the out of box configuration     is the blended sensor which can also be made to act only as an accelerometer.   "
127225|NCT01619787|"     The goal of the proposed study is to apply experimental economics in an online grocery store     shopping model to examine the effects of pricing on hypothetical food purchases   "
127226|NCT01619774|"     The goal of this clinical research study is to learn if the combination of 2 drugs dabrafenib     and trametinib can help to control melanoma that has or has not spread to the brain. The     safety of this drug combination will also be studied.      Dabrafenib is designed to block the mutated BRAF protein. This mutation is only found in     moles of the skin and in melanoma cells. By blocking the protein, the drug may slow the     growth of or kill cancer cells that have the protein.      Trametinib is designed to block certain proteins that cause cancer cells to grow and     multiply. This may cause the cancer cells to die.   "
127227|NCT01619761|"     The goal of this clinical research study is to learn if giving cells called natural killer     (NK) cells after receiving a chemotherapy treatment and a UCB transplant can improve response     in patients with leukemia, lymphoma, or MM. The safety of this treatment and whether NK cells     can lessen the risk of graft vs. host disease (GVHD) will also be studied.      Patients with a disease that is CD20-positive will also receive rituximab on this study.      The first 3 patients enrolled on this study will not receive NK cells but will receive a cord     blood transplant.      UCB and NK cells may be able to kill leukemia, lymphoma, or myeloma cells that remain in your     body after chemotherapy treatment.      The UCB cells are also designed to increase blood production and strengthen your immune     system.   "
127228|NCT01619748|"     Peripheral vascular function is impaired in people with obstructive sleep apnoea who are     untreated compared with age-, weight- and sex-matched healthy controls.   "
127229|NCT01619735|"     The purpose of this study is to evaluate outcomes of an established procedure for treatment     of kidney stones that are present within the inner aspect of the kidney. This procedure is     called flexible ureteroscopy, which involves placing a small camera through the urethra while     anesthetized (asleep), up the ureter (the tube connecting kidney and bladder) and into the     kidney to the kidney stone. Then, the stone is broken into tiny fragments using a small laser     called a Holmium laser. While this treatment is a well-established option for treatment of     these stones, there are several different techniques used to help eliminate them from the     kidney. Some urologists treat the stone by a method called active extraction whereby the     ureteroscope is passed back and forth into the kidney to remove all visible stone fragments.     Others use a method called dusting whereby the stones are broken into tiny fragments or     dust with the intention that achieving such a small stone size will allow the stones to     pass spontaneously. There has not been a systematic and rigorous comparison of these     techniques in terms of treatment outcomes. By collecting information on the success of     treatment, the investigators hope to provide benchmark data for future studies of kidney     stone treatment and improve the care of all patients who need surgery for their kidney     stones.      The investigators hypothesize that the stone free rate for renal stone(s) 5-15 mm is around     90% and that the stone clearance rate with be 20% higher in those patients that undergo     complete stone fragment extraction versus those that undergo stone dusting (residual     fragments < 2mm).   "
127230|NCT01619722|"     Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease     (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in     France, because it is treatable by a diet low in phenylalanine. This plan is required upon     confirmation of diagnosis and continued until the age of 8 years. The current trend is to     continue the scheme at least until adolescence. Unlike other countries, in France there are     no recommendations for a plan for life. Knowledge about the natural history of PKU in     adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic     factors are poorly documented. On the other hand, there is no consensus on the therapeutic     management of this disease in adulthood and monitoring that could be directed towards the     detection of neurological disorders and nutrition. Social integration and quality of life of     adults PKU patients living in France have not been studied.   "
127231|NCT01619709|"     To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic     intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We     hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid     Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage     (probably related to hypertension).   "
127233|NCT01619683|"     To determine the effects of 12 months of treatment with Androxal on bone mineral density in     men with secondary hypogonadism.   "
127234|NCT01619670|"     Epidermolysis Bullosa (EB) is a very rare disease, with a severe impact on the life of the     patient and the caregiver. Epidermolysis Bullosa (EB) comprises a group of genetically     determined skin fragility disorders characterized by blistering of the skin and mucosae     following mild mechanical trauma. There is no specific proven treatment for any form of EB,     and the mainstay of clinical management is based on protection and avoidance of provoking     factors. Chronic nonhealing erosions and ulcers have been treated with conventional     split-thickness skin grafts. Alternatively some patients may benefit from the use of     autologous or allogeneic cultured keratinocyte grafts.   "
127235|NCT01619657|"     The purpose of this study is to assess whether 6% hypertonic saline (HS) is a safe and     effective preventive therapy in newborns and infants with cystic fibrosis (CF).   "
127236|NCT01619644|"     An exploratory phase 2 therapeutic trial in children from 6 to 21, RTS carriers, randomized     to be treated either with sodium valproate with the usual pediatric dosage (30 mg/kg/j), or     by placebo for one year.      The investigator would like to include children because they could best profit from it due to     their neuronal plasticity as CBP and EP300 take effect through neuronal and synaptic     plasticity.      The therapeutic effect of sodium valproate in RTS patients will be assessed thanks to a     clinical approach (learning and memory neuropsychological evaluation, fine motor skills     assessment by pointing), to a biological approach (histone acetylation functional tests), and     to imaging (morphological and functional MRI).   "
127237|NCT01619631|"     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) that     provides the feasibility, safety, and preliminary efficacy data required to design a large     scale trial evaluating Tai Chi for Chinese Americans with major depressive disorder (MDD) who     are not on antidepressant medications.   "
127240|NCT01619592|"     Inclusion criteria: adult diabetes patients on multiple daily insulin injections or using an     insulin pump; Internet users Exclusion criteria: having a severe mental illness Patients will     be recruited during the conventional consult. If they want to participate, they will get     detailed information regarding the study; after giving consent; they will sign the informed     consent form and they will get a unique study number.      The patient will than complete a questionnaire on a secured website (https://) using the     unique study number. After completing this questionnaire, the patient will be randomised     either into a group 'standard care + direct start with web-based diabetes education'     (intervention group) or they will enter into the other group (control) receiving standard     care. Three months after the start of the study, all patients will be asked to complete the     questionnaire again and the patients into the control group will also get access to 'standard     care + web-based diabetes education'. The questionnaire will have to be completed on months     6, year 1 and year 2. At the time of completing the questionnaire, HbA1c will be determined.     This is part of the routine examination in each participating hospital (UZGent and AZ     Nikolaas). The determination of HbA1c is not study-specific but the value will be taken into     the study.      The web-based questionnaire:      Patients will enter on a website including general study-information. They also have to     explicitly click a button to proceed to the questionnaire. After clicking on 'I am prepared     to participate in the study' they will see a second webpage retrieving some general     information. After receiving this real basic information; they will be redirected to a secure     website (https://) and will make use of a unique study number. Only the main researcher will     have the possibility to link the general information to the unique study number.      The informed consent form:      The patient will be asked for added information. He/she will have to sign specific pages     giving explicitly informed consent for information retrieved from the 'mutualiteit' (National     Health Service - NHS).      On the NHS information will be asked regarding the health costs. These figures should make it     possible to have a more objective figure of the costs associated to diabetes (care).      The patient can stop on every moment the study participation. Once decided he/she wants to     stop, he/she will receive standard care.      Study hypotheses: the QoL will improve by the use of web-based diabetes education; there will     be a reduction in costs using web-based diabetes education; there will be at least an     equal-stay or improvement of the HbA1c while using web-based diabetes education.   "
127241|NCT01619579|"     Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved     Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and     psychological assessment. This non-invasive device is able to rapidly raise the core body     temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating     element. The change in body temperature may change the sympathetic nervous system's activity     and thereby reduce Fibromyalgia pain.   "
127242|NCT01619566|"     Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber     characteristics. This can be used to predict which future patients will respond to     Duloxetine.   "
127243|NCT01619553|"     Keloids have a strong genetic component. The goal of this study is to identify genes and     regulatory elements on chromosomes that are the cause for keloids or contribute to keloid     scarring.   "
127244|NCT01619540|"     Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive     pulmonary disease (AECOPD).      This association is frequently underestimated with regard to the difficulty of clinical     diagnosis .      The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.   "
127245|NCT01619527|"     The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence     of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg     tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under     fed and fasted conditions) in healthy participants.   "
127246|NCT01619514|"     The purpose of this study is to evaluate the use of advanced quantitative mass spectometry     (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor and to     compare the protein profile between different subtypes of breast cancer (ER positive, HER2     positive, triple negative). A maximum of 100 breast tumor specimens will be obtained from the     NUHS Tissue repository, comprising approximately equal proportion of ER positive, HER2     positive, and triple negative tumors. Samples will be analyzed using advanced Mass     Spectrometry (Super SILAC) as a discovery platform to identify novel protein biomarkers that     may be important in cancer. DNA and RNA will also be extracted from tumor samples for     correlative analysis with the proteomics data. Genomics and proteomics data will be     correlated with clinical data including treatment response and survival data. Importance of     proposed research to science or medicine:Identification of tumor biomarkers may allow better     prognostication, follow-up, and selection of treatment for cancer patients in the future.     Potential benefits and risks: No direct benefit to the patient. Risk to the subjects is     minimal as there is no direct patient contact, and analysis is done on previously donated     tumor samples. Patients have previously provided consent to donate their samples for research     into the NUHS Tissue Repository.      Novel tumor biomarkers that determine tumor biology, including prognosis and treatment     sensitivity, may be detectable using the novel advanced quantitative mass spectromy method     (Super SILAC). Different subtypes of breast cancers will have different proteomic profiles     analyzed using super SILAC.   "
127288|NCT01618968|"     Relative Bioavailability Comparison study   "
127289|NCT01618955|"     The purpose of this study is to assess the usability of the VIBEX MTX device for SC     self-injection of methotrexate.   "
127308|NCT01618708|"     The primary objective of this study was to demonstrate any changes in assessments of pain for     participants receiving Synvisc-One compared to control.   "
127247|NCT01619501|"     The overall goal of this research is to enhance the investigators understanding of the     pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets.     By comparing gene expression between normal lung tissue and tumors growing in lung-specific     C/EBPa KO mice, the investigators have identified the Bmi-1 proto-oncogene as being     abnormally upregulated in C/EBPa-deleted tumors. Subsequently, the investigators have     validated this observation in human lung cancer, implicating the investigators KO mice are an     effective discovery tool for lung cancer research. Through similar approaches, the     investigators have already identified (Sonic Hedgehog, SHH), and plan to identify other     pathways which are abnormally regulated in C/EBPa-/- tumors. In parallel, the investigators     will proceed to define the clinical relevance of the SHH pathway and the other     newly-discovered molecular aberrations, by analyzing their expression and correlate it to     C/EBPa expression on the samples of patients with NSCLC at NUHS. If the investigators     preliminary data on Bmi-1 will be confirmed, this proto-oncogene may generate useful     correlates that could be used in diagnosis and treatment of lung cancer, as well as identify     new prognostic/predictive markers in lung cancer. Similarly, SHH pathway-components may     behave as potential biomarkers and therapeutic tools for C/EBPa-related lung cancers.      This proposal seeks to test the hypothesis that pathways which are dysregulated in lung     tumors growing in a lung-specific C/EBPa KO model can be utilized as discovery tools to     identify genes involved in human lung cancer pathogenesis.   "
127248|NCT01619488|"     This study is to determine if the Lap-band system is safe and effective for use in morbidly     obese adolescents.   "
127272|NCT01619176|"     Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.      The molecular bases of this recommendation are not known, the investigators want to compare     with the usage of high-throughput molecular technologies the variations occurring in patients     treated with acupuncture and conventional treatment with the ones treated with conventional     treatment only. The investigators observe the variations in blood and in the gut microbiome.   "
127249|NCT01619475|"     The study is being conducted for the following reasons:        1. To determine the prevalence, course, and predictors of poor Health Related Quality of          Life (HRQOL) outcomes associated with living donor donation.        2. To collect data and biosamples prior to, during, and after a living donor liver          transplant (LDLT) among all donors and recipients for use by other adult-to-adult living          donor liver transplant studies and future studies.        3. To study the effects of pressure and flow on the outcomes of LDLT.        4. To characterize the differences between living donor liver transplant and deceased donor          liver transplant in terms of recipient post-transplant outcomes including patient and          graft survival, surgical morbidity, and resource utilization.        5. To compare the long-term histological outcomes in recipients of LDLT and deceased donor          liver transplant (DDLT) with recurrent hepatitis C virus (HCV) infection.        6. To understand the history of pain management and to measure quality of care in pain          control in living donors following partial hepatectomy.   "
127250|NCT01619462|"     The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent     pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New     Guinean children, who experience early dense upper respiratory tract colonisation with a     broad range of pneumococcal serotypes, and to compare antibody titres following a booster     dose of polysaccharide vaccine at 9 months with those children who received no booster at the     same age.   "
127251|NCT01619449|"     To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic     liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters.     The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is     associated with increased solute removal and improved acid-base statues when compared to     controls who do not receive CRRT   "
127252|NCT01619436|"     The purpose of this study is the randomized blind research of the assessment of the different     levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass     (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during     cardiac surgery, the investigators would like to know if the glycemia levels in clondine     group will be lower than placebo group.   "
127253|NCT01619423|"     The present trial is designed to determine whether pre-treatment with PledOx lowers the     frequency and severity of side effects from FOLFOX6 administration in patients with     metastatic colorectal cancer.      The efficacy of two different doses of PledOx will be assessed when added to FOLFOX6     chemotherapy as first line treatment of metastatic colorectal cancer.   "
127254|NCT01619410|"     In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of     S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either     linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the     investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of     ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus     isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient     population before and after therapy. Given the results of a recent study on linezolid and     vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA     carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous     abscesses than it is with oral clindamycin.   "
127255|NCT01619397|"     This Clinical Investigation is designed to provide tolerance, acceptability and safety data     of a new condom coating, in its intended use to support future application for CE Mark.   "
127256|NCT01619384|"     This proposed study aims to determine whether decreasing stress levels in persons with     posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota,     assessed 8 weeks after enrollment.   "
127257|NCT01619371|"     The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical     device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.   "
127309|NCT01618695|"     The purpose of this study is to confirm the efficacy and safety of perampanel compared to     placebo in patients with refractory partial-onset seizures   "
127310|NCT01618682|"     The investigators hope to gain insights into the functional organization of the human     cerebral cortex in response to upper limb amputation and surgical interventions including     hand replantation and hand transplantation.   "
127258|NCT01619358|"     Multiple myeloma is an incurable bone marrow cancer characterized by an abnormal expansion of     plasma cells that secretes monoclonal immunoglobulin. Over the years, the molecular and     genetic heterogeneity of the disease have been dissected. With the maturation of     technologies, the time is ripe now to apply genomics to diagnose, classify, risk-stratify and     prognosticate myeloma in the clinical setting and use this information to guide current     treatment. The investigators hypothesize that the use of gene expression profiling as a     single test will be more economical, efficient and accurate compared to the current standard     panel of tests done at diagnosis. The investigators also hypothesize that the investigator     can use predictive markers to identify prospectively patients who will respond to Velcade and     that with more effective trebasedonatment, ability to measure depth of response beyond     conventional complete response become important since more patients are achieving     conventionally determined complete response. Using a cohort of patients treated on a standard     treatment protocol based on Velcade-based induction treatment followed by consolidation and     maintenance treatment, the investigators will study specifically the feasibility and accuracy     of gene expression diagnostics, the predictive power of the investigators predefined     predictive markers and the clinical utility of minimal residual disease measurement in     myeloma. The results of the investigators study will allow us to improve the diagnosis, and     prognostication of MM patients        1. The investigators hypothesized that this will speed up diagnosis, provide comprehensive          information for the classification and risk stratification of MM patients and can          completely replace the current FISH assay and may be cheaper.        2. The investigators hypothesized that TRAF3 deletion or mutation and MYC activation will          identify patients that will have a significantly better response to Velcade.        3. Modern treatment induced deeper response. More sensitive method of disease detection          will allow us to know the fully extent of response to these treatment   "
127259|NCT01619345|"     This trial is conducted in Europe. The aim of this trial is to investigate whether the volume     of water administered with NN9924 affects the anatomical location (stomach or proximal small     bowel) of tablet erosion.   "
127260|NCT01619332|"     This study is a three part study to assess the safety and efficacy of LEZ763 on normal     healthy volunteers and patients with Type 2 Diabetes.   "
127281|NCT01619059|"     The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple     combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes     after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of     this treatment will also be studied.   "
127282|NCT01619046|"     The purpose of this study is to assess the safety, efficacy and pharmacokinetics of     GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days)     with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor     VIII).   "
127283|NCT01619033|"     This is an open, parallel group study in subjects with normal renal function compared to     those with renal dysfunction.   "
129098|NCT01595321|"     The purpose of this study is to estimate safety of a whole cell vaccine with immune     modulating doses of cyclophosphamide followed by SBRT and FOLFIRINOX chemotherapy in     pancreatic cancer patients after surgery.   "
127261|NCT01619319|"     Onset of psychotic disorders such as schizophrenia, typically occurs during late adolescence     or early adulthood often resulting in chronic social and occupational disability. Deficits in     cognition and functional outcome often precede the onset of full-blown psychosis although to     a lesser degree than observed in schizophrenia. Recent progress in risk identification     methodology has enabled reliable detection of persons who appear to be putatively prodromal     for psychosis, that is, at clinical high risk (CHR) of developing a psychotic disorder. Since     these CHR individuals already evidence cognitive deficits, which increase around the time of     conversion, cognition is an excellent treatment target. Furthermore, there is clear evidence,     in schizophrenia and in CHR samples, that deficits in cognition are related to poor     functional outcome. Thus, treatments targeting cognition may consequently improve functional     outcome. The primary aim of the project is to reduce cognitive deterioration and improve     cognition among youths at CHR using cognitive remediation and to test the effectiveness of a     new cognitive remediation program, the Brain Fitness program, in improving cognition of CHR     individuals. A control treatment consisting of video games (VG) will be used. The primary     hypothesis is that the BF group will have improved cognition at the end of treatment and 12     months post baseline compared to the VG group. A secondary hypothesis is that improved     cognition will be associated with improved functioning. This is a longitudinal, single blind,     placebo controlled pilot trial of cognitive remediation in 36 CHR persons. Participants will     be randomised to either the BF or VG program, which will be administered over a period of 3     months. Assessments will occur at baseline, post treatment (3 months) and at 12 months after     baseline. All subjects will be recruited in year 1 of the project and treatment will be     completed by 15 months. The 40 hours of training will occur 4 days a week, for an hour each     day, over a period of 10 -12 weeks.   "
127262|NCT01619306|"     Objectives:      Primary objectives:      • The investigators aim to conduct a questionnaire survey in a South-East Asian tertiary     institution, to assess whether breast cancer patients and their physicians would consider the     use of three different kinds of genetic tests currently available to breast cancer patients:        -  BRCA1/2 germline testing,        -  CYP2D6 genotyping and        -  Oncotype DX® testing.      Secondary objectives:      To explore factors which might influence their decisions on genetic testing, including:        1. Acceptability of the tests and anti-cancer management based on the test results        2. Reliability and affordability of the test        3. Ability of the test to influence treatment decisions        4. Broader implications of the test, e.g., psychosocial, financial impact Study design:          Cross-sectional study, Survey Questionnaires were developed for 3 categories of          individuals:             -  Patients with early stage breast cancer             -  Healthcare professionals caring for breast cancer patients             -  Medical students /cancer researchers The questionnaires for patients and medical               students/cancer researchers are similar. The questionnaires contain a brief section               on demographic information, interest in and past experience with genetic testing.               Three hypothetical situations are described to determine if participants will agree               to BRCA1/2 testing, CYP2D6 genotyping and Oncotype DX® testing, respectively. 18               categorical 'yes'/ 'no' questions explore reasons for their decisions. Each               scenario requires a short, hand-written response.      The questionnaire for healthcare professionals contains a brief section on demographics and     past experience with genetic testing. Three hypothetical situations are described to     determine if healthcare professionals will recommend their patients for BRCA1/2 testing,     CYP2D6 genotyping and Oncotype DX® testing, respectively. 12 categorical questions explore     the reasons for their decision, and physicians are required to rank these in order of     importance.      Distribution of questionnaires:      Questionnaires will be handed out to agreeable participants on the following occasions:        1. Patients- National University Health System Cancer Centre Level 3 amp; 4 waiting areas        2. Medical students - before or after lectures, or at personal contact        3. Cancer researchers - before or after lectures, or at personal contact        4. Healthcare professionals - before or after NUHS breast tumour board, or at personal          contact Due caution will be exercised to ensure that the questionnaire is only handed          out to subjects who are aged 21 years and above.      No subject identity will be collected for these questionnaires.      Rationale and Hypothesis:      BRCA1/2 germline testing, CYP2D6 genotyping and Oncotype DX® testing have all been approved     for use in clinical practice, but controversy still exists surrounding their utility, and     apart from BRCA1/2 mutation testing in high-risk individuals, genetic tests are not routinely     performed in Singapore. BRCA1/2 germline mutation testing is performed in individuals at high     risk for hereditary cancer. CYP2D6 genotype testing predicts the benefit of adjuvant     tamoxifen therapy; poor and intermediate metabolisers of tamoxifen may have a higher risk of     breast cancer recurrence due to lower efficacy of tamoxifen because of less efficient     conversion of tamoxifen to endoxifen, the active metabolite of tamoxifen. Oncotype DX®     testing is a gene-expression profiling test performed on a formalin-fixed paraffin embedded     tumour specimen, to predict the risk of breast cancer recurrence and guide decisions on     adjuvant chemotherapy. Understanding the attitudes of patients and medical professionals     toward these genetic tests may help to guide medical oncologists in their clinical     recommendations and utilization of these tests in breast cancer patients.   "
127263|NCT01619293|"     Abstract:      The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone     specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict     neuronal damage caused by traumatic brain injury. The investigators conduct a study to derive     and validate the measurement of S-100B in serum of patients with different types traumatic     brain injuries.   "
127264|NCT01619280|"     Acute lung injury (ALI) is caused by a wide variety of conditions, but always characterized     by hypoxia and non-cardiogenic pulmonary edema. Current treatment of ALI is supportive and     treatment of the underlying cause. New therapies to treat severe ALI have not been shown to     improve survival, and are limited by financial and logistical resources.      The investigators propose to investigate the role of inhaled sodium nitroprusside (iSNP) in     ALI. Sodium nitroprusside (SNP) is a vasodilator. When inhaled, SNP may travel to areas of     the lung participating in gas exchange, and cause the blood vessels surrounding these areas     to enlarge. This may result in an increase of blood vessels to these areas of the lung, and     improve oxygenation. Currently, iSNP has not been studied in the adult population. Therefore,     this study is intended to find the safety profile of varying doses of iSNP.   "
127265|NCT01619267|"     Infections related to implantable pacemakers or cardioverters defibrillators are sometimes     difficult to be diagnosed. Diificulties in the diagnosis include a low sensitivity of     standard markers of inflammation such as C-reactive protein or white blood cell count and the     diagnosis is mainly based on the clinical presentation. The observational DIRT-study     evaluates if new biomarkers may be more suitable to support a diagnosis of device associated     infections than the currently available ones.   "
127290|NCT01618942|"     This study was conducted to explore the influencing factors, subjects and testers' evaluation     about pain measurement with hand-held pressure algometer with different size probes.     Methods:100 healthy undergraduate students(50 males and 50 females) were recruited into this     study. Pain measurement including pressure pain threshold (PPT) and pressure pain     tolerance(PTO) was carried out by the hand-held pressure algometer with different size probes     (from 1cm2 to 0.01cm2) on three different measuring spots in right forearm. We recorded     subjects' skinfold thickness, time per test procedure, types of pain perception, receptivity     and degree of accuracy as well as testers' level of laborious.   "
127291|NCT01618929|"     -  To search the effects of montelukast on the airway inflammation including FEV1%,          FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge          tests, the leukotriene levels in the exhaled breath condensate in asthmatic children          with and without food allergy aged 6-18 years old.        -  To define the patient groups with good response to montelukast and to define the          parameters which predict the good response.   "
127266|NCT01619254|"     Impact exerted by intestinal parasitic infections is much higher in developing countries.     School-aged children are at higher risk from the burden of disease, because they specially     have many parasitic infections. The poor health results in deficits in physical and cognitive     development and educational achievements. Nowadays, there is huge commitment among the global     community to control intestinal parasitic infections and to improve nutritional status of     young children in developing countries.      Large-scale anthelminthic drug administration through vertical control programmes is still     required for the foreseeable future and is, therefore, recommended by the World Health     Organization (WHO). However, due to the inevitability of re-infection in endemic areas,     children need to be treated regularly, and once morbidity control is consolidated, the     strategy must shift to transmission control emphasising access to clean water and adequate     sanitation. To lower dependency on 'drug only' approach and to enhance sustainability, from     the onset of control activities, complementary measures should be implemented, that depend on     available resources.      Therefore, the investigators are proposing to undertake a randomised controlled trial to     assess the impact of simple and easy-to-do hand hygiene intervention packages (hand washing     with soap and hand finger nail clipping) on intestinal parasitic infection prevalence,     intensity and re-infection rates and on haemoglobin concentration and anaemia prevalence     rates among 6-15 years old schoolchildren. Our results will provide solid evidence on if and     how hand hygiene practice affects infection prevalence and re-infection rates, as well as,     anaemia prevalence among the highly vulnerable age group.   "
127267|NCT01619241|"     The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which     patients will have poorer progression free survival and overall survival in advanced     Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more     aggressive treatment.   "
127268|NCT01619228|"     The skin barrier lipids will be lower in premature infants than in full term infants and will     become normal over 3-4 months after birth. The higher skin pH in premature infants will be     related to an altered lipid composition which will change as the skin acidifies.   "
127269|NCT01619215|"     Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease.     In the absence of chronic alcohol abuse or other liver diseases, NAFLD incorporates a wide     spectrum of liver pathologies and is defined by fatty infiltration of the liver (simple     hepatosteatosis). It can progress to non-alcoholic steatohepatitis (NASH) and later fibrosis,     cirrhosis, and eventually some patients may develop hepatocellular carcinoma with or without     cirrhosis. The exact cause of NAFLD is yet to be cleared and it is, therefore, an active area     for research. The diagnosis of NAFLD is achieved through histological examination of liver     biopsies (invasive), non-invasive markers using serum biomarkers and imaging techniques are     still under development. Pathological diagnosis can be then subcategorized based on several     scoring systems. More widely used are the Brunt Score or NAS (NAFLD activity score) and the     Kleiner's modified NAS.      Obesity is highly associated with NAFLD, as the epidemic of obesity has made NAFLD more     prevalent. In addition insulin resistance has been linked to NAFLD and this is explained by     the increased influx of free fatty acids (FFAs) into the liver. FFA undergoes either     β-oxidation or esterification with glycerol to form triglycerides (TGs), resulting in an     additional source of fat in the liver. Due to the strong association of NAFLD with obesity,     weight reduction procedures are used for the management of NAFLD. In fact, this has been     shown to be effective by several studies. However, other studies have reported liver     deterioration after bariatric intervention. This conflict is what makes the effects of     bariatric procedures a challenging field for further studies. Consequently in this study we     are aimed to examine histologic, metabolic and liver function changes induced by the     different therapeutic bariatric procedures.   "
127270|NCT01619202|"     The purpose of this study is to examine differences in driving performance on a simulated     driving assessment between novice teen drivers who receive the Risk Anticipation-Perception     Training (RAPT) program and novice teen drivers who do not receive the training program.   "
127273|NCT01619163|"     Background: Osteoarthritis (OA), a common disabling condition, is the commonest type of     arthritis worldwide. Knee OA is the 4th leading cause of disability in women. Pain is the     leading symptom and is often chronic in nature leading to significant morbidity and decreased     quality of life. Synovitis is prevalent in knee OA and treatment to relieve this synovitis     may reduce pain.      Objectives: A randomized double-blind placebo-controlled trial will be conducted to assess     whether 6 weeks of daily low dose oral prednisolone will improve pain, mobility and systemic     low-grade inflammation, in the short term and to determine if it sustained long term at 12     weeks in older adults with moderate to severe knee OA.      Methods: 125 community-dwelling older adults aged 65 years and above with primary knee OA     diagnosed according to the ACR criteria for diagnosis of primary OA of the knee will     berandomized 1:1. Sixty three will receive 7.5 mg/day of prednisolone and 62 will receive     placebo together with their usual therapy for 6 weeks. The primary outcome measure will be     pain reduction. Secondary outcome measures will be reduction in systemic inflammation and     improvements in physical functioning scores. Alterations in dosage of analgesic/NSAID drugs     used will be recorded. Safety and tolerability were also assessed. Data will be collected at     baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at 6     weeks. Exclusion criteria will include any inflammatory or serious medical condition.      Knee OA will be documented by radiographic examination using the Kellgren-Lawrence scale.     Symptomatic OA will be defined as the need to take NSAIDs daily and LequesneAlgofunctional     Index (LFI)score > 4. Clinical assessment will be include: Visual Analogue Pain Scale (VAS,     0-100), self-reported physical function as measured with the Western Ontario and McMaster     Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores, and six-minute     walk distance (6MWD). All patients will undergo a physical examination and will be questioned     about the number of flares, pain and analgesic use. Blood samples will be collected and serum     levels of IL-1, IL-6, TNF-alpha and hsCRP will be measured in all patients.   "
127274|NCT01619150|"     The purpose of this study is to investigate which pain mechanisms that can be affected by     etoricoxib compared to placebo (inactive medication)in subjects with painful knee     osteoarthritis af 4 weeks of treatment.   "
127275|NCT01619137|"     Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin     treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study)   "
127292|NCT01618916|"     This is a phase 1 study in otherwise healthy participants with high LDL cholesterol.     Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body     handles the drug, and the drug's effect on the body will be evaluated. Participants will     participate in the study for approximately 3 months not including screening. Screening is     required within 42 days prior to the start of the study.   "
127293|NCT01618903|"     The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg     intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy     volunteers.   "
127311|NCT01618669|"     The purpose of this study is to demonstrate that the strength of agreement between single     photon emission computed tomography (SPECT) imaging with regadenoson following inadequate     exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the     strength of agreement between two sequential regadenoson SPECT images without exercise.   "
127965|NCT01610102|"     The primary objective of this study is to collect long term clinical follow-up data on all     patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0   "
127276|NCT01619124|"     Nowadays approximately 80% of children and adolescents with acute lymphoblastic leukaemia     (ALL) or lymphoblastic lymphoma (LBL) can be cured and become long-term survivors. Avascular     osteonecroses (ON) appear as serious side-effect of antileukaemic treatment. Frequently ON     are first diagnosed at higher and than irreversible stages (ARCO III, IV). At these advanced     stages curative treatment options are not available. Hence ON are associated with     considerable morbidity concerning pain and immobility and go along with long-term impairment     of quality of life. Therefore early diagnosis of ON in the follow-up of children and young     adults with ALL or LBL is a pressing object.      Within the prospective multicentric observational OPAL-trial patients at risk (aged 10 years     or older) treated according to the clinical trials ALL-BFM(Berlin-Frankfurt-Muenster Study     Group), COALL or NHL (Non Hodgkin Lymphoma)-BFM in Germany should be examined with regard to     the development of ON. By using a treatment associated, risk orientated assessment and     examination incidence, symptoms and the clinical course of ON are investigated. The validity     of MRI screening in the early diagnosis of ON in children and young adults is analysed.      Systematical investigation of patients under antileukaemic treatment is intended to     contribute to risk adapted diagnostic strategies and to serve as data base for the subsequent     evaluation of preventive and interventional approaches for the treatment of ON. Long-term     objective is the reduction of ON-associated morbidity.   "
127277|NCT01619111|"     The HER2 status in breast cancer patients may change during the course of the disease. In 30%     of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive CTCs     can be detected in peripheral blood samples(1). At present, it is unclear if therapy based on     the HER2 status of CTC offers a clinical benefit for these patients. The DETECT III - trial     compares lapatinib, as HER2-targeted therapy in combination with standard therapy versus     standard therapy alone in those patients, with initially HER2-negative metastatic breast     cancer and HER2-positive circulating tumor cells.      As one of the first interventional trials based on the assessment of CTC phenotypes, the     DETECT III - trial aims to evaluate the efficacy of HER2-targeted therapy in patients with     MBC and HER2-positive CTCs as well as the significance of CTC as an early predictive marker     for treatment response.   "
127278|NCT01619098|"     Hospital readmissions are common, costly, and potentially preventable. They are also     potentially responsive to health system interventions. However, it is uncertain which     components of care transition interventions are efficacious, for which populations, and at     what cost. This randomized controlled study is part of a larger project that will evaluate a     three-tiered quality improvement (QI) intervention intended to reduce hospital readmissions     within 30 days post-discharge from an urban safety net hospital that serves a racially and     linguistically diverse population (the randomized controlled study evaluates Tier 3). Few     studies have evaluated care transition interventions to reduce readmissions among low-income,     diverse patient populations, and the accumulated evidence on the effects of these     multi-faceted interventions on readmission rates has been inconclusive. This project will     take advantage of a unique sequence of three QI innovations to reduce hospital readmissions     implemented beginning in 2007 in an integrated safety net health care system. The     discharge-transfer tiers are as follows: 1) Tier 1 includes a comprehensive, individualized     home care plan (HCP) reviewed by the medical service floor nurse with the patient prior to     discharge; 2) Tier 2 adds the electronic transmission of the HCP to the patient's primary     care medical home where, on the business day following discharge, a Registered Nurse makes an     outreach telephone call to the discharged patient to confirm comprehension of the HCP and to     address medical questions or needs; 3) Tier 3 further adds a community health worker, the     Patient Navigator, to participate in bedside discussions to develop rapport and learn about     patients' home situations, weekly outreach calls to assess patients' needs and to facilitate     communication between the patient and the primary care team, and reminder calls to patients     prior to all medical appointments to eliminate barriers to outpatient follow-up. The Aim of     the study being registered is to evaluate the effects of an ongoing randomized natural     experiment on readmissions, health care use, adherence to medication instructions, and     preparedness for discharge. This natural experiment features random assignment to one of two     QI interventions, Tier 2 or Tier 3, and exclusively targets patients at high risk for     readmission, those with one or more of the following risk factors for readmission: discharge     diagnosis of congestive heart failure or COPD; length of stay > 3 days; age > 60; or previous     hospitalization within the past six months.      The investigators hypothesize that the Patient Navigator intervention (Tier 3) compared to     usual care (Tier 2) will increase the rates of 30-day post-discharge PCP visits; reduce     30-day hospital readmission rates; and reduce the total number of days in hospital in the 180     days following the index admission for high risk patients. The investigators further expect     that the PN intervention will improve patient adherence to medication instructions in the HCP     and reduce the probability of reported problems with post-discharge care.   "
127279|NCT01619085|"     The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in     patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the     follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and     1199.34), who wish to continue treatment with BIBF 1120.   "
127280|NCT01619072|"     This randomized controlled community-based trial will assess the effectiveness of     administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with     standard of care for postpartum hemorrhage treatment at the community level, primarily home     births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar     districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this     setting is referral to a higher level health facility.   "
129099|NCT01595308|"     How daily consumption of pomegranate juice affects the concentration, morphology or motility     of sperm in healthy men.   "
127284|NCT01619020|"     Colorectal (CRC) cancer is the third most common cancer in the United States and its     incidence is rising in younger populations. Diet seems to affect risk for CRC.      Many parts of our diet are processed and modified by the microbes or bacteria in our gut.     There are many different types of bacteria in our gut, each one of us has a community of     different types and amounts of each type.      When we eat flaxseeds, certain types of bacteria will process them - producing compounds that     can then affect our body. How much of these compounds are produced by each person depends on     the community of bacteria in the gut.      Flaxseed and in certain nuts contain lignans, compounds that may have health benefits. Gut     bacteria can convert the lignans into biologically active compounds that in animal models     prevent the development of colon cancer. The investigators will study how these biologically     active compounds affect colon cell-signaling pathways important to colorectal cancer risk.      Results from our study will bridge the current knowledge from animal studies and     epidemiologic studies and may help to inform approaches for future CRC prevention.   "
127285|NCT01619007|"     Following the findings of the clinical trials in drug development, this global     non-interventional cohort field study will investigate rivaroxaban under clinical practice     conditions in comparison with current standard of care for patients with acute deep vein     thrombosis (DVT).      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of     acute DVT in routine clinical practice.   "
127286|NCT01618994|"     A study to determine whether completing a rigorous simulation protocol could provide novice     robotic surgeons with actual advanced surgical skills in an operating room setting.   "
127287|NCT01618981|"     The purpose of this study is to assess left atrial pacing therapy in patients with atrial     dyssynchrony syndrome and heart failure with preserved ejection fraction.   "
127294|NCT01618890|"     Study hypothesis:      Hepatic venous pressure gradient (HVPG)-directed primary prophylaxis with nonselective     beta-blocker therapy (NSBB) leads to a reduction in first variceal bleeding episodes and is     cost-effective in the long term.      Study design:      A multi-center randomized controlled study comparing nonselective beta-blocker therapy guided     by the hemodynamic response as determined by the difference in HVPG before and after starting     oral NSBB therapy, to standard heart rate-guided NSBB therapy in patients with esophageal     varices due to liver cirrhosis without a history of esophageal variceal hemorrhage.      Primary study parameters/outcome of the study:      First variceal bleeding episodes occurring within the first two years.      Secondary study parameters/outcome of the study:        -  Mortality        -  Occurrence of other cirrhosis-related complications        -  Occurrence of hepatocellular carcinoma        -  Costs of treatments        -  Adverse effects   "
127295|NCT01618877|"     The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg     intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.   "
127296|NCT01618864|"     This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in     wrinkle and rosacea treatment.      Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then     twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the     clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.   "
127297|NCT01618851|"     This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT     with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will     be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy     in 25 fractions).   "
127323|NCT01618513|"     Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily     used after insufficient surgical intervention, but also as primary medical treatment in     selected patients. Evaluation of treatment control is based on monitoring blood levels of     growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease     control during SA treatment is not always straightforward. It is usually based on     normalization of IGF-I and achievement of a certain GH level. In approximately 40% of     patients discordant values of GH and IGF-I levels are seen after treatment with SA, with     normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is     unknown, but it indicates that SA may affect this difference.      The primary objective of this study is to investigate if disease control during SA treatment     is best achieved by monitoring either GH or IGF-I.   "
127298|NCT01618838|"     Radiation therapy is a well-established treatment modality for clinically localized prostate     cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live     with the side effects for many years. Attempts have been made to protect surrounding tissues     while delivering high dosage of radiation to cancer. With the rectum being so close to the     prostate, many patients still suffer from side effects caused by radiation injury to the     rectum, especially those who received conventional external beam radiotherapy.      CyberKnife is an FDA approved radiosurgical devise. Its flexible robotic arm allows radiation     beams to be delivered in different directions, providing a highly conformal, uniform dose     with steep dose gradients. Therefore, treatment with the CyberKnife radiosurgical system     should minimize the toxicity to the surrounding structures. CyberKnife System also     incorporates a dynamic tracking system to allow the robot to correct the targeting of     therapeutic beams during treatment. These improvements allow for dose escalation within the     prostate with less normal tissue toxicity.      The purpose of this study is to estimate the proportion of patients with endoscopically     detectable telangiectasia as the indication of radiation injury to the rectum, after     CyberKnife Treatment for prostate cancer.   "
127299|NCT01618825|"     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,     balanced, single dose pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fed     condition in healthy adult human subjects.   "
127300|NCT01618812|"     In a group of children with severe and painful flatfeet lengthening procedures of calcaneus     can be indicated. In this study the investigators use an artificial bone graft technique to     avoid removing bone graft from the iliac crest.   "
127301|NCT01618799|"     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,     balanced, single dose pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fasting     condition in healthy adult human subjects.   "
127302|NCT01618786|"     This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to     falls in a long-term care facility, determine the cost effectiveness of this intervention,     and assess perceptions about compliant flooring among staff, residents, and families.      The investigators hypothesize that compliant flooring will (1) reduce the incidence of     injuries due to falls in long-term care residents; (2) represent an overall cost-savings when     material and implementation costs are considered relative to direct and indirect costs     associated with injuries due to falls; and (3) be received positively by staff, residents,     and their family members.   "
127303|NCT01618773|"     This observational study is designed to assess the long-term efficacy and safety of Epiduo     (alone or in combination with other drugs) under daily clinical practice conditions in     patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on     quality of life and patient adherence will be assessed under marketed conditions.   "
127304|NCT01618760|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fed condition in normal,     healthy, adult human subjects.   "
127305|NCT01618747|"     This single-arm, open-label, multicenter, observational study will evaluate the efficacy and     safety of Avastin (bevacizumab) in patients with glioblastoma multiforme in first or second     relapse. Data will be collected from eligible patients initiated on Avastin treatment     according to local label for up to 3 years.   "
127306|NCT01618734|"     TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP)     who received alternatively romiplostim and eltrombopag.   "
127312|NCT01618656|"     Cannabis dependence is associated with changes in the brain's cannabinoid system. When     cannabis dependent individuals try to quit using cannabis, some of them experience problems     that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the     problems related to quitting cannabis may facilitate abstinence. One way to do this is by     harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids.     One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the     problems related to quitting cannabis use will be reduced by increasing the brain levels of     anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will     be less likely to relapse. Brain anandamide levels will be increased by blocking the     breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of     a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied     in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent     subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The     trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient     treatment phase and a 8 week follow-up phase. Abstinence and relapse will be measured at     various times during this 12 week study.   "
127313|NCT01618643|"     Acetic acid chromoendoscopy is an established standard technique used to detect dysplasia     within the gastrointestinal tract. Acetic acid spray helps to identify neoplasia by     highlighting the surface pattern, highlighting the vascular pattern and by a process known as     the aceto-whitening reaction, where tissues take acetic acid and turn white for a brief     period and then slowly revert back to a normal colour. The neoplastic surface and vascular     pattern are all very well described, and have played a big role in the recognition of early     cancer. The aceto-whitening reaction is well described but the differential in timing between     neoplastic and non-neoplastic areas is not well understood.      The investigators aim to establish the differential in the timing of the disappearance of the     aceto-whitening reaction between healthy tissue, dysplastic tissue, intramucosal cancer and     invasive cancer after acetic acid dye spray in the oesophagus and colon. By understanding     this better, the investigators may be able to predict with greater accuracy whether a     highlighted abnormal area is cancer or high grade dysplasia, or whether it is low grade     dysplasia or inflammation, which has significant prognostic implications for the patient.      The investigators hypothesize that the differential in the timing of the disappearance of the     aceto-whitening reaction between normal and abnormal tissue could help in the detection of     gastrointestinal neoplasia.   "
127314|NCT01618630|"     Severe burns result in persistent and extensive fat deposition in liver and muscle tissue.     This may be related to the prolonged insulin resistance observed following burn. In this     study the investigators will test the hypothesis that essential amino acids act in synergy     with exercise to improve liver steatosis and muscle lipid metabolism, and thus also affect     insulin sensitivity. Children with burns will participate in six weeks of exercise training     with/without amino acid supplementation. Before and after the intervention, measurements will     be done to determine muscle and liver fat content, muscle fat and protein metabolism, and     insulin sensitivity.   "
127315|NCT01618617|"     Subjects will be screened and will enter a placebo-only 2-week run-in period during which     constipation symptoms will be evaluated and any disallowed products (e.g. probiotics) must be     discontinued. Following successful completion of the run-in period, subjects will be     randomized to probiotic (high or low-dose groups) or placebo. Subjects will then consume     their assigned product daily for 6 weeks. Subjects will undergo abdominal x-rays on study     days 0 and 42 to assess transit time with each examination preceded by 6 days of radiopaque     Sitz marker ingestion. Subject diaries will be used to collect bowel movement frequency,     stool consistency, concomitant medications, and adverse events each day during the trial.     Stool samples will be collected at baseline and end of study to assess fecal probiotic count.     PAC-QOL, WCS, and GSRS questionnaires will be administered at baseline and day 42. 24-hour     food recalls will be administered at day 0 and 42 and the following parameters will be     assessed: total calories, carbohydrate, fat, protein, fiber, and liquid intake. Weekly     physical activity recalls will be completed.   "
127316|NCT01618604|"     Conditioned Pain Modulation (CPM) is a phenomenon which isn't examined enough. Many factors     of influence such as gender, age and psyche are already known - but the duration of such     effects, their reliability and the correlation between standardized Quantitative Sensory     Testing (QST) and CPM is still unknown.      In this study the investigators expect to find parameters in QST that correlate with the     efficacy of Conditioned Pain Modulation. Knowing factors that indicate high or low potential     CPM could help finding patients-at-risk and adapting their therapy.   "
127317|NCT01618591|"     The purpose of the trial is to develop the evidence on relative efficacy of 3 available     single-dose loperamide adjuncted regimens for watery diarrhea and a single-dose regimen, with     and without loperamide, for dysentery/febrile diarrhea required for informing decisions among     these regimens. Information from this study will be used to develop management guidelines for     the diagnosis and management of travelers' diarrhea (TD) among deployed United States and     United Kingdom military personnel.   "
127318|NCT01618578|"     The present study investigates by means of the rubber hand illusion body image stability and     sense of body ownership in patients with CRPS of the upper limb compared to patients with     unilateral pain of origin other than CRPS and age and sex-matched healthy subjects.   "
127319|NCT01618565|"     This trial tests whether hands-on training is superior to expert demonstration regarding the     management of shoulder dystocia (stuck shoulder) during delivery on a training model.   "
127320|NCT01618552|"     This study will determine whether practicing primary care providers (PCPs) can be trained to     support patient self-care of depression and co-existing diabetes during office visits, and     begin to explore whether this might improve depression and diabetes outcomes, and whether the     effects of the training generalize to patients with health conditions other than depression     and diabetes. This is important because most patients with chronic conditions struggle with     self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.   "
127367|NCT01617941|"     It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients     with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks.   "
127321|NCT01618539|"     General Anesthesia is usually produced by an intravenous agent and then maintained with a     breathing agent till the surgery is completed. However, there is a recent trend to produce     and maintain general anesthesia solely with an intravenous agent, such as propofol, in view     of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The     depth of general anesthesia can be measured by an anesthetic depth monitoring device called     Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well     established whenever a breathing agent is used to maintain general anesthesia. However, the     validity of using BIS with TIVA has not been adequately investigated. This study will compare     the BIS values at different doses of TIVA in order to establish any correlation between the     two. If such a correlation is established, BIS monitoring can safely be recommended to     determine anesthetic depth under TIVA.   "
127322|NCT01618526|"     Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have     anti-inflammatory effects and to change the composition of the faecal micro flora in the     colon.      In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome     are randomized to two types of diet intervention: a low and a high fiber diet. The     participants are subjected to endoscopy before and in the end of each intervention.   "
127451|NCT01616849|"     This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this     study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with     nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.   "
127324|NCT01618500|"     A novel computerised neuropsychological test battery for normal pressure hydrocephalus (NPH)     has been developed. The aim is to provide the clinician with a free of charge, standardized     tool, assessing the cognitive decline or improvements in the cognitive domains specific for     NPH. Results from the battery indicate good reliability and validity for the computerized     tests      Results from the computerised battery seems promising. However, ability for the battery to     detect cognitive improvements after a shunt operation remains to be tested.      Study objectives        1. Improvement after shunt. The aim of this study is to evaluate the effects of shunting on          neuropsychological performance in NPH patients, using a computerized battery.        2. Feasibility. The ability to complete the test battery by the intended patient group will          be tested.        3. Baseline profile. Baseline scores for NPH-patients will be compared to scores of healthy          individuals (from previous study).   "
127325|NCT01618487|"     The investigator hopes to determine if one of three current standard of care surgeries for     lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are:     arthroscopic tenotomy, open tenotomy, and debridement and repair.   "
127326|NCT01618474|"     This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus     capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage     IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the     optimal adjuvant regimen for such extremely high risk patients.   "
127327|NCT01618461|"     Research shows that well-developed icons and other pictorials aid in the comprehension of     medication information and are effective in improving patients' medication management. This     experimental study seeks to test the effect of icons and structured medication information on     subjects' processing and recall of simulated medication instructions in a computer testing     environment. The study planned to enroll 200 subjects.   "
127328|NCT01618448|"     A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy     and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients with Heart     Failure   "
127329|NCT01618435|"     The average life expectancy in Denmark is increasing resulting in an increasing part of the     population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes     constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,     especially when standing and walking, known as neurogenic claudication(Goh KJ FAU - Khalifa     et al.). LSS occurs in a combination of degenerative changes in the lower back, including     hypertrophy of the ligamentum flavus, arthrosis of the facet joints and bulging of the disc.      Current treatment of LSS is varied ranging from non-operative conservative treatment to     operation.      Operative intervention shows very good results according to physical ability and     pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),     but the most optimal treatment is still debated. Nevertheless, a decompression and, if     needed, a spinal fusion is recommended.(Ausman).      Clinical improvement including decrease of pain, improved ADL-function and an increased     quality of life are parameters of highest interest and the purpose of an operation is clear:     Making sufficient room for the affected nerves. In addition fusion is desired achieving     stability avoiding a new compression of the nerves. Studies attending these issues find a     correlation between fusion and clinical outcome, why obtained fusion of the affected levels     are very important(Andersen et al.;Andersen et al.;Girardo et al.;Kornblum MB FAU -     Fischgrund et al.).      P-15, bound to Anorganisk Bone Mineral (ABM), called i-FACTOR®, shows fusion superiority, no     side effects and no risk of transferring disease(Thorwarth et al. 5648-57;Thorwarth et al.     789-95;Wenz, Oesch, and Horst 1599-606;Scarano et al. 318-24;Kubler et al. 171-79) why the     investigators find this material suited for fusion surgery in the elderly.      To the investigators knowledge this is the first prospective study comparing fusion rates and     postoperative clinic with i-FACTOR vs allograft in older patients operated with decompression     and spondylodesis because of spinal stenosis due to degenerative spondylolisthesis.      Hypothesis:      There are no difference in the clinical parameters measured by ODI and fusion rates comparing     i-FACTOR® and allograft in non-instrumented posterolateral spondylodesis-operations in     patients 60 years and older.   "
127330|NCT01618422|"     This is a prospective, randomized, parallel, controlled study comparing the efficacy and     outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using     pretreatment susceptibility tests in selection of chemotherapy regimens and that in another     group without using pretreatment susceptibility test results. The investigators hypothesize     that selecting drug treatment on the basis of known susceptibility tests would lead to     improved outcome compared with empiric treatment.   "
127331|NCT01618409|"     The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language     illustrated medication instructions (PictureRx cards), compared to traditional medication     instructions, on Latinos' understanding of their medication regimens. The study will also     assess the effect on self-reported medication adherence. Patients with diabetes who attend     participating clinics are eligible. The target sample size is 200.   "
127332|NCT01618396|"     Previous studies have demonstrated that altered microvascular blood flow is an important     marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent     use of sedatives and it is unknown if these agents interfere or not on microvascular blood     flow. The goal of this study was to compare effects of propofol and midazolam infusions on     sublingual microcirculation of septic shock patients.   "
127333|NCT01618383|"     The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic     Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for     the development of Lewy bodies disease, and a careful look at discrepancies between these two     conditions may provide insight into the pathogenesis of PD. The early involvement of the     enteric nervous system (ENS) during PD led to theories that an as yet unidentified external     agent entering the ENS causes PD . If lesions of the ENS are found in patients who present     with a genetic form of parkinsonism would go against this notion, and thus provide insight to     the pathophysiology of the disease.   "
127334|NCT01618370|"     This study is a prospective, interventional, open-label, multi-center early access program     for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate     resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional     short and long term safety data on the product.   "
127357|NCT01618071|"     Many types of cardiovascular disease begin when the layer of cells lining blood vessels     (endothelial cells) start to function abnormally. This causes white blood cells (monocytes)     to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are     carried in the blood for 3-8 hours after a fatty meal in small particles known as     chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to     investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart     disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize     that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and     activate protective mechanisms to improve the function of arteries.   "
127335|NCT01618357|"     The investigators' primary aim is to determine the number of participants who can handle the     treatment within specific safety parameters, determine the number of participants who can     handle safely the maximum tolerated dose (MTD) (within 50-200 mg/BID dose range) when     combining Veliparib and radiation, as well as to identify side effects and their intensity at     different dosing levels.      The investigators' secondary aim is to determine the number of participants with     post-operative adverse events associated with POPI as well as the pathologic complete and     partial response rate in patients treated with POPI.      The investigators' exploratory aim is to serially assess apoptosis/proliferation biomarkers,     and gene and protein expression profiles for correlation with tumor response to POPI. This     will be primarily evaluated in the expansion cohort.      Study Plan:      It will be a standard 3+3 dose finding trial in which the MTD will be defined as the dose     below the level at which >1 DLT is observed in 3-6 patients. Women with node positive disease     prior to NAC and >1.0 cm residual breast disease and/or clinically positive nodal disease     after NAC will be offered participation in the research phase of this study.      Women with residual disease >1cm or +LN after NAC (Med Onc's choice) will be offered     pre-operative Veliparib and concurrent whole breast and regional nodal irradiation. Four (4)     dose levels of Veliparib will be evaluated with concurrent whole breast and regional nodal     irradiation (WB/RNI). The starting dose of Veliparib will be 50 mg BID, will increase in 50     mg increments to a maximum of 200 mg BID and be delivered concurrently with 235 cGy QD x 16     to the breast and SCV/Axilla. Once the MTD is determined we will further evaluate safety with     an expansion cohort which will bring the total number of patients treated at the MTD to 20.      Accrual: Up to 44 patients   "
127336|NCT01618344|"     To explore use of a smart-phone medication reminder application to promote adherence to oral     medications by AYA with cancer.   "
127337|NCT01618331|"     The hypotheses is that regular post exercise supplementation increase fitness and daily     activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.      All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen     consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of     falls and daily activity level.   "
127338|NCT01618318|"     In the past, doctors separated people with asthma into two groups, those with allergic     asthma (about 2/3rds of people) and those with non-allergic asthma. These labels are not     much used now as the treatments for all people with asthma don't depend on this     classification. However, new treatments for asthma may become available and the     classification may again become important. It could be useful for clinicians to know how to     identify which patients are likely to benefit from particular treatments.      Additionally, some new blood tests are becoming available and some of these might help to     categorise the type of asthma people have. What the study hopes to do is to identify patient     features which make a diagnosis of allergic asthma more likely and to see which new blood     tests are most likely to be helpful in confirming this diagnosis.   "
127339|NCT01618305|"     HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late     stages of pregnancy need an effective medication regimen to reduce the risk of transmitting     HIV to their children. This study will examine the virologic response, safety, and     tolerability of two different ARV medication regimens in HIV-infected pregnant women who are     between 20 and 36 weeks pregnant when they enter the study.   "
127340|NCT01618292|"     Compare changes in bowel function before, 6 months and one year after Robotic-assisted     laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one     year after Robotic-assisted laparoscopic sacral colpopexy.   "
127341|NCT01618279|"     The main aim of this study will evaluate differences in serum levels of tryptase in study     population. Will be selected a number of 350 patients hospitalized for coronary heart     disease.   "
127342|NCT01618266|"     Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.   "
127343|NCT01618253|"     To determine the maximum tolerated radiation dose with concurrent sorafenib for unresectable     hepatocellular carcinoma that has not responded to transarterial chemoembolization.   "
127344|NCT01618240|"     First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators     hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the     ability to protect the airway during swallowing in long-term ventilated subjects. More     specifically, the investigators hypothesized that low muscle strength is associated with the     inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus     residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS     scale [1-8]> 1), which should predispose to endotracheal aspiration.   "
127368|NCT01617928|"     This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) .     Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine     the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination     with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives     are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in     the subjects.   "
127369|NCT01617915|"     In 2011, there was an estimated 233,000 cases of invasive breast cancer, and 39,970 deaths     from breast cancer in the United States. The vast majority of patients are diagnosed with     Stage I-III resectable and potentially curable disease, and for these patients, the most     pressing questions are whether adjuvant endocrine or chemotherapy are indicated, and if so,     how to determine whether these treatments are working. Adjuvant systemic therapy reduces     relative recurrence rates by 30-50%, depending on the age of the patient and tumor     characteristics. However, patients with early stage disease often do not bear measurable     markers of disease such as an elevated cancer antigen 27-29 (CA27.29) or circulating tumor     cells. Patients with early stage breast cancer are typically treated with adjuvant therapy     based on historical evidence showing that such therapy prolongs survival in this population.      Lung cancer is the most common malignancy and the leading cause of cancer-related death in     the U.S. Approximately 220,000 new cases of lung cancer are diagnosed in the U.S. every year.     Unfortunately, lung cancers are often diagnosed at later stages than breast cancer, due in     part to little/no effective screening for lung cancer. As with breast cancer, patients are     commonly treated with chemotherapeutic agents, but treatment regimens can take several weeks     to months to elicit clinically detectable anti-tumor effects. A biomarker to assess early     tumor response to therapy would benefit this patient population.      The contents of dying tumor cells can be detected in the bloodstream, and this may be     enhanced by the leaky vasculature of solid tumors. Protein biomarkers of tumor cell death are     difficult to detect due to the complex nature of plasma and the lack of technical     sensitivity. In contrast, DNA is easier to detect through polymerase chain reaction (PCR)     amplification. Indeed, circulating tumor DNA has been detected in plasma from patients with     osteosarcoma, breast cancer, and colorectal cancer. Until recently, it was impractical to     develop an assay to routinely quantify circulating tumor DNA due to heterogeneity between     patients and tumors. Advances in genomic technology now permit sequencing a tumor genome to     identify patient-specific genomic aberrations. Major genomic alterations (i.e., insertions,     amplifications, deletions, inversions, translocations) can be readily detected using PCR     primers which will recognize tumor DNA but not normal DNA.      While this strategy may be generally applicable to diverse types of solid tumors, two issues     are apparent in breast cancer. Firstly, the incidence of chromosomal rearrangements varies     widely. Whole-genome sequencing of 15 breast tumors revealed a range of 1-231 major genomic     alterations (mean= 68), where 2 tumors had 1 alteration, and 9 tumors had > 20 alterations.     Single-base point mutations are more common but difficult to reliably detect using PCR.     Therefore, the investigators must consider that a small subset of patients may have a limited     number of genomic alterations available for this assay. Secondly, intratumoral heterogeneity     may mean that some genomic alterations are not present in every tumor cell. Such     heterogeneity has been inferred from FISH and immunohistochemistry (IHC) studies for many     years, and is now being verified at the genomic level. The investigators must consider that     only a subpopulation of tumor cells may be sensitive to cytotoxic therapy, so changes in the     levels of circulating tumor DNA may only be reflected with analysis of genomic alterations     specific to the sensitive cells.   "
127370|NCT01617902|"     This study aims to evaluate the incidence and risk factors of hyperbilirubinemia following     major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the     hyperbilirubinemia on postoperative mortality and morbidity.   "
127345|NCT01618227|"     Loss of wrist flexion and extension is a common problem after wrist and forearm fractures     that may lead to disability and unsatisfactory outcomes after fracture treatment. In many     patients, this range of motion loss is caused by stiffness of the soft tissues. Such     stiffness may loosen up and improve with rehabilitation. Static progressive splints apply a     constant stretch upon the wrist resulting in a stretch relaxation and plastic deformation of     the soft tissues. By altering the splint's bending angle, one can incrementally increase the     force applied on either wrist flexion or extension. There are no data comparing     rehabilitation with static-progressive splinting to rehabilitation without static-progressive     splinting for the restoration of wrist flexion and extension after wrist or forearm     fractures.      Primary study hypothesis:      Two months after study enrollment patients that use static progressive splinting have better     wrist flexion and extension than patients that use standard therapy techniques.      Secondary study hypotheses:        1. Six months after study enrollment, subjects that use static progressive splinting have          better wrist flexion and extension than those that use standard therapy techniques.        2. Motion at enrollment, 2 months and 6 months after enrollment correlates with negative          pain thoughts, pain anxiety, and depression.        3. Six months after study enrollment, subjects that use static progressive splinting have          had fewer physical/occupational therapy visits than those that use standard therapy          techniques.        4. Six months after study enrollment patients that use static progressive splinting have          had fewer additional surgeries than patients that use standard therapy techniques.      This study will employ a prospective randomized design. Subjects will be invited to enroll     during their routine office follow-up visit. Informed consent will be obtained. Subjects will     be randomized on a 1:1 ratio to rehabilitation with or without static progressive splinting.      All subjects will have a standard rehabilitation program including physical or occupational     therapy and home exercises throughout the study. The static progressive splint will be     prescribed according to the randomization sequence. Upon receipt of the splint, subjects will     be instructed in proper application and use by their treating therapist or a representative     of the company. Subjects will be instructed to follow the daily splint wearing protocol     provided by the device manufacturer. Use of the splints will be discontinued at the patient's     discretion or when a plateau phase in active range of motion is achieved (defined as no     measurable gains in active range of motion achieved in a 30-day period).   "
127346|NCT01618214|"     This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily     individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the     investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2     diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD     background treatment: Metformin plus/minus alpha-glucosidase inhibitor.   "
127347|NCT01618201|"     Migraine is prevalent in 10-12% of the population. It involves the development of a cranial     perivascular neurogenic inflammation. Recent information suggests that migraine might be a     risk factor to stroke. The possible mechanisms that might relate migraine and stroke are: 1.     Migraineous infarction 2. A primary endothelial disorder. 3. Genetic relation 4. An ongoing     inflammatory process. C reactive protein (CRP) is a sensitive marker for an inflammatory     process.The data on the relation of migraine to inflammation is limited. The aim of the     current study is to assess inflammatory factors as possible markers for migraine.   "
127348|NCT01618188|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in     subjects with type 1 diabetes.   "
127349|NCT01618175|"     Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all     population groups, and is usually due to respiratory syncytial virus (RSV) infection. The     main cause for hospitalization is often a need for oxygen, but can also include high fever     (with a suspected secondary bacterial infection) or increasing respiratory distress. In a     minority of cases (some of which can be identified in advance by defining risk groups) a     serious illness may develop, including risk of respiratory failure and death. Most cases will     just require supplemental oxygen and suction of secretions from the nose (as listed in the     recommendations of the American Academy of Pediatrics - AAP). However, this apparently     simple treatment still requires continued hospitalization. This results in a sharp increase     in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent     years two studies from developed countries have been published where safety has been     demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have     not been published yet, for example for populations living in poor conditions. The General     Health Services (Klalit) in Israel provides integrated hospital and community health service     to the majority of the population living o in our region, thus presenting an opportunity for     optimal interventions related to this disease.   "
127350|NCT01618162|"     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of     this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in     insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in     combination with metformin. All subjects will continue their pre-trial SU treatment with or     without metformin treatment without changing the frequency or dose throughout the trial.   "
127351|NCT01618149|"     The investigators hypothesized that the microarchitecture of bone influence the degree of     periprosthetic bone loss after total knee arthroplasty surgery. The investigators collected     the bone fragment at the distal femur while performing total knee replacement and take     quantitative radiography analysis . Before and after the surgery(6 month ,12 month) , the     investigators check the BMD at identical location of the distal femur by using dual energy     absorptiometry. The investigators will use linear regression to evaluate the relationship     between the microarchitecture and the degree of bone loss.   "
127352|NCT01618136|"     Overall Design: This is a multicenter, open-label, Phase 1/2 study which will be conducted in     three arms (as described below). Each arm will be conducted in two parts: a Phase 1 part     which will include dose escalation and a Phase 2 part which will include four cohorts in     specific disease indications. Phase 1 will also include a food effect study of E7449 as a     single agent. Once the MTD in the Phase 1 single agent arm and the Phase 1 combination arms     of this study has been achieved, the sponsor will submit the relevant safety information and     recommended Phase 2 dose to the IRB/Health Authorities. Arm 1: E7449 will be administered as     a single agent. Arm 2: E7449 will be administered in combination with TMZ. Arm 3: E7449 will     be administered in combination with carboplatin and paclitaxel   "
127353|NCT01618123|"     It is recognized that endothelial dysfunction is a major factor contributing to the     atherogenic process. Abnormal function of the endothelium is detectable prior to obvious     intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction is     a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its     complications. Measurement of peripheral vasodilator response with fingertip peripheral     arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging     as a useful method for assessing vascular function. EndoPAT may be a potential valid test     increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain     unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a relatively     fast non-invasive bedside test, relatively low-cost and has no side effects. Therefore, the     primary objective of the study is to test the hypothesis that abnormal endothelial function     as assessed by EndoPAT testing will increase the prediction of the short (in-hospital) and     long-term (1-year) outcome of patients presenting to the chest pain unit.   "
127354|NCT01618110|"     -  ADHD is one of the most common psychiatric disorders.        -  While most of the attention is directed towards youth, 60% continue to suffer symptoms          into adult life.        -  Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are          non-responders.        -  Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially          at right PFC.        -  It is this study hypothesis that by stimulating the right PFC by TMS, it will be          possible to alleviate ADHD symptoms.        -  A 10 sessions of treatment will by applied on a randomly allocated group of patients,          diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS          treatment, and the second group will receive a sham treatment.        -  Improvement of objective and subjective ADHD scale will be examined.   "
127355|NCT01618097|"     The purpose of this study is to advance the evidence base regarding methods for facilitating     informed decisions among patients with knee and hip osteoarthritis by comparing DVD and     online formats of decision aids for these conditions. The project will assess how these     different formats impact key outcomes including: patient knowledge about treatment options,     decisional conflict, preparation for decision making, decision self-efficacy, stage of     decision making, and acceptability and usability of the decision aids.   "
127356|NCT01618084|"     The Trident Tritanium acetabular component of a total hip prosthesis is a new developed     uncemented acetabular component. In this randomized controlled trial (RCT) the tritanium cup     will be compared with the Trident HA acetabular component in two equal sized groups. The     Symax HA coated stem will be used as femoral component in both groups.      Study Objectives:        -  The primary objective is to determine the prosthetic migration of the uncemented          acetabular and femoral total hip components using model based RSA technique        -  Secondary objectives are on one hand to assess clinical outcome on the other hand          assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score,          WOMAC, and EQ-5D questionnaires        -  Tertiary objective is to assess bone remodeling of the uncemented acetabular components          and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a          cohort of 12 consecutive patients of this RCT      A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients     have to fulfill the inclusion and exclusion criteria.      All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery     at 4 weeks, 3 and 6 months and 1 and 2 years.   "
127359|NCT01618045|"     Fermented Papaya Preparation (FPP) is a sweet and granular substance available over the     counter. FPP possesses antioxidant properties, which provide benefit against age-related     complications, and is also known to protect red blood cells (RBCs) against oxidative damage     and to help protect against severe forms of thalassemia. The investigators recently showed     that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic     peripheral blood mononuclear cells (PBMC) via a Sp-1 dependant pathway. Based on these     observations, the investigators propose to study the outcome that FPP supplementation has in     patients with diabetes.   "
127360|NCT01618032|"     Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability     (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries.     Passive mobilization techniques to improve ankle dorsiflexion are commonly used in     physiotherapy treatments. However, no studies have compared manipulative techniques of     mobilization techniques in subjects with chronic ankle instability.      The aim of this study is to compare the effects of two mobilization techniques on ankle     dorsiflexion in patients with chronic ankle instability.   "
127361|NCT01618019|"     The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid     (PUFA) can be beneficial for the patients with rheumatoid arthritis.   "
127362|NCT01618006|"     Cardiac bypass surgery is an important treatment for patients with severely blocked arteries     (tubes that delivery oxygen and nutrients to the heart). Hundreds of thousands of these     operations are done each year to help relieve patients' chest pain and to prevent future     heart attacks. The surgery is done by bypassing blood flow around badly clogged arteries by     sewing on healthy vessels from another part of the body (usually from the leg or the chest).     Aspirin (a blood thinner) is given to patients once a day after their surgery because it     stops sticky cells in the blood (platelets) from blocking these new vessels (which may lead     to a future heart attack).      Research has shown that aspirin does not work as well in people after they have bypass     surgery as the investigators might expect (for reasons that are not fully understood). One     reason aspirin may not work as well after surgery is because the body makes many more     platelets after surgery than it would under normal circumstances. All of these new platelets     overwhelm the aspirin and continue to be sticky and ready to block off arteries. The     investigators believe that giving multiple daily doses of aspirin following bypass surgery is     more effective than giving aspirin once daily at blocking platelet activity.   "
127363|NCT01617993|"     User questionnaire of Eeva System usability and reports of device malfunctions.   "
127364|NCT01617980|"     Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally     advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different     therapy protocols is variable, with hypoxia known to be a major factor that negatively     influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of modern     radiation therapy strategies, such as intensity modulated radiation therapy (IMRT), might     allow higher dose applications to the target volume, leading to improvement of therapy     outcome. 18F-fluoromisonidazole dynamic positron emission tomography and computed tomography     (18F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are attractive     strategies for imaging tumor hypoxia. The HIL trial is a single centre pilot study combining     multimodal hypoxia imaging with 18F-FMISO dPET-CT and functional MRI and intensity modulated     radiation therapy (IMRT) in patients with inoperable stage III NSCLC. 15 patients are     recruited in the study. All patients undergo serial 18F-FMISO dPET-CT and functional MRI     before treatment, at week 5 of radiotherapy and 6 weeks post treatment. Radiation therapy is     performed as inversely planned IMRT after four dimensional computed tomography (4D-CT) based     target volume definition. Hypoxia imaging is not included in target volume definition or IMRT     dose prescription.      Objectives of the trial are to characterize the correlation of 18F-FMISO dPET-CT and     functional MRI for tumor hypoxia imaging in NSCLC and evaluate possible effects of radiation     therapy on tumor re-oxygenation. Further objectives include the generation of data regarding     the prognostic value of 18F-FMISO dPET-CT and functional MRI for locoregional control,     progression free survival and overall survival of NSCLC treated with IMRT, which will form     the basis for larger clinical trials focusing on possible interactions between tumor     oxygenation and radiation outcome.   "
127365|NCT01617967|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of multiple doses of ALN-TTR02 in patients with transthyretin (TTR) mediated     amyloidosis (ATTR).   "
127366|NCT01617954|"     This is a prospective study that will assess the impact of MammaPrint on chemotherapy +     endocrine versus endocrine alone treatment decisions in patients with an Oncotype     Intermediate Score.   "
127372|NCT01617876|"     When performing screening endoscopy, small focal gastric lesions are frequently encountered.     Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging     (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to     enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of     gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been     proposed in the recognition of early gastric cancer (EGC).      This study is based on the hypothesis as follow:        1. The microvascular structure could be clearly observed with magnifying endoscopy enhanced          by narrow-band imaging (ME-NBI).        2. The microsurface architecture could be clearly observed with magnifying endoscopy          enhanced by acetic acid-indigocarmine mixture (ME-AIM).        3. Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE),          has higher sensitivity and specificity for the differential diagnosing small focal          gastric lesions.   "
127373|NCT01617863|"     The purpose of this study is to determine in soccer fans whether and to which extend positive     or negative emotions during the European soccer Championship affects Central Hemodynamics,     Arterial Stiffness, Heartrate and Endothelial Dysfunktion.   "
127374|NCT01617850|"     Physical rehabilitation is a key element in the treatment of patients with cardiovascular     diseases, and recent evidence has shown that supervised exercise programmes can prevent     cardiovascular events, improve physical function and quality of life. Individualized exercise     prescription based on appropriate frequency, intensity and duration is recommended.     Furthermore, recent studies have shown that physical cardiac exercise training can influence     inflammation of the vessel wall and hence reduce development of arteriosclerosis in coronary     vessels. In the literature are divergent conclusions on appropriate frequency and duration of     physical rehabilitation programs in order to improve physical function and reduce     arteriosclerosis.      The purpose of this study is to investigate the efficacy of an optimized physical     rehabilitation programme compared to a conventional programme on physical fitness, health     related quality of life and vascular inflammation.   "
127375|NCT01617837|"     The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea and     vomiting in neurosurgical patients undergoing craniotomy.   "
127376|NCT01617824|"     Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by     the co-existence of renal failure.      One key aspect of chronic inflammatory diseases is the alteration in the polarization profile     of circulating monocyte-macrophage cells.      Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an     anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to     contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which,     in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic     patients.      M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which     are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4     can affect the M1/M2 polarization balance.      In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin,     compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without     chronic renal failure.      In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects     endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the     pathobiology of diabetic complications.   "
127377|NCT01617811|"     The purpose of this study is to analyze the effects of epidural anesthesia and analgesia on     intraoperative clinical outcome, postoperative recovery, metabolic changes, and immune     functions of the patients receiving open liver resection.   "
127378|NCT01617798|"     Patients who are on mechanical ventilation in an intensive care unit often require diursis as     part of their pre-extubation regimen. The drug of choice for diuresis has traditionally been     furosemide. However, this drug cause hypernatremia (a rise in serum sodium) in a significant     proportion of patients. Hypernatremia is traditionally treated by providing free water     supplementation to the patient. This strategy creates a vicious and unproductive cycle of     giving free water, and then diuresing it off. We propose a strategy for breaking this cycle     by using a second diuretic-- metolazone-- which has a tendency to rid the body of more     sodium, thereby minimizing hypernatremia.   "
127379|NCT01617785|"     Coronary heart disease (CHD) pose a serious health threaten to population. Optimal     revascularization strategy in multiple vessel coronary artery disease patients remains a     subject of debate between interventional cardiologists and surgeons. Knowledge about the     real-life revascularization pattern and outcomes in China is limited. By consecutively     recruiting three vessel coronary heart disease patients in 23 geographically representative     highest-rank hospitals, this study will examine revascularization strategy, and various     real-life factors, that may affect patients lone-term recovery. Practical guidelines,     appropriateness criteria and quality evaluative system for revascularization strategy will be     established based on the findings, to improve patients outcomes in future finally.   "
127380|NCT01617772|"     The aim of the present study was to compare the effects of simvastatin and L-carnitine     coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver     elasticity in NASH patients.   "
127381|NCT01617759|"     Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in     immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive     procedures are hampered by neutropenia and low platelet count. Cerebrospinal fluid (CSF)     cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for     improving diagnostics. Therefore the performance of an established Aspergillus-specific     nested PCR in CSF samples of immunocompromised patients with suspicion of CNS IA will be     evaluated.   "
127382|NCT01617746|"     The purpose of this study will be to determine if blockade of endothelin 1 signalling via     endothelin receptor A using ambrisentan or dual blockade (A&B) via bosentan can provide     protection against methacholine induced bronchoconstriction in asthma.   "
127401|NCT01617499|"     The aim of this pilot study is to evaluate the effects of a worksite wellness program on     physical activity and cardiovascular disease risk factors among university employees. The     investigators hypothesize that the proposed worksite wellness program will be effective for     increasing daily physical activity and improving one or more cardiovascular disease risk     factors among university employees.   "
127383|NCT01617733|"     Nelson's syndrome, an expanding pituitary tumour, occurs in up to 30% of adults after     bilateral adrenalectomy for Cushing's disease, for which no medical treatment exists. Plasma     Adrenocorticotrophic hormone (ACTH) levels in these patients remain high, they are     characteristically deeply pigmented, and may experience neurological effects as a consequence     of the tumour. It is not known whether the tumour growth is due to the lack of cortisol     feedback after adrenalectomy or whether the pituitary cells were preprogrammed to develop     into a tumour.      There is a real need for an effective medical management for Nelson's syndrome. This is     especially true given the increasing data on the somewhat disappointing longterm outcome of     transsphenoidal surgery, and the increasing use of aparoscopic bilateral adrenalectomy for     failures of pituitary surgery or even as primary therapy for Cushing's disease. Therefore, it     is likely that there will be increasing numbers of patients attending endocrine centres     worldwide with Nelson's syndrome following bilateral adrenalectomy as part of their     management for Cushing's disease. In view of this it is important to investigate all     potential avenues for the treatment of Nelson's syndrome and translate any benefits to     patients.      This study, designed and initiated by the investigators, will assess if pasireotide reduces     ACTH levels and tumour volume in patients with Nelson's syndrome. Patients will be recruited     for a period of 32 weeks and receive 4 weeks of pasireotide twice daily and then 24 weeks of     pasireotide long acting release therapy every 4 weeks. Over the 32 week protocol patients     will make 12 visits for serial ACTH blood measurements and have 2 MRI scans to assess tumour     volume.   "
127384|NCT01617720|"     This Study is designed to observe the clinical outcomes of patients requiring mitral repair     that were treated with the CE certified Cardinal System.   "
127385|NCT01617707|"     Sedative endoscopic examination using sedative premedication has been undertaken to induce     conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely     used as a sedative premedication because it has lots of advantages, such as a short     half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However,     midazolam has been used regardless of whether or not alcohol although using midazolam in     chronic alcoholics is related to paradoxical reaction, characterized by increased     talkativeness, emotional release, excitement, and excessive movement. In recent years,     propofol has been used safety and effectively in sedative GI endoscopy because of its potent     hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was     conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam)     with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI     endoscopic procedures.   "
127386|NCT01617694|"     Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are     known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The     investigators will compare the effects of two drugs on prevention of cough during emergence     from general sevoflurane anaesthesia.   "
127387|NCT01617681|"     To assess efficacy, safety and tolerability of valsartan when comparing two doses of     valsartan in reducing and controlling blood pressure in children with hypertension with or     without CKD.   "
127388|NCT01617668|"     To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in     women with triple negative breast cancer whose tumors are positive for a defined pattern of     gene expression   "
127389|NCT01617655|"     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9     (proprotein convertase subtilisin/kexin type 9).      Primary Objective of the study:      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels     after 24 weeks of treatment in comparison with placebo.      Secondary Objectives:        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time          points        -  To evaluate the effects of alirocumab on other lipid parameters        -  To evaluate the safety and tolerability of alirocumab   "
127390|NCT01617642|"     Acute intermittent porphyria (AIP) is an autosomal dominant inherited disease, which is     relatively prevalent in northern Norway with a total of around 90 patients. This provides us     with a special opportunity to study AIP. AIP is caused by a mutation in the porphobilinogen     deaminase, an enzyme in the haem synthesis. AIP presents symptoms, particularly among fertile     women and older men. Typical symptoms are abdominal pain and dark red urine, nausea,     vomiting, constipation, muscle weakness and nerve damage including paraesthesia and even     paresis. This is known as symptomatic or manifest AIP (MAIP). Others do not display symptoms,     so-called latent AIP (LAIP). AIP attacks may be triggered by a host of medicaments which     affect the haem synthesis, infections, alcohol and stress. Treatments of manifestations     include high sugar intake (4 sugar lumps/hour), alternatively administer glucose and     Normosang (synthetic haem arginate) by intravenous injection and removing triggering factors.     Diet, glucose intake, dental health and inflammatory parameters will be examined. This study     can provide new knowledge about why only some people develop symptoms of AIP. Main     hypothesis: There are differences in the diet, iron status, inflammation and glucose     metabolism of the MAIP group vs. the LAIP group and the control group.   "
127391|NCT01617629|"     The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian     cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer     eligible for study participation due to disease progression.   "
127402|NCT01617486|"     This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for     Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT)     and designed to reduce overweight in postpartum teens. The intervention will focus on the     replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and     sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion     size, and walking).   "
127403|NCT01617473|"     The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic     transplantation setting as an alternative to bone marrow (BM).It was found that the use of     PBSCs is associated with faster hematologic recovery but have yielded differing results     regarding the incidence of graft-versus-host-disease (GVHD) and relapse.      The study hypothesis:      transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had     comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs   "
127392|NCT01617616|"     Dysautonomia, primarily defined as postural orthostatic tachycardia syndrome (POTS) can     seriously disrupt a child's daily activities. It is most commonly associated with nausea or     abdominal pain. In preliminary studies, when orthostatic intolerance was treated with     fludrocortisone, a standard therapy for orthostatic intolerance (OI), symptomatic improvement     in nausea was observed. However, children with POTS were also observed to have higher supine     mean arterial pressure (MAP) (preliminary data) and greater suppression of the baroreceptor     reflex sensitivity (BRS) occurred upon up-right tilt. While fludrocortisone alleviates nausea     associated with OI, its long-term use may pose long term health risks to children including     worsening hypertension. Therefore, it is the objective of this study to define the mechanism     for OI as it relates to nausea. The investigators hypothesize that OI resulting from changes     in the autonomic nervous system is the likely mechanism for the nausea observed in the     patients in this study. The investigators further hypothesize that this is potentially an     early marker for future cardiovascular problems such as early onset hypertension and cardiac     hypertrophy. The general objective of this protocol is to address this gap in knowledge by     determining the autonomic characteristics of children with OI as well as defining     neurohumoral profiles for these subjects to better understand the cause of the elevated     supine in these subjects. By better understanding the potential mechanism for this condition,     it is the investigators future goal to develop a more focused and safer treatment strategy.     The investigators will study subjects between 10 to 18 years of age utilizing the tilt table     to mimic daily life stressors and also measure serum levels of epinephrine, norepinephrine,     rennin, angiotensin II, aldosterone, and vasopressin at baseline and during tilt. This study     will generate data with high impact in that more rational treatments for management of     dysautonomia could be chosen on the basis of the profile of dysautonomia and neurohumoral     markers.   "
127393|NCT01617603|"     Type 2 diabetes is being acknowledged as a potential public health time bomb, whose incidence     is predicted to double over the next 10 years in the UK, associated with the rise in obesity     and increasing sedentary lifestyles. Increased insulin resistance has been shown to be an     important feature of type 2 diabetes (especially in those presenting with obesity and in     particular visceral or abdominal obesity). Insulin resistance is implicated as a risk factor     of cardiovascular disease and may lead to pancreatic dysfunction through increased β-cell     stress in the pancreas. A combination of insulin resistance and pancreatic beta cell failure     then leads to type 2 diabetes. The main cause of morbidity and mortality in type 2 diabetes     is cardiovascular disease as the condition is associated with impaired vascular functioning     and increased levels of oxidation markers.      Epidemiological studies suggest dietary flavonoids decrease the risk of death from coronary     heart disease, cancer, and stroke. Flavonoid-rich foods include fruits and vegetables as well     as tea, red wine, and chocolate. In a cohort of elderly men, cocoa intake was inversely     associated with blood pressure and 15-year cardiovascular and all-cause mortality. It has     been reported that in healthy humans, consumption of flavanol-rich dark chocolate decreased     daytime and night time blood pressure, reduced insulin resistance, and improved nitric oxide     dependent vaso-relaxation. Another trial found that cocoa powder increased postprandial     insulinaemia in lean young adults. These research papers have led to the hypothesis that     chocolate containing high cocoa liquor may help to reduce the risk of developing type 2     diabetes.      This study is design as a double-blind, controlled, single center, randomized, parallel     design clinical trial. The primary outcome measure is to compare parameters of insulin     resistance and glycaemic control in volunteers with type 2 diabetes after consumption of 3     different chocolates (one dark and two milk chocolates) with a secondary outcome of     endothelial function, cholesterol profile and oxidative stress. Subjects will undergo medical     screening, anthropometry, physical activity and dietary assessments before randomization.   "
127394|NCT01617590|"     This study was intended to assess the efficacy and safety of different Disease-Modifying     Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology     (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid     arthritis.   "
127395|NCT01617577|"     Filgrastim (G-CSF) is widely used for treatment of patients who have a deficiency of white     blood cells. It is also routinely used to stimulate and mobilize stem/progenitor cells for     bone marrow transplantation. In studies of thousands of healthy donor subjects treated with     G-CSF, the side-effects profile has been reported to be mild and reversible. Currently, G-CSF     is under investigation in clinical trials in Germany and the US that aim to enhance recovery     from strokes and heart attacks. In animal studies, G-CSF has been observed to improve     cognitive performance and to markedly reduce amyloid deposition in hippocampus and entorhinal     cortex in a mouse model of Alzheimer's Disease (AD). Since this drug is being used safely in     many people throughout the world, the investigators hypothesize that it will also be safe to     give to patients with Alzheimer's disease and that it may improve some aspects of memory and     thinking. The present pilot study has two goals or objectives: 1) to investigate the effects     of a five day schedule of Filgrastim administration on cognitive function and 2) to assess     its tolerability and safety in a small group (12 patients) with mild to moderate stage AD.     Patients who are eligible for the study will be randomly assigned to one of two groups (n=6     per group). One group will receive a five-day course of Filgrastim injections and the other     group of subjects will receive vehicle injections (solution without drug). At the end of the     first phase of the study (week 8), the groups will cross over to receive either vehicle or     Filgrastim as appropriate. In this way all subjects will have received the active medication     by the end of the study. After the study is finished the investigators should know whether or     not Filgrastim improves some aspects of thinking and memory. And the investigators should     know whether or not it is safe to give this medication to patients with Alzheimer's disease.     To ensure that the drug is safe, a Safety Monitoring Committee will oversee the entire study.     They will review all laboratory data, including complete blood counts, serum chemistry, EKGs     and adverse events.   "
127396|NCT01617564|"     Paracervical blockage can reduce severe pain during second trimester induced medical     abortion.   "
127397|NCT01617551|"     Catheter based renal denervation (CRD) in humans represents a promising new treatment of     resistant hypertension. CRD is currently investigated as a treatment option in patients with     resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in     a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are     randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which     CRD reduce blood pressure are only partly understood and the interaction between renal     sympathetic nerves and nitric oxide (NO) has not been investigated in humans.      To Study the interaction between NO and renal sympathetic nerves, we designed the present     substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are     studied before and after CRD.   "
127398|NCT01617538|"     Objective:      To monitor and evaluate the change of intracranial hemodynamics and MCA stenosis after     24-week atorvastatin treatment using CEUS, CTA and DSA.      Study design:      Total 30 patients (60 arteries) will be enrolled in this study, who had MCA infarction within     6 months prior to screening, and has not received any statins treatment before stroke.      Eligible patient will receive atorvastatin 40mg treatment for 24 weeks. Hemodynamics changes     and MCA stenosis will be evaluated using CEUS at baseline, 3-month,and 6-month. MCA stenosis,     bloodstream velocity, as well as clinical symptoms will be assessed at each visit and     compared to baseline.   "
127399|NCT01617525|"     The primary aim of this study is to compare, in a group of at-risk individuals, the role of     three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended     Korean pattern; b) the typical American diet, based on national dietary intake surveys; and     c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on     intestinal microbiota and on inflammatory biomarkers.   "
127400|NCT01617512|"     The purpose of this study is to determine if it is possible to identify activities in the     daily accelerometer measures of a person with urinary disorders.   "
127404|NCT01617460|"     The objective of this study is to investigate the safety and efficacy of aripiprazole orally     administered over long term in subjects who complete a short-term treatment study of     pediatric Autistic Disorder (031-11-002 study).   "
127414|NCT01617330|"     Proximity to traffic, particularly to diesel-powered heavy-duty vehicles, has been associated     with inducing and enhancing allergies in children and adults. To investigate the basis for     this association, a controlled exposure of allergic rhinitics to diesel exhaust was performed     at a dose known to be pro-inflammatory in healthy individuals.      The hypothesis was that airway inflammation would be augmented in allergic rhinitics     following exposure to diesel exhaust at an environmentally pertinent particulate matter     concentration.      Fourteen allergic rhinitics were exposed in a double-blinded, randomised trial to both diesel     exhaust at 100 microgram/m3 PM10 (representing an aerosol of nanoparticulate combustion     particles, mean diameter 80 nm) and filtered air for two hours on separate occasions.     Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours     post-exposure, and samples were analysed for markers of inflammation.   "
127465|NCT01616654|"     To assess the efficacy and safety of different concentrations of CD5789 cream in subjects     with acne vulgaris for the purpose of dose identification.   "
127407|NCT01617421|"     Background:        -  People with arthritis should be active. Regular exercise leads to less pain, more          energy, improved sleep, and better day-to-day function. Yet arthritis is one of the most          common reasons people give for limiting activities.        -  Yoga for arthritis has been studied before. However, few studies have included          minorities. Making changes to yoga classes based on language and culture may help people          use yoga to care for their arthritis symptoms. Researchers want to see if minority          populations with arthritis will come to and benefit from yoga classes.      Objectives:      - To see if yoga classes designed for people with arthritis will be acceptable to minorities     with arthritis.      Eligibility:        -  Adults at least 18 years of age who are enrolled in the Natural History of Rheumatic          Disease in Minority Communities study.        -  Participants will have osteoarthritis or rheumatoid arthritis.        -  Participants will be able to speak and read English or Spanish.      Design:        -  The total study period covers 10 weeks.        -  The first study visit will include an initial questionnaire about health and arthritis.          Participants will also have a physical exam.        -  Participants will have yoga classes twice a week for 8 weeks. The classes will be 1 hour          long each.        -  After completing the yoga classes, participants will complete another questionnaire          about their health. They will have a final physical exam.        -  Follow-up contact will be made 3 months after the end of the study.   "
127408|NCT01617408|"     Background:      - The brain has two systems for recognizing objects. One system recognizes what an object is,     and the other system recognizes where the object is located. However, there is much about how     the brain handles and interprets the information from these two systems that is still     unclear. Researchers want to study the parts of the brain that are involved in how vision is     processed. They will use magnetic resonance imaging (MRI) and transcranial magnetic     stimulation (TMS) on the brain. MRI measures what parts of the brain become more active when     tasks are performed. TMS uses magnetic pulses to temporarily change the activity in parts of     the brain.      Objectives:      - To better understand how people visually recognize different types of objects.      Eligibility:      - Healthy volunteers between 18 and 50 years of age.      Design:        -  This study includes many different experiments on vision. Each experiment may combine          visual tasks, MRI scans, and TMS. Participants may be asked to have several different          tests. Each test will require a separate visit to the National Institutes of Health.        -  Participants will be screened with a physical exam and medical history. They will have a          baseline brain scan at the first visit.        -  Participants may do visual tasks alone, with MRI only, with TMS only, or with MRI and          TMS combined. For the visual tasks, they will look at pictures of objects on a computer          screen. Sometimes the images will appear very briefly (less than one-tenth of a second).          Sometimes they will appear for up to 5 seconds. These images will be of things like          faces, bodies, tools, and scenes. Participants will be asked to respond in different          ways to the pictures. They may respond by typing on a computer keyboard or by pressing a          button. Participants will have time to practice the tasks before the experiment.        -  Participants will remain on the study for up to 3 years.   "
127409|NCT01617395|"     Background:      - Research shows that both genes and the environment influence a person s risk for getting     multiple sclerosis (MS). However, it is not possible to accurately predict who will develop     MS. Researchers want to study people with MS and their family members. They have developed a     Genetic and Environmental Risk Score for MS. This score combines information from a person's     medical history and genes. It also includes environmental factors that may be related to     developing MS. This study will test this risk score to see if it can help predict who will     develop MS.      Objectives:      - To evaluate a score for genetic and environmental risk factors that may help predict     whether a person will develop MS.      Eligibility:        -  Individuals at least 18 years of age who have MS.        -  Individuals between 18 to 50 years of age who are the parent, brother, sister, or child          of a person with MS.      Design:        -  People with MS will allow researchers to look at their personal and medical data. These          data will have been collected in other MS-related studies.        -  Relatives of people with MS will fill out a questionnaire and give blood and saliva          samples. They will fill out the questionnaire again one year later.        -  Some relatives will have additional optional testing. These tests will include a          physical exam and imaging studies. There may also be other tests. These tests may be          repeated every 1 to 5 years for 20 years.   "
127410|NCT01617382|"     The purpose of this study is to register the follow-up data of patients who, because of a     peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.   "
127411|NCT01617369|"     The purpose of this research study is to learn about how long hypertonic saline (HS) works in     healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic     Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up     in the lungs. Hypertonic saline and other medications currently being developed may help     patients with these lung diseases by speeding up mucus clearance from the lung. For these     treatments to be effective, they likely need to be able to act for at lease several hours.     Investigators are able to measure how lung treatments like hypertonic saline work by     conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how     long hypertonic saline works in people who do not have CF. Investigators plan to use this     information to improve the design and testing of new treatments for patients with chronic     bronchitis.      Objectives:        1. The investigators will use MCC measurements to determine the durability of action of          hypertonic saline in healthy (i.e. non-CF) subjects.        2. The investigators will determine the intra- and inter-individual variability of baseline          MCC measurements using a slow inhalation/large particle protocol in healthy subjects to          guide future sample size calculations.   "
129319|NCT01592435|"     The study objective is to acquire composite images generated by the Carestream Long Length     Imaging (LLI) software and demonstrate that the images stitched using the Carestream LLI     software and the images stitched using a approved predicate device are acceptable for     clinical use.   "
127412|NCT01617356|"     Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be     quite long lasting and debilitating. Dextrose injection with a small needle has be notably     helpful in preliminary studies in reducing pain and improving jaw function. This randomized     trial will compare dextrose injection with saline injection for temporomandibular(jaw)     dysfunction, also known as TMD.   "
127413|NCT01617343|"     Spatial neglect represents one of the major cognitive disorders following stroke. Patients     patients fail to be aware of objects or people to their left and orientate instead to their     right side. Enduring neglect has been found to be a poor prognostic indicator for functional     independence following stroke. Despite some promising experimental accounts there are no     established treatments for this condition.      The aim of this study is to test whether a combined treatment with hemifield eye patching     (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve     functional outcome in patients with hemispatial neglect following stroke.      The investigators hypothesise that the treatment with HEP and OKS will lead to a greater     reduction of neglect scoring in the neglect test battery as well as a greater improvement in     functional independence scores as compared to the spontaneous clinical course of the     usual-care control group.   "
127416|NCT01617304|"     The aim of the project is to investigate the effects of advanced glycation end products     (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the     human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is     that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii)     AGEs formation in the body is lower at low dietary intake of certain sugar forms.   "
127417|NCT01617291|"     The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the     pre-hospital setting of a four county emergency medical system (EMS) that serves both urban     and rural communities improves meaningful survival from medical cardiac arrest.   "
127418|NCT01617278|"     The purpose of the study is to assess whether the use of I-scan during colonoscopy leads to     an increased yield of adenomas in the colon among a population at increased risk for CRC.      Primary Outcome:      To estimate the mean number of adenomas per colonoscopy for both high definition white light     colonoscopy and I-scan enhanced colonoscopy      Secondary Outcomes:        1. To estimate the recruitment rate        2. Number of adenomas detected in the right colon during the second look   "
127419|NCT01617265|"     The purpose of the present study is to determine whether administration of sedation according     to a strategy including a bundle of measures to prevent oversedation is associated with a     reduction in mortality of intensive care unit patients requiring mechanical ventilation,     compared to administration of sedation according to usual practices.   "
127420|NCT01617252|"     The main objective of this study is to evaluate the gas exchange (ventilation-perfusion     ratio) with the system Optiflow® compared to facial mask among patients having an acute     respiratory failure after cardiac surgery.   "
127421|NCT01617239|"     The goal of the study is to assess the safety and immune response after vaccination with     different doses and vaccination schedules of virosomal influenza vaccine.   "
127422|NCT01617226|"     This is a multicentre, open-label, randomised phase II trial comparing azacitidine     monotherapy with combined azacitidine and vorinostat in patients with newly diagnosed,     relapsed or refractory acute myeloid leukaemia or high risk myelodysplastic syndromes     ineligible for intensive chemotherapy.   "
127423|NCT01617213|"     This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy     in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2)     with autologous PBSC transplant.   "
127424|NCT01617200|"     Participants who have completed the 6-week trial P05688 can be screened for eligibility for     this 26-week extension study in which they will continue treatment. The purpose of this trial     is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice     daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily     (QD) is used as an active control.   "
127425|NCT01617187|"     The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually     twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms)     as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15     mg orally once daily (QD) was used as an active control. The primary hypothesis is that at     least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms     as measured by the change from Baseline in the PANSS total score at Day 42. The first key     secondary hypothesis is that at least one of the asenapine doses is superior to placebo in     improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global     Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is     that at least one of the asenapine doses is superior to placebo in improving schizophrenia     symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS     Total Score) at Day 42.   "
127426|NCT01617174|"     The first goal of this study is to learn more about the experience of pain and other symptoms     in men being treated for advanced prostate cancer. The second goal of the study is to     identify reliable ways of measuring pain which will be used in future clinical trials of     treatments for advanced prostate cancer.   "
127438|NCT01617018|"     PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients     receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous     psoriasis. It is resulting from the merging of two studies that share the same study     population but address different objectives: PSOBIO, developed by academic dermatologists and     epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU     MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on     safety issues, and Pso-TEQ, developed by industrials at the request of the French     Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.      The overall general objective of PSOBIO is to assess in real life the safety and efficacy     of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional     systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use     of biological therapies in real life and long-term benefit.   "
129382|NCT01591616|"     To establish Oraqix is safe when used on adolescent volunteers.   "
127427|NCT01617161|"     We are studying whether men being treated for prostate cancer have the same amount of side     effects from either one of two different external radiation treatments: IMRT or PBT. With     IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another     type of external radiation treatment for prostate cancer that is used in a few centers in the     United States. Protons are tiny particles with positive charge that can be controlled to     travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams     instead of x-ray beams.      IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing     surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and     are thought to be equally effective at curing prostate cancer. However, both treatments have     also been shown to cause the potential side effects of radiation, including bowel, urinary     and erectile problems. It is possible that side effect rates with PBT will be lower, the     same, or even higher than with IMRT, but this has not been studied well to date. Though both     of these radiation therapies have been used in the past to treat prostate cancer, there has     never been a study that compares the effects of these two therapies to see which one has less     side effects.      In this research study, we are comparing IMRT to PBT to determine which therapy best     minimizes the side effects of treatment.   "
127428|NCT01617148|"     This study will examine the use of Aflibercept in patients with exudative macular     degeneration requiring intravitreal injections. Patients will be followed for 12 months.   "
127429|NCT01617135|"     The purpose of this study is to determine the safety, efficacy and pharmacokinetics following     administration of CVT-301 in treatment of off episodes in Parkinson's Disease patients.   "
127430|NCT01617122|"     This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe and     effective as an antigen used in the evaluation of primary and secondary immune responses.     Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small blood     specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14 days, and     28 days. Blood is collected at intervals following the administration of the bacteriophage     and the number of phage/ml is determined by the agar overlay method using suspension of E.     coli C and serially diluted patient's serum. Phage-specific IgG and IgM are measured by     neutralization assay. Capacity of switch from IgM to IgG is determined.   "
127431|NCT01617109|"     The primary objective of this randomized, double-blind, placebo-controlled trial is to     determine the effect of vitamin D and calcium supplementation (800IU and 2000mg,     respectively) on biochemical indicators of nutritional status and bone health in military     personnel during Army basic combat training (BCT) and Air Force basic military training     (BMT).      The investigators hypothesize that daily supplementation with vitamin D and calcium during     military training will improve vitamin D status, stabilize PTH levels, and result in     improvements in markers of bone health. As a result of the investigators study design, the     findings will provide critically important data regarding the concentration of vitamin D in     blood necessary to stabilize PTH levels and to optimize bone formation during initial     military training.   "
127433|NCT01617083|"     The purpose of this research study is to know if the antibiotic azithromycin, an antibiotic     approved by the U.S. Food and Drug Administration (FDA) for treating infections, improves     symptom severity in children with sudden and severe onset obsessive compulsive symptoms known     as PANS, Pediatric Acute Onset Neuropsychiatric Syndrome, and PANDAS, Pediatric Autoimmune     Neuropsychiatric Disorder Associated with Streptococcus. This study seeks to compare the     effects of placebo vs. azithromycin on Obsessive Compulsive Disorder (OCD) symptom severity     as well as to assess immune risk factors in children with PANDAS/PANS. Obsessions are     repetitive, unwanted thoughts or worries that may be unpleasant, silly, or embarrassing.     Compulsions are repetitive or ritualistic actions that are performed to ease anxiety or     worries. Doctors think these symptoms may be caused or exacerbated by certain infections such     as Streptococcus pyogenes, Mycoplasma pneumonia, Borrelia burgordfi, etc. These infections     commonly cause strep throat, walking pneumonia, and Lyme Disease, among others.      This study will involve a 4 week double-blind, placebo-controlled randomized trial of     azithromycin (Double Blind Phase). At the end of this 4 week trial, the child will be     assigned to azithromycin for 8 weeks (Open Label Phase). At the end of these 12 weeks, a     Naturalistic Observation phase will assess the child's symptom characteristics for up to 40     weeks.      The study hypothesizes that children receiving antibiotic will show significantly greater     overall improvement in severity compared with placebo, and that children with sudden onset of     OCD and whose subsequent course shows dramatic fluctuations will have evidence of immune risk     factors that predisposes to this presentation.   "
127434|NCT01617070|"     This study examines the effect of tetrahydrobiopterin (Kuvan) and Large Neutral Amino Acid     (LNAA) therapy on melatonin and dopamine levels in individuals with Phenylketonuria (PKU).     The investigators hypothesize that Kuvan therapy will improve melatonin secretion and urine     dopamine levels to some extent. However significantly greater responses in melatonin and     dopamine secretions may be observed with combined treatment with Kuvan and supplementation of     LNAA.   "
127435|NCT01617057|"     The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid, Skelid®,     Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis   "
127436|NCT01617044|"     A double-blind randomized controlled trial comparing iron plus vitamin C plus probiotic     (lactobacillus plantarum 299) to iron plus vitamin C plus placebo in correcting the iron     deficiency in children with Restless leg syndrome (RLS) and iron deficiency. One hundred     children with diagnosis of RLS will be recruited over a two- year period.   "
127437|NCT01617031|"     The aim of the study is to evaluate platelet function variations according to the delay since     last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous     Coronary Artery Disease.   "
127439|NCT01617005|"     This observational study will evaluate the safety and efficacy of tocilizumab in participants     with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data     will be collected from each eligible participant initiating tocilizumab treatment over 6     months.   "
127462|NCT01616693|"     The percentage of participants with a serologic immune response (seroconversion or four-fold     rise in rotavirus IgA antibodies) to rotavirus vaccine at 14 weeks of age among infants     receiving zinc or probiotic supplements will be at least 15% higher and significantly better     to that of infants who receive a placebo for zinc or probiotic supplement.   "
127440|NCT01616992|"     Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and     extensive disability in a large group of women int he prime of their productive lives.     Extensive study of the bladder itself has uncovered many abnormalities, but the investigators     do not know if these are the cause or result of the disorder. None of these has led to any     real long-term progress in treatment, so far. The investigators have found that other     autonomic disorders often occur in both the patients themselves and in the family members of     patients with IC/PBS. The investigators therefore propose to determine whether the main     abnormality in IC/PBS actually lies in the autonomic nervous system, rather than the bladder.     The investigators will do this through careful measurements of autonomic function and     sensation in patients who have IC/PBS, both at rest, and under controlled psychological     stress. The investigators will compare their measurements to patients with myofascial pelvic     pain, to know which abnormalities are truly linked to IC/PBS, and which simply reflect the     presence of pelvic pain.   "
127488|NCT01616355|"     The present study tried to integrate all aspects of denture care: patient satisfaction with     the treatment, denture decontamination and base material defects after decontamination     processing.   "
127489|NCT01616342|"     The purpose of this study is to determine the degree to which spinal cord stimulation added     to comprehensive medical management can provide increased relief of chronic pain in patients     with injuries sustained while on active military duty, measured by patient assessments of     pain.   "
127441|NCT01616979|"     During cardiac displacement for off-pump coronary artery bypass(OPCAB) surgery, the presence     of air underneath the displaced heart compromises the transgastric (TG) window for     transoesophageal echocardiography(TOE). The investigators hypothesised that placing a     saline-filled glove would enhance TG transmission of ultrasound and facilitate TOE imaging     for monitoring left-ventricular regional wall motion (LV-RWM). For left circumflex coronary     artery (LCX) grafting in OPCAB surgery (n=13), mid-oesophageal (ME) and TG TOE images are     recorded before cardiac displacement (T control), after displacing and stabilising the heart     (T-displaced), and after placing a saline bag (saline-filled surgical glove) underneath the     displaced heart (T-saline bag). Following data are determined by integrated TG and ME TOE     views (ME+TG) at T-control, T-displaced and T-saline bag: number of readable segments (NRS)     in a 17-segment model; NRSs in basal and mid-TG short axis views; NRS in 5-LV segments of the     LCX territory; the incidence of inadequate monitoring of LV-RWM (NRS < 14/16 except for the     apex in 17-segment model).   "
127442|NCT01616966|"     Vocal cord injuries occur not only during tracheal intubation, but also during surgery and     during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle     relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less     vocal cord injuries than a total intravenous anesthesia with propofol.   "
127443|NCT01616953|"     The purpose of this research is to determine if a patient's own bone marrow tissue can help     regenerate bone in the area of the jaw where an implant will be placed. The name of the     process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be     collected and sent to a laboratory where it will be processed to form more cells. These new     cells will then be transplanted in the regenerative site. The researchers are testing to see     if these cells (BRC) will help form bone. The research will also determine if the implant     will be more stable in the area with new bone growth.   "
127444|NCT01616940|"     The purpose of this study is to determine whether an enhanced peer intervention is effective     in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.   "
127445|NCT01616927|"     Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst     formation in both kidneys, in most patients leading to end stage renal disease. It is the     most common hereditary renal disease with a prevalence of approximately 1 in 1,000 persons.     The majority of patients also have progressive cyst formation in the liver, leading to pain,     gastrointestinal discomfort and sometimes the need for liver transplantation. At present     there is no proven therapeutic intervention to slow the rate of disease progression in human     ADPKD. The development of renoprotective treatments that are well tolerated, is therefore of     major importance.      In this respect, somatostatin analogues are promising for especially polycystic liver     disease, but also for the renal phenotype. However, the studies that have been performed thus     far with these agents, were underpowered and of too short duration to reach a definitive     conclusion on the potential reno- and hepatoprotective efficacy of somatostatin analogues.     Therefore, the present study is designed as a randomised clinical trial with sufficient     duration of follow-up to investigate whether the somatostatin analogue Lanreotide slows     progression of polycystic kidney and liver disease in ADPKD-patients.      To this end, 300 ADPKD patients, aged 18-60years, with an eGFR 30-60 ml/min/1.73 m2) will be     randomized 1:1 to standard care or monthly subcutaneous lanreotide injections on top off     standard care. These 300 subjects will go through 15 study visits in 3 years and 1 follow up     visit. During these visits, questionnaires will be filled in, physical examinations will be     performed, blood will be drawn and urine collected. After study completion, rate of renal     function decline in lanreotide treated subjects will be compared to that of subject who     received standard care.   "
127446|NCT01616914|"     Delirium has been associated with clinical outcomes in critical care setting. However, its     subclinical form has not been investigated. The investigators aimed to establish the     association of subclinical delirium with outcome.   "
127459|NCT01616745|"     The purpose of this study is to elucidate phenotypic, clinical, and genetic characteristics     of Korean Nontuberculosis Mycobacteria (NTM) patients.   "
127460|NCT01616732|"     The investigators hypothesise that testosterone therapy will synergize with dietary     intervention to achieve weight loss. Obese men will receive diet, and be randomised to either     testosterone therapy or placebo. Primary outcomes will be weight and body composition.   "
127461|NCT01616719|"     DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for     Cervical Degenerative Disc Disease. This study is being conducted to determine the     effectiveness of the graft, and to find out whether or not it provides better results or     faster healing than traditional ways of performing surgery for Cervical Degenerative Disc     Disease.   "
127463|NCT01616680|"     The purpose of this research is to test the safety and efficacy of brentuximab vedotin in     patients with acute skin graft-versus-host disease (GVHD)   "
127447|NCT01616901|"     The decision to extubate a patient after acute respiratory failure is based on clinical     observation and measurement of pulmonary mechanics. Current extubation criteria(tidal volume,     respiratory frequency...) lack of specificity. The best way to evaluate and predict patients     breathing abilities after extubation is to challenge him to a spontaneous breathing trial     (SBT) with endotracheal tube in place immediately before extubation to predict the patient's     ability to breathe spontaneously after extubation. The intention is to approximate, while the     patient is still intubated, the work of breathing that will be required of the patient after     extubation. Different approaches of ventilatory settings are currently used for the     preextubation SBT, whether pressure support ventilation (PSV), continuous positive airway     pressure (CPAP), or spontaneous ventilation through an endotracheal tube (T piece), all     supported by literature with different benefits. To the investigators knowledge, few studies     define which mode of ventilation most closely approximates the work of breathing during     spontaneous respiration after extubation, and none have studied a specific population of     obese patient in respiratory weaning. The main objective of the investigators study is to     determine, between five different SBT, which one is the best to approximate the work of     breathing of obese patient after extubation.   "
127448|NCT01616888|"     The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting     balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.   "
127449|NCT01616875|"     26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4     cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given     intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the     overall response rate and to determine whether this approach warrants further research of a     phase II/III study.Participation in 2 sub studies will also be offered to the participants.        1. Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after          cycle 1 and cycle 3.        2. A pilot sub study involving the circulating tumour cell concentration from blood samples          taken at baseline, prior to each cycle of chemotherapy and prior to surgery   "
127450|NCT01616862|"     Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung     infections in people with CF. Many young children do not have Pa in their lungs but will     become infected as they get older. The investigators want to learn more about how Pa is     passed from person to person, especially to someone with Cystic Fibrosis (CF).   "
127452|NCT01616836|"     The aim of this study is to determine the best method of pain control that will help with     rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain     control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is     placed beside the nerve that provides sensation to a large part of the knee and local     anesthetic infused after surgery causing numbness to the surgical site. A single injection     method also exists and may provide similar benefits. Both methods require training and can     result in side effects such as temporary weakness (while the local anesthetic is still     working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the     joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause     weakness and can be done quickly at the end of surgery. It is unknown if the pain control     provided by LIA is as good as that of FNB. This study will compare the femoral nerve block,     continuous femoral nerve block and LIA technique to determine which provides better pain     relief after TKA.   "
127453|NCT01616823|"     In optimally managed HIV+ women with undetectable viral loads, who are on HAART and also     receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the     length of time of rupture of membranes.   "
127454|NCT01616810|"     The purpose of this study is to determine the validity of a screening tool which has been     designed to detect the presence or absence of lower urinary tract symptoms in the general     female population.   "
127455|NCT01616797|"     The research proposes to use an innovative solution to shape brain circuits that support     executive function and emotion reactivity -using targeted neurobehavioral intervention.   "
127456|NCT01616784|"     For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal     while avoiding hypoglycaemia but this is severely limited by the relative crudeness of     current insulin delivery in comparison with the physiology of the β-cells which secrete     insulin. Insulin is generally administered by multiple injections MDI with the dose adjusted     according to eating and exercise. Insulin can now also be administered using a pump (CSII),     which is a device, roughly the size of a mobile phone and containing sufficient insulin to     supply both the needs of basal metabolism throughout the day, and the boluses which have to     cover meals. The use of CSII is expensive compared to injections, but there are important     potential benefits which include improved glycaemic control, reduced risk of hypoglycaemia     (low blood sugar) and a more flexible lifestyle and better quality of life. There have been     no trials in adults that have compared CSII treatment with MDI where the same structured     training in intensive insulin therapy has been given, so the precise benefit of the pump     technology is still unclear. There is a need to establish this, and identify patients who     benefit the most so that the Department of Health can calculate the proportion of adults that     would benefit from CSII therapy and so ensure that commissioning bodies provide the necessary     reimbursement. The aim of the trial is therefore to establish the added benefit of CSII     therapy over multiple injections on glycaemic control and hypoglycaemia in individuals with     Type 1 diabetes receiving similar high quality structured training (Dose Adjustment For     Normal Eating:DAFNE) in insulin therapy. Additional assessments will include effects on     quality of life and cost effectiveness.   "
127457|NCT01616771|"     The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct     laryngoscopy in patients whose airway management are anticipated difficult (C&L grade ≥3) by     comparing the laryngoscopic view. Also, the investigators compared the effectiveness of     smaller-size blade of GVL (GVLs) with standard blade of GVL selected by patient's weight     (GVLw) in the same patients.   "
127458|NCT01616758|"     The primary efficacy analysis will be the clinical benefit at 6 months as measured by a     modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary     endpoints of objective response rate, progression free survival, time to progression,     duration of response, effects on physical function, and effects on tumor progression in women     with Androgen Receptor positive breast cancer will also be assessed.   "
127464|NCT01616667|"     The aim of this study is to investigate the clinical outcome of the two different, but widely     used, surgical approaches (Posterior approach and Lateral approach) of primary total hip     arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main     study and two sub-studies. The main study investigates the patient-reported outcome measures     (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the     level of physical function and pain within the first 3 month after surgery, and ii)     investigate the potential difference the two approaches have on gait-patterns and maximal     isometric hip-muscle-strength, within the first year after surgery. Both approaches are     described with potential drawbacks. Posterior approach has a higher risk of dislocation of     the prostheses and revision due to dislocation compared with Lateral approach. Contrary,     Lateral approach is described with the potential drawbacks of pain, lower physical function,     gait abnormalities and muscle weakness, leading to less satisfied patients. However,     according to a Cochrane analysis from 2004 concludes, more investigation is needed to     determine the extent of differences.   "
127466|NCT01616641|"     Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in     the physical examination of patients with RA, the joints in the area of the jaw and neck may     also be affected in this disease and have their involvement usually underdiagnosed. There are     few studies evaluating the incidence of orofacial alteration in the examination as well as     the correlation between bite force (BF) and clinical and functional parameters in these     patients. The aim of our study was to chacacterize the orofacial alterations in RA patients,     correlate the results of the orofacial evaluation with clinical and disease activity     parameters, and correlate the bite force with the hand strenght.   "
127467|NCT01616628|"     Identifying effective strategies for improving healthier eating for low- income populations     is both a clinical challenge and a public health priority. Approximately one-fifth of the     children in the United States are either overweight or obese. Obesity is even more common in     low- income populations as are other related health conditions such as diabetes, hypertension     and cardiovascular diseases.      The consumption of fruits and vegetables is strongly associated with the prevention and     management of obesity and diabetes and cardiovascular diseases. Overall, only about 38% of     Americans consume the recommended servings of vegetables and only 23% consume the suggested     amount of fruit. Close to 20% of low- income households do not purchase fruits and vegetables     at all.      The proposed research offers an opportunity to investigate a different approach to incentives     for healthier eating in a low-income urban population. Specifically, this study will examine     a rewards-based incentive for fruit and vegetable purchases with rewards based on cumulative     purchases. Previous studies have shown that incentives may be an effective means of promoting     behavior change. The proposed study will provide essential data about the impact of targeted     incentives to promote acquisition of fruits and vegetables by individuals living in     households with young children. The investigators plan to design a subsequent, larger study     based on the results of this study. In the proposed study, the investigators will     specifically contribute to this knowledge by investigating the effects of rewards-based     incentives that provide delayed reinforcement.      SPECIFIC AIMS AND STUDY HYPOTHESES      The goal of this study is to investigate whether incentives to low-income families to     encourage purchase of healthier foods can be used to help stem the tide of childhood obesity.     Although this study is a randomized trial, a major function is collecting data to be used in     the design of a larger randomized controlled trial comparing two different interventions     using incentives to promote healthier eating in low-income communities. The investigators     will test a supermarket gift card with rewards based on purchases of fruits and vegetables     during the intervention periods. The specific objective is to determine whether that     incentive system—(where the rewards can be used to purchase anything in that supermarket)     increases healthier food purchasing practices by low-income families. The primary outcomes     are: number of servings, and percent of total food dollars spent on fruits and vegetables     (fresh and frozen). The primary hypotheses are:        1. Households in the intervention group will purchase more fruits and vegetables than          controls per week, both during: a) each intervention phase as compared to the baseline          period and b) in the follow up phase compared to the baseline period. (Between group          comparisons over time of intervention versus control group)           The secondary hypotheses are:        2. Households in the intervention group will purchase more fruits and vegetables per week          both during: a) each intervention phase as compared to the baseline period and b) in the          follow up phase compared to baseline. (Within group comparisons over time)   "
127468|NCT01616615|"     To establish wether a prophylactic intervention from first trimester with low-dose of aspirin     improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by     abnormal uterine artery Doppler at first trimester   "
127469|NCT01616602|"     For obese patients, a randomized trial aimed at determining whether colonoscopy performance     and patient comfort is improved if a patient is in the prone position (lay on their abdomen)     versus the traditional left-sided position.   "
127470|NCT01616589|"     The purpose of this research is to determine if saliva samples can be used as an alternate     sample type to test for fragile X. By using saliva instead of blood, it would be easier for     patients to have fragile X testing.   "
127471|NCT01616576|"     The purpose of this study is to compare a new sound processing strategy to the current sound     processing strategy.   "
127472|NCT01616563|"     The overall objective of the CHANGE initiative is to change the delivery of care in primary     care clinics to treat disease by reducing reliance on drugs and hospitals through the     promotion of scientifically validated nutritional concepts and exercise. Specifically, the     objective is to identify patients from primary care clinics with metabolic syndrome who are     not morbidly obese and use diet and exercise interventions to reverse the changes, reduce     reliance on pharmacotherapy and prevent progression to diabetes and cardiovascular disease.   "
127473|NCT01616550|"     The purpose of this study is to assess the quality of postoperative pain management in a     Canadian teaching hospital following thoracic surgery.      Hypothesis: Postoperative pain management following thoracotomy or thoracoscopy is still     suboptimal despite the evidence that adequate pain relief improves outcome.   "
127474|NCT01616537|"     Background Patient satisfaction with or acceptance of care assessment is increasingly taken     into account in oncology. Most cancer and other critically-ill patients require a     totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a reservoir     connected to a central venous catheter, which may or may not be valved. It is impossible to     estimate the number of CVC used in oncology. However, some authors claim that, in 2005, over     7 million CVCs were placed in the United States in both chronic and acute care. Although many     patients fitted with a CVC are able to undertake activities which are hindered with other     external vascular access devices, they are often physically or psychologically anxious about     their device. To our knowledge, no validated questionnaire measuring patient acceptance of     and satisfaction with their CVC has been reported in the literature. Based on these     observations, the aim of our study was to develop and to validate a French-language     questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted     Central Venous Catheter) assessing patient satisfaction with and acceptance of their CVC.     QASICC is designed as a multi-dimensional, self-administered questionnaire comprising     approximately 30 items related to the use, appearance and pros and cons of the device as well     as quality of life as perceived by patients using one for treatment.      Objective The purpose of the study is to validate a French-language self-administered     questionnaire (QASICC) designed to evaluate patients' satisfaction and acceptance concerning     their totally-implanted central venous catheter: confirmatory validation of questionnaire     psychometric properties.      Study Design This is a prospective, multicenter, open study.      Primary Outcome Measures:      Questionnaire's 27 items tested on 990 patients to confirm QASICC internal structure:        -  Items quality        -  Dimensional structure        -  Dimensional consistence        -  Measure accuracy        -  Measure reliability        -  Sensitivity to change   "
127475|NCT01616524|"     The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon     Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus     Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to     24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin   "
127477|NCT01616498|"     This pilot study is designed to determine the relationship between intra-myocellular lipids     and muscle contractility in fibers from obese and non-obese older adults. Obese participants     are being recruited for an on-going weight loss intervention study and this application seeks     approval to recruit and enroll a lean comparison group of non-obese older adults. The primary     goal of this study is to characterize the contractile properties of single muscle fibers and     whole muscle in healthy, non-obese individuals under the same recording conditions the     investigators used for the obese population to begin to determine whether fat infiltration     accounts for diminished force.   "
127478|NCT01616485|"     The objective of this study is to evaluate the hemodynamic response to a sublingual dose of     glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.   "
127479|NCT01616472|"     The study is designed to assess the association between steroid exposure and five potentially     steroid-related adverse events within a cohort of individuals with systemic lupus     erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i)     diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis     that is attributable to cumulative corticosteroid exposure in SLE patients. The study will     consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases     will be incident SLE cases who have developed one of the case outcomes (diabetes,     hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular     necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary     exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of     exposure to steroids. The extent of the risk associated with steroids will be explored     through modeling of the relationship and through calculation of attributable risks of     exposure (number of cases associated with the highest exposure quartile of each primary     exposure).   "
127480|NCT01616459|"     The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two     formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as     3-dose primary vaccination during the first 6 months of life followed by a booster dose in     the second year of life. To comply with the routine infant immunisation program, the licensed     GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants     with the pneumococcal study vaccines.   "
127481|NCT01616446|"     The purpose of this study is to evaluate whether there are differences in the     pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease     in children.   "
127482|NCT01616433|"     Older adults are at high risk for loss of independence because of age-related chronic health     conditions. Of these chronic conditions, arthritis accounts for the largest proportion of the     disability in the community. The investigators propose to target older adults who have     self-reported arthritis or joint pain for dissemination of a disability prevention program.     The program will be a collaborative effort of the Arthritis Foundation, the investigators     Prevention Research Center staff and other key partners in the community. The project will     develop information needed to provide guidance for implementation of the investigators     intervention by other agencies and organizations. As a major thrust of the investigators CDC     Prevention Research Center, the investigators have developed a comprehensive program focused     on preventing disease and disability in older adults: the 10 Keys to Healthy Aging. Each of     the 10 Keys disseminates proven approaches and current recommendations for prevention in     older adults, focusing on age 65+ but also addressing age 50-65 years. The overall objective     is to determine if an integrated evidence based exercise intervention (AFEP) combined with     health education on preventive practices for older adults (10 Keys) is more effective for     improving mobility and risk factors for mobility disability and use of preventive services     compared to exercise alone (AFEP). The investigators will also propose to evaluate the impact     of geographic location on outcomes and overall sustainability of the program.   "
127483|NCT01616420|"     The main purpose of this implementation science study is to find out if providing aPS at 18     different Ministry of Health (MOH) VCT clinics in Kenya works and is cost-effective. This     would enable co-investigators in the Kenyan MOH to justify funding to scale-up these     services.      The primary aim of the study is to find out whether providing aPS to sexual partners of newly     tested HIV-infected individuals can result in more sexual partners getting counseled and HIV     tested and linked to HIV care programs for initiation of ART if appropriate. The     investigators hypothesize that aPS will increase rates of case-finding, linkages to care, and     ART initiation and will not result in social harm.      The second aim is whether aPS is cost-effective in the Kenyan setting. The investigators will     estimate how much it costs (when compared to standard methods) to identify and link     HIV-infected persons into care. The investigators will also determine how successful aPS is     at preventing future HIV transmission events and other outcomes associated with untreated HIV     infection. The investigators hypothesize that HIV prevalence among partners in the immediate     aPS arm will be high enough to make this approach cost-effective from the payer and societal     perspective.      Finally, with the Kenya MOH, the investigators want to establish a nationwide monitoring     system to evaluate why Kenyans are testing for HIV. In the future, when aPS is rolled out     nationally, this will help Kenyan public health officials define the contribution of aPS to     HIV case-finding. The investigators hypothesize that the proportion of newly tested     HIV-infected individuals who report testing because of known exposure to a person with HIV     will represent a significant proportion of new cases and the investigators will be able to     identify places in Kenya where aPS will have the greatest impact on HIV treatment and     prevention.   "
127484|NCT01616407|"     The purpose of this study is to assess and compare the effects of a single dose of     3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social     cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective     perception for positive and impairs perception for negative emotional stimuli compared to     placebo or MPH.   "
127485|NCT01616394|"     The aim of the study is to evaluate the value of postoperative troponin in the prediction of     mid term and long term mortality and morbidity in children with congenital heart disease     undergoing cardiac surgery.   "
127486|NCT01616381|"     This protocol describes a 2-arm randomised controlled pilot study assessing the tolerance,     safety and efficacy of sildenafil compared to control. The hypothesis is that sildenafil will     be well tolerated and efficacious in patients with chronic heart failure (NYHA class II and     III) with evidence of systolic dysfunction (EF ≤40 %) and secondary pulmonary hypertension     (SPAP >40mmHg).      Patients that satisfy the inclusion criteria will be randomized to sildenafil (40mg x 3) or     placebo therapy for 6 months in a 2:1 blinded fashion. The placebo group will be compared to     the active therapy group and analysed for differences in the main study end-points Patient     Global Assessment and 6-Minute Walk Test.      The study will also assess safety, tolerability, symptoms and quality of life.   "
129383|NCT01591603|"     The study will investigate the difference in success rate between popliteal peripheral nerve     catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.   "
127487|NCT01616368|"     The investigators propose to study the effect of mindfulness training on the eating behaviors     and dietary intake of overweight or obese persons. Mindfulness skills training involves     bringing non-judgmental attention to thoughts, emotions and bodily sensations - including     hunger and satiety cues. It is hypothesized that as subjects advance through the 8-week class     series, developing their capacity for mindfulness and in effect learn to pay attention to the     sensations, assumptions, cognitions, and beliefs that underlie their eating behaviors, that     their eating behaviors will improve. Specifically, the investigators hypothesize that 1)     there will be significant improvements in the areas of uncontrolled and emotional eating, 2)     there will be significant decreases in total caloric intake and significant increases in     fruits and vegetables, and 3) there will be a positive significant relationship between the     frequency/consistency of mindfulness practice and improvements from baseline to follow-up     measures.   "
127490|NCT01616329|"     Alloantibodies can lead to serious clinical consequences and logistic problems like obtaining     properly and timely matched blood for the patients who do develop these antibodies.     Prevention of such serious events is possible by extended matching and typing of donor's     blood against the patient's for all the possible antigens, but this process is cumbersome and     costly. Identifying a high risk group will be a feasible first target for advanced matching a     big step forward, and the aim of the investigators study. The aim of the project is to     examine the association between clinical, environmental and genetic characteristics of the     recipient of erythrocyte transfusions and the risk or resistance to immunization against     erythrocyte alloantigens that he/she was exposed to during that transfusion episode.   "
127491|NCT01616316|"     Subfascial approach method in thyroidectomy maybe result in better quality of life than     conventional approach method in thyroid disease patients   "
127492|NCT01616303|"     This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of     oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when     combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy     (carboplatin and paclitaxel) alone in female patients with advanced ovarian cancer. This     study is to confirm previous results that showed oregovomab was able to help the body to     produce an immune response to CA125 (a target that has been identified on ovarian cancer     cells) in patients with stage III-IV ovarian cancer when they were receiving chemotherapy for     their disease. The primary aim of the study is to see how well these patients with advanced     ovarian cancer make an immune response to CA125 by using a specific test (enzyme-linked     immunospot (ELISPOT) assay) of the patient's blood. The study will also look at the side     effects of the oregovomab, other immune response parameters, how well the patients respond to     the treatment of their disease (how long it takes to show that their disease has progressed     and how long these patients survive overall).   "
127493|NCT01616290|"     The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the     adventitia of arteries following successful angioplasty (PTA).   "
127494|NCT01616277|"     The purpose of this study is to determine if the study drug, PF-06252616 is safe and well     tolerated when given to adult healthy volunteers.   "
127495|NCT01616264|"     Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph     scan three-dimensional reconstruction method for the measurement of the TB pleural effusion     volume in clinically stable patients.   "
127496|NCT01616251|"     Background:        -  New Nordic diet guidelines advocate a reduction in consumption of protein from animal          sources such as beef and pork, due to environmental concerns.        -  Instead, intake of protein from vegetable sources such as legumes and pulses should be          increased.        -  A previous study showed that a meal enriched with vegetable protein increased the          subjective sensation of satiety and decreased hunger and ad libitum energy intake (EI)          compared to animal protein.        -  This study did, however, not document that vegetable protein per se is more satiating          than animal protein as the vegetable meal had higher fiber content. Fiber is a likely          confounder.        -  The protein from egg is sparingly investigated in relation to appetite. Few studies have          found that eggs have a high satiety index but further investigation is needed.      Objective:      - To examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and     ad libitum energy intake) compared to isocaloric meals enriched with either red meat or egg     with similar distribution of macronutrients and content of dietary fibers.      Design:      Single-blind randomized 4-way crossover meal study      Subjects:      33 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2). Expected completers: n=30.      End points:        1. Subjective appetite (VAS) (every 30 min for 3 hours)        2. Ad libitum EI (3 hours after lunch test meal)   "
127497|NCT01616238|"     The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to     carry out a prospective, non randomised multi-arm study (including a choice of regimen     intensity) to investigate the safety, tolerability and feasibility of a standardised therapy     protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic     standard of care upon which trials of novel therapies will be based in future. The design of     the study will enable collection of a comprehensive dataset regarding the clinical outcome,     Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously     completely uncharacterised population, thus providing the essential platform for designing     future randomised advanced phase studies in which new therapeutic approaches and novel     therapies can be prospectively investigated.   "
127498|NCT01616225|"     This study (the Adjuvant Growth Hormone Study) is being done to see the effects of adding     Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF).     Growth Hormone is a protein that your body normally produces. Growth Hormone can act on     several different organs, including the ovaries, where eggs are made. From evidence gathered     from studies done by fertility doctors over the years, researchers believe that women who     have not become pregnant through IVF in the past might have better results if they go on a     course of Growth Hormone during the IVF treatment. However, more research needs to be done to     confirm whether adding Growth Hormone is beneficial and also to find out the best time to     start Growth Hormone treatment during IVF.      We hope that our Adjuvant Growth Hormone study will help answer these questions.   "
129695|NCT01587495|"     The investigators are doing this study to learn more about the dosing and safety of ertapenem     in women with suspected serious infections less than 42 days from the delivery of their     infant.   "
127499|NCT01616212|"     The purpose of this study is to evaluate two brief, sustainable interventions for a sample of     280 adolescents charged with an initial drug-related offense: Motivational Enhancement     Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents.     Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related     offenses, treatment entry, and other areas of individual and family functioning.      It is expected that the combined MET+PW interventions will be more effective than a     treatment-as-usual intervention (drug education group) for adolescents with parents not     participating in PW.   "
127500|NCT01616199|"     The purpose of the phase 1 portion of the study is to determine the maximally tolerated dose     (MTD) or recommended dose (RD) and the safety/tolerability of PX-866 in combination     vemurafenib in patients with any advanced BRAF-mutant cancer.      The purpose of the phase 2 portion of the study is to compare progression free survival     (PFS), antitumor activity (response rate), disease control rate (DCR), and the safety and     tolerability of PX-866 in combination with vemurafenib vs. vemurafenib alone in patients with     advanced BRAF-mutant melanoma at the doses recommended from Phase 1.   "
127501|NCT01616186|"     This is a phase II trial that follows the completion of the phase I UCSF trial of everolimus     and sorafenib for Renal Cell Carcinoma (RCC). This trial will be for patients who have not     had treatment for RCC before. This trial will have 2/3 patients getting everolimus/sorafenib     treatment and 1/3 getting sunitinib, an FDA approved RCC drug. All three drugs are approved     for advanced RCC when used individually, the combination of everolimus and sorafenib for RCC     is not approved by the FDA.   "
127502|NCT01616173|"     Patients scheduled to have foot and ankle surgery will typically receive a single shot     sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal     post-operative analgesic plan. The investigators are investigating the use of perineural     dexamethasone together with local anesthetics can improve the quality of recovery for     patients receiving sciatic nerve blocks for foot and ankle surgery.   "
127503|NCT01616160|"     Aim 1: To assess steroid sensitivity to mometasone furoate (MF) in cultured nasal polyp     explant tissue in vitro.      Aim 2: To assess steroid sensitivity in vivo in each subject by comparing symptom scores,     nasal endoscopic findings before and following 4 weeks of treatment with mometasone furoate     nasal spray (MFNS) and by comparing tissue immunohistology in NP biopsies pre- and     post-treatment withA MFNS.      Aim 3: To characterize the molecular signature of gene mRNA expression in steroid-sensitive     and steroid-resistant NP using microarray on NP tissue pre- and post-MFNS treatment.      Hypothesis 1: Genes that regulate apoptosis are dysregulated in nasal polyp (NP) inflammatory     cells, epithelial cells and smooth muscle actin myofibroblasts leading to persistence of     inflammatory cell infiltration and abnormal epithelial and myofibroblast cellular     proliferation. These can be corrected by mometasone. Apoptosis-regulating genes that cannot     be corrected by mometasone are upregulated in steroid-resistant NP.      Elucidation of this dysregulation may prove insightful in understanding the mechanism of     action of mometasone in NP and identifying potential molecular targets that will increase     steroid sensitivity or, conversely, overcome steroid resistance.      Hypothesis 2: There is a molecular signature of gene expression in NP that signifies steroid     sensitive NP (SS-NP). This signature is altered in steroid resistant NP (SR-NP).      Elucidation of differences in the molecular signature of SS-NP versus SR-NP before and after     treatment with mometasone furoate (MFNS) will provide novel insight into treatment of NP with     steroids.   "
127504|NCT01616147|"     This randomized, controlled trial is proposed to study the effect, in a cohort of racially     and ethnically diverse group of overweight and obese pregnant women, of an Intensive     Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help     participants achieve and maintain changes in dietary intake and physical activity habits     compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers'     post-delivery weight retention. The hypothesis is that the percent body fat at birth will be     significantly less in offspring from ILI mothers than UC mothers.   "
127505|NCT01616134|"     Korean red ginseng (KRG) is popular worldwide since it is believed to contain ingredients     with a variety of health enhancement effects. Several in vitro studies and animal studies     showed that ginseng has anti-obesity, anti-diabetic and anti-metabolic disease effects.     Several studies involving type 2 diabetes mellitus (T2DM) patients reported that     administration of KRG for 12 weeks resulted in positive effects on the maintenance of sugar     control effect and improvement of insulin resistance Although there is evidence to suggest     that KRG could efficacious reduction in postprandial glycemia, the benefits of long-term KRG     in healthy individuals on insulin sensitivity has not yet been established. Therefore, we     investigated whether KRG affected insulin sensitivity in healthy overweight or obese Korean     subjects without overt diabetes.   "
127506|NCT01616121|"     It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will     develop acute heart failure during their hospitalization. Currently, the investigators have     no reliable parameter for prediction of evolving acute heart failure in such a group of     patients. As a result, the investigators have no way of preventing acute heart failure.     Treatment of these patients only begins after appearance of clinical signs of acute heart     failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of     evolving acute heart failure. This study will attempt to address whether preemptive lung     impedance-guided therapy may prevent the development of overt acute heart failure and improve     their clinical outcome.   "
127507|NCT01616108|"     This study seeks to determine if bupivacaine injection of eye muscles can make them stronger     and stiffer, and thereby correct the position of eyes that are turned in or mis-aligned, a     condition generally termed strabismus. It seeks further to find out the different effects of     various concentrations or formulations of bupivacaine, and whether addition of Botox to other     eye muscles can add to the effect of bupivacaine and enhance the correction of strabismus.   "
127534|NCT01615757|"     The study will be conducted in the Department of Medical Oncology and Department of     Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in     complete remission after induction chemotherapy will be enrolled into the study and will be     further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3     cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study     protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the     relapse free survival and overall survival as well as time to relapse and toxicity /treatment     related morbidity.   "
127508|NCT01616095|"     This study is designed as a follow up study to that performed in 2005.      In the Baseline study (2005) extensive clinical whole body metabolic phenotyping was combined     with in depth molecular and cellular biology analyses aimed at investigating the adipose     tissue morphology as well as metabolic and inflammatory phenotypes in the adult GHD patients.     Results published in (Ukropec et al., 2008)      In this study identical endpoints will be investigated with the same methodology and within     the same population; in order to seek relevant answers to questions on how the 6-yrs of rhGH     therapy affects the        -  whole body insulin sensitivity        -  energy expenditure        -  body fat distribution        -  hepatic and skeletal muscle lipid content;      as well as how it influences the adipose tissue        -  endocrine,        -  metabolic &        -  inflammatory phenotypes.      The strength of the planned study lies in the extensive whole body and adipose tissue     phenotyping before and after the 6-year rhGH replacement therapy, that allows to determine     the long-term effects of rhGH replacement therapy in GHD adults.      Envisaged weakness is the limited size of the population; GHD adults (n=20); controls [age     BMI and gender matched] (n=20). This, however, reflects [is limited by] the complexity of the     study protocol as well as the stringency of the inclusion criteria.      The clinical data obtained by methods of - integrated physiology would provide an excellent     interpretation background for molecular-genetic studies at the tissue (adipose tissue) and     cellular (adipocytes) level. Integration of the two could bring a new quality in the     investigators understanding of metabolic derangements present in GHD, and will allow     extending the investigators knowledge on the mechanisms of the long-term rhGH-therapy-induced     improvement on body composition, metabolic health and the cardiovascular risk.   "
127509|NCT01616082|"     The purpose of this study is to better understand the different ways our bodies burn fat     which may be important for obesity, diabetes, and cardiovascular disease.   "
127510|NCT01616069|"     This is a double blind randomization study, assessing hemodynamic response in patients who     underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using     intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be     batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan     will be assessment.   "
127512|NCT01616043|"     The healing of full thickness skin defects treated with a split thickness skin graft (STSG)     is frequently associated with excessive scarring and contraction. The psychological burden of     poor cosmesis of these scarred regions as well as functional problems due to skin tightness     and decreased joint mobility cause a very significant morbidity in these patients.     Application of a dermal substitute underneath the split skin may improve the quality of the     scar. Glyaderm is a dermal substitute derived from human skin and due to the elastin in this     substitute it will contribute to a long term improvement of pliability and function and a     better esthetic outcome.      The main objective is to evaluate the difference in scar quality, after skin restoration of     full thickness defects treated with Glyaderm® and STSG versus STSG alone. Secondary     objectives are: to evaluate the percentage of Glyaderm® take before application of     autografts, to compare healing time and percentage of autograft survival and bacterial load     in full thickness defects treated with Glyaderm® and STSG versus STSG alone, and to conduct a     concurrent cost-effectiveness and health related quality of life study (i.e. cost utility     analysis).      The study is an interventional, prospective, randomized and controlled interactive web based,     study in a multicentre setting. Patients with full thickness burn wounds or full thickness     skin defects will be evaluated before enrolment. A total of 120 patients will be included.      All included patients will undergo full thickness removal of the burned skin or adequate     debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol     preserved allografts for wound bed preparation. At the second operation, 5-7 days after the     first operation, the allografts are removed. If the wound bed is not suitable for grafting,     additional wound bed preparation with allografts is required until the wound bed is     satisfactory. If the wound bed is suitable for grafting, the patient is randomized to the     Glyaderm® group or the control group. The wounds of the patients randomized to the Glyaderm®     group are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin     STSG. In the control group, the wounds are immediately covered with a thin STSG.      Up to one year after complete wound closure, patients are followed-up for scar evaluation and     quality of life.   "
127513|NCT01616030|"     Patients treated surgically for a hip fracture have a need of rehabilitation for the regain     of former functional skills. Despite an optimized fast track in-hospital rehabilitation     program it has been found that patients with hip fracture within 2 weeks after the hip     fracture loose more than half of their muscle strength in the fractured limb compared to     non-fractured limb. New studies including patients with total hip arthroplasty and strength     training applied early after surgery has shown promising results regarding prevention of loss     of muscle strength. No similar study has been found including patients with hip fracture.      The purpose of this study is to examine the feasibility of progressive knee-extension     strength training of the hip fractured limb, starting Day 1 after surgical treatment for a     hip fracture and proceeded every weekday during their hospital stay.      The study will include 20 patients surgically treated for a cervical hip fracture and 20     patients surgically treated for an intertrochanteric or subtrochanteric fracture. All     patients are admitted from their own home. Age 60 years or older.   "
127514|NCT01616017|"     Cardiac output (CO) is an important hemodynamic variable in the management of critically ill     patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential     complications and there is increasing interest in less invasive methods of measuring CO. This     study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution     (COUD).   "
127515|NCT01616004|"     The purpose of this study is to determine whether N2O (laughing gas) has an antinociceptive     effects in healthy volunteers.   "
127516|NCT01615991|"     Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is     considered a reliable and easy-to-perform therapy without harmful side-effects for the     treatment of inflammatory joint disease in many countries.      The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide     synovectomy are appropriate therapeutic interventions in patients with persistent active     synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to     systemic therapy and intra-articular corticosteroid injections.      The primary objective will be to assess the safety of an intra-articular administration of     Yttrium-90 citrate colloid or Rhenium-186 sulfide.      The secondary objective will be to assess the efficacy on synovitis.   "
127517|NCT01615978|"     This trial is conducted in Japan. The aim of this trial is to assess the safety after     multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2     diabetes.   "
127518|NCT01615965|"     The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes     of patients with prostate cancer by quantitative polymerase chain reaction and its impact on     progression-free survival.   "
127519|NCT01615952|"     Blockade of the brachial plexus using a supraclavicular approach provides excellent     anesthesia for upper extremity surgery. The most serious complication specific to this block     is pneumothorax. Subsequent modifications of this block including the use of ultrasound have     lowered the risk from 6% to <1%. Case reports remain and authors have described certain     factors and strategies to reduce this risk. Most texts and journals describe the patient in a     supine or semi-sitting position during the block. At the investigators institution the     investigators perform the block in a semi-sitting position to facilitate needle tip     visibility with ultrasound. The investigators plan to obtain ultrasound anatomic measurements     in three different positions (supine, semi-sitting, sitting) using patients consented for     supraclavicular nerve blocks.   "
127521|NCT01615926|"     Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF) signs     and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg     swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight     gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations     every year, resulting in an enormous public health burden. Approximately 1/3rd of patients     will either be re-hospitalized or die within three months, and the resultant financial costs     are large. As such, improving outcomes for AHF patients is critically important. Shortness of     breath is the most common reason why patients with AHF present to the ER. As such,     understanding how severe this symptom is, how much it improves with current treatments is     very important to both patients and physicians. The purpose of this study is to determine the     degree to which your shortness of breath improves during the first few days of     hospitalization and its association with how fast you are breathing.   "
127522|NCT01615913|"     This study is to explore the optimization of anti‐onychomycosis patch with various     formulation contents (three patch groups: 3%, 6% and 8% of terbinafine (contains 3‐mg, 6‐mg     and 8‐mg/patch terbinafine, respectively) combined with fixed 2% ketoconazole (contains 2‐mg     ketoconazole/patch) and its safety profile.   "
127523|NCT01615900|"     The main objective of this study is to optimize the coverage of renal transplant patients     thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney     Transplant Failure Score), associated with teleconsultations.   "
127524|NCT01615887|"     Amphetamines have been shown to improve cognition but its use is limited due to its side     effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been     safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The     investigators hypothesize that lisdexamfetamine may improve cognitive abilities in MS     patients with documented cognitive dysfunction. Because lisdexamfetamine is a stimulant its     positive effects should be observed primarily in the domains of processing speed and working     memory. The investigators therefore propose a study in which the primary objective will be to     assess the efficacy of lisdexamfetamine in improving attention and processing speed in MS.     The secondary objectives will be (a) the assessment of the safety and tolerability of     lisdexamfetamine in the MS population, and (b) to test for effects of the drug on other     cognitive domains, depression, and self and informant reports of cognitive and executive     function demanding activities and behaviors.   "
127525|NCT01615874|"     The purpose of this study is to assess the effect of one of five possible study medications     used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years     with persistent asthma.   "
127526|NCT01615861|"     The objective of this study is to evaluate clinical outcomes following sub-2 mm     micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is     evaluated in two Phases        -  V4 (6M) endpoint: primary analysis        -  V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis   "
127527|NCT01615848|"     Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine     syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The     elevated insulin characteristic of PCOS is likely to play a major role in its symptoms.     restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity     and therefore lower androgen production in women with pcos women.the purpose of this study is     to determine which diet is more effective in improving metabolic and reproductive outcomes.   "
127528|NCT01615835|"     Use of the EnSite NavX system to map the coronary vasculature during CRT implant   "
127529|NCT01615822|"     OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the     advantage of a longer elimination half-life so is being developed to be administered together     with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated     malaria. The study findings will be used to inform the dose and design of future studies. The     aim of the study is to establish the safety, tolerability and pharmacokinetics of     co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy     volunteers.   "
127530|NCT01615809|"     The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised     amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary     aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive     chemotherapy.   "
127531|NCT01615796|"     GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of     antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive     pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative     pathogens associated with respiratory tract, skin and soft tissue infections including     isolates resistant to existing classes of antimicrobials.   "
127532|NCT01615783|"     Reports suggest that the Medicaid population includes a higher percentage of smokers than the     general population. A high prevalence of smokers in a population is likely to lead to a     higher burden of chronic obstructive pulmonary disease (COPD). Few studies have evaluated the     economic burden of COPD in a Medicaid population. The objective of this observational,     retrospective cohort study is to estimate the economic burden of COPD in subjects with a COPD     diagnosis who are enrolled in Medicaid and are receiving maintenance treatment covered by     Medicaid.      Specifically, the null hypothesis for the primary outcome measure is that no difference is     observed in all-cause costs between subjects with and without COPD. The test hypothesis is     that there is a difference in all-cause costs between subjects with and without COPD.      Secondary outcomes to be evaluated include all-cause resource use and COPD-related costs for     the COPD cohort.      The study uses a medical and pharmacy administrative claims database called MarketScan     Medicaid Database that contains the medical, surgical, and prescription drug experience of     nearly 7 million Medicaid recipients. This analysis will use data from 8 states.   "
127533|NCT01615770|"     Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment     strategy in promoting longer-term smoking abstinence. The investigators will also conduct     secondary analyses of mediators and moderators of treatment response.   "
127645|NCT01614288|"     Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a     knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life     questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.   "
127535|NCT01615744|"     Between 1994-98 5 hospitals in Stockholm investigated calcaneal fractures in a randomised     study.      82 patients were included and randomized either to non-surgical treatment or surgical     management with extensile lateral approach and reduction with Internal fixation (ORIF) The     patients were followed and investigated at fixed intervals 2 weeks, 8 weeks, 3 months and 6     months for clinical review. At 1 year and 8-12 years (mean 10 years) post-injury.      Both clinical radiological data were collected and several scores were used. The primary     outcomes scores used were SF-36 and VAS score.      The results after 1 year and mean 10 years are presented.   "
127536|NCT01615731|"     A common practice for preparation for surgical abortion after 19 weeks gestation is the     placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The     investigators aim to study the addition of mifepristone as an adjunct to cervical dilation     prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of     painful procedures and time in clinic (or away from work/home) that multiple sets of dilators     can require. The investigators hypothesize that one set of dilators with mifepristone will     result in similar procedure times and decreased total time as two sets of dilators.   "
127537|NCT01615718|"     In this study, the investigators aim to investigate the effects of non-invasive     neurostimulation - low-intensity transcranial electrical stimulation in conjunction with     transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. The     investigators want to see if there is a difference between active and sham stimulation on     these motor symptoms.   "
127538|NCT01615705|"     The purpose of this study is to evaluate whether biomarkers of inflammation, genetic     thrombophilia and coagulation activation influence Post-Thrombotic Syndrome development in     patients with symptomatic proximal deep venous thrombosis.   "
127539|NCT01615692|"     The purpose of this study is to evaluate leg health for one additional year in patients with     symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic     Syndrome (PTS) during the 2 years of follow up in the SOX Trial.   "
127540|NCT01615679|"     Non-interventional study to gain further information about the therapy progression in routine     treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be     on the improvement of the clinical global impression (CGI) in comparison to the outcome of     randomized, controlled studies.   "
127541|NCT01615666|"     The purpose of this study is to use a functional MRI (fMRI) index to compare the brain     activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and     Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's     disease.      The study hypotheses are:        1. The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia,          and healthy volunteers;        2. The fMRI index will distinguish participants with MCI who convert to Alzheimer's disease          from those who convert to a non-Alzheimer's dementia and those who remain stable;        3. MCI participants with a lower fMRI index at baseline who convert will progress to          Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a          faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's          disease.   "
127542|NCT01615653|"     -  Hypothesis:           - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the          efficacy of neurolysis and subsequent pain control and survival in patients with          pancreatic carcinoma.        -  Rationale:             -  Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal               thereby only briefly remaining in contact with neural structures and limiting the               degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result               in diminished neurolysis and decrease efficacy.   "
127543|NCT01615640|"     The aim of the study is to assess the accuracy of dynamic contrast enhanced and     diffusion-weighted MR Imaging in evaluating response to chemotherapy in osteosarcoma.   "
127544|NCT01615627|"     The investigators will test whether hypotonic (diluted) remodulin solution causes less pain     than the eutonic (undiluted) solution supplied by the manufacturer.   "
127545|NCT01615614|"     The purpose of this study is to explore the pharmacokinetics of different dosing regimens of     rilpivirine in combination with rifabutin in healthy participants.   "
127546|NCT01615601|"     The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine     (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are     naïve to these medications and in patients who have experienced tolerability issues on their     current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by     switching the patients from their previous or current combination antiretroviral therapy     (cART) to either darunavir or etravirine.   "
127547|NCT01615588|"     Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different     geographical locales around the North Island of New Zealand and tested for glycaemic index     (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed     honey containing 25g of available carbohydrate in 200 ml water and the blood glucose     responses measured (area under the curve; AUC) and compared to that of 25 g of available     carbohydrate from glucose.   "
127548|NCT01615575|"     The aim of the present study was to compare the results of transanal haemorrhoidal     dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV     haemorrhoids with a long-term follow-up.   "
127549|NCT01615562|"     The purpose of this study is to determine if changes in blood vessel health lead to the     menstrual irregularities that women with PCOS experience. This research study will help     determine if women with PCOS have early changes in their blood vessels called endothelial     dysfunction, and if the number of progenitor cells (cells that in a healthy person repair     blood vessel damage) are related to these blood vessel changes. To do so, we will compare     ultrasound (soundwave) pictures of a large blood vessel in the arm and the results of blood     tests between women with PCOS and other healthy women with normal menstrual periods.   "
127550|NCT01615549|"     Virtual reality devices are widely accepted tools to familiarize surgical novices with the     principles of laparoscopy. Free Virtual reality training will be tested against basic     training and efficacy assessed in a randomized controlled trial of surgical novices.   "
127551|NCT01615536|"     The hypothesis of this study is that canine fossa trephination (CFT) improves surgical     outcomes for patients with a severely diseased maxillary sinus.   "
127552|NCT01615523|"     Hd-EEG and MRI measures are used to study the maturation of functional networks in order to     identify the neural circuits underlying executive and memory processes in children born     preterm. It will be determined whether children born preterm with executive function deficits     will have an abnormal connectivity between basal ganglia and cortex due to WM injury.     Moreover, the development of hd-EEG activity during sleep (coherence and travelling waves)     and brain maturation of children and adolescents born preterm will be compared with the     respective measures in healthy controls. This is of eminent importance as it helps to     understand the nature of executive function and hence, it may help to develop neuroprotective     strategies to prevent executive function deficits in these infants.   "
127553|NCT01615510|"     MOR-NRI like Tapentadol are expected to reduce signs and symptoms of central sensitisation     besides effectively reducing pain intensity in pain. Human pain surrogate models can serve in     this proof-of-concept study to further elucidate this assumption.   "
129461|NCT01590576|"     The purpose of this study is to investigate the comorbidities of lower urinary tract symptoms     or pelvic organ prolapse in a nationwide population-based data in Taiwan during the study     period of 2001-2010, a total of 10 years.   "
127554|NCT01615497|"     The investigators are conducting a randomized clinical trial of our new web-based version of     the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically     designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling     at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT)     focuses on teaching basic coping skills, presenting examples of effective use of coping     skills in a number of realistic situations in video form, and providing opportunities for     patients to practice and review new skills while receiving substance abuse treatment.   "
127555|NCT01615484|"     The purpose of this research study is to learn about the safety of transplanting lungs     obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a     breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion     solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done     outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device     used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and     ventilation is to learn how well the lungs work, and whether they are likely safe to     transplant.   "
127556|NCT01615471|"     The Lose Now NC research study aims to determine feasibility by delivering a community based     weight loss program for 4 months in Kannapolis, NC in a large group format compared with     smaller group format, (recruiting approximately 225 participants from Mecklenburg and     Cabarrus counties and randomizing them to large or small group in-person sessions coupled     with an interim internet program) to examine reach and recruitment potential, pilot     intervention procedures, collect process measures to determine satisfaction, adherence,     attrition, and estimate weight loss for planning a larger trial.   "
127557|NCT01615458|"     This study will determine if a version of the chronic care model for individuals with mood     disorders can improve patient health.   "
127558|NCT01615445|"     Previous animal studies have found that resveratrol supplementation significantly increased     aerobic capacity. The investigators conducted a randomized placebo-controlled cross-over     study to assess whether resveratrol could provide similar benefits in humans.      All participants were assigned to two 4-week treatment periods, with a 2 week washout     in-between. During one period, volunteers in received resveratrol and during the other     period, they received identical-appearing placebo.      The primary outcome of interest was change in exercise capacity, as measured by change in     exercise duration on constant load exercise testing and change in aerobic capacity (peak VO2)     on incremental exercise testing. Secondary outcomes were tolerability and side-effects     associated with resveratrol.   "
127559|NCT01615432|"     Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2     ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients     admitted in the intensive care unit for respiratory failure and treated with NIV.   "
127560|NCT01615419|"     This multi-center, observational study will evaluate the use in clinical practice and     efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible     patients initiated on RoActemra/Actemra treatment according to the approved label will be     followed for 6 months.   "
127561|NCT01615406|"     This is a single arm, open label study of up to 24 prostate cancer patients scheduled for     prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of     99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard     of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND)     within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for     visible uptake and compared with histopathology.   "
127562|NCT01615393|"     This prospective, randomized, single-blind, cross-over study will compare the bioavailability     of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in     healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of     ribavirin either as a capsule or as tablets; after a washout phase volunteers will be     crossed-over to the other treatment. The anticipated time on study treatment is 10 days.   "
127563|NCT01615380|"     Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer     and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be     an efficacious treatment component in combating nicotine dependence, especially among women     for whom concerns about weight gain during smoking cessation are an obstacle to successful     quitting. In previous trials of women smokers, the investigators program of cognitive     behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more     efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to     Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental     Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the     Commit to Quit program is well poised for a larger trial in a community setting where it has     the potential to reach a large number of female smokers in a setting in which it can be     sustained. In response to PA-03-126, Behavioral Therapies Development Program, the     investigators propose a Stage III study in which they will conduct a trial to test the     investigators CTQ smoking cessation program in the community setting of the local YMCAs. As     stated in the PA, Stage III research is aimed at understanding if and how an efficacious     therapy may be transported to the community. The investigators propose a randomized     controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The     trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT     smoking cessation treatment plus contact control. In order to promote transportability to the     YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is     similar to the investigators CTQ exercise program, in that it is guided by trained staff and     requires participants to exercise 3 times per week. If the exercise condition is found to be     more efficacious than contact control when delivered at the YMCA by YMCA staff, then the     investigators will be well positioned to partner with the YMCA to pursue widespread, national     dissemination of this program.   "
127564|NCT01615367|"     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in bipolar     disorder, yet no empirically validated psychosocial interventions to manage risk factors for     CVD in BD have been developed. The purpose of this study is to develop and test the     feasibility of an integrated treatment to decrease CVD risk factors, while exploring whether     the intervention improves overall functioning and mood symptoms. The designed treatment     integrates theories on Nutrition strategies, Exercise interventions, and Wellness Treatment     (NEW Tx) to address risk factors for CVD that co-occur with bipolar disorder. NEW Tx includes     novel intervention strategies in each of these three modules, as well as modified and     tailored empirically-supported strategies for bipolar disorder. The primary hypotheses are     that NEW Tx will be feasible to deliver, acceptable to this population, and associated with     improvements in CVD risk factors (i.e., waist circumference). Exploratory analyses will     examine predictors of treatment response and the effect of NEW Tx on mood symptoms and     overall functioning.   "
129589|NCT01588899|"     The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve     Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment     of uterine fibroids in a Chinese population.   "
127565|NCT01615354|"     This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of     aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy     volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the     other period volunteers will receive placebo.   "
127566|NCT01615341|"     Chronic allograft injury is the leading cause of graft loss in renal transplantation. The     shortage of available kidneys for transplantation has reached crisis levels with increasing     numbers of waiting list mortalities. Strategies to prolong graft survival are urgently     needed. The pediatric and young adult transplant population is one in which repeat     transplantation is inevitable and therefore, this group is one who will especially benefit     from intervention to prolong graft survival. The hypothesis of this proposal is that     subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic     allograft injury. The young age of the proposed study population is an ideal one to evaluate     this objective due to the high prevalence of seronegative recipients. The studies outlined     will determine the temporal relationship betWeween subclinical viremia, renal allograft     infection and allograft injury. This will be the first prospective study in renal transplant     recipients to systematically monitor subclinical viral infection both in peripheral blood and     in the renal allograft with concurrent quantitative measures of renal function, allograft     fibrosis, and innate immune activation. The investigators have chosen these 3 outcomes     because they evaluate a spectrum of renal allograft injury and represent different stages -     from early to late - in the pathophysiology that leads to renal allograft dysfunction. In     addition, the role of virus specific T cell immune responses in the control of subclinical     viral infection and associated allograft injury will be determined. These data are critical     as they will provide insights into the pathogenesis of injury and will guide development of     interventions strategies. Importantly, the current treatment strategies for viral disease do     not prevent subclinical viral infection. Thus, the results of this study may identify that     prevention, prophylaxis and/or treatment of subclinical viral replication as a long term     strategy to prevent chronic allograft injury and prolong graft survival.   "
127567|NCT01615328|"     Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety     of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic     radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using autogenous iliac     bone graft is gold standard, however, it may lead to donor-site morbidities. Preventing these     complications, some authors have tried to use alterative bone graft substitutes. Among these     alternatives, Cervios ChronOs™ which is the polyetheretherketone (PEEK) cage with     b-tricalcium phosphate (TCP) has become popular and shown good clinical results. However,     b-TCP has only osteoconduction ability of three osteogenic properties.      Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized bone     matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and     osteoinduction, therefore this alternative is expected to show superior bone fusion     capability to PEEK cage with b-TCP. However, there has been no comparison study between the     PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate     bone fusion rate between these cervical spine cages using postoperative computed tomography     (CT)   "
127568|NCT01615315|"     Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin     treatment and hematuria in general population is not well known. The investigators will     evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy     large screened populations.   "
127569|NCT01615302|"     Rationale:      Closure of the internal opening is the most accepted standard procedure in the treatment of     peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one out     of the three patients mucosal flap repair fails. Possible causal factors are incomplete     clearance of pus and debris, incomplete closure of the internal opening, inappropriate host     response in patients with risk factors like smoking or diabetes. Platelet derived growth     factors may facilitate closure of the internal opening, especially in patients with impaired     wound healing.      Objective:      The use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal     advancement flap to achieve a better closure rate of complex peri-anal fistula's.      Study design:      Randomized, multicenter trial.      Study population:      Patients with complex cryptoglandular peri-anal fistula's.      Intervention:      Injection of PRP in the curretted fistula track under the mucosal flap.      Main study parameters/endpoints:        -  Recurrence rate        -  Post-operative pain        -  Continence        -  Quality of life.      Nature and extent of the burden and risks associated with participation, group relatedness:      Because autologous blood is used, no extra risk are expected.   "
127570|NCT01615289|"     Green tea is being recognized as a beverage with potential benefits for human health and on     cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea     intake may play a positive role in improving effects on cognitive functions. The     investigators aim to examine the neural effects of green tea extract on brain activation in     humans.   "
127571|NCT01615276|"     In the present study, the effect of a bolus of intrinsically labeled milk directly after     one-legged NMES will be studied.   "
127667|NCT01614002|"     The main purpose of this observational study with Docetaxel is to determine the number of     treatment cycles and the quantity of Doce onkovis needed therefore under the special     circumstance of ambulant chemotherapy.      onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted     packaging sizes as to decrease the excess quantity to be discarded follows also this     objective.      Secondary objectives are the evaluation of the safety and tolerability of Doce onkovis. To     this purpose data regarding co medications and adverse events are also collected.   "
129708|NCT01587326|"     The association of cytokines with escitalopram has not been investigated in patients with     major depressive disorder (MDD). Hence, the investigators will examine this association.   "
127572|NCT01615263|"     Lung isolation is frequently used during thoracic surgery. Two techniques are principally     used: the double lumen tube (DLT) and the bronchial blocker (BB). BB is easy to use but its     reputation is darken by the need of multiple repositioning during surgery and especially by a     slower lung collapse than the DLT. Reading recent literature on the subject and according to     the vast experience of numerous hospital centers, it seems that the slowness of lung collapse     remains without any solution. This slowness in lung deflation is detrimental to the     initiation of video-assisted thoracoscopy surgery (VATS) and could be exacerbated in chronic     obstructive disease (COPD) patients. For this reason, BB use is discredited in numerous     centers. However, at IUCPQ, the investigators rarely observe slow lung collapse when BB are     used. For many years, the investigators have used a systematic denitrogenation of the lung     before the initiation of one lung ventilation (OLV). Furthermore, when the patient is     positioned in lateral decubitus, the investigators impose an apnea period of about 30 seconds     to favor collapse of the isolated lung before inflating the cuff. This apnea is always     limited by the occurrence of oxygen desaturation (≤97%). The investigators also proceed to a     second period of apnea of 30 seconds associated to a deflated BB's cuff at the pleural     opening. Subsequently, the investigators inflate the BB's cuff to obtain definitive lung     isolation. The investigators hypothesis is that the use of two apnea periods, when isolating     the lung with a BB, will allow the same quality of surgical exposure at 0, 5, 10 and 20     minutes post opening of the pleura, compared to the one obtained with a DLT. The main     objective of this study is first to compare the delay between the initiation of OLV and     complete lung collapse obtained with BB and DLT, in two groups of patients undergoing VATS.     Secondary objectives are: 1) to evaluate the quality of surgical exposure associated to the     level of lung collapse, 2) to evaluate the quality of surgical exposure through the video     camera, 3) to collect surgeons' opinion regarding the device (BB or DLT) that they thought     was used during surgery. After obtaining institutional review board (IRB) approval, the     investigators propose a study of 40 patients undergoing an elective VATS at the Institut     universitaire de cardiologie et pneumologie de Québec (IUCPQ) involving an one lung     ventilation. They will have to be 18 years old or more, to read, understand and sign an     informed consent at their pre-operative evaluation. This study will be prospective,     randomized, and blind to thoracic surgeons.   "
127573|NCT01615250|"     This is a randomized study of efficiency and safety of intramyocardial implantation of     peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with     myocardial ischemia after preparatory course of shock - wave therapy.   "
128537|NCT01602627|"     This phase I trial studies the side effects and best dose of Hsp90 inhibitor AUY922 in     treating older patients with advanced solid malignancies. Hsp90 inhibitor AUY922 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth   "
127574|NCT01615237|"     System level strategies for implementing tobacco use treatment guidelines exist but are     insufficiently put into practice, particularly in dental care settings. Closing the gap     between research and practice is stymied by the limited research on systems changes necessary     to implement tobacco treatment in routine dental care. Drawing from a burgeoning     dissemination science literature, the proposed study compares the cumulative benefit of the     following three systems-level strategies: 1) staff training and clinical reminders, 2)     provider feedback and 3) pay-for- performance (financial incentives), that have been widely     endorsed by a 2001 Institute of Medicine Report, Crossing the Quality Chasm (IOM 2011) and     the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).      The investigators propose a 3-arm cluster randomized controlled trial that will analyze the     implementation process and compare the cost and effectiveness of three implementation     strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider     performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for     tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory     of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) the     investigators will identify multi-level factors that facilitate or impede the implementation     process in dental clinics. Our primary outcome is improvement in provider delivery of tobacco     cessation treatment found through extensive meta-analysis (Fiore 2008) to be an essential     determinant of patient cessation outcomes. Our secondary outcome will be post-intervention     patient-reported quit rates. In addition to examining the comparative effectiveness of the     three implementation strategies, the investigators will use a mixed methods approach to     examine implementation processes (Aim 2) to assess the degree to which the interventions are     integrated into practice as intended and to clarify the mechanisms through which the     intervention influences provider behavior.   "
127575|NCT01615224|"     Missed abortion is a condition where the fetus has perished but the miscarriage is not     expelled. Women often present at a routine ultrasound or with a slight brownish discharge.     Traditionally this condition has been treated with curettage or vacuum aspiration. Lately,     medical treatment has become more common due to less risk of infection and other     complications. The routine medical treatment is 800mcg of misoprostol administered vaginally.     We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal     misoprostol increases efficacy of the treatment.   "
127576|NCT01615211|"     In menstruation an effective shedding of the endometrial lining occurs. Both progesterone and     estrogen levels fall sharply at this time. During medical abortion the endometrial shedding     is sometimes ineffective causing an incomplete abortion which may cause prolonged bleeding or     require surgical intervention. In medical abortion a progesterone antagonist is used as     treatment but the estrogen levels are not targeted. The investigators wish to explore whether     addition of letrozole or trilostane which target estrogen levels can lead to a more effective     shedding of the endometrial lining.   "
127577|NCT01615198|"     The purpose of this study is to access the efficacy and safety of LCZ696 compared to     olmesartan in elderly Asian patients for the treatment of hypertension.   "
127578|NCT01615185|"     Background: Surveys have shown that antipsychotic drug combinations are frequently     prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of extrapyramidal     symptom (EPS) but with high cost compared to sulpiride. The objective of the study is to     compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus     800-mg sulpiride in the treatment of acute psychotic exacerbations of schizophrenia.      Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are     randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800     mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety,     but different cost.   "
127579|NCT01615172|"     Comparision of two different cannulation techniques on the neurological outcome in cardiac     surcical procedures. Study hypothesis: Cannulation of the axilaris artery can reduce     neurolocical side effects.   "
127580|NCT01615159|"     The overall objective of this study is to assist the general public in achieving and     maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium     intervention that emphasizes spices and herbs. The investigators hypothesize that after four     weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium     intake of 1500 mg/day and their taste preferences will change. The investigators also     hypothesize that individuals in a low sodium behavioral intervention will maintain greater     adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed     control group.   "
127668|NCT01613989|"     Computer assistance in prosthetic hip surgery is able to improve the accuracy of the surgery:     Associating hip navigation and EOSTM imaging pre-operatively could simplify the procedure of     hip navigation in lateral decubitus while maintaining the accuracy of the technique   "
129430|NCT01590979|"     The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset     atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient     population at Staten Island University hospital.   "
127581|NCT01615146|"     As a result of the underlying disease or its therapy, it is common for patients with blood     cancers to have low platelet counts. While platelet transfusions may be beneficial in     preventing or treating bleeding symptoms, in circumstances where the risk of bleeding is low     they may be unnecessary or even harmful. As a blood product, transfusion of platelets may be     associated with infectious or allergic complications, and frequent hospital visits for     transfusion may adversely affect quality of life. Additionally, the potentially overuse of     platelet products places a burden on health care resources.      The benefit of the current practice of prophylactic platelet transfusions to prevent     hemorrhage is unknown. The randomized data that exists is more than 25 years old and not     informative given methodological limitations and the changing standards of supportive care.     An alternative, therapeutic, strategy involves only administering platelets to control active     bleeding.      The standard of practice in inpatients receiving high dose chemotherapy (either for acute     leukemia or as part of stem cell transplantation) is prophylactic platelet transfusions. In     outpatients not receiving high dose chemotherapy, the risk of bleeding is significantly     lower. No randomized trials have examined the optimal platelet transfusion strategy in     outpatients with blood cancers undergoing supportive or palliative therapy. Thus the     potential benefit of prophylactic transfusions in the outpatient setting is unknown.      The investigators propose to perform a pilot randomized controlled trial to determine if a     larger trial is possible. The ultimate goal is to determine if a strategy of therapeutic     platelet transfusions is safe and effective in outpatients with blood cancers and low     platelet counts.   "
127582|NCT01615120|"     Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum     prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic     Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with     luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy.     This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.   "
127583|NCT01615107|"     The paucity of published data concerning the issue of mechanical labor induction in the     setting of Term PROM has led us to undertake the present clinical trial. This study is     designed to compare the efficacy and safety of the standard Oxytocin induction protocol with     the double-balloon catheter device with concurrent oxytocin administration in patients with     Term PROM and unfavorable cervical conditions.   "
127584|NCT01615094|"     The study is designed to find out more about how mood and the nervous system affect the     body's immune system. The investigators plan to study this in people who have been identified     by their physician as being at-risk for the development of heart failure. There will be     approximately 525 individuals participating in this study at UCSD and at the VASDHS.     Individuals who will be asked to take part in this study will have a functional or structural     heart problem apparent on an echocardiogram, or a previous heart attack, but no symptoms of     heart failure. Some individuals will only complete one assessment (consisting of     psychological questionnaires and interview, walk test, blood draw, and body measurements),     whereas others deemed high-risk on the basis of a laboratory test, will be asked to     complete that same assessment every 6 months for the duration of the study.   "
127585|NCT01615081|"     Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with     other composition and amount of carbohydrates could be of interest in order to decrease the     glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a     sweet flavor but contains a different composition and amount of carbohydrates together with a     small amount of protein compared to sucrose. Malt extract may therefore be a better     alternative than sucrose as a sweetener due to a lower increase and more sustained blood     glucose level. This could be of interest in relation to diabetes and appetite regulation but     this is yet to be investigated.      Thus the objective is to investigate the effect of malt extract vs. sucrose on:        1. 3-hour change in the concentration of glucose and insulin        2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)        3. Ad libitum energy intake      Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The     test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and     sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be     assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch   "
127586|NCT01615068|"     This multi-center, prospective observational study will evaluate the treatment patterns, and     the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible     patients will have an initial metastatic breast cancer diagnosis that has not been previously     treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis.     Data will be collected for up to 8 years.   "
127587|NCT01615055|"     Many cancer survivors are experiencing problems with memory and other cognitive abilities     following cancer treatment. Little is known concerning the contributions of potentially     preventive therapies on cognitive function, but animal studies have pointed to the potential     value of the medication fluoxetine in this context. We aim to determine whether six months of     fluoxetine therapy can preserve brain function in patients who have undergone chemotherapy,     and examine potential biological mechanisms for its protective effects in humans. If use of     fluoxetine in cancer patients can be validated in this manner, it will represent the first     drug demonstrated to prevent cerebral dysfunction associated with exposure to chemotherapy.     Moreover, as this involves an agent that is already FDA-cleared for other indications, widely     commercially available throughout the U.S. and other parts of the world, and relatively     inexpensive since it is obtainable in generic formulations, it would represent a     pharmacologic approach that is amenable to rapid translation to the clinical setting.   "
127588|NCT01615042|"     Lenalidomide is a drug that alters the immune system and it may also be directly toxic to     tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly     kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast     cells in preparation for a bone transplant.   "
127589|NCT01615029|"     The purpose of this study is to establish the safety profile of daratumumab when given in     combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and     refractory Multiple Myeloma (MM).   "
129937|NCT01584284|"     The purpose of this study is to determine the safety and tolerability of GL-ONC1 administered     intravenously in combination with radiation therapy and cisplatin (CDDP)in patients with     locoregionally advanced head and neck cancer.   "
127590|NCT01615016|"     The lungs of infants born too early are extremely underdeveloped. Respiratory Distress     Syndrome (RDS) is a condition that frequently develops in infants born more than 10 weeks     early and leads to the collapse of their lungs. Because the lungs had not had enough time to     mature, they lack a substance, called surfactant that prevents their collapse. To treat this     problem, physicians apply surfactant to the lungs within the first few hours of life by way     of the infant's airway using mechanical stimulation (ventilation). Although this treatment     has significantly decreased the number of infants who die from RDS, the mechanical     ventilation can cause damage to the tiny lungs that may lead to long term lung disease and     breathing problems.      The need for more gentle and less invasive methods of deliver the surfactant to the infant     has led to the development of two new methods that require little or no mechanical     ventilation. While both methods are known to work there is no study that has assessed whether     one method is better than the other or causes fewer complications for the infant. The     proposed study will determine if it is practical to conduct a clinical trial to compare both     methods of surfactant administration and to gather preliminary data on which method gives     better results. Should this study look promising, the resulting data will be used to design a     larger clinical trial to compare the methods of mechanical ventilation. Results of such a     trial would help us to understand the best way to administer surfactant to preterm infants     and thus help doctors to better care for tiny infants at risk of lung disease.   "
127591|NCT01615003|"     In this study, typical cases of blood stasis syndrome of coronary heart disease are selected,     by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and     verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by     Xuesaitong soft capsules to investigate related miRNA and its target gene of Coronary Heart     disease.   "
127592|NCT01614990|"     The purpose of this study is to evaluate the safety and efficacy of repeated oral     administration of macimorelin at different doses daily for 1 week for the treatment of cancer     cachexia.   "
127593|NCT01614977|"     Nontuberculous mycobacteriae (NTM) are a group of bacteria that typically cause infections of     lymph nodes in the neck and face of otherwise healthy children.      There are currently 3 strategies to manage these infections. Yet, all are not ideal and     each has downsides.        1. Surgery: removal of the affected lymph nodes is the most common approach but has the          disadvantages of potential facial nerve paralysis, the possibility of recurrent          infection that would require another operation and resolution with a cosmetically          disturbing scar.        2. Antibiotics: The antibiotic courses are prolonged and are associated frequently with          adverse reactions. It is unclear if this treatment has a significant effect on the          natural resolution process of the infection.        3. Observation: follow-up the healing process without intervention. However the resolution          may last a long period of time even more than a year. In almost all cases there will be          spontaneous discharge of pus from the involved lymph nodes onto the skin that may last a          few days. Later on a scar will form that may also be disturbing cosmetically.      The inflammatory response of the body to infections may occasionally be severe. As a matter     of fact its harmful consequences can be sometimes more serious than those of the bacteria     that cause the infection. Prednisone and other anti inflammatory drugs have properties that     could possibly prevent this.      There is medical experience in using prednisone and similar drugs in addition to antibiotics     in infectious diseases to decrease the inflammatory response against the infection. One of     these infections is tuberculosis. The tuberculous bacteria have some common features with the     nontuberculous mycobacteria. The investigators believe that the inflammatory process in     infected lymph nodes with nontuberculous mycobacteria is the major cause for the discharge     from the skin which later leads to the formation of a scar and to the prolonged resolution     from the infection. Thus in order to hasten the resolution and to avoid formation of a neck     or facial scar with its cosmetic consequences we suggest the use of prednisone in treating     nontuberculus mycobacteria lymph nodes infections. Since prednisone depresses the     inflammatory process as well as the immunity response, we chose to study the effect of     prednisone combined with antibiotics (as the later will help to overcome the bacteria).      The purpose of the study is to determine whether the addition of prednisone to antibiotic     treatment of nontuberculous mycobacteria lymph nodes infections in the neck and face of     children can hasten the resolution process and improve its cosmetic results.      The diagnosis of nontuberculous mycobacteria lymph node infection will be based on evidence     of bacterial growth in culture or on the presence of DNA of the bacteria in pus obtained from     the involved lymph nodes by fine needle aspiration.      Generally healthy children with evidence of infection will be offered to participate in the     study. They will be randomly assigned into the following 2 groups for 8 weeks treatment:        1. Antibiotics (2 types) and prednisone.        2. Antibiotics (2 types) and placebo (a material that tastes and look like prednisone but          does not have any medical effect).      Prednisone will be given in a dose that will decrease into half twice: after 2 and after four     weeks.      Follow-up visits for monitoring the inflammatory process and its resolution as well as     adverse reactions will be done around 2 weeks, 4 weeks 3 months and 6-8 months after     beginning therapy,      Blood tests and chest X-rays will be taken prior to the beginning of treatment. Blood tests     will be also taken at the first follow-up visit.      A photo of the face neck and the site of the involved lymph nodes will be taken before     starting therapy and at each of the follow-up visit.   "
127618|NCT01614639|"     We are doing this research study to learn about how acupuncture treatment works. This study     is being done to look at changes in the brain, NOT to treat pain. We want to learn about     brain activity during acupuncture. We will look at brain activity when a heating device     touches the skin of a subject before and after the subject has acupuncture, to see what     changes.   "
129602|NCT01588730|"     The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to     static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).   "
127594|NCT01614964|"     This is an initial efficacy study of a candidate antimalarial in human subjects with     uncomplicated malaria caused by the most common and most important parasite in Africa     (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P.     falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug     (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem     twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly     effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both     chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of     Orphan Product Development (OOPD).   "
127595|NCT01614951|"     The purpose of this study is to investigate whether patients with a preoperative reduced     pulmonary function have a better preserved oxygenation capacity after open heart surgery,     using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with     standard ECC (Extra Corporal Circulation).   "
127596|NCT01614938|"     The purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin     neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly     cisplatin in locally advanced nasopharyngeal carcinoma.   "
127597|NCT01614912|"     The study evaluates the long term safety and efficacy of SM-13496 in patients with     schizophrenia.   "
127598|NCT01614899|"     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients     with schizophrenia.   "
127599|NCT01614886|"     To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration     of Rivastigmine patch in the Japanese population.   "
127600|NCT01614873|"     Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical     ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory     Assist)   "
127601|NCT01614860|"     Post-discharge mortality and re-hospitalization for acute heart failure (AHF) affects 15% and     30% of patients respectively, within 90 days. With over 1 million annual hospitalizations and     a financial cost exceeding 20 billion dollars, AHF is a major public health burden. Yet no     AHF therapy to date definitively reduces morbidity and mortality, and in stark contrast to     heart attack patients, highly rated evidence in guidelines do not exist. Although AHF is a     syndrome and not one disease, typical treatment of patients hospitalized with AHF suggests     otherwise. Despite substantial differences among AHF patients, therapy is largely uniform;     patients receive medicine to help get rid of excess volume and little else. Although decades     of empirical use support the symptomatic benefits of traditional therapies, outcomes remain     extremely poor. As opposed to the one-size-fits-all‟ approach used unsuccessfully to date in     clinical trials, identification of specific AHF patient sub-groups is critical, so that     tailored therapies can be developed and tested. Preliminary data suggests that the     neurohormone aldosterone may be detrimental in AHF patients. Furthermore, this hormone level     appears to rise during hospitalization. The investigators therefore propose to identify     specific AHF patient phenotypes associated with high serum aldosterone levels to subsequently     address the hypothesis that early aldosterone blockade continued throughout hospitalization     will decrease re-hospitalization and mortality. Specifically, the investigators hypothesize     that AHF patients with elevated serum aldosterone levels have a distinct phenotype compared     to those with lower or normal aldosterone levels. Specifically, they will be older, have a     lower systolic blood pressure, lower EF, worse renal function, higher BNP, and previous     hospitalization for HF.   "
127669|NCT01613976|"     The purpose of this study is to confirm the safety and tolerability of oral panobinostat     (PAN) in combination with a fixed dose of 5-Azacitidine (5-Aza) in adult Japanese patients     with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid     Leukemia (AML).   "
127602|NCT01614847|"     Background:      Osmolarity is defined as the concentration of particles dissolved in a solution. Normal tears     contain various dissolved particles including proteins, salts and other electrolytes. The     investigators plan to investigate how osmolarity of the tear film changes over time after     instillation of artificial tears containing hyaluronate. This is one kind of artificial tear     that is used to treat dry eye.      Dry eye and tear osmolarity:      Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and     ineffective. There has been a resurgence of interest and research in dry eye in the past 5     years, and tear osmolarity has emerged as perhaps, one of the most effective ways to evaluate     tear quality and dry eye status. Dry eye is usually treated with artificial tears, and many     formulations are available. The investigators will test an isotonic solution that contains     hyaluronate. Hyaluronate binds water and should help to maintain water on the eye.      Objective:      We plan to study the time course of possible changes in tear film osmolarity following     instillation of an isotonic artificial tear containing hyaluronate. The investigators will     use the TearLab, a new clinical instrument that has been developed to quickly and easily     measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity     over time can help doctors determine efficacy and dosing schedules. The investigators will     test the isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline     solution.      Hypothesis:      The investigators should be able to measure a decrease in tear osmolarity over time following     instillation due to the water-binding effect of hyaluronate artificial tears relative to a     control (normal saline solution).   "
127603|NCT01614834|"     The aim of this study is to validate a previously developed patient reported outcome     instrument (in project UCT-D) to assess disease control in chronic urticaria patients     (Urticaria Control Test - UCT) of age 12 and older.   "
127619|NCT01614626|"     The purpose of this study is to assess the longitudinal association between alcohol     consumption and biomarkers of microbial translocation (sCD14) and inflammation/altered     coagulation (IL-6/D-dimer); to establish a cohort of HIV-infected Russian drinkers; and to     establish a sample repository.   "
127620|NCT01614613|"     The purpose of this study was to test the performance of an investigational Bayer Blood     Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was     to obtain glucose samples from subjects with diabetes across the meter operating ranges. A     capillary sample was collected from each subject at 3 different times during the visit to     obtain natural capillary blood samples with a range of glucose concentrations. Some blood     samples were glycolyzed to lower the glucose concentration levels and glucose solution was     added to other samples to raise glucose concentration levels. All meter BG results were     compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose     Analyzer). All lancings and testing were performed by study staff.   "
127604|NCT01614821|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in     treating a specific cancer. Investigational means that PCI-32765 is still being studied and     that research doctors are trying to find out more about it-such as the safest dose to use,     the side effects it may cause, and if PCI-32765 is effective for treating different types of     cancer. It also means that the FDA has not yet approved PCI-32765 for use in patients,     including people with Waldenstrom's Macroglobulinemia.      PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent.     PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell receptor     (BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk protein,     which then results in malignant cell death. This drug has been used in laboratory experiments     and other research studies in B-cell malignancies and information from those other research     studies suggests that PCI-32765 may be a treatment strategy for B-cell malignancies,     including Waldenstrom's Macroglobulinemia.      In this research study, the investigators are testing the safety and efficacy of PCI-32765 as     a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.   "
127605|NCT01614808|"     This research study is looking at biomarkers in urine samples from patients with Wilms tumor.     Studying samples of urine from patients with cancer in the laboratory may help doctors     identify and learn more about biomarkers related to cancer. It may also help doctors predict     how patients will respond to treatment   "
127606|NCT01614795|"     This phase II trial studies how well cixutumumab and temsirolimus work in treating patients     with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them.     Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.   "
127607|NCT01614782|"     The purpose of this study is to assess the multiple rising dose safety/tolerability and     pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and     overweight/obese participants with Type 2 diabetes mellitus (T2DM).   "
127608|NCT01614769|"     This study aims to assess how glimepiride affects the recovery from hypoglycemia in     participants with type 2 diabetes mellitus. The primary objective is to estimate the time     taken by participants to recover from hypoglycemia to euglycemia after treatment with either     2 mg or 4 mg of glimepiride when compared to placebo.   "
127609|NCT01614756|"     The purpose of the study is to determine safety and tolerability of IL-31 mAB   "
127610|NCT01614743|"     This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy     and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients     with rosacea.      The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the     cheek area. Upon study entry, subjects will be randomized to receive treatment with     incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be     prepared by an unblinded designee and both Physician Investigator (PI) and subject will     remain blinded for the duration of the study. At the 16 week visit, control subjects will     enter the rescue arm portion of the study and all study subjects will receive treatment with     incobotulinumtoxinA to the cheek areas.   "
127611|NCT01614730|"     This user evaluation study is to verify that the Modified Neurotech Vital Device does not     stimulate the pelvic floor muscles compared with the Neurotech Vital Device.   "
127612|NCT01614717|"     This investigation is a prospective, randomized, single-blinded and multicenter design.      The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular     (BiV) pacing in severely symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients     with severe Left Ventricular Outflow Tract (LVOT) obstruction implanted with a Cardiac     Resynchronization Therapy - Pacing (CRT-P) device.      Randomization        -  Implant will be performed (CRT-P).        -  Patients will be randomized 1:1 to either Treatment Group (Optimized Biventricular (DDD)          pacing) or Control Group (Back-up Atrial (AAI) pacing) during the first 12 months:        -  Treatment Group. The patient´s device is programmed to optimized DDD BiV pacing        -  Control Group. The patient´s device is programmed to back-up pacing AAI.        -  After 12 months, the patients initially randomized to the Treatment Group (Optimized DDD          Pacing) will continue in the same group. The patients initially randomized to Control          Group (AAI Back-up Pacing) will be changed to the Treatment Group (Optimized DDD          Pacing). And all the patients will be followed 12 months more.   "
127613|NCT01614704|"     Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than     40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have     improved the prognostic of these patients. They will all most likely to received     chemotherapy. Despite the fact that chemotherapy has many side effects, these women do     question the impact of the treatment on their ability to procreate.      On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when     medical care potentially affect fertility.      Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols,     provide fertility information, and help individualize fertility preservation supports.      Principal objective is to ensure the absence of ovarian stimulation's side effects and assess     chemotherapy effects on child carrying potential.   "
127614|NCT01614691|"     This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients     with allergic rhinitis   "
127615|NCT01614678|"     The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses     manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured     using a semi-automatic process.   "
127616|NCT01614665|"     The purpose of this study is to compare how the body absorbs and processes two different     formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children     receiving an organ transplant, and how safe and effective they are over a longer period of     time.      This study is for children less than 16 years old. No minimum age has been set, however, to     be included in this study participants must able to swallow the medication capsules intact.   "
127617|NCT01614652|"     Treatment of ischemic heart failure.   "
127621|NCT01614600|"     The purpose of this study was to evaluate the reduction of contact lens-related dryness     symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES®     AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry     Eye Questionnaire (CLDEQ).   "
127622|NCT01614587|"     The objective is to explore the genetic predisposition to early pelvic organ prolapse after     adequate surgical repair by exploring the association between pelvic organ prolapse     recurrences and certain polymorphisms.   "
127623|NCT01614574|"     Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB)     that leads to progressive accumulation of glucocerebroside within macrophages and subsequent     tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. The disease     has been classified into 3 clinical subtypes based on the presence or absence of neurological     symptoms and severity of neurological disease. Type 1 Gaucher disease affects an estimated     30,000 persons worldwide and is the most common. Type 1 Gaucher disease does not involve the     central nervous system. Patients with type 2 Gaucher disease present with acute neurological     deterioration, which leads to early death. Those with type 3 disease typically display a more     sub-acute neurological course, with later onset and slower progression.      The primary objective of this study is to evaluate the safety of every other week dosing of     velaglucerase alfa in Japanese patients with Gaucher disease.      Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type     1 Gaucher disease.   "
127624|NCT01614561|"     This was a multicenter survey of patients who were on lipid -lowering pharmacological     treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the     effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan     and Lebanon.      Data collected from each patient took place at a single visit. Each participating doctor     filled the investigator questionnaire on his/her experience and perception of the management     of the hypercholesterolemia of his/her patients. Each doctor was asked to indicate his/her     general attitude on the diagnosis of hypercholesterolemia, the existing guidelines and goals     and the various treatment options for high cholesterol in blood.      Before being assessed by the investigator, patients recorded, on the patient questionnaire,     their awareness of high blood cholesterol , their current lipid-lowering treatment schedule,     their understanding of their condition and compliance in taking the medications on time.      The investigators completed a Patient Record Form (PRF) with the patient's basic information,     cardiovascular risk factors and the cardiovascular medical history, current lipid lowering     drug treatment and the reason for the current therapy.      A blood sample under fasting condition was drawn from each subject. A central laboratory in     Jordan received all samples. Every sample was analyzed for its cholesterol blood level,     fasting sugar level and hemoglobin A1C levels.   "
127625|NCT01614548|"     Some recent reports indicate that incidence of prostate cancer is increasing rapidly in     China. However, no large-scale survey of prostate cancer has been done in central China, few     data are available regarding its management. The investigators aimed to analyze the     management of prostate cancer and compare the outcome of patients with such a survey.      The investigators collected data of patients diagnosed with prostate cancer from the 2003 and     2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of     patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the     log-rank test and Cox proportional hazards model.   "
127670|NCT01613963|"     This is a study of visual outcomes in retinal disease that seeks to identify the causes of     visual loss. This data will be used to predict which patients are at risk of losing vision     and how they can be better treated.   "
127626|NCT01614535|"     The clinical studies demonstrate more powerful analgesic effect among female to both μ- and     κ-opioid agonist (Fillingim et al. 2004). The antitussive effect of opioid is mediated     predominantly by μ-, κ-opioid receptors (Kamei J. 1996). Therefore, the investigators     hypothesized that there are sex differences in the antitussive responses to opioid.      It has been reported that target-controlled infusion (TCI) of remifentanil can reduce cough     against endotracheal tube during emergence from general anesthesia. Some studies, reporting     the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in     different sex and surgeries (B. Lee et al. 2009, E.M.Choi et al. 2012), showed differences in     EC50 and EC95.      The purpose of this study was to find out EC50 and EC95 of remifentanil in effect-site TCI     for preventing cough during emergence in each sex and to evaluate whether there were sex     differences in EC50 and EC95 of remifentanil in effect-site TCI or not.   "
127627|NCT01614522|"     The purpose of this study is to determine whether ASLAN001 has an effect in patients with     recurrent or metastatic adenocarcinoma of the stomach, gastrooesophageal junction, or lower     third of the oesophagus whose tumours over-express HER-1 and HER-2, or whose tumours are     HER-2 gene-amplified.      Maximum of 26 patients will participate in South Korea and the patients will be assigned to     either group A or group B according to the results of tests done on tumor tissue obtained by     biopsy to determine HER-1 and HER-2 status.   "
127628|NCT01614509|"     This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined     therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the     treatment of macular edema associated with branch retinal vein occlusion.   "
127629|NCT01614496|"     The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system,     using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic     subjects. Ten subjects will be enrolled and they will participate in a cross-over study with     a control night, using their usual insulin pump pattern, and with a experimental night, being     controlled for the closed loop system. Each night includes the overnight control and prandial     control of the breakfast.      The system proposes an insulin dose every 5 minutes according with the value of glucose     displayed by the continuous glucose monitoring system.   "
127630|NCT01614483|"     The overall aim of the project is to provide proof-of-principle that biofortification of     cassava with vitamin A is a viable strategy to improve vitamin A status of deficient     populations.   "
127631|NCT01614470|"     The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects     with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR)     gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R,     G1244E, S1251N, S1255P, or G1349D).   "
127632|NCT01614457|"     The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects     with cystic fibrosis (CF) who have the R117H-CFTR mutation.   "
127633|NCT01614444|"     The current study will assess the efficacy of acupressure, a type of complementary and     alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild     traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented and     randomly assigned to either an active or placebo acupressure treatment series of 8 sessions.     The investigators will determine if acupressure affects aspects of day-to-day function, such     as memory, sleep, mood, psychiatric health and stress resilience. This information will help     identify potential treatment strategies to improve quality of life and overall function in     this particular Veteran population.   "
127634|NCT01614431|"     This study intends to verify the interference of N acetyl cysteine in the progression of     chronic kidney disease in patients with Nephropathic Cystinosis.   "
127635|NCT01614418|"     Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial     neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic     surveillance, there is no other intervention which predictably eradicates pre-cancerous     gastric lesions.      Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly     effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However,     the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study,     we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia     (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated     with endoscopic RFA. The safety and effects of RFA will be determined.   "
127636|NCT01614405|"     Patients with primary biliary cirrhosis (PBC) develop progressive liver disease and often     require liver transplantation. The cause of disease is unknown. It is thought to occur as a     result of an infection in subjects that are more susceptible to disease than others. The     investigators found evidence of retrovirus infection in patients with primary biliary     cirrhosis. The investigators found that most patients with PBC have evidence of viral     infection. Since then the investigators have conducted clinical studies using anti-viral     therapy. The investigators found that PBC patients treated with combination anti-retrovirus     therapy experienced significant reversal of the disease process. However, the changes were     not substantial and the investigators are now looking for better antiviral regimens. Now the     investigators have found a mouse model with a similar virus infection that develops a similar     biliary disease. Importantly, the investigators found that antiviral therapy blocks the     development of the disease in this mouse. The investigators have used this model to find     safer and more effective antiviral treatments for patients with PBC. The investigators have     now found out that a combination of highly active antiretroviral therapy with Truvada and     Kaletra stops disease in the mouse and plan to use this combination to see if it works in     patients with PBC.   "
127637|NCT01614392|"     This research study is looking to compare the effects of two uniquely different power     training interventions (high force, lower velocity versus low force, high velocity) on     changes in mobility status among older individuals at risk for mobility disability.   "
127671|NCT01613950|"     The study is intended to investigate the safety of BYL719 and AUY922 in patients with     advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination. In     addition, the preliminary efficacy of BYL719 in combination with AUY922, and the     pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study, if     their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2.      The study includes a dose escalation part followed by a safety expansion phase.   "
127638|NCT01614379|"     Diabetic foot ulcers often progresses after many years of diabetes where the patients system     is so damaged that normal heeling of ulcers cannot happen. The physician at the clinic     examines the foot, measuring its circulation and sensitivity. The measures are the blood     pressure in comparison between foot and upper arm and oxygen level in the foot. The     measurements have a direct connection to the blood circulation, but it doesn't visualize the     blood circulation.      Development of MR methods without the use of contrast agents have become so good that images     of the blood veins can be used in treatment. This means that the MR images provide important     information about the patient vessel wall stiffness and blood circulation without the use of     the damaging substances. Hence the physician can perform the MR examination and in comparison     with the test performed at the clinic he can make an improved and without risk diagnose.     Using MR at a lot earlier stage in the treatment is expected to reduce the number of     amputations. This is not only an economic advantage, but also an improvement of the patient     quality of life.      The objective of the study is to investigate type 1 diabetics oxygen level, vessel wall     stiffness, blood circulation, tissue contribution and blood pressure in the foot with the use     of conventional measurements in their treatment and with the added use of MR methods.      This will provide the physician with valuable information of the patient illness and is     expected to play an important role in the prevention of diabetic foot ulcers. We expect that     MR research leads to a much improved prevention and treatment of aggressive and destructive     diabetic foot ulcers. This will increase the general quality of life and reduce the large     number of amputations performed every year.   "
127639|NCT01614366|"     The purpose of this study is to compare the different dose of DMTA07 (DM) combine with     amlodipine in the treatment of mild to moderate essential hypertension, and to define the     optimized dose of DM in the combination therapy.   "
127640|NCT01614353|"     Patients can easily be overwhelmed, confused and many times don't fully understand their     need for new medications, or when the dosages are to be administered (patient research     partner quote). The long-term goal of this study is to refine medication science by     developing patient-centered assessment, monitoring and management guidelines for patients and     health professionals. The objective is to advance knowledge about the medication-taking     perspectives, experiences, and behaviors of older adults with multiple chronic medical     conditions (MCMC) to inform future research related to patient-centered medication     prescribing, monitoring and management. This pilot study addresses the following PCORI     interest area: evaluating methods that can be used to assess the patient perspective when     researching behaviors and choices within the patient's control that may influence outcomes.     The rationale that underlies the proposed study is that medication-taking practices are     wholly within patients' control, and are foundational to reducing complications and improving     outcomes for those with MCMC. To meet the overall objective of this application, the     following specific aims will be pursued: 1) identify perceptions and behaviors surrounding     the medication-taking process of older adults with MCMC; and 2) generate an interpretation of     the meaning of medication-taking among older adults with MCMC. To achieve these aims, data     will be obtained in real time from patients (N=30) receiving a new prescription using smart     phone technology. The smart phones will include prompts to help participants record thoughts     about medication use throughout the day for 30 days. Findings from electronic diaries will be     logged, analyzed and qualitatively analyzed. Some patients (n=15) will provide in-depth     hermeneutic interviews to provide rich descriptions and interpretive commentary about the     experience of receiving a new medication prescription. The objective is to uncover previously     unidentified areas of common experience in older persons with multiple chronic conditions who     have received a new prescription. Common experiences and patterns of influences, that are     often surprising or unexpected, will be categorized and assessed. The expected outcomes of     this pilot study are improved knowledge of medication-taking perceptions, experiences, and     practices of older adults with MCMC—knowledge that is critical to advance patient-centered     medication science.   "
127875|NCT01611285|"     Within the general objective of investigating optimal medical techniques for pelvic prolapse     repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more     cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision     analysis as the comparative strategy   "
127641|NCT01614340|"     The overall goal of this real-world comparative effectiveness research (CER) study is to     reduce disability among older home health patients by treating their pain more effectively.     To achieve this goal the investigators will conduct a cluster randomized controlled trial of     a physical therapist (PT) delivered intervention provided to VNSNY home health care patients     with activity-limiting pain. The intervention is an evidence-based non-pharmacological     program to reduce pain and pain-related disability that utilizes cognitive-behavioral pain     self-management (CBPSM) techniques.   "
127642|NCT01614327|"     The study is an Observational, Phase 0 designed to establish that the risk for diabetic     retinopathy assigned by the RiskAnalyzer improves the reading accuracy and consistency of any     reader and it decreases the inter-reader variability.      Objectives: Objectives one, two, and three are arranged chronologically and in an increasing     level of complexity as a three tiered approach to support the primary and secondary endpoint     of the trial. Objective one is to test fully each system components of the study limited to a     single site. Objective two is to evaluate the efficacy of the RiskAnalyzer to assign the risk     of Diabetic Retinopathy in comparison to the gold standard. Objective three is to demonstrate     that the reader's accuracy in grading images is improved when risk levels assigned by the     RiskAnalyzer are made available to the reader while performing the grading of the images     which is the primary endpoint of the trial Methods and Research Design: A network of clinical     study sites will be established to meet the required number of cases needed as calculated by     statistical analysis. Male and Female Subjects between the ages of 18-65 who are either     pre-diabetic or diabetics will be eligible for participation in this study. Subjects will be     recruited, consented, photographed and their images graded by two trained readers and     analyzed by the RiskAnalyzer . The risk levels that are obtained from the RiskAnalyzer will     be compared to the current gold standard practice, manual grading of each case by a reader.     Data collected during this clinical trial will be reported to the referring physician in the     form of a retinal screening report completed and signed by a licensed Ophthalmic professional     and delivered to their attending physician. Risk levels for diabetic retinopathy obtained by     use of the RiskAnalyzer will not be given to the attending physician under any circumstances     in order to preserve standard of care for the patient.      The sensitivity, specificity, receiver operating characteristic (ROC), and data flow process     of the RiskAnalyzer, retinal image reading system will be analyzed and based on the current     gold standard of a human reader. This study is a three-aims study, 24 month in length,     prospective, case-only study of the performance of the RiskAnalyzer. The risk levels obtained     from the RiskAnalyzer are not made visible, i.e. are not unmasked to either of the two     readers. In year two, the risk levels obtained from the RiskAnalyzer for half of the studies     are unmasked to the two readers while grading the image.      Access to all study data and processes follows a role-based design. The clinical staff will     have access only to clinical data but not the technical data. The technical team will have     access to the technical data only but not the clinical data. The study coordinator will have     access to all data. The use of computers will adhere to the Guidance for Industry     Computerized Systems Used in Clinical Investigations and applicable sections of 21 CFRs part     11.   "
127643|NCT01614314|"     The purpose of this study was to compare the performance of nursing undergraduates in     dressing of tunneled central venous access in the simulator, according to the aid of a     preceptorship or an auto-instructional guide.   "
127644|NCT01614301|"     A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of     temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose     trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma      Phase I: To determine the dose of temsirolimus to be used in phase II part of the study      Phase II:      To determine overall survival Secondary objectives        -  To evalulate response rate        -  To evaluate time to progression (TTP)        -  To evalulate time to partial response (time to PR or better)(TPR)        -  To evaluate quality of life        -  To evaluate tolerability and safety   "
130585|NCT01575756|"     The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy     and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital     fibrinogen deficiency   "
127646|NCT01614275|"     The purpose of this study is to determine the extent to which technology may be used to     provide (a) state-of-the-art assessment and intervention for children diagnosed with autism     and (b) parent and tutor training for those who care for these children.      Children with autism often have problems with social interaction, language, and repetitive     behavior (e.g., hand flapping and body rocking). Without early and intensive treatments, the     long-term outcomes for children with autism are not very good; therefore, it is very     important that effective treatments are started as soon as possible. Research has shown that     Early Intensive Behavioral Interventions (EIBI) is an effective treatment for autism.     Although EIBI is effective, most children with autism in military families do not receive     EIBI because there are few professionals and paraprofessionals that are appropriately trained     to do this, especially in the remote areas where military families tend to serve. The     investigators want to show that web-based technologies (e.g., web-cams and internet-protocol     cameras) can be used so that professionals in one place can treat children with autism     anywhere in the world. The investigators also expect that providing these services will help     children with autism improve their language, social, and academic skills. The investigators     expect that the gains made by the children will help relieve many daily stressors and worries     that families with children with autism have.      Children with autism who lack adaptive skills require constant help and supervision from     parents. Thus, the improvements in the child's functioning will allow the child to become     more independent and decrease parent stress associated with the need to constantly watch and     help the child. Because EIBI services produce lasting improvements long after the     intervention has ended, this project will provide both short-term and long-term benefits to     the children who participate in the study, which will provide lasting relief to these     dedicated military families.      In the long-term, this project may really change the way in which all (military and     non-military) children and families get effective services that they cannot get now. Also,     the results may help other professionals and researchers in psychology and medicine. That is,     the results should be helpful to any kind of service that uses parent training and     paraprofessionals. Most importantly, these services will improve the overall functioning of     the children with autism and decrease the overall stress on these families as they continue     to serve our country.   "
127647|NCT01614262|"     Continuous glucose monitoring (CGM) technology has advanced the treatment of people with     diabetes, however to date this technology had been primarily limited to use in patients     treated with insulin. CGM is a powerful tool that has the potential to enhance the care of     patients treated with agents other than insulin; however this has not been tested. The     purpose of this study is to determine whether improved glycemic control can be achieved     through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral     anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to     determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical     outcomes in patients with T2DM treated with OADs is warranted.   "
127648|NCT01614249|"     Fish oil omega-3 supplements provide essential nutrients for brain health and functioning.     These nutrients have been proven to be effective in reducing depressive symptoms. They have     also been found to be effective and well tolerated in reducing the bad fat accumulation among     patients infected with human immunodeficiency virus (HIV)and are using highly active     antiretroviral treatment. The role of this nutritional supplement in combating depression     among pregnant women who are living with HIV infection has however not been established. Yet,     currently, more than 2 million pregnant women are estimated to be living with HIV infection     globally. In Kenya, about 9.0% of pregnant women are HIV-seropositive.      In this study, it is hypothesized that there is no difference in the levels of depressive     symptoms among HIV infected pregnant women who are taking omega-3 fish oil supplements and     those taking a placebo.      The study will therefore seek to ascertain that taking omega-3 fish oil nutritional     supplement has a significant positive effect on depressive symptoms among HIV infected     pregnant women, compared to a placebo.   "
128040|NCT01609127|"     This study is being conducted to compare the efficacy and safety of tesetaxel administered     once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive     weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in     a 21-day cycle.   "
127649|NCT01614236|"     Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most     common questions asked by patients pertains to the amount of pain they will experience after     surgery how long it will last and how good will it be controlled. Pain concerns the surgical     team as well, because of its correlation with clinical outcomes and patients' satisfaction     rate . Studies have shown that negative clinical outcome with regard to pain control includes     decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension,     myocardial ischemia, transition into chronic pain, poor wound healing, and psychological     sequelae .   "
127650|NCT01614223|"     Plantar fasciitis presents clinically as pain in the inner heal, which is the result of     degeneration of the plantar fascia, an arch supporting ligament of the foot. It manifests     predominantly in those subjected to sustained weight bearing or repetitive pounding     activities. Plantar fasciitis is the most common cause of inferior foot pain. Although most     cases resolving within 6 months, traditional treatment regiments such as orthotics and     physiotherapy are occasionally unsuccessful in treating this limitation leading to chronic     symptoms (Neufeld & Cerrato, 2008; Rompe, 2009; Roxas, 2005).      Platelets are central players in clotting, inflammation and the wound healing response.     Research has shown the potential of platelet rich plasma to accelerate wound healing in a     variety of conditions including maxillo-fascial and plastic surgery, chronic wound healing     and orthopaedics. Autologous Conditioned Plasma (ACP) is a novel treatment that may     accelerate the healing of injured tissue. Treatment with ACP involves taking a blood sample     from the patient, isolating the platelets and injecting them back into that patient at the     injury site   "
127651|NCT01614210|"     The purpose of the study is to see if tumors respond to endocrine therapy by taking a total     of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA     (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.   "
127652|NCT01614197|"     This is a phase I study of temsirolimus (Torisel) combined with dexamethasone,     cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL),     lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).   "
127653|NCT01614184|"     The study goal is to develop a new method of intraoperative lymphatic mapping with     fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.   "
127654|NCT01614171|"     Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of     childhood osteoporosis and congenital blindness for which new treatments are needed. We have     found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that     growth hormone therapy will improve muscle mass and bone strength in OPPG.   "
127711|NCT01613417|"     This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated     comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects     with brain tumors to confirm the identical overall technical and diagnostic performance of     the two MR contrast agents.   "
127655|NCT01614158|"     This present research project intends to collect five quantitative test series:        -  perimetric examination using static stimuli, assessing the entire (80 degree) visual          field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/          magnitude of the visual field defect and its variability within the cohort and over time        -  D-BCVA, using FrACT [Bach 2007] and EDTRS chart [Ferris 1982]        -  RAPD (using swinging flashlight test).        -  IOP (using applanation tonometer)        -  RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic          disk morphology will be documented by fundus photography. This assessment of the          above-mentioned data is needed in order to allow for estimation of the spontaneous          course / fluctuation of the (quantified) functional and morphometric parameters of the          N-AION patients during the follow-up period. This is essential for the estimation of the          sample size of the subsequently intended SINN study, that is intended to compare          different therapeutic strategies in N-AION patients.   "
127656|NCT01614145|"     Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in     cerebrospinal fluid samples of immunocompromised patients for identification of central     nervous system aspergillosis.   "
127657|NCT01614132|"     The purpose of this study is to determine whether a combination of a radiochemotherapy     (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in     adult patients with medulloblastoma is tolerable.   "
127658|NCT01614119|"     While the exercise responses are classically described at the cardiorespiratory and muscle     levels, recent data suggest that the brain is also significantly stressed by exercise and may     even participate to performance limitation. In hypoxia in particular, cerebral responses to     exercise may be altered and promote performance reduction during endurance exercise. In the     present study, the investigators used innovative approaches to assess cerebral perturbations     associated with exercise in hypoxia.   "
127659|NCT01614106|"     This study will evaluate the efficacy of an integrated Retention Clinic in achieving     virologic suppression among HIV-infected cocaine (including crack) users by using a two-group     randomized, prospective trial. Eligible participants will be randomized to one of the     following two groups: 1) Retention Clinic or 2) Treatment as Usual. The intervention     (Retention Clinic) group will receive up to 11 Patient Navigator sessions over a 6 month     period and 9 sessions of substance abuse treatment over a 3 month period. Follow-up     assessments will be conducted at 6 and 12 months post-randomization. Medical records will be     reviewed to document use of HIV care, drug treatment and mental health services during the     study period. A total of 360 HIV-infected individuals who report cocaine (including crack)     use will be randomized across both sites (Miami, FL, and Atlanta, GA). Primary hypothesis is     that more participants randomized to the Retention Clinic will have undetectable viral load     than will participants randomized to the treatment as usual group.   "
127660|NCT01614093|"     The objective of this study is to test a single dose of intranasal oxytocin, compared to     placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety     signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot     paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention     or treatment for weight gain and overeating in people with schizophrenia.   "
127684|NCT01613781|"     There have been reports of monitoring LSR during MVD surgery helps predicting the clinical     outcome of MVD. However, there have been no evidence of which degree of partial neuromuscular     blockade should be performed during LSR monitoring under sevoflurane anesthesia. Therefore,     the investigators performed a randomized controlled trial to evaluate the effect of different     degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.   "
127661|NCT01614080|"     intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic     stroke. This effect is due to an early recanalization secondary to the lysis of the clot.     However this effect may be counterbalanced by the increased risk of bleeding and also the     neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain     (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to     determine whether the functional outcome after treatment by iv rt-PA depends on the ratio     sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain     haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).   "
127662|NCT01614067|"     In couples with infertility secondary to Diminished Ovarian Reserve, the investigators     hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist     (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.   "
127663|NCT01614054|"     The purpose of this study is to show that a patient-centered survey asking about smoking     habits, with the option for nicotine replacement therapy (NRT) will increase the prescription     rates among health care providers (HCP). The investigators also believe that this     intervention can also lead to increased referrals to smoking cessation clinics and ultimately     increase rates of smoking cessation.   "
127664|NCT01614041|"     The purpose of this study is to evaluate the efficacy and safety of comparative high dose     Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.   "
127665|NCT01614028|"     This study aims to investigate short-term outcomes following the use of two femoral stems     used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.   "
127666|NCT01614015|"     The proposed effectiveness study examines differences in treatment outcomes of an     observation-based supervision (BOOST) versus supervision as usual (SAU). The study will be     implemented within 16 teams delivering FFT services at 11 sites in the California Institute     of Mental Health (CIMH) system. The 16 FFT therapist teams will be randomly assigned either     to BOOST or SAU. Each team will have 3 therapists who will treat 6 families for a total of 18     families per team. Thus, each condition will include 24 therapists who will treat 144     families. The project will be implemented in four staggered waves to establish a more even     rate of data collection and treatment implementation to enhance the feasibility of the study     by keeping staffing and project costs more constant across the 5-year project. Each wave will     involve 4 FFT teams, 2 receiving BOOST and 2 receiving SAU. Teams will be randomized to     supervision conditions. Outcome assessments of parents and adolescents will be conducted at     baseline and at 4 months and 16 months after treatment initiation.   "
127672|NCT01613937|"     Objective: The current study examined the effectiveness of a culturally-appropriate     adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes     risk in Latinas with a history of gestational diabetes mellitus (GDM).      Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3     years participated in an 8-week group-based, peer-educator led lifestyle intervention based     on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and     self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up     (month-6).      Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the     development of type 2 DM.   "
127673|NCT01613924|"     The aim of our study is to determine the time to resolution of individual acne lesions using     a popular handheld heat based device in comparison to no treatment and to standard topical     therapy with benzoyl peroxide in order to determine its effectiveness in the spot treatment     of acne vulgaris. Patient satisfaction and potential side effects will be examined as well.   "
127674|NCT01613911|"     This study will help describe how the human brain works when a person sees something, hears     something, learns something, or thinks about something by recording brain activity that     occurs when the person does a series of computer tasks. This study will be offered to people     who are in the hospital to be monitored for epilepsy by using electrodes placed in the brain.     The study will record brain activity that occurs when a patient does a memory task, for     example.   "
127685|NCT01613768|"     Researchers are doing a research study to examine the use of eribulin (eribulin mesylate) in     patients with salivary gland cancer. Researchers want to know if eribulin is safe and     effective in treating salivary gland cancer.   "
128631|NCT01601405|"     The objectives of the study were:        1. To show that a single dose of YF476 blocks gastrin receptors in healthy subjects        2. To show that YF476 retains its ability to block gastrin receptors after repeated dosing          despite losing its ability to suppress gastric acidity.   "
127675|NCT01613898|"     The aim of the proposed study is to evaluate the risk for cardiovascular disease and     'atherogenic' features of the serum in CTX and to determine preclinical atherosclerosis. The     study will include an extensive assessment of lipoprotein profile and carotid artery     intima-media thickness (cIMT) measurement.      Lipid and lipoprotein profiles will include novel tests such as direct measurements of     apolipoprotein A1,B,C2,C3 plasma levels, lipoprotein (a) levels, highly sensitive C-reactive     protein levels and PLAC test that measures the levels of lipoprotein-associated phospholipase     A2-a vascular-specific inflammatory enzyme implicated in the formation of atherosclerosis   "
127676|NCT01613885|"     The purpose of this study is to gain better understanding of how the immune system works in     twins with and without allergic disease. Healthy volunteers are not specifically targeted.     Healthy non-allergic study participants may be found through the course of evaluation for the     presence of allergies.   "
127677|NCT01613872|"     This study is studying the effects of Mindfulness Based Stress Reduction (MBSR), a standard     protocol of gentle yoga and breath meditation, on patients with Traumatic Brain Injury (TBI).     The investigators are testing whether this intervention can help improve the stress response     and increase resiliency and mindfulness for patients with TBI, which may lead to improved     symptoms and neurocognitive function.   "
127678|NCT01613859|"     Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is     an integral part of hemodynamic monitoring of critically ill patients whether it is done     directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies     to support the cardiovascular system in critically ill children with multi organ dysfunction.     Because of the side effects involved in measuring cardiac output directly, intensive     monitoring of patients is currently limited to an integrated assessment of tissue perfusion,     oxygen delivery and cellular health both at regional and global levels. Currently available     methods of measuring CO have their limitations and complications, and are not used routinely     for bedside monitoring. Therefore, the investigators propose to use a newly developed method,     termed COstatus for the monitoring of CO in patients admitted to PICU.   "
127679|NCT01613846|"     Sorafenib and pazopanib are both effective and promising treatments for advanced Renal Cell     Carcinoma (RCC). Both drugs are registered for this indication. No prospective comparative     data in advanced RCC (or other indications) have been published. A search in the     clinicaltrials.gov database did not reveal any planned or ongoing studies. As sequential     therapy is now the standard of treatment for advanced RCC it is important to evaluate in     clinical trials what the value of different sequential strategies is. This needs to be done     every time new agents are introduced into the treatment armamentarium. As there are no data     yet on the sequential use of sorafenib followed by pazopanib or vice versa, this sequence,     however, will most certainly be used in daily practice, it is required to examine efficacy     and safety of this sequential approach in a clinical trial in a randomized setting.      Therefore, the investigators have designed an open randomized study in patients not     previously treated for advanced RCC. Suitable patients will be randomized (1:1) in 2 groups.   "
127680|NCT01613833|"     Osteoarthritis (OA) is the irreversible degeneration of articular cartilage and underlying     bone. It poses a major healthcare problem as it is the leading cause of joint disease and     disability in the United States. It was traditionally thought that OA was a consequence of     aging and joint trauma. However, it is now thought that OA is a result of the interplay of     multiple genetic, biomechanical, and biochemical factors that disrupt the normal homeostasis     of cartilage, bone, and synovium.      OA is classified into two groups, primary and secondary. Primary OA is classically     polyarticular and peripheral while secondary OA can commonly be attributed to a specific     cause, limited to a singular joint, and a result of trauma. It is known as post-traumatic OA     (PTOA). Other causes of secondary OA include congenital disorders, calcium pyrophosphate     dehydrate deposition disease, and other diseases. Regardless of classification, genetic     variation in the normal metabolism of cartilage and bone is thought to play a role in the     progression of OA. Furthermore, the polyarticular presentation of primary idiopathic     osteoarthritis suggests that it may have a stronger genetic component as compared to     secondary OA, indicating a deviation from normal cartilage and bone homeostasis.      Matrix metalloproteinases (MMP) and their inhibitors take part in the metabolism of cartilage     and bone. MMPs are enzymes that catalyze the degradation of elements within joint spaces     while their inhibitors cease this activity. Alpha-2-Macroglobulin (A2M) is a     naturally-occurring plasma glycoprotein that functions throughout multiple tissues and     extracellular spaces as a protease inhibitor but does not normally reach high levels within     the intra-articular joint space. A2M is believed to modulate the systemic inflammatory     response by its ability to bait, trap, and clear various MMPs and cytokines. Concentrated A2M     directly addresses the roles of cytokines and catabolic enzymes known to participate in the     development of osteoarthritis. Cytonics has shown that A2M can inhibit cartilage degradation     in vitro. As the role of MMPs and protease inhibitors have emerged as key components of OA,     the investigation of regulators of MMP has become of interest to elucidate the pathogenesis     and possible novel treatments of OA.      This study aims to measure and correlate the levels of alpha-2-Macroglobulin (A2M) in plasma     and knee joint OA between primary post-traumatic (PTOA) and secondary osteoarthritis groups.   "
127681|NCT01613820|"     Ketamine infusions resulted in an acute reduction in global depression scores and in severity     of suicidal ideation. Scopolamine infusions produced also a significant improvement in     depression that was sustained over time.      We therefore plan to investigate the feasibility and efficacy of open-label repeated     intravenous administration of ketamine and scopolamine combined in this population of     severely depressed, treatment-resistant patients. The results from this study could lead to     the development of new strategies for the treatment of patients with TRD.   "
127682|NCT01613807|"     Humalog® Mix50/50TM administered as 3 injections daily is equivalent to Humalog® plus Humulin     N® insulin administered as 6 separate injections daily in terms of glucose control, but may     have some advantages due to increased ease of use.   "
127683|NCT01613794|"     Epidemiological studies have shown a 2-3 fold increased long-term risk of arterial     cardiovascular disease after venous thrombosis, most predominant in the first year following     initial venous thrombosis. The results of recent observational studies that showed 40-50%     risk reductions for first venous thrombosis occurrence when using a statin are in this aspect     promising. The results are also somewhat surprising, because the mechanism behind this effect     is unclear. Dyslipidemia may be the most plausible explanation to be considered. However, as     dyslipidemia is not related to an increased risk of venous thrombosis, it is unlikely that     statins decrease venous thrombosis risk by lipid lowering activities. Recent observations     indicate that coagulation can activate the initial formation of atherosclerosis. Our     hypothesis is therefore that the coagulation profile in persons with venous thrombosis is     improved when using a statin, ultimately leading to less atherosclerosis: another well known     property of statin use.   "
127716|NCT01613352|"     The aim was to assess the patient compliance and medical and psychosocial effects of same day     hospital discharge after breast conserving surgery and sentinel node biopsy only.   "
127686|NCT01613755|"     The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole     are often used concomitantly in patients with diabetes who have suffered a transient ischemic     attack or stroke. It has recently been suggested that the gastrointestinal absorption of     metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has     been reported to inhibit hENT4 transport in vitro. The aim of this research proposal is to     study the pharmacokinetic interaction between metformin and dipyridamole. The investigators     hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. If this     hypothesis can be confirmed, then the results of this study can explain in part the high     variability in plasma metformin concentrations in patients treated with diabetes, and can be     used to optimize pharmacotherapy in patients with diabetes.   "
127687|NCT01613729|"     The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily     with Rosuvastatin 10 mg once daily by assessment of the number of patients with     hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.   "
127688|NCT01613716|"     This study will examine the use of the dexamethasone implant (Ozurdex) in patients with     macular edema associated with an epiretinal or preretinal membrane requiring surgical     intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will     be placed in the eye. Patients will be followed for 1 year.   "
127689|NCT01613703|"     The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in     healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for     TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the     plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952     in healthy subjects.   "
127690|NCT01613690|"     The purpose of this study is to see how the body processes and gets rid of NVA237 in people     who have impaired kidney function compared to people whose kidney function is normal.   "
127691|NCT01613677|"     This is a single arm open label phase II trial to evaluate the oral daily use of BKM 120 in     patients with recurrent unresectable or metastatic cervical cancer after palliative cisplatin     based regimen failure.      A complete treatment cycle is defined as a 28 days period.   "
127692|NCT01613664|"     Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice     in the surgical management of patients with morbid obesity. However, this restrictive     procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage     (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently     reliable technique to prevent these complications.   "
127693|NCT01613651|"     This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP)     with pelvic drain placement to see how well it works compared to RALP without pelvic drain     replacement in reducing adverse events after surgery in patients with prostate cancer.   "
127694|NCT01613638|"     Congenital malformations rate is about 3% in France. There are already 5 registries in     France, covering about 16% of French births: Paris Registry, (about 38 000 births /year),     Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000     births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim     of malformation registries is to carry out epidemiologic surveillance of congenital     anomalies. The objectives are mainly to provide essential epidemiologic information on     congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an     information and resource centre regarding clusters, to provide data for research related to     the causes and prevention of congenital anomalies.      A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille     et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to     record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida,     diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those     observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence     regarding congenital heart diseases and hypospadia. In this study the investigators could not     determine whether this was due to a real higher frequency or to a particular exhaustiveness     in the recording methodology.      There are hypothesis about the role of intrauterine exposure to pesticides, known as     endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive     agricultural area, and it is thus worth studying the impact of pesticides exposure on     congenital anomalies.      There are also hypothesis on the impact of occupational exposure to solvents on congenital     anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8%     pregnant women in France) on oro-facial clefts and congenital heart diseases.      The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study     the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of     congenital malformations diagnosed at births, by measuring the exposure both directly in     meconium, and indirectly by questionnaires.      Secondary objectives are to study other risk factors such as medicine intake, pregnancy     illness…   "
127712|NCT01613404|"     The purpose of the study is to compare the 90 day and 12 month composite end point of death     (all-cause mortality) and hospitalization in incident hemodialysis patients randomized to     receive support from a dedicated case manager (intervention group) versus those not receiving     support from a dedicated case manager (control group).   "
127695|NCT01613625|"     Elastography is a emerging imaging technique that has demonstrated high reliability in the     assessment of tissues stiffness and quantification of fibrosis particularly in adult's     livers. This ultrasound exploration has no secondary effects. There is no study published in     the pediatric population concerning the role of ultrasound elastrography in kidney. The aim     of this study is to look for a correlation between the elastography's results and the kidney     fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential     diagnostic and/or prognostic role in the management of these patients which would limit     invasive biopsy procedures.   "
127696|NCT01613612|"     The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell     implantation combined with core decompression to single core decompression for the treatment     of avascular necrosis of femoral head.   "
127697|NCT01613599|"     This prospective observational study will evaluate the long-term safety of MabThera/Rituxan     (rituximab) in participants with granulomatosis with polyangiitis (Wegener's) or microscopic     polyangiitis. Data will be collected for a maximum of 4 years from participants initiated on     MabThera/Rituxan therapy by their physician according to prescribing information.   "
127698|NCT01613586|"     In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared     with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial     Cystitis.   "
127699|NCT01613573|"     The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG     somatropin, which administered once per week, compared with the daily used somatropin, and to     evaluate the safety and possibility to replace daily used somatropin.   "
127700|NCT01613560|"     This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study.     The objective of this study is to prospectively verify the relation of efficacy of     neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary     adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant     endocrinotherapy.   "
129792|NCT01586234|"     The primary goal of this study is to determine if excimer laser smoothing of the cornea     before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative     Best Spectacle Corrected Visual Acuity (BSCVA).   "
127701|NCT01613547|"     This study will be conducted as a randomized, double-blind, placebo-controlled trial to     compare routine antibiotic prescription vs. no routine antibiotic prescription in the     management of uncomplicated cases of severe acute malnutrition treated in the community in     terms of nutritional recovery. The investigators hypothesize that there will be no     significant difference in terms of the risk of nutritional recovery among children     uncomplicated cases of severe acute malnutrition treated in the community that receive     routine antibiotic prescription and those who receive no routine antibiotic prescription.   "
127702|NCT01613534|"     The aim of this study was to compare the efficacy and safety of two treatment regimens: argon     plasma coagulation (APC) alone and APC in combination with sucralfate administered for     chronic hemorrhagic radiation proctopathy.   "
127703|NCT01613521|"     This study is to assess how patients respond to their treatment for cervical cancer. This     research does not involve a specific treatment for the cancer that will be recommended by the     doctor and may include radiation therapy and/or chemotherapy. This is a separate research     imaging study designed to assess how patients respond to their treatment for cervical cancer.   "
127704|NCT01613508|"     The primary aim of the study is to compare the results of an established, successful     procedure, which is total hip arthroplasty through a mini-posterior approach to a less     studied - increasingly popular procedure, which is total hip replacement through the direct     anterior approach utilizing the orthopedic table.   "
127705|NCT01613495|"     The purpose of this study is to learn more about how octreotide (Sandostatin LAR® Depot)     affects levels of ghrelin, hunger, and body weight in people with Prader-Willi Syndrome.   "
127706|NCT01613482|"     Evaluate the survival without metastasis in patients treated by Trastuzumab in association     with other chemotherapies for a breast cancer expressing HER2-NEU.   "
127707|NCT01613469|"     This study will assess the complete clinical response (no clinical evidence of remaining     disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal     opening after radiation therapy given at the same time as chemotherapy over a 6 week period,     followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins     with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6     weeks for one year.   "
127708|NCT01613456|"     The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae     CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the     irritable bowel syndrome (IBS)   "
127709|NCT01613443|"     Concentration determinations of anticoagulants require plasma instead of whole blood, and     results are not immediately available to clinicians. Monitoring anticoagulants concentration     along with bedside methods may provide an alternative guide for administration of the NOAC.      The purpose of this investigation is to compare bedside coagulation assays in whole blood     with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with     therapeutic dosis of NOAC.   "
127710|NCT01613430|"     The overall goal of the COACH study is to conduct a comparative effectiveness trial to assess     the effectiveness of trained, participant-designated health coaches versus traditional health     education efforts on cancer screening among African American older adults. We hypothesize     that members of older adults' extended families can be trained to be effective coaches who     support them through the cancer control spectrum, i.e., prevention, screening, diagnosis and     treatment. This research objective is guided by the theoretical model of the PRECEDE-PROCEED     conceptual framework that has been widely adopted in health promotion. The target     jurisdictions for this study are Baltimore City (BC) and Prince George's County (PGC),     Maryland. The study is anchored in community-based participatory research (CBPR) principles,     involving community members in all its phases. The CBPR component is guided by Community     Advisory Groups (CAGs) representing key stakeholders in the two jurisdictions. The CAGs are     essential in determining the questions included in data collection instruments, mechanisms of     recruitment, interpretation of findings, and dissemination of results within the target     communities.   "
127714|NCT01613378|"     This multi-center, non-interventional study will evaluate the pattern of usage in clinical     practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients     initiated on treatment with tocilizumab according to the licensed Canadian product monograph     recommendations will be followed for 12 months from the start of treatment.   "
127715|NCT01613365|"     Despite improvement of per and postoperative management, major pulmonary surgery continues to     carry out a high morbidity with a significant mortality. Among postoperative complications,     respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and     serious, as well as being the primary cause of hospital death, after major pulmonary     resections. Vast majority of these complications are notoriously infectious and should be     considered as hospital-acquired infections. These complications result in a dramatic     increased of substantial hospital costs in term of length of hospital stay, antibiotics and     morbidity. Current management of these complications stands on antibiotics, oxygen supply and     physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in     near 25 % of cases.      Recent data have suggested that proximal airways colonizations could be an essential first     step in the pathogenesis of theses respiratory failures. Previous works have long     demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer     patients. These colonizations could act as a major predisposing factor to these postoperative     respiratory failures. Because distal airways and lung parenchyma are free from bacteria at     the moment of the surgery, respiratory complications should be the result from contamination     by potential microorganisms belonging the upper aero-digestive tract. Consequently,     decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first     days after surgery could have a beneficial advantage in the prevention of these     complications. This decontamination has been demonstrated to be effective in critically-ill     patients in intensive care unit, in cardiac surgery and in esophageal surgery.     Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly     reduced the rate of postoperative global hospital-acquired infections and respiratory     infectious as well. To date, data on the efficacy of this decontamination protocol in major     pulmonary resections are not available.   "
127717|NCT01613339|"     Affected balance capacity is common after a stroke due to paresis and sensory disturbances.     The affected balance capacity may cause walking disturbances, falls and decreased mobility.     Balance may be improved by physical therapy. A possible method for balance training is body     awareness therapy, that was introduced in Sweden by Jacques Dropsy and Gertrud Roxendal.     Earlier body awareness therapy was mostly used in psychiatric care but in the recent years     the method has been used for people with long-tern pain, amputations and multiple sclerosis.     Body awareness therapy includes exercises in lying, sitting and standing. Focus of the     exercises are awareness of one´s movement behaviour, breathing patterns, resources and     limitations. Postural control is an essential part in the exercises. Body awareness therapy     could be used for people with stroke as a way to improve postural control. The aim of this     study is to investigate if balance training using body awareness therapy can improve balance     and walking in people after stroke. The interventions consists of body awareness therapy once     a week for 8 weeks.   "
127718|NCT01613326|"     This study compared the efficacy and safety of NVA237 with tiotropium in patients with     moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.   "
127719|NCT01613313|"     The purpose of this research is to evaluate the safest and most effective dose of a Food and     Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of     varying sizes that occur commonly in the adult population). The fat in the lipoma is like     normal fat except that it is enclosed in a balloon-like structure which is made of collagen     (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks     down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size     of the lipoma or removing it.   "
127720|NCT01613300|"     The aim of this study is rate of acute graft-versus-host disease II-IV measured at day     +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk     non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant   "
127721|NCT01613287|"     This clinical investigation is a medical device trial to examine the safety and efficacy of     TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used     exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy     (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary     Arterial Hypertension and WHO functional classification III.   "
127722|NCT01613274|"     The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon     resection surgery decrease the time to first flatus, bowel movement and length of stay in the     hospital.   "
127723|NCT01613261|"     This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in     Adult Patients With Advanced Nonhematologic Malignancies   "
127724|NCT01613248|"     The purpose of this study is to assess the effectiveness, safety and tolerability of a range     of doses of MK-1602 versus placebo in the treatment of acute migraine.   "
127725|NCT01613235|"     The objective of this multi-centre, randomized controlled trial is to investigate the outcome     after induced hypertension versus no induced hypertension in patients with delayed cerebral     ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH), and to assess whether induced     hypertension results in improved cerebral blood flow (CBF) as measured by means of     perfusion-CT.   "
127726|NCT01613222|"     A 2 phase study to test the accuracy of SpO2 sensors with various patient monitors,     co-oximeters, and modules.   "
127727|NCT01613209|"     The investigators want to find out whether a recently introduced combination of two blood     pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering     effect than a single active substance. In addition the investigators want to find out whether     there is a difference in the changes in blood pressure over the course of a day depending on     the time when the medications are taken (in the morning or at night). Male and female     patients over 18 years of age may participate.   "
127728|NCT01613196|"     Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence     of bacteriological cure is difficult to be obtained raising the need for other therapeutic     assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in     Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory     cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in the     foci of TB during treatment permitting a non-invasive monitoring of therapeutic response. The     main objective is to describe the evolution under treatment of the FDG uptake in PET imaging     in TB foci in patients cured from lymph node and bone TB. Secondary objectives are to compare     the decrease of FDG uptake according to type of location, to define the frequency of     localizations revealed by FDG-PET and their impact on therapeutic management at the beginning     and the end of treatment, and to describe the evolution of PET in patients not cured.   "
127747|NCT01612949|"     The aim of this project is to develop a computer algorithm that can accurately predict how     easy or difficult it is to intubate a patient based upon digital photographs from three     different perspectives. Such an application can provide a consistent, quantitative measure of     intubation difficulty by analyzing facial features in captured photographs - features which     have previously been shown to correlate with how easy or how hard it would be to perform the     intubation procedure. This is in contrast to established subjective protocols that also serve     to predict intubation difficulty, albeit with lower accuracy. A digital application has the     potential to decrease potential complications related to intubation difficulty and increase     patient safety.   "
127733|NCT01613131|"     Hormonal treatment of perimenopausal women has frequently utilized oral contraceptive pills     (OCPs). Because of their ability to suppress ovulation and establish cycle control, OCPs have     become a popular option, and one that is FDA approved for use until menopause. However, use     of OCPs in women in their 40's and 50's carries significant cardiovascular risks. Venous     thromboembolism risk is 3-6 fold greater in OCP users, and the risk of myocardial infarction     (MI) is approximately doubled in OCP users over the age of 40. This occurs at an age where     the background population risk of MI begins to increase, such that the absolute number of     cases rises substantially. Women with additional risk factors for cardiovascular disease have     a much greater risk for MI (6-40-fold) in association with OCPs. There are also large     subgroups of midlife women who are not candidates for OCP use, such a smokers and     migraineurs. Moreover, the trend towards lower estrogen dosing with OCPs containing 20     micrograms of ethinyl estradiol has not led to a detectable decrease in thromboembolic risk.      Because of their increased potential risks, it is appropriate to seek alternatives to OCPs     and to explore lower doses of hormones to relieve perimenopausal symptoms that occur prior to     a woman's final menses. Recent evidence indicates that the hypothalamic-pituitary axis of     reproductively aging women is more susceptible to suppression by sex steroids that previously     believed. It is possible that hormone doses as low as 50 micrograms of transdermal estradiol     (TDE) can suppress the hypothalamic-pituitary axis of midlife women. It is also tempting to     speculate that the low but measurable circulating doses of levonorgestrel that are present     when a woman uses the Mirena intrauterine system (IUS) can contribute to or even     independently suppress the hypothalamic-pituitary axis, and reduce the hormonal fluctuations     that result in worsening of perimenopausal symptoms. The combination of low dose TDE plus     Mirena may therefore confer superior symptom control as well as contraceptive effectiveness,     at far less risk.   "
127734|NCT01613118|"     This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor     antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is     safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).   "
127735|NCT01613105|"     In this prospective, non interventional, observational Post Marketing Survelliance study data     are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of     sulfonylurea under daily life treatment conditions.Specifically investigated is the influence     of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when     added to an already existing sulfonylurea therapy.The study is planned to carried out in     25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance study     will be performed with commercially available medication prescribed within regular practice     of the physician. No other examination will be performed than would be done without Post     Marketing Survelliance study.   "
127736|NCT01613092|"     The goal of the pilot study is to compare whether a centre-wide policy of incremental     antibiotic therapy will reduce pacemaker infection compared to a policy of conventional     antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This     pilot study will provide feasibility information for a larger cluster randomized crossover     design (CRCD).   "
127737|NCT01613079|"     Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the     treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized,     prospective multi-center clinical trial. Observation period of 24 weeks.   "
127738|NCT01613066|"     Cord blood (CB) from an unrelated donor is increasingly used an alternative source of     hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched     donor. However, the utilization of single-unit CB for transplantation of adult patients has     been impeded by the low number of nucleated cells available from individual CB units. Direct     intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose     problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a     phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult     patients with advanced or high-risk hematological malignancies   "
127739|NCT01613053|"     Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.   "
127740|NCT01613040|"     This multiple-center, multiple-dose, randomized, double-blind, double-dummy,     placebo-controlled, positive-controlled, parallel group study will investigate the effect of     RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to     one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C:     placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin     on Day 11. The anticipated time on study treatment is 11 days.   "
127741|NCT01613027|"     This observational study will evaluate the effect on disease activity and the safety in     routine clinical practice of MabThera (rituximab) in participants with active seropositive     rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor     inhibitor (anti-TNF) therapies.   "
127742|NCT01613014|"     The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly     percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to     placebo. A heavy drinking day is 4 or more drinks per drinking day for women and 5 or more     drinks per drinking day for men.   "
127743|NCT01613001|"     To study the first hypothesis, a retrospective cohort analysis of Air Force members from     January 2005 to December 2010 will be performed to evaluate the association of obesity as an     independent predictor variable with musculoskeletal disease as the dependent variable.   "
127744|NCT01612988|"     ICLL01 The BOMP trial: Phase II study of salvage treatment with Bendamustine, Ofatumumab and     MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL).      A study of the GOELAMS / GCFLLC-MW intergroup   "
127745|NCT01612975|"     Following a lung resection procedure, patients have their pleural space drained of fluid that     accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid     pumped depends on the severity of the inflammation. The investigators are conduction this     study to attempt to use painkillers with intrinsic anti-inflammatory action to try and reduce     the degree of inflammation in patients' pleural cavity, thus ensuring patients are discharged     faster, with a greater comfort level, and a hopefully lower rate of admission.   "
127746|NCT01612962|"     In this study, the investigators will perform a retrospective chart analysis of patients that     underwent a bony debridement or amputation in the operating room at Georgetown University     Hospital during 2009-2010 under Drs. Steinberg and Attinger. Chart reviews, medical records     and operative reports via EMR and paper charts will be examined from inpatient records, the     Center for Wound Healing, the Emergency Department as well as other institutions involved in     the care of the subjects to gather data.   "
128482|NCT01603342|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     determine the feasibility of demonstrating a quantifiable change from baseline in punch     biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving     clopidogrel anti-platelet therapy.   "
127748|NCT01612936|"     The specific hypothesis for this study is that there are fundamental differences in T     effector and T regulatory cell responses in the lung to allergens in allergic asthma (AA)     when compared to allergic nonasthmatics (ANA) that account for the difference in clinical     responses. We will address this by comparing T cell responses in AA versus ANA subjects.     These experiments will correlate T cell responses with measures of airway physiology using     state-of-the art lung imaging and examine mechanisms controlling T cell activation in the     airways of AA and the function of airway T regulatory cells during AA.   "
127749|NCT01612923|"     The physical examination before an abortion is usually performed by a physician. However, in     many countries access to physicians is limited. To increase access to safe abortion this     study wishes to examine if midlevel providers such as specially trained midwives can provide     safe abortion services. Midwives in study were specially trained to perform early pregnancy     ultrasound and if needed to consult a physician. The midwife then provided the abortion     service as well as the contraceptive advice. Women were randomized to receive the service     from a midwife or a physician.   "
127750|NCT01612910|"     This study is being done to find out whether a nutritional supplement, called BioResponse-DIM     (BR-DIM [oral microencapsulated diindolylmethane]), improves the survival for women who have     residual cancer cells following surgery after chemotherapy for breast cancer. BR-DIM is an     active ingredient in cruciferous vegetables (broccoli, brussels sprouts and cauliflower).     Consumption of these vegetables has been associated with a decreased risk in several cancers.     Researchers also hope to find out whether different biomarkers (also called markers) in the     blood predict the chance of breast cancer returning. BR-DIM is thought to be effective in     treating stage II-III breast cancer that is triple negative, AR positive (+), and where there     is residual cancer cells in the breast after chemotherapy.   "
127751|NCT01612897|"     The investigators hypothesize that children seen in a clinic that uses a compute based system     known as CHICA, which reminds pediatricians to screen at defined time point for autism, will     be screened more consistently for autism and receive more timely diagnostic a treatment     services.   "
127752|NCT01612884|"     Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize     safety of coronary stenting by reducing heart attacks and repeat interventions while     simultaneously minimizing adverse bleeding events. This study compares the efficacy of two     laboratory guided treatment algorithms to personalize antiplatelet medication choice after     coronary stenting   "
127753|NCT01612871|"     This is a biomedical and prospective study of interventional type. The trial will include 29     patients over a period of 15 months + 24 months of follow up maximum.      The study will be conduct in womens with metastatic invasive breast cancer or locally     advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line     hormone therapy for metastatic breast cancer) is indicated.      The main objective of this pilot study is to evaluate the feasibility to detect in the     circulating blood of patients, before treatment (T0), the presence of the fifteen tissular     microRNAs described in preclinical studies as possibly involved in hormone     resistance/sensitivity.      In parallel of the detection of these specific miRNAs, we will conduct a larger scale     analysis of circulating miRNAs in these patients before (T = 0) and after one month of     treatment (T28).   "
127754|NCT01612858|"     The purpose of this study is to examine the relationship between insulin resistance and     changes in body fat distribution in HIV-infected persons. This study measures insulin     sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the     effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body     fat in this population.   "
127755|NCT01612845|"     The objective of this study was to prospectively evaluate the influence of local application     of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically     repaired tendons in patients with massive tears of the rotator cuff.   "
127756|NCT01612832|"     Background:      Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most     common questions asked by patients pertains to the amount of pain they will experience after     surgery how long it will last and how good will it be controlled. Pain concerns the surgical     team as well, because of its correlation with clinical outcomes and patients' satisfaction     rate. Studies have shown that negative clinical outcome with regard to pain control includes     decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension,     myocardial ischemia, transition into chronic pain, poor wound healing, and psychological     sequelae .      Pain has been found to be one of the three most common medical causes of delayed/aborted     discharge after ambulatory surgery, the other two being drowsiness and postoperative     nausea/vomiting. Despite progress that has been made with regard to postoperative pain     control, and the development of new standards for pain control, many patients continue to     experience intense pain after surgery .      Recent advances in the understanding of the particularities of central sensitization indicate     that it plays an important role in post surgical and post traumatic pain and therefore should     be avoided   "
127757|NCT01612819|"     Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients   "
127758|NCT01612806|"     To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the     treatment of venous leg ulcers (VLUs).   "
127759|NCT01612793|"     This study will look at the safety, improving symptoms and decreasing the length of stay of     patients admitted to the hospital with COPD.   "
131319|NCT01566162|"     This is a 12-week, multi-center, open-label extension study designed to evaluate the     longer-term safety, tolerability and effectiveness of lurasidone for the treatment of     subjects with schizophrenia.   "
127774|NCT01612598|"     Patients enrolled in phase I clinical trials could potentially benefit from palliative care     concurrently, yet limited evidence is available to support such a change in care. The primary     purpose of this study is to test the feasibility of a palliative care intervention (PCI) for     patients participating in a phase I therapeutic clinical trial   "
141837|NCT01427946|"     Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of     retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung     Cancer (NSCLC).   "
127762|NCT01612754|"     Aim of Study: Adverse effects from noise pollution in operation theatres have been throughly     demonstrated. We assessed the impact of a noise reduction program in paediatric surgery.      Methods: A prospective controlled study on 156 operations performed by 16 surgeons was     conducted. The sound levels before and after a noise reduction program based on education,     rules and technical devices (Sound Ear tm) were assessed. Endpoints were spatially resolved     sound levels matched by the surgeon's biometric (saliva cortisol, electrodermal activity) and     behavioural stress responses (questionnaires). These were correlated with mission protocols     and NoiSeQ for individual noise sensitivity.   "
127763|NCT01612741|"     In this prospective, non interventional, observational Post Marketing Survelliance study data     are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of     metformin under daily life treatment conditions.Specifically investigated is the influence of     Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added     to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000     patients from 200 trial sites in India.The PMS study will be performed with commercially     available medication prescribed within regular practice of the physician. No other     examination will be performed than would be done without Post Marketing Survelliance study.   "
127764|NCT01612728|"     Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen     receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over     tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast     cancer. However, approximately half of the women who take this drug will develop significant     joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine should     be taken for 5 years, the joint pain can be so troublesome that up to 13% may prematurely     discontinue it because of the arthralgia, thus sacrificing their best chance of     recurrence-free survival. Nonetheless, neither the etiology nor optimal management of AIA is     clearly understood, leaving both doctor and patient rather frustrated.      The investigators therefore propose to test the hypothesis that AIA can be effectively     treated by a new clinical algorithm, and that effective treatment of the problem will lead to     improved compliance with Aromatase Inhibitor (AI) therapy. The algorithm is a clinical     pathway for treating AIA which incorporates, in a rational and step-wise manner, a series of     interventions based on the available evidence. Interventions include acupuncture, pain     medication, weight bearing exercise, and other commonly used therapies for AIA.      The investigators will enroll 100 women who are beginning adjuvant AI therapy and assess each     woman's baseline joint pains via a questionnaire as well as grip strength measurement. The     investigators will then periodically repeat these tests during AI therapy in order to     systematically quantify and characterize AIA. Those women who develop AIA during the course     of the study will be placed on the clinical algorithm, and the investigators will observe     whether their joint pains significantly improve (as measured by questionnaire and grip     strength measurement) after institution of the algorithm. The investigators will also     determine whether their compliance is improved compared to historical controls, and at least     non-inferior to the women in the study who do not develop AIA. Finally, the investigators     will measure serum estrogen level at baseline and then periodically during AI therapy to     investigate whether more dramatic decline in estrogen level after initiation of an AI leads     to significant AIA and earlier time to onset.      This study targets a very common cause of pain among breast cancer survivors and aims to     offer an effective treatment strategy to alleviate pain and improve quality of life as well     as medication compliance.   "
127765|NCT01612715|"     Cat allergies are a major trigger of asthma. Therapies are being developed to control the     allergic response to cats. We are interested in measuring a type of white blood cell which is     linked to cat allergies, which will help us understand how to use new therapies in people who     suffer from cat allergies and asthma. We will study cat-allergic individuals with stable,     mild asthma who will be exposed to cat allergens. We will measure various white blood cells,     including the cells that are linked to cat allergies, to determine whether the number of     these cells changes following cat exposure. These cells will be measured from the blood and     bone marrow by removing samples using a needle. These cells will also be measured from the     lungs by inserting a bronchoscope into the airways and drawing up fluid containing cells.     This study will improve our understanding of the harmful versus protective role of these     cat-specific cells, and will allow for development of better drugs for treatment of asthma     triggered by cat exposure.   "
127766|NCT01612702|"     This study was conducted to determine the efficacy of an additional preemptive, single,     low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting     (PONV), pain level, and the safety in terms of wound complications in patients managed with     our antiemetic protocol based on Ramosetron following TKA.   "
127767|NCT01612689|"     This is a prospective, unblinded sub-study to the E-30 to gather physiological data.   "
127768|NCT01612676|"     The purpose of this trial is to investigate the potential of FE 202158 as a treatment which     can stabilize blood pressure for treatment of patients in early septic shock.   "
127769|NCT01612663|"     The purpose of this study is to test if specific therapeutic benefits of acupuncture are     mostly attributable to contextual and psychosocial factors, such as patients' beliefs and     expectations.The investigators propose using the 2 acupuncture methods, which refrains from     inserting needles in the affected area, in order to evaluate the short-term and long-term     efficacy of acupuncture in a clinical setting compared with placebo and compared with     invasive needling that does not adhere to correct acupuncture rules.   "
127770|NCT01612650|"     This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a     significant decrease of ultrasound cliches (and radiation exposure)   "
127785|NCT01612455|"     The purpose of this study is to implement and assess a behavioral and structural intervention     in Russia designed to support and motivate HIV-infected narcology heroin dependent patients     (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve     their HIV outcomes. The central hypothesis is that an intervention that involves coordination     between the narcology and HIV systems via HIV case management delivered by a peer to help     motivate and reduce barriers to HIV care will lead to engagement in HIV care.   "
127889|NCT01611103|"     This research is being done to determine whether transcranial direct current stimulation     (tDCS) can improve certain mental abilities. In this research, a 9 volt battery is used to     deliver very weak electrical current to the surface of the scalp while participants complete     cognitive tasks. Our aim is to find out whether tDCS will improve task performance in adults     over the age of 55.   "
127771|NCT01612637|"     Purpose The aim of this study is to examine if a structured pelvic floor muscle training     combined with lifestyle advice with can improve pelvic organ prolapse (POP) symptoms more     than structured lifestyle advice programme alone.      Background Pelvic organ prolapse (POP) is a common condition among adult women and almost one     in ten women experience symptoms caused by POP. The key symptom of POP is seeing or feeling a     bulge in the vaginal opening but POP often gives other symptoms, such as pain, difficulty     emptying the bladder or the bowel, incontinence and sexual problems such as dyspareunia.      A majority of women with POP will be offered reconstructive surgery but the risk of     reoperations is substantial and surgery may cause new symptoms. In one out of four women     surgery does not relieve symptoms and the women have been exposed to unnecessary risk of     complications.      It is therefore important to evaluate the effect of conservative treatments for POP. New     studies have shown that pelvic floor muscle training offered in combination with lifestyle     advice has a significant on POP symptoms and objective measures of POP compared to a     lifestyle advice leaflet alone.      No studies have compared the effect of a combined pelvic floor muscle training and lifestyle     advice programme with a structured programme of lifestyle advice and hypothetically the     structured lifestyle advice programme could have a substantial effect on its own. Our     hypothesis is that the pelvic floor muscle training is a vital component of a conservative     treatment for POP.      Methods In this single-blind randomised controlled study women with POP will randomised to     either a programme of structured pelvic floor muscle training combined with lifestyle advice     or a structured lifestyle advice programme alone. Both groups will receive the same lifestyle     advices through six (separate) lectures within 12 weeks. The training group will be examined     and individually instructed in pelvic floor muscle training before the intervention starts     and they will, in continuation with their lifestyle lectures, perform pelvic floor muscle     training as group training   "
127772|NCT01612624|"     Rationale: Acromegaly is the clinical syndrome that results from an excess of growth hormone     (GH). Craniofacial and hand disproportions due to soft tissue swelling and new bone formation     are highly prevalent in patients with active acromegaly. Besides the cosmetic aspects, these     changes can impair the quality of life because of the significant morbidity with respect to     oral, maxillofacial and hand pathologies as well as respiratory problems such as sleep apnea     and changes in speech. At present it is unclear if these craniofacial and hand     disproportions, sleep apnea and speech changes are (partially) reversible after successful     treatment. Therefore there is no consensus about the information patients should be given     about (partial) recovery of facial and hand disproportions after treatment and how the     follow-up with respect to oral, maxillofacial, respiratory and hand pathology should be     organized. Facial and hand analysis using a 3D stereophotograph and a 3D fusion model of a 3D     stereophotograph and a 3D skull reconstruction via cone beam computed tomography (CT)-scan     makes it possible to investigate the craniofacial changes due to acromegaly in all facial     dimensions together (dentition, bone and soft tissue) and the relational proportions between     these facial structures. 3D stereophotography can do the same for the soft tissues of the     hand. Combined with disease specific and general quality of life (QOL) questionnaires, a     correlation between quality of life and craniofacial and hand disproportions can be     determined. Combined with sleep- and speech analysis, a correlation between sleep apnea,     speech and craniofacial disproportions can be determined.      Primary objective: To investigate the changes in facial- and hand analysis in patients with     acromegaly as a result of medical treatment and pituitary surgery, and to investigate the     changes in relational proportions between facial- and hand structures, incidence and severity     of sleep apnea, incidence and severity of speech changes and QOL.      Study design: a prospective case-control study. Study population: Approximately thirty     patients newly diagnosed with acromegaly . The results of facial and hand analysis, sleep     apnea research and speech analysis of the patient group in different phases of the disease     will be compared to the results of a healthy control group.      Main study parameters/endpoints: Parameters of facial analysis with 3D stereophotography and     cone beam CT and hand analysis with 3D stereophotography , biochemical parameters of disease     activity, disease related QOL assessed by 2 validated QOL questionnaires (,the AcroQol and     RAND-36 ), speech analysis, the results of the voice handicap index questionnaire and     severity of sleep apnea assessed by complete overnight polysomnography and the Epworth     sleepiness scale questionnaire.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: As a result of participating in this study, subjects have to undergo a cone beam     CT. The cone beam CT is associated with exposure to X-ray radiation of 0.069-0.135mSv. This     is the same amount of radiation as the amount of background radiation that each person     receives in 7 days time during daily life. No adverse effects are expected from this amount     of exposure. The investigations will take 10-70 minutes adjacent to every regular outpatient     clinic visit. In addition , for polysomnography, subjects will be investigated overnight one     or three times in 2,5 years, depending on the results of the first screening polysomnography.      Assessment of changes in body appearance, sleep disturbances, speech changes and QOL in a     prospective longitudinal fashion will increase the knowledge of the impact of the disease on     patient perception of well-being and functioning and will help us refine the treatment goals     in patients with acromegaly   "
127773|NCT01612611|"     The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai     injection in hospital results in adverse events or adverse drug reactions.   "
129793|NCT01586221|"     The purpose of this study is to see if group Music Therapy and Physical Therapy will help in     the recovery from stroke. It is hoped that music and physical therapy in a group setting will     help physical, mental, and social well-being.   "
127775|NCT01612585|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in October 2011.      It was funded by China major scientific and technological specialized project for     'significant new formulation of new drugs'.      Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and     coronary heart disease in many Chinese hospitals.      The purpose of this study is to determine adverse drug events or adverse drug reaction in     large sample size 30,000 patients.   "
127776|NCT01612572|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in October 2011.      It was funded by China major scientific and technological specialized project for     'significant new formulation of new drugs'.      Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia     、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children     acute hot diseases in many Chinese hospitals.      The purpose of this study is to determine adverse drug events or adverse drug reaction in     large sample size 20,000 patients.   "
127777|NCT01612559|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in October 2011.      It was funded by China major scientific and technological specialized project for     'significant new formulation of new drugs'.      Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and     angina pectoris in many Chinese hospitals.      The purpose of this study is to determine adverse drug events or adverse drug reaction in     large sample size 30,000 patients.   "
127778|NCT01612546|"     This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating     patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that has     progressed through at least one prior regimen of chemotherapy and cannot be removed by     surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor     cells and is hypothesized to interrupt the growth of tumor cells.   "
127779|NCT01612533|"     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy     of Chinese Medical Sciences in October 2011.      It was funded by China major scientific and technological specialized project for     'significant new formulation of new drugs'.      Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart     disease in many Chinese hospitals.      The purpose of this study is to determine adverse drug events or adverse drug reaction in     large sample size 20,000 patients.   "
127780|NCT01612520|"     The objective of the study is to analyze the effectiveness and the cost-effectiveness of     telecoching in improving glyceamic control and other modifiable risk factors in patients with     type 2 diabetes compared to usual care only.   "
127781|NCT01612507|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     different dose regimens of Ceftaroline   "
127782|NCT01612494|"     This single center, blinded, randomized controlled trial evaluated the use of hypertonic     saline versus normal saline as therapy for the symptoms of pediatric concussion post head     injury.      The study hypothesis was that hypertonic saline would improve symptoms of pediatric     concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale     as compared to normal saline.      The null hypothesis was that there would be no difference in change of reported pain in     either group.   "
127783|NCT01612481|"     Cancer surveillance has a significant cost and generate anxiety for the patient.      It is important to avoid exams that will not modify health support or whose results wont     allow to decide.   "
127784|NCT01612468|"     A randomised, double-blind, placebo controlled study of the effect of liraglutide as an     additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated     type 1 diabetes patients.      Background: Treatment with glucagon-like peptid 1 (GLP-1) agonists liraglutide and exanatide     leads to weight loss and decrease in haemoglobin A1c in oral anti diabetic treated type 2     diabetes patients.      It is estimated that 40-50 % of type 1 diabetes patients in the US suffers from overweight or     poor glycaemic control (HbA1c > 8 %).      Small studies, not placebo controlled, reports effects of adding liraglutide to a group of     well regulated (HbA1c < 7.5 %) normal to overweight insulin treated type 1 diabetes patients     for 24 weeks. A decrease in HbA1c, weight, insulin doses and glycaemic excursions measured by     continuous glucose monitoring was seen.      Primary objective:To investigate the effect of liraglutide 1.8 mg once daily compared to     placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an add-on therapy     to insulin. Secondary objectives:To investigate the effect of liraglutide as an add-on     therapy to insulin compared to placebo on change in:Weight, insulin dose,hypoglycaemic     events, CGM, BMI, body composition, quality of life, treatment satisfaction,food preferences,     meal test, CIMT, PWV and 24 hour blood pressure.   "
127818|NCT01612026|"     In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique     is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used     in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass     graft puncture, and to ensure accurate arterial puncture in patients expected to receive     large doses of blood-thinning medications during or after the procedure. For those     practitioners experienced with ultrasound-guided access techniques, it is considered highly     accurate and easy to use; thus, some physicians routinely use this tool. A well-designed     study is needed to truly assess the accuracy of the ultrasound technique and to determine     whether it may reduce complications of arterial access in vascular patients.      By demonstrating the safest, most accurate and efficient technique for obtaining arterial     access during catheter-based procedures, the investigators could significantly reduce     morbidity and mortality associated with complications of arterial puncture. Length of     hospital stay, management costs and patient discomfort could be reduced by minimizing     complication rates.   "
127786|NCT01612442|"     In Ghana the level of malnutrition is high among children below five years of age,     particularly in rural areas. The objective of the study was to investigate the effects of an     education intervention aimed at addressing poor complementary feeding (CF) practices on the     food intakes and growth of young children in the Upper Manya Krobo district of Ghana.      Interviews and focus group discussions involving community health and agricultural workers,     as well as caregivers of children 6-24 months old were conducted to investigate the     facilitators and challenges to optimal CF practices and education on CF. The trials of     improved practices (TIPs) method was used to test the feasibility and acceptability of     potential education messages among mothers of young children (6-24 months) living in the     study area. Child welfare clinic centers in the area were randomly assigned to one of three     groups which were control, nutrition education and integrated education. Mothers of children     6-24 months in the integrated education group received monthly nutrition education from     community health volunteers and agricultural education from agricultural extension agents for     six months in addition to standard monthly child growth monitoring services from community     health nurses. Mothers in the nutrition education group received monthly nutrition education     from community health volunteers for six months in addition to standard care. Mothers of 6-24     months in the control group received only the standard monthly child monitoring services. The     effects of the educational intervention on maternal knowledge on optimal complementary     feeding, as well as food intakes and growth of young children were determined among 367     mother-child dyads over a period of at least six months. The study hypothesised that mothers     receiving the education would have improved knowledge on good complementary feeding practices     compared to those in the control group. The study also hypothesised that young children in     the integrated education would have better nutrient intakes and growth compared those in the     nutrition education and control groups, and those in the nutrition education group would have     better nutrient intakes and growth than the children in the control group.      From the interviews and focus group discussions, reported initiation of CF was satisfactory,     while other reported practices such as the addition of animal source foods, vegetables and     fruits to young children's diet were found to be sub-optimal. Poverty and maternal time     constraints were identified as the main challenges of optimal complementary feeding, while     farming was seen as a facilitator. Lack of education materials, language barrier, maternal     time constraints and lack of in-service training for health workers were the main challenges     to education on complementary feeding. From the TIPS study, mothers expressed their     willingness to improve the diets of their 6-24 months old children by adding or increasing     the amount of animal source foods, dark-green leafy vegetables and fruits, as well as     increasing feeding frequency daily. However, availability and affordability of protein-rich     foods like animal source foods, groundnut paste and soya beans powder was a challenge for     some mothers.      The intervention did not lead to a significant improvement in maternal knowledge on     complementary feeding practices. However, it showed a tendency to reverse a general     decreasing trend in knowledge among mothers on appropriate complementary feeding practices in     the study area. Significantly more children in the integrated education group consumed animal     source foods compared those in the other two groups when compared at nine months after     baseline. However, the intervention did not improve the general nutrient intakes and growth     of the young children in the study area.   "
127787|NCT01612429|"     This is a pilot study to evaluate the effects of amino acid supplementation on the structure     of certain proteins in the blood of dialysis patients. Patients with end stage renal disease     (ESRD) usually have high levels of urea that may interact with blood proteins and change     their structure by a process known as carbamylation. The investigators are interested in     determining whether carbamylation is linked to adverse outcomes in dialysis patients and have     hypothesized that supplementation with a balanced formulation of amino acids can reduce the     amount of carbamylation that occurs. In this study, dialysis patients (n= up to 30) will     receive intravenous supplementation with an FDA-approved amino acid solution (NephrAmine®,     5.4% amino acids) during regular dialysis sessions (3 times weekly for 6 weeks). During the 6     weeks of therapy and for 2 weeks of follow-up, blood will be drawn from patients' existing     hemodialysis access ports (~60 ml total per month) to measure levels of carbamylated albumin,     amino acids, and standard laboratory values. Patients will be closely monitored for safety     and tolerability of the amino acid therapy. For each treated subject, we will follow an     additional individual that is not receiving treatment to serve as a control (no     intervention).   "
127788|NCT01612416|"     The aim of this study is to examine whether there is a difference in macular ganglion cell     complex thickness and retinal nerve fiber layer thickness in early-stage Primary open angle     glaucoma and normal tension glaucoma with spectral domain OCT.   "
127789|NCT01612403|"     There are several causes leading to male infertility, like oxidative stress, and nutritional     deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three     types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands     (LMW). The present study was conducted to study the effect of Zn supplementation on the     quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels     in semen of patients with asthenozoospmia.   "
127790|NCT01612390|"     Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third     and fourth stages of labor   "
127791|NCT01612377|"     This study will compare an experimental drug called Z102 (combination of prednisolone and     dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe     Rheumatoid Arthritis for a period of 52 weeks.   "
127792|NCT01612364|"     This is a double-blind randomized controlled trial to evaluate the efficacy of the     sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients     with CRPS I refractory to medical treatment will be subjected to four physical therapy     sessions and then the randomized for experimental or control block and then more four     physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary     outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain     inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and     WHOQOL-brief).   "
127793|NCT01612351|"     The purpose of this study is to see if a three method risk adapted design using induction     chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make     treatment of squamous cell carcinoma of the head and neck (SCCHN) better.   "
127803|NCT01612221|"     This is a phase II intervention to propose a new melanoma chemoprevention agent. The     investigators believe oxidative stress/damage in nevi is a probable indication for melanoma     risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi     from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate     whether administration of NAC around the time of UV exposure will reduce melanoma risk in     high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and     2) examine key genetic variants that will identify which individuals are most likely to     benefit from chemoprotection.   "
127794|NCT01612338|"     The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan     Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) are conducting     a multidisciplinary academic/practice three-year project to increase appropriate breast     cancer screening for young breast cancer survivors and their cancer-free, female relatives at     greatest risk for breast cancer. The aims of this project are to: 1) identify and survey 3000     breast cancer survivors reported to the Michigan Cancer Surveillance Program who were     diagnosed between the ages of 20-45 years regarding their breast cancer screening     utilization; 2) identify and survey the survivors' female relatives regarding their breast     cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored)     of an evidence-based intervention recommended by the Guide to Community Preventive Services     to increase breast cancer screening. A follow-up survey will assess the effectiveness of each     intervention on a) breast cancer screening utilization; b) perceived barriers and     facilitators to screening; c) self-efficacy in utilizing screening services; d) family     support related to screening; e) knowledge of the genetics of breast cancer and personal risk     factors; and f) satisfaction with the intervention.   "
127795|NCT01612325|"     Radioembolisation is a known method for the treatment of liver tumors and or livermetastases.     Currently small beadlets called microspheres are used that are loaded with the beta radiation     emitting Yttrium-90. Holmium-166 microspheres have different physical characteristics     including good visualisation in gammacameras due to the gamma emission. Because of the higher     specific activity higher radiation doses to the liver will be used compared to the standard     Yttrium treatment. It is hypothesized that higher doses of irradiation have an improved     antitumor effect.   "
127796|NCT01612312|"     Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is     recommended by current guidelines, there are insufficient data to unequivocally support     thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus     containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is     a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The     hypothesis is that under the background of early revascularization, adjunctive thrombectomy     in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less     microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in     patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two     treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary endpoints     include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well     as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and     myocardial blush grade. Furthermore, clinical endpoints including death, myocardial     reinfarction, target vessel revascularization and new congestive heart failure will be     recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In summary, the     TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve     myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit     vessel reperfused by early PCI.   "
127797|NCT01612299|"     Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression     therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and at     6, and 12 months in renal transplantation patients. B. To investigate progression of CAC in     patients undergoing renal transplantation within the study period.      Secondary objectives:        1. To evaluate in renal transplantation the effect of Zortress® versus standard          immunosuppression therapy on bone mass as evidenced by changes in quantitative computed          tomography (QCT) and dual energy X-ray absorptiometry (DXA).        2. To evaluate in renal transplantation the effect of Zortress® versus standard          immunosuppression therapy on activity of bone forming and resorbing cells as evidenced          by changes in bone histology.        3. To evaluate in renal transplantation the effect of Zortress® versus standard          immunosuppression therapy on biochemical parameters of bone turnover as evidenced by          changes in serum Parathyroid Hormone (PTH), Bone-Specific Alkaline Phosphatase (BSAP),          Tartrate-Resistant Acid Phosphatase (TRAP), Sclerostin, Receptor Activator of Nuclear          factor Kappa B Ligand (RANKL), Osteoprotegerin (OPG), , serum CTX (C-terminal          telopeptide of type 1 collagen), and urinary NTX (N-terminal cross link telopeptide).        4. To evaluate in renal transplantation the effect of Zortress® versus standard          immunosuppression therapy on cardiovascular events, graft rejection and patient          survival.   "
127798|NCT01612286|"     The investigators designed this study to evaluate the efficiency and the acute toxicities of     recombinant human endostatin (endostar) combined with chemotherapy in the metastatic     nasopharyngeal carcinoma (NPC).   "
127799|NCT01612273|"     To explore the efficacy of triflusal in patients with symptomatic peripheral microcirculation     dysfunction. Triflusal is a salicylate compound approved in several countries as     antithrombotic agent and it additionally has vasodilatory effect. The hypothesis is to     explore if there is a improvement of peripheral microcirculation by triflusal.   "
127800|NCT01612260|"     The purpose of this study is to assess the effects of Chinese medicine Shensong Yangxin     capsule for the chronic cardiac dysfunction complicated with ventricular premature beats.   "
127801|NCT01612247|"     Patients with stage II-III breast cancer who do not achieve a pathologic complete response to     neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous     cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and     radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints     of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design     tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less,     against an alternative hypothesis (HA) event rate of 25% or more.   "
127802|NCT01612234|"     High intakes of saturated fat are associated with diabetes. Our work has shown that the two     most common fatty acids in the North American diet, palmitic acid (saturated fat) and oleic     acid (monounsaturated fat) are metabolized differently and have opposite effects on fat     burning. The proposed study will examine biochemical and molecular mechanisms for how a high     saturated fat diet versus a low saturated fat/high monounsaturated fat diet alters the action     of the hormone, insulin, in skeletal muscle.   "
127804|NCT01612208|"     The objective of this study is to document callus formation and healing of fractures     stabilized with locking plates utilizing modern MotionLoc screws that provide controlled     axial micro-motion to actively promote fracture healing.   "
127805|NCT01612195|"     Anal abscess-fistula disease is of common occurrence and has a significant impact on the     quality of life of affected individuals. The course of abscess-fistula disease as well as its     treatment modalities may affect anal continence. The present cohort study investigates the     results of anal fistula plug surgery. In particular, this study focus on the impact of anal     fistula plug surgery on fistula healing, quality of life, and anal continence. Fifty patients     will be included and followed up at 6 weeks and 6 months after surgery in the clinic of     participating surgeons.   "
127806|NCT01612182|"     The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement     therapy.   "
127831|NCT01611857|"     This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with     advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in     Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is     hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this     regimen.   "
127807|NCT01612169|"     Primary Objective: This study will evaluate the most effective strategy in achieving HIV     virologic suppression among HIV-infected substance users recruited from the hospital setting     who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2)     Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU).      Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of <= 200 copies/mL)     relative to non-suppression or all-cause mortality in the 3 study groups will differ from     each other at the 12 month follow-up.      Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of <= 200     copies/mL) in the PN+CM group will be greater than that in the TAU group.      Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than     that in the PN group.      Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than that     in the TAU group.      Secondary Objectives:        1. To evaluate the effect of the experimental interventions on: HIV virological suppression          and CD4 T-cell count changes at 6 months post-randomization; engagement in HIV primary          care and visit attendance; and rate of hospitalizations.        2. To evaluate the effect of the experimental interventions on: drug use frequency and          severity; and drug use treatment engagement and session attendance.        3. To assess selected mechanisms of action of the intervention (.i.e. mediators of          intervention effect).        4. To assess potential characteristics associated with differential treatment effectiveness          (i.e. moderators of intervention effect).        5. To evaluate the incremental cost and cost-effectiveness of the interventions.   "
127808|NCT01612156|"     The purpose of this study is to determine a difference in patient reported pain levels     before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel     or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when     compared to lubricant gel.   "
127809|NCT01612143|"     This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess     the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule     formulation in healthy volunteers. Subjects will be randomized to one of four treatment     sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule     formulation with or without a high fat meal, with a washout period of at least 14 days     between treatments.   "
127810|NCT01612130|"     The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg     in single oral doses one hour preoperative as conscious sedation during the impacted lower     third molar surgery.   "
127811|NCT01612117|"     Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine     (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular,     uNGAL has been used for early detection of AKI in the emergency department, after     cardiopulmonary bypass or following CM administration.      This study will be conducted to assess the possible value of urinary Neutrophil     Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy     (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP)     and whether or not uNGAL correlates with the volume of contrast medium (CM) used.   "
127812|NCT01612104|"     The purpose of this pilot-study is to evaluate a cognitive behavioral method Psychological     First Aid used with a group of children (11-16 years) in high risk of developing     psychological problems. Participants are recruited from a low-threshold program (The     Children's House in Oslo) where counseling is given to children suspected of being     physically or sexually abused, or having witnessed domestic violence. The study includes     twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological     problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed     at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be     assessed daily.   "
127813|NCT01612091|"     The Mobile Messenger is a unified, portable and intelligent device that integrates     information from multiple patient monitors, mechanical ventilators, infusion pumps and     clinical information systems on a mobile platform. It will allow nurses, respiratory     therapists and physicians to continuously monitor and coordinate care of critically ill     patients. This study will use a participatory design process to guide the design of an     integrated mobile device. Next, we will evaluate the proposed device in a simulated ICU     setting.   "
127814|NCT01612078|"     Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday     activities in hemodialysis patients. Since information regarding the use of droxidopa in     clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is     limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of     droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.   "
127815|NCT01612065|"     Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal     route is the best, optimum dose not yet known.   "
127826|NCT01611922|"     The purpose of this study is to assess eyelid margin staining, termed lid wiper     epitheliopathy (LWE), in three populations. The hypothesis is LWE will be more prevalent in     symptomatic contact lens wearers than non-symptomatic contact lens wearers and least     prevalent in asymptomatic non-contact lens wearers.   "
127890|NCT01611090|"     The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in     combination with bendamustine and rituximab in patients with relapsed or refractory chronic     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).   "
127816|NCT01612052|"     The current recommended antibiotic, Cefazolin, treatment for vascular surgery, provides     coverage only for Methicillin-Sensitive Staphylococcus Aureaus (MSSA), other gram-positive     bacteria, and some gram-negative bacteria which may not be adequate antibiotic treatment at     the time of vascular surgery and result in an increased hospital length of stay, increased     cost of care, and an increased risk of morbidity and mortality as a consequence of surgical     site infections. Thus, the investigators want to compare whether Methicillin-resistant     Staphylococcus Aureaus (MRSA) antibiotic prophylaxis with Cefazolin plus Daptomycin is     superior to Cefazolin plus Vancomycin in the reduction of surgical site infection (SSI)     following open arterial revascularization procedures requiring a groin plus lower extremity     incision. The investigators hypothesis is that Cefazolin plus Daptomycin is superior to     Cefazolin plus Vancomycin in the prevention of SSI for high risk patients undergoing open     groin plus lower extremity procedures.   "
127817|NCT01612039|"     This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study.     Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be     randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000     mg/d) or matching placebo in a 1:1 ratio for 8 weeks.      The study hypothesis is that treatment with ASP3291 compared to placebo will improve a     patient's ulcerative colitis endoscopic score from baseline to Week 8.   "
129794|NCT01586208|"     Identify the most effective dose of valproic acid when used in combination with phenytoin for     treatment of patients with refractory status epilepticus, which allow a better clinical     course and prognosis of the disease.   "
127819|NCT01612013|"     Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal     insufficiency and is associated with prolonged hospitalization and unfavorable early and late     outcomes. The investigators sought to compare 4 different strategies (intravenous high-dose     of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the     prevention of contrast-induced acute kidney injury in patients undergoing coronary     angiography using high-osmolar contrast media defined by creatinine and cystatin C serum     levels.   "
127820|NCT01612000|"     The purpose of this study is to investigate the safety and immunogenicity of a recombinant     hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at     3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA     formulation.   "
127821|NCT01611987|"     Despite the benefits of exercise and physical activity people with Multiple Sclerosis (MS)     are relatively inactive. Physical activity is important for persons with disabilities to     maintain physical function. A lack of physical activity can contribute to heart disease,     osteoporosis, obesity, and diabetes. At the moment, the best way for people with MS to     exercise and be physical activity is unknown. People with MS report not knowing what to do.     This is a barrier to exercise.      The global aim of this study is to contribute evidence for the role of targeted exercise in     altering MS outcomes over time. The design is a randomized controlled trial (RCT). The     primary research question is to what extent does an MS Tailored Exercise Program (MSTEP)     result in greater improvements in exercise capacity and related outcomes in comparison to a     program based on general guidelines for exercise among people with MS who are sedentary and     wish to engage in exercise as part of MS self-management. The primary outcome for this     question is exercise capacity measured using cycle ergometry. However exercise efficiency,     functional ambulation, strength, components of quality of life including frequency and     intensity of fatigue symptoms, mood, global physical function, health perception, and illness     intrusiveness, will also be measured as components of a global response outcome. The first     confirmatory hypothesis is that MSTEP will result in a greater proportion of people making     clinically relevant gains (at least 10% change) in exercise capacity than with general     guidelines after 12 months of intervention; a secondary hypothesis is that, while there may     be some decline in exercise capacity among individuals from end of intervention to follow-up     one year later, the decline will be greater in the general guideline group augmenting the     difference between groups in the proportion making 10% change from study entry to 24 months.     In other words, gains will be maintained more for the MSTEP group over the general guideline     group.      An exploratory hypothesis is that more of the targeted outcomes will improve with the MSTEP     program than the general guideline approach. An explanatory hypothesis is that these gains     will be accompanied by reports of greater exercise enjoyment and exercise self-efficacy     (confidence) with the MSTEP program than with the general guideline program leading to more     consistent exercise engagement and improved long-term adherence.   "
127822|NCT01611974|"     This study will assess safety, antiviral activity, and pharmacokinetics of different doses of     maribavir administered orally for up to 24 weeks for treatment of CMV infections that are     resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in     recipients of stem cell or solid organ transplants.   "
127823|NCT01611961|"     Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel     developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was     evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients     with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects     of DT-LM compared to commerical docetaxel.   "
127824|NCT01611948|"     Cannabis is the most widely used illicit drug in the United States, and worldwide, with 1 in     10 users estimated to meet diagnostic criteria for cannabis dependence. Avoidance of     withdrawal symptoms (e.g., disturbances in mood, sleep, and craving) is a common relapse     precipitant. Cannabis use also impairs executive cognitive functions thereby increasing     vulnerability to relapse and reducing the ability to benefit from behavioral therapy. There     are no pharmacological treatments for cannabis dependence, despite the large number of     afflicted individuals and the limitations of behavioral therapies which do not remediate     withdrawal and are associated with high rates of treatment failure. The primary aim of this     clinical trial is to evaluate the efficacy and safety of a novel neurokinin1 (NK1) receptor     antagonist, aprepitant (Emend), (125mg/day), in outpatients with current cannabis dependence.     The main hypothesis to be tested is to evaluate the relative efficacy of aprepitant 125 mg/d     vs. placebo for reducing cannabis withdrawal symptoms in cannabis dependent outpatients,     specifically anxiety, mood, craving and sleep.   "
127825|NCT01611935|"     Trauma patients, who are transfused with multiple blood products to treat shock due to blood     loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone     necessary to maintain an adequate blood pressure and low levels have been associated with the     need for increased transfusions, vasopressors and additional morbidity. Vasopressin is     routinely used in the ICU to treat septic shock and other disease processes resulting in     decreased vasopressin levels and low blood pressure. This study will investigate the     potential benefit of early vasopressin supplementation during the resuscitation of trauma     patients and the applicability of using copeptin as a vasopressin biomarker. Trauma patients     who receive 6 or more units of blood product within 12 hours of arrival will be randomized to     receive a vasopressin bolus plus infusion or a similar volume of a placebo (normal saline)     for 48 hours. Serial blood samples will be taken for 5 days post-injury. Clinical and     demographic data will be recorded prospectively.   "
127827|NCT01611909|"     This study aims to investigate the efficacy and safety of topical p-menthane-3,8-diol     (PMD)-rich Corymbia Citriodora oil (Citriodiol®) in children with impetigo. Citriodiol® is     already known to be effective as an insect repellent and is safe in its topical application.     The investigators have also found in our laboratory that it is bactericidal against     Staphylococcus aureus, the bacteria responsible for causing impetigo. Parents are always     searching for a natural alternative to antibiotics (the current gold standard treatment for     impetigo), and the investigators believe Citriodiol® could provide this possible alternative.   "
127828|NCT01611896|"     The purpose of this study is to investigate if selenium supplementation to the standard     treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a     fewer people with anti-thyroid treatment failure and faster remission, in terms of better     quality of life during the first year of treatment and more patients staying in remission.   "
127829|NCT01611883|"     This study will examine the effect of ezetimibe on glucose metabolism in participants with     Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated     hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the     placebo control group.   "
127830|NCT01611870|"     The purpose of this study is to evaluate the performance of AVAPS AE therapy in COPD patients     during nocturnal ventilation.   "
127832|NCT01611844|"     The only test available for in vivo diagnosis of tuberculosis is the intradermal injection of     tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin     test).      The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However,     this test needs to be performed by trained personnel, presents problem of reproducibility,     and its interpretation is not well standardized (measure in millimeters of skin induration 48     to 72 hours after the PPD skin test).      The new generation BD micro needle used in this study should solve the technical     difficulties; intradermal administration of tuberculin could then be made by any personnel.      A non-invasive and objective instrumental method of reading the test will be also tested .   "
127833|NCT01611831|"     The main objective is to assess the efficacy of Acceptance & Commitment Therapy (ACT) in     group for the treatment of fibromyalgia. The secondary aims are: 1.- To assess the     cost-effectiveness of ACT and 2.- To assess the efficacy of ACT in other variables such as     anxiety, depression, pain or global function. 3.- To evaluate the usefulness or     electroencephalographic cordance as a prognostic variable of the treatment.      HYPOTHESIS: ACT in group is effective for improvement of pain acceptance and other outcome     variables (pain, anxiety, depression, global function) in fibromyalgia, and it is     cost-effective. Cordance is an useful predictor of treatment efficacy in these patients.      DESIGN: Multicentre, randomized, controlled study, with parallel groups, and a 6-month     follow-up period. Participants will be randomly allocated to one of two conditions: 1.- Group     Acceptation & Commitment Therapy or 2.- Treatment as usual by his general practitioner.     Patients diagnosed of fibromyalgia, according to the American College of Rheumatology, will     be recruited in primary care. Assuming an alpha=0.05 and p=80%, using two tails, and     calculating 5% of refusals, it will be necessary a sample size of 55 patients for each group     of patients.   "
127834|NCT01611818|"     BACKGROUND: Major depression will become the second most important cause of disability in     2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective     option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided     psychotherapy have been carried out.      AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major     depression in the Spanish health system.      METHODS: The study is made up of 3 phases: 1.- Development of a computerised     cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter     controlled, randomized study: A sample (N=450 patients) with mild/moderate depression     recruited in primary care. They should have internet availability at home, not receive any     previous psychological treatment, and not suffer from any other severe somatic or     psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity     Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided     Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI     psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be     also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume     of health and social services). Patients will be assessed at baseline, 3 and 12 months. An     intention to treat and a per protocol analysis will be performed.   "
127835|NCT01611805|"     This is an double-blind, single dose, four-period, crossover study in Japanese healthy male     volunteers to assess the pharmacokinetics and safety/tolerability of single doses of     GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg     GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose     ascending crossover design. Serial pharmacokinetic samples will be collected following each     dose and safety assessments will be performed. The pharmacokinetics and dose proportionality     of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and     1000 mg under fasted conditions will be assessed. In addition, a comparison will be made     between the pharmacokinetics of GSK1605786 under fed and fasted conditions.   "
127836|NCT01611792|"     Low back pain affects 80% of Americans at some time during their lives. Although recovery     usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long     been thought that poor control of trunk muscle may lead to abnormal forces across the spine,     which then damage local spinal structures, thus, leading to low back pain. However, the     investigators know little about the function of specific trunk muscles in healthy subjects     during various activities of daily life. Furthermore, the precise muscle dysfunction     associated with low back pain has not been well characterized at all. In addition, the     investigators know little about which exercise protocol is most beneficial for particular     subgroups of people with low back pain. Thus, the purposes of this study are to learn more     about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most     beneficial for people with certain kinds of low back pain; and 3) how these exercises     influence trunk muscle function. By having a better understanding of which trunk muscles are     affected by low back pain, rehabilitation specialists can design exercise programs and     therapeutic interventions that are more specific and more effective.   "
127840|NCT01611740|"     Hospital-acquired infections are common complications in preterm infants. The diagnosis has     to be fast and accurate. Indeed, the early identification of a suspected infection is very     important, since the early administration of antibiotics lowers the risk of septic shock and     improves long term outcome in the infected newborns who survive. Besides, a high specificity     in the diagnosis of infection allows for the reduction of inappropriate treatment and thus     prevents the emergence of antibiotic resistance.      The aim of this study is to develop a computer-assisted diagnosis tool, based on the real     time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of     infection of the preterm infant, at the bedside.   "
127876|NCT01611272|"     To identify the following items through the post marketing surveillance under routine     clinical practice after marketing authorization of Brilinta Tablet: the occurrence of     unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events     (AEs), the factors that may influence safety and efficacy of the drug.   "
127841|NCT01611727|"     Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical     issue. There are emerging data which suggest that mutation carriers may respond differently     than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary     cancers for a range of pathologic and molecular factors, including tumor grade and histologic     appearance. Several studies have shown that the response to treatment for women with a     BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the     impairment of the DNA damage response and repair pathways, and that it is possible to exploit     the sensitivity of BRCA1-associated cancers to DNA damage.      It is equally important that the investigators evaluate the benefit of cisplatin in women     with disseminated breast cancer, including those who have previously been treated with one or     more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin     chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to     determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast     cancer. The secondary objectives are to determine 3-year survival and to evaluate the     toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.   "
127842|NCT01611714|"     This study will 1) Develop two interventions: a) an audit-feedback email intervention that     provides clinicians with data on CT scan ordering practices by patient race; and b) a     clinical decision support (CDS) message in the electronic medical record headache template;     and 2) Compare the effectiveness of these 2 interventions in eliminating a previously     observed Black-White disparity in CT scanning rates to rule out subarachnoid hemorrhage     (SAH).   "
127843|NCT01611701|"     The aim of this prospective randomized double-blind study was to compare the efficacy and     safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after     failed first radiofrequency ablation.   "
127844|NCT01611688|"     This trial is conducted in Europe. The aim of this trial is to describe the safety and     tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in     subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.   "
127845|NCT01611675|"     This research study was intended to be a Phase I/II clinical trial, but the trial was     terminated before the phase 1 portion was completed. Phase I clinical trials test the safety     of an investigational combination of drugs. Phase I studies also try to define the     appropriate dose of the investigational drug combination to use for the Phase II portion of     the study, which will enroll more participants and continue to study the effects of the drug     and the safest dose. Investigational means that the combination of vemurafenib and     leflunomide is still being studied and that research doctors are trying to find out more     about it. It also means that the FDA has not approved this drug combination for your type of     cancer.      Genes are a specific part of your cell materials which send code messages to determine what     the investigators bodies look like, such as eye color, and instruct cells to control growth     and development of the body. Researchers have found that a large number of melanoma cells     have mutations in the BRAF gene. Normally, the BRAF gene helps to control how cells grow.     Mutations in the BRAF gene may disrupt this control and allow cells in the skin to change     into cancer cells, in which case, the cells keep dividing and growing out of control.     Specifically, it has been shown that vemurafenib blocks the effects of these mutations in the     BRAF gene, and, as a result, may help to prevent cancer growth. The FDA has approved     vemurafenib for use in patients with BRAF mutation positive melanoma that is unable to be     removed by surgery (unresectable) or that has spread (metastatic).      Leflunomide is in a class of medications called disease-modifying antirheumatic drugs     (DMARDs). It is FDA approved for the treatment of rheumatoid arthritis and it is believed to     decrease inflammation in that setting. However it is not approved for treatment of melanoma.     The researchers of this study believe this agent may help prevent cancer growth as well as     enhance the properties of drugs that target the BRAF gene (such as vemurafenib) based on     recently published laboratory research, and would like to learn more about any effects this     combination may have on your disease.      The main purposes of this study are to determine the highest dose of vemurafenib and     leflunomide that can be given in combination without causing severe side effects, to see     whether the combination of vemurafenib and leflunomide is safe in participants with BRAF     mutant metastatic melanoma and to learn if the combination of vemurafenib and leflunomide     shows any signs of effectively treating your disease.   "
127846|NCT01611662|"     The purpose of this research study is to find out what effects, good and/or bad, dose-dense     (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given     before surgery have on patients and their muscle invasive bladder cancer.   "
127847|NCT01611649|"     The objective of this study is to determine whether the use of a mix of dairy lipids and     plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane     phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula     containing only lipids of plant origin.   "
127848|NCT01611636|"     The incidence and prevalence of the allergic, autoimmune and rheumatic diseases are different     all over the world. The relative impact of gene and environment on diseases can be revealed     by studies from different populations. National Health Insurance database in Taiwan provides     a wealth of epidemiology study, which can contribute to the understanding of these diseases.     However, national health care database did not contain test results and clinical details. The     database of the hospital records can provide complimentary clinical details. Via the     comparison of databases of the National health Institutes and the investigators hospital, the     investigators hope that the characteristics and outcomes of these patients can be better     understood.   "
127849|NCT01611623|"     Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an     experimental drug that blocks Hsp90. It is being evaluated for safety in patients with     cancer.   "
127850|NCT01611610|"     The aim of this project is to establish a network of clinical teams including the major     neuromuscular centers in Europe.      We plan to work together to find the best common outcome measures for the following     multicenter therapeutic trials.   "
127851|NCT01611597|"     Validation of a measure specifically suitable to evaluate the residual function of upper     limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy and     spinal muscular atrophy.      This approach is of fundamental importance for clinical monitoring and preparing the future     therapeutic trials.   "
127861|NCT01611467|"     Part 1: To characterize the biotransformation and excretion of CC-223 following a single     20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in     healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral     dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male     adult subjects Part 2: To evaluate the effect of a high-fat meal on the pharmacokinetics (PK)     of CC-223 following a single 20-mg oral dose of CC-223 tablet; To evaluate the effect of a     high-fat meal on the PK of M1, the principal pharmacologically-active metabolite, following a     single 20-mg oral dose of CC-223 tablet; and to evaluate the tolerability of CC-223 after a     single 20-mg oral dose of CC-223 tablet in healthy male adult subjects.   "
127862|NCT01611454|"     The PREFER II trial primary objective of the trial is to show how much radiation attenuation     is provided by XPF thyroid collars in absolute and relative terms.   "
127853|NCT01611571|"     The purpose of this study is to develop new treatment options for osteoporosis in men. The     Investigators will study two medications and three treatment regimens. First, risedronate     (FDA approved) will be studied as monotherapy. Second, the investigators will study     injectable parathyroid hormone (PTH 134, teriparatide; FDA approved), as a therapy for male     osteoporosis. PTH, a naturally occurring hormone produced by the parathyroid glands, is one     of the most important regulators of bone metabolism. The drug being studied in this protocol,     teriparatide, is the first aminoterminal 34 amino acids of the native 84amino acid peptide.     Teriparatide contains all of the classical biological activities of native PTH. In studies of     postmenopausal women, in a small study of 23 men with osteoporosis and a larger study of 437     men treatment with teriparatide led to significant increases in bone density. Although     teriparatide and actonel are now approved for osteoporosis in men additional studies of these     medications are needed in order to establish how best to use these drugs. This study is     focused on an entirely new treatment approach, namely the combination of two medications for     the treatment of osteoporosis risedronate with teriparatide to evaluate whether combination     therapy is superior to therapy with either medication alone. This study is also designed to     assess the extent to which risedronate maintains increases in bone density after a course of     mono or combination therapy.   "
127854|NCT01611558|"     To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall     response associated with ipilimumab treatment   "
127855|NCT01611545|"     The aim of this biospecimen repository is to evaluate an individual's genotype, identify the     variances, and understand how they relate to treatment with clopidogrel.   "
127856|NCT01611532|"     Acute pancreatitis is a multi-system disease with an unpredictable clinical course and     significant morbidity and mortality Approximately 20% of patients develop multi-organ failure     requiring management within a critical care environment However much of the pathophysiology     of the disease, particularly understanding why some patients develop life-threatening disease     whilst others have a relatively benign course, remains unclear.      It well recognised that intra-abdominal hypertension (IAH) is a cause for organ dysfunction     in critically ill patients and is associated with higher morbidity and mortality rates     (Sugrue et al., 1999). Abdominal compartment syndrome (defined as an increase in     intra-abdominal pressure (IAP) >20mmHg) is associated with new organ failure (Malbrain et     al., 2006). The mechanisms believed to contribute to IAH in acute pancreatitis include     increased capillary permeability, hypoalbuminaemia and volume overload (third space     losses), producing retroperitoneal and visceral oedema (Dambrauskas et al., 2009).      Several small studies have recently described the link between intra-abdominal hypertension     and adverse outcome in acute pancreatitis ( Dambrauskas et al., 2009; de Waele et al., 2005),     however none of the authors appreciate the potential predictive value of there conclusions or     the potential as a target for therapeutic intervention to alter the disease course.      This study aims to study the natural history of intra-abdominal pressures in acute     pancreatitis and determine whether they truly do have a predictive value or whether they are     simply another marker of organ failure in a multi-system disease with notoriously poor     outcome.   "
127857|NCT01611519|"     Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery     with an epidural catheter in place?   "
127858|NCT01611506|"     RATIONALE: Radiotherapy is currently the most efficient way to induce pathologic responses,     which are associated with a favorable prognosis in localized tumors. Novel radiotherapy     techniques are associated with significantly less toxicity than traditional radiation     protocols and permit to avoid the toxicity to adjacent organs. Established chemotherapy     regimens, such as cisplatin and capecitabine, and monoclonal antibodies, such as cetuximab,     can block tumor growth in different ways. Giving radiation therapy together with cisplatin     and cetuximab before surgery aims to induce a pathological response and improve the prognosis     after surgery.      PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy     when given together with cisplatin and cetuximab in treating patients who are undergoing     surgery for locally advanced gastric cancer.   "
127871|NCT01611337|"     Therapeutic alliance, and drug observance are major difficulties in the care of persons     presenting schizophrenic symptomatology. They appear to be linked to insight, the     consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it,     but usually without using specific evaluation tool. Insight is usually not evaluated during     care, and its evolution is also not known, although it is highly probable that a positive     evolution of insight for a person in hospital correlated to an adapted and optimal care by     the medical and nursing teams. The investigators do not know examples of insight evaluation     during a sequence of hospital care, or any evidence of insight variation in relation to     evolution abilities of some schizophrenic patients cared in hospital.      The investigators propose here to evaluate insight in people presenting schizophrenia or     related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better     characterize insight variations, and identify the sociodemographic, clinical and therapeutic     variables linked to it.   "
127872|NCT01611324|"     The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2%     mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local     infiltration anesthesia, during ambulatory phlebectomy procedures.   "
130161|NCT01581320|"     A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to     evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the     improvement of vitamin D in postmenopausal women with osteoporosis.   "
127859|NCT01611493|"     A potential complicating factor affecting implants is crestal bone loss. The causes of     crestal bone loss are attributed to several factors. Among those hypothesized, proof for one     or another cause remains obscure. Clinical documentation suggests that implant design may be     a key factor. While the evidence is inconclusive, various authors suggest that it is a result     of a combination of effects including (1) limited drilling procedure and restricted     second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design     for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the     absence of a significant microgap 6.      The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant     seating surface physically moves the inflammatory cell infiltrate zone away from the crestal     bone). The growing body of anecdotal platform switch evidence supports this biological width     hypothesis. Here the biological width refers to the height of the dento-gingival attachment     apparatus around a normal tooth and is defined as the distance necessary for a healthy     existence of bone and soft tissue from the most apical extent of a dental restoration.      To formally test this hypothesis the current study has been designed. The Prevail implant has     been made with an integrated medialized seating surface that establishes a platform switching     function. This implant moves the implant/abutment interface away from the crestal bone and     may therefore reduce the amount of bone loss observed in the standard (non-medialized)     Osseotite implant design. The objective of this study is to evaluate crestal bone levels     adjacent to the implant reference point from the time of implant placement to a period of two     years after loading.   "
127860|NCT01611480|"     The aim is to evaluate efficacy and safety of three different dosing regimens of Limtop in a     study involving 96 patients with actinic keratosis on the head or face.   "
127863|NCT01611441|"     The main purpose of the study is to better understand how specific proteins/markers in blood,     urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and     joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there     is a correlation between x-ray results, specific proteins/markers and different types of pain     in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days     and the last visit will be the day of surgery.   "
127864|NCT01611428|"     A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.   "
127866|NCT01611402|"     Background:      - Tuberculosis (TB) infection is particularly deadly when it happens in people who are also     infected with the human immunodeficiency virus (HIV). However, not much is known about how     these two infections affect each other. Some people who have HIV or TB infections develop     health problems after they start taking either HIV or TB medications or both. These drugs can     improve the body s ability to fight infections, but sometimes this sudden improvement can     make the infected person initially become sicker. Researchers want to study how these     infections affect the immune system and the gene expression of people who have TB and may or     may not have HIV, to see if there is a pattern of gene expression that may predict whether     people starting treatment may get sicker initially.      Objectives:      - To study the gene expression and immune systems of people with TB who may or may not also     have HIV.      Eligibility:        -  Adults at least 18 years of age who have tuberculosis.        -  Participants will be drawn from study sites in the United States and China.      Design:        -  Participants will be divided into three study groups. The first group will have TB but          not HIV. The second group will have both TB and HIV that have not been treated. The          third group will have both TB and HIV that are currently being treated.        -  All participants will have a single study visit. Blood samples will be collected at this          visit. A medical history will also be collected.        -  No treatment will be provided as part of this study.   "
127867|NCT01611389|"     The aim of this study is to evaluate the effect of minimizing right ventricular pacing in     dual-chamber pacemaker patients with sinus node disease (SND) and first degree     atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure     measures.   "
127868|NCT01611376|"     The investigators validated ICG's(impedance cardiography) usefulness during the abdominal     surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)   "
127869|NCT01611363|"     In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM     subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma     glucose in T2DM subjects will be investigated.   "
127870|NCT01611350|"     The purpose of this study is to determine the effectiveness of different sales offers and     different marketing messages to increase the uptake of energy efficient cookstoves.      This research will address the following major barriers to the acquisition and correct use of     improved cookstoves into four main categories:        -  Inappropriate product or marketing for intended users        -  Lack of consumer trust in new products        -  Failure to address consumers' financial constraints        -  Failure to achieve behavioral change      To do so this research includes 3 Randomized Controlled Trials including:RCT 1- Testing the     Effectiveness of Marketing Messages in Increasing Willingness to Pay; RCT 2- Testing the     Effectiveness of the Novel Sales Offer and its ability to Increase Uptake of Purchasing     Energy Efficient Cookstoves; and RCT 3-Measure the Effects of Fuel Efficient Cookstoves on     Health, Fuel Use and Time Spent Collecting Fuel.      RCT 1 studies the price women are willing to pay for the improved stove. It will also test     the effects of the two most effective marketing messages identified during the Phase 1     Feasibility stage (e.g., improved health, saves time, and has high status) on increasing     willingness to pay. RCT 1 will run second price auctions in 36 parishes with an average of 60     participants per meeting.      From RCT 1, RCT 2 tests the effect of a Novel Sales Offer- which includes a free trial, and     time payments- on purchasing decisions of participants versus those that receive the     Traditional Offer- a cash and carry offer. Based on a pilot in urban Kampala conducted by Dr.     David I. Levine (co-P.I. on this project) results show a 44% uptake for households offered     the novel offer vs. a 4% uptake for those offered the traditional offer. The hypothesis is a     novel offer will significantly increase uptake of fuel efficient cookstoves in rural Uganda     when compared to a traditional offer.      RCT 3 measures the impacts of fuel efficient cookstoves on health, fuel usage, and time spent     collecting fuel. For RCT 3 we will randomize those who accept the Novel Offer into early and     late groups. To measure the impacts of improved stoves on health, fuel use, time spent     collecting fuel, etc., there will be a baseline and follow-up survey and associated     quantitative measures on our full sample and a small endline on select quantitative measures     for a sub-sample.   "
127873|NCT01611311|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 409306 in healthy young and elderly male and female volunteers following oral     administration of repeated rising doses, given once daily over 14 days to young healthy     genotyped and elderly healthy male/female volunteers.   "
127924|NCT01610648|"     The study is being conducted to test the ability of a simple questionnaire to detect mild,     moderate or severe obstructive sleep apnea. The investigators are also investigating whether     adding the size of the neck and waist can add to the accuracy of the questionnaire.      The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The     investigators hope to enroll 250 patients in our study at Tufts Medical Center.   "
127874|NCT01611298|"     This research study is for subjects that are receiving a bone marrow transplant. As part of     the transplant subjects will receive stem cells from a donor who has agreed to donate stem     cells for them. Unfortunately, it takes a long time for the immune system to recover after a     bone marrow transplant. This makes it more likely for patients to develop serious infections.      This study is being done to better understand how the immune system will recover after     transplant. The immune system includes the cells that help fight infection. This study will     help investigators understand which patients are at risk for developing infections after     transplant.      All children and adults receive standard vaccines (shots) during their lifetime to provide     protection from many different infections. One such infection is tetanus, a bacteria that can     cause life-threatening problems. After transplant patients no longer have protection from     infections such as tetanus. Therefore, most patients need to receive all their vaccine     (shots) again after transplant. This is usually done 1-2 years after transplant, since it may     take that long for patients to have a normal immune system.      However, the investigators believe that the time it will take for the patient to develop     normal protection against tetanus can be shortened if both the patient and the patient's stem     cell donor receive a tetanus vaccine.      The goal of this study is to determine if giving a tetanus vaccine to the donor and the     patient will provide the patient with enough protection (immunity) to prevent infection     following bone marrow transplant.   "
127879|NCT01611233|"     DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a     higher than expected revision rate reported in the England/Wales and Australian national     joint registries. There are two types of ASR hip implants used for total hip replacement     surgery:        -  ASR XL Hip System        -  ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the          study sponsor. MGH is conducting this study with the help of funding from DePuy          Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects          around the world. The countries include the United States of America, Australia, South          Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test          results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will          analyze the data annually for 6 years.      The purpose of this study is to follow patients who have the ASR hip system for the next 6     years. The findings of this study may help surgeons to make better informed decisions about     monitoring and treatment of patients with ASR hip systems.   "
127880|NCT01611220|"     Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to     a healthy level, but high percentage of patients relapse during the first year following the     discharge. The development of strategies to overcome this problem represents a priority for     clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program     based on cognitive dissonance theory developed for hospitalized patients.   "
127881|NCT01611207|"     The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or     Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic     Subcutaneous Abdominal Wound healing-impairments (ISAW).   "
127882|NCT01611194|"     Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy     for persistent post-concussive symptoms after mild tramatic brain injury   "
127883|NCT01611181|"     Hemoboost is a registered natural product containing specially processed haemolysed     haemoglobin and iron dextran. It is marketed for human use on the basis of many years' use     and documented effect in veterinary medicine. Iron dextran was introduced for use in human     medicine in 1954.      Krauterblut is a registered natural product made from a number of herbs where the active     substance is ferrous gluconate. Both drugs have been available for a number of years and have     become increasingly popular among patients and healthcare staff due to a reduction in adverse     effects.      The objective of this study is to determine the effect and adverse effects of the natural     products Hemoboost and Kräuterblut compared with the usually administered ferrous sulphate in     knee arthroplasty.   "
127884|NCT01611168|"     The proposed research study aims to determine whether applying the University of Pittsburgh     Medical Center Nurse-Directed Diabetes Management Protocols (NDMPs) leads to improved     clinical outcome and process measures as recommended by American Diabetes Association (ADA),     quality of life, treatment satisfaction and medication adherence for adults with diabetes,     and favorable providers' satisfaction as compared to usual diabetes care. Furthermore, the     cost-effectiveness of performing the NDMPs compared to usual diabetes care in primary care     settings will also be assessed.   "
127885|NCT01611155|"     You are being asked to take part in this research study because you are going to be treated     with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes     neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the     effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on     oxaliplatin-induced neuropathy (numbing, tingling and/or pain)   "
127886|NCT01611142|"     The primary objective of this study is to determine the overall response rate of KW-0761 for     the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the     receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are     considered to play a role both in the recruitment of immune and inflammatory cells for     anti-tumor response and in the selective homing of neoplastic B and T cells.   "
127887|NCT01611129|"     The purpose of this study is to determine whether the use of 'patient journey' model in     internet-based counseling of a person with hearing impairment is a feasible approach in     management of emotional and social consequences, anxiety and depression, readiness to change     and acceptance of hearing loss.   "
127888|NCT01611116|"     Standard chemotherapy is capable of eliminating most leukemic blasts in acute myeloblastic     leukemia (AML), while leukemia-initiating cells are not sufficiently eradicated. As a     consequence, refractory disease and relapse frequently occur in AML, especially in elderly     patients. The investigators propose that the addition of temsirolimus may improve standard     AML chemotherapy. Furthermore, temsirolimus may specifically target the leukemia-initiating     cells in AML, thereby reducing the risk of leukemia relapse.      The study's main part is preceded by a open label run-in part, in which optimal temsirolimus     dose and schedule for the main part o the study will be determined.   "
127891|NCT01611077|"     The investigators want to find out if a treatment with a new combination of two different     antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately     elevated blood pressure is more effective than treatment with just one substance     (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve     comparable baseline conditions. Treatment is then started with the single substance. After     six weeks, therapy is changed to another single substance and after a further six weeks, to     the fixed combination tablet. Blood pressure is determined by office measurements taken by     the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be     male or female and must be over 18 years of age.   "
128538|NCT01602614|"     This is a clinical sampling study, and no study drugs will be administered under this     protocol. Premature infants who receive intravenous ganciclovir as part of clinical care will     be eligible for participation in this study. Intravenous ganciclovir will not be provided     under this protocol.   "
127892|NCT01611064|"     Hand surgery requires a reduced blood flow to the hand during the operation, which is     achieved using a tourniquet (tightly inflated circumferential cuff) around the upper arm.     However this tourniquet is painful. This study investigates whether breathing oxygen can     reduce the pain associated with the tourniquet to both improve patient experience and     potentially to allow longer operations to be completed under a local anaesthetic (rather than     a general anaesthetic, where the patient is put to sleep, which is more costly, time     consuming and risky for the patient).   "
127893|NCT01611051|"     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2     trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma     half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to     determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia     following chemotherapy in patients with breast cancer.   "
127894|NCT01611038|"     The primary objective of this study is to determine if vitamin supplementation with a     naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine)     can restore disruption of circadian rhythm in shift workers.   "
127895|NCT01611025|"     This is a retrospective, multicentre, observational study to assess the trends in antibiotic     utilization and hospital ecology with respect to susceptibility patterns of selected     bacterial isolates to the utilized antibiotics.   "
127896|NCT01611012|"     The purpose of this study is to determine the type and degree of inflammatory parameters in     peripheral blood of asthma patients compared to analysis of induced sputum.      115 asthma patients visiting the outpatient clinic of the University Medical Center will be     included. Blood samples are obtained and sputum induction is performed.      Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by     changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained     from induced sputum   "
127897|NCT01610999|"     In order to keep our immune systems healthy over our lifetime, certain cells in the bone     marrow and lymph nodes called stromal cells nurture the immune cells and protect them from     damage. Stromal cells and blood cells communicate using a protein called SDF1a. The     investigators think that cancer cells including lymphoma and multiple myeloma can trick the     stromal cells into helping them avoid damage from chemotherapy by using SDF1a.      Plerixafor is a drug developed to block the effects of SDF1a and has been approved by the     Federal Drug Administration (FDA) for use in humans to help release blood stem cells from the     bone marrow for use in transplantation. The use of plerixafor to interrupt communication     between stromal cells and cancer has not been approved by the FDA and is experimental.   "
127898|NCT01610986|"     The purpose of this study is to determine whether glucose-fructose intake during training     increases lactate transport and oxidation and improve endurance performance.   "
127899|NCT01610973|"     The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front     of the eye.      When the eye becomes opaque, the eye is not seeing and the only way to restore the visual     acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In     half the cases the opacification of the cornea is secondary to dysfunction of the     endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of     regulating the moisture of the corneal thickness and therefore its transparency.      While the total corneal transplantation has long been the only intervention for these     diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called     endothelial transplant or graft lamellar later. This intervention is now experiencing     significant success as it reduces very significantly the incidence of complications found     after transplantation of total cornea and the visual recovery period. This type of transplant     is still difficult to achieve and the best technique is not yet established.      Indeed, posterior lamellar transplantation of the cornea may be done manually or using an     automated device. Manual techniques allow the preparation of grafts extremely thin but are     difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may     be less efficient in visual recovery.      The aim of this project is to conduct a prospective study in order to compare these two     techniques in terms of postoperative visual recovery and the vitality of the graft during the     first year. To date, there is no such study.      The department of Ophthalmology in the University Hospital of Rouen is one of the most famous     French teams in the field of cornea transplants and receives many patients from different     French regions. The recruitment of 40 patients needed to study should be done without great     difficulty over a period of 18 months.   "
127900|NCT01610960|"     Noninvasive ventilation (NIV) is a well established, safe, and effective technique in     improving gas exchange while reducing dyspnea and inspiratory effort in patients with either     hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to     endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory failure,     are the tolerance to the interface used and the ability of the interface to unload     inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of     NIV for longer periods, while face mask has been proved to be more efficient at iso-support     in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT     (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better     compliant wall, that avoid the use of armpit braces potentially improving, compared to the     standard helmet, both pressurization and patient-ventilator interaction and tolerance. The     objective of this study is to compare the effects of NIV delivered via face mask, standard     helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and     comfort.   "
129183|NCT01594216|"     This is a Phase II investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in     combination with Exemestane in patients with estrogen-receptor positive advanced breast     cancer. The objective of this study is to determine the preliminary safety and efficacy of     the combination of exemestane and Ruxolitinib (INCB018424).   "
127901|NCT01610947|"     Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or     infliximab), and in stable low disease activity for at least 6 months, will be randomized     into 2 groups: either keeping on their usual treatment with stable doses or progressive     spacing of injections of their treatment. Follow-up will be done every 3 months during 12     months, with regular monitoring of disease activity and, in patients from the group     spacing, modification of the rhythm of injections according to health state and predefined     protocol.   "
127902|NCT01610934|"     The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in     patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.   "
127961|NCT01610154|"     1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon          release and improve glucose control in Chinese type 2 diabetic.        2. There are different effects of Sitagliptin therapy on blood glucose regulation,          pancreatic alpha & beta cell function are different in lean (BMI<25) and overweight          (BMI>25) Chinese type 2 diabetics.        3. The purpose of this study is to determine whether glucagon release may contribute over          30% to the hyperglycemia in Chinese type 2 diabetics.   "
127903|NCT01610921|"     Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial     tree including the small airways (<2mm). Since the introduction of the solution     hydrofluoroalkane (HFA) technology it is possible to generate medication with small particles     of approximately 1-2 μm, and therefore to reach the small airways. However, at this moment     the investigators have no reliable instruments to identify the asthmatic subjects who     particularly benefit from treatment with inhaled small particles. Recently the investigators     research group investigated whether provocation with small and large particles AMP is able to     identify responders and non-responders to treatment with small and large particles of inhaled     corticosteroids. This provocation technique gave promising results but needs further     optimization.      The aim of this study is to determine the optimal particle size of dry powder adenosine to     assess small airway involvement in asthma. Secondary, to provide insight in the associations     between the standard test, executed with nebulized AMP, and the new test, executed with dry     powder Adenosine.   "
127904|NCT01610908|"     The primary aim of this multicenter randomized controlled trial is to compare the effect of a     6 month Schroth exercise program combined with standard-of-care to standard-of-care alone     on scoliosis curve severity measured using the Cobb angle.      Secondary aims include:        1. To determine the effect of Schroth exercises at 6 months on secondary outcomes including          quality-of-life, spinal appearance, objective posture and spinal muscle endurance          measurements.        2. To determine the efficacy of 6 months of Schroth therapy offered to control participants          after completing 6 months in the standard-of care group (using subjects as their own          controls)        3. To determine if the effects of the 6 months supervised Schroth exercise program can be          maintained after supervised therapy is terminated.      At Hopital Ste-Justine, the following secondary aims will be pursued to examine the     preliminary evidence about the effect of Global Postural Re-education (to satisfy the local     ethics committee request because Global Postural Re-education exercises were offered     routinely to patients at that institution prior to the trial).      A. To compare the effect and to quantify the treatment effect sizes of 6 months of Global     Postural Re-education exercises with North American standard Care consisting of only     observation and bracing to Schroth exercises combined with North American standard care     and to North American standard care alone on scoliosis curve severity measured using the     Cobb angle.      B. To estimate the effect and quantify the treatment effect sizes of 6 months of Global     Postural Re-education exercises with North American standard Care to Schroth exercises     combined with North American standard care and to North American standard care alone on     outcomes including quality-of-life, perceived spinal appearance, objective posture and spinal     muscle endurance measurements.      C. To determine if the effects of Global Postural Re-education exercises with North American     standard Care can be maintained after discontinuing supervision.      D. To estimate the feasibility of conducting a randomized trial focused on Global Postural     Re-education exercises by quantifying enrollment rates, attendance at scheduled exercise     sessions and compliance with the home exercises prescribed.   "
127905|NCT01610895|"     The objective of the study is to examine the effect of adding a strict low-residue lunch on     the day before colonoscopy has on clinical efficacy and patient tolerability of bowel     preparation, with patients receiving split-dose Polyethylene Glycol Based Lavage.      The primary outcomes will be 1) quality of preparation in cleansing the colon and 2) patient     satisfaction   "
127906|NCT01610882|"     This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's     recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps     determine what medication they need. Traditionally, this involves asking the child to rate     their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to     one of a series of faces on a piece of card. The Panda uses the same methods, but presents     them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain     scores as the traditional methods.   "
127907|NCT01610869|"     The primary objective is to explore the efficacy and safety of an all oral combination of     BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in patients     with multiply-relapsed advanced ovarian cancer, who have completed a minimum of two lines of     previous chemotherapy and who for any reason are not suitable for further 'standard'     intravenous chemotherapy treatments.   "
127908|NCT01610856|"     Proper bowel cleansing prior is an essential requirement for the conduct of colonoscopy.     However, due to the nature of cleansing process, the ideal bowel cleansing preparation     remains elusive.      The objective of this study is to compare the efficacy, safety and tolerability of oral     polyethylene glycol lavage given either as a single dose or split dose. The study will be a     randomized controlled single blind two group study. The primary study outcomes will be the     previously validated Ottawa bowel preparation score.   "
127909|NCT01610843|"     The aim of this study is to collect information about the clinical course and characteristics     of sarcoidosis patients around the world through web-based surveys. Recruitment is directed     at and driven by patients in the sarcoidosis community. This will allow the the investigators     to study sarcoidosis patients across all demographic, geographic, and socioeconomic     boundaries, not just patients seen at large research centers. The investigators believe this     study can give investigators a broader and less biased view of sarcoidosis. The investigators     would also like to collect genetic samples on this population to assess genetic variance in     different phenotypes.      The information for the study would be provided through a web based survey system that can be     accessed by patients or physicians of patients from any computer with Internet access. This     system would collect clinical information in sufficient detail so that the phenotype of     individual patients can be evaluated. Upon agreeing to participate in further research     studies through the website, subjects will also have the opportunity to provide a DNA sample.   "
127925|NCT01610635|"     It is hypothesised that the number of donations made by English blood donors will be greater     with reduced vs. standard inter-donation intervals. The null hypothesis is that there will be     no difference in donations between treatment groups; this may arise if reduced inter-donation     intervals result in a greater number of donation deferrals (due to low haemoglobin) and/or an     unacceptable burden to donors.   "
127910|NCT01610830|"     Henoch Schonlein Purpura (HSP), vasculitis of small vessels with deposits of IgA, is     considered by many authors as the systemic form of Berger's disease (IgA-N). IgA-N is     characterized by IgA1 deposits in mesangial areas associated with mesangial proliferation.     These two diseases remain the leading cause of ESRD by primitive glomerulopathy in Western     countries. In recent years, considerable progress has been made in understanding the     pathophysiological mechanisms of IgA-N. However, only a high rate of proteinuria at one year     or the presence of severe glomerular inflammation on renal biopsy remain predictors of long     term renal function. Moreover, the high variability of HSP clinical expression, from few     purpura skin lesions that evolve favourably spontaneously, to rapidly progressive renal     failure, remains so far unexplained but suggests the existence of individual genetic     susceptibility.      In the first part of the study, we will study key factors based on physiopathological data     obtained by our laboratory as well as by other groups. The second part of the study concerns     genetic factors. Although the candidate genes that may confer a particular susceptibility to     the disease, to progress to ESRD or respond to treatment are many, the genes involved in     inflammation or controlling renin-angiotensin system are of particular interest.      We will apply these results by studying patients with HSP showing three distinct phenotypes     (HSP with isolated cutaneous purpura or associated with minimal or severe renal disease) at     diagnosis and after clinical remission.      The purpose of this study is to assess whether the phenotype at diagnosis is associated with     the physiological markers and if one of them predicts a pejorative evolution of renal disease     at 1 year. Meanwhile, study of polymorphism of selected genes of interest could allow     identification of patients with specific genetic susceptibility or with bad prognosis factors     who would be thus eligible for specific treatment.   "
127962|NCT01610141|"     The purpose of this study is to determine whether pharmacogenetic guided dosing of warfarin     is promising for the improvement of efficiency, therapeutic efficacy, and, especially, safety     of warfarin therapy than a dosing regimen without the pharmacogenetic information in Chinese     patients initiated on warfarin anticoagulation.   "
127911|NCT01610817|"     Adverse drug events (ADEs) are responsible for 3.6% of the hospitalisations in France. 50% of     these ADEs could be preventable. Cardiovascular drugs are frequently involved in ADEs. A     common underlying factor of such events is inadequate communication between patients and     medical personnel. General practitioners (GP) often initiate the treatment of hypertension,     being generally the first prescribers of these medications. 12.6% of the patients present an     ADE with hypertensive drug after 3 months. The InPAct procedure is a tool to facilitate     communication in order to improve patient safety in primary care. In the context of the     primary care prescription of an antihypertensive drug, the GP informs the patient about     hypertension, cardiovascular risk, and the benefits and risks of antihypertensive drugs,     which helps the patient to detect and declare situations involving a heightened risk of     antihypertensive-related ADEs. The aim of the InPAct study is to evaluate the efficiency of     the InPAct intervention in primary care.   "
127912|NCT01610804|"     The purpose of this study is to determine changes in choroidal thickness in patients with     Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis via     Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT).      Study hypothesis: Since exudative changes in the choroid seem to constitute the primary     pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present     and be visible using EDI-OCT.   "
127913|NCT01610791|"     This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra     (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an     inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive     RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6     infusions).   "
127914|NCT01610778|"     This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2     diabetes on medication.   "
127915|NCT01610765|"     This study is to identify if a Novel Antiviral Drug could be used to treat babies with Herpes     Simplex Virus (HSV) with central nervous system (CNS) disease. In this study the     investigators will identify the best dose for young children as well as identify additional     safety information about the Novel Antiviral Drug.   "
127916|NCT01610752|"     The purpose of this study is to determine how to help manage weight gain during pregnancy.     This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in     expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in     overweight and obese pregnant women.   "
127917|NCT01610739|"     This study aims to examine the effect of carpal tunnel release on blood flow to the median     nerve using SPY scope imaging to view the perfusion to the nerve.   "
127918|NCT01610726|"     The purpose of this study is to evaluate the health cost and clinical outcome by introducing     enhanced recovery (ERAS) compared to conventional recovery in colorectal surgery.   "
127919|NCT01610713|"     An open-label extension study in which patients with multiple sclerosis received GW-1000-02     [named Sativex® in Canada and also named Sativex® Oromucosal Spray] for four weeks in an     open-label manner.   "
127920|NCT01610700|"     A study to compare the efficacy of GW-1000-02 [named Sativex® in Canada and also named     Sativex® Oromucosal Spray] with placebo in relieving five key symptoms of Multiple Sclerosis     after six weeks of therapy.   "
127921|NCT01610687|"     An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02     treatment in multiple sclerosis.   "
127922|NCT01610674|"     OBJECTIVE/RESEARCH QUESTION Optimising glycaemic control during hospital stay reduces rate of     infections, length of stay and mortality,in particular in surgical patients. In guidelines     and literature recommendations on optimal perioperative diabetes care are described.     Nevertheless, in daily practice, perioperative glycaemic control is very often not achieved.     This study aims at developing an implementation strategy that is tested on feasibility to     improve perioperative diabetes care in terms of effectiveness, experiences and costs.      DESIGN/OUTCOME MEASURES/IMPLEMENTATION STRATEGY A step-wise implementation model is applied:     1) recommendations on optimal perioperative diabetes care (e.g. the administration of     intravenous insulin, encouragement of diabetes self-management) are systematically translated     into quality indicators; 2a) using these quality indicators, current care is measured by     performing a medical record search among 400 patients in 6 hospitals; 2b) barriers and     facilitators for optimal care are measured by performing interviews with professionals and,     e.g. regarding self-management, with patients; 3) based on this information an implementation     strategy is developed;4) implementation activities are enacted and 5) evaluated in a     controlled before-after design in 6 hospitals providing before and after intervention 400     patients.      DATA ANALYSIS To obtain an indication of the effectiveness of the strategy, baseline and post     intervention outcomes of intervention hospitals are compared with outcomes in control     hospitals, using the quality indicators. Experiences of participants in the intervention     hospitals will be measured to, if necessary, adapt the strategy to make it more effective and     acceptable.      ECONOMIC EVALUATION A cost analysis of the implementation strategy will take place.     Implementation costs will be related to the difference in percentage of patients treated as     described in the quality indicators before and after implementation. Information on the costs     and effects at the patient level will also be compared before and after the implementation of     the recommendations on optimal care.   "
127923|NCT01610661|"     The aim of this study is to determine the effect of habituation to diets with different types     of carbohydrate (simple-carb, refined-carb, unrefined-carb) on selected Cardiovascular     Disease (CVD) risk indicators.   "
127927|NCT01610609|"     Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by     race and low socioeconomic status. Statins have been shown to decrease the risk of     cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use     and overall declining CVD rates, disparities in statin use and disparities in the control of     high cholesterol by race, ethnicity, and socioeconomic status have persisted.      Objective: To improve the appropriate use of statins for primary cardiovascular disease     prevention among high risk individuals at community health centers through a system of     population health management that uses electronic health record (EHR) data to identify     patients for targeted education and outreach.      Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for     myocardial infarction or coronary death of 10% or higher to determine if the population     health management intervention, compared to usual care, results in higher rates of documented     statin treatment discussions within 6 months (primary process outcome), higher rates of     statin prescribing within 6 months (secondary process outcome), and higher rates of     significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C     ≥30 mg/dL lower than baseline (primary clinical outcome).      Aim 2: Interview patients who received the intervention to identify barriers to success      Aim 3: Assess the overall costs of the intervention and the costs per each patient who     achieves significant LDL-C lowering compared to patient who received usual care.   "
127928|NCT01610596|"     This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to     determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied     twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible     subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or     Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed     50 grams.   "
127929|NCT01610583|"     Background:        -  Health literacy means being able to understand basic health care information. This          information can include drug labels and prescription instructions. It can also include          doctor s instructions. Better health literacy can help improve a person s health          outcomes.        -  Many minorities have low health literacy. Latinos in particular have both low health          literacy and poor health outcomes. Language barriers such as poor reading skills can          contribute to problems with health literacy. Researchers want to develop a new health          literacy measuring tool. This tool will focus on genetic literacy, which involves          understanding personal risk of health problems. The tool will be written in Spanish. The          study will work with Spanish-speaking Latinos to develop and test this genetic literacy          tool.      Objectives:      - To develop a Spanish-language tool to study genetic literacy.      Eligibility:      - Spanish-speaking Latino adults between 18 and 75 years of age.      Design:        -  Participants will be screened with a brief interview. No personal samples will be          needed.        -  Participants will complete the genetic literacy questionnaire. It will be given in          Spanish.        -  The tool will ask about participants personal and family health history. It will also          ask about their understanding of genetic terms and genetic testing. Other personal          information, such as level of education, will be collected.        -  Participants will receive a gift card for completing the survey.        -  No treatment or genetic counseling will be provided as part of this study.   "
127930|NCT01610570|"     Background:      - Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted     against some forms of cancer, but was never accepted as a treatment. Research suggests that     it may be useful against some solid tumors, particularly Ewing sarcoma. Researchers want to     see if mithramycin can be used to treat solid tumors in children and adults. It will be     tested in different groups of people, including those with a type of Ewing sarcoma that     contains a chemical called Ewings sarcoma - friend leukemia integration 1 transcription     factor (EWS-FLI1).      Objectives:      - To see if mithramycin is safe and effective against solid tumors and Ewing sarcoma in     children and adults.      Eligibility:        -  Children and young adults between 1 and 17 years of age with solid tumors that have not          responded to standard treatment.        -  Adults at least 18 years of age with EWS-FLI1 Ewing sarcoma that has not responded to          standard treatment.        -  Children and young adults between 1 and 17 years of age with EWS-FLI1 Ewing sarcoma that          has not responded to standard treatment.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies and tumor tissue samples will be used to          monitor the cancer before treatment. Individuals with solid brain tumors will not be          eligible.        -  Participants will receive mithramycin every day for 7 days, followed by 14 days without          treatment. Each 28-day round of treatment is called a cycle.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Participants will continue to take the drug for as long as the side effects are not          severe and the tumor responds to treatment.   "
127931|NCT01610557|"     Background:        -  Diabetic macular edema is a common eye complication of diabetes. It causes the blood          vessels in the retina at the back of the eye to leak, causing swelling. The macula is          the center part of the retina that is important for seeing fine details and for tasks          such as reading, driving, or sewing. Swelling of the macula leads to vision loss and          possible blindness. Inflammation may play a role in diabetic macular edema. It is also          possible that there is a problem with the blood vessels and the blood supply to cells of          the retina.        -  A chemical in the body called vascular endothelial growth factor (VEGF) is important in          the formation of blood vessels in the body. Lowering VEGF levels may help treat diabetic          macular edema by reducing abnormal leaking blood vessels in the eye. Drugs that can          lower or block VEGF include ranibizumab and bevacizumab. Both drugs have been shown to          help treat diabetic macular edema. Researchers want to see if one of the drugs works          better than the other.      Objective: To compare the effectiveness of ranibizumab and bevacizumab injections for     diabetic macular edema.      Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least     one eye.      Design:        -  Participants will be screened with a physical exam and medical history. A full eye exam          will be performed. Blood and urine samples will be collected.        -  One eye will be selected as the study eye to receive treatment. If both eyes are          affected, both eyes may be enrolled in the study and receive different drug treatments.        -  The main part of the study will last for 9 months. At each study visit, participants          will have physical exams and eye exams. They will answer questions about their health          and any side effects from the drugs.        -  Participants will be assigned to one of four groups. Two groups will have two series of          ranibizumab and one series of bevacizumab shots. The other two groups will have two          series of bevacizumab and one series of ranibizumab shots. A series is three eye          injections of the same drug every 4 weeks. The injections will be given at these study          visits. The series order will vary for the different groups.        -  After 9 months, participants will continue to have additional study visits. If the          treatment seems to be successful, the study doctor may increase the time between visits.          Study injections may be given as needed every 4 weeks for up to 3 years.        -  Participants may have laser treatments in a study eye if needed. After being in the          study for 1 year, they may also have steroid injections or other treatments as directed          for the macular edema.   "
128548|NCT01602484|"     The investigators wish to perform a randomized controlled study to determine how much time     and money is saved by orthopedic foot and ankle surgeons through the use of prepared splint     packs compared to bulk supplies.   "
127932|NCT01610544|"     Background:      - Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans     are used to detect tumor responses to cancer treatment. However, it may be difficult to     detect early response to lung cancer or thymoma treatment with standard PET/CT scans. These     scans cannot easily show a difference between remaining cancer cells and inflammation.     Researchers want to try a new PET/CT scan tracer that may be able to show the difference     between these cells. 18F-Fluorothymidine (18F-FLT) is better at showing which cells are still     actively dividing. PET/CT scans with 18F-FLT may help show if tumor cells are responding to     early stages of treatment.      Objectives:      - To see if 18F-FLT is a safe and effective imaging study tracer to show early cancer     response to treatment.      Eligibility:      - Individuals at least 18 years of age who are being treated for lung cancer or thymoma.      Design:        -  Participants will be screened with a physical exam and medical history. Blood, urine,          and tumor tissue samples will be collected.        -  Participants will have two PET/CT scans on separate days before starting chemotherapy.          One scan will be with a standard radiotracer. The other will be with the 18F-FLT tracer.        -  About 2 weeks after starting chemotherapy, participants will repeat the two PET/CT scans          on separate days. Additional blood samples will be collected at this time.   "
127933|NCT01610531|"     Melanoma is nowadays an important public health problem because its growing incidence. Mass     screening for melanoma is not recommended worldwide because of its low cost-effectiveness.     Nevertheless targeted screening for patients at high risk for melanoma is promoted. This     study is designed to assess the effectiveness and the acceptability of a melanoma targeted     screening of melanoma, to estimate the risk function to develop a melanoma among patients at     high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma     targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a     registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk     according to the SAMScore were proposed a skin examination by their GP every year.   "
127934|NCT01610518|"     The ability of oat β-glucan to lower postprandial glycemic responses has been attributed to     the viscosity of the solution in which the fibre is solubilized. To our knowledge, no studies     have investigated the effect of β-glucan solutions on glycemic response when concentration,     and thus viscosity, is varied by changing the solution volume but not the β-glucan dose.     Therefore, the investigators will test the effects of altering β-glucan solution viscosity by     altering solution volume at a fixed amount of β-glucan fibre.   "
127935|NCT01610505|"     The purpose of the post-market study is to demonstrate that the KineSpring System is     non-inferior to high tibial osteotomy in safety and effectiveness in the treatment of     symptoms associated with osteoarthritis of the medial compartment of the knee.   "
127936|NCT01610492|"     This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety     and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R)     autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the     relationship between biomarkers, autoantibody status and clinical response. 10 milligrams per     kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then     every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive     IMGN followed by a further long term treatment period until subjects reach remission of     proteinuria, up to a maximum of 2 years total treatment. All subjects will receive background     supportive therapy throughout the study. The dosing frequency will be adjusted to every 2     weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is     greater than 1000 milligrams per millimole (mg/mmol) [greater than 10 grams(g)/24 hours (h)],     to compensate for loss of belimumab in the urine. Effects on mechanistic markers will be     measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various other     measures of kidney function. These will be compared to historical data. The pharmacokinetics     of belimumab will be measured to confirm dosing in heavily proteinuric subjects.     Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects will also     be investigated. Safety will be assessed by adverse events (AE), clinical laboratory     evaluations, and vital signs.   "
127937|NCT01610479|"     This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid     tumors.   "
127938|NCT01610466|"     Laparoscopic bariatric surgery is an advanced laparoscopic procedure with a potential for     significant morbidity and mortality along the early part of a surgeon's learning curve.     Simulation-based training has been shown to improve a surgeon's technical performance and     shorten the learning curves in the operating room. Despite these benefits, there is no     evidence-based ex-vivo training curriculum for laparoscopic bariatric surgery. The purpose of     this study is to design and validate such a curriculum. This curriculum will include     cognitive training, technical laparoscopic skills training (laparoscopic gastrojejunostomy     and jejunojejunostomy) and non-technical skills training in a simulated environment. The     investigators will assess the effectiveness of the proposed curriculum by conducting a     randomized single blinded controlled trial. Cognitive knowledge (multiple choice test),     technical skills (performance of a procedure in the operating room) and non-technical skills     (performance in a simulated crisis scenario in a simulated environment) will be compared     between curriculum trained and conventionally trained groups. The investigators hypothesize     that curriculum trained group will have superior knowledge, technical skill and non-technical     skills compared to conventionally trained group.   "
127939|NCT01610453|"     Objectives        1. To assess if head-perineum distance and angle of progression measured with transperineal          ultrasound by the obstetrician on call can predict delivery mode in primiparous women          with prolonged first stage of labour.        2. To compare ultrasound assessments and clinical examinations.   "
128054|NCT01608945|"     The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with     impairment of liver function. Perioperative steroid administration has been advocated to     reduce liver damage. The aim of this prospective, randomized study was to determine whether     steroid administration can reduce liver injury and impact the prognosis   "
128055|NCT01608932|"     The purpose of this study is to evaluate whether telemonitoring of frail patients with     chronic diseases produces benefits in terms of reduced readmissions, improved health related     quality of life, and improved health status. In addition, the trial evaluates the economic     and organisational impact of the telemonitoring service and examines its acceptability by     patients and health professionals.   "
127940|NCT01610440|"     Duchenne muscular dystrophy (DMD), an X-linked recessive genetic disease always progressed     slowly，tends to leading proximal skeletal muscle atrophy and weakness of limbs, as well as     impaired respiratory muscle and cardiac muscle. To a large extent, patients always lose motor     function gradually and die for heart failure or severe infection at the end stage of DMD. At     present, the treatment strategy relies on heteropathy accompanied with rehabilitation     training. However, the therapeutic effect remains extremely limited.      Human umbilical cord mesenchymal stem cells (hUC-MSCs) have been evidenced to improve motor     function, increase muscle strength and reduce abnormal levels of related enzymes, such as     creatine kinase (CK), lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and     aspartate aminotransferase (AST). This study is aimed to explore the safety and efficacy of     hUC-MSCs transplantation for DMD.   "
127941|NCT01610427|"     The purpose of this study is to investigate a combined set of parameters deemed to impact the     quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral     therapy-naïve HIV-1 infected subjects.   "
127942|NCT01610414|"     The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A     in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant     recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy     (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in     reducing the risk of developing HZ in this population.   "
127943|NCT01610401|"     In acute myocardial infarction early restoration of coronary blood flow is the most effective     strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates myocardial     injury and contributes to final infarct size, a process termed 'reperfusion injury'. Ischemia     and reperfusion (IR)-induced endothelial dysfunction seems to play a pivotal role in this     process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue.     Recently, it has been shown that the glucose-lowering drug metformin is able to limit     IR-injury in murine models of myocardial infarction, probably by increased formation of the     endogenous nucleoside adenosine. In the current research proposal, the investigators aim to     translate this finding to the human in vivo situation, using flow-mediated dilation (FMD) of     the brachial artery as a well-validated model of (endothelial) IR-injury.   "
127944|NCT01610388|"     This first time in human (FTIH) study will be the first administration of GSK1322322 as an     intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in     healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for     determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma     concentrations to evaluate drug penetration in the lung. The study will evaluate the absolute     bioavailability of an oral tablet formulation as compared to the IV formulation.In addition,     Amendment 01 will enable the investigation of an improved IV formulation (GSK1322322J     mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic cohort.   "
127945|NCT01610375|"     The aim of this study is to investigate the feasibility, safety and accuracy of a telephone     follow-up for women previously treatment for endometrial cancer.      To achieve this aim, potentially eligible women attending the Queensland Centre for     Gynaecological Cancer (QCGC) outpatient clinic for review following previous treatment for     endometrial cancer will be recruited by this study. The study aims to recruit all new     patients as well as all patients who return to QCGC for their follow-up and who had treatment     within the previous 2 years.      The proposed project will involve generation of an evidence-based checklist of signs and     symptoms of disease recurrence from a thorough literature review. The generated symptom     checklist will be pilot tested and the refined symptom checklist will be used to follow study     participants over a period of 12 months.      During the follow-up period, the basic standard of follow-up after primary treatment for     endometrial cancer at the QCGC, Royal Brisbane and Women's Hospital (RBWH)will not be     altered; however, the study participants will be interview via telephone 2 to 5 days prior to     their scheduled review dates.      The main outcome measure will be the estimated recurrence rate as derived from the telephone     assessment and this will be compared to the clinically detected recurrences as recorded in     patients' medical files.      It is hypothesized, that the telephone follow-up will identify 90% of all recurrences     correctly that are later confirmed during the clinical follow-up.      In addition to the main outcome, we will also assess patients' satisfaction with each of the     follow-up programs, whether or not lifestyle behaviours were queried and support offered to     improve wellbeing.   "
127946|NCT01610362|"     Dosage of rabies immune globulin was calculated from the victim's body weight, then the     amount of rabies immune globulin would be injected as much as possible to all of the wounds.     Increase dosage of rabies immune globulin was needed in situation of multiple severe     bite-wounds especially among children whose had lower body weight than adults. Our study     would be conducted in order to determine whether the increase dosage of rabies immune     globulin would interfere with the protective antibody levels against rabies.   "
127947|NCT01610336|"     This study will assess the safety and efficacy of escalating doses INC280 when added to     gefitinib in patients with lung cancer that are known to have dysregulation of the c-MET     pathway and who have failed after benefiting on a prior treatment with either gefitinib or     erlotinib.   "
127948|NCT01610323|"     In pregnancy, the adoption or pursuit of a sedentary lifestyle contributes to the development     of co-morbid conditions such as hypertension, maternal and childhood obesity, gestational     diabetes, pre-eclampsia, cesarean section and delivery of large-for-gestational-age infants     (LGA).      The aim of this study is to test the hypothesis that obese, pregnant women following a     supervised moderate intensity physical conditioning program during the 2nd trimester of     pregnancy will maintain a higher level of physical activity up to the end of pregnancy, as     compared to women in the control group. We will also conduct a pilot study on the feasibility     to examine the effects of the intervention on maternal fitness and neonatal anthropometry.   "
127949|NCT01610310|"     The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and     tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or     prefilled syringe (PFS) in healthy volunteers to support the development of the autoinjector.   "
127950|NCT01610297|"     This was a prospective, single-arm, multicenter, national, phase II clinical study. The     purpose of this Phase II study was to examine the safety and efficacy of deferasirox to     decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia     major.   "
127952|NCT01610271|"     Airborne particles are present in all indoor environments including the operating room. Most     of these particles come from the surgical staff moving around in the room, positioning of the     patient during surgery, and the movement of surgical equipment and supplies. While the amount     of particulate in an operating room is much, much less than is found in a typical home or     public space, some particulate is usually present no matter how the room and air are cleaned     and filtered. Typically these few particulate cause no problems, but the goal is always to     have the cleanest air possible during surgery. The Air Barrier System (ABS) consists of a     reusable blower and a sterile nozzle. The blower feeds filtered air into the sterile     disposable nozzle, which disperses a constant stream of gentle, high purity air over the     surgical incision. This stream of air forms a shield over the surgical area to prevent     airborne particulate from settling into the open wound. This is particularly critical for     long-duration surgeries, such as procedures that involve the implantation of a prosthesis.     The main objective of this research study is to determine whether the ABS can reduce the     potential for surgical site infection during total hip replacement, spinal fusion, or lower     extremity bypass grafting procedures. These procedures were chosen because each is a     long-duration procedure which involves implantation of prosthesis.   "
127953|NCT01610258|"     The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level     modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in     women hospitalized for PPROM.   "
127954|NCT01610245|"     This study is a global multicenter randomized factorial double-blind, placebo-controlled     trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally     twice daily for five days compared to a placebo in the treatment of acute uncomplicated     influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus     Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide     monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days)     in the treatment of acute uncomplicated influenza.   "
127955|NCT01610232|"     The investigators hypothesis is that the infrared-LED illumination during treadmill training     can enhance physical performance in postmenopausal women. The basis for such a hypothesis is     based on the fact that the light therapy during the intense metabolic stage caused by     exercise may be more efficient.   "
127956|NCT01610219|"     The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a     concerning public health trend. There has been little research testing ways to prevent the     development of this disease in children who are at increased risk to develop T2D. This study     tests a family treatment program that treats 4-8 year old children who are at risk for T2D     because they are overweight and have a family history of the disease. Sixty at risk children     and their parents were assigned to one of 2 treatment conditions. Half of the families     (randomly determined) received an intensive family treatment program that trains parents in     how to increase healthier foods choices and physical activity for themselves and their     children using behavior modification strategies. Children receiving this treatment were     allowed to taste new fruits and vegetables used a pedometer to record how far they walked     every day, and were given a tool box of toys and interactive games which promoted physical     activity. The other half of the families only received instruction about healthier choices,     but received no behavioral modification strategies or physical activity promotion tools.     Improvements in children's body weight, blood measures, and behavior patterns were measured     after treatment ended (6 months) and then again after 12 months. The results may lead to a     better understanding of how family members can positively influence young children's     behaviors to help prevent T2D. The objective of proposed study was to test a family-based     intervention designed to reduce excess body weight, improve metabolic and cardiovascular     profile, and improve diet and physical activity levels in 4 - 8 year old youth who are at     risk for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.      Primary Hypotheses:        1. Compared to children receiving NPA, children receiving LMDP will show greater reductions          in excess body weight, greater improvements in metabolic and cardiovascular measures,          improved diet, increased physical activity, and reduced television viewing.        2. Greater reductions in child excess body weight will be associated with greater          improvements in metabolic and cardiovascular measures.      Secondary Hypotheses:        1. Compared to parents receiving the NPA intervention, parents receiving the LMDP          intervention will show greater reductions in BMI.        2. Greater improvements in parent BMI will be associated with greater improvements in child          body composition, metabolic and cardiovascular measures, and behavioral outcomes.        3. Compared to families receiving the NPA intervention, families receiving the LMDP          intervention will show an increase in the number of fruits and vegetables and lower          energy density foods stored at home.   "
127957|NCT01610206|"     Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common     cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian     cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients     with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib     is a novel agent has recently been approved for the treatment of subjects with advanced renal     cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers     such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and     safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for     recurrent or persistent ovarian cancer. This is an open label study in which subjects will be     randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib.     Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle.     Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All     subjects will be monitored for toxicity and other indicators of safety (labs, physical exams,     vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5     years following the conclusion of treatment to evaluate efficacy. The primary endpoints of     the study are progression free survival and overall survival, which will be assessed at three     years.   "
127958|NCT01610193|"     PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and     the gut. There is evidence from experimental and clinical trials that the levels of PSP in     the blood rise in the presence of inflammation or infection. What is not yet well known about     PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in     predicting appendicitis in patients that present at the emergency room with abdominal pain     and a clinical suspicion of appendicitis.   "
127959|NCT01610180|"     With conventional treatments (i.e. iv Ig, steroids) the overall response rate of ITP     secondary to LPD is generally lower than in primary ITP, and usually not higher than 50% (95%     CI 27-72). Eltrombopag which has proved very effective in primary ITP could be effective also     in ITP secondary to LPDs.      This novel ITP specific treatment might spare these patients not only from bleeding risk but     also from toxic or inappropriate cytotoxic therapies, not otherwise demanded by the burden of     the underlying disease.   "
127960|NCT01610167|"     The study is intended to verify through clinical measurement that the NUPRO Sensodyne     Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended     relief up to 28 days.   "
128121|NCT01608074|"     Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral     salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the     investigators suggest, is to suppress the tubal source of possible dysplastic cells from     which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.   "
127966|NCT01610089|"     The urea cycle consists of a series of chemical reactions through which the body converts     toxic waste- nitrogen into a substance called urea that can be disposed of easily. While     disposal of nitrogen is the major function of the urea cycle, recent research has shown that     some enzymes of the urea cycle are also important for the production of nitric oxide. Nitric     oxide is an important chemical that has many functions in the human body including regulation     of blood pressure. Through this study, the investigators will study the production of nitric     oxide in subjects with citrullinemia type 1 by administering stable isotopes to these     subjects. Stable isotopes are harmless compounds that can be used to track and measure the     production of specific compounds in the human body. The overall goal of this study is to     understand if citrullinemia patients have a deficiency of nitric oxide production. This     knowledge may have an impact on the treatment of patients with citrullinemia.   "
127967|NCT01610076|"     This is a single-center, randomized control trial of a code status video as an educational     tool in the intensive care unit. Subjects are stratified by patient or surrogate and are     randomized to either watch an educational video on code status or not watch the video. They     are then asked knowledge base questions regarding code status as well as questions pertaining     to comfort regarding code status. Participants randomized to watch the video are also asked     questions related to acceptance of the video.   "
127968|NCT01610063|"     This was a study of a genotyping tool that reported on how subjects responded to medications     and could be used in a community psychiatry practice to improve medication choice for     depression. After the DNA test, an interpretive report was provided to the subjects'     physicians. The hypothesis of this pilot study was that it was feasible to use this     pharmacogenomic algorithm in a new setting to treat depressed subjects..   "
127969|NCT01610050|"     This study will evaluate safety and tolerability to determine the MTD/RD.   "
127970|NCT01610037|"     The study will assess the long-term safety of the fixed combination product QVA149 versus     placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary     Disease (COPD) patients with moderate to severe airflow limitation.   "
127971|NCT01610024|"     Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung     disease.      Using the already established pulmonary rehabilitation model, we aim to split the group of 8     into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on     alternate (differing) weeks to see if it improves their overall exercise tolerance.   "
127972|NCT01610011|"     The purpose of this study is to use proton magnetic resonance spectroscopy (MRS) at 4 Tesla     to measure brain glycine levels noninvasively at baseline and for 2 hours after a single oral     dose of a concentrated glycine-containing beverage, and to compare MRS glycine measurements     to glycine blood levels in samples obtained after each MRS spectrum.      The investigators hypothesize that they will observe a high correlation between the magnitude     increases in brain and plasma glycine levels over this time frame.      The investigators also hypothesize that we will observe large intersubject variability in     glycine uptake rates into brain and blood.      The investigators also hypothesize that subjects with a glycine decarboxylase (GLDC) mutation     (triplication) will have lower baseline plasma and brain glycine levels and will experience     smaller brain and plasma glycine increases after glycine consumption than controls or family     members without the GLDC mutation.   "
127973|NCT01609998|"     This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to     evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the     2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine.     The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis     is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and     more durable immune response than is observed in age-matched comparator TIV-TIV groups.   "
127974|NCT01609985|"     The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute,     prospective, non-randomized multi-center feasibility clinical trial. The purpose of this     clinical trial is to collect data to assist in the testing and finalization of a hemodynamic     sensor-based cardiac resynchronization therapy (CRT) optimization scheme.   "
127975|NCT01609972|"     The purpose of this investigational study is to establish the safety and effectiveness of     electrical stimulation delivered to the spinal cord in subjects with chronic, intractable     pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially     available SCS systems.   "
127976|NCT01609959|"     The purpose of this study is to compare blood pressure lowering effect of azilsartan with     that of valsartan in Japanese patients with hypertension who have already taken normal-dose     angiotensin II receptor blockers.   "
127977|NCT01609946|"     The study is an open, prospective multicenter study. According to the statistical sample size     calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the study.     Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or histology     obtained by surgery.      All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland,     as well as Realtime Elastography of thyroid nodules.      Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate the     additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.   "
127978|NCT01609933|"     A study to evaluate the safety and effect of treatment with experimental antiviral drugs in     combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who     did not respond to treatment in a previous AbbVie/Abbott combination study.   "
127979|NCT01609920|"     The aim of this study is to examine the diagnostic performance of gadofosveset enhanced     magnetic resonance imaging lymphography (MRL).      The diagnostic performance of MRL will be determined on the basis of a node-to-node matching     of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel     lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the     golden standard for nodal involvement.   "
127980|NCT01609907|"     The objective of this study is to compare pharmacokinetics after single oral administration     of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and     valsartan in healthy male volunteers.   "
129795|NCT01586195|"     This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf     (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic     melanoma and activating exon 15 BRAF mutations other than V600E.   "
127981|NCT01609894|"     The proposed research will investigate individualized fortification of breast milk based on     daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind     controlled trial. The combination of additional fat, carbohydrate and protein and commercial     fortifier will be added to ensure that the milk contains the target amounts of nutrient.     Growth and development of these infants will be compared with that of infants fed mother's     milk that has been supplemented with the current standard amounts. The postnatal growth of     the infants will be assessed by measuring weight, length and head circumference and fat and     lean mass using highly accurate, non-invasive methods throughout the intervention period and     at the first follow-up visit after discharge at 3 months. Neurological development will be     analyzed at the age of 18 months.      The investigators hypothesize that individualized fortification of breast milk improves the     nutritional intake of preterm infants, optimizing growth, and thus this will positively     impact neurodevelopment and health.   "
127982|NCT01609881|"     Objective of the research study:        1. To measure anterior chamber and vitreous ketorolac (Acuvail®) concentrations after          topical administration in patients undergoing routine vitrectomy to determine the          ability of the medication to penetrate into the anterior chamber and vitreous cavity,          and to compare these levels to the IC50 for the cyclooxygenase-1 and -2 enzymes (COX-1          and COX-2)        2. To measure vitreous concentrations of prostaglandin subtypes (PGE, PGD, PGF) and other          inflammatory mediators (Interleukin-1β [IL-1β], IL-6, IL-8, tumor necrosis factor          [TNF]-α, VEGF) in both diabetic and nondiabetic patients undergoing vitrectomy        3. To determine if topical ketorolac (Acuvail®) can penetrate the anterior chamber and          vitreous cavity sufficiently to decrease levels of intraocular inflammatory mediators          that have been shown to be elevated in diabetic patients        4. To serve as a precursor to a 5-year longitudinal clinical trial to determine if          chronically administered topical ketorolac (Acuvail®) can prevent, delay or slow          diabetic retinopathy.      Research hypothesis        1. Ketorolac (Acuvail®) will penetrate the anterior chamber and vitreous cavity          sufficiently to achieve levels above the IC50 for COX-1 and COX-2        2. Prostaglandin and other inflammatory mediator levels in the anterior chamber and          vitreous cavity will be significantly higher among diabetic patients than nondiabetic          controls        3. Acuvail® can significantly lower anterior chamber and vitreous cavity levels of          prostaglandins and other inflammatory mediators in diabetic patients   "
127983|NCT01609868|"     The investigators hypothesis that premature infants receiving a commercially available liquid     protein modular will have improved growth when compared with premature infants receiving a     commercially available powder protein modular.   "
127984|NCT01609855|"     The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at     time of caecal intubation, increases the adenoma detection rate.   "
127985|NCT01609842|"     Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure     performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant     therapy following PCI with stent placement and is generally recommended for up to 1 year     following the procedure. Despite the evidence supporting clopidogrel use, studies both     outside and within the VA suggest that poor adherence to clopidogrel is common. However,     prior interventions targeting non-adherence have not specifically focused on clopidogrel     adherence among PCI patients.      There are many potential reasons for early clopidogrel discontinuation that involve patient     and healthcare system factors. Patients reported the following reasons for discontinuing     clopidogrel within 1 month after drug-eluting stent (DES) implantation: 1) misunderstanding     the intended treatment duration; 2) conflicting recommendations about intended duration; 3)     cost of the medication; and 4) patients' own decision to stop. In contrast, patients who     continued to take clopidogrel reported the following as helpful: 1) communication such as     letters from their physician; and 2) receiving specific instructions on clopidogrel use.     These findings suggest that there are specific interventions that can be implemented to     improve clopidogrel adherence.      Multi-modal interventions that incorporate frequent follow-up, especially with pharmacists     and use interactive voice response (IVR) technology have improved medication adherence. IVR     technology is a computer-based telephone system which initiates calls, receives calls,     provides information, and collects data from users. IVR is currently a mainstay in the VA     where patients frequently interact with these automated systems to get clinic appointments     and/or refill prescriptions. IVR as part of multi-modal interventions have been well received     by patients, increased adherence to medications (e.g., statins), and improved clinical     outcomes (e.g., blood pressure, diabetes symptoms, health status). In addition, the     investigators have successfully used IVR as part of a multi-modal, multi-site intervention     including pharmacists to improve blood pressure levels among hypertensive patients.     Accordingly, the investigators have designed the intervention to improve clopidogrel     adherence that builds on the investigators' prior work and other successful adherence     interventions from the literature.      The investigators propose a hybrid effectiveness-implementation study of a multi-faceted     intervention to improve clopidogrel adherence at VA PCI centers. The investigators will use     the VA's Cardiovascular Assessment Reporting and Tracking (CART-CL), a uniform cath lab     procedure reporting tool at all VA cath labs. The intervention consists of 4 components: a)     an alert from CART-CL will be sent to an inpatient pharmacist prior to discharge that a     patient has received a stent; b) a pharmacist will bring clopidogrel to the patient's bedside     prior to hospital discharge as well as educate the patient on the importance of and adherence     to clopidogrel following PCI; c) interactive voice response (IVR) calls will be made to     patients prior to the time of clopidogrel refill to remind patients and to facilitate refills     during follow-up; and d) a Patient Aligned Care Team (PACT) member will contact patients who     delay filling clopidogrel.   "
127986|NCT01609829|"     The normal, the anticipated difficult and the unanticipated difficult airway are trained in     the patient safety simulation center (University Hospital Zürich) and the training is being     observed by video installation.      Step 1: normal airway (Phantom), technical training      Step 2: difficult airway (SimMan 3G), technical training      Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical     and non-technical (CRM - crew resource management) training.   "
127987|NCT01609816|"     This study uses a drug called dasatinib to produce an anti-cancer effect called large     granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as     natural killer cells that remove cancer cells. Researchers think that dasatinib may cause     large granular lymphocyte expansion to happen in patients who have received a blood stem cell     transplant (SCT) between 3 to 15 months after the blood SCT. In this research study,     researchers want to find how well dasatinib can be tolerated, the best dose to take of     dasatinib and to estimate how often large granular lymphocytic cellular expansion happens at     the best dose of dasatinib.   "
127988|NCT01609803|"     This research trial studies protein expression in tissue samples from younger patients with     rhabdomyosarcoma. Studying samples of tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors find better ways to treat cancer.   "
127989|NCT01609790|"     This partially randomized phase II trial with a safety run-in component studies the side     effects and how well bevacizumab given with or without trebananib works in treating patients     with brain tumors that have come back (recurrent). Monoclonal antibodies, such as     bevacizumab, may block tumor growth in different ways by targeting certain cells. Trebananib     may stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known     whether giving bevacizumab together with trebananib is more effective than bevacizumab alone     in treating brain tumors.   "
127990|NCT01609777|"     A handover Tool for doctors and nurses improves the quality of handovers compared to     handovers that are being conducted without a tool.      In the present study the investigators will develop and evaluate a handover Tool for doctors     and nurses. The investigators seek to answer the following research questions:        1. Does the tool improve quality (i.e. efficiency and accuracy)?        2. Does the tool improve safety relevant attitude an perceived team collaboration?   "
127991|NCT01609764|"     Ageing is associated with a reduction of physical activity, movement efficiency, and quality     of sleep. This leads to reduced health and well being in elderly subjects. Exercise training     can increase movement efficiency and quality of sleep.      Objectives:        1. Laboratory validation test of body acceleration based indexes for movement efficiency          and quality of sleep;        2. Cross-sectional analysis to assess relations between these indexes and age;        3. Intervention study to assess the effect of exercise training on daily life movement          efficiency and quality of sleep in ageing subjects      45 healthy human volunteers, age 50-83 yr, BMI 20-30 kg/m2 are divided in control or     intervention group. Subjects that will have practiced fitness activities in the previous     year, as well as pregnant or lactating women, will be excluded.   "
128056|NCT01608919|"     This study plans to learn more about the role of 2 blood tests in predicting who might     develop a blood clot in their arm or leg after major surgery. The investigators know that     patients who have cancer and major surgery have a higher than normal risk of getting blood     clots in the veins of their arms or legs. This can be very dangerous because the clot can     move into your lungs.   "
127992|NCT01609751|"     There is evidence to show that daily probiotic Lactobacillus casei Shirota (LcS) in the form     of Yakult fermented milk supports a healthy balanced population of friendly gut bacteria.     This, coupled with evidence from four European trials showing probiotic benefit for recurrent     diverticulitis and an understanding of how the disease develops, indicates that LcS may also     be beneficial. The investigators plan to undertake a pilot study investigating whether     consumption of once daily probiotic LcS as Yakult fermented milk would help either prevent     attacks of diverticulitis completely or significantly reduce frequency of attacks. Subjects     will be recruited from Surrey primary care units and will be closely monitored for 12 months     whilst being supplied with a daily dose of for the full 12 months to see if this improves gut     health.   "
127993|NCT01609738|"     Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right     ventricular apex (RVA) has become the most frequently used ventricular pacing site. However,     RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV     dysfunction and development of heart failure. Recent studies in animals have demonstrated     that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA     pacing and is able to improve LV function to a similar degree as biventricular (BiV) pacing.     In addition it was shown that a LV septum lead can be placed permanently by driving a lead     with extended helix from the RV side through the inter-ventricular septum into the LV     endocardial layer. This was shown to be a feasible and safe procedure and lead stability was     shown during four months of follow-up in otherwise healthy and active canines. LV septum     pacing may therefore be a good treatment alternative in patients with symptomatic     bradycardia, as well as patients with an indication for cardiac resynchronization therapy     (CRT). The purpose of this study is to translate the findings from preclinical studies to the     clinical situation by investigating the feasibility, long-term lead stability and safety of     LV septum pacing by transvenous approach through the inter-ventricular septum in patients.   "
127994|NCT01609725|"     Gingival inflammation has been associated with cardiovascular diseases, including heart     attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose     and C reactive protein. The treatment of gingival diseases decreases the concentration of     these risk factors in the blood of cardiovascular patients.   "
127995|NCT01609712|"     Patients with vertebral fractures often have problems to straighten and as a consequence of     impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to     the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer     expansion of the lung. Pain is also caused by respiratory excursions of the chest which     hinder the patients to use their entire lung volume.      Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing     stability to the fracture.      In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.   "
127996|NCT01609699|"     The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical     motion within fat tissues and cells for the purpose of producing mechanical cellular membrane     disruption. It is intended for reduction in body circumference.      The primary objective of this study is to evaluate the efficacy of the Contour I - Y System     on abdominal circumference reduction relative to baseline pretreatment values using different     treatment methods.      The primary efficacy endpoint in this trial is Statistical Difference of Circumference     reduction between Baseline measurement and at follow-up measurement.   "
127997|NCT01609686|"     Cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of     patients. Tranexamic acid (TXA) is a routinely administered antifibrinolytic agent that     reduces blood loss and blood transfusion requirement. However, standard dosing of TXA in     patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may     lead to higher blood concentration of TXA when compared to the patients with normal renal     function. Solid phase microextraction (SPME) is a fast and simple method to measure TXA     levels. This prospective study on cadiac surgical patients undergoing cardiopulmonary bypass     aims to study the pharmacokinetics of TXA in patients with renal dysfunction. Two patient     groups will be studied who will receive either TXA 50mg/kg bolus or BART regimen (30 mg/kg,     16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and     bleeding risk.      Hypothesis: Standard dosing of TXA used in cardiac surgery result in higher blood     concentration of TXA in patients with renal dysfunction when compared to patients with normal     renal function.   "
127998|NCT01609673|"     In the present study, the investigators propose a conversion scheme with 50% reduction in CNI     dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10     ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.      The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic®     and Certican® significantly improves renal function compared with the standard regimen of     CNI.   "
127999|NCT01609660|"     The purpose of this study is to assess the impact of probiotic administration (Saccharomyces     boulardii) on patients undergoing colorectal resections comparing to the routine protocol by     assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the     mucosa; (2) assess postoperative complications, mainly infectious and mortality, as well as     length of hospital stay   "
128000|NCT01609647|"     High platelet reactivity unit (PRU) after loading dose clopidogrel in patients undergoing     percutaneous coronary intervention (PCI) is related to high risk of short and long term     recurrent ischemic events including stent thrombosis.      The investigators hypothesize that additional loading of prasugrel in patients with high PRU     after clopidogrel loading would be superior to additional loading of clopidogrel in reducing     platelet reactivity and thereby result in lower risk of short term recurrent ischemic events.   "
128001|NCT01609634|"     This study is initiated to investigate the effect of a new infant formula in healthy term     subjects on growth, body composition, tolerance and safety.   "
128002|NCT01609621|"     The objective of this prospective, non-randomized, multicenter, post-market, observational     study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access     and to cross infrainguinal arterial occlusions.   "
128136|NCT01607879|"     This is a study of HMB plus amino acids in older men with prostate cancer starting androgen     deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional     supplementation will decrease the loss of muscle mass and strength that occurs when men start     ADT.   "
128003|NCT01609608|"     1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced          via a non-invasive oscillation platform could improve symptoms and health-related          quality of life (HRQOL) in patients with chronic functional constipation.        2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital          in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III          diagnostic criteria were included and randomized to either the WBV treatment or no          treatment (control) group. The treatment group received six 15-minute sessions of WBV          therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a          frequency of 12 Hz. The primary outcome was assessed by the constipation severity          instrument (CSI). The secondary outcome was improvements in HRQOL.   "
128004|NCT01609595|"     Beta thalassemia intermedia is an inherited blood disease caused by molecular mutations which     reduce the beta globin protein chain of adult hemoglobin A, the protein in red blood cells     which carries oxygen throughout the body. Beta thalassemias cause progressively severe     anemia, widespread organ damage, and often require blood transfusions. There is no FDA     approved therapeutic to treat the underlying cause of beta thalassemia. Fetal hemoglobin is     another type of endogenous hemoglobin which can replace the reduced beta globin protein,     reduce the anemia, and even abolish transfusion requirements. This type of hemoglobin is     normally suppressed in infancy.      Sodium 2,2 dimethylbutyrate (ST20, or HQK-1001) is a small molecule which stimulates     production of fetal hemoglobin in nonhuman primates and in human patients in Phase I/II     trials.      This is a Phase 2 open-label trial to evaluate the ability of this oral therapeutic to reduce     anemia in patients with beta thalassemia intermedia, when administered once daily for 26     weeks. All participants will receive the study drug.   "
128005|NCT01609582|"     The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite     events exists following long term treatment with TAK-875 compared with placebo.   "
128006|NCT01609569|"     The aim of this study is to determine on preliminary basis weather an elevated pro-calcitonin     level can be used to assess ischemia as a result of coronary artery complications during     percutaneous coronary intervention (PCI).   "
128007|NCT01609556|"     The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.   "
128008|NCT01609543|"     This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of     Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or     metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR)     activating mutations. Patients will receive Tarceva 150 mg orally daily until disease     progression or unacceptable toxicity occurs.   "
128009|NCT01609530|"     Verruca vulgaris (VV), or the common wart, is a relatively prevalent and often frustrating     cutaneous disease to treat. A single, highly effective therapy for the treatment of VV has     not been found. Liquid nitrogen is considered the standard of care for VV and studies report     a 44% to 47% cure rate. In search of more efficacious and convenient therapeutic options, a     variety of lasers have been reported in the treatment of VV including the Nd:YAG laser     (1064nm). Lasers offer the potential for decreased treatment associated pain, fewer office     visits, higher cure rates and lower recurrence rates. However, many of the available     published studies draw conclusions from case reports and small case series without any     randomized controlled trials. A randomized, controlled study is needed to evaluate the     efficacy of the microsecond Nd:YAG (1064nm) compared to conventional cryotherapy.      This study will use the Cutera CoolGlide Nd:YAG laser that operates in the infrared spectrum     at a wavelength of 1064nm. This a single site, double blind, randomized controlled clinical     trial to evaluate the efficacy of the Nd:YAG laser (Cutera) in the treatment of verruca     vulgaris of the hands and feet versus conventional liquid nitrogen therapy.      The investigators hypothesize that there will be a significantly higher number of warts with     complete resolution at 4 months follow-up in the Nd:YAG treated group versus the liquid     nitrogen therapy group. The investigators also hypothesize that there will be a faster time     to complete resolution of the verruca in the Nd:YAG treated group versus the liquid nitrogen     treated group.   "
128010|NCT01609517|"     In these prospective observational study, the investigators are trying to evaluate (1) the     influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal     anesthetic outcome by logistic regression analysis.   "
128011|NCT01609504|"     The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL     LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL     MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer     after Neoadjuvant Treatment.   "
128012|NCT01609491|"     In ophthalmic surgery the specific anaesthesiological challenges necessitate the     administration of a combination of relatively high doses of hypnotics and analgetics. In     order to preserve adequate organ perfusion, there is often a need to administer     pharmacological agents for haemodynamic support. Depending on the experience of the     anaesthetist a continuous infusion of phenylephrine or norepinephrine is used. It is     currently not known which of these agents has the most favorable haemodynamical profile.      Haemodynamic parameters (continuous blood pressure, cardiac index, stroke volume and systemic     resistance), peripheral tissue oxygenation and cerebral tissue oxygenation will be monitored     noninvasively using the Nexfin® , Inspectra®, and Foresight® and O2C® monitoring devices.   "
128013|NCT01609478|"     To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with     persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.   "
128057|NCT01608906|"     This study plans to learn more about what is the best treatment to prevent blood clots in     patients in intensive care units (ICU's). The investigators know that patients who are in     ICU's have a higher than normal risk of getting blood clots in the veins of their arms or     legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the     standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000     units at each dose). In this study the investigators are randomizing patients to receive     either standard of care or low dose intravenous heparin in a continuous infusion.   "
128202|NCT01607073|"     This study will assess how well the drug verapamil can improve control of seizures and     dysautonomia symptoms in children and young adults diagnosed with Dravet syndrome. The safety     of verapamil when given with all concomitant medications will also be assessed.   "
128014|NCT01609465|"     There is currently no published algorithm for secondary prevention prognosis of CHD that is     representative of the England GP-registered population and that includes both symptomatic and     asymptomatic patients (as identified through primary care). In this paper the investigators     will exploit routinely collected information in clinical practice to model CHD prognosis     based on a large contemporary open cohort of stable CAD patients. Although the investigators     model is based on data from GP practices in England only, the investigators believe that this     population is sufficiently heterogeneous in terms of ethnic mix, socioeconomic background,     predisposing characteristics and lifestyles to generate a prognostic model with good     generalizing power to the wider population.      Among the research questions the investigators will try to answer is whether established risk     factors for primary care prevention (smoking, hypertension, dyslipidaemia, diabetes) are also     reliable for risk-stratification of patients who have already developed CAD. Similarly, the     investigators will examine whether strong predictors of adverse outcomes in ACS patients in     the short term, such as admission SBP and heart rate, are also associated with their long     term prognosis.   "
128015|NCT01609452|"     The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when     administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura     (ITP).   "
128016|NCT01609439|"     The purpose of this study is to determine if pre-operative vitamin D supplementation lowers     the incidence of post-operative transient or permanent hypoparathyroidism in patients     undergoing total thyroidectomy.   "
128017|NCT01609426|"     The primary purpose of the study is to identify the factors of steroid dependency in     childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of     nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the     first manifestation. Different clinical and biological factors will be analyzed: age of first     manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization     in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes     involved in the response to steroid therapy.   "
128018|NCT01609413|"     In a crossover, single blind, randomized trial the calcium bioavailability of two calcium     supplements will be compared.That is AlgaeCal®(Algaecal Inc, Vancouver, Canada)(1 dose is 3     capsules of 180 mg calcium), derived from ocean algae and the proprietary calcium supplement     Caltrate 600® (Wyeth Consumer Healthcare, Inc).      After a screening visits 20 healthy male subjects aged 20-50 years will spend a day at the     research center to examine calcium bioavailability data. They will be randomized to consume     either first the AlgaeCal® supplement or the Caltrate 600® supplement. After a one week     wash-out period subjects will be supplemented with the other supplement. During the     examination day blood and urine samples will be collected before and until eight hours after     the supplementation for analyses of calcium, creatinine, phosphorus, albumin and 25 Hydroxy     vitamin D. Subjects are instructed to avoid taking calcium and/or vitamin D supplements 1     week before and during the entire study period. In addition, they are not allowed to take     medication that may affect calcium metabolism.      The hypothesis of the study is that calcium bioavailability of the AlgaeCal® supplement will     be higher than that of the Caltrate 600® supplement.   "
128019|NCT01609400|"     The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term     safety and evaluation if a satisfactory breast cancer screening can be performed in subjects     treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also     performed.   "
128020|NCT01609387|"     This study is a double blind randomized controlled trial.   "
128021|NCT01609374|"     This is a prospective, concurrently controlled, multi-center study to evaluate the safety and     effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior     cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy     with or without cord compression. Some participating sites will enroll just M6-C patients,     while others will enroll just ACDF patients.      Patients eligible for study enrollment will present with degenerative cervical radiculopathy     requiring surgical intervention, confirmed clinically and radiographically, at one vertebral     level from C3 to C7.      A total of 243 subjects will be included at up to 20 sites.   "
128022|NCT01609361|"     Rehabilitation program improves operative results following conventional open colorectal     surgery. Very few data are available on such program in laparoscopic colorectal surgery.   "
128023|NCT01609348|"     This study will test the use of venlafaxine to treat the depression in Alzheimer's Disease.     Venlafaxine works by increasing natural substances in the brain (serotonin and     norepinephrine) that help maintain mental balance. Alzheimer's disease (AD) is the commonest     neurodegenerative disease of aging and the cause of major financial and emotional burden to     patients, families and caregivers, and society. Depression is a very common symptom of AD,     affecting as many as 50% of patients over their illness. Depression in AD (Alzheimer's     disease) contributes greatly to patient disability and caregiver distress. Neither     psychosocial interventions nor psychotropic medications have proven effective to date for the     treatment of depression in AD.Venlafaxine is approved by the U.S. Food and Drug     Administration (FDA) for the treatment of major depression but it is not known whether or not     it can help depression in Alzheimer's Disease.   "
128037|NCT01609166|"     Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective     preventative treatment has been definitively demonstrated. This trial is conducted on the     basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS.      A randomized, double-blind phase III trial will evaluate 40 patients receiving their first     ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days.     Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be     applied to the hands and feet twice per day for 6 months after the start of capecitabine.     Patients will be examined every month and the investigators will take some photographs of     hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events     [CTCAE]v3.0) will be also collected at baseline and at the end of each cycle. The primary end     point is the incidence of moderate/severe HFS symptoms at the end of capecitabine treatment ,     based on the patient-reported dermatological exploration.   "
128038|NCT01609153|"     A study to examine whether an antipsychotic combination treatment of olanzapine and     amisulpride is more effective than olanzapine and amisulpride alone.   "
128024|NCT01609335|"     Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated     diagnostic criteria for AD where their role is to identify the pathophysiological processes     underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are     brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to     effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much     be divided into normal and abnormal ranges. This requires that a cut point(s) be established     in the continuous distribution of values for each biomarker.      The investigators objective in this proposal is to obtain imaging biomarker data in a group     of individuals who are appropriate for establishing normative values for AD biomarkers. The     investigators believe the most valid approach to establishing biomarker cut points is to base     them on the upper bound of the range observed in young to early-middle-age subjects in whom     the presence of occult AD pathology is extremely unlikely. Based on a large volume of     community-based autopsy data, that upper age limit would be about 50 years old. The lower age     bound for a group of subjects used to establish normative AD biomarker values would have to     be based on considerations of brain maturation, which may continue into the middle- to     late-20s. Thus, taking the above into consideration, the ideal age range for establishing     normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages     30-49 years old.   "
128025|NCT01609322|"     This project aims to test the efficacy of an in-home intervention, Activity, Balance,     Learning, and Exposure (ABLE), which integrates exposure therapy with cognitive     restructuring, exercise, and home safety evaluation for older adults with excessive fear of     falling. The intervention will be conducted by a licensed physical therapist. A control     intervention will be conducted by a health educator. The specific aims of the study are to     test the feasibility, acceptability, tolerability, and safety of the ABLE intervention.   "
128026|NCT01609309|"     -  Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally          invasive surgery has gained popularity for the treatment of early gastric cancer in East          Asian countries, even though the long-term follow-up outcome based on multicenter          randomized clinical trial (RCT) is still awaited.        -  For the patient with locally advanced gastric cancer, several studies indicated that          laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically          feasible and safe procedure by experienced surgeons in high-volume specialized          hospitals. However, the application of it is controversial mainly due to lack of solid          evidence on the oncologic efficacy. Therefore, conventional open approach is still the          current standard for advanced gastric cancer.        -  Nowadays, the proportion of patients with locally advanced gastric cancer is estimated          up to 80 per cent of all gastric cancer cases in China. Before the clinical application          of laparoscopic procedure for the treatment with curative intent to advanced gastric          cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must          be verified.        -  Accordingly,the comparison of intraoperative and postoperative complications between          laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with          gastric cancer based on a randomized controlled trial is needed.   "
128027|NCT01609296|"     The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug     Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral     and/or popliteal arteries in a real world patient population.   "
128028|NCT01609283|"     The purpose of this study is to determine determine the safety of intraspinal delivery of     mesenchymal stem cells (MSCs) to the cerebral spinal fluid of patients with Amyotrophic     Lateral Sclerosis (ALS) using a dose-escalation study.   "
128029|NCT01609270|"     Post-marketing surveillance registry of the CardioRoot graft.   "
128030|NCT01609257|"     The purpose of this study is to determine whether the norovirus vaccine is effective in     preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge     dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the     vaccine.   "
128031|NCT01609244|"     Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with     complex sleep apnea during continuous positive airway pressure (CPAP) treatment.   "
128032|NCT01609231|"     The purpose of this adaptive trial is to compare the progression-free survival of     participants with metastatic rectal carcinoma when treated with dalotuzumab + irinotecan     therapy relative to participants treated with cetuximab + irinotecan.   "
128033|NCT01609218|"     The study will evaluate effect of activated charcoal on absorption of LY2140023. The study     involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth two times     during study (once with activated charcoal, once without activated charcoal). This study will     last approximately 16 days not including screening. Screening is required within 30 days     prior to study entry.   "
128034|NCT01609205|"     The purpose is to study the relationship between RA disease activity based on Doppler     quantification and the subsequent clinical response (EULAR response) to treatment with     Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with     conventional clinical methods and semiquantitative Doppler assessment.   "
128035|NCT01609192|"     The project's background: Sickle cell disease is, at present in France, the most frequent     genetic illness. Recent progress in its treatment, in particular the use of hydroxyurea, has     considerably modified the prognosis of this disease. Many more patients now reach     reproductive age and do consider fathering. Exceptional studies have reported the potential     impact of this medical treatment on the sperm parameters and fertility of male patients. In a     retrospective analysis, the investigators found that the observed alterations of semen     parameters due to sickle cell disease seem to be exacerbated by hydroxyurea treatment.      The study hypothesis: A large prospective study is essential to assess the potential adverse     impact of the medical treatment of sickle cell disease on spermatogenesis and consider the     advisability of proposing sperm cryopreservation before this treatment is started.      Primary purpose of the protocol: evaluate the impact of a treatment by hydroxyurea (20-30     mg/kg/day), 6 months after its beginning, in 34 men with sickle cell disease (18-60 years     old). The main trial criterion will be the average difference of the concentration of     spermatozoa s (millions/ml) in the ejaculate, before and after 6 months of medical treatment.   "
128036|NCT01609179|"     A treatment protocol that enables patients to have continued access to IPI-926.   "
128041|NCT01609114|"     The concurrent use of chemotherapy during radiation therapy (CCRT) is now the important     treatment stratagem for locally advanced head and neck cancer or nasopharyngeal cancer (NPC).     For these cases, 5-Fluorouracil (5-FU) and cisplatin (CDDP) are the most commonly used agents     of CCRT. It plays an important role to improve the treatment outcome and increases the     opportunities for organ preservation.      In the past, Radiotherapy (RT) was solely used as a local treatment and its effect was     estimated by local effect model. However, growing evidence shows that irradiation has direct     DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, the     investigators reported that abdominal irradiation could significantly modulate the systemic     pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the     daily treatment dose for target treatment in an experimental rat model. Additionally, the     results from a clinical investigation showed that colorectal cancer patients with lower AUC     of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these     lines of evidence support the importance and necessity to search for the mediators     responsible for the unexpected effect of local RT on systemic pharmacokinetics of     chemotherapeutic agents, such as 5-FU.      In the present study, the investigators examined whether the phenomena and mechanism of     RT-PK(pharmacokinetics) is a fact for different anticancer drugs and for different part in     human.   "
128042|NCT01609101|"     In this randomised crossover trial we measure the space between the right side of the     laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with     a normal mouth opening. We compare the remaining spaces for seven different     videolaryngoscopes and compare these to a classic Macintosh laryngoscope.   "
128043|NCT01609088|"     The study will determine whether acute and chronic consumption of a beverage containing     erythritol will improve endothelial function in patients with type 2 diabetes mellitus.   "
128044|NCT01609075|"     This observational, multicenter, retrospective/prospective study will evaluate the use of     Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer.     Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy and     Avastin will be followed for up to 15 months.   "
128045|NCT01609062|"     The primary objective of this study was to evaluate the safety of a 2.0 mg/kg/week and a 4.0     mg/kg/week of BMN 110 in patients with Morquio A syndrome for up to 196 weeks. Secondary     objectives were to investigate the effect of the two doses on exercise capacity for up to 196     weeks. In addition, the pharmacokinetic (PK) parameters of both doses of BMN 110 was     assessed.   "
128046|NCT01609049|"     This prospective observational study will evaluate the efficacy and safety of peginterferon     alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including     participants with compensated liver cirrhosis, in clinical practice.   "
128047|NCT01609036|"     This observational study will evaluate the safety and efficacy of MabThera/Rituxan     (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected     for 3 years   "
128048|NCT01609023|"     This observational study will evaluate the safety and efficacy of rituximab in combination     with chemotherapy in first- and second-line treatment of participants with cluster of     differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be     collected from eligible participants receiving rituximab according to the Summary of Product     Characteristics (SPC) during 6 months of treatment.   "
128049|NCT01609010|"     This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan     (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with     follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either     MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day     subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375     mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle     of treatment. The anticipated time on study treatment is up to 6 months.   "
128050|NCT01608997|"     Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical     activity. When symptomatic, the injury affects all aspects of general health, quality of life     and function. Surgical intervention is recommended only if conservative treatment fails. The     purpose of the surgical intervention is to reduce pain, and improve function while improving     range of motion and muscle strength around the shoulder. The purpose of the current study is     to measure physical, functional, expectation, satisfaction and quality of life outcomes after     rotator cuff repair surgery. Another purpose is to learn the reproducibility components of     the above outcomes.   "
128051|NCT01608984|"     Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces     myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with     cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular     mechanisms leading to these effects are yet not fully understood. The purpose of the present     study is to validate previous studies and gather further evidence for RIPC during CABG with     blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during     Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular     mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.   "
128052|NCT01608971|"     Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of     heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies     suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding     complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a     protamine regimen based on the initial heparin dose before CPB might lead to overdose of     protamine. In contrast, a protamine regimen based on the actual heparin concentration may     avoid this condition. The investigators compare both regimens of protamine dosing in patients     undergoing complex surgery with CPB and assess its effect on the amount of protamine given,     markers of the coagulation system, utilization of blood products and perioperative blood     loss.   "
128053|NCT01608958|"     The study will evaluate whether prophylactic oxytocin administered in the third stage of     labor via IV infusion results in a lower mean blood loss compared to IM injection.   "
129269|NCT01593098|"     To prospectively determine the prevalence of colorectal neoplasia in siblings of Hong Kong     Chinese patients with advanced neoplasm compared with a sex and age-matched control     population. To determine the molecular alteration profiles of colonic adenomas in siblings of     patients with advanced neoplasm   "
128058|NCT01608893|"     Atrial fibrillation (AF) is the most common sustained heart rhythm disorder and is associated     with significant symptoms and health problems including an increased risk of stroke and     death. Current drug therapies are often ineffective and associated with significant side     effects. Abnormalities of calcium regulation in cells may lead to triggers for AF. Emerging     data suggest that abnormal intracellular calcium regulation mediated through the ryanodine     receptor in heart cells may contribute to AF. Recently the investigators have shown that the     β-blocker carvedilol which is most commonly used to treat patients with heart failure,     modifies calcium regulation mediated through the ryanodine receptor. At present this drug is     not frequently used to treat AF. Therefore the investigators will conduct a randomized trial     comparing carvedilol to metoprolol for prevention of paroxysmal AF. This may result in     improved health and quality of life for people who suffer AF.   "
128059|NCT01608880|"     Background:      Mastectomy flap necrosis (MFN) is a common complication that affects recovery, reconstructive     success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent topical vasodilator     that increases local blood flow by dilating arteries and veins without altering the ratio of     pre- to post-capillary resistance. There are no studies that evaluate whether the application     of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM) or nipple-sparing     mastectomy (NSM) and immediate reconstruction decreases the rate of mastectomy flap necrosis.      Objective:      To evaluate if the post-operative application of NTG ointment improve rates of MFN in     patients undergoing SSM or NSM with immediate breast reconstruction compared to patients     receiving placebo.      Hypothesis:      In patients undergoing SSM and immediate breast reconstruction there will be a decrease in     the rate of MFN in those who receive NTG ointment compared to those who receive placebo.   "
128060|NCT01608867|"     This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid     tumor for which there is no remaining standard curative therapy. Subjects will be assessed     for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim     analyses will be performed.      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon     enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will     receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days     following the discontinuation of OMP-54F28.      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects     will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose     escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses     between the dose levels listed above) may also be tested upon agreement with the     investigators and the study sponsor. In addition, alternate dosing schedule cohorts of     OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the     investigators and the study sponsor. These alternative less frequent dosing schedules may be     evaluated if emerging data suggest that once every 3 week dosing results in tolerability     concerns. The first 2 subjects enrolled in a cohort will not be treated on the same day. The     dose may be administered at any time during the day. Three subjects will be treated at each     dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences     a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a     DLT, no further subjects will be dosed at that level and 3 additional subjects will be added     to the preceding dose cohort unless 6 subjects have already been treated at that dose level.     Subjects will be assessed for DLTs from Days 0-28. Dose escalation for newly enrolled     subjects, if appropriate, will occur after all subjects in a cohort have completed their Day     28 DLT assessment. Subjects who have a >2-fold increase of their fasting β-CTX or a decline     of >3% in their bone mineral density (BMD) from screening or a T-score decline to <-2.5 in     the total femur or L1-L4 DEXA scan measurement will be started on zoledronic acid. Subjects     with stable disease or a response at Day 56 will be allowed to continue to receive OMP-54F28     until disease progression. An additional 6 subjects will be enrolled in an expansion cohort     at the highest dose level that results in <2 of the 6 subjects experiencing a Grade 3 (not     including a Grade 3 infusion reaction that resolves in 24 hours) or Grade 4 adverse event     (DLT). Tumors of particular interest for inclusion in the expansion cohort include sarcomas,     basal cell carcinoma, ovarian cancer, desmoid tumors and prostate cancer given the known     importance of the Wnt pathway in these malignancies.   "
128061|NCT01608854|"     In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup     around the spinal cord. The purpose of this study is to determine whether postoperative     antibiotic treatment continued for the duration of time a drain is in place results in a     lower infection rate than antibiotics given for only 24 hours postoperatively.   "
128062|NCT01608841|"     The purpose of this study is to investigate the influence of epidermal growth factor receptor     mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.   "
128063|NCT01608828|"     Studies suggest that strabismus has a negative impact on a person's self-image, interpersonal     relationships, emotional and psychosocial state (4-15). There are, however, few such studies     based in Asia, and the functional and psycho-social impact of disease is often neglected in     our management of strabismus in Singapore. The aim of this pilot study is to measure     quality-of-life (QOL) among strabismic children in Singapore so as to better understand the     functional and psychosocial issues faced by these children in their daily living. The     investigators also hope to evaluate the performance of the Intermittent Exotropia     Questionnaire (IXTQ) (2) and Adult Strabismus Quality of Life Questionnaire (AS-20) (1) and     to determine if differences between child and parental perceptions exist.      60 children with strabismus presenting to the KKWCH Eye Centre and their parents will be     invited to participate in the study and answer questions in 2 Pediatric Eye Disease     Investigator Group (PEDIG)-validated questionnaires (i.e. the IXTQ and AS-20). 30 children     aged 5-7 years will answer the 12-question IXTQ (5-7 years), while 30 children aged 8-16     years will answer the 12-question IXTQ (8-16 years) and the 20-question AS-20 questionnaires.     Their parents will answer the self-administered IXTQ child-proxy (12 questions), IXTQ     parental (17 questions) and modified AS20 child-proxy questionnaires (20 questions). For     comparison, 60 aged-matched children without strabismus or amblyopia (30 aged 5-7 years, and     30 aged 8-16) and their parents will also be invited to answer similar questionnaires     (controls).      Results will be analysed question-by-question and then by composite score, and comparison     will be made between child and parental-proxy measures, as well as with scores obtained from     myopic children. It is hoped, that from this study, we will be able to assess the usefulness     of the IXTQ and AS-20 instruments as measures of QOL in strabismic children, and to assess     the feasibility of its use in a larger study looking at the impact of strabismus and its     treatment in Singaporean children.   "
128064|NCT01608815|"     This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide     vaccine in Japanese participants to support registration of the product in Japan.      Primary Objective:      To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase     of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination     with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above.      Secondary Objectives:        -  To describe the safety profile of a single dose of typhoid Vi polysaccharide vaccine up          to 28 days after vaccination, in subjects aged 2 years and above.        -  To describe the immune response following a single dose of typhoid Vi polysaccharide          vaccine in subjects aged 2 years and above.   "
128093|NCT01608438|"     People with tetraplegia often retain some level of mobility of the upper body. The proposed     study will test the hypothesis that it is possible to develop personalized interfaces, which     utilize the residual mobility to enable paralyzed persons to control computers, wheelchairs     and other assistive devices. If successful the project will result into the establishment of     a new family of human-machine interfaces based on wearable sensors that adapt their functions     to their users' abilities.   "
129270|NCT01593085|"     The investigators propose a study that aims to develop a methodology for assessing this risk     and the psychological consequences of the malignancy in the palliative phase.   "
128065|NCT01608802|"     Despite overwhelming need for effective HIV palliative care in sub-Saharan Africa, a     systematic appraisal of the literature found almost no outcome or evaluative evidence.      Aim:      The investigators aim to evaluate the efficacy of HIV palliative care training and a simple     palliative care assessment tool provided to nurses of patients on Antiretroviral Therapy     (ART), and to evaluate this in terms of patient outcomes under clinical experimental     conditions in 2 African countries using randomised controlled trial (RCT) designs.      Intervention being tested:      Within each well-established HIV ART clinic, patients will be randomly allocated to either     continue receiving standard care (control group) or to receive standard care plus     appointments with a clinic nurse trained in basic palliative care (intervention group).      Methods:      Design: Each Phase III clinical trial (i.e. one trial in each of 2 countries) will be powered     and conducted in parallel to a common research design protocol, thus permitting evidence of     outcomes that reflects 2 different ART providers, providing evidence of palliative care     efficacy relevant to different HIV care settings.      Primary outcome: Each trial has been powered to a primary endpoint of pain control.      Secondary outcomes: The secondary outcomes are the core domains of palliative care as defined     by the WHO (i.e. physical, including symptoms, psychological, social and spiritual) and     measured by the APCA African POS. Further secondary outcomes measured will be: adherence to     treatment; risk behaviours; health-related quality of life; psychological morbidity.      Inclusion: Patients will be screened and invited into the trial if they are on ART, score 3-5     on the 0-5 APCA African POS pain or symptom items, are 18 years or older, and can give     informed consent to trial entry and data collection.      Analysis: An intention-to-treat analysis will be conducted to determine treatment response     differences between the two conditions. In order to maximise the efficiency of longitudinal     data, multi-level modelling will be applied as appropriate.   "
128066|NCT01608789|"     This study is a prospective, single arm, non-randomized, multi-center clinical study that     will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male     Sling in post-prostatectomy urinary incontinence.   "
128067|NCT01608776|"     To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care     (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).   "
128068|NCT01608763|"     The major objective of this project is to conduct a randomized controlled trial comparing the     impact of the normative feedback and other personalized feedback components of the Check Your     Drinking (CYD) Internet-based intervention in the general population. Eligible problem     drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design     - to receive just the normative feedback component of the CYD intervention, just the other     personalized feedback information, to a no intervention control condition, or to receive the     full CYD intervention. The no intervention control condition will not be sent any     intervention materials but will instead be sent a list of the different components of the CYD     feedback and will be asked to think about how useful they would find each of them. All     participants will be followed-up at 3 months.   "
128069|NCT01608750|"     The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI)     treatment in patients with functional dyspepsia.   "
128070|NCT01608737|"     The objectives of this study are:        1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335          (high dose given for 12 weeks or low dose given for 24 weeks both in combination with          Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in          treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.        2. Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in          combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in          chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV          treatment.   "
128071|NCT01608724|"     The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with     type 2 diabetes mellitus.   "
128072|NCT01608711|"     The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4     administered in combination with gemcitabine in subjects previously treated in protocol     2008002.   "
128073|NCT01608698|"     The purpose of this study is to evaluate different side effect in contraceptive use of two     oral combined contraceptive pills (OCP)in combination of 30 mcg ethinylestradiol/2 mg     chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®),     especially body weight change.   "
128074|NCT01608685|"     Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for     the detection of tuberculosis (latent or active infection) than the tuberculin skin test     (TST) in immunocompetent individuals. However, very little data are available concerning the     relative performance of IGRA and TST in immunosuppressed individuals from other causes than     HIV.      The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in     a group of renal transplant recipients under chronic immunosuppressive treatment for     detecting latent tuberculosis infection.   "
128075|NCT01608672|"     This is an observational study assessing patient satisfaction following at least 5 years of     BOTOX® treatment for glabellar lines.   "
128076|NCT01608659|"     This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A     for the treatment of facial lines.   "
128077|NCT01608646|"     In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin     chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.   "
128078|NCT01608633|"     Pain after dry needling or injection in the muscle is a frequent secondary effect in the     treatment of myofascial pain syndrome. In this trial spray and stretch technique is evaluated     as a method to reduce this soreness. As well, the characteristics and the different factors     that influence in this pain will be described.   "
128079|NCT01608620|"     Since uncontrolled observational studies first linked fructose to the epidemic of obesity     almost a decade ago, it has become a focus of intense concern regarding its role in the     obesity epidemic and increasing burden of cardiometabolic disease. Despite the uncertainties     in the evidence, international health organizations have cautioned against moderate to high     intakes fructose-containing sugars, especially those from sugar sweetened beverages (SSBs).     To improve the evidence on which nutrition recommendations are based, the investigators     propose to study of the role of fructose-containing sugars in the development of     overweight/obesity, diabetes, hypertension, gout, and cardiovascular disease, by undertaking     a series of systematic syntheses of the available prospective cohort studies. Prospective     cohort studies have the advantage of relating real world intakes of sugars to clinically     meaningful disease endpoints over long durations of follow-up. The findings generated by this     proposed knowledge synthesis will help improve the health of consumers through informing     recommendations for the general public, as well as those at risk of diabetes and     cardiovascular disease.   "
128080|NCT01608607|"     Since uncontrolled observational studies first linked fructose to the epidemic of obesity     almost a decade ago, it has become a focus of intense concern regarding its role in the     obesity epidemic. Despite the uncertainties in the evidence,the recommendations of     international health organizations have cautioned against moderate to high intakes     fructose-containing sugars, especially those from sugar sweetened beverages (SSBs). To     improve the evidence on which nutrition recommendations are based, the investigators propose     to study of the effect of fructose-containing sugar sweetened beverages (SSBs)on body weight,     by undertaking a systematic synthesis of the data taken from all available clinical studies     in humans. This technique has the strength of allowing all of the available data to be pooled     together and differences to be explored in groups of different study participants (healthy     humans of different sex, weight, and age and in those with diseases which predispose to     disturbances in metabolism, such as diabetes) with dietary fructose in different forms,     doses, and with differing durations of exposure. The findings generated by this proposed     knowledge synthesis will help improve the health of consumers through informing     recommendations for the general public, as well as those at risk of diabetes and     cardiovascular disease.   "
128081|NCT01608594|"     The purpose of this study is to evaluate the safety and potential effectiveness of a new     treatment for advanced and recurrent melanoma involving the combination of Ipilimumab and     IFN-α2b before surgery and to test for biomarker studies in blood and/or tumor to better     understand this disease, how best to treat it and what patients should be treated with this     combination.   "
128082|NCT01608581|"     The aim of this study was to evaluate the effectiveness of a targeted burn prevention message     on burn safety knowledge and behavior.   "
128083|NCT01608568|"     1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh     attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique     using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech     Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed     delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).      1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic     failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed     absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The     investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates.      2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with     self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals,     Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using     0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).      2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,     Canada) will be less costly than the standard fixation interrupted technique using 0     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).      2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.      2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based     on subjective surgeon satisfaction questionnaires.   "
128084|NCT01608555|"     The study will include 10 adult patients with cystic fibrosis. The aim of the study is to     evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial     load in the airways. Secondary end-point is the evaluation of variation in bacterial     susceptibility during and at the end of study period.   "
128085|NCT01608542|"     This is a single and multiple dose study in healthy male and female (of non-child bearing     potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib.     Fostamatinib is being developed for the treatment of rheumatoid arthritis.   "
128086|NCT01608529|"     It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with     the aim of increase nasal airflow resistance, therefore the objective was to examine the     effects of FeelBreathe with lung ventilation and gas exchange during exercise.   "
128087|NCT01608516|"     The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection     of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI     and US and to determine the contribution of each imaging technique. Current gold standard for     inflammation is histopathology.      Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with     atheromatous plaques in the carotid artery eligible for endarterectomy.   "
128088|NCT01608503|"     The subclavian vein (SCV) is a preferred site for placement of central venous catheter.     However, pneumothorax is a major concern during subclavian venous catheterization. Lung     deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the     distance between the pleura and the SCV. The investigators evaluated the effect of lung     deflation on the relative position between the pleura and the line of the imaginary needle     pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV)     using ultrasonography.   "
128089|NCT01608490|"     Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the     PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System   "
128090|NCT01608477|"     Over the past decades, survival rates in heart transplantation recipients improved     significantly, due to advancements in regimens of immunosuppressives and surgical techniques,     but are still limited to the first 12 months post transplantation. Long-term survival remains     almost unchanged indicating the need to identify and improve relevant factors. Evidence in     other chronically-ill patient populations shows that the healthcare system (e.g. level of     chronic illness management (CIM)) and patient self-management (e.g. adherence) drive     improvements in outcomes.      The BRIGHT study is the first multi-centre, multi-continental study examining healthcare     system and heart transplant centres chronic illness management practice patterns and     potential correlates of immunosuppressive medication nonadherence.      The knowledge gained will inform clinicians, researchers and healthcare policy makers about     the level(s) interventions need to be implemented at to improve long-term outcomes for     transplant recipients.   "
128091|NCT01608464|"     The purpose of this study is to improve their outcome by either changing the chemotherapy     drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will     improve their outcome.   "
128092|NCT01608451|"     Randomized Controlled Trial of Neoadjuvant Progesterone and Vitamin D3 in women with Large     Operable Breast Cancer and Locally Advanced Breast Cancer - A Feasibility Study      Primary Progesterone Timing of surgery during the menstrual cycle and its impact on survival     in premenopausal women with operable breast cancer has been extensively researched and     reinvestigated by Badwe et al in the randomized clinical trial of 'Primary Progesterone     Therapy for Operable Breast Cancer' at Tata Memorial Hospital. The underlying assumption was     that the presence of unopposed estrogen (in follicular phase) at the time surgery may be     deleterious for survival and that circulating progesterone might counteract this deleterious     effect.      Vitamin D3 The most prominent physiological role of hormonally active form of vitamin D3,     1,25-dihydroxyvitamin D3 (1,25(OH)2D3 or calcitriol), is regulation of calcium and     phosphorous homeostasis and bone metabolism via an intracellular receptor (VDR) which is a     member of steroid thyroid hormone super-family of receptors. The VDR receptors are also found     in other tissues like breast and prostate.      Vitamin D compounds have also been implicated in promotion of apoptosis in breast cancer     cells and evidence suggests that 1,25(OH)2D3 and its synthetic analogues may potentiate     responsiveness of breast cancer cells to conventional cytotoxic agents.      Objectives        1. To see the effect of primary progesterone on survival in women with high risk breast          cancer (large operable and locally advanced breast cancer)        2. To see the effect of Vitamin D3 as an antiproliferative, cytotoxic and apoptotic agent          (negative growth regulator) by evaluation of surrogate markers of proliferation and          apoptosis.      Inclusion Criteria:        -  Unilateral breast cancer        -  Large operable breast cancer/LOBC (T3N0M0 or T3N1M0) and Locally advanced breast          cancer/LABC (T3N1-2M0; T2N2M0)        -  Age <70 years        -  Fit for CT      Exclusion Criteria:        -  Prior Incision Biopsy or Excision Biopsy        -  Metastatic breast cancer        -  Renal failure or deranged Renal Function Test        -  Hypoparathyroidism        -  Pregnant or lactating mothers or women of childbearing age not practicing contraception        -  Patient on any of the following drugs: Magnesium-containing antacids, Digitalis,          Phenytoin barbiturates, Thiazide diuretics.        -  Previous history of other cancers except cured skin and cervical carcinoma in situ.      Methodology / Treatment plan      The study drugs (Injectable Progesterone and Vitamin D3) will be tested in the neoadjuvant     setting prior to administration of each chemotherapy cycle, in a 2x2 factorial design as     below:      Neoadjuvant D3 will be administered as Inj. Arachitol 300,000 IU/ml intramuscular, before     each chemotherapy cycle.      Neoadjuvant Progesterone used will be administered as single IM depot injection 500mg 5 days     prior to each CT cycle and surgery date.      Primary Objectives Disease-free survival      Secondary Objectives Improvements in overall survival Tumor response   "
128094|NCT01608425|"     Telemedicine technology enables a direct and online text- and image communication in the     treatment system from patient to the ulcer specialist. The technology is expected to have     patient-related, economic and therapeutic benefits. The study is a substudy of a larger     project entitled Renewing Health, where also the economic and management aspects are     highlighted. However, only few randomized prospective studies are conducted in this field.     The purpose of the study is in a randomized prospective study, to assess the impact of the     introduction of the telemedicine technology as consultation form between ulcer-nurses in the     primary sector and the wound clinics at the hospitals in the region. It is assessed whether     the technology can be adopted without incurring the patient a risk. The study aims to perform     an impact analysis of the introduction of new technologies for telemedicine wound monitoring     in the treatment of diabetic foot ulcers through different studies.   "
128095|NCT01608412|"     The study hypotheses to be tested in this study are:        -  Conversion to everolimus at 3 months post-transplantation is safe and effective;        -  Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months          pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection,          tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant          recipients;        -  Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can          be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant          recipients.   "
128096|NCT01608399|"     The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for     major depressive disorder. Additional aims are to (2) investigate patterns of change and the     mechanisms of action involved during treatment, and to (3) examine the impact of     meta-cognitions in the treatment and relapse prevention of depression.   "
128097|NCT01608386|"     Anterior approach results in better operative and survival outcomes compared with the     conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior     approach has the problem of bleeding from the hepatic vein.      Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce     blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC     clamping may also reduce blood loss in anterior approach right hepatic resection. So the     investigators conduct this prospective, randomized, controlled trial to compare anterior     approach combined with infrahepatic IVC clamping and anterior approach in major right     hepatectomy for large HCC.   "
128098|NCT01608373|"     This prospective randomized study aims to comparison the effectiveness of intravenous     lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in     patients undergoing laparoscopic cholecystectomy.      A total of 83 patients will be randomized into one of three groups (group C or group I or     group P) based on Excel number generation.      Patients in group C will receive normal saline intravenous injection, and patients in group I     will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous     lidocaine infusion of 2 mg/kg/hr.      Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg     lidocaine and normal saline 100cc.      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients     pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8,     12, 24, 48 hours postoperatively.   "
128099|NCT01608360|"     This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine     injection on the relief of pain in patients undergoing thyroidectomy.      A total 56 patients will be randomized into one of two groups(group C or group I) based on     Excel number generation.      Patients in group C will receive normal saline intravenous injection, and patients in group I     will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous     lidocaine infusion of 2mg/kg/hr.      Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients     pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of     nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.   "
128100|NCT01608347|"     Recurrent miscarriage (RM) is traditionally defined as three or more consecutive miscarriages     occurring before 20 weeks post-menstruation. It is one of the most common clinical problems     in reproduction, yet a definite cause can be established in only 50 percent of cases (ACOG     practice bulletin, 2002). Many etiological factors have been proposed but none of them has     been fully substantiated. RM has been directly associated with maternal thrombophilic     disorders, parental chromosomal anomalies, and structural uterine anomalies and indirectly     with maternal immune dysfunction and endocrine abnormalities.      The association between pregnancy loss and antiphospholipid antibodies (aPL) was first     noticed in the latter third of the last century. The antiphospholipid syndrome (APS) is     characterized by the presence of antiphospholipid antibodies (APLA), associated with venous     and/or arterial thrombosis, and/or pregnancy loss. The adverse pregnancy outcomes associated     with the presence of APLAs include: recurrent fetal loss, intrauterine growth restriction     (IUGR), and severe pre-eclampsia especially of early onset.      Testing the effect of Heparin in treatment of cases with RA but negative for APA has bee done     in few animal and clinical studies. Animal studies showed that the subset of cases with     disorders suspicious for APS but who had negative test results for LAC and aCL is carrying     antibodies pathogenic to murine pregnancy. Testing other immunoglobulin G may provide     additional means to identify cases with an yet uncharacterized immune condition. Moreover,     the clinical relevance of low levels of APLA in these women remains unproved.      Randomized prospective study was done to assess the efficacy of early thromboprophylaxis of     Low molecular weight heparin (LMWH) (Enoxaparin sodium 20 mg, once daily subcutaneously) in     women with a history of recurrent miscarriages without identifiable causes versus no     treatment. The results showed that, there is a significant reduction in the incidence of both     early and late miscarriages (8.8% vs 4.1%) (2.3% versus 1.1%) with or without treatment,     respectively.      Cochrane Database systemic review (2005) shows randomized comparative studies for treating     recurrent miscarriage in women without antiphospholipid syndrome. The first group treated by     low dose aspirin alone and the second group treated by low dose aspirin + LMWH. The result of     these studies shows that no significant differences between the two groups and identify the     need of large randomized controlled trial to solve this problem.      The above evidence suggests the probability of presence of untested LAC and aCL or very low     levels of APLA by commonly used methods in women with recurrent miscarriage. These antibodies     may explain recurrent miscarriage in cases with negative antiphospholipid antibodies. It     remains to test the efficacy of heparin (proven effective treatment in those with positive     antibodies) in the patients with negative antibodies. Finding a solution to this frustrating     problem may open the way for an unsolved problem.      The proposed study is an open labeled randomized controlled trial (RCT) To evaluate the     effect of LMWH versus no heparin in treatment of recurrent miscarriage that is negative for     antiphospholipid antibodies testing.   "
128101|NCT01608334|"     Adequate sensory block for surgical procedure without side effects and immediate mobilization     after surgery are desirable anesthetic technique in various surgeries. Considering the     sensory innervations to the prostate, a sensory block up to L1 - T12 is adequate to the TURP.     Low-dose intrathecal local anesthetics may meet these criteria, but occasional lack of     sufficient sensory block could be troublesome. In this randomized study, the investigators     evaluated the spinal anesthetic characteristics following intrathecal administration of     bupivacaine 1 mg with fentanyl or sufentanil in elderly patients undergoing TURP.   "
128102|NCT01608321|"     This study was designed to evaluate the effect of repetitive Transcranial Magnetic     Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the     first Gulf War (GW1) who often suffer from chronic pain problems.   "
128103|NCT01608308|"     The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe     and efficacious agent in reducing post-operative pain; we hypothesize that its use will     reduce post-operative pain when compared to a control group using the visual analogue score     (VAS) analog pain scoring system.   "
128104|NCT01608295|"     The purpose of this study is to examine the effects of vilazodone for the treatment of     depression in older adults.   "
128105|NCT01608282|"     OPEN (Osteoarthritis Physical Activity and Exercise Net) is a website created based on a well     developed behavioural theory. This intervention is developed for people with early knee     osteoarthritis (OA) who have been sedentary. The investigators aim to engage these     individuals to become physically active at a time when their joint symptoms tend to be mild.     The primary goal of this proof-of-concept randomized controlled trial is to determine if the     OPEN website plus an information pamphlet about OA will improve participation in physical     activity in persons with early knee OA, compared to those who receive only the pamphlet.   "
128106|NCT01608269|"     The purpose of this study is to assess the safety, tolerability, and antivira activity of     Epzicom in virologically controlled HIV subjects.   "
128107|NCT01608256|"     The Purpose of this study is to assess the effect of MCI on driving ability by using on road     driving test. The relationship between their driving outcome and their cognitive decline will     be examined.   "
128110|NCT01608217|"     This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre     study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain     in patients with mild to severe dementia, when added to an analgesic treatment with     acetaminophen.      It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo,     when added to an analgesic treatment with acetaminophen, and as measured by a change in     Neuropsychiatric Inventory (NPI) score, after a three week treatment period.      It is expected that this will be due, primarily, to psychoactive effects of Namisol® and     secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is     expected that a reduction in NPS will positively affect quality of life and lead to better     functioning in daily living.   "
128111|NCT01608204|"     The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST     (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be     utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is     only checking the GST gene and MDR-1 gene   "
128112|NCT01608191|"     The aim of this study is to evaluate if an internet-based CBT (Cognitive Behavioral Therapy)     programme for weight stability after LCD (Low Calorie diet) treatment for obesity, can reduce     weight gain and improve weight stability, self reported health, pain, eating behavior,     fatigue and mood.      Adults with obesity and health problems in primary health care are invited to be part of the     study. The geographical area is Orebro county which has in all 29 primary health care     centers. Population is 276 000, and according to population studies around 15% of the adult     population has a BodyMassIndex (BMI) over 30, which is characterized as obesity according to     WHO.      Specific objectives are;        -  To evaluate if internet-based CBT treatment after LCD improves weight stability after 1          and 2 years.        -  To evaluate if weight loss improves metabolic parameters such as HbA1c, blood glucose,          Cholesterol, Low density lipoproteins (LDL),High density lipoproteins (HDL) ,          triglycerides (TG) and Bloodpressure (BP)        -  To evaluate weight loss influence on quality of life, body pain, eating behavior,          obesity related problems, fatigue and mood, and to see if CBT program for weight          stability also improves these factors        -  To evaluate if LCD treatment is a possible treatment for obesity in ordinary primary          health care      Patients taking part in the study, undergo a 12 week period of Low Calorie Diet (LCD)     treatment, followed by a 12 week reintroduction to ordinary food. During this period the     patient has contact with the primary health care nurse and doctor. After 24 weeks of     treatment, the patient who follows the study is supposed to have lost around 10% of initial     weight.All patients losing more than 7% weight during the first 24 weeks, are randomized to     either ordinary follow up (group 1) or an internet-based CBT programme for weight stability     (group 2). All patients in the study are followed at 1 year by doctor, and at 2 year by nurse     visit.   "
128113|NCT01608178|"     Background:      - Succinic semialdehyde dehydrogenase (SSADH) deficiency is a rare genetic disease that     results in changes to certain brain chemicals. These chemicals may affect brain excitability,     or how likely nerve cells are to turn on. Changes in brain excitability may help to explain     the symptoms of the disease, including learning and memory problems, seizures, and poor     balance. A supplement called taurine may help people with SSADH deficiency by working on the     brain chemical GABA. GABA helps to regulate brain activity. Researchers want to see if     taurine can help people with SSADH deficiency.      Objectives:      - To learn more about how taurine affects the brain in people with SSADH deficiency.      Eligibility:      - Individuals at least 12 years of age who have SSADH deficiency.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide blood and urine samples. They will also take taurine supplements as part of this          protocol.        -  Participants will have two sets of study tests. One set will be given while participants          are taking taurine. The second will be given when they are not taking it. Each testing          session will take about 2 days to complete.        -  Half of the participants will have the off taurine testing before starting on the          taurine supplement. The other half will start taking taurine first, have the on          taurine testing, and have the off taurine testing about 3 months after stopping          taurine. Participants may decide the order in which they will have the testing done.        -  Participants will have the following tests at the two test visits:        -  Paper and pencil tests of learning and memory.        -  Transcranial magnetic stimulation to study the excitability of nerve cells.        -  Imaging studies to show GABA receptors in the brain and measure their activity.        -  Electroencephalogram to measure brain waves.        -  Lumbar puncture to collect spinal fluid.        -  Participants will be monitored with regular study visits while they receive the taurine          supplement treatment.   "
128114|NCT01608165|"     The number of people diagnosed with kidney cancer has doubled over the past 20 years, making     it the eight most common cancer in the UK. Most tumours are less than 4cm in size, but over     80% of these are malignant (cancerous) and if left untreated, will slowly grow and spread.     Current standard treatment for these small kidney cancers is to remove the diseased part of     the kidney in an operation called a partial nephrectomy, but this can be quite a difficult     operation. Because of the small tumour size and difficulties with the operation, other     treatments have been developed to destroy the tumours. These treatments include     radiofrequency ablation, which means that the tumour is destroyed by heat, and cryoablation,     which means that the tumour is frozen and destroyed.      Although removing the part of the diseased kidney in an operation is the tried and tested way     to treat the kidney cancer, it does have risks and complications, such as bleeding. The other     two treatments are less intrusive to the patient, and are less complicated as they do not     require such a large operation as having part of the kidney removed, but it is not known if     they are as good at destroying all of the tumour, and whether or not patients who have their     tumour destroyed with these new methods require further treatment in future.      In this study, the investigators are trying to determine if a large-scale study comparing     these treatments is possible which is why this is called a feasibility study. The     investigators are also looking at whether patients would be willing to be randomly assigned     to a treatment group. The results of this study will then be compared to see how effective     each of the treatments were and whether the number of patients who were happy to be randomly     assigned to a treatment could be used to determine the number of patients required in a     large-scale trial.   "
128115|NCT01608152|"     Objectives:      Aim 1. Develop a prototype intervention electronic game that implements a baseline testable     feature set, including features for social networking within a virtual game space, managing     an intermittent mediated reward cycle, goal setting and tracking, and collaborative problem     solving.      Aim 2. Evaluate the technical merit, feasibility, user perception and acceptance of the     prototype system with adolescents and young adults (AYAs) allogeneic hematopoietic stem cell     transplantation (HSCTs) patients in recovery.   "
128116|NCT01608139|"     The goal of this clinical research study is to learn the highest tolerable dose of the     combination of curcumin, vorinostat, and sorafenib that can be given to patients with     advanced solid cancer. The safety of this drug combination will also be studied.   "
128117|NCT01608126|"     The purpose of the study is to compare efficacy, complications and safety of the standard     method of Combined (superficial and deep) cervical plexus block (SDCPB) with Ultrasound     guided Medial Cervical plexus block technique (MCPB).      Hypothesis: Ultrasound assisted MCPB is safer than SDCPB with similar efficacy.   "
128118|NCT01608113|"     Treatment naive patients with subfoveal nAMD initially treated monthly with intravitreal     anti-VEGF and subsequently PRN, will be included in this study. Patients will be investigated     for the first 2 years monthly and subsequently according to disease activity but at least     every two months. Patients will be examined with 4m BCVA ETDRS distance visual acuity,     reading acuity measured by Radner-Reading-Charts, contrast sensitivity by Pelli-Robson score,     microperimetry and HD-OCT.   "
128119|NCT01608100|"     The objective of the study is to evaluate the performance and intended use of a new cardiac     biomarker test, Troponin I, in an intended use population. Blood specimens will be tested     using the new investigational test that detects the level of Troponin I. Results will be     compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.   "
128120|NCT01608087|"     This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish     pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.   "
128122|NCT01608061|"     The primary objective of this feasibility study is to evaluate the safety of DBS-f in     patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse     events. The secondary objective is to preliminarily estimate the treatment effect size on the     outcomes of interest at 12 months post-randomization. The objectives do not involve formal     tests of hypotheses.   "
128123|NCT01608048|"     The objective of this study is to investigate the effect of transcutaneous electrical     acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.   "
128124|NCT01608035|"     The goal of this study is to determine if pre-operative placement of the continuous     peripheral nerve block by an anesthesiologist using ultrasound technology is more effective     than a continuous peripheral nerve block placed during the surgery by a surgeon for patients     undergoing a limb amputation   "
128125|NCT01608022|"     Esophageal cancer (EC) is the eighth most common cause of cancer-related death in the     worldwide. Systemic chemotherapy in patients with metastatic EC has limited effectiveness,     resulting in a median survival of 8 months to 10months. The low activity and brief duration     of benefit for chemotherapy to palliate advanced disease make clear need to identify new     active agents.      Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to     poor prognosis in patients with EC. The association between EGFR-activated signaling pathways     and tumor cell survival are well documented in many studies. Some EGFR tyrosine kinase     inhibitors (TKIs) already showed clinical efficacy against EC. A study with erlotinib showed     objective response rate of 15% (2 of 13 patients), but activity was limited to squamous cell     type.8 In another study, thirty patients with malignant solid tumor were treated with     BIBW2992, irreversible inhibitor of EGFR and HER2, and one of four EC patients achieved     partial response.      PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In     preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines     engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth     inhibition in gefitinib-resistant xenografts. PF-00299804 reportedly have clinical anti-tumor     activity in patients with non-small cell lung cancer and head and neck squamous cell     carcinoma with manageable toxicity.      The aim of current trial is to evaluate the antitumor efficacy and safety profile of     PF-00299804 and to identify biomarker to predict the tumor response to PF-00299804.   "
128126|NCT01608009|"     The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to     pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and     paclitaxel in platinum-resistant ovarian cancer patients.   "
128127|NCT01607996|"     The aim of the study is to evaluate the safety, the potential beneficial effect of epidural     anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute     pancreatitis.   "
128128|NCT01607983|"     The study involves documenting the effects of inhaled nitric oxide upon ventricular-arterial     coupling in patients with congenital heart disease and passive pulmonary blood flow.     Consenting patients undergoing a clinically-indicated cardiac catheterization will be given     inhaled nitric oxide for 10 minutes while intraventricular pressure-volume analysis will be     make via conduction catheters.   "
128129|NCT01607970|"     The purpose of this study is to determine whether oxytocin affects the modulation of startle     reactivity by aversive social stimuli and to investigate the oxytocin effect on moral     judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR)     polymorphisms on behavioral responses to social stimuli.   "
128130|NCT01607957|"     The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in     patients with refractory metastatic colorectal cancer.   "
128131|NCT01607944|"     Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are     glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the     glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic     endocrine function and incretin metabolism are impaired. The investigators hypothesize that     extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in     subjects with type 2 diabetes.      Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief,     somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of     insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be     studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject will     undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or GIP.     Glucose metabolism will be assessed using 13C-glucose stable isotope methodology combined     with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and     flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and     abdominal adipose biopsies will be taken to examine intracellular signalling.   "
128132|NCT01607931|"     Human volunteers will be stratified by oral glucose tolerance status: normal glucose     tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4     experimental trials: [1] an oral glucose tolerance test (OGTT) combined with infused and     ingested stable isotopes of glucose to assess glucose kinetics. [2] a 1 hour bout of cycling     exercise at 50% of maximum power output, immediately followed by the same OGTT combined with     stable isotope glucose tracers used in trial 1. [3] an isoglycemic clamp to match the plasma     glucose profile measured in trial 1. [4] a 1 hour bout of cycling exercise at 50% of maximum     power output, immediately followed by an isoglycemic clamp to match the plasma glucose     profile measured in trial 2.      Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon     secretion, and the incretin effect will be examined. The exercise responses will be compared     between the subjects groups of different glucose tolerance status.   "
128133|NCT01607918|"     The investigators aimed to compare the eradication rates of sequential therapy for 10 days     versus triple therapy for 14 days   "
128134|NCT01607905|"     Phase 1 study to evaluate the safety and tolerability of KPT-330 and determine the     Recommended Phase 2 Dose (RP2D) of KPT- 330 for advanced or metastatic solid tumor     malignancies.   "
128135|NCT01607892|"     The purpose of this research study is to find out more information relating to the highest     dose of KCP-330 that can be given safely and side effects it may cause, to examine how the     body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the     effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its     effectiveness in treating cancer.   "
128137|NCT01607866|"     The most common benign tumor of the parotid gland is the so called pleomorphic adenoma.     Although benign, this tumor may recur after surgical removal due to tumor cells left behind     during the surgical operation. Thus, pleomorphic adenomas have been treated with wide     resection similar to malignant tumors. This extensive surgery often leads to injury to the     motor nerves responsible for facial expression and eye protection. The investigators propose     less extensive surgery which should be thorough enough to prevent tumor recurrence while     keeping the facial nerve out of risk.   "
128138|NCT01607853|"     The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied     then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20     minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24     hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ     Dumas and JR Scholtz.   "
128139|NCT01607840|"     This research is being done to determine whether transcranial direct current stimulation     (tDCS) can improve certain mental abilities and alter functional connectivity in individuals     with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak     electrical current to the surface of the scalp while participants complete cognitive tasks.     Participants also receive a brain scan before and after stimulation. Our aim is to determine     if tDCS can improve mental abilities in individuals with schizophrenia.   "
128140|NCT01607827|"     The investigators aim to assess the procedure time and miss rate of polyps when performing     polypectomy in the colon on the way up* and down** or only on the way down**.      (* advancing the scope to the cecum, ** pulling back the scope after intubation of the     cecum). Our hypothesis is that using the strategy to remove all visible polyps firstly on the     way up and secondly on the way down is less time consuming and misses less polyps as with the     strategy to remove polyps only on the way down.   "
128141|NCT01607814|"     Patients with cirrhosis can have abnormalities in laboratory tests reflecting changes in     primary and secondary haemostasis.      Such changes have been considered particularly relevant in the bleeding complications that     occur in cirrhosis.      However, several studies have shown that routine diagnostic tests are not clinically useful     to stratify bleeding risk in patients with cirrhosis. Moreover, treatments used to increase     platelet count or to modulate platelet function could potentially do harm. Consequently the     optimal management of bleeding complications is still a matter of discussion.      Moreover, in the last two decades there has been an increased recognition that not only     bleeding but also thrombosis complicates the clinical course of cirrhosis. Over the last     years, emerge that in vivo platelet function and coagulation cascade might be modulated by an     alteration of pro-oxidant and antioxidant balance. Thus It has previously been demonstrated     that chronic liver diseases are characterized by increased oxidative stress state.      Aim of the study is to analyse the relationship between oxidative stress, haemostatic balance     and clinical complications in cirrhosis.   "
128142|NCT01607801|"     background Operation for small umbilical hernias is one of the most common surgical     procedures, but the best surgical technique, including the choice of suture or mesh remains     unknown.      It is well known that using non-absorbable sutures in closure of the abdomen, diminishes the     risk of incisional hernias and wound healing problems.It has also been found that the use of     resorbable suture in fixation of the mesh in Lichtesteins procedure leads to greater risk of     recurrence of the hernia. Furthermore, it has been stated in smaller studies, that the use of     the mesh in open operation for a small umbilical hernia has lower risk of recurrence (approx.     1-3%) than sutured repair (10-12 %). However, the scientific literature is deficient, with     few patients.      The purpose of this study is to describe reoperation rate of recurrence after small umbilical     hernias, depending on choice of sutures in both regular repair and in mesh repair.      Hypothesis: sutured repair with non-absorbable suture has lower recurrence rates than with     other types of sutures, whereas mesh repair has even lower recurrence rates in small     umbilical hernia repairs.   "
128143|NCT01607788|"     The investigators propose a prospective, web-based database (developed within the framework     of Quickbase, Intuit) which will allow an evaluation of the data for patients with a liver     tumour who receive a liver transplant. Each site will continue to transplant according to     their own criteria for inclusion on the waiting list. Each center will be responsible to     enter a short list of data points at time of listing, transplant, and at 1 and 2 years post     transplant. Data will be gathered prospectively through a web-based anaonymized database, and     outcomes analyzed yearly X5 for tumour recurrence and patient survival.   "
128144|NCT01607775|"     Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate     cage was designed and prospectively implanted in patients with a mono- or bilevel cervical     pathology. As control, a commercially available PEEK-cage was used, patients were randomized     using minimization randomization, controlling for age and bone mineral densitiy. The     investigators hypothesize that the newly developed cage has similar clinical and radiological     qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.   "
128145|NCT01607762|"     The purpose of this study is to compare capillary (the smallest of a body's blood vessels)     and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single     oral, immediate-release dose to healthy participants.   "
128146|NCT01607749|"     Undertake a study of educational intervention in primary schools in Andalusia      HYPOTHESIS:      There are differences in quality of life associated with asthma (as measured by the     questionnaire PAQLQ) and the level of asthma control in students with asthma aged 11 and 12     years who receive an educational intervention with their peers without asthma versus those     receiving standard information in schools.      OBJECTIVES: To compare the control of asthma symptoms, quality of life in asthma and asthma     knowledge among a group receiving an educational intervention delivered by specialist     teachers of physical education (MEEF) in Primary Schools (CEIP) and control.      MÉTODOS group: Randomized controlled single-blind.      POPULATION: Students of 11 and 12 years old in Andalusia      Sample size: 258 children / children with asthma for a mean contrast (alpha error of 3.4%.     80% power, a confidence level of 95% considering 20% loss. 2580 students will be enrolled     prevalence of asthma 10%) . Conglomerates of the CEIP in urban, rural, public and     private-reached.      INTERVENTION: Training MEEF with the educational program Sports and Health Asthma and     subsequent delivery, then the students MEEF are 5th and 6th grade ( 3 sessions). CONTROL: The     standard instruction in schools. OUTCOME VARIABLES: Quality of life (Juniper) and control     del asthma en niños(CAN) in asthmatics, Knowledge (NAKQ questionnaire) and attitudes toward     asthma (all students and teachers). Pre-intervention (T0), post-intervention at 5-6 months     (T1)      Independent variables: Sex, suffering or not asthma, intervention / control, type CEIP.      STATISTICAL ANALYSIS: Comparison of continuous variables: T Students (If normal distribution)     Mann-Whitney (If non-normal distribution). To study qualitative variables chi-square test     (normal distribution) and Kruskal-Wallis ( no-normal distribution).   "
128147|NCT01607736|"     Older individuals suffer from falls and fear of falling. The purpose of this study was to     determine the effectiveness of a novel virtual gait training on walking performance and fear     of falling in older adults, and to evaluate the feasibility of the virtual gait training     program. The investigators hypothesize that virtual gait training in older adults over a     three week period will both improve gait parameters as measured by a GAITRite® electronic     walkway system, and reduce their fear of falling as measured by the Falls Efficacy     Scale-International version.   "
128148|NCT01607723|"     Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +)     are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the     electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of     this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies,     and sleep pattern between NAVA and PAV+.   "
128149|NCT01607710|"     The investigators are seeking to locate the brain regions of interest in generalized anxiety     disorder (GAD) using both structural (sMRI) and functional magnetic resonance imaging (fMRI).     The MRI will be used to measure changes in blood flow in the brain while at rest and while     completing tasks designed to elicit symptoms of anxiety. Results from a nonclinical control     group and a GAD group will be compared to determine whether they exhibit different areas of     brain activity during the tasks.   "
128150|NCT01607697|"     Scientific Abstract:      The investigators propose a study to examine the impact of a Mindfulness Based Intervention     (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's disease     (PD).      NMS add significantly to the disease burden and negatively impact the quality of life in PD     (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD     patients with either early- or late-onset of disease (3). Despite currently available     treatments, PD leads to worsening disability and there remains a need for new approaches. A     Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of     PD in relation to NMS and quality of life.      A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU)     groups. Clinical assessments (motor and non-motor scores) will be performed in both groups.     The TAU group will be offered MBI after completion of the study.      To the best of our knowledge, this is the first large scale study using MBI in this     indication.   "
128151|NCT01607684|"     The purpose of this study is to determine whether Magnetic Marker Monitoring is an     appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects     with diabetic polyneuropathy.   "
128152|NCT01607671|"     The purpose of this study is to evaluate the feasibility of rapid evaluation and     administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior     ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the     progression or improves recovery of patients who are randomly assigned to treatment versus     standard of care.   "
128153|NCT01607658|"     The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2     intranasal testosterone gel to placebo on the occurrence of orgasm.   "
128154|NCT01607645|"     The goals of this study are to learn about the effectiveness, the side-effects, if waiting to     give the idarubicin and cytarabine may change the side effects or effectiveness, and to     identify factors to predict for responses to this therapy. The trial will examine combination     of three chemotherapy drugs. These drugs are decitabine, idarubicin, and cytarabine.   "
128155|NCT01607632|"     A before and after study of veterans who took part in a 12-week loving-kindness meditation     course as an adjunct to their usual care for posttraumatic stress disorder.   "
128156|NCT01607619|"     The investigators are studying a dietary supplement called anatabine in a lozenge form named     RCP006. The main purpose of this study is to evaluate the effects of this dietary supplement     on normal human inflammatory function. The investigators will see this effect in volunteers     who have markers of higher levels of inflammation to begin with. The investigators anticipate     that anatabine will reduce markers of inflammation. Therefore the investigators are looking     for volunteers with high blood levels of C-reactive Protein (CRP) and will monitor the blood     CRP levels at several time points throughout the study.   "
128157|NCT01606566|"     The purpose of this study is to evaluate the efficacy and safety of PC-A11 with superficial     and/or interstitial laser light application in patients with recurrent SCCHN.   "
128158|NCT01606553|"     The purpose of this study is to determine whether a high intensity short duration inspiratory     muscle training is feasible, secure and effective to improve respiratory muscle function     (strength and resistance), health-related quality of life, and to assess potential     correlations with health resources utilization.   "
128159|NCT01606540|"     It is believed that some painkillers (NSAID drugs) slow bone healing but the knowledge is     based only on experimental studies with animals whose results are automatically translated     for humans. The purpose is to examine whether these drugs slow bone healing and what     relationship there is between different bone examinations, scan for osteoporosis, bone marker     laboratory tests, radiological controls and histology of newly formed bone under a     microscope.   "
128160|NCT01606527|"     The proposed study is a prospective, randomized, double-blind, placebo-controlled clinical     trial evaluating ibuprofen and placebo for the prevention of neurological forms of altitude     illness [including high altitude headache (HAH), acute mountain sickness (AMS), high altitude     cerebral edema (HACE), and an emerging concept of High Altitude Anxiety]. The study will take     place in the spring and summer of 2012 at the Marine Corps Mountain Warfare Training Center     in the Eastern Sierras near Bridgeport, California. US Marines from near sea level will     participate in battalion-level training exercises at between 8,500-11,500 Feet, where some     altitude illness is expected. Concurrent measures used to determine objective markers of     altitude illness, such that validated clinical scales, rapid cognitive screening tests, will     inform us of symptoms of altitude illness.   "
128203|NCT01607060|"     MAIN FEATURES OF THE STUDY: therapeutic intervention. Constipation is a frequent complication     in critical ill patients. The disaccharide lactulose has a laxative osmotic activity. Given     the scant evidence and the potential risk associated with constipation in seriously ill     patients, this study aims to assess the impact of laxative therapy in the prognosis of     critically ill patients.      Study hypothesis: Constipation is part of the clinical spectrum of intestinal dysfunction and     if treated can result in improved prognosis for critically ill patients.   "
128161|NCT01606514|"     A single disaster, terrorist attack, or other large-scale incident can adversely affect     thousands of youth and families. Immediate consequences may include unmet basic needs and     high economic burden, particularly among underserved populations. Disasters also can     dramatically affect family roles and relationships over time (e.g., family routines, marital     stress, parent-child interactions). Whereas most youth are resilient in the aftermath of     disasters (i.e., do not develop serious mental health or health-risk problems), the     prevalence of various problems of public health significance (e.g., PTSD, depression,     substance abuse) clearly increases in this population. This underscores the need for     effective, widely accessible, culturally-appropriate and cost-efficient interventions that     foster resilience or rapid recovery relative to the health effects of disasters. Yet, few     evidence-informed resources are available to youth and families to facilitate post-disaster     resilience and recovery. Primary aims of this project are: (a) to develop a Web-based     intervention for disaster-affected adolescents and parents targeting prevalent health-related     correlates of disasters (i.e., development phase), (b) to conduct a randomized controlled     population-based study to examine feasibility and preliminary efficacy of the intervention     (i.e., randomized controlled trial [RCT] phase) and cultural relevance (i.e., perceived     applicability of the intervention to one's cultural group), and (c) to refine the     intervention based on RCT-phase data.   "
128162|NCT01606501|"     The primary aim this prospective longitudinal observational outcomes study is to compare 18     month functional outcomes and health related quality of life (HRQoL) of patients undergoing     salvage versus amputation following severe distal tibia, ankle and/or foot fractures with     major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL     will be measured using well established self reported measures, including the Veterans Rand     Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).      Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot     injuries with major soft tissue, bone and/or ankle articular surface loss will have similar     functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of     injury).      Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that     requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or     (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL had     they undergone a transtibial amputation (within 6 weeks of injury).   "
128163|NCT01607593|"     This is a multicenter retrospective study to investigate the dosage regimens of sertraline in     the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and the     efficacy and safety of this drug in patients with PTSD. Data will be collected from the     medical records of patients with PTSD.   "
128164|NCT01607580|"     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,     option for the treatment of leukemia. However, GVHD rate was still high after haploidentical     HSCT.      It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft     was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).      The study hypothesis:      Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after     unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of     acute GVHD   "
128165|NCT01607554|"     Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs and     other agents. There is a factor called ISG15 which might help doctors better identify     patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive     to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases.     Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in     cell growth, and it has been FDA approved for 17 years for another type of cancer.   "
128166|NCT01607541|"     Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all     adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment     delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly     less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience     serious barriers to entering care compared to other groups. The investigators research team     has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral     Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR     in NYC, and only 6% of these infections had been previously diagnosed. Further, in central     Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to     target HHR in central Brooklyn.      The primary goal of the proposed study is to evaluate the efficacy of a peer-driven     intervention (PDI) to seek, test, treat and retain HHR. The investigators will also compare     the effectiveness of two sampling methods to reach HHR: Respondent-driven sampling (a     peer-based approach) versus venue-based sampling (a location-based approach).      The two main study hypotheses are:      (H1): Participants recruited by respondent-driven sampling (RDS) will be more likely to test     positive for HIV compared to those recruited via venue-based sampling (VBS).      H2): Participants in the Test and Treat: phase of the peer-driven intervention (all of whom     will be HIV-infected) will show a shorter time to an HIV clinical appointment, a shorter time     to starting HIV medication (when medically indicated), higher rates of viral load     suppression, and higher rates of retention in care compared to those in the control arm.   "
128167|NCT01607528|"     Liver cirrhosis is the 10th most common cause of death in the western world. Infection is the     most common precipitant of deterioration of liver function in cirrhosis. Endotoxin, derived     from gram-negative organisms in the gut, can enter the circulation due to increased gut     permeability and contributes to neutrophil dysfunction, infection risk and mortality in     alcoholic cirrhotics. As probiotics decrease gram-negative organisms in the gut and/or     decrease gut permeability, the investigators hypothesize that probiotic treatment would     restore neutrophil function and prevent infection in alcoholic cirrhosis.      The investigators hypothesize that administration of a probiotic mixture in patients with     liver cirrhosis will improve innate immune function through alteration of the gut bacterial     flora and gut barrier integrity.      The aim of this randomised, double-blinded placebo-controlled study is to assess whether food     supplementation with probiotic mixture improves neutrophil phagocytic capacity in patients     with cirrhosis and decreases the incidence of significant infections.      92 patients with alcoholic cirrhosis will be included according to a sample size calculation     from preliminary data. Patients will be randomized in two groups: Group 1 receives a     probiotic mixture Group 2 receives a similar looking and tasting placebo without bacteria.     The recruited patients will be treated for 6 months. Besides routine clinical and laboratory     assessments, neutrophil function, toll-like receptor expression, endotoxin levels, bacterial     DNA, cytokine levels, albumin oxidation, gut permeability and analysis of gut microflora will     be performed. Furthermore nutritional status and quality of life will be assessed.      Primary endpoints will be neutrophil phagocytosis. Secondary endpoints will be significant     infection, neutrophil oxidative burst, neutrophil toll-like receptor expression, endotoxin     levels, bacterial DNA; cytokine levels, albumin oxidation, gut barrier function and bacterial     flora, nutritional status and quality of life.      If our hypothesis holds true, probiotics will provide an easily applicable and cost effective     method to improve immune function and to prevent infection in liver cirrhosis. It is possible     that this can improve survival of patients with liver cirrhosis.   "
128168|NCT01607515|"     Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25     mmHg in the right heart catheterization.      There are different forms of PH defined in the classification of Dana Point 2008.      PH is diagnosed with right heart catheterization but there are other non invasive methods     which can be used for screening like echocardiography, stress echocardiography and cardio     pulmonary exercise testing.      For prognosis of PH patients the limitation of the pulmonary circulation is very important.     Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The     gold standard for CI measures is the thermodilution, an invasive method performed during     right heart catheterization.   "
128169|NCT01607502|"     Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25     mmHg measured in the right heart catheterization.      There are different forms of PH defined in the classification of Dana Point 2008.      PH is diagnosed with right heart catheterization but there are other non invasive methods     which can be used for screening like the echocardiography, stress echocardiography and cardio     pulmonary exercise testing. In the diagnosis process and in the follow up of PH patients     biomarkers like NTproBNP are helpful. There are no specific biomarkers for the disease which     can make the diagnosis process easier and predict prognosis.      The systematic data collection in a data base provides better information about patients in     daily routine and clinical studies as well as in the design of new studies.   "
128170|NCT01607489|"     The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of     pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In     this pilot study the investigators investigate patients who underwent right heart     catheterisation with DE-CT to determine hemodynamic parameters and control the results by     other clinical investigations. The investigators expect that using this non-invasive method,     parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume,     blood flow and perfusion heterogeneity, can be determined.   "
128171|NCT01607476|"     The intent of this research protocol is to test the equivalency of two amyloid imaging drugs     (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there     will be no significant difference in the distribution of the agents to areas of amyloid     deposition in the brain or to other normal brain structures. Recent data have shown     similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild     cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has     been published. It is important to understand differences in the images and biodistribution     from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain     structures such as white matter appear to differ slightly and could affect image performance.   "
128172|NCT01607463|"     The purpose of this study was to investigate whether transcutaneous electrical nerve     stimulation (TENS) could reduce pain during cannulation of vein.   "
128173|NCT01607450|"     The objective of this proposal is to provide quantitative dose-response data for effects of     GLP-1 on myocardial glucose uptake in healthy control subjects and obese type 2 diabetic     subjects, in support of the design of later studies evaluating therapeutic applications of     GLP-1 to heart disease.      Aim 1: To measure the effects of GLP-1 infusion on myocardial fuel selection in lean healthy     humans under fasting (fatty acid-dominant) conditions. Four groups of 10 lean healthy     subjects will be studied during infusions of 0 (saline control), 0.5, 1.5, and 4.0     pmol/kg/min GLP-1 (one study per subject). Cardiac metabolism will be measured using PET,     using a dual-tracer approach which allows measurement of myocardial glucose uptake (the     primary endpoint) along with total oxidation rate and myocardial perfusion (secondary     endpoints). In concert with measures of circulating metabolites and regulatory hormones, the     investigators will produce the most comprehensive assessment of actions of GLP-1 on     myocardial metabolism in humans to date. Effects of each dose will be compared to the saline     control, plus the investigators will combine all data and use nonlinear curve-fitting to     derive sensitivity (ED50) and maximal responses for GLP-1 effects on myocardial glucose     uptake.      Aim 2: To measure the effects of GLP-1 infusion on myocardial fuel selection in obese type 2     diabetic humans under fasting (fatty acid-dominant) conditions Four groups of 10 obese type 2     diabetic subjects will be studied during infusions of 0, 0.5, 1.5, and 4.0 pmol/kg/min GLP-1     as under Aim 1. Analyses will be parallel to those described under Aim 1. Results from Aims 1     and 2 will be combined to allow direct comparison of the dose-response between nondiabetic     control and type 2 diabetic subjects.      No literature has been published to inform dose selection in the design of clinical trials of     GLP-1 for modulation of heart fuel selection. With our expertise and experience in PET     measurement of heart metabolism in diabetes, the investigators are uniquely positioned to     fill this gap in knowledge. These studies are a necessary preamble to further evaluation of     the potential for GLP-1 based treatments in heart disease.   "
128174|NCT01607437|"     No former studies have done long-term evaluation on patients reconstructed with hamstrings     graft, the use of Howells tibial guide and transtibial drilling of the femoral graft tunnel.     The investigators aim to evaluate clinical, radiographic and subjective outcome at a minimum     of 10 years after surgery. According to former published studies on alike methods, the use of     transtibial drilling of the femoral graft tunnel causes an increased rotational instability     of the knee. The investigators aim to map the clinical stability of this group as well as     evaluating the general outcome at the long-time horizon.   "
128175|NCT01607424|"     Rationale:      Cognitive deficits are a core feature in schizophrenia. Conventional treatments     (antipsychotic medication and psychological treatments) have limited effects so cognitive     remediation programs were designed to alleviate the problems. Interventions typically involve     a variety of exercises in a paper and pencil or a computerized format with a growing number     of specialized computer programs now being developed. However, many of these programs lack     specificity which does not allow an individual's specific needs to be addressed. More     targeted interventions might increase the effects of therapy so RECOS - COgnitive REmediation     for Schizophrenia - was developed to fit this gap.      Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to 45     years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an     already validated program (CRT).      220 patients will be randomized as follows :        -  Arm 1 : RECOS (42 h)        -  Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris,          Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.   "
128176|NCT01607411|"     An in situ model will be used to evaluate and compare enamel remineralization of human enamel     specimens after single use of experimental children's toothpastes.   "
128177|NCT01607398|"     The study will be conducted in a respiratory specialist institute in Japan, with standardized     techniques and data assurance checks to optimize data quality. The licensed dosage and     administration of Adoair in Japan will be applied in this study. Each subject will receive     treatment options in a randomized blinded fashion. Subjects will be randomized following a     4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for     12 weeks.   "
128178|NCT01607385|"     A single blind, randomized, placebo-controlled, dose escalating study to evaluate the safety,     tolerability, pharmacokinetic and pharmacodynamic parameters of repeat doses of GSK2330672 in     healthy volunteers, given alone and with a single day of dosing with GSK1614235   "
128179|NCT01607372|"     GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates     preferentially the induction of type I interferons. Intranasal (i.n.) administration of     GSK2245035 in humans causes immune changes in the upper airways milieu that may alter     bystander immune responsiveness to aeroallergens and contribute to reduction of allergic     reactivity in subjects with respiratory allergies. The purpose of this study is to examine     the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with     respiratory allergies. The safety and pharmacodynamic response of four weekly administrations     of escalating doses of i.n. GSK2245035 will be investigated and the maximum tolerated dose     will be established. The study will be conducted in patients with symptomatic allergic     rhinitis and mild asthma. The overall duration of the study will be up to a maximum of     approximately 122 days considering 90 days screening period, 22 days treatment period and 10     days follow-up period.   "
128180|NCT01607359|"     Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter     ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with     warfarin are well established, the relative risk and benefit of dabigatran in this setting     are unknown. The purposes of the study are to assess the efficacy of warfarin versus     dabigatran in the prevention of stroke and other systemic embolic complications before and     after catheter ablation for AF, and to compare the prevalence of serious bleeding     complications with the two OAC agents.   "
128181|NCT01607346|"     This is a multicentre, open label study to examine the effect of ezogabine/retigabine on the     voiding function of adult subjects with drug-resistant partial onset seizures (POS). Subjects     fulfilling the study entry criteria at Screening and at Baseline including a comprehensive     eye examination by an ophthalmologist or retina specialist and a skin assessment by the     investigator will receive ezogabine/retigabine.      The starting dose of ezogabine/retigabine will be 300 mg/day. Subjects will be up titrated by     150 mg/day weekly up to the maximum ezogabine/retigabine daily dose of 1200 mg (or the     highest tolerated dose). During the 49 days of the treatment phase, subjects will undergo     three repeat non-invasive assessments of voiding function. In addition, subjects who meet     pre-determined criteria for voiding dysfunction will undergo multichannel cystometry in order     to characterise bladder hypocontractility, bladder outlet obstruction or a combination of     events which clinically is manifest with difficulty emptying the bladder or acute urinary     retention.      At the end of the Treatment Phase, all subjects will enter the Taper Phase, a 3-week down     titration period. Subjects who have new findings of abnormal pigmentation of the retina,     unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin,     lip, nail, or mucosa since baseline will be asked to enter the Safety Follow-Up /     Continuation Phase. All subjects will undergo 6-monthly comprehensive eye examinations during     the Safety Follow-Up / Continuation Phase. Subjects who have not developed abnormal     discoloration of the skin, lips, nails or mucosa will continue to undergo skin assessments by     the investigator. Any subject who has developed abnormal discoloration of the skin, lips,     nails or mucosa since baseline will be referred to a dermatologist for evaluation and     6-monthly follow up assessments. All subjects will continue to be followed until the     pigmentation and/or discoloration has resolved or stabilised, as defined by no change over 2     consecutive 6-monthly assessments conducted over at least 12 months after discontinuation of     ezogabine/retigabine.   "
128182|NCT01607333|"     The studies described in this protocol are all performed within the framework of PROTECT     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and     disseminate methodological standards for the design, conduct and analysis of     Pharmacoepidemiological (PE) studies applicable to different safety issues and using     different data sources. To achieve this, results from PE studies on five key adverse events     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the     methodological aspects of the studies in this protocol and not on the clinical consequences     of the association under investigation.      In the present project, investigators use Columbia Classification Algorithm of suicide     assessment (C-CASA) definitions as a basis to specify the operational definitions of the     different aspects of suicidality. The focus of the main analyses is on attempted suicide     including completed suicide. This is due to statistical power issues. However, investigators     will apply two additional outcome definitions in sensitivity analyses: 1) completed suicide     only and 2) completed suicide, suicide attempt, preparatory acts toward imminent suicidal     behavior, suicidal ideation plus indeterminate or potentially suicidal events. Investigators     will not include terms which clearly indicate an accidental event, or self-injurious behavior     without a suicidal intent. These definitions are listed in the statistical analysis plan     together with lists of terms from the dictionaries used in the different databases.      The objectives of this study are to 1) Compare the study results which are based on two data     sources (he UK General Practice Research Database (GPRD) and Danish registries) and different     designs and evaluate the impact of design and population differences on the outcome of the     study results (the UK database 'The Health Improvement Network' (THIN) may be included in     these analyses as well); 2) Evaluate the strengths and weaknesses of the two data sources to     study a possible association of antiepileptic drug (AED) use and suicidality, in particular     the specific outcomes of death from suicide, hospitalization due to suicide attempt, and     reports of the aspects of suicidality by the patients; 3) Estimate risks of completed     suicide, completed suicide and attempted suicide, and completed suicide, suicide attempt,     preparatory acts toward imminent suicidal behavior, suicidal ideation plus indeterminate or     potentially suicidal events overall for all AEDs and by individual AEDs prescribed in UK and     Denmark; and 4) Describe the patterns of AED prescribing in six European databases (GPRD and     THIN, UK; Danish registries; Mondriaan, Netherlands; Bavaria, Germany; Base de Datos para la     Investigación Farmacoepidemiologica en Atencion Primaria (BIFAP), Spain).   "
128183|NCT01607320|"     This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic     ovarian syndrome (PCOS).   "
128184|NCT01607307|"     A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese     herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the     prevention of postoperative paralytic ileus.   "
128185|NCT01607294|"     This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in     subjects with type 2 diabetes.   "
128186|NCT01607281|"     The study is designed to determine anaesthetists ability to locate the right internal jugular     vein(IJV) and left IJV using a landmark technique. Initially, a questionnaire was completed     detecting previous user experience. An ultrasound probe, using the midpoint as an 'imaginary     needle', was placed on the neck of a healthy volunteer and the image recorded. Both     anaesthetist and volunteer were blinded to the screen until the image was stored.     Anaesthetists were grouped into senior or junior by the total number of IJV canulation     experience. The success rate is going to be measured as pass or fail.   "
128187|NCT01607268|"     This research study will be conducted in patients with primary autonomic failure, a disabling     condition that is associated with low blood pressure upon standing. These patients are also     not able to control for changes in their blood pressure due to a loss of cardiovascular     reflexes that are mediated within the brain. The purpose of this study is to determine     whether magnetic resonance spectroscopy (MRS), a non-invasive imaging technique, can measure     levels of chemicals (neurotransmitters) in the dorsal medulla, a brain area important for     control of cardiovascular function, in autonomic failure patients. Importantly, this study     will determine whether there are differences in brain chemicals between patients with     peripheral versus central origins of their autonomic failure. The hypothesis is that the     neurotransmitter profile in the medulla will be intact in patients with peripheral autonomic     failure compared to those with central impairment. Overall, this study will provide insight     into understanding the mechanisms involved in autonomic failure and will determine whether a     single session of MRS imaging can improve the ability to make an accurate diagnosis in these     patients. This would lessen the need for more extensive and invasive clinical testing.   "
128188|NCT01607255|"     Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal     cancer screening. Population studies have shown that traditional air colonoscopy fails to     eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The     investigators aim to establish the superior effectiveness of combining chromoendoscopy with     the water exchange method in detecting more proximal diminutive adenomas during screening     colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical     colonoscopy will minimize the risk of missed lesions. The improvement may translate into a     remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher     adenoma detection rate may minimize the burden of post screening colonoscopy interval     colorectal cancers among the veteran population.   "
128189|NCT01607242|"     Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and     swallowing function.   "
128190|NCT01607229|"     SPECIFIC AIM:      Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium     water (D2O) measurements.      HYPOTHESIS:      The Biospace Body Composition Analyzers are valid tools for measuring total body water and     body composition.   "
128191|NCT01607216|"     This is an observational study that proposes to collect clinical, physiological, cellular and     molecular information in an attempt to identify a set of factors that may predict the risk     for persistent lung disease in babies born prematurely.   "
128192|NCT01607203|"     The purpose of this study is to see whether patients triggered with only human Chorion     Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate     than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.   "
128193|NCT01607190|"     The purpose of this study is to validate a predictive model of diabetic retinopathy     progression in patients with diabetes mellitus type 2 patients to clinically significant     macular edema (CSME) needing treatment either photocoagulation or intravitreal injections     (ITV) using non-invasive techniques.   "
128194|NCT01607177|"     Preoperative exercise has been shown to improve physiological and functional capacity in     patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients     undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the     setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is     also thought to increase the likelihood that they will exercise postoperatively. However,     compliance to this advice is extremely low. Text-message interventions have been shown to     improve compliance to other lifestyle interventions. The investigators will compare the rate     of compliance to preoperative exercise prior to bariatric surgery in patients who receive a     daily text message to those who do not. The investigators will also compare weight loss.   "
128195|NCT01607164|"     This study is pilot testing a self-help automated Website (similar to a self-help book)     designed to help individuals to learn methods to manage their mood. The methods are     cognitive-behavioral skills found effective in the treatment of depression when provided by     live therapists. The purpose of the study is to determine the number of individuals who will     visit the site, use the site, and respond to online surveys reporting their mood levels while     using the site, and at 1, 3, and 6 months after starting to use the site. The investigators     want to eventually examine whether learning these methods online would help prevent     depression.   "
128196|NCT01607151|"     Though TTM is ubiquitously used in the neuro-intensive care unit, there is limited experience     with the use of TTM after intracerebral hemorrhage (ICH), the most devastating type of     stroke. TTM may be a an intervention to improve patient outcomes. This trial addresses the     safety and tolerability of a protocol of ultra-early TTM after ICH/IPH and may be the basis     for future larger clinical trials.   "
128197|NCT01607138|"     Swallowing and speech difficulties will be observed in patients post laryngectomy. These     difficulties will cause decreased in quality of life.   "
128198|NCT01607125|"     The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in     neural activity (BOLD signal), as measured using fMRI, in brain areas associated with     executive functioning and memory during cognitive task performances compared to placebo in     subjects remitted from depression and in controls, and to explore if Vortioxetine will lead     to improved cognitive performance in the absence of depression.   "
128199|NCT01607112|"     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'     trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in     adults (18 to 60 years) and in elderly (over 60 years).   "
128200|NCT01607099|"     For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol)     has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of     macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the     examination). One handicap of using polyethylene glycol is the occurence of nausea and     vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a     pilot study the investigators have detected a high fraction of patients who consider the     cleansing procedure wich macrogol as very distressing. Thus patient acceptance of the     colonoscopy procedure altogether is low.      Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in     Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium     picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are     instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study     the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much     more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness     of the bowel was equal in both groups.      The investigators believe that a new protocol which contains sodium picosulfate/magnesium     citrate instead of macrogol will benefit the patients by fewer abdominal side effects while     cleanness of the bowel at the same time will be warranted. This presumption is the reason for     the present study.   "
128201|NCT01607086|"     The objective of this sensory analysis study is to determine whether volunteers observe a     significant difference in organoleptic properties between lamotrigine (430C78) cherry     flavoured orally disintegrating tablets (ODT) and a placebo cherry flavoured orally     disintegrating tablet. The aim is to assess the value of the placebo as a marketing aid,     whereby physicians and patients may assess the personal acceptability of the organoleptic     properties and potential convenience prior to prescription of the ODT formulation.   "
128204|NCT01607047|"     Leptospirosis is a zoonosis of worldwide distribution whose incidence is higher in the     tropics, where conditions for transmissions are favorable. The disease is endemic in     Martinique and Guadeloupe, two Caribbean islands of the French West Indies. In tropical     areas, many wild and domestic animals serve as reservoirs for pathogenic Leptospira strains     and contaminate the environment by shedding the organisms in their urine. Humans are usually     infected through abraded skin or mucous membrane contact with water contaminated by the urine     of animal reservoirs, and less frequently by direct contact with animals or their urine. The     mean incubation period is 10 days, with a usual range of 2-20 days. Clinical manifestations     are protean and the spectrum of symptoms range from subclinical or mild anicteric febrile     illness to acute renal failure and respiratory distress syndrome which are associated with     high mortality rates.      The microscopic agglutination test (MAT) and culture are the reference standard test for     diagnosis of leptospirosis, but they are only available in reference laboratories and their     conclusive results requires convalescent sample or prolonged incubation. At present, only     direct detection methods using PCR might provide rapid diagnosis during the early acute stage     of the illness, when treatment is likely to have the greatest benefit.      Quantitative PCR also offers the ability to measure level of leptospiremia in clinical     samples. Using qPCR based diagnosis, the investigators have the opportunity to study the     association of level of leptospiremia and clinical manifestations in French West Indies. All     qPCR-positive samples will be used for molecular typing.   "
128205|NCT01607034|"     To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in     intact tablet form in the fasted and fed states in healthy volunteers.   "
128206|NCT01607021|"     The aim of this study is to investigate the relationships between interleukin 28B genetic     variants and the response to treatment of chronic hepatitis C in Chinese children.   "
128207|NCT01607008|"     Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External beam     radiation therapy is one of the common methods to treat prostate cancer. Although     radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic     ratio. Those side effects are usually associated with the radiation damage of the normal     tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and the     side effects of radiation treatment are often accessed after whole course of radiotherapy,     which makes the early intervention difficult. The current research project is a feasibility     study of utilizing advanced magnetic resonance imaging (MRI) techniques to access     radiotherapy treatment response of prostate cancer during and right after radiotherapy.      Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic     contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments     for diagnostic purpose. This research project is to study the feasibility of using advanced     MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes     revealed from MRI can provide physicians early information on possible tumor recurrence and     normal tissue toxicity, therefore, the early intervention may be possible to spare normal     tissue and cure the patient. The project is designed to combine several different advanced     MRI imaging techniques systematically to study tissue changes during radiotherapy, which has     not been seen elsewhere to date.      Another important goal of this research project is to study the feasibility of associating     functional MRI with radiation treatment dose distribution. Tissue response during radiation     treatment depends on dose. The functional MRI can provide more information than simple     anatomic information. Mapping the functional MRI spatially and associating them with 3D dose     distribution in radiation treatment planning system is one important step to quantitative     assess the relationship between radiation treatment and tissue changes due to the radiation.   "
128208|NCT01606995|"     This is an international observational study in patients with non-valvular atrial     fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent     stroke or non-central nervous system systemic embolism.   "
128209|NCT01606982|"     The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor     its safety in patients with metastatic castration-resistant prostate cancer previously     treated with docetaxel-based chemotherapy.   "
128210|NCT01606969|"     Scalp infiltration with Epinephrine- containing lidocaine solution is common method for     craniotomy but it may result in transient but significant hypotension in patients undergoing     neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently     reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine     response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus     theologically appropriate for reducing bleeding during scalp incision in craniotomy.      The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on     hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.   "
128211|NCT01606956|"     Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion     in adult patients. However, it is not proven how much the cuff should be inflated. The aim of     this study is to compare efficacy between the method using the resting volume and the method     using half the maximum volume for partial cuff inflation.   "
128212|NCT01606943|"     Clinical profiles and outcomes of patients with acute aortic dissection have not yet been     evaluated in China. The aim of this study is to establish clinical registry of acute aortic     dissection in China and to analyze clinical features, managements and outcomes of Chinese     patients with acute aortic dissection.   "
128213|NCT01606930|"     The purpose of this controlled pilot study is to determine whether an intervention aimed at     patients will improve partnering, shared decision-making and open communication. Results from     this pilot study will inform how to best proceed with a larger multi-centered randomized     controlled trial.      The specific hypothesis for this pilot study is to:        1. Test the feasibility of a simple patient-centered intervention.        2. Test the correlation between patient readiness to actively engage in conversation          (assessed using a pre-visit patient survey) and actual patient behaviors in the          encounter.        3. Develop a coding tool that will quantify patient activation in clinical encounters.        4. Test whether activating patients who are more involved and revealing in the          patient-clinician dyad will improve patient and clinician outcomes.   "
128214|NCT01606917|"     The purpose of this study is to examine the effects of a weight reduction program in adults,     seen in a primary care setting, with overweight/obesity perceived as a health problem or with     diseases related to overweight/obesity and ambitions to achieve weight reduction as part of     treatment.   "
128215|NCT01606904|"     The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight     loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart     diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects     suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and     follow how they benefit from the program in order to achieve maintained weight loss. Also,     the associations between weight loss, physical activity and musculoskeletal disorders are     studied.   "
128216|NCT01606891|"     The goal of the Minnesota center is to integrate primary care, home, and community-based     intervention strategies to promote sustained patterns of change in food intake, physical     activity, and body weight among low income, ethnically diverse children. A culturally matched     family connector will create linkages among the settings to support parents in making home     environment and parenting behavior changes conducive to healthy growth and development in     their children.      Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted     randomized controlled intervention on the primary outcome, child BMI, compared to a standard     primary care-only intervention among 500 low income ethnic minority two to four year old     children who are at or above the 50th percentile of BMI for age and gender.      Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower     BMI at 24 and 36 months, compared with children in the standard primary care only control     group.      Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted     intervention on secondary outcomes, including change in child energy intake and physical     activity energy expenditure, compared to a standard primary care-only intervention.      Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower     energy intake and higher energy expenditure over the three-year period, compared with     children in the standard primary care-only control group.      Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on     hypothesized mediators of change in dietary intake, physical activity, and BMI.      Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and     physical activity environment will mediate changes in child energy intake and expenditure,     and body mass index.   "
128217|NCT01606878|"     This phase I trial studies the side effects and the best dose of crizotinib giving together     with combination chemotherapy in treating younger patients with relapsed or refractory solid     tumors or anaplastic large cell lymphoma. Crizotinib may stop the growth of tumor or cancer     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as cyclophosphamide, topotecan hydrochloride, dexrazoxane hydrochloride, doxorubicin     hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing   "
128218|NCT01606865|"     The aim of the study is to evaluate if there is an association between platelet inhibition     and surgery-related bleeding in patients undergoing non-cardiac surgery during dual     antiplatelet therapy.   "
128219|NCT01606852|"     Mechanical ventilation (MV) is the most frequently used life-support modality in intensive     care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently     administer a variety of sedative medications to their patients based on subjective     observations.      The investigators hypothesize that patient-controlled sedation, compared to     clinician-directed sedation, will decrease sedative exposure while decreasing patient anxiety     during the episode of mechanical ventilation.   "
128220|NCT01606839|"     The study hypothesis is that accuracy of CO measurement by IGR does not differ from classical     CO measurement methods such as thermodilution or direct Fick method. This is why the study     aims to determine whether non invasive cardiac output (CO) measurement using inert gas     rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order to     examine this, the IGR method will be used in patients undergoing diagnostic or follow-up     right heart catheterization.   "
128221|NCT01606826|"     The mission of the SARP is to improve the understanding of severe asthma through integrated     study of its clinical and biological features and to evaluate their changes over time. The     ultimate goal of these efforts is to promote better treatments for severe asthma.   "
128222|NCT01606813|"     The investigators will conduct a randomized controlled trial comparing the effects of three     interventions on weight loss at 12 months. The investigators propose to test the impact of     integrating an effective automated Internet weight control program into primary care by     recruiting patients and randomizing them to one of three conditions: A) Brief physician     counseling plus usual care, B) Brief physician counseling plus referral and access to the     Internet weight control program and, C) Brief physician counseling plus referral and access     to the Internet weight control program plus brief follow-up email notes of support and     accountability from Primary Care Physicians. The investigators hypothesize that an online     program for weight control can be more effective by enhancing online follow-up with PCPs.   "
128223|NCT01606800|"     The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks)     versus standard 48 week treatment in previously untreated adult participants with chronic     hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as     HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.   "
128224|NCT01606787|"     The purpose of this study is to determine if a medication called mannitol, can help the     kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in     urine production (it is a diuretic). For many years, mannitol has been given to patients in     the hope it would improve the kidney's circulation, and in doing so reduce the impact of the     surgery on the kidney.      Mannitol is given during the surgery before the blood supply to the kidney is stopped. The     blood supply to the kidney is stopped in order to minimize any blood loss during the removal     of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is     removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary     reduction in blood supply to the kidney is the loss of some kidney function. This may happen     either in the short term (right away) or long term (months or years later). In studies done     on animals, mannitol was able to lessen this damage to kidney function. However, no human     study has ever confirmed that mannitol has the same helpful effect in humans. There is some     suggestion that it may have no effect. Because sufficient research has yet to be done on     humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan     Kettering which looked back at patients who had undergone partial nephrectomies, an operation     where only the portion of the kidney that contains the tumor is removed and enables the     normal, unaffected portion of the kidney to be preserved. The results of this study     demonstrated no significant difference in kidney function when the investigators compared     patients who were given mannitol to those who were not. The investigators hope that this     study will help clarify the effectiveness or not of mannitol on kidney function. During the     surgery to remove the kidney tumor, patients will receive either mannitol or a placebo. A     placebo, is a harmless medication that has no effects. The impact of mannitol compared to the     placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after your     surgery.   "
128225|NCT01606774|"     The investigators plan to identify 80 pregnant women at low risk for obstetrical     complications and replace 4-5 routine third trimester visits with a structured program of     home weight, blood pressure and urine protein monitoring along with regular structured phone     interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is     both safe and acceptable.   "
128226|NCT01606761|"     The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction     of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are     unresponsive or intolerant to treatment with anti-TNF-alpha agents.   "
128227|NCT01606748|"     The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in     combination with gemcitabine-cisplatin in participants with advanced malignant solid tumors     and to assess the potential for drug-drug interactions between necitumumab and     gemcitabine-cisplatin.   "
128228|NCT01606735|"     This study will test the efficacy and safety of IBI-10090 in the treatment of ocular     inflammation after ocular surgery.   "
128229|NCT01606722|"     To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations     and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.   "
128230|NCT01606709|"     The purpose of this study is to compare gene expression profiles in endometrial biopsies     during the window of implantation after triggers of oocyte maturation using GnRH agonist or     hCG and compared with their natural cycles in order to identify genes that may be     dysregulated in GnRH agonist-triggered cycles.      The investigators also intend to evaluate patients feeling of well being and physical quality     of life after GnRH agonist trigger compared with hCG trigger   "
128231|NCT01606696|"     The purpose of this study is to compare the effect higher intensity interval exercise (HIIT)     with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients     with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.   "
128232|NCT01606683|"     The purpose of this study is the evaluation with untargeted modalities, of the urine     metabolomic profile in a group of infants fed with a standard formula, a group of infants fed     with a formula supplemented with functional ingredients and a group of breast-fed infants.   "
128233|NCT01606670|"     The primary objective of this study is to evaluate the perception of pain associated with     Parkinson´s Disease in patients who receive Neupro® for the first time.   "
128234|NCT01606657|"     In this study, the investigators are trying to find out if washing out the abscess (pocket of     pus) with fluid will help, instead of only taking out the pus. Your care will be the same as     usual, except that you will be selected randomly to have your abscess washed out with fluid,     or not.   "
128235|NCT01606644|"     Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue     injury to salivary gland tissue.   "
128236|NCT01606631|"     The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of     infectious diseases. They are one of the top ten causes of death in industrialized countries.     But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence     on a community infection has never been studied. The objective of this study is to evaluate     this role.   "
128237|NCT01606618|"     With improved life expectancy over the last fifty years, spina bifida has become a disease of     the adult. One of the major stakes for these patients is the preservation of a regular     follow-up of uro-nephrologicals risk factors and of a respect for the rules of self     management of their neurological bladder.      The main objective of this study is to highlight a difference in the level of global     self-esteem among a population of adult patients with spina bifida and a population of adult     patients with traumatic spinal cord injury gained the same level of neurological.   "
128238|NCT01606605|"     The investigators perform a retrospective microarray gene expression profiling study of FFPE     from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and     Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients     with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is     correlated with clinical outcomes of diffuse large B-cell lymphoma.   "
128239|NCT01606592|"     The efficacy of two forms of psychotherapy with panic disordered patients, a     cognitive-behavioral and a psychodynamic one, are compared under two different, randomized     conditions: randomization or self-selection. The basic hypotheses are that the efficacy of     both treatments is higher and that the efficacy difference is smaller under self-selection     than randomized conditions.   "
128240|NCT01606579|"     PRI-724 is a new investigational drug being studied to treat subjects with cancer who have     advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling     pathway that cancer cells need to grow and spread (metastasize).   "
128241|NCT01606488|"     Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients     greater than or equal to 65 years of age.      This study will test the hypothesis that preoperative presence of brain beta-amyloid plaques     in non-demented subjects increases postoperative cognitive decline (POCD) in elderly subjects     scheduled for hip or knee replacement.      The investigators hypothesize that preoperative beta-amyloid plaques will predict     postoperative cognitive decline.   "
128242|NCT01606475|"     The purpose of this study is to evaluate the safety and efficacy of islet transplants from     human cadaver donors into type 1 or surgical diabetes mellitus patients who experience     frequent acute or advanced chronic complications but do not qualify for other islet     transplant trials. Under this protocol, patients may receive intraportal alloislet transplant     under one of the following scenarios:        1. islet transplant alone        2. simultaneous islet-kidney transplant, or 3)islet after kidney transplant.   "
128243|NCT01606462|"     The purpose of this study is to determine whether oxytocin influences memory of social     stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of     oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social     stimuli.   "
128244|NCT01606449|"     Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can     achieve outcomes that afford the patient lifelong satisfaction. The published results     obtained with this surgery may not be considered to be definitive in relation to the length     of follow-up or patients' life expectancy. The real recurrence rates and the results of     surgery for GERD are difficult to assess due to the lack of serial time points during the     follow-up. Further bias may have been introduced into the analysis by a lack of appropriate     controls. The results of surgical therapy for type II-IV HH are even more controversial     because of the high rate of anatomical relapse and the different methods of follow-up adopted     in reported case series.      Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The     investigators report on patients who were followed up after surgery at various time points     over the course of 30 years.   "
128245|NCT01606436|"     This study will determine if a single dose of pomaglumetad methionil affects the electrical     activity in the heart in people with schizophrenia. This study will also help determine how a     single high dose of pomaglumetad methionil is tolerated by participants.   "
128246|NCT01606423|"     This is a study to measure the effect that various doses of LY2409021 have on blood sugar     levels and on the amount of glucose released by the liver, when glucagon is given to increase     these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study     periods, with a minimum 13-day washout between dosing periods. This study is approximately 9     weeks long, not including screening. A screening appointment is required within 6 weeks prior     to the start of the study.   "
128247|NCT01606410|"     Rationale: Ischaemic preconditioning (IP) refers to the reduction of ischemia-reperfusion     injury induced by a brief preceding period of ischemia. Also the arterial endothelium can be     protected by IP. Several studies performed in animals and humans have demonstrated that the     protective effects of IP are attenuated with aging. However, no previous study directly     examined the underlying mechanisms of this observation. Possibly, the reduced protective     effect of IP with aging relates to a direct effect on the endothelium, consequently leading     to an attenuated ability of IP to prevent endothelial dysfunction after ischaemia reperfusion     injury.      Several previous studies failed to demonstrate the ability of pharmacological stimuli to     mimic the beneficial effects of IP in aged vessels. Restoration of the age-related reduction     in effectiveness of IP may be possible through exercise training. In aged animals, physical     training restores the efficacy of ischemic preconditioning. Indirect evidence indicates that     physical activity, independent of other cardiovascular risk factors, protects against a     occurrence as well as the severity of a myocardial infarction in humans. Although this     suggests that physical activity may beneficially influence the age-related reduction in IP,     no previous study provided direct evidence for this hypothesis.      Objective: To examine the impact of age and physical fitness on the ability of ischaemic     preconditioning to protect endothelial damage in response to ischaemia reperfusion injury in     healthy humans. A secondary objective is to explore the role of Toll-like receptor (TLR)     signalling in the induction of IP in young and old subjects.   "
128248|NCT01606397|"     The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary     purpose of this study is to help answer the following research questions, and not to provide     treatment for diabetes :        -  The safety of LY2409021 and any side effects that might be associated with it following          4 weeks of doses        -  How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks        -  How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other          naturally occurring substances before and after a meal        -  How LY2409021 works when given with metformin        -  How daily dosing of LY2409021 affects the cells that produce insulin   "
128249|NCT01606384|"     Primary Objective:      - To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on     hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.      Secondary Objectives:        -  To evaluate the tolerability and safety of SSR149415 in patients with major depressive          disorder.        -  To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients          with major depressive disorder.        -  To evaluate plasma concentrations of SSR149415.   "
128250|NCT01606371|"     The main purpose of this study is to determine the safety of LY2409021 in healthy     participants and participants with diabetes. The study drug is given as single oral doses.     Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing     periods. Side effects will be documented. This study is approximately 9 weeks long, not     including screening. Screening is required within 6 weeks prior to the start of the study.   "
128251|NCT01606358|"     In patients with an ovarian cancer, the treatment is currently based on surgery and     chemotherapy.      The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T     cells has never been evaluated.      The long term goal is to give a rational to combine conventional treatment of ovarian cancer     with immunotherapy based on Vgamma9Vdelta2 T cells.   "
128252|NCT01606345|"     The purpose of this study is to learn more about how well the drug valrubicin (VALSTAR®)     works to help treat the patient's cancer when administered through a nephrostomy tube     inserted through their back into their kidney. The study is also being done to determine how     safe and easy it is to tolerate valrubicin at specific dose levels, as well as the way in     which the drug is eliminated from the human body (Pharmacokinetics or PK).   "
128253|NCT01606332|"     In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a     postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing     shoulder pain and improving range of motion compared to a single-dose interscalene block.   "
128254|NCT01606319|"     The Acetaminophen Versus Ibuprofen in Children with Asthma study will test the primary     hypothesis that in preschool children 12-59 months of age with persistent asthma on     standardized asthma therapy, the number of asthma exacerbations requiring systemic     corticosteroids will be more frequent in children randomized to receive acetaminophen as     compared to those randomized to receive ibuprofen on an as needed basis for fevers and pain.   "
128255|NCT01606306|"     The INFANT study will test whether, in preschool children 12-59 months of age with persistent     asthma, the following Step 2 asthma therapies will provide similar degrees of asthma control:        1. Daily inhaled corticosteroid (ICS) treatment,        2. Daily leukotriene receptor antagonist (LTRA) treatment, and        3. As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.   "
128256|NCT01606293|"     Objectives:      Primary: 1. To assess the feasibility of using social networking groups to survey patients     with rare cancers.      Secondary:1. To elucidate the current means for diagnosis and treatment of women with small     and large cell carcinomas of the cervix. 2. To evaluate anxiety regarding diagnosis,     treatment, and recurrence among women with small and large cell carcinomas of the cervix.   "
128257|NCT01606280|"     This study examines the value of stem cell transplantation in managing light chain     amyloidisis.   "
128258|NCT01606267|"     The purpose of this study is to to measure the effect of the HEP+ICCM program relative to     routine HEP approach in rural Ethiopia on changes in coverage of case management of common     childhood illnesses and severe acute malnutrition, reductions in mortality among children     under the age of five, and improvements in nutritional status using a rigorous evaluation     design.   "
128259|NCT01606254|"     The purpose of this study is to assess the pharmacokinetics (the study of the way a drug     enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in     participants with schizophrenia (psychiatric disorder with symptoms of emotional instability,     detachment from reality, often with delusions and hallucinations, and withdrawal into the     self).   "
128498|NCT01603134|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, cross over comparative pivotal study. The purpose of this study is to assess the     bioequivalence between Test Product and the corresponding Reference Product under fasting     condition in normal, healthy, adult, human male subjects.   "
128260|NCT01606241|"     This phase I clinical trial studies the side effects of vaccine therapy and cyclophosphamide     in treating patients with stage II-III breast cancer or stage II-IV ovarian, primary     peritoneal or fallopian tube cancer. Vaccines made from peptides may help the body build an     effective immune response to kill tumor cells. Drugs used in chemotherapy, such as     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine     therapy and cyclophosphamide may kill more tumor cells.   "
128261|NCT01606228|"     The purpose of this study is to explore the tolerability, safety and efficacy of flexibly     dosed paliperidone extended release (ER) among patients with schizophrenia.   "
128262|NCT01606215|"     This is a randomised, double-blind crossover study to study the effect of intravenous     treatment with autologous (derived from the individuals themselves) mesenchymal stem cells     (MSCs)in patients with multiple sclerosis (MS).      Current treatments for MS target the immune system and are not curative. There is much     interest in MSCs as they have the potential to not only affect the immune system but may also     promote repair. This study will use MSCs that are harvested from the bone marrow and grown     for up to 52 days before being given back to the person from whom they were harvested. This     avoids any chemotherapy so is therefore safer than other types of stem cells. In this     crossover study, everyone will receive their own stem cells back but in half it will be     delayed by 24 weeks.      The primary outcomes are to check that the procedure is safe and to measure any changes on     the MRI at 24 weeks. Other more exploratory measures will try to assess effects on repair in     the central nervous system (CNS).   "
128263|NCT01606202|"     A study to investigate the effects of sublingual cannabis based medicine extracts on     neuropathic pain associated with spinal cord injury.   "
128264|NCT01606189|"     A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with     placebo in the treatment of chronic pain due to brachial plexus injury.   "
128265|NCT01606176|"     To investigate the ability of a cannabis based medicine extract to relieve chronic refractory     pain of neurological origin.   "
128266|NCT01606163|"     The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male     adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous     injection.   "
128267|NCT01606150|"     The purpose of this study is to compare two medications used to numb an infant's back when     performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain     cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's     vertebrae. In the past, doctors did not know if newborns could feel the pain from a procedure     like this in the same way that adults do. Investigators now know that the newborns do     experience pain during this procedure, but we do not know the best way to control this pain.     Investigators also think that when the newborns have pain, they move during the test. The     movement can increase the chance of having blood mix with this normally clear fluid leading     to limitations in our clinical application of these results. This study will compare the     injected and topical forms of Lidocaine to see which gives us better pain control and more     clear results. The investigators hypothesize that subcutaneous 1% Lidocaine, due to its     deeper penetration, will be 25% superior to topical liposomal Lidocaine (LMX-4) in both the     rate of clinically useful results and pain scores. The investigators hypothesize that both     forms of Lidocaine will be 25% superior to our historical control cohort in the rate of     clinically useful results.   "
128268|NCT01606137|"     Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it     in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.   "
128269|NCT01606124|"     This phase II trial studies how well Polyphenon E works in treating patients with high-risk     of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal     cancer.   "
128270|NCT01606111|"     The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on     therapy to standard care in patients with acute traumatic brain injury (TBI). The study     duration for each patient is 180 days.   "
128271|NCT01606098|"     The clinical benefit of resection of the primary tumour in patients with synchronous     unresectable metastases is not known. In the literature studies usually describe     retrospective selected patients with synchronous metastases treated with or without resection     of the primary tumour. All these studies are biased in patient selection and there are no     prospective randomized studies on this topic. In patients with few or absent symptoms of the     primary tumour, arguments both in favour and against initial resection have been presented,     and therefore a randomized trial is warranted. Although recent publications suggest that     resection of the primary tumour in synchronous metastasized colon cancer patients might not     be necessary, this appears to be based on feasibility and not on clinical outcome. Several     studies comparing large groups of patients with or without resection of the primary tumour     suggest an improved survival when the primary tumour is resected. A potential benefit of     resection of the primary tumour is to prevent complications of the primary tumour during     chemotherapy treatment or during later stages of the disease. A recent analysis of the CAIRO     and CAIRO2 data showed that metastatic colon cancer patients who had a resection of the     primary tumour prior to study entry, had an improved survival compared to patients without a     resection of the primary tumour. However, these patients were selected after the primary     tumour was resected and therefore these results are not corrected for surgical morbidity and     mortality. The investigators here propose a randomized trial in order to demonstrate that     resection of the primary tumour does improve overall survival.   "
128299|NCT01605734|"     TACE is widely used in patients with unresectable HCC. However, it is a non-curative     approach; thus ,strategies to further improve the survival of these patients are needed.     Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic     therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that     the combination of TACE with sorafenib could improve the survival of patients with     unresectable HCC.   "
128311|NCT01605578|"     The purpose of this study is to compare, in healthy women, the adipose tissue composition     between abdomen and thigh and then determine whether differences exist independently of the     state of obesity.      The findings of this study may help to explain the mechanism contributing to a beneficial     role of gluteo-femoral fat contrasting with a deleterious role of abdominal fat on     cardiovascular and metabolic dysfunctions.   "
128272|NCT01606085|"     The purposes of this study are:        1. to develop and test an integrated self care intervention for Heart Failure (HF)patients          with Diabetes (DM) for its effects on patient outcomes including health related quality          of life (HRQOL), physical function and health resource utilization.        2. to assess the costs and cost effectiveness of the intervention.      The intervention is designed to go beyond usual care of providing separate Heart Failure (HF)     and Diabetes (DM) patient education by educating HF-DM patients on integrated self care and     self management related to a HF-DM diet, HF-DM medication-taking behaviors, physical     activity, and HF-DM symptom monitoring and management. An integrated self care intervention     will compare HF-DM patients who receive the intervention with those who receive usual     care-attention control for effects on patient outcomes,self care process measures, and health     care utilization. If effective, the intervention will lead to improved self care, improved     quality of life, and reduced health care resource use and costs. This study will facilitate     greater understanding of self care within the context of two chronic illnesses and will lead     directly to improved clinical practice and future research on comorbid self care in Heart     Failure.   "
128273|NCT01606072|"     The propose for this study is to evaluate the safety and tolerability of desmopressin when     administered perioperatively to patients with breast cancer undergoing surgery as first     treatment, and select the optimum dose for the clinical development of the product.   "
128274|NCT01606059|"     The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920     in healthy male volunteers under fasting condition.   "
128275|NCT01606046|"     The purpose of this study is to compare the effects of vapocoolant spray and topical     lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle     electromyography.   "
128276|NCT01606033|"     This study aims to assess anxiety/depression and life quality of patients included in     clinical trials versus patients treated in a standard way.   "
128277|NCT01606020|"     The effects of sleep deprivation (SD) on performance, while contradictory at first glance,     are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal     versus prolonged exercises. This latter type of exercise leads to the most important     performance decrements after SD.   "
128278|NCT01606007|"     The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS     -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin     (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of     this treatment will also be studied.   "
128279|NCT01605994|"     Includes a placebo-controlled sequential, ascending multiple-dose panels (10 panels, 8     ascending doses, and 2 fixed Japanese Panels exploring safety, tolerability, and     Pharmacokinetic (PK) measures   "
128280|NCT01605981|"     This is an open label, non randomized, prospective, multicenter, phase II clinical trial     evaluating nilotinib 400 mg BID for the treatment of newly diagnosed CML-AP patients.      Patients enrolled into the study will receive 400mg of nilotinib, orally, twice daily     (800mg/day)   "
128281|NCT01605968|"     Study objective:      The objective of this study is to evaluate through clinical criteria the clinical efficacy     and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as     effective and safe as Aquacel® Ag. Dressing.      Study devices:        -  Study device: BCT Silver Bandage        -  Comparator device:ConvaTecAquacel® Ag Hydrofiber Dressing      Study design:        -  Randomized, Open-label, interventional, comparative, preventive study with Blinded          evaluator.        -  All subjects must meet all the inclusion & exclusion criteria to enter this study in          pre-operative phase.        -  Eligible subjects will be enrolled after a scheduled operative procedure.        -  There is SEVEN visits in this study (one screening eligibility phase up to 7 days before          OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th          day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.        -  During each scheduled visit, each subject will have colored picture of his wound after          dressing been removed, and on visit V6 for wound evaluation by blinded PI.      Number of subjects: It is expected to recruit ≧150 eligible subjects.      Study Duration: About eighteen month.   "
128282|NCT01605955|"     The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in     comparison to gold-standard measurements of blood SaO2 by a CO-oximeter   "
128283|NCT01605942|"     This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior     segment inflammation and pain following cataract extraction with lens implantation.   "
128284|NCT01605929|"     The primary objective of this prospective, descriptive study is to evaluate the success rate     of the retroclavicular brachial plexus block and catheter placement in 60 adult patients     undergoing hand, wrist, or forearm surgery. The investigators will also evaluate any     difficulties performing the procedure, the onset time and distribution of the block,     incidence of adverse events, and patient's acceptance of the block.   "
128285|NCT01605916|"     The objective of this study will be to investigate the safety and tolerability of AZD6244     given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients     with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung     Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following     the combination regimen dose escalation phase (Part A) of the study additional patients may     be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability,     pharmacokinetics and biological activity of the combination in this patient population.   "
128286|NCT01605903|"     Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in     children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous     in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal     anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines,     published by the American Academy of Otolaryngology, advocated use of ibuprofen after     tonsillectomy. However, NSAIDs are associated with altered platelet function and a     theoretical increased risk of bleeding after surgery. The investigators would like to explore     the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies     demonstrating it is an effective pain medication after tonsillectomy.   "
128335|NCT01605266|"     INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic,     serologic and environmental factors contributing to nephrotic syndrome and disease     progression.   "
128287|NCT01605890|"     The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same     sensibility to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are     appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy     including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment     is limited. The first line optimal treatment has to be defined by a prospective and     randomized evaluation of other strategies. The primary endpoint will be adapted to the     specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical     trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to     the classical triple therapy, shows an immunovirological response, at least, as good as the     one obtained with the triple therapy. The hypothesis is that the low ART response observed in     HIV-2 infection is due to a low virological strength of the ARTs used and that the     combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at     week 48.   "
128288|NCT01605877|"     The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5     D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.   "
128289|NCT01605864|"     Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection     in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to     be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics     together. These antibiotics usually include a cephalosporin and a macrolide. The most     commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most     commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline.      This research is being done to find out how well a new cephalosporin antibiotic, called     ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is     similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in     hospitalized patients based on two research studies. In one study, ceftaroline was better     than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone.     Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe     as ceftriaxone.   "
128290|NCT01605851|"     The primary objective of this study is to evaluate clinical success and performance of the     GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen     Ovale (PFO).   "
128291|NCT01605838|"     BACKGROUND: The brain is very sensitive to both excessive and insufficient flow of blood.     Cerebral blood flow (CBF) is normally auto-regulated by the blood vessels in the brain, but     this protective mechanism is often disturbed after a traumatic brain injury (TBI). Impairment     or loss of the CBF autoregulation makes the brain vulnerable to oscillations of either     arterial blood pressure (ABP) or intracranial pressure (ICP). The ideal management of TBI     patients, therefore, involves continuous measurement and management of the cerebral perfusion     pressure (CPP = ABP - ICP) but the measurement of CPP is currently possible only with     specialized equipment and expertise that is not available in all institutions. The     investigators have converted a no-longer used system that continuously monitors CBF     autoregulation using rheoencephalography (REG) technology into a modern, small,     battery-powered, low-cost monitor (aka BM-1) that acquires the REG signals using only     noninvasive electrodes placed on the skin/scalp. REG data can then be used to calculate the     optimal CPP to maintain in each individual patient. BM-1 is also capable of monitoring     electroencephalography (EEG) and impedance plethysmography (IPG), which can, respectively, be     used to measure brain electrical activity and changes in peripheral blood flow caused by     blood pressure changes.      OBJECTIVES: The primary objectives are to (Obj. 1) demonstrate that REG acquired     noninvasively is equal to the well-established but invasive method using intracranial     pressure (ICP) monitoring, (Obj. 2) retrospectively test the idea that TBI patients have a     less favorable outcome if their CPP were found less optimal using the REG data, and (Obj. 3)     determine if noninvasive IPG or the PPG finger sensor monitoring (used to measure heart rate     in doctor's offices) can replace the invasive monitoring of arterial blood pressure (ABP).      METHODOLOGY: This is an observational study with retrospective data analysis. 20 adult     patients (18-65 yrs) with acute TBI, who meet the inclusion/exclusion criteria, will be     enrolled on a first-come-first-enroll basis. The enrolled patients will have the REG, EEG and     IPG signals monitored for the duration of ICU stay or 15 days, whichever is shorter. Standard     neurological assessment will be made at the patient's discharge from the ICU and at 3 months     after injury. The study is expected to end June 2013.   "
128292|NCT01605825|"     This is a multi-center, safety and tolerability study in subjects with chronic stable     sensorimotor deficits after ischemic stroke. It has been designed as a double-blind,     placebo-controlled, 2-period crossover study.   "
128293|NCT01605812|"     In this study, the investigators examined the capsule-IOL interaction including anterior and     posterior capsule adhesion, contact between posterior capsule and the posterior edge of     intraocular lense (IOL), configuration of capsular bend and the incidence of posterior     capsular opacity (PCO) between high myopia eyes and emmetropia eyes.   "
128294|NCT01605799|"     The goals of this project are        -  1) to evaluate the effectiveness of a CBT treatment module addressing the mental health          and functional impact of killing in the war zone,        -  2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility          of the CBT treatment module, which would be used to further refine the intervention, and        -  3) to gather data on clinician stakeholders' perceptions of acceptability and          feasibility of the CBT treatment module, which would be used to ensure that the module          could be easily integrated into EBT for PTSD.   "
128295|NCT01605786|"     This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a     synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and     immunogenic (Phase 1), functionally active against the erythrocytic stages (Phase 1) and     efficacious (Phase 2) against the pre-erythrocytic stages in protecting against an artificial     malaria challenge using Pf sporozoites in a healthy adult population.   "
128296|NCT01605773|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.   "
128297|NCT01605760|"     The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in     patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust     mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis     and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick     tests, serum-specific IgE and nasal provocation tests were included. Patients were     individually randomised to groups: active or placebo using a double-blind method. A total of     51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R,     Stallergens, France) and 57 in the placebo group were monitored for three years. The patients     had to record on a diary card whenever they used anti-allergic medications.   "
128298|NCT01605747|"     The primary objective of this study is to determine if probiotic prophylaxis has immunologic     and gastrointestinal advantages in pediatric burn patients.   "
128300|NCT01605721|"     Objectives:        1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE          PRIMETM in a cohort of real world patients and lesion subsets.        2. To determine clinical device and procedural success during commercial use of XIENCE          PRIMETM coronary stent      Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM      Study period        -  Patient enrollment: 2011.05 ~ 2012.04        -  End of follow-up period: 2015. 02 (3 years of follow-up)      Primary endpoint      : Target Lesion Failure (TLF) rate at 12 months      Secondary endpoint:        -  In-stent & In-segment Late Loss at 9 months        -  Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3          years (very late)        -  Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)        -  Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years        -  Composite rate of cardiac death and any MI up to 3 years        -  Composite rate of all death and any MI up to 3 years        -  Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat          revascularization up to 3 years        -  Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up          to 3 years        -  Procedural success up to 1 day        -  Angiographic success up to 1 day   "
128301|NCT01605708|"     The purpose of this study is to assess the clinical activity on refractory moderate-to-severe     pruritus of a single intravenous (IV) dose of REGN846 in adult patients with     moderate-to-severe atopic dermatitis (AD).   "
128302|NCT01605695|"     The discovery that inducible nitric oxide synthase (iNOS) circulates in people who are     developing the sepsis pathology has provided an opportunity to develop a first-in-class     diagnostic test for the onset of sepsis. This study is designed to determine the normal human     plasma level of circulating iNOS as the initial reference level against which hospitalized     patients at risk for the development of sepsis can be compared to ascertain if the patient is     at risk for becoming septic based upon an elevated level of plasma iNOS.   "
128303|NCT01605682|"     Berry fruits are widely recognised as natural functional food products. They contain several     different phytochemicals which have potential to modulate human health and wellbeing. There     is however some debate regarding the mechanisms driving their health promoting properties.      Despite the wide health promoting properties of fruit extracts reported in the literature,     considerable interest over the past decade has primarily been focused on their roles in     reducing risk factors associated with cancer and heart disease. Consequently, there remains a     paucity of actual scientific information on their role in modulating brain functions, such as     mood, learning and memory, any decrements of which have very negative impacts on the quality     of life.      A prior study carried out as the first study of my PhD, attempted to bridge this gap in     knowledge and found promising results after acutely supplementing participants with a fruit     based drink. The findings showed that there was an increased vigilance on attention related     psychometric tasks and an increased feeling of calmness. The investigators have hypothesised     that these cognitive enhancing effects are due to the monoamine oxidase (MAO) inhibiting     effect of the fruit drink, our ex vivo findings support this with a 96% reduction in MAO-B     activity.      The aims of the current study are threefold: to extend the findings of my previous     investigation by extending the tasks explored; to ascertain if the positive results of the     first study are dose dependent; and to investigate whether a lower dose can facilitate     greater changes in behaviour.   "
128304|NCT01605669|"     According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with     asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE)     performed annually for severe disease, every 1-2 years for moderate disease and every 3-5     years for mild disease. This results in a multitude of screening studies in the investigators     patient population. 3M has developed a new stethoscope and phonocardiography software capable     of identifying the peak intensity of the AS murmur and tracking it as it moves towards the     second heart sound potentially indicating increasing severity of disease. Currently there     exists no data to demonstrate that the aortic stenosis acceleration index (ASAI) correlates     to disease severity or progression of disease. The ASAI measures the timing of the peak     intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1)     where s1 is the first heart sound; S2 is the second heart sound and x with the time between     S1 and the peak intensity of the murmur. In this study the investigators propose to correlate     the ASAI to standard TTE measurements of aortic stenosis severity.   "
128305|NCT01605656|"     The goal of this study is to better understand the factors that might prevent HIV-positive     women from having routine pap smear screenings. Researchers also want to learn what might     make it easier or encourage women to have these screenings.   "
128306|NCT01605643|"     Use of tobacco is very high among Alaska Native women. The investigators are conducting a     three phase study. The first phase will examine biomarkers of tobacco exposure in pregnant     women and their newborns. The second phase is a qualitative study to translate the biomarker     findings into intervention messages. The third phase is a pilot of the biomarker feedback     intervention compared with a control condition.   "
128307|NCT01605630|"     The no show rate for mammography screening is high among Navajo women. One barrier to     preventive screening is a lack of cancer literacy including low knowledge and cultural     attitudes (e.g., fatalism) about screening. The investigators will examine the potential     feasibility and acceptability of a cancer literacy intervention for families of Navajo women     who have no showed for three consecutive times to mammography screening who have never or     rarely been screened in the past.   "
128308|NCT01605617|"     The investigators are studying two FDA-approved modalities used to treat overactive bladder     to determine if they improve overactive bladder with or without urge incontinence when used     together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS and     fesoterodine fumarate.   "
128309|NCT01605604|"     The pupose of the study is to determine the effectiveness of the Buddhist integrated group     intervention improve the mindfulness in adolescents by a randomized controlled trial.The     study divede the adolescents in two groups group A recieved the 8 time Buddhist group     interventions.Group recieved nothing.The measurement were done pre and post intervention at     week1 and week8.The mindfulness score ,the EQ,the MASS score were compared between both     groups.   "
128310|NCT01605591|"     The purpose of this study is to comparing the effects of different double-lumen endotracheal     tube's bending type in tracheal intubation.   "
128312|NCT01605565|"     Cystic fibrosis (CF) is characterized by airway inflammation and infection leading to     progressive destruction of lungs. One of the most important abnormalities in CF is an     abnormal processing of the mutated CFTR protein through the endoplasmic reticulum that causes     abnormal location or even absence of the protein at the apical plasma membrane of airway     epithelial cells. This abnormality results in a marked dehydration of the airway surface     fluid, decreased mucus transport and airway obstruction. Nevertheless, the events that occur     very early during the progression of the disease at the airway level in infants are not     known. At cellular level, it has also been reported that the CFTR expression and localization     could be related to the differentiation state of the airway epithelium. Furthermore, it has     been reported that gap junctions could be involved in dysregulate inflammation process. In CF     infants, many answers are still lacking. For a better understanding of the early stages of     cystic fibrosis, it is of major interest to study respiratory epithelial cells obtained as     early as possible. In 15 CF infants and 15 control infants, a nasal brushing will be     performed by means of a soft sterile cytology brush. Samples will be used for cytological and     functional studies: ciliary beating frequency, cAMP-dependent chloride efflux, potassium     efflux, tight and gap junctions functionalities. These studies will be done in basal     conditions and will be repeated after activation of the nasal epithelial cells by the     bacteria, such as Staphylococcus aureus, which can be found very early in the course of CF     disease.   "
128313|NCT01605552|"     The objective of this clinical trial is to evaluate whether a computerized depression     treatment, delivered before the onset of heart disease, reduces the risk of heart disease in     the future. Participants in this trial will be primary care patients who are depressed but do     not have a history of heart disease. Half of these patients will receive a standard treatment     (usual care), and the other half will receive eight weeks of an evidence-based psychological     treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment     program for depression. To evaluate change in heart disease risk, the investigators will     measure the functioning of the arteries using ultrasound before and after the treatment. It     is hypothesized that patients who receive Beating the Blues® will show greater improvements     in both depression and artery function than patients who receive standard treatment.   "
128314|NCT01605539|"     Despite the current available therapies for opioid-dependent patients, most patients relapse.     This research project focuses on the development of a novel compound, cannabidiol, to     modulate opioid craving in humans based on animal models showing its selective effectiveness     to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse     would be of tremendous medical and public health value.   "
128315|NCT01605526|"     This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and     efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma.     Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of     each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each     cycle for up to 6 cycles.   "
128316|NCT01605513|"     The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective     in the treatment of HCV patients.   "
128317|NCT01605500|"     The purpose of this study is to determine whether the alert tones emitted by the latest     generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to     patients.      ICD patients can have difficulties hearing the beeps, which are designed to notify patients     of possible lead or generator malfunction. In fact, the only published study of this issue,     conducted at Englewood Hospital and Medical Center, revealed that only 50% of patients with     older Medtronic devices were able to hear alerts. Since then, modifications to the alert have     been made by Medtronic. This study will establish the real-world value of these changes and     also provide useful in vivo information regarding the validity of the in vitro techniques     which have been used thus far to design the Patient Alert feature.   "
128318|NCT01605487|"     Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg     doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier     element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany)     will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C     simultaneously in a standardized and reproducible way and thus the determination of     individual temperature and/or stimulation time thresholds.      In addition mediators related from activated must cells such as histamine, PAF, PGD2 should     be identified in the period between the application of stimulus and the appearance of     symptoms of cold urticaria and should be characterized qualitatively and quantitatively.   "
128319|NCT01605474|"     This study examines whether outpatient pre-induction cervical ripening improves patient     satisfaction and is safe and effective.   "
128320|NCT01605461|"     Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose     of [14C]-BI 207127 and to characterize the metabolic profile following single dose     administration.   "
128321|NCT01605448|"     The investigators are investigating the benefits of a mind/body intervention, Mindfulness     Based Stress Reduction, for adults with Mild Cognitive Impairment.   "
128322|NCT01605435|"     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the     brain. The purpose of this study is to determine the optimal subcutaneous ghrelin dose as a     potential intervention for frail elderly individuals. We will examine food intake and     metabolic parameters after placebo and ghrelin administration at three escalating     subcutaneously administered doses.   "
128336|NCT01605253|"     The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is     effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep     disturbance. The investigators will also examine the impact of treatment on sleep patterns,     memory recall bias, and level of inflammatory markers (cytokines). The investigators predict     eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms,     memory recall bias, and level of inflammatory markers.   "
129271|NCT01593072|"     The purpose of this study is to evaluate the safety and tolerability of healthy male and     female subjects with intravenous (IV) infusions of AVI 7537 compared to matched placebo in     and to evaluate the pharmacokinetics (PK).   "
128323|NCT01605422|"     Dietary pulses (beans, peas, chickpeas, and lentils), more commonly known as legumes, are     generally recognized as healthy components of the diet. Canada's Food Guide encourages     consumptions of meat alternatives, such as beans more often; and the dietary guidelines for     Americans both recommend consumption of 3 cups of legumes per week. However, there remains     insufficient information on the usefulness of these foods in protecting heart health. To     improve evidence-based guidance for dietary pulse recommendations, the investigators propose     to conduct a systematic review of the effect of dietary pulse consumption on after-meal blood     sugar levels, appetite, and food intake regulation to help explain their mechanism for     improving longterm blood sugar and body weight control. The systematic review process allows     the combining of the results from many small studies in order to arrive at a pooled estimate,     similar to a weighted average, of the true effect. The investigators will be able to explore     whether eating pulses has different effects between men and women, in different age groups     and background disease states, and whether or not the effect of pulses depends on the dose     and background diet. The findings of this proposed knowledge synthesis will help improve the     health of Canadians through informing recommendations for the general public, as well as     those at risk of heart disease and diabetes.   "
128324|NCT01605409|"     Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation     algorithms and postcardiac arrest care have been improved there is an urgent need for     measures leading to a higher survival rate.      Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients body)     is a method which has shown good results in case reports and animal studies for cardiac     arrest care.      The study will be performed as comparison between the new treatment option of ECPB versus the     standard of care treatment.      Aim of our study is to determine the feasibility of ECPB installed in an emergency department     to improve the rate of patients restoration of spontaneous circulation.   "
128325|NCT01605396|"     The purpose of the study is to evaluate the progression free survival (PFS) of ridaforolimus,     dalotuzumab and exemestane (R/D/E) compared to the combination of ridaforolimus and     exemestane (R/E) in post-menopausal participants with breast cancer.   "
128326|NCT01605383|"     The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral     head in comparison to the standard treatment of isolated core decompression.      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by ex-vivo expanded autologous     mesenchymal stem cells fixed in allogenic bone tissue.      The working hypothesis proposes that the tissue engineering is a valid and useful technique     to achieve bone regeneration, avoiding the progression to collapse of the femoral head.   "
128327|NCT01605370|"     The purpose of this study is to evaluate if a drug called nebivolol can reverse inappropriate     left ventricular mass (LVM) when compared to the standard of care drug metoprolol.   "
128328|NCT01605357|"     Cerebral edema is seen heterogenous group of neurological disease states that mainly fall     under the categories of metabolic, infectious, neoplasia, cerebrovascular, and traumatic     brain injury disease states. Regardless of the driving force, cerebral edema is defined as     the accumulation of fluid in the brain's intracellular and extracellular spaces. This occurs     secondary to alterations in the complex interplay between four distinct fluid compartments     within the cranium. In any human cranium; fluid is contained in the blood, the cerebrospinal     fluid, interstitial fluid of the brain parenchyma, and the intracellular fluid of the neurons     and glia. Fluid movement occurs normally between these compartments and depends on specific     concentrations of solutes (such as sodium) and water. In brain-injured states, the normal     regulation of this process is disturbed and cerebral edema can develop. Cerebral edema leads     to increased intracranial pressure and mortality secondary to brain tissue compression, given     the confines of the fixed-volume cranium. Additionally, secondary neuronal dysfunction or     death can occur at the cellular level secondary to the disruption of ion gradients that     control metabolism and function.      While studies utilizing bolus dosing of hyperosmolar therapy to target signs or symptoms of     increased intracranial pressure secondary to cerebral edema are numerous, there is a paucity     of studies relating to continuous infusion of hyperosmolar therapy for targeted sustained     hypernatremia for the prevention and treatment of cerebral edema. The investigators     hypothesize that induced, sustained hypernatremia following traumatic brain injury will     decrease the rate of cerebral edema formation and improve patient outcomes.   "
128329|NCT01605344|"     The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetic     profile of irinotecan and SN-38. To further evaluate the safety of atorvastatin in     combination with FOLFIRI. To further evaluate the safety and of irinotecan in combination     with atorvastatin.   "
128330|NCT01605331|"     As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH     deficiency has been known to improve metabolic impairment and quality of life. Patients,     however, do have to tolerate daily injections of GH (rhGH).   "
128331|NCT01605318|"     This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles,     once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with     metastatic colorectal cancer who have been previously treated with at least one prior     irinotecan-containing regimen. The study is being done to evaluate whether the study drug is     safe and tolerable at different dose levels with these dosing schedules and to obtain     preliminary information on its efficacy.   "
128332|NCT01605305|"     The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to     progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic     esophagus.   "
128333|NCT01605292|"     Radial artery access for cardiac catheterization can require multiple attempts. Multiple     attempts increase the time required, patient discomfort, and the risk of arterial spasm.     Ultrasound guidance has been shown in other studies to reduce the number of attempts and     complications in central venous and femoral artery access. This study will test if the     addition of ultrasound guidance reduces the number of attempts and time required to access     the radial artery.   "
128334|NCT01605279|"     Low systemic flow as measured by Doppler-echocardiography has been associated with poor     neurological outcome. Yet, it has not been systematically evaluated whether the treatment of     this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low     systemic flow in preterm infants with dobutamine has any effect on the cerebral circulation     and in newborn prognosis.   "
128337|NCT01605240|"     For simple fractures treated in the emergency department with cast immobilisation only,     ibuprofen has been shown to be superior to, or a least or equivalent to codeine with less     side effects. These and other studies have commented that their results may not be applicable     to children who have fractures that require reduction. There is currently no literature on     the management of postoperative pain following reduction of paediatric fractures. The     investigators aim therefore is to investigate whether either of the two most commonly     prescribed analgesics is superior to the other for postoperative pain management following     closed reductions of paediatric forearm fractures. Also, if one agent has more side effects     than the other.   "
128338|NCT01605227|"     This study will evaluate the effect of cabozantinib compared to prednisone on overall     survival in men with previously treated metastatic castration-resistant prostate cancer with     bone-dominant disease who have experienced disease progression on docetaxel-containing     chemotherapy and abiraterone or MDV3100.   "
128339|NCT01605214|"     Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality     following lung transplant and is characterized by acute lung injury and capillary leak     leading to an increase in extravascular lung water index (ELWI) and impaired graft function.     PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be     life-threatening and can also lead to impaired long term lung function. In ARDS, a     restrictive fluid strategy has been associated with an improvement in lung function and     outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid     management and limiting the extent of ELWI that accumulates in the setting of PGD are     lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability     index (PPI) represents a novel approach to fluid management, which has been used in patients     with ARDS, but to date not in the transplant setting. To determine if these measurements may     better guide the management of lung transplant patients, the investigators first wish to     establish whether these methods are able to predict the onset of clinical pulmonary edema     earlier, whether they correlated with traditional markers of PGD, and whether they may be     useful for predicting outcomes.      AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of     pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD)      AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and     severity of PGD.      AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can     predict the onset of PGD.      b) Across different strata of PGD, the investigators will determine whether ELWI and PPI have     a differential effect on duration of mechanical ventilation.      The results of the study will be used for the following:        1. Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more          discriminatory and have a stronger association with outcome compared to the current gold          standard.        2. Provide the means of early identification of those as risk of developing PGD in order to          guide management decisions or future therapeutic interventions aimed at preventing or          treating PGD.        3. Provide the requisite groundwork for a clinical trial comparing the effects of an          ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.   "
128340|NCT01605201|"     The purpose of this study is to investigate the safety and feasibility of implanting an     engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes     within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or     trochlea of the knee after a traumatic injury.   "
128341|NCT01605188|"     The aim of our study is to prospectively identify, at diagnosis, factors predictive of     non-response or loss of response in patients with inflammatory bowel disease treated with     anti-TNF.   "
128342|NCT01605175|"     The aim of this study is to prospectively identify, at diagnosis of the disease, factors     predictive of mucosal healing in patients with inflammatory bowel disease treated with     anti-TNF.   "
128343|NCT01605162|"     This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the     selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ)     in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease     progression. Eligible subjects must have measurable disease according to Response Evaluation     Criteria in Solid Tumors (RECIST).   "
128344|NCT01605149|"     Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is     unclear how and when it effects the bone density. The investigators are studying the effects     of diabetes on bone mass compared to children without diabetes.   "
128345|NCT01605136|"     This is a randomized placebo-controlled study to be conducted in two parallel study arms for     a six month period (three doses). Between 75 and 100 eligible patients will be enrolled.     Patients will receive afamelanotide (16 mg implants) or placebo according to the following     dosing regimen:        -  Group A will be administered afamelanotide implants on Days 0, 60 and 120        -  Group B will be administered placebo implants on Days 0, 60 and 120      The number and severity of phototoxic reactions, the type and duration of sun exposure,     treatment-emergent adverse events and the use of concomitant medication will be recorded by     patients in study diaries between Days 0 and 180. Quality of life will be measured using the     DLQI and EPP-QoL at Days 0, 60, 120 and 180. Participants will visit the clinic on Days 60,     120 and 180 for assessments of adverse events.      A subset of patients will be photoprovoked on the lower back and dorsal surface of the hand     and the minimal symptom dose (MSD) will be determined on Days 0, 30, 60, 90 and 120.   "
128346|NCT01605123|"     The investigators hypothesize that cardiovascular and metabolic alterations due to obesity     already manifest at childhood age.      To identify these alterations and risk factors, the investigators have established a cohort     of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of     cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity     and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally     after 5, 7 and 9 years.      In addition, the investigators will assess the effects of increased physical activity and     exercise on cardiovascular function.   "
128347|NCT01605110|"     The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen;     2.0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST)     (patient's breathing room air; 2.0 ATA; 90 minute exposure) in reducing edema and ecchymosis.     HBOT will be applied as a single pre-operative and a single post-operative treatment for     patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT 2-4 hours prior     to undergoing surgery, 2-4 hours post-surgery and healing will be assessed at day 3, 10, 21,     30 & 90 days after surgery. Edema and ecchymosis will be assessed in a time series to     determine the extent that HBOT reduces these clinical signs. The primary null hypothesis to     test will be that no differences in scores will exist between treatment and control at day 3,     10 & 21 post-surgery. A secondary null hypothesis to test is the time required to change a     score will be no different between the two groups.      HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment   "
128499|NCT01603121|"     The primary goal of the study is to investigate the safety and tolerability of the     investigational drug lisofylline, when administered under the skin or in the vein, in people     with type 1 diabetes. A second aim is to determine how much drug is available in the blood     after injection under the skin, compared to injection in the vein.   "
128348|NCT01605097|"     This study will investigate the feasibility of using technology of ultrasound guided HDR     brachytherapy to focally increase dose to regions within the prostate that are heavily     infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL)     can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The     magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS)     prior to the brachytherapy procedure to design a dose distribution that will encompass the     malignant volume with higher than the prescription dose. By its nature, brachytherapy has     subvolumes that receive (for example)125% of the prescription dose or 150% of the     prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to     coincide with the DIL. The limit of dose escalation has been reached at whole prostate     external beam doses of 81-86 Gy and still failure rates for intermediate and high risk     disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided HDR     brachytherapy is perfectly suited to achieving this.   "
128349|NCT01605084|"     The purpose of this study is to determine the proportion of subjects with HIV-1 RNA < 50 c/mL     at Week 48 in patients who failed their first line therapy containing a non-nucleoside     reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor   "
128350|NCT01605071|"     The aim of the current study is to test whether the effect of estrogen on insulin metabolism     depends on the timing of treatment relative to when a woman went through menopause. The     investigators hypothesize that estrogen will improve insulin sensitivity in early     postmenopausal women, but decrease insulin sensitivity in late postmenopausal women.   "
128351|NCT01605058|"     The purpose of this study is to evaluate the visual performance of a trifocal intraocular     lens at distance, near and intermediate viewing, by way of visual acuity measurement,     contrast sensitivity.      Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.   "
128352|NCT01605045|"     The aim of this study is to evaluate the effects of screening using the fluoroscopy-save     function on reduction of radiation exposure and quality of angiogram during cardiac     catheterization when compared to traditional cinematography-guided coronary angiography.   "
128353|NCT01605032|"     This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line     stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy     before a peripheral blood stem cell transplant may stop the growth of cancer cells by     stopping them from dividing or killing them. After treatment, stem cells are collected from     the patient's blood and stored. The stem cells are then returned to the patient to replace     the blood-forming cells that were destroyed by the chemotherapy.   "
128354|NCT01605019|"     The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an     FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks     in blood vessels during surgery.      This study is evaluating CoSeal™ when it is applied to various areas of the heart during the     surgery to implant a Left Ventricular Assist Device (LVAD). the investigators are looking for     evidence which indicates that CoSeal™ may be useful in reducing or stopping bleeding, the     occurrence of micro emboli (small particles of air or blood), and the formation of cardiac     adhesions (scar tissue strands that may form around the heart in the area of a previous LVAD     operation) in patients who undergo LVAD implantation surgery.   "
128355|NCT01605006|"     This post-approval study will follow 60 participants who have ALS, documented chronic     hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical     implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who     are successfully implanted with the device will use it for daily diaphragm conditioning     sessions. Participants will be followed for at least two years (until the last enrolled     participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures     will be assessed.   "
128356|NCT01604993|"     The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates     on aortic augmentation index, brachial and aortic blood pressures, and subendocardial     viability ration (SEVR).   "
128357|NCT01604980|"     Minimal data are available on protein requirements throughout the lifespan. Currently     available recommendations are based on nitrogen balance data. The limitations of the nitrogen     balance method have been well described. Importantly, nitrogen balanced underestimates     requirements.      The current DRI requirement for healthy adult males is based on the reanalysis of the     nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by     Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83     (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group     estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2     g/kg/day (mean and RDA).      Currently there are no studies on protein requirement in the elderly. In a recent nutrition     survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70     years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents     about 15 % of calories. Depending on the calculations used for ideal body weight some older     adults could be getting higher or lower than requirement. There is no scientifically derived     protein estimate for older adults. Therefore there is a need to measurer protein requirement     in that population.      The goal of this study therefore is to measure the protein requirement of female elderly     subjects >75 years using the IAAO technique.   "
128382|NCT01604642|"     The goal of the investigators study is to investigate the role of a hormone named Activin A     (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the     investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy     gene program. To answer this question, the investigators plan first to compare circulating     levels of ActA in cancer patients with and without cachexia. In a second step, the     investigators would like to assess whether ActA circulating levels are predictive for the     development of cachexia and short survival.   "
128383|NCT01604629|"     The purpose of this study is to demonstrate that patients with Spondylarthropathies in     remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior     to the currently recommended dose schedule.   "
128384|NCT01604616|"     The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon     liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment     ,associated with giant retinal tears.   "
128358|NCT01604954|"     Weight management is a critical issue in developed countries where the prevalence of obesity     is always increasing. While the mismatch of energy intake and energy expenditure is     recognized as a leading cause of obesity, knowledge related to the determinants of healthy     eating patterns are still an important issue to further address. Various nutrition-education     campaigns have been implemented as a way to increase knowledge about healthy foods and     facilitate the adoption of better eating behaviors. There is currently social and politic     pressure on health authorities to increase availability of nutrition information as a way to     tackle the obesity epidemic. Does nutrition information on food labels really contribute to     improving dietary intake among the population and to helping them to better manage their body     weight? Some evidence suggests that describing foods as healthy might have unintended     enhancement effects on the acute amount of food and calories consumed. A better understanding     of how and why nutrient and calorie labels influence acute and chronic intake is thus needed.     This study investigate how providing nutritional information on food labels influences intake     and eating-related variables over a 10-day period among women characterized by varying levels     of adiposity. As it has never been investigated before, the present research will provide     important knowledge on the long-term impacts of different food labeling strategies on the     regulation of food intake. It will also help to determine whether weight status could     influence the effects of perceptions about foods on intake, so that the investigators can     identify individuals who mostly tend to overeat in specific situations. Consumer advocacy     organizations are urging government to adopt policies regarding food labeling. Such research     is thus of great relevance for the promotion of healthy body weight at the population level,     as it will clearly contribute to assess how food labels should be used by health governing     bodies in the context of the obesity epidemic.   "
128359|NCT01604941|"     The purpose of this study is to evaluate SSP-004184AQ in patients with transfusional iron     overload whose primary diagnosis is hereditary or congenital anemia.      SSP-004184AQ is an iron chelator under development for chronic daily oral administration to     patients with transfusional iron overload.   "
128360|NCT01604928|"     The study is intended to test efficacy, safety and tolerability of two doses of YM178 against     placebo and tolterodine to treat patients with symptoms of over active bladder.   "
128361|NCT01604915|"     Single shot caudal epidural block is one of the most widespread technique for pediatric pain     management after infraumbilical surgical procedures.      However, in a significant proportion of patients, despite good initial analgesia from a     caudal block with local anesthetic, pain develops after the block resolves.      In order to decrease postoperative analgesic requirements after caudal block, various drugs     such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been     investigated. However, their use has been limited by adverse effects in children.      Recently, many study suggested that epidurally administered dexamethasone could reduce the     incidence and severity of postoperative pain in adults. But there is no study concerning the     use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.      The investigators performed prospective randomized double-blind study to examine the     analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal     analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.      80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective,     randomized, double-blinded study. After inhalation induction of general anesthesia, caudal     block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg     added to ropivacaine 0.15% 1.5ml/kg was administered to Group R , dexamethasone 0.1mg/kg     added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain was recorded at 30min and     1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs     Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration     of hospital stay, an expected average of 3 hours.      After discharge, rescue analgesic consumption, pain scores, and adverse effects were     evaluated for 24h.      The time to first supplemental oral analgesic medication demand was defined as the time from     the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation.     Twenty-four hours after surgery, reports of delayed side effects and demands for rescue     analgesics from the child were gathered from parents via a telephone interview.   "
128362|NCT01604902|"     PURPOSE - The purpose of this study is to identify and determine miRNA expression and their     targets before and during biological treatment of psoriatic patients.      HYPOTHESIS - Changes in the expression of specific miRNAs play an important role for the     cytokine expression profile seen in lesional psoriatic skin. miRNAs may therefore serve as a     potential target for future anti-psoriatic treatment as well as possible predictors of     biological treatment response.      PERSPECTIVES - The results from this novel research project will increase the investigators     understanding of the underlying mechanisms leading to psoriasis. Furthermore it is possible     that predictors of treatment response can be identified. Identification of biomarkers     predicting treatment outcome will individualize patient care, reduce number of treatment     failures and thereby have a tremendous socio-economic impact and increase the patients     quality of life.   "
128363|NCT01604889|"     The study design includes an open-label, dose escalation phase followed by a blinded,     randomized phase, which combines INCB024360 (an oral IDO1 inhibitor) with an approved therapy     and compares to approved therapy plus placebo in metastatic melanoma patients.   "
128364|NCT01604876|"     The purpose of this clinical trial is to investigate whether light therapy is a suitable     treatment option for depression and insomnia in Parkinson's disease.   "
128365|NCT01604863|"     The primary purpose of this study is to determine the maximally tolerated dose (MTD) of     HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus     carboplatin, cisplatin plus etoposide, or docetaxel.   "
128366|NCT01604850|"     This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin     (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus     (HCV) infection as assessed by the proportion of participants with sustained virologic     response (SVR) 12 weeks after discontinuation of therapy (SVR12).   "
128367|NCT01604837|"     The recommended entry angle for superior hypogastric plexus block is different among     references, and there is a need for suggesting a more accurate entry angle for this     procedure. The investigators are trying to evaluate the entry angle for superior hypogastric     plexus block by measuring these angle on the computed tomography image and apply these angle     to the real patients.   "
128368|NCT01604824|"     The purpose of this study is to assess the pharmacodynamic (PD) effect of alirocumab on serum     low-density lipoprotein cholesterol (LDL-C) in patients with autosomal dominant     hypercholesterolemia (ADH) and gain-of-function mutations (GOFm) in 1 or both alleles of the     proprotein convertase subtilisin/kexin type 9 (PCSK9) gene or with a loss-of-function     mutation (LOFm) in 1 or more alleles of the apolipoprotein B-100 gene (apoB).   "
128369|NCT01604811|"     Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent     published works pointed out that urine and serum markers could be used for detection of     prostatic inflammation.      The aim of the study is to assess the activity on inflammation biomarkers (serum and urine     inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the     treatment of urinary symptoms related to BPH.      The potential links between serum and urinary markers of inflammation and BPH clinical     symptoms at baseline and on treatment will be explored.   "
128370|NCT01604798|"     No ideal serum biomarker currently exists for the early diagnosis of colorectal cancer (CRC).     Therefore, it is urgent that accurate and reliable serum biomarkers be identified.   "
129272|NCT01593059|"     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring     coronary revascularization with Drug Eluting Stents (DES).   "
128371|NCT01604785|"     There has been little advancement in abortive migraine therapies in recent decades, and few     proven treatments exist for acute migraine, particularly in children. Propofol, a general     anesthetic, has been suggested to be effective for the treatment of migraine headaches in     adults when used in subanesthetic doses (lower doses than those used for anesthesia or     sedation). Initial retrospective review of the investigators experience with propofol for     migraine in children suggests that it is safe and may be more effective than standard     treatments used in the emergency department. The investigators retrospective series had a     small subject population and a larger study is needed to compare propofol to current     available treatments.      All subjects presenting to the pediatric emergency department with signs/symptoms of migraine     headache will be screened for the study. Subjects who are eligible will be provided     information about the study and consent/assent forms from a member of the research team, and     asked whether they are interested in participating.      All study subjects will receive acetaminophen (Tylenol) or ibuprofen (Motrin) for their     headache if they have not already tried these first-line treatments at home; those with     persistent symptoms requiring further treatment who consent to participate in the study will     be randomized to receive either standard treatment or propofol. Standard treatment currently     consists of a cocktail of medications that include anti-nausea medicines (metoclopramide     and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects     assigned to the experimental group (Propofol) will receive the same intravenous fluids and up     to five doses of propofol. All subjects will undergo assessment of their pain (self-rated on     a scale from 0-10) before and after treatment. During treatment they will have close     monitoring of their vital signs. No additional laboratory tests or procedures are involved.     Post-visit clinical data will be collected from the subject's medical record and subjects     will be called by telephone 24-48 hours after discharge from the emergency department to ask     how they are doing and whether they required any additional treatments such as home     medications or by other medical professionals other than OHSU.      The study data will be presented in summary tables that outline subjects' clinical     presentation prior to treatments, and response to study drug during their visit. The main     variables of interest include effectiveness (determined as a reduction in self-reported pain     score), length of stay in the pediatric emergency department, recurrent headache requiring     emergency treatment within 24 hours and whether any adverse effects occur. These will be     compared between the 2 study groups with basic statistics.   "
128372|NCT01604772|"     This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with     progressive, recurrent, or metastatic adenoid cyst carcinoma (cancer). Akt inhibitor MK2206     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
128373|NCT01604759|"     In this study the investigators are conducting research to determine whether a new optical     device using polarization reflectance spectroscopy can help doctors or dentists identify     abnormalities in the mouth that require follow-up. To establish this, measurements are needed     from a large number of individuals with different abnormalities in their mouth.      The investigators believe the proposed approach has potential to improve and enable mass     screening for precancerous and early cancers of the oral cavity by improving the predictive     value of oral cavity exams, particularly for less experienced practitioners.      The information from this study will be compared to results from the pathology report of the     tissue taken from your mouth.      Hypothesis:        1. Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and          reactive oral lesions.        2. Polarized reflectance spectroscopy can capture low-grade oral lesions that have          characteristics associated with a high risk of progression to cancer.   "
128374|NCT01604746|"     The purpose of this study is to verify the long-term safety of a 2.5 µg, adjuvanted     (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine.   "
128375|NCT01604733|"     Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in     patients taking lipid lowering agents for at least 3 months ( with no drug change or dose     amendment for a minimum of 6 weeks).   "
128376|NCT01604720|"     Sample size definition provides important information, allowing the groundwork for     transparent reporting. The sample predefinition allows the trial to be large enough to be     able to address the question that is being asked.      The aim of the present study is to assess, in all the randomized controlled trials (RCT)     included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of     reporting sample size the accuracy of the calculations, the accuracy of the a priori     assumptions and the effect on the agreement with pooled results in meta-analyses.   "
128377|NCT01604707|"     Background An increasing number of patients are suffering from stress-related symptoms and     diseases. No scientific studies have examined the effects of Medical yoga on stress-related     symptoms in patients in primary care. The purpose of this study was to evaluate Medical yoga     treatment in patients with stress-related symptoms and diagnosis in primary health care.      Methods A randomized, controlled study was performed at a primary health care centre in     Sweden from March to June 2011. Patients were randomly allocated to a control group receiving     standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a     12-week period in addition to the standard care. A total of 37 men and women, mean age 53±12     years, seeking care for stress-related symptoms at the primary health care centre were     included and followed up after the 12-week study period. General stress level (measured using     Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety     and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia     Severity Index (ISI)), pain (visual analogue scale (VAS)) and overall health status (Euro     Quality of Life-VAS (EQ-VAS)) were measured before and after 12 weeks.   "
128378|NCT01604694|"     Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently     more and more anaesthetists are turning to regional analgesia for anterior abdominal wall     surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound     guidance.      The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in     post operative period of abdominoplasty.   "
128379|NCT01604681|"     The purpose of this study is to evaluate the effect of supplementation with flaxseed oil     combined with a nutritional counseling in reducing cardiovascular risk factors in     homocysteine , biomarkers of inflammation, oxidative stress, improving quality of life and     cognitive decline in hypertensive and dyslipidemic genotyped for the C677T and A1298C     polymorphisms of methylenetetrahydrofolate reductase gene.   "
128380|NCT01604668|"     There is no study hypothesis. The purpose of this study is to compare the accuracy of the: 1)     SpHb (Radical 7 Pulse Co-Oximetry with SpHb™) RevF sensor (currently marketed), 2) the SpHb     RevG sensor (a new, limited release version), and 3) the Pronto-7 sensor (currently marketed     version) in patients undergoing spine surgery.   "
128381|NCT01604655|"     The purpose of this study is to determine the best initial test in patients admitted to the     hospital complaining of chest pain.   "
128407|NCT01604317|"     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation     care will reduce the incidence of hypothermia in preterm/low birth weight and full term     infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low     birth weight infant with or without plastic head cover used during resuscitation.   "
128385|NCT01604603|"     Background: Menstrual disturbance is the major complain in reproductive age women, the     clinical and biochemical characteristics of women with different menstrual disturbance had     not been well-understood. Objective: To study the clinical and biochemical characteristics of     women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method: Retrospective     study, medical records reviewed in patients who visited to outpatient clinic of Reproductive     Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1 to 2011 Nov. 31.     Including criteria: Patients had sufficient medical records (anthropometric, endocrine,     metabolic, lipid parameters) and age less than 45. Excluding criteria: (1) Women who     experienced menarche <3 years before the beginning of the study; (2) Women who received     hormones or drugs for major medical diseases; (3) Women who presented ovarian cysts or     ovarian tumors, uterine abnormality; (4) Women who were >45 years old.   "
128386|NCT01604590|"     This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is     being treated with bevacizumab. This study will use a new MRI technique to compare the images     of blood vessels and tumor structure to the effectiveness of bevacizumab.   "
128387|NCT01604577|"     The primary research goals of this application are to characterize social factors including     health literacy and numeracy skills of CKD patients and examine associations with knowledge,     self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an     efficient interactive educational intervention to facilitate patient-provider communication.     The investigators will accomplish these goals by executing a cluster-randomized controlled     trial and performing detailed analysis of baseline measures. The specific aims of this study     are:      Specific Aim 1: Determine the association of social factors with patient kidney knowledge,     self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to     advanced CKD.      Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated     with older age, non-white race, fewer years of education, lower socioeconomic (income)     status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with     medication and diet self-care recommendations. Low literacy/numeracy is also associated with     higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance.      Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used     cooperatively by physicians and patients to improve self-care and outcomes in CKD.      Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool     will be feasible and associated with higher patient kidney knowledge, self-efficacy of     self-care and greater adherence to medication and nutrition recommendations compared to usual     care.   "
128388|NCT01604564|"     The purpose of this registry is to collect information about patients in which a pouch has     been created to improve in the future the quality of the surgery of the pouch.   "
128389|NCT01604551|"     Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell     stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with     emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been     characterized during septic shock and may contribute to dissemination of pro-inflammatory and     procoagulant mediators. This is a prospective observational study of circulating MPs and     blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU     at baseline (D1), D2, D3, D4 and D7.   "
128390|NCT01604538|"     RAZIONALE      Pulmonary embolism is a complex disease, with a highly variable clincal presentation.     Diagnosis starts with clinical probability assessment mainly based on medical history and     rapidly available clinical data. Pulmonary embolism can be managed by emergency department,     cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical     management can varies based on the attitude of the attending physician.      Diagnosis is a crucial point as it can influence short term mortality.      OBJECTIVE      The registry has 3 main objectives:        1. educational objective,        2. improvement in the knowledge of epidemiology, management and outcome of acute pulmonary          embolism in Italy        3. scientific objective   "
128391|NCT01604525|"     The RealU2 is a randomized controlled trial to determine the efficacy of an online health and     wellness program for young adults with the addition of individualized peer health coaching.   "
128392|NCT01604512|"     This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation     injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the     tumor cells are actively growing. The investigators will do these two tests and see which one     is better.      Optional Second MRI Perfusion      Patients will remain on study until the completion of either the MRI perfusion or PET/CT that     are within 12 weeks of each other. After one of these scans, the patient will have no active     interventions and will be off study.      The investigators may ask the patient to undergo a second MRI perfusion scan. They are     testing this second scan to see how well it works. It can cover the entire brain. It takes     about an 5 extra minutes in the scanner. If they decide to undergo this second scan, they     will divide the usual IV contrast dose into two parts. The patient will not receive extra IV     contrast for this second scan. This second scan is optional.      Off study: Patients will remain on study until the completion of either the MRI perfusion or     PET/CT that are within 12 weeks of each other. After one of these scans, the patient will     have no active interventions and will be off study. Patients will obtain a standard of care     brain MRI scan about every 2-3 months. These MRI scans will be used to track disease     progression.   "
128393|NCT01604499|"     This study builds on the framework of a previously implemented color-coded food labeling     intervention in a hospital cafeteria by testing the incremental effectiveness of providing     employees with individual feedback and incentives for increasing healthy purchases in a 3-arm     randomized controlled trial. The investigators hypothesize that employees assigned to receive     feedback will increase healthy purchases more than employees who receive no contact and that     employees who receive feedback plus incentives will increase healthy purchases more than     those who receive feedback alone.   "
128408|NCT01604304|"     Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave     lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature,     the two procedures are available to treat these stones with a good stone free rate. There is     no prospective randomized study comparing these two treatments. Our study will define with a     good level of evidence which technique is the best with regard to the stone free rate,     secondary procedure rate and adverse effect.   "
128394|NCT01604486|"     There is a sharp rise in the rate of coronary heart disease diagnoses and chest pain     consultations in the 90 days before a first heart attack. There is some evidence that chest     pain and angina symptoms in this period have a beneficial effect on heart attack outcomes in     hospital and shortly after discharge. However, the available evidence is lacking in three key     areas. First it is based on a retrospective patient report of symptoms after the heart attack     has occurred; this means that patients are required to survive their heart attack and may     make errors when reporting prior symptoms. Second, evidence for an effect on longer term     outcomes, and coronary outcomes in particular (e.g. coronary death, further heart attacks)     are unknown. Third, there is conflicting evidence that these effects might differ by age, in     men and women, and according to treatment in hospital.      The investigators hope to address the limitations in the evidence by performing a large,     prospective study of the occurrence, timing and effect of different types of symptoms and     disease diagnoses occurring before heart attack.      The investigators hypothesise that prospectively collected, clinical measures of chest pain     symptoms and cardiovascular diagnoses in primary care will have a beneficial effect on short     term coronary mortality and may have a beneficial effect on longer term coronary outcomes.   "
128395|NCT01604473|"     An arterio-venous fistula is a surgical procedure that supports access for people undergoing     hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to     better understand the factors that contribute to the successful maturation of an     arterio-venous fistula. A primary aim of this study is to see if endothelial function (the     biochemical events initiated by cells lining the arteries) is associated with successful     maturation. Other aims include determining if pro-inflammatory markers in the blood or     evidence of gene expression are associated with successful maturation.   "
128396|NCT01604460|"     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation     care will reduce the incidence of hypothermia in preterm/low birth weight and full term     infants when compared to routine WHO thermoregulation care alone. Part V is comparing     standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso     wrap in full term infants from resuscitation to one hour after birth.   "
128397|NCT01604447|"     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation     care will reduce the incidence of hypothermia in preterm/low birth weight and full term     infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of     a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following     removal from their incubator to assist with temperature regulation.   "
128398|NCT01604434|"     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation     care will reduce the incidence of hypothermia in preterm/low birth weight and full term     infants when compared to routine WHO thermoregulation care alone. Part III is for preterm/low     birth weight infants with or without a plastic torso wrap during the first hour after birth     to assist with temperature regulation during placement in an incubator.   "
128399|NCT01604421|"     The overall hypothesis is that plastic bags used in combination with WHO thermoregulation     care will reduce the incidence of hypothermia in preterm/low birth weight and full term     infants when compared to routine WHO thermoregulation care alone. Part II is for preterm/low     birth weight infant with or without plastic head cover used from 1 hour after birth until     discharge or 24 hours after birth to assist with temperature regulation.   "
128400|NCT01604408|"     LY2495655 is an investigational drug being tested for muscle wasting. Muscle wasting includes     shrinking of the muscle and weakness. This can occur when a muscle is no longer as active as     usual. When muscles are no longer in use, they become weaker.   "
128401|NCT01604395|"     The purpose of this study is to evaluate the long-term safety and effectiveness of growth     hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS     (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS     (Idiopathic Short Stature).   "
128402|NCT01604382|"     Patients undergoing elective total knee arthroplasty are randomized to either intrathecal     anesthesia, wound infiltration with local anesthetics and standardized postoperative care (NA     = neuraxial anesthesia) or general anesthesia, intraoperative glucocorticoids with     accelerated postoperative care principles (GA). The study hypothesis is that GA would reduce     length-of-hospital stay. Outcome variables are postoperative nausea and vomiting,     mobilization rate, pain, requirement of analgesics, and length-of-hospital stay.   "
128403|NCT01604369|"     The hypothesis of the present study is to evaluate cryoablation(cooling of the tissue) as     standard therapy of common atrial flutter,focusing on efficacy, feasibility, procedure time,     and patient content.      The purpose of this study is to determine whether cryoablation, performed only by operators     experienced in cryothermic ablation is effective and safe in the treatment of atrial flutter.   "
128404|NCT01604356|"     Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt     to slow, halt or reverse the retinal disease process, and claim success with some approaches     such as acupuncture, but this potential treatment has not been put to the test of objective,     rigorous scientific study conducted in western society. In this pilot study, the     investigators aim to evaluate an acupuncture treatment tailored to the RP population for its     feasibility to improve visual function, specifically visual field and dark adaptation. The     study results may provide a basis for eye care providers' recommendations to RP patients     regarding whether to consider acupuncture as a potential treatment modality. If our     hypotheses regarding improvements in vision beyond typical test variability are supported,     our future research goals include the conduct of a larger clinical trial with involving     randomization and a placebo control for acupuncture in RP.   "
128405|NCT01604343|"     The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction     of the signs and symptoms of rheumatoid arthritis (RA) and inhibition of radiographic     progression in patients with active RA who are unresponsive to treatment with     disease-modifying antirheumatic drugs (DMARD).   "
128406|NCT01604330|"     The main objective of this study is to show the effectiveness to a year of baclofen compared     to placebo, on the proportion of patients with a low risk alcohol consumption or no,     according to the WHO standards.   "
141838|NCT01427933|"     This is a study to compare the antitumor activity of ramucirumab (IMC-1121B) and eribulin     together versus eribulin alone, in participants with locally recurrent or metastatic breast     cancer.   "
128409|NCT01604291|"     This multi-center, observational study will evaluate the efficacy and safety of dual and     triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis     C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin     plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to     24 weeks of follow-up.   "
128410|NCT01604278|"     This study assessed the efficacy, safety and tolerability of the co-administration of NVA237     plus indacaterol taken once daily versus indacaterol taken once daily in patients with     moderate to severe Chronic Obstructive Pulmonary Disease.   "
128411|NCT01604265|"     To investigate the ability of Sativex to relieve central neuropathic pain in multiple     sclerosis subjects.   "
128412|NCT01604252|"     This multi-center, prospective, observational cohort study will evaluate the effectiveness,     safety and utilization of treatments in patients with advanced basal cell carcinoma and basal     cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum of 8     years, including 3 years for patient recruitment and 5 years follow-up.   "
128413|NCT01604239|"     This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events     than celecoxib in subjects with osteoarthritis.   "
128414|NCT01604226|"     The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle     relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to     be influenced mainly by propofol and remifentanil infusion dose. As such, the investigators     postulate that the BIS value could be predicted by the estimated effects-site concentration     of propofol and remifentanil, and try to establish a multiple linear regression model for     predicting BIS value.   "
128415|NCT01604213|"     The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is     associated with clinically significant reductions in biological markers of inflammation,     pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a     population of diabetic patients with coronary artery disease who undergo cardiac     rehabilitation.      The pre-specified established biological markers of inflammation, pro-thrombogenicity, and     atherosclerosis will include: interleukin-6 (IL-6 - primary biological marker), hs-CRP,     platelet reactivity testing, MMP-9, Interleukin 1 beta (IL-1 beta) and adiponectin levels.   "
128416|NCT01604200|"     20% of Canadians are hypertensive with approximately 200,000 new cases each year. Early     detection of hypertension affects outcomes, reducing the risk for heart attack, stroke,     kidney disease, and dementia. Screening strategies are required to identify the more than one     third of Canadians with unrolled high blood pressure, in particular, younger men unaware of     their condition, women over sixty years old, and underserved groups.      A collaborative practice model linking dentists to other healthcare providers in a reporting     network is a promising model for hypertension detection and management. There are 20,129     licensed dentists in Canada who graduate with the ability to measure blood pressure, and 74%     of the population visits a dentist each year. This represents an opportunity, but information     is required on Dental attitudes toward screening for hypertension before attempting to     initiate a screening model. To engage dentists in hypertension detection requires an     understanding of the practice environment and the factors that shape their beliefs, attitudes     and behaviours regarding routine hypertension screening in their practices.   "
128417|NCT01604187|"     Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the     patient. The pain associated with the procedure is not caused by the insertion of the scope     but from inflating of the colon in order to do the inspection. It has been shown that     colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients     feel discomfort during the procedure. Factors predicting a painful colonoscopy are     female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy     (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are     associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia     are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an     opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by     using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not     significantly decrease pain intensity or endoscopist's evaluation of colonoscopy (Grossi et     al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some     sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure;     drug administration, need for pulse oximetry monitoring and the need for follow-up after the     procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that     low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al.     2009).      Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal     sublingual formulation of fentanyl has been developed to further improve the management of     pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed     under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by     the body through the mucous membrane. After administration of buccal fentanyl maximum plasma     drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl     concentrations versus time following buccal and sublingual administration are very similar     (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the     tongue at the deepest part. Sublingual administration is an easy and non-invasive method of     pain treatment for the patient coming to colonoscopy done as an office based procedure. Other     advantages compared to invasive methods are improved comfort of patients and no need for     intravenous access because of pain relief. Before, it has been used in the management of     breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and     well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use     of transmucosal tablet for colonoscopy patients is a quite new approach.   "
128418|NCT01604174|"     The purpose of this clinical trial is to compare the effectiveness of a new interactive     virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation     of patients after total knee arthroplasty.   "
128419|NCT01604161|"     This study is conducted in Japan. The aim of this study is to collect information about the     efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature     with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature     with Turner Syndrome where epiphysial discs are not closed.   "
128420|NCT01604148|"     Persistent detrusor overactivity (DO) after transurethral prostatectomy results in     symptomatic failure in more than one third of the patients. Storage symptoms are major     complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate     (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction     (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in     conjunction with the prescription of the anticholinergic drugs.   "
128421|NCT01604135|"     The purpose of this study is to determine whether corneal collagen crosslinking is effective     in the treatment of progressive keratoconus.   "
128422|NCT01604122|"     This study is an online (web-based) or paper-based survey for patients with transthyretin     familial amyloidosis polyneuropathy (TTR-FAP) and caregivers. The results will be used to     describe the emotional, physical, and financial impact of having TTR-FAP or caring for     someone who has the disease.   "
128424|NCT01604096|"     Use of information campaigns and educational interventions directed to citizens and supported     by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by     several studies with conflicting results. These interventions are potentially relevant,     favouring the reduction of unnecessary use of medicines and related risks. Several studies     have specifically evaluated the promotion of the appropriate use of antibiotics in adults and     children, with variable results. A controlled study has been proposed to evaluate the     feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic     prescription by increasing awareness on risks of their unnecessary use.      Information has been provided to citizens through several media (posters, local TV, radio and     newspapers, video terminals, websites of Local Health Authorities). Brochures with     information on expected benefits and risks of antibiotics has also been available, either     with direct access in waiting rooms and pharmacies or handed out and mediated by doctors.     Physicians and pharmacists received specific data on local antibiotic resistance. A small     group of representative doctors have also actively participated in defining the campaign key     messages. A sample of general practitioners and paediatricians have been trained in patient     counselling strategies.      The information campaign has been implemented in two Provinces of Emilia-Romagna during the     fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of     antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be     compared versus other areas in the same Region. Knowledge and attitudes of the general     population will be evaluated through a phone and internet survey on a representative sample.      This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.   "
128425|NCT01604083|"     The aim of the ETPOS study is to describe differences in transfusion habits throughout Europe     and to correlate these habits to perioperative outcome parameters. Special focus is put on     the number of PRBCs (packed red blood cells) transfused and the ratio of PRBCs to other blood     products or coagulation factors in the operating room. Furthermore the motivation of     physicians to transfuse PRBC and blood products in the operating room will be investigated.   "
128426|NCT01604070|"     Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises     flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension     of the metatarsophalangeal (MTP).      Etiologies of hammertoe deformity include a foot in which the second ray is longer than the     first, MTP synovitis and instability, inflammatory arthropathies, neuromuscular conditions,     and ill-fitting shoe wear. When a foot's second ray is longer than the first and shoe wear     does not fit correctly, flexion of the PIP joint occurs to accommodate the shoe. This length     difference also causes MTP synovitis to develop from overuse of the second MTP joint.     Attenuation of the collateral ligaments and plantar plate result, and the MTP joint     hyperextends and may even progress to dorsal subluxation or dislocation (see image below).     Rheumatoid arthritis causes hammertoe deformity by progressive MTP joint destruction, leading     to MTP joint subluxation and dislocation.      With all 3 of these etiologies, the extensor digitorum longus (EDL) tendon gradually loses     mechanical advantage at the PIP joint, as does the flexor digitorum longus (FDL) tendon at     the MTP joint. The intrinsic muscles fire and sublux dorsally, as the MTP hyperextends. They     now extend the MTP joint and flex the PIP joint, as opposed to their usual functions of     flexing the MTP joint and extending the PIP joint.   "
128427|NCT01604057|"     This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a     biomarker of bone formation in postmenopausal women with low bone mass.   "
128428|NCT01604044|"     This study evaluates the effects of different therapies in ovulation induction in     Intrauterine Insemination Cycles.   "
128429|NCT01604031|"     This is a research study to determine the safety and effectiveness of using special cells     that may make the subject's immune system fight their chronic lymphocytic leukemia (CLL) in     combination with a drug called Lenalidomide.      To do this, the investigators will put a special gene into cancer cells that have been taken     from the subject. This will be done in the laboratory. This gene will make the cells produce     interleukin 2 (IL-2), which is a natural substance that may help the subject's immune system     kill cancer cells. Additionally, the investigators will stimulate the cancer cells with     normal embryonic fibroblasts (cells that develop into normal connective tissues in the body)     so that they will make another natural protein called CD40 ligand (CD40L). Some of these     cells will then be put back into the subject's body with the goal that they will act like a     vaccine and stimulate the immune system to attack the CLL cells.      The investigators have already conducted a study similar to this in other subjects with CLL.     In those subjects the investigators saw some changes in the subject's immune system that     might indicate that the modified cells were helping their immune system fight the cancer.     However, in most of the subjects this change in the immune system went away after the     injections were stopped. The investigators think that this may be due to a high level of     cells called T regulatory cells. T regulatory cells are part of the immune system and prevent     excessive reactions from other cells in the body. Studies have shown that reducing T     regulatory cells allows the body to fight the cancer for a longer period of time.      Recent studies have shown that using Lenalidomide helps the body reduce T regulatory cells.     Using Lenalidomide along with the injections (shots) might help the body fight the cancer for     a longer period of time. Lenalidomide is also called Revlimid.      In this study the investigators want to see if they can make the change in the immune system     last longer by giving Lenalidomide before and at the same time as the vaccine. The     investigators hope that this might produce a better response directed at the CLL cells.     Subjects will receive injections for about a year   "
128430|NCT01604018|"     Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic     rhinoconjunctivitis and/or asthma.      The purpose of this optional observational follow-on study is to further evaluate     rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who     completed all dosing visits in study CP005 and all visits in study CP005A approximately two     years after the start of treatment.   "
128431|NCT01604005|"     The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT     radiotherapy is effective in preventing or delaying the onset of chest nodules in patients     with Mesothelioma.   "
128432|NCT01603992|"     Background:      - Marijuana is the most widely used illicit drug in the world, yet relatively little is known     about users who try to quit without formal treatment ( spontaneous quitting). Studies have     suggested that there are some common strategies that many individuals use in spontaneous     quitting, such as changing one s lifestyle or identity, reminding oneself of negative     consequences, support from family and friends, and religion. However, more research is needed     to determine potential treatment strategies for marijuana use.      Objectives:        -  To identify strategies used to help with marijuana quitting among non-treatment seeking          adult marijuana users.        -  To identify withdrawal symptoms experienced during marijuana quitting and their          relationship to the quitting strategies used and the outcome of the quit attempt.        -  To evaluate whether subgroups of marijuana users differ in their experience of marijuana          quitting.      Eligibility:      - Individuals at least 18 years of age who have made at least one attempt to quit marijuana     use.      Design:        -  The study will consist of one visit of approximately 1 to 2 hours.        -  Participants will fill out three questionnaires. The questionnaires have different types          of questions, and will ask about background and lifestyle, marijuana use and craving          patterns and behaviors, and difficulties in previous attempts to quit using marijuana.   "
128454|NCT01603706|"     The purpose of this study is to evaluate the use of radial strain imaging using speckle     tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy     (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT     indication. Thus assessing the value of lead localization determined by radial strain imaging     in a prospective, randomized manner.   "
128433|NCT01603979|"     This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate     the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD)     and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and     preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once     every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid     tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated     in an expansion cohort at the RP2D for safety and anti-tumor activity.   "
128434|NCT01603966|"     This study is to determine whether the AggreGuide platelet aggregometer can discern the     effect of low dose aspirin on subjects platelet aggregation using arachidonic acid as the     agonist.   "
128435|NCT01603953|"     Protein-energy malnutrition and muscle wasting are a common finding among patients with liver     cirrhosis. Its prevalence may range from 50-90% depending on the methods used for nutritional     assessment. Even stable cirrhotic patients referred as Child A have muscle depletion and the     majority of patients classified as Child C have significant depletion. Malnutrition has been     shown to be related to several complications of cirrhosis      Despite the importance of nutritional status in patient's outcome, there is no gold standard     for nutritional assessment. Traditional techniques used in healthy subjects to assess     nutritional status cannot be used in cirrhotic patients due especially to ascites and     peripheral edema, and altered rates of biochemical markers due to liver failure.      Bioelectrical impedance vector analysis has emerged as a useful method to assess body     composition and nutritional status especially in patients at the extremes of body weight     (fluid overload, excess of adipose tissue, etc.).      The aim of this study is to evaluate whether malnutrition assessed by bioelectrical impedance     vector analysis is related to the development of hepatic encephalopathy   "
128436|NCT01603940|"     The purpose of this study is to compare losartan and benazepril in diabetic patients whose     high blood pressure is not controlled by amlodipine and its relationship to statin current     use.   "
128437|NCT01603927|"     Bowel cancer is a common disorder in the UK. Most cancers happen when a type of polyp, called     an adenoma, becomes cancerous. Polyps are growths in the large bowel that can be cancerous,     non-cancerous, or pre-cancerous (adenoma). Polyps are most commonly detected during     colonoscopy (camera test of the lower bowel). The removal of adenomas has been shown to     reduce the subsequent risk of bowel cancer. Current practice is that all polyps are removed     or biopsied to allow a laboratory diagnosis (histology). This is important as it influences     if and when patients require follow-up colonoscopies, known as the surveillance interval.     Patients with only non-cancerous polyps do not need surveillance.      A new blue light technology, called narrow band imaging (NBI), used during colonoscopy can     help colonoscopists (doctor or nurse performing the procedure)differentiate between polyp     types during colonoscopy. NBI is currently available in a large number of UK endoscopy units     however is variably used. Studies from 'expert' centres have demonstrated that NBI allows     accurate optical diagnosis of colonic polyps. Benefits of optical diagnosis include avoiding     removal of non-cancerous polyps and an immediate (on the day) diagnosis for the patient     including the surveillance interval.      The primary aim of this study is to evaluate the accuracy with which colonoscopists assess     the required surveillance interval using optical diagnosis when compared with histology in     non-expert centres. The investigators will invite 2500 patients, who have been referred for     colonoscopy, to participate. Patients will undergo a routine colonoscopy the only addition     being the use of NBI during the procedure. Colonoscopists will provide an optical diagnosis     at the time of colonoscopy in addition to polyp removal or biopsy.      The investigators will compare surveillance intervals provided using optical diagnosis with     the diagnosis from histology and thereby the accuracy with which colonoscopists can use the     technology. The investigators will also calculate the cost savings to the NHS.   "
128438|NCT01603914|"     The aim of this project is to answer the following questions:      To determine the incidence of catheter related bacteremia (CRB) with three strategies of     central venous catheter exchange in critically ill adult patients with major burn and to     determine the regimen that will minimize the risk of bacteremia.      To determine the incidence rate of catheter colonization in adult patients with major burns.      The scientific knowledge to be acquired through this project is of likely benefit to the care     of critically ill patients with burns injury as follows:      The intention is to improve the outcomes in critically ill patients by minimizing one of the     most frequent causes of infection in the Burn Intensive Care Unit, those from central venous     catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease     costs, and decrease mortality.   "
128439|NCT01603901|"     Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard     technology for treatment of various chronic and acute wounds. The investigators plan to     evaluate the efficacy and ease of use of this device.   "
128440|NCT01603888|"     B-type natriuretic Peptide (BNP) is a cardiac hormone secreted from the cardiac myocytes in     response to volume load. Plasma levels of BNP, as measured by immunoassay methods, are     elevated in patients with heart diseases. However, the biological effects of BNP are blunted     in heart failure and other cardiac conditions. Moreover, the peptide levels are also elevated     in non cardiac conditions such as the neonatal period, sepsis and renal failure. Recent     investigations suggest alteration of the peptide molecular structure in heart failure. These     alterations may explain, at least partially, the reduced biological activities of BNP in     heart failure.      Immunoreactive BNP and NT-proBNP have been identified in human urine. It has been suggested     that urinary BNP correlates with plasma BNP, and may serve as a non-invasive measure for this     cardiac marker. It is unclear what BNP fractions are cleared in the urine in health and     disease.      The aim of the proposed studies is to elucidate precisely the molecular form of BNP in     various disease and specific physiological states in plasma and urine of infants and     children.   "
128441|NCT01603875|"     Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies     Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.      After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell     Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5     IU/ml or more.      And Simulated post-exposure rabies booster vaccination with a new Chromatographically     Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies     vaccine.      After the simulated post-exposure rabies booster vaccination with a new Chromatographically     Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients     on day 14 after the booster are 0.5 IU/ml or more.   "
128483|NCT01603329|"     The goal of this project is to increase patient adherence to medication using communications     and incentives for physicians. The investigators are partnering with a health insurance     company, Humana Inc, to design and implement an incentives program for physicians whose     patients increase their medication adherence for oral diabetes medication, hypertension (ACEI     or ARB) medication, and/or cholesterol (statins) medication. The investigators will use     behavioral economics to explore the best way to communicate the incentives to the physicians.   "
128442|NCT01603862|"     Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently     there is no cure however early diagnosis and effective treatment offers hope for reducing the     impact. Dementia sufferers require care due to physical disability, cognitive deficits,     social isolation and emotional symptoms (depression). Delaying the onset of dementia will     improve quality of life for patients and reduce the cost of residential care (£42 000 per     person per year).      People with mild cognitive impairment (MCI) are at high risk of developing dementia. They     have impaired cognitive abilities, such as memory, but still manage their everyday     activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6     years after diagnosis.      Regular physical activities and performing a variety of cognitive activities reduce the risk     of dementia and improves abilities and quality of life in healthy people. Therefore a     combination of these activities may reduce the risk of developing dementia in MCI. The     investigators want to see if they can develop a program which combines these activities in a     fun and social way that gets people active and keeps them active. The aims are to improve     fitness, cognition and quality of life. The investigators plan to use computers and the     internet to help with the activities and to make them available to people who are isolated.     Physical activity will involve walking from home, cognitive activities will be computer based     games and puzzles and socialising will involve regular varied group-based activities.     Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a     26 week program. They will then be followed up yearly to monitor their progress. The main     outcome of the study is engagement in the activities. The investigators will also measure     fitness, cognition, quality of life and conversion to dementia.   "
128443|NCT01603849|"     Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer     (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally     advanced or metastatic disease. Important to mention the number of patients that progress or     recur in central nervous system (CNS). It has been reported that patients with     adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are     in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with     prophylactic cranial irradiation (PCI) is the standard of care in patients without     progression after locoregional or systemic treatment because the proven benefit in overall     survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to     prove any survival benefit, only in CNS PFS, probably because there is no trial, to our     knowledge, of PCI in NSCLC that include only the specific group of patients considered in     high risk of developing brain metastasis.   "
128444|NCT01603836|"     The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with     allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing.     Allograft by itself is not an effective material as a posterior onlay graft for the PLF in     adult surgery.   "
128445|NCT01603823|"     The purpose of this study is to investigate the morphological and angiological retinal     changes in different macular diseases.   "
128446|NCT01603810|"     Optical coherence tomography (OCT) is an imaging technique which shows the internal structure     of living tissue (in vivo). It is safe, quick and painless to perform, and does not damage     the tissue in any way. Recent advances in the technology mean that it can now be used to take     images of the internal structure of the skin. This is useful because certain conditions, such     as skin cancers, alter this structure. At present a suspected skin cancer is identified by     taking a sample (a biopsy) which is analysed under the microscope to confirm the diagnosis.     The cancer is then excised including a margin of apparently healthy-looking skin around it to     ensure that the entirety of the tumour is removed. The excised tumour is then analysed again     under a microscope to confirm that it was indeed completely removed (histology), after which     a further operation is required to repair the defect.      The purpose of this study is to evaluate OCT imaging of a particular type of skin cancer     called a basal cell carcinoma (BCC), and in particular BCCs affecting the skin around the     eyes (periocular). The study will compare the ability of OCT to define the margin of the BCC     with the current 'gold standard' of histology. OCT could potentially improve the     investigators ability to define the margins of the tumour before surgery and become a guide     for minimally invasive surgery. The preservation of healthy tissue represents a priority,     particularly in the area of the skin surrounding the eye.   "
128447|NCT01603797|"     The aim of this study was to investigate if guided internet-delivered acceptance and     commitment therapy (ACT)would help chronic pain patients.   "
128448|NCT01603784|"     The purpose of this randomized, controlled, prospective study is to evaluate the benefits of     combining aerobic exercise with cognitive training for optimizing cognitive function. The     study will enroll 109 men and women, age 55-75 years who are in stable health and without     contraindications to exercise or evidence of dementia or cognitive impairment. Individuals     will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health     Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and     Home Exercise and Health Education. Participants will undergo measurements of cognitive     function, physical performance, and complete questionaires about daily activities, physical     activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after     baseline.   "
128449|NCT01603771|"     The goal of this pilot study is to evaluate whether healthy, sedentary older adults have     increased activation of specific brain areas, in response to exercise and cognitive training,     in comparison to a control group, and whether improvements in psychometric test performance     are related to increased activation of brain networks. Participants, between age 55-75 years     will be recruited from an ongoing study of exercise and cognitive training, to undergo Blood     Oxygen Level Dependent (BOLD) functional magnetic imaging (fcMRI).   "
128450|NCT01603758|"     The underlying hypothesis is that whole body cholesterol - including cholesterol present in     tissues that cannot be measured by standard blood tests - is related to heart disease risk.     Endogenous cholesterol will be labeled with an intravenous infusion of one type of     cholesterol tracer and dietary cholesterol will be labeled with another. These tracers will     be used to measure how fast cholesterol is synthesized and excreted using mass spectrometry     to distinguish the tracers. Data will be related to circulating biomarkers (blood tests) and     to the thickness of the lining of the carotid artery. The effect of the drug ezetimibe on     these processes will also be determined. Successful completion of this study will give us     more knowledge about cholesterol metabolism that may be useful in designing new drugs and     treatments for patients with heart disease, especially those that are already receiving     maximum amounts of current medications.   "
128451|NCT01603745|"     Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as     insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk     for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia,     hypertension, oxidative stress and inflammation are associated with PCOS. The investigators     want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in     PCOS.   "
128455|NCT01603693|"     Amongst the consequences of missing teeth are change of appearance and difficulties in     mastication and speech. Dental implants in the maxilla or mandible provide a common treatment     modality by offering anchorage to fixed or removable fixtures. In many cases, the lack of     teeth is accompanied by lack of appropriate bone volume in the desired area for dental     implant placement. Possible causes for this lack of sufficient bone volume are varied and     include earlier bone atrophy, traumatic tooth extraction and bone resorption due to     periodontal disease. In such cases, dental implant placement is preceded by alveolar bone     augmentation . Guided Bone Regeneration (GBR) is a common bone augmentation technique in     which a bulk of bone substitute is placed in the area which needs more volume before placing     a dental implant. The bone substitute is covered with an inert membrane and may provide a     scaffold and encourage cells from the patient to reach the area and build new bone volume. A     common bone substitute in use for that matter is Deproteinized bovine bone mineral (DBBM)     which resembles human bone and helps encourage new bone formation. On the contrary its     structural stability during placement and early healing is low. Bi-Phasic Calcium-Sulphate is     another common bone substitute with easy handling properties and good structural stability     during early healing. Its replacement by natural bone contributes to the augmentation     process. Although DBBM efficacy in GBR process has been investigated, using DBBM in     combination with bi-phasic calcium-sulphate as a binding material during GBR was not     examined. This prospective study will examine augmented bone quality and quantity following a     GBR procedure with common approved bone substitutes: DBBM (Bio-Oss, Geistlich) alone or in a     combination with bi-phasic Calcium-sulphate (BondBone, Augma). The GBR procedures will     precede dental implant placement as custom. The quality and quantity of the new formed bone     will be assessed by a C.T (computerized tomography) which is done routinely before dental     implant placement and by further analyses of bone residues which will follow drilling the     dental implant placement site while preparing it (as common).   "
128456|NCT01603680|"     1. Evaluation of the efficacy of the circumferential versus non circumferential          distribution of mepivacaine around the median and ulnar nerves.        2. Evaluation the onset of action of mepivacaine in circumferential versus non          circumferential distribution around the median and ulnar nerves.        3. Spread of mepivacaine after injection guided by ultrasonography.        4. Complications of both anesthetic techniques in postoperative time.   "
128457|NCT01603667|"     The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg     versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an     acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.      The secondary objectives are as follows:        -  To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel          Index (BI) score at Day 90.        -  To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent          stroke, cardiovascular events and death of all causes.        -  To evaluate the safety of PG2 Injection 500 mg treatment   "
128458|NCT01603654|"     Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon     preparation affects the quality of colon cleansing. The study is aimed at comparing the     efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and     low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor     bowel preparation.   "
128459|NCT01603641|"     This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the     treatment of pediatric lower limb spasticity.   "
128460|NCT01603628|"     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in     pediatric patients with lower limb spasticity.   "
128461|NCT01603615|"     This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the     treatment of pediatric upper limb spasticity.   "
128462|NCT01603602|"     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in     pediatric patients with upper limb spasticity.   "
128463|NCT01603589|"     The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC)     extracorporeal circulation on perfusion characteristics and remote end-organ protection     (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting     (CABG).   "
128464|NCT01603576|"     This study will be an initial proof of concept study, to evaluate safety and efficacy of a     prototype suprachoroidal retinal implant   "
128465|NCT01603563|"     The aim of this R34 study is to develop and test the feasibility of a Stepped Care     intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus     on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral     Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized     controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard     Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures,     treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this     pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al.,     2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the     effectiveness of SC-TF-CBT for early childhood PTSD.   "
128466|NCT01603550|"     This proposed laboratory study will extend previous findings on relationships between     cognitive function and nutritional status to conditions that more closely resemble military     operations where aerobic exercise, inadequate nutritional intake and sleep deprivation     combine to degrade cognitive function. The investigators will examine cognitive function,     brain activity and glucose levels in volunteers who are calorie-deprived, performing high     workload cognitive tests, exercising and, in one arm of the study, are sleep-deprived for     approximately 48 hours. A comprehensive cognitive test battery will be repeatedly     administered and several cognitive tests will be administered when volunteers are exercising.     Interstitial glucose levels will be assessed and whole body nitrogen utilization determined.     The effects of energy restriction and the physiological basis of the relationship between     peripheral glucose levels and cognitive function will be examined using a state-of-the-art     imaging technology, functional Magnetic Resonance Imaging (fMRI). This technique will allow     any key brain regions affected by caloric deprivation to be identified.   "
128480|NCT01603368|"     Mortality and incidence of severe complications is still high among extremely premature     infants. Common causes of severe complications in this population are poor nutrition,     necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common     problem resulting in prolonged need for intravenous lines and poor nutrition.      The aim of the study is to evaluate whether supplementation with the probiotic bacterium     Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight     increases feeding tolerance to breast milk and thereby improves nutrition, increases growth     and reduces serious complications and mortality in this population. Beyond this, possible     mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.   "
141865|NCT01427569|"     The purpose of this study is to determine if topical application of a hydrogel that contains     plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a     hydrogel alone.   "
128467|NCT01603537|"     Trauma is the leading cause of death among persons below 60 years of age. It is a     well-established belief that optimal treatment in the early phase after trauma has a major     impact on mortality, and the implementation of specific educational programs for trauma care     have been a widely adopted strategy aimed at improving the outcome. This strategy has high     face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support     (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the     Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital     caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of     the leading educational programs for prehospital emergency trauma care. However, the     scientific support for improved patient outcome from courses such as PHTLS and ATLS is     limited. According to a Cochrane analysis published 2010 there is no evidence to recommend     advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis     concerning ATLS gave similar results and a recent study indicated even worsened outcome after     the implementation of ATLS. An observational study in the county of Uppsala indicated reduced     mortality after the implementation of PHTLS but the estimate was uncertain due to a low     overall mortality. The aim of this study is to further investigate the association between     PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study     population. To accomplish this the investigators will use an epidemiological semi-individual     design applied to all victims of traffic injury that occurred during the implementation     period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will     be analyzed: Mortality before hospital admission, mortality within 30 days, time to death     among survivors to hospital admission and return to work among survivors to hospital     discharge.   "
128468|NCT01603524|"     This proposal outlines the design of a cluster randomized controlled trial to compare the     effectiveness of a new approach to integrating smoking cessation services into routine     interactions with patients in the primary care setting using an adaptation of the Ottawa     Model for Smoking Cessation (OMSC). The OMSC aims to systematically identify the smoking     status of all patients, provide brief cessation advice, and offer evidence-based cessation     support to those interested in embarking on a quit attempt. This study will provide important     new evidence to assist with the development of a more comprehensive cessation system in the     province of Ontario and across Canada.   "
128469|NCT01603511|"     The study will compare the rewarming effectiveness of heat donation through the head or the     torso during rewarming of mildly hypothermic subjects. Warming will be accomplished through     either forced-air warming or using a charcoal heater; both units are commonly used for     warming. The investigators hypothesize that head warming will be as, or more, effective     compared to   "
128470|NCT01603498|"     The main aim of the present study was to investigate the effect of preemptive dexamethasone     and methylprednisolone to prevent pain, swelling and limitation in mouth opening following     third molar extraction.   "
128471|NCT01603485|"     The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different     modified-release formulations of lersivirine and compare it to the PK of the     immediate-release tablet. The effect of food on the PK of one of the modified-release tablets     will also be assess along with the safety and tolerability of each treatment.   "
128472|NCT01603472|"     Parenteral nutrition (PN) is the provision of nutrients via the intravenous route. Parenteral     nutrition associated metabolic bone disease (MBD) was first described in children in the     1980s. Since then, there has been little to no research into the underlying relationship and     as a result, little evidence on which to base clinical care. In adults, MBD is associated     with increased fractures. At the Hospital for Sick children in Toronto, an intestinal failure     program has been set up since 2003. This is the only intestinal failure program in Canada and     receives country wide referrals. Most of the patients have short bowel syndrome (SBS) and     require PN for prolonged periods, or for life. About 90% of these patients have MBD, and some     have had bone fractures. An understanding of the etiology of MBD would provide information to     guide care, and prevent this condition. Funding for this area of research however is     challenging because intestinal failure requiring long term PN is a rare condition, accounting     for approximately 200 - 300 children in all of Canada. The goal of this study therefore is to     gather pilot data on markers of MBD in children on long term PN, and to compare these markers     to age and gender matched control patients who are fed by mouth or feeding tube. The     information gathered from this study will help us begin to understand what is actually     happening in the bones of children on long term PN and will form the basis for future studies     and improved clinical care.   "
128473|NCT01603459|"     The purpose of this study is to determine whether injections with increasing doses (up to 800     units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in     treating patients with spasticity on one body side due to cerebral causes.   "
128474|NCT01603446|"     MELAS patients suffer from exercise intolerance, weakness, poor vision or blindness, poor     growth, developmental delay, and deafness. They also have unique 'stroke-like' episodes     (SLEs) which are not due to blockages of large or medium arteries. These 'strokes' are     thought to be due to energy failure of very small brain blood vessels combined with energy     failure in the mitochondria (cell battery) of the brain cells, especially in the back region     of the brain in the vision centre. This leads to visual loss and paralysis. The overall goal     of this study is to better understand the mechanism of these SLEs at the level of the brain     cells and small blood vessels.   "
128475|NCT01603433|"     This is a single center, prospective, non-randomized, feasibility study for the evaluation of     safety, efficacy and performance of the Sapheon™ Closure System for the treatment of     incompetent saphenous veins.   "
128476|NCT01603420|"     The purpose of this study is to compare the effects on prostate cancer using radiation     therapy with or without chemotherapy.   "
128477|NCT01603407|"     The Finding the Optimum Regimen for Duchenne Muscular Dystrophy (FOR DMD) study will compare     three ways of giving corticosteroids to boys with Duchenne muscular dystrophy (DMD) to     determine which of the three ways increases muscle strength the most, and which causes the     fewest side effects. Using the results of this study, the investigators aim to provide     patients and families with clearer information about the best way to take these drugs.   "
128478|NCT01603394|"     The primary objective is to explore whether sensory symptom cluster analysis is useful for     predicting treatment response in Postherpetic Neuralgia.   "
128479|NCT01603381|"     The investigators intend to assess the following:        -  the efficacy of CBTi in treating insomnia during recovery,        -  does a family history of alcoholism moderate the insomnia symptoms,        -  does an improvement in insomnia lead to a decrease in impulsivity.   "
128481|NCT01603355|"     The investigators are doing this research study to see if tocilizumab (Actemra) is safe and     effective when used for severe or refractory non-infectious uveitis. Uveitis is an     inflammation of the eye that is caused by the body's immune system reacting against the eye     tissues.   "
128484|NCT01603316|"     The investigators have found that many patients getting treatment for cancer have trouble     getting enough to eat, or do not always have enough money for food. When a patient has these     problems it can lead to difficulties with completing cancer treatment. Across New York City,     there are many hospitals that offer their patients food pantry services on location. The     investigators would like to compare how food pantries within the hospital and two other food     assistance options: monthly food vouchers and weekly grocery deliveries maybe possible     solutions to this problem. The patient will be randomly assigned to one of the three     different food program groups, which means everyone has an equal chance in being in any     group, like a flip of a coin. The investigators hope to learn how to best help patients with     trouble getting food and to see if this will help with completing cancer treatment.   "
128485|NCT01603303|"     Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning     after treatment in women who are in menopause and who had breast cancer that was sensitive to     the hormone estrogen.      The goal of this study is to learn if it is possible to prevent some AI side effects,     particularly problems with vaginal dryness and pain during sexual activity. Researchers also     want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid     vaginal dryness. Researchers want to see if preventing these side effects will decrease the     number of women who stop taking AIs due to the side effects they cause.   "
128486|NCT01603290|"     The purposes of this study are to (1) explore the severity of symptom of leukemia patients     experienced before and after chemotherapy in hospital, (2) investigate the trajectories of     the fatigue and physical fitness, and their related factors, and (3) the correlation between     fatigue and physical fitness   "
128487|NCT01603277|"     This study will evaluate the safety, tolerability and efficacy of a single dose level of     KB003 in subjects with inadequately controlled asthma.   "
128488|NCT01603264|"     In this study, healthy male volunteers will receive a single intravenous administration of     either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During the     course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in     the blood, and by comparing these levels among the different administration arms of     PF-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability,     and immunologic response also will be evaluated throughout.   "
128489|NCT01603251|"     The purpose of this study is to determine the safety and impact of ivermectin, administered     as single or repeated dose, in combination with artemether-lumefantrine in reducing the     proportion of mosquitoes that survive and become infected after feeding on a blood meal from     a malaria-infected individual.   "
128490|NCT01603238|"     This was an open-label, non-randomised, single-dose study in 6 healthy male subjects.     Subjects attended a screening visit within 28 days before drug administration. Subjects were     admitted to the clinical unit on the morning of the day before dosing (Day -1) and received a     single oral administration of study drug in a fasted state on Day 1. Subjects were resident     in the clinic for up to 7 days after dosing; they could be discharged sooner if a mass     balance cumulative recovery of >95% was achieved, or if a mass balance cumulative recovery of     >90% was achieved and <1% was collected within 2 separate, consecutive 24 h periods. At     specified times during the study period, blood samples were taken and urine and faeces were     collected for PK analysis. Safety assessments were also performed.   "
128491|NCT01603225|"     This research is being done to determine whether transcranial direct current stimulation     (tDCS) can improve certain mental abilities, such as speech, language and other efforts at     communication in individuals with autism.      In this research, battery powered device is used to deliver very weak electrical current to     the surface of the scalp while participants are involved in tasks aimed at training or     measuring communicative efforts, speech, language or related cognitive functions. Our aim is     to find out whether tDCS will improve these mental abilities.   "
128492|NCT01603212|"     The goal of the Phase I part of this clinical research study is to find the highest tolerable     dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with     interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this     combination will also be studied.      The goal of Phase II is to learn if this study drug combination can help to control advanced     or metastatic melanoma.   "
128493|NCT01603199|"     Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a     progressive course that can lead to liver cirrhosis. There are few studies on dietary     management in primary biliary cirrhosis and most of them have focused on micronutrients     specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent     hyperlipidemia, but few recommendations have been made regarding a complete dietary approach.     Fiber has been proven to increase the excretion of nitrogen products and consequently reduce     its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease     endogenous catabolism in cirrhotic patients.      The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the     nutritional status of patients with primary biliary cirrhosis.   "
128494|NCT01603186|"     This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single     dose pivotal study. The purpose of this study is to assess the bioequivalence between Test     Product and the corresponding Reference Product under fed condition in normal, healthy,     adult, human subjects.   "
128495|NCT01603173|"     This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single     dose pivotal study. The purpose of this study is to assess the bioequivalence between Test     Product and the corresponding Reference Product under fasting condition in normal, healthy,     adult, human subjects.   "
128496|NCT01603160|"     The objective of this study is to design, implement and test quality improvement measures to     improve the care of adults with sickle cell disease in the emergency department.   "
128497|NCT01603147|"     The primary objective is to determine the safety and tolerability of single, ascending     intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse     event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a,     randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered     ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive     a single dose of ch-mAb7F9 or placebo (saline).   "
128500|NCT01603108|"     The purpose of this study is to determine if the administration of a poorly-absorbable     antibiotic (rifaximin) for the first three months after liver transplant will reduce the     amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent     hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that     comes from the bacteria in intestines and may cause scarring in the liver.      Approximately 60 subjects will participate in this study. Subjects will be part of the study     for approximately 1 year post transplant.   "
128501|NCT01603095|"     Multicenter, multinational study to collect consistent baseline growth measurements on     pediatric patients with Achondroplasia being considered for subsequent enrollment in future     studies sponsored by BioMarin. No study drug is administered.   "
128502|NCT01603082|"     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS     patients undergoing an Ad Hoc PCI   "
128503|NCT01603069|"     This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a     blinded and randomized assignment. The main objective is to see if safety and tolerability of     the drug is acceptable.   "
128504|NCT01603056|"     Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix     compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or     without asthma.      Sublingual immunotherapy has been used during several years and has been shown to provide     benefits compare to traditional subcutaneous treatment. This study will investigate if     improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a     consequence of being treated under specific immunotherapy.      This study aim also to contribute to the documentation of tolerability and safety profile of     Pangramin HDM Mix.   "
128505|NCT01603043|"     The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT)     injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size     change from baseline at Month 12.   "
128506|NCT01603030|"     This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate     the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual     administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post     Operative Inflammation and Infection in LASIK surgery.   "
128507|NCT01603017|"     Nuclear Magnetic Resonance Therapy (NMRT) is gaining as a novel mode of therapy in     osteoarthrosis. A prospective double blind randomised study of 100 patients was conducted to     investigate efficacy of NMRT in the treatment of mild to moderate osteoarthrosis (OA) of the     knee joint.      The null hypothesis was that there is no benefit of NMRT over placebo in mild to moderate     oteoarthosis of the knee.   "
128508|NCT01603004|"     Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic     neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to     treat pancreatic NETs. Traditional chemotherapy is also known as cytotoxic therapy and     works by killing cells that are actively dividing. There have been no studies to compare the     different types of treatment. Since the patient is eligible for treatment with either     sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may     help future patients benefit from these therapies.   "
128509|NCT01602991|"     This study aims to determine that this new technology, nasopharyngoendoscopy, is just as     effective in diagnosing problems as the current gold standard.   "
128510|NCT01602978|"     The purpose of this study is to investigate whether a validated sensor that is able to     measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth     Variability Index (PVI)] are in your blood during surgery can help your doctors manage how     much fluid and possibly blood you need to get during your surgery. The hope of the study is     that the device may provide an early indication you are having bleeding and this may mean you     need to be treated with a transfusion. Our current method of checking this is by getting a     blood sample for analysis. The investigators hope is that this device may be able to alert     the clinician of the need for blood or fluids without a blood draw being needed.   "
128511|NCT01602965|"     The purpose of this study is to evaluate the most effectiveness between a personalized     nutritional program with a counseling monthly phone call Versus personalized nutritional     program with self help Informative Booklet in a group of obesity or overweight patients     without counseling phone call.   "
128512|NCT01602952|"     A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic     myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase     inhibitors (Imatinib and/ or Dasatinib, Nilotinib) In this study, The efficacy and safety of     CML patients who are resistant or intolerable to imatinib in the Chronic and Accelerated     phases.      Phase 1      1. To investigate the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicity (DLT) of     oral Radotinib HCl bid (twice daily) in the Philadelphia chromosome-positive CML subjects who     are resistant, suboptimal responsive, or intolerant to imatinib OR resistant or intolerant to     at least one second-generation targeted anticancer agent while being resistant, suboptimal     responsive, or intolerant to imatinib simultaneously.      Phase 2        1. To investigate safety of oral Radotinib HCl in CML patients who are resistant or          intolerable to imatinib in the chronic and accelerated phases.        2. To evaluate hematologic and cytogenetic efficacy of oral Radotinib HCl in CML patients          who are resistant or intolerable to imatinib in the chronic and accelerated phases.   "
128513|NCT01602939|"     The aim of this study is to evaluate the efficacy in terms of clinical and biological     response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with     advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.   "
128524|NCT01602796|"     In this multicenter cluster randomized controlled trial stratified by school baseline     prevalence of smoking will be randomly allocated to the control or intervention group.     Control schools will receive normal smoking education and intrvention schools will receive a     four year class-based curriculum intervention (22 Classroom lessons), reinforcement of     smoke-free school policy, smoking cessation in parents, pupils, and teachers and information     and annual meeting with parents.      Study participants will be children aged 12 to 15 years old ; they will be followed to 2     years after high school. External evaluator and analyst will be blinded to school allocation.      The aim of this study is to analyze the effectiveness of a complex intervention to reduce the     prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old)     .   "
128514|NCT01602926|"     Hallux valgus is a common deformity of the big toe, defined as medial deviation of the first     metatarsal bone along with lateral deviation of the first toe. Surgery has been shown to be     beneficial when compared to orthotics or no treatment. While generally effective, surgery is     associated with significant post-operative pain and disability, with several weeks of limited     mobility. Minimally invasive techniques have the potential to lead to increased patient     satisfaction while still achieving adequate correction of the deformity.      This trial is a non-inferiority treatment study, with open-label, randomized, prospective,     controlled, parallel experimental design, to compare the clinical and radiographic outcomes     of a minimally invasive surgery versus a conventional surgery for hallux valgus. This trial     examines two different surgical interventions. No drug or device is being evaluated in this     trial.      60 to 100 patients, over the age of 18 years, undergoing surgical correction of mild to     moderate hallux valgus will be enrolled in the trial. The patients will be randomized to two     groups, one treated with a conventional distal osteotomy surgery, the other treated with a     minimally invasive surgery. Randomization will occur immediately prior to surgery via a     multitude of opaque envelopes containing a coded group assignment. Due to the differences in     the techniques, neither the investigator and the subject can be effectively blinded to the     group assignment. Data collection for the outcomes measures will occur preop, and then post     of at 2 weeks, 12 weeks, and at 1,2, and 3 years.      The primary outcomes measure is the Manchester-Oxford Foot Questionnaire Score (MOXFQ).     Manchester-Oxford Foot Questionnaire' (MOXFQ), a 16 item patient-reported questionnaire     consisting of three domains/scales: 'Walking/standing' (seven items), 'Pain' (five items) and     'Social interaction' (four items). The MOXFQ is a validated disease-specific outcomes scale     for foot and ankle surgery which has been shown to be responsive and reliable.      Secondary outcome measures are preoperative to postoperative change in hallux valgus angle     (HVA). Radiographic outcomes parameters will be measured using weight-bearing radiographs to     analyze preoperative and postoperative hallux valgus angle, and the correction or     normalization thereof. (Degrees of correction = 2 week preoperative HVA - 12 week     postoperative HVA.)   "
128515|NCT01602913|"     Type 2 Diabetes (T2DM) is a life-long, chronic condition affecting an individuals' ability to     regulate glucose levels in the blood. Diabetes can cause many severe complications if not     treated properly. Hyperglycemia is a regular effect of uncontrolled diabetes and can lead to     complications such as cardiovascular disease, chronic renal failure, diabetic retinopathy and     inability to maintain a healthy body weight.      Cardiovascular Disease (CVD) is now the leading cause of death worldwide, affecting millions     of people in both developed and non-developed countries. The buildup of cholesterol in the     bloodstream may cause the excess to be deposited in the coronary arteries of the heart and     the carotid arteries of the brain. The cholesterol deposits are a factor of the plaques that     cause blockage of the arteries which can in turn lead to heart disease and stroke. By     lowering the blood levels of cholesterol, risks of heart disease, strokes and heart attacks     are reduced. Medications such as HMG-CoA reductase inhibitors and fibrates are useful in the     prevention of CVD.      Pravastatin is a member of the drug class of statins, also known as HMG-CoA reductase     inhibitors, and is shown as an adjunctive therapy to diet. It is known to reduce the amount     of cholesterol and other fatty substances in the blood. In addition, pravastatin is indicated     to reduce the risk of myocardial infarction, revascularization and cardiovascular mortality     in hypercholesterolemic patients who do not have clinically apparent coronary heart disease.     The recommended starting dose for adults is 40 mg once daily. For patients who do not reach     the LDL-C goal with 40 mg, it is recommended to use an 80 mg dose. For persons with     significant renal impairment the recommended dose is 10 mg. Children aged 8-13 years have a     recommended starting dose of 20 mg daily. Adolescents aged 14 to 18 years have a recommended     starting dose of 40 mg daily.      Depression is known as the most common mental disorder and most prevalent type of mood     disorder today. It can be seen as a state of mood, a symptom, a syndrome or as a clinical     diagnosis. Depression is a common disorder, affecting about 121 million people worldwide.     Depression is more likely to co-occur with medical illnesses such as stroke, heart disease,     cancer and diabetes. Up to one-quarter of people with diabetes are estimated to experience     depression which is two times more than those who do not suffer from diabetes. Studies have     shown that major depression mainly occurs in 2¬4 percent of people in the community, in 5-10     percent of primary care patients and 10-14 percent of medical inpatients. Also, recent     studies have estimated that the symptoms continue over a 6 month to one year period in     patients with major depression. The severity of the symptoms and the incidence of medical     illness are expected to predict the persistence of depression. Depression can be treated     effectively by a variety of antidepressants and/or psychotherapies. If treated appropriately,     over 80 percent of people who suffer from depression can be helped.      Paroxetine is an orally administered selective serotonin reuptake inhibitor (SSRI)     antidepressant. It was the first antidepressant that was formally approved in the United     States for the treatment of panic attacks, major depression, post¬traumatic stress disorder,     social anxiety, generalized anxiety disorder, panic disorder and obsessive-compulsive     disorder. Paroxetine has a well-established safety profile and it shares the common side     effects and contraindications of other SSRI's which include nausea and somnolence and is     associated with weight gain.      This study proposes to conduct a retrospective cohort study to assess the risk of new onset     diabetes among patients undergoing treatment with Pravastatin or other statins, and     Paroxetine or other SSRI's. This study will compare the risk of co administration of two drug     classes versus the use of each agent alone. In addition, the risk among patients prescribed     Paroxetine and fibrates in combination, relative to the use of Paroxetine singly, will be     examined to determine whether any interaction found between Paroxetine and statins extends to     other drugs indicated for hypercholesterolemia.      The first primary objective of the study is to estimate the incidence of Type 2 Diabetes     (T2DM) among patients newly exposed to pravastatin in combination with paroxetine, or other     SSRIs, compared to those newly exposed to pravastatin alone. The second primary objective is     to estimate the incidence of Type 2 Diabetes (T2DM) among patients newly exposed to     paroxetine in combination with pravastatin, other statins, or fibrates, compared to those     newly exposed to paroxetine alone.   "
128516|NCT01602900|"     This study will investigate if a new experimental drug to treat Huntington's Disease gets     into the brain. If it does get into the brain the study will explore the relationship between     the amount of drug in the brain and the amount of drug in the blood. The study will involve     healthy male volunteers.   "
128517|NCT01602887|"     This is a BA study comparing the bioavailability of two new capsule formulations and one     solution formulation to the isethionate capsule used in phase 1 and 2 trials in healthy     volunteers.   "
128518|NCT01602874|"     The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone     regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal     infections (cIAI) and community acquired pneumonia (CAP).   "
128519|NCT01602861|"     The purpose of this study is to assess whether the diuretic drug spironolactone can prevent     chronic damage to transplanted kidneys caused by the medication that prevents rejection.      Spironolactone prevents the effects of the hormone aldosterone. Aldosterone is suspected of     being involved in the processes leading to chronic rejection of transplanted kidneys. Hence,     by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function     in transplant patients.   "
128520|NCT01602848|"     Medicaid-insured patients with frequent hospitalizations account for a disproportionate share     of visits and costs, and have caught the attention of policy makers, creating an impetus for     hospitals and health care providers to better understand and control associated expenditures.     Many such patients have specific unmet health and social needs. Based on our extensive pilot     work with this population, the New York State Department of Health recently awarded the New     York City Health and Hospitals Corporation one of seven statewide contracts to implement a     Chronic Illness Demonstration Project, aimed at improving care and reducing healthcare     expenditures for high cost Medicaid patients. Within this framework, the investigators     propose a group-randomized trial design to test whether specific outcomes related to health,     functional status, and quality of life resulting from a patient-centered, intensive care     coordination and management intervention correlate with improved linkage to primary care     while reducing hospitalizations and emergency department visits. The investigators will then     relate these benefits to program costs using standard cost-effectiveness analysis techniques.     Given that there are few examples of successful interventions for this population and     currently unparalleled Medicaid spending, there is an urgent need to demonstrate that     interventions to improve care coordination and optimize patients' use of the health and     social care system result in more efficient and less costly care.   "
128521|NCT01602835|"     This is a prospective cross-sectional, observational, single-center study of Alport patients,     in which a single, first morning voided urine collection will be acquired and used to     validate assays of urine biomarkers that reflect changes in glomerular protein filtration     barrier function.      The purpose of this study is to identify biomarkers indicative of changes in glomerular     filtration function that occur during the course of proteinuric renal diseases such as Alport     nephropathy.   "
128522|NCT01602822|"     This study will evaluate how safe and tolerable a combination of taking three-drugs will be     for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in     HIV uninfected adults.   "
128523|NCT01602809|"     Background:      - Small blood vessels (microvessels) in many different organs are affected by diseases such     as diabetes and atherosclerosis. These microvessels may also be abnormal in people who have     sickle cell disease. Stiffness of the red blood cells leads to problems in the microvessels     of the heart and kidneys. However, these problems may not be detected until these organs are     severely affected. Researchers want to study problems with microvessels in people with and     without sickle cell disease.      Objectives:      - To study how microvessels in the heart and other organs are affected by sickle cell     disease.      Eligibility:        -  Individuals at least 18 years of age who have sickle cell disease.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  All participants will have about 3 to 4 hours of testing for the study. Participants          with sickle cell disease who are having a pain crisis at the time they enter the study          may be asked to have the testing again when the crisis is over. The repeat testing will          occur at least 4 weeks after the pain crisis ends.        -  All participants will have the following tests:        -  Blood draws to check kidney and liver function, and other blood tests        -  Measure of blood flow in the brachial (upper arm) artery        -  Heart ultrasound        -  Ultrasound scans of arm muscles to study blood flow        -  Ultrasound scans after taking vasodilators to increase blood flow        -  Healthy volunteers will also have a magnetic resonance imaging scan. It will show blood          flow in the heart. This scan will involve another dose of a vasodilator.   "
128536|NCT01602640|"     Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and     extubation, as compared to the combination of fentanyl and midazolam in critically-ill     patients.   "
128525|NCT01602783|"     This research is being conducted to test an imaging technique that may be able to detect     small amounts of prostate cancer that can not be detected by standard imaging.      Many patients who are diagnosed with prostate cancer undergo surgery to remove the prostate.     After this surgery, some patients have a PSA blood test that reveals a low but detectable     level of PSA. This PSA may be produced by cancer cells in one of two locations: (1) near the     area where the prostate used to be, or (2) elsewhere in the body. If the cancer is only in     the area where the prostate used to be, it can be successfully treated with radiation to that     area. If the cancer is elsewhere, radiation is not helpful. Currently, there is no available     scan that can detect cancer when the PSA is still so low.      The test used in this study is called [11C] acetate PET screening. [11C] acetate is a     radioactive tracer that is given by vein to patients before PET scanning. The PET scanner     then detects radioactivity from the tracer that is attached to cells within your body and     uses this information to create images (pictures) on a computer screen.      [11C] acetate PET scanning has been shown in early studies to detect smaller amounts of     prostate cancer that can be detected by standard imaging tests such as CT scan and bone scan.     If it is successful at detecting very small amounts of prostate cancer, [11C] acetate PET     scanning will help doctors identify patients who will benefit from radiation therapy after     their prostate has been surgically removed. It will also help them identify patients who have     small amounts of prostate cancer in other parts of the body and will not benefit from     radiation to the prostate area.      This type of PET scan is investigational. Investigational means that the scan is still     being studied and that research doctors are trying to find out more about it. It also means     that the FDA has not approved this type of PET scan for your type of cancer. The information     collected by this scan will determine whether this type of scanning is helpful but it will     not be used to make decisions about your medical care.   "
128526|NCT01602770|"     Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being     the first oral contraceptive delivering estradiol. It has been recently approved in Mexico.     To evaluate the clinical profile of this drug combination under routine medical condition, a     post-authorization safety study required by Mexican Health Authorities will be conducted in     Mexican women.      The study will be performed as a descriptive study, no hypothesis will be tested. The cohort     consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical     conditions. Subjects should provide all necessary information on health-related events or     changes in health status during Qlaira use.      Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or     not related to Qlaira during at least 2 years of observation.      In order to comply with the criteria of a non-interventional study, women only will be     informed about the study, asked to participate and included in the study after Qlaira has     been prescribed.      Study patients follow-up will be done in accordance with common clinical practice as     described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM     005-SSA2-1993).   "
128527|NCT01602757|"     This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and     12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.   "
128528|NCT01602744|"     The purpose of this study is to determine if the use of STOPP/START criteria (STOPP-screening     tool of older persons potentially inappropriate prescriptions START-screening tool to alert     doctors to right treatment)for medication intervention in elderly population living in a     geriatric hospital will lower the number of falls,hospitalization,will improve functioning,     quality of life and reduce financial costs.   "
128529|NCT01602731|"     Trialing an automated medication dispensing device (AMDD) to improve medication adherence in     patients with heart failure.   "
128530|NCT01602718|"     This study will compare physical activity levels and physical functioning in patients treated     with home dialysis vs. those treated with in-center dialysis. The investigators will first     compare prevalent patients, and will also compare the two groups longitudinally in incident     patients over the first 18 months of beginning the dialysis treatments. Patients will be     tested for physical functioning using standard performance-based testing such as gait speed,     chair stand, balance test, as well as self-reported limitations in activities of daily     living. The investigators will monitor physical activity using step counters and activity     questionnaires. Blood samples will be drawn at each testing time to measure inflammatory     markers. A pilot study of home dialysis patients will be done to determine the effects of an     independent home-based exercise program on physical functioning and inflammatory markers. For     this pilot study, 30 patients will be randomized into exercise intervention and usual care     with testing at baseline and again after 3 months of the intervention.   "
128531|NCT01602705|"     We hypothesise that feedback and feedback + psychology informed intervention delivered to     primary care medical practices will reduce high-risk prescribing to patients compared to a     simple educational intervention alone. The specific objectives are :        1. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified          primary outcome of a composite measure of high-risk antipsychotic, non-steroidal          anti-inflammatory drug, and antiplatelet drug prescribing        2. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified          secondary outcomes of the six individual measures constituting the composite        3. To assess the cost-effectiveness of the intervention   "
128532|NCT01602692|"     The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent     solution containing both dilute lidocaine and epinephrine will lead to better control of     postoperative pain, nausea, vomiting, shorter time through postoperative phases of care,     quicker discharge from the hospital and lower numbers of hospital readmissions than the use     of tumescent solution containing only dilute epinephrine.   "
128533|NCT01602679|"     The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in     women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency     within 10 hours. The investigators propose to assess this further with a randomized,     cross-over, placebo-controlled study. Regularly cycling women without hyperandrogenism will     be admitted to the Clinical Research Unit on cycle day 5-9 (mid-follicular phase) for a 10     hour frequent sampling study to observe LH, FSH, estradiol, progesterone, and testosterone.     Either oral micronized progesterone suspension or placebo will be administered at 0900 h.     During a subsequent menstrual cycle, subjects will undergo another study identical to the     first except that oral progesterone will be exchanged for placebo or vice versa in accordance     with a crossover design.   "
128534|NCT01602666|"     Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy     with radiation therapy may kill more tumor cells. This phase II trial studies how well     chemotherapy and radiation therapy work in treating younger patients with newly diagnosed     central nervous system germ cell tumors.   "
128535|NCT01602653|"     The purpose of this study is to compare two different ranges of energy flux density with     Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.   "
128539|NCT01602601|"     Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients     who are currently being treated with idursulfase, an enzyme replacement therapy, and in at     least a single patient who is naïve to treatment, if possible to recruit. All patients     enrolled into the study will have a single blood draw for the analysis of antibodies induced     by this enzyme replacement therapy (idursulfase). Patient samples with positive responses to     antibodies induced by idursulfase will be used to further evaluate whether the antibodies     induced by idursulfase bind to GSK2788723 molecules in vitro and if these antibodies     neutralize the bioactivity of GSK2788723 in vitro. Each subject will have a screening visit,     which may occur at their regularly scheduled out-patient visit. If the patient consents to     participate in the study, a blood sample (total volume of approximately 3mL) for     immunogenicity analysis will be drawn before their current treatment infusion   "
128540|NCT01602588|"     There is emerging evidence that hydroxychloroquine (HCQ), a drug used commonly in the     prevention/ treatment of malaria, rheumatoid arthritis and lupus erythematosus, may improve     survival outcome in a variety of cancers including HGG, with few side effects.      In this trial the investigators wish to investigate whether treatment with radiotherapy and     hydroxychloroquine is more effective than treatment with radiotherapy alone.   "
128541|NCT01602575|"     The purpose of this study is to use functional magnetic resonance imaging (fMRI) to evaluate     brain resting state networks, responses to abdominal stimuli and the effect of MBSR Training     on these measures. The goal of this study is to identify biomarkers of IBS and assess the     responsiveness these biomarkers after MBSR Training. A biomarker, or biological marker, is in     general a substance or measure used as an indicator of a biological state. It is a     characteristic that is measured and evaluated as an indicator of normal biological processes,     disease processes, or responses to a therapeutic intervention, in this case MBSR.   "
128542|NCT01602562|"     The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety     of valaciclovir (VACV) in the adult and pediatric HSCT patients.   "
128543|NCT01602549|"     Gastric emptying is the end-result of a complex and carefully regulated series of events     which follow the ingestion of a meal, each of which is dependent on the other and subject to     neurohormonal control. Motilin is an endogenous peptide, produced mainly in the duodenum,     whose physiological action is mediated by motilin receptors located on enteric neurons,     peripheral terminals of the vagus, and on the smooth muscle of the gut. Motilin and     non-peptide agonists at motilin receptors increases the gastric emptying rate and therefore     provide a potential approach to the treatment of a range of clinical conditions in which     delayed gastric emptying is thought to be part of the physiopathology and may be contributory     to symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder     characterized by degeneration of nigrostriatal dopaminergic neurones. It affects 1.5% of the     global population over 65 years of age. Cardinal symptoms comprise bradykinesia, rigidity,     resting tremors and postural instability. Gastrointestinal dysfunction, including     gastroparesis, is a frequent feature of PD affecting approximately 90% of patients, and is     caused by autonomic dysfunction as well as an adverse effect of antiparkinsonian drug     therapy. The therapeutic mainstay for PD treatment is the neutral amino acid     L-3,4-dihydroxyphenylalanine (L-DOPA), a dopamine prodrug, as it provides the most rapid and     effective symptomatic control of motor impairment in PD. The primary determinant of L-DOPA     bioavailability is gastric emptying (GE); delays in GE slow delivery of L-DOPA to its     proximal small intestinal absorption sites, increasing the extent of presystemic metabolism,     and leading to slowed and diminished absorption.   "
128544|NCT01602536|"     In Phase I (N=40), we developed a treatment protocol for smoking cessation and relapse     prevention that used virtual quit-smoking Twitter groups and Twitter-enabled interactive peer     messaging. We tested and refined this protocol using two quit-smoking Twitter groups. In     Phase II (N=160), we conducted a two-arm (test vs. control) randomized controlled trial of     the treatment protocol created in Phase I. In Phase III (N=80) we ran additional quit-smoking     Twitter groups and tested various interventions to increase engagement in the intervention,     e.g., peer leaders. This research provided crucial data about the viability and methodology     to be used in a larger randomized controlled trial that would directly measure smoking     behavior.   "
128545|NCT01602523|"     This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an     inhaled medication that contains 2 drugs. One is a medication that opens up the airways     (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort     is not an experimental medication. It is approved by the Food and Drug Administration for use     in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause     of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening     the airways and reducing lung inflammation. It is not known for sure if these effects     actually improve sleep and quality of life. It is hoped that this study will answer this     question.   "
128546|NCT01602510|"     This registration study in China is a multi-centre, double-blind, placebo-controlled clinical     trial to evaluate the efficacy and safety of lamotrigine in the prevention of     recurrence/relapse of mood episodes in subjects with bipolar I disorder. Subjects are bipolar     I disorder patients with recent/current manic, hypomanic, mixed or depressive episode. The     study will include an open-label phase and a randomized phase. During the open-label phase,     subjects will have lamotrigine monotherapy or combination therapy escalation. The target dose     of lamotrigine is 200 milligram (mg)/day monotherapy. The duration of treatment in the     open-label phase will last 6-16 weeks, until subjects reach a stable dose of lamotrigine.     Beginning at week 7 of the open-label phase, subjects who have reached a stable dose of     lamotrigine and met response criteria, defined as maintaining a Clinical Global Impression of     Severity (CGI-S) score <= 3 for at least 4 continuous weeks and maintaining lamotrigine 200     mg/day monotherapy for at least 1 week, will be eligible to enroll in the double-blind phase     of the study. Subjects who have not met response criteria after 16 weeks of participation in     the open-label phase will be withdrawn from the study. Subjects will have lamotrigine 200     mg/day monotherapy for at least 1 week prior to randomization. Subjects who have met     randomization requirements will be randomized 1:1 to lamotrigine 200 mg/day or placebo for 36     weeks double-blind treatment. After randomization, subjects will be assessed at weekly     intervals for the first month, biweekly intervals for the second month, and then at monthly     intervals for up to 36 weeks of double-blind treatment. The primary endpoint will be TIME,     defined as the time to intervention (addition of pharmacotherapy or electroconvulsive therapy     [ECT]) for any mood episode (relapse or recurrence of a depressive, manic, hypomanic or mixed     episode) after randomization. The secondary endpoints will include time to intervention for     manic, hypomanic or mixed episode (TIMan) and time to intervention for depressive episode     (TIDep).The scores on the Hamilton Depression (HAMD), Young Mania Rating Scale (YMRS), CGI-I,     CGI-S and Global Assessment Scale (GAS) will be used as indicators for both intensity and     duration of mood symptoms during this phase. Subjects who withdraw early from the study prior     to week 36 or reach TIME will have a follow-up visit 14 days after the last dose of     investigational drug.   "
128547|NCT01602497|"     This study is going to evaluate the effects of repetitive transcranial magnetic stimulation     (rTMS) on Borderline Personality Disorder patients symptoms.   "
128549|NCT01602471|"     This trial will be the first trial for the Investigation Product (IP), [F-18]RGD-K5 for     carotid plaque imaging and will be conducted as a Phase II trial since this compound has     already been tested in humans for phase I and phase II imaging. All study results will be     evaluated and analyzed in order to consider the design for future clinical trials.   "
128550|NCT01602458|"     The study's objective is to compare the global scar outcomes in those treated with silicone     only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of     hypertrophic scarring in children with skin grafts after traumatic skin injury.   "
128551|NCT01602445|"     The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases     their quality of life, delays their treatment and may cause death. The best way to avoid new     clots is by giving blood thinners before clots are formed, but even some patients who are     taking blood thinners may form blood clots. A major problem is that it is difficult to know     which patients form clots while they are receiving blood thinners, a situation called     treatment failure. Several studies have shown that by doing blood tests that measure the     formation of clots, the investigators could know if the patient is responding to the blood     thinners. If this is proven, the investigators will be able to apply these tests to all     patients.   "
128552|NCT01602432|"     Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli)     which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays     cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients     without blood clots. Blood thinners may prevent clots but major bleeding is also a problem,     so preventive therapies are not used routinely. Identifying patients at highest risk for     clots is critical. A tool exists but it has not been used outside of research. We propose to     study how to apply this tool in clinical practice and test if it works.   "
128553|NCT01602419|"     This is an observational study, hence there is no study hypothesis   "
128554|NCT01602406|"     This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum     Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination     with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)     overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of     a dose escalation part and a dose expansion part. LJM716 will be administered intravenously     once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks     is introduced. Patients will continue on their trastuzumab dosing, administered intravenously     once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be     treated in successive cohorts. The dose escalation will continue until the MTD/RDE is     declared. The RDE dose selected will either be the MTD or a dose below the MTD based on     safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE     declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in     the dose expansion part and treated at the MTD/RDE to further assess the safety,     tolerability, and anti-tumor activity of the combination.   "
128555|NCT01602393|"     The purpose of the study is to evaluate the safety and tolerability of ascending oral doses     of CHF 5074 after prolonged administration to patients with mild cognitive impairment.   "
128556|NCT01602380|"     The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or     Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or     metastatic breast cancer who have not had prior hormonal treatment.   "
128557|NCT01602367|"     The purpose of this study is to determine whether BMS-823778 is safe and effective in the     treatment of hypertension in overweight and obese patients.   "
128558|NCT01602354|"     The purpose of this observational study is to determine whether endotoxin levels and/or their     trends can be considered predictive of morbility or mortality in septic shock caused by     gram-negative bacteria, searching also for a possible correlation with Simplified Acute     Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells     (WBC) and Platelets (PLT).   "
128559|NCT01602341|"     The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment,     2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of     adolescents with atopic dermatitis (AD)   "
128560|NCT01602328|"     Subjects entering the study will have undergone cardiac surgery. Those who experience kidney     injury within 48 hours of their surgery will be enrolled into the study. Once enrolled,     subjects will receive a single administration of AC607 or placebo. Kidney recovery will be     evaluated over the subsequent 30 days and death or the need for dialysis will be evaluated     within 90 days of dosing. After 90 days (evaluation period), subjects will enter a 3-year     extension phase of the study to monitor safety and long-term outcomes (follow-up period).   "
128561|NCT01602315|"     This is a multi-center, open-label, Phase Ib dose escalation / Phase II study in recurrent or     metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be     resistant, ineligible or intolerant to platinum-based chemotherapy. The first aim of the     Phase Ib is to determine the Maximum Tolerated Dose(s) (MTD(s)) and/or the Recommended Phase     II Dose(s) (RP2D(s)) for BYL719 in combination with cetuximab This part will include two     different arms using two different administration methods of BYL719 tablets together with     cetuximab as recommended by the label: Arm A - whole tablets will be administered to patients     able to swallow the tablets vs. Arm B - a drinkable suspension prepared from crushed tablets     will be administered to patients with swallowing dysfunction. The second aim of the Phase Ib     is to compare the pharmacokinetics (PK) of the new dispersible tablet formulation of BYL719     in combination with cetuximab. A third arm will be opened: Arm C, which will use a suspension     from a dispersible tablet administered via gastric feeding tube (G tube). The safety,     tolerability, PK, PD, and efficacy will be investigated separately in the Phase Ib arms. The     MTD/RP2D will only be investigated independently for Arm A and B. The one of Arm B will be     compared to that of Arm A. If the MTD/RP2D is the same, then both administration methods of     BYL719 may be used in Phase II. If the MTD/RP2D is different, then only the administration of     BYL719 whole tablets will be allowed in the Phase II. Arm C is an independent relative     bioavailability study of the new dispersible tablet formulation of BYL719, which will begin     at the starting dose/RP2D identified with a safety cohort followed by an expansion cohort.     There will be no dose escalation or de-escalation in this Arm. If either the safety or     pharmacokinetic profile of the RP2D of 300 mg QD in Arm C is not comparable with Arm A, then     enrollment in Arm C will cease and the dispersible tablet will not be implemented in Phase     II.      The Phase Ib dose escalation part is expected to enroll approximately 12 patients for Arm A     and B and will be guided by a Bayesian logistic regression model (BLRM). The available     safety, tolerability, PK, PD and efficacy data, as well as the recommendations from the BLRM,     are used to determine the dose combination for the next cohort(s). The Phase II part of the     study will commence upon MTD/RP2D declaration of Arm A in Phase Ib, regardless of the     progress of Arm B and C.      The Phase II part will assess the clinical efficacy of BYL719 in combination with cetuximab     in two patient populations: patients will be assigned to one of two schemes of enrollment     based on prior therapy with cetuximab.      Patients considered cetuximab naïve per protocol will be assigned to Scheme 1. The primary     purpose of this scheme is to assess the anti-tumor activity of BYL719 in combination with     cetuximab (Arm 1) vs. cetuximab as single-agent (Arm 2) in RM HNSCC patients' naïve to     cetuximab. Patients in scheme 1 will be randomized in a 2:1 ratio via IRT in two Phase II     arms: BYL719 in combination with cetuximab (Arm 1) vs. cetuximab as single-agent (Arm 2).     Patients randomized to Arm 2 (cetuximab monotherapy) will have the opportunity to cross-over     to combination treatment with BYL719 + cetuximab after experiencing disease progression. Arm     1 will consist of approximately 66 patients and Arm 2 of approximately 33 patients.      Patients having received prior cetuximab per protocol will be assigned to Scheme 2. The     primary purpose of this scheme is to assess the anti-tumor activity of BYL719 in combination     with cetuximab in RM HNSCC cetuximab resistant patients (Arm 3). Patients in this scheme will     not be randomized. 40 patients will be enrolled. Phase II will further characterize the     safety and PK of the drug combination.      Patients will be treated until progression of disease (except for phase II Arm 2),     unacceptable toxicity, or withdrawal of informed consent, whichever occurs first. Patients     enrolled in Arm 2 experiencing disease progression will have the opportunity to crossover to     the combination treatment (Arm 2B) and they will continue until they experience unacceptable     toxicity that precludes any further treatment, until disease progression, and/or until     treatment is discontinued at the discretion of the Investigator or by patient refusal. In the     follow-up period all patients must complete the safety follow-up assessments 30 days after     the last dose of the study treatment. Patients who have not progressed at the time of     discontinuation of study treatment should be radiologically followed for disease status until     disease progression, initiation of subsequent anticancer therapies, or death, whichever     occurs first. In addition, all patients enrolled in Phase II will be followed for survival.   "
128562|NCT01602302|"     biological DMARDs may be stopped in Rheumatoid Arthritis (RA) patients treated with a     combination of synthetic DMARD plus bDMARDs which are in persistent clinical remission. The     research question of this study is, whether musculoskeletal sonography is a useful biomarker     predicting a disease flare after cessation of bDMARD therapy.   "
128563|NCT01602289|"     The purpose of this study is to assess the safety and tolerability of LY2875358 in Japanese     participants with cancer that is advanced and/or may have spread to another part of the body.   "
128564|NCT01602276|"     This research is being done to determine whether transcranial direct current stimulation     (tDCS) can improve certain abilities related to cognition, emotion and/or physical     functioning in individuals with subcortical brain damage.   "
128565|NCT01602263|"     This research is being done to determine whether transcranial direct current stimulation     (tDCS) can improve certain mental abilities. In this research, battery powered device is used     to deliver very weak electrical current to the surface of the scalp while participants     complete cognitive tasks. Our aim is to find out whether tDCS will improve task performance     in both healthy adults and those with neurological impairment.   "
128588|NCT01601964|"     The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and     change in patient with ectopic pregnancy who needs to surgical treatment.      Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be     included in the study. This is an observational study.The plasma Vascular Endothelial Growth     Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.   "
128566|NCT01602250|"     The systemic toxicity of local anaesthetics may be treated using lipid emulsions (lipid     rescue). However, there is no evidence-based proof of the efficacy of the treatment. The aim     of the intended protocol is to study the effect of the emulsion Intralipid® on the toxicity     prodromes in volunteers receiving either levobupivacaine or ropivacaine. After a     sensitization session with lidocaine, subjects will receive in a double blind, crossover     manner an i.v. infusion of levobupivacaine or ropivacaine followed by a rapid infusion of     Intralipid®. The primary outcome will be the time of appearance of early neurologic signs of     toxicity. In addition, the EEG and ECG will be monitored and blood sampling will be performed     in order to evaluate the changes in pharmacokinetics induced by the emulsion.   "
128567|NCT01602237|"     The study is a follow-up of investigations done in the years 1999-2002 in bakery employees.     The main purposes are to look at the associations between flour dust exposure and respiratory     disease, and to find out the best ways to reduce the flour dust levels in the working     environment.   "
128568|NCT01602224|"     The purpose of this study is to evaluate an investigational drug called tabalumab in     participants with Multiple Myeloma (MM) who have tried at least one other therapy in the     past. Tabalumab will be given in combination with standard doses of two other drugs that are     often used to treat MM. Study doctors will collect information about the effectiveness and     side effects of this therapy.   "
128569|NCT01602211|"     This randomized clinical trial studies an internet and social-media program for improving     quality of life in long-term survivors who underwent stem cell transplant. In this study,     researchers want to compare a survivorship internet program to the standard treatment of     currently available internet sites for transplant survivors to learn which works better for     people who have received bone marrow or blood stem cell transplants. A survivorship-focused     internet program may improve mood, stress, and preventive health care, and provide useful     health resources for transplant survivors. It is not yet known whether currently available     internet sites are more effective than a survivorship-focused internet program in improving     quality of life in cancer survivors.   "
128570|NCT01602198|"     The goal of this project is to determine if task-activated fMRI is sensitive to the central     cholinergic deficit associated with Mild Cognitive Impairment.   "
128571|NCT01602185|"     The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to     ketamine maintains or induces a decrease of pain intensity.      In clinical, after ketamine cure, clinicians have often difficulties to treat patients in     order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was     not effective, which occurs in one quarter of patients. It will be very useful for monitoring     of painful patients evaluate if memantine or dextromethorphan could be an effective     therapeutic alternative in neuropathic pain treatment.   "
128572|NCT01602172|"     Veterans drink, binge drink, and drive under the influence of alcohol at higher rates than     non-Veterans do. Addressing alcohol misuse, the range of alcohol consumption from risky     drinking to alcohol abuse and alcoholism, is a national priority for the VA. It is     recommended that people keep their alcohol consumption below limits established by the     National Institutes of Health (NIH). A type of 10-15 minute counseling known as brief     intervention (BI) has been shown to help risky drinkers cut back to the NIH-recommended     limits. This study will examine the impact of a nurse-delivered alcohol BI on hospitalized     Veterans' weekly number of drinks, monthly number of binge drinking episodes, readiness to     change drinking behavior, and alcohol-related problems. This preventative approach for     reducing alcohol consumption is intended to help Veterans avoid many of the physical and     psychosocial consequences of alcohol misuse.   "
128573|NCT01602159|"     This is a prospective randomized controlled trial to compare clinical improvement, cost     effectiveness and patency rates between new and improved Nitinol stents and open bypass     surgery in the superficial femoral artery disease.      Secondary outcomes also include comparing quality of life, re-intervention rate, mortality,     morbidity and time to return to work or regular activities.      Patients with superficial femoral artery lesions will be considered. Patients with TASC II A     lesions will not be randomized but treated with PTA/stenting as standard of care. Patients     with TASC II B and C lesions will be prospectively randomized into either receiving open     bypass or stenting.      Patients with TASC D lesions will be treated with open bypass surgery after angiography.      The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on     all enrolled the patients.   "
128574|NCT01602146|"     Acute physiological consequences of ultramarathon running are still unknown, particularly in     women. Results from the investigators first studies conducted in 2009 have shown that a large     part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue.     The investigators have investigated the biological consequences and neuromuscular fatigue     only in male runners. Data from the literature suggest that amplitude and etiology of fatigue     after prolonged exercise might be gender-dependant.The main purpose of the present project is     thus to quantify supraspinal central fatigue and associated changes in cortical excitability     after an extreme exercise such as a mountain ultramarathon: the Ultra-Trail du Mont-blanc, by     using TMS.   "
128575|NCT01602133|"     Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous     catheter during a period of seven days.   "
128576|NCT01602120|"     This is a multicenter, open-label extension study of safety and tolerability of lampalizumab     administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who     have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week     treatment in Study GX29455 (NCT02288559).   "
128587|NCT01601977|"     COPD continues to be a cause of major morbidity for patients. Those patients who also have     respiratory failure and obstructive sleep apnoea are at higher risk of exacerbations and     death and have worse health related quality of life than similar COPD patients without     respiratory failure.      Treatment options in this group of patients have been limited and data to support the use of     machines to assist breathing (non-invasive ventilators) in stable patients are limited. A     major limitation of these devices has been patient acceptance and achieving sufficient     control of sleep breathing disturbance.      Currently devices are set at a fixed pressure to support the breathing throughout the night.     The new software within the trial device will aim to better match the support provided by the     machine to that needed by the patient. It is hoped that this may offer enhanced comfort as     well as superior control of respiratory failure.   "
128577|NCT01602107|"     Urinary incontinence (UI) affects up to 50% of adult populations and stress urinary     incontinence (SUI) is the most common form of UI, accounting for approximately 60% of     patients. Women are affected by SUI much more often than men. Urine leakage in women with SUI     occurs on exertion or during tasks that increase pressure on the bladder such as sneezing or     coughing. SUI has been shown to be a barrier to physical activity in women, and as such can     contribute to the development of diseases and disorders associated with inactivity.      SUI appears to have many contributing factors such as structural damage (eg. tears in the     pelvic organ supporting tissues), muscle weakness related to nerve injury or aging, or     thinning of the urethral wall and/or its surrounding muscular sphincters. Currently the most     common treatments for SUI are conservative therapy, which normally takes the form of exercise     therapy provided by specialized nurses or physical therapists, and surgery, which is aimed at     enhancing urethral support. Exercise therapy is effective, resulting in complete cure in 50%     of cases, and surgery is effective for approximately 80% of patients but carries risks such     as the development of urinary retention. It is currently not clear which treatment approach     is better for which women.      Through the proposed research, the investigators aim to determine how to predict which     patients will improve or be cured with exercise therapy such that surgery can be avoided.     Specifically the investigators will determine what is different between patients in whom     exercise therapy succeeds and in whom exercise therapy fails. The investigators will also     determine whether physiotherapist-supervised training of the pelvic floor muscles before     surgery improves surgical outcomes. The proposed research will enable us to better understand     the female continence system and how it responds to physiotherapeutic intervention. It will     help us to develop improved assessment procedures that can streamline patient management.   "
128578|NCT01602094|"     Prevalence of participants who have protective immunity to measles virus is less than ninety     percent.      Predictor of adequate measles antibody levels include the following :        -  History of measles infection        -  History of complete measles primary immunization( 2 doses with at least 1 month interval          after age of 9 months)        -  History of measles exposure      Predictor of inadequate measles antibody levels include the following :        -  Born outside Thailand        -  History of staying outside Thailand for long time in childhood        -  Living in the rural area for a long period in childhood        -  Fail to participate school system on time   "
128579|NCT01602081|"     The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of     fistula closure in patients with persistent trans-sphincteric anal fistula who receive the     Biodesign® Tissue graft as part of their LIFT procedure.   "
128580|NCT01602068|"     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with     dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery     System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation     of a posterior chamber intraocular lens.   "
128581|NCT01602055|"     The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets     (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference     product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd   "
128582|NCT01602042|"     The purpose of this study is to evaluate the utility of a portable motion sensor-based system     designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms     and expand care for ET patients.   "
128583|NCT01602029|"     Negative symptoms and cognitive deficits are two partially-related features of schizophrenia     which have a major negative impact on social function and objective quality of life. Standard     drug treatments have little impact on either and arguably no effect on primary negative     symptoms. Social dysfunction has major economic consequences in both the developed and     developing world. There is evidence that anti-inflammatory treatment may have beneficial     effects in patients with schizophrenia.   "
128584|NCT01602016|"     Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking     at the effects of Folinic Acid on language in Autism Spectrum Disorder and language     impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment     (there is no compensation for this visit). If language impairment is verified in the phase 1     screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12     weeks of folinic acid or an inactive placebo, in addition to several evaluations of your     child's abilities and a single blood test. Children that complete phase 2 will be eligible     for a 12 week open-label trial of folinic acid which is phase 3.   "
128585|NCT01602003|"     Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group     study The study was divided into three parts: part 1 was a screening period started with an     initial 2 weeks of exercise/diet program; part 2 was a double-blind treatment period during     which eligible patients were randomized to Sitagliptin 100 mg qd (once daily), LC15-0444 25     mg bid (twice daily), or LC15-0444 50 mg qd groups and received the assigned treatment for 24     weeks; part 3 was for those patients who completed part 1 & 2 and consented to receive     another 28 weeks of treatment with LC15-0444 50 mg qd.      Screening tests were performed on the patients who had given the written informed consent.     After 2-week exercise/diet program according to the generally recognized guideline, eligible     patients were assigned one of three treatment groups with 1:1:1 ratio. During the total of     24-week treatment period of part 2, each patient visited the study site at Week 6, 12, 18,     and 24. Completing double-blind treatment for 24 weeks, each patient was asked to provide     consent to participate in the part 3 of the study where all the patients were to receive     LC15-0444 50 mg once daily. During 28-week treatment period of the part 3, each patient     visited the study   "
128586|NCT01601990|"     Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group     study The study was divided into three parts: part 1 was started with an initial 2 weeks of     exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part     2 was a double-blind treatment period during which eligible patients were randomized to     LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3 was     for those patients who completed part 1 & 2 and consented to receive another 28 weeks of     treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given     the written informed consent. After 2-week exercise/diet program according to the generally     recognized guideline, patients took placebo for another 2 weeks while continuing     exercise/diet program. When the 2-week placebo run-in period was completed, eligible patients     were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the total of 24-     week treatment period of part 2 after randomization, each patient visited the investigational     site at Week 6, 12, 18, and 24. Completing treatment with placebo or LC15-0444 50mg for 24     weeks after randomization, each patient was asked to provide consent to participate in the     part 3 of the study where all the patients were to receive LC15-0444 50mg regardless of the     treatment received during the part 2 of the study. During 28-week treatment period of the     part 3, each patient visited the investigational site at Week 30, 38, 46, and 52. Total study     period from screening was 56 weeks per each patient.   "
128589|NCT01601951|"     The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the     treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells     that has been shown to have regenerative properties. This study is designed to evaluate the     short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.      Inclusion Criteria:        -  Subjects must be scheduled for an autologous bone marrow hip or knee injection        -  Subjects must have a diagnosis of hip or knee osteoarthritis        -  Subjects must be between the ages of 18 and 85        -  Subjects must be willing and able to sign Informed Consent        -  Subjects must be willing and able to return for scheduled follow-up evaluations      Exclusion Criteria:        -  Subjects who have had any type of visco-supplementation in the treated joint within the          last three months prior to enrollment        -  Subjects for whom baseline data is not available   "
128590|NCT01601938|"     This study will be performed to determine whether selenium replacement reduces 28-day     mortality of severe sepsis and septic shock patients, and to investigate whether selenium     replacement contributes differently to the mortality reduction of the patients according to     their initial serum selenium level.   "
128591|NCT01601925|"     Stellate ganglion block targets are C6 transverse process or C7 transverse process in     anterior paratracheal approach which is most popular method. Cricoid cartilage is known that     it is located at C6 level in supine neutral position of the neck. But stellate ganglion block     is performed in supine extended position of the neck. So cricoid cartilage will move up to     cephalad direction and pain doctors should find C6 or C7 transverse process at lower neck     area than cricoid cartilage.   "
128592|NCT01601912|"     The primary study aim is to unravel the nature of impaired pain inhibition during exercise in     patients with chronic Whiplash-Associated Disorders (WAD). This will be ascertained by     examining whether activation of serotonergic and/or noradrenergic descending pathways     improves pain inhibition during exercise in these patients. In addition, it is aimed at     examining whether activation of serotonergic and/or noradrenergic descending pathways     prevents post-exertional malaise following submaximal exercise in chronic WAD patients. A     secondary study aim comprises of examining the effect of an acute submaximal exercise with     and without activation of serotonergic or noradrenergic descending pathways on chronic WAD     patients' cognitive performance. Furthermore, the isolated effect of activated serotonergic     and noradrenergic descending pathways on chronic WAD patients' cognitive performance will be     studied.   "
128593|NCT01601899|"     Even with the benefits of HIV therapy, there is a possibility that HIV-infected individuals     develop metabolic complications once they initiate treatment, which may also ultimately put     them at a risk for impending heart disease in the next decades.      The main mechanism through which the main HIV drugs are thought to cause these metabolic     changes and organ toxicities is mitochondrial toxicity. Most of studies that have been done,     have taken place in the West, but few, if any, have been done in South Africa.      The purpose of this study is to prospectively identify early changes between the two     different drugs, Stavudine and Tenofovir, to assess their virological response, molecular,     biochemical and clinical picture, and the possible associated change in cardiovascular risk     factors, this, in the South African setting, and make recommendations to modify the current     National AIDS role out programme   "
128594|NCT01601886|"     This study was designed to analyze whether initiation of the NICHD Neonatal Research Network     SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery     room in non-participants and whether these changes were associated with changes in management     and outcomes.      The investigators hypothesized that the investigators would observe following the initiation     of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among     non-participants preterm infants at Parkland Memorial Hospital.   "
128595|NCT01601873|"     The purpose for this study is to evaluate the patency and outcomes of conventional and     heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.   "
128596|NCT01601860|"     Although there are studies that investigated the use of non-pharmacological pain relief and     correction of dystocia during labor, there are few randomized controlled trials, especially     related to combined protocols that use such resources. The use of combined protocols could     potentiate the effects of resource use alone, evidencing the need for more studies related to     the topic, as well as the effects of these methods on maternal and perinatal outcomes. In     order to verify the effect of these methods in various stages of labor, childbirth and     immediately becomes necessary to conduct a randomized controlled trial well-designed and     adequate sample size that can make the future systematic reviews that can definitely conclude     about the potential effectiveness of protocols that use combined resources to     non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a     protocol of non-pharmacological resources on pain of pregnant women in the active phase of     cervical dilatation and compared with controls.   "
128597|NCT01601847|"     The goal of this study is to identify a vitamin D supplementation strategy that best promotes     the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational     age). This is a high risk population that seems to have unique vitamin D needs, and     inappropriate supplementation may promote wheezing or allergy. The results of this study will     help form nutritional recommendations for the approximately 100,000 black infants born at     30-36 weeks gestational age in the U.S. every year.   "
128598|NCT01601834|"     The purpose of this study in healthy people is to evaluate safety, toleration and time course     of plasma concentration of single oral doses of PF-06273340. The effect of food on the     Pharmacokinetic of PF-06273340 may also be investigated.   "
128599|NCT01601821|"     To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) +     corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the     introduction of MMF in de novo renal allograft recipients.   "
128600|NCT01601808|"     ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib     chemotherapy with gemcitabine alone in patients with locally advanced or metastatic     pancreatic carcinoma.   "
128753|NCT01599819|"     The objectives of this study are to assess the tolerability and safety after single dose     treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to     determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE,     and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.   "
128601|NCT01601795|"     The use of volatile anesthetics in cardiac anesthesia is very common, because of their     cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In     line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics     are widely used to avoid a delayed recovery from cardiac surgery and anesthesia. Volatile     anesthetics are delivered from calibrated vaporizers in the anesthesia machine or the     cardiopulmonary bypass machine (during extracorporeal circulation).      Isoflurane and Sevoflurane are the most commonly used volatile anesthetics in patients     undergoing cardiopulmonary bypass (CPB). The vaporizer of the anesthetics is on the     cardiopulmonary bypass machine and the volatile agent is blended with air and oxygen. Until     now, the pharmacokinetics of halothane, enflurane, isoflurane and desflurane during CPB have     been described.      Sevoflurane might be of advantage because of additional myocardial protective effects during     cardiac anesthesia and cardiopulmonary bypass. However, the pharmacokinetics of sevoflurane     during CPB have not been investigated so far, although its being used at many hospitals.      The investigators will conduct a randomized prospective study with either sevoflurane or     isoflurane during cardiopulmonary bypass surgery. The study will help to answer the questions     about the possible cardioprotective effects of the widely used volatile anesthetics and the     hemodynamic stability during cardiopulmonary bypass. Knowing the pharmacokinetics of these     drugs allows the anesthesiologist to titrate the volatile anesthetics more precise.      The investigators hypothesizes that the maximal postoperative increase in troponin T will be     smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes     that the total amount of noradrenaline needed during the entire period of cardiopulmonary     bypass will be smaller in the sevoflurane group than in the isoflurane group. The     investigators hypothesizes that kinetics of washin and washout at the CPB will be faster in     the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the     time to extubation, respectively the length of stay in intensive care unit and hospital is     shorter in the sevoflurane group than in the isoflurane group.   "
128602|NCT01601782|"     Determine if volume imaging can diagnose bone, ligament, muscle injuries.   "
128603|NCT01601769|"     Object of the study is the evaluation of the use of a rigid laparoscope for the diagnosis and     therapy of lesions of the female genital tract as a substitution or a complementary method to     colposcopy with the development of new standards for a tissue sparing therapy Use of existing     laparoscopic instruments, which allow a better quality level in the diagnosis and therapy     than the current routine.      Development of new optics and instruments, which allow a tissue sparing approach Pre and     postoperative measurement of the cervical volume, to be sure that the tissue removal is kept     to a minimum level Development of qualitaty parameters for the most tissue respecting     operations of the uterine cervix Prospective evaluation of the influence of tissue sparing     surgery on future pregnancies   "
128604|NCT01601756|"     Hypothesis: navigated revision total knee arthroplasty results in a more precise     reconstruction of preoperatively planned joint line than conventional revision total knee     arthroplasty (rTKA).   "
128605|NCT01601743|"     The purpose of this study is to test the effects of exercise on cocaine use, fitness, and     cravings for cocaine and nicotine. This study is part of an effort to develop treatments for     cocaine abuse.   "
128606|NCT01601730|"     The purpose of this study is to improve the efficacy of modafinil as a potential treatment     for cocaine dependence.   "
128607|NCT01601717|"     The purpose of this study is to evaluate the safety and efficacy of RTI-336 as a treatment     for methamphetamine (METH) dependence in non-treatment-seeking METH-dependent volunteers.   "
128608|NCT01601704|"     The purpose of this study is to determine the effects of NB relative to placebo on major     adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial     infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of     having these events because they have diabetes and/or other cardiovascular risk factors.   "
128609|NCT01601691|"     The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a     spacer between prostate and rectum in prostate cancer low dose brachytherapy.   "
128610|NCT01601678|"     The aim of this study is to compare short and long-term feasibility, safety and efficacy of     endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.   "
128611|NCT01601665|"     The purpose of this study is to evaluate the use of toric high cylinder power intraocular     lenses in a larger population in clinical practice and assure the continued safety of these     approved devices.   "
128612|NCT01601652|"     The study will evaluate the safety and efficacy of an intravenous fish oil emulsion     (omegaven) in infants with parenteral nutrition associated cholestasis.   "
128613|NCT01601639|"     The investigators goal is to compare the standard argon plasma coagulation (APC) treatment     with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.   "
128614|NCT01601626|"     There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment     regimens for HIV-related tuberculosis (TB) among patients who require protease     inhibitor-based antiretroviral therapy. This study will compare three alternative     co-treatment options among participants in high TB endemic resource-constrained settings, in     which one co-treatment option explores if an additional anti-HIV drug needs to be used when     patients are being treated with a protease inhibitor together with rifabutin-based anti-TB     treatment.      Accrual will take place in two accrual periods. Accrual period 1 will enroll 60 participants     who will undergo an initial dose-finding period before continuing regular study follow-up.     Once the review of the dose-finding pharmacokinetic and safety data from accrual period 1     participants is completed, accrual period 2 will begin.   "
128615|NCT01601613|"     This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of     activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with     Dengue haemorrhagic fever (DHF).   "
128616|NCT01601600|"     The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal     muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly     adults with sarcopenia and mobility limitations. In addition, this study will generate data     on the safety, tolerability, and pharmacokinetics of BYM338 in older adults and its response     on additional physical function measures in this population. Furthermore, the extended study     duration will provide information on the stability of BYM-induced changes in skeletal muscle     and patient function in this subgroup of the older population.   "
128628|NCT01601444|"     Early detection of pleural effusion (PLE) would improve the treatment. However, preclinical     detection of pleural effusion is often not possible.      Radiographic examination, widely used for detecting pleural effusion ,is not suitable for     prolonged monitoring of patients at high risk of developing PLE especially ambulatory or at     home The currently available methods for monitoring and early detection such as the     measurement of pulmonary capillary wedge pressure or measurement by double indicator     thermodilution, are not reliable enough and may themselves lead to complications.      Measuring internal thoracic impedance (ITI), the main component of which is lung impedance,     is a noninvasive and safe method. PLE will be diagnosed in accordance with well-accepted     clinical signs(dyspnea, cyanosis, pulmonary rales, crepitations, arterial hypoxemia) and     roentgenological criteria   "
128617|NCT01601587|"     Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities     and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway:     patients are entitled to have influence on their treatment and should receive sufficient     information directed at empowerment. Nevertheless, studies from Norway have found that     patients who seek help are dissatisfied with the information they receive and doubt their     possibility for real influence on their treatment. One way to improve individual PP might be     to give patients sufficient information and education before they start their treatment in     the form of an educational group intervention, an introduction seminar (IS); this group     intervention is less time and resource consuming than individual interventions.      Aims: The main purpose of this project is to develop and evaluate an IS for patients on a     waiting list of DPC. The seminar will educate patients, so they can actively participate in     their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of     treatment. Another aim is to enable patients to participate in their own treatment, to cope     with their problems while they are waiting for treatment by providing them contact with     primary health care and user organizations during their waiting time, and to increase     adherence.      Methods: The project involves three components: an exploratory study of educational content     of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences     and choices, activation, satisfaction, mental health and cost-benefit) and then a     post-seminar qualitative evaluation, which will be used to create a broad yet deep     understanding of the practical side of the participants`experience and the seminar's effect.   "
128618|NCT01601574|"     The purpose of this study is to determine whether the Weight Watchers program modified for     use by people with Type 2 diabetes results in more improvements in blood glucose control     relative to a control group receiving standard diabetes counseling.   "
128619|NCT01601561|"     Background: The hyperinsulinemic-normoglycaemic clamp technique is a precise method of     providing insulin and glucose while maintaining normoglycemia. High-dose insulin has profound     effects on glucose and protein metabolism. It has been demonstrated in coronary artery bypass     graft (CABG) surgery patients that high-dose insulin causes hypoaminoacidaemia. The     investigators hypothesize that the reduction of plasma amino acids (AAs) levels as seen in     patients undergoing CABG surgery and receiving high-dose insulin is a consequence of an     inhibition of whole body proteolysis as assessed by L-[1-13C]leucine tracer kinetics.      Objective: The present study aims to investigate the effect of high-dose insulin therapy on     whole body protein, glucose and end-organ metabolism in patients undergoing CABG surgery     using stable isotope tracers [6,6-2H2]glucose, L-[1-13C]-leucine and L-[2H5]phenylalanine.     The changes in the metabolic-endocrine milieu will also be evaluated by plasma concentrations     of glucose, lactate, free fatty acids, prealbumin, albumin, fibrinogen, insulin, glucagon,     and cortisol.      Methods: With the approval of local institution's ethical committee, 30 patients scheduled     for elective will be enrolled. The patients will be divided randomly into two groups. The     control group will receive a standard IV insulin protocol with the aim of keeping blood     glucose < 10 mmol/L. The treatment group will be administered a high dose insulin infusion of     5 mU/kg/min coupled with a variable infusion of glucose to maintain normoglycemia (4-6     mmol/L). Insulin infusion will be continued until the end of the study period approximately 8     hours after surgery. L-[1-13C]leucine and [6,6-2H2]glucose kinetics will be used to assess     changes in whole body protein and glucose kinetics. Hepatic albumin synthesis will be     determined by using primed continuous infusion of L-[2H5]phenylalanine. The preoperative     measurements will be performed on the morning before the surgery. Postoperative studies will     be conducted two hours after arrival in the intensive care unit. Tracer kinetics between the     two groups will be analyzed using ANOVA for repeated measurements.      Significance: High-dose-insulin results in a significant reduction in plasma AAs in cardiac     surgery. This study should address if this drop in plasma AA levels is secondary to a     decrease in breakdown, an increase in synthesis or both during high-dose insulin therapy in     open heart surgery.   "
128620|NCT01601548|"     Upon the completion of aggressive chemotherapy and radiation for curative intent cancers,     many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as     hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety.     Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body     interventions are defined as practices or interventions that focus on the connection and     integration of the mind and body and the ability for these connections to effect changes on     physical, emotional and spiritual levels for the purpose of promoting health and well being.   "
128621|NCT01601535|"     The goal of the first part of this clinical trial (Phase I portion) is to study the side     effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to     standard chemotherapy drugs, irinotecan and temozolomide.      The goal of the second part of this clinical trial (Phase II portion) is to learn how many     children and young adults show improvements in their neuroblastoma when treated with the     combination of MLN8237, irinotecan, and temozolomide.   "
128622|NCT01601522|"     The purpose of the study is to determine how a type of treatment for peanut allergy known as     oral desensitization works in the immune system.   "
128623|NCT01601509|"     Nasal resistance presents considerable variations during night[8]. Additionally, Oral and     oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas     [7].The hypothesis that the present study aims to test is whether the pharmacological     prevention of increased nasal resistance during night could alter breathing route pattern and     lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal     resistance.   "
128624|NCT01601496|"     The purpose of the study is to evaluate the safety and efficacy of the the FUSION™ Vascular     Graft.   "
128625|NCT01601483|"     This is a Phase II/III vehicle controlled, double masked, single center study. A single eye     of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD)     will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2     years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for     these patients.      An analysis of the primary and secondary endpoints will be conducted when all subjects have     completed 12, 18 and 24 months.   "
128626|NCT01601470|"     This study was conducted to investigate the potential for a pharmacokinetic drug-drug     interaction in support of the co-administration of LCZ696 and sildenafil.   "
128627|NCT01601457|"     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of     activated recombinant human factor VIIgiven in conjunction with standard therapy in patients     undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular     fractures.   "
128629|NCT01601431|"     This is a research study about the usefulness of transparent cap during screening     colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the     tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will     improve the detection of adenomatous polyps (polyps which can become colon cancer later on)     in comparison to the standard colonoscopy.   "
128630|NCT01601418|"     The objective of the study was to assess the effect of a range of single oral doses of YF476     on pentagastrin-induced gastric acid output in healthy volunteers   "
128632|NCT01601392|"     The purpose of this study will to compare the long-term effect of anodal versus cathodal     transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients.     Forty patients with subacute ischemic stroke will randomly assigned to one of three groups:     Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes     daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor     cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS),     the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at     baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical     excitability will be measured at baseline and after the 6th session in both hemispheres.   "
128633|NCT01601379|"     The purpose of this observational study (this means that no drug is being tested in this     study) is to obtain updated and detailed information about the Gastroesophageal Reflux     Disease (GERD) specificities in European patients. The information about patients suffering     from typical GERD symptoms will be collected in order to establish a classification of adult     patients profile based on the characteristics of GERD symptoms. This study will only involve     data collection about the disease. The treatment will not be affected by the study.   "
128634|NCT01601366|"     Adenomyosis is a disease entity diagnosed when endometrial glands and stroma deep in the     myometrium are associated with surrounding myometrial hypertrophy. The finding classically     associated with adenomyosis is excessive uterine bleeding accompanied by worsening     dysmenorrhea. The advent of endovaginal US has substantially improved the ability to diagnose     adenomyosis. Different US features of adenomyosis have been reported, including uterine     enlargement not explainable by the presence of leiomyomas, asymmetric thickening of the     anterior or posterior myometrial wall, lack of contour abnormality or mass effect,     heterogeneous poorly circumscribed areas within the myometrium, anechoic lacunae or cysts of     varying sizes, and increased echotexture of the myometrium.      Transvaginal power Doppler application is useful in studying the vascular tree of adenomyosis     and can aid clinicians in planning the most appropriate therapeutic strategy. The     differential diagnosis using power Doppler sonography is based on vascular characteristics.     Adenomyosis is characterized by a preserved vascular texture supply that results in dilated     spiral arteries running perpendicular toward the myometrium into the endometrial surface.     Leiomyomata exhibits a vascular tree that typically circumscribes the solid mass. 2D     transvaginal power Doppler angiography should be used to improve diagnostic sensitivity and     facilitate appropriate therapeutic intervention.      The levonorgestrel-releasing intrauterine system (IUS), Mirena, has been approved in Europe     for contraception since 1990. Because of the suppressive effect of levonorgestrel on the     endometrium, Mirena has also been proven to be effective for the management of menorrhagia     and dysmenorrhea, and as a progestin component in postmenopausal hormone therapy. It was     introduced in Taiwan in 1995 as an alternative therapy for idiopathic menorrhagia. Many cases     of menorrhagia are caused by adenomyosis, and Mirena was, therefore, introduced for the     treatment of adenomyosis in Taiwan.      The current study is designed to evaluate the best treatment modality for treatment of     adenomyosis clinical by assessment of dysmenorrhea and or chronic pelvic pain by visual     analogue scale and menstrual blood loss by menstrual diary, imaging by ultrasound and Doppler     indices.   "
128635|NCT01601353|"     The purpose of this study is to evaluate the safety and efficacy of adipose derived cells for     the treatment of erectile dysfunction symptoms.   "
128636|NCT01601340|"     The purpose of this study is to evaluate the effects of HQK-1001 on Hb F in subjects with     sickle cell disease.   "
128637|NCT01601327|"     The aim of the present study was to demonstrate the influences of three different treatment     strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic     hypogonadotropic hypogonadism (IHH).   "
128638|NCT01601314|"     The purpose of this study is to determine the relationship between magnesium sulphate     administration and levels of S100B protein in serum of patients undergoing supratentorial     brain parenchymal resection.   "
128640|NCT01601288|"     The purpose of this study is to create a prospective database of all patients who have     undergone pulmonary function testing from which the investigators can study the clinical     phenotypes of various respiratory conditions. The investigators hope by understanding the     differences in these myriad phenotypes to be able to provide individualized, patient-targeted     therapy in the future.   "
128641|NCT01601275|"     Prospective data collection of all patients with microbiologically proven mycobacteria     tuberculosis infection treated at Singapore General Hospital.   "
128642|NCT01601262|"     Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of     new blood vessels. The investigators hypothesized that LISW therapy could improve the     symptoms of patients with erectile dysfunction resulting from a problem of blood supply who     respond to oral therapy (PDE-5 inhibitors). The current study will check the Efficacy and     Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were     Partial Responders to the Initial Treatment.   "
128643|NCT01601249|"     Selecting one or two IVF embryos with the highest potential to implant is extremely important     for the success of the treatment- obtaining pregnancies and avoiding multi-fetal gestations.     The currently used IVF embryo grading method is based solely on embryo morphology (cleavage     rate and fragmentation) just before the transfer, which is not very well correlated with the     implantation potential of each embryo. Oocyte quality and adequacy are the most important     factors determining the biological quality and implantation potential of the embryo. It     impossible to grade oocytes using plain optical systems, other than maturity and gross     anomalies.      Polscope systems allow to visualize intra ooplasmic structures and determine their     retardance, as well as that of the Zona Pellucida. The investigators hypothesize that grading     embryos using the oocyte's parameters as visualized by polscope is superior to conventional     morphology and correlates better with their implantation potential.      Here the investigators will perform a prospective randomized controlled trial to examine this     hypothesis.   "
128657|NCT01601067|"     Comorbidity of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common.     Currently available treatments often do not lead to sustained recovery from these disorders,     possibly because they typically do not include exposure therapy which is considered best     practice treatments for PTSD. This study compares exposure-based integrated treatment to     integrated coping skills psychotherapy (a well disseminated practice) for comorbid AD and     PTSD with the hypothesis that exposure therapy will allow those with PTSD to better sustain     PTSD symptom reduction and reduction in alcohol use. The aim of this grant is to change     common treatment practices for comorbid AD and PTSD by increasing the availability of     evidence-based PTSD treatment for those with AD.   "
128754|NCT01599806|"     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to     Doripenem for treating hospitalized patients with complicated urinary tract infections,     including acute pyelonephritis   "
130327|NCT01579123|"     The reason the investigators are doing this study is to compare the results of laser     atherectomy versus angioplasty with or without the placement of a stent in the artery. A     stent is a metal tube used to open up narrow arteries in the body.   "
128644|NCT01601236|"     This Phase 2A study is an adaptive design pilot study investigating the efficacy and safety     of daily Acthar administration in diabetic patients with nephropathy and proteinuria.     Patients with type 1 diabetes mellitus (T1DM) or T2DM who currently take insulin will be     enrolled and randomized into 6 study groups and will be treated with either Acthar or Placebo     for 36 weeks, followed by a 4 week dose taper, and a 12 week observation period. The study     will compare three dose regimens of Acthar (8 U [0.1 mL], 16 U [0.2 mL], and 32 U [0.4 mL])     to equivalent volumes of Placebo to ensure the double-blind nature of the study.      Insulin-requiring patients are being enrolled to aid compliance with the daily SC     administration of study medication and to allow for ease of blood glucose control by     adjustment of current insulin therapy in the event of glycemic excursions. Routine safety     measures, including glycemic control, will be monitored throughout the study. The adaptive     design component of the study allows for the re-assignment of the high dose group to the mid     dose group if unacceptable toxicity is noted as per study protocol in the high dose group.     Efficacy will be assessed by monitoring serum creatinine, calculated eGFR, and proteinuria     (via urinary protein to creatinine ratio [PCR]). Serum cortisol concentration and additional     biomarkers in blood and urine will also be monitored.   "
128645|NCT01601223|"     Objectives        1. To characterize mechanical ventilation practices during general anesthesia for surgery        2. To assess the dependence of intra-operative and post-operative pulmonary complications          on intra-operative Mechanical Ventilation (MV) settings   "
128646|NCT01601210|"     The purpose of this study is to see if creatine, which is a naturally occurring chemical in     the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.      The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate     for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr)     concentrations.   "
128647|NCT01601197|"     Immunization injections are a significant source of pain for infants. Tactile stimulation     (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it     is cost neutral, and has been shown to be effective in children and adults undergoing     injections. The aim of this study is to determine the added benefit of tactile stimulation     when added to other proven analgesic interventions during routine infant immunization     injections.   "
128648|NCT01601184|"     The purpose of this study is to evaluate the safety of vismodegib in combination with     temozolomide (primary objective - phase I) and to estimate the efficacy of vismodegib in     combination with temozolomide in adult patients with recurrent, progressive, or refractory     medulloblastomas to standard therapy measured by the 6-month progression-free rate (phase     II).      This study is an open-label Phase I/II, international, randomized.      38 patients will be included in the study.   "
128649|NCT01601171|"     The purpose of this study is to explore the genetic basis of reproductive disorders.   "
128650|NCT01601158|"     This open-label study aims to evaluate the safety and efficacy of umbilical cord blood     therapy for children with global developmental delay.   "
128651|NCT01601145|"     The aim of the present research protocol was to evaluate the effect of probiotics daily used,     on the plaque acidogenicity of children. The null hypothesis was that the plaque     acidogenicity would remain unchanged and not associate with the use of probiotics. Moreover,     the in situ study will be carried out to investigate the plaque formation as biofilm in     demineralised enamel specimens following the regular consumption of a probiotic product     compared to a control group. Metabolic of the biofilm formed on of the enamel specimens     resulting from the consumption will be evaluated over a period of 8 weeks.   "
128652|NCT01601132|"     Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe     substrate. When the two are co-administered the potential exists for a clinically significant     drug interaction. This study aims to determine the effect of steady-state colchicine on the     pharmacokinetics of theophylline administered as a single dose. A secondary goal is to     evaluate the safety and tolerability of this regimen in healthy volunteers. All study     subjects will be monitored for adverse events throughout the entire study period.   "
128653|NCT01601119|"     The objective is to establish the impact of current disease modifying therapies (DMTs) and     associated support services on Patient Reported Experience Measures and Patient Reported     Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the     United Kingdom (UK).   "
128654|NCT01601106|"     Cardiovascular disease(CVD) is the leading cause of morbidity and mortality in developed     nations. CVD is primarily caused by atherosclerosis, a systemic disease characterized by     lipid deposition in the subendothelial space with a concomitant, low-grade inflammatory     reaction.(Fuster, Moreno et al. 2005) To date, most therapeutic interventions aimed at     lowering CVD have thus far focused on modulating lipid levels, either lowering LDLc or     increasing HDLc levels. Yet, since the introduction of statins 20 years ago, there have been     few breakthroughs in the treatment of this disease. A promising strategy to reduce CVD is to     directly target inflammation at the level of the vessel wall.(van Leuven, van Wijk et al.;     Libby 2002) A potential drawback of anti-inflammatory strategies pertains to the thin line     between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression.     Therefore, continuous low dosed anti-inflammatory drugs have great potential as novel     treatment strategies. In the present project, the investigators propose to inject liposomal     glucocorticoids intravenously in patients with an increased risk of atherosclerotic disease     aiming to reduce vessel wall inflammation.   "
128655|NCT01601093|"     In the proposed study, the investigators plan to evaluate the efficacy and safety of     Ceftazidime Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory     and urinary tract acute bacterial infection.   "
128656|NCT01601080|"     This is an observational, retrospective, UK & Ireland audit measuring patient adherence to     Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple     Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™     device for injection for a minimum of 24 months.   "
128708|NCT01600404|"     Prospective evaluation of the cognitive function of in-house patients suffering from an acute     traumatic spinal cord injury before and three months after the initiation of antimuscarinic     treatment.      The following hypothesis will be tested: Antimuscarinic treatment results in significantly     worse cognitive test results three months after traumatic spinal cord injury compared to the     pre-treatment results and the results of the control group.   "
128658|NCT01601054|"     Within the last decade there has been an increase in the number of surgical procedures for     deformities of the spine. This is caused by the increase in the elderly population, improved     surgical techniques and an increased number of patients who have undergone previous surgical     treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities     bears a revision rate between 15 and 30% depending on definition, and one of the primary     reasons for revision surgery is implant loosening in the lumbosacral region.      The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar     spine in addition to the usual posterior instrumentation can reduce the revision rate with     50%.   "
128659|NCT01601041|"     The purpose of this prospective study is to investigate the association between the amount of     residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent     (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year)     spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing     intermittent catheterization.      The following hypotheses will be tested:        1. The amount of residual urine after intermittent catheterization is significantly greater          in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to          those without.        2. The incidence of asymptomatic bacterial prostate infections is significantly higher in          SCI patients suffering from frequent (>2 /year) urinary tract infections compared to          those without.   "
128660|NCT01601028|"     Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with     dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome     patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren     syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies     have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no     randomized controlled study has been done. So the investigators evaluate the effectiveness     and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled     study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N =     30).   "
128661|NCT01601015|"     Background. Tension-type headache (TTH) is the most common form of primary headache and it is     a real problem for the subjects suffering from it. Until now, physiotherapy treatments have     included different techniques combined together, without establishing which of them is more     effective.      Objective. The purpose of this study is to know the effectiveness of manipulative and manual     therapy treatments, with regard to pain perception and neck mobility in patients with     tension-type headache.      Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed     with tension-type headache, divided into three treatment groups -manual therapy, manipulative     therapy, and a combination of both techniques-, and a placebo control group. Four treatment     sessions were administered during four weeks, with post-treatment assessment, and follow-up     at one month. Cervical ranges of motion were assessed (CROM device), as well as pain     perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly     register).   "
128662|NCT01601002|"     Patients with an episode of depression in late life prescribed mirtazapine recruited from a     clinical sample will be monitored for weight and receive a blood test during their usual     course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect     weight gain.   "
128663|NCT01600989|"     Introduction: Evidence suggests that sepsis and septic shock severely impair mitochondria and     that the resulting mitochondrial dysfunction is related to the severity and outcome of the     resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and     ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal     and heart muscle tissue and blood cells. Circulating immune cells play an important role in     the pathophysiology of sepsis. Stimulation of the immune system alters the energy     requirements of immune cells; down-regulation of immune-cell activity has been associated     with prolonged sepsis and unfavourable outcome. The aim of the project is to comprehensively     investigate changes in mitochondrial function of immune cells in patients with severe sepsis     and septic shock. The following main hypotheses will be evaluated:        -  Severe sepsis and septic shock leads to increased energy requirements of immune cells          and to an increase in mitochondrial enzyme activities and energy production.        -  Changes of mitochondrial function in human immune cells are associated with alterations          in clinical and laboratory markers of severity of sepsis.        -  Prolonged sepsis and unfavourable outcome is associated with down regulation of          mitochondrial function.      Methods: A total of 30 adult patients admitted to the intensive care unit (ICU) due to severe     sepsis or septic shock will be included in the study; 30 healthy volunteers serve as     controls. Patients with any type of chronic infectious, inflammatory or autoimmune diseases,     after transplantations or receiving immunosuppressive agents are excluded.      Collected baseline characteristics include patient demographics, diagnosis and severity of     illness scores at the time of admission. Daily collected follow up data include clinical and     laboratory parameters of organ dysfunction, use of vasopressors/inotropes, use of     antibiotics, use of steroids and results of microbiological cultures/stains.      Negative identification and isolation of monocytes, B cells and CD4 T cells will be performed     daily from ICU admission to discharge using an antibody-antigen mediated immunomagnetic cell     isolation procedure that depletes all blood cells except the specific target cells.     Mitochondrial function of immune cells will be assessed by measurement of mitochondrial     complex activity for complexes I to IV by a standard titration protocol. Additionally, the     levels of pro- and anti-inflammatory cytokines (Interleukin (IL)-1, IL-6, IL-10, TNF-α) will     be assessed throughout the stay in the ICU. For comparison mitochondrial function of of     monocytes, B cells and CD4 T cells and cytokine levels will be measured in a group of 10     healthy volunteers.      Analysis plan: Changes in mitochondrial function of immune cells over time compared to a     healthy control group and during the course of severe sepsis and septic shock is the main     outcome parameter of this study. Assessed predictors are determined by the severity of the     underlying septic condition and include clinical and laboratory evidence for dysfunction of     vital organ systems and changes in levels of inflammatory and anti-inflammatory cytokines.   "
128664|NCT01600976|"     The purpose of this study is to determine whether the pharmacokinetic (what the body does to     the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment,     compared to the pharmacokinetic parameters in patients with normal liver function, and     measure the relative unbound plasma concentrations of telaprevir.   "
128665|NCT01600963|"     The purpose of this study is to provide safety and efficacy data for TMC207 and to     demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the     BR plus placebo.   "
128666|NCT01600950|"     The study involves a single injection of LY2963016 and a single injection of Lantus, on 2     separate occasions in participants with type I diabetes. Following each dose, participants     will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7     days between the two periods, during which time there will be no study treatment, but     participants will resume their regular therapy. The duration of this study can be up to 9.5     weeks. The purposes of this study are to understand how the blood sugar lowering effect of     LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are     metabolized by participants with type I diabetes.   "
128786|NCT01599390|"     The study will assess the burden of severe influenza outcomes by age, risk status, and     influenza subtype, in order to create a profile of the burden of influenza-related morbidity     and mortality in United States from July 1997 to April 2009.   "
128667|NCT01600937|"     Current guidelines recommend supervised mixed (aerobic+resistance) physical activity to     ensure optimal benefits to control blood glucose, lipids, blood pressure, and other     cardiovascular risk and to minimize injuries. However, these guidelines are difficult to put     into action for a number of barriers and poor long-term patient compliance. This project will     assess the effect of a behavioral intervention strategy on the promotion and maintenance of     physical activity in type 2 diabetes.   "
128668|NCT01600924|"     This project will assess the independent predictors of impaired muscle and bone strength     through a longitudinal observation of a cohort of subjects with type 1 and 2 diabetes     consecutively attending an outpatients diabetes clinics for the annual screening of     complications.   "
128669|NCT01600911|"     Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients     and non-nutrients still remains to be discovered.We design a feeding study which provides     plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The     goal of this study is to establish a protocol for documenting metabolomics response to plant     foods and try to characterize plant foods in terms of their anti-hypertension potentials with     metabolomic profiling information.   "
128670|NCT01600898|"     In this prospective study, the investigators will implement a systematic screening program     and 3-year follow-up in a cohort of asymptomatic BMPR2 mutation carriers. This study is     designed to:        -  determine predictive factors (biological, functional, radiological and hemodynamic) of          development of PAH        -  monitor these subjects' clinical, functional, biological, echocardiographic and          hemodynamic characteristics        -  assess the risk of occurrence of PAH        -  screen patients with PAH at an early stage of disease and offer them an early management        -  constitute a collection of biological samples (0, 12, 24 months follow-up) of          asymptomatic BMPR2 mutation carriers.   "
128671|NCT01600885|"     The purpose of the study is        1. To establish the feasibility of fMRI studies of the interaction of guanfacine and          ketamine.        2. To explore the possibility that guanfacine can ameliorate the negative effects of          ketamine on task-related prefrontal activation.        3. To assess the strength of any interaction between guanfacine and ketamine.   "
128672|NCT01600872|"     Both oxidative stress and Bisphenol A (BPA) had been associated with polycystic ovary     syndrome (PCOS). BPA, one of endocrine-disrupting chemicals (EDCs), is an environmental     estrogen used in the synthesis of plastics, is a high-volume production chemical with     widespread human exposure. BPA was been reported in several female reproductive disturbance.     However, the pathological pathway of BPA impact on female reproductive system had not been     well-understood. Reactive oxygen species (ROS) have a role in the modulation of gamete     quality and gamete interaction. Persistent and elevated generation of ROS leads to a     disturbance of redox potential that in turn causes oxidative stress (OS). The first part of     The investigators study is aim to evaluate the oxidative stress impact on the biochemical     parameters in women with PCOS; the secondary part of the investigators study is to     investigate the BPA on the clinical and biochemical of women with PCOS; finally, the     investigators plan to test the hypothesis that BPA might increase oxidative stress and then     elevated ROS in women with menstrual disturbance, furthermore, the role of oxidative stress     and BPA impact on insulin resistance and metabolic disturbance will be also investigated.      Study and control cases will be included. Serum total oxidant status (TOS), total antioxidant     status (TAS), Bisphenol A (BPA), and clinical/biochemical parameters will be obtained for all     cases. Oxidative stress and BPA will be evaluated with all clinical/biochemical parameters     for all subjects.   "
128673|NCT01600859|"     Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild     cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking     thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor     (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to     Screening and remain on their stable dose throughout the trial. Subjects will receive placebo     or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the     pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid     biomarkers and cognitive and psychological measures.   "
128674|NCT01600846|"     The purpose of this study is to further integrate pharmacogenetic (PGx) testing into clinical     practice by educating physicians about pharmacogenetics and offering testing to their     patients. Pharmacogenetic testing may help physicians choose the best drug and dosage for     their patients which can reduce side effects, increase effectiveness, and improve patient     adherence.      Two clinics will be involved. One clinic will have a pharmacist on-site as a resource to     physicians and to advise what patients may benefit from PGx testing; the other clinic will     have a pharmacist on call.      Patient and physician perspectives about PGx testing and their utilization will be examined     via surveys.      The investigators hypothesize that with education about PGx testing, more physicians will     utilize testing.   "
128675|NCT01600833|"     The purpose of this study is to study the association of serum ferritin and homocysteine     levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome     The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women     with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term     consequence of women with PCOS. Recent evidence suggests that increased body iron might be     involved in the pathogenesis of insulin-resistance disorders, furthermore,     hyperhomocysteinemia is associated with an increased risk of atherosclerotic and     thromboembolic disorder. The investigators plan to retrospectively review the medical records     of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical     Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.   "
128676|NCT01600820|"     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable     low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly     hypercholesterolemic subjects treated or not by statins.   "
128752|NCT01599832|"     The purpose of this study is to find out what effects pazopanib (pazopanib hydrochloride)     (also called Votrient®) may have on MRI (magnetic resonance imaging) scans, blood pressure,     and various proteins in the blood. Pazopanib is Food and Drug Administration (FDA) approved     for treating renal cell cancer. It is an agent that prevents angiogenesis, which is new blood     vessel formation. The use of pazopanib described in this study is a standard of care, but the     additional MRI and blood tests that will be performed are experimental   "
128677|NCT01600807|"     OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been     used in other research studies and information from those suggests that OSI-906 may help     block cell receptors involved in tumor growth.      Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this     research study, the investigators are looking for the highest dose of OSI-906 that can be     given safely in combination with gemcitabine and erlotinib. This dose will then be given     together with gemcitabine and erlotinib to a further group of patients with pancreatic     cancer.   "
128678|NCT01600794|"     Because the society convention is changed, people are late for getting married, leading to     increasing the bearing age in women. According to the previous study, if the age is over 30,     the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is     collected by Bureau of Health Promotion, Department of Health shows that there are about 7000     people treating the infertility and it spends about 150000 to 250000 NT dollars in every in     vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is important to     know how to estimate and approve the ovary function that lead to increase the live birth     rate. The investigators plan to estimate the correlation between the serum androgens levels     and pregnancy outcome in the women who have infertility problem. Furthermore, for the     repeated IVF cycle, the ovary function might be re-evlauated because of the possible effect     from stimulated drugs used on previous cycle. It's important to understand the ovary function     for IVF patient to choose the appropriate drugs and dose.      The investigators use blood and clinical test to analyze, the items for analysis are below:        1. Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、        2. Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S        3. Clinical test: Ultrasound        4. Personal condition. In order to finishing the test, every patient will be asked to          collect about 10 to 15 cc blood for the research.   "
128679|NCT01600781|"     This is a randomised, controlled, open-label intervention study. It is hypothesized that     supplementation with a fibre enriched sip feed will improve the nutritional status, gut     microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may     enhance their immune response. This could give them a better chance to finish their induction     chemotherapy successfully with fewer side effects.   "
128680|NCT01600768|"     The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of     extended infusion of beta-lactams in intensive care patients who are infected with     Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).   "
128681|NCT01600755|"     The aim of this clinical study is to investigate the safety and feasibility of Autologous     Muscle Derived Cells (AMDC; a preparation of a patient's own cells) injection into the anal     sphincter for treatment of patients with fecal incontinence.   "
128682|NCT01600742|"     Vorinostat is a potent and well tolerated HDAC inhibitor. It has been reported to enhance     radiosensitivity of cancer cells. We hypothesize that the addition of vorinostat to WBRT may     increase therapeutic efficacy for patients with brain metastases.   "
128683|NCT01600729|"     This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle     Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.   "
128684|NCT01600716|"     This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the     treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.   "
128685|NCT01600703|"     Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon     like peptide 1) reduces intestinal production of lipoprotein particles. The investigators     therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will     reduce intestinal lipoprotein production in humans. The investigators are unable to speculate     whether sitagliptin will affect hepatic lipoprotein production because of lack of of data     from animal studies or in vitro data. Sitagliptin is already an approved treatment for type 2     diabetes.   "
128686|NCT01600690|"     Statins are commonly prescribed to lower cardiovascular risk in primary and secondary     prevention. Despite their well known efficacy, statin withdrawal is a common event. Even a     short term statin withdrawal can have dramatic consequences on atherosclerotic plaque     stability, owing to a rebound in cholesterol levels and inflammation.      The effects of a short term statin withdrawal on endothelial progenitor cells (EPC) and     monocyte/macrophage polarization is unknown.      In this study, the investigators will explore the effects of a 5-day statin withdrawal on EPC     and monocyte/macrophage polarization, together with other inflammatory biomarkers in type 2     diabetic patients. The investigators hypothesize that statin withdrawal determines a     reduction in EPC levels and an inflammatory cell polarization.      Patients will be randomized to continue their habitual statin regimen or to withdraw statin.     At baseline and 5 days later, blood samples will be collected for experimental measures.   "
128687|NCT01600677|"     The research study is a randomized controlled trial (RCT). The primary endpoint is to compare     medication adherence of adult patients recently hospitalized with a diagnosis of common     cardiac conditions who require medication assistance either by receiving usual care or by     using a medication delivery unit. The overall study will last a total of 12 months. Each     subject will be enrolled for a period of 90 days.   "
128696|NCT01600560|"     With the surge in use of electronic media among adolescents, a strategy that has been     utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents.     To date, no published study has looked at the effectiveness of texting adolescents themselves     (especially boys) rather than their parents OR compared texting to social network sites to     increase HPV knowledge and uptake of HPV vaccination in boys. Interactive technology-based     interventions targeted at youth are feasible in North Carolina for the following reasons: (1)     through the NC Minors' Consent Law adolescents can consent to the prevention, diagnosis, and     treatment of sexually transmitted diseases (N.C. Gen. Stat. § 90-21.5(a); and (2) many school     based health centers can provide immunizations. Since HPV infection is a sexually transmitted     infection, NC teens do not have to get consent for HPV prevention (i.e., vaccination).      To optimize HPV vaccination in young people, especially males, communication strategies are     needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated to     be a feasible, popular, and effective method of sexual health promotion to young people with     a relatively low withdrawal rate, positive feedback, and an observed improvement in sexual     health knowledge and STI testing (12). Social media communication strategies are a new and     potentially effective channel for communicating public health messages about HPV vaccine that     are also likely to increase HPV initiation and completion among adolescent girls in addition     to boys.      According to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13 had     received at least one dose of HPV vaccine. In the investigators continuity clinic less than     50 percent of adolescents are fully immunized. This project will identify social behavioral,     emotional, and cognitive correlates and predictors that help explain why teens pursue,     complete, and do not complete HPV vaccination, and develop a social media communication     intervention collaboratively with teens to increase HPV vaccine initiation and completion.   "
128688|NCT01600664|"     A randomized controlled study to evaluate the effect of 3 months use with interactive     computer game- My Diabetic Friend- comparing to conventional diabetes education on     metabolic control, quality of life and diabetes knowledge.Patients will be randomized into     two groups- one group will be supplied with interactive computer game, My Diabetic friend,     installed on a computer designed for children's educational needs for a period of three     months and the other group will be supplied with the same computer without the interactive     computer game for three months. Metabolic control, quality of life and diabetes knowledge     will be evaluated before and after the use of the computer.      The trial is consisting of two main periods: 3 months of the main study period and an     optional extension period consisting of the following 3 months :      The study will include two main periods;        1. Period 1 which will last 3 months, in a randomized controlled manner, this period will          serve as the main study period to assess the primary and secondary endpoints of the          study.        2. Period 2: this extension period will not be an integral part of the study, and only          patients who are willing will take part at this period, will continue to participate at          the optional extension period. During the extension period, patients in the intervention          group will be offered to continue the use of the Computer game -My diabetic friend) for          the following 3 months, and patients who participated at the control group during period          1, will be offered to start to use the Computer Game - My Diabetic Friend for the          following 3 months.   "
128689|NCT01600651|"     RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar     epithelial type I cell injury, and soluble RAGE (sRAGE) is elevated in the plasma and in the     pulmonary edema fluid from patients with ALI/ARDS. Few data are available about the influence     of ventilatory interventions on levels of sRAGE in the setting of ALI/ARDS. The purpose of     this prospective monocentric randomized controlled cross-over study is to describe the     effects of a recruitment maneuver (RM) on plasma sRAGE levels during diffuse ARDS.   "
128690|NCT01600638|"     The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the     CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with     sharp body curvature.   "
128691|NCT01600625|"     One of the important factors in obtaining successful outcomes when treating severe meibomian     gland dysfunction (MGD) is to control the existing ocular and eyelid inflammation. Thus, in     previous studies, topical and systemic antibiotics with anti-inflammatory function, such as     topical azithromycin, systemic tetracycline, doxycycline and minocycline, have been used to     treat severe MGD. In this study, minocycline which had the fewest side effects was used to     evaluate the effect on cytokine levels in severe MGD. At study initiation, all patients     completed an Ocular Surface Disease Index (OSDI) questionnaire and had an ocular surface,     tear, and meibomian gland evaluation that consisted of fluorescein tear break-up time (TBUT),     Schirmer test, corneal and conjunctival fluorescein staining, microscopic examination of lid     margins and meibomian glands, and tear cytokine levels. All measurements except tear cytokine     levels were conducted in the same manner before treatment, after 1 month, and after 2 months     of treatment. Tear cytokine levels were evaluated before treatment and after 2 months of     treatment. The aim of this research was to determine the concentration of inflammatory     cytokines in the tears of patients with MGD and to compare the cytokine levels, corresponding     clinical responses, and ocular symptoms before and after 2 months of treatment with oral     minocycline.   "
128692|NCT01600612|"     Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an     estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of     PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most     conventional drug which was proved effective. However, it has the shortcomings of short half     life and the necessity of intravenous administration. Misopristol, and more recently     Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.      Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin     for treatment of atonic PPH.   "
128693|NCT01600599|"     The purpose of this study is to assess the efficacy of IV Tranexamic Acid and topical     Tranexamic Acid to control post op bleeding following Coronary Artery Bypass Graft Surgery     using Cardiopulmonary Bypass.   "
128694|NCT01600586|"     NICU infants are at high risk for oromotor difficulties including poor coordination of     sucking swallowing and breathing. These feeding difficulties often result in prolonged     hospitalization, with increased physiologic stressors and poor growth. In preliminary     studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor skills and     decreased length of hospitalization.      The investigators propose to test the hypothesis that a week-long PAL intervention can     improve feeding skills and decrease stress compared to standard of care parental interactions     in infants in the late preterm period. The investigators also hypothesize that these     improvements will result in shorter hospital stays and increased growth in the intervention     group.      Our study design is a prospective randomized controlled trial design of 94 NICU infants     (Post-conceptional ages 34-36 weeks) in the Vanderbilt NICU. The 47 intervention-group     infant/mother dads will receive a book library with one lullaby book and record her voice to     the PAL, which the music therapist will then administer in 15-minute sessions for 5     consecutive days. The 47 participants in the control group will receive the same library but     no recording will be made or PAL used. Outcomes measured will include time to full oral     feeds, suck rate and efficiency, salivary cortisol levels before and after intervention,     daily growth parameters and nutritional data, and hospital length of stay.   "
128695|NCT01600573|"     This clinical trial shall clarify the efficacy and safety of pazopanib in combination with     weekly topotecan in patients with platinum-resistant or intermediate platinum-sensitive     recurrent epithelial ovarian cancer, fallopian and peritoneal carcinoma   "
128707|NCT01600417|"     The aim of the study is to evaluate the feasibility and validity of conventional radiographs     of the lumbo-sacral spine when the patient is lying on a special table which facilitates     maximal lumbo-sacral flexion. The results gained from the radiographs with the patient on the     table will be compared with those gained from standard flexion-extension radiographs of the     lumbo-sacral spine.   "
128787|NCT01599377|"     The overall aim of the study is to establish bioequivalence between commercial tofacitinib     tablet formulations with the tofacitinib capsule formulation.   "
128697|NCT01600547|"     Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and     fall increases the risk of fracture. Falls in the elderly are associated with a high     morbidity and mortality with potentially life-threatening consequences of falls including     fractures. Besides fracture fall may cause long term problems such as disability fear of     falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip and     spine. The investigators want to investigate whether other more accessible and less expensive     testing methods can be used to diagnose osteoporosis. Additionally, the investigators will     examine the incidence of osteoporosis among the elderly in the municipality of Odense.     Finally, the investigators would like to investigate the association between factors that can     lead to falls and to investigate the performance of older and whether there are changes in     functional ability over time.   "
128698|NCT01600534|"     This study includes a behavioral educational intervention that focuses on healthy eating and     physical activity during pregnancy and the postpartum among women newly diagnosed with     gestational diabetes mellitus (GDM).   "
128699|NCT01600521|"     The purpose of this study is to evaluate the efficacy and safety of a combined therapy for     rheumatoid arthritis (RA). The combined therapy contained paeoniflorin (Brand name: Pafulin),     which has anti-inflammation properties, and Cervus and Cucumis polypeptide injection (Brand     name: Songmeile), which has bone healing, pain relieving, and anti-inflammation properties.     The hypothesis is that this remedy, which has long been used by the world's largest RA     community, is effective and safe when tested by modern clinical standards and criteria.   "
128700|NCT01600508|"     Background:      Videoconference (VC) is a common clinical tool and has huge potential to alter medical     practice and to offer patients the best expertise in treatment and follow-up in spite of long     distances, especially in rural areas. Studies upon selected patient groups have shown that VC     is safe and cost-effective. However, RCT of VC patients with stoma problems have never been     performed.      Patients with stoma problems are resource demanding patients. The University Hospital North     Norway (UNN) has several hundred consultations for this patient group each year, serving the     population in North Norway.      Methods: In this randomised controlled trial (RCT), patients are either randomised to a VC     consultation or a regular consultation at the outpatient clinic. All patients with a stoma     that needs special attention are eligible for inclusion. Patients randomised to the VC group,     are set-up to a meeting at the nearest VC studio located to their home community. There will     be educated VC- stoma nurses that will participate in the clinical examination at the     hospital outpatient clinic and at the rural VC studio.      Endpoints: Primary endpoints are patient satisfaction and quality of life. Secondary     endpoints are number of consultations and cost effectiveness.      Sample size calculations showed that 170 patients had to be included in the trial.      The investigators hypothesize that postoperative follow-up of stoma patients by VC will not     have any impact on patients' quality of life compared to Hospital outpatient follow-up.     Furthermore, the investigators hypothesize that the incremental cost-effectiveness ratio will     improve.   "
128701|NCT01600495|"     The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical     Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research     will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant     women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be     divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and     will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of     cervical dilation. The evaluation will be performed by numerical category scale, location and     Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a     questionnaire of customer satisfaction.   "
128702|NCT01600482|"     The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and     effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery     access site in patients on anticoagulation who are undergoing a percutaneous intervention     (PCI) procedure using a 6F sheath.   "
128703|NCT01600469|"     NMDA activation plays an important role in learning and memory. NMDA receptors were found to     decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive     function impairment. This study is a randomized, double-blind, placebo-controlled drug trial.     All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group     (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The     investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive     function in patients with mild cognitive impairment or mild Alzheimer's disease.   "
128704|NCT01600456|"     The specific aims of this study are:        1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE)          to that of PE and medication (sertraline).        2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months          post-treatment.        3. To compare those who have chosen their treatment to those who have not in terms of          completion of treatment, treatment satisfaction, and short- and long-term effectiveness          of the treatment.        4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.   "
128705|NCT01600443|"     The study is undertaken to investigate if the urethral microtrauma, caused by intermittent     catheterization, differs between three hydrophilic catheters for intermittent     catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a     prospective, randomised, cross-over, single-centre study.      Each subject will be randomized to use three different catheter types. Three catheterizations     will be performed with each catheter type during one day, with at least two hours between     each catheterization. The washout period between catheter switch will be at least one week.      The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters     with regards to hematuria after intermittent catheterization.      The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters     with regards to pyuria and subjective evaluation after intermittent catheterization.      The safety of the three catheters will be evaluated in terms of adverse advents, non-serious     and serious, rated for causality.      The hypothesis that level of hematuria is equal after using different catheters will be     tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is     less than 5%.   "
128706|NCT01600430|"     The study hypothesis states that giving early enteral Vitamin D supplementation to preterm     infants will decrease respiratory morbidity in extremely preterm infants.   "
128709|NCT01600391|"     Given that visual information comprises one of the most important and salient sources of     information used during walking, that visual cues have been shown to be more effective than     auditory cues in triggering gait adjustments and that stroke survivors have been reported to     become more dependent on visual cues, the investigators hypothesize that visual cues would be     more effective in triggering gait recovery and adaptability following stroke than     interventions not including visual cues.      The investigators will integrate visual cues with walking and turning practice, and contrast     this intervention to routine overground walking practice. Stroke participants recruited from     NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three     gait rehabilitation groups. Each group will receive the same frequency and duration of     treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and     usual care (UC) groups will be treated in participating NHS sites. Treadmill training with     visual cues (TVCT) will take place at the University of Birmingham.   "
128710|NCT01600378|"     The purpose of this study is to generate a prospective database of all patients evaluated for     diffuse parenchymal lung diseases to provide much needed data on the various disease     aetiologies, incidence and prevalence rates, clinical and radiological presentations,     pathologic correlations, disease progression and response to treatment, and final outcomes in     this group of patients in Singapore.   "
128711|NCT01600365|"     The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of     conjunctivitis caused by adenovirus.   "
128712|NCT01600352|"     The purpose of this study is to evaluate the clinical utility of specific autoantibody     testing in unmasking an underlying connective tissue disorder in patients who present with     interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt     connective tissue disease manifestations OR borderline/negative ANA with some clinical     suggestion of connective tissue disease.   "
128713|NCT01600339|"     In this phase II multicenter study, the investigators aim to evaluate the efficacy and     tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for     metastatic urothelial carcinoma.   "
128714|NCT01600326|"     The purpose of this study is to determine the effectiveness of various treatment soft     tendinosis also known as tendinitis.   "
128715|NCT01600313|"     The purpose of this study is to determine the effect of rice bran oil with low calorie diet     on lipid profiles.   "
128716|NCT01600300|"     Hypothesis: external electrical stimulation of the retina with low level electrical currents     improves visual acuity in subjects with age-related dry macular degeneration.   "
128717|NCT01600287|"     The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of     IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual     control using bispectral index in paediatric patients undergoing open heart surgery under     cardio-pulmonary bypass.   "
128718|NCT01600274|"     -  Characterisation of relative bioavailability of Diena (Test) in comparison to Valette®          (Reference) after single dose administration under fasting conditions        -  Assessment of bioequivalence of Test vs. Reference after single dose administration          under fasting conditions, determined by use of area under the concentration time curve          AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and          dienogest (DNG)        -  Descriptive characterisation of safety and tolerability of the investigational products          in the study population   "
128719|NCT01600261|"     Comparison study to assess photo image quality of a new color fundus camera compared to that     of a commercially available color fundus camera.   "
128720|NCT01600248|"     This study will evaluate the usefulness of an online, self-directed treatment for chronic     pain that has been designed specifically for individuals who are currently or have previously     served in the military.   "
128721|NCT01600235|"     The purpose of this study is to evaluate the safety and efficacy of the induced hypertension     using phenylephrine in patients with noncardioembolic ischemic stroke.      The investigators hypothesized that phenylephrine induced-hypertension can result in good     clinical response without serious complications in patients with noncardioembolic ischemic     stroke.   "
128722|NCT01600222|"     A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of     LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.   "
128723|NCT01600209|"     The objective of this study is to confirm the sensitivity and specificity of a stool DNA test     for detection of colorectal cancer and pre-cancer.   "
128724|NCT01600196|"     The purpose of this study is to evaluate the long-term efficacy and safety of surgical     resection compared with best supportive care in patients with resectable hepatocellular     carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.   "
128725|NCT01600183|"     This is a prospective, randomized, control, open label study in which up to 50 subjects with     metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard     casting or using the UNFO-s device for total time of 20 weeks.   "
128749|NCT01599871|"     The main objective of the study is to determine the effects of low-dose oral theophylline     added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid     (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of     exacerbations defined as increase of symptoms that requires a change of medication     (antibiotics and/or systemic glucocorticoid) or hospitalisation.      DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel,     prospective study. Patient will be recruited during an hospitalisation due to COPD     exacerbation and randomised at the time of discharge to receive theophylline 100 mg or     placebo on top of combination therapy with inhaled corticosteroids and long-acting beta     agonist. The rate of exacerbations will be determined every three months up to one year     follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of     them, the following information will be obtained:        -  Number/severity of exacerbations or hospitalisation since last clinic visit        -  Compliance and side effects        -  Blood sample        -  Plasma levels of theophylline        -  Sputum (induced)        -  MMRC        -  SGRQ        -  Forced spirometry + inspiratory capacity           - At the beginning and at the end of the study        -  6MWT        -  BMI        -  BODE   "
128726|NCT01600170|"     HIV associated neurological disorders (HAND), are a major problem even in ART treated people.     HAND results from chronic inflammation which is largely attributed to expansion and     activation of monocytes. These activated monocytes, some of which also carry virus to the     brain, invade the CNS and release cytokines / chemokines resulting in further recruitment of     monocytes, as well as release viral proteins which injure neurons and cause activation of     other brain cells. Persistent monocyte/macrophage activation is thus a potential critical     target for adjunctive therapy to treat or prevent HAND. The investigators therefore propose     to study the effects of a statin drug (Atorvastatin), which has anti-inflammatory functions,     on the monocyte activation status in vitro and in ART treated HIV+ individuals.      The investigators objectives are based on the hypothesis that Atorvastatin treatment will     reduce the inflammatory and activated phenotype and function of monocytes which have been     linked to HIV associated neuropathogenesis and occur in HIV infected subjects despite ART. In     this study the investigators propose to        1. determine how Atorvastatin modulates monocyte activation, intracellular signaling          pathways and functions implicated in the pathogenesis of HAND in vitro        2. define the effect of Atorvastatin on monocyte activation in HIV infected / ART treated          subjects in a double blind, placebo controlled crossover study        3. define gene expression patters of monocyte activation before and following statin          treatment        4. assess Atorvastatin effects on CNS immune activation markers and neurocognitive function          in ART treated subjects.   "
128727|NCT01600157|"     Background Fast-track concepts reduced hospital stay from 15-20 days to three days for     patients who underwent a colon resection [1-5]. A well-designed pilot study determined the     efficacy of a fast-track program for a laparoscopic radical nephrectomy, and the fast-track     group was discharged earlier from the recovery room median (74+/-23 v 103+/-47 minutes) as     well as from the hospital median (41+/-11 v 59+/-11 hours) [6]. Implementation of the     principles of the fast-track program shortened the postoperative hospital stay from eight to     four days for patients who underwent an open radical nephrectomy [7]. Taek-Gu Lee et al.     documented how early mobilization after colon surgery resulted in reduced recovery times     without increased complications [8]. Laparoscopic surgery is minimal invasive with less     surgical stress, morbidity and mortality [9]. The use of laparoscopic nephrectomy in Denmark     reduces the hospital stay to 5.2 days which did not meet the foreign countries outcome [06].      Therefore a combination of the advantages of laparoscopic surgery and the fast-track concepts     could be used by nephrectomies. However, no prospective studies describing the course after     nephrectomies, where these advantages are exploited and it is important to make a basic study     to describe and understand the factors of surgical outcome.      Aim of study To describe the postoperative period after laparoscopic trans-peritoneal     nephrectomy that performed as an ambulatory procedure.      Method A prospective study will involve 62 patients who have been diagnosed with Cancer Renis     DC649.      All patients will receive the results of CT-scanning at outpatient and of them who meet the     inclusion criteria for the study will be informed about the study and will receive a written     information according to appendix 1., and a new time with (NA) to get the results for kidney     function and oral information about the study as well as their acceptation to be connected to     the study, those patients will receive a standard recommendation to be discharged from     hospital on the day of their operation and they will restart their normal activities the day     after the operation unless there are preventing factors. All patients will be thoroughly     informed by the examiner how to complete the questionnaire and will come through different     tests according to appendix 2., a blood test will be taken according to appendix 12.      All patients should have a CT-scanning of abdomen, chest X-ray and kidney function test     before the operations.      Statistic The number of patients, have been decided to be included to each study, is based on     the realized number of nephrectomy operations that can be done during the specified period     within each department and not on the statistic power of study.      The Scheffé's test will be used for multiple comparisons. The correlation between variables     will be evaluated by using the Spearman's rank correlation coefficient. P values less than     0.05 is considered significant. Statistical analyses will be performed by SPSS statistic     program software.      Publications The results of each study, irrespective of whether these are positive or     negative, will be published in international scientific journals and will be distributed at     relative conferences. The published articles will have Azawi NH as first author, Christensen     T as last author and co-authors according to Vancouver rules.      Ethics The study will be reported to the Danish National Committee on Biomedical Research     Ethics and regionsjaelland paraplygodtkendelsen data control, Ph.D. student (NA) will apply     for enrollment to the PhD programme at the University of Copenhagen. Consent forms will be     received from all patients and they will receive written information about project. The     project will protect all of the data gathered.   "
128728|NCT01600144|"     Mammographical data collection (raw data) for CAD evaluation by VUCOMp software.   "
128729|NCT01600131|"     Aims and Intervention:      The long-term goal is to implement stroke caregiver programs that involve low-cost     interventions that are sustainable in routine clinical practice. The immediate objective is     to test, using a randomized controlled trial, a problem-solving intervention for stroke     caregivers that can be delivered during the transitional care period (e.g., time which     Veteran is discharged to home) followed by online, in-home sessions. The investigators will     modify the traditional, problem-solving intervention by adding web-based training using     interactive modules, factsheets, and tools on previously developed and nationally available     RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The investigators will also     provide on-line, skills training and application of the problem-solving approach via the     RESCUE messaging center. The immediate, primary aim (#1) is to test the effect of the     intervention on stroke caregivers' depressive symptoms at 11 and 19 weeks after baseline data     collection. Aim #2 is to test the effect of the intervention on stroke caregivers' burden,     positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and     satisfaction with care at 11 and 19 weeks after baseline data collection. Aim #3 is to test     the effect of the intervention on Veterans' outcomes: functional abilities and healthcare     utilization (i.e., unintended hospital bed days of care, number of emergency room visits,     number of unscheduled clinic visits) at 11 and 19 weeks after baseline data collection. Aim     #4 is to determine the budgetary impact for implementing the intervention. Aim #5 is to     determine the facilitators, barriers and best practices for implementing the intervention.      Design and Methods:      The investigators will conduct a two-group randomized controlled trial. The investigators     will enroll 240 stroke caregivers at 8 study sites (North Florida/South Georgia Veterans     Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa,     Michael E. Debakey VAMC in Houston, Hunter Holmes McGuire VAMC in Richmond, Central Arkansas     Veterans Healthcare System, VA Tennessee Valley Healthcare System, and the VA Boston     Healthcare System). Eligible caregivers will be interviewed, complete baseline measures, and     then be randomized to two groups: 1) intervention group, or 2) standard care. A team member     will telephone caregivers at 11 weeks and 19 weeks after baseline data collection to answer     questions on instruments with established reliability and validity. Qualitative interviews     will be conducted with selected caregivers to obtain in-depth perceptions of the value,     facilitators, and barriers of the intervention.      Impact:      This is the first known study to test a transition-to-home intervention combined with     technology to improve the quality of caregiving and the recovery of Veterans.   "
128730|NCT01600118|"     This randomized clinical trial investigates the effect of the extracorporeal shockwave     therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically     approved non invasive method to influence bone turnover and tissue regeneration. The     hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically     aligned teeth as well as increase the blood flow. Increasing the periodontal stability would     reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding     tissues.   "
128731|NCT01600105|"     Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis),     with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The     investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI)     techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in     patients with chronic liver disease. These techniques combined could reach high diagnostic     performance for detection of liver fibrosis; and could decrease the number of liver biopsies,     which have risks and sample only a small portion of the liver.   "
128732|NCT01600092|"     A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™     with the existing formulation in infants. The primary hypothesis of the study is that the new     formulation will be noninferior to the existing formulation on the basis of immunogenicity.   "
128733|NCT01600079|"     This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of     herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared     to a cohort of unvaccinated participants.   "
128734|NCT01600066|"     Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies     suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may     reverse erectile dysfunction in affected patients. The present study aims to investigate in a     larger cohort if severe sleep apnea is independently associated with erectile dysfunction and     if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.   "
128735|NCT01600053|"     The purpose of this study is to determine whether on course (6 cycles) of consolidation     therapy with Revlimid can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL) in     the bone marrow.   "
128736|NCT01600040|"     Proton beam radiation therapy is known to spare surrounding normal tissues from radiation.     Proton beam radiation delivers less radiation beyond the area of the target tissues. This may     reduce side effects that patients would normally experience with standard (photon) radiation     therapy which tends to unavoidably include more normal tissue along with tumor target tissue.      In this research study, the investigators are looking to determine if proton beam radiation     is effective in controlling your cancer growth. The investigators are also looking to see if     proton beam radiation can reduce side effects when compared to standard radiation treatment     (photon radiation).   "
128750|NCT01599858|"     The objectives of this study were:      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to     their effect on basal- and food- stimulated gastric pH in healthy volunteers.      To compare repeated doses of YF476 at 2 dose levels, placebo and omeprazole with respect to     their effect on basal and meal stimulated pH.      To assess the safety, tolerability and pharmacokinetics of repeated doses of YF476 in healthy     volunteers.   "
128737|NCT01600027|"     Fractures of the shaft of femur (FSF) are common in children, especially isolated fractures     of the mid-third of the femur which are intensely painful. The pain of the fracture is     thought to originate from the femoral shaft periosteum and muscle spasm from the quadriceps     mechanism. Fascia iliaca compartment block FIC is easy and simple technique, there is no need     for high-skill or expensive equipments. It has higher success rate in more than 90%of the     children thigh procedures.      Potentially dexmedetomidine has become an alternative to clonidine, it is a highly selective     α2 agonist having about an 8-10 times affinity for α2 adrenergic receptors than clonidine and     much less α1 effects, which is responsible for the hypnotic and analgesic effects. Perinural     dexmedetomidine in combination with bupivacaine or ropivacaine enhance sensory and motor     block without neurotoxicity in experimental studies.It has been reported to improve the     quality of intrathecal, Epidural, and caudal anesthesia in children. Also, it is safe and     effective in IV regional anesthetic and axillary block in adult. No study-up to the date -has     been carried to evaluate its effect on the character of fascia iliaca compartment blocks as     adjuvant to bupivacaine. The objectives of this study were designed to detect the effects of     addition dexmedetomidine (Precedex- Abbot) as adjuvant to bupivacaine for fascia iliaca block     on the quality of postoperative analgesia and also to determine its effects on the     hemodynamics, recovery behaviors, sedation and possible side effects in children undergoing     thigh surgeries (fracture femur).   "
128738|NCT01600014|"     The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in     treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in     a previously cleared field.   "
128739|NCT01600001|"     The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic     Idiopathic Constipation (CIC) patients.   "
128740|NCT01599988|"     The Clinical Research Ethics Committee, Cork comprises of faculty representatives, external     representatives, legal representatives and appropriate individuals and ex-officio     administrative members with needed expertise. Ethics Committee members, including the Chair,     are appointed by the Head of College, University College Cork, Medical School.      The Ethics Committee meets once a month.   "
128741|NCT01599975|"     This study is being done to see if a drug called long acting methylphenidate (Concerta) is     safe and effective as a treatment for problems with mental function in adults infected with     HIV.      A subset of patients with HIV-associated memory loss have a defect in the speed with which     they learn and process information. Methylphenidate drugs, such as Ritalin or Concerta, have     been shown on tests to improve the ability to rapidly absorb information; these tests are     called reaction time tests. These drugs are already FDA-approved to treat Attention Deficit     Disorders: ADD or ADHD.      At baseline, all subjects get tests of memory and brain function; then they are split into     two groups. One group on this study will receive Concerta for 2 weeks, and a second group     will receive a placebo x 2 weeks. After that period both groups will receive memory and other     tests of brain function, and then the groups will switch. The first group will receive     placebo and the second will receive Concerta x 2 weeks, followed by more memory and     neurological tests. After that all subjects will have the option to receive Concerta for free     for 8 more weeks. At the last visit all subjects get memory and brain tests again.   "
128742|NCT01599962|"     To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in     healthy humans.   "
128743|NCT01599949|"     The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients     with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy     regimen and who progressed after bortezomib therapy.   "
128744|NCT01599936|"     There is no FDA approved therapy for the treatment of scorpion envenomation. Centruroides     scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging     from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical     syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of     intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms     early in the clinical course while avoiding the clinical deterioration that can occur en     route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than     the present standard of care, midazolam, and faster-acting thus eliminating the need to     transport most rural patients and reducing hospitalization time.   "
128745|NCT01599923|"     There is no FDA approved therapy for the treatment of scorpion envenomation in the United     States. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a     spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides     scorpions develop a clinical syndrome which may require sedation with benzodiazepines and     observation for 6 to 28 hours of intensive care monitoring. A safe therapy is necessary to     halt the progression of symptoms early in the clinical course while avoiding the clinical     deterioration that can occur en route to a tertiary facility. Alacramyn® is anticipated to be     safer and more effective than the present standard of care in the United States, midazolam,     and faster-acting thus eliminating the need to transport most rural patients and reducing     hospitalization time.   "
128746|NCT01599910|"     This study will evaluate the effect of scribes on an academic emergency department.   "
128747|NCT01599897|"     The purpose of this study is to determine the safety, tolerability, and immunogenicity in     healthy adult subjects of an investigational vaccine being developed for the prevention of     pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant     four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with the adjuvant     GLA-SE.   "
128748|NCT01599884|"     N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is     widely prescribed for patients with chronic obstructive pulmonary disease (COPD),     particularly for those who have accompanying symptoms of chronic cough and sputum production.     Randomized, placebo controlled indicate that it is safe and that it may have some clinical     benefit when used at relatively low doses. It is postulated that substantially higher doses     of NAC will be well-tolerated and will provide better symptom control while also decreasing     blood makers of oxidant stress and inflammation.   "
128751|NCT01599845|"     Investigation of the differences between the levels of extracellular and intracellular     nano-particles in workers exposed to environmental particles during their employment to     enhance understanding the process of penetration of the particles to respiratory epithelial     cells.   "
128755|NCT01599793|"     This study is being done to help researchers understand more about prostate cancer that has     spread to the bones by using the newest magnetic resonance imaging (MRI) techniques and to     better understand the effect of an experimental drug called XL184 (or cabozantinib) on bone     disease. The other purposes of the study are to better understand the effect of XL184 on     prostate cancer progression, bone pain, and on any cancer cells that patients may have     circulating within the blood (called circulating tumor cells)   "
128756|NCT01599780|"     This research investigates the ways in which preterm birth affects how very young children     learn to speak and understand language, and how older children gain efficiency in language     processing. The investigators observe how children at different ages learn new words and     comprehend familiar words, how they communicate effectively with others, and how they use     both linguistic and non-linguistic skills in problem-solving. All of the activities in the     investigators' studies are designed to be age-appropriate and fun for children.   "
128757|NCT01599767|"     The purpose of this study is to see the effects of transcranial direct current stimulation     (tDCS) on the pain associated with spinal cord injury. This study is part of the     Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease     in pain levels with active stimulation, when compared to sham stimulation, using a 3 week     stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of     stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have     follow ups at 2, 4 and 8 weeks after the second course of stimulation.      If a subject receives sham during the experiment, he/she may enroll in an open-label portion     of the study and receive 10 days of active stimulation.   "
128758|NCT01599754|"     The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or     delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high     risk patients.   "
128759|NCT01599741|"     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose     significantly. This is realized by anatomy-specific optimization of the full acquisition     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing     engine) for every clinical task individually. Furthermore, smaller focal spot sizes, shorter     pulses and the introduction of automatic real-time motion compensation in subtraction imaging     are used, which are known to positively influence image quality . The final effect on the     clinical image quality in peripheral angiography is investigated in this study.   "
128760|NCT01599728|"     Despite modern advances in treatment, heart failure continues to carry a poor prognosis with     high morbidity and mortality rates. Hence, there remains a major interest in the development     of novel therapeutic agents for this debilitating condition. Urocortins have recently shot     into limelight with their potential role in the pathophysiology and treatment of heart     failure.      Recent studies by the investigators group (REC no: 09/S1103/41) have confirmed that Urocortin     2 and 3 are potent arterial vasodilators, the effects of which are reproducible and well     tolerated in healthy male volunteers. Previous studies using heart failure models in     animals1-7, as well studies in heart failure patients (Urocortin 2), suggest that there is     great scope for Urocortins as novel biomarkers and as potential therapeutic agents in heart     failure. With this in mind, the investigators wish to study the local vasomotor effects of     these peptides in greater detail in patients with heart failure.   "
128761|NCT01599715|"     More than one in three US women suffers from the distressing, embarrassing, and often     unreported problem of urinary incontinence (UI). UI severity increases with age and the     financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of     the 2008 International Consultation on Incontinence concluded that pelvic floor muscle     training (PFMT) should be offered as first line therapy to all women with stress, urge, or     mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative     strategies are low risk and differ from other forms of UI management in that they do not     prejudice future treatments. They also may decrease symptoms of urgency and frequency that do     not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.   "
128762|NCT01599702|"     The study is a prospective, non-controlled, open-label multi-centre pilot safety study of     iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory     Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two     treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will     receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion,     whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV     iron isomaltoside 1000 divided into two administrations.   "
128763|NCT01599689|"     This pilot cluster-randomised controlled trial aims to determine whether the use of bedside     mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium     and improve outcomes in the older cardiac surgical patient.   "
128764|NCT01599676|"     The aim of this study is to assess the effect of citrulline supplementation on muscle     strength in elderly institutionalized subjects undergoing a resistance exercise training     program. The primary endpoint is the outcome of maximum strength of knee extensor muscles.   "
128765|NCT01599663|"     The purpose of this study is to evaluate the effect of an algorithm, where ICU patients pain     are assessed systematically with valid pain assessment tools and where pain is treated after     pain intensity score.   "
128766|NCT01599650|"     This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing     administered with or without adjunctive laser treatment versus laser photocoagulation (the     current standard of care) up to Month 6 in patients with visual impairment due to ME     secondary to BRVO. Additionally the results of this study will provide long-term (24-month)     safety and efficacy data for ranibizumab, administered with or without adjunctive laser     treatment in this indication.   "
128767|NCT01599637|"     The study is designed to explore the mode of action for omalizumab therapy in patients with     chronic idiopathic urticaria.   "
128788|NCT01599364|"     The purpose of this study is to evaluate the virological efficacy of maintenance therapy with     atazanavir with ritonavir combined with lamivudine in treatment experienced HIV positive     patients with full and stable virological suppression.   "
128768|NCT01599624|"     The Stress Resilience Training System (SRTS) program is a stress reduction and resilience     building system that blends cognitive training to anticipate the effects of stress with     advanced biofeedback to mitigate stress effects and aftereffects, using a game-based learning     framework on an iPad platform.      The proposed study will evaluate the effectiveness of the SRTS program at reducing perceived     stress, PTSD symptoms, depression, anxiety, sleep quality, coping, attrition and     class/operational performance among United States Navy service members.   "
128769|NCT01599611|"     The objective of this study was to investigate whether infants with total serum bilirubin >     450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin     encephalopathy develop long term sequelae with impairment of motor development, hearing and     executive function compared with a control group.   "
128770|NCT01599598|"     Military operations and training situations present many physical and psychological     challenges for service members to adapt to and overcome. The challenges of these changing     conditions necessitate having to cope with stress, which is seen as the negative perceptions,     feelings, and emotions that manifest from the subjective physical and/or mental strain on     life processes. In addition, service members are returning from deployments having gone     through traumatic experiences that can develop into posttraumatic stress disorder (PTSD),     depression or other serious conditions. The Surface Warfare Independent Duty Corpsman (IDC)     School is an example of a training environment where some students may be entering the     program with symptoms of PTSD, which may preclude or make it more difficult for them to     perform well. Autonomic nervous system (ANS) dysregulation has been observed in patients with     PTSD and those experiencing chronic stress, such that there is more arousing, sympathetic     input to the heart than calming, parasympathetic input, which is usually the dominant     division of the ANS involved in controlling one's heart rate. The IDC training program is an     example of an environment where the service member is expected to excel while being subjected     to multiple sources of stress. The fast tempo coupled with performance expectations may     induce stress and actually inhibit learning. The Institute of HeartMath has developed the     Coherence Advantage program which teaches one to self-regulate their emotions while focusing     on breathing to compliment the active process of self-regulation. In conjunction, the emWave     Personal Stress Reliever allows the user to receive heart rate variability (HRV) biofeedback,     hence giving the user the opportunity to self-regulate their ANS through breathing and     self-regulation techniques. The proposed study will test the effectiveness of the Coherence     Advantage program versus progressive muscle relaxation (PMR) in reducing stress     symptomatology among Surface Warfare IDC students. The effectiveness of these two different     interventions will be compared on outcomes of PTSD, depression, anxiety, sleep quality,     perceived stress, attrition, and class performance.   "
128771|NCT01599585|"     This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment     for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major     and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA     delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and     depression as in-person BA treatment for depression.   "
128772|NCT01599572|"     Background: Zinc supplementation has the potential to improve serum zinc levels and immunity     of zinc deficient nursing home elderly.      Objective: To determine the effect of zinc supplementation of 30mg/d for 3 months on serum     zinc levels and T-cell mediated function of zinc deficient nursing home elderly.      Design: This is a randomized, double-blind, placebo-controlled study. Outcome measures     included change in serum zinc levels and various T-cell mediated immune factors between     baseline and month 3.      Hypotheses: The investigators hypothesize that zinc supplementation of 30mg/d for 3 months     will improve serum zinc levels as well as various T-cell mediated immune factors in zinc     deficient nursing home elderly.   "
128773|NCT01599559|"     Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and     the monoclonal antibody rituximab (chemoimmunotherapy).      Following chemoimmunotherapy patients receive radiation therapy if they have residues which     may be active tumour. However at the end of chemoimmunotherapy the majority of patients show     tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to     be a good tool to accurately identify active tumor from scar tissue in patients treated for     mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really     necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we     will compare radiation treatment with careful observation.      Patients that at the end of conventional treatment of chemoimmunotherapy have a negative     PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to     two different treatment groups: one treatment group will receive the radiation treatment, and     the other treatment group will receive careful observation.      The trial is planned according to a non-inferiority design aimed at demonstrating that     progression free survival after the experimental treatment (observation) is not worse than     after the standard comparator (mediastinal irradiation.Participation in this study could     spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative)     radiation therapy that may be unnecessary.   "
128774|NCT01599546|"     The purpose of this study is to understand reading abilities of children born preterm: their     cognitive profiles, the neural basis of good and poor reading abilities, and the behavioral     and neural factors that predict persistent difficulties. The investigators hope to learn        -  what specific skills correlate reading skills        -  if preterm children have different cognitive profiles than full term children with          respect to reading        -  if cognitive skills measured in kindergarten predict reading ability in the second grade        -  if parts of the brain are associated with reading skill        -  whether brain characteristics in kindergarten predict reading in second grade.   "
128775|NCT01599533|"     Many publications deal with the natural history of aortic aneurysms in literature. Except for     connective tissue disorders as Marfan or Loeys-Dietz syndrome, aortic aneurysms are a complex     multifactorial disease with genetic and environmental risk factors. Susceptibility loci     identified in thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA) do not     overlap, suggesting that different genetic risk factors contribute to these two forms of     aneuryms. With a higher prevalence correlated to ageing (5%), AAA is usually presented as the     degenerative form of the disease. However, a recent epidemiologic study by Olsson et al. has     revealed an increasing incidence of thoracic aortic disease among older individuals (70+/-12     years) with 60% of aneurysmal rupture or dissection at diagnosis, and a 1.7 :1 male-to-female     ratio compared to 6:1 in AAA. From this current knowledge arises the concept of diffuse or     plurisegmental degenerative aneurysmal aortic disease, poorly explored so far. As regards to     the prevention policy, there is a consensus statement in which ultrasonography screening for     AAA is recommended for all individuals aged > 60 years (particularly in men who have ever     smoked) and for those aged > 50 years with family history of AAA. Nevertheless, screening for     a concomittant thoracic location of the disease (except thoracoabdominal aneurysm) is not yet     required, whereas it could change the prognosis of the patients and influence their     management.   "
128776|NCT01599520|"     Cancer patients receiving chemotherapy experience a number of aversive symptoms that are     accompanied by declines in physical and mental well-being. Although the benefits of stress     management training interventions on quality of life are well documented, there are no     published studies examining the efficacy of these interventions among Hispanic women and     Latinas (hereafter referred to as Latinas) receiving chemotherapy. This dearth of research     reflects the general lack of stress management interventions for cancer patients whose     preferred language is Spanish. Simply translating existing English-language interventions     into Spanish may seem to be a solution for the lack of Spanish-language stress management     interventions. This approach, however, does not take into account cultural values, beliefs     and situational realities that are likely to contribute to patients' uptake of health     promoting behaviors. The proposed research seeks to address this gap by evaluating a stress     management training intervention developed specifically for Latinas beginning chemotherapy     for cancer.      In response to the identified need, the investigators created a Spanish-Language     Self-Administered Stress Management Training (SL-SAT) intervention Cómo tratar el estrés     durante la quimioterapia (How to manage stress during chemotherapy). The intervention is     based on an English-language self-administered stress management training intervention the     investigators previously developed and showed to be efficacious in a randomized controlled     trial. Development of the Spanish-language intervention was the result of extensive use of     ethnographic and learner verification methods, guided by a community-based participatory     research approach. Similar to the English-language version, the SL-SAT intervention consists     of a digital video disc(DVD), booklet, and audio compact disc (CD), and provides instruction     in three well-established stress management techniques: deep breathing; progressive muscle     relaxation and guided imagery; and use of coping self-statements. The proposed study will     evaluate the efficacy of this transcreated intervention in a randomized controlled trial     involving Spanish-speaking Latinas about to begin chemotherapy for cancer. Following a     baseline assessment, participants will receive usual care or usual care plus the SL-SAT     intervention. Participants will be reassessed on study measures approximately 7 and 13 weeks     after the baseline assessment.   "
128777|NCT01599507|"     The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the     correction of anemia in non-dialysis chronic kidney disease patients.   "
128778|NCT01599494|"     This study, conducted in India, will be recruiting women participants who are between the     ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but     have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection     (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell)     production after administration of the investigative drug, MK-8962 (corifollitropin alfa) +     recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference     drug, recFSH.   "
128779|NCT01599481|"     The aim of the investigation is to evaluate the effectiveness and costeffectiveness of a     model of supported employment (the Individual Career Management (ICM) model) designed to help     people with common mental illness return to work.   "
128780|NCT01599468|"     The purpose of this study was to evaluate the effect of early administration of tranexamic     acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.      This was a randomised, placebo controlled trial including 74 patients. The investigators     included ASA1 parturients with correct haemostatic status undergoing cesarean section under     spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and     starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg     of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the     2 following hours. Placebo Group received same volumes of normal saline. The investigators     compared blood loss and transfusions in both groups.   "
128781|NCT01599455|"     Following spinal cord injury (SCI), the body loses normal control of blood pressure and heart     rate, and there is a risk of sudden and dangerous increases in blood pressure, namely,     autonomic dysreflexia (AD). It is important to be aware of baseline blood pressures and heart     rates in individuals in order to detect AD. However, baseline values vary in developing     children, and may be more variable in children with SCI. Thus, the objective of this study is     to determine baseline blood pressure and heart rate measurements in children with SCI during     rest and during urodynamic testing.      The investigators hypothesize that 1) blood pressures will increase with increasing age and     body mass index; 2) heart rate will decrease with increasing age; 3) blood pressures will     increase with increase in bladder filling; 4) blood pressures will increase will increase     with increasing duration of injury.   "
128782|NCT01599442|"     Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous     system), vascular, mechanic and metabolic factors, which are further complicated by an     impairment of the immune system and a corresponding increase in the risk for infections.     Results from clinical trials about the efficacy of interventions aimed at reducing the number     of patient-relevant end points are of limited comparability due to the heterogenity of     patient characteristics. By their very nature, randomized clinical trials (RCT) can only     focus on a limited section of the wide range of possible intervention regimes. In clinical     practice, however, a number of patients with dfs will never have been part of a clinical     trial. Furthermore, there are only very few contemporary registers for this indication from     which conclusions with regard to the comparative merits of different therapeutic strategies     may be drawn.      The register was conceived to find out to which extent RCT patients are representative for     the overall patient collective with dfs and critical limb ischemia and to evaluate the     therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase     versus placebo is imbedded in the register.   "
128783|NCT01599429|"     Positron emission tomography uses various radioactive tracers to measure the metabolic     activity in a none-invasive way, and specially to follow the activity of the disease during     the treatments.      Among those new tracers, fluorothymidine (18F-FLT) arouses a lot of interest. This new tool     would allow to image and follow time wise acute myeloid leukemia (AML). The investigators     want, with the (18F-FLT), to characterise the aggressivity of the tumors and the prognostic     before and after chemotherapy treatment.      The aim of this study is to be able to identify earlier the responders, because if they are     detected sooner, these patients will benefit from more aggressive treatments.   "
128784|NCT01599416|"     The purpose of this study is to understand the effect of using oral U-relax on HPV infected     women for vaginal environment health promotion, and the HPV DNA Test Index change from     positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax     contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on     treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive     result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of     cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and     patients with HPV DNA test positive result.   "
128785|NCT01599403|"     The primary objective of this study is to investigate whether continuous PVB is equal in     efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or     is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs     equal to or greater than 1.2.   "
128789|NCT01599351|"     The objective of this study is to evaluate the radiation dose to patient at two positions     (prone and left lateral) and to medical staff during Endoscopic retrograde     cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and     thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and 20     patients at left lateral position.   "
128790|NCT01599338|"     Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1     analogues decrease satiety and food intake leading to a significant weight loss in patients.     However, little is known about their effects on food hedonic sensations and taste perception.      The aim of this study is to investigate the impact of Liraglutide on the liking and wanting     components of the food reward system, taste sensitivity and sensory specific satiety in type     2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models,     it is expected that Liraglutide will modify food preference and gustative perception in     humans.      Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide     (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the     treatment administration. Olfactory liking, recalled liking and wanting for several food     items will be assessed. Sensory specific satiety will be measured as well as detection     thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on     hunger, pleasure in eating, and food intake.   "
128791|NCT01599325|"     The purpose of the study is to determine whether azacitidine is safe and effective in the     treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).   "
128792|NCT01599312|"     In this randomized crossover trial the investigators test whether three different brands of     videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare     them with a classic Macintosh laryngoscope blade.   "
128793|NCT01599299|"     The purpose of this study is to determine whether there is a difference between the diameter,     and the cross-sectional area of the right internal in left internal jugular vein in     preoperative, mechanically ventilated patients.      Secondary the relationship between the internal jugular vein to the common carotid artery     will be examined.   "
128794|NCT01599286|"     The overall objective of this drug trial is to determine whether treatment of acute     hyperammonemia with N-carbamyl-L-glutamate (NCG, Carglumic acid, NCG) in propionic acidemia     (PA), methylmalonic acidemia (MMA), late-onset CPS1 deficiency (CPSD) and late-onset     Ornithine transcarbamylase deficiency (OTCD) accelerates the resolution of hyperammonemia     efficiently and safely.      The primary goal is to determine if the study drug (NCG) efficiently reduces ammonia levels     following a hyperammonemia episode(s).      Secondly, the investigators want to know if treatment with this study drug (NCG) efficiently     improves neurologic function, reduces plasma glutamine levels and lessens the duration of     hospitalization after each hyperammonemic episode.   "
128795|NCT01599273|"     Thyroid-associated ophthalmopathy (TAO) is an autoimmune process that can affect the orbital     and periorbital tissues and the thyroid gland. Periorbital inflammation can cause swelling,     fatty infiltration, and scarring of the eyelid muscles resulting in eyelid retraction and     upper scleral exposure, which is the most common clinical features of TAO.Even with mild     eyelid retraction and swelling, most patients become disappointed and depressed due to their     cosmetically unacceptable appearance, and they are unwilling to wait for spontaneous     resolution or a clinically inactive period for surgical intervention. Thus, most     ophthalmologists and endocrinologists recommend surgery in the chronic burnt-out stage.     Several treatment options have been described for correction of eyelid retraction, including     Botox and filler injection, and surgeries in the burnt-out stage such as lowering the upper     lid by recessing the levator muscle, excision of Müller's muscle, introducing a spacer, or     myotomies.Surgical options have significant risks as well as an unpredictable course and     outcome in some cases. Several authors have reported that subconjunctival botulinum toxin     injection provides an immediate, effective treatment by reducing excessive levator function     in patients who suffer from disfiguring eyelid appearance and do not want to wait for surgery     for upper eyelid retraction.Botox treatment is usually temporary. However, unwanted ptosis,     although temporary, was observed in five out of 24 patients (20.8%) in the study by Costa,     which may be even more disappointing and cosmetically unacceptable to some patients.Recently,     hyaluronic acid gel fillers, which were injected into the subconjunctival levator-Muller     plane, demonstrated efficacy in managing Graves' eyelid retraction in three patients.However,     complications such as a lumps, fluid buildup, and skin pigment darkening may occur using this     technique.Steroid treatment represents a well-established TAO management strategy due to its     anti-inflammatory and immunosuppressive actions. However, multiple systemic side effects such     as diabetes, infection, hypertension, osteoporosis, and stomach ulcers are major drawbacks of     systemic steroid treatment. Due to limitations of systemic steroid treatment, several studies     reported TAO improvement with periorbital injections of methylprednisolone and triamcinolone,     primarily focusing on reducing proptosis and diplopia. So far, however, only a single small     case series study has suggested that an injection of 20 mg triamcinolone into the     subconjunctival region of the lid, between the conjunctiva and Muller's muscle, improves     upper eyelid retraction within 1 month in three of the four patients. The investigators are     not aware of any study designed to demonstrate the treatment efficacy of locally administered     triamcinolone to improve eyelid retraction and swelling in a prospective manner. Therefore,     we aimed to evaluate both the short-term and long-term effects of subconjunctival     triamcinolone injections in treating eyelid retraction and inflammatory swelling caused by     TAO.   "
128796|NCT01599260|"     People with rheumatic disease often have decreased strength, muscle mass, and bone mineral     density due to repeated bouts of inflammation, normal effects of aging, disuse, and     inactivity. The medications used to quell the disease process, such as prednisone, can also     have detrimental effects on body composition, strength, and functional capacity. The     investigators propose to investigate the feasibility, safety, and effects of resistance     exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique     resistance protocol the investigators propose involves performing movements in a slow and     controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of     the resistance) to minimize force on the joints and connective tissues. This will be     conducted in an individually-supervised environment with a new generation of exercise     equipment that will accommodate their musculoskeletal capabilities and allow for     reproducibility of the exercise protocol. The investigators intend to investigate the     feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise     protocol in older patients with rheumatoid arthritis and vasculitis by testing their     strength, body composition, functional ability, mood, and quality of life before and after     this 16-week resistance exercise intervention.   "
128797|NCT01599247|"     Specific aim #1: To assess the study team's ability to recruit subjects in this cohort and to     successfully complete follow-up assessments by phone or mail.      Hypothesis: Over 50% of eligible subjects will enroll in the observational study, and 70% of     follow-up assessments will be successfully completed.      Specific aim #2: To determine the natural history of hopelessness, ongoing suicidal thoughts,     and optimism in subjects at 2, 4 and 8 weeks after discharge.      Hypothesis: Subjects will continue to have moderate levels of hopelessness, suicidal     thoughts, and optimism at follow-up assessments.   "
128798|NCT01599234|"     The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of     spasticity in multiple sclerosis   "
128799|NCT01599221|"     This is an observational, retrospective and prospective study where subjects who have     undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be     followed for data collection since the day before their surgery (retrospectively) until day     180 after surgery (retrospectively and prospectively).      This study is aimed at collecting data from patients who have already been treated with EBA2     nail. Data collection will cover the details of the fracture and surgery (from which the     retrospective nature of the study), as well as details of follow up visits after surgery that     patients routinely carry out up to 6 months (from which the prospective nature of the study).      The study will be conducted in three clinical sites in Italy.   "
128800|NCT01599208|"     The goal of the proposed research is to map the effects—in particular facilitation—of     Transcranial Magnetic Stimulation (TMS) of the Medial Temporal Lobes (MTL) onto the     processing of associative memory. TMS technology has the potential to selectively enhance     functions mediated by areas in the temporal cortex, including the MTL, known to be the     primary neuronal seat of episodic memory. By using this technology the investigators can     further our understanding of theoretical models of human memory (specifically regarding the     role of Recollection and Familiarity processes), and additionally, provide a possible route     to the recovery of some of memory loss typically observed in the elderly—namely, memory for     associations. Given the MTL's critical role in human memory and facilitation-inducing     qualities of TMS, this research goal is to provide a nonintrusive tool to facilitate memory     performance in young and elderly healthy participants.   "
128801|NCT01599195|"     The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the     presence of bruit by using an acoustic signal to represent the bruit. This pilot study will     address two questions: is there a detectable difference in recorded sound signal of carotid     and femoral bruit when compared to sound signals captured when there is no bruit present; is     the use of a visual recorded signal more accurate in identifying carotid and femoral bruit     when compared to traditional auscultation with a regular stethoscope and ultrasound.   "
128802|NCT01599182|"     This study will work towards understanding the changes in your body (metabolism) that develop     with treatment in prostate cancer. Hormonal therapies such as ADT often result in detrimental     changes in body composition, including lean tissue loss and fat gains, compared to those     patients receiving radiation therapy. These changes in body composition are linked to risk of     diabetes and cardiovascular disease in survivorship. The investigators will be evaluating 50     patients to primarily examine the changes in metabolism, nutrition, physical function and     body composition at the end of treatment, 6 weeks and 6 months following the end of     treatment. Patients will continue to be followed every 6 months for up to 5 years following     the end of treatment. The investigators findings will provide a new perspective for future     work and novel approaches in the treatment of prostate cancer.   "
128803|NCT01599169|"     The purpose of this study is to determine the efficacy and the tolerance of the food     supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and     Extramel®, on the burnout syndrome.   "
128804|NCT01599156|"     The purpose of this study is to examine if the use of reflexology can alleviate chronic     constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks     of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18     years of age or older, which are able to comply with the study guidelines; Fewer than three     spontaneous bowel movement per week; and one or more of the following symptoms/signs during     more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1)     straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion     criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel     movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on     the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for     the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies;     Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.   "
128805|NCT01599143|"     Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon     Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to     conventional treatment for patients suffering from many diverse chronic ailments. Three     decades of research have documented it's benefits, but few papers have focused on identifying     which particular aspect of MBSR directly correlates with it's degree of therapeutic efficacy.     This study will use 7 well validated questionnaires to compare participants responses prior     to, and following completion of an eight-week MBSR program at the North York General     Hospital, as well as follow-up results at 1 month and 1 year post completion of the MBSR     group.   "
128806|NCT01599130|"     For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but     without HBeAg loss, switching to peg-interferon may increase the response rate. In the     investigators study, patients were divided into two groups. In Group A, patients continued     entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a     monotherapy for 48 weeks, then followed up 24 weeks.   "
128807|NCT01599117|"     The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5     inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with     heart failure with preserved ejection fraction (HFpEF).   "
128808|NCT01599104|"     This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension   "
128809|NCT01599091|"     Porphyromonas gingivalis is one of the major bacteria involved in the formation and     progression of chronic periodontitis. Pathogens invading the gingiva face the host's innate     immune system at first and later on the acquired immune system which includes secreted     antibodies and specialized cells. Although both the arms of the immune system are coordinated     to overcome the infection, there are several known mechanisms which help pathogens as     Porphyromonas gingivalis evade immunity. As a result, inflammatory mediators secreted by     immune cells cause tissue damage and lead the inflammation process towards chronicity instead     of clearing the pathogen. Up till recently most of the studies focused on the role of     macrophages, dendritic cells and lymphocytes at the response to periodontal pathogenic     bacteria while the role of fibroblasts (the most abundant cell in the connective tissue) was     less examined. Fibroblasts are spindle shaped cells which have the ability to produce extra     cellular matrix and respond to growth factors and cytokines. They are able to affect cells in     the infected tissue and contribute to immune response efficiency. As known in the case of     lymphocytes, fibroblasts also vary in subtypes, each differs in phenotype, immune     interactions, extra cellular matrix production and destruction, migration abilities and so     on. Two main fibroblasts subtypes in the oral cavity originate in the gingival tissue and the     periodontal ligament anchoring teeth to the surrounding alveolar bone. Amongst the     differences between the two are collagen production ability and receptors profile over the     cell surface. Considering all that, the investigators aim to obtain and use periodontal     ligament and gingival tissues removed anyways during common dental procedures in order to     extract the different fibroblasts subtypes residing there and compare their response to     Porphyromonas gingivalis.   "
128810|NCT01599078|"     The purpose of this study is to assess the safety and efficacy of administering     intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following     percutaneous revascularization to prevent restenosis.   "
128811|NCT01599065|"     The purpose of this study is to compare the two options for management of ICDs (internal     cardioverter defibrillators) in patients undergoing procedures with electrocautery: (1)     programming ICD therapies off, or (2) use of a magnet to suspend ICD therapies By comparing     these two techniques the investigators hope to demonstrate the efficiency of using an ICD     magnet protocol during perioperative management of patients undergoing electrocautery     procedures. Secondary purposes are to gain further information on health care resources,     incidence of EMI, handoff communications and to document lack of adverse events in either     group.      Primary objective will be: ICD therapy off times will be less with the use of a magnet     protocol compared to an off-on protocol. Secondary objectives will be: (1) Healthcare     resources (time and costs of skilled personnel) will be less using a magnet protocol compared     to an off-on protocol, and (2) there will be no difference between adverse events in the     magnet protocol compared to an off-on protocol. The incidence of EMI and number of handoff     communications will be documented.      The investigators hypothesis is that the number of minutes with ICD therapies off will be     significantly less with magnet use. The investigators also expect health care resources to be     less with magnet use compared to reprogramming.   "
128812|NCT01599052|"     There is ample evidence that children treated for a brain tumour (BT) often develop deficits     in social and emotional functioning. The investigators wish to examine the cause of these     deficits, i.e. the underlying neuropsychological deficit(s). The aim is to study impairment     and developmental delay in social cognition (and related cognitive functions) caused by brain     damage in patients treated for a BT in childhood as compared to a reference group of     chronically ill children. If we can identify the specific deficits these patients experience,     neuropsychological treatment and guidance can be developed to give patients the most optimal     chances to live as normal as possible, to improve their quality of life (QoL) and to prevent     them from developing depression and anxiety. Eventually, an intervention programme could be     developed based on our results, to improve social, vocational and emotional QoL.   "
128813|NCT01599039|"     The goal of the study is to investigate the use of bio-impedance spectroscopy in the     assessment of breast cancer related lymphoedema in patients operated with lumpectomy or     mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water     volumetry. As a control group, patients with colon rectal cancer are used to compare     volumetric and spectometric changes during follow-up.   "
128814|NCT01599026|"     Good glycemic control is superior to poor glycemic control in reducing risk of     interventricular septum thickness among fetuses of diabetic mothers   "
128815|NCT01599013|"     This study is assessing the combination of well known cytotoxics with a novel anti-cancer     agent that could be administered as monotherapy without renal toxicity in patients with renal     impairment presenting with advanced or metastatic urothelial carcinoma previously treated     with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio     of the two most promising associations of cytotoxics including the novel therapeutic agent,     vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.   "
128816|NCT01599000|"     In 2009, Papua New Guinea officially adopted artemether-lumefantrine (AL) as new national     first-line drug for uncomplicated malaria. The principal purpose of this study is to measure     the absolute effectiveness of AL when used under real-life clinical conditions, as compared     to optimized in-vivo trial conditions. This question was raised by the National Department of     Health in preparation for the country-wide roll-out of AL.      The study is designed as a randomized controlled trial comparing two study arms. Patients in     the effectiveness arm receive the first dose of AL under full supervision in the clinic;     the following doses will be taken at home, as in real-life clinical practice and according to     the new national treatment guidelines. Patients in the efficacy arm will receive all doses     of AL as directly observed treatment in the clinic in order to establish the efficacy of the     drug when used under ideal conditions.      The study will enroll outpatients aged 6 months to 10 years with a history of fever and a     positive rapid test for malaria. Patients meeting all enrollment criteria and providing full     written informed consent by a parent/caretaker will be randomized into either of the two     study arms. Patients in both arms will be followed up actively for 42 days. Patients in the     efficacy arm will be scheduled for visits on days 0, 1, 2, 3, 7, 14, 28 and 42; patients in     the effectiveness arm on days 0, 3, 7, 14, 28 and 42.   "
128817|NCT01598987|"     This study was designed to assess the evolution of renal function and to collect efficacy,     safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric     liver transplant recipients.   "
128818|NCT01598974|"     Acupuncture has been used for many years to help relieve pain. However, it is not clear how     acupuncture works. We are doing this study to learn about the effects of different forms of     acupuncture on chronic low back pain. We are interested in learning about brain activity     during pain. We plan to look at brain activity at the beginning and the end of the study,     after 6 sessions of acupuncture.   "
128819|NCT01598961|"     There have been reports of monitoring LSR during MVD surgery helps predicting the clinical     outcome of MVD.However, there have been no evidence of which degree of partial neuromuscular     blockade should be performed or no neuromuscular blockade could be performed during LSR     monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of     different degree of partial neuromuscular blockade, including no neuromuscular blockade on     the LSR monitoring for MVD surgery.   "
128820|NCT01598948|"     Elevated LDL-cholesterol is a major risk factor for heart disease. In patients with heart     disease LDL-cholesterol should be lowered to levels below 70 mg/dl to prevent progression of     disease. In most patients life style modification together with lipid lowering drug therapy     is sufficient to achieve this goal. In some patients with severe forms of     hypercholesterolemia, this may not be sufficient to reach goals and regular lipid apheresis     (a costly and time intensive form of therapy) may be performed. Mipomersen is a new drug     (apoB antisense oligonucleotide) that can lower LDL-cholesterol even in the most severe forms     of LDL-hypercholesterolemia by 25-47%. It is unknown whether and to what extent mipomersen     can decrease LDL-cholesterol in patients treated with regular apheresis. Phase 1 of the study     will test how 6 months of weekly therapy with mipomersen affects LDL-cholesterol in patients     with severe LDL-hypercholesterolemia treated with regular apheresis. Phase 2 will test in how     many patients this will result in a meaningful reduction of apheresis time, apheresis     frequency or if apheresis can be stopped completely.   "
128821|NCT01598935|"     Today, there is an important lack of knowledge on the effects of dietary protein on protein     metabolism after physical activity in children. Here, the investigators will measure changes     in whole body protein metabolism using minimally invasive techniques and stable isotope     methodology at rest and after physical activity with the intake of milk protein.   "
128822|NCT01598922|"     The purpose of this study is to understand the effectiveness of a ten-week internet-based     cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and     resilience skills, and cognitive processing.   "
128823|NCT01598909|"     Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the     field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use     Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent     study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical     outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment     postoperatively will reduce the development of ecchymosis and improve outcome.   "
128824|NCT01598896|"     Cannabis use disorders are an important public health problem in the United States, but no     effective pharmacotherapies are available to treat these disorders. People with schizophrenia     are more likely than healthy people to abuse cannabis. Cannabis use may worsen clinical     outcomes in this group, making the identification of pharmacotherapy to treat cannabis     dependence in those with schizophrenia important. The investigators intend to test the     combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist clonidine,     for cannabis dependence in subjects with schizophrenia. The combination of dronabinol and     clonidine may alleviate cannabis withdrawal symptoms while allowing treatment-seeking     outpatients to benefit from medical management (MM) sessions when they are trying to stop     using cannabis. The investigators propose to assess the relationship of dronabinol and     clonidine, when added to MM, on cannabis use patterns in cannabis-dependent patients with     schizophrenia.      Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and     clonidine will significantly reduce cannabis use compared to those receiving placebo.   "
128825|NCT01598883|"     This study will explore altered heparin responsiveness (AHR) in cardiac surgical patients     undergoing cardiopulmonary bypass (CPB) requiring systemic anticoagulation with heparin. The     investigators will evaluate the hypothesis that AHR may be directly related to, modulated or     mediated by interactions between heparin, antithrombin (AT), the heparin-AT complex, and one     or more acute phase proteins. The investigators are particularly interested in identifying     patients with true heparin resistance, that is, patients who demonstrate AHR even after     antithrombin-replenishment in the presence of an adequate systemic dose of heparin.   "
128826|NCT01598870|"     The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial     peritonitis and the decisional thresholds to start treatment. The accuracy of current     diagnostic tests will be compared with that of new tests, which could potentially become more     accurate reference standards. This could lead to the definition of a more accurate and     effective diagnostic algorithm.   "
128827|NCT01598857|"     The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when     taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel     Vasculitis.   "
128828|NCT01598844|"     The purpose of this registry is to observe longterm performance and safety of the JenaValve     TAVI system, in routine medical and everyday conditions.   "
128829|NCT01598831|"     The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis     can decrease mortality.   "
128830|NCT01598818|"     The aim of this study is to test the efficacy of the First-Sight refractive kit designed to     provide refractive correction of simple hyperopia, myopia and astigmatism with     autorefraction.   "
128831|NCT01598805|"     Now, after a cluster randomized controlled trial, eAlerts providing evidence-based guidelines     on venous thromboembolism prophylaxis will be rolled out and evaluated hospital-widely.   "
128832|NCT01598792|"     It is the investigators intention to investigate whether a specially designed vaccine, based     on a genetically modified strain of the bacterium Listeria monocytogenes and called     ADXS11-001 is safe to use and is able to boost the immune system of patients presenting with     Human Papilloma Virus (HPV) associated oropharyngeal cancer (OPSCC). It is hoped that the     vaccine will boost the immune system so that immune cells with cell killing properties are     able to attack any cancer cells remaining after the patients have been treated. However, the     vaccine is so novel the investigators are not sure whether it is able to do this and before     they can answer that question in a larger group of patients they need to make sure that the     vaccine is safe to use and has some effect on the immune system in the patients for whom they     intend its ultimate use. In a previous study, patients with incurable cervix cancer which is     caused by the same virus, were vaccinated with ADXS11-001. Although all patients vaccinated     experienced flu-like symptoms, patients tolerated the vaccine well with no patient suffering     long term adverse effects of vaccination. However, because the patients and cancer type was     so different in this earlier study, the investigators need to test whether ADXS11-001 is also     safe in patients with HPV associated OPSCC. That said, the earlier study guided the dosing     schedule for the current study and patients entering the REALISTIC trial will receive lower     doses than those administered to patients in the earlier cervix cancer study. It is hoped     that by doing this, patients will experience fewer side effects of vaccination without     reducing the chances of stimulating the immune system.   "
128833|NCT01598779|"     The summary of this study is to know which HPV types are present in genital warts in     Argentinean population.   "
128834|NCT01598766|"     This study is a feasibility study to evaluate new technology to improve the MRI experience,     with coils, sequences and software. Patients from the Principle Investigator's exam schedule     are given the opportunity to participate in this study is their MRI exam is appropriate for     the specific coil, sequence or software being evaluated. If they agree, they can receive     their MRI exam with the new coil, sequence or software instead of the standard one.   "
128835|NCT01598753|"     This is a randomized control study that involves a combination of a drug treatment,     behavioral health, and placebo controls.      Some participants will receive a medication approved by the Food and Drug Administration for     treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive     an inactive pill, called a placebo. There will also be 2 different types of behavioral health     treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have     been recommended for the treatment of patients with FM by the American Pain Society.      There are 4 possible study treatment combinations:        1. Tramadol + CBT,        2. Tramadol + HE,        3. Placebo + CBT,        4. Placebo + HE.      Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there     have been no studies that have evaluated the combination of medication and a behavioral     health treatment. The primary purpose of this study is to compare the benefits of the 4     combinations listed.   "
128836|NCT01598740|"     The purpose of this study is to determine the effects of CLP, with and without     spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic     kidney disease.   "
129520|NCT01589796|"     Pain relief after open inguinal hernia repair could be improved by administration of TAP     block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The     investigators hypothesize that doing TAP block closer to the middle of the abdomen would     result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric     nerves.   "
128837|NCT01598727|"     Hypothesis: Intraoperative use of near infrared fluorescent imaging technology and detection     of Methylene Blue fluorescence will improve outcomes following thyroid and parathyroid     surgery.      Aims: The aims of this phase of the study are to determine the feasibility of using near     infrared fluorescent technology in the detection of parathyroid tissue and its     differentiation from adjacent soft tissue during surgery on parathyroid glands.      Objectives of the phase I study:        1. To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device          (Fluoptics).        2. To understand the patterns (onset, intensity and duration) of fluorescent staining of          normal parathyroid glands, thyroid glands and other soft tissue structures encountered          during parathyroidectomy.      Further research:      This will be followed by a phase II study during which fluorescent imaging will be used in     conjunction with intraoperative incremental dose of IV methylene blue in both thyroid and     parathyroid surgery. Phase II will enable us to develop a protocol for the use of a minimum     possible dose of MB for the identification of parathyroid glands. This will then be tested in     the pilot phase of a randomized clinical trial.   "
128838|NCT01598714|"     This study compares patient satisfaction in terms of pain relief, mobility and ease of use     between 3 commonly used types of post-surgical footwear. This study randomises patients who     participate into one of 3 groups of footwear, namely Darco, Podalux or standard dressing     shoe. Number of patients enrolled is determined by power calculation. Patients complete a     single, simple previously validated questionnaire the MOXFQ (Manchester-Oxford Foot     Questionnaire) at their 6 week follow-up appointment and statistical differences between the     group are calculated using a significance level of p<0.05. This study will help us determine     the best foot-wear to offer the investigators post-surgical patients.      This study will form original research.   "
128839|NCT01598701|"     The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an     effective adjunct therapeutic agent in patients undergoing craniotomy.   "
128840|NCT01598688|"     The purpose of this study is to verify whether differences exist in cyclosporine levels     between the samples collected through peripheral venous access, the catheter line used to     infuse the drug and the line not used for infusion immediately after interrupting the drug     infusion or five minutes after the interruption.   "
128841|NCT01598675|"     Many of the 780,000 people affected by stroke each year are left with slow, asymmetric     walking patterns. The proposed project will evaluate the effectiveness of two competing motor     learning approaches to restore symmetric gait for faster, more efficient, and safer walking.   "
128842|NCT01598662|"     This is randomized controlled trial designed for pregnant women who deliver vaginally at the     University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted     for postpartum contraception. After informed consent is obtained, eligible study participants     will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10     minutes of delivery of the placenta following a normal vaginal delivery. The investigators     seek to determine the expulsion rate and complication rate in subjects with IUD immediately     after placental delivery compared to insertion at six weeks postpartum or later. The     investigators hypothesize that immediate placement safe and has an acceptably low expulsion     rate to merit earlier placement in the indigent population.   "
128843|NCT01598649|"     The objective of the study is to elucidate the effects of lupin protein (Lupinus     angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify     the role of arginine, one of the most abundant amino acids in lupin protein.   "
128844|NCT01598636|"     The Lateral Tibial Tunnel technique is a new concept in Anterior Cruciate Ligament (ACL)     surgery. In this technique a tibial tunnel is drilled from the antero-lateral side of the     tibia towards the ACL footprint. This technique allows the surgeon to deal with bone stock     problems in the antero-medial part of the tibia as often encountered in ACL revision surgery.     In ACL revision surgery it is often impossible to perform a one-stage revision surgery     procedure due to bone stock deficiency in the antero-medial side of the tibia. It is     hypothesized that the Lateral tibial tunnel technique allows the surgeon to perform a     one-stage procedure instead of a two stage procedure. Furthermore the lateral tibial tunnel     technique allows better graft fixation in two-stage ACL revision surgery. Several     biomechanical studies proved biomechanical superiority of the new technique compared to the     classical technique.   "
128845|NCT01598623|"     The objectives of the study are:        1. To evaluate the effect of OT compared to placebo, as add-on to anti-psychotics, on          social functioning in schizophrenia.        2. To evaluate the effect of socially oriented CBT administered to patients immediately          after they receive OT, compared to patients who receive OT with not-socially oriented          CBT, and compared to patients who receive socially oriented CBT without OT. The          investigators hypothesize that OT and socially oriented CBT will have a synergistic          effect, and will be better than OT or CBT alone.        3. Use a detailed, in depth analysis of social interaction to assess these putative effects          of OT. The investigators hypothesize that the use of this analysis will show larger          treatment effects of OT than previously shown in less sensitive assessments, such as          PANSS.        4. To assess the effect of epigenetic status on response to OT. The investigators          hypothesize that epigenetic variants associated with lower OT plasma levels will be          associated with greater response to OT treatment.        5. To assess in the relationships between levels of salivary OT and vasopressin, and social          interactions in schizophrenia.        6. To assess in the relationships between levels of salivary OT and vasopressin, and          response to OT treatment.   "
128846|NCT01598610|"     The purpose of this study is to demonstrate that untrained subjects who have diabetes can     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose     results.   "
128874|NCT01598246|"     This is a prospective chart review of all extubations in the pediatric intensive care unit.     Over a one year period all extubations in the unit are to be recorded on a designated form     and standard variables charted and compared. All data will be collected from the chart,     retrospectively after the extubation event. Patients who fail extubation will be compared to     those who succeed. We aim to identify factors which contribute to extubation failures in the     unit, to come up with a unit specific extubation policy   "
128875|NCT01598233|"     The purpose of this study is to evaluate the effects of intragastric balloon on bone,     metabolic and respiratory parameters in 50 patients with metabolic syndrome.   "
128847|NCT01598597|"     This pilot, non-interventional, observational, Web-based, prospective cohort study is     designed to collect self-reported safety and effectiveness and genetic data from subjects     with locally recurrent breast cancer (BC) or metastatic breast cancer (MBC), metastatic     colorectal cancer (MCRC), metastatic non-squamous non-small cell lung cancer (MNSCLC),     recurrent glioblastoma (RGBM), or metastatic renal cell cancer (MRCC) in the United States     who have been previously treated with Avastin (bevacizumab). The cohort will be composed of     male and female subjects who have been diagnosed with locally recurrent BC or MBC, MCRC,     MNSCLC, RGBM, or MRCC who have received treatment with bevacizumab in combination with     chemotherapy, which started prior to or up to 31 December 2012. Participants will be     self-referred to this study. They will be recruited online via a number of sources, including     through the involvement of patient advocacy groups, social media tools, traditional media,     physicians, and events to raise awareness of this study. After appropriate informed consent     and authorization are obtained, data will be collected directly from subjects in an online     survey. Participants will be contacted electronically to complete quarterly follow-up     surveys. The follow-up period will be 1 year from responding to the baseline survey. DNA     collection will be performed as part of this study. DNA will be extracted from saliva, which     will be provided by the subject utilizing a collection kit sent to the participants for     at-home use.   "
128848|NCT01598584|"     Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression     has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a     high risk increase weight. So the investigators assume Mirtazapine would not only improve the     anxiety and depression of metastasis pancreas cancer but also would improve the appetite of     such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve     the quality of life in advanced pancreatic cancer which is of short survival.   "
128849|NCT01598571|"     Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer     dose.   "
128850|NCT01598558|"     Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells.     Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation     of extent of disease and response to therapy than the current standard of care, F-18 FDG     PET/CT.      The main purpose of the study is to investigate a new PET/CT imaging probe for detection and     follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma     patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability,     pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT     in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to     rituximab-based treatment in CD20-positive B-cell NHL   "
128851|NCT01598545|"     This study will investigate the dose of hydromorphone which will relieve the pain of women     following a cesarean section when delivered directly in the area around the spinal cord     (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal     hydromorphone that results in a pain score of less than 3 out of 10 12 hours after     intrathecal injection in 50% of women. Secondary objectives include determining the average     amount of time patients obtain pain relief after injection. Other secondary objectives     include determining the frequency and severity of side-effects associated with intrathecal     administration of hydromorphone, including: bradycardia, hypotension, respiratory depression,     apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and     delivery for planned cesarean section desiring will be consented for the study. The starting     dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method     of statistical analysis will be used, meaning that each subsequent dose will be dependent     upon the result obtained from the prior dose - ergo, if the initial subject has pain relief,     the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have     pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.      After the intrathecal injection is given, patients will undergo their cesarean section. The     patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire.     The patient's medical record will be reviewed to determine when she first requested     supplemental pain medication. A pain score of less than three will be a positive result. A     pain score of three or greater will be a negative result. Blood pressure, heart rate,     arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be     assessed.   "
128852|NCT01598532|"     The purpose of the study is to investigate whether transcranial, high-intensity LED placed on     the scalp can improve working memory in people who have sustained a concussion with lingering     effects or a mild brain injury.   "
128853|NCT01598519|"     The primary aim of this study is to examine whether a school-based suicide intervention is     effective in reducing suicide related risk factors in a population of middle and high     students. It hypothesized that receiving the intervention will reduce the severity of suicide     related risk factors such as depression, hopelessness, suicidal behaviors and increasing     protective factors such as social support, self esteem, suicide knowledge and attitude and so     on, as compared to the control group.   "
128854|NCT01598506|"     This study will investigate the dose of hydromorphone which will relieve the pain of women in     labor when delivered directly in the area around the spinal cord (i.e., intrathecal     injection). The primary objective is to determine the dose of intrathecal hydromorphone that     results in a pain score of less than 3 out of 10 thirty minutes after intrathecal injection     in 50% of women. Secondary objectives include determining this dose at five and ten minutes     after injection. Thirty women admitted to labor and delivery for planned vaginal delivery     desiring epidural placement will be consented for the study. The starting dose of intrathecal     hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical     analysis will be used, meaning that each subsequent dose will be dependent upon the result     obtained from the prior dose - ergo, if the initial subject has pain relief, the second     subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain     relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.      After the intrathecal injection is given and the epidural is placed, visual analogue pain     scores will be assessed 60 minutes following injection. A pain score of less than three will     be a positive result. A pain score of three or greater will be a negative result. Blood     pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will     also be assessed.   "
128876|NCT01598220|"     The purpose of this study is to determine whether computer-assisted cognitive remediation     therapy is effective in the treatment of cognitive deficits in schizophrenia.   "
128891|NCT01598025|"     Approximately 30% of patients who are candidates for bone marrow transplants do not have an     HLA-matched, or close to matched, donor available. For this reason, doctors have been testing     ways to make transplants from HLA-partially matched donors as safe and effective as     transplants from HLA-matched donors.      This study is being done to test the safety and the treatment results of a specific kind of     transplant. In this transplant, blood from two donors will be used. Each donor will share one     half of your HLA type. Blood from both donors will be transplanted at the same time.   "
128855|NCT01598493|"     Background:      Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing     invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of     activated carbon fiber impregnated with silver particles. The highly porous nature and the     large specific surface area of activated carbon fiber provide a tremendous adsorptive     capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray     emitted from activated carbon fiber accelerates blood circulation to stimulate tissue     regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through     penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial     investigates wound healing effects of BCT Antimicrobial Dressing on deep dermal burn     patients.      Aim:      To investigate wound healing effects of BCT Antimicrobial Dressing on deep dermal burn.      Methods:      This trial is expected to recruit 30 eligible subjects. After hospitalized patients are     diagnosed as deep dermal burn, the procedure of Informed Consent is conducted by the project     investigator. As long as the patient agrees to join this clinical trial and signs the     Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and     distributed to the control and research groups respectively by coin flipping. The wound in     the research group is first cleansed with normal saline and then applied with BCT     Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3     days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the     wound is healed. Flamazine is applied on the wound in the control group instead and then     covered with sterile gauze, and the frequency of dressing change is daily until the wound is     recovered. The healed and non-healed area of wound is recorded and photographed every 3 days,     and the wound color and infection are also evaluated. On Day 12 and Day 21, compare the ratio     of healing and non-healed areas in the control and research groups, and the ending point is     set on the 21st day.      Statistics Analysis:      Paired Student's t-test will be performed to analyze the clinical data by comparing the     difference of the healing percentage, the healing rate, the infection rate, and the frequency     of dressing change. It is statistically significant when P<0.05.   "
128856|NCT01598480|"     Background:      Bio-medical Carbon Technology (BCT) Antimicrobial Dressing, a novel advanced wound dressing     invented by Bio-medical Carbon Technology Co., Ltd., Taiwan, consists principally of     activated carbon fiber impregnated with silver particles. The highly porous nature and the     large specific surface area of activated carbon fiber provide a tremendous adsorptive     capacity for toxins, wound degradation products, and odors. Furthermore, far infrared ray     emitted from activated carbon fiber accelerates blood circulation to stimulate tissue     regeneration. Silver ions efficiently eliminate a broad spectrum of bacteria through     penetrating the cell wall of bacteria and denaturing essential proteins. This clinical trial     investigates wound healing effects of BCT Antimicrobial Dressing on superficial dermal burn     patients.      Aim:      To investigate wound healing effects of BCT Antimicrobial Dressing on superficial dermal     burn.      Methods:      This trial is expected to recruit 30 eligible subjects. After hospitalized patients are     diagnosed as superficial dermal burn, the procedure of Informed Consent is conducted by the     project investigator. As long as the patient agrees to join this clinical trial and signs the     Informed Consent, two separate areas of 25 cm2 in the same anatomic site are chosen and     distributed to the control and research groups respectively by coin flipping. The wound in     the research group is first cleansed with normal saline and then applied with BCT     Antimicrobial Dressing and covered by sterile gauze, and dressings will be changed every 3     days (counting from the day applied BCT dressings: Day0, 3, 6, 9, 12, 15……etc.) until the     wound is healed. Flamazine is applied on the wound in the control group instead and then     covered with sterile gauze, and the frequency of dressing change is daily until the wound is     recovered. The healed and non-healed area of wound is recorded and photographed every 3 days,     and the wound color and infection are also evaluated. On Day 12 and Day 21, compare the ratio     of healing and non-healed areas in the control and research groups, and the ending point is     set on the 21st day.      Statistics Analysis:      Paired Student's t-test will be performed to analyze the clinical data by comparing the     difference of the healing percentage, the healing rate, the infection rate, and the frequency     of dressing change. It is statistically significant when P<0.05.   "
128857|NCT01598467|"     The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy     for repair of pelvic organ prolapse in high volume european centers.   "
128858|NCT01598454|"     This study will be carried out in children with diagnosis of cancer with tumors known to     express N-glycolylated gangliosides. The disease must be resistant to conventional therapy.     The acute toxicity and immune response will be evaluated.      The expression of N-glycolylated gangliosides in tumors has previously been investigated in     the tumor sample bank at this Hospital. The expression of N-glycolyl GM3 was shown in     neuroblastoma, Ewing's sarcoma, Wilm's tumor and retinoblastoma.      Gliomas and the aforementioned tumor types have a very bad prognosis when conventional     treatment is ineffective.      New therapeutic strategies have thus been examined, and several immunotherapeutic approaches,     including dendritic cell vaccines, peptide vaccines and anti-idiotype vaccines are currently     being assessed.      Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies     in patients with melanoma, breast cancer and lung cancer.      Dose escalation studies have shown the safety of racotumomab in the 0.5 to 2 mg dose range.     The 1 mg dose level was selected for the ensuing clinical studies.      This clinical trial in children involves three dose levels: 0.15 mg, 0.25 mg and 0.4 mg,     owing to the difference in body surface between an adult (1.73 sq. m in average) and the     candidate population for this study (0.55 to 0.7 sq. m).   "
128859|NCT01598441|"     This study was designed to investigate treatment of postoperative pulmonary hypertension by     iloprost inhalation in children with congenital heart defects. It was a controlled     single-blind randomized multi-center prospective study in order to explore the efficacy of     this method in the treatment and prevention of pediatric pulmonary hypertension after     corrective open-heart surgery for congenital heart defects.   "
128860|NCT01598428|"     -  The purpose of this study is to evaluate effects of anterior capsule polishing on          effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by          measuring anterior chamber depth (ACD)        -  patients with bilateral age-related cataract undergo bilateral uneventful cataract          surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable          IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd          Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was          measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical          Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was          defined as the root mean square (RMS) of the change in ELP at each visit.   "
128861|NCT01598415|"     Study objectives:        -  Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety,          tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.        -  Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and          tolerability of a single intra-articular dose of SAR113945.   "
128862|NCT01598402|"     Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have     (during and shortly after this treatment) a high risk of developing pneumonia by aspiration.     This pneumonia is often associated with a hospital admission and affects the quality of life.      The purpose of the study, is to determine whether prophylactic antibiotics may decrease the     development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia     are already   "
128863|NCT01598389|"     The purpose of this study was to compare weight-discordant siblings in eating in the absence     of hunger, caloric compensation, and the quality of their habitual diet. The investigator     hypothesized that, within families and controlling for age differences, overweight and obese     siblings would show greater eating in the absence of hunger, poorer caloric compensation, and     poorer diet quality (e.g., increased percent of energy from fat and caloric beverages)     compared to normal-weight siblings.   "
128864|NCT01598376|"     Objective      To investigate the tissue reaction produced by implanted polyglactin suture material in     normal human skin and to determine the effect of suture gauge on this response.      Design      A prospective, double blind, randomized clinical trial using a novel ethical study design.     Both the patient and clinician analyzing the histology were blinded to the suture gauge used.      Participants      A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional     entropion and horizontal eyelid laxity, who provided written consent to participate, were     enrolled in the study.      Intervention      Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms     were alleviated during the wait for definitive surgery by the placement of temporary eyelid     everting sutures including a test suture. After 28 days, entropion correction was achieved by     a Quickert procedure which includes excision of an eyelid wedge. Histological analysis was     carried out, blind to the suture gauge used, on the excised eyelid containing the test     suture.      Main outcome measure      Defined histological parameters of suture-related granulomas were measured at multiple     levels. Data included granuloma outer diameter, central cellular diameter, giant cell number     and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels)     and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.   "
128865|NCT01598363|"     The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the     pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant     administration of bardoxolone methyl with digoxin or rosuvastatin.   "
128866|NCT01598350|"     On average, Down syndrome (DS) occurs once in every 700 live births and results in life-long     disability and increased risk for comorbidities.1 Individuals with DS are also susceptible to     secondary physical impairments and limitations as a result of complications associated with     joint hypermobility, hypotonicity, and increased ligamentous laxity. Secondary impairments     such as pes planus (flat feet), weakened muscles, bony abnormalities and arthritis may lead     to painful joints and feet. Additionally, children with DS often manifest deviations in gait     as a result of physical limitations imposed by orthopedic and muscular deficiencies that may     lead to decreased postural stability. These secondary losses in function, which exacerbate     disabilities, may be preventable with the use of appropriate early interventions aimed at     correcting abnormal joint alignment. Research exploring effective physical therapy     interventions for adults and children with DS is currently very limited. However, the use of     orthotic devices to support lax ligaments and hypotonic muscles, which are common     manifestations of DS, is one accepted method of intervention for children within this     population. Orthoses are variable in structure and the degree of support provided to the foot     and ankle also differ between foot orthoses (FOs) and supramalleolar orthoses (SMOs).     Previous studies have supported the effectiveness of orthoses on improving ankle and foot     alignment, as well as gait parameters. However, disagreement currently exists concerning     which type of orthotic device is most beneficial for the population of children with DS.     Children with DS express variable degrees of joint laxity and hypotonicity, as well as     differences in the severity of specific alignment abnormalities such as excessive pronation     or calcaneal eversion.6 Current literature is insufficient for explaining differences in the     benefits provided by FOs and SMOs and the specific indications for their use in children with     DS is unclear.      Study Aims This study will demonstrate the differences in structural outcomes provided by FOs     and SMOs and develop specific criterion for matching individuals of differing orthopedic     impairments with the most beneficial orthotic device.   "
128867|NCT01598337|"     This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel)     on the incidence of early and intermediate graft patency after CABG.   "
128868|NCT01598324|"     This is an ancillary study to a clinical trial that is being conducted at Massachusetts     General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy     of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399).     This observational study will involve magnetic resonance scans to examine brain chemistry     (neurotransmitter levels), brain activity, and functional connections between brain regions     before and after participating in the trial. The neurotransmitters of interest are glutamate,     glutamine, and GABA. Comparisons will be made between individuals who receive ziprasidone and     individuals who receive an inactive placebo. Differences between participants who respond to     standard antidepressants and those who require additional medication will also be examined.     All participants will have a baseline magnetic resonance scan before starting medication. The     second scan will be after 8 weeks of escitalopram treatment for those who respond or     following 8 weeks of escitalopram plus ziaprasidone or placebo (16 weeks after starting) for     those who do not respond to escitalopram alone. Participants will complete standard rating     scales for depression at each visit.   "
128869|NCT01598311|"     608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this     study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will     last for 10 days and participants will be followed up for at least 40 days and a maximum of     100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as     compared to vancomycin.   "
128870|NCT01598298|"     RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone     therapy. It is not yet known whether duloxetine hydrochloride is more effective than a     placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.      PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works     compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage     breast cancer receiving hormone therapy.   "
128871|NCT01598285|"     GEI-BEV-2011-01 is an Observational multicenter study. The study, involving 200 (100     non-responders and 100 best responders) metastatic breast cancer patients, will search for     specific genetic variants (SNPs) and miRNA signatures associated with bevacizumab response.     Only patients suffering from metastatic (disseminated at the time of diagnosis) breast     cancer, treated with bevacizumab, will be included.        1. -To identify genetic variants as bevacizumab response predictors in metastatic breast          cancer        2. To identify miRNA signatures in whole blood as bevacizumab response predictors in          metastatic breast cancer patients.      The main endpoint will be progression-free survival (PFS)      The duration of the study will be approximately 18 months   "
128872|NCT01598272|"     Determine the effects of 8 week Investigational Supplement on cellular detoxification and     gene expression profiles   "
128873|NCT01598259|"     The specific aims of this investigation in children during burn rehabilitation include 1.) to     determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.)     investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and     3.) develop a new methodology specific for burn patients that accurately screens for the     presence of intrinsic dyssomnia.   "
129530|NCT01589666|"     This study is a Phase 1, single-center, open-label, ascending dose study which will assess     the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma     (Resusix®) in healthy volunteers.   "
128877|NCT01598207|"     Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is     associated with poor quality of life and high health care expenditure of 8 Billion Dollars a     year.      Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological     issues may cause NCCP.      The mechanism(s) for pain continue to be explored and include central and peripheral     hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on     relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone,     or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly     there is a large unmet therapeutic need.      Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main     component of Cannabis acts through specific receptors, that are located primarily on central     and peripheral neurons (including the enteric nervous system) and myenteric plexus where they     modulate neurotransmitter release. Activation of these receptors reduces excitatory enteric     transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks     of NCCP.      STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux     chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and     esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom     diary and impedance planimetry. The primary outcome measure will be the frequency of chest     pain episodes. Secondary outcome measures include improvement in esophageal sensory     thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and     global improvement of symptoms.      HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in     NCCP patients, when compared to placebo.      AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a     CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of     action.   "
128878|NCT01598194|"     The goal of this clinical research study is to compare the performance of a newly available     needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles     to see which needle gives better diagnostic information for pancreatic lesions.   "
128879|NCT01598181|"     The purpose of this study is to investigate Transcranial Direct Current Stimulation as     treatment method for pain in fibromyalgia.   "
128880|NCT01598168|"     Heparin is an anticoagulant (blood thinner) that is commonly used to treat patients with     heart attacks and patients with blood clots in their legs or lungs (venous thrombosis). Some     patients develop an allergic reaction to heparin, a condition called heparin-induced     thrombocytopenia (HIT). HIT makes blood clot, which is the opposite of what heparin was     designed to do. These blood clots can lead to heart attacks, strokes, limb amputations, and     death. The objective of this 200 patient study is to determine if a new blood thinner called     rivaroxaban (Xarelto) can be used to treat HIT. Rivaroxaban can be taken by mouth, does not     require blood testing, and had a low risk of bleeding when it was used to treat blood clots     in other clinical trials. If this study shows that rivaroxaban can be used to treat HIT,     there will be two very important benefits. For patients with HIT, the benefit will be having     a safe, and easy-to-use drug to protect them from developing further life or limb-threatening     blood clots. For the Canadian health care system, the benefit will be having a drug that is     much less expensive than the drugs currently used to treat HIT.   "
128881|NCT01598155|"     Seventy patients will be previously treated for moderate-to-severe periodontitis according to     their individual needs. Thirty days after completion of periodontal treatment, these patients     will be randomized to one of the following groups of periodic preventive maintenance (PPM):     G1 - performed only control supragingival; G2 - performed supra and subgingival control (when     necessary).      The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis     is that the effect of the supragingival control (conducted over 24 months) will be similar to     the effect of the supra- and subgingival control combined, above the restoration and     progression of periodontitis.   "
128882|NCT01598142|"     The single-operator wire-guided cannulation technique doesn't require an experienced     assistant and precise coordination between the assistant and endoscopist.   "
128883|NCT01598129|"     The purpose of the study is to investigate the safety and the recommended dose for later use     of an oncolytic adenovirus CGTG-102 in combination with low-dose oral cyclophosphamide in the     treatment of advanced cancers.   "
128884|NCT01598116|"     Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all     have the potential for significantly harmful side effects. The purpose of this study is to     identify potential biomarkers that can be used to design clinical trials and accelerate the     delivery of new treatment alternatives to children with hemangiomas.   "
128885|NCT01598103|"     This study will assess the safety, tolerability and efficacy of SAF312 in patients with     overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who     qualify for this study is insufficiently managed by antimuscarinic therapy, or patients     poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be     primarily determined via urodynamic measurements.   "
128886|NCT01598090|"     The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined     with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis     C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.   "
128887|NCT01598077|"     This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or     recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV     infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or     HER2 overexpressing metastatic breast cancer or gastric cancer   "
128888|NCT01598064|"     Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the     junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation;     hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with     portal hypertension often suffer from infections from intestinal flora, the investigators     speculate that probiotics will be beneficial to those patients.   "
128889|NCT01598051|"     The objective of this study is to understand if Rivaroxaban can improve treatment     satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real     clinical practice.      A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey     will be conducted at month 0, 3, 6 using ACTS/TSQM.      This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a     local prospective and observational study of patients who have received Xarelto for SPAF.   "
128890|NCT01598038|"     The investigators hypothesize everolimus toxicities are linked to pharmacokinetic     variabilities of everolimus. Thus, early detection of clinical or biological risk factors     will lead to personalized dosage treatment and permit a better tolerance without altering     efficacy.   "
128892|NCT01598012|"     Ayurved Siriraj Prasaplai is a Thai traditional herbal drug for pain treatment. Mostly it was     used for antipain during menstruation or dysmenorrhea. This drug has been described by     alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and     showed clinical satisfied response. From review about this agent, it does not have clinical     trial to prove its efficacy. So the author produce this research to study in efficacy of     Ayurved Siriraj Prasaplai.   "
128893|NCT01597999|"     This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist     in early breast cancer with poor prognostic features.   "
128894|NCT01597986|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.   "
128895|NCT01597973|"     Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are     non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to     treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or     pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter     baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa     that demonstrates in vitro non-susceptibility defined as extensively drug-resistant     Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both     BSI and pneumonia at the time of study enrollment, they will be included as a subject with     pneumonia.      Objectives:      Primary:      •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a     carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared     to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to     XDR-GNB.      Secondary:      •Determine what treatment regimen (colistin monotherapy or colistin combined with a     carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin     resistance among XDR-GNB isolates during therapy.   "
128896|NCT01597960|"     The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and     this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk. It     is hoped that a better understanding of the value of this therapy will provide a sound     scientific basis for including yoga in mainstream clinical practice. The investigators     propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited     from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an     acute coronary syndrome. Those who agree will undergo a series of baseline and follow-up     measurements. 20 Indian Asians and 20 Europeans will be randomized to the yoga intervention     plus their standard cardiac rehabilitation programme (usual care), and the remaining 20     Indian Asians and 20 Europeans will be randomized to usual care alone. Baseline and follow-up     measurements will be performed on all participants. In order to determine the acute effects     of yoga the group randomised to the yoga intervention will also undergo a series of acute     tests before and after their first yoga session.   "
128897|NCT01597947|"     This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess     the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will     take place in the US at one clinical site.   "
128898|NCT01597934|"     Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result     in faster and greater antiviral activity and lower rates of resistance emergence over     maintaining Lamivudine(LAM)/Telbivudine(LdT)+Adefovir(ADV) combination in partial responders     to LAM/LdT+ADV rescue therapy.      Earlier switching to combination with the most potent regimen will be more effective to     achieve virologic response(VR) and prevent further resistance emergence.      All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be     assessed at baseline and every three months thereafter. Evaluations at each visit will     include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse     events. At baseline and every six months thereafter, serum will be assayed for HBV serology.     Genotypic analysis will be performed at baseline and 48 weeks.   "
128899|NCT01597921|"     The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of     acute radiation dermatitis in patients with breast cancer receiving radiotherapy.   "
128900|NCT01597908|"     This is a two-arm, open-label, randomised, Phase III study comparing dabrafenib (GSK2118436)     and trametinib (GSK1120212) combination therapy to vemurafenib. Subjects with histologically     confirmed cutaneous melanoma that is either stage IIIc (unresectable) or stage IV, and BRAF     V600E/K mutation positive will be screened for eligibility. Subjects who have had prior     systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible     although prior systemic treatment in the adjuvant setting will be allowed. Approximately 694     subjects will be randomised 1:1 (combination therapy:vemurafenib). The primary endpoint is     overall survival (OS) for subjects receiving the combination therapy compared with those     receiving vemurafenib.   "
128901|NCT01597895|"     The purpose of this study is to determine the effect that telaprevir and boceprevir has on     the pharmacokinetics of maraviroc.   "
128902|NCT01597882|"     The UK population is ageing and the likelihood of having a long term health condition     increases with age. Three out of every five people over 60 in the UK have a long term     condition. Ageing and having a long term condition increases the chance of having difficulty     being independent and carrying out day to day activities. In recent years the NHS has made a     greater effort to prevent these difficulties in patients with long term conditions.      One approach to help patients with long term conditions is case management, where by     (usually) a community matron visits patients at home, looking for early warning signs of any     worsening of their condition and arranging care and treatment. But the current way this is     done varies across the country and hospital admissions are still rising. In order to give the     right care at the right time, effective monitoring is needed to help the community matron     detect and act on changes in the patient's condition.      Loss of muscle strength in old age is linked to a poor health, but it is not known whether     simple measures of muscle strength could be used to detect and predict declines in health in     the short to medium term to help maintain independence and prevent an accident or hospital     admission.      The aim of this study is to look at whether monitoring muscle strength in case managed     patients is practical, acceptable and useful in detecting when a patient's condition worsens.     Each patient will be visited by the researcher in their home twice in the first week, then     once every two weeks, for another 5 weeks, to carry out three simple measures of grip and     respiratory strength, and complete questionnaires about their health and ability to carry out     day to day activities. Each visit will last about 20 to 30 minutes. A small group of     clinicians will be asked about their views of the strength measures. Database analysis will     allow descriptive data on the patient group to be gathered and analysed.   "
129531|NCT01589653|"     This trial is conducted in Africa and Asia. The aim of the trial is to compare     patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in     type 2 diabetes patients uncontrolled on NPH insulin.   "
128903|NCT01597869|"     The purpose of this study is to find all kinds of complications and it's frequency related to     the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to evaluate     associated risk factors in patients who developed complications. The investigators performs     EBUS-TBNA examination on all subjects that need mediastinal evaluation. All complications     during or after the procedure will be recorded prospectively.   "
128904|NCT01597856|"     Veterans can apply for compensation and pension (C & P) benefits for a disability related to     military service. The application exam for these benefits provides an opportunity for     Veterans returning from service to access VA care. The investigators will recruit Veterans     applying for C & P to participate in this study. All enrolled participants will complete     questionnaires around the time of their C & P exam related to substance abuse, PTSD, service     use, and attitudes. The investigators will monitor enrolled Veterans' attendance at treatment     over time, and examine whether C & P award, substance use, and beliefs about benefits are     related to treatment attendance. Some enrolled participants will be assigned to one of two     study groups: a treatment group and a no-additional-treatment group. People assigned to these     groups will complete the same substance abuse, PTSD, service use, and attitudes     questionnaires two additional times during the study. Participants assigned to the treatment     group will receive information about the relationship between substance use and PTSD and will     be referred to relevant treatment. The investigators will test whether Veterans who receive     no-additional-treatment have different symptoms over time and attend less treatment sessions     (mental health or substance abuse) than people assigned to treatment.   "
128905|NCT01597843|"     This project will design, deliver, and evaluate a peer support intervention that will help     veterans become familiar with and register for Veterans Health Administration (VHA) My     HealtheVet (MHV). It will lay the groundwork for 2 types of future projects. First, the     investigators will develop materials that can be used in other settings to increase     registration, authentication, and meaningful use of MHV. Second, it will allow us to develop     and study interventions that use informed, peer-supported Internet use to improve health     behaviors and outcomes among veterans.   "
128906|NCT01597830|"     This study evaluates the effects of specialized footwear on pain and knee loading in knee     osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and     knee pain.   "
128907|NCT01597817|"     Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by exacerbations     and remission of intensely pruritic lesions of variable location. AD may be acute (short-term     and severe) with predominantly redness, vesicles and oozing, or it may be chronic (long-term)     with scaling, skin thickening, altered pigmentation and exaggerated surface markings. The     condition affects mainly the creases of the elbows and knees, and the face and neck, although     it can affect any part of the body. The severity of AD is variable, ranging from localized     mild scaling to generalized involvement of the whole body. Itching is the predominant     symptom, which can induce a vicious cycle of scratching, leading to skin damage. There is a     tendency to lifelong dry sensitive skin. Skin of AD is often colonized by Staphylococcus     aureus contributing to perpetuating cutaneous inflammation. AD treatment is based on skin     hydration, identification and elimination of flare factors, and pharmacologic therapy.     Biofunctional textiles are emerging as new and complementary tools . Chitosan is a natural     polysaccharide with in vitro anti-microbial activity and regenerating properties. The     investigators aim to evaluate the effect of a textile coated with chitosan in AD treatment as     well as its impact on systemic inflammation and skin microbiome. The investigators     hypothesize the use of biofunctional textile coated with chitosan will improve severity of AD     , quality of life and diminish skin colonization with Staphylococcus aureus and some skin     moulds, namely Malassezia.   "
128908|NCT01597804|"     This pilot clinical trial studies bathing bundle regimen in reducing gynecological surgical     site infection in patients undergoing surgery. A bathing bundle regimen may reduce the risk     of wound infection, extended length of hospital stay, readmission into the hospital, and the     overall healthcare costs in patients undergoing surgery.   "
128909|NCT01597791|"     The investigators hypothesize that many parturients can, in fact, spontaneously micturate     with low dose combined spinal epidural analgesic doses given for labor and that Foley     catheterization is unnecessary in the majority of these parturients. At Prentice Women's     Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those     receive Foley catheters. By potentially reducing the necessity for Foley catheters, the     investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract     infections and urethritis leading to unnecessary treatment with antibiotics, as well as     reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving     low dose combined spinal epidural analgesia for analgesia after induction of labor who are     randomized to a spontaneous micturition protocol will require fewer Foley catheter placements     and demonstrate a lower incidence of positive urine culture postpartum than those who undergo     standard Foley catheter placement.   "
128911|NCT01597765|"     The purpose of this study is to determine the efficacy of antioxidant cocktails on the     alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.   "
128912|NCT01597752|"     The objective of this study is to determine the biologic activity of a Blomia tropicalis     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house     reference preparation (IHRP).   "
128913|NCT01597739|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of     JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients     with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD)     therapy.   "
128914|NCT01597726|"     The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming     to laminaria priming among women undergoing D&E at 13-20 weeks gestation in the Western Cape     Province, South Africa   "
128915|NCT01597713|"     This trial is conducted in Europe. The aim of this trial is to investigate the safety,     tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of     NNC 0148-0000-0362 as tablets in healthy volunteers.      The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362,     placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC     0148-0000-0362 administered orally or intravenously.   "
128916|NCT01597700|"     Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by     Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of     Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study.     Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and     given their informed consent will be entered into the study. They will be fasted and receive     one tablet by mouth in accordance with a randomisation list and blood samples will be taken     at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will     receive the opposite tablet and the clinical process repeated. Subjects will be continuously     monitored while in the trial clinic and at ambulatory visits with regular measurements of     vital signs and questioned for adverse events. Drug concentrations will be analysed and these     results compared to ascertain bioequivalence by applying statistical methods to the     pharmacokinetic data; this information and all safety data will be formally reported.   "
128917|NCT01597687|"     This study aims to determine the burden of pertussis infection among adolescents and adults     with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and     Thailand. This study also aims to assess the health economic (HE) impact of pertussis.   "
128918|NCT01597674|"     The objective of the study was to assess whether the tolerance to the effect of YF476 on     gastric pH observed with repeated doses in a previous study in healthy volunteers can be     avoided by using smaller doses of YF476.   "
128919|NCT01597661|"     Bupropion is a unique drug that is used both to treat depression and as an aid in smoking     cessation. In 2008, the final report from the Bupropion pregnancy registry described 24     congenital malformations among the 675 women exposed to bupropion in the first trimester of     pregnancy. Of these, 9 had congenital heart disease of varying severity, including a number     of infants with ventricular septal defects (VSDs); of note, 2 of these 9 had coarctation of     the aorta. More recently, Alwan et al, in an analysis of data from the Centers for Disease     Control and Prevention's case-control National Birth Defects Prevention Study, reported an     increased risk of left outflow tract heart defects, a subgroup of cardiac malformations that     includes coarctation of the aorta and hypoplastic left heart syndrome.      Data from the Slone Epidemiology Center Birth Defects Study will be used to test these     observations. The outcomes of primary interest will include those hypothesized to be     associated with bupropion in recent studies: left outflow tract defects considered as a     group. Coarctation of the aorta and hypoplastic left heart syndrome will also be examined     separately. All infants with congenital heart defects are further classified into subgroups     that are embryologically meaningful, including left outflow tract defects. In secondary     analyses, other heart defect classes for which there are adequate numbers of cases will be     evaluated.   "
128920|NCT01597648|"     This is a study in healthy adult subjects to evaluate the bioequivalence of a Combined     Formulated Tablet compared with maraviroc and Combivir administered concurrently versus     maraviroc + Combivir. 42 subjects will be enrolled in the study such that 40 subjects     complete dosing and critical assessments. The total duration of a subject's participation     will be approximately 33 to 35 days, including a screening period (Day −21 to Day −1), 2     treatment periods (Days 1-3), at least a 7-day washout between Period 1 and Period 2, and a     follow-up visit 7 to 14 days after the last dose of study drug in Period 2. Each dosing     period will begin the evening prior to dosing and extend until 48 hours (Day 3) after dosing.     Subjects will be randomly assigned to receive 1 of the following 2 treatments in Period 1     then crossover to receive the alternate treatment in Period 2:      In Sequence 1 (N=21) subjects will receive Treatment A followed by a 7 day washout and     Treatment B. In Sequence 2 (N=21) subjects will receive Treatment B followed by a 7 day     washout and Treatment A. Treatment A consists of 1 tablet of maraviroc 300 mg, lamivudine 150     mg, and zidovudine 300 mg as a combined formulation after an overnight fast. Treatment B     consists of 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an     overnight fast. On Day 1 of each treatment period, subjects will receive study drug in the     morning after an overnight fast of at least 8 hours. Study drug will be administered with 240     mL of water. Dosing in each treatment period will be separated by a minimum washout period of     at least 7 days between doses. All subjects will undergo safety and other assessments.     Subjects may be discharged after all study procedures are completed on the morning of Day 3,     with instructions to return for the next study period or the follow-up visit, as appropriate.     The follow-up visit will occur 7 to 14 days after the last dose of study drug in Period 2.     Pharmacokinetic blood samples will be collected during each treatment period for evaluation     of maraviroc, lamivudine, and zidovudine before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3,     4, 6, 8, 12, 18, 24, 36, and 48 hours after dosing (total of 16 PK time points per treatment     period). Protocol waivers or exemptions are not allowed, with the exception of immediate     safety concerns. Therefore, adherence to the study protocol requirements, including those     specified in the Time and Events Table, are essential and required for study conduct.   "
128921|NCT01597635|"     This is an early phase (phase IIa), randomized, multi-center study in subjects with acute     lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is     to investigate the safety of GSK2586881 and to determine what effects it has on people with     Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).      The study has two parts: Part A will be an open-label investigation in five subjects. Part B     will be a double-blind, placebo controlled investigation and will involve approximately 60     subjects.   "
128922|NCT01597622|"     This study provides subjects who complete the BEL113750 study and subjects who complete the     open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of     continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those     randomized to belimumab, or the option to begin treatment with belimumab for those randomized     to placebo, as an add-on to their standard of care SLE therapy.   "
128935|NCT01597453|"     NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60     years. Patients, partners and the couple´s adult children who are at least 18 years old, are     all invited to ultrasound examinations due to a standardized protocol.      Parents of patients and partners are invited to return their answers of standardized     questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction     or peripheral artery disease.      Study inclusion time of patients and their families is 5 years. A biobank is build from     samples from patients, partners and adult children. Clinical follow-ups for patients and     partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are     planned after 10 and 20 years.      Hypotheses:      What do patients know about their parents clinical ischemic events? How much established     pathology in arteries do we find by a standardized ultrasound protocol at the time of     ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings     between patients and partners? Differences between children from families with several     ischemic events among parents and grandparents vs. children from families without ischemic     events? Biochemical markers related to ultrasound findings and artery disease.   "
129181|NCT01594242|"     The purpose of this study is to better understand the effects of the chemotherapy medication     bortezomib on cancer cells. The investigators are therefore taking blood and bone marrow     samples from patients with myeloma who are receiving bortezomib to see if the investigators     can detect autophagy in the myeloma cells from the bone marrow and in immune cells in the     blood. Subjects are eligible if their doctor is planning to treat them with bortezomib for     the first time for their myeloma.   "
128923|NCT01597609|"     Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark     study to investigate the physiological changes associated with weight loss and regain. The     aim is to estimate the changes in body composition during and after three interventions (i)     calorie restricted diet + a marketed anti-obesity drug (sibutramine )(ii) calorie restricted     diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise. The     interventions will last 12 weeks, after which there is a further 12 week observation period     during which subjects will return to their normal lifestyle and are expected to regain     weight. Additionally, a range of biomarkers may be evaluated to determine whether there are     correlations at early and late time points with weight and fat loss and weight and fat     regain. The changes in body composition and other biomarkers will be used to determine     whether mathematical models can be built that predict the weight loss and regain of     individual subjects. In addition, the usefulness of tools that may aid the physiological     characterisation of weight loss/regain will be assessed, in particular methods for measuring     energy expenditure and energy intake such as ambulatory activity meter, Sussex Ingestion     Pattern Monitor ™ (SIPM), hunger-satiety VAS, indirect calorimetry and, if available, the     Theranos in-home graphical user interface (GUI) portal. Knowledge of the body composition     changes resulting from these typical weight loss interventions and predictive markers of     response would facilitate the design of future studies for novel anti-obesity agents and     allow earlier, more informed triaging of NCEs.   "
128924|NCT01597596|"     A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of     alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who     had been diagnosed with infantile-onset Pompe disease. Participants were treated with     alglucosidase alfa 160 L scale product in the United States (US) and 4000 L scale product in     the regions outside the US.   "
128925|NCT01597583|"     The main aim of this study is to conduct a randomized control trial to compare     MobileMedMinder, a mobile phone based medication reminder software product, with currently     accepted and empirically supported methods for increasing medication compliance through     reminders and tracking.   "
128926|NCT01597570|"     It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure     System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis)     and ambulation (TTA; Time to ambulation) at the puncture site of common femoral artery (CFA)     after the procedures of Fastseal® Biosorbable Vascular Access Closure System or Perclose®     ProGlide Suture-Mediated Closure System during 1 month observation.   "
128927|NCT01597557|"     The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium     sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the     energy threshold (in J) required for successful cardioversion of atrial fibrillation into     sinus rhythm.   "
128928|NCT01597544|"     This study is divided into two parts. The first part is a prospective observational study of     patients undergoing pelvic organ prolapse (POP) surgery. The goal is to determine patient     preference between 3 different methods of bladder drainage in case of post-operative voiding     dysfunction (POVD): transurethral indwelling catheterization (TIC), clean intermittent     self-catheterization (CISC), and suprapubic tube (SPT). The second part of the study will be     for those that choose CISC as their preferred method, whereby these patients will be     randomized to receive CISC instruction either pre- or post-operatively to determine whether     there is a difference in overall patient satisfaction based on timing of teaching.      The investigators hypothesize that patients that receive informed consent pre-operatively     will favour the use of SPT over TIC and CISC to manage potential POVD.      Among those patients who opted for CISC in management of their post-operative voiding     dysfunction, patients that are taught how to perform CISC pre-operatively in the clinic will     have a higher level of satisfaction compared to those that are taught post-operatively in the     hospital.   "
128929|NCT01597531|"     The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric     banding can improve remission of type 2 diabetes.   "
128930|NCT01597518|"     The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of     patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at     a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after     injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as     measured by International Standards for Neurological Classification of Spinal Cord Injury     Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the     hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of     riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of     life outcomes, health utilities, mortality, and adverse events. The working hypothesis is     that the riluzole treated subjects will experience superior motor, sensory, functional, and     quality of life outcomes as compared to those receiving placebo, with an acceptable safety     profile.   "
128931|NCT01597505|"     608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this     study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will     last for 10 days and participants will be followed up for at least 40 days and a maximum of     100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as     compared to vancomycin.   "
128932|NCT01597492|"     The purpose of this study is to assess the impact of belimumab on immune response to     pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).   "
128933|NCT01597479|"     The aim of this clinical trial is to determinate if distal ultrasound guided peripheral nerve     blocks on target nerves (radial and median nerve blocks at the elbow), using low volume and     low concentration of long acting local anesthetic provide better postoperative pain control     compare with systemic analgesia alone after thumb resection arthroplasty (TRA) due to a     prolonged selective sensitive block on the tissue trauma.   "
128934|NCT01597466|"     The purpose of this study is to evaluate the use of the Epidrum device to identify the     epidural space in patients requiring thoracic epidural analgesia.   "
129532|NCT01589640|"     This is a single center clinical study designed to determine patient satisfaction and the     effect of the use of artificial tears on tear osmolarity with time after instillation of     three commercially available artifical tear eye solutions ( Blink Tears, Blink Gel Tears and     Systane Balance).   "
128936|NCT01597440|"     Background: Very few drugs exist that treat hyperammonemia, specifically PA and MMA. Diet     restrictions and alternate pathway agents are the current primary treatments, but they     frequently fail to prohibit brain damage.      Orthotopic liver transplantation cures the hyperammonemia of urea cycle disorders, but organ     availability is limited and the procedure is highly invasive and requires life-long     immunosuppression.      A drug that could repair or stimulate a dysfunctional urea cycle such as this would have     several advantages over current therapy. A drug called N-carbamyl-L-glutamate, Carglumic acid     (NCG or Carbaglu)has recently been found to be virtually curative of another urea cycle     defect called NAGS deficiency. In this disorder, treatment with NCG alone normalizes     ureagenesis, blood ammonia and glutamine levels, allows normal protein tolerance and restores     health. Knowledge from this study is being applied to acquired hyperammonemia, specifically     in patients with propionic PA and MMA, to try and improve neurodevelopmental outcomes by     improving the hyperammonemia.      Aims: The overall objective of this project is to determine whether treatment of acute     hyperammonemia with Carglumic acid in propionic acidemia (PA), methylmalonic acidemia (MMA)     changes the long-term outcome of disease and to determine if it is effective in restoring     urine ammonia levels to normal levels.   "
128937|NCT01597427|"     The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary     artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.   "
128938|NCT01597414|"     Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast     cancer. Chemotherapy however is associated with significant side-effects and can impact on     Quality of Life and functionality in older patients.      The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to     delay or even avoid the use of classical chemotherapy because of competing risks of death in     this frail/elderly patient group.   "
128939|NCT01597401|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and     pharmacodynamic effects of Aes-103 (active ingredient 5-hydroxymethyl-2-furfural [5-HMF])     compared with placebo in subjects with stable sickle cell disease (SCD). Safety will be     measured by monitoring adverse events (AEs), electrocardiograms (ECGs), vital signs, and     laboratory values. Pharmacokinetics of Aes-103 will be measured over time in plasma, red     blood cell hemolysate and binding of Aes-103 to hemoglobin. Pharmacodynamic effects will be     assessed by measuring partial pressure of oxygen at which 50% of hemoglobin is saturated with     oxygen (p50) while breathing normal air, blood oxygen levels (SpO2), ex-vivo antisickling     effects in a hypoxic environment, and by imaging related changes in tissue blood flow and     oxygen levels.   "
128940|NCT01597388|"     The purpose of this study is to assess safety and tolerability of AZD2014 when given in     combination with Fulvestrant.   "
128941|NCT01597375|"     The investigators are doing this research study to find out if giving a drug called     prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people     with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every     day can work as a treatment for people with AERD. People with AERD have symptoms of asthma,     severe runny nose, polyps in the nose, and develop allergic reactions if they take     medications like aspirin.      People with AERD can be desensitized to aspirin in order to be able to safely use it daily,     but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a     safer way for people with AERD to tolerate aspirin.      The investigators also want to understand what is different about the cells and urine from     subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and     subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to     understand how aspirin acts differently in subjects who have AERD, in comparison to subjects     who have asthma but do not have AERD.   "
128942|NCT01597362|"     The study compares the Veress needle technique, the Direct trocar insertion and the Open     technique with each other, in terms of minor complications, in elective laparoscopic     procedures for benign pathologies.   "
128943|NCT01597349|"     The purpose of this research study is to learn how effective and safe FP01 lozenges are when     given to subjects with a cough due to an upper respiratory tract infection. The study will     include subjects who have an upper respiratory tract infection, with a cough of less than six     weeks duration.   "
128944|NCT01597336|"     The objective of this study is to evaluate the utility of fibrinolysis when draining an     abdominal abscess as defined by length of stay after drainage.   "
128945|NCT01597323|"     Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light     based device for the treatment of facial wrinkles.   "
128946|NCT01597310|"     This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the     CYP2C9 probe substrate warfarin in healthy volunteers.   "
128947|NCT01597297|"     The objectives of this study in Multiple Sclerosis (MS) participants treated with     prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated     with placebo are to assess the effect over 24 weeks on the following parameters to explore     endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static     balance, subjective impression of well-being, and participants' global impression of change     in walking . Another purpose of this study is to evaluate the safety and tolerability of     prolonged-release fampridine.   "
128948|NCT01597284|"     The investigators propose to evaluate the compliance of oral cancer therapies, particularly     the possible link between this observance and cognitive function of patients at initiation of     treatment. To our knowledge, this study will be among the first conducted on the issue in     France and is an innovative approach in the management of cancer patients. The inclusion of     cognitive dysfunction is part of a comprehensive approach to improving the quality of life     and fully meets the objectives of both plans cancer, including those of the axis Living     during and after cancer highlighted in the Cancer Plan   "
128949|NCT01597258|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy     of this drug.   "
128950|NCT01597245|"     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to     etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.   "
128951|NCT01597232|"     Guidelines for blood transfusion have been issued for years. According to these guidelines,     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the     guidelines, the determination of whether RBCs should be administered when the hemoglobin     level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or     surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and     10g/dL is necessary and important in clinical practice.      Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen     consumption, the investigators hypothesize that index of transfusion trigger for patients     with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including     infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired     oxygen, core temperature, and angina. To verify this hypothesis, the investigators present     West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according     to the patient's history and monitoring parameters, and the investigators design a randomized     controlled clinical trial to test this score.   "
128952|NCT01597219|"     This trial investigates stem cell transplants from partially mismatched donors in patients     with blood and bone marrow cancers. The trial will test two kinds of transplants - a full     intensity transplant using a high dose of radiotherapy and chemotherapy, and a reduced     intensity transplant with lower doses of chemotherapy and radiotherapy. Patients will be     entered for the treatment pathway that is most appropriate for their level of health and     fitness   "
128953|NCT01597206|"     Dental services for large sectors of the population of the Western Cape (WC) Province of     South Africa (SA) has been, and continues to be, limited to low-cost treatment options and     emergency services, such as extractions at public health clinics. Replacement of missing     teeth for the disadvantaged majority of the population is provided almost exclusively at the     dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result     of disease and the lack of restorative care and then having these replaced by a removable     partial denture, if the patient can afford it Null Hypothesis: The daily functional needs and     quality of life of partially dentate adult patients with a reduced posterior dental arch and     /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the     posterior teeth with a removable prosthesis.   "
128954|NCT01597193|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in     patients with incurable breast cancer.   "
128955|NCT01597180|"     The purpose of this trial is to learn about potential interactions between raltegravir and a     birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on     steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40,     inclusive, who report regular monthly menses.      The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE)     and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular     medical care. Women will be enrolled in the study for approximately 8 months.   "
128956|NCT01597167|"     The proposed study is a 1-week, randomized, double-blind, placebo-controlled, trial to     evaluate the efficacy of an IV infusion of magnesium sulfate on symptoms of treatment     resistant mild and moderate depression in 20 males and females (21-70 years of age).     Participants will be assessed at screening/baseline, day 1, day 2, day 7, and day 8. Each     subject will be randomized in a double-blind fashion to receive either IV infusion of     magnesium sulfate or 5% dextrose followed by a washout period of 5 days then crossover to     receive either IV infusion of 5% dextrose or magnesium sulfate.   "
128957|NCT01597154|"     Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased     physical activity and dietary changes) for the management of glycemia and cardiometabolic     risk factors in children and adolescents with type 2 diabetes (T2DM).      Our hypothesis is that education regarding healthy lifestyle changes will significantly     reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary     hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions     in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL     cholesterol, serum triglycerides and apolipoprotein B.   "
128958|NCT01597141|"     The primary aim of this application is to conduct a randomized, controlled clinical trial of     a specialized mental health service delivery system specifically developed for prodromal     psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT).     The goal of the treatment is prevention of psychosis and disability. This study will assess     experimentally the clinical effectiveness of this new type of mental health service. Other     domains of outcome include cognitive dysfunction and functional disability.   "
128959|NCT01597128|"     This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE®     Reconstructive Tissue Matrixin the repair of hernias.   "
128960|NCT01597115|"     The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular     access surgery with native vein for hemodialysis can increase the maturation rate of     arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1     randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2     and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks     after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after     surgery by duplex in all patients.   "
128961|NCT01597102|"     The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy.     Patients with the indication to liver transplantation mostly have mild to severe hepatic     encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to     investigate the AR during liver transplantation, with the questions if the AR is impaired at     the beginning of surgery and if there are changes in AR. For follow up the AR will be     measured at the first days after transplantation at the ICU.   "
128984|NCT01596803|"     On the basis of published data and the investigators' results indicating that oxidative     stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD,     the investigators propose a study to test whether or not an antioxidant supplementation has a     therapeutic interest for patients with FSHD. Their results have important implications for     the successful implementation of rational antioxidant therapy in FSHD in which cell loss     could be linked to oxidative stress.   "
128962|NCT01597089|"     Background:      - Bronchoalveolar lavage (BAL) is a procedure where a tube is passed through the mouth or     nose into the lungs. Fluid is squirted through the tube into a part of the lung and then     collected for examination. It is used to detect respiratory viruses. BAL is a relatively     invasive procedure, and researchers want to test the accuracy of other procedures that do not     involve collecting fluid from the lungs. The nasopharynx is the area of the upper throat that     lies behind the nose. Researchers want to see if a swab taken from this area is as accurate     as a BAL sample.      Objectives:      - To see if a nasopharynx swab can be used to detect respiratory viruses as well as BAL     samples.      Eligibility:      - Individuals at least 12 years of age who will have a bronchoscopy to collect a BAL sample     to test for respiratory viruses.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have a BAL sample collected.        -  Participants will then have a nasopharynx swab. The swab will be inserted into the nose,          left in place for up to 10 seconds, and then removed   "
128963|NCT01597076|"     The objectives of this clinical trial are to evaluate the effectiveness of an iridoid     enriched beverage containing noni and cornelian juices and olive leaf extract on advanced     glycation end product levels.   "
128964|NCT01597063|"     Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled.     Study blood will be collected in the first or second trimester at a scheduled prenatal     screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will     be followed until delivery and the birth outcome recorded.   "
128965|NCT01597050|"     The purpose of this study is to determine the safety, efficacy and tolerability of topical     R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)     patients with active discoid lesions.   "
128966|NCT01597037|"     The purpose of this study is to evaluate how changing different conditions of the     speech-language treatment (such as cues, feedback, complexity and practice schedule) affects     the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension     and expression of spoken and written language) following a stroke.   "
128967|NCT01597024|"     The primary aim of this work is, to 'relate psychological and behavioural parameters of     hunger/satiety and food preference to gut hormones, neural activation and energy metabolism     by dietary manipulation, across the human lifespan'.   "
128968|NCT01597011|"     In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is     either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue     (Tisseel/Tissucol) or left unfixated.      The investigators believe, and previous studies indicate, that the use of fibrin glue greatly     reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in     men or recurrence of the hernia)when compared with the use of tacks or staples.      The aim of this study is to compare the recurrence rates and amount of postoperative     complications in patients who have had inguinal hernia repair with fibrin glue and in     patients who have had inguinal hernia repair with tacks, staples or sutures.   "
128969|NCT01596998|"     The aim of this study is to determine the effect of the addition of vasoconstrictor in the     plasma concentrations achieved and the extent of the transversus abdominis plane block in     healthy male volunteers.   "
128970|NCT01596985|"     Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation     using the PlasmaJet system versus cystectomy, using postoperative examination by 3D     ultrasound.      Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two     University tertiary referral centers.      Patients: Fifty women with no previous history of ovarian surgery managed for unilateral     ovarian endometrioma > 30 mm in diameter.      Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian     tissue sparing cystectomy.      Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume     and antral follicle count (AFC) .   "
128971|NCT01596972|"     The primary aim of this study is to determine if a self-administered semi-quantitative urine     pregnancy test and telephone pregnancy symptom questionnaire can reduce the percentage of     women with a complete uterine evacuation who require a clinic or lab visit to confirm     completion.      The investigators hypothesize that women with complete uterine evacuation will be less likely     to require a follow-up clinic or lab visit by using a standardized pregnancy questionnaire     and home SQ-UPT, than by using serum hCG as the objective measure of completion.   "
128972|NCT01596959|"     This study will be a single blind prospective randomised control trial in patients undergoing     ablation for the treatment of typical atrial flutter, with the aim of investigating the     benefit of a new impedance-based computer software application which measures tissue contact     between the ablation catheter and the inside of the heart.      The investigators hope to demonstrate that the use of this tissue contact information reduces     ablation time, Xray time, and procedure time required to complete the procedure successfully.     Study participants will be randomly assigned to undergo their procedure with or without this     contact data displayed for the doctor performing the ablation to see. The acute procedural     endpoint of ablation is successful conduction block across the cavotricuspid isthmus of the     right atrium. If the outcome of this study is positive, it will have a significant beneficial     impact on this procedure, reducing procedure length, patient discomfort, and potentially     reducing risk for the patient, recurrent arrythmia symptoms, and the need for repeat     procedures later on.   "
128973|NCT01596946|"     Though partner notification is mandatory to perform of Chlamydia trachomatis infected     individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997     and 2007 indicating that partner notification may not be effective in preventing     transmission. The investigators wanted to determine whether there was any difference in time     between home-sampling and clinical testing as a tool of partner notification measured from     eliciting of partners to date of testing.   "
129026|NCT01596257|"     The purpose of this study is to find out if getting a blood stem cell transplant with donor     stem cells given over several days is better than getting a blood stem cell transplant with     donor stem cells given over 1 day. We want to find out which procedure over will result in     improved recovery of blood and immune function after transplant. When donor stem cells are     given over various days in mice, the blood and immune system recovery is quicker.   "
129533|NCT01589627|"     The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for     wrist extension contracture following a distal radius fracture.   "
128974|NCT01596933|"     Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from     an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by     cachexia. Head and neck (H&N) cancer patients are nutritionally vulnerable since tumour     localisation can interfere with food intake, since alcohol and tobacco abuse - two     etiological risk factors of H&N cancer - are associated with nutritional deficits, and since     the intensive treatment can lead to progressive weight loss. Recently, omega-3 fatty acids     have gained interest for their beneficial effects in several diseases. Moreover, nutritional     supplementation enriched with omega-3 FA could potentially maintain body weight in cancer     patients undergoing intensive treatment.      Aims In this study, the investigators want to evaluate the use of omega-3 FA supplementation     as nutritional and the investigators would like to identify potential risk factors,     biomarkers and objective measurement tools which can predict therapy-induced cachexia.   "
128975|NCT01596920|"     The primary objective of the present study is to further establish in a randomized controlled     trial, the safety and efficacy of weekly Grafix® administration versus control in patients     with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the     index wound, defined as 100% re-epithelialization as determined by the Investigator.      Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue     Based Product (HCT/P) under Title 21 CFR Part 1271.   "
128976|NCT01596907|"     Purpose is to determine the effect of ephedrine and caffeine, on metabolic rate and weight     loss after bariatric surgery. Approximately 40% of patients struggle with their weight loss     rate, or metabolic rate, after bariatric surgery, and at least 30% previously had or develop     a low metabolic rate after surgery. Metabolic rate is the speed at which calories are burned.     The fewer the calories eaten and the more calories burned, the more rapidly weight is lost.     It is possible that despite a very low calorie intake following bariatric surgery metabolic     rate will decrease so much so that weight does not decrease even if intake is reduced to 1000     calories per day. Ephedrine is a medicine used commonly to treat asthma, difficulty     breathing, and wheezing. However, 40 years ago it was reported in scientific studies that     ephedrine increases weight loss in patients on low calorie diets by increase the amount of     calories that are burned. Combining caffeine with ephedrine makes ephedrine work more     efficiently (more weight loss over time). Many studies show the effect of ephedrine on weight     loss that began in 1974 with patients on food diets. Ephedrine used in various strengths and     with a number of different combinations has shown to be effective and safe, especially when     directed by a physician. There is only one study where ephedrine has been used in patients     after bariatric surgery. In that study, both the patient and medical staff knew they were     taking ephedrine (i.e., they were not blinded). The patients who were not losing weight or     had measured low metabolic rates were treated with ephedrine. The patients taking ephedrine     lost more weight after surgery than those not taking ephedrine. While this is a significant     finding, the study was not designed to be the best test of the effects of ephedrine. The best     test is where neither the patients nor the medical staff know if the patient is taking the     active drug (double blind). All patients enrolled into the Research Study will receive     capsules that contain either ephedrine and caffeine (the active drug) or identical capsules     with no active ingredient (called a placebo). Neither group of patients will know which set     of capsules they receive. The expected duration of treatment in the Study is 7 months from     the day of surgery. This is a single site study. All patients will have their gastric bypass     performed through Oregon Weight Loss Surgery at Legacy Good Samaritan Hospital. The     investigators expect to study 200 patients with 100 receiving the study drugs (ephedrine and     caffeine in a capsule) and 100 receiving placebo (inactive ingredients in an identical     capsule) over approximately 6 months.   "
128977|NCT01596894|"     The purpose of this study is to evaluate effectiveness of 2 months antibiotic course of     Azithromycin combined with Metronidazole compared with 2 months antibiotic course of     Metronidazole alone.   "
128978|NCT01596881|"     Recent studies have shown that people with multiple sclerosis (MS) who also have diseases     related to vascular health such as high cholesterol, high blood pressure, diabetes,     cardiovascular disease, and others, may end up more disabled than people with MS who don't     have those diseases. This has led to a growing interest in the role of vascular diseases in     MS since they may provide another avenue of MS treatment. Some also think that vascular     disease may even be a cause of MS. The back of the eye, the retina, is well-suited to     studying vascular diseases as blood vessels can be seen even on routine examination of the     eye by eye doctors. These specialists are used to seeing changes in retinal blood vessels due     to diseases known to affect the eyes such as glaucoma and diabetes. Sophisticated techniques     for examining the retina allow for not only visualization of blood vessels, but the rate of     blood flow through the blood vessels as well. These blood flow changes are thought to come     before changes in what the blood vessels look like, and so may be able to detect problems     even earlier than routine examination of the retina by eye doctors. Retinal blood flow has     never been carefully studied in MS. Given that MS affects the retina due to the late effects     of inflammation of the optic nerve, or optic neuritis, the investigators expect to see     altered blood flow in the retinal blood vessels of people with MS compared to healthy control     subjects. If so, the investigators can then use retinal blood flow as a way to measure     therapies that target vascular diseases in the MS population and determine if those therapies     can alter the course of disease.   "
128979|NCT01596868|"     The present study is a randomized, control, phase II study of locally advanced nasopharyngeal     carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin regimen (GP) or     Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by concurrent     chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal carcinoma (NPC).     The effectiveness, side effects and quality of life will be evaluated according to Standard     WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H&N35 questionnaire.   "
128980|NCT01596855|"     The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining     and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on     maintenance hemodialysis and receiving epoetin alfa.   "
128981|NCT01596842|"     Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1,     25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high     dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D     concentrations were significantly increased after 3 months of omega-3 FA supplementation     compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients.     In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D     supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to     25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or     deficient 25-hydroxyvitamin D levels.   "
128982|NCT01596829|"     Antibiotic treatment disturbs the balance of the intestinal microbiota and predisposes to     antibiotic associated diarrhea. Previous studies have shown that the risk of developing     diarrhea during a course of antibiotics may be reduced by simultaneous consumption of     probiotics. The aim of the present study is to assess the effect of a probiotic formula     containing four strains on reducing the risk of antibiotic associated diarrhea.   "
128983|NCT01596816|"     The aim of this study is to assess the safety of hypofractionated stereotactic boost     radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).   "
128985|NCT01596790|"     Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During     these last years, many new chemotherapies and targeted therapies have been developed     improving significantly the overall survival of patients. However, the choice of the     therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of     their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor of     non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers to     propose the best personalized 1rst line therapeutic sequence. One idea would be to enumerate     and characterize the circulating tumor cells (CTC) which, as it has been described in a     recent study realized by Cohen et al. in patients with metastatic colorectal cancer, would     give us an early evaluation of the therapeutic efficiency. In this context, the investigators     have developed an innovative technology, the EPISPOT assay (patent of the University Medical     Center of Montpellier), that allows the detection & characterization of viable CTC in the     peripheral blood. The EPISPOT technology has been already evaluated in the breast and     prostate cancer. Thus, the investigators would like to perform a prospective study on a     cohort of patients with metastatic colorectal cancer to confirm, with this technology, the     predictive value of CTC count for the efficacy of the treatment.   "
128986|NCT01596777|"     The purpose of this study is to describe the effects of methylnaltrexone in preventing     loperamide-induced delay of the oro-cecal and whole-gut transit time and measure     pharmacokinetics of methylnaltrexone after subcutaneous and oral administration of immediate     release and extended release capsules.   "
128987|NCT01596764|"     The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in     preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to     measure pharmacokinetics of methylnaltrexone and naloxone-3-glucuronide after oral     administration of methylnaltrexone and naloxone.   "
128988|NCT01596751|"     The purpose of the Phase 1b portion of the study is to determine the best dose of PLX3397     when given in combination with standard dose eribulin (Halaven™). The purpose of the Phase 2     portion of the study is to find out what effects, good and/or bad, these drugs have on     patients and their metastatic breast cancer.   "
128989|NCT01596738|"     The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a     standard management strategy for patients with acute coronary syndrome. On this background,     an increasing percentage of patients presenting for surgical coronary revascularization is     the subject to irreversible platelet inhibition.      Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for     aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB     activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition     of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis     after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and     inhibits fibrinolysis.      Many studies and meta-analyses have shown a reduction in postoperative bleeding and     transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery.     Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few     studies specify the time between the last clopidogrel ingestion and surgery.Several studies     were keen on the blood loss and allogeneic transfusion in patients who received their last     clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the     secession of aprotinin and the increasing proportion of patients with persistence on     clopidogrel until their surgery, evolutional work is expected, especially in the eastern     population.      The purpose of this study is to assess the effect of tranexamic acid in patients with     clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis is     that tranexamic acid would reduce bleeding and transfusion requirements in this specific     population of patients.   "
128990|NCT01596725|"     The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian     flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down     into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test     article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment     following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts     of the study.   "
128991|NCT01596712|"     This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and     immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the     eligibility of Japanese patients in subsequent clinical studies.   "
128992|NCT01596699|"     The purpose of this study is to find out what effects, good and/or bad, the addition of     clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning     treatment has. The study will also look at what causes some people to have high drug levels     of these medications in their body compared to other people that may have low drug levels     even if they all receive the same dose of medication.   "
128993|NCT01596686|"     The investigators intend to study the impact of two different preparation regimens for     colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient     tolerability.   "
128994|NCT01596673|"     The purpose of this study is to assess the relative abuse potential of the hydrocodone     bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.   "
128995|NCT01596660|"     The ambulatory management after laparoscopic hysterectomy is a reality in our service, where     90% of hysterectomies are laparoscopically done and 80% of these are managed on an ambulatory     basis with shorter hospital stay ;less than 12 hours. (OALOS 9.41 + / - (1.79) range from 5     to 12 hours and POLE 5.38 + / - (1.8) range from 2 to 9 hours)      So far the immediate analgesic management has been made systemically, and the satisfaction     reported by patients was high, even though some patients require longer stay in recovery and     need higher doses of analgesics before their discharge criteria, allowing an optimal     ambulatory management.      There are several treatment options that theoretically could be used but the results have     been variable and have failed to demonstrate the expected benefit.      The Transversus Abdominis Plane Block consists in the deposition of local anesthetic in the     plane between the internal oblique and transverse abdominal, looking to infiltrate the spinal     nerves at this level, so the innervation to the skin, muscles and the parietal peritoneum     will be interrupted. The TAP Block was first described in 2001 , based on anatomy marks     techniques of the peripheral nerves and was developed and evaluated later by McDonnell et al.   "
128996|NCT01596647|"     This is a multi-center, open-label, phase I study to assess the effects of dovitinib (TKI258)     on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and midazolam in     patients with advanced solid tumors, excluding breast cancer. The aim of this study is to     evaluate the potential effect of dovitinib (TKI258) on the metabolism of the probe drugs     caffeine, diclofenac, omeprazole and midazolam, which are metabolized by CYP1A2, CYP2C9,     CYP2C19 and CYP3A4 respectively (Cytochrome P450 isoenzyme), comparing the single-dose     pharmacokinetics (AUCtlast, AUCinf and Cmax parameters) of each of the individual probe drug     co-administered with and without multiple dose of dovitinib (TKI258) 500 mg under a 5 days on     / 2 days off dose schedule. The study foresees two treatment phases: DDI (drug-drug     interaction) followed by post-DDI. During the DDI phase patients receive treatment with the     probe drug cocktail and dovitinib (TKI258). During the post-DDI phase patients may continue     to receive treatment with dovitinib (TKI258) until disease progression (assessed by RECIST     1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other     reason.   "
128997|NCT01596634|"     The purpose of this research study is to determine if using a lactoferrin supplement will     improve taste perception. Lactoferrin is a type of protein that is naturally produced in the     body and is commonly found in saliva.   "
128998|NCT01596621|"     The primary objective of the study is to determine the overall response rate (ORR), which     includes complete response (CR) and partial response (PR), to bendamustine treatment in     patients with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a     rituximab-containing therapy.   "
128999|NCT01596608|"     Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and     is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive     disorder (OCD). However, its use is limited by significant adverse effects on memory and     cognition. In addition, ECT cannot be precisely targeted, since it relies on unpredictable     pathways of electrical conduction through the brain. Magnetic seizure therapy (MST) is     currently under investigation as a targetable, cognition-sparing alternative to ECT. MST uses     magnetic fields rather than electrical stimuli for seizure induction, dramatically reducing     the passage of induced current through undesired brain regions. 10 years of experimental     studies have established the safety of MST in animal and human subjects. This pilot study     will investigate whether MST has similar efficacy to ECT, with fewer cognitive side effects,     in patients with severe depression, schizophrenia, and OCD.   "
129000|NCT01596595|"     Post-approval studies of implanted leads provide an opportunity to observe and assess patient     outcomes and technology performance in a real-world setting. The goal of the study is to     evaluate, document and report on the appropriate clinical performance, long-term reliability     and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the     pulse generator 4-SITE Header.   "
129001|NCT01596582|"     Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal     cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel     computer-based decision aid facilitates several components of SDM from both the patient and     provider perspective, there is a reluctance among providers to acquiesce to patient     preferences for a particular screening strategy when its differs from their own. The overall     objective of this study is to assess whether risk stratification for advanced colorectal     neoplasia influences clinical decision-making related to screening test selection and     adherence within a SDM framework. Eligible subjects will be randomized to either an     experimental arm, in which they will be asked to complete a 6-item risk assessment     questionnaire known as the Advanced Colorectal Neoplasia Index [ACNI] after reviewing a     web-based decision aid, or a control arm, in which they will only review the decision aid.     Both interventions will take place just before a prearranged office visit with their     provider. The primary outcome will be screening test ordered; secondary outcomes will include     test completion rates, concordance between test preference and test ordered,, patient     satisfaction with decision-making process, screening intentions, 6-month test completion     rates and provider satisfaction. Outcomes will be evaluated using computerized tracking     systems or validated instruments.   "
129002|NCT01596569|"     This study investigates the efficacy of a novel neurorehabilitation program combining     noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive     therapy, on cognitive function and quality of life in individuals with blast-induced     traumatic brain injury (bTBI).   "
129003|NCT01596556|"     To the best of our knowledge, a possible relation between smoking and heat injuries or heat     intolerance was never scientifically examined, although such a relation is logical according     to the observations that smoking has a thermogenic effect, decreases physical fitness and     affects the body's heat dissipation.16 healthy young male volunteers will participate in the     study, 8 smokers and 8 non-smokers. They will arrive to our lab four or six times. They will     perform VO2 test and heat tolerance test (HTT) in different conditions.   "
129004|NCT01596543|"     The purpose of the present study is to evaluate the effect of partial and complete sleep     deprivation on exercise heat tolerance. Twelve healthy young male volunteers will participate     in the study. They will arrive to our lab four times, in each visit the will undergo VO2 test     and Heat Tolerance Test (HTT) after sleeping different amount of hours.   "
129005|NCT01596530|"     To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours   "
129006|NCT01596517|"     The purpose of this study is to investigate the efficacy and effectiveness of peginterferon     alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.   "
129027|NCT01596244|"     The purpose of the study is to provide participants in economically depressed areas of Jordan     essential knowledge, practical skills, and intimate support groups—called microclinics—for     managing their diabetes. Microclinics consist of 2-8 individuals from pre-existing social     networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in     ongoing education and medical monitoring from local health care professionals, learning and     practicing diabetes management strategies, sharing much-needed medical supplies, and     exchanging social support in the form of regular micro-clinic meetings.   "
129028|NCT01596231|"     This is a study designed to test whether a single administration of kudzu extract (2 mg) will     significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session     when given as pretreatment 2 ½ hours before the drinking session.   "
129007|NCT01596504|"     Primary Objective:      - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily     (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma     glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after     a standardized breakfast at the end of a 8-week treatment period in participants with type 2     diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).      Secondary Objectives:        -  To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8          mg QD after an 8-week treatment period in participants with T2DM not adequately          controlled with insulin glargine (± metformin) on:             -  Post-prandial C-peptide, glucagon and appetite perceptions after a standardized               breakfast,             -  Appetite perceptions after standardized dinner,             -  Gastric emptying after a standardized labelled test meal,             -  Fasting plasma glucose, 24-hour plasma glucose profile,             -  Glycosylated hemoglobin (HbA1c),             -  Insulin glargine dose,             -  7-point self monitored plasma glucose (SMPG),             -  Body weight and waist circumference,             -  24-hour heart rate and blood pressure,        -  To assess lixisenatide and liraglutide safety and tolerability as add on treatment to          insulin glargine (± metformin).   "
129008|NCT01596491|"     The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use     of capsaicin on skin.      The investigators first experiences with capsaicin in patients with peripheral nerve injury     showed changes in the sensibility, which achieved its maximal extent after four weeks and was     regressive, but not completely abolished 1,5 months after application.      In this study the investigators hope to specify, how long and in which way exactly this     changes in sensibility appear.   "
129009|NCT01596478|"     The efficacy of psychosocial treatments for PG, including cognitive-behaviour therapy (CBT)     and motivational interviewing (MI) approaches, has been supported in a handful of clinical     trials. Indeed, there is more evidence supporting these two approaches than for any other     psychosocial treatment for problem gambling. However, while efficacy studies have been     conducted, few studies have examined the effectiveness of behavioural treatment in     community-based gambling treatment settings. That is to say, the investigators have a good     idea of what works in a laboratory setting (i.e., university research settings), but the     investigators have no research assessing the transfer of evidence-based treatments for     problem gambling to community care. Efficacy studies provide substantially less information     about the actual utility of treatments than do effectiveness trials because the way in which     treatment is actually provided in the field (with flexibility in terms of time-frame and     technique and the tendency to address co-occurring problems) is different from the much more     single-focused (on gambling) way it is conducted in laboratory settings. The proposed study     is designed to address this significant gap in the research literature. The investigators     propose to conduct a treatment effectiveness trial examining a combined cognitive     motivational behavior therapy (CMBT) delivered by community-based problem gambling treatment     providers, compared with treatment as usual (TAU).   "
129010|NCT01596465|"     Our objective was to test two educational interventions for teaching cardiac auscultation:     self-directed learning using portable audio files versus a single, massed multimedia lecture     intervention similar to current best practice, to determine which would most effectively     increase recognition of common cardiac sounds by physicians. The investigators hypothesized     that doctors learning on their own time could better improve their skills.   "
129011|NCT01596452|"     Modern anti-cancer treatments are focused on development of molecular based therapies i.e.     specific treatments targeted against underlying biological processes. There is still much to     learn about the biology of cancer, especially in tumours such as colorectal and lung cancer     where it is likely multiple heterogenous signaling pathways are responsible for progression     of disease. This project aims to evaluate circulating tumour cells (CTCs) as a surrogate     biomarker for tumour characteristics and to determine how they may used to identify new     targets for therapeutic agents. Their use could be applied to diagnosis of cancer, prediction     of response to therapies and prognosis, ultimately across a broad range of tumour types.     Currently the only way to investigate molecular features of a cancer is through procurement     of an invasive tumour biopsy that is often difficult to obtain, often results in insufficient     material and is unpleasant for the patient. A blood-based test would provide a much more     practical and patient friendly alternative. The enumeration and molecular characterisation of     CTCs has the novel potential of being a virtual biopsy of the tumour and offers the     opportunity for immediate therapeutic decisions (eg. if the tumour develops a therapy     resistant genotype while on treatment). CTCs have been known to circulate in bloodstream of     cancer patients for many years and are known to lead to cancer metastases. They have been     very difficult to detect, up until recently, due to the complexity of the metastatic process     and detecting relatively small numbers of CTCs amongst billions of red and white blood cells.     However, technology has moved on dramatically in the last few years. The FDA approved     CellSearch platform (Veridex, NJ) can isolate and enumerate CTCs based on the immunomagnetic     capture of EpCAM (epithelial cell adhesion molecule) positive cells. Several studies have     recently demonstrated the value of CTC enumeration in reflecting prognosis and predicting     early response to systemic chemotherapy. For example, in a study comprising 456 patients with     metastatic colorectal cancer starting a new line of therapy, patients with =3 CTCs per 7.5 ml     blood at baseline had shorter progression free survival (PFS) and overall survival (OS)     compared to those patients with < 3CTCs at baseline (PFS 4.5 versus 7.9 months P=0.0001; OS     8.5 versus 19.1 months P=0.0000 respectively). Overall survival for patients converting to or     maintaining CTCs =3 within a few weeks of commencing systemic therapy remained worse than for     those patients maintaining CTC counts < 3 per 7.5ml blood. Similar results have been reported     in patients with breast and hormone refractory prostate cancer (HRPC). These studies have led     to FDA approval of the CellSearch system as an adjunct to monitoring patients with these 3     tumour types. The CellSearch platform, however, does not allow for the downstream DNA     analysis of captured cells and the ferroparticle-coated CTCs are non-viable. Furthermore,     this platform is a multi-machine, multi-kit system that is laborious (typical 3-7 days     turnover time), expensive (USD 650), and subject to operator variance. In this protocol, the     investigators propose for the first time, an automated, fully quantitative system for     isolation and enrichment of CTCs. The key differentiating feature of our novel CMOS system is     the electrochemical identification and counting of tumour cells using a high density     electrode array with associated electronics for addressing the electrodes. This leads to a     standardized assay for tumour cells with a shorter turnover time and without the need of a     skilled operator. This system also holds the potential for allowing the molecular     characterization of CTCs. This study aims to enumerate CTCs using a novel CMOS technology in     patients with metastatic cancer who are scheduled to receive palliative chemotherapy, and to     correlate CTC number with clinical outcome. In Part I of the study, the investigators will     recruit 10 patients with metastatic NSCLC and 10 patients with metastatic CRC in order to     assess the feasibility of CTC enumeration in patients. In particular, the investigators aim     to establish whether CTCs are detectable using the novel CMOS technology in patients with     metastatic cancer. In Part II of the study, the investigators will recruit 21 patients with     metastatic NSCLC and 89 patients with metastatic CRC in order to compare CTC counts as     determined by the CMOS technology with CTC counts as determined by the CellSearch platform.     Blood samples will be collected at a single time point prior to the start of palliative     chemotherapy. CTC numbers will be correlated with clinical outcome in all evaluable patients.      The investigators hypothesize that CTC enumeration by a novel CMOS technology is non-inferior     to CTC enumeration by the CellSearch platform in patients with advanced solid malignancies.   "
129012|NCT01596439|"     The primary objective of this prospective pilot study is to examine the variation of     cognitive function at various time-points in stage I-III breast cancer patients who have     undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal     therapy) and compare this to a group of healthy controls to evaluate if there is a     difference. All randomized patients and their respective controls would be required to     complete the computerized neuropsychological assessment CANTAB at certain time-points.These     patients and controls would also be given on the same day as CANTAB testing, a set of     questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or     menopausal symptoms which may also have an effect on cognition. Subjective assessment of     cognitive function will rely on self-reporting by study participants using a validated     questionnaire.The potential risks to subjects are minimal, as this is a study without any     intervention regarding the medical management of patients. By participating in this study,     subjects will be helping in the aim of determining if there is cognitive impairment     post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes     with time. This will consequentially play an important role with regard to patient knowledge.     Furthermore, if chemotherapy is shown to be associated with cognitive impairment, further     studies can be carried out to determine the exact pathophysiology behind this phenomenon.     This will allow for sensitive and timely detection of cognitive dysfunction in patients who     have received chemotherapy and/or anti-hormonal therapy, and subsequently open the avenue for     research in preventing or alleviating this phenomenon. This is crucial in improving patients'     quality of life, social and occupational performance.      The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy     and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive     impairment.   "
129013|NCT01596426|"     The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5     years.   "
129014|NCT01596413|"     The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12     years.   "
129015|NCT01596400|"     The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17     years.   "
129016|NCT01596387|"     The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model     to administer propofol in obese patients.      Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing     weight and that mathematical models to administer drugs in obese patients can be developed to     accurately predict dose schemes in this population.   "
129039|NCT01596088|"     The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in     the treatment of accidental extravasation of anthracycline anti-cancer agents.   "
129040|NCT01596075|"     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing     allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the     incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from     HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched     unrelated transplants. More effective prevention and treatment strategies are needed.      The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in     animal models of various inflammatory diseases including multiple sclerosis, inflammatory     bowel disease and rheumatoid arthritis.      Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and     immunosuppressive effects.      As such, it may be effective for both prevention and treatment of acute GVHD after allogeneic     stem cell transplantation.   "
129017|NCT01596374|"     Alterations involving the ROS (v-ros UR2 sarcoma virus oncogene homolog 1) gene such as     mutations, overexpression and gene rearrangements has been implicated in carcinogenesis and     has been demonstrated to be a relevant target for ALK inhibitors. While emerging reports have     demonstrated the role of ROS rearrangement in non-small cell lung cancer and     cholangiocarcinoma, the functional significance of ROS dysregulation in solid tumors remain     largely unstudied. The investigators aims are: (1) To characterize the frequency of ROS gene     fusion, ROS protein overexpression and ROS gene mutations in cell lines and tumors from     patients with hepatocellular carcinoma, colorectal, gastric, breast, ovarian,     cholangiocarcinoma and non-small cell lung cancer, (2) To identify novel ROS gene variants in     human solid tumors harboring ROS aberrations using next generation sequencing (NGS), (3) To     determine the functional relevance of novel ROS gene variants identified with NGS, (4) To     characterize the sensitivity of cells with functionally relevant ROS aberrations using ROS     tyrosine kinase inhibitors. ROS fusions and protein overexpression will be screened in a     panel of cell lines and primary tumors using Fluorescence In-situ Hybridization and     immunohistochemistry respectively. Targeted next-generation sequencing will be applied to     identify ROS variants in matching cancer types demonstrating high levels of gene fusion and     protein overexpression. Functional characterization of novel ROS variants will be performed     by silencing (shRNA) and overexpressing candidate cell lines with the respective ROS     mutations/fusions, and evaluating their effects on biological functions including cell     proliferation, migration, invasion and apoptosis, as well as sensitivity against ROS/ALK     inhibitors. The investigators anticipate findings from this study will improve the     investigators understanding of aberrant ROS signaling in an expanded group of cancer types,     and potentially identifying a larger group of cancer patients that will benefit from ROS     targeted therapy.      Further insight of the role of ROS receptor tyrosine kinase will confirm it as a therapeutic     target in human solid tumors and hence expand the indication of crizotinib and other dual     ALK/ ROS inhibitors. Furthermore, given the rarity of ROS fusion receptor tyrosine kinase in     reported cancers, defining the epidemiology of ROS aberrations in other unreported cancers     harboring ROS pathway activation is essential to properly design future clinical trials of     ROS inhibitors. The validation of ROS receptor tyrosine kinase will also provide a new     therapeutic target in the treatment of cancer and expand the role of novel targeted agents.     Findings from this study will further the investigators knowledge on the oncogenic functions     of the ROS and the application of ROS inhibitors in an extended group of solid tumors.   "
129018|NCT01596361|"     Interethnic variability in chemotherapy response is becoming increasingly evident, making     approaches for customizing chemotherapy treatment to different ethnic populations desirable.     At the same time, significant genetic variation has also been observed between ethnic groups,     including many germline and somatic pharmacogenetic variants involved in chemotherapy     pharmacology. Recently, based on meta-analyses of studies on germline pharmacogenetic variant     frequencies and clinical trials, the investigators found that chemotherapy outcomes between     Asians and Caucasians colorectal cancer (CRC) patients could potentially be inferred from the     frequencies of variants between the ethnic groups and their respective biological functions.     In this study, the investigators seek to further clarify the validity of using     pharmacogenetic variants to customize chemotherapy between ethnicities through the following     specific aims: (1) To verify the differences observed in the frequency of germline     pharmacogenetic variants related to chemotherapy between Asian and Caucasian CRC patients,     (2) To test whether variations in the frequency of somatic pharmacogenetic gene mutations     between Asian and Caucasian CRC patients could be used to infer differences in clinical     outcomes between the two ethnicities. (3) (4) For Aim 1, DNA samples from approximately 1000     Asian and Caucasian CRC patients each will be analyzed for the frequency of a panel of     germline pharmacogenetic variants identified in our meta-analyses using high-throughput     methodology. For Aim 2, meta-analyses will be performed on pharmacogenetic studies and     clinical trials to establish the relative frequencies of somatic variants and clinical     outcomes in Asian and Caucasian CRC patients. These frequencies will be verified on the same     series of DNA samples used in Aim 1. The clinical outcomes inferred from the frequency     differences and biological functions will then be compared to those summarized from clinical     trials. This data could provide a basis for developing a rational approach to customizing     chemotherapy in non-Caucasian populations and improve assessment of drug feasibility in     different ethnic populations.If validated, this working hypothesis would be of high clinical     interest, giving the opportunity to use this as a DNA prognosis biomarker in CRC.      Pharmacogenetic frequencies could be a potentially useful approach for predicting likely     chemotherapy outcomes in non-Caucasian populations   "
129019|NCT01596348|"     The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.   "
129020|NCT01596335|"     The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with     a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with     Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The     pharmacokinetics of TA-650 is also examined.   "
129021|NCT01596322|"     Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.   "
129022|NCT01596309|"     Obesity prevalence in elderly populations has increased in the last years, and the reduction     of overweight and obesity is a priority target in populations of all age ranges worldwide.     Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic     functions may be compromised, and therefore there is a risk of developing comorbidities such     as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context,     plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols     have been shown to have an important antioxidant effect. Scientific evidence based on     epidemiological studies suggest that flavonoids from the diet play an important role on the     prevention of cardiovascular disease. Cocoa and related products are an important source of     flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa     consumption are related to the ability for improving lipid profile and insulin sensitivity,     reducing blood pressure, platelet activity and improving endothelial dysfunction. Some     studies have also shown an improvement of inflammatory conditions, mainly due to the capacity     of the polyphenols contained to modify cellular transcription, and the secretion of     proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic     strains. Therefore, the hypothesis of this study is that the consumption of cocoa     extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight     and to improve cardiovascular risk factors compared to the same diet with standard prepared     meals.   "
129023|NCT01596296|"     The purpose of this study is to assess the effectiveness and safety of transcervical foley     catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening and     labor induction in term parous women with unfavorable cervix.   "
129024|NCT01596283|"     The purpose of this study is to help us learn what is the best amount of fluid to administer     to patients during liver surgery. Patients will receive either an amount for this surgery     based on weight, blood pressure, heart rate and urine output or an amount guided by a     computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The     FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on     real time information like blood pressure, pulse and the ability of the heart and blood     vessels to maintain normal vital signs.   "
129025|NCT01596270|"     Primary Objective:      - To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a     day in patients with solid tumors or lymphoma.      Secondary Objectives:        -  To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or          twice a day in patients with solid tumors or lymphoma.        -  To evaluate the effect of food on blood levels of SAR245409 after administration of          SAR245409 tablets in patients with solid tumors or lymphoma.        -  To evaluate the effect of SAR245409 on the body after administration of SAR245409          tablets once or twice a day in patients with solid tumors or lymphoma.        -  To obtain information on how SAR245409 administered once or twice a day to patients with          solid tumors or lymphoma affect disease symptoms and study treatment side effects as          reported by the patients on a questionnaire.        -  To explore the antitumor activity of SAR245409 tablets administered once or twice a day          to patients with solid tumors or lymphoma.   "
129534|NCT01589614|"     The purpose of this study is to investigate the effect of co-administration with erythromycin     on the time course of PH-797804 concentration in the blood following dosing by oral immediate     release tablet formulation.   "
129029|NCT01596218|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational drug. Phase I studies also try to define the appropriate dose of the     investigational drug to use for further studies. Investigational means that the drug is     still being studied and that research doctors are trying to find out more about it. It also     means that the FDA has not approved brentuximab vedotin for the treatment of GVHD.      Currently, corticosteroids are the standard/first line of treatment for people with GVHD.     However, some patients do not achieve a good response with steroids and other experience     flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a     weakening of the immune system. For this reason, there have been increased attempts by     researchers to find other options for the treatment of Graft vs. Host Disease.      Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of     cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of     protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target     CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but     results from other research studies show that it could help slow the growth of your disease.      In this research study, we are trying to determine the safest dose of brentuximab vedotin     that can be given to patients with GVHD.   "
129030|NCT01596205|"     Previous studies about cognitive intervention targeting older adults revealed that cognitive     training had effects on the improvement of cognitive function.However, researches are rare     that investigated direct changes of brain structures after cognitive training.      The advanced scientific technique allowed us to develop service robots designed to assist     human work, which can be important with an increase in the aging population and high costs of     elderly care. In this regard, the investigators considered robots for elderly's cognitive     training and developed 17 cognitive programs in collaboration with Center for Intelligent     Robotics at Korea Institute of Science and Technology.      The purposes of this study were to demonstrate the effects of the investigators newly     developed robot assisted group cognitive training programs on the brain in older adults and     to identify whether they can help to improve cognitive function or mood in the elderly     compared to the conventional cognitive training or control group that were not involved in     any cognitive training.   "
129031|NCT01596192|"     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing     allogeneic hematopoietic cell transplantation. 18F-FDG PET/CT (2-[fluorine-18]     fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that     allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake     is caused by increased local metabolic activity. In this study, we aim to evaluate and     characterize the correlation between CT-PET findings in patients suspected to have acute     GVHD, and the disease course.   "
129032|NCT01596179|"     The purpose of the Technology Enhanced Nurse Navigator Trial (TENN) Trial is to find the best     way to provide breast cancer patients with information through a computer connected to the     internet. The study will determine if giving information during treatment may help patients     cope better with their treatment. The hypothesis is that participants assigned to receive     Technology-Enhanced Nurse-directed Navigation will be more likely to adhere to treatment     regimens and have improved symptom management than women who have access to the education     portal only.   "
129033|NCT01596166|"     Migraine headaches are a common problem for children. When treatment at home fails, children     may benefit from intravenous treatment administered in a hospital setting like the Emergency     Department. Most treatments used however have only been tested in adults and the best     treatment strategy for children is not always clear. The combination of more than one     medication is frequently prescribed in Canadian Emergency Departments. The purpose of this     study is to investigate whether the combination of ketorolac (an anti-inflammatory pain     medication) and metoclopramide (an anti-nauseant that may also relieve migraine headaches) is     better than metoclopramide by itself.   "
129034|NCT01596153|"     The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx) versus     placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or     antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.   "
129035|NCT01596140|"     The goal of this clinical research study is to find the highest tolerable dose of vemurafenib     that can be given in combination with either everolimus or temsirolimus. The safety of these     drug combinations will also be studied.      Vemurafenib is designed to block BRAF inside the cancer cells, which is a mutation that is     involved in cancer cell growth.      Temsirolimus and everolimus are designed to block the growth of cancer cells, which may cause     cancer cells to die.   "
129036|NCT01596127|"     The goal of this clinical research study is to learn about the safety and effectiveness of     rituximab given by spinal tap in patients with lymphoid malignancies involving the central     nervous system.      A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is     collected by inserting a needle into the lower back. The affected area is numbed with local     anesthetic during the procedure. It will also be used to give chemotherapy in this study.      Rituximab is designed to bind to a protein, called CD20, that is on the surface of the     leukemia cells. This may cause the leukemia cells to die.   "
129037|NCT01596114|"     The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of     molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase     Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response     (MMR) or better after stopping TKI therapy.      Secondary goals include:        -  Identification of clinical and biological factors affecting the persistence of complete          molecular remission after stopping TKI (e.g. level of Complete molecular remission          (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)        -  Evaluation of quality of life (QoL) in patients stopping TKI        -  Evaluation of medico-economic impact of stopping TKI        -  Estimating the number of patients in CMR who are eligible for stopping TKI therapy by          setting up a screening log        -  Time to recovery of CMR There will be no randomised comparison. Based on the experience          of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month          molecular-relapse-free survival probability of at least 40%. An interim analysis will be          performed after a pilot phase where 200 patients have been observed for at least six          months. Formally, it is planned to test the null hypothesis H0: Six-month molecular          relapse-free survival probability P ≤ 40% against the alternative hypothesis H1:          Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML          patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log          reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by          a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be          performed during 3 years: Associated scientific projects are performed. Recruitment          period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500   "
129038|NCT01596101|"     Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children     admitted to the burn intensive care unit.   "
129041|NCT01596062|"     The aims of this study are to extensively study the levels of CD25-Receptors saturation and     expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to     demonstrate that saturation and expression vary according to the dose of Simulect® given),     and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the     data with Neoral®.      It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks     post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in     combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin     inhibitor free immunosuppressant therapy.   "
129042|NCT01596049|"     This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical     repair of unilateral inguinal hernia, which is becoming the new standard of care in open     surgical repair of inguinal hernia.      The study design is interventional, enrolling 300 patients above 18 years of age, admitted     for elective repair in the surgical department of Rambam Medical Health Care Campus, an     academic medical center.      The study will assess several outcomes including post-surgical pain, recurrence, quality of     life and post surgical complications (e.g. wound infection, the formation of hematoma or     seroma, etc).   "
129043|NCT01596036|"     The purpose of this study is to test if an early appointment (within 10 days) when compared     to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation     orientation and subsequent enrollment into cardiac rehabilitation.   "
129044|NCT01596023|"     The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA     clearance for use in patients with respiratory difficulty. The investigators believe that the     Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added     tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe     chronic obstructive lung disease (COPD) to assess their work of breathing while using the     NIOV system as measured by esophageal and stomach pressures.   "
129045|NCT01596010|"     This trial is conducted in Europe. The aim of this trial is to investigate whether a     reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of     Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.   "
129046|NCT01595997|"     The overall purpose of this study is to support the development of a DLX105 topical     formulation for the indication mild to moderate psoriasis vulgaris.   "
129047|NCT01595984|"     The main objective of this protocol is to compare the impact on renal function of two     different immunosuppressive regimens in patients with de novo renal transplant.      Renal function will be accurately evaluated by measuring the clearance of iohexol.      The protocol will also evaluate the efficacy and safety in a short term of these two     different immunosuppressive regimens.   "
129048|NCT01595971|"     The purpose of this study is to evaluate the effectiveness of multifaceted educational     interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in     teams of the Family Health Strategy and the consequent clinical improvement patients.   "
129049|NCT01595958|"     The investigators hypothesised that cyclosporine A administration at the onset of     cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore,     could prevent the post cardiac arrest syndrome and improve outcomes.   "
129050|NCT01595945|"     Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even     after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is     still unclear. Lower resting metabolic rates were also reported after gastric banding     bariatric surgery but have not yet been investigated in subjects after gastric bypass. The     purpose of this study is to investigate the consequences on resting metabolic rate in     subjects with obesity after moderate caloric restriction or gastric bypass.   "
129051|NCT01595932|"     The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in     pediatric patients with predominant gas-related symptoms.   "
129052|NCT01595919|"     The objective of the current study is to determine the effects of an ad libitum intake of 1%     milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food     intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that     1% milk will reduce food intake and result in better post-meal glycemic response compared to     the other beverages.   "
129053|NCT01595906|"     The use of infantry helmets under heavy heat stress conditions, during physical exertion, may     hinder the body's ability to effectively dissipate heat from the head area, thereby damaging     the soldier's function. Therefore head cooling may potentially enable a longer duration of     activity until reaching fatigue. An improvement in function may also be possible.The purpose     of this research is to determine the extent of the cognitive and physiological strain caused     by wearing a helmet under exertional conditions while exposed to heavy heat stress and to     evaluate the effect of a unique ventilation system connected to the helmet on strain     reduction.   "
129054|NCT01595893|"     Polymorphic light eruption (PLE) is a common photodermatosis with a high prevalence of     approximately 11 to 21% in the population. Similar to lupus erythematosus (LE), an     UV-inducible systemic autoimmune disease, PLE has a female preponderance with a mean onset in     the second to third decade of life. PLE lesions are very itchy and typically appear on     sun-exposed body sites in spring or early summer. The quality of life in patients with PLE is     often severely disturbed, as evidenced by high levels of anxiety and depression. For     prophylaxis besides conventional sunscreens, photo(chemo)therapy is effective in many cases,     when administered over several weeks for hardening in early spring before the first natural     sun exposure takes place. However, because prolonged treatment with UVB and/or     photochemotherapy is potentially carcinogenic, the search for pathogenic mechanisms and new     treatment options in PLE is ongoing. The exact pathogenesis of PLE is currently unknown but     findings suggest an autoimmune-type background with resistance to UV-induced immune     suppression and simultaneous immune reactions against skin photo-neoantigens. The     investigators have recently found that PLE patients had significantly reduced     1,25-(OH)2-vitamin D3 serum levels (13-14ng/ml) compared to the normal population (>30ng/ml).     In addition, the investigators were able to demonstrate in an intra-individual half-body     trial that topical administration of an immunostimulatory 1,25-(OH)2-vitamin-D3 analogue     calcipotriol reduced PLE symptoms in an experimental study. In the proposed randomized     double-blinded placebo-controlled trial the investigators attempt to study the effect of oral     vitamin D3 supplementation (2 x 40.000 IE, given orally two weeks apart) on PLE symptoms.   "
129056|NCT01595867|"     This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study     designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine     sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid     users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be     selected during Part A of the study (Dose Selection Phase). Each subject participated in the     study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to     12 nights.   "
129057|NCT01595854|"     Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new     pharmacodynamic methods   "
129058|NCT01595841|"     Dialysis patients presenting for angioplasty intervention for graft failure will be     randomized to receive either Sirolimus or not receive Sirolimus (standard of care) to assess     the time from primary failure or angioplasty intervention to second or next angioplasty     intervention or graft failure.   "
129059|NCT01595828|"     The purpose of this study is to examine in detail the acute and chronic effects of     pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk     for the premature development of atherosclerosis (CAPITAIN).   "
129060|NCT01595815|"     Artificial oocyte activation with strontium chloride or calcium ionophore improves     fertilization, embryo quality, pregnancy and delivery rate in women who showed complete     fertilization failure or low fertilization rates   "
129061|NCT01595802|"     The purpose of the study is to determine the sensitivity, specificity and predictive values     of the Jan Medical NeuroWave System in detecting moderate and severe vasospasm in comparison     to Trans Cranial Doppler(TCD).   "
129062|NCT01595789|"     The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1     (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints     compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly     diagnosed type 2 diabetes (T2D).      It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients     with T2D will improve beta-cell function, left ventricular ejection fraction (LVEF), heart     rate variability and lower 24h blood pressure among other selected endpoints.      The present study on CAD patients with newly diagnosed T2D will address these selected     endpoints during an investigator initiated, randomized, double blind, crossover,     placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.   "
129063|NCT01595776|"     Aim: to value the safety and efficacy of local intramuscular administration of immunoselected     autologous endothelial progenitor cells in the treatment of critical limb ischemia in     patients without revascularization options.      Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto     transplantation of endothelial progenitor cells.      Secondary goal: to value the efficacy of local administration of autologous endothelial     progenitor cells in the treatment of critical limb ischemia   "
129064|NCT01595763|"     To asses the cost-effectiveness of implementing different diagnostic strategies in patients     with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in     primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care.     To describe the differential diagnosis and the strength of association between each outcome     variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional,     multicentric study.   "
129065|NCT01595750|"     REVASC is a randomized, double-blind, placebo-controlled study which will involve 150     patients with chronic bronchitis and COPD diagnosed cardiovascular disease. The recruitment     period beginimg in the coming weeks, will last nine months. Patients included in the study     will receive treatment for three months with roflumilast 500 mg (75 patients) or placebo (75     patients) in a randomized manner. The CIBERES, as promoter of this study is expected to     release final results for the third quarter of 2013.      Eight centers in Madrid will be involved in this clinical trial: Fundación Jiménez Díaz,     Hospital La Princesa, Hospital Gregorio Maranon Hospital Clinico San Carlos, Hospital La Paz,     Hospital Ramón y Cajal Hospital Doce de Octubre and Hospital Puerta del Hierro.      Roflumilast is a potent phosphodiesterase-4 inhibitor (PDE4). Its clinical efficacy has been     studied in an extensive clinical program involving over 12,000 patients with COPD. In these     studies, roflumilast (in combination with long-acting bronchodilators) reduced the number of     exacerbations and improved lung function, especially in those patients with associated     chronic bronchitis.   "
129066|NCT01595737|"     This study aims to examine the efficacy of levosimendan in terms of reducing postoperative     mortality and severe morbidity in patients undergoing non-emergent surgery for coronary     revascularisation with or without ischaemic mitral regurgitation and who may or may not     require repair or replacement of the mitral valve and have a LVEF < 35%.   "
129067|NCT01595724|"     The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d)     on the Endometriosis related quality of life. These data will be collected using a special     patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to     describe the basic disease status and demographic characteristics of patients searching     treatment by a gynecologist because of their endometriosis. In addition, the study will give     insight into the typical diagnostic measures the physicians in different countries are using     in the field of endometriosis.   "
129068|NCT01595711|"     The skin conductance algesimeter (Pain Monitor™, Med-Storm Innovation AS, NO-0264 Oslo,     Norway)) reflects the sympathetic nervous system by the measurement of the skin conductance     of the palm of the hand. SCA detects nociceptive pain fast and continuously, specific to the     individual, with higher sensitivity and specificity than other available objective methods.      The skin conductance response to a calibrated noxious stimulus varies among patients. It     defines two types of people depending on its magnitude.      The investigators assume that the importance of skin conductance response to a noxious     stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.   "
129100|NCT01595295|"     This registry is set up to collect real-world experience in the management of patients with     myeloid neoplasms, in particularly in patients with MDS, CMML or AML, treated with     hypomethylating agents in Austria and potentially other participating countries. This     registry will collect data in a retrospective as well as in a prospective manner at various     sites. The aim is to gain valuable insights on both efficacy and toxicity of these drugs in a     routine clinical setting in patients with various comorbidities.   "
129069|NCT01595698|"     Schizophrenia is a severe mental illness, of psychosis being the most prevalent in society,     affecting 1% of the population. The treatment of schizophrenia is basically done with     antipsychotic drugs, although other non-pharmacological interventions, such as exercise, a     form of treatment seems to be considered. Among the most recommended exercise for the general     population, the investigators highlight the aerobic and resistance exercises. However, few     studies have reported the positive effect of aerobic exercise in the pathogenesis of     schizophrenia. In relation to resistance exercise, it is unknown if the effect in patients     with the disease, especially when one considers the junction of the two types of exercises in     the same training session (called concurrent training). However, it is known, through     clinical studies and animal models, that exercise modifies the brain improves     neuroplasticity, the mental condition of the individual frames and reverses     neurodegeneration. Associated with improvement in schizophrenia, few clinical trials of     aerobic exercise showed improvement in disease symptoms, reducing anxiety and depression, and     clinical global improvement. The hypothesis is that the types of proposed training, aerobic     training, resistance training and concurrent training can improve clinical symptoms of the     disease, and improve the side effects caused by drugs. It is believed that the clinical     changes are accompanied by increased serum IGF-1 by resistance training and aerobic training     by BDNF.   "
129070|NCT01595685|"     The goal of chronic hepatitis B (CHB) treatment is complete and permanent eradication of     hepatitis B virus (HBV) from patient's body, which is best represented by serum HBsAg loss     accompanied by undetectable serum HBV DNA level.      While the most recently approved nucleos(t)ide analogues (NA) have marked antiviral potency     and can induce HBV DNA undetectability in the majority of patients through prolonged     treatment, NA need to be given long term, almost indefinitely, in most cases because they     suppress HBV DNA only during therapy. For example, even after HBeAg-loss by a potent NA,     suppression of serum HBV DNA to undetectable level is sustained only in about 23%-37% at 24     weeks off treatment. Thus, continuous therapy with NA until HBsAg clearance remains necessary     in a majority of cases.      The recent availability of commercial quantitative assays of serum hepatitis B surface     antigen (HBsAg) has enabled quantitative HBsAg to be used as a biomarker for prognosis and     treatment response in CHB. It has been suggested that HBsAg decline during lamivudine or     entecavir therapy is slower and less pronounced compared to interferon treatment, despite a     higher effect on HBV DNA suppression. Based on HBsAg kinetics, it has been estimated that the     predicted median time to HBsAg loss in patients treated with lamivudine or entecavir is more     than 30 years. Thus, treatment that can induce rapid decline of HBsAg would have clear     advantage in reducing the treatment duration required to achieve HBsAg-loss.      Interestingly, in a recent preliminary study, 24-weeks of treatment with telbivudine has     induced HBsAg decline as comparable to pegylated interferon treatment. Although there has     been no head-to-head trial comparing NAs in inducing HBsAg decline, previous studies     consistently suggested that the decline of HBsAg is greater during telbivudine treatment     compared with lamivudine or entecavir.      Thus, in this clinical trial, the investigators will investigate whether telbivudine is more     effective in inducing HBsAg decline compared with entecavir in HBeAg-positive CHB patients     who have achieved undetectable serum HBV DNA by preceding entecavir treatment.   "
129071|NCT01595672|"     The purpose of this study is to determine the effect and safety of early high-volume     continuous veno-venous hemofiltration for patients with severe acute pancreatitis.   "
129072|NCT01595659|"     Among the many risk factors that contribute to young drivers' crash involvement, two are     critical: peer passenger presence, which is unique to young drivers, and the influence of     alcohol, a universal risk for drivers but one against which young drivers are most     susceptible. Clarification of how passenger presence interacts with alcohol consumption to     increase risk is needed. The impact of experimentally manipulated passenger characteristics     and alcohol quantity on risky driving is observed using driving simulation and a random     assignment experimental design with a sample of 18-19 year old male and female drivers.   "
129073|NCT01595646|"     The study will examine the effects of intranasally administered long-acting insulin detemir     on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment     (aMCI). The rationale for these studies is derived from growing evidence that insulin     contributes to multiple brain functions, and that insulin dysregulation can contribute to AD     pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have     beneficial effects on brain function. Intranasal administration of insulin increases insulin     signaling in the brain without raising peripheral levels and causing hypoglycemia. Insulin     detemir is an insulin analogue that may have better action in brain than other insulin     formulations because of its albumin binding properties. The investigators will test the     therapeutic effects of intranasally-administered insulin detemir in a study in which     participants will receive insulin detemir, regular insulin, or placebo over a four month     period. The investigators will test the hypothesis that insulin and insulin detemir will both     improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that     insulin detemir will have the greatest effect.   "
129074|NCT01595633|"     In Korea, the number of suboptimal responders to rescue combination therapy is also     increasing. As a matter of fact, according to the investigations in Korea, HBV DNA     undetectability at 48 weeks of adefovir and lamivudine combination rescue therapy for     patients with lamivudine resistance was reported to be only 32.4%, which suggested that the     appropriate another rescue therapy might be urgently required. However, there is no promising     oral antiviral agents to control these patients in Asia-Pacific region, where tenofovir is     not widely available. Tenofovir has a higher potent antiviral efficacy and a negligible drug     resistance rate. The switch from adefovir to tenofovir in patients who have insufficient     hepatitis B virus (HBV) suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to increased viral     suppression or more HBeAg loss/seroconversion.      Here, the investigators aimed to conduct a randomized study on evaluating the antiviral     efficacy, safety, and tolerability of switching from adefovir to tenofovir in chronic     hepatitis B patients who have suboptimal response to adefovir-based combination rescue     therapy due to nucleoside analogues Resistance (SATIS study).   "
129075|NCT01595620|"     The purpose of this study is to test the effects of cannabinoids on pain response using a     variety of human experimental pain models.   "
129076|NCT01595607|"     The study will investigate the effect of avocado consumption on markers of vascular health.     Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be     utilized. Participants will either receive a typical American diet, or a modified typical     American diet in which avocado is substituted for foods that contain moderate and high     amounts of saturated fat, to allow the isoenergetic inclusion of avocado.   "
129102|NCT01595269|"     This project addresses the following Null Hypotheses:        1. There will be no difference will be found in the use of the search engine and the          information accessed among the three education modes.        2. There will be no difference in education mode's effect on metabolic control, self-care          management practices, and medical resource utilization.        3. There will be no difference in the economic impact on the health care system based on          differing education modes.   "
129077|NCT01595594|"     The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non     surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will     be selected and divided in two groups. On the treatment stage, the control group (Group C)     will receive standard non surgical periodontal treatment. The Test Group (Group T) will be     treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be     repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish     3 months. The follow-up will be done for 6 months. The clinical parameters measured will be:     plaque index, pocket depth, bleeding on probing, relative clinical insertion level and     suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1,     TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The     investigators expect to find identical or better results for the test group.   "
129078|NCT01595581|"     This study is being done to test whether taking testosterone can prevent loss of muscle mass     and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is     the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential     for the development of male reproductive tissues and promotes increased muscle, bone mass,     and the growth of body hair.      The investigators hope to learn whether testosterone given before and after ACL     reconstructive surgery will increase muscle mass and strength and potentially improve     recovery time following surgery.   "
129079|NCT01595568|"     In adolescents, mental health problems are frequently associated with substance misuse, even     considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to     complicate the patient's treatment and prognosis by increasing, among others, substance use     problems, reckless behaviours, relationships and school problems and suicidal thoughts. It is     therefore critical to invest time and effort into developing an efficient approach to prevent     and reduce substance use problems and offer these children a more global and optimal     treatment.      A brief personality-targeted intervention was developed with students of Canadian and English     high schools based on four personality factors known to be implicated in the vulnerability to     adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative Thinking and Sensation     Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).      By helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural     intervention proved to reduce binge drinking, quantity and frequency of use and substance use     problems (Conrod et al., 2006,2011).      The purpose of this study is to assess the impact of this intervention if combined to a     regular treatment in a youth psychiatric population.      60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be     screened for personality risk with self-report assessments including the Substance Use Risk     Profile Scale. Participants will be randomly assigned to a personality matched     cognitive-behavioural intervention or a no-intervention control.      The main outcome measures of this study are alcohol and illicit drug outcomes. Secondary     measures include mental health symptoms.   "
129080|NCT01595555|"     This research will examine whether an Internet-based mindfulness program for stress     management produced positive outcomes for participants and is technologically feasible   "
129081|NCT01595542|"     The study will evaluate a health services intervention to increase uptake of adolescent     vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five     school health centers by improving the consent process for parents.   "
129082|NCT01595529|"     To determine if halting antimicrobial therapy in subjects who have exhibited clinical     improvement 5 days after starting antibiotic therapy (short course therapy) have the same     failure rate, defined as symptomatic Urinary Tract Infection (UTI) through Test of Cure (TOC)     on Day 11-14, as subjects who continue to take antibiotics for an additional 5 days (standard     course therapy). To determine if short-course therapy compared to standard course therapy     results in similar numbers of children with gastrointestinal colonization of antimicrobial     resistant Escherichia coli (E. coli) and Klebsiella pneumonia (K. pneumoniae).   "
129083|NCT01595516|"     The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult     humans with elevated blood pressure to a greater extent than either metoprolol or placebo.     The investigators further hypothesize that the improvement in the capacity of the vascular     endothelium to release t-PA with nebivolol is mediated, in part, by the compound's     antioxidant properties.   "
129084|NCT01595503|"     Repetitive transcranial magnetic stimulation (rTMS) is a new noninvasive therapy that uses     magnetic energy applied to the scalp to modulate activity in the underlying regions of the     brain. In this study we will examine the efficacy of treating auditory hallucinations in     schizophrenia with rTMS, comparing two methods to target stimulation to a language processing     region of the brain. One method targets the stimulation site using scalp landmarks, while the     other uses functional magnetic resonance imaging (fMRI) combined with a language task.   "
129085|NCT01595490|"     The objective of this study is to determine whether participation in a mind-body skills     program by war-traumatized adolescents in Gaza will result in improvement of posttraumatic     stress symptoms, depression, and levels of aggression compared to a control group.   "
129086|NCT01595477|"     The objective of this study is to determine whether participation in a mind-body skills     program by war-traumatized children in Gaza will result in improvement of posttraumatic     stress symptoms, depression, and decreased hopelessness compared to a control group.   "
129087|NCT01595464|"     The objective of this study is to determine whether participation in a mind-body skills     program by war-traumatized adults in Gaza will result in improvement of posttraumatic stress     symptoms and depression, and will increase posttraumatic growth compared to a control group.   "
129101|NCT01595282|"     The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on     immediate post-procedural pain scores in patients undergoing first trimester suction     curettage with local anesthesia only.      Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an     approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately     after the procedure.      Secondary hypotheses include:        -  Pain scores on the 21-point scale will also be significantly lower in the ketorolac          group immediately after cervical dilation and 15 minutes post-procedure.        -  Fewer patients in the ketorolac group will rate their pain as severe on a subjective          pain rating scale.        -  Patients in the ketorolac group will be more satisfied with their pain control.        -  Side effects will be similar between groups.   "
129088|NCT01595451|"     We are doing this study to investigate the effects of acupuncture on chronic low back pain.     We are interested in learning about brain activity during pain. We plan to look at brain     activity at the beginning and the end of the study, after 6 sessions of acupuncture     treatment. You will be randomly assigned to one of two groups to receive either real or     placebo acupuncture.      Acupuncture has been used for many years to help relieve pain. However, it is not clear how     acupuncture works. Acupuncture may relieve pain by changing activity in the nervous system.     Some studies indicate that acupuncture may relieve the low back pain. However, we need more     research to see how well acupuncture works to relieve pain for people with this condition.      In this study, we will measure your brain activity before and after you do exercises to make     your back pain worse. We will also measure your brain activity while inflating a pressure     cuff device on your lower leg. We will measure this brain activity using a research tool     called functional MRI (fMRI). Functional MRI is a very fast MRI that uses radio waves and a     magnet, and allows the study investigators to look at changes in blood flow to different     parts of the brain when there are changes in brain activity.   "
129089|NCT01595438|"     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to     Doripenem for treating hospitalized patients with complicated urinary tract infections,     including acute pyelonephritis   "
129090|NCT01595425|"     This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC     capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of     these two formulations in healthy male Japanese subjects.   "
129091|NCT01595412|"     Background:      Rectal prolapse (RP) is the descent of the upper rectum and is a common problem in the     western world. Surgery is the only definite treatment and is preferably performed minimally     invasive. High-level prospective studies on treatment strategies for RP currently are lacking     and, thus, no consensus exist regarding the optimal treatment for patients with RP.     Furthermore, remarkable transatlantic differences exist, as in Europe, laparoscopic ventral     rectopexy (LVR) is regarded the treatment of choice, while in the USA Laparoscopic Resection     Rectopexy (LRR) remains the golden standard.      Objective:      To determine the optimal minimally invasive surgical treatment for patients with RP.      Design:      International, prospective, comparative double cohort study. The first cohort will consist of     120 European patients with a RP and will be treated with LVR. Centres in The Netherlands,     Belgium and the UK are enlisted for participation. The second cohort will consist of 120     American patients with a RP, treated with LRR. Several US centres are enlisted. Preoperative     work-up consists of radiological imaging and standardised questionnaires. Follow-up (FU) is     set on two years. During FU, pre-operative imaging and questionnaires will be repeated.      Primary & secondary outcomes:      Primary endpoint will be improvement on the Gastro-Intestinal-Quality-of-Life-Index (GIQLI).     Secondary endpoints will be generic Quality-of-Life, functional results, morbidity,     mortality, recurrences and cost-effectiveness.      Time frame:      Study and inclusion start will be on January the 1st, 2011 and will take approximately 18-24     months. Therefore, total study duration will be 42-48 months.   "
129092|NCT01595399|"     The purpose of this study is to compare heart rate in infants who receive atropine as a part     of their medication before intubation to those who do not.      To be able to find out , we need to divided babies into 2 groups;      group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline (     placebo group) + sedation + muscle relaxant      Then we need to compare heart rate during intubation and duration of intubation between the 2     groups.   "
129093|NCT01595386|"     This protocol is designed to offer insight into critical illness related corticosteroid     insufficiency and steroid supplementation in neonates undergoing cardiac surgery with     cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative     period.   "
129094|NCT01595373|"     The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are     healthy young men. End points are interstitial concentrations of glucose, lactate, and     glycerol.   "
129095|NCT01595360|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in     healthy volunteers after tooth extraction.   "
129096|NCT01595347|"     Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly     immobilized persons, increasing the burden of care to professionals in the health system, as     well as pharmaceutical spending. There are studies of the effectiveness of various products     in the prevention of the UPP, most made in hospitals and using fundamentally composed based     on oily hyperbecome oxygenated acids (AGHO).      There do not exist studies realized specifically with cream of olive oil.      AIMS:      Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized     patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost     - efficiency of this new intervention opposite to AGHO's application.      To value the degree of satisfaction of the patient and his keeper with regard to the use of     cream of olive oil.      METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population     consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients     immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil     to the group of intervention and AGHO's administration to the group control. Follow-up for     one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and     clinical data, presence of technical supports, information of the caragiver and questionnaire     of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio.     Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the     increase cost efficiency (ICER). Logistic regression model multivariant.   "
129097|NCT01595334|"     1. Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions          during menstrual cycle at appropriate plasma levels'        2. In early follicular phase,in the requisite range,LH is known to contribute to maturation          of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2).        3. If during this transition, appropriate level of LH can be maintained either through the          use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or          supplementation with exogenous LH, if found deficient, maturation process can be          enhanced.        4. Further maintenance of suitable combination of recombinant follicle stimulating hormone          (rFSH) + rLH can help in realizing higher yield of mature M2 oocytes,with higher          probability of establishing clinical pregnancy.   "
129103|NCT01595256|"     The aims of this four-year study are to        1. explore the relationships between fatigue and muscle strength (i.e., upper limbs and          lower legs)        2. comparison with the effects of 8-week, 12-week moderate intensity of walking program on          muscle strength and fatigue.        3. develop a clinical guidelines of home-based walking program for patients with colorectal          cancer receiving active treatment and survivors in Taiwan.        4. explore the relationships among the self-report fatigue intensity and metabolism.   "
129104|NCT01595243|"     The aims of this three-year study are to:        1. From patients and family perspective to explore the needs for home care after receiving          TACE, PEI, and RFA        2. Develop a telephone follow-up and consultation program and examine its effect on          self-efficacy, anxiety, depression and quality of life in liver cancer patients          receiving non-surgical treatment.   "
129105|NCT01595230|"     The purpose of this study is to determine whether closure of all mesenteric defects with     clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction-     internal hernias   "
129106|NCT01595217|"     Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI     sequence with MRCP versus MRCP only separately.   "
129107|NCT01595204|"     Prospective multicenter study that aims to evaluate the learning curve of a laparoscopic     score to predict possibility of optimal cytoreduction in patients with ovarian / tubal /     peritoneal advanced at the time of first surgery. The study consists of subjecting all     patients with a clinical suspicion and / or radiological diagnostic laparoscopy (SLPs).      Laparoscopy should be described and recorded in electronic form. After the procedure each     patient will have a Laparoscopic-evaluation-form filled up with a laparoscopic score (PI).     The minimum number of cases to be enrolled is 10 patients, in a minimum time of 1 year. The     data collected and the video should be sent to the Center Coordinator, who will determine the     adequacy of the procedure and the accuracy of the score enrollment is completed for each     center. All eligible subjects will be considered by intention-to-treat population (ITT). For     this phase of the study, it is not necessary know the outcome of the surgical patient (RT) or     if it was then subjected to exploratory laparotomy or less.   "
129108|NCT01595191|"     Exposure to Mozart music significantly lowers resting energy expenditure (REE) in healthy     preterm infants. Whether this finding is related to music per-se or to music by Mozart is     unknown. The objective is to study whether J.S. Bach music has a lowering effect on REE     similar to that of Mozart music.   "
129109|NCT01595178|"     Smoking and drinking are two of the three leading causes of preventable deaths in the United     States today. Using both alcohol and tobacco significantly multiplies the risk of disease and     death from myocardial infarction, COPD, and multiple cancers. Combined use of these     substances is extremely common; people who drink are three times more likely than the general     population to smoke, and tobacco dependent individuals are four times more likely than the     general population to be alcohol-dependent.      Research has shown that there is a high prevalence of unmet substance abuse treatment need     among adult Emergency Department (ED) patients. The current project aims to conduct a pilot     feasibility study with 50 adult ED patients to develop a brief counseling intervention that     is feasible and acceptable to patients who are both smokers and at-risk drinkers to help them     reduce these behaviors.      The overarching aim of this line of research is to find the best treatment for ED patients     who are combo smokers and at-risk drinkers. The study will focus on the development of an     intervention that will be tested in a future larger scale randomized clinical trial.   "
129110|NCT01595165|"     Transversus abdominis plane (TAP) block has gained popularity for the control of     postoperative pain in various surgeries. Three studies showed inconsistent result on pain     control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these     studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid     incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely     extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The     investigators are going to investigate the effect of subcostal TAP on early postoperative     pain after laparoscopic cholecystectomy.   "
129111|NCT01595152|"     Hypothesis:      Objective 1: To advance the investigators understanding on the effect of solifenacin     succinate (10 mg OD) vs. fesoterodine (8mg OD) on urinary urgency using a validated Urgency     Severity and Impact Questionnaire (USIQ).      Hypothesis 1.1: The severity of urgency symptoms as measured by USIQ will change differently     in women with OAB following a 3 month treatment with solifenacin succinate (10 mg OD) vs.     fesoterodine (8mg OD).      Hypothesis 2.1: Condition-specific quality of life (QOL) as measured by USIQ will change     differently in women with OAB following a 3 month treatment with solifenacin succinate (10 mg     OD) vs. fesoterodine (8mg OD).      Objective 2: To advance the investigators understanding on the adverse events (AE's) of     solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD).      Hypothesis 1.1: The severity and rate of AE's in women with OAB following a 3 month of     treatment with solifenacin succinate (10 mg OD) vs. fesoterodine (8mg OD) will be different.   "
129112|NCT01595139|"     MicroRNAs are small molecules which have recently been discovered in cells. They are known to     be responsible for the normal development of cells and when they are disrupted can contribute     to the development of cancer. Many previous studies have been done evaluating the expression     of microRNAs in normal tissues as well as in a wide variety of cancers.      Recently, microRNAs from tumor cells have been detected circulating in the blood of patients     with cancer. This presents a novel opportunity to assess the utility of microRNAs in the     blood as an early predictor of cancer as well as a marker of response to therapy. No previous     studies have been performed evaluating microRNAs in archived tumor tissue and blood of     patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility study     to evaluate the presence of microRNAs in archived tumor tissue and the blood of patients with     NF-1. If the investigators are able to identify circulating microRNAs in this population of     pediatric patients, they will build upon this data in proposing a future study.   "
129177|NCT01594294|"     The purpose of this study was to assess and compare the effect of the repeated usage of 2     different care systems (one hydrogen peroxide based cleaning and disinfecting system and one     PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn     on a daily wear basis for a 3-month period.   "
129113|NCT01595126|"     Biomarkers are small molecules that can be detected in the body fluids of patients; they     often correlate with the presence of a cancer. MicroRNAs and proteins are small molecules     which have recently been discovered in cells. They are known to be responsible for the normal     development of cells and when they are disrupted can contribute to the development of cancer.     Many previous studies have been done evaluating the expression of microRNAs and proteins in     normal tissues as well as a wide variety of cancers.      Recently, microRNAs and proteins from tumor cells have been detected circulating in the blood     of patients with cancer. This presents a novel opportunity to use microRNAs and proteins in     the blood as an early predictor of cancer as well as a marker of response to therapy.     Previous work in our labs have identified miRNAs and proteins in the blood and cerebrospinal     fluid (CSF) of pediatric patients with brain tumors.      To determine a longitudinal evaluation of the presence of microRNAs and proteins in the     blood, cerebrospinal fluid and urine of patients with central nervous system tumors from     diagnosis through the course of their treatment. Though the duration of active treatment     varies significantly based upon the diagnosis, patients will be followed for up to 24 months     after enrollment onto the study).   "
129114|NCT01595113|"     The purpose of this study is to evaluate the safety of the previously conducted clinical     trial cell transplant therapy using Hearticellgram-AMI for patients with acute myocardial     infarction. This is a follow-up observational study and targeting the subjects who     participated in the previously conducted clinical trial.   "
129115|NCT01595100|"     Childhood obesity is a major public health issue, and the identification of children who are     at increased risk of health problems due to their obesity is a priority for modern health     care. Abdominal fat is considered to be the most harmful in the body, and the development of     reliable landmarks and procedures for the assessment of intra-abdominal visceral adipose     tissue and total body fat in children will have a major impact on 1) the early identification     of children at elevated health risk, 2) the proper prioritization of health care resources,     and 3) the standardization of obesity surveillance procedures within and between countries.   "
129116|NCT01595087|"     This phase I/IIa study is a multi-center, prospective, open-label study evaluating safety and     biological efficacy of up to six dose levels of Osteodex of patients with metastatic     castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing     three known substances; dextran, alendronate and guanidine.      The objective of the study is to define the maximum tolerable dose of Osteodex when given     every third week. The following objectives will also be evaluated: overall survival, PSA     response, response markers related to bone metabolism (S-ALP and U-NTx), Quality of Life and     assessment of pharmacokinetic parameters.   "
129117|NCT01595074|"     This research trial studies biomarkers in predicting treatment response in samples from     patients with early-stage non-small cell lung cancer previously treated with adjuvant     chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.   "
129118|NCT01595061|"     This phase II trial studies how well radiation therapy works when given with gemcitabine     hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva     that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor     cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine     hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either     by killing the cells, by stopping them from dividing, or by stopping them from spreading.     Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more     tumor cells.   "
129119|NCT01595048|"     This randomized phase II/III trial studies how well combination chemotherapy with or without     rituximab works in treating younger patients with stage III-IV non-Hodgkin lymphoma or B-cell     acute leukemia. Drugs used in chemotherapy work in different ways to stop the growth of     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping     them from spreading. Monoclonal antibody, such as rituximab, may block cancer growth in     different ways by targeting certain cells. It is not yet known whether combination     chemotherapy together with rituximab is more effective in treating patients with non-Hodgkin     lymphoma or B-cell acute leukemia.   "
129120|NCT01595035|"     Evidence indicates that postoperative pain after day surgery is inadequately controlled.     Patients have different experiences and knowledge about how to deal with pain, and the need     for information and clarification may vary. The aim of this study is to enhance pain     management by academic detailing (patients' current knowledge and motivations are the basis     for information) and nurse coaching (frequent and individualized support). The study consists     of 4 phases; (1) a pilot study about patients experience with pain after surgery by a     structured telephone interview; (2) development of an intervention to improve pain     management; (3) implement and evaluate the intervention; (4) evaluate the incidence of     chronic pain after day surgery. Even if patients are prescribed sufficient doses of     analgesics, pain relief is dependent on patients' adherence with the analgesic regimen.     Psychological factors, such as catastrophizing may also contribute to patients' experience of     postoperative pain. Strategies that may be more effective than general information concerning     surgery and pain management is academic detailing and nurse coaching, and will be used as     frame for the intervention.      Hypothesis:      Over the seven days after surgery patients in the intervention group report;        -  higher adherence with the analgesic regimen,        -  have less pain intensity and pain interference with function and        -  lower severity of side effects compared to the control group.   "
129121|NCT01595022|"     The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01     and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and     pain compared to a placebo T-frame intrauterine system.   "
129178|NCT01594281|"     This study will assess the efficacy and safety of Ranibizumab alone or in combination with     laser treatment vs. laser treatment alone in Proliferative Diabetic Retinopathy. Efficacy     will be primarily measured by the change of area of neovascularizations as measured by     Fluorescein Angiography at month 12 (difference to baseline value).   "
129179|NCT01594268|"     A prospective, open label study of CERtican in KIdney transplantation   "
129122|NCT01595009|"     To provide everolimus to patients with p-NET, GI or lung NETs before potential everolimus     approval, the expanded access study CRAD001K24133 was designed to provide treatment until     disease progression or unacceptable toxicity or until 30 May 2012, whichever occurs first. In     this study, 60 patients with GI or lung NETs were enrolled in Germany and there are still     approximately 40 patients benefiting from everolimus treatment.      To provide the study medication to these patients beyond 30 May 2012, this open label     extension will allow those patients who have been experiencing clinical benefit from     everolimus treatment and who did not suffer from unacceptable toxicity to continue to receive     treatment with the therapy until disease progression, unacceptable toxicity, or until study     end on 31 May 2014, whichever comes first. Patients will be followed for safety and     tolerability and for efficacy of everolimus.   "
129123|NCT01594996|"     The purpose of this retrospective observational study is to evaluate the characteristics of     patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study     will also investigate how the medication is used for these patients and if there are any     differences in drug utilisation between the included countries. The study is observing     patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months     following the launch of the product in each country for the MDD indication. A drug     utilisation questionnaire will be used to collect study data from patients' medical records.   "
129124|NCT01594983|"     This study is to determine a dose response signal for LCQ908 monotherapy and to assess the     efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.   "
129125|NCT01594970|"     This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with     elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular     hypertension (OH).   "
129126|NCT01594957|"     This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of     hepatic impairment to healthy subjects.   "
129127|NCT01594944|"     The investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D     ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other     examinations during pregnancy. The investigators will examine 5-10 women in each gestational     age in order to create a normal values curve throughout pregnancy.   "
129128|NCT01594931|"     This is a double-blind, multicentre, randomised, parallel group, dose-finding study of the     safety, tolerability and efficacy of a three day regimen of the combination of     pyronaridine/artesunate in the ratio 3:1. The primary trial objective is to determine the     clinical effective dose of orally administered pyronaridine/artesunate (3:1 weight/weight)     ratio in the treatment of patients with acute uncomplicated P. falciparum malaria using the     PCR-corrected adequate clinical and parasitological response (ACPR) at Day 28 as primary     endpoint. Secondary trial objectives are to determine the safety of once daily dosing for     three (3) days of pyronaridine+artesunate (3:1) combination in male and female patients with     uncomplicated P. falciparum malaria and to explore possible ethnic differences in safety or     efficacy in the two regions: South East Asia and Africa   "
129129|NCT01594918|"     The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone     (CAMP) in combination at different dose levels and to determine the highest dose that does     not cause bad side effects. The investigators want to find out what effects, good and/or bad,     CAMP has on patients and their metastatic castration-resistant prostate cancer.   "
129130|NCT01594905|"     Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will show effective     antiviral activity and prevent further development of antiviral resistance in hepatitis B e     antigen(HBeAg)-positive or -negative Chronic Hepatitis B(CHB) patients who experienced     multidrug resistance      All subjects will orally take investigational drugs once daily for 48 weeks. All subjects     will be assessed at baseline, Week 4, 12, 24, 36 and 48. Evaluations at each visit will     include vital signs, physical examinations, laboratory tests and HBV DNA levels. They were     also questioned about adverse events and concomitant medications. At baseline and every six     months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be     performed at baseline and 48 weeks.   "
129131|NCT01594892|"     It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly     improves pain relief compared to historic data of conventionally fractionated radiotherapy.     Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain     reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60     patients will be included into this II trial.   "
129132|NCT01594879|"     A prospective multicenter trial has been started in Korea to investigate the treatment     efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone     Acetate(MPA) in Young Women with Early Stage Endometrial Cancer.      The standard treatment for endometrial cancer is total hysterectomy and bilateral     salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young     patients who desire to preserve their potential for fertility may find this standard     treatment difficult to accept. Therefore, the conservative treatment for these patients has     remained a challenge. A number of studies have reported the effectiveness of hormonal therapy     using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma     at stage IA, grade 1, who want to maintain reproductive potential. In addition, several     recent studies reported the use of LNG-IUS to treat patients at a high risk of perioperative     complications who cannot tolerate systemic progesterone because of its adverse effects.     Nevertheless, there has been no prospective multicenter trial that investigated the     effectiveness of treatment with systemic progesterone in combination with intrauterine     progesterone in young women with endometrial cancer.      Therefore, the investigators conducted a prospective trial of the treatment of the presumably     early-stage grade 1 endometrial cancer in young women who desire to preserve fertility by     using oral MPA in combination with LNG-IUS.      Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is     presumably confined to the endometrium, who desired to preserve fertility potential go     through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently.     Follow-up and treatment response assessment were implemented at a 3-month interval with     office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after     removal of LNG-IUS.      The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of     the results between office endometrial aspiration biopsy and dilatation and curettage (D&C)     procedure.   "
129133|NCT01594866|"     The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and     30 mg in patients with major depressive disorder.   "
129134|NCT01594853|"     The purpose is to see how X-linked adrenoleukodystrophy (X-ALD) is associated with strength     and sensation using MRI, in women with X-ALD. The investigators will also see whether     exercise can improve these symptoms for women with X-ALD.   "
129135|NCT01594840|"     This randomized trial has two sets of diapers-- a normal one and one that has tips for how to     talk to and engage your toddler. The investigators are hoping that the intervention improves     language development.   "
129180|NCT01594255|"     This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the     QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.   "
129136|NCT01594827|"     The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in     Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that     persistent infection with MRSA may result in an increased rate of decline in FEV1 and     shortened survival. Currently there are no conclusive studies demonstrating an effective     aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data     demonstrating an effective and safe method of clearing persistent MRSA infection are needed.      The purpose of this study is to evaluate the safety and efficacy of a 28-day course of     vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in     eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA     infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250     mg twice a day) or taste matched placebo and will be followed for 3 additional months. In     addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or     doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes.     Forty patients with persistent respiratory tract MRSA infection will be enrolled in this     trial.   "
129137|NCT01594814|"     Atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating     tachycardia (AVRT) are two similar supraventricular re-entry tachycardias (SVT) emerging in     relatively young age in patients without apparent structural heart disease or significant     comorbidities. The treatment of choice in those patients is radiofrequency ablation (RFA).      The PPRA study is a prospective observational study developed to thoroughly analyze quality     of life, utility and willingness-to-pay of Polish patients undergoing RF ablation of AVNRT or     AVRT.      Based on collected data the investigators will prepare a profile of patient who will benefit     most from radiofrequency ablation and who should be scheduled in first place for the ablation     in case of problems with accessibility to this service.      What is more an analysis of medical and indirect costs of care will be performed.   "
129138|NCT01594801|"     This is the test protocol for the InsuPad device. The aim of the study is to show economical     benefit when using the InsuPad device, by testing the effect of the InsuPad device on     reducing injected insulin dose while keeping the same overall glycaemic control.   "
129139|NCT01594788|"     Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin     (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure     (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB).   "
129140|NCT01594775|"     effects of intranasal oxytocin and couple interaction on wound healing.        -  Trial with medicinal product   "
129141|NCT01594762|"     The purpose of this study is to establish the clinical superiority and the safety of topical     pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus     standard local wound care, in the treatment of mildly infected diabetic foot ulcers.   "
129142|NCT01594749|"     This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3     (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of     fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and     corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated     with moderately emetogenic chemotherapy (MEC).   "
129143|NCT01594736|"     This prospective, randomized trial will compare the extent of covered stent strut segments by     assessed by Optical Coherence Tomography (OCT) of the ORSIRO DES with that of the XIENCE     PRIME DES, which is the standard of choice of contemporary drug eluting stents (DES).   "
129144|NCT01594723|"     The primary purpose of this study is to measure the response rate in participants with the     myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET),     or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an     intolerance to, failure of primary response to, or have demonstrated disease progression     while on ruxolitinib.   "
129145|NCT01594710|"     In Asia, the prevalence of metabolic syndrome have been dramatically increased. Therefore,     the investigators intend to the collect the blood sample, laboratory, anthropometric, and     body composition parameters prospectively to examine the risk factors of metabolic syndrome.     Furthermore, the investigators will collect the data of carotid IMT and branchial ankle pulse     wave velocity to clarify the metabolic risk factors of atherosclerosis.   "
129146|NCT01594697|"     The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of     pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome     (PCOS) women became pregnant during metformin treatment and continued taking the drug during     gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were     performed at each trimester of gestation.   "
129147|NCT01594684|"     In stent restenosis in peripheral artery disease (superficial and popliteal artery) either     treated with uncoated or paclitaxel coated balloons.   "
129148|NCT01594671|"     Total knee arthroplasty is often associated with excessive postoperative bleeding due to     increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to     determine the peri-operative bleeding comparing the application of topical and intravenous     tranexamic acid with the habitual surgical haemostasis.   "
129149|NCT01594658|"     The venous ulcer due to venous insufficiency causes an important morbility to those people     suffering from this condition. Most of therapies available under the obligatory health plan     (POS, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical     handling using saline solutions, topical antibiotics and elastic dressings, implying an     important intake from health resources due to its chronicity and the delay in ulcers healing,     which usually takes periods ranging from 6 months to several years. therapeutical     alternatives, which can guarantee optimal, fast and persistent in time healings, should be     identified.      The aim of this study is to determine the percentage of healing of active venous ulcers     (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6)     following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with     chronic venous ulceration after six months from the intervention, compared with conservative     medical handling. The investigators expect that the ultrasound-guided foam sclerotherapy of     superficial venous reflux will diminish the time of ulcer healing compared with standard     handling.   "
129150|NCT01594645|"     Presently spermatozoa for ICSI are selected based on morphology and motion, without     determining if acrosome reaction (AR) had occurred during sperm preparation or not. Although     not critical if the sperm is injected into the ooplasm, the occurrence of AR might might be     an indicator of better spermatozoon quality and implantation potential, especially in severe     OTA cases. It is impossible with conventional plain optic microscopy used in IVF units to     determine in vivo (without fixation) if AR has occurred, and as a result spermatozoa are     injected randomly. It is readily possible to distinguish AR+ from AR- spermatozoa using     polarized light microscopy due to different bifriengance.      In this study the investigators seek to determine, by a prospective RCT, if selecting only     acrosome reacted spermatozoa, in severe OTA cases, will improve the outcome of ICSI and the     entire IVF process.   "
129151|NCT01594632|"     A study to assess the contraceptive effectiveness of Sino-implant (II).   "
129152|NCT01594619|"     Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics     of naloxegol.   "
129153|NCT01594606|"     The project involves testing the efficacy of an animal-assisted intervention (AAI). The AAI     consists of a 10-week program in which adjudicated adolescents train shelter dogs and will be     compared to a dog walking control group matched for educational content and dog contact time.     The investigators expect that the AAI will result in improved empathy skills and that dog     attachment will explain these findings. The investigators also explore the extent to which     the AAI will improve internalizing and externalizing symptoms in these adolescents.   "
129154|NCT01594593|"     Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause     of death in American men. Those diagnosed with localized prostate cancer encounter three     sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3)     the often life-altering side effects of treatment. In addition, patients who choose to     undergo active surveillance which focuses on monitoring cancer in lieu of treatment,     experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is     an established psychosocial intervention that has been used extensively for mental health     treatment and has shown benefits for various chronic conditions. ACT is a behavioral     intervention that focuses on tolerating distress and improving function. This pilot study is     designed to test the feasibility of ACT for distress reduction and improved quality of life     in patients recently diagnosed with early-stage, localized PCa.   "
129155|NCT01594580|"     This study will test if nurses wearing scrubs treated with an antimicrobial agent while     performing patient care will:      - Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital     shift during routine use after home laundering      This study will gather information by obtaining swabs from scrubs treated with an     antimicrobial and from non-treated scrubs.   "
129156|NCT01594567|"     Dietary pulses, more commonly known as legumes, are generally recognized as healthy     components of the diet. Canada's Food Guide encourages consumptions of meat alternatives,     such as beans more often; and the dietary guidelines for Americans both recommend     consumption of 3 cups of legumes per week. However, there still remain insufficient     information on the usefulness of these foods in protecting heart health. To improve     evidence-based guidance for non-oil-seed pulse recommendations, the investigators propose to     conduct a systematic review of clinical studies to assess the effect of eating pulses in     exchange for other foods on measures of heart disease risk and blood sugar control in humans.     The systematic review process allows the combining of the results from many small studies in     order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The     investigators will be able to explore whether eating pulses has different effects between men     and women, in different age groups, in people with high or normal sugar or blood fat levels,     and whether or not the effect of pulses depends on how much/often they are eaten. The     findings of this proposed knowledge synthesis will help improve the health of Canadians     through informing recommendations for the general public, as well as those at risk of heart     disease and diabetes.   "
129157|NCT01594554|"     A 5-year study to observe and describe long-term patient management and treatment patterns     with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the     CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their     genotype characterized at diagnosis of HCV infection in a real world clinical practice in     China.   "
129158|NCT01594541|"     This retrospective analysis of de-identified data from 700 charts of consecutive patients     from this patient population is to investigate the prevalence of hyperhomocysteinemia and     associated metabolic abnormalities in this naturalistic grouping of patients with various     stages of cognitive loss and diagnosed with various types of dementia.   "
129159|NCT01594528|"     Numerous factors can influence the processing of pain message: the affective or emotional,     the sensorial and the cognitive components. Interindividual variations at the emotional and     cognitive levels may interfere with the pain message and the consecutive behavior. Some     modifications in these components are observed in psychiatric troubles, but their influences     on the behavior to pain have not been studied, although they have been studied in some     populations characterized as non communicating, with obvious cognitive degradations (subject     with dementia, older, newborns,…).In an other study in course, the past pain experience is     explored in relation to results to experimental pain tests, emotional and anxious     characteristics. This present pilot study aims at studying the infra-verbal behavioural signs     during experimentally induced pain in subjects with schizophrenia, major depression, and     controls.   "
129160|NCT01594515|"     In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected     pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.   "
129161|NCT01594502|"     The goal of this study is to apply cutting-edge imaging approaches, incorporating     machine-learning for pattern recognition and multispectral analysis, to the development and     validation of intermediate endpoint biomarkers in benign tissue that characterize the     response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer     among men with negative biopsies.   "
129162|NCT01594489|"     The purpose of this study is to determine whether additional therapy with Aminophylline to     hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to     prevent contrast induced acute kidney injury in patients undergoing primary coronary     intervention for acute ST elevation myocardial infarction.   "
129163|NCT01594476|"     Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead     to negative consequences during the subsequent pregnancy. Providers have traditionally     delayed starting birth control, especially placement of intrauterine devices (IUDs),     post-delivery for a number of reasons. The first postpartum visit after a woman has given     birth is typically scheduled for 6 weeks after her delivery, during which she is typically     provided with her chosen method of birth control. This study will evaluate two different IUD     placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to     determine if placement time affects a woman's follow-through obtaining the IUD and keeping it     inserted in place. The researchers will also look at bleeding patterns and patient/provider     satisfaction with the IUD placement   "
129164|NCT01594463|"     Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of     40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be     associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and     hospitalization in intensive care unit. The investigators hypothesis that a later third     trimester routine ultrasound may be more accurate to diagnose late intrauterine growth     restriction.   "
129165|NCT01594450|"     The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single     blinded trial comparing the use of biological mesh versus traditional wound care without     biological mesh in patients with an infected incisional ventral hernia. The primary endpoint     is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at     45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain,     quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh     structure, and medico-economic evaluation. One hundred patients need to be included.   "
129166|NCT01594437|"     The purpose of this study is to compare the safety profile in healthy adult volunteers of     single or multiple intravenous administrations of TCN-202 as compared with placebo.   "
129167|NCT01594424|"     In this Phase I/II trial, 10 highly sensitized patients will be entered after informed     consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x     5 doses on days 15, 45, 75, 105, 119, 135, and 149. If robust reductions in anti-HLA antibody     are seen, patients will progress to kidney transplantation when an acceptable crossmatch is     achieved with a living donor (LD) or deceased donor (DD). Those receiving transplants will     also receive Tocilizumab infusion monthly X7 doses post-transplant. All subjects will have     intensive monitoring of Donor Specific Antibodies (DSA), viral PCRs, and routine     post-transplant labs. At 6 months post-transplant, those who have retained their transplanted     kidney will have a protocol biopsy.   "
129168|NCT01594411|"     This is a prospective, multi-center study examining the clinical impact of the Corus® CAD     assay in approximately 250 evaluable subjects with no history of obstructive coronary artery     disease who now present with chest pain or anginal-equivalent symptoms to a primary care     physician (PCP) for evaluation.   "
129169|NCT01594398|"     The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of     the experimental drug, entinostat, in women with breast cancer and men and women with     non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated     when entinostat is given by itself as well as with the approved drugs, exemestane (Aromasin®)     or erlotinib (Tarceva®). A biomarker (chemical marker in the blood/tissue that may be     related to your response to the study drug) will also be tested.   "
129170|NCT01594385|"     The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who     are undergoing open abdomen damage control management for traumatic injuries when compared to     no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm     adhesion barrier on:        -  the number and intensity of adhesions,        -  whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm)          who go on to successful definitive abdominal closure,        -  rate of occurrence of secondary complications (such as abscesses) associated with short-          and long-term beneficial effects of reducing adhesion formation,and        -  whether there is any difference between treatment groups regarding patient functional          recovery.   "
129171|NCT01594372|"     Investigators intend to conduct a prospective randomized trial to compare vaginal     hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with     sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for     uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have     not been compared directly. The investigators hypothesize that there is no difference in     objective, subjective, or cost-effectiveness between the two procedures for up to two years     after surgery.   "
129172|NCT01594359|"     The purpose of this study is to determine whether beans bred to have a high iron content are     effective in improving the iron status of young women.   "
129173|NCT01594346|"     The purpose of this study is to determine the safety and effectiveness of 2,000 international     units of Vitamin E (alpha tocopherol)on cognitive function of aging persons with Down     syndrome. It is a randomized, double-blind, placebo-controlled trial lasting 36 months. It is     expected that Vitamin E will slow the deterioration in cognitive functions associated with     Alzheimer disease.   "
129174|NCT01594333|"     The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial     investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death     in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple     coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute     (NHLBI)/National Institutes of Health (NIH).   "
129175|NCT01594320|"     The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian     flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down     into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test     article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment     following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts     of the study.   "
129176|NCT01594307|"     The purpose of this study is to monitor the blood pressure level of the patient using a     preformed cuff ranged 13.5 cm-22 cm.   "
141866|NCT01427556|"     This study is exploring the relationship between food intake behavior and the     hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who     regularly eat breakfast.   "
129184|NCT01594203|"     Soft Tissue Sarcoma (STS) is a rare tumor but can grow in different areas, for example, in     60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. Despite novel     therapy in advanced cases survival is still short, approximately 12 month.      Pazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced     pretreated STS.      Functional imaging especially F18-FDG PET/CT is a good modality for FDG avid tumor either for     pre- / post- treatment evaluation or follow up.      Early detection of treatment response to therapy by whole body FDG PET/CT allows for change     of treatment as early as possible,when the tumor is non-responsive before serious side     effects appear or before depletion of body resources.      The aim of the study is to investigate the contribution of FDG PET/CT to assessment of     treatment response.   "
129185|NCT01594190|"     Stroke is the leading cause of adult disability in Europe and United States and the second     leading cause of death worldwide and affects more than 10,000 Danes each year.      Studies in a late and stationary phase after stroke have shown that physical rehabilitation     is of great importance for survival and physical ability of these patients, however many     studies show that patients lie or sit next to their bed under hospitalization for more than     88.5 % of the daily hours. Physical activity in stroke patients has never previously been     measured immediately after debut of symptoms; furthermore there is no knowledge about the     optimal dose of physical rehabilitation for these patients.      Accelerometers, small measuring devices, are a relatively new way to measure physical     activity precisely, and hence it is possible to obtain an objective measure of how active     stroke patients are in the first week after admission. The accelerometers measure a variable     voltage, depending on the range and intensity of movement. They can measure movement     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.     Studies confirm their reliability, even in patients with abnormal gait, such as stroke     patients.      Another approach of studying the effects of physical activity and rehabilitation is through     the examination of biomarkers. Studies have shown that biomarkers released during physical     activity can inhibit biomarkers released after tissue injury in the brain, as seen after     stroke. These brain biomarkers cause further damage and studies show that the higher the     levels, the higher the damage. It is therefore obvious to examine whether physical activity     rehabilitation can down regulate this destructive process in patients with stroke.      Clarification of the optimal dose of physical activity in stroke patients immediately after     debut of symptoms and examination of both the biochemical aspects of physical rehabilitation     as well as the optimal dose of physical rehabilitation is of great importance for many     patients, their relatives as well as of a great socioeconomic importance.      The purpose of the project is to investigate which dose (15 vs. 2 x 30 minutes) of physical     activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic     stroke, gives patients the best improvement in neurological dysfunction.   "
129186|NCT01594177|"     Anthracycline/taxane based combination chemotherapy of at least 18 weeks represents the     standard of care in the neoadjuvant setting. In HER2 positive disease trastuzumab is given     simultaneously. Neoadjuvant anthracycline-taxane-based chemotherapy given simul-taneously     with trastuzumab achieves a pCR rate of approx. 40%. Recent data showed that a double     blockade of the HER2 receptor (e.g. trastuzumab + lapatinib; trastuzumab + pertuzumab) given     together with a few cycles of chemotherapy can increase the pCR rate by approximately 20%. So     far, there is uncertainty, if afatinib (BIBW 2992), an irreversible HER family blocker can     lead to an even more complete blockade of the HER2 pathway when given in combination with     trastuzumab. The neoadjuvant setting provides the unique opportunity to assess precisely and     at short term the effect of systemic treatment by assessing the pCR at surgery. It also     allows treating patients with HER2 positive breast cancer before surgery without standard     trastuzumab treatment, as, according to current guideline, trastuzumab can also be given     sequentially after surgery. The aim of the study is to show that chemotherapy + trastuzumab +     afatinib can achieve significant pCR rates.   "
129187|NCT01594164|"     In this study the changes in upper airway geometry and resistance between images, obtained in     upright and supine position, will be evaluated. Therefore a Cone Beam Computed Tomography     (CBCT) scan and a low dose Computed Tomography (CT) scan will be taken in a population of 20     subjects. The upright morphology will be obtained using CBCT scan while the supine upper     airway geometry will be determined using a standard High Resolution Computed Tomography     (HRCT) scanner.   "
129188|NCT01594151|"     Asthma in children is recognized as a disease area with a high medical need. As the     investigators move into this field it is necessary to improve the investigators knowledge of     upper airway anatomical structure in paediatric patients. This study will provide     airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can     be used in order to build models to study the delivery of medication through a device that     requires for example a facemask. In this study the anatomical structure of the upper airway     and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan.     The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.   "
129189|NCT01594138|"     The purpose of this study is to determine whether patients who have a high risk for serious     suicide behavior will demonstrate a speech pattern that has a relationship to language     patterns found in suicide notes.   "
129190|NCT01594125|"     The aim of the study is to investigate the safety, tolerability, efficacy and     pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to     curative surgery or loco regional therapy   "
129232|NCT01593579|"     Some Akt inhibitors have produced functional cardiovascular effects such as marked     hypotension that may limit their clinical benefit. There are no current data on whether this     autonomic failure presents in humans at clinically used doses. We will test the hypothesis     that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.   "
129233|NCT01593566|"     Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for     analgesia after Anterior Cruciate Ligament (ACL) reconstruction.   "
129191|NCT01594112|"     The purpose of the THORN registry is to show the ability of Home-Monitoring® to early     identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients     (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single,     dual, or triple chamber).      The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to     early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate     therapies (IT), and to take preventive actions in order to reduce the burden of these     inappropriate therapies.      THORN is an observational epidemiologic, prospective and multicenter registry. The primary     objective is to measure the relative proportion of patients experiencing at least one     inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess     the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD     patients.   "
129192|NCT01594099|"     The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin     /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced     cervical cancer in elderly women.   "
130328|NCT01579110|"     The purpose of this study is to determine whether Levamisole plus prednisone can further     improve the efficacy，extend the remission duration and reduce the dosage of prednisone for     newly diagnosed warm antibody autoimmune hemolytic anemia.   "
129193|NCT01594086|"     Green tea contains catechins and theanine as major ingredients and has been reported to have     various beneficial influences on human health. It is reported that the drinking green tea is     inversely associated with serum homocysteine level in elderly. However the effect of green     tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this     study is to investigate the effects of green tea consumption on homocysteine metabolism and     cognitive dysfunction in elderly with impaired cognitive function.   "
129194|NCT01594073|"     Implantable cardioverter-defibrillator (ICD) therapy reduces mortality in patients with     chronic heart failure and reduced left ventricular ejection fraction (LVEF) <36%.     Nevertheless, patient selection for ICD therapy based on LVEF and NYHA functional class alone     seems to have a low specificity and sensitivity: In 100 patients treated, the SCD-HeFT study     prevented 7 deaths in 5 years. Therefore 93 patients have a risk of adverse effects, such as     operation risk, infection, pneumothorax, lead dislocation, and inadequate icd therapy. On the     other hand, patients with advanced or end stage heart failure might rather die off     progressive heart failure death and thus not benefit from ICD therapy.      It therefore seems appropriate and necessary to improve the individualized risk     stratification in these patients. The aim of this study is to evaluate multiple cardiac     biomarkers in a model predicting ventricular arrhythmias in patients on ICD therapy.   "
129195|NCT01594060|"     A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized     in the medical department. The first approach is called basal-bolus in which 4 insulin shots     are given daily ( 3 short acting before meals and one long acting before bed time). The     second approach is called sliding scale in which short acting insulin alone is given before     meals and before bed time according to the patient's glucose values. The aim is to keep     fasting glucose between 140-180 mg/dl.   "
129196|NCT01594047|"     Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents     opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal     surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a     N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative     Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia     after abdominal surgery.   "
129197|NCT01594034|"     Our objective is to determine whether or not the presence of hemoperitoneum in trauma     patients is associated with increased Carbon Monoxide (CO) formation, and to determine if     elevated Carbon Monoxide levels are associated with cardiovascular depression, impaired     platelet aggregation, and/or multiple organ failure.   "
129198|NCT01594021|"     Induction of general anesthesia induces frequently arterial hypotension. The short term goal     of this study is to evaluate if preemptive volume loading prevents such complication.   "
129199|NCT01594008|"     The goal of the study is to find out whether a high fat meal increases blood lipids and     causes monocyte (white blood cell) activation, and whether blueberry intake at the same meal     lessens monocyte activation in healthy people.   "
129200|NCT01593995|"     Epidermal growth factor receptor-tyrosin kinase inhibitor (EGFR-TKI, Erlotinib) has     demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer.     But, their use is associated with dermatologic reactions of varying severity. Incidence of     Erlotinib related skin effect (ERSE) was reported ~75% in NSCLC and pancreatic cancer phase     III trials. Even though the dermatologic reactions could be a surrogated marker, it may be     cause of dose modification. Also, it could give significant physical and psycho-social     discomfort to patients. However, there is still a wide variety of drugs used- including,     steroid, antibiotics, and vitamin D without any clear evidence based management     recommendation.      The role of epidermal growth factor (EGF) has been extensively investigated in normal and     pathological wound healing. It is implicated in keratinocyte migration, fibroblast function     and the formation of granulation tissue. The first growth factor to be isolated growth factor     therapy has progressed into clinical practice in the treatment of wounds.      Therefore, the investigators propose an epidermal growth factor ointment apply for patients     with Erlotinib related skin effects.   "
129201|NCT01593982|"     Even in the absence of a preliminary diagnosis of Attention Deficit Hyperactivity Disorder,     symptoms of attention deficit, hyperactivity and cognitive impairment are common in cocaine     addicts.      Several factors indicate that repetitive transcranial magnetic stimulation might be a     strategy to aid in the treatment of symptoms of attention deficit hyperactivity disorder and     cognitive function in cocaine addicts.      However, up to current days there have been no studies evaluating the effects of Repetitive     Transcranial Magnetic Stimulation (rTMS) on neurocognitive performance of individuals     suffering from the ADHD.   "
129202|NCT01593969|"     The investigators will perform a randomised controlled trial of the provision of food     designed for rehabilitation of malnourished children that is supplemented with n-3 fatty     acids compared to usual composition. The investigators want to see whether the provision of     such a food normalises the deficiencies in essential fatty acids observed in severely     malnourished children faster than standard composition.   "
129234|NCT01593553|"     The purpose of this study is to determine whether screening for atrial fibrillation by     intermittent ECG recording and initiation of anticoagulation treatment among high risk     individuals is cost-effective and can lower the incidence of stroke.   "
129203|NCT01593956|"     Concussed athlethes have discrete decreased abilities in motor learning. Recent research     could further show, that cortical plasticity, as measured by transcranial magnetic     stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what     have been found in concussed athletes by paired pulse protocols in TMS.      GABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a     polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS increased     tDCS.      Our study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed     athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in     concussed athlethes.   "
129204|NCT01593943|"     The major barrier to India meeting its national goal of replacement fertility is the huge     discrepancy between urban and rural family planning, with rural young women at highest risk     for unplanned and unspaced pregnancies. These concerns are considered to drive the persistent     and unacceptably high rates of maternal and infant mortality in India. Major impediments to     these young wives' acquisition of family planning services include high male partner control     over reproductive decision-making, low mobility, and very low access to family planning     services in villages. Such findings document the need for male-centered family planning     efforts available at the village level, to better meet the needs of rural young wives. These     male-centered efforts must address male gender role and gender inequity ideologies and norms     (e.g., son preference, wife abuse) and marital communication, as these factors are associated     with lower likelihood of contraceptive use in rural young Indian couples. Hence, the proposed     study involves development and testing of the CHARM Program, a gender equity (GE)-focused,     male-centered family planning (FP) program delivered by village health providers (VHPs), via     a public-private partnership with primary health centers (PHCs) and private providers serving     rural India. In Phase 1 the investigators will conduct formative research including health     care resource mapping of Vasai within the Thane district of Maharashtra to identify villages     and VHPs for inclusion in subsequent research and intervention. The investigators will also     conduct in-depth interviews with rural young husbands (n=30), rural young wives (n=20), and     health care providers (n=12), as well as focus groups with mothers' of rural young husbands     (n=40). These data will be used to develop the CHARM program and efficacy trial. Phase 2 will     involve development and pilot testing of CHARM protocols and training of VHPs for their role     in the intervention trial (Phase 3). The CHARM intervention will involve VHP-delivered GE and     FP counseling. It is delivered via a single session with 2 optional additional sessions one     of which would include their wife. Phase 3 will involve evaluation of CHARM, using a     two-armed randomized controlled trial design. Villages (N=50) will be randomized to receive     either CHARM or the control program (standard FP referral to government public health centers     [PHCs] located outside of villages), to assess treatment impact on spacing contraceptive use,     pregnancy, and unmet family planning need. Intervention effects will be assessed via     behavioral surveys with rural young husbands (18-30 years) and their wives (N=1000 couples,     20 couples per village) at baseline and 9 and 18 month follow-up, as well as pregnancy tests     from wives, conducted at baseline and 18 month follow-up. A process evaluation will be     undertaken via interviews with study participants and VHPs, as well as through VHP interviews     and clinical record review, to assess program adherence, participation rates, response to     program, and ease of delivery. In-depth interviews will also be conducted with key informants     from the village and public and rural health systems to assess sustainability and     institutionalization of the model.   "
129205|NCT01593930|"     The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular     firs molar following infiltration of 4% articaine alone and as supplemental injection after     inferior alveolar nerve block(IANB).   "
129206|NCT01593917|"     To collect long term follow up study data of the Trifecta valve in subjects who had the     Trifecta valve implanted during the IDE study.   "
129207|NCT01593904|"     1. What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS          patients and controls.        2. Are the beneficial outcomes from treatment placebo? By measuring changes in brain          perfusion and Cerebrospinal flow before and after the procedure on a large number of          patients to determine these outcomes   "
129208|NCT01593891|"     Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic     Cerebral Spinal Venous Insufficiency Treatment   "
129209|NCT01593878|"     This study aims to test whether middle school students test performance is affected by     background TV. Students will complete a high school entrance exam either with or without a TV     on in the test room. Scores will be compared.   "
129210|NCT01593865|"     The present study hypothesizes that the systematic use of bilateral internal mammary artery     (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for     the treatment of multivessel coronary artery disease (primary hypothesis). The secondary     study hypothesis is that the BIMA grafting meets the safety endpoint compared with the     conventional surgical strategy entailing left mammary artery grafting plus great saphenous     vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is     that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms     related to coronary disease, of repeat revascularization and of cardiac mortality compared     with patients treated with the conventional surgical strategy entailing left mammary artery     grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.   "
129211|NCT01593852|"     Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image     noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose     significantly. This is realized by anatomy-specific optimization of the full acquisition     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and     shorter pulses are used, which are known to positively influence image quality .      The primary aim of this study is to verify if a significant reduction in total procedural     X-ray dose during electrophysiological interventions can be achieved by using advanced image     processing (Allura Clarity).   "
129212|NCT01593839|"     The main objective of this study is to investigate the muscle metabolism in individuals with     chronic non-specific low back pain (CNSLBP) to enhance our understanding of chronic back     pain.   "
129213|NCT01593826|"     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.   "
129214|NCT01593813|"     The theoretical benefits of the repair of the pronator quadratus include flexor tendon     protection, remain of the normal pronation-supination range of motion (ROM) and strength, and     keeping the stable DRUJ.      Repair or not repair pronator quadratus in the volar plating of distal radial fracture-Are     functional outcomes differ?   "
129215|NCT01593800|"     Lactose intolerance (LI), also known as lactose malabsorption is the most common type of     carbohydrate malabsorption. It is associated with the inability to digest lactose into its     constituents, glucose and galactose, due to low levels of lactase enzyme activity (1-2). At     birth, lactase activity is at the highest and it declines after weaning (1-2). The unabsorbed     lactose is metabolized by colonic bacteria to produce gas (hydrogen (H2) and methane (CH4))     and short chain fatty acids. Symptoms related to LI appear 30 minutes to 2 hours after     consumption of food products containing lactose. Related symptoms include: bloating,     cramping, flatulence and loose stool (1-2, 17-18).      Highest rates of LI are found in the Asian populations, Native Americans and African     Americans (60-100%), while lowest rates are found in people of northern European origin     (including northern Americans) (3-4).      The diagnosis of LI based on patients' symptoms is sometimes problematic, since these     symptoms are not specific and may differ from one patient to another. Breath hydrogen test     have been advocated as the best diagnostic tool for the assessment of LI (15-16). During the     test, subjects are sampled for hydrogen levels of breath samples at base line and every 30     minutes after the administration of 50 grams of oral lactose, for a total period of 180     minutes. A breath sample with > 20 ppm above baseline is considered positive for LI (15-16).      There are no established treatments for LI, other than almost complete avoidance of lactose     rich dairy products. Avoidance of dairy products is a major concern since its outcome may     result in a dietary calcium intake that is well below recommended dose of 1,000 mg per day     for men and women and 1,300 mg for adolescents (8-10). For this reason different course of     action needs to be considered instead of a complete exclusion of dairy products by LI     patients.      Two possible interventions in the case of LI are the supplement of commercially available     lactase (tablets) or the addition of probiotics.      The consumption of lactase enzyme as a food supplement may assist in restoring adequate     levels of the enzyme needed for hydrolysis of lactose, especially for patients with low, or     non existent levels of lactase. On the other hand, lactase products are problematic since not     all lactase preparations are of the same concentration. Moreover, it is difficult to asses     the amount of lactase tablets needed in order do fully hydrolyze lactose in each dairy mill     (14).      Probiotics are live microorganisms that are commonly used in order to prevent or treat a     disease. The current definition by the Food and Drug Administration and the World Health     Organization is Live microorganisms which, when administered in adequate amounts, confer a     health benefit on the host. These microorganisms are a heterogeneous group, they are     nonpathogenic and produce beta- galactosidase or lactase intracellularly that may assist in     the digestion of lactose (11).      Studies have shown that people with lactose intolerance tolerated the lactose in yogurt     better than the same amount of lactose in milk. The assumption was that the presence of     lactase producing bacteria in the yogurt, especially Lactobacillus acidophilus, contributed     to the digestion and absorption of lactose (5-6, 13).      It was also found that the presence of Lactobacillus bulgaricus and Streptococcus     thermophilus alleviate lactose intolerance through their ability to produce lactase enzyme     (7).      Finally, in another study it was found that consumption of milk containing Bifidobacterium     longum resulted in significantly less hydrogen production and flatulence as compared to the     consumption of control pasteurized milk (12).      Based on the mentioned data, the investigators speculate that the administration of     probiotics may assist with the consumption of dairy products containing lactose. Therefore,     the aim of this study is to evaluate the effect of probiotics on patients with LI.   "
129216|NCT01593787|"     This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients     with renal dysfunction.   "
129217|NCT01593774|"     The purpose of this study is to determine whether melatonin can prevent metabolic side     effects of olanzapine such as weight gain, elevated glucose concentrations and lipid     abnormalities.   "
129218|NCT01593761|"     Primary Objective:      To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with     cABSSSI (major cutaneous abscesses) due to MRSA.      Secondary Objective(s):        -  To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due          to MRSA        -  To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.        -  To assess the safety of multiple doses of CG400459   "
129219|NCT01593748|"     This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs     Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this     study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with     Gemcitabine and Docetaxel in participants with soft tissue sarcoma.   "
129220|NCT01593735|"     This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts.     Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II     will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or     may be staggered.   "
129235|NCT01593540|"     The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding     Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig     metal-core interdental brush.   "
129236|NCT01593527|"     The purpose of this study is to confirm the efficacy and safety results obtained in a chronic     kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger,     independent patient population with difficult to treat gouty arthritis and moderate to severe     CKD (stage 3 - 4).   "
129535|NCT01589601|"     The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary     palliative care intervention combined with usual heart failure management on health-related     quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the     Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.   "
129237|NCT01593514|"     The bacterium (germ) Neisseria meningitidis causes meningitis and blood poisoning. N     meningitidis is classified into different serogroups (types), based on its outer     polysaccharide (carbohydrate) capsule. Serogroups A,B,C,W & Y are responsible for the vast     majority of meningococcal disease worldwide.      Older vaccines against types A,C,W & Y contain part of the polysaccharide capsule of the     germ. However, these polysaccharide vaccines do not provide long-term protection against     disease and are less effective in young children, the group most at risk of meningococcal     disease. Newer conjugate ACWY vaccines attach a polysaccharide to a protein carrier - these     provoke a good response in young children and can provide long-term protection.      White blood cells called B cells produce antibodies, which are the main components of     protection against meningococcal disease. Although many studies have investigated the immune     response to these vaccines in different age groups by measuring specific antibodies, there is     limited information about the B cells underlying such an immune response. Several different     subsets (populations) of B cells exist in the blood. Previous studies by the investigators     group suggest that different numbers of B cells are produced in response to each vaccine     type. However, little is understood about which subset of B cell is important for antibody     production in response to these polysaccharide or conjugate vaccines.      This study aims to provide detailed information on the immune response to meningococcal     vaccines by investigating the appearance of B cells and their subsets in the blood after     vaccination with the polysaccharide and conjugate vaccines. These observations will help us     understand how polysaccharide and conjugate vaccines stimulate the immune system in different     ways. This knowledge will help in the development of new vaccines that are effective across     all age groups.      The investigators aim to recruit 20 adults aged 30-70 from Oxfordshire. The study will be     funded by the Oxford Vaccine Group.   "
129221|NCT01593722|"     Background:        -  Loa loa is a small worm that infects people in West and Central Africa. It is spread by          the bite of a fly. Adult worms live under the skin and can cause swelling in the arms,          legs, and face. Some people have more serious infections in the heart, kidneys, or          brain. Most people with Loa loa infection have no symptoms at all. The standard          treatment for Loa loa infection is a medicine called diethylcarbamazine (DEC). Some          people have bad reactions to DEC, including itching, muscle pains, and in severe cases          coma and death.        -  Another drug, ivermectin, is used in mass drug treatment programs to prevent the spread          of worm infections that cause blindness and massive swelling (elephantiasis). However,          people who also have Loa loa have had serious bad reactions to ivermectin. Researchers          want to study both DEC and ivermectin to find out why these reactions occur. If they can          be prevented, mass drug treatment programs will be able to be used in areas in Africa          where Loa loa exists.      Objectives:      - To study the side effects of DEC and ivermectin treatment for Loa loa infection.      Eligibility:      - Individuals who live in 4 villages in Cameroon where Loa loa infection is known to exist,     who are between 20 and 60 years of age, not pregnant or breastfeeding and have a low level of     Loa loa parasites in the blood, but are otherwise healthy.      Design:        -  Participants will be screened with a physical exam and medical history. Blood samples          will be collected to check for Loa loa infection. Participants will also have an eye          exam and provide skin samples to check for other worm infections that may interfere with          the study treatment.        -  Participants will be admitted to the hospital for 4 days (during and after the          treatment). They will receive a single dose of either DEC or ivermectin.        -  After treatment, regular blood samples will be collected. Participants will be asked          questions about how they feel after treatment. Physical exams will be performed. If side          effects develop, participants will be treated at the hospital.        -  After leaving the hospital, participants will have followup visits. These visits will          happen on days 5, 7, 9, and 14 after receiving the study medicine. They will involve a          short physical exam and collection of blood samples.        -  At the end of the study, participants will be offered a full 21-day DEC treatment to          cure the Loa loa infection.   "
129222|NCT01593709|"     Background:      - Vaccines and antiviral therapies are critical for preventing and treating viral diseases.     Testing these vaccines and drugs often requires healthy volunteers. To ensure that volunteers     are healthy and eligible to participate in these studies, they will be screened before the     start of the study. This screening may involve a medical history, physical exam, and blood     test. Other samples may also be collected. This study will help identify volunteers who are     eligible to participate in vaccine or antiviral therapy trials.      Objectives:      - To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus     infections.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  Screening may begin several months before the start of the clinical trial. Participants          may come to the National Institutes of Health clinic one or more times.        -  Participants may be screened with a physical exam and medical history. Blood samples          will be collected. Other samples may also be collected, including urine, nasal wash,          nasal swab, or stool samples. All samples will be stored for reference by the study          researchers....   "
129223|NCT01593696|"     Background:      - Although progress has been made in treating children with B-cell cancers such as leukemia     or lymphoma, many children do not respond to the standard treatments. One possible treatment     involves collecting white blood cells called T cells from the person with cancer and     modifying the cells to attack the B-cell cancer. The cells can then be given back to the     participant. This study will use T cells that have been modified to attack the CD19 protein,     which is found on the surface of some B-cell cancers.      Objectives:      - To see if anti-CD19 modified white blood cells are a safe and effective treatment for     children and young adults with advanced B-cell cancer.      Eligibility:        -  Children and young adults between 1 and 30 years of age who have B-cell cancer (leukemia          or lymphoma) that has not responded to standard treatments.        -  The leukemia or the lymphoma must have the CD19 protein.        -  There must be adequate organ function.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies or bone marrow biopsies may be performed          depending on the type of cancer.        -  Participants will undergo a process where white blood cells are collected, called          apheresis. These cells will be modified to contain the anti-CD19 gene.        -  Participants will have 3 days of chemotherapy to prepare their immune system to accept          the modified cells.        -  Participants will receive an infusion of their own modified white blood cells. They will          remain in the hospital until they have recovered from the treatment.        -  Participants will have frequent follow-up visits to monitor the outcome of the          treatment.        -  If the participant benefits from the treatment, then he/she may have the option for          another round of treatment.   "
129224|NCT01593683|"     The purpose of this study is to test a brief education program for oncology nurses, to     enhance their skills for managing psychosocial stressors associated with providing direct     patient care. The investigators will explore efficacy of the intervention for reducing     psychological stress and medical errors.   "
129225|NCT01593670|"     This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice     daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer     (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell     survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The     intent is to administer all treatment in the outpatient setting.   "
129226|NCT01593657|"     The purpose of this clinical trial is to understand if women undergoing surgery for a     suspected gynecologic malignancy are interested in participating in a Mindful Movement and     Breathing program and what the effects of this program are on women and the surgery-related     symptoms they experience. Mindful Movement and Breathing programs may be effective for easing     distress, post-surgical pain, and other symptoms of surgical procedures.   "
129227|NCT01593644|"     The purpose of this study is to evaluate the efficacy and tolerance of a     dipyridamole/adenosine combination given intravenously, as a slow bolus and at low doses to     adenosine alone (given at its recommended dosage adjusted to patients' weight) for coronary     flow reserve assessment (in 60-75 patients with stable ischemic heart disease) using     transthoracic echodoppler   "
129228|NCT01593631|"     Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose     malabsorbers than unfermented dairy products. The intake of dietary supplements containing     acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to     reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to     compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the     effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose     malabsorbers. It is hypothized that the combination preparation will be more effective and/or     will show a more reliable effect than the two mono-preparations.   "
129229|NCT01593618|"     This is a randomized controlled trial of a web-based informational intervention (UMFollowUp)     for adolescent and young adult survivors of childhood cancer to improve cancer knowledge and     psychosocial functioning.   "
129230|NCT01593605|"     The study will evaluate the effects of resveratrol/leucine and resveratrol/HMB for their     ability to control glucose levels in persons without diabetes but with impaired fasting     glucose. Secondary assessments will examine the effect of these nutritional supplements     versus placebo on inflammation, fasting lipids, HbA1C, and fructosamine, longer term     metabolic markers of risk in diabetes.   "
129231|NCT01593592|"     Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.   "
129536|NCT01589588|"     This study will investigate the possible difference in treatment effect between three     different oxygen delivery systems in the acute treatment of cluster headaches.   "
129238|NCT01593501|"     The investigators aim to recruit 60 women who have agreed to participate in an existing     randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC     2009-0055). In this trial, the investigators propose to evaluate the associations between     magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis.     The investigators will stratify 60 subjects in the sub-study, ensuring that approximately 20     subjects are randomized into each treatment arm (placebo, low-dose and high-dose vitamin D).     The investigators already assess calcium homeostasis throughout the study by measuring bone     mineral density, fractional calcium absorption, serum and urine calcium levels, among other     tests. In the sub-study of 60 women, the investigators will evaluate whether habitually     higher magnesium intake increases or decreases fractional calcium absorption. The     investigators will evaluate the interplay between magnesium stores, vitamin D levels and     serum parathyroid hormone levels. The investigators will directly assess magnesium stores     using serum magnesium and 24-hour urine magnesium levels, and will measure magnesium     absorption using the dual stable isotope approach.   "
129239|NCT01593488|"     The purpose of this study is to describe the activity and toxicity of a new formulation of     cytarabine called liposomal cytarabine given into the central nervous system for the     treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in     children and adolescents.   "
129240|NCT01593475|"     This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed     by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer     patients with locally advanced disease and the purpose of this trial is to evaluate the     efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable     pancreatic carcinoma.   "
129241|NCT01593462|"     The purpose of this study is to determine the efficacy of ultrasound imaging compared to MRE     (Magnetic Resonance Enterography) a form of magnetic resonance imaging (MRI) in accurately     diagnosing and following Small Bowel Crohn Disease (SBCD) in children.   "
129242|NCT01593449|"     The present study aims to initially test a community dog walking intervention that addresses     individual, interpersonal and community factors associated with dog walking. The study will     be conducted in two cities, Worcester and Lowell, as a collaboration between investigators     from UMass Medical School and UMass-Lowell.   "
129243|NCT01593436|"     Summary      Introduction: Insomnia is a symptom of sleep disorders most prevalent. Primary insomnia, the     investigators analyzed, often related to stress states acquired, generalized anxiety and     stress, which are important factors that disrupt normal sleep. The investigators point out a     fact that still intrigue the students of medicine and sleep that is distorted perception of     sleep by the sleepless nights, polysomnography shows greater effectiveness than that     perceived by them. On the other hand, there is evidence that mindfulness techniques may     reduce symptoms of stress and anxiety as well as improve the general attention, which may     contribute to a better perception of the effectiveness of sleep. In addition, there are     studies showing that meditation is associated with metabolic and neurophysiological     characteristics similar to normal sleep. Objectives: To compare sleepless menopausal women     trained for 8 weeks in the technique of mindfulness insomniac postmenopausal untrained and     also assess the quality of sleep experienced meditators menopausal comparing them to the     group of healthy postmenopausal women untrained in the art.   "
129244|NCT01593423|"     The project is a three arm randomized control trial in rural Cambodia designed to evaluate     the impact of homestead food production (home gardens) with and without fish ponds versus     control on household food security, dietary intake of women and youngest child, biochemical     nutritional status of women, and household livelihoods over a 22 month period. Baseline and     end line surveys will be conducted that involve questionnaires and a blood sample.   "
129245|NCT01593410|"     The purpose of this study is to determine the efficacy of lenalidomide plus low-dose     dexamethasone in Chinese subjects with relapsed or refractory multiple myeloma.      Even though the efficacy and safety of lenalidomide has already been well-demonstrated in     other populations including Asians, this study will assess the efficacy and safety as well as     pharmacokinetics of lenalidomide in Chinese subjects. In addition, this study will generate     clinically meaningful information in guiding the therapeutic use of lenalidomide for Chinese     subjects.   "
129246|NCT01593397|"     The primary objective of this study is to determine the influence of insulin resistance on     drug metabolism and response in obese subjects. The investigators hypothesize that expression     of adiponectin (a hormone secreted by fat tissue), and specific variants in the adiponectin     gene can predict the insulin resistance and drug response among obese subjects.   "
129260|NCT01593215|"     The investigators have recently discovered a genetic variant in an adrenergic receptor that     leads to increased risk for type 2 diabetes. The investigators have also seen that blockers     of that receptor improves impaired insulin secretion in animals. The investigators will now     test the blocker in patients with type 2 diabetes with or without the risk variant in an     effort to make diabetes treatment more individualized.   "
129537|NCT01589575|"     The main objective of this study is to compare the rate of reported anxiety / depression     (HADS >= 8) among spouses and other family members in ICU patients.   "
129538|NCT01589562|"     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and     Megace 800mg/20ml in healthy male volunteers under fed condition.   "
129247|NCT01593384|"     Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion     detection in dense breasted women. Even though DBT has been regarded as a study for dense     breasted women, it may also improve lesion detection at an earlier stage and smaller size in     women with less dense breast tissue. The overlapping of tissue on a standard of care 2D     mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that     mimic cancers. This leads to patients being asked to come back for additional imaging     including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by up     to 43% in reader studies. Even though these results are promising they were not done in a     realistic clinical setting.The purpose of this study is to evaluate the FDA-approved     combination standard digital mammography (DM) and DBT technology and its impact on our     clinical practice.   "
129297|NCT01592734|"     The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of     a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal     impaction and in the treatment of chronic constipation   "
129248|NCT01593371|"     Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with     type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin),     are two major groups of hypoglycemic medications that while function via different pathways,     are both effective in short- and long-term glycemic control . These medications diminish or     at least delay long term micro- and macrovascular complications associated with prolonged     insulin resistance although at different rates. The mechanisms by which this aim is achieved,     nevertheless, remains largely unclear. With adipokines playing a key role in development of     both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these     substances by direct and indirect routes.   "
129249|NCT01593358|"     To establish if there are venous obstructions in patients with neurodegenerative disorders   "
129250|NCT01593345|"     The population is aging and chronic conditions, which are major causes of pain and mobility     limitations, are on the rise, however, current access to physiotherapy is difficult.     Knowledge on managing disability is substantial, but methods to translate into action are     lacking. This project is designed to test a novel method of promoting function in vulnerable     seniors and simultaneously develop awareness in the new generation of physiotherapists that     they can have a proactive role in health promotion. The investigators are proposing a pilot     project targeting both students and patients.      The research question are (1) What are the needs of vulnerable patients at the MUHC? Two     groups will be targeted; newly discharged seniors (who will be eligible for an intervention)     and cancer outpatients who will be surveyed only);(2) For a senior population at risk for     physical deterioration, to what extent is a personalized mentoring approach to optimizing     function and preventing disability through developing self-management skills more effective     in improving outcomes than the provision of written material covering the same general     content? (3) Does a mentoring experience with vulnerable seniors through development and     teaching of a self-management program (comprised of education and support) produce meaningful     positive changes in future clinicians' knowledge, skills and attitude towards modes of     delivering physiotherapy services and promoting self-management in Canadian seniors?      There are two phases to this study: a survey and randomized controlled trial (RCT). The     survey phase will identify mobility needs of two groups, newly discharged seniors and cancer     outpatients. The needs assessment for newly discharged seniors will identify people eligible     for the (RCT) component; the needs assessment for cancer outpatients will inform the     development of interventions for this specific group. The RCT component will be piloted for     recently discharged community dwelling seniors 70 years and older only.      A sample of 400 seniors recently discharged from the adult, general, hospital sites of the     MUHC will be contacted for a needs assessment. From this pool, the investigators anticipate     100 will be eligible and 60 will be randomized, 30 to the mentor intervention and 30 to the     control group. Participants will be followed-up for 6 months and assessments will be     performed at 2 time points (baseline and 6 months). The main outcome is a standardized     response ratio (SRR) estimated across all persons and measures. SRRs will be calculated for     three groups of response variables: impairment/mobility measures, quality of life indicators,     and health services outcomes.      In parallel, to determine cancer survivor needs, the investigators will contact 600 cancer     survivors; as the investigators anticipate 400 will answer the survey. The analysis of this     survey will consist of frequency of specific needs by diagnosis and treatment.   "
129251|NCT01593332|"     In this project the investigators decide to evaluate the efficacy and safety of half dose     mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of     rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs     limited in the investigators refractory patients as the first line drugs because of its cost.   "
129252|NCT01593319|"     The main hypothesis of the study is that anaesthesia of the hip using infiltration with a     local anesthetic solution is preferable over traditional analgesia with oral opioid     medications in the acute stage of the management of patients with a fracture of the hip.      To study the hypothesis the investigators designed a prospective randomised study where     patients are assigned in two groups, the first receiving local hip anesthesia and the other     placebo treatment. Both groups are eligible to use of standard oral pain treatment.      Effect of analgesia as well as medical complications will be recorded.   "
129253|NCT01593306|"     The purpose of this study is to check whether addition of paclitaxel to cisplatin and     radiation therapy will improve the outcome in locally advanced carcinoma cervix.   "
129254|NCT01593293|"     The number of NSCLC patients above 70 years of age who are non-squamous histology is     increasing around the world. Although previous guidelines often recommend single agent     therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard     monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with     non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy     in terms disease progression, overall survival, and quality of life and tolerability.   "
129255|NCT01593280|"     Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and     pruritus, which may affect quality of recovery. The investigators hypothesize that     long-acting local anesthetic infusions via TAP catheter can provide better quality of     recovery after cesarean section than spinal morphine.   "
129256|NCT01593267|"     With evolving endovascular technologies there is a growing debate centered on the relative     safety and efficacy of the currently accepted alternatives for the treatment of ruptured     cerebral aneurysms in the face of acute subarachnoid hemorrhage (SAH). The purpose of this     study is to compare the safety and efficacy of microsurgical clipping and endovascular     coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.   "
129258|NCT01593241|"     The main objective of this trial is to test the efficacy and safety of carboplatin     chemotherapy and involved node radiotherapy in patients with stage IIA/B seminoma.   "
129259|NCT01593228|"     The purpose of this study is to assess the safety and tolerability of iniparib administered     as monotherapy or in combination regimens in patients previously treated with iniparib in a     clinical study and who have derived clinical benefit after completion of the parental study's     objectives.   "
141867|NCT01427543|"     The goal of this study is to determine whether a culturally congruent, group intervention can     reduce HIV risk behaviors among recently incarcerated, bisexual, African American men.   "
129261|NCT01593202|"     The purpose of the study is to evaluate the long-term efficacy of dialectical behavior     therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced     usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been     included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was     repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of     outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have     been assessed so far on five different time-points: baseline (before starting treatment), 9     weeks, 15 weeks, 19 weeks and 71 weeks after start of the treatment. In the current project     patients will be assessed a 6th time 2 years after treatment completion.      The main study hypotheses are:        -  DBT will be significantly more efficacious in reducing the number of self-harm episodes          with or without intent to die, as well as reducing the number of emergency room visits          for self-harm or suicidal behaviour, compared to EUC.        -  DBT will be significantly more efficacious in reducing the level of suicidal ideation          and depressive symptoms compared to EUC.   "
129262|NCT01593189|"     This study focuses on children entering kindergarten with co-occurring developmental     disabilities and behavior problems, a population especially likely to have low levels of     school readiness. Prior research has shown that children with developmental disabilities are     at risk for academic difficulties. Behavioral and social problems are likely to interfere     with school adjustment. The investigators hypothesize that children who receive the     intervention will show better school readiness and school adjustment outcomes.   "
129263|NCT01593176|"     The investigators are doing this research study to look at how distal femoral fractures (knee     bone break) heal. In this study, the investigators will use Radiostereometric Analysis (RSA)     to look at how the pieces of femur bone move as the bone heals. RSA is a special x-ray that     uses radiographs to measure very small movements in the bone over time. The question that     will be answered by this study is whether RSA can be used as a tool to monitor fracture     healing.   "
129264|NCT01593163|"     Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it     has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA     treatment according to the last version of the Cochrane review. Nowadays the best dose     regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized     controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen     treatment versus standard treatment could reduce the number of doses of ibuprofen without     increasing the reopening rate and reducing the side effects associated to this medication.   "
129265|NCT01593150|"     Atrial fibrillation (AF) is the most common arrhythmia present in 1% of population under 60     years of age and reaching up to 15% at 80 years. AF is associated with reduced quality of     life, increased morbidity, mortality and health economic costs.      Presentation of AF differs substantially among patients ranging from self-limiting short     episodes (paroxysmal AF), longstanding episodes (persistent AF) where direct current (DC)     cardioversion is needed, to chronic atrial fibrillation. Treatment of AF is individually     tailored in accordance to symptoms, type of AF and thromboembolic risk. The standard     treatment of symptomatic persistent AF is DC-cardioversion preceded by anticoagulant     treatment with Warfarin. According to guidelines DC-cardioversion can be performed when     anticoagulation treatment has been in therapeutic range for at least 4 weeks. However     introduction of Pradaxa (Dabigatran) has enabled an earlier DC cardioversion, reducing time     to cardioversion to a 3 week period. During anticoagulation treatment persistence of AF     contributes to left atrial remodeling and increases in inflammatory and neurohumoral     biomarkers. The prolonged duration of AF and the remodeling of the left atrium increase the     risk of AF recurrence after DC-cardioversion.      Early cardioversion of patients with persistent AF is possible if preceded by transesophageal     echocardiography (TEE). The TEE guided DC- cardioversion, as demonstrated in the ACUTE study,     is a safe and efficient alternative to conventional treatment. This treatment regime is not     routinely used in clinical practice.      The aim of this study is to compare early DC-cardioversion (within 72 hours) to conventional     treatment (Pradaxa prior to DC-cardioversion). 140 patients with persistent AF will be     randomized to early cardioversion preceded by TEE in accordance with guidelines or     conventional treatment with Pradaxa for 4 weeks prior to DC-cardioversion.      The investigators will determine the outcome in the two groups regarding:        -  Left atrial function and size assessed by left atrial strain, left atrial ejection          fraction and left atrial volume.        -  Inflammatory and neurohumoral biomarkers including ANP, BNP,IL6 and CRP.        -  Time to recurrence of AF (AF documented by ECG or Holter monitoring)      Comprehensive transthoracic echocardiography, 12 lead ECG, biomarkers and Holter monitoring     will be performed at the time of randomization, 4 weeks, 3 month and 6 month post     DC-cardioversion. Furthermore all patients will be followed for symptomatic AF recurrence for     a period of one year. AF recurrence will be documented by 12 lead ECG.   "
129266|NCT01593137|"     The process of atherosclerosis is multifactorial and involves many mechanisms. The majority     of published works have identified endothelial dysfunction as the first step in a cascade of     events that culminates in plaque formation. Among the various mechanisms that occur following     the attack on the vessel wall, it is thought that stem cells in the form of endothelial     progenitor cells (EPCs) are the endothelial protection mechanism.      Factors identified as cardiovascular risk factors, or rather those conditions which suppose a     threat to the vessel wall, should therefore be associated with low levels of EPCs. To date     this link has been shown in hypertension, diabetes, hyperlipidaemia, and smoking.     Furthermore, the lack of wall protection in situations of low levels of EPCs is clearly a     biomarker of cardiovascular morbidity and mortality.      On the other hand, the correction of a risk factor allows recuperation of EPCs and is     therefore showing itself to be a promising tool for measuring therapeutic efficacy.      The tools for correcting EPC levels are not clearly defined. The effect of statins on levels     of EPC has been shown, and the low levels of EPCs in diabetes seem to be susceptible to     treatment with statins.      The role of glucagon-like peptide (GLP-1) is slowly being elucidated but the actual mechanism     of its potential endothelial protection is unknown, and its effect on EPCs has not been     studied.      Liraglutide, a long-acting GLP-1 analogue, could also be an interesting option for long-term     vessel wall protection, but to date its ability to correct cardiovascular biomarkers such as     EPCs has not been studied.   "
129267|NCT01593124|"     This study investigates the response of vaginal and cervical tissue after exposure to three     vaginal products: hydroxyethyl cellulose (HEC) placebo, nonoxynol-9 (N9) and imiquimod (IMQ)     cream.   "
129268|NCT01593111|"     Exposure to household allergens is a major contributor to asthma symptoms. Aggressive     measures to reduce household allergens has the potential to reduce asthma symptoms and the     need for medications to control asthma. The investigators plan to enroll patients aged 6 and     above into a single blind, randomized study comparing intensive environmental intervention     with usual asthma care over a 48 week study period. All subjects will have asthma treatment     optimized according to guideline based care. Subjects will be randomized to an aggressive     environmental remediation arm versus distribution of written materials regarding allergen     reduction (usual care). Primary outcome measure will be ability to reduce asthma step     therapy. Secondary outcomes include measures of lung function, asthma biomarkers and quality     of life.   "
129273|NCT01593046|"     LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety,     tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a     long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to     3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or     subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone for     2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months. For     the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be given     alone. Three dose levels of GSK1265744 will be evaluated partly in combination with TMC278 LA     to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability, and PK     profile. A total enrolment of approximately 40 healthy subjects is planned for this study.   "
129274|NCT01593033|"     The purpose of this study is to investigate the therapeutic effectiveness of micronutrients     (full RDA) and micronutrients + fish oil as separate interventions in restoring normal gut     absorptive and immunological function as measured by the dual sugar permeability test and     additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental     Enteropathy.   "
129275|NCT01593020|"     The goal of this clinical research study is to learn if and how well eribulin, given in     combination with standard chemotherapy, can treat early-stage breast cancer compared to     paclitaxel given in combination with standard chemotherapy. In this study, the standard     chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called     FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).      Eribulin is a changed version of the structure of a natural substance from a sea sponge. It     is designed to block cells from dividing, which may cause cancer cells to die.      Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.      5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or     stop their growth and spread throughout the body. This may cause the cancer cells to die.      Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop     their growth and spread throughout the body. This may cause the cancer cells to die.      Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.      Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may     slow or stop their growth and/or keep them from spreading throughout the body. This may cause     the cancer cells to die.   "
129276|NCT01593007|"     Objectives: To evaluate regional lung ventilation distribution in patients suffering from     chronic heart failure (CHF) after completing inspiratory muscle training (IMT) and correlate     it with functional capacity and quality of life among these individuals. Methods and Results:     Nineteen CHF patients were randomly assigned to two groups: Control and IMT. Before and after     muscle training, subjects were submitted to assessment protocol for respiratory muscles,     digital spirometry, optoelectronic plethysmography (OEP), the six-minute walk test (6MWT) and     a quality of life questionnaire (MLHFQ). There was no difference in lung function following     the 12-week training period in either group. However, the IMT group showed an increase in     actual and predicted MIP, higher MLFHQ score and greater distance walked in the 6MWT, as well     as a reduction in the Borg scale after the 6 MWT in relation to the control. For the OEP, IMT     group members exhibited higher values for total chest wall volume (Vcw), abdominal rib cage     volume (Vrc,a) and abdominal volume (Vab) when compared to the control. Conclusions: For     patients with CHF, IMT proved efficient in improving muscle strength, functional capacity and     quality of life. The present study also analyzed the distribution behavior of lung volumes     for the thoracoabdominal system in this population, showing that larger abdominal rib cage     and abdomen volumes may result in more effective diaphragmatic contraction.   "
129277|NCT01592994|"     This grant involved the development, implementation, and assessment of the feasibility and     acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives     (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was     adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV     intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was     from their primary male partner (Raj et al. 2001).      Specific aims of this study are as follows:        1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with          demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use          with at-risk Indian wives.        2. To determine the feasibility and acceptability of RHANI Wives with at risk wives* in          India. A two-group cluster randomized trial will involve random assignment of 12          neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a          control condition (n=150). Intervention effects on the more proximal and likely safer          sex mediating outcome of marital communication for this feasibility trial will be          assessed via surveys at baseline and 3 month follow-up.      NOTE: Only 220 participants were able to be recruited into the study.      *At risk wives are defined as having a husband at higher risk for transactional sex based on     wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7     days) or partner violence perpetration   "
129278|NCT01592981|"     The purpose of this trial is to assess tolerability and efficacy of the Bortezomib,     Cyclophosphamide and Rituximab combination as initial therapy for previously untreated     patients with symptomatic Waldenstrom's macroglobulinaemia.   "
129279|NCT01592968|"     The goal of this clinical research study is to compare stereotactic radiosurgery to whole     brain radiation therapy in patients with 4-10 non-melanoma brain tumors.      Stereotactic radiosurgery is the delivery of focused, high-dose radiation given in a single     session to the tumors with a minimal dose given to uninvolved areas of the brain.      Whole brain radiation is the delivery of lower dose radiation to the entire brain given daily     over 2 weeks.   "
129280|NCT01592955|"     The purpose of this study is to evaluate the effectiveness and the safety of the     cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma     patients   "
129281|NCT01592942|"     This is a prospective, randomized multi-centre study to find out most safe, feasible,     painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh     fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein     operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to     conventional Lichtenstein technique.   "
129282|NCT01592929|"     In this study the possible changes in upper airway geometry induced by variations in the     characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory     imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects.      Different mouthpiece designs will be evaluated for each subject by using magnetic resonance     imaging (MRI) scans. The results will help to identify the influence of the height, width,     protrusion and resistance of the mouthpiece on upper airway geometry.      Pharyngometry profiles of all subjects, whilst inhaling through different mouthpiece     variants, in supine and upright position, will be completed.      A computed tomography (CT) scan and a cone beam computed tomography (CBCT) scan of the upper     airway will be taken to respectively compare the time dependence on 3D imaging with MRI and     to provide a 3D image in an upright position.      Dental impressions will be optically scanned to obtain a more accurate representation of the     oral cavity, mainly in MRI.   "
129384|NCT01591590|"     The purpose of this study is to assess whether in a population of patients with advanced     colorectal cancer for which no known effective therapy is available, measuring the     spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and     Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that     serial FDG PET-CT and Diffusion MRI are able to measure it.   "
129283|NCT01592916|"     The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have     shown that exercise improves body functions and/or symptom severity in most patients, but not     in all. About a third of patients with FM have been shown to have low levels of IGF-1. The     purpose of this project is to study individual and biological factors that interact with     outcomes of short-term (acute) exercise in FM.      Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy     age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer     bicycle exercise tests will be conducted in feasting patients, separated by one month. The     first exercise test is at a low and the second at a high intensity. Measurements comprise     blood test, pain rating and pain threshold, conducted before and after the test. The levels     of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health     status and pain.   "
129284|NCT01592903|"     The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC)     responsible for the formation and growth of leiomyomas using the Side Population method.   "
129285|NCT01592890|"     This single-center, open-label study will assess the excretion balance, pharmacokinetics and     metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive     a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled     RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up     to 15 weeks.   "
129286|NCT01592877|"     To verify the accuracy and reliability of the ultra wideband (UWB) non-contact breath rate     and heart rate monitor, ICU bedside monitor is used as the gold standard.   "
129287|NCT01592864|"     A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing     dentinal hypersensitivity over an eight week treatment period.   "
129288|NCT01592851|"     A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing     dentinal hypersensitivity over a two week treatment period.   "
129289|NCT01592838|"     This study aims to investigate whether a change in the pattern of hospitalisation was     observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change     in staff workforce availability was observed in paediatric wards over the last 6 years     (during a whole year or during specific time periods of the year) and if changes of any of     the variables measured during the observation period could be linked to the introduction of     rotavirus vaccination.   "
129290|NCT01592825|"     The improvement of the healing rates for breast cancer is based to an important part on the     consistent use of so-called adjuvant (supporting ) medicamentous therapies, including     chemotherapy. However this success has a price due to still inaccurate knowledge of the     individual risk of relapse: a high number of unnecessary therapies are applied     (over-therapy!). The invasion factors uPA (plasminogen activator of the urokinase type) and     PAI-1 (uPA inhibitor) were described extensively as strong and independent prognosis factors     with high clinical relevance for patients with node negative breast cancer. Compared to     clinical and pathological factors (further: traditional factors ) they show better     estimation of the relapse risk leading to an avoidance of redundant adjuvant chemotherapy and     may thus essentially contribute to the improvement of the quality of life in these women. In     this study we aim to evaluate, how large the portion of the patients with early, operable,     node negative breast cancer will be, in whom, by improved low-risk identification through     uPA/PAI-1, adjuvant chemotherapy can be omitted.   "
129291|NCT01592812|"     Stimulation of arterial inflow to the lower limb is important to obtain functional     improvement in peripheral artery diseased (PAD) patients with claudication. The clinical     effect of muscle stimulation to increase arterial inflow and the direct evaluation of the     regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in     PAD patients.      Fifteen adult patients with stable arterial claudication will participate. Recruitment will     be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope)     After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an     increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most     symptomatic side.      The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the     femoral artery, and near infra-red spectrometry (NIRS) on both sides.      Patients will be instructed to report eventual contraction-induced pain in the stimulated     calf.   "
129292|NCT01592799|"     This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed     influenza, and compare the clinical features, severity, complications, risk factors and     socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI)     and/or isolated fever, with or without laboratory-confirmed influenza.   "
129293|NCT01592786|"     The purpose of this study is to evaluate the safety and tolerability of memantine in     pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive     Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for     participation in a follow-up randomized withdrawal study.   "
129294|NCT01592773|"     The objective of this study is to evaluate the long-term safety and tolerability of memantine     in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive     Developmental Disorder Not Otherwise Specified (PDD-NOS).   "
129539|NCT01589549|"     A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy     for newly diagnosed acute graft versus host disease after bone marrow transplantation or     donor lymphocyte therapy.      It is hypothesised that mesenchymal stromal cell therapy will be superior   "
129295|NCT01592760|"     The air-Q Self-Pressurizing Intubating Laryngeal Airway (aILA SP) is a modification of the     air-Q Intubating Laryngeal Airway (aILA). Besides the i-gel, it is the only breathing tube     that sits above the vocal cords that does not require inflation of a cuff with air. The     purpose of this study is to compare the ability of the aILA-SP to maintain patency of a     patient's airway during general anesthesia with that of the aILA and i-gel devices. As a     measure of this ability, we hypothesized that the airway sealing pressures will be equal     between the aILA-SP and aILA, but superior when comparing the aILA-SP to the i-gel (i-gel     will be lower).   "
129296|NCT01592747|"     This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled,     randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or     Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The objective is to     evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo.   "
129298|NCT01592721|"     The incorporation of novel targeted therapies to radiation therapy is of particular interest     in head and neck cancer and may improve efficacy without significantly increasing toxicity.     The investigators hypothesize that the addition of a second EGFR-targeted agent that inhibits     EGFR at the intracellular level will improve the antitumor effect of standard radiation and     cetuximab. The goal of this study is to evaluate the safety, efficacy, and the biologic     effects in patients with locally advanced SCCHN of an antisense gene targeting the EGFR in     combination with standard therapy with radiation and cetuximab.   "
129299|NCT01592708|"     The purpose of this study is to determine whether a multi-modal anesthesia and pain control     protocol reduces post-operative and post-discharge nausea and vomiting (PONV and PDNV) in     patients undergoing upper jaw corrective surgery.   "
129300|NCT01592695|"     The proposed work is designed to help increase access to tobacco cessation services among     rural veterans and to develop more effective treatment services that better address comorbid     issues commonly experienced by rural smokers. The objectives are:        1. Study the feasibility of an individually-tailored telephone intervention for rural          smokers.        2. Examine the impact of the intervention on tobacco use outcomes.        3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers          including depressive symptoms, alcohol use, and weight gain.   "
129301|NCT01592682|"     This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a     smoke-free educational intervention or self-help control group. The smokefree educational     intervention includes group education about smokefree environments and smoking cessation,     follow-up phone calls, and tobacco exposure lab reports. The control group is referred to     usual care with local in-language smoking cessation classes or quitline, and is otherwise     assessment only. The investigators hypothesize that pairs in the intervention group will have     higher rates of tobacco cessation and elimination of smoke exposure, compared to the control     group.   "
129302|NCT01592669|"     Background:      The pneumatic tourniquet is frequently used in total knee arthroplasty. Tourniquet deflation     may result in hypotension and tachycardia caused by the rapid shift of blood volume back to     the ischemic limb and a decrease in cardiac preload. Passive leg raising (PLR) represents a     self-volume challenge that can result in an increase in preload. Such a PLR-induced     increase in preload was hypothesized to attenuate the decrease in preload resulting from     tourniquet deflation. This study was designed to evaluate the effect of PLR on hypotension     and tachycardia following tourniquet deflation.      Methods:      Seventy patients who underwent unilateral total knee arthroplasty were assigned to either the     bilateral PLR group (n = 35) or the control group (n = 35), in a prospective randomized     trial. The patients' blood pressure and heart rate were measured before, during, and after     tourniquet deflation.   "
129303|NCT01592656|"     In this multicenter study the comparison of the mass flow distribution and redistribution     versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q)     matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will     be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore     a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with     non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan     will be used for FRI.   "
129304|NCT01592643|"     The purpose of this research is to determine if an investigational thin shield over the     cornea can safely and effectively reduce or eliminate pain following Post Photorefractive     Keratectomy (PRK).      The thin shield is made of silicone. The materials used to make the corneal shield all have a     history of use in medical devices, contact lenses, and/or corneal shields and have been used     safely in the eye.   "
129315|NCT01592487|"     This study is designed to test how breakfast affects brain function, memory and learning in     healthy children.      Hypotheses: Based on the results of our initial study and the relevant literature, it is     hypothesized that arousal, attention, and performance will be:        1. Greater in those who eat breakfast relative to those who do not;        2. Greater in lean than in overweight children receiving the higher protein breakfast;        3. Greater in fasting lean than fasting overweight children; and        4. Improved following a morning snack in all study groups.        5. Poorer in children with higher stress-related measures (e.g., higher cortisol levels).        6. Heart rate will be lower in fasting relative to fed participants, and across groups will          be higher in overweight children.   "
129316|NCT01592474|"     The purpose of this study is        -  To examine if Avaonex can delay the development of clinically definite multiple          sclerosis.        -  To investigate if Avonex can delay disability progression by slowing brain atrophy.   "
129329|NCT01592305|"     This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study     will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered     with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in     healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral     doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2,     all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study     treatment is up to 20 days.   "
129317|NCT01592461|"     The purpose of the study is to conduct a follow-up of substance abuse patients (n=1,269)     about 2 to 5 years since they were originally recruited from 8 substance abuse treatment     clinics (located in 5 states) to participate in a prior clinical trial study called START     (Starting Treatment with Agonist Replacement Therapies). The START Follow-up Study will be     conducted over 5 years and will involve three follow-up interviews with START participants.      The specific aims of the START Follow-up Study are as follows.        1. To determine longer-term outcomes of Suboxone versus methadone treatment received in the          START        2. To investigate patient and treatment factors associated with post-START treatment          access, utilization, and outcomes among Suboxone and methadone patients        3. To explore other correlates of the long-term outcomes among START patients.   "
129318|NCT01592448|"     The purpose of this study is to evaluate, through brief, one-on-one cognitive interviews, the     efficacy of 'enhanced' acetaminophen messages and icons in improving consumer understanding     and use of prescription (Rx) and non-prescription (over-the-counter, OTC) acetaminophen     containing products compared to the current standard.   "
129305|NCT01592630|"     The control of postoperative pain has become a major issue in surgery awareness and it is     considered an important measurement of patient satisfaction. Improvements in pain relief,     including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to     the surgical patient. When pain is aggressively addressed, patients respond by recovering     faster.      The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting     local anesthetic wound infiltration has been widely recognized as a useful adjunct to     multimodal postoperative pain management. On that basis, a system that delivers a continuous     local anesthetic to the surgical wound was developed, and better pain control has been     achieved after several surgical procedures.      In patients undergoing abdominal procedures, such as colon resection, adequate pain control     remains an issue. It is known that innervation to the antero-lateral abdomen is provided by     sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the     transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been     described and has shown to be effective for immediate postoperative pain control.      Recently, the use of the On-Q pain relief system with catheters placed within the TAP has     been evaluated. Published results have shown significant improvement of pain control     (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more     coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of     prospective trials investigating the effectiveness of a continuous wound infusion with local     anesthetics after general surgery procedures the investigators sought to determine the     efficacy of this technique after laparoscopic colon resection procedures.   "
129306|NCT01592617|"     The investigators identified three cancer-testis antigens, as targets for cancer vaccination     against lung cancer. In this clinical study, the investigators examine using a combination of     three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor     effect of vaccine treatment for advanced non-small cell lung cancer patients.   "
129307|NCT01592604|"     Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common     fractures in the foot, frequently treated in fracture clinics and involving significant     resources. At present methods of treatment and follow up vary widely from no active treatment     to surgery, depending entirely on a treating doctor preference. There is no agreement on     simple, safe and reliable method of treatment. The investigators believe that vast majority     of these injuries heal well on its own without any specific treatment. By comparing two most     commonly used treatments the investigators aim to establish one simple, safe and reliable     mode of treatments. The investigators are going to evaluate functional results of these two     treatments in a short and longer time prospective, by using the best available scientific     tools. The investigators believe that results of the investigators study will eventually lead     to change of practise and more efficient NHS care for these patients. It will reduce     unnecessary treatments and clinic appointments, and bring substantial savings to the NHS in a     long prospective.   "
129308|NCT01592578|"     The purpose of this study is to evaluate the efficacy of two different endoscopic treatment     in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus     sclerotherapy in addition to cyanoacrylates   "
129309|NCT01592565|"     This study is being done to demonstrate a powerful new method for detecting heart disease     that combines the proven prognostic capability of exercise stress testing with the superior     image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to     demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to     exercise stress SPECT for detecting obstructive artery disease.   "
129310|NCT01592552|"     The purpose of this research project is to collect and store blood samples and clinical data.     Researchers can then use the stored samples in future studies. Through such studies, they     hope to find new ways to detect, treat, and maybe even prevent or cure health problems.   "
129311|NCT01592539|"     The effects of high serum glucose on bone could be direct or could be indirect through its     effects on the microvasculature. Previous studies by Rendell et al and Brugler et al have     found significant differences in skin blood flow between diabetics and control. The     investigators are proposing that blood flow measurements of the skin may be correlated with     bone remodeling rates in iliac bone biopsies.   "
129312|NCT01592526|"     Critical illness, severe infection, extensive trauma or tissue damage cause an inflammatory     (irritative) reaction in the body. This reaction affects the whole body and causes malaise,     circulatory and cardiac changes, fever, increases the number of white blood cells in the     blood stream and prompts release of signaling proteins. This reaction contributes to the     development of considerable organ damage and possibly organ failure. These are serious     complications in critical illness which are associated with a high mortality. This     inflammatory reaction is affected by the autonomic nervous system. This is the part of the     nervous system, which is beyond the control of the free will, and the part that regulates     circulation, breathing and digestive functions. The autonomic nervous system works via     so-called sympathetic signals, which set the body in a state of alertness to overcome     immediate challenges, and parasympathetic (vagal) signals, which are especially active during     restitution and rest. It is known, that the balanced activity in the autonomic nervous system     affects the body's inflammatory response in critical illness. A study in mice has shown that     if parasympathetic (vagal) signals are blocked mortality in critical illness is increased.     Reversely, when the autonomic nervous system is medically stimulated towards parasympathetic     signaling, the magnitude of the inflammatory response is decreased. Nicotine exerts this     stimulatory effect.      Also, we know that individuals in good physical shape have increased parasympathetic tone     compared to less trained individuals. However, studies have never addressed whether this     shifted balance in the autonomic nervous system affects the inflammatory response related to     critical illness.      Over the last 30 years an experimental model mimicking the inflammatory response has been     used in studies. Inflammation may be simulated by injecting the drug E.Coli LPS, which     induces a controlled, fully reversible, harmless reaction the duration of which is a few     hours. Influenza-like symptoms occur and changes in circulatory parameters and concentrations     of signaling proteins can be measured.      Using this experimental model, the investigators wish to study whether this shifted balance     in the autonomic nervous system in individuals in good physical shape affects the body's     reaction to critical illness. Investigators also want to determine how nicotine (using a     nicotine patch) affects this reaction.   "
129313|NCT01592513|"     In this research, the investigators will asses the effect of BIS monitoring on propofol usage     during elective flexible fiberoptic bronchoscopy.      The investigators will examine whether use of BIS monitor enables reduction of sedative dose     during bronchoscopy.      The investigators will also examine whether administration of lower total sedative dose     enables prevention of possible complications.   "
129314|NCT01592500|"     This is a phase II, open label, active-controlled, randomized safety and dose finding study     of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth     hormone deficient children.   "
129330|NCT01592292|"     This prospective, multi-center, observational study will evaluate the efficacy and the safety     of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or     have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera     or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be     collected for 12 months.   "
129320|NCT01592422|"     The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not     been confirmed. Many treatment modalities like chemotherapy, interferons and other biological     agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A     marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha,     however, the functioning status and immune system may get worse, which subsequently has a     negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced     killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune     response and altering the interaction between tumor and its host. This effect may result in     improved tumor control and survival, as well as a better quality of life. To test the     hypothesis, a randomized controlled study was conducted to compare CIK cells with best     supportive care as maintenance therapy for SCLC.   "
129321|NCT01592409|"     Motor vehicle collisions are the leading cause of death for young people. The investigators     have recently found that driving after using cannabis is more common among young Canadian     drivers than driving after drinking. While this observation raises concerns, the effects of     cannabis on driving-related skills in this age group are not well understood. As well,     evidence suggests that residual effects of cannabis on driving-related skills may be observed     up to 24 hours later. These residual effects may have important implications for the effects     of cannabis use on collision risk, but little evidence on them in available. This study will     examine the effects of a single dose of cannabis (marijuana) on driving-related skills     immediately following consumption, 24 hours later, and 48 hours later. To date, the residual     effect at 48 hours has not been examined. A total of 142 subjects aged 19 to 25 years old     will be randomly assigned to smoke either a placebo or active cannabis cigarette (12.5% THC     potency). Following an eligibility screening and practice session, participants will attend 3     testing days; drug-administration, 24-hour follow-up and 48-hour follow-up. The effects of     cannabis/placebo on performance of driving-related skills using a high-fidelity driving     simulator will be assessed on each testing day. The effects of cannabis on mood, cognition,     memory and complex reaction time will also be assessed. Identifying factors that affect the     collision risks experienced by young drivers is a public health priority. While many young     people believe that cannabis does not impair driving, some recent studies suggest that these     may be very dangerous beliefs. This study will provide important information on how cannabis     may affect the driving skills of young drivers, to inform efforts to understand and address     cannabis-related collision in this age group.   "
129322|NCT01592396|"     The pharmacokinetic (PK) profile of tralokinumab (CAT‐354) will be studied in adolescent     subjects with asthma.   "
129323|NCT01592383|"     The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people     with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer.     Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other     cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This     research is being done because there is no current standard treatment for malignant     peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant     peritoneal mesothelioma.   "
129324|NCT01592370|"     The purpose of this study is to determine the side effects of treatment with Nivolumab by     itself or in combination in patients with relapsed/ refractory lymphoma or multiple myeloma.   "
129325|NCT01592357|"     Cardiac exercise rehabilitation consists of walking and bicycling activities. As the     population requiring rehabilitation is aging, other forms of exercise may be useful and     better tolerated. Tai Chi has been used for centuries, is easy to perform even by more     debilitated individuals, and promotes improvement in blood pressure, fitness, and relaxation.     Tai Chi may be more beneficial for frail cardiac patients because it is especially suited for     the unfit and elderly, and can be practiced anywhere. Further studies are required to assess     this form of exercise in cardiac patients. The objective of this randomized controlled study     is to compare the effects of Tai Chi to sham exercise training in 200 frail cardiac     patients who have completed six months of cardiac rehabilitation and are 60 years of age or     older. Participants will be randomized to Tai Chi or sham exercise training and have their     gait speed, blood pressure, heart rate, exercise capacity, balance, quality of life and     cognitive function assessed before and after 24 week of training.   "
129326|NCT01592344|"     The purpose of this study is to investigate whether the StimRouter (SR) electrical     stimulation therapy leads to clinically important pain relief in patients with chronic     intractable pain of peripheral nerve origin after three months of treatment. At the same     time, this study will gather information on side effects associated with the StimRouter     electrical stimulation therapy.   "
129327|NCT01592331|"     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the     pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.      Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or     placebo. In-unit period is 6 days.   "
129328|NCT01592318|"     This randomized, open-label, crossover study will evaluate the relative bioavailability of     ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc     combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects     will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an     FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a     crossover design, subjects will participate in 3 study periods with at least a 7-day washout     between periods. In Part 2, single dose administration of film-coated FDCs will be compared     to reference tablets.   "
129331|NCT01592279|"     The new incretin-based therapies offer appealing advantages over existing drugs. Aside from     glucose dependent insulin secretion and a proven glucose lowering efficacy, they have other     concomitant beneficial effects, such as low risk of hypoglycemia, inhibition of the glucagon     secretion with maintenance of counter-regulatory mechanism, promotion of weight loss, and     possible cardiovascular benefits (improvement of lipid profile, blood pressure, endothelial     and myocardial function). The glucose lowering effects resulting from the inhibition of     glucagon secretion and the gastric emptying rate could be of clinical importance in type 1     diabetes.      The rationale behind the use of GLP-1 analogues in the treatment of type 1 diabetes relies on     the assumption that these drugs, in addition to their action on insulin secretion and glucose     regulation, may be effective in preserving and even expanding the β-cell mass. This class of     drugs may represent an entirely new approach to the treatment of type 1 diabetes, focused on     protection and preservation of β-cells. These therapies have the opportunity to interfere     with the disease progression if used as an early intervention, when enough β-cell mass/     function can still be preserved or restored.      Hypothesis:      GLP-1 analogue (liraglutide) will improve glycemic control as measured by HbA1c in     uncontrolled type 1 diabetic patients. The investigators expect a reduction of 1% in HbA1C     from baseline.   "
129332|NCT01592266|"     PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a     precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution.     Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic     disease either in bone marrow or extramedullary.      F18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as     well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive     study can replace bone marrow biopsy and predict response vs. non response to therapy.   "
129333|NCT01592253|"     For patients who meet the inclusion criteria and who agree to participate in this study, the     investigators sampled peripheral blood 10cc and performed the analysis for immunologic     profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year     from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha     analysis fo immune profile again. During the study period, the interval of the visit of     subclinic and the kinds of laboratory test (Blood and urine test) would not change compared     to before the start of this study.   "
129334|NCT01592240|"     To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615     administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with     high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.   "
129335|NCT01592227|"     A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an     adjuvant from two different paracetamol formulations.   "
129336|NCT01592214|"     This is a Phase I, multi-center, clinical study of XF-73 to evaluate the local (nasal) safety     and tolerability of a modified, thinner lower viscosity formulation of intranasal XF-73 in     healthy male and female subjects. In addition, the potential for systemic absorption of XF-73     in the modified, thinner lower viscosity and the previously investigated thicker, higher     viscosity formulations and their decolonization efficacy in comparison to placebo will be     evaluated. Both parts of the study will be double-blinded and Part 2 will also be     placebo-controlled. Primary objective is to establish the safety and tolerability of two     concentrations of a modified thinner, lower viscosity nasal formulation of XF-73 and to     compare them to a previously investigated, thicker, higher viscosity formulation   "
129337|NCT01592201|"     The purpose of this study is to compare the patient satisfaction between continued     administration of previous antipsychotics versus switched administration to paliperidone ER     in non-satisfied patients with previous (paliperidone)   "
129338|NCT01592188|"     This project will explore the effect of Cognitively-Based Compassion Training or mindfulness     training on behavior and saliva stress hormones in elementary school-age children.   "
129339|NCT01592175|"     The tight relationship between attention and conscious perception makes them difficult to     study in isolation and has led many scientists to closely link these two processes. However,     while some authors argue that conscious perception cannot occurs without attention,     magnetoencephalography (MEG) and fMRI studies had shown that attention and consciousness are     two distinct brain processes.      If endogenously triggered attention and consciousness are dissociated, it has been proposed     that orienting of exogenous attention is a necessary, though not sufficient, antecedent of     conscious perception.      In the present study we used MEG to explore the neural correlates of exogenous attention and     consciousness during visual processing.   "
129340|NCT01592162|"     The objective of this study is to evaluate the influence of different propofol formulations     (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is     administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.   "
129341|NCT01592149|"     The study is an epidemiological survey to find out the incidence of loss of appetite in     Indian patients suffering from various health disorders. This survey will be conducted to     obtain information on appetite from a total of 17500 subjects This study does not intend to     study the effect of any drugs. The primary source of information will be the subjects     themselves. The study will be conducted at 275 - 350 centres spread across India.This is a     single visit study.The physician will conduct routine clinical, physical and general     examination.   "
129342|NCT01592136|"     This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic     myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic     leukemia (Ph+ALL) who have failed all available treatment options.   "
129343|NCT01592123|"     The aim of this report was to assess the frequency of poor sleep quality, daytime and dream     anxiety and their response to subsequent surgical treatment for a representative group     patients with nasal septum deviation.   "
129344|NCT01592110|"     This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three     doses of risperidone-SABER, administered with a needle and syringe or via the DosePro     Needle-Free Delivery System in patients with chronic, stable schizophrenia.   "
131037|NCT01569841|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     compare the efficacy of insulin decludec with insulin glargine on glycaemic control using     continuous glucose monitoring in patients with type 1 diabetes.   "
129345|NCT01592097|"     Gilenya (fingolimod) is approved for multiple sclerosis. However, it is unclear of its     clinical effect in the Hispanics with MS given that clinical studies had limited     representation of this population. It is also unclear if Gilenya would be as effective in     individuals with disease predominantly affecting the optic nerve and spinal cord (OSMS)     commonly seen in Asian populations.      Objectives: To compare the clinical response of Gilenya® (fingolimod) in relapsing remitting     OSMS and MS of Hispanic descent using ancestral markers as a biomarker of treatment response     and clinical disease state.   "
129346|NCT01592084|"     The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis     (ALS) pathophysiology and its impact on disease progression and survival is unclear. The     investigators analyzed the correlation between lipid levels with disease progression and     survival in ALS patients and the association of LLT with these outcomes.   "
129347|NCT01592071|"     This study assessed the effect of an IgG-mediated food sensitivity test in combination with a     food elimination diet on body composition and secondary outcomes in people who were     overweight.   "
129348|NCT01592058|"     The purpose of this study is to learn whether women who use progestin-only methods of birth     control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS     (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared     to women using the non-hormonal copper IUC (ParaGard).      The investigators primary hypothesis is that users of DMPA will gain excess weight and     increase their BMI above the copper-IUC users; secondarily, the investigators will compare     users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.   "
129349|NCT01592045|"     The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of     chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or     the National Cancer Institute [NCI]).   "
129350|NCT01592032|"     The antibiotic lock technique (ALT) is used as local treatment for Catheter-Related     Bacteremia (CRB). It consists in the administration of a concentrated antimicrobial solution     with a calculated volume to fill the lumen of the catheter. The lock solution is indwelled     within the catheter for a defined period of hours or days before been removed.      Currently, the Infectious Diseases Society of America (IDSA) Guidelines for treatment and     management of CRB, recommends to change the antibiotic solution every 24 hours.      The investigators expect to determine the stability of the concentration of vancomycin,     teicoplanin, linezolid, daptomycin and tigecycline used in lock solutions, and thus to assay     the optimal timeframe that the concentration of antibiotic used in lock solution keeps its in     vivo antimicrobial activity.      Study Hypothesis: An antibiotic lock solution maintains in vivo concentration and     antimicrobial activity for at least 10 days after its infusion inside a subcutaneous port     catheter.   "
129351|NCT01592019|"     The investigators hypothesize that a technique called microdialysis can be used to measure     the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin.     Microdialysis uses a small device called a 'probe' to determine the amount of drug which     enters a body tissue. The small device is placed directly in the fatty tissue and samples are     taken at specific times. The investigators will determine whether site of application affects     the availability of the drug.   "
129352|NCT01592006|"     Patients are being asked to be part of this study because they are a liver transplant     recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver     transplant patients includes taking two medications called pegylated interferon alfa-2a     (Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment     of HCV.      This study will evaluate the safety and efficacy of adding a third drug called telaprevir for     the experimental treatment of HCV in liver transplant patients. The combination of Pegasys,     ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is     specifically not FDA approved for HCV patients who have had a liver transplant. This is     because more information is needed about possible drug interactions between telaprevir and     cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are typically     part of routine care for transplant patients.      Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys     and ribavirin for the treatment of HCV. However, these studies did not include adequate     information on transplant patients due to the potential drug interactions.      The investigators hope to gather more information about the safety and efficacy of telaprevir     given in combination with Pegasys and ribavirin in the liver transplant patients who have HCV     that is not well controlled with Pegasys and ribavirin alone.   "
129353|NCT01591993|"     Sensitive skin syndrome is a frequent self-diagnosed entity that has not been previously     described in a Latin-american population. One hypothesis to its development is an alteration     of the barrier function of the skin. The aim of the study is to describe the frequency of     sensitive skin in a mexican population detected through the lactic acid test, and to explore     its response through biophysical measures (colorimetry, transepidermal water loss (TEWL) and     capacitance). The prevalence of this syndrome in studied populations is approximately 50%.     Considering racial skin differences, the investigators would expect at least a 20%     prevalence.      For this purpose, the investigators would need a minimum of 243 healthy volunteers, 18 years     or older, with previous informed consent, to whom the lactic acid test will be performed. The     investigators will record any unpleasant sensation graded in a Visual Analog Scale (VAS) of     10 points, colorimetry, TEWL and capacitance before the test and at 3, 5, 8 and 10 minutes     after the lactic acid test.   "
129354|NCT01591980|"     Objective: To compare the incidence of chronic pain at 3 months among adults undergoing     craniotomy between those received two different doses of pregabalin and those receiving     placebo.   "
129355|NCT01591967|"     The purpose of this randomized controlled trial (RCT) is to measure the effects of specific     thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both     normotensive and hypertensive humans.   "
129378|NCT01591668|"     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and     activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up     visits are also required periodically through day 43. Study procedures involve taking blood     samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.   "
129356|NCT01591954|"     Current standard of care for complex head, neck and skull base surgery require navigation     systems that allow instruments to be tracked optically or electromagnetically while     registered to a patient's pre-operative X-ray computed tomography (CT) or magnetic resonance     image (MRI). However, conventionally, the CT/MRI data is not registered with video endoscopy.     Augmentation of endoscopic video by preoperative data can facilitate navigation around     critical structures and robust target resection. The work presented here describes evaluation     of a high definition (HD) video-overlay system for endonasal endoscopic skull base surgery.     We adopt a modular design that can be extended for other video augmentation applications. The     system supports fast automatic camera calibration, comparable in re-projection errors to     standard camera calibration tools, while performing within appropriate run time for clinical     use. Phantom studies have shown the registration accuracy of the system to be equivalent to     that of conventional optical tracking. With this system we are proposing a clinical pilot     study in a small number of patients at Johns Hopkins Hospital to evaluate basic feasibility     and to gather qualitative assessment of the video augmentation system.   "
129357|NCT01591941|"     There is a large number of young women who sustain serious knee injuries from playing soccer.     Female athletes are at high risk of knee injuries from soccer than males. We will conduct a     research project to assess the effect of a warm-up on changing some of the movement patterns     thought to contribute to these serious knee injuries.      It is hypothesized that a core position and control movement strategy (Core-PAC) group reduce     biomechanical risk factors at the knee compared to a control after the training program.   "
129358|NCT01591928|"     Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along     the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly     associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA).     Advances in cardiac surgery have improved HS mortality such that there is increasing     attention to IRA and their management. The objective of this research project is to     prospectively observe a cohort of infants with HS and IRA and evaluate their long term     outcomes. Specifically, the investigators would like to determine what is the natural history     of asymptomatic IRA in patients with HS and what is the morbidity and mortality secondary to     an elective Ladd procedure for asymptomatic IRA in a population with HS? The investigators     plan a prospective, multi-center, observational study to follow this complicated group of     patients. This will be a web-based database collected from major cardiac tertiary care     centers in both Canada and the United States. Patients with HS will be recruited by their     primary site and clinical data will be collected by their primary site prospectively     throughout childhood until they are at least five years of age. This patient population will     be followed by their own clinical care givers; this is not an interventional study. No     additional clinic visits will be required and the patients will not have to be contacted.     Patient medical records will be accessed by a member of the study team at the primary site at     least once per year or more frequently if interventions are required or complications     develop.   "
129359|NCT01591915|"     The purpose of this study is to evaluate the effect of mindfulness based stress reduction     intervention in women with breast cancer   "
129360|NCT01591902|"     To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of     Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and     Type 2 diabetes mellitus (T2DM).   "
129361|NCT01591889|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Tinidazole 500 mg Tablet under fed conditions.   "
129362|NCT01591876|"     The aim of this study is to evaluate whether a three month intra-dialytic exercise programme     improves arterial function.   "
129363|NCT01591863|"     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of     fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).   "
129364|NCT01591850|"     This randomized, single-center, open-label, one-sequence, two-period crossover study in three     parts will assess the effects of multiple doses of ketoconazole, rifampicin and     ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy     male and female volunteers. In Period 1, subjects will receive a single oral dose of     RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple     oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated     time on study is up to 8.5 weeks.   "
129365|NCT01591837|"     This is a study to assess the immune (antibody) response and safety of the 2012/2013     formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or     older.   "
129366|NCT01591824|"     Through this research is to conduct a pilot clinical trial in the treatment of chronic     nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that     will apply a technique of physiotherapy by passive movement of the column with oscillations     in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called Pold     Concept), another group that applies the standard protocol of treatment for this condition,     as used in the hospital where performed the study.      It will compare the levels of efficiency and effectiveness of each treatment and the     comparison between them. This will measure the perception of pain intensity and disability.   "
129367|NCT01591811|"     1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy          and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute          toxicity that is not significantly worse than that of a concurrent cohort of patients          treated with IMRT randomly assigned to a weekly or daily boost regimen.        2. To test the hypothesis that when prone, patients treated with 3D-CRT breast          radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed          develop late toxicity that is not significantly worse than that of concurrent cohort of          patients treated with IMRT randomly assigned to a weekly of daily boost.        3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be          achieved in each of the two randomized arms, for either technique tested.   "
129368|NCT01591798|"     After introducing minimally invasive surgery, robotic surgery has been increasingly used in     colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of     this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low     rectal cancer.   "
129369|NCT01591785|"     Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In     adults, eczema commonly localizes to the hands or feet. Several studies have implicated     bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor in     atopic dermatitis, as infection with this bacteria correlates with disease severity. No trial     to date has investigated how to treat S. aureus infection in adults with hand or hand/foot     dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet, the     investigators expect to have a significant clearance rate of s. aureus infection. The     investigators believe that treating the bacterial infection along with treating the condition     with a topical corticosteroid will significantly decrease the severity of hand/foot     dermatitis in our study population.   "
129416|NCT01591161|"     The objective of this clinical study is to compare the safety and efficacy of mapracorat     ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation     and pain following cataract surgery.   "
132336|NCT01552811|"     This study investigates the hypothesis that differences in beta-cell mass in patients with     diabetes and healthy individuals can be monitored by the positron emission tomography (PET)     tracer [11C]5-hydroxytryptophane.   "
129370|NCT01591772|"     The purpose of this study is to learn about possible changes in brain anatomy and function,     and in thinking abilities, such as memory skills, in patients with ovarian cancer who receive     treatment with chemotherapy. Cancer patients treated with chemotherapy may experience changes     in thinking abilities, and these may interfere with quality of life. Most of the research to     date has involved patients with breast cancer, and there are no studies in women with ovarian     cancer looking at at treatment-related changes in brain anatomy and function.   "
129371|NCT01591759|"     This investigation will explore the impact of 8 weeks of citicoline treatment on cognitive     function, clinical state and substance use in 40 individuals with mild traumatic brain injury     (mTBI).   "
129372|NCT01591746|"     Each year, the number of breast cancer survivors who choose post-mastectomy breast     reconstruction keeps rising. Among women who elect to pursue breast reconstruction,     approximately 75% will choose prosthetic breast reconstruction. Implant-based breast     reconstruction is frequently achieved in two-stages. The first stage consists of the     placement of a tissue expander after mastectomy. This is followed by a period of biweekly     tissue expansions that can last several months. In the second stage, the tissue expander is     removed in a surgical procedure and replaced with a permanent breast implant. Tissue     expansion is a well-established breast reconstruction technique characterized by high success     rates and high patient satisfaction. Despite the well-recognized advantages of this     successful breast reconstruction technique, the subpectoral placement of a tissue expander is     associated with significant pain and discomfort in the immediate post-operative period and     during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported     problem during tissue expansion. Legeby et al. recently showed that women who underwent     prosthetic breast reconstruction had higher pain scores and took more analgesics that those     who did not choose post-mastectomy reconstruction.      In the past 10 years, publications on the use of BTX-A for pain relief in a wide array of     clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by     Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has     both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought     to be related to its effects on muscular contraction. However, a recent in vitro study of     embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a     neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic     properties of BTX-A is increasingly supported by several clinical observations: pain relief     with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic     tennis elbow, and post-operative pain control for lower limb lengthening correction, among     others.      This aspect has never been studied in breast cancer survivors who elect to pursue breast     reconstruction with tissue expanders. Furthermore, physical function outcomes are important     to consider with BTX-A use because the link between temporary muscle paralysis and     improvements in participation in daily activities is not a given.      The investigators propose to complete a double-blinded prospective randomized controlled     trial of women undergoing unilateral and bilateral mastectomies with immediate placement of     tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in     improving physical well-being during the expansion period.   "
129373|NCT01591733|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of a therapy to learn whether the therapy works in treating a specific cancer.     Investigational means that the therapy is still being studied and that research doctors are     trying to find out more about it-such as the safest dose to use, the side effects it may     cause, and if therapy is effective for treating different types of cancer. Proton beam     radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery     system.      Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as     it delivers less radiation beyond the area of the target tissues. This may reduce side     effects that patients would normally experience with standard (photon) radiation therapy,     which tends to include more normal tissue along with tumor target tissue.      Researchers in the laboratory have discovered that there are pathways inside the cells that     can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and     capecitabine are targeted towards blocking the pathways that allow cancer cells to divide,     and may result in the tumor shrinking in size.      In this research study, the investigators are looking to determine if proton beam radiation     in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of     your cancer.   "
129374|NCT01591720|"     A tailored Internet-based cognitive-behavioural intervention is tested within a primary care     clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant     within-group effects are expected.   "
129375|NCT01591707|"     The purpose of this study is to test the effectiveness of a school-based treatment aimed at     increasing language and social skills in preschool-aged children with autism spectrum     disorder (ASD). Through interactive development (continually seeking educator feedback for     intervention improvement) and implementation of the intervention, the investigators hope to     provide a feasible and practical means for educators to work with children with ASD in real     world, large scale settings. ASD preschool educators, the children enrolled in their classes,     between the ages of 3 and 6 years and their families may join.   "
129376|NCT01591694|"     Trauma-informed treatment will improve emotional regulation and behavior.   "
129377|NCT01591681|"     The purpose of this study is to see whether low blood sugar at night can be reduced by using     a system that turns off the insulin pump automatically. The study system includes a     combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and     a regular laptop computer that runs a computer program that predicts low blood sugar. It     works by (1) measuring the glucose levels under the skin with a continuous glucose monitor,     (2) using a computer program on a laptop to predict what will happen to the glucose level     over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program     predicts that low blood sugar will occur.      This study has several phases and will take about 3 months for a patient to complete.     Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure     that they are able and willing to use this system and to determine if they meet the     investigators study criteria to proceed with the next phase of the study. Patients will be     provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic     CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is     able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most     recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to     complete the CGM run-in phase will have an extra office visit for training.      If eligible to continue in the study, patients will need to use the study system for 5 nights     at home so that the investigators can make sure they are able to use it correctly. After     that, patients will be asked to use the study system each night for an additional 6 to 8     weeks. If the system is active and predicts that a patient's blood sugar will become low, the     insulin pump will shut off for up to 2 hours.      The study will include about 45 individuals at 3 clinical centers in the United States and     Canada.   "
129379|NCT01591655|"     The objective of this clinical study is to compare the safety and efficacy of mapracorat     ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation     and pain following cataract surgery. Participants from the United States and Canada will be     recruited for this study.   "
129380|NCT01591642|"     The main purposes of this study are: (1) to investigate the difference of the physical     fitness, and quality of life (QOL) among different physical activity levels in post-coronary     artery bypass graft (CABG) patients; (2) to analyze the relationships between physical     activity and physical fitness and QOL in this population. The investigators predict physical     activity and physical fitness remain limited in patients after CABG, and patients with higher     physical activity levels will have higher QOL and physical fitness.   "
129381|NCT01591629|"     The purpose of this project is to examine the effects of mu-opiate antagonism on the     rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main     psychoactive ingredient of cannabis.   "
129385|NCT01591577|"     The purpose of this study is to test the safety and effects of a combination of a study drug,     Lapatinib, plus the administration of standard radiation therapy and an FDA approved drug     Temozolomide (chemotherapy agent) in patients with newly diagnozed glioblastoma     Multiforme.Currently, only radiation therapy and Temozolomide chemotherapy are standard     treatment for brain cancer.Lapatinib has not been FDA approved for use in brain tumors     treatment. It has been approved to be used as a daily treatment with other chemotherapies by     the FDA for the treatment of advanced breast cancer.      The purpose of this study is to find the answers to the following research questions:        1. Is Lapatinib given twice a week at higher dosages, with radiation therapy and          Temozolomide, safe when given to patients with brain tumor?        2. What are the side effects of Lapatinib given twice a week at higher dosages when given          with radiation therapy and Temozolomide and how often do they occur?        3. Can Lapatinib, radiation, and Temozolomide be effective in shrinking tumors when given          to patients with brain tumors?        4. To determine whether the presence of genetic alterations specific proteins in the tumor          samples can predict whether this study drug is effective on the tumor.   "
129386|NCT01591564|"     The purpose of this study is to determine the feasibility and acceptability of an utilizing     an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for     Depressed Adolescents, for youth with severe mood dysregulation (SMD).      The investigators hypothesize that retention rates will be >80%,satisfaction scores will     average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD     intervention will have overall improvement in SMD symptoms.   "
129387|NCT01591551|"     The purpose of this study is to assess the impact of Natalizumab (Tysabri) therapy on sleep     efficiency, total sleep time and sleep latency, in Multiple Sclerosis (MS) patients receiving     Natalizumab for 6 months relative to baseline.   "
129388|NCT01591538|"     Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative     bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6     months outside France.   "
129389|NCT01591525|"     The purpose of the type II diabetes (T2D) screening study is to improve diabetes care in     minority communities by identifying undiagnosed and uncontrolled T2D patients, as well as     help patients without a regular primary care physician (PCP) find one within their community.     These goals will be achieved first through a glucose measurement. Individuals with a high     glucose measurement will be confirmed with a rapid hemoglobin A1c (HgA1c) test. The HgA1c     test will tell us about the patients average blood sugar over the past 3 months, which will     allow us to immediately diagnose new and uncontrolled type II diabetics. All participants     will fill out a survey on healthcare seeking behaviors before glucose testing. All patients     who enter the study will receive education on T2D and the value of regularly visiting their     PCP, and will be provided a list of PCP currently accepting new patients within a 3 mile     radius. Follow-up visits at 4 and 8 months will help us determine the success this community     based screening.      The investigators hypothesis is that community based screening designed with adequate     education and follow-up, and performed by qualified medical professionals will improve     diabetes care in minority communities as assessed through hemoglobin A1c levels over 8     months, and in the change in the number patients who visit/obtain their PCP within the study     period.   "
129390|NCT01591512|"     The purpose of this study is to collect samples to evaluate the ProGRP and NSE assays     independently as aids for monitoring the course of disease and therapy in subjects diagnosed     with SCLC.   "
129391|NCT01591499|"     This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare     the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses     allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a     ratio of 1/0.5), in presbyopic patients.   "
129392|NCT01591486|"     Low-dose aspirin (ASA) has emerged as the most important cause of peptic ulcer bleeding     worldwide. In western countries, ASA has overtaken non steroidal antiinflammatory drugs     (NSAIDs) as a major cause of peptic ulcer bleeding in the elderly population [1,2].     Management of peptic ulcer bleeding in patients receiving ASA for cardiothrombotic diseases     is a clinical dilemma. In a randomized trial of continuous versus interrupted ASA therapy     after endoscopic treatment of peptic ulcer bleeding, patients who discontinued ASA had a     10-fold increased incidence of all-cause mortality compared to those who received continuous     ASA therapy. On the other hand, patients receiving continuous ASA therapy had a two-fold     increased risk of early rebleeding [3]. Thus, preventing the occurrence of peptic ulcer     bleeding in ASA users is important in reducing morbidity and mortality.      Given the uncertain clinical utility of Helicobacter Pylori (Hp) testing in ASA users, this     prospective cohort study aims to determine whether testing for Hp will have any impact on the     long-term incidence of ulcer bleeding in ASA users with high ulcer risk. The investigators     hypothesize that among ASA users with Hp infection and ulcer bleeding, the long-term     incidence of recurrent ulcer bleeding with ASA use will be low after eradication of Hp alone.   "
129394|NCT01591460|"     This open-label, multicenter, treatment response guided study will evaluate the sustained     virological response and safety of the triple combination therapy boceprevir, Pegasys     (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with     genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual     combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination     therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be     administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment     response. The anticipated time on study treatment is up to 48 weeks.   "
129395|NCT01591447|"     To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the     treatment of uncomplicated urogenital gonorrhea.   "
129396|NCT01591434|"     Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such     it is anticipated that through improved exudate management a longer wear time will be     achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic     wounds such as venous leg ulcers.   "
129397|NCT01591421|"     For the first phase of this study (phase I), the purpose will be to find the dose of a new     drug, BKM120, that can safely be given in combination with standard dose panitumumab.      For the second phase of this study (phase II), the purpose is to find out what effects the     combination of BKM120 and panitumumab, in doses found to be safe in the first part of the     study, has on patients and their colorectal cancer.   "
129398|NCT01591408|"     The proposed study, Placebo-controlled study of EEG biofeedback therapy as an adjunct     treatment for PTSD, evaluating symptoms and EEG dynamics, will investigate the brain     dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or     sham EEG biofeedback in addition to treatment as usual at the Naval Medical Center, San Diego     (NMCSD) OASIS program.      EEG biofeedback treatment protocols for PTSD and other disorders have been developed and     honed by private practice clinicians over the past 25 years, during which EEG biofeedback has     become an increasingly popular adjunct therapy.      The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy     warrants a clinical study investigating not only symptom reduction, but also the underlying     neurobiological mechanism. To this end, we propose a study using high density EEG recordings     before and after treatment for PTSD symptoms to determine which brain activities correlate     with reported symptom changes.      The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG     biofeedback is shown to improve symptom reduction over the placebo controlled condition, it     would offer a non-pharmacological intervention that would avoid undesirable side effects, and     accelerate recovery compared with the current standard of care.   "
129399|NCT01591395|"     Inguinal hernia is one of the most common surgical diseases. Over the past years, the safety     and feasibility of laparoscopy was established and gaining popularity in recent few years.     Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter     recovery period, earlier return to normal daily activities and work, and better cosmetic     results. The laparoscopic hernia repair usually require three working ports ranging from 5 to     10 mm. However, with each increasing laparoscopic ports usually associated with possible     increasing morbidity and pain related to ports.      Efforts are continuing to further reduce the port related morbidities and improve the     cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of     ports. This has led to the evolution of a novel surgical approach now collectively known as     laparoendoscopic single site surgery. LESS has been performed for variable indications     including extirpative and reconstructive urologic procedure via the transperitoneal approach.     Early experience has demonstrated the feasibility as well as the safe and successful     completion of these LESS procedures. Although these initial reports are promising, the     clinical advantages of LESS procedures over conventional laparoscopic procedures have not     been defined. Therefore, we conducted a single center, randomized trial to compare the safety     and other outcomes after conventional laparoscopic and LESS inguinal hernia repair in adult     patients.   "
129400|NCT01591382|"     Patients who are dependent on opioids often have poor pain relief after major surgery. This     study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of     intravenous opioids for postoperative pain will improve pain relief in this subset of     patients.   "
129401|NCT01591356|"     The goal of this clinical research study is to learn about the safety of siRNA-EphA2-DOPC     when given to patients with advanced, recurrent cancer. Researchers also want to learn the     highest tolerable dose of this drug that can be given.      siRNA-EphA2-DOPC is designed to shut down the activity of a genetic biomarker called EphA2.     Biomarkers are found in the blood and tissue and may be related to your reaction to the study     drug.      You are being asked to take part in this study because you have advanced cancer that is     recurrent (has come back).   "
129402|NCT01591343|"     Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides     pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or     rhinoconjunctivitis with or without asthma.      Primary variable: number of subjects [%] who experienced at least one immediate or delayed     systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.   "
129403|NCT01591330|"     The study will evaluate the effect of different particle size of LY2140023. The study     involves four single doses of 80 mg LY2140023 taken as 1 tablet by mouth with a washout     period of at least 3 days between doses. This study will last approximately 60 days not     including screening. Screening is required within 30 days prior to study entry.   "
129404|NCT01591317|"     The purpose of this study is to investigate how the body processes prasugrel and how     prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of     prasugrel will be given. Information on side effects will also be collected.   "
129405|NCT01591304|"     This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.   "
129462|NCT01590563|"     Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion,     malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is     inserted in a similar fashion into the uterus and takes a three dimensional spherical shape     while curving away from the fundus. Apart for an anticipated reduction in the rate of stated     complications, its smaller size and mallable characteristics are also expected to improve     user experience. The clinical trial is intended to evaluate the safety and initial efficacy     of this novel device.   "
129406|NCT01591291|"     Heavy drinking can cause serious health, family, and economic problems. Finding treatments     that are effective in decreasing heavy drinking among alcohol-dependent individuals is,     therefore, an important scientific and health goal. A novel and important strategy to enhance     alcoholism treatment efforts uses a personalized medicine approach to optimize treatment     effects by selecting the right patient therapeutically and potentially with a minimum of     adverse events, for a specific medication.      This study will extend findings from a randomized double-blind clinical trial of ondansetron,     in which the medication was found to reduce drinking among individuals with certain genotypes     (i.e., forms of DNA, the material that controls the inheritance of characteristics). The     proposed study will address a number of limitations in the prior work, including testing the     medication in both European-American and African-American samples.   "
129407|NCT01591278|"     The objective of the study is to evaluate and compare, clinically and radiographically,the     effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human     primary molars.   "
129417|NCT01591148|"     This study will determine how morbid obesity affects the distribution and metabolism of the     drug propofol. The investigators hypothesize that propofol will be distributed and     metabolized differently in morbidly obese subjects as compared to normal weight subjects.   "
129408|NCT01591265|"     This clinical trial investigates relative benefits (clinical effectiveness and quality of     life) of two extraction patterns when lower first permanent molars (FPM) are extracted in     children: the conventional treatment where current guidance is followed and extraction of the     upper FPM is carried out, compared with the intervention where there is no compensation     extraction of the upper FPM following extraction of the lower FPM.      Study objectives: To determine whether compensating extraction of upper FPMs following loss     of lower FPMs in children is of benefit. The particular benefits being investigated are     related to the resulting occlusion, patient experience and oral health related quality of     life. The follow up will extend over a period of 5 years or until the patient is 14 years of     age - whichever is earlier.   "
129409|NCT01591252|"     In a group of HIV-positive patients under observation since their first exposure to ART or     monitored off of ART, BMD changes over one year will be determined. For each subject, the     investigators will also determine associations between changes in BMD and 1) ART initiation,     2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated     through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a},     high-sensitivity c-reactive protein {hsCRP}).      Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of     ART, after excluding those subjects treated with tenofovir.      BMD will decrease most significantly in HIV-positive subjects with the highest levels of     cumulative viremia.      HIV-positive persons with highest cumulative viremia will have the highest levels of     inflammation, as measured by pro-inflammatory cytokines.      Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare     sample and fracture association with the use of varying ART medications among dual-eligible     persons in Medicare and Medicaid datasets.      Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to     HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest     duration of ART exposure.   "
129410|NCT01591239|"     This project is aimed at parents with a teenager who is already starting to use drugs. The     study will test a new, innovative version of a brief intervention. This program will be home     based rather than implemented by a counselor in a clinical setting. The stage I activities     will involve manual development, parent training development, and a small feasibility study;     Stage II involves an efficacy study. Two samples, 110 families each, will participate in the     trial. Families will be assigned to either an intervention or control condition. The     investigators hypothesize that the home-based intervention will be superior to the control     condition. In addition, the investigators expect response to the intervention by the     adolescent to be mediated by motivation, cognitions, problem solving, peer drug use,     parenting skills and parent self-efficacy.   "
129411|NCT01591226|"     A positive ergogenic effect of sodium citrate and caffeine ingestion in a short-term,     high-intensity exercise task was shown by several studies. These studies were conducted with     healthy, able-bodied subjects.      The aim of the study is to investigate whether caffeine or sodium citrate ingestion could     enhance performance in spinal cord injured wheelchair athletes. It is a double blind, placebo     controlled and randomized study.   "
129412|NCT01591213|"     -The St. Jude Cancer Education for Children Program was created in 2006 as part of the     outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research Hospital.     The curriculum is designed to teach schoolchildren about cancer and dispel common     misconceptions, inform students about healthy lifestyle choices that can translate to reduced     cancer risk in adulthood, and to inspire an interest in science and scientific careers. In     the 2010-2011 school year, researchers examined the impact of the program in regard to     knowledge.      It has always been clear that St. Jude personnel are limited to visiting a small number of     schools in person each year so in 2011, a teacher's kit to the education program was created.     The kit includes all the lesson plans needed to complete the program without the presence of     St. Jude staff members. As a result, researchers at St. Jude Children's Research Hospital     want to test the feasibility of the intervention by schoolteachers, and how this mechanism of     delivery will affect student knowledge, attitudes, and health behaviors associated with     cancer and healthy living.   "
129413|NCT01591200|"     This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with     cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in     various parameters will be observed over 2 years.   "
129414|NCT01591187|"     Exposure to secondhand smoke is a leading preventable cause of child morbidity and mortality,     and the adverse health consequences of secondhand smoke are magnified among youngsters with     cancer and sickle cell disease. Current methods for measuring secondhand smoke exposure     (SHSe) rely on retrospective reports over extended time periods that are subject to recall     errors and systematic inaccuracies in reporting and often do not include the youngster as the     primary informant. These methods may underestimate the extent of cumulative SHSe and are not     well suited to capturing exposure over time and across settings where young people frequent.     More appealing methods that engage youngsters to better monitor tobacco smoke in their     environment are warranted.      The study will examine the feasibility of cell phone texting to obtain measures of secondhand     smoke exposure (SHSe) in children treated for cancer or sickle cell disease (SCD).   "
129518|NCT01589822|"     The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin     Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.   "
129415|NCT01591174|"     The purpose of this research is to see if there are differences between children who have FD     and children without FD in the ability of the stomach to empty food and/or in ghrelin hormone     levels before and after eating.      Chronic abdominal pain is the most common persistent pain condition in children and     adolescents. One of the most often diagnosed types of abdominal pain is functional dyspepsia     (FD). FD is abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that     does not get better by having a bowel movement.      One possible explanation for having FD is a delay in the emptying of food from the stomach,     or delayed gastric (stomach) emptying. Failing to empty the stomach quickly enough may result     in the feeling of being full and cause symptoms of bloating, nausea, vomiting and pain.     Further, hormonal changes occur before, during, or after eating food that appear to impact     stomach emptying.      One of the hormones that changes with meals is called ghrelin. The relationship between     ghrelin and stomach emptying needs to be explored more in children with FD. Better     understanding of what causes FD symptoms may help us to improve treatment for this condition.   "
129418|NCT01591135|"     The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has     better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients     with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into     this study.   "
129419|NCT01591122|"     The purpose of this study is to demonstrate the safety and effectiveness of abiraterone     acetate when co-administered with prednisone in patients with chemo-naive metastatic     castration resistant prostate Cancer (mCRPC).   "
129420|NCT01591109|"     Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the     effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with     metastatic liver tumors derived from colorectal cancer.      Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon     bevacizumab cessation in the clinical setting is lacking.      Methods: The study included 10 patients who received chemotherapy including bevacizumab,     experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently     underwent liver resection. CEUS was performed before and immediately after 4 courses of     chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34     antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As     a control, 10 surgical specimens from 10 patients who had not received chemotherapy were     examined.   "
129421|NCT01591096|"     Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and     dose-finding study of intravenous (IV) tPA in children with acute ischemic stroke (AIS) to     determine the maximal safe dose of intravenous Tissue Plasminogen Activator (IV-tPA) among     three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset of     acute AIS.   "
129422|NCT01591083|"     Patients with comorbidities have an increased risk of ulcer re-bleeding, especially within     the 14 days after first bleeding event. Three-day high dose esomeprazole infusion can prevent     peptic ulcer rebleeding after endoscopic therapy. However, the optimal dose of oral     esomeprazole is uncertain, especially for high risky patients. This study is to test whether     a double dose of oral esomprazole could reduce peptic ulcer rebleeding for patients with     Rockall score ≥ 6. Additionally, the second aim of this prospective study was to identify the     selection criteria to predict poor fading and residual major stigmata of recent hemorrhage     (SRH) or early recurrent bleeding after successful endoscopic hemostasis and high-dose PPI     infusion.   "
129423|NCT01591070|"     The purpose of this study is to determine whether proactive use of 0.1% tacrolimus ointment     once or twice weekly can keep adult facial SD in remission and reduce the incidence of     exacerbation.   "
129424|NCT01591057|"     This study will examine what contribution of 'markers' of fruit and vegetable (FV) intake in     blood and urine is most closely related to FV intake. 30 healthy volunteers will be fed     either 2, 5 or 8 portions of FV per day for 4 weeks (ten participants per group, randomly     assigned). Volunteers will have all their food provided during the study, and will consume     two meals each weekday at the University. Volunteers will complete diet and lifestyle     questionnaires at the start and end of the study and will have blood and urine samples     collected at 0, 2 and 4 weeks.   "
129425|NCT01591044|"     The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in     the treatment of mild to moderate asthma.   "
129426|NCT01591031|"     Anesthesia induction with sevoflurane is not associated with an increased incidence or     severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.   "
129427|NCT01591018|"     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual     transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of     brain infarctions due to the activation of endogenous fibrinolytic system during cardiac     surgery (CS). 120 patients indicated for CS (CABG or valve replacement) will be enrolled into     the study in order to demonstrate a twenty-percent risk reduction of number and volume of     brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of     significance. Patients will be randomized - subgroup 1 will undergo a 40-240minute     non-diagnostic TCD monitoring during CS, subgroup 2 will undergo interventions without TCD     monitoring.      The aim of the project is a concordance with the aim No 1 of the Resort Program of a Research     and Development: Improvement of quality of life of patients using the modern therapeutic     methods but with relative small positive effect of quality of life. The aim of the project     is in concordance with a priority of announced public grant competition: Development of the     new therapeutic methods of cardiovascular disorders, especially coronary heart disease and     stroke. Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous     fibrinolytic system during CS with consecutive reduction of the number and volume of brain     infarcts, can lead to the increase of the safety of CS in patients. We can presume that up to     50% of patients indicated for CS can be treated using these methods in the future.   "
129428|NCT01591005|"     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual     transcranial Doppler monitoring) using 2 MegaHertz (MHz) diagnostic probe on the reduction of     risk of brain infarctions due to the activation of endogenous fibrinolytic system during     carotid endarterectomy (CEA) and carotid stenting (CS). 240 patients indicated for CEA (120     patients) and CS (120 patients) will be enrolled into the study in order to demonstrate a     twenty-percent risk reduction of number and volume of brain infarctions detected using MRI     examination 24 hours after CEA or CS in 5% level of significance. Patients will be randomized     - subgroup 1 will undergo a 60minute non-diagnostic transcranial Doppler (TCD) monitoring     during CEA or CS, subgroup 2 will undergo interventions without TCD monitoring. The second     aim is to compare number of brain infarctions detected using MRI between CEA and CS patients.      Confirmation of the investigators hypothesis that sonothrombolysis is able to activate     endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and     volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients     with internal carotid artery stenosis. The investigators can presume that up to 50% of     patients indicated for CEA or CS can be treated using these methods in the future.      In the Substudy Risk of brain infarction after carotid endarterectomy and stenting the the     risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as     well as morbidity and mortality at 30 days between patients with symptomatic and asymptomatic     severe internal carotid artery (ICA) stenoses undergoing elective CEA and CAS will be     compared.      The sample size of the Substudy was based on an expected 80% difference of new ischemic     lesions on DWI-MRI between CEA (estimated prevalence, 30%) and CAS (54%). Pre-study     calculations showed that a minimum of 73 patients in each group was needed to reach a     significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8     assuming that 15% of subjects would be lost to follow-up or refuse to participate in the     study.   "
129429|NCT01590992|"     The purpose of this study is to determine whether psychotherapy (based on exposure     techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform     Disorders (as exemplified here in subjects with globus sensations in the throat).   "
129431|NCT01590966|"     In this open-label monocentric explorative pilot trial the objective is to show the     biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active     rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is certolizumab     pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for     TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of this study is to     show the TNFα triggered inflammation process in the inflamed joints, especially in patients     who have very early joint damage where currently other imaging methods such as X-rays are not     sensitive enough for detection.   "
129432|NCT01590953|"     Ochsner employees with a body mass index (BMI) greater than or equal to 30 will be enrolled     in a fitness program consisting 90 days of a structured exercise program and dietary     counseling. Measures of fitness including weight, BMI, cholesterol, HDL, blood pressure, and     absenteeism rates will be measured at 0, 90 days, in one year.   "
129433|NCT01590940|"     The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability     in the number and composition of meshes currently on the world market. The use of     biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These     selected polymers have the ability to degrade while implanted, allowing for sufficient     natural tissue healing and scarring. This usage presumably favors a decrease in foreignness,     inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with     similar plug meshes in the same indication have yielded favorable results which require this     mesh to be investigated in its specific application.      Primary Objective      Evaluate the incidence of peri-operative and post-operative complications after the     application of the Parietex plug and patch hernia system in open inguinal hernia repair. We     will assess the efficacy of this mesh by examination and the application of a pain scale at     the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended     to evaluate:        -  Patient report of pain via their Pain score        -  Wound complication        -  Incidence of chronic groin pain        -  Recurrence rate        -  Other complications Secondary Objectives      Record the description and assessment of the Parietex plug and patch hernia system:        -  surgical technique        -  description of dissection and mesh placement        -  method of fixation        -  operative times, anesthesia choice        -  length of hospital stay        -  mesh handling characteristics        -  return to daily activities        -  overall patient satisfaction   "
129434|NCT01590927|"     Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic     Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, & Galea, 2005). The hypothesis     is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an     equal or even more precise way. The TrakSTARTM will have the advantage to be used in     measuring functional movements. In this Master thesis the hypothesis is to show a good     reliability by trampoline jumping (physical activity).   "
129435|NCT01590914|"     Utilizing fMRI, this study will examine changes in BOLD signal as a proxy measure of brain     activation in response to highly palatable (high energy density [kcal/g]), less palatable and     non-food stimuli in severely obese women pre, 1 month post and 3 months post undergoing     bariatric surgery (in surgery patients) and at equivalent times for control groups in fed and     fasted conditions at each time point.      Two surgical groups: (i) laparoscopic Roux-en-Y gastric bypass (RYGB) and (ii) gastric     banding (GB) will be compared with two control groups: (i)those enrolled on a 3-month formula     weight loss program or (ii) those who qualify, but do not undergo bariatric surgery, and     receive no weight loss treatment.   "
129436|NCT01590901|"     The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral     doses of probucol in healthy male subjects.   "
129459|NCT01590602|"     The study aims to monitor the progression of symptoms and signs of those affected by JHD     using modified UHDRS scales of motor and function (functional assessment, TFC). This will     provide some basic data to analyse the usefulness of the proposed rating scales.     Specifically, the initial aim is to assess these rating scales using an iterative process.      There may be significant delays in diagnosis of JHD especially if the young person presents     with behavioural problems. Caregivers will be asked questions to capture the number of     contacts with professionals in the time between onset of concerns about the young person and     the confirmation of diagnosis.      Aim is to monitor the progression of symptoms and signs of those affected by JHD using     modified UHDRS scales of motor and function (functional assessment, TFC). This will provide     some basic data to analyse the usefulness of the proposed rating scales.   "
129540|NCT01589536|"     The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological     interval-intervention, combined with a structured follow up, decreases the rate of disability     retirements caused by psychosocial co-morbidity of patients with coronary heart disease.   "
129437|NCT01590888|"     Huntington disease (HD) is an inherited neurodegenerative disease which affects over 30,000     people in both the United States and Australia. HD is characterized by brain cell death that     usually begins between the ages of 30 to 50, and results in motor, cognitive and behavioral     signs and symptoms. While there are medications to help relieve some of the disease symptoms,     there is no known treatment to address the cognitive impairment associated with HD.      Normally occurring metals in the brain play a significant role in diseases such as Alzheimer     disease and HD. PBT2 is a drug designed to interrupt interactions between these biological     metals and target proteins in the brain, to prevent deterioration of brain cells. PBT2, has     shown in animal models, and as well as in a small group of patients with Alzheimer's disease,     it may improve cognition. There is some indication in animal models of HD, that the drug may     improve motor function and control and reduce the amount of brain cell degeneration.      PBT2-203 will evaluate how safe and well tolerated PBT2 is at a dose of 100 mg or 250 mg a     day administered as oral daily capsules compared to a placebo over a six month treatment     period. The trial will also measure whether there is an effect on cognitive abilities as well     as other HD symptoms including motor and overall functioning of individuals with HD.   "
129438|NCT01590875|"     Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins     during atrial fibrillation ablation, however, the methodology has not been validated either     in terms of the reproducibility of the adenosine response or the effect on clinical outcomes,     namely whether using pulmonary vein reconnection to guide additional ablation lowers rate     recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response     to adenosine used in this manner is reproducible over time.   "
129439|NCT01590862|"     The primary aim of this study is to test the effects of excitation of ventral striatal     circuitry via DBS (e.g. DBS-on versus DBS-off) on reward motivation. The investigators     predict that stimulation will increase subject willingness to expend effort for rewards and     facilitate motivation for reward learning. The investigators further predict that individual     differences in the effects of DBS on reward motivation as will be associated with effects of     DBS treatment on anhedonic symptoms.   "
129440|NCT01590849|"     The use of combined oral contraceptives has been associated with increased risk of adverse     cardiovascular events. The exact mechanism by which these drugs exert this influence is     uncertain. It is possible that changes in autonomic nervous system are involved. The     objective of these study was to evaluate the effect of the use of a contraceptive containing     20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in     healthy women. Few studies have been conducted in the field of hormonal contraception and     evaluation of the autonomic nervous system work and no prospective, controlled study was     published so far. These study will be the first.   "
129441|NCT01590836|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacodynamic response (the effect of the investigated drug on the body) of insulin     degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.   "
129442|NCT01590823|"     Patients with end stage renal disease carry a high risk for atrial fibrillation (AF) and     require oral anticoagulant therapy for prevention of stroke. Often, the oral anticoagulant,     warfarin sodium, is prescribed. Managing dialysis patients on warfarin can be fraught will     difficulties given the multitude of drug and food interactions, need for frequent coagulation     monitoring and dosage adjustment, and concern that warfarin enhances vascular calcification     in dialysis patients. Recently, dabigatran etexilate, a direct oral thrombin inhibitor, has     been approved for use in AF patients with normal renal function. Since many drugs are     eliminated by the kidneys and removed from the plasma during dialysis, it is important to     determine proper drug dosing in hemodialysis patients through evaluating pharmacokinetics.   "
129443|NCT01590810|"     This study will evaluate the safety and tolerability of MK-8150 and its effect on central     systolic blood pressure (cSBP) and heart rate corrected augmentation index (AIx) when given     as single oral doses in healthy males and in males with mild-to-moderate hypertension. A     primary study hypothesis is that post dose mean change from baseline of time-weighted average     across 24 hours (TWA0-24hrs) cSBP or AIx is reduced in participants administered MK-8150     compared to placebo in males with mild to moderate hypertension. A mean decrease from     baseline compared to placebo of ≥5 mm Hg in TWA0-24hrs cSBP or of ≥5 percentage points in     TWA0-24hrs AIx is considered clinically meaningful.   "
129444|NCT01590797|"     A study to compare safety and efficacy of sitagliptin and placebo therapy when added to     stable insulin alone or in combination with metformin in participants with type 2 diabetes     mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of     sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in     T2DM participants on insulin alone or in combination with metformin.   "
129445|NCT01590784|"     Depression in patients with schizophrenia is common. Several factors was found to be     associated with depression including medical illness, quality of life, positive symptoms, and     typical antipsychotics. The Calgary depression scale of schizophrenia (CDSS) is commonly used     for screening depression in schizophrenia,however; the Thai version of CDSS has not been     validated.      This study aims to a.) test the reliability and validity of the Thai version of Calgary     depression scale of schizophrenia (CDSS) and b.) identify the prevalence and factors     associated with depression in patients with schizophrenia including quality of life, type of     antipsychotic drugs, and severity of schizophrenia in 60 patients with schizophrenia at the     Faculty of Medicine, Chiang Mai University, Thailand.   "
129446|NCT01590771|"     A study to compare safety and efficacy of sitagliptin and placebo therapy when added to     stable sulfonylurea alone or in combination with metformin in participants with type 2     diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the     addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C     (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.   "
129447|NCT01590758|"     The purpose of this study is to establish the clinical superiority and the safety of topical     pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus     standard local wound care, in the treatment of mildly infected diabetic foot ulcers.   "
130606|NCT01575483|"     The purpose of this post-marketing surveillance is to investigate and confirm the type and     incidence of newly identified adverse events and any other factors affecting safety and     efficacy of Onglyza® so that the regulatory authority can manage the marketing approval     properly.   "
129448|NCT01590745|"     Carpal Tunnel Syndrome (CTS) is a recognisable pattern of symptoms and signs, which are     caused by compression of the median (middle) nerve as it passes through the carpal tunnel at     the wrist.      This condition affects individuals by causing pain, numbness, tingling sensations and     sometimes weakness in the fingers and may extend to shoulder and neck areas. The cause for     most cases is unknown (idiopathic) though some common conditions are associated with an     increased incidence, including obesity, pregnancy, hypothyroidism, arthritis, diabetes, and     trauma.      Diagnosis is primarily clinical and the condition is easily recognised from the     characteristic symptoms in straightforward cases but diagnostic support is provided by     investigations such as nerve conduction studies and ultrasound imaging.      Treatment may include splinting, local steroid injection at wrist, activity     modification,physical or occupational therapy (controversial), medications, and surgery.     Treatment with local therapeutic ultrasound has been suggested to be effective but existing     trials are inconclusive.      Wrist splinting is only partially effective with a success rate of 34%, Steroid injection is     followed by frequent relapses and there remains uncertainty about the safety of serial     injections. Surgery is effective but has a small but significant incidence of permanent     complications. Any demonstrably effective and safe addition to the therapeutic options would     be a significant advance in treatment. Therapeutic ultrasound at present appears a promising     option, having a very good safety record but so far uncertain evidence of efficacy.      In our trial patients, with mild carpal tunnel syndrome, confirmed by nerve conduction     studies, will all be given wrist splints so that no patients will be left untreated. They     will be randomly allocated to either therapeutic or sham ultrasound therapy (20 sessions over     7 weeks) and followed up for 1year. The patients, operators of the ultrasound equipment and     assessors will all be blind to treatment allocation.      The effect of treatment on symptoms will be assessed using a validated questionnaire and     nerve conduction studies will be repeated at completion of the ultrasound treatment, 6 and 12     months.      This study is designed to find out to whether therapeutic ultrasound is an effective     treatment for carpal tunnel syndrome (CTS).   "
129482|NCT01590303|"     This study is designed to determine if Vitamin C administration to septic patients will     result in an improvement in organ dysfunction which occurs during a septic illness.      Hypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce     the length of time on a ventilator, length of stay in the intensive care unit and in     hospital.   "
129449|NCT01590732|"     The goal of this clinical research study is find the highest tolerable dose of romidepsin     that can be given in combination with ifosfamide, carboplatin, etoposide (ICE) to patients     with PTCL. The safety of this drug combination will also be studied.      Romidepsin is designed to stop the growth of cancer cells and block new blood vessels from     forming around the cancer cells. This may cause the cancer cells to die.      Ifosfamide and etoposide are designed to slow or stop the growth of cancer cells.      Carboplatin is designed to interfere with the growth of cancer cells by stopping cell     division, which may cause the cells to die.   "
129450|NCT01590719|"     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the     efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with     metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients     will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in     combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo     until disease progression, unacceptable toxicity, patient or physician decision to     discontinue treatment.   "
129451|NCT01590706|"     -  Although aging process appears to be generally characterized, investigators have been          paid much attention to the specific target molecules, which leads to discover the          clinical markers of the senescence. The present study is to investigate the clinical and          biological profile of cognitive decline and functional cardiac senescence in healthy          middle aged and elderly Korean volunteers.        -  This study was conducted as a cross-sectional, single-center, comparative clinical          study.        -  Each volunteer was given informed consent for checking cognition and cardiac function.          Blood and urine samples were collected to analyze genome, proteome, and metabolome to          assess cognition and cardiac function of its muscle enzymes.   "
129452|NCT01590693|"     The purpose of this study is to determine whether botulinum toxin A (BTX) adds a favourable     effect to treatment of idiopathic toe-walking with below knee walking casts. The specific     hypothesis to be tested is that a combination of BTX and casting is more effective than     casting treatment alone in reducing toe-walking in 5-15 year old children. Evaluation methods     include 3-D gait analysis, parents' perception of toe-walking frequency, passive joint range     of motion measurements, and strength of ankle dorsal extension.   "
129453|NCT01590680|"     Primary Objectives:        -  Provide palliative therapy with 131I-MIBG for patients with advanced neuroblastoma,          pheochromocytoma, or paraganglioma.        -  Gain more information about acute and late toxicity of 131I-MIBG therapy for patients          with refractory neuroblastoma, pheochromocytoma, or paraganglioma.   "
129454|NCT01590667|"     The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy     subjects, to provide more comprehensive and robust clinical evidence in its mode of action     for the treatment of obesity and weight management through dietary fat binding.   "
129455|NCT01590654|"     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and     activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are     required periodically through day 43. Subjects with sustained reductions in HbsAg will be     requested to return for additional follow-up follow-up visits at 3 and 6 months post last     dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic,     and safety assessments   "
129456|NCT01590641|"     Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2     mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and     activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up     visits are also required periodically through day 43, and potential viral load follow-up     visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for     pharmacokinetic, pharmacodynamic, virologic, and safety assessments   "
129457|NCT01590628|"     Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a     UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells and a Second,     Unmanipulated CBU in Patients with Hemoglobinopathies.   "
129458|NCT01590615|"     This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of     follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of     liver decompensation, death, or conclusion of the registry.   "
129460|NCT01590589|"     This is a multi-centre, multi-national, prospective, observational study of Huntington's     disease (HD) with a control group of volunteers to:        -  obtain natural history data on many HD mutation carriers and individuals who are part of          an HD family        -  relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)        -  expedite identification and recruitment of participants for clinical trials        -  develop and validate sensitive and reliable outcome measures for detecting onset and          change over the natural course of premanifest and manifest HD which may also be          potential outcome measures for use in future clinical trials and clinical care        -  plan for future research studies   "
129463|NCT01590550|"     Providing hemodialysis requires the use of an extracorporeal circuit which must be     anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased     circuit blood flows, inefficient dialysis and even significant blood loss secondary to     circuit clotting.Heparin has been traditional agent used to provide anticoagulation. Heparin     has multiple adverse side effects that would be best avoided in acutely ill patients who are     at risk for bleeding. Alternative means of providing anticoagulation include citrate based     anticoagulation. Citrasate® is a heparin free anticoagulant alternative that has been FDA     approved since 1999 and readily available for commercial use since 2001. Citrasate® utilizes     citric acid instead of acetic acid for acidification; the presence of small amounts of     citrate in the dialysate also provides the means for anticoagulation. The concentration of     citrate is low (2.4meq/L) and thus has a minimal effect on serum calcium values. No calcium     monitoring or infusion is indicated.      The purpose of this study is to obtain further data on the use of Citrasate® in admitted     pediatric patients who receive hemodialysis as part of their therapy for acute kidney injury.   "
129709|NCT01587313|"     This is a single center, open-label, two-period study. There will be nine healthy human     volunteers arbitrarily assigned to one of four groups. The study objective is to compare the     action of various combinations of BiDil extended-release capsules and commercial BiDil     Tablets in the body over a period of time.   "
129464|NCT01590537|"     This is local prospective, non-interventional multi-center comparative study. Primary study     objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after     insertion ( patient assessment questionnaire) in daily practice. For each patient, the     treating gynecologist documents demographics, medical data, safety parameters and treatment     signs and symptoms at an initial visit and one or two follow-up visit(s).   "
129465|NCT01590524|"     The purpose of this study is to determine whether Guided Imagery and Progressive Muscle     relaxation are effective as stress reducing techniques in parents of hospitalized children     with cancer.   "
129466|NCT01590511|"     The main objective of this study is to show that the variation of the subaortic velocity time     integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is     predictive of response to filling (defined as an increase in aortic velocity time integral     measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline     over 15 minutes) in non-ventilated shock patients.   "
129467|NCT01590498|"     The purpose of the study is to determine whether radiotherapy improves cancer control and     overall survival among patients with Castration resistant prostate cancer.   "
129468|NCT01590485|"     The purpose of this study is to determine whether saffron is effective in the pain control     after root canal therapy in vital teeth.   "
129469|NCT01590472|"     The purpose of this research study is to investigate the possibility that a person's genes     put a person at a higher risk of developing mesothelioma. The investigators will examine     genes from DNA (genetic material) isolated from blood. This study will also examine the     impact of environmental and work exposures and family history of common cancers on the     development of mesothelioma. The genetic markers in this study will basically identify how a     person's body processes frequently encountered environmental pollutants and will not tell     about chromosomes, specific diseases, or other potential health problems.   "
129470|NCT01590459|"     This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor,     for treatment of subjects with active RA who have had an inadequate response to Methotrexate.   "
129471|NCT01590446|"     The purpose of this study is to measure how much of the study drug gets into the blood-     stream and how long it takes the body to get rid of it when given as a single dose.     Information about any side effects that may occur will also be collected.   "
129472|NCT01590433|"     The investigators are conducting a study that will investigate the possible mechanisms of     weight loss associated with exenatide treatment and the metabolic characteristics of high     responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment.     The investigators will also examine the magnitude and duration of weight loss among a cohort     of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment.      Hypothesis:      The mechanisms of weight loss with exenatide are not fully understood, and weight loss     responses to exenatide are highly variable, possibly reflecting distinct metabolic     parameters. By identifying and following a group of obese women who lose greater than 5% body     weight after short-term exenatide treatment, the investigators can gain insights into the     possible mechanisms of weight loss and assess long-term weight loss with this     pharmacotherapeutic intervention.   "
129473|NCT01590420|"     The purpose of this study is to estimate the cost-utility of continuous positive airway     pressure (CPAP) therapy in obstructive sleep apnea (OSA) patients in Sao Paulo city, Brazil,     after 3 years of treatment and to estimate the cost-effectiveness of CPAP on the number of     medical visits, hospitalizations, medical examinations, used medications, new case incidence     and cost of traffic accidents and absence from work. It is also designed to estimate     quality-adjusted extended years of life, and to assess cost-effects of the therapy (device,     masks, supplies, maintenance/year for membership of professional consulting, electric power)     on the cost-effectiveness   "
129474|NCT01590407|"     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,     tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers     (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.      Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will     assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing     pharmacokinetics and safety in subjects with CHC genotype 1 infection.   "
129475|NCT01590394|"     Plastic biliary stents which are a new larger size will remain free of obstructions for a     longer period of time than currently used 10 French stents in cancer in the common bile duct.   "
129476|NCT01590381|"     The purpose of this study is to assess HBV immunity and institute policy regarding the     Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during     infancy.   "
129477|NCT01590368|"     It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram     (ECG) trace is comparable between the two groups (marketed and test products) after 30     minutes (the intended period of use) of the electrodes.   "
129542|NCT01589510|"     A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT.     All treatment decisions, care and diagnostic procedures provided are at the discretion of the     participating physicians according to their clinical judgment and the local standard of     medical care.   "
129478|NCT01590355|"     The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx     is radiation therapy. Some patients require chemotherapy with the radiation, and some     patients require surgery if the tumour or lymph nodes have not responded after radiation.      This study will compare radiation therapy with a new surgical treatment called transoral     robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon     in removing the tumour, potentially with fewer side effects than older surgical techniques.   "
129479|NCT01590342|"     The primary objective is to demonstrate the clinical benefits of diclofenac (added to     standard anticoagulant therapy) over placebo in normotensive patients with acute symptomatic     pulmonary embolism and right ventricular dysfunction.      The secondary objective is to assess the safety after administration of diclofenac in     normotensive patients with acute symptomatic pulmonary embolism and right ventricular     dysfunction.   "
129480|NCT01590329|"     This case series will assess the use of suction blister epidermal grafts harvested by a novel     device on select patients with hypo pigmented skin or surgical skin wounds.   "
129481|NCT01590316|"     Background 25,000 infants are born extremely preterm every year in Europe. This group of     infants carries a high risk of death and subsequent cerebral impairment for the infant,     especially in the first 72 hours of life. Mortality is about 20%, and about 25% of survivors     live with either cerebral palsy or low intelligence quotient. Preventative measures are keys     to reducing mortality and morbidity in this population. There is evidence that the cerebral     oxygenation time spent out of range (time with hypoxia or hyperoxia) is associated with poor     outcome in infants. Near-infrared spectroscopy (NIRS) has been used to monitor tissue     oxygenation since the mid-1980s, and quantification of oxygenation (rStO2) in a percentage     from 0 to 100% has been possible for 10 years. From almost 400 preterm infants normal ranges     of rStO2 has been determined to be from 55% to 85%. Still, there are no clinical trials and     thus no solid evidence of the clinical utility of NIRS in preterm infants. Thus, research on     the benefits and harms of cerebral monitoring using NIRS as a part of clinical management of     premature infants is much needed.      Objectives The primary objective of the SafeBoosC trial is to examine if it is possible to     stabilise the cerebral oxygenation of extremely preterm infants during the first 72 hours of     life through the application of cerebral NIRS oximetry and implementation of an     rStO2-specific clinical treatment guideline. We hypothesise that by using the specified     treatment guideline to respond to cerebral monitoring readings outside the target range, we     would reduce the burden of hypo- and hyperoxia and consequently reduce brain injury.      Trial design This is an investigator-initiated randomised, blinded, multinational, phase II     feasibility clinical trial involving preterm infants from 12 European countries.      Inclusion criteria The inclusion criteria are: neonates born more than 12 weeks preterm     (gestational age up to 27 weeks and 6 days); decision to conduct full life support; parental     informed consent; and cerebral NIRS oximeter placed within 3 hours after birth.      Sample size With a 50% reduction of the area outside the normal range of oxygenation in     %hours in the experimental group compared to the control group as the minimal clinically     significant difference, a standard deviation of the area outside the normal range of 83.2     %hours, a type I error (alpha) of 5%, and a type II error of 0.05 (power of 95%) inclusion of     75 preterm infants in the experimental group and 75 preterm infants in the control group is     required. The inclusion of twins are likely to decrease power, so it has been decided to     increase sample size to 165 on a pragmatic basis of estimating intracluster correlation,     control event rate, and incidence of twin births.      Intervention The premature infants will be randomised into one of two groups (experimental or     control). Common is that both groups will have a cerebral oximeter monitoring device placed     within three hours after birth. In the experimental group, the cerebral oxygenation reading     is visible, and the infant will be treated accordingly using a defined treatment guideline.     In the control group, the cerebral oxygenation reading is NOT visible, and the infant will be     treated as usual.      Trial duration Monitoring by cerebral oximeter will be started as soon as possible and within     3 hours after birth and the intervention will last for 72 hours. Thereafter, each neonate     will be followed up at term date (approximately three months after birth) and at 24 months     after term date.      Outcome measures The primary outcome is the burden of hypo- and hyperoxia in %hours during     the first 72 hours after birth. The secondary outcomes are brain activity on an     amplitude-integrated electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding     protein (BFABP), neuroketal, and S100β), serious adverse reactions (SARs), severe brain     injury, and all cause mortality at term date (approximately three months after birth). The     exploratory outcomes are burden of hypoxia, burden of hyperoxia, neonatal morbidities, brain     injury score on magnetic resonance imaging (MRI), number of therapies implemented during the     intervention, physiological variables (mean blood pressure (BP), pulse oximeter oxygen     saturation (SpO2), and partial pressure of carbon dioxide (pCO2)), and psychomotor impairment     according to neurodevelopmental scales at 24 months after term date.   "
129483|NCT01590290|"     The purpose of this study is to determine if a pay for performance model in contrast to the     traditional fee for service model may improve the number of patients discharged being     treated in accordance with Joint Commission on Health Care JCAHO (a non-for profit     organization that accredits health care organizations) standards and standard of care for     management of hyperlipidemia      In this study the investigators will evaluate these two models by training resident     physicians (doctors in training) on JCAHO core measures and specific criteria related to     accepted standard of care for acute myocardial infarction and heart failure. The physicians     will be randomized to a pay for performance or a fee for service model. Then a medical record     review will be performed on patient records that received a discharge diagnosis of myocardial     infarction or heart failure and were cared for by the physician subjects   "
129484|NCT01590277|"     Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is     looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's     effects on driving an automobile.   "
129485|NCT01590264|"     Repetitive Transcranial Magnetic Stimulation (rTMS) is a novel brain stimulation technique     that uses pulsating magnetic fields to stimulate underlying neurons in the cerebral cortex.     The investigators propose an open-label pilot study investigating the effectiveness of rTMS     in the treatment of tinnitus stimulation of the left dorsolateral prefrontal cortex (DLPFC),     an area known to be important for mood and attention, along with stimulation of the left     temporoparietal cortex (TPC). This is a feasibility pilot study.   "
129486|NCT01590251|"     This study is designed to develop an effective adjunctive treatment using yoga for chronic     pain and opioid dependence.   "
129487|NCT01590238|"     Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active     production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal     findings of improvement of hair appearance after PRFM injection in the scalp suggest that     PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly     basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density     will be assessed by comparing pre- and post-treatment photographs and non-invasive     measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.   "
129488|NCT01590225|"     This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of     boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part     A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are     non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to     (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment     failure) (Part B). Part C is long-term follow up and no study treatment will be administered     during this period, but participants who do not achieve viral clearance will be allowed to     receive other treatments for CHC.   "
129489|NCT01590212|"     The purpose of this study is to compare the effectiveness of a relationships based antenatal     intervention (Mellow Bumps) against a comparison intervention (Chillout In Pregnancy) and     also against the normal antenatal care which is received during pregnancy (Care As Usual).     The Mellow Bumps intervention will seek to improve maternal anxiety and maternal sensitivity     whilst the Chillout In Pregnancy intervention will aim to improve only maternal anxiety. This     will allow the researchers to determine what type of intervention, if any, is most successful     at improving the outcomes of the mother and child. This will be measured by looking at the     mother's stress response, anxiety, depression and irritability, the baby's stress response     and the interactions between the mother and the baby. Participants in the study will be     pregnant women who would be between 20 and 30 weeks pregnant at the start of the antenatal     intervention. Participants will be chosen to take part in one of the three conditions (Mellow     Bumps, Chillout In Pregnancy or Care As Usual) at random. All participants will be asked to     complete questionnaires and give saliva samples prior to the intervention. The questionnaires     will also be repeated at the end of the intervention and at a follow up occurring eight to     twelve weeks after birth. Consent will also be sought to take saliva samples from the baby     before and after a routine blood test when the baby is five days old. This information will     then be evaluated to establish the effectiveness of the proposed interventions.   "
129490|NCT01590199|"     This study will evaluate long-term safety and tolerability of pasireotide LAR in combination     with everolimus in advanced metastatic NET patients, who who have not progressed during 12     months of combination therapy with pasireotide LAR and everolimus.   "
129541|NCT01589523|"     The purpose of this research study is to determine the way (mechanisms) by which your defect     in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of     vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your     vitamin absorption and your liver disease. An investigational therapy is one that not     approved by the United States Food and Drug Administration (FDA) and is being provided to you     under an Investigational New Drug application from the FDA.   "
129491|NCT01590186|"     Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity     is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore,     metatarsalgia can be a sign of excessive load caused by sport activities or at work. The     condition is very common at diabetics and patients with rheumatism.      The purpose of the study is to examine the load under the front foot at health people and     patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the     best treatment of the flat foot deformity at each patient.   "
129492|NCT01590173|"     The addition of heparin and prednisolone increases pregnancy outcome parameters in women     undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.   "
129493|NCT01590160|"     Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal     pleural mesothelium, and is associated with exposure to asbestos.      Once a rare disease, it is increasing in incidence in the UK and is presently more common     than cervical cancer. MPM is characterized by local invasion of adjacent structures including     the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of     breath.      Median survival with best supportive care alone is approximately 6-9 months and most cases of     mesothelioma present in the advanced setting. Therefore this trial will be looking at whether     a new drug, Ganetespib has any improvement on survival for these types of patients.   "
129494|NCT01590147|"     This randomized clinical trial studies the preliminary efficacy of a yoga skills training     (YST) compared to counseling and education (CE) for reducing treatment-related symptoms in     patients with colorectal cancer who are receiving chemotherapy. The YST may reduce fatigue,     other treatment-related symptoms, and improve the quality of life (QOL) of patients with     colorectal cancer. It is not yet known whether YST is more effective then CE in reducing     these outcomes.   "
129495|NCT01590134|"     Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat     anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators     think that there could be ways to reduce the number of iron tablets needed, by increasing the     dietary intake of iron. In this study the investigators will assess the efficacy and safety     of a dietary iron supplement compared to iron tablets using controls and new biomarkers.   "
129496|NCT01590121|"     Hereditary Haemorrhagic Telangiectasia (HHT) is a condition in which sufferers have abnormal     blood vessels which makes them more likely to bleed than other people, particularly in the     lungs, which results in low blood oxygen levels. Flying may make this worse and cause     problems. The investigators want to know if there are an increased number of problems on     flights compared to on land.      The investigators currently do not have any evidence based guidelines on air travel to best     advice people who suffer with HHT. The investigators would therefore like to ask individuals     who have HHT about their experience on a flight, using a postal questionnaire.   "
129497|NCT01590108|"     The purpose of this study is to        -  Determine blood peptide levels and investigate any tissue gradients of apelin in          patients with idiopathic pulmonary arterial hypertension and healthy volunteers.        -  Evaluate the effect of exogenous apelin infusion on exercise performance in healthy          volunteers and patients with idiopathic pulmonary arterial hypertension.   "
129498|NCT01590095|"     Brief Summary:      The purpose of this study is to measure the independent and combined effects of interventions     that improve water quality, sanitation, hand washing, and nutrition on child growth and     development in the first years of life.   "
129499|NCT01590082|"     The goal of this clinical research study is to find the highest tolerable dose of doxycycline     that can be combined with temozolomide and ipilimumab in patients with advanced melanoma. The     safety and level of effectiveness of the study drug combination will also be studied.      Doxycycline is designed to treat bacterial infection. It also blocks a protein called iNOS     that is important in tumor cell growth, which may slow the growth of or kill cancer cells.      Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of     cells). This may stop the cancer cells from dividing into new cells.      Ipilimumab is designed to block the activity of cells that decrease the immune system's     ability to fight cancer.   "
129500|NCT01590069|"     The goal of this clinical research study is find the highest tolerable dose of interleukin-2     (IL-2) that can be given as an inhaled mist to patients with lung metastases. The safety of     this drug using this administration will also be studied.      IL-2 is a protein that triggers white blood cells, called natural killer cells or T-cells, to     kill cancer cells. When given as a shot or by vein, IL-2 has been known to cause fevers and     flu-like side effects, including rashes, fatigue, and extra fluid in the skin or lungs. These     symptoms are less when IL-2 is inhaled as a mist into your body.   "
129501|NCT01590056|"     About 300 patients with Parkinson's disease (PD) have been successfully treated by deep brain     stimulation (DBS) during the last 10 years in Hadassah. In most of the patients the site of     stimulation is the subthalamic nucleus (STN). Recent studies by our group and others have     demonstrated that the STN is divided into motor and non-motor areas. The investigators have     recently shown that electrophysiological mapping of the STN during the surgery can     differentiate motor and non-motor areas of the STN. Existing methods of adjustment of DBS     parameters aim at amelioration of the motor signs and therefore with inactivation of the STN     motor territory only. Although the DBS parameter setting is believed to influence the mental     and cognitive states, there is no data that correlates stimulation parameters with mental and     cognitive state. In addition, DBS parameter setting is also believed to influence important     verbal functions which are partially related to motor, mental and cognitive states, but no     data correlates the verbal function with the DBS stimulation parameters.      The investigators hypothesize that the cognitive areas of the STN have distinct     electrophysiological properties similar to our findings with the limbic / mental areas of the     STN. The investigators further hypothesize that specific stimulation of these cognitive areas     can influence the cognitive state and thus treatment with cognitive-adjusted DBS can improve     the cognitive symptoms of PD.      In this project, the investigators intend to map the motor, emotional and cognitive areas of     the STN using neuronal (single units) responses to emotional voices and cognitive tasks and     to identify the emotional and cognitive spectral signature of the STN single unit activity     using spectral analysis and neuronal responses to emotional voices and cognitive tasks. In     addition the investigators intend to find the neuronal signature of speech and to find the     correlation between motor, mental and limbic electrophysiology to speech. The investigators     also intend to investigate the motor, emotional and cognitive processing of PD patients by     manipulating the stimulation of the STN. The proposed study will combine neural recording,     stimulation and psychological and cognitive tests to shed new light on processing in the     basal ganglia, as well as to provide better treatment for PD patients.   "
129519|NCT01589809|"     The purpose of the interventional study is to determine whether Nicotinamide is effective at     upregulating the Frataxin (FXN) gene in patients with Friedreich's ataxia (FRDA) where this     gene is abnormally 'switched off'.      The purpose of the non-interventional study is to investigate the use of novel,     highly-sensitive technology to capture clinical deficit and measure subtle changes in the     activities of daily living and to correlate functional changes to levels of expression of     Frataxin protein and the epigenetic structure of the Frataxin gene over a 9-12 month period     without nicotinamide. Healthy volunteers will be included as comparators in this part of the     study.   "
129511|NCT01589926|"     Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed     by having findings on a chest x-ray and one of the following: chest pain, fever, or trouble     breathing. Patients with Acute Chest Syndrome can get very sick and require an exchange     transfusion (special large blood transfusion) and mechanical ventilation. Bi-level Positive     Airway Pressure (BLPAP) is a device that blows air into a patients lungs via a mask that     covers the nose. Our goal is to determine whether giving children BLPAP when they have ACS,     in addition to providing standard clinical care for ACS alters the clinical course of these     patients. The investigators hypothesize that patients receiving effective BLPAP will have     milder clinical courses resulting in shorter hospital stays and fewer transfers to the     intensive care unit and exchange transfusions.   "
129591|NCT01588873|"     The main aims of this study are:        -  to investigate and compare the effects of long lasting use (59 weeks) of vaginal and          oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid          profile, and serum levels of SHBG and hs-CRP in women with PCOS.        -  to compare the metabolic effects of oral and vaginal combined contraceptives and to find          out whether oral or transvaginal contraceptive can be recommended to a particular group          of women, for example in women with increased metabolic risks.        -  to clarify whether the unfavourable effects of combined contraceptives diminish with          time (after use of one year).   "
129502|NCT01590043|"     Under normal conditions intestinal mucosa presents a baseline physiological inflammation     caused by a controlled immune response that eliminates offending dietary and microbial     antigens. This inflammation disappears once the cause is eradicated. In case of inappropriate     immunological response, the inflammation becomes chronic and harmful, resulting in anatomical     and functional abnormalities, namely inflammatory bowel disease (IBD).      Although it is critical for the IBD patients to undergo early diagnosis and management before     the development of severe complications, but as IBD has vague and non-pathognomonic clinical     features, the clinician is usually mislead into late suspicion and detection of IBD.      Diagnosis traditionally depended on a combination of pathologic evaluation together with the     histological, clinical, radiological, endoscopic, surgical, laboratory (serological)     features. Recently, serological markers were identified and became of special interest as     they do not only detect the occurrence of IBD but also the potential of its development and     may be used as prognostic tools. More recently, stool markers were detected and used for     diagnosis.      Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic tool.     Saliva can present an alternative form of body fluids that simplify diagnostic procedures.      Our hypothesis is that IBD patients have special salivary biomarkers that may be identified     through salivary analysis, where later on a simple non-invasive test can be applied in the     form of an easy-to-use kit, being available at the clinician's clinic for the establishment     of an immediate and early diagnosis of the destructive inflammatory bowel disease.   "
129503|NCT01590030|"     The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and     fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.   "
129504|NCT01590017|"     RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing.     Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together with     radiation therapy may be an effective treatment for cervical cancer.      PURPOSE: This trial studies how well cisplatin and radiation therapy work in treating     participants with HIV-associated locally advanced cervical cancer.   "
129505|NCT01590004|"     This study aims to develop a technical description of lumbar medial branch ablation using the     LumbarCool system. The procedure uses cooled radiofrequency (cooled-RF) technology in     treating patients with diagnosed lumbar facet joint pain.   "
129506|NCT01589991|"     Fluoride toothpaste has been associated not only with declining dental caries prevalence but     also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride     toothpaste use, the purpose of this study is to evaluate the availability of fluoride     concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries     effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from     ingested toothpastes (with potential to cause dental fluorosis), in a sample of young     Brazilian children using toothpaste formulations representative of those available and most     used by this age-group.   "
129507|NCT01589978|"     This study is designed to observe clinical outcomes in patients receiving the PROMUS Element     Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.     Patients will have symptomatic heart disease or documented silent ischemia. This is a     prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years.     Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.   "
129508|NCT01589965|"     The HIV/AIDS epidemic is a major concern in many countries. The epidemic is especially acute     in Lesotho where roughly one quarter of the population is infected by HIV/AIDS. In Lesotho,     and elsewhere, new innovative approaches to induce safer sexual behavior have been     desperately called for, particularly in view of the limited impact that existing prevention     schemes have had on the trajectory of the HIV/AIDS epidemic.      One of the key questions is to understand why individuals get involved in short-term risky     sexual behavior when the potential long-term cost of becoming HIV infected is so high? A     follow-up question is what replicable and feasible interventions can affect this trade-off     between short and long run returns? The primary aim of this study is to evaluate whether the     use of short-term financial incentives can affect this trade-off, thereby influencing young     individuals' decisions with respect to sexual and reproductive health behavior, and thus in     the end reduce HIV incidence rates. The investigators will study this question using a sample     of population attending served by New Start Voluntary Counseling and Testing (VCT) sites that     a local NGO, Population Service International (PSI), has already implemented in Lesotho.      The investigators propose to conduct a randomized controlled trial to test whether adding a     financial incentive to remain STI-negative in the form of a lottery can promote safer sexual     activity. The lotteries will work as follows: if the individual is tested negative on a set     of curable STIs, she will get a lottery ticket with the chance to win a big prize. If she     is tested positive, she will receive free treatment, but no lottery ticket. If an individual     who tested positive is cured, she can come back in the lottery system and get a later chance     to win the lottery ticket if she remains STI-negative. The outcome will be to measure the     impact of financial incentives on HIV incidence after two years.      The results of this research project will be disseminated through academic and non-academic     conferences, workshops, publications in academic journals, and also in policy journals with     the aim to reach out to policy makers outside the research community.   "
129509|NCT01589952|"     According to published literature, treatment with pegylated interferon (Peg-IFN) is     associated with end of treatment response in treatment naive patients with chronic hepatitis     B (CHB). It has antiviral as well as anti-fibrotic properties and treatment with Peg-IFN     results in improvement of liver histology and down regulation of progression to cirrhosis of     liver. Peg-IFN is administered for a finite duration. The major limitation of Peg-IFN is that     only 30-49% patients are benefited by this anti-viral drug. Another potent anti-viral drug,     entecavir (ETV), on the other hand, reduces HBV replication in most patients, but causes     improvement of liver histology in only 30%, possibly because of its lack of immune modulatory     ability like Peg-IFN. Also, ETV treatment is associated with several complications like     emergence of HBV mutant. The aim of this study is to assess whether the combination of these     two 'unique' anti-viral drugs offer the best possible outcome to treatment-naïve CHB     patients, in terms of treatment response (virological and biochemical), treatment cost and     duration and adverse events.   "
129510|NCT01589939|"     This prospective study evaluates the clinical utility of a novel real-time localization     system allowing for smaller volumes of normal tissue to be included in radiation field and     determines dosimetric parameters and adverse effect profiles of radiation therapy using this     technology. Subjects will have beacon transponders implanted into the prostate to more     precisely localize the position of the organ during radiation therapy. Hypothesis: 1.     Treatment with highly targeted radiation therapy can be delivered in a daily treatment time     consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced     PTV margin will result in a significant decrease in rectal and bladder volume treated.   "
129512|NCT01589913|"     Aim and Background: Although implantable cardioverter defibrillators (ICD) save lives, many     ICD-patients experience psychosocial complications such as anxiety disorders, depression and     reduced quality of life after ICD-implantation. A recent review has indicated great potential     for psychosocial interventions to reduce anxiety and to increase exercise capacity of     ICD-patients. In a previous study, the investigators showed that mailed information about     technical, medical and psychological effects of ICD plus phone counseling are effective     interventions for reducing anxiety, psychological distress and increasing QoL in ICD-patients     < 65 years. In a pilot study the investigators also documented promising effects of an     internet based intervention with similar content.      Method: In a prospective, multicenter, multidisciplinary, half-open, part-randomized,     controlled clinical trial N = 200 patients with an ICD will either receive medical care as     usual or additionally attend a psychosocial prevention program via remote care. Psychosocial     support will be provided utilizing the advantages of the internet. Thus, patient-centered     support will be offered independent from time and location.      Outcome measures are psychometric data (questionnaires on cardiac fear, etc.), cardiac     functioning, and clinical status which will be assessed up to 1 week before ICD-implantation     (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12     months after T0 (T3). Furthermore, demographic data, personality characteristics,     expectations, physiology, pro-inflammatory cytokines and cardiac status will be assessed as     mediating or moderating variables.      Hypotheses: A web-based psychosocial intervention in addition to medical care as usual leads     to increased QoL and reduced anxiety and depression. Secondary goals are the identification     of psychosocial and medical predictors, mediators, and moderators of treatment efficacy.     Moreover, differences between patients with ICDs implanted for primary vs. secondary     prevention will be explored.      Conclusion: This project will evaluate the feasibility and efficacy of an internet based     intervention for ICD-patients. Furthermore, the investigators aim at identifying predictors     and mediators of treatment outcome. This will improve interdisciplinary care for     ICD-patients; further applications for other cardiovascular disorders as well as preventive     programs for heart failure seem possible.   "
129513|NCT01589900|"     Sox2 has been studied in several types of human solid tumors. The investigators found that     Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal     tissues. So the investigators assumed that whether Sox2 plays an important role in the     progression and migration of colon cancer.   "
129514|NCT01589874|"     Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal iron     utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC) survival     is a very common problem in hospitalized patients for acute inflammatory diseases and     develops within few days from the onset of illness. Deleterious effects of anemia include     increased risk of cardiac related morbidity and mortality in critically ill and older     patients.      Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron     trafficking.      Several studies have been performed on pathophysiology of AI in patients affected by chronic     diseases but few explore iron metabolism in humans with acute inflammation.      The aim is to develop effective new strategies to detect and manage AI in the setting of     acutely ill patients, based on the understanding of iron balance underlying this disorder.   "
129515|NCT01589861|"     This study is based upon the following points:        1. Resistance to trastuzumab, either primary or secondary, is a clinically relevant issue.        2. PI3K/AKT activation, due to loss of expression/function of PTEN and/or activating          mutations of PIK3CA, is a mechanism of resistance with clinical relevance in breast          cancer. Such activation can be detected by:             -  IHC evaluation of PTEN protein expression             -  genotyping of PIK3CA exon 9 and 20             -  IHC evaluation of phospho-AKT expression        3. BKM120 is an effective PI3K inhibitor. BKM120 and anti-HER2 therapy may have a          synergistic antitumor activity in preclinical model of HER2+ breast cancer.        4. Lapatinib is an effective anti-HER2 therapy in trastuzumab-resistant disease.        5. For the evaluation of novel targeted therapies, selecting a patient population enriched          for activation of the target to be modulated should allow to maximize the differences in          clinical outcome that are expected in the experimental arm, and thus to minimize the          patient number to include.        6. We propose to test in a phase I/II study the combination of lapatinib and BKM120 in          trastuzumab-resistant HER2+ MBC patients, enriched for activation of PI3K/AKT as          detected by loss of expression of PTEN (IHC), and/or mutation of PIK3CA and/or          overexpression of phospho-AKT (IHC). Only for phase II patients, mutational status will          be an inclusion criteria. For phase I patients molecular status will be a retrospective          exploratory analysis.   "
129516|NCT01589848|"     1. Hypothesis           a. There are patients with von Willebrand Disease in Cuenca.        2. Primary question           a. How many women referred with a history of bleeding may have von Willebrand disease?        3. Secondary             1. Associations between the bleeding score and initial laboratory studies             2. What are the differences on subgroups of enrolled patients with the bleeding score?        4. Ancillary             1. What is the clinical and socio-economic status of women with von Willebrand Disease               in Cuenca?             2. What is the clinical and socio-economic status of patients with Hemophilia in               Cuenca?   "
129517|NCT01589835|"     Nearly six million Canadians are living with an increased risk of diabetes (prediabetes) and     approximately 50% of these will develop type 2 diabetes within five years. The investigators     wish to help these people change their lifestyle, to prevent them from getting diabetes.     Trials have shown that by supporting people with prediabetes to be more active and have     healthier eating habits they can halve their risk. However, these interventions were very     costly and not performed in Canada. With the help of local Family Physicians and other health     professionals (e.g. physiotherapy, psychology, endocrinology, nursing) the investigators have     created a less expensive intervention suitable for the Canadian population and health system.     The investigators need to perform a study to see whether these modified approaches are     practical for Canadians and likely to be effective. People at risk will be invited to     participate from family practices that have helped us in the initial stages of this program.     Family practices will be randomized to giving either the study intervention or continue with     the physician's usual care. People receiving the intervention will have an appointment with     their family doctor to discuss their exercise and eating habits and agree changes that are     necessary. A prescription detailing these changes will be completed and signed by the family     physician and participant. Participants will be given the name of a lifestyle change     facilitator (LCF) who will receive a copy of the prescription and contact the participant to     help them set achievable goals. The LCF will contact participants once a month for six months     to help them achieve these goals. The investigators eventual aim is to test this intervention     in a large-scale randomized control trial. To achieve this it is necessary to pilot all     aspects of the trial. Information from the pilot study can then be used to design and perform     a large-scale study effectively. The investigators hope that eventually the numbers of     Canadians progressing to having diabetes will be reduced.   "
129521|NCT01589783|"     Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of     this vitamin for the proper development of the fetus, are a significant risk group. The     purpose of this study is to examine which factors - education, knowledge from     non-professional sources, recommendations from medical staff - influence the use of vitamin D     among pregnant women in light of the lack of a clear health policy, and to help formulating     guidelines for a new health policy with specific recommendations for vitamin D dosage in     pregnancy.   "
129522|NCT01589770|"     Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart     disease than people that do not have RA. we believe this is caused by the inflammation     produced by RA.   "
129523|NCT01589757|"     MAIN STUDY: Low glycaemic index (GI) diets are recommended by the Canadian Diabetes     Association for treating type 1 and 2 diabetes mellitus (DM), but the role of GI in the     management of gestational diabetes(GDM)is not yet clear. The main purpose of this study is to     determine the effect of a low GI diet on blood sugar control in women with GDM. The effect of     a low GI diet on maternal oxidative stress, pregnancy and delivery outcomes and markers of     risk for diabetes after birth in both the mother and baby will also be assessed. SUB-STUDY:     The main purpose of the sub-study is to determine if the breast milk (BM) of women with GDM     consuming a low GI diet will have a higher antioxidant capacity than the BM of women     receiving a medium-high GI diet (control/standard care). The effect of a low glycaemic index     diet on maternal dietary intake of specific nutrient-antioxidants (i.e. vitamin C, E, and     beta-carotene) (prenatal and postpartum) and concentration of vitamin C, E, and beta-carotene     in participants' transitional and mature BM will also be assessed. The ORAC (Oxygen radical     absorbance capacity) assay will be used to assess overall antioxidant capacity. The     antioxidant capacity of BM in women with GDM will also be compared with that of women without     GDM.      Hypotheses:      MAIN: The use of low-GI foods in the management of GDM reduces postprandial BG and oxidative     stress; thereby reducing maternal and infant perinatal complications.      SUB-STUDY: Breast milk (BM) of women with GDM consuming a low GI diet will have higher BM     antioxidant than women receiving the medium to high GI diet. BM of women with GDM will have     lower antioxidant capacity than that of women without GDM.   "
129524|NCT01589744|"     The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical     practice, if after giving birth, the placenta is not expelled naturally, an active management     should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus,     examination of the birth canal), begins with uterotonic treatments for invasive treatments     lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these     techniques and the desire to preserve fertility required to devise new therapeutic solutions,     which have recently led to the development of an innovative medical device intrauterine     hemostasis.      The postpartum haemorrhage are mainly the result of weak and bleeding from the surface     corresponds to the placental insertion, which is no longer localized. With the innovative     medical device, our main hypothesis is that the uterine walls will append to the walls of the     cup after depressurization of the latter. The actuation of the suction cup will lead to     aspiration of all sides of the uterus (it is mostly the anterior and posterior that are     important). The suction cup is flexible to adapt to the size of the uterus in order to be     placed and removed easily from the uterine cavity.   "
129525|NCT01589731|"     Bovine β-lactoglobulin (Bos d 5) is an allergen from cow's milk with relevance to human     health. We employed β-lactoglobulin polymerized using microbial transglutaminase as a model     of study to identify whether protein polymerization could reduce in vivo allergenicity and     maintain in vitro and ex vivo immunoreactivity for the purpose of producing a suitable     molecule for use in tolerance-induction protocols. Based on previous protocols applied in     mice and children, we performed in vivo challenges (using a skin prick test) with native and     polymerized β-lactoglobulin in adult patients with an IgE-mediated allergy to Bos d 5. In     vitro humoral immunoreactivity was analyzed using immunoblotting. Cell-mediated     immunoreactivity was analyzed using ex vivo challenges with native and polymerized     β-lactoglobulin monitored by leukocyte adherence inhibition tests. The study hypothesis is to     identify a decrease on beta-lactoglobulin immunoreactivity after polymerization.   "
129526|NCT01589718|"     The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves     vitreous hemorrhage prior to surgical intervention and to evaluate the stability of     pre-existing tractional retinal detachment.   "
129527|NCT01589705|"     There are substantial data demonstrating increased endothelial dysfunction, inflammation and     oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the     association between serum uric acid level and endothelial dysfunction has not been elucidated     yet in these patients. Therefore, in this study, the investigators aimed to examine the     relationship between the uric acid level and the ED in normotensive ADPKD patients with     preserved renal function.   "
129528|NCT01589692|"     In the United States, over 300,000 individuals over age 65 suffer from distal radius     fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of     experience treating DRFs, management of elderly DRFs is still controversial. Close reduction     and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures,     common in the elderly, often collapse and displace. The three currently applied surgical     techniques are close reduction and percutaneous pinning, external fixation with or without     percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence     indicates that locking plate fixation can permit elderly patients to move their hands and     wrists much sooner in order to return to self-care activities more quickly. Although these     outcomes are promising, there is no randomized controlled clinical trial to demonstrate that     the more invasive, and perhaps more costly, plating technique is superior to the other     simpler approaches.      The specific aim of this 18-center randomized controlled trial is to compare outcomes of     these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim     is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes     following treatment by close reduction and casting alone. This clinical trial is the most     ambitious study in hand surgery by assembling most of the leading centers in North America to     collect evidence-based data to guide future treatment of this prevalent injury in the growing     elderly population.   "
129529|NCT01589679|"     To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of     hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.   "
129590|NCT01588886|"     Chronic kidney disease is a severe medical problem in Taiwan public health issue, which the     highest incidence and prevalence rate in the world.Proton pump inhibitors may increase the     risk of pneumonia appearance, which were caused by profound irreversible gastric acid     suppression. The study purpose was to characterize difference of developing pneumonia in     chronic kidney disease of prior use proton pump inhibitors.   "
129780|NCT01586390|"     In this study we compare two treatment options for ankle sprains. 100 patients were     randomised between a flexible cast treatment and a removable and adjustable brace made out of     the same materials.      Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures     were patient satisfaction scores with treatment as well as treatment result.   "
129543|NCT01589497|"     Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are     very small living agents that are spread by coughing and can be killed by taking TB drugs. To     kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and     then two drugs for a further 4 months. During the first 2 months patients take rifampicin,     isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and     rifampicin for a further 4 months, making a total of 6 months therapy.      In A5307 the investigators wanted to test a new combination of drugs to see if the     investigators could treat TB faster in the future.      Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few     days and may not be needed after the first two doses of TB treatment to kill the TB bacteria.     After that its effects wear off to the point that it may even interfere with the other drugs.     The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a     different drug, instead could treat TB faster. This study was the first time that this type     of regimen without isoniazid had been tested in humans. If the investigators could show that     isoniazid stops working after a few days, the investigators could then try to see if they     could possibly make a better tuberculosis treatment in the future.   "
129544|NCT01589484|"     Kidney stone disease affects almost 10% of overall population, often requiring a surgical     intervention. Currently, shock wave lithotripsy is considered a first-line treatment option     for patients suffering from symptomatic kidney stones smaller than 2.0 cm, providing     reasonable stone-free rate. Actually, the outcomes from SWL vary largely due to several     factors including stone burden, stone density, stone-skin distance (SSD), and patient's body     habitus. Furthermore, the imaging exam modality (i.e. ultrasound versus computed tomography     scan) performed to assess the presence of residual fragments also impacts on SWL outcome     analysis.      We aim to perform a well-controlled prospective evaluation of all variables that may impact     on fragmentation and clearance of lower pole calculi after SWL. These variables are assessed     exclusively by a noncontrast computed tomography scan (NCCT), eliminating the necessity of an     intravenous urography to study renal collecting system anatomy; an imaging exam that is not     routinely performed anymore for kidney stone patients.   "
129545|NCT01589471|"     Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer.     Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious     impacts on quality of life in a third of the cases.      One possible physiopathology hypothesis suggests an ongoing spastic process; different     mechanisms have been postulated. These include alteration of normal anorectal sensation with     loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced     rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy     or during surgery.      Current available treatments are often ineffective, highlighting the need for more successful     management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the     neuromuscular junction. It is currently used for the treatment of various smooth muscle     spastic diseases.      The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical     treatment alternative for LARS. The goal of this study is to document the effects of     intra-rectal BTX-A injections on sphincter function and quality of life of patients with     LARS.   "
129546|NCT01589458|"     Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based     toothpastes, the present study aim to evaluate F availability in saliva after use of the     top-selling Brazilian toothpastes. In a blind, crossover clinical trial study, volunteers     will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste     (negative control group); 2) NaF/silica based toothpaste 3)MFP/calcium carbonate based     toothpaste. After brushing, a rinse with purified water will be performed. Unstimulated     saliva will be collected before and up to 60 min after brushing. Ionic fluoride and total     soluble fluoride (corresponding to the sum of fluoride as ion and as MFP) will be determined     after acid treatment of salivary samples to hydrolyze MFP. Fluoride will be determined using     an ion selective electrode.   "
129547|NCT01589445|"     -  The present study was undertaken to assess the efficacy and safety of two different          insulin sensitizers (namely Pioglitazone and Metformin) among subjects with type 2          diabetes mellitus (T2DM) in Bangladesh.        -  A prospective, double-blind, single group, 'within-subject' designed clinical trial of          77 diagnosed T2DM patients out of 130 patients with glycosylated haemoglobin (HbA1c)          ≥7.2±1.5%, aged 46±6.4 years and registered for diabetes treatment in Bangladesh          Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders          (BIRDEM) was carried out.        -  The study was conducted between November 2008 and September 2010.        -  Baseline data, included case history of the patients,anthropometric measurement,          biomedical parameters psychosocial factors, were collected from each subject and then          enrolled to receive treatment with 001 drug once daily for three months, then the          patients were left for wash out with metformin 850mg once daily for one month; then they          received 002 drug once daily for further three months.        -  Dietary chart was remained as before.        -  DNA was isolated by Chelex method using the primers and control DNA,restriction          Digestion Enzyme Endonuclease Hae 111 for genotyping PPARγ-(Peroxisome Proliferator          Activated Receptor gamma)Pro12Pro             -  (Proline12Proline)/Pro12Ala-(Proline12 Alanine))/Ala12Ala-(Alanine12Alanine).        -  The blinded drugs were decoded after analyzing results, 001 tablet was pioglitazone (30          mg once daily) and 002 tablets was metformin (850mg once daily). Bio-medical outcomes          were measured to assess the efficacy of both the drugs each month. After finishing the          treatment period the effects of two drugs were compared using SPSS.And the association          between the pioglitazone drug effects and genetic polymorphism was also assessed.        -  The metformin effects was assessed also using the response rate of HbA1c <7.0% after 3          months treatment to the patients.   "
129548|NCT01589432|"     People with diabetes can, over time develop nerve damage throughout the body with symptoms     such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.   "
129549|NCT01589419|"     An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the     PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with     locally advanced rectal cancer (LARC).   "
129550|NCT01589406|"     Patients with premalignant (CIN3) and malignant cervical cancer will asked to complete     questionnaires regarding intimacy (ENRICH) and life adaptation (PAIS) before treatment     (surgery or radiotherapy) and after completion of treatment in order to estimate the     influence of disease and treatment on quality of life indices.   "
129576|NCT01589068|"     The proposed clinical studies will analyze the interactions between progesterone, nicotine,     fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and     cardiovascular measures. It is hypothesized that the administration of progesterone at a dose     that mimics luteal phase levels in normal cycling women will diminish the positive subjective     effects of nicotine, as has been consistently observed for cocaine. This novel approach could     have direct implications for facilitating smoking cessation treatment in women of     reproductive age   "
129551|NCT01589393|"     Victims of trauma with severe head injury who have bled into their brains are at high risk of     developing blood clots in their legs. These blood clots can break off and travel through the     bloodstream to the lungs causing death. Blood thinners can be given to patients to prevent     blood clots from developing but this can leave patients at risk for additional bleeding in     the brain causing further damage or death. The earlier blood thinners are started the more     effective they are at preventing blood clots but some patients with severe head injury who     have bled into their brains will develop further bleeding even if they do not receive blood     thinners. Even though a growing body of research has shown that the majority of bleeding in     the brain stops within the first 24 hours after injury and that it is safe to start blood     thinners as early as 24 hours after injury, doctors are still waiting longer than 4 days to     start blood thinners in these patients over concerns of worsening bleeding. In Canada, almost     half of the patients with severe head injury do not receive blood thinners until at least     five days after injury. Delays in starting blood thinners appear to put patients at increased     risk of developing blood clots, unnecessarily. This study will compare the benefits of     starting low-molecular weight heparin (LMWH), a type of blood thinner, early (less than 48     hours) versus the current practice (waiting until the 5th day after being injured) in     preventing blood clots in patients who have bled into their brains after severe head injury.     The investigators believe that starting LMWH earlier will be more effective in preventing     blood clots without worsening any bleeding when compared to waiting to start blood thinners.     This study is called OPTTTICH (Optimal Timing of Thromboprophylaxis in Traumatic IntraCranial     Haemorrhage) and will be the largest Canadian investigator-initiated randomized control trial     on blood clot prevention in trauma patients with severe head injury who have bled into their     brains.   "
129552|NCT01589380|"     We hypothesized that fimasartan, a new generation ARBs, would improve exercise capacity and     decrease the rate of progression of AS by modifying hemodynamic factors and reducing adverse     LV remodeling favorably in patients with asymptomatic moderate to severe AS.   "
129553|NCT01589367|"     Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor     positive breast cancer patients      Phase II multicenter 1:1 randomized clinical trial Total 208 patients      Primary endpoint Clinical response rate      Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent     mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy     Toxicity profile of neoadjuvant letrozole, metformin   "
129554|NCT01589354|"     This study evaluates two anaesthetic techniques namely interscalene brachial plexus block and     intra-articular local anaesthetic injection. Both techniques are currently used for providing     postoperative pain relief following arthroscopic shoulder stabilisation operation. It will be     a randomised controlled trial involving 30 patients in two groups.   "
129555|NCT01589341|"     This research studies chromosomes in samples from younger patients with neuroblastoma.     Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors     learn more about changes that occur in DNA and identify biomarkers related to cancer.   "
129556|NCT01589328|"     Effect of Early management on PAin and DEpression in patients with PancreatoBiliary Cancer,     EPADE-PB      Purpose      To determine whether early palliative care integrated with usual oncologic care with     automated symptom monitoring can improve depression and pain in patients with cancer   "
129557|NCT01589315|"     This pilot, open label investigation evaluates the safety and efficacy of a new form of     electroconvulsive therapy (ECT). Both the efficacy and adverse cognitive effects of ECT are     highly contingent on the intracerebral current paths and current density of the ECT stimulus.     However, the impedance of the skull and individual differences in skull anatomy severely     limit the spatial targeting of stimulation, and create marked individual differences in     intracerebral current density. To address these problems, the investigators are exploring     various means of overcoming this limitation.      An approach is to modify the electrical stimulus to induce focal seizures. The most common     methods of ECT administration in the US use a bidirectional, constant current, brief pulse,     with large (approximately 3 sq. in. surface area) and identically sized and shaped     electrodes. In contrast, in this protocol the investigators have coupled unidirectional     current flow with an electrode geometry involving a small and large electrode that differ by     more than 3:1 in surface area.      Unidirectional currents were widely used in ECT during the, 1940's and continue to be used in     European and American devices today. Transcranial electrical stimulation can be made focal by     stimulating with an anode-cathode arrangement, with the electrodes differing in surface area.     The investigators have shown in nonhuman primates the capacity to produce focal frontal     seizure induction under conditions when a unidirectional current flows from a small anterior     anode (placed on the forehead over the nasion) to a large posterior cathode just anterior to     the motor strip. Furthermore, the investigators expect that some, if not all, of these     seizures do not result in motor convulsions.      Thirty outpatients referred for ECT will participate. Relative to concurrent reference data     from our ongoing ECT protocols, the investigators hypothesize that acute and subacute adverse     cognitive effects of FEAST will be substantially less than those in patients receiving     state-of-the art ECT, but with a traditional bidirectional, nonfocal stimulus. The     investigators also hypothesize that the majority of patients will remit with FEAST. Thus, by     improving the efficiency of the ECT stimulus with the switch to unidirectional current and     the use of a new electrode geometry, the investigators expect to be able to induce focal     seizures. The investigators hypothesize that this pilot study will provide evidence that this     treatment is superior to traditional ECT in having lower dosing requirements and a superior     side effect profile.   "
129558|NCT01589302|"     This is a Phase II, single institution open-label, non-randomized monotherapy study to     evaluate the clinical efficacy and durable disease control of PCI-32765 administered to     patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having     deletion 17p13 independently evaluated.   "
129559|NCT01589289|"     The impact of neurological disorders is enormous worldwide, and it is increased in poor     settings, due to lack of diagnosis and treatment facilities as well as delayed management. In     sub-Saharan Africa, the few observational studies conducted for the past 20 years show that     neurological disorders accounted for 7 to 24% of all admissions. Central nervous system (CNS)     infections were suspected in one third of all patients admitted with neurological symptoms,     with a specific microbial aetiology identified in half of these. Most CNS infections may be     considered as severe and treatable diseases, e.g. human African trypanosomiasis (HAT),     cerebral malaria, bacterial meningitis, CNS tuberculosis etc. If left untreated, death or     serious sequels occur (mortality rates were as high as 30% in the above mentioned studies),     but the outcome may be favourable with timely and appropriate management.      In poor settings, such conditions should be targeted in priority in the clinical     decision-making process. Unfortunately, most neuro-infections present with non-specific     symptoms in their early stages, leading to important diagnostic delays. Moreover, they     require advanced diagnostic technology, which is not available in most tropical rural     settings: here, you have to rely on clinical judgment and first-line laboratory results,     whose confirming or excluding powers are limited or unknown. Several rapid diagnostic tests     (RDTs) have been recently developed for conditions like malaria or HIV, but their diagnostic     contribution has not been evaluated within a multi-disease approach.      Thus, this research aims at improving the early diagnosis of severe and treatable neglected     and non-neglected infectious diseases which present with neurological symptoms in the     province of Bandundu, Democratic Republic of Congo (DRC), by combining classic clinical     predictors with a panel of simple point-of-care rapid diagnostic tests.      The evaluation of existing algorithms and elaboration/validation of new guidelines will be     described in a subsequent protocol.   "
129560|NCT01589276|"     The aim of present study was to evaluate the clinical course after emergency ventral hernia     repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk     factors for emergency repair.   "
129577|NCT01589055|"     Clinical studies are proposed to analyze the interactions between nicotine, alterations in     endocrine hormones, mood and cardiovascular measures. The studies are designed to examine the     contribution of gender and menstrual cycle phase. It is hypothesized that analysis of     nicotine's rapid hormonal, cardiovascular and subjective effects will be important for     developing novel biologic approaches to treatment for nicotine abuse and dependence as well     as advancing understanding of the neurobiology of nicotine reinforcement.   "
141868|NCT01427530|"     This study will be recording and evaluating brain activity from Deep Brain Stimulating (DBS)     electrodes in patients with Parkinson's disease.   "
129561|NCT01589263|"     Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that     affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms     (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life     significantly, and are costly.      his Phase 2 clinical research trial is a double-blind, randomized, placebo-controlled,     parallel-group study to compare the treatment effects of onaBoNT-A 200 U versus 0.4 mg per     day of oral tamsulosin in male Veterans diagnosed with moderate to severe LUTS [American     Urologic Association Symptom Score (AUASS) equal to or greater than 8] associated with BPH. A     total of 74 volunteers will be recruited to participate in this clinical trial. Volunteers     will include only males who are greater than 50 years of age and diagnosed with LUTS     associated with BPH. They are Veterans who visit the Michael E. DeBakey Veterans Affairs     Medical Center - Houston (MEDVAMC). There are no eligibility restrictions as to race or     ethnicity.   "
129562|NCT01589250|"     Use of risk scoring systems in the assessment of patients presenting with upper     gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the     system of choice, but the majority of these are characterized by retrospective designs, small     sample sizes, low rate of severe bleeding, or low mortality. The main aim of this study was     to identify the optimal scoring system.   "
129563|NCT01589237|"     This study was to determine long-term safety and tolerability, and continued efficacy in     lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS)     (HLP type I).   "
129564|NCT01589224|"     Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality     for the coronary artery disease. Recently, novel adipokines and hepatokines as well as     various inflammatory markers have been known as direct regulators of atherosclerosis.     Therefore, the investigators examine the correlation of various metabolic risk factors     including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT     in apparently healthy people.   "
129565|NCT01589211|"     To investigate the effectiveness of a smoking cessation intervention of two sessions (120 min     at a time) in a group setting on the basis of Motivational Interviewing (MI) and important     elements of Cognitive Behavioural Therapy (CBT). According to national and international     guidelines patients are advised to quit and pharmacologically supported with one of the     established first line smoking cessation treatments.   "
129566|NCT01589198|"     The purpose of this study is to learn more about asthma in people who are not well-controlled     with current asthma medication (refractory asthma). The investigators will compare data from     refractory asthmatic patients here at National Jewish Health to mild asthmatics subjects and     to people without asthma. Study experiments involve looking at samples from all 3 groups and     comparing them at a molecular level. These laboratory experiments may help identify subtypes     of refractory asthmatics that require different treatments.   "
129567|NCT01589185|"     The objectives of this study are to assess the safety, tolerability, pharmacokinetics,     pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by     Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in     addition of standard of care antibiotic treatment.   "
129568|NCT01589172|"     The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the     Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after     24 hours of care. The investigators hypothesize that TEG will identify abnormalities of     coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time     (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).   "
129569|NCT01589159|"     This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and     safety study. Eligible patients are enrolled in a single group. The investigators propose to     determine the efficacy and safety of low-dose metronomic chemotherapy with     Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with     Anthracyclines and/or Taxanes.   "
129570|NCT01589146|"     Overall, only limited evidence exists regarding the clinical benefit of antithrombotic     prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of     venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ     concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported     incidence of VTE.      The aim of this multicenter, randomized study is to assess the clinical benefit of extended     (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for     colorectal cancer.   "
129571|NCT01589133|"     The purpose of this study is to assess the consistency of the results of irregular antibody     screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent),     and the consistency of the results of irregular antibody screening with investigational     reagent on serum and plasma from same patients.   "
129572|NCT01589120|"     The purpose of this study is to compare the decision making of subjects with advanced CHF     having a verbal discussion about goals of care compared to subjects using a video.   "
129573|NCT01589107|"     To demonstrate that clinical surrogates of SICU patients who view a video decision aid in     addition to receiving written and verbal information about procedures and life sustaining     therapy in the SICU make more informed decisions than patients and clinical surrogates who     receive written and verbal information alone.   "
129574|NCT01589094|"     The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin)     given on a dose-dense treatment schedule (with less time between treatments) can help shrink     the tumor better than standard chemotherapy given on a standard treatment schedule before the     patient undergoes surgery for bladder cancer.   "
129575|NCT01589081|"     The proposed clinical studies will analyze the interactions between progesterone, nicotine,     alterations in endocrine hormones, mood and cardiovascular measures. It is hypothesized that     the administration of progesterone at a dose that mimics luteal phase levels in normal     cycling women will diminish the positive subjective effects of nicotine, as has been     consistently observed for cocaine. This novel approach could have direct implications for     facilitating smoking cessation treatment in women of reproductive age   "
129578|NCT01589042|"     To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the     effectiveness of the device for use during percutaneous transluminal angioplasty (PTA)     procedures.   "
129579|NCT01589029|"     The pilot study evaluates the efficacy and safety of Canakinumab (ILARIS®) in subjects with     proliferative diabetic retinopathy secondary to type 1 and 2 diabetes. Ten subjects will be     enrolled to receive 150 mg Canakinumab (ILARIS®) by subcutaneous injection. Beginning on day     0, each subject will receive a subcutaneous injection of study drug every 8 weeks for 16     weeks, a total of 3 injections. All subjects will undergo regular follow-up assessments every     8 weeks through 24 weeks. Fluorescein angiography (FA) is repeated every 8 weeks. In case of     progression of retinal neovascularization on FA panretinal laser photocoagulation is     administered as rescue therapy. The primary outcome is the regression of retinal     neovascularizations (NVE and NVD) in FA at 24 weeks. In addition to key secondary outcomes     including regression of diabetic macular edema, change in best-corrected visual acuity,     change in HbA1c levels and change in markers of systemic inflammation. Safety will be     assessed by measurements of vital signs, clinical laboratory assessments, and the recording     of adverse clinical events.   "
129580|NCT01589016|"     The purpose of this study is to determine the predictive value of a single serum     determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in     Vitro Fertilization (IVF) cycles, in both native and donated oocytes.   "
129581|NCT01589003|"     The current study proposes to investigate the impact of a low glycaemic index (GI), fortified     toddlers milkpowder on mood, behaviour and cognitive function in young children.   "
129582|NCT01588990|"     This open-label, prospective, single-arm, multicenter study will evaluate the relationship of     the markers of inflammation and progression-free survival (PFS) in participants with     previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A     treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or     modified infusional 5-fluorouracil (5-FU), Leucovorin (LV) and oxaliplatin (mFOLFOX6) plus     bevacizmab administered until first disease progression. Participants will then continue with     Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second     disease progression. The anticipated time on study treatment is 4 years.   "
129583|NCT01588977|"     The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The     creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study     demonstrated tibial subchondral microfractures in the group antegrade tibial tunnel unlike     group retrograde tibial tunnel. To our knowledge, no clinical evaluation was performed. The     investigators hypothesize that retrograde drilling will cause less local bone injury than     antegrade drilling in creation of the tibial tunnel for ACL reconstruction.   "
129584|NCT01588964|"     In patient with a platinum sensitive ovarian cancer recurrence is demonstrated that the     re-challenge with a compound of platinum-based, or a treatment with carboplatin in     combination with paclitaxel , determines a rate of clinical response similar to the primary     treatment, which is all the more important as the longer the time to progression from the     primary therapy.In the clinical setting there are many studies that have shown activity of     oxaliplatin and docetaxel in patients with advanced ovarian cancer. Two recent studies have     shown clinical efficacy of the combination carboplatin / docetaxel in the first line     oxaliplatin / paclitaxel to recurrence of disease, confirming the data already obtained from     studies of activity in a single agent.In surgery it has been demonstrated in a meta-analysis     including approximately 7000 patients in advanced stages of disease, that the extent of     cytoreduction is the most powerful determinant of survival.The role of secondary surgical     cytoreduction in case of recurrent disease has yet to be determined because of the lack of     prospective randomized clinical studies that may highlight the superiority of such aggressive     treatment.The combination of aggressive cytoreductive surgery and hyperthermic     intraperitoneal intraoperative chemotherapy (CHIP) used in recent clinical studies showed a     prolonged time to progression and disease-free survival in patients with ovarian cancer.     However, these studies were conducted on groups of patients with very different among     themselves and with other drugs, it is difficult to draw definitive conclusions.Given the     activities of oxaliplatin and docetaxel and their non-cross-resistance we designed a Phase 2     clinical trial on treatment of patients with recurrent ovarian cancer, platinum-sensitive,     treated with surgical cytoreduction with hyperthermic oxaliplatin-based intraoperative     intraperitoneal chemotherapy and following consolidation treatment with oxaliplatin and     docetaxel systemically every 21 days.   "
129585|NCT01588951|"     The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of     patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to     the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission     (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell     transplantation (SCT).   "
129586|NCT01588938|"     This prospective study at MAMC evaluates the utility of a rigid pelvic external     immobilization compared to limited immobilization using a novel real-time localization system     of the prostate. The sample population will include patients referred to the radiation     oncology services of both facilities for definitive treatment of prostate cancer. The study     will enroll 20 subjects from MAMC and evaluate data on 860 radiation therapy fractions.      Subjects will have Beacon® Transponders implanted into the prostate to more precisely     localize the position of the organ during radiation therapy. They will be randomized to rigid     pelvic immobilization using a Vac-Lok® system or limited immobilization with a band around     the patient's feet. They will then undergo radiation therapy planning with standard planning     target margins. The Calypso® 4D Localization System will monitor, in real time, the position     of the prostate target and adjust radiation treatments as required to ensure accurate     treatment of the prostate gland. The time of, the number, and extent of adjustments will be     recorded for analysis.      Hypothesis: 1. When treating only the prostate, treatment with rigid pelvic immobilization is     not necessary when using real-time, state-of-the-art motion tracking of the prostate.   "
129587|NCT01588925|"     The objective of the present study is to investigate the effect dexamethasone and hyaluronic     acid have on hearing preservation   "
129588|NCT01588912|"     Oral antiviral drugs which can be given to patients with HBeAg-positive chronic hepatitis B     include Lamivudine, Clevudine, Adefovir, Telbivudine, Entecavir and Tenofovir. 2009 American     Association for the Study of Liver Disease (AASLD) Treatment Guidelines and 2009 European     association for the Study of the Liver (EASL) Treatment Guidelines recommend the     administration of Entecavir or Tenofovir with high potency and low resistance. Lamivudine has     low antiviral potency and high incidence of mutation in long-term administration compared to     Entecavir or Tenofovir. Clevudine causes the elevated creatinine kinase (CK), side effects     including myositis/myopathy and much mutation in the long-term administration. Globe study     demonstrated Telbivudine had more excellent antiviral potency than Lamivudine, which was also     comparable to or higher than Entecavir or Tenofovir. Nevertheless, the choice of treatment     drugs can be limited due to the mutation rate of 25% for 2 years. However, the analysis of     Globe study results showed that 2-year treatment progress was very good in patient who showed     virologic response at 24 weeks after the initiation of treatment and that high antiviral     potency and low mutation rate were observed when the Telbivudine roadmap strategy (in the     event that virologic response is shown at 24 weeks, telbivudine monotherapy is maintained and     in the event that virologic response is not shown, tenofovir add-on therapy is done) recently     implemented and announced in 2011 Asian Pacific Association for the Study of the Liver     (APASL) was applied. However, the study was single arm study, which restricted the comparison     between Entecavir and Tenofovir monotherapy groups. Therefore, this study intends to compare     the anti-viral effect and mutation rate between Entecavir 0.5mg monotherapy group and     Telbivudine roadmap strategy group in patients with HBeAg-positive chronic hepatitis B     through a randomized study.   "
129592|NCT01588860|"     Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and     constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High     prevalence in southeast and eastern Asia has been observed. At present, the cellular and     molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.      The RAS gene product has a key role in controlling cell growth and differentiation through     its intrinsic GTPase activity. Point mutations that activate the RAS protein and its     downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the     RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals.     Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer     and lung cancer. Studies from European and Japanese groups have recently described that     activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma     of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF     mutation in the same tumor as well as the results from Thailand. In this study, the     investigators hypothesize copy number changes rather than genetic mutation of either KRAS or     BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary     tracts.   "
129593|NCT01588847|"     Studies in animals and retrospective studies in humans show that regional anesthesia reduces     metastatic cancer dissemination.      The investigators hypothesize that in patients suffering from malignant melanoma who have to     undergo radical inguinal lymph node dissection immune function will be less compromised and     long term survival will be superior when spinal anesthesia is compared to general anesthesia.   "
129594|NCT01588834|"     The investigators hypothesize that knowledge of the functional behavior of areas of     mammographic density will enable more specific identification of dense tissue at-risk for     breast cancer, ultimately providing predictive information on an individual's risk of     developing breast cancer.   "
129595|NCT01588821|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug to learn whether the drug works in treating a     specific cancer. Investigational means that the drug is still being studied and that     research doctors are trying to find out more about it-such as the safest dose to use, the     side effects it may cause, and if the drug is effective for treating different types of     cancer. It also means that the FDA has not approved the drug for this type of cancer, or for     any use outside of research studies.      When cancer spreads from the primary tumor, one of the most commons sites it spreads to is     bone. When cancer spreads to bone there can be significant symptoms such as pain.      Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the     growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been     studied or is being studied in research studies as a possible treatment for various types of     cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney     cancer.      Previous clinical research studies indicate that cabozantinib may also have activity against     cancer once it has spread to the bones.      The purpose of this study is to find out if cabozantinib is effective in treating cancer that     has spread to the bone.   "
129596|NCT01588808|"     In the present study, the effects of 5 days of lower limb immobilization with or without     twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be     determined. A young group will be included to compare the changes in muscle mass and muscle     fiber characteristics between young and old men.   "
129597|NCT01588795|"     The DERENEDIAB study is a proof-of-concept, multi-center, prospective, open, randomized,     controlled study of the effectiveness of renal denervation in addition to standardized     medical treatment compared to medical treatment alone in diabetic subjects with diabetic     nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using     the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy     through the luminal surface of the renal artery.   "
129598|NCT01588782|"     The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for     drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is     co-administered with abiraterone acetate in healthy adult men.   "
129599|NCT01588769|"     It is the primary objective of this study to show safety and tolerability for administration     of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a     secondary objective to establish if any indications of positive therapeutic or palliative     effects may be observed.   "
129600|NCT01588756|"     The purpose of the study is to validate a new reference marker for evaluation of renal     function (glomerular filtration rate).   "
129601|NCT01588743|"     It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to     impairment in islet β-cell function and development of insulin resistance. A growing body of     evidence also indicates that this impairment inβ-cell function and insulin action could be     restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this     study, we are determined to use the golden standard of insulin sensitivity evaluation in     vivo—hyperinsulinemia euglycemic glucose clamp—to estimate insulin resistance improvement in     patients before and after intensive insulin therapy, investigate first phase insulin     secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin     secretion resulting from normalization of plasma glucose levels in both lean and obese     patients by insulin pump therapy.   "
129603|NCT01588717|"     The study consists of measurement of antidepressant-induced excessive sweating and its     treatment with an experimental medication, glycopyrrolate (approved to treat ulcers), which     will be added to the antidepressant. This is an open-label study (no placebo group or     concealment of the nature of the treatment) that will last 8 weeks, including two weeks of     baseline measurement without treatment with the study medication followed by six weeks of     treatment with the study medication. The study is pilot study by Dr. Rajnish Mago that is     based on the hypothesis that glycopyrrolate will be effective in reducing the severity of     excessive sweating caused by antidepressant treatment, and will have minimal side-effects.   "
129672|NCT01587794|"     Experimental retinal detachment and reattachment models have demonstrated the recovery     process of successfully reattached retina. However, optical coherence tomography analysis of     each retinal layers following retinal reattachment has not been investigated This study     investigated changes in thickness profiles of retinal layers after resolution of recent-onset     rhegmatogenous retinal detachment (RRD) using optical coherence tomography images.   "
129604|NCT01588704|"     The prognosis of patients with unresectable, locally advanced non-small cell lung cancer     (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer     drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern     targeted therapies have enhanced the outcomes of lung cancer treatment, especially for     advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is     bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF).     Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy     may change the previous treatment modality. It allows some lung cancer patients to be     downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be     improved.   "
129605|NCT01588691|"     Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury.     This study will specifically examine patients with mild traumatic brain injury (TBI) who have     persistent cognitive impairments lasting one year or longer. Neuropsychological testing will     occur to confirm the diagnosis.   "
129606|NCT01588678|"     DS-3078a will be evaluated as a single agent in subjects with advanced solid tumor     malignancies or lymphomas refractory to standard treatment or for which no standard treatment     is available.   "
129607|NCT01588665|"     The two specific aims of this study are 1) to assess the relative contributions of two major     maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to     the fetus, and 2) to determine the impact of maternal and fetal iron status on placental     transfer of these two iron sources in pregnant women and adolescents during the last     trimester of pregnancy.   "
129608|NCT01588639|"     This is a prospective, multi-center, open-label, non-interventional, 12-week study in people     with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin     R and SciLin M30 (alone or in combination) in routine clinical practice. The term study     insulins will be used in this protocol for these drugs and combinations.   "
129609|NCT01588626|"     The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active     metabolite, safety, tolerability of AZD6140 following single administration in healthy male     Japanese volunteers.   "
129610|NCT01588600|"     The effects of a dietary fiber on hunger and food intake will be tested in men and women.     Participants will receive fiber as part of a breakfast meal on two occasions. On another     occasion, participants will receive the same breakfast, without added fiber. Their feelings     of hunger and fullness will be measured over the day. They will be offered lunch, dinner and     an evening snack and how much they eat will be recorded. It is expected that the fiber     supplement will enhance their feelings of satiety and reduce the amount they eat over the     day.   "
129611|NCT01588587|"     Recently, DPP-IV inhibitors are used as a novel way to augment the incretin system and one of     the newest classes of medications in the treatment of type 2 diabetes mellitus (T2DM). Since     the DPP-IV inhibitor was first used, about 5 years have passed in USA. However, there were no     major side effects including occurrence of cancers. The main mechanism for DPP-IV inhibitors     is due to suppress the function of DPP-IV activity. As it is known that the suppressed DPP-IV     activity is a marker for early diagnosis of cancers, the reason of disassociation is not     clear.      Activation of receptor for advanced glycation endproduct (AGE) is related to sideration of     cancers. Meanwhile, the DPP-IV inhibitors may be related to inhibit the activation of     receptor for AGE (RAGE). Therefore, DPP-IV inhibitors may work as a cancer protective agent     in diabetes by blocking the AGE-RAGE axis.      However, it is not demonstrated why DPP-IV inhibitors have no side effect of occurrence of     cancer via blocking the activation of AGE-RAGE.      The investigators examined effect of DPP-IV inhibitors on frequency of cancers and the     underlying mechanism using AGE and RAGE before and 5 years after administration of DPP-IV     inhibitors in Japanese patients with T2DM.   "
129612|NCT01588574|"     The purpose of this study is to determine the Optimal dose for safety and efficacy in the     treatment of cervical dystonia.   "
129613|NCT01588561|"     In this study, we sought to explore brain activity in nicotine-dependent men in response to     acute intravenous nicotine using pharmacological magnetic resonance imaging (phMRI).   "
129614|NCT01588548|"     The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a     maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when     given daily to patients with advanced solid malignancies including malignant lymphoma   "
129615|NCT01588535|"     This study is to assess the reliability and validity of the FAECC scale to evaluate pain     associated with acute otitis media in children aged 2 months to 5 years.   "
129616|NCT01588522|"     This will be a dose escalation study to determine the maximum tolerated dose (MTD) and the     overall safety and tolerability of a topical compound 31543 (Calcitriol) in patients with     metastatic or recurrent cancer who are undergoing chemotherapy with a taxane-based regimen.   "
129617|NCT01588509|"     The purpose of this study is to estimate the percent change from baseline in lumbar spine     bone mineral density (BMD) following multiple-dose administrations of romosozumab in     postmenopausal women with low BMD previously treated with alendronate.   "
129618|NCT01588496|"     A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in     patients with homozygous familial hypercholesterolemia (HoFH).   "
129655|NCT01588015|"     This randomized phase I trial studies the side effects of vaccine therapy in preventing     cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor     stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body     build an effective immune response and prevent or delay the recurrence of CMV infection in     patients undergoing donor stem cell transplant for hematological malignancies.   "
129673|NCT01587781|"     This study is about a drug called enoxaparin which is used to prevent or treat blood clots.     There are no studies about the use of this drug in obese adolescents and yet the     investigators use it to prevent clots when they have surgery at Children's National for     weight loss. The investigators hypothesis is that the obesity leads to increased kidney size     and faster drug clearance. Therefore the investigators think they might be underdosing these     adolescents. This study will check the drug levels at different points after the drug dose to     see whether the investigators are achieving the expected levels for prevention of clots.   "
129619|NCT01588483|"     Giant cell arteritis (GCA) is the most frequent vasculitis in patients above 50 years of age.     The disease has limited mortality, mostly due to the development of aortic aneurysms, leading     to dissection and rupture. The probability to develop this complication is 17 x higher at the     level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in patients with     GCA when compared with a control group. Therefore, follow-up of the aortic diameter in     patients with GCA is part of good clinical practice. Previous retrospective research showed a     link between FDG-uptake at the level of the thoracic aorta, on positron-emission-tomography     (PET) at the time of diagnosis, and the increase of diameter and volume of the thoracic aorta     during follow-up (on computed tomography (CT)).      The purpose of this prospective study is to follow-up on the aortic diameter, and to     correlate these measures with FDG-PET uptake at diagnosis. Ideally, this would allow us to     define a group of patients at high risk to develop an aortic aneurysm, already at the time of     diagnosis.   "
129620|NCT01588470|"     The purpose of this study is to examine the existence of heart abnormalities in patients with     diabetes and the effect of pioglitazone in correcting these abnormalities.   "
129621|NCT01588457|"     The purpose of this study is to compare which of the two mood stabilizers (drugs that help to     steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is     more effective in patients with bipolar disorder over 26 weeks. The study will also compare     if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus     lithium or divalproex used with lamotrigine is more effective when symptoms of depression     develop.   "
129622|NCT01588444|"     The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft     (FDBA) materials in the preservation of alveolar bone following extraction of non-molar     teeth. The primary objective is to histologically evaluate and compare the healing of     extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for     ridge preservation.   "
129623|NCT01588431|"     Locally advanced squamous cell carcinoma of the head and neck (SCCHN) is treated with various     combinations of radiation and chemotherapy. This study aims to evaluate the rate of complete     responses with induction therapy (primary endpoint) and progression-free survival, overall     survival and objective response rates of docetaxel, cisplatin, cetuximab, and bevacizumab     (TPE-A) followed by radiation therapy, cisplatin, cetuximab, and bevacizumab (XPE-A). Also,     the investigators plan to investigate a panel of EGFR and angiogenesis biomarkers in pre-and     post- treatment tumor biopsies. Finally, the investigators will evaluate the associated     treatment toxicities and the quality of life.   "
129624|NCT01588418|"     This research study will examine brain glucose metabolism after an overnight fast to     determine the effect of exenatide on brain glucose metabolism and lipid metabolism.   "
129625|NCT01588405|"     This multi-center, open-label study will assess the tolerability and safety of transitioning     subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV)     or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR)     tablets).      This study will consist of an in-hospital transition phase, dose optimization/evaluation     phase, and follow up phase.   "
129626|NCT01588392|"     The purpose of this study is to examine if short bouts of structured physical activity     implemented within the classroom setting as part of designated gross-motor playtime will     increase preschool-age children during-school physical activity level.   "
129627|NCT01588379|"     The purpose of this study is to examine the feasibility and efficacy of a 12-week afterschool     afro-centric dance physical activity program for daughters and mothers on the physical     activity level of African-American girls.   "
129628|NCT01588366|"     This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of     LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study     will image the liver using magnetic resonance imaging (MRI) and magnetic resonance     spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus,     when they take LY2409021 to see if liver changes happen at the same time as changes in blood     tests. This study is approximately 11 weeks long, not including screening. A screening     appointment is required within 28 days prior to the start of the study.   "
129629|NCT01588353|"     To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.      To determine plasma concentration after the first injection of AK160 in patients with     Dupuytren's Contracture.   "
129630|NCT01588340|"     The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring     sedation to ultrasound in the assessment of hydronephrosis.   "
129631|NCT01588327|"     The ability to explain bleeding or clotting complications in patients treated with dabigatran     remains challenging. In addition, there is limited data on how coagulation tests perform in     patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation     tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal     responses to dabigatran. The purpose of the study is to define a therapeutic reference range     for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and     to determine which tests may be most clinically useful for monitoring dabigatran.   "
129632|NCT01588314|"     The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling     peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid     analgesics. The investigators are conducting a randomized, double-blind, placebo controlled,     single center, cross-over study. The primary endpoint is percent reduction in patients' use     of hydrocodone-acetaminophen.   "
129656|NCT01588002|"     This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study     will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose     ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple     oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all     subjects will receive multiple oral doses of the combination danoprevir with ritonavir and     efavirenz for 14 days. Anticipated time on study treatment is 28 days.   "
130156|NCT01581385|"     This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging     method, Acoustic Radiation Force Impulse (ARFI) ultrasound, to describe the composition and     structure of atherosclerotic plaques. The hypothesis being tested is that in vivo,     transcutaneous ARFI ultrasound delineates plaque composition and structure in human carotid     arteries.   "
129633|NCT01588301|"     Scientific Context:      High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer.     Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's     well-known that this test has significantly contributed to the reduction of mortality and     morbidity due to cervical cancer. In France, it now seems that the screening strategy could     be optimized. The two main ways are to reach the 7 million underscreened women (organized     screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA     testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA     testing could be a relevant screening option: this technique appears reliable and it could     allow to reach women who are never or seldom screened. The performance of the SCVS to detect     cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.      The goal of this study is to compare the attitudes of women not attending organized cervical     cancer screening face to different strategies: further invitation to make a cervical smear or     kit for self-collected vaginal sample sent at home.      Description of the project :      Nine months after a primary invitation to make a cervical smear, a random sample of 6000     women not attending organized cervical cancer screening will be randomly assigned to one of     the following arms:        -  Intervention arm 1:      Women will receive a further invitation to make a cervical smear        -  Intervention arm 2:      Women will be directly sent the kit for self-collected vaginal sample at home. The women who     will send the self-sample to the laboratory for analyse will receive their results at home as     well as their general practitioner if the HPV DNA test is positive (infection by a high-risk     HPV).      For them who will have a HPV DNA test positive, it will be necessary to complete the     screening action with a cervical smear. That's why those women will receive an invitation to     make a cervical smear if they won't do it during the 9 months following the first mail.        -  Control arm: Those women will receive complete information about the study, the main          results and the screening recommendations at the end of the study.   "
129634|NCT01588288|"     The investigators will dose galectin 3 in plasma and water rinse of the needle aspiration     biopsy in patients with thyroid nodules. The investigators aim to show that preoperative     dosage of the galectin 3 could provide good diagnosis of malignant versus benign thyroid     cancer.   "
129635|NCT01588275|"     The purpose of this study is to compare the cost-effectiveness and effectiveness of     mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP)     therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).   "
129636|NCT01588262|"     A life threatening disease such as cancer may lead to post traumatic stress disorder, and     even when reporting low levels of side-effects from cancer disease and treatment, 80% report     high levels of stress symptoms. The purpose of the present randomised controlled trial is to     examine the psychosocial effects of a stress management intervention based on cognitive     behaviour therapy and with focus on increased physical activity in patients with various     cancer diagnoses using a stepped-care approach. When using a stepped-care approach it is     possible to study the level and intensity of stress management intervention required to     achieve increased well-being. A cost-utility analysis will also be performed. 300 adult     patients with a recent diagnosis of breast-, colorectal- prostate, testicular cancer or     lymphoma and scheduled for adjuvant and/or curative oncologic treatment at Haukeland     University Hospital, will be consecutively included in the prospective intervention study.     The patients will be randomized to intervention or control. In step 1, all patients in the     intervention group (I-a) will receive 2 counselling sessions. Patients who report clinically     significant levels of stress, such as intrusive thoughts/avoidance behaviour (measured by     Impact of Event Scale) and/or worry and depressions (measured by Hospital and Depression     Scale) will be included in Step 2 (I-b) and include another 4-7 counselling sessions. There     will also be a focus on motivating to increase physical activity level. Both the intervention     (I) and control group (C) are allowed to take part in the common rehabilitation program with     patient education and physical training. Data will be collected with self-reported     standardized questionnaires. Objectively measures of physical activity level, sleep and daily     energy expenditure are recorded with SenseWear™ Pro3 Armband. Measure point is at inclusion     and than after 6 week, 4, 8, 12 and 24 month.   "
129637|NCT01588249|"     Cough is a frequent symptom in children and infants and is one of the most common reasons     parents visit a healthcare provider for their child. The US Food and Drug Administration has     issued a warning that over-the-counter cough and cold medicines including antihistamines,     decongestants, anti-tussives, and expectorants should not be administered to children younger     than 2 years of age due not only to lack of proven efficacy, but also because of important     safety concerns. A product that has been used in alternative medicine for cough is maple     syrup. Although no studies have formally evaluated the use of maple syrup for nocturnal cough     associated with URI, the demulcent effect of maple syrup may provide some relief from cough     in children. A novel formulation of pasteurized maple cough syrup, when compared to placebo,     should provide superior relief on nocturnal cough and the sleep difficulty associated with     URI in children under 12 months and sleep difficulty of their parent/caregiver.   "
129638|NCT01588236|"     The purpose of this study is to further assess the efficacy, safety and dose-response of     KYG0395 in the treatment of primary dysmenorrhea.   "
129639|NCT01588223|"     The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that     can predict endometrial receptivity.   "
129640|NCT01588210|"     The hypothesis of this study is that the concentration of fluoride in oral interproximal     fluids would increase more after using high-viscosity GIC as pit and fissure sealant,     compared to Resin-Based sealants containing fluoride and RB sealants without fluoride     content. To validate this hypothesis a randomized clinical trial was designed and performed     in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after     the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing     fluoride and RB sealants without fluoride content.   "
129641|NCT01588197|"     The purpose of this study is to determine whether real-time functional magnetic resonance     imaging may be a viable treatment for chronic pain in the future.   "
129642|NCT01588184|"     This single-arm, open-label, multicentre extension study will provide continued Avastin     [bevacizumab] therapy to patients with solid tumours who were previously enrolled in a     Roche/Genentech sponsored study and who derived benefit from the Avastin therapy. Patients     will receive the same dose and regimen as used in the previous parent trial and continue this     treatment until disease progression or unacceptable toxicity.   "
129643|NCT01588171|"     The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH     (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for     venous thrombosis.   "
129657|NCT01587989|"     This multicenter study with a randomized, double-blind, parallel-group phase will evaluate     the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate     versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis,     with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg     intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients     with a good/moderate EULAR response will then be randomized to receive either     RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12     weeks. Anticipated time on study treatment is 6 months.   "
129658|NCT01587976|"     The purpose of this trial is to study health related quality of life (HQoL)after resection of     colorectal liver metastases combined with perioperative chemotherapy. The investigators want     to study if an aggressive, life prolonging and multimodal treatment can be defended from a     quality of life perspective.   "
129659|NCT01587963|"     The purpose of this study is to determine the effectiveness of high doses of Vitamin C in     critically ill patients.   "
129644|NCT01588158|"     Adequate pain relief has been a priority of the Joint Commission and is featured on national     inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction     with pain relief in the United States, a great deal of emphasis has been placed on opioid     pain medications. Some of this emphasis on opioid pain medication is driven by the     pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry.      There is evidence that the pain is the fifth vital sign campaign of the Joint Commission     led to an increased incidence of prescription of opioids, but there is less evidence of     improved satisfaction with pain relief. There is some evidence of an increase in     opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has     the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the     Emergency Department for opioid overdose doubled between 2004 and 2008.      Patients in other countries take far less opioid pain medication and are equally satisfied     with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch     patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and     have comparable or better satisfaction with pain relief than American patients, most of whom     take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch     patients do not feel their pain is undertreated. A study of morphine use after a femur     fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg     versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological     differences are striking and suggest strongly that personal factors may be the most important     determinant of satisfaction with pain relief.      It is our impression that most American hand surgeons give patients a prescription for an     opioid pain medication after carpal tunnel release, and that is certainly true in our     practice. This seems to be based primarily on the outliers, and intended to avoid     confrontation with patients that desire opioids; however, most patients take little or no     narcotic pain medication, and many who do use the opioids complain of the side effects—nausea     and pruritis in particular. It is therefore not clear whether routine opioids is the optimal     pain management strategy after carpal tunnel release. In the study of Stahl et al. from     Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel     release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen     or other pain medication at all after the operation.      Our aim is to determine if there is a difference in satisfaction with pain relief between     patients advised to take opioids compared to patients advised to use over the counter     acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to     determine if personal factors account for more of the variability in satisfaction with pain     relief than opioid strategy.   "
129645|NCT01588145|"     The main objective of this study is to evaluate the safety and tolerability of HM61713.   "
129646|NCT01588132|"     In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of     Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical     evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and     low bleeding potential in healthy human subjects.   "
129647|NCT01588119|"     Patients, who are adjusted to a new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban,     Edoxaban) in routine treatment will recorded in this register. Within this register a     characterization of patients (with regard to demography and indication) and therapy (with     regard to medication, dose and duration) will be done. On basis of defined clinical relevant     end points the long-term efficacy and safety will be evaluated.   "
129648|NCT01588106|"     The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with     AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE)     enables behavioral changes that may lead to improvement in glycemic control, expressed as a     reduction in HbA1c as primary endpoint.      Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be     trained in using the devices and return every 3 months until month 9 after baseline.   "
129649|NCT01588093|"     Hormonal disturbances in the GH-IGF-I axis are considered important for the deterioration of     glycemic control in T1DM particularly in adolescents. In addition it may have direct     implications on the development of insulin resistance and long-term complications.      The Investigators hypothesis is that low circulating IGF-I and compensatory hyper-secretion     of GH, in the presence of peripheral insulin excess, results in increased local IGF-I     expression explaining both the deterioration in metabolic control and the increased risk for     microvascular complications. Correction of imbalance in circulating and tissue-specific     levels of IGF-I could lead to both better early metabolic control and to prevention of early     diabetic complications in type 1 diabetic (T1DM) patients.      Aim of the present study is to validate the microdialysis technique as a useable tool to     predict local biological effects of IGF-1 and to understand the pharmacokinetics of local     IGF-I actions after sc injection of Increlex in type 1 diabetic patients.   "
129650|NCT01588080|"     When babies are born premature, they often need help with their breathing. The equipment used     to help them breathe is not very comfortable and they sometimes need to be put on a     specialized breathing machine with a tube into their lungs. The breathing machine or     ventilator can be damaging to the newborn's lungs and more damage can occur the longer the     newborn stays on a ventilator leading to chronic lung disease later in their lives. A new     device called neurally adjusted ventilatory assist or NAVA is available that the     investigators believe may be more comfortable for the premature newborn and may help the baby     come off breathing support sooner. When using this device, babies may not need to be put on a     ventilator and can avoid the lung damage associated with the breathing tube and the     ventilator. The objective of this pilot study is to compare this new breathing device called     NAVA, to the equipment that is currently being used, called SiPAP, to support premature     newborn's breathing after birth without a breathing tube. The investigators hope to show that     with this new technology, premature newborns that are having a difficult time breathing, will     come off breathing support sooner compared to the breathing machines that are currently being     used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA     will decrease time spent on noninvasive ventilation and avoid intubation.   "
129651|NCT01588067|"     This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD)     patients undergoing lower extremity revascularization to describe the population and assess     comparative effectiveness of endovascular therapy versus surgery. In addition, this study     will conduct a prospective cohort study of patients treated medically or undergoing lower     extremity revascularization at the VA and Kaiser Colorado to compare changes in health     status.   "
129652|NCT01588054|"     The purpose of this study is to define clinical and demographic features within the     population suffering from cervical deformity to assist health professionals to make important     treatment decisions.   "
129653|NCT01588041|"     The purpose of this study is to investigate the use of optical coherence tomography imaging     integrated with an operating microscope (MIOCT) in ophthalmic surgeries.   "
129654|NCT01588028|"     CH5424802 is a newly invented, selective oral ALK inhibitor. In the Phase I portion, the goal     is to determine the following: dose limiting toxicity, the maximum tolerated dose,     pharmacokinetic (PK) parameters, and the recommended dose.   "
129660|NCT01587950|"     A randomized, controlled, double blind exploratory study to explore the effects of two     different potassium nitrate concentrations and water on exposed dentine in reducing dentinal     hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by     visual analogue scale (VAS) scores following evaporative (air) stimulus.   "
129661|NCT01587937|"     Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic     resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in     hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has     published guidelines stating that all hospitals should develop an institutional program to     enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic     stewardship audit-and-feedback intervention for all patients reaching their third or tenth     day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic     use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The     investigators hypothesize that this intervention will result in similar benefits outside of     the intensive care unit, and so expanded the intervention to non-ICU medical and surgical     wards. To increase the rigor of our program evaluation, the roll-out was conducted in a     stepped-wedge randomized controlled design.   "
129662|NCT01587924|"     This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center     study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable     rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia     associated with chronic kidney disease. The study consists of a screening phase of 2 weeks, a     4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study     eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with     total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening     visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and     Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic     kidney disease after switching from a stable maintenance dose of recombinant human     erythropoetin (rhEPO).   "
129663|NCT01587911|"     Assessing 5 different milk derived proteins versus placebo for appetite regulation and     satiety, delivered via shake vehicle.   "
129664|NCT01587898|"     This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group,     multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in     approximately 68 subjects with anemia associated with chronic kidney disease who are not     taking rhEPO and are not undergoing dialysis. The range of Hgb values for study eligibility     is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once     daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion.   "
129665|NCT01587885|"     This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination     product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent     heartburn.   "
129666|NCT01587872|"     The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors     can make the procedure difficult, and sometimes a complete examination is not possible.     Complicating factors include poor bowel preparation and technical challenges such as     differences in anatomy (long, redundant colonic segments), post-surgical adhesions,     strictures and diverticulosis. A special endoscope with two inflatable balloons, originally     designed to examine the small bowel, has been used for several years with success in such     technically difficult colonoscopies. More recently a modified double-balloon instrument was     designed specifically for colonoscopy, but the documentation of the performance of this     instrument is limited. The aim of the present study is to investigate the performance of the     double-balloon colonoscope in cases where conventional colonoscopy have failed due to     technical difficulties.   "
129667|NCT01587859|"     Background:      The existence, diagnosis and treatment of short esophagus is one of the controversies of the     past which has recently re-emerged. The missed diagnosis of short esophagus and the     consequent inadequacy of treatment is one of the major causes of failure of antireflux     surgery.      The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could     take advantage of the definition of frequency, preoperative predictors, intraoperative     management and post operative outcomes of cases of foreshortened esophagus, in order to offer     the patient affected by GERD the elements necessary for a conscious choice of therapy and to     plan the best performance of the surgical procedure.      Aims of the Study To define the percentage of cases among the total of antireflux procedures     performed for type II-IV hiatus hernia, in which, after standard isolation of the ge junction     and dissection of the mediastinal esophagus at least two centimetres of esophagus can not be     replaced without any applied tension below the apex of the diaphragmatic hiatus.   "
129668|NCT01587846|"     Beneficial therapeutic effect of probiotics has been reported in children with irritable     bowel syndrome, but not consistently in other functional gastrointestinal disorders. Although     there is evidence that probiotics increase stool frequency and decrease stool consistency in     healthy individuals the evidence for efficacy in constipation is limited.      Children with functional abdominal pain (FAP) and constipation will be included in the study.     Children with FAP will be randomized in one of two groups and will receive either L. reuteri     in a daily dose of 108 CFU, or placebo during three months. Children with chronic     constipation will receive either L. reuteri in a daily dose of 108 CFU and lactulose, or     placebo and lactulose. Frequency and intensity of episodes of abdominal pain during and after     intervention will be recorded in children with FAP. Frequency of defecation, stool     consistency and need for lactulose will be recorded in children with chronic constipation.   "
129669|NCT01587833|"     The studies described in this protocol are all performed within the framework of PROTECT     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and     disseminate methodological standards for the design, conduct and analysis of     Pharmacoepidemiological (PE) studies applicable to different safety issues and using     different data sources. To achieve this, results from PE studies on five key adverse events     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the     methodological aspects of the studies in this protocol and not on the clinical consequences     of the association under investigation.      Benzodiazepines (BZDs) are one of the therapeutic groups most widely used, mainly indicated     as hypnotics and anxiolytics. Guidelines recommend treatment courses not exceeding 4-6 weeks.     However, long-term treatment is highly prevalent, particularly in older people with a     prevalence ranging from 15 to 30%. However, treatment is often taken as needed.      Hip/femur fractures are a major cause of morbidity and mortality, impair quality of life and     impose a considerable economic burden. Among people aged 50 years and older, a case-fatality     rate of 20% is associated within the first year.      The relationship between benzodiazepines and hip fractures remains controversial.     Psychotropic medication has been traditionally associated with hip fractures. Among     psychotropic medication, long elimination half-life benzodiazepines were found to increase     the risk of hip fractures in a case-control study published in the late eighties. Since then,     several investigations have been performed, mostly in older patients focusing on the     relationship between benzodiazepines and hip fractures, and between benzodiazepines and falls     as a mechanism underlying this effect. A review performed in 2003, which included 11     epidemiological studies, reported that results were not always consistent. Seven out of eight     cohort and population based case-control studies, found an association, but different results     were reported according to benzodiazepines' half-life. In four hospital-based case-control     studies no association between benzodiazepines use and hip fracture has been described. Data     on dosing was only included in three of the studies, and once more results were not     conclusive. Results ranged from no effect to an increased risk with high dose regimens.     Results from subsequent succeeding studies have also shown contradictions, with no     association reported in one of the studies, and an association described for the short-term     use of short half-life, high-potency benzodiazepines.      Even though there is epidemiological evidence suggesting that the use of benzodiazepines     increases the risk of hip fractures, problems rise with the definition of benzodiazepine     exposure, or biases such as confounding by indication and the control for confounders. These     remain unresolved topics that should be addressed in future studies. In the present protocol,     it is proposed to further asses the risk of hip/femur fractures associated with     benzodiazepines using different study designs in different primary databases, and to compare     the results in order to evaluate the impact of design and population differences on the     outcome of the study association.      The objective of this study is to assess the association between benzodiazepines use and     hip/femur fracture with different study designs (descriptive, cohort, nested case-control,     case crossover and self control case series) across different primary care databases     (Bavarian, Mondriaan, National Databases (Denmark), General Practice Research Database     (GPRD), Base de Datos para la Investigación Farmacoepidemiologica en Atencion Primaria     (BIFAP) and The Health Improvement Network (THIN)) and to compare the results between     databases, across designs to evaluate the impact of design/database/population differences on     the outcome of the studied association.   "
129670|NCT01587820|"     This is a randomized, open-label investigator initiated pilot/ feasibility study comparing     the effectiveness of intra-arterial administration of cisplatin therapy to intravenous     administration of cisplatin when each is combined with the radiation therapy found in     standard care. Participants will be randomized to either intra-arterial or intravenous     cisplatin chemotherapy. This study is designed to determine whether a large scale study is     practical in the investigators clinical setting. Approximately 10 subjects will be enrolled     over a 2 year period.   "
129671|NCT01587807|"     GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The     purpose of this study is to investigate the safety, tolerability and pharmacokinetics of     inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a     single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a     single-dose, parallel group design comprising 2 groups of healthy subjects assessing the     effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose     administered in Part 2 will be determined from emerging safety and PK data from Part 1 and     Study TFR110951.   "
129674|NCT01587768|"     The studies described in this protocol are all performed within the framework of PROTECT     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)     Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test and     disseminate methodological standards for the design, conduct and analysis of     Pharmacoepidemiological (PE) studies applicable to different safety issues and using     different data sources. To achieve this, results from PE studies on 5 key adverse events     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the     methodological aspects of the studies in this protocol and not on the clinical consequences     of the association under investigation. The standards to develop will contribute to     decreasing the discrepancies in results from different studies in the future and increase the     usefulness and reliability of these studies for benefit-risk assessment in the EU.      We propose to assess the association between antibiotics use and idiopathic acute liver     injury with different study designs (descriptive, cohort, nested case-control and case     crossover) across different primary care databases and to compare the results between     databases, across designs to evaluate the impact of design/database/population differences on     the outcome of the studied association.      Specific aims (in each database):        1. To describe characteristics, clinical features, and risk factors for acute liver injury          in patients exposed and unexposed to antibiotics.        2. To estimate the overall risk of acute liver injury associated with antibiotics exposure          (users and non-users) in each database        3. To estimate the risk of acute liver injury associated with various antibiotics classes        4. To estimate the risk of acute liver injury associated with specific individual          antibiotics        5. To assess the effect of dose and duration of use for specific individual antibiotics.        6. To compare the results of a case-control study with the results of a retrospective          cohort study and self-controlled case series study in the different databases      The proposed studies will be collected in populations from the following databases: The     General Practice Research Database [GPRD] (UK), Health Improvement Network [THIN] (UK), BIFAP     [Base de datos Informatizada para estudios Farmacoepidemiologicos en Atencion Primaria]     (Spain)- the Bavarian Claims Database (Germany), Mondriaan (Netherlands), and the National     Databases of Denmark.   "
129675|NCT01587755|"     A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together     with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.   "
129676|NCT01587742|"     The studies described in this protocol are all performed within the framework of PROTECT     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)     Workpackage 2 (WP2) and Workgroup 1. The primary aim of these studies is to develop, test and     disseminate methodological standards for the design, conduct and analysis of     Pharmacoepidemiological (PE) studies applicable to different safety issues and using     different data sources. To achieve this, results from PE studies on 5 key adverse events     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the     methodological aspects of the studies in this protocol and not on the clinical consequences     of the association under investigation. The standards to develop will contribute to     decreasing the discrepancies in results from different studies in the future and increase the     usefulness and reliability of these studies for benefit-risk assessment in the EU.      Within WP2, five possible adverse event - drug pairs have been selected for analyses; one of     these includes the possible role of calcium channel blockers (CCBs) in the risk of cancer.     Analyses will address the hypothesis that CCBs modify the risk of cancer (all forms of cancer     combined and various groups of cancers).      This hypothesis will be investigated using two sources of data: the UK General Practice     Research Database (GPRD) and the Danish national databases. Investigations in the UK may also     use The Health Improvement Network (THIN).      The primary objective of the study is to investigate the possible association between use of     CCBs and risk of all forms of cancer combined, among adult patients (18 to 79 years of age     during the study period, January 1, 1996 to December 31, 2009). The study will be conducted     using three databases with different study designs (descriptive, cohort, population based     cohort study and nested case-control) across different databases (GPRD, THIN, Danish     databases) and to compare the results between databases, across designs to evaluate the     impact of design/database/population differences on the outcome of the studied association.      Secondary objectives are to investigate the potential association between use of CCBs and     risk of all forms of breast cancer in women; all forms of prostate cancer; and all forms of     colon cancer using the same age groups and databases).   "
129677|NCT01587729|"     The studies described in this protocol are all performed within the framework of PROTECT     (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium)     Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and     disseminate methodological standards for the design, conduct and analysis of     Pharmacoepidemiological (PE) studies applicable to different safety issues and using     different data sources. To achieve this, results from PE studies on five key adverse events     (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the     methodological aspects of the studies in this protocol and not on the clinical consequences     of the association under investigation.      Fracture of the proximal end of the femur or hip is associated with considerable morbidity     and mortality. Hip/femur fractures impair quality of life and impose a considerable economic     burden, and occur with 20% mortality rate within the first year. Antidepressants (AD), mainly     tricyclic AD (TCAs) and selective serotonin re-uptake inhibitors (SSRIs) have been associated     with fractures in several studies. A review of 13 observational studies showed risk ratios     ranging from 1.2 to 3.7 for current TCA users and a wide range of 1.5 to 8.6 for SSRI users.     The majority of the studies in the aforementioned review reported increased risks of     fractures in general with SSRIs use and more mixed risk outcomes for TCA use. Several     mechanisms underlying this adverse effect have been postulated in the literature: e.g.     through decrease in bone mineral density (BMD) or through blocking the serotonin transporter     activity (5-hydroxytryptamine re-uptake) and hence affecting bone metabolism and structure or     simply by falling or through co-morbidities such as depression itself. Previous observational     studies differ in design, conduct and analysis of the considered association with varying     degree of accounting for confounders. Confounding factors such as depression and other     co-morbidities, previous fractures, concomitant drug use and lifestyle factors such as     smoking have usually not been accounted for in most of the studies. In addition, small sample     size, different methods used to ascertain exposure, selection bias and lack of data on     compliance as well as important covariates limit the use of these results in benefit-risk     analyses. Furthermore, studies evaluating different types of SSRI and TCA are few and     dose-response relationship for most of the AD remains to be studied. We will study effects of     cumulative exposure focusing on acute (less than 6 months) and long term exposure (at least 5     years) and doses of exposure.      The objective of the study is to assess the association between AD use and hip/femur fracture     using different study designs (descriptive, cohort, nested case-control and case crossover)     across different databases and to compare the results between and across databases and     designs. This is to evaluate the impact of design/database /population difference in the     outcome of the studies association.      Data will be collected from the following databases: The Health Improvement Network [(THIN]),     a UK-based primary care electronic medical record database, the Dutch Mondriaan project (a     primarily general physician based database with some linkage to survey data from the     Netherlands), Base de Datos para la Investigación Farmacoepidemiológica en Atencion Primaria     [(BIFAP] (Spanish primary care database)), and the Bavarian statutory health insurance     physicians' association database (German health insurance database from primary and secondary     care).   "
129678|NCT01587716|"     This is a study of the sodium channel inhibitor, GSK2339345. Cohort 1 will assess the safety,     tolerability and PK of single ascending doses of GSK2339345 administered via an aqueous     droplet inhaler in healthy subjects. Cohort 2 will assess the safety, tolerability, and PK of     repeat doses of GSK2339345 administered four times a day for two consecutive days via an     aqueous droplet inhaler.   "
129679|NCT01587703|"     This study is divided into two parts; Part 1 of the study is a dose escalation phase to     select the recommended dose for Part 2 based on the safety, pharmacokinetic, and     pharmacodynamic profiles observed after oral administration of GSK525762 in the following     subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal     cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple     negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and     MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability,     pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1     in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate     cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER     positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1     and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part     1 to approximately 10-12 subjects in the United States to investigate the relative     bioavailability of the besylate tablet compared to the amorphous free-base tablet at the     maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat     high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the     dose proportionality of two doses of GSK525762 administered as besylate tablet.   "
129680|NCT01587690|"     MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in     many human diseases. The purpose of this pilot study is to determine if microRNA expression     is changed in untreated and interferon-beta-treated patients with multiple sclerosis.   "
129718|NCT01587196|"     The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers     predicting drug use during and after treatment in 72 subjects addicted to prescription     opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active     medication. The brain fMRI measures will be correlated with the primary clinical outcome of     drug use (by urine drug screen) during the treatment and follow-up phase.   "
131038|NCT01569828|"     An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and     its metabolites in subjects with severe renal impairment compared to matched healthy subjects     with normal renal function   "
129693|NCT01587521|"     Patients with schizophrenia are more likely to have metabolic syndrome compared to general     population. The criterion for metabolic syndrome in Asian people including: elevated waist     circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL     cholesterol: male < 40mg/dL, female < 50mg/dL, elevated blood pressure: ≥ 130/85 mmHg,     elevated fasting glucose: ≥ 100mg/dL. Several factors have been found to be associated with     metabolic syndrome in schizophrenia, e.g. age, antipsychotic drugs, smoking, family history     of metabolic disorder, stress, and quality of life.      However, little is known about the prevalence of and factors associated in Asian. This study     aimed to:        1. Identify the prevalence of metabolic syndrome in patients with schizophrenia.        2. Identify the factors associated with metabolic syndrome in patients with schizophrenia.   "
129694|NCT01587508|"     The purpose of this study is to assess the efficacy end tolerability of a new drug containing     the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the     treatment of acute lumbago.   "
129681|NCT01587677|"     Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.     Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis     require advanced and expensive diagnostic methods that restrict their availability in     resource limited countries where the burden of tuberculosis is highest. The development of     rapid point of care diagnostics is required.      Lipoarabinomannan (LAM) is part of the bacterial cell wall in M. tuberculosis. It is released     when bacteria are multiplying or dying. LAM can be detected in the urine since it is filtered     from the blood in the kidneys. The detection of LAM in the urine by conventional enzyme     linked immuno-sorbent assay (ELISA) techniques was hampered in the past by a low sensitivity     and multiple processing steps. Recently, fluorescence linked immuno-sorbent assay (FLISA) has     been shown to detect LAM in concentrations that are several magnitudes lower that with ELISA     based methods. Furthermore the procedure requires less separate steps for processing the     sample.      This study aims to validate the new diagnostic test by comparing patients with (a) confirmed     tuberculosis (n=25), (b) infection with non-tuberculous mycobacteria (n=25), (c) bronchial     carcinoma (n=25), (d) suspected tuberculosis but confirmed alternative diagnosis (estimated     n=20). Single blood and urine samples of these groups will be used to evaluate the     sensitivity and specificity of the test.      In patients with confirmed tuberculosis the LAM FLISA will also be assessed as a biomarker     for the monitoring of tuberculosis treatment success. Initially, 2-5 samples blood and urine     are required during the first week, followed by twice weekly and weekly sampling intervals     over a period of 12 weeks maximum. The study participation ends when the patient is     discharged from hospital.      As a substudy, the blood samples will be used to evaluate an enzyme linked immuno-sorbent     assay (ELISA) for the detection of lipid antigens that are specific for Mycobacterium     tuberculosis.   "
129682|NCT01587664|"     The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez     intra-laryngeal implant in patients with dysfunctional larynx.   "
129683|NCT01587651|"     This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized,     3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study     will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with     ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have     previously received ticagrelor loading does (LD) and maintenance dose (MD)..   "
129684|NCT01587638|"     This study used an observational, retrospective cohort design to compare the presence and     timing of new-onset diabetes (NOD) between hypertensive patients initiating therapy with     carvedilol immediate-release (IR) and carvedilol controlled-release (CR) vs the following     cardioselective beta blockers (BBs): atenolol, metoprolol succinate, and metoprolol tartrate     (referred to hereafter as 'other BB').      The aim of the study was to investigate the likelihood of developing NOD among hypertensive     patients initiating carvedilol therapy vs other BB therapy in a real world setting derived     from data contained in a large United States (US) managed care database.   "
129685|NCT01587625|"     In a randomized control trial conducted in six study centers/labour wards in Sweden,     consenting nulliparous women in active phase of labour and with a defined delayed labour     progress will be randomized to receive a regimen of either high or low dose of oxytocin.     Primary outcome is caesarean delivery rate. Secondary outcomes are: Apgar score, need of     neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate,     length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain,     epidural analgesia and the women´s childbirth experience one month postpartum (assessed with     Childbirth Experience Questionnaire). Study results will contribute to establish good     evidence-based routines regarding oxytocin treatment of delayed labour progress.   "
129686|NCT01587612|"     Hyperpronation is af frequent cause of excessive load in foot and crus. Pain and limited     functional ability cause problems with work-related activities, sport activities and leisure     activities.      There are only few studies of the frequency of pain related to hyperpronation in foot and the     effect of exercises. Medics and physiotherapists need sufficient evidence-based knowledge to     treat these patients correctly.      Therefore, the investigators want to study the effect of exercises and inner soles for     treatment of patients with chronic pain and hyperpronation of foot.   "
129687|NCT01587599|"     Design and Procedure:      The design is a randomised controlled multi-centre pilot study. 18 community pharmacies     located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an     intervention group. These pharmacies recruited eligible patients out of their clientele and     invited them to take part in the study. Participants were visited at home by the pharmacist     and home-based medication reviews were conducted. The survey form has been developed by the     research team and comprised amongst others items to adherence, adverse effects, drug intake,     storage and quality of life. Thereafter all data were analysed by the pharmacist with a newly     developed document called analysis guide aiming at the detection of drug related problems.     Pharmacists of the intervention group discussed the results with the family doctor of the     patients and the patients and tried to solve the drug related problems. This procedure was     not undertaken in the control group.      Six months later a second medication review was carried out in both groups.      Study hypothesis:      Pharmaceutical care reduces the overall number of drug-related problems of elderly patients     with diabetes and impairments in mobility.      Aim:      The purpose of this study is to show that pharmaceutical care reduces the overall number of     drug-related problems of elderly diabetes-patients with impairments in mobility and leads to     both an improved health status and an improved quality of life.   "
129688|NCT01587586|"     Primary objectives:      The purpose of this study is to determine and compare the sustained virologic response (SVR,     undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups.      To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment     groups.   "
129689|NCT01587573|"     The purpose of this study is to verify the discriminatory value of previously identified     salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use     population of patients with oral lesions suspicious for cancer.   "
129690|NCT01587560|"     The purpose of the study is to investigate fixation to bone and the clinical results     following shoulder resurfacing arthroplasty. The study will compare results between an     implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.   "
129691|NCT01587547|"     The purpose of this study is to develop an algorithm for embryo selection based on amino acid     profiling (AAP) of spent culture medium. Development of the algorithm will be based on the     ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound     scan in gestational week 7.   "
129692|NCT01587534|"     The investigators planned a prospective, randomized, placebo controlled trial to test the     hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of     the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in     combination with dietary counseling.   "
129696|NCT01587482|"     Nowadays, stenting is became a standard of care in revascularization for superficial femoral     artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains     in-stent restenosis (ISR). While most of local therapies have failed to demonstrate     significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous     transluminal angioplasty remains the current standard of care for this indication. Recent     studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo     lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to     evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA     atherosclerotic lesions.   "
129697|NCT01587469|"     This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a     longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for     pulmonary TB. The sensitivity and specificity of the Xpert MTB/RIF (Mycobacterium     tuberculosis/rifampin) assay performed on the first sputum collected for Xpert testing will     be compared to gold standard conventional culture methods on two sputum specimens, in     HIV-infected and HIV-uninfected participants.   "
129698|NCT01587456|"     The investigators planned to study relationship between osteoporosis and arterial rigidity     within fractured patients cohort.   "
129699|NCT01587443|"     End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and     social life, as well as overall quality of life (QoL). Health-related quality of life (HRQoL)     in dialysis patients measures the physical, social or emotional well-being that is affected     by ESRD and/or its treatment, and has been increasingly used as an outcome measure in     interventional studies. Additionally, associations between social support and QoL have been     observed, indicating that improved social support could improve HRQoL, morbidity and     mortality in ESRD patients. However, it is not clear if hemodialysis (HD) and peritoneal     dialysis (PD) have different impacts on HRQoL. Furthermore, comparisons of HRQoL and social     support between HD and PD patients in the multiethnic society of Singapore have not been     evaluated. As such, the investigators propose to conduct this cross-sectional study in the     investigators local multiethnic ESRD patient population to evaluate and compare     patient-reported outcomes (HRQoL and social support), economic and clinical laboratory     outcomes in HD and PD patients.      All chronic HD and PD patients seen in NUH outpatient renal or PD clinic will be included in     this cross-sectional, observational study. Information on patient demographics,     medical/medication histories, dialysis vintage, clinical laboratory data and associated     medical costs will be obtained from clinic notes, electronic medical records and hospital     databases. Patient-reported outcomes will be determined from scores of the Kidney Disease     Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social     Support Scale, Multidimensional Scale of Perceived Social Support, Kessler Psychological     Distress Scale and Health Services Utilization questionnaires (for indirect costs), and     compared between HD and PD patients.      Results from this study will provide important HRQoL information to assist renal physicians     and patients to make treatment decisions. Furthermore, intervention programs could be     developed to improve social support based on patients' needs. These could in turn improve     patients' HRQoL, morbidity and mortality outcomes with minimal risks involved.   "
129700|NCT01587430|"     The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone     consolidation followed by maintenance in the setting of high total cumulative anthracyclines     dose(720-660 mg/m2).   "
129701|NCT01587417|"     To investigate safety, tolerability, pharmacokinetics including dose proportionality, and     pharmacodynamics of BI 187004 CL within a predefined dose range   "
129702|NCT01587404|"     Until recently, there was no way of telling how firmly the tip of the catheter was in contact     with the heart and how this contact was orientated. The electrical signals measured through     the catheters, known as electrograms, are used to guide the sites and duration of ablation,     but the effect of catheter contact and orientation on these signals in human heart muscle     that is fibrillating is not known. New catheters have now been developed which can measure     the force of contact at their tip: using these, the investigators will examine how contact     force affects the electrical behaviour of heart muscle tissue in atrial fibrillation. The     effect the force of contact has on the electrogram recorded will also be investigated. In so     doing we hope to gain a better understanding of the relationship between tissue contact and     the electrograms we measure and in so doing improve the safety and effectiveness of ablation     procedures.      Hypothesis: Catheter contact force and orientation have a significant impact on the     characteristics of bipolar electrograms in the fibrillating human atrium.   "
129703|NCT01587391|"     To investigate safety, tolerability, pharmacokinetics including dose proportionality, and     pharmacodynamics of BI 163538 XX within a predefined dose range   "
129704|NCT01587378|"     The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late     miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester     of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting.      The investigators hypothesis is that metformin compared to placebo treatment from the first     trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and     preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003     consensus criteria, with singleton pregnancy.   "
129705|NCT01587365|"     To obtain safety and tolerability information in healthy subjects is administered as a single     dose   "
129706|NCT01587352|"     This phase II trial studies how well vorinostat works in treating patients with melanoma of     the eye that has spread to other parts of the body. Vorinostat may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
129755|NCT01586715|"     The purpose of this study is to evaluate the practicability of the autologous e-ASC     (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant     perianal fistulae.   "
129707|NCT01587339|"     There are a number of anti-epileptic drugs available for the treatment of partial onset     seizures in patients with epilepsy. This study is a systematic review of the published     literature on anti-epileptic drugs and is designed to compare the relative effectiveness and     tolerability of a selection of them with retigabine. The drugs chosen for this comparison     were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were chosen     because they belong to the newer generation of drugs for epilepsy (as does retigabine) and     they have a similar license as well as having published data from studies that were conducted     in similar patient populations with similar methods. GSK commissioned YHEC (York Health     Economic Consortium) to carry out this review and analysis. YHEC identified relevant studies     from international databases. These studies had compared one of the chosen anti-epileptic     drugs with placebo. The results were pooled and combined in order to summarize the data for     individual drugs as well to compare the results for different drugs with each other and with     retigabine. Since none of the individual clinical studies compared one active drug with     another, this systematic review is an indirect comparison of these drugs, using an     established and recognised methodology which has well understood limitations.   "
129710|NCT01587300|"     Medical scientists want to find better ways to treat neuroblastoma and to find ways to     prevent the tumor from growing back. To do this, they need more information about the     characteristics of neuroblastoma cells. Therefore, they want to study samples of     neuroblastoma tissues and neuroblastoma and normal cells in the blood and bone marrow that     may be related to the growth of neuroblastoma cells. Doctors and other medical scientists     also want to find better ways to detect and measure neuroblastoma to improve the ability to     follow the response of tumor cells to therapy.   "
129711|NCT01587287|"     To comprehensively assess the precision and agreement of anterior corneal power measurements     using 8 different devices.   "
129712|NCT01587274|"     Low back pain causes 2.4% of visits to US emergency departments (ED) resulting in 2.7 million     visits annually. In a general low back pain (LBP) population, prognosis is poor. About 50% of     patients who visited general practitioners with new onset musculoskeletal LBP report     persistent pain and functional disability three months after the index visit. Outcomes are     similarly poor for the population of patients forced to use an ED for management of their     LBP. In an observational study of patients with non-traumatic LBP recently completed at the     PI's institution, patients were contacted one week after ED discharge: 70% reported     persistent back-pain related functional impairment, 59% reported moderate or severe LBP, and     69% reported analgesic use within the previous 24 hours. Three months after the ED visit, 48%     reported functional impairment, 42% reported moderate or severe pain, and 46% reported     analgesic use within the previous 24 hours.      A variety of evidence-based medications are available to treat LBP. Non-steroidal     anti-inflammatory drugs (NSAID) are more efficacious than placebo with regard to pain relief,     global improvement, and requirement of analgesic medication. Skeletal muscle-relaxants too     are effective for short-term pain relief and global efficacy. Opioids are commonly used for     moderate or severe acute LBP,(9) though high-quality evidence supporting this practice is     lacking.      Treatment of LBP with multiple concurrent medications is common in the ED setting. Emergency     physicians often prescribe NSAIDs, skeletal muscle relaxants, and opioids in combination.     Several clinical trials have compared combination therapy with NSAIDS+ skeletal muscle     relaxants to monotherapy with just one of these agents. These trials have reported     heterogeneous results. The combination of opioids + NSAIDS has not been evaluated     experimentally in patients with acute LBP.      Given the poor pain and functional outcomes that persist beyond an ED visit for     musculoskeletal LBP, the investigators propose a clinical trial to evaluate whether combining     muscle relaxants or opioids with NSAIDs is more effective than NSAID monotherapy for the     treatment of non-traumatic, non-radicular low back pain. Specifically, the investigators will     evaluate three distinct hypotheses:        1. The combination of naproxen + cyclobenzaprine will provide greater relief of LBP than          naproxen alone seven days after an ED visit, as measured by the Roland Morris low back          pain functional disability scale        2. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of          LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris          low back pain functional disability scale        3. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of          LBP than naproxen + cyclobenzaprine seven days after an ED visit, as measured by the          Roland Morris low back pain functional disability scale   "
129713|NCT01587261|"     Animal and human data have supported the notion that administration of large doses of Vitamin     C has beneficial effects on those subjects suffering from large burns. This effect may be     due, in part, to the antioxidant and free-radical-scavenging properties of Vitamin C. These     studies have demonstrated an improvement in urine output during resuscitation and reduced     need for fluid volumes during resuscitation. In turn, these subjects demonstrated a reduction     of wound edema, improved respiratory status (demonstrated by improvements in P:F ratios and     reduced ventilator days), and no differences in terms of the possible complications of     high-dose vitamin C administration between standard and treatment groups. The purpose of this     study is to prospectively determine if Vitamin C can be safely used as an adjunctive     treatment for patients suffering severe thermal injuries. High-dose vitamin C administered at     a dose of 66mg/kg/hr during the acute phase of severe burn injuries will reduce fluid     requirements in the first 48 hours after injury.   "
129714|NCT01587248|"     To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL),     operating time, drain Volume and drain Days, seroma formation, surgical site infection and     postoperative pain in adult females undergoing MRM at a tertiary care hospital. We     hypothesized that harmonic yields better outcome than electrocautery dissection.   "
129715|NCT01587235|"     This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current     standard treatment with other statins for the treatment of dyslipidemia in moderate,     moderately-high and high-risk participants.   "
129716|NCT01587222|"     The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin     during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and     followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks     after the beginning of the treatment by isotopic evidence and biochemist determinations. Also     it will be evaluated arterial pressure and determination of vasoactive hormones (plasma     renin, aldosterone and norepinephrine).   "
129717|NCT01587209|"     The investigators hypothesize that membrane microparticles (MPs) are liberated into the blood     stream in response to decompression stress and that certain MPs characteristics initiate     inflammatory responses that contribute to the clinical syndrome the investigators call     decompression sickness. The research goal is to evaluate the number, type and time-course for     elevations in MPs in sport SCUBA divers who present for treatment of decompression sickness.     Blood samples are to be taken from consenting patients before and after they undergo     treatment for decompression sickness and at a follow-up clinic visit from 1 to 3 weeks later     (three samples total).   "
129719|NCT01587183|"     This study will test strategies to help people with prehypertension adopt a running program     to reduce their blood pressure in the long term. This study will be a 12 week intervention of     about 40 participants randomized to running educational material, group based running     instruction, or group based running instruction focused on form and all given the option to     use the supplemental mHealth intervention. The purpose of this study is to collect     feasibility, acceptability and preliminary efficacy data in preparation for a larger planned     NIH-R01 study.   "
129732|NCT01587014|"     The purpose of this study is to test the safety and feasibility of the Prima-Temp Thermometer     Patch in determining baseline temperatures of research subjects in a hospital intensive care     unit (ICU).      Primary Objective: Assess safety of the Prima-Temp temperature patch with nursing staff skin     site assessments.      Secondary Objective: Establish individual subject baseline temperature using intermittent     temperature measurements (every 5 minutes) with the Prima-Temp thermometer patch and wireless     transmission of the data to a receiver box and HIPAA compliant, centrally located personal     computer (PC) and compare research subject's baseline temperature with temperatures taken in     the ICU in the normal course of care.   "
129733|NCT01587001|"     This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC),     on inflammation and oxidative stress in sarcoidosis.   "
129734|NCT01586988|"     The IMAGE intervention was developed to improve parenting and self-care skills in mothers     infected with HIV. It is expected that an improvement in these areas will in turn improve the     mother's physical and mental health as well as the child's mental health and behavioral     adjustment.   "
129720|NCT01587170|"     After spinal cord injury, patients develop a spastic syndrome that is characterized by     hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The     neuronal mechanisms behind the development of spasticity remain largely unknown, though     animal experiments have shown that changes occur both at the level of the motoneuron and     sensory neurons. This project aims to examine the changes that occur in the modulation of     sensory afferent transmission after spinal cord injury, and how these changes can contribute     to the triggering and initiation of muscle spasms after chronic spinal cord injury in humans.      It is known that after spinal cord injury, the majority of descending sources of monoamines,     such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on     sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a     result, after spinal cord injury these receptors are no longer activated below an injury,     resulting in the production of large, long excitatory responses in the motoneuron when     sensory are activated. This large sensory activation of the motoneuron can, in turn, activate     a long response in the motoneuron to produce an involuntary muscle spasm. The aim of our     study is to determine whether, similar to animal experiments, the 5HT1 receptors are     responsible for sensory inhibition in spinal cord injured subjects, and whether activating     these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition of     sensory transmission that is lost after injury, thereby resulting in a decrease in the     initiation of involuntary muscle spasms.   "
129721|NCT01587157|"     Capnography provides noninvasive monitoring of ventilation and can allow early recognition of     altered respiration patterns and apnea. The aim of this prospective study was to compare the     detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography     versus clinical surveillance during procedural sedation for percutaneous transhepatic     cholangiodrainage (PTCD).   "
129722|NCT01587144|"     The purpose of the study is to determine the effectiveness of an investigational drug called     lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of     Glioblastoma Multiforme (GBM).   "
129723|NCT01587131|"     The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will     be safe and generally well tolerated in healthy elderly adult volunteers and will result in     greater immunogenicity when used to prime the immune response to a dose of a trivalent     inactivated seasonal vaccine.   "
129724|NCT01587118|"     This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic     Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of     standard antidepressant treatment.   "
129725|NCT01587105|"     Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington     State Department of Social and Health Services developed the Comprehensive Case Management     (CCM) program with the goal to reduce costs of care for medically complex children cared for     at SCH as well as improve their health status and the quality of care they receive. The CCM     program aims to develop and facilitate a reliable and standardized process that empowers the     child's primary care provider and provides him/her with the resources s/he needs to avoid     unnecessary emergency department visits and admissions. Our study will include children who     had a hospitalization or emergency department visit at Seattle Children's between 2009-2012     and, at that time, had multiple active chronic medical issues but had no specialty service at     Seattle Children's to help their primary care providers manage them.   "
129726|NCT01587092|"     This is a pilot study to assess the feasibility of using treadmill desks (Workstations)     within a Louisiana office workplace and to determine the effects of walking while working in     overweight or obese, sedentary individuals.   "
129727|NCT01587079|"     The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol     Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate     to severe COPD   "
129728|NCT01587066|"     Quetiapine is one of atypical antipsychotics with good efficacy and better side effect     profiles than conventional antipsychotics, so it is being widely used beyond the treatment of     schizophrenia. Recently, the BOLDER I and II study showed that quetiapine monotherapy is an     effective and well-tolerated treatment for depressive episodes in bipolar disorder. However,     most c1inicians did not have confidence with quetiapine monotherapy yet, and most practice     guidelines recommend the monotherapy with mood stabilizer as the first-line treatment. The     Korean medication algorithm for bipolar disorder published in 2006 also recommend the     monotherapy with lithium, divalproex, or lamotrigine in the treatment of mild to moderate     depressive episode of bipolar disorder.      Therefore, the aim of this study is investigating the efficacy and safety of quetiapine     monotherapy when compared with mood stabilizer monotherapy. In addition, the investigators     are going to reveal the quality of sleep and quality of life, of the two groups of patients.   "
129729|NCT01587053|"     The purpose of this study is to measure the INR (International Normalized Ratio) time     percentage in the target zone (TTR: time in therapeutic range) of children benefiting from     the AVK therapeutic education program.   "
129730|NCT01587040|"     Primary Objective:      The purpose of this study is to determine the long term safety and tolerability of SAR245408     and SAR245409 as a monotherapy or as part of a combination regimen in subjects who are     benefiting from treatment.   "
129731|NCT01587027|"     This safety study is the first in a series of studies testing the application of the     combination of aminophylline and methazolamide.   "
129756|NCT01586702|"     Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial     infarction. Poor adherence to evidence based secondary prevention regimens is frequently     seen. Support programs for patients may not only improve adherence to recommended therapies     but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize     that compared to regular care, a structured and patient centered secondary prevention program     will lead to a relative risk reduction of at least 28% of recurrent vascular events.   "
129735|NCT01586975|"     The purpose of this study is to determine if PFA results correlate with ischemic event     outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more     efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.   "
129898|NCT01584804|"     This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough     variant asthma.      The investigators hypothesize:      Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang     antitussive capsule.   "
129736|NCT01586962|"     This is an open label, in-use study to assess the warming sensation, acceptability and local     tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in     subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to     evaluate the acceptability concerning a warming sensation effect and its potential benefit in     the target population.      The primary objective is to assess the warming sensation caused by the excipient IFF flavor     316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup.     The syrup contains (0.15% w/v) warming flavor.      The Secondary Objectives are to assess subject acceptability of the syrup and the safety and     tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from     symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal     congestion associated with colds and flu symptoms such as pain, headache and/or fever.     Subjects must have one or more symptoms per category:        1. mild to moderate body pain, headache, fever or sore throat        2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing          Adolescents will be included in the study population   "
129737|NCT01586949|"     The purpose of this study is to determine whether the intervention Daily Challenge (MeYou     Health, LLC), a behavioral intervention delivered online, is effective in improving     individuals' well-being.   "
129738|NCT01586936|"     This study is conducted in Japan. The aim of this registry study is to observe the use of     single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term     outcomes, including effectiveness, safety, quality of life and treatment satisfaction with     the approved treatments.   "
129739|NCT01586923|"     The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage     RBCs for the time required to clear elevated blood lactate levels in children with severe     anemia.   "
129740|NCT01586910|"     The purpose of the study is to investigate the safety and efficacy of transcatheter aortic     valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at     intermediate surgical risk by randomizing patients to either Surgical Aortic Valve     Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.      Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of     transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic Aortic     Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the     pivotal clinical trial.   "
129741|NCT01586897|"     This project tests a model of chronic disease medication management in which the decision to     initiate or adjust medical therapy is directly linked to a sequence of subsequent clinical     actions (e.g. monitoring for adverse drug events, assessing response to therapy, changing     medication dose) performed independently of the office visit. The investigators hypothesize     that establishing a visit-independent, health information technology (IT) supported cycle of     laboratory monitoring and iterative medication dose adjustment will result in more effective     chronic disease care.   "
129742|NCT01586884|"     It is hypothesized that it is both safe and feasible to use an interventional approach to LV     lead placement (placing the LV lead guided by acute hemodynamic measurements), and that the     LV lead can be placed in a position that is superior to the initial empiric lateral wall LV     lead location in less than 30 minutes without significant risk to patients. The time from RV     capture to LV activation correlates with the optimal pacing site based on stroke volume &     dP/dt measurements.   "
129743|NCT01586871|"     Mucopolysaccharidosis (MPS) syndromes are disorders characterized by enzyme deficiencies, and     they have been linked to heart health complications. However, there are currently no proven     markers of heart and artery health for this population. The main purpose of this     observational study is to evaluate the ease and convenience of a non-invasive measurement of     artery function in MPS I, MPS II and MPS VI patients compared to healthy control subjects. An     observational study is a research design meaning that there is no treatment in this study.      The research questions are:        1. Is the artery health of MPS I, II and VI patients different than healthy controls?        2. Is the artery health of MPS VI patients different than MPS I and II patients?      It is hypothesized that MPS patients will have poorer outcomes of artery health compared to     healthy controls.   "
129744|NCT01586858|"     Rituximab is the first drug approved by the United States Food and Drug Administration (FDA)     for the treatment of patients with granulomatosis with polyangiitis (Wegener's     granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the     long-term safety and efficacy of this drug is not yet clear. This study proposes to follow     patients who were enrolled in the RAVE study to determine if treatment with rituximab     influences long-term outcomes.   "
129745|NCT01586845|"     The purpose of this study is to demonstrate the efficacy and safety of voclosporin     administered orally twice daily for the prevention of acute allograft rejection in recipients     of a kidney transplant.   "
131039|NCT01569815|"     The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and     its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety     of LCZ696 in this population.   "
129746|NCT01586832|"     Stocking of essential supplies in an emergency department (ED) is crucial in order to     efficiently and effectively take care of patients. When equipment and supplies are not     available to patient care providers, an imbalance in the delivery of care is created. The     amount of time nurses spend away from the bedside obtaining supplies has only been     superficially studied; however, one study proposed that the majority of nurses spend 5 to 20     percent or more of their time during a shift. This results in 30 minutes to two-and-a-half     hours of a twelve hour shift being lost to retrieving supplies that are not available.      Cabinets and drawers have recently been eliminated in the rooms and stock is kept in supply     towers that contain all the necessary supplies to adequately take care of patients with the     exception of medications, or stationary supplies. Towers are restocked every morning by a     stocking technician by taking the towers to the stock room, resupplying them based on     previously established PAR levels, and utilizing a standard chart that describes exactly what     supply, and how many to stock within a specified area of the cart.      During their shift, the stocking technician must also respond to pages concerning low stock     levels.      Hypothesis:      Nurses spend a significant amount of time away from the patient bedside during their shift     looking for supplies.   "
129747|NCT01586819|"     This study is being done to find out if the use of botulinum toxin prior to a medium strength     combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will     improve the appearance of crow's feet wrinkles when compared to a chemical peel alone.     Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular     nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and     lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two     products/procedures have been FDA approved to improve the appearance of facial wrinkles.   "
129748|NCT01586806|"     For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative     period can be a painful experience without adequate pain management. Hence the investigators     propose a randomized controlled clinical study, investigating prolonged saphenous nerve     blocks. Patients will be randomized to receive saphenous nerve blocks with or without     dexamethasone, a corticosteroid used to prolong analgesia.      Depending on the randomized treatment assignment, patients may receive one of the following:        1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);        2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;        3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.      Patients will be followed postoperatively. Following admission to the recovery room, data     collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data     collectors will also record patient satisfaction, pain medication use and any side effects     experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days     1, 2 and 14 and asked questions about their general well-being.   "
129749|NCT01586793|"     The aim of this randomized, single-blind trial is to evaluate the effectiveness and     tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation     (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive     either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high)     frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right     dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several     psychometric instruments at baseline, and at weeks 5 and 9.   "
129750|NCT01586780|"     The purpose of the study was to investigate the efficacy of intake of whey or soy protein     isolates, respectively, with or without supplementation of amino acids, on post-meal insulin     secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut     hormones and ghrelin in plasma, as well as subjective satiety was investigated.   "
129751|NCT01586767|"     The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy     (IMRT) or proton radiation therapy would result in improved local control rate and lowered     toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result     in equivalent or improved local control rate with similar or lower toxicity compared to IMRT,     in the treatment of locally advanced sinonasal malignancy.      Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in     promising outcome in patients with sinonasal malignancy. To this date, no prospective study     has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton     radiation therapy. This Phase II trial is the first prospective study conducted to determine     the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer.      IMRT and proton radiation therapy are the two most established and most commonly employed     advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly     controversial whether one is superior to the other in terms of local control and toxicity     outcome. It is also not clear if a subset of patients would benefit more from one treatment     technology versus the other.      Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam     is only available at a few centers in the United States, it is not feasible at present to do     a Phase III study randomizing patients between IMRT and proton radiation therapy. In this     study, a planned secondary analysis will be performed, comparing the treatment and toxicity     outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial     will be used to design future multi-center prospective trials and to determine if randomized     trial is necessary.      In this study, the treatment technique employed for an individual case will not be determined     by the treating physician(s), but rather by the most advanced technology available at the     treating institution for the treatment of the sinonasal cancer. At the Massachusetts General     Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility     criteria. For institutions where protons are not available or institutions where the proton     planning systems have not been optimized, IMRT exclusively will be used for the treatment of     sinonasal cancer. Patient and tumor characteristics are expected to be comparable between     IMRT- and proton- institutions   "
129752|NCT01586754|"     Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction     and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic     and randomized clinical trials. Carotis intima-media thickness is also found to be elevated     in early stages of atherosclerosis. Recent studies have shown correlations between     homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but     no data exists for obese or overweight patients who also have metabolic syndrome, in terms of     markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular     disease and since it is known that patients with metabolic syndrome are at higher risk of     cardiovascular events, the investigators wanted to examine whether there is an association     between homocysteine, microalbumin levels and carotid intima-media thickness in patients with     or without metabolic syndrome, who are either overweight or obese.   "
129753|NCT01586741|"     This is a three armed prospective randomized trial that will compare two different surgical     techniques for reconstruction of the abdominal wall diastasis with a conservative treatment     procedure.      The study hypothesis:      Which surgical approach provides the safest and best long term results for patients with     abdominal wall diastasis either the insertion of net alternative with a double row suture or     exercise alone?   "
129754|NCT01586728|"     This is an open, multicenter, prospective, randomised and cross over study, comparing in     patients with cystic fibrosis aged > 6 years, 2 periods of 6 weeks of oxygen therapy or room     air, separated by a wash out period of 2 to 6 weeks.   "
129757|NCT01586689|"     This study is examining the relative effects of alternative aftercare models for ex-offenders     who are recovering from substance abuse/addiction. The study is a longitudinal, randomized     field trial that assigns participants to one of three conditions: Oxford House, a     professionally-run residential treatment facility, or a control condition that involves usual     aftercare chosen by participants (which may include no treatment at all). Oxford Houses are     self-run residential recovery homes based on the premise of mutual support. These homes do     not involve professional treatment staff and the expenses (e.g. rent, utilities) are paid for     by the residents. The hypothesis of this study is that Oxford House participants will have as     good or better outcomes in terms of substance recovery, recidivism, and health in comparison     to the participants who were assigned to the residential treatment facility, and better     outcomes in comparison to the control group. In addition, the cost to government/tax payers     will be substantially lower given that participants pay their own way.   "
129831|NCT01585701|"     The purpose of this first clinical study of the noval multiple AGC kinase inhibitor, AT13148,     is to identify the recommended dose for future studies in cancer patients by exploring the     safety and maximum tolerated dose and biological effects in patients with advanced solid     tumours.   "
129758|NCT01586676|"     The virtual requirement that substance abuse programs use evidence-based treatments (EBT) has     prompted the development of dissemination strategies to promote EBT technology transfer.     Implementation research, clinical trial training methods, and clinician training studies     suggest that clinical supervision that involves direct observation, fidelity rating-based     feedback, and coaching of therapeutic skills is a promising dissemination approach. However,     clinical supervision delivered within substance abuse programs by on-site supervisors has     never been directly tested in a randomized controlled trial to determine the impact of     supervision on both clinician EBT skills and client treatment outcomes.      Recent results from two NIDA CTN protocols testing the effectiveness of Motivational     Interviewing (MI) have shown that community program clinicians can learn to deliver MI with     fidelity when receiving MI supervision from their program supervisors after workshop training     and that their implementation of MI early in treatment improves client retention and primary     substance use outcomes. A MI supervision manual called MIA: STEP (Motivational Interviewing     Assessment: Supervisory Tools for Enhancing Proficiency) was developed from these protocols     and has begun to be widely distributed by NIDA in partnership with SAMHSA for community     program use. The effectiveness of the MIA: STEP supervision approach is unknown.      This study will directly test the effectiveness of MIA: STEP supervision on clinician MI     fidelity and on client outcomes by randomly assigning 60 clinicians and 420 substance-using     outpatients from 11 community programs within Connecticut to one of two conditions in which     clinicians in both conditions will deliver a 1-session MI intervention to clients as the     enter treatment. The conditions are: 1) workshop training plus MIA: STEP supervision, and 2)     workshop training alone with supervision-as-usual practices used at each program. This     project will be the first randomized trial to examine the impact of clinical supervision in     an empirically based treatment on both clinician and client outcomes. Moreover, because it     will provide workshop training and supervision completely within the context of community     programs and utilize in-house program supervisors, it will provide a rigorous evaluation of a     feasible model for disseminating EBTs such as MI.   "
129759|NCT01586663|"     This is a randomized controlled trial with blinded evaluator and follow-up of one year.     Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The     patients can not change their medication during the study. Patients will be evaluated at     baseline and at 3, 6, 9 and 12 months. The experimental group will use a serial night time     position splint who will be adjusted monthly, while the control group will remain the drug     treatment. The outcomes assessed will be: pain, hand range of motion, quality of life,     functional capacity, upper limb function and dexterity. Our hypothesis is that the serial     night time position splint will improve the hand range of motion in diffuse systemic     sclerosis patients.   "
129760|NCT01586650|"     This is a randomized controlled trial with blinded assessor on the effects of aerobic     exercise (walking)in patients with Ankylosing Spondylitis.   "
129761|NCT01586637|"     Effectiveness of an art therapy program for the treatment of pain and improvements in both     quality of life and body image of patients with fibromyalgia.   "
129762|NCT01586624|"     The purpose of this study is to determine whether using two drugs together called vandetanib     and selumetinib is effective in the treatment of cancer. The first part of this study will     include patients with any solid tumour and the second part of this study will include only     patients with non small cell lung cancer. The four main aims of this clinical study are to     find out:        -  If the two drugs can be given safely to patients when given together.        -  The maximum dose that can be given safely to patients.        -  More about the potential side effects of the drugs and how they can be managed.        -  What happens to vandetanib and selumetinib inside the body.   "
129763|NCT01586611|"     Chemotherapy is often used to help shrink the cancer temporarily and may improve survival for     patients with incurable pancreas cancer that has spread to other organs. In Canada, the     gemcitabine chemotherapy is used to treat pancreas cancer that has spread. The combination of     oxaliplatin with other chemotherapies, including 5-fluorouracil, leucovorin, and irinotecan     has also been studied and has benefit for patients with advanced pancreas cancer. To date,     there is no test that can be done on a patient's tumour to tell if chemotherapy will work in     pancreatic cancer. Human equilibrative nucleoside transporter 1 (hENT1) has been shown to be     a possible predictor that gemcitabine may or may not work but this needs to be proven in a     randomized study where patients get treated with gemcitabine or a different kind of     chemotherapy while their tumours get tested for hENT1.      This study is being done because we want to prove that hENT1 can predict if gemcitabine will     work in advanced pancreas cancer and if it can, we also would like to show that a different     chemotherapy combination called FOLFOX (a combination of 5-fluorouracil, leucovorin, and     oxaliplatin) will be helpful for patients whose tumours don't have hENT1.   "
129764|NCT01586598|"     The purpose of this study is to determine whether sensory retraining exercise could improve     lip numbness caused by bilateral sagittal split of mandible.   "
129765|NCT01586585|"     The investigators will monitor cardiac patients rehabilitation post op upon their pre op     status.   "
129766|NCT01586572|"     Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases     continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in     tribal areas present special challenges in interrupting transmission rapidly. There exists     limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity     levels in young children. The aim of this study is to demonstrate the non-inferiority of     shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary     interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals     beginning at 6 weeks of age.   "
129767|NCT01586559|"     A comparative prospective study assessing the outcomes of recti muscle diastasis correction     with absorbable suture.   "
129791|NCT01586247|"     Healthy older volunteers will be recruited to a study where they will be given four different     treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a     synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be     collected and analysed for changes in faecal microbial populations and selected immune     responses.   "
129777|NCT01586429|"     Post-operative pain following total knee replacement can be disabling and sometimes lead to     the need for prolonged hospital stay. Therefore development of improved post-operative     modalities for total knee replacement surgery pain control is important. High-resolution     ultrasound (US) allows accurate visualization of nerves and surrounding structures and can     lead to higher success rates of nerve block. The investigators aim at comparing the analgesic     efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia for     patients with knee OA who underwent unilateral total knee replacement.   "
129778|NCT01586416|"     The purpose of this study is to develop and pilot test a behavioral intervention for elderly     adults in treatment for colon cancer, to enhance their skills for managing the challenges of     completing chemotherapy regimens. The investigators will assess feasibility and acceptability     of the intervention, and explore preliminary efficacy of the intervention for reducing     psychological distress and improving rates of optimal chemotherapy adherence.   "
129768|NCT01586546|"     Aim: To answer the questions of whether a Mind-Body Medicine (MBM) skills group facilitated     face-to-face and online can improve measures of Quality of Life (QOL) in a population of     cancer patients.      Value of Study: Technological advances have contributed to new venues for healthcare     delivery. It is imperative that these new delivery methods, for individual and/or group     psychosocial services are sufficiently tested and validated. Research shows that there is     very little knowledge about differences in communication styles between online and     face-to-face groups, nor is there much knowledge on the overall efficacy of online groups.      Phenomenon Studied: Can MBM skills groups improve the quality of life of cancer patients? Is     there a difference in outcome between a MBM skills group delivered face-to-face and a MBM     skills group delivered online.      Reasons Leading to Proposing the Project: Despite encouraging research showing that     psychosocial interventions have positive effects in the lives of cancer patients, more     research is needed due to several problems of current research, such as poor study design,     lack of use of technological advances and relatively few existing studies on the     effectiveness of MBM therapies in the oncological setting.      Stated Hypothesis:      Hypothesis 1:      There is no difference between baseline QOL measures and QOL measures at the end of     face-to-face facilitated MBM skills groups.      Hypothesis 2:      There is no difference between baseline QOL measures and QOL measures at the end of Online     facilitated MBM skills groups.      Hypothesis 3:      Participation in either, online facilitated MBM skills groups or face-to-face facilitated MBM     skills groups will improve QOL measures when compared to control group.      Hypothesis 4:      Patients in the control group (waitlist control, care as usual group) will have no     improvement on QOL measures.      Anticipated Value to the Larger Community: According to the National Center for Complementary     and Alternative Medicine (NCCAM) …there is a need for reliable, objective, evidence-based     information regarding the usefulness and safety—or lack thereof—of CAM (National Center for     Complementary and Alternative Medicine, 2011, p.3). This study will add to general scientific     knowledge of CAM and MBM.   "
129769|NCT01586533|"     This double-blind, randomized, comparator-controlled Phase II study is designed to establish     the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with     left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease     activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects     will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or     comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally     into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the     trial will be enrolled concurrently in a randomized fashion.   "
129770|NCT01586520|"     Thyroid cancer is a relatively rare disease but its incidence is increasing in many     countries.. Early and accurate diagnosis leading to earlier treatment and intervention is     recognised as a major factor in determining a good outcomes. This study will investigate new     ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The     study will take samples from patients with differentiated thyroid cancer and measure relative     quantities of 1000s of proteins within the blood. These measures will be explored to see if,     when used in combination they can accurately diagnose thyroid cancer. If successful this     technique could be extended to routine screening and could replace more invasive tests     currently used. Participants will be required to supply a small sample of blood, answer     questions on their medical history and also consent for their medical records to be examined.     A lifestyle questionnaire will also be supplied to each participant. In the case where a     diagnosis is predicted for a condition the participant was not aware of the medical team will     discuss the best interests of the patient with their GP and if required refer them to a     suitable specialist. The study will run for 24 months and will routinely process around 15     and 20 participants with a history of thyroid cancer per month. All patient details will be     kept confidential and only non identifiable information will leave the clinic. The work will     be published and if successful will be validated on another site, commercialised and made     available for routine clinical use.   "
129771|NCT01586507|"     The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of     ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years old,     inclusive (up to 17 years 364 days) with pain due to injury or nonmalignant disease, to the     PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic     tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and     how it is removed from the body over time.   "
129772|NCT01586494|"     The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of     ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old,     inclusive (up to 11 years 364 days) with pain due to injury or nonmalignant disease, to the     PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic     tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and     how it is removed from the body over time.   "
129773|NCT01586481|"     It's a pilot prospective opened multicentric randomised study. We measure the efficiency and     the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK)     to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic     patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis     or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with     BAROUK shoe   "
129774|NCT01586468|"     Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects     with persistent allergic rhinitis.      Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre     trial.      Subjects 50 subjects (25 per treatment group) with history of persistent allergic rhinitis     for at least 2 years prior to enrolment and a positive allergen skin test. Subjects will be     required to have a minimum mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS)     (mean score of morning and evening reflective TNSS assessments for the 3 days prior to     randomization and treatment.      Treatments At the first treatment visit (T1), subjects that comply with the inclusion and     exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo.      Each individual treatment dose of study drug solution is 0.5 mL/kg body weight, diluted into     500 mL saline solution. Treatment will be administered once daily for 5 consecutive days     (Visits T1-T5) via intravenous infusion.   "
129775|NCT01586455|"     The purpose of this clinical trial is to investigate the safety of human placental-derived     stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in     patients with various malignant or nonmalignant disorders who require a stem cell transplant.     Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and     immunotherapy followed by a stem cell transplantation with UCB and HPDSC.   "
129776|NCT01586442|"     In this proposal,the investigators will examine whether the selectivity of eplerenone for the     MR will translate into a better glucose and metabolic profile compare to spironolactone in     patients with HF with glucose intolerance or type 2 diabetes. In addition, the investigators     will also compare the impact of these two agents on changes of concentrations of established     prognostic biomarkers of neurohormonal activation and extracellular matrix turnover.   "
129781|NCT01586377|"     Recent clinical investigations have suggested that the cause of abnormal pain in complex     regional pain syndrome could be ischemia and inflammation, due to poor blood flow to deep     tissues from microvascular pathology. This study aims to determine if a new technology called     near infrared spectroscopy can measure this microvascular dysfunction. The study hypothesizes     that significant differences can be measured in the microcirculation of patients with CRPS-I     using near infrared spectroscopy and the vascular occlusion test.   "
129782|NCT01586364|"     The objective of the study was to assess the long-term safety of daily doses of ospemifene 60     mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a     uterus.   "
129783|NCT01586351|"     The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix     from Arthrex is possible with the arthroscopic technique.   "
129784|NCT01586338|"     Primary Objective:        -  To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index          (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score        -  To evaluate the safety using the incidence, severity, seriousness, relatedness, and          frequency of all treatment emergent Adverse Events (AEs)      Secondary Objectives:        -  To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8,          and 12        -  To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26        -  To evaluate the change in Patient Global Assessment (PTGA) score between baseline and          weeks 8, 12 and 26        -  To evaluate the change in Clinical Observer Global Assessment (COGA) score between          baseline and weeks 8, 12 and 26        -  To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and          between baseline and weeks 1, 2, 8, 12 and 26   "
129785|NCT01586325|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a     drug is absorbed and distributed in the body), and intrinsic antiviral activity of     JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus     (HCV)-genotype-1-infected patients at different doses and dose regimens.   "
129786|NCT01586312|"     In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC),     obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial     is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We     propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and     controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay     consists of two arms with 15 patients each one. Patients in the experimental arm will be     given an intra-articular transplantation of allogenic MSC, expanded Ex Vivo with our     GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as     in NCT01183728). In the control arm a standard treatment with intra-articular injection of     hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of     life and quantitative changes in structure and composition of cartilage determined by     T2-weighted MRI relaxation (Cartigram) for one year.   "
129787|NCT01586299|"     The purpose of this study is to evaluate the influence of routine NSAIDs treatment for     hospitalized children with pleuropneumonia in comparison with acetominophen treatment (all in     conjunction with adequate antibiotic therapy).   "
129788|NCT01586286|"     The objective of this study is to perform a randomized controlled trial among female patients     with a diagnosis of pelvic floor hypertonus (extreme muscle tension) with associated pain,     dysfunctional voiding, dyspareunia, and/ or obstructed defecation.   "
129789|NCT01586273|"     The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic     Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating     painful bone metastases.   "
129790|NCT01586260|"     The purpose of this research study is to evaluate a new investigational drug to prevent     reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The     objectives of this study will be to monitor for safety and look at efficacy of DFMO.      The safety of the proposed dosing regimen in this trial will be tested by an on-going     risk/benefit assessment during the study. A patient benefiting from treatment, not     progressing on therapy, and in the absence of any safety issues associated with DFMO may     continue on treatment up to 27 cycles with the expectation that there will be an overall     clinical benefit.      The procedures involved in this study include Medical history, Physical exam, Vital signs     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the     tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are     considered standard of care for this population. Drug administration is also part of this     protocol, including an investigational new drug called DFMO.      The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day     while on study. There will be 27 cycles. Each cycle will be 28 days in length.   "
129796|NCT01586182|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational intervention (in this case, the stereotactic radiation boost). Phase I     studies also try to define the appropriate dose of the investigational intervention to use     for further studies. Investigational means that the stereotactic radiation treatment is     still being studied and that research doctors are trying to find out more about it. It also     means that the FDA has not approved a stereotactic radiation boost for your type of cancer.      In this research study, the investigators are looking for the highest dose of the     stereotactic radiation boost that can be given safely. Because the stereotactic radiation     boost is so precise, the investigators are testing whether it can be used to increase the     dose to the primary tumor without significantly increasing the side effects you experience;     the goal is to improve the likelihood of successfully treating the tumor.   "
129797|NCT01586169|"     The purpose of this study is to determine whether the triple co administration of     albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that     consists to treat with albendazole plus ivermectin together and a week later to treat with     azithromycin in areas co endemic for lymphatic filariasis and trachoma.   "
129832|NCT01585688|"     The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to     determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated     dosing schedule). The secondary objectives are to obtain information on efficacy,     pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for     subsequent studies.   "
129798|NCT01586156|"     Pulmonary arterial hypertension (PAH) is a serious condition characterized by endothelial     dysfunction leading to pulmonary vascular constriction, smooth muscle and endothelial     proliferation, and progressive right-sided heart failure. The severity of pulmonary     hypertension is mostly determined by the response of the right ventricle (RV) to the     increased afterload or pulmonary pressures, and RV failure is the leading cause of death in     PAH. Most accepted therapies for PAH have been aimed at vasodilation of the pulmonary     vasculature, and there has been little thought that PAH patients would benefit from     traditional left heart failure treatments. A cornerstone therapy in left heart failure is     £]-adrenergic receptor blockade because of its ability to reverse cardiac remodeling and     improve clinical outcomes, despite decades of concern regarding its propensity to exacerbate     heart failure. It has been reported to reduce mortality by about 30% in patients, and while     the precise mechanisms that contribute to its beneficial effects remain to be elucidated,     there is evidence that patients with underlying contractile reserve (i.e., via recruitment of     viable myocardium with £]-adrenergic receptor stimulation) may experience greater recovery of     their cardiac function. In a study using rats with pulmonary hypertension treated with £]     blocker, RV function improved, and maladaptive myocardial remodeling was prevented.   "
129799|NCT01586143|"     This is a clinical study that aims to investigate and compare the efficacy of transbuccal     paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with     acute pain of moderate intensity accepted to emergency room following a minor trauma of the     lower limbs and/or superiors. To this end, several pain scoring will be performed using a     visual analogue scale (VAS) at various times after drug administration.   "
129800|NCT01586130|"     Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs,     especially the quadriceps; leading to disease progression. Advantages of muscular strength     training for the treatment of this kind of O.A. is now well established. In this therapeutic     field, isokinetic exercises seem to have a better efficiency than other, more frequently     used, kinds of exercises such as isometric or isotonic exercises.      Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces     muscles to work in eccentric mode.      The hypothesis of this study is that muscular strengthening using isokinetic exercises in     eccentric mode would have a more important benefit than isokinetic exercises in concentric     mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative     knee exercises in the treatment of knee O.A.   "
129801|NCT01586117|"     The purpose of this study is to evaluate the effect of intrarectal Amifostine administration     on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.   "
129802|NCT01586104|"     This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating     younger patients with lung metastases. Specialized radiation therapy that delivers a high     dose of radiation directly to the tumor may kill more tumor cells and cause less damage to     normal tissue.   "
129803|NCT01586091|"     Primary objective:      The comparative efficacy of levocetirizine 5 mg once daily with that of fexofenadine 60 mg     twice daily against histamine induced wheal, flare and itch responses measured at 0     (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours.      Secondary objectives:        1. The areas under the curves (0 , 12 hours, 12 - 24 hours and 0 - 24 hours) for inhibition          of histamine induced wheal, flare and itch responses for levocetirizine 5 mg once daily          and fexofenadine 60 mg twice daily.        2. The number of individuals with peak responses in each 10 percentile (Because of the          variable absorption of fexofenadine, it is predicted that fexofenadine will have a          variable response between individuals).        3. The mean plasma levels of levocetirizine and fexofenadine at 0 (baseline), 0.5, 1, 2, 3,          4, 6, 8, 10, 12 and 24 hours.   "
129804|NCT01586065|"     The purpose of this study is to see if children and adolescents with poorly controlled type 1     diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be     used to check blood sugars.   "
129805|NCT01586052|"     This purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin     for children with cerebral palsy.   "
129829|NCT01585740|"     The objective of this study is to compare the effect on mean maternal and neonatal pH, and     24-hour postoperative morbidity, following intraoperative infusion of Ringer's Lactated     versus normal saline in caesarean section at Mulago Hospital.      The null hypothesis is that intraoperative infusion of Ringer's Lactate in caesarean section     at Mulago Hospital will not result in 30% less mean maternal and neonatal pH change than     intraoperative infusion of normal saline.   "
130084|NCT01582321|"     Inflammation is a key initiating and damaging factor in many illnesses including infection,     arthritis and cancer but also of particular relevance to this study in diseases of the heart     and blood vessels (i.e. cardiovascular disease). Much evidence now exists demonstrating that     male sex increases ones risk of cardiovascular disease. More recent evidence demonstrates     that inflammatory responses in females appear to dampened in comparison to age matched males.     Since inflammation is thought to be a key initiating phenomenon in many cardiovascular     disease states the investigators will examine the differences in acute inflammatory responses     between the sexes in healthy volunteers and the impact this has on the function of blood     vessels.   "
129830|NCT01585727|"     One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is     the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for     diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying     degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal     cancer despite potentially nerve-sparing total mesorectal excision (TME).      The study will examine the impact of a newly developed continuous monitoring device for     preservation of urogenital function in patients with TME for rectal cancer. 188 patients will     be included in the prospective, randomized, single-blind, parallel group multi-centre trial     including two arms (TME with and without intraoperative continuous monitoring of pelvic     autonomic nerves). The primary efficacy endpoint is the change in urinary function measured     by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions     measured as secondary endpoints. The application of the continuous intraoperative     neuromonitoring device could enhance the objective intraoperative confirmation of pelvic     nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes     the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An     enormous reduction of treatment costs is to be expected.   "
129806|NCT01586039|"     The timing and quality of sleep is governed by environmental and physiologic factors.     Environmental factors, especially ambient lighting can impact the circadian system and alter     the timing and structure of sleep. Light exposure can also acutely alter neural activation     state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength     blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue     light in the evening persist for at least 3-4 hours after the lights are turned off, and can     disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep     on subsequent sleep would be beneficial to sleep quality and potentially health.      The investigators will compare the effects of two light sources, equated for visual stimulus     (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux     exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white     light source that is depleted in the short-wavelength visible range (Biological Illumination     LCC, FL). In a within-subject design, the investigators will test the hypotheses that     exposure as compared to a CFL 90 lux exposure 90 lux of the blue-depleted LED will cause     significantly:        1. Less melatonin suppression between melatonin onset and bedtime;        2. Less subjective and objective alerting responses before bedtime;        3. Less disruption of nocturnal sleep structure and quality.   "
129807|NCT01586026|"     This study is to compare the rate of adverse events in subjects with maintenance flushes     greater than 28 days.   "
129808|NCT01586013|"     This study obtains an effect site model for White (Modified Marsh) pharmacokinetic propofol     model. The plasma effect-site rate constant (ke0) obtained is affected by age.   "
129809|NCT01586000|"     This clinical trial is an experimental research study using a potential new form of birth     control. Clinical trials include people who volunteer to take part in a study. Take your time     to decide if you want to be part of this experimental research study. If you want to know     more about this study first, ask the study doctor or study site staff. The investigators can     also give you the study information written for doctors and clinic staff.   "
129810|NCT01585987|"     The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as     sequential or maintenance treatment immediately after first-line chemotherapy in the     treatment of unresectable or metastatic gastric and gastro-esophageal cancer.   "
129811|NCT01585974|"     This study is a prospective, non-interventional, non-controlled, multi-center, observational     cohort study. The medication is prescribed within the regular practice of the physician.     Duration and dosage of treatment is solely at the discretion of the attending physician. The     primary objective of this study is to assess duration of treatment in Turkish renal cell     carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate     prior cytokine treatment within the first month of treatment.   "
129812|NCT01585961|"     This is a prospective, interventional, observational, unblinded, single-arm, multicenter     registry of younger and older subjects with drug refractory, recurrent, symptomatic     paroxysmal atrial fibrillation.   "
129813|NCT01585948|"     In the present study the investigators will measure the extent of coronary artery disease via     coronary angiography and the correlating risk factors.   "
129814|NCT01585935|"     Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot     immediately be nourished with mother´s or formula milk and are typically dependent on     parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver     complications of PN, namely parenteral nutrition associated cholestasis (PNAC).      Intravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision of     energy and essential fatty acids in preterm infants. However, they might be implicated in the     pathogenesis of PNAC.      ILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion     containing 15 % fish oil together with soy bean, olive and MCT oil has become available in     Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the     standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore     ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there     are no data so far.      The study aims to evaluate the fish oil containing ILE SMOFlipid® for its protective effect     against PNAC in ELBW infants compared to standard treatment with the soy bean based ILE     Intralipid®. Furthermore neurodevelopment at 12 and 24 months of corrected gestational age     will be investigated.   "
129815|NCT01585922|"     In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on     decreasing inflammatory response, improving the pathophysiological manifestation and reducing     the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS)     patients, the investigators conduct this clinical trial comparing NPPV with invasive     mechanical ventilation in more than twenty ICUs in China.   "
129816|NCT01585909|"     The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in     preventing invasion of gastrointestinal bacteria.   "
129817|NCT01585896|"     The proposed study aims to investigate the efficacy of a facilitated self-help group for the     treatment of hoarding disorder. Eligible participants will take part in a facilitated     self-help group. The investigators aim to investigate the effects of a self-help group on     hoarding symptoms. The investigators hypothesize that participants will demonstrate decreased     hoarding symptoms over time.   "
129818|NCT01585883|"     The purpose of this study is to investigate the suitability and practicality of a coaching     and support intervention in helping patients to use daily strategies for managing     breathlessness. Also, the investigators will try to understand how useful it is in helping     patients to reduce intensity of breathlessness and its impact their quality of life.   "
129845|NCT01585519|"     This study will examine if health benefits of consuming nutrient-rich apples, an apple     extract and freeze dried apple product will be similar. 50 volunteers at increased risk of     heart disease will consume either a low apple diet (<1 portion/d), 2 high or low polyphenol     apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten     participants per group, randomly assigned). Apart from the extract group, all volunteers will     consume a placebo. All volunteers will follow a low apple diet (<1 apple per day) other than     what has been provided by the research team. Volunteers will complete food diaries at the     start and end of the study and a number of questionnaires. Blood and urine samples collected     at 0 and 4 weeks   "
129819|NCT01585870|"     This Phase 1 study will be conducted in an open-label, non-randomized, dose-escalation design     in subjects with advanced, metastatic or refractory solid malignancy who are not candidates     for standard therapy. The study drugs are sorafenib and eribulin mesylate.      Up to 24 subjects with solid tumors will participate in the dose escalation part of the     study, and once the maximum tolerated dose is defined, up to 30 subjects with advanced,     metastatic or refractory solid tumors will participate in the expansion phase of the study.      Eribulin (mesylate) will be administered intravenously at a fixed dose of 1.4 mg/m2 on Days 1     and 8 of 21-day Cycles.      The starting sorafenib dose (Dose Level 1) is 200 mg twice daily. Sorafenib is given orally,     continuously on days 11 to 21 of Cycle 1, and from Day 1 to Day 21 of all subsequent cycles.     If 200 mg sorafenib twice daily is tolerated with eribulin, the sorafenib dose will be     escalated sequentially to 200 mg morning dose and 400 mg evening dose (Dose Level 2) in a new     cohort. If Dose Level 2 is tolerated, a second dose escalation to 400 mg twice daily (Dose     Level 3) will be studied in a new cohort. If the starting dose of sorafenib is not tolerated     with eribulin, the sorafenib dose will be de-escalated to 200 mg once daily in a new cohort.     Subjects will need to receive two cycles of eribulin plus sorafenib therapy and safety data     for the first and second cycle needs to be available before the start of the next cohort.   "
129820|NCT01585857|"     Primary:      To study the safety of a single injection of autologous adipose derived mesenchymal stromal     cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).      Secondary:      To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal     cells on patients with moderate or severe osteoarthritis of the knee (OA).   "
129821|NCT01585844|"     Obstructive sleep apnea is known to be a significant source of morbidity in the general     population. It has been proposed to be associated with the development of preeclampsia and     fetal growth restriction. As these are conditions that have long term maternal and neonatal     implications, further information may help improve maternal/fetal outcome. One reason why     women and in particular pregnant women are under diagnosed is the lack of an effective,     reliable screening tool. Validated questionnaires used in the general population may not be     effective in screening pregnant women. The investigators hypothesize that sleep apnea will     have 20% prevalence in the obese pregnant population and that it is associated with increased     maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their     prenatal care clinics and they will be screened for OSA using validated sleep questionnaires     including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The     subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea     detection device. Women who meet clinical criteria for OSA will be referred for overnight     polysomnogram and management by the Pulmonary and Critical Care Division of the Internal     Medicine Department. For all enrolled patients the remainder of prenatal care will be per     routine. Data will be collected regarding the pregnancy course and outcomes.      The primary outcome of interest is the prevalence of sleep apnea in obese women and the     associated maternal and neonatal morbidity. The secondary outcome measures will be molecular     measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep     apnea.   "
129822|NCT01585831|"     The purpose of this study is to determine if testosterone replacement therapy leads to     changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also     called Klinefelter syndrome). This study will also evaluate whether certain genetic factors     of the X chromosome affect the psychological or motor features of XXY/Klinefelter syndrome.   "
129823|NCT01585818|"     Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally     accepted as the cornerstone for the treatment of people with type 2 diabetes mellitus (T2DM).     Consumption of low glycaemic index (GI) meals have been shown to improve glycaemic control,     lipid profile and reduced systemic inflammation. However, these studies and international     evidence-based nutritional recommendations are principally based on people of European     ethnicity consuming fairly typical western diets. There are few published controlled     dietary intervention studies which have attempted to determine appropriate dietary patterns     for the treatment of diabetes amongst populations consuming rice-based diets.      HYPOTHESIS        1. The glycaemic response over 6 days as measured by CGMS will have a lower mean glucose          level and postprandial increase in individuals consuming the LGI compared with the SDI          meal plan.        2. A LGI meal plan is acceptable and participants will adhere and comply to the diet to the          same level as those receiving the SDI meal plan.        3. Glycaemic and metabolic parameters as measured by integrated area under the curve (IAUC)          of glucose and insulin are lower after a single meal comprising of LGI than compared          with an SDI meal.        4. The effect of a single meal of LGI reduces appetite and increases satiety compared with          a meal of SDI.   "
129824|NCT01585805|"     This randomized phase II trial studies how well veliparib together with gemcitabine     hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone     in treating patients with pancreatic cancer that has spread from where it started to nearby     tissue or lymph nodes (locally advanced) or spread from the primary site (place where it     started) to other places in the body (metastatic). Veliparib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,     such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. It is not yet known whether giving veliparib together with gemcitabine     hydrochloride and cisplatin is an effective treatment for pancreatic cancer.   "
129825|NCT01585792|"     The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in     diabetic patients.   "
129826|NCT01585779|"     The purpose of this study is to gather clinical information on the hemodynamic performance of     the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.   "
129827|NCT01585766|"     The purpose of this study is to evaluate the safety and tolerability of ascending intravenous     (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of     multiple sclerosis (MS).   "
129828|NCT01585753|"     This is a substudy of MARCH, in which we are exploring the changes in the vascular     endothelium using pulse wave tonometry (a non invasive measure of cardiac health) to measure     the changes in small and large arterial elasticity in participants of the MARCH study who     switch to maraviroc-based regimens over 96 weeks of follow-up.   "
129834|NCT01585662|"     EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to     place several stents to drain the content of cyst into GI tract. In the investigators     experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than     placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified     naso-pancreatic tube drainage method were found recurrent with a follow up period from 3     months-34 months. So, the investigators designed this prospective random comparing study to     confirm the result.   "
129835|NCT01585649|"     This is a Phase I, open label study aimed at assessing the pharmacokinetics,     pharmacodynamics, the efficacy, safety, and tolerability of a single injection of XM22 in     children with Ewing family of tumors or rhabdomyosarcoma scheduled to receive chemotherapy     (CTX)   "
129836|NCT01585636|"     This is a phase 1, first in man study to evaluate single oral doses (5-300 mg) of SQ109, a     new investigational drug being developed for treatment of tuberculosis. If single doses are     safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy     volunteers and patients with pulmonary tuberculosis.   "
129837|NCT01585623|"     Primary Objective:        -  To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome          P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).        -  To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.      Secondary Objectives:        -  To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in          Segment 1        -  To characterize the safety and tolerability of 28-day consecutive doses of 500 mg          SAR302503 in Segment 2        -  To determine antitumor activity in Segment 2   "
129838|NCT01585610|"     The purpose of this study is to determine if a newly designed DVD program performs better     than standard, printed quit-smoking materials to help smokers who have mobility limitations     (e.g., use a cane, wheelchair, braces, crutches, prosthesis) to quit smoking.   "
129839|NCT01585597|"     The purpose of this study is to determine whether reducing a patients body temperature (mild     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury     (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a     significant interruption of blood flow to an area of brain (occlusion of large proximal     cerebral artery) and have undergone successful removal of that interruption     (revascularization).   "
129840|NCT01585584|"     The purpose of this study is to test the potential antiviral efficacy of triple-combination     therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype     3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).   "
129841|NCT01585571|"     The results of this study will have an impact upon public heath policy as adults with     cerebral palsy (CP) present a growing and underserved population in the United States. At the     conclusion of this study, we will have identified the means by which the adult with CP     maintains their upright position, which is essential for activities of daily living and for     movement. With this knowledge, it will be possible to develop clinical and rehabilitation     interventions that will improve their arm and leg function, and reduce the risk of falls for     the adult with CP.   "
129842|NCT01585558|"     The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily     doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal     women with an intact uterus.   "
129843|NCT01585545|"     The purpose of this study is to evaluate relationships between multiparametric imaging     biomarkers and genetic analysis in NSCLC patients.   "
129844|NCT01585532|"     Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis     specific nucleic acid in urine and blood of patients.   "
129846|NCT01585506|"     This study is conducted in Europe. The aim of this study is to investigate psychosocial     factors related to compliance with treatment with biphasic insulin analogues.   "
130222|NCT01580514|"     Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has     significant cardiovascular protective effects in various conditions. The investigators     examined whether conventional use of exenatide at the time of primary percutaneous coronary     intervention would reduce the infarct size in patients with ST-segment elevation myocardial     infarction (STEMI).   "
129847|NCT01585493|"     Schizophrenia is a life shortening disease, not only because of suicide but also because of     increased mortality from natural causes. Recently, a large register-based study, involving     complete national data from Denmark, Sweden and Finland, showed that life expectancy for     schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the     general population, and that mortality from medical conditions and diseases are responsible     for a large proportion of the reduced life expectancy. Patients with schizophrenia had a     twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases,     lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated     physical disorders play an important role in this excess mortality.Results from the Danish     National Indicator Project for Schizophrenia showed that a much higher proportion of patients     with schizophrenia compared to the general population have measures of waist circumference,     body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper     values.      In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two     different interventions both aiming to reduce risk for death from medical diseases. We will     compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to     connect the patient to general practice and primary care and 3) affiliation to a staff member     from the CHANGE team who should facilitate life style changes and contact with general     practice. The objective is to identify interventions that can reduce the risk of early death     in patients with schizophrenia.   "
129848|NCT01585480|"     The purpose of this research study is to develop, implement, and evaluate a multi-component     obesity prevention program in a workplace setting. A quasi-experimental design will be     utilized, with hospital employees receiving the intervention and clinic employees serving as     the comparison group. It is hypothesized that the intervention group will see greater changes     in healthier eating, increased participation in physical activity, and reduced risk for     obesity (weight, BMI, waist circumference).   "
129849|NCT01585467|"     To compare and validate the two clinical algorithms   "
129850|NCT01585454|"     Background:      - Women can gain too much weight or develop diabetes during pregnancy. If the mother is     overweight or has diabetes during pregnancy, her baby may also be at risk of being overweight     or developing diabetes. A woman s chance of getting diabetes increases if her parents or     family members are overweight or have diabetes. Poor diet and exercise habits can also lead     to weight gain and diabetes. Researchers want to study how best to improve the health of     pregnant women and their children. They will do so by providing healthy lifestyle counseling     for women receiving prenatal care at the Phoenix Indian Medical Center.      Objectives:      - To study the effectiveness of healthy lifestyle counseling for overweight and/or diabetic     pregnant women.      Eligibility:        -  Women at least 18 years of age who will receive pregnancy care at the Phoenix Indian          Medical Center.        -  Participants must be overweight or obese. They may or may not have diabetes.      Design:        -  Participants will receive standard prenatal care from the midwives, doctors, and          dietitians at the Phoenix Indian Medical Center.        -  Participants will work with National Institutes of Health staff for about 2 hours every          week. These sessions may include phone calls, home visits, or group meetings.        -  Participants will have a total of nine measurement visits. The first visit will be at or          before 16 weeks of pregnancy. The next three visits will be within a week of the first          visit. Another four visits will take place between 23 and 28 weeks of pregnancy.        -  Participants will have different tests through their pregnancy. They will wear heart          monitors and wrist monitors to measure heart rate and movement. They will provide          information on their eating habits, physical activity, and mood and feelings during          pregnancy. Blood samples will be collected to measure blood glucose (sugar) levels.        -  Participants will receive counseling on healthy eating and physical activity habits.          They will be encouraged to invite friends or family members to learn more about healthy          lifestyle choices.        -  The study will end with the final visit about 6 to 8 weeks after giving birth. A final          blood sample will be collected. Participants will be asked questions about mood and          feelings.   "
129851|NCT01585441|"     Background:        -  Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under          the retina. It affects the macula, which is in the center of the retina and is needed          for sharp, clear vision. In many cases, CSC resolves on its own and does not need          treatment. However, in some cases it does not go away or comes back after treatment.          This is known as chronic CSC.        -  Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can          alter the effects certain of androgens. Researchers want to compare finasteride with a          placebo to see if it is a safe and effective treatment for chronic CSC.      Objectives:      - To see if finasteride is a safe and effective treatment for chronic CSC.      Eligibility:      - Individuals at least 18 years of age who have chronic CSC in one or both eyes.      Design:        -  Participants will be screened with a physical exam and medical history. A full eye exam          will be performed. Blood and urine samples will also be collected.        -  Some participants may have photodynamic therapy (PDT), the standard treatment for CSC.          PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for 3          months after PDT before starting the finasteride study.        -  Participants will be separated into two groups. One group will take finasteride 5 mg          (formulated into capsules); the other group will take a placebo capsule. All          participants will take the capsules for 3 months.        -  After 3 months on the assigned capsule (finasteride or placebo), all participants will          have the opportunity to take finasteride for at least another 4 years and 9 months. This          phase of the study is optional.        -  Participants will have regular study visits. At each visit, they will have physical          exams and eye exams. They will also provide blood and urine samples.        -  During the first 3 months, participants will have 2 study visits. After 3 months, if the          participant continues in the optional (or as needed) phase of the protocol, visits will          occur at Month 6, Month 12 and every 12 months thereafter. However, additional visits          may be needed.   "
129852|NCT01585428|"     Background:      The human papillomavirus (HPV) can cause a number of cancers, including cervical and throat     cancers. The National Cancer Institute (NCI) Surgery Branch has developed an experimental     therapy that involves taking white blood cells from patients' tumors, growing them in the     laboratory in large numbers, and then giving the cells back to the patient. These cells are     called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to     over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people     with human papilloma virus (HPV)-related cancer. In this study, we are selecting a specific     subset of white blood cells from the tumor that we think are the most effective in fighting     tumors and will use only these cells in making the tumor fighting cells.      Objective:      The purpose of this study is to see if these specifically selected tumor fighting cells can     cause HPV-related cancers to shrink and to see if this treatment is safe.      Eligibility:      - Adults age 18-66 with HPV-related cancer who have a tumor that can be safely removed.      Design:      Work up stage: Patients will be seen as an outpatient at the National Institutes of Health     (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab     tests, and other tests as needed.      Surgery: If the patients meet all of the requirements for the study they will undergo surgery     to remove a tumor that can be used to grow the TIL product.      Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells.     {Leukapheresis is a common procedure, which removes only the white blood cells from the     patient.}      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the     conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for     about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.   "
129888|NCT01584934|"     Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical     and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS     patients, however, the relationship between (disturbed) sleep quality and fatigue is still     not fully elucidated. To evaluate the effect of sodium oxybate on fatigue and to explore the     interdependence of sleep quality and fatigue in CFS, a double blind, randomized, placebo     controlled cross-over trial with sodium oxybate is carried out in CFS patients.      The aim of this study is to address the issue of the effect of sodium oxybate on fatigue as a     presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying     medical or psychiatric illness. The answer to this question may shed further light on the     enigmatic relationship between sleep and fatigue. We also want to investigate the effect of     sodium oxybate on sleepiness and general health in the same target population.      Zero-hypothesis: there is no effect.   "
129853|NCT01585415|"     Background:      - One possible treatment for advanced melanoma involves collecting white blood cells from the     person with cancer and growing them in a laboratory. The cells can then be given back to the     donor. This study will use this white blood cell treatment with the cancer treatment drug     vemurafenib. Vemurafenib targets melanoma cells that have a mutation in the B-raf gene, and     may be able to make them shrink.      Objectives:      - To see if vemurafenib and white blood cell therapy is a safe and effective treatment for     advanced melanoma.      Eligibility:      - Individuals at least 18 years and less than or equal to 66 years of age who have advanced     melanoma that contains the B-raf genetic mutation.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  White blood cells will be collected from tumor cells. These cells will be collected          during surgery or a tumor biopsy.        -  Participants will have leukapheresis to collect additional white blood cells for the          procedure.        -  Participants will take vemurafenib twice a day, starting 3 weeks before receiving the          white blood cells.        -  Participants will have 1 week of chemotherapy to prepare their immune system to accept          the white blood cells.        -  Participants will receive an infusion of their collected white blood cells. They will          also receive aldesleukin for up to 5 days to boost the immune system s response to the          white blood cells. They will remain in the hospital until they have recovered from the          treatment.        -  Participants will have frequent follow-up visits to monitor the outcome of the          treatment.   "
129866|NCT01585233|"     The purpose of this study is to explore the safety and tolerability of multiple doses of     ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects     with moderate to severe psoriasis.   "
129899|NCT01584791|"     The aim of the current study is to compare the antiplatelet efficacy and safety of     clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients     after coronary stent implantation.   "
129854|NCT01585402|"     Background:        -  Arterial Calcifications due to Deficiency in CD73 (ACDC) is a rare genetic disease.          People with ACDC develop calcium deposits in the arteries and joints of the fingers,          wrists, ankles and feet. These deposits cause severe pain in the hands and feet, even          when the person is at rest, and may lead to loss of the affected hand or foot.          Currently, there are no standard treatments for ACDC.        -  Etidronate is a drug that helps to slow or stop the natural process that dissolves bone          tissue. It is approved to treat Paget s disease, a condition in which the bones are soft          and weak and may be deformed, painful, or easily broken. It is also used to treat high          blood calcium levels. Researchers want to see if it can be used to treat the symptoms of          ACDC and improve pain and blood flow in the hands and feet.      Objectives:      - To see if etridronate is a safe and effective treatment for ACDC.      Eligibility:      - People between 18 and 80 years of age who have been diagnosed with ACDC.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have imaging studies, including x-rays and DEXA bone scans, before starting treatment.          Blood and urine samples will be collected. An exercise tolerance test will also be          given.        -  Participants will take etridronate by mouth once a day for 14 days every 3 months. They          will be assigned an individualized 6-month drug schedule to follow. Participants should          not eat foods that are high in calcium for at least 2 hours after taking the study drug.        -  Participants will have regular study visits throughout the treatment period. These          visits will involve imaging studies, full dental exams, and blood and urine tests.          Participants will also have exercise tolerance tests and arm and leg blood pressure          tests to measure pain and blood flow.        -  Participants may also provide tissue samples for further study.        -  Treatment will continue for up to 3 years as long as the side effects are not severe and          the condition does not become worse. Participants will have a final follow-up visit          after stopping treatment.   "
129855|NCT01585389|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to brain tumors.      PURPOSE: This research studies gene expression and location in samples from patients with     brain tumors.   "
129856|NCT01585376|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and find biomarkers related to     cancer. It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial studies genes in samples from younger patients with     rhabdomyosarcoma.   "
129857|NCT01585350|"     The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1)     combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and     Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to     test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at     whether the experimental vaccine and these drugs cause any changes to the immune system.   "
129858|NCT01585337|"     The hypotheses of this study are as follows:        1. There is no significant muscle activity difference of each muscle in patients between          pre and post operation.        2. There is no significant forward reach distance/average velocity difference in patients          between pre and post operation.        3. There is no significant standard deviation of center of pressure (COP) along x axis,          speed of COP along y axis during the task and COP path during the 3-sec holding phase          difference in patients between pre and post operation.        4. There is no significant muscle activity difference between muscles on both sides at post          operation.   "
129859|NCT01585324|"     This open-label, multicenter, phase IV study will evaluate the relationship between the drop     in hemoglobin levels and sustained virological response in patients with chronic hepatitis C     genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients     will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously     weekly. Anticipated time on study treatment, depending on virological response, will be 48 or     72 weeks.   "
129860|NCT01585311|"     The purpose of this retrospective study is to test the hypothesis that uncontrolled     tachycardia serves as a risk factor for adverse cardiovascular events and poor outcome after     Subarachnoid Hemorrhage (SAH).   "
129861|NCT01585298|"     Study to evaluate bradycardiac events during first dose observation of fingolimod in MS     patients   "
129862|NCT01585285|"     The purpose of the AMI-PONT trial is to assess whether the results in term of graft patency     with a novel coronary artery bypass (CABG) strategy, including a saphenous vein bridge to     distribute the arterial flow of the left anterior mammary artery (LIMA) to all the     anterolateral territory, are not inferior than a conventional CABG strategy combining     separated LIMA graft to left anterior descending coronary and vein graft for other target     vessels of the anterolateral territory.   "
129909|NCT01584661|"     Objectives:        1. To determine the level of compliance with nutritional recommendations (dietary and          nutritional supplements) following discharge from hospitalization;        2. To identify barriers for post-discharge adherence to professional nutritional          recommendations;        3. To determine the impact of adherence (high vs. low) to the nutritional treatment          guidelines on functional and health indicators.      Working hypothesis:      High adherence to nutritional care after hospitalization will be associated with better     functional and health outcomes.   "
130236|NCT01580319|"     This research project is about a physical activity intervention in pediatric outpatients to     try control and prevent heart diseases such as hypertension, obesity, high cholesterol.   "
129863|NCT01585272|"     This phase IIIb study is intended to implement a consistent treatment way for switching to     Exelon transdermal patch from oral formulation of rivastigmine to stress the importance of     (1) advantages of transdermal patch over conventional oral therapies: smooth drug delivery     with reduced side effects;(2) encourage treatment compliance in the Alzheimer's dementia     setting.      This study is a single-arm, treatment-switched design. Eligible patients, who are under     Exelon capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed     by treatment switch from oral capsule to patch for 48 weeks maintenance treatment. During the     maintenance period, the treatment will be initiated with Exelon Patch 4.6 mg/24 hours (Exelon     Patch 5 cm^2) for the first 24 weeks and the dose will be escalated to Exelon Patch 9.5 mg/24     hours (Exelon Patch 10 cm^2) for another 24 weeks if well tolerated. Visits to assess safety     are scheduled at baseline, 3 days, 1 week and 2 weeks after the first treatment switch, every     4 weeks until Week 40, and at the end of study (Week 52). The assessment to address the     primary objective will focus on the safety of treatment switching (Week 0~28); however the     safety assessment will be performed during the whole study period.   "
129864|NCT01585259|"     Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction     patients   "
129865|NCT01585246|"     The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing     the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms     will be recorded each week, as well as assessment of quality of life through: 1) Physical     Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional Well-Being.   "
129867|NCT01585220|"     This study design is a randomized, multi-center, double Masked, matched Pairs,     active-controlled clinical trial. Subjects who voluntarily signed the informed consent and     are judged to be eligible for this study will be intradermally injected both of study device     and comparator device. Subjects will be randomized to receive injection of study device and     comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in     Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks     follow up visits and subject diary which will be given to subjects during the first 2 weeks     after the injection. Any uncomfortable things and adverse events will be investigated from     subeject diary and follow up visits.   "
129868|NCT01585207|"     The purpose of this study is to determine if vigabatrin, an unusual anti-seizure medication,     will diminish the Tourette Disorder outbursts in young adults whose symptoms have persisted     into adulthood and have not responded to usual treatment.   "
129869|NCT01585194|"     The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to     control uveal melanoma.      Ipilimumab is designed to increase the immune system's ability to fight cancer.      Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the     body's immune system to work against tumor cells.   "
129870|NCT01585181|"     The purpose of this study is to compare the safety and immunogenicity of a single dose of the     PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200,     which is a live attenuated bacteria, can be transmitted to other adults living in the same     household.   "
129871|NCT01585168|"     This project compares Family History Positive (FHP) for alcoholism subjects to matched Family     History Negative (FHN) subjects derived from the project Principal Investigator's National     Institute on Alcohol Abuse and Alcoholism-funded longitudinal study of drinking behavior in a     2000 college freshman population (known as the Brain and Alcohol Research in College Students     study (BARCS)). The age of these subjects is a valuable one at which to capture the     transition from harmful use to abuse/dependence. This project explores the effects of     memantine in a double-blind, randomized, counterbalanced manner on alcoholism risk-relevant     tasks. More specifically, this project studies functional MRI tasks related to different     aspects of reward and/or impulsivity-related behavior in different contexts, compares the     underlying neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic     system to examine NMDA/DA interactions. The combined measures provide the opportunity to     advance our understanding of specific aspects of brain function related to familial     alcoholism vulnerability in an already well-characterized population as some members evolve     into alcohol abuse. In addition to conventional within-task analyses, functional network     connectivity and allied approaches will be used to examine brain networks across tasks.      The investigators will study adult male and female subjects in equal numbers who are either     offspring of an alcoholic parent or are FHN matched controls. The investigators will recruit     and assess a total of 84 (42 FHP and 42 matched FHN) subjects between the ages of 18-21 years     on initial BARCS contact. The investigators will use 4 cognitive tasks during the functional     MRI (fMRI) which include: 1) a Monetary Incentive Delay Task that distinguishes networks     engaged in motivational (anticipation) and consummatory (outcome) components of reward     processing; 2) a Go/No-Go Task that measures the ability to inhibit response to a pre-potent     stimulus; 3) an Alcohol Cue Reactivity Task that examines Nucleus Accumbens response to     alcohol-related versus matched soft drink stimuli; and 4) a Pavlovian-to-Instrumental     Transfer (PIT) Task that dissects a component of the Monetary Incentive Delay (MID) Task, and     provides an imaging assay of a transfer-like process that can be related to real-world     drinking behavior, thus informing upon and extending the key findings from CTNA-2.   "
129872|NCT01585155|"     The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity     index (CAI) score and other evaluation indicators in pediatric patients with moderate to     severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2,     and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also     evaluated.   "
129873|NCT01585142|"     The purpose of this study is to assess the growth of infants fed with BabyNes System,     compared to the World Health Organization Reference, during the first four months of life.   "
129874|NCT01585129|"     To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for     pregnancies with treated chorioamnionitis.   "
129875|NCT01585103|"     Whether the cytosponge will be a useful non-invasive tool in evaluating patients with     eosinophilic esophagitis?   "
129924|NCT01584466|"     Comorbid substance abuse leads to many deleterious effects such as medical comorbidities and     nonadherence, which is one of the most problematic issues. People with schizophrenia and     substance use disorders (SUDs) are at an increased risk nonadherence compared to those who do     not use alcohol and illicit drugs. The investigators propose that this new marketed     injectable antipsychotic with many benefits over other available long acting injectable     agents would be beneficial in the dually diagnosed population and may represent a specific     schizophrenia subpopulation where long acting agents may be considered an important     therapeutic option.   "
129876|NCT01585090|"     Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female     pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial     in different studies. The aim of this study is to assess the effect of ankle positions on     pelvic ﬂoor muscle force during PFM exercises.      This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of     pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad     University of Medical Sciences in 1389. After clinical examination and confirmation of pelvic     floor muscle relaxation, women were randomize divided into 3 groups, doing strengthening     exercises of PFM in standing position with passive ankle dorsi ﬂexion (on wooden surface with     15 degree angle)(n=20), active ankle plantar ﬂexion with arm up (standing on toe)(n=20) and     horizontal standing position (n=19) for 8 weeks. PFM exercises were instructed to women by     using a pamphlet and face to face education. They were followed up every two week by     telephone call and were asked to refer to women's clinic after 4 & 8 weeks. Pelvic floor     muscles strength was assessed with brink score before and after intervention. Data analyzed     by using analytic-descriptive statistics.   "
129877|NCT01585077|"     This study is a randomized clinical trial designed to compare the susceptibility of naive and     pre-immune volunteers to infectious challenge with viable Plasmodium vivax sporozoites. The     term preimmune hereafter denoted only previous experience with infection by this parasite and     not a definite state of immunity to malaria infection. The study hypothesis is that     pre-immune volunteers present a delayed onset of malaria clinical and parasitological     manifestations when compared to naive individuals. The development of this study will     establish a protocol for evaluating the effectiveness of vaccine candidates against P. vivax     in subsequent Phases IIa and IIb clinical trials.   "
129897|NCT01584817|"     Cell phone retell the instruction of bowel preparation on the day before colonoscopy would     help patient to prepare for colonoscopy and improve the quality of the bowel preparation.   "
129878|NCT01585064|"     The purpose of this trial is to assess the effect of two Intensive Outpatient Management     Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid     Arthritis (RA) that are treated with adalimumab.      This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial.     A total of 300 patients (100 per group) with RA will be recruited from approximately 40 sites     across Canada.   "
129879|NCT01585051|"     The effect of administration of vitamin D is tested on the long-term control of blood sugar     (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood     pressure profiles)in patients with stable type 2 diabetes mellitus   "
129880|NCT01585038|"     The purpose of this study is to compare the cardiovascular profiles of efavirenz and     rilpivirine, which are two drugs used to treat HIV infection.   "
129881|NCT01585025|"     The investigators propose to develop studies of obeticholic acid (OCA) in patients with bile     acid diarrhoea. OCA is a semisynthetic bile acid, also known as 6αethylchenodeoxycholic acid     or INT747,and is a potent farnesoid X receptor (FXR) agonist. Preliminary data suggests that     patients with bile acid diarrhoea have impaired production of the ileal hormone Fibroblast     Growth Factor 19 (FGF19). FGF19 is stimulated by FXR agonists, and regulates bile acid     synthesis. This study is a pilot, proof-of-concept, open-label study to investigate whether     OCA can stimulate FGF19 in bile acid diarrhoea patients to provide a safe and effective     treatment.   "
129882|NCT01585012|"     This is a human factors usability study designed to validated usability by obtaining feedback     in a home use environment regarding ease of use of the Focus Touch™ Conception System     Conceptacle (when used to collect semen) and the instructions for use. The investigators will     collect data to demonstrate that the usability requirements of the conception system as     collection device, as determined by Usability Specification: Focus Touch Conception System,     ER-000001 have been met. The ability of the device to be used during sexual intercourse     without discomfort or injury to the female participant's vaginal/cervical tissues shall also     be taken into account. Participating couples will be asked to use the Focus Touch™ Conception     System Conceptacle (in condom form), using the Instructions For Use, to collect semen during     sexual intercourse in a home use environment. This study will involve sexual intercourse     between monogamous, heterosexual couples who are trying to conceive or are on a non-vaginal     birth control with which they do not normally use condoms. Participants will be asked to     complete the study and the questionnaire within 3 days of receiving the study packet. Contact     information shall be collected, but participants will only be contacted if they fail to     return the questionnaire within the requested timeframe.   "
129883|NCT01584999|"     Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three     types of RBCs: 1- fresh standard RBCs (storage <10 days); 2-leukodepleted RBCs and 3-old     standard RBCs (storage >15 days) respectively. Before and 1 hour after the transfusion,     microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed     Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate,     mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.   "
129884|NCT01584986|"     Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an     emerging treatment modality for no-option patients with peripheral artery disease (PAD). The     purpose of this study was to assess safety and efficacy of ex vivo expanded, peripheral     blood-derived, autologous angiogenic cell precursors (ACPs) in no-option PAD patients.   "
129885|NCT01584973|"     Stair negotiation is an important activity of daily living. Patients with cruciate ligament     injury may have difficulty in stair negotiation because of the proprioception deficit and     neuromuscular deficit caused by ligament injury. However, the influence of knee cruciate     ligament injury on the control of movement is still unclear. Since inter-joint coordination     can provide the information of relationship between angle position and angle velocity, it may     be useful to analysis the change of movement pattern.This current study aimed to investigate     the change of inter-joint coordination and muscle activation in patients with cruciate     ligament injury during stair negotiation.   "
129886|NCT01584960|"     The aim of the present study is to investigate the effect of endurance on PSA doubling time     in prostate cancer patients with an elevation in PSA following radical prostatectomy for     localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory     markers and improvement in insulin sensitivity and body composition are investigated.   "
129887|NCT01584947|"     The aim of the project is to do a fase two trial, where the effect of a local anesthetic     lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste as     well as investigate a potential antiinflammatory effect in patients with burning mouth     syndrome, Sjögrens syndrome and lichen planus.   "
129889|NCT01584921|"     Erythropoietin (EPO) is a glycoprotein produced mainly in the kidney. After its release to     the bloodstream EPO binds to its receptor predominantly located within the bone marrow where     erythropoiesis is stimulated. Recently, we have shown that recombinant human EPO (rHuEPO)     down-regulates circulating levels of renin and aldosterone. Concomitant clearance studies     revealed a decrease in proximal tubular reabsorption of sodium and water and a fall in     glomerular filtration rate (GFR). These results for the first time demonstrate a link between     EPO and renal function: By inhibiting proximal tubular reabsorption, which in turn results in     rapid declines in GFR and renin/aldosterone levels, EPO may directly reduce the major oxygen     consuming factor in the kidney. The expected result will be an increase of the oxygen tension     in the environment of renal EPO producing cells, in this way initiating an appropriate signal     for down-regulation of endogenous EPO synthesis when circulating levels of EPO are high.      The aim of this project is to test this hypothesis by investigating the renal effects of     rHuEPO in humans. In a double-blinded manner healthy subjects will be tested with placebo, or     low-dose rHuEPO for two weeks, or high-dose rHuEPO for three days. Accurate sodium balance     studies will be conducted together with renal clearance studies for measurements of renal     plasma flow (131I-Hippuran clearance with renal venous sampling), GFR (51Cr-EDTA clearance)     and the segmentel tubular handling of sodium and water (lithium clearance).      EPO is the sole haematopoietic growth factor that is mainly produced in the kidneys and the     project will provide new information about basic physiological issues regarding the     association between renal function and the regulation of EPO synthesis.   "
129890|NCT01584908|"     Influenza is an important public health problem. Organ transplant patients are particularly     susceptible to severe disease. Also, they shed higher quantities of virus for longer     durations, leading to greater contagious potential, thereby potentially serving as nodes of     spread in the community. Therefore, improved strategies to prevent influenza in this     population is an important public health concern. Standard vaccination is poorly immunogenic     post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules     that create a strong local inflammatory response and they attract immune cells to the site of     injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza     vaccines containing adjuvants have become available in Canada but have only limited     information in transplant patients. This randomized trial is designed to assess the     immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for     seasonal influenza in a cohort of adult organ transplant recipients.   "
129891|NCT01584895|"     Cardiac rehabilitation programs improve mortality, functional capacity, and quality of life,     for a variety of patients with heart disease. It stands to reason that patients with LVADs     might therefore also benefit from the same structured exercise training, education, and     clinical surveillance. One potential benefit of cardiac rehabilitation in this patient     population is reversal of the skeletal muscle atrophy that occurs due to extended periods of     poor peripheral perfusion (i.e. before implantation) and prolonged sedentary behavior.      Purpose: The purpose of this proposed study is to examine the effects of a 6-week exercise     program on cardiorespiratory fitness, quality of life, and device flow rate in patients with     recently implanted LVADs.      Methods: 30 patients with recently implanted LVADs will be referred by the Henry Ford     Hospital Advanced Heart Failure Program once the patient is deemed appropriate for exercise.     Before enrollment into cardiac rehabilitation patients will undergo a six minute walk test     and graded exercise stress test on a treadmill to determine exercise capacity. Additionally,     a quality of life questionnaire will be given.      Following the stress test, patients will be randomized (2 to 1 ratio) into either cardiac     rehabilitation or control. Those chosen to be in the control group will be encouraged to     maintain daily activities; those in the rehabilitation group will partake in 6 weeks of a     standard cardiac rehabilitation program. This will consist of 3 days a week of supervised     exercise as well as education regarding diet and lifestyle modifications.      At 6 weeks after randomization both groups will again undergo fitness assessments and retake     the quality of life questionnaires.   "
129892|NCT01584882|"     Electronic dental records (EDR) are a potentially powerful tool to incorporate current     scientific evidence into clinical practice by providing key information at the point of     patient care. The investigators know that disseminating evidence-based guidelines is not     sufficient to change clinical practice so innovative approaches need to be tested in     dentistry. The composite expertise of the investigators and consultants on this project and a     large group practice with multiple clinics utilizing one EDR are essential to address the     aims of this study. This project will examine whether dentists and hygienists will assess     interest in quitting and deliver a tobacco intervention more frequently when provided with     computer assisted guidance compared to a control group. Specifically the investigators will     measure the delivery of questions assessing willingness to change and appropriate     interventions based on willingness to change by measuring the recording of these activities     in the EDR and patient receipt of these recommendations through a phone survey. In addition,     the study will do a qualitative assessment of the patient perceived value of the     provider-patient encounter to further inform us about patient perception of this interaction.     The investigators want to know if dental providers will utilize these tools during the dental     encounter. If they are used, the investigators would propose further studies examining     smoking cessation rates. The investigators were not able to measure cessation rates due to     the short two year timeline of this funding mechanism. This tool has potential application     for other clinical topics, which makes this approach very innovative when considering the     translation of evidence into the unique clinical practice of dentistry.   "
129893|NCT01584869|"     Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe     GI-Bleeding.   "
129946|NCT01584167|"     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling     associated cerebrovascular disease. The narrow-time-frame is a major issue (time is brain).     To provide immediate cooling without delay, easy to use, mobile and effective methods are     needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Flex.Pads     (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling     system. A comparison of these two induction methods has never been done before. Neither was     the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2     compares feasibility, safety and efficacy of the two methods.   "
129894|NCT01584856|"     It is known that small dense LDL particles are associated with an increased cardiovascular     risk. LDL particles can be separated by gradient gel electrophoresis (GGE) according to their     size. The risk to suffer from coronary heart disease is 3-7 fold elevated in subjects with     small dense LDL particles compared to subjects with large LDL particles. This study aims at     evaluating the predictive value of small dense LDL particles in patients with prediabetes and     type 2 diabetes mellitus concerning future changes in intima media thickness, flow-mediated     dilation and other risk factors of atherosclerosis (e.g. insulin resistance). 60 patients     with prediabetes or type 2 diabetes will be recruited for the study. Assessment will include     medical history (risk factors), physical examination (blood pressure, BMI, waist-to-hip     ratio), collection of serum, oral glucose tolerance test, measurement of intima media     thickness and endothelial dysfunction by ultrasound. All measurements will be repeated after     2 years. Data will be analysed to assess whether the amount of small dense LDL particles can     predict further structural and functional changes of the cardiovascular system or changes in     the severity of the disease (insulin resistance).   "
129895|NCT01584843|"     Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820     compared with non-treatment in patients with strabismus based on angles of strabismus in the     primary position.   "
129896|NCT01584830|"     The purpose of this study is to assess if Regorafenib in combination with best supportive     care will slow down tumor progression and result in increased survival in patients with     metastatic colorectal cancer.   "
129900|NCT01584778|"     Eosinophil cationic protein (ECP) is a matrix protein of eosinophils and has been reported to     reflect eosinophil activity. Few studies have examined the role of eosinophils in the     pathogenesis of Behçet's disease. The purpose of the present study is to investigate the     serum ECP levels in BD and its relation to clinical activity.   "
129901|NCT01584765|"     Drug re-administration or rechallenge should be avoided after drug-induced liver injury     (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug     and patient subjects. In order to better predict these outcomes, the objective of this     analysis is to assess clinical outcomes of positive drug rechallenge following possible     drug-induced liver injury. Electronic medical records from Kaiser Permanente California     (KPSC), a managed care organization, will be utilized to identify patients who experience     possible drug-induced liver injury following exposure to medications associated with     hepatotoxicity, and who are then rechallenged with the medication.   "
129902|NCT01584752|"     This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high     transsphincteric fistulas. Follow-up time is six months   "
129903|NCT01584739|"     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics     of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation     of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given     once daily.   "
129904|NCT01584726|"     The purpose of this study is to investigate the use of magnesium sulfate nebulization in     patient with moderate to severe asthma exacerbation in pediatric emergency.   "
129905|NCT01584713|"     The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the     treatment of enterocutaneous fistula.   "
129906|NCT01584700|"     Heart failure is a common condition with debilitating symptoms and a poor prognosis. Patients     with heart failure have a massively overactive sympathetic nervous system which attempts to     compensate for their poorly functioning heart. This ultimately has only detrimental effects.      One of the principle mediators for this sympathetic response is found in the nerve cells in     the kidneys. Whilst a significant proportion of medications used to treat heart failure act     on these harmful pathways, none target the kidney sympathetic-nerve cells specifically.     Additionally, because of their multiple sites of action these drugs all have side effects.      A new procedure that has recently been developed for the treatment of high blood pressure is     renal denervation. This involves inserting a small catheter through the femoral artery and     passing it to the kidney artery under x-ray guidance. From there, using radiofrequency waves,     the sympathetic nerves within the kidney can be destroyed.      The investigators anticipate that this procedure will have a significant positive effect on     patients with heart failure and aim to perform a pilot safety study on 7 individuals with     advanced heart failure to assess its safety and effectiveness. The investigators hypothesise     that renal artery denervation will lead to significant clinical and biochemical improvements     in patients with marked heart failure.   "
129907|NCT01584687|"     Objectives: 1. Determine if mRNA expression could be use as a biomarker to predict and     monitor the response to omalizumab in patients with difficult control asthma 2. Identify     which genes are switched on and which are switched off by using Omalizumab.      Methods: This study is an open label clinical trial, with six patients. The patients will     receive Omalizumab according to their age and weight (maximum dose: 375 mg every 15 days) for     4 months. There will be a run-in period of one month, when allergic asthma diagnosis will be     confirmed and treatment will be optimized. Patients will be evaluated and will have blood     sample collected on 3 occasions: in the beginning, 2 months after baseline and at the end of     the study. Blood samples will always be collected one week after the last omalizumab dose.     Primary outcome will be RNA expression of 20 genes measured by real time-PCR (high-affinity     IgE receptor, IL-4, IL-5, IL-13, gama-IFN, quimokines, Fc epsilon, between others). Secondary     outcomes will be ACT, ACQ and spirometry.   "
129908|NCT01584674|"     The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic     System in patients with moderate to severe facial acne vulgaris using a split-face design     (treated hemiface vs untreated hemiface).   "
129910|NCT01584648|"     This is a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib     (GSK2118436) and trametinib (GSK1120212) combination therapy to dabrafenib administered with     a trametinib placebo (dabrafenib monotherapy). Subjects with histologically confirmed     cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K     mutation positive will be screened for eligibility. Subjects who have had prior systemic     anti-cancer treatment in the advanced or metastatic setting will not be eligible although     prior systemic treatment in the adjuvant setting will be allowed. Approximately 340 subjects     will be randomized 1:1 (combination therapy: dabrafenib monotherapy). Subjects will be     stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus     less than or equal to the ULN) and BRAF mutation (V600E versus V600K). The primary endpoint     is investigator-assessed, progression-free survival for subjects receiving the combination     therapy compared with those receiving dabrafenib monotherapy. Subjects will be followed for     overall survival; crossover will not be permitted.   "
129911|NCT01584635|"     Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less     invasive treatment for Achalasia has been developed.      The purpose of this study is to decide the role this less invasive treatment (Peroral     Endoscopic Myotomy) has in the treatment of patient's with achalasia.   "
129912|NCT01584622|"     The purpose of the study is to evaluate the effectiveness of the CADence system, a     non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in     the coronary tree.   "
129913|NCT01584609|"     This is a prospective, randomized, single blind, concurrent controlled, multi-center study.     Patients presenting with symptoms of acute ischemic stroke who have evidence of a large     vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned     to either the Penumbra System with the Separator 3D or the Penumbra System without the     Separator 3D. Each treated patient will be followed and assessed for 3 months after     randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute     ischemic stroke in vessels accessible to the Penumbra Separator 3D System for     revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the     safety and effectiveness of the Penumbra System with the Separator 3D for the     revascularization of large vessel occlusion is not inferior to the Penumbra System alone.   "
129914|NCT01584596|"     The Lower Mississippi Delta (LMD) population is characterized by high levels of overweight     and obesity, which are the result of long-term disruptions in energy imbalance where dietary     energy intake has exceeded energy expenditure associated with physical activity. To address     this issue, the overall goal of this project is to determine ways in which the U.S.     Department of Health and Human Services and U.S. Department of Agriculture Dietary Guidelines     for Americans (2005) physical activity recommendations can be effectively adapted for the LMD     population. Phase I of this study was completed in early 2011.   "
129915|NCT01584583|"     The purpose of this study is to monitor the blood pressure level of the patient using a     preformed cuff ranged 22 cm-36 cm.   "
129916|NCT01584570|"     The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation     on heart rate variability and QTc interval.   "
129917|NCT01584557|"     The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in     subjects hospitalized for worsening heart failure who have volume overload and one of the     following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy.     The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8     and 16 hours.   "
129918|NCT01584544|"     This phase I study is designed to determine the maximum tolerant dose of capecitabine when     used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75     years old.   "
129919|NCT01584531|"     The primary objectives of this study are to determine if rigosertib sodium, given orally in     the form of soft gel capsules, is safe and is associated with a reduction in the number of     blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS)     classified as Low or Intermediate-1 (Int-1) (any cytogenetics) or trisomy 8 Intermediate 2     (Int-2) in the International Prognostic Scoring System (IPSS) who are transfusion-dependent.     Rigosertib will be taken on days 1 to 21 of a 21-day cycle.   "
129920|NCT01584518|"     The long-range goal of this proposal is to decrease morbidity and mortality related to     pulmonary edema and congestive heart failure (CHF) in post-operative patients. The     short-range goal is to determine a mechanistic endpoint when therapy for impending heart     failure can be initiated and terminated based on B-type natriuretic peptide (BNP) levels. The     investigators propose to utilize changing levels of BNP as a surrogate marker for CHF.   "
129921|NCT01584505|"     Cardiac Safety Study   "
129922|NCT01584492|"     The purpose of this clinical study is to compare the improvement in breathing of single     administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug     beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with     spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose     100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg)     given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children.      Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to     placebo and the effect on other lung function parameters, to assess the safety and     tolerability of CHF 1535 dosages in children.   "
129923|NCT01584479|"     This study is one component of a program to improve the maintenance of good dental health and     the prevention of disease by use of risk stratification methods to efficiently guide     increased preventive services to adult dental patients who are at increased risk for the     major dental diseases, caries and adult periodontitis.      The investigators will use a retrospective cohort model to analyze a large dental claims     database to determine if the frequency of preventive services influenced the periodontal     disease outcomes and to determine if periodontal risk assessment information can be used to     stratify dental patients into high risk and low risk categories that influence the effect     of preventive services on periodontitis outcomes.      Primary Objective To evaluate whether dental patients who are classified as low risk for     periodontal disease progression, based on history of periodontitis (claims history), smoking,     diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they     had two dental cleanings per year compared to one cleaning per year.      Secondary Objectives To evaluate whether dental patients who are classified as high risk     for periodontal disease progression, based on a history of periodontitis, smoking, diabetes,     and IL-1 genetic variations, have different primary and secondary endpoints if they had two     dental cleanings per year compared to one cleaning per year.      To evaluate whether dental patients who have had one dental cleaning per year have different     primary and secondary endpoints if they are classified as low risk for periodontal disease     compared to patients who are classified as high risk. To evaluate whether dental patients     who have had two dental cleaning per year have different primary and secondary endpoints if     they are classified as low risk for periodontal disease compared to patients who are     classified as high risk.   "
129947|NCT01584154|"     The purpose of this study is to compare the safety and effectiveness of cryoablation and     radiofrequency ablation in the treatment of the commonest kind of supraventricular     tachycardia, namely atrioventricular nodal reentrant tachycardia. The study hypothesis is     that cryoablation is non-inferior to radiofrequency.   "
129925|NCT01584453|"     Despite advances in the treatment of heart attacks the complications and death rates from     failure of the heart to pump properly after treatment remain high. A heart attack occurs when     one or more of the arteries that supply blood to the heart become blocked, causing the heart     to be starved of oxygen and nutrients. This results in damage to the heart and so the the     heart pumps less well. The main treatment for a heart attack is balloon treatment to open the     blocked artery (called primary angioplasty). Whilst re-opening the artery is essential and     allows blood to flow to the area of the heart starved of oxygen, this process also causes     damage itself (called reperfusion injury) and increases the size of the heart attack further.     Currently there are no treatments available that reduce this reperfusion injury. The     investigators and others have shown that a substance called sodium nitrite reduces     reperfusion injury in experimental models of a heart attack. The aim of this research is to     perform a trial to investigate whether during a heart attack, an infusion of sodium nitrite     into the damaged artery protects against reperfusion injury and reduces heart attack size in     patients.   "
129926|NCT01584440|"     The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923     compared to placebo, for the treatment of symptoms of agitation in patients with Alzheimer's     Disease (AD).   "
129927|NCT01584427|"     Background Life style related disease is an increasing problem all over the world. The     Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood     lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high     risk of developing Type 2 Diabetes and cardiovascular disease.      Dietary fibers have been shown to have positive effects on the components of MetS. The     investigators have special interest in the combination of two types of fiber (Resistant (RS)     starch and Arabinoxylans (AX)) .      Hypotheses Increase of RS and AX in the dietary composition has a positive effects on     components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and     markers of inflammation.      The subjects undergo two dietary interventions of 4 weeks duration each: A Healthy     Carbohydrate Diet with a high content of RS and AX is compared to a Western Style Diet     with a low content of RS and AX.   "
129928|NCT01584414|"     Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and     neoplastic cells. Because of the potential importance of such a capability, the investigators     undertook to investigate Zetiq's CellDetect® staining technology as applied to cultured cell     lines as well as an initial sample of clinical cases. This goal was pursued by investigating     four types of comparisons: 1) cancer cell lines before and after differentiation; 2) cervical     squamous-cell carcinoma (SCC) biopsies to non-neoplastic squamous epithelium; 3) SCCs to     neoplastic, nonmalignant squamous epithelium; and 4) neoplastic squamous cells to     non-neoplastic squamous cells in cytological preparations. The clinical material was also     stained with hematoxylin and eosin (biopsies) or Pap (cytologies) for diagnostic purposes.     The investigators found that all CellDetect®-stained cells exhibited one of the two     tinctorial outcomes. Cell lines with malignant phenotype uniformly had red/purple cytoplasm,     whereas the differentiated phenotype changed the color to blue/green.   "
129929|NCT01584401|"     Main study objectives:        1. To compare the temperature measured using Medisim's thermometers to the temperature          measured using mercury or equivalent reference thermometers.        2. To develop more accurate algorithms for measuring on the forehead as well as behind the          ear.        3. To test the difference between various forehead measurement locations in order to allow          more convenient measuring that is not depended on the exact location.   "
129930|NCT01584388|"     The primary objective of this study is to evaluate the safety and effectiveness of rituximab     in IgG4-RD.   "
129931|NCT01584375|"     Intraventricular hemorrhage (IVH) in preterm infants is one of many devastating consequences     of prematurity that have both acute and long-term sequelae. Turning a preterm infant's head     to one side may increase intracranial pressure and occlude major ipsilateral veins in the     neck, which could increase cerebral venous pressure and decrease cerebral venous drainage.     Keeping preterm infants' heads in a slightly elevated midline position (side or supine)     during the first 168 hours(HOL) has been recommended as one of the 10 potentially better     practices to reduce the incidence of IVH in preterm infants. To the best of our knowledge,     there has been no systematically collected clinical data quantifying the relationship between     IVH and head position in preterm infants. However, the midline head position may challenge     the well-known right neonatal head position preference. This preference continues until 3-6     months of age, after which preterm neonates keep their heads mainly in midline. The best head     position for preterm neonates is still to be determined. Therefore, the investigators are     aiming to conduct a large scale multicenter randomized control trial on order to answer the     following research question: Does keeping heads of preterm infants less than 30 weeks of     gestation in flat midline (FM) throughout the first 168 HOL reduce the risk of IVH compared     to right flat lateral (rFL)? We hypothesized that keeping heads of preterm infants less than     30 weeks of gestation in FM throughout the first 168 HOL would reduce the risk of IVH     compared to rFL.   "
129932|NCT01584362|"     This research is being done to learn about the safety in humans of a medicine that is already     used in cows and pigs to treat worms. The medicine may be useful for people who have these or     other worms. The medicine will be studied first in healthy people, who will be given a very     small amount of the medicine once. If the smallest amount of medicine is found to be safe, a     slightly higher amount will be given to a new group of volunteers. The highest amount that     will be tested is similar to the amount given to animals. If the medicine can be given safely     to healthy people in the planned amounts, a later study will be done in people who have worms     to see if the medicine kills the worms.   "
129933|NCT01584336|"     The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted     total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This     study will performed via prospective, multicenter design.   "
129934|NCT01584323|"     In this study the investigators sought to determine the effects of Pomegranate (Natural     pomegranate polyphenol (P. granatum L) extract) :        1. On the maternal and fetal oxidative stress and inflammation associated with PPROM.        2. On the time interval from PPROM to delivery and on fetal Ph and apger score.   "
130237|NCT01580306|"     The main objective of this study is to investigate the influence of mild, moderate and severe     renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control     group with normal renal function after single dose of BI 201335.   "
129935|NCT01584310|"     Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss     or insufficient weight gain, is related to an increase in morbidity and mortality and exposes     the child to medical complications. In addition, obesity is also related to complications     during hospitalization and complications in general, and therefore early identification of     these children is extremely important. Studies show that malnutrition is frequent among     children upon hospitalization, where the risk of pediatric nutritional deterioration     increases, even in the presence of mild stress factors. This risk is frequent mainly among     children that arrive at the hospital with an initial poor nutritional status. Improving the     nutritional status as part of the standard of care already at the ambulatory setting might     improve the prognosis of children when ill. In Israel, nutritional screening in not conducted     among children since there is no proper validated screening tool. Study objectives: To test     the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to     be used by nurses, and to compare it to a complete nutritional assessment conducted by a     dietician in Clalit Health Care Services clinics. In addition, the investigators wish to     examine the effects of using a screening tool for nutritional risk on the medical staff's     attention to the nutritional status; this is measured by the collection of nutritional     status-related data and their recording in the patient file.      Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric     Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3     questions with a summary score, according to which the nutritional risk level shall be     determined. These children shall also undergo a complete dietician assessment in order to     examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the     beginning of the research and after 6 months in order to estimate the change in medical     staff's attention to nutritional status, by way of noting relevant diagnoses, reference to     nutritional status- related tests and recording of anthropometric measurements.      A statistical analysis to examine the validity of the STAMP Tool shall be carried out using     the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi     square test.   "
129936|NCT01584297|"     Our proposal is to conduct an open phase II clinical trial that allows us to explore the     activity of ketoconazole, an inhibitor of the enzyme CYP17, in ovarian granulosa tumors     similar to what has been done in prostate cancer. The rational is based on dysregulation that     FOXL2 mutations present in almost all granulosa tumors result in the expression of CYP17 that     appears to be key in the development and progression of the disease.      This work would represent the first attempt to address the treatment of ovarian granulosa     cancer with a molecular solid rational, drawing on the recent identification of the mutation     leader of this tumor. If succeed provide a widely available therapeutic alternative     compared with current cancer therapies, with low toxicity. In addition it would open a new     line of research with CYP17 enzyme inhibitors that could alter the course and outcome,     usually fatal, in advanced stages of disease.   "
129938|NCT01584271|"     Phase II 3 arm double blinded clinical study, to evaluate pain killing and healing time of     Botanical Ear Drops, Ear Comfort™, in Severe External Ear Infection (AOE) patients in     comparison to Dex-Otic® and Otidin®.      Study Outcome (hypothesis): if Ear Comfort™ proves to perform as well as Dex-Otic, then ENT's     and family doctors will have a botanical non-antibiotic product that does not promote the     formation of antibiotic-resistant infections and may be given to anti-biotics sensitive     patients.      Ear comfort™ is pharmacologically stable for at least 3 years on the shelves.   "
129939|NCT01584258|"     This study is an international multicentre randomised study of organ confined low and     intermediate risk prostate cancer and is composed of two parallel randomisation schemes based     on applicability of surgery as a treatment for the patient. Patients for whom surgery is a     consideration are randomised to either laparoscopic prostatectomy or prostate SBRT. Patients     for whom surgery is not a consideration are randomised to either conventionally fractionated     radiation therapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be     compared across the pairs in each randomisation.   "
129940|NCT01584245|"     This clinical trial will evaluate the efficacy of an amino acid formula in infants with     allergic manifestations.   "
129941|NCT01584232|"     The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265     (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic     medication (OAM).   "
129942|NCT01584219|"     Immature myeloid cells (IMCs) that are generated in the bone marrow, and differentiate into     mature granulocytes, macrophages and dendritic cells (DCs) in the steady state. Recently, it     was demonstrated that the IMC population expands in malignancy, both in animal models and in     humans. These cells were described as immunosuppressants but have also been shown to promote     tumor angiogenesis. Accordingly, IMCs were also found to take part in the burn injury wound     healing process and other pathologies that involve angiogenesis. It was shown in the     investigators' laboratory, that a very similar population of IMCs populates the mouse and     human placenta, and that these cells actively promote angiogenesis.      Dendritic cells (DCs) that can differentiate from IMCs, are antigen presenting cells (APCs)     that initiate and coordinate the innate and adaptive immune responses. DCs can take up a     diverse array of antigens and present them to T cells as peptides bound to MHC products.     These antigen-specific responses are critical for resistance to infection and tumors.     Conversely, DCs have roles in autoimmunity, transplant rejection and immunological tolerance.     In the reproductive system, DCs were shown to account for 5%-10% of all hematopoietic cells     in the uterine decidua at the embryonic implantation site. They were shown to promote     angiogenesis during early pregnancy, especially during implantation. Very little is known     about their function in the placenta and in the latter part of pregnancy when significant     angiogenesis takes part.      The investigators' preliminary mouse experiments and human data, demonstrate a shift in     IMC/DC populations with the development of the placenta. The investigators hypothesize that     this population shift may contribute to the labor and delivery process.      The investigators' aim is to understand the role of these myeloid cell populations during     pregnancy, to characterize their phenotype and try to shed light on the cellular and     molecular mechanisms of pregnancy complications, such as preeclampsia, pre-term labor,     intrauterine growth restriction, etc.   "
129943|NCT01584206|"     Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an     inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this     study is to determine if ezetimibe improves whole body plant sterol and cholesterol     homeostasis.   "
129944|NCT01584193|"     The purpose of this study is to compare two different surgical techniques for implementation     of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture     is compared to cephalic vein dissection.   "
129945|NCT01584180|"     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling     associated cerebrovascular disease. The narrow-time-frame is a major issue (time is brain).     To provide immediate cooling without delay, easy to use, mobile and effective methods are     needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Brain.Pad     (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling     system. A comparison of these two induction methods has never been done before. Neither was     the effect of the EMCOOLS Brain.Pad on brain-temperature measured. For the first time iCOOL 3     compares feasibility, safety and efficacy of the two methods.   "
131081|NCT01569269|"     The purpose of this study is to test whether people with symptoms of chemotherapy-induced     peripheral neuropathy (CIPN) receive physical or psychological benefits from participating in     a six-week Reiki, Yoga, Meditation, or Educational experience.   "
129948|NCT01584141|"     Background:      - Lymphoma rates in Asia have been lower than in the West, but rates have been rising in     recent years. Most studies of lymphoma patients have been conducted in the West. Less     information is available about the factors that might contribute to the rise of lymphoma in     Asia. Researchers want to collect medical and personal histories and samples from people who     have recently been diagnosed with lymphoma. This information will help them study possible     reasons for this increase.      Objectives:      - To collect samples and histories as part of an introductory study of lymphoma in Asia.      Eligibility:        -  People between 18 and 79 years of age who have entered study hospitals in Hong Kong,          Taiwan, and mainland China for treatment for any type of lymphoma.        -  Healthy volunteers between 18 and 79 who have never had lymphoma.      Design:        -  Participants will be screened with a physical exam and medical history.        -  They will provide blood samples and cheek cell samples for testing.        -  Participants will complete a questionnaire about their personal health history. They          will answer questions about exposures to chemicals like pesticides. They will also be          asked about family medical history and work and residential history. Finally they will          answer questions about lifestyle factors like diet and exercise.        -  They will give permission for the researchers to see their medical records. Researchers          will also have access to any tumor samples collected as part of treatment.   "
129949|NCT01584128|"     The goal of the investigators study is to determine whether the use of oxidized regenerated     cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff     dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize     that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff     cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic     hysterectomy.   "
129950|NCT01584115|"     This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability,     immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined     with the adjuvant MPLA from B. pertussis in cancer patients.   "
130397|NCT01578213|"     The purpose of this study is to assess the capability of the dPCR technique to predict the     absence of disease relapses after imatinib discontinuation in CML patients with negative     Q-RT-PCR results for longer than 18 months.   "
129951|NCT01584102|"     The intervention included biweekly access to group fitness classes, with (Group 1) or without     (Group 2) weekly nutrition and physical activity education sessions. Outcome measures were     assessed at baseline and immediately post intervention and included BMI, waist circumference,     blood pressure, physical activity and dietary behaviors, and psychosocial variables.   "
129952|NCT01584076|"     Amblyopia is the leading cause of monocular visual impairment in children and adults. Despite     conventional treatment with patching or eye drops, many older children and adults do not     achieve normal vision in the amblyopic eye.      Donepezil is an acetylcholinesterase inhibitor that increases levels of the neurotransmitter     acetylcholine in the brain. Use of acetylcholinesterase inhibitors has been demonstrated by     the Hensch lab (Department of Neurology, FM Kirby Neurobiology Center) at Boston Children's     Hospital to improve vision and reverse amblyopia in animal models.      The purpose of this study is to evaluate the efficacy of oral donepezil as treatment for     residual amblyopia (20/50 - 20/400) in patients 8 years of age and older.   "
129953|NCT01584063|"     Healthy Mothers on the Move (Healthy MOMs), was a prospective randomized controlled trial     that aimed to demonstrate the effectiveness of a healthy lifestyle intervention to reduce     risk factors for obesity and type 2 diabetes. This behavioral intervention was tailored to     the needs of pregnant and postpartum Latino women. This study was conducted between 2004 and     2006 in southwest Detroit.   "
129954|NCT01584050|"     Folic acid, a form of the vitamin folate, is added to grain products in Canada to help reduce     birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't break     down) when added to foods. There are emerging health concerns about chronic folic acid     consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate     (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women     to determine if supplements containing L-MTHF consumed over three months raises blood folate     levels as much as supplements containing folic acid. The investigators hypothesize that     L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.   "
129955|NCT01584037|"     The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect     data concerning:        1. Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,        2. Potential confounding factors, and        3. The outcome of these pregnancies.      The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the     frequency of birth defects in prospectively enrolled pregnant women. This Registry is also     designed to detect any unusual patterns of birth defects.   "
129956|NCT01584024|"     The purpose of this study is to determine whether lesion infiltration is an effective     management strategy to arrest early tooth decay.   "
129957|NCT01584011|"     Objectives      To evaluate the impact of taste disturbance in different types of chronic middle ear diseases     and after middle ear surgery.      Hypothesis      That patients with chronic otitis media and cholesteatoma has taste disturbance already     before surgery due to the disease itself, of course depending on degree of the disease.      That patients with otosclerosis, has a normal nerve function before surgery.      That patients with normal taste before surgery are more likely to notices a taste     disturbance.      That nerve in continuity after surgery, even if it is maltreated, gives less taste     disturbance than a divided nerve.      Methods      A clinical study has been launched that measures taste function with two different methods     for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD) before     and after middle ear surgery in patients operated with middle ear surgery because of     otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120     patients in this study.      A parallel study of the patients own experience of the symptom has also been launched were     the patients answer a questionary and a quality of life document. The investigators plan to     include 300 patients in this study.      A histological study where specimens of CTN from healthy ears and from ears with chronic     disease will be investigated with electron microscopy has also started.   "
130171|NCT01581177|"     The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety     profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg     per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI)     Active Control.      This study will be conducted in male and female adult patients who have mild-to-moderate     persistent asthma for at least 6 months, but are otherwise generally healthy.   "
129958|NCT01583998|"     The pilot study will evaluate whether electronic-Measurement Based Care (e-MBC) using the UT     Southwestern MyChart personal health record is feasible, associated with patient and health     care team satisfaction, and improves treatment outcomes compared to a standard treatment     model. The project will be conducted in the Simmons Cancer Center Clinic at the University of     Texas Southwestern Medical Center, Dallas as a collaborative effort between the Departments     of Psychiatry, Oncology, and Family and Community Medicine. The primary patient population     will include adults with significant depression and/or starting an antidepressant treatment     and/or experiencing a treatment change. The study will compare two groups, an e-MBC group and     an office-based standard care MBC group. Study staff will explain the study to the patients,     specifically explaining that study participants will receive either office-based MBC or     e-MBC. Eligible participants must be willing to receive either form of treatment monitoring.     Participating patients will be randomly assigned to receive either e-MBC or office-based MBC.     In the e-MBC group once a month the study nurse will send a prompt from the participating     patients treating physician requesting the patient to use the MyChart system to fill-out the     MBC scales. Beyond these monthly assessments, patients will be encouraged to utilize the     MyChart MBC assessments (e-MBC) at any time to communicate with their physician. Patients     experiencing difficulties using the e-MBC system will be given additional instruction by the     study nurse. Patients and physicians will be trained in the use of the eMBC system. In the     office-based MBC group the study nurse will schedule monthly treatment visits and request the     patient call as needed to report symptoms. The evaluation period will be 6 months.   "
129978|NCT01583803|"     Females have a lower incidence of hypertensive and cardiovascular disorders that may relate     to differences in nitrogen oxides in the blood and saliva. Some nitrogen oxides are recycled     with the help of oral bacteria to nitric oxide which is protective against vascular     disorders. This study will test the hypothesis that females have different numbers and     species of these nitrogen-oxide reducing bacteria.   "
129959|NCT01583985|"     Chronic musculoskeletal pain conditions are among the most prevalent conditions in VA primary     care. Over the past two decades, improved clinical attention to pain has been associated with     exponentially greater use of long-term opioid therapy for chronic non-cancer pain, both     within and outside the VA system. Despite this change in practice, the proper place of     opioids in chronic pain management continues to be controversial because research has not     demonstrated the long-term safety and effectiveness of opioids for chronic musculoskeletal     pain. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) Trial will     fill a critical gap in the evidence by comparing effectiveness and harms of two clinically     relevant analgesic prescribing strategies-one that emphasizes early use of strong opioids and     one that delays and minimizes opioid use-for Veterans with chronic back, hip, or knee pain.     SPACE is designed to be highly relevant to clinical decision-making in VA primary care and to     produce knowledge that will improve the lives of Veterans living with chronic pain.   "
129960|NCT01583972|"     Vitamin A supplementation at birth may increase survival of infants through one year of age     by reducing mortality from infectious diseases, though current studies are not conclusive on     this point. The goal of our study is to determine if supplementation of newborn infants with     50,000 IU of vitamin A improves aspects of immune function that may be impaired by vitamin A     deficiency. Our underlying assumption is that supplementation may thus decrease risk of death     by improving immune function and the ability to survive infections. This project will be     limited to the examination of the impact of vitamin A on immune function and will not aim to     determine the impact on morbidity or mortality, which would require larger sample sizes. The     hypotheses addressed by this study are as follows: Provision of vitamin A supplements to     newborns at risk of vitamin A deficiency will (1) improve functioning of the thymus (the     source of T lymphocytes, cells of the immune system that are important in response to     infection and immunization); (2) enhance T lymphocyte-mediated responses to standard vaccines     given at birth and early in infancy; and (3) improve gut barrier function (i.e., ability to     prevent bacterial infection across the epithelial barrier), relative to provision of a     placebo.   "
129961|NCT01583959|"     Introduction: Methotrexate is the sheet anchor for the treatment of rheumatoid arthritis.     Folic acid supplementation is usually given at a dose of 5-30 mg per week to ameliorate     adverse effects. Patients at our center are usually on the higher dose. However, it is     unclear if higher doses are required, recent international recommendations suggest 5-10 mg     per week only.      Objectives: To randomize rheumatoid patients being being started on Methotrexate into 2     groups- one on 5mg for 6 days a week (30mg per week) of folic acid and the other 5 mg twice a     week (10 mg per week) for 24weeks. To look at difference in        1. Adverse effects due to methotrexate           a. Minor adverse effects: By symptom chart           a. Major adverse effects: Cytopenia (predefined) and transaminitis.        2. Disease activity using Disease activity score 28 joints (3 variable) and functional          status by health assessment questionnaire        3. RBC folic acid levels Methodology: Randomised controlled trial, double blinded, placebo          controlled. Sample size 50 in each group. One group of patients will receive folic acid          5 mg twice a week with placebo for 4 days and the other group will receive folic acid 5          mg 6 days a week for 24 weeks.      Patients will be administered adverse effects proforma, assessed for having cytopenias and     transaminitis (pre defined) and disease activity will be calculated at every visit, ie., in     the beginning at then at 8,16 and 24 weeks. In addition will look at the functional status     and RBC folate levels at 0 and 24 weeks. Statistical analysis using chi-square test for     proportions and t test for continuous variables.   "
129974|NCT01583855|"     Atrial fibrillation is a common form of heart rhythm disturbance that for some patients is     treated by catheter ablation (making an ablation lesion or burn inside the heart using a fine     wire (catheter)). A new system for manipulating the catheters has recently been introduced     into clinical practice (the Amigo Remote Catheter System (RCS)). This trial is designed to     answer two primary questions: a) is the contact force (the force with which the catheter     comes into contact with the heart) any different using the RCS to manual techniques,and b)are     the resulting ablation lesions within the heart any different in terms of the volume and     contiguity of the lesions produced. Additionally the investigators aim to determine how the     two techniques compare in success (the proportion of patients whose heart rhythm disturbance     is corrected by the procedure).   "
130172|NCT01581164|"     The purpose of this research study is to perform a serial analysis of immune function using     blood cells and sera obtained from patients after vaccination following hematopoietic stem     cell transplantation (HSCT). The focus of this study will be to characterize several immune     parameters during the clinical course of HSCT and correlate these findings with the effect of     vaccination.   "
129962|NCT01583946|"     As individuals age, they undergo transitions in many aspects of their lives. These     transitions include social, economic and health transitions. People review their lives, and     reflect on past choices. Future time is limited by the increasing proximity to end of life.     This may lead to regrets and, in people with the ability to use compensatory mechanisms, a     redoubling of efforts to achieve valued goals or a reprioritization of valued goals. In the     context of aging, individuals' past, present, and future-oriented subjective well-being (SWB)     may change. There is an incomplete understanding of the relationship of SWB, intra- and     inter-personal resources, and outcomes, (particularly health and healthcare-cost outcomes).     These issues have complicated the use of SWB measures and the investigators are left with     traditional metrics such as life expectancy, infant mortality, wealth, and poverty to assess     healthy aging, resulting in an incomplete picture of healthy aging. This project will examine     the relationships among SWB, intra- and inter-personal resources, and health and     healthcare-cost outcomes. It will advance the understanding of SWB and its role in healthy     aging in order to assist policy makers in valuing the potential benefits of improving SWB on     health and healthcare costs. The investigators will accomplish this through the following     specific aim:      Aim 1: To determine how SWB (past, present, and future-oriented): (1) is affected by life     transitions, and (2) affects outcomes after life transitions.   "
129979|NCT01583790|"     The purpose of this study is to report data with patients after bariatric surgery.   "
129980|NCT01583777|"     The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of     belinostat following IV administration in patients with a recurrent or progressive     malignancy.   "
129963|NCT01583933|"     There are several factors involved in the decision and the retention plan, such as occlusion,     patient age, etiology of malocclusion, the speed of the correction, the length of the cusps     and health of the tissues involved, relationships inclined planes, size of the arches,     harmony of the arches, muscle pressure, interdental proximal contact, cell metabolism and     atmospheric pressure. Given these concepts, we need to find grounds to enable decision making     with respect to the retainer that offers the best features of containment and stability.   "
129964|NCT01583920|"     Radiation therapy is considered a standard treatment option for the management of localized     prostate cancer. Among the 20-30% who recur, a proportion of them will present with an     isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as     a source for subsequent metastases. Salvage options available for isolated local recurrence     include; temporary or permanent implantation of radioactive seeds into the prostate, complete     removal of the prostate gland, use of low temperatures to treat the disease, and high     frequency ultrasound to treat the disease. There are risks of complications associated with     all these treatments, and there is presently no consensus as to which treatment is the best.     Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal     treatment of the prostate using temporary implantation of radioactive seeds into the prostate     which the investigators hope will be less since the entire prostate is not treated.   "
129965|NCT01583907|"     The investigators aim to asses the effect of dieto-therapy and of nutritional counseling on     the nutritional status, body growth and tolerance acquisition in children with cow's milk     allergy.   "
129966|NCT01583894|"     This study will collect pain-related information from chronic pain patients to gain an     understanding of the prevalence of multi-site pain, and how it affects health outcomes like     function, quality of life, depression, and anxiety.   "
129967|NCT01583881|"     Increasing evidence suggests an important role of activation of the sympathetic nervous     system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection     fraction and hypertension. The current study aims to evaluate efficacy and safety of renal     sympathetic denervation for the modulation of the SNS in patients with heart failure with     normal LV ejection fraction.   "
129968|NCT01582815|"     The purpose of this study is to evaluate the efficacy and overall safety and tolerability of     treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety     symptoms being treated with an antidepressant.   "
129969|NCT01582802|"     Multiple births in the United States are rapidly increasing in large part due to assisted     reproductive technologies. Recent data indicate that multiple births now comprise 3-4.5% of     all births in the United States. Pregnant women are at risk for iron (Fe) deficiency anemia     yet there are virtually no data on Fe status in women carrying multiples and current     recommendations do not necessitate Fe screening among this high risk group. Maternal anemia     is known to increase the risk of adverse birth outcomes including preterm birth and low birth     weight. Moreover, the developing brain is increasingly recognized to be susceptible to Fe     insufficiency in utero and growing data support that suboptimal Fe stores at birth are     associated with long-term irreversible cognitive deficits in the offspring. To address these     gaps in knowledge the investigators will monitor weight gain, hematological measures, Fe     status indicators and serum hepcidin across pregnancy in approximately 120 women carrying     twins and triplets. Determinants of maternal anemia will be identified. Neonatal     hematological measures will be assessed in cord blood from each neonate at birth for     assessment of hematological measures, Fe status and hepcidin. Determinants of neonatal anemia     will be identified. Inflammatory markers will be measured in all blood samples and related to     outcomes. Stable iron isotopes will be given to a subset of women to assess maternal Fe     absorption and fetal Fe uptake.   "
129970|NCT01582789|"     The purpose of this study is to obtain objective and subjective clinical data to compare the     performance of two soft contact lenses.   "
129971|NCT01582776|"     This study is to determine first the appropriate dose of lenalidomide to administer in     combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma     patients.      In a second step, this study aims to determine the efficacy of this combination in 3 separate     populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and     mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and     previously untreated follicular lymphoma (cohorts 3 and 4).   "
129972|NCT01582763|"     International GBS Outcome Study (IGOS) is a study conducted by the members of the     Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course     and outcome in Guillain-Barré syndrome (GBS).      The IGOS aims to identify clinical and biological determinants and predictors of disease     course and outcome in individual patients with Guillain-Barré syndrome, as early as possible     after onset of disease.   "
129973|NCT01582750|"     The purpose of this study is to determine the role of endoscopic ultrasound measurement of     the primary tumor maximum diameter changes in absolute / relative values in predicting the     tumor regression after concurrent chemoradiotherapy for rectal cancer.   "
129975|NCT01583842|"     This is a pilot study with the primary purpose to describe organ dosimetry and acute     toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with     neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or     refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.     After all eligibility criteria are met, patients will receive a diagnostic imaging dose of     124I-MIBG followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Subsequent,     planned therapeutic administration of 131I-MIBG will occur between Days 7 to 21, as specified     by the patient's therapeutic MIBG protocol. An optional single follow up 124I-MIBG PET-CT     scan will be done to assess tumor sites 6 weeks after the patient has their MIBG therapy.   "
129976|NCT01583829|"     This study examines the efficacy of two computer-based attention training systems, one with     and one without neurofeedback. The training systems intend to help children learn to focus     and attend more effectively.   "
129977|NCT01583816|"     A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple     Actinic Keratosis Lesions   "
129981|NCT01583751|"     This study examines performing pilonidal sinus surgery minimal invasively with     videoendoscopic approach.   "
129982|NCT01583738|"     Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.   "
129983|NCT01583725|"     The investigators are looking at the differences in appetite and obesity between weight loss     participants and patients undergoing bariatric surgery.      Obese persons between the ages of 18 & 65 are eligible to participate in this study, whether     or not they intend to undergo bariatric surgery.   "
129984|NCT01583712|"     Early diagnosis of acute Gastrointestinal Graft-versus-Host disease (aGI-GvHD) has a strong     impact on morbidity and mortality of patients who underwent haematopoietic stem cell     transplantation (HSCT). Recent results at the investigators department showed that mucosal     biopsies from the small intestine have a high diagnostic yield for aGI-GvHD specific changes.     By performing an enteroscopic examination, aGI-GvHD suspected patients can be prevented from     colonoscopy and prior bowel preparation which is clinically important, considering the rather     bad general condition of this patient group. To further reduce invasive procedures the     investigators want to evaluate the in vivo histological features of aGI-GvHD in the small     bowel. Therefore aGI-GvHD suspected patients will undergo confocal laser endomicroscopy of     the upper GI-tract, including duodenum and jejunum, in the context of a prospective clinical     pilot trial. The histological evaluation of biopsy samples taken from these sites will be     used as comparable gold standard. Endomicroscopic aspects of patients with celiac disease,     infectious enteritis, inflammatory bowel disease and healthy subjects should serve as     controls. If it is possible to diagnose aGI-GvHD from endomicroscopic features of the small     bowel alone, this could be another important step to improve the diagnostic management of     post HSCT patients, especially when taking of biopsy samples is difficult because of a bad     coagulation status. Additionally, an accurate diagnosis in vivo could lead to immediate     treatment to prevent progression and site spreading of the disease.   "
129985|NCT01583699|"     Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue     (MALT-lymphoma) represents a distinct clinical entity and is the most common form of     extranodal lymphoma, with a predilection for the stomach. About 90% of gastric MALT-lymphomas     are associated with infection with Helicobacter pylori (HP) and eradication of the pathogen     leads to regression of the tumor in a high percentage of patients at early tumour stages.     Nevertheless, following complete remission after HP-eradication, the risk of relapse     justifies lifelong follow-up examinations. Supported by recent findings at the investigators     department, endoscopic controls should include a close examination of the small bowel, as     relapses can involve different gastrointestinal sites. To continue the investigators     diagnostic approach as well as to further improve the detection rate of MALT-lymphoma     relapses, the investigators plan to introduce the novel confocal laser endomicroscope (CLE)     into the diagnostic management of MALT-lymphoma patients. In the context of a prospective     clinical pilot trial the investigators aim to establish MALT-lymphoma specific CLE-markers     that can be used for the in vivo diagnosis of the disease. Comparing endomicroscopic     findings, drawn from the stomach and small bowel of 50 MALT-lymphoma patients who will     undergo staging or follow up endoscopies at the investigators department, to the histological     evaluation of biopsy samples as present gold standard, the investigators want to determine     whether CLE can provide reliable data for the accurate detection of MALT-lymphoma associated     changes. Endomicroscopic aspects of patients with chronic gastritis, gastric adenocarcinoma     and healthy subjects should serve as controls. In comparison to random biopsies which     represent the current standard, the investigators aim to prove, whether endomicroscopy will     find MALT-lymphoma lesions more accurately and thus help to spare patients unnecessary     biopsies.   "
129986|NCT01583686|"     Background:      The NCI Surgery Branch has developed an experimental therapy for treating patients with     metastatic cancer that involves taking white blood cells from the patient, growing them in     the laboratory in large numbers, genetically modifying these specific cells with a type of     virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the     patient. This type of therapy is called gene transfer. In this protocol, we are modifying the     patient s white blood cells with a retrovirus that has the gene for anti-mesothelin     incorporated in the retrovirus.      Objective:      The purpose of this study is to determine a safe number of these cells to infuse and to see     if these tumor fighting cells (anti-mesothelin cells) cause metastatic cancer tumors to     shrink.      Eligibility:      - Adults age 18-70 with metastatic cancer expressing the mesothelin molecule.      Design:      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo     a history and physical examination, scans, x-rays, lab tests, and other tests as needed      Leukapheresis: If the patients meet all of the requirements for the study they will undergo     leukapheresis to obtain white blood cells to make the anti-mesothelin cells. {Leukapheresis     is a common procedure, which removes only the white blood cells from the patient.}      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the     conditioning chemotherapy, the anti-mesothelin cells, and aldesleukin. They will stay in the     hospital for about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1     year as long as their tumors are shrinking. Follow up visits will take up to 2 days.   "
129987|NCT01583673|"     The primary objective of the clinical trial is to compare growth in infants (expressed as     weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially     available hypoallergenic formula over a period of 4 months.   "
130607|NCT01575470|"     The purpose of this study is to determine if bone marrow harvest, BMMNC separation, and     re-infusion in adults with acute severe TBI is safe and will improve functional outcome.      12/09/2015 Update: The study is closed to new enrollment and all follow-up visits have been     completed. Data analysis is underway.   "
129988|NCT01583660|"     With the development of society, aged population is growing. Hip fracture is the most common     disease for aged people. With the life being longer than before, incidence of this disease is     growing. The mortality of this disease is high—— almost 10% patients will die within 1 month,     about 1/3 of patients will die within 12 months. About 20%-30% aged people who have hip     fracture will die within one year.      The damaged organs caused by excessive inflammatory is one of possible reasons to cause     higher mortality. Therefore, the investigators imagined that if they gave medicines to     patients in time to reduce the inflammatory level, the inflammatory might have less effects     on organs, and the recovery could be improved.      The investigators hypothesis on the basic research: the anti-inflammatory function of non     steroidal antiinflammatory drugs (NSAIDs) can inhibit the inflammatory level of elderly hip     fracture, so as to improve the recovery level and reduce the complicating disease and     mortality. The investigators designed a clinic study to research NSAIDS' effects on     inflammatory level and prognosis of elderly hip fracture.   "
129989|NCT01583647|"     The purpose of this study is to determine the pharmacokinetics of laropiprant following     administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of     MK-0524A in adolescents with heterozygous familial hypercholesterolemia.   "
129990|NCT01583634|"     Accuracy of the oximeter.   "
129991|NCT01583621|"     Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3 supplementations     on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium.      Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3 supplementations     on non-invasive vascular measures including pulse wave velocity (PWV), flow-mediated dilation     (FMD), carotid arterial compliance (CAC), carotid Intima-Media Thickness (cIMT), and 24-hours     Ambulatory Blood Pressure (ABP) monitoring as well as casual BP.   "
129992|NCT01583608|"     The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting     bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery     lesions in all-day clinical practice.   "
129993|NCT01583595|"     Most patients with chronic lung disease underestimate their actual walking ability due to low     confidence. To better understand the relationships between lung function, self-efficacy for     walking (confidence in ability to walk a defined distance), actual walking ability for the     same distance gait speed and physical activity level-PAL- (total energy expenditure/resting     metabolic rate).      Quality of life, self efficacy for activity questionnaires, physical activity level     measurement, 4-meter gait speed and 6-minute walk distance will be measured.   "
129994|NCT01583582|"     The purpose of this proof of concept study is to find out the efficacy of Marealis Refined     Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing ACE-inhibiting     peptides on blood pressure in subjects with mild or moderate hypertension.   "
129995|NCT01583569|"     Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the     relationship between voice samples, heart rate, respiration, movement, galvanic skin     conductance, and sleep architecture with mood states in patients with Major Depressive     Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear     dynamic analyses will be able to reveal hidden patterns of complexity in each domain of     voice, heart rate variability, movement, arousal, and sleep stage data.   "
129996|NCT01583556|"     Many common arm fractures have an excellent prognosis with little more than symptomatic     treatment. When studying these fractures, investigators find that a substantial number of     patients do not attend follow-up appointments. The difficulty of maneuvering in big cities,     the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all     inconveniences that some patients might prefer to avoid. Building on prior research, it is     appropriate to offer patients with common minor upper extremity fractures that have an     excellent prognosis optional follow-up after the first visit. The plan would be to be     available by phone, email and subsequent appointment at the patient's discretion if they felt     that the recovery was off course. Benefit to individual participants is unlikely. The study     will benefit the society as a whole, by providing a better understanding of these common     fractures. It can also affect the economics of our health system by avoiding further     follow-up appointments.      Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury     between patients that return for a second visit, and patients that do not.      Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after     injury between patients that return for a second visit, and patients that do not.   "
129997|NCT01583543|"     This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult     participants with recurrent/metastatic Ewing's Sarcoma following failure of prior     chemotherapy.   "
129998|NCT01583530|"     The purpose of this study is to measure the amount of belimumab in the blood when given as an     injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of     multiple injections under the skin in healthy subjects.   "
129999|NCT01583517|"     The therapeutic impact of ERCP with sphincterotomy in the management of patients with     idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators     conducted a single center, feasibility, randomized trial to determine 1) the role of     pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy     of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).   "
130000|NCT01583504|"     Hypothesis: High volume saline injections are an effective pain relieving treatment for     people with longstanding pain in the achilles tendon which has not improved with a     physiotherapy programme.      Objective 1: To establish whether high volume saline injections are an effective treatment in     decreasing pain for people with achilles tendinopathy      Objective 2: To investigate whether high volume saline injections can improve day to day     functioning, quality of life and the ultrasound appearances of the tendon for people with     achilles tendinopathy      Objective 3: To assess the tolerability of the procedure and levels of patient satisfaction     using a simple questionnaire.      Objective 4: To follow up the cohort of people who have received the injection for 9 months     and ascertain whether any benefits persisted, or if the symptoms recurred.      Background: Achilles tendon disorders are a common problem for athletes with a lifetime risk     of around 50%. They are also common for less active people with a lifetime risk of around 6%.      Tendinopathy is a condition which is characterised by pain, difficulty with weight bearing     and swelling of the tendon. Symptoms may occur with exercise at first but can progress to     occurring at rest and interfering with day to day activities. When the problematic tendon is     examined under the microscope, it usually shows signs of degeneration rather than     inflammation - especially when symptoms have been persistent. An ultrasound scan will usually     show that the tendon is swollen with an increased water content and a disorganised tendon     structure.      A special type of ultrasound scan which looks at fluid flows, called a doppler ultrasound,     often shows areas of increased blood flow around the tendon. Studies have shown that when     these areas of increased blood flow are present, the patient tends to be experiencing more     pain and stiffness in the tendon. Under the microscope, these blood vessels are often     accompanied by nerve fibres and it has been suggested that these newly growing nerve endings     are responsible for the persistent pain that patients experience.      There is robust evidence that a particular type of exercise programme (eccentric loading) is     an effective treatment for achilles tendinopathy. These exercises involve taking weight on     the tendon whilst it is being compressed rather than stretched - heel lowering exercises.     Nevertheless after completing a 3 month eccentric loading exercise programme, around 24-45%     of patients will still have symptoms. There is no clear consensus amongst doctors as to what     is the best second line treatment to try for this group of people.      A number of different treatments have been described in research literature to try to treat     this group of people with persistent symptoms, although no firm conclusion can be reached.     There have been 2 small trials of high volume saline injections which showed some promising     potential for the treatment. The aim of this injection is to destroy the blood vessels and     nerve endings that grow into the swollen tendon to reduce pain and allow people to move and     exercise more normally using the tendon. These studies simply looked at before and after     injection results and did not compare the injections to a placebo or other treatment. The aim     of this project is to conduct a high quality comparison of this new type of injection against     a more common steroid and local anaesthetic injection around the tendon sheath. The design of     the trial is a double blind, randomised controlled trial. This means that neither the     patient, nor the doctor collecting data on pain scores knows which treatment the participant     has been given, allowing a fair comparison of the interventions.      The main comparisons between the 2 groups will take place at a 6 week follow up appointment.     Once outcome measures have been recorded by the blinded assessor, the participant will then     be told which arm of the study they are on. If they previously received the control injection     (steroid and local anaesthetic only)and they still have symptoms, they will at this stage be     offered the high volume saline injection as well. The investigators will then follow all of     the study participants up for 9 months to ascertain whether people show a persistent benefit     from the treatment, or whether symptoms subsequently return.      The full study protocol is available on request from the Principle Investigator, along with     information leaflets, ethical approvals etc.   "
130001|NCT01583491|"     The purpose of this study is to determine the influence of platelet rich fibrin to reduction     of periodontal problems after surgical removal of third molar.   "
130017|NCT01583283|"     The purpose of this study is to determine the best dose of ACY-1215 in combination with     lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple     myeloma. Once determined, the purpose of this study will be to determine the efficacy of     ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed     multiple myeloma who have had 1-3 prior therapies and who are not lenalidomide-refractory.   "
130173|NCT01581151|"     This study seeks to compare dexamethasone implant with rescue intravitreal ranibizumab to     monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or     central retinal vein occlusion. This is based on the null hypothesis that dexamethasone     implant with rescue ranibizumab has inferior best corrected visual acuity at six months     compared to monthly ranibizumab alone.   "
130002|NCT01583478|"     The objective of the study is to compare the efficacy and duration of escalating doses of     IncobotulinumtoxinA (Xeomin®) in the treatment of glabellar rhytids (frown lines between the     eyes). Fifteen subjects will be enrolled in the study; specifically 60 male or female     patients 18 years of age or older with moderate to severe glabellar rhytids at maximum     contracture. Each patient will be randomized to receive one of 5 doses of Xeomin®, in a     one-time dose to the treatment area.      The efficacy endpoints will be determined by investigator and subject live assessment of the     glabellar rhytids at rest and maximum contraction at each visit (every other day for 6 days     post-injection, every month for 9 months following) using a validated 4 point photographic     scale (minimal wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles     [3]) used in previous studies. A written description of each photograph will be included to     help standardize the application of the Photographic Scale.   "
130003|NCT01583465|"     The purpose of this study is to establish whether or not there is a clinical advantage to the     use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical     Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine     intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound     healing will be assessed by a blinded observer and based upon a simple and subjective     criteria: a) as expected, b) better than expected or c) worse than expected. The blinded     observer is experienced in the care of the surgical patient and wound evaluation.   "
130010|NCT01583374|"     Apremilast is a new, orally available, small molecule drug that specifically inhibits     phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical     study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.   "
130011|NCT01583361|"     This is a randomized, multicenter, controlled trial to prove efficacy of S‐1 and Oxaliplatin     as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.      The primary endpoint is three-year free disease and the second primary includes five-year     overall survival, safety and R0 resection rate.   "
130004|NCT01583452|"     Post- operative ileus refers to the time after surgery before coordinated electromotor bowel     function resumes. It's treatment and prevention may signify an elevated hospitalization cost     and the exposure to the patient to adverse effects of drugs.      The current clinical trial has as primary objective to prove the efficacy of chewing gum as a     preventive measure of post-operative ileus in pediatric patients after gastrointestinal     surgery through the determination of the time the patient takes to tolerate oral intake, pass     flatus, present bowel movements and the time of hospital stay.      Patients will be assigned either to the case group (chewing gum + standard treatment) or to     the control group (standard treatment), in both of them time from the end of surgery to the     moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any     type of food) and is discharged from hospital; will be measured in hours and then analyzed to     determine the validity of these data.   "
130005|NCT01583439|"     The goal of the Mochudi Prevention Project is to reduce the number of new HIV infections in     the village of Mochudi, Botswana by promoting a comprehensive package of interventions that     have proven to be effective in preventing the spread of HIV. This antiretroviral treatment     (ART) clinical study is nested within the Mochudi Prevention Project, and is being conducted     in the north-east segment (NES) of the village of Mochudi. The ART intervention component of     the Mochudi Project is designed to determine the uptake of, adherence to, and feasibility of     3-drug combination ART as a component of a package of transmission prevention strategies. The     hypotheses are 1) that ART (with 3 antiretrovirals from two classes of drugs) among     participants with CD4 ≥ 250 cells/mm3 and VL ≥ 50,000 cp/mL will be acceptable and safe and     2) Eighty percent of eligible participants will agree to start 3-drug ART.   "
130006|NCT01583426|"     Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast     cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles     of TAC based on previous large scale studies.      Treatment of patients with HER2-positive disease should include also simultaneous application     of trastuzumab.      Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active     agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a     solvent-free formulation of paclitaxel encapsulated in albumin. It does not require     premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated     hypersensitivity reactions. This new formulation improves safety profile, allows higher     dosing with shorter infusion duration, and produces higher tumor drug concentration.      As neoadjuvant treatment does not only allow to compare competing treatment approaches with a     very high quality (homogenous treatment population, precise assessment of response by     histological assessment), but also to identify predictive markers, this trial will compare     weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses.      In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab     additionally.   "
130007|NCT01583413|"     Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation     associated with significant morbidity, including prolongation of mechanical ventilation and     increased ICU and hospital length-of-stay. Numerous strategies have been proposed to decrease     the occurrence of VAP among ventilated patients. Most notably, optimizing the use of daily     sedative interruptions and daily spontaneous breathing trials can improve sedative     management, decrease ventilator time, improve outcomes for mechanically ventilated     patients,and possibly decrease VAP.Combining daily sedative interruption with daily     spontaneous breathing trials confers additive improvement in ventilator days, intensive care     days, and possibly mortality compared to daily spontaneous breathing trials alone.      The primary aim of this study is to determine the impact of an opt-out protocol for paired     daily sedative interruptions and spontaneous breathing trials on VAP rates using a new     streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's     proposed new surveillance definitions for ventilator-associated events to this quality     improvement initiative. The study will be nested within the Epicenters Streamlined versus     Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be     participating in this intervention arm.   "
130044|NCT01582932|"     Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects     with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for     the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a     multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11     years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary     caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and     scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of     calcipotriene will be evaluated.   "
130174|NCT01581138|"     The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in     subjects who have chronic hepatitis C and have not received treatment yet.   "
130008|NCT01583400|"     Primary care physicians have emerged as the predominant mental health care providers for     diagnosing and treating depression. The majority of patients with mood disorders receive     treatment in the primary care setting, within which approximately 10-30% of all patients     present with a depressive disorder. Comprehensive 'Collaborative Care' models of depression     management significantly improve depression outcomes and health-related quality of life. Core     features of these programs include use of a trained depression care manager to closely     coordinate with primary care clinicians, support treatment recommendations, provide patient     education, conduct patient follow-up to ensure adequate treatment, and manage as-needed     access to psychiatrists for patients with more complex presentations. Evidence based     Collaborative Care models do not currently weave in the use of web-based or mobile     technologies. These technologies offer unique features that may make collaborative depression     care more effective. The digital health coaching program for depressive symptoms enhanced     during Phase I of the current project is a web-based tool featuring video, text, links and     graphics which provide patients with education, self-management techniques, tailored     feedback, and tools for tracking treatment progress. The RESPECT-D (Re-engineering Systems of     Primary Care Treatment of Depression) intervention is a collaborative depression management     model for primary care. The primary objective of this project is to compare the efficacy of     an enhanced Collaborative Care model for depression (RESPECT-D-E) to the standard model     (RESPECT-D) for patients with minor and major depression and dysthymic disorder. This study     will be a randomized controlled trial with 150 participants who are receiving antidepressant     medication treatment in the primary care setting. The primary objectives are: reduction in     subject reported depressive symptoms, improvement in subject reported health related quality     of life and improvement in subject adherence to treatment regimen as demonstrated by     self-report measures and clinician-administered assessment. The investigators hypothesize     that compared to RESPECT-D at 12 weeks, participants randomized to RESPECT-D-E will     demonstrate: a greater reduction in depressive symptoms, a greater improvement in     health-related quality of life and a greater satisfaction with quality of depression care     received.   "
130009|NCT01583387|"     The main purpose of the study is to assess the effect of water intake on the formation of     4-ABP DNA adducts.   "
130398|NCT01578200|"     The purpose of this study is to demonstrate decrease in cardiovascular mortality and     morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with     those with Calcium carbonate.   "
130012|NCT01583348|"     While gold standard in the treatment of symptomatic gall stones is laparoscopic     cholecystectomy with instruments introduced through multiple abdominal wall incisions,     transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the     abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and     safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is     feasible during such procedure. This observational case series describes success and     technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy.     The investigators hypothesis is that cholangiography is feasible equal to conventional     laparoscopic cholecystectomy.   "
130013|NCT01583335|"     Obesity prevention should remain a priority, although there is some evidence of a possible     leveling off in some age groups across European countries and in USA, Japan and Australia.     Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity in     childhood is associated with psychological and social problems, low self-esteem,     stigmatization and being teased and bullied by friends. Danish research suggests that the     causes behind the increase in obesity occurrence are present already in early childhood, and     that prevention of obesity therefore has to start early. Research has suggested that at least     three sub-groups can be considered at high risk of becoming obese: Children with obesity     among their 1st degree relatives; children with a high birth weight or children coming from     socially disadvantaged families (low socioeconomic status). Earlier intervention programs has     showed little effect in preventing excessive weight gain and knowledge on how to develop     effective intervention programs that reduce overweight and obesity remains limited. It has     been suggested that future prevention programs may be more successful if specifically     targeting groups that are at high risk, as mention above, of excessive weight gain.      Based on these suggestions, the Sund Start project was initiated. The purpose of the study     was to determine whether aiming prevention towards 2-6 years old Danish children who were yet     normal weight, but were considered predisposed to becoming overweight or obese could prevent     later on risk of becoming overweight or obese. Furthermore, to investigate if it was possible     to improve diet habits, increase physical activity, reduce stress and improve sleeping habits     among children at high risk for later on overweight and obesity.      The Sund Start project will contribute with knowledge about whether targeting normal     weight, predisposed children is effective in preventing overweight and obesity, and if     reduced stress and improved sleep, should be considered important new obesity prevention     tools. Moreover, the project will contribute with knowledge about how to change lifestyle and     its effects on development of overweight and obesity in high risk Danish preschool children.   "
130014|NCT01583322|"     Patients with extensive and bulky disease are often those whose initial surgery is delayed     after 3 or 4 cycles of neo-adjuvant chemotherapy.      In that case, there is, indeed, some concern to administer bevacizumab during the     chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21     days) of this monoclonal antibody and the interference of anti angiogenic agents with wound     healing.      Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant     setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary     experience in cancer did not show a trend for increased incidence of fistula or bowel     perforation. For more details please refer to the investigator drug brochure for Vargatef®     (Nintedanib).      This trial will compare progression-free survival and surgical complications of 188 patients     with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy     (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef®     (Nintedanib).   "
130015|NCT01583309|"     Convective therapies have been proposed for improving chronic dialysis patient outcomes,     including intradialytic symptomatic hypotension.      To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different     types and doses of convective therapies compared with low-flux hemodialysis (HD), the     investigators performed a multicentre, open-label, randomized controlled trial.   "
130016|NCT01583296|"     The research plan involves two aims: 1) Cultural adaptation of the Panic-Asthma Treatment and     2) a randomized, placebo-controlled pilot study. Participants will be primarily recruited     from two major, inner-city hospitals in the Bronx, NY. Diagnosis of Panic Disorder (PD) will     be based on the Structured Clinical Interview for DSM-IV. Diagnosis of asthma will be based     on national guidelines. The first year of the project will be devoted to approximately 5     focus groups with Latino (primarily Puerto Rican) participants, pilot treatment and     participant feedback. The protocol will be adapted based on key cultural issues that are     systematically observed during Phase 1. During Years 2-3, 40 participants with PD and asthma     will be randomized into two treatment arms: Panic-Asthma Treatment and an active placebo     condition involving music therapy and paced breathing at resting respiration rates. Each     treatment will involve 8 weekly sessions. An interviewer, who will be blind to treatment     condition, will conduct assessments at pre-treatment, mid-treatment, post-treatment, and     3-month follow-up. The primary hypotheses are that participants in the Panic-Asthma treatment     group will have greater decreases than subjects in the placebo condition on the PD severity     scale and albuterol use (i.e., rescue asthma medication) from pre-test to post-test and     across 3-month follow-up.   "
130018|NCT01583270|"     Sedentary lifestyles and increasing obesity are main causes of the global increase in the     prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality,     particularly composition of carbohydrate play also a significant role. Barley, oat and rye     may in addition to reducing the acute post prandial glucose response also reduce glucose     response at a subsequent meal. Purified dietary fibre has been shown to reduce GI and affect     levels of satiety hormones. In contrast, our knowledge of the physiological effect of     arabinoxylan, which constitute a substantial part of dietary fibre in cereal products, is     limited in relation to second meal effects. The investigators also lack knowledge of the     second meal effect of arabinoxyan in combination with rye kernels.      Hypothesis: Porridge rich in arabinoxylan and/or whole rye kernels can increase the formation     of short chain fatty acids and improve the glycemic response.      The aim of the present study is to compare the effect of porridge test meals based on     purified arabinoxylan, rye kernels, a combination of arabinoxylan and rye kernels, and     semolina porridge as control on acute postprandial response as well as response at a     subsequent standardized meal. The study will be conducted in subjects with the metabolic     syndrome. The primary endpoint is glucose response. Secondary endpoints are the following     items: insulin, incretins, inflammatory markers, ghrelin, free fatty acids, metabolomics,     breath hydrogen and subjective satiety feeling.      This project will improve opportunities for identifying and designing foods with low GI that     is particularly suited to people who are at high risk of developing T2DM. The investigators     also expect to gain a greater understanding of the metabolic fingerprint, as seen after     ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods     affect health by altering metabolic processes. This will give us a deeper insight into the     metabolic processes that are necessary for maintaining normal glucose homeostasis   "
130060|NCT01582646|"     Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants     (ADs) are recommended as the first line treatment. In a murine model, the investigators     evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic     receptor stimulation and that β-mimetics display the same effect. These data support the idea     that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment.     This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.   "
130120|NCT01581853|"     Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while     Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago.     The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200     mg monotherapy once a day.   "
130019|NCT01583257|"     Background:      Renal transplant recipients have a greater risk of morbidity and mortality primarily due to     cardiovascular disease when compared to the general population. Cardiovascular disease is     responsible for 50% to 60% percent of deaths amongst renal transplant population and death     from cardiovascular disease is a leading cause of functioning graft loss.      Physical activity is an effective form of secondary prevention in existing cardiovascular     disease reducing all-cause mortality by 25%-30% and has demonstrated positive effects overall     on quality of life and well-being. Transplant patients who participated in regular     cardiovascular exercise have significant more positive scores on the SF-36 Health Status     Questionnaire in comparison to inactive transplant recipients.      Active video gaming is evolving as an innovative method to increase physical activity. Active     video gaming has supported physical activity in children and youth. There is however a     paucity of literature examining interactive games as a means to facilitate physical activity     and its impact on CVD and quality of life in the adult population nor any literature     examining AVG and its impact on an adult surgical population.      This pilot study is designed to determine if Active Video Gaming is feasible and is able to     lead to behavioral modifications and Quality of Life improvement.      Subject Selection:      This is a pilot study during which 10 patients who have undergone renal transplant will be     selected to exercise with Active Video Gaming for a duration of 3 months. The program     activity will begin 6 months post surgery.   "
130020|NCT01583244|"     The purpose of this post-marketing surveillance is to investigate and confirm the type and     incidence of newly identified adverse events and any other factors affecting safety and     efficacy of Orencia® so that the regulatory authority can manage the marketing approval     properly.   "
130021|NCT01583231|"     The aim of this research is to examine if the brushless scrub is effective in reducing     bioburden on the hands of the operating room (OR) personnel both with a prewash of one minute     prior to scrub and without a prewash prior to scrub, and to compare the bioburden reduction     between both methods.      Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases     bioburden than brushless scrub alone.      Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after the     application of the brushless scrub within 20 seconds of application for both groups.      Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5 minutes     after application of the brushless scrub for both groups.   "
130022|NCT01583218|"     The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban     can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for     an acute medical illness and to compare these results with standard of care enoxaparin. The     safety of betrixaban will also be studied.   "
130023|NCT01583205|"     The investigators propose to adapt and pilot test a behavioral intervention for recently     diagnosed patients with Amyotrophic Lateral Sclerosis (ALS), and/or a family care partner.     ALS fatal neurodegenerative disease, the diagnosis of which can have a devastating impact on     patients and their families. Our eight session intervention is derived from Coping     Effectiveness Training, a manualized intervention based on stress and coping theory. It is     designed to strengthen coping skills and alleviate distress following diagnosis.      Participants (patients and/or care partners) will be recruited from the Eleanor and Lou     Gehrig MDA/ALS Research Center, Columbia University. The main outcomes are changes in     distress level, depression and anxiety symptoms, and coping self-efficacy.      Once the investigators gain preliminary experience with the manual, get some sense of     feasibility and acceptance, and learn about patient and care partner reactions, the     investigators will be better able to prepare a grant application seeking NIH support for the     development of the intervention, with the eventual goal of a multisite randomized controlled     trial (RCT).   "
130024|NCT01583192|"     The study will prospectively compare the efficacy and safety of chloride hexidine soluted in     alcohol with povidine-jodine soluted in alcohol in forefoot surgery.   "
130025|NCT01583179|"     The patients included will be those who have already agreed to have a brachial plexus nerve     block for surgery. A flip of the coin will decide who gets and additive called buprenorphine     in their block or not. They will both contain the same amount and type of numbing medicine.     The goal will be to see if the additive extends the life of the pain control portion of the     ultrasound guided supraclavicular nerve block.   "
130026|NCT01583166|"     The purpose of this study is to determine if there is a difference in post-operative voiding     function between subjects receiving local anesthetic and those receiving placebo at the time     of mid-urethral sling placement. The secondary objective is to evaluate pain after the     procedure in the two groups.   "
130045|NCT01582919|"     It is now acknowledged that Alzheimer's disease is characterized by a long period of     pathophysiological change. Developing new strategies to achieve diagnoses as early as     possible has become a major goal for therapies aimed at slowing the progression of this     disease. While diagnoses currently rely principally on clinical neuropsychology, the typical     diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The     goal of our project is to identify very early imaging markers for Alzheimer's disease among     patients with no report of cognitive difficulties. In order to achieve this goal, we propose     a longitudinal study in an elderly population cohort.   "
130027|NCT01583153|"     Total knee replacement (TKR) surgery is a common and highly effective treatment option for     alleviating the pain and disability caused by chronic arthritis. The associated     rehabilitation costs, however, impose a significant burden on the health system. In     particular, inpatient rehabilitation - utilised by approximately 43% of private TKR     recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000     (AU) per inpatient episode.      The overarching aim of this study is to establish whether inpatient rehabilitation is     necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged     directly home.      The main hypothesis to be tested by the proposed study is that TKR recipients who receive     inpatient rehabilitation in addition to participating in a home programme, compared to     patients who participate in a home programme only, will achieve a superior level of mobility.     If superiority is shown, a cost-effectiveness analysis will be undertaken.      Secondary hypotheses to be tested relate to patient-reported knee pain and function,     health-related quality of life, functional ambulation, and knee joint mobility.      Superiority in these outcomes will be evident at six months after surgery.   "
130028|NCT01583140|"     In this study the investigators are specifically targeting Latina women because they are more     likely to be inactive and, therefore, are at higher risk for developing chronic conditions     like obesity, diabetes, or cardiovascular disease. Through focus groups and cognitive     interviews with Latinas in the Providence area, the investigators have modified our     print-based intervention, already tested and proven to be effective in English-speaking     communities, to be culturally and linguistically appropriate for the Latina community.      The objective of Seamos Saludables is to determine whether this culturally tailored print     intervention will produce greater increases in physical activity levels among Latina women     than a program focused on general health topics. Participants are randomly assigned to one of     two groups (exercise and general wellness) and attend 4 clinic visits to complete baseline     and follow-up assessments.      The investigators hypothesize that at the end of treatment, intervention participants will     report significantly more minutes of at least moderate intensity physical activity per week     than the wellness contact control participants.   "
130029|NCT01583127|"     To conduct a randomized controlled trial of School-Wide Positive Behavioral Interventions and     Supports, which is a school-based prevention program aimed at reducing behavior problems in     children.   "
130030|NCT01583114|"     This is a multicentre European double-blind,randomized and controlled trial with 2 parallel     groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors     (ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated     cardiomyopathy).      Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a     mutation (leading to a genetic form of heart failure) but have not yet developed DCM.      Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to     systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with     autosomal dominant inheritance, and underlying genes and mutations are increasingly     identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related penetrance     (or delayed-onset), that means that the cardiac expression of the disease (echocardiographic     abnormalities) is usually absent for a long period and progressively appears with advanced     age, usually after 20 years of age      Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical     stage).      Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge derived     from basic research (genes identification in DCM) will be translated into clinical practice     (early identification of subjects at high risk of developing heart failure through predictive     genetic testing) with the development of new therapeutic management (early ACEi) that will     help to decrease the morbidity and mortality associated with the disease. This will     constitute a paradigm of the development of preventive medicine thanks to the development of     genetics in the cardiovascular field.      Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible     for DCM and are at a preclinical stage of the disease. Total duration of treatment     (perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled     (100 in each group) in 7 centres.   "
130031|NCT01583101|"     The investigators have developed a novel decision support system for implementing clinical     guidelines in pediatric practice. CHICA (Child Health Improvement through Computer     Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a     dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing     electronic medical record systems. The result is a system that both delivers just-in-time     patient-relevant guidelines to physicians during the clinical encounter, and accurately     captures structured data from all who interact with it. Preliminary work with CHICA has     demonstrated the feasibility of using the system to implement and evaluate clinical     guidelines.      However, analyses have shown that physicians ignore a fair number of prompts. The     investigators would like to experiment with changes to the system to see if they can increase     physicians' response rates. This could include highlighting prompts, reordering them, or     flagging them in other ways. The main outcome of interest in the rate at which physicians     answer prompts.   "
130032|NCT01583088|"     ALS is is characterized by a progressive degeneration of motor neurons, leading to     progressive weakness of muscles, including respiratory muscles, the diaphragm. Although     specific therapy is lacking, correct respiratory therapy improves quality of life and     increases survival. Substituting the failing respiratory muscles by non invasive mechanical     ventilatory assistance (NIV) is the current standard of care. Intradiaphragmatic phrenic     nerve stimulation is a new treatment and has been the object of a preliminary international     proof-of-concept multicenter trial. This trial suggests that the intradiaphragmatic phrenic     nerve stimulation slows down the rate of decline of the diaphragm. Our new hypothesis is that     phrenic stimulation induces diaphragm conditioning and can delay the need for mechanical     ventilation in ALS patients. We will study, during 24 months, 2 groups of 37 patients at the     beginning of the respiratory dysfunction, using a intradiaphragmatic phrenic nerve     stimulation in one group and a sham stimulation in the other group. Although, all the     patients will be implanted, thus, at the end of the study, all the patients will receive     effective stimulation.   "
130033|NCT01583075|"     The single-ring ablation method aims for isolation of the posterior LA wall including the     pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.      Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided     single-ring ablation method as compared to standard RMN-guided circumferential PVA.   "
130057|NCT01582685|"     The investigators hypothesize that exercise in postmenopausal breast cancer survivors will     result in an increase in the plasma concentrations of angiostatic factors and a decrease in     the plasma concentrations of angiogenic factors. Exercise is expected to result in a     circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer     tumor, growth of microscopic residual disease after breast cancer resection, decreases rates     of local-regional recurrence, decreases rates of distant recurrence, and increases survival.   "
130059|NCT01582659|"     Constipation is a condition often seen in children. Constipation is often associated with     impaired quality of life of the child and of great concern among parents. Despite the fact     that both diagnosis and treatment is a simple task, it is often seen that the treatment     fails, and many children are referred to a pediatric ward for specialized treatment.      There is currently little research on the subject and treatment is therefore based on expert     knowledge rather than scientific research.      The study objective is to identify the most effective and least stressful treatment of     children with constipation for both families and the health care system.      The following will be tested:      Does treatment of constipation in children require specialized knowledge and extensive     resources or can the treatment be simplified?      The results from this study are expected to form the basis for a evidence based treatment of     children with constipation.   "
130180|NCT01581060|"     The aim of part 1 of this study is to determine the optimal biological dose (OBD) and maximum     tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the chronic     treatment in part 2. The aim of part 2 is to further determine the safety and tolerability of     chronic treatment with WX-554.   "
130034|NCT01583062|"     Facial fractures make up a significant proportion of injuries in trauma patients. Treatment     of these fractures often results in standard surgical interventions. While up to the early     1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its     efficacy is well accepted today. Chole and his team could show that the administration of     antibiotics one hour preoperatively and eight hours after the intervention reduces the     incidence of infectious complications in facial fractures from 42,2% to 8.9%. However there     is still no consensus about the duration of the postoperative administration. In literature     postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration of     7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with     allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial     resistance. In addition some authors assume that a prolonged administration of antibiotics     might increase the risk of infectious complications via superinfection. On the other hand a     short term or single shot administration might not be enough to prevent the onset of an     postoperative infection. Up to date there is no standard to support the administration of     antibiotics after surgical repair of a facial fracture.      The purpose of this prospective, randomized double-blinded trial is to investigate the     utility of antibiotics administered in the postoperative period after surgical revision of     facial fractures.      Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally effective     as a long-term administration of 5 days in facial fractures.   "
130035|NCT01583049|"     Primary objective: This is a descriptive study and the primary objective is to determine the     incidence of injection site and systemic adverse events after Triaxis administration as a 5th     dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children   "
130036|NCT01583036|"     An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite     NAMR on the pharmacokinetics of digoxin in healthy volunteers   "
130037|NCT01583023|"     The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation     (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion.   "
130038|NCT01583010|"     Needle tip visualization, although fundamental to the safety and efficacy of     ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is     most marked at steep insertion angles. Studies in patients with UGRA demonstrate that     echogenic needle designs have the potential to offer improved visibility and accuracy.      Our study pursues another approach. We use (for differentiation) echogenic nerve block     needles with ANV®, a new SonoSite software-upgrade (Advanced Needle Visualization     Technology®). We will compare UGRA with ANV® against standard UGRA without using this     SonoSite software-upgrade. Patients undergoing femoral, supraclavicular or other nerve blocks     as part of their routine anesthetic management are included.      This work represents the first randomized controlled double blinded clinical trial of ANV® in     patients undergoing UGRA. We hypothesize, that we can decrease the time without needle     visualization (Loss of needle time in percentage of procedure time) during in-line regional     anaesthesia. Furthermore we will record quality of visibility, duration of procedure and     insertion angle of the needle.   "
130039|NCT01582997|"     BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This     study will be designed to assess safety, tolerability, single and repeat dose PK profile and     preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive     solid tumors using continuous daily dosing schedule.   "
130040|NCT01582984|"     A structured consent process, in combination with one or a number of the aforementioned     modalities (nursing education, handout, video, etc), may reasonably be expected to improve     surgical informed consent. The investigators hypothesized that overall patient     knowledge/retention would be influenced by the type of consent process and that more     intensive training and review would result in better patient retention and recall. The     investigators further hypothesized that the knowledge retention would decline following the     consent process and surgery, but in a stratified manner based on the nature of preoperative     teaching.   "
130041|NCT01582971|"     The purpose of this project is to test foot reflexology delivered by a friend or family     member in the home for women with breast cancer. The primary aims of the proposed study in a     sample of women (post-attrition n=200) with breast cancer receiving chemotherapy and/or     hormonal therapy are to determine the effects of 4 family- or friend-delivered weekly     reflexology sessions compared to an attention control group.   "
130042|NCT01582958|"     This project proposes to test the hypothesis that osteopathic manipulative treatment (OMT)     given to patients with moderate to severe chronic obstructive pulmonary disease (COPD)     enrolled in a 12-week pulmonary rehabilitation program (PRP) will result in improved     respiratory pump function over and above that seen in sham and control groups. Specifically,     we will study the effects of three OMT techniques: (a) thoracic inlet indirect myofascial     release; (b) rib raising with continued stretch of the paraspinal muscle to the L2 level; and     (c) cervical paraspinal muscle stretch with suboccipital muscle release. The key clinical     readouts will include: spirometry, P100 (and index of diaphragm and inspiratory muscle     efficiency), maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), as     well as laser evaluation of chest wall excursion. Supplementing these objective parameters     will be several more subjective clinical outcome measures: exercise tolerance (6-minute walk     test), dyspnea (shortness of breath questionnaire), and quality of life questionnaire.     Finally, an attempt will be made to correlate biochemical alterations that may shed light on     the biological mechanism underlying the OMT procedures.   "
130043|NCT01582945|"     Ketamine infusion has been shown to have rapid antidepressant properties, however the     possible use of ketamine in treatment-resistant depression as augmentation has not been     investigated. The overall aim of this study is to assess the feasibility, safety and     tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate     antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in     subjects with severe treatment-resistant depression (TRD).      This is an open-label study (pilot).   "
130058|NCT01582672|"     This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal     Cell Carcinoma. The purpose of this study is to determine whether there is an overall     survival (OS) benefit between subjects treated with AGS-003 in combination with standard     treatment versus subjects treated with standard treatment alone.   "
130046|NCT01582906|"     After treatment women surviving gynaecological cancer may experience lateeffects and longterm     challenges specific to their disease and treatment resulting in functional deficits and a     reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research     on best models of posttreatment rehabilitation support for women posttreatment for     gynaecological cancer is limited. The primary objective of this study is to determine if     there is any additional benefit, over usual rehabilitation care, of additional rehabilitation     appointments to develop a survivorship care plan on cancer specific health related quality of     life.      Secondary objectives are to determine any additional benefit to general selfefficacy, generic     health related quality of life or social and health economics for patients who have completed     treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives     of the intervention. The study will be open to patients attending the outpatient     gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed     treatment for Stage I or II gynaecological cancer. They will report that they have     experienced a physical or psychosocial need resulting from the disease or its treatment; be     aged over 18 years and be willing and able to articulate their needs. The study will last for     six months for each participant. It will involve completing questionnaires and attending two     extra rehabilitation appointments to develop a survivorship care plan at the hospital may     also include attending for an interview about being involved in the study for those     randomised to the intervention group   "
130047|NCT01582893|"     Chronic dialysis patients with end stage renal disease have an increased mortality rate as     compared to the age matched healthy population. It is known that chronic inflammation     contributes to the high incidence of cardiovascular events in chronic dialysis patients.     Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be     beneficial in the elimination of inflammatory mediators and may improve the inflammatory     status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100     will improve the inflammatory status of chronic dialysis patients.   "
130048|NCT01582880|"     The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A     (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston     KPro) in patients with higher risk for corneal melting (keratolysis).   "
130049|NCT01582867|"     The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration     treatment.   "
130050|NCT01582854|"     The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in     subjects with post stroke cognitive impairment (PSCI) during a six month treatment period     compared to subjects administered placebo. Subjects received IV infusions whilst in hospital,     and tablets once discharged. Subjects were followed up for a further six months after their     treatment had been stopped to explore if the cognitive symptoms of the subjects treated with     Actovegin showed sustained improvement. The trial also explored the possible prevention of     dementia with Actovegin in patients who had suffered a recent ischaemic stroke, as well as     the effect of Actovegin on other stroke outcomes. Safety information on Actovegin was     collected.   "
130051|NCT01582841|"     The investigators research mobilizes the resources of an integrated health-delivery system     with extensive electronic clinical data to implement and evaluate a new strategy to maximize     screening of Colorectal Cancer (CRC) patients for Lynch Syndrome.   "
130052|NCT01582828|"     Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the     surgical (epicardial) approach seems to be the most effective. Still, however a significant     amount of failures exist which is mostly due to incompleteness of the surgical ablation     lines. Checking, and if necessary additional ablation, of these lines afterwards     endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this     problem.   "
130053|NCT01582737|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Xarelto for SPAF.      The objective of this study is to assess safety and effectiveness of Xarelto using in real     clinical practice.      A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational     period. An annual follow-up survey will be conducted for 5 years at the longest after     standard observational period.   "
130054|NCT01582724|"     The aim of the study is to evaluate the effectiveness of additional self-care acupressure in     women with menstrual pain compared to usual care alone.   "
130055|NCT01582711|"     The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT,     SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients     diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The     primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly     rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to     self-administered therapy (SAT). The secondary objectives:        -  To compare the treatment completion rates between participants randomized to SAT without          reminders versus SAT with weekly SMS reminders        -  To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among          participants who complete treatment and those who discontinue therapy prior to          completion.        -  To determine the availability and acceptability of using SMS reminders among all          patients consenting to participate in the study.        -  To determine the toxicity and tolerability by comparing the rates of any drug-related          grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined          and individually)        -  To compare the frequency, timing, and causes for failure to complete treatment between          the DOT arm and the SAT arms        -  To collect patient-specific cost data related to the 3 treatment arms        -  To describe the pattern of antituberculosis drug resistance among Mycobacterium          tuberculosis strains cultured from participants who develop active TB.   "
130056|NCT01582698|"     The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after     the first booster TBE vaccination with FSME-IMMUN 0.5ml.   "
130069|NCT01582529|"     The purpose of this study is to learn about the relationship between family factors and     developmental and psychosocial outcomes in children with congenital heart disease at 6 years     of age. A secondary purpose is to learn more about psychosocial outcomes in children with     congenital heart disease and their families over time.      About 250 mothers and fathers at 15 medical centers will take part in this study; 35 will be     from Children's Hospital of Wisconsin.   "
130061|NCT01582633|"     This study will evaluate the immunological response and the safety profiles of seasonal,     inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 pandemic     influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full     dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group     with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60     years old.      Reduced doses into the skin will be delivered by an investigational intradermal model of a     licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA     manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and     dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also     rapid and simple and overcomes the difficulty and patient discomfort of the traditional     Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin     testing.      Participants will be assessed for local and systemic adverse events by clinical observation     immediately after injection and then upon return on day 21 after each injection. In addition,     investigators will call participants by telephone on days 2 and 7 days to collect information     local and systemic side effects.      Serum will be collected on day 21 after each injection, and assayed for hemagglutination     inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de     Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant.     Information about the adverse events would be collected on days 1, 3 and 7 after dose     delivery. The investigators assessing adverse reactions will be blinded to the study arm to     which each subject was allocated.      The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each     dose in accordance with international parameters which include: seroconversion or significant     title increase (SCR), the frequencies by study arm of seroprotection defined as a     post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of     post-vaccination sera.   "
130062|NCT01582620|"     The purpose is to study the clinical, technological and organizational impacts of a     telestroke service between Nordlandssykehuset, Bodø, and two small rural hospitals in Lofoten     and Vesterålen. The stroke specialist in Bodø will examine the patient in cooperation with     the doctor at the local hospital through video- and sound communication. Radiology images are     transmitted using the RIS/PACS system.      Telestroke consultations may be useful to assess whether the patient needs thrombolysis     medication, and also whether there is a need for more advanced specialist neurological or     neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit.      The study design is a multi-method approach using before-and-after hospital information data     as well as registration forms monitoring patient outcome and pathways. The research questions     will be approached from medical, organisational and technological perspectives.      A telestroke service in North Norway is expected to face other challenges than those reported     internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of cases is     low, clinicians have high turnover, technical support is not available 24/7 and severe     weather conditions and long distances might add to the transport time.      Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and     proper treatment      Secondary hypothesis: Telestroke leads to improved overall patient treatment   "
130063|NCT01582607|"     The purpose of the investigators study is to compare the clinical effects and side-effects of     these three local anaesthetics as sole agents or with the supplementation with fentanyl for     c-section, especially when administered in doses achieving approximately an ED 50.   "
130064|NCT01582594|"     To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test     using known anti-HCV seropositive and seronegative specimens.      Registration for license application   "
130065|NCT01582581|"     The purpose of this study is to evaluate a computer-guided, telephone-based therapy for     adolescent depression, delivered in a pediatric primary setting in the community.   "
130066|NCT01582568|"     The primary objective of this study is to assess perianal and perirectal fistula healing     (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI     (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no     fistula (new or recurrence) in treatment of Crohn's' disease patient with Certolizumab     (Cimzia).   "
130067|NCT01582555|"     Nasal irrigation techniques have been used for many years and been shown to improve symptoms     of rhinosinusitis. Although there is a wealth of literature available, establishing treatment     protocols can be difficult because of the great variability in recommended composition     (seawater or hypertonic or isotonic saline with or without additives) and irrigation     technique (variations in pressure and volume). Nasal irrigation is also used in many centers     as part of postoperative treatment protocols and in particular has been recommended following     endoscopic sinus surgery (ESS). Nasal crusting and thick nasal discharge have a negative     impact on these patients quality of life (QOL). At the time of our study, there are no     studies comparing irrigation with mucolysis with saline irrigation following ESS. The     investigators aimed to assess whether mucolysis is effective at improving patients QOL and     reducing postoperative signs as assessed endoscopically.   "
130068|NCT01582542|"     The purpose of this study is to prospectively assess whether Desmopressin, given for a period     of month to patients after radical cystectomy with orthotopic bladder reconstruction,     improves and lowers the rate of nocturnal enuresis.   "
130175|NCT01581125|"     The purpose of this study is to test the hypothesis that sleep and performance depend on     length of time awake, length of time asleep, the amount of sleep over several sleep episodes,     and circadian phase.   "
130617|NCT01575340|"     The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil     modifies inflammatory markers in individuals with colorectal cancer in chemotherapy   "
130085|NCT01582308|"     A five-period crossover study to assess and compare the trough dipeptidyl peptidase IV     (DPP-4) inhibition at 24-hours following the final morning dose for sitagliptin, saxagliptin     and vildagliptin after 5 days of once daily dosing and vildagliptin after 5 days of twice     daily dosing in participants with T2DM. The primary hypothesis is that following multiple     daily dose administration to achieve steady-state drug concentrations, 100-mg sitagliptin     will demonstrate greater DPP-4 inhibition at 24-hours after the final dose compared to 5-mg     saxagliptin and 50-mg vildagliptin (once daily administration) in participants with T2DM.     Each participant will receive all 5 treatments in randomized order. There will be a washout     interval of at least 10 days between the last dose of study drug in one period and the first     dose of study drug in the following period.   "
130108|NCT01582009|"     RATIONALE: Panobinostat and everolimus may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth or by blocking blood flow to the tumor.      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving     panobinostat together with everolimus and to see how well they work in treating patients with     metastatic or unresectable renal cell cancer that does not respond to treatment with     sunitinib malate or sorafenib tosylate   "
130070|NCT01582516|"     In the Netherlands a 2 center investigator-driven phase I/II clinical trial is initiated in     June 2010 testing the oncolytic adenovirus Delta24-RGD to treat glioblastoma patients. The     virus is administrated using convection-enhanced delivery by 4 catheters as delivery     technique, targeting solid tumor as well as infiltrated tumor cells within the peri-tumoral     brain. Patients will be enrolled in cohorts of 3 per dose-level. The dose levels to be     explored are: 10^7, 10^8, 10^9, 10^10, 3*10^10 and 10^11 viral particles (vp). Once the MTD     has been determined, or the study has reached the highest dose cohort, a further 6 or 9     patients will be enrolled at the MTD and evaluated for safety and preliminary signs of     efficacy, such that in total at least 12 patients have received the MTD.      The primary objective is to determine the safety and tolerability of Delta-24-RGD     administered by CED to the tumor and the surrounding infiltrated brain in patients with     recurrent GBM. Secondary objectives are to determine the Progression Free Survival (PFS),     Overall Survival (OS), and tumor response rate in patients with recurring tumors amenable for     surgical resection and treated at the MTD.      Cerebrospinal fluid as well as brain interstitial fluid by microdialysis next to the     routinely collected samples of blood at various timepoints before, during and after virus     infusion. Various neurodegenerative biomarkers as well as markers of immune response will be     assessed in these samples.      Furthermore extensive sampling and PCR analyses will be performed to evaluate distribution     and shedding of the virus.   "
130071|NCT01582503|"     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety     of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately     controlled on chronic therapy with high dose inhaled corticosteroids and a second controller     medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of     either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual     asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with     a 48-week follow-up.   "
130072|NCT01582490|"     This is a Phase 4, prospective, open-label, non-randomized, sequential study with two     treatment groups differing only in the technique used for EXPAREL administration     (instillation or infiltration).   "
130073|NCT01582477|"     The purpose of the study is to assess the safety and efficacy of EXPAREL when administered     via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical     analgesia in men undergoing robot-assisted laparoscopic prostatectomy.   "
130074|NCT01582464|"     The goal of this phase of the project is to identify the elements of the Theory of Planned     Behavior (TPB) that should be targeted to provide the most influence on older adults'     behavior (or other stakeholders) to purchase and wear protective headwear. The investigators     also intend to determine the format of communication (social marketing/academic detailing)     that is most influential for different key stakeholder groups. The TPB has been useful in     understanding behavior change related to exercise and adaptive equipment use (such as grab     bars, canes, hip protectors); in understanding how a person's attitudes, subjective/social     norms and perceived behavioral control inform the development of intention that leads to     behavior change.   "
130075|NCT01582451|"     The purpose of this study is to compare LY2605541 and insulin glargine using the following     measures after participants have been treated for 26 weeks:        -  Change in participants' overall blood sugar control        -  The number of night time low blood sugar episodes        -  The number of participants that reach blood sugar targets without low blood sugar          episodes at night        -  The total number of low blood sugar episodes reported   "
130076|NCT01582438|"     The purpose of this study is to provide sildenafil therapy to subjects who have completed the     A1481156 study for the treatment of Pulmonary Arterial Hypertension (PAH) in India and are     judged by the Investigator to derive clinical benefit from continued treatment with     sildenafil citrate. Sildenafil citrate will be supplied for the treatment of Pulmonary     Arterial Hypertension (PAH) until the subject continues to derive benefits from the     treatment. The treating physicians (and the sponsor) will be responsible for reporting     serious adverse events.   "
130077|NCT01582425|"     The primary purpose of this study is to assess the effect of multiple doses of isavuconazole     on the pharmacokinetics (PK) of methadone after single dose administration. The secondary     purpose is to assess the safety and tolerability of isavuconazole alone and in combination     with methadone.   "
130078|NCT01582412|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of a single dose of digoxin in healthy adult subjects.   "
130079|NCT01582399|"     The objective of this study is to assess levels of ASKP1240 in the blood after a single dose     given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how     the drug behaves inside the body and how it is eliminated from the body by looking at the     pharmacokinetics of ASP1240.      In addition, the study will determine the effects of ASKP1240 on the body by looking at its     pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as     SC injection.   "
130080|NCT01582373|"     The current pilot study aims to assess the feasibility and preliminary efficacy of a novel,     12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners.   "
130081|NCT01582360|"     The main purpose of the study is to examine if changes in pharmacokinetics of important     antiinfectives in Critically Ill patients in need of continuous renal replacement therapy     (CRRT), causes inadequate concentrations in plasma.      The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of     filter, filter lifetime etc.      Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in     critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives     may contribute to increased mortality in this group.   "
130082|NCT01582347|"     This study is designed to determine if opioid dependent subjects who are already receiving     Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will     continue their pre-study prescribed dosage of Subutex and/or Suboxone   "
130083|NCT01582334|"     This is an Argentinian, Multicentre, Observational Study to evaluate Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via     easypod™.   "
130086|NCT01582295|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational drug. Phase I studies also try to define the appropriate dose of the     investigational drug to use for further studies. Investigational means that the drug is     still being studied and that research doctors are trying to find out more about it. It also     means the FDA has not approved the drug for your type of cancer.      Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug     cabozantinib works by inhibiting several different proteins which are believed to be involved     in multiple myeloma growth, its ability to spread, and its ability to form new blood vessels.     This drug has been used in other research studies and information from those other research     studies suggests that this drug may help to slow or stop disease growth to bones and prevent     cancer growth.      In this research study, we are looking to see how effective cabozantanib is in slowing or     stopping disease growth to the bones as well as preventing your cancer from worsening. We are     also looking for the highest dose of cabozantinib that can be given safely to patients who     have multiple myeloma with bone disease.   "
130087|NCT01582282|"     A double-blind, randomized, placebo-controlled, multi-dose clinical study consisting of 2     phases; 1) an 8-week lead-in period during which patients followed a diet judged to be within     the acceptable guidelines of the ADA, and 2) a 12-week treatment period, at the beginning of     which, Subjects are randomly assigned to 1 of the 3 treatment groups: placebo, 3.4 g psyllium     BID for a total of 6.8 g/day (10.4g Metamucil) or 6.8g psyllium BID for a total of 13.6 g/day     (20.8g Metamucil). For 12 weeks, Subjects took Metamucil or the fiber-free placebo BID, just     prior to breakfast and dinner.      Patients visited the clinic 10 times during the 20-week period at Screening, Weeks -8, -6,     -4, 0, Day 3, and Weeks 2, 4, 8 and 12, fasting at least 12 hours prior to each visit where a     blood sample was taken (all visits except Week -6 and Day 3) for analysis of fasting serum     glucose and lipid levels, and HbA1c. Clinical chemistry, hematology and urinalysis were done     at Weeks -8, 0 and 12. The completed 7-day food diaries were reviewed by the study dietician     at each visit and discussed with the patient to ensure compliance with the recommended diet     and the patients' body weights were recorded   "
130088|NCT01582269|"     The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299     plus lomustine therapy or lomustine plus placebo can help participants with brain cancer   "
130089|NCT01582256|"     The study aims to investigate whether neuropsychological function (particularly cognitive     flexibility and executive function), functional (assessed by resting functional MRI, rfMRI)     and structural connectivity (assessed by DSI), and electrophysiological function (assessed by     event-related potential [ERP]: mismatch negativity, MMN and P50) can be effective cognitive     endophenotypes (biomarkers) for Autism spectrum disorders (ASD).   "
130090|NCT01582243|"     This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2     diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment   "
130091|NCT01582230|"     The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid     add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus     inadequately controlled on insulin with or without metformin treatment.   "
130092|NCT01582217|"     The purpose of this study is to assess the the 1-year rates of ischemic and bleeding     complications in patients whose dual antiplatelet therapy regimen post-PCI has been     determined with the use of a clinical algorithm that includes both clinical risks and     platelet reactivity while on chronic clopidogrel therapy.   "
130093|NCT01582204|"     Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors.     Sometimes, even when a drug is working, it can take several months before the effects are     seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called     124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular CT     scan.      Research has shown that certain proteins in the blood, called antibodies, can attach     themselves to cancer cells without binding to normal cells. In this study, an antibody is     used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive     isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body, 124I     shows up on the PET scan.   "
130094|NCT01582191|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of vandetanib and everolimus that can be given to patients with advanced cancer.     The effects of the study drugs at different dose levels and the safety of the study drugs     will also be studied.      Vandetanib and everolimus are both designed to harm cancer cells, stopping their growth. This     may stop or slow the growth or spread of cancer cells.   "
130095|NCT01582178|"     Water immersion insertion has been documented to decrease procedure-related discomfort during     colonoscopy. There was used warm water infusion for colonoscope insertion in most of the     water immersion colonoscopy trials.      The investigators have been using room temperature water (20-24°C) for water immersion and     the investigators did not notice any drawback of it. In our opinion, it is simpler and     cheaper option for water immersion colonoscopy and proof of its efficacy and safety could     support the use of water immersion technique in routine practice.      The primary endpoint is cecal intubation time and the investigators suppose that the use of     warm water infusion does not shorten it significantly. Patient comfort during colonoscope     insertion, water consumption, length of the scope while reaching the cecum, need for external     compression, need for positioning of the patient and endoscopist´s difficulty with     colonoscopy will be also assessed.   "
130096|NCT01582165|"     Female patients presenting with persistent chest pain despite no obstructive coronary artery     disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as     20% of women with chest pain and minimal angiographic CAD have evidence of myocardial     ischemia, suggesting impaired coronary microcirculation. The index of microvascular     resistance (IMR) is a method for indirectly investigating microvascular function in the     cardiac catheterization laboratory.      66 female patients, age 30-70 years, with chest pain and normal or near normal coronary     angiograms will be included. After coronary physiologic evaluation, patients will be     randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for     altogether 6 months.      The investigators hypothesize that:        1. A substantial number of women with chest pain and normal or minimal pathology on          angiograms have microvascular dysfunction defined by a raised IMR.        2. Statins, based on its pleiotropic action will improve endothelial function and thereby          IMR.   "
130097|NCT01582152|"     The goal of Part I of this clinical research study is to find the highest tolerable dose of     TPI 287 that can be given with bevacizumab to patients with glioblastoma. The goal of Part II     is to learn if TPI 287 when given with bevacizumab can help to control glioblastoma better     than when bevacizumab is given alone. The safety of the drug combination will also be     studied.      TPI 287 is similar to a type of chemotherapy drug called a taxane and is designed to block a     protein (tubulin) that helps the cancer cells divide. By blocking the tubulin, the drug may     be able to cause the cancer cells to shrink or stop growing.      Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the     growth of blood vessels.   "
130098|NCT01582139|"     The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell     Phone + Closed Loop Control) can successfully control blood sugar in people with type 1     diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be     studying to see if information about heart rate can help the AP Platform reduce hypoglycemia     related to exercise.   "
130099|NCT01582126|"     People with multiple sclerosis (MS) often have affected balance capacity and an increased     risk for falls. A risk factor for falls are activities requiring dual attention. Another     factor leading to reduced balance capacity is trunk stability, and decreased trunk stability     has been seen in people with MS compared to healthy controls. Earlier studies using core     stability exercises have shown positive effects on balance, compared to no training. In     Sweden, physical therapy for people with MS has often included group training. However,     evidence for this intervention is scarce. The aim of this study is therefore to investigate     balance training in group. The balance training includes core stability exercises and dual     attention activities. A multi-centre study is planned with a waiting-list design.     Participants are randomised to either exercise group with early start or with late start. The     group balance training includes training 60 minutes 2 times per week for 7 weeks.   "
130100|NCT01582113|"     To determine the functional effects of Citicoline, a natural supplement, when administered     for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The     investigators hypothesize that citicoline will provide cognitive benefits to this population     after 28 days of supplementation.   "
130101|NCT01582100|"     Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently     encountered in the health care setting. It affects roughly 40% of Americans monthly and 10%     weekly. Of those with GERD, there exists a cohort that experience nausea with or without     vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment     options are limited and these symptoms may substantially alter their quality of life. New and     novel therapies emerging include neuromodulation devices that may affect the central pathways     leading to these symptoms. Of these, the Reletex band has been tested and proven efficacious     in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery,     in addition to standard anti-nausea medications. The investigators propose that through a     similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce     GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of     lives in this patient population.   "
130102|NCT01582087|"     The purpose of this study is to understand mechanisms associated with the development of coma     during hepatic failure. As of today, those mechanisms are not understood and it is difficult     to intervene and prevent coma development which is often associated with mortality.     Understanding the mechanism involved, may allow us to prevent coma and develop new therapies     to treat this disease.   "
130103|NCT01582074|"     Background:      - Studies have shown that changes in breast density (the amount of white area on a woman's     mammogram) may be related to changes in breast cancer risk. Currently, there is no ideal way     to measure breast density repeatedly over time. Researchers want to test whether ultrasound     tomography scans can show changes in breast density. To examine these changes, healthy     volunteers with no history of breast cancer and women who are taking tamoxifen will have     ultrasound tomography scans.      Objectives:      - To test whether ultrasound tomography scans can show changes in breast density related to     tamoxifen exposure.      Eligibility:      - Women between 30 and 70 years of age who are (a) taking tamoxifen or (b) healthy volunteers     who have never had breast cancer.      Design:        -  All participants will have a screening visit. Healthy volunteers will have one          additional study visit; women taking tamoxifen will have three additional study visits.        -  All participants will be screened with a physical exam and medical history. They will          also give blood and saliva samples. This visit will also include an initial ultrasound          tomography breast scan.        -  For the healthy volunteers:        -  At the study visit (12 months after the screening visit), participants will have a short          interview and be weighed. They will also have an ultrasound tomography breast scan and          provide a blood sample.        -  For the women taking tamoxifen:        -  At the second and third visits (1 to 3 months and 3 to 6 months after starting          tamoxifen), participants will have a short interview. They will also be weighed and have          an ultrasound tomography breast scan.        -  At the fourth visit (12 months after starting tamoxifen), participants will have a short          interview, weight measurement, and the ultrasound tomography breast scan, and will also          provide a blood sample.        -  All participants may be followed for up to 5 years after their final study visit.   "
130104|NCT01582061|"     This study will document the safety and efficacy of pasireotide s.c. in patients with     Cushing's disease.   "
130105|NCT01582048|"     Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus,     mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a     reduced intensity conditioning regimen with fludarabine/treosulfan   "
130106|NCT01582035|"     The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug     is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055 given     in combination with telaprevir in HCV infected patients. TMC647055 is being investigated for     the treatment of hepatitis C infection. Telaprevir has recently been approved in the USA and     in Europe for the treatment of chronic hepatitis C infected patients.   "
131040|NCT01569802|"     The primary aim of this study is to measure, document and compare recall rates of     two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D     mammography in a screening population. This study will compare recall rates for both     non-cancer and cancer cases.   "
130107|NCT01582022|"     Research Methodology:      It will be a prospective, randomized, placebo-controlled, single-blind, intra-individual     study in which one tonsillar fossa will be the tested side, and the other fossa will be the     control. And the tested side will be packed with bupivacaine for five minutes. In the other     hand, the controlled side will be packed for five minutes with gauze soaked in normal saline.     The selection of the tested side and controlled side will be randomized based on the last     digit in the medical record number (i.e. if the last digit is even then the tested side is     the right and if the last digit is odd then the tested side is the left). Pain evaluation     will be by visual analog scale and it will be in frequency of 2, 4, 6, 8, 12, 24 hours     post-op.   "
130117|NCT01581892|"     The aim of the study is to determine the safety and feasibility of autologous mononuclear     stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.   "
130109|NCT01581996|"     Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are     very common complications of people with advanced chronic kidney disease (i.e., stage 5 CKD),     including chronic dialysis patients, and are associated with severe morbidity and increased     mortality. Despite attempts to control serum phosphorus with dietary phosphorus restriction     and the use of medicines that bind phosphorus in the gastrointestinal tract so that the     phosphorus cannot be absorbed into the body( also called phosphate binders), chronic dialysis     patients frequently remain hyperphosphatemic, particularly at the time when they commence     each of their regular dialysis treatments.      Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal     phosphate binder that appears to have the advantages of being safe, well tolerated and     effective at binding phosphate. There are limited data on the magnitude of binding of     phosphorus by Fosrenol in the human gastrointestinal tract of patients with chronic kidney     disease.      The specific aims for this proposal are as follows:        1. To quantify, under precisely controlled metabolic balance conditions, the increase in          fecal excretion of dietary phosphorus that occurs when patients undergoing chronic          peritoneal dialysis (CPD) ingest Fosrenol (lanthanum carbonate).        2. To examine a dose response relationship between Fosrenol treatment and fecal phosphorus          excretion. The investigators will examine in CPD patients ingesting a constant          phosphorus intake, how much additional phosphorus is excreted in the feces at three          different dose levels of Fosrenol, 1.5, 3.0, and 4.5 g/day.        3. To examine how increased fecal phosphorus losses and more negative phosphorus balance          caused by Fosrenol intake affects serum phosphorus and such hormonal regulators of          phosphorus metabolism as serum parathyroid hormone (PTH), fibroblast growth factor-23,          25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and          fetuin-A.        4. To assess whether there is any effect of Fosrenol and increased intestinal phosphate          binding on protein-nitrogen balance.   "
130110|NCT01581983|"     The purpose of this study is to assess feasibility of an internet and individual format of     mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression     symptoms   "
130111|NCT01581970|"     This is a feasibility study to assess the effectiveness of cetuximab when administered with     low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and     neck who have progressed on first line chemotherapy other than a cetuximab containing regimen     will be treated with standard of care weekly cetuximab and twice daily low dose oral     cyclophosphamide for 12 weeks.   "
130112|NCT01581957|"     Specifically designed enteral formulations may improve the gastrointestinal tolerance during     early enteral nutrition in the critically ill patient.      This pilot trial will permit testing the design of the full-scale study providing valuable     data on the expected effect of the formulation, the variability, thus helping to better     estimate the required sample size.   "
130113|NCT01581944|"     Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are     benign growth in the womb or uterus and in order to preserve the fertility of women they,     require an operation called myomectomy or shelling out of the fibroid. This procedure can be     associated with large blood loss.      In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to     the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current     gynaecological practice to treat women with heavy periods.      In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin     agonist prior to their operation and no treatment. The intraoperative blood loss was     measured. The study hypothesis: To determine whether administration of gonadotropin releasing     hormone agonist prior to myomectomy reduces intraoperative blood loss.   "
130114|NCT01581931|"     To establish bioequivalence (BE) under fed conditions between metformin in     linagliptin/metformin fixed dose combination tablet and metformin reference product     administered in free combination togther with linagliptin   "
130115|NCT01581918|"     Nausea and vomiting are common problems for cancer patients. Half of them will experience     these symptoms during the course of their disease, either because of the cancer itself or     because of their treatment1. They are ranked by patients as two of the worst adverse effects     of cancer chemotherapy and cause a negative impact on patient's functional, emotional, social     and nutritional status and quality of life2,3.      Nowadays, a wide variety of antiemetic agents are available for the prevention and treatment     of CINV. In this scenario, three classes play a critical role: Selective 5-HT3-receptor     antagonists - approved for clinical practice in early 1990s, revolutionized the management of     CINV representing the most effective agents in the treatment of acute emesis -,     Corticosteroids - with unknown mechanism of action, effective when administered as single     agents in patients receiving chemotherapy of low emetic potential but are most beneficial     when used in combination with other antiemetic agents, potentiating their anti-emetic     efficacy in both acute and delayed symptoms - and neurokinin 1 receptor antagonist - also     effective against both acute and delayed emesis, but restricted utility in daily clinical     practice because of its high cost.   "
130138|NCT01581619|"     Standard therapy for patients with early stage breast cancer consists of surgery to remove     the cancer followed by radiation therapy. One question regarding radiation therapy for early     stage breast cancer is whether the entire breast needs to be radiated or only a more limited     area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the     whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of     the breast where the cancer was removed (called the tumor bed).      The investigators hope the option of PBI will reduce side effects from radiation therapy and     shorten the radiation treatment process when compared to WBI, since only part of the breast     is being treated. The investigators also hope that this will make such treatment more     convenient for breast cancer patients.      The purpose of the study is to evaluate the the safety of external-beam PBI in selected early     breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators     will also evaluate the local control and the cosmetic results.   "
130116|NCT01581905|"     Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12%     are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine     leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic     hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic     hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and     shorter recovery times than abdominal hysterectomy. The literature has also shown the     complication rates for laparoscopic cases are similar to open procedures in the hands of an     experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists     Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to     abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or     feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic     hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less     blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG     for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally.     Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles     of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to     decrease the learning curve and increase the availability of minimally invasive surgery to     patients. A current review of the literature reveals no randomized trials evaluating the     efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic     hysterectomy. The investigator's aim is to address this void.      The primary objective of this study is to determine whether Robot-Assisted Laparoscopic     Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to     operative time, blood loss, and hospital stay. The investigator's secondary objective was to     assess the cost, morbidity, and mortality of each procedure.   "
130121|NCT01581840|"     Treatment is based on radiochemotherapy for locally advanced tumours. The objective of     treatment is to provide a cure without resorting to abdominoperineal amputation, while     preserving sphincter function.      The prognosis is mainly related to tumour size and lymph node invasion. The large majority of     patients do not show any spread remote from the tumour at the time of diagnosis (2).      Recurrences are mainly of a local/regional nature and require abdominoperineal amputation.     This type of intervention is not always possible or complete, which then gives rise to the     particularly distressing risk of local progression, with survival at 3 years of approximately     30% (3).      It is therefore very important to achieve a complete and permanent tumour response from     initial treatment with radiochemotherapy.      Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in     ENT cancer was able to increase recurrence-free survival and overall survival in these     patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR     antibodies in epidermoid cancer of the anus.   "
130122|NCT01581827|"     Heart failure (when the heart does not pump as well as it used to) is a medical condition     which reduces the quality of life for the sufferers. Approximately 10% of people in western     societies aged over 75 develop heart failure. There has been a shift towards prevention of     this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal     proBNP) will prove to be useful indicators of those at greatest risk. The current study     therefore plans to follow up the 3500 participants at risk of heart failure from the original     SCREEN-HF study.      Participants who are willing to participate will be contacted annually. They will undergo a     short physical exam, will be asked to complete a Quality of Life questionnaire and will have     a blood sample taken. At the end of the study participants will also have an ECG and an     echocardiogram.   "
130123|NCT01581814|"     To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin     alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS     patients   "
130124|NCT01581801|"     Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2     obesity associated with complications. Among the bariatric surgical procedures, roux-en-y     gastric bypass (RYGB) was shown to account for 41% of all bariatric operations at least in     the United Sates. Sleeve gastrectomy (SG), that was conceived as the first step before     performing a RYGB or a biliopancreatic diversion with duodenal switch in patients who were     super-obese, has recently emerged as a new restrictive bariatric procedure.      Reactive hypoglycemia is a late complication affecting up to 72% of RYGB patients although it     seems to occur also after SG, in about 3% of the cases. However, until now no prospective     studies have investigated the incidence of hypoglycemia after RYGB nor randomized studies     have been undertaken to compare the effect of SG to that of RYGB in terms of incidence of     hypoglycemic episodes.      The primary aim of the present study is to conduct a 1-year randomized trial to compare the     incidence of hypoglycemia after RYGB or SG.   "
130125|NCT01581788|"     The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER     Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in     healthy, adult, human subjects, under fed conditions and to monitor adverse events and ensure     the safety of subjects.   "
130126|NCT01581775|"     The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER     Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in     healthy, adult, human subjects, under fasting conditions and to monitor adverse events and     ensure the safety of subjects.   "
130146|NCT01581515|"     The purpose of this study is to compare the degree of stent malapposition on an immediate     optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure     OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with     the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience     PRIME® stents.   "
130147|NCT01581502|"     The purpose of this study is to determine choice of anticoagulant therapy during acute and     chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke     recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.   "
131068|NCT01569438|"     The purpose of this study is to assess the efficacy of a single dose level of gefapixant     (AF-219/MK-7264) in female subjects with moderate to severe pain associated with interstitial     cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.   "
130127|NCT01581762|"     Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an important investigation     tool to obtain tissue for diagnosis. Nowadays, the performance of EUS-FNA varies with     accuracy rates ranging from 60% - 100%. Needles with different diameters have been explored     to retrieve tissue specimens. The diagnostic yields, successful rates and safety profiles are     similar. It has been suggested that although thinner needles provide less cellular material     than do larger needles, the specimens from the former are less contaminated by blood, and     thus easier to interpret. In addition, thinner needles may be easier to use because of     greater flexibility, particularly for locations requiring important scope bending. As a     result, a new 22G FNA needle has been designed in order to improve the tissue-sampling rate     (ECHO-HD-22-C, Cook Endoscopy, USA). There is a reverse bevel at the tip of the new needle     with promotes collection of core sample by shearing material from target lesion during     retrograde movement of the needle in the lesion. The feasibility and safety of this newly     design EUS-FNA needle have been demonstrated in a recent multicenter, pooled, cohort study     using the 19G version. Successful puncture was technically feasible in 98.2% of cases and the     overall accuracy of 92.9%. There were no complications related to the technique.      The aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy rate     of EUS-FNA between the uses of the convention and newly designed 22-gauge needles.   "
130128|NCT01581749|"     The primary safety purpose of this study is to estimate the rates of immediate and long-term     high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years     after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate     cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free     survival rates with TrueBeam to 5 year biochemical diseases free survival rates with     dose-escalated external beam radiation therapy.   "
130129|NCT01581736|"     This protocol is being conducted to determine the mechanisms responsible for insulin     resistance, obesity and type 2 diabetes.   "
130130|NCT01581723|"     Bladder cancer is a common urological malignant disease. Patients with bladder cancer will     first be managed with transurethral resection (TUR) of bladder tumor. For many years,     monopolar transurethral resection of bladder tumor (TURP) has been the gold standard for     treatment. However, complications including bleeding, bladder perforation and inadequate     sampling of deep tumor biopsy remain the major concerns. Recently published papers suggested     that the newer bipolar TUR technology has similar surgical outcomes but less complications     comparing with monopolar TUR. In this study, investigators will investigate the benefit of     new technology as compared with conventional monopolar resection on tumor clearance,     complication and recurrence rates.   "
130131|NCT01581710|"     Primary hypothesis: Montelukast will decrease bronchial hyperresponsiveness in subjects with     persistent allergic rhinitis when compared with those treated with placebo in a double-     blind, placebo-controlled, cross-over 5-week randomized trial.      Secondary hypothesis: There will be a significant correlation between allergic rhinitis     severity and bronchial hyperresponsiveness severity and baseline lung function measures.      Tertiary hypothesis: Subjects who respond well to montelukast will have particular     characteristics of allergic rhinitis when compared with those who do not respond to     montelukast.   "
130132|NCT01581697|"     Atherosclerosis is the leading cause of death and disability in adults. However,     investigations suggest that the basic pathology of heart disease as more severe myocardial     infarction which usually reach mainly middle-aged or above, starts from childhood.     Hypercholesterolemia is one of the most important risk factors for atherosclerosis in adults     and children, is associated with early deposition of lipids in the aorta and coronary     arteries.      Among other recommendations for prevention and treatment of heart disease and risk factors,     is the recommendation to encourage the intake of soluble fiber. The oats, a major source of     soluble fiber, has been recognized as a potential component of the diet to lower blood     cholesterol levels, this effect is attributed mainly to the beta-glucan, a type of soluble     fiber present in large quantities in oats. In 1997 the Food and Drug Administration admitted     that the oat bran, oat flakes and oatmeal may have beneficial effects for health with the     recommendation of daily intake of 3g of beta-glucan from oats and a food that brings a claim     for promotion health, must provide, without enrichment, at least 1 gram of beta-glucan per     serving.      The objective of this project will be compared by randomized clinical trial, the impact of     intake of oats, for 8 weeks in the lipid profile of children and adolescents with     dyslipidemia.      Will be included in the study 120 volunteers aged between 5 and 16 years who are in     nutritional monitoring for at least 1 month. The subjects will be randomly divided into 2     groups, with a control group and another intervention will receive 3 tablespoons of soup     filled with oat bran, which corresponds to 3g of beta-glucan, along with breakfast, lunch and     dinner. Patients will be monitored with consultations on the 2nd, 4th and 8th weeks of     treatment. Blood sample will be performed, to obtain the lipid profile of patients, at the     beginning and end of the study. To compare the groups are used Student's t and squared chi.     The alpha of 0.05 is considered critical. The program will be used Statistical Package for     the Social Sciences (SPSS) version 15.0.      It is expected a decrease in serum levels of total cholesterol and LDL-c. Thus, living habits     and healthy alternatives to prevent these risk factors should be done since childhood,     especially in children who already have cholesterol levels of change.   "
130133|NCT01581684|"     The primary objective of the current study is to investigate the safety, tolerability and     pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of     single rising doses.      The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19     (Cytochrome P450) genotyped extensive metabolisers (EM).      Another objective is to compare the safety and pharmacokinetic profiles between two different     groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)   "
130134|NCT01581671|"     The purpose of this study is to assess the non-invasive, Peripheral Arterial Tonometry (PAT)     testing as another way of predicting potential coronary artery blockages in the heart.   "
130135|NCT01581658|"     The objective of this study is to assess the effect of the different degrees of renal     impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral     administration of high dose BI10773 as a single dose in Japanese patients with type 2     diabetes mellitus.   "
130136|NCT01581645|"     Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with     Parkinson's disease and Parkinsonism.   "
130137|NCT01581632|"     The investigators hypothesis is that local activation of the endogenous Lp-PLA2 plays an     integral role in early atherosclerosis, and contributes to the mechanism of coronary     endothelial dysfunction and to the structural and mechanical properties that characterize     plaque vulnerability. Thus, our study will characterize prospectively the correlation between     the functional and structural vascular wall properties, and the activity of the Lp-PLA2     pathway.   "
131147|NCT01568411|"     This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4)     and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg     tablet of TD- 1211 administered orally to fasted subjects.   "
130139|NCT01581606|"     Hypothesis:      The use of teleophthalmology for patient screening will result in more rapid patient access     for treatment. The use of teleophthalmology to monitor patients with wet AMD post-treatment     will result in maintenance of good visual outcomes combined with a reduction in patient     travel and improved patients satisfaction in a cost effective manner.      Objectives :      The Evaluation of Teleophthalmology in AMD project objectives are as follows:        1. To evaluate the efficacy of teleophthalmology in screening patients referred to retina          specialists for suspected wet AMD.        2. To compare the time to treatment/retreatment with this program with that of patient's          entering the system and being followed conventionally to determine the efficacy of          teleophthalmology to provide rapid entry/re-entry into treatment programs.        3. To determine the efficacy of teleophthalmology in monitoring patients with wet AMD post          therapy.        4. To determine the compliance rate for monitoring wet AMD during follow-up utilizing          teleophthalmology.        5. To evaluate the cost effectiveness of teleophthalmology in screening/monitoring wet AMD          patients including direct costs to the OHIP system and indirect costs to the          patient/caregiver.        6. To assess patient satisfaction with teleophthalmology versus standard clinical care in          the monitoring of post-treatment wet AMD.        7. To evaluate teleophthalmology as a tool for communication between community based          Optometrists /Ophthalmologists and Retina Specialists.   "
130140|NCT01581593|"     The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin     solution) is effective in treating Primary Immunodeficiency (PID).   "
130158|NCT01581359|"     The purpose of this study is to determine whether the administration of an analogue of     gonadotropin-releasing hormone (GnRH) during the three months prior to the performing of an     IVF may improve the response to ovarian stimulation, implantation rate and clinical pregnancy     rate in patients with endometriosis/ endometriomas.   "
130141|NCT01581580|"     Background:      - Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like     Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered     device called a neurostimulator (like a pacemaker) that is placed under the skin in the     chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these     areas helps to block the nerve signals that cause abnormal movements. Researchers also want     to record the brain function of people with movement disorders during the surgery.      Objectives:        -  To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.        -  To obtain information on brain and nerve cell function during DBS surgery.      Eligibility:      - People at least 18 years of age who have movement disorders, like Parkinson's disease,     essential tremor, and dystonia.      Design:        -  Researchers will screen patients with physical and neurological exams to decide whether          they can have the surgery. Patients will also have a medical history, blood tests,          imaging studies, and other tests. Before the surgery, participants will practice          movement and memory tests.        -  During surgery, the stimulator will be placed to provide the right amount of stimulation          for the brain. Patients will perform the movement and memory tests that they practiced          earlier.        -  After surgery, participants will recover in the hospital. They will have a followup          visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be          programmed and adjusted over weeks to months to find the best settings.        -  Participants will return for followup visits at 1, 2, and 3 months after surgery.          Researchers will test their movement, memory, and general quality of life. Each visit          will last about 2 hours.   "
130142|NCT01581567|"     Background:      - Information and samples collected from participants in medical research studies can be     useful even after the original study is complete. Researchers can use the information and     samples to learn more about multiple sclerosis or other immune system disorders. They can     also be used for research into other disorders. Researchers would like to get permission to     use samples collected from older studies to launch new lines of research.      Objectives:      - To look at information and samples from earlier National Institutes of Health     Neuroimmunology Branch studies.      Eligibility:      - People who provided samples and medical information for earlier studies.      Design:        -  Researchers will contact people who took part in earlier studies. Researchers will ask          if they can study previously collected data and samples.        -  Data and samples may include physical exam data and psychological test results. Imaging          study results are included. Preserved samples of body fluids and tissues may be studied.          These include blood and urine samples.        -  No new treatment will be provided as part of this research study.   "
130143|NCT01581554|"     Background:      - Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and     cancer of the liver. There is no cure for the infection, but several drugs have been approved     to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term     use. But the drugs have not yet been approved for long-term use because some of them can have     serious side effects. However, stopping treatment too soon can make the infection worse and     may lead to more serious forms of liver disease. Researchers have not been able to determine     a when to stop treatment. They want to study people with chronic hepatitis B infection to     find out the best time to stop treatment and prevent the disease from causing further liver     damage.      Objectives:        -  To study the safety and effectiveness of withdrawing antiviral treatment for chronic          hepatitis B after at least 4 years of treatment.        -  To determine whether stopping long-term antiviral treatment for chronic hepatitis B          makes the infection worse.      Eligibility:      - People who are at least 18 years of age; have been taking antiviral drugs to treat chronic     hepatitis B for at least 4 years; and are being evaluated to stop treatment.      Design:        -  Those in the study will be screened with a physical exam, medical history,          questionnaire, and blood tests. They will remain under the care of their regular doctor          during the study.        -  They will have an abdominal ultrasound to study scarring in the liver, if they have not          had one in the past year.        -  Those without detectable levels of the hepatitis B virus in their blood will stop          antiviral treatment. They will have monthly blood tests for the first 6 months to check          virus levels, and then every 3 months afterward.        -  Those whose blood tests show an increase in virus levels will restart antiviral          treatment as directed by the study doctors and their personal doctor.        -  All those in the study will be monitored until the end of the study.   "
130144|NCT01581541|"     Background:      - PU-H71 is an experimental drug used to treat cancer. It works by blocking a protein in     tumors. When this protein is blocked, it affects other proteins inside the cell that cancers     need to grow. Researchers want to study whether PU-H71 is a safe and effective way to treat     solid tumors and non-Hodgkin's lymphoma.      Objectives:      - To evaluate the safety and effectiveness of PU-H71 in solid tumors and non-Hodgkin's     lymphoma that have not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have solid tumors or non-Hodgkin s lymphoma that     have not responded to standard treatments.      Design:        -  Patients will be screened with a physical exam, medical history, blood tests, and          imaging studies.        -  Patients will receive PU-H71 as a 1-hour dose on days 1 and 8 of a 21-day cycle of          treatment. The first treatment cycle will be done in the hospital so that patients can          be monitored. The next treatment cycles will be done on an outpatient basis.        -  Patients will have blood and urine tests and eye exams.        -  Patients will provide tumor samples for study.        -  Patients will have imaging studies to monitor tumor response to treatment.        -  Patients will continue to take PU-H71 for as long as side effects remain tolerable and          their tumor or lymphoma does not worsen. Study researchers may adjust the dose if          needed.   "
130145|NCT01581528|"     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in     the laboratory may help doctors identify learn more about biomarkers related to cancer. It     may also help doctors to find better ways to treat cancer.      PURPOSE: This research studies samples from patients with T-cell acute lymphoblastic leukemia     (T-ALL).   "
131148|NCT01568398|"     The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in     participants with a history of gastric or duodenal ulcer requiring long-term low-dose aspirin     therapy will be investigated.   "
130148|NCT01581489|"     Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by     increasing the infant's iron endowment at birth. Compared to early clamping, a delay in     clamping in clamping of around 2-3 min provides an additional 25-40 mL of blood per kg of     bodyweight to the newborn infant.      The results of previous intervention studies on delayed clamping are mixed, and few have     followed the infants beyond the perinatal period. All longer follow up studies have been     performed in low income countries except for the investigators earlier study, showing less     iron deficiency and improved iron stores after delayed cord clamping at 4 months of age.      The main objective of the current study is to assess whether the time of cord clamping     affects neurodevelopment at 4 years of age in a large sample of full-term, Swedish infants.     The investigators hypothesis is that as delayed cord clamping improves iron stores at 4     months, this could affect the child's development positively.   "
130149|NCT01581476|"     The purpose of this study is to determine whether use of blood pressure lowering drugs,     Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs     (statins) may have a place in the treatment of adolescents with diabetes and can help reduce     serious long-term health problems in this population.   "
130159|NCT01581346|"     In the course of their disease patients with Non small cell lung cancer (NSCLC) often     experience impaired psychological and physical functioning resulting in a reduced quality of     life (QoL). The aim of the study is to explore the feasibility and the effects of an eight     weeks combined muscle strength and endurance training on physical capacity and QoL.   "
130150|NCT01581463|"     Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10     Million in the United States and 80 Million patients world-wide are hypothyroid, usually the     result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from     low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid hormone     production by the thyroid gland. Every tissue in the body is a thyroid hormone target and     hypothyroid symptoms can be debilitating.      BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt     utilized as the active ingredient in currently marketed products.      The current gold standard for treatment of hypothyroidism are products containing     Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3     by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally     not euthyroid as measured by clinical presentation, a condition hypothesized to result from     low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of     conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the     patient.      BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented     formulation and granulation procedure that solves multiple clinical and stability problems     associated with T3-based products. Thus, BCT303 is designed to have:        1. Increased shelf stability to ensure the maintenance of claimed dosage.        2. A sustained-release profile to minimize side effects associated with spikes in serum T3          levels.        3. Uniformity of dose between production batches and between tablets.   "
130151|NCT01581450|"     Evaluation of the effects of 35%/15%/50% N2O/N2/O2 mixtures on the area of hyperalgesia     induced by remifentanil in the CCES (Continuous Cutaneous Electrical Stimulation) model in 20     healthy volunteers.      The duration of participation for each volunteer is expected to be around 9 weeks with the     performance of 4 experimental session 2 weeks apart.      The selection visit will last half a day; each experimental session will last half a day; the     study end will last 2 hours maximum.   "
130152|NCT01581437|"     The 64 pole basket catheter used for the mapping procedure will be defined atypical sites     which sustain atrial fibrillation. The ablation through the driver will lead to more rapid     ablation of the atrial fibrillation.   "
130153|NCT01581424|"     The investigators will perform a study with two major components. The first is a natural     history study of untreated Fabry patients. This study component will detail kidney     microscopic structural changes in Fabry patients before starting enzyme replacement therapy     and will correlate these changes with kidney function, including glomerular filtration rate     and urinary albumin excretion rate. The investigators will perform studies on samples     obtained at baseline, or before enzyme replacement therapy is initiated. The goal of our     study is to find kidney microscopic changes in the biopsies that are associated with kidney     disfunction. Our hypotheses for this study are:        1. Much of the natural history of Fabry renal structural changes will occur without          detectable renal functional alterations.        2. Structural changes associated with the initial onset of proteinuria and those associated          with the subsequent progressive loss of filtration function will differ and will be best          described by non-linear models.        3. There will be sufficient precision of Fabry renal structural-functional relationships to          support renal structure as an acceptable clinical trial surrogate endpoint for later          renal functional deterioration.      The second component examines the effects of age and gender at start of enzyme replacement     therapy (ERT), as well as dosage levels of ERT on the renal cellular clearance of GL3 from     Fabry patients by comparing baseline to follow-up kidney biopsies performed 5, 11, and 60     months later, with all comparisons matched for ERT treatment duration. Our hypotheses for     this component of the study are as follows:        1. Enzyme Replacement Therapy(ERT) instituted at younger ages is more effective in reducing          podocytes(PC),distal tubular cells(DTC),and arterial smooth muscle cells (ASMC)GL-3 than          in older Fabry patients.        2. Earlier institution of ERT will stabilize PC numbers while later ERT institution,          especially in proteinuric adults, may not prevent progressive decline in PC numbers and          associated glomerular sclerosis, tubulointerstitial injury, and GFR loss.        3. Whereas lower ERT dose may effectively clear GL-3 from endothelial and mesangial cells,          it will be less effective in clearing GL-3 from PC and also from DTC and ASMC.        4. Affected cells will be cleared of GL-3 equivalently in females and males.   "
130154|NCT01581411|"     1. Study hypothesis: Injection of t-PA, a thrombolytic drug (clot busting medicine)into the          ophthalmic artery (the blood vessel feeding the eye), in patients with recent severe          central retinal vein occlusion, may reopen the central retinal vein and improve retinal          blood flow, which may in turn improve visual acuity and prevent the long-term          complications of the disease.        2. Experimental intervention: An outpatient procedure during which the ophthalmic artery is          selective catheterized (with a small plastic tube called a microcatheter introduced from          the artery of the leg) and infused with t-PA during two hours.   "
130155|NCT01581398|"     The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b     (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of     180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study     will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on     the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be     enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group     or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily     Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be     enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group     or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily     Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks     after the end of therapy.   "
131149|NCT01568385|"     The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in     participants with a history of gastric or duodenal ulcer requiring long-term NSAID therapy     will be investigated.   "
130157|NCT01581372|"     Background:      Cardiovascular disease (CVD) is the cause of one-third of all deaths in Canada. One important     risk factor for CVD is dyslipidemia. The Canadian Health Measures survey, which was conducted     from 2007-2009, found that roughly 36% of Canadians had unhealthy levels of LDL. Despite     strong evidence and clear practice guidelines for the management of this risk factor, it     remains poorly treated.      Pharmacists are front-line primary care professionals who see patients at risk for     cardiovascular disease more frequently than other healthcare professionals. As such,     pharmacists have the opportunity to systematically and proactively identify patients with     undertreated dyslipidemia, as one public health approach to chronic disease management.      The objective of this study is to evaluate the effect of enhanced pharmacist care (i.e.,     participant identification, assessment, care plan development, education/counseling,     prescribing/titration of lipid-lowering medications and close follow-up) on the proportion of     participants achieving target LDL-cholesterol levels.      Hypothesis: Enhanced pharmacist care will result in a more significant decrease in LDL-c     levels, than that observed in the usual care patients.      Design:      This is a randomized controlled trial of enhanced pharmacist care. The study will be     conducted in twelve community pharmacies in Alberta, including several Safeway Pharmacies.     The participant population will be composed of adults with uncontrolled dyslipidemia as     defined by the 2009 Canadian Dyslipidemia Guidelines. The primary intervention will be     pharmacist directed dyslipidemia care. Participants randomized to usual care will receive     usual care from their pharmacist and physician.      Study Implications:      To the investigators knowledge, this study is the first randomized trial of pharmacist     prescribing in dyslipidemia. This study will have important implications for improving     patients' access to care, especially as most provinces are proceeding with granting     additional prescribing authority to pharmacists. The ability to conduct this study in a     province where pharmacists already have the ability to prescribe is unique. The results will     also encourage more pharmacists to get involved in cardiovascular prevention and will     increase the number of prescribers in the area of dyslipidemia.   "
130162|NCT01581307|"     The purpose of this study is to evaluate the safety and impact on survival with treatment     with 90-Y glass microspheres in conjunction with leucovorin, 5-fluorouracil (5-FU) and     oxaliplatin (FOLFOX) as second-line treatment with in patients gemcitabine-refractory     metastatic pancreatic cancer with predominantly liver metastases.   "
130163|NCT01581294|"     NOR-DMARD is a register-based longitudinal observational study of which the main objectives     are to study the effectiveness of treatment of inflammatory joint diseases with biological     disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease     activity, health related quality of life, function and joint damage, and to study the     long-term safety of such treatment. Other objectives include the assessment of     cost-effectiveness of treatment, to identify and and validate clinical, genetic and     immunological predictors of efficacy and adverse events, to assess the impact of treatment     with biological DMARDs on work participation and work productivity, to investigate different     strategies for use of biological DMARDs, to assess the performance of different outcome     measures, and to ensure a systematic and timely follow-up of patients treated with biological     DMARDs.   "
130164|NCT01581281|"     The purpose of this research study is to test two medicines for migraine prevention in     children and adolescents.   "
130165|NCT01581255|"     Mechanical ventilation, although life-saving, damages the lungs through what is known as     ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as a     ventilation method that may be less injurious to the lungs than conventional mechanical     ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the     OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress     syndrome randomized to high frequency oscillation ventilation vs conventional lung protective     ventilation. The present study is a substudy of the OSCILLATE trial looking at biomarkers of     ventilator-induced lung injury in blood samples drawn from patients enrolled in OSCILLATE.     The objective is to look for biochemical evidence of decreased ventilator-induced lung injury     in patients treated with high frequency oscillation ventilation relative to conventional     ventilation.   "
130166|NCT01581242|"     This is a randomized, open-label, three-sequence, three-period, three-treatment clinical     trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir     dipivoxil after oral administration in healthy male subjects.   "
130167|NCT01581229|"     To assess the safety and efficacy of noninvasive positive pressure ventilation for patients     with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration     oxygen therapy.   "
130168|NCT01581216|"     Fatigue related to cancer is the most common reported symptom and it prevents 91% of patients     of having an active life, and in several cases, the fatigue persists for several months or     even years after treatment. Fatigue does cause an impact in all dimensions of patients'     quality of life and it is the main cause of reduction in patients' daily life activities.      Fatigue is reported by cancer patients in all phases of the illness as one of the most     frequent symptoms, especially in cases presenting metastases.      In order to monitor fatigue, pharmacological and non-pharmacological techniques may be     employed, such as physical activity. Physical exercise has shown positive results in     mitigating fatigue improving cardiopulmonary functioning, physical capacity and patients'     quality of life.      This study will assess the efficiency of physical activity upon controlling the fatigue and     quality of life in patients with advanced stage of the disease at the end of 7 days using     FACT-F subscale.   "
130169|NCT01581203|"     The purpose of this study is to estimate efficacy, as determined by the proportion of     subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as     Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at     post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who     are treatment-naive.   "
130170|NCT01581190|"     This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate     drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress,     and innate immune function using traditional and metabolomics-based profiling.   "
130176|NCT01581112|"     The malodour generation of a person's armpit/foot is caused by the bacteria thriving on that     armpit/foot. In order to alter or reduce once bad body odour or foot odour, the living     microbial community on the foot/armpit of a non-malodorous person will be transmitted (or up     scaled and transmitted) to the foot/armpit of a malodorous person. The odour is evaluated by     a trained smelling panel, the bacteria living on the armpit/foot is examined by means of     molecular techniques. The microbial transplantation and its follow-up happens under the     supervision of a doctor.   "
130177|NCT01581099|"     Introduction- Primary prevention is the main strategy to control the global burden of     cardiovascular disease. In clinical practice, food restriction represents a valuable     preventive resource. However, low adhesion rates and diet abandonment are considered     important obstacles in treatment. Considering the discovery of new markers and mechanisms     that relate food restriction and to all other cardiovascular risk factors, it is possible and     necessary to seek for efficient alternatives to increase adherence and effectiveness of the     preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food     restriction. The bariatric surgery have gained importance not only for its potential     application in obesity treatment but also in the control of cardiovascular risk factors     refractory to medical treatment. Among bariatric operations, there is a group called     digestive adaptations III that has specific characteristics.This surgical intervention     modifies intestinal tract by reducing gastric volume and performing an anastomosis between     ileum and stomach, creating a bipartition in the gut. This structural modification promotes     satiety and increased insulin sensitivity more intensely than other surgical strategies. The     effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers     related to the development of atherosclerosis are not yet established.      Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and     laboratory parameters and cardiovascular risk factors.      Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal     obesity will be included in the study. Of this group, half will be randomly selected to     perform the Digestive Adaptations III surgery. All participants will undergo clinical and     biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four     months after surgery. On these occasions besides the lipid profile and glucose, we will     determine incretin hormones, adipokines and assess the amount of epicardial fat.   "
130178|NCT01581086|"     This study is looking for high blood pressure in the lungs (Pulmonary artery hypertension     PAH) in HIV and COPD patients.   "
130179|NCT01581073|"     The purpose of this study is to ask whether treating non-diabetic chronic kidney disease     (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and     13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The     investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher     adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to     11g/dL.   "
130181|NCT01581047|"     Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and     dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't     be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized     dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have     unpredictable pharmacokinetics in patients on intensive care units. This is due to the     pathophysiologic processes in the patients on intensive care units: increased distribution     volume, hypoproteinemia, organ failure… The investigators guess that similar processes     influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and     cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in     seriously ill patients are better known, physicians are more confident prescribing these     drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously     ill patients, can help to give the physician the confidence to prescribe these small-spectrum     antibiotics.      In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic     acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a     central catheter on different moments after one administration of the antibiotic in the     steady state phase. All the patients are prescribed the antibiotics for the treatment of     their infections: they get the antibiotic therapy anyway. By measuring the concentrations on     different moments after one administration, the investigators can reconstruct the     pharmacokinetic function.   "
130182|NCT01581034|"     This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week     intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems     in patients with coronary artery disease. The investigators hypothesize that PADMA 28 has a     beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen     and the blood inflammatory markers in patients with coronary artery disease compared to     placebo treatment.   "
130183|NCT01581021|"     Scoliosis is a deformity in which there is an abnormal curvature of the spine. Surgery is the     main method of correcting this deformity. Rods are attached to the spine to make it strait.     There are two ways to fix these rods to the bone of the spine: laminar hooks or pedicle     screws. Hooks are an older form of fixation and do not penetrate the bone, but are instead     placed over a part of the vertebra called the lamina. Screws are newer and do penetrate the     bone. Screws are placed into the part of the vertebra called the pedicle. Most surgeons think     screws correct scoliosis better than hooks. The current literature agrees that screws are     better for deformity correction in the lumbar spine and patients with severe deformity. There     is disagreement in the literature regarding which works better in the thoracic spine in less     severe deformity. There are no randomized, controlled trials in the literature that examine     whether constructs that use hooks in the thoracic spine and screws in the lumbar spine     (called hybrid constructs) work as well as all-screw constructs. This clinical study is a     randomized controlled trial being conducted to evaluate treatment outcomes in patients with     scoliosis undergoing surgical correction for their curves using either all-screw or hybrid     constructs as fixation devices. The study population is limited to those with less severe     deformity and the investigators' hypothesis is that hybrid constructs will be as acceptable     as screws in terms of correction.   "
130184|NCT01581008|"     The overall goal of this study is to evaluate the pilot implementation of two palliative care     interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is     a study of behavioral and care strategy interventions and involves no investigational drugs     or devices.   "
130198|NCT01580826|"     We hypothesize that short term infection-related benefits of human milk feeding are decreased     by the process of pasteurization. Primary objective of the study is to compare the incidence     of late-onset sepsis in very low birth weight infants assigned randomly to receive either     pasteurized or raw expressed mothers'own milk.   "
130185|NCT01580995|"     The purpose of this study is to examine the effects of valacyclovir in patients who have     chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies     to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold     sores or fever blisters, also known as herpes labialis, but most persons do not have any     symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug     administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic     hepatitis C infection.      The study will take 16 weeks. Participants will be assigned to take either the study drug,     valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and     patients will not know which medication they are receiving. Study visits will occur every two     weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V.     Sonny Montgomery VA Medical Center in Jackson, Mississippi.   "
130186|NCT01580982|"     The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined     from tumor tissue or tumor cell lines derived from available archival samples and/or from     standard-of-care re-biopsy upon suspected tumor progression.   "
130187|NCT01580969|"     The primary objective of step 1 is the rate of adverse events of minocycline and bevacizumab     during reirradiation and of step 2 is the response rate to bevacizumab, reirradiation, and     minocycline. The secondary objectives are the response rate, PFS-3, PFS-6, and effects on     quality of life and cognition from repeat radiation and bevacizumab.   "
130188|NCT01580956|"     Variable PSV is a new ventilatory mode which delivered a pressure support variable from 0     to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior,     sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and standard (or fixed)-PSV     during the weaning phase of critically ill patients who required mechanical ventilation.   "
130189|NCT01580943|"     The purpose of this study was to compare the antiplaque efficacy of a 0,12% chlorhexidine and     0,05% cetyl-pyridinium chloride mouth rinse (Perio-aid®) with a 0,2% chlorhexidine     non-alcohol base mouth rinse (Corsodyl Care®).   "
130204|NCT01580748|"     There is currently no effective treatment of bronchiectasis other than treating its     complications such as infection, bleeding, etc. Roflumilast is a newly developed     anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that     Roflumilast might be effective in symptomatic bronchiectasis patients   "
130205|NCT01580735|"     The primary objective of this study is to examine if the combination regimen of ARQ 197 with     erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating     mutation EGFR who progressed on EGFR-TKI monotherapy.   "
130190|NCT01580930|"     The purpose of this study is to determine if individuals involved in exercise training change     habitual activity and inactivity behavior outside of exercise training. Eligible participants     were randomly assigned to one of four groups: control, exercise training, sedentary time     reduction, or exercise training plus sedentary time reduction. It was hypothesized that     participants in the exercise training group will compensate for exercise training by reducing     free-living physical activity behavior and increasing sedentary time. Participant free-living     behavior was monitored for one week at baseline, 3, 6, 9 and 12 weeks using an activPAL     wearable monitor.   "
130191|NCT01580917|"     The purpose of this pilot study is to compare the dynamic response of microcirculation in the     skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic     subjects with a history of foot ulcer and 25 age-matched healthy controls to better     understand the role of local hypoxia in neuropathic foot ulceration in subjects with     diabetes.      The investigators hypothesize that if they apply a gait simulating load to the plantar foot     and measure microvascular function, diabetic individuals will demonstrate an increased delay     in reestablishing microvascular flow compared to healthy individuals.   "
130192|NCT01580904|"     The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug     treatment and to improve their quality of life. This study will measure the impact of     pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single     blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the     intervention group will be held the pharmacotherapeutic follow using a methodology called the     practice of pharmaceutical care, which identifies and resolves problems related to drugs. The     primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total     cholesterol and its fractions (for example LDL), all these measures will be made in the     intervention group and control group. Patients will be followed for 24 weeks, and the     outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a     significance of p <0.05, and will use the Student t test, chi-square analysis of variance     (ANOVA) and others if necessary. Expects good results and serve as a model for other     researchers.   "
130193|NCT01580891|"     The objective of this study is to evaluate the efficacy and safety of the test formulation of     Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed     formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients     with tinea pedis and to show the superiority of the active treatments over placebo when dosed     once a day for 28 days.   "
130194|NCT01580878|"     The primary objective of this study is to determine the comparability of the safety and     efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra®     (the reference listed drug) in subjects with interdigital tinea pedis. It will also be     determined whether the efficacy of each of the two active treatments is superior to that of     the vehicle cream (placebo).   "
130195|NCT01580865|"     Prospective, multi-center, randomized, controlled, trial to compare tacrolimus with     mycophenolate mofetil (MMF) for induces complete remission in lupus nephritis patients. The     study duration is one year.      Research hypothesis        -  The proportion of patients who have achieved complete remission between regimen of          tacrolimus plus prednisolone is greater than MMF plus prednisolone as an induction          therapy in lupus nephritis.   "
130196|NCT01580852|"     BACKGROUND: Bathing in sweet or mineral water can induce significant physiological changes in     several body systems including the endocrine system. To date, there have only been a small     number of reports that balneology can reduce blood sugar Levels in patients with type 2     diabetes mellitus (DM].      OBJECTIVE: To compare the effects of a immersion in sweet or mineral water on blood glucose     levels in patients with type 2 DM.      METHODS: Forty patients with type 2 DM will immerse in either sweet or mineral water twice     daily. In both cases the water will be warmed to a temperature of 35 degrees C and the bath     continue for 20 minutes.   "
130197|NCT01580839|"     The primary hypothesis being tested in this trial is that ischaemic stroke patients selected     with significant penumbral mismatch (according to imaging criteria) at 4.5 (or 3 hours     depending on local guidelines) - 9 hours post onset of stroke or after 'wake up stroke' (WUS)     will have improved clinical outcomes when given intravenous tissue plasminogen activator     (tPA) compared to placebo.   "
130199|NCT01580813|"     People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of     certain fats in their blood. The blood vessels and heart of most of these individuals do not     work normally and people with T2DM also have an impaired ability to perform exercise. The     purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily     decrease the level of fat in the bloodstream of people with T2DM and observe the     physiological changes to blood vessel function and exercise capacity and insulin sensitivity.     This will help the investigators to understand ways of improving blood vessel function and     the ability to exercise effectively in people who are overweight or have T2DM.   "
130200|NCT01580800|"     The purpose of the National Breast Cancer Lymphedema Registry is to collect health     information in order to study the lymphedema as a complication of breast cancer treatment.     The investigators hope to learn whether early diagnosis will help to prevent lymphedema or,     if it does occur, to reduce the severity.   "
130201|NCT01580787|"     The objective of this work was to compare the effects of two balance training programs, one     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,     on the balance, functionality and cognition of patients with Parkinson´s disease. It was a     prospective, single blinded, randomized clinical trial performed at Brazil Parkinson     Association and Center of Research of the courses of Speech Therapy, Physical Therapy and     Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages     1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and     experimental group, 16 each one.      The study was finished at december 2011.   "
130202|NCT01580774|"     The purpose of this study is to determine whether a post-discharge telephone call to general     medical patients discharged home will improve quality of care and adherence, and reduce     hospital readmission.   "
130203|NCT01580761|"     Insufficient sleep may be one of the most common, and most preventable, obesity risk factors.     The investigators wish to determine whether 14 nights of modest sleep restriction results in     increased energy balance, thus potentially increasing the risk of obesity. The investigators     hypothesize that sleep restriction will result in increased energy balance.   "
130207|NCT01580709|"     Differentiating malignant from benign bile duct strictures is a conundrum, since no     diagnostic test is highly sensitive for diagnosing cancer. While ERCP is effective in     palliating obstructive jaundice, standard diagnostic tools in ERCP have a low diagnostic     sensitivity and confirm the stricture's etiology in <50% of cases. During the first ERCP,     standard practice is to obtain routine cytology (RC) using a single brush sample. If this is     not diagnostic, patients often undergo repeat ERCP, endoscopic ultrasound or other,     increasing health care costs. The incremental yield of performing alternate ERCP-based     diagnostic tools during the first ERCP including fluorescence in situ hybridization (FISH),     cholangioscopy w/biopsy and multiple brushes for routine cytology is currently unknown. There     are no studies quantifying the amount of testing utilized to firmly diagnose the etiology of     the stricture, or the most efficient combination of diagnostic tools during the first ERCP.     These are important knowledge deficiencies since a definitive tissue diagnosis during the     first ERCP could reduce the need for downstream tests and expedite treatment, thereby     improving patient-centered and economic outcomes. The added costs of using multiple tools     during the first ERCP may be offset by these benefits.      Among patients with indeterminate bile duct strictures, the investigators hypothesize that a     multimodality approach will be more sensitive without a significant reduction in specificity     compared to multiple brush samples for routine cytology. The investigators will test this     hypothesis using an experimental trial design by randomizing patients during their first ERCP     to multiple brushing samples for cytology vs. a single brush sample for cytology + FISH +     cholangioscopy w/biopsy. To obtain preliminary data for a definitive multi-center trial, the     investigators propose a pilot and feasibility study to compare the performance     characteristics of each approach by evaluating the prospective clinical course, including     treatment delay, quality of life, and life expectancy for each enrolled patient. If our     hypothesis is validated in a subsequent definitive study, the standard approach to tissue     sampling during the first ERCP may be altered.   "
130208|NCT01580696|"     Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial     cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T     lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The     purpose of this study is to test whether a peptide-based vaccine consisting of the E39     peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating     factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune     response. Furthermore, the investigators intend to determine the best dose of the vaccine to     utilize to produce this immunity most efficiently. The investigators will determine whether     immunity to FBP will prevent clinical recurrence. Additionally, the investigators will     compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu     protein) in ovarian and endometrial cancer patients in preparation for studying a combination     vaccine.   "
130209|NCT01580683|"     The purpose of this study is to determine if vitamin C decreases the chance of developing     atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery.     This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in     about one third of patients. It poses extra risks to people who develop it. Our hypothesis is     that Vitamin C will decrease the incidence of postoperative atrial fibrillation.   "
130210|NCT01580670|"     The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's     Disease Activity Index (PCDAI) and other evaluation indicators in pediatric patients with     moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at weeks     0, 2, and 6, then every 8 weeks after week 14 up to week 46, and at a dose of 10 mg/kg if the     effect is attenuated. The safety and pharmacokinetics are also evaluated.   "
130211|NCT01580657|"     Randomized clinical trials of HIV prevention interventions typically include extensive     baseline assessments of the risk behaviors that interventions target. Such pretests have the     potential to direct participants' attention to the factors that put them at risk of HIV     infection. Evidence from intervention study control groups, the motivational enhancement and     attitude change literature, and our preliminary studies suggest that assessments that lead     people to think about behaviors with potentially negative outcomes lead to motivation for     risk behavior reduction. As a consequence, HIV intervention research using baseline     assessments may not accurately predict the impact of a given HIV prevention intervention     outside of the research context, in particular when interventions are evaluated among     high-risk, isolated individuals. However, the actual effects as well as public-health     consequences and mechanisms of HIV assessment reactivity have never been systematically     tested.      The proposed assessment reactivity study will be conducted in South Africa, a country with     high levels of HIV prevalence, incidence, and stigma. The Republic of South Africa's HIV/AIDS     epidemic has emerged recently relative to other sub-Saharan countries, and yet 21.5% of South     Africans aged 15-49 -- more than 1 in 5 people -- are infected with HIV (UNAIDS, 2004).     Despite the common presence of HIV in South Africa, it remains largely a hidden disease and     HIV-related stigma interferes with peoples' ability to protect themselves through open     discussion or spontaneous reflection on personal risk. Under these conditions, it is     reasonable to expect a sizable effect from directing people's attention to their HIV relevant     behaviors, an effect that could be incorrectly ascribed to brief interventions used in     low-resource settings. The conditions in South Africa, therefore, heighten the clinical and     public health significance of the assessment reactivity issue in that (a) it is vital to     understand how reactivity may affect the results of behavioral intervention trials, and (b)     it may be possible to capitalize on assessment reactivity through brief, assessment-based     interventions.      This study will allow us to achieve our primary aim:      1. To separate the effect of a brief HIV-risk reduction intervention from the potential     effects of two types of baseline assessment commonly applied in HIV intervention research: a     detailed, calendar-based assessment and a general frequency assessment. The detailed     calendar-based assessment will potentially lead participants to observe themselves in     specific risk-behavior situations, providing them with the opportunity to reassess the risk     involved in those situations in light of their health goals and thus motivating them for     behavior change. The general frequency assessment will merely prompt participants to estimate     the overall frequency with which they engaged in several HIV-related behaviors. The effect of     these assessments on participants' sexual behavior will be examined alone and in combination     with the HIV-risk reduction intervention.      In addition, this project has two important secondary aims:        1. To generate urgently needed additional efficacy data for a promising HIV risk reduction          intervention culturally tailored for use and found to be effective in South Africa        2. To determine potential HIV preventive effects of different types of HIV risk behavior          assessments on risk behavior reduction in South Africa for future intervention          development      To achieve the above aims, the investigators will:        1. Recruit 1500 patients (50% women), age 18-44, from the Spencer Rd. STD Clinic, Cape          Town, South Africa.        2. Randomly assign participants within gender to one of 6 study arms in a modified Solomon          Four-Group (SFG) design. The 2 (intervention: standard of care vs. an efficacious theory          based HIV prevention intervention) x 3 (baseline face-to-face interview: none vs. basic          single-item frequency questions vs. detailed partner-by-partner calendar-based          interview) factorial design is depicted below:   "
130212|NCT01580644|"     The purpose of this study is to evaluate the amount of GLPG0187 present in the blood     (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy     subjects.      Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and     dose proportionality of the best formulation.      Furthermore, during the course of the study, safety and tolerability will be characterized.   "
130213|NCT01580631|"     Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415     nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's     microvasculature and enhances detail on the surface of the mucosa revealing subtle changes.     Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by     angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise     for the prediction of dysplasia in BE mucosa.      NBI images of the BE mucosa obtained during endoscopy will be classified by academic     endoscopists and community endoscopists initially. The endoscopists will then be asked to     predict histopathology based on the NBI surface patterns. This clinical trial will evaluate     the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI)     classification system of surface patterns and its ability to differentiate dysplastic versus     non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance in     expert academic centers and in community GI practice as well. Their performance will be     evaluated for accuracy, sensitivity, specificity, positive predictive value and negative     predictive value of each pattern that is visualized on NBI.   "
130214|NCT01580618|"     The objective of the study is to determine the safety and efficacy of TNK infusion for the     treatment of loculated pleural effusions in patients with known malignancy compared to normal     saline infusion.   "
130215|NCT01580605|"     This study is conducted in Europe. The aim of this study is to extract data from the French     National Registry holding information about patients having initiated growth hormone therapy     with the objective to describe patients receiving growth hormone therapy, assess efficacy and     safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.   "
130216|NCT01580592|"     Urticaria is a very frequent skin condition characterised by transient wheal and flare type     skin reactions associated with severe pruritus. Cold contact urticaria (CCU) is a frequent     form of physical urticaria that is characterized by the development of wheal and flare type     skin reactions due to the release of histamine and other proinflammatory mast cell mediators     following exposure of the skin to cold. Among all physical urticaria subtypes the frequency     of CCU varies between 5.7% and 33.8% in different studies. Physical urticarias including CCU     are known to severely impair the quality of life of affected patients.      The treatment of choice in CCU, as well as in other inducible forms and spontaneous     urticaria, are non-sedating H1 antihistamines. Recent data have shown that updosing of H1     blockers is significantly more effective in reducing symptoms in cold urticaria than     standard-dose treatment. Thus, patients who cannot be sufficiently controlled with     standard-dose antihistamines should receive high-dose H1 blockers up to 4 times the standard     dose as recommended by the new international guidelines for the management of urticaria.      Previous phase II studies in patients with chronic spontaneous urticaria have shown favorable     results for the treatment with omalizumab (Xolair®). Proof-of-concept data from completed     studies suggest that omalizumab improves urticaria in patients with chronic spontaneous     urticaria who have failed treatment with H1 antihistamines as well as those who have failed     treatment with a combination of H1 and H2 antihistamines and a leukotriene receptor     antagonist. In addition, two case reports of patients with severe therapy refractory CCU     treated with omalizumab reported a complete response with no urticarial symptoms after cold     challenge. In summary, these data suggest that omalizumab may have a beneficial effect in the     treatment of CCU.   "
130242|NCT01580241|"     The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients     with pancreatic cancer. The investigators would like to analyze its expression pre and post     treatment, to gauge the correlation between current pancreatic cancer therapies and the     expression of DCAMKL-1   "
130217|NCT01580579|"     Lung cancer [LC] is the leading cause of cancer death worldwide. The standard treatment of     locally advanced lung cancer unresectable or marginally resectable is combination therapy     with radical or preoperative chemoradiation. The local control rates and survival with this     treatment modality have increased by more than 30%. Radiotherapy [RT] with technical molded     3D [3D-CRT, Three-Dimensional Conformal Radiation Therapy] or IMRT [intensity-modulated     radiation therapy] has allowed that the total dose of radiation has increased which leads to     a direct benefit on the results treatment.      Between 17-30% of patients are susceptible to pneumonitis due to radiation [NR]. This     complication may appear at the end of the RT or up to 6 months after the treatment. In severe     cases, mortality can reach 50%.      It's well known that in various diseases, functional abnormalities precede the clinical     manifestations. The degree of pulmonary failure secondary to RT is measured following the     standards of the Radiation Therapy Oncology Group who ranks in degrees [0 to 4].      Not precisely known factors that influence the development of NR.   "
130218|NCT01580566|"     The purpose of this study is to determine if a sizable myocardial infarction (heart attack)     results in negative changes to renal structure and function (i.e. has a negative impact on     the kidneys).      To determine if the renal response to a myocardial infarction is a predictor of the patients     future health.   "
130219|NCT01580553|"     The purpose of this study is to evaluate the efficacy and safety of L-carnitine injection in     treatment of Chinese patients with heart failure.      A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical     study was performed.      Treatment period: 7 days, follow-up: 1 month   "
130220|NCT01580540|"     The study aims to show non-inferiority in the clinical performance of the investigational     assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline     eligible subjects.   "
130221|NCT01580527|"     Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality     partially related to the altered nutritional status of the patients. The perioperative     malnutrition is a major risk factor of postoperative complications and worsens the prognosis     of the patients. The perioperative artificial nutrition has for objectives to correct the     preoperative malnutrition, and to maintain the nutritional status in the post-operative     period. The current guidelines in surgery are in favour of a realisation of a perioperative     artificial nutrition support that privilege the enteral nutrition. However, after     pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the     early postoperative period, although rare studies suggest a benefit of the enteral nutrition     in term of reduction of the post-operative complications. Indeed, no recommendation was     formulated concerning early enteral nutrition after pancreaticoduodenectomy because few     studies were realized on its profits.      The data of the literature report rates of complications (essentially major) from 49 % to 59     % after major digestive surgery (not only pancreatic) on patients having received a total     parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early     enteral nutrition.      A preliminary prospective study realized in the investigators centre showed a rate of 74 %     complication versus 44 %, respectively in the total parenteral nutrition and early enteral     nutrition groups (50 patients in every group, with p < 0.01. All the complications were     listed prospectively).      Hypothesis :      The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at     least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 %     versus 40 %).   "
131150|NCT01568372|"     The purpose of this study is to determine if a nurse telephone follow-up to parents of     children who underwent a removal of their tonsils would be effective in reducing pain     intensity, complications and resort to other healthcare services   "
130223|NCT01580501|"     PDE5A inhibition, which boosts NO-cGMP signaling, will relieve functional muscle ischemia and     restore normal blood flow regulation (i.e., functional sympatholysis) during exercise in boys     with DMD. The investigators specific aim is to perform an efficient dose-titration study to     inform the design of a randomized multicenter trial of PDE5A inhibition for clinical skeletal     muscle and cardiac endpoints.   "
130224|NCT01580488|"     The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different     formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the     psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.   "
130225|NCT01580475|"     -  This study examine the effects of training, detraining and retraining, using a combined          strength and aerobic exercise program, on physiological parameters in patients with type          2 diabetes.        -  Thirteen women with type 2 diabetes followed a supervised aerobic and strength training          program for 9 months, interrupted for 3 months (detraining) and resumed again for a          period of 9 months (retraining).        -  Training improved body mass index, fasting plasma glucose,postprandial glucose,          glycosylated hemoglobin, peak oxygen consumption,power output and total muscle strength.          Detraining reversed PPG, HbA1C and physical fitness parameters. Resumption of training          however, improved further the initial training adaptations.        -  Diabetic patients should follow a regular and uninterrupted exercise program throughout          life in order to control glucose metabolism and improve health status.   "
130226|NCT01580462|"     The aim of the research is to develop a mathematical model called ADHERENCE index, and to     evaluate its effectiveness.   "
130227|NCT01580436|"     De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following     mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve     annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when     tricuspid annular dilatation is present even in absence of significant TR. However, whether     such a strategy of prophylactic TVP results in improved outcomes has not been shown to date     by a prospective randomized study. The investigators goal is therefore to initiate such a     study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients     scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.   "
130243|NCT01580228|"     This study is being conducted to demonstrate the superiority in progression-free survival     (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants     with del 17p or in the overall population who are refractory to either fludarabine treatment     or chemoimmunotherapy.   "
130244|NCT01580215|"     This is an observational prospective single arm multicentre study to observe the effect over     5 years of Zephyr endobronchial valve therapy for emphysema.   "
130228|NCT01580423|"     Substance P is released from sensory nerves and transmits pain information into the central     nervous system. As pain and dyspnea share many characteristics, including similar     neurological pathways, it is possible that substance P may contribute to the sensation of     dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary     disease (COPD) will provide lower ratings of breathlessness during resistive load breathing     with oral aprepitant, a medication that blocks the activity of substance P, compared with     placebo.   "
130229|NCT01580410|"     This randomized phase II trial is studying the side effects and how well giving oxaliplatin     or mitomycin C directly into the abdomen after surgery works in treating patients with tumors     of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen     may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells     that remain after surgery.   "
130230|NCT01580397|"     Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas     (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor     prognosis with progression-free survival of around 13 weeks and median overall survival of     approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin     may be preferentially concentrated in pancreatic cancers that appear to be starved for this     protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on     its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without     increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced     anti-tumor efficacy.   "
130231|NCT01580384|"     This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability     of neurocognitive tests and functioning scales for the measurement of cognitive and     functioning changes in individuals with Down Syndrome. Tests will be administered at clinic     visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between     24 and 27 weeks.   "
130232|NCT01580371|"     This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT),     safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with     Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by     response rate, progression free survival.   "
130233|NCT01580358|"     Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help     these people improve the quality of life.   "
130234|NCT01580345|"     The 'DHANI randomized controlled trial seeks to examine the effects of prenatal DHA     supplementation on newborn anthropometry where in healthy pregnant will be assigned to     receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.   "
130235|NCT01580332|"     Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk     populations (age >50yo, >30 pack-years of tobacco use), and can lower cancer mortality.     Unfortunately, the vast majority of positive findings on these CT scans are benign (>95%).     Currently, an inordinate amount of expensive follow-up testing is required for these patients     to try to prove who among them truly has a cancer.      Several new emerging non-invasive and potentially cheaper tests are now being investigated to     help differentiate patients with cancers versus just benign lung nodules. These new tests     include a new type of sputum analysis, a breath analysis, a blood test measuring certain     tumor markers, a blood test looking for auto-antibodies, and a standard PET/CT scan. Each of     these tests have different sensitivity and specificity rates when looking for lung cancer,     and it is unclear which test is best.      This study will employ a panel of all 5 of these non-invasive tests on an initial cohort of     50 patients with recently diagnosed lung cancer to try to measure the sensitivity of the     tests. A follow-on study will then perform the same panel of tests on 300 lung nodule     patients to see which test, or combination of tests, gives the best overall accuracy in terms     of predicting who really has lung cancer. It is hoped that the use of such a panel could lead     to dramatically decreased need for expensive and morbid invasive testing for this population.   "
130238|NCT01580293|"     Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to     form blood clots is missing or not present in sufficient levels. In a person with haemophilia     A, the clotting process is slowed and the person experiences bleeds that can result in     serious problems and potential disability.      The current standard treatment for severe haemophilia A is regularly scheduled infusion of     FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII,     prophylaxis may require treatment as often as every other day.      In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is     evaluated in subjects with severe Hemophilia A.      120-140 patients will receive open label treatment with long-acting rFVIII either on-demand     to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension     to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic     treatment will receive study drug at dosing intervals between once and twice a week depending     on their observed bleeding. Patients will attend the treatment centre for routine blood     samples and be required to keep an electronic diary.      Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at     least 50 exposure days may be eligible for this study.   "
130239|NCT01580280|"     Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper     thoracic thrust manipulation will demonstrate significant and clinically important changes in     outcomes when compared to the mobilization and exercise group.   "
130240|NCT01580267|"     Anemia (decreased number of red blood cells) is common in critically ill trauma patients     admitted to an Intensive Care Unit and is associated with a high rate of blood transfusions.     This anemia of inflammation is a result of three mechanisms: impaired iron regulation,     shortened red blood cell life span, and reduced rate of erythropoiesis (a protein that helps     make new red blood cells).      Hepcidin, a protein made in the liver, regulates iron and is decreased when iron in the blood     is low. This can lead to anemia.      This research study is being conducted to learn how inflammation, hepcidin, and     erythropoietin interact in critically ill patients. The findings will help in determining     effective treatment for patients with anemia of inflammation.   "
130245|NCT01580202|"     Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of     HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in     such circumstance according to the practice guidelines despite of limited evidence. However,     failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs     occasionally, which may lead to liver-related morbidity and mortality as well as premature     interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM,     studies on the proper prophylactic antiviral regimen is warranted. The present multicenter,     prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for     the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic     malignancy undergoing cytotoxic chemotherapy.   "
130246|NCT01580189|"     The purpose of the study is to examine the effects of consuming protein supplement (whey)     compared to whole milk immediately after bouts of resistance training on muscular strength     and body composition.   "
130247|NCT01580176|"     This study will be the first study in which the new central venous microdialysis-based     continuous glucose monitoring system (Continuous GlucoseMonitor) is used to investigate the     performance of this Continuous GlucoseMonitor, as the measurements will be compared with a     point of care reference (RAPIDLab® 1265 blood gas analyser). Further important points are     also much less blood samplings / blood loss for the patient and personnel costs.   "
130248|NCT01580163|"     The purpose of this research is to observe the efficacy of comprehensive treatment model to     improve treatment compliance and relapse prevention.   "
130249|NCT01580150|"     The purpose of this study is to investigate whether berries are effective in lowering blood     glucose and insulin responses to meals containing starch or sucrose.   "
130250|NCT01580137|"     The purpose of this study is to find out if we can predict the progress of acute upper     respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by     symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric     oxide measurement.   "
130251|NCT01580124|"     Study design:      Randomized prospective comparison of pulmonary vein isolation alone versus a strategy aiming     for atrial fibrillation termination by using a stepwise approach consisting of pulmonary vein     isolation, biatrial defragmentation aiming for fractionated electrograms and linear ablation     if required.   "
130252|NCT01580111|"     In resolving lactic acidosis among children with severe malarial anemia, there is no     difference between those transfused with blood of longer storage compared to shorter storage     age   "
130253|NCT01580098|"     Evaluation whether the introduction of large-scale personalized and technology supported     telemonitoring and health coaching interventions produces benefits in terms of health related     quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In     addition, the trials evaluate the economical and organizational impact of the new services     and examine their acceptability by patients and health professionals.   "
130359|NCT01578707|"     The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy     results in a clinically significant improvement in progression free survival (PFS) as     compared to treatment with ofatumumab in patients with relapsed or refractory Chronic     Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)   "
130254|NCT01580085|"     Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of     the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in     intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall     may ensue. An increased tendency for coagulation has also been reported in OSA. Venous     stasis, vascular endothelial activation and hypercoagulability are also known risk factors     for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients for     the development of pulmonary embolism (PE) however there is limited data about role of     thromboembolic events in OSA.   "
130255|NCT01580072|"     Evaluation whether the introduction of large-scale telemonitoring of patients with COPD     produces benefits in terms of reduced hospital readmissions, improved health related quality     of life and health status. In addition, the trials evaluate the economical and organizational     impact of the new services and examine their acceptability by patients and health     professionals.   "
130256|NCT01580046|"     The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients     with renal dysfunction.   "
130257|NCT01580033|"     Haemophilus influenzae is an important pathogen which can cause primary infection and     respiratory viral infection in infants and leaded to secondary infections. The infection of     haemophilus is a major cause of morbidity and mortality in infants and children. At present,     the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine     can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused     by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal     immune programming.      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus     polysaccharide vaccine with a relatively poor immune response in the infants under the age of     two, and the remaining 60% with a low antibody level and a short duration.      The immunogenicity and safety of this vaccine has been proved in older children aged 6-23     months and 2-5 years. And in the phase I study which was conducted in February, 2012, the     safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The     phase III study is aimed to further evaluate the safety and the immunization of the vaccine.     The objective of this study is to evaluate the safety of the group A, C polysaccharide     meningococcal and type b haemophilus influenzal conjugate vaccine.   "
130258|NCT01580020|"     The study is intended to characterize the clinical benefit regarding safety and efficacy of a     long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and     a 3-month follow-up period, following the initial 6-month treatment in the respective core     studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).   "
130270|NCT01579864|"     Myorelaxation is generally used as a part of general anesthesia for interventional rigid     bronchoscopy. Succinylcholine is most often used because its short duration of action but     rocuronium can be used since sugammadex permits a rapid and complete reversal of the     neuromuscular block. The aim of ths study is to compare both agents.   "
130259|NCT01580007|"     Vitamin D exerts its effects via the Vitamin D Receptor (VDR) present in activated     macrophages and induces expression and release of the cathelicidin, LL-37, a human     antimicrobial peptide involved in killing of MTB. We aimed to investigate whether treatment     of newly diagnosed pulmonary TB patients for 2 months with adjunctive PBA and vitamin D     (Cholecalciferol) in combination with standard DOTS therapy (i) can improve response to     standard short course TB therapy towards a rapid recovery; (ii) can induce expression of     LL-37 in macrophages; (iii) can enhance killing capacity of macrophages isolated from TB     patients infected in vitro with MTB; and (iv) does not evoke any adverse effects.   "
130260|NCT01579994|"     About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the     study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard     dose of crizotinib. If this dose does not cause significant side effects, it will be     increased as new patients take part in the study. The study will only be open at Memorial     Sloan Kettering Cancer Center.   "
130261|NCT01579981|"     After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased,     while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this     study is to establish causality between the two observations. By meal testing 10 T2D subjects     with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3     months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function     and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec     blockade before and after RYGB on ad libitum energy intake is examined   "
130262|NCT01579968|"     This study is conducted in Japan. The aim of this non-interventional study is to investigate     the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing     surgery under normal clinical practice conditions.   "
130263|NCT01579955|"     This study is conducted in Japan. The aim of this non-interventional study is to investigate     the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal     clinical practice conditions.   "
130264|NCT01579942|"     The investigators are doing this study to find out if they can use electroencephalographic     (EEG) recordings, which measure brain waves, to predict response to antidepressant     treatments, as well as to distinguish patients who have depression from those who do not. In     particular the investigators want to test the usefulness of a new type of analysis of EEG     recordings called brain network activation or BNA. BNA allows to identify patterns of     activation in brain networks and to track their changes over time.   "
130279|NCT01579747|"     Ultrasound have been shown to improve the time needed to locate and block nerves in the non     obese population. However, its utility is still unknown in the obese population. Ultrasound     is known to produce poorer quality images in the obese population. This study aims to find     out if it is a better tool for nerve localization compared to the traditional nerve     stimulation technique.   "
130280|NCT01579734|"     The propose of this trial is to assess the effect of low dose tamoxifen for breast cancer     prevention in HRT (Hormone Replacement Therapy)users.   "
130281|NCT01579721|"     Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and     cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma.     However, the feasibility of this procedure in rectal surgery has not been determined yet. The     aim of this study is to evaluate our initial experience using single port access in     laparoscopic rectal surgery.      Design: randomized, prospective clinical study Patients: 40 patients   "
142399|NCT01420601|"     To confirm the safety of the long-term use of TORISEL 25 mg for Intravenous Drip Infusion     particularly for the onset of interstitial lung disease from Weeks 25 to 96 after the start     of administration.   "
130265|NCT01579929|"     The purpose of this study is to test the safety of study drug LDE225 at different dose     levels. The investigators will be testing three different dose levels and the dose will     depend on when the patients enters the study and which dose is being tested at that time. At     the same time, the investigators will also be testing the safety of LDE225 in combination     with etoposide and cisplatin.      The investigators also want to learn more about how to manage side effects the patient may     develop during chemotherapy. Cancer patients may develop side effects during treatment, such     as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. These symptoms may     be due to the cancer itself, or due to treatments. Doctors and nurses often ask patients     about their symptoms, because an important part of cancer treatment is to make patients feel     as well as possible. If patients do not feel well, the investigators may need to change the     way they are treating the patients or prescribe therapies that will decrease their symptoms.      The best way to find out how the patient is feeling is to ask them directly. The     investigators are interested in developing new ways to ask patients about how they are     feeling, using the Internet. A special new website called STAR (Symptom Tracking and     Reporting for Patients) has been developed to help patients record this information, so that     their doctors and nurses can review it during clinic appointments. This study is designed to     help us see if STAR is a helpful way for us to keep track of information about patients'     symptoms and quality of life. The information from STAR is going to be placed on a very     secure Internet site. This will provide your doctor with all of the information needed to     determine if this drug combination is safe enough for you and whether to continue it.   "
130266|NCT01579916|"     This prospective annual release study was designed to assess the safety of a trivalent     influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season     not previously contained in the trivalent intranasal FluMist vaccine.      Three hundred healthy adults will receive a single dose of vaccine or placebo and will be     followed for 180 days after study vaccination.   "
130267|NCT01579903|"     This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when     administered as 2 different dose presentations. The first is the current product vials with     prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.   "
130268|NCT01579890|"     This was a compassionate use, open treatment safety study of Pennsaid topical lotion     (diclofenac) for osteo or rheumatoid arthritis.   "
130269|NCT01579877|"     The aims of this study are to investigate the effect of famous herbal formula extract on     xerostomia, and to determine whether this formula affect various xerostomia-related     questionnaires, salivary flow rate, residual saliva and salivary tests.   "
130271|NCT01579851|"     Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its     administration could induce signs of recovery despite continuation of anesthetic drugs. The     goal of the present study is to look is the arte of this event is different according to the     primary anesthetic agent used.   "
130272|NCT01579838|"     The investigators have identified patients with CD59 deficiency that suffers from chronic     hemolysis and peripheral demyelinating disease. It was shown that complement terminal pathway     can cause inflammation in the peripheral nervous system. Complement can greatly increase the     immune attack in the nerves. Eculizumab has already been shown to be effective in a rare     blood disorder known as paroxysmal nocturnal hemoglobinuria (PNH). Attacks of PNH are also     mediated through complement. Therefore, the investigators of this study are investigating     whether by 'turning off' complement in CD59 deficiency, further attacks of hemolysis and     nerve injury can be avoided and whether the neurological status will ameliorate.   "
130273|NCT01579825|"     Hypothesis:      The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who     receive bicarbonate buffer at the time of polio immunization.   "
130274|NCT01579812|"     The primary objective of this study is to determine if metformin administered in combination     with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer     will improve recurrence-free survival at 18 months compared to controls.   "
130275|NCT01579799|"     This is a pilot dose-finding study, which is performed with a randomized, double-blind,     3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine     Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized     sequence on three different study days in six healthy volunteers. Each study day involves the     repeated measurement of gastric content volume, gastric secretion volume and intestinal fluid     volume using MRI before and after intragastric infusion of L-lysine Monohydrate test meals.     Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and urge to     defecate will be recorded using a scale from 0-10. In parallel, samples of gastric juice to     measure intragastric pH and pepsin concentration, samples of venous blood to assess blood pH     and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin plasma     concentration and samples of arterialized blood from ear lobe to measure glucose blood     concentration will be collected   "
130276|NCT01579786|"     The aim of the study was to evaluate if acupuncture may reduce intraoperative ULTIVA     (remifentanil) consumption and post operative pain measured with VAS, italian version Mc Gill     Questionnaire Pain and drug consumption (acetaminophen daily consumption).   "
130277|NCT01579773|"     The purpose of this study is to learn if women gain weight using progestin-only methods of     contraception and if so, how much. The investigators will look at users of two progestin-only     methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the     etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of     users of a non-hormonal method, the copper intrauterine device.      The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition     will increase more than the copper-IUD users. The investigators will collect body composition     data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and     activity using validated questionnaires.   "
130278|NCT01579760|"     The purpose of this study is to assess the safety of intravitreal aflibercept injection - in     the treatment of macular edema associated with retinopathy secondary to previous radiation     therapy.   "
130282|NCT01579708|"     Cardiovascular disease continues to be the principal cause of death in the world. At present,     the risk factors for cardiovascular disease continue to appear at an earlier age permitting     prevention activities and the promotion of healthy habits to focus on children. Numerous     studies have shown that these factors can be controlled in children through school-based     interventions. At the same time, data shows that there is a persistence of unhealthy     lifestyles (ie sedentary lifestyles, the use of tobacco, etc…) that begin in childhood and     are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should     begin as early as possible. The SI Program for Preschool Education is an intervention that is     both school and home based designed to improve the habits, knowledge and attitudes in four     key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This     intervention will be implemented in children from three to five years of age, in their     parents and in their teachers. To evaluate the efficacy of this intervention, the principal     aim of the phase of evaluations is to quantify the behavior changes in the three     groups/populations mentioned. The evaluation has been designed according to the controlled     intervention model, in which twenty-four schools from the Community of Madrid will be     randomized to implement the Program si! for Preschool Education or to function as control     schools.   "
130283|NCT01579695|"     The purpose of this observational, 10-year, prospective cohort study is to assess the     potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with     abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.   "
130284|NCT01579682|"     Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric     disorder. The most promising treatment for adolescents with AN is family-based treatment     (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up.     Consequently, providing an alternative therapy early in the treatment course for those not     responding to FBT may enhance overall outcome. This study aims to develop a new treatment -     Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged     12-18 years, who do not show an early response to FBT.   "
130285|NCT01579669|"     The goal of this proposal is to develop and evaluate patient-centered care tools for autistic     adults and their primary care providers (PCPs).   "
130311|NCT01579331|"     Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular     pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be     compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the     gold standard technique.   "
130329|NCT01579097|"     The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared     to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in     hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or     contraindicated.   "
130286|NCT01579656|"     Consumption of whole grains has been heavily endorsed by both government and major health     agencies, as evidenced in Health Canada's Food Guide, the US Department of Agriculture's Food     Pyramid, and the Heart and Stroke Foundation's healthy eating guide. Whole grains have been     championed for their proposed cardioprotective and weight control effects as suggested by     epidemiological studies. The health benefits of whole grain products may be attributable to     their nutrient composition, which contains dietary fibre, protein and several essential     nutrients. There has also been a concurrent increase in seed consumption. Seeds have a     similar and potentially superior nutritional composition to whole grains and they are rich in     mammalian lignans and polyunsaturated fats, especially the highly valued omega-3 fatty acids.     Preliminary studies on seeds have shown that they impart health benefits similar to those     imparted by whole grains. Consumer choices regarding seed consumption may be based on their     potential health benefits. Furthermore, they may also be affected by subjective sensory     factors, such as appearance, taste and pre-conceived perceptions. Therefore, this study will     compare the health properties of four seeds and their effects on appetite and sensory     parameters in healthy individuals. These four seeds will be that of flax, poppy and sesame,     due to their popularity and consumption as well as Salba, which has also recently received     much attention for its associated health benefits.   "
130287|NCT01579643|"     The primary goal of the trial is to determine if laser-assisted lamellar anterior     keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions,     glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).   "
130288|NCT01579630|"     The study aims to randomize 52 patients with advanced (Stage IV) EGFR mutation negative     nonsquamous non-small cell lung cancer (NSCLC) who respond (CR/PR/SD) to 4 cycles of     pemetrexed / cisplatin or pemetrexed/carboplatin as first-line therapy. In order to achieve     that, approximately 144 treatment naïve patients with advanced nonsquamous NSCLC need to be     enrolled from around 6 investigational sites in Taiwan that have expertise in lung cancer     diagnosis.   "
130289|NCT01579617|"     The purpose of this study is to evaluate the efficacy of an online pregnancy prevention     intervention that was adapted from the evidence based small group intervention SiHLE.   "
130290|NCT01579604|"     The cervical spine is most commonly injured, accounting for 53.4% of spinal injuries. More     than 40% of all spinal injuries occur at either C4, C5 or C6 levels leading to variable loss     of function in the upper extremities.      Traditionally, patients sustaining a cervical spine injury were followed for 2 years to     ensure that recovery had stabilized before offering upper extremity reconstruction. This type     of reconstruction includes active muscle transfer, tendon transfer and joint fusion.      Patients are most commonly assessed immediately at the time of injury. Muscle testing is     commonly performed using Medical Research Grading System (MRC).      Although complete neurologic stabilization may not be complete until 2 years post-injury, in     the group with initial grade 0 muscle strength after the acute phase of injury, expectations     of improved muscle strength to or beyond grade 3 after 4-6 months is minimal. And grade 3     muscle strength is felt to be the minimum useful functional strength in a muscle group.      The investigators propose an early nerve reconstruction approach to the tetraplegic patient     with dysfunction of the upper extremity to augment the available tendon transfers.      A comparative pilot study is proposed to determine the effectiveness of supinator branch to     posterior interosseous nerve (PIN) transfer in 5 patients with cervical spine injury. Patient     who fits inclusion criteria will be offered the opportunity to be involved in the study and     reviewed at 6 months from injury. If the patient still has not regained Grade 3 power in     finger or thumb extension, they will be randomized to be in a surgical group or non-surgical     group.      If informed consent is obtained, then surgery will be completed between 6-9 months from the     patient's original cervical spine injury. The patient will be followed at regular intervals     post-operatively with expectation of 18-24 month follow-up.      Measures will be used pre and post-operatively for comparison. Measures will include MRC     muscle grade (EDC), range of motion, DASH, and GRASSP (Kalsi-Ryan, 2011).   "
130291|NCT01579591|"     This is a randomized, double-blind, placebo-controlled phase III study involving 160 patients     designed to assess the efficacy of the high potency probiotic preparation VSL#3® versus     placebo in increasing the pathological major response rate in patients undergoing concurrent     CT and pelvic RT.   "
130292|NCT01579578|"     The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus     paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal     junction, cancer.   "
130293|NCT01579565|"     The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302     (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain     in individuals undergoing Intraocular Lens Replacement (ILR) surgery.   "
130294|NCT01579552|"     The purpose of this study is to empower women to improve their health in two very important     areas: breast and heart health. This twelve-month study will compare two methods of informing     participants about potential health risks and ways to stay healthy.      The EMPOWER Study has been designed for adult women who were treated for a childhood cancer     with chest radiation.   "
130295|NCT01579539|"     Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye     disease, is a common orbital disease in adults. Patients with TAO, especially in its active     phase, often complain about symptoms of ocular surface discomfort, including excess tearing,     gritty sensation, increased sensitivity to light and foreign-body sensation, which are     similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete     blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear     evaporation, which increases the tear fluid's osmolarity, and results in ocular surface     damage. The administration of intravenous glucocorticoids can be an effective treatment for     TAO.      The rationale of the present study is to assess the effect of intravenously administered     glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement     of tear film thickness, tear film osmolarity and scattering of the tear film and well     established methods for assessment of the severity of DES. Additionally, impression cytology     and determination of tear cytokines/chemokines will be performed to obtain information about     inflammatory processes on the ocular surface.   "
130296|NCT01579526|"     The purpose of this study is to determine the safety and pharmacokinetics of FP01 in healthy     volunteers.   "
130312|NCT01579318|"     A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor     activity of intratumoral IL-12 plasmid (i.e., pIL-12) electroporation in subjects with stage     IB to IIIB mycosis fungoides.      All subjects may receive up to six cycles of treatment consisting of two treatment days, Days     1 and 8, in a 28-day cycle. Patients will receive intra-tumoral injection of pIL-12 at a     concentration of 0.5mg/ml and a fixed volume of 0.25 mL per each 1.0 cm diameter of target     region, followed immediately by electrical discharge around the tumor site resulting in     electroporation of plasmid DNA into tumor cells.   "
130297|NCT01579513|"     Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart     surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent     inflammatory response secondary to the body's recognition of the abnormal environment of the     heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney     function after the heart surgery. This is turn can lead to longer times on the ventilator     (breathing machine), the need for higher doses of heart medications, a longer stay in the     intensive care unit and even death. This is particularly true in infants less than one month     of age due to their size and the immaturity of their organs. The appreciation of the     post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions     directed at its reduction. No therapy has been recognized as the standard of care; however     steroid therapy has been applied most often despite unclear evidence of a benefit. This study     aims to determine if steroids improve the outcomes of babies undergoing heart surgery.   "
130298|NCT01579500|"     The purpose of this study is to determine whether botulinum toxin A is effective in the     treatment of neuropathic pain in spinal cord injury patients.   "
130299|NCT01579487|"     This study is being performed to follow up on subjects who participated in the initial study     (ZA10-001) in 2010.   "
130300|NCT01579474|"     The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24     weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1     hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients   "
130301|NCT01579461|"     The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with     mild and moderate hepatic impairment compared to healthy subjects.   "
130302|NCT01579448|"     Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection     over 3 years and data regarding the protective efficacy over five years is anticipated for     2012. Regardless at the end of five years, it may still be necessary to provide a booster     dose or reimmunize with two doses to maintain protection in previously immunized populations.     This study examines the immune protection and safety of providing a one and two dose boosting     regimen of Shanchol™ given five years after the initial dose.   "
130303|NCT01579435|"     The purpose of this study is to determine whether transcranial direct current stimulation     (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to     identify the cerebral mechanisms involved in these potential effects.   "
130304|NCT01579422|"     The primary aim of this proposal is to develop, refine, manualize and assess the feasibility     and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for     individuals with psychosis. The intervention will focus on helping individuals interpret     social situations, specifically the intentions and feelings of others.      Study methods include preliminary treatment and manual development based on series of     uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly     developed intervention.   "
130305|NCT01579409|"     In France, primary cardiovascular and metabolic prevention is supported by the French     National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé).      The investigators made the hypothesis that, independently of other diseases, the non     adherence in PNNS guidelines would lead to arterial stiffness, endothelial dysfunction,     change in microcirculation and in cardiac autonomic system. These changes may exist at     fasting but also be reinforced after a standardised breakfast.      The investigators aim is to evaluate arterial stiffness, endothelial function,     microcirculation and cardiac autonomic system according to PNNS status in a case control     study.   "
130306|NCT01579396|"     A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with     incidence of systemic inflammatory response syndrome (SIRS) and associated increased risk     for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase     the postoperative IL-6/Il-10 ratio.   "
130307|NCT01579383|"     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of     ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous     injection.   "
130308|NCT01579370|"     Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for     the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant     (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter     study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of     enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of     environmental contamination on acquisition of MDR-pathogens among hospitalized patients.   "
130309|NCT01579357|"     The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on     the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen     is given combined with Oxaliplatin (OxPt).   "
130310|NCT01579344|"     The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid     carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy     and metastases. Although serious complications are uncommon after treatment, there are     well-documented adverse reactions secondary to the involvement of the salivary glands, such     as dry mouth, pain in the parotid glands and dysphagia, even after administration of low     doses of radioiodine. However, ocular complications of such treatment are scarcely reported     in literature.      Among them the investigators can mention recurrent and chronic conjunctivitis,     keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive     iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially     after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction     have been reported as complications associated with the use of radioiodine, although studies     are not available to assess its true incidence through the systematic evaluation of patients.      It can be seen in routine practice that these patients would normally be referred for     ophthalmological examination only if a complaint, what happens in the process of OVL already     installed after the use of high doses of radioiodine. With the early evaluation of these     patients, the investigators focused on detecting the process of ongoing obstruction in order     to study interventions that prevent its final installation.   "
130313|NCT01579305|"     The purpose of this study is evaluate lip fullness 3 months following treatment with     Juvéderm® Volbella with Lidocaine or Restylane-L®   "
130314|NCT01579292|"     The goals of the study are to:        1. Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary          intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to          a control group.        2. To explore the association between low heath-literacy levels at baseline and adherence          to mobile phone usage.        3. To conduct process evaluation to gain insights into patient compliance to the mobile          intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months          using a semi-structured interview method.   "
130315|NCT01579279|"     To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic     neuropathic pain. People with diabetes can, over time develop nerve damage throughout the     body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms,     feet and legs.   "
130316|NCT01579266|"     Background:      - People with writer s cramp develop tightness in arm muscles and abnormal hand posture when     writing, which makes writing difficult or impossible. At present, there is no suitable rating     scale to measure the symptoms of or disability associated with writer s cramp. Researchers     want to videotape people performing simple writing tasks. They will then compare the     performance of people with writer s cramp on these tasks to those of people without writer s     cramp. This information will help develop a rating scale to evaluate writer s cramp.      Objectives:      - To develop a new rating scale for writer s cramp.      Eligibility:      - Individuals at least 18 years of age who have writer s cramp.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have one outpatient study visit that will last about 3 hours.        -  Participants will perform tasks related to writing, such as writing passages and drawing          spirals and loops. They will be videotaped during these tasks. They will repeat some of          the writing tasks three more times; on paper attached to a writing tablet, directly on          the writing tablet, and on a computer tablet.        -  The angles made by the joints will be measured at rest not while writing      healthy volunteers.   "
130317|NCT01579253|"     Patients with recurrent glioblastoma who are planned to receive a second course of radiation     are to be included into this monocentric cohort trial. Due to multiple pre-treatments     simultaneous combined positron emission tomography (PET) with     O-(2-[18F]fluoroethyl)-l-tyrosine (FET) as well as magnetic resonance imaging (MRI) is used     for treatment planning and follow-up imaging as it allows for a better distinction between     treatment-related changes and viable tumor tissue.   "
130318|NCT01579240|"     This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older     adults adopt and maintain an exercise regimen. A total of 368 men and women over 55 years of     age (x = 60.3; SD 4.9 ) were recruited and screened on line. They randomized into treatment     and control groups and assessed at pre-test, 12 weeks, and at six months.      The multivariate model was significant at posttest (p = .001; large effect size) and at six     months (p = .001; medium effect size). At posttest, intervention participation showed     significant improvement on 13 of 14 outcome measures compared to the control group. At six     months, treatment group participants were found to maintain large gains compared to the Ctrl     participants on all 14 measures.   "
130319|NCT01579227|"     The following two objectives are proposed in healthy subjects to characterize (1) wound     closure, (2) scar formation/appearance, and (3) inflammatory response:      Objective 1, (topical only - referred to as TOP) - Topical application of Tocotrienol (TCT)     vs placebo in bilateral punch biopsy      Objective 2, (oral and topical - referred to as OTOP) - Combined oral supplementation and     topical application of tocotrienol (TCT) vs placebo in bilateral punch biopsy      Objective 3, (topical only - referred to as TAM) - Topical application of tamoxifen vs     placebo in bilateral punch biopsy.      Objective 4, (topical only to normal skin) - Topical application of TCT vs placebo on     bilateral lets on normal skin.   "
130320|NCT01579214|"     The investigators will study the efficacy of a novel cellular phone messaging system to     communicate health information and facilitate early return to clinic after abnormal     laboratory results in rural Uganda.   "
130323|NCT01579175|"     The investigators are randomizing patients to receive chewing gum (Extra Sugar Free,     Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative     care. The investigators then have them fill out a survey in house and 1 week after their     surgery that record time to first flatus, hunger, toleration of clear liquids and food and     some information about pain, satisfaction, and quality of life. The investigators contact     them via phone and email a maximum of three times in order to collect this information. 30     days postoperatively the investigators also contact them and perform a chart review for any     postoperative complications.   "
130324|NCT01579162|"     HepQuant tests are new liver tests that are being developed to accurately measure liver     function with sensitivity and specificity while being safe and non-invasive. The primary goal     of this study is to define the intra-individual reproducibility of the HepQuant tests, that     is, to see if a person is given the tests several times that the test results are essentially     the same each time. Subjects for this study will include healthy controls and patients with     chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV)     infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis     (NASH). The HCV and NASH patients will include men and women, and those with early stage and     late stage liver disease as defined by the amount of fibrosis observed in their liver     biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests     on three separate days within the span of one month. The hypothesis of this study is that     HepQuant tests will reproducibly report liver function in healthy controls and patients with     all stages of chronic HCV and NASH liver disease and that liver function will decrease as the     amount of liver fibrosis increases in the chronic liver disease patients.   "
130325|NCT01579149|"     The primary objective is to assess the pharmacokinetics of 3 dose levels of plerixafor     injection (160 μg/kg, 240 μg/kg, and 400 μg/kg) in healthy adult subjects of Japanese     descent. Three cohorts of subjects will be enrolled. Approximately 8 subjects will be     enrolled in each cohort, 6 subjects who will receive a single subcutaneous (SC) dose of     plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), and 2 subjects who will receive a single SC     dose of placebo. The lowest dose-level cohort (plerixafor 160 μg/kg) will be fully enrolled     first, followed by the next highest dose-level cohort (plerixafor 240 μg/kg), and finally the     highest dose-level cohort (plerixafor 400 μg/kg), provided safety criteria for dose     escalation are met.   "
130331|NCT01579071|"     Insufflation is essential procedure to observe the lumen of gastrointestinal tract in     gastroscopy or colonoscopy Currently, most of hospital in Korea are using room air for     insufflation According to recent clinical studies have shown that carbon dioxide have better     safe and reduce stomachache than room air when endoscopy and endoscopic procedure is     performed.      However, there was still no research data or study in Korea. In this study, the investigators     will try to make comparison between Carbon dioxide and room air insufflation for endoscopic     submucosal dissection for Gastric Tumor and investigate the efficacy and safety   "
130332|NCT01579058|"     Aortic stenosis has been thought to be a degenerative process basically induced by     long-lasting mechanical stress, and hemodynamic factors such as shear forces, acceleration of     blood flow, hypertension and rapid heart rate might contribute to progression of aortic     stenosis. Peak aortic jet velocity is known to be associated with clinical outcomes in mild     and moderate AS, and our previous study showed that rate of progression was significantly     associated with baseline aortic jet velocity in mild aortic stenosis. Because beta-blocker     therapy would decrease aortic jet velocity and heart rate, it might decrease hemodynamic     stress and eventually slow down the degenerative process in patients whose disease is not too     advanced for therapy to be effective. The investigators hypothesized that a beta-blocker     therapy would decrease the rate of progression of aortic stenosis by modifying hemodynamic     factors favorably in patients with mild to moderate aortic stenosis.   "
130333|NCT01579045|"     Primary Hypotheses:      Senofilcon A will provide significantly less rotation with subjects in a recumbent position     than Filcon II 3 monthly .      Etafilcon A will provide significantly less rotation with subjects in a recumbent position     than Filcon II 3 1 1 day .      Etafilcon A will provide rotation with subjects a recumbent position non-inferior to     nelfilcon A. A margin of 5 degrees will be used.      Secondary Hypotheses:      Senofilcon A will have significantly better monocular visual performance with subjects in a     recumbent position than Filcon II 3 monthly.      Etafilcon A for astigmatism will have significantly better monocular visual performance with     subjects in a recumbent position than Filcon II 3 1 day.      Etafilcon A will have monocular visual performance with subjects in a recumbent position     non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.   "
130334|NCT01579032|"     The aims of the presented study are as follows:        1. To evaluate the endothelial function and arterial stiffness in a large cohort of          prevalent CKD patients by means of non-invasive applantion tonometry.        2. To evaluate the association between the serum levels of the representatives of the          various classes of uremic toxins and markers of endothelial function and arterial          stiffness.        3. To evaluate the association between markers of inflammation and oxidative stress and          markers of endothelial function and arterial stiffness.        4. To evaluate the association between echocardiographic parameters and markers of arterial          stiffness   "
130335|NCT01579019|"     This randomized, double blind, phase II study will evaluate the efficacy and safety of two     doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys     (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease     inhibitor containing regimen with or without pegylated interferon. Patients will be     randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice     daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or     1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with     danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys     and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with     danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study     treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.   "
130336|NCT01579006|"     This multi-center, observational study will evaluate the clinical practice patterns, efficacy     and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an     inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one     biological agent. Data will be collected from each eligible patient initiated on     RoActemra/Actemra treatment by their treating physician according to approved label for 6     months from start of treatment.   "
130337|NCT01578993|"     The purpose of this study is to determine the rate and timing of interventions and     complications related to the use of peripherally inserted central venous catheters in adult     patients.   "
130338|NCT01578980|"     A single arm, single treatment study is proposed to assess the feasibility of the AP Platform     (cell phone + Control to Range system) outside of a hospital based clinical research center.   "
130339|NCT01578967|"     The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4     chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of     cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In     addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive     radiation therapy. The use of chemotherapy and radiation may cause long term treatment     related side effects such as heart problems and other cancers. Researchers are trying to find     if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy     cycles given is just as effective as the standard Hodgkin treatment.      Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for     the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the     use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational.     Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it.     Antibodies are proteins that are part of your immune system. They can stick to and attack     specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target     called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some     cancer cells and some normal cells of the immune system.      The purpose of this research study is to see the effects of treatment with fewer cycles of     the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on     study participants and Hodgkins lymphoma.   "
130399|NCT01578187|"     The purpose of this study is to test label comprehension and usability of the hair removal     device in 60 male and female participants. The study population will represent the US     demographic distribution of skin types and will include varying levels of literacy.   "
130400|NCT01578174|"     The investigators examined the effect of dexmedetomidine in the management of pain after     uterine artery embolization.   "
130340|NCT01578954|"     The purpose of this research study is to test the safety of the study drug, lenalidomide, at     different dose levels in people diagnosed with acute myeloid leukemia (AML) who have finished     standard induction therapy and have had a partial or complete response to induction therapy.     The investigators want to find out what effects (for example, side effects) the study drug,     lenalidomide, has on people and their leukemia. The investigators also want to see if     additional treatment (maintenance therapy) with lenalidomide will keep the leukemia from     relapsing (coming back).   "
130341|NCT01578941|"     The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg)     taken at the first onset of menstrual migraine will both terminate the acute headache and     assist in preventing headache recurrence and the need for repeat abortive therapy over the     ensuing days of menses.   "
130342|NCT01578928|"     The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics     (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal     impairment.   "
130343|NCT01578915|"     Both population based surveys and more focused research studies indicate that increased     numbers of sexual partners and partner concurrency contribute to increased risk for     acquisition of sexually transmitted infection (STI), including HIV infection. However, unlike     for men, both national and sub-population-based studies consistently find that the great     majority of women with or without STIs report only 1-2 sex partners in the preceding year and     that a minority of women acknowledge > 3 sex partners over the same period, suggesting that     this relatively small proportion of women with higher numbers of sex partners play a     disproportionate role in sustaining community STI rates. Despite these observations,     surprisingly little is known about women with increased numbers of sexual partners, the     factors which contribute to increased partner number, and the potential for those factors to     be intervened upon to reduce risk for STI. The implications of these facts for STI/HIV     prevention efforts are profound. For instance, interventions that include the implication     that target audiences have multiple sex partners might be dismissed as irrelevant by those     with single partners. Conversely, interventions targeting women with multiple sex partners     may be based on assumptions derived from data which, while representative of the general     target audience, may not reflect relevant circumstances for the subset of women with higher     numbers of partners.      This study will begin to generate data that will provide critical information on this topic     and help inform future development of STI/HIV interventions tailored to womens' individual     circumstances and contexts. The investigators hypothesize that women with 4 or more sexual     partners during the past year will report higher rates of depression and substance abuse     (alcohol and drugs), higher rates of intimate partner violence, less social support, more     non-vaginal sex, more same-sex contacts, and higher rates of STIs than women reporting only     one sexual partner during the past year.   "
130344|NCT01578902|"     The purpose of this study is to determine the safety and efficacy of a short course of     radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.   "
130345|NCT01578889|"     Some vaccines may work better when given together with another substance known as an adjuvant     or when given with an experimental procedure called electroporation (EP). EP is a method     where an electric pulse is administered to the same muscle where the vaccine injection is     given. The addition of the adjuvant to the vaccine and the delivery with EP may increase a     person's immune response to the vaccine. Combination approaches such as a DNA vaccine     followed by live vector boost may also increase a person's immune response to the vaccine     components. All of these interventions will be tested in this study.      This study will evaluate the safety and tolerability of and immune response to an HIV DNA     vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live     vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.   "
130346|NCT01578876|"     The purpose of this study is to determine the effectiveness of cardiac shock wave therapy     (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.   "
130347|NCT01578863|"     The child health and sports center, at the Meir Medical Center, runs for over 10 years an     intervention program to treat obese children. The program includes physical activity,     nutritional intervention and behavioral treatment. A similar program exists in the nearby     city of Hadera. The aim of the programs is to promote weight loss, encourage physical     activity and modify behavior in order to get long term results. The aim of the present study     is to try and identify the demographic and behavioral characteristics of children who succeed     in the program.   "
130348|NCT01578850|"     To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly     plus methotrexate with or without other disease modifying antirheumatic drugs therapy with     that of methotrexate with or without other disease modifying antirheumatic drugs therapy at     Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved     low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly     plus MTX with or without other disease modifying antirheumatic drugs therapy.   "
130349|NCT01578837|"     The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind     randomized placebo controlled trial. The objective is to investigate whether the combination     of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are     effective and safe in the long-term management of high blood pressure while managing type 2     diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key     inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.   "
130350|NCT01578824|"     Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in     exhaled breath condensate in vitamin D resistant rickets.      Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and     inflammatory mediators in exhaled breath condensate in a prospective study evaluating     patients with vitamin D resistant rickets and in healthy controls.      Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as     assessed by methacholine challenge test.      Secondary outcome parameters: All other parameters are the secondary end points.   "
130351|NCT01578811|"     The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With     acute and chronic gastritis.   "
130352|NCT01578798|"     Surgical trauma triggers a massive inflammatory response. Over time, both the innate and     adaptive branches of the immune system are affected by surgical trauma. The purpose of this     study to characterize the cellular and molecular mechanisms immune response to surgical     trauma. Additionally, detailed information about patients' recovery profile will be recorded     over a period of 6 weeks, with the eventual goal of linking immune responses to recovery     profiles.   "
130353|NCT01578785|"     This study will investigate the efficacy, safety and tolerability of a new formulation of     glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with     Relapsing-Remitting Multiple Sclerosis (RRMS).   "
132337|NCT01552798|"     The purpose of this trial is to determine if a single, oral dose of a fast release aspirin     1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with     tension-type headache pain.   "
130354|NCT01578772|"     This research study is to see whether blood vessel function, an early sign of heart disease,     improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators     will be looking at how a blood vessel in the arm, called the brachial artery, changes in     response to stress before and after taking telmisartan. To determine how well the blood     vessel functions, the investigators will be using an ultrasound machine.      Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat     blood pressure, but has been shown to improve blood vessel function in HIV-negative people     with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this     trial is sponsored by The Campbell Foundation.   "
130355|NCT01578759|"     The purpose of this study is to assess the feasibility of performing a randomized clinical     trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during     laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes     can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled     tubes)and additional invasive procedures such as further imaging work-ups and further surgery     related to the tubes.   "
130356|NCT01578746|"     In total hip arthroplasty several approaches can be used. The newly introduced minimally     invasive anterior approach is supposed to cause less damage to tendons and muscles. At the     same time there are reports that there are more complications when this approach is used. The     direct lateral approach is the most used in Norway and is well documented. There are however     those who postulate that there is to high risk of damage to the gluteus medius causing     Trendelenburg gait. In the investigators hospital both the anterior and direct lateral     approach is used with good result. The investigators main study hypothesis is that there is     no difference between the use of anterior or direct lateral approach i total hip arthroplasty     in regards to postoperative function and pain, complications, radiological finds (X-ray and     MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.   "
130357|NCT01578733|"     Minimal data are available on protein requirements throughout the lifespan. Currently     available recommendations are based on nitrogen balance data. The limitations of the nitrogen     balance method have been well described. Importantly, nitrogen balanced underestimates     requirements.      The current DRI requirement for healthy adult males is based on the reanalysis of the     nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by     Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83     (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group     estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2     g/kg/day (mean and RDA).      Currently there are no studies on protein requirement in the elderly. In a recent nutrition     survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70     years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents     about 15 % of calories. Depending on the calculations used for ideal body weight some older     adults could be getting higher or lower than requirement. There is no scientifically derived     protein estimate for older adults. Therefore there is a need to measurer protein requirement     in that population.      The goal of this study therefore is to measure the protein requirement of female elderly     subjects between the ages of 65 - 70 years using the IAAO technique.   "
130358|NCT01578720|"     The purpose of this study is to assess the efficacy and safety of intravitreal injection of     aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed     ocular histoplasmosis syndrome (POHS).   "
130360|NCT01578694|"     Magnetic resonance imaging (MRI) is one of the best ways to image articular cartilage. One of     the techniques which has shown great promise is the imaging technique called T1ρ (T1-rho).     T1ρ is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.     Because the initial phases of arthritis occur at the molecular level, the main advantage of     the T1ρ pulse sequence is that it is sensitive to proteoglycan. Proteoglycan is a molecule     that is important to cartilage structure, and is lost as osteoarthritis develops. If we can     show that this non-invasive tool can accurately assess cartilage damage and levels of     proteoglycan, the clinical applications are numerous. The results can potentially help     determine optimal surgical techniques and timing of surgical intervention to halt or slow the     progression of arthritis, and will assist in the study of the effects of FAI and the success     of the surgery performed to correct FAI.   "
130361|NCT01578681|"     The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.      Primary objective:      -To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to     placebo.      Secondary objectives:        -  To evaluate the level of knowledge of airway clearance techniques and adherence to them          in patients with bronchiectasis.        -  To assess the side effects during the procedure: oxygen desaturation, increased dyspnea          and hemoptysis.   "
130362|NCT01578668|"     The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are     effective and safe in treating lung adenocarcinoma with brain metastases.   "
130363|NCT01578655|"     This Phase 3 study has been designed to confirm that adding custirsen to     cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes     compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate     resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter,     international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs.     cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal     probability to the two arms.   "
130364|NCT01578642|"     The EndoStim Stimulation System is an investigational device intended to improve the lower     esophageal sphincter (LES) resting tone and restore LES function in individuals suffering     with gastroesophageal reflux disease (GERD).   "
130365|NCT01578629|"     A natural form of vitamin E called tocotrienol (TCT), found in many common foods such as     barley, decreases stroke size in animal models. Vitamin E has blood-thinning properties and     lowers cholesterol, which make it a potential therapy for stroke prevention, though these     effects are less well characterized for TCT. We plan to conduct two trials (I & IIA) to     determine the effects of orally supplemented TCT on platelet function and cholesterol.   "
130465|NCT01577316|"     The hypothesis proposed in this study is that the 2011-2012 Seasonal Influenza Vaccine     (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to     15ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.   "
130366|NCT01578616|"     Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability.     The high resolution of optical coherence tomography (OCT) provides an accurate measurement of     fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and     digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic     and quantitative method to evaluate endothelial function. The investigators will investigate     the association between endothelial function assessed by RH-PAT and plaque vulnerability     determined by OCT-derived thin-cap fibroatheroma (TCFA).   "
130367|NCT01578603|"     The purpose of this study is to determine the effect of three times a day mastication, during     a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors     associated with dental caries and gingivitis.   "
130368|NCT01578590|"     Rationale: The consumption of dietary protein immediately after exercise is necessary to     maximally stimulate muscle protein synthesis rates (24, 37). Recent work suggests that the     type of protein consumed (e.g., animal vs. plant-derived proteins) during post-exercise     recovery can affect the amplitude of acute increases in muscle protein synthesis rates (25,     31). Specifically, consumption of bovine milk proteins immediately after a single bout of     resistance exercise stimulates muscle protein synthesis rates greater than consumption of an     isonitrogenous soy-protein beverage (31, 37). Importantly, consumption of milk promotes     greater hypertrophy than soy after resistance training (10). Thus, it is generally assumed     that the acute muscle protein synthetic response predicts long-term training outcomes, such     as hypertrophy. Currently, a great amount of work has been carried out to study the effects     of consuming milk proteins on muscle protein synthesis rates after resistance exercise (5, 7,     26, 32). However, very little is known about the effects of other types of high-quality     animal proteins, such as beef, on stimulating post-exercise muscle protein synthesis rates.     Further describing the muscle protein synthetic response after consumption of other types of     high-quality animal proteins will provide valuable information for individuals with milk     allergies, lactose intolerance, or simply a strong dislike of dairy products.      Objective: To investigate whether the in vivo post-resistance exercise muscle protein     synthetic response is augmented when minced beef is ingested as compared to an     isonitrogenous-matched milk protein beverage in healthy young men.      Study design: Crossover, randomized      Study population: 12 healthy young males (18-35 y).      Intervention: Subjects will perform resistance exercise and consume either a piece of meat     (135 grams, 35 g of protein) or an isonitrogenous-matched milk protein beverage on two     separate test days. In addition, continuous intravenous tracer infusions will be applied,     with plasma and muscle samples collected. A two week 'wash-out' period will be included     between trials.      Main study parameters/endpoints Primary endpoint: Muscle protein synthetic rate, expressed as     fractional synthetic rate (FSR). Secondary endpoints: Rate of protein digestion and     absorption and whole body protein balance.   "
130369|NCT01578577|"     Many patients have difficulty performing routine medication management tasks. Individuals     with limited literacy are at high risk for these problems. The overall study objective is to     rigorously evaluate two primary care-based medication therapy management strategies that     leverage an electronic health record (EHR) to promote patient understanding, medication     reconciliation, medication adherence and disease control among hypertensive patients at     safety net clinics.   "
130370|NCT01578564|"     The purpose of this study is to determine the safety and tolerability of the drug SOR-C13     when given as an intravenous infusion in patients with ovarian cancer or other cancers known     to over express the TRPV6 calcium channel.   "
130371|NCT01578551|"     To determine the 1 year progression-free survival (PFS) of the combination of metformin and     standard chemotherapy in patients with previously untreated advanced or metastatic pulmonary     adenocarcinoma.   "
130372|NCT01578538|"     Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective     complications.   "
130373|NCT01578525|"     The purpose of this study is to determine whether additional pharmaceutical care for elderly     patients (home-cared patients, nursing-home residents) has a positive impact on drug-related     readmissions.   "
130374|NCT01578512|"     The purpose of this study is to determine the best format for delivering a brief behavioral     weight loss intervention to young adults 18-25 years of age.   "
130375|NCT01578499|"     This is a Randomized, Open-Label, Phase 3 trial of brentuximab vedotin(SGN-35) Versus     Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous     T-Cell Lymphoma   "
130376|NCT01578486|"     This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15     schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive     functioning, and metabolic parameters.      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or     Massachusetts General Hospital. A total of 15 subjects will be enrolled.   "
130377|NCT01578473|"     Two recent studies have identified low levels of serum testosterone in association with     Peyronie's Disease (PD), with a significant correlation noted between severity of     testosterone deficiency and severity of curvature. The study hypothesis is to determine     whether treatment with testosterone may help men with PD and penile curvature.   "
130378|NCT01578460|"     Poor glucose control during pregnancy is a significant concern for Canadian women with     diabetes. This problem is magnified in First Nations women, who have among the highest rates     of gestational diabetes (GDM) in the world (up to 18% of First Nations women will develop GDM     during pregnancy and 70% of these will go on to develop type 2 diabetes later). Continuous     glucose monitoring (CGM) technology has the potential to help women maintain tighter control     during pregnancy, however, in the First Nations population, there are many unique barriers     that may affect use of this technology. Such barriers include remoteness of the community,     cultural apprehension, lack or difficulty of access to care, and language differences.      A total of 60 participants from three participating First Nations communities in Southern     Ontario will participate in the study. Participants will self-select to either the CGM group     (n=30) or the control group (n=30) after consenting to participate in the study. Participants     in both groups will be asked to monitor their blood glucose for 5 days for the 28th, 32nd and     36th week of gestation. Primary outcomes to be evaluated include maternal A1c and offspring     birth weight. To assess the feasibility and acceptability of CGMs among First Nations women,     a questionnaire will be distributed to participants to gather insight into their rationale     for enrolling into either group. Recruitment rates for both groups will also be used to     assess feasibility and acceptability of CGMs. Additionally, all participants will be     encouraged to participate in a community lifestyle program consisting of 30-min exercise     sessions offered five days a week. The community lifestyle program will be adapted to the     community, linked to existing programs with support from program personnel and will include     educational sessions related to diabetes and healthy lifestyles. It is hypothesized that     through participation in the community lifestyle program, pregnant First Nations women with     diabetes will experience a decrease in their blood glucose values post-exercise, mitigate     excessive weight gain and normalize their A1c's. It is further hypothesized that an increase     in women's regular physical activity levels, the number of steps taken and knowledge of     diabetes will be observed.   "
130379|NCT01578447|"     The purpose of this study is to assess acceptability and side effects of a low-dose     injectable contraceptive formulation which is delivered under the skin (subcutaneously), as     compared with injectable contraception delivered into the muscle (intramuscularly) among     adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable     contraception. The investigators will also assess experiences experiences delivering these     two types of injections among health care providers working within the HIV care clinics.   "
130466|NCT01577303|"     The purpose of this study is to determine whether different internet-based treatment     programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a     population diagnosed with this disorder.   "
130380|NCT01578434|"     Rickets, a common nutritional disorder, is usually considered to be due to vitamin D     deficiency. However, in the last few decades many studies have shown that in tropical     countries, with abundance of sunshine, calcium deficiency may play a more important role in     the causation of rickets. Studies from adults in India have also shown that calcium intake of     our population is much below the recommended allowance. The calcium deficiency gets     compounded by the high level of phytates in the conventional vegetarian diet consumed by the     majority of the population. There are few studies on children in India / other Asian     countries on assessment of dietary calcium intake.      However, recent studies from many nations of the world have also shown a wide spread     prevalence of vitamin D deficiency in adolescent and adult population. A study done at our     own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and     their infants.      Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not     clear what plays a more important role in the etiology of rickets in India or other Asian     countries.      The present study is therefore planned with the following objectives:        1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children          with and without rickets.        2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the          treatment of nutritional rickets.   "
130381|NCT01578421|"     The purpose of the study is to compare clearance and removal rates of phosphate,     ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during     post-dilution online hemodiafiltration.   "
130382|NCT01578408|"     The purpose of this prospective randomized study is to compare the quality of treatment     between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip     Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.      Our hypothesis is that an uncemented option spares the patient the operative load of the     cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also     perhaps reduces the postoperative cognition strain and improves mobilization parameters.      If the uncemented option has the same excellent fixation in poor bone stock, as in the case     of these osteopenic fractures, and also has the same good clinical outcome, it would be a     viable standard option for the treatment of dislocated femoral neck fractures.   "
130383|NCT01578395|"     Trial with medicinal products      Recent studies revealed that radiation-based procedures in patients may lead to DNA     double-strand breaks in human blood lymphocytes. Additionally, ex vivo studies with human     blood lymphocytes have shown a protective effect of antioxidant agents which have been     described to decrease the number of DNA double-strand breaks.      This study represents a prospective, double-blinded, randomized, single center, and     placebo-controlled phase II clinical trial which analyzes the capability of antioxidant     agents to decrease the number of DNA double-strand breaks in human blood lymphocytes in     patients undergoing radiation-based cardiac examinations (30 patients with high-dose     radiation exposure, 30 patients with low-dose radiation exposure, and 30 subjects without     radiation exposure).      A protective effect of antioxidant drugs in patients undergoing radiation-based examinations     could therefore change patient management and would provide an important clinical impact.   "
130384|NCT01578382|"     Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction)     which occurs in long-term hypertensive subjects.      Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin     infarction) which occurs in subjects with end-stage kidney disease or after kidney     transplantation.   "
130385|NCT01578369|"     To investigate the effect of pelvic floor muscle training taught in a general exercise class     during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.   "
130459|NCT01577394|"     The aim of this study is to determine whether saccadic eye movement recording may help in the     discrimination between Lewy body dementia and Alzheimer disease, in the early stages of the     disease.      Study type: Interventional Study design: Intervention Model: Single group assignment Primary     purpose: Diagnostic   "
130386|NCT01578356|"     For primary surgical treatment of prostate cancer the investigators compare the classic open     surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery     (RALP). Oncological results are obtained at standard follow-up consultations through     Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional     results (continence, potency, quality of life) are obtained through standardised     questionnaires. Currently the investigators perform all of their prostatectomies in a     robot-assisted manner. For results of the open surgery the investigators send questionnaires     to patients who had the operation in the past.   "
130387|NCT01578343|"     1. Rationale In mantle cell lymphoma, the conventional chemotherapy achieves only temporary          responses with a median duration of remissions only from 1 to 2 years. Therefore, mantle          cell lymphoma is known as one of the B-cell lymphomas with poor prognosis. Although the          treatment outcome of mantle cell lymphoma has been improved since intensive chemotherapy          regimens such as HyperCVAD was used, a substantial number of patients are still          frequently relapsed after chemotherapy. After relapse, most of them became refractory to          various kinds of salvage treatment. That is why the results of most salvage chemotherapy          regimens were disappointing. In addition, mantle cell lymphoma generally occurs in          elderly people. Thus, intensive salvage chemotherapy may not be feasible for elderly          patients. Therefore, an effective, novel combination treatment is urgently needed in          relapsed or refractory mantle cell lymphoma patients.        2. Hypothesis             -  Vorinostat will produce synergism with a combination treatment regimen               (Fludarabine, mitoxantrone, dexamethasone, FND) without overlapping toxicity             -  Vorinostat maintenance treatment will reduce the relapse rate in patients               ineligible for autologous stem cell transplantation.        3. Purpose A phase II investigation to determin the effectiveness of vorinostat in          combination with intravenous fludarabine, mitoxantrone, and dexamethasone in patients          with relapsed or refractory mantle cell lymphomain patients with relapsed or refractory          mantle cell lymphoma.   "
130388|NCT01578330|"     The study will assess the patients' satisfaction of treatment after 12 months treatment with     fingolimod It also will assess the tolerability profile of fingolimod in a small population.   "
132349|NCT01552642|"     The overall purpose of this study is to develop and implement an effective intervention     program designed to prevent and treat obesity in young children.   "
130389|NCT01578317|"     Background:      - Adjuvants are substances included in vaccines that stimulate the immune system and increase     the body's response to the vaccine. The MF59 adjuvant is used in seasonal flu vaccines in     Europe. However, it has not been fully tested in the United States. Researchers want to test     the immune responses of people who receive a bird flu vaccine with or without MF59 to better     understand how the adjuvant works. This information may help develop better flu vaccines.      Objectives:      - To compare the healthy immune system responses to bird flu vaccine with or without the MF59     adjuvant.      Eligibility:      - Healthy volunteers between 18 and 45 years of age.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will be assigned to one of two groups. Each group will have an initial          vaccine, followed by a booster vaccine 21 days later. Both vaccinations will use the          same type of vaccine. One group will have the vaccine with MF59; the other group will          have the vaccine without it.        -  All participants will have two 36-hour inpatient stays to receive the vaccine. Each stay          will involve the vaccination, followed by regular and frequent blood draws. Participants          will be monitored for any signs or symptoms that may be caused by the vaccine.        -  Additional blood samples will be collected 7, 28, 42, and 100 days after the initial          vaccination....   "
130390|NCT01578304|"     To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg     b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary     frequency associated with urgency as may occur in patients with overactive bladder.   "
130391|NCT01578291|"     Hypothesis: The use of parent education and medical play will be able to reduce patient     discomfort with potential uncomfortable medical procedures.      Children that have urinary tract infections and those diagnosed with vesicoureteral reflux     undergo a procedure called a voiding cystourethrogram (VCUG) to identify and follow     vesicoureteral reflux. For many children and parents this can lead to considerable distress.     Pre-procedure preparation can potentially reduce anxiety and improve overall experience with     the procedure.   "
130392|NCT01578278|"     This is a clinical study to evaluate the safety and efficacy of a bepotastine     besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic     rhinitis (SAR) in subjects with a demonstrated history of Mountain Cedar pollen allergy. The     primary study objective is to assess the reduction from baseline in averaged morning (AM) and     evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays     (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate     nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For     enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with     placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day     with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for     both nasal and ocular symptoms prior to each dosing.   "
130393|NCT01578265|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fed condition in normal,     healthy, adult, human subjects.   "
130394|NCT01578252|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fasting condition in     normal, healthy, adult, human subjects.   "
130415|NCT01577979|"     In this project, the investigators will develop, implement, and evaluate an adolescent     vaccination quality improvement program, with the program designed to encourage adolescents     to visit their usual primary care provider to receive vaccinations and other recommended     preventive health services. This study will be conducted in different types of primary care     settings, such as public, private, and managed care clinics serving adolescent patients of     diverse backgrounds, and will provide important information to help guide future public     health efforts to achieve high rates of immunization in adolescents.   "
130416|NCT01577966|"     The main purpose of this part of the study is to determine the Central Nervous System     bioavailability of sulfasalazine.   "
130395|NCT01578239|"     The purpose of this study is to        -  compare Progression Free Survival (PFS) after treatment with 177Lu-DOTA0-Tyr3-Octreotate          plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg)          Octreotide LAR in patients with inoperable, progressive (as determined by Response          Evaluation Criteria in Solid Tumors [RECIST] Criteria), somatostatin receptor positive,          well-differentiated neuroendocrine tumours of the small bowel (midgut carcinoid          tumours).        -  compare the Objective Response Rate (ORR) between the two study arms        -  compare the Overall Survival (OS) between the two study arms        -  compare the Time to Tumour Progression (TTP) between the two study arms        -  evaluate the safety and tolerability of 177Lu-DOTA0-Tyr3-Octreotate        -  evaluate the health related quality of life (QoL) as measured by the European          Organization for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 questionnaire        -  explore the correlation of toxicity outcomes and administered radiation doses corrected          for body weight and body surface area        -  explore the correlation of clinical efficacy outcomes with the levels of the biomarkers          Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine        -  evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients        -  explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake          score        -  explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase          (AP)   "
130396|NCT01578226|"     Infections are frequent life-threatening events in patients with cirrhosis, occurring at     least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among     cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no     clear-cut clinical and biochemical features are helpful in diagnosing and prognostically     stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker     presenting high sensibility and specificity in diagnosing bacterial infections in different     clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and     prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.   "
130401|NCT01578161|"     After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many     cases of agiation (over 80%) and despite of no report of long-term complication, agitation is     a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for     prevention of agiation of preschool aged children. The investigators expect single injection     of dexmedetomidine lead to decrease postoperative agitation and pain without any complication     like oculocardiac reflex requiring atopine for treatment.   "
130402|NCT01578148|"     The purpose of this study is to validate the efficacy of Noxipoint(TM) therapy on chronic     pain, and compare it with standard physical therapy using electrical stimulation on patients     with chronic pain.      Invented by Dr. Charlie Koo at Stanford University, Noxipoint Therapy is a specific procedure     with precise location, duration and intensity of TENS stimulation within the general FDA     guidelines. The therapy substantially relieves general muscular/tendon pain and persistently     restores the muscle and tendon function. The surface locations of nociceptors at the free     nerve ending (i.e., Noxipoints) are focused on in the stimulation therapy. Multiple     clinical uses of Noxipoint Therapy confirmed the consistent efficacy of such stimulation at     Noxipoints. An observational study of Noxipoint therapy within the FDA-approved use of TENS     demonstrated an encouraging 93% success rate in eliminating the chronic pain, such as frozen     shoulder pain, within 2-3 sessions. It is an order-of-magnitude improvement over the     non-specific application of TENS and any other modalities in pain treatment. A unique     neuro-immuno-signaling pathway that implicates the activation of adult stem cells, such as     satellite cells in muscles, is implicated based on such a high success rate.   "
130403|NCT01578135|"     This study is conducted in Europe. The aim of the study is to describe the patient population     and therapeutic practices (study phase I), assess efficacy on growth and adult height and     assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)   "
130404|NCT01578122|"     Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal     deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its     prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying     30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely     to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS     may be difficult to apply and to wear.      ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more     comfortable. This could favor a better compliance.      CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS     applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of     targeted pressure at the ankle   "
130405|NCT01578109|"     This pilot clinical trial studies the side effects of sorafenib tosylate before and after     donor bone marrow transplantation in treating patients with acute myeloid leukemia. Sorafenib     tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth.   "
130406|NCT01578096|"     The primary aims of this study are to:        1. Tailor a diabetes stress management intervention for delivery by community health          workers (CHWs) serving an urban Latino population.        2. Investigate the efficacy of the stress management intervention on glycemic control.           Secondary aims of this study are to:        3. Investigate the efficacy of the stress management intervention on stress hormones,          psychosocial functioning, and stress-glucose reactivity.      Study hypothesis:      A CHW-led group-based diabetes education model enhanced with stress management education will     improve glycemic control more than CHW-led group-based diabetes education alone.   "
130407|NCT01578083|"     The investigators overall research hypothesis is that systemic chemotherapy induces     structural changes in the white matter of the brain as demonstrated with Diffusion Tensor     Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated     by resting-state functional connectivity MRI (rs-fcMRI). The investigators believe these     structural and functional changes are responsible for the cognitive symptoms associated with     chemotherapy-induced cognitive impairment (CICI).      The Specific Aim for this study is:      To assess the impact of chemotherapy on structural white matter as defined by DTI and     functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer     survivors with self-reported CICI to breast cancer survivors without CICI.      Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have     abnormal structural connections characterized by DTI-defined disruptions in fractional     anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized     by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without     self-reported CICI.   "
130408|NCT01578070|"     The purpose of this study is to show that ViscoGel® is safe when administrated alone and as     an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the     quantitative and qualitative effect on the immune response.   "
130409|NCT01578057|"     The purpose of this research study is to understand if there is any difference in the effects     of tasimelteon when it is taken alone or in combination with alcohol. This research study is     also being done to understand if there is any difference in the amount of tasimelteon (and     its breakdown products) or alcohol in the blood when taken alone or together. Finally, the     study will also look at the safety and tolerability (how acceptable it is) of tasimelteon.   "
130431|NCT01577771|"     This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal     conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso.     Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and     9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be     assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age     will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart.     Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later.     Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA     assessments pre-vaccination and 1 month post-vaccination.      The immunogenicity and reactogenicity of PCV13 in the standard schedule groups (e.g. 6, 10,     14 weeks for infants and single dose for toddlers) will be compared to that observed in the     PCV13 licensure trials. Within each age group the alternative schedule will be compared to     the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage     (infants only).   "
130410|NCT01578044|"     Atrial fibrillation is common and increases the risk of clotting especially in patients with     multiple clotting risk factors. Patients treated with warfarin, an oral anti-coagulant,     require frequent lab monitoring and dose adjustments and are managed in pharmacy staffed     anti-coagulation clinics that routinely contact them to remind them about blood draws,     re-enforce medication adherence, and adjust dosing based on labs.      Dabigatran, a newly approved medication that may be better for some with atrial fibrillation     to lower risk of stroke and clotting, has been found to have fewer drug problems and     eliminates lab monitoring need. Following instructions for taking dabigatran is important     because it is a twice daily medication requiring monthly refills. Rivaroxaban is a once     daily, newly approved Factor Xa inhibitor oral medication, prescribed to reduce risk of     stroke and systemic embolism among patients with atrial fibrillation. Apixaban is a twice     daily, FDA approved Factor Xa inhibitor oral anticoagulant, prescribed to reduce the risk of     stroke and blood clots among patients with atrial fibrillation. In a double-blind RCT,     apixaban was found to be superior to warfarin in reducing stroke, systemic embolism, and     death. Patients on dabigatran, rivaroxaban, and apixaban will not be followed in     anti-coagulation clinics, therefore will not benefit from the support provided by these     clinics.      It's anticipated many patients will be switched to dabigatran, rivaroxaban, or apixaban     following recent publication of criteria for dabigatran use from the VA National Pharmacy     Benefits Management Program, providing an opportune time to conduct the proposed adherence     study. We will conduct qualitative interviews with patients(n~30) and pharmacists(n~20) to     understand barriers/facilitators to oral anticoagulant adherence. Informed by the findings,     we will develop and pilot test a multi faceted intervention to improve adherence among     patients recently started on dabigatran/rivaroxaban/apixaban.      Specific study aims:        1. Conduct interviews with a sample of patients (n=30) recently started on dabigatran for          atrial fibrillation to determine why patients do or don't take medications        2. Conduct interviews with pharmacists (n=20) in anti-coagulation clinics in order to          understand their opinions why patients do or don't take medications        3. Informed by interviews, develop and test an intervention targeting patients/pharmacists          to improve adherence to dabigatran/rivaroxaban/apixaban   "
130411|NCT01578031|"     The investigators' overall goal is to compare the effect of CPAP treatment on intermediate     cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea     (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative     data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups     will have comparable improvements in daytime sleepiness, but that the cardiovascular and     metabolic improvements following CPAP therapy will be decreased in OSA patients with     increased visceral adipose tissue. The investigators anticipate that, although there will be     a greater absolute change in markers of sympathetic activity, inflammation and oxidative     stress in obese compared to lean OSA patients following CPAP treatment, the levels will still     be abnormally high in the obese patients resulting in the decreased improvements in insulin     resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients.   "
130412|NCT01578018|"     DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem     cells in colonic crypts. Mutations within the stem cell population are thought to be     responsible for the development of most colorectal carcinomas and studies have shown that     DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development     of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung     cancers.      The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with     suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking     status.   "
130413|NCT01578005|"     Coronary angioplasty is rather frequently performed in such situations, presumably because,     changes in the atherosclerotic plaque under drug treatment, have remained poorly described so     far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma,     better than the one provided by coronary angiography.   "
130414|NCT01577992|"     Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by     autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype)     or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it     ended with the patient's death few years later. No neuroprotective treatment has shown a real     efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The     origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication     of dopamine neuromediator pathway in integration and modulation of pain. Several studies     suggest the existence of various influences with dopamine implication in the appearance of     painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA     and PD could be due to a decrease of pain appearance threshold, secondary to a lost of     control of sensitizes centres, to Parkinson control.      It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold     and to characterise the levodopa effect on the patient's pain threshold. Better     physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care.     Because the efficacy of others treatments is low, it's important to improve the research for     a better comfort of patients with a better understanding, analysing and treating of the pain.   "
130429|NCT01577797|"     This Phase I, randomized, 22-day crossover study seeks to improve treatment outcomes for     methamphetamine-dependent subjects by developing a cognitive behavioral therapy (CBT)- based     short message service (SMS) text messaging intervention as an adjunct to CBT group therapy.   "
130460|NCT01577381|"     The purpose of this study is to determine the efficacy, safety and tolerability of multiple     doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular     Degeneration.   "
130417|NCT01577953|"     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of     the immune system caused by cytokine production. A substantial number of asthma patients do     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for     novel targeted therapies with improved specificity, tolerability, and compliance.      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting     early disease-causing mechanisms are a promising approach for the treatment of asthma. The     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and     has been shown to be necessary and sufficient for the production of cytokines interleukin     (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product     SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the     10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).      DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic     acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and     thereby reduces key features of allergic airway inflammation. DNAzymes are generated     completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP)     controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by     use of any living organism including cell culture or bacteria. The molecules are highly     water-soluble and will be applied as solution directly in their synthesized form.      The current study will evaluate the safety and tolerability of increasing single doses of     inhaled SB010 in male patients with asthma who have airway hyperresponsiveness(demonstrated     by methacholine bronchial challenge test).   "
130418|NCT01577940|"     The purpose of this method study in healthy volunteers is to determine the extent of sensory     block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine     versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block     and the influence on the lung function.   "
130432|NCT01577758|"     This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult     Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.   "
130419|NCT01577927|"     Patients at high complexity with severe chronic diseases can require several admission in     intensive care units (ICU) to overcome acute exacerbations by the use of assisted     ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of     patients often needing weaning procedures due to a long-lasting period of mechanical     ventilation. These patients are often under chronic conditions with recurrent symptoms,     reduced effort tolerance and depression.      Weaning process is a frail step in the medical history of a patient who has survived an acute     episode of respiratory failure and has spent a period of time under mechanical ventilation.     Patients are followed for the duration of in-hospital stay, an expected average period of 4     weeks.      When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is usually     managed by GPs and by the hospital where he has been admitted to following re-exacerbations.     The conventional approach is for sure inadequate for this type of patient whose clinical     complexity, disability and frailty need for a continuity of care through a higher complex     approach of management.      A structured program of Home Rehabilitation could be a possible solution to this problem.     Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy     of a home rehabilitative network for prolonged weaned patients discharged from a weaning     unit.   "
130420|NCT01577914|"     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence     between Test Product and the corresponding Reference Product under fasting condition in     normal, healthy, adult, human subjects.   "
130421|NCT01577901|"     Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue Advanced     Pregnancy test, following the instructions for use. The test will be conducted following both     the instructions for the in stream method of sampling and the method of testing when a sample     is collected into a container. The results will be compared to those achieved by the study     technician.   "
130422|NCT01577888|"     To study the early safety and performance of the Shockwave Medical System in subjects to     demonstrate that the device can safely and effectively deliver localized energy for the     treatment of vascular disease.   "
130423|NCT01577875|"     The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow     band imaging.   "
130424|NCT01577862|"     Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with     high lethality in hospitalised critically ill patients. It can acquire resistance to all     classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may     be the only therapeutic option. However, colistin is not registered for this indication. The     addition of rifampicin to colistin has been shown to be synergistic in vitro, and may be     promising in vivo, but this combination has not been studied in comparison with colistin     alone.      The purpose of this randomised, open-label, multicentre clinical trial is to assess whether     the association of colistin and rifampicin reduces significantly the mortality of patients     with severe MDR A. baumannii infections compared with colistin alone.      The trial will enroll 210 patients from intensive care units (ICU) of five tertiary care     hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be     randomly allocated to either colistin alone (control arm) or colistin plus rifampicin     (experimental arm).      Primary end point is overall mortality, defined as death occurring within 30 days from     randomisation.      Secondary end points will be disease-specific death, microbiological eradication,     hospitalization length, emergence of resistance to colistin during treatment.   "
130425|NCT01577849|"     The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206 (150mg     Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 ,     qd) after oral administration in healthy adult volunteers.   "
130426|NCT01577836|"     The main objective of the study is to estimate and compare the overall cost of care of     patients over 24 months of follow-up between two groups: (1) patients undergoing     robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing     robot-assisted radical prostatectomy via laparotomy.   "
130427|NCT01577823|"     A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical     patients receiving spinal anesthesia. Study will track clinical outcomes, patient     satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary     tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden     without increasing postoperative urinary retention (POUR) incidence.   "
130428|NCT01577810|"     It is routine practice for a cardiologist to perform a battery of tests to assess the degree     of heart failure. The purpose of this study is to establish a non-invasive method to reliably     predict cardiac output state in real-time in children and adolescents with heart failure in     an outpatient setting. This study will rely on the use of near infrared spectroscopy monitors     to measure cardiac output in the outpatient setting.   "
130430|NCT01577784|"     The principal aim of the study is to determine the objective response rate that offers the     second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that     have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase     Inhibitor. The secondary aims are to determine the overall survival and the treatment safety     profile for these patients in second-line treatment with pazopanib. The exploratory aim is to     determine the correlation between biomarkers in patient blood and tumor samples, and the     clinical results obtained with pazopanib.   "
130433|NCT01577745|"     This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation     (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity     of MEDI0639.   "
130434|NCT01577732|"     This study aims to evaluate the safety and reactogenicity of a booster dose of     Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age     who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within     their first six months of lives.   "
130467|NCT01577290|"     The purpose of this study is to examine the effects of a 10 week mindfulness training program     -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of     life, and insomnia symptoms will also be studied.   "
130567|NCT01575990|"     The purpose of this research study is to explore ways to improve appropriate colorectal     cancer (CRC) screening in the elderly by attempting to target screening in those most likely     to benefit and avoiding screening in those least likely to benefit.   "
130435|NCT01577719|"     People who originate from the Indian subcontinent known as South Asians are the fastest     growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity,     type 2 diabetes and heart disease. They also develop these risk factors at significantly     lower body weight and at younger ages compared to people of European origin. The purpose of     SAHARA (South Asian HeArt Risk Assessment) Pilot, is to recruit 400 South Asians from     Ontario, who use the internet, email and other multimedia devices. Among these participants     the investigators will compare the effectiveness of a 6-month interactive multi-media health     behaviour intervention to usual care in reducing cardiac risk factors. This intervention     enables participants to set their health goals and provides health messaging and feedback     designed to improve their smoking, dietary habits and physical activity. In addition, the     investigators will test if knowledge of genetic risk for heart attack influences behaviour     change and their heart health risk factor profile. The information generated from SAHARA will     enable individuals, physicians, health professionals, and policy makers to develop risk     factor modification programs to prevent cardiovascular disease in this high-risk group.   "
130436|NCT01577706|"     An advanced technique for rapid magnetic resonance proton spectroscopic imaging (1H-MRSI)     will be employed in a drug challenge study in healthy volunteers to spatially map and measure     acute changes in the brain chemicals GABA, glutamate and glutamine after administration of a     drug. Three condition will be tested in a double-blind fashion, i)depressant, ii)stimulant,     iii)placebo. It is hypothesized that unique and reproducible spatial and directional     metabolic response patterns will be observed, unique to each condition within the brain.   "
130437|NCT01577693|"     The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel     formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted     healthy male subjects.   "
130438|NCT01577680|"     This study will assess the safety and pharmacokinetics of GSK573719 and GSK573719/vilanterol     combination in healthy subjects and subjects with moderate hepatic impairment. The results of     this study will provide guidance on the use of the product in patients with hepatic     impairment.   "
130439|NCT01577667|"     Partial automation of mechanical ventilation in resuscitation has been available for several     years. New modalities are being developed to completely automate ventilation and oxygenation     parameters (IntelliVent®.      This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a     conventional ventilation modality.   "
130440|NCT01577654|"     This study will test the activity of single-agent EC145 and the combination of EC145 plus     docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer     (NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants     of the lung) in participants with all target lesions expressing the folate receptor [FR(++)].   "
130441|NCT01577628|"     There is a lack of prospective scientific data on the regular use of moisturizers in patients     at risk of developing atopic dermatitis. Although generally accepted and widely used for     secondary prevention, emollients have not been studied as a primary prevention strategy.     Strategies previously studied for the prevention of atopic dermatitis include maternal and     child's dietary manipulations, allergens avoidance, delay of food introduction, exclusive     breastfeeding and probiotic supplementation. Despite years of research, none of those     strategies yielded to strong evidence of a protective effect. There is therefore a need to     explore novel strategies.      There is a need to compare the cumulative incidence rate of atopic dermatitis in newborns     using a standard bathing and moisturizing routine with a good moisturizer to a non     interventional group.      This 2-year study will recruit approximately four hundred and sixty (460) pregnant women with     a first degree relative of the child to be born who currently has (or previously had) a     diagnosis of atopic dermatitis in order to study approximately 200 eligible newborns in each     of the two study groups at the beginning of the study.      Pregnant women will be randomized (1:1) to either daily use of the moisturizer Lipikar Balm     AP (applied to their infant) starting from birth (Group 1) immediately after bathing or to no     intervention (Group 2).   "
130442|NCT01577615|"     The PEPI study is designed to provide a patterned feeding experience. By using a regularly     occurring and necessary caregiving event, feeding, as the vehicle for the patterned     experience, the intervention should be effective at promoting and reinforcing neuronal growth     and connections that are critical for neurobehavioral and cognitive function while at the     same time being cost effective in its delivery.   "
130443|NCT01577602|"     The purpose of this study is to determine if two basic medical office visit interventions     improve the agreement of medication lists between electronic medical record and patient self,     home-based report. The interventions are:        -  giving patients a printed list of medications before the visit        -  asking the patients about their medications with a scripted, open ended question.   "
130444|NCT01577589|"     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of     Ceftaroline 600 mg when administered by varying infusion volumes.   "
130445|NCT01577576|"     The main objective of this study is to obtain data for the integrated analysis of     morphological, functional and biomechanical parameters pertaining to lower limb arteries in     various categories of elite athletes (without cardiovascular risk and practicing high- or     low-impact aerobic activities which preferentially implicate lower limb activity) as compared     to (each other and to) sedentary controls.   "
130446|NCT01577563|"     RATIONAL is a multinational, multicentre, observational, cross sectional study of adult     patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before     study visit (at least one dose).   "
130447|NCT01577550|"     Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to     severe psoriasis.   "
130448|NCT01577537|"     The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to     placebo gel for the treatment of bacterial vaginosis (BV).      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or     hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime     for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and     Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12)     and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day     21-30).   "
130451|NCT01577498|"     Economic globalisation has been associated with a rise of cross-border migration in Europe.     In France, courts commonly demand appropriate medical tests aimed at age estimations of     supposed minors without documentation. Determining the age of foreign adolescents may be     important in order to define the rights and protection afforded them by law depending on this     status, and the conditions in which they may be detained or held in police custody if they     are under suspicion. Age estimation is considered to be ideally based on the combination of     clinical, skeletal, and dental examinations. A number of forensic physicians do not integrate     published recommendations or the results of published studies into their daily practice.     Previous studies have shown that medical practice is heterogeneous in this area. Factors     determining this heterogeneity are unknown.      We hypothesize that the personal and professional development of the physician, as well as     the characteristics and the circumstances of medical examination can affect medical response     on age determination, beyond clinical and radiological data. The purpose of this study is to     identify factors determining medical response to courts.   "
130452|NCT01577485|"     We want to study the effect of short-term consumption of probiotics (a mixture of L.     rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.   "
130453|NCT01577472|"     The aim of this study is to assess the oocyte yield of infertile women with suspected or     known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional®     starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC     (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT     has been conducted to compare the reproductive outcome of patients with POR as defined by the     ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH     antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We     hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an     additional increment of endogenous GT thus increasing the oocytes yield after controlled     ovarian stimulation due to higher endogenous gonadotropin secretion.   "
130454|NCT01577459|"     This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the     pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult     volunteers.   "
130455|NCT01577446|"     Current recommendations require a QRS duration of ≥120ms as a condition for prescribing     cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that     patients with heart failure of ischemic origin, current indications for defibrillator     implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical     dyssynchrony.   "
130456|NCT01577433|"     The purpose of this observational registry is to determine the freedom from driveline (DL)     infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone     portion of the DL is externalized resulting in a silicone skin interface (SSI)   "
130457|NCT01577420|"     The aim of this study is to test a complementary therapy intervention (reflexology) that will     assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage     (III or IV) breast cancer within the context of conventional medical care. Quality of life     will be assessed via intermediate indicators: 1) physical indicators (greater physical     functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower     anxiety, and lower depressive symptomology); and the outcome indicator of quality of life.   "
130458|NCT01577407|"     The purpose of this protocol is to test the effects of the non opioid nefopam on experimental     dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by     dyspnea in healthy subjects.   "
130521|NCT01576588|"     The study will test the efficacy rituximab in addition to glucocorticoids for the treatment     of B-CLL in elderly or unfit patients.   "
130461|NCT01577368|"     The main objective is to verify that the administration of piperacillin / tazobactam     administered by continuous infusion to treat complicated infections or with known or     suspected nosocomial isolation of Pseudomonas aeruginosa is superior in efficacy to a 30%     higher dose administered in conventional short infusion.      The secondary objectives were compared between the following variables:        -  Microbiological response at 3 days of starting treatment        -  Time to microbiological cure        -  Clinical response at 3 days of starting treatment        -  Time to achieve defervescence        -  To examine the relationship between pharmacokinetic variables and parameters of efficacy          and safety        -  To test the hypothesis that continuous infusion maintains adequate plasma drug levels          compared with levels achieved with intermittent administration.        -  Cost-effectiveness analysis        -  Occurrence of adverse effects      To this end, we designed a multicenter, randomized, controlled, double blind, comparing both     forms of administration in patients with complicated or nosocomial infection with or without     isolation of Pseudomonas aeruginosa.      Patients who are candidates for inclusion are classified according to APACHE II and to have     or not isolation of Pseudomonas aeruginosa. Subsequently be randomized to receive     piperacillin-tazobactam by continuous infusion or short. Primary endpoint was measured as the     ultimate effectiveness of treatment and other variables such as high efficiency, safety,     pharmacokinetic and pharmacoeconomic.   "
130462|NCT01577355|"     This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the     absorption, distribution, metabolism and excretion of LY2784544. This study is for research     purposes only and is not intended to treat any medical condition.   "
130463|NCT01577342|"     Ranibizumab (Lucentis) is currently the best treatment for wet Age-Related Macular     Degeneration (AMD). To work, the drug must be injected by means of an intravitreal injection     (IVT) into the vitreous (jelly-like material) cavity in the back of the eye, repeatedly at     intervals ranging from one to several months. Endophthalmitis is a rare but devastating     infection of the eye that occurs in approximately 0.2% of patients after IVT injection. Many     ophthalmologists ask patients to use antibiotic eye drops after IVT injection in the hope     that this may reduce the risk of endophthalmitis. There is no proof that this happens and     there is a possible risk that repeated exposure to the same antibiotic may cause antibiotic     resistance organisms (bacteria) to develop over time.      The investigators hypothesize that repeated exposure to antibiotic during the initial stages     of treatment for AMD will result in a progressive shift in the conjunctival flora with an     increasing number of antibiotic resistant organisms appearing over time. If this is     demonstrated, changes to the prevailing treatment approach will be needed to reduce the long     term risk of a patient developing antibiotic resistant endophthalmitis during treatment.   "
130468|NCT01577277|"     The present study is based on cross-sectional data from the baseline investigations carried     out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools     in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12     year olds) took part in these baseline investigations of socioeconomic status, pubertal     status, growth status, learning abilities, well-being, sleep, physical activity and risk     markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.   "
130469|NCT01577264|"     This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated     with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.   "
130470|NCT01577251|"     The goal of this study is two-fold: to establish a tissue banking respository (defined as     blood, urine, soft tissue, tumor specimen, and normal tissue from areas surrounding tumor     specimens), and to prospectively assess health related quality of life (QOL) over time in     patients with a pathologically confirmed diagnosis of neoplasia receiving radiotherapy or     photodynamic therapy (PDT)   "
130471|NCT01577238|"     The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to     placebo gel for the treatment of bacterial vaginosis (BV).      After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or     hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime     for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and     Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12)     and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day     21-30).   "
130472|NCT01577225|"     OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer,     lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is     coated with a water-based adhesive. The comparator is a standard care treatment regime     comprising tape and gauze.      This study requires 100 eligible patients which will be recruited from the patients routinely     see by the study investigators at each study site. Eligible patients will undergo surgery     that results in a surgical wound of 27cm or less that is expected to have low or moderate     levels of exudate and will have received at least one randomised study treatment. The primary     objective is to compare OPOV and tape/gauze in terms of wear time per patient.   "
130473|NCT01577212|"     The aim of this present study is to test the feasibility and toxicity of individualized     hypofractionated radiotherapy, and to report outcome data. In case this phase II trial has     favorable results, a phase II/III trial on maximally tolerable, individualized,     hypofractionated radiotherapy within a shorter overall-treatment time is aimed for.   "
130474|NCT01577199|"     The purpose of this study is compare two commonly-used medication protocols ( low-dose     clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with     diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF.     This research is being done because we do not know if these two medication protocols are     equally likely to help a woman become pregnant.   "
130475|NCT01577186|"     The purpose of this study is to explore the relationship between achieving symptomatic     remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and     personal and social functioning by means of the Personal and Social Performance (PSP) scale     in participants treated with flexibly dosed paliperidone ER.   "
130476|NCT01577173|"     This phase II, open-label, randomized study will evaluate the efficacy and safety of     MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of     the head and neck who have progressed during or following platinum-based chemotherapy.     Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2     weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients     treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation     of progressive disease and upon meeting eligibility criteria. Anticipated time on study     treatment is until disease progression or intolerable toxicity occurs.   "
130477|NCT01577160|"     The purpose of this study is to evaluate the effectiveness of paliperidone ER for the     treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability,     detachment from reality, often with delusions and hallucinations, and withdrawal into the     self) participants.   "
130478|NCT01577147|"     Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation     prediction products to help identify their most fertile time and aid conception. Volunteers     will provide SPD with a daily urine sample throughout the study period, which will be used     for the development and validation of SPD products related to pregnancy and fertility.   "
130479|NCT01577134|"     PREFER II aims at developing psychological targeted theory- and evidence-based intervention     components, which support older people with multiple illnesses in performing more physical     activity. Many studies provide evidence for the importance of physical activity as a central     mediator of health. This means that determinants of physical activity such as personal     resources constitute an ideal target for interventions.      Within PREFER II, particularly positive views on ageing, attitudes, self-efficacy, planning     and self-monitoring will be targeted in the interventions. These factors are important both     for motivating older people with multiple illnesses to change their health behaviors and to     translate such motivation into behavior.   "
130480|NCT01577121|"     To demonstrate if indomethacin associated to conventional treatment for preterm labor is     useful to delay delivery and to improve neonatal morbimortality in women with preterm labor     with high risk of intraamniotic inflammation   "
130502|NCT01576835|"     This study will compare the results of a clinically ordered abdominal CT angiography to a     research non-contrast MR angiogram (MRA). CTA is a gold-standard for identifying blockages     in the kidney arteries or other blood vessel problems. CTA requires radiation and contrast to     obtain useful images. Conversely, the MR abdomen technique being used for the study uses no     radiation or contrast and is felt to be a safer option for individuals who have kidney     problems. there is benefit to establishing non-contrast MRA as a clinically accurate test.   "
130568|NCT01575977|"     The main objective of this study is to predict cartilage contact pressures in the hip after     periacetabular osteotomy (PAO).   "
130569|NCT01575964|"     The purpose of this study is to determine the influence of FAI abnormalities on hip joint     biomechanics.   "
130481|NCT01577108|"     The purpose of this study is to examine whether daily use of oral gelatin capsules containing     dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS     colonization rate of vagina and rectum in pregnant women who present with GBS-positive     diagnosed by GBS culture at 35-37 weeks gestation.      This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS     screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our     out-patient department. Subjects with vagina and rectum GBS colonization are invited to     participate in our study after informed consent. A total of 200 pregnant women will     participate in the study during the 12-months trial period. They are randomly assigned to one     of the two groups. The study group is treated with two oral capsules of probiotics once daily     (before sleeping) for 14 days, and the control group will take 2 capsules of placebos.     Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All     participators will treated according to GBS guideline by CDC in 2002 during laboring.   "
130482|NCT01577095|"     Aims: To evaluate the efficacy of rosiglitazone (TZD) and electroacupuncture (EA) combined     therapy on patients with type 2 diabetes mellitus (T2DM). A randomized single-blind placebo     controlled clinical trial was used.      Methods: A total of 31 newly diagnostic type 2 diabetic patients, who fulfilled the     eligibility criteria were recruited and received various allocated interventions. They were     randomly assigned into two groups, the control group (TZD, N=15) and the experimental group     (TZD + EA, N=16). Changes in their plasma free fatty acid (FFA), glucose and insulin levels     together with their homeostasis model assessment (HOMA) indices were statistically assessed     between before and after treatment. Hypoglycemic activity (%) was also compared between these     two groups.      Expecting Results: This study will compare the hypoglycemic activity and the ability of     improving insulin resistance between the TZD and TZD+EA group. Also, the lowering effect of     the plasma FFA concentration will be investigated.   "
130483|NCT01577082|"     The purpose of this study is to show the superiority of CHF 1535 (BDP/FF) pMDI over BDP HFA     pMDI in terms of lung function considering change from baseline to the entire treatment     period in average pre-dose morning PEF in adult asthmatic patients not adequately controlled     on high doses of ICS or on medium dose of ICS+LABA.   "
130484|NCT01577069|"     The purpose of the study is to      1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS)     technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients     under/after Telaprevir treatment.   "
130485|NCT01577056|"     The purpose of this study is to determine whether fish oil supplementation is effective in     the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.   "
130486|NCT01577043|"     The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea     in children. The investigators will evaluate the effect of product versus placebo.   "
130522|NCT01576575|"     The purpose of this study is to determine how people absorb and break down (metabolize) and     eliminate buprenorphine and if CYP3A is involved.   "
130523|NCT01576562|"     The purpose of this research study is to test the function of a subjects implantable     cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD     function can be altered during some types of heart surgery such as those when a pump     (ventricular assist device - VAD) is implanted. The investigators would like to study the     mechanism of device and ICD malfunction.   "
130487|NCT01577030|"     Elevated systolic blood pressure is by far the largest single contributor to cardiovascular     risks in middle-aged and older adults. Lifestyle modifications, including dietary     modifications, are the first line approach for treating and preventing hypertension. The     general aim of the proposed study is to address the efficacy of conventional dairy products     as part of the normal routine diet for lowing arterial blood pressure in middle-aged and     older adults with elevated blood pressure. The investigators hypothesize that the dietary     intervention including dairy products will induce significant decreases in arterial blood     pressure in this population. A secondary aim will be to test the hypothesis that these     reductions in systolic blood pressure will be associated with increases in arterial     stiffness/compliance and endothelial vasodilatory function.   "
130488|NCT01577017|"     As both medications i.e. CC and letrozole have been shown to be effective in inducing     ovulation in PCOS patients, this study was performed in order to evaluate which regime     (whether CC or letrozole) is the best to be used as the first line treatment for PCOS     patients with infertility for local population. The best regime will therefore could be     included in the protocol of management of infertility patients with PCOS so that the quality     of patients' care could be improved.   "
130489|NCT01577004|"     BACKGROUND: Compared to the epsilon 2 or epsilon 3 alleles, the epsilon 4 allele of     apolipoprotein E (ApoE4) is associated with twice the prevalence of late-onset Alzheimer's     disease (AD). Epidemiological studies show that risk of AD varies inversely with consumption     of omega-3 fatty acids from fish and seafood. Despite apparently lower fish intake in AD,     pooled analysis of the literature shows that plasma and brain docosahexaenoic acid (DHA) is     actually the same in AD as in healthy age-matched controls. Fish oil trials in AD are also     not convincing. We recently shown that ApoE4 carriers have 41% higher fasting plasma EPA and     DHA compared to non-carriers, but the plasma EPA and DHA response to fish oil in ApoE4     carriers was half that seen in non-carriers.      HYPOTHESES: (i) Carriers of ApoE4 have altered metabolism of carbon-13 (13C)-DHA as well as     EPA and DHA provided in a dietary supplement. (ii) A dietary supplement of EPA+DHA will     improve cognitive performance but only in non-carriers of ApoE4.      OBJECTIVES: In both carriers and non-carriers of ApoE4, to compare whether- i) ApoE4 alters     incorporation of 13C-DHA into plasma lipids or its beta-oxidation.      ii) 13C-DHA metabolism changes while on a dietary supplement of EPA+DHA; iii) Better     cognitive performance occurs while on EPA+DHA and is linked to raising plasma EPA and/or DHA.      EXPERIMENTAL METHODS: Participants older than 50 y old and not demented were enrolled. DHA     metabolism was evaluated using both 13C-DHA and an EPA+DHA supplement (2.4 g/d for 5 mo; n =     20/gp). Before and in the last month of supplementation, plasma uptake and beta-oxidation of     50 mg of 13C-DHA was followed during one month. Blood omega-3 fatty acids was evaluated     monthly during the supplementation period. Cognitive testing was performed before and 4     months after starting the omega-3 fatty acid supplement.      IMPLICATIONS: This project will help explain the apparent link that is newly emerging between     ApoE polymorphisms, altered omega-3 fatty acid metabolism and risk of cognitive decline, and     should help in the development of nutraceutical-based clinical trials using fish oil for the     elderly.   "
130490|NCT01576991|"     The purpose of the study is to describe the relationship between leukocyte, granulose cell     and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of     oocyte spindles and their frequency in the eggs from older women and associations with     aneuploidy.   "
130693|NCT01574547|"     This study was designed to: estimate the incidence of cat scratch colon in the investigators     environment; explore the diseases associated to its development; identify the factors related     to its development; and assess its clinical repercussions.   "
130491|NCT01576978|"     The aim of this study is to identify evaluate the effectiveness of stretching exercises of     Hatha Yoga method in pregnant women with back pain and posterior pelvic City Paulínia. -There     will be a randomized clinical trial with 60 pregnant women with these symptoms. They will be     randomly divided into 2 groups. The group A will perform the exercises of Hatha Yoga for ten     weeks, once a week group B postural follow the guidelines recommended for the treatment of     these pains, for ten weeks. Will be used as a technique for evaluating the Visual Analogue     Scale to measure pain intensity and confirmation tests of the lumbar and posterior pelvic     pain in order to differentiate them. A descriptive statistical analysis of univariate and     bivariate distributions will be made through frequency and graphical representation. The     association between the variables will be tested by statistical tests: [chi-square (X ²)],     Fisher's exact test, Student's t test or Mann-Whitney, [Student's t test to compare means],     ANOVA for the analysis of effects between the groups. [The significance level is     predetermined to 5%]. The data will be analyzed in EPI-INFO 2000. SAS 9.0 and from the     database created .   "
130492|NCT01576965|"     The purpose of this study is to learn about bowel preparation (cleansing) before laparoscopic     hysterectomy and/or sacrocolpopexy. We are most interested in the ability of the surgeon to     view necessary anatomy for the surgery, which will be assessed by a questionnaire completed     at the end of your operation by the surgeon. We hypothesize that bowel preparation before     laparoscopic hysterectomy will result in improved ability of the surgeon to view necessary     anatomy for the surgery.   "
130493|NCT01576952|"     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of     topical administration of ISV-303 compared with DuraSite Vehicle.   "
130494|NCT01576939|"     The main objective of this study is to determine the feasibility of optimizing the IMRT     treatment plan based on dosimeter measurements of mucosal radiation dose adjacent to the     dental fillings to reduce such dose to < 35 Gy without compromising tumor coverage and/or     increasing the dose to the remaining oral cavity or nearby parotid glands.   "
130495|NCT01576926|"     Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation     stylopharyngeal muscle.   "
130496|NCT01576913|"     Study hypothesis: Music pacing improves the quality of exercise testing in children.      Children tend to cycle in a non-constant pace during exercise testing, which might make the     test less reliable.      20 boys will perform two exercise tests on a cycle ergometer. One test will be done with     constant tempoed music, and the other without. Different parameters will be checked including     pedaling cadence, aerobic fitness, level of work load obtained.   "
130497|NCT01576900|"     In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better     outcomes.      Systemic video instruction might prove to be beneficial by helping patients have better     understanding on treatment and replacing healthcare personnel.   "
130498|NCT01576887|"     This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl     treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM)     on peritoneal dialysis.   "
130524|NCT01576549|"     This study will investigate how LY2127399 works in participants with rheumatoid arthritis     (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399     via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study     procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA     activity.   "
130525|NCT01576536|"     The aim of the study is to test whether genetic variation in the alpha 2A adrenergic receptor     affects diurnal variation in platelet aggregation.   "
130499|NCT01576874|"     The purpose of this study is to determine the impact of gender and hormones (estradiol,     progesterone, testosterone and cortisol) on responses to stress and smoking cues presented in     daily, real-world cue presentations compared to a final cue session in a lab. In addition,     the study will examine the impact of a single dose of oxytocin (chemical produced in the     body) versus placebo (inactive substance) on stress in males and females.      This study involves a cue presentation technology known as CREMA (Cue Reactivity Ecologic     Momentary Assessment) which delivers four daily cue presentations to you on a handheld device     during your everyday routine. Additionally, the study involves daily collection of saliva     samples for hormonal testing. These daily procedures will provide information about the role     of cues and hormones in daily life.   "
130500|NCT01576861|"     After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients     With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the     investigators wanted to collect data about the long-term efficacy and safety of this kind of     therapy.   "
130501|NCT01576848|"     Rationale: Age related muscle loss (sarcopenia) is assumed to be related to the impaired     postprandial muscle protein synthetic response to protein and/or amino acid administration in     the elderly vs the young. Co-ingestion of carbohydrate increases post-prandial insulin     secretion. Insulin affects skeletal muscle blood flow and may therefore affect substrate     availability and postprandial muscle protein synthesis. However, it is unclear whether the     response to the combined intake of protein and carbohydrates is different in elderly compared     to young subjects.      Hypothesis: Adding carbohydrate to a bolus of protein represents an effective strategy to     overcome the impaired postprandial muscle protein synthesis in the elderly.      Objective: The primary objective of the study is to investigate whether carbohydrate     co-ingestion augments the in vivo postprandial muscle protein synthetic response after     protein ingestion and whether this response is different between young and elderly subjects.     The secondary objective of the study is to assess the effect of carbohydrate co-ingestion on     insulin levels and microvascular perfusion in young and elderly subjects.      Intervention: The intervention consists of a single test day during which the subjects will     receive a drink containing 20 gram intrinsically labelled casein with or without 60 gram     carbohydrates. In addition, continuous intravenous tracer infusions of labeled amino acids     will be administered. During the test day 18 plasma samples and 4 muscle biopsies will be     collected over a period of 8½ h. Furthermore, muscle skeletal blood flow will be estimated     using sidestream darkfield imaging (SDF) in sublingual position.   "
130570|NCT01575951|"     This is a pilot study to determine the diagnostic value of dynamic contrast enhancing MRI     (DCE-MRI) in soft tissue sarcoma for assessment of tumor radiographic changes in vascular     permeability and microvessel density before and after preoperative radiotherapy.   "
130503|NCT01576822|"     The goal of this study is to assess the feasibility of the approach, conduct a dose-finding     investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials     in the assessment of human chemical body burden reduction, for general wellness,     detoxification, and pain reduction.      The investigators wish to determine if a hyperthermia-based detoxification protocol is     feasible to conduct: including assessment of recruitment, enrollment, retention, protocol     adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).   "
130504|NCT01576809|"     This is an open label, in-use study to assess the warming sensation, acceptability and local     tolerability of paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg syrup, given as     a single dose in subjects suffering from symptoms of an upper respiratory tract infection.     The purpose is to evaluate the acceptability concerning a warming sensation effect and its     potential benefit in the target population.      The primary objective is to assess the warming sensation caused by the excipient IFF flavor     316 282, in a syrup containing paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg     per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.      The Secondary Objectives are to assess subject acceptability of the syrup and the safety and     tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from     symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal     congestion associated with colds and flu symptoms such as pain, headache and/or fever.     Subjects must have one or more symptoms per category:        1. mild to moderate body pain, headache, fever or sore throat        2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing        3. productive cough Adolescents will be included in the study population   "
130505|NCT01576796|"     This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in     the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC     not amenable to surgery and candidate for chemoradiotherapy.      Preliminary studies in head and neck cancers have demonstrated the feasibility and support     the medical benefit of this novel approach.      The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement     (boost) in this difficult medical condition for which only limited treatment options are     available.   "
130506|NCT01576783|"     The purpose of this study is to examine whether supplementation with certain polyunsaturated     fatty acids can help the cognitive development of children born preterm.   "
130507|NCT01576770|"     The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch),     used to numb the skin before IV placement, is effective in reducing pain associated with     propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl     Chloride topical anesthetic skin refrigerant.   "
130508|NCT01576757|"     The purpose of this study is to determine whether the harvest, isolation and culture of     cardiac stem cells from endomyocardial biopsies is feasible.   "
130526|NCT01576523|"     The aim of the study is to assess what happens to C1-esterase inhibitor that is administered     under the skin of subjects with hereditary angioedema. Three different dosing regimens of     C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3     dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in     the blood will be measured during each 4-week period. The study will also examine how well     C1-esterase inhibitor administered under the skin is tolerated by the subjects.   "
130509|NCT01576744|"     Human epididymal secretory protein 4 (HE4) is a new biomarker for ovarian cancer. The effect     of IVF stimulation will be evaluated in order to see whether severe hormonal changes in the     gonadotrophin and steroid status affect the serum levels of this marker. Findings will be     compared to serum concentrations of CA-125, which is currently the most often used marker for     ovarian cancer.      The intention is to determine the serum concentration of HE4 and CA-125 in serial samples in     20 women undergoing IVF stimulation. Samples will be taken following GnRH agonist     suppression, 2-3 times during FSH stimulation, at ovum pick up and two weeks following embryo     transfer at the time of the hCG-test. The ovarian follicle count and the serum estradiol     concentrations are recorded throughout the treatment. The serum biomarker HE4 is expected to     ba a stable marker, which does not respond significantly to hormonal stimulation.   "
130510|NCT01576731|"     As a measure of secondary prophylaxis, and with the final objective of avoiding the     infection, it has been suggested to use antiretroviral therapy. This is known as     post-exposure prophylaxis (PEP).      Although there are different recommendations, almost every guideline recommend using 3 drugs     as PEP both in USA and Europe.      Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are     attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.      A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus     the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a     high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.   "
130511|NCT01576718|"     The primary objective of this study is to evaluate the dose response, efficacy and safety of     4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as     Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in     subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high     dose ICS therapy.   "
130512|NCT01576705|"     Evaluation of the following in very young children with Down syndrome:        -  the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically          and by ultrasensitive thyreostimulating hormone (TSH) assay),        -  the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,        -  any interaction between these two treatments.   "
130513|NCT01576692|"     This is a safety / feasibility trial evaluating the combination of a humanized anti-GD2     antibody (HU14.18K322A) manufactured at the Children's GMP, LLC at St. Jude with allogeneic     natural killer (NK) cells and standard chemotherapy in children with relapsed or refractory     neuroblastoma.   "
130514|NCT01576679|"     The objective of this study is to establish the efficacy of tPA when used in pediatric     intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the     ultrasound appearance or consistency of the drained fluid.   "
130571|NCT01575938|"     The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction     intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or     transmission.   "
130515|NCT01576666|"     The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be     safely given together to patients and/or the dose that will be used in future studies. This     study will also learn more about how the combination of these two investigational drugs may     work for patients with certain cancers (specifically metastatic breast cancer, advanced     pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma     multiforme).   "
130516|NCT01576653|"     In patients with invasive fungal infection (IFI) rapid diagnosis is essential for early     initiation of appropriate antifungal therapy and thereby survival. Conventional culture is     still the Gold-Standard for diagnosis of IFI. Sensitivity of conventional culture, however,     is low (50%) and time to results minimum 24 hours.      Therefore usage of serological tests detecting fungal antigens has increased dramatically     over recent years. Main advantages of this new methods are rapid results and higher     sensitivity when compared to conventional culture. One of the most promising serological     marker currently used is beta-D-Glucan, which is a component of the fungal cell wall.     ß-D-Glucan has been detected in IFI caused by Aspergillus, Candida and Fusarium spp. The     Fungitell Assay (Associates of Cape Code, Inc.) was developed and validated for detection of     ß-D-Glucan in peripheral blood.      Up to date information about clinical performance of the Fungitell Assays in bronchoalveolar     lavage fluid (BAL) is limited. This study will therefore evaluate clinical and diagnostic     performance of the Fungitell Assay in BAL from patients with solid organ transplant or     hematologic malignancy.      In addition Mn/A-Mn, the lateral flow device test for aspergillosis, and Galactomannan, as     well as PCR will be determined and used as comparators for BDG performance.   "
130517|NCT01576640|"     After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse     shortly after discontinuation of treatment. The purpose of this study was to assess the     feasibility and effectiveness of a 12-month relapse prevention intervention in recently     abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation     phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and     cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1     week of abstinence, they continued in the relapse prevention phase of the study, where they     continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive     behavioral therapy.   "
130518|NCT01576627|"     The goal of this trial is to evaluate zinc citrate, a zinc compound with promising sensory     properties and a high zinc content, as an alternative zinc compound to be used for     supplementation or food fortification. The bioavailability of zinc citrate given as a     supplement to young Swiss adults will be assessed and compared to the bioavailability of the     commonly used zinc compounds zinc gluconate and zinc oxide.   "
130519|NCT01576614|"     Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the     surgical intensive care unit has an impact on nurse-physician collaboration.      Study question: Does the addition of mobile video communication provided by RTP affect     nurse-physician collaboration during off shift rounding in the surgical intensive care unit     when compared to the more common clinical practice of off-shift rounding using the telephone?   "
130520|NCT01576601|"     The purpose of this prospective, clinical observational trial is to assess the incidence of     pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics,     methods of analgesic delivery, and patient/parent satisfaction in patients undergoing     craniotomy surgery at three major children's hospitals (Boston Children's Hospital,     Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the     United States.   "
130527|NCT01576510|"     To employ a fear learning-extinction paradigm with functional magnetic resonance imaging     (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic     stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural     circuits underlying PTSD and b) to probe brain based predictors of symptomatic improvement in     response to Prolonged Exposure (PE) treatment, and first line treatment for PTSD.   "
130528|NCT01576497|"     EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's     preference, EUS-FNA with suction or without suction technique has been used. To date, little     is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15     to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of     to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the     contamination of blood in specimen and possible adverse event may occur. To determine optimal     number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction     or without suction, this prospective single-blinded randomized trial was conducted.   "
130529|NCT01576484|"     This is a phase 2, open-label extension study to assess the long-term safety and efficacy of     REGN727 (SAR236553) administered by subcutaneous (SC) injection in patients previously     participating in the R727-CL-1003 study.   "
130530|NCT01576471|"     This is a randomized, double-blind, placebo-controlled, multicenter, and proof of concept     study with a parallel group design to evaluate the safety and efficacy of oral Trichuris Suis     Ova (TSO) suspension, as compared to placebo, in patients with moderately to severely active     Crohn's disease. This study will also have an optional open-label extension for patients     completing the double-blind phase of the study.   "
130531|NCT01576458|"     The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid     (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).      In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP     received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the     third trimester of pregnancy. The severity of pruritus was registered. Itching scores and     serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone,     prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time     (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and     weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.   "
130572|NCT01575925|"     The purpose of this study is to determine the pharmacokinetics (PK) and safety for the     combination of pomalidomide (POM) + low-dose dexamethasone (LD-DEX) in subjects with relapsed     or refractory Multiple Myeloma (RRMM) and impaired renal function.   "
132871|NCT01545765|"     The purpose of this study is to evaluate the duration of anesthetic effect produced ,     Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face     and thigh.   "
130532|NCT01576445|"     When performing total knee replacement surgery, the surgeon has a choice as to which type of     surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the     so-called 'medial parapatellar' exposure. And alternative and more recently introduced     technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the     muscle at the front of the leg. In this study we compare the two surgical techniques in a     so-called randomized trial. This means that we put people randomly into two groups, one group     will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the     'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus     approach recover quicker and have a better short-term functional outcome than people who     receive the 'Medial parapatellar approach'.   "
130533|NCT01576432|"     Objective      To investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to     skin-to-skin contact versus other methods of non-pharmacological analgesia during blood     sampling through heel lance in healthy term neonates. The influences of non-pharmacological     methods on crying time, percentage of crying while sampling, heart rate, number of attempts     and duration of sampling were studied.      Methods      Randomised controlled trial performed on 136 healthy term newborns in the maternity ward of a     tertiary hospital. The inclusion criteria were: healthy term neonates, wish to breastfeed and     absence of feeding during the previous 60 minutes. Neonates were randomly assigned to four     groups: group 1, breastfed with skin-to-skin contact ; group 2, oral sucrose with     skin-to-skin contact ; group 3, skin-to-skin contact ; or group 4, receiving oral sucrose     Data for the primary objective was analysed per intention to treat. This study was approved     by local ethical committee.   "
130534|NCT01576419|"     The objective of this study was to to evaluate the efficacy and safety of PG201 in     osteoarthritis patients.      This clinical study was designated to be non-inferiority test with level of significance:     95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%.     Assuming 20% drop-out rate, the number of subjects required for each treatment group was     estimated to be 154, while the total number of subjects required for the study 308.      non-inferiority margin: 8mm   "
130535|NCT01576406|"     This study is designed to evaluate the potential effect of hepatic impairment on the     pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer     patients with mild, moderate or severe liver dysfunction as well as patients with normal     liver function will be enrolled in this study.   "
130536|NCT01576393|"     Given the reciprocal nature of parent-child interaction, involvement of the adolescent in     their mother's substance abuse treatment plan might be associated with reductions in adult     relapse and improvements in child functioning. These findings would support the assertion     that focus on family dynamics in substance abuse treatment programs is an effective use of     resources and an important target of intervention efforts. One hundred eighty-three substance     abusing mothers and their child (n=61 assigned to each condition) will receive treatment as     usual (TAU) and be randomly assigned to 1) Ecologically-based family therapy (EBFT) conducted     in the home or 2) Ecologically-based family therapy conducted at the treatment center, or 3)     an attention control, Women's Health Education (WHE). In order to examine the endurance of     treatment effects, this project will assess the parent and child at 3, 6, 12, and 18 months     post-baseline.      Hypotheses        1. It is expected that 1) mothers and children assigned to home and office based family          therapy will show greater reductions in substance use and improvement in individual and          family functioning at post-treatment compared to those in the attention control, and 2)          those assigned to home-based family therapy will show greater reductions in substance          use and improved individual and family functioning at post-treatment compared to those          assigned to office-based family therapy.        2. It is expected that 1) those assigned to home or office based family therapy will          continue to maintain improvements in substance use, individual and family domains over          time (time by treatment interaction) compared to those assigned to the attention control          and 2) those assigned to home-based family therapy will continue to maintain          improvements in substance use, individual and family domains over time (time by          treatment interaction) compared to those assigned to office-based family therapy.        3. It is hypothesized that improved family interaction skills will mediate substance use,          individual and family outcomes.        4. It is expected that EBFT in the home and EBFT in the office will be more cost effective          than TAU, and that EBFT in the home will be more cost effective than EBFT in the office   "
130537|NCT01576380|"     This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof     of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate     efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma     (SGC) that have progressed after one or two prior systemic treatments.   "
130538|NCT01576367|"     This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS     patients that completed the CACZ885D2307 study   "
130539|NCT01576354|"     The objective of the present investigator-initiated mono-center trial to be performed at the     Department of Neurology of the University Hospital Zurich is a detailed characterization of     the effects of prolonged-release fampridine on walking function of 50-70 patients with MS. In     a randomized, double-blind, placebo-controlled study with cross-over design, changes of     essential gait elements such as stability, coordination, correct loading, posture or     endurance in addition to walking speed after treatment with prolonged-release fampridine will     be investigated using a comprehensive kinematic gait analysis protocol. This protocol     comprises outcome parameters ranging from very specific and sensitive biomechanical measures     to clinically meaningful indicators of improved ambulatory function. Kinematic, kinetic and     electromyographic gait parameters will be assessed during treadmill walking (primary outcome     parameters). Changes in overground walking capacity will be investigated by means of     different functional walking tests (e.g. six minute walk test). Furthermore, the patient's     perception of the effects of the treatment on walking function will be evaluated by a     standardized questionnaire. Changes of global ambulatory activity will be assessed     (Actimeter) indicating a successful translation of improved gait (sub-)functions due to     prolonged-release fampridine treatment into everyday life. The study will last for a period     of 18 weeks, excluding the screening period. Based on the mechanism of action, the     investigators hypothesize that treatment with prolonged-release fampridine will not only     improve walking speed, but also clinically more meaningful features of walking function in     patients with MS.        -  Trial with medicinal product   "
130540|NCT01576341|"     The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa     administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney     disease (CKD)   "
130541|NCT01576328|"     This study is being conducted to assess the overall safety and tolerability of a single     intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects     with Type 2 Diabetes inadequately controlled on Metformin.   "
130583|NCT01575782|"     Chloroquine can make tumor cells less resistant to chemo/radiotherapy. In this trial     chloroquine is given during radiotherapy. The dose is increased in cohorts of at least 3     patients.   "
130584|NCT01575769|"     This long-term, interventional, open-label extension study will evaluate the safety and     efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with     polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients     will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment     is 104 weeks.   "
130542|NCT01576315|"     Aspergillus infection is an infectious complication which frequently occurs in cystic     fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent     positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole     and voriconazole in this indication has never been evaluated in a large prospective     controlled clinical trial, even though many teams already use it. The ATCF study aims to     assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the     efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for     Aspergillus.   "
130543|NCT01576302|"     Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent     regurgitation of recently ingested food. Very little is understood about the nature and     treatment of this disorder. The act of regurgitation in rumination involves the opening of     the upper esophageal sphincter and the muscular contraction of the abdomins rectus.     Behavioral treatment of these symptoms is the clinical intervention of choice; however, only     uncontrolled case documentation exists to support its effectiveness. However, an effective     behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular     relaxation is incompatible with the necessary muscular contraction for rumination.      To date, single case documentation and few designed single case studies have examined the     clinical effectiveness of behavioral interventions for GI rumination. In the current study,     the investigators seek to examine the effectiveness of two behavioral relaxation     interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our     primary goals are to examine the clinical effectiveness of these interventions in symptom     reduction at 1- and 3-month follow-up.   "
130544|NCT01576289|"     Multicenter study to correlate histological findings in the upper gastrointestinal tract with     endoscopic and clinical data.   "
130545|NCT01576276|"     Healthy right-handed volunteers aged 21 to 50 needed for a research study of the effects of     morphine and ketorolac on brain activity in response to pain stimuli as measured by     functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). Study     will be conducted on six separate days not requiring an overnight stay in the hospital.   "
130546|NCT01576263|"     Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications     even in elderly patients with previous or current medical conditions. Especially comorbidity     like cardiovascular diseases and conditions with increased risk of bleeding or previous     thrombo-embolic events are major challenges.      To facilitate safe use of ropivacaine as an analgesic, information on the concentrations     levels after autologous blood transfusion following local infiltration analgesia is very     crucial. However, very limited data are available. To verify the safety of autologous blood     transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total     knee arthroplasty or total hip arthroplasty.   "
130547|NCT01576250|"     The purpose of this study is to investigate the effects of lowered physical activity     (resulting in decreased muscle mitochondrial oxidative capacity) alone and together with     increased plasma free fatty acid availability (by infusion of a clinically widely used lipid     emulsion (Intralipid)) on insulin sensitivity and glucose and lipid metabolism. To this end,     we will compare skeletal muscle insulin sensitivity and glucose and lipid metabolism (within     one subject) after 9 days of immobilization of one leg (unilateral lower limb     suspension(ULLS))(decreased muscle mitochondrial oxidative capacity) versus an active control     leg (unchanged muscle mitochondrial oxidative capacity). Further, changes in IMCL and fatty     acid intermediates will be investigated in the immobilized vs the control leg, and this will     be related to insulin sensitivity. The effectiveness of the ULLS intervention will be tested     by measuring muscle mitochondrial oxidative capacity in both the immobilized and the control     leg. All measurements will be performed both in the immobilized and control leg after 9 days     of ULLS.   "
130548|NCT01576237|"     During a five years period the participating transfusion medicine establishments will report     all their non-trivial adverse events (AE) occurring during preparative hemaphereses.     Complications may be related to the blood donors, the blood products, the disposables or the     apheresis devices. The study hypothesis regarding each participating center is that their     procedure-related AE rate is not higher than the respective rate of all other centers in     total.   "
131555|NCT01563055|"     This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic     profile of ofatumumab in combination with chlorambucil in Japanese patients with previously     untreated Chronic Lymphocytic Leukemia (CLL).   "
130549|NCT01576224|"     The aim of this study is to investigate the post operational mobilization after volar locking     plate osteosynthesis of distal radius fractures. One group is admitted training exercises     just after the fracture treatment, one group after 14 days immobilization in a cast.      The primary hypothesis is, that immediate training leads to earlier and faster recovery.      Our second hypothesis is, that immediate training does not lead to increased risk of fracture     displacement.   "
130550|NCT01576211|"     RATIONALE: Studying samples of blood and tissue from newborns and from patients with cancer     in the laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research trial studies cord blood and placenta tissue from newborns, and tumor     tissue samples from patients with Wilms tumor.   "
130551|NCT01576198|"     RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the     laboratory may help doctors to learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms     tumor.   "
130552|NCT01576185|"     These laboratory trial studies the development and treatment of a mouse model for acute     myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples     from patients with cancer in the laboratory may help doctors learn more about cancer and how     well patients will respond to treatment.   "
130566|NCT01576003|"     The purpose of this research study is to evaluate the effects (good and bad) of     supplementation with Glutamine to that of a placebo (L-alanine), on your child and their     Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to     oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections,     improving growth, and/or changing the make-up of bacteria in your child's intestine.     Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study,     the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in     children.   "
130553|NCT01576172|"     This randomized phase II trial studies abiraterone acetate and prednisone together with     veliparib to see how well it works compared to abiraterone acetate and prednisone alone in     treating patients with castration-resistant prostate cancer that has spread from the primary     site to other places in the body. Androgens can cause the growth of prostate cancer cells.     Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by     the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Giving abiraterone acetate together with prednisone and veliparib may work     better than abiraterone acetate and prednisone alone in treating patients with     castration-resistant prostate cancer.   "
130554|NCT01576159|"     Acute effects of physical exercise on the deformational behavior of articular cartilage and     changes in cartilage oligomeric matrix protein (COMP) are definite. However, conclusive     positive effects of fitness exercise on functional adaptation of articular cartilage have not     been proved.Therefore, in this parallel-group randomized control trial, the investigators     tested the hypothesis that adequate amount of physical exercise with enough impact would be     able to stimulate the functional behavior of articular cartilage.      The investigators evaluated 44 healthy males for their physical fitness levels and their     blood samples were obtained before, immediately after and 0.5 h after a 30-min walking     exercise. Thereafter, participants were assigned to the running, the cycling, the swimming     and the control groups. At the end of 12-weeks of intervention, same measurement procedures     were applied. Mixed repeated-measures ANOVA design was used for statistics. (Level of     evidence: 2)   "
130555|NCT01576146|"     The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly     intravenous (IV) administration of etelcalcetide in the treatment of secondary     hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of     treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).   "
130556|NCT01576133|"     The purpose of the study is to determine whether a combination of occupational therapy     visits, nursing visits, and handyman repair are effective in helping low income older adults     avoid costly health care services   "
130557|NCT01576120|"     The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using     the PillCam Colon system.   "
130558|NCT01576107|"     Impact of a 4-week exercise intervention vs. a stress-management-training on physical     activity (measured objectively and by questionnaire) of cancer patients of different entities     and out-patient regimes.   "
130559|NCT01576094|"     Congenital heart defects are the most prevalent group of congenital malformations in     newborns. Surgery-related low cardiac output syndrome (LCOS) could be one of the reason for     the unfavourable outcome of this population. The early use of inodilators (INDs),     specifically milrinone (MR), is proposed to reduce afterload and increase inotropism. Studies     in the paediatric population appear to support a clinical usefulness of MR similar to that     observed in adults. Levosimendan (LEVO) is a novel class IND developed for the treatment of     heart failure. Experience with LEVO in paediatric patients is scarce. The purpose of this     study was to systematically test the efficacy and safety of milrinone (MR) and levosimendan     (LEVO) in newborns undergoing cardiovascular surgery with cardiopulmonary bypass (CPB). Given     the uncertainty about LEVO pharmacokinetics in neonates, the study was designed as a pilot,     phase I feasibility study.   "
130560|NCT01576081|"     The present study aimed to investigate the importance of gravitational induced forces that     appear during normal ambulation for the health of muscles, bones and blood vessels. The main     hypothesis of the present study is that gravitational loading alone, without muscle     contractions, is insufficient to maintain bone strength.   "
130561|NCT01576068|"     Chronic Obstructive Pulmonary Disease (COPD) is a prevalent disease. In the investigators     country, underdiagnosis has been estimated in around 80% of subjects. Early detection is done     mainly in primary care but due to actual situation new alternatives have been proposed to     decrease underdiagnosis.      This present study promote by a multidisciplinary research team (respiratory medicine,     primary care, nurse and pharmacist) raise the objective of evaluate the effect of a COPD case     finding program guide by spirometry in community-pharmacies.      From the results of a pilot-study conducted in 13 community-pharmacies in Barcelona, in which     the investigators showed the feasibility of spirometry in community-pharmacies for the early     detection of COPD, the investigators have design a second phase to evaluate the effect of     this strategy. 100 Barcelona's community-pharmacies during 6 months will select high risk     customers and will conduct a spirometry in agreement with the design protocol. 3600     spirometries is the establish objective. Participants hospitals will train pharmacist in     spirometry and also control spirometry quality daily by a telematic pathway. Spirometry     results will be evaluate in terms of effect and costs. The investigators will also evaluate     the impact of this program in the health system by numbers of subjects diagnosed and follow     up in primary care.   "
130562|NCT01576055|"     The primary objective of the randomized study is to evaluate the safety and effectiveness of     the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions,     ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of     patients with symptomatic peripheral arterial disease (PAD).   "
130563|NCT01576042|"     The purpose of this pilot trial is to determine the feasibility of a large, multi-center     randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter     ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic     therapy at reducing all-cause mortality in patients with an implantable cardioverter     defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.   "
130564|NCT01576029|"     Primary Objective:        -  To compare the continuation of treatment with docetaxel versus switching to cabazitaxel          regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in          patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of          docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or          increase of up to 24% in PSA levels.      Secondary Objectives:        -  PSA response rate        -  Overall survival (OS)        -  Incidence of Adverse Events   "
130565|NCT01576016|"     The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety     and efficacy of the Accent MRI™ System in a patient population indicated for implant of a     pacemaker within and outside of the MRI environment.   "
130573|NCT01575912|"     Differences in pain perception between subjects with and without psychiatric illness may be     influenced by the individual experience, and not primarily by the pathology, although the     pathological frame may amplify it.The aim of this study is to establish if the     characteristics of experimental pain feeling are influenced by the past pain experience,     anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated     by an inventory of the potentially painful situations that one can come across through the     life, to determine the following points : Number of painful events in the past, number of     painful points during the last 6 months, number of painful events lasting more than 6 months,     sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum of     gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly     affective, mostly sensorial, or both).      Schizophrenic, depressed and control participants will be recruited, and their pain     experience throughout life will be put it in relation to experimental pain tests results     (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and     Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR)     variation, Blood Pressure (BP) variation.   "
130574|NCT01575899|"     This prospective controlled randomized open-label clinical trial is designed to determine the     eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen     compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in     Eastern Taiwan.   "
130575|NCT01575886|"     The goal of this study is to test an intervention that teaches clinicians to integrate the     use of 'teachable moments' with the key skills of motivational interviewing tailored to     address smoking and weight management in the primary care outpatient visit setting.   "
130576|NCT01575873|"     This study is being conducted in patients taking glucocorticoids for treatment of various     diseases. It is a 2-year study that will compare the effects of denosumab and risedronate.   "
130577|NCT01575860|"     This study is being conducted to evaluate the overall safety of lenalidomide (also known as     Revlimid) in patients with lymphoma, and to determine whether it is effective in preventing     this disease from returning after stem cell transplant. This study will also determine the     dose of lenalidomide that can be given without causing severe side effects. Lenalidomide has     not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of     lymphoma. At least 28 people will be enrolled on this study at the University of     Pennsylvania.   "
130590|NCT01575691|"     5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS).     Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the     effects of 5-aza. The goal of this clinical research study is to find the highest safe dose     of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and     all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness     of this combination therapy will also be studied.   "
130591|NCT01575678|"     Aim: To investigate the effect of melatonin in bedwetting.   "
130578|NCT01575847|"     This study is a non-intervention, clinical study to test research use only APAP protein     adducts dipsticks in human blood samples. The study will be conducted in two phases. In phase     1, the research use only dipsticks and dipstick testing components will be tested for     feasibility in the emergency department at UAMS. Patients will be enrolled that are having an     acetaminophen level obtained as part of their medical evaluation. In phase 2, the research     use only dipsticks will be tested in centers that participate in the Acute Liver Failure     Study Group (ALFSG), a clinical research network funded by the National Institutes of     Diabetes, Digestive and Kidney Diseases (NIDDK). Subjects participating in the clinical     registry of the ALFSG will be approached for enrollment. These patients all have the     diagnosis of acute liver failure or acute liver injury from a variety of etiologies,     including APAP. A single blood sample will be obtained and will be aliquoted for 1) testing     by the dipstick and 2) testing by high performance liquid chromatography with electrochemical     detection (HPLC-EC) analysis for APAP protein adducts. APAP levels will also be determined     from the second aliquot of blood. In both Phase 1 and Phase 2, the dipsticks will be read     manually and by dipstick readers by independent testers that are not directly involved in the     clinical care of the patients. The results of the two dipstick readings will be recorded,     will remain confidential and will not be used in the diagnosis or management of the patient.     The results of the dipsticks and HPLC-EC assays will be compared to the final patient     diagnoses.   "
130579|NCT01575834|"     The purpose of this study is to determine if treatment with romosozumab is effective in     preventing fractures in women with postmenopausal osteoporosis   "
130580|NCT01575821|"     Cough is a common symptom in pediatric practice. It can be particularly troubling to children     and their parents.It often results in discomfort to the child and loss of sleep to both the     child and the parent. The objective of this trial was to compare the effects on nocturnal     cough and the sleep difficulty associated with URIs of a single nocturnal dose of three     different honey products compared to placebo   "
130581|NCT01575808|"     The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment     of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be     measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured     by comparison to Surgical Bypass data derived from a retrospective study.   "
130582|NCT01575795|"     This is a multi-center, prospective, randomized, single-blind, investigator initiated,     pharmacodynamic study of parallel design, performed at 3 institutions (Patras University     Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).      Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing     primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present     high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary     intervention, will be randomized after informed consent, in a 1:1 ratio to either:      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6     hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose     (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at     randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow     assay, in platelet reactivity units (PRU).      Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent     revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic     Research Consortium criteria) will be performed until patient's discharge.   "
130586|NCT01575743|"     The aim of the present study is to investigate the impact of regular aerobic exercise on     psychopathology, cortisol secretion, BDNF, sleep, cognitive performance, and psychological     functioning in people suffering from professional burnout. Pre- and postassessments after 12     weeks of training will be performed.   "
130587|NCT01575730|"     Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable     patients with surgery followed by instillation of heated chemotherapy inside the abdominal     cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or     HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug     active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this     study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes)     may be safer and at least as efficient. Patients will be treated with one of three possible     HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low     dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using     specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will     be compared in order to establish the safest and most active HIPEC regimen.   "
130588|NCT01575717|"     The purpose of this study is to investigate the effect of two different doses of vitamin D3     (2000 IU vs. 4000 IU) on serum 25-hydroxyvitamin D (25OHD) levels in patients with     hepatocellular carcinoma on the liver transplant list. The study will help determine the dose     of vitamin D3 that is required for patients with liver cancer to reach a normal level of     25OHD in the blood.   "
130589|NCT01575704|"     The purpose of this randomized controlled two-part study examines the effects of a structured     sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in     children and adolescents.      The main aspects in the sports groups are resistance, endurance and flexibility training. The     control group performs a mental training as well as relaxation exercises.   "
131556|NCT01563042|"     An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics,     immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in     healthy male subjects   "
130592|NCT01575665|"     Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing     which has proven hard to treat effectively. The investigators hypothesised that by     periodically inducing normocapnia over several weeks, it would be possible to raise the     normal resting level/set point of CO2 and achieve a reduction of symptoms.      Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing     mask. The mask was used to induce normocapnia in these chronically hypocapnic patients.      Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline     and once each week at least three hours after mask use, as well as spirometric values, breath     holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire (NQ),.   "
130593|NCT01575652|"     The objective of this study was to examine the effects of angiotensin converting enzyme     inhibitors on peritoneal membrane transport, peritoneal protein loss, and proteinuria in     peritoneal dialysis patients.   "
130594|NCT01575639|"     Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal     treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no     consensus on the dosage of Prednisolone required for the treatment of infantile spasms.     Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual     dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses.     A higher steroid dose may also be associated with more side effects. Therefore, this study     was planned to compare the efficacy and tolerability of the high dose versus the usual dose     in children with infantile spasms, in a randomized open-label trial design   "
130595|NCT01575626|"     One important goal in anesthetic management during ocular surgery is to provide adequate     control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients     with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect of     anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist of     short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with     short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to     reduce the IOP. To this end there is no data in the literature to support or disprove this     finding.      Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant     effect on the IOP.   "
130596|NCT01575613|"     In this study, the investigators propose to determine the value of rolling out four targeted     malaria control efforts in reducing overall malaria transmission. These targeted control     efforts include local upscaling of IRS and ITNs in hotspots of malaria transmission. In     addition, larviciding will be employed to target malaria vectors, also those that are less     susceptible to IRS and ITNs as a consequence of outdoor feeding and resting. Lastly, the     human infectious reservoir will be reduced in hotspots of malaria transmission by treating     parasite carriers and their household members with the current first-line antimalarial drug.     The impact of these targeted interventions on overall transmission intensity will be assessed     in the context of currently ongoing malaria control activities in a plausibility study.     Hotspots of malaria transmission are defined in an area of 100km2 and randomized to receive     hotspot targeted interventions and compared with their baseline and with control clusters     where the routine (untargeted) malaria control activities continue. The interventions will be     evaluated based on changes in parasite prevalence measured in community surveys inside and     outside hotspots of malaria transmission. Parasite prevalence will be compared before and     after the intervention in intervention clusters and between intervention and control     clusters.      In addition to malaria surveys in the human population, an entomological evaluation will take     place where the densities of mosquito larvae and adult mosquitoes are monitored     longitudinally.   "
130597|NCT01575600|"     The purpose of this randomized clinical trial is to evaluate the interaction of intravenous     fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The     hypothesis is that perioperative supplemental intravenous fluid administration reduces the     incidence of postoperative vomiting.   "
130598|NCT01575587|"     The purpose of this study is to evaluate the effect of timing of food intake on systemic     abiraterone exposure observed in healthy adult Japanese and Caucasian men.   "
130599|NCT01575574|"     This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of     hepatocellular carcinoma   "
130600|NCT01575561|"     This is an open-label, multi-center,12 week extension study designed to evaluate the longer     term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to     lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either     completed the core study D1050296 or experienced a protocol defined recurrence of a mood     event in the double-blind phase of the core study D1050296   "
130601|NCT01575548|"     This randomized phase III trial studies how well pazopanib hydrochloride works compared to     placebo in treating patients with kidney cancer that has spread to other parts of the body     who have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow     to the tumor.   "
130602|NCT01575535|"     RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research trial studies bone marrow samples from women with acute myeloid     leukemia.   "
130603|NCT01575522|"     This phase II trial studies how well tivantinib works in treating patients with recurrent or     metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth.   "
130604|NCT01575509|"     This study aims to determine the 2 hour glycemic responses of two bread products and one     dried lingonberry product. The average postprandial response of each product is compared with     glycemic response after ingestion of control solution with a similar carbohydrate content     (glucose, glucose-fructose) as the provided by the respective test product.   "
130605|NCT01575496|"     The purpose of this study is to determine if repeated sessions of transcranial direct current     stimulation (tDCS) are effective for treating chronic subjective tinnitus. Previous studies     have reported brief improvements in tinnitus after safe and noninvasive stimulation of the     auditory cortex or limbic system. The investigators hypothesize that a greater improvement in     tinnitus will be achieved following repeated sessions of tDCS that target both auditory and     limbic systems.   "
130608|NCT01575457|"     The purpose of the Harriet Lane Clinic Healthy Futures Program is to increase academic or     workforce development success among adolescents and young adults. To this end, the Healthy     Futures educational intervention includes motivational interviewing and knowledge and skill     building activities that will focus on improving educational, vocational, health, and self     sufficiency outcomes for youth who attend the Harriet Lane Clinic. Goals of this youth     development project include determining what factors are associated with school engagement,     parental academic involvement, and future planning.   "
130609|NCT01575444|"     This proposal has been developed through collaboration between the University of Minnesota     and New American Community Services (NACS), and the research design is based on a needs     assessment conducted by the community partner. The investigators will test the hypotheses     that women who are offered home vaginal bio-specimen collection will have higher rate of     cervical cancer screening completion than that of women referred for clinic-based Pap test.     All participants will be given identical education materials on cervical cancer screening and     HPV, currently in use by the Minnesota Sage Program.   "
130610|NCT01575431|"     The aim of this study is to prospectively investigate the relationship of circulating     endothelial progenitor cells at time of percutaneous coronary intervention to the subsequent     development of in-stent restenosis or progression of coronary atherosclerosis.   "
130611|NCT01575418|"     This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied     tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal     formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be     enrolled.      Each participant will receive two inpatient doses of each radiolabeled study product. The     first inpatient dose of each product will be administered without coital dynamics simulation     (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post     dose with instillation of radiolabeled autologous semen. There will be a washout period of at     least 11 days between each dose.   "
130612|NCT01575405|"     This is a double-blinded, randomized, safety, acceptability, pharmacokinetic, and ex vivo     efficacy study of three rectally-applied tenofovir-based microbicide formulations.     Approximately 18 total evaluable HIV-negative men and women (~9 per site) will be enrolled     across two study sites: University of California at Los Angeles (UCLA) and Magee-Womens     Research Institute (MWRI) at University of Pittsburgh.      Each participant will experience seven rectal exposures to the rectal-specific formulation     (RF) and seven rectal exposures to the reduced glycerin vaginal formulation (RGVF) of     tenofovir 1% gel, but only one exposure to the vaginal formulation (VF), which will be     coupled with six preceding exposures to the Universal HEC Placebo Gel to balance out the VF     study stage. Participant accrual will take approximately 6 months and each participant will     be on study for approximately 3 months. The total duration of the study will be approximately     1 year.      The primary objectives of the study are safety, acceptability, and pharmacokinetics,     specifically:        -  To evaluate the safety of each tenofovir-based microbicide gel formulation when applied          rectally        -  To evaluate the acceptability of each tenofovir-based microbicide gel formulation when          applied rectally        -  To compare systemic and compartment pharmacokinetics among the three tenofovir-based          microbicide gel formulations when applied rectally      Secondary objective of the study is to evaluate the mucosal immunotoxicity of each     tenofovir-based microbicide gel formulation when applied rectally.      And the exploratory objective of the study is to assess the preliminary (ex vivo) efficacy of     each tenofovir-based microbicide gel formulation using biopsy explants after each product is     applied rectally.   "
130628|NCT01575184|"     Internal jugular vein (IJV) catheterization is frequently performed in infants undergoing     major surgery. Although it has been suggested that head rotation increases the degree of     overlapping between IJV and carotid artery (CA), IJV catheterization without head rotation is     extremely difficult in infants. The aim of the present study is to evaluate whether the     caudo-lateral traction of the ipsilateral arm can decrease the degree of overlapping between     IJV and CA in infants during head rotation.   "
130694|NCT01574534|"     The investigators hypothesize that in a real-world population undergoing percutaneous     coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter <3     mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents     (DES).   "
130613|NCT01575392|"     In clinical practice the 24-hour creatinine clearance is often used to obtain an impression     of renal function. However, the glomerular filtration rate is considered to be the best     indicator of renal function. For practical and financial purposes, GFR is often estimated by     means of serum creatinine based equations. These equations are also used in internation     guidelines to define and classify chronic kidney disease. Therefore, accurate creatinine     measurements are important to make reliable estimates of renal function. However, previous     research has revealed a large variability in creatinine measurements using different     measuring methods. In this study the investigators aim to establish the degree of variability     in different methods to measure creatinine in a heterogenous group of Caucasian people with     and without renal function loss and the influence of this variability on renal function     estimating equations and the 24-hour creatinine clearance.   "
130614|NCT01575379|"     Recent evidence from epidemiological studies suggests that serum uric acid levels higher than     average predispose diabetic patients to kidney damage. The purpose of this study is to gather     preliminary information on whether lowering serum uric acid by means of oral allopurinol (a     drug commonly used for the treatment of gout) can be used to prevent or delay the loss of     kidney function that may accompany diabetes. The results of this study will help us design a     larger study to find out whether this medication can prevent kidney problems, in particular     the loss of kidney function, in people with type 1 diabetes.   "
130615|NCT01575366|"     Aim 1. Determine whether higher-velocity finger tracking training improves hand function more     than slower velocity training. Working hypotheses: The higher-velocity training will have     significantly greater functional improvement compared to the lower-velocity training, as     measured by standardized upper extremity functional tests (Jebsen Taylor test, Box & Block     Test, and Finger extension force test)      Aim 2. Ascertain whether higher-velocity finger tracking training differentially induces     cortical reorganization as compared to lower-velocity finger tracking training.      Working hypotheses: The higher-velocity training will have significantly greater cortical     reorganization compared to the lower-velocity training, as measured by:        1. TMS - increased amplitude of motor evoked potentials (MEP) from paretic extensor          digitorum muscle in response to paired-pulse TMS to ipsilesional primary motor area          (M1).        2. fMRI - increased volume of activation, signal intensity, and laterality of ipsilesional          M1.      Aim 3. Explore whether the functional improvements correlate with the cortical     reorganization. Working hypotheses: The functional improvements will correlate with the     cortical reorganization.   "
130616|NCT01575353|"     The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and     Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is     that nasal high-flow may be superior to the Venturi mask in terms of oxygenation   "
130618|NCT01575327|"     The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen     Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in     patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia.      The study was designed to test the following hypotheses:      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher     exercise tolerance (distance during ESWT) and lower desaturation events without increase in     hypercapnia in patients with COPD, oxygen therapy and hypercapnia.      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea     and leg fatigue scores at a given endurance time during the shuttle walking test in patients     with COPD, oxygen therapy and hypercapnia.      As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac     and respiratory frequencies at a given endurance time during the shuttle walking test in     patients with COPD, oxygen therapy and hypercapnia.   "
130619|NCT01575314|"     The purpose of this study is to compare the efficacy and cost difference of using a     parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with     lung disease (mass or others).   "
130620|NCT01575301|"     The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and     to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.   "
130621|NCT01575288|"     The proposed study will assess the ability of a naturally occurring sugar to improve the     function of arteries with age. Overall, the proposed research project has the long-term     potential to influence clinical practice guidelines by establishing a novel, easy to deliver,     cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk     of cardiovascular disease with age.   "
130622|NCT01575275|"     The purpose of this study is to investigate the safety and performance of an investigational     agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for     visualizing a tumor during surgery. It is also being studied to determine if there are     differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance     imaging (MRI)   "
130623|NCT01575262|"     The purpose of this study is to investigate the effectiveness of using incentives to     encourage adults to be physically active.   "
130624|NCT01575249|"     The investigators aim to identify all clinical, biological, echo and imagistic parameters     that predispose to increased progression rates in a prospective observational trial which     will include ONLY patients with moderate AS, with the complete cardiological investigational     tools provided in 2012. Once those parameters are found, medical and interventional treatment     could be implemented to decrease the mortality rates.   "
130625|NCT01575236|"     The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,     fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the     LMA SupremeTM in paralyzed, anesthetized patients.   "
130626|NCT01575223|"     Purpose: To determine if high volume saline nasal irrigation (HVSI), (NeilMed® Sinus Rinse™)     offers a benefit over low volume saline irrigation (LVSI), (Salinex®) in the early     post-operative management in patients with chronic rhino sinusitis.   "
130627|NCT01575197|"     The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on     alternate dosing schedules will enhance the immune response to the vaccine in a low-resource,     high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose     vaccine schedule at a slightly older age and giving an additional dose of the vaccine.   "
130629|NCT01575171|"     Behavioral economics represents a powerful, albeit underutilized tool to influence provider     and systems behavior in a large-scale, meaningful, and sustainable way. The investigators     propose to use a sophisticated electronic health record (EHR) system to change the default     choice for physicians to the choice most supported by clinical practice guidelines (CPG).      Multiple guidelines exist describing best practices for effective interventions, yet a large     gap persists between actual and optimal guideline compliance. The proposed study will examine     the comparative effectiveness of an opt-out medication management protocol relative to usual     care for patients not at goal, using national guidelines for cholesterol management     implemented in large multispecialty private practices that use an Electronic Health Record     system.      Specific Aim: To determine the effectiveness of altering the default option in an EHR in     prescribing statins to selected patients using clinical decision support.      Hypotheses: Compared to usual care, a CPG-concordant intervention designed using behavioral     economics principles will significantly improve the proportion of patients who are prescribed     statins.   "
130630|NCT01575158|"     citalopram and clomipramine are better than placebo in preventing new episodes of depression     in patients with recurrent depression   "
130631|NCT01575145|"     The study is being done to determine whether an in-hospital intervention using a brief     intervention to facilitate quitline utilization will increase quitline utilization by     hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.      Study participants will be randomized to receive either a brief quitline facilitation     intervention , or a control intervention of a brief stop-smoking message.      The study will also compare healthcare costs and utilization in the first six months     following hospitalization between the two groups.   "
130632|NCT01575132|"     The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS)     for patients with Parkinson's Disease. We have data for patients operated with DBS since     1998. We wish to examine the effect of stimulation on motor symptoms as well as make a     follow-up on complications and side-effects related to treatment. We also wish to follow-up     on the quality of life-studies made in the years 2003-2008.   "
130881|NCT01571882|"     The objective of this study is to investigate the effect of consumption of a low-fat, no     added sugar, dairy fermented product enriched with plant sterols and policosanols at two     doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of     product consumption versus active control product.   "
130633|NCT01575119|"     Smokers have three choices when faced with surgery: keep smoking, quit for a short time     around surgery or quit for good. In the first specific aim, a decision aid was designed to     help facilitate the discussion of these choices between smokers and healthcare providers.     This second aim will test whether this decision aid improves the decisional quality compared     with standard methods used to discuss perioperative smoking.   "
130634|NCT01575106|"     This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how     contextual learning/expectation relieves or aggravates pain experience in the same cohort of     subjects and the same study session.   "
130635|NCT01575093|"     This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2     Capsule Endoscopy.   "
130636|NCT01575080|"     The purpose of this study is to determine if untrained subjects who have diabetes can operate     the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.   "
130637|NCT01574040|"     Rationale: Lifestyle modifications, such as increasing physical exercise and reducing dietary     salt and saturated fat intake contribute to prevention of cardiovascular morbidity and     mortality. Relevant improvements can already be achieved by small adaptations in everyday     life. It is unclear whether simple low-cost interventions in the working environment can     promote such healthy lifestyle adaptations.      Objective: To study the effect of low-cost interventions for promoting healthy lifestyle     modifications.      Study design: Before-and-after intervention study. The study period will be subdivided in     four parts of 2 weeks each: a run-in period, a before-measurement period, an     intervention-period, and an after measurement period.      Study population: Staff and visitors of the University Medical Center Utrecht.      Study interventions:        -  Promotion of stair climbing.        -  Promotion of a low-salt soup alternative for the 'soup of the day'.        -  Promotion of a low-fat alternative for the butter croissants.        -  Exchange of the basket positions of butter and margarine between convenient and harder          to reach locations.      Outcome measures:        -  Number of passages through each part of the stair cases.        -  Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant          and ratio between them.        -  Number of low-fat and normal croissants sold in the hospital restaurant and the ratio          between them.        -  Number of low-fat margarine servings and butter servings sold in the hospital restaurant          and the ratio between them.   "
130638|NCT01574027|"     Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30     years, but has never been directly studied in humans. The biologically active version of     vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause     serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side     effect. The investigators previous research suggests that the enzyme necessary to convert     25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine     (colon).      Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped     cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely     uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not     fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC     decreases.      The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or     placebo, and determining if there is a drug-dependant decrease in ACF number. The primary     objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to     placebo, causes significant reduction of ACF number from baseline levels. The primary     endpoint will be change in ACF number.   "
130652|NCT01573845|"     The central hypothesis of The GREEN Project Lunch Box Study is that a school-based     communication campaign that combines healthy eating and eco-friendly messages will improve     the quality of foods that children bring from home to school more than a healthy eating     campaign alone and compared to a control/delayed intervention condition at the end of one     school year.   "
130639|NCT01574014|"     Social phobia is the third most common psychiatric disorder besides depression and     alcoholism. Several studies have demonstrated the efficacy of cognitive-behavioral therapy in     the treatment of social phobia. Nevertheless, there is no effect in a third of the people at     the existing treatment methods. Pharmacological therapies have similar effects, but there is     a high rate of relapse after discontinuation of medication.      Social phobia is characterized by fear of performance or interaction situations. The strong     fear of negative evaluation by others is usually accompanied by a marked avoidance behavior     and increased physical symptoms such as blushing, sweating, palpitations, or tremors. The     confrontation with a phobic stimulus leads to a retrieval of stimulus-associated aversive     memories, resulting in an immediate anxiety response. Several studies had already shown that     elevated glucocorticoids impair retrieval of declarative memory contents in healthy subjects.     The investigators demonstrated an anxiety-reducing effect after the administration of     cortisone before the confrontation with a phobic stimulus in patients with social and spider     phobia.   "
130640|NCT01574001|"     The primary objective of the present randomized controlled trial is to compare the     effectiveness of three anti-smoking interventions of different intensities. It has been     hypothesised that early follow-up visits facilitate post-stroke smoking cessation in patients     hospitalized because of first-ever ischemic stroke.   "
130641|NCT01573988|"     In this study, the investigators are interested in assessing the effects of the isocaloric     increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric     breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese     subjects through :        -  the physiological consequences : difference in postprandial kinetics of glucose, non          esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin,          ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1          (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA),          glutathion, lipid hydroperoxides)        -  eating behavior during an ad libitum buffet test meal   "
130642|NCT01573975|"     The purpose of this study is to compare the eradication efficacy of 10-day triple therapy     with 10-day sequential therapy with tetracycline or metronidazole.   "
130643|NCT01573962|"     The objective of this sample collection study is to collect blood and urine samples. This     study is observational and will have no impact on the medical management of the subject.   "
130659|NCT01574989|"     In this study the investigators aim to investigate the effects of two different types of     non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation     (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This     is a cross-over study where subjects will receive 5 sessions of stimulation (each separated     by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham     tDCS and rTMS.   "
130644|NCT01573949|"     The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will     assess the use of the medication metformin to improve quality of life, exercise capacity, and     improved outcomes in heart failure patients with pre-DM or early DM (type II).      If the patient participates in this study, the patient will receive the drug metformin for     approximately 3 months. During the study the patient will undergo comprehensive testing which     includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The     patient must be 18 years old to participate.   "
130645|NCT01573936|"     The purposes of this study were to evaluate the influence of an interdisciplinary     rehabilitation program in the improvement of the health-related quality of life among adult     neurological patients and to identify the sociodemographic and clinical associated     characteristics. Subjects with spinal cord injury, acquired brain injury and poliomyelitis     survivors participated in the study. All participants underwent a rehabilitation program (RP)     from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2     days a week. The WHOQOL-BREF was applied at the initial and discharge assessments.   "
130646|NCT01573923|"     Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality     worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel     therapies are necessary to prevent or block the process of the disease. In this current     prospective cohort, the investigators plan to organize four hospitals to determine the safety     and efficacy of intravenous administration of umbilical mesenchymal stem cells in the     treatment of patients with liver cirrhosis in next three years.   "
130647|NCT01573910|"     The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the     treatment of bacterial conjunctivitis in Chinese patients.   "
130648|NCT01573897|"     Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low     transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor     for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and     sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing     the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2     between the end of the night and midday in patients with -or at risk of- diabetic foot wound     according to the presence or not of sleep apnea syndrome.The secondary objective is to     address the microvascularisation of diabetic patients having foot wounds according to their     status regarding sleep apnea syndrome.   "
130649|NCT01573884|"     -  Exploratory analyses of the immune response in a ex vivo culture system        -  Characterization of the composition of maternal milk and infant urine   "
130650|NCT01573871|"     The objective of the study is to assess gastrointestinal tolerance and compliance in infants     who require a hydrolyzed formula.   "
130651|NCT01573858|"     The objectives of the present trial are to test the following three hypotheses in anovulatory     women with PCOS:        1. Acupuncture protocol 1 plus CC (Arm A) is more likely to result in live birth than          acupuncture protocol 2 combined with CC (Arm B),        2. Acupuncture protocol 2 plus CC (Arm B) is more likely to result in live birth than          acupuncture protocol 1 plus placebo (Arm C),        3. Acupuncture protocol 1 plus placebo (Arm C) is more likely to result in live birth than          acupuncture protocol 2 plus placebo (Arm D).   "
130653|NCT01575067|"     The purpose of this study is to monitor the blood pressure level of the patient using a     preformed cuff ranged 22 cm-42 cm.   "
130654|NCT01575054|"     This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult     post-stroke lower limb spasticity.   "
130656|NCT01575028|"     This study is a prospective, double-blinded, randomized comparison of 2 patient cohorts. One     group of patients will receive a transversus abdominis plane (TAP) block. The second group     will receive local anesthetic infiltration injected at the surgical site by the surgeon at     the end of surgery for a laparoscopic appendectomy. The purpose of this study is to     prospectively compare post-operative pain relief in pediatric patients undergoing     laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block     or local anesthetic infiltration by the surgeon for analgesia to compare the most appropriate     delivery of effective analgesia. In an effort to improve postoperative analgesia while     limiting opioid-related adverse effects, there continues to be an increased use of multimodal     techniques in infants and children.   "
130657|NCT01575015|"     Patient with liver failure waiting for liver transplantation are often hospitalized and     commonly supported in an intensive care unit prior to surgery. These patients are sick, and     in addition to the complications of a failing liver, other organs such as the kidneys often     fail as well. As a consequence, these patients are at an increased risk for complications     related to their kidney failure during their liver transplantation procedure. One potential     method to diminish the risk of these complications is to provide dialysis support to these     patients during their liver transplantation in the operating theater in the form of     continuous renal replacement therapy (CRRT). While this is increasingly being performed and     is theoretically appealing, there is very little information to support this practice. In     addition, the use of CRRT during surgery is not entirely without risk. The investigators have     performed two preliminary studies on the use of CRRT during liver transplantation and our     data would strongly support the need to conduct further higher-quality studies to better     evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial     comparing the use of CRRT during surgery with standard supportive care in sick patients with     liver failure scheduled to receive a liver transplantation.   "
130658|NCT01575002|"     In this study the investigators aim to examine the effects of Transcranial Direct Current     Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in     individuals with chronic pain of the cornea -- and also compared with healthy controls.   "
130660|NCT01574976|"     The purpose of this study is to determine how feedback and practice affect decision making in     adolescents with attention deficit and hyperactivity disorder.      Participants will have to choose between low and certain outcome and a higher but uncertain     outcome, with or without serial feedback after each trial. Participants will perform the task     twice to examine practice effects.   "
130661|NCT01574963|"     Osteoprotegerin (OPG) is membrane bound in the immune system but can also be produced and     secreted almost everywhere in the organism, so that it is mainly available in soluble form.     So far, the OPG/RANKL/RANK system has been most intensively studied in bone. The binding of     RANKL on its receptor RANK, which is expressed by osteoclasts, activates a number of     osteoclastic cell functions. OPG also has a key function in the vascular system. Patients     with coronary heart disease (CAD) have elevated OPG serum levels, probably as a sign of     ischemic or inflammatory endothelial damage. Elevated OPG levels were also found in patients     with advanced heart failure, whereby OPG correlated with pro BNP (brain natriuretic peptide)     and was a predictor for cardiovascular morbidity and mortality.      Our prospective cohort study will include 150 men (75 patients requiring surgery for CAD and     a control group without coronary heart disease). The primary endpoints are the differences     between the two groups in serum levels of OPG and RANKL, markers of bone metabolism     (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH)     vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to     vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density. Metabolomic     based biomarkers will be evaluated to explore the mechanisms behind OPG-RANKL linked CVD     damage. In the patients further studies of the mRNA expression of OPG, RANKL, TRAP5b,     arginine:glycine amidinotransferase (AGAT) and osteocalcin in bone (sternum sliver) and     vascular wall (aorta, internal thoracic artery and the great saphenous vein) will be     performed.      A further study endpoint is the analysis of a causal coincidence between osteoporosis and CAD     and the discrimination of possible key factors in the two entities. These will be determined     by the correlation between the above-mentioned markers in serum and the expression in     different vessels and in bone tissue.      In addition to analysis of the degree of vascular sclerosis, the mineral content of the bone     will also be analyzed in a subpopulation with quantitative backscattered electron imaging     (qBEI) related to the degree of vascular sclerosis and bone mineral density. The ultimate     goal of the analysis is the discrimination of the most sensitive predictive marker(s) for     diagnosis and outcome of patients with CAD for the purpose of early diagnosis and primary     prevention of the disease.      CAD and osteoporosis are increasingly prevalent diseases that overlap. In both entities, OPG     plays a role not only in pathogenesis but also as an outcome predictor. We aim to study the     relevance of OPG concentration in serum but also in the vessel wall and the bone.   "
130662|NCT01574950|"     Delirium (confusion) after surgery is common and associated with a longer hospitl stay and     increased hopsital cost. There is very little information available about how often delirium     occurs and the complications associated with it. Elderly patients are at high risk for     delirium after surgery. This research is being done to measure how often delirium after spine     surgery occurs and to see if there are ways to predict if delirium will develop. The results     from this study will provide important information on a possible mechanism and predictor of     delirium.   "
130663|NCT01574937|"     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of     an investigational drug. Phase I studies also try to define the appropriate dose of the     investigational drug to use for further studies. Investigational means that the drug is     still being studied and that research doctors are trying to find out more about it. It also     means that the FDA (U.S. Food and Drug Administration) may not have approved this drug for     use in participants, including people with your type of cancer.      In this research study, we are testing the safety of XL184 at different dose levels. XL184 is     a new study drug, which is taken by mouth. Laboratory studies have shown that XL184 may     prevent tumor growth by stopping the formation of blood vessels inside the tumor and also     shrink tumors.      This drug has been used in early-stage studies and is also currently being studied in other     trials. Information from those other research studies suggests that XL184 may help to slow or     stop tumor growth including prostate cancer. We will also be taking blood and urine tests to     look at how your body processes the drug.   "
130664|NCT01574924|"     The Ethics Committee of Hospital and University Center of Coimbra (Portugal) complies,     reports and is supervisioned by the Portuguese Ethics Committee.      The Ethics Committee of Hospital and University Center of Coimbra is an multidisciplinary     organ of Ethics experts that give support to the board of hospital directors, the health     personnel and patients, regarding bioethical issues emerging from clinical assistance     activities (addressed to patient's health being, education and clinical research).   "
130709|NCT01574339|"     The EndoStim LES Stimulation System is an investigational device intended to improve the LES     pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from     Gastroesophageal Reflux Disease (GERD).   "
130665|NCT01574911|"     Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The     objective of this project is the validation of real-time reconstruction and calculation of     limb volume using a 3D laser scanner.      Water - displacement volumetry (water-filled boot) is the reference method with known     accuracy and reproducibility, but is not commonly used in clinical practice because it is     cumbersome, difficult, and time-consuming. The most commonly used method remains segmental     limb perimetry with a tape measure, followed by volume calculation using the truncated cones     formula, thus excluding de facts extremities (hands and feet) which can neither be likened to     cones nor easily measured.      Quantification limb volume and volume changes is essential for the diagnosis and follow-up of     patients with chronic venous insufficiency or lymphedema, two very common pathological     conditions. It is mandatory for the evaluation of therapeutic approaches.      The present study will use an innovative technology of volume acquisition by freehand laser     scanning with a hand-held camera with Quantification limb volume and volume changes is     essential for the diagnosis and follow-up of patients with chronic venous insufficiency or     lymphedema, two very common pathological conditions. It is mandatory for the evaluation of     therapeutic approaches.      The present study will use an innovative technology of volume acquisition by freehand laser     scanning with a hand-held camera with real-time 3D reconstruction.      Its advantages are non-contact, accurate and detailed quantification of edema, including     extremities, allowing to assess the magnitude and topography of physiological, pathological,     or treatment - induced volume changes. This approach will ultimately provide data that will     used for designing personalized limb compression ortheses.   "
130666|NCT01574898|"     The purpose of this study is to determine the pharmacokinetic profile of nicotine following a     single oral administration of three new nicotine lozenge formulations (V0474) in comparison     with two reference products. The clinical and biological safety of V0474 and the lozenge     acceptability will also be assessed.   "
130667|NCT01574885|"     The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo     treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least     six months.   "
130668|NCT01574872|"     The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the     prognosis of inverse psoriasis or sebopsoriasis present for at least one year   "
130669|NCT01574859|"     Retrospective trial of 300 patients with pituitary insufficiency treated in Department of     Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4)     replacement and cardiovascular risk factors. The hypothesis is that subtle central     hypothyroidism is associated with adverse cardiac risk factors, such as body composition and     serum lipids, and that improved T4 replacement will eliminate this increased risk,     independently of other pituitary hormone replacements.   "
130670|NCT01574846|"     The aim of this non-interventional (observational) study is to document, in collaboration     with established urologists in Scandinavia, experience gained from routine use of Vantas® for     the treatment of patients with advanced prostate cancer. In this observational study     particular attention will be directed to treatment duration, quality of life and patient and     physician acceptance of the medicinal product for long-term therapy. Patient-based     measurement parameters such as quality of life and degree of satisfaction will allow     registration of information that extends beyond the clinical parameters. The knowledge     gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical     outcome will also be documented by measuring serum testosterone and prostate specific antigen     (PSA) levels.   "
130671|NCT01574833|"     The investigators hypothesized that early applied pulsed electromagnetic field treatment on     delayed union might lead to increased rate of fracture union and shortened period of     treatment.   "
130672|NCT01574820|"     Objectives:      The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial     for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).      Background:      Microvascular and macrovascular complications are common in type 2 DM. There is no evidence     about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ     activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory     process activators) on pre-DM patients with documented CAD.   "
130673|NCT01574807|"     The inferior alveolar nerve block (shot) is the most frequently used injection technique for     achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection     does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study     has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of     injection (shot). The investigators propose to compare an injection of mepivacaine followed     by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a     difference in effectiveness.   "
130674|NCT01574794|"     The goal of this study is to understand the effects of muscle strengthening and stretching     exercise intervention on isometric muscle strength, joint flexibility and running     biomechanical patterns in older recreational runners. To do so, the subjects will be assessed     before and after they engage in a 8-week exercise intervention program.   "
130675|NCT01574781|"     The primary purpose of this study is to collect maternal blood samples from pregnant women to     develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal     blood.   "
130676|NCT01574768|"     The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment     of snore and OSAS.   "
130677|NCT01574755|"     APC of gastric inlet patches is successful for the treatment of globus sensations in the     throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term     efficiency of this treatment. To measure long term efficacy all patients treated with this     therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.   "
130691|NCT01574573|"     By affecting the gastroesophageal pressure gradient, obesity predisposes to reflux of gastric     contents. The investigators hypothesized that the loss of weight will decrease this gradient     and as a result decrease the severity and frequency of GERD symptoms. GERD negatively affects     health related quality of life. Since loss of weight may decrease gastroesophageal reflux,     the investigators hypothesized that it obesity contributes to poor quality of life in GERD     subjects and losing weight should also favorably impact and improve quality of life in GERD     patients.   "
130678|NCT01574742|"     A single center, open label study assessing the feasibility, safety and therapeutic effect of     Minocycline in adult patients with diagnosis of unipolar depression. Up to 30 patients     diagnosed with unipolar depression that are in a current depressive episode. The patients     will be of all racial, ethnic and gender categories, ranging from 18 to 68 years of age, and     have HDRS-21≥20. All subjects will continue to take their treatment with antidepressant     medications for the duration of the study. All subjects are prescribed minocycline 200 mg/day     orally (2X100 mg) for the first 3 days. than, all subjects are prescribed minocycline 400     mg/day orally (2X200 mg) from day 4 until termination visit (day 35). The primary objective     of this study is to assess the therapeutic effect of Minocycline in unipolar depression.      The secondary objectives of this study are to assess the therapeutic effect, the feasibility     and safety of Minocycline in unipolar depression.   "
130679|NCT01574729|"     The primary objectives of this study are to investigate the efficacy and safety of surgery     combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma     (NSCLC). The study efficacy endpoints include overall survival, progress-free survival,     quality of life, and local recurrent rate. The safety endpoint is complications and adverse     effects.      The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the     local recurrent rate.   "
130680|NCT01574716|"     This study is being done to see if MORAb-004 increases the effectiveness of the     chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.   "
130681|NCT01574703|"     Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety     for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total     of 52 weeks of cardiovascular safety data collection.   "
130682|NCT01574690|"     The purpose of this study is to establish the accuracy of a non-invasive device that uses     near infrared spectroscopy (NIRS) to estimate central venous pressure (CVP) comparing it to     physical exam and invasive hemodynamic measurement via right heart catheterization (RHC).   "
130698|NCT01574482|"     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable     low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in     mildly hypercholesterolemic people treated or not by statins   "
130699|NCT01574469|"     The purpose of this study is to investigate the effect on cholesterolemia profile of a low     fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in     mildly hypercholesterolemic people treated or not by statins.   "
130700|NCT01574456|"     The main aim of the present study is to improve our understanding of the role of blood-brain     barrier function in dementia of the Alzheimer's type. The investigators hypothesize that     microvascular dysfunction - more specifically cerebral perfusion and blood-brain barrier     leakage - is a determinant of cognitive decline and cortical atrophy in Alzheimer's disease.   "
130683|NCT01574677|"     Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and     affects men and women almost equally. The United States Preventative Services Task Force     (USPSTF) currently recommends screening with any of three options, which include fecal     testing, flexible sigmoidoscopy, or colonoscopy.      Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually     or biennially has been shown to decrease mortality 15-33% primarily through detection of     early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of     benefit and risk in screening populations, is the least expensive, and is the preferred     method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers     significant improvements over the gFOBT, most notably that it is easier to use (requires     fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT     with respect to detecting both CRC and precancerous adenomas. As a result of improved test     performance and usability, in 2008 multiple professional societies endorsed the use of four     types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro     FIT as the fecal screening test in all regions.      In recent years, intensive efforts have been undertaken to identify blood-based markers that     may provide a promising alternative or supplement to fecal testing for non-invasive CRC     screening. One method under development is to identify aberrantly methylated genes in cancer     tissue through a blood test. Prior studies have explored those specific colorectal cancer     genes that show the highest differences in methylation between the cancer and background     genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is     relatively well studied.      The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement     the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded     colonoscopies. The population of interest for this study—those with a positive screening     OC-Micro fecal immunochemical test—has a CRC prevalence of approximately 5%. Knowing how well     Septin 9 can identify those without cancer prior to colonoscopy is important largely because     colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause     serious complications.   "
130684|NCT01574664|"     The goal of this investigation is to obtain clinical data to show the Health Beacons     Radiofrequency Identification (RFID) Localization System is safe and performs as intended as     a localization device for marking and retrieving a non-palpable surgical target from the     breast.   "
130685|NCT01574651|"     This study will assess the efficacy and safety of QVA149 compared to tiotropium plus     formoterol in patients with moderate to severe COPD.   "
130686|NCT01574638|"     This study will evaluate two different ways to give rifapentine (RPT), a drug that may help     shorten treatment duration for tuberculosis (TB) disease.   "
130687|NCT01574625|"     A Single Center Non-Interventional Post-Market Release, Long Term Follow Up study of patients     who underwent Isolated Aortic Valve Replacement or Isolated Mitral Valve Replacement with a     Medtronic Mosaic Bioprosthesis. The purpose of this study is to evaluate the long term     safety, efficacy and clinical performance of the Mosaic Bioprostheses.   "
130688|NCT01574612|"     To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of     recurrent cold sores in children ages 6-11yrs after 5 days of treatment.   "
130689|NCT01574599|"     The purpose of this study is to assess whether a novel therapy approach (repetitive     facilitative exercise (RFE)) is more effective than conventional rehabilitation in     facilitating the recovery of upper extremity function following stroke.   "
130690|NCT01574586|"     The primary objective of this study is to make a comparison of safety and efficacy of DESs     with different link number (2-link Nobori and 3-link Xience) in patients with de novo true     bifurcation lesions.      The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE     rate until one year after PCI will be assessed in both groups.   "
130692|NCT01574560|"     Smoking is widely accepted to cause an increase in an individual's likelihood of developing     cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand     smoke inhaled by a non-smoker has also been associated with the development of several     illnesses. This study focuses on learning how to make your home smoke-free.   "
130695|NCT01574521|"     Animal experiments demonstrated that father might transmit HBV vertically via male germ line,     however, whether it is really existed in human remains to be determined. Since HBV is a     blood-borne virus, the unvaccinated pregnant women would be at risk for HBV exposure if their     fetuses carried the virus from fathers. If women had been vaccinated for HBV before     conception, what would happen to a maternal immune system if her fetus carried HBV from     spermatozoa? However, the literature on transmission of HBV by spermatozoa in vivo is rare,     the viral replicating status and fetal immune response in uterus are unknown. The aim of     study was to detect father-to-fetus transmission of hepatitis B virus (HBV) in uterus.   "
130696|NCT01574508|"     The current study will compare the different efficacy of two transient intensive insulin     treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily     insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic     agents.   "
130697|NCT01574495|"     This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that     leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer     singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus     forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system     which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's     desired trajectory can be determined and the movement errors can be amplified in real-time     with dramatic results. This project evaluates a practical approach of error augmentation,     using therapist-driven trajectories. The investigators intend to determine clinical efficacy     of several types of therapist-assisted error augmentation on retraining the nervous system in     functional activities. The investigators will test two experimental treatments in a crossover     design. The investigators hypothesize that combined haptic and visual error augmentation will     lead to the best functional recovery.   "
130701|NCT01574443|"     The principle aim of this project is to characterize the changes in relative stability of the     intrinsic brain dynamics during onset of sleep and induction of general anesthesia. The     investigators hypothesize that brain dynamics in the awake state are critical akin to     physical systems close to a second order phase transition and that during loss of     consciousness the dynamics move away from the critical point.   "
130702|NCT01574430|"     The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin     dose in the treatment of CSC.   "
130703|NCT01574417|"     Plant sterols and stanols are dietary components that are naturally present in plants. Their     biological function in plants is comparable with these of cholesterol in animals. They are     structurally related to cholesterol, but are absorbed by enterocytes to a much lesser extent.     It is generally accepted that they inhibit intestinal cholesterol absorption and consequently     lower serum low-density lipoprotein (LDL) cholesterol concentrations up to 10% at daily     intakes of 2.5 g. The exact underlying mechanism of the plant sterol/stanol mediated     reduction in intestinal cholesterol absorption is still unknown. It has been suggested that     they lower the activity of sterol uptake transporters like Niemann-Pick C1 like 1 protein     (NPC1L1) in enterocytes, otherwise several studies indicated that these compounds could     activate the liver X receptor (LXR) in enterocytes, thereby activating the ABC transporters     involved in the intestinal cholesterol metabolism, whereas recently suggestions have been     made that plant sterols and stanols activate transintestinal cholesterol excretion (TICE).     This is the direct cholesterol secretion from the blood into the intestinal lumen, in which     the enterocytes play a central role. None of these assumptions have so far been evaluated in     humans.      Objective: The major objective of the present study is to examine the acute effects of     dietary plant stanol esters on the intestinal mucosal gene expression profiles in intestinal     biopsies in healthy volunteers. The minor objective is to investigate whether semi-long-term     use (3 weeks) of plant stanol esters have an effect on microbiota composition.   "
130704|NCT01574404|"     People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a     method called preimplantation genetic screening (PGS) before they are implanted in the uterus     to possibly increase their chances of having a successful pregnancy. One or more cells are     removed from the embryo. The chromosomes inside the cells are then tested to identify normal     or aneuploid embryo(s).      The investigators propose to evaluate a test called micro array analysis on the chromosomes     of the first polar body. This method tests part of the egg that would normally be lost and     may help us choose the embryo most likely to become a healthy baby.   "
130705|NCT01574391|"     The purpose of this study is to determine whether the use of the Epidrum device to identify     the epidural space in labouring parturients reduces morbidity, when compared to standard loss     of resistance techniques.   "
130706|NCT01574378|"     VLock suture studied in abdominal wound closure. Time and cosmesis was studied   "
130707|NCT01574365|"     A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes     mellitus.   "
130708|NCT01574352|"     Strong and consistent evidence have shown that overweight, including obesity, is an important     risk factor for the development of cardiovascular disease (CVD) in adults. Several studies     have found an association between overweight in childhood and increased risk of morbidity and     mortality later in life. The prevalence of overweight in children and adolescents has     increased in recent years, and consequently it is important to identify effective approaches     in the prevention and treatment of overweight in young individuals.      Approaches such as resident weight loss camps have shown promising results. A residential     camp setting provides an opportunity to increase and control exposure to, for instance,     particular foodstuffs, beverages and physical activity opportunities. However, well-designed     studies with sufficient participants are still needed on the reversal of overweight in     childhood with increased focus on documenting predictors of behavior changes associated with     decreases in overweight.      This study is carried through as a randomized controlled trial which investigates the effect     of participating in a 6 week health promoting resident for overweight fifth grade children     camp followed by 42 weeks of family support.      The study hypothesis is that participating in a 6 week resident camp and a following period     of 42 weeks of child and family support will induce a reduction in body mass index (BMI). In     addition it is expected that the intensity and duration intervention program is sufficient to     cause changes in physiological parameters related to a reduced risk of lifestyle diseases.   "
130710|NCT01574326|"     Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to        -  Evaluate the safety and tolerability of sevelamer carbonate        -  Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus   "
130711|NCT01574313|"     Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for     years. However, objective evidence of the effect of SGB was still lack. The investigators     conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of     electrocochleography (ECoG).   "
130712|NCT01574300|"     The purpose of this study is to facilitate application of the known biomarkers to patients     presenting today, and to establish a collection of biospecimens that will be useful for     discovering and validating new biomarkers for future use.   "
130721|NCT01574183|"     Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated     pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of     vilazodone for reducing marijuana use in marijuana-dependent adults. A contingency management     intervention (CM)and motivational enhancement therapy (MET)will be incorporated to encourage     study engagement and retention, and genomic DNA will be extracted to characterize subjects     according to polymorphisms of genes potentially relevant to the activity of vilazodone. It is     hypothesized that vilazodone combined with MET and CM will reduce the percent of     marijuana-positive urine drug screen results in marijuana-dependent individuals as compared     to a placebo treatment combined with MET and CM.   "
130882|NCT01571869|"     The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at     different moments of the day in lowering blood cholesterol of hypercholesterolemic.   "
130713|NCT01574287|"     Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a     small growth called an adenoma in the parathyroid glands) is an increasingly significant     medical and public health condition.      Surgery is the only effective management for primary hyperparathyroidism. However; it is     sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often     fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative     parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even     greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of     tumors.      SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing     the tumor. This, however, is a challenge because the parathyroid glands usually are located     close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and     parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the     parathyroid but not in the thyroid.      A more sensitive and specific radiotracer/tracking agent would markedly improve the     investigators ability to identify parathyroid tumors preoperatively, and thus offer more     patients a minimally invasive parathyroidectomy.      anti-3-[18F]FACBC is an amino acid based PET radiotracer which has shown utility in detecting     a variety of tumors. In cell culture experiments, anti-3-[18F]FACBC has shown uptake in     parathyroid cells greater than thyroid cells. Therefore, the investigators think that this     radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.      The primary aim of this study is to determine if anti-3-[18F]FACBC PET-CT demonstrates uptake     within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will     undergo PET-CT using anti-3-[18F]FACBC in addition to the standard 99mTc sestamibi scanning     and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced     CT scanning. Since all these patients undergo surgery routinely, the investigators will then     compare findings at surgery to those of the anti-3-[18F]FACBC PET-CT to determine if this     radiotracer is worthy of further study in a more comprehensive experiment.   "
130714|NCT01574274|"     This study is being conducted to learn about the effects of SC-PEG, which is a new form of a     chemotherapy drug called asparaginase. Asparaginase is used to treat ALL and lymphoblastic     lymphoma. The standard form of asparaginase, called Elspar, is given in the muscle once a     week for 30 weeks. There are other forms of asparaginase. The investigators will be studying     two of these: Oncaspar and Calaspargase Pegol (SC-PEG). The investigators have previously     studied giving Oncaspar in the vein (instead of the muscle) every 2 weeks in patients with     ALL, and have shown that this dosing did not lead to any more side effects than Elspar given     weekly in the muscle. The study drug, SC-PEG, is very similar but not identical to Oncaspar.     SC-PEG has been given in the vein to children and adolescents with ALL as part of other     research studies, and it appears to last longer in the blood after a dose than Oncaspar. It     has not yet been approved by the FDA. The goal of this research study is to learn whether the     side effects and drug levels of SC-PEG given in the vein every 3 weeks are similar to     Oncaspar given into the vein about every 2 weeks.      The study will also help to determine whether changing treatment for children and adolescents     with ALL with high levels of minimal residual disease may improve cure rates. Measuring     minimal disease (MRD) is a laboratory test that finds low levels of leukemia cells that the     investigators cannot see under the microscope. In the past, it has been shown that children     and adolescents with ALL with high levels of MRD after one month of treatment are less likely     to be cured than those with low levels of MRD. Therefore, on the study, the bone marrow and     blood at the end of the first month of treatment will be measured in participants with     leukemia, and changes in therapy will be implemented based on this measurement. It is not     known for sure that changing treatment will improve cure rates. MRD levels can only be     measured if the marrow is filled with cancer cells at the time of diagnosis. Therefore, MRD     studies will only be done in children and adolescents with ALL and not in those with     lymphoblastic lymphoma.      Another part of the study is to determine whether giving antibiotics during the first month     of treatment even to participants without fever will prevent serious infections in the blood     and other parts of the body. About 25% of children and adolescents with ALL and lymphoblastic     lymphoma who receive standard treatment develop a serious blood infection from a bacteria     during the first month of treatment. Typically, antibiotics (medicines that fight bacteria)     are given by vein only after a child with leukemia or lymphoma develops a fever or have other     signs of infection. In this study, antibiotics will be given by mouth or in the vein to all     participants during the first month of treatment, whether or not they develop fever.      Another goal of the study to learn how vitamin D levels relate to bone problems (such as     broken bones or fractures) that children and adolescents with ALL and lymphoblastic lymphoma     experience while on treatment. Some of the chemotherapy drugs used to treat ALL and     lymphoblastic lymphoma can make bones weaker, which make fractures more likely. Vitamin D is     a natural substance from food and sunlight that can help keep bones strong. The investigators     will study how often participants have low levels of vitamin D while receiving chemotherapy,     and, for those with low levels, whether giving vitamin D supplements will increase those     levels.      Another focus of the study is to learn more about the biology of ALL and lymphoblastic     lymphoma by doing research on blood, bone and spinal fluid bone marrow samples. The goal of     this research is to improve treatment for children with leukemia in the future.   "
130715|NCT01574261|"     Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim     of the study was to evaluate long-term effects of inositol on some cardiovascular risk     factors in PCOS patients.   "
130716|NCT01574248|"     Individuals with heart disease or high blood pressure are often prescribed angiotensin     converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors     can be associated with angioedema, a rare but life-threatening condition that causes swelling     of the face and other body parts. This study will evaluate the effectiveness of the drug     HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the     condition.   "
130717|NCT01574235|"     The main aim of the study is to assess the safety of Nivestim® treatment in patients treated     with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant     hemopathy.   "
130718|NCT01574222|"     The purpose of this study is to determine the dose that the vaccine can be given safely to     patients when injected directly into the lung tumor, without any serious side effects.   "
130731|NCT01574053|"     Enroll-HD is a longitudinal, observational, multinational study that will integrate two     existing Huntington's Disease (HD) registries, REGISTRY in Europe and COHORT in North America     and Australia, while also expanding to include sites in Latin America and Asia. With no end     date and annual assessments, the goal of Enroll-HD is to build a large and rich database of     longitudinal clinical information and biospecimens. This database will serve as a basis for     future studies aimed at developing tools and biomarkers for progression and prognosis,     identifying clinically relevant phenotypic characteristics, and establishing clearly defined     endpoints for interventional studies.   "
133763|NCT01534065|"     The purpose of this multi-center post marketing surveillance study is to monitor the safety     and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the     L1 - S1 spinal disc.   "
130719|NCT01574209|"     It is well known that the intestinal barrier is altered in celiac disease (CD), an autoimmune     disease that develops in genetically predisposed subjects exposed to ingestion of wheat     gliadin and of related prolamines of barley and rye. More recently, defective epithelial     barrier has been implicated in the pathogenesis of other conditions such as irritable bowel     syndrome (IBS). At present IBS is still considered a functional condition although low-grade     inflammation has been associated with its manifestation, particularly that following     infection. Different substances have been implicated in the (dis)regulation of intestinal     barrier, among them zonulin seems to play a key role. Other gastrointestinal peptides are     GPL-2, Ghrelin, and Epidermal growth factor (EGF). In order to shed light on the hormonal     regulation of intestinal barrier function in celiac patients before undergoing a gluten free     diet and possible differences with those of IBS patients, in the present study the     investigators will apply the non-invasive lactulose/mannitol permeability test toward the     evaluation of intestinal damage. The pattern of intestinal permeability and the GI peptides     concentration will be compared in celiac patients, IBS patients and healthy controls.   "
130720|NCT01574196|"     The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en Oncologie     des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne) coordinated by     Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at re-examining,     in their initial treatment center, all patients (a cohort of 495 patients alive in 2011),     diagnosed between 1987 and 1992, and cured of childhood cancer (except leukemia) in the     Rhône-Alpes and Auvergne regions.      The rationale for this study is based on the observation that although the survival rate of     childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are     high and greatly increase the risk of mortality in later years (estimated to be 14% in the     literature).      The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the     activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor     of cardiovascular morbidity to the individual.   "
130781|NCT01573182|"     The purpose of this study is to determine whether vaccination of stem cell donors with     Zostavax can reduce the rate of Herpes Zoster reactivations in transplant recipients.      The clinical hypotheses is: 1) that Zostavax given to stem cell donors will induce protective     VZV specific T cell proliferation in allogeneic stem cell transplant recipients that can be     transferred to recipients; 2) and that donor vaccination with Zostavax is safe for transplant     recipients as measured by viral load measurement by polymerase chain reaction assay (PCR) at     the time of stem cell donation.   "
130722|NCT01574170|"     This is a biomedical study of interventional type. The trial will include 270 patients (180     patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2     years of follow up.      This prospective study will be conduct in patients who will receive a third line chemotherapy     for metastatic breast cancer.      The main objective of the study (first cohort) is to identify patients who benefit from a     third line treatment in terms of overall survival with a score established from clinical,     histological, but also biological classic and innovative (account of circulating tumor     cells) criteria, all of these criteria must be measurable before the introduction of the 3rd     line.      This score will then be validated on the 2nd cohort.      There will be no interruption of inclusions between first and second cohort of patients   "
130723|NCT01574157|"     The purpose of this study is to see if treatment with sodium bicarbonate will lower urine     levels of proteins that are indicators of kidney damage in people with diabetes who also have     chronic kidney disease.   "
130724|NCT01574144|"     The purpose of this observational study is to collect and characterize multiple physiologic     data from a broad subset of subjects with acute heart failure (HF)      Changes in physiologic data are expected to correlate with 30-day readmission rates in this     population   "
130725|NCT01574131|"     The purpose of this study is to learn the following: whether long-term treatment (6 months)     with fenofibrate will decrease burn related sugar and fat increased in the blood and help     prevent muscle loss and improve wound healing.   "
130726|NCT01574118|"     This study is investigating a new brief psychotherapy for post-traumatic stress disorder     (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components     and modifying several others. The goal of the study is to determine whether this experimental     treatment outperforms the well-established standard treatment.   "
130727|NCT01574105|"     Blood is anticoagulated using a drug named heparin during open-heart surgery to allow it to     safely pass through the heart-lung machine which pumps the blood throughout the body during     the surgery. Each patient is given the heparin they need for their surgery. This means some     patients receive more or less heparin than other patients. In this study, the investigators     will be evaluating the current anticoagulation protocol for open heart surgery in use at the     Royal University Hospital. The goal of this project is to compare patients who require and     receive more heparin for proper anticoagulation to those patients who require and receive     less heparin.      Open-heart surgery will proceed according to the standard hospital protocol. All research     participants will be treated according to standard post-open heart surgery protocol in the     ICU. This will include measurement of blood loss by keeping track of chest tube outputs and     administration of blood transfusions.      This study focuses on Saskatoon Health Region patients having open heart surgery in terms of     the protocol for anticoagulation and blood transfusions.   "
130728|NCT01574092|"     Tumours of the brain and of the central nervous system (CNS) are the most common solid     tumours in children. Amongst these, gliomas are the most frequent, although this term covers     different histological subtypes, the most frequent being astrocytoma. However, they are rare     diseases of low prevalence.      The interest in the cisplatin/irinotecan combination in brain tumours motivated a previous     pilot study at our hospital, with encouraging results. This experience, together with the     need for new strategies for high-risk pediatric gliomas has motivated the conduct of this     study.   "
130729|NCT01574079|"     Mirror therapy may be an effective intervention in increasing motor control and gait     performance in patients with stroke.   "
130730|NCT01574066|"     Primary objective : to estimate impact of CT-scan on diagnostic for emergency department (ED)     patients with suspected Community-acquired Pneumonia (CAP).      Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and     site of care for ED patients with suspected CAP.   "
130732|NCT01573832|"     This study will use a randomized control trial design to compare wound care clients who     receive integrated care versus usual care in Community Care Access Centres (CCAC) in     Ontario. Data will be collected by existing administrative databases and linked by the     Institute for Clinical Evaluative Sciences (ICES). The researchers will analyze these     databases and report findings.   "
130733|NCT01573819|"     The study drug, GSK356278, is a possible new medicine for the treatment of Huntington's     disease. Huntington's disease, which is often called HD, is caused by a faulty gene that is     passed down through families. HD causes damage to nerve cells in the brain which causes them     to waste away. As the damage progresses patients develop symptoms that affect every aspect of     life. HD reduces people's ability to walk, talk, think, communicate and causes uncontrolled     movements. GSK356278 may slow down the progression of damage to nerve cells in people with HD     and help with their ability to think.      GSK356278 was well tolerated when it was given as a single dose to healthy people. In this     study we want to see what effects, both good and bad, GSK356278 has in people when it is     taken every day. During the study we will look at about 3 different doses of GSK356278 in     about 36 healthy people. The study will also look at how GSK356278 tablets behave in the body     after it is swallowed (this is called pharmacokinetics). The study will also look at effects     of GSK356278 on the body (this is called pharmacodynamics). The study will help to design     future clinical studies with GSK356278.   "
130793|NCT01573026|"     The purpose of this research study is to document the use if the Keystone Dental Genesis     Dental Implant System in standard clinical use and to provide 5 year survival data.   "
130883|NCT01571856|"     The purpose of this study is to determine the effect of zinc in acute watery diarrhea in     children. The investigators will evaluate the effect of product versus placebo.   "
142593|NCT01418053|"     The purpose of this study is to determine whether a daily use of a Kneipp hot cataplasm with     caraway oil is effective in the treatment of abdominal pain and complaints caused by     Irritable bowel syndrome.   "
130734|NCT01573806|"     Pharmacology of Exenatide in Pediatric Sepsis, PEPS is a phase 1-2 research study that will     examine drug safety, drug metabolism, drug action and preliminary drug clinical effects of     four does of exenatide injected every 12 hours to children with shock from infection (septic     shock). The investigators hypothesize that exenatide can be safely dosed to children with     sepsis to achieve blood levels of drug similar to that achieved in teenagers with type 2     diabetes. The investigators further hypothesize that injection of exenatide to children with     septic shock will normalize blood glucose levels and decrease levels of inflammation proteins     in the blood during the early course of sepsis.   "
130735|NCT01573793|"     The purpose of this study is to determine if providing parenting education materials     delivered in different ways during the first 30 months of a child's life will increase     child-parent attachment and promote mother-child interaction, if certain types of strategies     improve cognitive, language, and emotional development in infants and toddlers, and if our     way of delivering these materials is cost-effective.   "
130736|NCT01573780|"     The purpose of this study is to determine the dose of smac mimetic TL32711 that is safe and     tolerated when given with gemcitabine hydrochloride to patients with advanced cancer   "
130737|NCT01573767|"     This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group,     placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma.     Subjects entering the run-in period will stop their current asthma medication and be given     open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and     salbutamol/albuterol as required to use throughout the run-in and double-blind treatment     period. At Visit 3 subjects meeting the randomization eligibility criteria will receive     vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI)     once daily for 4 weeks in addition to open-label fluticasone propionate twice daily     throughout the treatment period. Primary endpoints consist of change from baseline in clinic     visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period     in all subjects. Safety assessments include adverse events, oropharyngeal examinations,     clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all     subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at     specific time intervals relative to the dose of study drug.   "
130738|NCT01573754|"     Porphyria cutanea tarda (PCT) is an iron-related disorder that responds to treatment by     phlebotomy or low-dose hydroxychloroquine, but comparative data on these treatments are     limited. The hypothesis is that hydroxychloroquine is noninferior to phlebotomy in terms of     time to remission. Patients with well documented PCT are assigned to treatment by     randomization if specific criteria are met. All patients are followed until remission -     defined as achieving a normal plasma porphyrin concentration.   "
130739|NCT01573741|"     Primary Outcome Measures:      Evaluate the changes in neuroimaging and biochemistry measures with ketamine treatment.      Secondary Outcome Measures:      Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in     psychiatric symptoms, and suicidal ideation.   "
130740|NCT01573728|"     The pilot project proposed here will establish the feasibility and preliminary data necessary     to test in a subsequent randomized trial: 1) whether independent of social contact, aerobic     exercise training is effective in the treatment of depression and 2) whether changes in     biological markers indicate an anti-inflammatory process, neurogenesis process, or both as a     result of exercise. Target participants are adults aged 46 years or over who have current     minor to moderate depressive symptoms.      This pilot is a three-arm design of low dose exercise versus public health dose exercise     intended to: 1) establish the feasibility, acceptance, and safety of Internet-based     supervised exercise training and 2) obtain retention and attendance estimates needed to     determine sample sizes for the follow-up trial.   "
130751|NCT01573585|"     The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping     Training) exercises will improve walking balance in individuals after stroke to a greater     extent than usual care.      Hypothesis: The primary hypothesis is that improvements in walking balance will be larger     following 12 sessions of FAST exercise retraining compared to usual care in persons in the     sub-acute phase after stroke.   "
130914|NCT01571453|"     This study will be conducted with the aim of investigating the efficacy, safety and     tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active     comparator (venlafaxine extended release 150 mg/day).   "
130741|NCT01573715|"     Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical     ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a     prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular     blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al.     ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve     survival remain speculative. They are as follows:        -  reduction of the consumption of oxygen linked to ventilatory workload;        -  increase of chest wall compliance improving mechanical ventilation during ARDS and          better adaptation to the protective ventilation strategy;        -  anti-inﬂammatory effect contributing to a reduction in pulmonary inﬂammation and          improvement in oxygenation,        -  reduction of the variations of transpulmonary pressure (TPP) by the way of better          synchronisation between patient and the ventilator.      The use of NMBA could also reduce the ventilator induced lung injury by a better control of     TPP.   "
130742|NCT01573702|"     - Progression free survival after locally ablative therapy and erlotinib in EGFR patients     progressed after EGFR-TKI therapy   "
130743|NCT01573689|"     The methodology of this clinical trial is based on the realisation of a group intervention     with children who lost a parent. Interviews preintervention and postintervention with     participants will be done as well. The purpose of this study is to answer the following     question: What are the benefits for children who are in the process of bereaving a parent to     participate in a group work intervention based on the mutual aid model ?. The aim of the     research is to explore the benefits for grieving children to participate in an group work     intervention based on the mutual aid model. To do so, the research has three distinct     objectives : 1) to develop and apply a program of group work interventions for grieving     children based on the mutual aid model ; 2) to explore the extent to which participation in     the group facilitates changes in the children's discourse about death and the loss of their     parents, and 3) to examine, from the children's own perceptive, the possible impact that     their participation in the group have on their experience of bereavement.   "
130802|NCT01572909|"     The purpose of this research study is to assess the effectiveness, safety and tolerability of     an investigational drug, called Bendavia, on reducing the area of heart muscle affected by a     myocardial infarction (heart attack) in participants who have undergone successful coronary     intervention (heart treatment) and stenting.      Participation in the study is due to last for approximately 7 months. It is planned that up     to 300 participants will take part in the study from centers in the United States and around     the world.   "
142594|NCT01418040|"     This is a single centre prospective observational noninterventional study of men with     histological confirmed prostate cancer, high risk disease and not positive for metastatic     disease planned to receive Radiotherapy and 18 months of Androgen Deprivation Therapy (ADT).     Although ADT improves the chance of cure, it can also have many side effects. One of these is     bone mineral density loss. When this is advanced, it is called osteoporosis. Men with     osteoporosis have a higher chance of getting fractures of bones such as the hip and spine.     Currently, the best way to measure for osteoporosis is to do a bone mineral density scan     using a DEXA scanner.      The primary objective of this study is to see if baseline Magnetic Resonance Imager (MRI) and     a Computer Tomogram (CT) combined with clinical factors predicts which men are at greater     risk of accelerated ADT induced bone mineral density loss than baseline DEXA scanning alone.     The data from the patients will be used to construct a model predicting annual rate of bone     loss based on baseline imaging, clinical and biochemical characteristics.      Secondary aims for this study are as follows:        -  Evaluating the feasibility, toxicity (acute and late) and efficacy (5 year biochemical          control by the Phoenix definition)of multimodality therapy with hypofractionated          radiotherapy (giving a larger dose of radiotherapy over a shorter time 5½ weeks compared          with a standard 8 week approach). Although used overseas, this 5½ week regimen has not          been used widely in Australia, and we would like to see if we gain similar results here          as have been reported from the US.        -  Feasibility and efficacy of a risk adapted duration of neoadjuvant hormonal therapy.          Usually, ADT is given for between 19 months before radiotherapy is started but there is          no agreement as to which duration is best. This trial aims to tailor the duration of ADT          prior to radiotherapy based on blood PSA test results.        -  Prognostic value of circulating tumour cells (CTCs). This is a blood test which can          detect cancer cells in the blood which has been used for patients with metastatic          cancer. The presence of CTCs in men with prostate cancer correlated with poorer overall          survival. Potentially, high risk prostate cancer patients with CTCs detected may          represent a very high risk group and could therefore warrant treatment intensification.        -  To correlate bone marrow changes on MRI with changes in blood counts and patient          reported fatigue. Measuring bone marrow may help in predicting not just which patients          are at risk of losing bone faster but also of becoming anaemic, and suffering fatigue. A          correlation may better explain some of the toxicities associated with ADT.        -  Implementation of a nomogram based radiotherapy target delineation algorithm. This trial          aims to use a decision making tool called a nomogram to help tailor the area to treat in          a more standard way.   "
130744|NCT01573676|"     Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep     breathing disorders in patients with extreme BMI.      Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The     characteristics of patients with sleep apnea that were evaluated for bariatric surgery and     had a full overnight polysomnography (PSG) screening for OSA were described and it was found     that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of     pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.      The investigators would like to demonstrate the impact of bariatric surgery on OSA as a     function of time.   "
130745|NCT01573663|"     The purpose of this study is to evaluate the drug-durg interaction between ambroxol and     levodropropizine.   "
130746|NCT01573650|"     1. To analyse the outcome of different treatment options of peripheral nerve repair with no          gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize          peripheral nerve repair        2. To reduce morbidity with the same outcome   "
130747|NCT01573637|"     The efficacy of raloxifene versus placebo was compared over a six-month period, as an     adjuvant treatment of the negative symptoms of schizophrenia in a group of 80 post-menopausal     women. The aim of the study is to analyze whether raloxifene has an effect on the positive     and negative symptoms of schizophrenia, and on psychopathological symptoms in general, and on     social and neuropsychological functioning, and to study the influence of genetic     polymorphisms in treatment response.   "
130748|NCT01573624|"     Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in     combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled     Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.      Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic     bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms     on large and small airways. Most of the experience with older anti-cholinergics had been with     acute use and little is known about their effect in chronic use in asthma. This is a     multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled     GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and     Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each     eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3     treatment periods per subject. The total duration of subject participation is approximately     14 weeks.   "
130749|NCT01573611|"     Constituents of grapes have been studied for their antioxidant, anti-inflammatory, and     anticarcinogenic properties. In the past decade, there has been emerging evidence regarding a     potential role for grapes in slowing cognitive decline and other effects of aging.     Furthermore, evidence has been obtained in vivo that supplementation of aged rats with grape     seed extract improves cognitive performance. Despite the promising accumulating data     supporting the use of grapes as a safe and effective strategy for delaying the incidence of     dementia, it remains unclear how grape intake would be useful with respect to factors such as     dose schedule or stage of dementing illness. In general, well-controlled experimental data     obtained in human subjects is in need of much further development. The investigators aim to     measure effects of grape intake on cerebral metabolism and cognitive function, and to     determine whether initial patterns, and magnitude of change, of cerebral metabolism assessed     by positron emission tomography (PET) can serve respectively as a predictor of, and biomarker     for, the magnitude of cognitive changes resulting from intake of grapes.   "
130750|NCT01573598|"     Safety and Efficacy of Vilazodone in Major Depressive Disorder   "
130915|NCT01571440|"     The purpose of this study was to determine the effect of soluble corn fiber on calcium     absorption and retention and gut microflora in adolescent boys and girls.   "
130752|NCT01573572|"     Due to the lack of information generated in the pivotal phase III trials assessing potential     effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal     endothelium, the FDA requested clinical information from a 1-year (minimum) clinical study to     support that there are no adverse effects on the corneal endothelium following intravitreal     injections of Macugen.   "
130753|NCT01573559|"     This study serves as a comparison study between the EPIC ClearView and a predicate device.   "
130754|NCT01573546|"     ENLIGHTEN will examine the effects of exercise, the dietary approaches to stop hypertension     diet (DASH), and a combined exercise and DASH intervention on cognitive function among adults     with cardiovascular disease (CVD) risk and cognitive deficits. Participants will be     randomized to one of the three treatments, or a health education control condition, for 6     months, and will complete assessments of CVD health and cognitive function before and after     treatment.   "
130755|NCT01573533|"     The purpose of this study is to determine whether Rituximab therapy is safe and effective in     treating patients with the kidney condition, focal segmental glomerulosclerosis (FSGS), that     is no longer responsive to traditional therapies.   "
130756|NCT01573520|"     Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients     is cumbersome, partly due to patient's non-adherence to prescribed drugs.      The main objective of this study was to assess whether an integrated care (IC) approach, in     which adherence data are integrated in the decisional process, led to improved therapeutic     control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as     compared to a usual care (UC) approach, in which biological values represent the main stem of     the decisional process.      The predefined hypothesis was that patients of the IC group should reach the iPTH targets     using 25% less doses of cinacalcet at 6 months than those of the UC group.   "
130803|NCT01572896|"     The purpose of this study is to demonstrate the effectiveness of the Taking Charge: Managing     JIA Online Internet intervention, when compared with an attention (static education only     websites) control group in improving pain and HRQL as well as other health outcomes (anxiety,     depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents     with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10     pediatric rheumatology hospital clinics in the Canada to either the experimental or control     groups.   "
130757|NCT01573507|"     Background: Although glucose is essential to cerebral function, abundant experimental and     clinical evidence demonstrates that endogenously released lactate, rather than glucose, is     the preferential energy substrate for the brain in conditions of stress and acute injury. In     patients with severe Traumatic Brain Injury (TBI) and aneurysmal subarachnoid hemorrhage     (SAH) monitored with cerebral microdialysis and brain tissue oxygen (PbtO2), our preliminary     data show that increased brain extracellular lactate is frequently observed. Our findings     indicate that elevated brain lactate more often occurs in the absence of brain     hypoxia/ischemia and is mainly the consequence of increased cerebral glycolysis, i.e. it     occurs in association with high extracellular pyruvate. These data suggest that the primary     source of elevated lactate is activated glycolysis and strongly support the concept that     endogenously released lactate can be utilized by the injured human brain as energy substrate.     They prompt further investigation to examine whether exogenous lactate supplementation can be     a valuable neuroprotective strategy after TBI or SAH. Indeed, in animal models of brain     injury, administration of exogenous lactate improves neuronal and cognitive recovery.      Hypothesis: The investigators test the hypothesis that lactate therapy, administered during     the acute phase of TBI or SAH, might exercise neuroprotective actions by restoring brain     energetics and improving brain tissue PO2 and cerebral blood flow (CBF).      Aim of the study: The aim of this single-center study is to examine the effect of sodium     lactate infusion on cerebral extracellular metabolites, brain tissue PO2 and cerebral blood     flow, measured with CT perfusion and transcranial doppler (TCD).      Design: Prospective phase II interventional study examining the effect of a continuous 3-6     hours infusion of sodium lactate (20-40 µmol/kg/min), administered within 48 hours from TBI     or SAH, on cerebral extracellular glucose, pyruvate, glutamate, glycerol, PbtO2 and CBF.   "
130758|NCT01573494|"     Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as     a prognostic factor and predictor of therapeutic response. The detection of CTC by     immunomagnetic method has proved its reliability and its usefulness for monitoring breast     cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch,     Veridex LLC) was approved by the FDA in these indications. However, to date there is no     reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA     by reverse specific melanoma is disappointing. Recently, a new detection system of CMC     immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the     advantage of combining immunomagnetic selection step and a step of identifying by     immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown     encouraging results. The investigators propose a prospective study of the CellSearch system     in patients with melanoma.      Primary objective: To determine the effect of treatment on the number of circulating melanoma     cells in patients with metastatic melanoma.      Secondary objectives:        -  determine the percentage of patients with metastatic melanoma with melanoma cells          circulating        -  seek a relationship between the number of circulating melanoma cells and prognosis in          patients with metastatic melanoma        -  seek a relationship between the change in the number of circulating melanoma cells          before / after treatment and tumor response in patients with metastatic melanoma   "
130759|NCT01573481|"     The purpose of the study is to compare pressure controlled continuous mandatory ventilation     versus pressure support ventilation during the night for weaning to mechanical ventilation in     chronic obstructive pulmonary disease patients and their impact onto sleep quality.   "
130760|NCT01573468|"     This study is being performed to evaluate the efficacy and safety of capecitabine in     combination with tesetaxel versus capecitabine in combination with placebo as second-line     treatment for patients with gastric cancer.   "
130761|NCT01573442|"     This randomized phase III trial studies testosterone to see how well it works compared to     placebo in treating postmenopausal patients with arthralgia (joint pain) caused by     anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia     associated with the use of aromatase inhibitors, such as anastrozole or letrozole.   "
130797|NCT01572974|"     To Compare the overall quality of life of patients with no Barrett's esophagus ,     non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia     (LGD), and Barrett's esophagus with high grade dysplasia (HGD). We also Compare the overall     quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease     (GERD) symptoms to those with no GERD symptoms   "
131175|NCT01568047|"     The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at     steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated     with levodopa/dopa-decarboxylase inhibitor.   "
130762|NCT01573429|"     Background:      - Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and     thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and     water from plastic products, including water and baby bottles. However, not all of the risks     of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the     body gets rid of BPA.      Objectives:      - To study controlled exposure to BPA and its effects on the body.      Eligibility:      - Healthy, non-obese volunteers between 25 and 45 years of age.      Design:        -  Participants will have six visits over about 2 to 4 weeks for this study.        -  At the first visit, participants will be screened with a physical exam and blood and          urine tests. They will complete a questionnaire about exposure to BPA-containing          products. They will also receive a list of medications that should not be taken during          the study period.        -  The second visit will last about 13 hours. Participants will fast for 8 hours before the          visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier          to study in the body). Regular blood samples will be taken over the 13-hour visit. All          urine will also be collected. Participants will receive breakfast and lunch during the          visit.        -  Participants will have four follow-up visits. They will collect and store all of their          urine between each follow-up visit. Blood samples will be collected at the follow-up          visits.   "
130763|NCT01573416|"     Alcohol and drugs consumption are among the highest risk factor for health in Chile and     abroad. In Chile, harmful use of alcohol continues to be a major contributor to the burden of     disease while lost years of healthy life are higher than many other risk factors such as     hypertension, overweight and obesity, and hyperglycemia. It is important to say that the     impact of alcohol consumption is greater in younger age groups where fatal injuries occur     relatively early in life, as well.      In Chile, the consumption pattern in 2008 showed that 49.8 % consumed at least once in the     last month for alcohol, 3.5 % for marihuana and 1.3 % for cocaine. This prevalence was even     greater in young adults and adolescents and is associated with other mental health issues and     poorer life quality. Those who have consumed marihuana during the last year, 25% report     dependence symptoms. For cocaine derives, dependency rises up to 50% among the consumers.     This data reinforce the need to design and implement strategies for reducing alcohol and     drugs consumption in our population.      Also, it is well known that a high number of those who suffers from any addiction problem do     not get attention in a specialized center. The are many barriers to do so, such as lack of     motivation, lack of resources, social problems, access to care problems, and so on.      Chile has a shortage of preventive interventions for those at risk to develop an addiction at     an early stage of substance use because front line health services (Primary health care and     emergency care) and other social services (police stations, local justice courts) do not have     a screening system and a model of brief intervention.      The Pontificia Universidad Catolica de Chile, through its Addiction Studies Center (CEDA UC)     and its Department of Family Medicine, is working in conjunction with SENDA (Servicio     Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol ) to design,     implement and evaluate a communal system for early detection, brief intervention and referral     to treatment (SBIRT), in people older than 18 years, with substance consumption in five     municipalities in the country.      The aid of this study is to demonstrate that a model of brief intervention is more effective     than the approach currently used in patients with substance use at moderate risk     (i.e.follow-up). It is a multicentric randomized controlled trial, single blind, with a group     to receive brief intervention and a control group that is kept in control and waiting list     being re-evaluated three months later.      The target population is composed by users whose ASSIST screening scores place them in the     moderate risk group, for which there has not been defined a structured intervention yet by     our health system. The information will be obtained from the scores obtained after the     application of the ASSIST-WHO questionnaire.   "
130764|NCT01573403|"     This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical     study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as     well as its safety in healthy volunteers.      DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is     hypothetically more potential than PPIs in suppressing gastric acid as our previous     preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+     ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It     is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.   "
130765|NCT01573390|"     1. Quantitative validation of non-contact oxygenation imaging by the CWC imaging system        2. Quantitative validation of non-contact vascular function imaging by the CWC imaging          system        3. Evaluation of the clinical usability of the CWC imaging system for further technology          development and engineering improvement   "
130804|NCT01572883|"     The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab     (patients treated for early breast cancer) is really safe for the heart even years after     treatment and if the investigators should use these two treatments concomitantly without     additional harm.   "
130884|NCT01571843|"     The purpose of the study is to determine the effect of forearm exercise on forearm bone     density in post-menopausal women with or without primary hyperparathyroidism.      The investigators hypothesize that forearm exercise will increase forearm bone density in     patients with primary hyperparathyroidism more so than in patients without primary     hyperparathyroidism.   "
130766|NCT01573377|"     Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in     reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed     menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might     become the patients with impaired glucose tolerance or type 2 diabetes. It has been confirmed     that insulin resistance (IR) is a common feature in PCOS and adipokines might play roles in     the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects on     carbohydrate and lipid metabolism.      The present clinical trial intends to compare the effects of metformin and oral     contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and     menstrual cycle etc. The investigators also aim to study the effects of metformin on serum     adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS     patients.   "
130767|NCT01573364|"     The aim of this observational study is to evaluate the pulmonary hyperinflation and its     immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent     asthmatic patients with dyspnea.   "
130768|NCT01573351|"     The purpose of this study is to assess efficacy, as determined by the proportion of subjects     with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C     virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.   "
130769|NCT01573338|"     This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin     / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated.     Every patient will receive drug treatment, there is no placebo group. Different groups of     patients will receive different dosages of BAY1000394 to determine the safety and maximum     tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy     is the standard dose usually administered and will not change.      The study will also assess how the drug is metabolized by the body and changes in tumor size.      BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will     stop if the tumor continues to grow, if side effects occur which the patient can not tolerate     or if the patients decides to exit treatment.   "
130770|NCT01573325|"     The purpose of this study is to describe the HRQoL in those with MELD scores </= 15 in a     single center for those who are pre-liver transplant candidates   "
130771|NCT01573312|"     This is a single center, randomized, double-blinded, controlled, Phase I, small targeted     prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old,     inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an     intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005)     virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or     without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses     administered 28 days apart. This study will use a systems biology approach to assess the     human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first     vaccination. The systems data will be integrated with immunogenicity and reactogenicity data     to develop a systems model of the human immune response to A/H5N1 vaccine with or without     AS03 adjuvant.   "
130832|NCT01572519|"     The purpose of this study is to determine the safety, pharmacokinetics, and preliminary     efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin     lymphoma.   "
130772|NCT01573299|"     Even if it is a daily questioning for the stroke physician, no concrete recommendation exists     regarding the time-point of the mobilization of stroke patients. In this study, we will     compare two mobilisation strategies: early versus delayed verticalisation. 400 ischemic     stroke patients will be included in this prospective randomized controlled trial, equally     distributed in two groups. In the early mobilisation procedure the patient is allowed to go     and sit outside of the bed the day after the stroke onset, whereas in the other arm, this     procedure is delayed to the third day after stroke onset. The outcome in both groups will be     assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to     investigate the functional outcome of the patients.   "
130773|NCT01573286|"     This protocol outlines a randomized,open label trial examining the safety, pharmacology and     efficacy of Glucagon like peptide 2 (GLP-2) in infants and children with intestinal failure.     The investigators hypothesize that GLP-2 given subcutaneously in these patients will be well     tolerated, and have similar metabolism to what has been shown in adults. The investigators     also expect to show an improvement in the tolerance of enteral nutrition, and a decreased     requirement for intravenous feeding.   "
130774|NCT01573273|"     Stress is likely involved in relapse to cocaine use. This project will investigate the role     oxytocin may play in the stress response in cocaine-dependent men and women and examine how     oxytocin may impact brain activity in individuals exposed to cocaine-related cues.   "
130775|NCT01573260|"     Parkinson's disease involves many motor difficulties as well as non-motor ones. Recent     research has strongly suggested that exercise is very important for Parkinson's disease. We     are interested especially in dance as a form of exercise, because it combines physical     movements with balance tasks, social engagement, and mental stimulation. Therefore, we think     dance classes may be a very beneficial exercise for Parkinson's disease; the purpose of this     study is to see if Argentinean Tango classes might improve motor and non-motor manifestations     of Parkinson's disease.   "
130776|NCT01573247|"     This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine     the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for     further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML).     The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.   "
130777|NCT01573234|"     Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best     practice clinical care in subjects with cut injuries and abrasions with particular regard to:     Wound healing (complete reepithelialization) and patient's pain.      In the context of the study will be collected secondary outcomes related to type of lesion     and its clinical evolution through the analysis of the items in the scale of the Pressure     Sore Status Tool(PSST).   "
130778|NCT01573221|"     Evaluation of the sensitivity and specificity of PMSI to identify the burden of stroke in     France,from 2500 cases   "
130779|NCT01573208|"     The goal of the study is to know if the reconstruction of the lower limb mechanical axis and     the patient knee function is improved after Total Knee Arthroplasty (TKA) using patient     specific instruments.   "
130780|NCT01573195|"     The purpose of this study is to pilot the use of best practices alerts to enhance an     antimicrobial stewardship program using the electronic medical record, EPIC.   "
130782|NCT01573169|"     Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism.     Intermittent pneumatic compression combined with elastic stockings have been shown to be     superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis     after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are     ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic     stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism     in patients with ICH because the use of anticoagulants may cause an enlargement of the     hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and     safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous     intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated     compression stockings and/or intermittent pneumatic compression and/or early mobilization)     will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke     onset.   "
130783|NCT01573156|"     Vascular Targeted Photodynamic therapy (VTP) with the Vascular Occluding Agent (VOA) WST11,     may offer an alternative, providing tumour destruction via a minimally invasive approach. In     this investigation, the investigators plan to use the WST11 VTP procedure to treat a     predetermined small renal tumour targets. Patients will be given a general anaesthetic, to     ensure immobility, and prevent discomfort during treatment sessions. Treated patients will     then undergo surgical resection of their tumours, and the accuracy and reliability of tissue     death with VTP will be assessed histologically. The aim of this proof of concept study is to     demonstrate whether this modality has potential for a clinical role in the treatment of     oncological kidney disease, either as an alternative to surgery, or where surgery is not     feasible.   "
130784|NCT01573143|"     The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether     perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial     fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing     elective cardiac surgery.   "
130785|NCT01573130|"     The purpose of the study is to investigate the effects of an internet-administered,     therapist-assisted physical exercise program for the treatment of depression.   "
130786|NCT01573117|"     Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac     arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling     associated cerebrovascular disease. The narrow-time-frame is a major issue (time is brain).     To provide immediate cooling without delay, easy to use, mobile and effective methods are     needed. Cold infusions (4 °C) are an accepted standard worldwide. The RhinoChill (BeneChill,     USA) is a new device. A comparison of these two induction methods has never been done before.     Neither was the effect of cold infusions on brain-temperature measured. For the first time     iCOOL 1 compares feasibility, safety and efficacy of the two methods.   "
131176|NCT01568034|"     The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa     pharmacokinetics when administered in combination with immediate release levodopa/carbidopa     or levodopa/benserazide in Parkinson's Disease (PD) patients.   "
130787|NCT01573104|"     The investigators have a new technique of looking at urine to see whether it contains protein     fragments that are released by damaged kidneys. These fragments seem to be more accurate than     the current blood tests that the investigators use to diagnose renal failure. This technique     needs to be validated with a group of patients that have a relatively high incidence of renal     failure, cardiopulmonary bypass.      The investigators hypothesise that using novel markers of renal dysfunction will identify     patients who go on to develop renal failure earlier, and in a higher number than the standard     blood tests.      The investigators aim to collect urine from patients before going onto bypass, and then at     Day 1 and Day 2 after bypass. This urine will be analysed for protein fragments, as well as     other new markers of renal dysfunction. The investigators will also take blood at baseline     and for the first two days in Cardiac Intensive Care, and compare the accuracy of the new     tests with the 'gold standard' that is creatinine.   "
130788|NCT01573091|"     The purpose of the study is to collect some parameters (clinical, electrical, radiographic,     echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.   "
130789|NCT01573078|"     The purpose of this study is to determine whether emotional processing and somatic     dissociation influence IBS-like symptoms in Crohn's Disease patients.   "
130790|NCT01573065|"     The purpose of this study was to determine whether a brief counseling intervention coupled     with rapid HIV testing was feasible and effective at decreasing alcohol consumption and     sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.   "
130791|NCT01573052|"     A randomized, double-blind controlled trial comparing treatment outcomes between     chloriazepide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent     veteran subjects. The objective of this trial is to compare the safety and effectiveness of     these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin     over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence,     withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and     alcohol craving.   "
130792|NCT01573039|"     CMV disease is a challenge to the success of renal transplantation. Recently, the     investigators analyzed data from 792 renal transplant recipients performed at our hospital     between 1999 and 2005. After the usual exclusions, 663 patients were analyzed. This     population showed that the incidence of CMV disease is stable and occurs in approximately     20-22% of all patients and invasive disease in approximately 5% every year. In seronegative     patients and those receiving anti-lymphocyte (AL), CMV prophylaxis, done with ganciclovir for     90 days is our routine and in the majority of transplant centers. In seropositive patients     without associated risk factors (such as the use of AL) universal prophylaxis is not done.     Rather, in this group, early diagnosis, by detection of antigenemia or viremia by     quantitative PCR, is performed in patients who show symptoms compatible with CMV disease. In     the investigators analysis the incidence of CMV disease in seropositive patients is around     16%. These patients are usually hospitalized and treated with GCV IV for 14-21 days. This     leads to an additional costs of admissions, biopsies for the diagnosis of disease invasion,     etc. Besides these costs, the survival of the grafts in the long run is lower in patients     with CMV disease than in those without CMV, particularly when associated with acute     rejection. In recent years, monitoring of viremia (PCR / antigenemia) and preemptive     treatment when it reaches substantial values, have increasingly been suggested. Patients in     whom the detection of viremia in progressive values is detected would be treated as     outpatients before the disease develops. To turn this hypothesis into reality, there is an     urgent need to define cutoff values for CMV-PCR in the detection of developing CMV disease.   "
130794|NCT01573013|"     In a cross-sectional study allotted by the ethical committee of the ETH Zurich, we are     investigating the extent of anemia, iron deficiency and lead intoxication in young children.     For this purpose an assessment of body lead burden and iron status was conducted in a cohort     of individuals residing in areas of presumed high lead exposure. Associations between lead     burden and iron status will be investigated in the near future (current status of the study).      In a follow-on intervention study, the effect of iron fortification with and without NaEDTA     on blood lead levels in lead-exposed children will be evaluated; and the relative impact of     these two strategies on child growth, motor and cognitive test performance will be compared.      This study will investigate the potential use of iron fortification to not only combat anemia     but also reduce body lead burden in lead-exposed populations; it specifically investigates     whether iron fortification with NaFeEDTA could have additional beneficial effects to iron     alone.   "
130795|NCT01573000|"     Subjects were randomized to receive either tositumomab (Anti-B1 Antibody) and iodine I 131     tositumomab (Arm A) or unlabeled tositumomab (Arm B). Subjects randomized to Arm B were     allowed to cross over and receive I 131 tositumomab once their disease had progressed as long     as they still fulfilled the protocol entry criteria (except for exclusion criterion 12, prior     monoclonal antibody therapy) and were human anti-murine antibody (HAMA) negative. Study     endpoint assessments of response were conducted by a Masked Independent Randomized     Radiographic and Oncologic Review (MIRROR) panel and the Study Investigators' assessments of     safety and survival. Subjects who completed at least two years of follow-up in Protocol     BEX104515 (formerly Corixa Protocol RIT-II-002) were enrolled in long term follow-up Protocol     BEX104526 (formerly Corixa Protocol CCBX001-051), an administrative protocol, for continued     radiographic response evaluations and safety evaluations every 6 months for years 3 through 5     post-treatment and annually for years 6 through 10 post-treatment. Subjects in BEX104526 were     assessed for survival, disease status, subsequent therapy for NHL, and long-term safety,     including the use of thyroid medication, development of hypothyroidism, human anti murine     antibody (HAMA), myelodysplastic syndrome, acute myelogenous leukemia, and all other     secondary malignancies. Additionally, subjects were followed for the development of any     adverse event(s) deemed by the Principal Investigator as being possibly or probably related     to a subject's previous treatment with Iodine I-131 tositumomab. Laboratory evaluations     consisting of a thyroid stimulating hormone level and a complete blood cell count, with a     differential and platelet count, were obtained annually through year 10 post-treatment.      Dosimetric Dose: Subjects received 450 mg of tositumomab IV followed by 5.0 mCi of Iodine     I-131 and 35 mg of tositumomab. Following the dosimetric dose, whole body dosimetry was     performed on each subject using a total body gamma camera. Whole body anterior and posterior     whole body images were obtained at the following timepoints.        1. Within one hour of infusion of the dosimetric dose and prior to urination        2. 2-4 days after infusion of the dosimetric dose, following urination        3. 6-7 days after infusion of the dosimetric dose, following urination Therapeutic Dose:          The total body residence time, derived from total body gamma camera counts obtained at          the 3 time points, was used to calculate the iodine-131 activity (mCi) to be          administered to deliver the therapeutic total body irradiation dose of 65 or 75 cGy. The          therapeutic step was administered 7-14 days after the dosimetric step and consisted of          tositumomab 450 mg followed by an activity (mCi) of iodine-131 calculated to deliver 75          cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg of          tositumomab.      For subjects with ≥150,000 platelets/mm3, the recommended dose was the activity of iodine-131     calculated to deliver 75 cGy of total body irradiation; for subjects with NCI Grade 1     thrombocytopenia (platelet counts ≥100,000 but <150,000 platelets/mm3), the recommended dose     was the activity of iodine-131 calculated to deliver 65 cGy of total body irradiation.   "
130796|NCT01572987|"     This clinical trial will evaluate a patient population with Barrett's esophagus(BE)     containing high grade dysplasia or intramucosal cancer and compare the effects of     endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise     endoscopic mucosal resection(S-EMR).   "
130798|NCT01572961|"     Current stimulation induces microvascular dilation in human skin. The investigators aimed to     study (1) whether the current vasodilation is amplified after two segmental current     stimulation as compared to one stimulation; (2) whether this amplification relies on     prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover     trial is conducted in Angers, France.   "
130799|NCT01572948|"     The purpose of the study is to propose that roflumilast is associated with meaningful     reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including     confirmation of previously described results, and correlate these findings with improvement     in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD.     The investigators aim to demonstrate this regardless of concomitant medication use, including     inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic     pathway by which these effects occur.   "
130800|NCT01572935|"     Background: Recent evidence from several countries has emerged suggesting that the increase     in the prevalence of childhood obesity has slowed down substantially, or even leveled off.     Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and girls,     respectively, were overweight or obese in Switzerland. In 2007, the prevalence of overweight     was significantly lower, with 11.3% and 9.9% of school-aged boys and girls, respectively,     being overweight or obese. Further trend analyses are necessary to confirm that the     stabilizing trend observed reflects a long-term change in the rates of childhood overweight     and obesity.      Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national     studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12     year old children in Switzerland during this 5 respectively 10 year time period. Height and     weight will be measured and used to calculate body mass index (BMI). BMI references form the     Centers for Disease Control and Prevention will be used to determine the prevalence of     underweight (< 5th percentile), overweight (≥ 85th and < 95th percentile) and obesity (≥ 95th     percentile). Waist and hip circumference will be measured. Moreover, skinfold thicknesses and     bioelectrical impedance analysis will be performed to calculate body fat percentage.   "
130801|NCT01572922|"     Iron overload is a severe complication of multiple blood transfusions. As the body has no     physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in     organs and lead to iron toxicity. Accurate assessment of iron overload is paramount to     quantify excessive iron accumulation and to monitor response to iron chelation therapy.     Magnetic resonance imaging (MRI) methods have been used to noninvasively measure hepatic iron     concentration (HIC). Although MRI-based measurements of transverse relaxation rates (R2 and     R2*) accurately predict biopsy-proven HICs below 15 mg Fe/g, previous studies have shown that     their precision is limited for HICs above 15 mg Fe/g and inaccurate above 25 mg Fe/g. Current     R2* gradient-echo (GRE) MR techniques fail occasionally for very high iron overloads (HIC ~     15-25 mg Fe/g) and always for massive iron overloads (HIC > 25 mg Fe/g) because R2* is so     high that the MR signal decays before it can be measured accurately.      Overall accrual: 235 (200 patients, 35 healthy volunteers)      Purpose: To determine if a new MRI (UTE) can measure the amount of iron in the liver of     people with large amounts of iron and compare the results with the same patient's liver bx.     Estimated patient accrual is 200. It is estimated that 41 of these patients will have     clinical indication for liver biopsy.      Volunteer purpose: To test the UTE MRI to ensure it runs correctly before testing in     patients, collect data of normal values of iron in the liver in people without iron overload     using the UTE MRI and to compare the current MRI (GRE) with the UTE. The UTE MRI will give an     accurate value of liver iron in patients with large iron deposits in the liver, therefore     providing an accurate means to diagnose, monitor, and provide treatments for participants.     This new technology will impact the care of many different populations with iron overload,     such as patients with sickle cell disease and thalassemia. Estimated accrual for healthy     volunteers is 35.   "
130805|NCT01572870|"     Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease     in CF Patients.      Aim: To evaluate the link between CHIT1 duplication in CF patients and the predisposition to     ABPA or persistent Aspergillus infection.      Patients: 40 CF patients. Design: Observational, single visit. Methods: All patients will be     assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1     duplication, immunoglobulin E (IgE) and Eosinophils levels. Part of the patients will be     assessed for RAST, skin prick test.      Primary outcome measure is the difference in CHIT1 genotyping between the groups.   "
130806|NCT01572857|"     The measurement of 24-hour proteinuria allows an assessment of treatment response in patients     with multiple myeloma. But it is difficult and restrictive to make.      This study was therefore designed to investigate the correlation between the ratio of     proteinuria / creatinine on samples, easier to obtain, and the 24-hour proteinuria in     assessing response to this treatment .   "
130807|NCT01572844|"     Dermatomyositis is an inflammatory muscle disorder that is often associated with many skin     findings. One of the skin findings seen in up to 50% of individuals with juvenile     dermatomyositis, an early onset form of this condition, and up to 20-30% of adult     dermatomyositis patients who have not responded to treatment, is calcinosis, or deposits of     calcium within the skin and muscle tissue. In addition to being cosmetically unappealing,     involvement of deeper tissues with calcinosis may lead to contractures, or shortening of     muscles, which may have a significant impact on functioning and quality of life.     Unfortunately, there is no known effective treatment of dermatomyositis associated     calcinosis. However, recent reports have shown that a medication called sodium thiosulfate     has been effective in treating individuals with calciphylaxis, a condition where calcium is     deposited within blood vessels, and with tumoral calcinosis, a genetic form of calcification,     when receiving this medication by vein. In addition, recent advances in laser technology have     led to the development of methods that may allow topical medications to penetrate deeper     layers of the skin. The investigators have designed a pilot study to evaluate the use of     topical sodium thiosulfate solution in treating superficial calcinosis in individuals with     juvenile and adult dermatomyositis. The investigators will use laser to assist in the     delivery of this medication to areas of calcinosis.   "
130808|NCT01572831|"     Patients in the ICU whose infection is resolving will be randomized to standard duration of     antibiotics compared to duration determined by a combination of a procalcitonin value and a     simple evaluation of clinical status.   "
130809|NCT01572818|"     The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as     evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron     overload patients.   "
130965|NCT01570777|"     The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the     effectiveness and costs of renal denervation in addition to standardized medical treatment     compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal     denervation will be performed using the Symplicity Catheter - a percutaneous system that     delivers radiofrequency (RF) energy through the luminal surface of the renal artery.   "
130810|NCT01572805|"     The purpose of this study is to assess the effect of melatonin on pain and amount of blood     loss after cesarean delivery one hundred twenty women with singleton term pregnancy     undergoing elective or emergency lower segment cesarean section under spinal anesthesia were     included in this study. The patients were randomly allocated to one of three groups of 40     each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of     anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated     Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery     of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic     variables,will be recorded.Patients were instructed preoperatively in the use of the verbal     rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If     the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp     100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS     >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For     determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and     ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin     values were determined both before surgery and 12 h following surgery   "
130811|NCT01572792|"     The purpose of this Phase III study is to evaluate the long-term safety and tolerability of     two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium     bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic     Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related     quality of life assessments will also be evaluated. This extension study will include a 28     week treatment period, followed by a four week follow up visit. All patients will remain in     the same treatment group as for the lead-in study and continue on one of the four treatment     arms or placebo.   "
130812|NCT01572779|"     A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across     6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the     chronic group. The device records movement and muscle activity data relating to the lower     back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration     and aims to prompt the subject to alter their posture or position in line with     recommendations given by the treating practitioner. Four small sensors are adhered to the     lower back and send data wirelessly to a data logger carried in the pocket by the subject     (the size of a small mobile phone).   "
130813|NCT01572766|"     The study seeks to determine the impact of assessing risk for osteoporosis in women on     patient and physician behaviors through a pharmacist directed osteoporosis screening program.     Women will be offered a heel ultrasound to screen for their bone density and may or may not     be asked questions about their risk for bone fracture. Pharmacists will counsel and educate     all women on ways to prevent the onset of osteoporosis. Women will be telephoned three months     after the screening and asked a series of 10 questions to follow up on decisions made by     their physicians or changes made to their health behaviors related to bone health.   "
130814|NCT01572753|"     This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing     conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.   "
130815|NCT01572740|"     This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and     safety of liraglutide in combination with insulin therapy compared to insulin alone in     Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial     insulin therapy.   "
130816|NCT01572727|"     This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective     and safe in treating patients with HER2- locally advanced or metastatic breast cancer.   "
130817|NCT01572714|"     The objective of this study is to conduct a randomized controlled trial to examine the     effectiveness of a telehealth intervention that supports individuals in managing fatigue and     increasing physical activity (PA) behavior in individuals with multiple sclerosis (MS). The     hypothesis is that a fatigue management plus physical activity intervention will     significantly improve fatigue, quality of life, physical function, and community integration.   "
130818|NCT01572701|"     This is a single arm, open label study of up to 24 high risk prostate cancer patients     scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV     dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As     standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection     (PLND) within two weeks of study drug dosing. Patients may receive a second injection of     study drug within 24 hours of surgery to measure activity counts in tissue samples     post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated     for visible uptake and compared with histopathology.   "
130819|NCT01572688|"     The purpose of the study is to evaluate the safety and effectiveness of melphalan for     injection for autologous stem cell transplant in multiple myeloma   "
130820|NCT01572675|"     This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical     practice in France as well as the use of celecoxib (Celebrex®).   "
130821|NCT01572662|"     The goal of this clinical research study is to learn if giving busulfan and fludarabine     before a stem cell transplant can help control the disease better than the standard method in     patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of     busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan     and fludarabine during the week before the stem cell transplant, rather than the standard     method of giving 4 doses of busulfan and fludarabine only during the week before the stem     cell transplant.      The safety of this combination therapy will also be studied.      Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells),     which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants.      Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer     cells to die.   "
130929|NCT01571258|"     The purpose of the present RCT is to evaluate a 12-month SMS intervention with expanded     content, intervention strategies and interactive database logic, novel online enrollment, and     automatic baseline scoring of measures to support a 12 month weight loss SMS intervention.     The investigators hypothesized that the intervention group would have greater weight loss at     6 and 12 months than the control group and increased adherence to SMS would be associated     with greater weight loss at 6 and 12 months.   "
130822|NCT01572649|"     Primary Objective:      - To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as     compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric     population (10-17 years old) and adults as controls      Secondary Objectives:      - To evaluate in both paediatric and adult populations:        -  the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single          subcutaneous ascending doses        -  the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide          and glucagon plasma concentrations following a standardized breakfast        -  safety and tolerability.   "
130823|NCT01572636|"     This is a standard of care treatment guideline for patients with the diagnosis of     mucopolysaccharidosis type IH (MPS I, Hurler syndrome) who are being considered as candidates     for first hematopoietic stem cell transplantation (HSCT) according to a University of     Minnesota myeloablative HSCT protocol.   "
130824|NCT01572623|"     The purpose of this study is to evaluate the efficacy and safety of two different loading     doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural     ischemic brain damage in patients undergoing carotid angioplasty.   "
130825|NCT01572610|"     A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney     disease (CKD) patients with type 2 diabetes mellitus.   "
130826|NCT01572597|"     Compare efficacy and safety of 10-day triple therapy (rabeprazole, clarithromycin and     amoxicillin) plus N-acetylcystein versus 10-day concomitant therapy (rabeprazole,     clarithromycin, amoxicillin and metronidazole) for re-eradication for gastric Helicobacter     pylori infection.   "
130827|NCT01572584|"     Background        -  Assessment of the percentage of lung collapse is crucial in the therapeutic          decision-making of pneumothorax.        -  The methods normally used to this purpose are radiological. Computerized tomography scan          (CT) is highly accurate because it allows the exact evaluation of the volume of the air          layer. However, in clinical practice assessment of the volume of pneumothorax mainly          relies on the measurement of the inter-pleural distance at conventional chest          radiography (CXR). This latter method is inaccurate.        -  Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax,          with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax.        -  The scientific community is actually debating about the usefulness of lung ultrasound in          the quantification of pneumothorax []. Lung ultrasound can assess the superficial          extension of the pneumothorax, but cannot evaluate its volume.      Aim        -  Main purpose of the study is to compare measurement of the superficial extension of          pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air          volume performed by CT in patients with pneumothorax.        -  The main hypothesis of the study is that the cut-off between small (<11% of lung          collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung          ultrasound evaluation of the superficial extension of pneumothorax.        -  Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in          predicting the volume of pneumothorax assessed by CT.        -  Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the          prediction of volume of pneumothorax and percentage of lung collapse.      Methods        -  Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled and          submitted to lung ultrasound within 20 min from the CT study.        -  Different locations of the sonographic lung point on the chest wall (i.e. the point on          the chest wall where the sonographic pattern of the normally aerated lung alternates          with the pathologic sonographic pattern of pneumothorax) are compared with different          volumes of pneumothorax measured by CT.   "
130828|NCT01572571|"     Background        -  Symptomatic undifferentiated hypotension represents a negative prognostic factor and the          strongest predictor of in-hospital mortality.        -  Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening          conditions.      Aim      - The aim of the study is to evaluate the feasibility and accuracy of a new bedside     ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins,     in emergency.      Methods        -  Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of          at least one of the neurologic, respiratory and cutaneous signs and symptoms of          inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment          of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins.        -  On the basis of physical examination and ultrasound results, the operator declares the          diagnostic hypothesis without influencing the attending physician and the following          diagnostic procedure (which includes ultrasound, when needed).        -  The diagnostic hypothesis is compared with the final diagnosis, obtained after the          hospital route and discussed by a panel of three blinded experts (one radiologist, one          cardiologist and one emergency physician).        -  The statistical agreement is calculated by the k of Cohen with p-value, confidence          intervals and raw agreement (Ra).   "
130837|NCT01572454|"     We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease     the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients     undergoing off-pump coronary artery bypass graft, and trying compare these effects with those     of remifentanil infusion.   "
130829|NCT01572558|"     This is a feasibility study that will be performed at the Astrid Lindgren Children´s     Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients,     randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The     study will test an computerized randomization system, the availability of patients willing to     participate in the trial and the trial protocol. The investigators will assess the     characteristics of the patients who agree to participate in the study and those who do not.     The investigators will explore short term outcome and design suitable long term outcome     measures.   "
130830|NCT01572545|"     The primary aim of the study is the comparative effect of zolendronic acid versus denosumab     on serum sclerostin levels in postmenopausal women with low bone mass.      Secondary aims are their comparative effect on serum dickkopf-1, osteoprotegerin, receptor     activator of nuclear factor kappaB ligand (RANKL) and bone turnover markers (procollagen type     I N-terminal peptide [PINP] and C-terminal cross-linking telopeptide of type I collagen     [CTX]).   "
130831|NCT01572532|"     The primary aim of this study is to determine the impact of community-based screening and     treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19     weeks) on preterm live birth in Sylhet district, Bangladesh.      Hypothesis 1: Community-based screening and treatment of abnormal vaginal flora (Nugent score     >4) and urinary tract infections in early pregnancy (13-19 weeks) will reduce the population     rate of preterm live birth by at least 15%.      The secondary aims of this study are:        -  To determine the impact of community-based screening and treatment of abnormal vaginal          flora and urinary tract infections on the:             -  proportion of pregnancies with outcomes occurring prior to 37 weeks (late               miscarriage, preterm still birth and preterm live birth); and             -  proportion of babies with early onset neonatal sepsis.        -  To determine the prevalence of abnormal vaginal flora and urinary tract infections,          including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh.        -  To evaluate the accuracy of simple, low-cost, point of care diagnostic tests for          detecting bacterial vaginosis and urinary tract infections by community health workers          in a rural, developing country setting.   "
130833|NCT01572506|"     Background:      - Anemia occurs commonly and is associated with poor outcomes in the elderly. In about a     third of anemia cases in older people (over age 65), the cause of anemia is unexplained.     Anemia in older adults may be caused by the bone marrow's inability to produce red blood     cells fast enough to replace older red blood cells that have died. Researchers want to look     at unexplained anemia by studying the life span of red blood cells in younger adults and     older adults. To do so, a vitamin called Biotin will be used as a marker on the red blood     cells.      Objectives:      - To investigate possible causes of unexplained anemia in older people.      Eligibility:        -  Individuals in the following groups:        -  Men and women between 18 and 50 years of age who do not have anemia        -  Men and women at least 70 years of age who do not have anemia.        -  Men and women at least 70 years of age who have iron-deficiency anemia.        -  Men and women at least 70 years of age who have anemia with no known cause.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have an overnight stay for the first study visit. They will provide a          blood sample to which Biotin will be added. The blood sample with Biotin will then be          returned to the participant. Twenty-four hours later, another blood sample will be          collected.        -  Participants will have up to 14 additional study visits. At each visit, blood samples          will be collected to measure the amount of Biotin remaining in the blood.        -  Participants may also provide a separate blood sample for genetic testing. These tests          may provide more information about genetic causes of unexplained anemia.   "
130834|NCT01572493|"     Background:      - People with cancer can have a weak immune system as a result of the cancer itself, or from     prior treatments. . Still, treatments that stimulate the immune system have been shown to be     effective against a number of different cancers. Recombinant human interleukin-15 (rhIL-15)     is a drug that is designed to boost the immune system. Researchers are interested in seeing     if rhIL-15 can strengthen the immune system's response against cancer. The drug will be given     through a vein without a break for 10 days (240 hours).      Objectives:        -  To see rhIL-15 given as a continuous infusion over 10 days can be used to treat advanced          cancer        -  Identify the side effects associated with this treatment.      Eligibility:      - Individuals at least 18 years of age with advanced cancer for which there are no effective     treatments.      Design:        -  Participants screening procedures will include a physical exam and medical history,          laboratory (blood) tests and x-rays (Imaging studies) to determine suitability for the          protocol. --Appropriate participants with easily accessible tumor deposits may also be          asked to have one pretreatment and one post (cycle 1) treatment tumor biopsy. .        -  Eligible participants will be admitted to the hospital for the rhIL-15 treatment and          will spend about 12 days in the hospital. .        -  Participants will receive one 10 day infusion each cycle (about every 42 days) for as          long as there are no serious side effects and the disease does not progress.        -  Participants will continue treatment as long as imaging studies show that the tumor          continues to shrink or for two additional cycles after it has disappeared from the          x-rays to make that the cancer is completely gone.        -  Participants who stop treatment for side effects or because their tumor did not shrink          or stopped responding to the treatment will continue to have follow-up visits to monitor          the outcome of the rhIL-15 treatment until there is evidence their cancer has progress          or they begin another treatment.   "
130836|NCT01572467|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify biomarkers related to cancer.      PURPOSE: This research trial is studying genes in tumor samples from younger patients with     ovarian or testicular sex cord stromal tumors.   "
130839|NCT01572428|"     This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual     white light on the colon, will improve the detection of a type of polyp called serrated. The     polyps are called serrated because of their appearance under the microscope after they have     been removed. They tend to be located up high in the colon, far away from the rectum. They     have been definitely shown to be a type of precancerous polyp and it is possible that using     Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see     with standard white light.   "
130840|NCT01572415|"     The primary objective is to identify compare SCOUT DS to random capillary glucose for     identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.   "
130841|NCT01572402|"     Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will     be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and     in response to standard meals (at times 0', 30', 60', 120' and 180').   "
130842|NCT01572389|"     This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient     Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6     and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242     largely rural Veterans with uncontrolled diabetes and clinically-significant depressive     symptoms. Both groups will receive screening, education, and notification of clinical     findings along with follow-up in usual primary care. HOPE participants will also receive     behavioral coaching telephone sessions over a six month period. Patients in the control group     will be screened, and providers will be notified of high risk patients' status and need for     intervention. Both groups will receive only usual primary care during the subsequent 6 month     maintenance period. Study measurements using self-report questionnaires will also be     collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart     reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from     baseline will be compared between groups. This intervention will reach Veterans in rural     setting where community-based primary care is needed, especially care that blends treatment     strategies for physical and emotional health.   "
130843|NCT01572376|"     The aim of the study is to determine the safety and feasibility of an autologous mononuclear     stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the     efficacy of the treatment.   "
130854|NCT01572233|"     This 4-year project will be guided by a biobehavioral model for the study of exercise     interventions in two phases with the purposes to :        1. explore the patients' physical activity preferences and develop doable activity lists          during treatment period        2. examine the changes of health-related physical fitness component over interferon          treatment        3. develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test          its effects on decreasing fatigue, physical and psychological distress, and improving          their health-related physical fitness and quality of life in patients with chronic          hepatitis C receiving Interferon with Ribavirin Combination Therapy        4. evaluate the outcome of the PPAPE program on increasing adherence to therapy, the          sustained virological response (SVR) in 24 weeks after the end of treatment, and the          time-consuming for education program during intervention.   "
131177|NCT01568021|"     This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in     clinical practice, and will assess the time at which patients are considered for retreatment.   "
130844|NCT01572363|"     In patients with one anatomical or functional ventricular chamber, which encompasses a     spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in     view of an ultimate Fontan operation has become the procedure of choice. Especially in the     earlier era, perioperative mortality was the leading cause of death. However, many patients     have a long and high-quality life, continuously improved by a better understanding of Fontan     hemodynamics and the refinement of the surgical procedures. Nevertheless, the prospect of     eventual failure of the Fontan circulation remains a major concern. More specifically,     evaluation of the pulmonary circulation becomes particularly important as the failing Fontan     circulation has become a common indication for cardiac transplantation. Although essential,     especially in the preoperative setting, a comprehensive evaluation of the pulmonary     circulation remains difficult in this patient population      Our global hypothesis is that the absence of pulsatile pulmonary flow may lead to the     development of pulmonary vascular lesions after the Fontan operation and that - together the     absence of a subpulmonary ventricle for pressure generation - this increasing afterload will     result in systemic ventricular underfilling and will eventually lead to a failing Fontan     circulation.   "
130845|NCT01572350|"     This clinical trial is designed to investigate differences in terms of efficacy (mean change     in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3     therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser     alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.   "
130846|NCT01572337|"     A large multicentre, randomized, controlled trial to demonstrate that non invasive     ventilation given at an early stage of acute respiratory failure (ARF) outside the intensive     care unit (ICU) can prevent the deterioration of ARF and the need for ICU when compared to     the best available treatment usually performed in the non-ICU wards.   "
130847|NCT01572324|"     This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic     arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary     tract carcinomas, and to explore a better first-line treatment regimen for these patients.   "
130848|NCT01572311|"     The investigators proposed research will establish whether combining aerobic exercise with     cognitive challenges is feasible and effective in community dwelling older adults with early     signs of cognitive impairment.   "
130849|NCT01572298|"     When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of     bone may make it impossible to place a dental implant. Guided bone regeneration procedures     are used to re-establish a bone dimension sufficient to place a dental implant. The primary     objective of the study is to determine whether there is any difference in the gain of     horizontal alveolar ridge width following guided bone regeneration surgery using a combined     autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous     bone has historically been considered the gold standard for alveolar ridge grafting; however,     other materials including allografts and xenografts have also been used with excellent     results. This study evaluates the potential benefits, or lack thereof, for using a combined     autogenous/allograft approach versus an allograft alone. The investigators will clinically     evaluate the efficacy of this technique and determine the difference in bone formation     between groups following healing at 5 months by observing bone growth relative to heads of     the tenting screws placed horizontally in the locations of greatest defect in the alveolar     ridge. A biopsy of the healed site will be taken at the time of implant placement. The null     hypothesis is that there will be no difference in the amount of horizontal ridge width gain     at 5 months post-grafting between the two different grafting materials (allograft alone     versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that     histologically, the combination graft (MinerOss®/particulate autograft) will have a similar     percentage of vital bone present at 5 months compared to the allograft-alone group     (MinerOss®).   "
130850|NCT01572285|"     The purpose of this study is to determine whether transforaminal dexamethasone injections are     effective in the treatment of chronic Hemiplegic Shoulder Pain.   "
130851|NCT01572272|"     Primary:      The purpose of this study is to assess the clinical implications of continuous distal CO2     monitoring when used for clinical decisions      Sub Study:      • Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison to     the Carinal VitaLine set that its sampling tubing is made of PEBAX (dehumidifying material).      Description of Study Design:      Patients will be randomized at the baseline evaluation visit into one of the following     groups:        -  Masked group: Data derived from the Capnostream20p will be recorded; however the medical          staff will be masked from it and hence will not use it.        -  Open group: Data derived from the Capnostream20p and displayed to the medical team. It          will allow the treating physician and the nursing team to review the real time data and          make clinical decisions based upon it if felt necessary.   "
130852|NCT01572259|"     Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality     in insulin resistant states. The typical dyslipidemia that is associated with insulin     resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL)     with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to     play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48     overproduction appeared as a newly recognized component of insulin resistance. There is only     a limited amount of information in the literature regarding the factors and the mechanisms     modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance   "
130853|NCT01572246|"     This observational protocol will evaluate the effects of monopolar electrocautery (ME) on     implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause     electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge     (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will     be used to prevent patients from receiving inadvertent shocks. This requires the presence of     someone trained in ICD programming, but a trained person is not always readily available.      In this study the investigators will reprogram ICDs prior to surgery according to current     practice, but will also record what would have happened had the ICD reprogramming not     occurred (detection on but therapy off). In addition, the investigators will evaluate the     effect of the location of the electrosurgery unit (ESU) return pad on the incidence of EMI.     The investigators hypothesize that directing the current return path away from the ICD will     result in lower EMI rates than previously described.   "
130855|NCT01572220|"     The current study is designed to have broad generalizability and inform a potential shift     toward greater utilization of stress echocardiography with UCA. This will be accomplished by     comparing UCA stress echocardiography with myocardial SPECT among hospitalized patients     presenting with atraumatic chest pain. This study seeks to demonstrate: clinical     comparability of the 2 modalities (based on non-diagnostic test rates), improved care     efficiency (based on length of stay), lower costs, improved provider satisfaction, and a     presumed improved safety profile through the elimination of radiation exposure.      Primary Hypothesis: A strategy of routine UCA (Optison™) enhanced stress echocardiography     will result in a clinically non-diagnostic test rate comparable to myocardial SPECT among     patients hospitalized (inpatient or hospital observation status) with atraumatic chest pain.   "
130856|NCT01572207|"     The purpose of this research study is to evaluate whether tailored print material can promote     physical activity and exercise, and subsequently improve quality of life and fitness levels     among people with multiple sclerosis (MS). Research suggests that routine physical activity     is beneficial in people with mild to moderate MS. However, people with MS may face many     barriers for engaging in regular physical activity. Prescribing a home exercise program and     receiving tailored motivational print material may help people engage in physical activity.     Thus, the investigators hope to figure out whether tailored print material can be used as     strategy to promote physical activity and improve physical function in people with MS.   "
130857|NCT01572194|"     Chronic renal failure is a serious complication of lung transplantation especially in     patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has     already exposed to kidney damage. Post-lung transplantation, these patients are subjected to     renal toxicity anticalcineurins they receive large doses.      The measurement of renal function of patients by formula to estimate GFR in routine use is     unreliable and other markers seem indispensable.      The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal     peptide N), whose urinary levels was correlated to the intensity of fibrosis in different     types of kidney disease.   "
130858|NCT01572181|"     The purpose of this study is to assess transplant-related mortality (TRM) at one year after     allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a reduced     toxicity myeloablative conditioning regimen in young patients (children and adolescents)     with hematologic malignancies.   "
130859|NCT01572168|"     Cancer-related fatigue occurs in both adult and pediatric patients undergoing chemotherapy     and/or radiation. Recently, methods to measure fatigue have improved - however, no     non-medication interventions have been studied. Ameliorating fatigue may result in an     improved quality of life for patients. Acupuncture is a safe and well-tolerated procedure and     has been used for many indications in pediatric patients. Adult studies have suggested     improvement in cancer-related fatigue after acupuncture in adults. In this trial, we propose     using acupuncture for the treatment in cancer-related fatigue in children and adolescents     with central nervous system tumors.   "
142924|NCT01413646|"     The purpose of this study is to examine the effects of walnut consumption on endothelial     function and lipid markers in overweight patients with at least one factor of metabolic     syndrome as compared to the control group.   "
130860|NCT01572155|"     Hypothesis:      Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and     represents a new therapeutic approach to shorten postoperative ileus.      Aims:      In the present pilot study, the investigators want to evaluate the anti-inflammatory effect     of peroperative electrical stimulation of the vagus nerve. To this end, the following aims     are formulated:        1. to optimize the technique of intra-operative electrical vagus nerve stimulation        2. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the          inflammatory response to abdominal surgery        3. to evaluate whether electrical stimulation of the vagus nerve leads to clinical          improvement (collect pilot data)   "
130861|NCT01572142|"     The overarching goal of this prospective cohort study is to test the hypotheses that greater     severity of hyposmia is associated with increased risk of cognitive decline in PD and that     worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals     of this project, patients with PD without dementia or at-risk of dementia or with dementia     will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE     [11C]PMP or VAchT (vesicular acetylcholine transporter) [F18]-FEOBV PET will be performed     both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be     performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will     be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be     performed to better understand dynamic changes underlying the clinical and PET outcome     measures.   "
130862|NCT01572129|"     Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with     aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous     coronary intervention.      The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in     patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous     coronary intervention.   "
130863|NCT01572116|"     The aim of this study was to compare the effects of Lidocaine/epinephrine with and without     Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in     teeth with irreversible pulpitis.   "
130864|NCT01572103|"     Background: In patients with chronic HCV-related liver damage, coffee is associated with a     reduced risk of progression and of hepatocellular carcinoma (HCC) development. Aim: This     prospective trial is aimed at assessing the mechanisms underlying the protective effect of     coffee on evolution in cirrhosis and HCC. Trial design/methods: Forty patients with     HCV-related hepatitis will be recruited and randomized into two groups: the first will     consume 4 coffee cups/day/1 month, while the second will remain coffee abstinent. At day     30, the two groups will be switched over and exposed to coffee or not for a second month.     Before entering the study (time 0), during coffee exposure and during abstinence we will     evaluate the following parameters: liver function tests, viral load, 8-hydroxydeoxyguanosine     (a marker of oxidative DNA damage), telomere length, apoptosis and collagen deposition.   "
131178|NCT01568008|"     This is an observational study in patients with POAG or OHT that will collect data on the use     of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting.     Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after     baseline, as per normal clinical practice.   "
130865|NCT01572090|"     Patients with overweight or obesity are in need to loose weight and represent a particularly     challenging medical condition. Undoubtedly, any intervention achieving a negative energy     balance over an extended time period will result in weight loss. Although several treatment     modalities are available, currently the most extended approaches are lifestyle changes,     pharmacotherapy, and bariatric surgery. Given the limited approved anti-obesity drugs, the     main therapeutic strategies involve either conventional treatment or bariatric surgery.     Conventional weight-reduction programs pursue a safe weight loss rate of 0,5-1,0 kg per week.     The main modifiable factors affecting energy balance are dietary energy intake and energy     expended through physical activity. In spite of the difficulty in achieving relevant and     sustained weight loss via the conventional approach, some patients are successful in reducing     weight and obesity-associated complications. Bariatric surgery has proved to be the most     effective long-term treatment for weight loss and comorbidity improvement. While some of the     surgery-induced benefits are directly dependent on adipose tissue reduction, others are due     to specific gastrointestinal changes that take place early on and before any significant     effects on body weight are observed. The present study contemplates the determination and     comparison of the anthropometric and metabolic changes produced by the conventional and     surgery-induced treatment modalities. Particular emphasis will be placed on the potential     differential effects between conventional and surgical weight loss on body composition     changes, circulating adipokines and gastrointestinal hormones together with their subsequent     impact on cardiometabolic risk factors.   "
130866|NCT01572077|"     The purpose of this study is to evaluate patterns of metabolic activity in the heart of     patients with pulmonary arterial hypertension(PAH). Patients with PAH are at risk of     developing weakness or failure of the right side of the heart.It is possible that there is a     relationship between the development of heart failure and the way the heart uses energy     sources, such as sugar. This study is designed to evaluate the way the heart uses sugar     uptake in patients with PAH using positron emission tomography(PET imaging)   "
130867|NCT01572064|"     The main purpose of this pilot study is to evaluate non-invasive magnetic resonance imaging     (MRI) techniques in the detection and grading of liver fibrosis, so that the investigators     can reduce the need of invasive techniques such as liver biopsy and transjugular hepatic     venous portal pressure gradient (HVPG) measurements to assess the degree of liver scarring     and portal hypertension.   "
130868|NCT01572051|"     Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of     patients. Patients can become disabled early in life by OA. The Osteoarthritis Research     Society International (OARSI) is concerned to publish guidelines with the respective levels     of evidence on the various forms of treatment of osteoarthritis of the knee and hip.It is     believed that an education program has a positive impact on quality of life of patients with     OA. Changing the habits of those patients is imperative for clinical improvement.      The investigators propose the creation of an educational program consisting of various health     professionals so that we can educate the patients about OA disease, and their role in     treatment. This program will be administered in a single day and reviewed/reinforced after an     interval of time. Half the patients will be monitored monthly by phone when questions     specific to each health area will be made to participants. This way we will evaluate the     strength of the telephone follow-up. The investigators are going to create educational     printed an audiovisual materials for patients, so the patients can access the information     given in the theoretical course at home. Calculation of cost-effectiveness and presentation     of data to the authorities.   "
130869|NCT01572038|"     This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and     tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane     (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with     metastatic or locally recurrent HER2-positive breast cancer. Participants will receive     pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3     weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease     progression, or death, whichever occurs first.   "
130870|NCT01572025|"     -  To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to          and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved)          and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and          IVF/ICSI treatment.        -  To evaluate the feasibility of conducting a large multicentre trial   "
130871|NCT01572012|"     This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of     ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously,     intramuscularly, and orally in normal healthy volunteers.   "
130872|NCT01571999|"     This study will assess the safety and pharmacokinetics of inhaled GSK573719 and     GSK573719/vilanterol combination in healthy subjects and in subjects with severe renal     impairment. The results of the study will provide guidance on the use of this product in     subjects with severe renal impairment.   "
130873|NCT01571986|"     A single center, observational, prospective study to improve knowledge about non-invasive     ventilation, obtaining data about compliance, efficacy, imaging in patients who already     receive non-invasive ventilation as standard of care.   "
130874|NCT01571973|"     The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of     depressed outpatients.   "
130875|NCT01571960|"     This study will test the safety and immune responses of a prime-boost regimen of two HIV     vaccines— a DNA vaccine followed by a modified vaccinia Ankara (MVA) vaccine— in healthy,     HIV-uninfected, vaccinia-naive adults.   "
130876|NCT01571947|"     There is increasing evidence suggests that elevated levels of postprandial triacylglycerol     (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A     prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a     variety of mechanisms such as insulin resistance, inflammation, endothelial dysfunction and     oxidative stress. However, current evidence on the acute effects of type of fats on     postprandial insulinaemia, gastrointestinal peptide secretion, inflammatory response, as well     as satiation are limited and inconsistent, in particular in metabolic syndrome population in     Asian. Hence, this study aimed to investigate the postprandial effects of high fat meals     enriched with i) palm olein, ii) high oleic sunflower oil, and iii) high linoleic sunflower     oil, compared with a low fat/high carbohydrate meal, in 30 subjects with metabolic syndrome.   "
130877|NCT01571934|"     Hemophilia A is a genetic deficiency of factor VIII that causes blood to clot too slowly. The     disease is classified based on how much factor VIII is in the blood. People with mild or     moderate hemophilia A have low, but detectable, blood levels of factor VIII and bleed with     trauma or surgery. At the time of surgery, they need to receive factor VIII replacement by     infusion into the vein so that blood can clot normally and abnormal bleeding can be avoided.     A complication of hemophilia A is the development of an antibody that binds factor VIII and     makes the factor VIII infused for treatment not work properly. This antibody is called an     inhibitor. In mild and moderate hemophilia A, inhibitors are not common, but have been     reported to occur after intensive factor VIII infusions, as may occur at the time of surgery.     This study is designed to observe people with mild and moderate hemophilia A who are having     surgery. Information on the surgery, treatments given, bleeding, and infection will be     gathered. Also, blood will be drawn to determine how the immune system is reacting to the     factor VIII. No specific treatments will be given as part of this study. We will use the     information to determine what influences inhibitor development. A better understanding of     inhibitor development will help medical providers do things to avoid inhibitor development in     this population or researchers to design new treatments.   "
130878|NCT01571921|"     Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written     informed consent to participate in the trial will be recruited to compare the rate and extent     of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.   "
130879|NCT01571908|"     Magnesium accelerates the reaction of rocuronium, a neuromuscular blocker used for muscle     relaxation to ease the intubation during anaesthesia.      Succinylcholine is a very fast reacting neuromuscular blocker. It is often used in emergency     procedures, when rapid intubation is necessary.      We want to now if a perfusion of magnesium before anaesthesia accelerates to such an extent     the reaction of rocuronium that intubation conditions are comparable or even better than with     succinylcholine alone (prior perfusion of saline=placebo)   "
130880|NCT01571895|"     The study will be a phase 2, multicentre, single arm, pilot study. It has been designed to     determine if DF2156A has sufficient activity to warrant its further development.      A total of twelve (12) BP patients will be involved, who will be administered DF2156A orally     at the dose of 150 mg twice a day for a maximum of 14 days.      Recruitment will be competitive among the study sites, until the planned number of patients     is enrolled. Competitive recruitment has been chosen to increase the speed of recruitment and     to account for any unexpected occurrence at a site that negatively impact enrolment rate.      The single arm design has been chosen as an appropriate tool for this pilot phase 2 study,     considering that BP is a rare disease where a placebo control is not acceptable. Moreover, as     there is no spontaneous acute recovery from the active blistering condition, any improvement     in patient outcome can be attributed to a positive effect of the Investigational Product.      Each patient will be involved in the study for a screening period, for 14 days of treatment,     for all required measurements up to hospital discharge (planned on day 8+1 of treatment) and     for one assessment occasion on day 15+1, either during hospital stay or after hospital     discharge (out-patient visit). An optional post-treatment visit might be scheduled at day     30+3.      The objective of this clinical trial is to evaluate whether DF2156A has a potential in     improving the clinical outcome in patients with active blistering BP to warrant its further     development. The safety of DF2156A in the specific clinical setting will be also evaluated.   "
142925|NCT01413633|"     The investigators describe a novel technique for GB fundus retraction.   "
130885|NCT01571830|"     -  Hypothesis 1: Food allergies are associated with poor growth which can be corrected with          nutrition intervention.             -  More than 10% of children with multiple food allergies will have a weight-for-age               z-score less than - 2 at diagnosis. The z-score is a measure of the distance from               the mean value, or 50th percentile on the growth chart. A z-score of less than - 2               indicates that the child is underweight.             -  Growth parameters of children with multiple food allergies will improve after               intervention by a team that includes a dietitian and an allergist.        -  Hypothesis 2: Food allergies are associated with low micronutrient intake which can be          corrected with nutrition intervention.           o More than 30% of children with multiple food allergies will consume less than 67% of          the Dietary Reference Intake for at least one macronutrient or micronutrient at          diagnosis.        -  Macronutrient and micronutrient intake will increase after intervention by a team that          includes a dietitian and an allergist.      • Hypothesis 3: Food allergies are related to behavioral feeding problems which can be     corrected with nutrition intervention.        -  At least 25% of children with multiple food allergies will have behavioral feeding          problems at diagnosis.        -  Prevalence of behavioral feeding problems will decrease after nutrition intervention.   "
130886|NCT01571817|"     The overall objective of this pilot project is to evaluate the safety and efficacy of the     gastric submucosal space as a novel site for clinical islet transplantation. The site has     several physiologic attributes that may improve the outcomes of islet transplantation     compared with the conventional intraportal transplant site.   "
130887|NCT01571804|"     Preoperative administration of pregabalin would reduce the end tidal concentration of     sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the     quality of postoperative analgesia.   "
130908|NCT01571531|"     Today there is accumulating evidence from animal experiments that regeneration can be induced     after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches     to induce some regeneration will be included in the treatment of patients with SCI. The aim     of this proposal is to provide the required clinical basis for the implementation of novel     interventional therapies. The establishment of combined clinical, functional and     neurophysiological measures for a qualitative and quantitative assessment of spinal cord     function in patients with SCI at different stages during rehabilitation represents a basic     requirement to monitor any significant effect of a new treatment. Therefore, several European     Paraplegic Centres involved in the rehabilitation of acute traumatic SCI patients build up a     close collaboration for standardised assessment. The aim is to get knowledge about the     natural recovery after spinal cord lesion in a larger population of patients in the sense of     a historical control group and to bring new standardised assessment tools to the clinical     setting.   "
130888|NCT01571791|"     Rheumatic heart valve diseases are prevalent among the young people in Egypt secondary to the     socioeconomic conditions. The goal of anesthetic management of these patients is maintenance     of sinus rhythm, systemic blood pressure, preload, coronary perfusion, and cardiac output.     Many women still prefer general anesthesia rather than regional techniques at the author's     country.      The pharmacological modifications of the sympathetic response to tracheal intubation and     surgical stimulation using opioids have adverse effects on the neonatal outcome after     cesarean delivery. The authors have demonstrated in their previous studies the safety of both     perioperative infusion of both of ketorolac and lidocaine in the attenuation of the     hemodynamic and hormonal responses of tracheal intubation and surgery during cesarean     delivery with favorable neonatal outcome and without added risk of perioperative bleeding.     Therefore, the authors reported successful anesthetic management of a parturient with     infective endocarditis on top of rheumatic mitral valve disease with use of     paracetamol-lidocaine-ketorolac-propofol anesthesia.      The investigators hypothesize that the perioperative use of ketorolac-lidocaine would reduce     the maternal hemodynamic responses to intubation and surgery without any harmful effects on     mother or baby during uncomplicated cesarean delivery in the parturients with valvular hear     diseases.      The investigators are aiming to compare the effects of ketorolac-lidocaine and fentanyl on     surgical stress responses, intraoperative fentanyl and vasoactive drugs consumption and     neonatal outcome during cesarean delivery in the parturients with valvular hear diseases.   "
130889|NCT01571778|"     The importance of healthcare worker hand hygiene in decreasing bacterial transmission between     patients is well documented. Healthcare workers may don non-sterile gloves in routine care of     patients, particularly for those patients known or suspected to harbor epidemiologically     important microorganisms. Governing bodies currently recommend performing hand hygiene prior     to donning gloves and after glove removal. The importance of hand hygiene post glove removal     is well shown, however few studies exist to show utility of hand hygiene prior to donning     gloves. In fact, data suggests that glove use is an impediment to hand hygiene and may reduce     compliance with hand washing. In light of this and the fact that no evidence exists that     washing hands BEFORE glove use is important, the aim of the study is to asses the utility of     routine hand hygiene prior to donning non-sterile gloves before a patient contact.   "
130890|NCT01571765|"     The investigators will assess whether in Bushenyi District in southwestern Uganda, a two year     intervention providing comprehensive MNCH programming will:        -  Reduce morbidity and mortality for children under five years old and;        -  Improve access to maternal health services Compared to a control community without MNCH          intervention?      Hypothesis:      Comprehensive maternal, newborn and child health programming in Bushenyi Distrcit can have a     positive impact on morbidity and mortality for children under five years and will improve     access for women to maternal health services which may lead, in the longer term, to decreased     maternal mortality.   "
130891|NCT01571752|"     Background:      - Researchers have been studying patterns of mood and drug use in specific neighborhoods.     This study will look at environmental factors that may affect drug use, addiction, and     treatment seeking in Baltimore neighborhoods. The results could inform prevention efforts,     enhance treatment interventions, and improve substance use outcomes.      Objectives:      - To better understand why some people start to use drugs, why some people who use drugs     become addicted, and why some people who become addicted enter treatment.      Eligibility:      - Individuals at least 18 years of age who are living in the neighborhoods participating in     the study.      Design:        -  Participants will be screened with a physical exam and medical history. They will be          separated into one of four groups: (1) people who do not use drugs, (2) people who have          used drugs in the past, (3) people who are using drugs and want treatment, and (4)          people who are using drugs and do not want treatment.        -  This study will include two outpatient visits about 12 months apart. Each visit will          last about 5 hours. Each study visit may be done in 1 day or in 2 days.        -  At each study visit, participants will provide blood, breath, urine, and saliva samples.          They will also have a heart function test and body measurements. They will complete          questionnaires about personal and family history.        -  There will be monthly follow-up phone calls between the two visits.   "
130906|NCT01571557|"     This study will evaluate the relationship between time since onset of macular oedema symptoms     and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic     procedures provided are at the discretion of the participating physicians according to their     clinical judgment and local standard of medical care.   "
130892|NCT01571739|"     Background:      - Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB     bacteria but have not become sick are said to have latent TB. Many people with latent TB will     not get sick from it, but some people will develop active TB and become sick. Much is known     about how to treat and diagnose active TB, but little is known about the best way to treat     latent TB. Researchers also want to know more about the risk that latent TB will develop into     active TB, and whether it is possible to test for this risk.      Objectives:      - To test possible methods of determining a person s risk for developing active TB.      Eligibility:      - Individuals between 20 and 60 years of age who (1) have active TB, (2) were exposed to     someone with active TB in the past 9 months, or (3) have not been exposed to TB.      Design:        -  Participants will be separated into groups based on their exposure to TB.        -  Healthy participants who were not exposed to TB will answer questions about their          medical history. They will also provide blood and urine samples.        -  Participants who have active TB will have a physical exam and medical history. They will          provide blood, urine, and sputum samples, and will have a chest x-ray. They will be          treated with the standard of care for active TB. Some participants with active TB may          have additional tests as part of this study.        -  Participants who were exposed to TB and have latent TB will have a physical exam and          medical history. They will provide blood, urine, and sputum samples, and will have a          chest x-ray. They will be asked to return for five more clinic visits over the next 12          months to repeat these tests. They may also have additional chest imaging studies          depending on the study needs.        -  Some of the exposed participants may have been exposed to drug-resistant TB. These          participants will receive the drug isoniazid to take on a regular schedule to help          prevent the latent TB from becoming active TB.   "
130909|NCT01571518|"     After resection of lymph node positive breast cancer, the injection duration and timing of     Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC     (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.   "
130911|NCT01571492|"     This prospective study is intended to compare the analgesic efficacy, preservation of lower     extremity motor power and side-effect profile of L2 Paravertebral lumbar plexus approach     compared to Posterior nerve stimulation guided lumbar plexus approach, continuous local     anesthetic infusion postoperative analgesia of Total Hip Arthroplasty.      The L2 Paravertebral technique of lumbar plexus block, as part of a multimodal pain     treatment, could be a cost-effective alternative with a equal profile of analgesic efficacy     and motor power sparing with greater promotion of early achievement of postoperative physical     therapy goals.   "
130893|NCT01571726|"     Background:      - Multiple myeloma (MM) is a type of malignant blood cancer. It affects the plasma cells,     which help produce antibodies and fight infection. MM is nearly always preceded by a     pre-malignant state, monoclonal gammopathy of undetermined significance (MGUS) or smoldering     multiple myeloma (SMM). Currently, it is not possible to predict when someone with MGUS or     SMM will develop MM. Also, the disease changes in those early states are not well understood.     Researchers want to look at imaging studies of people with MGUS, SMM, and MM. They will study     whether the growth of blood vessels can be used to predict disease progression.      Objectives:      - To use imaging studies to evaluate disease progression in multiple myeloma.      Eligibility:      - Individuals at least 18 years of age who have MGUS, SMM, or newly diagnosed MM.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests, and provide bone marrow samples.        -  Participants will have positron emission tomography (PET) scans with the new contrast          agent [18]F-Fluciclatide. The contrast agent is intended to show patterns of increased          vessel growth in the bone marrow.        -  Participants will also have a magnetic resonance imaging (MRI) scan. This scan will be          done according to standard procedures.        -  Researchers will compare these scans with blood tests and other clinical information to          study disease progression of MGUS, SMM, and MM....   "
130894|NCT01571713|"     The study seeks to analyze the patient reported effects of pulmonary hypertension medications     and compare these with the side effects described on the package inserts. Side effects for     these PH medications have been described in the adult population, but have never been     described in the pediatric population. This information can better improve patient care and     be used to characterize the side effects resultant from these medications.   "
130895|NCT01571700|"     The purpose of the study is to determine whether patients with pulmonary hypertension (PH)     have dysynchrony, and if so whether it is electrical or mechanical. Once this has been     determined, during a catheterization the investigators will test if pacing the heart improves     blood circulation.   "
130896|NCT01571687|"     Exposure to hypobaric hypoxia demands maximum effort of the body and can lead to high     altitude illnesses. Recently, there is rising interest on coagulation activation during     trekking and mountaineering in higher regions and on development of oxidative stress due to     hypoxia. 30 volunteers have been examined during an high altitude research expedition to the     7134m high mount Pik Lenin in Kyrgyzstan to investigate mechanisms of coagulation activation     and effects of antioxidant supplements on oxidative stress.   "
130897|NCT01571674|"     The purpose of this study is to determine the validity of previously identified prognostic     variables that may identify patients with shoulder pain that are likely to benefit from     cervicothoracic spine manipulation.   "
130898|NCT01571661|"     This is a double blind, randomised, placebo controlled, single dose escalation,     first-time-in-human, 5-way crossover study to assess the safety, tolerability,     pharmacokinetic and pharmacodynamic parameters of ascending doses of GSK189075A in healthy     subjects (Part A). Single doses will be given to 10 healthy subjects. The planned doses are     20mg, 50mg, 150mg, 500mg, and 1000mg. Each subject will receive 4 of the 5 active doses and a     placebo separated by a washout of 5-10 days. A second cohort of 6 subjects with type 2     diabetes mellitus will receive 2 active doses and a placebo along with oral glucose in a     three-way, randomised, placebo controlled, crossover design to assess glucose lowering     following GSK189075A administration (Part B). Blood samples will be taken throughout the     study day for pharmacokinetic analysis of prodrug and metabolites. Safety will be assessed by     measurement of blood glucose, blood pressure, heart rate, ECGs, laboratory safety screens,     and collection of adverse events.   "
130899|NCT01571648|"     The purpose of this study is to evaluate the tolerability of oral azacitidine in the     treatment of patients with Myelodysplastic Syndromes (MDS).   "
130900|NCT01571635|"     Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in     adults with Beta (β)-Thalassemia   "
130901|NCT01571622|"     The aim of the present study is to examine the therapeutic effect of whey protein concentrate     (WPC 80) in adult subjects with in type 2 diabetes. Whey protein will be administered before     breakfast and its effects on posprandial glucose, insulin, c-peptide, intact and total GIP     and GLP-1, and DPP-4 plasma levels will be assessed.   "
130902|NCT01571609|"     The purpose of the present study is to conduct a thorough and relevant physiology study of     carriers and non-carriers of the gene variant X in order to determine the effect of the     genetic variant on various metabolic parameters.   "
130903|NCT01571596|"     The primary purpose of this study is to assess the safety and efficacy of repeated     subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).   "
130904|NCT01571583|"     The purpose of this study is to evaluate the effectiveness of telaprevir in combination with     Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C     virus (HCV) genotype 1.   "
130905|NCT01571570|"     The purpose of this study is to evaluate the relative bioavailability and the short-term     safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg,     given as different formulations in healthy adult participants. In addition, this study is to     assess for the acceptability of the taste of both liquid formulations.   "
142945|NCT01413373|"     Development of three-dimensional craniofacial cephalometric analysis for virtual planning in     orthognathic surgery.   "
130907|NCT01571544|"     Unintentional hypothermia of a patient is a common adverse effect during surgical procedures.     The aim of this prospective, randomised, controlled study is to determine whether the use of     thermal suit could prevent surgical patient from experiencing thermal loss than conventional     measures.      Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between     the groups is clinically relevant.   "
130912|NCT01571479|"     The aim of this study was to show that this technique is feasible, safe and easily     reproducible and to evaluate the selection criteria for a three-port laparoscopic     cholecystectomy using a 2-mm mini-port.   "
130913|NCT01571466|"     30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be     randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be     observed at the Investigation Unit of the study site for one hour following vaccination. At     week 24 they will stop their HAART until the end of the study.   "
130916|NCT01571427|"     Past epidemiological studies have demonstrated that larger social networks, or more frequent     social interactions, could have potential protective effects on the incidence of Alzheimer's     Disease (AD). However, in those studies, indicators of social interactions were often broad,     and included distinct elements that affected cognition and overall health. the investigators     will examine whether conversation-based cognitive stimulations have positive effects on     general, and domain-specific cognitive functions among the elderly. Face-to-face     communication will be conducted through the use of personal computers, webcams, and     user-friendly simple interactive Internet programs to allow participants to have social     engagement while staying at their home and also for the cost effective execution of the     study.   "
130917|NCT01571414|"     Tuberculosis (TB) is a global public health concern and developing new treatment regimens is     an important research priority. PA-824 is an experimental TB medication. This study will     evaluate the safety and tolerability of PA-824 when combined with efavirenz (EFV) or     ritonavir-boosted lopinavir (LPV/r), which are medications used to treat HIV infection, or     rifampin (RIF), which is a medication used to treat TB. Study researchers will examine the     safety and tolerability of these drug combinations and how the medications affect the levels     of PA-824 in the blood.   "
130918|NCT01571401|"     Objectives: The purpose of this study is to find out if a new program can help kidney cancer     survivors (KCS) increase their physical activity (PA) and improve their quality of life     (QoL).      Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry.     Participants will undergo submaximal exercise testing, a physical function test and measures     of height and weight, which will be completed at baseline and the end of the physical     activity program (at 12 weeks). Participants will also complete questionnaires on PA and QoL     at the baseline, after the supervised portion of the program (at 4 weeks), and at the end of     the entire program (at 12 weeks). Following baseline assessments, participants will be     randomly assigned to either: (1) supervised physical activity plus traditional exercise     counseling or (2) supervised physical activity plus behavioural counseling. Participants will     be asked to attend six individual supervised exercise and counseling sessions over a 4-week     period with a PA specialist that eventually tapers to a home-based program by the end of the     program.      Implications: The investigators hope that this PA intervention for KCS is feasible and     results in meaningful improvements in health outcomes that can be translated to public health     practice.   "
130919|NCT01571388|"     The study will determine if there are differences in how dacomitinib is absorbed and     eliminated between healthy subjects and subjects with mild and moderately impaired hepatic     function.   "
130920|NCT01571375|"     The Aim of the Study is to Measure the Effect of Finnish Physician-staffed EMS Unit Treatment     Methods on Traumatic Brain Injury (TBI) Patient Prognosis.      Physician-staffed HEMS unit was implemented to the EMS 2011. The aim of this study is to     compare the results against a historical database to see if the implementation of a HEMS unit     will improve the prognosis of TBI patients.   "
130921|NCT01571362|"     The primary objective of the study is to determine the analgesic efficacy and safety of     ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to     severe chronic low back pain.   "
130922|NCT01571349|"     The investigators are trying to investigate the coagulation status of idiopathic (immune)     thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von     Willebrand factor level, thromboelastography.   "
130923|NCT01571336|"     This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during     an interval of two years after Alacare®-PDT.   "
130924|NCT01571323|"     The purpose of this study is to demonstrate that the combined used of low dose of oxytocin     and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol     alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing     elective or emergency lower segment cesarean section under spinal anesthesia were included in     this study. The patients were randomly allocated to one of three groups of 50 each. The     oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after     delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved     in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately     after delivery of the neonate ,The misoprostol group (groupM) received 400 µg sublingually     and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined     misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously     immediately after delivery of the neonate . The main outcome measures were blood loss at     cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related     side effects.The volume of blood in the suction bottle was measured, blood soaked sponges and     added to volume from suction bottle. Hemoglobin values were determined both before surgery     and 24 h following surgery. Hemodynamic variables were recorded every 5 minutes during     surgery .The need for additional oxytocic therapy, operating time, infusion volume given     intraoperatively, need for blood transfusion, side effects of study drug and any significant     puerperal morbidity were also recorded.   "
130925|NCT01571310|"     The investigators will explore the effect of omission of breakfast on postprandial     hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2 diabetic     patients   "
130926|NCT01571297|"     The purpose of this study is to evaluate the effects of RM-131 on gastric emptying,     gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in     patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to     evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 and     placebo) will be administered subcutaneously in a blinded fashion.   "
130927|NCT01571284|"     Primary Objective:      To provide metastatic colorectal cancer patients with access to aflibercept and to document     the overall safety in these patients      Secondary Objective:      To document the Health-Related Quality of Life of aflibercept in this patient population   "
130928|NCT01571271|"     Bile duct stones that can't be removed by conventional means can often be removed after     fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation     of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser     (laser lithotripsy). Although both techniques have been used for many years, there are no     studies comparing the efficacy of the two. The purpose of this study is to find out which     technique is more effective.   "
130930|NCT01571245|"     Objective psychophysiologic reactivity data may be useful for predicting post-traumatic     stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack     of a clearly superior treatment, a reliable and valid approach to predicting treatment     response is needed.      Specific Aims: 1). Evaluate the clinical utility of psychophysiologic reactivity measures to     predict overall PTSD symptom response among OEF/OIF/OND (Operation Enduring Freedom/Operation     Iraqi Freedom/Operation New Dawn) veterans receiving treatment for PTSD. 2). Evaluate the     clinical utility of psychophysiologic reactivity measures to predict psychosocial functioning     and health-related quality of life (HRQoL) response among OEF/OIF/OND veterans in treatment     for PTSD. Exploratory). Develop psychophysiologic, neuropsychological, and/or self-report     models to predict PTSD symptom response to pharmacotherapy, psychotherapy, and combined     pharmacotherapy/psychotherapy. The investigators will divide psychophysiologic reactivity     predictors into two groups: heart rate variability and attentional bias (eye gaze tracking     and modified Stroop). The investigators will collect observational and longitudinal data from     a treatment-seeking sample of 50 OEF/OIF/OND veterans with PTSD recruited from the Central     Arkansas Veterans Healthcare System (CAVHS) Mental Health Clinics.   "
130931|NCT01571232|"     The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone     implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant     diabetic macular edema.   "
130932|NCT01571219|"     CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc.     This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion,     efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess     the long-term efficacy and safety of multiple doses of CT-P13.   "
130933|NCT01571206|"     This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion,     efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess     the long-term efficacy and safety of multiple doses of CT-P13.   "
142946|NCT01413360|"     The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis     patients whose serum liver enzymes are elevated more than upper limit.   "
130934|NCT01571193|"     In the present study, the investigators will examine and determine whether pomegranate     extract benefits cognitive abilities in middle-aged and older non-demented volunteers. More     specifically, the investigators will test the following primary hypothesis:        1. Non-demented volunteers aged 50-75 who receive a daily dietary supplement of pomegranate          extract will show improved cognitive performance compared to baseline versus those          receiving a placebo after one, six, and twelve months.           The investigators will also explore the following secondary hypothesis:        2. Cognitive change in the pomegranate intervention group will vary according to genotypes          found to influence age-related cognitive decline (i.e., apolipoprotein E [APOE]).   "
130935|NCT01571180|"     Patients who have scheduled a gastric bypass (RYGB) in UZ Leuven, will be questioned     preoperatively and one, three, six and twelve months after gastric bypass surgery. The     purpose of this study is to explore current practice regarding the use of medication and     medication counseling after RYGB and to examine the changes in dietary pattern before and     after RYGB.   "
130936|NCT01571167|"     The primary purpose of the study is to determine the effects of treatment with varenicline (1     and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and     subjective effects in methamphetamine-dependent human volunteers.   "
130937|NCT01571141|"     Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the     development of cervical cancer. Persistence of the infection is one of the main factors     responsible for the invasive progression and women diagnosed with intraepithelial squamous     lesions are referred for further assessment and surgical treatments which are prone to     complications. Despite this, there are several reports on the spontaneous regression of the     infection.      In this study the investigators will evaluate the effectiveness of a long term     polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance     reducing the time exposure to the infection and avoiding the complications associated with     the invasive treatments currently available.      Women diagnosed with HPV infection were randomly assigned to receive six months of treatment     with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same     period of time.      The administration of Monogin® has been performed every three days for fifteen days and then     every fifteen days for the subsequent six months.   "
130938|NCT01571128|"     MP3 Youth is a pilot study to evaluate the feasibility and acceptability of a gender-specific     combination HIV prevention package for youth (aged 15-24) in high burden settings. The study     aims to pilot a combination package of gender-specific interventions in western Kenya in a     mobile health delivery format using integrated services delivery.   "
130939|NCT01571115|"     INTRODUCTION: The primary insomnia, according to the concepts of the DSM IV, is a disorder     characterized by difficulty initiating or maintaining sleep, waking early or by     non-restorative sleep, resulting in losses in the daily functioning of patients, such as lack     of attention, concentration and memory, fatigue, moodiness and irritability that are     potentially associated with changes in sleep architecture, especially the reduction in     slow-wave sleep. The most widely used therapy for the treatment of insomnia is the drug, but     currently the resistive exercise is an important non-pharmacological intervention known to     provide enough increase in slow wave sleep, and improve other parameters of sleep, as well as     reducing symptoms of anxiety that are directly associated with the framework of insomnia.     OBJECTIVE: To evaluate the effect of chronic resistive exercise in sleep patterns, the     profile of mood and quality of life of patients with chronic primary insomnia. METHODOLOGY:     30 patients will be selected (male and female) with chronic primary insomnia. (Clinical     diagnosis based on DSM-IV) referred for ambulatory sleep disorders Sleep Institute - AFIP.     The protocol will be conducted at the Center for Psychobiology and Exercise (CEPE) of the     AFIP and the Sleep Institute. Volunteers will be randomized into 2 groups of 15 participants,     which will hold a resistive exercise and the other stretching exercise. This study will     consist of three assessments: Pre-intervention (baseline), intermediate Rating (2 months) and     post-intervention (at the end of 4 months). In the program of resistive exercise will be held     48 sessions that involve upper and lower limbs, abdominal and paraspinal region. It will be     initially used a relative intensity 50% 1-RM. After 2 months of training intensity will be     increased to 60% of 1-RM. Each exercise will be conducted in three sets of 12 repetitions, at     intervals of 30 seconds between sets and one minute between each exercise. The total duration     of the training session will be approximately 50 minutes. Before starting the training,     participants will hold for 5 minutes stretching and warming on a bicycle ergometer (Life     Cycle 9100) or treadmill (Life Fitness 9100) for the same period. After the session, the     volunteers performed repeated stretches at the start of training. The group submitted to     follow the practice of stretching protocol performed by Tworoger et al. that consist of 48     sessions of stretching for 60 minutes of low intensity, three times a week. The session will     begin with 5 minutes of walking around the room, followed by 45 minutes of stretching     exercises that involve the upper and lower limbs, 8 to 10 types for each region and end with     10 minutes of relaxation. STATISTICAL ANALYSIS: The variables of sleep, body composition and     maximal repetition test will be analyzed using the software Statistica 7.0 (StaSoft, INC).     The appropriate statistical test, parametric or nonparametric, will be chosen according to     the data of the sample groups.   "
130940|NCT01571102|"     In this study we investigate whether physiotherapy offers added value in rehabilitation after     meniscectomy compared with no therapy or a home program. The population consists of 180     post-operative meniscus injury patients, operated at UZ Gent, the first 60 patients received     no therapy, the next 60 patients were offered a treatment by their home physiotherapist     according to our established protocol and the last 60 patients we have prepared a home     program .      The physiotherapeutic treatment has been prepared based on scientific literature and own     experience from the program at Ghent University and internships. It includes exercises to     promote mobility, strength and stability and exercises to reduce pain and swelling depending     on the phase of tissue repair and evolution of the patient. This schedule will be given to     the patient along with the questionnaires at registration of the operation and will serve as     a guideline for the physiotherapist for the rehabilitation of the patient after surgery.     Monitoring of the evolution will take place by calling the physiotherapist on regular basis.      The home program is prepared on the basis of commonly used home exercises after arthroscopy     and also includes exercises to promote mobility, strength and stability and exercises to     reduce pain and swelling. The difference with the physiotherapeutic treatment is that there     is no control and supervision of a physiotherapist and that the treatment is more limited.     This program is given with the patient along with the questionnaires at registration of the     operation.      Pre-operatively and 4 weeks, 3 months, 6 months and 12 months post-operatively, an evaluation     of the current condition of the patient will happen on the basis of standardized     questionnaires. Based on the results of these questionnaires, collected at different times,     we can determine which treatment provides the best rehabilitation after meniscectomy. The     first (preoperative) questionnaire, given at registration of the operation, is completed and     given to the nurse of the day hospital on the day of surgery, the other (postoperative)     questionnaires are sent electronically to the patient's email address and need to be     returned, after filling up.      This study spends specific attention to the speed of resumption of work / sports and daily     activities and the presence or absence of complaints.   "
130941|NCT01571089|"     The main interest in this study is to investigate if it is possible to use strategies from     Dialectical Behavior Therapy (DBT) to increase effectiveness of ordinary Cognitive Behavioral     Therapy (CBT) for patients with anxiety disorders. For the patients included in this study,     previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of     positive results after treatment).   "
130942|NCT01571076|"     Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal     embryos before the transfer in IVF treatments in many cases. There is great debate in the     scientific community as to whether this is an efficient practice in patients of different     prognosis.      This prospective and randomized study seeks to study the results of chromosomal diagnosis     using the new Comparative Genomic hybridization (CGH) arrays technique by practicing     Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not     on the other arm in order to compare the results. The investigators will study the ongoing     pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos     (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two     different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male     severe factor (≥2 million spermatozoids/ml.).   "
130943|NCT01571063|"     Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to     biochemical and histological parameters.        -  Trial with medicinal product   "
130944|NCT01571050|"     The risk of dental fluorosis development is related to the systemic exposure to fluoride     during enamel formation. Currently, diet and fluoride toothpastes are the main sources of     fluoride to children at the age-risk for fluorosis development. However, when estimating the     risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the     systemic fluoride bioavailability. Since some toothpaste formulations may contain part of     fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride     in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult     volunteers will ingest a standardized dose of total fluoride from commercially available     toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic     bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after     ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.   "
131578|NCT01562756|"     In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research     will conduct a pilot study for the purposes of testing equipment, finalizing data collection     protocol, and training study personnel before conducting the full-scale trial.   "
130945|NCT01571037|"     Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left     ventricular assist device (LVAD) implantation and has been shown to adversely affect     peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and     post-operatively are limited. Inhaled milrinone has been shown in several small human studies     to be safely tolerated and provide favorable effects on pulmonary hemodynamics.      Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may     provide pulmonary artery vasodilation and therefore improved RV function in patients with end     stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation or as     destination therapy.      Specifically, we aim to:        -  demonstrate safety of inhaled milrinone in this patient cohort        -  demonstrate efficacy of inhaled milrinone in this patient cohort   "
130946|NCT01571024|"     The purpose of this study is to establish the safety and tolerability of BKM120 when combined     with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in     advanced solid tumors including metastatic pancreatic cancer.   "
130947|NCT01571011|"     The purpose of the study is to determine whether a culturally tailored, low-cost, primary     care/internet based depression prevention intervention (CURB) is superior to wait-list     control for African American and Hispanic youth in terms of depression-related outcomes. It     is hypothesized that compared to teens in the wait-list control condition, teens in the CURB     program will exhibit lower levels of depressed mood and/or more rapid changes in mood during     the follow-up time.   "
130948|NCT01570998|"     This phase IV trial studies the side effects of intraoperative radiation therapy and how well     it works in treating patients with breast cancer undergoing breast-conserving surgery.     Delivering radiation one time to the area where the tumor was removed while the patient is     still in the operating room may kill any residual tumor cells and may be as effective as     standard radiation therapy in patients with early stage breast cancer.   "
130949|NCT01570985|"     This is a study on the treatment of frozen shoulder with injection of cortisone into the     shoulder joint. The purpose of the study is to evaluate whether injection with stretching of     the shoulder capsule or plain injection is more effective than no specific treatment.   "
130950|NCT01570972|"     Multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT] are     evidence-based treatments for first episode psychosis. However, like all treatments for     psychotic disorders, neither MFG nor GCBT are perfect—some individuals who receive these     interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms     through which these interventions produce their clinical benefits and identifying the factors     that may maximize an individual's response to MFG and GCBT could improve the clinical     benefits facilitated by these two interventions.   "
130951|NCT01570959|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.   "
130952|NCT01570946|"     Primary prevention of diabetes is of paramount importance in both developed and in developing     countries. Several studies including the Indian Diabetes Prevention Programmes have shown     that Lifestyle modification in people with prediabetes can reduce the progression to diabetes     by 58%. However, there are two main problems in applying diabetes prevention strategies to     the population as a whole. (1) Trial based interventions are unrealistic on a population     level in any country. (2) The oral glucose tolerance test applied so far to identify those at     high risk is a poorly reproducible and time consuming test both for the participant and for     health care workers. Hence more practical means of defining individuals who would benefit     from lifestyle intervention are required.      The current study proposes a prevention strategy that will employ a lifestyle modification     programme delivered by text messaging in both India and the UK.Subjects will be identified     based on the HbA1c measurement instead of the oral glucose tolerance test. The study will     also assess the efficacy, acceptability and cost effectiveness of mobile phone based     intervention both in India and the UK.      Messages will be based to deliver education, treatment targets, advice, support and     motivation. Subjects will be invited to participate and, once recruited, will be randomised     to usual care or the SMS intervention group.      Usual care will consist of a one-to-one 30 minute interview, conducted by the research team,     delivering personalised diet and exercise advice.      The intervention group will undergo the same initial interview and, in addition, will receive     3 times weekly text messaging with education, advice, support and motivation. These messages     will be personalised to individual targets set at the initial interview.      Primary Outcome:Progression to Diabetes Secondary Outcomes will be based on Physical activity     / Cardiovascular risk factors/and quality of life.      The study programme is compatible with major initiatives in both the UK and India for the     prevention of diabetes and cardiovascular disease (CVD).   "
130953|NCT01570933|"     Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require     non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal     interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows,     through an oesophageal catheter, to record the electrical activity of the diaphragm and     thereby synchronize breaths from the ventilator on the inspiratory efforts of the child.     Moreover, the pressure support delivered by the ventilator may be proportional to the     diaphragmatic effort developed by the child. This mode, associated with the interface     Miniflow®, could increase the comfort of the child by allowing a more efficient     synchronization and reducing its respiratory work. To our knowledge, this ventilation mode     with this interface has not been evaluated in the postoperative period of cardiac surgery in     the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory     mode and evaluate its influence on ventilatory parameters of this category of infants.   "
130954|NCT01570920|"     Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3     months. The physical training program was based on walking.   "
130955|NCT01570907|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Quetiapine Fumarate 25 mg Tablet under fasted conditions.   "
130956|NCT01570894|"     The objective of this study was to prove the bioequivalence of Roxane Laboratories'     Quetiapine Fumarate 25 mg Tablet under fed conditions.   "
130957|NCT01570881|"     Delirium is common complications in postoperative critically ill patients. However the     mechanism of postoperative delirium is not well understood.The investigators designed a     prospective observational study to investigate the association of perioperative plasma     melatonin levels with postoperative delirium and general anesthesia. The investigators     included 33 patients required intensive care more than 48 hours after sevoflurane anesthesia     in an academic tertiary care hospital. The investigators measured plasma melatonin levels 4     times and assessed postoperative delirium using Confusion Assessment Method for the intensive     care unit (CAM-ICU).   "
131033|NCT01569893|"     To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified,     centralized and large scale tele-monitoring of blood glucose levels, and whether this     intervention produces health and economic benefits when introduced without major changes to     the existing organization of a large treatment care center.   "
130958|NCT01570868|"     The goal of this clinical research study is to learn if ponatinib can help to control Chronic     Myeloid Leukemia (CML) in accelerated phase. The safety of this drug will also be studied.      Ponatinib is designed to block the function of BCR-ABL, which is the abnormal protein     responsible for causing leukemia in certain cells.      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or     death. A blood clot may occur within 2 weeks after you start taking the drug. About 25% (1 in     4) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that     do not have other known risk factors for forming clots. If you develop a blood clot, you will     need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the     clot and restore blood flow.   "
130959|NCT01570855|"     The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer     and determine the most effective treatment based on results of chemo sensitivity testing on     the patients own cancer cells in the laboratory. The results of this screening will not     influence the patients treatment.   "
130960|NCT01570842|"     Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity)     associated with an increase in acidic and non acidic reflux as well as systemic inflammation     involving esophageal mucosa, thereby increasing esophageal injury and predisposing to     subsequent development of Barrett's esophagus (BE)?   "
130961|NCT01570829|"     -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in          treatment of obese patients (BMI 35,0-39,9 kg/m2).        -  To assess clinical efficiency of Dietressa in the dose of 6 tablets daily within 24          weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).   "
130962|NCT01570816|"     The purpose of this research study is to evaluate the effectiveness of functional electrical     stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and     ankle function to improve walking in people with partial paralysis.   "
130963|NCT01570803|"     Recent stent design improvements focus on decreasing stent fracture rates which can     negatively impact patency rates by rearranging strut alignment. Although there have been     several retrospective or registry studies for atherosclerotic femoropopliteal disease in the     East, there have been few randomized control trial for comparison of stent fracture and     primary patency between different nitinol stents. Smart stent has the peak-to-valley bridge     and in-line interconnection. Medtronics company have claimed Complete's stent crowns have     been configured to minimize crown to crown interaction, increasing the stent's flexibility     without compromising radial strength. We made the hypothesis that the design of Complete-SE     stent might be more fracture-resistant or effective for in-stent restenosis, compared with     Smart stent. On the other hand, 2011 ESC guideline recommended that dual antiplatelet therapy     with aspirin and a thienopyridine for at least one month is recommended after infrainguinal     bare-metal-stent implantation. Recent meta-analysis has shown that the efficacy of cilostazol     in the atherosclerotic femoropopliteal lesion was proven. However, still specific data     regarding a variety of antiplatelet regimen are limited. To date, there is no the study for     comparison between clopidogrel and cilostazole in patient undergone stent implantation in     femoropopliteal lesion. In conclusion, the purpose of our study is to examine and compare     Primary patency and stent fracture between different two-nitinol stents (S.M.A.R.T. CONTROL     versus Complete SE) and to compare binary restenosis rate between clopidogrel and cilostazol     in femoropopliteal arterial lesion.   "
130964|NCT01570790|"     The purpose of the study is assess safety, bioactivity, and maximal tolerated dose of     repeated weekly intravenous infusion of combretastatin A-4 phosphate (CA4P) in patients with     neovascular age-related macular degeneration   "
130988|NCT01570478|"     The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler®     100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation     b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in     post-dose peripheral airway resistance) in patients with asthma.   "
130966|NCT01570764|"     By including in this study patients with significant worsening of their lung volumes and / or     their DLCO (carbon monoxide diffusing capacity) in the previous year, on the basis of an open     retrospective study we recently conducted, we hope to demonstrate that a strategy combining     prednisone and intravenous cyclophosphamide therapy is accompanied by an increase in the     frequency stabilization / improvement of lung volumes and / or DLCO of patients at 12 months     of 15% in the placebo and prednisone cyclophosphamide 50% in cyclophosphamide and     prednisone.We also hope to demonstrate significant decrease in the number of patients     excluded for failure in the CYC arm as compared to the placebo arm.   "
130967|NCT01570751|"     This trial is conducted in the United States of America (USA). The aim of the trial is to     confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in     controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.   "
130968|NCT01570738|"     Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem.     The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most     of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in     the age group of 6 and less and about 1.5% above. The in-lab sleep study using full     Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep     Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full     night PSG, together with long waiting lists for sleep studies, have led to the commonly used     procedure of split-night for OSAS patients, as well as to the development of a variety of     ambulatory sleep study systems. The primary study objective is to compare the efficacy of the     WatchPAT200 (WP200), as an ambulatory device for aiding in the diagnosis of sleep disorders     for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a gold     standard.   "
131034|NCT01569880|"     The purpose of the study is to investigate the relationship between hypoxemia achieved during     Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial blood     gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to study the     effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.   "
131035|NCT01569867|"     This study intends to investigate genetic influences on how individuals process statins.   "
130969|NCT01570725|"     Background. Preoperative anxiety is a common problem for patients who undergo surgical     operations, being often associated with a number of negative behaviours during and after the     surgical experience. Since drug treatments alone have frequently proved to be inadequate to     reduce stress and anxiety in surgical contexts, in the last decades there has been an     increased interest in non invasive complementary and alternative medical therapies (CAM),     including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension     during pre and post operative phases. Virtual reality can be considered an innovative form of     e-health-based CAM therapy having gained recognition as a means of attenuating pain during     medical procedures. VR reduces distress and pain perception by providing a particularly     intense form of immersive distraction that taxes the patient's limited attention capacity,     resulting in the withdrawal of attention from the real, noxious, external stimulus with a     subsequent reduction in pain and stress.      Objective. The aim of this study is to test the efficacy of a small, portable and immersive     virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory     surgical operations under local or regional anaesthesia.   "
130970|NCT01570712|"     As mental health care shifted from state psychiatric hospitals to the community in France and     western countries, the mental health system became inevitably involved in housing as it     strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers     found themselves unable to find stable living in the community and struggling with     addictions, they became a significant subgroup within a larger homeless population, which has     received increasing policy attention over the past three decades. There are two distinct     service models for adults who have severe mental illness and are homeless: the residential     continuum model and the Housing First model.   "
130971|NCT01570699|"     The main objective is to compare the genotypes of the COMT Val158Met polymorphism between     opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample     of opiate-users without any lifetime opiate dependence.   "
130972|NCT01570686|"     The purpose of this study is to evaluate the effect of food on aliskiren's efficacy,     pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light     meal versus fasted conditions.   "
130973|NCT01570673|"     What are we doing? A pilot research study is planned to take place within the Pediatric     Urology program at McMaster Children's hospital starting this spring/summer 2012. The pilot     study will compare standard individual teaching that occurs in pediatric urology clinic about     bladder re-training and achieving healthy bladder and bowel habits to a group teaching     session. The group teaching session will be one hour in length and include the same content     taught in pediatric urology clinic and provide more time for the children to ask questions,     demonstrate and practice different exercises and talk about some of the challenges associated     with having problems with their bladder. The group teaching session will be approximately one     hour in length and occur weekly in the evenings for 12 to 15 weeks. Study participants will     be asked to attend either one group teaching session or one individual teaching session which     will occur in regular pediatric urology clinic. Parents will be asked to complete a     demographics questionnaire at the start of the study and child participants will be asked to     complete 2 short questionnaires about symptoms and quality of life before and after either     individual or group teaching sessions. At the 3 month follow up, parents and child     participants will also be asked to fill out an evaluation form of the session received.     Children between the ages of 6 and 10 years old and a diagnosis of nonneurogenic lower     urinary tract dysfunction will be asked if they would like to participate.      Why are we doing it? Some of the symptoms of bladder dysfunction include incontinence     (wetting), recurrent urinary tract infections, frequency (having to pee a lot) and urgency     (having sudden urges to pee). These symptoms can affect a child's physical and     emotional/mental well-being. Treatment includes improving bladder habits through bladder     re-training and improving bowel habits through treatment and management of constipation as     well as establishing a bowel routine. Children are taught about their urinary tract system     and what they need to do to improve and maintain its health. Children are asked to void (pee)     every 2 hours, double void and drink more water. Sometimes they also need to take     medications. Often in a busy clinic, parents are taught what the child needs to do and     expected to return home and implement the bladder re-training instructions. Participation of     the child during these visits varies. However, participation and engagement of the child in     bladder re-training is crucial for success. Also, little time is spent on the impact of     bladder dysfunction on the lives of these children. Many children do not want to follow the     instructions on bladder re-training because they are worried about what their peers may say.      What do we hope to accomplish? The purpose of this study is to assess the feasibility of a     group teaching session and evaluate the preliminary effectiveness of the session.     Questionnaire results will be compared before and after the teaching sessions and between the     individual and group teaching groups. Evaluation forms will provide feedback about the     teaching sessions which will help determine the strengths of the sessions and improvements     that could be made to improve the quality and effectiveness of future treatment. Outcomes     that will be measured include symptoms and quality of life. This pilot study will also     provide important information related to symptoms and quality of life for these children.   "
130974|NCT01570660|"     Thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. Here the     investigators examined whether pioglitazone (PIO) improves insulin sensitivity independently     of glycemic control and whether adipokines or non-esterfied fatty acids (NEFA) serve as     mediators.   "
130975|NCT01570647|"     The purpose of this study is to develop a measure - the needle torque test - capable of     detecting connective tissue abnormalities associated with musculoskeletal disorders.   "
130976|NCT01570634|"     Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to     life-threatening colitis. Illness from C. difficile most commonly affects patients in     hospitals and long-term care facilities and typically occurs after a patient has received     antibiotics.      In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to     bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity     of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would     likely occur in conjunction with neutralization of C. difficile toxins A&B by CASAD. Computer     modeling of CASAD performed by Phillips et al. at Texas A&M University supports this     hypothesis.      The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care     therapy will reduce the duration and severity of diarrhea and other symptoms in patients with     C. difficile infection.   "
130989|NCT01570465|"     All patients receiving induction, consolidation and salvage chemotherapy, and autologous or     allogeneic stem cell transplantation according to a strategy defined in the GIMEMA AML1310     protocol will be prospectively monitored for SI (bacteremia, invasive mycoses, other     microbiologically documented bacterial infections, pneumonia, other invasive tissue     infections and viral diseases) during each chemotherapy and transplant and the impact of     these infections on survival will be evaluated until 24 months from the diagnosis of AML.   "
130977|NCT01570621|"     Achalasia is a rare esophageal motility disorder, characterized by incomplete lower     esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and     aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and     chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin     injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral     endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal     invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM     in our department, and to assess short-term and long-term efficacy of POEM by using Stooler     score, Echardt score, esophageal barium and manometry.   "
130978|NCT01570608|"     Ranibizumab has been proven to be effective in large multicentre studies. However, the     injections have to be repeated monthly. A combined therapy with the established photodynamic     therapy might even be more effective, less intravitreal injections might be necessary due to     a synergistic effect.      The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in     combination with verteporfin photodynamic therapy under a new time regime is an effective,     safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV)     secondary to Age-Related Macular Degeneration (AMD).   "
130979|NCT01570595|"     The purpose of this study is to evaluate the first web-based cessation program developed     expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate     the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2)     to complete a prospective, randomized controlled trial comparing the efficacy of the online     program to standard care with a primary outcome of 3 month point-prevalence abstinence.   "
130980|NCT01570582|"     purpose Primary endpoint        -  To evaluate the 24 month disease free survival Second endpoints        -  To evaluate the 24 month overall survival To analyze the toxicity and the quality of          life   "
130981|NCT01570569|"     The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate     potential drug-drug interactions associated with use of a cocktail of caffeine, losartan,     omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9,     CYP2C19, CYP2D6, and CYP3A activities.   "
131000|NCT01570322|"     Study the factors that explain Health-Related Quality of Life (HRQL) in patients with     Alzheimer disease including:        -  The influence of the environment (physical and human) on Health-Related Quality of Life          (HRQL),        -  The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),        -  The influence of formal and informal help mobilized,        -  The influence of interactions patient - caregiver on Health-Related Quality of Life          (HRQL),        -  The influence of the ratio necessary cost on available resources on Health-Related          Quality of Life (HRQL)   "
130982|NCT01570556|"     When considering occult infections during the diagnostic workup of inflammation in     Hemodialysis (HD) patients, the urine-deprived bladder is frequently dismissed as potential     site of infection. The urinary tract, even in end stage renal disease (ESRD) patients on     hemodialysis may represent a significant reservoir for infection. Delayed diagnosis is a     relevant issue because the urinary tract is often overlooked as a source of infection in     dialysis patients, especially because of absence of urinary tract infection (UTI) symptoms in     HD patients. Contributing factors to asymptomatic UTI in HD patients include the presence of     low urine volume, bladder stasis, and the fact that UTI symptoms are mostly related to     voiding, which is reduced or absent in these patients. Persistence of asymptomatic     bacteriuria and UTI may be related to higher levels of inflammatory markers in HD population.     In view of the association between cardiovascular disease and cardio-vascular and all-cause     mortality with inflammation, as expressed by elevated CRP and/or IL-6 levels in HD patients,     the investigators questioned whether presence of asymptomatic UTI could contribute to     elevated levels of inflammatory markers in patients with ESRD on maintenance HD therapy. Such     a finding would provide a potential link between a treatable infection and a potential     cardiovascular risk factor in this population.   "
130983|NCT01570543|"     The purpose of the study is to improve image quality, increase speed of scanning and to see     how well certain products test by scanning people who have an orthopedic hip or knee metallic     implant.   "
130984|NCT01570530|"     The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both     during preoperative and postoperative period), as prophylaxis against postoperative atrial     fibrillation after cardiac surgery, in a valve disease patient population (with or without     associated coronary artery disease), with no previous history of atrial fibrillation and not     receiving beta-blocking drugs.   "
130985|NCT01570517|"     The purpose of this study is to evaluate the safety and potential benefits of the interatrial     septal defect (IASD) System in patients with heart failure with preserved ejection fraction.   "
130986|NCT01570504|"     Ivermectin is currently the best drug to cure strongyloidiasis, but the standard single     dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal     in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the     parasite.      Aim of this study is to define the most effective dose schedule of ivermectin to cure     strongyloidiasis.   "
130987|NCT01570491|"     No sample size estimation methodology currently exists for the right-censored count data     models. We expect less number of attempts in the ultrasound group a 20 % difference between     the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level     of significance with a power of 0.8, we will require a minimum of 20 patients per     group,therefore we plan to recruit 40 patients in total. Patients who consent to receive     spinal anesthesia (as opposed to some other anesthetic technique) and who meet the     inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery     after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia     technique. A block randomization scheme with random block sizes ranging from 2-8 patients     will be used. The outcomes will be recorded by a third party observer in the block     room/operating room who might be a nurse or resident or clinical research fellow not directly     involved with performing the block. The post procedure outcomes will also be recorded by a     clinical research fellow or resident who was not directly involved with performing the block.     The analysis will be conducted by a statistician who will be blinded.   "
130990|NCT01570452|"     Matrix metalloproteinases (MMPs) have been shown to be involved in cancer biology.     Significant expression of MMP-7 (matrilysin) in colorectal cancer is mainly associated with     metastatic disease even though it is expressed in most tumor states. Our purpose is to     analyse MMP-7 in bowel and lymph nodes of different tumor stages and to evaluate its     expression as a potential biomarker of cancer disease in patients surgically treated for     benign and malignant colorectal tumors. Tumoral tissue, lymph nodes and serum samples from     recruited Patients plus serum samples from healthy volunteers are analysed for matrilysin     expression by histology, immunohistochemistry, ELISA and Western blotting.      If Matrilysin increases with increasing dysplasia and cancer disease stage in tumor tissue as     well as in the regional lymph nodes it might be used as a complement in investigating     suspected locally advanced cancer.   "
131001|NCT01570309|"     Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular     disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and     prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living     populations in the United States especially in urban, and multi-ethnic low income Northern     cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk     and evaluate outcomes have not been performed.      The investigators propose a double-blind, randomized wait-list control trial in subjects with     Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is     to measure endothelial function using reactive hyperemia peripheral arterial tonometry     (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to     measure levels of inflammation before and after treatment with Vit D replacement therapy.     These aims will test the hypotheses that Vit D repletion will improve endothelial function     and reduce the levels of detectable inflammation in the plasma of these subjects.   "
131002|NCT01570296|"     The safety, tolerability and recommended phase 2 dose (RP2D) of the combination of gefitinib     and BKM120 will be determined.   "
130991|NCT01570439|"     Aim: To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens     (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.      Methods: The panel of candidate peptides are synthesized and tested for their ability to     induce peptide-specific CTL responses, in order to screen the peptide epitopes applicable for     the cancer vaccination. Briefly, peripheral blood lymphocytes (PBLs) derived from     HLA-A1101(+) healthy donors are taken and cultured in the presence of the each candidate     peptide with recombinant IL-2 for 2 weeks, and then, re-stimulated with dendritic cell pulsed     with the peptide following another 2 week culture. Thereafter, CD8(+) T lymphocytes were     negatively selected with CD4-magnetic beads from cultured lymphocytes and tested for their     peptide specificity employing enzyme-linked immunospot (ELISPOT) assay. These conditions are     completely performed in in-vitro system. Importance in medicine: If one could identify the     peptide epitopes from novel Oncoantigens, it is applicable for clinical trials of cancer     vaccination.      Benefits & Risks : There is no risk except for the matter of venipuncture in each     individuals.      The ideal target molecules for cancer vaccination are thought to be selectively expressed in     tumor cells, but not in the normal cells, with high frequent and homogenous expression within     tumor. We have proved that novel Oncoantigens, URLC10, KIF20A and CDCA1, have these     characters as ideal target molecules for the cancer vaccination and are highly expressed in a     variety of tumor type such as gastric, lung, and pancreas cancer. Since HLA-A1101 haplotype     is most frequent in Singaporean, it is essential to indentify the HLA-A1101-restriced     peptides derived from these Oncoantigens to develop cancer vaccination.   "
130992|NCT01570426|"     The purpose of this research is to learn more about how children with mental health problems,     including bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD), and     generalized anxiety disorder (GAD), differ from children without these problems. The     investigators want to understand how these 4 groups of children differ in brain activity,     function, and structure.   "
130993|NCT01570413|"     This study is designed to determine whether the pelvic examination (including bimanual and     speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower     abdominal pain when an intra-uterine pregnancy (IUP) is seen on ultrasound. Patients with the     chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and positive     HCG will be considered for this non-inferiority-designed clinical trial. All patients who     present to the BMC Emergency Department (ED) Mon - Fri from 8am to 11pm and have had serum or     urine HCG testing and a formal ultrasound by a credentialed emergency physician or radiology     technician as part of standard of care will be screened for further eligibility. Those     patients with intra-uterine pregnancies < 16 weeks gestation seen on ultrasound and meet     inclusion criteria will then be asked to provide informed consent to participate in the     study. Randomization will occur after consent has been obtained. Half of the patients will be     randomized to receive pelvic examinations and the other half will not. Further care will be     determined by the treating attending physician. The primary outcome will be a composite     morbidity endpoint at 30 days, including return visits to the ED, emergency surgery, need for     transfusion, infection, or other missed source of bleeding/ pain. Secondary outcomes of     interest include ED throughput time, and patient satisfaction.   "
130994|NCT01570400|"     The purpose of this study is to determine whether an internet-based treatment program,     consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces     symptoms of social phobia among a population diagnosed with this disorder.   "
130995|NCT01570387|"     This study seeks to enroll patients with AL amyloidosis, for whom treatment with one of the     standard melphalan chemotherapy-based regimens is either not recommended or is not their     preference.      Pomalidomide (CC-4047) is a drug given by mouth, which can change or regulate the functioning     of the immune system. So, in theory, it may reduce or prevent the production of the amyloid     protein. Pomalidomide is not currently FDA-approved for AL Amyloidosis. Pomalidomide is     chemically similar to thalidomide and lenalidomide, both of these drugs have been approved by     the FDA for treatment of patients with multiple myeloma (MM), a disease similar to AL     Amyloidosis.      Participants in this study will receive pomalidomide and dexamethasone. Phase I is a     dose-escalation study and dose escalation will proceed through 3 dose-levels according to     standard rules in which dose levels are started sequentially after complete evaluation of the     occurrence of dose-limiting toxicities. In the Phase II portion, participants will receive     pomalidomide and dexamethasone using the defined maximum tolerated dose.   "
130997|NCT01570361|"     The objective of this study is to determine whether early radiofrequency (RF) ablation     treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including     THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation     (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate     or rhythm control) using current AF management guidelines.   "
130998|NCT01570348|"     This phase II trial studies how well giving a donor bone marrow transplant (BMT) works in     treating patients with refractory Crohn's Disease. We will select patients with severe     Crohn's Disease and active inflammation despite the best medical and surgical treatments.     These patients must be healthy enough to undergo a transplantation procedure. They cannot     have an active infection, and their heart, lungs, kidneys, and liver cannot be failing. The     transplant procedure starts with chemotherapy and a small dose of radiation, to weaken a     patient's immune system so that it will accept bone marrow cells from another person. After     that other person's bone marrow cells are given to the patient, immune suppressive medicines     are given to prevent the new cells from being rejected and to stop those cells from damaging     the patient. After the new donor cells start to work, blood counts will rise and the new     immune system will start to grow. During this time, there is a risk of infection. Antibiotics     and anti-viral drugs will be given to prevent infection. When the new donor cells are     well-established, immune suppressive medicines are discontinued. We will examine parts of the     intestine that were inflamed before the start of the transplant procedure, to be sure the     Crohn's Disease has disappeared after the transplant. Patients will be formally evaluated for     Crohn's activity at around 100 days after transplant, and yearly after that for 5 years.   "
130999|NCT01570335|"     The aim of this study is to analyze the impact of SBAR by the SAQ questionnaire in the     perinatal department.   "
131003|NCT01570283|"     The subjects eligible for this trial have a type of blood cell cancer, other blood disease or     a genetic disease for which they will receive a stem cell transplant. The donor of the stem     cells will be either the subject's brother or sister, or another relative, or a closely     matched unrelated donor. The Investigators are asking subjects to participate in this study     which tests if blood cells from the subject's donor that have been grown in a special way,     can prevent or be a effective treatment for early infection by five viruses - Epstein Barr     virus (EBV), cytomegalovirus (CMV), adenovirus, BK virus (BKV) and human herpes virus 6     (HHV6).      Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious     life-threatening infections in patients who have weak immune systems. It can affect the lungs     and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.      CMV can also cause serious infections in patients with weak or suppressed immune systems. It     usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut,     the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body.     In healthy people CMV rarely causes any problems because the immune system can keep it under     control, but after a transplant, the risk of developing CMV disease is much higher because     the immune system is so weak.      EBV is the virus that causes glandular fever or kissing disease. It is also a life long     infection like CMV that is normally controlled by immune system. When immunity is weak, the     virus can become active and cause fevers, enlarged lymph nodes and sometimes a type of cancer     called lymphoma.      BKV is a virus that usually causes symptoms of a common cold such as fever and normally does     not cause problems. If the immune system is weakened in some way, for example following a     bone marrow transplant, then BKV can cause life-threatening infections affecting mainly the     kidneys, bladder, and urinary tract.      HHV6 is another virus that infects most people in childhood causing symptoms like fever,     diarrhea and rash. Like CMV, EBV, and BKV, HHV6 remains in the body for life and can cause     problems when the immune system is weakened. When this occurs the virus can affect many     organs including the brain, lungs, heart, kidney and gastrointestinal tract.      The Investigators want to see if they can use a kind of white blood cell called T lymphocytes     (or T cells) to prevent and treat adenovirus, CMV, EBV, BKV and HHV6 in the early stages of     reactivation or infection.      The Investigators have grown T cells from the subject's stem cell donor in the laboratory in     a way that will train them to recognize the viruses and control them when the T cells are     given after a transplant. This treatment with specially trained T cells (also called     cytotoxic T cells or CTLs) has had activity against three of these viruses (CMV, EBV and     Adenovirus) in previous studies. In this study the Investigators want to see if they increase     the number of viruses that can be targeted to include BKV and HHV6 using a simple and fast     approach to make the cells.   "
131004|NCT01570270|"     In this study the investigators aimed at verifying whether consumption of a sheep cheese,     naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic     acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild     hypercholesterolemic subjects.   "
131005|NCT01570257|"     In treating idiopathic normal pressure hydrocephalus with a shunt there is always a risk of     underdrainage or overdrainage. The hypothesis is tested whether treatment of patients with an     adjustable valve preset at the highest opening pressure (OPV), leads to comparable clinical     results with less subdural effusions than in a control group with an opening pressure preset     and kept fixed at a low pressure level.   "
131006|NCT01570244|"     This study will investigate possible effect of multiple oral doses of BI 201335 on the steady     state pharmacokinetics of ethinylestradiol and levonogestrel   "
131007|NCT01570231|"     Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the     heart. This study aims to evaluate the feasibility, safety and initial efficacy of using     briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in     octogenarians with symptomatic intracranial arterial stenosis.   "
131008|NCT01570218|"     OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer     in patients with breast's or gynecology's cancer, during the radiotherapy treatment.   "
131009|NCT01570205|"     The objective of the study is to investigate safety, tolerability, and pharmacokinetics of     XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to     healthy male volunteers   "
131010|NCT01570192|"     The primary objective of this study is to demonstrate a low rate of emergence of antibiotic     resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized     patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem     administered as a prolonged infusion in combination with a parenteral aminoglycoside plus     tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 -     control arm).   "
131011|NCT01570179|"     Should the dose of sugammadex in morbid obese patients be calculated on the real body weight     or the ideal body weight?      The main objective of the trial is to compare in patients undergoing bariatric surgery the     efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on     real body weight (control intervention) with dosing based on ideal body weight (experimental     intervention). The research hypothesis is that both dosing regimens are equivalent      The secondary objective of the trial is to compare the impact of the depth of neuromuscular     blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very     deep block (TOF count = 0 and PTC < 5)   "
131113|NCT01568853|"     The role of complement system in bridging innate and adaptive immunity has been confirmed in     various invasive pathogens. The aim of this study is to investigate the alteration of     complement C3 in patients with severe abdominal sepsis and evaluate the role of complement C3     depletion in prognosis of such patients. The relationship between complement C3 depletion and     adaptive immunity is studied meanwhile.   "
131012|NCT01570166|"     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial     hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence     of HCC after partial hepatectomy is common and was reported to be more than 77% within 5     years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC     recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after     initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a     small proportion of patients with HCC recurrence (10.4-31%), either because of the poor     functional liver reserve or because of widespread intrahepatic recurrence. In the past two     decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality     and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0     cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year     survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is     particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors     are usually detected when they are small and PRFA causes the least deterioration of liver     function in the patients. To the best of our knowledge, there has been no report published in     the medical literature comparing the efficacy of repeat hepatectomy with PRFA for recurrent     HCC. The aim of this retrospective study is to compare the outcome of repeat hepatectomy with     PRFA for small recurrent HCC after partial hepatectomy.   "
131013|NCT01570153|"     The purpose of this study is to evaluate the ability of a non-invasive monitor that measures     how much fluid is in the body as well as various blood tests for their ability to predict     worsening kidney function in patients with heart failure.   "
131023|NCT01570023|"     This study is a multisite, randomized clinical trial to determine the effectiveness of an     8-week rehabilitative exercise regime performed by patients with swallowing problems, termed     dysphagia, compared to a control group of patients with swallowing problems who do not     exercise, but receive standard clinical care. One hundred male and female patients will take     part in this study from eight participating facilities around the country.   "
131036|NCT01569854|"     The study intends to investigate whether genetics influence how individuals respond to     statins (clinical outcomes and changes in carotid intimal media thickness)   "
131014|NCT01570140|"     Rationale: Accounting for the growth, aging and detrimental life style changes in the Dutch     population, the investigators expect further growth of number of known diabetes patients. The     economic burden with this increase will be enormous, the healthcare system is under     increasing pressure to provide better but more time efficient service to more people with     limited human resources. the investigators hypothesize that, by increasing the patients     self-management by offering remote care services, this reduction of the individual caseload     can be achieved.      Objective: Primary objective is to test the hypothesis that the consistent use of a web     portal and its educational content and the possibility to review personal diabetes related     data for type 2 diabetes patients (T2DM) in the primary care setting, will result in an     improvement quality of life.      Study design and methods: In this Prospective observational cohort study the investigators     examine the effect of the voluntarily use of a web portal and its educational content. The     primary end point is health related quality of life. We predefined a clinically relevant     difference of 0.074 in the EQ-5D index score. Secondary endpoints are diabetes-related     distress and well being and a selection of clinical measurements, number of contacts with     health care provider and the amount of prescribed medication. The participants are being     followed for 1-year and the data will be collected at baseline, after 6 months and 12 months.   "
131015|NCT01570127|"     The purpose of this study is to determine whether acupuncture treatment(Individualized &     Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment)     and also whether individualized acupuncture is more effective than standardized acupuncture.   "
131016|NCT01570114|"     Self-expanding metallic stent placement is a safe and effective endoscopic procedure     increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and     plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and     tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages     over non-covered stents, including the possibility of retrieval and limited local tissue     reaction, while providing alleviation of obstruction at possibly lower costs. Only few     reports of fully covered metal stent placement in patients with benign colorectal strictures     are available in the literature. The aim of this study was to assess the effectiveness of     FCSEMS in the management of the colonic benign strictures.   "
131017|NCT01570101|"     The primary objective for this clinical study is to assess the role of the CE Marked Sapheon     Closure System in closure of incompetent great saphenous veins GSV in a routine clinical     setting.   "
131018|NCT01570088|"     Folic acid is the synthetic form of vitamin folate. Because of its high stability and     bioavailability, it is the form of folate added to bread in Canada to reduce birth defects.     There are health concerns about long-term folic acid consumption. Another form of folate,     L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these     health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators     have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a     randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic     acid.      The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell     folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.   "
131028|NCT01569958|"     Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by     progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons,     the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal     chord), control voluntary movement. Riluzole, the only drug approved for ALS treatment,     modestly slow disease progression.      Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuromodulation     that is currently studied as a possible therapeutic tool for several neurological and     psychiatric diseases and has been found safe and well tolerated. Based on experimental     evidence in animals and human subjects, tDCS is expected to reduce motor cortex excitability     and excitotoxicity, that is neuronal injury induced by excessive glutamatergic stimulation,     one of postulated pathophysiological mechanisms in ALS.      This study will investigate if transcranial direct current stimulation of motor cortex is     useful in delaying disease progression and is well tolerated in ALS patients.   "
131019|NCT01570075|"     Hepatocellular carcinoma (HCC) is a common cancer, and it is the third commonest global cause     of cancer-related death. With an increase in life-expectancy of the general population, the     number of elderly with HCC is expected to increase. Current curative treatment options for     HCC include: liver transplantation, liver resection (LR) and local ablation therapy. Liver     transplantation is a good treatment for HCC within the Milan criteria (single HCC ≤ 5 cm or     up to 3 nodules each < 3 cm). As a consequence of the lack of liver donors, one relative     contraindication for liver transplantation is age over 65 years, or the protocol requires     elderly patients to have very good general health before they can be put on a transplant     list. Transcatheter arterial chemoembolization (TACE) is used more commonly for the treatment     of intermediate and advanced-staged HCC, while liver resection and local ablation therapy are     used for early-staged HCC. Amongst the local ablative therapies, radiofrequency ablation     (RFA) is most widely used. It has the advantage of minimally invasiveness, making it the     first-line treatment for small HCC in patients with compromised liver function or associated     severe medical conditions.      Elderly patients are more likely to have poor general conditions and associated medical     diseases. RFA has the advantage of being less invasive and it causes less pain, less blood     loss and earlier recovery than LR. On the other hand, incomplete ablation of HCC and tumor     track seeding may happen. Several studies have demonstrated the safety of LR for elderly     patients. There is no good evidence in the medical literature to support whether RFA or LR is     a better treatment for elderly patients with HCC.   "
131020|NCT01570062|"     This study is focused on the effects of HEPA filtration to reduce exposures to     combustion-derived air pollution (CDAP). Specifically, the study will evaluate the health     benefits of HEPA filters and compare the cardiovascular toxicity of two major sources of     CDAP, specifically traffic and residential wood combustion.      Specifically, the purpose of this study is to evaluate the ability of portable high     efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and air pollution indoors     and to improve subclinical indicators of microvascular function and systemic inflammation     among healthy adult participants.      The investigators hypothesize that HEPA filter use will help decrease indoor concentrations     of CDAP thereby helping to mitigate the associated cardiovascular risks.   "
131021|NCT01570049|"     The purpose of this study is to determine whether bendamustine HCl for injection is safe and     effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.   "
131022|NCT01570036|"     The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled     Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony     stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target study population is     node-positive (NP) (or node-negative [NN] if negative for both ER and PR) breast cancer     patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care     therapy. Disease-free subjects after standard of care multi-modality therapy will be screened     and HLA-typed. E75 is a CD8-eliciting peptide vaccine that was restricted to HLA-A2+ or     HLA-A3+ patients (approximately two-thirds of the US population), and has been extended to     HLA-A24+ and HLA-A26+ as well.   "
131025|NCT01569997|"     Introduction: Epidemiological data show that in France only half of patients with Alzheimer     disease are currently diagnosed in the general population. The absence of early diagnosis of     dementia reduces the opportunities of patients to receive optimal care. One of the     consequences of undiagnosed dementia is inadequate use of emergency care units.      The main objective: The main aim of this study is to evaluate the impact of a systematic     case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of     hospitalization in emergency care units.      Secondary objectives:      To assess the impact of systematic tracking of dementia cases on the:        -  Quantity and quality of drug-prescription        -  Appropriateness of hospitalizations        -  Prevalence of neuropsychiatric symptoms        -  Dependency        -  Quality of life        -  Burden of nursing staff working conditions        -  Planning of specific therapeutic measures        -  Overall health care costs   "
131026|NCT01569984|"     This is a single-centre, single-arm open-label proof-of-concept study to analyze the imaging     (DCE-CT,CEUS and Quantitative US) effects of neoadjuvant bevacizumab and SBRT on colorectal     metastases to the liver. Patients will receive 2 doses of bevacizumab 5mg/kg IV prior to     SBRT. The second dose of bevacizumab will be given 2 weeks after the first dose of     bevacizumab and within 48 hours of starting the first dose of SBRT. The SBRT prescription     dose will be up to 60 Gy in 6 fractions, delivered on alternating weekdays for 2 weeks. Total     SBRT dose will be determined by size of target lesion, liver sparing and organs-at-risk dose     constraints. DCE-CT, CEUS and Quantitative US will be performed within 7 days prior to the     first dose of bevacizumab, after the second dose of bevacizumab and within 7 days of     completing SBRT.   "
131027|NCT01569971|"     Sickle cell disease (SCD) is a debilitating genetic disorder affecting 70,000-100,000     Americans. It is frequently associated with very serious medical complications. For children     with SCD, successfully transitioning to adult care is a vital step in ensuring continuity of     care, managing their disease, and improving their health outcomes. Transition programs have     been created to facilitate the transition process. However, few studies have assessed     transition readiness and whether transition program components meet the transition needs of     patients and families.      The purpose of this study is to explore transitioning from pediatric care to adult care and     to assess components of the SJCRH SCD Transition Program from three perspectives: adolescents     with SCD, their caregivers, and young adults with SCD who have transitioned to adult care.     Data collection methods will include focus groups, questionnaires, and checklists.     Qualitative data analysis procedures will be used to examine the data.   "
131029|NCT01569945|"     What is the best medication for hormonal stimulation in cycles with high intra-uterine     insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days)     or daily injections with Human Menopausal Gonadotropin (Menopur)?   "
131114|NCT01568840|"     The purpose of this study is to assess the effectiveness of global postural reeducation     relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.   "
131115|NCT01568827|"     Pilot study to determine whether daily consumption of blackraspberry powder (high in     polyphenols) can reduce markers of inflammation and to determine whether genetics influence     baseline levels of inflammatory markers as well as individual's response to polyphenols. A     total of 10 males participated in this cross-over study.   "
131030|NCT01569932|"     This study will document the cognitive (mental) and functional abilities of newly diagnosed     cancer patients. The study will also examine the changes in cognitive and functional     abilities during and after chemotherapy (your cancer treatment).      A comprehensive set of questionnaires and tasks, or assessments, have been put together in     order for doctors and nurses to learn more about the day to day functioning of newly     diagnosed adult cancer patients. The investigators would also like to follow up with the same     adult patients, during and following completion of their cancer treatment, to learn about the     kinds of treatments they received and how their cognitive status and level of participation     in activities of daily living has changed. With follow-up assessments, doctors and nurses can     learn more about the complications or health problems that adult patients may experience as a     result of undergoing cancer therapy. This is a study involving two visits. The first visit     occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The     second visit occurs within two weeks of completing your chemotherapy.   "
131031|NCT01569919|"     This study is for patients with malignant mesothelioma of the lung lining (called pleura) who     are planning to have pemetrexed-cisplatin chemotherapy.      We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin     chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This     vaccine has been used in combination with chemotherapy in other types of cancer and has been     shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the     disease, in a similar way to the immune system fighting infection. In laboratory experiments,     the vaccine has been shown to stimulate an immune response to a particular protein widely     found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the     vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4     protein.      Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with     mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the     combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy     alone.      Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The     TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3     weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks.     Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the     planned trial schedule. We aim to recruit 26 patients into the trial over a two year period.     If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe     and beneficial in terms of stimulating the immune system, the combination will be tested     further in larger clinical trials.   "
131041|NCT01569789|"     The autonomic (self-regulating) nervous system is important for the function of many organs     in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve carries     incoming information from the nervous system to the brain, providing information about what     the body is doing, and it also transmits outgoing information which governs a range of reflex     responses. It plays an important role in the immune system. A part of the vagus nerve is     reachable for stimulation at specific locations in the ear.      The purpose of this study is to better understand how different ways of stimulating the vagus     nerve at the ear can affect a chemical marker of inflammation found in human blood that is     associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus.     This information may lead to in future studies to see if stimulation of the vagus nerve can     improve inflammation in chronic inflammatory diseases.   "
131042|NCT01569776|"     The primary objective of this clinical trial is to determine whether a new amino acid-based     formula is hypoallergenic as defined by the American Academy of Pediatrics (2000),     demonstrating that the test formula does not provoke allergenic activity in 90% of infants or     children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a     commercially available hypoallergenic formula.   "
131043|NCT01569763|"     The primary objective of this study is to evaluate the safety and effectiveness of the Aurora     Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in     reducing menstrual blood loss at 12 months post-treatment.   "
131044|NCT01569750|"     The purpose of this study is to identify if, and at what dose, ibrutinib may be administered     with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to     document responses of this combination in patients with newly diagnosed diffuse large B-cell     lymphoma (DLBCL).   "
131045|NCT01569737|"     The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies     exposed to ella, whether due to failure of the emergency contraception or inadvertent     exposure during pregnancy.   "
131046|NCT01569724|"     Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell     lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not     well known. The purpose of this study is to research a carbohydrate metabolism disorder     associated in bexarotene-induced hypertriglyceridemia.   "
131047|NCT01569711|"     Depression is a common, recurrent and disabling disorder. Among patients with a chronic     course of the disease, 20 to 30% are resistant to antidepressant medications. Among those     patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep     brain stimulation (DBS) of nucleus accumbens is considered.   "
131048|NCT01569698|"     Limited prospective data is available to compare morbidity and mortality between renal     replacement modalities in pediatric acute renal failure.      In the absence of clear standard of care, the choice of the extra renal replacement therapy     modality is subject to clinical judgement, practical aspects, and costs.      This study will supply important data about usual modalities of pediatric acute extra renal     replacement therapy and their impact on patient outcome and renal recovery. An obvious next     step will be to conduct a randomized controlled trial comparing the different strategies.   "
131116|NCT01568814|"     Morning only low volume PEG with low reside meals may enhance patient tolerability and have     similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG     with standard diet.   "
131200|NCT01567722|"     RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related     malignancies.   "
131049|NCT01569685|"     Background: The treatment of traumatised refugees is one of the areas within the field of     psychiatry with the weakest evidence for the different types of treatment. This is a problem     for both patients and doctors as well as for society.      The treatment of choice today for Post Traumatic Stress disorder (PTSD) is antidepressants     from the subgroup of Selektive Serotonin Reuptake Inhibitors (SSRI), among these the drug     Sertraline. The evidence for the use of these drugs as treatment for chronically complex PTSD     in traumatised refugees is however very limited and a large part of the group is estimated to     be insufficiently treated with this type of medicine. Venlafaxine is an antidepressant from     the subgroup of dual action product which means that is works on several pathways in the     brain. Among others it influences the area in the brain that is responsible for the enhanced     anxiety and hyperarousal experienced by traumatised refugees and which is found to be     enlarged among patients suffering from PTSD.      All together there is not sufficient evidence to conclude which type of medical and     psychological treatment that is most efficient when it comes to the treatment of traumatised     refugees. Also there is a lack of studies which examines social functioning and the relation     between psychosocial resources and outcome from treatment. Furthermore there is a lack of     knowledge of predictors of treatment outcome for the individual patients. This study seeks to     produce some of this evidence.      Method: This study is expected to include approximately 150 patients randomised into two     different groups. The patients are treated with Setraline or Venlafaxine depending on the     group the randomised to. Patients in both groups are getting the same version of manual based     Cognitive Behavioural Therapy that is specially adapted to this group of patients. The     treatment period is 6-7 month. The trial endpoints are PTSD-and depression symptoms and     social functioning all measured on internationally validated ratings scales.      Furthermore the study will examine the relation between expected outcome of treatment from a     range of predictors and the actual treatment results for the individual patient.      Results: Altogether this study will bring forward new standards for clinical evaluation and     treatment of traumatised refugees and the results are expected to be used in reference     programmes/clinical guidelines.   "
131050|NCT01569672|"     The Ohio Patient Navigator Research Program (OPNRP) proposes to alleviate disparities in     relation to the timely diagnosis and treatment of breast, cervical and colorectal cancer in     Columbus, OH.   "
131051|NCT01569659|"     The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a     standard dose of lurasidone in patients with treatment resistant schizophrenia or     schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of     positive symptoms and other components of psychopathology (negative symptoms, general     psychopathology, anxiety, depression, cognitive function, global function, severity of     illness and tolerability). Patients must qualify for treatment resistance after two or more     antipsychotic drug trials to be included in this trial.   "
131052|NCT01569646|"     Increased white blood cell count at the onset of an acute ST elevation myocardial infarction     has been shown to be associated of increased incidence of heart failure and mortality. Now     monocytes which are a subset of white blood cells may have a prognostic value for patients     presenting with acute ST segment elevation myocardial infarction. A monocyte count of greater     than 800/mm3 following acute myocardial infarction has been shown to be associated with     increased incidence of left ventricular dysfunction. The investigators study would     retrospectively collect data on patients with ST elevation myocardial infarction, looking for     an association between high monocyte count and the culprit vessel causing the myocardial     infarction. The investigators would also investigate whether monocytosis would be a marker of     poor prognosis.   "
131069|NCT01569425|"     In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance     and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not     required in lean PCOS patients; nevertheless, the influence of meal timing and composition on     glucose metabolism and hyperandrogenism may have clinical value. In this study the     investigators investigate the effects of two isocaloric diets with different meal timing     distribution on insulin resistance and hyperandrogenism in lean PCOS patients.   "
131053|NCT01569633|"     Objective of this study are:      1) To determine if medication help extreme preterm infants to tolerate feeding better by     reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1)     Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to study     after parental consent. Infant would be blinded to care givers. Infants will be randomized to     receive one of three medication for 7-14 days. If infants fail on one medication they will be     allowed to crossover to other medication. Infant would be allowed to treat like other     infants. Blindness can be broken if deem necessary by attending neonatologist.   "
131054|NCT01569620|"     The proposed study seeks to investigate the impact of a culturally targeted print educational     intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics.     If, as expected, the addition of culturally targeted materials to best clinical practices as     compared to a) best clinical practices plus standard materials or b) best clinical practices     alone leads to higher rates of CRC screening via colonoscopy then the culturally targeted     print educational materials can be easily disseminated among this rapidly growing minority     group who have low rates of CRC screening and whose disease is detected at later, less     curable stages.   "
131055|NCT01569607|"     Stroke is a leading cause of morbidity in the U.S. but identification of treatment strategies     to improve outcome is limited by the incomplete understanding of the mechanisms of recovery.     M1 reorganization plays a major-role in the recovery of motor deficits post-stroke; hence the     importance for further development of rehabilitative strategies that utilize this potential     for recovery. Non-invasive cortical stimulation can enhance the beneficial effects of motor     training on performance and functional plasticity of motor cortex. Among the different     approaches used in these studies, Hebbian-type M1 stimulation is particularly intriguing, as     it seems to be more effective when compared to random M1 stimulation. There is emerging     evidence that motor training or cortical stimulation related improvement of function are     associated with increases in the grey matter of targeted brain areas. While there is     therefore some evidence supporting structural reorganization in human M1 in response to motor     learning and cortical stimulation, the mechanisms underlying these changes and their     relationship to functional plasticity are not known. A better understanding of the sequences     of events is critical to development of optimal therapeutic interventions to improve recovery     following stroke. In Specific Aim 1, we will determine if repeated exposure to training     combined with Hebbian-type M1 stimulation enhances functional M1 reorganization in lesioned     M1 of stroke patients. In Specific Aim 2, we will determine if repeated exposure to training     combined with Hebbian-type M1 stimulation enhances structural cortical reorganization in     lesioned M1 of stroke patients and to explore whether these structural changes are related to     the training induced functional cortical reorganization. At the completion of this project,     it is our expectation that we will have determined the effect of Hebbian- type stimulation on     both, functional and structural brain reorganization, thereby obtaining indirect evidence for     the neuronal substrate underlying training related improvement and maintenance of motor     function in stroke patients. This knowledge would be expected to have a substantial positive     impact on treatment for stroke patients that will significantly improve recovery and would     move the field of neurorehabilitation forward.   "
131056|NCT01569594|"     The objective of this registry is to capture and assess device performance data from subjects     undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the     CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry     provides an ongoing post-market surveillance mechanism to document clinical outcomes on the     use of the CorMatrix ECM for Carotid Repair.   "
131154|NCT01568320|"     The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the     safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of     acute, complicate Type B aortic dissection.   "
133764|NCT01534052|"     A study to assess the safety of continued administration of MDV3100 in subjects with Prostate     Cancer who have already undergone treatment with MDV3100 and showed benefit.   "
131057|NCT01569581|"     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family     Picornaviridae.      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by     EV71 infection. Because of these EV71 infection-related public health issues, the research     and development of EV71 vaccine candidates have been heavily promoted.      Recently, several EV71 vaccine candidates have been evaluated in animals but no final results     of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA     vaccine, epitope peptide vaccine, virus-like particles (VLPs).      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA     in China, Dec. 2010. The phase I clinical and phase II trials were completed, in Guangxi     Province, China. The results of these clinical trials showed that this vaccine was safe and     could induce effective antibodies for the infants. The purpose of phase III is to evaluate     the protected and efficacy of the formalin-inactivated EV71 vaccine in Chinese infants and     children (from 6 to 71 months old).   "
131058|NCT01569568|"     The purpose of this study is to use various types of MRI and cognitive testing to evaluate     changes in the brain and cognitive function that occur in subjects with ornithine     transcarbamylase deficiency (OTCD) relative to healthy individuals   "
131059|NCT01569555|"     By determining the correlation of a Crossed Leg Sign with signifcant pathology, a clinician     would then be able to use this correlation to risk stratify his/her patients for significant     pathology.   "
131060|NCT01569542|"     By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician     would then be able to use this correlation to risk stratify his/her patients for significant     pathology.   "
131061|NCT01569529|"     The purpose of this study is to determine whether tailored online advertisements will drive     young adult smoker's (18 to 26 years old), who are motivated to quit, to use Internet-based     cessation treatment.   "
131062|NCT01569516|"     The main purpose of this study is to evaluate the safety and efficacy of     Octohydroaminoacridine Succinate tablets and find the optimal dose in patients with mild to     moderate Alzheimer's Disease.   "
131063|NCT01569503|"     The purpose of this study is to determine whether (VNS) Vagus Nerve Stimulation , is     effective in the treatment of Crohn's disease.   "
131064|NCT01569490|"     This study is designed to test the hypotheses that incentives can increase both participation     in smoking cessation treatment and resulting cessation rates, when they are offered to     Medicaid BadgerCare Plus pregnant smokers.   "
131065|NCT01569477|"     This study is designed to test the hypotheses that incentives can increase both participation     in smoking cessation treatment and resulting cessation rates when they are offered to     Medicaid BadgerCare Plus members.   "
131066|NCT01569464|"     The purpose of the study is to show that Rotigotine improves Restless Legs Syndrome (RLS)     symptoms in subjects with moderate to severe RLS during both day and evening.   "
131067|NCT01569451|"     The purpose of this study is (1) to determine if rituximab induction therapy followed by     glatiramer acetate (GA) is substantially superior to placebo induction followed by GA for the     treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis     (RMS) and (2) to explore the changes in lymphocyte populations in the CNS as a consequence of     treatment with rituximab followed by chronic GA therapy.   "
131070|NCT01569412|"     Patients with HER2/neu expressing solid tumors progressing after standard therapy will be     treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this     trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as well     as efficacy.   "
131071|NCT01569399|"     Prior research in substance dependence has suggested potential anti-craving effects of     repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral     prefrontal cortex (DLPFC). The aim of the investigators study was to investigate the effect     of high frequency rTMS of the left dorsolateral prefrontal cortex compared to sham     stimulation on craving and alcohol consumption.   "
131072|NCT01569386|"     Low intensity physical activity by half squat of the elderly people with hemiplegia     significantly slow down the pulse wave velocity of the arteries of the lower limbs of the     paralyzed side within 8 weeks.   "
131073|NCT01569373|"     Samples of blood and urine will be analyzed for biomarkers to check their predictivity of     Graft-versus-Host Disease (GVHD) outcomes.   "
131074|NCT01569360|"     Corsets are often used in the management of patients with a spinal cord injury. They may help     to rigidify the patients' trunk which might help some patients to sit upright; their use may     also reduce the sensation of dyspnea some patients have while sitting upright. Due to spinal     cord injury, abdominal muscles are weakened which can contribute to alter the respiratory     function of the patients. But the corset by rigidifying the abdominal wall can improve the     efficiency of the respiratory muscles in some patients and reduce dyspnea in the sitting     position for some patients. However, when patients with spinal cord injury are followed over     time, one can observe that some patients discontinue corset use. The investigators observed     that the patients who pursue the corset use still have a significant improvement of their     respiratory function with the corset while the patients who have discontinued the use have     improved their respiratory function in the upright position (without the corset). As of now,     the investigators do not know whether the use of the corset is discontinued because of a     spontaneous improvement of the respiratory function or whether discontinuing the use of the     corset may help to develop abdominal spasticity and therefore to improve respiratory     function. The investigators seek to investigate this issue in order to optimize the     management of patients who present spinal cord injury.   "
131075|NCT01569347|"     The aim of this study is to determine the clinical, genetic and environmental factors     associated with the phenotype severe psychotic symptoms caused by cocaine.   "
131201|NCT01567709|"     This phase I trial studies the side effects and the best dose of alisertib when given     together with vorinostat in treating patients with Hodgkin lymphoma, B-cell non-Hodgkin     lymphoma, or peripheral T-cell lymphoma that has come back. Alisertib and vorinostat may stop     the growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
131076|NCT01569334|"     Heart transplantation is the best option for patients with end-stage heart failure. Cardiac     allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation     and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of     coronary artery disease (CAD) with similarities to atherosclerosis but also particular     features of endothelial dysfunction associated to the alloimmune conflict and humoral     responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method     for late CAV diagnosis, but occurs lesions are established. Identification of reliable     non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage     thus remain a major challenge to optimize therapeutic management of post transplant     morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from     a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by     recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16)     and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA     receptors), Natural Killer (NK) cells represent effector cells with unique potential to     generate both humoral and innate immune injury of graft endothelium.   "
131077|NCT01569321|"     Breast cancer is the first cancer in women, the second etiology of death by cancer and the     first cause for women between 35 and 55 years.      Diagnostic tools and large screening have been realized with positive impact in a recent     review with 31% less likely to die of breast cancer over nearly 30 years compared to women     who didn't get regular screening mammograms. Diagnostic tools and treatment also are     improving continuously.      However, for some women, breast cancer diagnosis is difficult, in case of high density     breast, breast modifications after surgery… In these cases, breast MRI is currently the best     imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that     lead to futile biopsies.      Recently, molecular imaging with PET-CT scan with 18FDG has permitted to widely modify cancer     treatment.      However, PET-CT scan is not a good imaging tool for initial diagnostic of breast tumor     because of a lack in spatial resolution about 8mm. So, researchers developed dedicated PET     scan for breast, called Positron Emission Mammography. Our project is in this field of view     and is named CLEARPEMSONIC.      First clinical studies with PEM showed very good performance of this imaging modality for     initial evaluation of breast tumors. PEM performance is not affected by breast density,     hormonal status. Spatial resolution is less than 3mm. PEM seems complementary with MRI,     adding a better specificity value.      In the field of CERIMED, ClearPemSonic Project aims to evaluate an new imaging tool which     combined PEM scan and ultrasonography.      Technologic evaluation was made. Now a feasibility study is the first step for clinical     applications.      The main objective of this project is to confirm the feasibility of PEM scan with the     ClearPEmSonic.      Secondary objectives are to compare results with other conventional imaging modalities and     MRI.      The gold standard will be histology of the breast tumor.   "
131078|NCT01569308|"     Objective: To determine the value of pulse pressure variation (ΔRESPPP) to predict fluid     responsiveness in patients ventilated with low tidal volumes (VT), and to investigate whether     a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal     volumes.      Methods: This cross-sectional, observational study included 37 critically ill patients with     acute circulatory failure requiring fluid challenge. They were sedated and mechanically     ventilated with Tidal Volume (VT) 6-7 ml/kg IBW (ideal body weight), monitored by pulmonary     artery catheter and arterial line. Mechanical ventilation and hemodynamic parameters,     including ΔRESPPP, were measured before and after fluid challenge with 1,000 ml crystalloids     or 500 ml colloids. Fluid responsiveness was defined as an increase of at least 15% in     cardiac index.      The present study was designed to (1) determine the value of ΔRESPPP to predict fluid     responsiveness in patients ventilated with low tidal volumes, and (2) to investigate whether     a lower ΔRESPPP cut-off point should be used when patients are ventilated with low tidal     volumes.      The study hypothesis is not a good predictor of fluid responsiveness in patients ventilated     with low tidal volumes.   "
131079|NCT01569295|"     This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of     idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be     randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib or     placebo. All subjects will be administered bendamustine and rituximab.   "
131080|NCT01569282|"     Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in     patients planned for curative pancreatic resection in whom peroperative findings makes     resection impossible.   "
131082|NCT01569256|"     Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting     follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin     like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth     factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome     (OHSS).   "
131083|NCT01569243|"     This study is a 2-arm randomized controlled trial examining the effect of personalized text     messages on physical activity and clinical outcomes in patients with type 2 diabetes     mellitus.      The investigators hypothesize that:      i. The use of personalized text messages will promote physical activity in patients with     T2DM.      ii. Increased physical activity and behavior change correlate with better clinical outcomes     (Change in HbA1c).      iii. The text messaging program will lead to sustained physical activity behavior change in     patients with T2DM   "
131084|NCT01569230|"     The purpose of this study is to verify the efficacy and safety of acupuncture treatments     (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).   "
131085|NCT01569217|"     The aim of this study is to better discriminate respiratory muscle dysfunction by comparing     the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the     conventional tests of respiratory muscle strength. The final objective is to better select in     the future the patients who need more specific assessment of diaphragmatic function like     maximal transdiaphragmatic pressure measurement and phrenic nerve stimulation.   "
131086|NCT01569204|"     The Purpose of this trial is:        -  to determine complete response rate (CRR) after six cycles of chemotherapy        -  to determine complete remission rate (CR/CRr) as final treatment outcome after          completion of treatment   "
131110|NCT01568892|"     Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo-     controlled, functional monotherapy phase to quantify the antiviral activity attributable to     dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological     failure on an Integrase inhibitor containing regimen (current RAL or ELV failures), with     evidence of genotypic resistance to RAL or ELV at study entry. Thirty subjects will be     randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current     failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing with DTG). At     Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg     BID with an optimized background regimen containing at least one fully active drug.   "
131087|NCT01569191|"     Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many     people, caused by hypersensitivity to normally harmless substances such as pollen, and often     accompanies seasonal hay fever. Treatments that can be used before initiating medical therapy     include artificial tear supplements (ATS) and cold compresses (CC). However, there is no     evidence in the scientific literature that demonstrates their efficacy compared to no     treatment or their combined effect with anti-allergic medication. Therefore the investigators     aim to examine the efficacy of ATS and CC alone, in comparison to anti-allergic medication,     and CC in combination with anti-allergic medication. In addition, the investigators also aim     to determine the time course of ocular allergic reactions. At the end of the study the     investigators will be able to see whether or not ATS and CC are effective in treating SAC.   "
131088|NCT01569178|"     This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase     III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone     marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with     reduced left ventricular ejection fraction(</=45%) after successful reperfusion for acute     myocardial infarction when compared to a control group of patients undergoing best medical     care.   "
131089|NCT01569165|"     The aim of this study was to determine whether rinsing with water or cleansing teeth after     topical fluoride therapy affect the dental plaque pH.   "
131090|NCT01569152|"     The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate     (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy. The primary     hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as     measured by the percentage of participants who achieve American College of Rheumatology 20     (ACR 20) response after 12 weeks of treatment.   "
131091|NCT01569139|"     Medical information is increasingly processed electronically. This study will describe the     similarities and differences in the data recorded by different databases of electronic     healthcare database. These will include the General Practice Research Database (GPRD) and the     Myocardial Ischaemia National Audit Project (MINAP) and hospital episode statistics (HES).   "
131092|NCT01569126|"     The purposes of this study are to look at safety, how well the study drug (LY110140) is     tolerated, and how much of the study drug gets into the blood stream when given as single     dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will     participate in SD portion for approximately 6 weeks and in MD portion for approximately 10     weeks.   "
131093|NCT01569113|"     The purposes of this study are to compare the effects on ovarian activity of quick starting a     Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.   "
131094|NCT01569100|"     The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins,     have recently been demonstrated to improve endothelial function. Additionally, numerous     studies have shown statins as having antiinflammatory and cell-signaling effects together     with a selective up-regulation of the eNOS activity. These findings are of potential benefit     for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed,     one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of     eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate     effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and     outcome at one year.   "
131095|NCT01569087|"     The purpose of the study is to compare safety and efficacy of a single dose of     empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5     μg/kg/day.   "
131096|NCT01569074|"     The purpose of the study is to evaluate the effectiveness of four dosing regimens of     fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking     methotrexate but not responding. The study will last for 12 weeks.   "
131097|NCT01569061|"     The primary objective of this study is to determine the effectiveness of     transvaginally-delivered low level laser therapy (LLLT) versus Sham in the treatment of     overactive bladder symptoms in women. The secondary objective is to determine the effect of     transvaginally-delivered LLLT vs. sham on the quality of life.   "
131108|NCT01568918|"     Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a     large portion of this population which results in increased morbidity as a result of     increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital     stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the     incidence and duration of postoperative urinary retention and therefore a reduction in     morbidity related to treatment of urinary retention as well as shortened hospital stays.   "
131098|NCT01569048|"     Various maneuvers are commonly used to achieve the ideal operative field necessary for     successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor     agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the     hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral     vasoconstriction thus it is thus theologically appropriate for reducing bleeding during     intranasal operation.      The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor     agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to     remifentanil , an ultrashort-acting opioid.   "
131099|NCT01569035|"     This study examines using oral anti coagulant warfarin in the management of unexplained     oligohydramnios improve the perinatal outcome with little or no complications to the mother     or the neonates.   "
131100|NCT01569022|"     Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder     (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in     patients with PTSD compared to those without PTSD and contribute to worsening cognitive and     behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment     of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general     population. The proposed study aims at comparing the efficacy, tolerability, and adherence of     oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in     identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would     predict oral appliance response   "
131111|NCT01568879|"     The aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based     chronic disease management program compared to patients receiving usual care in achieving a     target serum uric acid level in patients with recurrent gout.   "
131101|NCT01569009|"     The primary aim of this study is to examine the physical activity levels of patients with     bronchiectasis.      Subsidiary aims are:        1. To examine whether there is a relationship between the physical activity levels of          patients with bronchiectasis and clinical phenotype (disease severity, exercise          capacity, quality of life or other symptoms of their disease). The investigators also          want to explore the relationship between physical activity levels and readiness to          change physical activity behaviour (stages of change, self-efficacy, decisional balance          and processes of change).        2. To assess the feasibility and acceptability of the physical activity assessment tools:          ActiGraph, ActivPAL, pedometer and the International Physical Activity Questionnaire.      Hypothesis:      Patients with bronchiectasis will have low levels of physical activity, and this is related     to their clinical phenotype (disease severity, exercise capacity, quality of life and other     symptoms of their disease) and also their readiness to change physical activity behaviour     (stages of change, self-efficacy, processes of change and decisional balance).   "
131102|NCT01568996|"     This is a pilot study to see if oral administration of freeze dried, powdered broccoli     sprouts have any effect on whether moles end up becoming melanoma.   "
131103|NCT01568983|"     The purpose of this study is to investigate the effects of berry juices containing different     levels of polyphenols on blood pressure and other cardiovascular risk factors.      The study is a 12 week double blinded randomized controlled intervention trial. The subjects     will be divided in three groups where one receives a placebo juice while the two other will     consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will be     monitored and blood samples will be taken.   "
131104|NCT01568970|"     The large number of people on long-term sick leave is a major public health concern in     Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term     sick leave causes a decline in individual life-quality, is associated with increased risk for     mental disorders and represents a very large cost for the Norwegian society.      The purpose of this study is to determine whether the patients included return to work after     rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is     considered to be the effect of Return-to-work rehabilitation measured before, during and     after the stay at the rehabilitation centre:      The study specifically looks at the effect of structured and standardized return-to-work     follow up of the patient, including contact with stakeholders (general practitioner, social     security office and workplace).      In addition there is a need to describe the patients participating in the program. The     aetiology of complex symptom disorders is poorly understood and the role of genetics and     stress is not translatable to a complex symptom population. This complicates the transition     from current biological research to a clinical use regarding these patients. If the     investigators can assist in understanding how these patients, who are multiusers of health     care and have received sickness benefit for a long time, develop their disorders and     symptoms, it will be of great importance to the Norwegian community. Therefore the study     consists of multimodal measurements of the patients before, during and after a rehabilitation     programme at Hysnes Rehabilitation Centre. These measures include genotype, saliva cortisol,     medical-, psychological-, physiological diagnostics and work related factors.      Related aims:      Investigate if multidisciplinary treatment based on acceptance and commitment therapy,     contributes to normalisation of cortisol release with regards to a standardized stress test.      See wether individual differences regarding the stress profile can predict return to work in     patients with complex symptom disorders.      Investigate genetic risk factors in relation to Return to Work rehabilitation and identify     treatment moderators in a multidisciplinary rehabilitation program.   "
131105|NCT01568957|"     Community ambulation is a highly complex skill requiring the ability to adapt to increased     environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking     may severely compromise the ability to participate fully in community living. Unfortunately,     current rehabilitation practice for stroke fails to adequately address dual-task limitations;     individuals with stroke continue to exhibit clinically significant dual-task costs on gait at     discharge. As a result, many stroke survivors are living in the community with residual     deficits that may increase disability in the real world and lead to falls with devastating     consequences. To address this issue, the proposed study investigates the efficacy of     dual-task gait training on attention allocation and locomotor performance in     community-dwelling stroke survivors. Because walking in the real world often requires     time-critical tasks and obstacle avoidance, the investigators will test the impact of     dual-task gait training on cognitive-motor interference during walking at preferred speed and     at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The     investigators will also evaluate the effects of the intervention on community reintegration     and participation (Aim 3).   "
131106|NCT01568944|"     The investigators hypothesize that blood dendritic cells harbor pathogens from the oral     cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.   "
131107|NCT01568931|"     Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of     ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of     myocardial tissue.      Although the use of thrombus aspiration with PCI can result in improved rates of normal     epicardial flow and myocardial perfusion, several unmet needs remain.      Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of     thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective     in patients with STEMI.   "
142947|NCT01413347|"     The purpose of this study is to devise the method to reduce displacement of a left-sided     double-lumen tube during patient positioning.   "
131109|NCT01568905|"     Smoking remains a leading cause of preventable disease and premature death worldwide.     Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half     of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine     in cigarettes to the point that they are rendered non-addictive can potentially be an     effective public policy measure that can significantly reduce tobacco-related mortality and     morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking     Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product     standards including placing limits on the allowable nicotine content of cigarettes.     Currently, no reduced nicotine cigarettes are available that will allow studying the     feasibility of this policy measure. The National Institute on Drug Abuse has contracted with     Research Triangle Institute to assist in the development of cigarettes with varying nicotine     content that can be made available to researchers. They have established a contract that will     result in the manufacture of 9 million cigarettes to be distributed to the research     community. Prior to full production, the palatability and nicotine intake of these cigarettes     in smokers must be determined.   "
131112|NCT01568866|"     The primary objective of this study was to compare progression-free survival in patients with     multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus     dexamethasone or bortezomib plus dexamethasone.   "
131117|NCT01568801|"     This is a RCT studying the effectiveness of the Singapore Program for All Inclusive Care for     the Elderly (SingaPACE) demonstration project over a 36 month period. SingaPACE is modelled     on the US PACE home and community based service that acts as an alternative to institutional     care. The comparator is best referrals for care as currently arranged through the Agency for     Integrated Care (AIC) and referred by medical social workers. This research aims to determine     how the SingaPACE model of health and social care affects use of emergency and acute care     hospital services, institutional care, the quality of life (QOL) and satisfaction of the     participants aged 60+ and their caregivers.      The hypotheses to be tested are:      H01: The elderly in SingaPACE will have fewer admissions to accident & emergency (A&E)     hospitalization than the elderly who are not in SingaPACE.      H02: The elderly in SingaPACE will have fewer admissions to acute care hospitalization than     the elderly who are not in SingaPACE.      H03: The elderly in SingaPACE will delay first admission to institutionalized nursing home     care more than the elderly who are not in SingaPACE.      H04: The elderly in SingaPACE clients will have a higher QOL compared to the elderly who are     not in SingaPACE.      H05: Caregivers of the elderly in SingaPACE will have a lower care-giving burden compared to     caregivers of the elderly who are not in SingaPACE.   "
131118|NCT01568788|"     Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May,     2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza     vaccine of Hualanbio has obtained production permission and marketing authorization in May,     2008.      In order to further investigate the safety and immunogenicity of the vaccine in the market,     The clinical observation was planned to be conducted in Mianyang city (Yanting County),     Sichuan Province, China.   "
131119|NCT01568775|"     This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy     subjects and patients with End Stage Renal Disease on hemodialysis.   "
131120|NCT01568762|"     This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258     (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in     patients with well-controlled mild to moderate asthma.   "
131121|NCT01568749|"     A study investigating the pharmacokinetic profiles of four extended release paracetamol     formulations   "
131145|NCT01568437|"     Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid     obesity, which is performed under general anesthesia. TAP block is an analgesic strategy     covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP     between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are     located. As far as the investigators know, this analgesic technique has never been studied in     LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block     provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass     surgery, compared to conventional therapy only.   "
131122|NCT01568736|"     The hyper IgD syndrome (HIDS) is an inflammatory disease caused by mevalonate kinase     deficiency. There is no cure, and available treatments of HIDS febrile episodes have shown     limited clinical efficacy. The development of effective interventions for HIDS is limited by     our poor understanding of the disease. The goal of the study is to better characterize the     inflammatory response during HIDS episodes and to determine the relationship between this     response and blood and urine markers of mevalonate kinase deficiency. This knowledge will     help us learn more about the cause of the disease and should lead to the identification of     new disease biomarkers that can be used to evaluate clinical efficacy in future therapeutic     trials.      The primary hypothesis is that the costimulatory B7 glycoprotein abnormalities identified in     the murine MKD model will be recapitulated in sera obtained from human HIDS patients, either     before, during or after febrile episodes. The secondary hypothesis is that B7 glycoprotein     molecule levels will correlate with clinical symptomatic severity score, other known     biomarkers of HIDS, markers of inflammation and or markers of isoprenoid metabolism.   "
131123|NCT01568723|"     The purpose of this study is to determine biomarkers which can predict response to ablation     therapy in patients with Barretts esophagus.   "
131124|NCT01568710|"     Background:      - Many people with sickle cell disease have repeated episodes of severe pain that lasts for     days, requiring hospital care. These episodes, called pain crises, may be caused by changes     in blood flow. Researchers want to study blood flow in people with sickle cell disease who     are having a pain crisis and compare it with their blood flow after the pain crisis has     resolved. They also want to compare these measurements against blood flow in healthy people     who do not have sickle cell disease.      Objectives:      - To study whether changes in blood flow cause pain crises in people with sickle cell     disease.      Eligibility:        -  Individuals at least 18 years of age who have sickle cell disease and are being treated          for a pain crisis.        -  Individuals at least 18 years of age who have sickle cell disease and are not          experiencing a pain crisis.        -  Healthy volunteers matched by age and gender with the participants who have sickle cell          disease.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants having a sickle cell pain crisis will have two visits, one during the          crisis and one about 4 weeks after the crisis has resolved.        -  Participants not having a sickle cell pain crisis will have one or two study visits.          Blood samples will be collected during at least one of these visits.        -  Healthy volunteers will have one or two study visits. Blood samples will be collected          during at least one of these visits.        -  During each visit for all participants, cameras and blood flow monitoring equipment will          be used to measure blood flow in the forearm.      sickle cell disease.   "
131171|NCT01568099|"     This is a phase I study to assess the tolerability and safety of 4 injections of two     different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early     Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45     years if there is no evidence for genetic forms of the disease and the diagnosis of     idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in     Vienna (Austria) will be involved. Each patient's participation will last 1 year.      In addition, up to 8 patients will be offered participation within an untreated control     group.   "
131172|NCT01568086|"     This is a phase Ib follow-up study to evaluate long-term safety and tolerability of     immunization with AFFITOPE AD03 applied during AFFiRiS 005A.   "
131125|NCT01568697|"     Background:      - Gum disease is a condition in which the tissue around the tooth root becomes swollen and     infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and     how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune     system of an individual handles these bacteria. Researchers want to look at the oral bacteria     and genetic immune problems of different people to learn how these affect gum disease and     other conditions of the mouth.      Objectives:      - To study how immune system problems may lead to problems in the mouth, including gum     disease.      Eligibility:        -  Children and adults at least 7 years of age who have genetic problems with their immune          system.        -  Healthy adults that have periodontal disease        -  Health adults that do not have periodontal disease      Design:        -  This study will involve a screening visit and a study visit.        -  Participants will be screened with a medical history, blood work and a full oral and          dental exam, including dental x-rays and photos.        -  The study visit will involve collection of blood, urine, and other samples, including          saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional          oral and dental exams will be performed. Participants will also answer questions about          any current medical or dental problems.   "
131126|NCT01568684|"     Background:      - Antidepressants help many people with depression, however, some do not seem to benefit as     much. Currently, it is not possible to determine who will improve with certain     antidepressants. Studies have shown that genes may influence whether an antidepressant works     for an individual. Other studies have shown that depressed people tend to have lower levels     of a chemical called glutamate in parts of their brain, and that glutamate levels increase     after recovering from depression. Researchers want to study the antidepressant citalopram     (Celexa) to see how it affects glutamate levels in the brain. They also want to study how a     person s genes affect their response to this treatment.      Objectives:      - To see whether glutamate levels and certain genes affect how a person responds to a     particular antidepressant medication.      Eligibility:      - Individuals between 25 and 55 years of age who have been diagnosed with major depression     (without psychotic features). Participants may not have tried more than three antidepressant     treatments.      Design:        -  Participants will be screened with a physical exam and medical history. They will answer          questions about mood and current feelings of depression, as well as family history of          depression. Blood and urine samples will be collected.        -  This study will have two phases. The first phase may last up to 7 weeks depending on          current antidepressant use and involves one to seven outpatient visits. The second phase          lasts 8 weeks and involves five outpatient visits, one every 2 weeks.        -  In the first phase, participants will stop taking their current antidepressant          medications for at least 2 weeks before the next phase of the study. Participants who          are on fluoxetine (Prozac) will need to be off it for 6 weeks.        -  At the end of this phase, participants will have brain imaging studies to look at brain          function and chemistry.        -  In the second phase, participants will take citalopram at the standard dose. They will          answer questions about mood and response to the medication. They will also provide blood          and saliva samples for tests.        -  At the end of this phase, participants will have brain imaging studies to look at brain          function and chemistry.   "
131127|NCT01568671|"     Background:      - The way that the body burns calories is known as energy expenditure. Some studies show that     when we are cold, we burn more calories to keep our bodies warm. Brown fat is a special kind     of fat that can use energy to keep the body warm. Small animals and infants have been known     to have brown fat for many years. Recently, it has been suggested that adult humans also have     brown fat. If brown fat becomes active (burns calories) in adult humans when exposed to cold,     then these people would tend to burn off more calories and might not gain weight easily.     Learning more about the relationship between energy expenditure, brown fat, environmental     temperature, and body temperature may help explain why some people become obese and other     people do not.      Objectives:        -  To better understand how the body burns calories when exposed to different temperatures.        -  To study brown fat and how it burns calories in cold temperatures.      Eligibility:        -  Healthy men between 18 and 35 or 55 and 75 years of age.        -  Healthy women between 18 and 35 years of age.        -  To control for ethnicity, participants must be non-Hispanic whites or African Americans.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will stay in the Metabolic Unit of the National Institutes of Health          Clinical Center as inpatients for no more than 14 days. The length of the hospital stay          will depend on how participants respond to the different study temperatures.        -  Every afternoon, participants will walk for 30 minutes on a treadmill. All meals will be          provided.        -  Participants will stay up to 5 hours per day in a specialized room with different          temperature settings. Temperatures will range from about 61 degrees to 88 degrees          Fahrenheit. Body temperature, activity, calorie burning, and cold/hot sensations will be          monitored. On the study day of the coldest temperature, participants will have an          imaging study to look for brown fat activity.        -  Participants will be compensated for their time and participation at the end of the          study....   "
131128|NCT01568658|"     Background:      - Some nerve and muscle disorders that start early in life (before age 25), like some forms     of muscular dystrophy, can run in families. However, the genetic causes of these disorders     are not known. Also, doctors do not fully understand how symptoms of these disorders change     over time. Researchers want to learn more about genetic nerve and muscle disorders that start     in childhood by studying affected people and their family members, as well as healthy     volunteers.      Objectives:      - To better understand nerve and muscle disorders that start early in life and run in     families.      Eligibility:        -  Individuals at least 4 weeks old with childhood-onset muscular and nerve disorders,          including those who have a later onset of a disorder that typically has childhood onset.        -  Affected and unaffected family members of the individuals with muscular and nerve          disorders.        -  Healthy volunteers at least 4 weeks old with no nerve or muscle disorders.      Design:        -  Participants will be screened with a physical exam and medical history. Genetic          information will be collected from blood, saliva, cheek swab, or skin samples. Urine          samples may also be collected.        -  Healthy volunteers and unaffected family members will have imaging studies of the          muscles. These studies will include magnetic resonance imaging (MRI) and ultrasound          scans. Results will be compared with those from the affected participants.        -  All participants with nerve and muscle disorders will have multiple tests, including the          following:        -  Imaging studies of the muscles, including ultrasound and MRI scans.        -  Imaging studies of the bones, such as x-rays and DEXA scans.        -  Heart and lung function tests.        -  Eye exams.        -  Nerve and muscle electrical activity tests and biopsies.        -  Video and photo image collection of affected muscles.        -  Speech, language, and swallowing evaluation.        -  Lumbar puncture to collect spinal fluid for study.        -  Tests of movement, attention, thinking, and coordination.        -  Participants with nerve and muscle disorders will return to the Clinical Center every          year. They will repeat the tests and studies at these visits.   "
131129|NCT01568645|"     Background:      - About one-tenth of adults with sickle cell disease have pulmonary hypertension (high blood     pressure in the lungs). This condition can cause shortness of breath, pain crisis, and     congestive heart failure. It may even lead to death. Researchers want to test the drugs     imatinib and carvedilol to see if they can treat high blood pressure in the lungs. Both drugs     have been used to treat other types of heart problems, but they have not been tested as a     treatment for high blood pressure related to sickle cell disease.      Objectives:      - To see if imatinib and carvedilol are safe and effective treatments for high blood pressure     in the lungs in adults with sickle cell disease.      Eligibility:      - Adults at least 18 years of age who have sickle cell disease and have or may have high     blood pressure in the lungs.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have different tests of heart and lung function, including a walking test and imaging          studies. Blood and urine samples will also be collected.        -  Participants who meet specific criteria will take one of two possible study drugs. Those          who receive imatinib will take it daily. Those who receive carvedilol will take it twice          a day.        -  Participants will have weekly study visits for blood tests and other exams. The study          drug dose will be adjusted at each weekly visit. It will be increased slowly to reach a          target dose(based on the participant s weight) or to find a stable effective dose.        -  Participants may continue to take their study drug for up to 24 weeks, with weekly study          visits. Regular blood samples and heart and lung function tests will be performed.        -  After 24 weeks, qualified participants may continue to take their study drug for up to 6          more months. They will have regular study visits to monitor the treatment.   "
131169|NCT01568125|"     It is well known that incretin, particular GLP-１enhances satiety and reduces energy intake in     controlling appetite and dietary in humans (Flint A, et al. Gutzwiller JP et al.). Recently,     incretin-based therapy has been attracted a lot of interest (Hare KJ, Knop FK). However, it     is not clear how the incretin-based therapy affects energy and content of dietary intake in     patients with type 2 diabetes mellitus (T2DM). Previously, the investigators reported the     amount of energy and content of dietary intake in type 2 diabetic Japanese patients with more     than 10 years of long time duration after discovery using questionnaire (Inoue K et al.) and     the patients were impaired a secretion of active GLP-1 (Kamoi et al).      The investigators examine whether the incretin-based therapy effects on the energy and     content of dietary intake in the same patients before and one year after administration of     incretin-related drugs using the same method previously (Inoue K et al.).   "
131130|NCT01568632|"     Background:      - Imetelstat is a cancer treatment drug that may slow or stop tumor growth. It may also     prevent tumors from spreading to other parts of the body. Researchers want to see if it can     be a safe and effective treatment for children who have solid tumors or lymphoma that have     not responded to other treatments.      Objectives:      - To see if imetelstat is a safe and effective treatment for children who have solid tumors     or lymphoma that have not responded to other treatments.      Eligibility:      - Children and adolescents between 1 and 21 years of age who have solid tumors or lymphoma     that have not responded to other treatments.      Design:        -  Participants will be screened with a physical exam, medical history, and imaging          studies. Blood and urine samples will also be collected.        -  Participants will receive imetelstat on the first and eighth day of a 21-day cycle of          treatment.        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor          biopsies may also be performed.        -  Participants will keep taking the study drugs for up to a total of 18 cycles as long as          the disease does not progress and there are no severe side effects....   "
131131|NCT01568619|"     The investigators would like to find out if AESCULON®, a new device that non-invasively and     continuously measures cardiac output using electrical cardiometry, works as well as one     existing method--Fick method in patients undergoing cardiopulmonary exercise testing.   "
131132|NCT01568606|"     The purpose of this study is to define the safety of using bioimpedance for analysis of body     composition in heart failure patients with ICD devices. The Biospace America InBody 520     scale, using direct segmental multifrequency bioimpedance, will be utilized to assess     patients' fat mass, lean muscle mass, and edema status.      Although the Biospace America InBody 520 scale is routinely used to analyze body composition     in various settings including the Ahmanson-UCLA Cardiomyopathy clinic, due to theoretical     concerns of safety, bioimpedance has not been routinely used in patients with ICDs. The     investigators hope that this study will allow us to routinely analyze body composition in     heart failure patients with ICDs, information which can be used to help guide dietary,     exercise, and medical prescriptions for the investigators heart failure patients.   "
131133|NCT01568593|"     Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to     severe Dry Eye Syndrome   "
131134|NCT01568580|"     The purpose of this study is to study the evaluation of efficacy and safety of GreenGene     (Recombinant Factor VIII).   "
131135|NCT01568567|"     Lactobacilli are commensal bacteria common to the gut of all mammals studied and     traditionally associated with foods are considered safe.The established safe use on a     diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus     reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of     humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as     well as adults.      Although the tolerability of DSM 17938 in a tablet formulation has earlier been established,     it is desirable to repeat the assessment in this novel formulation.   "
131136|NCT01568554|"     The purpose of this study is to test whether a focused questionnaire and laboratory tests can     better define risk factors associated with possible genetic porphyria. The investigators     hypothesize that the genetic carrier state of acute porphyria is distinctive enough that the     Genetic Carrier Profile the investigators devise through this study will be useful in     identifying carriers of genetic porphyria among the large population with undiagnosed     abdominal pain.   "
131137|NCT01568541|"     There are controversial data about fluoride intake by children when tooth brushing with     children's or regular toothpastes. However, a study have showed that children were exposed to     a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and     regular toothpaste, respectively. Fluorides doses were too close and is questioned if there     is a real clinical relevance in terms of risk of dental fluorosis. It is important to     evaluate if children's toothpastes does really represent a risk of fluoride intake when     compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is     that both children's and regular toothpastes can represente risks of development of dental     fluorosis and can represent similar fluoride exposure by children.   "
143693|NCT01402531|"     This is a research study to find out more about the use of Avastin (proper chemical name is     bevacizumab) in the treatment of epistaxis (nose bleeding) in patients with Hereditary     Hemorrhagic Telangiectasia (HHT).   "
131138|NCT01568528|"     The focus of the current project is to advance our understanding of the effects of oxytocin     (OT) on components of social cognition in schizophrenia (SCZ). Despite the rapid increase in     our understanding of the role of OT in rodent models of social behavior and an explosion of     interest in the prosocial effects of OT in healthy controls, little work has been done to     dissect the potential effects of OT on SCZ subjects with social deficits. Social deficits are     a crucial aspect of the functional impairments that limit the rehabilitation of patients with     SCZ. In particular, SCZ patients with enduring negative symptoms (deficit syndrome,     Kirkpatrick et al. 1989) have prominent social deficits as a core feature of this subtype of     the illness. Our currently available medications do very little to improve these social     deficits. Hence it is of utmost public health importance to address the knowledge gap     regarding the potential of OT to improve social function in this illness. Intact social     function depends on the competent functioning of several cognitive domains that subserve     perception of social cues and the generation of motivated social behavior. We propose to     conduct a pharmacological challenge study of OT vs. placebo administration to study the     effects of OT on specific components of social cognition in male deficit syndrome SCZ     subjects.      Primary Hypothesis: Intranasal OT will improve social cognition in subjects with deficit     syndrome SCZ.   "
131170|NCT01568112|"     The primary objective of the study is to evaluate whether premedication with 325 mg     microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the     incidence and severity of flushing and GI events following oral administration of BG00012     dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this     study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240     mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration     dosing schedule in healthy volunteers.   "
131320|NCT01566149|"     The purpose of this study is to assess the safety, tolerability & effectiveness of 2     strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the     treatment of persistent asthma in adults & adolescents.   "
131139|NCT01568515|"     Introduction: Although vaccination against HPV and subsequent HPV-related cancers is a     significant breakthrough, uptake is low. We sought to understand whether a low-cost     intervention of electronic (text and/or email) appointment reminders coupled with electronic     health educational messaging about HPV and the HPV vaccine could increase HPV vaccine uptake     and knowledge among college students.      Methods: Study participants included both female and male English speaking students between     the ages of 18-26 who attended a large university in North Carolina. Students were randomized     to the intervention or control group. Intervention group participants received the electronic     messaging while the control group received standard of care at the student health center     across a 7-month study period. Baseline and follow-up survey data was collected. Main outcome     measures were completion of HPV-2 and HPV-3 and HPV and HPV vaccine knowledge. Study     recruitment ran from August 2011 to December 2013.      Results: Completion rates for the intervention and control group were similar for HPV-2 (53%     vs. 52%) and HPV-3 (34% vs. 32%), respectively. The mean knowledge score at follow-up for     intervention group participants (n=44, mean knowledge score = 93%, SD = 0.08) was     significantly higher (p=0.01) than the mean knowledge score at baseline (n=44, mean knowledge     score = 87%, SD = 0.11). No significant changes in knowledge from baseline to follow-up were     found for control group participants. The single most important predictor of HPV vaccine     uptake overall was female gender where female participants were 2.35 times [confidence     interval (CI) 1.17-4.69] as likely to complete the series as compared to male participants.      Conclusion: In this sample of college students, the electronic messaging intervention     increased knowledge but not uptake. More randomized controlled trials on the efficacy of HPV     vaccine electronic reminder interventions for catch-up age populations for both females and     males are needed.   "
131140|NCT01568502|"     Dobutamine stress echocardiography (DSE) and cardiac magnetic resonance (DCMR) are both     established non-invasive techniques, used in the clinical routine for the diagnostic     classification and risk stratification of patients with suspected or known coronary artery     disease (CAD).      In this regard, regional wall motion abnormalities (WMA) during dobutamine stress, precede     the development of ST-segment depression and anginal symptoms, enabling the detection of     anatomically significant CAD and the assessment of clinical outcomes.      In a head-to-head comparison between the 2 techniques, favourable diagnostic characteristics     in terms of higher sensitivity and accuracy were noted for DCMR compared to DSE.      Although it has been reported that stress induced WMA both in DCMR and in DSE are independent     predictors for hard cardiac events such as cardiac death or myocardial infarction, the value     of the 2 techniques for the risk stratification of patients with CAD has not been compared to     each other so far.      Comparison of these 2 non-invasive techniques is important, because referring physicians need     to know which modality is more reliable for the identification of patients at higher risk for     subsequent cardiac events, who would benefit from early invasive therapy.      In the investigators study the investigators therefore sought to compare the ability of DSE     versus DCMR to predict subsequent hard cardiac events and revascularization procedures in a     patient cohort with high CAD prevalence. Their predictive value was compared to that of     conventional atherogenic risk factors and to resting WMA. In addition, the investigators     sought to determine if both techniques are equally suitable for structuring invasive or     conservative treatment according to the presence or absence of inducible ischemia,     respectively.   "
131141|NCT01568489|"     The objective of this phase 2 study is to evaluate the safety and efficacy of HL-009     Liposomal Gel in adult patients with mild to moderate atopic dermatitis (AD).   "
131142|NCT01568476|"     Following foot and ankle surgery, ultrasound-guided sciatic nerve block (SNB) at the     popliteal fossa decreases post-operative pain and opioid consumption. At the popliteal fossa,     the sciatic nerve bifurcates to form the Common Peroneal Nerve (CPN) and Tibial Nerve (TN).     Studies have shown that when both branches are blocked separately distal to the bifurcation     site, block onset time is reduced by 30%. Through clinical observation, the investigators     found that onset time is further shortened when ultrasound-guided SNB is performed at the     site of bifurcation. This is because the local anesthetic spreads interneurally. The purpose     of this study is to compare the block onset time of an ultrasound-guided sciatic nerve block     at the site of nerve bifurcation with the blockade of each terminal nerve separately (TN and     CPN) distal to sciatic nerve bifurcation.   "
131143|NCT01568463|"     Patients experience significant postoperative pain following shoulder surgery, Single shot     interscalene block is used in ambulatory shoulder surgery for its advantages that include     significant reduction in acute pain and analgesic requirements, prolonged time to first     analgesic request, decreased incidence of nausea, as well as earlier hospital discharge.The     process of nerve block requires several needle passes, with each of them being at risk of     causing nerve injury either by direct trauma or intraneural injection even with the use of     the ultrasound. These facts raised concerns and several authors stated that maybe the     anesthesiologists should be more careful, keep a safe distance from the nerve, and inject the     local anesthetics into fascial planes containing the nerve and not attempt to place the     needle in close proximity to the nerve. This study is designed to determine the maximal     effective distance away from the nerve for the injection to be effective.   "
131144|NCT01568450|"     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of     GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.      GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.   "
131146|NCT01568424|"     The study objective is to gather post-market clinical data on the use of the CentriMag RVAS     when used for temporary mechanical circulatory support of the right ventricle in patients     with acute right ventricular failure from any cause   "
131151|NCT01568359|"     The purpose of the study is to evaluate the Calcium homeostasis in adult patients with     uncontrolled acromegaly. The measurements will be repeated 3-6 months after the treatment of     acromegaly (surgical or medical). The control group consists of patients with nonfunctioning     pituitary tumors who will undergo surgical removal.   "
131152|NCT01568346|"     This study is being done to find out the number of surgical procedures required to achieve     clear margins in women with newly diagnosed early stage breast carcinoma. The investigators     are also looking at the number of additional biopsies performed before surgery, the     mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma),     time form diagnosis to local therapy, and evaluation time to local recurrence.   "
131153|NCT01568333|"     Decitabine has been reported to have a clinically significant, often long lasting effect on     the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine     could increase platelet counts by enhancing megakaryocyte maturation and platelet release.     Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by     transient or persistent decrease of the platelet count. However, refractory ITP is lacking of     effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data     from this study may provide some idea of decitabine in the treatment of ITP.   "
131155|NCT01568307|"     There is strong evidence that patients with major depressive disorder (MDD) have an increased     risk of developing coronary heart disease (CHD). This elevated risk is independent of     standard risk factors such as smoking, obesity, high cholesterol, diabetes, and high blood     pressure. The relative risk of developing CHD is proportional to the severity of depression     (the more severe the depression, the more likely the development of CHD).      The sympathetic nervous system (the part of your nervous system that makes your heart beat     harder and faster) is responsible for our flight and fight response to a threatening     situation. It has been determined that increased sympathetic nervous system activation occurs     in approximately one in three untreated patients with MDD (with no underlying CHD). There is     growing evidence linking elevated sympathetic activity to early stages of kidney dysfunction     and an increased incidence of cardiovascular (heart and blood vessel) disease development     (eg, heart attacks). Sympathetic nervous system activation over a prolonged period of time     may also be associated with abnormal blood pressure regulation and the development of insulin     resistance (an important feature of type 2 diabetes).      It has been suggested that a certain gene, known as the serotonin transporter (5-HTT) gene,     may be involved. In particular, work from our group indicates that a particular type of this     gene, the short form (or short allele) may be important in linking MDD, sympathetic nervous     activation, and increased cardiac risk.      This study aims to examine the role of the 5-HTT gene on cardiovascular risk factors     associated with elevated sympathetic activity in patients with MDD. Additionally, the study     will examine the effect of serotonin re-uptake inhibitor (SSRI) therapy on these parameters.      A clearer understanding of these systems and processes will allow for identification of     patients with increased cardiac risk and development of risk reduction strategies. Such     information is clinically significant given the link between cardiovascular disease and MDD.      Hypothesis 1: That MDD patients carrying the s allele of the 5-HTT transporter have higher     sympathetic activity than homozygous ll patients.      Hypothesis 2: that MDD patients with elevated sympathetic activity display early signs of     left ventricular hypertrophy (LVH) and diastolic dysfunction.      Hypothesis 3: That MDD patients with high sympathetic activity have greater morning surges in     blood pressure than patients with normal sympathetic activity.      Hypothesis 4: That MDD patients with elevated sympathetic activity display early signs of     insulin resistance.      Hypothesis 5: That SSRI therapy, in particular in those who carry the s allele of the 5-HTT,     has a favourable effect on blood pressure variability and morning surge in blood pressure,     sympathetic stress reactivity, and markers of insulin resistance.   "
131156|NCT01568294|"     The purpose of this study is to determine the tolerated dose of pomalidomide and also to     evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with     refractory or relapsed and refractory multiple myeloma.   "
131157|NCT01568281|"     This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet     after a single oral administration of each anastrozole formulation.   "
131158|NCT01568268|"     This study was designed to evaluate the treatment efficacy and safety of palonosetron for the     patients who undergo laparoscopic gynecologic, abdominal or other surgery under general     anesthesia.   "
131159|NCT01568255|"     Statins are a class of drugs that are highly effective at lowering cholesterol levels.     However, compliance is often limited by symptoms of muscle pain. The investigators would like     to study Vitamin-D deficient individuals who also have muscle pain due to statin use. About 1     billion people are estimated to have low or insufficient levels of vitamin D worldwide.     Patients with low or insufficient levels of vitamin D may develop muscle disease. The purpose     of this study is to identify if these symptoms are associated with vitamin D deficiency, and     most importantly, if treatment of vitamin D deficiency can reduce muscle pain that is caused     by statin treatment.   "
131160|NCT01568242|"     Temperature in the vitreous cavity decreases during vitrectomy, and the same effect is seen     during an uneventful phaco surgery. Significant changes occur between the baseline     temperature and after every step of the surgery.   "
131161|NCT01568229|"     The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of     schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in     period on their current antipsychotic treatment, patients will be randomized to one of the     four treatment arms as add-on therapy for a treatment duration of up to 3 months.   "
131162|NCT01568216|"     The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of     schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in     period on their current antipsychotic treatment, patients will be randomized to one of the     four treatment arms as add-on therapy for a treatment duration of up to 3 months.   "
131163|NCT01568203|"     The purpose of this study is to assess the safety and tolerability of AMG 579 following a     single oral dose administration in healthy subjects (Part A) and in patients with     schizophrenia or stable schizoaffective disorder (Part B). The study in healthy subjects     (Part A) concluded, and following a protocol amendment, enrolled only patients with     schizophrenia or stable schizoaffective disorder (Part B).   "
131164|NCT01568190|"     The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite     mix.   "
131165|NCT01568177|"     Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in     heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3     million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous     system (ANS) is part of the central nervous system to help people adapt to changes in their     environment. It controls what are normally involuntary activities, such as heart rate,     respiration (breathing), body temperature, blood pressure, and urinary function. However,     there is a limited understanding of the role of ANS in MCD. This research is proposed to     investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system     in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac     imaging and cardiac autonomic function testing. 100 participants will be recruited in the     next five years.   "
131166|NCT01568164|"     The purpose of this prospective, single-armed, multi-center clinical trial is to further     establish the safety and feasibility of using the BioVentrix PliCath HF System for the     treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from     heart failure.   "
131167|NCT01568151|"     This study is being done to see if teaching physicians and people who are at least 50 years     old and have not been screened within guidelines for colorectal cancer about the importance     of colorectal cancer screening will increase screenings for colorectal cancer. The     researchers want to understand what ways will work best to motivate and educate both patients     and the doctors and nurses who care for them.   "
131168|NCT01568138|"     The purpose of the study is to determine the safety, and feasibility of a device, which     enables LV volume and radius reduction through scar exclusion in patients whose systolic HF     is due to ischemic cardiomyopathy.      Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV     distribution. Use of this device replicates the geometric reconfiguration of the ventricle     achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating,     unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass     pump (CBP).   "
131173|NCT01568073|"     This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with     entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa     Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose     motor fluctuations.   "
131179|NCT01567995|"     This was a multicenter, randomised, double-blind, two treatment arms, vehicle (cream base)     -controlled, parallel-group study in subjects with moderate to severe eczema (defined by     investigators global assessment (IGA) score greater than or equal to 3).      Subjects were screened within 3 days prior to randomization. At the screen visit, subjects     gave informed consent and were then assessed for health status and eligibility for inclusion     in the study. At the baseline visit, subject eligibility was assessed for randomization (Day     0). Eligible subjects were randomised to Clobetasone Butyrate 0.05% Cream group or vehicle     (cream base) group at the rate of 1:1. During the treatment phase, subjects returned to the     sites in day 7 post-baseline visit for assessment of their disease status and eligibility to     continue on the study. During the final visit, 14 days after the baseline, subjects returned     to the study sites for assessment of their disease status before completing the study. In     addition, the safety and tolerability of Clobetasone Butyrate 0.05% cream were also assessed     through the whole trial.   "
131180|NCT01567982|"     We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal     symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.   "
131181|NCT01567969|"     The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate     the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS)     intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children     at risk of a psychiatric inpatient admission and their families. Children and families are     randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a     home-based case management intervention for coordination of mental health services for     children. Approximately 144 children and their families will be enrolled for a 12 month study     period. Data will be collected through interviews with the child's parent/legal guardian, and     from the child's teacher, the child's school, and the Department of Social Services (claims     data). This study will test the hypotheses that children receiving IICAPS will be less likely     to exhibit out-of-control behaviors and less likely to experience a psychiatric     hospitalization and/or out-of-home placement during and up to six months post-discharge from     services.   "
131182|NCT01567956|"     The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine     modified release tablets 1g/die in reducing the symptoms of the disease with respect to the     proportion of patients with disease remission at the end of the 8 weeks of treatment. It will     also aim to investigate capability of the treatment in the maintenance of remission after     four weeks of treatment interruption; histological changes will be also evaluated and     finally, improvement in the overall quality of life as measured by the Short Inflammatory     Bowel Disease Questionnaire (SIBDQ) will be investigated.   "
131183|NCT01567943|"     The investigators will evaluate the efficacy of a comprehensive 12-week contingency     management intervention for treating alcohol dependence for persons with severe mental     illness who are seen within the context of a community mental health center setting. The     primary contingency will be submission of alcohol-free urines. Additional reinforcers will be     provided for intensive outpatient addiction treatment attendance. Reinforcers will be     vouchers or actual items useful for day-to-day living. Participants will be 120 adults     diagnosed with alcohol dependance and severe mental illness.   "
131184|NCT01567930|"     The purpose of this study is to evaluate the activity of temsirolimus in patients who have     advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy     or biologic therapy like sorafenib, but have experienced disease progression or intolerance     to that therapy.   "
131185|NCT01567917|"     Venous thromboembolism (VTE) has harmful effects on morbidity and mortality of cancer     patients. In Western VTE guidelines, all solid cancer patients receiving abdominal major     surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such     as low molecular weight heparin (LMWH) in the perioperative periods. These recommendations     are based on the high incidence of postoperative VTE development in Western cancer patients.     However, there have been many cumulative data about the effect of different ethnicity on the     VTE development and more and more investigators and clinicians admit that Asian ethnicity has     lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply     Western guidelines as it is to the clinical situation of Asian cancer patients.      Although colorectal cancer (CRC) is one of the common cancers and the incidence is rapidly     increasing in Asia, there have been few prospective data on the incidence of VTE development     during the postoperative period in Asian CRC patients. To our knowledge, there have been a     few small-sized prospective studies in Asia and thus clear conclusions could have not been     drawn based on those studies. Most Korean colorectal surgeons think that the incidence of     postoperative VTE development is very rare based on their own clinical experiences. They also     have much concern about the complications such as bleeding that might be caused by routine     use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore, in most     clinical situation, many Korean colorectal surgeons do not perform perioperative     pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Asia     including Korea, the uncritical acceptance of Western guidelines may be inappropriate. The     necessity of pharmacologic thrombo-prophylaxis can be answered only from our own prospective     study on the incidence of postoperative VTE development after CRC surgery. Moreover, current     surgical trend in cancer patients is minimally invasive approach such as laparoscopic     surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving     laparoscopic cancer surgery has not been evaluated even in Western countries. Western     guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really     necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds,     this study was designed.   "
131186|NCT01567904|"     Primary Objective:      - To assess the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of Semuloparin     [AVE5026] (assessed from the anti-Xa activity of Semuloparin) in children in order to     determine the dose to be assessed in a clinical efficacy/safety study in this population.      Secondary Objective:      - To assess the tolerability of Semuloparin when administered at a weight-adjusted, once     daily dose for up to 30 days in patients less than 18 years of age with central venous line.   "
131187|NCT01567891|"     This study, will take a subject's T cells and teach them to be able to recognize and     attack the ovarian cancer cells. This is done by putting in a gene or genetic material that     will change how a subject's T cells work and hopefully get them to attack and kill ovarian     cancer cells. These new T cells are called engineered T cells because the new gene is     causing them to become directed toward the ovarian cancer cells rather than their usual     targets. These are also called gene-modified T cells. For subjects who have the HLA A2     tissue-type marker, the T cells would be engineered to recognize a substance called     NY-ESO-1. After putting this new gene in T cells (a procedure called gene therapy) the     investigators will grow the cells in the laboratory and give these cells back to subjects.   "
131188|NCT01567878|"     -  Evaluate the correlation of ultrasound MASEI index with clinical, functional,          radiographic and laboratorial variables in patients with ankylosing spondylitis.        -  Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound          (synovitis, erosions, power doppler) with same variables.        -  Evaluate correlation between articular and enthesis ultrasound exam in this study.        -  Compare patients and healthy individuals data, to calculate the ROC curve to estimate          predictor value of disease.   "
131189|NCT01567865|"     The proposed JEV05 study is a four-arm double-blind randomized controlled single center trial     to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency     of three lots of JE live attenuated SA 14-14-2 vaccine manufactured in a new GMP facility,     and to establish non-inferiority of the new vaccine in comparison to a single lot of the same     vaccine manufactured in the existing facility. The study will enroll a total of 1,000     Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05     will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi     children. This will be the first step to secure licensure for this life-saving vaccine in     Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA     14-14-2 vaccine.   "
131190|NCT01567852|"     When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter     using ketamine for induction than using methohexital.   "
131630|NCT01562080|"     The aim of this study is to demonstrate whether, along with dietary recommendations,     Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a     change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III     (ATP III)   "
131191|NCT01567839|"     Infiltration (injecting next to the tooth) injections are common in dentistry and a number of     studies have shown that articaine anesthetic, when injected next to the tooth as a     supplemental injection, works very well following a typical inferior alveolar (lower jaw)     nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine     with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower     jaw) infiltration injections of the first molar. The purpose of this prospective, randomized,     double-blind, crossover study is to compare the degree of anesthesia obtained from the three     solutions as a primary infiltration injection next to the mandibular first molar. The     investigators also will record the pain of injection and postoperative pain.   "
131192|NCT01567826|"     The study will assess the regression of yellow plaque content of the lipid pool after     aggressive lipid therapy by utilizing NIR spectroscopy. Statin therapy using Rosuvastatin     10-40 mg will be compared to the statin therapy of either Atorvastatin or Simvastatin. This     is a single site study. A total of 100 subjects will randomized, of which 40 will receive     intensive lipid therapy (Rosuvastatin 40mg) and 40 will receive standard care lipid lowering     therapy.   "
131193|NCT01567813|"     This is a post-licensure safety observation cohort study to describe the general safety of     GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.   "
131194|NCT01567800|"     The purpose of this study is to look for low levels of oxygen (hypoxia) in prostate cancer     using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have     an effect on how prostate cancer grows and responds to treatments like radiotherapy and     chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the     methods used previously.   "
131195|NCT01567787|"     The purpose of this study is to determine if Proton Therapy can provide effective and safe     treatment for Malignant Peripheral Nerve Sheath Tumors of the spine and Neurofibromas of the     spine.   "
131196|NCT01567774|"     Patients with coronary artery disease (CAD) are often treated with dual antiplatelet therapy     (DAT), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events.      Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment     with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel.      Atorvastatin and simvastatin are metabolized by CYP3A4 [Clin pharmacokinetic 2002; 41:     343-70], whereas the cytochrome P450 mediated metabolism of rosuvastatin appears to be     minimal and principally mediated by the 2C9 isoenzyme, with little involvement of CYP3A4     [Clin Ther 2003; 25: 2822-5.].      Previous studies comparing atorvastatin versus rosuvastatin by means of ex vivo platelet     function tests have yielded conflicting results.   "
131197|NCT01567761|"     The purpose of this study is to examine whether the intraocular pressure of operated people     under general anesthesia is affected by the artificial respiration method. If it is proven     that there is such influence, the findings may lead to select the best method for patients     with increased intraocular pressure.      In this study, the investigators will monitor the changes observed in intraocular pressure     caused during an operation in two different artificial respiration methods:        1. Intermittent positive pressure ventilation (IPPV)        2. High frequency jet ventilation (HFJV)      Study recruited 50 patients aged 18 - 40, candidates to elective orthopedic surgery in the     limbs. These patients do not suffer from general diseases that restrict their daily     functioning.      The selection of the type of surgery was done to prevent the involvement of any other factor,     except the respiration method, determination of intraocular pressure.      Exclusion Criteria:        -  Patients who are unable to provide an Informed Consent        -  Patients suffering from any eye disease        -  Patients with corneal thickness less than 450 microns or more than 600 microns        -  Smokers        -  Patients with pulmonary disease restrictive or obstructive        -  Patients using bronchodilator      All patients operated under general anesthesia using total intravenous anesthesia )TIVA)     method.      All patients will be resuscitating half of the time of surgery using IPPV, and in the second     half of surgery using HFJV.      During the surgery the IOP will be measured by an ophthalmologist who is unaware of the     respiration method.      Correction will be made to the intraocular pressure values, depending on the thickness of the     cornea.      The results of the measurements will be collected and the clinical significance will be     reviewed by acceptable statistical methods.   "
131198|NCT01567748|"     Central aortic blood pressure (BP) and flow are generally more informative about the health     condition of the heart and the arterial system compared with BP measured in peripheral     locations (e.g. arm or leg). However, their clinical impact has been limited due to the cost,     risk and discomfort associated with their measurements. Peripheral BP is attractive because     it can be measured relatively easily than central aortic BP. However, peripheral BP is not as     useful as central aortic BP since the shape of its waveform is different from that of central     aortic BP. The applicant recently developed two innovative methods, the Individualized     Transfer Functions (ITF), which is able to estimate the central aortic BP waveform of a     patient using the measurements of peripheral BP waveform(s). The methods were successfully     validated using animal and simulated human subjects. The objective of the proposed research     project is to examine the validity of these innovative methods in human subjects.      Cardiovascular disease accounts for 1/3 of all deaths and more than $22 billion     healthcare-related cost in Canada every year. The proposed research project will make     significant contribution in improving clinical care by the potential of ITF in detection and     diagnostics of cardiovascular disease. In fact, the proposed research project is a key     initial step towards our long-term research objective of non-invasive cardiovascular disease     diagnostics. The success of the proposed research project will demonstrate that ITF can serve     as a low-cost, non-invasive and convenient alternative for central aortic BP measurement,     which can further be used for the development of detection and diagnostics methods for a     number of cardiovascular diseases (e.g. aortic valve impairment and peripheral arterial     disease) by virtue of the relevant health and disease conditions of central and peripheral     arterial vessels that ITF can deliver.   "
131199|NCT01567735|"     The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in     combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both     treatment-naïve and treatment experienced, chronic hepatitis C (HCV) virus, genotype-4     infected patients.   "
131777|NCT01560143|"     If tigecycline clearance increases with body size then serum exposure values will be lower in     obese class III compared to normal weight subjects because exposure changes inversely with     clearance when the dose is fixed without regard to weight.   "
131202|NCT01567696|"     The purpose of this study is to more fully understand the reason(s) that joint replacement     implants fail and to better identify diagnosis and outcome methods both pre-operatively and     post-operatively with revision surgery. Analysis of joint replacement failure will include a     through analysis of laboratory, radiographic, implant, surgical and demographic data.   "
131203|NCT01567683|"     This study is designed to assess the tolerability of test product and vehicle in terms of     skin reactions during repeated topical applications on healthy skin under controlled     conditions on the basis of the international guidelines for testing of skin irritations (FDA     Guidance for Industry (1999)).   "
131204|NCT01567670|"     The investigators are studying a new treatment for one subtype of obesity. Obesity is not a     disease. It is a symptom of several different diseases. These diseases have distinct     etiologies, being caused by aberrations in different mechanisms. Forms of obesity caused by     such non-critical mechanisms might be corrected fairly easily and safely. The investigators     are interested in overeating and obesity that is caused by the opioidergic system. The     opioidergic system appears to be responsible for a subtype of obesity associated with binge     eating disorder (BED). People, especially with the right genetic predisposition, can become     addicted to foods that release endorphins, in the way that people become addicted to     exogenous opiates and other drugs that release endorphins. The particular application in our     proposed clinical trial is for intranasal (IN) naloxone. The peak levels of naloxone were     similar and the bioavailability of naloxone intranasally was 100% (the same) of that     available IV. IN administration of naloxone has since been broadly tested in humans, as     well, where it has been shown to be safe, with pharmacokinetics similar to those of naloxone     given by injection .   "
131205|NCT01567657|"     The purpose of this study is to determine whether sedation with a combination of pethidin     hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in     relation to blood pressure drops during an transesophageal echocardiographic examination     (TEE).   "
131206|NCT01567644|"     Low intensity shockwaves have been proven in animal studies to induce local growth of new     blood vessels from existing ones.      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.   "
131207|NCT01567631|"     The purpose of this research is to compare the classical procedure with intrahepatic     Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and     limitations were assessed objectively through our clinical prospective study. The     investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's approach     is safe, effective and feasible.   "
131208|NCT01567618|"     This is an open-label, phase II study to evaluate the efficacy and safety of biweekly     docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line     therapy.   "
131209|NCT01567605|"     The main goal of this project is to determine the effects of lidocaine lubricant on     cardiovascular function during routine bowel care in individuals with spinal cord injury.     Bowel care is a common trigger of blood pressure and heart rate changes after spinal cord     injury. In this project, we will be measuring blood pressure and heart rate non-invasively     during normal bowel routine (which can be performed in the subject's home or at one of the     investigators facilities). The measurements will occur twice over a period of 28 days: once     using lidocaine lubricant and once using normal (placebo) lubricant. The recording equipment     will be attached and subjects will have complete privacy during their bowel routine. The     trial will be double-blind, meaning that neither the subject or the Nurse Continence Advisor     who assists with testing will know which lubricant is being used for each test.      The use of a lubricant gel containing an anesthetic is the standard of care in many hospital     facilities when performing bowel care for individuals with spinal cord injury; however, it is     not often used in the home setting. It is thought that using anaesthetic might reduce the     cardiovascular effects of bowel care after spinal cord injury. However, it is not known     whether this is the case.      The investigators hypothesize that the lidocaine lubricant will alleviate some of the blood     pressure and heart rate changes that occur during bowel care.   "
131210|NCT01567592|"     Low intensity shockwaves have been proven in animal studies to induce local growth of new     blood vessels from existing ones.      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients     with refractory angina not amenable to revascularization with angioplasty or bypass surgery.   "
131211|NCT01567579|"     The purpose of this study is to understand how having a heart problem affects     development,quality of life, and family life in young children and their families. Results     for children and families with heart disease will be compared to children and families     without heart disease. The investigators hope that this information may help us to support     children and families better in the future. All children and families that are seen in the     HHC Developmental Follow-Up Program will be asked if they would like to take part in this     study. It is hypothesized that children with congenital heart disease will demonstrate     developmental delays when compared to normative values.   "
131212|NCT01567566|"     The primary objective of this study is to compare the efficacy of two different exercise     programs for the reduction of pain and disability in a specific subgroup of NSLBP patients     and aims to investigate the additive effect of hip stabilization exercises. The investigators     hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (T2)     will be more effective in reducing pain and disability in NSLBP patients compared to the     local (segmental) stabilizer program (T1).   "
131213|NCT01567553|"     While significant progress has been made on medical imagery in recent years in the     individualization of different lesions in the nervous system for demyelination, axonal loss,     atrophy, little progress has been made in the specific recognition the inflammatory process.     Yet this point is essential since the currently available treatments have a partial impact     mainly on the inflammatory component and that many uncertainties remain about the links     between inflammation and tissue destruction affecting myelin and axons. The recent discovery     of a macrophage cell marker in the CNS, more specific (USPIO) of inflammation gives us the     opportunity to answer important questions which one can sense that this could have a     significant impact on therapeutic drug monitoring of these patients. This study will involve     50 patients recruited in five French centers (Marseille, Paris, Reims, Rennes, Toulouse) from     the earliest manifestations of the disease with clinical and MRI scheduled for the first 3     years of their disease.   "
131254|NCT01567007|"     The purpose of this study is to evaluate the impact of different types of intervention on     physical activity level and co-morbidities in women workers aged between 40 and 50 years.     Method: A total of 195 sedentary women aged between 40 and 50 years and those who agreed to     participate were randomized to one of the following interventions: GI = Control (n = 47), GII     = Individual counseling (n = 53), GIII = Counseling group (n = 48); GIV = physical training     set (n = 47). Were evaluated: Physical Activity level (steps number evaluated by a     pedometer), quality of life (SF-36), body composition (BMI, waist circumference and     bioelectrical impedance) and clinical variables (plasma glucose and blood pressure).   "
131214|NCT01567540|"     Hepatitis C infection is a major public health problem with nearly 175 million infected     individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously     resolve infection and 40-80% of chronically infected patients (numbers vary depending on     viral genotype) that receive pegylated-interferon-alfa2a/ribavirin therapy clear the virus     and are sustained virologic responders (SVR). Still for many, the virus manages to circumvent     natural immunity and current therapeutic strategies, resulting in significant morbidity and     mortality.      To better define the distinct clinical outcomes of HCV infection many investigators have     performed candidate molecules screens or transcriptional profiling in order to identify     correlates of viral clearance. One molecule that has gained significant attention is CXCL10     (also known as interferon-gamma induced protein-10 or IP-10) as an important negative     prognostic biomarker. Given that CXCL10 is produced by hepatocytes and mediates     chemo-attraction of activated lymphocytes expressing the CXCL10-receptor, CXCR3, it is     counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness.      The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in     situ, resulting in the generation of an antagonist form of the chemokine. Based on the use of     specific inhibitors, the investigators now propose to test whether protection of the agonist     form of CXCL10 will increase responsiveness to peg-IFN-alfa2 / ribavirin therapy. This can be     achieved using DPPIV inhibitors, targeting the enzyme responsible for N-terminal truncation     of CXCL10. If safety is confirmed, the efficacy of DPPIV-inhibition in HCV patients will be     tested in future trials that examine potential clearance benefits.   "
131215|NCT01567527|"     This will be a randomized, double-blind, placebo-controlled trial to assess the time to     recurrence of any mood episode in subjects with bipolar I disorder who have maintained     stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and     female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder,     according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric     Interview (MINI), who have experienced at least one previous manic episode of sufficient     severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic     agent in addition to their current manic episode. All subjects must be experiencing a manic     episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both inpatients     and outpatients are eligible for this trial.      This trial will consist of a screening phase followed by 4 treatment phases. Subjects will     undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy     phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM     depot stabilization phase, and, a double-blind, placebo-controlled phase.   "
131216|NCT01567514|"     The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on     risk of pulpal complications in deep occlusal cavities with resin-based restorations.   "
131217|NCT01567501|"     This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this     study is to assess the bioequivalence between Test Product and the corresponding Reference     Product under fed condition in normal, healthy, adult, human subjects.   "
131218|NCT01567488|"     The underlying hypothesis of the synergistic activity of octreotide and everolimus is based     on the combination of a) a direct action of everolimus over mTOR (mammalian target of     rapamycin), and b) the inhibitory effect of octreotide on the IGF-I (insulin like growth     factor 1) system preventing the activation of the mTOR system by this factor. Both types of     inhibition would completely cancel this signal transduction pathway, which is so important in     neuroendocrine tumours.      Furthermore, the biological study proposed in this protocol will allow for better     establishing the relationship between the activation of the IGFR-PI3K-mTOR signal     transduction pathway (i.e., the mTOR pathway stimulated by IGFR) and treatment response; this     information is relevant since the IGFR-PI3K-mTOR activation status could be a response     prediction factor.      This study will provide significant additional information about the efficacy of the     combination treatment of everolimus with octreotide LAR® in non-functioning GI NET.   "
131219|NCT01567475|"     This study is an open label, multicenter study with two phases:        -  Phase I is a dose escalation study of RAD001 in combination with one injection of          Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive          non-Hodgkin's lymphomas to determine the dose limiting toxicities (DLTs) and maximum          tolerated dose (MTD). The purpose of the study is to assess the feasibility of the          combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug          interaction (DDI).        -  Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination          at the RP2D in patients with lymphomas.      Patients with lymphomas will be treated at the RP2D established during phase I and evaluated     for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR)     and stable disease (SD), and time to progression using the IWG criteria for treatment     response.      Induction therapy will follow the same schedule than during the phase I study.      Maintenance therapy: Monthly cycles for up to 2 years with:        -  Daily RAD001 at the same dose than during induction therapy.        -  Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual          maintenance schedule for Rituximab.      Response to therapy will be assessed between day 42 and day 49, then every two months.   "
131242|NCT01567163|"     The purpose of this study is to assess the effect of concomitant ramucirumab on the     pharmacokinetics of docetaxel in participants with advanced malignant solid tumors.      Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to     schedule will be replaced for the purpose of analysis; these participants may continue to     receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles     1 and 2.   "
131220|NCT01567462|"     The purpose of this study is to compare the uses of two types of equipment during     transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the     monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These     two devices do the same task but differ in the way they create electric current when removing     cancerous tissue. The investigators hope to examine and compare the uses of these two     surgical devices to see if any advantages do exist or whether they actually are similar. The     goal of the study will be to prove similarity in outcomes between the two techniques and     analyze the outcomes resulting from each case.   "
131221|NCT01567449|"     The purpose of this study is to examine the risk factors for aneurysm rebleeding.   "
131222|NCT01567436|"     Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy     as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007),     based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported     a protective effect of about 60%   "
131223|NCT01567423|"     In the Democratic Republic of Congo (DRC), malaria is an important cause of morbidity and     mortality. It is estimated that malaria is responsible for 30% of admissions to hospital     averaged throughout the country and for 25-30% mortality in children under five.      In 2005, DRC adopted artesunate and amodiaquine (ASAQ) as first-line anti-malarial treatment.     As WHO recommended that the efficacy of antimalarial drugs was monitored regularly to avoid     an upsurge of mortality and morbidity due to continued use of ineffective drugs, a     randomized, non-inferiority open-label trial was conducted in Katanga, in order to compare     the efficacy of the fixed-dose formulation ASAQ versus artemether-lumefantrine (AL),      Children aged six and 59 months with uncomplicated Plasmodium falciparum malaria were     enrolledand randomly allocated into one of the two regimens. The risk of recurrent     parasitaemia by day 42, both unadjusted and adjusted by PCR genotyping to distinguish     recrudescence from new infection, was analysed.      Between April 2008 and March 2009, 301 childrenwere included: 156 with ASAQ and 145 with AL.     No early treatment failures were reported. Among the 256 patients followed-up at day 42, 32     patients developed late clinical or parasitological failure (9.9% (13/131) in the ASAQ group     and 15.2% (19/125) in the AL group). After PCR correction, cure rates were 98.3% (95%CI,     94.1-99.8) in the ASAQ group and 99.1% (95%CI, 94.9-99.9) in the AL group (difference -0.7%,     one sided 95%CI -3.1). Kaplan-Meier PCR-adjusted cure rates were similar. Both treatment     regimens were generally well tolerated.      Both ASAQ and AL are highly effective and currently adequate as the first-line treatment of     uncomplicated falciparum malaria in this area of Katanga, DRC. However, in a very large     country such as DRC, and because of possible emergence of resistance from other endemic     regions, surveillance of efficacy of artemisinin-based combination treatments, including     other evaluations of the resistance of ASAQ, need to be done in other provinces.   "
131224|NCT01567410|"     The purpose of this study is to determine wether e-learning is a more effective than     traditional classroom teaching at norwegian nurses ability to use the Braden risk assessment     scale and pressure ulcer classification.   "
131225|NCT01567397|"     Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to     randomised controlled studies.While such studies are essential to determine efficacy and     safety of the product (usually compared to placebo), they provide no information on the     effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality     of life and other patient-related outcomes) in the typical real-life setting under clinical     practice conditions.Thus, the present study aims to collect data on the        -  Drug utilization of Microbial Collagenase in the hand of physicians, with focus on          feasibility, treatment patterns, and effectiveness in clinical practice        -  Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant          treatment, follow-up therapy)        -  Effectiveness (with focus on functionality)        -  Tolerability        -  Patient-related outcomes: patient satisfaction, health-related quality of life        -  Physician satisfaction with therapy        -  Resource utilization (hospital stays, drug consumption, concomitant medication etc.)        -  Long-term outcomes   "
131226|NCT01567384|"     The purpose of the study is to test the safety of an experimental drug called OSI-906 when     combined with pemetrexed at different dose levels and to find out the optimal doses of the     two drugs that can be given as a combination. Pemetrexed has been widely used for treatment     of certain solid organ tumors and is effective and approved for use in treatment of lung     cancer and mesothelioma.   "
131227|NCT01567371|"     This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid     monitor) during a period of phlebotomy and graded blood loss in patients who are having     cardiac surgery.   "
131228|NCT01567358|"     The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in     patients with Rheumatoid Arthritis inadequately treated with Methotrexate.   "
131229|NCT01567345|"     The aim of this study is to compare intrathecal morphine administration: using a pump with     continuous or programmable flow.   "
131230|NCT01567332|"     Recovery of neurological deficits after stroke results from a reorganization of cortical     activities, possibly through brain plasticity. Repetitive Transcranial Magnetic Stimulation     (rTMS-MagproR30) produces changes in cortical excitability, generates phenomena of     neuroplasticity. Its use to improve function after stroke, particularly of the upper limb,     was validated. The investigators propose to evaluate in a prospective pilot against placebo,     the benefit of rTMS at low frequency (1Hz) on the unaffected hemisphere in the short and     medium term, especially on walking function and spasticity in patients with sequelae of     cerebral infarction in the MCA territory with gait disturbance and motor weakness of the     upper limb.   "
131243|NCT01567150|"     This study is being conducted to characterize the way leg wounds respond to a new type of     wound dressing, compared to wounds in patients who are not using the new dressing. The     investigators will collect wound fluid for biochemical analysis, and they will measure the     wound healing that occurs with and without the new dressing.   "
131244|NCT01567137|"     Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in     detecting, localising and characterising satellite lesions in relation to an index breast     tumour in order to improve definition of clinical target volume after local excision.      Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for     localising unsuspected multifocal and multicentric lesions in women diagnosed with early     breast cancer.   "
131276|NCT01566721|"     This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and     tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in     participants with early HER2-positive breast cancer following tumor excision. Participants     will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an     assisted administration using a conventional syringe and needle/vial formulation (Cohort A)     or with assisted and self-administration using a single-use injection device (SID) in     selected participants (Cohort B).   "
131231|NCT01567319|"     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic     and non-allergenic components. Many factors such as the biovariability, differences in     extraction process and subsequent handling of allergens can affect the final composition,     potency, and stability of allergen preparations. Genetic diversity of affected people adds     another level of complexity. In order to control variability and to achieve consistency and     reproducibility for optimal safety and sensitivity/specificity, it is essential to     standardize the amount of allergen used in prick tests. Therefore, the system for biological     standardization mainly used in Europe still is the biological calibration of in-House     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines     as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT)     value. The aim of this procedure is to estimate the biological activity of allergen extracts.     The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a     specific skin reaction with a wheal of the same size as a wheal provoked by reference     histamine at a concentration of 10 mg/ml, when both solutions are administrated using the     same technique (prick testing) on at least 20 individuals who are sensitized to the allergen     concerned.      The present study aims to standardize the allergen extracts of Dactylis glomerata, Lolium     perenne, Secale cereale y Olea europaea by using this method.   "
131232|NCT01567306|"     Based on EMA (European Medicines Agency) new guidelines on the clinical development of     products for immunotherapy for the treatment of allergic diseases the aim of this study is to     establish a dose-response relationship for clinical efficacy of Phleum pratense pollen     extract subcutaneous vaccine.   "
131255|NCT01566994|"     If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement     Therapy and Transtheoretical tailored interventions produces an increasing treatment     trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and     population cessation generally. These recruitment and intervention strategies require limited     resources from health care providers and could be readily disseminable to other health care     systems for application with populations of smokers, especially unmotivated smokers who have     been understudied and underserved.   "
131233|NCT01567280|"     The study design consists of a cross-sectional survey on the clinical characteristics of     patients with asthma and their level of asthma control and current quality of life, and on a     prospective evaluation of the rate of switch from the uncontrolled/poorly controlled     condition to the status of controlled asthma. Asthma control will be based on the Asthma     Control Questionnaire scoring system, that has been fully validated for use in both clinical     practice and clinical trials and has strong discriminative properties which means that it can     detect small differences between patients with different levels of asthma control and it is     very sensitive to within-patient change in asthma control over time.      Quality of life as a reflection of the control of the disease, will also be evaluated by     means of the Mini Asthma Quality of Life Questionnaire scoring system.   "
131234|NCT01567267|"     The purpose of this study is to identify the effect of a short term educational intervention     for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good     Scientific Practice (GSP) to high-school biology students.   "
131235|NCT01567254|"     Background: Pediatric patients with type 1 diabetes mellitus are known to be a challenging     group for achieving recommended glycemic control. Coping with the demands of self-managing     IDDM in children and adolescents can be a formidable task, requiring a healthy and balanced     diet, monitoring and regular insulin injections. Most patients are non-compliant to the     treatment. A number of controlled studies have examined the efficiency of psychosocial     interventions for improving compliance and glycemic control among diabetic youth. None has     examined the effectiveness of guided imagery in treatment of type 1 diabetes mellitus.      Primary Objective: To asses simultaneously the effect of listening to auditory guided imagery     and blood glucose variability, compared to variability in blood glucose while listening to     songs.      Secondary Objective To assess the effect of routine auditory guided imagery to glycemic     control and quality of life in children with type 1 diabetes mellitus, compared to listening     listening to songs.      Methods:      Subjects: 14 youth ages 7-16 years with type 1 diabetes mellitus , for at least 6 months, and     not during the honey moon period will be recruited, and will be blindly randomized to receive     intervention (auditory guided imagery group) or control (regular auditory music).      Protocol:      Design: A randomized Controlled Blinded Study Intervention: 14 randomly numbered CD's will be     prepared at study initiation, half containing auditory guided imagery and half containing     music.      Study protocol: After an initial check up, including HbA1C levels, and explanation of study     procedures the participants will be given either the intervention or the control CD, to be     used twice a day for five days. During this period continuous glucose monitoring will be     performed. On days one and five the procedure will take place while the participants are     connected to biofeedback. QOL questionnaires will be completed at the beginning of day one,     or before.      In the second part of the study the children will use the intervention / control CD at home     twice a week for 12 weeks. At the end of the study period they will again be evaluated,     including HbA1C, and all subjects will again complete QOL questionnaires   "
131236|NCT01567241|"     Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction     techniques are required?   "
131237|NCT01567228|"     Physician counseling for physical activity, dental services, and academic support services     such as tutoring could be improved through physician knowledge of local community resources     and physician counseling directing patients to such services that are near the patient's     residential address. This study will test the hypothesis that an electronic medical record     enhanced with geographic information systems can improved physician counseling for physical     activity, dental services, and academic support services by identifying services that are     near the patient's residential address and informing MD's of such info at the point of care.   "
131238|NCT01567215|"     The investigators want to show that steroid creme and even better alcohol swaps are just as     effective or equal to the current treatment with silver nitrate of granuloma umbilical in     newborns.   "
131239|NCT01567202|"     This is a Phase II study in a single center to determine the efficacy of autologous dendritic     cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as a     vaccination in adults with glioblastoma multiforme (primary or secondary).   "
131240|NCT01567189|"     The hypothesis is that home based clinical rehabilitation (CR) is less expensive than     hospital based CR with similar clinical effectiveness. The investigators will compare the     results of two forms of CR on        1. direct and indirect healthcare costs        2. effectiveness on mortality, morbidity, modifiable risk factors control, functional          capacity measured by exercise testing, health related quality of life and satisfaction          rate        3. cost/effectiveness analysis   "
131241|NCT01567176|"     This study follows the results of the COMPALICLAMP study (NCT00951392) where the     investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle     depending on the quality of aging. The investigators seek to confirm this difference in     expression level of circulating leukocytes on a larger sample.   "
131256|NCT01566981|"     The purpose of the study is to clinically evaluate a new approach to treatment of patients     with diabetes mellitus type II by using specially developed mobile-internet software     solution.      The effect of information and communication technologies (ICT) to improve the integrated care     of people with diabetes will be identified, developed, introduced and clinically evaluated.      The investigators expect that usage of an e-Health application in health care of patients     with diabetes mellitus type II could improve the following healthcare outcomes: results of     the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure     values, Body mass index (BMI) values, diet, regular exercise and quality of life.   "
131582|NCT01562704|"     Paracetamol is one of the most widely used analgesic in the world, indicated for the     symptomatic treatment of fever and pain. The objective of this study is to evaluate the     mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools     (functional MRI and test inducing pain by thermal stimulation.   "
131245|NCT01567124|"     The use of antipsychotic medications has increased over the past decade. While more recently     developed medications are improved with regards to extrapyramidal side effects, the use of     atypical antipsychotics has been associated with substantial weight gain and a worsening of     metabolic profile. The time course and extent of weight gain differs among antipsychotics,     with olanzapine and clozapine being associated with greatest weight gain.      Mechanisms underlying a worsening metabolic profile, obesity and obesity-related illnesses     are complex, extending beyond sedentary lifestyle, poor diet and genetic predisposition.     There is also a growing body of evidence that the sympathetic nervous system (SNS) has a role     in the generation of both obesity and obesity-related illness. While the role of the SNS in     blood pressure control is readily acknowledged it is less well appreciated that activation of     the SNS exerts profound metabolic effects.      Although the fact of a causal relation linking antipsychotic drugs and obesity is     unequivocally established, the biological mechanisms operating are unclear, and strategies     for preventive therapy remain largely unformulated.      This study aims to investigate the role of the SNS and its association with the metabolic     abnormalities that are frequently observed in patients with schizophrenia following treatment     with antipsychotic medications.      Additionally, the study will investigate whether treatment with the centrally acting     sympatholytic agent moxonidine will modify SNS activity and, hence, favourably influence the     downstream metabolic abnormalities seen in antipsychotic treated patients with schizophrenia.      Hypothesis 1: Elevated sympathetic nervous system activity underlies the metabolic     disturbances observed in patients following antipsychotic therapy.      Aim 1: To investigate the role of the sympathetic nervous system and its association with the     metabolic abnormalities that are frequently observed in patients with schizophrenia following     treatment with antipsychotic medications      Hypothesis 2: Central sympathoinhibition with moxonidine will blunt the elevated sympathetic     nervous activity and downstream metabolic abnormalities observed in antipsychotic treated     patients with schizophrenia.      Aim 2: Determine whether treatment with the centrally acting sympatholytic agent moxonidine     will modify sympathetic nervous system activity and, hence, favourably influence the     downstream metabolic abnormalities seen in antipsychotic treated patients with schizophrenia.   "
131246|NCT01567111|"     Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of     secondary hypertension. The diagnosis and targeted treatment of PA is essential because of     high vascular morbidity associated with PA as compared to essential hypertension with     comparable blood pressure levels. PA is usually caused by either a unilateral     aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction     between APA and BAH is critical since the former may be cured by adrenalectomy, and the     latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA).     Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s)     producing the most of aldosterone excess. The distinction between unilateral and bilateral PA     can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008     guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning     which does not distinguish between aldosterone-producing and common non-functioning adrenal     nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive,     dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive     functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).      Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary     objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar in     histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic     accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial     remission rates (blood pressure response expressed in Daily Defined Dosages, medical therapy,     use of potassium supplements) after allocating subjects to MRA-therapy or adrenalectomy at 1     and 5 years.   "
131247|NCT01567098|"     A randomized trial to study the null hypothesis: single incision appendectomy does not take     longer operation time when compared to conventional 3-port appendectomy. The study will be     carried out in a tertiary referral center in Hong Kong with a catchment population of 1     million.   "
131248|NCT01567085|"     Primary Objective:      To evaluate the safety and potential efficacy of eculizumab to prevent Antibody Mediated     Rejection (AMR) in sensitized recipients of deceased donor kidney transplants.   "
131249|NCT01567072|"     It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing,     but the knowledge is based only on animal studies, and the results are automatically raised     for the people.      Many patients with bone fracture must therefore avoid the formerly so popular and good     painkillers, although no clinical trial evidence is, that this medicine is really harmful for     patients with fractures.      The purpose of this study is to investigate whether these drugs slows bone healing, and what     the relationship is between various bone studies - DEXA scanning, biochemical bone marker     tests, radiographic controls and tissue examination of newly formed bone under a microscope.     How sensitive and specific, each of the above study methods? If they are just as sensitive,     the cheapest of them recommended as a routine investigation on suspicion of bone effects.     Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of     these drugs and their possible harmful side effects (affected and delayed bone healing).      The expectation is that the study may contribute to increased knowledge about NSAIDs effect     do pain management, rehabilitation and the entire treatment process significantly easier and     safer, so that patients recover faster and return to usual activities.   "
131250|NCT01567059|"     This study examines a new oral chemotherapy drug called tosedostat, in combination with     cytarabine or decitabine. Tosedostat is thought to work by decreasing the availability of     amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in     early studies to have activity against a variety of cancers, including leukemias. Patients     with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific     genetic mutations have a poorer response to chemotherapy and a higher risk of relapse after     treatment. Researchers are looking to see if combinations of chemotherapy drugs may improve     outcomes for patients that do not respond as well with the current chemotherapy regimens,     without increasing the risks of treatment.   "
131251|NCT01567046|"     This research trial studies genes in tissue samples from younger and adolescent patients with     soft tissue sarcomas. Studying samples of tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors find better ways to treat cancer   "
131252|NCT01567033|"     The purpose of this research study is to evaluate two different Parents as Teachers     curriculums taught by parent educators, during home visits. The control curriculum includes     only the standard PAT lessons; the intervention curriculum includes the standard PAT lessons     plus additional information about how families can live healthy and active lives while     reaching a healthy weight. The investigators hypothesize the intervention lessons will change     the way people eat and/or their activity level.   "
131253|NCT01567020|"     The current conflicts in Afghanistan and Iraq have resulted in unprecedented rates of     exposure to high-intensity blasts and resulting brain injury. This research team has     established that recently blast-exposed Soldiers show differences from controls on tests of     central auditory function. This project will 1) develop a more accurate estimate of the     prevalence of central auditory dysfunction among Veterans exposed to blasts over the past ten     years, 2) identify the functional outcomes associated with abnormal performance on tests of     central processing, and 3) improve understanding of the ways in which blast-exposure     resembles and differs from both the normal aging process and non-blast-related TBI in terms     of performance on tests of central auditory processing.   "
131583|NCT01562691|"     The purpose of this study is to determine the effect of integrated airway in nasal packing     material foe patients receiving nasal septoplasty surgery.   "
131257|NCT01566968|"     The sensitivity of a person's cough reflex can be measured by getting them to breathe in     (inhale) irritant chemicals. There are different methods by which subjects are asked to     inhale these chemicals, either by taking one deep breath in, or by asking them to just     continue to take a number of breaths. The purpose of this clinical research study is to see     if the coughing responses are different in healthy people and people with respiratory     problems that make them cough when they are given these chemicals in these two methods.   "
131258|NCT01566955|"     The main reason for this trial is to show the feasibility of removing the ovarien and     fallopian tubes through the gaster (transgastric adnexectomy). The background for it is to     look for more indications of scarless surgery and we will show that the transgastric     adnexectomy can be performed in an easy way. It is necessary that there is an indication for     removing the ovaries and fallopian tubes and if the patient agree we will do it instead of     through the belly through the gaster and maybe with an additional inzision in the vagina. All     patients with indication for adnexectomy are potential candidates.   "
131259|NCT01566942|"     the aim of this study is to observe the effect of irinotecan-based regimen in patients with     advanced colorectal cancer.   "
131260|NCT01566929|"     The primary aim of the study is to evaluate if weight management intervention for obese women     (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating     woman, as compared to women where no intervention was made.   "
131261|NCT01566916|"     This prospective, randomized study will study the 2 year survivorship and short term outcomes     of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two     surgical approaches. The surgical approaches being studied are direct anterior and     anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will     be compared. Subjects will be randomized to surgical approach and followed for a period of     two years.   "
131262|NCT01566903|"     MR angiography (MRA) has become essential in the treatment of neurovascular diseases,     including ischemic stroke - the first cause of disability in occidental countries, vascular     malformations such as aneurysms, arteriovenous fistulas and malformations, whose treatments     are improving year after year.      MRA is an alternative to digital substracted angiography (DSA), circumventing th use of     endovascular catheterism, irradiation and injection of iodinated contrast agent.     Contrast-Enhanced MRA (CE-MRA) with gadolinium injection is currently the reference standard     for vascular MR exploration but still presents many limitations inherent to the injection of     contrast medium. Hence, the synchronization of the acquisition with bolus contrast injection     limits the improvement of spatial and temporal resolutions and requires an accurate     synchronization of the acquisition with the arrival of the bolus.      Moreover, the acquisition can be repeated as required as it does not require any contrast     injection.      Besides, the increase in nephrogenic systematic fibrosis clinical cases, which would be     secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has     restricted the use of CE-MRA. More than 500 cases were described to date in the world.      Its occurrence is currently estimated around 4 % for patients in terminal chronic renal     insufficiency and its mortality around 30 %.      According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agent     (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST     *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30     ml/mn.      Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide     complete and non-invasive investigation of the vasculature, thus offering patients with     chronic renal insufficiency, as well as pregnant or nursing women a surrogate with no side     effects.      Moreover, the use of high field (3T) MR imaging offers improved signal to noise ratio.     Combined with the use of phased array coils and parallel imaging, new NCE MRA sequences can     achieve juxta-millimeter isotropic spatial resolution and temporal resolution of about 50 ms     close to those of cerebral DSA.      These sequences allow a joint hemodynamical and morphological assessment of lesions, both at     the cervical and cerebral levels, whether at diagnosis or during patient follow-up   "
131263|NCT01566890|"     Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to     change their shape from a round shape to a half-moon/crescent or sickled shape. Sickle-shaped     cells can cause problems by getting stuck in blood vessels, blocking blood flow, and can     cause inflammation and injury to important body parts. There are no specific treatments that     improve this condition and promote blood flow hindered by sickle cell blockages. Another big     challenge in managing sickle cell disease is that there are no good measures to determine     changes and improvements in blood flow.      Contrast-enhanced ultrasound is a technique currently used to detect blood flow in the heart,     muscles, and other organs. It is extremely sensitive and can detect blood flow in the     smallest of blood vessels. It would be very useful in helping healthcare providers know     whether treatment strategies are improving blood flow during sickle cell blockages.      The hypothesis is that contrast-enhanced ultrasound will be a feasible tool for determining     changes in blood flow of subjects with sickle cell disease.   "
131264|NCT01566877|"     The purpose of this study is to evaluate the safety and tolerability of healthy male and     female subjects with intravenous (IV) infusions of AVI 7288 compared to matched placebo in     and to evaluate the pharmacokinetics (PK).   "
131265|NCT01566864|"     The investigators have designed a three-part quality improvement intervention to 1) improve     the clinic-based measurement of blood pressure, 2) introduce a care management system to     promote self-management behaviors and rapidly titrate medications by algorithms developed in     accord with guidelines and 3) introduce an interactive, needs-based, longitudinal-provider     education system that promotes patient-centered care and provides practical examples of     patient-provider communication strategies. The intervention will occur at six clinics within     the metropolitan area of Baltimore, Maryland. The investigators will also describe clinic and     health system characteristics and measure their association with implementation (uptake),     success (improvements in blood pressure control and reductions in racial disparities), and     sustainability of the three-part intervention over 12 -24 months.   "
133073|NCT01543139|"     This proposed research is aimed to investigate the efficacy and safety of the creatine and     cytidine augmentation in treating bipolar depression and to evaluate changes in relevant     brain biochemical metabolism using magnetic resonance spectroscopy.   "
131277|NCT01566708|"     To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute     tinnitus drug treatments are only rated as being successful in approximately half of all     cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic approach     (the Heidelberg Model of Music Therapy) as a new treatment option for patients with recent     onset tinnitus after initial medical treatment has failed.   "
131266|NCT01566851|"     Introduction Cardiovascular diseases are the first cause of death in rheumatoid arthritis     (RA). In 2010, EULAR Standing Committee for Clinical Affairs provides 10 recommendations for     cardiovascular risk management in patients with rheumatoid arthritis, including a     cardiovascular risk assessment annually.      The goal of this study is to evaluate the application of EULAR recommendations in real life     in patients with RA in the french population. Inclusion criteria: all patients over 18 years     old with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy,     affiliated to the RSI (regime social des independents which correspond to other branches of     the universal healthcare insurance agency). Non inclusion criteria: patients declared as     rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone. The     following analysis will be performed on the whole database of the RSI, without name     identification. Evaluation criteria: at least once a years the prescription of at least one     of the following items use in the evaluation of the cardiovascular risk factors: lipides     dosage, glycemia, HbA1C, stress test, Carotid ultra-sonography, coronary or lower limbs     arteriography, heart ultra-sonography, cardiology clinic, endocrinology clinic. This     evaluation will be done on the whole national population of RSI for the year 2011 (01/01/2011     - 31/12/2011). On a subgroup of patients from the region Provence Alpes Côte d'Azur, the     investigators will analyze the year 2009, and compare to year 2011, to evaluate the impact of     theses recommendations.   "
131267|NCT01566838|"     Rationale: For the past 3 years the investigators have routinely used an axial subpleural     tunneling technique that del      Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure     performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened.     Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for     operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics,     drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease,     sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability     to consent, or are pregnant. All patients included will be screened, consented, and operated     on by the one year anniversary of institutional review board (IRB) approval.      Study Methodology: Eighty-six consented patients will be randomized into the study arm (use     of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter).     The primary outcome is the use of narcotic pain medication post-operatively, compared between     study groups. Secondary outcomes will include postoperative pain scores, hospital and length     of stay.      The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere,     creating a functional multi level rib block. Despite positive subjective results, objective     data is lacking. The investigators have also noted that some patients develop an annoying     short term paresthesia that has been minimized by using lower anesthetic concentrations than     described in other publications.      Objectives: To evaluate visual analog pain scores post-operatively up to 30 days     post-operative, and to determine any association between pain management and length of stay.      Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology:     Total amount of narcotic pain medication administered through postoperative day 7, will be     compared between the study groups using student's t-tests and Wilcoxon rank-sum tests.     Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30     post-operatively, hospital length of stay, and overall hospital cost, will also be compared     among study groups using student's t-tests and Wilcoxon rank-sum tests.   "
131268|NCT01566825|"     The purpose of this study is to determine whether 75 mg amitriptyline affect the sleep     dependent consolidation of procedural memory (visual discrimination task,     Karni-Sagi-paradigm).   "
131269|NCT01566812|"     This study aims to find out whether breast feeding optimization will increase breast feeding     rates and to evaluate its effect on cardiovascular risk and general health of children.   "
131270|NCT01566799|"     Background Obesity and overweight are well known risk factors for breast cancer and also are     associated with higher recurrence and mortality rates.      Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms     of pathologic complete response in comparison with placebo plus the same chemotherapy regimen     Design: Randomized, double blind, clinical trial. This study will be performed at National     Cancer Institute of Mexico City, at breast cancer unit.      Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.      After completion of chemotherapy all patients will have a breast surgery to assess pathologic     response.      Complete pathologic response is defined as the abscence of malignant cells in breast tissue     and lymph nodes. The presence of DCIS is considered as pCR   "
131271|NCT01566786|"     This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the     safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in     preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).   "
131272|NCT01566773|"     The overall objective of this study is to determine an optimal dose and dosing regimen of     PT001 MDI for further evaluation in later stage studies.   "
131273|NCT01566760|"     This is an open-label (both the physician and healthy volunteer know which medication will be     administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics     (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by     the body) and the effects of food on the pharmacokinetics of the drug. This study will take     place over approximately 8 weeks and will consist of a screening visit to determine     eligibility for the study, and 2- or 3-period treatment phase for each cohort.   "
131289|NCT01566552|"     The study is designed to determine the use of delivering point of care, rapid diagnosis with     rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary     Health Center (PHC) settings with regard to operational feasibility, safety and final cure     rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the     PHC level would bring the best available interventions closer to the patients with visceral     leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would     support the VL elimination program in the Indian subcontinent.   "
131290|NCT01566539|"     The project has three overall objectives. The first is to determine whether and how     administration of intranasal oxytocin (OT) and intranasal vasopressin (AVP) influence     cooperative decision-making and neural responses to cooperative and un-cooperative social     interactions. The second is to determine whether and how intranasal vasopressin influences     subjective evaluations of and neural responses to same and opposite-sex face stimuli and to     determine if any of these effects persist beyond the period of AVP exposure. The third     objective is to determine if intranasal OT influences empathy-related behavior and associated     brain activity.   "
131274|NCT01566747|"     This is a phase II open label, single arm study evaluating treatment with pazopanib post     sunitinib treatment in 43 patients with metastatic renal cell carcinoma. Patients will     receive 800mg pazopanib per day given continuously until disease progression. Patients must     have received treatment with sunitinib and relapsed. Patient must have received prior     treatment with sunitinib for at least 12 weeks. Prior treatment with either temsirolimus or     everolimus in addition to sunitinib is allowed. The trial design uses a Simons two stage     design with an interim analysis planned after the first 15 evaluable patients. If 8 or more     of the first 15 evaluable patients remains disease free at 4 months, then a further 28     patients will be enrolled for a total of 43 metastatic renal cell cancer patients. It is     estimated that there could be up to 10% of patients dropping out and so to achieve the     required number of 43 evaluable patients the study will recruit up to 48 patients to ensure     that 43 complete if stage 2 is required.      Patients will receive treatment until disease progression, unacceptable toxicity or     withdrawal of patient consent. Response assessments will be carried out every 8 weeks until     disease progression. Safety assessments will be carried out every 4 weeks (plus a visit for     liver function tests after 2 weeks) for the first six months and then every eight weeks until     disease progression. A further safety assessment will be carried out 4 weeks after treatment     discontinuation.   "
131275|NCT01566734|"     This study conducted to assess the effects of normal saline or cefazolin irrigation on the     incidence of SSIs.      Hypothesis:      Normal saline or cefazolin irrigation decreases the incidence of SSIs.   "
131279|NCT01566682|"     The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in     the risk stratification of patients with pulmonary lesions identified by CT that are     suspicious for lung cancer. A statistically significant result will indicate that patients     with a high ProLung Test result have a greater risk of developing lung cancer than patients     with a low test result.      There are three Specific Aims of this study:        1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in          patients with a diagnosis.        2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by          comparing the test result to the conclusive patient diagnosis.        3. Assess the safety and tolerability of the ProLung Test procedures.      Study Design This Study consists of two distinct phases, Stabilization and Validation. The     Study will collect data from multiple sites (3 to 12), and each site may enroll patients and     collect data for the Stabilization and Validation Phases with a minimum of three sites for     the Validation Phase.   "
131280|NCT01566669|"     The purpose of this study is to determine the effects of parecoxib in combination with     epidural morphine in providing analgesia for patients undergoing gynecological surgery.   "
131281|NCT01566656|"     Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to     reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities     associated with the transplant. Consequently non-relapse mortality has been reduced,     including in elderly patients with comorbidities. However, despite this benefit in terms of     toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the     initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal     and viral infections are always serious complications. The aim of our study is to check if a     new modality of reduced intensity preparative regimen combining total lymphoid irradiation     (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the incidence     of acute GVHD after allogeneic transplantation while preserving the antitumor benefit.   "
131282|NCT01566643|"     This prospective controlled randomized open-label clinical trial is designed to determine the     optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for     adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3,     5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin,     then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin +     metronidazole.   "
131283|NCT01566630|"     This study is designed in two parts. Part 1 will assess the safety and tolerability of     different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood     pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can     prolong pregnancy in women with pre-eclampsia.   "
131284|NCT01566617|"     The investigators hypothesize that pharmaceutical care may constitute an important tool for     the clinical management of these patients by improving their compliance to their treatment     with consequent improvement in their quality of life by minimizing symptoms, and decreasing     the number of hospital admissions and adverse drug reactions. Therefore, the aim of this     trial is to evaluate the contribution of pharmaceutical care to clinical treatment of     patients with Chagas heart disease complicated by heart failure.      Study Type: Interventional      Study Design: A total of 88 patients will be randomly assigned into two parallel groups: (1)     group who will receive standard care and pharmaceutical care; and (2) group who will receive     only standard care. Both groups will be subjected to a follow-up period of 12 months. The     primary outcome of this trial is the evaluation of quality of life, measured by the 36-item     short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes     include drug-related problems and exercise tolerance measured by the standard six-minute walk     test.   "
131285|NCT01566604|"     This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237     in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks     treatment.   "
131286|NCT01566591|"     The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS in     subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully     treated with antidepressant medications.   "
131287|NCT01566578|"     Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.   "
131288|NCT01566565|"     This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with     the primary objective of testing the safety and tolerability of combined oral doses of     theophylline and bambuterol in healthy human subjects. The secondary objective is to assess     the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in     combination. It is hypothesized that the combination of these drugs is generally safe, and     that no drug interaction can be observed.   "
131291|NCT01566526|"     The purpose of this study is to use retrospective data to evaluate the efficacy, safety and     re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein     occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs     Program.   "
131700|NCT01561157|"     The objective of this protocol is to conduct a longitudinal multidisciplinary investigation     of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and     mortality in people with these disorders.   "
131292|NCT01566513|"     The current study, through a randomized controlled design, will evaluate the effectiveness of     peer support, as compared to usual care and to an equivalent amount of support offered by     peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions     and in promoting recovery and community inclusion among adults with mental illnesses with     histories of multiple hospitalizations. The current study evaluates the cost-effectiveness of     adding peer support to the array of services available to persons with serious mental     illnesses who have histories of multiple hospitalizations and will test a theoretical model     of the active ingredients of peer support, focusing specifically on the roles of 1)     instillation of hope through positive self-disclosure; 2) role modeling of self-care and     exploring new ways of using experiential knowledge; and 3) a trusting relationship     characterized by acceptance, understanding, and empathy with conditional regard.   "
131293|NCT01566500|"     There is an urgent need to understand the psychological and situational factors that     influence medication adherence in individuals with epilepsy. According to the Center for     Disease Control (CDC, 2010) about 2.5 million people in the United States have epilepsy and     one third of them still have seizures despite receiving treatment. With proper medication, an     estimated 60-70% of individuals with new onset epilepsy become, and remain, seizure free     (Kwan & Brodie, 2000). Despite the success of medical treatment of epilepsy, many patients do     not receive these benefits due to inadequate adherence to medication (Meyer et al., 2010).     And, as with other chronic medical conditions, estimates suggest that between 30% and 60% of     patients with epilepsy are not adherent with their drug regimens (Green & Simons Morton,     1988; Leppik, 1990; Jones et al., 2006). Poor adherence may be the most important cause of     poorly controlled epilepsy (Gomes et al., 1998). Stanaway et al. (1985) found that 31% of     seizures were precipitated by nonadherence to medication.      Questions regarding adherence are theoretically informed by Fisher et al. (2006)'s     Information Motivation Behavioral Skills (IMB) model. While originally developed to describe,     predict, and inform interventions for antiretroviral treatment for human immunodeficiency     virus (HIV), this study applies the model to epilepsy for the first time. In addition, this     study intends to produce an accurate description of how individuals with epilepsy manage     their medication adherence by identifying current self regulation strategies (immediate     adherence behaviors, preparatory behaviors, and barrier management strategies) and their     situational determinants. Situational determinants can explain some of the fluctuations in     medication adherence. Patients who are motivated to take their medications might still show     inconsistent medication adherence. For example, patients might miss good opportunities to     take their medication or fail to anticipate unexpected barriers such as a spontaneous dinner     with friends or a bout of depression. Therefore, the study will take particular care to     investigate situational cues such as good opportunities for adherence (e.g., taking     medication with regular meals or before brushing teeth) and expected and unexpected barriers.     Preparatory behaviors and their cues are also of interest in this study: Some patients use     facilitators (such as physical or electronic reminder systems, electronic pill bottles and     pill boxes) to ensure adequate medication adherence. Social support can serve a similar     function of reminding patients to take their medication. To address these questions, the     investigators plan to explore how individual regulation and social support influence     medication adherence in patients with epilepsy. The specific aims of the proposed research     are:        1. To test the hypothesis that there will be a main effect of information, motivation and          behavioral skills, on adherence behavior, and that a mediation model will show that          information and motivation effects are partially mediated through behavioral skills.        2. To identify self regulation strategies and their situational cues (good opportunities,          facilitators, and barriers) for medication adherence among individuals with epilepsy to          better describe best practices and challenges.   "
131294|NCT01566487|"     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,     crossover, multicentric experimental bioequivalence study.   "
131295|NCT01566474|"     The study consists on determining whether melatonin decreases oxidative stress in Barrett's     esophageal mucosa after 6 months of treatment. In order to achieve the clinical trial, the     patients will be randomized to two possible arms: omeprazole alone or omeprazole plus     melatonin. The patients will be followed around four visits during six months.      GERD is one of the most prevalent pathologies in the digestive tract. Barrett's esophagus, a     complication of chronic GERD, has attracted the attention of researchers due to its condition     of pre-neoplastic lesion. At present, treatment of Barrett's patients is limited to acid     inhibition with PPIs. Although there are several studies which indicate that treatment with     PPIs could decrease the incidence of high grade dysplasia and EAC, treatment with PPIs does     not eliminate the risk of EAC in these patients. Therefore, it is necessary to find     chemo-preventive agents that stop neoplastic progression of Barrett's esophagus. Among them,     antioxidants have become the most promising agent. This pilot study will determine the     efficacy of melatonin in the chemoprevention of EAC.      So, the main objective of this study is to determine whether melatonin decreases oxidative     stress in Barrett's esophageal mucosa after 6 months of treatment.      To evaluate whether melatonin modifies other mechanisms associated to neoplastic progression     in BE patients: proliferation and apoptotic index and molecular markers of progression:     17pLOH, 9pLOH, p16 methylation and DNA ploidy (tetraploidy and/or aneuploidy).   "
131296|NCT01566461|"     The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral     drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral     arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.   "
131297|NCT01566448|"     Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when     chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of     patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of     the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because     the pain from mucositis can be so bad it can cause the inability to eat or drink, inability     to talk, gagging and drooling. Many times mucositis can affect cancer treatment because     patients may have to be given a lower dose of a drug or stop treatment completely. There are     not many treatments today that can help relieve the severe pain caused from mucositis. This     research study will help researchers determine if using an oral mouthwash called Ketamine     will help lessen mucositis pain.      Ketamine is approved by the Food and Drug Administration (FDA) for use with general     anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a     standard treatment option for mucositis pain.      During this study patients will be assessed to determine the level of pain caused by their     mucositis. This will occur before the first dose, one hour after the first dose, and then     daily until they are no longer on the study. Patients will use the mouthwash by swishing and     spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will     use the mouthwash on this study until their mucositis gets better or until the mucositis gets     worse (or if the pain does not get better after three days of treatment).   "
131298|NCT01566435|"     This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF)     consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel),     cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage     III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or     downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.   "
131299|NCT01566422|"     Despite the use of prophylactic systemic antibiotics and improved surgical technique,     surgical site infections remain a serious concern. The incidence of deep infection after     spine surgery has been lowered with systemic antibiotics, yet after instrumented fusion for     traumatic injuries infection rates remain as high as 10%. The impact on patients and cost of     treating such infections is profound. With diminishing healthcare dollars and policy that     refuses to reimburse for postoperative infections, it is critical that physicians and     hospital systems seek out cost effective ways of decreasing postoperative infections. Local     delivery of antibiotics into the surgical site have been found to significantly decrease     infection rates in those undergoing posterior spine fusion for traumatic injuries as studied     in a retrospective manner by the investigators of this grant. In this proposal the     investigators will prospectively randomize patients undergoing posterior spinal stabilization     for traumatic injuries into either receiving vancomycin powder into the surgical site     (treatment) versus not receiving vancomycin powder (control) and subsequently follow     infection rate, complications, and cost of care. The investigator's hypothesis is that i)     vancomycin powder will decrease infection rates ii) have no systemic toxicity iii) and be a     cost saving advancement in the safety of delivering spine surgical care.   "
131307|NCT01566318|"     Seniors who receive supportive services face a variety of psychosocial vulnerabilities that     put them at risk for depression. One group with very high risk is older adults receiving     aging services through Medicaid waiver programs. This 3-year research uses a randomized     controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem     solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent depression     in seniors receiving aging services.   "
131300|NCT01566409|"     Constipation is a common problem among children. The majority of children suffering from     constipation have no underlying disease. Although constipation has no basis in underlying     disease, it often leads to a reduced quality of life of children who are on par with or worse     than for children suffering from serious diseases such as cardiovascular and rheumatic     diseases.      Despite the high frequency of constipation among children, little is known about the causes     and treatment of constipation.      Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol     junior has proven very effective and are therefore widely used in children as disimpaction     and maintenance treatment. There is currently no research to prove the need for and length of     maintenance treatment with laxative medications in children.      The purpose is to examining the effectiveness of maintenance treatment with Movicol.     Additional til study will examine how the anal diameter change during a course of treatment     and the degree to which it can be used as an indicator of treatment efficacy.      The study will test the following:      • What is the effect of maintenance treatment with PEG compared to placebo?      The results from this study are expected to form the basis for an evidence-based approach to     the use of maintenance therapy and the use of ultrasound of the rectum in children with     constipation.   "
131301|NCT01566396|"     The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation     and resurfacing of the skin, and for the treatment of facial wrinkles. This study was     designed in order to evaluate the safety and efficacy of the A3F for treatment of facial     wrinkles.   "
131302|NCT01566383|"     The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between     ages, gender, race and different values of body mass index (BMI). This fact can cause new     modifications in the normal values such as making new scales for different age groups or BMI     groups.      Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never     experienced reflux related symptoms and are in between the same ranges of age and BMI of our     gastroesophageal reflux disease (GERD) patient population.   "
131303|NCT01566370|"     This is a randomized, double blind, placebo controlled trial of the medication zonisamide for     the purpose of reducing heavy drinking and drinking, as well as reducing mood symptoms, in     bipolar subjects that drink excessively and heavily.      Hypotheses: (Primary aims); Add-on zonisamide compared to placebo will result in:        1. significant reduction in heavy drinking days, drinks per week and per drinking day, and          significantly greater increase in abstinent days, ii) greater rates of abstinence and          abstinence to heavy drinking, greater reduction in biomarkers of heavy alcohol use such          as gamma-glutamyl transferase (GGT), and greater reduction in alcohol urge or craving,        2. Significant reduction in prevalent mood symptoms on the BRMS and BRMeS, CARS, HAMD, or          no worsening of euthymic mood, and significant improvement on the Clinical Global          Impressions Scale-Severity.        3. (Secondary aims) Add-on zonisamide compared to placebo will result in significant          reduction in weight (kilograms) and other secondary weight-related metabolic factors          such as fasting glucose, lipid profile, and blood pressure.        4. (Secondary aims) Add-on zonisamide compared to placebo will result in improved clinical          global impression, overall functioning, quality of life, and reduced medical symptoms.      5.) (Exploratory Aims) To will examine interactions between genotype and medication on     treatment response for allelic variation in genetic loci related to the major     neurotransmitter and neurophysiologic pathways that are relevant to bipolar disorder,     alcoholism, and zonisamide mechanism of action.   "
131304|NCT01566357|"     This in situ study aims to investigate        -  the protective potential of milk and fluoridated milk on erosive wear of enamel        -  the protective potential of milk and fluoridated milk on erosive wear of dentin        -  to compare to protective potential of milk and fluoridated milk with products containing          casein phosphopeptide-amorphous calcium phosphate        -  to compare the protective potential of milk and fluoridated milk with a fluoridated          toothpaste or stannous-chloride containing fluoride solution (SnCl2/AmF/NaF)   "
131305|NCT01566344|"     Frequent monomorphic premature ventricular complexes (PVCs) may cause a cardiomyopathy (CMP)     that is reversible by suppression of the ectopic focus. This study investigates whether PVC     suppression therapy can improve cardiac function and clinical condition of patients with     idiopathic or ischemic CMP and frequent monomorphic PVCs. For this purpose, patients will be     randomized to either one of two treatment strategies: 1) conventional heart failure therapy     plus PVC suppression therapy, consisting of RFCA as primary treatment and Amiodarone as     secondary treatment in case of unsuccessful RFCA, or 2) conventional heart failure therapy     without PVC suppression therapy.   "
131314|NCT01566227|"     This research is being done to find out the ideal number of implants/attachments required to     provide adequate stability of dentures during function.   "
131315|NCT01566214|"     The purpose of this research study is to survey patients to learn about their beliefs and     behaviors related to the management of heart disease and to discuss options for making     healthy lifestyle changes. From the information the investigators get from patients, the     investigators hope to develop better methods for taking care of patients who have heart     disease.   "
131316|NCT01566201|"     Inhibition of interleukin-1 (IL-1) activity in patients with RA without CAD ameliorates     vascular and LV function. Moreover, data from species shows beneficial effect of this     treatment on LV function after experimental myocardial infarction. The purpose of this study     is to investigate whether anakinra, an IL-1 receptor antagonist, improves vascular and left     ventricular (LV) function in patients with coronary artery disease (CAD) and coexistent     rheumatoid arthritis (RA).   "
131317|NCT01566188|"     The overall aims of the present project are to investigate the impact of a nutritional     approach based on omega-3 from vegetal origin on vascular function in hypertension associated     with metabolic syndrome.   "
131318|NCT01566175|"     The purpose of this study is to implant the Reducer in patients with the symptoms of     refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.   "
131306|NCT01566331|"     Safety of natural, vaginal labor for parturient, fetus and newborn is one of most important     goal among obstetricians, midwifes, scientific society all over the world. Maternal and     newborn clinical problems and complications following vaginal delivery cause a big amount of     medico-legal problems and high costs in the sanitary field.      Among the maneuvers that are used in the second stage of labor, uterine fundal pressure is     one of the most controversial and often diffuse in all over the world, generally not     documented, or under reported in medical records . Many Authors affirms that a different new     way to push may be of help. This maneuver was introduced by Kristeller, that in 1867 minutely     described a procedure to shorten, through the application of a pressure on the uterine fundus     whose intensity was quantified by a dynamometer and the duration measured in seconds, the     length of the second phase of the labor. Although uterine fundal pressure maneuver was     described by Kristeller as the placement of two hands on the uterine fundus and the     consequential application of longitudinal steady pressure at a 30- to 45-degree angle     directed toward the pelvis, with the avoidance of direct pressure toward the maternal spine,     there is no clear definition of the maneuver and no indication for its use has been formally     described to date.      The aim of this study was therefore to assess whether the use of the Baby-guardTM system,     through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of     biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure     during the second stage of labor in the direction of the pelvic outlet, may be of maternal     and fetus aid for a safe natural childbirth for their better outcomes.   "
131701|NCT01561144|"     The purpose of the study is to analyze the different patient profiles implanted with an     Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient     prognosis as a function of clinical profile, implant indication, arrhythmias incidence,     treatments or device programming.   "
131308|NCT01566305|"     Rationale and objective:      Based on the results of a pilot study, the objective of the present study is to evaluate     whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL     cholesterol raising effects of eggs.      Study Design:      The study has a randomized placebo-controlled factorial 2x2 design. The total study duration     is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period.     Subjects will be stratified for age, gender and BMI over the experimental groups.      Study population:      One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly     elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).      Intervention:      During the entire study period, volunteers are instructed to consume a diet according to the     Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During     the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk.     During the 12 weeks experimental period, a first group of subjects will continue drinking the     skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third     group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a     low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg     consumption (others than provided by us) is not allowed during the entire study.      Main study parameters/endpoints:      Measurements will be performed during the run-in period (days 0, 11 and 14) and during the     experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk     consumption) will be calculated as the absolute differences between values obtained at the     end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods.     The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary     endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and     hsCRP concentrations.   "
131309|NCT01566292|"     The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal     invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign     prostatic hyperplasia (BPH).      Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and     unsatisfactory response to combined medical therapy.   "
131310|NCT01566279|"     The investigators hypothesize that certain mutations in the individual cancer genomes will     predict response to Everolimus therapy. To identify possible genetic mutations that affect     tumor response to Everolimus the investigators will obtain sequence analysis of tumors from     all patients that will be treated with Everolimus in this study. Moreover, the investigators     performed a systematic review of the currently available data to identify mutations that     could be predictive for increased mTOR activity in cancer cells. These mutations have been     described to lead to mTOR activation but their predictive value for response to Everolimus     therapy remains unclear. The investigators will use the data generated in the investigators     own prospective treatment study and the data from literature to select patients for entry     into a second part of this trial. In this part the investigators want to test the hypothesis     that selecting patients based on their specific genetic mutations increases the likelihood of     response.   "
131311|NCT01566266|"     It is well known that metabolic responses to diet and drugs are affected by genetic and     environmental factors. Still, a large part of differences in responses between individuals     remains unexplained. To increase our understanding of individual differences, more and more     attention is paid to the role of intestinal microbiota. Not only energy and glucose may be     related to the microbiota, but also lipid metabolism. This is not surprising as lipid     metabolism, glucose metabolism, and obesity are closely linked.      There is substantial evidence from in particular animal studies that the gut microbiota is     related to lipid and lipoprotein metabolism. However, there is less evidence to what extent     modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.   "
131312|NCT01566253|"     C-section deliveries are painful and need adequate analgesia. In the same time, mothers need     early rehabilitation to take care of the baby.      Hypothesis: Early oral self administration of painkillers could be as effective as usual IV     administration by nursing staff.      Purpose of the study: Evaluation of the efficacy of a program of self administration of     painkillers postoperatively of C-section delivery.   "
131313|NCT01566240|"     Chemoradiation has been the standard treatment for advanced cervical cancer for a decade, but     one third of women still die from a failure to control systemic disease. In a recent     multicentre phase II trial of 46 women the investigators found that, 68% of women had tumours     that responded to weekly induction chemotherapy prior to chemoradiation. The induction     chemotherapy had acceptable toxicity and did not compromise the standard chemoradiation     treatment. In addition, the overall survival and progression free survival at 3 years was 66%     (95% CI 4779). These results, together with acceptable toxicity, provide justification for     evaluating induction chemotherapy prior to chemoradiation in a randomised phase III trial.     The investigators aim to investigate in a randomised trial whether additional induction     chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to     an improvement in overall survival. The investigators plan to recruit 770 women with locally     advanced cervical cancer who are eligible for standard chemoradiation, they will be     randomised to weekly carboplatin and paclitaxel chemotherapy for 6 weeks followed by     chemoradiation or to chemoradiation alone. The trial will recruit for 4 years with 5 years of     follow up period.   "
131321|NCT01566136|"     Hip fractures are a danger to an individual's mobility, independence and ability to live in     the community. When patients have a cognitive impairment (such as dementia or delirium) they     do not recover as well or go back to their homes as often as those patients who do not have a     cognitive impairment. Therefore, our team developed a rehabilitation model to care for     patients with hip fractures, and specifically for those patients with CI. The model of care     is called the Patient Centred Rehabilitation Model of Care (PCRM-CI). This 3 year study will     focus on comparing the new model with usual rehabilitation care. This study will also focus     on understanding the factors that could influence the use of the model on new rehabilitation     units. The investigators hypothesize that patients who have received the new model of care     will have better mobility outcomes over time. The investigators will collect data in 2     hospitals, 70 patients receiving the usual care and 70 patients receiving the care in the new     model. The team will invite 60 staff and their unit managers as well. This study will help     decision makers to use research findings to make better decisions about care of older     Canadians.   "
131322|NCT01566123|"     Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain     disappointing even after gross total resection, mainly because wide margins are not     achievable in the majority of patients. In contrast to extremity sarcoma, postoperative     radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose     and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some     centers to overcome these dose limitations and resulted in improved outcome, local failure     rates are still high even if considerable treatment related toxicity is accepted. As     postoperative administration of RT has some general disadvantages, neoadjuvant approaches     could offer benefits in terms of dose escalation, target coverage and reduction of toxicity,     especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT)     are considered.      Therefore the RETROWTS trials has been designed as a prospective, one armed, single center     phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy)     followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable RSTS.     The primary objective is the local control rate after five years. Secondary endpoints are     progression-free and overall survival, acute and late toxicity, surgical resectability and     patterns of failure. The aim of accrual is 37 patients in the per-protocol population.   "
131323|NCT01566110|"     Currently no consensus exists on the optimal way to manage asymptomatic patients with celiac     disease (CD) and Type 1 diabetes (T1D). The impact of dietary treatment as it pertains to     clinically relevant outcomes such as metabolic control, bone mineralization and wellbeing     will be evaluated in this study. A randomized controlled study longitudinally evaluating     HbA1c and glycemic excursions using continuous glucose monitoring will rigorously determine     the impact of a gluten-free diet (GFD) on blood glucose variability in patients with T1D.   "
131324|NCT01566097|"     Despite the establishment of various smoking cessation methods, including pharmacological     intervention, only a small proportion of smokers who visit doctors choose to receive such     assistance. Such under-utilization is especially apparent in some cultures, as in the case of     Korea, where a government survey showed that only 0.5% of current or formal smoker reported     they had been prescribed smoking cessation medication. Shame in asking for help for an     addictive disorder has been recognized as one of the most recognized cultural barrier in     Asian-American population. It is clear that culturally focused studies on smoking cessation     is warranted.      Patient decision aids are tools that help people become involved in decision making by     providing information about the options and outcomes and by clarifying personal values.     Patient decision aids have been developed to help patients decide whether to quit smoking or     not, or whether to use smoking medication or not. However, such previous studies have only     been focused on western populations.      The main purpose of this study is to develop a culturally appropriate decision aid for     smoking cessation for the Korean population, as well as evaluate its effect on their decision     to use smoking cessation medication. The investigators expect that culturally tailored     smoking cessation decision aids would increase knowledge about efficacy of smoking cessation,     make people have more positive attitudes toward smoking cessation medication, encourage     people to discuss about smoking cessation medication with their physicians. Ultimately the     investigators expect it would increase usage of smoking cessation medication and enhance the     quitting rate of smoking, which is a very important clinical issue.   "
131325|NCT01566084|"     The investigators hypothesize that reducing salt in the diet will improve the function of     blood vessels in middle aged and older adults with moderately elevated systolic blood     pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing     the amount of oxidative stress.   "
131326|NCT01566071|"     The main objectives of this study are:        -  To evaluate the driving capacities in a population of elderly subjects with early stage          Alzheimer Disease (AD) in a real-life situation.        -  Define a typology of the main errors made in this population.        -  Propose adaptive measures or technological aids that would make it possible for these          patients to maintain their ability to drive a car while limiting risk.   "
131327|NCT01566058|"     The main objective of this study is to compare the degree of maternal anxiety at Day 3     postpartum in mothers who did or did not have access to a video communication system (BB-Box     system) from the time of initial separation with their baby.   "
131328|NCT01566045|"     This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion     biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing     subjects with prostate cancer.   "
131329|NCT01566032|"     The amount of air leaking from a chest tube can be measured in two main ways:        1. electronic monitor connected to the chest tube        2. numerical (non-electronic) monitor connected to the chest tube      For people who have had lung surgery, it is important to understand the impact of measuring     air leaks accurately in both the short term and the long term. An electronic medical device     called Thopaz measures air leak electronically. Another medical device called Pleur-evac     measures air leak numerically. The purpose of this study is to understand the accuracy of the     method used by doctors and nurses to determine if a chest tube has an air leak. It is also     important to determine the size or severity of an air leak.   "
131710|NCT01561027|"     The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy     of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.   "
131330|NCT01566019|"     The primary objective of the study is to use high throughput molecular analysis (CGH Array     and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order     to improve the progression free survival compared to the previous treatment line.      The secondary objectives are to investigate clinical practical feasibility of such technics,     to potentially improve the overall survival of patients and to describe molecular portrait of     Phase 1 candidates.   "
131331|NCT01566006|"     Diabetes mellitus (DM) is a growing disease and it is a public health concern, and     projections of its future effect are alarming. About one third of those affected will develop     diabetic nephropathy at 20 years after diagnosis. Of these patients, 20% will develop     clinically end-stage renal disease ESRD, requiring renal replacement therapy (RRT). Patients     with type 2 diabetes account for most patients with end stage renal disease (ESRD) and RRT.      To the best of the investigators knowledge, the effects of MMF on diabetic nephropathy in     patients with DM type II were not studied so far. Therefore, the purpose of this pilot study     is to evaluate the effects of Mofetil Mycophenolate (MMF) on proteinuria and progression of     kidney disease of diabetic origin, in patients at high risk for progressive renal failure in     whom other treatment modalities are insufficient or had failed.   "
131332|NCT01565993|"     The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before     polypectomy in our usual clinical practice, through a prospective randomized study that     determines their effectiveness compared to conventional polypectomy, assessing the decrease     in immediate and delayed post-polypectomy bleeding   "
131333|NCT01565980|"     Managing psychological and physical symptoms to improve quality of life in patients with lung     cancer are a major public health concern. Mindfulness-based therapies are showing promise in     modifying psychological distress and improving quality of life in some cancer groups, but     little testing has included lung cancer samples. Mindfulness-based therapies integrate     meditation, breathing, and gentle yoga practices to promote an attitude of nonjudgmental     acceptance and awareness of bodily states. Such strategies may promote well being,     self-regulation, and symptom management. The study purpose was to test the acceptability,     feasibility, and symptom / health-related quality of life (HRQOL) outcomes of a home-based     mindfulness intervention for individuals with advanced lung cancer during non-curative     treatment (radiation and/or chemotherapy). Acceptability and feasibility were measured via     patient consent and retention rates, therapy expectancy, study adherence, attrition reasons,     and quality assurance indicators. Efficacy was determined via symptom and HRQOL (health     perceptions, physical and emotional function) outcomes. 40 patients undergoing treatment of     non-small cell lung cancer were randomized to receive either six weekly mindfulness sessions     (N=20) or an attention control condition (N=20). Outcome data was obtained at baseline (Time     1), post-intervention (Time 2, week 8), and four weeks after completion (Time 3, week 11). In     addition, both groups received weekly symptom assessment interviews. The hypothesis was that     the mindfulness group would report better symptom management and HRQOL (lower worry, dyspnea,     insomnia, depression; higher physical and social function; more positive health perceptions)     than the attention control group at the protocol end and that these differences will be     sustained at Time 3.   "
131334|NCT01565967|"     The purpose of this study is to show the success of the AutoLog System in removing lipids to     less than 10mg/dl in vivo. The Autolog registry has two objectives:        1. to determine the lipid removal capabilities of the Medtronic AutoLog System.        2. to obtain in vivo data on blood component removal and washing capabilities of the          Medtronic AutoLog System.   "
131335|NCT01565954|"     In Sickle cell disease children, sleep respiratory abnormalities are risk factors for     vaso-occlusive complications, as well as cerebral vasculopathy.      A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems     frequency and etiology, as well as their influence on sickle cell disease complications.   "
131336|NCT01565941|"     Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels,     is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown     to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult     critically ill surgical patients but has since come under intense scrutiny due to conflicting     results in recent adult trials. One pediatric RCT has been published to date that     demonstrated survival benefit but was complicated by an unacceptably high rate of severe     hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a     multi-center, randomized clinical treatment trial comparing two ranges of glucose control in     hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of     glucose control fall within the range of usual care for critically ill children managed in     pediatric intensive care units.      The purpose of the study is to determine the comparative effectiveness of tight glycemic     control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of     150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU)     length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or     respiratory failure. This will be accomplished using an explicit insulin titration algorithm     and continuous glucose monitoring to safely achieve these glucose targets. Both groups will     receive identical standardized intravenous glucose at an age-appropriate rate in order to     provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an     explicit algorithm combined with continuous glucose monitoring using a protocol that has been     safely implemented in 490 critically ill infants and children.   "
131337|NCT01565928|"     The purpose of this study is to determine the safety of MDV3100 given in combination with     Docetaxel in men with advanced prostate cancer.   "
131338|NCT01565915|"     The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.   "
131339|NCT01565902|"     This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate     and severe hepatic impairment compared to healthy control subjects.   "
131340|NCT01565889|"     This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early     viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the     safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its     metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the     Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated     interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.   "
131341|NCT01565876|"     Combat soldiers are required to perform under strenuous physical conditions; hence, their     physical fitness is a crucial factor in their survivability.      The Auxiliary Device- Minkal, is suggested (by its manufactures) to be able to reduce the     soldiers' physiological strain by lowering the absolute load being carried by the soldier. As     a result, it may improve the soldier's physiological abilities and performance through     enduring missions with heavy loads, and may lead to better protection on the soldier from     overuse injuries.   "
131342|NCT01565863|"     The purpose of this study is to test the effectiveness of the Progressive Goal Attainment     Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans     with disabilities.   "
131343|NCT01565850|"     This study is to evaluate the safety and efficacy     darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination     (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir     disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as     determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.   "
131344|NCT01565837|"     The purpose of this study is to evaluate if precisely-targeted radiation therapy, known as     stereotactic ablative radiotherapy (SART), given during treatment with the drug ipilimumab     (Yervoy) will improve survival for patients with melanoma that has spread to five or fewer     sites (oligometastatic).      Blood samples will be collected for research purposes. Planned studies include exploration of     certain gene mutations and serum markers as predictors of response to ipilimumab treatment.     Research lab studies will also evaluate if circulating tumor cells (CTC) can be accurately     detected and isolated from the blood using novel laboratory techniques and if they are a     prognostic/predictive marker for treatment response. Test results will not be given to     participants or their physicians. In some cases, CTC may be grown for long-term cell lines     for further research.   "
131345|NCT01565824|"     The aim is to investigate whether the implementation of a web-based support to women with     type 1 diabetes during pregnancy and early motherhood can improve well-being and self     management of diabetes. Type 1 diabetes is associated with increased medical risks and     increased psychosocial pressure in relation to childbearing. There is need for extended     support from both health care professionals and peers. Web-based interventions can improve     personal capacity and self-management in people with long- term illnesses but are not     evaluated in childbearing women with type 1 diabetes. A web site prototype for full-size     browsers and mobile devices has been developed through a participatory design by     multidisciplinary researchers, health care professionals, experienced mothers with type 1     diabetes and web designers. In a randomised control study the developed web site offering     information, communication with health care professionals, person-centred self-care diaries     and online social community of included women, is provided to the intervention group in early     pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden. A control     group will receive standard care (usual care). Total n = 160. Primary outcomes are Well-Being     Questionnaire and Diabetes Empowerment Scale. The intervention offers proactive solutions for     strengthening patients' decision making of diabetes in daily life during pregnancy and early     motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of     diabetes.   "
131346|NCT01565811|"     Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal     cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic     factors in oncologic surgery; however, the role of lymph node dissection remains unclear for     colorectal cancer liver metastasis.   "
131347|NCT01565798|"     CONTEXT: Healthcare-acquired infections (HAI) cause substantial patient morbidity and     mortality. Commonly touched items in the patient care environment harbor microorganisms that     may contribute to HAI risk. Thus, reduction in the surface bioburden may be an effective     strategy to reduce HAI. Inherent biocidal capabilities of copper surfaces offer a theoretical     advantage to conventional cleaning, as disinfection is continuous rather than episodic.      OBJECTIVE: Determine whether placement of copper-alloy surfaced objects in an intensive care     unit (ICU) reduce risk of HAI.      DESIGN: An intention to treat study where patients are sequentially placed into rooms with or     without copper-alloy surfaced objects.      SETTING: The ICUs of three hospitals, a tertiary academic hospital, an academic cancer     center, and a Veteran's Administration Medical Center.      PATIENTS: Any patient 18 years of age or older who required admission to an ICU at a study     hospital is eligible for placement into a study room if available.      INTERVENTION: Placement of copper-alloy surfaced objects in an ICU room. MAIN OUTCOME     MEASURE: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus     aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.   "
131348|NCT01565785|"     The purpose of this study is to pilot test the 'Family Self- Management Discharge Preparation     Intervention [FSM-DPI]' that focuses on content and delivery methods to support an effective     family transition to home self-management after a child's hospitalization.   "
131349|NCT01565772|"     This research study is looking at an alternative way of delivering radiation therapy with     protons. Protons are tiny particles with a positive charge that can be controlled to travel a     certain distance and stop inside the body. In theory, this allows better control of where the     radiation dose is delivered as compared to photons. Information from other research studies     suggests that proton radiation may help to reduce unwanted side effects from radiation and     allow an increase in radiation dose that increase the odds of tumor killing.      The purpose of this study is to determine the safest dose of proton radiation therapy to give     in combination with standard chemotherapy in participants with Non-Small Cell Lung Cancer     (NSCLC).   "
131384|NCT01563406|"     Central venous catheter infections are common preventable adverse events among hospital     patients. Microbes may enter catheter hubs, also known as needleless connectors, and result     in downstream contamination. This study aims to compare alcohol disinfection of catheter hubs     to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a     superior disinfectant at the site of central venous catheter insertion. Scrub duration of     central venous catheter hubs will also be evaluated.   "
131611|NCT01562327|"     This multi-center, observational study will evaluate the clinical practice patterns, efficacy     and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe     rheumatoid arthritis. Data will be collected from each eligible participant initiated on     RoActemra/Actemra treatment by their treating physician according to local label for 6 months     from start of treatment.   "
131350|NCT01565759|"     Psychiatric disorders often result from dysregulation in cellular and molecular mechanisms at     the level of the brain. Unable to directly study brain tissues in patients affected by     psychiatric conditions, researchers have created alternative experimental models that use     different and easy to collect tissues. The underlying assumption is that by studying these     proxy tissues, it is possible to obtain information on biological mechanisms that is a good     approximation of what would be detected in the brain. One of the most established     experimental models are lymphoblastoid cell lines derived from B-lymphocytes. Lymphocytes are     present in the peripheral blood and can be easily collected and stored virtually forever     after undergoing a special laboratory procedure that immortalize them. These cell lines have     proved to be very useful in genetic and pharmacogenetic research and, using these, the     investigators want to investigate the cellular effects of a mood stabilizing drug called     lithium on this specific procedure that makes them virtually immortal. Two main reasons lead     us to study this drug: 1) it is the most effective treatment in bipolar disorder, where     approximately 30% of patients achieve complete illness remission with prevention of episode     recurrence; 2) it has well established regulatory effects on the expression of specific     target genes and proteins. The investigators can take advantage of these well-established     properties of lithium in regulating the expression of genes, proteins, and enzymes in a     stable manner. Conversely, these biological measures could be used as markers for the effects     of lithium on the gene expression.      The purpose of this study is to learn more about the changes in the activity of genes in     cells sampled from healthy individuals treated with lithium. By studying these cellular     changes, the investigators hope to understand if lymphoblastoid cell lines are valid tools in     psychiatric genetics research. Specifically, the investigators want to see how specially     treated lymphoblastoid cell lines are influenced by external conditions and specifically     lithium treatment at the moment of sampling. To do so, the investigators will measure the     gene expression (i.e. how much gene is in the cell) of lymphoblastoid cell lines and compare     the levels between those sampled before and after one month of lithium treatment.   "
131351|NCT01565746|"     This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety,     biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in     Japanese patients with castration-resistant prostate cancer and bone metastases.   "
131352|NCT01565733|"     This study is conducted in Europe. The aim of this study is to evaluate the safety and     efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2     diabetes with the aim of intensifying their treatment.   "
131353|NCT01565720|"     This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in     healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups     and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an     active control on the last dosing day to healthy subjects in one of the four groups. All     treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the     study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on     three study days. ECGs, vital signs, blood draws will be obtained throughout the study for     safety and to assess the amount of study drug in body.   "
131354|NCT01565707|"     Solifenacin succinate as a tablet formulation is already on the market for the treatment of     symptoms of overactive bladder in adults. For the use in children and adolescent patients a     new formulation of solifenacin has been developed.      This study investigated the effect and safety of solifenacin succinate liquid suspension     compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the     double blind period was a single-blind placebo run-in period in combination with behavioral     urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder     (OAB) information, awareness, instruction, life-style advice and documentation of voiding     habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also     investigated how well solifenacin succinate suspension is taken-up by the body and how long     it stays in the body during this time.   "
131355|NCT01565694|"     The purpose of this study is to investigate a medicine for the treatment of symptoms and     complications of neurogenic detrusor overactivity (NDO) in children and adolescents. NDO     often occurs in patients with spina bifida or other spinal cord damage where the bladder     muscle contracts more than normal during filling. These patients often have an inability to     void, so that catheterization is required to empty the bladder.      The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets     are given to adults for the treatment of overactive bladder. A new liquid suspension has been     developed to treat children and adolescents in this and other studies.      The efficacy and safety of the solifenacin suspension will be investigated. The take-up and     length of time that the solifenacin suspension stays in the body will also be investigated     during this study.      The study will last for approximately 12 months, where completing patients will receive 52     weeks of continuous treatment.      Effectiveness will be measured by urodynamics (the filling and emptying of the bladder) and     urine volumes measured during catheterization together with the diary responses relating to     the number of incontinence episodes or incontinence free days.      Safety assessments include analysis of the blood and urine, review of the ECG, ultrasound of     the kidney, simple memory and understanding tests (cognitive function) and the ability to see     near and far objects (visual accommodation).   "
131356|NCT01565681|"     The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and     pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in     healthy subjects.   "
131357|NCT01565668|"     This study will evaluate two doses of Quizartinib in patients with relapsed or refractory     acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication (     FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment     arms. Both treatment arms will receive Quizartinib but at different doses. The study     treatment is taken orally in 28 day cycles until either disease progression occurs or an     unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease,     blood will be drawn to measure drug levels and biomarkers. Patients will be followed for     survival at three month intervals after the end of treatment.   "
131358|NCT01565655|"     The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to     severe rheumatoid arthritis (RA) subjects   "
131359|NCT01565642|"     This cluster randomized controlled trial is to examine whether decision support for goals of     care can improve quality of communication and decision-making and improve the quality of     palliative care for nursing home residents with advanced dementia.   "
131360|NCT01565629|"     This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)     program for children with anxiety and autism spectrum disorders.   "
131432|NCT01564862|"     The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on     cognitive dysfunction in patients with major depressive disorder.   "
131624|NCT01562158|"     This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the     efficacy of placebo and activated recombinant human factor VII in patients having undergone     allogeneic or autologous stem cell transplantation.   "
131361|NCT01565616|"     This is a Phase II, single arm, multi-center trial. It is designed to estimate the efficacy     and toxicity of hematopoietic stem cell transplantation (HSCT) in patients with sickle cell     disease (SCD) who have high risk features.      The primary goal of this multi-center Phase II study is to determine the safety and     feasibility of a conditioning regimen consisting of busulfan (Bu)/ fludarabine (Flu)/     anti-thymocyte globulin (ATG) in adult patients with severe SCD. A two-component design will     be used for this study. The first component will be restricted to patients who have an     HLA-identical sibling donor. Five patients will be transplanted during the first component of     the study. If no more than 2 of the first 5 patients experience unacceptable toxicity,     including death, within the first six months after transplantation, then the safety of the     regimen will be considered promising in adult SCD patients.      The second component will include patients who have a related or an unrelated human leukocyte     antigen (HLA) matched donor. Up to 15 additional patients will be transplanted in this     component of the study which will evaluate the safety and feasibility of unrelated donor     hematopoietic cell transplantation (HCT) in adults with SCD. Data related to study endpoints     for 1 year after transplantation will be collected; however, participating centers will be     encouraged to conduct long-term follow-up evaluations of patients according to standard     institutional guidelines. The purpose of this pilot safety trial is to see if this approach     is feasible and meets accrual goals lending support to the development of a subsequent full     scale investigation of HCT and comparing outcomes in a transplantation cohort to a control     cohort of adults eligible for, but unwilling or unable to receive HCT treated by supportive     therapy with a primary endpoint of five years survival for this full scale comparative trial.   "
131362|NCT01565603|"     Mechanisms underlying high-altitude intolerance as well as exercise performance limitation in     hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances on     one hand and cerebral perturbations on teh other hand may be key mechanisms. The     investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7 days     in order to better describe sleep and cerebral responses. The investigators hypothesized that     sleep and cerebral disturbances play a critical role for the developement of acute mountain     sickness and for exercise performance limitation during acute high-altitude exposure.   "
131363|NCT01565590|"     The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage     on dexmedetomidine compared to propofol to assess if one group has decreased inflammation.     The investigators hypothesis is that the group assigned to receive dexmedetomidine will have     a more profound decrease in markers of inflammation over time.   "
131364|NCT01565577|"     This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in     children aged 4-8 years.   "
131365|NCT01565564|"     Research question (s)/hypothesis:        1. . The effectiveness of the shared care management of gestational diabetes mellitus;        2. . The cost-effectiveness of the shared care management;        3. . Its sustainability   "
131366|NCT01565551|"     The global aim of this proposal is to test and refine Common Data Elements (CDEs),     neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain     Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center     prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH),     University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge     (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The     investigators will create and expand existing data repositories for patient demographics,     neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing     researchers and clinicians with the infrastructure to establish multidisciplinary,     multicenter research networks and improve clinical research in the TBI field.   "
131367|NCT01565538|"     Both pemetrexed and erlotinib are second-line treatment options for patients with advanced     non-small cell lung cancer. It is controversial that whether it is necessary to detect     epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after     the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive     marker remains controversial. Therefore, we investigate the efficacy of erlotinib and     pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR     FISH-positive advanced lung adenocarcinoma.   "
131368|NCT01565525|"     The purpose of this pilot project is to test anticipatory guidance, which is information     given to families during a well child visit to prevent obesity during childhood. The     objectives were to compare two styles of anticipatory guidance during the first year of life,     maternal focused and infant focused, versus usual care and determine which style, if any,     showed the most ideal infant feeding behaviors at age 1 year and to see if there were any     differences in infant weight for height at one year of age. The investigators hypothesized     that mothers who received the maternal focused anticipatory guidance (which gave information     on eating family meals, not having tv on during meals, and maternal nutrition) would actually     have the best infant feeding behaviors and weight for height of infants at one year.   "
131369|NCT01565512|"     The indwelling urethral foley is a major source of discomfort following radical     prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with     bupivacaine may decrease immediate post-operative foley discomfort.   "
131370|NCT01565499|"     Study GEICAM 2011-02 is a multicenter, open label, non-randomized phase 2 trial to evaluate     the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive HER2     negative patients amenable to receive neoadjuvant chemotherapy.      The primary objetive of the trial is to determine the percentage of patients with poor     response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual     cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with     stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.      The primary endpoint of the study is to determine the residual cancer burden grade III     (RCB-III) after surgery.      The total number of patients to be included in this study is 78 patients.      The duration of the study, from first patient visit to last patient visit will be     approximately 90 months (Including follow-ups)   "
131371|NCT01565486|"     The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device     (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure     Precise™, Covidien) in surgery for thyroid cancer.      Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES),     Recurrence-free survival (RFS), Overall survival (OS)   "
131457|NCT01563302|"     This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of     patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will     be enrolled into the dose-expansion cohort.   "
131458|NCT01563289|"     The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients     with ankle injuries.   "
131625|NCT01562145|"     The aim of the study was to investigate the levels of matrixmetalloproteinases and their     inhibitors in blood samples from patients with rotator cuff tears and compare with blood     samples from healthy matched controls.   "
131372|NCT01565473|"     This research plan is focused on neurochemical positron emission tomography (PET) studies of     Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and     considerable progress has been made in understanding and treating the typical movement     abnormalities of resting tremor, bradykinesia and rigidity. These cardinal PD features are     all initially responsive to dopamine replacement therapy, and have been investigated     intensively with respect to their relationships to degeneration of the nigrostriatal dopamine     projection. More recently, increased attention has focused on the non-motor clinical     aspects of PD, including cognitive, mood, chronobiological and peripheral autonomic defects.     These clinical features are less reliably affected by dopaminergic therapy, and are likely to     be associated with other, non-dopaminergic neural degenerations. Indeed, detailed postmortem     assessments of PD brain reveal substantial neuronal losses in a variety of chemically-defined     neurons, including brainstem serotonin and norepinephrine neurons and basal forebrain     cholinergic neurons. Projects in the proposal will focus on dementia, depression, sleep-apnea     and dysautonomia in PD patients, employing PET measures of presynaptic dopaminergic,     serotoninergic and cholinergic CNS neurons and of peripheral sympathetic neurons. Results of     the investigations may identify associations of non-motor PD signs and symptoms with the     non-dopaminergic neuronal losses. These findings will establish additional therapeutic     targets for symptomatic, but also for potential neuroprotective PD therapies. In addition, a     majority of patients will be characterized with all 3 CNS PET measures. The availability of     multiple markers of distinct neuronal populations involved in PD neurodegeneration will     permit exploratory analyses to assess whether the degenerations are correlated (possibly     manifestations of a common pathophysiology) or apparently independent (possibly a     manifestation of multiple PD subtypes or pathophysiologies). Ultimately, better understanding     of these non-motor features will be essential to developing future treatments that address     the entire PD patient.   "
131373|NCT01565460|"     The purpose of this study is to create a long-term storage of bile and brushings of     pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future     research.      Recently, a lot of research has been done to test for certain markers in the bile and     brushings to detect cancer in a stricture. The samples will be used to measure biomarkers     (proteins) in biliary diseases.   "
131374|NCT01565447|"     This purpose of this study it to characterize the walking patterns of children diagnosed with     Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in the     treatment protocol and after completion of treatment. Their walking patterns will be compared     to children without ALL or LL to see if their walking patterns are different at specific     times in their treatment program or up to 10 years after completion of their treatment. The     investigators will gather data by observing how the child walks, runs, hops on one foot and     climbs stairs and by recording walking patterns on a pressure sensitive mat. The     investigators will compare this data to children without ALL and LL.   "
131375|NCT01563523|"     This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this     trial is to evaluate the efficacy of activated recombinant human factor VII given in     conjunction with standard therapy in the treatment of massive bleeding in subjects with     severe blunt and/or penetrating trauma injury.   "
131376|NCT01563510|"     The purpose of this research is to investigate the key technology and the related issues of     minimal invasive treatment for hepatolithiasis and to build new methods of minimal invasive     operation for hepatolithiasis. The validity, feasibility and limitations of the laparoscopic     operation were assessed objectively through our clinical prospective study. The technique     points, indications and contraindications were summarized to evaluate the status and role of     minimal invasive laparoscopic operation in the treatment of hepatolithiasis.   "
131377|NCT01563497|"     The primary purpose of this study is to estimate the relative bioavailability and food effect     of a PF-05089771 tablet.   "
131378|NCT01563484|"     Primary Hepatocellular Carcinoma (PHC) is one of the most common malignant tumors in the     world. In men is the fifth most frequently diagnosed cancer worldwide but the second most     frequent cause of cancer death. In women, it is the seventh most commonly diagnosed cancer     and the sixth leading cause of cancer death. An estimated 748,300 new liver cancer cases and     695,900 cancer deaths occurred worldwide in 2008. Half of these cases and deaths were     estimated to occur in China. Surgical resection and liver transplantation can be curative     treatment options, but less than 20% of PHC patients are candidates for surgery. The     prognosis of patients with unresectable PHC is poor; if left untreated, the median survival     is less than 6 months. Since transarterial chemoembolization (TACE) was introduced as a     palliative treatment in patients with unresectable HCC, it has become one of the most common     forms of interventional therapy. However, the possibility of treatment-related complication     may offset the survival benefit, especially by the worsening of liver functions.TACE     increases several parameters of hepatic cytolysis and decreases the metabolic activity of the     liver. Such a deterioration of liver function due to ischemia following TACE may result in     liver failure, or even death. TACE also may have an adverse effect on the kidney.     Radiographic contrast medium is used to obtain the hepatogram before TACE. It has been shown     that the use of contrast medium increases the risk of renal failure, especially the     low-osmolar contrast media. The aim of this trials was to compare the change of liver and     renal function after TACE for HCC of iso-osmolar contrast media with that of low-osmolar     contrast media.   "
131379|NCT01563471|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacokinetics of three different single doses activated recombinant human factor VII in     Caucasian and Japanese healthy subjects.   "
131380|NCT01563458|"     This trial is conducted in Europe, North America and Oceania. The aim of this trial is to     evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects     undergoing orthotopic liver transplantation surgery.   "
131381|NCT01563445|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     evaluate the safety and preliminary efficacy of activated recombinant human factor VII     (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).   "
131382|NCT01563432|"     This study was designed to compare and evaluate the pharmacokinetic characteristics of     febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in     healthy adults; and to evaluate safety and tolerance following a single-dose administration.   "
131383|NCT01563419|"     Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit     inadequate glycemic control in spite of combination of oral antidiabetic drugs and eventually     need insulin therapy. Patients who need insulin therapy are older and have poor visual     acuity, which predispose to inaccurate dosing and consequent hyper or hypoglycemia.In this     study, the investigators examined the clinical usefulness of a magnifier for elderly diabetic     patients who had used insulin pens.   "
131761|NCT01560364|"     This is a prospective observational clinical multicentric study in ICU with acute renal     failure requiring renal replacement therapy.   "
131385|NCT01563393|"     Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic     malnutrition caused by chronic diseases. According to various studies, about 10-20% of those     admitted to hospitals in different countries suffer from malnutrition or are at risk of     malnutrition.      Several pediatric nutritional screening tools were recently published. However, there is no     conventional pediatric nutritional screening tool and the effect of the recently published     tools on further nutritional risk and the behavior of the attending staff are unclear.      Study objectives: to test the validity and reliability of the STAMP nutritional screening     tool (Screening Tool for the Assessment of Malnutrition in Pediatrics) among children     hospitalized in a pediatric medical center and to examine the effect of the STAMP tool use on     the attitude of the medical staff to the patient nutritional status.      An additional objective is to compare the skill of a nurse versus a dietician in performing     the evaluation according to STAMP.      Methods: for the validation, 50 children between 1 and 17 years of age from internal medicine     and surgical departments will undergo a complete evaluation by an investigating dietician and     assessment by the STAMP tool in order to determine the extent of the nutritional risk on a     numerical scale. All the children will undergo STAMP evaluation by a nurse and another     investigating dietician as well.      In order to examine the effect of the tool on the medical staff awareness, 300 files of     hospitalized children will be tested: 150 files at the beginning of the study and prior to     using the tool and 150 after 6 months at the same ages and in the same departments.      The effect of using the STAMP questionnaire will be examined according to the results of data     collection from the beginning of the study and after 6 months. Questionnaire use, recording     of appropriate diagnoses, collection of blood tests demonstrating the nutritional status,     weight, height and waist circumference measurements will be obtained from the patients'     medical files.   "
131386|NCT01563380|"     This study was designed to evaluate the efficacy of leucocyte free autologous platelet rich     plasma on blood loss, pain, wound healing and functional outcome after total knee     arthroplasty. The investigators hypothesized that application of platelet rich plasma would     help in reducing blood loss, postoperative pain and expedite wound healing and better     short-term functional outcome following total knee arthroplasty.   "
131387|NCT01563367|"     The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®)     is superior compared to placebo with respect to increasing the haemoglobin level in     non-anaemic patients undergoing cardiac surgery   "
131388|NCT01565434|"     Main objective: investigate whether a functional polymorphism of CR1 (length, number of     binding sites in C4b C3b, erythrocyte density, rate of soluble CR1 ...) so determined genetic     or acquired, is a susceptibility factor for the disease Alzheimer's.   "
131389|NCT01565421|"     This study will assess the effect of IT-101 on delaying cancer progression in patients with     platinum sensitive ovarian cancer.   "
131390|NCT01565408|"     This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the     safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid     arthritis (RA).   "
131391|NCT01565395|"     The purpose of this study is to evaluate the safety and efficacy of Incobotulinum Toxin A     (Xeomin®) injections into the parotid and submandibular glands in patients with Parkinson's     Disease/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) with troublesome sialorrhea.   "
131392|NCT01565382|"     Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained     using updated reading methodology. The scans in this study came from subjects who had     Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).   "
131393|NCT01565369|"     The purpose of this study is re-read of brain amyloid positron emission tomography (PET)     scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated     reading methodology. The scans in this study came from subjects who had an autopsy to reveal     the subject's true amyloid status.   "
131394|NCT01565356|"     This study will re-read 10-minute positron emission tomography (PET) scans acquired in     previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the     results.   "
131395|NCT01565343|"     This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy     volunteers provide the same results. The study will also test two different AV-45 injection     methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).   "
131396|NCT01565330|"     This study will test two different doses of florbetapir F 18 to determine which dose is best     to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron     emission tomography (PET) scanner.   "
131397|NCT01565317|"     The purpose of this study is to find out the impact of improving diabetes control through     weight reduction and lifestyle changes on a common diabetes complication called peripheral     neuropathy.   "
131398|NCT01565304|"     The purpose of this study is to evaluate the effectiveness of the POWER Through Choices (PTC)     curriculum in increasing contraceptive use and delaying sexual initiation among youth living     in group foster care homes.   "
131399|NCT01565291|"     A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of     healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron     emission tomography (PET) scanner.   "
131400|NCT01565278|"     Patients who are not able to eat normally for a longer time require parenteral nutrition,     i.e. they receive liquids and nutrients directly into their veins. This can have many     long-term side effects, including liver problems. This study will examine whether a specific     lipid emulsion containing fish oil can improve liver disease in patients on parenteral     nutrition. The investigators will compare changes in bilirubin and liver enzymes after 3     months in 10 patients receiving standard lipid emulsion to 10 patients receiving standard     lipids + a fish-oil containing emulsion. The investigators will also assess liver histology,     the kind of fat, oxidative stress and gene expression in the liver at the beginning and after     6 months of fish-oil. The investigators also want to compare the baseline values from all 20     patients to 20 healthy controls. This will help to explain how fish oil may improve liver     disease in patients on parenteral nutrition.   "
131469|NCT01564498|"     The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds     including anthocyanins will have higher antioxidant and other biological activities, than     more lightly coloured versions of these foods. Diets of human subjects will be modified to     allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be     randomized to consume either orange or purple carrots, or white or purple potatoes. They will     consume these diets for 12 weeks and bioavailability of polyphenolics will be examined as     well as anthropometry and blood biochemistry for changes in risk factors associated with     cardiovascular disease.   "
131470|NCT01564485|"     This study looked at the role of cardiac CT in improving risk factor control in those with     diabetes.   "
131471|NCT01564472|"     The objective of this study is to validate the ability of the Sleepware G3 polysomnography     software platform to correctly identify and score sleep related events.   "
131472|NCT01564459|"     The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the     treatment of painful diabetic neuropathy (PDN) in adults.   "
131401|NCT01565265|"     The purpose of this study is to assess the non-inferiority of a multidose GnRH antagonist     (cetrorelix) regimen to a GnRH agonist (triptorelin) long protocol in young infertile women     undergoing ovarian stimulation with Pergoveris 150 I.U./75 I.U. (r-hFSH/ r-hLH) for ICSI     treatment because of male infertility.      To assess the efficacy of ovarian stimulation using either a GnRH antagonist (cetrorelix) or     a GnRH agonist (triptorelin) long protocol in infertile women with good prognosis and to     determine the safety of ovarian stimulation.      Subsample analysis: in 10 patients of each of both arms, serum samples will be collected     daily during the stimulation period and be stored frozen at -70 °C. The following hormone     concentrations will be measured later in single assay batches: LH, FSH, oestradiol,     progesterone, androstenedione, testosterone, inhibin A, inhibin B, AMH.      Multinational, multicentre, open label, randomized, 2-arm parallel-group phase IV study.     Eligible patients will be randomly allocated to one of the two groups: the agonist group will     receive Decapeptyl® 0.1 mg (triptorelin) starting in the mid-luteal phase of the natural     cycle until downregulation until the day of ovulation induction. The antagonist group will     receive cetrorelix 0.25 mg from stimulation day 6 to ovulation induction. In both groups,     Pergoveris® 150 I.U./75 I.U. (r-hFSH/r-hLH) will be used for ovarian stimulation from cycle     day 2 to ovulation induction.   "
131402|NCT01565252|"     Study Rationale:      As epidemiological research has shown negative effects of high egg consumption on increased     all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate     their effects on diseases risks, it is important to test the effect of eggs with different     composition on markers associated with dyslipidemia, dysglycemia and inflammation.      The aim of this study is to assess the effect of n-3PUFA (Omega 3) fortified egg compared to     omega-6 Israeli regular egg on metabolic, inflammation and other physiologic parameters.   "
131403|NCT01565239|"     Experiments suggest that during treatment with vitamin K antagonists (VKA) the activity of     coagulation factors (F) II and X better reflect anticoagulation than does FVII. Based on this     a new prothrombin time based monitoring test (Fiix-PT) has been invented which is only     sensitive to FII and FX. The Fiix-PT can be converted to INR (Fiix-INR).      The investigators hypothesize that the Fiix-PT may reflect anticoagulation and the     antithrombotic effect of VKA as accurately or better than the current PT based tests do (INR     based on PT or P&P). The protocol describes a prospective randomized double-blind trial that     will be conducted at the Landspitali Anticoagulation Management Center (AMC).      The objective of the protocol is to evaluate the efficacy and safety of Fiix-INR as a     monitoring test compared to the current PT based assays (INR) used to monitor patients     treated with VKA to prevent thromboembolism. The investigators will randomize 1200 clients of     the AMC into two identically sized monitoring groups, Fiix-INR (test group) and INR (control     group).      The clinical endpoints to be studied include efficacy (arterial and venous thromboembolic     event rate) and safety (bleeding events). Additionally, surrogate convenience endpoints will     be studied such as test frequency and time within target range.   "
131404|NCT01565226|"     -  This will be an observational study. Respiratory data will be recorded using          Capnostream20p. There will be no use in the recorded data for the medical care of the          patients. Other clinical data will be captured in the CRF. Similar study is currently          conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited          without any adverse events.        -  During the study the medical team will capture in the CRF the following: Blood gas and          distal capnography values at time of sampling, ventilator settings at time of sampling.        -  Changes made in the ventilation parameters, blood gas time and results, concomitant          treatment (e.g. suction) and concomitant medication (respiratory related e.g.          surfactant), vital signs all these will be retrieved from the patient's medical charts.   "
131405|NCT01565213|"     The purpose of this study is to compare the effects of CBT and MMI on the quality of life and     relief of psychological symptoms of patients with common mental disorders or problems     attending primary health care centre.   "
131406|NCT01565200|"     T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the     coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine     derivate) has shown an encouraging antitumor activity evaluated by Recist criteria (35%     objective response rate, 44% stable disease, 18% progressive disease) in patients with     advanced HER2 positive Breast Cancer pretreated with several cytotoxic drugs, trastuzumab and     lapatinib.      Rationale I :For TDM1 to be active, the presence of an intact HER2 receptor is key since     the internalization of the cytotoxic moiety depends on the binding of trastuzumab to the     external domain of HER2.      The zirconium 89 labelled trastuzumab PET/CT (or HER2 immunoPET/CT) is a non invasive test     which shows promise in measuring HER2 expression (extracellular domain) for the entire     disease burden and which could identify non responding patients prior to TDM1 administration.      Rationale II: As for many such agents, it is desirable to identify early on (here with the     use of FDG-PET/CT) which patients are unlikely to benefit from the therapy   "
131407|NCT01565187|"     A prospective multicenter study utilizing standardized instruments for the psychological     assessment of hand transplant candidates pre and post-transplant as well as those candidates     excluded for transplantation.   "
131408|NCT01565174|"     There is growing evidence of high rates of substance use disorders among individuals with     psychotic disorders especially in young people with predisposition for psychosis. There is     some genetic evidence that carriers of the valine158 allele of the     catechol-O-methyltransferase (COMT) gene had increased risk to exhibit psychotic symptoms and     to develop schizophrenia if they used cannabis by the age of 18. It was also shown that     carriers of the COMT val/val genotype were most sensitive to THC-induced psychotic     experiences but this was conditional on pre-existing susceptibility to psychosis. The     investigators propose to use brain-imaging and molecular genetics to investigate whether     genetic factors may contribute to the THC-induced dopamine release and possibly to cannabis-     induced psychosis.   "
131473|NCT01564446|"     Background and Significance: Adverse drug events (ADE) are the most common of all healthcare     associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE     and avoidable healthcare utilization affecting up to 20% of patients. Insufficient monitoring     has been identified as a particularly common cause of preventable and ameliorable ADE. The     Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has called for a     process to accurately and completely reconcile medications across the continuum of care.     Inpatient computerized medication reconciliation tools have shown great potential, but little     is known about successful medication reconciliation strategies immediately post-discharge.     One promising solution to outpatient medication reconciliation is the use of secure     electronic communication (SEC) between patients, accessing their personal health record via a     web portal, and providers within an electronic health record. Surveys have consistently found     that patients want to communicate with their primary care providers via SEC, and SEC is     rapidly becoming a standard feature in electronic health records. A SEC-based approach to     outpatient medication reconciliation following hospital discharge has the potential to     improve patient safety, but important questions must be addressed, including: What     information needs to be included in the SEC? What elements of the SEC are essential to its     design? How can SEC be best incorporated into the workflow of the primary care office     practice? Will patients and physicians find this approach acceptable? To address these     questions, we propose a one-year pilot study at VA Boston with the following specific aims:      Aim 1: To evaluate the primary care environment's receptivity to secure electronic     communication (SEC) for medication reconciliation and design a prototype SEC. We will use     qualitative methods to characterize the primary care clinic environment - the physical space     and facilities, the workflow, the resources, as well as the knowledge, attitudes and skills     of staff and, most importantly, the patients. Specific approaches will include in-depth     interviews, direct ethnographic observations, and visualization methods Aim 2. To develop a     prototype SEC for medication reconciliation through a participatory design process, involving     primary care clinicians, staff and patients working collaboratively with the research team,     and to test the usability and acceptability of the prototype SEC among a sample of patients     and primary care clinicians.      Research and Development Plan: With extensive experience in designing and evaluating health     care informatics innovations, we have assembled a multi-disciplinary team with expertise from     primary care internal medicine, clinical informatics, health services research, qualitative     research, clinical pharmacy, nursing and industrial engineering. This team will carry out a     formative evaluation and develop a prototype of a secure electronic message to facilitate     medication reconciliation following hospital discharge. The proposed CIMIT project will     leverage the resources and expertise of the e-Health QUERI (a national VA program for     innovation and evaluation of the VA's e-Health programs) at VA Boston and other participating     VA facilities nationwide. The figure below shows a very rough conceptualization of the SEC     that will guide the qualitative research and participatory design of the prototype. This     project will lay the foundation for a future rigorous evaluation of this approach to     medication reconciliation and improving patient safety.   "
131486|NCT01564277|"     This randomized phase II trial studies how well giving rasburicase together with allopurinol     works in treating patients with hematologic malignancies. Rasburicase may reduce the level of     uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more     effective in treating hematologic malignancies when given together with or without     allopurinol.   "
131409|NCT01565161|"     While childhood obesity rates may have plateaued in some US population subgroups, such as     whites and those of higher socioeconomic status, overall rates of obesity remain high and     racial/ethnic and socioeconomic disparities appear to be widening. Among the most promising     approaches for childhood obesity prevention and management are interventions that begin early     in life and that support change at the individual and community levels.      The goal of this project is to develop and test an intervention delivered to racial/ethnic     minority and low income parents of 2-5 year old children in their homes, designed to promote     adoption of household routines and parenting strategies that are preventive of obesity. To     achieve this goal, the investigators will work with community health centers in Boston,     Cambridge, and Somerville to recruit families to participate in an individual-level     randomized controlled trial. The investigators partner community health centers include the     Roxbury Comprehensive Community Health Center, Dimock Community Health Centers, and the     Cambridge Health Alliance (CHA).      Participants will be randomized to receive either 1) mailed educational materials for the     duration of the 6-month program (control), or 2) home-based health coaching visits and phone     calls with a health educator, text messages, and educational materials promoting the adoption     of household routines and target behaviors (intervention).      The investigators goal is to evaluate the feasibility and effectiveness of the investigators     designed intervention (as compared to the control condition) using baseline and     post-intervention data. In order to do so, the investigators will assess change from baseline     to post-intervention in the investigators key behavioral outcomes of interest, including     adoption of three household routines:        1. Regularly eating meals together as a family        2. Obtaining adequate sleep        3. Limiting screen-viewing time   "
131410|NCT01565148|"     -  To assess the safety of repeated iCo-007 intravitreal injections in treatment of          subjects with diabetic macular edema as monotherapy and in combination with ranibizumab          or laser photocoagulation        -  To assess the change in visual acuity and retinal thickness on optical coherence          tomography (OCT) from baseline to month 8 and month 12   "
131411|NCT01565135|"     The purpose of this study is to determine if a multimodal immunization program carried out in     obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn     patients' immunization rates, specifically for Tdap, HPV, and influenza vaccines, than the     usual care provided to patients in ob/gyn practices.   "
131412|NCT01565122|"     This multi-center, observational study will evaluate the clinical practice patterns, efficacy     and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data     will be collected from each eligible patient initiated on RoActemra/Actemra treatment by     their treating physician according to approved label for up to 12 months from start of     treatment.   "
131413|NCT01565109|"     It is estimated to 7300 the number of new cases of gastric cancer each year in France.      According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU)     administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma     of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant     chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a     median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of     chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with     chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly     prolonged with a hazard ratio of 0.66.      The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the     schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple     combination as a reference treatment in metastatic gastric cancer in patients under 65 years.      Preoperative radiochemotherapy is expected to increase the rate of curative resections,     reduce gastrointestinal and hematologic toxicity.      Two studies evaluating the feasibility of preoperative RTCT in operable gastric     adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the     combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.      The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with     Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous     5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV     non-metastatic administered before surgery.   "
131414|NCT01565096|"     The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to     glimepiride on beta cell function and the cardiovascular risk profile in patients previously     treated with Metformin monotherapy.   "
131415|NCT01565083|"     This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy     of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line     participants with metastatic or locally advanced HER2-positive breast cancer. Participants     will receive pertuzumab and trastuzumab administered sequentially as separate intravenous     (IV) infusions (followed by vinorelbine) and conventional sequential administration of     pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.   "
131416|NCT01565070|"     Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in     the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is     produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient     Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ®     treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate     knee osteoarthritis, which would decrease the immobility and isolation in older adults.   "
131417|NCT01565057|"     This comparative study is designed to compare the gastric layering and rates of emptying and     by inference rates of digestion of two food emulsions. Two types of dairy based foods will be     used, one which will sediment in the stomach and one that will not. On each of two study     days, a total of 9 post drink MRI scans will be taken to assess gastric layering and     emptying. Cannulation will allow blood samples to be taken periodically for subsequent     analysis for the presence of specific digestion related hormones. A total volume of 36 ml of     blood will be removed and volunteers will also be asked to complete a questionnaire at     predetermined times to assess feelings of satiation.   "
131418|NCT01565044|"     Many patients retain upper-limb motor impairment following stroke. Most conventional     rehabilitation techniques are aimed to improve motor intentional movement by repeated     exercises. These techniques require attentional load and are responsible for significant     fatigue that probably represents a limiting factor. Alternatively, the automatic control of     action is now well documented. A rehabilitation method based on this principle could allow     recovery of more natural movements.      Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a     rehabilitation technique based on intentional movements.   "
131487|NCT01564264|"     The purpose of this study is to determine if there is a difference between the lymphatic     drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix     and blue dye in the corpus of the uterus and to investigate the identification rate of     sentinel nodes using this technique in patients with cancer of the uterus.   "
131419|NCT01565031|"     The optimal score to predict unfavourable outcome in well-controlled asthma patients who are     undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is     warranted to prospectively develop a prognostic system -easy to perform (suitable for use in     the clinical rather the research setting)- for asthmatic patients in this clinical setting.      HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in     well-controlled patients who are undergoing a step-wise down-titration of their medication     according to international guidelines.      METHODS The investigators designed a prospective, multicenter, observational study at five     centers in cities across Spain.      The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss     of control. The investigators will consider the following variables in the risk factor     analysis: documented history of previous bronchial obstruction (FEV1/FVC < 70%), coefficient     of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction     of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.      The score model will be prospectively validated in an independent set of 113 patients.   "
131420|NCT01565018|"     To investigate and compare the drug amount delivered to the body after each single     administration of Rotigotine patch with 2 different formulations in healthy Japanese     subjects.   "
131421|NCT01565005|"     The purpose of this study is to:      I. Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by     ASPM mutations already characterized and published (Passemard et al. 2009a) with other     MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT     mutations)      II. Describe the neuro-radiological and cognitive phenotype of microcephalic patients     suffering from Fanconi anemia, and compared them to subjects with:        -  Fanconi anemia but normal OFC (head circumference)        -  MCPH patients        -  Healthy control subjects Our hypothesis is that mutations in genes responsible of          microcephaly impact differentially cortical brain development and functioning   "
131422|NCT01564992|"     This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of     treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients will     be followed annually for up to 5 years. A biological collection will be associated with a     full clinical assessment of motor and non motor symptoms, medical and treatment history,     environmental factors. The association between candidate gene polymorphisms and disease or     treatment complications will be analyzed.   "
131423|NCT01564979|"     The purpose of this study is to determine whether pretarsal and preseptal techniques of     Botulinum toxin type A injection have any effect on tear functions.   "
131424|NCT01564966|"     -  A reduce in renal mass may result in remnant single nephron hyperfiltration, with          associated proteinuria and an accelerated loss of kidney function.        -  Live-donor kidney transplantation is generally considered the best choice for patients          who have renal failure and are awaiting transplantation, because these kidneys function          better than kidneys from deceased donors, and waiting times for deceased-donor          transplants are long        -  Although several studies have shown that kidney donation has low short-term morbidity          and mortality, the data on long-term outcomes are much less complete.        -  This study is designed to prospectively evaluate the effects of unilateral nephrectomy          on cardiovascular-renal functions of donors after living kidney donation: the          development of hypertension, albuminuria, renal failure, inflammatory and endothelial          changes.   "
131425|NCT01564953|"     The aim of this study was to investigate the associations between serum concentrations of     vitamin D, Magnesium and Calcium in Chronic obstructive pulmonary disease patients and the     potential impact of these parameters on lung function and quality of life.   "
131426|NCT01564940|"     The purpose of this study is to obtain subjective feedback in a home use environment     regarding usability and ease of use of the applicator and conception cap and the instructions     for use. Data will be collected and evaluation to determine if the usability requirements of     the conception system as determined by the usability specification have been met. The study     will not involve sexual intercourse or delivery of any fluids to the cervix. The study will     only involve use of the applicator to insert the cervical cap into the vagina, track it to     the cervix and prepare and release the cervical cap (with removal string attached) onto the     cervix. The conception cap will remain in place for no more than 6 hours.   "
131427|NCT01564927|"     The aims of the study are to investigate the physiological responses associated with deqi     during stimulation of the LI11 and LI4 acupuncture points and the correlation between the     intensity of the deqi sensation to such responses.   "
131428|NCT01564914|"     The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with     recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF     therapy)   "
131429|NCT01564901|"     This prospective, observational, multicenter study will assess the efficacy and safety of     RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to     severe rheumatoid arthritis and an inadequate response to previous disease-modifying     antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.   "
131430|NCT01564888|"     Evaluating the effect of ulnar artery compression while pressing on radial artery to stop     bleeding, in maintaining radial artery potency, after cardiac catheterization through the     radial artery. We prospectively plan to compare 3000 patients referred for cardiac     catheterization, randomized into two groups, one group receiving radial artery compression     for stopping bleeding, in a standard fashion following best practices, and the other group     receiving radial artery compression using standard best practices and ulnar artery     compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure     to evaluate its potency, using plethysmography.   "
131431|NCT01564875|"     Study design        -  Multicenter, double-dummy, double-blinded, randomized, Phase 4 study        -  Patients will be randomized to either a study group or a control group in a 1:1 ratio,          and will be orally administered the assigned drugs      Study Objective      -The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast     Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with     stage 3,4,5 chronic kidney disease with hyperlipidemia      Primary objective      -to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD)     stage 3,4,5 with hyperlipidemia subjects.   "
131433|NCT01564849|"     An explosion of interest in the numerous therapeutic properties of Punica granatum over the     last decade has led to numerous in vitro, animal, and clinical trials. Pomegranate is a     potent antioxidant, superior to red wine and equal to or better than green tea. In addition,     anticarcinogenic and anti-inflammatory properties suggest its possible use as a therapy or     adjunct for prevention and treatment of several types of cancer and cardiovascular disease.     Because of pomegranate's antimicrobial properties, it may aid in preventing infection by     dental pathogens, pathogenic E. coli O157:H7, and antibiotic-resistant organisms such as     methicillin-resistant Staphylococcus aureus (MRSA) Pomegranate's effect on bacterial     pathogens has only been tested in vitro, however, necessitating human trials to refute or     substantiate any clinical effect.      The possibility that pomegranate extracts may also have an effect on several other disease     processes, such as Alzheimer's and obesity, underscores the need for more clinical research.     Currently, numerous clinical trials are in progress exploring the therapeutic potential of     pomegranate extracts.      Aim The investigators want to evaluate the effect of Punica granatum components on Chronic     sinusitis, nasal polyps and chronic rhinitis.   "
131434|NCT01564836|"     This prospective study is performed to identify safer and more concrete indicators of     successful discontinuation and explore contributing factors for sustained undetectable     transcript   "
131435|NCT01564823|"     The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on     prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohn´s Disease patients     after 52 weeks of treatment.   "
131436|NCT01564810|"     In this study, the investigators assessed the effect of Cetuximab in combination with     chemotherapy in the treatment of unresectable metastatic colorectal cancer.   "
131437|NCT01564797|"     The aims of the study are to investigate        1. the effects of an intervention vs. control on levels of glycosylated haemoglobin          (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c          at baseline (>6.0%). Glycosylated haemoglobin provides an indication of blood sugar          levels over the past 3 months. Elevated hA1c levels are seen in diabetics and          pre-diabetics.        2. the effects of the intervention vs control on consumption of fresh fruit and vegetables        3. the effects of the intervention vs control on levels of physical activity   "
131438|NCT01564784|"     This study will compare the efficacy, in terms of complete responses and overall survival, of     inotuzumab ozogamicin versus investigator's choice of chemotherapy.   "
131439|NCT01564771|"     Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates     and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates     collected each year are limited and depict a certain proportion of patients who have easy     access to tertiary care or have underlying medical reasons which necessitate inpatient care.     It is also probable that the real burden of pneumococcal disease is not well estimated     especially among adults. New additions in the laboratory setting such as the pneumococcal     urine antigen assay (Binax NOW®) and the Urinary Antigen Diagnostic Assay (Luminex) for the     detection of 13 serotype specific polysaccharides in human urine developed by Pfizer might be     helpful in identifying more pneumococcal infections compared to the previous years. This NIS     is based on the unmet scientific need to describe the serotype distribution and the     resistance profile of isolates from X-Ray confirmed CAP in the present circumstances.   "
131440|NCT01564758|"     The purpose of this study is to determine if Linezolid is safe for adult Filipino patients     diagnosed with gram positive infections.   "
131441|NCT01564745|"     In our knowledge there is only few data about the cough determinants in mechanically     ventilated patients. However some failure of extubation is due to inefficiency cough. In     order to determine some determinants of cough, the investigators propose to evaluate     systematically different physiological parameters before and after extubation.   "
131442|NCT01564732|"     The purpose of this study is to compare plicated laparoscopic adjustable gastric banding     (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospective     randomized clinical trial. We hypothesize the plicated procedure will provide greater short-     and long-term excess weight loss than the standard procedure. There exists little prospective     randomized data regarding this topic and the recent position statement from the American     Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study. Further     information on background and design of this study are provided in the detailed description.   "
131443|NCT01564719|"     This study seeks to test a two-year intervention designed for United Methodist clergy. The     intervention consists of: the stress reduction program Williams LifeSkills, adapted for     clergy; the 10-session online weight loss program Naturally Slim Foundations plus its     7-session online booster program, Naturally Slim Advanced; monthly phone conversations with     Wellness Advocates who function as health coaches; and three in-person workshops that cover     the theology of the body and incarnation and provide the religious rationale for caring for     the mind and body. Participants were randomly assigned to one of three cohorts, all of which     will eventually receive the intervention but which differ by intervention timing, thereby     building in a randomized waitlist control group. The investigators hypothesize that     intervention participants will achieve reductions in metabolic syndrome, depression, and     stress, and achieve improvements in quality of life and spiritual well-being, compared to the     waiting control group participants.   "
131444|NCT01564706|"     This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed     throughout the body.   "
131484|NCT01564303|"     CIAKI is a common iatrogenic. Up to date the suggested treatments for CIAKI are partially     effective and have not been approved by the Food and Drug Administration yet. The lack of     effective nephroprotective drug for CIAKI, emphasizes the need not only for additional new     drugs but also for new strategies that might also clarify CIAKI pathophysiology. To the best     of our knowledge, the potentially beneficial effect of carnitine and PDE5 inhibitors on CIAKI     prevention has not been examined, so far.   "
131485|NCT01564290|"     The purpose of this study is to determine the effect of probiotic yogurt in acute watery     diarrhea in children. The investigators will compare the effect of two different probiotics     products.   "
131626|NCT01562132|"     The purpose of this study is to determine if treatment with two medicines in combination     (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for     the treatment of an early infection with a fungus called cryptococcus.   "
131445|NCT01564693|"     The pathogenesis of cancer anorexia is complex and multifactorial. However, a number of     consistent and robust evidence point to a prominent role for the central nervous system. In     particular, the hyperactivation of the immune system, due to tumour growth, causes a systemic     inflammatory response primarily mediated by pro-inflammatory cytokines. At the central level,     inflammatory response profoundly alters the activity of the hypothalamic nuclei, which are     involved in the regulation of energy homeostasis. In particular, pro-inflammatory cytokines     inhibit prophagic neurons activity, while enhance the activation of the anorexigenic neurons.     Although supported by compelling experimental evidence, it should be acknowledged that this     pathogenic hypothesis has not been confirmed yet by human studies.      Aim of the present study is to determine the specific pattern(s) of the brain activation     after assumption of a standard meal in both anorexic and non-anorexic cancer patients to     reveal potential differences, which will be correlated with the levels of concurrently     measured circulating pro-inflammatory cytokines. The results obtained would help in assessing     the role of the central nervous system and, in particular of the hypothalamus, in the     pathogenesis of cancer anorexia.   "
131446|NCT01564680|"     Background: The aim of this prospective, randomized, double-blind study is to determine the     most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain     relief after lower abdominal surgery.      Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were     randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol     1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam     group). Additionally pain was treated postoperatively using morphine patient-controlled     analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine     consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours     postoperatively.   "
131447|NCT01564667|"     Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either     Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a     placebo control condition not designed to change attention patterns. Outcome measures will be     PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological     interviews and questionnaires. Participants will also be invited to participate in     physiological testing before and after receiving AMBT or placebo to serve as additional     outcome measures and assess brain functioning, heart rate, and muscle tension.      The investigators expect to see significant PTSD symptom reduction in the Attention Bias     Modification Treatment (ABMT) group relative to the placebo control group in which no     symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we     will offer active ABMT to those participants randomly assigned to the placebo arm if they     would like to receive the treatment.   "
131448|NCT01564654|"     This study involves retrospective collection of data regarding the first approximately 100     iTotal Knee Replacement System surgeries and their short term outcomes at a small set of     centers throughout the US.   "
131449|NCT01564641|"     To evaluate the ConforMIS iDuo G2 implant   "
131450|NCT01564628|"     The purpose of the study is to optimize an already existing algorithm for diagnosing     atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).   "
131451|NCT01564615|"     The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the     occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.   "
131452|NCT01564602|"     The main objective of this trial is to assess the efficacy and safety of single port-access     laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood     loss and hospital stay will be record, respectively. The pain score is based on the visual     analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours     after surgery.   "
131453|NCT01563354|"     This is a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a     single-stage design in each arm. The purpose of this study is to test the effectiveness and     safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with     advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the     lung and thymus. It is expected that a total of 120 patients with 40 patients in each arm     will be enrolled into this study. Patients with disease control (SD or better) in the     combination arm or monotherapy with pasireotide LAR and everolimus and who are not     experiencing unacceptable toxicity are permitted to continue treatment after the 12 month     treatment period in the extension phase of the study. Primary Endpoint is defined as the     proportion of patients who are progression-free at 9 months according to RECIST V 1.1   "
131454|NCT01563341|"     Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus     potentially improve cognitive function in patients with Parkinsons disease.   "
131455|NCT01563328|"     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3     clinical development for the treatment of human immunodeficiency virus (HIV) infection.     Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is     expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and     Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently approved     by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have rapidly been     adopted to standard of care in combination with pegylated interferon and ribavarin. This is     a single-center, open-label, two-cohort, two-period, one-way, study in healthy adult     subjects. A total of approximately 32 subjects will be enrolled, in order to obtain 24     evaluable subjects (12 per cohort). In the first treatment period, all subjects will receive     DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will receive DTG 50 mg     once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750 mg q8h (treatment     C) for 10 days. There will be no washout between treatments. Safety evaluations and serial PK     samples will be collected during each treatment period.      Subjects will have a screening visit within 30 days prior to the first dose of study drug,     two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.      This study will be conducted at one center in the US, with healthy adult male and female     subjects.   "
131456|NCT01563315|"     The purpose of this study is to determine the etiology of community-acquired pneumonia, to     assess risk factors and to investigate potential prognostic biomarkers of serious disease and     fatal outcome.   "
131459|NCT01563276|"     The purpose of this study is to better understand why individuals with Progressive     Supranuclear Palsy (PSP) fall. Understanding the mechanism of gait and balance dysfunction in     individuals with PSP may provide us with important early diagnostic tools, allowing for     earlier identification of mobility problems and to better evaluate medical therapies aimed at     improving motor disability.      The investigators will recruit 10 PSP, 10 PD and 10 healthy controls for the study. All     subjects will be asked to come to the OHSU clinic at the Center for Health and Healing for an     initial screening visit. They will meet with the primary investigator to conduct a brief     interview and physical examination. In addition, they will be asked to answer questions     regarding current and past medical illness, how often they fall and what kinds of medications     they are on.      Subjects who agree to participate will come to the Oregon Clinical and Translational Research     Institute (OCTRI) at OHSU for balance testing. Subjects will be asked to stand or sit on a     movable platform with eyes open or closed. Prior to standing on the platform, the     investigators will place 6 small sensors on body which are held in place by velcro straps     (one on each wrist, ankles, chest and lower back). The platform will then be moved (tilt or     slide) while subjects try to keep their balance. During all of the balance tests described     above, body movements will be recorded from the sensors on the subjects' body. This data is     directly recorded by a computer and analyzed to help us gain better understanding of the     subjects' posture and their ability to remain up right.   "
131460|NCT01563263|"     This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase     II/III study. The study population consists of male or female intensive care unit (ICU)     patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and     80 years.   "
131461|NCT01563250|"     By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the     investigators can effectively reduce ED wait times and ED length of stay by decreasing     overall hospital admissions and telemetry admissions. In addition, the investigators     hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by     increasing the patient to health care provider ratio.   "
131462|NCT01563237|"     To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma     that is inadequately controlled on maximum tolerated medical therapy with intraocular     pressure ≥ 18 mm Hg and ≤ 40 mm Hg   "
131463|NCT01564576|"     The aim of the present study is to prospectively assess whether deep neuromuscular blockade     (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses     using a nerve stimulator monitoring) until the end of surgery, followed by sugammadex     (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end     of surgery followed by neostigmine (Prostigmin®, Vagostigmin®) reversal, in patients     undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep     NMB throughout the procedure creates better conditions for surgery, while reversal of deep     NMBwith sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer     postoperative respiratory events as compared to neostigmine (Prostigmin®,     Vagostigmin®)reversal. Participants will be followed for the duration of hospital stay, an     expected average of 7 days.   "
131464|NCT01564563|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in     patients having undergone a hematopoietic stem cell transplantation.   "
131465|NCT01564550|"     In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics     in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The     kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The     investigators hypothesis is that the investigators will find an increased VLDL1 production in     type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish     to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where     the investigators expect less variance in VLDL production when the subject is given an     isocaloric diet.   "
131466|NCT01564537|"     The purpose of this study is to determine whether the addition of oral ixazomib to the     background therapy of lenalidomide and dexamethasone improves progression free survival (PFS)     in participants with relapsed and/or refractory multiple myeloma (RRMM).   "
131467|NCT01564524|"     Traumatic facial injuries, especially those sustained in military combat, are characterized     by destruction of bone and soft tissue. While the bony structures of the face can be     reconstructed, it is difficult to return the soft tissue back to its original form. Many     times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of     improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat     is taken from areas throughout the body, usually the thighs or abdomen, with a small     liposuction tube. The fat is then transferred into the area that has lost volume or fullness.     The fullness of the soft tissue area may decrease over time because the transferred fat can     be reabsorbed by the body. Altering the current fat grafting procedure, slightly, could lead     to less reabsorption and a lasting fullness of the soft tissue area outcome of the fat graft     procedure.      We are conducting this research study to help us improve the surgical treatment of people who     have suffered facial soft tissue loss as a result of trauma. The goal of this research study     is to see how each person's fat grafts will maintain the fat over time and to measure the     quality of life during a 9 month post-surgical follow-up period. The total duration of     participation is approximately 11 months.      In this study, we will concentrate the fat in the fat grafting procedure to determine whether     this process will maintain the fat over time. The areas treated with enhanced fat grafts will     be compared with areas treated with standard of care fat grafts. At least two areas of your     face will be treated with fat grafts, (standard of care fat grafts and concentrated fat     grafts).   "
131468|NCT01564511|"     Multiple Sclerosis is a very disabling disorder in young adult patients leading to an     important limitation in daily life activities and social participation. Among of the     different causes of disability in MS patients gait impairments, fatigue and balance disorders     can be considered as the main concerns. Thus, gait restoration in patients with MS is the one     of the primary objective of rehabilitation and often influences whether a patient can return     home or to work. Even if potentially innovative treatments like treadmill training have been     proposed, nowadays the role of robotic assisted locomotion rehabilitation has not been     extensively studied in patients with MS.   "
131474|NCT01564433|"     Cerebral Palsy (CP) describes a group of chronic conditions affecting body movement and     muscle coordination caused by damage to one or more areas of the brain, usually occurring     during fetal development or infancy. One of the most disabling mobility impairments in CP is     gait impairment, clinically characterized by reduced speed and endurance, as well as reduced     step, stride length and toe clearance during gait.      Recently, gait rehabilitation methods in patients with neurological impairment have relied on     technological devices, which drive the patient's gait in a body-weight support condition and     emphasize the beneficial role of repetitive practice. Early studies in gait rehabilitation in     patients with CP were carried out by using partial body-weight support treadmill training     (PBWSTT) and robotic-assisted treadmill therapy. Despite their potential, these technologies     have practical limitations in their routine application.      More recently, several studies have focused on the use of a new electromechanical gait     trainer (Gait Trainer GT I; Reha-Stim, Berlin, Germany) in adult patients who have     experienced a stroke. They have shown that training with this device may significantly     improve gait performance. Despite the clinical impact of this new rehabilitative procedure,     to date, no studies have been conducted on its use in children with CP.   "
131475|NCT01564420|"     The currently available data are insufficient to develop a model that achieves optimum     morphine dose individualization at the postoperative period of coronary artery bypass     grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could     justify morphine consumption, drug plasma concentration and pain intensity during the     postoperative period after CABG and evaluate the post operative pain.   "
131476|NCT01564407|"     The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment     of stable, restrictive scars in subjects who have suffered a burn injury. Evaluation will be     achieved through regular assessment of adverse events, vital signs, blood work monitoring and     laboratory analysis cellular properties of the scar through biopsy.      The secondary objectives of this study are to evaluate improvement in symptoms of scars     including reduced pain, discomfort and itching, improvement in mobility and daily function,     improvement in appearance and scar texture.   "
131477|NCT01564394|"     Aim 1: Assess the feasibility, safety and efficacy of a Qigong intervention in elderly     prostate cancer survivors.      Describe participation, retention, and adherence rates and assess reasons for participation,     attrition, and non-adherence.      Identify effective recruitment and retention strategies. Ascertain participants' level of     satisfaction and additional perceptions of the experimental and control interventions,     perceived study burden, study design, and implementation.      Aim 2: Provide preliminary data on potential effects of Qigong vs. non-aerobic stretching     exercises on fatigue, psychosocial outcomes, and health-related quality of life in     preparation for a future R01 application for a larger, definitive randomized controlled     trial. Hypothesis: Qigong participants will have improved fatigue levels, quality of life,     and related psychosocial and health outcomes compared to those randomized to the non-aerobic     stretching group.   "
131478|NCT01564381|"     The investigators hope to learn if resveratrol supplementation can be beneficial for the     cardiovascular system. Seeing that resveratrol is rapidly metabolized, the investigators are     interested in learning if a novel form of resveratrol, ResA, which is a mixture of     resveratrol with amino acid, may have greater bioavailability and lead to greater improvement     in vascular function, compared to standard resveratrol supplement.   "
131479|NCT01564368|"     RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI)     and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating     how well patients with breast cancer respond to treatment.      PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in     patients with breast cancer undergoing neoadjuvant chemotherapy.   "
131480|NCT01564355|"     Chronic rhinosinusitis (CRS) is an inflammatory condition of the nose and sinuses. It affects     about 5 to 10% of Canadians. Patients suffer from congestion in the nose and sinuses, nasal     discharge, pressure in the face, and a reduced sense of smell. This affects people's     enjoyment of life. Medical management uses sprays or pills to treat these symptoms but for     some patients sinus surgery is needed. This type of surgery is called endoscopic sinus     surgery (ESS).      There is no single correct approach to take care of patients after sinus surgery. Most     experts would use a nasal spray and a short-course of oral steroid pills to reduce sinus     swelling and minimize complications related to scarring.      Steroid-eluting nasal spacers are devices placed inside the sinus during surgery and slowly     release topical steroids into the sinuses better than steroid sprays. These spacers have     been shown to improve results following sinus surgery. When using these special spacers,     there may no longer be a need for oral steroid pills following surgery. This would help to     avoid potential side effects associated with these medications.      The purpose of this study is to find out whether taking oral (systemic) steroid pills     following sinus surgery is necessary to improve surgical results, now that steroid-eluting     nasal spacers are commonly used during surgery.   "
131481|NCT01564342|"     This study is designed to compare the infection rates in wounds irrigated with sterile normal     saline to those irrigated with chlorinated tap water. The hypothesis is that the wound     infection rate subsequent to irrigation with tap water is not significantly different than     the infection rate for wounds irrigated with sterile normal saline.      Inclusion criteria are patients older than 1-year of age who present to the emergency     department with a soft-tissue laceration requiring repair. Exclusion criteria include     patients with any underlying immunocompromising illness, current use of antibiotics, puncture     or bite wounds, underlying tendon or bone involvement, or wounds more than nine hours old.      Patients are randomized to have their wounds irrigated either with tap water or sterile     normal saline prior to closure, controlling for the volume and irrigation method used.     Structured follow-up is completed at 48 hours and 30 days to determine the presence of     infection.      The primary outcome measure is the difference in wound infection rates between the two     randomized groups.   "
131482|NCT01564329|"     To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time     sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window     period.   "
131483|NCT01564316|"     Using to method of Proteomics, for aims to conquer intractable disease, try to access variety     experiment. Biomarker is necessary to develop new diagnosis method and target of treatment.   "
131488|NCT01564251|"     This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety,     tolerability, and pharmacokinetics (PK) of GDC-0575 administered alone or in combination with     gemcitabine in participants with refractory solid tumors or lymphoma. In Stage 1, cohorts of     participants will receive multiple ascending oral doses of GDC-0575 alone or in combination     with intravenous gemcitabine. In Stage 2, participants will receive GDC-0575 orally in     combination with intravenous gemcitabine at or below the maximum tolerated dose determined in     Stage 1. Anticipated time on study treatment is until disease progression or unacceptable     toxicity occurs, up to approximately 5 years.   "
131489|NCT01564238|"     Optimal calcium retention is important for building bone mass within the genetic potential, a     key to reducing risk of osteoporosis later in life. Calcium retention is high during the     rapid growth period. The investigators know that urinary calcium is affected by sodium intake     but the investigators do not know the effects of sodium intake during the growth spurt or the     differences in calcium retention between blacks and whites. Our hypothesis was that a high     dietary sodium increases the calcium intakes required for optimal calcium retention in both     black and white adolescent girls. The investigators tested calcium retention while girls     consumed a low and high sodium diet during three week periods. The subjects were housed in a     Purdue fraternity house during the summer and they were supervised at all times by trained     staff. During the summer of 1999, subjects consumed diets with 2 levels of dietary Na+ with a     fixed diet low in calcium. On the next summer, they switched to a high calcium diet. Subjects     collected fecal and urine daily for 20 days. Other measurements included daily body weight,     blood pressure every other day, blood sample at the end of each session. Baseline measures     included bone mass, self-assessment of pubertal development, a physical examination and diet     history.   "
131490|NCT01564225|"     Following discussions with the FDA, a Phase 1 safety study is being initiated in X-Linked     Hypohidrotic Ectodermal Dysplasia (XLHED)-affected adults to develop safety and exposure data     for EDI200 in anticipation of dosing XLHED-affected neonates. Selecting XLHED-affected adults     for this study provides a genetic match and biologic relevance to XLHED-affected neonates.     Both males and females will be enrolled, providing safety experience with EDI200 that will     inform the planned neonate study as well as supportive data for potential future trials of     antenatal EDI200 administration.   "
131491|NCT01564212|"     With approval of the IRB at the Cleveland Clinic and written informed consent, the     investigators propose to study up to 20 healthy volunteers in the protocol below as this will     allow for drop-outs. As the investigators believe that 10 volunteers will provide sufficient     power to detect clinically-meaningful differences between laminar air flow treatments.      The study has been designed to find out whether heat loss increases significantly in laminar     air flow operating rooms. Furthermore the investigators will find out whether active warming     minimizes this heat loss. Increased heat loss increases the amount of perioperative     hypothermia. It has been shown that perioperative hypothermia is associated with severe     complications such as an increased incidence of surgical wound infections. On the other hand     laminar air flow is explicitly used to decrease air-borne infections. Our study results will     help to optimize thermal management of orthopedic patients.   "
131492|NCT01564199|"     The objective of the study is to assess the extent to which the charcoal prevents the     absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on     comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).   "
131493|NCT01564186|"     The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac     hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class     assessment and echocardiographic measurements are performed at 3 months and 12 months     post-implant to characterize long-term effect of MPP.   "
131494|NCT01564173|"     The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at     each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with     impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic     function will be assessed during a pacing protocol with a pressure catheter inserted in the     LV.   "
131495|NCT01564160|"     A marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna     canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids.      The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day)     bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population of     healthy adult participants.   "
131496|NCT01564147|"     Taking into account the recommendations of the Health Authority [1] and the application of     patients' associations, we have structured a course of therapeutic education includes three     stages for patients with rheumatoid arthritis and followed at Nantes University Hospital.     Step 1: initial interview with a nurse patient education for diagnosis and education with the     patient to choose three subjects from among 10 offered him problematic; Step 2: Orientation     in an educational path that provides access to 6 months group workshops (3 maximum) and / or     interviews tailored to the three selected topics; Step 3: final interview with a nurse said     therapeutic education formative assessment to take stock. The main objective of our work is     to ensure that the patient finds it easier solutions to the three problematic topics him     after 6 months of education after six months without treatment.   "
131497|NCT01564134|"     An interventional study will be performed in subjects aged 1-65 years old to evaluate effects     of different doses of hepatitis B vaccines in low or non-response population.   "
131512|NCT01563939|"     Epidural analgesia for pain relief in labor may not be suitable for all patients, and     intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative.     The purpose of this study is to assess the effectiveness of two methods remifentanil     administration in the form of either an infusion or PCA demand bolus (intravenous injection     of a single dose over a short period of time). Currently, our hospital gives remifentanil by     demand bolus, however it may be equally effective, with less side effects, to give the drug     as an infusion.   "
131513|NCT01563926|"     This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid     somatropin formulation in children with growth hormone deficiency.   "
131514|NCT01563913|"     The purpose of this research study is to measure the safety (side effects) of an Omega 3     Fatty acid called docosahexanoic acid (DHA) and measure the dyskinesia (involuntary     movements) in Parkinson 's disease (PD).   "
131498|NCT01564121|"     The giant cell tumor (GTC) is an aggressive benign bone tumor, growing at the     metaphyseal-epiphyseal regions of long bones, especially around the knee and the distal     radius.It is responsible for bony destruction in para-articular zone fracture and leading to     the breakdown and destruction of the underlying joint.      Histologically, the tumor cell contains a contingent of monocytic cells round, a contingent     of giant type cell of type osteoclastic responsible for bone resorption that accompanies     these tumors and a contingent of lengthened cells fibroblast-like considered to be contingent     tumor.      The treatment is exclusively surgical; or by resection of the lesion which takes away tumour     and its environment, solution which, if it prevents local recurrence, imposes an important     bony and articular reconstruction, always limited and deteriorating rapidly over time in     these young patients; or by curettage of lesion, by hollowing-out of the bone, creating a     hole which it will be necessary to fill up by a bony grafting or a substitute of the bone     (cement). This last solution, if it preserves a better function, exposes at risk of local     recurrence,putting into play the prognosis of articulation near, most often the knee.Despite     different local adjuvants treatments used during surgical operation, after having curetted     the cavity and before filling it up, the recidivism rates vary from 12 % to 41 % (average 25     %) in literature.      The beneficial effect of the adjuvants therapeutics suggests the concept broadly accepted by     a tumoral microscopic residual at the origin of the local recidivism .Biphosphonates (BP) is     molecules which settle in vivo on the hydroxyapatite of the bone; they inhibit the     recruitment of the osteoclast forerunners and the activity of mature osteoclast. Besides,     biphosphonates containing some nitrogen (N-BP), leads to the apoptose of mature osteoclast.     These molecules also have a direct effect on tumor cells , causing apoptosis of neoplastic     cells of myeloma, of breast cancer. Clinical controlled studies confirm the experimental data     of N-BP. Two work also showed their effect on osteoclasts and stroma cells of tumours with     giant cells but no clinical study assessed potential on the prevention of the local     recurrence.      The investigators offer a study phase 2 of the effectiveness of N-BP (acid zoledronique) on     the prevention of the local recurrence of tumours with primary huge cells after surgical     treatment by curettage - filing by a surgeon referent in oncologic orthopedic surgery.      Number of patients: 24   "
131499|NCT01564108|"     Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment     of a variety of retinal diseases. This study addresses a condition which affects a large     number of our patients in whom the investigators face difficult management decisions. These     patients with uveitis are severely disabled with visual loss related to cystoid macular     oedema (CMO) and few options remain when standard treatment has either failed or is     contraindicated.      The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis     is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is     hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will be     more effective in improving quality of life by reducing macular thickening and restoring     visual function.   "
131500|NCT01564095|"     Utilisation of extended criteria donors due to critical organ shortage contributes to     increased ischemia reperfusion injury as well as mortality following liver transplantation.     Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using     the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse.     Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver     transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic     injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of     the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on     cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs     according to Eurotransplant's definition of EDC grafts.   "
131501|NCT01564082|"     Patients presenting for elective surgery will be randomized to having the breathing tube     inserted partly into the throat prior to GlideScope insertion, or having it inserted fully     after GlideScope insertion.   "
131502|NCT01564069|"     Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain     will report no improvement treatment efficacy when compared to patients with chronic pain     managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients     with intrathecal delivery systems for chronic non-cancer pain will report no improvement in     treatment efficacy when compared to patients with chronic pain who are managed with     non-opioid therapies.   "
131503|NCT01564056|"     The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall     survival for elderly patients with breast cancer, in a sub group with a high risk of relapse     according to Genomic Grade test.   "
131504|NCT01564043|"     Higher levels of physical activity are associated with better functional status, fewer     hospital admissions, and lower mortality. The investigators studied the feasibility and     safety of a novel program that combines a pedometer with a website to increase walking. This     is a pilot study.   "
131505|NCT01564030|"     Solid food or fluid residue in the stomach is always a major concern when patients need     medical procedures under sedation or general anesthesia, due to the high risk of pulmonary     aspiration of the stomach contents. This is especially important in emergency procedures,     when a fasting period is not observed. The aspiration of the stomach contents into one's     lungs can lead to serious complications (such as severe respiratory failure). Information     from a bedside ultrasound assessment of the stomach may be a very useful tool to decide     whether or not it's safe to proceed, cancel or delay a surgical procedure.   "
131506|NCT01564017|"     As part of the registration plan of our products and after performing a Phase I study the     present trial has been designed to compare the efficacy of 5 different doses of subcutaneous     immunotherapy in depot presentation.   "
131507|NCT01564004|"     Does clinical hypnosis or neuro-linguistic programming improve the success rate of external     cephalic version?   "
131508|NCT01563991|"     Subjects undergoing surgery on the small or large bowel will be randomized to one of 2     groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact     of this change on recovery after surgery.   "
131509|NCT01563978|"     The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on     ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a     disease-modifying anti-rheumatic drug (DMARD).      The study will last for 57 days.   "
131510|NCT01563965|"     Prolonged pre-operative fasting increases postoperative hospital stay and current evidence     recommends carbohydrate (CHO) drinks 2 hours before surgery. Our hypothesis is that the     addition of hydrolized protein to a CHO-based drink not only reduces the inflammatory     response but also diminish hospitalization.   "
131511|NCT01563952|"     Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates,     because lumen and stent dimensions can be accurately determined by intravascular ultrasound     (IVUS).   "
131553|NCT01563081|"     To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients     aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin     diseases.   "
131515|NCT01563900|"     Fatigue is a symptom present in 76 to 92% of people with multiple sclerosis (MS). Fatigue is     usually described as an overwhelming sense of tiredness, lack of energy, and feeling of     exhaustion which is different from sleepiness. Fatigue is also a symptom commonly seen in     people with obstructive sleep apnea (OSA). The overall objective is to develop a     non-pharmacological treatment for fatigue in MS. The objective of this study is to evaluate     if treatment of OSA with continuous positive airway pressure (CPAP) improves fatigue in MS     subjects with OSA and fatigue. This will be a small pilot randomized, double-blind,     sham-controlled clinical trial; the control group will be treated with a sham-CPAP machine     and intervention group will be treated with an auto-titration CPAP machine. The primary     outcome measure will be improvement (decrease) in the Modified Fatigue Impact Scale from     baseline. The duration of intervention will be 12 weeks to achieve a clinical response in the     treatment group. After this intervention participants in both groups will be offered a     referral to the sleep clinic of their preference for formal treatment as per standard of     care.   "
131516|NCT01563887|"     This study will recruit drivers with Type 1 diabetes from across the U.S. and assign them to     four groups based on their presumed risk level- routine care low risk, routine care high     risk, or to one of two Internet interventions focused on reducing hypoglycemia driving. All     subjects will be followed for two years to determine whether and which intervention was most     effective at reducing hypoglycemia related driving collisions.   "
131517|NCT01563874|"     BACKGROUND:      Lymphomas are comprised of a diversity of tumors with different pathologic and clinical     features. While distinct differences in gene expression profiles have been elucidated in     different lymphomas, there has been inconsistent correlation with the few published proteomic     studies.      Greater insights into the biology of lymphomas may be achieved by integrating current genomic     information with additional studies focused on the interrelationships in tumors of the     patterns of chromatin protein expression, chromatin protein modification, and RNA expression     profiling (both within bulk tumor and within specific microscopic tumor niches accessible by     microdissection and cell sorting approaches).      OBJECTIVES:      The goals of this protocol are to identify the global levels of all histones (including     variant histones) and non-histone chromosomal proteins, and to measure the relative levels of     most known covalent modifications on histone and non-histone chromosomal proteins.      For a limited number of cases illustrative of selected pathological entities, we propose to     map the genome-wide distribution of those modifications judged to be biochemically     instructive.      ELIGIBILITY:      This work will involve the analysis of a broad panel of lymphoma and lymphoid samples, which     were previously procured under multiple protocols at the NIH, and for which there is excess     tissue available for research. We also request permission to extend this analysis to surplus     materials to be accrued under existing protocols, upon completion of all superseding     diagnostic tests and medical/scientific studies. The criteria for inclusion in this study are     subsumed under the enveloping protocols. The number of cases to be included is dependent upon     the size of these protocols; because statistical significance improves with increasing     numbers. We hope to include up to 300 cases.      DESIGN:      Lysates from surplus samples will be prepared and arrayed onto microarrays.      These arrays will be probed with panels of protein and modification specific antibodies.      The antibody reactivity will be quantified and samples will be subjected to statistical     analysis, especially hierarchical clustering to correlate patterns of reactivity with     clinical and histological features.      Representative cases for which sufficient surplus tissue remains will be subjected to     ChIP-Seq to map the distribution of modifications across the genome.   "
131518|NCT01563861|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer. It may also help     doctors find better ways to treat cancer.      PURPOSE: This research trial studies genes in samples from patients with limited and advanced     diffuse large B-cell lymphoma.   "
131519|NCT01563848|"     The investigators hypothesized that revealing the incidence of AF following RFA of the CTI     and cryoablation PVI reduces incidence of AF following RFA of the CTI.   "
131520|NCT01563835|"     There has been very little investigation into the management of pain from 2nd trimester     termination of pregnancy or unexpected fetal loss. The standard of practice in North America     is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as     fentanyl. The goal of this study is to compare the quality of recovery after termination of     pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard     of care for live births. The study will be conducted as a randomized controlled trial.   "
131521|NCT01563822|"     Background:      Traditionally during ovum pick-up in ICSI, we aspirate the follicles for oocyte retrieval but     unfortunately we don't make use of the follicular fluid (FF) and we discard it in spite of     the fact that this does not happen in nature. The fallopian tube picks-up the FF with the     oocyte during ovulation. As this fluid contains stem cell factor and C-Kit receptor     responsible for implantation and IGF responsible for endometrial growth and TGF that improves     implantation. That's why flushing the endometrial cavity with FF after ovum pick-up might     improve endometrial receptivity and implantation rates; the limiting step in ICSI.      Patients and Methods:      100 patients attending kasr El-Aini IVF center preparing for ICSI cycles are randomized into     two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular     fluid surrounding mature oocytes through an IUI catheter is done after ovum pick-up While in     the control group, no flushing of the endometrial cavity with FF is done. The implantation     rates and pregnancy rates in both groups will be assessed.   "
131522|NCT01563809|"     Basing the investigators study on the evidence that basal serum androgens decrease with age,     the investigators hypothesize that women with serum androgens below a certain level could be     the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective     of the present study is to explore the relationship between basal serum androgen levels and     the need of LH for Controlled Ovarian Stimulation (COS) in IVF.   "
131523|NCT01563796|"     The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in     the urine of patients suspected of having bladder cancer. The measurement of urine DEK     protein, relative to an established cut-off, is correlated with the presence or absence of     bladder cancer.   "
131524|NCT01563783|"     This Post Market study is being conducted to compare the direct and indirect cost of three     approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of     symptomatic uterine fibroids.   "
131525|NCT01563770|"     Rationale: Extracts of the plant Salvia miltiorrhiza (Danshen) have been used as traditional     Chinese medicine in the treatment of cardiovascular diseases, such as angina pectoris and     myocardial infarction. Several preclinical studies point towards promising effects of Danshen     on risk factors of atherosclerotic cardiovascular diseases, such as hyperlipidemia and     hypertension.      Objective: Our primary objective is to determine the effect of Salvia miltiorrhiza extract     (Danshen) on hyperlipidemia. Secondary objective is to investigate the effect of Danshen on     hypertension. Further objectives are to determine its effect on endothelial function,     oxidative stress, inflammation, hemostasis and hemorheology, and on insulin sensitivity.   "
131526|NCT01563757|"     The investigators are studying what causes Plastic Bronchitis and Protein Losing Enteropathy.     The investigators think that these problems are from too much of two small proteins called     Vasoactive Intestinal Peptide (VIP) and Substance P. VIP and Substance P are important     proteins in the body that normally tell the body to make small amounts of fluid and they help     the intestines work. Normally, VIP and Substance P are made in the intestines and then     destroyed in the lungs after they do their normal work. The investigators think that kids who     have Plastic Bronchitis and/or Protein Losing Enteropathy who also had the Fontan surgery     might have too much VIP and Substance P in their bodies. The investigators think this causes     too much fluid to go in the lungs and too much protein in the intestines.   "
131527|NCT01563744|"     Adequate bowel preparation is of critical importance for colonoscopy. Particularly among     hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient     intolerance to prescribed laxative regimen, elderly population, and co-existing conditions     that impair the ability to ingest a large-volume laxative regimen. Improvements in bowel     preparation for colonoscopy in hospitalized patients would likely improve patient care and     reduce hospital costs. The purpose of this study is to determine if administering a portion     of the bowel purgative via EGD could improve colonoscopy preparation in hospitalized     patients.   "
131528|NCT01563731|"     Stroke is one of the major causes not only of mortality, but of disease burden worldwide,     because of residual disability and cognitive decline. Although blood pressure lowering has     been clearly shown to be the most effective means for primary and secondary prevention of     stroke, the systolic blood pressure (SBP) levels to achieve by treatment in order to optimize     prevention results are unknown, and whether SBP levels lower than those usually recommended     are accompanied by further or reduced benefits is undecided yet. Likewise, while low-density     lipoprotein cholesterol (LDL-C) lowering by statins has been shown to be associated with     primary and secondary stroke prevention, whether more intense lowering is or is not of     further benefit is unknown. The Stroke in Hypertension Optimal Treatment Trial (ESH-CHL-SHOT)     is a factorial 3 x 2 arm, multicenter, randomized clinical trial designed to test the     hypothesis that in elderly patients at high risk of recurrent stroke (previous recent stroke     or TIA) antihypertensive treatment programs aimed at reducing SBP to the usually recommended     values (< 145 to 135 mmHg), to a lower goal (< 135 to 125 mmHg) or to even lower values (<     125 mmHg) will result in progressively greater reductions in recurrent stroke, incidence of     cardiovascular outcomes and cognitive decline. Parallely, the preventive efficacy of more and     less intense LDL-C reductions will be tested on the same outcomes.   "
131529|NCT01563718|"     Naltrexone is a medication that has been shown to help prevent relapse to opioid addiction     and it has been reported to be clinically effective in parolee populations although it is     rarely used. Recently a depot formulation with one-month duration has received FDA approval     for the treatment of alcoholism and opiate dependence. This means that rather than having to     take medication daily, individuals can receive one injection that lasts for approximately 30     days. The purpose of this study is to determine whether this monthly injection of naltrexone     is practical and useful in the prevention of relapse to opioids and re-incarceration when     administered to inmates prior to release from prison. The investigators will also monitor HIV     risk behaviors to determine whether the intervention reduces risky behaviors associated with     intravenous drug abuse and the spread of viruses such as HIV and hepatitis C. Volunteers will     be randomized to receive an injection of depot naltrexone prior to release from prison or to     contact study personnel in the community following release. Participants assigned to receive     naltrexone in prison will receive 1 injection in prison, and 5 additional monthly injections     for 5 months upon release. Participants assigned to contact study personnel upon release will     receive all 6 injections in the community at RIH after their release from the ACI. Patients     in both groups will be given identical follow up monthly for six months including measures of     opiate use by self-report, and urine tests. An additional scheduled urine test will take     place each month between monthly visits. There will also be a 12-month follow-up period for     participants in both groups, which will consist of 2 visits, spaced 6 months apart, meaning     that participants will be enrolled in the study for a total of about 18 months. All     participants will be asked to complete brief questionnaires at follow-up visits to assess     things such as services received, drug use, and depression.   "
131530|NCT01563705|"     The aim of this study is to improve knowledge of natural history and methods of monitoring     the evolution of Glycogen storage disease type III regarding the muscle and to study the     prospective approach of large series of patients, and using the same protocol for the follow     up of the children and adults.   "
131531|NCT01563692|"     Respiratory Syncytial Virus (RSV) is a human restricted pathogen and is the single most     important cause of severe respiratory illness in infants and young children, a major cause of     infantile bronchiolitis and is the most frequent cause of hospitalization of infants and     young children in industrialized countries. Severe RSV infection early in life is associated     with an increased risk of subsequent recurrent wheezing and asthma. There are few     population-based estimates of the incidence of RSV disease from developing countries, but the     existing data clearly indicates that the virus accounts for a high proportion of Acute     Respiratory Infections (ARI) in children. Studies in Brazil, Colombia and Thailand suggest     that RSV causes 20-30% of ARI cases in children from 1-4 years of age, a proportion similar     to that in industrialized countries, and WHO has estimated the global RSV disease burden at     64 million cases and 160 000 deaths every year. RSV also causes severe disease in elderly and     immune-compromised adults, and the burden of RSV disease in the elderly is comparable to that     of seasonal influenza. The economic impact of RSV-related disease in adults estimated to be     greater than that of influenza in relation to numbers of days lost from work.      The development of a safe and effective vaccine against RSV would benefit greatly from data     on the immune responses in healthy adults naturally exposed to the virus. RSV infection has     been shown to increase and induce short-lived circulating antibody secreting cells and     produce an increase in the RSV specific antibody titres but very limited data is available on     the cellular immune responses induced by RSV during natural infection in healthy adults. The     existence of cell mediated immune response against RSV in humans has been described but     characterization of this response remains poor and simultaneous analysis of several     immunological parameters have not been attempted in an RSV exposed population before.   "
131532|NCT01563679|"     This is a study involving patients with cancer who are referred by their treating physician     for percutaneous locoregional therapies.      Patient's clinical and radiology findings, pathology findings, survival, treatment responses,     and complications after their locoregional therapy will be studied.   "
131533|NCT01563653|"     The investigators hypothesize that an innovative test device simulating transvaginal tape     support will increase the performance and reproducibility of the diagnosis of urethral     hypermobility before surgery for urinary incontinence.      The main objective of this study is to compare two prognostic tests in their ability to     predict the success (or failure) of the implementation of a suburethral TVT (tension-free     vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in     women. The Q-tip test (test mentioned in the French and international recommendations) is     compared to test a new test (clip strip).   "
131534|NCT01563640|"     This is a randomised controlled trial that will be conducted in eastern Thailand in a group     of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms     will be commercially treated to ensure consistent high quality of insecticide impregnation     with permethrin. A double-blind randomised cross-over trial at the school level will cover     two dengue transmission seasons.   "
131535|NCT01563627|"     Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug     resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies     with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where     feasible, surgical removal of the home is the best therapeutic outcome.      Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical     and experimental studies have shown that dysfunction of the blood-brain barrier (BBB)     contributes to epileptogenesis and drug resistance. It is now recognized that cytokines     exacerbate the excitability and permeability of the BBB, which was recently confirmed by     studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have     described an association between pathological angiogenesis and BBB permeability in the tissue     of patients with excision of drug-resistant TLE. With experimental models, it was revealed an     activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.      The investigators hypothesis is that the identification of factors involved in BBB     permeability may designate potential targets for drug-resistant partial epilepsy.   "
131536|NCT01563614|"     The purpose of this trial is to test the safety and tolerance of the combination therapy with     cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from     malignant melanoma.   "
131537|NCT01563601|"     This is a randomized, multi-center, open-label study of approximately 24 months duration     (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in     combination with carboplatin and etoposide versus carboplatin and etoposide alone in     chemotherapy-naive patients with extensive-stage small cell lung cancer.   "
131538|NCT01563588|"     Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them     are able to find back to their initial weight after all treatments are finished. Other     studies have shown that overweight at diagnosis was associated to a twice higher risk of     relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In     western countries, 75% of BCP have insufficient physical activity. Dietary and activity     programs seem to be able to significantly reduce the mortality risk after breast cancer.      The investigators performed a prospective randomized trial consisting in dietary counseling,     physical training and physiotherapy in hydrothermal centers. Intervention were delivered in     small group session lasting 12 days. SPA cares were offered to patients. Patients in the     control group also received dietary counseling given by a dietetician inside anticancer     hospital, and were asked to perform more physical activities. Main endpoints of the trial     addressed quality of life (SF36) one year after inclusion, weight reduction,     anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic     study was associated to the protocol, for volunteers only.   "
131539|NCT01563575|"     The project's background is the notion that patient centred clinical health promotion has     been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO     describes health promotion as a key dimension of quality in hospitals, and the organization     has developed standards on the topic in order to help hospital management and staff members     to assess and improve the quality of health care and thereby achieve better health for     patients, staff, and community. Even so, however, health promotion is still a very implicit     part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments'     health promotion performance is still quite an unexplored area. On this basis, this project     will test a new recognition process that uses the relevant WHO-HPH tools and standards to     assess performance, by way of explicit documentation and evaluation of clinical health     promotion activity. The project is deigned as a RCT, with a control group that undergoes the     recognition process immediately and a control group that continue usual clinical routine.     Then, after one year, the control group also begins the recognition process (= delayed     start), while the Intervention group (=immediate-start) continues with the recognition     process. Doing this allows for a great array of measurements, and hopefully the project will     then show whether the recognition process really benefits implementation of health promotion     in hospitals and health services, and also, if this really generates better health gains for     patients and staff. The outcome measurements will be frequency of health promotion services     delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity     to patients in need. Such services could for instance be motivational counselling and brief     interventions, as well as intervention, rehabilitation and after treatment. Physical, mental,     and social health status among patients and staff will be measured by short form (SF36).   "
131540|NCT01563562|"     The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl     following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and     severe hepatic impairment, as compared to healthy volunteers.   "
131541|NCT01563536|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and     antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir)     administered as two-day monotherapy followed by ABT-267 in combination therapy with other     direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also     known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV)     infection without cirrhosis.   "
131542|NCT01563224|"     There are several developing lines of evidence suggesting that brain receptors called GABA-B     receptors play a significant role in addiction and its treatment. The investigators wish to     examine the sensitivity of brain GABA-B receptors in alcohol and opiate addicts as part of     the investigators MRC programme of research in neurotransmitters in alcohol and opiate     addiction (NOAA). In this present study the investigators will give 2 different single doses     of a drug called baclofen, and a placebo, to 8 healthy male volunteers. This drug affects     GABA-B receptors in the central nervous system and is licensed for the treatment of     spasticity in people with eg spinal injuries; the investigators are interested in its effects     on brain GABA-B receptors. The investigators will measure EEG (brainwaves), eye movements,     blood pressure and heart rate, motor co-ordination and subjective effects and also blood     levels of the drug in the investigators volunteers before and at intervals after dosing. The     investigators will use a double-blind randomised design to minimise expectation effects. The     study will provide information on timing and magnitude of effects of baclofen on brain     function in healthy subjects so that the investigators can optimise selection and timing of     functional measures in future studies of addicts.   "
131554|NCT01563068|"     Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects     with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for     the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a     multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their     primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas     of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14     days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of     calcipotriene will be evaluated   "
133074|NCT01543126|"     Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy     correlate with the prognosis of the disease   "
131543|NCT01563211|"     Patients with breast cancer, who are treated with curative intent, have a combination of     surgery (excision of the tumor) and a course of medical therapy (chemotherapy or endocrine     treatment). Both treatments are associated with significant side effects. Chemotherapy is     associated with nausea, vomiting, hair loss and bone marrow suppression, whereas endocrine     therapy is associated with arthritis and menopausal symptoms. Patients taking either     chemotherapy or endocrine treatment may experience a range of side effects. The range and     severity of side effects experienced vary from patient to patient. Little or nothing is known     about the reason for this difference.      The aim of the investigators proposal is to develop a pretreatment test to identify patients     who are likely to undergo moderate to severe side effects, and therefore help doctors and     patients plan and optimize medical therapy. The pretreatment test will be based on     identifying a metabolic profile which can differentiate those patients who are likely to have     severe or moderate side effects from those with either no or mild side effects. To do this,     the investigators will take urine and blood samples from patients before and after the     administration of endocrine treatment or chemotherapy and generate metabolic profiles.      Furthermore, the investigators aim to gain an understanding into why side effects experienced     between different patients are so variable. To do this the investigators plan to perform     cytokine analysis, targeted genetic analysis and pharmaokinetic analysis on blood sample     collected from patients before and after treatment has commenced. Patients who have planned     surgical excision of tumor and are recommended to receive medical therapy before or after     surgery would be invited to join the study. Each patient will be required to make additional     visits to the hospital to complete questionnaires regarding side effects experienced and for     sample (urine and blood) collection. The investigators plan to recruit 168 patients.   "
131544|NCT01563198|"     Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of     claustrophobia or inability to hold still. Training staff working in MRI facilities to     provide Comfort Talk® promises to enable patients to complete and obtain high quality imaging     without medication, which will increase comfort and reduce sedation risks for the patients,     and increase efficiency and reduce loss of revenue for the facilities.   "
131545|NCT01563185|"     The primary objective of this Phase 4, multi-center, open-label study is to evaluate the     safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10     years to 16 years, 11 months, treated up to 24 weeks.      The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and     to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months     receiving DUEXIS for up to 24 weeks.   "
131546|NCT01563172|"     This study will evaluate and compare the effect of the amount of toothpaste used and brushing     time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel     fluoride uptake (EFU).   "
131547|NCT01563159|"     This study aims to confirm the statistically significant decline in rotavirus related and in     acute gastro-enteritis (AGE) related hospital admissions that was observed in 11     participating hospitals, after the introduction of RV vaccines in Belgium in 2006.   "
131548|NCT01563146|"     This study aims to collect data and assess the number of rotavirus related hospitalizations     in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis     over time.   "
131549|NCT01563133|"     This study focuses on three different lesions: pancreatic cysts, lymph nodes near the     gastrointestinal tract and pancreatic masses.      On one hand, the results obtained during previous studies are more advanced for the     assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser     Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have     already been performed, and an interpretation criteria classification exists. On the other     hand, results for pancreatic masses and Lymph nodes are less developed.      The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on     pancreatic masses and lymph nodes.        1. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and          tissue sampling allows better characterization of pancreatic cysts and improves          appropriate therapeutic decision-making.           For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could          impact patient management by :             -  Ruling out malignancy for patients with benign appearing nCLE images.             -  Characterizing more malignant tumors in the pancreas.        2. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo          imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during          EUS-FNA procedures is feasible and that descriptive criteria can be defined to further          differentiate the different types of lesions.   "
131550|NCT01563120|"     Rationale Gestational diabetes mellitus (GDM) complicates 5-7% of pregnancies. Major hazards     include macrosomia, polyhydramnios, labor trauma and neonatal hypoglycemia. The ADA and ACOG     recommend glucose control in order to reduce the incidence of hyperglycemia induced     complications. Glucose control can be achieved using diet and life style changes. Insulin is     initiated in women who fail to obtain glucose control with diet alone. During the past 11     years oral hypoglycemic drugs have been tested and proven to be efficacious and safe.      Objectives        1. To compare the efficacy and safety of glybenclamide vs. metformin in the treatment of          women diagnosed with GDM        2. To evaluate the improvement in glycemic control after the addition of a second oral          hypoglycemic drug after failure of the first      Hypothesis GDM is one of the major conditions contributing to obstetrical complications and     prenatal morbidity. Improving glycemic control, by means of improving compliance and patient     satisfaction, will decrease obstetrical complications, maternal and neonatal morbidity and     have positive long term health implications.      Study design Prospective, randomized, open label      Study population Women between the ages 18-45, diagnosed with GDM will be recruited. GDM will     be defined by a pathological OGTT (according to Carpenter and Coustan criteria) performed at     or after 13 weeks of gestation.      Study period From recruitment until discharge of the newborn baby after delivery      Study protocol Women will be randomized at recruitment. Demographic and obstetrical data will     be collected. Average glucose levels during the previous two weeks, estimated fetal weight     and amniotic fluid index, and lab exams reflecting glycemic control will be noted. Women will     provide daily glucose levels via fax or mail once a week. Glycemic control will be evaluated     by a daily chart, including 7 measurements: 3 preprandial, 3 postprandial and a 7th     measurement at 10 pm. Women will be invited to a monthly follow-up, which will include a     sonographic evaluation of fetal weight and amniotic fluid, and lab exams. Follow-up protocol     after 38 w of gestation will be according to our ward's protocol. The study was approved by     the local Helsinki committee.      Time table Duration: two years   "
131551|NCT01563107|"     Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma     volume in response to a high sodium diet. Mechanisms involved in the regulation of plasma     volume, such as the renin-angiotensin-aldosterone system and renal dopamine (DA), may be     impaired in POTS and may respond inappropriately to changes in dietary sodium. The     investigators propose that the changes in urinary sodium and dopamine excretion caused by     consuming low-sodium and high-sodium diets will be different between patients with POTS and     healthy volunteers. The purpose of this study is to determine (1) whether changes in dietary     sodium level appropriately influence sodium excretion in POTS; (2) whether changes in dietary     sodium level appropriately influence DA excretion in POTS; (3) whether a high dietary sodium     level appropriately expands plasma volume in POTS; and (4) whether patients with POTS have     improvements in their orthostatic tachycardia and symptoms as a result of a high dietary     sodium level.   "
131552|NCT01563094|"     This is a prospective observational trial of healthy postpartum women to investigate changes     in bone density and markers of bone turnover during lactation. The study hypothesis is that     women who breast-feed 5 months or more will lose bone density and subsequently regain the     bone density after weaning. This study seeks to define determinants of the regain in bone     density.   "
131557|NCT01563029|"     This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy,     parallel-group, placebo and active controlled study in children aged 5-11 years with     persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of     the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period     during which time they will continue their current medications. Visit 2 will occur two weeks     into the run-in period to allow a review of compliance with daily diary and run-in     medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility     criteria who remain uncontrolled despite baseline therapy will be stratified based on pre     screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to     the treatment phase of the study where they will receive one of five treatments for 12 weeks.     Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of     115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits     at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be     performed one week after completing study medication. All subjects must attempt spirometry     measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for     urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2     and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and     7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF     from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean     over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal     examinations, clinical chemistry, urinary cortisol, and vital signs.   "
131558|NCT01563016|"     The research aims to investigate the relationship between self-control ability and blood     glucose level in schizophrenic patients. The main purpose of the present study is to explore     whether the close relationship of blood glucose and self-regulatory strength observed in     healthy individuals, is applicable to schizophrenic patients. More specifically, the current     study aims        -  to investigate whether the exertion of self-control reduces blood glucose,        -  to examine whether low level of blood glucose deteriorates subsequent self-control          performances        -  to examine whether restoring the glucose level eliminates these impairments, in          schizophrenic patients.   "
131559|NCT01563003|"     Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this     study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in     50 adolescents versus other available treatment options.   "
131560|NCT01562990|"     The purpose of this study is to determine the recommended dose of CMC544 administered in     combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and     oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of     this combination will be evaluated preliminarily in patients with DLBCL in relapse or     refractory, who are no candidates for autologous transplant.   "
131561|NCT01562977|"     The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and     dexametasone (R-GemOx) chemotherapy schedule.   "
131562|NCT01562964|"     This study will investigate whether clinical hypnotherapy can effectively treat chest pain     symptoms, improve emotional wellbeing and quality of life in postmenopausal women with chest     pain and coronary arteries without any narrowings. The diagnosis of chest pain with 'normal'     coronary arteries is found in 25% of patients undergoing investigation of chest pain using     coronary angiography (when dye is injected into the coronary arteries whilst xray pictures     are taken), and the majority of these patients are postmenopausal women. Often there is no     obvious physical cause. Despite symptoms being treated using conventional drugs, and life     expectancy is not affected, many patients continue to suffer from debilitating chest pain     symptoms, frequently resulting in visits to hospital, increased psychological illness and     poor quality of life. The investigators are interested in finding ways of improving not only     chest pain symptoms but also psychological wellbeing and quality of life in these patients.     Previous studies of ours have found improvement in these patients after taking part in a     support group, and using a relaxation technique called Autogenic training. Recently the     investigators conducted a pilot study which showed a favourable effect of hypnotherapy on     physical ability, well-being and quality of life. The investigators would now like to extend     this study, performing a larger randomised, controlled trial. The investigators hypothesise     that hypnotherapy will beneficially affect symptoms and quality of life in patients with     cardiac Syndrome X.   "
131563|NCT01562951|"     This study will test that individualized treatment in patients with Crohn's Disease in     remission or mild clinical activity under immunosuppressants may improve prognosis, rather     than just treating flares.   "
131564|NCT01562938|"     This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects     (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or     placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed     for safety from the time of Informed Consent through 360 days post dose.   "
131565|NCT01562925|"     Patients with impaired renal function are at elevated risk for development of contrast-medium     induced acute kidney injury (CI-AKI). CI-AKI is associated with increased risk for     cardiovascular morbidity and mortality. Effective CI-AKI prevention strategies are needed.      The RenPro-II-WINE Trial was designed to test the hypothesis whether moderate red wine     consumption prior to contrast-medium use is effective in CI-AKI prevention.      Consecutive patients with impaired renal function undergoing elective coronary angiography     will be assigned in one of four treatment arms: a. control patients receiving standard care     b. patients receiving standard care plus red wine c. patients receiving standard care plus     white wine d. patients receiving standard care plus beer This study will give important     answers on how to prevent CI-AKI in patients with impaired renal function undergoing contrast     media exposure.   "
131579|NCT01562743|"     The aims of the trial are to assess the safety and the efficacy of SPM 962 following     once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese     patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum     treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week,     double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003).     The trial is also for an exploratory investigation of incidence of augmentation, the most     problematic complications in dopaminergic treatment.   "
131580|NCT01562730|"     Study evaluates the new technique MyoVista™ iECG sensitivity and ability to predict     myocardial diseases, comparing iECG results with Computed Tomography Coronary Angiography     findings   "
131581|NCT01562717|"     The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients     with ankle injuries.   "
131627|NCT01562119|"     The present study was to retrospectively evaluate the long-term outcomes of the cograft     acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of     functional regional wounds in burned patients.   "
131566|NCT01562912|"     Atrial fibrillation (AF) is the most common arrhythmia affecting the Canadian population. AF     is associated with increased risk of stroke,HF, and even mortality. AF can cause debilitating     symptoms, adversely affect patient's (pt's) quality of life and functional status. Hence a     strategy of sinus rhythm (SR) may be pursued over a strategy of allowing AF to persist.     Percutaneous catheter ablation is an effective alternative to antiarrhythmic drugs (AAD) for     maintaining SR. The success rate of PV isolation off AAD is about 80-90% in pt's with PAF,     but repeat procedures are required in up to 40% of pt's. After one ablation, the success rate     may only be 50-70% off drugs.Current standard ablation procedures for PV antral isolation     employ mapping systems which reconstructions of the LA and PV anatomy are created.     Visualization may be supplemented by integration of CT/ MRI images and/or intracardiac     echocardiography. Robotic navigation has been employed to assist in ablation. Based on single     point unipolar radiofrequency (RF) ablation catheter where lesions are created point-by-point     around the PVs to obtain electrical isolation.This results in lengthy complex, costly     procedures,often more than 4 hours, which requires high degree of operator skill.Creation of     contiguous, transmural lesions is challenging with standard single-point RF. A novel     multipolar catheter ablation system has been evaluated for achieving PV isolation (PVAC     catheter, Medtronic Inc.) An over-the-wire circular mapping/ablation catheter can be advanced     into the PV antrum, and multiple lesions around the circumference of the catheter can be     delivered simultaneously using duty-cycled unipolar and bipolar RF energy. Early reports, the     system can achieve complete PV isolation with reduced fluoroscopy and procedural times using     lower powers to achieve more reliable lesion sets.Long-term efficacy also seems comparable to     standard RF ablation.This novel technology has potential to broaden the application of AF     ablation, making procedures less time-consuming, less complex without compromising procedural     efficacy. Published data PVAC technology outcomes are limited to studies with small sample     sizes of 12-102 pt's. Data has been restricted to a small number of European centers     performing moderate numbers of PVAC procedures. There is no prospective, multicenter data.     Little is known about the efficiency of PVAC procedures, allowing for an assessment of     cost-effectiveness in using this technology.   "
131567|NCT01562899|"     This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is     to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the     combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the     clinical efficacy and to further assess the safety of the combination in selected patient     populations. The dose escalation part of the study will be guided by a Bayesian Logistic     Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose     escalation part.      Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess     efficacy of the combination as well as to better understand the safety, tolerability, PK,     antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of     approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will     consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm     3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.      Patients will be treated until progression of disease, unacceptable toxicity develops, or     withdrawal of informed consent, whichever occurs first. All patients will be followed up - at     minimum patients must complete the safety follow-up assessments 30 days after the last dose     of the study treatment.   "
131568|NCT01562886|"     This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral     therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of     the study the participants will attend clinic where they will have blood collected followed     by a lumbar puncture where cerebrospinal fluid will be collected to measure drug     concentration. The participants will then restart their original regime with nevirapine.   "
131569|NCT01562873|"     Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is     thought that this pathway might be important in certain types of breast cancer, and that     blocking this pathway might lead to anti-cancer effects. This study is testing the effects of     ruxolitinib in patients with breast cancer.   "
131570|NCT01562860|"     The investigators are comparing two standard of care procedures which can be performed at the     same time, or sequentially. The hypothesis being tested is whether simultaneous release of     both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom     relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal     tunnel and pronator Teres syndromes are present.   "
131571|NCT01562847|"     The purposes of this study are to investigate expression and frequency of ABL point     mutations, a major cause of resistance in imatinib failed CML Asian patients and to find     causes of Asian-specific resistance to cancer-targeting therapies through a prospective     investigation of dynamics of point mutations and expression of new point mutations during     nilotinib treatment.   "
131572|NCT01562834|"     This trial is conducted in Europe. The aim of this trial is to assess the effect of     somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients     with a growth hormone deficiency.   "
131573|NCT01562821|"     This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic     efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo     partial hepatectomy due to liver cancer or benign tumours.   "
131574|NCT01562808|"     Dopamine receptor occupancy and brain metabolism were measured using positron emission     tomography after the administration of aripiprazole. Working memory performance was also     measured using N-back task.      The investigators explored the relationship between changes in brain metabolism and working     memory performance.   "
131575|NCT01562795|"     This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have     therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two     nonsteroid anti-inflammatory drops with topical corticosteroids.   "
131576|NCT01562782|"     The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in     response to the ingestion of a mixture of glucose and fructose is greater in South Asians     compared to controls (Caucasians).   "
131577|NCT01562769|"     Application of isolation (=contact precautions) in hospitalized patients is recommended when     patient is colonized (or infected) by micro-organism known for its outbreak capacity or high     pathogenicity. It allows the reinforcement of universal precautions (=standard precautions)     in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy     of this measure is questioned and its impact on patient care seems deleterious.      In a particular context of Infectious Disease Unit, where standard precautions are handled     (favorable architecture and appropriate practice for hand hygiene), assessment of contact     precautions to reduce the incidence of acquired bacteria during hospitalization would be of     interest.      The investigators design a non-inferiority comparative study to measure the colonization     pressure in patients hospitalized in two different parts of the department: one unit only     with standard precautions applied (intervention) and one unit with contact precautions     (control) as current routine care.   "
131584|NCT01562678|"     The main purpose of this study is to help us understand the effects of diabetes medication     Liraglutide on weight loss and hunger. The investigators have already determined what the     highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide     was approved by the FDA in January 2010 for treatment of diabetes.      The investigators will also study the following:        1. The impact of Liraglutide on brain responses to food        2. It's effect on physiological and mental performance        3. If its effect on the brain differs among obese and lean diabetic subjects.   "
131585|NCT01562665|"     The overall aim of the study is:      To provide accurate and reliable information regarding NSCLC clinical management across MENA     region in order to detect unmet medical needs of this disease in terms of:        -  Patient and hospital characteristics.        -  Diagnostic and treatment approaches: initial and subsequent.        -  Follow-up patterns in clinical management.        -  Outcomes: symptoms, death, functionality, quality of life.        -  Use of resources and burden on patients and health care systems.   "
131586|NCT01562652|"     Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated     that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of     the disease are pain and functional disability.      This study has two aims:        1. To characterise the gait patterns and clinical parameters of patients with knee          osteoarthritis (KOA) in Singapore at baseline, prior to treatment.        2. To investigate the changes in gait patterns and the clinical benefits of treatment with          a new biomechanical device, AposTherapy, for patients with KOA.   "
131587|NCT01562639|"     The purpose of this study is to collect following data in patients given Nexium capsule     (Nexium) in usual post-marketing use as the maintenance therapy for repeatedly     recurring/relapsing reflux oesophagitis.   "
131588|NCT01562626|"     The purpose of this study is to test the safety and efficacy of an investigational drug     called APS001F when given with flucytosine (5-FC) for treatment of solid tumors. APS001F is a     recombinant Bifidobacterium longum (a live bacteria normally found in the digestive tract)     that has been modified to produce an enzyme, cytosine deaminase (CD). The patient will first     receive an injection of APS001F followed by oral 5-FC. APS001F is expected to go to the site     of the tumor(s) where the agent will produce CD enzyme. CD enzyme will convert the 5-FC into     5-fluorouracil (5-FU) which is a standard chemotherapy drug for several types of cancer.     Additionally, some patients will also receive 10% maltose injection, a sugar that has been     shown to enhance the growth and effectiveness of APS001F in animals. This is the first study     where APS001F is being used in humans.   "
131589|NCT01562613|"     The primary objective of the study is to evaluate the proportion of hypertensive patients who     achieve regulation of their blood pressure (BP) levels according to the European Society of     Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with     eprosartan for 6 months under standard medical practice conditions. The absolute change in     Systolic blood pressure from baseline will also be calculated.      This study also aims in the evaluation of Framingham stroke risk profile score of patients     treated with eprosartan under standard clinical practice conditions during the observation     period. Besides the primary and the secondary objective of the study, the assessment of the     percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs),     Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per     observed event) and the percentage of patients who discontinued treatment prematurely before     the advent of the 6-month observation period due to toxicity to the study medication     constitutes another important objective that is related to the safety of the treatment.   "
131590|NCT01562600|"     The purpose of this investigation is to collect following data in patients given Nexium     capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of     gastric ulcer or duodenal ulcer with non-steroidal anti-inflammatory drug (NSAID).   "
131591|NCT01562587|"     This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics     of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a     non-bleeding state.   "
131592|NCT01562574|"     This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of     activated recombinant human factor VII and standard treatment compared with standard     haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric     congenital heart disease.   "
131593|NCT01562561|"     This trial is conducted in Asia and South Africa. The aim of this trial is to compare the     efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with     insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.   "
131594|NCT01562548|"     Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to     investigate the evidence that guaifenesin is an effective treatment for upper     back/neck/shoulder muscle spasm/stiffness and pain.   "
131595|NCT01562535|"     Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It     is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a     parent tries to pull the child by the arm and a clic or clunk is felt with immediate pain     and unwilling to move the arm. It is not a dangerous condition although it is distressing for     kids and their parents/caretakers.   "
131596|NCT01562522|"     The purpose of the protocol, is to assess the feasibility of conducting a larger trial to     evaluate the effect of a psychological intervention on the well-being of patients on     luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and     their partners.   "
131597|NCT01562509|"     The main objective of the proposed study is to assess the effectiveness, feasibility and     costs of a tailored strategy (developed in accordance with the barriers found and current     practice) to improve care for patients with non-Hodgkin's lymphomas (NHL), compared to a     common strategy of 'audit & feedback'.   "
131598|NCT01562496|"     The primary goal of this study is to determine the neuroprotective qualities of long-term, in     home, exercise therapy program in human PD patients. It is hypothesized that an exercise     intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection).     The first part involves a pilot-study in which the feasibility of the intervention and     outcome measures will be tested.   "
131628|NCT01562106|"     The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence     imaging in endometrial cancer staging by sentinel node assessment.   "
131599|NCT01562483|"     Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain     can persist for months or even years and significantly diminishes quality of life. The exact     underlying cause for this pain persistence is still unclear, which makes its treatment still     a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the     improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the     basis of the present research proposal.      The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic     during a long-term treatment (52 days) of persistent postsurgical abdominal pain.   "
131600|NCT01562470|"     Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo.      This will be a double-blind, placebo-controlled study involving subjects with distinctive     cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo     to the other, by random allocation, and cellulite appearance will be measured at week 0, 8     and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher,     who will assess cellulite appearance on a precisely-measured upper leg area. The subjects'     own perception of cellulite appearance, from their diaries, will be numerically coded, and     all three measures will be collated and analysed statistically.   "
131601|NCT01562457|"     This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the     intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two     administrations of activated recombinant human factor VII in haemophilia patients in a non     bleeding state.      The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a     (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM®     parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot     Firmness) and LI60 (Lysis index 60 min after CT).   "
131602|NCT01562444|"     The aim of this study is to investigate the immunogenicity response in adults up to 10 years     after one booster dose. Data collected from this study will allow for greater information to     prescribers who administer TBE vaccine, so that they can appropriately time the     administration of booster vaccinations to individuals who received different vaccination     schedules and who live in tick borne encephalitis endemic regions.   "
131603|NCT01562431|"     Background      An important part of individuals undergoing genetic counseling and/or testing for cancer     experience psychosocial problems and worries during or after this process. Approximately 20%     of these individuals experience serious problems, such as fear for cancer in themselves or     their relatives, family communication problems, unresolved grief, problems in coping with the     DNA-test-results, difficulties in choices with regard to DNA-testing, preventive surgeries,     and concerns about insurance or work. Research shows that these problems are frequently     undetected by the counselors. Within the limited available time of a counseling session, a     lot of information should be given to the counselee. This information is mostly biomedical     and provider driven. Therefore psychosocial issues can be underexposed. The use of a brief     questionnaire, completed by the counselee prior to the counseling session, can serve as a     tool for the counselor to screen and address the relevant psychosocial issues in a systematic     manner. Therefore, in 2009-2010 the investigators have developed and validated the     'Signal-checklist' to identify relevant psychosocial problems frequently encountered in the     cancer-genetics setting, and need for extra psychosocial services. This 'Signal-checklist'     can serve as a tool in screening systematically for psychosocial issues, addressing these     issues and directing appropriate referrals to extra psychosocial services. The Signal-Trial     will be performed to evaluate the use and effectiveness of the checklist.      Aim      The aim of the trial is to evaluate the implementation of a short, self-developed     cancer-genetics checklist; the 'Signal-checklist', as an aid in 1) facilitating communication     on psychosocial issues during the genetic counseling session, 2) increasing counselors     awareness of psychosocial problems of the counselee, and 3) improving the management of these     psychosocial problems during and after the process of genetic counselling.      Method      This study is a collaboration between the family cancer clinics of the NKI-AVL and the UMCU.     Individuals requesting genetic counseling for the high incidence of cancer in their family     are invited to participate in the trial. Participants will be asked to complete the 'Signal     checklist' prior to their counseling visit. Participants (N=264) will be randomly assigned to     one of the two study arms. The intervention group will receive feed-back on the     'Signal-checklist', whereas the control group will not receive feed-back. Three weeks after     the DNA-test disclosure session, participants will be asked to complete again the     'Signal-checklist' followed by a telephone call by their counselor. Again, the results of the     'Signal-checklist' will be available to the counselor for participants in the intervention     group, but not for the control group. Both the genetic counseling session and telephone call     will be audio taped. Furthermore, all participants will be asked to complete three     questionnaires on the Internet (or by mail, if preferred); 1) before randomization (3 weeks     prior to the counseling session), 2) three weeks after the counseling session, and 3) four     months after the potential DNA-test result disclosure. These questionnaires include items on     communication during genetic counseling, the need for professional psychosocial support,     cancer worries, satisfaction with received care, and experiences with the use of the     'Signal-checklist'. The audio-tapes and completed questionnaires will be used to measure     psychosocial problems of the counselees, the awareness of the counselors of these problems,     and the management of these problems. Secondary analysis will be conducted to assess the need     for extra psychosocial services, satisfaction with genetic counseling, feasibility of     implementing the 'Signal-checklist' and decreasing psychosocial problems over time.   "
131604|NCT01562418|"     Computer settings points to a number of risk factors which may induce the development of Work     related MSD (WRMSD). In light of the expanded use of computers and the increased occurrence     of Upper Extremity (UE) WRMSD among computer operators various intervention programs have     been developed and tested. Nevertheless, many of these programs do not meet the criteria of     quality and level of evidence.      The main objective of this study is to use simultaneously a three dimensional (3D) kinematic     analysis system, surface electromyography (SEMG) and fingertip force measurement system     (Flexiforce) while typing, to test the efficacy of primary and secondary preventive     intervention programs aimed at reducing MSD among computer operators.      Work hypothesis: Significant score differences will be found on the evaluation parameters     between the research group which underwent ergonomic training with biofeedback, the group     without feedback, and the control group.The evaluated parameters will correlate with the     appearance of MSD symptoms and pain and will affect level of function.      The study will include 66 participants, programmers and computer engineers. The participants     will be assigned randomly to one of three groups: 1) participants will receive ergonomic     training with biofeedback; 2) participants will receive ergonomic training without     biofeedback; and 3) control group, without intervention. Each group will consist of 22     participants.      Treatment efficacy will be tested both at work and in the motion lab. In the lab, 3D     kinematic measurements and fingertip forces relevant to typing while entering a standard text     will be measured. At the work site, anthropometric and measurements, work station     measurements, posture observation and questionnaires about, psychosocial status, function and     pain level will be filled The preventive program will be performed at the workstation after     the preliminary data collection phase. The program will consist of one group meeting at the     workplace for all employees participating in the study, and individual instruction at the     workstation, including 3-6 meetings for the two research groups. Data will be collected     before and after the intervention program.   "
131605|NCT01562405|"     It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or     prevent the growth of cancer cells along with improving anemia and bone lesions that     sometimes occur in people with multiple myeloma.      This current study is the first study combining ACE 011 with lenalidomide. In this research     study, the investigators are looking for the highest dose of ACE 011 that can be given with     lenalidomide and dexamethasone. The investigators will also begin to collect information     about the effect of the combination of ACE 011, lenalidomide and dexamethasone on multiple     myeloma.   "
131606|NCT01562392|"     The purpose of the study is to study the potential anti-inflammatory- and metabolic effects     of polyphenols and dietary fibres in a product based on a mixture of several Swedish berries     and vegetables that is known to have high amounts of polyphenols and other anit-oxidants. In     addition the purpose is to investigate the effects on cognitive functions of the berry     product.   "
131607|NCT01562379|"     The purpose of this study is to test the impact on child growth of three specially formulated     complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available     complementary food, and vs. a control group that receives no food. All groups will receive     nutrition education related to infant and young child feeding. This will be a     cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in     Bangladesh.   "
131608|NCT01562366|"     Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater     Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a difference     between the two treatment groups.   "
131609|NCT01562353|"     This is a clinical study on patients who have been prescribed opioids (narcotic pain     relievers) for the treatment of pain, to determine what genetic factors influence outcome of     treatment. Procedures include: an initial telephone prescreening, completion of a number of     questionnaires, and a blood draw to determine genetic factors. Participants will take part in     a one-time clinic visit, during which all procedures will be completed.      The investigators hypothesize that several classes of genes, including genes in opioid, pain,     and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed     nondependent subjects.   "
131610|NCT01562340|"     In this study, the investigators will administer pomegranate juice or fruit extract as a     targeted antioxidant therapy to hemodialysis patients.      The investigators will examine whether these pomegranate products will be safe and     well-tolerated. The investigators will also examine whether these products may lead to     improvements in blood serum biomarkers of:        -  oxidative stress status        -  inflammatory status        -  endothelial dysfunction   "
131629|NCT01562093|"     In this study we will investigate the effect of intranasal corticosteroid therapy, which is     known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.   "
131612|NCT01562314|"     Ulcerative Colitis is an inflammatory bowel disease (IBD) effecting large amounts of the     population. The most common treatment for this condition is 5-aminosalicylic acid (5-ASA),     however patients failing to respond to this and incurring a flare up are often escalated to     steroidal treatments.      This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the     efficacy and safety of GWP42003 (0mg - 250mg twice daily), compared with placebo, by the     percentage of participants achieving remission quantified as a Mayo score of 2 or less (with     no subscore > 1) after 10 weeks treatment.      This is the first study to determine whether the study medication has a positive benefit for     subjects on their ulcerative colitis symptom control, as well as effects on inflammatory     marker cytokines (plasma tumour necrosis factor [TNF]α, interleukin [IL]-2, IL-6), C reactive     protein [CRP], faecal inflammatory marker (calprotectin), stool frequency (NRS), rectal     bleeding (NRS), pain (NRS). In addition, various IBD questionnaires are being implemented in     the study to observe further benefits on the study medication, compared with placebo.      This study will be a multi-centre, randomised, double-blind, placebo-controlled,     parallel-group pilot study. There will be two parallel groups of participants (0mg-250mg     GWP42003 and placebo, twice daily), with a treatment duration of 10 weeks as well as a 7 day     baseline period and one week follow-up. The two treatment groups of 0mg-250mg GWP42003 and     placebo will be randomised equally into a 1:1 ratio, with 31 participants in the active IMP     group and 31 participants allocated placebo treatment.      In order to be eligible for enrollment in this study, subjects will need to be aged 18 years     and above (18-65 for Czech Republic) and be clinically diagnosed with with mild or moderate     ulcerative colitis and on a fixed dose of 5-ASA treatment (0 mg dose of 5-ASA is acceptable)     and have been on a stable dose for at least 2 weeks prior to screening.      Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline     period. Each subject will have a Mayo (including endoscopy) assessment conducted to confirm     eligibility. If eligible, the subject will be randomised into the 10-week treatment phase.     There are a total of 6 visits in the study.   "
131613|NCT01562301|"     The goal of this clinical research study is to find the highest tolerable dose of Anvirzel     (Nerium Oleander) that can be given to lung cancer patients receiving standard therapy with     carboplatin and docetaxel. Researchers also want to learn what effect Nerium Oleander may     have in combination with carboplatin and docetaxel.   "
131614|NCT01562288|"     RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received     chemotherapy with or without trastuzumab may help doctors learn more about the effects of     trastuzumab on cells. It may also help doctors understand how well patients respond to     treatment.      PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer     treated with chemotherapy with or without trastuzumab.   "
131615|NCT01562275|"     This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety,     tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in     combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients     will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study     treatment is until disease progression or unacceptable toxicity occurs.   "
131616|NCT01562262|"     Not all patients with the Obstructive Sleep Apnea Syndrome (OSAS), mostly mild, have     excessive daytime sleepiness. Sleep fragmentation provides the performance decrease with     increasing reaction time to external stimuli and correlates with excessive sleepiness. So,     the study aims at assessing the effect of sleep fragmentation on the Reaction Time and it`s     maintenance in patients with OSAS compared with healthy, to better clarify were patients with     and without somnolence differ. For that, will be recruited 30 male volunteers aged between 20     and 50 year old to participate in the study. They will be distributed in three groups:     CONTROL (without symptoms of sleepiness and apnea and hypopnea index (AHI) less than 5),     SS (with AHI between 5 and 15 without symptoms of somnolence) and group CS (with AHI     between 5 and 15 with symptoms of somnolence). The groups will undergo a polysomnography and     subsequently, the Test and Maintenance of Wakefulness and PVT Battery Tests. The reaction     time will be compared, as well as the ability to keep the reaction time over time between     groups to see whether there is a difference between the motor performance throughout the day     and the perception of sleepiness.   "
131617|NCT01562249|"     The purpose of this study is to verify the effectiveness of a systematic rehabilitative     program for mastication in patients submitted to orthognathic surgery.   "
131618|NCT01562236|"     Background and objectives: Male sex is a risk factor for poor neurodevelopmental outcome     following preterm birth. The investigators aimed to investigate gender-related differences in     amplitude-integrated electroencephalography (aEEG) and to correlate these findings with     neurodevelopmental outcome.      Methods: Preterm infants born <30 weeks' gestational age between 2000 and 2002 were     prospectively included. aEEGs obtained within the first two weeks of life were evaluated and     classified according to background activity, sleep-wake cycling (SWC) and seizure activity.     Outcome was assessed at three years.   "
131619|NCT01562223|"     RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance     imaging or DCE-MRI and diffusion-weighted imaging or DWI, may provide images of prostate     cancer or any cancer that remains after biopsy.      PURPOSE: This trial studies repeated DCE-MRI and DWI in patients diagnosed with prostate     cancer.   "
131620|NCT01562210|"     Phase I dose escalating trial. Primary objective of this study is to define the maximal     tolerated dose (MTD)of Olaparib in combination with high dose radiotherapy with or without     daily dose Cisplatin in locally advanced NSCLC. Secondary objectives include to define safety     profile, determine PK/Pd variables and document preliminary evidence of objective tumor     response.   "
131621|NCT01562197|"     This clinical trial will recruit patients diagnosed with glioblastoma at the time of     recurrence or progression following prior treatment with surgery, radiation therapy and     alkylating chemotherapy. Patients will be screened and if found eligible will be randomized     to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib     treatment-arm will be treated with Axitinib until progression (they can be treated after     progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or     patients refusal to continue study treatment. Patients randomized to the Axitinib plus     Lomustine-arm will receive treatment until progression, unacceptable treatment related     toxicity, or patients refusal to continue study treatment.   "
131622|NCT01562184|"     Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression     that has shown promising efficacy in four recent double-blind, randomized, sham-controlled     trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing     its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and     biomarkers will be measured during the trial.   "
131623|NCT01562171|"     Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks     will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with     high cholesterol and obesity.   "
131631|NCT01562067|"     Cervical tumors are characterized by vascular changes (in terms of quantity, volume and     Flows) in the tumor. Due to a good access to the cervix through the vagina, these parameters     can be assessed using a three dimensional supersonic. Sonographic characteristics of tumor     indices measures before and after oncological treatments may shed light on the patient's     prognosis.   "
131632|NCT01562054|"     The operating room, OR, is a high-tech and complex domain in which clinicians' possession of     clinical knowledge and good technical skills are essential, but not sufficient. Retrospective     studies have shown that a large proportion of the mistakes that occur during surgery are not     caused by lack of clinical skills but rather by insufficient communication and teamwork.     Prospective studies have shown that insufficient teamwork in the OR causes a higher risk of     complications and that communication failure in the surgical team causes procedural errors     and delays. It is therefore evident, that surgeons and the surgical teams need skills in     communication, teamwork, decision making and leadership (so called non-technical skills) to     ensure a good outcome for surgical patients.      Internationally different behavioural marker systems have been developed to aid training and     assessment of non-technical skills such as Non-Technical Skills for Surgeons (NOTSS) from     Scotland (12). In Denmark certain aspects of non-technical skills appear in the curricula for     surgical trainees, but no formal training or assessment occurs at this point.      The investigators developed a behavioural marker system for general surgeons adapted to the     Danish cultural and organisational context (NOTSSdk). The behavioural marker system consists     of four categories: leadership, situation awareness, decision making and communication &     teamwork. Each category has between 3 and 4 elements underpinning it and each element has     several behavioural examples illustrating good and poor behaviour.      The system needs evaluation to ensure that it is valid and can be used reliably to observe     and rate surgeons' intra operative performance.      Aim: The aim of this study is to examine the psychometric properties of NOTSSdk in relation     to it's construct validity, reliability, and usability in a simulated setting.      Research questions:        -  What is the inter rater reliability among raters?        -  Are these ratings consistent with expert ratings (= gold standard ratings)?        -  Can a one day training session improve novice raters' agreements (construct validity)?      METHODS The study is designed to explore the reliability of the ratings made by surgeons as     well as to examine whether the reliability improves with training. The study setting will be     a one day course in which surgeons are asked to rate the non-technical performance of     surgeons in simulated video scenarios. Two distinct sets of ratings will be obtained. The     first at the beginning of the day when the surgeons have had no prior training in or     knowledge of rating non-technical skills and at the end of the day after 5 hours of training.      Sample A sample of general surgeons from all hospitals in Zeeland, Denmark will be recruited     to participate as raters after the heads of the departments have been contacted and informed     about the project. The investigators wish to recruit consultant surgeons (n=10) and senior     residents in surgery (n=10) who have an interest in education and supervision. Once recruited     background information such as age, gender, position, years of surgical experience and prior     experience with assessment of others will be collected.      Training and rating session The surgeons will attend a one day course. The course will     consist of three parts: first a rating session to get baseline-ratings from participants of 6     video scenarios, then a teaching and training session and then another rating session with 4     new and 2 of the baseline-videos. During the first rating session the surgeons will only have     the NOTSSdk rating form and will not be allowed to discuss with each other. The second rating     session will be like the first but in addition to the rating form the participants will also     be allowed to look in the full NOTSSdk behavioral marker system. The teaching will include an     introduction to Human Factors and non-technical skills in surgery, and a short description of     the development and intended use of NOTSSdk. The following training will allow participants     to practice the rating of surgeons' non-technical skills on 4 video recorded scenarios and     then discuss their ratings.      Ratings of the lead surgeons' performance will be obtained at the category level of each     scenario.      Video recordings 14 simulated video recordings will be made showing general surgeons acting     in their own roles during surgery. The scenarios will be scripted to display various     scenarios of routine (such as unnoticed prolongation of a laparoscopic appendectomy) and     non-routine situations (such as unexpected bleeding during open surgery). The scenarios will     be designed after a specific structure aiming at a specific variation in the surgeons'     non-technical performance according to the four categories of NOTSSdk.   "
131633|NCT01562041|"     The study is designed to evaluate the use of ETT ECG indices as biomarkers in the assessment     of atherosclerotic coronary vascular disease (ASCVD).   "
131634|NCT01562028|"     Rationale:      Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor     receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival     between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations     can only imperfectly predict outcome. The investigators hypothesize that progression-free     survival could be influenced both by the pretreatment EGFR T790M mutation and by components     of DNA repair pathways.      The investigators propose a model of treatment whereby patients with EGFR mutations (single     or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus     bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is     that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups.   "
131635|NCT01562015|"     Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior     therapies. The study will take place globally at multiple study centers. Subjects will be     enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and     will repeat this schedule until the cancer gets worse or the subject is unable to tolerate     ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how     active it is in ALK positive NSCLC.   "
131636|NCT01562002|"     The purpose of the study is to determine whether allogenic bone marrow stem cell transplant     is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic     limbus stem cell transplant.   "
131637|NCT01561989|"     This randomized clinical trial studies cholecalciferol and flu vaccine in treating healthy     participants. Cholecalciferol may increase the immunologic response of flu vaccine in healthy     participants. Flu vaccine may help the body build an immune response and help prevent flu   "
131638|NCT01561976|"     Metformin hydrochloride in its immediate release (IR) form has been successfully used for     decades in the treatment of type 2 diabetes; however the IR formulation may be associated     with gastrointestinal side effects (especially nausea, diarrhea) in 20-30% patients, which     can limit the tolerated dose, reduce adherence and result in discontinuation of therapy.     Metformin hydrochloride extended release formulations have been developed to overcome these     problems. In India, extended release formulations of metformin hydrochloride include     metformin SR 1000mg tablet and combination of metformin hydrochloride SR 1000mg/glimepiride     2mg tablet. In the combination tablet, only metformin hydrochloride is in the extended     release form. In view of the fact that extended release metformin hydrochloride is usually     recommended with a meal, that food is known to affect the pharmacokinetic (PK) parameters of     metformin and that there is a potential for dose dumping with extended release formulations     that may lead to side effects similar to IR formulations, a study to estimate the magnitude     of the food effect for these formulations in fed state compared to the fasting state is     warranted. This study will be a randomized, single-center, open-label, single-dose,     three-period, 6 sequence crossover study in 30 healthy adult volunteers to estimate the     bioavailability of metformin from metformin hydrochloride 1000mg SR tablet given in fasting     condition relative to metformin hydrochloride 1000mg SR tablet and a fixed dose combination     of metformin hydrochloride 1000mg SR /glimepiride 2mg tablet, each given in fed condition.     The safety and tolerability profile of metformin SR 1000mg tablet and metformin hydrochloride     SR 1000mg/glimepiride 2mg tablet will also be evaluated in this study. The primary PK     endpoints will be Cmax and AUC (0-∞). The secondary PK endpoints will include AUC (0-t), Tmax     , T lag, Kel and t1/2. Safety endpoints will include vital signs, ECG, physical examination,     clinical laboratory tests and adverse event reporting.   "
131639|NCT01561963|"     The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be     affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.   "
131640|NCT01561950|"     This trial is conducted in the United States of the America (USA). The aim of this trial is     to evaluate the effectiveness of activated recombinant human factor VII to mitigate     experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).   "
131641|NCT01561937|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     evaluate the efficacy of activated recombinant human factor VII to mitigate     experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a     targeted INR (International Normalization Ratio).   "
131642|NCT01561924|"     This trial is conducted in Europe and the United States of America (USA). The aim of this     trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM®     (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in     a non-bleeding state.   "
131643|NCT01561911|"     The Purpose of this study is to evaluate the safety and tolerability, and the biological     effects of the chimeric anti-CD40 monoclonal antibody Chi Lob 7/4, given intravenously,     weekly for 4 weeks in the treatment of patients with advanced malignancies refractory to     conventional anti-cancer treatment.   "
131644|NCT01561898|"     The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients     with schizophrenia over a long term period.   "
131645|NCT01561885|"     The aim of this study is to determine if by providing a collaborative, integrated     pathway-based healthcare compared to the usual healthcare, whether or not this would be     superior in reducing the length of hospital stay across five high frequency /high risk     medical diagnoses: Acute Venous Thromboembolism, Acute Kidney Injury, Community Acquired     Pneumonia, Adult Left Ventricular Heart Failure, and Asthma.   "
131646|NCT01561872|"     2 URCC in the Limousin region will be equipped with the automated telesurveillance system.     Patient will be selected by ward's geriatrician and randomized into two groups after informed     consent. One group will have cameras installed and the other will not and will act as a     comparison group. Patient will be assessed twice during the study, at admission in (inclusion     visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard     geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral     disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as     adverse events and will therefore be listed along the study and characterized in types and     number.   "
131647|NCT01561859|"     The proposed project is designed to examine the effects of cognitive rehabilitation on brain     structure and function in a randomized trial of 102 early course schizophrenia patients     treated for 18 months with either cognitive enhancement therapy (CET) or an Enriched     Supportive Therapy (EST) control, and then followed-up at 1-year post-treatment.   "
131648|NCT01561846|"     In this study the investigators aimed at verifying whether consumption of a sheep cheese,     naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid     profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double     blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in     Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched     cheese for 3 weeks, with a cross over after 3 weeks of washout.   "
131649|NCT01561833|"     This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell     lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy     (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other     transformed T-cell lymphomas with the primary objective of studying the biological effects of     the multikinase inhibitor, sorafenib.   "
131650|NCT01561820|"     This is a small pilot trial of a 5 month aerobic exercise intervention in participants with     MCI (n=20) to begin to compare the effects of randomization to use an exercise buddy or to     exercise without an assigned buddy. The investigators hypothesize that participants with MCI     who exercise with a buddy will have higher adherence to the protocol and greater improvement     in 400 meter walk time.   "
131651|NCT01561807|"     The purpose of this study is to determine the antiviral activity and safety of VX-787 given     to healthy adult volunteers that have been inoculated with the influenza virus.   "
131652|NCT01561794|"     The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the     relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and     Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in     hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory     disease with severe disease or a poor response to other antimicrobials. In addition, the     efficacy of the ciprofloxacin, in terms of clinical response and microbiological response,     will be investigated, but as a secondary endpoint.   "
131653|NCT01561781|"     This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin     administered alone and in combination with Vandetanib.   "
131654|NCT01561768|"     The purpose of this study is to determine the immune response of three dose levels of the     Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5     treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3     will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will     receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially     available trivalent influenza vaccine (TIV). The study will also evaluate the safety and     tolerability of the Novavax Quadrivalent vaccine.   "
131655|NCT01561755|"     The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an     effective treatment for HIV associated myelopathy.   "
131656|NCT01561742|"     This study aims to examine the efficacy of minocycline augmentation in a sample of moderately     ill outpatients with early-course schizophrenia on their chlorpromazine-equivalent doses of     second-generation antipsychotic medications. The investigators hypothesize that as compared     to placebo a 2-month treatment with minocycline in 120 volunteers with early-course     schizophrenia will result in a more significant improvement in psychopathology (primary     outcome) and cognitive symptoms (secondary outcome). In addition, cytokine plasma levels will     be used as another secondary outcome measure to see if treatment-induced changes in total     PANSS score are associated with changes in cytokine levels.   "
131657|NCT01561729|"     This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if     there is proper placement of a nasogastric or orogastric tube.   "
131658|NCT01561716|"     The purpose of this study is to provide energy expenditure data on Wii Fit / Wii Fit Plus     games as compared with resting and treadmill walking/running.   "
131659|NCT01561703|"     This study is designed to look at healthcare utilization following the removal of tonsils and     adenoids in pediatric patients who are not given an antibiotic following surgery.   "
131660|NCT01561690|"     This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the     effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent     asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the     US will be enrolled in this study.   "
131661|NCT01561677|"     Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little     is known about the consequences of OSAS on the outcome and the survival after stroke. The aim     of the investigators study is first to evaluate the outcome and the survival of patients with     stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome     and survival of patients with severe OSAS depending on the treatment of the syndrome with     nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is     associated with worst survival and outcome and needs to be treated at the subacute phase of     stroke.   "
131662|NCT01561664|"     Insulin resistance is one of the main mechanisms involved in metabolic diseases. inflammation     has been implicated in its pathogenesis, due to innate immunity activation by free fatty     acids, lipopolysaccharides (LPS) and lactate. Free fatty acids, LPS and lactate activate     innate immunity in squelettal muscle and adipose tissue via Toll-like receptor 2/4, NFkB,     IRF3 (Interferon Responsive Factor 3) and cytokines secretion (TNFa, IFN g, IL1b, IL6),     chemokines secretion (MCP1) and leukotrienes (LTB4). Feed back mechanisms involved in TLR     signaling pathways as RLI (ribonuclease L inhibitor)/ABCE1, have never been studied in     inflammation due to obesity. RLI inhibits an endoribonuclease, RNase L, which has been     recently implicated in TLR signaling The purpose of this study is to analyse the role of RLI     and RNase L in TLR regulation, and its potential implication in the link between obesity,     inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.   "
131685|NCT01561365|"     The aim of this prospective study was to compare outcomes in patients handled by emergency     physician according to OAR versus by an orthopedic resident.      92 consecutive patients with ankle injuries attending our emergency department were divided     in two groups. The study group comprised 32 patients who arrived during the morning shift and     were examined by an emergency physician according to OAR. Patients discharged without an     x-ray were followed in the clinic or by telephone communication. The control group     constituted 60 patients who were examined during the evening and night shifts by orthopedic     residents unaware of this study.   "
131663|NCT01561651|"     Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all     strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as     coumadin. Although these blood thinners are effective, they are limited by the risk of     serious bleeding, by physician and patient reluctance to use, and by noncompliance and     discontinuation. The left atrial appendage is a structure on the upper chamber of the heart     that is the most common source of stroke in patients with AF. This structure is easily     accessible during open heart surgery for removal, and has been an area of interest for stroke     prevention. However, there is currently no strong evidence that removing it works.      The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF     undergoing heart surgery for other reasons to have the left atrial appendage removed or not.     These patients, other than this small procedure which has been shown to be quite safe, will     be treated in the usual manner. The full study of 4700 patients, followed for an average of 4     years, will determine if removing the left atrial appendage can reduce stroke and other     complications on top of usual therapy. A positive study will change the way heart surgery is     performed on AF patients and results in a large reduction in the number of strokes in a large     population. Further, it will promote further research into this approach that could be     applied beyond AF patients undergoing heart surgery.   "
131664|NCT01561638|"     The pulsed dose RF treatment in various painful disorders may provides better pain relief     with longer duration compared to previous Pulsed Radiofrequency (PRF) treatment in similar     clinical settings. Also, there would has not been any worrisome complications from the     procedures.   "
131665|NCT01561625|"     Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary     disease (COPD). Although resistance exercises increase strength and muscle mass in patients     with COPD, the response to training appears to be suboptimal in these individuals. A     dysregulation in the signaling pathways involved in the regulation of muscle mass could play     an important role in this phenomenon.      Hypothesis: Proteins involved in muscle mass regulation will be less activated in the     quadriceps of patients with COPD following the acute bout of resistance training exercise     compared to healthy age-matched controls.   "
131666|NCT01561612|"     The overall goal of the PROBIT study is to investigate the influence of a randomized     breastfeeding promotion intervention designed to increase the duration and exclusivity of     breastfeeding (the breastfeeding promotion intervention) on the development of maternal and     child health outcomes. The hypothesis is that randomization to the intervention will be     associated with lower child adiposity, lower risk of asthma and atopy, improved lung     function, and improved cognitive outcomes.   "
131667|NCT01561599|"     The study is designed to evaluate the safety and efficacy of an intravenously administered     drug in recipients of kidneys from cardiac death donors who are risk for developing delayed     graft function.   "
131668|NCT01561586|"     Current standard treatment for locally advanced cervical cancer is cisplatin-based concurrent     chemoradiation (CRT). Although recently reported meta-analysis studies also demonstrated     improved local control rates and survival with cisplatin-based chemotherapy concurrent to     radiation therapy (RT), the optimal cisplatin dose and dosing schedule are still     undetermined.      In light of the results of the previous clinical trial, weekly cisplatin 40 mg/m2 considered     to be a standard regiment in cisplatin doses and dosing schedules. However, our randomized     phase II trial showed that tri-weekly cisplatin 75mg/m2 has lower toxicities and a better     outcome in locally advanced cervical cancer.      In this randomized phase III trial, the investigators investigate that there may be a     survival difference between weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2     administration concurrent to RT in cervical cancer.   "
131669|NCT01561573|"     PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in     the evaluation and reduction of colles fractures as compared with traditional pre and post     reduction radiographs. With the objectives of assessing Emergency Ultrasounds (EU) utility in     guiding reduction attempts of Colles fractures and to compare EU to x-ray for the final     assessment of reduction adequacy.   "
131670|NCT01561560|"     The purpose of this crossover study was to evaluate the end-of-day comfort of two     commercially available, daily disposable, silicone hydrogel contact lenses.   "
131671|NCT01561547|"     Mothers can provide pain relief to their newborns, even in the context of intensive neonatal     care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane     review, that mothers holding their infants in a bare-chested skin-to-skin position, known as     Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful     procedure. While evidence is compelling, leading to recommendations for its use, to date     there is not a single study on the repeated efficacy to reduce pain. Current guidelines     recommend sweet taste for minor painful procedures. Although there is some controversy about     its continued use in this population based on one study with negative neurodevelopmental     outcomes as well as its potential interaction with dopaminergic development, oral sucrose     (sweet taste) remains efficacious in decreasing pain response over several weeks. The     combination of KMC and sucrose is marginally more potent, but again, long term use remains     unstudied.      AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to     usual care (sucrose), and of KMC in combination with sucrose by examining each condition at     least three times during NICU stay. A secondary aim is to compare these interventions on     neurodevelopment at discharge from the NICU.   "
131686|NCT01561352|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     assess the efficacy of activated recombinant human factor VII in the treatment of refractory     haemorrhagic cystitis (HC) following chemotherapy.   "
131699|NCT01561170|"     Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous     insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of     the disease, primarily among elderly people. Recently, electromagnetic field therapy has been     tested on various diseases in musculoskeletal system with a beneficial effect. In recent     years, there has been an increasing interest in using electromagnetic field therapy to treat     chronically venous ulcer.      The hypothesis of the investigators is that the electronic magnetic field therapy improves     the healing process and reduces pain for patients suffering from chronically venous ulcer.     The investigators assume that the bioactivity is affected by a cellular response which     affects the DNA synthesis, transcription og protein synthesis.   "
131672|NCT01561534|"     The rehabilitation of patients affected by defects of the jaws after tumor resection is still     very challenging. Resection can lead to significant facial deformity, impaired oral functions     such as speech, swallowing, saliva retention, and concomitant psychological problems.     Moreover, the loss of teeth and the alveolar and basal jawbone can lead to significant     impairment of mastication. The reconstruction of such defects with autogenous bone grafts or     revascularized free flaps has become a valuable means for the rehabilitation of these     patients. Major benefits of such procedure include an usually low morbidity of the donor site     and an extensive length of the bone graft. Moreover, vascularized grafts provide a good bulk     of bone in which to place implants and a satisfactory contour. In fact, after reconstruction,     local hard and soft tissue conditions often exclude the integration of conventional dentures     because of the impairment of dental prosthetic retention by thin cutaneous tissue, the     thickness of subcutaneous tissues, the absence of a perilingual and vestibular groove, and     the fragility of soft tissues. In Literature it has been well established the high biologic     value of vascularized fibula grafts regarding the potential of implant osseointegration,     which seemed to be equal to regional mandibular or maxillary bone and eventually capable to     provide sufficient stabilization of prosthesis.      It must be kept in mind that the final prosthetic success may be affected by some     difficulties in this clinical scenario. These include the limited opening of the     scar-contracted oral cavity, the huge amount of soft tissue covering the fibula, with little     information about the profile of the underlying harvested bone, the need for limited bony     exposure in a field that may well have been irradiated and they all may cause poor     prosthetically-guided implant positioning and eventually disappointing results in dental     rehabilitation, either functionally or esthetically. It can be postulated that these     complications can be overcome, or at least reduced, by adopting the new methods of computed     tomography (CT)-assisted implant surgery.   "
131673|NCT01561521|"     The purpose of this study is to evaluate the onset and duration of action of two     concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen     challenge (CAC) model of acute allergic conjunctivitis.   "
131674|NCT01561508|"     Type 1 diabetes mellitus (T1DM) is an autoimmune disease in which the body's immune system     attacks and destroys the insulin producing beta cells of the pancreas. This condition is very     prevalent, affecting up to 1:400/500 persons worldwide. Type 1 diabetes, previously known as     juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood, but lasts     for a lifetime. To date, there have been no treatments that can arrest or reverse the ongoing     beta cell destruction. The patients affected by this disease require multiple daily insulin     injections to manage their blood sugars and usually have trouble regulating their blood     sugars. Moreover, they are at risk for heart disease, kidney failure, eye problems, and other     complications from this life-long condition.      The investigators plan to utilize gamma-amino butyric acid (GABA) in children with newly     diagnosed T1DM. This neurotransmitter is made in the brain from the amino acid glutamate with     the aid of vitamin B6. There have been some recent studies in diabetic mice utilizing GABA to     reverse inflammation on the pancreas and improve hyperglycemia. GABA studied in healthy human     subjects demonstrated that large oral doses of GABA increased insulin secretion from the     pancreas.      The investigators propose that GABA given to children with new onset T1DM will be able to     increase insulin production, suppress glucagon release, and decrease the inflammation     surrounding the pancreas. The investigators hope this will at least prolong the beta cell     life after diagnosis, if not lead to a cure for type 1 diabetes.   "
131675|NCT01561495|"     This is a study of proton radiotherapy for the pre- or post- operative treatment of patients     with extremity sarcoma. This study will treat patients in two dose groups:        1. patients receiving pre-operative proton therapy and        2. patients receiving post-operative proton therapy. In each dose group, the study is          divided into two phases. In the first phase of the study, the investigators will          determine if treatment with proton therapy is safe and can be delivered on a regular          basis. In the second phase, the investigators will determine if proton therapy has less          long term side effects compared to standard radiation in both pre-operative patients and          post-operative patients.   "
131676|NCT01561482|"     The purpose of this study is to find out whether the two drugs used in the study, metformin     and simvastatin, can slow down the speed of rise of prostate specific antigen (PSA) or stop     its rise or even bring the level down.      Recently, scientists noticed that men who take metformin to treat their high blood sugar or     simvastatin to treat their high cholesterol are less likely to develop prostate cancer. Also,     scientists found that, when these drugs are used in preclinical studies, they can slow down     the growth of the prostate cancer cells. This study will try to find out whether these drugs     can actually slow down the growth of prostate cancer in men.   "
131677|NCT01561469|"     The objective of this study is to review the local management of patients with     methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with     vancomycin or linezolid with the goal to define if any difference exists among these     antimicrobials in regard to clinical and economic outcomes.   "
131678|NCT01561456|"     The purpose of this study is to compare effectiveness and safety of experimental anticancer     medicine, AXL1717, and docetaxel in patients with squamous cell carcinoma or adenocarcinoma     of the lung.   "
131679|NCT01561443|"     This is the first study focused on features/stereotypes of the first and second-line     treatment patterns in Russia, comparison of different treatments, and determination of     effective hormone treatment patterns in real-life practice with evaluation of     pharmacoeconomic aspects. Study LINE is designed for collection of data on clinical     effectiveness of second-line hormone treatment and quality of life in patients with breast     cancer(BC).   "
131680|NCT01561430|"     The purpose of this Phase 2 study is to evaluate how the body handles the drug and the drug's     effect on the body of participants with mild cognitive impairment (MCI) due to Alzheimer's     Disease (AD) or mild AD who test positive for amyloid plaque.   "
131681|NCT01561417|"     This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence     between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a     new formulation stable at 25°C (VII25).   "
131682|NCT01561404|"     This is an exploratory study based on the hypothesis that kidney transplant patients treated     with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin     (m-TOR) may increase resistance to physical exercise, which would result in an improvement in     the quality of life of these patients.   "
131683|NCT01561391|"     This trial is conducted in North America. The aim of this trial is to compare the safety and     efficacy of activated recombinant human factor VII in patients with haemophilia A or B     undergoing major surgical procedures.   "
131684|NCT01561378|"     The goal of this study is to determine the potential ability of intranasal insulin to prevent     post-operative cognitive decline and post-operative delirium in an elderly cardiac surgery     population.   "
131687|NCT01561326|"     Objective: Previous studies have suggested that psycho-educational interventions delivered by     telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further     explore strategies for enhanced follow-up to medical care recommendations, we studied the     impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at     2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive     telephone barriers intervention was compared to an enhanced comparison group and a group that     received tailored print materials.      Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly     assigned to: 1) telephone assessment of barriers to follow up adherence recommendations     combined with tailored telephone barriers counseling; 2) telephone assessment combined with     tailored barriers print brochure; or 3) telephone assessment with no barriers counseling.     Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.   "
131688|NCT01561313|"     This study will compare injection site pain levels between current Humira® formulation versus     a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either     currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological     naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The     study is being conducted in two countries, Belgium (3 sites) and the Czech Republic (3     sites).   "
131689|NCT01561300|"     This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract,     equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.   "
131690|NCT01561287|"     Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer     patients undergo some form of breast reconstruction. Several types of reconstructive     procedures are available for appropriate patients. A reconstructive sequence consisting of a     tissue expander followed by permanent implant placement is a popular choice for many women.     In the past several years, acellular dermal matrices (allografts) have been used at the time     of tissue expander placement to extend submuscular coverage. Reported benefits include the     ability to initially fill the expander to a greater extent, improved control of the     inframammary crease, and possible decrease in capsular contracture rate. Potential     disadvantages of dermal allografts include foreign body reaction, incomplete tissue     integration, or increased infection rates. The latter is especially worrisome, as infection     in the setting of a tissue expander often necessitates the removal of the implant and     interruption of the reconstructive sequence. There have been a few scattered reports of the     use of dermal autografts in implant-based breast reconstruction, but they have not been     widely used. Dermal autografts carry the potential benefit of improved tissue integration and     lowered complication rates. However, to date there have been no studies which compare     acellular dermal allograft matrices to dermal autograft for use in breast reconstruction. The     objectives of this study are to compare dermal allograft to dermal autograft with respect to     cost, tissue integration, patient satisfaction with scar, and complication profile in     patients undergoing mastectomy followed by tissue expander/implant reconstruction.   "
131691|NCT01561274|"     Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery.     Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is     one cause of this hypotension. The higher the spread of the blockade will result in a higher     incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread     within the intrathecal space before it will be taken up by the nerve roots. The time that a     patient remains in one position after medication injection will affect the spread of the     resultant anesthetic block. A patient who is left sitting for a longer period of time after     injection of hyperbaric medication will have a lower level of block than someone who is     placed supine immediately. In this study, the investigators wish to use up down sequential     analysis to determine the time period a patient should remain seated after intrathecal     injection of hyperbaric bupivacaine that will result in a 50% rate of hypotension.   "
131692|NCT01561261|"     The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis     of acute compartment syndrome (ACS).      The immediate objective is to develop a model to accurately predict the likelihood of ACS     based on data available to the clinician within the first 48 hours of injury (specific     clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy     (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).      Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome     made by a panel of clinicians using the following data:        -  A physiologic fingerprint composed of continuous pressure versus time curve,          continuous oximetry values, response of muscle to fasciotomy when performed, and serum          biomarkers of muscle injury (CPK levels).        -  Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle          function, presence/absence of myoneural deficit, and patient reported function using the          Short Musculoskeletal Function Assessment (SMFA).   "
131693|NCT01561248|"     The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli     (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop     hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.   "
131694|NCT01561235|"     Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how     protein exerts its effect on appetite is not fully known. The effect have been suggested to     be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also     to a greater thermogenic effect causing greater increase in core temperature. The involvement     of peripheral appetite-regulating hormones has only been sparingly investigated.      The objective is to investigate the satiating effects of meals with varying content of     meat-based protein and whether a dose-response effect can be found on appetite-regulating     hormones and appetite ratings.      Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The     test meals is isocaloric with 30E% fat and increasing protein content at the expense of     carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein     content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite     ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will     served an ad libitum lunch.   "
131695|NCT01561222|"     Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression     so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.   "
131702|NCT01561131|"     The primary aim is to examine the effect of a high protein intake (from soy or whey protein)     on weightmaintenance after weight loss in a group of predisposed (severe) obese persons.     Furthermore, to examine short-term and long-term effect of a high protein intake on appetite     regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on     weightmaintence, bloodlipid profilen, appetite regulation and DIT.      The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet)     and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese     subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy     protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0),     after the WL period (week 8) and after WM period (week 24) body weight and composition will     be measured and blood samples will be collected. Meal test will be performed at week 0 and 24     (examining both appetite regulation and DIT). Urine and feces will be collected three times     during the study. Subjects will receive dietary counseling (in groups) regularly during the     study and body weight will be measured at each visit.   "
131703|NCT01561118|"     Physical activity is considered essential for optimal health, development, socialization and     well-being of children. However patients with end-stage renal disease (ESRD) are often     restricted from participation in exercise activities. This is especially true for children on     hemodialysis (HD). As a consequence their exercise capacity is reduced, both before, but most     impressively after HD. In a nationwide randomized, multi-center design this study aims to     proof the influence of an individualised endurance training program by bicycle ergometer     performed during dialysis on the efficacy of HD, measured as single pool Kt/V. Secondary     goals are to enhance physical performance, physical and mental well-being, and to improve     measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). A     positive impact of physical activity was observed in adults on HD, although most studies did     not address this issue in a randomised protocol. Despite this beneficial evidence in adults,     sport is still not integrated as part of standard care in patients on maintenance HD. The     study protocol, developed in close collaboration with the German Sport University Cologne,     differs substantially from previously published reports as it uses bicycle ergometer training     in an upright position outside the dialysis couch and adapts the intensity of intervention to     the patient's capabilities. Based on the expected results the investigators will develop an     individualised training program to be integrated in the standard care of (pediatric) patients     on maintenance HD.   "
131704|NCT01561105|"     Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to     Collaborative Treatment(IMPACT) collaborative care management program for late-life     depression.   "
131705|NCT01561092|"     Growing international scientific evidence has indicated a positive effect of SSRI treatment     (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to     conduct a prospective randomised double blind placebo-controlled multicenter study of the     combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion     of the SERT (serotonin transporter) gene may influence this treatment effect and may in     itself be a risk factor for stroke, an aspect we also wish to explore.      Hypotheses:        1. SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new          thromboembolic events and leads to better rehabilitation.        2. A specific SERT genotype is associated with an increased risk of first ever stroke.        3. A specific SERT genotype is associated with a higher risk of post stroke depression.      600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1     ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6     months. During these 6 months there will be 2 clinical follow up visits, one telephone     control and one visit to evaluate compliance regarding medication. Patients who had an MRI as     a part of the routine investigations done upon admission (approximately 300 patients) will     have a control MRI after 6 months.      Additionally 400 patients, not eligible for participation i the randomised controlled trial,     will be genotyped and answer questionnaires after 1 and 6 months.   "
131706|NCT01561079|"     This research will track the longitudinal neurobehavioral development of the     buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine     the safety of this medication for use during gestation, the relationship between maternal     physiologic changes due to buprenorphine administration and newborn functioning, and to     determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence     Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar     project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way     the investigators inform the treatment of the opioid dependent woman during pregnancy and her     infant after birth.   "
131707|NCT01561066|"     Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output     enterocutaneous fistulas. However, there are only few studies that report autologous glue     application in a larger patient group or clinical-controlled studies in this setting. The aim     of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin     glue (PRFG) in the treatment of low-output digestive fistulas and compare them with     conservative management without the use of adjuvant application of FG into the fistulous     tract.   "
131708|NCT01561053|"     The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral     and global domains based on the different applicable psychometric batteries and scales.   "
131709|NCT01561040|"     Dry eye disease (DED) is a common but often inadequately treated disease of the tears and     surface of the eye. It can cause poor vision and chronic pain and is more frequent with     increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical     Trials in Dry Eye defined dry eye as a disorder of the tear film due to tear deficiency or     excessive evaporation, which causes damage to the interpalpebral ocular surface and is     associated with symptoms of ocular discomfort. The International Dry Eye Work Shop (DEWS)     committee subsequently defined dry eye as a multi-factorial disease of the tears and ocular     surface that results in symptoms of discomfort, visual disturbance, and tear film instability     with potential damage to the ocular surface. It is accompanied by increased osmolarity of the     tear film and inflammation of the ocular surface. Typically, symptoms associated with dry     eye disease include ocular burning, foreign body sensation (sand or grit), photophobia (light     sensitivity), and other symptoms that result in overall long term discomfort in patients. The     proposed eight week feasibility study if dry eye subjects confirmed elevated osmolarity and     symptoms respond to nutritional therapy.   "
131711|NCT01561014|"     This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when     given together with oxaliplatin, fluorouracil, and radiation before surgery and alone after     surgery in treating patients with locally advanced cancer of the esophagus and     gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy     x-rays to kill tumor cells. Giving combination chemotherapy together with erlotinib     hydrochloride and radiation therapy before surgery may make the tumor smaller and reduce the     amount of normal tissue that needs to be removed. Giving erlotinib hydrochloride after     surgery may kill any tumor cells that remain after surgery   "
131712|NCT01561001|"     Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous     humor via the trabecular meshwork towards the systemic circulation. This may lead to an     increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to     lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss.     Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains     uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be     indicated. Deep sclerectomy with a collagen implant (DSCI) is a non-penetrating surgical     procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous     outflow. This forms the rationale to conduct this prospective, open label study to assess the     24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and     after DSCI.   "
131713|NCT01560988|"     This study plans to look at whether borage and echium seed oils (natural oils from two     plants) help decrease asthma symptoms and affect cells involved in inflammation. The     investigators also want to look at how these plant oils decrease the generation of     inflammatory cells in people with asthma.   "
131714|NCT01560975|"     Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in     the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common     sleep-related breathing disorder and is characterized by repeated partial or complete upper     airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the     diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called     respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous     positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The     association between OSAS and glaucoma has been extensively studied, although a few reports     have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading     to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic     neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure     (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime.      The purpose of this study is to investigate how IOP varies in time, particularly during sleep     in OSAS patients with or without glaucoma, and if the IOP variations are associated with the     use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable     investigational device using a contact lens sensor that monitors the IOP fluctuation     continuously over 24-hours.   "
131715|NCT01560962|"     Objective: To determine the preliminary outcome of external over the counter (OTC) povidone     iodine (PI) application in the management of chronic and acute blepharitis vs. currently     clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or     antibiotic/steroid ointments.      Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled     and randomized into four groups.      In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI     twice daily for 10 days and the other eye with no intervention.      In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI     and the other eye will receive warm soaked eyelid wash.      In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI     and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10     days.      In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI     and the other eye will receive tobradex ointment applied to the lid margin.      Subjective variables assessed included itchiness, foreign body sensation and eyelid edema     (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland     plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the     initiation and at the cessation of treatment were obtained.   "
131716|NCT01560949|"     The goal of this clinical research study is to learn if a chemotherapy combination called     modified Folfirinox (or mFolfirinox), followed by a combination of gemcitabine and radiation     therapy, followed by surgery, can help to control pancreatic cancer. The safety of this     treatment will also be studied.      mFolfirinox consists of 5-FU, oxaliplatin, and irinotecan. These 3 drugs, along with     gemcitabine, are each designed to block the growth of cancer cells, which may lead to cancer     cell death.   "
131717|NCT01560936|"     The purpose of this study is to determine the contamination rate of the parents cell phone in     a newborn intensive care setting and identify the types of bacteria contaminating the cell     phone as well as evaluating the effectiveness of an antimicrobial gel in reducing the     transmission of bacteria from the cell phone to the parents hands.   "
131718|NCT01560923|"     This is a randomized, double blind, multi-institutional phase II therapeutic study of     Indoximod or placebo after the completion of standard of care sipuleucel-T (Provenge®) in men     with asymptomatic or minimally symptomatic metastatic prostate cancer that is castration     resistant (hormone refractory). Patients are randomized to receive either twice daily oral     Indoximod or placebo for 6 months beginning the day after the third and final sipuleucel-T     infusion.   "
131719|NCT01560910|"     Study design and objective The primary outcome of this prospective cohort study was to     identify the endoscopic findings that have diagnostic value for the prediction of NERD     (minimal change esophagitis) by using HD endoscopy with i-scan. The secondary outcome was to     evaluate the response to proton pump inhibitor (PPI) in GERD patients with or without minimal     change esophagitis.   "
131720|NCT01560897|"     The aim of this pilot study is to evaluate the validity and reproducibility of a functional     test Test C13 ureogenesis to measure in vivo, using the methodology Laboratory of Metabolic     Diseases of Cliniques Universitaires Saint-Luc   "
131721|NCT01560884|"     The purpose of this trial is to study safety, tolerability, and phosphate binding capacity of     Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with renal     failure. Renal excretion of phosphate is expected to decrease and fecal excretion of     phosphate is expected to increase after treatment.   "
131722|NCT01560871|"     Patients with chronic heart failure need a safe and effective exercise program that will     improve their quality of life. For this study, we will determine if adult chronic heart     failure patents assigned to an experimental exercise group of walking and Inspiratory Muscle     Training (IMT) program will have an additional beneficial effects on respiratory muscle     strength (PImax), cardiovascular endurance, quality of life, walking speed, heart rate     variability, and physical activity level compared to subjects who are assigned to the home     walking and sham Inspiratory Muscle Training (IMT) program.   "
131723|NCT01560858|"     The purpose of the protocol is to describe treatment patterns among patients with prostate     cancer prior to diagnosis of castration-resistant state.   "
131724|NCT01560845|"     In recent years, the safety and efficacy of autologous bone marrow stem cells infusion     (ABMSCi) therapy were confirmed. The investigators attempted to infuse autologous bone marrow     stem cells (ABMSC) through inserting a catheter into right gastric artery as far as proper     hepatic artery after finishing open abdominal portal hypertension surgery. The present study     was designed to treat bleeding from esophageal varices and hypersplenism and hopefully to     improve the liver function as well.   "
131725|NCT01560832|"     Clostridium difficile is an important pathogen, causing disease that ranges from mild     self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C.     difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and     for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two     large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical     illness. Primary risk factors for C. difficile clinically apparent infection include     antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥     65 years), and increased length of hospital stay. The incidence of CDI both in the hospital     and the community is important in the understanding and characterization of the disease and     its prevention. This observational, epidemiological study will advance the investigators     understanding of CDI risk factors in several hospitals and possibly the community in the Asia     Pacific region.   "
131726|NCT01560819|"     Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder     affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2     different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut     Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a     treatment option for Clostridium difficile colitis and UC. The literature supports strong     evidence for the plausibility of using GMT for patients with IBD associated colitis,     especially for patients with UC.      This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric     gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to     evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis     (UC and CD with colonic involvement only) will be approached for GMT as a treatment option     for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily     on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be     done at their regularly scheduled clinic follow up.      Healthy donors >18 years of age will be chosen by the family, inclusive of immediate family     members and friends. Donors will be required to complete a screening questionnaire, provide     medical history, and undergo blood and stool tests.   "
131727|NCT01560806|"     A quasi-experimental study design was chosen to compare the model of hypertension management     at commune-level with conventional management for people with high blood pressure in two     communes (one for intervention versus one for reference).      A intervention model included the commune-based programme on hypertension management combined     with comprehensive health promotion campaigns   "
131728|NCT01560793|"     This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a     recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of     doses.   "
131729|NCT01560780|"     This is a randomized-controlled clinical trial that will randomize 120 patients undergoing     clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg     daily or matching placebo for 12 months, starting at the time of hospital dismissal from     surgery. The primary goal of the study is to determine whether prasugrel administration will     prevent thrombus (clot) formation within a saphenous vein graft at 12 months, as examined by     optical coherence tomography.   "
131730|NCT01560767|"     Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac 30mg     reduces postoperative pain following primary total knee replacement compared with the current     standard treatment of femoral nerve blockade.   "
131731|NCT01560754|"     The primary objective of this study is to demonstrate that transdermal nicotine treatment     retards disease progression as measured by change in total Unified Parkinson's Disease Rating     Scale (UPDRS)(part I, II, III)score between baseline and after 52 weeks of study treatment     plus two more months wash out (60 weeks).   "
131732|NCT01560741|"     The critical nature of respiratory diseases, the continuously increasing prevalence of these     conditions, and the subjective perception of patients vis-à-vis their pulmonary function and     health status underscore the importance of home telemonitoring. These conditions are critical     and necessitate close and regular monitoring that may be achieved at distance using     telemonitoring. This study will assess a number of measures both at baseline and     post-intervention from a number of domains, including Arterial Blood Gases (ABG),     BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life,     patients satisfaction and utilization of healthcare resources.   "
131762|NCT01560351|"     The aim of this study is to evaluate the effect of repeated low-frequency Transcranial     Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with     gambling cues, on gambling craving. Participants are pathological gamblers. A single real     stimulation and a single shame stimulation are administered in a random order for each     participant (cross-over study).   "
144630|NCT01391299|"     This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo     for the treatment of forehead lines (facial rhytides) when also administered to frown lines     (glabellar rhytides).   "
131733|NCT01560728|"     Youth with mental illnesses are disproportionately represented in juvenile correctional     facilities and limited evidence exists about effective treatments in this setting. This study     will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be     efficacious in community settings, to the correctional setting and study the feasibility of     its implementation. Conducted within Texas youth correctional facilities, the findings will     be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the     unique needs of incarcerated youth and the correctional system, one of the priorities     outlined in the National Institute of Mental Health Strategic Plan.   "
131734|NCT01560715|"     The purpose of this study is to evaluate the short-term safety and efficacy of a single     intravitreal injection of autologous bone marrow stem cells in patients with retinitis     pigmentosa.   "
131735|NCT01560702|"     Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.   "
131736|NCT01560689|"     The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective     in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.   "
131737|NCT01560676|"     Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills     training delivered to high school students on BMI, nutrition and physical activity behaviors,     and self-efficacy over 6 months.   "
131738|NCT01560663|"     Neoadjuvant (preoperative) chemotherapy is an interesting research tool which allows     investigators to test new drugs and/or new schedules with a validated surrogate endpoint,     pCR. It also represents an ideal model to evaluate the relationships between treatments and     tumor biomarkers. Recent publications have shown that new molecular classifications of breast     cancer (intrinsic subtypes) have an important prognostic and predictive value. Using     microarrays for gene expression profiling seems to be the best way to perform this     classification; nevertheless such assays are not optimally available for common clinical     practice. The IHC-based classification systems are still useful, as fresh tissue is not     normally available in clinical practice, and has been shown to correlate well with intrinsic     classification using gene expression microarrays. Recently the PAM50 gene set provided a risk     of relapse score not only in ER-positive, node negative patients (similarly to the Oncotype     Dx Recurrence Score) but also in the ER negative disease. Additionally, the PAM 50 assay was     highly predictive of neoadjuvant response when considering all patients. This assay added     significant prognostic and predictive value to pathologic staging, histologic grade, and     standard clinical molecular markers while using an easy technique that can be performed in     clinical practice because the qRT-PCR assay can be performed using FFEP tissue.      Triple Negative Breast Cancer (TNBC) is defined by a lack of expression of ER, PgR and HER-2.     DNA microarray profiling studies have led to the classification of invasive breast carcinoma     into five subtypes: luminal A and B, normal breast-like, HER2/neu overexpressing and     basal-like subtypes, with clinical implications. Later on, a new subtype, the claudin-low,     has been described. Although not synonymous, the majority of TNBCs carry the basal-like     breast cancer (BLBC) molecular profile.      The triple negative subtype accounts for 11-20% of breast cancer in different studies,     whereas in selected cohorts of patients with advanced breast cancer or African-American     ethnicity, TNBC may be diagnosed among as many as 23-28%.      Patients with TN breast tumors treated with standard chemotherapy have a shorter DFS and OS     than non-TNBC, this difference have been shown to be independent from tumor grade, nodal     status and treatment in some studies. The peak risk of recurrence occurs within the first 3     years after initial treatment, with the majority of deaths occurring in the first five years.      Chemotherapy remains the only systemic treatment option available for TNBC patients. Several     studies have shown that TNBC/BLBC is associated with an increased response rate to     neoadjuvant chemotherapy when compared with luminal tumors. However, TNBC patients have a     significantly decreased DFS and OS in comparison with luminal patients. The largest study     exploring response and survival in early stage breast cancer treated with neoadjuvant     chemotherapy was reported by Liedtke et al. Although an increase pCR rate was observed among     the TNBC patients, they had a shorter lifespan than the non-TN ones. Patients experiencing     pCR had an excellent OS regardless of hormone receptor expression, but patients with residual     disease had a significantly shorter survival associated with TNBC compared with non-TN ones.     This demonstrates that poor OS is derived from chemo-resistant patients (what unfortunately     represent > 50% of them).      A relevant problem is the differential response to drugs of TN tumors. These tumors are     usually treated with multidrug combinations including anthracyclines and taxanes, with pCR´s     of 28-32%. Only recently, the results of a few small trials combining platinum salts and     taxanes have been reported, with encouraging results (pCR of 44-77%). The taxane-platinum     salt combinations have a biological background, since TN not associated BRCA1 mutations are     sensitive to taxanes and resistant to anthracyclines and platinum salts are effective in TN     tumors probably because a significant proportion of them have functional DNA repair     deficiencies.      The primary objective of the study is to identify predictors of response to     docetaxel-carboplatin in patients with triple negative primary tumors. Response is defined as     lack of invasive tumor in breast plus axilla after neoadjuvant chemotherapy (PCR,     pathological complete response).   "
131739|NCT01560650|"     The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses     of 35 ml/kg/h is better, but the result is according to white people, black people . It is     Whether the best amount of replacement fluid for Chinese people, it is unclear.     Especially,there is little evidence about the optimal dose from randomized trials in Cardiac     surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical     situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14     days, 28 days, 90 days survival and renal function.   "
131740|NCT01560637|"     This study is an international, multi-center, open-label study designed to provide oral     treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have     completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety     of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.   "
131741|NCT01560624|"     This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C):     placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial     Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30     days at randomization for their PAH. Study visits will occur in four week intervals for the     first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to     first clinical worsening event and the 6-minute walk test at Week 24. Study procedures     include routine blood tests, medical history, physical exams, disease evaluation, and     exercise tests. Patients who complete all required assessments will also be eligible to enter     a long-term, open-label, extension study (TDE-PH-311).   "
131742|NCT01560611|"     In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain     and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused.     This phenomenon is related to silent peripheral vasoconstriction that is not clinically     available but threatens end-organ perfusion and carries the risk of multi-organ failure. By     measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present     study aims at detecting silent peroperative hypoperfusion episodes. The investigators     hypothesize that gradient, measured during the surgical procedure, will predict the     occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate     concentration, measured in intensive care unit.   "
131743|NCT01560598|"     We aimed to risk faoctors for GERD and association between visceral obesity, plasma     adipoline(leptin, adiponectin, IL-6, TNF-α)and development of reflux esophagitis in healthy     Koreans.   "
131744|NCT01560585|"     This is an open label study of isotretinoin, a medication which is FDA approved for treatment     of other conditions to determine initial safety in Alzheimer's disease.   "
131745|NCT01560572|"     A prospective, open, randomized trial, in which the investigators aim to achieve optimal     immunosuppression after renal renal transplantation with maximal reduction of side effects,     especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies.     Immunosuppression without steroids and CNI minimization is compared to standard     immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.   "
131746|NCT01560559|"     Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and     Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient     in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as     surgical myotomy but less invasive and more effective with less complications than endoscopic     pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100%     efficacy and no clinically significant complications. The present clinical trial with study     the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.   "
131747|NCT01560546|"     A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.      Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by     hyperinsulinaemia and insulin resistance.      Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with     low normal levels of bioavailable testosterone and type 2 DM.   "
131748|NCT01560533|"     The project aims to understand better how patients live the event of cancer and live its     consequences on their bodily representations. In the study, the dynamic of the body image is     not restricted to appearance but include sensations and visions of the inner body, what     explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and     HIPEC.      The three objectives of the study are:        -  identifying the impact of the representations of the treated body on the psychological          strategies to cope with the disease, the bodily changes and the prospects of life;        -  making explicit the positive or negative impacts of these representations on the          relationship between patients and health professionals (easing factors,          misunderstandings, negotiations, etc.);        -  associating the health professionals with the study in its course and evaluation in          order to elaborate a methodological collaborative approach between patients, health          professionals and researchers in social sciences.   "
131749|NCT01560520|"     Stroke is the leading cause of adult disability in Europe and United States and the second     leading cause of death worldwide and affects more than 10,000 Danes each year.      Studies in a late and stationary phase after stroke have shown that physical rehabilitation     is of great importance for survival and physical ability of these patients, however many     studies show that patients lie or sit next to their bed under hospitalization for more than     88.5 % of the daily hours. Physical activity in stroke patients has never previously been     measured immediately after debut of symptoms; furthermore there is no knowledge about the     optimal dose of physical rehabilitation for these patients.      Accelerometers, small measuring devices, are a relatively new way to measure physical     activity precisely, and hence it is possible to obtain an objective measure of how active     stroke patients are in the first week after admission. The accelerometers measure a variable     voltage, depending on the range and intensity of movement. They can measure movement     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.     Studies confirm their reliability, even in patients with abnormal gait, such as stroke     patients.      Another approach of studying the effects of physical activity and rehabilitation is through     the examination of biomarkers. Studies have shown that biomarkers released during physical     activity can inhibit biomarkers released after tissue injury in the brain, as seen after     stroke. These brain biomarkers cause further damage and studies show that the higher the     levels, the higher the damage. It is therefore obvious to examine whether physical activity     rehabilitation can down regulate this destructive process in patients with stroke.      Clarification of physical activity in stroke patients immediately after debut of symptoms and     examination of both the biochemical aspects of physical rehabilitation as well as the optimal     dose of physical rehabilitation is of great importance for many patients, their relatives as     well as of a great socioeconomic importance.      The purpose of the project is to describe the amount and pattern of physical activity in     stroke patients in the first week after admission. The investigators hypothesis is that     patients are inactive for most of the time during hospitalization, activity being correlated     with severity of stroke, but not with age, BMI and sex.   "
131750|NCT01560507|"     The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an     adaptive treatment algorithm developed in previous clinical trials, in order to calculate     cost-effectiveness of the treatment; 2) the relationship between genotype and response to     cigarette smoking cessation treatment.   "
131751|NCT01560494|"     This study describes the development and validation of a structured training and assessment     curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that     residents trained using the STAC curriculum would demonstrate superior technical skills in     the operating room compared to residents that were trained using a traditional curriculum.   "
131752|NCT01560481|"     Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the     treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in     naive patients with type 2 diabetes.      The objective of this study is to evaluate the safety, tolerability and pK profile of     Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single     dose, in step A. In step A will be included 25 volunteers.      In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin     Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be     included 24 volunteers.   "
131753|NCT01560468|"     This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver     Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061     oral monotherapy will be safe in adults during and after liver transplantation and that     therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV     infection.   "
131754|NCT01560455|"     This study will examine use of two-stent versus one-stent techniques for patients with large     calibre bifurcation lesions including significant side branch disease.   "
131755|NCT01560442|"     The purpose is to study the relation between pupillary diameter measured under scotopic     conditions, and the pain thresholds measured at the time of peak and residual effect of     methadone/buprenorphine in opiate-dependent patients following a substitution program.   "
131756|NCT01560429|"     Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous     epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural     anesthesia (PCEA) is more effective but little research has compared the two methods     following thoracotomy. The current randomized, prospective clinical investigation did just     this. Following institutional ethics approval 52 patients scheduled for thoracotomy were     recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was     sited preoperatively. Postoperatively all patients were titrated on continuous epidural     infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3     on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined     randomization (either remained on continuous epidural infusion or they were switched to     receive 2/3 of the stabilized background dose via continuous epidural infusion with the     option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on     their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was     consumption of local anaesthetics/opioids. The secondary outcomes were worst pain and pain     while coughing (0-10 NRS).   "
131757|NCT01560416|"     Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in     other research studies and laboratory experiments. It has also been studied in phase I     trials, where the appropriate dosing has been determined. Ganetespib is considered an HSP90     inhibitor. By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells to     become resistant to treatment.      Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors. In doing so,     it can block the effect of estrogen on cancer cells. In addition, fulvestrant causes a     decrease in the number of estrogen receptors. Fulvestrant is a drug that is approved by the     FDA for treatment of metastatic, hormone receptor positive breast cancer, based upon the     results of phase III clinical trials.      In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It     is not known whether this is true in humans. In this research study, we are evaluating the     effect of the addition of ganetespib to fulvestrant in participants with hormone     receptor-positive, metastatic breast cancer.   "
131758|NCT01560403|"     This study is a 1-year open label extension study to collect long term efficacy and safety     data from patients who have completed approximately 2 years of dosing in Study CL0600-021.   "
131759|NCT01560390|"     The aim of the study is to evaluate the impact of ketamine associated to an opioid for     sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be     drive by nurses according to an algorithm. The investigators will evaluate the quantity of     opioates used in each arm and the safety of ketamine.   "
131760|NCT01560377|"     The purpose of this study is to demonstrate that NIR fluorescence angiography using the     PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT System or PINPOINT) can assess     viability of colon tissue during laparoscopic left colectomy. This information will provide     the surgeon with clinically relevant information in assessing whether or not the tissue has     adequate blood supply in the lower section of the colon prior to a colectomy.   "
131763|NCT01560338|"     The purpose of the study will help us understand the complex interaction between hypothermia     (cooling) and pharmacogenetics (how specific genes effect how drugs are handled), and their     impact on how routinely given sedation drug are broken down and used by the body when given     to children after cardiac arrest (when heart stops pumping blood) and are critically ill.   "
131764|NCT01560325|"     A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting     toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection     on twice-weekly schedule in patients with advanced solid cancers failed to standard therapy.     The usefulness of the this regimen is evaluated by response rate, progression free survival     and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI) or DWI.   "
131765|NCT01560312|"     Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic.     Patients with refractory hypertension will be randomized in 1:1 manner either to renal     denervation plus optimal medical antihypertensive treatment without spironolactone or to     antihypertensive treatment alone including spironolactone if not contraindicated. The primary     end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year     after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients.     Patients follow-up is planned for 3 years.   "
131766|NCT01560299|"     Iodine therapy is the best treatment for graves disease.Most patients receive methimozale     prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.      Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and     others prefer longer off - methimazole period which bothers most patients. This study aimed     to evaluate optimum time for methimazole discontinuation in graves disease.   "
131767|NCT01560286|"     The primary objective of the study is to evaluate the effect of dosing regimens of multiple     subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while     decreasing the frequency and severity of hypersensitivity reactions in patients with PKU.   "
131768|NCT01560273|"     The purpose of this clinical investigation is to evaluate the clinical outcomes of subject     with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™     Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry     Disability Index (ODI) improvement and success of fusion.   "
131769|NCT01560260|"     This phase II trial studies how well linsitinib works in treating younger and adult patients     with gastrointestinal stromal tumors. Linsitinib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth.   "
131770|NCT01560247|"     To determine the revascularization rate, clinical efficacy and safety of the CE-marked     MindFrame System in ischemic stroke patients   "
131771|NCT01560234|"     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics     of single ascending doses of AZD8848 in healthy subjects.   "
131772|NCT01560221|"     The combination of using injection drugs, smoking crack cocaine, having multiple sex     partners, and inconsistent condom use results in substantial risk for acquiring and     transmitting HIV, and many drug dependent adults who have been arrested on charges of     prostitution fit this profile. Existing interventions for reducing HIV risk have had limited     efficacy in drug-dependent sex workers, and criminal justice approaches have been ineffective     despite their high cost. A potentially ideal alternative is to divert drug-dependent     arrestees from prosecution to a treatment that reduces drug use and HIV sex risk behaviors,     while providing job skills training and promoting community employment to alleviate the     financial need to continue sex work. In order to provide an effective therapeutic alternative     to criminal prosecution, the investigators propose to develop a multifaceted intervention     that includes opiate agonist treatment (i.e., methadone OR buprenorphine) and the Therapeutic     Workplace. The Therapeutic Workplace is a supported environment in which participants are     required to provide drug-free urine samples to access paid job skills training or employment     and to maintain the maximum rate of pay. The overall intervention is designed to reduce drug     use and HIV risk behaviors, and simultaneously promote employment. The proposed project is a     2-year Stage I behavior therapy development effort that will include the development,     manualization and pilot testing of a Therapeutic Workplace intervention tailored to     drug-dependent adults arrested for prostitution. In the pilot study, the investigators will     recruit opiate- and cocaine-dependent adults arrested for prostitution from the Eastside     District Court in Baltimore. Eligible individuals will be offered methadone treatment in lieu     of prosecution and will be required to remain in methadone treatment for 90 days to have the     charges against them dropped. After enrolling in opiate agonist treatment, the diverted     individuals will be invited to participate in the pilot study. Interested individuals will be     randomly assigned to receive the standard opiate agonist treatment services or these services     plus the Therapeutic Workplace. The Therapeutic Workplace has two phases. In Phase 1,     participants will be offered four months of stipend-supported job training in the Therapeutic     Workplace. In Phase 2, participants will be encouraged to seek employment in a community job     and will receive wage subsidies for four months for maintaining community employment or     engaging in supervised job seeking. Throughout both phases, participants will be required to     provide drug-free urine samples to receive Therapeutic Workplace wages (training stipends in     Phase 1 and wage subsidies in Phase 2). The wage subsidy program will include drug testing     managed by a national supplier of drug-free workplace services. Overall, this treatment could     serve as a novel and ideal intervention for drug-dependent adults arrested for prostitution     while reducing criminal justice costs.   "
131773|NCT01560208|"     Corneal diseases are a major cause of blindness worldwide, and corneal infections are a     substantial cause of blindness in Asia. The aim of the Asia Cornea Society Infectious     Keratitis Study (ACSIKS) is to study infectious keratitis (corneal infections) in Asian     countries, so as to improve strategies for prevention and treatment, and to reduce the burden     of blindness in Asia.      The first phase of ACSIKS is an 18-month observational study involving 11 eye hospitals in 8     Asian countries; these hospitals manage more than 6700 cases of corneal infections every     year. From the first quarter of 2012, all patients with a corneal infection will be recruited     and a standard ACSIKS protocol will be applied; this protocol includes the use of a common     set of study forms and a suggested panel of microbiological examinations. However, each     centre will be continue to treat their patients with the anti-infective therapy standard for     their centre. Data will be recorded for each patient for a period of six months, including     their medical and surgical management, the final clinical outcome and vision.      Bacterial and fungal growths from patients will also be stored for further research during a     second phase of ACSIKS. These studies will focus on evaluating the resistance of the most     common bacterial infections to the current available antibiotics, performing DNA testing to     compare our strains with bacterial infections in the West, and to developing new diagnostic     tests and anti-infective therapies tailored to corneal infections in Asia.   "
131774|NCT01560195|"     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2     trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma     half-life, and prolonged efficacy in compare with ﬁlgrastim. The purpose of this study is to     determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia     following chemotherapy in patients with advanced NSCLC.   "
131775|NCT01560182|"     This is a phase I/II protocol aiming at the assessment of the safety and efficacy of ARSA     gene transfer into hematopoietic stem/progenitor cells for the treatment of Metachromatic     Leukodystrophy.   "
131778|NCT01560130|"     Behavioral weight loss programs can successfully reduce body weight, but these programs are     available to limited numbers of overweight and obese individuals. This project evaluates a     unique weight loss approach that combines a self-sustaining weight loss campaign (for     outreach) with training in behavioral weight loss strategies and tests the efficacy of adding     components designed to enhance accountability and increase motivation for weight loss.   "
131779|NCT01560117|"     Immunotherapy with the monoclonal anti-CD20 antibody rituximab has become standard of care     for patients with follicular lymphoma. However, there are still open questions regarding     dosing and scheduling of rituximab, optimal type of chemotherapeutic combination partners     during induction as well as the best interval and length of rituximab maintenance treatment.     Fludarabine-mitoxantrone combinations have shown strong debulking activity as initial therapy     followed by rituximab maintenance. While rituximab maintenance with a standard dose of 375     mg/m2 prolongs clinical remissions, administration schedules still vary: Three-monthly     infusions for 2 years and two-monthly infusions for one or 2 years are most frequently used.     A few pharmacokinetic data for rituximab have been reported for induction treatment. These     studies have proposed a presumptive active level of 25.000 ng/ml in anti-lymphoma     treatment. However, there is only limited information regarding maintenance treatment in     patients who are in remission and have no remaining tumor load.      The aim of this trial is to investigate the effect of treatment with oral Fludarabine,     Mitoxantrone und Rituximab and Rituximab maintenance on the depth of remission measured by     BCL2/IgH PCR.   "
131780|NCT01560104|"     A Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin     and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated     Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC).   "
131781|NCT01560091|"     Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown     to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new     alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific     receptors on the ureter. The investigators would like to see if there is some benefit to     taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to break     kidney stones in terms of allowing the ureteral fragments to pass through the ureter. Our     hypothesis is that silodosin will be at least as effective as tamsulosin in terms of allowing     stones to pass, but may allow them to pass more quickly because of the rapid onset of action.      The side effect profile for both drugs is quite similar and tolerable. Patients may     experience some common side effects associated with tamsulosin, including abnormal     ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness). Serious     reactions include orthostatic hypotension, syncope (fainting), and priapism (prolonged     undesired erection).      Patients may experience some common side effects with both silodosin and tamsulosin including     ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache. Serious     side effects are rare and include orthostatic hypotension, intra-operative floppy iris     syndrome, syncope, and priapism.      Patients will experience the discomfort normally associated with kidney stones. All efforts     will be made to alleviate these discomforts, including the use of the study medications.     Patients will be able to take their routine prescribed pain medications, and will be asked to     keep a record of their pain medication use.      The investigators will be randomly enrolling patients from all racial backgrounds and of both     genders. They must have kidney stones ranging in size from 4mm to 1.0 cm and have no prior     treatment for the study.      The primary endpoint of this study is the clearance rate of kidney stones. That is, in what     period of time does the patient achieve clearance, is stone free and has all residual stones     gone. The secondary endpoints of this study include analgesic use, residual stones remaining,     need for re-treatment, need for intervention, steinstrasse clearance, and the need for     hospitalization.   "
131782|NCT01560078|"     Tubercular pleural effusion is the second most common form of extrapulmonary tuberculosis     (EPTB) seen in clinical practice after tuberculosis (TB) lymphadenitis. It is common that     after complete treatment of the patient with tubercular pleural effusion with six months of     the short-course chemotherapy under Directly Observed Treatment Short-Course (DOTS), pleural     effusion has not resolved completely. In these cases treatment need to be extended for one or     two more months by giving extension pouches.      Since DOTS does not recommend demonstration of complete resolution of tubercular pleural     effusion at the end of treatment completion, there is paucity of data in terms of the     patients declared cure for the sputum negative pulmonary and extra-pulmonary TB as such which     includes TB pleural effusion as well. This project aims to look into the patient     characteristics, treatment outcome, and compute the number of cases which require an extended     regimen and to what extent is the pleural effusion persistent at the end of six months of     standard DOTS therapy.   "
131783|NCT01560065|"     Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates     (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules     is higher than in serum and it was increasing during the movement through the epididymis and     the deferent duct. In the present study, the role of myo-inositol has been investigated as a     possible antioxidant agent for the systemic treatment of male infertility and the improvement     of the sperm's quality.      Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle:     healthy subjects and subjects with oligoasthenospermia (OA, < 15 mil/ml). The collected     samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's     number and motility, during the initial semen analysis and after density gradient separation     method; these parameters were evaluated before and after the administration of 4000mg/die of     myo-inositol associated to 400 µg of folic acid for three months.      These values were compared with samples of seminal fluid of healthy patients undergoing to a     IVF cycle for a female cause of infertility (control group).   "
131784|NCT01560052|"     This study will evaluate the long-term efficacy and safety of low dose oral     methylprednisolone compared to matching placebo, on a background of routine RAS inhibitor     therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting     a high risk of progression.   "
131805|NCT01559779|"     The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric     bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as     well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric     procedure that changes the gastrointestinal anatomy and has been demonstrated to cause     remission of type 2 diabetes shortly after the operation, before any significant weight loss.     The altered transit of nutrient through the gastrointestinal tract after the operation is     thought to play a key role in this remission and studies have shown significant changes in     the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1).     However it is unknown whether the secretory function of the pancreatic islets as well as the     stimulatory effect of the incretin hormones is changes postoperatively.   "
132335|NCT01552824|"     There are two options of fetal treatment in cases of severe lower urinary tract obstructions:     the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the     effectiveness of these treatment, specially comparing both techniques. The present study aims     to investigate the effectiveness of these treatments.   "
131785|NCT01560039|"     Chronic neuropathic pain is a global health concern, affecting millions of patients     worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic     challenge. The current mainstay of treatment is pharmacotherapy consisting of powerful     analgesics combined with different classes of drugs that change nerve cell membrane     properties. However, response to pharmacotherapy is often poor and mandates interventional     strategies. Among the latest and most promising interventional strategies is the use of     neurostimulation to targeted brain areas, specifically the primary motor cortex . Motor     cortex stimulation , both invasive and noninvasive (using megnetic or electical stimulation),     has emerged as a highly beneficial treatment, and is currently included in different     professional guidelines for the treatment of medically refractory neuropathic pain.      A possible alternative way to achieve stimulation of the motor cortex is by using EEG based     neurofeedback. This design, which is actually a Brain Computer Interface (BCI) enables the     patient to voluntarily modulate the activity of a circumscribed brain area after a few     training sessions. While EEG based neurofeedfback is decades old, it has never been tested in     neuropathic pain patients.      This experiment is intended to compare both the clinical effects and the brain correlates of     a BCI based self modulation of M1 activity and of exogenous magnetic brain stimulation in a     population of patients suffering from chronic neuropathic pain of an upper limb. 15 such     patients will receive a course of 10 daily magnetic stimulation sessions with stimulation of     M1 as described in the literature. A further 30 patients will be divided into two groups: 15     will perform a course of 10 real BCI neurofeedback sessions modulating motor cortex activity     and 15 will perform a course of 10 sham neurofeedback sessions. The participants' baseline     chronic pain levels and their response to acute painful stimuli will be clinically evaluated     before and after the course, and for an additional 1 month. Furthermore, before and after the     course patients will be scanned using functional MRI during rest (baseline pain levels) and     during acute pain. These scans are performed both to describe the neural correlates of the     analgesia induced by motor cortex magnetic stimulation , and to compare the observed networks     to the network effect of a BCI neurofeedback modulation of motor cortex activity.   "
131786|NCT01560026|"     Endometrial cancer is one of the most common female malignancies in the United States, and     has increased in incidence in Taiwan in recent decades.A recent population-based analysis     noted that 4% of endometrial cancers occurred in women aged 40 years or younger, furthermore     it is up to 15% in Taiwan according to the data of cancer registry. The standard treatment of     endometrial cancer results in surgical menopause and places patients at risk for the     long-term sequelae of estrogen deprivation. The goal of this study was to determine the     frequency of a coexisting ovarian malignancy and to evaluate the outcome of ovarian     preservation in women with treatment for endometrial cancer.   "
131787|NCT01560013|"     Alcohol dependence is a major health problem worldwide and recently in Israel and it has     major health care costs. Cannabis dependence is also a major health issue and many cannabis     users find it difficult to quit. Similar to dependence on heavy drugs, alcohol and     cannabis-dependent patients find it difficult to quit drinking and smoking cannabis and they     relapse to drinking alcohol and using cannabis during treatment. Craving for alcohol and     cannabis and withdrawal during detoxification are major factors for relapse to drinking and     using cannabis. The cue-exposure and priming paradigms have been used in order to induce     craving for alcohol and cannabis in the laboratory. Several studies have delineated the brain     mechanisms responsible for cue-induced craving for alcohol using functional Magnetic     Resonance Imaging (fMRI), a method that can be useful in monitoring progress of treatment. A     proven useful medication for treatment of alcohol dependence is the opiate antagonist     naltrexone commonly used for treatment of opiate dependence. We have found that     cannabis-dependent patients in treatment for cannabis dependence who also were heavy users of     alcohol have dropped early from treatment.   "
131788|NCT01560000|"     The objective of this study is to determine the satiety value of different bran fibers on     appetite & subsequent food intake with acute consumption. Satiety will be measured     subjectively by visual analogue scales (VAS).   "
131789|NCT01559987|"     The purpose of this research study is to investigate water flow in dental devices and to     understand the function of water flow behind oral hygiene improvements. Understanding this     mechanism may help with the design of future products.   "
131790|NCT01559974|"     The purpose of this study is to determine whether the intake of Vitamin D has a positive     effect on walking ability of patients with peripheral artery occlusive disease. Skeletal     muscle fibers change morphology in peripheral artery occlusive disease. In patients with     Vitamin D-deficiency there are also changes of skeletal muscle fibers. The investigators have     the hypothesis that patients with peripheral artery occlusive disease with subsequent changes     of muscle fibers morphology of calf muscles might take profit of the administration of     Vitamin D in combination with training.   "
131791|NCT01559961|"     The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in     women with interstitial cystitis/bladder pain syndrome.   "
131792|NCT01559948|"     The purpose of this randomized clinical trial is to examine the usefulness of the addition of     a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac     joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to     lumbopelvic stabilization exercises alone. Outcome measures including the Modified Oswestry     Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness     (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric     Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement     using the Global Rating of Change (GROC) scale will be collected. Hypothesis: The OSW scores     and NPRS scores will be lower for those who receive the compression belt in addition to the     lumbopelvic stabilization program as compared to those who receive the lumbopelvic     stabilization alone. The percent change of muscle thickness for the deep abdominals as well     as the GROC scores will be higher for those who receive the compression belt in addition to     the lumbopelvic stabilization program as compared to those who receive the lumbopelvic     stabilization alone.   "
131793|NCT01559935|"     The purpose of this study is to evaluate the safety and effectiveness of an investigational     new drug called carfilzomib, in combination with dexamethasone in subjects with newly     diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin     (Biaxin®), lenalidomide (Revlimid®) and dexamethasone (Decadron®) [BiRD] then lenalidomide     alone.   "
131794|NCT01559922|"     The purpose of this study is to determine whether Artefill is safe and effective for the     correction of atrophic facial acne scars.   "
131817|NCT01559623|"     The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma     urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder     symptoms, and to correlate these findings with cystoscopic and urodynamic findings.   "
131818|NCT01559610|"     The purpose of this study is to determine whether the guidelines preoperative performed by a     nurse contribute to the recovery of the patient submitted to cardiac surgery compared with     the guidelines for routine.   "
131795|NCT01559909|"     Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a     socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb.     VAS may improve stability, weight bearing, comfort, proprioception, limb health, and     function. To date, there is no evidence to support whether VAS alters balance, kinematics,     and kinetics when walking for TF amputees as compared to conventional socket suspension     technology. Further, there is question regarding what the optimal height of the socket should     be to maintain stability and function. So long as stability is not sacrificed, it may be     advantageous to lower the height of the socket to allow full hip motion and improve sitting     comfort. The purpose of this investigation is to assess if the socket height alters the     motion of the leg and changes the way one walks when using VAS compared to conventional     socket suspension technology. In this study, TF amputees will be fitted with a VAS socket     that will be attached to their current prosthesis using similar alignment. Individuals will     be assessed while walking on a level floor and during stair negotiation while wearing the     prosthesis with the VAS socket at various socket heights as well as their current socket.     Additionally, balance and socket standing and sitting comfort will be investigated.   "
131796|NCT01559896|"     The incidence of type 2 diabetes mellitus (T2DM) is rapidly growing. Patients with T2DM are     at increased risk of developing long term micro- and macrovascular complications. Subjects     with impaired glucose tolerance (IGT) show increased blood glucose levels after an oral     glucose load. These subjects have a markedly increased risk of later T2DM development.      T2DM development can be prevented or delayed by lifestyle modifications. To support lifestyle     changes and reduce the risk of T2DM development, foods containing functional ingredients are     being developed. An interesting functional ingredient is protein hydrolysate. An egg protein     hydrolysate has been experimentally shown to improve endothelial function, to inhibit plasma     angiotensin converting enzyme (ACE) and to reduce blood pressure in rats. Egg protein     hydrolysate could thus be a interesting ingredient to treat the cardiovascular dysfunction     associated with T2DM. In the present study, the effects of egg protein hydrolysate will be     evaluated in subjects with overweight or moderate obesity and IGT or T2DM.   "
131797|NCT01559883|"     The study aims to document the flow of German patients with cancer and acute deep vein     thrombosis from first visit to diagnosis and treatment, the applied diagnostic procedures,     and therapy modalities.   "
131798|NCT01559870|"     The purpose of this study is to create a model using intra-operative modified SOFA score and     peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit     (CICU) for adult cardiac surgery with heart-lung machine   "
131799|NCT01559857|"     The purpose of this study is to see how an insulin sensitizing medication, Pioglitazone, can     cause changes in mood in some depressed patients. Study participants receive assessment of     their cognitive and metabolic functioning.      If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a     90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting     insulin and glucose levels, as well as routine blood testing.      The investigators hope to quantify the role of Pioglitazone in patients with mood disorders     and compare the values to those previously obtained in a healthy age-matched control     population. The investigators also hope to examine the association between IR and cognitive     performance and clinical course of depression in patients with mood disorders.   "
131800|NCT01559844|"     The primary objective is to determine if the administration of a combination of sofosbuvir     (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular     carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could     prevent post-transplant re-infection as determined by a sustained post-transplant virological     response (HCV RNA < LLoQ) at 12 weeks post-transplant.      Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants     enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to     an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48     weeks in the pretransplant treatment will have a second baseline at Week 24 for combined     analysis in the pretransplant retreatment phase.      Participants who undergo liver transplant will stop all study drug 24 hours prior to     transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.   "
131801|NCT01559831|"     IC51-319 is a single-arm, open-label study that investigates immune responses in subjects     undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during     primary immunization.   "
131802|NCT01559818|"     Patients who were previously enrolled in Study IMM-101-001 and who provide informed consent     will be eligible to participate in this study.      Once eligibility is confirmed, a full medical history covering the period from their     completion of Study IMM-101-001 to date will be taken.      The treatment regimen with IMM-101 will be one dose given every 4 weeks or as close to this     interval as permitted due to practical or logistic considerations. The dose interval may be     modified at the discretion of the Investigator provided the minimum period between doses in     no less than 14 days.      The overall objective is to determine the long term safety profile of IMM-101 administered     intradermally for extended use.   "
131803|NCT01559805|"     The study involves delivering one of two interventions - either Promoting Action Towards     Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men     (MSM) who have recently been diagnosed with HIV and assessing whether participants who     received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of     care and adherence to treatment, and engage in less sexual HIV transmission risk behavior     than participants who received PCC.        -  PATH consists of two preliminary sessions plus booster sessions after 1, 3, and 6          months.        -  Personalized Cognitive Counseling consists of one session.      Participants will complete assessments before participating in their intervention (i.e., at     baseline) and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be     measured at approximately 6 and 12 months following baseline.   "
131804|NCT01559792|"     The investigators want to study the changes in secretion of gastrointestinal hormones,     absorption and metabolism of food and liquids before and after gastric bypass and in patients     who are gastric banded but are getting conversion to a gastric bypass. All patients are with     normal glucose tolerance. The investigators hypothesis that food uptake/absorption of food is     faster after gastric bypass and the secretion of gastrointestinal hormones change.   "
131806|NCT01559766|"     Vitamin A deficiency remains a major public health problem in developing country worldwide.     Young Children are considered to be at greatest risk of deficiency. However, there is little     information on the vitamin A requirement of Chinese children. In the present study, about 400     children aged between 4 and 9 years old in a kindergarten and an elementary school of Shiyan     City were screened before admission by questionnaire and anthropometric measurement. The     vitamin A status of children was assessed by serum vitamin A level, relative dosage reaction     and stable-isotope dilution technique. At the same time, their dietary vitamin A intakes were     estimated by weighted-food dietary survey. The dietary vitamin A requirement in young     children was determined on the basis of dietary vitamin A intakes in Children with adequate     vitamin A level.   "
131807|NCT01559753|"     The duration of treatment of community acquired pulmonary infection varies between 5 and 14     days according to the authors (22), or even 3 days with new drugs having long half-life (2).     For nosocomial pulmonary infection, treatment durations are not standardized (5). It is     simply mentioned the concept of usual treatment of at least 15 days. However, recent     studies used 10 days of treatment without significant decrease in the rate of healing     compared to usual treatment. It is essential to clarify the optimal duration of antibiotic     treatment. Indeed, any excessive extension of treatment may increase the occurrence of     adverse effects (renal toxicities, hepatic...), and induce resistance of bacteria to     antibiotics (selection pressure), colonization of the patient by Multiresistant bacteria and     an increase in the cost of treatment   "
131808|NCT01559740|"     After undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may     experience some amount of pain in the post-operative period. As part of the anesthesia     technique, the investigators routinely provide a nerve block done on the abdominal wall that     will provide pain relief for at least 10 hours postoperatively. This is referred to as a TAP     block. The purpose of this study is to determine if the nerve block performed with local     anesthetic solution using a regular concentration solution vs. a diluted solution may offer     different durations of pain relief.   "
131809|NCT01559727|"     The purpose of this study is to examine the efficacy of three doses of prednisone, a     glucocorticoid, in treatment of patients with symptomatic heart failure.   "
131810|NCT01559714|"     Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical     Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical     HCM).      Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and     pre-clinical HCM patients.   "
131811|NCT01559701|"     Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low     Back Pain Or Osteoarthritis   "
131812|NCT01559688|"     Service members and veterans often experience symptoms of psychological trauma following     combat deployments. While efforts are being made in the military and at the Veteran's Affairs     to meet the large number of soldiers and veterans experiencing symptoms of psychological     trauma, there remains a need to evaluate new treatments, particularly those that are designed     to be brief in length.      A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological     therapy that is designed for rapid resolution of symptoms of psychological trauma. This     approach uses a combination of talking and sets of eye movements guided by the therapist.     During therapy, this interactive personal guidance is thought to be helpful in resolving     problems (such as bad memories).      The purpose of this study is to:        1. Evaluate how effective ART is in treating symptoms of psychological trauma among          non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring          Freedom in Iraq and in Afghanistan or other combat conflicts.        2. Learn if there is improvement in symptoms of psychological trauma (such as bad memories,          anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).   "
131813|NCT01559675|"     The purpose of this study is to evaluate the effect of low dose versus high dose steroids     vital signs of patients currently on steroids or recently treated with steroids undergoing     major colorectal surgery. The investigators hypothesize that there will be no statistically     significant difference in orthostatic hypotension (blood pressure measured on lying, sitting,     and standing), blood pressure, temperature or heart rate in the standard and low dose groups.   "
131814|NCT01559662|"     The Purpose of this study is to evaluate the effect of gum chewing on recovery of     gastrointestinal function in patient undergoing major colorectal surgery. The investigators     hypothesize that patients who chew gum after major colorectal surgery will have faster     recovery of gastrointestinal function.   "
131815|NCT01559649|"     Stroke is a major medical problem in the United States, and veterans are at significant risk     given that the most critical risk factors of stroke, older age and associated medical     problems such as high blood pressure, are common. Dysphagia, swallowing problems, can lead to     aspiration which in turn may result increased pneumonia, particularly in stroke patients.     Development and implementation of an accurate and consistent nursing swallowing screening     tool to identify risk of aspiration in individuals admitted with suspected stroke is critical     as it allows for immediate intervention, thereby reducing associated medical complications,     length of stay, and healthcare costs. The availability of such screening tools, however, is     limited. The primary objective of this study is to construct a reliable and valid swallowing     screening tool to identify risk of aspiration in individuals admitted with suspected stroke.   "
131816|NCT01559636|"     Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been     eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate     eradication. One concern in this effort is that some populations have decreased     immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased     seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV)     was recommended for use in immunization campaigns, and will likely replace tOPV in routine     immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been     studied.      This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who     reside in Nepal. The investigators conducted a prospective, interventional study that     assessed immune response to bOPV among infants with and without diarrhea. Immune responses     were compared among infants with and without diarrhea.      This study will result in a better understanding of the factors that decrease the ability of     some children to seroconvert to OPV and be protected from poliomyelitis infection.   "
131819|NCT01559597|"     The purpose of this study is to determine the effectiveness, safety and feasibility of a     tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a     controlled temperature chain (CTC). The CTC is defined as the storage and transport of     vaccines within a temperature range appropriate to the heat stability profile of TT vaccine.     In this study vaccines are transported and stored in the cold chain up to district level.     From district to beneficiary level vaccines are exposed to ambient temperatures during a     limited period of time.      In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For     this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in     the laboratory and compared to vaccines that have been maintained in cold chain. If all     parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the     strategy in CTC will be used.      Only if the laboratory results are adequate, villages will be assigned to one of the     vaccination strategies. All women between 14 to 49 years of age in the selected villages who     fulfill the inclusion criteria will be invited to participate.      In order to determine the baseline anti-tetanus protection, TT vaccination history will be     collected from all participants using a standardized questionnaire. Women who have already     received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood will     be collected from all participants to later verify in laboratory the baseline protection.      A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold     chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the     same strategy employed for the first dose. Finally, four weeks after the second dose, a blood     sample will be collected from all participants who received two doses of vaccine. The     serological responses will be compared in the group that received two doses of TT vaccine     maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.   "
131820|NCT01559584|"     Alopecia areata (AA) is a disease of the hair follicles with multifactorial etiology and a     strong component of autoimmune origin. It is characterized by non-scarring hair loss on the     scalp or any hair-bearing surface.      Various therapeutic agents have been described for the treatment of AA, but none are curative     or preventive. The aim of AA treatment is to suppress the activity of the disease.     Phototherapy in the form of topical psoralen and ultraviolet A (PUVA) has been a well     documented therapy for AA since 1978.      A more recent technique of topical PUVA, namely phototoxic PUVA, has been adopted in two     previous studies. Sessions were carried out once every 3 months, and a higher efficacy with     more encouraging response rates in comparison to the conventional PUVA therapy has been     documented. This assumed upper hand over the conventional PUVA might be due to increasing the     amount of UV reaching the hair follicle cells and the surrounding inflammatory cells. Also it     has been suggested that it might play a role as a powerful initiating agent of suppression     through direct action at the DNA level. However, still the exact effect of this treatment has     not been fully clarified.   "
131821|NCT01559571|"     The purpose of this study is to determine what factors influence the visual outcomes of     infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.   "
131822|NCT01559558|"     The purpose of this study is to retrospectively review the impact of vaginal packing on the     urodynamic studies, especially for urethral pressure profiles.   "
131823|NCT01559545|"     Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly     in people who have taken potent antibiotics. When C. difficile multiplies within the colon,     it produces two toxins that cause inflammation and resultant abdominal pain, fever and     diarrhea. Current treatment of mild to moderate disease is with immediate release     metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed     a delayed release form of metronidazole to release just before the colon to increase the     concentration of antibiotic in the colon to improve the effectiveness of metronidazole     treatment and potentially to allow less whole body exposure to the antibiotic.      This study will measure the amount of metronidazole in the blood and stool of patients with     C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing     the antibiotic as designed, immediately before the colon.   "
131824|NCT01559532|"     This is an observational study to analyze the influence of surgery duration and tourniquet     time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total     knee arthroplasty (TKA).   "
131825|NCT01559519|"     The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post     tips hepatic encephalopathy'   "
131826|NCT01559506|"     The objective of this study is to determine whether the Air Barrier System (ABS) reduces     airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior     spinal procedures   "
131827|NCT01559493|"     Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of     coronary artery stenosis severity in routine practice        -  To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous          coronary intervention (PCI).        -  To investigate the influence of hyperemia on iFR.        -  To test reproducibility of iFR and FFR.   "
131828|NCT01559480|"     Endometriosis is one of the most common disease in reproductive aged women.Surgical     intervention has a significant symptoms relief. However, symptom recurrence is often after     surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in     pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary     outcome measurement is pain score at 6 months after surgery.   "
131829|NCT01559467|"     Approximately half of patients with acute chest pain, a very common reason for emergency     department visits worldwide, have a cardiac cause. Two-thirds of patients with a cardiac     cause are eventually diagnosed with a so-called non-ST-elevation myocardial infarction. The     diagnosis of non-ST-elevation myocardial infarction is based on a combination of symptoms,     electrocardiographic changes, and increased serum cardiac specific biomarkers (high-sensitive     troponin T). Although being very sensitive of myocardial injury, increased high-sensitive     troponin T levels are not specific for myocardial infarction. Invasive coronary angiography     is still the reference standard for coronary imaging in suspected non-ST-elevation myocardial     infarction. This study investigates whether non-invasive imaging early in the diagnostic     process (computed tomography angiography (CTA) or cardiovascular magnetic resonance imaging     (CMR)) can prevent unnecessary invasive coronary angiography. For this, patients will be     randomly assigned to either one of three strategies: 1) routine clinical care and computed     tomography angiography early in the diagnostic process, 2) routine clinical care and     cardiovascular magnetic resonance imaging early in the diagnostic process, or 3) routine     clinical care without non-invasive imaging early in the diagnostic process.   "
131830|NCT01559454|"     Chronic pain patients are treated with prescription opioids and many exhibit opioid     addiction. Currently, there are no evidence-based guidelines to better manage patients with     chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and     methadone treatment in these patients. The investigators hypothesize that both buprenorphine     and methadone treatment will reduce pain and addiction behaviors and increase functioning in     these patients.   "
131831|NCT01559441|"     Increased postprandial lipemia may increase the risk for cardiovascular diseases. An     important mechanistic link between lipemia following a high-fat meal and adverse     cardiovascular events is lipid-mediated endothelial activation. Therefore, it is important to     identify nutrients that can neutralize this acute vascular disturbance.      The investigators hypothesize that beetroot juice, a food rich in inorganic nitrate, could     improve vascular activity during the postprandial phase.   "
131832|NCT01559428|"     Plant sterols and stanols (also called phytosterols and phytostanols) are structurally     related to cholesterol, but absorbed to a much lesser extent. Due to this structural     similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower     serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol-     and stanol-enriched food products are therefore widely available on the market to lower the     risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the     formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are     atherogenic. Although oxyphytosterols have been identified in human serum samples, the effect     of an increased intake of plant sterols on serum oxyphytosterol concentrations in humans is     not known. On the other hand, plant stanols cannot be oxidized and lower not only cholesterol     absorption, but also plant sterol absorption.      The major objective of the present study is to examine the effects of dietary plant sterols     and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to     investigate the effects of these products on postprandial serum oxyphytosterol     concentrations.   "
131833|NCT01559415|"     Almost half of the Dutch population is currently characterized by overweight and obesity.     Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight     regain after weight loss: the yoyo-effect. The primary objective of this study is to     investigate the association between the weight-loss-induced cellular stress response and the     rate of weight regain. The secondary objective is to investigate the differences in cellular     stress response and weight regain after rapid and slow weight loss. To investigate this,     subjects will receive meal replacements replacing either all or part of the daily meals     during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks     while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week     normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up     period subjects will receive dietary advice according to the Dutch recommendations for     healthy eating. The association between the amount of weight regain after the weight loss     period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue     metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein     expression and gene polymorphisms in selected genes.   "
131834|NCT01559402|"     The study investigates if applying a special ventilatory strategy during anesthesia for     laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of     using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates     oxygenation with blood gas samples but also with a new method that might give more     information without the use of blood gas samples.      Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction     and maintenance of anesthesia is performed with either a continuous positive airway pressure     (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in     comparison to a technique without CPAP but with a PEEP of 10 cm H2O.      Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative     period if emergence from anesthesia is performed without high levels of oxygen.   "
131835|NCT01559389|"     Study the quality of the relationship in couples affected by Urge Urinary Incontinence (UUI)     and identify how treatment may improve the relationship.   "
131836|NCT01559376|"     The objectives of the study are two-fold:        1. To determine the mean 5 year patency rate of the radial artery graft (Open vs.          Endoscopic) of patients who have already had CABG surgery and who previously          participated in the centre's RCT back in 2005-2007 using CTA and MPS-MIBI        2. To determine patient quality of life at 5 years post CABG surgery      It is hypothesized that the mean 5 year patency rate of the radial artery graft harvested     endoscopically will be equal to or have greater patency than the radial artery graft     harvested via the conventional/open technique. It is further hypothesized that patient     quality of life will be similar amongst patients having had the open vs. endoscopic radial     artery graft during CABG surgery.   "
131837|NCT01559363|"     The primary objective of this study is to determine the safety, plasma pharmacokinetics, and     maximum tolerated dose (MTD) of KD019 when administered to subjects with ADPKD.   "
131838|NCT01559350|"     The ideal grafts for the right coronary artery system in coronary artery bypass surgery     remain controversial. The objective of this study is to compare the long-term patency of a     right gastroepiploic artery and a saphenous vein graft used for revascularization of the     right coronary artery system in off pump coronary artery bypass surgery and to analyze the     long-term clinical outcomes.      Total 224 patients will be enrolled according to the randomization protocol.      Check list        1. Laboratories        2. Quantitative coronary analysis (preoperative)        3. Major adverse cardiac and cerebrovascular event        4. coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years          postoperatively        5. Echocardiogram      5. Cardiac enzyme   "
131839|NCT01559337|"     A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger     pulp, which results in functional disability.The dorsal branch of the PDN can be transferred     for reconstruction of such nerve defects.In this study, the investigators modified the     Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for PDN     defects. For comparison, the investigators collected a consecutive series of 32 patients with     finger PDN defects treated using a traditional sural nerve graft from February 2005 to     October 2008.   "
131856|NCT01559116|"     The primary objective of the trial is to determine the 24-hour FEV1-time profile of     tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of     treatment.   "
131857|NCT01559103|"     Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients   "
131858|NCT01559090|"     The purpose of this study is to assess safety, tolerability, pharmacokinetics and     pharmacodynamics of MEDI-546 in Japanese SLE patients.   "
131840|NCT01559324|"     ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years.     There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU)     and bifrontal (BF) electrode positions, the placements that are considered safe for the     elderly. As far as the investigators know no randomized controlled trials (RCTs) have yet     been published describing this population treated with BF or RU ECT. Non-demented depressed     patients will be randomized to either method (n = 2x36). Symptom intensity, global cognitive     function and biomarkers will be related to 20 healthy comparators. Testing, evaluation of     depression and blood-tests are done before ECT-treatment, after a series of 6-16 ECT and 3     months after terminated ECT-treatment.   "
131841|NCT01559311|"     The purpose of this clinical project is to evaluate the efficacy of the presence of Right     Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for     bi-ventricular pacing in patients with bradycardia and normal left ventricular ejection     fraction (LVEF). The results of this project may provide with the evidence based medicine for     guidelines expansion of using Cardiac resynchronization therapy (CRT) in patients with Heart     Block and normal LVEF (LVEF >45%).   "
131842|NCT01559298|"     The purpose of this study is to compare aspirin + clopidogrel with aspirin alone as     antithrombotic treatment following transcatheter aortic valve implantation (TAVI) for the     prevention of major ischemic events [myocardial infarction (MI), ischemic stroke] or death     without increasing the risk of major bleeding events.   "
131843|NCT01559285|"     In this trial, the investigators intend to examine whether the concentration of local     anesthetics during epidural analgesia could be modulating factor for change of hemodynamics     in patients undergoing major upper abdominal surgery.   "
131844|NCT01559272|"     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a     paliperidone palmitate 3-month formulation in patients with schizophrenia.   "
131845|NCT01559259|"     This study will determine the overall analgesic efficacy of three different fixed dose     ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.   "
131846|NCT01559246|"     The purpose of this study is to compare short term (up to 48 hours) traditional cardiac     rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14     days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA     (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected     cardiac arrhythmias.   "
131847|NCT01559233|"     Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment     procedures has grown dramatically over the past decade as new treatments and technologies     have been introduced.      This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus     System, an innovative noninvasive system intended for wrinkles and rhytides treatment.      Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months     after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos     were introduced to three uninvolved physicians for blinded evaluation.   "
131848|NCT01559220|"     The purpose of this clinical study is to investigate the safety and efficacy of deep brain     stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and     functional disability of Alzheimer's disease.   "
131849|NCT01559207|"     The main objective of this study is to evaluate, for 15 healthy volunteers and for 15     patients with a history of venous thromboembolism (VTE), the monthly variation (over 6     months) of plasma nucleosome and free DNA concentrations.   "
131850|NCT01559194|"     The primary specific aim of this study was to determine if overweight and obese premenopausal     women can lose weight and if long term weight loss impacts biomarkers associated with breast     cancer risk.   "
131851|NCT01559181|"     There is an increasing trend in the society for developing obesity, type 2 diabetes and     cardiovascular diseases. It is therefore important to identify the risk factors behind this     tendency. Recent studies have shown that exposure to high blood sugar levels in pregnancy (as     in mothers with type 1 diabetes) may play a role in the development of obesity, type 2     diabetes and cardiovascular diseases later in life for the children. Some studies suggest     that high blood sugar levels during pregnancy can also affects cognitive function as well as     growth and development of puberty. The mechanisms behind this are not sufficiently clarified     yet.      In the period 1993-1999, pregnant women with type 1 diabetes in Denmark were followed and     information about the course of pregnancy was collected, including the long-term blood sugar     level during pregnancy and the children's' condition at birth. The unique opportunities in     Denmark to identify and follow the children of these mothers and the possibility to select a     comparison group of children of non-diabetic mothers gives a unique opportunity to examine     the children of mothers with type 1 diabetes and accurately investigate the effect of blood     sugar levels in pregnancy on conditions later in life.      There has not previously been made any study of this size and it is the investigators hope to     be able to quantify the effect of blood sugar level during pregnancy on outcomes later in     life. This will potentially give the possibility to detect individuals at risk for     cardiovascular diseases earlier and to improve prevention targets in children of mothers with     diabetes.   "
131852|NCT01559168|"     The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh     over a 12 month follow up period, using a composite outcome including a good anatomical     correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge)     symptoms (answer no at question 3 of the PFDI-20) and no reintervention for recurrent     prolapse of the anterior or apical compartment.   "
131853|NCT01559155|"     The primary objective of this study is to describe and compare plasmatic anti-proteasome     auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous     pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an     elderly control group.   "
131854|NCT01559142|"     The aim of the study is confirmation of efficacy of induction therapy with three doses of     infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and     safety of two regiment of maintenance therapy:        1. Infliximab with immunomodulation        2. Infliximab alone   "
131855|NCT01559129|"     The purpose of this first study is to evaluate the safety, tolerability, pharmacokinetics,     pharmacodynamics and efficacy of pomalidomide (CC-4047) in the treatment of subjects with     systemic sclerosis with interstitial lung disease.   "
131863|NCT01559025|"     The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the     prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus     newly diagnosis ( less than 6 months).      The secondary objectives are:        1. To define the immune and inflammatory profile        2. To define the secretion of glucagon and GLP-1        3. To assess the glycemic variability   "
131864|NCT01559012|"     CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the     effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis     Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover     design.   "
131865|NCT01558999|"     The purpose of this study is to assess the safety and effectiveness of SI-614 solution     compared with placebo solution in treating patients with dry eye   "
131866|NCT01558986|"     This is a randomized, double blinded, placebo-controlled trial on the routine use of     preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy     of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI)     in patients undergoing modified radical mastectomy (MRM) for breast care.   "
131867|NCT01558973|"     The purpose of this study is to explore whether frontal brain activation in response to     stress varies as a function of the presence or extent of early trauma and whether or not this     effect is greater in women compared to men. To examine the effect of stress on thinking and     remembering. To examine the separate and interactive effects of stress, addiction,     withdrawal, and genetics; and to examine fMRI brain activation associated with stressful,     reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video     clips in addicted individuals and in healthy controls.   "
131868|NCT01558960|"     Retinoblastoma treatment has become more and more focused in the last years. New treatments     developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.      Intra-arterial chemotherapy with Melphalan has shown success in some patients but with     limited response when there is marked vitreal seeding. For these cases Intravitreal     injections of Melphalan have been successful in Japan.      In this study the same chemotherapy (melphalan) will be administered intravitreally (directly     through the eye wall) and the response (short and long term) will be monitored.   "
131869|NCT01558947|"     The purpose of this study is to evaluate the safety and the effect of perioperative     chemotherapy in the treatment of advanced gastric cancer.   "
131870|NCT01558934|"     The primary objective of this study is to assess QTc (an interval of the heart rhythm)     interaction effects between lofexidine and methadone. The secondary objectives of the study     are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring     pharmacokinetics (amounts of drug in the blood), vital signs (heart rate and blood pressure)     and adverse events (side effects) when co-administered with methadone; and to describe     effects on opiate withdrawal when lofexidine is introduced following a 50% or 100% methadone     dose reduction, as required to elicit a withdrawal response. The investigators hypothesize     that while both agents are known to prolong the QTc interval, the combination of the drugs     will not create an additive effect which creates a significant safety concern. The     investigators further hypothesize that subjects will be able to tolerate the therapeutic dose     of lofexidine (0.8 mg four times daily) when the methadone maintenance dose is lowered to     elicit withdrawal.   "
131871|NCT01558921|"     Currently the 3-year disease free survival of patients with locally advanced rectal cancer is     about 50%. Current standard treatment for patients at high risk of failing locally and/or     systemically includes pre-operative long course radiotherapy (5 weeks) in combination with     chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has     been demonstrated to improve local control, but had no effect on the overall survival.     Different studies in patients with rectal cancer studying the effect of adjuvant post     operative chemotherapy did not result in an improved survival. This may be due the fact that     rectal cancer surgery (TME) is associated with a high complication rate so substantial     proportion of patients cannot receive chemotherapy postoperatively. An alternative approach     is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor     short-course radiotherapy (5 days) is given, as different studies showed local control of the     tumor for a long time. During this waiting period the patient is in a good condition to     receive an optimal dose of chemotherapy. The investigators hypothesize that with this     proposed protocol both the local tumour and possible micrometastases are effectively treated     and that this will result in an increased survival. The investigators will compare this with     the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional     adjuvant chemotherapy.   "
131872|NCT01558908|"     This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial     Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible     for surgical or catheter-based interventions. Three doses of ERC will be examined. The     hypothesis is that ERC administration will be well-tolerated and possibly induce a     therapeutic benefit.   "
131873|NCT01558895|"     The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat     treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of     the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the     treatment. Clinical symptoms were also observed simultaneously.   "
131874|NCT01558882|"     The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo     implantation. They are at the origin of the local secretion of cytokines, growth factors,     chemokines affecting vascular development and the local immunotrophisme for the conceptus.     The main objective of this study is to evaluate the expression of endometrial uNK cells     before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of     various cytokines and growth factors will also be studied.   "
131875|NCT01558869|"     This is an open-label, single centre, single-arm phase II study which aims to assess the     efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan     (Xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma.     Clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and     analyzed in this study. The patients' data will be collected and maintained in the Division     of Medical Oncology of the University Department of Medicine, Queen Mary Hospital, Hong Kong.   "
131876|NCT01558856|"     The primary objective of this study is to compare the efficacy of unilateral and bilateral     neuromodulation tests at 1 month.   "
131877|NCT01558843|"     This multicenter, observational, study will enroll severe neurologically injured patients     both prospectively and retrospectively. The aims are to identify the percent of neurocritical     care patients with sodium levels ≤ 135 mEq/L, describe treatment strategies employed,     determine the correlation of clinical factors (i.e. GCS, ICP) with serum sodium     concentrations in patients prior to sodium altering therapy, and evaluate outcomes through     evaluation of length of stay, discharge disposition, and modified Rankin score (mRS).   "
131878|NCT01558830|"     Ranolazine is an effective and remarkably safe agent for the treatment of patients with     chronic stable angina, but its inhibition of voltage gated potassium channels and     electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question     its safety when combined with antiarrhythmic drugs. The investigators have proposed a study     to determine the safety of ranolazine in patients with chronic stable angina who also take     amiodarone. And are conducting a prospective single-center randomized single-blinded placebo     controlled trial to run out of our large cardiology practice setting at Cardiovascular     Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular     arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia     episodes on serial holter monitor and other serially acquired recordings (such as     electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data)     over a three month trial period.   "
131879|NCT01558817|"     Outcomes after in-hospital cardiopulmonary resuscitation (CPR) are very poor, particularly in     patients with oxygen dependent chronic obstructive pulmonary disease (COPD) or metastatic     cancer. Recent work found that in-hospital CPR is being performed more often before death     with unchanging survival and that fewer CPR survivors are being discharged home, thus     suggesting that CPR is increasingly performed without benefit and that the burden of this     ineffective treatment is increasing. Unlike other medical procedures, CPR has become the     default provided to all patients even those with tremendously poor outcomes. It is time to     change the paradigm of CPR. Through comparing an innovative informed assent approach toward     in-hospital CPR (informing patients that their underlying chronic illness makes outcomes of     CPR so poor that CPR is not performed while allowing them to disagree) versus usual care in a     group of chronically ill patients with reduced life expectancy, the investigators aspire to     demonstrate that CPR delivery can be reduced. And in addition that DNR status increases,     while preserving patient quality of life and decreasing the burden of this ineffective     treatment to both patients and families. If effective, this informed assent intervention has     the potential to revolutionize how the investigators discuss CPR with the investigators     chronically ill patients.   "
131880|NCT01558804|"     The purpose of the research is to help understand why some children become carriers of strep     and whether children who are carriers need to be treated with antibiotics.   "
131881|NCT01558791|"     This research study is designed to learn about Veterans' understanding of mild TBI (traumatic     brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to one of the     study-related clinics for TBI screening will be invited to participate. An educational     handout on TBI will be given to half of the participants along with their TBI screening. The     other half of the participants will have the usual TBI screening without the educational     handout.      Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire.     The questionnaire will ask:        -  About the individual: such as gender and branch of service        -  About what happened during the TBI screening: such as whether the Veteran had a chance          to ask the provider any questions        -  About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are          long lasting      Veterans who receive the educational handout will be asked specific questions about the     handout and its information.   "
131882|NCT01558778|"     This pilot clinical trial studies mechanical stimulation in preventing bone density loss in     patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent, or     reverse bone loss, increase muscle and cardiac performance, and improve overall health   "
131883|NCT01558765|"     The aim of the study is to investigate the effect of an integrated rehabilitation programme,     consisting of physical exercise training and psycho-educational consultations, for patients     after heart valve surgery.      The hypothesis is that integrated rehabilitation can improve physical capacity measured by     V02 peak, self-rated mental health and life quality by validated questionnaires such as     SF-36, and other objective parameters such as cardiac-specific biomarkers and     echocardiographic measurements.   "
131884|NCT01558752|"     The main goal prospectively evaluate bone mineral density adjacent to the femoral component     and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem     compared to a modular titanium femoral stem (Tri-lock). The investigators expect the CORAIL     femoral stem group to show significantly less bone loss on the femoral side as compared to     the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD)     (g/cm2) from baseline (10-14 days post-op) to the one year post-operative interval, as     measured radiographically in zones 1 and 7.      Patients will be randomized to one of the two treatment groups prior to surgery. Each patient     will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits     following surgery.      Bilateral DEXA bone mineral density tests will be performed at 10-14 days following surgery     (baseline assessment) and at 6, 12, and 24 months post-operatively.      Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months     post-operatively after an overnight fast.      The Harris Hip Score will be completed at each post-operative visit except the immediate     (10-14 days), when risk of dislocation precludes a determination of range of motion. At the     3, 6, 12 and 24 month post-operative visits, the patient will complete the RAND-36 Item     Health Survey, WOMAC and UCLA activity scale.   "
131885|NCT01558739|"     The primary objective of this study is to evaluate the efficacy of INC424 in patients with     PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (> 50%     reduction in splenomegaly using palpitation at 48 weeks) and/or a subjective endpoint (>50%     reduction in total symptom score at 48 weeks).   "
131971|NCT01557829|"     This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into     two groups: one to receive a new ceramic implant and a control group with a more traditional     PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will     measure and compare pain and disability improvement with the two implanted devices over a     period of two years. The fusion status will also be judged with plane x-rays and one CT scan.   "
131886|NCT01558726|"     The purpose of this study is to evaluate the effectiveness of a Case Management (CM)     intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad)     by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days,     considering the following outcomes: treatment retention, abstinence and changes in severity     scores of the sixth version of Addiction Severity Index (ASI6) scale. The study hypothesis     are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month     follow-up compared with usual care (controls); 2)Individuals who received the intervention     with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6     will be significantly lower in cases than in controls, at the end of 3 months follow-up.   "
131887|NCT01558713|"     Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine     with addition of fentanyl for c-section either combined or not with administration of 10 ml     of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile,     haemodynamics and side effects were assessed.   "
131888|NCT01558700|"     This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after     treatment with either duloxetine or placebo is associated with changes in brain anatomy.   "
131889|NCT01558687|"     The main purpose of this clinical trial is to find out if cilengitide has an effect on brain     tumor cells but also particularly on the blood vessels supplying the tumor with nutrient and     oxygen in patients newly diagnosed with non-resectable (inoperable) glioblastoma.      In addition, this clinical trial will investigate if the addition of cilengitide in     combination with standard treatment prolongs life in patients with non-resectable     glioblastoma. Similarly, the duration of response of the cancer to this treatment and the     side effects of the therapy will be analyzed. Furthermore, additional data on how the body     deals with this substance will be collected (this is called pharmacokinetics or     pharmacokinetic (PK) analysis). In this clinical trial the investigators would also like to     learn more about the disease and the response to the experimental medication by measuring     certain markers.      This imaging trial will investigate the biological effects of cilengitide monotherapy on the     tumor microvascular function and tumor viability in a homogenous non-pretreated subject     population with newly diagnosed Gliobastoma (GBM). The purpose of this clinical trial is to     study the effect that cilengitide may have on certain markers of cancer in your tumor and/or     blood and to learn if there are any disease-related markers that could help in predicting how     subjects respond to the administration of cilengitide.      The investigators anticipate that approximately 30 subjects will participate in this clinical     trial. The clinical trial will be conducted in approximately 4 medical centers in the     following countries: Germany, Poland, and Switzerland. The investigators anticipate the     clinical trial will last until the end of 2013. Your participation in the trial may last up     to 86 weeks.   "
131890|NCT01558674|"     Part I is a 3-period, active comparator-controlled, fixed sequence study to evaluate the     safety, tolerability, pharmacokinetics and pharmacodynamics of MK-7145 compared to furosemide     in participants with moderate-to-severe renal insufficiency (RI) without heart failure (HF).     Primary hypothesis for Part I is that at least one well-tolerated dose of MK-7145 will     produce a greater 24hr urinary excretion of sodium (UNa) on the 1st day of MK-7145 dosing     than 80 mg furosemide (on the 1st day of furosemide dosing) in participants with     moderate-to-severe RI. If MK-7145 is safe at natriuretic doses in RI in Part I of this study,     MK-7145 will be investigated in participants with heart failure (HF) and RI (Part II).      Part II is 4 period, fixed sequence, active comparator controlled (in Period 1), titration     (in Periods 2, 3 and 4) study to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of a titration regimen of MK-7145 compared to an optimized stable     maintenance regimen of furosemide or torsemide in participants with New York Heart     Association (NYHA) Class II and III heart failure and moderate or severe renal insufficiency.     The primary hypothesis for Part II is that at least one dose of MK-7145, titrated according     to a fixed dose titration regimen, will be associated with a reduction in N-terminal     pro-brain natriuretic peptide (NT-proBNP) compared to furosemide or torsemide (at 24 hours     post morning dose on the last dosing day of each period) in participants with NYHA class     II/III HF with moderate or severe RI.   "
131891|NCT01558661|"     The purpose of this study is to find out what effects, good and/or bad, a new treatment     called axitinib has on the patient and adenoid cystic carcinoma. This type of cancer study is     called a phase II study.      Axitinib is an oral medication that can interfere with cancer cell growth and reduce the     growth of blood vessels around tumors. This study will help find out if axitinib is a useful     drug for treating patients with adenoid cystic carcinomas. Axitinib is an experimental drug     that has not yet been approved by the Food and Drug Administration for use in adenoid cystic     carcinoma.   "
131892|NCT01558648|"     The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's     quality of life over time. The investigators hope this study will provide important     information that can be used to improve the quality of life of patients with esophageal     cancer. This study will also look at how standard tests and information collected from the     patients difficulty swallowing can predict the extent of their esophageal cancer before     surgery.   "
131893|NCT01558635|"     Studies have shown that taking drugs to stay out of AF has limited success. This research is     designed to study heart rhythm after surgical therapy, namely by measuring if there are     benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex     Surgical Ablation System. The system is approved and commercially available with CE mark. The     purpose of this study is to support evidence that the Cardioblate System is safe and     effective to treat AF.   "
131894|NCT01558622|"     The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol,     tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen     fundoplication.   "
131895|NCT01555697|"     Cognitive training is moderately effective at reducing symptoms and improving life function     in schizophrenia patients. The present application develops a strategy for increasing the     effectiveness of cognitive training through the use of pro-cognitive medications. Specific     biomarkers will be studied that identify patients most sensitive to these pro-cognitive     medications, to test the feasibility of using these biomarkers in a large clinical trial of     medication-enhanced cognitive training in schizophrenia.   "
131896|NCT01555684|"     Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that     often results in reduced muscle function which produces fatigue, weakness and a decline in     daily mobility. Although the underlying cause of the disease is unknown a possible     contributory mechanism is chronic cerebrospinal venous insufficiency (CCSVI). Post-mortem     studies and magnetic resonance venography have shown a strong relationship between the     cerebral venous system and MS cortical plaques. From this a role for CCSVI in MS has been     suggested: venous malformations that result in venous hypertension, pressure on the blood     brain barrier and subsequent inflammation due to leakage of haemosiderin into the parenchyma.     This provokes an immune response which results in neurodegeneration. A procedure known as     percutaneous venoplasty whereupon a balloon is inserted and inflated into the jugular vein     has been developed to improve this drainage of the CNS, reduce venous hypertension and     improve symptoms associated with MS. Although this procedure is widely practiced throughout     the world it has yet to be fully accepted as it needs to be supported by evidence based     clinical trials. As such NHS National Institute for Health and Clinical Excellence (NICE)     recently issued a consultation document to determine more about the procedure's clinical     safety and efficacy. A common concern raised is the ability to prevent any possible placebo     effect and like any other clinical trial should offer a sham procedure to a matched control     group. The difficulty with this option are the ethical issues associated with an invasive     sham treatment and also the practical issues of masking a potentially painful treatment such     as venoplasty. One option is to have blinded neurological assessment of patients who have     either been treated with venoplasty or had no active treatment. Another option is to use     dependent measures that are unaffected by motivational or psychological influences which     avoids any placebo effect issue. One such dependent measure is motor unit firing behaviour     whilst contracting at a submaximal target force. Typically clinicians have used this to     manage motor disorder patients but have used cumbersome invasive technology that can only     measure a few motor units with limited accuracy. However, De Luca et al recently developed a     high density surface electromyographic (HDsEMG) system that can measure 30-40 motor units     with 92-97% accuracy. From this it has been proposed as a highly effective tool for     evaluating efficacy of therapeutic interventions for upper motoneuron disorders such as MS.      Accordingly the investigators propose to use a repeated measures design on an experimental     (receiving venoplasty) and control (not receiving venoplasty) MS groups (6 patients in each     group) to determine the effect of the treatment on muscular function, mobility and fatigue.     This would be combined with independent blinded neurological assessment of the two groups of     patients.      This design enables us to achieve two aims:        1. Acute neuromuscular response to the treatment        2. Chronic response to the treatment (6 weeks) to determine the effect on muscular          function, mobility and fatigue.*      Methods        -  Four (first two to establish baseline variability of measures) repeat visits to the          laboratory at University of Stirling to establish neuromuscular measures:             1. HDsEMG pre and post tetanic induced fatigue             2. Muscle fibre conduction velocity as previously described (Hunter et al., 2011)             3. Ultrasound for CCSVI determination on visits 1 and 3             4. DEXA scans for alterations in body composition on visits 2 and 4        -  With the use of accelerometers monitor free living activity on days 0-7 and 9-42 (post          venoplasty).   "
131897|NCT01555671|"     Labor pain is universal and occurs acutely. This is the most painful experience in a woman's     life. Pain relief during labor is expected to have positive impact on the progress, outcome     and cost of labor. However, it is controversial whether labor analgesia shortens the length     of labor and influences progression to cesarean.Labor analgesia can be performed via spinal,     epidural or systemic routes (intravenous or intramuscular). Opioid agonists (meperidine,     fentanyl etc.) as well are the systemic agents frequently used for labor analgesia.Results of     the studies concerning effect of meperidine on the length of labor are controversial.      Many studies have expressed that meperidine has no effect or effect on the progress of     labor.This study aims to evaluate the effect of meperidine on the length of active phase of     labor in nulliparous or multiparous women, who will be randomized into case and control     groups.   "
131898|NCT01555658|"     Background:      Randomized trials show improved outcomes among acute coronary syndrome (ACS) patients treated     with Bivalirudin1. Optimal antithrombotic treatment in patients undergoing percutaneous     coronary intervention (PCI) is crucial to balance the risk of post-PCI bleeding versus     ischemic complications2. Bivalirudin, a direct thrombin inhibitor has been extensively     investigated as an intra-procedural antithrombotic therapy in patients with stable angina,     Non ST-segment elevation acute coronary syndrome (NSTE-ACS), and ST-segment elevation     myocardial infarction (STEMI). Bivalirudin, when used with or without glycoprotein IIb/IIIa     inhibitors (GPI) during PCI has been found to be superior to Unfractionated heparin (UFH)     with or without GPI in reducing 30-day bleeding complications without significant increase in     the rate of ischemic events3-5.      Moreover,after otherwise successful PCI,an increase in cardiac biomarkers has been shown to     occur in 5% to 30% of patients6. Recent studies have focused their attention onthe reduction     of infarct size and the incidence of periprocedural (type IVa) myocardial infarction     (PMI)after elective PCI7-8. Therefore, we will perform a single-center, prospective and     randomized study to assess if Bivalirudin versus UFHis effective in preventing elevation of     biomarkers of MI after coronary stent implantation in patients already treated with aspirin     and clopidogrel,with anatomically complex lesion.      Objective:      to assess the safety and efficacy of routine usage of the Bivalirudin vs UFH in patients with     coronary artery disease (CAD), after stent implantation in coronary long lesions, to avoid     periprocedural myocardial necrosis.      Setting:      Single-center, spontaneous, prospective, randomized 1:1 study of Bivalirudin infusion vs UFH     in the setting of CAD, after PCI with stenting incoronary long lesions.      Comparison: Bivalirudin vs UFH, in preventing elevation of biomarkers of MI after coronary     stent implantation in patients already treated with aspirin and clopidogrel, with     anatomically complex lesion.      Population:Patients with diffuse CAD undergoing percutaneous treatment on a native coronary     vessel with planned implantation stents in overlapping with a total stent length >33 mm for     long coronary lesions in vessels with a reference vessel diameter 2.25-4.0 mm.      Assessment Following the procedure, blood samples for CK, CK-MB and Troponin will be     collected at 6,12 and 24 h post PCI. CK-MB values will be considered abnormal if they will     elevate above the upper limit of normal (ULN). This is set at 6 mg/L by our local laboratory.     If the first blood sample showed a CK-MB level ≥18 mg/L (≥3 times upper normal limit), a     second blood sample would be drawn every 8 h later until a downward trend will be observed.     For patients with two or more blood samples drawn, the peak CK-MB level will be used for     analysis.      End-points:      The primary end-point of this study will be the incidence of periprocedural myonecrosis that     was defined as a peak post-procedural CK-MB elevation > 1 time the upper limit of normal     (ULN) alone or associated with chest pain or ST-segment or T-wave abnormalities, in patients     undergoing non-urgent PCI.      Secondary end-points will be the rate of MACCE (major adverse cerebro-cardiovascular events,     ie the composite of death, myocardial infarction [defined according to the Academic Research     Consortium statement], target vessel revascularization or stroke), the rate of major     bleedings (Bleeding Academic Consortium [BARC] 3-5), minor bleedings (BARC 2), and the rate     of NACE (net adverse clinical events, ie the composite of MACCE and major bleedings) at 30     days, 6 and 12 month follow-up. Adverse events will be determined by telephone interview     and/or medical record review. Clinical follow-up: telephone-based interviews and office-based     direct visits will be performed at 1, 6 and 12 months, respectively, for end-point     adjudication.      Sample size and statistical analysis: Given an expected rate of abnormal post-procedural peak     CK-MB > 1 x ULM of 48% (based on results of the INSTANT trial) for the control group and 29%     for the experimental group (thus a 40% relative risk reduction), aiming for a 0.05 alpha and     0.80 power, a total of 204 patients will need to be enrolled (102 patients per group).   "
131899|NCT01555645|"     The purpose of this study within Caring sciences is to identify women with breast cancer who     have stress symptoms and to offer these women appropriate care to reduce stress and increase     well-being. This will be achieved by        1. Studying the prevalence of stress related symptoms in female patients with breast cancer        2. Testing the use of two short screening instruments to identify women at risk for          developing long-standing stress symptoms        3. Studying the level and intensity of stress management interventions required to achieve          increased well-being, using a stepped-care approach.        4. Studying the effects of interventions based on cognitive behavior therapy, delivered          individually or in a group format.      The hypothesis is that half of the individuals assigned to a low intensity intervention will     be significantly improved after treatment. For individuals who continue to have symptoms     after low intensity treatment it is hypothesized that continued treatment in a group setting     with high intensity interventions will be more cost-effective. In addition the assumption is     that reduction of stress symptoms in women with breast cancer will lead to a reduction in     socio-economic costs.   "
131900|NCT01555632|"     This randomized pilot clinical trial studies atorvastatin calcium in preventing metabolic     syndrome in patients with prostate cancer receiving long-term androgen-deprivation therapy.     Atorvastatin calcium may help prevent or reduce metabolic syndrome caused by long-term     androgen-deprivation therapy   "
131901|NCT01555619|"     The purpose of this post approval study is to evaluate the acute and chronic performance of a     Quadripolar CRT-D device system in a patient population indicated for cardiac     resynchronization therapy.   "
131902|NCT01555606|"     The purpose of the study is to develop a database containing patient-reported information     that may be used to understand and to increase awareness of the impact that     moderate-to-severe plaque psoriasis can have on both daily life and life in general from a     patient's perspective. The database will include self-reported patient narratives on the     topic of the experience of having moderate-to-severe plaque psoriasis and will include     information on treatments received, as well as de-identified clinical photographs taken over     the course of the disease.   "
131903|NCT01555593|"     -  Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is caused by          inflammation of peripheral airways walls.        -  Neutrophils and other inflammatory mediators Interleukin-6 (IL6), Interleukin-8 (IL8),          Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor          alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric Oxyde (NO)          are implicated in the inflammation.        -  Exhaled NO concentration is usually used to monitor bronchial inflammation        -  The relationship between decubitus and small airways behaviour is not well understood.        -  Our hypothesis is that cyclic opening and closure of peripheral airways during decubitus          can provoke an inflammatory response which can be monitored by exhaled NO.        -  Data about these physiopathological aspects is missing in literature.   "
131904|NCT01555580|"     The purpose of this study is to determine whether the drug Leukine (GM-CFS) is safe and     tolerated by patients with autoimmune myasthenia gravis (MG).   "
131905|NCT01555567|"     Quadriceps muscle weakness is a common consequence of ACL injury. This muscle weakness is     considered to result from neural inhibition preventing full muscle contraction and is     referred to as arthrogenic muscle inhibition (AMI). AMI hinders rehabilitation by preventing     gains in strength, increasing the risk of re-injury, and potentially placing patients at risk     for chronic degenerative joint conditions. Quadriceps weakness that occurs following ACL     injury is also thought to be caused by muscle atrophy which is thought to manifest due to     alterations in muscle architecture, selective fiber atrophy or even neural deficits such as     AMI. Importantly, interventions that are designed to counter this muscle weakness are     required in order to promote long-term knee joint health. Hence, the purpose of the current     study is to determine the efficacy of interventions that target quadriceps weakness to     improve quadriceps muscle function and biomechanics in patients prior to and following ACL     reconstruction. Specifically, the efficacy of neuromuscular electrical stimulation aimed at     improving quadriceps neural activity and eccentric exercise intended to minimize quadriceps     muscle atrophy will be investigated. The investigators expect that patients who receive the     electrical stimulation therapy will demonstrate improvements in quadriceps strength and     activation. Furthermore, it is expected that patients who receive both the electrical     stimulation and eccentric intervention will demonstrate markedly greater gains in quadriceps     strength and activation than patients who receive only the electrical stimulation therapy or     standard of care post-surgery. The investigators also hypothesize that the patients who     receive the electrical stimulation therapy and/or eccentrics will display knee motion similar     to uninjured control subjects.   "
131928|NCT01558388|"     Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of     Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic     bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased     risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial     vaginosis has been reported in 10-70% of cases. This study aims to verify if administration     of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of     bacterial vaginosis during pregnancy.   "
132280|NCT01553539|"     This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line     therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be     removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking     blood flow to the tumor.      Funding Source - FDA Office of Orphan Drug Products (OOPD)   "
131906|NCT01555554|"     Understanding what treatments may facilitate perioperative care of Veterans with     posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.      Patients with PTSD are characterized by elevated central nervous system catecholamine     concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At     present, there are no data on the effects of perioperative beta blocker therapy in patients     with PTSD, despite the rising significance of PTSD in Veteran populations.      This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled     for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either     a 14-day course of propranolol or placebo. This study will then follow these Veterans for a     one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.      The investigators hypothesize that patients with PTSD randomized to the propranolol group     will demonstrate a reduced incidence of perioperative and postoperative morbidity and     mortality.   "
131907|NCT01555541|"     The goal of this clinical trial is to show that incorporating ofatumumab instead of rituximab     in combination with etoposide and cytarabine (OVA) is successful in collecting autologous     stem cells for use in an autologous stem cell transplantation (autoSCT) and to examine its     effectiveness in eliminating residual diffuse large B-Cell Lymphoma (DLBCL) in patients.   "
131908|NCT01555528|"     This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
131909|NCT01555515|"     In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will     get it by a small implant of skin using their own skin, the implant will be treated in the     laboratory and programmed to secrete Epo. The implant secretes the patients own epo     minimizing the need for injections for a period of up to 6 months.   "
131910|NCT01555502|"     To test the effect of post operative complications on the health related quality of life     (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer     (NSCLC).      The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery)     using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at     regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be     assessed using the same questionnaires to determine the difference between patients with     low/no post operative complications to those with high grade post-operative complications.      Post operative complications will be assess while the patients in the hospital on a daily     basis using the Clavien classification system for surgical complications.   "
131911|NCT01555489|"     The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA)     plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic     cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic     acid is safe when given with the chemotherapy. This Phase II trial is an initial test of     efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard     chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic     cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line     treatment. The phase I data suggests that ascorbic acid when given in combination with     gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to     better evaluate the response and confirm initial safety data   "
131912|NCT01558596|"     The investigators have previously shown that elective vascular surgery is a high-risk     operation with an anticipated risk of either death or heart attack of 15%. This study is     testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior     to the operation is safe, feasible and reduces the incidence of an adverse, perioperative     cardiac complication.   "
131913|NCT01558583|"     Participants will be recruited from the United States and Australia to take an online survey     about colon cancer screening or prostate cancer screening. Individuals selected for both the     prostate cancer survey and the colon cancer study will be randomized to take one of three     survey types - balance sheet, rating and ranking or conjoint analysis. These surveys will     help participants clarify their values and opinions about screening options for colon cancer     or prostate cancer. Participants' responses to the online survey are measured at one point in     time - the time at which the participant takes the survey.   "
131914|NCT01558570|"     The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia.     This one time visit will collect zonulin levels, antibodies to gliadin (tissue     transglutaminase and antigliadin antibodies) and other information that may relate to     increased intracellular tight junction permeability as it related to the immune and stress     system and the immune association with kynurenic acid pathway 50. Data will be collected for     use in future grant applications and published reports.   "
131915|NCT01558557|"     Background: Celiac disease is an immune-mediated reaction to gluten, presenting with     diarrhea, weight loss, abdominal complaints and a range of less common associated neurologic     and psychiatric symptoms. Evidence of a link between schizophrenia and celiac disease dates     back to 1961. Recent evidence shows that 5.5% (age adjusted) of persons with schizophrenia     participating in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)     study had a level of antibodies to tTG that is consistent with a diagnosis of celiac disease     (compared to 1.1% of the comparison sample). An unexpected finding was that 23.4% (age     adjusted) of the CATIE sample had antibodies to gliadin (compared to 2.9% of the comparison     sample). It is hypothesized that a gluten free diet in people with schizophrenia who have     Celiac disease or gluten sensitivity will have improvement in symptoms and quality of life.      Objectives: The aim of this proposed pilot study is to establish the feasibility of a     initiating and maintaining a Gluten-free diet in these two groups. For this study The     investigators will identify 8 individuals who have positive assays to tTG antibodies and     confirmed celiac disease (N=4), or positive assays for anti-gliadin antibodies (N=4). The     investigators plan to consent at least 2 subjects from each group and ask them to participate     in a two-week open label treatment of a gluten free diet. The groups are;        1. Celiac disease (positive tTG antibody); and        2. Positive assay on Antigliadin antibodies   "
131916|NCT01558544|"     The study hopes to contribute to the development of technologies of ovarian tissue     freezing-thawing and in vitro maturation of immature eggs such that a person at risk for     premature ovarian failure might be able to conceive a genetically related child.   "
131918|NCT01558518|"     Transthoracic echocardiography (TTE) represents an established and fundamental tool for the     evaluation of patients with known or suspected cardiovascular disease. Recently,     manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a     physician's lab coat. Studies assessing these handheld devices have several limitations.     While they have generally evaluated the handheld devices favorably, previous studies has not     consistently studied handheld devices under the best possible clinical conditions and have     not necessarily highlighted the devices' limitations.      In this proposal, we seek to analyze the applicability of handheld echocardiograms to     standard clinical practice. The investigators plan to use trained sonographers to perform     handheld examinations on patients referred for TTE without established cardiovascular     disease. The handheld images will be interpreted by experienced, consultant-level     echocardiographers. The investigators then plan to compare findings from the handheld     echocardiogram to the patient's standard clinical TTE.   "
131919|NCT01558505|"     Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral     intervention (PTA). The aim of the study is to investigate in a randomized fashion the     efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia,     Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in     diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK)     vessels.   "
131920|NCT01558492|"     The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel     and correlate response to study treatment with biologic parameters (i.e. lab studies of     blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into     the underlying biology of prostate tumor progression and perhaps predict which patients may     benefit from this chemotherapy regimen.   "
131921|NCT01558479|"     The Parkinson's Genetic Research Study (PaGeR), headed by Dr. Cyrus Zabetian, is searching     for genes that increase the risk of developing Parkinson's disease (PD) and related     disorders. The study is a joint effort by neurologists and researchers across the United     States and is sponsored by the National Institutes of Health. The coordinating center for     PaGeR is located at the University of Washington and the VA Puget Sound Health Care System in     Seattle.   "
131922|NCT01558466|"     This study hopes to evaluate the effectiveness of early combined use of Sildenafil and nitric     oxide (iNO) in newborns with Persistent pulmonary hypertension (PPHN) and or hypoxemic     respiratory failure and assess whether this would improve oxygenation, improve time on     mechanical ventilation for these babies and also prevent rebound hypoxic episodes.   "
131923|NCT01558453|"     The purpose of this study is to determine the pediatric neoplastic response to chemotherapy     proposed and evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1     expression analysis.   "
131924|NCT01558440|"     Hypothesis:      During rehabilitation phase of management of severe acute malnourished Bangladeshi infants     less than 6 months old, rates of weight gain will be significantly more in children fed F-100     and diluted F-100 compared to those fed infant formula.      Brief summary:      Until recently, severe malnutrition has been relatively rare in infants younger than 6     months, but with urbanization and the HIV/AIDS pandemic it is feared that the incidence of     severe malnutrition among young infants will rise. The question of how best to feed infants     aged <6 months has thus come to the forefront. Given the lack of published evidence regarding     the most advantageous formulations for feeding severely malnourished infants aged <6 months,     there is a need for observational studies and comparative randomized trials of alternative     formulations to guide decisions about optimum dietary management in this age group. This area     has been aptly considered a research priority during the consultation meeting of experts from     all over the world convened by the World Health Organization on management of severe     malnutrition in September 2004.      In the WHO case-management guidelines for severe malnutrition, there is no separate provision     for young infants (infants less than 6 months old). The guidelines suggest the use of a     low-solute formula (F-75) and continued breastfeeding in the initial stabilisation phase. In     the rehabilitation phase, the guidelines advise F-100 with an energy density of 100kcal/100ml     to promote catch-up growth. There is a concern that the renal solute load from using F-100 is     too high for young infants, and some groups have started using diluted F-100 with an energy     density of 75 kcal/100 ml.      Another related issue is the contribution of breastfeeding in dietary intakes during     rehabilitation. In severely malnourished infants, breast milk intakes are likely to be low     initially when appetite is poor, but may be substantial as the infant recovers. Uncertainty     about breast milk intakes has led to conflicting opinions and advice, weaning from the breast     as it is not providing sufficient energy (1).      The aim of this study, to be conducted in a carefully supervised Nutrition Rehabilitation     Unit (NRU), will compare three recovery diets (Infant formula, F-100 and diluted F-100) in     order to provide the evidence-base to determine if a change or add-on in terms of diet in the     WHO guidelines is needed. It will also measure the potential renal solute load (mosmol/l),     serum electrolytes and plasma osmolality of the same children. Body composition of the     infants will also be measured using stable isotope dilution technique before and after the     intervention diet is provided.   "
131925|NCT01558427|"     Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are     conventionally treated with androgen deprivation therapy. However, in patients with limited     metastatic load, the time to progression might be. Subsequently, active surveillance of these     patients until progression might defer the start of androgen deprivation therapy (ADT) for     several months to years. As an alternative, salvage treatment of the limited number of     metastases with either surgery or radiotherapy might postpone the start of ADT even longer.     The current trial hypothesizes that ADT might be deferred longer following salvage treatment     as compared to active surveillance.   "
131926|NCT01558414|"     Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study     will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a     transumbilical single site incision will be performed with two different manners: single-port     device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory     trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the     control one, a conventional laparoscopic approach.      The trial is designed as a pilot study to assess, as main objective, if these two endoscopic     approaches have the same security and effectiveness in cholecystectomy.      Hypothesis:      Transumbilical approaches with single port and single incision with the flexible endoscope     have the same efficacy and safety performing the endoscopic cholecystectomy.      Objectives:      Main objective:      Assess whether both approaches are equally safe in its application to endoscopic     cholecystectomy.      Secondary objectives:      Investigate the differences in the rate of conversion to open surgery between different     surgical approaches.      Investigate the differences in the rate of wound infection between the different surgical     approaches.      Investigate the differences in the rate of postoperative incisional hernias between different     surgical approaches.      Investigate whether there are differences in the rate of overall complications, all-cause     mortality and the cost between different surgical approaches.   "
131927|NCT01558401|"     The purpose of this study was to identify the effects and the efficiency of an adapted     physical activity program as regards the physical condition of older Brazilian women.   "
131929|NCT01558375|"     Aim of this double-blind, randomized, controlled clinical trial is to compare the safety and     the efficacy of anakinra over placebo for the management of patients with hidradenitis     suppurativa (HS) of Hurley II and Hurley III disease stage. Patients will be evaluated on     subsequent follow-up visits. Two scores will be applied: disease activity as assessed in the     protocol by the investigator; and Sartorius score. Primary efficacy endpoint will be the     comparisons of visual analogue scores, of disease activity, of Sartorius score and of     dermatology life quality index between the two groups of treatment over follow-up.   "
131930|NCT01558362|"     The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient     management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian     Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute.     Initial testing results in rats and pigs suggest that in addition to being a     cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for     measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability,     biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization     of I123-CMICE-013in healthy adult volunteers.   "
131931|NCT01558349|"     The main objective of this study is to compare results for the detection of circulating     melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques     between a group of patients with metastatic melanoma and a group of hospitalized control     patients.   "
131932|NCT01558336|"     The purpose of this study is to evaluate the impact of praziquantel for the treatment of     Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.   "
131933|NCT01558323|"     This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of     renal impairment to healthy subjects   "
131934|NCT01558310|"     This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous     injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose     of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of     scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp     specific physician assessments. The study will include approximately 30 subjects.   "
131935|NCT01558297|"     This study will test the effectiveness of two distinct treatments for weight loss:        1. Motivational Interviewing        2. Nutritional Counseling. These treatments will be compared to Treatment as Usual.          Participants will be recruited through local primary care offices.   "
131936|NCT01558284|"     Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS,     20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and     5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.   "
131937|NCT01558271|"     The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in     participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.   "
131938|NCT01558258|"     Younger women with breast cancer experience substantially greater distress and depressive     symptoms than older women. These symptoms can hamper recovery and healthy behaviors that can     reduce the risk of recurrence and/or other chronic diseases. The primary objective of this     study is to evaluate the feasibility and preliminary efficacy of a mindfulness     meditation-based intervention for this at-risk group of women. The investigators hypothesize     that a structured program of mindfulness meditation will lead to significant improvements in     psychological well-being (i.e., depression, stress), with corresponding improvements in     health behaviors and biomarkers of cancer risk, in women diagnosed with breast cancer, prior     to age 50. The investigators will also examine mechanisms for intervention effects, including     increased mindfulness and ability to relax.   "
131939|NCT01558245|"     The study aims to determine whether tissue kallikrein (TK) is efficacy for preventing the     long-term in-stent restenosis (ISR) after stenting of symptomatic atherosclerotic stenosis of     the middle cerebral artery (MCA) M1 segment   "
131940|NCT01558232|"     The objective of this clinical study is to examine acute changes in stability, force     allocation, work, and mobility from using a wearable, portable, battery-operated robotic     orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity     physical therapy.   "
131941|NCT01558219|"     This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of     metastatic castration resistant prostate cancer (mCRPC) patients previously treated with     docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include     time to treatment failure, response rate, overall survival and quality of life.   "
131942|NCT01558206|"     In this study the investigators compare the diagnostic validity of Bedside Ultrasonography of     chest and Pulmonary artery CT Angiography in the patients who came to Emergency Department of     Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory symptoms and     signs in favor of Pulmonary Thromboemboli (PTE).   "
131943|NCT01558193|"     There is a series of well designed studies that have reported, in those with a history of     anti-social behavior, that supplementation with vitamins / minerals, omega-3 fatty acids (n-3     FA), or both, reduces the incidence of aggressive behavior. Although there is evidence that     all these nutrients have a role, to date the relative contribution of fatty acids and     vitamins / minerals has not been considered: for example the possibility of a synergistic     interaction has not yet been examined. In addition the topic has to date been studied under     real-life condition, such as a prison, making the topic difficult to study. The major aim of     the present study was to develop a paradigm that would allow the study of the topic in a     sample from the general population without a history of anti-social behavior. Subjects     received either a vitamin/mineral supplement, a fatty acid supplement, both or neither for     three months, Measures of impulsivity and aggression were assessed before and after     supplementation. Although in the past measures of actual behaviour have proved to be     sensitive to supplementation, questionnaire measures have not. The second major objective was     therefore to consider whether such phenomena can be studied in a sample without a history of     anti-social behavior, using standardized, sensitive laboratory based measures and to compare     these with questionnaire measures.      POLYMORPHISMS AND THE RESPONSE TO MICRO-NUTRIENT SUPPLLMENTATION The data set were     subsequently used to test an a priori hypothesis not related to the initial hypothesis. A     meta-analysis found a consistent pattern that micro-nutrient supplementation improved mood     (Long SJ, Benton D. Effects of vitamin and mineral supplementation on stress, mild     psychiatric symptoms, and mood in nonclinical samples: a meta-analysis. Psychosom Med 2013;     75: 144-153). To produce evidence of possible mechanisms the extent was determined, to which     the impact of micro-nutrient supplementation was influenced by a range of polymorphisms     associated with neurotransmitter systems known to modulate mood.      The primary outcome measure was the General Health Questionnaire, a 30-item self-report     questionnaire that was developed to detect, in a community sample, those who would benefit     from seeing a psychiatrist.      Given the literature that relates polymorphisms to mood disorders, and the known pharmacology     of anti-depressant drugs, a range of polymorphisms were chosen associated with serotonin and     catecholamines.      Dopamine The SNPs associated with the metabolism and functioning of dopamine were: Dopamine     beta hydroxylase (DBH, rs16111115); Dopamine transporter (DAT1, rs2550946);     Catechol-O-methyltransferase (COMT, rs4680, rs6269). Dopamine receptor D1 (DRD1, rs4532);     Dopamine receptor D2 (DRD2, rs1079598, rs1800497); Dopamine receptor D3 (DRD3, rs6280);     Dopamine receptor D4 (DRD4, rs1800955).      Serotonin Ten SNPs associated with different aspects of serotonin metabolism were also     considered. Rs1843809 is a SNP of the TPH2 gene that encodes Tryptophan hydroxylase.     Rs1050565 is a SNP in the BLMH gene that influences the activity of 5HTT (SLC6A4), the     serotonin transporter. SNPs associated with various serotonin receptors were also examined:     genetic variations of the HTR1A gene (5-HT1A receptor, rs6295); HTR1B gene (5-HT1B receptor,     rs6296); HTR2A gene (5-HT2A receptor, rs6311); HTR2B gene (5-HT2B receptor, rs1549339); HTR2C     gene (5-hydroxytryptamine receptor 2C, rs518147); HTR3A gene (5-hydroxytryptamine receptor     3A, rs1150226); HTR3B (5-HT3B receptor, rs1672717); HTR4 gene (5-HT4 receptor, rs2278392).      Adrenergic mechanisms Finally six SNPs associated with adrenergic receptors were considered:     ADRA2A (adrenoceptor alpha 2A, rs553668); ADRB1 (adrenoceptor alpha B1, rs1801253); ADRB2     (adrenoceptor alpha B2, rs1042713; ADRB3 (adrenoceptor alpha B3, rs4994); SLC6AC     (noradrenaline transporter, rs5569 and rs2242447).      Analysis The data will be analyzed using analysis of variance with a change in GHQ from     before to after supplementation as the dependent variable: Micronutrient/placebo X     Polymorphism.   "
131944|NCT01558180|"     The investigators will conduct a randomized controlled trial comparing a telephone based     intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series     of phone calls to assist caregivers in learning and modifying behavioral strategies that may     help young children with autism to sleep better. Objective (activity monitors) and subjective     (rating scales) data will be collected by an independent research assistant at the end of the     project. The investigators hypothesize that TCM improves sleep duration and decreases sleep     problems relative to a usual care control condition (UC).   "
131945|NCT01558167|"     This is a prospective, multicenter, open label, non-randomized, phase I/II-study to define     safety and efficacy of BRL combination in relapsed/refractory patients and to recommend a     safe and efficacious dose for future phase II/III study.      Hypothesis: The simultaneous administration of BRL in relapsed CLL is feasible, safe and     efficient.   "
131946|NCT01558154|"     Comparison of different assessment methods to evaluate the treatment efficacy of Chinese     medicine on minor and mild depression.   "
131970|NCT01557842|"     The purpose of this study is to determine if early ablation (i.e., ablation of ventricular     tachycardia in patients with infrequent VT episodes) is more effective than medical therapy     alone for the treatment of ischemic ventricular tachycardia in patients with Implantable     Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia     despite drug therapy.   "
131947|NCT01558141|"     Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy,     which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm     insemination, embryo culture and embryo transfer.      The oocytes are removed during surgery by aspirating the follicles using a single lumen     needle with an ultrasound to guide the procedure. There is some data that flushing the     follicles with embryo culture media before aspiration using a double lumen needle increases     the number of oocytes retrieved, particularly among poor responding patients for whom each     additional oocyte recovered may substantially alter the outcome of that IVF cycle.      The objective of the research is to evaluate the effect of follicular flushing in poor     responders on IVF cycle outcomes.   "
131948|NCT01558128|"     To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop     postoperative atrial fibrillation   "
131949|NCT01558115|"     Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone     (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen     most often in postmenopausal women. Many patients with PHPT have low bone mineral density     (BMD) when bone mass is measured by dual energy x-ray absorptiometry (DXA), primarily at the     forearm. There is currently no effective medical therapy which increases bone density at the     forearm in patients with PHPT.      PTH both builds and breaks down bone, and the pathways by which PTH mediates these actions     are beginning to be identified. Prior research suggests that RANKL, a molecule important in     bone metabolism, responds to PTH, and that if the RANKL is inactivated, PTH is shifted     towards building bone. The investigators will study the effect of Denosumab, a therapeutic     agent that binds to and inactivates RANKL, in 28 postmenopausal women with PHPT. Our     hypothesis is that Denosumab will increase bone mineral density in primary     hyperparathyroidism.      The study will last two years, and subjects will be randomly assigned to receive either     placebo or Denosumab for the first year of the study. In the second year, all subjects will     receive Denosumab. Denosumab (60 mg) or placebo will be given every 6 months by an injection     just under the skin. Study procedures performed will include bone mineral density tests by     DXA, high-resolution peripheral quantitative computed tomography (HR-pQCT) scans, and     assessments of biochemical markers of calcium metabolism and bone turnover using both blood     and urine samples of subjects with PHPT.   "
131950|NCT01558102|"     The primary objective of this retrospective study is to determine the incidence of important     safety outcomes in patients who have undergone Pipeline Embolization Device placement for     intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed     to observe and capture information from numerous hospitals.      Data collection will be initiated starting March 2012 and continue until approximately April     2017.   "
131951|NCT01558089|"     This open-label, prospective, observational study will evaluate the clinical response to     etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis,     as prescribed by the rheumatologist in a normal clinical setting in Greece   "
131952|NCT01558076|"     The purpose of this study is to use comprehensive exercise testing to examine longitudinal     changes in exercise capacity over a 2 year period in children and young adults with sickle     cell anemia.   "
131953|NCT01558063|"     Depressed patients will be offered experimental treatment with a new, potentially fast-acting     antidepressant called ketamine while being scanned by magnetic resonance imaging (MRI) to     measure the chemical effect of the drug. Ketamine will be given in a dose of 0.0 (placebo),     0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg. If a patient does not respond to ketamine after the first     infusion, it may be because s/he received ketamine placebo or the dose of ketamine was too     low. In that case, an optional second scan and infusion of active ketamine (0.5 mg/kg) will     be offered. This second scan will occur no later than weeks after the first scan/infusion (as     scheduling permits). There is no guarantee that the patient will respond to the second     ketamine infusion. Patients enrolled in the study are eligible for up to 6 months treatment     with their study psychiatrist after the ketamine infusion(s).      Healthy Volunteers: Healthy controls will receive an infusion of ketamine at a single dose     (0.5 mg/kg). Volunteers will only receive one MRI scan and infusion.   "
131954|NCT01558050|"     In this study the investigators investigate the effect of a red rice product on plasma lipids     in a sample of physicians and/or their family members.      After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to     receive a commercially available red rice product or placebo. After a period of 8 weeks,     lipid levels are measured again.   "
131955|NCT01558037|"     Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having     evidence of having the infection at sometime in their life. Patients who have undergone     transplantation are at risk at developing CMV, especially those patients who do not have     antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies     to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware they     have the infection without tests to detect the virus. CMV can less commonly cause serious     infections that affect many parts of the body including the intestines, liver, or lungs. In     rare cases CMV infection in transplant patients can cause death.      All patients who receive a transplant are monitored for CMV infection. The purpose of this     study is to determine if there is a way the investigators can determine in advance which     patients are at greatest risk of CMV infection. Specifically, this study will analyze the     immune system of transplant patients to determine if there are specific elements of the     immune system that 1) helps protect the body against CMV infection, and 2) helps the body     combat CMV once it is infected. Identifying these specific elements of the immune system     could improve the physician's ability to monitor the SOT patients for CMV infection, and to     help treat CMV in those patients that become infected.   "
131956|NCT01558024|"     The main objective of this study is to obtain data to determine, in each individual with and     without wearing compression stockings of different strengths and during different postures,     the relationship between interface pressure and the area and circumference of the great     saphenous vein and posterior tibial veins in the calf and ankle.   "
131957|NCT01558011|"     This is an open-label, non-comparative phase II study of sequential capecitabine plus     oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric     adenocarcinoma.   "
132281|NCT01553526|"     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring     coronary revascularization with Drug Eluting Stents (DES).   "
131958|NCT01557998|"     Interventions for injecting drug users (IDUs) in sub-Saharan African have been almost     entirely absent, despite the fact that in countries like Kenya they contribute a growing     proportion of incident HIV infections. This study will leverage a historic decision in Kenya     to launch needle exchange program (NSP) and related services for this most-at-risk population     (MARP). The investigators will use this NSP/MARP platform to seek out IDUs, deliver rapid HIV     testing, point of care CD4 count and link to ART using peer case managers, and evaluate     community viral load impact using a stepped wedge cluster-randomized design. Lessons learned     will have important applicability throughout sub-Saharan African.   "
131959|NCT01557985|"     This study is being done to try to learn more about how a child's body breaks down     bupivacaine, a local anesthetic medication that is being used for pain control. This study     will provide information about how much medication gets into the bloodstream and how long it     remains in the blood. Newborns and young infants often process drugs in their body in a     different way than older children. This study will help the investigators determine how     bupivacaine is broken down in the body of infants.   "
131960|NCT01557972|"     Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at     home (HBP) in the morning offer stronger predictive power for micro- and macrovascular     complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure     measurements (CBP) (Kamoi K et al, 2002-2003). Further, a prospective, longitudinal study for     6 years in patients with type 2 diabetes also demonstrated that control of wakening-up HBP     provides the stronger predictive power for the outcomes than that of CBP did (Kamoi et al,     2010).      However, it is not clear to show which of BP measurement provides the stronger predictive     power for outcomes by comparing cumulative events over a longer time than 6 years. Therefore,     the investigators examined which of HBP or CBP provides the stronger predictive power for     outcomes in addition of renal anemia reported previously over 10 years in the patients with     type 2 diabetes.   "
131961|NCT01557959|"     This phase II trial is studying how well docetaxel given together with cisplatin and     pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB     or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim,     may increase the number of immune cells found in bone marrow or peripheral blood and may help     the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride     may kill more tumor cells   "
131962|NCT01557946|"     Primarily, this study seeks to evaluate whether citalopram treatment is associated with an     increase in the Glutamine (Gln)/Glutamate (Glu) ratio in the anterior cingulate cortex (ACC)     from baseline to day 3 of treatment. Additionally, this study would like to examine whether     citalopram treatment is associated with an increase in the Gln/Glu ratio in the ACC from     baseline to day 7 of treatment.   "
131963|NCT01557933|"     The primary purpose of this study is to use magnetic resonance spectroscopy (MRS) to measure     the levels of several brain chemicals including, but not limited to, glutamate, glutamine,     and N-acetylaspartate, before and after treatment with ECT. In addition to MRS, the     investigators will use several other MRI techniques including structural MRI, resting state     functional MRI (fMRI), and diffusion tensor imaging (DTI) to measure how the structure and     function of the brain changes with ECT.      The investigators hypothesize that the Gln/Glu ratio is increased in the anterior cingulate     cortex (ACC), but not the parieto-occipital cortex (POC), following the first ECT treatment.   "
131964|NCT01557920|"     The investigators hypothesize that propofol, when compared to sevoflurane, causes the upper     airway to collapse more easily and causes less activity in the tongue muscle. Additionally,     the investigators hypothesize that, under increased carbon dioxide concentrations of the air     inhaled, the upper airway will be less likely to collapse under anesthesia and there will be     increased activity in the tongue muscle under both propofol and sevoflurane, when compared to     breathing normal concentrations of carbon dioxide, as in room air. Furthermore the     investigators hypothesize that anesthesia disrupt the breathing swallow coordination, an     effect additionally altered by increased carbon dioxide through increased respiratory drive.   "
131965|NCT01557907|"     The primary objective of this study is to investigate if intradermal (in the skin) basal and     bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately     control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period     of up to three days and if intradermal delivery of insulin has advantages over standard     subcutaneous (under the skin) delivery.   "
131966|NCT01557894|"     The main aim of this study is to investigate the effectiveness of an Internet-delivered     intervention for social phobia by comparing it to a waitlist control group. The second aim of     the study is to track the potential changes in participants' thinking patterns. Because this     is among the first guided Internet-delivered interventions conducted in Romania, the     treatment credibility will also be investigated. Finally, the predictive power of anxiety     sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.   "
131967|NCT01557881|"     This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging     (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as     PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to     treatment   "
131968|NCT01557868|"     The purpose of this study is to evaluate whether the investigators can develop a computer     algorithm to predict which individual patients will respond to injections of hyaluronic acid     (HA) products for knee osteoarthritis.   "
131969|NCT01557855|"     The objective of this study is to collect data on the commercial use of CORUS® (validated     quantitative in vitro diagnostic test) Coronary Artery Disease (CAD) blood test to evaluate     the clinical referral patterns of Primary Care Physicians after receipt of their patients'     CORUS Score, and to better understand patient management patterns for clinicians ordering the     test.   "
132334|NCT01552837|"     The aim of the study was to determine the pharmacological induced equivalents of neurogenesis     and synaptic sprouting in the hippocampus, localized volume changes, changes in water content     and neurochemical changes in the medial temporal regions.   "
131972|NCT01557816|"     This study aims to evaluate various methods of measuring pain relief in subjects who have     chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be     treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day     followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment,     subjects will have another week of wash-out followed by a second period of 1 week of the     alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory     drugs (NSAIDs) or other oral analgesics, or topical medications on their target knees during     the study. Acetaminophen will be allowed as a rescue medication.   "
131973|NCT01557803|"     The objective of this project is to determine clinical and biological predictors of Immune     Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are     started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of     this syndrome. The investigators will prospectively study HIV infected patients in Sub     Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its     different appearances. In these patients, the investigators will assess the value of clinical     features and plasma biomarkers to predict IRIS, and the investigators will obtain insight     into which inflammatory pathways become activated during IRIS. This project will provide     novel knowledge about this clinically highly relevant healthcare problem in a resource poor     setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little     research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will     be described. Promising putative plasma biomarkers will be validated for their use in daily     practice.   "
131974|NCT01557790|"     Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with     Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the     Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of     Defense. In the feasibility portion of the study patients will be evaluated to determine     acute toxicity. If the study is deemed feasible the principal investigator (PI) hopes that     proton RT will reduce the lethargy rate as compared to photon radiation therapy (RT).   "
131975|NCT01557777|"     Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).   "
131976|NCT01557764|"     This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together     with trastuzumab in treating patients with HER2-negative breast cancer that carries HER2 gene     mutations. Lapatinib may kill tumor cells by blocking some of the enzymes needed for cell     division and growth. Trastuzumab, a monoclonal antibody, may block the ability of tumor cells     to grow and spread. Giving lapatinib together with trastuzumab may provide a more effective     treatment for patients with this type of cancer.   "
131977|NCT01557751|"     In preparation for future large-scale genome wide association studies, reliable methods must     be developed for measuring perceived pain and for estimating the effects of potentially     confounding factors such as appropriate covariates. The major objectives of our pilot     investigation are to develop optimal methods to characterize the primary endpoint of the     study—knee pain, and to gather preliminary data on genetic markers in the human genome that     are associated with a certain pain phenotype. The specific issues for this study will be to     carry out a preliminary gene association analysis of acute perioperative pain in individuals     undergoing total knee replacement and to define a pain phenotype that is composed of     multidimensional domains such as opioid consumption, inflammatory markers, anxiety level,     degree of catastrophizing, etc. This pain phenotype has to be sensitive enough to pick up     changes in pain experience that can be attributed to single nucleotide polymorphisms.   "
131978|NCT01557738|"     It has well known that diets rich in fruits, vegetables and cocoa products are associated     with positive health benefits and these positive effects have been shown to be due to     compounds they contain called flavanols. Flavanols have been shown to exert their positive     effects by indirectly increasing nitric oxide (NO) bioavailability. NO is a potent     vasodilator that is believed to play a role in increasing blood flow to active muscle during     exercise. This regulatory process is impaired with healthy aging. The underlying premise to     this study is that if NO bioavailability can be increased following flavanol ingestion, will     there be a restoration of blood flow during exercise in older individuals? Accordingly, the     first part of this research project will compare the acute vascular effects of flavanol     ingestion between a young and old group. The investigators have hypothesized that both groups     will show an improvement in blood flow to active muscle during exercise, though the magnitude     of the change will be greater in the older group. The second part of this project will look     at the effects of 4 weeks of daily flavanol ingestion in the old group. The investigators     hypothesize that subjects will demonstrate an improvement in blood flow to active muscle     during exercise after the 4 week intervention and that the magnitude of the change will be     greater than the acute effects. Findings from this proposal will provide evidence for the     efficacy of flavanols to be used (as a simple and safe lifestyle intervention) to reverse or     combat impaired blood flow regulation in older individuals.   "
131979|NCT01557725|"     There are many different views regarding ideal duration and type of thromboprophylaxis after     hip or knee surgery.      An important factor in Fast-track surgery is early mobilization, which in itself is thought     to prevent clotting.      The investigators hypothesize that there is no increase with regards to thrombosis in     patients receiving fast-track surgery with early mobilization and chemical thrombosis     prophylaxis only during hospitalization.   "
131980|NCT01557712|"     The objective of this study is to evaluate the effectiveness of ketamine (infusion of     0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major     depression (MADRS score ≥ 20 ) to six weeks of treatment.   "
131981|NCT01557699|"     This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be     given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV     by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will     be followed for 180 days for safety.   "
131982|NCT01557686|"     The purpose of this pilot study is to test an exercise-based multidimensional intervention     for patients with acute leukaemia undergoing consolidation chemotherapy in the context of     outpatient management. Further, to test for safety, feasibility and preliminary effect on     physical and functional capacity, and health related quality of life.   "
131983|NCT01557673|"     Following surgery some patients are unable to swallow. For those requiring nutritional     support a tube is sometimes passed through the nose into the stomach to provide feeding.     Traditionally this type of feeding is given slowly over the course of the day. However, it is     thought that this mode of feeding might increase the amount of fluid entering the bowel     contributing to symptoms of diarrhoea. An alternative strategy of feeding, given in larger     volumes in a shorter space of time resembles normal feeding patterns and may reduce the     amount of water entering the bowel.      In this study we want to use a non invasive medical imaging technique called magnetic     resonance imaging (or MRI) to look at the volume of bowel water following these two feeding     strategies in 12 healthy volunteers.      Each volunteer will have a tube inserted into the stomach via the nose and undergo the two     feeding strategies at least 7 days apart. We will take repeated images using the MRI scanner     to assess the bowel response and some samples of blood are required for analysis of blood     sugar.   "
131984|NCT01555476|"     This study is designed to assess bioequivalence between one test and one reference     formulation used for temporary relief of pain. The results will help decide if the new     medicine is likely to provide pain relief similar to the product being sold.   "
131985|NCT01555463|"     The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam,     15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea     compared to its vehicle.   "
131986|NCT01555450|"     Variations in participation to the colorectal cancer screening seems to reveal social and     geographical inequalities. Our study will investigate whether patient navigation could     increase the participation to the colorectal cancer screening and in the same time, reduce     the social inequalities.   "
131987|NCT01555437|"     Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical     presentation can vary considerably. Patients are frequently assessed by capsule endoscopy     (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the     correlations between CE scoring index (CESI), biological markers, and disease activity     indices remain undefined.      Methods: A prospective study was conducted between October 2008 and February 2011 on 58     established SBCD patients and suspected patients who received a definitive SBCD diagnosis     during study. Patients underwent complete CE, and were scored according to the CESI     (inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and     Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein     (CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the     patients underwent CE with scoring for CESI, HBI, and CRP.   "
131988|NCT01555424|"     The investigators hypotheses is that the consumption of the investigators vitamin D fortified     cheese will result in an increase in serum 25-hydroxy vitamin D levels in older     institutionalized adults. Also, the consumption of the cheese with the higher amount of     vitamin D will result in an improvement in wellbeing scores.   "
131989|NCT01555411|"     Akershus Cardiac Examination (ACE) 1950 Study will be a large, observational, prospective,     longitudinal, population-based cohort study. The overall aim is to establish an extensive     cardio- and cerebrovascular age cohort of elderly subjects for various longitudinal long-term     follow-up studies of cardiovascular and cerebrovascular disease.   "
131990|NCT01555398|"     The purpose of this study is to evaluate the effect of food on the pharmacokinetic     characteristics of fenofibric acid for HIP0901 capsule.   "
131991|NCT01557660|"     Open-label extension of RIN-PH-302.   "
131992|NCT01557647|"     To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and     time to clinical worsening.   "
131993|NCT01557634|"     The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid     increase in preschool children. Intensive control of blood glucose levels, although essential     to protect against onset and progression of diabetes-related complications, faces unique     challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of     insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of     hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an     insulin pump and a computer-based 'model predictive algorithm', which calculates the amount     of insulin to be given by the insulin pump according to the CGM values. In the studies     performed thus far the efficacy and safety of closed-loop glucose control were evaluated in     children and adolescents aged 6 to 18 years. The results showed that closed-loop improved     control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the     conventional insulin pump therapy. The objective of the current study is to extend the     evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great     benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period     cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be     compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D.     Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical     research facility, during which glucose levels will be controlled by either the     computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard     insulin. On both occasions, participants will receive a self-selected evening meal and     closed-loop will run from 17:00 until 08:00am the following day. The study will take place at     the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from     paediatric diabetes clinics in England.   "
131994|NCT01557621|"     The purpose of this study is to determine if a collaborative centralized population-based     reminder/recall intervention is more effective than a traditional practice-based     reminder/recall intervention at increasing immunizations among young children.   "
131995|NCT01557608|"     Numbness, tingling, and pain in the hands and feet following the administration of     chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in     oncology patients. However, more information is needed on why patients develop neuropathy and     how it impacts their mood, ability to function, and their quality of life. In addition,     effective treatments for this problem are not available at the present time. This study will     be conducted in two parts. In Part 1, patients who have finished chemotherapy and did or did     not develop CIN will be evaluated to determine why some patients do and other patients do not     develop CIN. In addition, the impact of CIN on patients' mood, function, and quality of life     will be evaluated by comparing patients' reports on these important outcome measures. In     addition, genetic markers that contribute to or protect against the development of CIN will     be evaluated. Part 2 of this study will test the effects of a new treatment called photon     stimulation (also called infrared light therapy) compared to placebo treatment to improve     sensations in the feet of oncology patients with CIN. Patients who receive the photon     stimulation will have greater improvement in sensation in their feet compared with those who     do not receive photon stimulation.   "
134243|NCT01527721|"     Primary objective of this study was to assess the impact of the two prevalent therapeutic     options, CxL and CxL combined with topography-guided photorefractive keratectomy (t-PRK), on     both anterior and posterior corneal High order aberations (HOAs).   "
131996|NCT01557595|"     Patients with ADHD often report staying up late on the computer, watching TV, or using other     electronic devices, all strong emitters of blue light which may be contributing to the     delayed sleep onset times seen in some of these patients. Evening use of polarizing glasses     which filter out blue light may decrease the contribution of environmental light late at     night to delayed bedtime. This is a treatment that Dr. Fargason uses when patients do not     want to use sleep medication to help them fall asleep. The purpose of this study is to     evaluate the effectiveness of this treatment by use of sleep diaries and sleep     questionnaires.   "
131997|NCT01557582|"     The primary endpoint of this study is the percent difference between the VentriPoint Medical     System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular     volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial     will be defined as positive if the mean VMS-cMRI percent difference is <10% and >-10% at a     1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns     for the VMS procedure.   "
131998|NCT01557569|"     The purpose of this study is to examine the ability of atomoxetine compared to placebo to     increase time to relapse in methamphetamine dependent volunteers. Our hypothesis is that     atomoxetine will increase time before (if) the participant relapses.   "
131999|NCT01557556|"     Background:      - Stressful situations often cause tobacco cravings. These cravings can make it very     difficult for smokers who are trying to quit. Research has shown that craving may involve     hormone pathways in the brain. The anti-anxiety drug pexacerfont acts on these hormone     pathways. Researchers want to see if pexacerfont can act on the brain and lessen     stress-related tobacco cravings in smokers who are trying to quit.      Objectives:      - To test the effects of pexacerfont on tobacco craving in smokers who want to quit smoking.      Eligibility:      - Smokers between 18 to 55 years of age who are trying to quit. (Participants must have     smoked at least 10 cigarettes per day for at least 1 year.)      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will be assigned to take either pexacerfont or a placebo. They will take          three pills every morning for the first 7 days, then one pill every morning for 23 days.        -  At the first visit, participants will provide blood and urine samples. They will then be          asked to prepare a 5-minute speech and give it to the study researchers. They will also          be asked to do mental math problems for another 5 minutes. During these tests, blood          pressure, heart rate, sweating, and skin temperature will be measured. Participants will          fill out questionnaires about stress levels, tobacco cravings, and personal experiences.        -  Participants will take the study pills for 30 days. Before the 2-week point,          participants will be asked to try to quit smoking for 2 weeks.        -  Participants will have four study visits. These visits will involve brain imaging scans          and emotional stress tests. Tobacco cravings and other stress levels will be measured at          each study. Blood and urine samples may be collected at these studies.        -  Participants will have follow-up visits and phone calls for up to 6 months after the end          of the study visits.   "
132000|NCT01557543|"     Background:      - Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated     and are found to make large amounts of growth factors. Because they make growth factors,     these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged     heart muscle suggest that injecting these cells directly into damaged heart muscle can     improve heart function. Researchers want to give stem cells to people who are having open     heart surgery to see if they can help to repair heart muscle damage.      Objectives:      - To test the safety and effectiveness of bone marrow stromal stem cell injections given     during heart surgery to treat heart muscle damage.      Eligibility:      - Individuals at least 18 years of age who are scheduled to have open heart surgery for heart     artery or vein blockages.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will also be collected.        -  Participants will have bone marrow taken from both hip bones about 3 weeks before the          heart surgery.        -  During the surgery, the stromal stem cells collected from the bone marrow will be given          into the damaged portion of the heart muscle. The rest of the heart surgery will be          performed according to standard procedures.        -  After the surgery, participants will be monitored for complications from the stromal          stem cells.        -  Participants will have heart function tests to see if the stromal stem cell treatments          were effective.   "
132001|NCT01557517|"     Background:      - Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow     transplants. It is the result of the donor cells trying to attack the recipient s body.     Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and     painful swallowing. Steroids are a possible effective treatment for GHVD, but they can cause     side effects when given as pills or injections. Steroids given in a cream or rinse form,     applied directly to the site of the symptoms, can have fewer side effects. However, their     effectiveness as a rinse has not been tested in the mouth. Researchers want to see if a     steroid called clobetasol can be used as a mouth rinse to treat oral GHVD.      Objectives:      - To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host     disease.      Eligibility:      - Individuals at least 12 years of age who have oral GHVD and are not allergic to clobetasol.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and          other tests before starting the study drug.        -  Participants will be separated into two groups. One group will receive clobetasol; the          other will have a placebo liquid.        -  Participants will rinse their mouths with the study liquid three times a day after meals          for 2 weeks.        -  After 2 weeks, participants will have another study visit with blood tests and other          exams.        -  After the study visit, all participants will start to use the clobetasol rinse. Those          who originally had clobetasol will use the rinse for another 2 weeks. Those who          originally had a placebo will use the rinse for 4 weeks.        -  Participants will have a follow-up exam after the end of treatment....   "
132002|NCT01557504|"     The purpose of this study is to assess:        1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in          pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years        2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two          sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets          (excluding marking)        3. the pharmacokinetics of sitagliptin and metformin following the administration of two          sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged          10 to 17 years.   "
132003|NCT01557491|"     Loss of hair growth potential in long surgical scalp incisions can become obvious to the     patient and others, given hair's tendency to part along the resulting scar. Bevelling     incisions perpendicular to the hair follicle angle may increase hair growth through the scar.     However, many factors may be confounders such as wound tension and cauterizing the incision.     This study will investigate the effect a bevelled incision has on hair growth preservation     compared to a standard incision that incises the skin perpendicular to its surface     irrespective of hair follicle angles. Following informed voluntary consent, subjects who     require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The right     side of this bilateral incision will be randomized to receive either a bevelled or a standard     incision and the left side will receive the opposite type. During routine surgical follow-up     the hair growth within the scar of the two sides will be recorded for comparison and it is     our hypothesis that the side with the bevelled incision will have more hair within the scar.   "
132004|NCT01557478|"     The study evaluate the effect of melatonin in improving quality of life and reducing post     operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a     multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III     breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme     is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The     patients are required to take the studied drugs at night (after 21.00 pm) on the first night     prior to surgery and continue for 24 months. Standard treatment is surgery followed by     chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B),     pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and     progression-free survival.   "
132005|NCT01557465|"     The purpose of this study is to determine whether mechanical alternans (alternating strong     and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant     ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to     predict progression of heart failure and death.   "
132006|NCT01557452|"     Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA     through the inhibition of the production/release of pro-inflammatory cytokines, such as     IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.   "
132007|NCT01557439|"     This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this     study is to assess the bioequivalence between Test Product and the corresponding Reference     Product under fasting condition in normal, healthy, adult, human subjects.   "
132008|NCT01557426|"     Objectives:      This study aims to characterize severe skin and soft tissue infections (SSTIs) in the     emergency department through the acquisition of ultrasound images. A wide range of SSTIs will     be imaged and recorded, leading to a registry of these infections. The registry will show     whether ED (emergency department) sonographers can accurately characterize these infections,     as compared to the final hospital diagnosis. The registry will also provide data for a     case-control study comparing ultrasonographic characteristics of necrotizing skin and soft     tissue infections (NSTIs) to those of non-necrotizing SSTIs.      Research procedures:      In this study, the investigators will approach patients who present to the Emergency     Department with a possible skin and/or tissue infection. Study subjects must be ED patients     requiring admission to the hospital for the primary problem of an SSTI due to the need for     follow-up. If the patient consents to participating in the study, the investigator will     obtain and record an ultrasound image of the infected area. An ultrasound image of an     uninfected area of skin will also be recorded for comparison. Patient information regarding     personal history, physical examination, blood tests and x-rays will also be gathered from     participants.   "
132009|NCT01557413|"     Primary purpose of this study was to compare functional outcomes after displaced and proximal     humerus fracture between nails and locked plates.      The hypothesis is that intramedullary nails provides satisfactory fixation and functional     outcome compared to locked plate.   "
132010|NCT01557400|"     Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is     caused by a mutation in the gene for dystrophin, a protein that is important for maintaining     normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads     to weakness and loss of walking ability during childhood and teenage years. A specific type     of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in     approximately 10-15% of boys with the disease. Ataluren is an orally delivered,     investigational drug that has the potential to overcome the effects of the nonsense mutation.     This study is an open-label trial for patients with nonsense mutation dystrophinopathy who     received ataluren in a prior PTC-sponsored study at a clinical trial site in Europe, Israel,     Australia, or Canada. The primary objective of the study is to evaluate the long-term safety     of ataluren, as determined by adverse events and laboratory abnormalities.   "
132011|NCT01557387|"     Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds     expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could     decrease the need and expense of endoscopic biopsy for these lesions.      Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging     techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying     techniques using indigo carmine which will predict diagnosis without biopsy.      100 patients with inflammatory bowel disease will be enrolled in the study. Following a     standard bowel preparation, each patient will be evaluated using standard endoscopic     equipment. All patients will receive a standard bowel preparation (sodium phosphate,     PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be     performed for indications unrelated to the present study, including evaluation of response to     medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal bleeding.     Polypoid lesions will be examined using four consecutive methods: (a) high definition white     light, (b) narrow band imaging, (c) chromoendoscopy (high definition white light with indigo     carmine dye-spraying), and (d) histologic examination following biopsy. The flat mucosa     surrounding the polypoid lesions will also be examined using theses four techniques in an     effort to identify dysplastic tissue associated with these polypoid growths.      High definition white light is the standard imaging modality used for colonoscopy. Narrow     band imaging (blue wavelength of light) is also used routinely and is available on all     current generation colonoscopes with the press of a button. Our division routinely uses     chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel     disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa.     The dye used will be indigo carmine.      Directed biopsy specimens will then be performed using a multibite forceps for targeted     biopsies. Routine biopsies will be performed as clinically indicated. Pathology slides will     be reviewed by the gastrointestinal pathologists at the University of Miami. The     gastroenterologist's interpretation based on each of the three successive endoscopic methods     will then be compared to the histologic evaluation with each individual lesion serving as its     own control.   "
132012|NCT01557374|"     Ever since the biotherapy agents have entered the market, the recommended therapeutic     objective in Rheumatoid arthritis, has been remission. Once obtained, it is advised to try to     reduce or cease these biotherapy agents, for which, their efficacy is counterbalanced to     their tolerance in the medium and long term as well as their high price. Nevertheless, we do     not dispose considerable data on the risks of relapse or structural progression during such a     step down strategy. A few studies on anti-TNF agents have shown the possibility of such     therapy reduction. A national study,  STRASS , coordinated by Bruno FAUTREL, has evaluated     the possibility of spacing or even stopping the injections of anti-TNF(s). To date, no data     concerning Abatacept or Tocilizumab has been published.      As the expected result, this study is aimed to test the feasibility of a step down strategy     on 2 biological agents, Abatacept and Tocilizumab, in RA patients in remission.   "
132303|NCT01553240|"     This study uses functional brain imaging and noninvasive brain stimulation techniques to     study the brain basis of developmental disorders like Autism Spectrum Disorder and Asperger     Disorder. Functional magnetic resonance imaging (fMRI) and recently approved FDA treatment of     depression, Transcranial magnetic stimulation (TMS) will be used to study the neurocircuitry     of certain symptom clusters in developmental disorders.   "
132013|NCT01557361|"     The objectives of this trial are to determine whether, in critically ill patients with severe     acute kidney injury (AKI), randomization to accelerated initiation of renal replacement     therapy (RRT), compared with standard initiation, is:        1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates,          and achievement of follow-up; and        2. Safe, from the perspective of potential adverse events associated with earlier          initiation of RRT   "
132014|NCT01557348|"     This multicenter, prospective, observational study will assess the efficacy of     MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid     arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will     be collected from each patient from the time of change in biologic therapy for 12 months.   "
132015|NCT01557335|"     This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel     dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel dosed     concomitantly.   "
132016|NCT01557322|"     1. To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world          setting across two moderate RA cohorts: a Test Group of patients newly exposed to          etanercept (Enbrel) therapy and a Control Group of patients with similar disease          characteristics newly exposed to other, non-biologic therapies.        2. To assess the change over time (from baseline to the most recent follow-up) in the          characteristics described at baseline in 2 British Society for Rheumatology Biologics          Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying          anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).   "
132017|NCT01557309|"     The optimal timing for surgical repair of traumatic rotator cuff tears is controversial.     Today there are no prospective studies investigating the short to mid-term outcome after     early arthroscopic repair of traumatic rotator cuff tears and the Swedish National     Musculoskeletal Competence Centre requests more research to this subject. The investigators     will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair     during the first year after surgery.      The investigators hypothesise that the outcome after rotator cuff repair is good.   "
132018|NCT01557296|"     The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2     and gastroparesis:        -  validate radiopaque markers with fluoroscopy with gastric scintigraphy method        -  study the difference of metabolic control including the frequents of hypoglycaemia,          gastrointestinal symptoms, quality of life and nutrition state during dietary treatment          of food of small particle size compared with food of large particle size        -  validate the radiopaque markers method and measurement of the blood glucose and          gastrointestinal symptoms after a test meal, against the gastric scintigraphy        -  determine if the function of gastric emptying can be improved after intervention   "
132019|NCT01557283|"     With the new reimbursement criteria, we want:      To describe the average treatment duration of patients with Enbrel expressed as a number of     weeks/year.      To describe the number of patients who receive continuous treatment To describe the number of     patients who receive intermittent treatment To describe the number of weeks off treatment   "
132020|NCT01557270|"     The purpose of this study is to test the efficacy and safety of dexmedetomidine added to     ropivacaine in patients undergoing shoulder surgery.   "
132021|NCT01557257|"     To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the     administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice     Daily in Healthy Volunteers   "
132022|NCT01557244|"     The objective of the study is to find out if the medicine fesoterodine is a useful treatment     in children with bladder muscle overactivity caused by a neurological condition. Children     will be aged 6 to 17 years old. This is done by finding out how well it works, what the body     does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It     will be compared with the medicine oxybutynin, which is already available for treating the     condition.   "
132023|NCT01557231|"     Chronic pain, by definition, persists over long periods of time, but both sufferers of pain     and their caregivers are aware that pain levels can fluctuate greatly over time. Being able     to define pain variability and its underlying causes would be an important advance in our     understanding of chronic pain, and would in turn lead to better approaches to the treatment     of chronic pain. In this study, the investigators propose to evaluate in 60 people with     chronic pain of the knee due to osteoarthritis over 3 months, collecting data regarding     magnitude of pain, physical activity level, and medication status twice daily during this     period of time. The investigators then will assess the variability in pain levels over time,     the frequency of flares of osteoarthritis (OA) pain and their relationship to physical     activity, medications, and clinical descriptors of the population, e.g., age, gender, body     mass index (BMI). Additionally, evaluations will be made regarding temporal patterns of OA     knee pain as well as assessment of subgroups of patients with the overall group being     studied.   "
132024|NCT01557218|"     Intake of vegetables and fruits in preschool children is less than recommended amounts.     Although offering a variety of foods has been shown to increase intake, this effect has not     been well studied for low-energy-dense foods. The purpose of this study was to test whether     increasing the variety of vegetables and fruits served to preschool children affected the     amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would     increase both the amount selected and the amount eaten.   "
132025|NCT01557205|"     The investigators will obtain human skin specimen (sized approximately 1 cm x 1 cm) for     dermatological surgical patients in National Taiwan University Hospital, after informed     consent was obtained. Human skin keratinocytes, fibroblasts, and melanocytes will be cultured     from the human skin specimen. The three dimensional images of these cultured cells will be     observed by a ultra-high resolution 3-dimensional optical coherence tomography.   "
132026|NCT01557192|"     To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS)     as an antidepressant treatment in subjects with mood disorders.   "
132116|NCT01556061|"     The investigators hypothesize that the D-MAC (Dblade with C-MAC system) may be a suitable     alternative device for difficult laryngoscopy and tracheal intubation in morbidly obese     patients. The D-MAC will enable superior view of the glottic structures as well as easier     endotracheal intubations than the C-MAC blade. This is the first study to investigate the     individual and comparative performances of C-MAC and D-MAC in this patient cohort.   "
132027|NCT01557179|"     This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place     at four centers in China. The primary objective of this study was to assess the efficacy and     safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we     tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to     that of estriol cream, with no clinically significant difference between them, in the     treatment of vaginal dryness symptoms.   "
132028|NCT01557166|"     This trial is conducted in North America. The aim of the trial is to investigate the effect     of liraglutide in obese subjects with sleep apnoea.   "
132029|NCT01557153|"     Depression has a high occurrence and causes other problems in older people, two thirds of     these patients will not have a lessening in their condition from routine treatment     medication. About half have a form of depression known as 'vascular depression'.     Augmentation, the addition to, antidepressant treatment with a vascular type of treatment     (such as a group of medications called Calcium Channel Blocker including the medication     called amlodipine) may be effective in this group of patients but previously published     studies have been from highly selected specific patient groups. The investigators would like     to find out if giving amlodipine medication to people with late life non-responding vascular     depression would be acceptable to this patient group. The investigators would also like to     know how they feel while having the treatment and whether this provides a measurable benefit     for those patients and whether those benefits are relevant to the patients. The investigators     would also like to find out the information the investigators need to plan and prepare for a     larger version of this study.   "
132030|NCT01557140|"     Chronic Chagas cardiomyopathy causes substantial morbidity and mortality in Latin America.     Whether RAS inhibitors and beta-blockers are safe and beneficial has been challenged because     of the lack of formal trials. Hence, the objective of this study was to determine the safety     and efficacy of renin-angiotensin system (RAS) inhibitors and beta-blockers in chronic Chagas     cardiomyopathy. This way, the investigators conducted a double-blind, placebo-controlled, and     randomized trial in 42 patients with Trypanosoma cruzi infection and cardiomyopathy. All     patients received enalapril (up-titrated to 20 mg BID) and spironolactone (25 mg QD).     Subsequently, the patients were randomly assigned to receive placebo (n = 20) or carvedilol     up-titrated to 25 mg BID (n = 19). The primary end points were change in left ventricular     ejection fraction (LVEF) after RAS inhibition and that after the addition of carvedilol. The     secondary end points were changes in other echocardiographic parameters, Framingham score,     quality of life (36-item Short-Form Health Survey), New York Heart Association class,     radiographic indices, brain natriuretic peptide levels, and chemokines as well as safety end     points.   "
132031|NCT01557127|"     This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate     the actual dosing of Nexavar in real-life setting vs. the prescribed dose.   "
132032|NCT01557114|"     RATIONALE:Anti-melanoma activity of Ipilimumab both as a single therapy and in association     with melanoma peptides has been shown as well as synergy between radiation therapy and     anti-CTLA-A mAb in several tumor animal models for both local tumor control and distant     effects.Radiotherapy increases tumor immunogenicity in several preclinical models by     increasing MHC molecules expression and is able to induce significant tumor reduction in     around 30% of cases. Thus, combining radiotherapy and administration of ipilimumab could     elicit systemic antitumor response. Radiation therapy will expose tumor-associated antigens     (TAA) and facilitate antigen presentation, and further blockade of CTLA-4 could amplify the     immune antitumor response. In this therapeutical model, the use of the own patient tumor as a     source of tumor antigens (in opposition with other vaccination protocols, where TAA are     exogenic) is particularly adapted.      PURPOSE: This Phase I trial determines the side effects and best dose of radiation therapy     administered in combination with ipilimumab.   "
132033|NCT01557101|"     The purpose of this study is to determine if the adherence to screening in first grade     relatives of patients with CCR is higher than optical colonoscopy.   "
132034|NCT01557088|"     The majority of the acute coronary events are caused by coronary artery segments with minimal     luminal disease, but with potentially significant vascular wall inflammation and oxidative     stress leading to plaque vulnerability. It has become apparent that an initial injury at the     endothelial surface, is the primary site of the mechanisms involved and a role for vascular     inflammation and the interaction with oxidative stress continues to emerge.     Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a novel biomarker for vascular wall     inflammation that circulates in the blood bound to both low density (LDL) and high density     (HDL) lipoprotein and promotes vascular inflammation. Circulating levels of Lp-PLA2 mass and     activity are an independent risk factor for cardiovascular events. Recent studies,     demonstrating that Lp-PLA2 is also associated with coronary endothelial dysfunction. However,     the relationship between Lp-PLA2 and early atherosclerotic changes in the coronary arteries,     and the contribution of lipoprotein binding to the deleterious potential of Lp- PLA2 have not     been elucidated. Our working hypothesis is that the endogenous local activation of the     Lp-PLA2 pathway plays an integral role in early coronary atherosclerosis and contributes to     the mechanism of coronary endothelial dysfunction and the structural and mechanical     properties reflecting plaque vulnerability. Thus, the current application will characterize     prospectively the correlation between the functional, mechanical, and structural vascular     wall properties, and the systemic as well as the coronary activity of the Lp-PLA2 pathway.   "
132035|NCT01557075|"     The purpose of this study is to determine whether high dose statin therapy in patients with     aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and     were free of the adverse cardiac events during the first 12 months could be superior over     pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events     during the additional 12 months.      Study Design.   "
132065|NCT01556737|"     Alleged benefits experienced after the consumption of soy in Asian countries have been     attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are     believed to relieve menopausal symptoms and are therefore often consumed in supplement form     in Western countries. These supplements contain relatively high amounts of isoflavones and     are on the market in different compositions. The question is whether supplements with     different compositions exert similar effects or whether the effects differ substantially.   "
132036|NCT01557062|"     Objectives: To assess the effect of passive body heating on the sleep pattern of patients     with fibromyalgia.      Methods: Six menopausal women diagnosed with fibromyalgia according to criteria determined by     the American College of Rheumatology were included. All women underwent passive immersion in     a warm bath at 36±1 °C, for 15 sessions of 30 minutes each over 3 weeks. Their sleep pattern     was assessed by polysomnography at the following conditions: pre-intervention (baseline), on     the first day of intervention (acute), on the last day of intervention (chronic) and 3 weeks     after the end of interventions (follow-up). Core body temperature was evaluated by a     thermistor pill at the above-mentioned conditions. The impact on fibromyalgia was assessed     through of a specific questionnaire called fibromyalgia impact questionnaire.   "
132037|NCT01557049|"     The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation     (GPR) program in subjects with chronic low back pain.   "
132038|NCT01557036|"     The primary objective of this study is to further expand the body of clinical knowledge in     patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial     aneurysms (IAs or ICAs) according to Pipeline's labeled indication.   "
132039|NCT01557023|"     This trial will study the percentage of women with at least one occurrence of intracyclic     bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or     reference drug.   "
132040|NCT01557010|"     The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in     Postherpetic Neuralgia.   "
132041|NCT01556997|"     The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination     drug compared to two other drugs (monotherapies) in controlling hypertension.   "
132042|NCT01556984|"     Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators     hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In     this study, the investigators will select 200 diabetic patients who have a DSA for diabetic     foot screening. Also, the investigators will select 100 healthy subjects as controls. The     endothelial function will be determined by high resolution ultrasound before and after DSA.     The investigators will observe the changes of endothelial function after DSA assay.   "
132043|NCT01556971|"     The objective of this proposed study is to obtain data on the efficacy of Botox in reducing     symptoms of MDD in male and female patients between the ages of 18 and 65 years old.      The secondary object is to visually assess each patient's frown before and after the Botox     injection to determine if there is a correlation between changes in the frown and changes in     mood. The patients will be photographed at screening, visit 2 and 3. Their frown lines will     be compared to determine if there is a visible improvement in the frown lines corresponding     to an improvement in the efficacy rating scores.   "
132044|NCT01556958|"     The primary goal of the study is to more firmly establish correlations between     WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry,     provider's auscultation, and symptoms at the time of Wz% measurement.   "
132045|NCT01556945|"     The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS,     combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are     safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines     can prevent malaria infection.      The RTS,S vaccine contains a malaria protein in combination with a portion of the     commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein.     The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study     days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd     vaccination.   "
132046|NCT01556932|"     This randomized clinical trial studies ABH (lorazepam, diphenhydramine hydrochloride, and     haloperidol) gel in patients with nausea. ABH gel, when absorbed into the skin, may be an     effective treatment for nausea and vomiting. The general purpose of this research study is to     improve the treatment of nausea and vomiting.   "
132047|NCT01556919|"     The investigators are looking at a novel approach to measuring gastroesophageal reflux     disease (GERD) damage and reducing the need for costly and less optimal testing presently     used for diagnostic and treatment purposes. The investigators will be using three custom     mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on     the esophagus.   "
132048|NCT01556906|"     The primary objective of this study is to evaluate the safety and tolerability of 4 doses of     lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an     additional 3 dose levels over a 16-week period.      The secondary objectives of this study included the evaluation of the pharmacodynamics of     lomitapide based on:        -  Percent change in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC),          triglycerides, and very low density lipoprotein cholesterol (VLDL-C) concentrations at          the end of each 4-week dosing period compared to the Baseline value of each parameter at          the end of the previous dose phase(s).        -  Changes in other plasma lipoproteins: apolipoproteins (apo B, apo AI, apo AII, apo CIII,          apo E) and lipoprotein a [Lp(a)].   "
132049|NCT01556893|"     This will be a prospective, single-center clinical trial of up to 50 eyes of subjects     scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be     screened for eligibility.      Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to     excimer laser treatment.      Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the     stromal bed quality, and the amount of opaque bubble layer. All patients will be followed     with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity,     manifest refraction, slit lamp examination, and endothelial cell counts.   "
132050|NCT01556880|"     The purpose of this study is to prevent the professional drivers from pre-diabetes to     diabetes.   "
132090|NCT01556412|"     Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically     affecting middle aged men and is frequently associated with inflammatory bowel disease.     Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical     challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography     (ERC) or percutaneous liver biopsy are needed when magnetic resonance     cholangiopancreaticography remains inconclusive. As these procedures are associated with     significant risks for the patient, the goal of this study is to evaluate, if endoscopic     ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.   "
132051|NCT01556867|"     At birth, the umbilical cord is cut, separating physically and symbolically the mother of his     child. Before cord drop, umbilical area is a possible way of bacterial infection. Thus,     umbilical cord infections constitute a major cause of neonatal morbidity and mortality in     developing countries. In industrialized countries, omphalitis cases have almost disappeared     whatever cord care strategies. At this day, care practices appear extremely different between     countries, based more on habits and convictions that on evidence-based medicine. The     investigators propose to conduct a non inferiority multicenter clustered crossed randomized     study. Observations sessions will be performed on two consecutive periods of 5 months: 4     months of recruitment and 1 month follow-up. Main objective is to demonstrate that dry cord     care practice would not expose to a higher risk of omphalitis than antiseptic based care     approach. The purpose of NEOCORD study is a simplification of cord care for paramedical teams     and parents, but also a significant reduction of costs in a medico-economic approach.   "
132052|NCT01556854|"     The primary objective of this study is to compare effectiveness of five different     neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and     piracetam, among patients with acute ischemic stroke.      The secondary objectives of the study are as follows:        -  To compare safety of five different neuroprotectents, including butylphthalide,          edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic          stroke.        -  To compare cost-effectiveness of five different neuroprotectents, including          butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with          acute ischemic stroke.   "
132053|NCT01556841|"     The purpose of this trial is to assess the effectiveness of TroVax® compared to placebo in     extending the time to progression in patients with asymptomatic relapsed platinum resistant     ovarian, fallopian tube or primary peritoneal cancer.The trial will also look at overall     survival times and quality of life.   "
132054|NCT01556828|"     The goal of this study is to identify genetic changes associated with the initiation,     progression, and treatment response of response of cutaneous and hematologic disorders using     recently developed high-throughput sequencing technologies. The improved understanding of the     genetic changes associated with cutaneous and hematologic disorders may lead to improved     diagnostic, prognostic and therapeutic options for these disorders.   "
132055|NCT01556815|"     Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular     carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release     of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell     proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may     benefit from sorafenib in combination with TACE.   "
132056|NCT01556802|"     The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in     patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five     days, then perform periodic evaluations to determine the status and degree of neurological     sequelae developed.   "
132057|NCT01556789|"     Open label, two part, Phase 1 dose escalation study to evaluate the safety and immunogenicity     of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid     tumors. Part 1 to evaluate escalating dose levels of ONT-10 administered subcutaneously every     two weeks (Q2W) or weekly (QW) over 8 weeks. Part 2 evaluates the safety, immunogenicity, and     potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW maximum     tolerated does/recommended dose (MTD/RD) in cohorts of 15 patients each.   "
132058|NCT01556776|"     CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group     study that compares the efficacy and safety of oral lenalidomide maintenance therapy to that     of placebo maintenance therapy in high-risk subjects with Chronic Lymphocytic Leukemia (CLL)     who have achieved at least a partial response (PR) and either:        -  MRD levels of ≥ 10-2 or        -  MRD levels of ≥ 10-4 - < 10-2 combined with at least one of the following factors:             -  an unmutated IGHV-status             -  17p-deletion or             -  TP53 mutation after first line therapy with FCR, FR, BR or FC (in case of of               contraindications to receive Rituximab).   "
132059|NCT01556763|"     This study in patients with schizophrenia is designed to provide preliminary evidence of the     safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2     doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic     medication.   "
132060|NCT01555385|"     The aim of the study is to investigate the influence of nutritive (high-protein or     high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and     physiological responses of mental workload during multitasking in healthy volunteers.   "
132061|NCT01555372|"     The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking     Plate (LP) reduces the postoperative complications and leads to a better functional recovery     after unstable distal clavicle fractures (Neer 2b).   "
132062|NCT01555359|"     Autologous hematopoietic cell transplantation (HCT) is a treatment strategy used as advanced     line therapy for different malignancies, mainly hematological. Its main advantage lies in the     ability to provide hematologic and immune rescue after high dose chemotherapy therapy. The     first requirement of a successful transplantation is recruitment of sufficient amount of     cells. This is achieved by mobilizing CD34+ stem cells from the bone marrow to the peripheral     blood, by G-CSF priming, and then harvesting the cells from the peripheral blood at the right     timing by means of apheresis. Currently, the decision on the optimal collection timing is     based on the pre-collection CD34 cells blood concentrations.      The investigators goal is to investigate whether telomerase, the telomere elongation enzyme,     which constitutionally and solely expressed in progenitor cells, is correlated with     collection and post HCT engraftment characteristics.      The investigators will collect blood from patients when starting GCSF and on the day of     planned apheresis. Pearson correlation test will be used to correlate between telomerase     activity in the samples and with collection and engraftment characteristics.   "
132063|NCT01555346|"     Whole blood samples will be collected from high-risk pregnant women to validate the clinical     performance of the SEQureDx Trisomy 21 Test.   "
132064|NCT01555333|"     This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are     currently participating in Protocol 2202 into a long-term study in which all subjects will     receive active drug (arbaclofen).   "
132066|NCT01556724|"     Peripheral nerve blocks are the standard of care for pain management after hip replacement     surgery at UPMC Shadyside. This prospective, randomized study is intended to assess the     effect of 0.1 versus 0.2% ropivacaine in lumbar plexus nerve catheter infusions after total     hip arthroplasty. Ropivacaine peripheral nerve block infusions have been utilized as the     standard of care at UPMC Shadyside for many years. Ropivacaine, a less potent left-isomer of     bupivacaine, is often used in place of bupivacaine due to less motor blockade and less severe     cardiovascular and central nervous system potential toxicity.      The primary goal of this study to examine the effect of a low concentration infusion of     ropivacaine (0.1%) on postoperative analgesia (evaluated by opioid consumption after 36     hours) compared with the standard accepted concentration of 0.2% ropivacaine in lumbar plexus     catheters after primary total hip arthroplasty. Secondary goals are to examine motor     function, VAS scores and patient satisfaction with pain control in low concentration 0.1%     ropivacaine compared with 0.2% ropivacaine lumbar plexus infusions upto 36 hours after     primary total hip arthroplasty.   "
132067|NCT01556711|"     The objectives of the study are to document device performance with respect to the primary     and secondary endpoints.   "
132068|NCT01556698|"     The primary objective of this study is to compare the tolerability, safety and efficacy of     NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to     severe acne vulgaris.   "
132069|NCT01556685|"     This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine the     frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the long     term retrospective observational evaluation conducted to measure efficacy, adherence to     therapy, tolerability, and safety in subjects with relapsing MS related to antibody status     and treatment.   "
132070|NCT01556672|"     This study will determine the prevalence of small bowel lesions suggestive of Crohn's disease     (CD) in patients with moderate to severe plaque psoriasis using capsule endoscopy. The study     also aims to determine if the treatment of psoriasis with adalimumab will have an effect on     the healing of the small bowel for patients who have lesions suggestive of CD.      Patients with psoriasis are at increased risk of developing Crohn's disease (CD), but the     exact prevalence of CD in patients with psoriasis at this time is unknown as many patients     probably have undiagnosed disease as the early signs will often cause no symptoms. CD is     therefore receiving very little attention from dermatologists who are treating patients with     psoriasis. For example, very few dermatologists will actively question patients with     psoriasis about symptoms of CD. This lack of knowledge may induce delays in diagnosis. By the     time the diagnosis is made and patients receive their first treatment, they may already have     significant fibrosis and stenosis of the intestine. Current treatments, including adalimumab,     cannot reverse small bowel anomalies to normal in the presence of fibrosis. Therefore, many     patients with a late diagnosis will still have symptoms or will eventually require surgery     despite good control of the inflammation. Treatment of CD should start as early as possible,     as early treatment has been associated with an increased rate of complete healing. Complete     control of the disease at its early stages may prevent complications.   "
132071|NCT01556659|"     Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST     segment elevation myocardial infarction (STEMI). It is a feared complication since it might     increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K     antagonist treatment in these patients. However patients with STEMI nowadays undergo primary     percutaneous coronary intervention (PCI) with coronary stent placement and consequently     require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis.     Consequently, STEMI patients with LV thrombus are currently treated with triple     antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K     antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly     increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as     compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral.     The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not     show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy     to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality     due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to     address this issue.      Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of     the study is to determine in a randomized fashion the risks and benefits of the addition of     vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients     with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline     Magnetic Resonance Imaging (MRI).   "
132072|NCT01556646|"     Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality     of life in cirrhotic patients with hyponatremia   "
132073|NCT01556633|"     This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety     of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine     clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.   "
132074|NCT01556620|"     We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical,     USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra     Neurosciences, USA) and that values are correlated.   "
132075|NCT01556607|"     The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled     by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.   "
132091|NCT01556399|"     The purpose is to investigate whether polyps that look different at endoscopy, have formed     via different mutations and have different risks of turning into cancer.   "
132092|NCT01556386|"     This study is to find out distribution of genetic polymorphisms and genes related to the     chemotherapeutic drugs of ALL.   "
132156|NCT01555164|"     This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to     determine the effect of ranolazine when added to metformin on glycemic control in adults with     type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment     with stable metformin therapy in addition to diet and exercise.   "
132157|NCT01555151|"     The purpose of this study is to compare the efficacy, safety and pharmacokinetics of     Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and     adolescent patients with persistent asthma.   "
132076|NCT01556594|"     Hypoglycemia is common in people with type 1 diabetes. Mild and moderate hypoglycaemia is     normally treated by consuming oral carbohydrates. During an episode of severe hypoglycaemia     however, the person with diabetes is unable to consume carbohydrates and requires help from     another person. The current standard treatment for severe hypoglycemia is intravenous glucose     or an injection of glucagon, which causes an increase of blood glucose, which allows the     person with diabetes to recover sufficiently to consume carbohydrate.      AMG Medical is investigating a novel formulation of glucagon which may be easier to     administer than the currently available glucagon formulations.      In this study, patients with Type 1 diabetes will receive injected insulin to reduce their     blood glucose, and will then receive one of three doses of the new glucagon formulation or a     dose of glucagon for injection, and their blood glucose will be measured for 3 hours.      The study hypothesis is that the new glucagon formulation will be as effective as the current     injected formulation at raising blood glucose levels within 15 minutes.   "
132077|NCT01556581|"     The primary purpose of this study is to compare the effectiveness of two management     strategies for patients with a recent onset of low back pain (LBP). One is based on usual     care and the other is based on early access to physical therapy following a pragmatic     treatment-based classification approach. The secondary purposes are to compare the subsequent     healthcare utilization associated with two management strategies as well as to evaluate the     importance of psychosocial factors on outcomes within both groups of treatment. The overall     hypothesis guiding the study is that the additional initial treatment expense incurred by     early implementation will result in superior short-term clinical effectiveness, and will be     more cost-effective in the long-term due to reduced healthcare utilization. We will also     explore the importance of psychosocial factors on outcomes within both treatment groups,     which may provide insights for further improving treatment strategies.   "
132078|NCT01556568|"     The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK     activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk     pathway that lead to MEK activation, would be beneficial over a 6 month treatment period in     hypertrophy regression.   "
132079|NCT01556555|"     This study aim to prospectively evaluate the clinical utility of Spyglass in sclerosing     cholangitis patients undergoing endoscopic retrograde cholangiopancreaticography (ERCP).     Fifty patients with a definite diagnosis of sclerosing cholangitis and a clinical indication     for ERCP from September 2008 and onwards will be investigated with peroral cholangioscopy     using Spyglass direct visualization system. Clinical data on all patients will be collected     at time of the ERCP including information on the Primary sclerosing cholangitis (PSC) and     inflammatory bowel disease (IBD), serum liver function tests and indication for ERCP.      A structured data collection form including information on Majoie Score, macroscopic features     of the bile ducts at cholangioscopy, quality of the investigation, technical difficulties,     and an overall judgment of whether any abnormalities observed were benign or malignant was     completed by the endoscopist in conjunction with the procedure.   "
132080|NCT01556542|"     The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty     followed by nitinol stent implantation versus nitinol stent implantation in superficial     femoral artery and popliteal artery stenosis.   "
132081|NCT01556529|"     The CDRM study will evaluate a newly developed approach to improve management and secondary     prevention in diabetes care. The research will explore the impact of an medical care     intervention via a computer-assisted diabetes risk management system (CDRMS) on compliance     and outcome The focus will be on the effect on patients' diabetes and diabetes complication     risk profiles, medical effectiveness and patients- reported outcomes.   "
132082|NCT01556516|"     This study explores the outcome and effect of pregnancy on Pompe Disease. The results are     expected to guide clinicians in counseling and care of women with Pompe disease, who are     planning to become pregnant, and during the pregnancy.   "
132083|NCT01556503|"     The purpose of this study is to show how well a new device, confocal microscope, works to     detect malignant melanoma, a type of skin cancer.   "
132084|NCT01556490|"     The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable     hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All     patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.   "
132085|NCT01556477|"     The proposed phase II trial is a multicenter, randomized, open-label study that will evaluate     the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk     Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) with a karyotype including     del(5q). The primary objective will be to evaluate the efficacy in terms of response     according to International Working Group (IWG) criteria for MDS and AML after 6 cycles of     azacitidine or azacitidine + lenalidomide treatment, or at end of study if this occurs at an     earlier time point.   "
132086|NCT01556464|"     This study will test the following hypotheses:        1. Treatment of newly diagnosed Obstructive Sleep Apnea (OSA) in acutely ill patients with          auto-adjusting Continuous Positive Airway Pressure (CPAP) would result in fewer          in-hospital complications, as compared to no treatment (primary outcome).        2. Treatment of newly identified OSA in acutely ill patients with auto-adjusting CPAP would          result in shorter length of stay, lower re-admission rate, better blood pressure (BP)          control, better long term compliance with OSA treatment, as compared to no treatment          (secondary outcomes).   "
132087|NCT01556451|"     This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean     adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be     enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical     hypothesis testing will be conducted in the study.   "
132088|NCT01556438|"     The purpose of this study is to evaluate the safety and effect on the body of LY2127399 in     combination with bortezomib and dexamethasone in Japanese patients with relapsed or     refractory multiple myeloma (MM).   "
132089|NCT01556425|"     In this 5-year study, the investigators propose to evaluate the separate and combined effects     of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and     employment-based reinforcement of opiate abstinence in promoting opiate abstinence and     reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug     users.   "
132093|NCT01556373|"     This study aims to assess the effect of acute inflammation on arterial stiffness and     microcirculation. Patients with severe sepsis will be compared with age-, sex- and     cardiovascular risk factors-matched controls.      The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures     are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate,     cardiac output, left ventricular ejection fraction, systemic vascular resistances), central     hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index),     thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen,     C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of     metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).   "
132094|NCT01556360|"     The purpose of this study is to describe bone status on patients with genetic     hemochromatosis, at diagnostic time and his evolution under treatment.   "
132095|NCT01556347|"     Background: Patients may develop antibodies (human leukocyte antigen [HLA] alloantibodies) to     other human tissues via pregnancy, transfusions or previous transplantation, which limits the     ability to find an acceptable donor heart for transplantation. Such patients are at high risk     for antibody mediated rejection, graft failure, and acute rejection (i.e. death). For     successful transplantation, patients must receive organs from donors who lack the HLA     antigens that correspond to their alloantibody specificities. No successful desensitization     strategy currently exists.      Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug     approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively     eliminate or significantly reduce alloantibody levels and permit highly sensitized patients     to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and     will require re-immunization.   "
132096|NCT01556334|"     Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or     azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in     stomach upset in some patients, causing them to stop taking the medication. Therefore,     azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach     upset is not seen or greatly reduced. The goal of this study is to see if there is a     difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in     prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The     working hypothesis is that there is no difference in the clinical effectiveness between     antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging     latency in PPROM.   "
132097|NCT01556321|"     Green tea may have positive effects for weight control and on body composition via several     approaches such as a positive effect on the gut flora, a decrease in fat absorption from the     intestines and an increase in resting energy expenditure.   "
132098|NCT01556308|"     Introduction: Epidermolysis Bullosa Simplex-Dowling-Meara (DM-EBS) is a rare genodermatosis     characterized by spontaneous or post traumatic large cutaneous blisters. No curative     treatment is actually available. Some data suggest a role of inflammation in the occurrence     of blisters. The aim of this study is to study the epidermis inflammatory mechanisms in     DM-EBS.      Material and methods: A first retrospective immunohistochemical study will be led on     remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical     multicentric prospective study will be led on 8 patients older than 1 year with severe     DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In     case of flare of the disease, the liquid and the top of the blisters will be took. Samples     will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid     blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated     Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with     Luminex® technical with a multiplex targeting cytokines and chemokines. An immuno-histochemic     analysis in association with a quantitative PCR will be made on the top of the blisters. If     unknown, genotypic study will be made.      Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer     new therapeutic ways.   "
132099|NCT01556295|"     The aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior     among nurses with low back pain using validated measures and compare the findings to those     from nurses without back pain.   "
132100|NCT01556282|"     Therasphere will be administered via catheter through the Hepatic Artery to treat patients     with Hepatocellular Carcinoma and Portal vein Thrombosis.   "
132101|NCT01556256|"     This randomized trial studies how well music therapy and parents' education work in improving     communication, emotional distress, and recovery in adolescents/young adult patients     undergoing treatment for high-risk cancer and their parents. Making a music therapy video may     improve communication, emotional distress, and recovery in younger patients undergoing     treatment for cancer. It is not yet known whether music therapy and counseling for parents is     more effective than information handouts for parents in improving communication and emotional     distress in patients undergoing treatment for cancer.   "
132102|NCT01556243|"     RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and     may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays     to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that     remain after surgery.      PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy     work in treating patients with multiple ipsilateral breast cancer   "
132103|NCT01556230|"     This project is the first comprehensive prospective study of clinically non-functioning     pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of     100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and     do not require surgery; Group II will consist of 250 patients who have pituitary lesions that     are symptomatic and require surgery. Patients will be followed with a series of endocrine     laboratory testing, physical examinations, testing of quality of life and neurocognitive     function before and serially over time either during non-surgical management or after surgery     and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance     imaging (MRI) studies and visual field testing being done over time during follow up as part     of clinical care will be collected.   "
132104|NCT01556217|"     The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in the     blood and cerebrospinal fluid of healthy adult volunteers following administration of a     single dose of JNJ-39393406.   "
132106|NCT01556191|"     Lung Cancer is to become the first cause of death related to cancer in France as it's already     the case in United States. At Present, Lung Cancer in women and in men is treated similarly.     Nevertheless, numerous studies shows that lung cancer in women has specificities : at the     time of the diagnosis female patients are younger, there are less clinical signs, clinical     stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker .     Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response     rate to chemotherapy is better. Prognosis is better      Numerous hypotheses have been put forward to account for the specific characteristics of     female lung cancer described above.        -  One hypothesis is that there are different genetic anomalies in women. Some studies show          an increase of EGFR mutation and HER2 expression and a decrease of expression of repair          enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and          to chemotherapy.        -  Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer          presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle,          hormone replacement therapy. Estrogens would have a deleterious effect on cancer          incidence and on survival of lung cancer in women. Cellular and animal models show that          ER pathway is activated in lung cancer and participates in oncogenesis.        -  Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer          cell lines and mouse models.      EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib)     and in women with EGFR mutations (with gefitinib). In this study, the use of these two     treatment will be in accordance with their market authorisations.      The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to     EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates     its breakdown. It has a market authorisation in breast cancer. Furthermore the association     between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between     RE and EGFR pathways .   "
132107|NCT01556178|"     In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other     molecules such as proteins and nucleic acids. In patients with central nervous system (CNS)     and other conditions, the levels of these molecules may be altered. In several other studies     at our institution, the investigators are investigating such molecules in tumor specimens as     well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However,     these levels are difficult to interpret without comparing them to levels in patients without     CNS tumors. The investigators propose a study to collect small amounts of blood and     cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a     diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.   "
132108|NCT01556165|"     Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy     in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in     levodopa-treated PD patients with motor fluctuations.      The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety     of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.   "
132109|NCT01556152|"     Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent     injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,     and costs from a public health perspective. Painful diabetic neuropathy affects 16% of     patients with diabetes. Pharmacological agents used in the management of painful DPN mainly     include tricyclic antidepressants, selective serotonin and norepinephrine reuptake     inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and     pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of     painful DPN. Generally, the available treatment options do not give total relief, are not     effective in all patients, and only about one-third of patients may achieve more than 50%     pain relief. Hence newer therapies are required for the treatment of DPN.      This is randomized, double-blind, placebo-controlled, parallel group study. The study will     include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to     DPN for least 6 months and no greater than 5 years.      Patients will be recruited after providing written informed consent.   "
132110|NCT01556139|"     The reduction in effort tolerance as result of a decreased efficiency in ventilation is     common both in patients affected by COPD (McKenzie) and chronic heart failure (CHF) (Ribeiro,     Frankenstein). One of the most common cause is the reduced respiratory muscle strength and     endurance. Some studies have evaluated the effect of a specific training on the muscular     strength both in pulmonary (Battaglia, Powell) and cardiac patients (Winkelmann, Chiappa).     Moreover, only few studies investigated a specific training for such patients (Koppers,     Sherer) because of the complicated equipment needed to prevent hypocapnia. Up to date,     portable and economic systems for isocapnic hyperpnea have been developed for respiratory     muscle training.      Primary aim of the study was to evaluate the effectiveness of the respiratory muscle training     -by the technique of the isocapnic hyperpnea- on the effort tolerance and endurance in     patients with COPD and CHF      Secondary aims were: A.to quantify the number of patients with deficit of respiratory muscles     endurance and B.to verify different response of training between COPD and CHF patients   "
132111|NCT01556126|"     The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting     Stent, in patients comparable to the everyday's clinical practice population, with a specific     focus on diabetics, that will be part of a pre-specified study subgroup.   "
132112|NCT01556113|"     To explore whether there is a different response to omega-3 fatty acid rich diet with respect     to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the rs738409 minor     allele (GG) and the common allele homozygous (CC) of PNPLA3.      Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will     lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention     than the common allele homozygous supplementation.   "
132113|NCT01556100|"     A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of     age may be eligible for this study. Candidates are screened with a medical history and     physical examination, and blood test.   "
132114|NCT01556087|"     The investigators propose that inability to tolerate the distress of opioid withdrawal and     the negative affect associated with early abstinence are key factors in early illicit opioid     lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing     distress tolerance is designed to increase treatment adherence.   "
132115|NCT01556074|"     The primary objective of this preliminary study is to estimate sleep outcome effect sizes and     determine feasibility for a novel yoga treatment of insomnia in participants with post     traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of     sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible     mechanisms of action.   "
132158|NCT01555138|"     The purpose of this study is to compare the effectiveness and safety of indacaterol with     salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive     pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone     propionate.   "
132117|NCT01556048|"     The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed     public health problem for which are no empirically supported treatments. The purpose of this     application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well     supported, stand alone intervention for depression and recently applied to posttraumatic     stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart     access to natural rewarding contingencies and resources. The treatment focuses on promoting     stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with     pleasurable activities and significant social resources. Rumination, disengagement, and low     self-efficacy are defining features of PG. Further, in response to loss of intimates, the key     factors that differentiate resilient people from those that have difficulties adapting is the     maintenance or fast resumption of social and occupational functioning. Thus, the main     hypothesis of this study is that BA for PG will result in clinically significant reductions     in rumination and functional disengagement. This is a preliminary small-scale pilot     assessment of potential efficacy and feasibility of completing a large scale study of BA for     PG.   "
132118|NCT01556035|"     In spite of high initial response rate after a first line treatment by R-polychemotherapy,     cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the     patients with PCBCL-LT. Thereafter there is no consensus concerning patients care:     radiotherapy has only a palliative effect, advanced age often limits using more aggressive     chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing     cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an     antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties.     Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells     lymphomas, especially of nongerminal cells phenotype. By analogy with these results,     lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a     manageable toxicity even in advanced age patients.      If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its     evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.   "
132119|NCT01556022|"     This is a prospective, randomized, placebo-controlled, double blind safety and feasibility     clinical trial.   "
132120|NCT01556009|"     The purpose of this study is to evaluate and compare the safety and efficacy of intermittent     vismodegib and of Photodynamic Therapy (PDT).   "
132121|NCT01555996|"     This is a randomized, controlled trial to compare the efficacy of two strategies of     non-pharmacological prevention of delirium in critically non-ventilated older patients:        -  standard non-pharmacological prevention        -  intensive nonpharmacological prevention (standard non-pharmacological prevention plus          early and intensive occupational therapy).   "
132122|NCT01555983|"     This study will demonstrate that vaporized marijuana results in antinociception when compared     to placebo in subjects with spinal cord injury. To further evaluate potential benefits and     side effects, the effect of different strengths of cannabis on mood, cognition, and     psychomotor performance will also be measured.   "
132123|NCT01555970|"     The primary objective of this study is to determine if N-Acetylcysteine (NAC) has efficacy as     an augmentation agent in the treatment of treatment-resistant obsessive-compulsive disorder     (OCD). The investigators predict that NAC will reduce OCD symptoms after sixteen weeks of     add-on treatment as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).   "
132124|NCT01555957|"     The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in     late preterm and term neonates with major GI surgical disorders   "
132125|NCT01555944|"     This is an open, multicentre, prospective observational (non-interventional) study, performed     in Belgium.      Principal objectives:        1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as          routinely evaluated) before treatment with anthracyclines of patients with metastatic          breast cancer (MBC) aged > or = 65 years        2. To observe the management of cardiovascular risk during and after anthracycline          treatment        3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac          function, outcome and quality of life (EORTC QLQ-C30)      Secondary objectives:        1. To evaluate the efficacy of anthracyclines on progression free survival and tumor          response as routinely measured (e.g. recist criteria, tumor markers and other exams)        2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection          fraction, heart failure and rate according to allocated treatment.        3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30          criteria or Karnofsky index is achieved in the various patient subgroups        4. To correlate the therapeutic choice and posology of anthracyclines for MBC with          Cardiovascular risk at baseline        5. To calculate the cardiovascular risk according to SCORE   "
132126|NCT01555931|"     This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their     infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive     method postpartum. The investigators will compare the frequency of breastfeeding among women     receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after     vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no     difference in breastfeeding prevalence between the two groups.   "
132127|NCT01555918|"     The purpose of this study is to evaluate the pharmacokinetic properties of isavuconazole     (BAL4815) and the cleavage product (BAL8728) and assess the safety and tolerability after     single-dose and steady state (multiple-dose) administration of isavuconazole BAL8557 in     healthy Chinese subjects.   "
132128|NCT01555905|"     The purpose of this study is to determine if inspiratory muscle strength training (IMST) will     impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular     disease.   "
132159|NCT01555125|"     The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI     and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type     psoriasis.   "
132160|NCT01555112|"     The purpose of this study is to determine whether the improved topical ointment formulation,     AS101, is safe and effective in the treatment of external genital warts in females.   "
132161|NCT01555099|"     The purpose of the study is to assess the efficacy and safety of two staggered dose levels of     inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a     background therapy of formoterol.   "
132129|NCT01555892|"     Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or     T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which     has come back, is at risk of coming back, or has not gone away after treatment, including the     best treatment we know for these diseases.      Some patients with Lymphoma or T/NK-lymphoproliferative disease or CAEBV show signs of virus     that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (mono     or the kissing disease) before or at the time of their diagnosis. EBV is found in the     cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role     in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV)     infected by EBV are able to hide from the body's immune system and escape destruction. We     want to see if special white blood cells, called GRALE T cells, that have been trained to     kill EBV infected cells can survive in the blood and affect the tumor.      We have used this sort of therapy to treat a different type of cancer that occurs after bone     marrow or solid organ transplant called post transplant lymphoma. In this type of cancer the     tumor cells have 9 proteins made by EBV on their surface. We grew T cells in the lab that     recognized all 9 proteins and were able to successfully prevent and treat post transplant     lymphoma. However, in HD and NHL, T/NK-lymphoproliferative disease, and CAEBV, the tumor     cells and B cells only express 4 EBV proteins. In a previous study, we made T cells that     recognized all 9 proteins and gave them to patients with HD. Some patients had a partial     response to this therapy but no patients had a complete response. We then did follow up     studies where we made T cells that recognized the 2 EBV proteins seen in patients with     lymphoma, T/NK-lymphoproliferative disease and CAEBV. Those proteins are called LMP-1 and     LMP-2. The cells are called LMP-specific cytotoxic T-Lymphocytes (CTLs). We have treated over     45 people on those studies. About 63% of those patients who had disease at the time they got     the cells had responses including some patients with complete responses. This study will     expand on those results and we will try and make the T cells in the lab in a simpler faster     way. We will also make T cells that will still see the LMP proteins but also 2 other EBV     proteins called EBNA-1 and BARF. These cells are called GRALE T cells. These GRALE CTLs are     an investigational product not approved by the FDA.      The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic GRALE T     cells created using this new manufacturing technique. We will learn what the side effects are     and to see whether this therapy might help patients with HD or NHL or EBV associated     T/NK-lymphoproliferative disease or CAEBV.   "
132130|NCT01555879|"     The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical     practice. The main hypothesis to be examined in this study is, Abatacept's effectiveness     results in a single real-world clinic (n = 100) are reproducible at another site (n ~= 200).   "
132131|NCT01555866|"     This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the     pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in     healthy subjects with normal renal function.   "
132132|NCT01555853|"     This phase I/II trial studies the side effects, maximum tolerated dose, and effectiveness of     paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients     with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. More effective and well     tolerated therapies are needed to treat patients with relapsed and refractory lymphomas.     Nab-paclitaxel combines a chemotherapeutic agent with a protein which may increase the     anticancer drug concentration in the tumor while reducing toxic effects in normal tissue and     may be an effective treatment for lymphoma.   "
132133|NCT01555840|"     A capsule steered by magnetic field force developed by Siemens and Olympus has recently been     evaluated in a pilot series in man with encouraging results (Rey JF, Ogata H, Hosoe N,     Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of     stomach exploration with a guided capsule endoscope. Endoscopy. 2010;42:541-5. Epub 2010 Jun     30.18). This blinded prospective study investigates the accuracy of the magnetically guided     capsule (MGCE) compared to gastroscopy in patients with focal lesions and / or gastric     symptoms and indication for upper GI Endoscopy.   "
132134|NCT01555827|"     A few studies suggest that patients suffering from neurodegenerative diseases (such a     multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve     fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical     coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a     precise and standardized estimation of this parameter, which could constitute a biomarker for     cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD,     prior to damage of the hippocampal region that impacts memory.      Besides, some associations of AD with some degenerative diseases of the eye (glaucoma,     microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.      It therefore seems interesting to determine whether RNFL thickness, and other ocular     parameters, may give some indications for a better detection of AD and cognitive decline in     the elderly.   "
132135|NCT01555814|"     The investigators want to relate disturbances in first-episode schizophrenic patients in     (dopaminergic) D2 receptors, brain structure, brain function, and information processing to     each other and to psychopathology. Additionally, the investigators want to examine the     influence of D2 receptor blockade on these disturbances. The investigators expect     disturbances in the dopaminergic system at baseline to correlate with specific structural and     functional changes and with disruption in information processing as measured with     psychophysiological and neurocognitive methods - and investigators expect D2 receptor     blockade to reverse some of the functional and cognitive impairments. The investigators do     not expect any effect of treatment on brain structure.   "
132136|NCT01555801|"     Preoperative accurately staging T1a or T1b in early esophageal cancer is vital for the     choices of treatment. At present, the main diagnostic method for early esophageal cancer is     endoscopic ultrasound (EUS). However, the accuracy of EUS alone is poor. Thus, it is     necessary to improve endoscopic ultrasound examination methods. This project is concerning on     the efficacy of EUS combining with submucosal injection of saline for staging T1a and     T1b-esophageal cancer. Patients and methods: 80 cases of pathological confirmed early     esophageal cancer were randomly divided into two groups: endoscopic ultrasonography group     (EUS group) and EUS combining with submucosal injecting saline group (EUS+SIS group). All the     cases will be performance by endoscopic or surgical resection; postoperative pathologic     diagnosis will be obtained involving echo, depth, margin and other features. The EUS results     of two groups of patients will be compared with pathologic results. From comparison, the     efficacy and accuracy of EUS+SIS for staging T1a and T1b in esophageal cancer patients will     be validated. Through this study, the investigators may develop a routine diagnostic and     accurately staging method for early esophageal cancer patients.   "
132137|NCT01555788|"     The primary purpose of this pilot study is to test an artificial pancreas system which uses     the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.   "
132162|NCT01555086|"     This study examines Limited versus extended pelvic lymphadenectomy.   "
132314|NCT01553097|"     This longitudinal project will investigate a common complaint of women who receive     chemotherapy for breast cancer- cognitive difficulty. The relationships of fatigue, stress,     and depression to cognitive difficulties will be examined. The findings should lead to     interventions to decrease the effects of these problematic side effects.   "
132138|NCT01555775|"     The aim of this study is to assess the effect of ingesting a commercial carbohydrate and     protein dietary supplement in powder form (P-CHO supplement) or a milk shake with skimmed     milk, strawberries and banana (MS), after resistance exercise, in muscle damage, oxidative     stress, inflammation and functional recovery. It is hypothesised if the ingestion of a milk     shake with skimmed milk and fruit (strawberry and banana) has the same impact on markers of     muscle damage, oxidative stress, inflammation and functional recovery induced by resistance     exercise, as the intake of a commercial powder with the same CHO and protein amounts.      Fifteen adult athletes from the Portuguese Athletic Federation will complete 2 trials     separated at least by 2 weeks. Alternate legs and drinks will be used in each trial and     participants will be overnight-fasted. This study will have a single-blind, randomized,     crossover, repeated-measures experimental design. In each trial, after warm-up, the eccentric     peak torque of the knee joint extensors will be determined using an isokinetic dynamometer.     After this, participants will complete an isokinetic exercise until exhaustion at a constant     angular velocity of 60° • s-1. After the exhaustion protocol, athletes will perform again the     peak torque determination. Immediately after, participants will drink the P-CHO supplement or     MS during the first 2 h. Both drinks will contain 0.8-1.2 g carbohydrates • kg-1 • h-1 and     0.2-0.4 g protein • kg-1 • h-1. Twenty four and 48 h after the exhaustion protocol     participants will return to the laboratory to repeat the peak torque determination. Blood     samples will be collected before warming-up, immediately and 2 h after the last peak torque     determination and 24 h and 48 h after. Serum samples will be analyzed for creatine kinase,     lactate dehydrogenase, interleukine-6, protein carbonyls and total antioxidant status. The     delayed onset muscle soreness, using a visual analogue scale, and girths will be measured at     the same moments as blood sampling. Two-way repeated-measures ANOVA will be used for     statistical analysis of the data.   "
132139|NCT01555762|"     This multicenter, prospective, observational study will evaluate the efficacy and safety of     Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal     cancer. Data will be collected from eligible patients for24 months.   "
132140|NCT01555749|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered     subcutaneously, at two different dose levels, in healthy Japanese subjects.   "
132141|NCT01555736|"     Specific immunotherapy, which involves the administration of allergic extracts to patients     with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology.     According to the latest studies immunotherapy not only reduces symptoms' severity but also     may modify the course of allergic disease by reducing the risk of new sensitisations and     development of more advanced stages of the disease.It has been hypothesized basing on     clinical observation that perennial immunotherapy is more effective and safer in comparison     to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and     preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.   "
132142|NCT01555723|"     Background: Treatment of HIV-1 infected Ugandan children with antiretroviral therapy (ART) is     increasing but few prospective long-term studies evaluating the treatment process have been     reported. In this study we sought to determine prospectively how consistent monitoring of     HIV-1 RNA levels impacts the ART treatment process.      Methods: One hundred and eight children initiating ART were enrolled into this study. These     children had comprehensive laboratory monitoring including HIV-1 RNA level determination and     genotype analysis (where appropriate), CD4 % plus absolute counts, and safety laboratory     measurements performed prior to starting therapy and at regular intervals after receiving     ART. Kaplan-Meier statistics were used to examine predictors of survival and virologic     failure. Viral genotype analysis was performed on samples obtained from children having     virologic failure to determent the emergence of mutations.   "
132143|NCT01555710|"     This is a multinational, multicenter, randomized controlled, open-label, adaptive study to     evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with     extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and     Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio     to receive either PaCE or CE chemotherapy.      The study design uses an adaptive group sequential approach with sample size re-estimation at     the interim analysis.      Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and     disease-related symptoms. Tumor-related endpoints will be assessed according to the Response     Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.      The safety of study treatments will be assessed by the frequency and severity of adverse     events as determined by National Cancer Institute (NCI) Common Terminology Criteria for     Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim     analysis of safety data only will be performed.      An independent Data Monitoring Committee (DMC) will be convened to assess the safety and     efficacy of the study interventions and to monitor the overall conduct of the clinical trial.   "
132144|NCT01555320|"     CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in     treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria, the     study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided into     two groups (treatment and control group) by central randomization service. The treatment     group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag) three     times a day in addition to standardized western medications. Whereas the control group will     be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in     addition to standardized western medications. Efficacy indicators include primary indicator     (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause     death, emergency/re-admission to hospital due to HF, frequency of re-admission due to     cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock,     revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.; Brain     Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function     classification; Minnesota life quality scale; scores from the four traditional chinese     medicine (TCM) diagnostic methods). Other indicators include blood cholesterol, triglyceride,     high density cholesterol and low density cholesterol. Safety indicators include blood     pressure, heart rate, blood and urine routine tests, liver and renal function tests, serum     electrolytes, electrocardiogram and adverse events. All of the patients will receive     interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd, 6th, 9th,     12th month after recruitment. All patients will be followed up until the end of study (Refers     to the 12th month of the last case recruited into the study).   "
132145|NCT01555307|"     The purpose of the study was to evaluate the effectiveness of balance exercises added to     typical joint range of motion and muscle strengthening exercises on balance in patients     following total hip or knee joint arthroplasty   "
132443|NCT01551407|"     The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible     cystoscopy in the detection of histological confirmed bladder tumor lesions defined as     dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.   "
132146|NCT01555294|"     Multiple risk factors contribute to atherosclerosis, which ultimately results in clinical     manifestation of cardiovascular disease. Atherosclerosis results in both functional and     morphological changes in the vessel wall, which can be measured by ultrasonography. The     current study has been designed to        1. To evaluate whether non-invasive measurements of atherosclerosis are independent          predictors of cardiovascular disease and        2. to delineate new biochemical parameters and genetic variations, allowing earlier and          more effective preventive therapy        3. The investigators intend to set guidelines for use of NIMA in an outpatient setting to          facilitate early detection of increased cardiovascular risk and monitor life-style and          pharmaceutical interventions.      In both the general population and in Familial Combined Hyperlipidemia.   "
132147|NCT01555281|"     There is a great need for treatment options in patients with multiple myeloma (MM) after     failure of the lenalidomide/dexamethasone regimen as there is no established standard active     therapy for these patients.      Combining nelfinavir, a drug targeting both the proteasome and PI3K/Akt pathway, with     lenalidomide, may restore lenalidomide-sensitivity to the disease as has been shown in vivo     for the PI3K/Akt inhibitor perifosine and the proteasome inhibitor bortezomib.      Patients expected to be included in the trial are heavily pretreated and might not be     candidates for further intensive therapies. The combination of nelfinavir with     lenalidomide/dexamethasone offers also to these patients an alternative. Preliminary     experiences in another SAKK trial with the combination of bortezomib and nelfinavir are     positive with few side effects with nelfinavir doses of up to 1875 mg twice daily (bid). For     the phase I part of the trial a starting dose of 1250 mg nelfinavir bid was chosen, since the     necessary plasma concentration of nelfinavir will not be reached with lower doses.      In case of progression during or after the trial treatment any other lenalidomide- or     bortezomib-based chemotherapy combination could be an option for the patient. However, the     addition of a chemotherapeutic drug like cyclophosphamide or doxorubicin has known side     effects like hematological toxicities, nausea, vomiting and hair loss.      The aim of this trial is to demonstrate that the combination of nelfinavir with     lenalidomide/dexamethasone is safe (phase I, dose escalation of nelfinavir) and active (phase     II). Patients who do not respond to trial medication will stop trial treatment after 4 months     of therapy at the latest.      If the combination of nelfinavir with lenalidomide/dexamethasone should prove to be safe and     efficient in treatment of lenalidomide-refractory MM, this would be the first orally     available treatment for these patients and establish a new class of drugs (human     immunodeficiency virus (HIV) protease inhibitors) as active antineoplastic agents in MM. In     addition this would establish the concept of re-sensitizing patients to lenalidomide     therapy and demonstrate the effect of nelfinavir on proteasomal degradation and Akt     phosphorylation in cancer patients in vivo.   "
132148|NCT01555268|"     This phase I trial studies the side effects and the best dose of trebananib when given     together with or without low-dose cytarabine in treating patients with acute myeloid leukemia     (AML). Trebananib may stop the growth of AML by blocking blood flow to the cancer. Drugs used     in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Giving trebananib     together with cytarabine may be an effective treatment for patients with AML.   "
132149|NCT01555255|"     This study seeks to determine whether screening pregnant women for malaria with malaria rapid     diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth     outcomes due to malaria in areas of varied malaria transmission in Africa.   "
132150|NCT01555242|"     This is a phase I, open-label, multiple dose, dose escalation study to assess the safety,     tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally     in patients with advanced cancer and lymphomas.   "
132151|NCT01555229|"     Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the     cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic     secretion drainage can be either continuous or intermittent. However, concerns about the     safety of continuous subglottic secretion drainage were raised in an experimental study in     sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is     therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal     mucosa damages in patients requiring mechanical ventilation for an expected duration of more     than 24 hours.   "
132152|NCT01555216|"     Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of     postoperative pain control included oral narcotics, single injection regional techniques and     more recently continuous nerve catheters. Recent studies have demonstrated a benefit with     continuous popliteal catheters when compared to single injection techniques in regards to     postoperative pain control and patient satisfaction for foot surgeries.      Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial     nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and     does not involve the peroneal nerve. The purpose of this study is to compare the continuous     posterior tibial nerve catheter with a single injection posterior tibial nerve block when     used as part of a surgical ankle block for forefoot surgery.   "
132153|NCT01555203|"     The objective of this Phase II research is to evaluate the effectiveness of a     population-based, individually tailored multiple health behavior change program for exercise,     healthy eating, and stress management in a randomized trial including approximately 1,500     college students.   "
132154|NCT01555190|"     Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous     ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our     study is to investigate the role of folic acid conteined in the inositol preparation. The     study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and     subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual     pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test,     euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of     treatment.   "
132155|NCT01555177|"     Background      It is commonly believed that a heart attack is caused by rupture of a plaque in the wall of     the coronary artery, resulting in blood clots which impede blood flow. Currently, the     investigators do not know whether heart attacks in patients who had a recent surgery are     caused by the same disease process as those who did not have any surgery. This study will     inform the investigators of very vital information about the cause of surgery-related heart     attacks by taking images of coronary arteries using Optical Coherence Tomography (OCT).     Images will also be taken from heart attack patients who did not have recent surgery, and the     two groups will be compared.      OCT imaging      OCT is a relatively new imaging technology which is much better at taking images of the     inside of the artery. OCT imaging procedure is carried out at the time of scheduled coronary     angiogram, where a catheter with a mini-camera at its tip is advanced into the coronary     artery, it will record video images of a length of the artery. These images will take     approximately 3-4 seconds to obtain. Besides the OCT imaging being performed, the rest of the     angiogram procedure is carried out in exactly the same way as it would normally proceed.      The OCT study will provide doctors with new information about the cause of surgery-related     heart attacks, and will guide doctors in treating and preventing heart attacks in patients     who undergo surgery.      Hypothesis      The investigators hypothesize that features of acute plaque rupture will be more common in     patients with non-surgery related heart attacks compared to those which occur following     surgery.      Design      Two groups of patients will be recruited(>20 in each group):        1. non-surgery related heart attack patients        2. patients who suffered from a heart attack following an operation.      Outcome measures      Using OCT, plaque features in coronary arteries of patients with heart attacks from both the     surgical and non-surgical groups at the time of coronary angiogram will be compared.   "
132163|NCT01555073|"     Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being     present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has     been hysterectomy in post child bearing woman. However, over the last decade, the use of a     minimal invasive technique called uterine artery embolization has become increasingly popular     due to high patient satisfaction, cost effectiveness, and shorter recovery period. The     purpose of this randomized blinded placebo controlled study is to compare pre-emptive     analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term     pain control, and improved quality of life in woman following uterine artery embolization     surgery. The study consists of four drug groups including a placebo group. The addition of     pregabalin and celecoxib together with epidural analgesia may improve pain management as well     as leading to a better post-procedure outcome in women following uterine artery embolization.      Many investigators believe that the ischemia in the normal myometrium is the primary source     of pain immediately following surgery making postoperative pain management challenging.     Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to     being an effective analgesic for chronic pain syndromes, the use of pregabalin provides     effective postoperative analgesia when it is administered pre-emptively before an operation.     Preemptive analgesia involves the introduction of an analgesic regimen before the onset of     noxious stimuli, with the goal of preventing sensitization of the nervous system to     subsequent stimuli that could amplify pain. In human trials, pregabalin has been demonstrated     to reduce pain, improve sleep, and mood disturbances in patients with post herpetic     neuralgia. The use of celecoxib in combination with pregabalin has shown to provide more     effective analgesia by providing antihyperalgesia. Therefore, the addition of pregabalin and     celecoxib together with epidural analgesia may improve pain management as well as having an     effect on long term sequelae.   "
132164|NCT01555060|"     The purpose of this study is to investigate the effect of daily iron supplements after blood     donation on time to recovery of hemoglobin and iron stores. The study will also determine     whether the effect of iron supplements on time to recovery is different in men and women, in     older vs. younger donors (<60 years old vs. at least 60 years old) and in donors with replete     vs. diminished pre-donation iron stores.   "
132165|NCT01555047|"     Genital ureaplasmas (Ureaplasma urealyticum and Ureaplasma parvum) and genital mycoplasmas     (Mycoplasma hominis and Mycoplasma genitalium) are natural inhabitants of the male urethra     contaminating the semen during ejaculation. However, these microorganisms, especially     Ureaplasma urealyticum (Uu) and Mycoplasma hominis (Mh), are potentially pathogenic species     playing an etiologic role in both genital infections and male infertility. Despite there are     many consentaneous opinions about its relationship with infertility, its correlation with     sperm regular parameters is still controversially. Sperm DNA damage can negatively influence     fertilization rate, embryo cleavage rate, implantation rate, pregnancy and live birth rate,     and is a novel indicator for intrauterine insemination (IUI) pregnancy rate and IVF or ICSI     pregnancy loss rate. Until now, there were fewer clinical researches about the relationship     among Uu and/or Mh infection, sperm DNA damage, and the IUI pregnancy rate. Thus, the     investigators conduct this prospective study to investigate the relationship among them.   "
132166|NCT01555034|"     The Child health and Sports Center, Meir Medical Center, has an intervention program to treat     obese children. The program includes physical activity, nutritional intervention and     behavioral treatment.The emphasis given in the center to physical activity and sport enables     a strong connection with movement therapy. Movement therapy allows obese children to face and     cope with the psychological and emotional aspects of obesity.      The purpose of this study is to evaluate the contribution of the movement therapy     intervention to our program.   "
132167|NCT01555021|"     More than one out of three individuals treated for major depressive disorder (MDD) do not     experience a full reduction of symptoms even when treated with adequate antidepressant     medication. These individuals may have treatment-resistant depression. This is a condition     that contributes to the tremendous costs of MDD, in terms of health care costs, functional     impairment (limitation of an individual's functional ability), and diminished quality of     life.      There is a clear need for personalized medicine, for people at high risk for     treatment-resistant depression. If these individuals could be identified early in the course     of their depression, they could be recommended for more intensive or specialized     interventions. Doing so could improve their likelihood of having a full reduction in their     symptoms.      Today, there are many treatment options for MDD. Individuals can spend months or years in and     out of treatment before receiving one that works for their treatment-resistant depression.      The investigators want to study treatment resistant depression by examining specific genes     (genotyping) that might influence how your body responds to certain antidepressant     medications. This process of examining specific genes is not experimental. To look at your     specific genes, the investigators will collect a saliva sample. Genes contain the material     passed from parent to child that determines the make-up of the body and mind. For example,     some genes control the color of your hair or eyes. Genes are contained in your DNA     (deoxyribonucleic acid). There are many differences in DNA, from one person to another. These     differences may affect a person's chances of having a particular disease.   "
132168|NCT01555008|"     This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),     safety and tolerability of LX4211 following once daily oral administration in subjects with     type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.   "
132169|NCT01554995|"     Primary      - To investigate the safety and tolerability of LCB01-0371 after a single oral dose      Secondary        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral          dose        -  To investigate the safety of LCB01-0371 after a single oral dose   "
132170|NCT01554982|"     A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have     completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may     participate in this trial.   "
132181|NCT01554839|"     The purpose of this study is to evaluate the effectiveness of a unique web based educational     tool called Family of Heroes, which is designed to educate families about Post Traumatic     Stress Disorder (PTSD) and provide them with practical tools for interacting with affected     veteran family members. The study includes veterans and a family member of their choosing.     Participants are randomly assigned to a group which takes the online training or a group that     does not take the training. Both groups complete a baseline questionnaire and a follow up     questionaire 60 days later. The study will examine the number of Veteran Affairs (VA) mental     health visits.   "
132182|NCT01554826|"     The clinical trial was designed to evaluate the immunogenicity and safety against pediatric     Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on     infants age 6 months to 36 months.   "
132183|NCT01554813|"     The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The     purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's     Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old     population.   "
132171|NCT01554969|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine,     radiation, and the study drug kill cancer cells in different ways. Giving these treatments     together may make your cancer shrink or slow down its growth more than it would if you got     treated with capecitabine and radiation alone.      This is a Phase I drug study of ganetespib given together with capecitabine and radiation in     patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not     approved by the Food and Drug Administration (FDA). The other two, capecitabine and     radiation, are approved by FDA for use in rectal cancer.      In this study, the investigators will test different dosages of the investigational     (experimental) drug, called ganetespib (the study drug). The study drug is investigational     because it is not approved by the FDA for use. The study drug has been previously tested in     humans. The study uses a well-established process of slowly increasing drug dosage to     determine the highest dosage that can be given without causing serious side effects. In     addition, the study will help researchers to determine what the side effects and drug     interactions might be.      The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and     capecitabine with radiation work in your body (for example how long the drugs last in your     body.)   "
132172|NCT01554956|"     Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for topical     ocular use will be evaluated for the indication of treatment of ligneous conjunctivitis.      KB046 will be an open-label, historically controlled clinical trial. At least 10 subjects     with ligneous conjunctivitis, for approximately 20 eyes, will be treated and assessed. All     subjects will receive the investigational medicinal product (IMP) for 12 to 48 weeks, with a     possibility for extended treatment (Continuation segment)   "
132173|NCT01554943|"     Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving     node-positive early breast cancer patients with a long median follow-up (~ 15 years)      OBJECTIFS      Primary:      • To compare the incidence of late cardiac events between anthracycline and non-anthracycline     chemotherapy given to node-positive breast cancer patients in the Belgian three arm     randomized clinical trial      Secondary:        -  To compare the late incidence of cardiac events between higher and lower dose          anthracycline treated node-positive breast cancer patients;        -  To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy          for:        -  left ventricular diastolic function assessed by Echo        -  exercise capacity assessed by 6-minute walk test (6MWT)        -  cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI        -  serum cardiac biomarkers (BNP and TNT)        -  patient-reported cardiac symptoms        -  patient-reported cardiac symptoms assessed by QOL questionnaires are associated with          subclinical findings on LVEF assessment        -  cognitive function, functional autonomy, and psychological distress   "
132174|NCT01554930|"     The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a     traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth     disease (HFMD).   "
132175|NCT01554917|"     This study is intended to evaluate the safety and efficacy of Iguratimod in patients with     active Rheumatoid Arthritis.   "
132176|NCT01554904|"     The study will test the hypothesis that training with the Facial-Flex exercise device for six     weeks will improve snoring in patients with primary snoring or very mild sleep apnea.   "
132177|NCT01554891|"     The current study will evaluate the initial reliability and validity of a new instrument, the     INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of Operation     Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans. The     SAFE-TBI is a relatively brief measure developed by INTRuST consortium investigators and     designed to be given by a trained administrator. It allows for a determination of the level     of evidence for exposure to a mild traumatic brain injury (TBI) using the following     categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The first objective is to     determine the reliability (both test-retest and inter-rater) in a sample of 100 veterans     recently returned from deployment at Joint Base Lewis-McChord and Fort Bragg (Cohort 1), who     have screened positive for TBI on the Post-Deployment Health Assessment. The second objective     is to determine the concordance between the SAFE-TBI and the VA TBI Screen in 100 OEF/OIF/OND     veterans within the Northern New England VA Research Consortium (Cohort 2). The third     objective, to be carried out in a sample of 200 Walter Reed National Military Medical Center     (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND patients (Cohort 3), is to determine     the sensitivity and specificity of the SAFE-TBI using the INTRuST study Brain Indices of     Risk for Posttraumatic Stress Disorder after Mild Traumatic Brain Injury initial evaluation     as the gold standard for TBI assessment.   "
132178|NCT01554878|"     The purpose of the study is to evaluate prospectively the outcome of treatment interventions     of knee osteochondral lesions Outerbridge grade III and IV.   "
132179|NCT01554865|"     This study aims to compare the efficacy of a partial meal replacement diet with a     conventional diet, for inducing weight loss and improving metabolic and inflammatory profile,     endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS),     and quality of life in obese men.   "
132180|NCT01554852|"     The purpose of this study is to compare a standard chemotherapy regimen of cyclophosphamide,     dexamethasone plus thalidomide with a newer regimen of cyclophosphamide, dexamethasone plus     lenalidomide with or without carfilzomib.      Patients who do not have the best response to their initial treatment may then also be given     a combination of cyclophosphamide, dexamethasone plus bortezomib.      Patients who are relatively fit may, on their doctor's advice, go on to receive more     intensive chemotherapy, supported with a transplant of their own blood cells. This is     standard treatment which patients may be offered anyway even if they didn't take part in this     study.      After maximal response has been achieved with the treatment described above, and as long as     the myeloma has not got worse, patients will be treated with either long-term lenalidomide,     lenalidomide with vorinostat, or receive no further treatment, with close observation.   "
132184|NCT01554800|"     This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate     the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human     Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease     (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose     will be escalated by cohort.   "
132185|NCT01554787|"     The high levels of fatigue in stroke patients without neurological impairment suggest it has     a central origin rather than being the result of increased physical effort required after     stroke（Winward et al., 2009）. Fatigue is different from post-stroke depression and the more     serious stroke patients are more prone to fatigue（Windward et al., 2009）.      Fatigue is one of the symptoms of qi deficiency,and Astragalus membranaceus is the most     effective of all traditional Chinese medicine and can tonifying middle and tonify the     original qi. Therefore, the aim of this study was to investigate the efficacy of Astragalus     membranaceus on post-stroke fatigue.   "
132186|NCT01554774|"     Many studies have evaluated the viability of measuring the pulmonary vascular resistance     (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary     thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found     other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that in     patients with COPD, the severity of obstruction, expressed by GOLD class, is associated with     an increase of PVR.   "
132187|NCT01554761|"     This study is to evaluate the necessity of considering posterior corneal toricity on     refractive outcome of patients with cataracts and corneal astigmatism after implantation of     intraocular lenses.      This is determined by comparing total corneal and refractive astigmatism,and by comparing the     expected refractive result with actual refractive astigmatism postoperatively,using total     corneal and anterior corneal astigmatism to calculate respectively.   "
132188|NCT01554748|"     The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal     (TMC) joint by monitoring the survival of different implant types using radiostereometry     (RSA) evaluation of the implants.   "
132189|NCT01554735|"     This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced     by exercise and diet, improves metabolic and inflammatory profile, endothelial function,     erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in     obese men.   "
132190|NCT01554722|"     Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal     method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy     and avoidance of needle-nerve contact has not been established. In this study the     investigators tests the hypothesis that the incidence of needle-nerve contact is higher with     the needle insertion in an out-of-plane than with the in-plane approach.   "
132191|NCT01554709|"     The objective of the study is to collect additional information related to the safety and     performance of the CardioGard Cannula during bypass procedures.   "
132192|NCT01554696|"     The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to     severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).   "
132193|NCT01554683|"     The main purpose of this research project is to study how seizure-like activity affects the     blood flow in the brain of patients with Alzheimer's disease (AD). Changes in blood flow can     change memory and thinking ability, as happens in Alzheimer's disease. The investigators are     using a study drug called Levetiracetam, which helps control seizure-like activity to see if     it can help change the abnormal blood flow in the brain that is seen in some people with     Alzheimer's disease.   "
132194|NCT01554670|"     The purpose of this study is to determine whether radio-frequency (RF)-based plasma     micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome     with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that     treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive     either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic     subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40).     Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of     motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of     California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score     were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and     1-year.   "
132195|NCT01554657|"     The goal of the study is to determine if patients who are being treated for pneumonia in the     intensive care unit can be safely treated with five days of antibiotics (the current standard     is seven to eight days). The goal is to determine if the investigators can minimize     antibiotic complications while still treating the infection. Patients in the study are     randomly assigned to either receive antibiotics for a goal of five days or a goal of seven     days. Every patient is followed daily, and if they are not responding to the antibiotics, the     treating team in the intensive care unit care can continue the antibiotics for a longer     course regardless of what group the patient is assigned. The investigator's hypothesis is     that patients in the five day treatment goal will be able to receive less antibiotics than     patients in the seven day treatment goal without any adverse effects.   "
132196|NCT01554644|"     This is a randomized controlled double blinded study involving two (2) investigational sites     in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation     Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This     is a 12-week study.   "
132197|NCT01554631|"     To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg     taken without or with water and the Glucobay standard tablet 100 mg taken with water.   "
132198|NCT01554618|"     The study examines the Safety and efficacy study of exenatide once weekly in children and     adolescents with type 2 diabetes.   "
132199|NCT01554605|"     The objective of this study is to investigate the role of gait disturbance as a cause for     difference in Bone Mineral Density (BMD) between both hips. Each subject will undergo the     following tests: Functional Mobility Testing, Gait analysis, Motion Analysis, Assessments for     Balance and Gait and Cognitive assessments.   "
132211|NCT01554449|"     The purpose of this study is to assess the efficiency of occupational therapy enhanced by     dedicated adaptative video games in rehabilitation of the upper arm of stroke patients in     the acute phase after their cerebro-vascular accident. Our hypothesis is that occupational     therapy enhanced by dedicated adaptative video games is more efficient in improving motor     recovery of the upper arm than conventional occupational therapy alone.   "
134244|NCT01527708|"     Primary objective of this study was to assess the intrasession, intersession and     interobserver variability of the Pentacam-derived curvature and zernike coefficients in back     surface of normal, keratoconic and crosslinked corneas.   "
132200|NCT01554592|"     Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as     a pump to move blood around the body. This sets up a complex physiologic response to     compensate, which include activation of many hormonal mechanisms which result in fluid     accumulation.      In recent years, medications to block the hormonal response to heart failure are given as     standard drugs, and these include ACE inhibitors and beta blockers. Mortality is reduced with     these medications, as well as symptoms improved. Other medications are also used in heart     failure, for which a clear-cut benefit has not been demonstrated. Statins, also called HMG     CoA reductase inhibitors, are used to reduce cholesterol levels and can help to prevent heart     failure by preventing heart attacks. They have been used in heart failure that is not caused     by heart attacks in the belief that they had pleiotropic effects, meaning that they had     beneficial effects in heart failure separate from the reduction in cholesterol.      However large trials in heart failure have demonstrated that statins do not increase survival     compared with placebo. There is no evidence to recommend their routine use in established     heart failure caused by either heart attacks or genetics.      The investigators propose that the use of statins in heart failure is unnecessary and could     be stopped. The importance of finding evidence to cease unproven medications in heart failure     cannot be understated. Patients with heart failure take an average of six prescription     medications each day. Each medication has side effects and the interactions of all the drugs     together are unknown. Statins are the commonest reason for side effects in patients with     heart failure, causing muscle pains and gastrointestinal upset.      In this study, the investigators plan to withdraw statins from patients with stable heart     failure in a closely monitored environment and watch for the effect of this on heart failure     and on how they feel generally.   "
132201|NCT01554579|"     The purpose of this study is to assess the efficacy of a single dose level of gefapixant     (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA)     of the knee compared with placebo after 4 weeks of treatment.      The study will also assess the safety and tolerability, changes in physical function,     stiffness, treatment response and health outcomes.   "
132202|NCT01554566|"     This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in     patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks     intervention periods) was used to measure honey effects. The subjects were randomized into     two groups (intervention to control [I/C] and control to intervention [C/I] groups. Each     group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day     in the first 12-week period (period 1) while the subjects in the C/I group did not receive     honey as a control in period 1. After period 1 the subjects of each group exchanged their     protocol for the following 12-week period (period 2).   "
132203|NCT01554553|"     The purpose of this study is to evaluate the superiority of posterior crural repair during     sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical     reflux disease.   "
132204|NCT01554540|"     The purpose of the study is to assess skin blood flow after non-invasive local administration     of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the     fingers of healthy volunteers and patients with systemic sclerosis. The investigators also     aim at assessing the systemic bioavailability and dermal diffusion of treprostinil     iontophoresis.   "
132205|NCT01554527|"     Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to     problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood.     Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now     performed more often for suspected SDB than for any other indication. However, recent studies     indicate that many if not most children still have SDB after AT, and many still have learning     or behavioral problems associated with SDB. The goals of this study are: (1) to assess the     extent that behavior, cognition, and sleepiness in children can improve with Continuous     positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand     to gain most from post-operative assessment and treatment.   "
132206|NCT01554514|"     Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots     throughout the body that can damage major organs and cause death. TTP is treated with plasma     exchange (also called plasmapheresis). Patients who do not respond initially to plasma     exchange often are helped by later treatment with rituximab. The purpose of this study is to     see whether combining low doses of rituximab with plasma exchange will help patients get     better sooner and reduce the chance of getting TTP again.   "
132207|NCT01554501|"     The purpose of this study is to examine the effects of stress on mental and physical health     and behavior.   "
132208|NCT01554488|"     The Chairman of the Veterans' Disability Benefits Commission reported at a recent US Senate     hearing that asthma, chronic obstructive pulmonary disease (COPD), and sleep apnea are among     the top 13 most frequent diagnoses leading to disability under the Department of Defense and     the VA system statutes. Recent research finds that sleep apnea is more common among asthma     and COPD individuals, and this may be caused by inhaled corticosteroid use. Many Veterans are     currently using inhaled corticosteroids, and many more will be prescribed such medications,     given their recent inclusion in international treatment guidelines. As such, this study     addresses a critical need by researching the role of a potent inhaled corticosteroid in     promoting sleep apnea, the determinants of this response, and the ways through which it     occurs. Results from this study will form the foundation for future research aimed at     expanding understanding of the effects of inhaled corticosteroids on the upper airway, as     well as developing means to prevent or counteract them.   "
132209|NCT01554475|"     So far, no drugs have shown to stop or delay the pathological processes of dementia.     Available pharmacological treatment includes a small number of drugs; cholinesterase     inhibitors like donepezil, galantamine and rivastigmine, and the NMDA receptor antagonist     memantine, all of which only affect the symptoms of the disease. At the same time,     alternative medicines like herbal products and dietary supplements are often intensively     marketed with the assertion of curative or alleviating effects on dementia. The documentation     of clinical effects, side effects and the potential for interaction with prescribed drugs     are, however, generally scarce. The aims of this study are to make a survey of the use of     alternative medicine in patients with dementia and mild cognitive dysfunction attending the     investigators out-patient dementia clinic, and to assess the interaction potential with the     patient's other medications.   "
132210|NCT01554462|"     Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD)     receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary     intervention. Cognitive control functions are measured with functional Magnetic Resonance     Imaging (MRI) before and after the intervention. Behavioural change is monitored with     behavioural scales.   "
132229|NCT01554215|"     Mom Power is a weekly attachment based parenting program aimed to increase parenting and     self-care skills for families.   "
132212|NCT01554436|"     The low overall effectiveness of available smoking cessation treatment so far, indicate the     need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a     highly heterogeneous population. Identification of individual characteristics that predict     success in smoking cessation is highly desirable to allow designing more specific strategies     in order to enhance success in quitting tobacco.The main objective of this study is to assess     whether the presence of certain neuropsychological deficits found before the initiation of     smoking cessation is associated with a greater relapse rate.The secondary objectives concern     how neuropsychological performance are involved in motivation and craving in the whole sample     of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological     factors associated with agood or poor prognosis for success and provived more specific and     therefore more effective care.   "
132213|NCT01554423|"     This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral     Therapy for HIV Prevention in Pretoria, South Africa. The RCT will evaluate the efficacy of a     brief motivational interview (BMI) and a cognitive-behavioral couples' (IFCBT) intervention     alone and in combination against a comparison condition to reduce new cases of HIV and     sexually transmitted infections and increase condom use and decrease sexual risk behavior,     drug use, and intimate partner violence among young female drug users in Pretoria, South     Africa and their primary intimate partners. In the RCT, 384 couples comprised of young female     drug users who do (N = 192) and do not (N = 192) trade sex and their primary intimate     heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and     counseling; (2) brief motivational interview (BMI); (3) cognitive-behavioral couples'     intervention (IFCBT); or (4) BMI and IFCBT combined. Eligibility criteria for couples include     an HIV-negative drug using female aged 18 to 40 and their primary intimate partner or spouse     who is also HIV negative. Each partner of each couple will be administered assessments with a     rapid test for HIV and urine tests for Chlamydia, gonorrhea, trichomoniasis, and drug use at     baseline and 3-month, 6-month, and 12-month follow-up.   "
132214|NCT01554410|"     The primary objective of the study is to identify the highest dose of gemcitabine that can be     given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women     with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce     gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be     feasibly delivered in patients with locally advanced cervical cancer.   "
132215|NCT01554397|"     The purpose of this study is to find out whether patients with cervical cancer treated with     IMRT have less side effects with equal cancer control compared to standard radiation     techniques. With standard radiation techniques, normal pelvic organs near the tumor receive     radiation dose, which leads to side effects. IMRT is a new radiation technique that can     reduce radiation dose to these organs and may reduce side effects.      Compared to conventional RT techniques, the hypothesis is that IMRT will reduce acute     hematologic and gastrointestinal toxicity for cervical cancer patients treated with     concurrent cisplatin.   "
132216|NCT01554384|"     Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can     detect TB genetic material in sputum samples as well as test for genetic resistance to     rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010.     There is limited data on the impact of Xpert on time-to-treatment and TB-related patient     morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the     point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize     that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis,     time-to-treatment and TB related patient morbidity for patients with suspected TB presenting     to primary level TB clinics in high HIV prevalent settings.   "
132217|NCT01554371|"     The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide     (Cytoxan®) given together at different doses. This study will look at what effects, good     and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved     by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has     been approved for different types of cancers (including breast cancer). However, the     combination of eribulin and cyclophosphamide is considered experimental; that means this     combination has not been approved by the FDA.      The funding for this study is provided by Eisai Inc., the maker of eribulin.   "
132218|NCT01554358|"     A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009     have and continues to be randomly assigned to either the intervention group or the control     group. GDM women in the intervention group will have five consulting sessions with a     dietician during the first year and two sessions during the second year. The intervention     group are given detailed advice about how to achieve the six goals of the intervention. The     primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes     (T2D) in women with prior GDM. The second aim will test gene-intervention interactions     through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation     to metabolic traits for T2D in GDM women.   "
132219|NCT01554345|"     The purpose of this study is to determine whether Kidney injury happens in controlled     hypotension during brain operations by using Neutrophil Gelatinase Associated Lipocalin ELISA     Kit and if so, does VitaminE+Selenium prevent it   "
132220|NCT01554332|"     The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an     adjunctive treatment for chronic neuropathic pain.   "
132241|NCT01554059|"     The purpose of the study is to evaluate the efficacy and safety of the combination of     cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy     as neoadjuvant treatment for patients with locally advanced but resectable rectal     adenocarcinoma.   "
132242|NCT01554046|"     The purpose of this study is to investigate the familial response to Methylphenidate     treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects     development.   "
132330|NCT01552889|"     This study compares the effects of depression screening and case management to usual care in     cardiology outpatients with documented evidence of coronary heart disease. Despite strong     evidence that depression is a risk factor for cardiac events, there is insufficient evidence     to support the use of depression screening in cardiac patients.   "
132331|NCT01552876|"     This study is evaluating the initial fit of toric contact lenses.   "
132221|NCT01554319|"     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of     the immune system caused by cytokine production. A substantial number of asthma patients do     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for     novel targeted therapies with improved specificity, tolerability, and compliance.      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting     early disease-causing mechanisms are a promising approach for the treatment of asthma. The     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and     has been shown to be necessary and sufficient for the production of cytokines interleukin     (IL)-4, IL-5, and IL-13. The active principle hgd40 of the investigational medicinal product     SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA     (deoxyribonucleic acid)zymes (antisense oligonucleotide). DNAzymes are catalytically active     nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3     mRNA, hgd40 reduces specific cytokine production and thereby reduces key features of allergic     airway inflammation.      DNAzymes are generated completely by chemical synthesis and can be produced under Good     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,     i.e. they are not generated by use of any living organism including cell culture or bacteria.     The molecules are highly water-soluble and will be applied as solution directly in their     synthesized form.      The current study will evaluate the safety and tolerability of increasing multiple doses of     inhaled SB010 in healthy male subjects.   "
132222|NCT01554306|"     Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor     symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can     also be present during the night. Half of the patients with PD have difficulty turning around     in bed. This nocturnal hypokinesia is considered as a possible cause of sleep problems in     this population. The diagnosis nocturnal hypokinesia is based on the clinical interview.     There is a need for a diagnostic devices that measures nocturnal movements, preferably in the     home setting. This device can be used in the diagnostic trajectory as well in the evaluation     of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has been developed to     register nocturnal movements. The tri-axial accelerometer has been developed to measure     position changes in the night. A validation study with actigraphy and polysomnography     concluded that the Dynaport MiniMod is a valid an feasible device for assessing intensity and     physical activity and changes of body position during sleep.      Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of     dopaminergics is adequate, but most of the time slow release dopaminergics are needed.     However response fluctuations can negatively influence the treatment. In these cases     continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats response     fluctuations during the day and studies show that sleep quality measured with questionnaires     improves. If the improvement of sleep quality is caused by improved bed mobility has not been     studied yet. The study hypothesis is that rotigotine does not influence nocturnal hypokinesia     in PD.      Objective of the study:      Primary:      • To study the effect of rotigotine on nocturnal hypokinesia      Secondary:        -  To study the possibility of measuring nocturnal hypokinesia and its severity in a home          setting        -  To correlate improvements in sleep quality by rotigotine with changes in nocturnal          hypokinesia      Study design:      We will study patients who will recieve rotigotine as a part of their usual care. During     three nights, nocturnal movements are being registered with movement sensors, before     treatment has started as well as after a stable medication dose of one month. We will also     assess sleep quality with questionnaires.      Study population:      The study population are patients with Parkinson's disease with sleep problems caused by     nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited     in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen. We     will ask the treating neurologist to inform us when a patient will start treatment with     rotigotine. One of the researchers will contact the patient to give further information about     the study. The study is a first hypothesis generating study and we will start with the     inclusion of 10 patients.      Intervention (if applicable):      Primary study parameters/outcome of the study:      Position changes over the night.      Secundary study parameters/outcome of the study (if applicable):      Objective        -  Degree of mobility, measured as the speed of the movements        -  Total amount of movements        -  Score on the motor symptom scale according to the MDS-UPDRS part III      Subjective        -  Nocturnal sleep quality Excessive daytime sleepiness        -  Presence of nocturnal akinesia   "
132223|NCT01554293|"     PBL 1427 is a Dipeptidyl peptidase (DPP)-IV inhibitor being developed for treatment of type 2     diabetes. Although a number of DPP-IV inhibitors have been described, there still exists a     need for new DPP-IV inhibitors that have better half-life, advantageous potency, stability     and selectivity, less toxicity and/or better pharmacodynamic properties.   "
132224|NCT01554280|"     The purpose of this study is to investigate whether preventative placement of a removable     oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the     precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The     stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks     later by repeat Endoscopy. Patients will be followed up weekly following insertion of the     oesophageal stent.   "
132225|NCT01554267|"     In the investigators previous study of 51 breast reconstructions (32 patients), we compared     three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein     dye angiography (FDA) and laser-assisted indocyanine green dye angiography (ICG). Because     tissue with poor perfusion becomes necrotic and can compromise the success of breast     reconstruction, it is important that tissue with poor perfusion be removed at the time of the     reconstructive surgery. However, it is also important to remove the least amount of     potentially necrotic tissue as possible so that the breast reconstruction is not compromised     by lack of skin. Therefore finding the best way to assess potentially necrotic tissue is a     vital clinical question. In the initial study the 3 different assessment methods which were     made at the time of surgery were compared to the subsequent development of necrotic tissue.      In the initial study, clinical judgment was the basis for determining the tissue removed     because it had the potential to become necrotic. The investigators collected data with the     FDA system and ICG system, but this data was not used in making the clinical decisions. The     study followed the progression of tissue to overt necrosis and this clinical outcome was then     compared to the predictions made by the three different assessment strategies. The     investigators found that clinical judgment failed to detect tissue which subsequently became     necrotic in 21 out of 51 instances for a failure rate of 41%. The FDA system predicted larger     areas of potentially necrotic tissue than clinical judgment, but was found to over-predict     the area that became necrotic by 82% - 88% (88% if all cases were included and 82% if only     those cases which subsequently developed necrosis were included). Although the ICG system is     similar to the FDA system in that a dye is used to assess perfusion, the ICG system has     enhanced software which improves the estimated perfusion. The ICG system provided 90%     sensitivity and 100% specificity in the predicted vs. actual necrotic tissue at specific     absolute perfusion units values.      Hypothesis: Using the values of absolute perfusion units discovered in the previous study and     implementing its use in the operating room will decrease all-inclusive necrosis rates to     below 10%, reflecting a 31% decrease in the investigators necrosis rate.   "
132226|NCT01554254|"     Engraftment failure is a major obstacle to the success of cord blood transplantation in     children with malignancies and inherited metabolic disorders, despite the fact that they     receive relatively high doses of nucleated cells from UCB. TXA127 is pharmaceutically     formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (which     contains the 8th amino acid conferring receptor binding to blood pressure receptors). TXA127     has multilineage effects on hematopoietic progenitors in vitro and in vivo. Preclinical data     show that TXA127 is a novel stimulator of early multilineage hematopoietic progenitors,     increases engraftment of committed hematopoietic progenitors, and induces more rapid     production of platelets and neutrophils in the peripheral circulation, especially in limited     cell number transplants. Treatment with TXA127 following UCBT is expected to increase the     numbers of hematopoietic progenitors and accelerate engraftment.   "
132227|NCT01554241|"     Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D     supplementation. The limited data available show marked inter-individual variability in     response to vitamin D supplementation in very old, frail elderly with almost 25% remaining     vitamin D deficient (25-OH D < 20 ng/mL) when receiving the currently recommended 800 IU/day     vitamin D. This proposal is for exploratory research on the use of a wide range of oral     vitamin D3 doses in frail elderly living in controlled living environments.   "
132228|NCT01554228|"     Bariatric surgery provides a strong and long-term effect in reducing weight in obese     subjects. Studies showed that obesity and its comorbidities are associated with a lower     cognitive performance. The aim of the researchers study is to examine the cognitive     performance of the patients before and after bariatric surgery.   "
132230|NCT01554202|"     According to estimations, Alzheimer's disease affects approximately 860,000 people aged of     more than 65 years in France. This disease is characterized by disorders of cognitive     functions, including memory, associated with structural and functional modifications of the     brain. These changes are evolving within the pathology progression and can be evaluated with     neuropsychological tests (to assess capabilities such as language, orientation, etc.) and     also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood,     nevertheless currently available treatments can slow its development if the disease is     diagnosed early enough.      Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to     better describe the evolution of this disease.      The three main objectives of this project are        -  to identify, compare and combine predictive markers of Alzheimer's disease        -  to make a significant contribution to the understanding of the pathophysiological          mechanisms of Alzheimer's disease        -  to study the ability of different neuroimaging techniques to follow the evolution of          this pathology.   "
132231|NCT01554189|"     This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics     (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts     to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll     only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a     HCV-infected participants. All parts may run concurrently, or may be staggered as needed by     the clinical sites.   "
132232|NCT01554176|"     The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096)     versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants     who are partial responders to antidepressant monotherapy with one of identified selective     serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors     (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to     placebo as augmentation therapy with respect to change from baseline to Week 6 in the     Montgomery Asberg Depression Rating Scale (MADRS) total score.   "
132233|NCT01554163|"     The main purpose of this study is to establish that etoricoxib 30 mg is safe and not inferior     to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in Korean     patients. Given that the efficacy of etoricoxib vs. placebo in the treatment of     osteoarthritis has been established, and that prescription drugs, such as celecoxib, are     available for the treatment of pain associated with osteoarthritis in Korea, it would be     inappropriate to subject patients with a flare of osteoarthritic pain to the placebo     treatment for 12 weeks, and thus the study is designed as an active-comparator study.   "
132234|NCT01554150|"     The purpose of this study is to determine whether Method of Levels Cognitive Therapy is an     effective intervention for treating clients with a range of presenting problems in primary     care by comparing it with a waiting list control condition.   "
132235|NCT01554137|"     Stroke (CVA) is the leading cause of death and the leading cause of disability in developed     countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients keep     a permanent disability in 75% of cases and only one quarter of them is able to resume work.     The post stroke sequelae are sensory-motor and cognitive.      According to literature data, 75-83% of patients who survive a stroke learn to walk only 25     to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).      The existence of a phase called plateau in motor recovery after stroke has been suggested     (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase     where the rehabilitation techniques used in the subacute phase are deemed less effective.     Recently, Page (2004) speculated that this plateau phase is rather the consequence of     adaptation to the type of patient follow-up training and not that of a limit to the     possibilities of recovery. In an observational study on the recovery of upper limb conducted     over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post     stroke. The results of studies on different techniques for rehabilitation of chronic stroke     patients tend to confirm the hypothesis of page. Therefore, varying the training parameters     (type, intensity, frequency) could improve the functional capabilities of these patients,     even at a distance of stroke.      Strength training is part of the management of hemiparetic patients. The results of several     studies show an improvement in muscle strength and functional ability to walk after a     building program isokinetic lower limb (Sharp, 1997).      The objective of our project is to evaluate the effectiveness of a building program of     isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months of     a stroke.   "
132236|NCT01554124|"     This phase I-II multicenter international trial is designed to study the pharmacokinetics of     meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤     90 days of postnatal age with probable or confirmed bacterial meningitis.   "
132237|NCT01554111|"     Objective and Hypothesis:      The investigators objective is to help determine the efficacy of oral and rectal bowel     preparation regimens for sigmoidoscopy. The investigators hypothesis is that oral preparation     will reduce the amount of repeat rectal enemas required and improve the quality of a bowel     exam at the sigmoidoscopy.   "
132238|NCT01554098|"     This study will compare two strategies for colonoscope withdrawal, using polyp detection as     the primary outcome measure, to determine the optimal withdrawal strategy.      Null Hypothesis:      On withdrawal of the colonoscope, examining patients with dynamic position change does not     yield more polyps than the supine position.      Alternative Hypothesis:      On withdrawal of the colonoscope, examining the patients with dynamic position change     improves polyp detection compared to the supine position.   "
132239|NCT01554085|"     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,     tolerability, and pharmacokinetics of orally administered ALS-002158 in healthy volunteers     (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.      Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will     assess food effects on pharmacokinetics in HV.      Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC     genotype 1 infection.   "
132240|NCT01554072|"     Pulmonary rehabilitation consists of a multidisciplinary program of care for patients with     chronic respiratory disease, which currently encompasses numerous features and physical     training methods aimed at maintaining stability clinic for people with Chronic Obstructive     Pulmonary Disease (COPD), especially in patients who, even with optimized clinical treatment,     continue their decline and symptomatic physical functions and 8 so that these social. goals     are achieved the patient with COPD should integrate into a program of RP assiduous and with     accompanying several times per week, for several months, which for a number of factors is not     always possible. For this reason, it is the research of methodology of RP that hold their     effectiveness, but with greater flexibility and viability to people with COPD. On this basis,     this study aims to investigate the effectiveness of a program of RP semi-domiciliar in which     the patient suffering from COPD can receive guidance and training in person, to develop it     partially in own domicile.   "
132243|NCT01554033|"     REGISTRY is a multi-centre, multi-national, prospective, observational study of Huntington's     disease (HD) with a control group of volunteers. It is an open-ended study which will include     as many eligible participants as willing to participate. The goal of the project is to     collect longitudinal data on the phenotypical characteristics of HD gene mutation carriers     regardless of whether they display clinical symptoms and signs of the disease and of     individuals who are part of an HD family (irrespective of their mutation carrier status), in     order to:        -  obtain natural history data on a wide spectrum of HD mutation carriers and individuals          who are part of an HD family        -  relate phenotypical characteristics             -  with genetic factors ('genetic modifiers')             -  with data derived from the study of body fluids (blood, urine - 'wet biomarker')               and             -  imaging data ('dry biomarker')        -  expedite identification and recruitment of participants for clinical trials        -  develop and validate sensitive and reliable outcome measures for detecting onset and          change over the natural course of premanifest and manifest HD which may also be          potential outcome measures for use in future clinical trials and clinical care.        -  plan for future research studies (observational and interventional trials aimed at          better symptom control or aimed at slowing or postponing the onset and progression of          HD).   "
132244|NCT01554020|"     This prospective international clinical trial is a two-arm, double-blind, randomized,     placebo-controlled, parallel-group, multicenter study. 112 prediabetic subjects will be     randomized to Blood Sugar Take Care or placebo. Randomization will be stratified by gender.     The intervention period is 12 weeks. The primary outcome is fasting glucose levels.   "
132245|NCT01554007|"     In the past decade, the incidence and prevalence of CD (Crohn's disease) has continued to     increase in Korea. Previous studies have indicated that Asian IBD (inflammatory bowel     disease) patients differ from those of Western patients with regard to the genetic     susceptibility and some clinical features. However, the available published data from     retrospective studies in Korea were largely incomplete. The investigators aim of the study is     a set-up of Korean cohort for CD, and thereby to assess the clinical course of Korean CD     patients through a prospective multicenter long-term follow-up study. Secondary aims of this     study are as follows: (1) to evaluate the efficacy, tolerability, and predictors to response     to anti-TNF therapy for CD, (2) to identify the risk factors for postoperative recurrence on     the basis of information obtained at initial diagnosis, and (3) to evaluate     genotype-phenotype correlation.   "
132246|NCT01553994|"     Overview and rationale: Through Swedish health care registers it is possible vaccine     effectiveness. The overall aim is to develop tools for fast and reliable evaluation of     vaccines focusing on effectiveness. In this study the investigators will assess the     population impact on condyloma prescribed drugs after HPV-vaccination and to estimate the     economic burden of hospitalizations due to condyloma. Genital warts (condyloma) are one of     the most common sexually transmitted diseases in Sweden, estimated 20 000 identified cases     per year, and are primarily treated with Podofyllotoxin and Immiquimod. One of the approved     HPV vaccines also protects against condyloma. In clinical trials, this vaccine is safe and     highly efficacious (90-100%) against persistent infection with HPV 6 and 11 and genital warts     in women and men. However, these results are from clinical trials and do not answer the     question weather the vaccine works when delivered, as it would be in the real world. By     linkage between the Svevac, the patient register and the Drug prescription register the     investigators can estimate the effectiveness of the HPV vaccine in preventing cases of     condyloma in a defined population.      Method and execution: This is a retrospective collection of data from Swedish health care     registries where the study population will consist of persons who are HPV-vaccinated as well     as a non-HPV-vaccinated control group (identified through the population-based register,     matched on sex, age and living area). The primary statistical analysis will be a calculation     of prescriptions of condyloma treatments after vaccination compared to the non-vaccinated     control group.   "
132247|NCT01553981|"     Systemic sclerosis (SSc, scleroderma) is a multisystem autoimmune rheumatic disease that     causes inﬂammation, vascular damage and ﬁbrosis. Besides involvement of skin, fibrosis also     affects lung and heart. Although advances in understanding in pathophysiology and use of     immunosuppressive therapy has brought significant improvement in outcome of other autoimmune     diseases, scleroderma still remains as a disease with high mortality and 10 yr survival rate     has improved only from 54% to 66% during last 25 years1. The frequency of deaths due to renal     crisis significantly decreased (mainly due to effectiveness of ACE Inhibitors), from 42% to     6% of scleroderma-related deaths (p 0.001), whereas the proportion of patients with     scleroderma who died of pulmonary fibrosis increased (due to lack of significant treatment)     from 6% to 33% (p 0.001). However, presently, trials with immunosuppressive drugs including     cyclophosphamide and other targeted molecules like Bosentan and Imatinib mesylate have shown     very modest results at the best and given the risk of toxicity. The investigators have     conducted three clinical trials with PDE5 inhibitor Tadalafil in the refractory Raynaud's     phenomenon (RP) in SSc over last 3 years and had found good response in RP, healing of     digital ulcers, prevention of new digital ulcers and also observed improvement in skin     tightening, endothelial dysfunction and improvement of quality of life. The investigators     therefore hypothesize that tadalafil may have an efficacy in improving the ILD of SSc.      The investigators therefore design this double-blind, randomized, placebo-controlled trial of     oral Tadalafil (20 mg alternate day) in patients with SSc having ILD. Patients will be     randomly assigned in a 1:1 ratio to receive either Tadalafil or matched placebo and will be     followed up for 6 months. Prednisolone (if required for indications other than ILD) will be     allowed up to 10 mg/d in all patients. Patient/s requiring more than 10 mg/d of prednisolone     or equivalent dose of steroid will be excluded from the study. Patients who will fail on     therapy during the study will be excluded from the study and will be asked to choose any     therapeutic option from the rescue protocol.      Patients with FVC ≤ 70% predicted or DLCO ≤ 70 % of predicted, Evidence of ILD on HRCT will     be enrolled. The primary objective of the study will be the change in FVC (expressed as a     percentage of the predicted value) from baseline values at the end of 6-months of treatment.     The secondary objectives will be improvement in dyspnea, improvement in 6 min walk distance,     change in DLCO, change in total lung capacity, change in the disability index of the Health     Assessment Questionnaire (S HAQ), and change quality of life (SF-36), levels of NT pro-BNP     and fibrosis markers.   "
132256|NCT01553851|"     This phase II trial studies how trametinib effects tumor cells in patients with oral cavity     squamous cell carcinoma that can be removed by surgery. Trametinib may shrink the tumor by     blocking an enzyme pathway needed for cell growth.   "
132257|NCT01553838|"     The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher     prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy     in patients with increased PSA values > 4.0 ng/ml.   "
132332|NCT01552863|"     This is an open-label (both the physician and healthy volunteer know which medication will be     administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of     oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated     by the body). This study will consist of three parts that will take place over approximately     90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period     each.   "
132248|NCT01553968|"     It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie     insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus.     Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected     that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will     accumulate, because of an improved balance between supply and demand of lipids.      The major research objective is to examine if acute exercise results in a more pronounced     increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained     subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in     endurance-trained subjects when compared to sedentary subjects.      The investigators hypothesize that the increase in acetylcarnitine levels will be lower in     trained subjects when compared to sedentary subjects, due to a better balance between lipid     supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine     concentrations will be restored faster in these trained subjects, because of a tighter     regulation of influx of fatty acids.      To test this hypothesis the investigators want to compare the acetylcarnitine response to     exercise in a group of sedentary subjects and a group of endurance trained subjects. This     response will be measured for 30 minutes after exercise with the use of 1H-MRS.   "
132249|NCT01553955|"     This is a device study in some respects, in that specialized centrifuges are commonly used to     make platelet rich plasma, and we are studying the use of standard laboratory equipment to do     so. However, it is primarily interventional in that we will evaluate the percentage success     of trainees in the concentration of viable platelets to more than 4X baseline using a generic     speed centrifuge and a single spin method.   "
132250|NCT01553942|"     This research study is a Phase II clinical trial. Phase II clinical trials test the     effectiveness of an investigational drug to learn whether the drug works in treating a     specific cancer. Investigational means that the drug is still being studied and that study     doctors are trying to find out more about it-such as the safest dose to use, the side effects     it may cause, and if the drug is effective for treating different types of cancer. It also     means that the FDA has not yet approved the drug for the patients type of cancer or for any     use outside of research studies.      Chemotherapy and radiation is the standard treatment for the patients with stage III     non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR)     mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase     the response to treatment.      Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in     participants with more advanced NSCLC. Results from that study indicate it may be helpful in     treating NSCLC with EGFR mutations.      In this study, patients with stage III NSCLC and EGFR mutations will receive the standard     treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by     surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim     of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the     radiation therapy more effective since radiation therapy tends to work better on smaller     tumors.      The goal of this study is to see if adding afatinib to standard treatment helps to improve     the response to treatment.   "
132251|NCT01553929|"     Regular physical activity is now recognized as a key element of good physical and mental     health and this all ages.      MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive     training in improving the cognitive function of patients diagnosed with Mild Cognitive     Impairment (MCI).      DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for     the patient with three groups : one physical training and cognitive exercise group, one     physical training without cognitive exercise group and one control group.      In agreement with the literature on the effects of physiological stress on cognitive     performance, the investigators expect the best cognitive test scores in groups with exercise     training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD,     depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire.     Furthermore the investigators hypothesize that this positive effect is greater in the     physical training and cognitive exercise group compared with the physical training group     only.   "
132252|NCT01553916|"     This phase I/II trial studies the effects and safety of giving lithium carbonate (lithium) to     patients with small cell lung cancer (SCLC) undergoing radiation therapy to the brain (PCI;     prophylactic cranial irradiation). PCI is used to prevent cancer metastases from returning in     the brain. This treatment can cause short-term memory problems by damaging the hippocampus.     Lithium may help prevent or lessen memory problems caused by PCI by protecting the     hippocampus.   "
132253|NCT01553903|"     This is a biomedical study of interventional type which includes 29 patients on 9 months: 8     months recruiting and 1 month follow up.      Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an     indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will     be enrolled in this study.      The main objective of this study is to evaluate the feasibility for the determination of     Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of     treatment (ie, at D0 before and D28 after beginning of treatment).   "
132254|NCT01553890|"     The aim is to find the presence of anti vitamin D antibodies in scleroderma patients and     compare with control. A second goal is anti vitamin D levels in serum of scleroderma patients     in relation to the clinical manifestations of the disease.   "
132255|NCT01553877|"     The prevention of malnutrition among children under 5 years of age requires consumption of     nutritious food, including exclusive breast feeding for the first six months of life,     followed by breastfeeding in combination with complementary foods thereafter until at least     24 months of age; a hygienic environment; access to preventive as well as curative health     services, and good prenatal care. The proposed research is on the possible options for     providing a nutritious diet, realizing the constraints of poverty and food insecurity faced     by care givers whose children are at risk of developing or confirmed to be suffering from     moderate malnutrition. Even when people are not typically food insecure but consume a     relatively monotonous diet with few good-quality foods, they also have to have options for     dietary improvement, and especially the possibility of ready-to-use complementary food     supplements (RUCFS) for young children. This proposed research on development of RUCFS will     pave the way for programmatic considerations for expansion of the use of new complementary     food supplements for preventing malnutrition among young children in Bangladesh.   "
132258|NCT01553825|"     Assessing the mindset of cancer patients will help us better understand which patients are     having difficulty dealing with the diagnosis and treatment that may not otherwise be fully     appreciated by their physicians. By identifying such patients, we may then be able to design     and implement strategies that can help improve their coping skills both during the treatment     as well as after the completion of treatment. In addition to addressing physical concerns and     symptoms, this approach will help address the overall emotional impact of a cancer diagnosis     as more patients are living as cancer survivors.   "
132259|NCT01553812|"     The study hypothesize that parameters of new function machine---'forced oscillation     technique' (FOT) can correlate well with the conventional lung function data for measurement     of airway resistance and airtrapping in elderly COPD patients.   "
132260|NCT01553799|"     tracheal and endobronchial misplaced will be checked quickly qith US   "
132261|NCT01553786|"     This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by     complete response rate at the end of treatment. Approximately 80 patients aged between 60 and     80 years will be included, to have 70 evaluable patients. The treatment consists of two     phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment     duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be     administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is     taken for 14 days. Patients will be followed for at least 18 months after inclusion of the     last patient.   "
132262|NCT01553773|"     The aim of this trial was to compare the effects of estradiol or genistein treatment on the     hialuronic acid concentration on the postmenopausal facial skin. In this study, 30     postmenopausal women were evaluated through a prospective, randomized, double-blind trial.     The volunteers were postmenopausal women treated in the Gynecology Department of the Federal     University of São Paulo (UNIFESP). The participants were divided into two groups: group E,     treated with 17 β estradiol gel 0.01% (n = 15), and group G, treated with genistein gel 4 %     (isoflavones, n=15). The length of treatment was 24 consecutive weeks. Preauricular skin     biopsies were performed on each patient before and after the treatment for evaluating     hyaluronic acid in the tissue. The materials were processed through immunohistochemical and     biochemical methods.   "
132263|NCT01553760|"     The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as     the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm     corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal     incision).   "
132264|NCT01553747|"     The purpose of this study is to determine the efficacy, safety, and tolerability of different     doses of JNJ-27018966 compared with placebo in the treatment of patients with     diarrhea-predominant irritable bowel syndrome.   "
132265|NCT01553734|"     The macrolide group of antibiotics can cause QT prolongation, and endanger the patient with     life threatening arrythmias. QT prolongation caused by Azythromycin, a relatively new     macrolide, is extremely rare, and was not reported in clinical trials. Our hypothesis is that     patients hospitalized with severe community acquired pneumonia, usually with multiple     comorbid conditions will have a higher rate of QT prolongation, compared to the clinical     trials published   "
132266|NCT01553721|"     This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy     and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).   "
132267|NCT01553708|"     Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of     epithelialization. However, it depends on the depth of the wounds and patient condition.     Infection is one of the most common complications causing delay in wound healing which might     affect to quality of patient's life. Generally, the standard treatment of partial thickness     burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the     broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate     the accelerating effect of wound healing. Therefore, the combination of substance which can     promote wound healing to topical silver sulfadiazine cream might benefit for partial     thickness burn wound treatment.      The objective of this study was to compare the results of partial thickness burn wound     treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine     plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data     (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type     of pain and itching medication, adverse effect of topical medication, some laboratory results     and cost of expenses.      This is the prospective, double blinded, randomize-controlled study. The sample sizes were     partial thickness burn wound patients who were treated at burn unit, Siriraj hospital.     Patients were allocated into 2 groups receiving treatment with either topical silver     sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with     repeated measure ANOVA and independent t-test.   "
132268|NCT01553695|"     ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5%     of adults worldwide. This condition is under-recognised in France and other European     countries and, therefore, under-diagnosed.      As part of the European Network for Adult ADHD, the investigators translated into French a     structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators     also translated rating scales such as the ASRS and the WURS. Validation studies are rare in     France.      The aim of this study is to include two groups of 50 adults whether they have or not ADHD     with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as     implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to     fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale     (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a     screening tool for ADHD in childhood with respect of the Utah criteria). The investigator     will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the     past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence     of ADHD in adults will be computed.   "
132279|NCT01553552|"     SchistoVAN aims to study the role of schistosomiasis infection in the modulation of the     immune response of children to childhood vaccine antigens, as well as the impact of this     infection on their nutritional status and their haemoglobinaemia.   "
132333|NCT01552850|"     To estimate the pharmacokinetics and relative bioavailability of oxycodone after     administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution   "
132269|NCT01553682|"     Young African-American women who report a higher frequency of alcohol use have particularly     higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV)     sex behaviors. Unfortunately, there are no evidence-based HIV interventions designed to be     gender- and culturally-appropriate for this population. To address this, the investigators     propose to add to the CDC-defined evidence-based intervention (DEBI), Horizons, a new     intervention form, Group Motivational Enhancement Therapy (GMET), which has shown promise in     reducing alcohol use and alcohol-related HIV risk-taking. To test how effective the combined     Horizons+GMET alcohol-specific portion is, it will be evaluated with a time equivalent     Horizons+attention control general health promotion (GHP) portion focusing on nutrition     health promotion, and to an enhanced standard-of-care program. In this study, 600 young     African American women, 18-24 years of age, who report 3 or more occasions where they drank     alcohol in the past 90 days will be recruited to complete a four-part baseline assessment     consisting of: 1. an audio computer assisted self interview (ACASI), 2. videotaped     communication role plays to objectively measure communication skill ability (subsample), 3.     provide a vaginal specimen to test for STDs and 4. Provide a urine pregnancy screen. After     participants complete their baseline assessment, they will be randomly assigned to one of     three conditions: 1. Horizons+GMET alcohol-specific condition, 2. a time-equivalent     Horizons+GHP condition, or 3. an enhanced standard-of-care control condition. The GMET     alcohol-specific component has shown to be effective in influencing several alcohol-specific     concepts (attitudes, norms, self-efficacy) and reducing sexual risk-taking among     culturally-diverse high-risk youth. The GMET alcohol-specific module was designed to increase     woman's awareness of the unfavorable effects of alcohol on themselves, their sexual     decision-making, and their male partner and teaches women strategies to reduce the     possibility of engaging in sex under the influence of alcohol. In addition, the GMET     alcohol-specific module provides skills training needed to effectively talk about sexual     intentions to use condoms and/or refuse risky sex when they or their male sex partner has     been using alcohol. After completing one of the three conditions, participants will complete     a brief ACASI posttest to evaluate immediate changes in hypothesized social and psychological     mediators of safer sex and alcohol use. Participants will also return to complete follow-up     assessments at 3, 6, 9, and 12-months after their intervention. If the Horizons+GMET     intervention is observed to be effective, investigators will work closely with the CDC DEBI     program to help distribute the intervention to public health agencies and community based     organizations (CBOs).   "
132270|NCT01553669|"     The primary hypothesis is, comparing with the control group, reminiscence therapy is     significantly and clinically effective to improve the experiment group's depressive symptoms     after six weeks therapy, and the efficacy can be maintained on the three months follow-up.      The secondary hypothesis is, comparing with the control group, reminiscence therapy     significantly reduce the loneliness and increase the self-esteem and life satisfaction of the     experiment group.   "
132271|NCT01553656|"     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics     (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral     doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors.     Also, the effect of XL184 in the treatment of non-small cell lung cancer (NSCLC) patients     with various activating mutations will be evaluated at the recommended Phase 2 dose.   "
132272|NCT01553643|"     Intracranial arterial prominent stenosis (IAPS) is one of main cause of stroke especially in     Asia. Although antiplatelet aggregative or anticoagulant agent and even surgical operation     are used to treat patients with IAPS, the incidence of stroke occurrence still remains high.     In addition, symptomatic IAPS most common cause continuous deterioration, thus, increase the     incidence of stroke. Therefore, there is a good method to reduce the inceidence of stroke     that is to prevent the progressive deterioration of IAPS.      Huang-Chi-Wu-Wu-Tang is made of Astrgalus membranaceus (Fisch.) Gge , Paeonia lactiflora Pall     , Cinnamom Twig , Zingiber officinale Rose , Ziziphus jujube Mill , and can treat hemiplegia     in the traditional Chinese medicine writings. Astragaloside IV is a component of Astrgalus     membranaceus, may reduce th cerebral infarction area in middle cerebral arterial occlusion     mice. The investigators previous studies have known that paeoniflorin that a component of     Paeonia lactiflora Pall can decrease the cerebral infarction area and neurological deficit in     middle cerebral arterial occlusion rats. Therefore, the purpose of the present study was to     investigate the effect of Huang-Chi-Wu-Wu-Tang on patients with IAPS.   "
132273|NCT01553630|"     Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and     distal tibia are difficult to treat and typically have more complications than other     metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures     are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia     treated with locked plates often have a critical sized fracture gap (poorly organized     cortical pieces many of which are stripped of soft tissue). Optimal management strategies     that minimize both fracture healing time and complication rates remain controversial. Primary     bone grafts or early secondary bone grafts have been recommended for these comminuted open     fractures, but have not been studied as the primary end point in a randomized trial. There is     a need to study primary bone grafting during open reduction and internal fixation (plating)     of these difficult fractures, to determine if shorter healing time, and thus less need for     reoperation, can be achieved.      Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and     radiographic union with a lower need for secondary procedures   "
132274|NCT01553617|"     The study will compare the efficacy and safety of VolulyteTM and human albumin in elective     open-heart surgery in adult patients.   "
132275|NCT01553604|"     This study was designed to determine whether the duration of dressing wear following     augmentation mammaplasty influence skin colonization and eventually surgical site infections     rates.   "
132276|NCT01553591|"     The purpose of this study is to determine the efficacy, safety, and tolerability of different     doses of JNJ-27018966 compared with placebo in the treatment of patients with     diarrhea-predominant irritable bowel syndrome.   "
132277|NCT01553578|"     This randomized clinical trial studies healing touch or guided imagery in treating pain,     fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided     imagery may help treat complications caused by chemotherapy. It is not yet known whether     healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and     anxiety in patients undergoing chemotherapy   "
132278|NCT01553565|"     1. Background: The ideal method to remove small colorectal polyps in patients who are          taking antithrombotic agents is unknown.        2. Aim: The aim of this study is to evaluate postpolypectomy bleeding and the complete          retrieval rate after the removal by colon snare transection without electrocautery for          small polyps in patients who are taking antithrombotic agents.        3. Design: A prospective, consecutive study.        4. Setting: Municipal hospital outpatients.        5. Interventions: Polypectomy by cold snare technique (Cold polypectomy) was performed for          colorectal polyps up to 10 mm in diameter in patients who continue to take          antithrombotic agents. The primary outcome measure was bleeding within two weeks after          polypectomy. Secondary outcome measure was the complete retrieval rate of colorectal          polyps based on the pathological examination.   "
132282|NCT01553513|"     This is a single-centre prospective trial with 140 patients employing     [18F]-fluorodeoxyglucose positron emission computed tomography (FDG PET/CT) and advance     motion correction and image fusion algorithms to create motion frozen displays and quantify     FDG-uptake and thus inflammatory activity in atherosclerotic plaques in the coronary tree.     Four groups of patients, two with stable coronary artery disease and two with acute coronary     syndrome will be compared and the results of FDG PET/CT will be correlated to results of     invasive coronary angiography, intravascular ultrasound / virtual histology, patient risk     profile and serum markers of inflammation.      The investigators hypothesize that increased FDG accumulation in atherosclerotic plaques     shows a positive correlation with inflammatory activity in coronary plaques and markers of     plaque vulnerability as well as the risk profile of the patients and serum markers of     inflammation. The investigators furthermore hypothesize that FDG PET/CT is able to detect     high risk patients and provide an important means for risk stratification and optimization of     patient management.   "
132283|NCT01553500|"     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly     becoming the one of most common causes of chronic liver disease in children. The pathogenesis     of NAFLD is generally considered the result of a series of liver injuries, commonly referred     as multi-hit hypothesis. Insulin resistance and increased serum levels of free fatty acids     (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in     hepatocytes resulting in steatosis.      Has been reported that a diet rich in high-viscosity fiber improves glycemic control and     lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.      Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children     affected by non alcoholic fatty liver disease.   "
132284|NCT01553487|"     The aim of the present study is to investigate the effects of vibrating the forearm bone in     the free limb on muscle strength and bone mineral density of the forearm in patients with     forearm/elbow fracture.      A total of 80 patients with forearm/elbow fracture are planned to include in this study.     Patients will be randomly attained Training or Control group. Training period will be six     weeks. Patients in the control group will receive standard care for provided for fractures,     including fixation and rest.Before the start of the study and after six weeks, bilateral bone     density of distal radius will be measured by DXA. Before trials, grip strength and the rest     muscle electrical activity of contralateral wrist flexors and extensors will be measured.     After six weeks, bilateral grip strength and the rest muscle electrical activity will be     measured.   "
132285|NCT01553474|"     Background:      - The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study     participants will provide blood and saliva samples. The samples will be stored for research     on eye diseases.      Objectives:      - To collect blood and saliva samples for AREDS 2 research.      Eligibility:      - AREDS 2 research study participants.      Design:        -  Participants will provide blood and saliva samples.        -  The samples will be submitted with personal and medical information. This information          will be collected during the AREDS 2 procedures.   "
132286|NCT01553461|"     Background:      - Cord blood transplants can treat cancers and other diseases in children and adults. The     U.S. Food and Drug Administration (FDA) requires cord blood to be collected and stored under     certain safety standards. However, most available cord blood units were collected before the     FDA set these standards. These units may not meet FDA standards, but they do meet similar     standards set and followed by the National Marrow Donor Program (NMDP). Cord blood units that     do not meet the new FDA standards may be used for transplants only as part of a research     study. Doctors want to allow people who need transplants to receive cord blood that meets     NMDP standards but may not meet FDA standards.      Objectives:      - To allow selected cord blood units that do not meet current FDA standards to be used for     transplant.      Eligibility:      - Individuals who need cord blood units for transplant, and who best match cord blood units     that are not FDA-licensed.      Design:        -  Participants will provide consent to receive cord blood that meets NMDP standards but          may not meet FDA standards.        -  Participants will remain on the study for observation for up to 1 year after transplant,          or until they withdraw from the study for personal or medical reasons.   "
132287|NCT01553448|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial studies gene expression in samples from younger patients with     neuroblastoma.   "
132288|NCT01553435|"     Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods     analgesia and tolerance in Pediatric Intensive Care Unit Patients   "
132289|NCT01553422|"     This study assess the relation between intra abdominal pressure and collapsibility index of     inferior vena cava in emergency bedside ultrasonography before and after fluid therapy.   "
132290|NCT01553409|"     The investigators want to investigate the effects of blood donation to blood pressure, to     iron metabolism and oxidative stress.      There are results of other studies that show, that there is a positive effect of blood     donation to high blood pressure, iron metabolism and oxidative stress.   "
132291|NCT01553396|"     This study shows an evaluation of the correlation between the muscle strength levels and     functional autonomy of elderly women.   "
132292|NCT01553383|"     Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime     sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP)     valve Provent in obstructive sleep apnea. The hypothesis is the efficacy will be better     than dental device.   "
132310|NCT01553149|"     This randomized phase II trial studies how well low-dose lenalidomide works compared with     high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or     optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment     (refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may     stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known     whether low-dose lenalidomide is more or less effective than high-dose lenalidomide in     treating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.   "
132311|NCT01553136|"     The purpose of this study is to determine whether varenicline is effective in the treatment     of alcohol dependence in smokers.   "
132293|NCT01553370|"     Maintaining a healthy body weight is a major challenge for the majority of Canadians. A     lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most     importantly, can be incorporated into daily life with relative ease is essential. This study     will determine if an effective strategy includes increased physical activity in conjunction     with higher intakes of dairy products immediately following exercise. Fifty-six overweight     adult males who do not regularly exercise will be assigned to one of four groups for 12     weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5     times per week). Two groups will consume supplemental low fat milk (3 servings per day) with     one these groups consuming it immediately after exercise while the other will consume it     either well before or long after the exercise session. The other two groups will consume a     carbohydrate drink that has the same amount of energy as the low fat milk, with one of these     groups consuming the drink right after exercise and the other another group will consume it     either well before or long after the exercise session. Markers of health status including     body weight, muscle mass, and bone mass will be measured at the start and after the 12- week     intervention. The investigators anticipate that providing the low fat milk immediately after     exercise will result in the most favorable changes in health outcomes, and provide a     realistic lifestyle intervention for overweight individuals to attain a healthy body weight,     and by doing so, optimize their ability to prevent chronic disease.   "
132294|NCT01553357|"     This is an open label, multicenter, exploratory, single arm, two-stage study aiming to     explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line     therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).   "
132295|NCT01553344|"     The aim of this study is to determine serum sclerostin levels and change in serum sclerostin     levels in patients with Vitamin D deficiency treated with calcium and vitamin D.      Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with     calcium and vitamin D will be included in the study. This is an observational study. The     serum sclerostin levels will be measured before and after Vitamin D treatment.   "
132296|NCT01553331|"     Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting     at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another     option. The aim is to test the hypothesis that with ultrasonic dissection technique a better     same day discharge and a shorter operative time can be achieved.   "
132297|NCT01553318|"     The purpose of this 10-week study is to determine the effects of a medication called     Ketotifen on pain sensitivity; and fibromyalgia-related pain.      Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that     are known to cause inflammation. It is an antihistamine that reduces the harmful effects of     histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food     and Drug Administration (FDA) and has been available in the United States for more than a     decade. Oral (taken by mouth) ketotifen has been in available in other countries for several     decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis,     ketotifen has long track record of safety. To date, the oral form of ketotifen has not been     approved by the FDA, therefore this study is referred to as an investigational drug study.     Prior to opening recruitment an investigational new drug (IND) application which included     scientific data and information regarding human safety plans was submitted to and approved by     the FDA.   "
132298|NCT01553305|"     The purpose of this study is to compare the effectiveness of a supervised high-intensity     exercise programme followed by an unsupervised exercise programme to an unsupervised exercise     programme in patients with Rheumatoid Arthritis.   "
132299|NCT01553292|"     Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called     ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is     needed to adapt the use of large volume surfactant of 4-5 ml/kg.      The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada     called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation     suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on     CPAP.   "
132300|NCT01553279|"     Primary objective      • To evaluate the concomitant administration of PR5I with two types of MCC vaccines (MCC-TT     and MCC-CRM)      Secondary objectives      Part I        -  To describe the immunogenicity of PR5I when PR5I is given at 2 months of age and          concomitantly with MCC vaccines at 3 and 4 months of age        -  To describe the immunogenicity of MCC vaccines when MCC vaccines are given concomitantly          with PR5I at 3 and 4 months of age (post-dose 1 and post-dose 2)        -  To describe the safety of PR5I given concomitantly with PCV-13 and MCC vaccines      Part II      • To describe the immunogenicity and safety of Hib-MCC when given at 12 months of age in     subjects who have received PR5I at 2, 3 and 4 months of age   "
132301|NCT01553266|"     The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education     Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's     effectiveness in improving patient clinical and care process outcomes.      The study's hypotheses are that the MDET intervention results in the following outcomes:        -  Improvement in patient clinical outcomes;        -  An increase in the proportion of primary care physicians (PCPs) performing patient care          processes according to clinical practice guidelines;        -  An increase in the proportion of referrals to, and patients' utilization of, diabetes          education programs (DEPs).   "
132302|NCT01553253|"     Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the     first week after the operation is a predictive factor for the development of chronic pain,     but it is unknown whether the risk is more related to one of the different components of     acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been     systematically described in terms of type of pain or sensory abnormalities etc. (allodynia,     hyperalgesia etc.).      The purpose of the study is to examine whether intensity of components of acute pain is     predictive for development of chronic pain after cholecystectomy and to characterize the     chronic pain by quantitative sensory testing.      DNA-samples are collected to examine genetical factors, important for perception of pain, and     the development of chronic pain.   "
132312|NCT01553123|"     The purpose of this study is to determine whether ulipristal acetate is effective in the     treatment of females with anemia associated with uterine leiomyomas. The safety of this     product will also be evaluated.   "
132304|NCT01553227|"     Sleep Apnea Hypopnea Syndrome (OSAHS), is common in patients with OHS, compared to single     Obesity Hypoventilation Syndrome (OHS) or OSAHS ,patients with both of them are more     susceptible to have serious hypoxia and carbon dioxide retention during sleep, and much more     likely to result in pulmonary hypertension and cor-pulmonale.      At present, the most widely and valid method for these patients is the Bilevel Positive     Airway Pressure (BiPAP) ventilation, while, recently, the investigators discovered a     completely novel device, namely auto-trilevel Ventilator. In contrast to the traditional     therapy, auto-trilevel Ventilator has a more flexible expiratory positive airway pressure     (EPAP), with which it can removing residual obstructive sleep apnea hypopnea events and     correcting hypercapnia without contradiction. Treated with auto-trilevel ventilator may delay     the progression of disease and improve life quality. The overall purpose of this study is to     determine the curative effects of auto-trilevel ventilators on patients with OHS and OSAHS.   "
132305|NCT01553214|"     Background:      - White blood cells called granulocytes help the body fight infection. People who have had     chemotherapy or bone marrow transplants may have very low numbers of these cells.     Transfusions of these cells can help improve the body's ability to fight infection. However,     most of the cells are located in the bone marrow or spleen, and are hard to collect from     healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the     bloodstream to be collected by apheresis. Researchers want to study the best ways to collect     these white blood cells. They also want to monitor the effects of the injections and     donations on the volunteer donors.      Objectives:      - To improve the amount and quality of granulocytes (white blood cells) collected by     apheresis for donation.      Eligibility:      - Healthy volunteers between 18 and 75 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Initial blood          tests will be done to check for eligibility.        -  Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year.          Donations will not usually be requested more often than every 4 weeks. Donors will be          allowed to decline participation at any time.        -  Participants will have one injection of filgrastim 12 to 24 hours before donation. They          will also have two tablets of dexamethasone 12 hours before donation.        -  White blood cells will be collected through apheresis. The apheresis will last about 2          hours.        -  Participants will be eligible to donate until they reach their 76th birthday.   "
132306|NCT01553201|"     Background:      - Some women with endometriosis have chronic pelvic pain. This pain may be caused by spasms     of the pelvic floor muscles. These spasms can be detected by an examination. Studies suggest     that botulinum toxin can help treat problems caused by muscle spasms. Researchers want to see     if botulinum toxin injections into the pelvic floor muscles can decrease pain and spasms in     women with pelvic pain.      Objectives:      - To see if botulinum toxin can relieve pain from pelvic floor spasm in women with pelvic     pain.      Eligibility:      - Women between 18 and 50 years of age with pain associated with pelvic muscle spasm and     endometriosis. Pain must be persistent (lasting for at least 3 months).      Design:        -  Participants will keep a pain diary and record their pain medication use for a month          before the first visit.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Participants will also answer questions about their pain          levels and quality of life.        -  Participants will receive either botulinum toxin or a placebo (salt water) injection.          The injection will be given into the pelvic floor muscles through the vaginal wall.          Participants will take a muscle relaxant like Valium and have anesthetic cream put on          the vaginal wall before the injection.        -  After the injection, participants will keep a pain diary for another month.        -  At a 1-month followup visit, participants will answer questions about their pain. If the          pain has not improved, all participants may have a botulinum toxin injection (no          placebo) into the pelvic floor muscles as before.        -  Participants will have followup visits for up to a year after the initial 1-month          followup visit.   "
132307|NCT01553188|"     Background:        -  Advanced prostate cancer is treated with surgery or drugs that lower the levels of          androgens (male hormones) in the body. However, some cancers become resistant to this          treatment. These types of cancers are known as castration-resistant prostate cancers.        -  Interfering with the growth of blood vessels that feed tumors can slow prostate cancer          growth. AMG 386, a new anticancer drug, targets the blood vessels that feed tumors. It          has been tested for different types of cancer, but not for prostate cancer. Researchers          want to see if AMG 386 can slow disease progression in men with castration-resistant          prostate cancer. AMG 386 will be given with abiraterone and prednisone, two drugs that          are also used to treat advanced prostate cancer.      Objectives:      - To test the safety and effectiveness of AMG 386 with abiraterone for castration-resistant     prostate cancer.      Eligibility:      - Men at least 18 years of age with castration-resistant prostate cancer.      Design:        -  Participants will be screened with a physical exam, medical history, and imaging          studies. Blood and urine samples will also be collected.        -  Participants will be separated into two groups.        -  The first group will have AMG 386 once per week for a total of four doses during a          28-day cycle. They will also take abiraterone once a day and prednisone twice a day,          every day of the cycle.        -  The second group will not have AMG 386. They will take abiraterone once a day and          prednisone twice a day, every day of the 28-day cycle.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Participants will continue to take the study drugs as long as the disease does not          progress and there are no severe side effects.   "
132308|NCT01553175|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and find biomarkers related to     cancer. It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial studies gene expression in samples from patients with rhabdoid     tumors.   "
132309|NCT01553162|"     RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples     from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.   "
132313|NCT01553110|"     This is a study to learn more about the common cold from studying the nasal secretions     produced during a cold or episode of allergic rhinitis.   "
132315|NCT01553084|"     The overall purpose of this research is two-fold. First, the two smoking cessation medication     treatments with the strongest evidence of effectiveness have never been directly compared.     This research will determine how these two treatments compare in effectiveness in a     head-to-head trial, and which types of smokers benefit most from each. Second, much of the     data on smoking and health come from studies from many years ago. Today's smokers differ from     earlier smokers in many ways that could influence the impact of smoking on health (e.g.,     weight, sex, diet, socio-economic status); the proposed work will determine how smoking     cessation affects cardiovascular and pulmonary health in today's smokers.   "
132316|NCT01553071|"     In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that     causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides, has     been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide precursor.     This phase I study represents the first clinical trial employing this promising combination.     The drug administration schedule (fenretinide given on Days 1-5, safingol given on Days 1-2     of each 21-day cycle) reflects the in vitro observation that tumor cell exposure to safingol     increased fenretinide efficacy both during and after safingol administration. The total dose     of fenretinide, 4600 mg/m2 over 5 days, represents a 30% total dose reduction from the single     agent MTD dose of 1280 mg/m2/day x 5 days determined on the PhI-42 study. This fenretinide     dose is expected to produce plasma levels in the 30?s ?M. This dose reduction has been     employed to reduce the potential for overlapping hepatic toxicities between these two agents.      The administration of a reduced fenretinide dose on Day 1 (600 mg/m2 on Day 1, escalated to     1000 mg/m2/day on Days 2-5) has been selected due to earlier observations that initial     exposure to the soy bean oil vehicle in the fenretinide emulsion may induce endogenous     lipases, thereby permitting tolerance of higher total doses fenretinide emulsion subsequently     administered. The starting dose of safingol in this study, 210 mg/m2/day x 2 days (420 mg/m2     total), corresponds to 50% of the recommended Phase II safingol dose (bolus) determined in     the Schwartz, et al, Phase I study of safingol plus cisplatin 60 mg/m2 (the MTD of     single-agent, intravenous (emulsion) safingol was not reached in the Phase I safingol run-in     monotherapy portion of this study), and was selected to provide an adequate safety margin     against the potential for overlapping toxicities (such as hepatic transaminitis).      The study has been designed to optimize the safety of this novel combination. Treatment will     be administered in the inpatient setting. Central venous access will be mandated to avoid the     potential for hemolysis and thrombophlebitis associated with the preclinical peripheral     administration of a previous safingol formulation in rats. To reduce the incidence of     hypertriglyceridemia, a revised fenretinide delivery schedule will be employed. Patients will     also be encouraged to maintain a low-fat diet during fenretinide administration. Serum     triglycerides will be monitored every 12 hours. To monitor for cardiac toxicity, which was     noted in canine studies at the highest dose of safingol plus fenretinide tested, serum     troponin T levels will be monitored daily. To limit the potential for hepatotoxicity     resulting from a possible drug interaction observed between intravenous fenretinide,     ceftriaxone and acetaminophen in a pediatric patient, the concurrent administration of     ceftriaxone, or acetaminophen, with the fenretinide emulsion infusion will be prohibited.   "
132317|NCT01553058|"     The purpose of this study is to assess the effect of adalimumab (Humira), when compared to     NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may     resemble an active substance but has no medical value) injection. The study will compare the     effects of each on systemic inflammation and cardiovascular disease risk factors in subjects     diagnosed with moderate to severe psoriasis.      This study will look for systemic vascular inflammation in subjects with a test called     FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study     will also look for cardio metabolic (heart disease and metabolic factors such as diabetes)     identifiers in the blood. A blood sample will be taken that will look for these markers     identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move     in the body), metabolic factors, and inflammation.      This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB     phototherapy or placebo injection on psoriasis activity and severity. The study will also     compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This     study will also evaluate subjects' reported outcomes through a questionnaire that will assess     quality-of-life in subjects living with psoriasis.   "
132318|NCT01553045|"     Atrial fibrillation is the most common cardiac arrhythmia. There is a large variation in     symptoms; from almost none to severe but the reason for this is unclear.      The investigators aim to find correlations between symptom burden and intracardiac pressure,     biomarkers and findings with echocardiography in order to find alternative means of     treatment.      It is even intended to study the neurohormonal activation directly after the atrial     fibrillation (AF) initiation in patients eligible for AF radiofrequency ablation.   "
132319|NCT01553032|"     This is a national multicenter phase IV study to assess acute radiation dermatitis of     combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced,     non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).   "
132320|NCT01553019|"     The purpose of this study is to find out what effects, good and/or bad, proton radiation     combined with chemotherapy has on resected pancreatic cancer.   "
132321|NCT01553006|"     Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about     the efficacy of this drug at low and high doses.   "
132322|NCT01552993|"     The aim of this study is to see if paracetamol has a pain-relieving effect during eye     examination in premature infants.   "
132323|NCT01552980|"     This is an open-label, phase II study to evaluate the efficacy and safety of a modified     regimen of oxaliplatin and S-1 on unresectable gastric adenocarcinoma in the first-line     therapy.   "
132324|NCT01552967|"     This is an open-label, phase II study to evaluate the efficacy and safety of a modified     regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the     first-line therapy.   "
132325|NCT01552954|"     Purpose of this study        1. Intensive education for low salt diet will be enhance the anti-proteinuric effect of          Olmesartan, a popular anti-hypertensive drug of angiotensin II receptor blocker, in          Koreans compared to conventional prescription of medication.        2. Intensive education for low salt diet will decrease the amount of 24 hour-urine sodium          excretion compared to control group, effectively.   "
132326|NCT01552941|"     This is a 12 week open label pilot study to determine the efficacy and safety of a surgically     implanted, electrically active vagal nerve stimulation device in patients with active     rheumatoid arthritis.   "
132327|NCT01552928|"     According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated     for their ability to prolong the QT interval which represents the duration of ventricular     depolarization and subsequent repolarization. The primary objective of the study is to assess     the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose     of anagrelide when compared to placebo and a positive control.   "
132328|NCT01552915|"     The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in     adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).   "
132329|NCT01552902|"     The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in     adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).   "
132338|NCT01552785|"     A comparison of three different devices using near infrared spectroscopy to measure the     regional oxygenation. Both absolute values, reproducibility of measurements and sensitivity     to changes will be estimated. The study hypothesis is that NONIN EQUANOX 7600 with sensor     Model 8004CA, INVOS 5100c with sensor SAFB-SM and FORE-SIGHT with medium sensor have similar     characteristics.   "
132339|NCT01552772|"     This study will test the safety of an aripiprazole injection in subjects with schizophrenia     that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in     this study will receive one injection of aripiprazole and will need to stop taking their     other antipsychotic medication two weeks after the injection. The study will last one month.     Subjects will be required to come to a clinic for evaluations and drug and urine collection     five times during the course of the study.   "
132340|NCT01552759|"     This study investigates the hormones that the body produces in response to food intake and in     response to stress, and the way that stress influences food intake. In particular, it     compares the hormone levels and food intake of people with and without binge eating disorder.     In order to find out how these appetite- and stress-related hormones are linked to brain     activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which     regions of the brain are most active during a food-related scenario.   "
132341|NCT01552746|"     Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain     is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is     believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1     year after surgery, but it is unknown if it is related to acute postoperative shoulder pain.      The purpose of the study is to systematically describe postoperative shoulder pain after     lobectomy and examine the time progress up to 1 year after surgery.   "
132342|NCT01552733|"     Weakness and impairment of the upper limb is a common contributing factor to post stroke     disability. Specially designed robotic systems have been developed to try to improve this.     The investigators already know that their use helps improve limb function after stroke when     it has been present for many months. The investigators do not know whether they can help     early after stroke and enhance recovery of limb function, and perhaps prevent weakness     becoming chronic.      The investigators plan a randomised controlled blinded study to explore the benefits of robot     assisted therapy early after stroke in 80 stroke survivors. Participants will be randomised     by 7 days after stroke to standard care or to robotic therapy (40 participants per study     group).      Standard of care will be rehabilitation therapy according to local guidelines delivered by     NHS multidisciplinary team.      Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in     first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a     series of taks including circle-drawing, reaching targets and holding/moving against moderate     resistance. Twelve sessions of therapy within the first 4 weeks after randomisation will be     delivered. This study will take 3 years to complete.   "
132343|NCT01552720|"     Data reported by the international registry of acute aortic dissection (IRAD) in not     sufficient to reflect clinical characteristics of acute aortic dissection in China. Moreover,     clinical characteristics of Acute aortic dissection have not evaluated to data. The aim of     this study is analyze changing trend of clinical characteristics of Chinese patients with     acute aortic dissection.   "
132344|NCT01552707|"     The present prospective, randomized study, compares the spinal fusion obtained after     instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from     his/her own bone marrow which will be fixed in human bone tissue form a donor), with the     current procedure that consists in instrumented spinal fusion and the use of each patient's     bone obtained from his/her iliac crest.      The working hypothesis proposes that the tissue engineering is a valid and useful technique     to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its     associated morbidity.   "
132345|NCT01552694|"     People living with human immunodeficiency virus infection (HIV) have 2-4fold greater risk for     developing diabetes and heart disease than the general population. They need safe and     effective treatments that reduce the risk for developing diabetes and heart disease, and     improve their quality of life. This project will explore whether a new anti-diabetes     medication (Januvia) with a novel mechanism of action reduces inflammation, and improves     blood vessel function in HIV infected men and women with several risk factors for developing     cardiovascular disease.   "
132346|NCT01552681|"     The purpose of the study is to find out if the experimental study agent, baminercept, is     effective in treating patients with Sjögren's syndrome. The study will also determine if the     study agent can be safely given to patients with Sjögren's syndrome; examine how it affects     symptoms of the disease; and attempt to understand how baminercept affects the underlying     mechanisms of Sjögren's syndrome and the immune system.   "
132347|NCT01552668|"     The purpose of this research study is to evaluate the effectiveness of an antibiotic called     fidaxomicin in preventing C. difficile infection.   "
132363|NCT01552460|"     The purpose of this study is to explore the effects of genes and genetic variation on brain     structure and function. Investigators at Harvard plan to explore the relationship between     candidate genes that affect cognitive performance and brain structure/function. Since brain     phenotypes reflect more proximal sequelae of gene activity, neuroimaging measures may show     greater sensitivity than cognitive performance to measure gene effects.   "
132364|NCT01552447|"     The purpose of this study is to determine whether the EpiFix human amniotic membrane is     effective in the treatment of venous leg ulcers.   "
132348|NCT01552655|"     The purpose of this study is to elucidate the value of dual-time-point PET/CT in the     recurrence of breast cancer and to determine whether the method is better than the modalities     used in the standard work up.      150 patients with suspected breast cancer recurrence will be included. All patients will     undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After     completion of the examinations the early and the late PET/CT scan will be compared with each     other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious     findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained,     the presence of recurrence will be verified with additional imaging follow-up to ensure the     highest possible confidence. Sensitivity, specificity, accuracy, negative and positive     predictive value (NPV/PPV) will be calculated for each modality (incl. early and late     PET/CT).   "
132350|NCT01552629|"     The study will assess the safety and efficacy of QGE031 in the treatment of moderate to     severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured     and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of     the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already     established as being effective in atopic dermatitis.   "
132351|NCT01552616|"     Critically-ill patients who have long stays in the hospital often face prolonged periods of     bed rest. It is known that these patient develop profound weakness and debilitation. The     effectiveness of existing muscle activation devices that could otherwise prevent the onset of     debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is     hypothesized that using thermal methods to augment existing muscle activation techniques may     demonstrate improved performance with no corresponding change in the safety profile.   "
132352|NCT01552603|"     The purpose of this study is to verify an automated system of blood glucose control in Type I     Diabetics. The automated system consists of the investigational Artificial Pancreas Control     software (APC), two blood glucose sensors, and two hormone pumps, one for delivering insulin     to lower blood sugar, and the second for delivering glucagon to raise blood sugar. The blood     glucose sensors relays information to the Artificial Pancreas software, which uses the     Adaptive Proportional Device algorithm to determine the rate of insulin and glucagon infusion     by the hormone pumps. In prior studies, the Adaptive Proportional Device algorithm has been     verified, but required manual input into the computer and hormone pumps. This study differs     in that it uses a fully automated system under the control of the Artificial Pancreas Control     software. The importance of this change is that it is the next step to enable outpatient use     of automated, closed loop blood glucose control.   "
132353|NCT01552590|"     This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum     sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and     hyponatremia   "
132354|NCT01552577|"     The purpose of this study is to develop and validate eye-tracking measures that can be used     to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).   "
132355|NCT01552564|"     This study investigates the association between the microvascular resistance at the time of     primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of     myocardial damage.   "
132356|NCT01552551|"     Older adults at high risk of falls will complete the PA Healthy Steps program. This program     will be implemented by research staff who will follow the training manual and implement the     program as it was designed to assess the effectiveness of the program. Participants will then     be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which     adherence to physician and home safety assessments will be facilitated; and (iii) Healthy     Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All     participants will be followed monthly for 6 months through personal and automated telephone     interview protocols to ascertain falls and injuries.   "
132357|NCT01552538|"     This will be an open label multicenter study of the safety and efficacy of an active     implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis.     Patients who complete study SPM-005 will be enrolled in this study at the time of the last     visit of the preceding study.   "
132358|NCT01552525|"     The purpose of the study is to determine the association between acute kidney injury and     serum levels symmetrical and asymmetrical dimethylarginine (SDMA/ADMA) and their assumptive     influence on mortality, renal function and on arterial stiffness.   "
132359|NCT01552512|"     This randomized, controlled effectiveness study examines Nutributter programming within an     integrated package of maternal and child health services offered by Haiti's Ministry of     Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process     evaluation is to better understand the uptake of Nutributter® as a complementary food in the     diets of young children and its feasibility and acceptability as part of MSPP's package of     services. This project is being carried out at a public hospital in Fort San Michel, an     impoverished community outside of Cap Haitien, Haiti.   "
132360|NCT01552499|"     The purpose of this study is to determine whether the EpiFix human amniotic membrane is     effective in the treatment of diabetic foot ulcers.   "
132361|NCT01552486|"     Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary     to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in     outcome. The composition of the non-operative treatment of this patient population remains     poorly defined. Spinal manipulative therapy (SMT) has demonstrated value in the treatment of     AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic benefit through the     modulation of in vivo inflammatory mediators. This feasibility study will define the key     experimental variables required to conduct a large multicentre study that will clarify the     biological and clinical outcomes of SMT in the treatment of patients with AS/LDH.   "
132362|NCT01552473|"     This study is being done to improve the ability to diagnose and to achieve higher-levels of     functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain     Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12     months).   "
132365|NCT01552434|"     The goal of this clinical research study is to find the highest tolerable dose of Avastin     (bevacizumab) and Torisel (temsirolimus) that can be given in combination with either     valproic acid or cetuximab to patients with advanced cancer that is refractory. The safety of     this drug combination will also be studied.      Bevacizumab is designed to block the growth of blood vessels, which may help to slow or block     the growth of cancer.      Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to     die.      Valproic acid is an anti-seizure drug that may be able to activate tumor-fighting genes,     causing cancer cells to die.      Cetuximab is designed to block a certain protein, called EGFR, that is thought to cause     cancer cells to grow. This may cause cancer cells to die.   "
132408|NCT01551862|"     A prospective study on 50 consecutive patients who are going to have a lower body lift     procedure is performed. Measures include comorbidities and complications. Risk factors     assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max),     current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.   "
132366|NCT01552421|"     Uncomplicated laparoscopic cholecystectomy will in most patients result in moderate to severe     pain until the first postoperative day. This will subside during the second and third     postoperative day [1]. A feeling of low general well-being will also be present until the     first postoperative day and subside during the next couple of days [2].      To achieve faster recovery after laparoscopic interventions it has been shown that a     reduction in the size of laparoscopic ports and thereby incisions can reduce postoperative     pain [3,4].      A new minimal invasive surgical technique is based on the principle of completely eliminating     the use of ports through the abdominal wall. This new technique is called Natural Orifice     Transluminal Endoscopic Surgery (NOTES) and is defined by acquiring minimal invasive access     to the abdominal cavity through the body's natural openings like the mouth and stomach, anus,     urethra and vagina. With the NOTES technique one can completely avoid incisions in the     abdominal wall and thereby reduce the surgical trauma. The benefits of this technique is a     reduction of postoperative pain, elimination of incisional hernias, prevention of wound     infections, reduction of peritoneal adherence formation, achieving a faster recovery and a     better cosmetic result [7,8].      The most documented and well-described way for gaining NOTES access to the abdominal cavity     is through the vagina, transvaginal (TV). TV NOTES has mainly been used for cholecystectomy     because of the direct line of vision to the upper abdomen and gallbladder that is achieved     through this opening.      Compilation of results show that TV NOTES cholecystectomy can be implemented with low     complication rates [20-22]. One retrospective case-control and one prospective observational     study report less postoperative pain, reduced consumption of analgesics and faster recovery     for TV NOTES compared to conventional laparoscopic cholecystectomy [23,24]. To date there are     no systematic prospective randomized data on whether or not TV NOTES cholecystectomy leads to     a better surgical outcome.      In the present study the postoperative course after TV NOTES cholecystectomy will be compared     to laparoscopic cholecystectomy in a prospective randomized and blinded trial. The outcome of     the randomization between the two surgical techniques will be blinded to patient and the     nurse staff for the first 72 hours after the operation. The primary outcome parameter will be     postoperative pain score during the first 24 hours. Secondary outcome parameters are     postoperative pain score for the first 72 hours, fatigue, well-being, nausea, consumption of     analgesics, complications, cosmetic result and sexual function.      The hypothesis being that TV NOTES cholecystectomy gives less postoperative pain, fatigue and     nausea, a reduction in analgesics and a better cosmetic result and general well-being than     conventional 4 port laparoscopic cholecystectomy.   "
132367|NCT01552408|"     This study is a Phase I/II, multicenter, randomized, study of the efficacy and safety of     ranibizumab injection monotherapy verses a duel therapy of 0.3mg ranibizumab combined with     ultra wide, 200° field angiography guided pan retinal photocoagulation in patients with     CSME-CI secondary to diabetes mellitus (Type 1 or 2).   "
132368|NCT01552395|"     A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice   "
132369|NCT01552382|"     We will use a retrospective data analysis to evaluate the association of vitamin D status     with clinical outcome in cardiac surgical patients. The occurrence of several postoperative     adverse events such as myocardial infarction, low cardiac output syndrome, stroke and     in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will     assess the association of vitamin D status with the duration of mechanical ventilatory     support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital     stay will be assessed according to vitamin D status.   "
132370|NCT01552369|"     This is a study of two different approaches for the prevention of CMV disease in liver     transplant recipients. The primary purpose is to determine if Preemptive therapy is the same     or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative     recipients that receive a CMV positive liver transplant. Patients meeting study criteria and     who have provided informed consent will be randomized within 10 days of transplant to receive     in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once     daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV viremia by     plasma PCR) for 100 days with initiation of oral valganciclovir 900mg orally twice daily only     at onset of CMV viremia and continued until plasma PCR is negative on two consecutive weekly     PCR tests.   "
132371|NCT01552356|"     This phase I trial studies the side effects and the best dose of pazopanib hydrochloride in     treating patients with solid tumors that has spread to other places in the body and usually     cannot be cured or controlled with treatment (advanced) or does not respond to treatment     (refractory). Pazopanib hydrochloride may prevent the growth of new blood vessels that tumors     need to grow. Studying samples of blood in the laboratory from patients receiving pazopanib     hydrochloride may help doctors learn more about the effects of the body on the drug. It may     also help doctors understand how well patients respond to treatment.   "
132372|NCT01552343|"     The purpose of this study is to assess psychometric properties (reliability and validity) of     the Nocturia Impact (NI) diary.      To assess the association between reduction of number of nocturnal voids and the mean changes     in NI scores (sensitivity of the NI total score to change in nocturia).      To assess which NI diary items account for the main difference in change in total NI score in     treatment versus placebo.   "
132373|NCT01552330|"     The observed changes of P. falciparum sensitivity to artemisinin lead to the intensification     of early detection as well as treatment monitoring in malaria infection. It is widely     accepted that the development of resistance can be delayed by the use of combination therapy,     especially combinations that include artemisinin derivatives (acts). As the resistance     problem is considered extremely serious; as a consequence, who has recommended that all     monotherapy for malaria should be stopped.      Current WHO guidelines recommend that the drug combination regimens using ACT with effective     partner medicines should be used to decrease the risk of development or spreading of     artemisinin resistance.   "
132396|NCT01552018|"     Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve glycaemic     control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone     glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased     insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in     atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and     chemokines associated with atherosclerosis/inflammation.      The purpose of this study is to explore the effects of 3 months intervention with DPP-4     inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable     coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in     circulating monocytes and adipose tissue.      A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic     effect of DPP-4 inhibitors beyond glycaemic control alone.      Due to reduced sample size (recruitment problems) the main focus has changed and will now be     on cellular aspects and gene regulation (initially secondary outcome measure).   "
132409|NCT01551849|"     The purpose of this study is to evaluate echocardiographic markers of cardiac function to     assess the ability of patients to successfully end VA-ECMO support.   "
132425|NCT01551641|"     The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients     by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer     receiving chemoradiotherapy were divided into different sub-group according to dynamic change     of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at     random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were     evaluated, and at the same time, activity of thalidomide on esophageal cancer and its     clinical safely were assessed.   "
132374|NCT01552317|"     Patients with kidney disease benefit from reducing the amount of salt in the food that they     eat. The benefits include lower blood pressure and better kidney function. Therefore,     lowering the amount of salt that is eaten could reduce the number of people who will develop     kidney failure. The effect on blood pressure could also reduce the number of strokes and     heart attacks. Similar benefits are also seen for people without kidney disease.      Guidelines for patients with kidney disease recommend that they lower the amount of salt that     they eat, but most patients do not manage to do this. The reasons for this are not unclear,     but are likely to reflect the difficulty that patients have in reducing the amount of salt in     their food and the nature of the advice that they are given.      The investigators have developed a package of interventions to help patients to make     healthier choices that will lower their salt intake. The package helps patients to learn     about salt in food and how to avoid it. It provide practical advice on cutting down on salt     using information booklets, text messages, emails, telephone calls, and a website.      Participants will be recruited from hospital kidney clinics and general practice. The     investigators will randomly allocate participants to receive either the normal care that they     would get or to receive the new package of interventions to help them lower salt. The package     of interventions will involve patients receiving text messages, telephone calls, emails and     written information. They will complete a questionnaire and collect urine samples which will     can be used to measure the amount of salt that they are eating. No more than 6 visits will be     required. The study is funded by the British Renal Society which is a charity that funds     research to help patients with kidney disease.   "
132375|NCT01552304|"     Hypotheses:        1. Postoperative oxygen therapy significantly improves postoperative oxygenation in OSA          surgical patients.        2. Postoperative oxygen therapy do not significantly increase the number of apnea episodes          and the duration of apnea episodes.        3. Postoperative oxygen therapy do not significantly increase arterial carbon dioxide(CO2)          level in OSA surgical patients.   "
132376|NCT01552291|"     Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic     diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress     immune function, exaggerate stress response and cause organ system dysfunction. Increased     susceptibility to infection, protracted wound healing, impaired blood clotting and vessel     wall fragility have been shown to be the leading causes of postoperative morbidity and     mortality in malnourished patients undergoing major surgical resections.      This trial is designed as a prospective randomized, double-blinded, placebo-controlled pilot     study in a academic single center in Switzerland. A total of 50 malnourished patients with     gastro-intestinal tumors will receive orally glutamine or placebo-treatment during a period     of 5 days prior to surgery. The investigators hypothesize that oral Glutamine administration     is feasible, well tolerated, will decrease postoperative morbidity, will suppress     postoperative cell damage and inflammatory response, and will improve the perioperative     immunocompetence of the patients.   "
132377|NCT01552265|"     This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who     convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the     conversion.   "
132378|NCT01552252|"     The null hypothesis tested was that there are no differences in the taste palatability of the     apple juices before and after adding POs-Ca.   "
132379|NCT01552239|"     RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to     minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by     HDR-brachytherapy in patients with positive margins after tumor resection.      PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern     radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue     (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in     treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.   "
132380|NCT01552226|"     This is a prospective randomized study of 114 patients. The purpose of this study is to     compare the efficacy of two standard methods of analgesia for pain control in patients     undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and     by the need for supplemental narcotic analgesics. This study is designed to determine if     postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q     Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).   "
132381|NCT01552213|"     The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for     pregnant women with prediabetes decreases the rate and severity of impaired glucose tolerance     later in pregnancy and improves perinatal outcomes. Given the rising rates of obesity and     diabetes in this country even among young women and the adverse affects of diabetes of     pregnant women and their infants, the investigators feel that it is important to not only     identify women at high risk for diabetes early in pregnancy but determine the appropriate     management strategy   "
132382|NCT01552200|"     The purpose of this study is to compare the additional diagnostic yield obtained by     performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard     colonoscopy procedure.   "
132383|NCT01552187|"     This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of     colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention,     and post-operative atrial fibrillation prevention.   "
132384|NCT01552174|"     The purpose of this study is to determine the incidence and characteristics of eyelid     inflammatory disorders during general ophthalmological consultations and to demonstrate     association between palpebral pathologies and ocular surface pathologies.   "
132385|NCT01552161|"     The purpose of this study is to estimate the prevalence of allergic diseases and atopy among     patients with angiographically confirmed coronary artery disease as well as to assess levels     of serum allergic inflammation markers in this population.   "
132397|NCT01552005|"     The purpose of this study is to respond to The French Health Authority which has requested     BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a     representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with     Saxagliptin to generate real world data on drug utilization, joint population, non     comparative effectiveness and safety   "
134301|NCT01526941|"     This trial is conducted in Europe. The aim of this trial is to compare the single dose and     steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in     subjects with type 1 diabetes.   "
132386|NCT01552148|"     Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing     elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine     requirements during the first 24 hours postoperatively.      Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:        1. Group treatment TAP (n=23) will receive the following analgesia:             -  US guided transversus abdominis plane block performed with 40ml of 0.375%               levobupivacaine (20 ml per side) after general anaesthesia induction, before               surgical start             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at               rest        2. Group control will receive:             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at               rest      Primary Outcome Measures:      Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control      Secondary Outcome Measures:        -  Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain          when resting in bed and during cough during the first 24 hours postoperatively        -  Time to PACU dimission, evaluated as patient's achievement of a White's score > or =          12/14        -  Time to home discharge, evaluated as patient's achievement of a PADDS score > or = 9        -  Functional patient capacity as measured before surgery and whenever a White's score > or          = 12 will be reached (2minute walking test)        -  Eventual side effects such as nausea/vomiting   "
132387|NCT01552135|"     The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin when     the skin is intact and when the skin is sunburned. The hypothesis is Does nanotitandioxide     penetrate intact or sunburned skin?   "
132388|NCT01552122|"     This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral     density in osteoporotic postmenopausal women who were previously treated with alendronate.   "
132389|NCT01552109|"     The purpose of this study is to describe the clinical profile and current status of the     diagnosis and management of stable angina in India by non-interventional consulting     physicians (CP) through a large multicenter observational registry.   "
132390|NCT01552096|"     The investigators postulate that the use of pre-incisional peritonsillar infiltration of     tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic     consumption, without harmful effects. Therefore, the present study is designed to evaluate     the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum     protein, C-reactive protein, and analgesic consumption after tonsillectomy.   "
132391|NCT01552083|"     The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea     screening program for patients at risk in community pharmacies.   "
132392|NCT01552070|"     The purpose of this study is to investigate the change of extravascular lung water (EVLW),     cytokine and oxygenation parameters in patients with acute lung injury (ALI) or acute     respiratory distress syndrome (ARDS) after alveolar recruitment maneuver.   "
132393|NCT01552057|"     The purpose of the study is to assess the effectiveness and safety of duloxetine in     participants with fibromyalgia.   "
132394|NCT01552044|"     The objective of the study is to evaluate the effect of spironolactone on 16 patients     presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate     whether spironolactone can resolve sub retinal fluid in these patients.      CSCR is a major cause of visual loss in the young population. It is characterized by sub     retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes     of the disease remain unknown but a choroidopathy has been suggested. Moreover,     corticotherapy and stress are known risk factors of CSCR.      Our preclinical studies have demonstrated that the mineralocorticoid pathway could be     involved in the control of choroidal blood flow.      The investigators propose to evaluate the mineralocorticoid receptors antagonist     spironolactone in the treatment of CSCR.      Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint:     visual acuity gain ≥ 15 EDTRS letters   "
132395|NCT01552031|"     Chronic obstructive pulmonary disease (COPD) is a pathological condition whose progression is     characterized by stable periods broken up by intermittent acute exacerbations of the     symptoms, during which a severe inflammatory process occurs often requiring hospitalization.     During exacerbations the risk of death is very high making the social and economical impact     of such events important.      The need of rationalize the utilization of health care resources together with the     optimization of patient's care has prompted the development of models of assistance based on     home monitoring. At the present time most of the suggested models were based on the     utilization of diaries for symptoms perceived by the patients. Even if positive results are     reported in terms of reduction of in hospitalization many COPD patients tend to underestimate     the severity of their condition and their compliance in recording their symptoms rapidly     decreases with time.      Attempts of using more objective measurements such as home spirometers have been done but     poor results were reported mainly due to the difficulties in performing a spirometric test     without medical supervision.      A more suitable approach to get objective information on the function of the respiratory     system is the Forced Oscillation Technique (FOT). Such methodology is based on the analysis     of the response of the system to small pressure stimuli over-imposed to the normal breathing     of the patients. The measurements require minimal cooperation and can be performed without     medical supervision.      The purpose of this study is to measure daily variability of FOT data measured at home of a     group of COPD patients in order to identify possible correlations between symptoms change,     breathing pattern, lung mechanical impedance and occurrence of exacerbation.   "
132406|NCT01551888|"     The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and     tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall     Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for     five days to patients with moderate to severe COPD.   "
132407|NCT01551875|"     This non-interventional, prospective, multi-centric, cross-sectional study is aimed to obtain     the distribution of measurements of CIMT in Indian subjects and will involve approx. 30     investigative sites from all over the country. Each investigative site will be expected to     enrol 50 subjects and Carotid intima-media thickness (CIMT) values will be taken for each     individual as described in the protocol.      All the procedures could be completed in a single day, however due to any reason any study     variable is not taken subject may be asked to come back for a second visit within 7 days of     the first visit.   "
132398|NCT01551992|"     1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh     attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,     Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™,     Ethicon, Somerville, NJ, USA).      1.2 SECONDARY OBJECTIVE - To compare laparoscopic sacrocolpopexy anatomic failure rates at 6     months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture     (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed     absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess     mesh erosion rates, costs, and surgeon satisfaction rates.      2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with     self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals,     Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using     0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).      2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1     barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver,     Canada) will be less costly than the standard fixation interrupted technique using 0     non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).      2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.      2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based     on subjective surgeon satisfaction questionnaires.   "
132399|NCT01551979|"     The aim of this study is to look at the effectiveness of repetitive transcranial magnetic     stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary     outcome is improvement in negative symptoms related to schizophrenia. The investigators are     focusing on negative symptoms given their greater resistance to pharmacological and other     established therapies. If the investigators trial were to show beneficial effects, its     clinical significance would be great.   "
132400|NCT01551966|"     The portal hypertension (PHT) is the main complication in patients presenting with cirrhosis.     It can be the direct cause of bleeding by rupture of the esophageal or gastric varices and     can also contribute to the development of ascites, hepatic encephalopathy and pleuropulmonary     complications.      In the paediatric population presenting with the PHT, one of every two children develops     varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule     endoscopy (VCE) is now routinely used in children for the exploration of the small bowel. But     the role of the VCE for examination of the other parts of digestive tract still needs to be     evaluated.      For the esophagus, the VCE could allow the diagnosis without the need of general sedation.     Recent studies have shown a good sensitivity and tolerance of this technique for the initial     diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension,     but it has not yet been validated for this indication.      The investigators hypothesize that the VCE could be used in children with similar results in     term of efficacy, as for adults.      This prospective simple blind multicentre study (blind for the lecture of the capsule     endoscopy record), will investigate the diagnostic value of the VCE compared to the     conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and     the control of esophageal varices in children.      If it is provided that the VCE is as efficient as it is for the adults, it could become a     very interesting alternative to the conventional EGD because less expensive and less     invasive. Moreover, this technique would be very useful as a means of early detection on the     EV and/or their control.   "
132401|NCT01551953|"     The main purpose of this study is to determine feasibility and effects of tai chi and     mind-body breathing in patients with COPD.   "
132402|NCT01551940|"     Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral     sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in     parotids and submandibular glands. The investigators want to demonstrate 1 month after the     injection, by a multicenter French randomized double blind study, an improvement of at least     25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a     decrease of the quantity of saliva and a decrease of the embarrassment for the main     caregiver.   "
132403|NCT01551927|"     Aim: To investigate and compare women's and men's expectations before investigation and     treatment of suspected coronary artery disease and to examine how these expectations are met.      Do women and men, of different ages, have the same expectations for the evaluation and     treatment of stable coronary artery disease and are their expectations met in a equal degree?      Are there differences in expectations and the fulfilment of these according to age and other     clinical history variables? Do the findings in the specially developed questionnaire designed     to gather patients' expectations to the outcome on quality of life and degree of angina     pectoris relate to their appearance in the designated forms? Is there a relationship between     NTproBNP - levels, as a measure of cardiac workload, and expectations and the fulfilment of     these as well as the quality of life and degree of angina pectoris?      Method: Patients will be asked to participate in the study, in the context of medical     consultation before coronary angiography by a physician and / or a study nurse. This occurs     during an outpatient visit at the cardiac clinic at the respective centre. Included are all     patients planned for elective coronary angiography before possible revascularization during a     eight month period regardless of diagnosis. Including are four hospitals in the region of     Västra Götaland.   "
132404|NCT01551914|"     The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon     Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy)     by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to     conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary     objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii)     postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques     (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs     and medical outcomes and (vii) an estimation of the potential impact of new technology on the     organization of operating rooms (operating time).   "
132405|NCT01551901|"     The purpose of this trial is to evaluate the performance, safety and effectiveness of the     Luna system for the treatment of degenerative disc disease.   "
132426|NCT01551628|"     The purpose of this study is to determine whether Recombinant Human Arginase 1 (rhArg1)is     safe and effective in the treatment of patients with Relapsed or Refractory Leukemia or     Lymphoma.   "
132410|NCT01551836|"     This will be a single centre, open label, randomised, two-way crossover study in healthy     volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in     this study to establish at what time point a therapeutic concentration of paracetamol in the     blood is reached. Subjects will attend a screening visit to check if they are eligible for     study participation then within 15 days they will check-in to the unit for a stay of     approximately 48 hours (hrs). They will be given a single dose of one of the preparations on     the first day and then the other preparation on the next day. Regular blood samples will be     taken along with other assessments for safety.   "
132411|NCT01551823|"     The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus     Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains     Preservative.   "
132412|NCT01551810|"     The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus     Vaccine (Split Virion, Inactivated) that do not contains Preservative .   "
132413|NCT01551797|"     This proof of principle study will evaluate an experimental formulation of paracetamol that     is being developed for eventual long lasting use. This study is also used for drug safety     evaluation.   "
132414|NCT01551784|"     The aim with this study is to investigate the effect of statin induced changes in HDL-C on     all cause mortality and CVD with adjustment for changes in other blood lipids and clinical     parameters in Sweden, UK and the Netherlands.   "
132415|NCT01551771|"     This study is the first administration of GW824575 in humans. This will be a single centre,     masked, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics     (PK) and pharmacodynamics (PD) of GW824575, given as single and repeated oral doses to     healthy male subjects. The study will be comprised of 4 parts and enroll approximately 40     subjects: Part A will consist of two cohorts of 8 healthy male subjects to assess the safety,     tolerability, PK, and PD of ascending single oral doses of GW824575. All available safety,     tolerability, and PK data will be monitored prior to each dose escalation. In order to     support the possible indication for age-related macular degeneration (AMD), Part B will be     one cohort of 12 subjects to examine the safety, tolerability, PK, and PD of a repeated dose     of GW824575 over 21 days in healthy male subjects who are greater than or equal to 50 years     of age. The total daily dose in this cohort will not exceed the maximum tolerated dose (MTD)     from Parts A and D. Subjects in this cohort will undergo ophthalmology assessments before     receiving investigational product and after Day 7 of the 21-day in-patient treatment, after     steady state has been reached. As part of protocol amendment 2, Part C (Cohort 4) is removed     from the protocol. Part D, added under protocol amendment 2, will consist of one cohort of 12     healthy male subjects to assess safety, tolerability, PK, and PD of ascending single doses of     GW824575 as well as the effect of food on the PK of GW824575.   "
132416|NCT01551758|"     This study is designed to compare the effectiveness and safety of Fluticasone     Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg     Vilanterol ((VI), GW642444)) delivered once daily via a Novel Dry Powder Inhaler (NDPI)     compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed     with COPD. This is a Phase III multi-centre, randomised open label study. Subjects who meet     the eligibility criteria are randomised and will enter a 12 month treatment period.   "
132417|NCT01551745|"     This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab.     All patients will have had Vigil™ prepared and stored from initial primary surgical     debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7     cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2     weeks.   "
132418|NCT01551732|"     The purpose of this study is to determine whether adding an interactive biofeedback video     game to anger control cognitive behavioral therapy is an effective and feasible treatment.   "
132419|NCT01551719|"     The general objective of the study is to assess whether the implementation of the antibiotic     essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of     infection may improve the outcome of infections compared to using only the standard     procedures.   "
132420|NCT01551706|"     This is a Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of     ENI Patented Whole Grape Extract on Antioxidant Status.   "
132421|NCT01551693|"     STA9090 is a drug which inactivates or blocks the work of a protein called Heat Shock Protein     90 or HSP90. HSP90 is a protein that helps some molecules inside your cells to have the right     shape. By stopping HSP90's activity, those molecules never get to have the right structure of     be functional and they are destroyed. The investigators believe that if they stop the     activity of HSP90, the rapidly dividing cells that are in your tumor(s) may slow down. In     this research study the investigators are looking to see how well STA9090 works in stopping     the spread of your melanoma.   "
132422|NCT01551680|"     Recent pre-clinical and clinical data have indicated that BSI-201 does not possess     characteristics typical of the PARP inhibitor class. Based on the results from in vitro and     in vivo studies, this trial aims to evaluate the combination of BSI-201 concomitantly with     radiotherapy in patients who present with multiple non operable brain metastases. As     radiotherapy is a local treatment targeting only the tumor, and because the molecule BSI-201     has shown no major toxicity against tissues without DNA alterations, the proposed combination     is expected to provide tumor-selective therapy and leading to a clinical benefit improvement.      Primary objective is to determine the recommended phase II dose (RP2D) and evaluate acute     toxicity (CTC-AE v4.0 grading scale) of concurrent administration of whole brain radiotherapy     (WBR) and a small molecule BSI-201 in non operable brain metastases.   "
132423|NCT01551667|"     The primary objective of this study is to detect differences in anti-S. aureus antibody     assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due     to a chronic wound (cases) and (2) a group of patients with localized chronic wound     infections (control).   "
132424|NCT01551654|"     Colonoscopy is a stressful and unpleasant procedure especially during the passage of the     endoscope through angulations of colon. Electro-acupuncture is one of the alternative to     reduce colorectal discomfort. However acupuncture is invasive. This present study explored     the effectiveness of a non-invasive treatment modality, Transcutaneous Electrical Nerve     Stimulation over Acupuncture points in reduction of colorectal discomfort during     barostat-induced rectal distension.   "
132431|NCT01551563|"     The study aims at studying the outcomes of a protocol-based handling of newly diagnosed     Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a     descriptive study and no hypothesis is predefined.      Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating     purposes.   "
132432|NCT01551550|"     This is a multi-site randomized clinical trial to evaluate the long-term efficacy of the     thicker amniotic membrane graft (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) in reducing shunt     tube exposure in patients undergoing glaucoma drainage device implantation.   "
132433|NCT01551537|"     This PMS study aims to collect safety and reactogenicity data of Cervarix in the local     population as per the licensing requirement of the Sri Lankan regulatory authority.   "
132434|NCT01551524|"     This study is an open label, multicenter study with a dose escalation of Asparec®     administered once every two to four weeks for two administrations. The primary objective of     this study is to determine the Maximum Tolerated Dose following one single dose of Asparec     when administered in a population of patients with relapsed or refractory hematological     malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which     are to evaluate the safety of Asparec and to determine the PK profile as assessed by     measurement of plasma L-asparaginase enzymatic activity following single and repeated doses     of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be     measured.   "
132435|NCT01551511|"     Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and     long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as     first choice in pain management of CP, resulting in regularly prescription of opioids. The     adverse consequences of prolonged opioid use, including addiction, tolerance and opioid     induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to     treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive     substance of the cannabis plant, has been shown in previous studies to be a promising     analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an     improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of     Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy     of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain     resulting from CP.   "
132436|NCT01551498|"     This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc     dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid     function in subjects with autoimmune thyroiditis.   "
132437|NCT01551485|"     Sleep after surgery has been found to be very distrubed immediately after major surgery. This     is also seen after fast-track hip and knee replacement with length of stay of less than 3     days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and     decline in cognitive abilities.   "
132438|NCT01551472|"     The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using     Vitamin E UHMWPE tibial inserts for total knee replacement surgery.   "
132439|NCT01551459|"     Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer     spreads, it is more difficult to treat.      Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine,     but they are always looking to find new ways to treat uveal melanoma.      This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how     long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.   "
132440|NCT01551446|"     This study is to evaluate the variability of several pharmacodynamic measures of kidney     function, cardiovascular function, cerebral perfusion, and haemodynamics.   "
132441|NCT01551433|"     The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal     of a portion of the stomach and esophagus with re-attachment) there is an association between     the intraoperative level of oxygen at the site where the esophagus is re-attached to the     stomach (measured using the Wipox), and the incidence of a disruption at the site of the     attachment after the surgery.   "
132442|NCT01551420|"     The overall study objective is to examine the feasibility, acceptance, and benefits of home     use of an advanced upper limb prosthetic device as well as the logistical support     requirements utilized during 3 months of home usage. All participating subjects will enroll     in Part A of the study which will involve supervised training. Eligible subjects will be     invited to participate in Part B, the home use portion of the study.   "
132444|NCT01551394|"     This phase III multicentric international randomized trial is designed to compare the     efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical     or confirmed late-onset sepsis (LOS).      The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well     known and documented in this population.   "
132445|NCT01551381|"     The principal objective of this study is to evaluate the safety and tolerability of repeated     doses of EV-077-3201-2TBS given to diabetic subjects over a 4 week treatment period. The     secondary aim of this initial Phase IIa study is to evaluate the effect of multiple oral     doses of EV-077-3201-2TBS on platelet function, vascular function, vascular inflammation,     vascular oxidative stress, renal function and a selection of exploratory parameters and     biomarkers in type 2 diabetic subjects, as well as multiple dose pharmacokinetics in diabetic     subjects.      In order to ensure the safety of the diabetic subjects, initial parts of the study will     evaluate the safety and tolerability of EV-077-3201-2TBS. In Part A, the safety of different     doses EV-077-3201-2TBS will be investigated in healthy subjects treated for 4 weeks. In     parallel, Part B will investigate potential interactions between EV-077-3201-2TBS and ASA in     healthy subjects. Part C will then investigate the safety, pharmacokinetics and     pharmacodynamics of EV-077-3201-2TBS in type 2 diabetic subjects with and without concomitant     ASA therapy.   "
132455|NCT01551251|"     The purpose of this study is to investigate the effects of tumor associated macrophage (TAM)     in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome     of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining     methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed     between high or low TAM.   "
132456|NCT01551238|"     The purpose of this study is to determine energy expenditure and sleep in response to     protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of     time.   "
132446|NCT01551368|"     Nimodipine (Nimotop® Bayer Pharmaceuticals Corporation), unlike other calcium channel     blockers is fat soluble and therefore is able to cross the blood-brain barrier1. Gonadotropin     releasing hormone (GnRH) neurons are clustered in the hypothalamus and are dependent on     calcium flux to release GnRH responsible for the release of follicle-stimulating hormone     (FSH) and luteinizing hormone (LH) from the anterior pituitary. In a natural menstrual cycle     a spontaneous LH surge occurs mid-cycle which triggers ovulation. The investigators     hypothesized that nimodipine, by blocking calcium channels, may effectively suppress the     release of GnRH and consequently the natural LH surge.      In this prospective double-blinded randomized study the investigators will evaluate the     efficacy of nimodipine to inhibit the natural LH surge in women undergoing controlled ovarian     stimulation (COS) and intrauterine insemination (IUI). Nimodipine, if successful, may     represent an inexpensive oral medication as an alternative to the currently used GnRH     agonists or GnRH antagonists in assisted reproductive technologies like IVF.   "
132447|NCT01551355|"     As part of the Colombian Hearty Health Initiative program led by Mount Sinai Cardiovascular     Institute, a multidisciplinary team design and implemented a pedagogic and communication     strategies for the promotion of healthy heart habits (PPHH) in preschoolers. This included     educational materials, pedagogical activities and the use of Sesame Workshop healthy habits     for life materials. For Colombia, the latter were largely developed in collaboration with the     Colombian Society of Pediatrics, Colombian Society of Cardiology and Cardiovascular Surgery,     Colsubsidio and Fundación Cardioinfantil-Instituto de Cardiología.   "
132448|NCT01551342|"     -  This study includes two semi-consecutive parts:             -  Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect®               device for identifying bladder cancer cells in urine samples.             -  Part II Prospective, controlled, blinded part to determine the performance of the               CellDetect® device in monitoring bladder cancer recurrence in patients with a               history of TCC, using urine cytology samples        -  The following subjects will be enrolled:      Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic     surveillance, TURT or Cystectomy.   "
132449|NCT01551329|"     The purpose of this study is to evaluate the efficacy of ketamine in reducing depressive     symptoms in subjects with a comorbid major depressive episode and alcohol dependence. The     investigators hypothesize the following for the present study:      A single dose of ketamine will induce a rapid, robust and sustained reduction in depressive     symptoms in subjects with a comorbid major depressive episode and alcohol dependence relative     to placebo as defined by change in Hamilton Depression Rating Scale total scores at 72 hours     post infusion.      A single dose of ketamine can be delivered safely, with minimal adverse events or     complications, in subjects with a comorbid major depressive episode and alcohol dependence.   "
132450|NCT01551316|"     In MediciNova's clinical development plan for MN-221, it was recognized that treatment of     COPD exacerbations may necessitate more than one single i.v. infusion and that patients in     this population may have more co-morbidities (and concomitant medications) than has been     generally studied so far. Thus, the primary objective of this clinical study is to determine     the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to     placebo with repeated administration over several days in moderate to severe COPD patients     who may also have co-morbidities and concomitant medications (CM) common in this population.     Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).      This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year     (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human     clinical trial information.   "
132451|NCT01551303|"     The purpose of this study is to learn more about how emotional processing may be affected by     a hormone called oxytocin. Oxytocin is a hormone that occurs naturally in the body, and may     play an important role in the way that the brain perceives information.   "
132452|NCT01551290|"     The purpose of this study is to evaluate the effectiveness and safety of infliximab in     Chinese patients with active ulcerative colitis (swelling and ulceration of large intestine     and rectum).   "
132481|NCT01550900|"     The goal of this clinical research study is to learn if metformin extended release (ER) can     prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a placebo.      Metformin ER is designed to block a protein in tumor cells that is important in tumor growth     and blood vessel development. This may cause cell death or reduce the spread of the disease.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
132482|NCT01550887|"     This study main objective is investigating impulsivity on cocaine or crack addicts. The     investigators main hypothesis is that different measures (such as scales or behavioral tasks,     for example) of impulsivity may produce distinct outcomes, and they might also differ among     cocaine (sniffed) and crack users. Thus, it would be of great value to compare such measures     once these data are often interpreted as the same phenomenon.   "
132453|NCT01551277|"     Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the     distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized     clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two     groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n =     16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung     ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright     spirometer. GBS held three techniques with an interval of three minutes. The GC used the same     circuit without the occlusion of the expiratory branch. Results: GBS was found to be higher     in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and decrease     in abdominal compartment (p = 0.03), whereas the CG showed no difference in distribution.     Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no difference before     and after the technical BS and GBS in the GC. Conclusions: The technique BS altered the     distribution pattern of regional ventilation, resulting in greater contribution in lung     volume in the lower rib cage, corresponding to activity of the diaphragm, with redistribution     of volume between compartments.   "
132454|NCT01551264|"     Prolonged bracing reduces the rate of clubfoot recurrence. In addition to bracing length,     other factors, including compliance with bracing, gender, age, severity of clubfoot deformity     and family history contribute to clubfoot recurrence.   "
132457|NCT01551225|"     This study will be executed according to a randomized double-blind placebo-controlled trial     with two parallel groups, treated over the period of 6 months with escitalopram or placebo.      Hypotheses: Escitalopram is more effective than placebo in the control of gastrointestinal     symptoms, in irritable bowel syndrome (IBS) patients with panic disorder. Escitalopram is     more effective than placebo in the control of psychiatric symptoms, in IBS patients with     panic disorder.   "
132458|NCT01551212|"     This trial will evaluate the efficacy of Everolimus in combination tacrolimus versus a     standard immunosuppressive regimen concerning kidney function in liver transplant recipients.   "
132459|NCT01551199|"     To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure     Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid     posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase     of the study will examine the feasibility and acceptability of MCET-V.   "
132460|NCT01551186|"     The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus     GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in     patients on a ventilator.   "
132461|NCT01551173|"     This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release     Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C     lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or     mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when     treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.   "
132462|NCT01551160|"     Patients in hospital can have unexpected clinical emergencies. When this occurs the Medical     Emergency Team (MET) are called with the intention of resolving the problem. Previous     investigations have found that patients who have more than one call during their admission     have worse outcomes than patients who only have one call. But it has not been established     why.      The aim of this research will be to examine these repeated calls and why patients subject to     them go on to have worse outcomes. A predictive model will be developed to identify potential     sources of risk. One potential source is poor communication between health care providers. An     intervention to improve communication around MET calls may provide benefit to patients and     improve outcomes.   "
132463|NCT01551147|"     The primary objectives are        -  to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on          early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled          allergen        -  to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days          in patients with asthma      The secondary objectives are:        -  to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following          allergen exposure, and        -  to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced          airway hyperresponsiveness (AHR) as measured by methacholine challenge   "
132464|NCT01551134|"     The aim of the study was to compare short- and longterm outcomes after laparoscopic and open     Nissen fundoplication in children.   "
132465|NCT01551121|"     3 Nursing homes in the Limousin region will be equipped with the automated telesurveillance     system. Patient will be selected by general practitioner and randomized into two groups after     informed consent. One group will have cameras installed and the other will not and will act     as a comparison group. Patient will be assessed three times during the study, at inclusion, 6     months and 12 months. Each assessment is composed of a standard geriatric assessment, a fall     questionnaire, an autonomy scale (SMAF scale) and a quality of life questionnaire (EQ5D).     Every falls will be considered as adverse events and will therefore be listed along the study     and characterized in types and number.   "
132466|NCT01551108|"     This study is designed to determine if parents can deliver an intervention that will help     increase physical activity in their children. The parents will be given the intervention     through their mobile phones.   "
132467|NCT01551095|"     This research is being done to study the safety of an investigational percutaneous endoscopic     gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube     prevents it from slipping back into the stomach.   "
132468|NCT01551082|"     Discharging patients home with air leak and chest tube to portable drainage device after     thoracic resection is cost effective and safe without compromising patients outcome or     satisfaction. Despite good outcomes this practice is not done universally by thoracic     surgeons.   "
132469|NCT01551069|"     Primary Objective:      - To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily     regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus     (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous     Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4) concomitant     treatment with or without corticosteroid.      Secondary Objectives:        -  To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of          once daily regiment of HCQ versus placebo as the reference group in patients with CLE          and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant          treatment with or without corticosteroid.        -  To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in          patients with CLE and SLE with active skin manifestation concomitant treatment with or          without corticosteroid.        -  To investigate the safety and efficacy of 52 weeks long-term treatment of once daily          regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose          reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with          corticosteroid        -  To investigate efficacy of once daily regimen of HCQ on systemic symptoms,          musculoskeletal symptoms and immunological parameters in SLE patients.   "
132470|NCT01551056|"     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in     the conjunctival allergen challenge (CAC) model.   "
132471|NCT01551043|"     The primary objective is to determine the safety and survival of the redirected allogeneic T     cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).   "
133057|NCT01543347|"     This study is aimed at demonstrating the efficacy of temocillin in the treatment of     complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases     (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom.   "
132472|NCT01551030|"     The purpose of this study is to learn what effects, good and/or bad, Buparlisib has on     advanced urothelial cancer. Buparlisib is a pill that works by shutting down some of the     signals in cancer cells that make tumors grow. It is being tested in patients in research     studies such as this one. As of 2010, more than 80 patients with various types of cancer have     received treatment with Buparlisib in research studies.      This clinical research study is divided into two parts. The goal of the first part of this     study is to learn if the study drug Buparlisib can shrink or slow the growth of cancer in     patients with urothelial tumors. The goal of the second part of this study is to learn if the     study drug Buparlisib can shrink or slow the growth of urothelial tumors in patients known to     have certain genetic alterations that cause these types of tumors. The study doctor will     inform the patient which part of the study is currently enrolling participants. Participants     in both parts of the study will receive the same treatment and tests.      The safety of this drug will also be studied in both parts. The physical state, changes in     the size of the tumor, and laboratory findings taken while on-study will help us decide if     Buparlisib is safe and effective.   "
132473|NCT01551017|"     Fast Track Recovery Arthroplasty Project is supposed to analyse a new medical method to     accelerate patient's remobilisation process after total knee endoprostheses. The method,     called c-treatment, is a computer-controlled cryotherapy (soothing cooling therapy) at which     the device measures temperature at the affected site (the operated knee in the investigators     investigation) and optimizes the cooling temperature. The optimized cooling therapy is     supposed to reduce swelling and postoperative pain whereby patient's postoperative     mobilization can be done earlier leading to a reduction of length of hospitalization.      To verify c-treatment's efficiency compared to conventional cryotherapy, patients are split     in a test group and a standard group. The standard group is treated following the standard     protocol at the Department of Orthopaedics Surgery Graz using cold packs (Fa. Dahlhausen,     product code 93.000.00.042). Patient's in the test group receive c-treatment therapy     following the study protocol.      All patients are instructed to fill in standardized questionnaires to evaluate social scores     and pain scores preoperative as well as postoperative. The knee's swelling and range of     motion as well as blood parameters monitoring the healing process are measured following the     study protocol.      The comparison of these parameters between the standard and the test group is supposed to     verify c-treatment's efficiency.   "
132474|NCT01551004|"     Double-blind, randomized, placebo-controlled Phase I Trial to determine the safety and     pharmokinetics of a single dose of CRS3123 in healthy adult volunteers. Forty healthy male     and female subjects 18 to 45 years will be admitted in 5 dosing Cohorts, 8 subjects per     Cohort. Up to two alternates may be used per dosing Cohorts for study subjects that drop out.     The primary objective of the study is to determine the safety and tolerability of escalating     doses of CRS3123 following oral administration to healthy subjects. The secondary objective     is to assess whether there is measurable systemic exposure and if so, to determine the plasma     pharmacokinetic characteristics of CRS3123 after a single oral dose.   "
132475|NCT01550978|"     The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system     during the course of mechanical ventilation and intubation of critical care patients in     Intensive Care Unit.   "
132476|NCT01550965|"     This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in     participants with ulcerative colitis (UC).   "
132477|NCT01550952|"     Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain.     Commonly, patients receive general anesthesia with interscalene block (injection of local     anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of     the interscalene block, patients often experience sensory and motor blockade. The purpose of     this study is to determine the effects of the interscalene block on the anterior deltoid     muscle and hand grip strength after total shoulder arthroplasty.   "
132478|NCT01550939|"     The objectives of this study are to determine the time needed to complete a full set of     measurements (Total Ophthalmic Exam, Subject Data Entry and Acquisition of the Measurement)     by each test device, the Lenstar 900 Version i4 and IOL Master 500.   "
132479|NCT01550926|"     The purpose of this study is to determine whether a new dosage form and dose of orlistat is     equivalent to the currently marketed form.   "
132480|NCT01550913|"     This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT)     in treating women with depression and comorbid substance abuse.   "
132483|NCT01550874|"     Hypothesis: The investigators hypothesize that a pedometer-based motivated 6-months walking     program will result in sustainable enhanced PA.   "
132489|NCT01550796|"     The purpose of this research study is to determine if a medication along with a computer     program designed to improve memory and other mental processes can help people like yourself     with tinnitus. The medication that will be investigated, d-cycloserine, was developed as an     antibiotic. However, more recently, research in other studies has shown that this medication     may enhance learning and memory. The investigators would like to determine if computer     programs designed to improve memory and attention are enhanced by this medication. In     addition, the investigators hope to learn if the use of these programs can help participants     with their tinnitus as well as their ability to remember and focus. All research participants     will receive therapy with a computer-based program designed to improve memory and attention.     Half of participants will also receive d-cycloserine while the other half of participants     will receive placebo. The placebo is a sugar pill without active medication.   "
132490|NCT01550783|"     This randomized clinical trial studies home-based HPV or clinic-based Pap screening for     cervical cancer. It is not yet known whether home-based screening is more effective,     cost-effective, and/or acceptable than clinic-based screening for cervical cancer.   "
132491|NCT01550770|"     Exploration of the hypothesis that general anesthesia is not a singular threshold but is a     continuum of central nervous system depression dependent on interpretation of nociceptive     stimuli.   "
132872|NCT01545752|"     Using different methods of electronic learning has been increasingly developed by emerging     electronic educational technologies. They could apply on the net, CDs, Mobile, etc in     different usage alternatives: interactive and non-interactive both in online and off-line     approaches. In this educational trial, the interactive and non-interactive CD-based method     for teaching medical terminology to nursing students of MUMS school of nursing and Midwifery     during 2009-2012 was compared.   "
132492|NCT01550757|"     Aligning Resources to Care for Homeless Veterans (ARCH) will study ways to best organize     and deliver primary care for homeless Veterans. The investigators will assess 4 different     adaptations of the PACT primary care model in a mixed methods study that includes     multi-center, randomized-controlled trials of embedded peer-mentoring within different     iterations of the PACT model, focus groups of study participants assessing satisfaction,     treatment engagement and self-efficacy within the different care models and a cost-utility     analysis to determine the most cost-efficient approach to organizing care for this     population. Findings from this study will help determine optimal care approaches for reducing     emergency department visits and acute hospitalizations, increasing patient satisfaction, and     improving chronic disease management. Findings from this study will also substantively add to     our understanding of health seeking behavior and the care of vulnerable/high-risk Veteran     populations as well as clinical systems design. This project reflects a true field-based     study to identify optimal and feasible approaches to patient care within our current VHA     system. Finally, it will help inform pressing policy issues relevant to two identified T-21     priority areas: Ending Veteran Homelessness in 5 Years and Transforming to a Patient Centered     Primary Care model.   "
132493|NCT01550744|"     The purpose of the study is to assess the effect of extending maintenance dosing intervals     beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with     moderate-to-severe plaque psoriasis.   "
132494|NCT01550731|"     Millions of diverse Veterans live with severe and chronic illness for which they will face     complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered     chronic care, interventions to prepare Veterans for complex decision-making over the course     of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a     novel preparation guide designed to prepare Veterans to communicate with their surrogates and     to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches     communication and preparation skill behaviors (e.g., how to choose a surrogate and ask     clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th     grade reading level). This study aims to provide an impetus for changing the paradigm of     advance care planning policies within the VA by moving beyond documentation of end-of-life     wishes to the activation of Veterans to participate in ongoing communication of their values     and goals - a process that is essential to fully realize patient-centered care.   "
132495|NCT01550718|"     Alzheimer's disease (AD) is increasing exponentially, with a projected quadrupling of cases     by the mid 21st century. Individuals with AD are at increased risk for a host of medical and     psychiatric conditions, and evidence is accumulating supporting the efficacy and     effectiveness of psychosocial interventions for improving their mood, function, health, and     quality of life. Such interventions are likely to be most effective when they are implemented     during the early stages of dementia, when individuals and their family members are coping     with the initial diagnosis and associated changes in abilities and activities. Recent     randomized clinical trials by the Principal Investigator and colleagues have developed two     non-pharmacologic interventions to reduce the social, psychological, physical, and behavioral     impact of dementia. This investigation is focused on facilitating their translation into     ongoing community-based programs, such as those provided by Alzheimer's Association chapters,     senior centers, retirement homes, and other health care providers. The core content of each     intervention has been retained in order to maintain or improve their efficacy, and each has     been modified to a 4-week group format to increase efficiency of delivery. These modified     interventions (ESML-Social and ESML-Ex) will be compared to each other and to a usual care     (UC) control group. Outcomes will be assessed at baseline, 1-month post treatment, and 4     month follow-up. Primary outcomes at the 1-month assessment include: social activity     participation, family communication, physical activity participation, and physical function.     Primary outcomes at 4-month follow up include overall quality of life and depression. It is     hypothesized that ESML-Ex and ESML-Social both will have greater improvements than UC. It is     hypothesized that ESML-Social will have greater improvements in social participation and     family communication than ESML-Ex and UC. It is hypothesized that ESML-Ex will have greater     improvements in physical activity participation and physical functioning than ESML-Social and     UC. If successful, these 4-week programs may be developed into modules that can be     incorporated into programming for individuals with early stage dementia in a variety of     community settings.   "
132496|NCT01550705|"     In erythropoietic protoporphyria there is an accumulation of protoporphyrin IX (PPIX) in the     plasma and liver. The reason it builds up is either the last step to make heme, insertion of     iron into PPIX, is rate limiting or there is an increase in activity in the first step in the     heme pathway.      It may be possible to decrease the amount of PPIX made and see a decrease in symptoms. The     first step to make heme is the key step in the pathway and it uses vitamin B6 as a cofactor.     If the investigators can limit the amount of vitamin B6 the investigators can possibly reduce     the activity of this rate limiting step. With decreased activity of the enzyme it may be     possible for the body to utilize all the PPIX that is made so that none builds up.   "
132529|NCT01550263|"     This is an investigatory study to determine whether high levels of pre-operative     psychological distress predict worse outcomes after hip preservation. This is a low risk     study and does not alter the treatment or course of care for patients undergoing this     procedure   "
132602|NCT01549301|"     The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects     of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or     intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects     through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of     serum levels of G-CSF and absolute neutrophil count - ANC).   "
132497|NCT01550679|"     Even though the main risk factor for the development of chronic obstructive pulmonary disease     (COPD) is smoking only in less than one third of the smokers the clinically manifest COPD     will develop. The disease progressive nature with high disability and mortality especially in     the final stages makes it plausible to detect the disease as early as possible thus allowing     for the early intervention. Major intervention trials in COPD, Towards a Revolution in COPD     Health (TORCH), Investigating New Standards for Prophylaxis in Reducing Exacerbations     (INSPIRE), and Understanding Potential Long-term Impacts on Function with Tiotropium     (UPLIFT) have recently shown that the beneficial impact of intervention was larger in     patients being treated in earlier stages of the disease development. Till now the only tool     for an early diagnosis and early intervention that could be used on the global scale was     spirometry even though symptoms and deprivation of quality of life (QoL) precedes clinically     relevant spirometric changes. So there is a need for a new simple tool that would allow     detection of patients in a very early stage of COPD.      So the aim of this study is the development of diagnostic tools for an early detection of     COPD, even before the significant change in spirometry.   "
132984|NCT01544569|"     RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory     may help doctor learn more about changes that occur in DNA and identify genes related to     cancer.      PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid     tumors.   "
132498|NCT01550666|"     People with schizophrenia often have problems with negative symptoms; expressing and     identifying their emotions, their amount of speech, motivation and interests, feelings of     purpose, social skills, and experiencing enjoyment. For this reason, new interventions are     being developed to treat these problems. One new intervention is the Motivation and     Engagement (MOVE) Program. The MOVE program is a new program which consists of weekly     meetings for 9 months between a patient and a trainer. The weekly meetings will consist of     goal setting and organization of the home to make daily tasks more manageable. During the     weekly meetings the patient and trainer will discuss emotions and the trainer will help the     patient identify their emotions.      The researchers hope to learn whether MOVE will help improve the problems. If it works the     researchers will do a larger study comparing MOVE to other treatments that have addressed     some of the problems already.      The therapist will ask you if the sessions can be audio taped to ensure that the therapist is     doing a helpful job for you. They will also ask if the session can be video taped so that the     tapes can be used to train other therapists learning about MOVE. The choice to do either of     these is voluntary and you can continue to participate in the study if you choose not to have     the session be audio and/or video taped.You will be provided a University Release document to     provide that permission if you so choose.   "
132499|NCT01550653|"     This study examines the hypothesis, that subcutaneous administration of liraglutide, an     analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in     healthy humans.   "
132500|NCT01550640|"     Caesarean delivery under general anaesthesia (GA) carries nowadays still 25% risk of     insufficient depth of anaesthesia in a time before the fetus delivery. The reason is the lack     of opioid administration. Opioids easily cross placental barrier and negatively influence     newborn postpartum adaptation by respiratory depression. Introduction to GA is thus     accompanied by exaggerated autonomic stress reaction with hypertension and tachycardia. The     use of ultra-short acting opioid remifentanil should suppress stress response in mother     without increasing the risk for newborn. There are only a few clinical data available. This     study will be the first one systematically studying the influence of remifentanil in pregnant     women with hypertension on hemodynamic stability and newborns safety. This study will also     identify potential pharmacogenetic factors of individual variability in remifentanil response     with respect of drug efficacy and safety in mother and newborn.   "
132501|NCT01550627|"     The aim of the study was to evaluate the influence of a systematic extra intravenous fluid     supplementation during phototherapy in comparison to a fluid supplementation due to short     term demand in preterm infants.   "
132502|NCT01550614|"     The purpose of this study is to determine whether a single intracoronary infusion of     Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial     perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8     weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary     endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.   "
132503|NCT01550601|"     The bariatric surgery is recognized, at present, as the only effective therapeutic for the     patients with morbid obesity. Two surgical procedures (said restrictive) are considered as     consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring     périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy     (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008). It     consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/-     antrum). However, lot of technical disagreements are brought back by expert teams. The most     important disagreement concerns the conservation or the exeresis of the gastric antrum. In     fact, the conservation of gastric antrum could facilitate the gastric emptying and to     decrease the RGO (main complication) and act on the regulations of hormones modulators of the     insulino-secretion.      A prospective,randomized study comparing these both techniques is necessary to determine a     unique consensual technique   "
132504|NCT01550588|"     Background and hypothesis:      The appropriate treatment strategy for secondary stroke prevention in patients with     cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and     anatomical variables reported to be risk factors associated with stroke recurrence include     older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm     (ASA), which, however, were not confirmed by other studies. The investigators hypothesized     that percutaneous closure of PFO could be an effective option for secondary prevention in     cryptogenic stroke patients with high-risk PFO.      Trial Objective:      The primary objective of this study is to assess whether percutaneous device closure of PFO     is superior to conventional antithrombotic treatment in preventing stroke recurrence in the     cryptogenic stroke patients with high-risk PFO.   "
132505|NCT01550575|"     This study will evaluate deidentified (anonymous) data in subject medical charts to review     the clinical outcomes of spinal cord stimulation.   "
132506|NCT01550562|"     The purpose of this study is to investigate the effects of varying programming parameters in     subthreshold spinal cord stimulation therapy for pain relief.   "
132507|NCT01550549|"     This study will investigate the performance of physician readers trained to read     florbetapir-PET scans using electronic media training.   "
132508|NCT01550536|"     The primary purpose of this study is to expand research on the effects of physical activity     on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the     effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training     program. The investigators will measure BMR by indirect calorimetry and normalize it across     subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups will     be compared: an intervention group (no previous participation in regular exercise, newly     enrolled in this study's 16 week training program), and a long-term athlete group (have     engaged in at least 5 hours of exercise per week for the past 10 years or longer). A     secondary aim is to generate an equation for the prediction of BMR from fat free mass in     physically active postmenopausal women, to be applied to hypotheses in biological     anthropology. The investigators expect to find at baseline that, controlling for fat free     mass and VO2MAX, the long-term group will have significantly higher BMR than the intervention     group. At 16 weeks the investigators expect no change in BMR for the long-term group, while     BMR will have increased in the intervention group. At the same time, the investigators expect     to find that after completing the training regimen, the intervention group will have BMR     similar to that of the long-term athletes.   "
132509|NCT01550523|"     This human Phase I trial involves taking the patient's own tumor cells during surgical     craniotomy, treating them with an investigational new drug (an antisense molecule) designed     to shut down a targeted surface receptor protein, and re-implanting the cells, now     encapsulated in small diffusion chambers the size of a dime in the patient's abdomen within     24 hours after the surgery. Loss of the surface receptor causes the tumor cells to die in a     process called apoptosis. As the tumor cells die, they release small particles called     exosomes, each full of tumor antigens. It is believed that these exosomes as well as the     presence of the antisense molecule work together to activate the immune system against the     tumor as they slowly diffuse out of the chamber. This combination product therefore serves as     a slow-release antigen depot. Immune cells are immediately available for activation outside     of the chamber because a wound was created to implant these tumor cells and a foreign body     (the chamber) is present in the wound. The wound and the chamber fortify the initial immune     response which eventually leads to the activation of immune system T cells that attack and     eliminate the tumor. By training the immune system to recognize the tumor, the patient is     also protected through immune surveillance from later tumor growth should the tumor recur.     Compared to the other immunotherapy strategies, this treatment marshalls the native immune     system (specifically the antigen presenting cells, or dendritic cells) rather than     engineering the differentiation of these immune cells and re-injecting them. Compared to     traditional treatment alternatives for tumor recurrence, including a boost of further     radiation and more chemotherapy, this treatment represents potentially greater benefit with     fewer risks.      This combination product serves as a therapeutic vaccine with an acceptable safety profile,     which activates an anti-tumor adaptive immune response resulting in radiographic tumor     regression.   "
132510|NCT01550510|"     This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment     with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced     colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy.     This study will be conducted as an amendment to Investigational New Drug # 77486.   "
132511|NCT01550497|"     1. Do spinal stabilization exercises demonstrate immediate and long-term effects of weight          weeks of spinal stabilization exercises as measured by pain intensity and quality of          life scores?        2. Does eight weeks of spinal stabilization exercises improve back muscle endurance in          adolescents with Idiopathic Scoliosis (IS) with low back pain (LBP), compared to a          one-time treatment (control)?      Hypotheses:      The research hypothesis for Question 1 is: Participants who receive eight weeks of spinal     stabilization exercises will demonstrate significantly improved pain intensity and quality of     life scores compared to participants who receive a one-time treatment after eight weeks of     the intervention period and at six-month follow-up.      The research hypothesis for Question 2 is: Participants who receive eight weeks of the spinal     stabilization exercises will demonstrate significantly improved back muscle endurance,     compared to participants who receive a one-time treatment after eight weeks of intervention.   "
132512|NCT01550484|"     The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to     differentiate subjects with Parkinson's Disease from other movement disorders.   "
132513|NCT01550471|"     This study will provide the clinicians guidance on the safest combination of inhaled and     nasal corticosteroids for children with mild asthma and allergic rhinitis respectively;     however, one safety concern is that these products are independently known to have     dose-related effects on short term and intermediate term growth. Knemometry is a non invasive     technique for measuring short-term lower leg growth in children and is currently the method     of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18     weeks and at each visit, lower leg length will be measured using knemometry.   "
132514|NCT01550458|"     The objective of the study is to determine the safety and pharmacokinetics of a 7 day course     of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation     study in which the total daily dose of mibefradil will be increased with each cohort.   "
132515|NCT01550445|"     The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3     months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and     basiliximab. This study is an open-label, prospective, controlled clinical trial in a single     center. Those patients who fulfill the entry criteria could enter in this prospective     controlled trial of steroid withdrawal three months after transplantation.   "
132516|NCT01550432|"     The rationale for the potential role of antioxidants in the prevention of cardiovascular     diseases (CVD) remains strong despite the disappointing results of recent trials with a few     select antioxidant vitamins. Glutathione (GSH) is one of the body's most powerful antioxidant     agents but there is a surprising paucity of data on its use as an interventional therapy.      Glutathione, when taken orally, is immediately broken down into its constituent amino acids,     of which cysteine is the only one to be essential. Available cysteine is the critical     determinant of intracellular GSH concentrations. N-acetyl cysteine (NAC) is an antioxidant     supplement that has been used to provide a source of cysteine to replete GSH levels. By     replenishing endogenous glutathione, it is possible that NAC would exert the same effect(s)     as exogenous GSH.      However, there is a new delivery system, liposomal GSH, which keeps glutathione intact. In     this study, the investigators propose to match the cysteine content of NAC and GSH and     compare the effects of these two supplements, at two different doses, on markers of     inflammation and oxidative stress.   "
132674|NCT01548365|"     The purpose of this study is to determine whether an infusion therapy nursing expert service     is effective in decreasing hospital length of stay, improving the clinical results of venous     access devices and increasing patient satisfaction with venous access.   "
132530|NCT01550250|"     Women who have undergone breast cancer surgery may develop swelling of the arm on the side     the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This     study will examine night-time compression system garments for lymphedema. Our objective is to     determine if breast cancer survivors are willing and able to use the garment overnight to     help control their lymphedema. Thirty breast cancer survivors from Alberta will be enrolled     in the 24-week long study. Measurements will be taken of each arm to assess the extent of     lymphedema and to measure changes over the study period. We will also examine other outcomes     such as the impact of the night-time compression system garment on sleep. The study will     provide important information on the feasibility of night-time compression system garments as     a self-management strategy for lymphedema.   "
132873|NCT01545739|"     The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac     resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and     efficacy of these pacemakers. In particular, the left ventricular (LV) capture control     feature is evaluated, which automatically measures the LV pacing threshold and subsequently     adjusts the pacing output.   "
132874|NCT01545726|"     This study will assess the safety and efficacy of QAW039 when added to current therapy in     patients that have sputum eosinophilia and persistent asthma.   "
132517|NCT01550419|"     Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in     ventilated critically ill patients specially in intensive care unit (ICU). It is associated     with an increased duration of mechanical ventilation, high death rates and increased     healthcare costs in China. However, VAP is preventable and many practices have been     demonstrated to reduce the incidence of this disease, but the morbidity is still so high. So     much more methods of prevention should be needed to reduce the incidence of VAP.      Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) present     anti-inflammatory and immunomodulatory effects besides their ability to regulate cholesterol     composition. So it is hypothesized that early use of statin may prevent some of the infection     disease such as VAP.      Actually, Two studies have showed that statin treatment is associated with reduced risk of     pneumonia. However, the relationship between statins and reduced risk of pneumonia is not     consistent.      After reviewing some of the guidelines,meta analyses and system reviews, the investigator     find that advanced age,immune suppression from disease or medication and specially depressed     level of consciousness are the risk factors of VAP. So the investigator assumes that early     use of statin may give us a favorable outcome in the patients with coma or in the patients     with severe disease (Acute Physiology and Chronic Health Evaluation II score > 15 or Glasgow     coma score < 7).      In addition there is no prospective study to investigate the role of statins in VAP in the     patients with ischemic stroke. The investigator hopes that this study can approve the     relationship between statins and reduced risk of VAP in the patients with ischemic stroke.     And it can improve the processes,outcomes and costs of critical care as well.   "
132518|NCT01550406|"     To date, there has been many methods suggested to reduce pancreatic fistula. But there are no     evidence of superiority to the other methods. This study is a multicenter prospective     randomized phase III study of use of Tachocomb or Polyethylene Glycolic Acid (PGA) to prevent     of pancreatic fistula after distal pancreatectomy.   "
132519|NCT01550393|"     RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help     doctors identify biomarkers related to cancer.      PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.   "
132520|NCT01550380|"     This is a phase II open label fixed dose study in subjects with advanced, metastatic, or     refractory endometrial or ovarian, fallopian tube, or primary peritoneal cancer with PI3     kinase pathway activation as demonstrated by PIK3CA gene mutation, PTEN gene mutation, or     PTEN null/low protein expression.   "
132521|NCT01550367|"     The main goal of the research study is to determine whether treating renal cell cancer     patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of     kidney cancer that has spread to other parts of the body, can make the cancer easier to kill     and eliminate. Another goal is to see how the study drug affects the body's immune cells     which fight cancer cells.   "
132522|NCT01550354|"     Several methods have been demonstrated to improve intubating conditions during sevoflurane     induction in children. These include opioids, propofol, and addition of neuromuscular     blocking agents in pediatric patients. But the study about the comparison of these agents has     been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short procedure     performed under general anesthesia. The investigators aimed to compare intubating conditions     among children with propofol, alfentanil or rocuronium after sevoflurane induction.   "
132523|NCT01550341|"     As of July, 2014 the study aims have changed. The revised project, called STRIDE2, is a     longitudinal, non-randomized, observational study of individuals living with HIV who are     dependent on opioids. This study is funded by the National Institute on Drug Abuse     (R01DA030768, Altice, PI; Taxman & Lawson, Co-PIs) and is being conducted by George Mason     University, Yale University, and Howard University. Those individuals originally enrolled in     the STRIDE RCT will be followed for 12 months.   "
132524|NCT01550328|"     The primary objective is to identify device characteristics, components or subsystems that     manifest as screening score bias in SCOUT DS.   "
132525|NCT01550315|"     The investigators will test the hypothesis that markers of vascular endothelial dysfunction     will be exaggerated acutely with an extreme high sodium diet compared to an extreme     low-sodium diet. The investigators will compare patients with postural orthostatic     tachycardia (POTS) to healthy control subjects.   "
132526|NCT01550302|"     The investigators want to know whether injecting numbing medication on the side of the neck     (also called superficial cervical plexus block) can prevent or reduce shoulder pain that     patients commonly experience after lung surgery. The investigators will perform the injection     at the end of your surgery while the subjects are still under general anesthesia and before     they wake up. The investigators will use a local anesthetic (bupivacaine or Marcaine®) that     is routinely used for skin infiltration of the surgical wounds.      This study is randomized and single-blind. This means that subjects will be assigned by     chance (like flipping a coin) to receive either an injection with active medication     (bupivacaine), or no injection at all.   "
132527|NCT01550289|"     The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine     in India adult subjects.      Primary Objectives:        -  To describe the neutralizing antibody response to each dengue virus serotype before the          first vaccination and after each vaccination with CYD dengue vaccine in all subjects.        -  To describe the safety of the CYD dengue vaccine after each dose in all subjects.      Secondary Objective:        -  To detect symptomatic dengue cases occurring at any time in the trial.   "
132528|NCT01550276|"     Background. Headache is one of the most common causes of consultation in primary health care     and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion     at the suboccipital level, facilitating the referred head pain.      Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type     headache.      Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and     a follow-up at one month post-treatment. Eighty-four patients with tension-type headache were     assigned to 4 groups (3 treatment groups and 1 control group). Treatments included manual     therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a     combination of both techniques. Outcome measures were: impact of headache, disability caused     by headache, ranges of motion of the craniocervical junction, frequency and intensity of     headache, and associated headache symptoms.      Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01),     disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue     inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and     craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and     in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and     intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated     headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to     large.      Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective than     suboccipital soft tissue inhibition for tension-type headache. The treatment with     suboccipital soft tissue inhibition, despite producing less significant results, also has     positive effects on different aspects of headache.   "
132531|NCT01550237|"     The clinical importance of cone beam computer tomography based image guided radiotherapy (CT-     IGRT) has not been established. The primary aim of the present trial is to investigate     whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from     curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning     target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as     secondary outcome.      An open randomised phase III trial. The included men will be randomised to receive curative     radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and     standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position     verification and reduced safety margins (7mm).   "
132532|NCT01550224|"     The purpose of the study is to first determine if Temozolomide plus Vorinostat in combination     can control relapsed or refractory AML and determine if this combination can be safely taken.     The study will look at the side effects of the Temozolomide plus Vorinostat in combination     and whether the treatment schedule is tolerated.   "
132533|NCT01550211|"     This study aims to identify electrophysiological correlates of impaired perceptual and     linguistic processes in chronic schizophrenic patients, un-medicated first-episode     schizophrenic patients and their healthy relatives.      Following administrating some questionnaires (demographic details and psychiatric history     questionnaire, handedness questionnaire, reading abilities test and positive and negative     symptoms questionnaire) and performing a perception test and a verbal abstract intelligence     test, participants will conduct a brain scan during a series of perceptual and linguistic     tasks.   "
132534|NCT01550198|"     The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring     results in an earlier detection of circulatory failure in newborn infants   "
132535|NCT01550185|"     The purpose of this study is to find out the highest safe dose and examine the side effects     and effectiveness of eltrombopag olamine in patients with acute myeloid leukemia (AML)     treated with chemotherapy that have not responded to previous therapy or have suffered a     relapse   "
132536|NCT01550172|"     The purpose of the study is to determine whether a combined intervention of a night home     monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in     improving sleep in dementia caregivers who arise at night.   "
132537|NCT01550159|"     This study aims to evaluate the possible Correlation Between Serum Levels of Markers of     Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery.   "
132538|NCT01550146|"     Fracture neck of femur is a common cause of hospital admission in the elderly and requires     operative fixation.      Dexamethasone has the potential of inhibiting cortisol secretion. In addition, preoperative     glucocorticoids improve analgesia and decrease opioid consumption with reduction in     associated side effects in a variety of clinical settings.      The investigators hypothesis was that a single dose of preoperative dexamethasone enhance     postoperative analgesia and attenuates the inflammatory response in patients undergoing     operative fixation of fractured neck of femur, in a prospective, randomized, placebo     controled trial.   "
132539|NCT01550133|"     This study has two main aims: 1) To determine if ingestion of solid or beverage food forms     will change appetite hormone responses, and 2) To determine whether learning (defined as 2     week daily consumption) about the metabolic consequence of ingesting solid or beverage foods     forms varying in energy alters appetite hormone responses.      Beverage consumption has been implicated in the problem of obesity. However, the exact     relationship between beverages, lower appetitive response and lower compensatory dietary     responses remains unclear. This study aims to address this gap in the research. For aim 1,     the null hypothesis is that the energy in beverage and solid forms will not affect appetite     hormonal responses differently. The alternative hypothesis is that exposure to the     energy-yielding beverage will elicit a lower appetitive hormone response compared to oral     exposure to the solid food form. For aim 2, the null hypothesis is that learning will not     change appetite hormone responses. The alternative hypothesis is that learning will decrease     appetite hormone responses in the non-energy-yielding beverage more than in the     energy-yielding beverage.   "
132540|NCT01550120|"     This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds     change with repeated testing. Threshold testing for NEFA taste has been reported by a number     of laboratories, including our own; however, these studies have reported data for only one     testing occasion. The investigators seek to conduct repeated testing to measure the     test-retest reliability of these methods. The investigators believe that with repeated     exposure to NEFA, a person's sensitivity increases. The investigators are also testing the     efficiency of testing by two methods (forced-choice ascending trial versus staircase).     Additionally, the association between taste responses, diet and BMI will be explored.   "
132590|NCT01549457|"     This study will examine the impact of use of mobile phones and text messaging on adherence to     treatment for patients with latent TB infection. Half (50%) of the 350 anticipated study     participants will receive weekly text messages inquiring on their health status in relation     to their prescribed treatment, while the other half (50%) will not receive weekly text     messages at all. Medical adherence will be assessed by monthly blood-work, clinic visits and     by interviewing patients at each of these visits.      The investigators hypothesis is that enhanced communication with a health care provider, via     a structured cell phone SMS text messaging based program (WelTel), will result in a 15%     improvement in the proportion of patients who successfully complete their LTBI treatment     regimens.   "
132591|NCT01549444|"     The purpose of this study is to find out if mothers with high blood pressure (Hypertension)     and/or diabetes have babies with high levels of different substances (that help to regulate     blood pressure, called Renin and Aldosterone) in their blood. The investigators are also     trying to determine if these babies have higher blood pressure than those babies born to     mothers without high blood pressure or diabetes, during the first year of life.      The investigators will measure your baby's blood pressure once a day for the first 4 days, at     1 week of age, and then once per week until your baby is discharged. The investigators will     also measure the blood pressure after discharge at 4 and 10 months of age, either on the day     of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our     Outpatient Nephrology Clinic, both at CHEO.   "
132541|NCT01550107|"     Sarcopenia is defined as the presence of low muscle mass and either decreased muscle strength     or function. It is increasingly becoming a significant cause of frailty, loss of independence     and physical disability in ageing western populations. Recent experimental evidence has     revealed that skeletal muscle is particularly susceptible to damaging molecules that result     in oxidative stress and that oxidative stress plays a prominent role in the development and     progression of sarcopenia. The investigators have previously shown that the xanthine oxidase     inhibitor allopurinol is able to abolish vascular oxidative stress and improve endothelial     function in cohorts such as optimally treated chronic heart failure and chronic kidney     disease. Recently, the investigators have also shown that allopurinol improves exercise     tolerance and time to ST-depression in optimally treated coronary artery disease, suggesting     that allopurinol could also exert its effects through ATP and/or oxygen sparing mechanisms.      Therefore, we propose a randomised double blind placebo-controlled parallel group trial of     allopurinol in patients with primary sarcopenia using MR-spectroscopy and Flow Mediated     Dilatation to investigate the possible mechanisms that underlie this exciting possibility   "
132542|NCT01550094|"     One technique for the nerve block involves injecting the numbing medicine where the nerve is     together (higher up in the back of the thigh). The other technique involves injecting the     numbing medicine where the nerve splits into two parts. By injecting numbing medication     around the nerve(s), there will be less pain after the procedure. It is thought that the     numbing medicine will be easier to inject in the group that the nerves are split. It is     expected that subjects may need less pain medication and have lower pain ratings in this     group too.   "
132543|NCT01550081|"     Aerobic interval training is shown to be superior in increasing oxygen uptake in both healthy     and patients with coronary artery disease (CAD), compared to moderate continuous training.     However, in cardiac rehabilitation exercise groups, exercise intensity is usually controlled     with perceived exertion (Borg scale). The investigators will investigate degree of agreement     between target heart rate and perceived exertion during interval training in cardiac     rehabilitation.   "
132544|NCT01550068|"     Acute rheumatic Fever (ARF) results from an autoimmune response due to molecular mimicry     between the M-protein on the group A β-hemolytic streptococci (GABHS) cell membrane and     cardiac myosin, and may lead through recurrent or sustained inflammation to Rheumatic Heart     Disease (RHD). RHD remains a major contributor to morbidity and premature death in the     working age population in Nepal. Secondary prevention with regular oral or intravenous     administration of penicillin continued until early adulthood is recommended to prevent the     progression of the development of endocarditis and subsequent valvular dysfunction.      Screening for rheumatic heart disease using echocardiography has the potential to detect     rheumatic valvular lesions at an earlier, clinically silent stage, as compared to clinical     examination alone and might have a beneficial impact on long-term outcome of children with     RHD. Schoolchildren aged 5-15 years from several public and private schools from rural and     urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography.      Three main inter-related objectives will be pursued in three phases of the study: In a first     phase using a cross sectional approach, the prevalence of clinical and subclinical RHD will     be investigated among a representative sample of schoolchildren from public and private     schools in urban and rural areas. In a second phase, using a cohort study approach among     those children diagnosed at different stages of RHD, clinical outcomes with regular medical     surveillance will be assessed (a), and clinical and social risk factors associated with     prognosis of the disease after receiving medical care at various stages of disease at     diagnosis will be determined (b). A third phase will integrate the prevalence rates from     phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact     of screening and RHD treatment on health resource utilization.   "
132545|NCT01550055|"     The primary purpose of this study is to evaluate the clinical response and safety of     cetuximab plus irinotecan synchronously/subsequently in patients with KRAS wild-type     metastatic colorectal cancer   "
132546|NCT01550042|"     Recent studies demonstrated that prolonged rhythm observation increases the detection of     atrial fibrillation in patients prior diagnosed as cryptogenic stroke. Detection of atrial     fibrillation in these patients has important therapeutic implications for the anticoagulation     regimen. However, data on optimal monitoring duration and method of AF detection are limited.   "
132547|NCT01550029|"     The purpose of this research is to develop and test a new type of smoking cessation     counseling for individuals with bipolar disorder.   "
132548|NCT01550016|"     Improvements in diagnosis of dengue fever and prediction of which patients will get more     severe disease are urgently needed to improve the treatment of patients with dengue. This is     very important in places with many people who suffer from dengue but have limited health care     resources. This study will enroll patients with fever which may be caused by dengue in 6     countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador,     Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests     and exams until they recover. Symptoms and laboratory tests will be followed so that the     cause of fever can be determined. For patients who have dengue, the investigators will look     for symptoms and tests which indicate more serious disease. This study will help to determine     how to identify patients with dengue fever based on symptoms and simple laboratory tests and     those who will get more serious disease. It will also help to define a more standardized     management of patients with dengue fever.   "
132549|NCT01550003|"     A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of     Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active     Polyarticular-course Juvenile Idiopathic Arthritis (JIA).   "
132563|NCT01549808|"     Abstract Many patients experience serious reduced functional ability after a critical illness     and hospitalization in an Intensive Care Unit. The cause of the reduced functional ability is     the combination of critical illness and immobilization following treatment with a ventilator.     The functional ability of patients can be affected up till a year after the discharge, and     may shows a decrease in ability to walk and in problems with focusing.      Studies show that it is safe and possible to mobilize the patients with for instance bed     bikes, sitting up and standing up, even during ventilator therapy. The effect is shown as     lesser days with delirium, on a ventilator therapy or hospitalization. No study has shown how     early and at which intensity a patient can be mobilized. Our hypothesis is that an early     systematic mobilization improves functional ability of the critically ill patient, mentally,     physically and their life expectancy. The purpose of this study is to evaluate a mobilization     protocol applied at critically ill patients, including a contribute related to knowledge of     how soon and how intense patients ventilated for more than 48 hours can endure mobilization.     To evaluate the connections between functional ability and life expectancy for critically ill     patients are compared to a population matching in age.      This intervention project has a multicenter design with pre- and post research related to     effect in early systematic mobilization of critically ill patients. 200 patients are included     in the project.      Data are collected at tests showing the functional ability of patients in different ways. The     tests are made at the discharge from the Intensive Care Unit and 5 days after at their wards     and again at 3 and 12 month from discharge when the patients have returned to their home. The     project started in February 2011 and is expected to end in May 2013, findings is expected in     November 2013.   "
134606|NCT01522937|"     This is a Phase II trial to characterize the safety and efficacy of individualized     stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment     or who have primary hepatocellular carcinoma (HCC).   "
132550|NCT01549990|"     Living-donor kidney transplantation has been considered as the best treatment for patients     with end-stage renal disease (ESRD). Kidney donation from living donors has been performed     widely under their noble humanity and a belief that donation would not harm the donor.     Although the overall evidences proposed that living kidney donor have medical outcomes     similar to those in general population, several reports have demonstrated the potential risks     for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be     concentrated on ensuring their safety and preserving the function of their remained kidney     during anesthesia maintenance.      Inhaled anesthetics have been frequently used for the induction and maintenance of general     anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride,     which may be directly nephrotoxic through impairments of renal concentrating ability. The     typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The     defluorination of sevoflurane can results in increased serum inorganic fluoride ion     concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human.     On the other hand, desflurane is extremely resistant to defluorination, and desflurane does     not appear to be nephrotoxic.      The inhaled anesthetics which are currently used in general anesthesia have no clinical     evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially in     the patients who one kidney is donated. The purpose of the current retrospective, single     center study was to evaluate and compare postoperative renal function of living kidney donor     after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based     recommendations of proper inhaled anesthetics for anesthesia of living kidney donor.   "
132551|NCT01549977|"     The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared     to placebo as an add on to stable anti-anginal therapy, on the total exercise time of     participants with Chronic Stable Angina.   "
132552|NCT01549964|"     The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50     mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus     metformin on lowering blood sugar.   "
132553|NCT01549951|"     The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to     investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with     Metastatic Castration-Resistant Prostrate Cancer   "
132554|NCT01549938|"     This is a feasibility double-blind randomised controlled trial in 32 participants. It     evaluates the feasibility of a full trial which will examine the efficacy of weekly     supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent     frequency and severity of objectively-verified symptomatic acute respiratory tract infection,     overall and as a proportion of detected colonisations of the upper respiratory tract by 9 of     the most common aetiologic viral pathogens.   "
132555|NCT01549925|"     The objective of this prospective randomized surgical trial is to evaluate whether the use of     the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with     ovarian cancer will reduce the surgical time compared to standard surgical resection using     clamps and surgical ligatures.   "
132556|NCT01549912|"     The primary objective of this research is to examine the result of rotator cuff repairs     following acute shoulder dislocations and to investigate whether timing of surgery following     acute shoulder dislocations affects patients perception of pain, function, and strength     following surgery.   "
132557|NCT01549899|"     The objective of this study is to directly compare 6 sessions of in-person and Internet     administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control     (MC), within an active duty military population to determine the comparative benefits of     these interventions on improvement in sleep as well as domains strongly related to insomnia     such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel     with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions     (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The     investigators will compare these three groups on subjective and objective measures of sleep.     The CBTi and MC control groups will be compared on other variables of interest (e.g.,     depression, substance abuse, and PTSD symptoms) and predictors of outcomes.   "
132558|NCT01549886|"     The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen     compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade     or follicular NHL.      Effectiveness of the experimental regimen will be assessed by complete response rate within 6     months of study entry (primary endpoint), complete response rate within 3 months of study     entry, and overall response rate within 6 month of study entry.   "
132559|NCT01549873|"     When patients have spinal surgery, electrodes are placed on the body to measure motor evoked     potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV     anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At     this hospital the investigators typically use inhaled anesthesia and are able to successfully     measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than     the other for measuring MEP and SSEP.   "
132560|NCT01549860|"     This trial is a prospective, randomized, controlled, multi-center study of subjects     presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and     effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care     (SOC) alone in the treatment of lower extremity venous ulcers.   "
132561|NCT01549847|"     This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue     and muscle pain in patients with Postpoliomyelitis Syndrome.   "
132562|NCT01549834|"     This is an efficacy and safety study evaluating a new treatment for subjects with mild to     moderate Alzheimer's disease.   "
132584|NCT01549535|"     The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light     source and other ancillary equipment. The system is intended for endoscopic diagnosis,     treatment and video observation of the digestive tract. The PeerScope system model B is     indicated for use for endoscopy and endoscopic treatment within the lower digestive tract     (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.      Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™     extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.      In addition, time measurements including time to cecum, time for withdrawal and overall     procedure time will be analyzed and reported for each group.   "
132564|NCT01549795|"     Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be     subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.      Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent     in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing     this type of neoplasm. Only a minority of patients are suitable for resection partly because     of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and     partly because of the frequently coexisting liver disease. In fact, CC is currently     considered a major contraindication to liver transplantation (OLT) at the majority of     centers, given a 5-year survival rate of 0%-35%.      New strategies have been developed for the treatment of this kind of cancer arising in PSC.     The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a     neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver     transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver     transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5     years survival. More convincing results come from the Mayo Clinic. An accurate selection of     patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and     intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver     transplantation.   "
132565|NCT01549782|"     Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal     biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface     epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal     inflammation. Modifications in intestinal microbiota, such as an increase in the number of     pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is     assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium,     Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).      The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could     modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients     affected of gynaecological cancer and treated with abdominal radiotherapy.   "
132566|NCT01549769|"     This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in     patients with chronic kidney disease and type 2 diabetes.   "
132567|NCT01549756|"     Find A Cure Panel is looking for people with Stage 4 stomach/gastric cancer or the caregivers     of people with Stage 4 stomach/gastric cancer to participate in anonymous and qualitative     research that will take an estimated 60 minutes of your time.      This is opinion based, experiential research and is NOT a drug trial.      Note that Stage IV is also known as advance disease or metastatic stomach/gastric cancer.      If you are interested in participating, please email FACP at: info@findacurepanel.com   "
132568|NCT01549743|"     This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and     rebamipide in healthy male subjects.   "
132569|NCT01549730|"     The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer     using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have     an effect on how cervix cancer grows and responds to treatments like radiotherapy and     chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300     patients. The use of PET scans to measure hypoxia may be better and simpler than the methods     used previously.   "
132570|NCT01549717|"     The investigators plan to study patients who have had cardiac surgery. Current standard     practice is to monitor patients who have had cardiac surgery using wall-mounted monitors     whilst they are on the Overnight Intensive Recovery (OIR) and the cardiac High Dependency     Unit (HDU). The wall-mounted monitors monitor the vital signs continuously and alert the     nurses if any abnormalities are detected. Once a patient is transferred from HDU to the     cardiac surgery ward for the most part they are no longer connected to a continuous monitor.     Instead, the majority of patients on the ward have their vital signs only intermittently     checked during the day, using a spot check monitor. There is a small minority, chosen on     clinical grounds, who are assessed with wireless telemetry monitors for a day or two.      In this study the investigators will continuously monitor the vital signs of all enrolled     patients from the time that they leave the operating theatre to the the time they are     discharged from hospital. Whilst they are on OIR and HDU they will be monitored with the     standard wall-mounted monitors in the normal fashion. When they then move to the ward the     investigators will give all enrolled patients a telemetry monitor to wear as well as asking     the nurses to check their vital signs with spot check monitors.      The investigators will also collect information about the patients' general state of health     and record indicators of worsening in patients' condition so that the investigators can     determine how changes in the vital signs relate to deterioration. Finally the investigators     plan to survey the patients and nurses to understand their experiences of continuous     monitoring and what needs to be changed to improve the patient experience.   "
132571|NCT01549704|"     The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior     to placebo when it comes to analgetic efficacy in high pain responders after Total Knee     Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during     knee flexion the 1. or 2. day after surgery.   "
132572|NCT01549691|"     The purpose of this study is to test the level of anxiety in patients, the day before surgery     (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.        -  one receiving placebo before going to sleep (before sleep), the day prior surgery and          placebo when awakening (awakening), the day of surgery        -  one receiving zopiclone (7.5 mg) before sleep and placebo at awakening        -  one receiving placebo before sleep and alprazolam (0.5 mg)at awakening      double blind, randomized controlled study   "
132573|NCT01549678|"     The hypothesis to be tested is that the use of total contact insoles for six months reduces     foot pain, improves function and quality of life of patients diagnosed with plantar     fasciitis.   "
132585|NCT01549522|"     This is opinion based, experiential research and is NOT a drug trial.   "
132586|NCT01549509|"     The RV 156A clinical trial is evaluating an experimental HIV vaccine in people who are not     infected with HIV. Participants in that study are randomly assigned to receive either the HIV     vaccine or placebo. This study will enroll people who are participating in the RV 156 study.     In this study, researchers will evaluate the safety of and immune response to a different     experimental HIV vaccine in people who participated in the RV 156 study.   "
132574|NCT01549665|"     Graft-versus-host-disease (GVHD) is a major complication following allogeneic hematopoietic     stem cell transplantation (allo-HSCT) which may cause acute life-threatening morbidity or     chronic disabilities. Although corticosteroid, the primary agent to treat GVHD, may be     effective for some patients, outcomes of those who are refractory to corticosteroid are     dismal. Secondary agents can be used for steroid-refractory cases; however, their efficacy is     variable and usually limited. The quality of life issue of chronic GVHD is especially     important for pediatric survivors who have longer life expectancy than adults. Many in-vitro     and in-vivo data support immunoregulatory properties of mesenchymal stem cells(MSCs)and     possibilities of treating diseases caused by immune dysregulation such as GVHD. Recent data     revealed that bone marrow-derived MSCs were very useful to treat steroid-refractory acute     GVHD, which led to improved overall survival compared with controls. More recently, a number     of reports suggest MSCs may also be useful in treating chronic GVHD as well as acute GVHD. It     has been also reported that third party MSCs are also useful as well as those from autologous     or HLA-matched donors. The investigator recently demonstrated that MSCs obtained from     umbilical cord blood (UCB) have similar immunosuppressive properties as bone marrow-MSCs.     UCB-MSCs can be obtained without doing any harm to donors that it may be more appropriate     source of MSCs than bone marrow for off-the-shelf use. However, little is known about the     safety and efficacy of UCB-MSCs in treating GVHD. Therefore, the investigator designed this     study to evaluate the safety and efficacy of UCB-MSCs in treating pediatric patients with     steroid-refractory acute or chronic GVHD.   "
132575|NCT01549652|"     Opioid medications are commonly used for pain relief. When given over time, physical     dependence can occur. This results in unpleasant side effects--such as agitation and     nausea--if opioid medications are suddenly stopped. This study aims to test the use of the     drug ondansetron to reduce the symptoms associated with opioid withdrawal and to prevent the     progression of opioid physical dependence, thereby allowing future investigators to better     test the role of physical dependence in the development of addiction and also possibly     improving acceptance of abstinence-based programs for addiction.   "
132576|NCT01549639|"     Propofol is a commonly used agent for sedation and anaesthesia in the intensive care unit and     the operating room. The pharmacokinetics of propofol are difficult to predict in patients not     conforming to the norms in which the original pharmacokinetic research was based. Such     patients, including the critically ill, and morbidly obese, are increasingly being     encountered. The investigators group have been involved in the development of a device which     can measure blood propofol concentrations, and hope for this to be available to use in the     operating room in a clinically useful timeframe in the future. Data will be collected on     patients undergoing propofol based general anaesthesia. The Marsh target controlled algorithm     in effect site mode (commonly used by anaesthetists) will be assessed for accuracy using the     propofol monitor. A new proportional correction method will be developed using this data,     designed to enable recalibration of the TCI algorithm in near real time in order to achieve a     more accurate estimated propofol concentration in these identified patient groups. The     research will investigate the effectiveness of a correction of estimated propofol levels     based on a one off measurement early on in the anaesthetic, and will take subsequent samples     to measure propofol levels without modifying the TCI algorithm. Additionally, data on     anaesthetist choice of TCI model, and method of administration in this relatively unselected     group of patients will be analysed.   "
132577|NCT01549626|"     Inclusion of foods rich in fiber, such as flaxseed, is a nutritional strategy for treating     obesity. The hypothesis of this study is to compare the effects of three types of flaxseed     flour - whole brown flaxseed flour, brown defatted flaxseed flour and golden flaxseed flour     in the sensations of appetite and satiety, lipid profile, pressure levels and associated     costs in overweight and obese women.   "
132578|NCT01549613|"     This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the     Emergency Department (ED) treatment of complicated skin and skin structure infection in the     Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who     are admitted to the RDTC cellulitis protocol in the ED will be randomized to either     vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or     daptomycin, which is the experimental treatment in this study. The primary hypothesis is that     daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.   "
132579|NCT01549600|"     The Purpose of this study is to compare the effects of 2 types of dietary fiber, psyllium and     microcrystalline cellulose (MCC), on glycemic measures in subjects with impaired fasting     glucose.   "
132580|NCT01549587|"     This study will track changes in oral health in pregnant women. Subjects will be assigned to     either regular oral care or advanced oral care and be given oral care products to use until     they deliver. A comparison between the two groups (regular and advanced oral care) will be     made to see if the oral care products impacted oral health and maternity variables.   "
132581|NCT01549574|"     This is an open-label, randomized, cross-over, single dose study in healthy volunteers to     evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the     pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of     crioztinib with or without esomeprazole separated by a washout period of at least 14 days.   "
132582|NCT01549561|"     The primary goal of this study is to test the efficacy of two levels of the KEEP intervention     with adolescents and their foster and kin parents in the San Diego Child Welfare System.   "
132583|NCT01549548|"     The main purpose of this protocol is to provide expanded access to the study drug     (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib-     resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of     this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that     have not responded to prior treatment.   "
132587|NCT01549496|"     The purpose of this study is to evaluate the pharmacokinetic interactions between the     hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and     diltiazem in healthy volunteers.   "
132588|NCT01549483|"     The purpose of this study is to study differences in small airways (<2mm) parameters in     asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.   "
132589|NCT01549470|"     Currently, no vaccine prevents HIV infection. This study will test the safety and immune     responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.   "
132592|NCT01549431|"     The purpose of this study is to find out what effects, good and/or bad, the combination of     panobinostat and carfilzomib have on the patient's cancer. It will determine the side effects     of different dose levels of panobinostat and carfilzomib and determine the best dose and     schedule of the two drugs to recommend for future studies. The study will assess the effects     of the drug on multiple myeloma. In addition, tests to study the way the drugs work will also     be done.      The combination of the 2 drug classes have shown both pre-clinical (studies done in the lab)     and clinical (studies done with people) effects against multiple myeloma. For this reason,     these 2 drugs are being studied in combination to determine the side effects and anti-myeloma     effects of the 2 drugs.   "
132593|NCT01549418|"     The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin     is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to     compare the risk of significant bleeding after endoscopic polypectomy of large (>=10mm)     colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA)     use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily     ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the     study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are     composite cardiovascular events occurring between the date of randomization and 30 days after     polypectomy.   "
132594|NCT01549405|"     Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of     patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy     tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib     level would alleviate postoperative pain and reduce analgesic consumption.   "
132595|NCT01549392|"     This study aims to assess the effect of Avastin on brain vascularity and blood-brain     permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications     have documented the method by which DECT can determine alterations in vascular volume and     tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood     flow cerebral blood volume and permeability-surface area can be generated from the DECT     studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour     versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT     imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive     Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be     studied with DECT and MRI spectroscopy at baseline and then again in 3 months.   "
132596|NCT01549379|"     For patients undergoing treatment for head and neck cancer, this study will use dynamic     contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer     and require surgical removal.   "
132597|NCT01549366|"     The purpose of this clinical investigation is to evaluate the Aspen™ device compared to     pedicle screw instrumentation for posterior fixation in the treatment of patients with     degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to     pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of     fusion.   "
132598|NCT01549353|"     Gum chewing has been reported to stimulate bowel motility after open surgery, such as     cesarean section and other abdominal surgeries. In general, after laparoscopic surgery     problems with reduced bowel motility are not as common as after open surgery. In this study     the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel     motility after gynecologic laparoscopic surgery. Further the investigators study patient     satisfaction and potential side effects of postoperative gum chewing.   "
132599|NCT01549340|"     The purpose of this study is to determine the proportion of participants that initiate     allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion of     participants that persist with their AIT throughout the recommended course.   "
132600|NCT01549327|"     For individuals diagnosed with colorectal cancer, exposure to up-to-date cancer information     and support as well as guidance to access the most appropriate health care services is     crucial for cancer self-management and support. Timely access to high quality cancer     information is suggested to contribute to patient empowerment - defined as the perception of     being better able to manage illness demands. With the advent of the information age,     individuals are increasingly turning to online health information resources. The use of     rigorous web-based tools is found to be an engaging and convenient way to access health     information, while being tailored to people's needs and preferences. The present study seeks     to examine the effects of a recently developed high quality and person-centred web-based     tool, the Oncology Interactive Navigator (OIN) on patients' empowerment as well as document     its cost-effectiveness. Participants newly diagnosed with colorectal cancer will be randomly     assigned to experimental or control groups with the former having unrestricted access to the     OIN for 8 months. Participants in the control group will receive care as usual. Information     on background, medical characteristics, and empowerment will be collected as well as     cost-effectiveness indicators. If producing the desired effects, the OIN could be proposed     for national implementation across Canadian cancer centers. Work is currently underway to add     over 23 types of cancer diagnosis to the OIN.   "
132601|NCT01549314|"     The purpose of this study is to determine whether ivacaftor, a recently FDA-approved CFTR     potentiator, improves bone micro-architecture and strength in patients with cystic fibrosis     with at least one G551D CFTR mutation.   "
132733|NCT01547598|"     This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost     ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination     ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution     0.004%) monotherapy.   "
132645|NCT01548742|"     Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in     serious impairments in interpersonal, occupational and social functioning. Effective     treatments are available for PTSD but they do not work for everyone. Alternative treatments     are needed to help those veterans not helped by currently available treatments. Mindfulness     Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation.     MBSR has been found to be effective in helping people with problems with pain and anxiety.     MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR     with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to     Veterans' health because of the need to develop alternative treatments for veterans with PTSD     who have not responded to currently available treatments.   "
132603|NCT01549288|"     Infantile spasms comprise an infantile epileptic encephalopathy characterized by     hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the     treatment of this disorder remains difficult. The first-line options which include hormonal     therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin are     effective in 60-70% of the patients. Hormonal therapy is considered the best available     treatment. Vigabatrin being expensive and of limited availability is not a feasible option     for most patients in our setting. Also, these are however associated with significant side     effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and     levetiracetam have also been evaluated; however these drugs are less effective than ACTH. The     ketogenic diet (KD) is a high fat, low carbohydrate diet. It has been used for treatment of     intractable childhood epilepsy. The KD has also been shown to be effective for intractable     infantile spasms; often after ACTH and vigabatrin have failed.      The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy     that was designed to be a less restrictive alternative to the traditional ketogenic diet.     This diet is started on an outpatient basis without a fast, allows unlimited protein and fat,     and does not restrict calories or fluids. Preliminary data have shown efficacy in refractory     infantile spasms. This diet is also ideal for resource-constraint settings with paucity of     trained dieticians. Hence this study has been planned to evaluate the efficacy and     tolerability of the modified Atkins diet in children with infantile spasms refractory to     hormonal treatment in a randomized controlled trial.   "
132604|NCT01549275|"     The purposes of this prospective study were to evaluate the successful rate of primary     culture of hepatocellular carcinoma cells and cancer-associated fibroblasts from the residual     specimens in routine fine-needle aspiration of hepatic tumor and the potential application of     this method as an additional tool for personalized treatment of hepatocellular carcinoma     patients.   "
132605|NCT01549262|"     The purpose of this study is to determine whether the multivariable model for embryo     selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by     a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison     with standard incubator and an embryo selection process based exclusively in morphology.   "
132606|NCT01549249|"     The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM)     surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.   "
132607|NCT01549236|"     The purpose of this study is to describe the population pharmacokinetics parameters of     benznidazole in children with acute or early chronic indeterminate form of Chagas Disease.   "
132608|NCT01549223|"     The central objective of this study will be to evaluate a standardized, evidence-based     regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean     delivery      The investigators primary hypothesis is that the proposed uterotonic drug regimen, when     compared to conventional dosing regimen, during elective cesarean delivery will:      1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain     satisfactory uterine tone.      Secondary outcomes to be evaluated will be:        1. Reduce the side effects associated with uterotonic drug use        2. Reduce the time to establishment and maintenance of adequate uterine tone   "
132609|NCT01549210|"     The study aims to identify which characteristics are associated with disability and poor     quality of life in patients suffering from gout. This is a multicentre prospective     observational study carried out in a cohort of Italian patients with gout. Subjects are     randomly selected from a list of patients referred to each participant rheumatology clinic in     the previous 2 years. Clinical evaluations are performed at baseline, at 6 and 12 months;     data are retrieved about sociodemographic variables, life-styles, history of gout,     comorbidities and patterns of treatment. At each visit patients complete questionnaires     assessing disability and health-related quality of life. Preplanned analyses will be     performed to investigate predictors of disability and poor quality of life in these patients.   "
132610|NCT01549197|"     The purpose of the study is to evaluate the quality of the dying process in french ICUs     (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions     and experiences, with a one-year follow-up of bereaved relatives.      Our hypothesis is that perception of the quality of dying may impact on relatives' experience     of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder     (PTSD)).   "
132611|NCT01549184|"     Retrospective study of the safety and efficacy of hydroxychloroquine among patients with     immune Thrombopenia (ITP).   "
132612|NCT01549171|"     Human fallopian tube secretes high concentration of prostacyclin. Fallopian tube is the site     for early embryo development. The effect of prostacyclin on human early embryo development is     waiting to be clarified. The study hypothesis is prostacyclin can enhance early embryo     development.   "
132613|NCT01549158|"     This is a randomized, open-label, blinded-endpoint, crossover, single dose study to compare     the pharmacodynamics of Torasemide-PR 10 mg, Torasemide-IR10 mg and furosemide-IR 40 mg. 30     patients of both sexes with CHF with a maximum imbalance of 60:40% in either direction will     be included in the study. Patients with compensated heart failure, grade II or III as defined     by the European Society of Cardiology, with a duration of ≥ 3 months at the time of inclusion     documented in the patient's record or patients who previously required diuretic therapy.      Principal variable will be the efficiency of sodium excretion that will be assessed as the     ratio between the average drug-induced natriuresis and the average drug recovered in urine     over 24 hours.      The difference between the efficiency of 24 hour sodium excretion following administration of     torasemide PR and furosemide will be formally tested by means of a Students t-test for paired     samples. The test will be two-sided at 5% significance level. Efficiency changes over time     will also be assessed, however will not be subject to formal statistical testing.   "
132614|NCT01549145|"     The objectives of this study are to evaluate the safety and efficacy of applying electrical     stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic     stimulation regimen.   "
132747|NCT01547416|"     The aim of this study was to investigate whether robot assisted laparoscopic radical     prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and     whether combined general/epidural anesthesia could provide better postoperative diaphragmatic     function.   "
134633|NCT01522586|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and     pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.   "
132615|NCT01549132|"     The investigators believe that oxygen saturation measurements in the retina may provide more     information on how well the retina is working and may detect problems in the retina earlier     than the fundus fluorescein angiography (FFA). This may be useful to an ophthalmologist so     that they may identify abnormal areas of the retina and commence or change the treatment so     that they may prevent irreversible blindness.      Most patients with clinically significant macular oedema and/or ischaemic diabetic     retinopathy could have either laser or Intravitreal Anti-VEGF injection treatment provided     they are counseled about the risks. It is known the Anti-VEGF injections reduce oedema and it     is believed that laser treatment of the retina in this condition improves the oxygen supply     to the retina and sometimes reverses the damage. It will be useful to take pictures of these     treated eyes using the Oxymap spectral retinal camera(s) to see whether the investigators can     detect a change in the oxygen saturation in the retina before and after treatment using our     oxygen saturation methods.   "
132616|NCT01549119|"     The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic     vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with     undetectable viral loads.   "
132617|NCT01549106|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the     effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.   "
132618|NCT01549093|"     The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are     more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung     Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is     a more effective way.   "
132619|NCT01549080|"     The primary objectives of this study are to evaluate whether Yisui Shengxue Granules therapy     can increase the hemoglobin level in peripheral blood and alleviate the symptoms, and at the     same time, evaluate its safety in the treatment of Thalassemia with the syndrome of     deficiency of liver-yin and kidney-yin, and asthenia of essence and blood.   "
132620|NCT01549067|"     Collect the real clinical background of advanced colorectal cancer c of China.   "
132621|NCT01549054|"     This is a study in healthy subjects. There are two parts to the study. In the first part of     the study each subject will receive a single 10mg dose of each of the four formulations of     E550. Based on the results from Part 1, an optimal formulation will be selected for further     evaluation in Part 2.   "
132622|NCT01549041|"     The investigators propose to explore: 1. the acceptance by patients of once versus twice     daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing     with asenapine, and 3. the changes in psychopathology associated with these two dosing     strategies, in 30 patients with schizophrenia or schizoaffective disorder.      The investigators hypothesize that patient and staff acceptance will be better with once     daily dosing and that improvements in psychopathology will be similar across once daily and     twice daily dosing   "
132623|NCT01549028|"     Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of     osteoporosis and fractures. Osteoporosis, however, may be equally as disabling as COPD, and     may impair respiratory function even further if the patient experiences vertebral     compressions.      In this study, we will survey the prevalence, correlations and effectiveness of intervention     of osteoporosis in COPD patients.   "
132624|NCT01549015|"     This diagnostic study will be performed to investigate the performance of the urea cycle in     healthy subjects, asymptomatic carriers of Urea Cycle Disorders (UCD) mutations and subjects     with genetically proven urea cycle disorders. The ureagenesis rate will be measured by 13C     incorporation assay, a method for in vivo measurement of urea cycle performance with stable     isotopes.   "
132625|NCT01549002|"     Children can develop abscesses (a collection of pus under their skin) that require a     physician to cut it open to let the pus drain out. This is a painful procedure. Most medical     professionals will use numbing cream and inject numbing medicine into the skin, just like at     the dentist, to help reduce the pain. While this helps minimize the pain of cutting the skin,     it doesn't help the pain associated with draining out the pus.      There are many strategies and medications available to physicians to help decrease the pain     of this procedure. Most of the medications available to treat the pain require the placement     of an intravenous (IV) catheter through the patient's skin, which itself is a painful     procedure. In the investigators emergency department, many patients with abscesses that need     a procedure to drain the pus receive a medicine called morphine through an IV.      Some pain medicines, however, can be sprayed into a patient's nose, and have been shown to be     helpful at reducing the pain of a broken bone or a burn. These medicines do not require the     placement of an IV.      The purpose of this research study is to determine whether a medicine called fentanyl, when     sprayed into the nose of patients aged 4 to 18 years undergoing abscess drainage, is not     worse than IV morphine in decreasing the pain of the procedure.      After the risks and benefits of the study are explained to patients and their parents,     written informed consent will be obtained. Written informed assent will be obtained for     patients older than 8 years of age. Like the flipping of a coin, a computer program will     decide randomly which half of the patients will receive fentanyl nose spray and which half     will receive morphine by IV.      The patients assigned to receive fentanyl nose spray will not have an IV placed. The patients     assigned to receive morphine will have an IV placed. Both groups of patients will have the     abscess drainage procedure done the same way. All patients will be videotaped in order to     score their pain by a trained observer. This score is the main outcome (measurement) in the     study.   "
132626|NCT01548989|"     The main objective of this study is to perform the linguistic validation of a new french     questionnaire in a population of sexually active (or not) patients who have undergone surgery     (or not) for stress urinary incontinence or genital prolapse.   "
132627|NCT01548976|"     The main objective of this study is to perform the linguistic validation of the french     version of the PISQ-R questionnaire in a population of sexually active (or not) patients who     have undergone surgery (or not) for stress urinary incontinence or genital prolapse.   "
132643|NCT01548768|"     For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects     without RA (healthy volunteers) who will function as controls.      For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to     increased RA activity despite their current treatment) will be recruited to continue in the     study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF     inhibitor in addition to their current treatment in an open label protocol for increased     disease activity and in the context of standard of care.      The investigators hypothesize that anti-TNF agents in RA patients without heart disease will     not adversely affect the heart (will not cause a detrimental change in heart structure or its     function).   "
132644|NCT01548755|"     The purpose of this study is to study workload assessment of home monitoring based follow up     for ICD or CRTD implanted patient.   "
132628|NCT01548963|"     It is known that acute stress of organism often leads to hyperglycemia even in nondiabetic     patients. It is also known that pathophysiological mechanisms: enhanced gluconeogenesis,     impaired insulin secretion and decreased insulin sensitivity due to anti-insulin effect of     stress hormones and proinflammatory cytokines, or changes of glucose excretion and renal     tubular resorption.      Many studies proved the negative effects of hyperglycemia to different tissues and organs,     e.g. hearth (increasing size of myocardial necrosis, reducing coronary collateral blood flow,     exaggerating ischemia-reperfusion injury, impairing ischemic preconditioning), vascular     (increased risk of thrombosis, endothelial dysfunction, activation of systemic inflammation     with destabilization of atherosclerotic plaques), kidneys and its association with infectious     complications.      The first Leuven study (published in 2001) demonstrated that hyperglycemia in critical care     patients significantly increases risk of organ complication and total mortality. Although the     importance of postoperative tight glycemia control is now widely accepted, glycemia stability     during cardiac surgery is often neglected. It is known that postoperative hyperglycemia has     negative effects, but it is not known what effect has its peroperative elevation.      Goal of this study is to demonstrate, whether full perioperative intensive glycemia control     can reduce the incidence of postoperative morbidity even more than postoperative glycemia     control only.   "
132629|NCT01548950|"     The purpose of this study is to test the hypothesis that treating PAH-CHD patients     preoperatively with PAH drugs and keeping them on treatment for six months after surgery     reduces the risk of immediate postoperative death and the risk of residual PAH at six months     following operation to <10%.   "
132630|NCT01548937|"     This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20     AD depressive); each evaluable subject involved in this study must fulfill all the inclusion     and exclusion criteria according the subject grouping.      Safety measurement will be evaluated by medical history, vital signs, physical examinations,     laboratory examinations and collecting of adverse events.      This study is expected to be completed in a period of 3 years.   "
132631|NCT01548924|"     The investigators plan to study the determination of the dose and the combination of     antiangiogenic effect of dovitinib and cytotoxic activity of weekly paclitaxel in different     types of malignant tumors.   "
132632|NCT01548911|"     This clinical trial studies the side effects of gemtuzumab ozogamicin and how well it works     in treating patients with acute myeloid leukemia. Monoclonal antibodies, such as gemtuzumab     ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to     grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them   "
132633|NCT01548898|"     Laser causes elimination and miniaturization of hair shafts that are the principal     contributor to inflammation in Acne Keloidalis Nuchae (AKN).   "
132634|NCT01548885|"     The purpose of this study was to evaluate the performance of one investigational Bayer Blood     Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring     Systems from other companies. All meter BG results were compared with plasma results obtained     with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five     systems was evaluated across the glucose range of the BGMSs using capillary blood. All     testing and lancing were performed by study staff and some blood samples were glycolyzed to     lower the glucose levels.   "
132635|NCT01548872|"     The purpose of this study is to compare two different cardioplegia solutions effect on     postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.   "
132636|NCT01548859|"     The purpose of this study is to compare two different anaesthetic agent effect on     postoperative Troponin I levels in pediatric cardiac surgery   "
132637|NCT01548846|"     This is a study whose main objective is to evaluate prospectively the proportion of patients     with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.   "
132638|NCT01548833|"     The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1®     silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel     daily disposable contact lenses.   "
132639|NCT01548820|"     On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients   "
132640|NCT01548807|"     This is a Phase 1 dose escalation study of an investigational agent, everolimus, given in     combination with standard radiation therapy, in prostate cancers with a rising PSA following     a prostatectomy. A maximum of 33 people will be enrolled on this study at the University of     Pennsylvania. The primary objective of this study is to determine the acute and chronic     toxicities and maximum tolerated dose of everolimus with concurrent radiation.   "
132641|NCT01548794|"     The purpose of this study is the investigation of whether adding lidocaine to hyperbaric     bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter     recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy     procedures.   "
132642|NCT01548781|"     Disturbances in movement coordination are the least well understood but often the most     debilitating with respect to functional recovery following stroke. These deficits in     coordination are expressed in the form of abnormal muscle synergies and result in limited and     stereotypic movement patterns that are functionally disabling. The result of these     constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow     flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an     individual with stroke when they lift up the weight of the impaired arm against gravity. The     investigators previous neurotherapeutic research, supported by a NIDRR Field Initiated     research grant, has shown that the abnormal synergy between shoulder abduction and elbow     flexion can be significantly reduced thus increasing total reaching range of motion in     individuals with severe stroke. The previous work established progressive abduction loading     as a key element to the rehabilitation of reaching. Although individuals with severe stroke     benefited from the investigators previous work, residual flexion synergy continued to hinder     normal arm function in most participants with severe stroke. This study will utilize the     ACT3D robot, developed as part of the investigators previous NIDRR project, to incorporate     resistance to reaching while accounting for the known benefits of progressive abduction     loading. The investigators propose to randomize forty participants with severe stroke into     two closely related interventions. The groups will both practice reaching under abduction     loading, however, the experimental group will also move against resistance while reaching.     Rigorous and quantitative investigation of therapeutic elements such as resistance to     reaching and progressive abduction loading is only possible with a device such as the ACT3D.     the investigators will be able to standardize the delivery of each intervention using     kinematic and kinetic parameters, which will allow for a clear identification of the     therapeutic effect of resistance to reaching. the investigators hypothesize that resistance     to reaching in combination with progressive abduction loading will further increase dynamic     multi-joint strength, increase total reaching range of motion, and increase arm function thus     enhancing actual amount of use of the arm, participation in life roles, and quality of life     in individuals with severe stroke.   "
132672|NCT01548391|"     This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171     in healthy male subjects.   "
132646|NCT01548729|"     Patients with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD) may     benefit from combined lung-pancreatic islet transplantation. A recent case series showed that     combined bilateral lung and pancreatic islet transplantation is a viable therapeutic option     for patients with end-stage CF and CFRD. The use of different organs from a single donor may     lead to reduced immunogenicity. As the prevalence of CFRD has increased dramatically with the     improved life expectancy of patients with CF, islet transplantation should be considered at     the end-stage CF. By restoring metabolic control, the investigators hypothesize that islet     transplantation may improve the management of CF patients undergoing lung transplant and     decrease the complication rate in the early postoperative period.   "
132647|NCT01548716|"     Hypothesis:      25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than     those in HD patients with itching      25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and     compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of     patients complaining of itching.   "
132648|NCT01548703|"     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     BCI-838 and its metabolite BCI-632 in healthy male and female subjects.   "
132649|NCT01548690|"     This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute     liver failure/acute liver injury (ALF/ALI) in regard to:        -  safety and tolerability;        -  metabolism of the compound to glutamine and phenylacetylglutamine (PAGN);        -  its effect on circulating ammonia levels and neurological function in patients with and          without impaired renal function after continuous infusion at different infusion rates.      Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day     follow-up visit post infusion. It is anticipated that this early safety and tolerability     study, with appropriate PK/PD data, will lead to a development program for the use of OCR-002     in the treatment of hyperammonemia either due to ALF or possibly other liver conditions. The     hypotheses are:        -  Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute          liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune          hepatitis, viral hepatitis or indeterminate etiologies.        -  A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations          within 6-12h with little additional accumulation in the ALI/ALF setting.        -  Treatment with OCR-002 will reduce ammonia and improve neurological function in patients          with acute liver failure/severe acute liver injury.   "
132650|NCT01548677|"     This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer     (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating     tumour cells (CTC) in peripheral blood.      Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the     observation arm.   "
132651|NCT01548664|"     The purpose of this study is to identify whether the utilization of the Nintendo Wii™ gaming     system, as an adjunct to conventional outpatient rehabilitation therapy, influence outcomes     of patients following total knee replacement (TKR). The investigators hypothesize that the     Nintendo Wii™ gaming system has a positive influence in the outcomes of patients following     TKR.   "
132652|NCT01548651|"     The purpose of the study is to examine the effect of saxagliptin, an anti-diabetes     medication, on hepatic and myocardial fat content and monocyte inflammation in patients with     Impaired Glucose Tolerance (IGT).   "
132653|NCT01548638|"     This is a preliminary open-label study to determine whether a medication called galantamine     (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that     smokers experience during a quit attempt.   "
132654|NCT01548625|"     Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular     events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as     a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of     the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant     defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure     on the cardiovascular system in healthy middle-aged subjects.      Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype     had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3,     200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.   "
132655|NCT01548612|"     In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain     unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO     is a gas with unique chemistry and influences the release of neurotransmitters, learning,     memory and neurodevelopment. Recent studies that investigated the role of NO in patients with     schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in     schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO     donor, will ameliorate schizophrenia symptoms.   "
132656|NCT01548599|"     This pilot study aims to determine whether an agricultural intervention will improve food     security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV     transmission risk among people living with HIV/AIDS. The intervention will include: a) a     human-powered water pump and other required farm commodities, b) a micro-finance loan (~$75)     to purchase the pump and agricultural implements, and c) education in sustainable farming     practices.   "
132673|NCT01548378|"     The purpose of this study is to evaluate whether intramuscular injections of NL003 into the     calf is safe and effective in the treatment of critical limb ischemia   "
132657|NCT01548586|"     Transcranial direct current stimulation (tDCS) is a non invasive, painless, harmless way to     modulate cerebral cortex excitability. It was shown that anodal stimulation increases     cortical excitability and the cathodal one decreases it (Nitsche and Paulus, 2000; Lang et     al. 2004). To date, there is no data in the literature regarding the effect of tDCS on the     corticodiaphragmatic pathways. This preliminary study aims to test and validate the     modulating effect of tDCS on the excitability of the primary motor cortex dedicated to the     hemi-diaphragms in a sample of healthy subjects, as a prelude to further large studies in     patients with paretic hemi-diaphragms. Diaphragmatic motor evoked potentials will be assessed     before and after applications of three different modalities of tDCS (anodal, cathodal and     placebo).   "
132658|NCT01548573|"     This study is designed to decrease toxicity associated with prior tandem transplant protocols     by reducing the intensity of induction, consolidation and maintenance therapy, while     increasing event-free survival by adding bortezomib (Velcade®), thalidomide, gemcitabine and     carmustine to the transplant regimens to down-regulate the rescue of myeloma cells by the     micro-environment and to prevent DNA repair post high-dose alkylating agent therapy. By     reducing drug resistance, it is hoped that 3-year event-free survival will be increased     significantly when compared to Total Therapy II. Additionally, participants will have the     option of providing biospecimens for a sub-study evaluating gene expression profiling at     specific timepoints to better understand drug-resistance in myeloma, and to determine whether     there are genes or gene products in the resistant population that can be targeted by novel     therapies.   "
132659|NCT01548560|"     This is a study to determine the safety of dapivirine gel and dapvirine film for healthy,     HIV-uninfected women aged 18-45 years using the product for 7 daily doses.   "
132660|NCT01548547|"     This study aims to compare the clinical efficacy of multimedia audiovisual training to hands     on practice till perfect training for pediatric and emergency medicine residents'     procedural skills. This initial study will explore the success rates on infant lumbar     puncture and child intravenous access skills in post-graduate year one pediatric residents.   "
132661|NCT01548534|"     The aim of this study is to increase, by DHA-induced chemosensitization, the activity of     anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a     nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).   "
132662|NCT01548521|"     Background: Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder     arising from the lack of expression of paternally inherited imprinted genes on chromosome     15q11-q13. The syndrome includes severe neonatal hypotonia with impaired suckling leading to     failure to thrive in the most severe cases, subsequently followed by an early onset of morbid     obesity with insatiable hunger, combined with other endocrine dysfunction probably due to     hypothalamic dysfunction. The pathophysiological mechanism of the occurrence of the 2 main     nutritional phases of PWS is unknown. A deficit in the oxytocin (OT)-producing neurons of the     paraventricular nucleus in the brain of these patients has been reported. In addition of its     well-known anorexigenic effect, OT is involved in establishing and maintaining social codes.     Indeed, we have recently shown in a double blind placebo study, that OT administration to     adult patients with PWS significantly decreased depressive mood tendencies and tantrums while     increasing trust in others with some data on a trend to decrease appetite with higher     satiety. Moreover in a PWS mouse model generated from a MAGEL2 KO gene a single OT injection     at 5 hr of life prevent the early death observed in 50 % of the new born mice by recovering     normal suckling. Interestingly this effect is no longer observed if OT injection takes place     later. These data, OT deficit in PWS, good tolerance of OT and its effect after intranasal     administration in adult patients with PWS and the recent striking data obtained in the MAGEL2     mouse model, prompted us to evaluate the tolerance of a single administration of intranasal     OT in PWS newborns and its possible effect on suckling and food intake. Nowadays the     diagnosis of PWS is done during the first months of life in our country. At this age,     children still present with poor suckling suggesting that OT may be still efficient. Moreover     in adult patients with PWS we have shown that OT improves some typical behavioral troubles.     Therefore we first want to evaluate the tolerance of the intranasal administration of OT in 6     infants with PWS genetically confirmed and its effect on suckling, milk intake and weight     gain.   "
132663|NCT01548508|"     The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation     (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment     could improve functional exercise capacity.   "
132664|NCT01548495|"     The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum     patients who had an inadequate response or did not respond to Recombinant human     erythropoietin (rHuEPO) treatment.   "
132665|NCT01548482|"     This phase I trial studies the side effects and the best dose of trebananib and temsirolimus     when given together in treating patients with solid tumors that are metastatic or cannot be     removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to     the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving trebananib with temsirolimus may be an effective treatment for     solid tumors.   "
132666|NCT01548469|"     The hypothesis of this study is that using Bio Mineral toothpaste for 4 weeks will decrease     plaque and gingivitis of mild periodontitis patients compared to patients using Perio Total     Care toothpaste.      This study is Single blind, Randomized, Active-controlled Comparative clinical trial to     evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral     toothpaste in patients with mild periodontitis.   "
132667|NCT01548456|"     This is a prospective observational study of patients with femur fractures in Dar es Salaam,     Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open     reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of     reoperation for any reason, and the secondary outcomes are fracture healing, return to work,     and health-related quality-of-life. The investigators hypothesize that there will be a     difference in the rate of reoperation for patients with femur fractures treated with an IMN     compared to ORIF with a plate.   "
132668|NCT01548443|"     The wound healing efficacy and safety of Medifoam H in patients with minor, acute trauma.      The hypothesis of this study is that using Medifoam H dressing for a week is not inferior     to using Duoderm THIN dressing in wound healing.   "
132669|NCT01548430|"     The purpose of the study is to examine the safety, tolerability, immunogenicity and     pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive     impairment.   "
132670|NCT01548417|"     The primary hypotheses under test are that alcohol dependent subjects treated with     mifepristone will report decreased craving for alcohol following alcohol exposure in the     laboratory and report significantly less drinking under naturalistic conditions, than those     treated with placebo.   "
132671|NCT01548404|"     To assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668/SAR231893 in     adult patients with moderate-to-severe atopic dermatitis (AD).   "
132749|NCT01547390|"     This is a randomized controlled trial to estimate the efficacy of low dose aspirin for     preventing preeclampsia in women identified as high risk. The investigators hypothesize that     the risk of preeclampsia in women identified by a first trimester multiparameter predictive     model to be at high risk will be significantly reduced by initiating low dose aspirin early     in pregnancy.   "
132916|NCT01545180|"     This study will better understand the post-capillary pulmonary hypertension in heart failure,     to determine its prognostic role and to consider specific treatment of different forms of     pulmonary hypertension in post-capillary pulmonary heart failure.   "
132675|NCT01548352|"     Syncope is a major health problem. In the emergency department (ED), the management of     patients with syncope still remains a clinical challenge because underlying diseases and     prognosis can be extremely various. Structural heart disease and primary electrical disorders     are major risk factors for sudden cardiac death and mortality in patients with syncope. In     contrast, patients with reflex syncope and exclusion of structural heart disease have an     excellent prognosis.      Therefore The investigators test the hypothesis that the use of a meticulous patient history,     clinical examination and novel biomarkers can improve the rapid and accurate diagnosis of     cardiac syncope in patients presenting to the ED and is able to improve risk stratification     regarding adverse outcomes.      The prospective multicenter cohort study is designed to enroll 720 patients presenting with     transient loss of consciousness within the last 12 hours to the ED. Blood samples for the     measurement of novel biomarkers will be obtained at presentation.      All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse     events (death, resuscitation, recurrence of syncope, hospitalization for syncope).   "
132676|NCT01548339|"     The purpose of this study is to compare the clinical outcomes of early versus delayed     laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.   "
132677|NCT01548326|"     The purpose of this study is to determine whether short-term Atorvastatin can increase the     immunity response to hepatitis B vaccination in vaccine Nonresponders.   "
132678|NCT01548313|"     The ideal food for normal infants is human milk. In addition, breast milk has been shown to     be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they     play a key role in the initiation and development of the gut microbiota. Intestinal     colonization is essential for maturation of the gut-associated lymphoid tissue (GALT) and the     homeostasis of the intestinal epithelium. Colonization begins immediately after birth, while     later the composition of the gut microbiota is affected by feeding practices. Results of some     studies suggest that long-chain polyunsaturated fatty acids (LCPUFAs) promote the adhesion of     probiotics to mucosal surfaces and along with probiotic bacteria contribute to the regulation     of innate and adaptive immune responses and present a link among mother's diet, and microbes.     The main purpose of the proposed research is to establish the link among mothers' nutrition,     human milk LCPUFAs composition and microbiota and their potential influence on child's gut     microbiota development. Pregnant women from three different regions of Slovenia will be     involved into the study. Dietary intakes will be assessed during pregnancy, at the beginning     of the 3rd trimester of pregnancy, and during lactation, at 4 weeks post partum, by 7-day     weighed dietary protocol (7DP). Human milk (colostrum, and mature human milk) and infant's     faeces will be sampled twice: at 2 or 3rd day post partum (meconium) and at 4 weeks post     partum for the determination of human milk LCPUFAs composition and the assessment of human     milk (colostrum und mature) and faeces microbiota. The fatty acid composition of human milk     will be analysed by capillary gas-liquid chromatography (GC). Microbiota of milk and faeces     will be studied using conventional microbiological and modern molecular approach such as     qualitative and quantitative PCR amplification of informative genomic regions, DGGE/TGGE     and/or t-RFLP and sequencing. Regular monthly meetings with the researchers will be organised     for discussion and advising. Basic health parameters of infants will be followed. Data will     be gathered from maternity department medical charts, from regular paediatric health care     visits and from especially designed health care diary each mother will keep until the end of     her child's first year.   "
132679|NCT01548300|"     The investigators posit that a multi-national collaborative effort with focused     investigations in environments with the highest levels of exposure (developing countries such     as China and India), are likely to provide new and much needed data on the risk posed by     these variables on an individuals life-time risk for type 2 diabetes and cardiovascular     complications. The investigators will test this hypothesis through the establishment of a     network that would lead studies on the links between exposure and adverse Chronic     cardiometabolic effects and propose doing this in this as part of 3 specific aims.   "
132680|NCT01548287|"     This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease     or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is     to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.   "
132681|NCT01548274|"     The purpose of this study is to evaluate the effects of Sarpogrelate in endothelial     progenitor cells of patients with atherosclerosis.   "
132682|NCT01548261|"     Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have     good clinical results in treating patients with ocular surface disorders in both human and     animal studies. However, such technique has not been well established in this hospital. The     main purpose of this study is to obtain the discarded oral mucosal tissue from healthy donors     who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal tissue     will be cultured under different types (co-culture with or without 3T3 cells)。Inverted light     microscopy, electron microscopy and immunostaining with K3/K12, K14, Ki67, P63, connexin 43,     and involucrin will be preformed to test the effects of foreskin cell line co-culture system     on cell condition. The investigators plan to start the study from Jan. 1st, 2011 to Dec.     31th, 2015. Thirty patients will be enrolled.   "
132683|NCT01548248|"     This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety     of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and     incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes     treated with insulin NPH under normal clinical practice conditions in Slovakia.   "
132684|NCT01548235|"     This study is conducted in Europe. The aim of this study is to investigate safety and     efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin     aspart 30 (NovoMix® 30) treatment.   "
132685|NCT01548222|"     This is a trial to determine if patients who are well controlled and on basal insulin are     treated with excessive basal dose.   "
132686|NCT01548209|"     Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine     was reported to a reduced PONV due to opioid-sparing effect. It is not clear if     dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study:     intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than     placebo for reducing of PONV and improve postoperative quality of recovery score within 48     postoperative hours.   "
132748|NCT01547403|"     The primary objective of the CUSTOM study is to respond to customer support issues (outside     of the US) and to assess the impact of a particular treatment or perturbation relative to an     initial control measurement. Sequential subject measurements will be analyzed to determine if     a given action or condition induces a score shift, an inflation of measurement variance or     elevated outlier rates.   "
132774|NCT01547065|"     The investigators hypothesize that transesophageal echocardiography is a valid method to     obtain renal doppler hemodynamics2, 4. The goal of this study is to determine if there is a     correlation between abnormal TEE resistive index measurements, intraoperative events and     post-operative creatinine changes   "
132687|NCT01548196|"     The purpose of the study is to assess and compare the efficacy and morbidity standard     percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be     enrolled. Patients will be randomized to one of four groups: standard percutaneous     nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or     ureteral stent/catheter. Primary Outcome Measures will include length of procedure and     estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores,     time to ambulation, time to oral intake, and pain scores will also be recorded. Time to     nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge     from the hospital will also be recorded. Incidence and type of post-operative complications     will also be recorded.   "
132688|NCT01548183|"     The US preventative services task force (USPSTF) recommends behavioral counseling in the     primary care setting for prevention of sexually transmitted diseases, however, screening and     counseling rarely occur. Text messaging (TM) is increasingly being used as a tool to affect     behavior change in patients, but its effect on patients that report at-risk sexual behavior     in the emergency department (ED) is unknown. The investigators seek to assess the feasibility     of ED-based screening of young adult females for at-risk sexual behavior and enrolling them     in a 3 month trial using TM to deliver information and skill building to improve health     behavior.   "
132689|NCT01548170|"     Sunitinib is an ATP competitive tyrosine kinase inhibitor of several membrane receptors     including VEGFR-1, -2, and -3, PDGFR-α and -β, c-KIT, CSF-1R, FLT-3, and RET. Through this     molecular mode of action, sunitinib is able to avoid tumoral angiogenesis and proliferation.     Sunitinib is already approved by the FDA, EMEA and AEMPS for the treatment of patients with     metastatic renal cell carcinomas and those with metastatic gastrointestinal stromal tumors     (GIST) with progression or intolerance to imatinib.      Suntinib has recently reported to be superior than placebo in terms of response rate (9.3%     vs. 0%; p<0.05), progression free survival (11.4 vs. 5,5 months; HR 0.41;p<0.05), and overall     survival (HR 0.40;p<0.05) when administered in a phase 3 trial to patients with advanced     pancreatic neuroendocrine tumors (NETs).      Sunitinib is an expensive drug that drains the budget of health public system therefore it     demands a rational drug use.      Sunitinib is metabolized by CYP3A4, that belongs to the P450 cytochrome system in the liver.     Most of the drug is eliminated in faeces and only 16% by urine. Sunitinib has no food-effect     when taken with meals. Pharmacokinetics parameters did not differ between cancer patients and     healthy volunteers.      Houk et al. Showed that the area under the curve of plasmatic concentration of sunitinib and     its active metabolite did correlate with clinical outcome. In other words, the higher plasma     concentration area under the curve the highest rates of radiological response, progression     free and overall survival rates.      Ketoconazol is an antifungal drug that inhibits the CY3A4 inducing an elevation of peak     plasma levels of other drugs administered simultaneously and that are metabolized by the same     system. In the labeling sheet of sunitinib it is said that ketoconazol induced a 49% and 51%     of increase of plasmatic sunitinib Cmax y AUC0-∞ when both drugs were administered together.     This fact makes that the investigatorspropose that by administering both drugs simultaneously     the investigators could reduce sunitinib dose by a lower metabolization with similar plasma     concentration. The dose reduction would impact in drug cost.      Here the investigators propose to determine the most optimal combination dose of sunitinib     (25 mg or 37.5 mg) and ketoconazol (200mg o 400mg) by which the investigators could have     plasmatic bioequivalent concentrations compared with single dose of sunitinib 50mg.      Each volunteer will be assigned to a treatment arm (Arm A and Arm B). Volunteers included in     Arm A will take: sunitinib 50 mg, sunitinib 37.5 mg + ketoconazole 200 mg and sunitinib 37.5     mg + 400 mg ketoconazole. Volunteers included in Arm B will take: sunitinib 50 mg, sunitinib     25 mg + ketoconazole 200 mg and sunitinib 25 mg + 400 mg ketoconazole   "
132690|NCT01548157|"     The purpose of this study is to evaluate pharmacokinetics and safety after oral     administration of HCP1007 capsules and Rosuvastatin plus Omega-3.   "
132691|NCT01548144|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed)     or of the combination of 3 study drugs that can be given to patients with advanced cancer.     The safety of these drug combinations will also be studied.      Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth     and survival.      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for     tumor growth. This may prevent or slow the growth of cancer cells.      Pemetrexed is designed to block proteins that may cause tumors to grow.   "
132692|NCT01548131|"     Site of research: Helsinki University Central Hospital (HUCH), Department of Obstetrics and     Gynaecology and University of Helsinki Department of Psychology, in collaboration with     Karolinska University Hospital in Stockholm, Sweden      In Finland and in Sweden, fear of childbirth is one of the most common reasons for     consultation of obstetrician, and for an elective caesarean section. Approximately 5 to 6% of     pregnant women suffer from severe fear of childbirth, which disturbs family-life and working     and prevents the preparation to normal childbirth and parenthood. It represents as     nightmares, panic attacks, anxiety, and as numerous physical complaints. After giving birth     it can be difficult for these women to form an early mother-infant-relationship. Their risk     for puerperal depression is also increased.      Finland and Sweden have both a long tradition in research of this field. In Finland, the     investigators research group started the first out-patient clinic for fearful pregnant women     in HUCH in1996. Different strategies how to treat fear of childbirth have been applied to     clinical practise. Studies on the treatment for fear of childbirth are, however, scanty. Some     descriptive studies have showed that far more than one half of patients can, after the     treatment, prepare to a normal vaginal delivery and caesarean without a medical indication     can be avoided. The aim of the treatment should be both to avoid unnecessary caesareans,     increase the number of uneventful vaginal deliveries and to help the pregnant couple to     prepare to parenthood, as well as to prevent puerperal depression.      In this study, psychotherapeutic group psychoeducation is studied as promising treatment for     severe fear of childbirth. To screen fear of childbirth, all women coming to ultrasound     screening at the 18 to 20 gestational week in HUCH are asked to fill in a specific     questionnaire. Those nulliparous women whose score for fear exceeds 95th percentile are     randomized to intervention and to control group.      The intervention group is invited to start a psychotherapeutic group therapy based on     cognitive and psychodynamic therapy combined with training in relaxation. Each group consists     of six nulliparous women and meets six times during pregnancy 120 minutes at a time. Between     the sessions the patients fill in a homework questionnaire. One session focuses on the     partner's role and the partners are present then. Three months after delivery, the groups     meet once more.      The women in the control group stay in the care of community midwives and general physicians.     If needed, they are referred to out-patient clinic in the maternity hospital where their fear     is treated according the clinical practice of that hospital, mainly support from obstetrician     or midwife.      The women and their partners in both groups are asked, approximately one month after the     screening and one month before the due date of delivery, to fill in the questionnaires     examining depression, self-esteem, general anxiety, social support, marital satisfaction,     personal projects and concerns, and efficacy concerning childbirth and maternity. After     childbirth, data about the childbirth will be collected. Three months and two years after     childbirth mothers and fathers in both groups receive again a psychosocial questionnaires.      The aim of the study is to help the authorities to organize the treatment for fear of     childbirth in their districts by examining the benefits of the treatment also in long-run.     The investigators hope the results would lead to production of Current Care guidelines for     fear of childbirth.   "
132693|NCT01548118|"     This study will evaluate the safety of a novel recombinant human papillomavirus bivalent (     types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years     of age at enrollment.   "
132694|NCT01548105|"     Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found     to be associated with severe POP. The authors' proposed explanation was that smoking impairs     tissue and wound healing. Our primary objective is to document whether smokers with pelvic     organ prolapse (POP) are different from non-smokers with POP with respect to collagen     biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.   "
132695|NCT01548092|"     The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the     treatment of recto-vaginal fistula.   "
132696|NCT01548079|"     In an open-label trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric     surgery will be administered 20 mg/kg/day ursodeoxycholic acid for three weeks until the day     before surgery. The maximum dose will be 3 g/day. Twenty other patients will serve as     controls. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a     complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and     fibroblast growth factor 19 (FGF-19), markers for bile acid synthesis its intestinal     stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will     be taken for the estimation of homeostasis model assessment (HOMA) index and oral glucose     tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1     g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in     liquid nitrogen for messenger ribonucleic acid (mRNA) and protein preparation for     quantitative real-time polymerase chain reaction (RT-PCR) and Western analysis, respectively,     histopathological Non-alcoholic fatty liver disease (NAFLD) grading, and measuring of hepatic     and white adipose tissue (WAT) lipase activity. In all patients at randomization, abdominal     ultrasound will be performed for the detection of NAFLD and gallstones and a blood sample     will be taken for the analysis of polymorphisms of hepatic lipid synthesis, storage, fatty     acid (FA) oxidation and export genes. Six month after operation, HOMA, OGTT and abdominal     ultrasound will be repeated.   "
132697|NCT01548066|"     Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and     regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at     low level through regulation by GSK-3, multifunctional serine/threonin kinase. After     phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore,     inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce     growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for     decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been     studied yet.   "
132698|NCT01548053|"     Alzheimer's disease (AD) and related forms of dementia currently affect over 400,000     individuals in Canada and the numbers of community dwelling older adults with AD is rapidly     growing. AD is associated with over $15 billion annually in care costs. Most individuals with     AD are under the care of primary care providers (PCPs) including family physicians and     primary care nurses. The evaluation and management of AD is challenging for PCPs and the     quality of care provided to older adults with AD by PCP could be improved which would     optimize outcomes for this vulnerable population. Provision of quality care to older adults     with AD involves implementation of best practices as outlined in guidelines such as the     Canadian Consensus Conference Guidelines on the Diagnosis and Treatment of Dementia.     Utilizing a group of dementia researchers, PCPs, other knowledge users, and individuals     affected by AD, this project will develop practical, clinically relevant resources for     primary care physicians and nurses to aid in the evaluation of older adults with AD. A     knowledge tool, the Primary Care - Dementia Assessment and Treatment Algorithm (DATA Tool)     will be introduced into several primary care settings in Ontario using educational sessions     with PCP with additional support from internet resource and a dementia care manager. The     quality of dementia care provided to older adults newly diagnosed with AD will be assessed in     the three years preceding the intervention compared to the year following the implementation.     This project will also describe the process of knowledge exchange with PCPs, including     potential barriers and facilitators of knowledge uptake and examine if the care provided     during the intervention was patient-centred through interviews with patients and caregivers.      Research Objectives:        1. Develop knowledge tools to facilitate assessment and treatment of AD by PCPs based on          best evidence;        2. Transfer these knowledge tools into a variety of primary care settings in Ontario; and,        3. Evaluate the effects of this intervention on dementia quality of care, PCP application          of knowledge, and the patient-centeredness of care.   "
132699|NCT01548040|"     The study is a double-blind randomized controlled clinical trial.Approximately 118 patients     (males and females) who are at least 40 years of age, who are scheduled for total-knee     arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab     XP and a standard rehabilitation program and 2) a control group who receive only a sham     device and a standard rehabilitation program. Patients are tracked for measures of function,     pain, quality of life, physical performance and acceptable states status at 6 weeks and 1     week before surgery and 3, 6, 12, and 52 weeks following surgery.      Hypothesis 1: The effect of 12-weeks of Kneehab XP (peri-operative NMES) combined with     standard rehabilitation in patients undergoing TKA surgery will lead to increased quadriceps     strength compared to a control group at the 6 week post-operative time point.      Hypothesis 2: The effect of 12-weeks of Kneehab XP (peri-operative NMES) combined with     standard rehabilitation in patients undergoing TKA surgery is better than the control group     as measured by PASS at post-operative week 6. The investigators hypothesize that a     significantly larger proportion of patients will indicate a positive PASS in the Kneehab XP     group compared to the control group.      Hypothesis 2:The investigators hypothesize that the mean change scores for pain, physical and     functional performance measures will be significantly better for the Kneehab XP group at post     operative week 6. Additionally, the investigators report the baseline corrected scores for     these outcomes, as well as the primary and secondary outcomes, at all the other follow up     time points.   "
132700|NCT01548027|"     The objective of this study to determine the effect of surgical transversus abdominis plane     block and local infiltration for postoperative pain control in major abdominal surgery     compare with control group.   "
132701|NCT01548014|"     The purpose was to evaluate as to whether administration of infliximab of 12 week interval     with supplementary VSL#3 is more effective or at least of similar efficacy when compared to     conventional administration of infliximab only of 8 week interval.   "
132702|NCT01548001|"     This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod     in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid     Arthritis (RA).   "
132703|NCT01547988|"     The purpose of this study was to evaluate the effect of a group-based functional and specific     balance training program on balance function in healthy older adults. It is commonly     considered difficult to improve balance function in healthy older adults. The program     included dual-task exercises; physical training exercises and a cognitive task (e.g. reading     or reciting a story) performed simultaneously, as well as perturbation exercises, where     balance is challenged in unexpected ways.      The investigators hypothesized that following the proposed training, older adults would     improve their speed of taking a step in both single and dual task conditions, refine their     ability to control balance when standing still and improve their self-reported physical     function.   "
132704|NCT01547975|"     Currently, no demographic and surgical results comparing different donor cornea sources were     available in Taiwan. National Taiwan University Hospital (NTUH), as one of the largest     tertiary medical centers in northern Taiwan, is now in charge of a big part of intense care     for patients receiving corneal transplantation. With detailed medical record done of these     patients during care in the ward and out-patient clinic, the investigators are competence for     this meaningful program.   "
132705|NCT01547962|"     The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a     free autogenous graft using donor tissue harvested from the subject's palate in the treatment     of subjects who have an insufficient zone of attached gingiva associated with at least two     non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment     and control in the change in amount of attached gingiva over the 6 month observation period.      Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft     will be placed in the other. The grafts will be evaluated clinically to determine the change     in the amount of attached gingiva and on at least three subjects, a small biopsy will be     taken to allow histologic evaluation and comparison of both grafts.   "
132706|NCT01547949|"     The purpose of this study is to assess the effects of tart cherry juice to reduce serum     biomarkers of inflammation and reduce muscle soreness in healthy adults who undergo a bout of     controlled eccentric exercise.   "
132707|NCT01547936|"     The purpose of this study is to evaluate the effect of the controlled adverse environment     (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.   "
132708|NCT01547923|"     The aim of this study is to demonstrate the medical and financial benefit of pre-therapeutic     screening of DPD deficiency for predicting toxicity to fluoropyrimidines.   "
132709|NCT01547910|"     The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with     non-alcoholic fatty liver disease.   "
132710|NCT01547897|"     Primary objective:      - To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine     ratio (ACR) in patients with type 2 diabetes and albuminuria      Secondary objectives:        -  To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)        -  To evaluate the effect of study drug on markers of glycemic disorders, systemic          inflammation, renal and liver disease and cardiovascular function        -  To assess the safety and tolerability of study drug        -  To determine the population pharmacokinetics (PK) of study drug   "
132711|NCT01547884|"     Background:      - Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is     spread by mosquitoes, and causes fever, chills, and headaches. If untreated, it can also     cause elephantiasis, a condition that leads to swelling of the arms, legs, breasts, and     scrotum. Treatment can eliminate the worms from the blood and reduce the risk of developing     elephantiasis. Researchers want to study people with latent tuberculosis (TB) who may or may     not be infected with filariasis. This study will look at the way that people with latent TB     fight infection with these worms.      Objectives:      - To study how the immune systems of people with latent TB react to filarial infection.      Eligibility:      - Individuals between 18 and 65 years of age who have latent TB and may or may not have     filarial infection.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide a blood and stool sample to test for infection.        -  Participants who do not have lymphatic filariasis but have another kind of intestinal          worm will be treated for the parasite. This will be their last study visit.        -  Participants who have latent TB and lymphatic filariasis will be treated with the          standard treatment for the disease. They will come back for a second visit 6 months          later, and will provide another blood sample.   "
132712|NCT01547871|"     Background:      - Spinal muscular atrophy type 1 (SMA 1) causes severe muscle weakness and problems with     eating and breathing. The symptoms begin in infancy, and children affected with SMA 1 often     die in early childhood. Researchers want to collect information on how SMA symptoms progress     in first two years.      Objectives:      - To study how the symptoms of SMA 1 progress in infants and children.      Eligibility:      - Infants and children with SMA 1 born on or after January 1, 2007.      Design:        -  Researchers will review the child s medical records and talk with parents by telephone.        -  For children who are under 2 years of age, the researchers will review the child s          medical records and speak with you on telephone every 2-4 months. Phone calls with          parents will take about 10 minutes and will involve questions about symptoms of SMA 1.          Children will be followed until age 2.- Researchers are also interested in looking at          medical records of children who are no longer alive or who are more than 2 years of age.      Parents or children do not have to come to the NIH. They will provide consent to view these     records, and information over the telephone.      - No treatment or care will be provided as part of this study.   "
132713|NCT01547858|"     Background:      - Formaldehyde has many uses in industry and medicine. However, exposure to formaldehyde has     been associated with increased risk for myeloid leukemia. There are still questions about how     the chemical reacts with bone marrow to increase this cancer risk. Some smaller studies have     looked at how it affects stem cells, which are found in bone marrow. Researchers want to     develop a much larger study of workers in China. The study will look at different levels of     formaldehyde exposure. It will focus on how the chemical affects the blood cells and bone     marrow.      Objectives:      - To study the effects of formaldehyde exposure on blood cells and bone marrow.      Eligibility:      - Individuals between 18 and 60 years of age who work in selected factories in Guangdong     Province, China.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          be screened with a work history. Those who have been exposed to benzene, butadiene,          styrene, or radiation will not be included.        -  Participants will be studied based on their regular formaldehyde exposure level.          One-third will be those exposed to more than 1 part per million (ppm) of the chemical.          One-third will be those exposed to 0.3 to 1 ppm. A control group will have no exposure          to formaldehyde or any other known toxic chemical.        -  Participants will provide blood and cheek swab samples. They will also answer questions          about their work habits.        -  To look at chemical exposure levels, participants will wear a small monitor to work on 3          different days. They may provide additional blood and cell samples as directed.        -  No treatment will be provided as part of this study.   "
132714|NCT01547845|"     Background:      - Cancer and cancer treatments can cause symptoms and side effects. Pain, fatigue, and     emotional distress are three common symptoms. Accurate reporting of these symptoms can     improve treatment methods and outcomes. Even though symptom reporting is important to     treatment, there is no method to collect and compare patient data from multiple cancer care     centers. Researchers want to develop a method for collecting cancer patient symptom     information from multiple centers. This method may help improve cancer treatment at hospitals     and other care centers.      Objectives:      - To collect patient-reported symptom information from multiple cancer care centers.      Eligibility:        -  Individuals at least 21 years of age who were treated for breast or colon cancer in the          past year.        -  Participants will come from one of the participating cancer care centers.      Design:        -  Participants will answer a short questionnaire about their symptoms during cancer          treatment. Questions will ask about symptom severity and experiences. Other questions          will ask how well the doctors and nurses managed the symptoms.        -  Participant responses will be compared with other medical and personal information. This          information may include cancer type, age at diagnosis, and type of treatment.        -  Treatment will not be provided as part of this study.   "
132715|NCT01547832|"     Background:      - Early-onset Parkinson's disease (EOPD) is more likely to be caused by gene mutations than     Parkinson's disease that develops in older people. Studying these mutations may help find     therapies for EOPD. Researchers want to study mutations on a gene called PARK2. These     mutations prevent fat uptake into cells and may interfere with normal brain function.     Researchers want to study fat and cholesterol in the body to look at the effects of these     mutations on the body and brain.      Objectives:      - To study connections between genetic mutations and EOPD.      Eligibility:        -  Individuals between 18 and 80 years of age with EOPD.        -  Individuals between 18 and 80 years of age with no family history of Parkinson s          disease.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will also be collected.        -  Participants will have some or all of the following tests:        -  Blood samples and tissue (skin and fat) biopsies        -  Cell line development from these tissue samples to study the function of PARK2        -  DEXA scan to measure body fat context using low dose x-rays        -  Glucose and insulin tolerance testing to measure blood sugar levels.        -  Treatment will not be provided as part of this protocol....   "
132917|NCT01545167|"     This study will investigate several genes and other factors measured in the blood that may     cause recurrent acute pancreatitis and chronic pancreatitis.   "
132716|NCT01547819|"     Background:      - Some people who have a traumatic brain injury (TBI) recover completely. Others, however,     develop post-traumatic stress disorder (PTSD), with anxiety and depression. Research suggests     that levels of a brain chemical called GABA may differ in people with PTSD compared to those     without PTSD. Researchers want to see if TBI can affect GABA in the brain and help develop     PTSD. To look at the brain, researchers will use imaging studies with the chemical     11C-Flumazenil, which will help the scan show GABA levels in the brain.      Objectives:      - To study the relationship between PTSD and TBI.      Eligibility:      The subjects will be recruited from the Walter Reed National Military Medical Center     (WRNMMC).        -  Individuals between 18 and 50 years of age who have PTSD and/or had a mild TBI.        -  Healthy individuals between 18 and 50 years of age who have no history TBI and no          history of PTSD.      Design:        -  Participants will be screened with a physical exam and medical history. Urine and breath          samples will also be collected.        -  Participants will have two imaging studies, on the same day if possible. The first will          be a magnetic resonance imaging scan to look at the brain. The second will be a positron          emission tomography scan with the study chemical to look at GABA pathways in the brain.   "
132717|NCT01547806|"     Background:      - One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem     cell transplant. Researchers want to collect stem cells from the blood for later transplant.      Objectives:      - To collect stem cells for transplant as part of treatment for plasma cell myeloma.      Eligibility:      - Individuals at least 18 years of age who will have chemotherapy and stem cell transplant     for plasma cell myeloma.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have filgrastim injections for 5 days before collection. This will          move stem cells from the bone marrow to the blood.        -  Participants will have apheresis to collect the stem cells.        -  Participants who need additional apheresis procedures to collect stem cells will have          filgrastim and a dose of plerixafor to improve the collection yield.   "
132718|NCT01547793|"     Background:      - Some people with sickle cell disease have different health problems than others. This may     be related to how easily and frequently the red blood cells break apart in the blood.     Researchers want to test breath and blood samples from people with sickle cell disease to     look for very small amounts of carbon monoxide, which is produced when red blood cells break     apart. They will compare these results with breath samples from healthy volunteers. Studying     different levels of carbon monoxide may help predict what health problems a person with     sickle cell disease may get. It may also provide more information on possible treatments.      Objectives:      - To study breath carbon monoxide levels and their possible relation to the severity of     sickle cell disease.      Eligibility:        -  Individuals at least 18 years of age with sickle cell disease.        -  Healthy volunteers who are matched for age, sex, and race with the sickle cell disease          group.      Design:        -  Participants will be screened with a medical history.        -  Participants with sickle cell disease will provide a blood sample and have a heart          function test. They will also breathe into a bag to provide an exhaled breath sample.        -  Healthy volunteers will provide an exhaled breath sample.        -  No treatment or care will be provided as part of this study.   "
132719|NCT01547780|"     Background:      - People with traumatic brain injury (TBI) often have inflammation in the brain. A protein     called the translocator protein (TSPO) is often present with inflammation. Researchers want     to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and     inflammation in the brain of people with TBI.      Objectives:      - To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic     brain injury.      Eligibility:        -  Individuals at least 18 years of age who have had TBI and have had a brain scan that          shows signs of inflammation.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  All participants will have two brain scans during an outpatient visit. A magnetic          resonance imaging scan will study brain activity. A positron emission tomography (PET)          scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation.        -  Participants with TBI will have two PET scans within 10 days of the head injury, and a          PET scan around 90 days after the injury. They may also have MRI scans under this or          another study. Tests of thinking, memory, and concentration will be used to study the          effects of the injury and inflammation   "
132720|NCT01547767|"     Background:      - A mutation in a gene known as ISCU was found to be the cause of a rare myopathy that     affects the muscles. Researchers collected clinical samples from people with this myopathy.     More research is being done to develop a therapy for this disease. Researchers are asking for     permission to study the samples already collected.      Objectives:      - To allow researchers to use clinical samples collected to study new treatments for ISCU     myopathy.      Eligibility:      - People with ISCU myopathy who have provided clinical samples for study.      Design:        -  Participants will allow researchers to study clinical samples already collected. Blood,          urine, muscle, and cell samples may be used. Medical records and photographs may also be          studied.        -  Treatment will not be provided as part of this study.   "
132732|NCT01547611|"     Many patients with cervical disc disease have long-lasting and complex symptoms with chronic     pain, low levels of physical and psychological function and sick-leave. Surgery on a few     segmental levels might be expected to solve the disc-specific pain but not the non-specific     neck pain and the patients'illness. As much as 2/3 of the patients have been reported to have     remaining physical/ psychological disability long-term after surgery. A structured     physiotherapy programme after surgery may improve patients'function and return to work. The     main purpose of the study is to evaluate what a well structured rehabilitation program adds     to the customary treatment after surgery for radiculopathy due to cervical disc disease in     respect to function, disability, workability and cost effectiveness. The study is a     prospective randomised controlled multi-centre study, with an independent and blinded     investigator comparing two alternatives of rehabilitation. 200 patients in working age, with     cervical disc disease with clinical findings and symptoms of cervical nerve root compression     will be included after informed consent. After inclusion in the study patients will be     randomised to one out of the two alternatives of physiotherapy, (A) customary treatment     (information/ advice on the specialist clinic) or (A+B) active physiotherapy; standardised     and structured program of neck specific exercises combined with a behavioural approach plus     customary treatment. Patients will be evaluated both clinically and with questionnaires     before surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery. Main     outcome variable are neck specific disability. Cost-effectiveness will be calculated. The     inclusion will preliminary be closed 2012. The study could contribute to a better clinical     decision making, a better health care which will reduce physical, mental and social costs for     the patients, and improve the rates of patients returning to and staying at work.   "
132918|NCT01545154|"     This study is being done to find out if transperineal ultrasound (TPUS) can help define the     prostate gland for radiation treatment planning and improve upon current methods of image     guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement     of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are     lying on their back in the position they will receive their treatment. Image-guidance is     required for the treatment of prostate cancer because the prostate shifts position depending     on how full the bladder and rectum are. Image-guided radiation therapy has been done at     Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal     ultrasound images are obtained every day and compared to an ultrasound that was done on the     day of treatment planning. Adjustments in radiation field position can be done on a daily     basis by comparing these images. Transperineal ultrasound has never been used for     image-guidance. The investigators completed an earlier study and have developed a TPUS device     and process that allow us to get clear ultrasound pictures of the prostate gland. The TPUS     has three potential advantages over the transabdominal method the investigators currently     use:        1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get          clearer images, however it is difficult for some men with prostate cancer to comfortably          keep a full bladder. It is also particularly difficult to get good images in larger men          who have long distances from the skin surface to the prostate gland. TPUS is not          dependent on a man having a full bladder and should be less dependent on the size of the          man.        2. TPUS images and the planning CT images can be acquired simultaneously. This is not          possible with the abdominal probe because it gets in the way of the CT machine.          Simultaneous imaging eliminates the possibility of the prostate gland shifting positions          during the time between imaging studies.        3. TPUS can be in place and acquire images during patient treatment (the abdominal probe          gets in the way of the treatment machine) and may in the future allow us to watch the          prostate gland during treatment. If the investigators discover that they can accurately          view the prostate gland in real time, TPUS may ultimately allow us to treat even smaller          radiation fields and possibly decrease the risk of radiation complications.      Patients in this study will be treated for their prostate cancer with the standard image     guidance techniques used at Fletcher Allen Health Care: transabdominal ultrasound and/or     X-ray imaging of gold marker seeds that have been placed the prostate gland. In addition to     standard care, all men in this study will have TPUS and CT scans done a total of four times     over 12 weeks to compare these methods of prostate localization over the course of radiation     treatments. Some men may choose to take part in an additional study that will also include     MRI of the pelvis to compare with the TPUS and CT. Because the prostate gland can be more     clearly defined on MRI, some institutions (not Fletcher Allen) routinely have patients with     prostate cancer get MRI scans for treatment planning. This has not been proven to improve the     care of men with prostate cancer and it is possible that TPUS will provide similarly clear     images. The potential advantages to TPUS imaging for prostate localization over MRI include     the fact that it is done at the same time as the CT for treatment planning (so eliminates the     possibility of movement of the prostate gland from the time of the MRI to the time of the CT)     and can be done at a much lower cost.   "
132721|NCT01547754|"     Background:      - Some people with human immunodeficiency virus (HIV) develop problems with thinking and     concentration when the virus affects the brain. This is known as mild neurocognitive disorder     (MND). Research has shown that some HIV medications do not get through the blood brain     barrier very well. P-glycoprotein (P-gp) is a brain protein that is part of the blood brain     barrier. Differences in the activity of P-gp may help explain why some people with HIV     develop MND. It is also possible that MND is partly due to inflammation in the brain.     Researchers want to study P-gp and its effect on MND and HIV infection.      Objectives:      - To study P-gp and brain inflammation related to HIV infection.      Eligibility:        -  Individuals between 18 and 60 years of age who have HIV and either do or do not have          MND.        -  Healthy volunteers between 18 and 60 years of age.      Design:        -  Participants will be screened with a medical history and physical exam. Blood and urine          samples will be collected.        -  Participants will have one outpatient visit and one 3-day inpatient stay.        -  At the outpatient visit, participants will provide blood samples and have a lumbar          puncture (spinal tap). The spinal tap will collect cerebrospinal fluid for study.        -  At the inpatient visit, participants will have two positron emission tomography (PET)          scans of the brain. These scans will study brain activity and possible inflammation. One          scan will involve a study drug called tariquidar, which blocks the activity of P-gp. A          second lumbar puncture will be done before the first PET scan. Blood and urine samples          will be collected daily.   "
132722|NCT01547741|"     RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast     cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs     in different combinations may kill more breast cancer cells. Giving combination chemotherapy     after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This randomized phase III trial is studying different combination chemotherapy     regimens and their side effects and comparing how well they work in treating women with     non-metastatic breast cancer.   "
132723|NCT01547728|"     The objective of this study is to prospectively evaluate the response of recombinant     antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to undergo     cardiac surgery.   "
132724|NCT01547715|"     This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal     ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.   "
132725|NCT01547702|"     The purpose of this study is to evaluate, by way of randomized controlled trial, the     effectiveness of a web-based, time-flexible, and teacher-directed Teacher Help for ADHD     program in reducing the impact of ADHD symptoms in elementary students.   "
132726|NCT01547689|"     The primary purpose of this study is to evaluate the safety and the tolerability of UC-MSC     (Human Umbilical Cord-Derived Mesenchymal Stem Cell) .This study is also to investigate the     efficacy of this treatment in patients with Alzheimer's disease (AD).   "
132727|NCT01547676|"     This randomized pilot trial studies clamped or unclamped surgery in treating patients with     kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects   "
132728|NCT01547663|"     This study aims to test validity, reliability and practicality of translated NCS, CNPI and     FLACC in unconscious patients in 48 hour following craniotomy.   "
132729|NCT01547650|"     Rossi NF & Schrier RW reported that for having differential diagnosis in hyponatremic state,     it is important to have a grasp of extra cellular fluid (ECF) volume. However, recent works     showed that it is not easy to estimate the ECF state using by physical findings and by usual     laboratory methods.      Damaraju SC et al. first demonstrated that measuring central venous pressure (CVP) is     significant to evaluate the ECF state in hyponatremic patients with intracranial diseases.     Accordingly, it may be useful to measure the CVP in the hyponatremic patients. However,     usually it is difficult to measure the CVP in all patients with hyponatremia because that the     method is due to invasive procedure. With recently development, it is possible to estimate     the CVP calculation using cardiac echogram without invasion. However, it is not clear that an     evaluation by using such echogram estimates the state of ECF volume in hyponatremic patients.      Therefore, the investigators examine whether the CVP calculation by using cardiac echogram by     Marcelino P et al. method without invasion is estimated such condition in hyponatremic     patients before and after treatments.      As the primary endpoint, the VCI index values is investigated and compared with each group     before and after correction of disorders of fluid with sodium. Furthermore, some variables     including sodium, potassium, chloride, creatinine, BUN, uric acid, osmolality in blood and     urine and plasma vasopressin are investigated and compared with each group before and after     correction of disorders of fluid with sodium.   "
132730|NCT01547637|"     The key objective of this study is to compare success rates of ultrasound guided obturator     nerve block and anatomic landmark guided obturator nerve block as determined by     neuromonitoring endpoints and surgeon observations.   "
132731|NCT01547624|"     Today there is evidence for that neck specific exercises reduce neck pain problems in     patients with mechanical neck pain. However, there is a lack of consensus on how to optimize     neck exercises and dosages in neck rehabilitation. More knowledge is needed to determine     which and how muscles are activated in exercises thought to be neck-specific. There is     neither enough knowledge of differences in neck muscle activation between patients with long     standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle     function improved with specific neck exercises. One approach would be a real time study of     deformation and deformation rate in different layers of neck muscles in patients with     residual long-term neck pain and disability after a whiplash trauma. The purpose of the     present study was to investigate deformation and deformation rate in different layers of     dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during     rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion     until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder     elevation. Forty patients with long standing (more than 6 months but less than 3     years)patients and 40 controls matched for age and gender will be included for comparisons     between patients and healthy in neck muscle activation. The investigators also include 60     patients with whiplash trauma, of those 30 patients will be randomized to A. neck specific     exercises in a 3 months period and B. will 30 be on a waiting list for 3 months. Measurements     are performed at baseline and at 3 months follow-up. Those patients who fulfilled the 3     months period of neck specific exercises will also be asked for a 6 months follow-up.   "
132734|NCT01547585|"     This study is being conducted to test the hypothesis that daily consumption of a baked food     product containing whole soy for 6 weeks will significantly reduce plasma Low Density     Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall     goals of this study are to determine whether daily consumption of muffins made from whole soy     flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect     is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and     physical characterization of certified defatted whole soy flour that will be incorporated     into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a     control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy     muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical     trial. All participants will be randomized into one of three groups and asked to eat two     muffins daily for 6 weeks in the following combination: high dose soy; control group or low     dose soy. Before, after, and mid-way during the feeding period, blood samples will be     obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals.     The effect of soy consumption on waist circumference, body mass index (BMI) and blood     pressure will also be examined.   "
132735|NCT01547572|"     Since the introduction and favourable early results of enhanced recovery programmes more than     a decade ago, such programmes have become increasingly popular following major surgery. Many     elements of these programmes are based on solid evidence and derived from published trials.     These programmes optimize different factors to reduce the stress of surgery with the aim of     improving patient outcome and speed up recovery after surgery. Key factors prior to surgery     are conditioning of expectations and optimizing associated disease. Strategies during the     operation include use of short-acting anaesthetic (sleeping) agents, maintenance of normal     temperatures and minimal access surgery (keyhole surgery).      Care after surgery is optimized with appropriate analgesia (pain killers), early mobilisation     (walking) and early feeding. This combined approach reduces hospital stay to 2-4 days. There     is also evidence that the improvements resulting from the implementation of an enhanced     recovery programme do not cause significant deterioration in quality of life or transfer     costs to another component of health care.      The relative contribution of each of the single elements in the enhanced recovery programme     remains uncertain. Good patient information gives confidence and improves overall outcome. No     studies have examined the impact of video education on recovery.      The aim of this study is to explore the use of video information provision for patients     participating in an enhanced recovery programme.   "
132736|NCT01547559|"     We aim to evaluate the protective effects of eradication of HP and continue using     Geranylgeranylacetone (GGA) on NSAIDs related gastroenterological lesions. We further aim to     explore the effect of GGA on small-intestinal mucosal injuries induced by diclofenac sodium     in patients with rheumatic diseases who didn't take NSAIDs in the preceding 6 months.   "
132737|NCT01547546|"     This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and     tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with     progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study.     Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.   "
132738|NCT01547533|"     The investigators propose to study the transfer of benznidazole into breastmilk from the     blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk     and blood samples will be obtained from these patients at given times after they take the     clinically indicated medication, and the concentrations in both matrices will be compared to     estimate degree of transfer, which in turn will be used to evaluate potential degree of     exposure of infants breastfed by these women. This study will help clarify safety of     continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.   "
132739|NCT01547520|"     Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and     analgesic effects, so its use may be helpful for patients receiving upper endoscopy.   "
132740|NCT01547507|"     The aim of this prospective, randomized study is to compare the performance, safety, and ease     of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System     and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults     with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to     receive one of the following closed suction systems endotracheal tubes:        1. AirWay Medix Closed Suction System        2. KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared          regarding the safety, performance and ease of use (usability).   "
132741|NCT01547494|"     The purpose of the study is to assess whether, in individuals with migraines, a low-fat,     vegan diet improves pain more effectively than a control supplement or a placebo. The     principal measures are pain as measured by Visual Analog Scale (VAS) and the change in     migraines frequency. The study duration is 36 weeks.   "
132742|NCT01547481|"     This proposal is focused on developing a reliable, valid, and reproducible imaging techniques     and statistical methodology for segregation of various forms of Parkinsonism from healthy     adults without Parkinsonism.   "
132743|NCT01547468|"     The purpose of this study is compare the rates of post-operative delirium between a group of     people receiving intravenous (IV) pain control after hip fracture surgery and a group of     people receiving a femoral nerve catheter for pain control. Post-operative delirium is     confusion that can happen after the deep sleep of anesthesia. AThe hypothesis is that the     group receiving the femoral nerve catheter for pain may have a lower incidence of delirium     than the group receiveing IV pain medication.   "
132744|NCT01547455|"     Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative     stress effects and stabilise plaque in some conditions. Some researches indicate loading dose     statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were     significantly decreased. The investigators hypothesis loading dose atorvastatin may attenuate     inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce postoperative     acute kidney injury in cardiac surgery.   "
132745|NCT01547442|"     The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia     Lens in the treatment of aphakia in children.   "
132746|NCT01547429|"     This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used     as a secondary implant to correct aphakia in adults.   "
132750|NCT01547377|"     The aim of this randomized double-blind study was to evaluate the effect of oral zinc and     selenium supplementation on oxidative stress and inflammation biomarkers as well as the     status of zinc and selenium in patients with atherosclerosis and angina stable treated with     rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs     zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and     selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and     anti-inflammatory as well as the status of minerals?   "
132751|NCT01547364|"     Objective: The purposes of the study are to        1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in          comparison to normal saline.        2. Determine if cumulative benefit results from caudal dextrose injection.        3. Evaluate accuracy of a small needle vertical approach caudal injection that will allow          for blind injection of D5W.   "
132752|NCT01547351|"     This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in     clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general     neurology practices, or other academic or private practice settings) in the United States to     assess the psychometric properties of the ARMS questionnaire in approximately 100 adult     patients with MS who are experiencing a confirmed relapse, as identified by the investigator     or designee at each site. Neither efficacy nor safety of treatment will be evaluated in this     study.      The ARMS questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1     page. Part 1 is designed to evaluate the patient's relapse symptoms and how the symptoms     affect daily activities and overall function, as well as patient's response to past     treatments for previous relapses, as a means of guiding treatment selection. Part 2 is     designed to evaluate treatment response in terms of symptom relief and functioning, as well     as treatment tolerability. Part 1 of the survey is to be completed when the patient presents     with new relapse of MS. Part 2 of the survey is to be completed 1 month (± 1 week) after     initiation of treatment for relapse of MS. Treatment for relapse will be at the sole     discretion of the investigator.   "
132753|NCT01547338|"     Current qualitative methods of assessing the aesthetic result following breast reconstruction     are known to be poor.      The investigators believe that real time digital video footage followed by expert panel     review would be a superior method of qualitative assessment of breast cancer reconstruction     aesthetics. This has never been studied before.   "
132754|NCT01547325|"     The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo     Hydrogel on Dehisced Surgical Wounds.   "
132755|NCT01547312|"     This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA)     as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of     Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C     virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that     is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot,     core needle biopsy (CNB) will be performed on participants as part of their standard of care,     but no study drugs will be administered, nor will any procedures other than FNA be conducted.     The second segment, the main study, is designed to evaluate the feasibility of measuring     Grazoprevir by FNA. During the main study, drugs will be administered, and other additional     procedures will be conducted.   "
132756|NCT01547299|"     The purpose of this study is to determine if enzalutamide is an effective therapy in treating     localized prostate cancer prior to prostatectomy.   "
132757|NCT01547286|"     Asthma is a disease of rapidly increasing incidence that already affects more than 17 million     people in the United States alone. It has long been known that areas of severely reduced     airflow occur in asthma and contribute significantly to the impairment of gas exchange in     this disease. However, the extent to which local blood flow changes during an asthmatic     attack is unclear. The purpose of this study is using Positron Emission Tomography - Computed     Tomography imaging to evaluate how the blood flow changes in the lungs during an asthma     attack induced by allergens.   "
132758|NCT01547273|"     The purpose of this investigator-initiated study is to evaluate the facial gingival profile     following immediate implant placement and provisionalization in conjunction with connective     tissue graft with or without bone graft   "
132759|NCT01547260|"     The purpose of this study is to ascertain whether treatment with lenalidomide or lenalidomide     in combination with gemcitabine induces modulation of immune effector functions and to     characterize the nature of immune functions.   "
132760|NCT01547247|"     Water immersion insertion has been documented to decrease procedure-related discomfort during     colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal     intubation time. The investigators would like to assess whether combination of cap-fitted     colonoscopy and water immersion insertion is feasible and safe method of diagnostic     colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that     the use of cap is able to shorten it significantly. Patient comfort during colonoscope     insertion, water consumption, length of the scope while reaching the cecum, need for external     compression, need for positioning of the patient and endoscopist´s difficulty with     colonoscopy are assessed.   "
132771|NCT01547104|"     The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison     to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism     and oxidative stress in type 2 diabetic patients on stable control with metformin.   "
132772|NCT01547091|"     Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic     inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the     destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis     is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects     and thus potentially alleviates the progression of rheumatoid arthritis. The study is to     explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid     arthritis.   "
132785|NCT01546922|"     The aim of this study is to investigate whether a physiologically low hydrocortisone (HC)     dose is better for cognition as compared to a physiologically high HC dose. In addition,     quality of life, metabolic profile and somatosensation will be described in relation to HC     dose.   "
132761|NCT01547234|"     Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young     adults, with onset usually at age 20-40 years. Women are affected 3-4 times more than men.     The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.      Several immunotherapies were developed in the last 10-15 years for the long term management     of the relapsing type of disease. Treatment with these drugs decreases disease activity     though cannot cure it.      There are few treatments for targeting specific symptoms of MS, such as Provigil for the     treatment of fatigue.      Regarding problems related to spasticity and related gait problems , which is stated by over     40 % of MS patients as their main complaint - present treatments include: non-pharmacological     treatments such as physiotherapy, occupational therapy, hydrotherapy and pharmacological     treatments such as Baclofen, Tizanidine and Botulinium toxin.      Fampyra (Fampridine) has recently been approved for use in patients with gait problems. This     drug acts by blocking potassium ion channels and has been proven to improve walking in 35% of     the patients after one month of treatment.      The effect of Fampyra on hand function in MS has yet to be studied. The aim of this research     project is to assess the effect of treatment with Fampyra on manual function of patients with     MS. The investigators hypothesize that through the same mechanism by which Fampyra improves     ambulation it can also improve manual function.      MS patients visiting the MS center clinic at the Carmel Medical Center, with walking     disabilities eligible to Fampyra treatment, that have also manual dysfunction, will be     offered to participate in this study. Participants who agree to participate will be asked to     sign a written informed consent. Information regarding their personal and family medical     history will be collected via questionnaires. Medical staff will fill clinical questionnaires     detailing patient clinical status prior to the study.      Patients will be followed up to 4 months after initiation of treatment with Fampyra.     Compliance to treatment will be assessed by collection of the empty vials of the medication.      In each of the follow-up meetings evaluation of manual function, evaluation of ambulation and     evaluation of general neurological function will be performed.   "
132762|NCT01547221|"     Otomycosis is a superficial fungal infection of the external ear canal. Patients should be     treated with cleaning fungal debris combined with topical antifungal agent. There is wide     range of topical antifungal agents. However, there is still no consensus of the most     effective topical antifungal agents in treatment otomycosis is still lacking.      According to Thai National List of essential medicines for topical antifugal agents are:        -  acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)        -  boric acid (3% in isopropyl alcohol)        -  gentian violet        -  clotrimazole ear drop. But from literature review, there is no comparative study between          boric acid and clotrimazole solution before.      Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole     solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.   "
132763|NCT01547208|"     The purpose of this study is to assess whether the burden of untreated non-sustained     ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates     with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if     the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.   "
132764|NCT01547195|"     The recent scientific evidence shows that FM patients improve exercise capacity, symptoms and     quality of life with the holding of regular exercise, especially aerobic exercise. Swimming     is an aerobic workout of low impact, but no study has evaluated the effect of this activity     in patients with fibromyalgia.      Randomized controlled trial with blinded evaluator, which will be evaluated patients with     fibromyalgia were divided into two groups.      The intervention group will hold an exercise program of swimming (freestyle) and the other     considered the control group held a walking program.   "
132765|NCT01547182|"     The aim is to study the effects of weight loss and weight loss combined with different types     of physical activity on changes in physical functioning of older adults who are at-risk for     cardiovascular disease.   "
132766|NCT01547169|"     The study will examine the effects of intranasally administered long-acting insulin detemir     on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment     (aMCI). The rationale for these studies is derived from growing evidence that insulin     contributes to multiple brain functions, and that insulin dysregulation can contribute to AD     pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have     beneficial effects on brain function. Intranasal administration of insulin increases insulin     signaling in brain without raising peripheral levels and causing hypoglycemia. Insulin     detemir is an insulin analogue that may have better action in brain than other insulin     formulations because of its albumin binding properties. The investigators will test the     therapeutic effects of intranasally-administered insulin detemir in a dose-finding study in     which participants will receive one of two doses of insulin detemir or placebo for a three     week period. The investigators will test the hypothesis that either dose will improve memory     and daily functioning in persons with AD/aMCI compared with placebo.   "
132767|NCT01547156|"     Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of     diabetes and hypertensive patients by introducing a remote patient monitoring system     supported with automatic patient decision support. The feedback system is coupled with     back-office health coaching.   "
132768|NCT01547143|"     The investigators would like to propose a pilot study evaluating the efficacy of etoposide     combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis     (HLH), in order to prove out whether the modification of previous HLH-94 or HLH-2004 protocol     for childhood patients can improve the outcome and decrease the toxicities. The results of     this pilot study will be a base of a more-improved phase-2 protocol.   "
132769|NCT01547130|"     A quality colonoscopy examination remains as the gold standard for colorectal cancer     screening, but effective large bowel cleansing prior to colonoscopy is still not achieved in     all cases that undergo the procedure. Currently, the most widely used cleansing methods     employ balanced electrolyte-polyethylene glycol (PEG) solutions. However, a very large volume     of PEG solution is required for it to be effective, and many patients refuse to drink a     sufficient amount due to non-palatability. In this study, the investigators compare a novel     colon preparation method--bolus lukewarm saline with yoga exercise--with a PEG based solution     (HalfLytely) for large bowel cleansing.   "
132770|NCT01547117|"     Patients with POTS may not adequately expand their plasma volume in response to a high-sodium     diet. Mechanisms involved in the regulation of plasma volume, such as the     renin-angiotensin-aldosterone system and renal DA, may be impaired in POTS and may respond     inappropriately to changes in dietary sodium.The purpose of this study is to determine (1)     whether a high dietary sodium level appropriately expands plasma volume in POTS; (2) whether     plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium     in POTS; and (3) whether patients with POTS have improvements in their orthostatic     tachycardia and symptoms as a result of a high dietary sodium level.   "
132773|NCT01547078|"     A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in     patients with liver disease.   "
132775|NCT01547052|"     I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children     (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60     children in the comparison condition).      Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment     attendance, treatment satisfaction, and any differences in these rates by groups.      Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly     greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.      Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and     externalizing symptoms.      Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer     internalizing and externalizing symptoms.      Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation,     risk taking, and social skills, and reducing depression.      Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly     greater improvement in adaptive coping skills, emotion regulation, risk taking and     impulsivity and social skills, and reducing depressive symptoms.      Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.      Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer     critical incidents, including psychiatric hospitalization, emergency room visits, total     number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting     out, running away, stealing, police involvement, etc.      II: Finalize therapist training manuals and educational materials to guide selection,     training, and supervision of treatment providers.   "
132776|NCT01547039|"     The purpose of this study is to analyze the association between aspirin efficacy and general     platelet reactivity in relation to microembolic signals (MES) during carotid endarterectomy     (CEA).   "
132777|NCT01547026|"     Patients who suffer from diseases of the schizophrenia spectrum are frequently burdened by     weight gain. Sport programs have been shown to improve somatic and psychological health.     However, the motivation to participate in sports therapy is usually impaired due to     illness-related factors such as anhedonia and negative symptoms. Previous attempts to     increase participation in sports therapy have used psycho-educational and behavioral attempts     that require a lot of resources. In this study the investigators will use a brief method     developed in experimental social psychology to build up implementation intentions. This     method has been shown to improve psychological test performance in schizophrenia patients but     has never been used in a clinical context.      In two psychiatric hospitals, in-patients with schizophrenia who have been examined by a     medical doctor, for whom any medical concerns for sports therapy participation have been     excluded and who declared their motivation to participate in an existing standard sports     exercise program will be recruited for the study. After information on the study and signing     of an informed consent patients will be randomly assigned to two treatment conditions. In the     control condition, the main therapist will individually deliver a 10-minute psycho-education     on the helpfulness of sports to improve the health; this will be repeated in a shorter form     in the regular individual treatment sessions over the following weeks. The intervention     condition will use a structured procedure of the same duration to build up implementation     intentions to participate in the sports therapy. The implementation intentions will briefly     be repeated and updated in the following session.      Primary outcome variables will be percentage of attended sport therapy sessions, persistence     and compliance. Secondary outcome variables will be Body Mass Index. As confounding variables     the investigators will assess amount of anti-psychotic medication in Chlorpromazine     equivalents, negative and depressive symptoms, usual sport activities and cognitive     impairments.      The investigators expect that building up implementation intentions will increase     participation, persistence and compliance of the patients in the sports and exercise therapy     program compared to the patients who just have received psycho-education.   "
132778|NCT01547013|"     This is a study intended to evaluate a new device that uses light to measure the amount of     oxygen in the muscles of injured and non-injured legs and forearms in specific situations.     The name of this technology is NIRS (near-infrared spectroscopy). This is a prospective     observational cohort study intended to gather data using NIRS among injured and noninjured     extremities over time. Additionally, this data will help in establishing diagnostic perfusion     value thresholds to be used in a subsequent interventional study confirming the efficacy of     NIRS-based ACS monitoring.   "
132779|NCT01547000|"     The goal of this pilot study is to obtain preliminary information on the tolerability and     efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette     Disorder (TD, also called Tourette syndrome).   "
132780|NCT01546987|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid     17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of     androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells.     This may be an effective treatment for prostate cancer when combined with hormone therapy.     Studying quality-of-life in patients having cancer treatment may help identify the     intermediate- and long-term effects of treatment on patients with prostate cancer.      PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including     TAK-700, together with radiation therapy in treating patients with prostate cancer.   "
132781|NCT01546974|"     The purpose of this study is to determine which humidification system is more effective in     preventing pneumonia in mechanically ventilated patients. The study will compare a heat and     moisture exchanger versus heated humidification.   "
132782|NCT01546961|"     For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body     of evidence suggesting that pregnant women may require different doses of drugs, including     antimalarials due to the physiological changes of pregnancy. It is important that any drug     used in pregnant women it is given at the correct dose. The only way to evaluate this is by     pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of     chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same     evaluation in the same woman post-partum is required as a control.   "
132783|NCT01546948|"     The primary aim of this randomized, double-blind study is to examine the effect of a single     intraoperative dose of methadone on analgesic requirements during the first three days after     hepatobiliary or foregut surgery. These patients will be compared to subjects receiving a     standard dose of the traditional intraoperative opioid (hydromorphone). Secondary outcome     measures to be assessed will include postoperative pain scores and standard recovery     variables such as hospital length of stay.   "
132784|NCT01546935|"     Currently, there is no treatment for children less than one year of age with influenza     related lower respiratory tract infection that is either considered standard or registered in     any country. This dismal scenario exists even though influenza related LRTI is a significant     illness causing morbidity and mortality, especially in children less than 6 months of age.     Avian influenza has been reported rarely in children less than one.      There are no data in Vietnam and very few data in Thailand on the burden of influenza in     children less than one. This young age group suffers high mortality. Oseltamivir may be     beneficial in such children. This is basis of this trial.   "
132786|NCT01546909|"     PRIMARY OBJECTIVES        -  To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or          DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and          poliovirus types 1, 2 and 3        -  To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses          against diphtheria, tetanus, and poliovirus types 1, 2 and 3      SECONDARY OBJECTIVES        -  To describe other parameters of the antibody persistence against diphtheria, tetanus and          poliomyelitis antigens        -  To describe other parameters of the immune responses to diphtheria, tetanus and          poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE        -  To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE   "
132787|NCT01546896|"     This research aims to investigate the efficacy and safety of buspirone in treating     generalized anxiety disorder with depressive symptoms and to evaluate its neuroprotective     effects using magnetic resonance imaging.   "
132788|NCT01546883|"     This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an     anti-coagulant for a period of one year to see if there are any significant changes in the     degree of left atrial structural remodeling in these patients. The investigators hypothesize     that there will be a significant decrease in the degree of left atrial structural remodeling     (fibrosis) in AF patients treated with dabigatran.   "
132789|NCT01546870|"     Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality     in pediatric heart transplantation (PHT). Understanding the pathophysiology and early     detection along with attempted medical management are crucial in preventing advancement of     the disease and retransplantation or mortality. Coronary angiogram, although routinely used     is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary     flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and     flow intracoronary wire may be more sensitive in evaluating the integrity of coronary     vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge,     measurement of these parameters has not been previously reported in PHT.   "
132790|NCT01546857|"     This study is being done to determine if a drug called gabapentin helps in the postoperative     management of patients undergoing hip and knee operations. The investigators wish to     determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a     patient's pain and improve sleep, the patient will be better able to participate in their     physical therapy. Gabapentin has already been shown to lessen postoperative pain when given     before surgery. In healthy patients, it has also been shown to improve certain aspects of     sleep. We hope to identify the effect of the drug, when given after surgery, on patients'     pain and sleep.   "
132791|NCT01546844|"     This purpose of this is study is to evaluate the effectiveness of an interactive mobile     health information service, Care4Life, in supporting patient self-management of Type II     Diabetes Mellitus.   "
132792|NCT01546818|"     The purpose of this study is to examine the safety, tolerability, and immune response to     killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected     individuals.   "
132793|NCT01546805|"     The purpose of this study is to determine whether zinc supplements are effective in enhancing     the treatment of oculofacial spasm disorders with botulinum toxin.   "
132794|NCT01546792|"     Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by     interrupted breathing while sleeping. It is associated with cardiovascular problems such as     high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are     overweight and have impaired quality of life. Lifestyle interventions incorporating exercise     training, dietary advice and behaviour change have been shown to elicit favourable changes in     quality of life, body mass/composition and cardiovascular risk in a range of patient groups.     However, no study has investigated the impact of lifestyle modification on such health     outcomes in patients with OSAHS. This study will address this issue by investigating the     effects of a lifestyle intervention on quality of life, body mass/composition and     cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and     randomly allocated to one of the two groups. Patients in the intervention group will be     offered a 12-week individualised lifestyle programme consisting of supervised exercise     training, dietary advice and behaviour change counselling. Patients in the control group will     receive an educational booklet detailing healthy eating and exercise guidelines but no     supervised or structured intervention. The results of this study will inform the design of a     larger, multi-centre randomised controlled trial.   "
132795|NCT01546779|"     Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing     strategies, to clear secretions from their lungs. Hand held devices may aid mucus     expectoration, and also motivate the patient to manage by themselves. Our aims was to study     if resistive expiration through volumetric incentive spirometer (VISex) can improve lung     function in the short term in Cystic Fibrosis (CF) patients.   "
132796|NCT01546766|"     The basic objective of this project is to test a modification of existing technology for     monitoring the responses of the pupil to light as a method for detecting regional losses of     function of the retina. The instrument consists of a commercially available set of goggles     that monitor the eye positions and pupils using infrared light and small cameras. The signals     from the monitoring cameras are collected in a computer that records how their pupils have     responded to each lighting condition. Because diabetics develop damage initially to certain     parts of the retina before they have more serious damage, the ultimate goal of this research     is to develop a simple, noninvasive, rapid method for widespread screening of diabetics in     order to identify those who may require medical attention and/or therapy for diabetic     retinopathy.   "
132797|NCT01546753|"     The purpose of this study is to determine if walnut oral immunotherapy can be used in     subjects allergic to tree nuts to reduce tree nut allergy and induce changes in the subject's     immune system.   "
132798|NCT01546740|"     there is a variety of glaucoma prevalence within different populations. this study examine     the prevalence of glaucoma in the Arab population in Israel' as well as the demographic     variables and the compliance to treatment in the population.   "
132868|NCT01545804|"     This is a single-arm, open-label phase II trial. Eligible patients must have histological or     clinical diagnosis of Hepatocellular Carcinoma (HCC), advanced tumors that are not amenable     to loco-regional therapy, documented progression with or intolerance to sorafenib-based     treatment or other anti-angiogenic therapy as first-line therapy for advanced HCC.   "
132799|NCT01546727|"     This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic     and home family behavioral intervention (LAUNCH) against 1) motivational interviewing     (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168     children ages 2 to 5 years who meet the criteria for obesity (>95th percentile for body mass     index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI)     or standard of care. The primary end-point will be change in BMI z-score at the end of     treatment. The investigators will also assess maintenance of treatment gains at 6 and 12     months after treatment, and changes in factors thought to be mechanisms for change in weight     (food intake and activity level), changes in the obesiogenic environment (parent weight, food     intake and activity, and changes in the home food environment) and factors that could be     negatively impacted (parent and child eating and feeding interactions).   "
132800|NCT01546714|"     The purpose of this study is to determine rates of sexually transmitted infections (STIs)     among African American women who have sex with women (AAWSW). In addition, the study is     interested in better understanding the types of risk behaviors that place AAWSW at risk for     STIs. The investigators hypothesis is that AAWSW experience high rates of STIs, similar to     heterosexual African American women. Knowledge gained from this study will guide development     of interventions to reduce women's risk for these types of infections and will improve how     AAWSW are screened for STIs.   "
132801|NCT01546701|"     The purpose of this study is to determine whether sublingual Buprenorphine is as effective as     Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency     department.   "
132802|NCT01546688|"     A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide     arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be     administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).   "
132803|NCT01546675|"     The purpose of this pilot study was to conduct a head-to-head comparison of two designs for     transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket     design hypothesized to provide greater skeletal stabilization. The investigators comparisons     included assessments of patient comfort and satisfaction with fit, as well as dynamic     kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel     high-speed, high-resolution, bi-plane video radiography system.   "
132804|NCT01546662|"     The study will be conducted in two phases. First phase will be 16 weeks study to assess the     safety, efficacy & to determine the most appropriate dose. Will consist of following visits.      Phase II (Extended Follow-up): At the end of Day 112, an interim analysis will be conducted     to assess the sustained efficacy of the investigational product and accordingly the study     will enter into phase II.   "
132805|NCT01546649|"     Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated     against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal     breast cancer   "
132806|NCT01546636|"     The aim of this clinical investigation is to determine the effect of intraoperative     ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder     surgery in the beach chair position (BCP)   "
132807|NCT01546623|"     The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and     efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously     treated with hormonal therapy.   "
132808|NCT01546610|"     The present study aims to evaluate the effect of insoles for foot arthritis.   "
132809|NCT01546597|"     The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady     state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).   "
132810|NCT01546571|"     The purpose of this study is to determine how safe and how well POL-103A works in preventing     the relapse of melanoma after patients who have undergone surgery.   "
132811|NCT01546558|"     The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on     the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus     (T2DM).   "
132812|NCT01546545|"     This study is designed to determine whether a person's sensitivity to their own insulin     varies from the morning to the evening.   "
132813|NCT01546532|"     This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with     chronic heart failure. In addition safety and effects on renal function and biomarkers will     be assessed.   "
132814|NCT01546519|"     This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the     pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies     (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or     for whom no standard therapy exists.   "
132815|NCT01546506|"     Rationale:      Classical antiviral therapies target viral proteins and are consequently subject to     resistance. To counteract this limitation, alternative strategies have been developed that     target cellular factors. We hypothesized that such an approach could also be useful to     identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral     diversity and because of the need to develop therapies against unpredictable viruses as     recently underlined by the H1N1 pandemic. Gene-expression signature-based screening     identified broadly effective influenza A antivirals. Midodrine showed great results in     inhibiting viral growth and was the most suited to confirm its efficacy in vivo.      The main objective of the study is to assess the efficacy of midodrine taken at usual     recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus     Influenza A.      Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3     5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as     the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of     midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic     of viral replication; analysis of the frequency of emergence of mutants and associated     resistance.      Methods:      This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years     infected by influenza A virus. Nasopharyngeal washing will be performed at day 0     (randomization), 2, 3, 5 to show the viral replication evolution.      161 patients will be randomized as follows :        -  Arm 1 : Midodrine, 2.5 mg, 3 times a day        -  Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon          area.   "
132816|NCT01546493|"     Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause     of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics     and joint degradation to better identify 'at-risk' patients requiring corrective surgery will     be scrutinized to gain a better understanding of the condition's natural history. The     influence of certain morphologies (e.g. size and location of the deformity) will be analyzed     to determine if this leads to aberrant loading of regions of the cartilage and subchondral     bone, resulting in cartilage damage and joint degradation. Additionally, this research will     determine if changes in the subchondral bone precede cartilage degeneration.      The methodology for establishing the morphology/cartilage degeneration relationship includes     Magnetic Resonance Image (MRI) analysis, three-dimensional motion analysis and computer     simulation/finite element analysis.      The outcomes of this research may lead to a reduction in total hip replacement cases by as     much as 70%, saving many Canadians from a painful and debilitating condition and reducing     costs to the Canadian health care system by as much as $290 million annually.   "
132817|NCT01546480|"     Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to     persisting inflammation.      The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod     at patients 12 months after the operation.      DNA-samples are collected to examine genetical factors, important for perception of pain, and     the development of chronic pain.   "
132818|NCT01546467|"     The purpose of the study is to investigate the effect of a 30 hour cognitive remediation     program for young patients with early phase schizophrenia spectrum disorders on cognitive,     clinical and functional outcome measures. The remediation program is integrated with whatever     active rehabilitation the participant is currently attending (school, work, day program etc).   "
132819|NCT01546454|"     Women who have regular menstrual cycles have a lower risk of heart disease than men of the     same age or women who no longer have menstrual cycles. The purpose of this study is to help     determine why the menstrual cycle causes a lower risk of heart disease. The investigators     believe that the hormones (estradiol and progesterone) produced during the menstrual cycle,     as well as the normal processes occurring in the follicle and corpus luteum (transformed     follicle), change levels of good and bad cholesterol in the blood-stream. These levels of     good and bad cholesterol are an important risk factor for heart disease. Therefore, our goal     is to determine what effects each of these factors (estradiol, progesterone, follicle, corpus     luteum) have on the levels of good and bad cholesterol in the woman's bloodstream. As many     women take birth control pills, which contain synthetic forms of estradiol and progesterone     that block ovulation and development of a corpus luteum, the investigators also want to     determine what effect one common type of birth control pill has on levels of good and bad     cholesterol.   "
132820|NCT01546441|"     The IMPACT Plus Integrated Complex Care Clinic will create a team model of simultaneous     interprofessional consultation and planning that brings together patients with complex or     multiple chronic diseases, significant others/caregivers, the primary care team, community     care providers and, uniquely, secondary consultation in real time at the primary care site.     The purpose of this study is to evaluate whether the IMPACT clinic will reduce admission to     hospital and visits to the emergency department (ED) in comparison to a control (usual care)     group during a one year period of observation. Chart audits will be conducted on a monthly     basis to calculate patients' complexity scores and data on all health services provided     during the intervention phase, and compared between the intervention and control group.     Additionally, surveys and semi-structured interviews aimed to measure patient, caregiver, and     healthcare professional satisfaction of the IMPACT+ prior to and after initial assessment     will be collected.   "
132821|NCT01546428|"     INC280 will be administered to Japanese patients with advanced soid tumors whose disease has     progressed despite standard therapy or for whom no standard therapy exists. The trial will     assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280   "
132822|NCT01546415|"     The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with     Iron Overload and Aplastic Anemia.   "
132823|NCT01546402|"     This study is undertaken to determine the effect of intravitreal long acting dexamethasone     implant, (Ozurdex®) in improving outcome of cataract surgery in patients with diabetic     macular edema.      Diabetic Macular Edema and cataract constitute important causes of visual impairment in     patients with diabetes. Cataract surgery in patients with diabetic retinopathy is associated     with progression of retinopathy.      Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase     inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with     internal limiting membrane peeling have been tried for managing inflammatory cystoid macular     edema.      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to     reduce the retinal thickness and improve the visual acuity. However, recurrence of macular     edema in patients who receive intravitreal TA is a major concern as the patients need     multiple repeat injections.      In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug     Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently     developed. Promising results have been shown in certain patients with persistent diabetic     macular edema receiving this intravitreal drug delivery system with improvement in visual     acuity      The present study introduces a novel concept of using intraoperative Ozurdex ® implant in     patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening     of diabetic maculopathy.   "
132824|NCT01546389|"     This study will randomize 30 healthy adult participants to one of three cohorts comprised of     six groups of 5 individuals per group to simultaneously receive PfSPZ Challenge via the ID     route. The goal will be to determine the optimal dose required to achieve 100% infectivity     (ID100) of adult volunteers with P. falciparum malaria.   "
132825|NCT01546376|"     Objectives: To study immunostatus (CD4) and HIV viral load in HIV-cancer patients before RT     and last weeks of RT .   "
132826|NCT01546363|"     The purpose of this study is to measure the levels of serum proteins and other biomarkers in     cervical cancer patients. We believe that some of these markers may be useful in selecting     patients for specific types of cancer therapies. These markers may also help to predict     response to therapy, relapse after therapy, and survival after therapy.   "
132827|NCT01546350|"     The investigators propose to perform a clinical randomized trial to evaluate the effect of     single embryo (blastocyst) transfer (SET) with array CGH for the evaluation of the complete     chromosome complement of the blastocyst in comparison to standard ART methods in which one or     more embryo are replaced. Patients will be randomized into two groups:        -  Control group: patients will have up to two embryos replaced on day 5 based on          morphological and developmental characteristics, and the other embryos reaching          blastocyst stage will be vitrified. If patients in the control group do not have a          pregnancy to term from that fresh cycle, they will be offered free PGD either for the          frozen embryos of that cycle or for the next cycle (up to the center and patient). Data          from that PGD is not part of the study.        -  Test group: patients will have grade A,B or C blastocysts hatched on day 5, biopsied on          day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any          morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but          vitrified for use in a future cycle.   "
132828|NCT01546337|"     Anemia is common among cancer patients and the treatment of choice is now     Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment.     The purpose of this study is to evaluate the predictive value of endogenous erythropoietin     rate on the response to erythropoietin beta. First, by confirming the predictive value of     endogenous erythropoietin observed / predicted ratio on this response. Then if it is     confirmed by establishing the optimal value of this ratio.   "
132829|NCT01546324|"     The purpose of this study is to collect blood samples from pregnant women who achieved     pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy     screening (with or without single gene gene testing). These samples will be used for test     development of non-invasive prenatal diagnostic testing.   "
132830|NCT01546311|"     The primary objective of this study is to assess the effectiveness of the pro-active dynamic     socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees     during ambulation and rest, addressing residual limb volume fluctuations with a controlled     flow bladder system.   "
132831|NCT01546298|"     This study hopes to improve the investigators understanding of how the immune system acts in     allergic contact dermatitis. In order to reach this goal, normal volunteers, who are     suspected of having allergic contact dermatitis, will be patch tested for the fifteen most     common allergens. Then, biopsies will be taken of the skin at the sites where the there is a     positive reaction to the allergen. Also, small biopsies will be taken from an area that     received a patch but no allergen and an area that did not receive a patch to serve as     controls. In a second stage of the study, volunteers will receive patches with the allergen     to which they demonstrated an allergic response. More biopsies will be taken, over three     designated time points. The biopsied skin samples will then be studied in a laboratory.   "
132832|NCT01546285|"     The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient     Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.   "
132833|NCT01546272|"     A surgery made by an external incision requires to stitch the subcutaneous plans, usually     performed using absorbable synthetic sutures hold on wire needle. This national, prospective,     multicentric, and randomized study is devoted to estimate a technique of suture of the     subcutaneous plans based on an implantable medical device delivering automatically absorbable     staples. This particularly innovative technique lets to expect a tolerance and an efficiency     at least equivalent to the reference technique (main objective). Moreover, this technique     allows to anticipate a reduction of the duration of surgical procedure and anesthetic time     while limiting the risks of blood wounds of the medical staff.The medical economic part of     this study will check, from the point of view of the health care hospital, wether the     technique is likely to reduce the costs and time consuming theater room procedures.   "
132834|NCT01546259|"     Water method with water exchange has been shown to reduce medication requirement and pain     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion     of air from the colon during insertion by omission of air insufflations and suction removal     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy     insertion in average patients and may enhance the success of difficult colonoscopy.      Female gender and low-body mass index (BMI) is independently associated with incomplete     colonoscopy, respectively. The investigators postulate that low-BMI female patients may     benefit from using the water method for colonoscopy. In this proposal the investigators test     the hypothesis that compared with conventional air insufflations the water method with water     exchange significantly enhances the success rate of cecal intubation in low-BMI female     patients.      The aim of the study is to compare the outcome of colonoscopy using the water method versus     the conventional air method in low-BMI female patients. The primary outcome is cecal     intubation success rate. The secondary outcomes include cecal intubation time, maximum pain     score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.   "
132846|NCT01546103|"     The purpose of this research study is to determine whether taking vitamin D, every day, over     a 12 week period will improve the vitamin D status, risks for poor heart health, risks for     developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers     with low vitamin D levels.   "
132847|NCT01546090|"     The purpose of this prospective, randomized, double-blind, placebo-controlled study is to     evaluate the effect of preoperative administration of alprazolam on the success of the IAN     block for teeth with irreversible pulpitis.   "
132848|NCT01546077|"     The purpose of this study is to assess the efficacy of the hydrolocalization technique for     placement of popliteal perineural catheters in comparison with the stimulating catheters. A     non inferiority trial.   "
132849|NCT01546064|"     The purpose of this study was to compare the incidence and severity of biliary complications     due to liver transplantation after choledochocholedochostomy with or without a T-tube. A     per-protocol analysis was designed for recipients of orthotopic liver transplantation in a     single center, who were randomly assigned to choledochocholedochostomy with or without a     T-tube. It is a prospective and randomized study.   "
132850|NCT01546051|"     This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its     metabolite BCI-632 and several new pro-drugs in healthy male subjects.   "
132835|NCT01546246|"     Water method with water exchange has been shown to reduce medication requirement and pain     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion     of air from the colon during insertion by omission of air insufflations and suction removal     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy     insertion in average patients and may enhance the success of difficult colonoscopy.      Colonoscopy has been considered the gold standard procedure in screening for colorectal     disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult     anatomy and prior abdominal or pelvic surgery. The investigators postulate that these     patients may benefit from using the water method for colonoscopy. In this proposal the     investigators test the hypothesis that compared with conventional air insufflations the water     method with water exchange significantly enhances the success rate of cecal intubation in     patients with immediately failed colonoscopy.      The aim of the study is to compare the outcome of colonoscopy using the water method versus     the conventional air method in patients with incomplete colonoscopy. The primary outcome is     cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum     pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection     rate.   "
132836|NCT01546233|"     The purpose of this study is to compare the fatigue in lung cancer patients receiving     chemotherapy treatment, between the education programme in self-care a multidisciplinary with     the group who received standard care.   "
132837|NCT01546220|"     Water method with water exchange has been shown to reduce medication requirement and pain     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion     of air from the colon during insertion by omission of air insufflations and suction removal     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy     insertion in average patients and may enhance the success of difficult colonoscopy.      Older age is independently associated with incomplete colonoscopy, the investigators     postulate that these patients may benefit from using the water method for colonoscopy. In     this proposal the investigators test the hypothesis that compared with conventional air     insufflations the water method with water exchange significantly enhances the success rate of     cecal intubation in elder patients.      The aim of the study is to compare the outcome of colonoscopy using the water method versus     the conventional air method in elder patients. The primary outcome is cecal intubation     success rate. The secondary outcomes include cecal intubation time, maximum pain score during     colonoscopy, overall pain score after colonoscopy and adenoma detection rate.   "
132838|NCT01546207|"     The goal of this trial is to test the impact of a step-wise approach for catheter ablation of     recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom     chambers of the heart), in patients with a previous heart attack for whom catheter ablation     is clinically indicated.   "
132839|NCT01546194|"     In most current academic anesthesia groups, it appears that consent for research is acquired     on the day of surgery. This practice raises concerns because the hospital may be regarded as     a coercive environment and there may be the possibility that the immediate preoperative     environment prohibits adequate time for understanding the research project and making an     informed decision about participation. However, this is often the only opportunity for     anesthesiologists to obtain research consent. The aim of the present investigation is to     utilize a survey study to determine if patients at Evanston Hospital are comfortable     consenting for research on the day of surgery   "
132840|NCT01546181|"     Using an adaptive optics imaging device, retinal structures are observed in healthy and     diseased subjects.   "
132841|NCT01546168|"     In this randomized double-blind study, the investigators would like to compare standard     practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal     deviation during AF ablation. The investigators hypothesize that the strategy of esophageal     deviation will result in safer ablation strategy with a reduction in the incidence of     esophageal injury as assessed by endoscopy.   "
132842|NCT01546155|"     Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain     will alter the binding properties of ([11C]diprenorphine), a molecule that can be used during     brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI)     imaging will be used in this study.   "
132843|NCT01546142|"     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of     submental fat (fat below the chin).   "
132844|NCT01546129|"     Perineal massage at the end of labor stage 2 has been investigated in 2 randomized controlled     trials using a water soluble lubricant. In one trial a significant reduction of labor stage 2     has been found, both trials did not show a significant increase of perineum integrity.      In the HCB Swiss Study both a significant reduction of labor stage 2 by 30 % as well as a     significant increase of perineal integrity have been shown. No adverse events have been     reported.      (see also Obstetric gel shortens second stage of labor and prevents perineal trauma in     nulliparous women: a randomized controlled trial on labor facilitation. Schaub AF, Litschgi     M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. J Perinat Med 2008; 36 (2): 129-135).      Today's practice- Lubricants are widely used to enable manual vaginal examination during     labor. In Israel midwifes are using Almond Oil for perineal massage at the end of labor stage     2 to protect the perineum. It has been shown for the first time that the use of the Dianatal     Obstetric Gel facilitates vaginal childbirth in humans. Dianatal has been introduced to the     EU markets in 2008.   "
132845|NCT01546116|"     -  Entecavir has been one of the option for treatment of lamivudine resistant chronic          hepatitis B (CHB).        -  In case of entecavir resistance, adefovir could be used. However, sequential monotherapy          may result in multidrug resistance.        -  It is thought that adefovir and lamivudine combination therapy reduce the risk of          adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B          virus (HBV) DNA to be undetectable in patients with entecavir resistance.        -  This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy          in CHB patients with entecavir resistance.   "
132852|NCT01546025|"     This is a 2-year research project to test the efficacy of brief motivational intervention for     reducing heavy alcohol use in young adults transitioning out of high school. Participation     occurs within 3 months prior to graduation or within 1 year following graduation or dropout     from high school. Heavy drinkers ages 17-20 will be randomly assigned to receive one session     of BMI or one session of relaxation training. All participants complete identical assessments     at baseline and immediately post-intervention (during session 1). Participants also complete     in-person 6-week and 3-month follow up assessments to evaluate intervention effects. Study     aims involve: a) testing the comparative efficacy of BMI; b) identifying moderators     (person-level predictors) of intervention response; and c) identifying mediators (mechanisms)     of intervention effects, that is, how BMI exerts its effect on outcomes.   "
132853|NCT01546012|"     Assess the patient feeling about the handiness of two different vials used to deliver both,     unpreserved hyaluronic eye drops.   "
132854|NCT01545999|"     The purpose of this study is to        1. assess the effect of PAS in schizophrenia in the dorsolateral prefrontal cortex (DLPFC)        2. assess the effect of PAS induced long-term potentiation (LTP) on the performance of          patients with schizophrenia on a cognitive task related to DLFPC.   "
132855|NCT01545986|"     The purpose of this study was to compare the effects of two exercise programs, using low     velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have     undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals     performing HV exercise, compared to LV, would exhibit superior outcomes.   "
132856|NCT01545973|"     The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and     sweat gland density on Scanning Kelvin Probe measurements.   "
132857|NCT01545960|"     The purpose of this study is to characterize the surface electrical potential of acupuncture     points with a Scanning Kelvin Probe.   "
132858|NCT01545947|"     The main purpose of this first study combining an investigational dual mTOR inhibitor,     CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to     establish a maximum tolerated dose level for each combination in order to evaluate their     effects in future clinical trials for advanced non-small cell lung cancer.   "
132859|NCT01545934|"     The purpose of this study is to study the effects of a multicomponent lifestyle intervention     that includes partial meal replacements as a means to prevent excessive gestational weight     gain in obese women. The primary hypothesis is that the intervention will reduce the rate of     gestational weight gain compared with standard care.   "
132860|NCT01545921|"     The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated     to the end of life for French cancer patients.   "
132861|NCT01545908|"     Ulcerative colitis is a condition that mainly affects young adults where the lining of the     bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and     treatments remain imperfect with no cure for the disease. Initial success has been shown with     a highly novel treatment where patients with active ulcerative colitis receive a fecal enema     to try and replace their stool containing bacteria that may be driving their disease with     that from a healthy donor. To assess if this works by comparing how well it treats the     disease compared to a placebo enema.   "
132862|NCT01545882|"     This study is being offered to patients who have hormone resistant prostate cancer (HRPC).     This means that their prostate cancer is no longer responding to standard hormonal therapy.      The purpose of this study is to determine whether Degarelix will be able to stop the PSA from     rising in patients with hormone resistant prostate cancer.   "
132863|NCT01545869|"     Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and     sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a     fair complexion patient, but may be present in other skin types.      The gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles,     pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid     1990s. The traditional CO2 laser was very effective, however it fell out of favor because it     required general anesthesia. It also had a prolonged recovery time. Over the last several     years, advances in technology known as fractional resurfacing has made the CO2 laser popular     again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It     proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of     our knowledge, based on a thorough search of literature, no clinical studies assessing     fractional CO2 laser in treatment of freckles could be retrieved.   "
132864|NCT01545856|"     Cardiovascular (CV) disease is a common comorbidity of Parkinson's disease (PD). The     background incidence rate of CV events in a levodopa-treated PD population was assessed to     better understand these comorbidities in the PD population. One objective of the study is to     identify a population of prevalent PD patients with incident levodopa use within the years     2004-2010 on the Integrated Health Care Information Services (IHCIS) database. The second     objective is to report the incidence of CV events overall and during intervals 0-6, 6-12 and     12-18 months after first prescription of levodopa among all new levodopa users.   "
132865|NCT01545843|"     The purpose of the study is to determine whether changing sleep patterns improves response to     an antidepressant medication.   "
132866|NCT01545830|"     Vitamin D deficiency is widespread and appears to represent one easily and inexpensively     modifiable risk factor for diabetes and cardiovascular disease. More than 40 years of data     link hypovitaminosis D to metabolic syndrome, insulin resistance, hyperglycemia, type 2     diabetes and increased cardiovascular risk.      Screening for vitamin D deficiency followed by supplementation in appropriate individuals     could be among the simplest and most cost-effective measures for reducing metabolic syndrome     and insulin resistance in the general population.      This study will test the hypothesis that increasing vitamin D status in vitamin D deficient     individuals with metabolic syndrome will:        1. reduce multiple serum cardiometabolic risk factors for both diabetes and cardiovascular          disease,        2. stabilize or reverse the stage of pre-diabetes,        3. improve quality of life, and,        4. improve the ability to make health-related behavioral changes.   "
132867|NCT01545817|"     Study to determine the efficacy, safety and tolerability of first-line pazopanib followed by     second-line everolimus in metastatic and advanced renal cell carcinoma   "
132875|NCT01545713|"     Antibody Mediated Rejection (AMR) is a major complication of solid organ transplantation. The     main reason for AMR is pre-formed, or de-novo, donor specific antibodies against the donor     HLA antigens. Additional potential targets are antibodies against MIC-A antigens or     antibodies against targets expressed on the donor endothelial cells.      Until recently, no specific means were available to test for the presence of donor-specific     endothelial cell antibodies. The newly introduced XM-One AbSorber® assay allows isolating     precursor endothelial cells from donor peripheral blood, and thus assessing the presence of     donor-specific endothelial cell antibodies.      XM-One AbSorber® is an in-vitro assay that allows for the specific enrichment of precursor     endothelial cells which in turn promotes endothelial cells specific cross match testing.      This assay is currently being used in an on-going Northwestern University (NU) research study     (STU#00029988). The preliminary results of this study indicate that indeed some of the     patients test positive against their respective donors. One potential explanation for this     observation, that was not previously entertained, is that the antibodies causing the positive     cross match response are actually of autoimmune nature. In order to rule-out such a potential     explanation the investigators would like to further test these patients by performing an     autologous XM-One AbSorber® assay in which the recipient sera will be incubated with the     patients' own cells (as opposed to the respective donor cells in the parental study). This     information is crucial for proper analysis of the data obtained in the NU STU#00029988 study.   "
132876|NCT01545700|"     The question of a possible hyperglycemic effect from single-dose dexamethasone is an     important issue for clinicians managing patients in the intraoperative and postoperative     periods. Recent evidence suggests that even moderate elevations in blood glucose levels may     be associated with adverse events.      The aim of this clinical investigation is to determine whether standard clinical doses of     dexamethasone produce hyperglycemia in the perioperative period.   "
132877|NCT01545687|"     RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth     sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve the     quality of life of patients with head and neck cancer.      PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral     mucositis in patients with head and neck cancer who are being treated with cisplatin and     radiation therapy. These results will be compared to results in patients using placebo     lozenges.   "
132878|NCT01545674|"     This prospective blinded study will assess the diagnostic capability of an informatics     enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying     a fetus with an aneuploidy from fee floating DNA in the maternal blood.   "
132879|NCT01545661|"     This study will investigate the benefit of using Sputum induction for TB diagnosis in a     primary care clinic for adult TB suspects that are either unable to produce a sputum sample     (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (WHO     standard for frontline TB diagnosis). The investigators hypothesize that acquiring an induced     sputum sample for smear microscopy and liquid TB culture will decrease time-to-diagnosis and     time-to-treatment initiation in smear negative/sputum scarce TB patients in a primary care     clinic in a resource-limited high TB HIV prevalent setting.   "
132880|NCT01545648|"     The purpose of this study is to see whether taking denosumab for 12 months in women with a     significant number of disseminated tumor cells in the bone marrow can reduce the number of     these cells below a significant level.   "
132892|NCT01545492|"     INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled     trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP     (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in     pregnancy is better for the baby without increasing maternal risk.      CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to     non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing     and a maternal questionnaire about infant feeding practices and background]. Annual contact     will be maintained in years 2-5 and contact will include annual parental measurement of the     child's height, weight and waist circumference.      OBJECTIVE: To directly test, for the first time in humans, whether differential blood     pressure (BP) control in pregnancy has developmental programming effects, independent of     birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight')     control of maternal BP will be associated with fetal under-nutrition and effects will be     consistent with developmental programming.   "
132881|NCT01545635|"     Severe traumatized patients (ISS > 15) admitted to emergency department (ED) University     Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage     will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and     subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient     meets the inclusion criteria (T1) and is recruited for the study, a first study related blood     sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be     randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or     FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive     fresh frozen plasma (FFP),respectively.      Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve     after two times dosages of study drug. In these cases haemostatic rescue therapy will be     administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be     administered to patients randomized to receive FFP and FFP will be administered to patients     of the CFC group.      In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse     bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII     concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy     will be documented and a ROTEM will be performed thereafter.      At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related     blood samples are drawn (40mL each).      The indications for transfusion of red blood cells or platelets, administration of     antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement     are similar for both groups and treatment is performed according to clinical routine.      Besides coagulation management during ED treatment until 24h on ICU, patient's care is not     influenced by the study and follows clinical routine.   "
132919|NCT01545141|"     Determine the safety of a combination of IFN, celecoxib, and rintatolimod for patients with     recurrent colorectal cancer. This will also test whether the above combination can help the     immune system to fight the tumors. The results will allow the investigators to determine the     preferred combination for subsequent extended studies.   "
132920|NCT01544153|"     This study will compare the efficacy of an interactive, evidence-based smoking cessation     website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social     network (SN) protocol designed to integrate participants into the online community, and 2)     access to a 4-week supply of free NRT.   "
132921|NCT01544140|"     The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of     Midazolam administered alone and in combination with Vandetanib.   "
132883|NCT01545609|"     This study is a randomized controlled trial assessing the effectiveness in a series of     educational text messages in improving continuation of a birth control method in comparison     to the 'standard counseling', when girls initiate a new method of birth control. Girls aged     15-19 year olds who are attending for a reproductive health visit and who own a working cell     phone will be approached and asked if they would like to participate. Following completion of     a baseline questionnaire and consultation for initiation of a new birth control method they     will be randomized to receive either the intervention or standard counseling.      If randomized to the intervention they will receive 3 messages per week for the initial 3     weeks, 2 messages per week for the following 5 weeks and then one message per week     thereafter. Messages will be tailored to the birth control method the participant has     initiated. At 4 months all participants will be contacted via telephone and asked to complete     a questionnaire regarding continuation of use.   "
132884|NCT01545596|"     The objective of this study is to use a decision-support system combined with an electronic     anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) < 75     mmHg, and Bispectral Index (BIS) < 45) and generate alerts suggesting hemodynamic support.     Specifically, the project will test the hypothesis that providing Double Low alerts reduces     90-day mortality. Secondary outcomes will be the fraction of alerts that generate early     clinician responses, subsequent changes in MAP and hospital length of stay.   "
132885|NCT01545583|"     The purpose of this study is to investigate the safety and tolerability of LY3016859     administered as single doses, and to determine how long LY3016859 remains in the body   "
132886|NCT01545570|"     This is a single-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose     study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of     GSK2374697 in healthy volunteers. The study will enrol approximately 72 subjects at one     clinical study center in the United States.   "
132887|NCT01545557|"     The aim of this study is to assess performance and tolerance as well as investigator and     subject satisfaction further to pan-facial volume restoration with a new cross-linked     hyaluronic acid dermal filler containing lidocaine 0.3%.   "
132888|NCT01545544|"     An prospective / retrospective multicenter observational study whose objectives are to     understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The     characteristics , evolution and treatment of diseases will be observed from the study.   "
132889|NCT01545531|"     The purpose of this study is to measure glomerular filtration rate (GFR) by iohexol plasma     disappearance (gold standard) and measure serum Cystatin C levels (surrogate marker) in     patients enrolled in our prospective study at baseline, day 100 and 1 year after     hematopoietic cell transplant and determine if these levels correlate with serum creatinine     and an estimated GFR using the Modification of Diet in Renal Disease (MDRD) equation and     Schwartz formula in children.   "
132890|NCT01545518|"     The purpose of the initial screening study is to find out if immune problems are an     unrecognized cause of epilepsy in some patients. This study consists of a single blood     sample, which will be tested for possible immune abnormalities. If enough patients are found     who show immune abnormalities, those patients who are still having uncontrolled seizures will     be invited to participate in a study of immune treatment with a compound called intravenous     immunoglobulin (IVIG).      The study hypothesis is that a significant proportion of the young-onset, refractory,     image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and     many of these patients will respond to immune therapies, including IVIG.      At present, the importance of immune abnormalities in causing epilepsy, and the proper     treatment when they are found, are both poorly understood. The investigators hope that this     study will help us understand the cause of some cases that are difficult to treat.   "
132891|NCT01545505|"     Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors     predicting PTSD relapse are still unknown. The aim of this study is to examine whether     clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that     characterized PTSD can be observed in people with past PTSD (children and their families) and     whether these persistent changes are predictive of PTSD relapse.   "
132941|NCT01545128|"     The purpose of this study is to study the direct cost of illness study of COPD patients who     participated in a Pulmonary rehabilitation program for 8 weeks.   "
132893|NCT01545479|"     It is well established that renal hypoxia is associated with the development of renal injury.     The purpose of this study is measure the alterations in renal blood oxygenation after     angiotensin II converting enzyme inhibition. The understanding of kidney adaptive mechanisms     to renin angiotensin system effects in healthy subjects will be useful for the early     detection of renal disease and for the development of new therapies to decrease the     progression of the disease and its consequences.   "
132894|NCT01545466|"     This proposal describes a randomized controlled pilot trial investigating feasibility,     safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness     based stress reduction (MBSR) program compared to a wait-list control group.   "
132895|NCT01545453|"     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will     assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains     uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller     medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment     with subcutaneous lebrikizumab (highest, middle, lowest dose) or placebo every 4 weeks     for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a     52-week double-blind active treatment extension. The anticipated time on study treatment is     up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study     drug for all patients.   "
132896|NCT01545440|"     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will     assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains     uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller     medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment     with subcutaneous lebrikizumab (highest, middle, lowest dose) or placebo every 4 weeks     for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a     52-week double-blind active treatment extension. The anticipated time on study treatment is     up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study     drug for all patients.   "
132897|NCT01545427|"     The purpose of this study is to investigate the effectiveness and safety of the drug Gleevec     (imatinib) as a new treatment for patients with active diffuse scleroderma. This drug has not     been used previously to treat scleroderma, but it has been found to advance the treatment and     life span of patients with a type of leukemia called chronic myeloid leukemia or CML. Gleevec     acts on chemical signals in the cells that may decrease fibrosis (the hardening of the skin     that occurs in scleroderma). It works by interfering in the process that activates many     molecules that cause fibrosis, including TGFbeta (which may be a key part of disease activity     in scleroderma).      This study proposes to treat patients that have significant diffuse scleroderma with Gleevec     for 6 months and investigate several measures of scleroderma disease activity before, during     and at the end of treatment (0, 3 months and 6 months). This is a randomized, double blind,     placebo-controlled trial: 20 patients will be divided into two groups in a 4:1 ratio, with 16     patients taking 400mg of Gleevec per day and 4 taking a placebo. The differences between the     groups that will be measured include safety, Modified Rodnan skin score (mRSS), Health     Assessment Questionnaire (HAQ), global assessments (100mm VAS) and changes in biomarkers in     blood and skin biopsies.   "
132898|NCT01545414|"     The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral     Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety     symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment     (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to     SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that     ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.   "
132899|NCT01545401|"     BACKGROUND      Chronic disease management (CDM) presents enormous challenges to the primary care workforce     due to the rising epidemic of cardiovascular risk factors. The Chronic Care Model (CCM) was     proven effective in improving chronic disease outcomes in developed countries. Evidence that     this model works in developing countries is still scarce. Therefore, the aim of this study is     to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted CDM strategies     based on the CCM) in managing type 2 diabetes mellitus (T2DM) and hypertension (HPT), using     readily available resources in the Malaysian public primary care setting.      METHODS      This is a pragmatic cluster randomised controlled trial - participatory action research which     is currently being conducted in 10 public primary care clinics in Selangor and Kuala Lumpur,     Malaysia. Five clinics are randomly selected to provide the EMPOWER-PAR intervention for 1     year, while the other 5 clinics continued with usual care. Each clinic recruits consecutive     T2DM and HPT patients who fulfil the inclusion and exclusion criteria over a 2-week period.      The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary CDM Team;     and training the team to utilise the Global CV Risks Self-Management Booklet to support     patient care and reinforcing them to utilise relevant clinical practice guidelines to aid     management and prescribing.      For T2DM, primary outcome is the change in the proportion of patients achieving target HbA1c     of <6.5%. For HPT without T2DM, primary outcome is the change in the proportion of patients     achieving target blood pressure of <140/90 mmHg. Secondary outcomes include the proportion of     patients achieving targets serum lipid profile, body mass index and waist circumference.     Other outcome measures include medication adherence levels, process of care and prescribing     patterns. Patients' assessment of their chronic disease care, providers' perception, attitude     and perceived barriers in delivering the care and cost-effectiveness of the intervention are     also evaluated.      CONCLUSION      Results from this study will provide objective evidence of the effectiveness and     cost-effectiveness of a multifaceted intervention based on the CCM in resource constraint     public primary care setting. It is hoped that the evidence will instigate the much needed     primary care system change in Malaysia.   "
132900|NCT01545388|"     This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice     daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes     mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and     sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg     b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from     baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d.     is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in     HbA1c at 24 weeks.   "
132901|NCT01545375|"     The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis     media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine     GSK2189242A in Native American infants aged less than 24 months, living in the southwestern     US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the     impact on acute lower respiratory tract infections (ALRI) up to the second year of life.   "
132976|NCT01544673|"     Results from previous studies have been inconclusive and the effect of linezolid on cytokines     remains unclear. This study is designed to evaluate the effect of linezolid on the     functionality of white blood cells (neutrophils and monocytes) in healthy subjects.   "
132902|NCT01545362|"     To determine if preop nutritional status is an indicator for outcomes of bilateral staged     total knee arthroplasty. The investigators expect that patients having staged bilateral total     knee arthroplasty with the second procedure performed within one week of the first and have a     total lymphocyte count >1500 per cubic millimeter and serum albumin level >35 grams per liter     will have the same or less complications and shorter length of stay than those with lower     lymphocyte count and albumin level.   "
132903|NCT01545349|"     This is a Phase I, randomized controlled trial to evaluate the safety of Lactobacillus     rhamnosus GG (LGG) versus placebo in elderly subjects receiving the live attenuated influenza     vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several     strains of Lactobacilli that is used as a probiotic or microorganism administered to confer     health benefits. Our research is focused on studying the possible therapeutic effects of     LGG. The study hypotheses are:        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly          subjects who have just received the live attenuated influenza vaccine,        2. The immune response to the influenza vaccine at day 21, 28, and 56 will be higher in the          LGG group than the placebo group,        3. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, and          56 will be greater in the LGG group than the placebo group.   "
132904|NCT01545336|"     The main purpose of this clinical trial is to study the safety and efficacy of anastrozole in     adults diagnosed with pulmonary arterial hypertension (PAH). The study will evaluate how well     the drug is tolerated. The study will also evaluate if anastrozole effects estradiol (E2)     hormone levels, a sex hormone, and improves the function of the lower right chamber of the     heart (right ventricle).   "
132922|NCT01544127|"     The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to     Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically     hospitalized Veterans at high risk for suicide.   "
132923|NCT01544114|"     A 6 month study of VIMOVO in adolescents aged 12-16 years with juvenile idiopathic Arthritis     (JIA)   "
132905|NCT01545323|"     Netherton Syndrome is a serious skin disorder caused by damage in a gene called SPINK5. This     gene controls the formation of a protein called LEKTI, which important for skin barrier     function. LEKTI inhibits certain enzymes (serine proteinases) in the outermost layer of the     skin (epidermis). The function of the serine proteinases is to break down the intracellular     cement that holds together the horny cells in the epidermis, in order for the skin to be able     to shed cells (known as cell desquamation). LEKTI deficiency leads to an uninhibited     desquamation of horny cells, and as a result the skin becomes red and scaly. The barrier     function of the skin is also affected. The permeability of the skin increases, and its     capacity to bind water decreases, which causes dryness. The thinness of the barrier also     results in over absorption of chemicals, for example topical medical treatments. Historically     one in ten infants dies before their first birthday. Currently there are no proven treatments     to cure this condition.      The investigators have been developing a gene therapy approach to treat this disorder. The     investigators have used a disabled virus (vector) to carry a functional copy of the SPINK5     gene into skin stem cells. Proof-of-principle experiments have shown the investigators can     restore almost normal shape and size of the upper layer of the skin in skin grafts grown in     the lab. Even if only a small number of cells are genetically modified to carry the corrected     SPINK5 gene, there seems to be a correction over a wide area of the graft.      In this trial the investigators propose grafting of autologous epidermal sheets generated     from genetically modified skin stem cells for the treatment of patients with Netherton     Syndrome. The investigators anticipate production and release of LEKTI protein from even a     small patch of skin will be beneficial.   "
132906|NCT01545310|"     This open-label, Phase 1 study will investigate the 5-hydroxytryptamine 6 (5-HT6) receptor     occupancy in the brain using positron emission tomography (PET) following single oral doses     of SLV354. Up to 22 healthy male subjects and male subjects with stable schizophrenia,     between 18-55 years of age are to complete the study.   "
132907|NCT01545297|"     Awake craniotomy for resection of brain tumor located in close proximity to areas of eloquent     brain function, such as speech, motor and sensory, is an accepted procedure used to minimize     neurological injury during resection. During awake craniotomy, anesthesia is usually provided     using a combination of local anesthesia (regional scalp block and/or local infiltration) and     intravenous (IV) agents to provide sedation, anxiolysis and analgesia. Propofol sedation,     commonly in combination with a shorter acting opioid such as fentanyl, or remifentanil, is an     effective and popular technique during awake craniotomy, achieving a high degree of patient     satisfaction and acceptance. Most of the anesthetic agents are associated with some     respiratory depression.      The anesthetic agent called dexmedetomidine is a potent, highly selective α2-adrenoceptor     agonist. The effects of dexmedetomidine are anxiolysis, analgesia, sedation and     sympatholysis, and it is not associated with respiratory depressive effect. Bekker et al.     first reported the successful use of dexmedetomidine in awake craniotomy in 2001.      The purpose of this blinded, prospective, randomized study is to compare the efficacy of     dexmedetomidine versus propofol-remifentanil based sedation in patients undergoing awake     craniotomy for resection of tumors. The study hypothesis is that the efficacy of performing     intra-operative brain mapping is identical between dexmedetomidine and the     propofol-remifentanil based sedation. The primary end-points are to assess the ability to     perform intraoperative mapping during awake craniotomy. Secondary end-points will assess the     incidence of complications (respiratory depression, failure to provide adequate analgesia),     as well as patient and surgeon satisfaction to the corresponding anesthetic technique.   "
132908|NCT01545284|"     This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the     efficacy and safety of acitretin in patients with severe chronic hand dermatitis .   "
132909|NCT01545271|"     This study examines the effect of inhaled xenon gas in the treatment of newborn infants with     hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard     treatment for this condition. The hypothesis is that the xenon + cooling combination will     produce better neuroprotection than the standard treatment of cooling alone.   "
132910|NCT01545258|"     A commonly administered conservative non-pharmacological treatment for OA is exercise, with     beneficial effects in terms of reduced pain and disability.      While the link between exercise and reduced disability is mediated by e.g. increased muscle     strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA     patients have both peripheral and central sensitization of pain mechanisms resulting in     hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral     and central mechanisms but it unknown if exercise affects either of these mechanisms.      It is hypothesized that in knee OA patients exercise reduces the pain sensitivity   "
132911|NCT01545245|"     The primary objective of the study is to determine whether the incidence of atopic asthma     after three years old may be suppressed in the children who were born as preterm infants and     prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections     during the infancy.      The secondary objective is to determine whether the incidence of recurrent wheezing after     three years old may be suppressed in the children who were born as preterm infants and     prophylactically treated with palivizumab for RS virus infections during the infancy.   "
132912|NCT01545232|"     Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial     designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted     to receive massive transfusion ([MT] (defined as receiving 10 units or more red blood cells     (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which     clinicians make decisions about transfusion protocols for massively bleeding patients.      PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National     Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and     the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at     Level I Adult Trauma Centers in North America.   "
132913|NCT01545219|"     Healthy volunteers will be recruited to a study where they will be given four different     treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a     synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be     collected and analysed for changes in faecal microbial populations and selected immune     responses.   "
132914|NCT01545206|"     The investigators tried to determined whether the less D2B time led to costs savings     benefited insurance payer and better outcomes to patients.   "
132915|NCT01545193|"     Residual neuromuscular blockade is frequently observed in the early postoperative period when     patients have received a general anesthetic with muscle relaxants. At the present time it is     uncertain whether certain patient populations are at greater risk for this common anesthetic     complication. However, it is possible that elderly surgical patients may exhibit a higher     incidence of residual neuromuscular blockade. The aim of this clinical trial is to determine     the incidence of residual neuromuscular blockade in a cohort of younger (ages 18-50) and     older (ages 70-90) patients undergoing surgery and general anesthesia.   "
132924|NCT01544101|"     The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a     low-fat, vegan diet improves pain and other subjective symptoms more effectively than a     control supplement or a placebo. The principal measure is pain as measured by Visual Analog     Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,     respectively. The study duration is 36 weeks.   "
132926|NCT01544075|"     With the present study the investigators wish to examine if reconceptualisation of pain, by     educating chronic whiplash-associated disorders (CWAD) patients on the neurophysiology of     pain, in combination with psychologic innoculation is able to influence maladaptive (pain)     cognitions, pain (inhibition) and movement performance, and reduce symptoms.   "
132927|NCT01544062|"     Patients undergoing cardiac surgery experience significant postoperative pain, which may     impact postoperative outcomes. The aim of this single center, double-blind, randomized,     placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly     decrease 24 hour postoperative opioid consumption.   "
132928|NCT01544049|"     The purpose of this study is to better understand why women choose to have their fallopian     tubes removed as a method for ovarian cancer prevention. This will be done through a paper     questionnaire and phone interviews. The investigators hope to gain information that will     allow us to better counsel women about ovarian cancer prevention.   "
132942|NCT01545115|"     Longitudinal survey in Northern Senegal to investigate the environmental factors modulating     the immune response to childhood vaccines and to malaria.      A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor     District) was followed-up for 18 months. During that period, 5 visits have been made to the     villages to assess the immunological and nutritional status of the children.   "
132977|NCT01544660|"     Our overarching aim is to set up a procedural, analytic and developmental framework to     establish CT of the central and peripheral skeleton as a clinically useful biomarker for     skeletal strength in the clinical research and ultimately in the clinical setting. To     accomplish this, the investigators will develop and validate phantoms and scanning procedures     to standardize strength and structure measurements between different vQCT scanners and     develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with     an emphasis on optimization for multi-center studies.   "
132929|NCT01544036|"     Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated     with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM)     induce kidney injury through vasoconstriction and ischemia as well as direct tubular     toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension,     and those exposed to higher volumes of ICM are at higher risks for CN. Within the last     several years, multiple strategies have been used in clinical studies to reduce the risk of     CN in high risk individuals with inconsistent results. In general, it is agreed that volume     expansion is effective in reducing the risk. However, no study has looked at changes in renal     blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its     relationship with occurrence of CN.      In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an     estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25     individuals with normal renal function (total of up to 150 individuals) who are scheduled for     coronary angiography will be studied. Each individual will have serial measurements of RBF;     at baseline, after volume expansion with normal saline, and after exposure to ICM, using the     novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the     utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of > 0.3 mg/dL     or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other     known risk factors in the group of subjects with reduced GFR. The investigators will also     examine the correlation between RBF changes and other urinary and serum biomarkers of kidney     injury in this group. Up to 25 individuals with a normal kidney function will be studied in a     separate part of the study in which the accuracy of CEU based measurements of RBF will be     compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow     probe placed directly inside the main renal artery during coronary angiogram procedure. Total     to enroll = 150.   "
132930|NCT01544023|"     A new approach for single stage implant based breast reconstruction (BR) is the use of a     titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).     These TCPM have a good biocompatibility and can be used in a similar way as ADM. This study     addresses indications, limitations and complications of TCPM in implant based breast     reconstruction.   "
132931|NCT01544010|"     This study explored optimal tailoring strategies for population tobacco cessation in 4     treatment groups and a control group over 24 months. Transtheoretical model (TTM) tailored     feedback on all 14 variables has been found to be a robust population cessation strategy     across studies. This proposal sought to find a subset of these variables that is optimal for     tailoring, both minimizing response burden while maximizing effectiveness. Addiction     variables have been demonstrated to predict smoking outcomes across studies as well, so we     will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring     group. Optimally tailored feedback that both helps unmotivated smokers reduce their addiction     and helps motivated smokers quit could lead to a breakthrough in population cessation.   "
132932|NCT01543997|"     The purpose of this study is to investigate clinical benefits of a novel sleep-focused     mind-body program on Gulf War Illness (GWI) symptoms.   "
132933|NCT01543984|"     The purpose of this study is to test the effect of Tailored Physical Activity on the number     of sick-days.      The hypothesis is that Tailored Physical Activity is superior in efficacy on sick-days.   "
132934|NCT01543971|"     This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily     injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together.      The aim of the study is to determine the safety of the TXA127 alone and in combination with     Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen     enhances peripheral blood stem cell (CD34+)mobilization.   "
132935|NCT01543958|"     HIV-infected people can have an increase in inflammation in their body organs, even after     taking anti-HIV medicines.      Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind     endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer     carbonate decreases the inflammation endotoxin causes in dialysis patients.      A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer     carbonate administration on markers of microbial translocation and T-cell activation in the     blood in chronically HIV-infected subjects not receiving ART.   "
132936|NCT01543945|"     The purpose of this study is to compare the incidence of Postoperative nausea and vomiting     between the intervention group who received multimodal antiemetic management and the control     group who did not get this protocol.   "
132937|NCT01543932|"     Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in     patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention     (PCI) with drug eluting stent(s) implantation. Interindividual variability in platelet     response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet     reactivity [PR], variability of the drug metabolism, and various drug interactions) being     implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a     prospective, single-center, investigator-initiated, randomized, study to compare platelet     inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day     Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose     of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or > 45 Unit) and     with loss-of-function allele CYP2C19*2 will be enrolled in the study and will be randomized     (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or     Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.   "
132938|NCT01543919|"     PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is     associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to     patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety     and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)   "
132939|NCT01543906|"     The purpose of this study is:        -  To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in          RP subjects with an autosomal dominant mutation in RPE65.        -  To evaluate duration of visual function improvement (if observed) in RP subjects with an          autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001.        -  To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP          subjects with an autosomal dominant mutation in RPE65.   "
132940|NCT01543893|"     Resistance training is widely used in training and rehabilitation. During recent years     elastic resistance training has become increasingly popular for preventing or relieving     neck/shoulder/arm pain among sedentary employees. While most research studies documenting     positive effects of such interventions have used training instructors, most training in     practice does not use an instructor but rather depends on information from other sources such     as the internet. Here the investigators examine - in a outcome assessor blinded randomized     controlled trial - the effect of 2 weeks elastic resistance training for the     neck/shoulder/arm with personal versus video instruction on technical execution.   "
132943|NCT01545102|"     Cardiac rehabilitation is the ideal comprehensive intervention for patients with chronic     heart failure (CHF), since it addresses the complex interplay of medical, psychological and     behavioural factors facing these individuals. Structured exercise training within a cardiac     rehabilitation programme is firmly recommended for these patients. However, it is     questionable whether patients are achieving an adequate dose of exercise to provide optimal     benefits. The essential components for setting optimal training include the appropriate mode,     duration, frequency and intensity of exercise. UK surveys of cardiac rehabilitation describe     the frequency and duration of training, but here is scant information on exercise intensity.     However, it is apparent that randomised controlled trials of exercise training use doses more     than 4 times greater than in UK current practice. The Eastbourne Exercise Cardiology Research     Group has demonstrated that although patients benefit from improved quality of life and     submaximal fitness after a hospital outpatient cardiac rehabilitation programme, they do not     achieve the increases in important prognostic indicators reported by the majority of exercise     training trials.      The critical factor in terms of eliciting a sufficient training effect while minimising risk     is the intensity of the exercise performed. It is now widely accepted that the traditional     methods of using fixed percentages of maximal heart rate or oxygen uptake to set exercise     intensity include serious errors. The European Society of Cardiology recommends that     cardiopulmonary exercise testing should be used to provide an objective evaluation of the     metabolic demand of exercise. This allows physiologically meaningful reference points to be     established for aerobic exercise prescription and is the solution to defining safe and     effective training intensities. The next step is to determine whether this information can be     transferred to a practical cardiac rehabilitation environment to set and monitor exercise     intensity   "
132944|NCT01545089|"     The main objective of this research project is to measure the impact on patient satisfaction     of the use of a fabric mattress cover fabric on a bedsheet protecting a plastic mattress.   "
132945|NCT01545076|"     This is a prospective, multicenter, randomized, double-blind, placebo-controlled,     parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20     compared with placebo for maintenance treatment of patients with CIDP.      Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks     before screening will be assessed during 4 separate study periods. Patients first undergo a     Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for     ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be     administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients     with improved and maintained adjusted inflammatory neuropathy cause and treatment scale     (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the     study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly     infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.      The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the     Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical     Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and     electrophysiological evaluations.   "
132946|NCT01545063|"     This research aims to give an overview of a number of aspects related to the quality of care     for adult patients on home parenteral nutrition.      Concretely this study follows up different aspects on different moments in the care of the     patient pathways:        -  process indicators concerning indication, parenteral nutrition, training, team access          roads and the succession of complications        -  Outcome indicators        -  the health-related quality of life        -  discrepancies in medication use        -  the role of the different health care providers   "
132947|NCT01545050|"     The purpose of this study is to characterize the safety, efficacy and dose response of     BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an     insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor     (anti-TNF) therapy.   "
132948|NCT01545037|"     The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms     of IBS.   "
132958|NCT01544907|"     A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty     versus conventional percutaneous transluminal angioplasty balloon for the treatment of     hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal     loss and restenosis rates, while prolonging primary and secondary patencies.   "
132949|NCT01545024|"     Rocca et al. reported first that the secretion of incretins, particular GLP-1 in rat is     regulated by the enteric nervous system, the afferent and efferent vagus nerves [1]. Further,     Kazakos et al. [2] reported that autonomic nerve disturbance (AND) in patients with T2DM     impaired the incretin effect owing to decreased GLP-1 secretion. However, Toft-Nielsen et al.     [3] reported that the decreased GLP-1 responses in the patients with type 2 diabetes mellitus     (T2DM) are unlikely to be related to the AND and, thus, did not support the results of Rocca     et al. and Kazakos et al. Recently, Yabe at al. [4] also observed the same observations in     Japanese patients with T2DM. Meanwhile, Jin et al. reported that administration of DPP-IV     inhibitor recovered the disturbance of diabetic nerve dysfunction in rat [5]. However, it is     unknown whether the administration of DPP-IV inhibitor effects on the AND in human, although     many studies are performed to investigate the effect of the DPP-IV inhibitors on glycemic     control.      Accordingly, it is significant to reinvestigate an effect of DPP-IV inhibitor on glycemic     control and autonomic neuropathy in diabetic patients.   "
132950|NCT01545011|"     The purpose of this study is to determinate whether inspiratory muscle training (IMT)     associated with a conventional respiratory rehabilitation program is more effective than a     conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive     pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).   "
132951|NCT01544998|"     This study is being done to determine the effects of subcutaneous (under the skin) injection     of human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the     heart, in combination with Tadalafil on:        -  The pumping function of the heart        -  Kidney function        -  Hormonal function (levels of different hormones in your blood) in persons with lower          pumping function of their heart.   "
132964|NCT01544829|"     The main aim of this study is to determine whether there is a difference in the physiological     effects of theobromine when provided via a single serving compared to multiple servings     adding up to the same amount of theobromine provided on a day.      This study also aims to study the pharmacokinetics of theobromine after administration once     per day versus administration 4 times per day.      Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is     given in 4 smaller doses.   "
132965|NCT01544816|"     To determine the effect of snack products varying in composition, on energy in healthy adult     subjects.   "
132989|NCT01544504|"     This study, a nonrandomized open-label safety and exploratory study, will evaluate the safety     of topical norepinephrine in post-surgical breast cancer patients who are undergoing     radiation therapy.      The study will also provide information about whether topical norepinephrine can prevent or     decrease the severity of the radiation dermatitis experienced by these patients.   "
132952|NCT01544985|"     INTRODUCTION AND JUSTIFICATION      The use of sucrose has been well studied for certain procedures in neonatal intensive care     unit patients and in the newborn nursery settings, particularly for venous blood draws,     capillary blood tests and circumcision. In these studies, infants receiving oral sucrose     solutions before procedures cried less and had overall decreased behavioural pain responses     when compared with those receiving placebo.      In Emergency Departments (ED), children undergo many painful procedures, such as bladder     catheterization, capillary blood tests, venipuncture and lumbar puncture. Only two studies     have examined the effectiveness of sweet solutions as an analgesic in the ED. A randomized     controlled trial in an emergency setting of sucrose and/or pacifier for infants receiving     venipuncture conducted by Curtis and al among infants of 0 to 6 months demonstrated a trend     in reducing pain among the sub-group of infants of 0 to 3 months. However, this study showed     no difference in pain scales after 3 months of age. Also, in a study examining the effect of     sucrose during bladder catheterization, the subgroup of infants 1 to 30 days old who received     a sweet solution showed smaller changes in pain scores, were less likely to cry during     catheterization and returned to baseline more quickly, in comparison with the placebo group.     However, among children of 31 to 90 days, there was no statistically significant difference     in pain scores. In this study, they used a sucrose solution of only 24% and as they said in     the discussion, it is possible that older infants, who on average received a smaller dose (in     milligrams per kilogram), were in fact underdosed.      Finally, the painful procedure chosen for this study is bladder catheterization. Bladder     catheterizations are frequently performed in the ED in this age group.      HYPOTHESIS The investigators believe that providing an oral sucrose solution during bladder     catheterization will decrease pain levels in infants 1 to 3 months of age.      OBJECTIVES The investigators primary objective is to compare the efficacy an oral 88% sucrose     solution to a placebo solution in reducing pain as assessed by the FLACC scale in children of     1 to 3 months during bladder catheterization in the ED. The investigators secondary objective     is to asses changes in pain levels as per the NIPS score. The investigators will also measure     variations in heart rate and crying time. All side effects will also be reported.   "
132953|NCT01544972|"     The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety     in relation to serum levels in closure of patent ductus arteriosus in preterm infants.   "
132954|NCT01544959|"     The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol     during general anesthesia for patients undergoing mastectomy will result in less pain and     less narcotic consumption in the recovery room. The investigators will also verify the impact     of that substitution on nausea and vomiting, on the time spent in the recovery room and on     chronic postsurgical pain (3 and 6 months).      Finally, the investigators will see the impact on breast cancer recurrence 5 years after the     surgery.   "
132955|NCT01544946|"     Background: Early recognition and treatment of pain among children is important for their     cognitive development and their future response to pain throughout their life. Oral sweet     solutions have been accepted as effective pain reducing agents for procedures in the neonatal     population. To date, there have been a limited number of published clinical trials in an     emergency setting studying this type of intervention among infants undergoing venous puncture     and bladder catheterization. These studies have reported conflicting results. No previous     studies have evaluated the utilization of sucrose to manage pain during nasopharyngeal     aspiration.      Objective: To compare the efficacy of an oral sucrose solution versus placebo in reducing     pain in children one to three months of age during nasopharyngeal aspiration in the Emergency     Department.   "
132956|NCT01544933|"     The purpose of this study is to analyse the anatomic influence of the ribs related to the     incidence and severity of burst spine fractures.   "
132957|NCT01544920|"     The primary purpose of this study is to compare the efficacy of two boceprevir     (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic     hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.      The regimens differ in the treatment for participants who achieve undetectable HCV     ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV)     4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm     2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants     with undetectable HCV RNA at Follow-Up (FU) Week 24.   "
132959|NCT01544894|"     The purpose of this study was to compare compliance and efficacy of raloxifene and strontium     ranelate in a group of women with postmenopausal osteoporosis.   "
132961|NCT01544868|"     The purpose of this study is to measure resting energy expenditure, total energy expenditure,     and physical activity in recovering burn children to better understand their relation to     impaired growth and nutritional status; and to measure whole body and muscle protein turnover     during recovery from burn injury to understand their impact on body composition and energy     metabolism. It also aims to look at changes in lean body mass, fat mass, bone mineral density     and bone mineral content during rehabilitation and during early convalescence.   "
132962|NCT01544855|"     Genetics and nutrition both clearly affect the risk of Alzheimer's disease (AD) in the     elderly. Apolipoprotein E (APOE4) is the most important known genetic risk for AD and is     prevalent in 20-25% of Canadians, but at present, knowing an individual's ApoE genotype does     not help the diagnosis, treatment or prevention of AD. Furthermore, fish intake containing     docosahexaenoic acid (DHA, 22:6 omega-3) and eicosapentaenoic acid (EPA, 20:5 omega-3) may be     incorporated as a prevention strategy for lowering the risk of AD. However, fish intake seems     not to protect APOE4 carriers from developing AD. One explanation as to why APOE4 carriers     may not benefit from fish intake is potentially linked with imbalances in omega-3 fatty acid     metabolism. The investigators recently reported that after 3g/d of EPA+DHA for 6 weeks,     increases in the two fatty acids was less for carriers resulting in a significant     gene-by-diet interaction. ApoE is a component of lipoproteins and ApoE genotypes modulate the     fasting lipoprotein response to fish-oil supplementation. Therefore, the investigators     hypothesis is that APOE4 genotype is associated with imbalances in lipoprotein concentrations     which has the consequence to be associated with imbalances in EPA and DHA transport. The     investigators will recruit and test 100 healthy young adults since at older ages carriers of     ApoE4 usually take medication altering their lipoprotein profile. They will receive an EPA +     DHA supplement for one month. This period was chosen because the 3 class of lipoproteins     (VLDL, LDL and HDL) have different concentrations in TG, phospholipids and cholesteryl esters     and to fully investigate lipoprotein fatty acid changes, one month of supplementation is     needed to change EPA and DHA in all lipid classes. The investigators will monitor the     distribution of EPA and DHA in the lipoproteins over a one month supplementation with fish     oil and the investigators will separate the investigators groups by APOE4 carriers and     non-carriers.   "
132963|NCT01544842|"     The purpose of this study is to compare the effectiveness of topical tacrolimus,     triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).   "
132975|NCT01544686|"     In neutropenic cancer patients, catheter-related bloodstream infections may cause severe     infections and even death. To assess the prophylactic effect of a chlorhexidine coated     catheter securement dressing on the incidence of catheter-related bloodstream infections,     this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be     randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.   "
132966|NCT01544803|"     Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed     randomized controlled design, measuring outcomes in terms of changes in problematic alcohol     use up to one year after study recruitment. The eScreen brief Internet intervention for     problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized     feedback and treatment recommendations as well as an electronic diary. Progress over time is     shown in diagrams detailing consumption levels. A more extensive Internet intervention for     problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a     solution-oriented focus, electronic diary and moderated chat-forum.      Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are     randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen     referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related     symptoms are assessed after 3, 6 and 12 months.      The first hypothesis is that all three groups will reduce their alcohol consumption and     alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis     is that there will be no differences between participants in the eScreen and the     Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at     follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen     group will show a greater reduction in alcohol consumption and alcohol-related problems     compared to the control group (no intervention) at follow-ups. For a greater understanding of     the study results possible other interventions received by the study participants for their     problematic alcohol use during these 12 months of study participation will be investigated.   "
132967|NCT01544790|"     This is the first randomized controlled trial designed to compare robot-assisted minimally     invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical     treatment for resectable esophageal cancer.      If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic     esophagectomy will result in a lower percentage of postoperative complications, lower blood     loss, shorter hospital stay, but with at least similar oncologic outcomes and better     postoperative quality of life compared with the open transthoracic esophagectomy (current     standard).   "
132968|NCT01544777|"     To evaluate visual acuity and quality of vision in participants undergoing cataract surgery     with a Hoya model 751 intra-ocular lens and to compare the visual results to the common     monofocal lens in use.   "
132969|NCT01544764|"     The North Carolina Immunization Branch will evaluate the use of the CDC program to improve     adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or     AFIX). This evaluation is the first of its kind in the nation and may have a profound impact     on prevention.      AFIX has four major components: 1) Assessment of a provider's current immunization practices     and vaccination levels, 2) Feedback of the assessment results and strategies to improve     coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and     resources necessary to facilitate improvement.      This program will evaluate the effectiveness of AFIX visits on affecting provider practices     to increase adolescent (age 11-18) immunization. Visits include discussion of that practice's     immunization rates and strategies for improving rates. The investigators will compare the     changes, from baseline to 5 months, in immunization for practices receiving virtual visits     (webinars), in-person visits, and no visits (control group). Thirty practices will be     randomly assigned to each intervention type. The main outcomes of this study are     practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as     pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data     will be collected on practices with at least 200 adolescent patients (note: there is no     patient-level data collected in this study).   "
132970|NCT01544751|"     The first line approach to NAFLD is currently based on diet and lifestyle modification. Aim     of our Unit is to compare the efficacy of two different doses of metformin (1 g/day and 2     g/day) with atorvastatin (20 mg/day) on amelioration of inflammatory and cardiometabolic     parameters, ultrasound signs and clinical scores associated with liver fibrosis in     early-stage NAFLD non-diabetic patients.   "
132971|NCT01544738|"     Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease (PD).     Several studies have shown that patients with PD exhibit slowness because they are unable to     modulate, in an optimal way, the velocity of voluntary motor acts not induced by external     stimulation. Indeed, these patients have difficulties to integrate multi-sensorial     information, mainly proprioception.      The investigators investigated changes in shoulder velocity during pointing movements by     patients with PD after stimulation of soft tissues (aponeurosis) of upper limb muscles. The     stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the     aponeurotic tissues enrobing the heads of the upper limb muscles. This technique has     previously been shown to decrease passive tension and the tendon reflex response of the     manipulated muscle group. The investigators hypothesis is that aponeurotic manipulation of     shoulder muscles therefore creates a modification in the proprioceptive information, which in     return temporarily decreases the bradykinesia of shoulder movements.   "
132972|NCT01544725|"     Using Ketamine for procedural sedation in adults is often uncomfortable for emergency     physicians because of the significant proportion of patients experimenting recovery     agitation. The investigators believe that combining propofol to ketamine, the proportion of     recovery agitation will be significantly lowered.      The objectives of this double-blinded, randomized controlled trial are to compare the     proportion of recovery agitation in adults receiving procedural sedation with     ketamine-propofol versus ketamine alone, and to compare the proportion of other classical     procedural sedation side-effects and parameters such as respiratory depression, hypotension,     sedation duration, time of recovery, procedural failures, and levels of satisfaction.   "
132973|NCT01544712|"     In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow     grafting was reported with a reduction of the functional evolution and the necessity of a     total prosthesis placement in a non-controlled retrospective trial. Based on this experience,     the investigators would like to start a randomized controlled double blind study on the     effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of     stage 3 ON of the femoral head.   "
132974|NCT01544699|"     tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to     improve a variety of functions with superior or inferior limb.   "
132978|NCT01544647|"     Non-pharmacological treatments are recommended for the management of knee osteoarthritis     (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving     symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known     about the advantage of one modality of thermal therapy over another.      The main objective of the study is to compare the number of patients achieving a composite     response criteria associating the minimal clinically important improvement at 6 months,     defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised     Western Ontario and McMaster Universities osteoarthritis index function score and no knee     surgery in 2 spa therapy protocols (a usual protocol and an active protocol) in knee     osteoarthritis.      The secondary objectives are:        1. To compare the efficacy of the 2 protocols at 3 months.        2. To determine the evolution of quality of life and medical care consumption        3. To describe postural abnormalities        4. To determine predictive factors to a favourable response at 3 and 6 months   "
132979|NCT01544634|"     Current asthma medicines include inhalers. A common type of inhaler is called a     'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the     airway causing it to widen. Although these drugs are useful short term, long term use can     make asthma worse in some people.      'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in     patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including     severe asthma attacks.      The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer'     medication. These work by dampening down the inflammation in the lungs that occurs in asthma.      New research has suggested that longer term use of beta-blockers can also reduce airway     inflammation which may improve asthma control. This research was done in asthmatic patients     who didn't need inhaled steroids to control their asthma. At the moment the investigators are     studying to see if there is a benefit of beta-blocker use for asthma over and above     asthmatics own usual doses of inhaled steroids.      In this study, the investigators will be trying to find out if adding a beta blocker to a     smaller dose of steroid inhaler has the same effect on asthma control as just using a higher     dose of steroid inhaler by itself.   "
132980|NCT01544621|"     Real life smoking cessation rates after 24 weeks non-intervention design. Approximately 40     General Practice (GP) centers with 800 smokers will participate.   "
132981|NCT01544608|"     The primary objective of this Non- Interventional Study (NIS) is to describe the use of     atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to     acute psychotic episode by evaluation of drug, dose and mode of administration of the     medication.   "
132982|NCT01544595|"     This is an extension study of secukinumab prefilled syringes in subjects with moderate to     severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with     secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies     (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III     studies) will be eligible to join this extension study. This extension study is planned to     collect an additional 2 years of long-term efficacy, safety, and tolerability data of     secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in     subjects showing at least partial response to secukinumab and completing treatment period on     secukinumab in previous phase III studies. In this extension study, the prefilled syringe     (PFS) liquid formulation of secukinumab will be used.   "
132983|NCT01544582|"     This is an observational prospective follow-up study to assess the utilization of boceprevir     and the management of pre-specified health outcomes of interest (HOIs) under conditions of     routine clinical care in participants with chronic hepatitis C (CHC) genotype 1.      As an observational prospective study, this study is not intended to change the     participant/physician relationship, nor influence the physician's drug prescription or     therapeutic management of the participant. No individual administration of any therapeutic or     prophylactic agent is assigned in this protocol, and there are no procedures required as part     of this protocol. Physician choice of the drug used to treat the participant is based on     clinical judgment alone.   "
132985|NCT01544556|"     Abdominoplasty is one of the most commonly performed procedures in plastic surgery. The     appearance of the scar is a major factor contributing to the aesthetic outcome of the     procedure and depends largely on the technique of wound closure. The investigators routinely     used resorbable subcutaneous sutures and resorbable intracutaneous sutures for this closure.     To overcome the potential detrimental effects of sutures in skin closure, surgical adhesives     were introduced as a new technology. The new PrineoTM wound closure system was created to     combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a     self-adhering mesh to make closure of long skin incisions even more safe and reliable.     PrineoTM has the potential to offer a patient several benefits over traditional wound closure     with sutures.A patient treated with Prineo™ can shower immediately following a procedure     because the product forms a watertight barrier over the incision. PrineoTM can be easily     removed, often with less pain than is sometimes associated with suture removal, after the     natural wound healing process is complete (approximately 12 to 25 days). Other benefits are     that it forms a microbial barrier and provides even distribution of tension across the length     of the incision to ensure wound edge approximation throughout the wound healing process.     Furthermore, it reduces subcuticular closure time as compared to subcuticular suturing.      However, these potential advantages have not been proven until now, as the methods used to     assess the aesthetic outcome were not reproducible in most assessments, and none of these     studies assessed patient satisfaction.1-3 Moreover, none was performed in a plastic surgical     patient population. For these reasons, the investigators prospectively studied the results of     wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing     to assess the possible difference in outcome between these two methods.   "
132986|NCT01544543|"     VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability     and interobserver reliability) of healthcare quality standards in chronic obstructive     pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery     Society), and at establishing the foundation for a future validation (construct and criterion     validation) of the aforementioned standards.   "
132987|NCT01544530|"     The purpose of this study is to assess the feasibility and safety of mild-to-moderate     hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60     brain-dead organ donors.   "
132988|NCT01544517|"     A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential     therapy for eradication of H. pylori infection.   "
132990|NCT01544491|"     The purpose of this study is to determine if everolimus combined with reduced exposure CNI     (TAC) is efficacious and safe and will support corticosteroid elimination compared to a     standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation.     An additional purpose of the study is to assess the effect of the combination of EVR and     reduced exposure CNI (TAC) on renal function.      This study is part of the requirements of the Paediatric Investigational Plan approved by     Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and     is intended to support the indication of everolimus in the prevention of acute rejection in     paediatric recipients of a renal transplant.   "
132991|NCT01544478|"     This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6,     11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial     neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese     women.   "
132992|NCT01544465|"     The purpose of this study is to examine the ability of a structured physical activity program     to improve sleep quality and daytime sleepiness in patients with Parkinson's disease.   "
132993|NCT01544452|"     Patients with rectal cancer undergo MRI of the rectum, CT of the thorax and abdomen (or     thorax x-ray and ultrasonic liver evaluation) and colonoscopy as a total diagnostic     evaluation before surgery. MR colonography have been shown to have high sensitivity and     specificity for larger polyps and cancer and MRI of the liver have been shown to have similar     or higher sensitivity than CT of the liver for metastasis. Since patients already undergo MR     of the rectum, the investigators have proposed a total diagnostic evaluation with MRI of the     liver, abdomen, colonography and rectum in one session (minus thorax evaluation) instead of     two or three different methods of evaluation. The investigators hypothesis is that the total     MR evaluation is equal or superior to the existing preoperative evaluation regarding the     diagnosis of synchronous cancers and liver metastasis and regarding cost-benefit for the     total diagnostic evaluation.   "
132994|NCT01544439|"     The aim of this study was to evaluate the effectiveness of the splint occlusal associated     with counseling in reducing pain in patients with temporomandibular disorders, under the     assumption that the occlusal appliance offers the highest rates of improvement than their     placebo.   "
132995|NCT01544426|"     Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI)     cycles , in cases of repeated implantation failure. It is found that it will improve the     implantation rate.   "
132996|NCT01544413|"     Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric     cancer is less invasive method which can increase quality of life. Multicenter phase III     trial is requred to validate this method. In this study all items which are necessary for     laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated     the performance completement.   "
132997|NCT01544400|"     Athletes in particular elite athletes have obsessional food and body concerns, in bond with a     worship of the performance more and more invading, which lead to clinical and subclinical     eating disorders. These eating disorders differ according to the disciplines and are     difficult to diagnose in athletes because there are insufficiently described.      Our aim at estimating the frequency of eating disorders in athletes and describing eating     disorders by means of somatic, dietetic and psychological evaluations.   "
132998|NCT01544387|"     The objective of this study is to determine, through a randomized clinical trial, whether bed     rest is helpful for the management of pregnancies complicated by preterm premature rupture of     membranes (PPROM).   "
133029|NCT01543711|"     Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently     occurring late effects of breast cancer treatment. The investigators have previously     published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006.     Very few studies have examined how these late effects change in time. The aim of this study     is to examine in a well defined patient population any change in the prevalence of persistent     pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor     profile.   "
133058|NCT01543334|"     The primary objective of the DALI study is to compare antibiotic concentrations in patient     blood samples with bacteriological objectives associated with maximum bactericidal activity.     The antibiotics studied are certain lactams and glycopeptides.   "
132999|NCT01544374|"     Breast cancer is the second most common cause of cancer death in women. Black women are less     likely than white women to develop breast cancer but, they are more likely to die of the     disease. Some of this survival discrepancy is likely due to underuse of adjuvant therapies     proven to increase survival. Breast cancer treatment often requires coordination among     surgeons, pathologists, primary care physicians, medical and radiation oncologists. In NYC,     black and Hispanic women who accessed care and underwent surgical treatment of their breast     cancer were twice as likely as whites to experience underuse of adjuvant treatment.     Disturbingly, 1/3 of these underuse cases were episodes in which the surgeon recommended     treatment, the patient did not refuse and yet, care did not ensue. Underuse in such     circumstances is attributable to system failures than to specific provider or patient     factors.      In this proposed randomized controlled trial, the investigators aim to test the effectiveness     of a Tracking and Feedback (T&F) registry innovation to increase rates of completed oncology     consultation and reduce both underuse of needed adjuvant therapy and racial disparities in     receipt of these treatments. The investigators also aim to assess the feasibility of     implementing a T&F Registry in these high-risk hospitals by evaluating implementation     effectiveness for that innovation. The investigators have recruited 10 hospitals that serve     large proportions of minority women with breast cancer. The investigators will randomize     hospitals and aim to recruit 354 women with a new breast cancer, 177 per intervention arm.     The investigators choose these high risk hospitals because they serve predominantly     minority populations, and such hospitals have higher rates of the system failure cause of     underuse, and particularly, the type of underuse targeted by our Tracking and Feedback     Registry.   "
133000|NCT01544361|"     This is a Phase 1 study to evaluate the safety and tolerability of single ascending     intravenous doses of MEDI7814 in healthy adult subjects.   "
133001|NCT01544348|"     Phase 1 study to evaluate the safety of MEDI4212.   "
133002|NCT01544335|"     The purpose of this study is to determine whether measuring the fluid in your arms using     Bioimpedance Spectroscopy is as effective at detecting and monitoring lymphedema as     measurements with the Perometer. The investigators will also evaluate any symptoms you may     experience in your arms during and after treatment for breast cancer with a questionnaire.   "
133003|NCT01544322|"     The purpose of this study is to determine the tolerability of ME-344, find the maximum     tolerated dose, and the safety profile in patients with refractory solid tumors.   "
133004|NCT01544309|"     The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid     lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes     mellitus.   "
133005|NCT01544296|"     This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and     safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.   "
133006|NCT01544283|"     Objective:      This purpose of this pilot study is to explore the potential usefulness of Synera for the     treatment of pain associated with shoulder impingement syndrome.   "
133007|NCT01544270|"     The study aims to investigate the role of dietary factors in chronically stressed subjects.     Previous studies have shown that milk proteins, B vitamins and probiotics may influence on     subjective well-being in stressed subjects.   "
134859|NCT01519648|"     Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute     leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of     chemotherapy), and hematopoietic stem cells transplantation.   "
133008|NCT01544257|"     The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented     and results from previous studies suggest the association between OMT and length of stay     (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of     the present study is to show the effect of OMT on LOS in a sample of premature infants.   "
133009|NCT01544244|"     The primary objective of this study is to demonstrate the superiority of the CGE physical     therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the     following after 1 month of physical therapy: the FI2S score including validated measures of     pain, glenohumeral joint range of motion in the three planes, the ability to perform certain     everyday activities and the strength of forward elevation measured with a dynamometer.   "
133010|NCT01544231|"     This research project consists of a prospective diagnostic study conducted on patients with     clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University     Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main     objective of this study is to determine whether the plasma level of Neutrophil Gelatinase     Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF)     occurring within 48 hours after admission for rhabdomyolysis.   "
133011|NCT01544218|"     Alcohol use is a serious health threat to the 26% youth in the US with chronic medical     conditions. While alcohol use can significantly impact an underlying illness and its     safe/effective management, medical specialists rarely screen their adolescent patients for     alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18     year old youth with chronic medical conditions. Comprehensive assessment information will be     collected and analyzed to describe relationships between youth alcohol use, other substance     use, and chronic disease outcomes and findings integrated into the validated screen as     actionable clinician guidance and health advice.   "
133012|NCT01544205|"     The purpose of the study is to investigate whether neurofeedback delivered via functional     magnetic resonance imaging signals can be used to train depressed patients to self-regulate     emotion networks and whether this improves clinical symptoms.   "
133013|NCT01544192|"     Background: The significance of retinal ganglion cell protection in the glaucoma led the view     that, glaucomatous optical neuropathy can also be considered as a pathology of central     nervous system. It is known that α−tocopherol and Gingko Biloba have specific neuroprotective     and vasoregulatory activities, in addition to antioxidant effects. In this study, the     investigators compared early neuroprotective effects of α−tocopherol and GB with each other     as well as control and a strong antioxidant formulation in patients with glaucoma.      Methods: In this non-randomized control trial, 120 eyes of 60 patients with glaucoma were     enrolled into the study and divided into 4 groups, each consisting of 30 eyes. Unlike the     controls, patients in the 3 antioxidant groups received α−tocopherol, Gingko Biloba and a     strong antioxidant formula for 3 months. Central vision field and MD, PSD and OCT as well as     thickness of retinal nerve fiber layer, ganglion cell counts and c/d ratios were recorded.     The data were compared statistically.   "
133014|NCT01544179|"     The purpose of this study is to assess the efficacy and safety of gefitinib in patients who     have progressed on first line gefitinib, comparing continuing gefitinib in addition to     cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed     combination chemotherapy alone.   "
133071|NCT01543165|"     This study is to see whether the combination regimen of ketorolac and nefopam is superior to     that of ketorolac and morphine in controlling ureter stone-related acute flank pain.   "
133015|NCT01544166|"     The main purpose of this study is to collect data on the way gadobutrol is taken into, moves     around, and is eliminated from, the body of children aged 0 to less than 2 years. The study     will also evaluate safety and tolerability, and efficacy of gadobutrol.      A maximum total amount of approximately 5 ml of blood will be needed for these analyses which     will be drawn within 2-3 days.      Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI),     potentially allowing better visibility of tissues in the body. Children aged under 2 years     scheduled for a routine contrast-enhanced MRI examination of any body region may take part in     this study, in which case they will receive gadobutrol as contrast agent intravenously at the     standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal     insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate <80% of age     adjusted normal value calculated based on the Schwartz formula) will be included in the     trial.      The duration of this study as a whole is around 1 year and the total number of children to be     enrolled is 50. A child will be expected to take part in the study for around 7 days.   "
133016|NCT01543880|"     This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in     adults treated with somatropin (Norditropin®).   "
133017|NCT01543867|"     This study is conducted in Europe. The aim of this study is to evaluate safety during the     long-term use of somatropin (Norditropin®) in children as well as efficacy on change in     height. A subgroup of children small for their gestational age is included.   "
133018|NCT01543854|"     This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart     failure. In addition safety and effects on renal function and biomarkers will be assessed.   "
133019|NCT01543841|"     Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in     healthy individuals and in people with cancer. These cells may play a role in the growth of     blood vessels (veins/arteries), and may be particularly important in the growth of blood     vessels that supply tumours. Understanding how these cells work may therefore help     researchers to develop cancer treatments that starve tumors of their blood supply.      This research study involves an analysis of the behaviour of blood cells in response to     different drugs in a test tube. The goal is to develop tests that can then be used to monitor     patients treated with drugs that target blood vessel growth.   "
133020|NCT01543828|"     This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in     moderate-severe COPD patients with breathing symptoms to assess time to patient's perception     of onset of effect.   "
133021|NCT01543815|"     The WELL-ME study is a three-arm randomized controlled clinical trial (RCT). The aim of this     RCT is to compare the effectiveness of the Well Being Web Based Therapy (WBT-Web) with the     gold standard CBT (Cognitive Behavior Therapy) and standard clinical procedure of patients'     management (CM) for psychological distress and promotion of healthy behaviors in Cardiac     Patients.   "
144631|NCT01391286|"     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with     vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy     treatment.   "
133022|NCT01543802|"     The purpose of this study is to examine if a short-term treatment with pazopanib, an oral     drug inhibiting the growth of blood vessel, can reduce the metabolism of soft-tissue sarcomas     and thus facilitate their resection when given prior to surgery. Moreover, the study assesses     the prognostic and predictive value of several new biomarkers (endothelial progenitor cells,     soluble vascular epithelial growth factor),   "
133023|NCT01543789|"     The use of mesh in the repair of umbilical hernias is a gold standard. The best location of     the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity     (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in     contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of     polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory     ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and     subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the     surgery.      This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene     for preperitoneal use), will be used in this multicentric trial, to evaluate the best     procedure in terms of efficacy, safety and postoperative complications.   "
133024|NCT01543776|"     This randomized phase II trial studies the best way to give abiraterone acetate in treating     patients with castration-resistant prostate cancer. Abiraterone acetate is effective in     treating castrate resistant prostate cancer and is taken in the fasting state. However, the     body's absorption of abiraterone is increased with food intake. This study will test the     whether a lower dose of abiraterone taken with food has a similar effect on prostate specific     antigen (PSA) compared to full dose taken fasting.   "
133025|NCT01543763|"     This is a open-label non-randomized, dose escalation and expansion Phase Ia/b study to     determine the safety, tolerability and maximum tolerated dose (MTD) of pazopanib in     combination with PCI-24781 in patients with advanced solid tumors.   "
133026|NCT01543750|"     Episodic ataxia type 2 (EA2) is a rare familial neurological condition characterized by     debilitating episodes of vertigo and imbalance. Since the serendipitous discovery of dramatic     response of EA2 to acetazolamide, acetazolamide has been the first-line treatment for EA2.     Yet, for those patients who do not respond to or cannot tolerate acetazolamide, there is no     alternative treatment. The purpose of this randomized trial is to test whether     4-aminopyridine may reduce the ataxia episodes in EA2 as an alternative to acetazolamide.     Funding Source - FDA OOPD   "
133027|NCT01543737|"     The purpose of this study is to assess whether a single injection hyaluronic acid (HA)     product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of     effectiveness in reducing pain when walking in patients suffering from symptomatic     tibiofemoral osteoarthritis of the knee.   "
133028|NCT01543724|"     The investigators will assess Li-induced gray matter volume changes with regard to the     endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more     attributable to neurotrophic and neuroprotective characteristics of Li, which were closely     related to the inhibition of apoptotic activity of GSK3beta.   "
133056|NCT01543360|"     The main objective of this study is to compare the rate of successful establishment of a     central venous catheter in the first two attempts of ultrasound-guided puncture between two     techniques: (1) a subclavian technique versus (2) an axillary technique.   "
133030|NCT01543698|"     This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate     the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple     combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part     to assess the clinical efficacy and to further assess the safety of the combinations in     selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous     schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off     schedule. Patients will be treated until progression of disease, unacceptable toxicity     develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28     days. The dose escalation parts of the trial will be conducted in adult patients with BRAF     V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the     dual combination and at least 12 patients for the triple combination. The dose escalation     will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D     declaration, patients will be enrolled in three Phase II arms for the dual combination and     one Phase II arm for the triple combination. All patients will be followed for 30 days for     safety assessments after study drugs discontinuation. All patients enrolled in the Phase II     part of the study will be followed for survival.   "
133031|NCT01543685|"     The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and     effective for the treatment of postoperative bunionectomy pain.   "
133032|NCT01543672|"     Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer     patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation     study.   "
133044|NCT01543516|"     The aim of this case-control study is the comparison of the cell distribution in induced     sputum in young adults with asthma and in healthy controls.      The study consists of two visits. At both visits subjects are asked to perform a lung     function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured.     At the first visit a blood sample is drawn to determine the inflammatory and allergic status     of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit     another sputum sample is induced by a nozzle nebulizer. The cell distribution will be     evaluated in both sputum samples.   "
133045|NCT01543503|"     This prospective, multi-center, observational study will assess the efficacy and safety of     treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab)     as the first biologic therapy. Data will be collected for 52 weeks.   "
133046|NCT01543490|"     The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305     (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active,     symptomatic Blepharitis.   "
144632|NCT01391273|"     This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with     vehicle in Japanese adults with hypotrichosis of the eyelashes.   "
133033|NCT01543659|"     The purpose of this study is to define the safety and accuracy of 89Zr-DFO-huJ591 PET scans.     By improving our ability to find cancer cells, the investigators hope to be able to improve     treatment for patients in the future.      The study doctors want to determine whether a new kind of scan, called a 89Zr-DFO-huJ591 PET     scan, can specifically see prostate cancer that has spread to other parts of the body,     especially the bones. The study doctors will also look at how the 89Zr-DFO-huJ591 reacts with     the body and how long it stays in the body. The investigators will also ask the patient to     have a biopsy performed. The study doctors will compare the findings the investigators see on     the scans with findings on the optional tissue biopsy. Finally, the investigators will     compare the pictures from a 89Zr-DFO-huJ591 PET scan with those of a standard PET scan     (called FDG PET) and standard CT scans or magnetic resonance (MRI) scans or bone scans,     depending on which standard scans the doctor has ordered.      PET scanning uses a small amount of radiation attached to a molecule that is taken up by the     cancer. In this trial, the patient will undergo two types of PET scans. One uses FDG. FDG is     a standard tracer for PET scans. The patient will also undergo another type of PET scan that     is experimental. This experimental PET uses a radioactive protein called J591. The radiation     source is a type of metal called zirconium-89 (89Zr). The whole tracer, J591 plus the 89Zr,     is abbreviated as 89Zr-DFO-huJ591. This tracer is what is being studied. The tracer used in a     scan should find where the cancer is in the body.   "
133034|NCT01543646|"     The RIAL study aims to investigate whether non-invasive measurement of liver fat, iron     content and fibrosis are as accurate as liver biopsy specimens in determining if patients     have non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH), or other suspected     liver disease.      Currently, the gold-standard for the diagnosis and staging of liver disease is a liver     biopsy.      In this study, consecutive patients will be offered a multiparametric MR scan to assess their     liver while they await a liver biopsy.      Study time-frame: The scan will be performed in the 6-week period before their biopsy, and     results will be compared to biopsy findings. results will be presented at the end of the     study when MR data outcomes are compared to gold-standard biopsy dat. Participants will only     have to attend one study visit to participate - there will be no patient follow-up.   "
133035|NCT01543633|"     The purpose of this study is to investigate how the commonly used anesthetic drug propofol     works in the brain to produce loss of consciousness. While under general anesthesia your     brain waves will be measured using electroencephalogram (EEG). On a separate day, the     patient's brain will be imaged using magnetic resonance imaging (MRI).   "
133036|NCT01543620|"     The project is designed to test new biomarkers that are more sensitive than the current     standard in detecting injury to the proximal kidney tubule and will establish better criteria     for when kidney safety concerns may halt further testing of a drug in humans.   "
133037|NCT01543607|"     Patients with malignant bile duct stenosis have poor prognosis and most of the patients are     not good candidate for surgery at the time of diagnosis. Placement of the stent is the     palliative care for these patients. However over 50% of the stents get blocked within 6-8     months. Use of the radiofrequency ablation before the stent placement may improve stent     patency. Heat will be applied to the bile duct in order to open the blockage and prevent the     re-growth of tissue into the stent. The investigators are looking to see how safe and     feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct     stenosis.   "
133072|NCT01543152|"     The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral     load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.   "
133038|NCT01543594|"     The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a     fundamental discovery to treat rheumatic patients whose disease appears to be refractory to     conventional therapy. These biologic drugs have been registered for human therapy from a few     years, thereby the investigators miss long-term data for safety and efficacy. Aim of this     study is to register all the clinical data of patients with rheumatoid arthritis and     spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term     safety and efficacy in the real life.   "
133039|NCT01543581|"     The primary objectives of this study are to assess, using Mohs micrographic surgery (MMS) at     the end of treatment, the efficacy (primary) and safety (secondary) of vismodegib compared to     placebo in the oral adjunctive pre surgical treatment of basal cell carcinoma. A secondary     objective is to assess how often and in what types of lesions does pre surgical treatment     with vismodegib result in complete eradication of the tumor.   "
133040|NCT01543568|"     50 Patients with recalcitrant exudative age-related macular degeneration with a history of     retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and     subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of     ranibizumab.   "
133041|NCT01543555|"     Patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular     complications. Statins have shown to lower cholesterol levels and reduce cardiovascular     events in other scenarios. The objective of this study is to explore the effects of     atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal     Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo     noncardiac surgery.   "
133042|NCT01543542|"     Helical tomotherapy is a novel radiation treatment machine that combines two existing     technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy     imaging of the body. This new machine can potentially allow radiation treatments to be     focused more precisely, and delivered more accurately than with existing radiation machines.     In this study, helical tomotherapy will be used to provide radiation treatments (whole brain     radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to     the brain. In addition, the individual spots of cancer (metastases) in the brain will be     treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The     purpose of this study is to determine the effectiveness of whole brain radiation with lesion     boosting with the helical tomotherapy machine.   "
133043|NCT01543529|"     This single-center, randomized, double-blind, four-period crossover study will investigate     the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy     volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose     of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and     alcohol, and placebo to RO4917838 and non-alcoholic drink.   "
133047|NCT01543477|"     The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA),     neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with     Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The     other key objective of this study is to obtain information on adverse drug reactions (ADR)     associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation     and data on long term use.   "
133048|NCT01543464|"     The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance     the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.   "
133049|NCT01543451|"     The main objective of this study will be to obtain data on the efficacy of elsiglutide in     preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving     5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.   "
133050|NCT01543438|"     The goal of this project is to develop the content and delivery platform that electronically     distributes mobile video discharge education for underserved populations and to demonstrate     utilization, satisfaction, and improved health outcomes.   "
133051|NCT01543425|"     Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in     maintaining homeostasis. The literature reports that pain in patients treated with opioids,     significant changes are taking place in this axis with a collapse in hormone concentrations     that are correlated with the decline on tests of quality of life and psychological testing.     The investigators hypothesis is that this endocrinopathy could also be present in patients     treated for neuropathic pain with other drug classes as opiates (antidepressants,     antiepileptics), and may explain, at least in part, the impairement of the quality of life of     these patients.   "
133052|NCT01543412|"     No validated second-line chemotherapy for the treatment of locally advanced/metastatic     pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or     Oxaliplatin)-based regimen.      Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was     reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI)     which could be useful even as second-line chemotherapy.      An exploratory study in this setting seem warranted.   "
133053|NCT01543399|"     The interruption of the secretion of sex steroids occurring during menopause, causes a change     in vascular pattern at various levels. As a result, several agencies have side effects that     interfere with women's health. The use of hormone replacement therapy has contributed to the     improvement in these effects. In previous studies the investigators showed the effect of sex     steroids in premenopausal women in the conjugated equine estrogens, medroxyprogesterone     acetate and tibolone in menopausal women, on the central retinal arteries. The aim of this     study is to evaluate the effects of Tibolone in Flow-Mediated Dilatation of the brachial     artery.   "
133054|NCT01543386|"     The aim of this study is to determine if an oral loading-dose of curcumin can improve     vascular endothelium reactivity in patients with moderate cardiovascular risk   "
133055|NCT01543373|"     The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting     Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent     (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence     Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total     Stent Struts Per Cross Section) score ≤ 0.3.   "
133059|NCT01543321|"     Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of     abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least     three months. This important public health issue arises for 15-20% of patients treated with     neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and     seriously impacts the patients' quality of life. In over 50% of cases, it is     irreversible-that is to say that he will persist despite discontinuation of the offending     drug.      Risk factors have been described: the age and female gender are established, a higher dosage     of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia are     likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or     powerful, longer term use of corrective treatments including anticholinergics are still     discussed.      Apart from preventive treatment, which consists in using antipsychotics as being coerced,     support is disappointing: the etiological treatment, which is to stop the offending     antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late     irreversible. Must still have the possibility to interrupt the treatment, which is usually     impossible in the risk of decompensation of the mental illness for which the neuroleptic was     prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme cases,     because it is not without risk, in terms of morbidity and mortality. So it's the medication     that is most often offered: many drugs have been proposed, a direct result of the     multiplicity of neurotransmitter systems implicated.      However, in the vast majority of cases, this approach is disappointing not to say     ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®.     Empirically, neurologists specializing in pathology of the movement are almost unanimous: its     efficiency is very good, with good tolerance. Some preliminary studies have reinforced this     impression. However, their level of evidence remains low and that is why the investigators     propose to implement a prospective multicenter clinical trial, double-blind with placebo     which will include two groups of 27 patients.   "
133060|NCT01543308|"     The protein composition of HDL is complicated. The investigators have identified 40 distinct     proteins associated with HDL by proteomics technology, and these proteins have been confirmed     to be related to the function of anti-inflammation, anti-oxidation, improvement of     endothelial function, inhibition of thrombosis and so on. And the investigators also found     that the levels of some proteins in HDL changed in patients with coronary heart disease,     compared with the healthy control group.      So, this study is to conduct in the two following aspects: enlarge the sample size to verify     the preliminary results to find new research ideas of pathogenesis and biomarkers for     coronary heart disease; and study the changes of HDL protein composition in patients with     coronary heart disease before and after statins treatment using proteomics technology in     order to find the mechanism of statins pleiotropic effects and indicators for evaluating the     treatment effectiveness.   "
133061|NCT01543295|"     This study has been designed to evaluate the performance of the Chembio Diagnostics Systems,     Inc. DPP® Syphilis Screen and Confirm rapid test. The device is intended to qualitatively and     simultaneously detect the presence of antibodies to Non-treponemal and Treponema pallidum     antigens in whole blood (capillary and venous), serum or plasma.   "
133062|NCT01543282|"     This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles in     consecutive patients.      Summary      Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration     (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies     comparing them regarding efficacy and feasibility are lacking.      Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of     the conventional 22 G compared with the 25 G needle.      Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for     inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant     coagulopathy (APT < 50% or platelets < 50000/mm3), use of warfarin or other anticoagulants,     use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent     and pregnancy or suspected pregnancy will be excluded.      Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to     compare proportions. Continuous variables will be compared using Student´s t test. A     two-tailed P values of less than 0.05 will be considered statistically significant. The     diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity,     specificity, positive predictive value and negative predictive value. An expected rate of 85%     diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a power     of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15%     difference in the rate of diagnostic yield.   "
133063|NCT01543269|"     This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1,     following oral administrations in healthy volunteers.      The study shall be divided into four plans as given below:        1. Plan I: Single dose escalation trial        2. Plan II: Multiple dose escalation trial        3. Plan III: Food effect trial.        4. Plan IV: Gender Effect trial.      The safety and tolerability shall be evaluated using physical examinations, Standard     laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG)     and thyroid scanning. Spontaneously reported and solicited adverse events will also be used     for safety parameters.   "
133064|NCT01543256|"     The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS)     to plastic stents for the treatment of benign biliary strictures secondary to chronic     pancreatitis as it pertains to stricture resolution rates, complication rates and number of     ERCP procedures during 24 months.      Statistical testing will be performed to determine if the rate of stricture resolution for     the metal stent is non-inferior to the plastic stent group.   "
133065|NCT01543243|"     This study aims to examine        1. the feasibility        2. immediately        3. long term effects on postural control and strength of mechanical SR-WBV intervention in          a frail elderly population.   "
133066|NCT01543230|"     The primary objective of this investigation is to evaluate survivorship at ten years. For     this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a     constant 1% per year.   "
133067|NCT01543217|"     The aim of this study is to reduce the number of subsequent hospital admissions and/or     emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary     disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM)     program compared to standard discharge instructions and planning.   "
133068|NCT01543204|"     This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who     have lost a satisfactory response to adalimumab.   "
133069|NCT01543191|"     The purpose of this study is to determine whether PUR118 is safe and tolerable in a     population of subjects with Cystic Fibrosis.   "
133070|NCT01543178|"     This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550     mg three times a day in patients with IBS with diarrhea who respond to initial treatment of     rifaximin 550 mg three times a day.   "
133075|NCT01543113|"     Background: Metastatic melanoma has a devastating prognosis and is one of the top causes of     cancer death in young patients. Until now, available therapies were few and unreliable, but     recent understanding of melanomas' molecular pathways has improve their classification and     new clinical strategies have been proposed.      Initial studies showed that B-Raf/N-Ras mutations (respectively V600E and Q61) are the most     frequent alteration being present in 70 to 80% of melanomas, characterizing non Chronic     Sun-induced Damage skins (CSD). These include Superficial Spreading Melanomas (SSM) and     Nodular Melanomas (NM). Other studies showed that c-Kit mutations are presently the     predominant activating mutation (20 - 40 %) in Acro-Lentiginous Melanomas (ALM), Mucous     Melanomas (MM) and in melanomas arising on CSD skin. c-Kit mutation pattern is more complex     with four exons being affected leading to different mutations, which incidence and biological     impact are less documented.      BRAF/NRAS genetics alterations drive constantly cell growth, being thus attractive targets.     Spectacular results have indeed been obtained with the BRAF inhibitor that targets the V600E     BRAF-mutated form. Data from GIST disease revealed that the different c-Kit mutations     modulate differently c-Kit function and the response to targeted therapies.      Because c-Kit targeted therapy is a critical clinical issue, the investigators aimed to     identify the most frequent mutations present in our population to propose appropriate     screening test and adapt the therapy.      Methods: 250 melanoma samples corresponding to an homogeneous white-Caucasian population     (Brittany, France) will be screened. c-Kit exons 11, 13, 17 and 18 will be sequenced (direct     sequencing and pyrosequencing when possible). c-Kit copy number will be quantified by q-PCR     and level of c-Kit determined by immunohistochemistry (IHC, CD117). Samples will also be     analyzed for B-Raf mutations in codon 464, 466, 469 and 600, and for N-Ras mutations in codon     12, 13 and 61 (Pyrosequencing).      Expected Results:      Taken together, the investigators anticipate that the present genetic analysis of the tumours     from patients with advanced melanoma will first document the type and frequency of cKit     mutations, will confirm or not that BRAF, NRAS and cKit mutations are mutually exclusive and     document their repartition in the melanomas sub-types. Finally this study will clue     researchers in to how well patients will respond to a therapy that targets the     growth-promoting proteins BRAF/NRAS and cKIT.   "
133076|NCT01543100|"     Blood circulating endothelial cells (CEC) and microparticles (MPs) are described in the     literature to be associated with vascular failures and dysfunction that reflect     neo-angiogenesis and risk of thrombosis, respectively. There a few number of CEC in healthy     patients although they significantly increase in several cancers including myeloma. However,     no study explored to date a correlation of CEC and/or circulating endothelial progenitors     (CEP) and MPs with the tumoral growth of monoclonal gammopathy. On the other hand, there is     no study measuring the CEC and CEP directly in the bone marrow. The investigators aim is to     evaluate these 2 original features in patients with monoclonal gammopathy: monoclonal     gammopathy of undetermined signification (MGUS) and myeloma. This is a preliminary     multicentric study.   "
133077|NCT01543087|"     This study is to assess the longevity of immune response in adolescents for approximately 48     months after receipt of a primary series of bivalent rLP2086 vaccination, which is then     followed by a booster dose and an assessment of immune response for 12 or 26 months post     booster vaccination.   "
133078|NCT01543074|"     This pilot, three-week study will help scientists understand more about how the foods people     eat can modify histone deacetylases, enzymes the body produces naturally. Broccoli sprout     extract (BSE) and garlic oil are thought to modify these enzymes. The purpose of this study     is to see if taking broccoli sprout extract alone, garlic oil alone, or broccoli sprout     extract and garlic oil together, can decrease the action of histone deacetylase (HDAC) and     turn on genes in white blood cells. There will be 80 people in this study.   "
133079|NCT01543061|"     The objectives of the investigation will be to assess the effect of the repeated usage of a     new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with     contact lens related comfort problems and to quantify any potential benefit.   "
133080|NCT01543048|"     CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are     subsequent to a persistent HPV infection and are classically treated by conization.     Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2     years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high     risk women who might develop cervical cancer. Colposcopy and cytology have been recommended     since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However,     DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value,     while specificity and positive predictive value remain average. Other HPV markers like     genotyping, viral load and integration begin to be used in screening but have not been     investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict     CIN2/3 recurrence after conization. The primary objective is to describe HPV expression     (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up     period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral     load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared     to the other clinical and virological risk factors.   "
133081|NCT01543035|"     Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein (LDL)     cholesterol and reduced high-density lipoprotein (HDL) cholesterol levels, is common in     HIV-infected individuals, and has been associated with HIV infection itself and     antiretroviral therapy (ART). These abnormalities are well-established markers of     cardiovascular (CVD) risk in the general population. Studies have suggested an increased risk     of CVD associated with ART exposure over and above that conveyed by traditional     cardiovascular risk factors. In HIV population to reduce lipid parameters, the most usual     clinical strategy remains to add a statin treatment.      Recent studies suggested ART switch can represent an interesting alternative to statins to     reduce lipid plasma levels.      The purpose of this study is to evaluate the frequency with which the replacement of LPV/r     (lopinavir/ritonavir), ATZ/r (atazanavir/ritonavir), DRV/r (darunavir/ritonavir) or EFV     (efavirenz) by ETR (Etravirin) in dyslipidemic patients with suppressed viremia would obviate     the necessity to administer statins.      A prospective, phase III study in which the statin treatment of dyslipidemic HIV patients on     antiretroviral drugs (ARVs) will be interrupted during 4 weeks is proposed.      At week 4, patients qualifying for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) will     replace EFV, LPV/r, DRV/r or ATZ/r by ETR. The proportion of patients not qualifying anymore     for a statin treatment at 12 weeks (i.e. after 8 weeks of ETR treatment) will be determined.     Additionally, the lipid level changes will be assessed at 12 weeks. Inflammatory markers will     be measured at baseline, at drug switch and at the end of the study      Study drug will be provided by the drug manufacturer (Janssen-Cilag, AG). Compliance for     study drug will be done at week-4 and week-12, Returned study medication will be counted and     the amount notified on the Case Report Form (CRF).   "
133082|NCT01543022|"     The Counter Pulsation Device (CPD) System 'Symphony' is intended to provide counter pulsation     therapy for up to thirty (30) days to patients with chronic heart failure who have persistent     worsening of their condition despite optimal medical therapy. Patients will be in New York     Heart Association (NYHA) Class IIIb or IV heart failure and have exhausted all medical or     surgical options.   "
133083|NCT01543009|"     The aim of this study is to determine if local application of heat increases the probability     of insertion of peripheral venous catheter at the first attempt, reduces the time needed to     obtain cannulation and maintains the analgesic effect of Emla in children undergoing     peripheral venous cannulation and previously treated with local analgesia with Emla.   "
133084|NCT01542983|"     Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect     their mood, their memory and their quality of life. The investigators are testing whether it     is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start     of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and     quality of life.   "
133085|NCT01542970|"     The incidence of allergic disease has increased worldwide during the last decades. Initially,     a lot of effort has been put in elucidating which of the known risk factors commonly     associated to the development of allergic disease early in life was the cause of this     increase. Studies showing a reduced incidence of allergic disease in the former socialist     countries in comparison to countries with a Western lifestyle have shown that risk factors     as allergen exposure, environmental pollution and tobacco exposure are also present in     societies with a less affluent lifestyle. This suggests the disappearance of factor     protecting against the development of allergic diseases in affluent environment.The     development of allergic diseases begins during the first year of life with eczema, both     non-IgE- and IgE-associated, and food allergy, progressing during childhood with the     development of asthma bronchiale, also both non-IgE- and IgE-associated, and later     development of allergic rhinoconjunctivitis, i.e. the atopic march. The immune system of the     neonate is influenced by maternal immunity, both via the placenta and breast milk. Thus, the     immunological interaction between the mother and her offspring is close during pregnancy and     lactation. The association of cord blood IgE levels with maternal but not paternal atopic     heredity, may depend on a possibly stronger placental Th2 shift in atopic mothers. Thus,     factors influencing/protecting against the development of allergic disease early in life,     would be important already during pregnancy, birth and early postnatal life. Two major     hypotheses have been assessed during the last decade: Proper microbial stimulation, including     the establishment of the gut flora in infancy and the relationship between low omega     3-polyunsaturated fatty acids in the western diet and the incidence of allergic disease.      This is a double blind randomized study. Families with at least one parent/sibling with     clinical symptoms/history of allergic disease will be invited to participate in this study.     Pregnant mothers will be included in the study at the 20th week of gestation. They will be     randomized to 4 study groups, one will receive placebo capsules, the second will receive     omega-3 PUFA supplementation and placebo regarding L. reuteri, the third will receive L.     reuteri and placebo regarding omega-3 PUFA and the fourth group will receive both omega-3     PUFA and L. reuteri supplementation. Omega-3 supplementation will be given to mothers from     pregnancy and lactation while L. reuteri will be given to the mothers during pregnancy and     later to the children during the first year of life.The children will be clinically followed     by an allergy nurse regularly. Questionnaires regarding data on environment, siblings, pets,     breast feeding, smoking exposure, upper respiratory and other infections and clinical     symptoms of allergic disease will be filled regularly. Skin prick tests (SPTs) will be     performed in the children at 6 and 12 months with milk, egg, wheat, peanut and cat. At 24     months, timothy and birch allergen extracts will be added. A pediatrician will assess the     children at 24 months of life and whenever it is needed during the study period. Dietary     habits will be assessed during pregnancy (25th gestational week) and 6 months after child     birth. Blood samples in the children will be taken from cord blood and at 6, 12 and 24 months     of life. Maternal blood samples will be taken at 20th weeks of gestation and at child birth.     Milk samples will be collected 1-4 days after partus and monthly during the first 4 months of     lactation. Maternal gastrointestinal function will be addressed by validated diary cards.     Saliva from the children and fecal samples from mother and child will also be collected     according to the following protocol.   "
133086|NCT01542957|"     The purpose of this study is to determine the efficacy of a brief psychological intervention     focused on the personal dilemmas identified for each depressive patient. For that, this     intervention is combined to group cognitive therapy (an already proven efficacious format)     and compared to cognitive individual therapy.   "
133087|NCT01542944|"     The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar     version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem     cells from normal sibling donors for allogeneic stem cell transplantation.   "
133088|NCT01542931|"     Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally     advanced or aggressive cancers, and to improve the chance of eradication of the locoregional     lesions by radical surgery and/or radiotherapy. However, there are still debates on the     clinical value of induction chemotherapy for patients with advanced and resectable oral     squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of     TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with     locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival     rate, local control, and safety.   "
133089|NCT01542918|"     This is a Phase I study, which means that the goal is to see if the study treatment is safe.     The purpose of this study is to test the safety of Lenalidomide at different dose levels, and     to test the safety of Lenalidomide alone or in combination with Rituximab (also known as     Rituxan®).   "
133090|NCT01542905|"     The purpose of this study is to examine clinical and neuropsychiatric effects of Korean Red     Ginseng and examine changes in brain structure, function and metabolites. A total of 60     healthy volunteers will be recruited and will be assigned to either Korean Red Ginseng group     or placebo group. Individuals will be examined through clinical assessment,     neuropsychological function tests and neuroimaging.   "
133091|NCT01542892|"     Several trials have found that nutritional supplementation can elicit an increased rate of     skeletal muscle protein synthesis following a single bout of exercise in both young and older     individuals. However, there have been no studies that have investigated if nutritional     supplementation and exercise can cause a sustained increase in physical functioning and fat     free mass, particularly in older adults with functional limitations. This study will compare     the effects of a nutritional supplement versus a placebo on exercise training induced changes     in physical functioning older adults who are at risk for mobility disability.   "
133092|NCT01542879|"     A research study on the diagnosis of spread of disease for children who have been diagnosed     with solid tumors using a new whole body imaging technique and a new MR contrast agent     (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a     child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron     Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG)     scanning. The purpose of this study is to determine if newer imaging tests referred to as     whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of     the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The     advantage of the new imaging test is that it is associated with no or significantly reduced     radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole     body MR and PET/MR will be compared with that of the conventional, standard imaging studies     for tumor detecting.   "
133093|NCT01542866|"     This is a prospective pilot study to evaluate the usability and applicability of a self     monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely     monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in     disease status.   "
133094|NCT01542853|"     MRI has shoved little correlation with the clinical finding during treatment of     spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good as     MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better in     predicting residual disease in patients with spondylodiscitis.      Preliminary study.   "
133095|NCT01542840|"     The purpose of this study is to compare injecting local anesthetic (numbing medication) in     different patterns around a major nerve in the leg. Patients who undergo surgery to the lower     leg and/or foot are usually offered the option of a nerve block to help with pain control     after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a     nerve or nerves that provide sensation to the area where surgery will be performed. The local     anesthetic (numbing medication) numbs up the area where the surgery is performed and helps     decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can     be injected in various patterns by a nerve, such as in one spot by a nerve or completely     surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or     will injected in a way that will split the sciatic nerve into the two component nerves that     make it up, the tibial and sciatic, and surrounds each nerve.      The hypothesis is that subjects in the group that local anesthetic is injected in a pattern     that separates the sciatic nerve into the two component nerves may have a faster onset time     of regional anesthesia and block success than subjects in the group that have the local     anesthetic injected at around the nerve.   "
133096|NCT01542827|"     Topical menthol gels are classified 'topical analgesics' and are used to relieve aching and     tenderness of muscles and joints. However, double-blind randomized controlled trials are     lacking. Here the investigators examine - in a double-blind randomized controlled cross-over     trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol     scent) on neck pain.   "
133097|NCT01542814|"     This image-acquisition study is designed to acquire the study image data and establish and     document the clinical findings for each subject. The acquired data will be used to support     FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital     Mammography) and future regulatory submissions.   "
133098|NCT01542801|"     -  For the prevention of spontaneous bacterial peritonitis (SBP) in patients with liver          cirrhosis, norfloxacin 400mg per day is a standard regimen.        -  Ciprofloxacin 750 mg per week is also known to be effective for prevention of SBP. In          addition, ciprofloxacin once weekly administration is more convenient and less costly.        -  Therefore ciprofloxacin once weekly could be more useful if the the efficacy is          comparable to norfloxacin once daily.        -  This study aims to prove ciprofloxacin once weekly administration is as effective as          norfloxacin once daily administration for the prevention of SBP in cirrhotic patients          with ascites.   "
133099|NCT01542788|"     This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection     who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants     were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to     match SOF+placebo to match RBV. Randomization was stratified by presence/absence of     cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.   "
133100|NCT01542775|"     The purpose of this study is to examine the effects of exercise on diverse cardiometabolic     risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus     (T2DM).   "
133114|NCT01542593|"     Proper selection of ureteral stent length might help in reducing comorbidities associated     with ureteral stenting, currently there is no standardized way of measuring ureteral length.      Measurement of ureteral length according to Computed Tomography (CT) scan might provide     useful information when selecting the length of a ureteral stent. Our aim in this study is to     compare ureteral measurements using CT scan and measurement of actual ureteral length     measured during ureteral stenting.   "
133101|NCT01542762|"     Currently, guidelines and clinical practice differ considerably with respect to use of     anticoagulant treatment during cast immobilization of the lower leg. Trials that have been     carried out were aimed at efficacy only, had small sample sizes and therefore mainly used     asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could     not be established, hence the current controversy. In the proposed study the investigators     will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the     investigators will follow subjects with an adverse event for a longer period, during which     the investigators will assess the long term sequelae of these events. Lastly, the     investigators will determine high risk groups that will benefit most from anticoagulant     treatment.      Objective: Comparative effectiveness research to determine cost-effectiveness of two existing     policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster     cast immobilization following surgical or conservative treatment. In addition the     investigators will investigate personalized prophylaxis based on genetic and acquired risk     factors.   "
133102|NCT01542749|"     The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is     based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In     addition to calculating human blood volume it is hypothesized that measurement of the     dilution of the tracer can also yield an accurate measurement of total body albumin.   "
133103|NCT01542736|"     To study the efficacy of the combination of reduced dose craniospinal radiation (reduced from     standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine     administration for metastatic classical histology medulloblastomas and high-risk     supratentorial PNETs and metastatic PNETs.   "
133104|NCT01542723|"     Currently, guidelines and clinical practice differ considerably with respect to use of     anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were     aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic     thrombosis as endpoint. From these trials an overall risk benefit-balance could not be     established, hence the current controversy. In the proposed study the investigators will use     relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators     will follow subjects with an adverse event for a longer period, during which the     investigators will assess the long term sequelae of these events. Lastly, the investigators     will determine high risk groups that will benefit most from anticoagulant treatment.      Objective: Comparative effectiveness research to determine cost-effectiveness of two existing     policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the     knee. In addition the investigators will investigate personalized prophylaxis based on     genetic and acquired risk factors.   "
133105|NCT01542710|"     The purpose of this study is to compare 2 fixed combination medications in intraocular     pressure lowering.   "
133106|NCT01542697|"     intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and     analgesic consumption in postoperative period following laparoscopic cholecystectomy.   "
133107|NCT01542684|"     The goal of this clinical research study is to learn if the combination of azacitidine and     GM-CSF can help to control MDS. The safety of these drugs will also be studied.      Azacitidine is designed to block certain proteins that stop the function of tumor-fighting     genes. By blocking the bad proteins, the tumor-fighting genes may be able to work better.      Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white     blood cells. This may help to fight infections.   "
133108|NCT01542671|"     The primary objective of the study is to evaluate the effectiveness of tailored lifestyle     intervention in primary care by comparing changes in the primary measure of weight and body     mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and     fruit/vegetable servings within the two arms (intervention and control) of the study. It is     hypothesized that the intervention cohort will demonstrate greater reductions in body weight,     body neglect, and fat calories consumed and greater increases in physical activity and     fruits/vegetable servings after two years compared to the control cohort. The study also aims     to evaluate and compare the cost of intervention for purpose per each unit of measure lost     between the two arms of the study as a secondary objective. The cost of intervention will be     evaluated as it relates to study replication.   "
133109|NCT01542658|"     This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy     (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative     variables and short-term outcome of RALM and TLM patients.   "
133127|NCT01542424|"     This trial is conducted in Europe. The aim of this trial is to investigate efficacy and     safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects     with type 1 or 2 diabetes mellitus.   "
133110|NCT01542645|"     The primary aim of this randomized, double-blind study is to examine the effect of a single     intraoperative dose of methadone on postoperative pain and analgesic requirements in patients     undergoing cardiac surgery with cardiopulmonary bypass. These patients will be compared to     subjects receiving a standard dose of the traditional intraoperative opioid (fentanyl).     Secondary outcome measures to be assessed will include standard recovery variables (such as     length of postoperative intubation, ICU length of stay, incidence of nausea or vomiting,     level of sedation). In addition, patients will be assessed for the development of chronic     postoperative pain.   "
133111|NCT01542632|"     A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose     schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare     the immunogenicity of different dose schedules of the vaccine.      Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of     viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then     on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue     neutralizing antibodies in serum were obtained at baseline [during the screening period or on     day of vaccination (Day 0)], then on Days 30, 90 and 120.      The entire duration for each individual subjects participation was approximately 5 months     including recruitment and collection of data for primary outcomes (through Day 120).   "
133112|NCT01542619|"     This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation     cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in     comparison to placebo.   "
133113|NCT01542606|"     This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes     into contact with vaginal secretions having an elevated pH level   "
133263|NCT01540643|"     The purpose of this registry is to obtain case reports of physician experience with the     Spiral-Z® graft under routine clinical care.   "
133115|NCT01542580|"     The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system     utilizing offset on either the tibial component, femoral component, or both in terms of the     restoration of mechanical alignment, clinical outcomes and survivorship.   "
133116|NCT01542567|"     This study is designed to test the effectiveness of diclofenac suppositories in the     prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.   "
133117|NCT01542554|"     The purpose of this study is to investigate the effect of low glycaemic diet on blood glucose     control in Chinese type 2 diabetic patients.   "
133118|NCT01542541|"     Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG)     that is taken-up by active cells such as cancer cells. This contrast can then be seen in the     body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can     produce false positive signals from the colon. Our hypothesis is that much of this signal     comes from bacteria that are present in high concentrations in the colon. If this is the     case, using an antibiotic to suppress the activity of bacteria may improve the ability of     PET-CT to distinguish abnormal cells from normal cells in the colon.   "
133119|NCT01542528|"     The investigators are conducting this randomized trial to determine if IBBS (Integrated     Brain, Body, and Social)intervention is an effective treatment for ADHD (attention Deficit     Hyperactivity Disorder) in two culturally distinct settings; Hamden, Connecticut and Beijing,     China. A subgroup of the children in Hamden will also participate in a brain imaging study     before and after IBBS.      IBBS combines computer-presented brain exercises with a physical education curriculum, all of     which is designed to be fun, as well as to enhance sustained attention, inhibitory control     and other executive capacities.      IBBS is a school-based program in which groups children (composed of children with ADHD,     children at risk for ADHD, and typically developing children) alternate between a classroom     setting and the gymnasium four days a week for 15 weeks. These mixed age groups will be     composed of children with ADHD, children at-risk for ADHD, and typically developing children.     Although IBBS takes place in a group setting, the computer game component individualizes     instruction to maximize benefit for each child.   "
133120|NCT01542515|"     Hypothesis:      The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for     the surgical treatment of basal joint arthritis of the thumb.      A variety of surgical procedures have been developed for the treatment of basal joint     osteoarthritis of the thumb. Problems with persistent pain and poor function have been     reported to some degree for each of these procedures. Using the concept of an implant acting     as a spacer and stabilizer the investigators proposed and implemented a novel surgical     technique using allograft knee meniscus as a biologic implant for the treatment of basal     joint arthritis of the thumb.   "
133121|NCT01542502|"     This will be a randomized, double-blind, crossover pilot study to measure the safety and     feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart     failure with preserved ejection fraction.   "
133122|NCT01542489|"     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of     Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events     in insulin treated subjects with type 1 or type 2 diabetes.   "
133123|NCT01542476|"     This study is conducted in Europe. The aim of this study is to assess the well-being of     patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type     2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting     basal insulin analogue is needed.   "
133124|NCT01542463|"     This study conducted in Europe. The aim of this study is to evaluated the use of insulin     detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.   "
133125|NCT01542450|"     This trial is conducted in Japan. The aim for this trial is to investigate the     pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects     with type 1 diabetes mellitus.   "
133126|NCT01542437|"     Patients with stage IIIB and IV lung adenocarcinoma and progression to first-line     chemotherapy were enrolled to receive afatinib 40 mg/day. Mutational EGFR and HER-2 status     were assessed by RT-PCR. HER2 amplification was evaluated by FISH. Plasma HGF levels were     measured by ELISA before and 2 months (mo) after the start of treatment. We assessed changes     in serum HGF levels and their association with objective response rate (ORR), PFS and overall     survival (OS).   "
133128|NCT01542411|"     This study evaluated the effect of anticoagulant treatment on the live-birth rate in women     with a history of at least two continuous unexplained miscarriages or thrombophilia. It also     compared two methods of treatment with aspirin and aspirin plus heparin.   "
133129|NCT01542398|"     The main research question of the study is whether a family-based, life-skills focused     psychosocial intervention is effective in reducing psychological distress and stigma and     improving inter-personal relations and functioning among war-affected children in the     Democratic Republic of Congo.   "
133130|NCT01542385|"     The purpose of this research project is to improve how we treat heart attacks. The study will     assess whether it might not be better to wait a few hours before implanting the coronary     stent into the coronary artery rather than implanting it immediately, in order to allow the     drugs to completely dissolve the clot. This might help to reduce the risks of the clot     migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able     to reduce the size of the infarction and reduce the risk of suffering from heart failure     following a heart attack.   "
133131|NCT01542372|"     This project aims to investigate the efficacy of two models to treat Posttraumatic Stress     Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is     giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine     reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those     patients who still have PTSD, the second step is either another medication or a culturally     sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients     will improve in both models, but more so in the the CBT model.   "
133132|NCT01542359|"     The proposed study will compare a well defined and integrated yoga practice (postures/breath     control/meditation) to a conventional exercise program in reducing hypertension. The expected     outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial     stress, and the autonomic system in individuals with pre- and Stage I hypertension. The     information gained in this study will have a positive impact by providing critical     preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial     on the effects of yoga on individuals with hypertension.   "
133133|NCT01542346|"     This is a double blinded randomized study investigating if subcutaneous adaption has an     impact on cosmetic outcome after Caesarean delivery.   "
133134|NCT01542333|"     RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory     may help doctor learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms     tumor.   "
133135|NCT01542320|"     The purpose of this study is to understand how a probiotic might change the immune response     of healthy infants.   "
133136|NCT01542307|"     This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in     acute migraine headache.   "
133137|NCT01542294|"     The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin     combination chemotherapy based on the adverse events and survival period by performing a     phase I/II study of this combination in patients with D2 resection of gastric cancer.   "
133138|NCT01542281|"     1. To determine whether a combined nutritional support program and exercise-based          prehabilitation is superior to nutritional support alone in increasing functional          recovery and reducing post-operative morbidity after surgery for HPB malignancy.        2. To understand which measures of immediate surgical recovery are sensitive to          prehabilitation interventions and predict change in later outcome measures.   "
133139|NCT01542268|"     The purpose of this study is to determine the therapeutics effectiveness of oral     pentoxifylline treatment in patients with IBS.   "
133140|NCT01542255|"     SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low     Dose Vinblastine, Cyclophosphamide, and Dacarbazine.      Patients with measurable metastatic melanoma are eligible. All patients will be treated as     outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be     treated continuously, until evidence of progression of disease, or for up to two cycles     following disappearance of all disease. A cycle will be defined as three weeks of continuous     therapy with a one week rest.   "
133141|NCT01542242|"     Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in     patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive     effect and has been associated with weight loss in patients with type 2 diabetes. Liraglutide     use in the treatment of PWS is limited to one case report by Cyganek et el (See attached     Citation). In this case report, the subject showed improvements in hemoglobin A1c and body     weight over 14 weeks.      The investigators plan to examine the use of liraglutide in a single subject with Prader     Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical     parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid     control.   "
133142|NCT01542229|"     As in the general population, there is no clear standard of care within Veterans Affairs     Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with     severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic     stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among     Veterans and this symptom presentation clearly exacerbates the overall course and severity of     mental illness. This study is significant in that it proposes to establish the efficacy of a     frontline exposure based intervention for posttraumatic stress disorder (PTSD), Prolonged     Exposure, for improving critical clinical, quality of life, and cost outcomes among Veterans     with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it is anticipated     that these data will establish a much needed clinical course of action for what is considered     a vulnerable yet highly underserved patient population.   "
133143|NCT01542216|"     With the increased success in breast cancer therapies, survivors develop unhealthy changes in     body composition, such as muscle loss and fat gains, which lead to increased risk of     cardiovascular disease and diabetes in survivorship. This study will examine the effects of a     nutrition, cardiovascular and strength exercise program compared with a yoga program     (representing usual care) on body composition and metabolism in recently diagnosed breast     cancer patients. Nutrition and exercise may improve various body composition and metabolic     parameters, which may improve quality of life in survivorship, reduce risk of recurrence and     reduce the risk of developing cardiovascular disease and diabetes in survivorship.   "
133144|NCT01542203|"     This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This     study is designed to measure drug concentrations in the blood of 18 female breast cancer     patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute     infusion) as part of standard medical care. Up to a total of 40 adult female participants     will be consented for the study at the cancer center. Eighteen of these participants are     needed to complete the study. The others will likely be screen failures. The participants     will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior     to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after     the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous     catheter will be removed when the participant is discharged from the cancer center on day 1.     The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have     the final 2 blood draws conducted. The participants must be treated with Doxorubicin and     Cyclophosphamide in order to participate in this pharmacokinetic analysis study.   "
133145|NCT01542190|"     The purpose of this study is to compare effects of preoperative and postoperative use of     topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.      Patients scheduled to undergo phacoemulsification will be randomized to receive either     topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo     group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group)     for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks     after surgery will be angiographic cystoid macular edema.   "
133146|NCT01542177|"     This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer     using an imaging test called positron emission tomography (PET). Hypoxia can influence how     pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy. The     use of PET scans to measure hypoxia may be better and simpler than the approaches used     previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA     (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic     cancer. Also as part of the study, a blood sample will be taken to study biomarkers     (substances in the body that may be important indicators of hypoxia and/or pancreatic cancer)     that may be useful in studying pancreatic cancer and hypoxia.   "
133147|NCT01542164|"     The overall purpose of this study is to examine the effect of calcium on fecal fat and energy     excretion.   "
133148|NCT01542151|"     This randomized clinical trial will examine if there are any differences between post-dates     inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the     evening for first-time mothers. Sleep and fatigue measures will be measured to see if they     differ by time of induction. Other measures will include the rate of births within 24 hours     of admission, length of labor, use of labor analgesics, and method of delivery.   "
133149|NCT01542138|"     Axillary hyperpigmentation is a frequent consultation in dark skin populations although its     exact prevalency is unknown. Currently, there are not studies about physiopathology and     treatment for this entity. The objective is to evaluate the depigmenting effect of topical 4%     niacinamide versus 0.05% desonide in axillary hyperpigmentation.      At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50     years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. No     hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9     weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as     Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.   "
133150|NCT01542125|"     The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation,     occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH),     this frequently performed procedure is currently done without anesthetic, making it a painful     and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a     relatively new effective and needle-free topical anesthetic. The investigators were     interested in examining its effectiveness in pain reduction in children undergoing Perc Pin     removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a     pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The     investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during     Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded,     randomized placebo-controlled clinical trial with 281 patients (140 patients each in the     Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children)     and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to     randomization and immediately after Perc Pin removal. Data was analyzed using a Student's     t-test and the Wilcoxon signed ranks test.   "
133151|NCT01542112|"     This new model to manage patient expectations was developed based on our international study     conducted in four countries. The model is designed to address the main issues that lie at the     core of initiatives to manage patient expectations and improve patient satisfaction. It is a     structured interventional set of activities, which gives the clinician an opportunity to meet     patient expectations and needs and thereby, improve patient satisfaction.      The interventional model comprise teachable-learnable communicative steps occurring between     the clinician and the patient which are: Gather information on the patient's expectations and     perception of the hospitalization, Respond, Provide relevant information and Document the     intervention.      The intervention includes all frontline care givers; however, most of the activities will be     done by the nursing staff. The set of activities will be executed by the nurses at three     separate periods of time during the patient's hospitalization: time of admission,     intermediate time and at time of discharge.      The study is based on the hypothesis that a structured interventional model will     significantly improve patient satisfaction during hospitalization.   "
133152|NCT01542099|"     The purpose of this study is to evaluate the effect site concentration of remifentanil     blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.   "
133153|NCT01542086|"     The investigators aim to compare the cost-effectiveness of CCTA and myocardial SPECT in     patients with intermediate pre-test probability of CHD. To this end, patients with     intermediate pre-test probability of CHD will be randomized 1:1 to either CCTA and myocardial     SPECT. The patients will be analyzed for cost and also, for outcome.   "
133154|NCT01542073|"     This is an open-label PET/CT (positron emission tomography/computed tomography) study to     investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of myocardial     infarction. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be     intravenously injected into myocardial infarction patients. Visual and semiquantitative     method will be used to assess the 68Ga-BNOTA-PRGD2 PET/CT cardiac images and compared to the     99mTc-MIBI SPECT myocardial perfusion images and the 18F-FDG metabolism images.   "
133155|NCT01542060|"     This study is conducted in Asia. The aim of this observational study is to collect efficacy     and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal     clinical practice conditions.   "
133156|NCT01542047|"     This study is designed to investigate the possibility that use of two similar but distinct     drugs used together in treatment of advanced cancer might prove less toxic than either agent     used alone, because dosages can be reduced for each agent. This is a phase I study that is     designed to measure the frequency and levels of specific side effects when Carboplatin and     Pazopanib are used in combination in advanced cancer patients. The possibility that     anti-tumor activity will occur is also going to be investigated.   "
133157|NCT01542034|"     To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of     submental fat (fat below the chin).   "
133400|NCT01538836|"     The purpose of this study is to determine whether consuming additional protein during calorie     restriction induced weight loss has beneficial or harmful effects on multi-organ (liver,     muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut     microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal     women.   "
133158|NCT01542021|"     Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone     levels in the body.      Degarelix is commonly given with radiation for prostate cancer, but less frequently with     surgery since there has been no proven benefit with this approach.      The investigators do not expect the patient to benefit directly from treatment with degarelix     since their prostate will be removed shortly after the drug is given. Instead, the     investigators hope to learn about how degarelix and other treatment that lowers your     testosterone effects prostate cancer cells and use this information to develop better     treatments in the future.   "
133159|NCT01542008|"     Bipolar disorder (BD) is a serious and chronic mental illness that is associated with     substantial impairment in quality of life and functional outcomes, high rates of suicide, and     high financial costs. In spite of a proliferation of treatments for BD, nearly half of     individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication     treatment adherence. Non-adherence with BD medication treatment dramatically worsens     outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it     has been suggested that adherence enhancement might work best if the intervention     specifically addresses factors that are important and modifiable for a specific individual.     In spite of the enormity of the problem, the literature on interventions to improve treatment     adherence is surprisingly limited. There is an urgent need for interventions to enhance     treatment adherence among BD patients that: 1) are at high risk for future treatment     non-adherence; 2) may not have access to or interest in long-term, high-intensity, and     specialized care; and 3) are flexible and patient-focused taking into account reasons for     non-adherence for a specific individual.      The proposed study is a first-ever RCT focused specifically on BD treatment adherence     enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial     intervention improves adherence and mental health outcomes compared to broadly-directed,     non-individualized education (EDU). The proposed project has the potential to greatly advance     the care of BD patients who are at greatest risk for poor health outcomes, with findings     expected to be generalizable across a variety of treatment settings.      Hypothesis 1: CAE will be associated with greater improvement in treatment adherence compared     to broadly-directed, non-individualized BD education (EDU).      Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.   "
133160|NCT01541995|"     The study aims to compare the value of contrast medium enhanced post mortem CT to classic     autopsy.   "
133161|NCT01541982|"     The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for     quality control in intensive care medicine.   "
133162|NCT01541969|"     The purpose of this study is to determine whether a new device delivering a sound-based     intervention (termed acoustic coordinated reset neuromodulation) has significant clinical     benefit for people with intrusive tinnitus. It is hypothesised that the particular pattern of     sound stimulation delivered by the device acts to break up patterns of synchronous nerve     firing in the brain that may be responsible for the sensation of tinnitus. We will also     measure brain activity in a subset of participants to determine if the intervention results     in changes in brainwave activity.   "
133163|NCT01541956|"     This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional     study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as     add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients     with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.   "
133164|NCT01541943|"     The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with     essential hypertension and hyperlipidemia   "
133165|NCT01541930|"     This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate     malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days     of treatment.      The clinical hypothesis is that the success rate is no worse than 70% in the population of     interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of     treatment, as assessed by the Study Investigator.   "
133166|NCT01541917|"     The purpose of this multi-site randomized clinical trial is to determine if an online coping     skills training program will produce superior improvements in pain and health-related quality     of life outcomes for adolescents with JIA relative to outcomes attained with reviewing online     educational information about JIA.   "
133167|NCT01541904|"     The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118     ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal     (SAC) and perennial (PAC) allergic conjunctivitis.   "
133168|NCT01541891|"     The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic     solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms     of mild-to-moderate dry eye syndrome.   "
133169|NCT01541878|"     Breast cancer is the most common malignancy affecting women. It is the second leading cause     of cancer related death in women in many parts of the world. Breast cancer also occurs in     men, accounting for nearly 1% of the total incidence. As a result of continuing research into     new treatment methods, women and men with breast cancer now have more treatment options, and     a better chance of long-term survival than ever before.      The primary treatment for breast cancer is surgery. Early stage breast cancer, defined for     the purposes of this registry as newly diagnosed, clinical stage I to IV breast cancer with     no prior therapy for current disease, is often curable with surgery alone. Reports from the     National Surgical Adjuvant Breast and Bowel Project (NSABP) and the European Organization for     Research and Treatment of Cancer (EORTC) longitudinal trials have explored the efficacy of     various surgical techniques as primary treatment of early stage breast cancer1-7. These     studies include 20 years of follow-up data that have not shown any significant differences in     overall survival or in rates of distant recurrences in women who underwent breast-conserving     surgery with radiation therapy versus those who underwent mastectomy. The results of these     studies have supported the use of surgery as the standard breast cancer treatment practice     around the world.      Data have shown that regardless of the surgical procedure selected for the removal of the     primary tumor, micrometastases may be present and lead to the development of disease relapse.     In order to decrease the risk of recurrence, patients may receive various therapies. Systemic     treatments include chemotherapy and hormonal therapy. Local treatment, such as radiotherapy,     can also be used to eliminate malignant cells that remain in the breast, chest wall, or lymph     nodes after surgery.      The selection of systemic therapy is a complex process, which is based partly on prognostic     factors such as lymph node status, and predictive factors such as hormone receptor status. A     number of additional factors are emerging such as HER2/neu overexpression8-10, p53 status,     histological evidence of vascular invasion, and quantitative parameters of angiogenesis, but     these await confirmation by further research11. However, patient age, socioeconomic status,     and availability of treatment options are among a number of other factors that may play a     role in determining the type of therapy that a patient is offered.      Over the years, results from a large number of clinical trials have led to the development of     various guidelines for breast cancer therapy, including the Early Breast Cancer Trialists     Group (EBCTG) conferences in 199512 and 200013, the 2000 National Institutes of Health (NIH)     Consensus Conference14, and the 8th St Gallen meeting in 200315. Despite the overview     analyses and consensus recommendations, detailed information is lacking regarding the actual     use of the currently available breast cancer treatments. Furthermore, the reasons that     patients and physicians choose specific therapeutic regimens are not well understood.      With more than 1.2 million people worldwide diagnosed with breast cancer in 200116, and the     incidence predicted to increase, making appropriate treatment choices is critical to each     breast cancer patient's survival, well-being and quality of life. The plethora of available     scientific and lay information can result in a complex and arduous decision-making process     for the breast cancer patient and his/her health care provider(s). It is anticipated that     this registry will assist in the decision-making process by providing up-to-date information     about treatment patterns.      STUDY OBJECTIVES The purpose of the study is to collect, analyze, and disseminate data on     patients with stage I-IV breast cancer. The goal of this registry is to improve patients care     through a better understanding of treatment patterns and outcomes within individual     countries, geographic regions, and ultimately, worldwide.      Primary Objectives:        -  Characterize the clinical pattern of patients with breast cancer (clinical stage I-IV as          defined by the AJCC17).        -  Characterize existing and evolving practice patterns.        -  Assess patient disease free and overall survival outcomes.      Secondary Objectives:        -  Disseminate findings through publication in peer-reviewed scientific journals.        -  Provide supportive data to the development of standard therapies.        -  Analyze data and design ancillary studies to address unanswered clinical questions.   "
133170|NCT01541865|"     The Study objective is to assess the performance of the Vessix V2 Renal Denervation System     for the treatment of uncontrolled hypertension using an innovative percutaneous Radio     Frequency (RF) balloon catheter renal denervation device.   "
133233|NCT01541033|"     The purpose of this study is to identify biomarkers in this subset of autism patients, design     a protein based assay system for screening serum for these biomarkers and confirm that these     serum antibodies are still present at one year's time.   "
133171|NCT01541852|"     The main purpose of this study is to determine the effect of Losmapimod on blood vessels in     patients with Chronic Obstructive Pulmonary Disease (COPD). Although COPD is a lung disease,     it is also associated with an increased risk of cardiovascular disease (e.g. heart attacks     and stroke). The investigators believe that this is a result of inflammation within the body,     which damages the lining (endothelium) and walls of blood vessels. These changes can promote     the development of fatty deposits within the walls of arteries (atherosclerosis) which can     rupture and block arteries causing damage.   "
133172|NCT01541839|"     The primary objective of this study is to determine if there is a time savings in the     operating room by using a septal stapler instead of suture in closure of primary septoplasty.      The secondary objectives are to determine the subjective outcome of patients undergoing     closure with the septal stapler instead of suture via questionnaire, and to determine if     there is a difference in postoperative complications between groups.   "
133173|NCT01541826|"     The purpose of this project is to determine whether chokeberry polyphenols mitigate     cardiovascular disease risk in former smokers.   "
133174|NCT01541813|"     Chronic iron overload is responsible for morbidity and mortality. There are many genetic and     acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone     for iron. The study explores this specific cause, and aim to characterize this iron overload     in term of clinical, biological, genetic and functional specificities.   "
133300|NCT01540162|"     EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in     Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers     including those on tube feeding tube, diarrhea in children, prophylactics of pathological     colonization in newborns including premature newborns, and improvement of immunity in     newborns (mature and premature).      The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for     immunity improvement in preterm newborn infants   "
133175|NCT01541800|"     MicroRNAs are small molecules which have recently been discovered in cells. They are known to     be responsible for the normal development of cells and when they are disrupted can contribute     to the development of cancer. Many previous studies have been done evaluating the expression     of microRNAs in normal tissues as well as a wide variety of cancers.      Recently, microRNAs from tumor cells have been detected circulating in the blood of patients     with cancer. This presents a novel opportunity to use microRNAs in the blood as an early     predictor of cancer as well as a marker of response to therapy. No previous studies have been     performed evaluating microRNAs in the blood or cerebrospinal fluid of patients with childhood     cancers. We propose a feasibility study to evaluate the presence of microRNAs in the blood     and cerebrospinal fluid of patients with central nervous system tumors, leukemia and lymphoma     who are currently on chemotherapy and undergoing blood draws, lumbar punctures and/or     reservoir taps for routine clinical care. If we're able to identify circulating microRNAs in     this population of pediatric patients, we will build upon this data in proposing a future     study.   "
133176|NCT01541774|"     The purpose of this study is to evaluate the procedural safety and effectiveness of the     Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic     lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is     intended for use in atherectomy of the peripheral vasculature. The intended peripheral     vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system     is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of     this study will be used to support a 510(k) submission to the Food and Drug Administration.   "
133177|NCT01541761|"     The proposed study is a randomized controlled trial to test the effectiveness of a primary     care, family-centered child obesity prevention program beginning in pregnancy and continuing     throughout the first three years of life compared to routine standard of care. The study aims     to reduce the prevalence of obesity at age three, improve child diet composition and healthy     lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center     serving primarily low-income immigrant Latino families. The intervention Starting Early     will consist of three components. 1) Family Groups: interactive groups coordinated with the     child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2)     Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated     into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum     from the family groups.      Hypothesis: Compared to controls, the intervention group will show reduced obesity and     improved parent feeding knowledge and increased healthy feeding attitudes, styles and     practices   "
133178|NCT01541748|"     This study is a prospective, single arm, multi-center, post-market study to evaluate the     efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and     posterior) pelvic organ prolapse repair.   "
133179|NCT01541735|"     The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in     drug-naïve patients with type 2 diabetes.   "
133180|NCT01541722|"     The primary purpose of the proposed study is to characterize the oxidative stress and     inflammatory cytokine status in UCD during baseline and decompensated states.   "
133181|NCT01541709|"     KIT exon 9 mutants had poorer survival compared with KIT exon 11 mutants when they were     treated with the same dose of imatinib, 400 mg per day, and that patients with KIT exon 9     mutation had better progression-free survival with imatinib treatment at an escalated dose,     800 mg per day, than with imatinib treatment at a dose of 400 mg per day.10,11 Based on the     results, imatinib 800 mg per day is now considered the standard dose for the treatment of     patients with metastatic or unresectable GIST showing KIT exon 9 mutation in Western     countries.   "
133182|NCT01541696|"     The broad objective is to improve zinc status in older infants and young children who are at     risk of zinc deficiency because of combination of inadequate dietary zinc intake and high     rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the     proposed study will measure the amount of zinc absorbed from a test meal of typical     unfortified complementary foods consumed by Pakistani infants, or the same complementary     foods fortified by the addition of the Zn-containing Sprinkle.   "
133230|NCT01541072|"     The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution     after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell     malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral     stem cell transplantation.   "
133183|NCT01541683|"     The investigators aim is to study the efficacy of mentholyptus drops in improving the     palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study     is a randomized controlled trial which will include patients undergoing elective colonoscopy     at the American University of Beirut Medical Center. Patients will be randomized into one of     two study arms using a computer generated randomization list. Patients assigned to the     intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while     drinking the PEG solution unlike the control arm patients who will only receive the PEG     solution. All patients will then be evaluated for the tolerability of the preparation while     taking into account the palatability of the solution as main outcome and the remaining volume     of the PEG solution and side effects as secondary outcomes.   "
133184|NCT01541670|"     The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in     subjects with lupus nephritis.   "
133185|NCT01541657|"     The purpose of this study is to determine the effect of 3 types of sensory-targeted     rehabilitation interventions on subjective and objective measures of function for those with     chronic ankle instability. The investigators hypothesize that subjective and objective     measures of function including self-reported disability, balance, and range of motion will     improve after 2-weeks of sensory-targeted interventions.   "
133186|NCT01541644|"     Patients are asked to be in this study if they have multiple myeloma and are having tingling,     numbness and pain from taking bortezomib (velcade®). Patients who have been diagnosed with     multiple myeloma often take bortezomib (velcade®).      This research is being done to find out if acupuncture can reduce the nerve pain, tingling,     and/or numbness patients experience due to bortezomib (velcade®).      Acupuncture is a medical technique of inserting very thin needles into the energy points on     the body with the aim to restore health and well-being. It has been used widely to treat     pain, such as lower back pain and nerve pain. In this study we will see if acupuncture can be     used to ease nerve pain and tingling, numbness that is caused by bortezomib.   "
133301|NCT01540149|"     The purpose of the registry is to assess workload of a Home Monitoring based follow up for     Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy     defibrillators (CRTD) patients.   "
133187|NCT01541631|"     In this study, it is hypothesized that helminth infections modulate immune responses against     HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and     increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of     helminth infections on progression of HIV-1 infection is dependent on helminth infection     intensity, host background immunity, nutritional status, demographic factors and     socio-economic status. Also, treatment of helminth infections using praziquantel and     albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads,     improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction     of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is     associated with poor anthelminthic treatment outcome as compared to non-HIV infected     individuals   "
133188|NCT01541618|"     The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients     before and after beginning Natalizumab.   "
133189|NCT01541605|"     This study aims at evaluating the efficacy and safety of methylphenidate in the initial     treatment of acute mania in patients with bipolar affective disorders.   "
133190|NCT01541592|"     It has been shown that intravenous fatty acids given to normal volunteers in the form of     heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is     not known if this same phenomenon can be demonstrated with oral fat. The investigators are     specifically interested in whether or not there are differences in the induction of insulin     resistance between the 3 main classes of fatty acids (saturated, monounsaturated and     polyunsaturated).      The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of     which frequently accompany insulin resistance.   "
133191|NCT01541579|"     The current multicentre phase III study is proposed to confirm in an add-on therapy design     compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from     healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease     over a 24-week period and an extended follow-up period up to 104 weeks.   "
133192|NCT01541566|"     The purpose of this study is to assess whether, in patients at high cardiovascular risk     (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most     effective when based on home blood pressure telemonitoring and on the feedback to the patient     by the doctor between visits, or when based only on blood pressure determination during     quarterly office visits.   "
133193|NCT01541553|"     The purpose of this trial is to compare the rate of complete clearance of actinic keratosis     (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy     alone.   "
133194|NCT01541540|"     This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects     will continue with their prescribed medications. Our main objective is to assess whether     preventive e-counseling (provided through a website of the Heart and Stroke Foundation)     improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will     also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and     adherence to prescribed medications. Finally, we will quantify the amount of e-counseling     support that is required during REACH to evoke a significant reduction in blood pressure. It     is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and     lifestyle behaviours at the 12-month assessment. The findings of this trial will provide     information that is critical to our understanding of how internet-based programs can help to     improve blood pressure and to reduce the risk for cardiovascular disease.   "
133231|NCT01541059|"     The main objective of this study is to demonstrate the superiority of local analgesia with     ropivacaine versus placebo on postoperative pain during the first 24 hours following     bilateral surgery of all four third molars under general anesthesia.   "
133246|NCT01540864|"     The purpose of this study is to compare the safety and effect of HPP404 versus placebo on     body weight in overweight or obese subjects.   "
133765|NCT01534039|"     A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or     urostomy.      Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin     protection, wear-time, ease of use, ease of teaching, and comfort.   "
133195|NCT01541527|"     Antibodies (Abs) directed against factorVIII (FVIII) remain the main iatrogenic complication     in haemophilia A (HA) patients. Anti-FVIII Abs inhibiting pro-coagulant properties of the     molecule are named inhibitors whereas Abs directed towards non-functional epitopes are named     non-neutralizing antibodies (NNA). These NNA are poorly studied and their prevalence is     ill-defined.      In a recent retrospective study the investigators evaluated, in a cohort of 210 patients     without inhibitor, the NNA prevalence and the NNA epitope specificity against the heavy chain     (HC)or the light chain(LC). For the first time, the investigators used two x-MAP based     assays: the first to determine the specificity of anti-FVIII Abs against the HC or the LC,     the second to display Abs directed towards the B domain. NNA were found in 38 out of 210     patients (18).      Among this NNA positive population, 74% and 13% of patients had anti-FVIII Abs against both     chains. The proportion of NNA directed towards the B domain was 18%.      Considering an approximate inhibitor prevalence of 30% and a NNA prevalence of 19% in severe     HA patients, approximately 50% of severe HA patients develop an immune response against     infused FVIII. Due to their unclear relevance, the NNA detection does not yet belong to the     routine clinical practice.      However, in 2006, Dimichele advancedf a hypothesis concerning the influence of NNA on the     variations in the kinectics of FVIII observed in certain patients.      The mechanism explaining the role of these NNA in the FVIII in the FVIII kinectics has not     still been demonstrated.      The investigators propose to perform a multicentre prospective study with the aim to confirm,     in severe, moderate and mild HA treated patietns, the NNA prevalence observed in our     retrospective study, to study the evolution over time of the epitopemapping of these NNA and     to explore the correlation between these NNA and clinical/biological parameters.   "
133196|NCT01541514|"     The overall purpose to the study is to prospectively study how often patients with and     without acute lung injury (ALI) have patient-ventilator asynchrony demonstrated as stacked     breaths. The investigators seek to describe the quantity of stacked breaths by continuously     recording flow, volume, and pressure waveforms routinely displayed on the vent. The     investigators also seek to describe how primary ICU teams manage asynchrony documenting     interventions of sedation or vent manipulation and what modality is most successful.   "
133197|NCT01541501|"     Study wants to compare central corneal thickness (CCT) obtained through 3 different     no-contact instruments and to compare them with contact ultrasound pachymetry, actually the     gold standard technique.   "
133198|NCT01541488|"     Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses     of BI 1021958 tablets in healthy male volunteers (first-in-human trial)   "
133199|NCT01541475|"     The current study is being conducted in patients with major depression. The study aims to 1)     investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and     bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue,     hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes     using magnetic resonance imaging (MRI), 3) and examine a relationship between the     improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.   "
133302|NCT01540136|"     This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT     chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.   "
133401|NCT01538823|"     The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis     of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective,     screening techniques.   "
133200|NCT01541462|"     Patients requiring the use of artificial ventilation (also called mechanical ventilation) for     more than 21 days account for more than 37% of all ICU costs. As such, these patients are now     transferred to centers that specialize in weaning patients from the respirator; these units     are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC     facilities, research on the fastest method for disconnecting the patient from the respirator     is lacking. In addition, little information is available regarding the long-term survival and     quality of life after a prolonged course of artificial ventilation. The purpose of this study     is to determine the fastest method for disconnecting the patient from the respirator at a     LTAC facility and its effect on long-term survival and quality of life.   "
133201|NCT01541449|"     The investigators think that there is a connection between the use of plaquenil and the     prevention of Age related macular degeneration (AMD). The investigators believe that the use     of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization     (CNV) growth.   "
133202|NCT01541436|"     This research is being done because pain is a significant problem for patients with a variety     of medical problems and following surgery or traumatic injury. Currently available pain     medications may not relieve all types of pain or may relieve pain only at doses that produce     side effects and potential complications.      Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several     unanswered questions about how it works. This research trial will help determine how RIPC may     activate the bodies natural pain control system. The goals of this study are to see if RIPC     has any effect 1) on a small area of skin that will be expose to a small amount of UV- B     radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to     skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the     active ingredient in hot chili peppers) on skin.      Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood     pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then     deflated and blood flow resumes. The process is repeated up to three times. This procedure     causes the body to increase its natural pain relief system that may help to decrease the     amount of postsurgical pain.   "
133203|NCT01541423|"     This observational (non-interventional) study is being conducted to characterize the safety     and use of CINRYZE in routine clinical practice when administered for (1) routine prevention     of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3)     treatment of angioedema attacks.   "
133204|NCT01541410|"     The purpose of this feasibility study is to investigate the clinical performance of the     Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the     thoracic aorta.   "
133205|NCT01541397|"     Prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy to     those not on therapy. The investigators hypothesize that after one year of KUVAN™ therapy,     there will be an improvement in their bone mineral density.   "
133232|NCT01541046|"     Infantile colic is a common medical condition which remains a frustrating problem for parents     and health care providers with no clear treatment guidelines. To fill the void in existing     literature, we present a protocol to examine whether probiotics are effective in decreasing     infantile colic symptoms when compared to placebo treatment.      We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce     symptoms of infantile colic in breastfed infants in comparison to placebo.      An interim analysis will be conducted after 50 infants randomized to monitor both safety and     efficacy.   "
133206|NCT01541384|"     Novel wireless technology has created inexpensive tools that allow both accurate monitoring     of adherence to pills as well as real-time interventions such as automated reminders in the     event of a missed dose. In this study, the investigators will use Vitality GlowCaps, an     electronic pill bottle. These pill bottles provide an unbiased assessment of pill bottle     opening and a valid approach to verifying self-administered pill taking, reflecting not only     daily use but also patterns of drug use and timing. At the prescribed times, bottle will     electronically transmit whether a subject opened the pill cap to take the immunosuppressant     medication via a built-in transmitter to the central server. The investigators will randomize     participants to usual care, customized reminders, and customized reminders paired with     provider notification in the event of low adherence.      The investigators' aim: To improve immunosuppression (IS) medication adherence in kidney     transplant recipients.      The investigators' hypotheses: a) Automated reminders will improve adherence to     immunosuppression compared to usual care, and b) Automated reminders, paired with provider     notification about patients with poor adherence, will improve adherence to immunosuppression     compared to usual care.   "
133207|NCT01541371|"     The purpose of this study is to evaluate the effectiveness of paliperidone extended-release     (ER; designed to slowly release a drug in the body over an extended period of time) tablets     in participants with schizophrenia (psychiatric disorder with symptoms of emotional     instability, detachment from reality, often with delusions [a false belief held in the face     of strong differing evidence, especially as a symptom of psychiatric disorder] and     hallucinations [imagining things], and withdrawal into the self) who were not satisfied with     other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute     psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine,     quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone     ER tablets will also be assessed.   "
133208|NCT01541358|"     This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography     (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic     procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone     cancer   "
133209|NCT01541345|"     Since there are no clinical studies available comparing the gold standard (autogenous bone     graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded     with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the     present exploratory study has been designed.      The aim of the present study is therefore to test whether or not the application of a     xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and     histologically similar outcomes as the gold standard (autogenous bone block) for the     regeneration of chronic ridge defects.      The investigators expect that there is no difference in bone quantity and quality between the     two methods and that the use of the test treatment will be more user and patient friendly     according to the patient perception/acceptance since no second surgical site will be     necessary as well as cause less complications.   "
133314|NCT01539967|"     Obesity is a worldwide health problematic whose incidence is increasing especially in     developed countries. The surgical management of this illness consists in different techniques     such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The     causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the     residual gastric volume.      The aim of the present study was to determine whether the residual gastric volume is involved     in Laparoscopic Sleeve Gastrectomy's failure.   "
133210|NCT01541332|"     The purpose of this clinical research study is to evaluate the safety and effectiveness (good     and bad effects) of a combination of three different drugs, pomalidomide, pegylated liposomal     doxorubicin, and dexamethasone when used to treat relapsed (the disease came back) or     refractory (the disease did not respond to past treatment) multiple myeloma. Different     dosages (amount of study drug) of pomalidomide are first being tested to determine if there     are any side effects or risks associated with combining this study drug with the other two     listed. Once the optimal dose is decided on, the study will change its focus to determining     the effectiveness of the study drug in this combination.   "
133211|NCT01541319|"     A large multicenter randomized controlled trial of approximately 1700 critically ill     patients' status post complex cardiac surgery with sternotomy, called the Red Cell Storage     Duration Study (RECESS), is currently ongoing. In the RECESS trial, study groups are     randomized to either RBCs of less than or equal to 10 days storage time or to greater than or     equal to 21 days. The primary outcome of RECESS is a change in multiple organ dysfunction     score. Secondary outcomes in RECESS include all cause 28-day mortality, mechanical     ventilation free days, and other clinical outcomes. The RECESS study presents a unique     opportunity to investigate mechanisms associated with RBC storage duration in the context of     clinical outcomes for well-characterized surgical study groups. The ancillary study described     here is called the Mechanism and Repository Study (MARS) for RECESS.      The MARS study will analyze the most commonly reported and hypothesized mechanisms considered     to be associated with the RBC storage lesion and adverse outcomes in critically ill patients.     Laboratories with expertise in RBC function, nitric oxide mechanisms, the coagulation     cascade, microparticle analysis and immunology will each examine hypotheses addressing     mechanisms potentially able to relate storage time to clinical outcomes in RBC transfusion     recipients. At the conclusion of the study, the results will provide a much better     understanding of how RBC storage age affects recipient RBC function, coagulation parameters,     microparticle load and immune modulation. Perhaps most importantly, this study will also     develop a large sample repository for future analysis.   "
133226|NCT01541124|"     Background and Objectives:      The drugs used as recommended by the WHO does not promote pain relief for all patients with     cancer pain. The objective of this study was to evaluate the use of morphine as the first     drug for the treatment of moderate cancer pain by visual analogue scale in patients with     advanced disease and / or metastases, as an alternative to the recommendations of the WHO     analgesic ladder advocated. Methods: The patients without opioid therapy with more than 18     years, were randomly divided into two groups. G1 patients received medication according to     the analgesic ladder, starting treatment with non-opioid in the first step, the second weak     opioid and opioid potent in the third, and G2 received morphine as first analgesic. There was     evaluated the efficacy and tolerability of initial use of morphine every 2 weeks for 3     months. Results: The study was performed in 63 patients. The groups had similar demographics.   "
133212|NCT01541306|"     Achondroplasia and hypochondroplasia are the most common forms of dwarfism. Recent studies     have shown that a small hormone called C-type natriuretic peptide (CNP) is an important     regulator of linear growth. The investigators believe that genetic abnormality that causes     achondroplasia and hypochondroplasia also disrupts CNP signaling, which may contribute to the     growth problem. The investigators propose to look at levels of this and other closely related     hormones in children and adults with achondroplasia or hypochondroplasia to see if they are     different from levels in healthy people. The investigators hypothesis is that CNP levels are     elevated in children with achondroplasia or hypochondroplasia, compared the healthy     population. Another hypothesis is that CNP levels are not elevated in adults with     achondroplasia or hypochondroplasia, since adults have no growth-plate cartilage. By studying     the potential role of the CNP system in achondroplasia and hypochondroplasia, not only will     the investigators provide further insight into the pathophysiology of these common syndromes,     the investigators will also provide greater insight into the regulation of normal linear     growth.   "
133213|NCT01541293|"     This is a study to investigate whether instilling a small amount of liquid lidocaine into the     uterus will decrease pain felt by women during laminaria insertions done for cervical     dilation prior to second trimester abortion.      The investigators hypothesize that women who receive intrauterine lidocaine in addition to a     paracervical block will experience less pain than women who receive only a paracervical     block.   "
133214|NCT01541280|"     Patients included in the study with high risk acute myeloid leukemia or myelodysplastic     syndrome as defined will receive an allogeneic transplantation conditioned by either     myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive     a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with     donor lymphocyte infusion.   "
133215|NCT01541267|"     The main purpose of the study is to compare the effects of three different types of RAAS     blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.   "
133216|NCT01541254|"     The purpose of this study is to evaluate the safety and probable benefit of the Low-profile     Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when     used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with     bare platinum embolization coils.   "
133217|NCT01541241|"     THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients     with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery     resistance index and pulsatility index) to prove the relationship between these changes and     bleeding in these patient .   "
133218|NCT01541228|"     Aim of the study: To evaluate clinical effectiveness of two different light doses when     treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.   "
133219|NCT01541215|"     This trial is conducted globally. The aim of this trial is to assess the efficacy and safety     of liraglutide in the paediatric population in order to potentially address the unmet need     for treatment of children and adolescents with type 2 diabetes.   "
133220|NCT01541202|"     The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of     heart failure.   "
133221|NCT01541189|"     To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.   "
133222|NCT01541176|"     The main objective of this study is to demonstrate that the absence of post-transplantation     corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical     reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy     that includes standard oral corticosteroids.The secondary objectives of the study consist to     compare on various parameters (fibrosis progression, renal function, dialysis, ratio of     proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical     and biological tolerance) therapy with no corticosteroids post-transplantation in comparison     to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary     objectives of the study consist also to compare the two techniques for assessing fibrosis by     numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical     pathologists).   "
144633|NCT01391260|"     The purpose of this study is to access the effect and safety of radiotherapy combined whth     Iressa for patients with locally advanced non-small cell lung cancer with harboring active     EGFR mutations.   "
133223|NCT01541163|"     Although cardio-embolic etiology of ischemic stroke (IS) is largely respected, there is still     no clear recommendation for routine complex cardiological examination in all IS patients.     Using complex cardiological examination the investigators expect:        1. more accurate detection of patients with concomitant heart disease (cardiac rhythm          disorder, valve disorders, acute coronary syndrome, cardiac thrombus and myxoma, atrial          and ventricle septum defects)        2. higher number of etiologically determinated IS, which is crucial for accurate secondary          prevention.   "
133224|NCT01541150|"     Pedophilic behaviors represent a public health problem with serious consequences. The     investigators hypothesize a disruption in the decision-making strategies among sex offenders     pedophiles. Highlight this type of abnormality would offer a specific treatment of a possible     neuropsychological deficit (with cognitive remediation for instance) and perhaps avoid     recurrences of this type of behavior.   "
133225|NCT01541137|"     The investigators investigated whether a strictly controlled pain management with patients     participating in a clinical study can attenuate persistence of post-thoracotomy pain. The     investigators also wanted to find out whether NSAID + intravenous patient-controlled     analgesia with morphine is an efficacious alternative to thoracic epidural analgesia.   "
133227|NCT01541111|"     This study is an evaluation of the analgesic effect of magnesium associated with morphine in     patients with cancer pain.   "
133228|NCT01541098|"     This is a multi center, phase 2 randomized controlled study to determine the effect of     lyophilized plasma in patients on warfarin therapy.   "
133229|NCT01541085|"     The purpose of this study is to study the kinetics (study of the rate of change) of immune     recovery quality and function in stored plasma blood samples of treatment-naive (not     previously treated with antiretroviral drugs) patients with advanced human immunodeficiency     virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active     antiretroviral therapy (HAART) regimen.   "
133234|NCT01541020|"     Proprioceptive weighting changes may explain differences in postural control performance. In     addition, the respiratory movement has a disturbing effect on postural balance. Postural     balance seems to be impaired in individuals with respiratory disorders. Besides the essential     role of respiration, the diaphragm may also play an important role in the control of the     trunk and postural balance. Deficits in proprioception are found in a subgroup of patients     with low back pain. In addition, disorders of respiration have been identified as strongly     related to low back pain.      The aim of the study is to clarify whether loading of the inspiratory muscles has a negative     effect upon proprioceptive postural control in healthy individuals and individuals with     recurrent low back pain.   "
133235|NCT01541007|"     Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men     with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic     Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4     patients treated with Cabazitaxel in this study required dose reductions or dose delays or     stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see     if we can improve tolerability so that patients will receive a higher percentage of the     treatment as planned.   "
133236|NCT01540994|"     The purpose of this study is to evaluate a short course (five radiation treatments) of very     focused (stereotactic) external beam radiation therapy for the treatment of early stage     prostate cancer.   "
133237|NCT01540981|"     The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction     with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury     (DTI) progression to advanced stage pressure ulcers.   "
133238|NCT01540968|"     The purpose of this study is to investigate the effect of a combined treatment of nutritional     therapy and physical exercise in palliative cancer out-patients. The investigators     hypothesize that this combined intervention consisting of an increased energy- and protein     intake and physical exercise level improves quality of life (QoL), functional and clinical     status.   "
144683|NCT01390610|"     The purpose of this study is to use data from the Continuous Glucose Monitoring (CGM) device     and your Self-Monitored Blood Glucose (SMBG) levels to determine the best times to test blood     glucose levels using SMBG.   "
133239|NCT01540955|"     There are over 2 million breast cancer survivors in the US today. Along with extended     survival, many women experience short and long-term after effects of treatment, which may     decrease their quality of life and contribute to other health problems. Cognitive     complaints---difficulties with memory, concentration, and planning—are commonly reported     after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a     5 week group-based cognitive rehabilitation intervention on improving cognitive complaints     and test performance, in comparison to women who will receive the same intervention at a     later time (wait-list control). Women will also have an EEG test performed before and after     the intervention program to see if improvements in cognitive complaints and performance can     be documented by examining the EEG.   "
133240|NCT01540942|"     The study was aimed to determine whether perioperative nutrition treat and(or)the     perioperative disease activity were associated with postoperative recurrence and     complications after bowel resection for Crohn's disease.   "
133241|NCT01540929|"     This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s     (SF600s) generated during screening of service members for possible immunization with the     ACAM2000® smallpox vaccine.      Primary Objective:        -  To evaluate the accuracy of the DoD smallpox vaccination screening process in military          personnel.      Secondary Objective:        -  To describe the number of subjects who are excluded from vaccination, stratified by the          pre-defined categories for exclusion (separately for the Screened and Evaluable          Populations).   "
133242|NCT01540916|"     Alterations of acid-base equilibrium are very common in critically ill patients. Thus,     understanding their pathophysiology and the possible compensatory mechanisms acting in     different organs may play an important role in better set the consequent clinical treatment.     The lung and the kidney are the two principal actors of such regulations. Although the     respiratory response to acid-base alterations is well understood, less information are     available for what the renal system is concerned. Such lack of information is partially due     to: 1) the historical consideration of the kidney as a slow organ, in response to     variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess     renal response.      Our group has recently developed a monitoring system aimed at analyzing, in a     quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of     urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium).      The investigators hypothesize that the renal system reacts to large as well as to minimal     variations of the acid-base equilibrium (especially induced by a variation in the respiratory     function) in a very fast way, modifying the urinary concentration (and therefore the urinary     excretion) of ammonium and some electrolytes (especially chloride).   "
133243|NCT01540903|"     The proposed trial will evaluate whether relatively non immune populations in endemic     countries can be effectively infected with aseptic, purified, cryopreserved sporozoites     (PfSPZ Challenge) given intradermally.   "
133244|NCT01540890|"     Main of the study is to assess the influence of high-dose opioids on the sleep architecture     and patterns of breathing using non-invasive polysomnographic measurements before and after     opioid withdrawal in patient who undergo opioid withdrawal independently from the present     study. These data will be compared to polysomnographic data of patients under opioid     treatment who do not undergo opioid withdrawal as well as to patients without opioid     treatment.   "
133245|NCT01540877|"     Main of the present study was to develop a model of concomitant C-fibre block and     sensitization eliciting spontaneous pain as well applying topical capsaicin and local     anesthetics (LA) to examine the sensory alterations after combined C-fiber block and     sensitization in both different application orders (sensitization of blocked C-fibers and     block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect     stronger sensory changes during the combined substance application than during the     monoapplication. We expect also contralateral sensory alterations mirroring the changes on     the intervention site after the combined capsaicin and LA application, being stronger than     after sensitization alone absent after C-fiber block alone.   "
133247|NCT01540851|"     The objectives of this research are to:      Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing     primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will     compare a Care Navigator post-discharge intervention versus Usual Care post discharge     management of patients undergoing TKA. The intervention will focus on the challenging process     of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and     from inpatient rehabilitation to home.      The principal goals of the trial are:        1. To establish whether Care Navigator intervention improves functional outcomes as          compared with the Usual Care treatment six months after TKA surgery.        2. To establish whether Care Navigator intervention is cost effective six months after          TKA surgery.      The investigators hypothesize that:        1. Incorporating the Care Navigator role into the Usual Care treatment will increase TKA          patients' rate of adherence to the rehabilitation protocol and improve functional          outcomes.        2. Addition of a Care Navigator is cost-effective.   "
133248|NCT01540838|"     The main purpose of this trial is to test if mortality of childhood bacterial meningitis can     be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional     bolus administration four times daily (qid), combined with high-dose paracetamol orally, when     both treatments are executed for the first 4 days. The series will be collected at Hospital     Pediátrico David Bernardino, Luanda, Angola.      The recruitment of patients begins, the conditions permitting, in early 2012. The criteria     for patient participation is a child at the age of 2 months to 15 years who presents with the     symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is     performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.   "
133249|NCT01540825|"     The primary objective of the current study is to investigate the safety and tolerability of     BI 113608 in healthy male volunteers following oral administration of single rising doses.      A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single     dosing.   "
133402|NCT01538810|"     The purpose of this study is to assemble a collection of urine and blood samples for the     development and validation of biomarkers potentially useful in correlating or improving the     diagnostic utility of abdominal imaging.   "
133250|NCT01540812|"     Trial protocol intended the optimization of induction treatment with:        1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.        2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of          high doses of anthracyclines has not brought higher response rates or longer duration        3. Replacing the poor cytological response at day 14 by the level of ER at the end of          induction as a criterion to decide the further treatment (consolidation or second          induction), so as to have only one criterion (the ER) throughout the study to decision          making.      For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity     during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a     more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2)     in patients with ALL-T, since there is recent evidence of a higher response rate with this     strategy.      Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate     level of ER after two cycles of induction or in those patients who required two courses of     induction and have obtained proper ER after the second.      Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards,     to avoid bias in making treatment decisions   "
133251|NCT01540799|"     The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine     ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache     symptoms and migraine frequency in high disability migraineurs.   "
133252|NCT01540786|"     This study aims to identify differences in bladder contractions during the storage phase (non     voiding activities) between OAB subjects and healthy subjects, using high resolution     urodynamics.      The study is divided into two parts:        -  PART 1: Consists of 5 females with overactive bladder        -  PART 2: Consists of 25 females with overactive bladder and 15 healthy females      Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects     will be reviewed and analysed by a group of experts before starting the second part (part 2)     of the study.   "
133253|NCT01540773|"     The purpose of the study is to confirm the results of a prior study that demonstrated pills     containing two amino acids which are in foods increased growth hormone and insulin-like     growth factor-1.   "
133254|NCT01540760|"     This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose     study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy     volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15     and 29.   "
133255|NCT01540747|"     To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF)     outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).   "
133256|NCT01540734|"     A single dose pharmacokinetic study investigating two paracetamol formulations   "
133257|NCT01540721|"     This study will evaluate the pharmacokinetic profiles of experimental formulations of     paracetamol.   "
133270|NCT01540552|"     RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung     cancer may help doctors learn more about the disease and find better methods of treatment.      PURPOSE: This trial studies the natural history of lung nodules using CT scans from     participants at high-risk for lung cancer.   "
133271|NCT01540539|"     The purpose of this study is to study the safety and tolerability of intravenous (IV) and     subcutaneous (SC) administration of REGN1154 in normal healthy subjects.   "
133283|NCT01540383|"     The purpose of this study is to examine whether 3 weeks of intensive language therapy     provided in clinical in- and outpatient settings is effective in improving everyday     communication in postacute/chronic post-stroke aphasia, as measured by performance on the     Amsterdam Nijmegen Everyday Language Test (ANELT).   "
133284|NCT01540370|"     This study will evaluate assessments from the Goniometric Lens compared with those from     anterior segment imaging in patients with open-angle glaucoma (OAG) and/or ocular     hypertension (OHT).   "
133285|NCT01540357|"     In the present randomized waiting-list-controlled study the investigators examined a specific     manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.   "
133258|NCT01540708|"     The purpose of this study is to optimise the device and/or formulation of the Fluticasone     propionate (FP)/salmeterol (SALM) unit dose powder inhaler (Rotahaler) to achieve drug     delivery characteristics comparable to the Fluticasone propionate /salmeterol DISKUS inhaler.     The indication is asthma and chronic obstructive pulmonary disease. The study is an     open-label, randomised, cross-over, single centre study in healthy volunteers and will be     conducted in a maximum of 3 parts, A, B and C. The design is adaptive and pharmacokinetic     (PK) data analysis follows each part to enable a decision on whether progression to the     subsequent parts is required.      Part A of the study will test an alternative version of the Rotahaler with a low airflow     resistance. The study will then test one or more of the following options depending on the     outcome of part A. If progressed, part B will test modified Rotacap formulations including:     (1) modified blend formulation, (2) reduced capsule fill weights, (3) different capsule     types. Part B will also test other versions of the Rotahaler with intermediate airflow     resistance. Part C will test the lower strength FP/salmeterol (100/50 mcg or lower) and/or a     new unit dose DPI device (BUDI).      A total of 36 subjects will be enrolled in each part to ensure 32 complete. In each     cross-over arm, subjects will be administered 7 doses (3.5 days bid) with PK sampling     following administration of the 7th dose. A three-day minimum wash-out period will separate     each cross-over arm.   "
133259|NCT01540695|"     This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to     determine whether:        1. The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE)          H&E sections alters the histology in skin tumor specimens.        2. Which specific histologic parameters are altered between previously cryofixed versus          routine FFPE sections. Histologic observations will be recorded by two          dermatopathologists and two Mohs surgeons and statistically analyzed.   "
133260|NCT01540682|"     This study will evaluate the initial safety and effectiveness of an investigational drug,     MLN8237, added to routine radiation therapy and cetuximab in patients with head and neck     cancer. This study will also determine the highest dose of MLN8237 that can be given together     with cetuximab and radiation therapy without causing severe side effects.   "
133261|NCT01540669|"     The aim of the study is to test the effect of polydextrose on whole gut transit time and     gastrointestinal symptoms in a dose-responsive manner.   "
133262|NCT01540656|"     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in     pressure was observed in the external urethral sphincter along with an increase in bladder     capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve     Stimulation (TMNS) in women could induce pressure increment of the external urethral     sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33     women suffering from urinary stress incontinence were able to contract their pelvic floor     muscles and had become free of symptoms. Another pilot study has shown promising effect on     the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after a     radical prostatectomy have shown promising results. A randomized investigation of TMNS     applied in the immediate period after a radical prostatectomy to investigate effects on both     continence and erectile function is on going.      The present study aims to treat urinary incontinence in men who are still incontinent more     than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6     weeks and the results of the treatment is then evaluated. The participants will be randomized     to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts after 6 weeks     when group 1 is done. The groups are compared at baseline, at 6 weeks and at 12 weeks.      The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks     with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis     of questionnaires, micturition diaries and diaper tests.      If the investigators are able to demonstrate a significant reduction in the incontinence     symptoms in the subjects the investigators asses that vibration can be a way of     reestablishing normal continence in men after a radical prostatectomy.   "
133264|NCT01540630|"     This is a double-blind, randomized withdrawal study comparing CNV1014802 with placebo in     patients with trigeminal neuralgia who have successfully responded to CNV1014802 in an     initial open-label phase.      Patients will participate in an initial open-label treatment period of 21 days of CNV1014802     150mg three times a day (tid). Responders will be randomized to 28 days of CNV1014802 150mg     tid or placebo.      Following an interim analysis after 10 evaluable patients have completed the open-label     phase, the dose regimen may be increased to 350mg twice a day (bid) for the remainder of the     trial if the responder rate is less than 60%.   "
133265|NCT01540617|"     Low back pain (LBP) is a well known health problem in Western society that is significantly     responsible for socio-economic problems like absenteeism and disability. The lifetime     prevalence of LBP is 60-80% and approximately 85% of this LBP has a non-specific character     whereby the underlying causes and risk factors cannot be demonstrated. While many people     recover within a month, most individuals will have recurrence within a year with more severe     symptoms. This might be due to insufficient knowledge of the underlying mechanisms. Impaired     proprioception, the ability to discern body/limb positions and movements, may cause and     maintain LBP shown by an altered postural control strategy. Specifically, patients with LBP     rely more on proprioceptive signals from the ankles due to less reliable proprioceptive input     of proximal segments. Moreover, they show a decreased variability in postural control and     less postural robustness, while variability is a prerequisite for optimal functioning of     biological systems. However, further clarification of the neural correlates is necessary.     Deficits in proprioception, as found in a subgroup of patient with LBP, are associated with a     decreased ability of the brain to process proprioceptive inputs.      The aim of this project is to clarify the central changes in individuals with recurrent     non-specific low back pain and healthy controls. To evaluate these central changes MRI     techniques (3DTFE, DTI and RS-fMRI) will be used. In addition, the association between     central changes and postural control tasks will be evaluated.   "
133266|NCT01540604|"     This is an investigation of the efficacy and safety of CRD007 in Duchenne Muscular Dystrophy     (DMD), Becker Muscular Dystrophy (BMD) and symptomatic carriers.   "
133267|NCT01540591|"     Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm     injection ( ICSI) failure due to elevated TH1 cytokine response.   "
133268|NCT01540578|"     This clinical trial is studying biomarkers as a diagnostic tool in samples from younger     patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help     improve the treatment of patients with B-cell acute lymphoblastic leukemia   "
133269|NCT01540565|"     This phase II trial studies how well veliparib works in treating patients with epithelial     ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond     to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth.   "
133909|NCT01532102|"     The purpose of this study is to determine the safety, tolerability and efficacy of the     topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human     papillomavirus (HPV).   "
133272|NCT01540526|"     The main purpose of this study is to learn more about the safety of an investigational drug,     axitinib. An investigational drug is a drug that has not been approved by the Food and Drug     Administration (FDA) and is available for research use only. Researchers will also see what     changes happen to the tumors while taking the axitinib and after it is stopped (during the     scheduled breaks), and what changes in the tumor may be responsible for this growth. This     will be done by using a special kind of scan called an 18F-FLT PET/CT. This scan is     considered an investigational type of scan and is not used for clinical care. These scans are     not approved by the FDA, their use in this study is just for research purposes.      In addition, the investigators want to find out how the drug is processed and distributed in     the human body. The investigators will also look at how different types of cancer are     affected by axitinib.   "
133273|NCT01540513|"     The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404     PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and     determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating     tumor dosimetry. The long-term goals of this research are to improve the diagnosis and     treatment of malignant brain tumors by using radioiodinated NM404   "
133274|NCT01540500|"     The purpose of this research study is to evaluate whether administration of a CYP1A2     inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The     safety and tolerability of tasimelteon will also be assessed throughout the study.   "
133275|NCT01540487|"     The aim of the trial is to assess the relative bioavailability of fixed dose combination     tablets of linagliptin and metformin compared to the administration of two single tablets     (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose     combination tablet is expected to significantly enhance patients` compliance with     antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic     patients.   "
133291|NCT01540279|"     Background: Poor wound healing and the development of surgical site infection (SSI) continue     to occur and remain a significant cause of disability among operated patients. In spite of     the substantial advances in our understanding of the epidemiology, pathogenesis and     prevention it remains one of the most common complications in conventional abdominal surgery     with an incidence in the literature between 4% and 17%. As it is known that surgical sutures     potentiate the development of wound infection the search for an ideal suture material,     suitable for all purposes has been pursued by surgeons for decades.      Hypothesis: In line with in-vitro results the investigators hypothesize that the use of     antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after     open abdominal surgery Methods: To prevent microbial colonization of suture material in     operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture     materials with antibacterial activity will be tested against un-coated suture material for     skin closure after open abdominal surgery of 200 patients. The study is planed as a single     center, randomized controlled trial. After ethical approval the patients will be     consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University     Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to     detect and document wound complications. Wound complications will be classified according to     Center for Disease Control and Prevention Standard guidelines. Data will be collected and the     rate of SSI will be analysed in both groups.      Expected value of the proposed project: If the investigators can confirm the proposed     hypothesis in our study this could be a promising and feasible approach to lower SSI after     open abdominal surgery and might be also used in other surgical fields. By lowering the rate     of SSI the investigators might offer a new and cost saving procedure to the surgical     community.   "
133276|NCT01540474|"     Malaria has remained a major concern for the US military. During World War II, malaria was     the leading cause of disease and non-battle injury with 500-700 men infected per day,     resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for     protecting troops against malaria are insecticidal nets, clothing, and antimalarial     treatment. To be effective, these methods must be self-administered and be used consistently,     often unattainable in field or combat situations. The United States Army Medical Research and     Development Command (USAMRMC), through the United States Army Medical Materiel Development     Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively     pursuing the development of an effective vaccine against P. falciparum malaria; development     of such a vaccine is a high priority for the US military and other individuals who travel to     endemic regions, and is equally important to populations residing in those areas.      A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine     will        1. assess the safety and reactogenicity of candidate P. falciparum malaria vaccine          FMP012/GLA-SE           Secondary:        2. measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent          assay (ELISA)        3. assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite          challenge.   "
133277|NCT01540461|"     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability     of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).   "
133278|NCT01540448|"     The aim of this study is to evaluate if the prior knowledge of the individual mesenteric     vascular anatomy of patients represents an advantage in performing laparoscopic colorectal     resections. The investigators want demonstrate that the three-dimensional reconstruction of     colonic vascular anatomy, acquired with a CT angiography, may lead to a more effective and     less extensive dissection and to a fewer intraoperative and postoperative complications.   "
133279|NCT01540435|"     This randomized, controlled, multicenter, non-comparative phase II trial compares an     intensified perioperative treatment of patients with resectable synchronous or metachronous     colorectal liver metastases to primary surgery and adjuvant systemic chemotherapy.   "
133280|NCT01540422|"     The purpose of this study is to demonstrate improved vein graft patency rates at 12 months     for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications     to existing techniques in vein graft handling during harvests. A secondary aim is to develop     a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic     approach.   "
133281|NCT01540409|"     The primary objective of this study is to assess the ongoing efficacy, safety, and     tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne     muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen     study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers     for DMD and the clinical status of participating DMD subjects.   "
133282|NCT01540396|"     This is a pilot feasibility study of 40 pregnant women to test the investigators'     recruitment, enrollment and randomization procedures in preparation to conduct a larger     randomized control trial to compare diagnostic methods for gestational diabetes. The two     methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1     hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and     Coustan criteria).   "
133286|NCT01540344|"     The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of     perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and     bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal     carcinomatosis arising from colorectal cancer.   "
133287|NCT01540331|"     The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term of     IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.   "
133288|NCT01540318|"     The major goal of this project is to conduct a randomized controlled trial studying an     initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal     ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's     objectives are to compare the following variables in those that randomize to abdominal     ultrasound versus those that do not:        1. rate of abdominal CT scanning        2. time to emergency department disposition        3. the rate of missed/delayed diagnosis of intra-abdominal injury        4. the costs.   "
133289|NCT01540305|"     This study aimed at verifying whether sessions of repetitive transcranial magnetic     stimulation over a certain brain area (the supplementary motor area) could be useful in the     relief of Obsessive-Compulsive Disorder symptoms.   "
133290|NCT01540292|"     This project aims to assess safety and efficacy of allogeneic Mesenchymal stem Cell (MSC) in     Crohn's disease refractory or intolerant to conventional therapies. Twenty patients with     active refractory Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) > 220     despite conventional treatment will be included over 4 years in this phase I-II trial. This     will be a pilot open label trial. Patients will be treated with 2 successive injections of     allogeneic MSC at baseline and 4 weeks later. Patients will be followed up at weeks 2, 4, 8     and 12.   "
133292|NCT01540266|"     Assessing whether structuring of discharge information improves the sender's recall capacity   "
133347|NCT01539525|"     The investigators propose to use obstetric-gynecological clinics to conduct a randomized     clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and     Treatment), delivered either by a trained nurse or by computer, to usual care (a control     condition). As part of this trial, the investigators will include outcomes that allow us to     assess the cost effectiveness of these three conditions.   "
133293|NCT01540253|"     This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given     together with docetaxel in treating patients with advanced solid tumor that is locally     advanced, cannot be removed by surgery, or metastatic. PI3K inhibitor BKM120 may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120     together with docetaxel may kill more tumor cells.   "
133294|NCT01540240|"     The primary objective of the study is to compare the tolerance and safety between a low-dose     Zidovudine (AZT) containing regimen (200 mg BID) and a standard dosage (300 mg BID) in HIV     patients initiating a first line antiretroviral therapy. The investigators expect that the     low-dose regimen will show improved tolerability and safety compared to the standard dosage,     with significant reduction in number of patients experiencing a new grade 1 to 4 anaemia or     increasing their anaemia grade during the first 6 months of treatment.      The secondary objectives of the study is to compare the efficacy of the two dosing regimen,     as measured by classical clinical and biological markers: the number of new AIDS defining     illness, the mortality rate, the proportion of patients achieving virological success and the     mean CD4 cell count increase from baseline.   "
133295|NCT01540227|"     Syphilis is a sexually transmitted infection that causes genital sores and rash, but in some     circumstances may result in more severe and unexpected symptoms. These severe symptoms could     include eye infections, meningitis (infection of the membranes covering the brain and spinal     cord), and liver infection. If not properly treated, syphilis can also lead to heart problems     and dementia (a decline in reasoning, memory and other mental abilities) years down the road.     There has been an increase in the number of reported cases of syphilis in North America,     Europe, and Australia over the past decade. The number of new syphilis infections in Canada     has increased roughly 10-fold over the past 10 years.      Since 1943, the antibiotic penicillin has been used to treat syphilis; however, very little     information has been gathered to determine the proper dose of penicillin or appropriate     duration of treatment. Added to this, several studies have shown that the recommended dose of     penicillin fails to cure syphilis in 20-30% of patients. Since the number of people infected     with syphilis is increasing, and since syphilis has the potential to cause serious disease,     the investigators need better information on how to treat syphilis effectively.      This study aims to determine whether the current dose of penicillin recommended to treat     syphilis is sufficient to cure the infection. Specifically the investigators will try to     determine whether the amount of penicillin in your blood 3 and 7 days after receiving     treatment for syphilis is sufficient to cure the infection as demonstrated by a blood test 6     or 12 months from now. This study is a multi-centered trial based in Ottawa but with centers     recruiting both in Montreal and Toronto. A total of 120 participants with syphilis will be     recruited into this study. The treatment you will receive for syphilis in this study does not     differ from that you would receive normally; the investigators are only observing the levels     of penicillin in your blood and relating them with the outcome of treatment.   "
133296|NCT01540214|"     Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are     present in approximately 50% of patients with POP. For many women the accompanying symptoms     of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse     may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with     dissatisfaction with the final results of an operation for POP.      The primary aim of this research project is to investigate the difference in prevalence (i.e.     improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery.     The secondary objectives are to determine changes in bladder function at 6 and 12 months     after surgery and to identify predictive factors for persistence, disappearance or de novo     symptoms of OAB after POP surgery.      Women who present with POP and who will undergo surgical treatment will be evaluated at     baseline before their surgery and will be followed for the duration of one year after     surgery.   "
133297|NCT01540201|"     Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation     (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the     inspiratory time greater than expiratory time, can be applied for adult respiratory distress     syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway     pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with     lung protective strategy.   "
133541|NCT01537003|"     The purpose of this trial is to determine if wounds with elevated protease activity (EPA)     treated with targeted interventions such as protease modulating therapies can improve     clinical and economic outcomes.      Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds   "
133298|NCT01540188|"     Vietnam is currently experiencing two epidemics -- injection drug use and HIV. HIV infection     is rising rapidly, primarily among injecting drug users (IDUs). Most young IDUs keep daily     contact with their family or live in their parent's home. The burden on their families is     substantial, and even greater if the IDU is HIV+. In this study, the investigators conduct an     intervention pilot to develop and evaluate a family intervention to improve outcomes over     time for Vietnamese IDUs and their families. This two-year study is conducted in Phu Tho, a     province located about 80 km from Hanoi, Vietnam's capital.      Two teams with complementary expertise collaborate to implement this study: the UCLA team and     the Vietnamese team from the Vietnam National Institute of Hygiene & Epidemiology (NIHE). The     study has two phases:        -  In Phase 1, the investigators develop the content, format and an implementation plan for          the intervention from a focus group of 10 service providers, administrators and          community leaders, and through in-depth interviews with 40 IDUs (20 HIV+ and 20 HIV-)          recruited from the local drug rehabilitation center (the 06 Center) and from two local          communities (Duu Lau and Gia Cam), as well as in-depth interviews with 20 of the IDUs          family members (FM). Based on the findings, the investigators collaborate on designing a          Vietnamese-specific family intervention for IDUs and their family members.        -  In Phase 2, the investigators pilot the intervention in the local commune health centers          in Viet Tri, Phu Tho. Eighty IDUs (HIV+/HIV-) and 80 of their family members are          recruited from 4 communes and the 06 Center in Viet Tri city, and randomized into a          intervention group and a control group. After the 4-week intervention, 3-month and          6-month follow-ups are conducted to assess the effectiveness of the intervention.          Participants randomized to the control group only complete the assessments (baseline,          3-, and 6-month) at the same time points.   "
133299|NCT01540175|"     Autologous stem cell rescue is an established therapy in high risk neuroblastoma and relapsed     Hodgkin's lymphoma and an experimental therapy in some other solid and brain tumors to     facilitate the use of very intense chemotherapy beyond bone marrow tolerance. It is usually     tolerated with acceptable toxicity and graft failure is practically not existent. But whereas     immune reconstitution in allogeneic hematopoietic stem cell transplantation (HSCT) setting is     widely studied, the investigators have no comprehensive data available in the autologous     setting regarding recovery of the innate and adaptive immune system. However, observations in     patients with autoimmune disease undergoing autologous HSCT suggest not an exact recovery of     the patient's pre-transplant immune system but some re-education during reconstitution of     immune function.      Also, recent developments of cancer-directed immunotherapy with monoclonal antibodies and     immunocytokines rely on activity of the patient's own immune system via complement-mediated     or antibody-dependent cellular cytotoxicity. These novel therapies are given either with or     shortly after conventional chemotherapy. To find the optimal time point for administration of     immunotherapy, it is important to know how and when immune effector cells recover after     conventional myelosuppressive and/or immunosuppressive chemotherapy which are used in     Induction regimens.      Researchers at St. Jude Children's Research Hospital want to study the research participant's     immune profile once prior and at multiple set time points after autologous stem cell infusion     during the recovery process. In a subset of participants the investigators want to study the     recovery of lymphocyte subsets and function after one course of conventional chemotherapy     preceding the high dose chemotherapy and autologous stem cell transplant. That way the     investigators hope to learn about the pace and order of recovery and the functional capacity     of different compartments of the immune system during reconstitution.   "
133428|NCT01538472|"     The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and     rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or     marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the     chances of the cancer coming back.   "
133303|NCT01540123|"     Berry fruits are widely recognised as natural functional food products. They contain several     different phytochemicals which have potential to modulate human health and wellbeing. There     is however some debate regarding the mechanisms driving their health promoting properties.      Despite the wide health promoting properties of fruit extracts reported in the literature,     considerable interest over the past decade has primarily been focused on their roles in     reducing risk factors associated with cancer and heart disease. Consequently, there remains a     paucity of actual scientific information on their role in modulating brain functions, such as     mood, learning and memory, any decrements of which have very negative impacts on the quality     of life.      Fruit phytochemicals from other sources have been shown to mediate both peripheral and     cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with     berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of     oxygen and glucose as well as the removal of waste products. The modulation of cerebral blood     flow via supplementation of berry polyphenols could therefore be a potential way to     positively modulate human cognitive behavior. The link between acute increases in cerebral     blood flow and increased cognition is currently a little weak but it could give a good     platform for long term behavioral and health benefits via increased cerebral/peripheral blood     flow and decreased MAO-B activity.      The aims of the study are therefore to investigate the impact of the berry extract on digital     volume pulse, blood pressure and cerebral blood flow.   "
133304|NCT01540110|"     Primary      The purpose of this study is to evaluate tumour pathological complete response rate after six     cycles of neoadjuvant docetaxel and cyclophosphamide in an Asian population.      Secondary      To assess:        1. Pharmacokinetics (PK) and pharmacogenomics (PG) of docetaxel cyclophosphamide in Asian          patients,        2. Safety and toxicity of docetaxel cyclophosphamide in Asian patients, and        3. To determine efficacy of short course (3 days) filgrastim in primary and secondary          prophylaxis against febrile neutropenia in patients receiving docetaxel and          cyclophosphamide.   "
133305|NCT01540084|"     Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep     sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause     oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can     reduce the dosage of propofol and may result in a lower risk of oversedation. The     investigators prospectively compare the efficacy, recovery time, patient satisfactory, and     side effects between cocktail and conventional sedations in patients undergoing ERCP.   "
133306|NCT01540071|"     This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing     down/stopping/reversing progression of the castration resistant and taxane resistant prostate     cancer.   "
133307|NCT01540058|"     This is a european randomised, phase III, multi-centric study comparing a diagnostic and     therapeutic strategy based on molecular analysis followed by suspected primary cancer     tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown     primary. The purpose of this trial is to determine whether or not a strategy based on     molecular analysis is effective in improving the progression free survival rates of patients     with carcinoma of unknown primary (CUP).   "
133328|NCT01539785|"     The purpose of this study is to determine the role of surgery followed by hyperthermic     intra-peritoneal chemotherapy (HIPEC) versus surgery alone in patients with     platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective     randomized multicenter trial, aimed to investigate the prognostic role of surgery plus HIPEC     versus surgery alone in terms of progression free interval, overall survival, morbidity and     mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28     questionnaires.   "
133542|NCT01536990|"     The purpose of this study was to investigate the reliability, construct validity, and     sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected     by stroke.   "
133308|NCT01540045|"     One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the     combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like     dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight     loss and malnutrition, which leads to a prognostic impact in a lower patient response to     chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects,     impacting treatment discontinuation and therefore, morbidity and survival of patients. The     objective of this study is to describe the threshold of perception and recognition of basic     tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy     and after the second cycle, and analyze the effect in the developement of dysgeusia, as well     as the association between these and the nutritional status and quality of life.   "
133309|NCT01540032|"     The purpose of this study is to determine whether a low salicylate diet will improve the     quality of life of patients with Aspirin Exacerbated Respiratory Disease (AERD).   "
133310|NCT01540019|"     Denutrition, lost of weight and anorexia are present in many oncologic patients at any time     of the disease. Anorexia is the spontaneous loss of appetite and many changes in the     metabolism are made in this case, leading to this syndrome called anorexia-cachexia, that     includes changes in the tumoral response and inflammatory pathways. The guaraná (Paullinia     cupana) is originally from Brazil and Venezuela and has been used culturally for headaches,     muscle pains, depression and others. As it has shown a good response and tolerability for     fatigue, the investigators decide to try guaraná for anorexia. Patients will receive guaraná     as capsules of 50 mg twice daily, for 4 weeks, and will be weighted and respond questionaries     about quality of life.   "
133311|NCT01540006|"     The aim of this prospective trial is the manifestation of guidelines developed for outpatient     cardiac rehabilitation in Austria.      The evaluation of prospective and retrospective data is supposed to give evidence on     morbidity and/or mortality advantages compared to patients not participating in cardiac     rehabilitation programs.      The database created in this context is supposed to pave the way as instrument to document     and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in Austria     as a key for quality management.   "
133312|NCT01539993|"     This study is designed for patients diagnosed with Liver cancer to collect information about     the relationship between types of liver cancer, methods of treatment and outcomes over time.   "
133313|NCT01539980|"     1. Silk sericin wound dressing may reduce time for complete epithelialisation of          split-thickness skin graft donor sites compared to Bactigras®.        2. Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor          sites compared to Bactigras® .        3. Silk sericin wound dressing may not cause split-thickness skin graft donor sites          infection as compared to Bactigras®.        4. Split-thickness skin graft donor sites which treat by silk sericin wound dressing may          not cause significant adverse events.   "
133451|NCT01538173|"     In this prospective study we investigated the impact of an improved postoperative     microcirculation and its effect of surgical side infections after breast reduction.   "
133315|NCT01539954|"     The goal of this project is to develop a computerized screening program for primary care     offices that is based on the NIAAA's Alcohol Screening Guide for Children and Adolescents and     assess its psychometric properties among nine- to 18-yr-old primary care patients. There have     been few studies of alcohol screening and brief intervention conducted among adolescents     receiving primary medical care. This project will develop and validate a new computerized     Alcohol Screening for Children and Adolescents (cASCA) system based on the two age-specific     screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk     and problem assessments. The system will yield a provider report with the screening results,     level of risk, and recommended brief advice, counseling, or referral strategies. The Specific     Aims of this project are to: 1)Assess the sensitivity, specificity, positive and negative     predictive values of the 'any drinking/number of drinking days' and 'friends' questions of     the cASCA in identifying past-year use as determined by the Timeline Follow-Back Calendar     (TLFB), and for identifying any problem use, abuse or dependence as determined by the AUDIT,     CRAFFT and a structured psychiatric diagnostic interview (computerized DISC-IV, Youth     Version) at baseline (criterion validity); 2)Assess the test-retest reliability of the cASCA     in measuring drinking frequency categories and in classifying patients into Low, Medium and     High risk categories; 3)Assess the predictive validity of the 'any drinking/number of     drinking days' and 'friends' questions in predicting drinking, binge drinking, and any     problem use, abuse or dependence at 12-mos follow-up; 4)Assess the degree to which the 'any     drinking/number of drinking days' item of the cASCA predicts drug use risk as measured by the     TLFB (any use and frequency), tobacco use as measured by the Hooked on Nicotine Checklist     (screen for potential nicotine dependence), drug use disorders as measured by the Drug Abuse     Screening Test for Adolescents, and the degree to which it predicts other mental health     problems as measured by the Youth DISC Predictive Scales at baseline and 12-month follow-up;     5)Compare the psychometric properties of the cASCA across subgroups, including: age, gender,     race/ethnicity, practice type, provider type, and patient risks (e.g., those with/without     friends who drink); and explore the possible effects of the cASCA system on drinking at 3-,     6-, 9-, and 12-month follow-ups.   "
133316|NCT01539941|"     The goal of this proposal is to develop and pilot a brief protocol designed to systematically     integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD)     into behavioral treatment services for adolescent substance users with comorbid ADHD in     everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU)     that can significantly impede successful ASU treatment but is vastly under-diagnosed and     undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and     compliance is particularly difficult to achieve in high-risk adolescent populations.   "
133317|NCT01539928|"     The purpose of this study is to compare conventional PET/CT scan performed 1 hour after     injection of the radioactive tracer FDG (PET/CT[1]) with PET/CT performed after 3 hours     (PET/CT[3]) in a group of patients with biopsy verified lung cancer or high suspicion of lung     cancer after initial work-up (chest x-ray and CT of thorax/upper abdomen), who are     potentially operable.   "
133318|NCT01539915|"     This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic     patients to better understand the skin penetration of topically applied BCT194.   "
133319|NCT01539902|"     The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on     remission of lupus nephritis (combined partial and complete remission) in terms of     stabilization and improvement in renal function.   "
133329|NCT01539772|"     This is a multi-center natural history study that will be conducted at participating centers     in the Cooperative International Neuromuscular Research Group (CINRG). Following a baseline     evaluation, participants will have three follow-up visits over a three-year period. The     investigators will characterize the Becker muscular dystrophy phenotype, and correlate     specific abnormal dystrophin proteins with the range of clinical outcomes.   "
133919|NCT01531972|"     This is an open-label study investigating the relationship between SEP-228432 and SEP-228431     (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT     occupancy, both measured by SPECT imaging.   "
133320|NCT01539889|"     Pulmonary hypertension (PH) can be the result of various clinical conditions. It may be     idiopathic or associated with various cardiovascular and lung disorders. Currently there is     no test that can non-invasively detect abnormalities of the pulmonary circulation. There is a     growing need for a non-invasive method to detect PH. There currently exists only ne agent     approved in Canada for clinical imaging of the pulmonary circulation, 99mTc-labeled     macroaggregates. This agent is exclusively used for the diagnosis of physical defects of the     circulation due to pulmonary embolus. This agent is larger than small pulmonary vessels,     limiting its sensitivity to detect small vascular defects, as well as potential infectious     risks since albumin macroaggregates are derived from human albumin. There is need then for     new lung tracers that could provide a greater safety profile while enabling functional as     well as anatomical imaging of the pulmonary circulation. DFH-12 (PulmoBind) is a peptide     derived from human adrenomedullin (hAMI-52). Hence the development of this novel AM     derivative, PulmoBind, for molecular imaging of the pulmonary circulation. PulmoBind is     labeled with 99mTc, the most commonly used imaging isotope in nuclear medicine.   "
133321|NCT01539876|"     The purpose of this study is to assess the fine needle aspiration methodology in collecting     sufficient tumour cells to measure tissue TNFa levels serially in human breast cancer sample     receiving Taxane treatment   "
133322|NCT01539863|"     As low back pain is often a recurrent and sometime persistent problem, research into     prevention is important. Chiropractors have traditionally treated patients with maintenance     care, which means that patients are seen on a regular basis to prevent recurrences or to stop     a persistent problem getting worse. However, it is not known if this has the expected effect.      This study will test the effectiveness of the maintenance care approach. Patients with     recurrent or persistent low back pain will be treated in accordance with two different     models. The first model is the maintenance care model, meaning that chiropractors will see     the patient on a regular basis, regardless symptoms. The other model means that patients     should be treated patients only when they themselves experience symptoms bad enough to seek     care. After one year, it will be possible to see if there has been any difference between the     groups in terms of pain, disability, quality of life and total number of treatments over the     study period and to investigate if there is any difference in the cost-effectiveness between     the two treatment models.Thus, the study hypothesis is that there is no difference between     the two models regarding the number of days with pain.      This study will be a multi-centre trial, and as part of the study, it will be necessary to     formalize a network of research clinics all over Sweden in which participating chiropractors     accept to perform complex data collection. This network will then have the expertise and     potential to perform future clinical studies together with networks in other countries,     allowing large clinical trials across countries.   "
133323|NCT01539850|"     The main objective of this study is to evaluate the LGL102 implant safety in obese to     morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight     changes will be also evaluated.   "
133348|NCT01539512|"     This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of     idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor     control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible     patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either     idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary     study therapy but experience definitive CLL progression are eligible to receive active     idelalisib therapy in the extension study, GS-US-312-0117.   "
133685|NCT01535131|"     This study compares a standard method for palate repair (the Furlow palatoplasty) with a     modification of that method to determine which, if either, is more effective in reducing the     duration of middle-ear disease (fluid in the ear) in cleft palate patients.   "
133324|NCT01539837|"     Parkinson's disease (PD) is a common neurodegenerative disease affecting movement. Although     drug treatments for PD are available they only treat the symptoms of the disease, fail to     halt neuronal loss, and are associated with long term side effects and loss of efficacy.     There is a chronic need to develop neuroprotective therapies. Increased iron and oxidative     stress have been heavily implicated in the neurodegenerative process in PD, hence removal of     excess iron by iron chelation represents a potential drug target. Iron chelators are     extensively utilised to treat peripheral iron overload disorders (e.g. thalassaemia) and     recently the investigators have demonstrated iron chelators such as Deferiprone can enter the     brain removing excess iron and are neuroprotective in PD animal models. Although good     tolerability and efficacy to remove brain iron has also been shown in a pilot study with the     iron chelators Deferiprone in young patients with Friedreich Ataxia, where iron accumulates     in the dentate nucleus, no studies have been conducted in aged individuals affected by PD.     Hence the aims of this study are 1) to assess whether Deferiprone is well tolerated in PD     patients, 2) whether Deferiprone can remove the excess iron levels found in the brain area     affected by PD, the substantia nigra, as assessed by Magnetic resonance imaging (MRI) and 3)     whether Deferiprone has any direct effect on the clinical symptoms of PD. Three groups of 12     (total 36) early stage drug free PD patients will be treated with 20 or 30mg/kg/d Deferiprone     or Placebo for 6 months. Over the 6 months patients will receive serial MRI scans,     neurological examinations not only to assess PD symptoms but also psychological state, plus     blood test to monitor for potential side effects. Positive results from this pilot will help     support larger clinical trials to evaluate whether Deferiprone can slow down/halt PD.   "
133325|NCT01539824|"     The purpose of this study is to investigate the safety and effects of IMM 101 in combination     with a single targeted dose of radiation in patients with metastatic colorectal cancer in     whom chemotherapy or other treatment has not been effective. Administration of radiation     (using the CyberKnife) to the target tumour growth in the liver results in the release of     tumour material. IMM-101 may help the immune system to react to the tumour material released     from the damaged tumour, and so have a beneficial effect in slowing down the rate of growth     of other tumour growths in the liver and other organs.   "
133326|NCT01539811|"     This is a pilot study to explore the effects of long-course versus short course antibiotics     on wound healing in surgically managed diabetic foot infections. Hypothesis: Diabetic Foot     Infections (DFIs) are best managed with an early aggressive surgical approach and short term     antibiotic use. Post-operative prolonged antibiotic use increases costs and resource     utilization without improving outcomes.   "
133327|NCT01539798|"     The investigators conducted a cross-over study to compare the response of healthy young     volunteers to a rapid oral intake or intravenous infusion of 0.9% saline solution on the body     composition, serum electrolytes, albumin, and hematological parameters.      The investigators hypothesized that these parameters will differently adapt depending on the     route of infusion   "
134110|NCT01529463|"     The purpose of this study is to test the hypothesis that a comprehensive post-discharge     disease management system is more effective in reducing the readmission rate for heart     failure patients compared to standard care.   "
133330|NCT01539759|"     This is a randomized controlled trial among women who deliver by cesarean at UNC Women's     Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After     consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a     postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the     Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8     week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that     women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months     later than women who plan on receiving an IUD 4-8 weeks after delivery.   "
133331|NCT01539746|"     The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for     predilation of the native aortic valve is associated with a reduction of the composite     primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction     (LVEF ≤35%).   "
133332|NCT01539733|"     The investigators designed a randomised multicenter clinical trial for patients with advanced     cancer who are admitted to the medical oncology ward or high-care hospice. On admission all     patients with advanced cancer will be asked to participate in this study. Consenting patients     will be submitted to delirium observation screening according to the DOS. Subsequently DOS     screening will be performed twice weekly until discharge. Each patient who's score is > 3     (DOS positive) is showing significant symptoms of delirium and will be submitted to the     revised Delirium Rating Scale (DRS-R-98) to confirm diagnosis. To test validity of the DOS     scale for this particular population, each DOS positive score will be randomly matched with a     patient with a DOS score < 3 (DOSnegative) and this patient will also be submitted to     DRS-R-98. When diagnosis of delirium is confirmed by DRS-98, patients will be randomised     between treatment of delirium with olanzapine or haloperidol (usual care). Treatment in both     groups will consist of identification and management of underlying aetiologies of delirium if     possible and adding neuroleptic medication for symptom control. Patients who recover from     their delirium episode as well as their caregivers will be asked to complete the Delirium     Experience Questionnaire (DEQ) to assess recall of the delirium experience and the degree of     distress related to the delirium episode.   "
133403|NCT01538797|"     The objectives of the study were:        -  To compare a single dose of YF476 at 3 dose levels, placebo and ranitidine with respect          to their effects on basal- and food- stimulated gastric pH in healthy volunteers.        -  To assess whether there is a relationship between the pharmacokinetics of YF476 and          gastric pH in healthy volunteers.        -  To assess the safety and tolerability of single doses of YF476 in healthy volunteers.   "
133686|NCT01535118|"     This study will gather information on allergic rhinoconjunctivitis from surveys completed by     adults and children.   "
133333|NCT01539720|"     Unintended pregnancy rates in the United States are among the highest of developed nations.     These high rates can largely be attributed to incorrect or under contraception of women. One     focus of decreasing unintended pregnancy and abortion rates has centered on expanding access     to and use of long acting reversible contraceptive (LARC) methods which include intrauterine     devices (IUDs), and subdermal implants. Emergency contraception, or post-coital     contraception, offers significant reductions in the chance of pregnancy following an act of     unprotected or under-protected vaginal intercourse. The most common method of emergency     contraception used in the United States is the oral levonorgestrel regimen which reduces     pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine     device. The intrauterine device has the added benefit of providing extended contraceptive use     beyond the single episode of unprotected intercourse. The Cu-T380 has been associated with     heavier and more crampy menses however, likely dissuading women from use. Among all IUD     users, the levonorgestrel IUS has gained popularity over the Cu-T380, perhaps because it     offers the potential to improve menstrual related symptoms. There is no data however on the     efficacy of the levonorgestrel IUS as a form of emergency contraception. The purpose of this     study is to evaluate the efficacy of the LNG-IUS as a method of emergency contraception.     Participants will be randomized to receive either the most common method, oral emergency     contraception, or the LNG-IUS. Participants will then be evaluated 5-6 weeks following method     allocation for pregnancy. Lastly, participants will be asked to complete a telephone surveys     at 6 and 12 months following method allocation assessing their use of a consistent     contraceptive method, their satisfaction with their contraceptive method, any use of     emergency contraception since their enrollment in the study, and lastly any unintended     pregnancies experienced since enrollment in the study. If we could show that the     levonorgestrel IUS is as effective as the most commonly prescribed method of emergency     contraception, we would be introducing another opportunity for LARC initiation and     subsequently impacting unintended pregnancy and abortion rates.   "
133334|NCT01539707|"     The purpose of this study is to evaluate blood levels of solifenacin succinate (the study     drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If     the bladder contracts strongly and without warning, the muscles surrounding the urethra     (detrusor muscles) may not be able to keep urine from passing. This may happen as a     consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.   "
133335|NCT01539681|"     Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular     Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with     sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate     the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC     under daily-life treatment conditions.   "
133336|NCT01539668|"     This study evaluates the women cervical samples through molecular tests in order to:      1. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer     Hospital to evaluate their performance;   "
133337|NCT01539655|"     Study in healthy volunteers to assess effect of omeprazole and ranitidine on the     pharmacokinetics of vandetanib   "
133338|NCT01539642|"     The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA     System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute     moderate to severe post-operative pain after open abdominal surgery.   "
133339|NCT01539629|"     This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D     device to evaluate a new feature for future heart failure devices.   "
133340|NCT01539616|"     ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to     decrease triglyceride level and also correct dyslipidemia.   "
133341|NCT01539603|"     The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon     first and then bare metal stent compared with drug-eluting stent for treatment of de novo     lesions (DEB first).   "
133342|NCT01539590|"     The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function     following myocardial infarction (heart attack).   "
133343|NCT01539577|"     This study is a multicenter, prospective, observational study to evaluate the long-term     safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion     (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior     segment uveitis in real-world clinical practice.   "
133344|NCT01539564|"     The objective of the study is to evaluate the safety and effectiveness of Arestin     (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when     used in combination with mechanical debridement.      The hypothesis of the study is that Arestin in combination with mechanical debridement is     more effective in the treatment of peri-implantitis when compared to mechanical debridement     alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as     measured at qualifying implant sites.   "
133345|NCT01539551|"     B-type natriuretic peptide (BNP) is a cardiac neurohormone which rapidly released by the     ventricle in response to myocardial stretch. BNP has been used as a biomarker of sepsis     related cardiac dysfunction and volume overload in critical ill patients. It is also a marker     associated with prognosis in patients with severe sepsis and septic shock. However, the     clinical utility of BNP level in management of early severe sepsis and septic shock over the     first 48 hours is not clear. Besides, Lactate represents as a maker of tissue hypoperfusion,     which has been used as a guide therapy for sepsis patients and high serum lactate level is     independently associated with mortality in severe sepsis. Today, in management of early     severe sepsis and septic shock, current guideline emphasize the early goal-directed therapy     (EGDT) with achieving the central venous pressure (CVP) level 8-12 mmHg by fluid support     first, then targeting the next goal to maintain mean airway pressure (MAP) at least 65 mmHg     by vasopressor agent (ie, Norepinephrine) and finally keeping central venous oxyhemoglobin     saturation (ScvO2) > 70% via optimal Hct > 30% and dobutamine usage within first 6 hours of     emergency department admission. However, the role of BNP and lactate in patients with severe     sepsis and septic shock with or without myocardial dysfunction under EGDT management are not     clear.      The investigators will conduct a prospective observational study to investigate the change of     BNP and Lactate within 48 hours in early severe sepsis and septic shock under EGDT     management, their association of cardiac dysfunction and their role in predicting various     clinical outcome. The investigators also want to see if BNP and lactate could be useful tools     to guide the adjustment of optimal fluid supply and the timing of inotropic agent     intervention.   "
133346|NCT01539538|"     The study is intended to show that the Sufentanil NanoTab PCA System is as effective as     morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery.     Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat     their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.   "
133404|NCT01538784|"     The objectives of the study were:        -  To assess the safety, tolerability and pharmacokinetics of YF476 in healthy volunteers.        -  To select a dose or doses of YF476 for detailed pharmacodynamic studies in healthy          volunteers.   "
133350|NCT01539486|"     The intent for this study is to do a retrospective chart review of all patients who have     undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data     collected will be recorded under assigned identification numbers that will have no     association with medical record or hospital numbers. Identifying characteristics will include     age and sex. Anonymity will be upheld. The patient/family will not be contacted directly. All     information will be obtained from the medical chart. Demographics, location, preoperative PTH     levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and the outcome based     on the hospital notes will be obtained from patients' charts and will be transferred to a     secure database. It is our hypothesis that there is a linear relationship between immediate     preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and the aim of this     study is to better describe this relationship.   "
133351|NCT01539473|"     Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered     with tyramine   "
133352|NCT01539460|"     Patients with axillary osmidrosis are treated with minimally invasive procedure combined     tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in     reducing odor is to be determined.   "
133353|NCT01539447|"     In a brief summary the study would like to evaluate the effectiveness of Naproxen in     preventing radiographically detected heterotopic ossification following hip arthroscopy for     the treatment of femoroacetabular impingement.   "
133354|NCT01539434|"     The purpose of this study is to investigate to what extent patients with COPD, who have     participated in physical training for 12 weeks, can maintain their physical activity     behaviour and physical capacity on a long-term basis if they get a behavioural medicine     intervention.   "
133355|NCT01539421|"     This study was designed to evaluate the effectiveness of 12 weeks' home exercise training     using the Nintendo ® Wii Fit system in patients with COPD. Following an initial pilot study     at one institution to determine the physiological responses to exercise training using the     home based interactive computer system, a longitudinal study was performed to evaluate     outcomes across several areas. Outcomes were measured at baseline, after 6 weeks of standard     care, and after 6 and 12 weeks of home exercise training. Three hospital based pulmonary     rehabilitation centers in Connecticut participated in the longitudinal study.   "
133356|NCT01539408|"     Women diagnosed with incomplete abortion in this health facility will be randomized to     receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard     surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion     with misoprostol using 400 mcg administered sublingually will be as effective as surgical     evacuation.   "
133357|NCT01539395|"     This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple     Sclerosis.   "
133369|NCT01539239|"     This clinical trial is a prospective, randomized, controlled, multicenter, study. After     informed consent is obtained, patients will be evaluated for eligibility based on glaucoma     severity, eye health, and visual acuity. Following successful screening, use of all topical     glaucoma medications will be stopped for a period of washout to establish a qualifying     medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over     the course of the 24 month study, and examinations will be repeated to monitor eye health. At     the 1 and 2 year follow up, those patients on ocular hypotensive medications will be     instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and     afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The     primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24     months diurnal IOP following medication washout.   "
133358|NCT01539382|"     The purpose of this study is to test whether keeping the amount of oxygen delivered to the     brain above a certain level during surgery and 24-hours after surgery improves recovery.      Hypothesis 1: keeping the amount of oxygen delivered to the brain above a certain level     during surgery and 24-hours after surgery improves cognitive and neurological outcomes after     cardiac and aortic surgery.      Hypothesis 2: keeping the amount of oxygen delivered to the brain above a certain level     during surgery and 24-hours after surgery helps reduce major organ problems after cardiac and     aortic surgery.      To test our hypotheses, the investigators will conduct a randomized control trial. Patients     will be randomly assigned to one of two possible study groups. In the Treatment Group, the     brain oxygen level will be watched by doctors and used to guide care in the operating room     and the first day in the intensive care unit after surgery. Doctors will try to keep the     brain oxygen level in a normal range by adjusting your blood pressure, carbon dioxide and     blood acidity levels, and blood count. In the Control Group, the doctors will not be aware of     the brain oxygen level unless it falls below a level that may be dangerous. If a patient's     brain oxygen falls below such a level, the doctors will adjust the blood pressure, carbon     dioxide and blood acidity levels, and blood count to increase the brain oxygen level. All     other procedures will be part of regular medical care and will be performed according to the     standard of care.   "
133359|NCT01539369|"     The purpose of this parallel design study is to assess the relative effects of two 12-week     healthy eating dietary interventions: general healthy eating (Diet A) and general healthy     eating combined with advice to increase fibre intake (Diet B) to at least 25g/day (with a     large proportion of the fibre intake derived from cereal or wheat bran), in overweight     low-fibre consuming premenopausal female adults on body weight change (kg). It is     hypothesized that adding fibre to a healthy eating diet (Diet B) would lead to greater weight     loss and/or weight loss maintenance than following a healthy eating diet alone (Diet A).   "
133360|NCT01539356|"     A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of     iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron     retention in reticuloendothelial cells. The aims of this study were to determine serum     hepcidin levels in preterm infants who receive blood transfusion and preterm infants having     sepsis, in order to assess possible relationships between hepcidin and serum iron, serum     ferritin,in iron load situations.   "
133361|NCT01539343|"     A CVC is a sterile flexible tube that allows a drug to flow from a bottle or bag directly     into a patient's bloodstream. CVCs may cause infections when bacteria gets into the catheter     and enters the bloodstream. They also have a risk of becoming clogged. When this occurs, the     CVC usually needs to be replaced.      The goal of this clinical research study is to learn if an antimicrobial catheter lock     solution can make it possible for the CVC to stay in place while treating an infection with     antibiotics. The safety of the solution will also be tested.      Your outcome will be compared to the outcome of patients who had the same type of infection     but had their CVC removed.      The antimicrobial catheter lock solution is made up of 3 chemicals:      Minocycline and ethanol are designed to disinfect the CVC. Disodium     ethylenediaminetetraacetate is designed to prevent the CVC from clogging.   "
133375|NCT01539161|"     The study Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients     with Chagas Disease is a prospective, multicenter, randomized study that is being conducted     at several centers in Latin America with commercially available products.      The primary study hypothesis is that patients with implantable cardiac monitors will have a     shorter time to the decision to treat for electrical or arrhythmic disorders during the     follow-up period.      The geography includes Argentina and Colombia.   "
133362|NCT01539330|"     The present study aims at measuring unbound voriconazole concentrations in plasma and at the     relevant target site of systemic fungal infections, i.e. the interstitial space fluid of soft     tissues, to assess the target site pharmacokinetics. For this purpose the microdialysis     technique will be employed which is capable of measuring the unbound, microbiologically     active concentration of antifungals in the interstitial space fluid of virtually all tissues.     This is the first human study of this drug employing the microdialysis technique determining     the target site concentrations over several days (single and multiple dosing).   "
133363|NCT01539317|"     The purpose of this protocol is to determine whether pain with sexual intercourse can be     reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a     non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.      The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators     predict that the localized use of lidocaine will be more efficacious than use of placebo     liquid.   "
133364|NCT01539304|"     Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of CITUS Dry     Syrup in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo     Controlled, Parallel Designed, Multi-centered, Phase III Study.   "
133365|NCT01539291|"     This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension     study that is a companion study to Study GS-US-312-0116, to evaluate the effect of idelalisib     on the onset, magnitude, and duration of tumor control.   "
133366|NCT01539278|"     In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep     apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the     tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure the     majority of children. However, for children with only a mild degree of OSA and few symptoms,     surgery is less clear-cut, since two-thirds of these children do not develop worsening     disease.      Research shows that some children with mild OSA and behavior problems are helped by removing     the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores on     tests that measure quality of life (QOL).      The investigators hypothesize that children with mild OSA will demonstrate changes on QOL     assessment following adenotonsillectomy. These findings may help to guide the surgeon in     selecting the children with mild OSA who are more likely to benefit from surgery.   "
133367|NCT01539265|"     The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary     calculi patients.   "
133368|NCT01539252|"     The purpose of this study is to investigate the effectiveness of using two dialysers to lower     the blood mineral levels in people receiving hemodialysis as compared to using one dialyser     (usual treatment).   "
133371|NCT01539213|"     The proposed exploratory study aims to understand the in vivo skin distribution properties of     subcutaneously (s.c.) administered AIN457 in psoriatic and healthy skin using open flow     microperfusion (OFM). The data of this study will help to understand the mode of action of     AIN457 in its target tissue.      It aims to establish a technique assessing in vivo distribution of AIN457 and its metabolites     in human dermal interstitial fluid (ISF) and exploring a potential pharmacodynamic effect in     situ. In addition, the study will further evaluate safety and local tolerability of     subcutaneously administered AIN457 and explore dermal interstitial fluid skin levels of     potential disease relevant biomarkers.      The study is divided into two parts - Part I with 8 healthy volunteers (HV) to validate the     method is completed and Part II with 8 psoriasis patients will start based on the outcome of     Part I.   "
133372|NCT01539200|"     Malnutrition and lack of regular exercise are often found in older adults and have been     identified as important risk factors for independence loss and nursing home admission in     older community-dwelling adults.      Existing evidence suggests that high protein nutritional supplements can increase skeletal     muscle protein synthesis following exercise in older individuals. However, increase of muscle     strength by resistance training does not decrease the rate of falls and is not necessarily     linked to an improvement of physical function. In contrast to resistance training, T'ai Chi,     dance and eurhythmics have been shown to decrease fall incidence and improve mobility and     physical function in older adults. The investigators will examine the combination of     eurhythmics and high protein nutritional supplements.      The aim of the study is to investigate whether there is an increase in normal walking     velocity due to the nutritional supplement on top of once weekly Jacques-Delacroze     Eurhythmics training.   "
133373|NCT01539187|"     The purpose of this study is to establish the effectiveness and confirm the safety of the     VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.   "
133374|NCT01539174|"     This phase II trial studies how well giving rituximab together with combination chemotherapy     works in treating patients with previously untreated high- or high-intermediate-risk diffuse     large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer     growth in different ways. Some block the ability of cancer to grow and spread. Others find     cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and     prednisone (CHOP), work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Giving more than one drug, combination     chemotherapy, may kill more cancer cells. Giving rituximab together with combination     chemotherapy together may be an effective treatment for DLBCL   "
133376|NCT01539148|"     The investigator is looking for patients who have been diagnosed with stage 1-4 cancer to     enroll in a five year Quality of Life clinical trial study in which the participant has     previously elected to use Insulin Potentiation Targeted Low Dose (IPTLD) as a means to treat     their illness. This study is a quality of life study and not a treatment study. Participants     participating in the study will be asked to complete quality of life questionnaires. The     questionnaires completed by the patients will measure mood, energy level, ability to     function, level of pain, and other measures that indicate how a patient feels about the     quality of their daily living.   "
133377|NCT01539135|"     Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe     while under general anesthesia. These tubes have a cuff on the outside that is inflated in     the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different     shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been     shown in animals to decrease the leakage of fluid past the cuff better than a traditional     tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the     TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a     greater degree than the traditional barrel-shaped cuff. In addition, the study will     investigate whether the use of the TaperGuard tube is associated with a decrease in     respiratory complications often seen following surgery which may be related to fluid leaking     past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal     tube will result in a decrease in fluid leakage past the cuff and that it will be associated     with a decrease in respiratory complications during the 30 days after surgery.   "
133378|NCT01539122|"     The objective of this randomized controlled study is to obtain outcomes data on the Zimmer TM     glenoid component by analysis of standard scoring systems and radiographs in comparison to     the cemented glenoid component. In addition, the investigators plan to provide cost analysis     based on the economic data collected to justify the cost difference between both implants.      Patients with acceptable glenoid bone stock will be randomized into two groups to be treated     with either a TM Glenoid or cemented glenoid component with minimum 2 years follow-up;     maximum 10 years follow-up.      Hypothesis: The early and long-term clinical outcomes and radiographic analysis of the TM     glenoid components are superior to the cemented glenoid components in total shoulder     arthroplasty patients.   "
133379|NCT01539109|"     The purpose of this study is to investigate whether combining a noninvasive method of brain     stimulation, called Transcranial Direct Current Stimulation (tDCS), enhances the effect of     training of the affected upper limbs in patients with incomplete Spinal Cord Injury.   "
133380|NCT01539096|"     The purpose of this study is to investigate whether benefits of training the affected hand in     patients with stroke can be improved by combining training with a painless, noninvasive     technique called Transcranial Direct Current Stimulation (TDCS). TDCS will be applied over     the part of the brain responsible for movements of the affected hand. Also, the investigators     will study the changes in the brain that favor recovery of hand function following     combination of training and tDCS.   "
133381|NCT01539083|"     The purpose of this study is to determine if bortezomib when added to consolidation treatment     with thalidomide and prednisolone leads to an improved response in patients with multiple     myeloma who have undergone autologous stem cell transplant and initial treatment with     bortezomib, cyclophosphamide, and dexamethasone.   "
133382|NCT01539070|"     The purpose of this study is to develop, implement and evaluate an intervention focused to     change feeding practices and patterns of physical activity of preschool children through     providing motivational counseling to the mother. The aim is to prevent obesity in children     aged 2 to 4 years 11 months with risk of overweight or with overweight.   "
133383|NCT01539057|"     Objective:        -  To evaluate the efficacy of preoperative administration of fibrinogen in liver          transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared          with placebo, reflecting a reduction in the number of RBC units transfused during the          procedure.        -  To determine the influence of fibrinogen administration on mortality and survival of          liver graft evaluated one year after the procedure.        -  To determine the safety of fibrinogen administration recording thrombotic complications          evaluated during hospitalization or at least 30 days postoperatively.   "
133384|NCT01539044|"     Muscle relaxation using rocuronium infusion with sugammadex reversal hypothetically provide     better quality of muscle relaxation and rapid recovery from anaesthesia compared with     intermittent bolus of rocuronium muscle relaxant which is reversed with neostigmine.      50 patients undergoing major laparotomy surgery with predicted surgical time of more than 90     minutes will be randomised into 2 treatment arms: CI-sugammadex & IB-Neostigmine.      After a bolus of rocuronium given during induction, patients in CI-Sugammadex arm will be     started on rocuronium infusion immediately and rate adjusted according to the targeted PTC of     1-2. Patients randomised to IB-Neostigmine will be given boluses of rocuronium at     reappearance of TOFC of 2.      At the end of the surgery, the subject will be reversed with either sugammadex or neostigmine     at different depth of block, ie PTC 1-2 and TOFC 2 respectively.      Quality of intraoperative relaxation and effectiveness of reversal of the 2 technique,     CI-Sugammadex and IB-Neostigmine will be compared with respect to:        1. Time to full reversal (T4/T1 [TOF] ratios ≥ 0.9) of neuromuscular blockade from:             -  PTC 1-2 in CI-Sugammadex group             -  TOFC ≥2 in IB-Neostigmine group        2. Incidence of residual neuromuscular blockade (T4/T1 ratios < 0.9)        3. Improved quality of intraoperative neuromuscular relaxation by maintaining profound          neuromuscular blockade, as reflected by reduced incidence of intraoperative events and          high VAS grading of relaxation quality by surgeon   "
133385|NCT01539031|"     The purpose of this study is to compare 23 mg donepezil sustained release to the currently     marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's     disease.   "
133398|NCT01538862|"     This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is     effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one     course of treatment with the study drug. The course will be 7 days in length. After receiving     GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug.     Thirty day follow up can be done via telephone communication with the patient or family.   "
133386|NCT01539018|"     -  Unlike the Asian and western regions, The vast majority of the Egyptian/Arabic          Hepatocellular Carcinoma (HCC) patients are hepatitis C virus (HCV) associated.        -  According to the SHARP study subgroup analysis, it seems that HCV associated HCC          patients derive the max benefit of Sorafenib, the absolute gain between the Sorafenib          arm & the placebo in m OS = 7 months, HR=0.58 (95% CI: 0.37-0.91).        -  In spite of improvement in terms of overall survival (OS) and time to progression (TTP),          in all studies where Sorafenib was compared to placebo, the Sorafenib arm was not          accompanied by a significant volumetric reduction, and this may explains the lack of any          symptomatic improvement (time to symptomatic progression (TTSP) almost identical)        -  Reviewing the chemotherapy outcome, although there is no convincing evidence in survival          benefit to patients with advanced HCC, however true shrinkage (reduction in tumor size),          has been consistently reported although the magnitude of response is lacking          consistency.      This indicates the need for coupling Sorafenib to a chemotherapeutic agent but:        -  For patients with Hepatocellular Carcinoma, the toxicity profile of any chemotherapeutic          agent of choice to be added to Sorafenib should be take in consideration        -  The agent to be added to Sorafenib should be effective in terms of Tumor Shrinkage &          with minimal toxicity regarding:        -  Cardio-toxicity        -  HFSR        -  Diarrhea        -  Hepato-toxicity        -  Bone marrow suppression (although not relevant to the toxicity profile of Sorafenib, yet          the HCC patients may have HCV related thrombocytopenia and variable degree of          hypersplenism related pancytopenia)      Circulatory Overload (Hypertension) Why Tegafur-uracil (UFT)?        -  Efficacy: For UFT, although the efficacy data in HCC are not as extensive as          Doxorubicin, however in one phase II study UFT could improve survival when compared with          conservative management.        -  UFT Toxicity Profile:      In a phase III trial to asses the compare Efficacy & Safety of UFT with that of 5 FU in     treatment of m CRC, Hematological toxicities were minimal (0% Grade ¾ leukopenia,     neutropenia, febrile neutropenia, thrombocytopenia & was 3% for anemia), while the most     commonly seen SE was grade I & II Diarrhea      •Accordingly UFT may be considered as a potential partner to Sorafenib in patients with     advanced HCC.   "
133387|NCT01539005|"     This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence     in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly     active antiretroviral therapy (HAART).The primary objective of this study is to determine the     incidence of TB recurrence in patients on HAART.The study is being conducted at the CAPRISA     eThekwini Clinical Research Site (CRS), which is adjacent to the Prince Cyril Zulu     Communicable Disease Clinic (PCZCDC), a major urban TB clinic, in Durban, South Africa.No     hypotheses will be tested in this study; however, the primary study question will determine     the proportion of TB recurrence due to relapse vs. re-infection.The study has enrolled 402     participants   "
133388|NCT01538992|"     Sympathetic system has important role occurrence of symptoms in heart failure. Renal     denervation that is ablated some of sympathetic nerves is affected pathology of heart     failure. This interventional therapy improves symptoms and life quality.   "
133389|NCT01538979|"     The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It     will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off     allergy symptoms over a two year study period.   "
133390|NCT01538966|"     In this study the investigators will evaluate whether combination low dose somatostatin     receptor ligand (SRL) and weekly or daily Pegvisomant will attain equivalent control of serum     IGF-1 levels, compared to combination high dose SRL and weekly Pegvisomant. Lower doses of     therapy will greatly reduce cost of acromegaly therapy.   "
133391|NCT01538953|"     This study is designed to evaluate the effect of different methods of drinking water     treatment on the occurrence of diarrhea among children living in squatter settlements in     Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260     households will receive a new product which combines flocculation with chlorination to     produce clearer, less chemically contaminated drinking water. 260 households will receive     dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive     soap and encouraged to wash their hands regularly. 260 households will receive both soap and     the combination flocculation/chlorination water treatment. 260 households will continue their     standard water treatment and handwashing practices. The households will be visited each week     for 9 months, and the episodes of diarrhea from each child in the household recorded. The     rate of diarrhea between the groups will be compared. At the end of 9 months, households who     were part of the standard habits and practice group will receive a water storage vessel and     disinfectant.   "
133392|NCT01538940|"     This study will assess the efficacy of a new intradermal formulation of the trivalent     inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected     men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different     formulations of influenza vaccine will be assessed by comparing immunologic responses to     vaccine between the two study arms.   "
133393|NCT01538927|"     The aim of this randomized controlled clinical trial is to compare wound healing after the     use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for     their periodontal (gum)problems are selected and invited. Two regions will be operated in a     selected patient. One region will receive fibrin sealant (test site) and the other region     will get sutures (control site). Wound healing will be assessed by evaluating inflammatory     markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.      Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels     of interleukin (1beta and 8) compared to use of sutures.   "
133394|NCT01538914|"     The purpose of this study is to compare the analgesic effect of paravertebral block with that     of intravenous patient-controlled analgesia after video assisted thoracic surgery.   "
133395|NCT01538901|"     The purpose of this study is to compare two different therapies for actinic keratoses in     organ transplant recipients with regard to efficacy and tolerability. The investiagtors are     planning to examine treatment with Imiquimod 5% cream versus treatment with     Methyl-aminolaevulinate 16% cream and subsequent irradiation with red light, so-called     photodynamic therapy, in this patients' group. A secondary objective of our study is to     investigate the reduction in the field cancerisation after both treatments using fluorescence     diagnostic method and digital imaging.   "
133396|NCT01538888|"     This study makes sure that the training of whole body vibration induces changes in     ergospirometric parameters, in strength and influence in quality of life in healthy elderly.     A case that is run like a vibration training combined, increasing strength and VO2.   "
133397|NCT01538875|"     Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure >     110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with     severe and even deadly consequences. The management in this population had been studied, but     no consensus has been reached with regards to which treatment is better. Our study will     compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.   "
133405|NCT01538771|"     Prospective, randomized and open label trial      Hypothesis        -  Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce          infarct size and post-infarct pathologic left ventricular remodeling in patients with          ST-segment elevation myocardial infarction.      Methods        -  Randomization into control group or treatment group        -  Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire          balloon system simultaneously with first balloon inflation and conventional treatment        -  Control group : conventional treatment      Endpoints        -  peak CK-MB & troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr        -  MRI at baseline : infarct size, area at risk and salvaged myocardium        -  MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition:          increase of end-diastolic volume index > 20% compared to baseline)        -  safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis,          ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding          and urgent target lesion revascularization   "
133406|NCT01538758|"     Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain     due to calcifying tendinitis. However, evidence for this treatment is lacking. The     investigators expect that patients treated with us guided needling with corticosteroid     injection compared with patients treated with only corticosteroid injections in the     subacromial bursa have better clinical outcome after one year follow-up.   "
133407|NCT01538745|"     The purpose of this study is to compare the safety and effectiveness of intravenous low dose     ketamine to the industry standard of morphine in regards to controlling acute pain in the     emergency department.      Both LDK and morphine have side effects. The amount and character of these side effects will     be compared. Additionally, the degree of sedation or agitation will be specifically measured.     The aim of this current study is to make this comparison and shift the evidence for LDK use     from the anecdotal to the scientific.   "
133408|NCT01538732|"     This is a single center, prospective, open label, single arm, investigator initiated pilot     study investigating the effect of alitretinoin on severe lichen planus with mucosal     manifestations. The target population comprises patients with MLP for at least 3 months, with     or without LP lesions on other areas of the skin, who are refractory to topical therapy and     standard skin care, and who are otherwise in good health. Patients will be recruited at the     outpatient clinic of the dermatology department, University hospital Zurich.The planned     duration of the study is 2 years. A total of 20 patients will be included. Patients who meet     enrolment criteria will receive 30mg alitretinoin, given orally as gelatin capsules, once     daily for 24 weeks. Dose interruptions are permitted in response to adverse effects,     consistent with use of retinoids and the product label.      Most clinical evaluations will be performed every 4 weeks. A safety follow-up visit is     planned 4 weeks after the end of treatment. Further follow-up visits will be conducted 16 and     24 weeks after end of treatment in those patients meeting the primary endpoint        -  Trial with medicinal product   "
133418|NCT01538602|"     Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and     hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia     and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term     cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the     thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of     metabolic outcomes in PCOS patients is compared to a placebo group.   "
133419|NCT01538589|"     This study is conducted in Japan. The aim of this study is to evaluate the incidence of     severe hypoglycaemia under normal clinical practice.   "
133420|NCT01538576|"     This study is conducted in Japan. The aim of this study is to collect safety and efficacy     data when using insulin aspart in children with diabetes under normal clinical practice     conditions.   "
133421|NCT01538563|"     The primary purpose of this study is to determine the highest dose of ON 01910.Na that can be     safely given as an intravenous infusion over 24 hours once a week in a 3-week cycle to     patients with advanced solid tumors.   "
133409|NCT01538719|"     Scleroderma,also known as systemic sclerosis (SSc), is a multisystem disease affecting skin     and other tissues including joints, muscles, lungs, the gastrointestinal tract and kidneys     and tissue fibrosis is widespread. SSc presents special problems for developing therapies due     to the heterogeneous clinical presentation, the variability of disease progression and the     difficulty quantifying the extent of disease. For most disease manifestations, treatment is     primarily symptomatic and generally inadequate.      This study will utilize a 4-gene biomarker of skin disease as the primary efficacy outcome in     a short duration, placebo-controlled clinical trial of rilonacept, designed to provide     preliminary data for a larger trial. These gene biomarkers should provide a strong surrogate     for such trials in the future and, if IL-1 is indeed the cytokine leading to fibrosis in this     disease, provide a highly significant start to finding a therapeutic for SSc that for the     first time might dramatically affect fibrosis. A central hypothesis of this study is that     IL-1 inhibition will downregulate the 4-gene biomarker over a relatively short period of     time, much shorter than is historically thought necessary to see changes in the MRSS, a skin     score measurement tool. Entry criteria will include the recent onset of diffuse cutaneous SSc     as this is the population most likely to show progressive skin disease and also the     population examined in previous studies showing correlations between MRSS and the 4-gene     biomarker.      Secondary outcomes will include other validated measures of SSc disease activity. MRSS and     SSc health assessment questionnaire (SHAQ), will be followed during the trial. This study     will also test the effect of rilonacept on global skin gene expression using microarray     analyses of skin biopsies. In addition, serum biomarkers of SSc disease activity (COMP, THS-1     and IFI44) and a biomarker of inflammasome activation (CRP) will be tested before and after     treatment.   "
133410|NCT01538706|"     The purpose of this non-randomized controlled intervention study was to evaluate the effects     of a hospital-based home care program for children with cancer at a university hospital in     Denmark. The hypothesis was that hospital-based home care could replace an out-patient visit     or an in-patient admission without increasing the incidence of adverse events and costs.     Furthermore, to enhance the children's quality of life and the psychosocial impact on the     family.   "
133411|NCT01538693|"     The purpose of this study is to determine whether exercising (walking) at different     intensities increases levels of factors in the blood and saliva that are known to impact     neuroplasticity (how the connections in the spinal cord and brain can change) and if these     levels are changed by pairing exercise with a single dose of commonly used prescription drugs     or by your mood.   "
133412|NCT01538680|"     This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study     to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have     failed after standard therapy and for whom no therapy alternatives exist, in the time between     positive results and approval / availability on the market, and to collect safety data for     regorafenib until market access.      Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase     inhibitor targets certain key proteins that are essential for the survival of the cancer     cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The     growth of the tumor may be decreased by preventing these specific proteins from functioning.      The primary endpoint of this study will be safety.   "
133426|NCT01538498|"     -  Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer,          tubal cancer and primary peritoneal cancer that can represent perioperative          intraperitoneal tumor burden objectively        -  Secondary objectives: To establish the relationship and find out clinical significance          between PCI, tumor location and tumor characteristics   "
133427|NCT01538485|"     In this pilot study the investigators aim to investigate the effects of vitamin D     supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women     and men.   "
133413|NCT01538667|"     The purpose of this study is to characterize variability and extent of the deposition of     ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with     chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg     active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be     evaluated. In this study the radiolabeled substance will be administered and scintigraphy     imaging techniques will be used to demonstrate the lung deposition visually. In the healthy     subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly     based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a     separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The     latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in     the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block).     Safety investigations will focus on local tolerability in the lung.      Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the     study drug.      Results from this study will be used to show how the drug is distributed in the human lung.   "
133414|NCT01538654|"     The purposes of the esperience is:        1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF          )performed in cycles of ten days/months for six months        2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance,          polmonary function tests and metabolic pattern)        3. to verify the weight mantainance after 6 months from the treatment suspension   "
133415|NCT01538641|"     Study Proposal:      Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol,     Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity     as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more     attractive and should be explored in this group of disorders. Based on these data and     considering the advantage of its favorable toxicity profile, we propose a phase II study in     patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including     peripheral T-cell lymphomas which are known to have a poor outcome when compared with     equivalent aggressive B-cell lymphomas.   "
133416|NCT01538628|"     The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel     is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and     to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure     to the anterior rectum.   "
133417|NCT01538615|"     The goal of the proposed project is to see if an innovative family-based intervention can     reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors     in the home. In additions, the project will also examine how the HOME Plus family     intervention influences children's dietary intake, frequency of family meals, availability of     healthy and unhealthy foods in the home and served at meals and snacks, and screen time (TV,     game systems). The study will provide important information on strategies that families can     use at home to prevent obesity.   "
133422|NCT01538550|"     The Norwegian government has funded a pilot study of a national colorectal cancer screening     programme. This implies initiation of a screening pilot in the catchment area for two     hospitals in Norway. The target population is average risk men and women at age 50-74 years.     The programme is designed as a comparative effectiveness programme evaluating acceptance and     test performance for two screening methods - fecal occult blood testing (FOBT) and flexible     sigmoidoscopy (FS). This protocol describes the main methodological issues, necessary     resources and the expected effects.   "
133423|NCT01538537|"     The primary objective of this study is to determine the largest dose of ON 01910.Na     (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2     weeks (2-week cycle) in patients with advanced cancer.   "
133424|NCT01538524|"     Patient safety is a great concern for the whole society. Since the investigators have a     leadership in the medical field in Taiwan, the investigators should be courageous to face the     reality from the patients seeking second opinions undergoing orthodontic treatment.      Orthodontics just became a recognized specialty by the Department of Health in Taiwan in     2009. It is just a beginning to set up the training course criteria at the national level. It     will be a good timing for us to look at the treatment quality when patients seeking second     opinions at NTUH. Whether the unsatisfied results are from the patient's unrealistic     expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills, or     a simple communication problem, depend on a good systemic analysis from the records and     questionnaire collected in a timely fashion.      The investigators plan to ask patients who are undergoing full-mouth orthodontic treatment     and seeking second opinion to join this study. The investigators will thoroughly explain to     patients before they agree to take records and fill in questionnaire. Then the investigators     use these records to perform root cause analysis.      Our hypothesis is that the risk of adverse event (AE) is related to the training quality,     communication skills, patient's understanding and compliance. From these results, the     investigators shall be able to assess the risk of AE and make the education policy either at     continued education level or special training courses towards a patient satisfied treatment.   "
133425|NCT01538511|"     This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart     70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30     (NN-X14Mix30) in healthy volunteers.   "
133429|NCT01538459|"     The purpose of this study is to determine the Finger Blood Glucose (sugar) when dexamethasone     is added to a local anesthetic for a shoulder nerve block procedure. The investigators     hypothesize that there is no increase in plasma glucose when 8 mg of dexamethasone is used as     an adjuvant with local anesthetic to interscalene regional anesthesia. By performing finger     stick blood glucose measures pre/peri and post operatively the investigators will be able to     determine if any such increase exists.   "
133430|NCT01538446|"     The purpose of this study is to demonstrate the superiority of a strategy of platelet     monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders     and up-adjustment of the dose of prasugrel in low responders as compared to a more     conventional strategy of a fixed dose of 5 mg to every patient without monitoring     (Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular     (CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type     definite), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).   "
133431|NCT01538433|"     This is a survey of factors which affect a pathologically defined early or delayed diagnosis     of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed     diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford     classification of IgA nephropathy. The factors to be surveyed include health examination     including urine test, socioeconomic status of patients including education,etc.   "
133432|NCT01538420|"     GLPG0492 is a selective androgen receptor modulator: the compound should help protect against     (or help restore) muscle loss in case of immobilization (e.g. after orthopedic surgery) or     due to aging (androgenic effect), but without anabolic effects (e.g. effect on testosterone).     In the first part of the current study it will be tested whether GLPG0492 given orally to     healthy male volunteers increases the protein synthesis in muscle, as measured by the uptake     into the muscle of intravenously infused phenylalanine.      In the second part of the study, the effect of the compound on the hormone household in     healthy, postmenopausal women will be assessed.   "
133433|NCT01538407|"     This is a longitudinal, randomized, controlled interventional multi centric study on the     effects of lower leg strengthening exercise on quadriceps force during walking in people with     knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40     participants. Subjects will be randomized equally (1:1) into 1 active arm and 1 control arm.      The objective of the study is to evaluate the effect of twelve weeks of quadriceps     strengthening on the mechanical output of the quadriceps during locomotion. A secondary     purpose is to explore the relationship between quadriceps strengthening and compressive knee     loadings. The hypothesis is that quadriceps strength training will not change quadriceps     force, power, and work in locomotion in people with knee osteoarthritis.      Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power     and work and knee compressive loads during walking. Explorative measures are isometric and     concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and     Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up test     (maximum number of reps).   "
133434|NCT01538394|"     The purpose of this study is to assess the efficacy of smoking cessation by using varenicline     as monotherapy (VRN + placebo patches) or combined therapy (VRN + nicotine patches).   "
133435|NCT01538381|"     The general objectives are to evaluate the pre-operative activity and the safety of afatinib     in head and neck cancer and to explore the different downstream molecular pathways to     identify tumor response and resistance mechanisms. The results from this study can be used to     conduct a larger trial that would allow us to confirm or validate the hypotheses generated.   "
133507|NCT01537445|"     The purpose of this study is to evaluate the beneficial effect of pancreas transplantation     for long term kidney function in patients undergoing single-pancreas transplantation.   "
134049|NCT01530256|"     The purpose of this study is to determine the safe and tolerable, biologically active, and     potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to     respond to glucocorticosteroids, for further investigation in Part B.   "
133436|NCT01538368|"     The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is     primarily performed by radiologists who only in some cases have experience with the     interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images. It is unclear     if MRCP-interpretation by the radiologist is sufficient to decide which additional endoscopic     procedures might be necessary in an individual case or if an additional MRCP-interpretation     by the endoscopist renders any clinical impact.   "
133437|NCT01538355|"     It is well accepted that nutrition as an environmental factor is involved in the pathogenesis     of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic     load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes     there is. Primarily the investigators want to detect if these diets are feasible for MS     patients. Therefore the investigators examine the impact of this dietary intervention on the     health related quality of life for individuals after 7 days, 3 months and 6 months in compare     to baseline. Secondarily the investigators focus on endocrinological and immunological     changes after 7 days, 3 months and 6 months in compare to baseline.   "
133438|NCT01538342|"     Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory     caspases, cysteine proteases involved in the processing of many proteins, are activated.     Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src family,     develop an inflammatory syndrome with the characteristics of human psoriasis.      To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the     investigators intend to develop a clinical study to analyze the expression, cleavage and     activity of Lyn and the activation of caspases from skin biopsies of patients with this     disease.      This study will be conducted on a cohort of patients with different forms of psoriasis     (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated     with chronic inflammation. Thus, the investigators will evaluate the expression and activity     of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the     level of caspase activation and apoptotic inflammatory.      Thus, the investigators will verify that the cleavage by caspases of Lyn is associated     specifically with psoriasis, as the investigators believe, or more generally to the skin     inflammation. The investigators work would then define the cleavage by caspases of Lyn as a     new potential marker of human psoriasis.   "
133452|NCT01538160|"     Lately the investigators found that patients with severe factor XI deficiency and inhibitors     could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic     agent. These results encourage us to apply this treatment in clinical trial setting to     patients with severe factor XI deficiency undergoing surgery instead of blood product.   "
133439|NCT01538329|"     Traditionally amantadine is used at the beginning of Parkinson Disease (PD) treatment in the     early stages of the disease, as a modest antiparkinsonian symptomatic treatment. This     treatment is usually maintained for no more than the first few months of management, before     resorting to drugs deemed more effective as dopamine agonists and lévo-DOPA (L-DOPA). A more     modern use of the drug is at a more advanced stage of PD when dyskinesia are already     established and become disabling for the patients. There is no data between these two     extremes of life stages of Parkinsonism. However, the mechanisms of action of amantadine and     the pathophysiology of the motor complications induced by L-DOPA, in particular dyskinesia     suggest that the early and prolonged use of amantadine in the early years of management,     before L-DOPA-induced dyskinesia have already emerged, should have a positive impact on     long-term occurrence and fate of these symptoms, possibly through a glutamatergic mechanism     of brain plasticity-of the disease modification type.      The primary purpose of this study is to demonstrate that early introduction of treatment with     amantadine (200 mg / d) in the early years of therapeutic care, that is to say during the     honeymoon of levodopa (early phase of disease <3 years of diagnosis <1 year of L-dopa and     lack of complications of levodopa therapy) decreases the rate of subjects with abnormal     involuntary dyskinetic movements after 18 months of follow-up.   "
133440|NCT01538316|"     The aim of the randomized controlled double-blind crossover trial is to evaluate the     effectiveness of two dietary supplements containing polyphenolic phytochemicals (isoflavonoid     genistein and flavonoid quercetin) in comparison with placebo on the rate of increase in     prostate-specific antigen (PSA). In addition, secondary objective is to evaluate the     incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as     indicators of the oxidative status.   "
133441|NCT01538303|"     The purpose of this study is first to evaluate absolute myocardial blood flow and resistance     over time in the acute and sub-acute phase of myocardial infarction and second, to correlate     these parameters to preservation of left ventricular function and long-term outcome.   "
133442|NCT01538290|"     The investigators want to validate two non-invasive devices for the determination of central     blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).   "
133443|NCT01538277|"     The knowledge of the real-time contact force leads to a greater reduction in atrial     fibrillation burden after pulmonary vein antrum isolation.   "
133444|NCT01538264|"     The investigators are studying the use of an advanced magnetic resonance imaging (MRI)     technique for measuring blood flow into brain tumors. This technique does not use radioactive     tracers, and it can provide high quality images that can be obtained in a standard MRI     scanner.   "
133445|NCT01538251|"     The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine     modified release tablets 1g/die in reducing the symptoms of the disease with respect to the     proportion of patients with disease remission at the end of the 8 weeks of treatment. It will     also aim to investigate capability of the treatment in the maintenance of remission after     four weeks of treatment interruption; histological changes will be also evaluated and     finally, improvement in the overall quality of life as measured by the Short Inflammatory     Bowel Disease Questionnaire (SIBDQ)will be investigated.   "
133508|NCT01537432|"     This study is designed to evaluate the proportion of patients achieving reversal of chronic     plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered     subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive     multiple doses of secukinumab up to week 52 to study long term effects of secukinumab.     Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to     better understand, why secukinumab may be effective in psoriasis patients.   "
133446|NCT01538238|"     Recent advances in understanding the biology and genetics of renal cell carcinoma (RCC) have     led to major therapeutic implications. Von Hippel-Lindau (VHL) gene inactivation, present in     the majority of sporadic forms of RCC, leads to a defective VHL protein, followed by an     active transcription of hypoxia-inducible genes, including vascular endothelial growth factor     (VEGF), platelet-derived growth factor (PDGF), c-kit, and others. However, the concept of VHL     inactivation in RCC and the subsequent malignant phenotype is almost exclusively seen in     patients with clear cell histology.      The data about efficacy of VEGF receptor inhibitors for non-clear cell RCC (NCRCC) is rare     until now. Recently, however, sunitinib and sorafenib showed its worth for NCRCC in extended     access programs.1-3 Although it is not certain, the underlying mechanism of their action     might lie in that papillary, chromophobe, and sarcomatoid type overexpress c-kit, which is     also a target of both drugs and could therefore provide a therapeutic target for non-clear     cell subtypes.4-7 Pazopanib is also a potent and selective, orally available, small molecule     inhibitor of VEGFR-1,-2, and -3, PDGF-α, PDGF-β, and c-kit tyrosine kinases. It has been     validated and licensed for advanced clear cell RCC (CCRCC).8 However, there is very few data     about its efficacy for NCRCC.      In this study, we try to evaluate the efficacy of pazopanib in metastatic NCRCC.   "
133447|NCT01538225|"     Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate     cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with     secondary or primary progressive Multiple Sclerosis (MS).   "
133448|NCT01538212|"     This evaluation of the efficacy and safety of AXONA will be a chart review carried out at 16     practices in which AXONA has been prescribed for the treatment of patients with     mild-to-moderate AD. Efficacy of AXONA will be assessed by comparison of patient status     before and after initiation of treatment.   "
133449|NCT01538199|"     The purpose of this study is to see if using Transcranial LED Therapy (TLT) using the     PhotoMedex's Omnilux NEw-U LED helps improve symptoms of major depressive disorder (MDD). TLT     works by briefly delivering near-infrared (non-visible) radiations to the forehead. The     radiations penetrate the brain and stimulate the cells & metabolism.      Our goals are        -  To assess the antidepressant effect of the TLT in depressed subjects.        -  To assess the safety and tolerability of the TLT in depressed subjects        -  To assess the acceptability of the TLT in depressed subjects        -  To pilot test the impact on cognition of the TLT in depressed subjects (Ancillary Study)   "
133450|NCT01538186|"     This retrospective observational study included patients (pts) with percutaneous coronary     intervention (PCI) of a de novo coronary bifurcation lesion in one German center between     January 2008 - August 2011. The investigators included all consecutive patients where the     side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.      Two different methods were compared: group A represents patients with a simple strategy     without any treatment of the side branch (SB). Group B consisted of patients where the SB was     treated (PCI and/or stenting).      For the treatment of bifurcation lesions we used the concept of provisional stenting,     indications for the treatment of the SB were residual stenosis > 50 %, TIMI flow reduction <     2. Final-kissing PCI was intended in all patients of group B.      MACE during follow-up was evaluated in all patients.   "
133453|NCT01538147|"     Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It     is more prevalent during pregnancy and, if present before pregnancy, can develop an     exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the     physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has     been done trying to link both disorders.   "
133454|NCT01538134|"     The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed     against cell membrane phospholipids (antiphospholipid antibodies) can cause an     hypercoagulable state that causes thrombosis and obstetric complications (miscarriages,     stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis     includes the development of fetal growth restriction (diagnosed postpartum), but this was     done without solid evidence of a relation between the two or using the most common form of     fetal growth restriction diagnosis (ultrasound). Our study will try to add information to     this particular point.   "
133455|NCT01538121|"     The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed     against cell membrane phospholipids (antiphospholipid antibodies) can cause an     hypercoagulable state that causes thrombosis and obstetric complications (miscarriages,     stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis     includes the development of severe preeclampsia before 34 weeks of gestation, but this was     done without solid evidence of a relation between the two. Our study will try to add     information to this particular point.   "
133456|NCT01538108|"     The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's     percutaneous transluminal angioplasty (PTA) Balloon.   "
133457|NCT01538095|"     This phase I trial studies the side effects and best dose of trebananib in treating patients     with solid tumors that has returned after a period of improvement or does not respond to     treatment, including central nervous system tumors. Trebananib may stop the growth of tumor     cells by blocking blood flow to the tumor.   "
133458|NCT01538082|"     The purpose of this study is determine the incidence of metabolic syndrome (MetS) in people     of high risk, of 40 or more years and attended in the Primary Care. Evaluating the     association between anxiety, depression, quality of life and the vital stressful events, and     the development of the metabolic syndrome in general population.      Our hypothesis is that population of the cohort with bigger degree of stress will develop     earlier the metabolic syndrome.      If our hypothesis about the metabolic syndrome are demonstrated, it would allow establishing     in a future interventions on these factors of risk to prevent or to decrease the incidence of     this syndrome in the Primary Care.   "
133509|NCT01537419|"     This study will evaluate the efficacy of attachment based family therapy (ABFT) for treatment     of suicidality in adolescents. The study will compare 16 weeks of treatment with ABFT to a     control condition Family Enhanced Non-directive Supportive Therapy (FE-NST).   "
133543|NCT01536977|"     This pilot clinical trial studies early brief behavioral intervention in treating sleep     disturbance and improving quality of life in patients undergoing bone marrow transplant     (BMT). A brief behavioral intervention may reduce symptoms of insomnia and fatigue and     improve quality of life and cognitive function in patients undergoing BMT   "
133459|NCT01538069|"     Introduction. Heart failure is the result of primary ventricular dysfunction followed by     neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal     and respiratory muscles, which determine their clinical and prognosis. Despite the     advancement in treatment, morbidity and mortality remain high. Physical training appears as a     therapeutic strategy, because most of its beneficial effects is by inducing changes in     peripheral physiological changes resulting from heart failure. Associated factors that may     contribute to its progression and worse prognosis, now beginning to be studied, such as sleep     apnea, the diagnosis provides important prognostic information and a potential therapeutic     option for these patients.      Objectives. Demonstrate the benefits of physical training for patients with heart failure and     sleep apnea, and compare treatment with CPAP alone and associated with the exercise program.     Will also be assessed risk and adherence to physical training.      Material and Methods. The design will be prospective, longitudinal, randomized consecutive     patients. After screening and baseline evaluations the patients will be randomized into Group     1 (CPAP, n = 20), Group 2 (CPAP + Physical training, n = 20), Group 3 (Physical Training, n =     20) and Group 4 (Control without intervention, n = 20). Outcomes (baseline and 3 months):     Quality of sleep (polysomnography), Quality of life (Minnesota and SF-36), sexual function     (QS-M and QS-F) and functional capacity (cardiopulmonary exercise testing and isokinetic     testing). Physical training: aerobic and resistance exercises three times a week for three     months. CPAP therapy:after polysomnography for titration with ventilator servo-assisted, and     outpatient follow monthly, for three months.   "
133460|NCT01538056|"     The primary objectives of this study are to determine whether physician modified endovascular     grafts are a safe and effective method of treating patients with elective, symptomatic or     ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates     for open surgical repair and have no other options for treatment.   "
133461|NCT01538043|"     The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible     mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA).   "
133462|NCT01538030|"     Premature rupture of membranes is an important cause of neonatal morbidity and mortality,     mainly because of the complications associated with this pathology (oligohydramnios, cord     compression or prolapse, infection). When rupture of the membranes occur the risk of cord     compression increases but there is little evidence regarding this complication and amniotic     fluid volume. The investigator's focus are the perinatal outcomes according to amniotic fluid     volume (< 5 or >5).   "
133463|NCT01538017|"     Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's     contracture affecting proximal interphalangeal joints. An open label, medico-independent     randomized controlled trial.   "
133471|NCT01537913|"     Hypothesis: FOUR score is a better predictor of outcome (in hospital mortality and functional     outcome at discharge) than GCS in children 5- 18 years age admitted in pediatric ward/ ICU     with non-traumatic impaired consciousness.      The assessment of comatose patients is an important part of critical care. The assessment of     the level of coma relies on clinical scores. The Glasgow Coma Scale (GCS),remains the most     commonly used scoring system for altered state of consciousness. Despite its widespread use,     a number of limitations have been identified with GCS like inability to assess verbal score     in intubated patients and non-inclusion of vital brainstem functions. The FOUR (Full Outline     of UnResponsiveness) score, a coma scale consisting of four components (eye response, motor     response, brainstem reflexes, and respiration pattern) was recently proposed by investigators     from the Mayo Clinic.keeping in view the limitations of GCS, this study was planned to     compare the new FOUR score with GCS as a predictor of mortality and poor functional outcome     at hospital discharge.   "
133464|NCT01538004|"     The use of automated blood pressure measurement (ABPM) devices in the office setting is     increasingly recognized as superior to manual BP measurement. Current guidelines recommend     that patients be alone in a quiet room, with no interactions with health care professionals     during the readings; in practice, this means using an exam room. However, we found no     evidence supporting the location of ABPM. Furthermore, exam rooms are constantly being used     in primary care offices, so this may not be practical in routine care.      For this study, fifty consecutive consenting patients age 18 or more in each of seven     community based primary care offices will randomly be allocated to either ABPM in an exam     room, or in a non-private area of the clinic. After being tested in the first location they     will then be tested in the second location with the same device. The main outcome will be the     mean value of the last five systolic blood pressures for each location within offices.     Secondary measures will include blood pressures for patients with or without hypertension, a     comparison of the initial and second set of blood pressures and of the effect of office noise     in decibels on BP readings.      New technology is more readily adopted if barriers to use are minimized. If we find no     differences in BP readings between office locations, clinicians will then have the option to     use an additional office area to implement the automated BP measurement device.   "
133465|NCT01537991|"     The I-START trial is designed to determine the highest doses of radiotherapy that can safely     be used in locally advanced non-small cell lung cancer (NSCLC). Patients with NSCLC who are     expected to live longer than three months and are fit to receive radical radiotherapy     (radiotherapy given with curative intent) will be eligible to participate. All trial     participants will receive 20 doses (called fractions) of radiotherapy. Evidence is available     that suggests increasing the dose of radiotherapy given per fraction may improve both local     control of the cancer and survival in some patients. However, high dose radiotherapy can     damage normal tissues as well as the tumour. The dose of radiotherapy that can be used to     treat lung cancer is limited by the normal tissues close to the cancer. For most of these     normal tissues (lung, spinal cord and heart) the maximum safe radiotherapy dose that can be     given is known. The maximum safe dose of radiotherapy for the oesophagus (gullet) is not     currently known.      The trial will be split into two parts:        1. For those participants where the oesophagus will receive a high dose of radiation due to          it lying close to the cancer, the first part of the trial will establish the maximum          safe dose of radiotherapy to the oesophagus. The first group of participants will          receive a slightly higher dose than is currently used to treat lung cancer. If these          participants do not have any significant side effects, a second group of participants          will receive a slightly higher dose than the first group. This process will continue          incrementally until side effects from the treatment become evident, thus demonstrating          the maximum dose that can safely be given. Once the maximum safe dose to the oesophagus          is known this will be classed as the recommended Phase II dose and all further patients          entering the trial will receive no more than this dose to the oesophagus.        2. For those participants where the cancer is a safe distance from their oesophagus, the          highest dose of radiotherapy that does not exceed the known safe dose limits of the          normal structures (lung, spinal cord and heart) will be used.      The findings of both parts of this study will determine whether increasing the dose of     radiotherapy for NSCLC patients is a tolerable, safe and effective treatment. If the results     are positive then this new treatment may be compared against the best currently available     standard treatments in a future larger randomised (Phase III) trial.   "
133466|NCT01537978|"     The purpose of this study is to evaluate whether there are functional improvements in arm     muscles and movments for spinal cord injured indviduals after performing video gaming.   "
133467|NCT01537965|"     The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now     entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest®     and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic     performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study)     for the discrimination of F≤1 versus F≥2, the positive and negative predictive values ,     however, are far from be perfect in a given patient. With these technique, failures are also     possible and the measures do not meet quality standards that increase the risk of     misclassification. It would be particularly useful to have new generation techniques with a     better diagnostic performance.      In this project, in response to the problems presented above, we propose to evaluate the     diagnostic performance of five innovative ultrasonic techniques for the non-invasive     diagnosis of fibrosis.   "
133468|NCT01537952|"     Objective: Microbiologic etiologies of facial palsy in children were investigated.      Study design: Prospective clinical study. Methods: Forty-six children aged 0-16 years with     facial palsy comprised the study group. Paired serum samples and cerebrospinal fluid were     tested to find indications (antibodies, growth of the microbe, or nucleic acids) of microbes     putatively associated with facial palsy. The microbes tested were herpes simplex virus-1 and     -2, varicella-zoster virus, human herpesvirus-6, Mycoplasma pneumoniae, Borrelia burgdorferi,     influenza A and B-, picorna-, cytomegalo-, parainfluenza-, respiratory syncytial-, coxsackie     B5-, adeno-, and enteroviruses, Chlamydia psittaci, and Toxoplasma gondii. Besides the     routine tests in clinical practice, serum and cerebrospinal fluid samples were tested with a     highly sensitive microarray assay for DNA of herpes simplex virus-1 and -2, human     herpesvirus-6A , -6B, -7, Epstein-Barr-, cytomegalo-, and varicella-zoster viruses.   "
133469|NCT01537939|"     ASUKI Step is designed to increase the number of days employees walk 10,000 steps and to     reduce the number of days employees spend being inactive.      Study aims were:        1. to have a minimum of 400 employee participants from each university site reach a level          of 10, 000 steps per day on at least 100 days (3.5 months) during the trial period;        2. to have 70% of the employee participants from each university site maintain two or fewer          inactive days per week, defined as a level of less than 3,000 steps per day;        3. to describe the socio-demographic, psychosocial, environmental and health-related          determinants of success in the intervention; and        4. to evaluate the effects of a pedometer-based walking intervention in a university          setting on changes in self-perceived health and stress level, sleep patterns,          anthropometric measures and fitness.   "
133470|NCT01537926|"     The purpose of the sudy is to conduct a small study to gather the preliminary data for future     lage scale clinical studies that will be designed test the potential beneficial effect of     over-the counter study anti-oxidant drug called N-acetylcysteine (NAC) in patients with a     heart muscle condition called Hypertrophic Cardiomyopathy (HCM). The present study is a pilot     feasibility study, the investigators want to find out whether the investigators can recruit     and retain patients with HCM in the study and whether these patients can tolerate this drug     and can stay on one year. Likewise, the investigators want to find out any potential side     effects that this drug might have and estimate whether ii has any beneficial effects.   "
133472|NCT01537900|"     The goal of this study was to compare hepatic pharmacokinetics (PK) derived from liver tissue     to plasma PK after administration of grazoprevir (MK-5172) to participants with chronic     hepatitis C virus (HCV) infection. Participants will be randomized to one of four different     liver ultrasound-guided Fine Needle Aspirate (FNA) schedules (at 4-, 8-, 24-, or 72-hours     after the Day 7 dose).   "
134910|NCT01518985|"     This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial     enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the     endothelial dysfunction induced by a single cigarette.   "
133473|NCT01537887|"     The purpose of this study is to evaluate the effect on the electrical activity of the heart     as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to     10 days of placebo in relation to a single dose of moxifloxacin. Information about any side     effects that occur will also be collected.   "
133474|NCT01537874|"     This study evaluates the effectiveness of a motivational interviewing intervention with     families with young children ages 0-5 where smoking is happening in the home to adopt a     smoke-free home plan and reduce child's second-hand smoke exposure.   "
133475|NCT01537861|"     Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in patients     with multiple myeloma will generate a 'hostile' bone marrow microenvironment for myeloma     cells, depriving them of key support signals and rendering them more sensitive to     chemotherapy. The investigators therefore propose to do an initial pilot study 1) to explore     the safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment     regimens in patients with bortezomib-, carfilzomib-, or IMID-refractory myeloma and 2) to     generate correlative data for a subsequent larger study looking at the combination.   "
133476|NCT01537848|"     This is a retrospective study of a single center on endoscopic ultrasound (EUS) guided     transmural drainage of post-operative collections during a 9 years period.   "
133477|NCT01537835|"     Healthcare worker uniforms are frequently contaminated with bacteria known to cause     infections in humans. These bacteria are acquired during the workday. A new technology of     antimicrobial textiles have been developed and incorporated into the fabric of health care     worker uniforms, reportedly with effectiveness rates of > 99% but there is little literature     describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial     properties in the clinical setting. Because of the potential benefit that such uniforms could     offer HCWs and patients alike, further investigation into whether these fabrics are effective     is warranted.      Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the general     internal medicine wards will be invited to participate in this study. Participants will be     randomized to wear either uniforms (scrubs) that have antimicrobial properties or standard     scrubs provided by the hospital. At the end of an 8-hour workday, three areas on each uniform     and each subject's wrist area will be cultured to assess for total bacterial colonization as     well as for various resistant bacteria such as methicillin-resistant Staphylococcus aureus     (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative rods.      Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial     contamination than standard uniforms (scrubs) at the end of an 8-hour workday.      Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial     contamination of sites swabbed compared to standard uniform after an 8-hour workday.      Specific aim 1b. Demonstrate that antimicrobial uniforms will have less     antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and     resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour     workday.   "
133609|NCT01536119|"     The purpose of this trial is to evaluate the effectiveness of a Coparenting Breastfeeding     Support Intervention with first time parents on exclusive breastfeeding rates at 12 weeks     postpartum. Partner support and the coparenting relationship will also be evaluated.   "
133478|NCT01537822|"     Rationale:      The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps,     myomas and placental tissue. It withholds some technical advantages over resectoscopy.     Previous data suggest that it's a faster technique than the latter, and shows that it has a     low complication rate.      Objective:      To compare the HM to bipolar resectoscopy for removal of:      1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue,     in terms of efficiency and complications.      Study design: Single blind, randomized controlled multicenter trial.      Study population: Women aged over 18 years old with:      1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual     placental tissue, who are planned for hysteroscopic removal.      Intervention:      Patients are randomized between removal with the HM or the bipolar resectoscope.      Main study parameters/endpoints:      Installation and operating time.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness:      Women who are referred to our polyclinic will be seen on a first visit, and, according to the     standard work-up, an ultrasound will be performed when intrauterine pathology is suspected.     To confirm the diagnosis a saline infusion sonography (SIS) and/or ambulant diagnostic     hysteroscopy will be performed consequently. Once the diagnosis is confirmed and surgery is     planned, women will be asked whether they want to take part in this study. At this moment,     both techniques are used in our hospitals and the choice of treatment depends on the     preference of the gynaecologist. All women will be treated with operative hysteroscopy in a     daycare setting according to the standard of care, only now randomized between the two     techniques. A standard postoperative visit with ultrasound examination and/or ambulant     diagnostic hysteroscopy is scheduled 6 weeks later. Late postoperative complications and     complaints are recorded.      It is expected that the HM beholds some advantages over the bipolar resectoscope such as     shorter operating time and less complications (e.g. risk of perforation, current and fluid     related complications). Previous data do not demonstrate any additional risks related to the     use of the HM. Moreover we will check whether the HM has a lower risk of intrauterine     adhesion formation, as this might influence patient's fertility.   "
133479|NCT01537809|"     The purpose of this research is to determine what supplemental doses of vitamin D may be     necessary to raise serum levels to optimal levels and how vitamin D supplementation and     changes in vitamin D status impact cardiovascular risk factors in schoolchildren.   "
133480|NCT01537796|"     The purpose of this study is to examine the effect of an enhanced technology-based system,     that involves a wearable device to measure calories burned combined with a website, in     comparison to previous versions of similar technology and a standard behavioral weight loss     on body weight across 6 months in obese adults.   "
133481|NCT01537783|"     In this study, the investigators will enroll patients who present to the emergency department     with abscesses to the study. The patients will be randomly selected to either have the     standard of care, which includes the standard drainage of the abscess and then usually a     follow-up visit to recheck the wound, or to have the standard of care plus instructions to     use a topical scrub of a soap called chlorhexidine once a day for five days and twice daily     application of a topical antibiotic ointment called mupirocin to the nasal passages for five     days.      The investigators will then call back the patients at 7 days, 14 days (if in the treatment     arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation. The     study hypothesis is that the patients who have undergone the decontamination protocol will     have fewer subsequent infections.   "
133482|NCT01537770|"     The main purpose of this study:      - to determine whether vertebroplasty has a pain palliating effect superior to a     sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar     spine.      Secondary purposes:        -  To determine if there are differences in the two methods on preventing forward tilting          of the spine and/or shortening of the total height of the spine.        -  measure if there are differences in change of lung capacity between the two methods   "
133483|NCT01537757|"     This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in     participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931 in     participants with severe renal disease and in healthy matched control participants will be     studied. If data from Part 1 confirms that severe renal impairment does not alter the     pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study     will be required and Part 2 will be optional. If the data does not support this conclusion,     then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with     moderate and mild renal impairment compared to healthy matched controls.   "
133484|NCT01537744|"     The purpose of this study is to determine whether 5-azacitidine in combination with     romidepsin cancer are effective in the treatment of advanced solid tumors.   "
133485|NCT01537731|"     Previous studies have shown that chronic pain after hysterectomy is common. The aim of this     study is to investigate the incidence of chronic pain after vaginal or laparoscopic     hysterectomy for benign reasons. The aim of this prospective study is also to study the role     of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.   "
133486|NCT01537718|"     The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized,     longitudinal study.   "
133487|NCT01537705|"     A clinical outcomes study measuring reduction in pain and numbness experienced in four types     of peripheral neuropathy patients during 60 day administration of the an amino acid     formulation.   "
133488|NCT01537692|"     The purpose of this study is to compare the systemic levels of beclomethasone 17     monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP     HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in     healthy volunteers.   "
133489|NCT01537679|"     The purpose of this study is to determine whether meditation will reduce stress and     depressive of adult caregivers of a person with dementia.   "
133490|NCT01537666|"     The study is carried out to evaluate the safety, tolerability and pharmacokinetics of     AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.   "
133491|NCT01537653|"     Primary Objective:      Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous     (SC) doses in healthy Japanese adult male subjects      Secondary Objectives:      Assess the following parameters after ascending single SC doses in healthy Japanese adult     male subjects        -  The pharmacokinetics of SAR231893 (REGN668)        -  The immunogenicity of SAR231893 (REGN668)        -  Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)   "
133492|NCT01537640|"     Primary Objective:      To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668)     drug products after administration of a single subcutaneous (SC) dose      Secondary Objective:      To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug     products after administration of a single SC dose   "
133920|NCT01531959|"     We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready     for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of     stay without increasing MGH length of stay or putting the patient at risk of being readmitted     to an ICU.   "
133493|NCT01537627|"     Several impairing factors contribute to physical limitation in chronic obstructive pulmonary     disease (COPD) as deconditioning, muscle dysfunction and physical inactivity. The available     literature clearly indicates that these therapeutic targets benefit from exercise training in     patients with COPD and, currently, the key point is not whether patients should or not     exercise, but which is the specific contribution of each exercise modality to this     population. About this topic, the characteristics of a physical training program to be     offered to patients have been a point discussed among researchers in this field, although     recently the high-intensity training has been recognized as superior in comparison to the     low-intensity training. Literature also indicates that, in order to change the sedentary     lifestyle of patients with COPD, long-term training programs are indicated. However, a doubt     still remains: if long-term programs are one of the key points to reduce physical inactivity,     it is not yet clear whether it is necessary to include high-intensity exercises in that     long-term program. If the duration is the only factor influencing the outcomes of the     program, thus the intensity of training could be reduced, increasing the adherence of     patients to the protocol. Based on this hypothesis, the aim of this study is to compare the     effects of two physical training protocols in a long-term rehabilitation program (6 months)     in patients with COPD: a high-intensity protocol (based on endurance and resistive training)     and a low-intensity protocol (based on callisthenic and breathing exercises training). It is     expected that the results of this study contribute to the scientific literature by     demonstrating whether low- and high-intensity training contribute equally to change the     sedentary lifestyle of patients after a long-term exercise program.   "
133494|NCT01537614|"     Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI     colimycin either as an aerosol or after IV injection, the administration being separated by 5     to 10 days intervals   "
133495|NCT01537601|"     Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract     infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in     healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not     yet been studied. Through a prospective randomised trial of children with posterior urethral     valves the investigators wish to determine the effect of circumcision on the risk of     presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will     be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both     groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24     months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will     also be monitored. The relative risk of presenting a febrile UTI in each group will be     determined. Clinical, radiological and antenatal data concerning each child will be analysed.     At 24 months follow-up, an impact on family scale survey (IOFS) will be proposed parents.   "
133496|NCT01537588|"     The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and     apply that knowledge to the treatment and management of patients who undergo anterior     cruciate ligament (ACL) reconstruction. There are three main components of this study:        1. How do muscle shape, size, strength, and ability to function change following hamstring          grafting for ACL reconstruction;        2. How does physical activity change following ACL reconstruction;        3. Is there a difference in outcome if graft harvest is done from the injured versus          uninjured limbs   "
133497|NCT01537575|"     Postpolio syndrome is a condition that affects many polio survivors years after the acute     infection and causes symptoms to increase or new symptoms to develop. Proinflammatory     cytokine production within the central nervous system (CNS) indicates an underlying     inflammatory process, amenable to immunomodulatory therapy. In this study the investigators     sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves     the disease.   "
133498|NCT01537562|"     Today a large proportion of early abortions are medical, in accordance to the woman's choice.     The main objective of the present study was to compare, in a randomised fashion, initiation     of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion     with regard to expulsions and safety.   "
133499|NCT01537549|"     Studies have shown that alpha-lipoic acid and L-acetyl carnitine may have some     neuroprotective activities and it is hoped that they could be helpful for people with     neurodegenerative illnesses such as progressive supranuclear palsy (PSP).      The purpose of this study is to find out whether the nutritional supplement alpha-lipoic     acid/L-acetyl carnitine is safe and well-tolerated in individuals with PSP when given daily,     and whether it affects their well-being, brain scan measurements and blood tests that measure     the energy metabolism in cells.   "
133633|NCT01535807|"     The objective of this study is to identify proteomic inflammatory biomarkers to determine if     there are differences in the biomarkers in patients who are treated using the CorMatrix ECM     implant to close the pericardium and the patients whose pericardium is left open (the current     standard of care).   "
133500|NCT01537536|"     The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as     measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of     weekly paclitaxel. This is a prospective single-center study that will investigate the     activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast     cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant     chemotherapy).   "
133501|NCT01537523|"     The early community-care program is well-known rehabiliation for the fracture hip patient.     For the discharged fracture hip patient from hospital, it is worth to investigate the effect     of early mobilization program to improve their physical and psychological aspects.   "
133502|NCT01537510|"     Childhood obesity is highly prevalent and is associated with both short- and long-term     adverse outcomes.      Despite availability of guidelines for nearly a decade and more recent comparative     effectiveness research (CER) evidence, the health care system has been slow to adopt     recommended practices. Although pediatric health care providers often cite barriers such as     limited time, skill, and resources, a frequently overlooked barrier is the lack of data     systems to efficiently and accurately assess guideline implementation and to improve quality     of care for childhood obesity. Health information technology (HIT) offers potential for     accelerating the adoption of CER evidence regarding childhood obesity screening and     management, for establishing treatment benchmarks, and for supporting patients and their     clinical teams in care improvement. Incorporation of HIT may be especially effective if     augmented by outreach to parents and children.      The goal of this study is to develop and test system-level interventions to accelerate the     adoption of CER evidence on childhood obesity screening and management, and ultimately     improve obesity-related health care quality and outcomes. To achieve this goal, the     investigators will work with two health care systems in Massachusetts with strong track     records of research collaboration: Cambridge Health Alliance (CHA), an integrated academic     public health system, and Harvard Vanguard Medical Associates (HVMA), a large multi-site     group practice. Both systems use an electronic medical record for all aspects of ambulatory     care, including point of care services such as electronic order entry and centralized     functions such as patient scheduling.      In these settings of innovation and commitment to improving quality of care, the     investigators will develop and test two systematic strategies for adoption of CER evidence.     The first incorporates computerized point of care decision alerts to pediatric primary care     providers during routine office visits, linked to CER-based algorithms of care. The second     augments this HIT approach with direct-to-parent communication of child's body mass index     (BMI) along with recommended evaluation and management. The specific aims of this study are:        1. In 18 community health centers of CHA, to identify barriers to and facilitators of          adoption of an existing set of computerized point of care decision alerts for childhood          obesity screening and management. The investigators will achieve this aim through          in-depth interviews and surveys with primary care clinicians, which will inform the          design of the investigators proposed intervention.        2. In 14 practices of HVMA, to conduct a cluster-randomized controlled trial to examine the          extent to which computerized point of care decision alerts to pediatric primary care          providers, with or without direct-to-parent communications, will increase adoption of          CER evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th          percentile. The investigators will determine the extent to which each of the 2          intervention conditions, compared with the usual care control condition and with each          other, results in:             1. Increased screening and assessment of childhood obesity at the point of care,               including BMI, blood pressure, and laboratory screening, and provision of nutrition               and physical activity counseling,             2. A smaller age-associated increase in BMI over a 1-year period, and,             3. Improved specific dietary, physical activity, and sedentary behaviors over a 1-year               period.        3. To evaluate each intervention's costs (including clinician and family time) and          cost-effectiveness in terms of children's change in BMI and weight-related behaviors.        4. To develop a detailed dissemination guide to further accelerate adoption of CER evidence          on childhood obesity in practices and communities interested in implementing similar          interventions.      To achieve the investigators aims, the investigators have assembled a research team with     extensive experience in obesity prevention, clinician and child behavior change, clinical     informatics, statistical methodology in cluster randomized controlled trials,     cost-effectiveness analyses, and dissemination science. If successful, this project will     provide new and sustainable approaches for accelerating adoption of CER evidence for     childhood obesity screening and management and for improving quality of care for childhood     obesity in pediatric primary care.   "
133503|NCT01537497|"     The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of     PF-05175157 in a dose-dependent fashion in healthy volunteers   "
133504|NCT01537484|"     The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish     massage for reducing pain and increasing function compared to light-touch bodywork, and usual     care, in 222 adults with OA of the knee.   "
133505|NCT01537471|"     The purpose of the investigators research is to test whether problems people have with     processing their senses (feeling overwhelmed, distracted or upset by sounds and other     stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines,     which are medicines used for things like allergies, sleep problems, or the common cold.   "
133506|NCT01537458|"     Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is     known to cause significant morbidity and mortality, no good guidelines are available to guide     intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral     valve repair. Treatment options for isolated repair have not been investigated thoroughly.      The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve     repair, performed in our center. By doing this, the investigators want to evaluate predictors     of outcome after repair.   "
133510|NCT01537406|"     The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years     after the delivery of the radiation treatment, and to compare the frequency between subjects     that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received     standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast     compared to the non-treated breast, will be assessed. Also, the occurrence of delayed     radiation treatment side effects including tiny red vessels in the skin, breast indurations     (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin     dryness will be captured.   "
133511|NCT01537393|"     The purpose of this study is to determine if the 3-year graft failure rate following     endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14     days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or     fewer days are used.   "
133512|NCT01537380|"     With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a     chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal     complications. The risk of mortality and morbidity are directly proportional to the     importance of overweight and medical treatment alone is only moderately effective weight     loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body     mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection     (SSI). The SSI are the third most common nosocomial infection after urinary tract infections     and airway. The fight against the ISO requires the administration of antibiotic prophylaxis     acting on the main bacteria found in bariatric surgery. There are several studies in the     literature interested in the dose of cefazolin in bariatric surgery. However, no published     pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic concentrations     of cefazolin higher than minimum inhibitory concentrations of the main germs encountered in     these surgery. Only empirical recommendations are published, including the SFAR and the     National Institute of Health in 2010. This study aims to determine whether the dose of 4     grams of cefazolin can achieve these goals of concentration and estimate an injection time of     preoperative ideal for an adequate tissue concentration at the time of the incision.   "
133524|NCT01537224|"     The role of the basal ganglia in the processing of information with emotional or motivational     content has been demonstrated by several lesion and functional imaging studies in humans and     animals. Deep brain stimulation surgery provides an opportunity to study these structures in     humans in electrophysiological terms. The aim of this study is to investigate modifications     in the electrophysiological activity of the subthalamic nucleus (STN) during the perception     of auditory and visual stimuli with emotional or motivational connotations in patients with     Parkinson's disease who have just undergone implantation of a deep brain stimulator in the     STN.   "
133549|NCT01536899|"     The investigators are interested in understanding personal factors such as medical conditions     and mental health, as well as social and economic factors, that influence marijuana (and     other substance) use in HIV-positive patients.      Several alternative hypotheses will be evaluated in the proposed project:        1. healthier patients may self-select marijuana use;        2. marijuana use may be associated with consequences that create barriers to seeking          healthcare;        3. marijuana use may have medicinal value that reduces the need for such care.   "
133550|NCT01536886|"     The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus     betamethasone are effective in the treatment of psoriasis vulgaris.   "
133513|NCT01537367|"     PROJECT OVERVIEW      This research is a collaboration between the Centers for Disease Control and Prevention     (CDC), the Health Resources and Services Administration (HRSA), and six university-affiliated     HIV clinics in the United States.      Study title: Intervention Trials to Retain HIV Patients in Medical Care      Study sites: The study will be performed at six HIV clinics affiliated with academic medical     centers.      Objectives: Using HIV patients' clinical data (without personal identifiers) routinely     archived in electronic databases at the six participating clinics do the following:      • To examine the extent to which a client-centered intervention delivered by trained     interventionists (Phase 2 trial of the project) improves patient attendance for HIV primary     care over and above the effect of the clinic-wide intervention. Phase 2 is a three-arm     randomized controlled trial conducted at each of the participating six clinics. 300 patients     will be enrolled in the Phase 2 trial at each clinic. One hundred will be new patients and     200 will be patients with inconsistent attendance for HIV primary care at the clinic in the     prior 12 months. Patients will be randomized to: (1) an enhanced contact plus behavioral     skills arm or (2) an enhanced contact-only arm in which patients will receive a longer or a     shorter client-centered intervention from two trained interventionists, or (3) the standard     of care arm in which patients will receive the clinic-wide intervention and routine HIV     clinical care only.   "
133514|NCT01537354|"     This is a null hypothesis study. The investigators hypothesize that there will be no     difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute     intervals after administration of either surfactant and there will be no differences in the     number of doses needed between the two surfactants in premature infants admitted to our NICU.   "
133515|NCT01537341|"     Innovative advances in rehabilitation technology have created a split-belt treadmill capable     of providing a much needed intervention aimed at limiting mobility disability. When     desynchronized, the split-belt treadmill imposes demands on each leg such that the central     nervous system must adapt to the challenge. Based on preliminary data from our lab utilizing     the split-belt treadmill, the investigators hypothesize this intervention can challenge the     locomotor processes required for safe, efficient gait while concurrently providing an aerobic     stimulus will produce favorable changes in physical function in older adults at risk for     mobility disability.   "
133516|NCT01537328|"     The purpose of this study is to evaluate the effectiveness of a progressive resistance     rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional     rehabilitation program (TRAD).      The investigators hypothesized:        -  PROG will result in greater improvements in functional outcome measures such as: stair          climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee          Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM).        -  PROG will result in greater improvements in quadriceps muscle strength gains after TKA          compared to TRAD.        -  PROG will result in greater improvements in muscle mass and central activation compared          to TRAD.   "
133517|NCT01537315|"     Presence of multiple traditional and nontraditional risk factors of atherosclerosis and     cardiovascular disease (CVD) including inflammation in patients with chronic kidney disease     (CKD) contribute to high CVD morbidity and mortality in this patient population.     Additionally, the traditional approaches towards the therapy of CVD have little impact on CV     mortality in these patients. Hydroxychloroquine (HCQ) used as anti-inflammatory in     rheumatological disorders, has multiple beneficial properties relevant to the process of     vascular disease. The effects of HCQ on atherosclerosis (AS) and vascular disease in CKD is     not known yet. Thus, the study hypothesis is that HCQ treatment in individuals with CKD will     provide clinically significant benefit in the management of CVD and will provide biological     and functional atherosclerotic benefits.   "
133518|NCT01537302|"     Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted     orientation while simultaneously crossing totally occluded femoropopliteal arteries.   "
133519|NCT01537289|"     A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with     traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.      There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site     pain is less than CT.   "
133520|NCT01537276|"     As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages     including the lack of need for anesthesia, a non-invasive procedure with less cost and     relative easy to put into practice. However, it would be failed to detect the extra-tubal and     peritoneal pathology and would be also difficult to distinguish the obstruction caused by the     spasm of intramural segment. Obviously, imaging quality plays a key role in diagnostic     accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy     were reported a higher sensitivity and specificity than those only taken two images in the     examination. And hybridized radiography with CT or MRI system may provide the good-quality of     the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal     patency in real time, can show pelvic pathologies better than HSG. However, no parallel study     was designed to verify the hypothesis that combined the fluoroscopy and taken more images can     improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the     accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.   "
133521|NCT01537263|"     The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by     ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (SAH).   "
133522|NCT01537250|"     The purpose of this study is to evaluate the safety, tolerability and population     pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.   "
133523|NCT01537237|"     The purpose of this study is to compare rotational angiography (3DATG     technology)intra-procedure (during the ablation procedure) with CT (x-ray) pre-procedure     (before the ablation procedure) fusion to create an anatomical picture of a heart to help     adequately guide an ablation procedure for patients with arrhythmias.   "
133551|NCT01536873|"     ING114916 is an open-label, multi-center, expanded access (EAP) study   "
133552|NCT01536860|"     The purpose of this study is to assess whether added food ingredient(s) affect glycemic     responses to a liquid meal tolerance test (LMTT).   "
133553|NCT01536847|"     The purpose of this study is to assess whether added food ingredient(s) affect glycemic     responses to a liquid meal tolerance test (LMTT).   "
133525|NCT01537211|"     In older adults, poor circulation in the lower extremities leads to serious health     complications including limb loss. In addition, individuals with dysvascular disease also     suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An     individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to     assist with function, including a prosthetic knee and a prosthetic foot. Currently,     dysvascular amputees are given a prosthetic knee based on the basic expectation that they     will be functionally stable. This consideration does not address higher levels of function     like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not     able to counteract their co-morbidities with a more active lifestyle. Walking is less energy     efficient; their traditional prostheses may cause early onset of fatigue and induce a fear of     falling. Newer microprocessor knees enable patients with transfemoral amputations to walk on     different surfaces and at multiple cadences through better control in swing and stance phases     of gait. The impact of the functional differences in the prostheses is not clear and requires     additional investigation to clarify the choice of the most appropriate functional prosthesis.     The purpose of this study is to compare the functional outcomes with the traditional     mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.   "
133526|NCT01537198|"     Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual     practice according to the approved Korean product label will be registered into this     observational study. Baseline data will be obtained at enrollment including demographics,     gestational age, birth weight and underlying diseases and complications especially in regard     to respiratory disease and cardiovascular disease. At routine visits for Synagis     administration, which will occur according to usual medical practice, information on Synagis     prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days     after the last administration of Synagis.   "
133527|NCT01537185|"     The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine     (SPWCV) given with alum is safe and well tolerated by healthy adults.   "
133528|NCT01537172|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-4053     across ascending single and multiple doses in healthy adult male and female subjects.      The secondary objective of the study is to characterize the pharmacokinetic profile of     ONO-4053 in healthy adult male and female subjects.   "
133539|NCT01537029|"     To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in     participants who are normal weight (body mass index [BMI] < 25 kg/m2, overweight or class I     obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that     participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than     participants who weigh less. Restated, the area under the drug-concentration time profile,     also known as the AUC, in participants will decrease as participant weight increases.   "
133529|NCT01537159|"     The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI)     scan of the bone marrow before the start of standard chemotherapy can predict complete     remission of leukemia patients after the therapy. This type of MRI scan, called dynamic     contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow. For those patients who do     not achieve complete remission status after initial therapy and will be treated with     additional therapy, the investigators are also interested in determining if the second MRI     exam before the additional therapy can predict complete remission. If successfully tested,     the MRI exam may be used in the future to help with early identification of patients who are     unlikely to respond to standard chemotherapy. This will allow for a personalized therapeutic     plan to be developed for these patients at an early stage and prevent them from being exposed     to toxic and ineffective therapies.   "
133530|NCT01537146|"     The purpose of this study is to elucidate whether patients operated with high tibia     open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so     that both healing and rehabilitation are served optimally.   "
133531|NCT01537133|"     There are new, very sensitive methods for detecting bacteria. These methods show that     hundreds of millions of microbes (organisms that can only be seen with microscopes),     especially bacteria, live in healthy people. The collection of different microbes found in a     site is called a microbiome. The investigators know that microbiomes of the skin, sinuses,     mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome -     which bacteria are found in a site - may be necessary for good health. For example, the     microbiome of the mouth is different in people with inflammation of the gums (periodontitis),     and the microbiome of the bowel is different in people with inflammation of the intestinal     tract (inflammatory bowel disease).      The purpose of this research study is to find out if the microbiome in the lungs is different     in healthy people without asthma compared to people with asthma. This study will also find     out if the microbiome of the lungs changes when people with asthma take a daily controller     medication called an inhaled corticosteroid.   "
133532|NCT01537120|"     This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool     for the evaluation of both new and existing pharmacological treatments for type 2 diabetes,     using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a     probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin,     twice daily will lead to a statistically significant decrease in 24 hour weighted-mean     glucose (WMG) relative to placebo.   "
133533|NCT01537107|"     This phase I trial studies the side effects and the best dose of sirolimus when given     together with vismodegib in treating patients with solid tumors or pancreatic cancer that is     metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth   "
133534|NCT01537094|"     Obesity is associated with reduced growth hormone (GH) secretion. GH secretion is regulated     by nutritional stimuli including fasting, insulin, glucose and free fatty acids. However, the     role of micronutrients, such as vitamins, on GH secretion has not been investigated in much     detail. Vitamin C levels are also reduced in obesity, and the investigators recently     demonstrated a possible role for dietary vitamin C intake in the regulation of GH secretion     in two preliminary retrospective studies. The investigators therefore propose a more detailed     prospective physiological study to examine the effects of increasing dietary vitamin C intake     on GH secretion in a physiologic, intervention study. The investigators hypothesize that     increasing vitamin C concentrations in obese subjects with sub-optimal plasma vitamin C     levels and reduced GH secretion will increase GH secretion.   "
133535|NCT01537081|"     The study is designed to meet regulatory requirement outside the US. The dosing regimen and     assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not     match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether     Mucinex is effective and non-inferior as compared to placebo and immediate release     guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design     was required based on EU regulatory guidance.   "
133536|NCT01537068|"     The investigators are studying a new antidepressant medicine, desvenlafaxine, for the     treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been     approved by the FDA for the treatment of major depression.      The investigators are testing whether this medicine is also effective for adults with a type     of chronic depression that is less severe than major depression. This condition is also known     as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often     causes significant suffering and impairment.      In addition, the investigators are using MRI imaging, which uses magnetic signals to make     pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in     this study is to see whether chronic depression is associated with differences in brain     structure or functioning, and whether such differences change after medication or placebo     treatment. To test this MRI scans are done at the start of the study and after 12 weeks of     medication or placebo treatment. Getting MRI imaging will be an option for participants in     this study but is not required.      This study involves a 6 to 12 week double-blind period during which half of the participants     will take the new medication and half will take a placebo (an inactive look-alike pill).     After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved     antidepressant medication.      Assessments (of depressive symptoms, social functioning, and personality) will be done by     study staff and by patients before the study starts, at each study visit for the first 12     weeks, and again after 24 weeks in the study.   "
133537|NCT01537055|"     To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple     therapy in the second line therapy for those who fail from one eradication therapy   "
133538|NCT01537042|"     This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in     subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.      The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to     investigate the effect of Rotigotine on quality of life and sleep.   "
133540|NCT01537016|"     The purpose of this trial is to determine if wounds with elevated protease activity (EPA)     treated with targeted interventions such as protease modulating therapies can improve     clinical and economic outcomes.      It is hypothesized that protease modulating dressings may provide significantly better     clinical outcomes on EPA wounds over current standard of care.   "
133544|NCT01536964|"     Heart Attacks are a major cause of death in this country. When patients have a heart attack,     they are treated with anti-clotting drugs, one of which is a drug called Prasugrel. It is     important that Prasugrel starts to work as quickly as possible following a heart attack. As     many patients who have a heart attack experience excruciating pain, they are often given     morphine (a strong painkiller) by the Ambulance crew. We think that morphine may affect how     Prasugrel is absorbed from the stomach and may delay how quickly it starts to work. We intend     to study the effect of morphine on the absorption of Prasugrel.   "
133545|NCT01536951|"     This will be a 2-part, randomized, participant- and investigator-blind study in healthy males     and females.      Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that     yields drug exposures slightly exceeding typical exposures anticipated from repeated     administration of an efficacious dose to participants. The concentration of the drug in the     blood stream will be measured and information about any side effects that may occur will also     be collected.      Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the     heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral     dose.   "
133546|NCT01536938|"     The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone     are effective in the treatment of psoriasis vulgaris.   "
133547|NCT01536925|"     This research deals with behaviors that are part of opioid dependence. The purpose is to     study the extent to which stress and other factors, including money and amount of work     effort, affect opioid choice. Specifically, the investigators will examine the effects of     three issues/factors. The first is how hard participants are willing to work to obtain an     opioid drug; the second is how much opioid drug would participants choose instead of money;     and the third factor is how much participant's opioid drug choices are influenced after they     are administered the drugs yohimbine and hydrocortisone, both of which could produce     stress-like symptoms.   "
133548|NCT01536912|"     More scientific information is needed about medical marijuana use among HIV positive     patients. There is conflicting information about the use of marijuana, use of medical     marijuana, and the associations between them and health status/health risk behaviors/health     care utilization. In addition, it is not clear whether patients who participate in     prospective clinical studies differ from participants who do not participate; if there are     differences between those two groups, then this would limit generalizability of knowledge     about these issues.      The goal of this project is to describe the use of marijuana among HIV positive patients and     its association with health status/health risk behaviors/health care utilization.   "
133554|NCT01536834|"     This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate     the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa     medical device for verrucas in the adult population. The treatment regime will be topical     application of the Verruca treatment to the verruca, identified as the reference, once daily     for 4 weeks.      Patient & investigator derived outcomes will also be collected to assess clinical performance     and adverse events and adverse device effects will be reported to assess safety profile.      Patient assessments will take place pre-treatment to determine patient demography, baseline     clinical status, pain and verruca size prior to treatment. Compliance with treatment schedule     will be collected via patient diary cards. Furthermore, patients will be assessed on day 2     after starting treatment and then again at 7, 14, 21 & 28 days after starting treatment.     Diary cards will completed through-out the investigation.   "
133555|NCT01536821|"     The PROGENI Family Study is part of a larger consortium that is studying a gene shown to be     important in Parkinson's disease, called LRRK2. People who have a defect in the LRRK2 gene     will often develop Parkinson's disease. Eligible participants will be asked to complete a     single Study Visit at an affiliated research facility closest to their home.   "
133556|NCT01536808|"     The potential clinical implications of this study are to optimise the selection of a     population at risk for developing a diabetic cardiomyopathy among diabetic patients in order     to develop early therapeutic strategies to prevent the left ventricular remodelling.      Therefore, the originality of this project is to hypothesize that :        -  Diabetes mellitus is often associated with a premature aging syndrome        -  Cellular senescence may potentiate the mechanisms that are involved in decreasing          myocardial contractility in DM and,        -  DM associated to premature aging may increase the risk of developing a cardiomyopathy          Thus, the modulation of telomerase activity and the control of telomere length, together          with the attenuation of the formation of reactive oxygen species, might represent          important new targets in order to develop therapeutic tools in prevention of diabetic          cardiomyopathy.   "
133557|NCT01536795|"     This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing)     is more effective than WR279396 without occlusion for once daily treatment.      Extensive objective and subjective local tolerance data will also be captured during this     trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the     deep dermis) that may help to determine the optimal number and duration of treatments.      The results from this study will help determine the most practical treatment schedule and     will answer questions that are crucial to improve the present treatment regimen with WR279396     which is twice a day for 20 days.   "
133558|NCT01536782|"     The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or     pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated     calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck     undergoing chemoradiation therapy.   "
133610|NCT01536106|"     The primary objective of the study is to determine the feasibility and safety of     intracoronary administration of autologous bone marrow derived mononuclear cell product in     patients at risk for clinically significant cardiac dysfunction following AMI.      The secondary objective of the study is to assess the effect on cardiac function and infarct     region perfusion. A concurrent placebo control patient group meeting eligibility but not     receiving autologous bone marrow derived stem cells will be evaluated similar to the treated     group to assess the rate of significant spontaneous improvement in cardiac function.   "
134050|NCT01530243|"     The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin     and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.   "
133559|NCT01536769|"     The cause of Parkinson's disease (PD) is unknown and a reliable biomarker to identify PD     patients as early as possible is urgently needed. Nerve cells near the nose and in the gut     become first affected in PD and patients frequently suffer from loss of smell and     constipation. The nose and gut harbor very high amounts of bacteria that influence our body     functions in many ways, even in the brain. The investigators are examining a possible role of     bacteria of the nose and gut in the pathogenesis of PD. This may lead to a better     understanding of what PD causes and may open new possibilities for diagnosis and treatment.      The investigators will recruit 100 PD patients and 100 control subjects. The investigators     will characterize all subjects carefully with respect to clinical symptoms. The investigators     will collect bacterial samples from the nose, mouth and stool of these subjects. Using modern     genomic techniques the investigators will read out the genetic code of all bacteria contained     in these samples and will be able to identify which species of bacteria are present in the     samples. Using complex cluster computing the investigators will compare the pattern of     bacterial species between PD patients and controls and look for specific abnormalities in PD     patients.      If the investigators can detect specific differences of bacterial communities between PD     patients and controls this may point to a role of bacteria as a cause of PD. Since there are     many ways to influence bacterial communities pharmacologically (antibiotics, probiotics) it     will be possible to investigate whether these therapies could alleviate or even reverse PD     symptoms. Furthermore, the investigators would be able to use these differences as a     biomarker which would enable us to develop a quick screening test for bacterial samples that     may reveal whether a person has PD or not.      By doing this study the investigators will learn whether bacteria play a role in the     development of PD and whether the investigators can use them as a biomarker or therapeutic     target. So hopefully the investigators will be able in the future to better understand what     causes PD, how the investigators can diagnose it as early as possible and how to cure     patients from PD.   "
133560|NCT01536756|"     Evidence shows that depression was found to be associated with physical inactivity and on the     other hand, high prevalence of depression was also found in patients with chronic pain.     Structured physical rehabilitation program with exercises as main component and pain     management provided by physiotherapy has been proved by overseas studies to be effective in     reducing the psychological symptoms of depression through increasing the physical fitness and     relieving the pain. Literatures also reported a strong sociocultural influence on the     prevalence of depression and the manifestations of their clinical signs and symptoms in     patients suffered from mental health problems between Chinese and Western societies. The     benefits of physical rehabilitation program in the management of depression cannot be assumed     in the Chinese population. The purpose of this study is to investigate the effectiveness of a     structured Physical Rehabilitation Program for Chinese patients diagnosed with depressive     disorder (mild to severe severity) on the physical fitness and negative psychological     symptoms of the recruited patients.      The Hypothesis are:        1. The Physical Rehabilitation Program is effective in improving the physical fitness in          Chinese patients with depressive disorders.        2. The Physical Rehabilitation Program is effective in alleviating the negative          psychological symptoms in Chinese patients with depressive disorders.   "
133561|NCT01536743|"     The purpose of this study is to obtain an estimate of the biochemical response rate as     determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria     of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is     defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial     evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).   "
133598|NCT01536262|"     The primary objective of this study is to assess the safety of 52 weeks once daily treatment     with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT     Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).   "
133599|NCT01536249|"     This study will assess the effect of cimetidine on the pharmacokinetics (PK) of     dexpramipexole in healthy volunteer and evaluate the safety and tolerability of     dexpramipexole when given with or without cimetidine. Additionally, this study will explore     the influence of genetic variation on the PK of dexpramipexole when given with or without     cimetidine.   "
133562|NCT01536730|"     The Centers for Disease Control and Prevention has declared that AIDS is a state of     emergency in the US for African Americans - young African American men are especially     vulnerable in this epidemic. Thus, the development of effective interventions tailored to     this population is a national priority. The investigators previous preliminary studies     suggest that a brief, clinic-initiated, home-based, self-guided condom use program may     effectively promote the acceptance of condom use and increase the quality and consistency of     condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility     of this program (Homework Intervention Strategy, HIS) for young African American men     attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the     program. The HIS has the potential to be readily translated into widespread practice, while     requiring only minimal resources. Unlike previously tested interventions, the HIS can be     applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI     status. To develop the HIS to meet the needs of these high-risk men, the proposed study will     include a formative phase during which the basic intervention instructions which will be     delivered by DVD will be refined and tailored for this population.      One hundred young African American men recruited from an urban STD clinic will be randomized     to each of two groups (HIS vs. standard of care) in a randomized 2-arm trial with 5     assessment periods over the course of 6 months. Assessments will compare the groups on     frequency of unprotected sex, quality of the condom use experience, experience of condom use     errors and problems, attitudes regarding condom use, condom use acceptability, and condom use     self-efficacy and confidence.   "
133563|NCT01536717|"     The purpose of this study is to examine the wound infusion of articaine for treatment of     acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized     design and an active control (bupivacaine)   "
133564|NCT01536704|"     To compare the bio equivalence of new nicotine lozenge formulation with the reference     nicotine lozenge so as to deliver the same nicotine blood profile.   "
133565|NCT01536691|"     The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and     Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing     of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):      Prospective multicenter, randomized, single blinded, phase III study.   "
133636|NCT01535768|"     After implantation of an Ahmed glaucoma valve in patients with glaucoma, hyperencapsulation     phase is an unwanted postoperative phenomenon, typically occurring with the free 3 months     postoperatively. When this does occur, it is treated with aqueous suppressant eye drops.      This study aims to determine if it is possible to reduce the rate of hyperencapsulation     phase. Patients in the treatment group will receive aqueous suppressant eye drops before the     hyperencapsulation phase starts. Treatment will be initiated once their intraocular pressure     is above a pre-defined level, and will target a pre-defined range.   "
133637|NCT01535755|"     The investigators use a protocol to wean from noninvasive mechanical ventilation.   "
133566|NCT01536678|"     GSK markets a drug called levothyroxine or T4 that is used to treat patients with     hypothyroidism. Till date, the active drug substance or active pharmaceutical ingredient     (API) for levothyroxine tablets marketed in India has been obtained from a particular source.     GSK India proposes to change the source of the API from the existing source to a new source.     Some patients may experience a change in clinical effect when switched from one formulation     to another. Therefore this study is being done to understand whether a change in API in     levothyroxine tablet has any impact on the clinical effect of the drug.      The purpose of this study is to:      See how quickly the levothyroxine tablet from the new source (single dose of 600mcg) enters     the bloodstream, is distributed in the body, broken down and removed compared to the     levothyroxine tablet from the existing source (single dose of 600mcg).      Study the effect of single 600mcg doses of levothyroxine tablet from new source and     levothyroxine tablet from existing source on TSH level in the blood.      Study the safety and side effects of single 600mcg doses of levothyroxine tablet from new     source and levothyroxine tablet from existing source.   "
133567|NCT01536665|"     This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide     adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects     with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment     with liraglutide or placebo.      Subjects will initially be randomised to one of the three dose groups, and subsequently     randomly allocated to one of two treatment sequences (liraglutide/placebo or     placebo/liraglutide).   "
133568|NCT01536652|"     This study is conducted in Europe. The aim of this observational study is to document the     glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic     episodes, in patients that switched from insulin glargine combined with oral antidiabetic     drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.   "
133569|NCT01536639|"     This study is conducted in Europe. The aim of the study was to evaluate the safety and     efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix     insulin analogue treatment compared to previous insulin regimen in routine clinical practice     in the Slovak Republic.   "
133570|NCT01536626|"     This study is conducted in Europe. The aim of this observational study is to observe and     investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic     insulin aspart 30/70 (BIAsp 30) in an outpatient setting.   "
133571|NCT01536613|"     This study is conducted in Asia. The aim of this study is to review the safety and efficacy     of biphasic insulin aspart 30 in post-marketing use.   "
133572|NCT01536600|"     This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate     biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic     agent (OHA) for type 2 diabetes management in routine clinical practice.   "
133573|NCT01536587|"     This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects     with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive     Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with     salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32     subjects is planned to be enrolled.   "
133574|NCT01536574|"     This open label extension study allows assessment of the long term safety profile of REQUIP     PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.      Subjects must not have a break in study medication between completing the feeder study and     entering extension study, treatment must be continuous.      Subjects will be dispensed down-titration medication at the study completion/early withdrawal     visit and should be scheduled to return for a follow up visit 4 to 14 days after the last     dose of study medication.   "
133600|NCT01536236|"     To obtain preliminary estimates of the safety and efficacy of the ANS Eon™ Implantable Pulse     Generator with ANS leads in the treatment of subjects with diabetic polyneuropathy.   "
134911|NCT01518972|"     The purpose of this study is to determine whether the drug prazosin is effective for the     treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).   "
133575|NCT01536561|"     Phase I/II, single-center, dose-escalation study of the safety, pharmacokinetics, dosimetry,     and efficacy of TST/I-131 TST for the treatment of patients with chemotherapy-refractory or     resistant low-grade, intermediate-grade, or high-grade B-cell lymphoma. Subjects received 1     to 3 dosimetric doses followed by a therapeutic dose of TST/I-131 TST. Study BEX104526 was a     follow-up study of the long-term safety and efficacy data from the surviving patients who     completed at least 2 years of follow-up following administration of TST/I 131 TST on Study     BEX104728.      Dosimetric dose: Subjects received 1 to 3 dosimetric doses of TST/I-131 TST, followed by a     therapeutic dose of TST/I-131 TST. Subjects received various doses of unlabeled TST (0, 95 or     475 mg) to determine the dose of unlabeled TST that optimized the radiation dose delivered to     the tumor by TST/I-131 TST. The unlabeled TST was followed by 5 milliCurie (mCi) of I-131     TST. Serial whole body sodium iodide scintillation probe counts were obtained daily, for at     least 5 days, in order to determine the rate of whole body clearance of radioactivity     (residence time). The residence time was used to determine the radioactive clearance for the     subject and the activity (in mCi) of I-131 required to deliver the desired TBD of radiation     during the therapeutic dose. Because 475 mg was determined to be the optimal pre-dose of TST     in the first subjects entered, the last 34 subjects received a single dosimetric dose that     was preceded by an infusion of 475 mg of TST.      Therapeutic dose: Groups of 3-6 subjects were enrolled at successively higher whole-body     radiation dose levels beginning at a total body dose (TBD) of 25 centiGray (cGy). The TBD of     each subsequent dose level was escalated by 10 cGy. Subjects who had undergone bone marrow     transplantation (BMT) underwent a separate dose escalation (10 cGy TBD increase per dose     level) beginning at a TBD level of 65 cGy. The MTD was defined as the highest dose level at     which 0/3 or 1/6 subjects experienced dose-limiting toxicity (DLT). DLT was defined as     follows:      Any Grade 4 hematologic toxicity (National Cancer Institute [NCI] criteria) lasting greater     than 7 days, or Any Grade 3 hematologic toxicity lasting greater than 2 weeks, or Any Grade 3     or 4 nonhematologic toxicity Redosing. Subjects who achieved tumor regression were considered     for re-dosing, using the original therapeutic dose of TST/I-131 TST, at the time the tumor     was no longer shrinking in an attempt to upgrade their response.      Retreatment. Subjects who achieved partial (PR) or complete response (CR) were considered for     retreatment following relapse of their NHL, if progression occurred ≥6 weeks following the     therapeutic dose. The original therapeutic dose of TST/I-131 TST was given unless a grade 2     or greater toxicity had been encountered, in which case a reduced dose was administered for     the repeat therapeutic dose.   "
133576|NCT01536548|"     Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a     button-hole technique is increasingly recommended. By using the same two sites for     cannulation there are reports of less risk of complications and less pain for the patient.     However, button-hole cannulation can be difficult for the dialysis nurse, and failing     cannulations can damage the AV fistula and increase patient discomfort. The investigators     therefore will test whether a simple marking on the skin of the direction and angle of     cannulation used in each specific patient could improve the probability of a successful and     painfree cannulation.   "
133638|NCT01535742|"     The purpose of this study is to determine whether there is a clinically relevant difference     in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate     through the Ambu Aura-i or air-Q ILA.   "
133577|NCT01536535|"     This is a multi-center, open-label study to determine the safety and effectiveness (how well     it works) of two standardized treatments called mesalamine (Pentasa®) and prednisone in     children with newly diagnosed UC. Standardized treatments are types of treatments agreed upon     and used by many qualified doctors. The medications being used in this study are considered     standard of care. Currently the ways in which these medicines are used (doses, frequency of     dosing) may vary from site to site. This study will determine response to a standardized way     of giving these medicines.      This study will also identify biomarkers for ulcerative colitis. Biomarkers are things that     doctors can find in blood, stool, or bowel tissue that indicate how much inflammation there     is in the bowel, how the inflammation is produced, and whether the inflammation is responding     to treatment. Collecting response and remission (free of symptoms) information on these     standardized treatments and the biomarkers can possibly help doctors create a model, or     plan to know which children with UC may respond quickly, or which children may develop     complications.   "
133578|NCT01536522|"     The overall goal of the Asthma Inflammation Research [AIR] Translational Program is to create     an integrated multidisciplinary team for the focused purpose of development of diagnostic and     prognostic tests informative for airway inflammation, and for the design of innovative,     targeted biologic therapeutics.      The overarching aims of the AIR program are to conceptualize, develop, and test the     next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will     allow us to improve the standard of asthma care.   "
133579|NCT01536509|"     The purpose of the study is to test an online behavioral intervention to improve medication     adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be     monitored for four weeks to determine how frequently their child's IBD medication is taken.     Patient's taking less than 90% of medications will be randomized to one of two intervention     conditions to complete intervention sessions online. The study consists of 4 online     intervention sessions with topics differing by condition and 5 online assessments to complete     quality of life questionnaires over a 14 month time frame.   "
133580|NCT01536496|"     The purpose of this study is to compare rapid thrombelastography (r-TEG) with conventional     coagulation testing for diagnosing and treating coagulation abnormalities in severely injured     patients who are likely to require transfusion therapy.   "
133581|NCT01536483|"     Clinical management of very low birth weight newborns (VLBW <1250g) consists in several     challenges to adapt immature physiological systems to extrauterine life. Advances in neonatal     medicine for pulmonary and/or neurological and/or cardiovascular diseases have significantly     improved outcomes of these children. However, the gastro-intestinal (GI) tract remains a     major cause of morbidity due to        1. the immaturity of GI functions (prolonged ileus, bacterial overgrowth and          translocation),        2. the complication of GI tract immaturity: intestinal perforation and enterocolitis          necrotizing)        3. the need of a prolonged parenteral nutrition and its complications (central venous          catheter infections, sepsis, electrolyte disturbances) but without generate a high proof          level on this targeted population (<1250g).      The GI functions are progressively acquired during development and are largely sensitive to     the environment, especially the intestinal luminal content. Indeed, probiotics and prebiotics     have shown beneficial effects upon GI functions of newborns. One of the metabolite of the gut     flora potentially involved is the butyrate. Butyrate is a short chain fatty acid produced in     the colon by the microbiota (carbo-hydrates degradation). The colonic amount of butyrate     increases gradually after birth. The beneficial effects of butyrate are related to its     properties upon the epithelial barrier (anti-inflammatory, antioxidant, barrier repair) and     upon the enteric nervous system (network of neurons and glial cells) that regulate GI     functions and in particular colonic motility.      To date, there is no clinical consensus to manage digestive disorders of VLBW. Several     clinical studies have assessed the effects of prokinetic drugs, dietary supplements     (probiotics, prebiotics) but without generate a high proof level on this targeted population.     In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant 004) has shown     benefit effects of oral probiotics supplementation in children with birth weight greater than     1000g but not in extreme preterms with birth weight less than 1000g.      The main hypothesis to explain theses results lies in the intensive use of antibiotic and     feeding interruption frequency in this targeted population which induce disturbances in the     composition of the gut lumen (in particular the flora).      Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate     a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic     mechanisms.      Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a     prospective randomized clinical trial blinded design.      The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the     nutritional management of extreme preterm less than 1250 grams, by facilitating the     development of colic motility and clinical nutrition tolerance.   "
133582|NCT01536470|"     The purpose of this study is to evaluate whether a preventive strategy of intraoperative     arterial hypotension using noradrenaline can reduce the incidence of postoperative organ     failure.   "
133583|NCT01536457|"     There have been a number of studies which attribute causality between reflux disease and     asthma. In addition, clinicians typically treat chronic asthmatics with high dose acid     suppressing medications (e.g. lansoprazole). However, clinical trials only recently have shed     some light on this dilemma, with recent studies suggesting that the association is not as     clear. This retrospective analysis of a prospective study which treated mod-severe     asthmatics with lansoprazole or placebo will enter the collected raw data into a database,     then perform statistical analyses to determine if children with asthma treated with acid     suppression improved their asthma compared to those receiving placebo.   "
133584|NCT01536444|"     This case series will assess the use of suction blister epidermal grafts harvested by a novel     device on select patients that have wounds from Mohs or excisional surgery.   "
133585|NCT01536431|"     The purpose of this study is to address the safety issue of whether, in patients with     newly−diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely     affects the rate of damage to the insulin making cells.   "
133601|NCT01536223|"     Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive     either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF)     neoadjuvant chemotherapy with concurrent chemoradiation.   "
133602|NCT01536210|"     This study will evaluate clinical efficacy and safety of treatment with YY-162 in children     with ADHD.   "
133603|NCT01536197|"     The investigators wish to study the effects of two forms of bariatric surgery, gastric bypass     and lap banding. The surgery is not part of the clinical trial. If your insurance does not     cover the procedure, then the patient is responsible for payment of the surgical process. The     investigators are doing pre and post surgery testing to provide a better understanding of the     effect of bariatric surgery-induced weight-loss on taste perception.   "
133586|NCT01536418|"     This is a multi-centre, randomised, double-blind, active treatment, parallel group induction     study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive     one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for     12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease     Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI     score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to     qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary     objectives will include assessment of the safety and evaluation of the efficacy in induction     of clinical response or remission. Safety will be assessed by recording of adverse events and     assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram.     Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes     assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D,     and Work Productivity and Activity Impairment-Crohn's Disease.   "
133587|NCT01536405|"     This study will compare the safety, tolerability, and immunogenicity of measles, mumps,     rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with     those of the 2006 process   "
133588|NCT01536392|"     The goal of this clinical research study is to compare granisetron (when given through a     patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with     cervical, endometrial, or vaginal cancer having chemoradiation.      Granisetron and ondansetron are designed to help reduce nausea and vomiting.   "
133639|NCT01535729|"     This prospective observational study will evaluate the efficacy and safety of Tarceva     (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after     failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in     routine clinical practice will be collected for 1 year.   "
133589|NCT01536379|"     Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes     a transplanted kidney is rejected by the patient's immune system. Many types of immune system     cells, including B cells, are active in rejection. B cells produce antibodies against     anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that     help prevent transplant rejection affect cells other than B cells. Belimumab is a medication     used to treat a disease called lupus. Belimumab slows development of antibody-producing B     cells. This study will test whether belimumab works on parts of the immune system that cause     rejection. Twenty to thirty adults getting a kidney transplant will be in this study. Like     flipping a coin, a computer will randomly assign half to be given belimumab and half to be     given placebo (a fake medicine). Patients and doctors will not know which medicine was     assigned until the study is over. A total of 7 doses of study medicine will be given through     a vein. One dose will be given during transplant surgery, and the other 6 will be given 2, 4,     8, 12, 16 and 20 weeks after transplant surgery. Usual transplant medicines will also be     given. After all of the doses have been given, patients will be watched and tested at 24, 36,     and 52 weeks after the transplant surgery. Blood samples will be tested to see what study     medicines do to the immune system in transplant patients. If patients get a kidney biopsy,     the samples will be tested to see if belimumab had any effect. Patients will be asked many     questions to see if they are having any side effects. The study will be done at Addenbrooke's     Hospital in Cambridge and Guys &St Thomas Hospital in London, United Kingdom. A     pharmaceutical company, GlaxoSmithKline, is funding the study.   "
133590|NCT01536366|"     The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.   "
133591|NCT01536353|"     The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in     healthy male volunteers.   "
133592|NCT01536340|"     The purpose of this study is to:      -Determine the incidence of adverse events, preventable adverse events, and ameliorable     adverse events, and the timeliness of post-discharge ambulatory appointments, affecting urban     and rural patients approximately 3-4 weeks after discharge from a hospitalist-run medical     service of a large community hospital to home.      H1: The incidence of post-discharge adverse events will be higher in rural patients compared     with urban patients discharged from a hospitalist-run medical service of a large community     hospital.      -Identify and classify the types of post-discharge adverse events (e.g., adverse drug events,     procedure-related events, hospital acquired (nosocomial) infections, falls, and other)     affecting urban and rural patients approximately 3-4 weeks after discharge from a     hospitalist-run medical service of a large community hospital to home.      H2: All patients will be at higher risk for adverse drug events than other types of adverse     events.      -Examine the relationships between the population at risk, characteristics of the health care     delivery system, and the utilization of post-discharge health services, and how these     relationships help us understand the incidence of post-discharge adverse events.      H3: Several factors will be independently associated with the incidence of post-discharge     adverse events in rural and urban patients, including patient comorbidity, severity of acute     illness, presence of a primary care physician prior to hospitalization, and a scheduled     timely post-discharge ambulatory follow-up appointment.   "
133593|NCT01536327|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of     metachromatic leukodystrophy disease from plasma. Testing for clinical robustness,     specificity and long-term stability of the biomarker.   "
133594|NCT01536314|"     The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2     weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared     to placebo group.   "
133595|NCT01536301|"     The main objective is to demonstrate that postoperative analgesia by IV oxycodone (compared     to morphine IV) reduces opioid-related adverse events (nausea, vomiting, pruritus,     respiratory depression, urinary retention, allergies, hallucination) by 50% in adult patients     operated on for prosthetic hip surgery.   "
133596|NCT01536288|"     Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance     physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat     fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are     widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by     human study. The investigators conducted a randomized, double blind, placebo controlled,     crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.   "
133597|NCT01536275|"     In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the     first week in critically ill children is beneficial, compared to the current standard of the     early start of parenteral nutrition.   "
133604|NCT01536184|"     Study Summary: This study is being conducted in order to rigorously evaluate the real-world     effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of     Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes     in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk     for FASD, as delivered under routine practice conditions.      Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list     control group receiving standard services, the treatment group receiving COS will show     greater improvement in caregiver behaviour, as well as child emotional and behavioural     outcomes.   "
133605|NCT01536171|"     This experimental study will compare impact forces and metabolic cost in runners (N=20; ages     18-45 years, who already use a forefoot strike running gait) in two treadmill running test     sessions (shod vs barefoot running)   "
133606|NCT01536158|"     The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better     or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.   "
133607|NCT01536145|"     This study represents the first-in-human study for CP-751,871. The study aimed to define the     safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple     myeloma through a dose escalation design.   "
133608|NCT01536132|"     The purpose of this study is to determine the safety and efficacy of intravenous     administration of intermittent doses of levosimendan (infusions of 0,2 μg/kg/min, of     levosimendan or placebo, without bolus, for 6 hours every 2 weeks) compared to placebo in     ambulatory patients with advanced chronic heart failure.   "
133611|NCT01536093|"     Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory     protection against nosocomial infection in extremely premature infants. However, most of them     could not proceed enteral feedings due to clinical instability in the first few days. Recent     studies supports oropharyngeal administration as a potentially safe and effective delivery     method for immunologic benefits and only small amount of colostrum could be administrated for     immune therapy for extremely premature babies. The purpose of this study is to determine the     beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in     extremely low gestational age infants and evaluated the safety of this method to extremely     premature infants in the first few days of life.   "
133612|NCT01536080|"     Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final     diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even     functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal     symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the     measurement of GERD symptoms and response of proton pump inhibitor in short time. Several     questionnaires have been made for the assessment of GERD symptoms in recent years However,     their screening tools do not include the impact of symptoms on everyday life and take a long     time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been     developed to compensate for this. It is a simple, one-page, questionnaire to communicate to     the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing     that it might also prompt clinicians to make appropriate treatment for patients' symptoms.     However, there was no report regarding comparison of the characteristics and response to PPI     in RE, NERD and FH groups using GIS questionnaire so far.   "
133613|NCT01536067|"     This phase II trial studies how well giving ofatumumab together with bortezomib works in     treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal     antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways.     Some block the ability of cancer cells to grow and spread. Others find cancer cells and help     kill them or carry cancer-killing substances to them. Giving ofatumumab together with     bortezomib may be a better way to block cancer growth   "
133614|NCT01536054|"     This phase I trial studies the side effects and best dose and schedule of sirolimus when     given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial,     fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Vaccines made from a     gene-modified virus may help the body build an effective immune response to kill tumor cells.     Giving vaccine therapy together with sirolimus may be an effective treatment for ovarian,     fallopian tube, or primary peritoneal cancer   "
133615|NCT01536041|"     The primary objectives of this study are:      i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on     exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced     expiratory volume in 1 second (FEV1) after exercise challenge      ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg     of ONO-6950 in asthmatic patients.      The secondary objectives of this study are:      i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus     montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise     challenge      ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg)     single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.   "
133616|NCT01536028|"     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics     and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin     aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.   "
133617|NCT01536015|"     The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor     symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis:     Rotigotine will decrease OFF time compared to Placebo.   "
133618|NCT01536002|"     The objectives of this study are        -  To determine PK of propofol in bariatric patients        -  To identify the physiological variables that induce propofol PK changes in bariatric          patients, when compared to a normal-weight population.        -  To define context-sensitive half-time profiles for propofol in bariatric patients.   "
133619|NCT01535989|"     This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted     intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin,     in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in     patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both     Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in     combination with rituximab in patients with NHLs. This is the first study combining the two     agents together. In the present study Inotuzumab Ozogamicin will be administered     intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered     intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated     every 28 days.   "
133620|NCT01535976|"     Procedures performed under sedation have the same severity in regards to morbidity and     mortality as procedures performed under general anesthesia1. The demand for anesthesia care     outside the operating room has increased tremendously and it poses, according to a closed     claim analysis, major risks to patients . Both closed claim analysis identified respiratory     depression due to oversedation as the main risk to patients undergoing procedures under     sedation. The major problem is that hypoventilation is only detected at very late stages in     patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation,     hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.      The incidence of anesthetized patients with obstructive sleep apnea has increased     substantially over the last years along with the current national obesity epidemic. These     patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The     context of the massive increase in procedural sedation and the extremely high prevalence of     obstructive sleep apnea poses major respiratory risks to patients and it may, in a near     future, increase malpractice claims to anesthesiologists. The development of safer anesthesia     regimen for sedation are, therefore, needed. The establishment of safer anesthetics regimen     for sedation is in direct relationship with the anesthesia patient safety foundation     priorities. It addresses peri-anesthetic safety problems for healthy patient's. It can also     be broadly applicable and easily implemented into daily clinical care.      Ketamine has an established effect on analgesia but the effects of ketamine on ventilation     have not been clearly defined. The lack of validated and sensitive instruments to evaluate     the effects of ketamine on ventilation is an important reason for the conflicting results.The     investigators have demonstrated that the transcutaneous carbon dioxide monitor is accurate in     detecting hypoventilation in patients undergoing deep sedation. Animal data suggest that when     added to propofol in a sedation regimen, ketamine decreased hypoventilation when compared to     propofol alone. It is unknown if ketamine added to a commonly used sedative agent (propofol)     can decrease the incidence and severity of hypoventilation in patients undergoing deep     sedation. It is also unknown if the effect of ketamine on ventilation are different in     patients with and without obstructive sleep apnea.      The investigators hypothesized that patients receiving ketamine and propofol will develop     less intraoperative hypoventilation than patients receiving propofol alone. The investigators     also hypothesized that this effect will be even greater in patients with obstructive sleep     apnea than patients without obstructive sleep apnea.      Significance: Respiratory depression due to oversedation was identified twice as the major     factor responsible for claims related to anesthesia. The high prevalence of obstructive sleep     apnea combined with more complex procedures done in outpatient settings can increase physical     risks to patients and liability cases to anesthesiologists. The main goal of this project is     to establish the effect of ketamine in preventing respiratory depression to patients     undergoing procedures under sedation. If the investigators confirm the their hypothesis ,     their findings can be valuable not only to anesthesiologist but also to other specialties (     Emergency medicine, gastroenterologists, cardiologists, radiologists) that frequently     performed procedural sedation. The research questions is;does ketamine prevent     hypoventilation during deep sedation? The hypotheses is; ketamine will prevent     hypoventilation during sedation cases.   "
133621|NCT01535963|"     The primary objective of this study is to measure the overall level of satisfaction in     patients after cutaneous surgery in 4 different categories, including the surgeon, facility,     procedure and recovery and outcome.   "
133622|NCT01535950|"     This study will assess the safety and efficacy of LFG316 in patients with age related macular     degeneration.   "
133623|NCT01535937|"     This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time     to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent     individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week     combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.   "
133624|NCT01535924|"     This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride     when given together with gemcitabine hydrochloride and to see how well it works in treating     patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as     gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving     more than one drug, combination chemotherapy, may kill more cancer cells.   "
133625|NCT01535911|"     This study will look at the effects, good and/or bad, of treating primary brain cancers with     diet therapy using an energy restricted ketogenic diet (ERKD) that uses food. An energy     restricted ketogenic diet is a diet designed to keep blood sugars in the low range of normal     while at the same time increasing the blood concentration of metabolic break down products     called ketones. This diet is currently used to treat children with uncontrollable seizures.     This diet is well tolerated by the children with minimal side effects reported after using     the diet for years.        -  The main purpose of this study is to find out whether or not the energy restricted          ketogenic diet will help patients with primary brain cancer by either decreasing the          size of the cancer or by keeping the cancer from growing.        -  Another reason for doing this study is to learn about the side effects associated with          the energy restricted ketogenic diet in patients with primary brain cancer.   "
133626|NCT01535898|"     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the     body using magnetic field and radio frequency pulses that can not be felt. The purpose of     this study is to determine if a new MR imaging method can help tumor evaluation in head and     neck cancer or prostate cancer. The extra images will be obtained using Diffusion-weighted     Magnetic Resonance Imaging which provides image contrast through detection of small     restrictions in the movement of water molecules. This study may help us provide additional     information about the tumor along with the picture of the organ.   "
133627|NCT01535885|"     This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus     Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a     related family member or an unrelated donor. Recipients of these types of transplants are     severely immune compromised during the early post-transplant period and are more susceptible     to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T     Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus     (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or     other infusion related toxicities.   "
133628|NCT01535872|"     The aim of this study is to show solid evidences of the efficacy of DHEA in improving the     success rates of in-vitro fertilization (IVF) patients facing poor ovarian reserve.   "
133629|NCT01535859|"     The purpose of this study is to determine whether cabergoline is effective in reducing the     incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe     cases; and to derive biomarkers for the risk of developing OHSS.   "
133630|NCT01535846|"     Energy-restricted diets often require dieting rules, which forced the dieter to eat according     to cognitive norms, which increase his vulnerability to external food cues. Allowing the     recognition of internal hunger and satiety cues by using conscious food tasting could be     helpful among restrained eaters to facilitate an internalized regulation of food intake.      The objectives of the proposed study are to investigate among restrained women whether     conscious food tasting can influence 1) attitudes and behaviors associated with food and     eating; 2) reliance on hunger and satiety signals; and 3) development of taste and olfactory     memory.      Females (n=50) will be randomly assigned to: 1) experimental group (conscious food tasting     intervention) (n=24), or 2) control group (n=26). The conscious food tasting intervention     will be conducted by a registered dietitian into groups of ten to twelve women during six     weekly 2-hour workshops. Women in the control group will not receive any intervention.     Measurements will be taken at baseline, at the end of the intervention period, and at 12-week     post-intervention. Restraint Scale, Three-Factor Eating Questionnaire, Mindful Eating     Questionnaire, Intuitive Eating Scale, Body-Esteem Scale and Rosenberg Self-Esteem Scale will     measure attitudes and behaviors associated with food and eating as well as some aspects     related to psychological functioning. The Intuitive Eating Scale and a snack-meal taste     rating task (visual analogue scales) will assess internal hunger/satiety cues. Vocabulary     used to describe the foods will be recorded from the snack-meal taste rating task and use to     assess taste and olfactory memory. Sensory capabilities will be assessed by odour detection     and identification test, and a taste detection test.      The proposed study will provide a better understanding of the effects of conscious food     tasting on eating attitudes and behaviors, which is relevant to dietetic practice as it could     help to promote sustainable healthy eating habits.   "
133631|NCT01535833|"     The investigators scientific aims are to determine the benefits associated with the use of     robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how     the benefits impact the patient, physician and the institution, and to determine the     complications associated with the use of the robot. This will be a prospective cohort     following 100 patients for a 24 month period.   "
133634|NCT01535794|"     The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26.     Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could     benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little     is known about factors associated with vaccine acceptance in this population. With the risk     of anal cancer among MSM higher than the risk of cervical cancer among women before routine     cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup     is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal     cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many     acceptable concepts among these men, there are multiple barriers which may potentially     interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates     among women of a similar age has been poor, and there is no reason to expect this to be     higher among men. One potential strategy to increase vaccine uptake in this catch-up group is     to implement a patient-driven program to promote vaccination among men.      This project will contribute to the investigators understanding of how the investigators can     utilize social networks to identify barriers to HPV vaccination among YMSM, and how to     potentially influence a patient-driven vaccination effort to increase uptake among men in the     catch-up age group. This research will inform future interventions to targeted populations     that may be incorporated into online social networking websites to encourage HPV vaccination.   "
133635|NCT01535781|"     The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with     pertrochanteric hip fractures.      Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to     investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss     in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip     fracture.      An interim analysis was planned when reaching 60 inclusions. The interim analysis was     conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was     considered a reason to halt the study. The 0.001 level was chosen as a simple approach to     this interim analysis from the Haybittle-Peto boundary   "
133733|NCT01534468|"     H7N7 is one type of influenza virus that may pose a threat to humans if an outbreak occurs.     This study will evaluate the safety and immune response to an H7N7 vaccine in people who have     previously received a live attenuated influenza vaccine (LAIV) as part of a research study     and people who have not previously received a LAIV.   "
133640|NCT01535716|"     Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical     care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic     optimizations are more efficient when based on the dynamic parameters than when based on the     statics ones, and the major dynamic criteria is the cardiac output. Unfortunately,     transpulmonary thermodilution, the device considered as The gold standard to evaluate     cardiac output is associated with many complications.Furthermore, devices commercialized in     the past decade were not able to replace the transpulmonary thermodilution.      As all monitoring devices aren't reliable enough to be widely used in practice they are left     aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on     the analysis of several clinical parameters seems to guarantee good cares thanks to a     favorable benefits/risks balance, it could be improved by new plug and play mini-invasive     systems.      In the investigators opinion, the ECOM system seems able to provide a monitoring tool which     responds to all the expectations of a modern hemodynamic monitoring device. It uses a well     known technique, the bioimpedance. The investigators suppose this device should be more     efficient than the one that has been used before. Indeed, as the system is build on the     endotracheal tube, it comes closer to the aorta, where all the measures are made, and the     recorded signal should be less affected by the passage through the surrounding tissues.      This randomized and controlled trial will study Patients scheduled for elective coronary     surgery with cardiopulmonary bypass.      The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed     hemodynamic therapy based on the ECOM cardiac output measure on mortality and major     postoperative cardiac morbidity after coronary surgery, when compared with a standard     management strategy.      Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard     management strategy, applied to the control group, will be set and led by the attending     anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face     the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke     volume variation.      The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure     will reduce mortality and morbidity after cardiac surgery.   "
133641|NCT01535703|"     Monitoring could secure management for patient but stay invasive. The purpose of this study     was to compare,after cardiac surgery, the cardiac output measurement between transpulmonary     thermodilution(reference method) and digital photoplethysmography (non invasive) for absolute     value and dynamics changes before and after fluid expansion for patients with indication of     fluid challenge.   "
133642|NCT01535690|"     Background: Photodynamic therapy (PDT) is a method of microbial reduction which can benefit     periodontal treatment in areas of difficult access, such as deep pockets and furcations. The     aim of this randomized controlled clinical trial was to evaluate the effects of PDT as an     adjunct to full-mouth ultrasonic debridement in the treatment of severe chronic     periodontitis.      Methods: Twenty-two patients with at least one pocket with probing depth (PD) ≥ 7 mm and one     pocket with PD ≥ 5 mm and bleeding on probing (BOP) on each side of the mouth were included,     characterizing a split mouth design. The control group underwent full-mouth ultrasonic     debridement and test group received the same treatment associated with PDT. The following     clinical parameters were evaluated: plaque index, gingival index, BOP, gingival recession     (GR), PD, and clinical attachment level (CAL). All parameters were collected before, 1, 3 and     6 months after treatment.   "
133643|NCT01535677|"     This is an open-label, randomised study to compare the similarity of a combination     Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and     fed conditions in healthy volunteers.   "
133644|NCT01535664|"     The purpose of this study is to determine changes on overall gait as well as in multiple gait     and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are     receiving the medication consistently for at least two weeks prior to screening.   "
133646|NCT01535638|"     The primary objective of the current study is to investigate the relative bioavailability of     three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation     (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and     administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy     volunteers, with the aim to compare the bioavailability of the three formulations. All     treatments will be applied fed, 30 minutes after start of the intake of a standard normal     breakfast.   "
133647|NCT01535625|"     This study evaluates the safety and effectiveness of the Momo Cobalt Chromium stent system     for the treatment of single de novo lesions in a native coronary artery. The stent is coated     with diamond-like carbon to decrease the risk of acute and late stent thrombosis, to increase     the resistance towards corrosion and to significantly improve endothelialisation through the     inhibition of elution of metallic ions.   "
133648|NCT01535612|"     The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes     (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch     on insulin delivery device) to control his/her blood glucose.   "
133649|NCT01535599|"     The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic     Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the     treatment of acute otitis externa (AOE).   "
133650|NCT01535586|"     Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder     (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in     patients with PTSD compared to those without PTSD and contribute to worsening cognitive and     behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment     of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general     population. The proposed study aims at comparing the efficacy, tolerability, and adherence of     mandibular advancing devices-an alternative therapy to OSA- to CPAP. The study is     instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA     phenotype that would predict MAD response.   "
133651|NCT01535573|"     This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine     dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent     patients will be assigned equally to one of three medication conditions: placebo or the     Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or     40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase     periods of sustained abstinence substantially more than placebo. Performance on a set of     behavioral tasks of impulsivity will be analyzed as potential predictors of treatment     response.   "
133652|NCT01535560|"     The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle     based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa     (AOE).   "
133653|NCT01535547|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics (PK) of tacrolimus after single dose administration.   "
133654|NCT01535534|"     During the past years many investigators have focused on the immunological changes in sepsis     disease, and great attention has been paid to the development of practicable means of     immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during     the time course of patients with sepsis.   "
133655|NCT01535521|"     The investigators will perform a clinical trial comparing mandibular advancement device (MAD)     therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients     with positional sleep apnea using MAD. Patients are invited for 2 consecutive     polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD.     PSGs are performed at the Antwerp University Hospital.   "
133656|NCT01535508|"     Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation,     titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in     vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.      The study will determine if initial safety and effect estimates predict that a double blind     randomized control trial (RCT) with a larger set of patients will be worthwhile in the     localization of this treatment aimed at improving the symptoms of ASDs.      Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core     symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior,     and sleep, as determined by parental and clinical evaluation scales.   "
133657|NCT01535495|"     This study is investigating if the oral beta antagonist propranolol can induce regression of     retinal neovascularization associated with proliferative diabetic retinopathy.   "
133658|NCT01535482|"     The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT)     with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of     suicide ideation (SI) and the severity of depression and hopelessness among older men. The     investigators expect that suicidal older men randomly assigned to the CT intervention     condition will have a lower rate of SI during the follow-up period than participants assigned     to the control condition.   "
133659|NCT01535469|"     This will be a stepped wedge randomized trial design to evaluate the implementation of     cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected     persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are     ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow     assay. Those who are CRAG-positive and asymptomatic will be treated with high dose     fluconazole. After 6 months survival with retention-in-care will be compared between those     who are CRAG+ and CRAG negative   "
133660|NCT01535456|"     The main purpose of this study is to see if this tracer can be used to determine how well     chemotherapy is working in patients with certain types of leukemia.   "
133661|NCT01535443|"     Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in     healthy volunteers.   "
133673|NCT01535287|"     The investigators are inviting your child to participate in this research study because your     child is having myringotomy (putting a tiny incision in the eardrum with or without tube     insertion) under general anesthesia.      The purpose of this study is to determine whether a single injection of Dexmedetomidine     (study medication) decreases the frequency of awaking from anesthesia frightened or agitated     in children having myringotomy surgery as compared to those children who receive placebo     (sterile saltwater).   "
133662|NCT01535430|"     Purpose of the study:      AIM 1 Prospectively collect pre-operative (fMRI, DTI, MEG) and intra-operative mapping data     in patients with intra-axial brain tumors to assess how well each modality predicts the     location of eloquent brain function. In addition, each modality will be compared with the     other.      AIM 2 Assess reorganization of eloquent brain function and plasticity in patients with     intra-axial brain tumors. This will be accomplished by prospectively collecting     post-operative mapping studies and neuropsychological tests to compare them to prior mapping     studies as stated above.   "
133663|NCT01535417|"     The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new     herbal anti-arthritic agent, in patients with osteoarthritis of the knee.   "
133664|NCT01535404|"     The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection     fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the     left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular     systolic function (>= 45%).   "
133666|NCT01535378|"     If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and     more important. Treatment of patients presenting TMD is based on conservative and reversible     therapeutics. The behavioural reeducation of these patients which aims at decreasing their     parafunctions is a treatment often performed.   "
133667|NCT01535365|"     Muscle sprains of the back and neck are very common. In addition to pain and antiinflammatory     medications the use of either cold or hot packs has been recommended. In the current study we     will compare ice packs and heat packs to see which is more effective at relieving pain from     back and neck sprains while in the Emergency Department.   "
133668|NCT01535352|"     Low income mothers of young children represent a disadvantaged group who are at exceptional     risk for depressive syndromes and who have increasingly limited access to mental health     services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated     cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with     Depression Course, and tailored to mothers of young children. Mom-Net, which was developed     and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to     overcome the substantial barriers to treatment participation that exist for mothers     experiencing economic hardship and those in rural communities. Though the pilot trial     demonstrated that the program was very effective in reducing depressive symptoms and related     difficulties, it was conducted under the 'idealized' conditions typical of initial     intervention tests (e.g., computers and internet connections were supplied to all     participants; access to the internet was provided by a single browser; coaches who provided     weekly phone support were research staff, and initial recruitment and motivational interviews     sessions were conducted via home visits to participants). These conditions likely facilitated     recruitment and retention of participants, as well as ease and fidelity of treatment     delivery. Thus one goal of the current project is to evaluate the intervention under     conditions that are closer to those of real-world service providers and recipients. The     current project is also intended to provide a more rigorous test of the intervention than did     the pilot in a number of ways. Participants in the pilot trial will be 300 mothers of 3-5     year old children recruited through Head Start classrooms and prescreened for the presence of     elevated depressive symptoms.Subsequent to the pre-intervention assessment, participants will     be randomized to either the intervention or facilitated usual care (FUC) condition. The     evaluation of the intervention will focus on maternal depressive symptoms, parenting     behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month     intervals) will enable us to examine maintenance of effects. Overall, the investigation will     contribute to the evidentiary base regarding the dissemination potential of this     empirically-supported intervention, adaptations to which have the potential to enable a     greater proportion of the population to access and benefit from it.   "
133944|NCT01531647|"     This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug     interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers.     Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days,     danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days     18-21.   "
133669|NCT01535339|"     Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport.     Despite ongoing research, there is no highly sensitive clinical test for cognitive function.     This makes the clinical diagnosis of concussion particularly difficult as the clinical     presentation of concussion is highly variable with symptoms often evolving over time. Given     the variability in concussion presentations, there is no single test that can diagnose a     concussion. Current recommendations are that sports medicine providers apply a multifaceted     concussion assessment battery that combines subjective symptoms, motor control and cognitive     assessment.      This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in     detecting and managing concussive injuries. This study will establish the reliability of BNA™     scores over clinically relevant assessment intervals and investigate the effect of SRC and     sub-concussive head impacts on BNA scores.   "
133670|NCT01535326|"     In minimally sedated Asian patients in a community setting the investigators showed that a     limited volume of water infusion instead of air insufflation in either the rectal sigmoid     colon or the whole colon significantly reduced pain score during colonoscopy. Cecal     intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in     our previous studies.1, 2 In contrast, several US reports described the successful use larger     volumes of water infused throughout the entire colon in patients undergoing colonoscopy which     result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review     suggested that the cause of the difference might lies in the timing of water removal.6     Specifically, the investigators group removed the infused water predominantly during     withdrawal phase (water immersion) and the U.S. group removed water during insertion phase     (water exchange).      This prospective, randomized controlled trial compared water exchange or water immersion with     traditional air insufflation in patients undergoing minimally sedated colonoscopy. The     investigators test the hypothesis that water exchange can reduce more pain than water     immersion in the investigators clinical setting.   "
133671|NCT01535313|"     Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness     is improved with a powered bone marrow biopsy device in comparison with a manual device.   "
133672|NCT01535300|"     The aim of the present study was to evaluate the role of ultrasound in paediatric patients to     compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse     tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by different     age-related formulas.      The investigators hypothesize that a prediction of pediatric ETT is possible with the     ultrasonographic measurement of the MTTD.   "
133684|NCT01535144|"     The purpose of the study is to show the equivalence of a new degradable metallic device to a     non-degradable metallic device in patients with Hallux Valgus.   "
133674|NCT01535274|"     The seated or beach chair position during surgery and general anesthesia decreases brain     oxygen levels and can result in stroke. As such, poor neurological outcome following beach     chair positioning is a growing concern. In the proposed study the investigators test the     hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral     oxygenation in anesthetized patients in the beach chair position.   "
133675|NCT01535261|"     The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using     as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema     secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical     coherence tomography (OCT) images was analyzed to gain insights into predictive factors for     disease progression and the possibility of reduced monitoring was assessed in Year 2. The     results of this open-label study provided long-term safety and efficacy data to further guide     recommendations on the use of ranibizumab in this indication.   "
133676|NCT01535248|"     Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize     and evaluate the pancreatic and biliary systems. It has been reported that rare instances of     air embolus have been found associated with the performance of an ERCP and many of these     events are fatal. It is our proposal to use transthoracic echocardiography to continuously     evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and     attempt to quantify the incidence of this complication and any potential patient factors that     might increase the risk of this complication.   "
133677|NCT01535235|"     The investigators propose a proof-of-concept, pathogenesis-oriented, randomized,     placebo-controlled pilot study to assess whether the addition of an angiotensin converting     enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses     lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune     responses and an accelerated clearance of the latent reservoir.   "
133678|NCT01535222|"     The purpose of this study is to demonstrate that periprocedural infusion of escalating doses     of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to     characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of     MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and to     investigate the effect on exploratory clinical endpoints of bleeding, transfusion     requirements and reexploration.   "
133679|NCT01535209|"     Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is     considered as a standard associated with side effects leading to decreased neurocognitive     function. The Investigators addressed the question whether stereotactic radiotherapy of the     resection cavity impairs neurological status and/or cognitive functions in compare to     adjuvant WBRT.   "
133680|NCT01535196|"     The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution     improve the heart function in chronic heart failure.      Type of study: Controlled, randomized, double blind, placebo control      Number of patient: 300; 150 treated and 150 placebo controlled      Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month      Duration of study:1+1 year      Primary end points:      Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,      Secondary end points:      Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in     6 minutes      Visits:      Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,   "
134051|NCT01530230|"     The investigators examined whether there was a difference in the occurrence of ST depressions     after injection of five or ten units of oxytocin, in preeclamptic patients delivered by     caesarean section (CS) under regional anesthesia.   "
133681|NCT01535183|"     The outcome of pediatric refractory or relapsed brain tumor is very dismal. Standard     chemotherapy showed poor response to these patients. Although tandem high dose chemotherapy     with hematopoietic progenitor stem cell rescues has been chosen as a potentially curative     therapy for long term survival and better outcome is expected if tumor burden before     transplantation reduced by chemotherapy, effective salvage chemotherapy for tumor reduction     is not established yet. Irinotecan is a recently developed topoisomerase I inhibitor, and     there are preclinical and phase I, II data which proved practical effects in brain tumors. In     those studies, irinotecan was administered alone or in combination with one other drug.      Vincristine, etoposide, carboplatin, and cyclophosphamide have been used in many protocols     for brain tumors but the result was very poor in refractory or relapsed cases. However,     irinotecan can be effective with these multiple chemotherapeutic agents. According to the     pilot study of irinotecan in combination with vincristine, etoposide, carboplatin and     cyclophosphamide in the investigators center, 75% percent of total 12 patients reached more     than stable disease, and 2 patients got long term complete remission only with this     multi-agent combination chemotherapy. But the combination of irinotecan, vincristine,     etoposide, carboplatin, and cyclophosphamide is not clinically studied yet especially for     pediatric patients. To improve response rate and progression-free survival, the combination     chemotherapy of irinotecan, vincristine, etoposide, carboplatin, and cyclophosphamide is     designed for pediatric refractory or relapsed brain tumor.   "
133682|NCT01535170|"     Nosocomial infection with antibiotic-resistant strains is a major threat to critical care     medicine. Selective decontamination of the digestive tract (SDD) is one of the strategies to     reduce ventilator associated pneumonia and sepsis in critically ill patients. Lactoferrin     (LF) is a natural multifunctional protein with antimicrobial, anti-tumor, antioxidant, and     immunomodulatory effects. It has been shown to inhibit the growth of a number of pathogenic     bacteria including antibiotic-resistant strains, fungi and even viruses in both in vitro and     in vivo studies.      In a recent study, the investigators performed pathogen challenges of the digestive tract of     a transgenic milk-fed animal model. The results showed that recombinant LF has broad spectrum     antimicrobial activity in the digestive tract and protects the mucosa of the small intestine     from injury, implying that LF can be used as an effective selective decontaminant of the     digestive tract.      This study is a prospective, randomized, double-blind, placebo- controlled clinical trial     examining whether oral supplementation with bLF can reduce nosocomial infection, sepsis and     even mortality in patients with prolonged mechanical ventilation (MV). Patients with MV for     more than 21 days and no signs of infection on admission to our Respiratory Care Center (RCC)     will be enrolled. They will be randomized to receive either bovine LF (bLF, 10 mg/kg/day) or     placebo for 6 weeks by center.      The primary objective is to evaluate the effectiveness of bLF in the prevention of nosocomial     infection. Secondary objectives are assessment of incidence of nosocomial infection,     mortality, weaning rate from MV and change of the immune system. The investigators     hypothesize that bLF may 1) prevent nosocomial infection; 2) reduce mortality; 3)increase     weaning rate from MV; 4)increase immunity in patients with prolonged MV.   "
133683|NCT01535157|"     The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus     ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In     addition, researchers would like to determine if the drugs are most effective together or if     fenretinide (4-HPR/LXS) is most effective alone.   "
133687|NCT01535105|"     Obesity is increasing all over the world in adults, adolescents and children,and is followed     by morbidity, including the metabolic syndrome.      Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis      The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18     years, among high risk diabetes prone population, for diagnosis and treatment.   "
133688|NCT01535092|"     Orthotopic liver transplantation (OLT) is the treatment of choice for patients with Hepatitis     C Virus (HCV) infection and end-stage liver disease or hepatocellular carcinoma; infection of     the graft and hepatitis C recurrence is universal after OLT and recurrent HCV hepatitis often     follows an accelerated course after OLT, with rapid histological recurrence and cirrhosis.     These very poor outcome significantly affect graft and patient survival and reduces the     benefit of transplantation for this indication. Therapeutic strategies are not available;     high viral load, high prevalence of genotype 1b and need of dose reduction of interferon and     ribavirin because of the side effects or intolerance, together with the interference of     immunosuppressive drugs, resulted in the vast majority of the patients in failure in     obtaining viral eradication.      Recently, Silibinin, has been studied and reported to be capable to act as potent antiviral     agent in patients with HCV; it has been used successfully in a protocol of a 14 day     intravenous infusion in previous non-responders to peginterferon/ribavirin therapy. In view     of his postulated profile of safety, it seems an ideal drug to be used in the setting of HCV     recurrent patients after liver transplant.      Aim of this prospective, randomized, double-blind, placebo-controlled, parallel group study     is to determine the therapeutic effect of Legalon SIL in the prevention of HCV reinfection in     chronically infected hepatitis C patients after OLT.      Awaiting orthotopic liver transplantation patients affected by HCV will be randomised 3:1 to     receive, in addition to their current therapy, silibinin 20mg/kg/day (Legalon SIL) or placebo     infused over 2 hours from 14 to 21 consecutive days; in addition, patients will receive     treatment with silibinin 20mg/kg/day (Legalon SIL), infused over 2 hours, for 7 days after     transplant.      The Primary Efficacy endpoint is to achieve sustained virological response (SVR) while     Secondary Efficacy endpoints are to evaluate the virologic response, the percentage of     patients who has a decreased of at least 2 log10 the levels of HCV-RNA and the safety of     Legalon SIL in this population.   "
133689|NCT01535079|"     Sore throat is one of the most common complaints encountered in clinical practice. And in     65% of cases, the infection is thought to be viral in nature.      The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after     single administration in acute sore throat pain.   "
133690|NCT01535066|"     RATIONALE: Acupuncture may help relieve joint pain.      PURPOSE: This randomized phase III trial studies acupuncture to see how well it works     compared to sham acupuncture or waitlist in treating patients with joint pain related to     aromatase inhibitors in patients with early-stage breast cancer.   "
133691|NCT01535053|"     This randomized phase III trial studies how well methotrexate works compared to dactinomycin     in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in     chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. It is not yet known whether methotrexate is more effective than     dactinomycin in treating gestational trophoblastic disease.   "
133692|NCT01535040|"     RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms of     nicotine withdrawal.      PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride     works compared to placebo in helping cancer survivors stop smoking.   "
133693|NCT01535027|"     Increased bone formation in the absence of accelerated resorption is resulting in a marked     anabolic response to teriparatide (TPTD) during the early phase after treatment initiation.     Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing     anabolic effects are accompanied by significantly increased bone resorption as well.     Antiresorptives influence the balance of bone formation and resorption. Therefore the     investigators aim is to investigate the effects of the addition of antiresorptives to the     second half of TPTD cycle when resorption is already also markedly elevated.   "
133694|NCT01535014|"     The purpose of this study is:        -  To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in          treatment of obese patients.        -  To assess clinical efficiency of Dietressa in the dose of 6 tablets daily within 24          weeks of therapy in reducing body weight in obese patients.        -  To compare clinical efficiency of two dosage patterns for Dietressa (1 tablet 6 times          daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.   "
133695|NCT01535001|"     The purpose of this study is to test whether an algorithm for systematic non-surgical     treatment consisting of corrective insoles, neuromuscular training, weight loss, patient     education and pharmacological treatment with paracetamol, non steroidal anti inflammatory     drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of     life than standard non-surgical treatment (information on the disease and how to treat it) in     patients with knee osteoarthritis.      The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of     life and functional capacity and greater reduction in pain than standard treatment at the     primary endpoint, which is follow-up 12months after the start of the treatment.      See statistical analysis plan available under Links for further description of the study.   "
133696|NCT01534975|"     The purpose of this study is to compare the effects of a certain contrast agent (iodixanol)     to two other commonly used contrast agents called Iopamidol (Isovue) and iohexol (Omnipaque),     on heart and kidney safety in patients undergoing a cardiac CT angiogram. The investigators     will evaluate whether iodixanol 320 (Visipaque®), an iso-osmolar agent, is better tolerated     (flushing, injection site pain/warmth, headache, nausea) and provides equal image quality     compared with iohexol 350 (Omnipaque®) and Isovue 370 during 64-slice multidetector computed     tomography angiography (MDCTA). A fourth group (Visipaque 270) will be included, using low     radiation dose technology during acquisition, to evaluate image quality, tolerability, and     contrast enhancement compared to both Visipaque 320 and Omnipaque and Isovue. In addition to     image quality, tolerability, and contrast enhancement, the investigators will evaluate heart     rate, adverse events, reimaging, costs, and patient satisfaction among all four cohorts.      The study will recruit 400 participants already undergoing CT angiography and consent and     randomize them to one of four groups. Each of the possible contrast agents used are commonly     used for CT angiography, so the primary risk is loss of confidentiality and being asked     questions about tolerability. All other facets of the study (3 lead ECG, beta blockade,     nitroglycerine use, CT angiography and contrast administration) are standard of care and     being done for clinical uses.   "
133747|NCT01534286|"     The purpose of this study will be to show the patient response to analgesics taken post     surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The     data collected will be used to show that patients have a shorter and lower post operative     pain measurement and the time to discontinuation of analgesics is less in the active     comparator group.   "
133697|NCT01534962|"     Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low,     intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful     electrical cardioversion in patients with persistent atrial fibrillation (AFib).      After successful cardioversion and subsequent randomisation, patients report trans-telephonic     EGCs on a daily basis to a central core ECG facility.      Maximum treatment duration is 112 days (16 weeks).   "
133698|NCT01534949|"     This study is designed to provide initial evidence of safety, pharmacokinetics,     pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.   "
133699|NCT01534936|"     This is a noninterventional observational study lead amongst psychiatrists, to assess the the     overall status of schizophrenic outpatients with affective symptoms treated with atypical     antipsychotics.   "
133700|NCT01534923|"     The purpose of this study is to learn more about doctor-patient communication about colon     cancer screening. This study will also look to see if there are differences in those who get     colon cancer screening based on the discussion the doctor had with the patient.   "
133701|NCT01534910|"     The investigators will be assessing the effect of Aged Garlic Extract on the coronary     arteries. The investigators will enroll patients in a double blind study, where half the     patients will receive placebo, and have the patients undergo a series of tests of plaque (CT     scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and     then repeat the tests and blood work at the end of one year. The investigators will assess if     being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The     investigators will also assess the effect of aged garlic extract on markers of inflammation.     Patients will receive free drug, free testing and be compensated, and learn more about their     heart and neck arteries. if successful, more patients can use this drug to benefit their     health. The harms include the radiation from the CT scan and the medication, which has mild     side effects.   "
133702|NCT01534897|"     Radioactive iodine therapy is often part of the standard treatment for Papillary Thyroid     Carcinoma (PTC) patients. However, in many patients, tumors develop a resistance or no longer     respond to radioactive iodine therapy (iodine-refractory). Several lines of evidence suggest     that blocking the BRAF gene may help to re-sensitize the tumors to radioactive iodine. BRAF     is a protein that plays a central role in the growth and survival of cancer cells in some     types of PTC. The investigational drug GSK2118436 may work by blocking the BRAF protein in     cancer cells lines and tumors that have a mutated BRAF gene.      In this research study, the investigators are looking to see if GSK2118436 can re-sensitize     iodine-refractory PTC to radioactive iodine therapy. The investigators are also looking at     the safety of adding GSK2118436 to radioactive iodine therapy.   "
133703|NCT01534884|"     This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective,     Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last     and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA     concomitantly treated with MTX during the Core Study Period.   "
133827|NCT01533220|"     The common cold is a major cause of nasal obstruction and reaches children and adults twice     or more times a year. At the moment, there is no cure for the common cold, and therefore the     reduction of symptoms is the focus of treatment.      The study was designed to parallel distribution, with two equal groups, with one group will     receive treatment with a combination of naphazoline hydrocloride + pheniramine maleate +     panthenol and the other will receive treatment with naphazoline hydrocloride.   "
133704|NCT01534871|"     Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects approximately 1% of     all Canadians. RA is associated with a higher rate of disease and death as well as a     decreased life expectancy. Changes in death rates and life expectancy are mainly the result     of an increased frequency of cardiovascular disease (CVD). The increase in CVD frequency is     primarily attributable to accelerated atherosclerosis. It is believed that elevated levels of     inflammation, which are characteristic of RA, play a key role in accelerated rate of CVD in     RA patients. Thus, inflammation is considered a primary risk factor for CVD in RA patients.     Interestingly, despite a better understanding of the relationship between RA and CVD and     improved treatment for RA patients the death rate in RA population continues to increase.     Thus, there is an immediate need to develop treatment strategies to reduce the risk of CVD     associated with inflammation in the RA population.      Exercise is commonly used to reduce the risk of CVD. Preventative exercise programs are often     offered as part of cardiac rehabilitation (CR) programs. These programs help patients modify     CVD risk factors, improve physical capacity and decrease CVD risk. Studies also suggest that     CR programs decrease levels of inflammation. Since RA patients have an elevated risk for CVD,     which is primarily attributed to increased levels of inflammation, they are prime candidates     for CR programs. However, RA patients are very rarely referred to CR programs. Thus, there is     a lack of information regarding the effects of CR on RA patients. Thus studies are needed to     determine whether CR modifies levels of inflammation and decreases CVD risk in RA patients.     Therefore, the purpose of this study is to determine the effects of a 12-week standardized     cardiac rehabilitation exercise program on systemic inflammation and CVD risk in individuals     with RA. Specifically, this study will characterize the effects of a community based CR     exercise program on systemic markers of inflammation (proinflammatory cytokines) and global     CVD risk (Framingham risk profile) as well as the therapeutic effects of CR exercise on the     severity of RA.      This study will help to clarify the mechanism(s) by which exercise impacts CVD risk in     patients with inflammatory disease. In addition, the study will show how CR may benefit     patients with inflammatory disease with respect to their ability to exercise, global risk for     cardiovascular disease and quality of life.   "
133705|NCT01534858|"     The purpose of this study is to evaluate the healing of split thickness skin grafts when     treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.   "
133706|NCT01534845|"     1. The management of anaplastic gliomas of WHO grade 3 is currently largely based on          surgery followed by radiotherapy, of which prognosis remains still dismal with the          median survival of 2-5 years. To date, the benefit of chemo for WHO grade 3 gliomas is          unclear of modest at best with conventional cytotoxic agents, and the role of          temozolomide for these entities still is not elucidated.        2. Codeletion of chromosome 1p/19q is considered the most important marker of prognostic          significance in WHO grade 3 gliomas.        3. To project a randomized phase 2 screening trial examining the efficacy of concurrent          chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3          gliomas without codeletion of chromosome 1p/19q.        4. The prognostic significance of methylation status of MGMT and IDH1 mutation as molecular          markers will be also assessed in each arm as key secondary analysis.   "
133707|NCT01534832|"     The study will examine the safety and performance of a new surgical smoke clearance system     designed for use during laparoscopic surgery.   "
133741|NCT01534364|"     The aim of this study is to assess the effect of a diet prior to cardiac surgery on the     common postoperative decline of renal function. Until now, there is no known drug or     procedure to preserve the kidneys from this impairment. Patients with a known kidney disease     are especially at risk. A potential beneficial effect of a diet prior to surgery has been     shown in investigations in mammals, therefore this study will investigate if a preoperative     diet in patients with known kidney disease and scheduled heart surgery can attenuate or     prevent a postoperative loss of kidney function.   "
133748|NCT01534273|"     The purpose of this phase I study in healthy participants will be to evaluate the safety and     tolerability of LY2886721 single and multiple doses, how the body handles the drug and the     drug's effect on the body.   "
133708|NCT01534819|"     Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus Heli-FX     EndoAnchor System in conjunction with commercially available non-Aptus Endografts will be     divided, as appropriate, into two groups.        1. Primary Group- Subjects undergoing initial (primary) endovascular repair of an AAA where          the investigator believes the proximal aortic neck is challenging such that the risk of          failure or fixation and/or sealing is great enough so that the use of the Heli-FX          EndoAnchor System is warranted.        2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the          investigator believes that use of the Heli-FX EndoAnchor System is warranted to A- Treat          existing graft migration and/or type 1a endoleak, with or without the concurrent use of          other devices. B- Treat subjects believed to be at risk for migration and/or Type 1a          endoleak      Subjects must sign an ICF prior to obtaining any study specific information. Subjects are     eligible to be consented up to 30 days post-procedure.      Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post     procedure. Study recommended follow-up is per SVS and ESVS guidance.   "
133709|NCT01534806|"     The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in     combination lead in a larger reduction in pain score compared to prochlorperazine alone when     treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this     combination of medications treats not only the pain but also the associated gastrointestinal     symptoms of migraine. The main outcome of this study is the reduction in the patient's pain     score at 60 minutes from administration of the study medications. Secondary outcomes include     the number of patients achieving complete resolution of the headache while in the ED, the     number of patients requiring additional treatment interventions by the treating physician,     the number of patients with resolution of the associated symptoms like nausea, vomiting,     photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge,     and side effects of the medications.   "
133710|NCT01534793|"     This observational study aims at describing the learning curve of the Holmium Enucleation of     the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.   "
133711|NCT01534780|"     Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7     cm, laparoscopic surgery with intraperitoneal onlay mesh.      Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with     either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd     postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1,     6, 12, 24, 36, 48 and 60 months postoperative.   "
133795|NCT01533636|"     The investigators will collect samples of sputum from healthy volunteers and patients with     cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding     studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the     sputum.      This study has two hypotheses:        1. Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a          fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic          compounds.        2. Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and          Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF          sputum.   "
133712|NCT01534754|"     This is a multi-centre, randomised, double blind, double-dummy, parallel groups,     placebo-controlled trial was conducted in a population of patients suffering from symptomatic     uncomplicated diverticular disease in order to investigate which is the best treatment in     preventing relapses of the disease.      Patients were randomly divided in double-blind fashion in one of the following groups:      Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei     placebo, 1 sachet/day for 10 days/month;      Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800     placebo, 2 tablets/day for 10 days/month;      Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1     sachet/day for 10 days/month;      Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1     sachet/day for 10 days/month.      The main objective was to assess the safety and the efficacy of mesalazine and/or     Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular     disease   "
133713|NCT01534741|"     Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied     Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic     hemodialysis patients Treatment: Each patient will be treated by post-dilution online     hemodiafiltration once with each dialyzer type.      Study objectives: Intraindividual comparison of removal rate of urea, phosphate,     ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and     alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during     post-dilution online hemodiafiltration.      Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea,     phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and     alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects   "
133714|NCT01534728|"     Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of     the global population. Contrary to other chronic infections such as HIV, clearance of HCV is     possible. While much is now known about the response to treatment in chronic HCV patients,     the fact that acute HCV infection is typically asymptomatic (~80% of patients show no     clinical signs) has made it challenging to define the mechanisms involved in spontaneous     clearance.      Immune protection against HCV is thought to be largely dependent upon the CD8 T cell     response. Therefore using the latest T cell detection technology the investigators will     develop a panel of tetramers specific for all potential HCV epitopes. To produce the     tetramers the investigators will utilize HLA ligand exchange technology which allows the     production of very large collections of peptide-HLA multimers for T cell staining. The     investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T     cell epitopes using published viral sequences and algorithm prediction databases. Using this     information the investigators are currently in the process of developing collections of     peptide-HLA multimers for T cell staining. Therefore the investigators require large     lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each     tetramer on the CD3+CD8+ T cells.      The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be     able to test and compare the frequency of possible conserved epitopes present in both HCVg1     and HCVg4 infections. Once developed this technique will allow us to examine all     virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller     quantities of blood. The development of these technologies will also allow us to tailor such     future diagnostic tests to local populations where a viral subspecies is prevalent; for     example using North-African HLA alleles for HCVg4 epitopes.      The work carried out using such assays will provide important immunological correlates of     viral clearance that will impact vaccine design for HCV infections. Finally, the     identification of protective CD8 T cells specific for HCV may allow new diagnostic tools with     predictive powers of disease progression that can be used on any flow cytometer machine.   "
133715|NCT01534715|"     The purpose of this study is to test the safety and tolerability of IMGN529 in patients with     relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).   "
133742|NCT01534351|"     This study is designed to compare safety and efficacy of monotherapy finasteride to     combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic     hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that     concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to     BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from     baseline on the International Prostate Symptoms Score (IPSS) and will be superior with     respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as     measured by percent change from baseline in prostate volume.   "
133716|NCT01534702|"     With current chemotherapy protocols, in 60-80% of patients with acute myeloid leukemia (AML)     the leukemic blasts in the bone marrow can be reduced to < 5%. This is called complete     remission (CR) and is the prerequisite for cure of the disease. During the last years,     several genetic and biologic risk factors for the achievement of CR have been defined, and     the remission rates vary considerably between patient groups with different risk profiles. On     one hand, patients with certain chromosomal or molecular aberrations have very high CR rates     of approximately 90%. Moreover, in some of these patients, molecularly targeted therapies for     specific genetic aberrations are currently evaluated in clinical trials. However, these     genetic aberrations account for only 50-60% of the overall patient population in AML. The     remaining patients have a significantly inferior CR rate of only 50-60% with 30% resistant     disease after two cycles of standard induction chemotherapy. In conclusion, there is need for     improved induction regimens in a large number of adult patients with AML. An improved CR rate     in this patient population will increase the number of patients eligible for intensive     consolidation such as an allogeneic stem cell transplantation and might thereby be the basis     for a better overall outcome. However, there is no clear evidence that this goal can be     achieved with the currently available chemotherapy protocols. Clofarabine     (2-chloro-2-fluoro-deoxy-9-D-arabinofuranosyladenine) is a nucleoside analogon which combines     properties of fludarabine and cladribine. Due to the lack of neurological side effects,     clofarabine could be explored in higher doses than other nucleoside analogues and has shown     considerable antileukemic activity in patients with relapsed or refractory acute leukemias     and elderly AML patients alone or in combination with cytarabine. In addition, the     combination of clofarabine, cytarabine and idarubicin has produced promising results with     acceptable toxicity in patients with relapsed or refractory AML. Based on these initial     studies, there is need for a further optimization of the clofarabine dose in this     combination. The aim of the AMLSG 17-10 study is therefore to evaluate the tolerability and     safety of increasing doses of clofarabine in combination with idarubicin/cytarabine in     patients with high risk AML defined by the genetic and molecular risk profile.   "
133717|NCT01534689|"     The purpose of this study is to determine whether low level laser light is effective in the     treatment of toenail fungus.   "
133718|NCT01534676|"     The purpose of this study is to determine the effects of transfusion of fresh and stored     blood on patients.      The investigators hope to test:        -  whether a similar effect (older stored blood is associated with worse outcomes) is seen          in chronically transfused patients with hemoglobinopathies. This patient population will          also allow the investigators to test whether iron- chelation therapy is beneficial in          this setting.        -  whether washing or cryopreserving the red blood cells has any effect on this outcome.      These findings may explain the immunomodulatory effects of older stored blood in patients and     will help us develop safer transfusion products for patients.   "
133809|NCT01533454|"     The purpose of this study is to test the extent to which incentives, when combined with an     existing evidence-based weight loss program, improve weight loss and weight loss maintenance.     It will also compare the cost-effectiveness of the incentive-based weight loss programs to     the basic program without incentives.   "
134061|NCT01530100|"     This study will examine the use of lower laser therapy to reduce edema and pain in     orthognathics surgery.   "
133719|NCT01534663|"     The aim of this study is to determine whether supplementation of glutamine and fish oil can     improve peripheral skeletal muscle function and metabolism in patients with heart failure.     The investigators propose a randomized, double-blind, placebo controlled study comparing the     combined supplementation of fish oil and glutamine with placebo in patients with stable heart     failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish     oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this     study is the change in muscle functional capacity measured as changes in maximum muscle     strength and fatigability, peak VO2 and exercise time after supplementation. A secondary     outcome is the measurement of systemic and local markers of inflammation.   "
133720|NCT01534650|"     The purpose of this study is to collect kinematic motion data from subjects with movement     disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate     algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements),     dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks     and/or activities of daily living.   "
133721|NCT01534637|"     This pilot clinical trial is studying how well aprepitant works in preventing nausea and     vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer.     Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in     patients receiving chemotherapy and radiation therapy   "
133722|NCT01534624|"     Background:      - Researchers are interested in studying the roles that genes play in drug and alcohol     addiction. Genes seem to account for about half of the differences between people who become     addicted to drugs and people who do not. This study will collect blood and skin cell samples.     These cells will be used to develop stem cells that are useful for studying how genes are     related to drug use and dependence.      Objectives:      - To study genetic and cellular differences between people who are addicted to drugs and     those who are not.      Eligibility:        -  Individuals between 21 and 65 years of age who do not use drugs.        -  Individuals between 21 and 65 years of age who are in treatment with buprenorphine or          methadone.      Design:        -  Participants will be screened with a brief physical exam and medical history.        -  Participants will also answer questions about physical and mental health, quality of          life, and history of drug and alcohol use. A urine sample and cheek swab sample will be          collected.        -  Participants whose genetic samples match the study requirements will be asked to come          back to provide a skin biopsy sample and a second urine sample.   "
133723|NCT01534598|"     Background:      - FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are     experimental cancer treatment drugs. FdCyd may change how genes work in cancer cells. THU     helps keep FdCyd from being broken down by the body. FdCyd and THU have been given to people     on other cancer treatment trials, usually by vein. Researchers want to give FdCyd and THU by     mouth to see if they work against cancers that have not responded to earlier treatments.      Objectives:      - To test oral FdCyd and THU on advanced solid tumors that have not responded to earlier     treatments.      Eligibility:      - Individuals at least 18 years of age who have advanced solid tumors that have not responded     to standard treatments.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected. Imaging studies and tumor samples will used to study the          cancer before treatment.        -  FdCyd and THU will be given in 21-day cycles. THU should be taken 30 minutes before          taking FdCyd.        -  Participants will take FdCyd and THU by mouth, once a day, for 3 days at the beginning          of the first and second weeks of each cycle (days 1 3 and 8 10). The drugs will not be          taken during the entire third week of each cycle.        -  Treatment will be monitored with frequent blood tests and imaging studies.        -  Treatment will continue as long as the cancer is responding to the drugs and serious          side effects do not develop....   "
133743|NCT01534338|"     The primary aim of the study is to test the effect of mindfulness training on sleep     parameters among older adults with insomnia symptoms      The secondary aims are to examine if changes in mindfulness meditation practice (daily log)     and level of mindfulness (self-report) are associated with changes in sleep parameters, and     to determine if mindfulness training is associated with in vitro biological markers of     peripheral inflammation   "
133724|NCT01534585|"     Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation     therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer.     Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC.     However, concurrent chemoradiotherapy increased significantly local and systemic toxic     effects, which may preclude many patients from proceeding with combined therapy. The     epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is     overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter     survival following chemoradiotherapy in locoregionally advanced NPC. And some basic     researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the     radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line.     Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib     hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base     on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in     combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The     prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in     patients with NPC. This regimen is of great interest and it has potential to alleviate the     adverse effects, improve patient compliance and better therapeutic ratio.   "
133725|NCT01534572|"     There is a constant exchange between the gut epithelium and lumen, including microbial     interplay. The aim of this study was to investigate dietary test products on inflammatory     proliferation markers in the gut, and thereby if the products had positive effects in the gut     as well as in other parts of the body.      The hypothesis was that the test products would reduce the inflammatory and proliferation     activity of the gut epithelium by fermentation of normal food products and by converting     dietary phenolic compounds into anti-inflammatory substances.   "
133842|NCT01533012|"     The purpose of this study is to investigate a performance of initial positioning of left     sided double lumen endobronchial tubes using peak inspiratory pressures difference between     two lungs.   "
133726|NCT01534559|"     It widely accepted that a number of medication related problems can occur after the patient     has been discharged from the hospital. An obvious extension of the ongoing integrated     medicines management programme (IMMP) is therefore to provide a medicines management clinic     within an outpatient setting as well as follow-up telephone calls from a clinical pharmacist.     This study aims to assess the influence a pharmacist-led medicines management outpatient     service on patients at high risk of medication related problems.      It is anticipated that this service will        -  Ensure continuity of pharmaceutical care for patients post discharge.        -  Reinforce patient education in order to improve knowledge and understanding of the          medication prescribed.        -  Ensure that both prescription medicines and OTC preparations are used appropriately.        -  Facilitate the communication with other members of healthcare team in order to agree and          implement measures to overcome medication related problems.   "
133727|NCT01534546|"     Peri-operative treatment of locally advanced gastric cancer (LAGC) has always been argued by     eastern and western scholars. For patients with clinical stage of cT4b/N+M0, or cT4aN+M0, the     prognosis is rather poor, and the primary lesions might not be resectable at the time of     diagnosis. MAGIC study has showed that pre-and post-operative chemotherapy with 3 cycles of     ECF has increased 13% on 5yOS compared with surgery alone; However, eastern studies such as     ACTS GC or CLASSIC showed that TS-1 monotherapy or XELOX (oxaliplatin/capecitabine)     combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery     could achieve the significant survival benefit. So whether perioperative or post operative     therapy is more beneficial for LAGC patients lacks of data supported by prospective study.      So in this prospective randomized phase III study, the investigators aim to compare the     survival benefit as well as the safety for SOX (oxaliplatin/TS-1) as perioperative therapy     versus SOX or XELOX as postoperative therapy after D2 dissection.   "
133728|NCT01534533|"     This study is to investigate the possible positive effects of lutein and lycopene     supplementation on early atherosclerosis in Beijing.   "
133729|NCT01534520|"     This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is     effective at decreasing pain during intrauterine device insertion in nulliparous women.   "
133730|NCT01534507|"     Irritable bowel syndrome, (IBS) is a common functional disorder of the gut that can be quite     disabling to patients. The most common symptoms of IBS are abdominal pain or discomfort along     with erratic changes in bowel habit of diarrhoea, constipation or a mixture of the two     (referred to as IBS subtypes). Despite much research efforts to further understand the     pathophysiology of IBS; as yet no specific biomarkers/definitive measurements have been     identified that can be use to aid the diagnosis and reduce the need for unnecessary,     unpleasant and expensive tests.      Evidence shows that anxiety plays a part in IBS and can speed up transit time in the small     bowel. In this study, the investigators hypothesise that since anxiety is a common feature of     IBS, then fast small bowel transit is likely to be found in all subtypes of IBS and the     difference in stool frequency and consistency in IBS subgroups are therefore likely to     reflect differences in colonic function. The investigator wish to test this by measuring both     small and large bowel transit times using Magnetic Resonance Imaging (MRI) and validate the     results of the MRI with two methods currently used in clinical practice -The previously     validated lactose-C13 Ureide breath test (for small bowel transit) and the standard     radio-opaque pellet method to assess the whole gut transit (WGT) time.   "
133744|NCT01534325|"     The purpose of this study is to determine whether the SD unique device is effective in     treatment of overweight and obesity.   "
133745|NCT01534312|"     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent     colitis and using human in vitro inflammation models. Its use as a food ingredient has proven     safe and with no influence on dietary intake. We hypothesize that orally administered CGMP     has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.   "
133746|NCT01534299|"     This is a prospective, multi-center, single-arm, non-interventional and open-label registry.     The purpose of the registry is to document the long-term safety and effectiveness of renal     denervation in a real world patient population with hypertension and gathering data for other     diseases characterized by elevated sympathetic drive, such as diabetes mellitus type 2, renal     insufficiency, etc. The Global Symplicity Registry will consecutively enroll 3000 patients     who undergo the renal denervation procedure, from over 200 sites worldwide.   "
133774|NCT01533922|"     The primary objective of this trial is to investigate the effect of 6 weeks treatment with     tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and     exercise tolerance in patients with COPD   "
133731|NCT01534494|"     This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin     in alcohol dependent participants, demonstrate the feasibility of the integrated     behavioral/pharmacologic intervention, and provide preliminary outcome and safety data.     Participants will receive psilocybin orally in two all-day administration sessions, conducted     in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in     recent studies. Psilocybin administration will occur in the context of a behavioral     intervention including a total of 12 sessions over 12 weeks, incorporating Motivational     Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational     Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before     and debriefing after the psilocybin administration sessions. The MET will incorporate     attention to spirituality as well as drinking behavior as a primary subject of change.     Drinking outcomes and changes in several potential mediators of treatment effect, including     motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the     experience, will be measured during treatment and for 24 weeks after the end of treatment.     The investigators hypothesize that drinking will decrease following the psilocybin sessions,     and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks     vs. baseline) will be observed among study participants.   "
133732|NCT01534481|"     The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26     months of donor human milk as compared to preterm infant formula as the in-hospital diet for     infants whose mothers choose not to provide breast milk or are able to provide only a minimal     amount. Infants will be randomized to receive donor breast milk or formula during their     hospital stay. Infant's will be followed until they reach 22-26 months of age.   "
133734|NCT01534455|"     -  Lapatinib in combination with capecitabine has been approved for the treatment of women          with HER-2-positive advanced breast cancer that have progressed after anthracycline-,          taxane-, and trastuzumab-containing therapies. The use of this combination is limited by          overlapping toxicity such as diarrhea and cutaneous side effects.        -  A significant number of patients receive today capecitabine with trastuzumab as first-          or second-line treatment. Therefore, other combinations of lapatinib with less toxic          cytotoxic agents are needed.        -  Eribulin mesylate (E7389) is a synthetic analog of Halichondrin B (HalB), a large          polyether macrolide isolated from a marine sponge. Eribulin is a mechanistically unique          antagonist of microtubule dynamics among tubulin-targeted agents, leading to inhibition          of microtubule growth in the absence of effects on microtubule shortening, and formation          of non- productive tubulin aggregates.        -  Eribulin mesylate at a dose of 1.4 mg/m² given on day 1, 8 every 3 weeks has shown          better overall survival by 2.5 months compared to treatment of physicians choice in          patients with locally advanced or metastatic breast cancer who were previously treated          for 2-5 lines with anthracyclines, taxanes, and capecitabine (EMBRACE study).        -  The most frequently reported eribulin-related AEs were asthenia/fatigue (65%), alopecia          (60%), neutropenia (60%), nausea (44%), anemia (28%), pyrexia (23%), leucopenia (22%),          anorexia (21%), constipation (19%), vomiting (18%), and peripheral neuropathy (5.5%;          only grade 3). Grade 4 neutropenia occurred in 32% of patients, and febrile neutropenia          occurred in 5.5% of patients. The frequency of all other grade 3/4 AEs was less than 3%.          This toxicity profile does not overlap with that of lapatinib.        -  There is uncertainty in how far a once every 3 week schedule of eribulin mesylate at a          dose of 2.0 mg/m² would be better tolerated. Several phase II studies are currently          conducted in various non-breast cancer indications to compare the d1+8 q d21 with a d1 q          d21 schedule.        -  The aim of this randomized phase II study is to compare the efficacy and tolerability of          two dose-schedules of eribulin plus lapatinib in HER2-positive breast cancer,          pre-treated with trastuzumab in the adjuvant and/or metastatic setting.   "
133735|NCT01534442|"     The aim of this study is to investigate the role of transmission of vagal cholinerg for the     GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin     response by using atropin administration.      The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous     system and for this reason the investigators will research individuals with an intact nervous     supply with and without atropin administration.   "
133736|NCT01534429|"     Increasing experience has identified post-herniorraphy chronic pain as an under-recognized     and important complication. Nerve entrapment and injury are recognized as causes of such     pain. Operative treatment for selected patients with this condition includes surgical     exploration of the affected groin, identification and removal of involved nerves, and removal     of meshoma. This procedure has been highly effective in treatment of chronic pain. This study     will attempt to subjectively and objectively evaluate the patient's chronic groin pain using     quantitative sensory testing (QST) and validated pain scales and questionnaires. Quantitative     sensory testing is a method used to assess damage to the small and large nerve fibers. It is     used to diagnose and assess the severity of nerve damage, and can also help to determine if a     neuropathy is responding to treatment. QST uses a computer testing system to measure how     nerves react to vibration and changes in temperature. The procedure is non-invasive and the     patient will feel minimal to no discomfort during testing. The hypothesis is that any     decrease in subjective pain scores would be accompanied by improved QST results.   "
133737|NCT01534416|"     The purpose of this study is to determine the effectiveness of placing numbing medication     around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain     after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted     myomectomies. It will assess whether patients who receive the medication experience less pain     and require less pain medication post operatively and if it helps reduce the number of     patients who require hospitalization for pain control following surgery.   "
133738|NCT01534403|"     The study is an open-labeled extension study to continue to assess the safety and     tolerability of Epratuzumab in moderate to severe SLE subjects who have previously     participated in SL0026 [NCT01449071] phase I/II trial.   "
133739|NCT01534390|"     Studies showed that infusion or injection of drugs and fluids results in introduction of     microparticles into the bloodstream. These microparticles may cause organ damage and     stimulate the immune system thus aggravating the underlying disease. Given that critically     ill patients are characteristically suffering from a high disease severity and receive large     amounts of fluids and drugs, they may be at particular risk of harm by these microparticles.     In-line microfilters have been shown to clear microparticles from intravenous drugs and     solutions. The investigators hypothesize that use of in-line microfilters reduce the days     with the systemic inflammatory response syndrome in adult critically ill patients.   "
133740|NCT01534377|"     This study will evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A)     for the treatment of depression and prevention of depression in maltreated and nonmaltreated     girls between the ages of 13-15 years old.   "
133749|NCT01534260|"     This research is being done because treatment options are very limited and usually     unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with     disease that has relapsed and/or proven resistant to standard therapy. Subjects are invited     to participate in this study that will examine the use of three drugs called Sorafenib     (Nexavar), Vorinostat (Zolinza) and Bortezomib (Velcade) for treating acute myeloid leukemia.   "
133750|NCT01534247|"     The purpose of the study is to assess whether there is any pharmacokinetic interactions     between CAZ-AVI and metronidazole.   "
133751|NCT01534234|"     The objective of this study is to assess the safety and effectiveness of the automatic     atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in     the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device     (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of     the atrial pacing lead, and compatible SmartView programming software.      This study will evaluate the effectiveness of the automatic optimization algorithm in     increasing the rate of patients responding to the therapy as compared to an echocardiographic     optimization method.      This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.   "
133762|NCT01534078|"     Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a     protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the     antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy     portion, which attempts to destroy the cell.      The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you     will receive in this research study are approved for use in people with Hodgkin Lymphoma. A     drug called bleomycin is usually included with AVD, but since it appears to be a less     effective drug with significant potential risks, it is being replaced in this study with the     drug brentuximab.      In this research study, the investigators are looking to see whether brentuximab in     combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.   "
133752|NCT01534221|"     The superiority of a percutaneous coronary intervention (PCI) by one stent over another in     terms of clinical outcome is usually documented in large randomized controlled trials (RCT).     Although generated from selected study populations these data form the basis for evidence     based practice (EBP) in the entire population of patients considered for coronary     intervention. An inherent limitation of this approach is that study populations differ     significantly from all comers in terms of patient characteristics and prognosis undermining     the foundation for extrapolation of trial results to all comers. Furthermore, other trials     are based on a one-fits-all concept, while the benefits of an individual-tailored     approach that might be superior, is not investigated.      The Purpose of the current study is to        -  Compare clinical outcome between several CE marked drug eluting stents        -  Compare clinical outcome between several CE marked bare metal stents        -  Compare clinical outcome in all comers with that of the selected study population of          RCT's        -  Evolve methods to compare clinical outcomes between the generalized one-fits-all          versus the individualized or individual-tailored stent selection approaches      The Method employed is        -  All comer PCI registry - single centre        -  Randomisation of all eligible patients within the registry to one of several study stent        -  Quality assurance in non-randomized population within the registry by periodical          alternating the institutional standard stent        -  Continuous follow up of all patients included the registry by means of systematic event          detection and classification by an independent safety and end point committee        -  Assessment of effects on quality of life by heart and health questionnaires      Outcome Measures      Primary endpoints:        -  Composite of cardiac death, acute myocardial infraction and target vessel          revascularisation        -  Stent thrombosis        -  A specifically developed Treatment Failure Rate classification      Secondary outcome measures include each of the above, target lesion revascularisation and     total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years.      Tertiary outcome measure is self reported quality of life based on health questionnaires on     general health and cardiac symptoms.      Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an     absolute difference of 5%), P< 5%, Power > 80% => 900 patients in each of two treatment arms.      Prespecified Analysis include        1. The MACE rates between stent types        2. The Stent thrombosis rates between stent types        3. The Treatment failure rates between stent types        4. The randomized population versus non-randomized population        5. The individualized versus the generalized Population        6. QOL between stent types   "
133753|NCT01534208|"     ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men     with secondary hypogonadism.   "
133754|NCT01534195|"     The purpose of this study is to evaluate the effectiveness of the modified Conjunctival     Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to     treatment with a proven ocular anti-inflammatory medication,      Prednisolone, assessed by the following measures:        -  Ocular itching        -  Conjunctival redness   "
133755|NCT01534182|"     A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient     Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing     Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease     Modifying Therapy.   "
133756|NCT01534169|"     Antithyroid drugs is the first choice treatment of Graves' disease in China and Europe.     However,the relapse rate is very high (40-60%) after therapy withdrawal, and many patients     need further treatment. In our previous study, a new treatment strategy for GD has been     introduced. After methimazole (18 months) combined with intrathyroid injection of     dexamethasone (DEX) (3 months) treatment, the relapse rate of hyperthyroidism was markedly     reduced compared with methimazole treatment alone (7.4% versus 51%) during the 2-year     follow-up period. The results have been published in the 'J Clin Endocrinol Metab,     2009,94:4984-4991'. However, the mechanism by which the DEX reduces the relapse rate of GD is     not fully understood. In vitro study, we have proven that DEX could effectively improve the     function of regulatory T (Treg) cells and set up a new balance of T helper 1(Th1)/Th2 in GD     patients(this results have been in press in the Eur J Endocrinol). In order to elucidate     mechanism of this treatment strategy in vivo, we plan to recruit 20-30 patients with GD and     treat those patients by intrathyroid injection of DEX combined with methimazole, and the     function of Treg cells and balance of Th1/Th2 will be evaluated.   "
133757|NCT01534143|"     This pilot phase II trial studies how well giving high dose busulfan together with bortezomib     works in treating patients with high risk multiple myeloma undergoing stem cell transplant.     Drugs used in chemotherapy, such as busulfan, work in different ways to stop the growth of     cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may     stop the growth of cancer cells by blocking some of the enzymes needed for cells growth.     Giving busulfan together with bortezomib before a stem cell transplant may kill more cancer     cells   "
133758|NCT01534130|"     The investigators will conduct acupuncture for participants with chronic fatigue     syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep     structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to     investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye     movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for     it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the     fatigue, reducing accompanying symptoms and for improving the life quality of CFS.   "
133759|NCT01534117|"     The investigators are assessing the platelet function analysis of those who sustained     significant head trauma while on aspirin or plavix and to assess if any qualitative     difference is obtained if platelets are administered.   "
133775|NCT01533909|"     The aim of the study is to develop a screenings tool that will enable hospital nurses to     detect and stage cancer cachectic patients. The early detection and staging of cancer     cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made     patient care.   "
134192|NCT01528384|"     This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients     who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior     treatments. The study hypothesis is that this drug will be safe in pediatric patients.   "
133760|NCT01534104|"     Many patients with brain tumors require surgery. Some patients have brain tumors near     important parts of the brain. These brain areas have roles in language or motor function.     Avoiding these motor and language areas helps to prevent neurological deficits. The     investigators are studying the parts of the brain involved in motor and language. Patients     usually get functional MRI (fMRI) or resting-state fMRI (rs-fMRI) for gray matter mapping and     diffusion tensor imaging (DTI) or diffusion spectrum imaging (DSI) for white matter mapping.     These special MRI sequences are used to plan surgery. Patients are scheduled to have imaging     to help plan for possible surgery.      Some patients may require stimulation during surgery to motor and language areas. In patients     who require stimulation as part of their standard of care, the investigators will compare the     investigators imaging results with the stimulation results. The purpose of this study is to     improve MRI mapping of the motor and language pathways in the brain.      The scans are necessary stimulation for this protocol are part of the standard of care. In     other words, these tests are done as part of the best possible care even if they did not join     this study. The investigators are studying new techniques for analyzing the MRI data. These     new techniques may give the doctor a better view of where the brain tumor is located relative     to important parts of the brain.      The investigators will only perform the test sequences that are necessary for mapping the     tumor. Most patients will require both fMRI and DTI. Some patients may only require fMRI or     DTI. The investigators may also ask to perform optional sequences during the scan. Multi-echo     is an modified form of fMRI. DSI is a modified form of DTI. These optional sequences are for     research only. The patient would not get these sequences if they do not enroll in this study.   "
133761|NCT01534091|"     The purpose of this study is to examine if internet supervised by pedometer will contribute     to enhance the amount of physical activity at leisure time by obese children.      The investigators hypothesize that using pedometer will increase the amount of physical     activity done by obese children in the afternoon and will improve the likelihood of success     in the intervention program.   "
133766|NCT01534026|"     Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as     a pump to move blood around the body. Aspirin has been traditionally used in heart failure     because a tendency towards blood clots (including stroke and heart attack, clots in the legs     and in the lungs) has been observed in this group and aspirin's mechanism of action is to     prevent blood clots. This is important because two-thirds of cases of heart failure are     caused by a blood clot in the coronary artery resulting in a heart attack, and aspirin is     given to reduce the chances of further heart attacks.      However aspirin was introduced before clinical trials as the investigators know them now were     run. Systematic review of the trials of aspirin in heart failure has shown that its use does     not increase survival, and there is no evidence to recommend its routine use. Another     important finding was that use of aspirin may reduce the beneficial effects of ACE inhibitors     which do have a mortality benefit, and that aspirin was associated with an increase in     hospitalisation for heart failure compared to other drugs which prevent clots or placebo.      The investigators propose that the use of aspirin in heart failure that is not caused by     heart attacks (non-ischaemic cardiomyopathy) is unnecessary and could be stopped. The     importance of finding evidence to cease unproven medications in heart failure cannot be     understated. Patients with heart failure take an average of six prescription medications each     day. Each medication has side effects and the interactions of all the drugs together are     unknown. Aspirin itself is a drug which frequently has side effects of increased risk of     bleeding, gastrointestinal ulceration, as well as kidney impairment.      In this study, the investigators plan to withdraw aspirin from patients with stable     non-ischaemic heart failure in a closely monitored environment and watch for the effect of     this on heart failure.   "
133767|NCT01534013|"     The purpose of the study is to assess the safety and efficacy of the Imperial College closed     loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.   "
133768|NCT01534000|"     Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective     randomized controlled trial designed to evaluate the clinical value of cardiac multidetector     computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest     pain, compared to a conventional functional-based testing strategy.      Methods:      Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal     electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary     angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial     perfusion imaging - MPI (Control group).      After one year, patients will be followed-up, with registration of clinical endpoints such as     Cardiac death, myocardial infarction, need for revascularisation, admittance for heart     related problems, sustained chest pain, live quality score, use of medication.   "
133769|NCT01533987|"     The purpose of the study is to determine the effects of daily ingestion of Juice Plus+®     capsules containing Orchard, Garden and Vineyard blends on endothelial function and     biomarkers of oxidative stress (oxidized LDL, lipid hydroperoxides and protein carbonyls) in     overweight men as compared to the placebo group.   "
133770|NCT01533974|"     The overall aim of this 5-year project is to capitalize on the strong theoretical and     promising empirical evidence for Acceptance & Commitment Therapy (ACT) as an intervention for     smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral     therapy (CBT) counseling when both are offered with nicotine replacement therapy (NRT) and     delivered within a real world healthcare setting.   "
133771|NCT01533961|"     This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158     in healthy volunteers. In animal models of both acute and chronic experimental     Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.   "
133772|NCT01533948|"     This phase II trial studies how well axitinib works in treating patients with melanoma that     has spread to other places in the body or cannot be removed by surgery. Axitinib may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
133773|NCT01533935|"     The primary objective of this trial is to investigate the effect of 6 weeks treatment with     tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and     exercise tolerance in patients with COPD.   "
133776|NCT01533896|"     Parents should receive anticipatory guidance about obesity prevention as part of the routine     well child visit. Educational resources are needed to help physicians routinely provide these     important anticipatory guidance messages. In this study, consecutive parents will be exposed     to routine anticipatory guidance messages before the well child visit with the physician.     After the clinic visit, parents will be invited to participate in a research study to     determine if they plan any changes at home. The key research question of this study is: Can a     brief multimedia intervention help parents develop plans to help their children have a     healthy weight?   "
133777|NCT01533883|"     Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a     transfemoral delivery system. The aim of this study is to evaluate the performance and safety     of the Cardioband for repair of mitral regurgitation.   "
133778|NCT01533870|"     Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of     NKTR-118.   "
133779|NCT01533857|"     This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose     to healthy males.   "
133780|NCT01533844|"     The objective of this multi-center, prospective observational study is to determine the     feasibility of a potential interventional study with fidaxomicin. The incidence and clinical     aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will     be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy     might improve outcome.   "
133781|NCT01533818|"     The aim of the study is to determine optimal management of isolated fast breathing in young     infants in a trial design conducted in primary care settings.      The investigators hypothesized that proportion of infants who fail therapy will be 4% in each     group. A 6% or less difference in failure rate will be considered equivalent.   "
133782|NCT01533805|"     The purpose of this study is to compare different methods of application of the Pilates     Method with exercises in controlling in low back pain in women aged between 45 and 60 years.     Two groups will be formed. One will do Pilates exercises with stabilization segmental. The     other group will do classic Pilates exercises. Will be measure pre and pos intervention of     the responses already shown above.   "
133783|NCT01533792|"     Objective: The objective of this research was to compare the effect of a single session     supragingival scaling in a group of pregnant women with periodontal disease with a group that     received supra and subgingival scaling.      Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4     teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing     in the same place. Women were divided into two groups, the group 1 received supra and     subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received     only supragingival scaling with OHO too.   "
133784|NCT01533779|"     Examine neutrophil extracellular traps (NETs) formation, in relation to other neutrophil     functions like chemotaxis, superoxide production, hydrogen peroxide production, and the     presence of myeloperoxidase, in pediatric patients undergoing chemotherpy for solid and     hematological malignancies. This data could shed new light on the mechanism responsible for     the increased susceptibility to infection among these patients and aid in improving their     prophylactic antimicrobial treatment.      NETs formation against tumor cell lines and their ability to kill tumor cells will also be     examined. The finding of NETs activity against tumor cells could have a major contribution to     the investigators understanding of the function of the immune system against cancer.   "
133785|NCT01533766|"     The purpose of this study is to compare the safety and efficacy of CombiflexOmega in     comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.   "
133786|NCT01533753|"     The purpose of this study is to assess the change in quality of life over a 6 month period     between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes     related to androgen deprivation therapy.   "
133787|NCT01533740|"     Aim of the present study is to investigate whether baseline or early post-treatment (one     month after treatment commencement) frequency of peripheral T regulatory lymphocytes (Tregs     OR CD4+/CD25high/FOXP3+ T cells), known to suppress antitumor immune response, may influence     long-term clinical outcome (i.e. radiological response, progression-free survival or overall     survival) in metastatic colorectal cancer patients treated with a standard first-line     chemotherapy including fluorouracil, irinotecan and bevacizumab   "
133788|NCT01533727|"     Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main     treatment for early stage patients is surgical resection, but about 30% -70% patients will     relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection     NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic     adjuvant chemotherapy. It is necessary to further improve the survival time of patients with     lung cancer. Biological treatment is becoming a new treatment modality for Cancer following     with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant     treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK)     characterized as fast amplification, strong anti-cancer activity and broad anti-tumor     spectrum is most widely used and thought to be the first choice for the new generation of     anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of     Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for     stage IB-IIIA NSCLC.   "
133789|NCT01533714|"     The primary objective of this study is to assess the long-term safety of CDP6038.   "
133790|NCT01533701|"     The purpose of this study is to compare lactate and total acid-base status in fetal scalp     blood with lactate and total acid-base status in maternal blood and amniotic fluids to     provide information on how lactate and base deficit correlates with scalp samples.      Furthermore, the investigators want to study whether angiogenic factors in fluids above may     be a possible marker of asphyxia during labor.   "
133791|NCT01533688|"     Poor bowel preparation and patient intolerance of the procedure are the most important     factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in     incomplete testing, increased potential to miss lesions, increased cost, and decreased     patient satisfaction. The investigators hope to gain better insight into which bowel     preparation works best in diabetic patients and hence would increase patient satisfaction,     tolerability of the bowel preparation and decrease overall costs. The investigators will     investigate which bowel preparation for colonoscopy will work optimally in diabetic patients     using three different regimens.   "
133792|NCT01533675|"     Sutures are an integral part of surgery and available materials are diverse, as are the     options for post-procedure care. Both saline and hydrogen peroxide are commonly used     cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on     the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.   "
133793|NCT01533662|"     Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This     loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation     resulting in hypotension. A severe and prolonged hypotension can compromise regional     perfusion and worse outcome especially in very elderly patients. Moreover the venous     vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a     cardiac output decrease. Several authors had identified the prevention of hypotension as a     key role during spinal anesthesia although none prophylactic treatment has been identified.     Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous     spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension.     Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist     and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for     preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery.     The investigators want to assess for the first time the prophylactic phenylephrine infusion     for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under     spinal anesthesia single injection.   "
133794|NCT01533649|"     The assumption of the unpredictability of seizures may have an enormous impact on the     perception of self-efficacy and may contribute more to a patient's poor quality-of-life than     the actual seizures. Patients with epilepsy are especially susceptible to the influence of     the arbitrary nature of this condition on socialization,education,and the formation of     self-identity. Consequentially, the psychosocial and psychological aftermath is likely to be     observed even in individuals with well-controlled seizures. The relationship between seizure     occurrence and the effects of having epileptic seizures on quality of life can be     characterized as reciprocal; e.g. emotional stress is not only a result of having seizures;     it is also the most frequently reported seizure precipitant. Whereas behavioral interventions     have repeatedly been considered as the third pillar of the treatment of epilepsy, the main     focus still remains on passive seizure control per pharmacological and surgical     interventions, which may further aggravate victimization. Outcome after epilepsy surgery is     closely correlated with pre-surgical characteristics. Consequentially, there is an upsurge of     interest in the medical community for research on non-pharmacologic interventions to     facilitate the transition from chronically sick to well with preventive therapeutic     interventions in the context of habitual seizures. The Andrews/Reiter (AR) approach to     epilepsy is a systematic counseling intervention that assists the individual to identify     seizure warning signs,seizure precipitants and general life stressors in order to develop     strategies of active seizure control and improve self-defined life quality. Literature review     indicates that AR represents the most comprehensively developed psychological approach. The     proposed trial will address the question if AR decreases seizure frequency and     psychopathologic comorbidities and increases seizure self-efficacy and overall quality of     life in patients with medically intractable epilepsy.   "
133796|NCT01533623|"     The investigators will perform a 1-year clinical trial measuring objective compliance during     mandibular advancement device (MAD) treatment.      The investigators will enroll 50 patients that received treatment with a titratable, duobloc     MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study     Objective versus subjective compliance with oral appliance therapy for obstructive sleep     apnea hypopnea syndrome, registered at Clinical Trials.gov (NCT01284881).      Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by     the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be     done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample     interval, the capacity of the active microsensor allows for data acquisition during a 100 day     period.      A follow-up appointment is scheduled +/- 265 days after the start of the original study. A     second follow-up visit is scheduled again 1 year after the start of the original study.      The objective measurement of MAD wear time (total hours of wear time and the mean hours of     wear per night over the respective period) will be based on the assumption that the MAD has     been worn when the chip records a temperature intraorally.   "
133797|NCT01533610|"     RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress     disorder (PTSD).      PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve     block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era)     induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part     of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).   "
133798|NCT01533597|"     The aim of the study is to investigate if the combination therapy consisting of     anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive     Bladder (OAB).   "
133799|NCT01533584|"     The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood     pressure and home blood pressure (BP) measurements through a) comparison of mean BP and     nocturnal dipping assessed with the two methods, b) correlation of those parameters with     parameters of target-organ damage and c) comparison of the potential of the two methods to     define non-dippers.   "
133800|NCT01533571|"     This study aims to examine dimensional alveolar ridge alterations and prevent buccal plate     resorption and soft tissue recession following immediate implant placement in extraction     sockets in the maxillary esthetic zone using different socket morphology-guided treatment     modalities.      Expected results of the study are:        -  To have found the optimal materials and GBR procedures modalities for buccal plate          resorption degree reduction;        -  Soft tissue recession and best esthetic result achievement. There will be possibilities          to study socket morphology influence on final esthetic result achievement.   "
133801|NCT01533558|"     The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to     non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU     patients, who will get caspofungin as standard care.      Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be     taken daily.   "
133802|NCT01533545|"     The aim of this study is to determine the effect of epinephrine on systemic absorption of     local anaesthetic mepivacaine administered for brachial plexus block in uremic patients     scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of     epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.   "
133803|NCT01533532|"     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with     endometriosis.   "
133804|NCT01533519|"     This study is designed to investigate the safety of intranasal administration of NPY using a     dose escalation, randomized, double-blinded, placebo-controlled crossover design in a     medication-free, symptomatic PTSD group.   "
133805|NCT01533506|"     The patient has failed all other available agents and has intractable epilepsy due to Dravet     Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy     with Stiripentol are primarily to significantly reduce the frequency and severity of     seizures.   "
133806|NCT01533493|"     This is a 12-week clinical trial evaluating the efficacy and safety of memantine     hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with     Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with     OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of treatment     with memantine on ADHD symptoms. Following screening procedures, memantine is prescribed in     randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along     with open-label OROS-MPH (everyone receives medication).   "
133807|NCT01533480|"     The investigators are conducting this study because the patient have an eye infection which     is called adenoviral conjunctivitis, and is the most common cause of pink eye. There is     currently no treatment for this condition. However, the researchers associated with this     study want to understand if using a product called Zirgan, which is a topical ointment that     is already FDA-approved for other types of eye infections, will help with the type of     infection that the patient currently have. Zirgan is not FDA-approved to treat your type of     eye infection. Your participation in this study is expected to last 21 days but the patient     will only apply the topical ointment for 14 of those days. During the study, the patient will     be asked to come into this clinic 8 times.      The purpose of this study is to determine whether topical Zirgan can reduce days that the     patient suffers from the eye infection, and also to see if it can prevent the infection from     spreading to your second eye and to also see if it can prevent the spreading of the infection     to people that the patient come in close contact with.      Zirgan will be compared to Genteal Gel in this trial. Genteal Gel is a non-prescription eye     lubricant gel and is commonly used for treatment of dry eye.      The patient will be asked to apply a topical ointment (either Zirgan or Genteal gel 5 times a     day for the first 7 days and then 3 times a day for the following 7 days. The patient will be     asked to return to the clinic 21 days after the patient starts the study for a final     check-up.      It is planned that about 80 people with Adenovirus Conjunctivitis will be enrolled in this     study between 8-12 sites across the United States.      The patient will be assigned to either Zirgan or Genteal gel by chance which is similar to     flipping a coin.      The study groups will be assigned in a 1:1 ratio. Neither the patient nor the study doctor or     study staff will be able to pick which study group The patient is in. The patient will not     know and the study doctor or study staff will not know which study group the patient is in.     The study doctor or study staff can find out if it is necessary to know for your health. If     this happens, the study doctor or study staff may not be able to tell the patient which study     group the patient was in until everyone finishes the study.   "
133808|NCT01533467|"     Objective:      To investigate the protective effects of a newly invented device for reducing tears in the     perineum during vaginal childbirth.      Design:      A multicenter randomized control trial performed at three hospitals in Sweden, in     Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200),     cephalic presentation. They will be randomized to an intervention group, with a perineal     protection device, and a control group deliver as normal.      Main outcome measures:      The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter     rupture are measured.   "
133810|NCT01533441|"     The objective of the SAFE K study is to demonstrate that in patients treated with the     antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally     produced by the ferments used in fermented dairy products, does not upset the balance of     anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo     for four months after a 4-month run-in period.In addition, the study evaluates if regular     consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment     and improve the markers of bone mineralisation.   "
133811|NCT01533428|"     The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin     8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused     by diabetes.   "
133812|NCT01533415|"     Is CES effective in the treatment of anxiety when accounting for any comorbid conditions and     or current treatments including medication and psychotherapy.   "
133813|NCT01533402|"     The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a     feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia,     panic disorder, specific phobia, generalized anxiety disorder or separation anxiety     disorder). The program is directed toward both the parents and children. The patients work     with the treatment is supported through on-line contact with a therapist. Approximately 128     patients will be included in the study and randomized to either condition. All included     patients are assessed before the treatment starts and after 10 weeks (post treatment).     Follow-up assessments are conducted at 3 and 12 months after treatment.   "
133814|NCT01533389|"     A lower ureteral calculus, which measures 5 millimeters and less, may be easily expelled by     symptomatic therapy. Actually, it has about a 50% chance of successful expulsion.      However, a complication such as urinary tract infection or hydronephrosis or persistent pain     may occur before it is expelled. Thus, it is imperative to minimize the occurrence of     complications in the process of expectant treatment and also to reduce the time required to     expel calculi.      Pharmacotherapy is to relieve ureteral obstruction and thus to expel urinary calculi easily.      This clinical trial is to evaluate the efficacy of silodosin, a selective α1A-blocker, on     calculous expulsion in expectant treatment for patients with lower and mid ureteral calculi.   "
133815|NCT01533376|"     Primary Objective:      • To assess the possible utility of topical timolol in the management of port-wine mark (PWM)     in Sturge-Weber syndrome in children.   "
133816|NCT01533363|"     The purpose of this study was to determine the influence on Patient comfort after Stapled     Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular     hemorrhoids.   "
135605|NCT01509807|"     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome     injectable suspension) to determine if total opioid consumption is reduced when using     EXPAREL, therefore possibly reducing total hospitalization costs.   "
133817|NCT01533350|"     Twenty eight infertile women undergoing ultrasonographic endometrial assessment in the late     follicle phase, fourteen of them with homogeneous echo endometrium (group 1) and other     fourteen with trilaminar endometrium (group 2), were included from our Department. The     endometrial tissues were collected and Four biomarkers for endometrial receptivity and     ultrastructure were assessed before and 6-7 days after ovulation.   "
133818|NCT01533337|"     The aim of the current report is to investigate the feasibility of transferring the free     dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to     reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed     digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of     the donor middle and ring fingers was measured.   "
133819|NCT01533324|"     S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in     Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good     efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is     better than common course 4 week regimen in tolerance. So the investigators want to examine     the efficiency and safety of SL one week on and one week off regimen in HCC.   "
133820|NCT01533311|"     The nonpolypoid colorectal neoplasms (NP-CRNs) are relatively common in patients with     gastrointestinal alarm systoms. The depressed lesions have a greater risk of having cancer     than flat and polypoid lesions.   "
133821|NCT01533298|"     The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in     comparison to SmofKabiven peripheral in postoperative patients requiring parenteral     nutrition.   "
133822|NCT01533285|"     The purpose of this study is to explore the effect of an inflammatory and a psychosocial     stressor and the combination thereof on mood in healthy young and elderly participants and     patients with Major Depressive Disorder (MDD).   "
133823|NCT01533272|"     As a measure of secondary prophylaxis, and with the final objective of avoiding the     infection, it has been suggested to use antiretroviral therapy. This is known as     post-exposure prophylaxis (PEP).      Although there are different recommendations, almost every guideline recommend using 3 drugs     as PEP both in USA and Europe.      Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are     attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.      A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus     the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases), with a     10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul     be an adequate drug for PEP.   "
133824|NCT01533259|"     This study will evaluate the efficacy of Stribild®     (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF))     single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus     Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in     virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety,     tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.   "
133825|NCT01533246|"     This phase II trial studies how well linsitinib works in treating patients with asymptomatic     or mild symptomatic metastatic prostate cancer. Linsitinib may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth.   "
133826|NCT01533233|"     The purpose of this study is to study the safety and results of thoracoscopic lobectomy using     non-intubated thoracic epidural anesthesia versus intubated general anesthesia for lung     cancer patients.   "
133828|NCT01533207|"     This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel     followed by doxorubicin hydrochloride work compared to observation in treating patients with     high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy,     such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in     different ways to stop the growth of tumor cells, either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether     combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.   "
133829|NCT01533194|"     This pilot phase I trial studies the side effects and the best dose of giving viral therapy     to patients with relapsed or refractory multiple myeloma. Viral therapy, such as wild-type     reovirus, may be able to kill cancer cells without damaging normal cells.   "
133830|NCT01533181|"     The purpose of this study is to evaluate how OSI-906 compares to Topotecan in trying to slow     down the growth and/or progression of the tumors of participants with relapsed or recurrent     Small Cell Lung Cancer.      This study also plans to find out what effects, good or bad (side effects), OSI-906 has on     participants and or Small Cell Lung Cancer. The study will also investigate if some proteins     measured in the blood or tumor and some imaging features obtained from computed tomography     (CT) scans can help predict whether OSI-906 or topotecan will be effective against Small Cell     Lung Cancer.   "
133831|NCT01533168|"     RATIONALE: Testing for minimal residual disease in cell samples from patients with acute     lymphoblastic leukemia may help doctors plan better treatment.      PURPOSE: This research trial studies a genetic test in identifying previously undetectable     minimal residual disease in cell samples from younger patients with acute lymphoblastic     leukemia.   "
133832|NCT01533155|"     Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics     of NKTR-118   "
133852|NCT01532882|"     Diosmin has a well established use status in improvement of the symptoms of venolymphatic     insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of     capillary fragility.      Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo,     to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).      The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600     mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre,     controlled, randomised, double blind, placebo-controlled, parallel-group study.   "
133833|NCT01533142|"     Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is     now an established treatment at several other hospitals in the health region (Voss Hospital     (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse     Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund:     gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion     with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in     Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from     different surgical methods.      This project is part of the regional strategic research initiative in the Helse Vest   "
133834|NCT01533129|"     The study searched for answers to two questions        1. What is the effect of testosterone replacement therapy on endothelial dysfunction,          inflammation and insulin resistance?        2. Regarding the above parameters, is there any difference between daily transdermal          testosterone implementation and intramuscular injection performed in three weeks.   "
133835|NCT01533116|"     To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa     pharmacokinetics   "
133836|NCT01533090|"     The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the     procedure is safe and effective. It has been the standard cleansing regimen for the last 25     years. To overcome the difficulty in completing the bowel preparation due to large volume     and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been     shown to provide adequate colon cleansing and better tolerability.      LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with     bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing     prior to colonoscopy thanks to the reduced volume and improved taste. The present study is     intended to compare the new dosing regimen of the bowel lavage solution given the same day     compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.   "
133837|NCT01533077|"     To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA     9-1067 or 1 hour after.   "
133838|NCT01533064|"     Objective: Reports have described how hospitalized psychiatric patients respond to disasters;     however, few reports have described the response to disaster among psychiatric outpatients,     who have relatively mild disease in comparison with hospitalized, severely ill psychiatric     patients. Here the investigators have analyzed the response to disaster among this     under-studied population.      Method: The Great East Japan Earthquake on March 11, 2011, was a catastrophic disaster. The     investigators studied psychiatric change among a population of psychiatric outpatients in     Tochigi prefecture, located ~160 km (~100 miles) southeast of the Fukushima nuclear power     plant, in an area that suffered moderate damage from the earthquake. A total of 328     psychiatric outpatients were enrolled and were grouped into the diagnostic categories F2     (schizophrenic, schizotypal, and delusional disorders), F3 (affective disorders), and F4     (neurotic, stress-related, and somatoform disorders). All diagnoses were made using     International Classification of Diseases (ICD) 10 criteria. Changes in symptoms were measured     as a change in psychotropic medication after the disaster.   "
133839|NCT01533051|"     The aim of this study is to investigate the off-treatment sustained virological and     biochemical response in chronic hepatitis B patients following the guideline by the Asian     Pacific Association for the Study of the Liver (APASL) in Korea.   "
133840|NCT01533038|"     The purpose of this study is to compare the UroLift System Treatment to Transurethral     Resection of the Prostate (TURP) in improving a patient's overall quality of life, while     evaluating healthcare expenditures associated with each therapy.   "
133841|NCT01533025|"     The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles     allograft are comparable to those using Achilles allograft with bone block on its end.   "
133843|NCT01532999|"     Currently, veterans with posttraumatic stress disorder (PTSD) are typically treated with     antidepressants which have limited efficacy and yield extremely low remission rates. New and     improved treatments are sorely needed, especially in light of the inadequate evidence to     support the efficacy of most pharmacologic and most psychotherapy treatments for PTSD.     Complementary and Alternative Medicine practices, such as meditation, may fill this void.     Several other illnesses often found in association with PTSD, such as chronic pain, anxiety,     and depression, have shown positive response to meditation, specifically Mindfulness Based     Stress Reduction (MBSR). MBSR is manualized program involving 8 weekly classes and a single     6-hour silent retreat session based on a systematic procedure to develop enhanced     non-reactive awareness of the moment-to-moment experience of perceptible mental processes.     MBSR is well tolerated, already well disseminated. MBSR has been shown to be effective in     reducing conditions that are commonly associated with PTSD, including pain, depression,     anxiety and panic, and insomnia. The investigators are conducting a multisite study of     Mindfulness Based Stress Reduction (MBSR) compared to Present Centered Group Therapy (PCGT)     for the treatment of PTSD. The primary aim of this study will be to determine how well the     MBSR form of meditation, i.e. MBSR, works to treat symptoms of PTSD in veterans compared to     PCGT. The investigators will evaluate the effects of treatment on levels of mindfulness,     depression, PTSD symptom clusters, and response rates. The investigators will evaluate     veterans' satisfaction and acceptability of the MBSR intervention. Additionally, biomarkers     will be utilized to aid in our understanding of the pathophysiology of meditation and explore     the relationship between treatment outcome and neuroimmune response.   "
133853|NCT01532869|"     This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study     will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with     systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162     mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants     will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on     study treatment is 96 weeks.   "
133877|NCT01532531|"     Collateral meridian therapy (CMT) is a recently developed technique according to traditional     Chinese medicine (TCM) experiences, differing from traditional Chinese acupuncture in     numerous manners. CMT involves the manipulation of a distant non-painful collateral meridian,     thereby facilitating the dissipation of pain. The technique avoids direct stimulation of the     involved meridian, which enhances patient tolerability and prevents further injury to the     disease and painful areas. Numerous clinical cases have reported the effectiveness of CMT in     pain management. This study tests whether CMT is effective for treating knee OA pain and     functional recovery.   "
133844|NCT01532986|"     Health care benefits and services are received through the Veterans Health Administration     (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans     across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a     chronic condition that affects motor function as well as cognition, mood, sleep, and     autonomic function. There are not enough subspecialists to manage every Veteran with     Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates     using needs assessments, evidence-based protocols, and VHA and community access coordination     mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease     care and patient-centered outcomes. If efficacious, this model may be practical to     disseminate via an existing VHA national consortium network for Parkinson's disease.      Objectives are (1) to implement then analyze via a randomized controlled trial whether a     nurse-led, coordinated care management intervention, Care Coordination for Health Promotion     and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence     to evidence-based practice guidelines and improve health outcomes in Veterans with     Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of     implementation of the CHAPS intervention and its costs to determine how the intervention can     be made sustainable and disseminated throughout Veterans Affairs Medical Centers if     efficacious.   "
133845|NCT01532973|"     The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics     of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts     to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II     will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected     participants. All parts may run concurrently, or Parts II and III may be staggered.      Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in     HCV-infected participants, elbasvir administered for 5 consecutive days has superior     antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by     change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour     postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).      Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants,     the mean maximum reduction in HCV viral load is greater following multiple dose oral     administration of elbasvir as compared to placebo.      Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in     HCV-infected participants, elbasvir administered for 5 consecutive days has superior     antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by     change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose     timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).   "
133846|NCT01532960|"     Despite advances in surgical, radiation and medical therapies of early stage breast cancer,     some patients will experience disease recurrence. Because recurrence may not happen for years     after definitive treatment, there is a period of time between resection and relapse when     micrometastatic disease may be amenable to immune eradication or modulation. While the     ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast     immunotherapy is to define treatments that have immunologic efficacy. In this study, the     investigators will determine whether a vaccine consisting of nine-class I breast specific     peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with     poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.   "
133847|NCT01532947|"     This in vivo study examined the contribution of remaining coronal dentin and placement of a     prefabricated or customized fiber post to the six-year survival of endodontically treated     premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic     treatment. Groups were classified according to the number of remaining coronal walls before     abutment build-up. Within each group, teeth were allocated to three subgroups: A) no     post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression     analysis was applied to assess whether the amount of residual coronal dentin and the type of     endocanalar retention had a significant influence on failure risk of the restored teeth.   "
133848|NCT01532934|"     Substance use among criminal offenders constitutes a major public health problem and is tied     to negative consequences for offenders, their families, and their communities. One of the     direst of these consequences is repeated incarceration; thus, interventions that reduce     criminal recidivism are needed. Forensic populations are often viewed with considerable     therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and     the assessment of individual differences among offenders may provide valuable information     that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has     emerged as an important personality construct for the understanding of violence and criminal     recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and     lack of remorse may have negative implications for the efficacy of psychosocial     interventions. A foundational premise of the present work is that understanding the     moderating role of psychopathic traits on substance use treatment outcomes among offenders is     essential to determining what works, and for whom. The current proposal is a Phase II     randomized clinical trial that aims to examine the impact of psychopathic traits on the     efficacy of a brief substance use intervention for offenders in a jail diversion program.     Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based     treatment will reduce substance use and related consequences relative to a Standard Care only     condition, 2) that the reduction in substance use in the intervention group will mediate a     reduction in later criminal recidivism relative to the Standard Care condition, and 3) that     core psychopathic traits will moderate the efficacy of the intervention such that individuals     with lower levels of these traits will derive greater benefits with regard to decreased     substance use, decreased drug use consequences, and decreased criminal recidivism at a     one-year follow-up.   "
133849|NCT01532921|"     Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in     order to position this product on the market, a post-market release study was completed. The     purpose of this study was to evaluate the hemodynamic performance of the Contour 3D®     Tricuspid Annuloplasty Ring following Tricuspid Valve repair in a post-market environment.   "
133850|NCT01532908|"     The purpose of this study is to assess efficacy of a human monoclonal antibody against     Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or     sofosbuvir [part 2: an HCV NS5B polymerase inhibitor] in a 56 day treatment duration in     patients undergoing liver transplantation due to chronic HCV infection. There is an option     for extended study treatment through 84 days if viral load is undetectable at day 56.   "
133851|NCT01532895|"     The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat     cancer pain in patients who have not been treated with a strong opioid.   "
134211|NCT01528137|"     This phase I trial studies how well talactoferrin works in treating patients with relapsed or     refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer.     Biological therapies, such as talactoferrin, may stimulate the immune system in different     ways and stop tumor cells from growing   "
133854|NCT01532856|"     This protocol is an international, multicenter, comparative, open and randomized study     designed to compare the safety and efficacy (in terms of response rate) from three induction     chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus     Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is     also designed to compare the safety and efficacy (in terms of duration of response) of two     maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each treatment     arm will include 100 patients and assessments and scheduled visits will be conducted in three     periods: Pre-treatment, treatment and monitoring. Security will be evaluated by monitoring     all adverse events, physical examination, vital signs and biochemical studies. Response to     treatment will be evaluated according to the EBMT21 criteria and will be assessed on day 1 of     each cycle of induction, at the end of nine cycles of induction therapy and monthly during     the first year of maintenance therapy and every 3 months thereafter.   "
133855|NCT01532843|"     Treatment with a nucleoside analogue and subsequent viral decline has shown to partially     restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies     investigating whether the effect of lowering viral load with nucleoside analogue therapy     prior to the initiation of peginterferon results in higher sustained off-treatment responses     showed contradictory findings.      The aim of this study is to investigate sustained off-treatment response to peginterferon     alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide     analogues, thereby lowering viral load   "
133856|NCT01532830|"     The purpose of this pilot study is to assess feasibility and clarify the design of future     study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or     prevention of migraine symptoms.   "
133857|NCT01532817|"     The purpose of this pilot study is to collect preliminary clinical data related to the safety     and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™     device for the relief of acute bronchoconstriction due to asthma.      Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the     study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic     settings capable of treating any potential complications of bronchoconstriction, an acute     exacerbation of asthma, and any emergencies associated with use of the investigational     device.   "
133858|NCT01532804|"     This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and     oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic     colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.   "
133859|NCT01532791|"     Carriers of the m.3242A>G mutation often have clinical symptoms which can include migraines,     seizures, strokes, hearing loss, balance issues, gastrointestinal issues, and many other     symptoms. The investigators would like to learn more about these disorders and have designed     a Natural History Study to monitor these conditions over time so that physicians and     scientists can not only understand the problems that patients have, but work on developing     treatments. The focus of the current work is to evaluate known mutation carriers of the     m.3243A>G (mitochondrial DNA) and their maternal relatives (carrier status not a requirement     for participation). Paternal relatives will serve as controls. This study involves no     treatment.   "
133860|NCT01532778|"     The perception of fat represents major scientific and nutritional issues. This research aims     to identify salivary markers that could predict and possibly explain this perception in     healthy human being. This would help to develop nutritional strategies for a more rational     consumption of fat.   "
133869|NCT01532648|"     This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as     add-on therapy to an existing oral 5-ASA regimen for the induction of remission in patients     with active, mild or moderate ulcerative colitis (UC).   "
134062|NCT01530087|"     The purpose of this study is to provide preliminary assessment of the safety and performance     of a novel barrier formulation (CASTLE) in a small population of subjects with irritated     peristomal skin.   "
133861|NCT01532765|"     Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on     the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause     symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has     been performed to remove the membranes with few complications, and surgical results are     generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM     surgery have been popularized by a number of retrospective studies and one prospective case     series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel     compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable     and transparent ILM is difficult and increases the risk of trauma to the retina. In addition,     indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM visualization,     is costly and has been shown to be toxic to the retina. The investigators study will be the     first randomized-controlled multi-centred clinical trial to compare the outcomes of ERM     surgery with and without ILM peeling. The results will help guide and standardize the     surgical treatment of macular ERM; to minimize unnecessary surgical risks, as well as to help     economize healthcare cost.   "
133862|NCT01532739|"     The purpose of this study is to investigate the feasibility and effectiveness of a cognitive     training group in individuals with Mild Cognitive Impairment, using a new paradigm that will     optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing     traditional memory training with the teaching of an empirically-supported problem-solving     approach, and (3) employing a clinically representative sample of individuals with MCI (e.g.,     not excluding those with mild affective symptoms).   "
133863|NCT01532726|"     This is a multicenter, non-interventional, prospective study. The observation period     comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with     partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that     occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of     follow-up even if the final assessment is not performed.   "
133874|NCT01532583|"     The aim of our study is to report the subjective and objective outcome of outside-in     transobturator technique (TOT) (Monarc®) in long-term follow-up.      This is a follow-up study concerning 191 patients operated on in Turku University Hospital     between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress     test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score     (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine     stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS),     a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short     versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an     absence of reoperation for SUI during the follow-up period.   "
133864|NCT01532713|"     Stellate ganglion block (SGB) is known to increase blood flow to the innervation area of the     stellate ganglion. Near infrared spectroscopy reflects changes of blood volume and allows     continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation     (rSO2). Previous studies have shown the increment of the rSO2 on the block side from the     baseline and the decrement of the rSO2 on the non-block side after SGB. Patients with     cerebral vascular disease undergoing SGB might be at risk a decrease in cerebral blood flow     in the non-block side. The investigators researched the effect of oxygen administration on     rSO2 in the non-block side using a near infrared spectroscopy after SGB. 5 L/min oxygen was     supplied via nasal cannula from 15 minutes after SGB. The rSO2 in the non-block side were     measured before SGB and 5, 10, 15, 20, 25 and 30 minutes after SGB.      The present study suggests that oxygen administration can increase the rSO2 of non-block     side. In conclusion, it is our belief that oxygen supplement is helpful to the patient with     cerebral vascular disease during SGB.   "
133865|NCT01532700|"     This is a phase 2, open-label, single institution trial of combination of intravenous (IV)     ofatumumab and oral GSK2110183 in patients with relapsed or refractory Chronic Lymphocytic     Leukemia (CLL). Patients must have received at least one prior line of therapy containing     fludarabine (single-agent or combination therapy). During the initial 6 months Treatment     Phase, ofatumumab will be administered weekly for 8 doses, then once every 4 week cycle for     an additional 4 doses (dose and schedule identical to the pivotal phase 2 trial) and     GSK2110183 will be given daily PO (Treatment Phase). There will be an initial 10 day lead-in     with GSK2110183 alone prior to initiation of ofatumumab to allow for evaluation of changes in     cell surface expression due to GSK2110183 and for GSK2110183 pharmacokinetic studies (Lead-in     Phase). The official Cycle 1 Day 1 will start on the date of first dose of ofatumumab. Cycle     duration = 4 weeks. Patients will be assessed for safety, disease assessment, response, and     survival on day 1 of each cycle during the Treatment Phase. A formal review of safety data by     the Data Safety Monitoring Board (DSMB) after the first 6 patients have completed cycle 1 of     the Treatment Phase will be performed before continuing accrual. All patients achieving SD,     PR or CR by the end of the Treatment Phase will proceed to the Maintenance Phase. Patients     with PD at any time, including by the end of Treatment Phase, will be taken off study. During     the Maintenance Phase, single-agent GSK2110183 will be administered daily for a maximum of 12     months (12 cycles). Maximum duration on any study drug is 18 months (18 cycles). During the     Follow-up Phase, patients will be assessed for safety, disease assessment, response, and     survival every 3 months through month 36 (year 3), or until subsequent CLL therapy or death,     whichever comes first. Key indications for study withdrawal are progressive disease,     intolerable toxicity, or completion of therapy   "
133866|NCT01532687|"     This randomized phase II trial studies how well gemcitabine hydrochloride works with or     without pazopanib hydrochloride in treating patients with refractory soft tissue sarcoma.     Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by     blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride is     more effective with or without pazopanib hydrochloride in treating patients with soft tissue     sarcoma.   "
133867|NCT01532674|"     The goal of this study is to determine if patients with chronic periodontitis when undergoing     with scaling and root planing (SRP) plus photodynamic therapy in comparison with SRP alone     result in improved clinical, microbiological and biochemical outcomes.   "
133868|NCT01532661|"     The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not     been proven yet in this context. A national register has been set up in France identifying     the patients which received rFVIIa.      Those patients had persistent and active bleeding after severe trauma despite surgery and/or     interventional radiology embolization.      The aim of this present study is to report the first clinical results in those situations of     patients treated with rFVIIa.   "
134086|NCT01529775|"     This study will demonstrate the benefits of platform switching design of the Osseotite dental     implant.   "
133870|NCT01532635|"     This phase II clinical trial studies how well two donors stem cell transplant work in     treating patients with high-risk hematologic malignancies. After receiving radiation to help     further treat the disease, patients receive a dose of donors' T cells. T cells can fight     infection and react against cancer cells. Two days after donors' T cells are given, patients     receive cyclophosphamide (CY) to help destroy the most active T cells that may cause tissue     damage (called graft versus host disease or GVHD). Some of the less reactive T cells are not     destroyed by CY and they remain in the patient to help fight infection. A few days after the     CY is given, patients receive donors' stem cells to help their blood counts recover. Using     two donors' stem cell transplant instead of one donor may be more effective in treating     patients with high-risk disease and may prevent the disease from coming back.   "
133871|NCT01532622|"     The purpose of this study is to determine the impact of blueberries on uric acid in patients     with hyperuricemia that are not receiving uric acid pharmacotherapy. The central hypothesis     the investigators propose is that daily blueberries added to a pre-existing diet will promote     uric acid lowering and improve quality of life without detriment to vital signs.   "
133872|NCT01532609|"     This study is an intervention pilot that integrates the current methadone maintenance     treatment (MMT) program in China with psychosocial and behavioral components in order to     address the critical link between drug use and HIV/AIDS.      The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the     intervention manuals and supporting materials, and finalized assessment measures and     implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT     clinics involving 41 service providers and 179 clients, and followed up at three, six, and     nine months.   "
133873|NCT01532596|"     The purpose of this study is to test if an 8-week mindfulness meditation training (vs a     wait-list control condition) program reduces neurobehavioral reactivity and improves affect     regulation in a sample of older adults, as measured by functional magnetic resonance imaging.     Additionally, we will examine if mindfulness meditation training reduces loneliness and     markers of chronic inflammation.   "
133875|NCT01532570|"     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650     in patients with Behcet's disease ( BD ) with special lesions after the administration of     TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to     week 46.   "
133876|NCT01532544|"     This is an investigator sponsored double-blinded, multinational, multi center, randomized     (2:1 active:placebo), placebo-controlled, phase IIa trial in severe pneumonia patients with     severe sepsis or septic shock, investigating the safety and efficacy of co-administration of     Iloprost and escalating doses of Eptifibatide for continuous intravenous infusion in totally     36 patients.   "
133878|NCT01532518|"     The present pilot study is aimed to obtain preliminary data on the effect of three ascending     oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.     In addition, the assessment of drug exposure (PK assessment) will provide additional     information on the dose-effect relationship, thus supporting the dose selection and dosing     schedule in the future studies.   "
133879|NCT01532505|"     The objective of this research is to compare the effect of a low dose Vasopressin infusion or     placebo during cardiopulmonary bypass on vasopressor requirements, hemodynamics and tissue     oxygen saturation and its recovery using tNIRS and vascular occlusion test (VOT) in elective     on pump cardiac surgery patients using a non-invasive near infrared spectrometry (NIRS)     machine. The clinical implications are that NIRS may permit earlier, non-invasive detection     of significant physiologic derangements and allow more accurate and timely titration of     medications, fluids and surgical intervention. The use of a low dose vasopressin seems to be     preventive for the incidence of observed post-cardiotomy vasodilatory shock and may improve     the function of microcirculation that will be assessed using VOT and tNIRS. Finally, it may     decrease both catecholamine dose and duration of their administration, it is considered as a     useful agent for decreasing all heir side-effects   "
133880|NCT01532492|"     Arthroscopic rotator cuff repair is described as being a successful procedure. These results     are often derived from clinical general shoulder examinations, which are then classified as     'excellent', 'good', 'fair' or 'poor'. However, the cut-off points for these classifications     vary and sometimes modified scores are used.      Arthroscopic rotator cuff repair is performed to improve quality of life. Therefore, disease     specific health-related quality of life patient-administered questionnaires are needed. The     WORC is a quality of life questionnaire designed for patients with disorders of the rotator     cuff. The score is validated for rotator cuff disease, but not for rotator cuff repair     specifically.      The aim of this study is to investigate reliability, validity and responsiveness of WORC in     patients undergoing arthroscopic rotator cuff repair.   "
133881|NCT01532479|"     The purpose of this study is to determine if Hyperbaric Oxygen (HBO) therapy improves     salivary gland function in previously head-and-neck irradiated patients. The following will     be evaluated: salivary a-amylase, IGF-1, Thrombospondin-1, and VEGF-A concentrations, resting     and stimulated salivary flow rate and pH, and salivary buffering capacity. Demographic data,     past medical/surgical histories, social history and habits, risk factors, medication list,     nutritional status, stage and location of tumor treated, dose/duration of radiation, and time     elapsed since radiation treatment will be reviewed and recorded. Subjects will complete a     quality of life questionnaire, describe (presence/absence) dry mouth symptoms prior to HBO     therapy, and provide current A1c level, or submit to a finger stick. The following groups     will be evaluated: 1. Head-and-neck irradiated subjects with ORN (indicating HBO therapy) 2.     Subjects with other conditions indicating HBO therapy (positive control), and 3.     Head-and-neck irradiated subjects without ORN (negative control). Subjects will include 78     males or females, 18 years old and over. In total, participation will last 22 weeks.   "
133882|NCT01532466|"     An intravenous bolus of fentanyl often induces a cough reflex. This study investigates     whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.   "
133883|NCT01532453|"     The purpose of this trial is to investigate the prevention of actinic keratoses and squamous     cell carcinomas by local application of MD-3511356 in comparison to standard sun protection     measures in immunosuppressed solid organ transplant recipients.   "
133884|NCT01532427|"     This is a post market surveillance registry to monitor the safety and performance of the     ALFApump system.   "
133885|NCT01532414|"     The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and     reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism     (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with     placebo. Subjects must not have previously been treated with testosterone products within the     last 6 months.   "
133886|NCT01532401|"     The primary objective of this study is to analyze the sensitivity of blood pressure to oral     salt intake. Matched male and female participants will be selected as normal weight,     overweight, and obese.      Participating subjects will have a first visit with blood pressure measurement and a blood     sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6     grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.   "
133887|NCT01532388|"     Objectives: This study compared the efficacy of eScreen in a two-armed randomized controlled     design, measuring outcomes in terms of changes in problematic drug use up to one year after     study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug     use offers self-screening, in-depth self-reporting, personalized feedback and treatment     recommendations as well as an electronic diary. Progress over time is shown in diagrams     detailing consumption levels.      Method: Participants with only problematic drug use according to the Drug Use Disorders     Identification Test (DUDIT),(DUDIT >0 for both men and women) or both problematic alcohol use     according to the Alcohol Use Disorders Identification Test (AUDIT), (AUDIT >7 for men and     AUDIT >5 for women) and drug use were randomized to T1 (n=101) or the control group (n=101).     Outcomes on alcohol and/or drug use as well as health-related symptoms were assessed after 3,     6 and 12 months.      Hypotheses that were tested in this study are 1) that both groups would reduce their drug     consumption and drug-related problems at follow-ups compared to the baseline level and 2)     that participants in the eScreen group would reduce their drug consumption and drug-related     problems to a higher extent than participants in the control group (no intervention) at     follow-ups.   "
133888|NCT01532375|"     With the epidemic of obesity and diabetes growing around the world, Kochujang (KCJ) may be     potentially effective in preventing and treating obesity and cardiovascular risks if proven     in humans. However, human trial still have not been reported with KCJ supplementation. In the     present study, we investigated the hypothesis that KCJ supplementation can be decrease the     body fat and improve blood lipid profiles in overweight adults.   "
134025|NCT01530568|"     Aim:      To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene     Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically     ventilated in ICU, using tracheal aspirates.      Hypothesis:      Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will     impact on rates of treatment initiation and hospital stay.   "
133889|NCT01532362|"     The primary objective for this trial is to determine the biological ability of apricoxib to     decrease T reg cells in the peripheral blood and tumor infiltrating lymphocytes in subjects     compared to those who have not in subjects with early stage Non-small Cell Lung Cancer     (NSCLC). The secondary objectives are to determine the efficacy of apricoxib to inhibit     CD4+CD25+ T reg and FOXP3 function and exploration of COX-2 dependent biomarkers of apoptosis     resistance, angiogenesis, invasion, and immunity.   "
133890|NCT01532349|"     This research is being done to study the effectiveness of vitamin D (cholecalciferol) to     modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common     problem in children with CKD. Anemia is when the body does not have enough healthy red blood     cells. Hepcidin is a protein in the blood which interferes with the body's production of red     blood cells. This study will see if vitamin D lowers hepcidin levels in children and young     adults with CKD. If so, it could be used as an additional treatment for anemia in these     children, in addition to the current therapies already in use including iron supplements and     erythropoietin. People between the ages of 1 and 21 with CKD may be considered for this     study.   "
133891|NCT01532336|"     The purpose of this study is to evaluate the clinical and microbiological efficacy and safety     of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of     age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a     positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening,     Inc).      Subjects will be randomly assigned to receive either NVC-422 or Vehicle.   "
133892|NCT01532323|"     In Human, the oral sphere is the first and main place where sensory stimuli are received and     perceived. The phenomena occuring during food breakdown and sensory perception are complex     and in this system saliva plays a major role.      In the neonatal period, severe digestive diseases require the cessation of all oral feeding     and the use of enteral or parenteral nutrition for prolonged periods to ensure the growth and     development of children while their disease is active. The early stages of sensory oral     exposures and their consequences on the development of eating habits of these children are     poorly documented. It is likely that the process of acquisition of preferences and eating     habits is atypical because of a bypass of the oral sphere during the early stages of     feeding. Thus, if not orally fed, children do not get exposed to a wide variety of tastes and     textures in the first year of life, which may impact on their oral acceptance at a later age.     These oral disorders (OD) are expressed by a refusal to eat, a heightened gag reflex, a     refusal of certain consistencies and difficulties in chewing and swallowing. Few data are     available on food typically accepted by these children.      Finally, oral sensory phenotypes of OD children (gustatory sensitivity ...) have not been     described yet. It is likely that they may differ significantly from those of healthy (NOD).      In this context, a population of OD children is particularly interesting for studying the     effects of the absence of these learning stages and their consequences in the development of     sensory perception and eating habits.      The investigators formulate the hypothesis that the lack of exposure to a standard oral diet     would modify the development of their oro-sensory systems including saliva.      Studying such a population is a great opportunity to assess the influence of non oral food     exposures and diet on saliva characteristics.      Saliva has recently received attention as a potential easy to collect source of biomarkers in     several conditions excluding OD.      The potential impact of OD on salivary composition has never been studied. Several studies     linking saliva and perception or preferences have been conducted in the UMR CSGA (Unité Mixte     de Recherche du Centre des Sciences du Goût et de l'Alimentation). They have already     contributed to highlight the great inter-individual variability for a number of saliva     markers and a change in saliva protein profiles in response to taste stimulation They also     underlined the remarkable intra-stability for saliva flow and composition during a one year     study.      This study intends to prove the concept that it is relevant to relate saliva characteristics     to food intake behaviour or food habits The first hypothesis to be tested in this study is     that salivary profiles (biological signatures) can discriminate two groups of children     differing by their orality.      The second hypothesis to be tested is that these specific biological biological signatures     may be correlated to certain food habits associated or not with oral disorders.   "
133905|NCT01532154|"     This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with     multiple sclerosis who have been exposed to prolonged-release fampridine since the first day     of their last menstrual period prior to conception or at any time during pregnancy.   "
133906|NCT01532141|"     The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067     pharmacokinetics in healthy subjects.   "
133893|NCT01532310|"     This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and     pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who     have received commercially supplied belimumab within the 4 months prior to and/or during     pregnancy. The registry will also evaluate outcomes of infants born to mothers who were     exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will     add to the current clinical experience with belimumab and will complement reproductive data     from animal toxicology studies. It will also assist clinicians in weighing the potential     risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline     (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing     Authorization.   "
133894|NCT01532297|"     Study investigating the safety and efficacy of the citrate dialysis solution compared to     standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a     clinically relevant development of adverse events. It is hypothesized that citrate dialysate     may provide a local anticoagulation effect in the dialyser improving removal of uremic     toxins.   "
133895|NCT01532284|"     A pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat     analysis, of the use of preimplantation genetic screening (PGS) for aneuploidy by means of     microarray comparative genomic hybridization (CGH) for the chromosomal analysis of the polar     bodies (PB) of oocytes collected after ovarian stimulation for in vitro fertilization (IVF),     and with the intention to assess the genetic competence of oocytes of advanced biological     age, and the effect of this technique on reproductive outcome.   "
133896|NCT01532271|"     The use of Event Related Potentials (ERP) and neurocognitive performance in patients     following concussion has been examined previously in small cohorts and relatively long after     concussion occurred. However, little is known about the immediate changes in brain activity     in specific brain regions and connectivity across them associated with performance on     specific neurocognitive tests following a concussion, and the subsequent changes over time.     The proposed study will provide initial evidence for the feasibility of an ERP based     biomarker for concussion reflecting temporal and spatial changes in brain activity as well as     brain functional connectivity associated with concussion.   "
133897|NCT01532258|"     This research is examining whether an 8-week online nutritional programming based on a     Mediterranean diet can achieve meaningful increase intake of a Mediterranean based diet and     improvements in measures of body weight and laboratory measures of oxidative stress, a risk     marker for cardiovascular disease. This study will also examine whether weekly short support     and communication from a medical assistant (MA) in a primary care setting in addition to the     online program will result in better program adherence and have a positive impact on health.   "
133995|NCT01530971|"     Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean     section under spinal anesthesia. However, evidences supporting the practice is not clear     nowadays, especially for healthy parturients who are monitored continuously with pulse     oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and     newborns.      Changing practice is not that easy. This study has been conducted to prove that supplemental     oxygen is not necessary for healthy parturients during cesarean section.   "
133898|NCT01532245|"     One method for treating intraoperative hypoxia during one-lung ventilation (OLV) is     application of PEEP to the dependent lung. However, only a minority of patients benefit from     this maneuver. The effect of applied PEEP on oxygenation depends on the relation between the     total end-expiratory pressure and the lower inflexion point (LIP) of pressure-volume curve     (1). LIP during OLV can be determined with super-syringe technique, but is too complicated     for routine operating room use. An alternative is the constant-flow method which is easy and     widely used in intensive care settings (2). The investigators goal was to confirm that the     constant-flow method as applied by an intensive care ventilator works during OLV.      Methods: After IRB approval and written, informed consent, data were obtained from 20     patients during OLV for thoracic surgery who were ventilated with an AVEA (VIASYS Healthcare)     critical-care ventilator. During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume     was used. During OLV, ventilation periods of ten minutes, with and without 5 cmH2O PEEP were     alternated. During each period, the investigators recorded arterial blood partial pressures,     respiratory and hemodynamic values, intrinsic PEEP (PEEPi), and LIP. PEEPi and LIP were     determined using the automatic mode of the ventilator; specifically, LIP was determined with     a continuous flow of 3L/minute.   "
133899|NCT01532232|"     Breast cancer patients who smoke, are at greater risk for treatment complications. The     purpose of this study is to see if the researchers can find ways to help patients who have     breast cancer quit smoking. They will compare two ways to help people quit smoking. Some     patients will receive varenicline, a prescription medicine also known as Chantix,®. Other     patients will receive a placebo drug. A placebo is an inactive substance that contains no     medicine. All patients will receive smoking cessation counseling provided by our tobacco     treatment specialists. They hope that what the researchers learn from this study will help us     improve our smoking cessation treatment program for breast cancer patients.   "
133900|NCT01532219|"     The overall aim of this study is to develop and test a psychodynamic Internet-delivered     psychological treatment for patients with major depression and/or anxiety disorders and     compare its efficacy to an active control group.   "
133901|NCT01532206|"     Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous     coronary intervention and coronary artery bypass surgery. Animal studies suggest remote     ischemic preconditioning increases levels of interleukin 10. The investigators aim to     determine whether remote ischemic preconditioning results in an increase in IL-10 levels in     patients following acute myocardial infarction.   "
133902|NCT01532193|"     This study will determine whether the use of low oxygen tension during in vitro embryo     culture may increase the pregnancy rates in women undergoing egg donation.   "
133903|NCT01532180|"     The objective of the study is to determine the safety and preliminary efficacy in patients     utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).   "
133904|NCT01532167|"     The purpose of this study is to demonstrate that [18F]FDG PET is a a better method than     clinical and laboratory values for the identification and assessment of inflammatory activity     in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise     evaluation of response to therapy.   "
133910|NCT01532089|"     This randomized phase II trial studies how well erlotinib hydrochloride (Tarceva) with or     without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung     cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     cell growth. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different     ways by targeting certain cells. Bevacizumab may also stop the growth of NSCLC by blocking     the growth of new blood vessels necessary for tumor growth. It is not yet known whether     erlotinib hydrochloride is more effective when given alone or with bevacizumab in treating     patients with NSCLC.   "
133911|NCT01532076|"     Failure rates of up to 30% are reported after proximal humeral fractures despite     angular-stable devices. This may devastate not only the functional outcome but also the     independence of elderly patients.      To increase bone mineral density and thereby holding-strength augmentation is an option.     Autologous bone-graft, as current gold-standard, though is questionable in osteoporosis since     osteoprogenitors are dysfunctional and the harvesting-morbidity considerable. Adipose tissue     seems an alternative cell-source even in presence of osteoporosis.      Stromal vascular fraction (SVF) cells isolated from lipoaspirates display osteogenic and     vasculogenic potential and can be harvested in high numbers. Expansion associated with costly     good-manufacturers-practice facilities is avoidable, so are repeated interventions. These     cells have been successfully used to generate osteogenic composite grafts with intrinsic     vascularity in preclinical models.      For translation into clinical practice after a 20 patient external pilot a prospective     randomized controlled trial with 270 patients is planned. For the trial lipoaspiration     precedes open reduction and internal fixation in individuals over 60 years presenting with a     proximal humeral fracture after low-energy trauma. Cells are isolated (Cellution®800/CRS) and     wrapped around hydroxyapatite microgranules after embedding in a fibrin-gel for augmentation     of the typical bone-void. Clinical/radiological follow-up is at 6 and 12 weeks for immediate     complications and after 6, 9 and 12 months. Functional assessment is performed after 6 weeks,     6 and 12 months using the Quick-Dash- and Constant-Score.      The primary outcome is a reduction in secondary dislocation by 50% during the first     postoperative year. Secondary dislocation is diagnosed on plain radiographs by an independent     board certified radiologist specialised in musculoskeletal imaging if one or more of the     following criteria are met:        -  More than 20° varus collapse of the humeral head fragment in relation to the humeral          shaft        -  Screw penetration through the humeral head   "
133912|NCT01532063|"     Difficult intubation is challenging in intensive care units. There are limited data regarding     risk factors of difficult intubation in ICU. The primary purpose of the investigators study     is to assess the risk factors of difficult airway in adults in ICU.   "
133913|NCT01532050|"     The present research intends to focus clinically on selecting the right type of patient for     mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging     and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy     techniques with simulation of the mandibular repositioning. The core of the research project     relies on known and established methods accepted in several neighboring fields, but aims at     the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed     biomedical research is directed towards clinical applications that incorporate innovative     developments on the level of the diagnosis and therapy of a specific disease, being     obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering     objective compliance during MAD therapy.   "
133914|NCT01532037|"     The purpose of this study is to determine if cognitive behavioural therapy (CBT) based self     help is effective for the management of symptoms of fatigue in Multiple Sclerosis (MS).   "
133915|NCT01532024|"     Seriously ill patients may develop a complication called acute lung injury (ALI), a form of     inflammation in which lung tissue is filled by fluid containing white blood cells called     neutrophils. ALI is common and is often fatal (for example in the USA it is estimated that     190,000 patients develop ALI per annum, of whom 75,000 die). No pharmacological treatment has     been shown to improve ALI.      Data from animal models and patients strongly suggest that neutrophils are central to disease     progression. However no bedside methods exist to rapidly and accurately determine in     seriously ill patients, if neutrophils are present and if they are releasing damaging enzymes     such as elastase. As such, the investigating team have developed and synthesised to clinical     grade, an imaging agent called NAP (Neutrophil Activation Probe) that detects activated     neutrophils and also the damaging enzyme, human neutrophil elastase (HNE). The investigators     have extensively tested NAP in animal models for efficacy and safety. It reliably detects     activated neutrophils and is not toxic.      NAP is a small molecule that is delivered in tiny doses (called microdoses) to areas of     inflammation in human lungs through a bronchoscope. The activity of NAP is visualised by     imaging though a tiny camera that is also introduced through the bronchoscope. This camera     system is now widely used throughout the world in over 150 sites.      The investigators therefore aim to test the utility and safety of NAP in an exploratory     clinical study. The study involves the delivery of NAP to 6 healthy volunteers followed by     delivering NAP to 3 patients in ICU with pulmonary infiltrates and 6 patients known to have     bronchiectasis.      In the healthy volunteers study, healthy male volunteers recruited from the University of     Edinburgh will be invited to participate.      In the ICU study, patients will be recruited from the ICU in the Royal Infirmary of     Edinburgh.      In the bronchiectasis study, patients will be recruited from the respiratory service in NHS     Lothian.      If the study (which is supported by the Medical Research Council) demonstrates safety and     also the ability to image activated neutrophils, the investigators intention is to design     future studies in patients with ALI.   "
133916|NCT01532011|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of erlotinib and pralatrexate that can be given to patients with advanced cancer.     The safety of the drug combination will also be studied.      Pralatrexate is designed to block the body's ability to make folic acid, a protein that may     help cancer tissue to develop and spread.      Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells     to grow. Erlotinib may help slow the growth of tumors.   "
133917|NCT01531998|"     The goal of this clinical research study is to find the highest tolerable dose of Siltuximab     that can be given in combination with Velcade (bortezomib), Revlimid (lenalidomide), and     dexamethasone to patients with MM. The safety of this drug combination will also be studied.   "
133918|NCT01531985|"     The purpose of this study is to find out whether a combination of new urine tests and blood     tests can show kidney injury in its early stages, before kidney failure sets in. If the     investigators find new tests that show kidney injury in early stages, the investigators hope     to start treating people with kidney injury earlier, to prevent kidney failure. You/your     child are at higher risk for kidney injury and kidney failure than most other people, because     of having operations with cardiopulmonary bypass (a machine that pumps your/your child's     blood during the operation). This research is being done because there are no tests yet     proven to show kidney injury before it leads to kidney failure.      The urine and blood tests the investigators are studying have each been shown to indicate     some degree of kidney injury in certain people, but not with the accuracy needed to diagnose     disease. The investigators think that the combination of urine and blood tests being tried in     this research study may provide enough information to better diagnose kidney injury at an     earlier stage.      About 20 persons over 2 years old up to adults will take part in this study. All will be from     the Herma Heart Center of Children's Hospital of Wisconsin.   "
133921|NCT01531946|"     The purpose of this study is to detect acute ischemic lesions in patients admitted with     symptoms of transient ischemic attack (TIA).      Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions     after TIA. The problem is that this only gives the diagnosis in 30% of the cases.      It is possible that the addition of Arterial spin labeling (ASL) perfusion imaging and     diffusion tensor imaging will make it possible to give a more accurate diagnosis.   "
133922|NCT01531933|"     This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12     weeks of therapy to investigate clinical efficacy and safety of DLBS3233.      It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured     by the improvement of prandial (particularly the first phase) insulin secretion as well as     insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes     into type 2 diabetes mellitus.   "
133923|NCT01531920|"     A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor     function, and cognitive effects of perampanel when administered alone and with alcohol.   "
133924|NCT01531907|"     This study has been designed to study differences bone turnover in relation to glucagon-like     peptide-2 (GLP-2) following feeding in lean and obese premenopausal women. Given the     preliminary evidence that GLP-2 may act directly on osteoclasts, the investigators plan to     determine whether GLP2 receptors are expressed in osteoclasts and the effect of GLP-2 on bone     resorption.      Hypotheses:        1. Acute responses of GLP-2 and bone resorption markers following feeding are affected by          body fat mass.        2. Serum levels of GLP-2 are lower in obese pre-menopausal women and are associated with a          reduction in trabecular and/or cortical bone mass        3. GLP-2 has direct actions on osteoclast resorption via a functional receptor   "
133925|NCT01531894|"     GSK2110183 is an orally administered, pan-AKT kinase inhibitor that has demonstrated     nonclinical activity in hematologic as well as solid tumor cell lines and xenograft models.     In the First Time In Human (FTIH) trial, monotherapy with GSK2110183 dosed orally, once daily     has shown encouraging activity in subjects with hematologic malignancies. This multicenter,     non-randomized, open-label, treatment continuation or 'rollover' study is designed to provide     continued access to eligible subjects who have previously participated in a GSK2110183 study     (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on     behalf of GSK. Eligible subjects must be receiving clinical benefit from continued treatment     and have an acceptable safety profile with GSK2110183. Subjects who have participated in a     GSK2110183 combination study with an approved anti-cancer agent will also be eligible to     enroll in this rollover study. Subjects who participated in combination studies with two     investigational compounds (one being GSK2110183) will not be eligible for this rollover     study. Subjects will be enrolled by cohort based on the duration and treatment received while     in their parent study. Safety assessments (physical examinations, vital sign measurements,     12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical     laboratory assessments and monitoring of adverse events) will be evaluated during this study.     Disease assessment will be performed using local standard of care imaging practices and     criteria appropriate for disease type and location.   "
133926|NCT01531881|"     This research may help dentists or surgeons to better detect areas in the mouth that are     either prone to cancer or are early cancers. The earlier the detection on cancer in the     mouth, the better the chance that treatment or prevention can be more effective.   "
133927|NCT01531868|"     Background: In a previous study, information verbally presented as relative risk (e.g. 50%     less likely) or qualitative risk (e.g. significantly less likely) resulted in many more     people (66%) choosing a surgical procedure for narrowing or artery in the neck than people     presented with absolute risk (e.g. 11% versus 5% over 5 years), annualized risk (e.g. 2%     versus 1% per year for 5 years) and event-free survival (e.g. 95% versus 89% over 5 years)     (33%).      Objectives: The purpose of this study is to determine whether the same observations are true     for information that is presented visually as a bar graph. In addition, the investigators     also seek to determine whether subjects feel that they understand the information better when     presented visually as compared with verbally.      Methods: 450 subjects will be approached in the neurology clinic as they are waiting for     their office visit. If the subject agrees to participate in this 10 minute study, they will     be taken to a quiet room where they will watch a 1 minute video on a laptop. The video will     feature an acting physician. The presenter will be the same for all experiment groups. The     presenter will describe a hypothetical medical situation in which a narrowing of one of the     carotid (neck) arteries is present. The presenter will then describe the risk of a stroke     related to that condition if the subject chooses medical therapy versus medical and surgical     therapy. The presentation of risk will vary and may be presented in one of 3 different ways     including a qualitative description, an absolute risk reduction over a fixed time period, and     a relative risk reduction. These three risk groups will be presented either verbally or     visually through bar graphs. In the visual subject groups, the presenter will be holding up a     graph and remain silent while the graph is shown. The amount of time allotted for the graph     on the video will be equal to the amount of time it takes the presenter to say the     information in the auditory subject groups. Given that there will be 2 sensory modalities     (verbal of visual) and 3 different presentation formats, there will be a total of 6 different     videos. After the video is complete, the subject will be asked to complete a 1 page survey     which will ask about the patient's age, gender, educational level, reason for the medical     visit, and final decision about choice of treatment. The subjects will also answer how well     they understood the data by making a mark on a 10 cm horizontal line.   "
133928|NCT01531855|"     The investigators hypothesise that reducing rapid-acting insulin dose after exercise will     help prevent Type 1 diabetes individuals experiencing hypoglycaemia.   "
133929|NCT01531842|"     This is a research study to evaluate the effects of repeated intravitreal injections on     bacteria around the eye.   "
133930|NCT01531829|"     In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue     plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than     the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to     reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses     RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of     the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive     PE with right ventricular dysfunction(RVD).   "
133964|NCT01531387|"     The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy     (hydroxyurea) to standard care (observation) in children with sickle cell anemia and     conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative     regimen (hydroxyurea) to be declared superior to the standard treatment regimen     (observation), the hydroxyurea-treated group must have a three-fold reduction in the     incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard     treatment arm.   "
133965|NCT01531374|"     The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve®     System in the treatment of symptomatic severe aortic stenosis in subjects who have a     predicted very high risk and high risk for aortic valve surgery.   "
133931|NCT01531816|"     Critically ill patients are often confined to bedrest, because of the nature of their     illness. However, it has now been shown that prolonged bedrest and immobility, particularly     in critically ill adults and children, can lead to serious outcomes such as muscle weakness     and prolonged stay in the intensive care unit (ICU). Research in adults has demonstrated that     preventing immobility and introducing exercise and rehabilitation in adult patients early     during their ICU illness can prevent these serious outcomes, reduce the duration of hospital     stay, and enhance their recovery after they leave the ICU. The purpose of our research is to     investigate if early mobilization and rehabilitation can also be performed in critically ill     children, and eventually evaluate this results in beneficial outcomes in these children, as     it has been shown to be in adults. However, given that children are not the same as adults,     but have varying abilities to understand and participate in activities when they are sick,     the investigators first have to evaluate the most appropriate and safe ways of helping     children exercise while they are in the ICU. This objective of this study is to evaluate if     2 methods of rehabilitation (a stationary bike and interactive video game) can be implemented     in critically ill children. These methods have been used in hospitalized children and in     critically ill adults. The investigators will evaluate if these methods are safe for     critically ill children.   "
133932|NCT01531803|"     This is a randomized, controlled, open-label clinical trial to be conducted at approximately     12 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of     22 months, with 6 months for trial set-up, 12 months of simultaneous subject enrollment and     30 days of treatment/follow-up period, and 3 months for study close-out.      The study population will consist of at least 60 male and female pediatric subjects between 0     days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery     with an approximately equal number of subjects (n=10 to 25) in three of the four age groups:     (29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts.      Regarding the youngest age group of 0 to 28 days, the minimum number of patients to be     enrolled in the study will not be predefined as very a small number of elective surgical     procedures is expected in this population.      Safety concerns and eventual safety signals, as well as recruitment rate, will be monitored     annually (starting from the enrollment of the 60th subject) by an independent Safety     Monitoring Board (SMB), which will be appointed prior to study initiation and submitted to     the FDA. The responsibilities of the SMB will be defined in ad hoc document, in which the     threshold for acceptable safety will also be set.      During the conduct of the study on the first 60 patients, if there is any safety signal     linked to the primary safety endpoint (i.e. pulmonary fluid overload) or imbalance in the     incidence of AEs between the treatment and control groups or based on relevant literature, as     judged by the SMB, the enrolment will be increased to 100 patients using the same age     stratification approach defined above (n=20 to 30 in each age group).      Potential subjects will be pre-screened and informed consent/assent will be obtained from the     subject and/or subject's parents or guardians prior to surgery. Post-surgery, the subject     will be admitted to the Surgical, Neonatal, or Pediatric Intensive Care Unit (SICU/NICU/PICU)     for postoperative recovery and care management. Subjects who show signs of hypovolemia as     judged by the Principal Investigator (PI) will be screened to determine their eligibility to     participate in this trial. Subjects will then be randomized to receive treatment with     Kedbumin 25% or the comparator, normal saline (sodium chloride 0.9%).      There is no specific post-treatment regimen for this protocol, as all subjects will receive     the standard post-operative care based on their clinical status and response to treatment at     the discretion of the Investigator.      Vital signs and fluid management/replacement therapy recorded in the medical chart and     results of standard complete blood count (CBC), biochemistry, and hematology and coagulation     lab panels will be reviewed and recorded by research staff at specified time points,     according to the hospital standard of care. Additionally, research staff will review and     record daily lactate, urine albumin, blood urea nitrogen (BUN), creatinine, and non-invasive     measurements at the following time points: Baseline, 6hr, 12hr, 24hr, 36hr, 48hr, and 72hr     post-onset of hypovolemia), until hemodynamic stability is achieved. Hemodynamic stability     will be evaluated based on site-specific age-defined reference ranges for heart rate, blood     pressure, urine output, and cardiac index in children.      The volume, rate and frequency of the Investigational Medicinal Product (IMP, either Kedbumin     25% or normal saline) administered will be recorded in addition to the type, timing, and     amount of all other fluids administered. The time to hemodynamic stability, duration of     stability once attained, and any relapse requiring additional treatment or use of secondary     resuscitation strategies will be recorded. Subjects who demonstrate hemodynamic stability     within 3 days after treatment initiation and then relapse into hemodynamic instability as a     result of surgical complications or infection will exit from the study, but the data be     considered for the safety analysis. These subjects should continue treatment according the     clinical practice standard since the study is not intended to evaluate the efficacy of     Kedbumin 25%.   "
133933|NCT01531790|"     This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of     continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced     non small cell lung cancer (NSCLC) patients.   "
133934|NCT01531777|"     RATIONALE:      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The     investigators' phase I study has shown that the drug's toxicity is manageable.      PURPOSE:        1. Studying how well Apatinib works in treating patients.        2. Finding the efficacy and safety of 500 mg or 750mg Apatinib.        3. Pharmacokinetics/Pharmacodynamics(PK/PD).        4. Exploring new outcome measures of antiangiogenic drugs.   "
133996|NCT01530958|"     The purpose of this study is to evaluate the feasibility and acceptability of two different     interventions aimed at improving health outcomes among patients with chronic kidney disease     (CKD), who are at high risk of CKD progression. Specifically, this study will examine how     best to implement a provider-level intervention (access to a CKD-registry) and a     patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on     patient health outcomes, with a 2x2 factorial design.   "
133935|NCT01531764|"     This open-label, single-arm, multicentre phase II trial will be performed in patients with     intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and     one first-line therapy in the metastatic setting.      The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in     combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial     shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination     with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are     warranted.      Patients will be followed until progression. After progression, for the purpose of analysing     overall survival, information on vital status and subsequent treatment will be collected.      The primary objective is to determine the 6-month progression free survival rate of BIBW 2992     and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast     cancer.      BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the     hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by     immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit     from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible     EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.   "
133936|NCT01531751|"     The aim of the study is to assess survival of patients with advanced cardiac AL amyloidosis     treated with high cut-off hemodialysis (HCO-HD) combined with chemotherapy.   "
133937|NCT01531738|"     The investigators hypothesize that some of these changes in the reduced appetite after     surgery may be due to alterations in taste. The aim is to compare obese patients before and     after bariatric surgery (gastric bypass and banding) to define the reward value of sweet,     fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.   "
133938|NCT01531725|"     The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK     PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary     arteries.   "
133939|NCT01531712|"     Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by     chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with     borderline resectability. The primary objective is to determine the resectability rate of     patients with pancreas adenocarcinoma with borderline resectability determined     radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy     with Gemcitabine and Tarceva.   "
133940|NCT01531699|"     This is an open-label, randomized, single-dose, placebo-controlled efficacy study to assess     the antimicrobial efficacy of ALT005 ophthalmic prep solution following dermal administration     in healthy volunteers. Efficacy will be assessed by comparing the reduction in microbial load     for up to 6 hours to that of saline control.   "
133941|NCT01531686|"     Intraosseous vascular access can be used to effectively and safely deliver contrast dye for     CT examination.   "
133942|NCT01531673|"     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and     pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in     subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation.   "
133943|NCT01531660|"     Background: Inactive individuals face motivational obstacles for becoming and staying     physically active. Therefore, sustainable physical activity promotion programs tailored to     reach inactive individuals are needed.      Purpose: to test the effect (long and short-term) and feasibility of a training program and     to evaluate the association between the baseline motivation to become physical activity and     the change in physical activity and performance.      Design: uncontrolled trail Setting/participants: inactive, female hospital staff aged 45 and     older from the University Hospital Zurich Intervention: 3-month step-up jogging program Main     outcome measures: physical performance and level of physical activity   "
133945|NCT01531634|"     The field of psychiatric rehabilitation focuses on creating a personal narrative and     developing coping strategies and environmental supports. The concept of recovery is     person-centered and emphasizes the person's ability to change and to live meaningful life.     The strengths approach has a central role in the recovery concept, emphasizing the person's     abilities and potential. A preserved cognitive ability can be a significant strength in the     recovery process.      Research had shown growing support for the use of cognitive-behavioral approaches as the most     effective therapy for people with borderline personality disorder, using structured     interventions. A central focus in cognitive therapy is the change of maladaptive schemes. The     dynamic-cognitive intervention (DCI) is based on the understanding of structural cognitive     modifiability and suggests the use of mediated learning in order to enhance sense of     competence and develop better psychological coping skills.      The present study will focus on women diagnosed with borderline personality disorder, with     normative cognitive ability seen as a strength as opposed to their emotional ability. This     study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and     on symptoms severity.      The study will include 30 women aged 18-45 years. Participants will be randomly assigned to     an intervention group and a control group. All participants will be assessed before and after     intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom Inventory.      The intervention designed for this study is based on the principles of the Dynamic Cognitive     Intervention. The intervention tools that will be used include: a. Instrumental Enrichment     tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The     intervention encompasses 12 sessions of 1.5 hours, with a routine structure.      The results are expected to contribute to the understanding of the impact of a dynamic     cognitive intervention in women diagnosed with borderline personality disorder.   "
133946|NCT01531621|"     -  A population-based prospective study to evaluate clinical behaviour, resectability and          survival in 1st line metastatic colorectal cancer (CRC) patients in Finland        -  Primary objective: To assess clinical behaviour of metastatic colorectal cancer and          overall resectability, postoperative morbidity and outcomes after resection        -  Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy          and targeted drugs with overall response rates (ORR), failure free survival (FFS),          progression free survival (PFS), and overall survival (OS); To radiologically assess          tumour density and morphology, and assess alternative radiologic response evaluation in          comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and          tumour block biomarkers and DNA polymorphisms that may predict drug effects,          resectability and clinical behaviour of the tumour   "
133947|NCT01531608|"     This is a single-institution study seeking to evaluate if mobile gamma camera imaging can be     used independent of standard fixed gamma camera imaging in patients undergoing sentinel node     biopsy for melanoma.   "
133948|NCT01531595|"     -  Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with          alternating Xeliri and Xelox as first-line treatment of patients with metastatic          colorectal cancer.        -  Primary objective: PFS, To assess overall resectability in patients with metastatic          colorectal cancer, postoperative morbidity and outcomes after resection.        -  Secondary objectives: To assess response rates according to RECIST criteria, failure          free survival (TTF) and overall survival (OS), Quality of life according to 15D          questionnaire, To radiologically assess tumour density and morphology, and assess          alternative radiologic response evaluation in comparison with RECIST response criteria,          Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms          that may predict drug effects, safety, resectability and clinical behaviour of the          tumour   "
133949|NCT01531582|"     There is mounting evidence to suggest that a treatment for Angelman syndrome is not just     possible, but probable. The lack of known molecular targets associated with AS has hampered     the development of specific therapeutics. However, a recent surge of potential therapeutics     for other disorders associated with cognitive disruption has begun to be used in human     clinical trials. The molecular modes of action for many of these new therapeutic agents have     correlates to counter the molecular defects observed in AS. One such agent is minocycline     (MC), a drug traditionally used as an antibiotic. This compound administered to a mouse model     of AS showed a significant decrease in motor deficit and an increase in long term     potentiation. The investigators believe a similar result will be observed when minocycline is     administered to the AS patient and may lead to the development of an effective AS     therapeutic.   "
133950|NCT01531569|"     This study is being done to look at age differences in the way the investigators bodies break     down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is     administered to research subjects in a product called BeneFlax, which a concentrated version     of flax seed containing 38% SDG.      It is known that as people age, their bodies undergo physical changes both on the outside and     the inside. The aging process may change the way that the investigators bodies deal with     compounds the investigators eat. As an important measure of safety, the investigators want to     check for evidence whether there is a difference in break down of SDG between different age     groups.   "
133951|NCT01531556|"     Honey available in New Zealand can contain the toxins tutin and hyenanchin. Tutin is produced     by several plants native to New Zealand. Bees collect honeydew contaminated with tutin and     hyenanchin for honey production.      Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand     since the 1800s, with the most recent outbreak in 2008.      The study aims to find out how tutin and hyenanchin are absorbed and processed by the body.     This information will help the Food Standards Australia New Zealand (FSANZ) give guidance on     acceptable levels of tutin and hyenanchin in honey.      About 6 healthy men will each take a single dose of honey containing known concentrations of     tutin and hyenanchin.      This dose level is similar to what someone who eats a lot of honey would consume, if the     honey contained the maximum level of tutin allowed under the Food Standards Code.      Blood tests to measure tutin and hyenanchin levels will be taken at certain times after     dosing, and any side effects will be recorded.   "
133966|NCT01531361|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of ZelborafTM (vemurafenib) with Nexavar® (sorafenib) or Xalkori® (crizotinib)     that can be given to patients with advanced cancer. The safety of these drugs will also be     studied.      Vemurafenib is designed to block a protein called BRAFV600E inside the cancer cells, which is     involved in cancer cell growth.      Sorafenib is designed to block the function of important proteins in and outside of cancer     cells. These proteins are involved in cancer cells growth and new blood vessel development.      Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause     the cancer cells to die.   "
133967|NCT01531348|"     The purpose of this study is to determine the feasibility and safety of adult human bone     marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis     pigmentosa.   "
134087|NCT01529762|"     Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.   "
133952|NCT01531543|"     The aim of the project was to optimalize the process in severe peritonitis which is generally     inflicted with high mortality and morbidity with long term costly therapy. Therapy of severe     intraabdominal infection consist of treatment of the infection site and following closure of     the abdominal cavity with possibility of re-laparotomy and in treatment of complications when     needed; or closure introduction of laparostomy with intention to control complications     prevention however with risk of tertiary peritonitis. Modern process is laparostomy with     active suction (VAC) method which reduces the risk of tertiary peritonitis. It efficacy is     however approved especially in therapy of complications. Based on the investigators     experiences the investigators use this method even in case of primary treatment of severe     peritonitis which led to protocol processing (VAC in case of primary closure of the abdominal     cavity; VAC exchange according to scoring system; secondary closure of the abdominal cavity     or early coverage with collagen mesh). The aim of this project is to prove reduced mortality,     morbidity and hospitalization length (cost reduction) in prospective randomized study in     patients treated due to severe peritonitis using VAC method in comparison to classical     approach (primary closure of the abdominal cavity; secondary solution of complications).   "
133953|NCT01531530|"     The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral     vaccine) is safe and effective in the prevention of Shigella infection.   "
133954|NCT01531517|"     Clinical Trial Phase III-b      Study Sponsor:      European Egyptian Pharmaceutical Industries      Sample Size:      120 patients (60 per arm)      Study Population:      Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed.     Those patients will be recruited from patients attending the Diabetic foot Center at Faculty     of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo     University.      Recruitment Period: 9 months      Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the     ulcer.      Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever     comes first   "
133955|NCT01531504|"     Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites   "
133956|NCT01531491|"     Hypercapnia derives increase of cerebral blood flow and cardiac output. It means that the     rate of propofol elimination from the brain and the blood will be increased and the patient     will awake more quickly. There has been no study about the effects of hypercapnia. The     investigators will evaluate hypercapnia's effects on the recovery time from propofol     anesthesia.   "
133997|NCT01530945|"     Patients with end-stage kidney disease (ESKD) must manage not only the demands of dialysis     and comorbid conditions but also associated symptoms and acute life-threatening events that     contribute to functional limitations and increased risk of mortality. Yet little is known     about the trajectories of quality of life dimensions in patients with ESKD when they     experience acute life-threatening episodes, to guide palliative care for this population. In     this prospective, descriptive study, we will identify trajectories of symptoms, physical     functioning, psychosocial needs, and emotional and spiritual well-being in 200 patients with     ESKD who are at a high risk of experiencing acute life-threatening events and mortality     within 12 months.   "
133957|NCT01531478|"     Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of     850 French persons has survived childhood cancer. However, the complications of chemotherapy,     radiotherapy or surgery can lead to a higher risk of secondary mortality, which the     literature estimates is at 14%. Regular care has a positive impact on the quality of life and     health of adults who survived cancer during their childhoods. It aims to detect the potential     long-lasting effects of cancer and to provide therapeutic education and psychological care.     Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands)     have developed long-term care structures which function with specially trained adult medicine     practitioners. There are only two structures in France: the Long-Term Oncology/Hematology     Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the     follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France,     which began in 2003 and has since been extended to other centers.      The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they     compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary     trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed     the correlation between patients' quality of life and the long-term medical effect of cancer     and treatment, both recorded in patients' medical files and declared by patients. These young     adults who survived pediatric cancer appear to suffer from and declare many complications,     although this does not impact their global quality of life much. There is a negative     correlation between the number of complications (observed or declared) and the global quality     of life score, but only three types of complications play a significant role (motor function     complications, auditory complications, and alopecia.) In addition, there is a significant     mismatch between patients's perceived health (what they say they experience), and the     information contained in their medical files. These young adults expressed the need for their     impressions to be better taken into account by health care professionals. This study does not     assess patients' psychopathological characteristics.   "
133958|NCT01531465|"     The purpose of this study is to compare two common methods of providing respiratory support:     nasal continuous airway pressure and high flow nasal cannula to see what effect it has on     babies breathing. The investigators also will compare the effects of slightly changing the     level of support these two different types of therapy on how easily your baby is breathing.     Changes in the level of support and between these two respiratory support modalities are     frequently done and are part of the routine care in the neonatal intensive care unit.   "
133959|NCT01531452|"     The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as     first-line treatment of advanced gastric cancer.   "
133960|NCT01531439|"     There will be two groups in this study: one group will be given the standard infusion of     naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the     other group will receive a higher dose. The trial is designed to determine if a higher dose     of naloxone infusion will reduce side effects from opioid therapy in patients who have     undergone spine fusion for scoliosis.   "
133961|NCT01531426|"     Data indicate that neurological prognostication is difficult after cardiac arrest if mild     therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected     by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome     assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors     with a continuously low cerebral oxygenation index have a poor prognosis.   "
133962|NCT01531413|"     Oxygen has inherent bactericidal properties. The investigators are testing to see if they can     reduce the incidence of postoperative abscesses following laparoscopic appendectomy by     insufflating with oxygen at the end of the case.   "
133963|NCT01531400|"     The investigators hypothesized that self-selected music played during electrodiagnosis is     effective in relieving the discomfort caused by the procedures.   "
133968|NCT01531335|"     The aim of this study is to compare two nutritional regimes in critically ill patients.     Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15     kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment) score.     The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic     failure in these patients.   "
133969|NCT01531322|"     This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal     Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese     adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then     infants aged approximately 2 months.   "
133970|NCT01531309|"     Agomelatine (AGO178) was developed for the treatment of depression. A new formulation is     being tested in the present study: a tablet to be placed and dissolved under the tongue     (sublingual tablet). The goal of this trial is to study the pharmacokinetics of agomelatine     given as sublingual tablet in patients with liver impairment and to compare the results to     those of healthy volunteers who receive the same treatment.   "
133971|NCT01531296|"     Determining the investigators ability to accurately assess rotational malalignment clinically     compared to imaging.   "
133972|NCT01531283|"     Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology     in healthy subjects. The proposed research is an investigator-initiated study funded by the     National Institutes of Health designed to examine the effect of physiologic levels of UAG on     the regulation of glucose homeostasis as well as beta cell function.   "
133973|NCT01531257|"     Chronic Allograft Nephropathy (CAN)/Interstitial fibrosis and Tubular Atrophy (IFTA) is     responsible for most kidney transplant failures. CAN/IFTA on a 3 month kidney biopsy strongly     predicts graft survival long term. CAN/IFTA remains a vexing problem for clinicians because     current monitoring tools, namely the serum creatinine concentration, are not sensitive to     early changes in glomerular filtration rate (GFR) or to histologic damage.      Despite advances in prevention of acute rejection (AR), it is still a significant and     potentially devastating complication of solid organ transplantation. One strategy to reduce     the risk of rejection is to perform kidney biopsies to detect subclinical acute rejection     (SCAR) and treat to prevent progression to rejection. There is evidence that treating SCAR     can prevent further immune mediated injury to the kidney, a precursor to CAN/IFTA.      Kidney biopsies provide better information but are limited due to safety concerns, patient     preference and cost issues. Better, early and less invasive markers of CAN/IFTA will allow     early intervention as well as improved graft and better patient outcomes.      This study seeks to validate specific proteogenomic biomarker panels for AR and CAN/IFTA in a     prospective blood, urine and kidney tissue monitoring study of kidney transplant recipients     who will be scheduled for standard of care biopsies.   "
133974|NCT01531244|"     This phase I/II trial studies the safety, best dose and effectiveness of targeted gene     therapy combined with isolated limb infusion (ILI) of melphalan and dactinomycin for treating     patients with advanced extremity melanoma that cannot be removed by surgery. Adding gene     therapy to a standard chemotherapy regimen in the isolated limb may enhance anti-cancer     effects by inducing a systemic immune response against the tumor cells.   "
133975|NCT01531231|"     The purpose of this study is to examine the role of every day experiences as they relate to     coronary artery disease (CAD).   "
133976|NCT01531218|"     A randomized, double-blind, placebo-controlled clinical trial of azithromycin in     Campylobacter concisus culture positive patients with diarrhea. The clinical characteristics     of emerging Campylobacter concisus in adults is vomiting and persistent diarrhea. Whether     patients may benefit from antibiotic treatment is unknown. The purpose of this trial is to     investigate whether antibiotic treatment with azithromycin of Campylobacter concisus induced     diarrhea can better the symptoms and shorten the duration of illness.   "
133977|NCT01531205|"     The aim of this study is to test whether adding chemotherapy/cabazitaxel and     hormonal/androgen deprivation therapy before surgical removal of your prostate would improve     the outcome of salvage surgery for locally recurrent prostate cancer after the initial     primary radiation therapy.   "
133978|NCT01531192|"     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal     system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida     colonization. The objective of this study is to evaluate the efficacy of prophylactic     Lactobacillus reuteri in reducing the candida colonization and infection in very low birth     weight infants.   "
133979|NCT01531179|"     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal     system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in     newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other     lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in     clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing     enterocolitis in very low birth weight infants yet. The objective of this study is to     evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence     and severity of necrotizing enterocolitis in very low birth weight infants.   "
133980|NCT01531166|"     The current proposed study aims to bring answers following issues: the antiviral efficacy and     safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with     solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or     accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease     progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more     data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in     patients with CHB.   "
133981|NCT01531153|"     Specific Aim #1: To determine if galantamine (8 or 16 mg/day) is more effective than placebo     in reducing cocaine use as measured by cocaine urine results and self-report days of use.      Specific Aim # 2: To determine if galantamine (8 or 16 mg/day) is more effective than placebo     in improving attention, assessed with the Rapid Visual Information Processing (RVIP) and the     Simple Reaction Time (SRT) tests Specific Aim # 3: To determine if improvement in attention     during the first four weeks of treatment will mediate galantamine's efficacy in reducing     cocaine use.   "
134019|NCT01530659|"     This clinical trial is a single-site, 30 patient study for participants who have early stage     retinitis pigmentosa, or Usher syndrome (type 2 or 3). Funding Source - FDA OOPD and     Foundation Fighting Blindness.   "
133982|NCT01531140|"     Background:      Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing     prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes     lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is     needed.      Aim:      The efficacy and tolerability of three different bowel cleansing protocols used in children     for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative     (bisacodyl) compared with sennosides.      Methods:      Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day or     PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days prior     to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a     blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score,     proportions of participants with excellent/good and with poor/inadequate bowel preparation),     and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy     evaluated with the visual analog scale. Analysis will be done on an intention to treat basis.   "
133983|NCT01531127|"     The purpose of this study is to determine whether there is a difference in executive function     in learning in children with ADHD receiving medical treatment alone to the executive function     in children receiving, in addition to medical treatment in learning strategies.   "
134010|NCT01530776|"     The purpose of this study is to assess the feasibility and efficacy of an     electronically-mediated, pregnancy and postpartum, behavioral intervention program, compared     to usual obstetric care, on changes in weight and cardiometabolic biomarkers among overweight     and obese Black women.   "
134011|NCT01530763|"     This is a study of safety and effectiveness of ceftaroline fosamil in children with Community     Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.   "
133984|NCT01531114|"     Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial     infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent     implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI     undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in     terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg)     in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug     administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study     drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI     with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD     administration. All patients must will be naïve for platelet P2Y12 receptor inhibition     therapy. A subanalysis will be performed between two study groups according to insulin     treatment.   "
133985|NCT01531101|"     The First Experimental Study on Transference work - In Teenagers (FEST-IT) will be a     randomized clinical trial, which will be designed to explore effects of transference work in     dynamic psychotherapy in adolescents with major depressive disorder (MDD). The design of the     study is a so-called dismantling design, in which a single component is added and/or varied     to an existent treatment method (psychodynamic psychotherapy). Thus, the efficiency of a     specific technique (transference interventions) can be identified.      The primary hypothesis is that the transference group may have a more favorable course over     time than will the comparison group.      The second hypothesis is that patients with a history of low Quality of Object Relations     score and/or personality disorders—might benefit more from therapy with transference work     than from therapy without.      The third hypothesis is that female adolescents may have better treatment effect of     transference work than male adolescents.   "
133986|NCT01531088|"     Adverse drug events (ADEs) are the most clinically significant and costly medication-related     problems in nursing homes (NH) and are associated with an estimated 93,000 deaths a year and     as much as $4 billion of excess healthcare expenditures. Current ADE detection and management     strategies that rely on pharmacist retrospective chart reviews (i.e., usual care) are     inadequate. Active medication monitoring systems are recommended by many safety organizations     as an alternative to detect and manage ADEs. These systems have been shown to be less     expensive, faster, and identify ADEs not normally detected by clinicians in the hospital     setting. The investigators developed and pilot-tested an active medication monitoring system     for use in a single NH, where it was shown to detect ADEs with a high degree of accuracy and     at a rate of nearly 2.5 times that of usual care. The long-term objective of our proposed     research is to improve patient safety with respect to medications in NHs. The short-term     objectives or specific aims of our proposed research are to determine if NH patients managed     by physicians who receive active medication monitoring alerts have more ADEs detected, have a     faster ADE management response time, and can result in more cost-savings from a societal     perspective compared to usual care.   "
133987|NCT01531075|"     The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of     IBD patients treated with immunosuppressive medications.   "
133988|NCT01531062|"     The purpose of this study is to determine whether Nigella sativa seed extracts are effective     in the treatment of dyslipidemia in elderly.   "
133989|NCT01531049|"     The purpose of this study is to assess the efficacy and effectiveness of varenicline and     nicotine patch combined with motivational interview technique in smoking cessation of young     adults over 12 months follow-up.   "
133990|NCT01531036|"     Breast Ultrasound Elastography is a complementary technique permitting a better     characterization of breast lesions. 3D breast ultrasound elastography is a novel technique     permitting a volumetric calculation of lesion stiffness. This could be particularly useful in     patients with large breast tumors under pre-operative chemotherapy   "
133991|NCT01531023|"     The prevalence of extended spectrum beta-lactamase (ESBL) producing bacteria found in urine     sample cultures has been increasing over the past decades.      The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam     treatment of ESBL producing E. coli and K. Pneumoni, as well as to observe the clinical and     microbiological outcome of the same group of bacteria treated with other antiinfectious     agents.      Samples are gathered in primary care setting.   "
134048|NCT01530269|"     Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant     metastases from prostate cancer. This clinical trial is studying how this imaging test may     help influence the choice and extent of initial treatments, and subsequent treatments.   "
133992|NCT01531010|"     Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for     preterm infants in comparison to pressure-limited ventilation. This study aims to compare     pressure-limited to VTV in preterm infants.      Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning     criteria compared to pressure-limited ventilation      Primary outcome: Time taken to achieve pre-specified weaning criteria.      Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited within     the first 24 hours of life and randomly allocated to receive either pressure-limited or VTV.     Adjustments to ventilator settings were made according to the trial protocol. Infants were     deemed to have met failure criteria if they required HFOV, required peak pressures of more     than 26 cm of water or developed pulmonary haemorrhage. Analysis will be by     intention-to-treat.   "
133993|NCT01530997|"     The purpose of this research study is to learn about the effectiveness of using     lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated     low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck.     The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment     for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is     performed afterwards. This standard regimen causes a lot of side effects and long term     complications. This study is evaluating whether a lower dose of radiation and chemotherapy     may provide a similar cure rate as the longer, more intensive standard regimen. Patients in     this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy     followed by a limited surgical evaluation.   "
133994|NCT01530984|"     This is an open-label randomized phase II study. Patients are randomized so as to achieve     uniform patient cohorts treated on each regimen. Twenty-seven patients will be required per     treatment arm, and a total of 54 prostate cancer patients will be required to complete this     study. The study will assess for clinical activity by Prostate Specific Antigen (PSA)     response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in     chemotherapy-naïve patients with metastatic castrate resistant prostate cancer.   "
133998|NCT01530932|"     Sepsis remains a common entity in critical care patients with remarkable mortality. Pulmonary     and abdominal infections (with subsequent sepsis) are the most common in the ICU. Despite     extended research activities, no differences in patient outcome or organ dysfunction were     revealed.      Sepsis is a complex immune reaction phenomenon based on unbalanced activation and     suppression. In addition to changes of cytokine levels and immune cell activity, underlying     genetic reactions are present. For instance, expression of miRNA (as a potential important     step of immune cell activation) is likely changed during systemic and local immune reactions.      The aim of this study is to perform a detailed assay of immune cell activation, to     investigate the levels of pro- and antiinflammatory cytokines and the various expression of     miRNA depending on the origin of infection in the two most common sides. This means in ICU     patients with early pulmonary or abdominal sepsis as well as in healthy controls.     Additionally, clinical parameters of organ function, current infection markers as CRP and     procalcitonin, cardiovascular function and heart rate variability will be assessed.     Parameters of local tissue perfusion in a dynamic testing during forearm ischemia and plasma     adenosine concentration will be measured.   "
133999|NCT01530919|"     The main purpose of this research study is to evaluate the effectiveness of a minimally     invasive surgical approach to removing parathyroid gland(s). The researchers are also     interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that     may contribute to overactive parathyroid gland(s).   "
134000|NCT01530906|"     Bulimia nervosa is defined by recurrent episodes of binge eating followed by compensatory     behaviors (such as induced vomiting) to prevent weight gain. It is a common and serious     disease for which current treatment strategies have to be improved.      The aim of this study is to assess whether a transcranial magnetic stimulation reduces     bulimic symptoms in a short term.   "
134001|NCT01530893|"     The primary aim of this placebo-controlled study is to determine whether flavonoids     beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated     cardiovascular risk.      The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we     will assess the effects of the food matrix, and aspects of isoflavone metabolism.   "
134002|NCT01530880|"     Fever, defined as temperature higher than 38.3C (100.9 F), is common in patients with head     injuries and is associated with poor recovery after injury. The current standard of care is     to use oral acetaminophen (Tylenol) followed by a body cooling device. This method can     effectively reduce fever but results in a high rate of shivering. Shivering is stressful to     the heart and can further worsen brain injury. Methods to combat shivering have been     developed and are successful in limiting the stress in the majority of patients that use a     body cooling device. However, the drugs used to control shivering are sedating and may also     interfere with brain recovery.      The purpose of this study is to assess whether ibuprofen given intravenously is more     effective in combating fever than the current standard of care. Should results from this     study demonstrate that ibuprofen infusion is effective, a larger study will be conducted to     determine whether this aggressive fever control regimen leads to improved recovery after     brain injury.   "
134003|NCT01530867|"     Over half of all Americans take dietary supplements (vitamins, minerals, herbal products)     along with their prescription medications. With the economic downturn, dietary supplement     sales have surged, perhaps as a result of people attempting to stave off or delay medical     care. Supplements are generally thought to be harmless, but some can potentially interact     with prescription medications, cause liver or kidney damage, and even adversely affect     surgical outcomes. Those substituting dietary supplements for prescription medications also     may suffer significant adverse consequences. The United States Food and Drug Administration     and the Institute of Medicine recommend that patients considering dietary supplement use     consult their providers. Unfortunately, patients fail to disclose dietary supplement use in     up to two-thirds of outpatient office visits. To improve discussions, it is important to     understand what prompts physicians and patients to communicate about dietary supplements.      The overall objectives of this application are to understand how, when and why physicians and     patients communicate about dietary supplements, and to assess how patients respond to these     discussions. An ethnically diverse group of patients and their physicians will be surveyed     and their office visits will be audio recorded. Audio recordings of the visits will be used     to assess the relationship of patient and physician attitudes and values, and the     physician-patient relationship on dietary supplement discussions. A subset of these patients     and physicians will be interviewed to explore how they made decisions to initiate or forgo     discussions about supplements. They also will be asked questions concerning the necessity of     and responsibility for initiating dietary supplement conversations. Patient responses and     reactions to actual discussions also will be explored. Data from observed and reported     interactions will be compared to provide a deeper understanding of factors related to     disclosure. This project aims to provide a broad understanding of the content of     physician-patient discussions about dietary supplements, and to describe how and why     physician and patient attitudes and opinions affect these discussions. Identification of     mutable factors can result in interventions to increase communication about dietary     supplements, help maintain patient safety, and promote appropriate use of supplements     concurrent with prescription medications.   "
134004|NCT01530854|"     Plasma free fatty acids (FFAs) are thought to play a role in the generation of organ     dysfunction. The investigators hypothesize that plasma FFA levels are a marker of poor     prognosis in patients with sepsis. The present study will examine the relation between plasma     FFA levels and severity of illness in patients with sepsis presenting to the Emergency     Department. It will also examine the relation between plasma FFA levels and the risk of     developing late morbidity, multiple organ dysfunction syndrome (MODS) and/or mortality during     initial hospitalization and over a 30-day follow-up period.   "
134005|NCT01530841|"     Myotonic dystrophy type 1 is a myopathy with complex respiratory pattern and at risk to     develop respiratory failure. Classical mode of ventilation are sometimes not tolerated or     ineffective in this population. New modes of nocturnal ventilation by combining both     volumetric and barometric advantages. The aim of this study is to compare effect of AVAPS     mode to bilevel pressure support.   "
134006|NCT01530828|"     This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal     perforation in infants who are at high risk. Analysis of perforation rates of all infants in     the three largest participating sites shows that the majority of infants with perforation     will do so prior to day of life 21. This study will target the group of infants at highest     risk for IP, those with birth weight less than 1000 grams, within the time frame most likely     to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate     premature infants with and without intestinal perforation in the first 3 weeks of life.   "
134007|NCT01530815|"     The investigators are testing to see if infusion of bupivicaine between the mesh and     abdominal wall can reduce postoperative pain and decrease use of narcotics in the     postoperative setting.   "
134008|NCT01530802|"     The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with     vascular clips can reduce blood loss significantly.   "
134009|NCT01530789|"     Feasibility monocentrique opened study estimating the use of an electronic personalized     educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6     months having an electronic pad.   "
134012|NCT01530750|"     Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up     to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks     before the surgery. Frequency, burden, and possible risk factors will be described.      During the operation direct contact epicardial mapping will be performed and tissue samples     will be collected to identify an electrophysiological and a structural substrate for     development of AF.   "
134013|NCT01530737|"     The primary objective of this study is:      1. To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age     undergoing cardiopulmonary bypass (CPB) for cardiac surgery      The secondary objectives of this study are:        1. To determine if the administration of AT concentrate prior to heparinization will          decrease the amount of heparin required to achieve optimal anticoagulation (as defined          by anti-Xa levels) during CPB        2. To determine if a decrease in activation and consumption of coagulation proteins,          platelets and subsequent fibrinolysis will result in improved haemostasis following CPB        3. To determine if there will be a reduction in postoperative bleeding and associated          clinical complications   "
134014|NCT01530724|"     The investigators hypothesize that differential dynamics in fat depots in response to two     opposing dietary strategies mediate the beneficial metabolic effects during weight loss and     regain phases.   "
134015|NCT01530711|"     Observe the effect of terlipressin on renal function in patients with SHR type I adjusting     the dose based on hemodynamic response.   "
134016|NCT01530698|"     Objectives: This is an exploratory study, consisting of two parts. In part I dose escalation     is performed and the primary objective is the safety of different doses of TLR-DC and Trimix     DC. In part II Trimix DC vaccination will be compared with TLR-DC vaccination and the primary     objective of this part is the immunological response, with toxicity and clinical efficacy     being secondary objectives. These studies will provide important data on the safety and     immunological effects of TLR-DC and Trimix DC.      Study design: Part I of this study is an open label dose escalation study. Part II of this     study is an open label randomized phase II study.      Study population: Our study population consists of melanoma patients, with proven expression     of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional     lymph node metastasis in whom a radical lymph node dissection is performed within 2 months of     inclusion in this study (further referred to as stage III) and melanoma patients with     measurable distant metastases (further referred to as stage IV) will be included.   "
134017|NCT01530685|"     The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary     supplement, on glycemic control of overweight prediabetic subjects.   "
134018|NCT01530672|"     This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio     Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic platform     is designed for use at point of care (POC), it is made to provide similar performance as     reference standards. Diagnosing HIV and syphilis accurately with a single POC test will save     time for clinic health workers and technicians, reduce loss-to follow-up caused by lengthy     delays for lab-based tests, and save costs by eliminating the need for multiple tests. For     this study, the sensitivity and specificity of the MBio HIV/Syphilis Serology System     point-of-care diagnostic test will be determined using reference tests performed under     controlled laboratory conditions. For this, clients receiving routine care in the ANCs at the     New Nyanza Provincial General Hospital (NNPGH) and Kisumu District Hospital (KDH) will be     consented to provide blood for the proposed study. Study volunteers will receive HIV and     syphilis rapid tests provided as part of routine care, and will donate an additional blood     for evaluating the MBio test against the reference tests in a laboratory setting. This study     is an investigational prototype, not for product registration. The results from this study     will be used to inform product development of a second iteration of the MBio device design.     At the time that the device is ready to be registered, it will undergo another field     evaluation at which time it will be submitted to the appropriate regulatory body. Because the     MBIO device is an HIV test, the device would be submitted to National AIDS & STI Control     Program (NASCOP), which is the appropriate regulatory body for HIV tests in Kenya.   "
134020|NCT01530646|"     It is known that dieting (restricted energy intake) without resistance training leads to a     reduced metabolic rate, and the loss of both fat and muscle mass. When exercise is not     included in a period of restricted energy intake, the degree to which muscle mass is lost is     highly dependent upon protein consumption. Whey protein is a high quality protein isolated     from milk and is known to stimulate new protein synthesis for all proteins in your body.     Previous research has established that the consumption of whey protein has been correlated     with retaining muscle mass while stimulating fat loss. However, the mechanisms behind these     findings is still unknown. The purpose of this study is to establish a mechanistic     underpinning to the efficacy of whey protein versus soy protein and a carbohydrate control     (maltodextrin), in promoting fat mass loss and lean mass retention during a period of     short-term controlled dietary energy deficit (-750 kcalories/day).   "
134021|NCT01530620|"     The purpose of this clinical study is to compare efficacy and safety of propiverine     hydrochloride extended and immediate release formulations in patients suffering from     neurogenic detrusor overactivity.   "
134022|NCT01530607|"     This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian     failure following chemotherapy in early stage, hormone-receptor negative breast cancer.   "
134023|NCT01530594|"     This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose     dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose     dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma     without an intent for immediate autologous stem cell transplant.   "
134024|NCT01530581|"     This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF     stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for     Haematologic Malignancies.   "
134223|NCT01527981|"     This study is a pilot behavioral intervention trial, designed to initially examine cognitive     behavioral therapy for medical adherence and depression (CBT-AD) in patients with depression     and poorly controlled type 1 diabetes.   "
134026|NCT01530555|"     To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG,     Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired     severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who     are transfusion dependent. To compare the response rate of the combination of rabbit ATG     (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of     matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®)     and CSA; obtained from the EBMT database (comparative study).   "
134027|NCT01530542|"     This is an open-label (both the physician and healthy volunteer know which medication will be     administered), single-dose, 5-dosing period study to characterize the pharmacokinetics     (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the     body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place     over approximately two and a half months and will consist of three phases: a screening visit     to determine eligibility for the study, a 5-dosing period treatment phase, and an     end-of-study visit.   "
134028|NCT01530529|"     The purpose of this study is to assess the bioavailability, safety, and tolerability of a     modified-release formulation of PF-05180999 relative to an immediate-release formulation in     healthy adult subjects. Two doses of the modified-release formulation and one dose of the     immediate-release formulation will be evaluated under fasted conditions. One dose of the     modified-release formulation will also be evaluated in the presence of food.   "
134029|NCT01530516|"     Class II malocclusion (mismatch between the upper and lower jaw in which the lower jaw     appears to be smaller from a profile point of view) are common in the general population.     Around 1/3 of the population have some degree of this skeletal/dental problem and it is one     frequent reason why patients decide to undergo orthodontic treatment. Treatment alternatives     will basically depend on the facial skeletal development of the patient and also on the     magnitude of the skeletal/dental discrepancy.      For patients that are not yet fully skeletal mature, the treatment of mild to moderate Class     II malocclusion involves a combination of a small skeletal growth modification effect and     more significant dental movements. For skeletal mature individuals with a severe mismatch,     the treatment usually involves jaw surgery to fully correct the malocclusion. For less severe     cases orthodontic camouflage exclusively done by orthodontic movements is an option.      If the case is not severe enough to warrant a surgical approach there are several treatment     alternatives. One of the most commonly used options is the use of orthodontic loaded springs     that apply forces through brackets and arch wires bonded into the teeth so that the teeth     will interrelate better.      A different alternative was proposed some years ago. The Xbow (spelled Crossbow) appliance     differs from the above-proposed option in that no brackets are bonded or arch wires used. The     orthodontic springs are applied to a metal framework cemented on some upper and lower teeth.     Once the skeletal/dental problem is believed to have been significantly improved, fine tuning     of the remaining dental problems is managed with brackets and arch wires. The theoretical     advantage of such a design is that adverse effects, such as root resorption and     decalcification from the long-term use of brackets and arch wires, are theoretically     minimized as the brackets and arch wires have to be used for a shorter period of time.      Although there are some retrospective reports about the skeletal and dental effects of the     Xbow appliance and only one prospective trial comparing the skeletal and dental changes to a     non-treated growing sample; no randomized clinical trial has yet evaluated the changes     compared to a current standard of care alternative which is the simultaneous use of loaded     springs concurrent with brackets and arch wires.   "
134030|NCT01530503|"     The purpose of this study is to assess the therapeutic activity of capecitabine alone or in     combination with mitomycin C as second-line therapy in patients with advanced/metastatic     biliary adenocarcinoma in progression after gemcitabine and platinum compounds   "
134031|NCT01530490|"     The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF)     cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of     cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.   "
134032|NCT01530477|"     This study is being conducted to examine the performance of three common DXA machines (1)     Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body     fat.   "
134033|NCT01530464|"     This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with     the primary objective of testing the safety and tolerability of combined oral doses of     aminophylline and ambrisentan in healthy human subjects. The secondary objective is to assess     the pharmacokinetic profiles of theophylline (aminophylline) and ambrisentan when     administered alone or in combination. It is hypothesized that the combination of these drugs     is generally safe, and that no drug interaction can be observed.   "
134034|NCT01530451|"     The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia     in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the     quality of life will be measured.   "
134035|NCT01530438|"     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that involves not only     motor structures, as was previously thought, but also brain areas dealing with cognition as     well as parts of the limbic system. Clinical, imaging and pathological evidence suggests that     ALS and fronto-temporal dementia (FTD) have several features in common, and that these two     diseases could be the two ends of a pathological continuum.   "
134036|NCT01530425|"     Two wheelchair types available for children in Kenya are compared for energy costs, utility,     and complications. This study will arrive at a protocol for comparing wheelchairs in     low-income settings, and in the process, provide wheelchair makers and providers with     specific feedback. It also serves as a means to increase the skills of local health     professionals working with the children in this study, while providing them with appropriate     wheelchairs to use.   "
134037|NCT01530412|"     Sustained improvement after pulmonary rehabilitation in activity levels as measured by an     activity armband.      Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and     prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also     strong evidence that supports the use of pulmonary rehabilitation to decrease hospital     admissions thereby reducing cost of care. Recent studies suggest that the significant     benefits achieved through rehabilitation fade with time and that in order to improve     activities of daily living; for example, average daily number of steps, programmes of longer     duration are required.      The primary aim of this study is to identify objective sustained improved in activity levels     using the SenseWear activity armband after a short-term pulmonary rehabilitation programme.     Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.   "
134038|NCT01530399|"     The objective of this study is to determine the dose response relationship regarding blood     loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid     in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the     study is to define minimally effective dose of MDCO-2010.   "
134039|NCT01530386|"     The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated.     The present study is being conducted to assess the effects of Lacosamide on sleep quality in     healthy subjects.   "
134040|NCT01530373|"     Hot flashes present a considerable problem for many breast cancer patients; these symptoms     may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This     study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in     reducing hot flashes, compared with clonidine (a medication often used for treating hot     flashes).   "
134041|NCT01530360|"     Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The     investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of     hyper- and hypoxia can be accomplished during the first three days of life in infants born     before 28 completed weeks of gestation. The investigators developed a treatment guideline and     a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be     reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10     infants.   "
134042|NCT01530347|"     Segment 1- this segment will include two main steps:      Step 1-Calibration: During this step we plan to collect paired measurements of capillary     blood glucose using reference method and data generated by the non invasive study device.     Samples will be obtained at specific time points during 4 hours: at fasting, and after     consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary     blood glucose will be measured using the invasive reference method. The paired reference and     study device data will be analyzed using multivariate regression model to formulate a     calibration algorithm model. This model will convert the acetone values measured by study     device to blood glucose values.      step 2-Validation: During this segment the second step of this segment we plan to evaluate     the validity and reliability of the non-invasive breath-based glucometer compared to standard     invasive reference glucometer. Results will be compared using a Clark error grid.      Segment 2- During this segment we plan to collect paired measurements of capillary blood     glucose beta Hydroxybutyrate using reference method and acetone values generated by the non     invasive breath based study device. Samples will be obtained at specific time points during 4     hours after overnight fasting, while basal insulin will be suspended, which is accepted to     produce ketosis.   "
134043|NCT01530334|"     the primary objective is to characterise the impact of gefitinib on the Response Evaluation     Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ;     confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR;     confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients     with EGFR M+ NSCLC   "
134044|NCT01530321|"     This study will determine the number of visits to a chiropractor for spinal manipulation and     light massage necessary for the optimal relief of cervicogenic headache (headache with     associated neck pain). Effectiveness of care will also be determined.   "
134045|NCT01530308|"     The investigators propose a multicenter, randomized, double-blinded, placebo-controlled trial     to study the effect of additive low-dose haloperidol prophylaxis on top of exciting care in a     general population of older patients (age 70 years and over) acutely admitted to the hospital     through the emergency department (ED) for general medicine and surgical specialties, and who     are at-risk for developing in-hospital delirium on admission according to the VMS delirium     risk questions (one or more positive answers out of three questions).      The investigators hypothesize that this intervention will reduce the incidence of in-hospital     delirium as well as duration and severity of delirium.   "
134046|NCT01530295|"     Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in     Patients with High Risk Prostate Cancer.      The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and     prednisone are effective in the treatment of high risk localized prostate cancer.   "
134047|NCT01530282|"     The study aims to assess the agreement between respiratory mechanics parameters measured     noninvasively by means of brief airways occlusions at the beginning of inspiration and the     reference parameters obtained with standard techniques of esophageal and gastric pressure     under static and dynamic conditions in a mixed population of ICU patients mechanically     ventilated in pressure support ventilation mode.   "
134052|NCT01530217|"     Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study     is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office     bleaching.      Methods: 30 health adults who received either placebo or ibuprofen. The drugs were     administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours     during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity     will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4. The     shade evaluation will be performed before and 30 days after bleaching with visual shade guide     and spectrophotometer.   "
134053|NCT01530204|"     The primary question addressed by this prevention study is to explore if improving pain and     disability reduces episodes of Major Depression among seniors with knee osteoarthritis (OA)     and mild depressive symptoms.   "
134054|NCT01530191|"     The specific aim of this study is to determine if pre-existing depression and anxiety affect     perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.        -  Hypothesis 1: Patients with depression will have increased analgesic use and longer          hospital stays postoperatively        -  Hypothesis 2: Patients with anxiety will have increased analgesic use and longer          hospital stays postoperatively.      A secondary aim is to characterize the incidence and severity of depression and anxiety in     patients scheduled to undergo surgery for pelvic organ prolapse.   "
134055|NCT01530178|"     There are many recent advances in insulin treatment of type 1 diabetes, however after a meal     sugars are always a concern. There is a drug sitagliptin (Januvia) which is FDA approved to     treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals.     This study is going to test whether this drug can improve the after meal sugars in people     with type 1 diabetes. To test this you will be given a test mixed meal and its effects on     insulin, other hormones that affect blood glucose as well as your sugar will be measured by a     series of blood tests. Insulin dose will be reduced by 20-50% to prevent low blood sugars     which might occur because of food staying longer in the stomach than usual or due to the     suppression of a hormone called glucagon which increases blood sugar. If you qualify you will     be given sitagliptin (Januvia) 3 different times in 25 mg, 50 mg and 100mg dosages. You and     the researchers will not know which dose you are taking at any single visit. A total of 30     people in which some will be children aged 13- 17 and others will be adults aged 18-30 will     participate. Some will have had diabetes for over a year, others will be within 3 months of     having been found to have type 1 diabetes. Furthermore, only 18-30 year people who are     diagnosed with type 1 diabetes for a year or more will be studied initially (4 subjects) to     establish safety data before younger subjects are enrolled into the study.   "
134056|NCT01530165|"     The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the     prevention of type 2 diabetes. Approximately 20,000 people From four communities will be     screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those     found to be at increased risk will be given an oral glucose tolerance test. People who, after     the oral glucose tolerance test, are identified as having prediabetes will have the     opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention.     This consists of culturally adjusted preventive strategies focusing on diet and physical     activity in real-life settings. Another important aspect of this trial will be to assess the     impact of urban planning on the prevalence of obesity and diabetes.   "
134057|NCT01530152|"     Aim:      The aim of the method evaluation study is a comparing study of Truview PCD™ (Picture Capture     Device) laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis     for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.      The laryngoscopes are compared according to their ability to visualize the glottis area     measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade.      A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible     decrease of the saturation will also be made.      Hypothesis:      The Truview PCD™ laryngoscope provides a better view of the vocal cords and thereby makes the     intubation les difficult.      CL 1 is achieved in 90 percent of intubations with the Macintosh laryngoscope, and the     hypothesis of the study is that CL 1 can be increased to 98 percent by use of the Truview     PCD™ laryngoscope.   "
134058|NCT01530139|"     The concept of personalised nutrition emerged following the sequencing of the human genome in     2000. It was hoped that with the identification of gene nutrient interactions, an     individual's response and susceptibility to particular diets would be better understood and     therefore appropriate dietary modifications could be made to optimise health and lower     disease risk. Then Food4Me aims to study the development of personalized nutrition at three     levels and determine whether providing more personalised dietary advice leads to better     compliance and health outcomes compared to standard population advice.      The hypotheses to be tested in the Food4Me study are as follows:        -  Personalisation of dietary advice assists and/or motivates consumers to eat a healthier          diet and follow a healthier lifestyle (in comparison with impersonal [conventional]          dietary advice).        -  Personalisation based on individualised biochemical (phenotypic) and/or genetic          information is more effective in assisting and/or motivating study participants to make,          and to sustain, appropriate healthy changes to their usual (habitual) diet and          lifestyle.   "
134059|NCT01530126|"     The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth     Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced     periodontal osseous defects at 6 months of healing.   "
134060|NCT01530113|"     The study aims to develop a theoretical model explicating the inter-relationships between     Childhood Sexual Abuse (CSA), Partial Vaginismus (PV) and Labor Dystocia (LD), including     their associations with Depression (D) as a mediating variable.      The following research hypotheses will be tested:        1. CSA will serve as a risk factor for D, PV and LD.             -  pregnant women with a history of CSA will have higher levels of D compared to               pregnant women without a history of CSA.             -  pregnant women with a history of CSA will have more PV compared to pregnant women               without a history of CSA.             -  pregnant women with a history of CSA will have higher levels of LD compared to               pregnant women without a history of CSA.        2. D will serve as a mediator between prenatal PV and LD.        3. PV will serve as a risk factor for LD.        4. postpartum PV will be affected by childbirth (LD vs. no LD) contingent on the level of          D.   "
134063|NCT01530074|"     The purpose of this study is to determine the contribution of the innervation of the     contra-lateral mandibular nerve for the innervation of the lower lip area.      The investigators hypothesis is that the sensation of the lower lip is contributed by both     mandibular nerves (from both sides of the jaw).   "
134064|NCT01530061|"     This study will determine which breakfast (egg breakfast or bagel breakfast) has the most     beneficial effect on appetite.   "
134065|NCT01530048|"     This trial is conducted in Europe. The aim of this trial is to test if there is     bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin     aspart 200 U/mL (U200) formulation.   "
134115|NCT01529398|"     People with knee osteoarthritis (OA) have functional instability and defective neuromuscular     function, it was recently suggested that sensorimotor exercises may be important and needed     to improve the effectiveness of training programs for these patients. This study objective     was to compare the effectiveness of a supervised resistance muscular training (RT) versus     sensorimotor training (SMT) for patients with Knee OA, on decrease of pain and functional     improvement.   "
134066|NCT01530035|"     A one-year intervention study of 41 healthy elderly men aged 65-75-years.Of these, 24     subjects are untrained men with no regular training activity for the last 5 years. After     medical screening and pre-testing, they will be randomized into a football group (n=9), a     strength-training group (n=9) or a sedentary control group (n=6). Additional 17 subjects are     recruited from local football clubs and have been active football players for the last 40     years. Training will be performed 3x1 hour per week and evaluation will take place after 0, 3     and 12 months. Primary endpoints will be changes in cardiac and vascular structure and     function measured by advanced echocardiography (tissue Doppler and speckle tracking imaging),     and peripheral arterial tonometry (Endo--‐PAT device). Secondary endpoints will be evaluation     of potential changes in VO2 max, blood pressure, muscle capillaries, lipid profile,     circulating catecholamines, body composition, and insulin resistance.   "
134067|NCT01530022|"     The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological     effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after     administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also     be collected.   "
134068|NCT01530009|"     The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable     effect on upper gastrointestinal motility compared to placebo. In particular, induction of     phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary     outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular     contractions that pass through the walls of the stomach and intestinal tract during the     fasting state. It is characterized by an initial period where there is a minimal electrical     activity and muscular contraction (phase I), followed by a gradual increase in the frequency     of contractions (phase III) that often leads to a characteristic cluster of contractions     (phase III). This cycle occurs only in the fasting state in normal individuals and the     frequency of phase III is quite varied, dependent on age and the presence of any underlying     abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics     of the MMC, patient demographics in responders and non-responders, and the safety profile of     AMX at the intervention dose.   "
134069|NCT01529996|"     The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG     laser in the treatment of facial redness.   "
134070|NCT01529983|"     The primary objective of this study is to compare the efficacy of intense focused ultrasound     and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.   "
134071|NCT01529970|"     Parkinson's disease (PD) is the second most frequent neurodegenerative disorder after     Alzheimer's disease. It causes motor dysfunctions, such as bradykinesia, resting tremor,     rigidity and postural instability. Although PD appears to be sporadic in most cases, several     causative genes and susceptibility factors have been identified that cause familial forms of     the disease with Mendelian inheritance with autosomal dominant or autosomal recessive     inheritance.      Approximately 5~10% of patients with the clinical picture of PD carry a mutation in one of     the known genes that cause monogenic forms of the disorder. The average age at onset is     between 60 and 80 years and the average age of diagnosis is 60 years. Onset of primary     parkinsonism before 50 years is known as early onset parkinsonism(EOP). Onset between 20 and     50 years is known as young-onset PD. Onset at younger than 20 years is known as juvenile     parkinsonism (JP). At least, 13 loci and 9 genes are reported. The investigators study is     aimed to screen the clinical diagnosed familial EOP for the common mutation site by PCR/DNA     sequencing. The gene for screen are Parkin (pattern: PARK2), PINK1 (pattern: PARK6) and     ATP13A2 (pattern: PARK9).   "
134072|NCT01529957|"     The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in     healthy Chinese volunteers.   "
134073|NCT01529944|"     This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation     status and investigate the impact of the PTPN11 mutation status on the effect of somatropin     (Norditropin®) by use of data obtained in the GHNOO-1658 trial.   "
134074|NCT01529931|"     The current study is a follow up study designed to gather information about the effect of the     number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic     Hair2Go treatment. This study includes taking photos and documenting endpoints but does not     include treatments.   "
134088|NCT01529749|"     This is a open controlled trial in which 48 HIV-1 patients successfully treated with     EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The     four arms are as follows:      Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF +     MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)      The allocation will take place in two phases:      Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan      If losartan arm shows benefits we will proceed to the second phase:      Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.      Patients will be followed up during 12 months to determinate the proportion of patients with     decreased collagen deposition in TL equal to or greater than 50%.   "
134089|NCT01529736|"     Osseotite implants placed with higher insertion torque (TEST procedure) will have higher     initial stability and integration success than those placed with lower insertion torque     forces.   "
134075|NCT01529918|"     This pilot RCT study aims to develop and evaluate the uptake, feasibility, and potential     value of a strategy for web-diabetes risk assessment versus paper-based methods in an     undiagnosed diabetes population over 40 years of age from all listed FHT provided through an     electronic medical record database. Following randomization, intervention participants will     have the option to decide to use web-based self-screening and the control group will receive     only a paper-based method. There will be two options for web-based screening; one involves     completion of the CAN-RISK screening tool as part of a personal health record self-management     program (MyOscar) versus a one off online risk-assessment. The intervention and control group     will be compared with respect to risk-assessment uptake. Educational sessions and further     assessment of diabetes conducted by the clinical health care team will be offered to all     participants who scored a high risk of diabetes in accordance with the CAN-RISK results.     Actual numbers of diabetes cases in those with a high risk score will be compared between the     intervention and control groups as well as compared to the usual method of diabetes screening     in a randomly chosen non-identifiable sample from the same clinical setting in the same one     year period. The assessment of patient acceptability in feasibility of the implementation of     the self-screening tool will be accomplished through surveys designed to be completed by     patients and staff.   "
134076|NCT01529905|"     The goal of this project is to study the course and outcome of illness in individuals who     present with a first episode of depression or mania, or who have a recurrent disorder but     have never received treatment. We plan to examine psychological, physical, social and     environmental factors that may affect long-term outcome in these disorders   "
134116|NCT01529385|"     The purpose of this study is to determine whether a specially designed sock for people with     diabetes and swelling in the legs can reduce the swelling, improve blood flow to the legs,     and improve physical activity patterns of those individuals by providing mild compression to     their legs.   "
134117|NCT01529372|"     The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be     conducted on twenty (20) eligible patients with a twelve month follow-up period.   "
134077|NCT01529892|"     Methamphetamine abuse and addiction are widespread and is causing increasing pressures on     social, public health and criminal justice systems worldwide. Some of the risk for developing     addiction may be genetic. Identifying specific genotypes and understanding their interactions     with the environment may help predict who is at risk for developing a disease. In this study     the investigators are evaluating the contribution of differences in one genotype - called     CYP2D6 to the removal of methamphetamine from the body. Methamphetamine is removed from the     body by special enzymes in the liver. One of these enzymes is called Cytochrome P450 2D6. The     activity of 2D6 is genetically determined. Some people have no active 2D6 whereas in others     2D6 is very active. One group of scientists found that people with low 2D6 activity were less     likely to become methamphetamine addicts. In this study the investigators will determine the     activity of your 2D6 by looking at the CYP2D6 genotype. If low levels of 2D6 decrease the     risk of methamphetamine addiction it may be because there is less of the chemicals (called     metabolites) made by 2D6. The first step in the metabolism (the process of removal of drugs     from the body) of methamphetamine by 2D6 is conversion of methamphetamine to amphetamine and     para-hydroxymethamphetamine. 2D6 then converts these to inactive chemicals. In addition to     determining your genotype, the investigators are interested in the relationship of genotype     with the methamphetamine metabolism. Thus, as part of this study, you will be given a modest     oral dose of 5 milligrams of methamphetamine. After receiving the methamphetamine you will     need to collect your urine for 24 hours.      The purpose of this study is to investigate the impact of genetic variation in CYP2D6 on the     disposition of methamphetamine in the human body as well as its pharmacologic effects to     humans.   "
134078|NCT01529879|"     Integration success rates and the preservation of crestal bone will be higher for the     experimental device than for the control implants.   "
134079|NCT01529866|"     Integration success rates measured by lack of implant mobility and crestal bone regression     measurement will be higher for the experimental implant design than for the control implants.   "
134080|NCT01529853|"     Primary Objective:      To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and     tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly     over a 6-week period.      Secondary Objectives:      To assess in adult patients with IPF:        -  The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests          (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.        -  The trough plasma concentrations of SAR156597        -  The potential immunogenicity of SAR156597.   "
134081|NCT01529840|"     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of     somatropin (Norditropin®) on final height in children with Noonan syndrome having being     treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal     final height in the original trial S/GHD/004/NOO.   "
134082|NCT01529827|"     This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose     total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT)     works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as     fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the     growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting     the donor's stem cells. When the healthy stem cells from the donor are infused into the     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood     cells, and platelets. Sometimes the transplanted cell from a donor can make an immune     response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and     methotrexate after transplant may stop this from happening   "
134083|NCT01529814|"     Integration success rates measured by resistance to countertorque testing will be higher for     the experimental implant design than for the control implants.   "
134084|NCT01529801|"     A study where dental implants with different roughened surfaces will be evaluated for the     ability to resist countertorque forces.   "
134085|NCT01529788|"     The objective of the study is to compare the time to onset of Dysport® versus Botox® in the     treatment of lateral orbital rhytids (crow's feet). Thirty subjects were enrolled in the     study; specifically 30 male or female patients 18 years or older with moderate to severe     lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated     with Dysport® on one side and Botox® on the other side. Both the injector and patient were     blinded to the injected toxin.      The efficacy endpoints were determined by investigator and subject live assessment of crow's     feet at rest and maximum contraction at each visit (every other day for 6 days     post-injection, every month for 9 months following) using a validated 5 point photographic     scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or     severe wrinkles [4]) used in previous studies. A written description of each photograph was     included to help standardize the application of the Photographic Scale.   "
134090|NCT01529723|"     Dysphagia or swallowing difficulty is common after stroke occurring in 25-78% of stroke     survivors depending on the anatomic location of the stroke and the diagnostic test used.     There are no universally accepted methods for doing a screen test at the bedside in the     immediate setting after stroke. This study will assess the reliability of a bedside screen in     terms of reproducibility of results between 2 independent screeners and in comparison to a     fiberoptic study done by a speech language pathologist.   "
134118|NCT01529359|"     The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane     Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).   "
134119|NCT01529346|"     The objective of this study is to evaluate the overall pain relief of a single dose of     PF-05089771 against placebo following third molar extraction.   "
134120|NCT01529333|"     The purpose and objective of this study is to evaluate the safety and efficacy of the MET V     System for the treatment of individuals with mixed hearing loss.   "
134091|NCT01529710|"     Clinical Trial Phase:Phase III      Primary Objectives:        -  Compare Mirazid and Praziquantel cure rates for both Schistosoma species.        -  Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both          Schistosoma species.      Secondary Objective:Identify and compare the types and severity of side and adverse effects     between the Mirazid and Praziquantel.      Study Population:200 Schistosomiasis infected persons of both types of Schistosomiasis aged     from 15-35 years. Those subjects will be selected from among those screened.Subjects will     include both genders excluding chronically ill such as chronic liver disease patients and     those with both types of Schistosomiasis.      Recruitment Period:3 months and subjects follow up for another 3 months followed by 3 months     for statistical analysis and report writing Study Duration: Total study duration is expected     to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data     management and report writing.      Endpoints: Will be measured at 3 months of successful administration of treatment either     Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the     response to treatment will be done by examining urine or stool of the subject for presence of     Schistosoma eggs and its density if found.      Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will     indicate treatment success. One positive sample collected at week 12 will indicate infection     with Schistosomiasis.   "
134092|NCT01529697|"     Inhaled medications are the mainstay of the therapeutic management of respiratory disorders.     Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are     often improperly used. However, there is no tool that can detect and record errors in either     the timing or the method dose administration      The investigators designed a device that makes an acoustic record each time an inhaler is     used. Opening the device makes an acoustic file which is recorded, this file is     time-stamped which means that the timing of drug administration is recorded. When the     device is retrieved and acoustic analysis performed, the steps involved in using the inhaler     can be determined. Hence, the subjects inhaler technique is assessed and errors in the     inhaler use identified. Together this means that errors in inhaler technique and timing of     use can be quantified.      In this study the investigators attached the device to a discus dry powder inhaler. In order     to eliminate the behavioral component of adherence and identify the mechanical issues     associated with effective inhaler use the investigators studied subjects who were already in     Hospital and already prescribed a discus inhaler. The investigators hypothesized that the     device would identify which errors in technique were the most common and that this would     provide insight into how these errors might be eliminated.   "
134093|NCT01529684|"     The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of     excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled     OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the     Optional Treatment Phase.   "
134094|NCT01529671|"     The purpose of the study is primarily to determine the safety and toleration and     pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.   "
134095|NCT01529658|"     The Objective is to determine if renal hypothermia during open partial nephrectomy results in     improved post-operative renal function compared to warm ischemia.      Primary Aim is to determine the effect of hypothermia on preservation of overall renal     function compared to no hypothermia in patients who require hilar vessel clamping during open     partial nephrectomy for a renal tumor.      Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal     function.      Secondary Aim is to determine the effect of hypothermia on preservation of affected renal     function (kidney with the tumor) compared to no hypothermia in patients who require hilar     vessel clamping during open partial nephrectomy for a renal tumor.      Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal     function.   "
134096|NCT01529645|"     This study will evaluate the safety and efficacy of 9 different vaccines containing aP     (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy     subjects 18 to 40 years of age.   "
134097|NCT01529632|"     The study assessed the safety and efficacy of the fixed combination product QVA149 versus the     component products QAB149 and NVA237, administered concurrently, in patients that have     moderate to severe chronic obstructive pulmonary disease (COPD).   "
134098|NCT01529619|"     This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine     patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase     Inhibitors.   "
134099|NCT01529606|"     The main objective of this entire research project is to develop a miniature atmospheric cold     plasma brush (m-ACPB) for dental clinical applications. The objective of the clinical trial     portion of the study is to compare the longevity and durability of dental composite     restorations created using the plasma brush, to that of the standard care in dentistry for     treating dental cavities, and effects on caries prevention.   "
134109|NCT01529476|"     1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with          Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)        2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients          with CAP after continuous oral administration and determine the pharmacokinetic          (PK)/pharmacodynamic (PD).   "
134100|NCT01529593|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of temsirolimus and metformin that can be given to patients with advanced cancer.     The safety of the drug combination will also be studied.      Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause     cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread of     cancer cells or possibly kill them.      Metformin was designed to treat patients with diabetes. It may be able to block the protein     mTOR and slow the growth of tumors.   "
134111|NCT01529450|"     This is a prospective single-center, open label, pilot study to investigate the safety and     efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.      Primary Objectives:      • To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals     with locally advanced or metastatic BCC who have been previously treated with a non-LDE225     Smo inhibitor.      Secondary Objectives:        -  To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii          1, 2, Patched 1,2 and Ki67) in individuals which are non-naive to Smo inhibitors other          than LDE225, at baseline and at end-of-treatment        -  To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225          Smo inhibitor usage        -  To assess the overall survival rates of individuals with locally advanced BCC or          metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with          LDE225   "
134101|NCT01529580|"     This project will address a major challenge to the field of autism research: improving     expressive communication in children with autism who have reached school age but have not     acquired functional spoken language (non-verbal school aged children with autism; NVSACA).      Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger     site and follow-up testing but continue to have minimal functional spoken language will be     participants in this study. After eligibility is established, participants will be randomly     assigned to a baseline duration of one week, two weeks or three weeks before the start of     active treatment. Once the baseline duration is completed, participants begin active     treatment one hour of intervention three days per week in the participants' school setting.     In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to     improve the child's generalization of skills and teach parents the strategies implemented in     their child's treatment. Post-baseline and post-treatment assessments will be completed in     the lab at a time that is convenient for the participants' families.   "
134102|NCT01529567|"     Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral.     They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both     programs include mindfulness training, education about how excessive avoidant and control     behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One     of the programs also includes instructions on how to perform systematic exposure. The     hypothesis of the study is while both groups will show improvement in terms of IBS symptom     severity and quality of life, the addition of systematic exposure will lead to more     improvement in symptoms.   "
134103|NCT01529554|"     Acute myocardial infarction (AMI) constitutes the major cause of death in most nations and     death rates and morbidity remain substantial in the years thereafter. Inflammation is a     hallmark throughout the distinct stages of atherosclerotic lesion formation preceding AMI as     well as at the time of plaque rupture and during the post-infarct repair phase. Harnessing     its harmful consequences constitutes an attractive therapeutic approach to address this unmet     medical need.      The objectives of this study are to evaluate the effects of mTOR inhibition (everolimus) on     infarct size, myocardial function and inflammation in patients with ST-Elevation Myocardial     Infarction.      The efficacy objectives are:        1. (1° endpoint):           To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as          change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days          follow-up measured by MRI (Late Gadolinium Enhancement (LGE) for transmurality).        2. (2° endpoint):           To evaluate microvascular obstruction (MVO) as change from baseline (12-72 hours after          percutaneous coronary intervention) to 30 days follow-up evaluated by MRI.        3. (3° endpoints):             1. Change of left ventricular volume from baseline (12-72 hours after percutaneous               coronary intervention) to 30 days follow-up measured by MRI.             2. Change of biomarkers from time of coronary angiography to 30 days follow-up               including a time-course (AUC). Biomarkers comprise hs-TnT, NT-proBNP, hs-CRP, IL-6               and inflammatory biomarkers OPG, sRANKL, OPN and CCN1.      The safety objectives are:      To explore the effect of mTOR inhibition (everolimus) on several clinical and safety     laboratory parameters including plasma lipid levels and blood count. This will be     complemented by analysis of inflammatory cell subsets in coronary thrombi and peripheral     blood (CD4+ T helper lymphocyte subsets, monocyte subsets).   "
134104|NCT01529541|"     This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by     proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled     with metformin alone.   "
134105|NCT01529528|"     This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily     compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet     therapy or combination of diet and exercise therapy.   "
134106|NCT01529515|"     The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month     formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse     of the symptoms of schizophrenia.   "
134107|NCT01529502|"     The purpose of this study is to determine whether storage time affects how human body     responds to autologous blood transfusion. An autologous blood transfusion is when a person     donates blood and then receives that same blood back in the transfusion. We also want to find     out if in this situation inhaled nitric oxide can help to prevent the potential reduction of     vasodilation capacity. Vasodilation capacity is the ability of the blood vessel to widen when     needed.   "
134108|NCT01529489|"     Patients with chronic obstructive pulmonary disease (COPD) present slowed pulmonary oxygen     uptake (VO2) and heart rate (HR) kinetics compared with age-matched controls. Patients with     COPD present significant loss of body mass, decreased strength and endurance of respiratory     muscles and lower limbs, leading reduced exercise capacity. This reduced exercise capacity     can be marked by slowed kinetics of VO2 and HR at the onset of heavy-intensity exercise.     Additionally, derangements in the diffusive and convective transport of oxygen to skeletal     muscle mitocondria, and intramyocyte metabolic machinery, higher ventilation and disturbances     in mechanics of breathing, hypoxemia, pulmonary hemodynamics, autonomic balance, and     peripheral vasodilation, and accumulation of by-products that might be related to increased     muscle fatigability could slow the response of systemic (central) and peripheral     (microvascular) oxygen delivery to a point where the kinetics of VO2 might become limited by     O2 availability and HR. Thus, the physical training programs of the lower limbs, in addition     to presenting scientific evidence A, are important components, resulting in the reversal of     the manifestations of COPD, resulting in improvement in exercise capacity, well significantly     speeded VO2 and HR kinetics in patients with COPD. However, it should be taken into account     the choice of an appropriate program limitations and severity of disease. Assuming that COPD     patients present slower VO2 and HR kinetics, the investigators hypothesized that the     heavy-intense interval physical training in equipament elliptical would promote a greater     increase in the functionality (functional performance) and speeded kinetics in the cycle     ergometer and elliptical equipment constant-load intense exercises tests of COPD patients. In     this context, the present study intends to evaluate and compare the effects of resistive plus     aerobic physical training and interval physical training on oxygen consumption (VO2) and     heart rate (HR) kinetics responses at the onset in cycle ergometer and elliptical equipment     constant-load intense exercises tests in patients with COPD.   "
134112|NCT01529437|"     This is a study for children and adults who are interested in a new therapy for their     allergies to dust mite and timothy grass. The new therapy is called sublingual immunotherapy     and the investigators are testing if it is safe and well tolerated.   "
134113|NCT01529424|"     The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS     ApoC-III Rx vs. Placebo on fasting total apoC-III levels.   "
134114|NCT01529411|"     This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine     administered after the standard treatment of the combination gemcitabine+cisplatin, when it     has reached stabilization or response of the disease, as the first treatment inmeditely after     the diagnosis of advanced or metastatic urothelial cancer.   "
134124|NCT01529281|"     It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function     and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation     has been shown to increase protein synthesis and decrease muscle protein breakdown, however,     the effects of BCAAs on recovery from EIMD are unknown. Thus, the aim of this study was to     examine the effects of a BCAA supplement on markers of muscle damage.   "
134125|NCT01529268|"     CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years     with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD). The     primary objective is to evaluate whether 52 weeks of treatment with cysteamine bitartrate     delayed-release capsules will result in improvement in liver disease severity.   "
134126|NCT01529255|"     -  The purpose of this study is to to prove that the long-term efficacy of strategy of          treatment adjustment at W24 according to virological response based on ROADMAP concept          is better than standard of care strategy.        -  To evaluate the off-treatment durability of HBeAg seroconversion in patients who          discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml          with over 12 months consolidation treatment   "
134127|NCT01529242|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drug associations in the treatment of acute cutaneous rash in children between 2     and 12 years old.   "
134128|NCT01529229|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drug associations in the treatment of Moderate - Severe Persistent Allergic     Rhinitis.   "
134129|NCT01529216|"     The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System     (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured     as A1c, FBG and Post-Prandial Glucose levels.      The study hypothesis is that HbA1c will show greater improvement in patients receiving 12     months of therapy by the DIAMOMD System than in patients not receiving this therapy.   "
134130|NCT01529203|"     The aim of this study is to assess subjects' satisfaction linked to the pan facial management     of rejuvenation with injections of Azzalure® and Restylane® fillers.      This will be an open, multi-centre study.   "
134131|NCT01529190|"     Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been     shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central     sensitization. The IL-6, is detectable 60 minutes after surgical incision, persisting for     until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective of this study is     evaluating the analgesic effect of pregabalin and its repercussion on serum levels of IL6.   "
134132|NCT01529177|"     Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities     and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD).     Infertile men with unexplained infertility and IR may benefit from treatment with metformin.   "
134133|NCT01529164|"     Studies suggest that the addition of antiangiogenic agents to conventional therapeutic     strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase     clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has     become an important treatment option and its combination with chemotherapy is now being one     of the standard first line therapy. This phase II study was conducted to determine the     efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in     advanced colorectal cancer.   "
134134|NCT01529151|"     Western University of Health Sciences is seeking men and women to participate in a study on     the effectiveness of Osteopathic Manipulative Treatment (OMT) and Vestibular Rehabilitation     Therapy (VRT) in patients with vertigo. The purpose of this study is to examine the efficacy     of OMT in the treatment of individuals with vertigo, alone and in combination with Vestibular     Rehabilitation Therapy (VRT). Because of the health care costs associated with vertigo, the     cost effectiveness of OMT and VRT will also be examined.   "
134135|NCT01529138|"     This study is being done to determine the highest safe dose of the combination of     temsirolimus and axitinib; to learn the side effects when these drugs are given together; and     to determine how the patient's disease responds to treatment.      The combination of the drugs temsirolimus and axitinib has not been studied before so it is     unknown whether this treatment will have any benefit in the patient's cancer.      Temsirolimus is commercially available and approved for treatment of some types of kidney     cancer.      Axitinib has been tested in several diseases but it is not yet commercially available for the     treatment of any cancer in the United States.      The combination of temsirolimus and axitinib is not approved for treatment of any cancer     outside of a clinical trial.   "
134136|NCT01529125|"     It is unclear whether children with HIV and severe acute malnutrition can be started on     highly active antiretroviral therapy (HAART) safely while they are still malnourished and the     manner in which this therapy should start. This study will examine the safety, efficacy, and     metabolism of children started on HAART while still severely malnourished.   "
134137|NCT01529112|"     The purpose of this study is to compare the overall survival of patients receiving E7080 +     Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.   "
134138|NCT01529099|"     This is a postmarketing study to assess the overall performance and survivorship of the SIGMA     HP® PARTIAL KNEE SYSTEM.   "
134205|NCT01528215|"     The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to     implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate     up to five years after implant loading. The hypothesis is that there will be no clinically     relevant differences in marginal bone level alterations one year after functional loading.   "
134139|NCT01529086|"     The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident     prostate cancer, as detected on biopsy, among men who are at increased risk for the disease.     Dutasteride was compared with placebo for 4 years period. Results showed a relative risk     reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer.      For REDUCE, biopsies were defined as protocol biopsy if performed at certain timeframes,     and for cause if outside these predetermined timeframes.      The investigators propose a post hoc analysis that would allow them to include biopsies that     really justified a clinical indication, but were excluded from for cause analysis based on     occurring at either the 2 or 4 year timeframes.      Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as:      Group 1--dutasteride group biopsied for cause using several definitions: biopsy of patients     who received dutasteride whose PSA rose from nadir as defined in your own protocol,who had a     PSA rise>0.2 ng/ml or who had a new abnormal DRE or had a free PSA<12% . The investigators     define these as such because this would reasonably instigate biopsy if the clinician had a     patient with this scenario in the non-study setting.      Group 2--placebo group biopsied for cause using several definitions, regardless of     timeframe but reported at each year of the study and aggregate, with the aggregate number     being the primary outcome. Thus the investigators would request results of biopsy of patients     who received placebo To establish differences in biopsy positive rates the groups as per each     definition listed, to determine if dutasteride decreased the likelihood of for cause biopsy     compared to not for cause biopsy, and if there is a difference in cancer detection risk     rate depending on cause vs. no cause in that group compared to placebo.   "
134140|NCT01529073|"     Objectives: 1. Primary objective: To Evaluate the rate of sustained virological response     (SVR) of pegylated interferon alfa-2b (Peg-IFN) plus ribavirin (RBV) plus nitazoxanide (NTZ)     in patients coinfected by HIV and HCV genotype 4 (HCV-4), never treated before (naïve) and     with a treatment failure to a standard therapy with Peg-IFN plus RBV (experienced), and to     compare it with the rate of SVR of these patients with Peg-IFN plus RBV is a historical     cohort. 2. Secondary objectives: In naive, as well as in experienced patients: a) To evaluate     the virological activity at weeks 4 and 12 after starting the combination of Peg-IFN plus RBV     plus NTZ in HIV/HCV-4-coinfected patients. b) To analyze the safety of Peg-IFN plus RBV plus     NTZ in HIV/HCV-4-coinfected patients.      Design: Pilot clinical trial without control to evaluate efficacy and safety (phase II).      Patients: Individuals with HIV infection and with confirmed chronic HCV infection.      Treatment: NTZ 500 mg every 12 hours during 4 weeks, followed by NTZ 500 mg every 12 hours     plus Peg-IFN plus weigh-adjusted RBV for 48 weeks. Total duration of therapy: 52 weeks.      Primary variable: The proportion of patients with HCV RNA ≤10 IU/ml 24 weeks after finishing     the programmed length of treatment.      Secondary variables: 1. The frequency of individuals with HCV RNA ≤10 IU/ml 12 weeks after     finishing the programmed length of treatment. 2. The proportion of patients with HCV RNA ≤10     IU/ml at 4 and 12 weeks after adding PegIFN plus RBV to NTZ. 3. The frequency of severe     adverse events.   "
134141|NCT01529060|"     The investigators have learned in past research that the drug phenylbutyrate can decrease the     amounts of branched chain amino acids and their byproducts in the bloodstreams of healthy     volunteer patients and also patients with certain disorders of protein breakdown including     maple syrup urine disease. Through this study, the investigators will try to find out how     well phenylbutyrate (NaPBA), also known by name brand Buphenyl-TM, decreases BCAA and     branched chain keto chain acids in the blood of patients with MSUD. The investigators hope is     that through this research the investigators will be better able to treat these patients.      Subjects with MSUD will take phenylbutyrate (NaPBA) in powder form for a two-week treatment     period and powder placebo, a substance with no effect on the body, for a two-week treatment     period. They will be given the same amount of powder and undergo the same laboratory testing     during both of the two-week treatment periods. The results will be compared once the study is     over.   "
134142|NCT01529047|"     Rates of gambling and substance use behaviors are elevated among emerging adults (ages     18-24), and these behaviors are individually and jointly associated with a host of negative     consequences. Evidence suggests there is significant overlap between these behaviors as well     as comorbidity of associated mental disorders (i.e., pathological gambling and substance     abuse/dependence). Prior research suggests that a brief in-person delivered personalized     feedback intervention (PFI) may be an effective method of reducing these behaviors and their     associated consequences among emerging adults. Thus, the purpose of this study is to     determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in     reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample     of emerging adults, as well as explore potential moderators and mediators of intervention     efficacy and the longevity of intervention effects (over a period of 18-months).   "
134143|NCT01529034|"     The purpose of this study is to examine the long-term safety and tolerability of USL261 in     the treatment of seizure clusters.   "
134144|NCT01529021|"     Millions of children in North America receive an annual flu vaccination, many of whom are at     risk of experiencing severe distress. Children frequently use technologically advanced     devices such as computers and cell phones. Based on this familiarity, the investigators     introduced another sophisticated device - a humanoid robot to- interact with children during     their vaccination. The investigators hypothesized that these children would experience less     distress than children who did not have this interaction.   "
134145|NCT01529008|"     Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of     the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.     Core decompression is currently the treatment of choice for early stage osteonecrosis of the     femoral head. This method consists in decompressing the rigid intra-osseous chamber to     promote revascularization, thus halting progression of the disease and stimulating repair.     Still this treatment remains highly controversial, since the success rates of the first     studies have not been repeated.      The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated.     Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures,     microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells     recruitment.      Three studies have indicated the potential clinical benefits of cell-based approaches for the     treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004).     This is on the basis of these observations that a proprietary population of autologous     osteoblastic cells (PREOB®) has been developed.      This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment     of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study     is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is     superior to core decompression/placebo implantation in relieving hip symptoms and halting (or     reverting) radiological progression of the disease.   "
134206|NCT01528202|"     The aim of this investigation was to examine the effects of tart Montmorency cherry juice on     urinary 6-sulfatoxymelatonin and sleep quality using a double-blind, placebo-controlled,     cross-over design.   "
134146|NCT01528995|"     Fecal incontinence (FI), the involuntary loss of solid or liquid stool, is a stigmatising     condition. It can have a distressing impact and restriction on quality of life.     Obstetric-related fecal incontinence may occur early after childbirth. Previous obstetric     injury is a major cause of fecal incontinence in older women.      When conservative treatment fails, surgery may be an option. Both sacral nerve modulation and     anal bulking injections is minimal invasive surgical alternatives. Step one in SNM is a trial     period of temporary stimulation. If the test is successful, the patient can have an     implantable stimulator (step 2). Transanal submucosal bulking injection of collagen is also a     possible treatment option and can be an effective treatment for faecal incontinence.      The purpose of this study is to compare the efficacy of sacral nerve stimulation to anal     bulking injections in women with fecal incontinence after obstetric sphincter injuries     (OASIS), through a multicenter blinded, randomized controlled trial.   "
134147|NCT01528982|"     The goal of this study is to assess the risk factors for the development of pathological     gambling.   "
134241|NCT01527747|"     The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on     fasting and post-meal blood triglyceride (blood fat) levels.   "
134148|NCT01528969|"     1. The present controlled, randomized, doubleblind study aims to answer the following          questions:             -  How will the normal flora be affected by the xylitol consumption?             -  Will daily consumption of xylitol change the plaque-saliva distribution of the               mutans streptococci?             -  The association of the test results will also be compared with the caries status at               the baseline.        2. About eighty subjects with MS counts of log CFU 5 or more will be identified and invited          to the study. They will be randomly divided into a Xylitol and Sorbitol group.        3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be          collected before and after gum use.        4. Studying and quantifying of 16 bacterial species belonging to the normal flora by          DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora          in general.   "
134149|NCT01528956|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research trial studies genes in samples from younger patients with     adrenocortical tumor.   "
134150|NCT01528943|"     The purpose of this study is to investigate the effect of continuous perioperative infusion     of prostacyclin on haemostasis and endothelial functionality in patients undergoing major     abdominal surgery.   "
134151|NCT01528930|"     The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in     human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea,     the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and     Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may     require multiple drugs.      Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin     treatment is limited by its systemic route of administration and a lot of adverse events.     Amikacin inhalation treatment could overcome these limitations and also could be effective     for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The     purpose of this study is to determine whether amikacin inhalation treatment is effective in     patients with MAC infection who experienced treatment failure after standard treatment for     more than 6 months or with M. abscessus infection.   "
134152|NCT01528917|"     This is a Natural History study to characterize key aspects of the clinical course of late     onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).   "
134153|NCT01528904|"     The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with     clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US)     parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease     (AITD).   "
134154|NCT01528891|"     To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of     Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus     Injection of Dexmedetomidine.   "
134155|NCT01528878|"     The purpose of this study is to determine a tolerable dose of radiation delivered by the     CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).   "
134156|NCT01528865|"     Therapy for non-Hodgkin lymphoma (NHL) is in evolution as new molecular pathways and targeted     therapies are identified. Although most NHLs respond to currently available therapies, the     majority of patients relapse and many never have a complete response to therapy. In the     investigators attempts to further understand the pathogenesis of NHLs, the investigators have     identified and characterized expression of human endogenous retroviruses (HERVs) at the DNA,     RNA and protein levels in association with the presence of NHLs (and other neoplastic     diseases). The investigators preclinical evidence suggests a correlation with the level of     HERV-K (a particular family of HERVs) expression and NHL disease activity, leading us to     hypothesize that HERV-K expression may contribute to the development of the disease and/or to     its recurrence. If this hypothesis is correct, then drugs that inhibit HERV-K expression may     prevent recurrence of disease and/or may provide a novel therapeutic approach for NHLs.      To test this hypothesis, the investigators eventually intend to study the use of     anti-retroviral therapies in patients with NHL. The investigators in vitro studies have     demonstrated that HERV-K expression decreases in response to the currently FDA-approved and     available, anti-HIV drugs, Lamivudine and tenofovir disoproxil fumarate (tenofovir). These     medications are tolerated well in HIV patients, but it is unknown how the combination of     Lamivudine and Tenofovir will be tolerated by patients with NHL. To further test the     investigators hypotheses, the investigators propose the following Specific Aims of the     current study: (1) To evaluate the tolerability, toxicity and safety of administering     Lamivudine and Tenofovir in combination to patients with relapsed or refractory NHL; (2) To     evaluate the effects of the combination of lamivudine and tenofovir on HERV-K plasma viral     RNA load; and (3) To monitor the response rate of the NHL to treatment with the combination     of lamivudine and tenofovir.      The investigators study will recruit adult patients with relapsed or refractory NHL whom the     investigators have identified as having expression of HERV-K. Volunteer participants will be     administered the combination of lamivudine and tenofovir and monitored for tolerability,     toxicity, compliance, changes in viral RNA load and disease response.   "
134157|NCT01528852|"     In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine     cleansing solution on umbilical cord of infants in first 10 days of life results in        -  Reduction in neonatal mortality (deaths in first 28 days of life)        -  Reduction in umbilical cord infections (defined by moderate or severe redness of the          cord) during first 28 days of life        -  Reduction in umbilical cord infections (defined by pus formation with any degree of          redness) during first 28 days of life.      The double blind part of study uses a control preparation without chlorhexidine (CHX) as     control group while in the sub-study dry cord care group is also evaluated as second control.     Hypothesis is that CHX group will have lower mortality and umbilical cord infections while     control group and dry cord group will be similar as shown in a previous study in Nepal.   "
134158|NCT01528839|"     There is growing evidence that thyroid axis dysfunction may contribute to the pathophysiology     of bipolar illness. Open-label studies have consistently demonstrated that the behavioral     expression of bipolar disorder can be modified by a change in thyroid status, and in many     instances the course of illness is improved through the use of adjunct thyroid hormone     treatment. Recent evidence emerged from acute intervention studies that add-on treatment with     supraphysiological doses of levothyroxine is an effective augmenting agent in patients with a     major depressive episode. The primary goal of this international multicenter trial (5 sites)     is to determine in a 13-week, randomized, placebo-controlled design (1 week single-blind     placebo run-in, 6 week double-blind, 6 week open-label) the efficacy and safety of add-on     treatment with levothyroxine (300 mcg/d) in combination with mood stabilizer/antidepressant     therapy in the treatment of patients with bipolar depression. The main hypotheses is:     treatment with levothyroxine will result in a significantly greater mean reduction of HRSD     total score and in a higher number of responders and remitters compared to placebo treatment.     This proposal will build on our pilot data and provide evidence for the use of levothyroxine     as an effective augmentation strategy in the treatment of bipolar depression.   "
134159|NCT01528826|"     The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus     oxaliplatin in pretreated metastatic triple-negative breast cancer.   "
134160|NCT01528813|"     The study aims to investigate the effectiveness of a single application of Er:YAG laser to     the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of     onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial     respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a     kind of onychomycosis that does not affect the ungual matrix). The patients will receive     treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment     by means of the clearance of nail plate infection.   "
134161|NCT01528800|"     The purpose of this study is to see if vitamin K supplementation three times per week reduces     the progression of coronary artery calcification over 12 months in dialysis patients compared     to placebo?   "
134162|NCT01528787|"     In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized     to receive Netarsudil (AR-13324) Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle     (one eye), q.d. (AM) x 7 days. The first dose and last dose will be administered in the     clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic     throughout the study.   "
134163|NCT01528774|"     The purpose of this study is to determine if circulating tumor cells (CTC) can be accurately     detected and isolated from the blood of participants with melanoma using novel laboratory     techniques. Blood samples will be collected from participants with melanoma, and also from     participants with other solid tumor cancers and healthy volunteers for purposes of     comparison.      Relevant information will be collected from participant's medical record and stored in a     coded manner in a password-protected format. This information will be used to look for     correlations of research results on blood samples to participant's medical condition. Test     results will not be given to participants or their physicians. In some cases, CTC may be     grown for long-term cell lines for further research.   "
134164|NCT01528761|"     The purpose of this 12-month study is to compare how well two programs help older adults make     physical activity a regular habit.   "
134165|NCT01528748|"     This study examines the effectiveness of Cognitive Behavioral Analysis System of     Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults     who are chronically depressed and alcohol dependent.   "
134166|NCT01528735|"     The objective of this trial is to investigate tolerability, safety, pharmacokinetics and     antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks     in Japanese treatment-naive patients with chronic GT-1 HCV infection.   "
134167|NCT01528722|"     Laparoscopic cholecystectomy (removal of the gall bladder via 'keyhole surgery') is a common     procedure. This can be performed as an emergency operation when a patient has a complication     of gall stones such as acute inflammation or pancreatitis. There are several trials which     demonstrate that placing local anaesthetic inside the abdomen at the site of gall bladder     surgery during a planned elective operation decreases post operative pain. This is the first     trial to investigate the efficacy of this local anaesthetic during emergency cholecystectomy.   "
134168|NCT01528709|"     During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to     bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein     bypasses themselves develop blockages over time, a process termed saphenous vein graft     disease. By lowering cholesterol levels in the blood, statin medications are used after     surgery to prevent the development of atherosclerotic blockages in the vein bypasses.     Recently, higher doses of statin medications have been introduced, with some studies showing     that they are more effective than traditional doses when used in heart attack patients.     Furthermore, laboratory tests have shown that higher doses of statin medications can slow the     development of atherosclerosis. Despite these benefits, very little is known regarding the     use of high-dose statin therapy after bypass surgery in humans.      The goal of this study will be to see if high-dose statin therapy will prevent the     development of vein graft occlusion during the first year after bypass surgery. Patients will     be randomized to receive either high-dose statin therapy or conventional moderate-dose statin     therapy starting within 4 days of surgery and continuing for the duration of one year after     the operation. The statin medication will be given in capsule form. During the course of this     study, neither the patient nor the health care team will know which treatment each patient is     receiving. One year after bypass surgery, a computed tomography (CT) coronary angiogram will     be performed to evaluate the patency of the vein bypasses.   "
134169|NCT01528696|"     Obese patients undergoing cesarean section are at high risk for wound complications, which     occur in approximately 20% of patients. This is a randomized controlled trial designed to     determine whether the risk for wound-related complications can be reduced by covering the     incision with a silver-impregnated dressing in the postoperative period.   "
134221|NCT01528007|"     The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as     combined with CBT-intervention in the treatment of pathological gambling (PG). The study     period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to     participate to this placebo-controlled double-blind trial.   "
134170|NCT01528683|"     Treatment standard for patients with rectal cancer depends on the initial staging and     includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III     tumors, radiochemotherapy should be performed in addition to surgery, preferentially as     preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in     surgical approaches, especially the establishment of the total mesorectal excision (TME) in     combination with sophisticated radiation and chemotherapy have reduced local recurrence rates     to only few percent. However, due to the high incidence of rectal cancer, still a high     absolute number of patients present with recurrent rectal carcinomas, and effective treatment     is therefore needed.      Carbon ions offer physical and biological characteristics. Due to their inverted dose profile     and the high local dose deposition within the Bragg peak precise dose application and sparing     of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an     increase relative biological effectiveness (RBE), which can be calculated between 2 and 5     depending on the cell line as well as the endpoint analyzed.      Japanese data on the treatment of patients with recurrent rectal cancer previously not     treated with radiation therapy have shown local control rates of carbon ion treatment     superior to those of surgery. Therefore, this treatment concept should also be evaluated for     recurrences after radiotherapy, when dose application using conventional photons is limited.     Moreover, these patients are likely to benefit from the enhanced biological efficacy of     carbon ions.      In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy     for recurrent rectal cancer will be determined in the Phase I part, and feasibility and     progression-free survival will be assessed in the Phase II part of the study.      Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied.      The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II     part its progression-free survival.   "
134193|NCT01528371|"     Intravenous sedation was used for dealing with transient hypertension, so-called white-coat     hypertension, before dental treatment. Midazolam used as a sedative also has antianxiety     effect, and the mechanism is guessed that it minimizes patients' stress, resulting in the     stability of blood pressure. The purpose of this randomized controlled trial (RCT) is to     evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in     white-coat hypertensive dental patients.   "
134171|NCT01528670|"     The purpose of this clinical study is to investigate the clinical feasibility and     effectiveness of off-line Positron-Emission-Tomography (PET) quality assurance for promoting     the accuracy of proton and carbon ion beam therapy. One main clinical advantage of ion     therapy over conventional radiation therapy is the excellent conformation of the delivered     dose to the tumour volume while well sparing the surrounding healthy tissue. However,     clinical exploitation of this potential to the maximum extent requires in-vivo validation of     the actual treatment delivery and, in particular, of the ion beam range within the patient.     Since the primary ions are completely stopped in the target volume as opposed to photon     radiation, no conventional quality assurance techniques like transmission electronic portal     imaging can be applied to monitor ion beam therapy. Hence, ion treatment planning currently     relies on models and experimental data accurately validated in tissue-equivalent targets, but     no direct verification of the actual treatment delivery and of the ion beam range within the     patient is possible in standard clinical practice.      At present, PET offers the unique possibility to monitor the precision of ion irradiation     in-vivo and non-invasively. The method is based on the detection of the b+-activity which is     formed as a by-product of the irradiation, i.e. without administration of radio-tracers to     the patient. A positive clinical impact of in-beam (i.e. during the irradiation) PET     monitoring has been demonstrated for carbon ion therapy in the pilot project at GSI     Darmstadt, Germany, and promising clinical data of post-radiation PET/CT imaging have been     recently reported for passive proton beam delivery in USA and Japan. Therefore, a pilot     clinical study is hereby proposed at the Heidelberg Ion Therapy Center in order to 1) assess     the applicability of post-radiation PET imaging to scanned ion beam delivery, 2) identify the     patient population which may benefit from it and 3) extract population-based information on     the reliability of the beam range in different tumour locations for all the ion species     clinically available at HIT.      The investigated patients are expected to benefit from this study, since in case of detected     deviations between planned and actual treatment delivery a proper correction could be applied     in the next irradiation fraction, assuring an overall better treatment than without any     monitoring. Moreover, site-specific patient-population information on the ion range precision     at HIT might enable improvement of the CT-range calibration curve as well as safe reduction     of the treatment margins to promote enhanced treatment plan conformality for full clinical     exploitation of the promises of ion beam therapy.   "
134172|NCT01528657|"     The objective of this study is to intra-individually compare the performances of two     pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic     Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare     ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of     atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted     with a pacemaker for Sick Sinus Syndrome.   "
134173|NCT01528644|"     Iron deficiency anaemia affects around two billion people worldwide. Food fortification with     iron is a realistic way to combat this problem. Water soluble forms of iron are considered to     be more bioavailable than nonsoluble iron compounds. However, the former often cause sensory     problems when added to foods, while the latter cause fewer problems but are not generally     well absorbed and are therefore ineffective as fortificants. A potential strategy for     overcoming this problem is the use of water soluble iron compounds protected by a water     resistant barrier, which will prevent potential organoleptic changes within fortified foods     and protect the iron (from oxidation) through the digestion process thus increasing its     availability. The investigators will use alginate, in the form of alginate beads, as a     protective barrier for soluble iron gluconate. It has been shown that alginates bind divalent     and trivalent cations and therefore may be a useful vehicle for soluble iron compounds to     fortify foods.      The aim of this project is to measure the effect of alginate on iron absorption from ferrous     gluconate and assess the potential modulating effect of calcium on iron absorption in the     presence and absence of alginate.   "
134174|NCT01528631|"     The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to     sucrose in men.   "
134175|NCT01528618|"     The present study will be a randomized, control, multicenter phase III study of recurrent or     metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and     cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists     of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical     radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side     effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.   "
134176|NCT01528605|"     This study is to investigate the protective effects of supplemental lutein and zeaxanthin on     early age-related macular degeneration (AMD) patients in China.   "
134177|NCT01528592|"     Based on studies showing better responsiveness of motor versus cognitive symptoms to     Parkinson's Disease medication, also known as dopaminergic treatments, the investigators     hypothesize that comparison of resting state networks in the on versus off medication state     in Parkinson's Disease patients will show greater effects on brain networks associated with     motor control.   "
134186|NCT01528462|"     The aim of the investigators was to determine whether the immediate management of any     detected sleep disorders can improve outcomes in patients who have had a transient ischemic     attack (TIA) or minor stroke. This group of patients is at high risk for having a recurrent     stroke or TIA, and the investigators would like to investigate new ways of preventing     potentially avoidable events. The treatment of sleep disorders immediately after a stroke or     TIA may prove to be a novel method of avoiding future strokes and improving outcomes.   "
134178|NCT01528579|"     Background:      Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated     Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and     personal sufferings there are only a few prospective randomized studies (RCT) in patients     with chronic WAD, and none of them evaluating return to work, or the role of neck specific     exercises with or without a combination of a behavioral approach compared with prescribed     physical activity.      Aim:      The general aim of this RCT is to examine what neck-specific training with or without a     combination with behavioral approach adds to prescribed physical activity of persons with     chronic WAD with regard to pain intensity, physical and psychological function, health care     consumption and return to work. Another aim is to study predictive factors of importance for     a good outcome of rehabilitation.      Method:      After informed consent patients in age 18-63 years of age with WAD II-III with more than 6     months duration will be randomized to one out of the three alternatives of physiotherapy,     treatment with medical exercise therapy with neck specific exercises (A),treatment with a     behavioral approach combined with neck specific exercises (B), prescribed physical activity     (C). Randomisation will be done by the central project leader. 200 patients will be included     in the study. All physiotherapists engaged in the structured and well described treatment     will be introduced in the program by the project leader. The measurements with good     clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24     months after inclusion into the study. Clinical measurements will be performed by a blinded     investigator. Background data, disease-specific and generic data will be measured by     self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected     from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck     specific disability and return to work. Cost-effectiveness will be calculated.   "
134179|NCT01528566|"     This is the first study to test the effect of Tai Chi on pain from knee osteoarthritis in     community-dwelling elders with mild cognitive impairment. If Tai Chi is effective in reducing     pain, clinicians can use it routinely with this population; then elders can maintain their     functional ability longer, and perhaps delay or prevent long-term care admission, and the     investigators can save health care dollars.   "
134180|NCT01528553|"     In children with excessive knock knees it may be necessary to use guided growth (small     surgical procedure) so the child outgrows the condition before maturity. A new implant is on     the market and the investigators compare this implant (8plate) with the old technique     (staples) in a randomised setup.      The hypothesis is that the 8plate provides a faster correction rate and that this treatment     is superior to stapling.   "
134210|NCT01528150|"     The purpose of this observational study is the assessment (safety and efficacy) of the St.     Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™     System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population     includes patients with a standard bradycardia pacing indication.   "
134181|NCT01528540|"     Study hypothesis: Combination of antioxidants and pregabalin results in better pain relief     than placebo in patients with chronic pancreatitis.      Chronic pancreatitis (CP) is a clinical enigma, with pain being the most distressing symptom     that brings the patient to clinical attention. Pain in chronic pancreatitis is     multifactorial, and may be related to pancreatic ductal hypertension, tissue hypertension,     inflammatory cytokines, oxidative stress and neuropathic mechanisms like mechanical     allodynia, inflammatory hyperalgesia and temporal summation. The mainstay of treatment for     pain in CP due to pancreatic ductal stone is endotherapy (ESWL and ERCP). Recent randomized     controlled trials have shown that antioxidant cocktail and pregabalin (a presynaptic voltage     gated calcium channel blocking agent) can result in significant reduction of pain in CP.      In this study, the investigators will study the efficacy of the combination of antioxidants     and pregabalin in reducing pain and compare that with placebo. The investigators will     randomize patients with documented chronic pancreatitis with recurrent/persistent pain after     undergoing endotherapy and ductal clearance into three groups: Group A- antioxidants +     pregabalin; Group B- Placebo. The primary outcome will be change in pain score and the     secondary outcomes will be change in the number of painful days, analgesic requirements,     quality of life and depression scale. Pain score will be quantified by the Izbicki pain score     and visual analog scale; while quality of life and depression will be measured by the EORTC     QLQ-C30/PAN26 and Beck depression inventory respectively. Comparison between Group A vs B     will be made by the Chi square test/Fischer Exact and the Student's 't' tests respectively     and analysis will be done on a intention to treat and per protocol basis. With an expected     improvement of pain by 40% (at 80% power and alpha of 0.05) and adjusting for a presumed 10%     drop out rate, the required sample size in each group will be at least 40.   "
134182|NCT01528514|"     It is well-established that myocardial infarction (MI) associated with coronary artery bypass     graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective therapies     to limit myocardial injury after CABG are lacking. Previous studies have shown that     curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery and     decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion injury     in animal models. The investigators aim to evaluate whether curcuminoids prevent MI after     CABG, compared to placebo.   "
134183|NCT01528501|"     This is an open-label, phase II trial evaluating the antitumor activity and safety of the     oral Histone Deacetylase (HDAC)-Inhibitor LBH589. The treatment consists of 20 mg LBH589     three times a week in patients with chemo-refractory HDAC overexpressing.      metastatic adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett     carcinoma). One cycle lasts 21 days. A total of 28 patients will be enrolled in this trial.     In patients experiencing LBH589-related toxicity requiring treatment rest or dose reduction     dose may be reduced. Subsequent dose adjustment will be permitted based on outcome. Treatment     will continue until disease progression or intolerable adverse events. Subsequently, the     patients will be followed-up for one year.   "
134184|NCT01528488|"     The epidermal growth factor receptor (EGFR) has become an important target for cancer     therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an     important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with     the encouraging efficacy in NSCLC is the common side effects, of which the most common one is     the specific papular and pustular acne-like rash which affects mainly the face, scalp, and     upper torso. But till now, no medicament has been proved effective enough to treat or prevent     the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable activity     at the rash prevention in our preliminary study, so the investigators conduct the randomized,     double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC® Calming Skin     Spray in prevention of EGFR-TKIs associated rash in NSCLC.   "
134185|NCT01528475|"     This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of     therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional     post-resuscitation care. The goal of this trial is to increase the proportion of cardiac     arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to     reach the target body temperature within 6 hours of hospital arrival. The investigators     believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians     to continue therapeutic hypothermia, and will lead to care improvements across a health     system.   "
134187|NCT01528449|"     Both prospective and retrospective (look back) study of blood donors for laboratory evidence     of babesia microti infection.      Two laboratory methodologies will be utilized:        1. - PCR, to look for the presence of B.microti in whole blood        2. - IFA, to look for significant titers of B.microti antibody   "
134188|NCT01528436|"     This randomized controlled study aims to evaluate the efficacy of umbilical cord blood     therapy for children with cerebral palsy.   "
134189|NCT01528423|"     The research is intended to evaluate the short-term reproducibility of the XtremeCT device     for measurements of peripheral bone density and bone structure in population-based volunteers     from different age groups and to compare the XtremeCT with current peripheral quantitative     computed tomography (pQCT) technology. The investigators will also assess the correlation     between XtremeCT measurements of bone structure with hormones and biochemical markers of bone     turnover.   "
134190|NCT01528410|"     This is a multicentre, open, randomised, and controlled trial conducted in sixty (60)     patients diagnosed with refractory or recurrent ascites. Patients will be randomised     (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm     B-standard of care with evacuation large volume paracentesis. The main aims of the study are     to determine the paracentesis free survival, defined as the time to the first large volume     therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of     cirrhosis-related complications in the group of patients randomized to the ALFApump system     group, as well as nutritional effects, resource utilisation, patient quality of life and     survival non-inferiority.   "
134191|NCT01528397|"     A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory loss     which can result in functional disability. This article reports the treatment of the thumb     PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN. Fourteen     patients with the thumb PDN defect underwent a new surgical procedure in which the pedicled     nerve graft was used to bridge nerve defect. For comparison, the investigators also collected     a consecutive series of 21 patients with thumb PDN defects treated using a nonvascularized     sural nerve graft. This study was designed to evaluate the efficacy of pedicled nerve     grafting for PDN defects in the thumb.   "
134194|NCT01528358|"     Hypotheses:        1. In the acute phase of early illness, tissue oxygen saturation and vascular occlusion          test (VOT) are important adjuncts in differentiating severe critical illness requiring          ICU admission from patients benefiting from less aggressive therapies (non-ICU          admission).        2. An early feature of severe sepsis is abnormal microcirculatory vasoreactivity.        3. Microvascular reactivity can be measured by means of vascular occlusion test (VOT) using          non-invasive near infrared spectroscopy (NIRS) to measure tissue Oxygen saturation          (StO2).        4. Microvascular reactivity is significantly deranged in patients with early severe sepsis          and is quantifiably different from non-septic critically ill patients.        5. Other measures of microcirculatory perfusion ie. sublingual orthogonal polarization          spectral (OPS) video microscopy, are abnormal and will directionally correlate with VOT          and StO2 in severe sepsis        6. In severely septic patients response to therapy can be assessed by VOT and StO2          monitoring and will correlate with prognosis.        7. A management protocol incorporating VOT and StO2 monitoring in addition to conventional          hemodynamic and biochemical parameters as a guide to therapy will result in improved          outcomes in severely septic patients.      This project will investigate the use of a non-invasive near infrared light (NIR) device in     conjunction with brief arm compression to measure the microcirculation in critically ill     patients. It is know that in patients with overwhelming infections, their blood vessels do     not respond normally and the NIR device can help measure how abnormal their blood vessels     are. This type of testing is non-invasive and can be performed repeatedly without harm to the     patient and may provide an earlier way to determine whether they have overwhelming sepsis and     also may help to optimize the treatments they receive and better tailor their treatments to     the degree of blood vessel abnormalities that are found. If our hypotheses are correct, this     simple non-invasive test could provide a very rapid means of assessing patients that could be     done more safely and quickly than some of the current methods. This would have an important     effect to enhance patient safety and improve outcomes in such critically ill patients.   "
134195|NCT01528345|"     This trial is designed to enroll postmenopausal patients with locally advanced or metastatic,     HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy,     and whose disease has progressed on or after prior endocrine therapy.      Patients must undergo molecular pre-screening prior to entry.   "
134196|NCT01528332|"     The purpose of this study is to determine if the Pain Relief Patch, which shines light of a     limited wavelength on the painful area of the back, relieves chronic musculoskeletal back     pain. At the same time, this study will gather information on side effects associated with     use of the Pain Relief Patch. The study will compare the Pain Relief Patch to a patch that is     similar in appearance, but which shines a different, presumed nontherapeutic, wavelength of     light.   "
134197|NCT01528319|"     To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation     of shoulder   "
134198|NCT01528306|"     This is a pilot study designed to see if HP802-247, an investigational treatment with living     human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis     Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also     be assessed.   "
134199|NCT01528293|"     This is a prospective, randomized, comparative interventional human subject trial. Patients     with a chronic venous ulceration of the lower extremity will be enrolled into this study.     These wounds must be recalcitrant to the standard treatment regimen. There are a total of two     arms in this study. One group will be randomly assigned to receive Vacuum Assisted Closure     (V.A.C. or VAC) by means of the ActiV.A.C. + Compression therapy group consisting of the     application of this device along with compression therapy. The other group will be randomly     assigned into compression therapy only group. A total of 60 subjects will be enrolled into     this 6 week study. There will be a 2 week run-in period (prior to the onset of the     intervention) to ensure that the wound has not healed greater than 35% prior to intervention     and randomization. Wounds that heal within the 6 week trial period will have an additional     confirmatory visit 2 weeks after healing was identified.      If within the 6 week intervention period the wound bed is determined to be ready for a Split     Thickness Skin Graft (STSG) or Bio-engineered Alternative Tissue (BAT), the surgery or clinic     application will be scheduled within 4 weeks. Subjects deemed not to be a surgical candidate,     will have Bio-engineered Alternative Tissue (BAT) application in the clinic. This includes     patients who are medically unstable to receive a medical clearance for surgery or otherwise     not a candidate for Split Thickness Skin Graft (STSG) surgery (e.g. donor site skin is     compromised). During this period between the scheduled STSG surgery or BAT application, the     subjects will continue within the assigned treatment group. A confirmatory visit will also     occur 2 weeks after the application of a Split Thickness Skin Graft (STSG) or Bio-engineered     Alternative Tissue (BAT).      Patients diagnosed with a chronic venous ulceration will be assessed for study eligibility     during their initial clinical evaluation. Patients who meet the eligibility requirements will     be asked to enroll into the study (see Subject Recruitment). Subjects will be asked to sign     the informed consent form and receive a copy of the informed consent.   "
134200|NCT01528280|"     The purpose of this study is to access whether shift workers (morning, afternoon or night)     vaccinated against hepatitis A would have some humoral and cellular response impairment.   "
134201|NCT01528267|"     The prupose of this study is to determine the feasibility, effectiveness, and safety of     injecting blood into the airways to cause lung volume reduction in people with severe     emphysema.   "
134202|NCT01528254|"     The purpose of this study is to determine whether the initiation of a vildagliptin plus     metformin combination regimen would result in more durable glycemic control than metformin     monotherapy in treatment-naïve patients with T2DM.   "
134203|NCT01528241|"     This study is designed to characterize the regional distribution of [11C] ABP688 in brain by     positron emission tomography (PET).   "
134204|NCT01528228|"     Following standard of care procedures for arthroscopy knee surgery it is anticipated that     Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and     improve functional outcomes.   "
134207|NCT01528189|"     Despite improvements in surgical techniques and perioperative care, the high incidence of     postoperative surgical site infections remains a major problem in patients undergoing major     abdominal surgery (liver, pancreatic and colorectal surgery).      Using the hyperinsulinemic-normoglycemic clamp technique, i.e. continuous infusion of insulin     combined with dextrose titrated to clamp blood glucose between 4 and 6 mmol/L, we     successfully established and preserved normoglycemia during the perioperative period. Our     objective of this study is to determine if the maintenance of perioperative normoglycemia by     a hyperinsulinemic normoglycemic clamp reduces the rates of incisional and space/ surgical     site infections following abdominal surgery (liver, pancreatic and colorectal surgery).   "
134208|NCT01528176|"     To determine whether or not chronic kidney disease (CKD), stages III—V and ESRD , is     associated with altered vitamin D metabolism related to fibroblast growth factor-23 (FGF-23)     stimulation of Cyp24 and whether they have resistance to elevations of 25 Hydroxyvitamin D     (25(OH)D3) after cholecalciferol supplementation.      To determine if such resistance is related to enhanced catabolism of (25(OH)related to     elevated levels of FGF-23.   "
134209|NCT01528163|"     In this clinical trial, the investigators want to know if cabazitaxel is more effective than     methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head     and neck in palliative treatment.   "
134212|NCT01528124|"     This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and     tolerability of the study drug in healthy people and investigate how much of the study drug     gets into the blood stream and how long it takes the body to get rid of it. Information about     any side effects that may occur will also be collected.   "
134213|NCT01528111|"     This Phase 1/2a study is intended to assess the safety, tolerability, and effects on     intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered     topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular     hypertension.   "
134214|NCT01528098|"     The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus     bisacodyl versus PEG alone for bowel preparation in hospitalized patients.   "
134215|NCT01528085|"     The goal of this trial is to evaluate the efficacy and the tolerance of the combination of     nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy     in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a     common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be     used in this trial with the addition of nilotinib as concomitant therapy during induction,     consolidation and maintenance. The patients will be prospectively monitored for minimal     residual disease and bcr-abl tyrosine kinase domain mutations.   "
134216|NCT01528072|"     The purpose of this study is to assess the safety and fusion rates following posterior     lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to     literature control.   "
134217|NCT01528059|"     Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be     varied by different gastric-small intestine reconstruction used in the procedure. There are     reports that Roux en Y reconstruction may give a better result. The purpose of this study is     to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid     with type 2 diabetes.   "
134218|NCT01528046|"     H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator,     but will not be recruiting locally.      The purpose of this study is to evaluate the tolerability and safety of escalating doses of     metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with     recurrent and refractory solid tumors.   "
134219|NCT01528033|"     This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate     the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical     abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous     tissue that permeates the internal organs must be intact.      Main outcome measure is the time until complete wound closure that sustained for a minimum of     14 days. Furthermore the therapy options will be examined regarding several other clinical,     safety, patient reported and economic parameters.      Patients will be assigned equally and by chance to both treatment groups. Study participants     as well as the attending doctors and nurses will be informed about the assignment to the     respective treatment arm.      The primary outcome measure and some of the secondary parameters like reappearance of the     wound and the development of the wound size over time, examined within an active study     treatment time of 42 days, will be photographed and analysed under the use of a central     computer system. The central analysing personal will not be informed about patient details or     therapy allocation.      Patients with at first closed belly wounds with wound healing disorder in the postoperative     course after surgery without an opening of the underlying layer of fibrous tissue are     eligible to be included in the trial if the diagnosis of a wound healing impairment in the     postoperative course is manifested as a wound with spontaneous dehiscence, a wound that     requires an active reopening of the suture by the treating physician or a wound that cannot     be closed by primary intention and requires further treatment to achieve permanent closure.      Study participants will be selected and enrolled within clinical surgical departments which     provide the respective personal, structural and scientific background for the conduction of     the trial project.      Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very     important to examine the therapy options also in the ambulant care setting thus study     participants with good health who are able to continue the specific wound treatment in     ambulant should be transferred to the ambulant service as soon as possible.   "
134220|NCT01528020|"     Suicide is the third leading cause of death among adolescents in the US yet there is a     paucity of research on effective treatments for this population. The primary aim of the     research described in this application is to evaluate the efficacy of dialectical behavior     therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal     adults of reducing the incidence, frequency and medical risk of suicide attempts and     non-suicidal self-injuries among individuals meeting criteria for borderline personality     disorder (BPD). While DBT is widely used in the community with suicidal adolescents,     particularly those with difficulties characteristic of BPD such as poor emotion regulation     and impulse control, no randomized trial of DBT with suicidal adolescents has ever been     conducted. And, while non-randomized trials indicate that the intervention is both safe and     effective, without a randomized trial the investigators simply do not know whether DBT for     suicidal adolescents is efficacious or not. Given the severity of the problem and the lack of     alternative treatments for high risk adolescents, addressing this question is of great     importance. The second aim of the research is to analyze mediators of reduced suicidal and     self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los     Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both     treatments include 6 months of individual and group treatment and adolescents and a parent     complete 5 assessments over a 1-year period.   "
134769|NCT01520818|"     This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control     of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30     treatment.   "
134222|NCT01527994|"     Current treatments for opioid addiction would benefit by the addition of a non-opioid based     treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1)     receptor is involved in opioid reward and withdrawal. This study proposes to study a     potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist     aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological     characteristics of opioid addiction, and what is known of the currently employed treatments,     the investigators propose that the therapeutic mechanism of any potential opioid addiction     treatment medication must include the ability to reduce opioid withdrawal. This is of     particular importance during treatment initiation (eg. detoxification). In addition, for     long-term treatment and relapse prevention, it is important to manage drug craving and     inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the     investigators propose to study aprepitant using human models of opioid withdrawal, craving     and acute opioid reward and reinforcement. The investigators will also include a     neuro-economics choice procedure paradigm.   "
134242|NCT01527734|"     The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose     comparison with a open-label, crossover, formulation comparison.   "
134224|NCT01527968|"     TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there     is no literature available comparing the two in total knee arthroplasty (TKA). The     investigators want to determine if TXA or EACA compared with placebo are effective and safe     for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.   "
134225|NCT01527955|"     The purpose of this study is to determine how effective Kelee meditation is in improving     stress, anxiety, and depression.   "
134226|NCT01527942|"     Bariatric patients usually require the use of either intravenous or oral opioid medications.     The use of opioids, however, is often associated with side-effects such as nausea, sedation     pruritus, urinary retention and respiratory depression with often delay patient discharge.     This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to     determine if this will decrease the use of opioids post-operatively for pain management in     morbidly obese patients undergoing laparoscopic bariatric surgery.   "
134227|NCT01527929|"     Primary Objective:      - To assess potential impact of moderate and severe renal impairment on the pharmacokinetics     of cabazitaxel      Secondary Objective:      - To assess the safety of cabazitaxel in patients with various degrees of renal impairment   "
134228|NCT01527916|"     This is an efficacy and safety study evaluating a new treatment for subjects with mild to     moderate Alzheimer's disease.   "
134229|NCT01527903|"     The purpose of this study is to compare propofol-remifentanil sedation with     midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in     the ICU, as well as the incidence of delirium. Primary end-points were weaning time and     extubation time, and secondary end-points were the incidence of delirium and length of stay     in the ICU.   "
134230|NCT01527890|"     In this retrospective study, the investigators examined incidence and risk factors of     postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous     patient-controlled analgesia (IV-PCA).   "
134231|NCT01527877|"     This study is to evaluate disease control rate (DCR) at 8 weeks of BKM120 administered as     therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma.   "
134232|NCT01527864|"     A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out.     Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control     group (PC+ placebo). The efficacy was evaluated every six weeks.Follow-up continued until     disease progression or death.   "
134233|NCT01527851|"     Introduction: Currently, bariatric surgery appears to be the most effective treatment to     improve the health of morbidly obese population. However, the massive weight loss induced by     this intervention can create excess loose skin in various parts of the body contributing to     the feeling of failure in their desire to feel better in some patients. Several studies show     that people are once again disappointed and dissatisfied with their body appearance due to     the mass of unsightly loose skin that disrupts their quality of life. However, very few     studies have focused on the barriers that this excess skin could create in everyday physical     activity. The aim of the investigators pilot study is to assess the impact of excess skin on     the practice of physical activity in women who underwent bariatric surgery and evaluate if     there is a relationship between physical activity and the level and location of excess skin.     Also, the investigators will explore, the benefits of plastic surgery in patients who had     this intervention.      Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had     subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss     post bariatric and plastic surgery, motivational stage on the practice of physical activity,     usual practice of physical activity, functional and physical ability, perceived benefits and     barriers of physical activity, self-esteem and quality of life will be assessed. After     analyzing the results, a group discussion will be established to further evaluate the impact     of excess skin on the practice of physical activity. The evaluation will be identical for     monitoring the effects of plastic surgery but the discussion group will also address the     benefits and satisfaction related to plastic surgery.      Expected results: Excess skin could be a barrier to physical activity by limiting the     functional and physical capacity. Thus, plastic surgery could improve the practice of     physical activity with a direct improvement of functional discomfort, the subjects'     motivation to be physically active, perceived benefits and barriers to physical activity,     self-esteem and quality of life.      Issue project: This pilot project will generate data that will allow us, depending on the     relevance of the results, to continue the investigators investigation with a larger cohort.   "
134234|NCT01527838|"     This trial is a prospective, open-label, single-arm trial of the safety of a single     FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity     conditioning regimen for hematologic malignancies. A maximum of 40 eligible adult subjects     will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.   "
134235|NCT01527825|"     The overall aim of this project is to evaluate the safety and immunogenicity of 3 different     dosing options of trivalent influenza vaccine (TIV) vaccination of HIV-infected pregnant     women: single dose, double dose (at same time point) and two-doses (1 month apart).   "
134236|NCT01527812|"     The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound     guided femoral nerve block using the following endpoints: circumferential spread, anterior or     posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for     operative fixation of fractured neck of femur.   "
134237|NCT01527799|"     The purpose of this study is to use comprehensive exercise testing to examine causes of     exercise limitation in children and young adults with sickle cell anemia.   "
134260|NCT01527500|"     The amendment is designed to test the safety and efficacy of lower and higher doses of     Intravitreal (IVT) LFG316 using single and 18 successive monthly injections in patients with     geographic atrophy (GA). The study will also provide information on the safety, tolerability,     serum concentrations and pharmacodynamics of single and multiple IVT doses of LFG316.   "
134238|NCT01527786|"     Postpartum depressed women suffer from functional impairment in their mood, thoughts,     cognition and physical well being leading to poor motivation, bonding difficulties, decreased     productivity, conflict and neglect. Moderate/ severe depression responds best to a     combination of antidepressants and counseling. This study will estimate the proportion of     women who return to functionality after treatment with Desvenlafaxine and examine the     differential impact of change in depression and anxiety symptoms on functionality over twelve     weeks. Depression and anxiety symptoms will be monitored through six mood questionnaires;     functional recovery will be monitored through a simple self-report questionnaire at each     visit.   "
134239|NCT01527773|"     TOPDOCS is a prospective cohort study including COPD patients from currently six study     centers in Switzerland. Patients with COPD GOLD stages I-IV will be enrolled and followed-up     annually for at least 3 years. Yearly assessments will include a detailed patient history,     quality of life and activity questionnaires, history of exacerbations, lung function,     measurements of exercise capacity, measurements of vascular function, exhaled breath analysis     and blood sampling. The overall objective of the project is to establish a meticulously     characterized cohort of COPD patients living in Switzerland in order to allow high quality     research on the pathogenesis, treatment and complications of COPD. The specific aim of the     project is to determine clinically relevant COPD phenotypes and biological factors     influencing vascular function in COPD patients.   "
134240|NCT01527760|"     To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential     Hypertension by conducting clinical trial in moderate hypertensive patients for a period of     six weeks.   "
134245|NCT01527695|"     This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or     female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a     clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20     patients to complete this study.The study will evaluate the effect of 8 weeks treatment with     AZD3241 on microglia activation as measured via PET examinations.   "
134246|NCT01527682|"     Objectives:      The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a     selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to     surgical procedures. Safety will be assessed, too.In the first version of the protocol 96     eyes were forecasted to complete the enrolment. The protocol was then amended and now to     complete the study 68 eyes should be included.   "
134247|NCT01527669|"     The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin     acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet     after single oral administration in healthy subjects.   "
134248|NCT01527656|"     This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence     of two formulations of biphasic insulin aspart 70 in healthy male subjects.   "
134249|NCT01527643|"     This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence     of two formulations of biphasic insulin aspart 50 in healthy male subjects.   "
134250|NCT01527630|"     This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence     of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.   "
134251|NCT01527617|"     The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical     trial is to investigate the potential antioxidant benefits of a cranberry beverage. The     investigators hypothesize the chronic consumption of this beverage will improve indices of     oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators     also hypothesize that these benefits will be particularly evident following an oral glucose     tolerance test.   "
134252|NCT01527604|"     The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to     determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve     biomarkers of inflammation in older, obese adults.   "
134253|NCT01527591|"     The purpose of this study is to determine the safety and long-term immunogenicity of the     13-Valent Pneumococcal Conjugate vaccine in children who are solid organ transplant     recipients.   "
134254|NCT01527578|"     The University of California, San Francisco (UCSF) Simons Variation in Individuals Project     (Simons VIP) is currently recruiting healthy controls for a study aimed at better     understanding autism spectrum disorder. The UCSF site of the Simons VIP is conducting     functional and structural imaging, neuropsychological evaluation, genetic testing, and     neurologic exams in healthy individuals to compare with findings in autism spectrum disorder.   "
134255|NCT01527565|"     This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence     of two formulations of biphasic insulin aspart 70 in healthy male subjects.   "
134256|NCT01527552|"     This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence     of two formulations of biphasic insulin aspart 50 in healthy male subjects.   "
134257|NCT01527539|"     This trial is conducted in North America. The aim of this trial is asses the long term safety     and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had     participated in the BIAsp-1237 trial.   "
134258|NCT01527526|"     Objective:      The purpose of this study is to determine the etiology of the weight increase in     Depot-medroxyprogesterone Acetate (DMPA) users.      Method:      Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users     of a non hormonal method follow for two years. Will be included only women who never used     DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of     corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their     control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance     of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with     ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic     alterations should elucidate the etiology, and the beginning of the sub clinical     cardiovascular disease should be shown/discarded with the arterial evaluation.   "
134259|NCT01527513|"     To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as     adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.   "
134261|NCT01527487|"     The investigators propose a randomized phase II study evaluating the pCR and toxicity     profiles of combination eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC)     as neoadjuvant therapy for locally advanced HER2-negative breast cancer.   "
134262|NCT01527474|"     This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as     monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of     the study will consist of an 8 week treatment phase. Treatment of eligible participants will     be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the     presence of depressive symptoms and side effects up to a maximum of 20mg/day.      Study objectives are:        1. to investigate the efficacy of escitalopram in the treatment of PPD.        2. to assess the effects of escitalopram on patients quality of life.   "
134263|NCT01527461|"     The purpose of this study is to show that dogs are able to detect cancer in sweat samples.     This potentially would be the base for developing a new efficient, non invasive and     inexpensive diagnosis tool of lung cancer.   "
134317|NCT01526733|"     The purpose of this study is to evaluate consistency of accelerated insulin absorption and     onset-of-action and shortened duration of action for bolus insulin infusions after     pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 [rHuPH20])     injection at the time of infusion set insertion compared to sham injection.   "
134264|NCT01527448|"     This is a 9-week single-centre, open-label, dose-escalating study evaluating the efficacy and     safety of Quetiapine XR given as monotherapy in the treatment of non-lactating, post-partum     women diagnosed with Bipolar II Disorder. Subjects will need to visit the study doctor up to     8 times over a period of 9 weeks.      During the study period, subjects will be receiving a treatment with Quetiapine XR. The     starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment     of quetiapine will determine whether the study doctor will increase the dosage of the     subject's quetiapine. If the study doctor increases the quetiapine during the study, the     maximum dosage allowable during the study is 300mg.   "
134265|NCT01527435|"     The purpose of this study is to evaluate the fact that 20 milligrams per day of oral     Zeaxanthin as a supplement to patients with Choroidal neovascularization (CNV) and exudative     age related macular degeneration (ARMD) undergoing combination therapy with intravitreal     Bevacizumab (Avastin), intravitreal Dexamethasone and PDT laser photocoagulation and improves     anatomic and visual outcome compared to patients not receiving oral Zeaxanthin. Study     patients will be taking AREDS(PreserVision) and multivitamins (Centrum Silver); in addition     one-half of the patients will receive 20mg of oral Zeaxanthin.   "
134266|NCT01527422|"     We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim     (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer     the chemotherapy courses every 2 weeks with the practical advantage of requiring only one     dose of PEG-filgrastim instead of daily doses of G-CSF.   "
134267|NCT01527409|"     The Objectives of this study is        1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of          participating in tailored program (Health Partnership Program) for 24 weeks        2. To evaluate the efficacy for quality of life, life satisfaction, health leadership,          anxiety, depression, impact of event, social support, cancer belief as a result of          participating in tailored program (Health Partnership Program) for 24 weeks        3. To assess the efficacy of such intervention compared with usual care in cancer patients   "
134268|NCT01527396|"     The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node     metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial     cancer.   "
134269|NCT01527383|"     This is a randomized, double-blind, placebo-controlled study to assess the safety and     tolerability of V212 when administered to adults with autoimmune disease.   "
134270|NCT01527370|"     This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults     in India.   "
134271|NCT01527357|"     The primary objective of the study is to demonstrate the superiority of Fibrocaps plus     gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects     with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery.      This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial     that will be conducted at clinical trial sites in the European Union and United States.   "
134272|NCT01527344|"     Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in     transplanted hearts which is a significant cause of morbidity and mortality. The broad     objective of this research study is to advance our ability to diagnose as early as possible     the presence of CAV and to non-invasively predict those patients at increased risk of CAV     with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging     technique using an optical analog of ultrasound with a resolution 10 times greater resolution     than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood     have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial     tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of     atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for     routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, Minnesota (MN) that     reach inclusion and exclusion criteria for the study will be approached on the day to get     informed consent to perform OCT, blood sampling and peripheral endothelial function testing.     The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT     versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with     absolute counts of EPCs and 3) with peripheral endothelial function scores.   "
134273|NCT01527331|"     The purpose of this study is to compare the decision making of hospitalized subjects with     advanced cancer having a verbal discussion about CPR compared to subjects using a video.   "
134381|NCT01525901|"     The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1)     treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene     deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection     under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name     Increlex for the treatment of children with short stature due to primary IGF-1 deficiency. It     is being used off-label in the current study and is not FDA approved, nor has it yet been     studied in humans for the treatment of SHANK3 deficiency.   "
134274|NCT01527318|"     Neutral Lipid Storage Disease With Myopath (NLSDM) is a disease caused by a defect in the     PNPLA2 gene encoding ATGL. Patients with NLSDM accumulate triglycerides and exhibit muscle     weakness, cardiac failure and hepatosteatosis. Most of these patients die at young age due to     cardiac failure. Not much is known about the underlying mechanisms, though recently it was     discovered that PPAR activation in ATGL-/- mice was impaired leading to decreased     mitochondrial function, lipid accumulation and cardiac failure resulting in death at young     age. Activation of PPARs, by treatment with fibrates rescued the phenotype and reduced     mortality rates in these mice. These findings may have a major impact for patients with NLSDM     if these results can be translated to humans. Therefore, the investigators would like to     evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac     function in patients with NLSDM.      Patients will be treated with fibrates during a period of 28 weeks. Baseline measurements     will be performed prior to the study and after treatment. Cardiac and muscular lipid     accumulation, cardiac function, mitochondrial function and insulin sensitivity will be     assessed during these baseline measurements.   "
134275|NCT01527305|"     The purpose of this study is to evaluate the effectiveness and safety of paliperidone     palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute     schizophrenia (that is within past 4 weeks).   "
134276|NCT01527292|"     The purpose of this study is to determine pain control rate (Percentage of patients in each     arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months     post-treatment.   "
134277|NCT01527279|"     The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial     was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation     during observation sinus rhythm.   "
134374|NCT01525992|"     In this study the investigators aim to evaluate the impact of a community pharmacy-based     program to educate type 2 diabetic patients about medications, life style and self-care.   "
134278|NCT01527266|"     Several studies have reported that carbohydrate (CHO) ingestion can improve performance     during exercise of short duration (less than 60 min). However, there is no apparent metabolic     explanation for this observation because endogenous CHO stores should not be a limiting     factor during short duration exercise. Nonetheless, several groups have attempted to     investigate CHO administration during short duration exercise with varying results. When CHO     was administered intravenously, no performance effect was observed despite greater plasma     glucose availability (5). Therefore, it was suggested that during exercise of short duration,     exogenous CHO ingestion may exert its ergogenic effect by action through the central nervous     system, possibly mediated by glucose receptors in the mouth. The latter has been investigated     using a CHO-mouth rinse, whereby the CHO solution is spat out to remove any influence of the     gut on exogenous CHO oxidation or performance. Using this rinse, studies have demonstrated     results both for (5, 16), and against (1, 19) any improvement in short duration exercise     performance when compared with a placebo. The discrepancy in the findings may be due to     testing subjects in the fed (1) or fasted-state (5), when liver glycogen stores may be     compromised. However, no study has tested subjects in both the fasted and fed-state using a     CHO-mouth rinse. It remains to be determined whether CHO-mouth rinse is only effective at     improving short duration exercise performance when subjects are in the fasted, compared with     the fed-state. The investigators will test the hypothesis that CHO-mouth rinse improves     performance in the fasted-state only compared with a placebo-rinse.   "
134279|NCT01527253|"     The study evaluates the effect of a diet combining two different functional concepts on     markers associated to cardiometabolic risk. The functional concepts are selected on the basis     of their reported ability to influence the inflammatory tonus. It is hypothesized that the     medium-term consumption of a diet combining low GI-prebiotic foods may positively influence     various biomarkers associated with the risk for developing metabolic syndrome and     cardiometabolic disease. Also, the combination of functional mechanisms are expected to     result in synergistic effects.   "
134280|NCT01527240|"     The main objective of this study is to determine whether a single injection of CsA after     intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day     30 ± 15 assessed with Flair MRI.      Secondary objectives are to determine whether a single injection of CsA after intravenous     thrombolysis is safe and effective regarding to death and disability.   "
134281|NCT01527227|"     The research will examine effects of personal, familial, societal and intergenerational     characteristics on parentification, the effects of parentification on the quality of life of     the child and what encourages a better quality of life. This research will include 130     children between the ages of 10-18 who live with at least one parent who struggles with     serious mental illness in a comparison to 130 children of the same socio-demographic     characteristics raised by parents from a non-clinical population. The differences between     these two populations with regard to parentification, quality of life, social support and     fairness will also be examined. The parents and the children will fill out questionnaires.     The research group will be recruited from rehabilitation services, mental health clinics,     psychiatric hospitals and social welfare departments with sampling method. The comparison     group will be recruited from schools. This research broadens the knowledge of the causes and     the repercussions of parentification among children of parents who struggles with serious     mental illness in comparison with children raised by parents from a non-clinical population.     Few studies have examined children of the mentally ill in Israel, and there are none which     examined parentification.   "
134294|NCT01527045|"     This phase II trial studies how well donor atorvastatin treatment works in preventing severe     graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC)     transplant in patients with hematological malignancies. Giving low doses of chemotherapy,     such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer     cells and may also prevent the patient's immune system from rejecting the donor's stem cells.     The donated stem cells may replace the patient's immune cells and help destroy any remaining     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can     also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to     the donor before transplant may prevent severe GVHD.   "
134403|NCT01525615|"     The primary objective of this study is to compare the effects of orally inhaled tiotropium +     olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after     12 weeks of treatment in patients with COPD.   "
134282|NCT01527214|"     Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted     through General Practice, sadly it tends to take a relatively long time from first time the     patient is seen by their General Practitioner and until they are diagnosed. LC symptoms are     common, but usual because of benign diseases. Only 33% of LC patients presenting with alarm     symptoms. On average a General Practitioner in Denmark sees only one patient with newly     diagnosed lung cancer a year and the doctor will therefore get the clinical experience that     when they refer a patient, test often come out negative and they therefore fail to refer and     delay will increase - with a poorer prognosis as a result. Centrally in the diagnosis is     conventional chest X-ray, which unfortunately is inefficient in many cases, while CT scanning     has proven effective even for small tumors.      Hypothesis and aims: The project has three main hypotheses to be tested 1) the GP's use of     cancer fast-track and detection of suspected lung cancer can be optimized in relation to     interpretation of symptoms and subsequent referral practices and radiological investigation.     2) General Practitioners with special training can change the referral routines and 3) direct     access to fast CT scanning leads to earlier diagnosis of lung cancer.      Methods: The first part of the study is a register-based study of lung cancer patients' road     to diagnosis, based on a database of newly diagnosed cancer patients in a year. Second part     of the study is a clinical, randomized study of the effect of referral directly to fast chest     CT scan. Primary endpoint is delay, secondary endpoints are referral pattern (use of     fast-track packet), primary use of CT and 1-year mortality. Furthermore side effects,     including patient groups with increased delay.      The study will contribute new knowledge to the way GP's interpret symptoms, the way they     refer their patients when they suspect cancer, their use of diagnostic imaging and cancer     fast-track pathways. It will then provide a unique opportunity to create the necessary     knowledge about the effects of direct referral to fast CT scan and it might be a decision aid     whether to open for direct CT scan in General Practice for a group of patients.   "
134283|NCT01527201|"     The purpose of this randomized controlled trial is to determine the effectiveness of treating     cartilage lesions found during knee arthroscopy.   "
134284|NCT01527188|"     The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite     (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score     during the allergen chamber challenge before and after 6 months of treatment.   "
134285|NCT01527175|"     The subclavian vein (SCV) is often the preferred site for central venous access.     Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC)     approach have been proved to be useful in children. The investigators compared the success     rate, number of attempts, time tocatheterization, and complication.   "
134286|NCT01527162|"     This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day     walking activity and life participation of ambulatory children with cerebral palsy. The     investigators propose that SAFO have not effect on levels of walking and life participation     versus not wearing the SAFO.   "
134302|NCT01526928|"     Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI)     that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while     sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK)     and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or     recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of     rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.   "
134287|NCT01527149|"     This phase II trial studies how well ofatumumab in combination with cyclophosphamide,     doxorubicin hydrochloride, vincristine sulfate, and dexamethasone alternating with ofatumumab     in combination with cytarabine and methotrexate works in treating patients with newly     diagnosed mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, may     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, dexamethasone,     cytarabine, and methotrexate, work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Giving ofatumumab together with alternating regimens of combination chemotherapy     may kill more cancer cells.   "
134288|NCT01527136|"     This phase I trial studies the side effects and best dose of entolimod in treating patients     with locally advanced or metastatic solid tumors that cannot be removed by surgery.     Biological therapies, such as entolimod, may stimulate the immune system in different ways     and stop tumor cells from growing.   "
134289|NCT01527123|"     This is a Phase 1, single-center, open-label study to evaluate the pharmacokinetics of the     BPO metabolites benzoic acid and hippuric acid with 7-day repeat application of GSK2585823 in     subjects with acne vulgaris   "
134290|NCT01527110|"     This study will be an open-label, multi-center, single arm study to evaluate the safety and     efficacy of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with     laboratory confirmed influenza infection.   "
134291|NCT01527097|"     Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may     be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and     involvement of cells of the immune system. Atherosclerosis is frequently treated by statins     (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce     inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis     skin disease.      The current study aims are to evaluate whether a strong statin named Atorvastatin can improve     psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if     the activity of these two diseases are related to levels of common inflammatory biomarkers     (substance in blood) and whether Atorvastatin can change their levels.   "
134292|NCT01527084|"     1. To determine the appropriate timing of surgical intervention after Percutaneous Catheter          Drainage (PCD) in infected pancreatic necrosis (IPN).        2. To see the change in morbidity and mortality after changing the interval of surgery          after PCD   "
134293|NCT01527058|"     This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed     tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics,     biodistribution, safety and diagnostic performance of 68Ga-BNOTA-PRGD2 in healthy volunteers     and lung cancer patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg     BNOTA-PRGD2) will be intravenously injected into healthy volunteers and lung cancer patients.     Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood     pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine     aminotransferase, albumin, and creatinine, and any adverse events will be collected from the     volunteers. Adverse events will also be observed in the patients.   "
134323|NCT01526655|"     The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy     compared with abdominal hysterectomy in a fast track program gives a faster recovery     postoperatively, causes less tissue damage and less effects on the immunological system, and     is health economically cost-effective.   "
134295|NCT01527032|"     High-dose melphalan (MEL) with autologous stem cell transplant (SCT) is an effective therapy     for systemic AL amyloidosis (AL), but treatment-related mortality (TRM) has historically been     high. The investigators performed a phase II trial of risk-adapted SCT followed by adjuvant     dexamethasone (dex) and thalidomide (thal) in an attempt to reduce TRM and improve response     rates. Patients with newly diagnosed AL involving £2 organ systems were assigned to MEL 100,     140, or 200 mg/m2 with SCT, based on age, renal function and cardiac involvement. Patients     with persistent clonal plasma cell disease 3 months post-SCT received 9 months of adjuvant     thal/dex (or dex if there was a history of deep vein thrombosis or neuropathy). TRM was 4.4%.     Thirty-one patients began adjuvant therapy, with 16 (52%) completing 9 months of treatment     and 13 (42%) achieving an improvement in hematological response. By intention-to-treat,     overall hematological response rate was 71% (36% complete response) with 44% having organ     responses. With a median follow-up of 31 months, 2-year survival was 84% (95% confidence     interval: 73%, 94%). Risk-adapted SCT with adjuvant thal/ dex is feasible and results in low     TRM and high hematological and organ response rates in AL patients.   "
134296|NCT01527019|"     This study is to assess if the efficacy of cephalosporin is similar to the efficacy of     norfloxacin in the acute cystitis treatment.   "
134297|NCT01527006|"     This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel     oral suspension on seizure frequency in pediatric participants maintained on one to three     stable antiepileptic drugs   "
134298|NCT01526980|"     This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control     of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in     subjects with type 2 diabetes.   "
134299|NCT01526967|"     The purpose of this study is to estimate the incidence and severity of peristomal skin     lesions and evaluate the progression of the peristomal skin condition at 8-15 days following     application of the barrier.   "
134300|NCT01526954|"     This study is designed to evaluate the safety and efficacy of the device while reducing the     amount of drainage from surgical wounds following large flap surgical procedures, in this     case abdominoplasty, as compared to the standard of care (closure techniques). It is     hypothesized that the use of the Cohera device will facilitate reduction or closure of dead     space when applied to planar surfaces created during an abdominoplasty procedure.   "
134305|NCT01526889|"     This is a multi-center, randomized, active-controlled, open-label study. Approximately 24     patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring     systemic immunosuppressive therapy will be enrolled.      Safety, efficacy, and PK assessments will occur at scheduled visits over a 12-week period.     Low-molecular-weight non-steroidal immunosuppressive medications are allowed up to the     baseline day as long as the dose has not changed in the 3 weeks prior to baseline, except for     corticosteroid doses for which may change.      Patients responding to treatment will be offered up to 6 months of extended tretment     Assessments for safety will include laboratory safety tests, ECGs, physical exams, ocular     exams, vital signs and the monitoring of adverse events.      Study participation may vary from a minimum of 3 months to a maximum of 9 months   "
134306|NCT01526876|"     Patients with acute brain injury are at risk for complications such as increased pressure in     the brain (intracranial pressure (ICP)), decreased blood flow, bleeding, and brain swelling     (cerebral edema). Several studies have suggested that high blood pressure is associated with     a worsening outcome possibly due to an increased rate of continued bleeding or rebleeding, as     well as increased brain swelling (cerebral edema). High systemic (body) blood pressure (SBP)     may also increase the risk of ongoing bleeding. Therefore lowering the blood pressure (BP) is     critical, as continued bleeding occurs most frequently in patients with high BP.      Clevidipine Butyrate (Cleviprex) is a new medication approved by the FDA for the treatment of     acute high blood pressure (hypertension). Cleviprex is given through an intravenous line (IV)     and has the benefit of being faster acting and easier to control adjustments than other drugs     used to treat high BP. Patients who have an acute brain injury and who have severe high BP     may benefit from this faster acting medication.      For this study, eligible patients, 18 yrs of age or older, will have been admitted to the     Neurocritical care unit within 24 hours after their brain injury, who have high systemic     (body) SBP. The treating physicians will have already had multimodality brain monitoring     placed for clinical management of the patient (standard care).      The investigators will use Cleviprex to lower their SBP and record brain pressure and brain     blood flow measurements from the multimodality monitoring. Due to the severity of their brain     injury most of the patients eligible for the study will be unable to provide consent.     Informed consent will be sought from a surrogate (family member, spouse or close friend)     according to Columbia University Medical Center guidelines.      Cleviprex is fast acting and effects are seen in about 90 seconds. The medication will be     started at a low rate, and if the SBP still needs lowering, the dose increased every 90     seconds until the maximum FDA approved dose is reached. If the SBP is still high, another     medication used to treat high blood pressure will be added (Cardene or labetolol).      Once the SBP is lowered and is stable, the Cleviprex will be continued for 6 hours. As part     of standard care, patients have their blood pressure monitored continuously. After 6 hours     the treating physician will make a determination to continue clinical management with     cleviprex or another antihypertensive medication.   "
134307|NCT01526863|"     The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral     tolerance induction to egg in children allergic to egg as compared to a placebo.   "
134308|NCT01526850|"     The primary purpose of the study is to evaluate the safety and efficacy of mesenchymal stem     cells (MSC) for the treatment of patients who have developed an extensive chronic graft     versus host disease (with skin and/or liver damage) after HSCs transplantation and do not     respond to first-line therapy.      The secondary purpose of the study is to evaluate the effect of mesenchymal stem cells (MSC)     on one-year survival rate, long-term survival rate, life quality and recurrence of patients     who have developed an extensive chronic graft versus host disease (with skin and/or liver     damage) after HSCs transplantation and do not respond to hormone treatment.   "
134309|NCT01526837|"     This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into     the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first     recurrence.   "
134324|NCT01526642|"     Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory     failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed     to treat acute respiratory failure but little information is available about the benefits of     home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure     surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine     whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory     failure in COPD patients who survived an episode of acute hypoxemic respiratory failure     (AHRF) treated by Non-invasive ventilation (NIV).   "
134382|NCT01525888|"     The aim of the current study is to evaluate prospectively whether concomitant administration     of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence     the change in estimated glomerular filtration rate or GFR (eGFR) after administration of     contrast media in patients undergoing non-emergent coronary angiography.   "
134310|NCT01526824|"     In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in patients     who are candidates for neuroendovascular stenting, it is standard of care to treat these     patients with antiplatelet therapy, or blood-thinners, the most common of which is     clopidogrel (Plavix) with or without the addition of aspirin. A relatively common problem     encountered with these patients is non-responsiveness to clopidogrel therapy. A prior study     in cardiac patients showed that the addition of omega-3 polyunsaturated fatty acids (Lovaza,     or fish oil) can increase a patient's response to therapy with clopidogrel, but there have     been no studies in neuro patients. In this study, patients will be divided into one of two     groups: in the study arm, patients will receive clopidogrel +/- aspirin as well as Lovaza. In     the control arm, patients will only receive clopidogrel +/- aspirin. Assays will be done to     measure responsiveness to clopdiogrel on days 0, 12-24 hours after loading dose, day 3-5 if     still inpatient, and at a follow-up visit 20-30 days after the start of the study. The     investigators believe that this study will show an increase in platelet aggregation in     patients receiving both clopidogrel and Lovaza.   "
134311|NCT01526811|"     The purpose of this study is to assess the benefits of endovascular repair with Endurant     Stent Graft System by documenting overall mortality, complications, the rate of conversion to     open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at     5 years, in a cohort of patients representative of the population treated under real-life     conditions of use in France.   "
134312|NCT01526798|"     Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical     signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs).     This study aims to demonstrate that high cut-off hemodialysis is effective in reducing     chronic inflammation and thereby improving response to ESAs.   "
134313|NCT01526785|"     The objective of this study was to evaluate the efficacy and safety of treatment with 4000     litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.   "
134314|NCT01526772|"     Improvements in imaging technology have allowed for the development of small endoscopes     (slim scopes) half the size of a typical endoscope. These small endoscopes can be passed     transnasally into the esophagus and stomach with only local anesthesia to the nasal passage     without the need for deep sedation. They have been used in the detection of diseases of the     esophagus and stomach,3,4 but have not been used in the detection of complications in the     post bariatric population   "
134315|NCT01526759|"     Dietary fibre seems to have a relevant role in body weight management. In an acute study the     investigators found that high viscous-high gelling pectin increased feelings of satiety. The     objective of this study is to study the effects of 2 weeks of supplementation of high     gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.      The investigators do this by measuring the difference in ad libitum energy intake after 15     days of pectin or 15 days of control supplements. The investigators will further measure     differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and     composition of microbiota.   "
134316|NCT01526746|"     The purpose of this research study is to understand whether there is any difference in the     amount of tasimelteon (including its breakdown products) in the blood of individuals with     severe renal impairment compared to individuals who have normal renal function. The safety     and tolerability of tasimelteon will also be assessed throughout this study.   "
134318|NCT01526720|"     Type 2 diabetes mellitus is a complex disease whose clinical phenotype results from the     variable combination of genetic and nongenetic factors. The aim of the present study is to     investigate the network linking phenotypes and genotypes in patients with newly diagnosed     type 2 diabetes mellitus. In selected cases, in which clinical evidence hints at possible     monogenic basis of the disease, the genotype and the phenotype of relatives also will be     assessed to elucidate further the etiology of the disease.   "
134319|NCT01526707|"     Approximately 5−10% of people with asthma do not respond to to standard therapy and are     referred to as having difficult asthma. Evidence shows that this poor response is not always     related to asthma severity and non−adherence to treatment is recognized as a common     underlying problem, in 35% of these patients. Recognising non−adherence in the clinic is     problematic as there is no straightforward objective test to identify it.      Previous studies have demonstrated up-regulation of FKBP51 gene expression following     treatment with steroids, making it a potential biomarker of steroid exposure. It is therefore     also a potential biomarker of non-adherence to inhaled corticosteroid therapy. The     investigators plan to assess the feasibility of distinguishing non-adherent subjects who are     by omission steroid naïve from adherent subjects, steroid exposed subjects using FKBP51 gene     expression in sputum and throat swabs.      To do this the investigators will obtain throat swab and sputum samples from healthy     volunteers, steroid naïve asthmatics and adherent asthmatics on high dose ICS to assess if     FKBP51 gene expression is comparable in each group.      The investigators will then compare the FKBP51 gene expression response to directly observed     inhaled steroid therapy in steroid naïve, non-adherent and adherent asthmatics. This will     identify if the response in gene expression distinguishes steroid exposed (adherent) from     steroid naïve (non-adherent) patients.      Identifying non-adherence will benefit patients by enabling appropriate tailored management     for non-adherence to enhance treatment effectiveness. It will also identify patients with     therapy resistant asthma who have an unmet need and may benefit from expensive novel     therapies such as Omalizumab.   "
134320|NCT01526694|"     This is a prospective, multicenter phase II trial designed to determine efficacy and safety     of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in     patients with multiple myeloma (MM) patients after treatment with lenalidomide and bortezomib     or which are ineligible to one of these drugs.   "
134321|NCT01526681|"     This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the     uses, response rates, and safety of Avance Nerve Graft in the real life clinical setting.   "
134322|NCT01526668|"     The purpose of the study is to investigate the effect of four different follow-up strategies     on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions.     Furthermore the investigators aim to examine associations between preoperative thresholds for     pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain     after benign hysterectomy.   "
134325|NCT01526629|"     With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number     of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the     recent years. This has resulted in an increase of the number of follow-up (FU) to be     performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink     system allows to check remotely the proper functioning of self evaluating devices and give     informations of some clinical events.      The objective of this study is to define which patients with a remote follow-up need     additional onsite visit and to assess to which extent remote FU can be an alternative to     onsite visit.   "
134326|NCT01526616|"     The investigators examined whether a combined therapy with low-dose spironolactone plus     metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary     Syndrome (PCOS) patients.   "
134327|NCT01526603|"     This is a standard of care document, outlining the therapy for children with high risk     neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.   "
134328|NCT01526590|"     In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was     estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer     requires surgical removal. Surgical removal of the pancreas is associated with high morbidity     and mortality, as well as high rates of complications. One way to aid surgeons in removing     pancreatic tumors is by providing them with a good idea of where the tumor is located and     what surrounding structures are involved. This currently happens through many different     modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with     these forms of imaging (and sometimes others), surgeons will occasionally open a patient and     find that the tumor cannot be removed due to its involvement with surrounding structures.      One way to avoid potentially unnecessary procedures or to help a surgeon navigate this     delicate procedure would be to provide more detailed information about the tumor. Several of     the techniques currently used to image the body have rapidly advanced over recent years.     Typical advancements come through better resolution of the images or contrast to enhance     desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound     has seen substantial advances in resolution to enhance picture quality, but contrast has not     been used clinically to assess pancreatic masses whereas it is for cardiologists to use     contrast to look at potential defects in the heart.      The contrast that is used with ultrasound is different from that of CT scans. CT scanners use     a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some     patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with     a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound     waves differently than the surrounding tissue and thus provide contrast between normal tissue     and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used     by Cardiologists.      The CE-EUS will be used for research purposes only and will not be used for any clinical     decision making. The surgeon will be blinded to the results of the research CE-EUS. The     investigators will compare the research pre-operative contrast enhanced endoscopic     ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic     involvement seen in surgery and the pathology reports.   "
134329|NCT01526577|"     This will be a dose block-randomized, double-blind, active and placebo controlled, single and     multiple dosing, dose-escalation study to evaluate tolerability, safety and     pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital     signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and     serial blood samples and urine collections for pharmacokinetic and pharmacodynamic     evaluations will be conducted at specified time points.   "
134330|NCT01526564|"     Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse     drug reaction, and the primary manifestations are different degree of neuromotor,     sensorineural and autonomic nervous dysfunction.   "
134331|NCT01526551|"     The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus     (HPV) vaccination program to determine if the combination of increased disease and vaccine     education coupled with the removal of barriers will positively impact the HPV vaccination     uptake and completion rates among students.   "
134332|NCT01526538|"     This study will test the efficacy of d-cycloserine in enhancing response to learning-based     treatment for cocaine dependence, specifically contingency management.   "
134333|NCT01526525|"     The aim of the present study is the comparison of the efficacy of the perioperative     application of a multimodal analgesia model to the patients, combing common used analgesics     via intravenous (IV) route, such as tramadol and ketamine, with or without the     Electroacupuncture (E/A) technique application and the frequency of side effects accession.   "
134334|NCT01526512|"     The purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide and     capecitabine in pretreated metastatic breast cancer.   "
134335|NCT01526499|"     The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition     to docetaxel in first line therapy in metastatic breast cancer.   "
134336|NCT01526486|"     Patients with melanoma, some other rare skin cancers, and some cancers of the penis and     scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called     the groin. Medically, this area is called the inguinal area. At present, for melanomas and     skin cancers this type of spread is usually found with a special test called a sentinel     lymph node biopsy. This procedure can find spread of even a few cells in a single lymph     node—allowing the treating doctor to find the spread very early.      Treatment for patients with skin cancer in the lymph nodes in this area is to remove all of     the lymph nodes in this area. In patients with cancers of the penis and scrotum who do hot     have any evidence of cancer having spread either by physical examination or by radiology     tests, the lymph nodes in this area are removed to check and see if there is cancer in them.     This is called staging.      At present, the standard way to remove all of the lymph nodes in the groin is by a large     incision, approximately 8-10 inches in length. For patients who have this operation, there is     a very high incidence of infection after surgery: as many as 50% as patients can have a     problem after surgery. These infections range from a low grade skin infection needing oral     antibiotics to deep infections requiring the wound to be opened and occasionally needing     readmission to the hospital and antibiotics given via the vein.      With the advent of new technology and new equipment, the ability to perform this procedure     through small incisions away from the groin and further down the leg has become possible.     This procedure has never been performed routinely nor compared side by side to the standard     open approach. The investigators propose to perform this protocol in two phases.      The investigators have performed procedures in 20 groins to this point and have confirmed the     number of lymph nodes and visually verified that the procedure is identical to the open     procedure. The investigators performed these procedures in order to insure that the     investigators were offering an equivalent option regardless of which procedure the patient is     randomized to.      The study will involve the randomization of patients undergoing the procedure. The     investigators will randomize the next 110 patients in a 2:1 fashion (two people will get the     videoscopic procedure for every one who gets the open procedure) until 73 patients are     included in the video arm and 37 in the open arm. Outcomes including recurrence rate,     duration of drain requirements, and incidence of lymphedema will be followed. Patients will     be followed using standard of care processes, including regular office visits, physical     exams, and radiographic imaging, when indicated. Patients will be followed for 5 years.   "
134349|NCT01526317|"     This clinical trial is designed to compare the pharmacokinetic characteristics of combination     and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also     investigate drug interaction between separate and combination administration.      Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day     administration, 10 days washout after 5th day of administration.      All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each     period.   "
134399|NCT01525667|"     Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of     injured gluteal musculature after Total Hip Arthroplasty (THA).   "
134337|NCT01526473|"     HER2 is a protein that is over expressed in 20-30% of breast cancers. It is also found     associated with lung, gastric, ovarian, and pancreatic cancers. Although there are existing     therapies that can target HER2, most patients will eventually experience progression of their     disease even though their cancer continues to express HER2. Therefore, new approaches are     needed for treating tumors that express HER2.      This clinical trial will use an investigational cancer vaccine called HER2 VRP or AVX901. The     vaccine is based on a virus called Venezuelan equine encephalitis but it has been changed so     it cannot cause active infection. Instead, the virus has been changed so it tells the immune     system to attack cancer cells which make HER2.      The objectives of the study are to evaluate the safety of immunization with HER2 VRP in     patients with advanced or metastatic malignancies that express HER2, and to test whether     immunization will causes a strong immune system attack against the cancer.   "
134338|NCT01526460|"     The purpose of this study is to evaluate the effect of a loading dose of two different     statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which     is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and     clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for     coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.   "
134339|NCT01526447|"     The purpose of this randomized controlled trial is to determinate the efficacy and safety of     Craniosacral Therapy in the treatment of chronic unspecific neck pain.   "
134340|NCT01526434|"     The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical     function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in     Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis     Factor alpha (TNFα) Certolizumab Pegol (CZP).   "
134341|NCT01526421|"     Highly active antiretroviral therapy (HAART), the current standard of care for treatment of     HIV infection, is highly effective when taken appropriately. Before starting this treatment,     a person must be aware of their HIV status and present to a clinic for medical care. They     then undergo screening procedures (medical assessment and laboratory tests) to determine     whether they are eligible to receive HAART, i.e. whether HIV treatment is necessary and safe     for them.      In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV     infection among users of illicit drugs. However, HIV-infected drug users often do not present     to the medical system and complete the process necessary to start HAART. Given the known     benefits of HAART, new strategies are required to increase rates of HAART initiation in this     group. Contingency management (CM) is a strategy to affect behaviour by providing a reward     (e.g. money) to reinforce the desired behaviour. CM has been used with success in other areas     of medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has     not been established as a means to improve HAART uptake.      The proposed research primarily seeks to assess the effectiveness of monetary-based CM in     engaging HIV-infected drug users in HAART programs. Drug users identified through outreach     will be randomized in a 1:1 ratio to one of two arms; participants in one arm will be offered     a monetary-based reinforcer to participate (n=150) and participants in the second arm will be     offered no reinforcer (n=150). Participation involves reporting to the study site for formal     study of eligibility screening, consisting of clinical evaluation, medical history and     laboratory testing required to determine eligibility to receive HAART. Participants     randomized to the reinforcer arm will receive gift cards at the completion of screening     procedures.      Our hypothesis is that drug users offered a monetary-based reinforcer will be significantly     more likely to complete HAART eligibility screening than those not offered a reinforcer.   "
134342|NCT01526408|"     The specific aim of this study is to determine the efficacy of treatment with famciclovir in     unilateral Meniere's Disease patients, specifically whether hearing can be improved. The     investigators will determine the percentage of unilateral Meniere's Disease patients     experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir     as compared to the placebo arm.   "
134343|NCT01526395|"     In developing countries, electroconvulsive therapy (ECT) is typically delivered without the     use of an anesthetic prior to the treatment, known as unmodified ECT. This interventional     study aims to decrease the practice of unmodified ECT at Chhatrapati Shahuji Maharaj Medical     University, U.P. & G.M. & Associated Hospitals (C.S.M) by administering a low dose anesthetic     (propofol) prior to ECT delivery. In so doing, the investigators hope to facilitate the     transition from unmodified to modified ECT without incurring excessive costs to the center.     It is hypothesized that ECT patients will opt for modified treatment, that adverse effects     will be minimal, and that costs will not rise prohibitively.   "
134344|NCT01526382|"     PiCCO has been widely used in critical care settings for several decades. Together with     pulmonary artery catheter, it is regarded as the important tool for guiding fluid management     in patients with shock or acute respiratory distress syndrome. However, its effects on     patients' outcome remain untested. The investigators study is a pilot study that is designed     to test whether the use of PiCCO will improve patients' outcome, as compared to those without     PiCCO monitoring.   "
134345|NCT01526369|"     The proposed phase III randomised trial will compare the efficacy of trastuzumab and     paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2     positive metastatic breast cancer. The investigators will also examine potential predictive     biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum     samples.   "
134346|NCT01526356|"     The study is a multi-center prospective, randomized, double-blind, placebo-controlled     evaluation of the safety and efficacy of a topically applied formulation of rapamycin to     cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will     apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to     their angiofibromas for six months.      The primary goal of this study is to evaluate the efficacy of the topical medication for     reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study     is to confirm the safety of the topical medication.   "
134347|NCT01526343|"     While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years,     virtually all of the historical series reported only the recurrence of symptomatic AF and     have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of     traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the     Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative     arrhythmia burden following surgical treatment for AF in patients undergoing either lone or     concomitant heart surgery.   "
134348|NCT01526330|"     The objective of this study is to assess the safety and tolerability of YH14618 during 24     weeks of follow-up period after single administration in patients with degenerative disc     disease.   "
134402|NCT01525628|"     To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their     combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment     naive or prior treatment relapse patients with chronic hepatitis C infection.   "
134350|NCT01526304|"     Kidney stones are very common in industrialized countries and the lifetime risk is about 10     to 15% in this population. Kidney stones are composed of inorganic and organic components.     Calcium containing stones are the most common stone type accounting for more than 80% of     kidney stones. Many factors predispose or contribute to the development of kidney stones,     including genetic variants or mutations, diet, environmental factors, and behavior. To date,     little is known on fibroblast growth factor (FGF23) levels in patients with calcium     nephrolithiasis. FGF23 is crucial for phosphate homeostasis including physiological and     pathophysiological conditions such as X-linked hypophosphatemic rickets and it seems that     FGF23 is probably the most important regulator of serum phosphate and calcitriol     (1,25(OH)2D3) levels in addition to parathyroid hormone (PTH) produced by the parathyroid     gland. Novel factors such as Klotho and Sclerostin, which are involved in the     bone-kidney-parathyroid endocrine axis, have been identified recently. Klotho is a putative     aging suppressor gene and its deficiency results in osteopenia, hyperphosphaturia, and     calcification. Klotho is mainly expressed in the kidney but also in the parathyroid gland and     acts as a FGF23 specific co-receptor mediating FGF23 participation in the     bone-kidney-parathyroid endocrine axis as described above. Sclerostin is a protein secreted     by osteocytes that inhibits bone formation by osteoblasts. However, the potential role of     FGF23, Klotho, and Sclerostin in nephrolithiasis is still poorly under-stood or even     unexplored. The aim of this study is to test if levels of FGF23, Klotho, and Sclerostin are     differentially regulated in kidney stone formers.   "
134351|NCT01526291|"     This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related     quality of life (QOL)in up to 550 active duty subjects prior to and six months following     state-of-the-art laser in situ keratomileusis (LASIK).   "
134352|NCT01526278|"     This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy     postmenopausal women   "
134353|NCT01526265|"     Using the NIH-funded Way to Health platform, the investigators will conduct this smoking     cessation randomized controlled trial (RCT) among CVS employees. The investigators will be     able to determine the comparative and absolute efficacy and effectiveness of 4 different     incentive structures that are each grounded in behavioral economic principles. Additionally,     the investigators will measure rates of and reasons for acceptance of each incentive     structure, and examine participant characteristics that modify the efficacy and acceptance of     different incentive structures.   "
134375|NCT01525979|"     This proposed project aims to        -  compare the effects of dose-matched unilateral vs bilateral vs unilateral combined with          bilateral upper limb rehabilitation based on task-related practice        -  compare the effects of unilateral vs bilateral training based on robot-assisted devices        -  study the predictors of treatment outcomes and clinimetric properties of the          biomechanical measures   "
134354|NCT01526252|"     The SCAR study uses a software program entitled QLAB, a proprietory program, developed by     Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle     tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study is     minimal. Accumulation of data relevant for a population of subjects will provide a set of     normal values for interpretation of 2DSTE and minimize any influences from differences in     data produced from different companies. This data may also assist other researchers     investigate other cardiac diseases and abnormalities.   "
134355|NCT01526239|"     Colorectal cancer is the third most common cancer diagnosed and third leading cause of     cancer-related deaths in the United States for both men and women. The American Cancer     Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of     rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this     devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been     dropping as a result of screening and early detection of cancer. In 2007, ACS reported that     early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could     be prevented each year if eligible patients received screening when necessary. However,     despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible     US patients are currently being screened.      Specific Aims      The central hypothesis of this proposal is that patient-initiated prompting of primary care     physicians of the patient's interest in screening will increase referrals for CRC screening.     The following three areas will be investigated during this research:        1. To determine whether a communication tool provided to patients will initiate a          conversation with their primary care physicians about CRC screening, especially via          colonoscopy.        2. To determine whether this tool will impact referral patterns for screening, especially,          although not primarily, among poor and underserved populations.        3. To determine whether differences exist in regard to patient-physician communication          patterns about screening among residents and faculties in the fields of internal          medicine and family practice clinics.      At the close of the investigators study, the investigators wish to organize quantifiable data     demonstrating how patient-initiated prompting of primary care physicians for CRC screening     increases early detection and decreases potential mortality from colorectal cancer. This data     will inform a second, larger study to pursue the questions surrounding patient-initiated     prompting in   "
134356|NCT01526226|"     Preterm children are at increased risk for developing lung disease due to immature lungs.     Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous     positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal     cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased     pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short     binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With     HFNC oxygen/air is administered via two small, thin cannulas located just inside the     nostrils, but the nostrils are not blocked.      The aim of this study is to compare patient comfort in premature infants treated with nCPAP     and HFNC. The investigators hypothesis is that HFNC increases patient comfort.      The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion     should be born before 34 weeks of gestation and have moderate respiratory distress, thus be     in need of nCPAP. During the study period (48 hours) the investigators will consider how     the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort     assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress     hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The     child's breathing pattern will be carefully monitored. The study involves no extra painful     investigations.      The investigators plan to recruit 20 patients.   "
134380|NCT01525914|"     Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with     dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men     who harbor occult high grade prostate cancer.      The study will determine the prevalence of a secondary rise in PSA > 0.5 ng/ml and the PSA     doubling time in subjects on surveillance being treated with dutasteride.   "
134404|NCT01525602|"     The goal of this clinical study is to learn how PLX3397 and paclitaxel work together to     affect the growth of cancer cells in advanced solid tumors.   "
134357|NCT01526213|"     Purpose: Grapefruit juice is one of the most extensively studied dietary/natural substances     shown to interact with a variety of medications. However, unanswered questions remain     regarding the causative ingredients and mechanisms underlying such drug-grapefruit juice     interactions. Compounds in grapefruit juice called furanocoumarins have been established as     major causative ingredients, which act by inhibiting the elimination (metabolism) of drugs,     leading to increased circulating drug concentrations. Increased drug concentrations can in     turn lead to increased drug potency or even toxicity. Grapefruit juice also has been shown,     paradoxically, to decrease circulating concentrations of some drugs, including the     non-sedating antihistamine agent, fexofenadine (Allegra), which undergoes negligible     metabolism. Whether or not furanocoumarins mediate the decrease in fexofenadine     concentrations is unknown. The purpose of the proposed study is to compare the effects of a     furanocoumarin-free grapefruit juice with grapefruit juice on circulating concentrations of     fexofenadine.   "
134358|NCT01526200|"     Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver     metastases (CLM) has become a part of clinical practice. However, if it should be selectively     or routinely applied remains unclear. This study is carried out to clarify which are the     criteria for a selective use of CE-IOUS if any.   "
134359|NCT01526187|"     The purpose of this study is to Measure the fecal carriage of multidrug-resistant bacteria     after a travel in the tropics.   "
134360|NCT01526174|"     The investigators plan to conduct an open-label intratympanic injection proof-of-concept     trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients     with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm     approach. First, the investigators propose to dose 3 individual subjects with a single     intratympanic injection of golimumab and follow each for 30 days, closely examining them for     adverse events. If there are no serious adverse events, with FDA approval, the investigators     propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.   "
134361|NCT01526161|"     Asthma affects 1 in 8 children in the UK. Up to half of these are treated with preventative     medicine in the form of low-dose steroids using an inhaler. The National Asthma Treatment     Guidelines recommend when this treatment is not working other treatments are started. Studies     to support this have taken place in adults but not with children. If patients are instructed     how to use inhalers and are given information about asthma, they can control their disease     much better. The first part of this study, lasting 4 weeks, will make sure the children and     their families understand how to use their inhaler. All children will be given the same     steroid inhaler to use and after 4 weeks those still with symptoms will enter the study     proper which lasts for 48 weeks. During this part of the study the children will be given one     of three treatments. These are:- a steroid inhaler + a dummy tablet, an inhaler containing a     steroid and a long-acting reliever + a dummy tablet or a steroid inhaler + an active tablet.     In this way the patient, the family and the researchers will not know which of the three     treatments the child is taking until the code is broken at the end of the study.      What matters to children is how they feel, are they able to run around and play with friends     and are they well enough to go to school. The investigators will assess which of the above     treatments best allow these to happen by asking the parents and children to fill in     questionnaires on 4 occasions during the study. The investigators will also see which     treatment best prevents the need for short courses of steroids tablets during the study.     These are commonly given when asthma symptoms worsen.      Most children will be started in the study through their general practitioner clinic. It will     take one year to enroll all 900 children. Once enrolled the children will be followed-up in     hospital centres. Much of the funding will be required to recruit and follow-up the children,     train everyone to the same standard and develop and administer the questionnaires and health     economic assessments. Asthma care is an expensive. The investigators will look at the costs     and assess which treatment offers most benefit. The team has experience and ability in this     field and will ensure the results are well publicised. Any child can withdraw from the study     at any time.   "
134362|NCT01526148|"     This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness     trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who     currently require a medication change for their illness. Stratified randomization will reduce     bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment     goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is     the difference between lithium and quetiapine in the time to 'all cause' medication     discontinuation.   "
134363|NCT01526135|"     This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with     gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in     patients with resected pancreatic adenocarcinoma.   "
134364|NCT01526122|"     The purpose of this study is to compare characteristics and safety after oral administration     of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2     capsules coadministration in healthy male volunteers.   "
134365|NCT01526109|"     Quality of Life (Qol) is a complex concept which relates to the perception of subjective     satisfaction, especially in elderly population. It also relates to the self-perception of     psychological status, independence level, to the social relationships, and to the environment     where the elderly person lives. Consequently, there are a number of factors which may change     the perception of QoL, namely the occurrence of diseases, physical impairment or incapacity,     and the rupture of social relationship, as well as the aging process itself. Physical     exercise is associated to improvement of mental and physical health. However, few studies     investigated the effect of strength training and whole- body vibration training on elderly     subjects. Following this line of reasoning, the purpose of the present study is to assess the     effect of physical exercise on cognition and functional abilities in elderly subjects.     Design: Randomized controlled trial, double-blinded, with 12-week follow-up. Setting: Gama     Filho University. Participants: Healthy Elderly. Interventions: The patients will be randomly     assigned to a strength training group (STG), whole-body vibration training group (WBVG) and a     control group (CG). Main outcome measures: Cognitive function will be assessed using Mini     Metal State Examination (MMSE), Trail A and B, Digit Span, Stroop Test, Rey auditory-verbal     learning test and Clock Test, and functional capacity will be evaluated using Senior Fitness     Test, American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional     fitness test, and Short Form 36(SF-36) health survey.   "
134366|NCT01526096|"     The purpose of this study is to test whether regulatory T-cell reduction is possible and safe     in myeloma subjects undergoing autologous stem cell transplantation (ASCT).   "
134367|NCT01526083|"     The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid)     on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy     male volunteers.   "
134400|NCT01525654|"     The goal of PARASS is to develop a network of increased social support for Rheumatoid     Arthritis (RA) patients that will improve patient outcomes and further promote understanding     of RA among physicians and patients in the clinic community. This will be accomplished with     the development and implementation of Buddy pairing and one -on- one informational support to     be called Patient-to-Patient Connection.   "
134368|NCT01526070|"     Over the last several years, the standard of care for wet macular degeneration has become     treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as     frequently as every 4 weeks. In contrast, clinical trials of a soluble VEGF receptor,     Aflibercept/VEGF Trap-Eye (Eylea, Regeneron Pharmaceuticals) have demonstrated maintained     anatomic and visual improvement with many fewer injections (typically monthly injections for     3 months, followed by every-other-month injections, and as few as 5 injections a year). The     purpose of this study is to determine whether patients who have switched from ranibizumab to     VEGF Trap-Eye have comparable results.   "
134369|NCT01526057|"     In this study, patients with moderate to severe rheumatoid arthritis who are being treated     with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan     (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs     will be assessed by sampling the levels of drug in the blood, blood cell counts, and by     comparing these levels among the different treatments. Safety, tolerability and immunologic     response also will be evaluated throughout.   "
134370|NCT01526044|"     The purpose of this study is to evaluate the accuracy and reliability of the continuous     glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill     patients by comparing subcutaneous measuring with the current standard of arterial measuring     by a point of care glucometer.   "
134371|NCT01526031|"     The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture     (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose     effective.   "
134372|NCT01526018|"     The purpose of this study is to pilot test whether a novel infant feeding bottle changes how     much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided     in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided     with the novel feeding bottle and caregivers will be asked to acclimate their infant to this     bottle during the next several weeks. Once acclimated, infants will undergo two weighed,     timed, and videotaped test meals on two separate days; one with the novel bottle and one with     their standard bottle, in random order. It is hypothesized that when the novel bottle is     used, infants bottle will consume smaller meals and will have a longer meal duration, as     compared to when a standard bottle is used.   "
134373|NCT01526005|"     Even though the health risks and societal costs of cigarette smoking are well-known, roughly     19.8% of American adults continue to smoke. While most smokers endorse a desire to quit, very     few (< 5%) will actually quit in a given year without treatment, and only about 20-25%     achieve abstinence after 6 months or more of effective treatment. Therefore, there continues     to be a vital need to improve outcomes for cigarette smokers seeking treatment. Current     first-line medications for Tobacco Dependence include nicotine replacement therapies (such as     the patch, gum, lozenge, nasal spray, and inhaler), varenicline HCl (Chantix), and bupropion     HCl (Zyban), with the current standard of care in most treatment settings being to choose     specific medications based primarily on availability, ease of use, and patient preference.     The goal of the proposed research is to improve the delivery of smoking cessation treatment     by determining if pre-treatment nicotine receptor density in cigarette smokers is associated     with smoking cessation outcome with the standard nicotine patch taper. The study's main     hypothesis is that cigarette smokers with less pre-treatment upregulation of nicotine     receptors will have a greater likelihood of quitting smoking from a standard course of     nicotine patch treatment than smokers with more up-regulation of these receptors. Positron     emission tomography (PET) will be used to test this hypothesis.   "
134376|NCT01525966|"     This phase II trial studies how well giving carboplatin and paclitaxel albumin-stabilized     nanoparticle formulation together before surgery works in treating patients with locally     advanced or inflammatory triple negative breast cancer. Drugs used in chemotherapy, such as     carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount     of normal tissue that needs to be removed.   "
134377|NCT01525953|"     The aim of this study is to identify prognostic factors for outcome in patients being     complete clinical responders with chemoradiation or radiation for esophageal cancer   "
134378|NCT01525940|"     Colorectal cancer (CRC) is the second most common cause of cancer-related death in the     Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary     CRC screening tool in many countries. As a preventative procedure, its main purpose is to     enable the early diagnosis of CRC at a curable stage and to identify and remove pre-malignant     adenomas. Cecal intubation is associated with an increased detection rate of advanced     neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. Complete colonic     evaluation is therefore a well-recognized measure of colonoscopy quality control. Cecal     intubation rates of ≥ 90% of all colonoscopies in routine clinical practice and ≥ 95% in     screening colonoscopies are recommended. Unfortunately, the cecal intubation rate in daily     clinical practice is often lower than the target of ≥ 90%, with reported percentages varying     from 76.9% to 98.4%. This means that after an incomplete colonoscopy, malignant and     pre-malignant lesions may be missed if further investigation is not pursued. Several     explanatory factors for incomplete colonoscopy have been described. After an incomplete     conventional colonoscopy, patients are required to undergo another test to complete the     visualization of the colon. Options for incomplete examinations because of anatomic reasons     include both radiologic and endoscopic means.      CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not     require sedation and is well accepted by the patient.      The PillCam Colon Capsule Endoscopy (Given® Diagnostic System)offers an alternative approach     for endoscopic visualization of the colon in patients with an incomplete conventional     colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include the elimination     of the need for sedation, the minimally invasive, painless nature of the exam, no need of     X-rays and the ability to pursue normal daily activities immediately following the procedure.     This is a study that is designed to evaluate the performance of the PCCE in the evaluation of     patients with an incomplete colonoscopy, compared to the CT-colonography. PCCE and     CT-colonography procedures will be compared in regards to completeness of the procedure and     detection of lesions in the colon that would have been missed by the incomplete conventional     colonoscopy.   "
134379|NCT01525927|"     This study looks at the use of three cycles of chemotherapy given prior to radiation therapy     in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma     Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV     have a better prognosis than those who do not have such evidence of exposure to HPV. The main     hypothesis of this study is that using three cycles of chemotherapy prior to embarking on     radiation therapy will allow the use of reduced doses of radiation therapy and, therefore,     less radiation induced side-effects. The primary objective is to determine the activity of     this pre-radiation chemotherapy strategy along with reduced dose levels of radiation with or     without chemotherapy during the radiation phase. The effectiveness of the strategy will be     assessed at three months following the completion of the radiation therapy phase and also at     two years following completion of the radiation therapy.   "
134383|NCT01525875|"     The purpose of this study is to evaluate the effectiveness of magnesium oxide supplements on     the reversal of calcium deposits in the skin, and the yellow bumps and folds of skin in     subjects with pseudoxanthoma elasticum (PXE). Magnesium oxide is a dietary supplement that     has been shown in some research to reduce these calcium deposits. This study consists of two     parts. The first part is a year-long, double-blind, placebo-controlled study. Part two is an     open-label, year-long study. In Part 1, qualified subjects will be randomized to receive     either magnesium oxide supplements or placebo, in a 1:1 ratio for the first 12 months. The     starting dose will be 1000 mg daily, and depending on tolerability, doses may be decreased.     Baseline evaluations will be comprised of: blood tests; clinical evaluations; skin biopsy;     eye examination; bone density test; and photography of skin lesions. Subjects will be     evaluated at week 2, week 6, month 3, and then every 3 months during the first year. Upon     completion of the first year, barring any safety concerns, all subjects will be administered     magnesium oxide supplements for up to one additional year. Subjects will undergo the same     evaluations/ procedures every 3 months. We hypothesize that the magnesium oxide will cause a     reduction in calcifications in the subject's soft tissue/skin. Funding Source - FDA OOPD.   "
134384|NCT01525862|"     This is a study looking at transnasal sinus balloon dilation without tissue removal treating     the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic     improvement post-procedure.   "
134385|NCT01525849|"     The objective of this study is to show that long-term symptom improvement after sinus balloon     dilation is not worse than symptom improvement after functional endoscopic sinus surgery     (FESS) and that fewer postoperative debridements are required after balloon dilation than     after FESS.   "
134386|NCT01525836|"     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known     hospitals in China. In order to report the efficacy and safety of Recombinant Human     thrombopoietin combining with Rituximab for the treatment of adults with refractory immune     thrombocytopenia (ITP), compared to conventional Rituximab therapy.   "
134387|NCT01525823|"     The purpose of this study is to assess the effects of Metformin administered over two weeks     on the peak plasma glucose concentrations following administration of BMS-754807.   "
134390|NCT01525784|"     The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age     groups, especially among infants and toddlers.However, only 30% of diabetic children manage     to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are     treated by intensive insulin therapy.Recently, devices for real-time continuous glucose     monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These     devices enable the patients to see the interstitial glucose levels continuously, the trends     of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .      The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years     in 2011, indicated for those with recurrent hypoglycemic episodes. So, the aim of the     investigators study is to examine prospectively the short and long term effect of the RT-CGMS     routine usage, in daily routine life of the diabetic child.   "
134391|NCT01525771|"     A maximum of 8 cycles of chemotherapy will be administered. Depending on patients'     tolerability, 8 cycles of chemotherapy will be given to the patients.   "
134392|NCT01525758|"     The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with     knee osteoarthritis by orally administration and to determine optimal dose.   "
134393|NCT01525745|"     The purpose of this study is to determine how effective SBRT is compared to traditional     radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is     delivered at a higher dose for a shorter period of time when compared to standard radiation     therapy and the aim is to see if there will be an improvement both in pain control and your     cancer It is not known whether SBRT is better or worse than current standard therapy. If you     are selected to receive the experimental treatment in this research study, SBRT uses highly     focused x-rays that deliver a single high dose to a specific area of the spine compared to     conventional standard radiation over a period of 10 days which has been the standard proven     treatment to help your condition. The investigators will also determine which treatment     provides the most rapid pain relief with the least side effects. It is possible that SBRT may     not be better or could be more toxic. The investigators will conduct quality of life     assessments and pain scale index to assess how you are feeling once you have had the     intervention.   "
134394|NCT01525732|"     Spastic esophageal motility disorders induced significant symptoms including dysphagia,     retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel     approach to perform myotomy through the esophagus with long submucosal tunnel. This study     aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from     animal study to clinical practice in human.   "
134395|NCT01525719|"     The purpose of this study is to determine whether everolimus is effective in the treatment of     patients with advance cholangiocarcinoma.   "
134396|NCT01525706|"     Pancreatic cysts are becoming diagnosed more frequently due to the increased use and     sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested     treatment is surgery for removal. However, surgery involves significant risks and emerging     opinion suggests that not all cysts need to be surgically removed. An alternative therapy     would be ideal, in particular for those where surgical risk outweighs the benefits of     resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to     surgical resection.      Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for     treatment in those with per-cancerous, mucinous pancreatic cysts.   "
134397|NCT01525693|"     This is a study to gain better understanding on how those patients who are newly diagnosed     with type 2 diabetes are treated and monitored. The study will record information such as     type of therapy, therapeutic outcomes, and patients' satisfaction.   "
134398|NCT01525680|"     This study seeks to examine the efficacy of hydrocortisone administration in the augmentation     of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested     treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD).     The augmentation builds on both the translation of neuroscience findings demonstrating the     effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other     investigators demonstrating beneficial effects of GCs in reducing traumatic memories in     trauma-exposed persons.   "
134405|NCT01525589|"     A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of     PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts     response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety     profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD     (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx)     expression profile in tumor samples.   "
134406|NCT01525576|"     In this trial, we test if adding an Internet-based booster program to regular Internet-based     cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive     disorder (OCD).   "
134407|NCT01525563|"     In India Duphaston is approved and widely used for the treatment of progesterone deficiencies     such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular     cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual     abortion, infertility due to luteal insufficiency, as well as part of hormone replacement     therapy. One Indian study reported normalization of the cycle in 91.6% of women with     menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from 11th to     the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone therapy in     this study was noted to be 28.8 days, in contrast to 17.9 days (in the polymenorrhea group)     and 50.6 days (in the oligomenorrhea group) before therapy. Furthermore, dydrogesterone also     decreased the amount and duration of menstrual bleeding in this study.      However, there are limited data regarding Duphaston's role in achieving cycle regularization     from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston     therapy persists after cessation of treatment and whether the persistent effect, if any, is     related to the duration of Duphaston therapy.      Hence, in this observational study, given that (based on previous clinical studies as     mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is to     tease out the possible implications of such treatment in terms of treatment length and     response pattern.   "
134408|NCT01525550|"     The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with     unresectable pancreatic neuroendocrine tumors.   "
134409|NCT01525537|"     The aim of the present study was to compare SPI guided analgesia with standard clinical     practise during general anesthesia using a balanced setting of sevoflurane and sufentanil     anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular     stability, less use of analgetics and shorter recovery from anesthesia.   "
134410|NCT01525524|"     Stroke is one of the main public health problems in America Latina. It can be associated with     several neuropsychiatric complications, which include a broad spectrum of emotional distress     and cognitive, results in important clinical implications for the prognosis of these     patients. Depression is a common complication, affecting around 5-72% of patients and is     associated with various cognitive deficits and also with increased mortality - up to 50% more     deaths compared to non-depressed patients. Treatment of depression after stroke is important     not only to improve depressive symptoms but can also be beneficial for cognitive deficits,     activities of daily living. and leads to increased survival for these patients. There are     different treatments for depression after stroke, all showing inconclusive results, even     though antidepressants have been effective in some groups of patients, tolerability and     treatment adherence were not very good-so it is necessary that new therapeutic modalities are     presented with good tolerability. In this sense, transcranial direct current stimulation     (tDCS) is an interesting technique that can provide interesting results, which proved to be     effective for depression in some studies. This study proposes to investigate the effect of     tDCS for the treatment of major depressive disorder after stroke. The proposed design is a     clinical trial, randomized, double-blind, placebo-controlled study in a subsample of     participants in the prospective cohort of stroke: Study of Morbidity and Mortality of stroke.     They will be allocated to one of the groups: sham or active tDCS group. Participants will     receive ten consecutive days of active or sham stimulation and return at the end of two weeks     to evaluate the improvement in depression, cognition and functionality. As objectives, the     investigators expect to see a clinical improvement of depression through scales like     Hamilton, Beck and MADRS(Montgomery-Asberg Depression Rating Scale), and expect improvement     on cognitive tests as MoCA (Montreal Cognitive Assessment), MMSE (mini mental scale exam),     FAB (frontal assessment battery) and trail test. Another goal is to see improvement in     markers related to depression as BDNF, cortisol, interleukins and heart rate variability.     With all this, the investigators hope to offer a new treatment, and effective with few side     effects to treat depression after stroke.   "
134411|NCT01525511|"     The observed changes of P. falciparum sensitivity to artemisinin leads to the intensification     of early detection as well as treatment monitoring in malaria infection. It is widely     accepted that the development of resistance can be delayed by the use of combination therapy,     especially artemisinin-based combination therapies (ACTs). The resistance problem is     considered extremely serious and as the consequence WHO has recommended that all monotherapy     for malaria should be stopped Current WHO guideline recommends the drug combination regimens     using ACT with effective partner medicines to decrease the risk of development or spreading     of artemisinin resistance.      Dihydroartemisinin-piperaquine (DHA-PQP); the fixed-dose combination of Dihydroartemisinin     (DHA) and Piperaquine phosphate (PQP) is now one of the recommended drugs by WHO as the oral     treatment for uncomplicated P. falciparum. DHA-PQP composes of both blood schizonticidal     drugs, with different mechanism of action and different half-life to improve the therapeutic     efficacy and to prevent the development of drug resistance to the individual drug. Moreover,     it is beneficial for the mutual protection against resistance and long lasting protection     against new infection, due to long half-life of PQP.      Primaquine is an effective gametocytocidal for P. falciparum transmission prevention and as     tissue killing for the radical cure in Plasmodium vivax and Plasmodium ovale infection. It     will be given only in the presence of other antimalarials, so it is necessary that the data     of the potential drugs interaction of primaquine and DHA-PQP should be characterized. It is     inevitable that in the near future, Dihydroartemisinin-piperaquine (DHA-PQP) and primaquine     combination treatment becomes necessary. These drugs are metabolized by cytochrome P450     enzyme which potentially causes pharmacokinetic alteration, resulting in clinically     significant drug-drug interactions that can cause unanticipated adverse reactions or     therapeutic failures because of the suboptimal exposure of the parasite.      This study is planned to evaluate potential pharmacokinetic interaction of orally     administered primaquine (PQ) and dihydroartemisinin-piperaquine (DHA-PQP) in healthy adult     subjects. The results of these interaction studies are important in order to provide clinical     guidance for the optimum combination of primaquine and DHA-PQP treatment regimens in malaria     infections.   "
134412|NCT01525498|"     The objective of this study is to prospectively evaluate the effects of early versus delayed     removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim     is to determine the optimal time of removal of an indwelling transurethral catheter     postoperatively in an effort to reduce the risk of postoperative urinary retention and     urinary tract infection associated with catheter use. The investigators hypotheses are as     follows:      Hypothesis 1: Longer duration of postoperative catheter use will result in decreased     postoperative urinary retention.      Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence     of urinary tract infection.   "
134413|NCT01525485|"     This prospective study compares quality of life measures of patients with refractory     overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation     (Group A) and sacral nerve stimulation (Group B).      The specific aims are:      1. To characterize patient symptom bother score, quality of life, and body image scores in     patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation.      - Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of     life, patient symptoms, and body image questionnaires.   "
134434|NCT01525199|"     The purpose of this trial is to compare the evolution of patients receiving first line     treatment for locally advanced or metastatic lung cancer, taking into account if they were     requested or not the EGFR mutation test as part of the diagnosis and treatment strategy.     There is no assignment to any particular therapeutic strategy.   "
134517|NCT01524107|"     The medical literature does not provide sufficient information or recommendation regarding     specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to     compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections     for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to     develop a standard treatment protocol. The Medical Record review will include many parameters     including complications, type of antibiotic usage etc.   "
134414|NCT01525472|"     Numerous epidemiological studies clearly showed the relationship between the excessive growth     of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and     other cardiovascular risk factors. However, the mechanisms contributing to the deleterious     role of visceral adipose tissue remain to be elucidated. Several observations suggest that     adipose tissue depots exhibit distinct metabolic and secretory capacities according to their     locations. We have recently shown that visceral fat depots display higher immuno-inflammatory     cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of     visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and     several markers related to aging. Finally, we have shown that visceral adipocyte-derived     secretions promote the endothelial cell senescence in an extent higher than subcutaneous     adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon     related to the location and therefore the microenvironment of adipose tissue and 2) might be     responsible for an abnormal activation of proinflammatory response, favouring the development     of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis,     based on these observations, is that the visceral adipose tissue provides a microenvironment     that promotes accelerated aging. This senescence may be responsible for the establishment of     an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation     capacity of progenitor cells leading to the development of obesity associated diseases.      The proposed project is a descriptive cross-sectional pathophysiological study .The aims are     1) to better define the process of senescence in human adipose tissue, 2) to precise the     mechanisms and 3) to analyse the cellular and functional consequences of aging on     inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for     bariatric surgery will be studied. The collection of clinical and laboratory data and the     collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose     tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis     Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in     vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells,     progenitor cells and immuno-inflammatory cells).      This project will permit to better understand the pathogenicity associated with the excessive     growth of visceral adipose tissue and may reveal new therapeutic targets to limit     obesity-associated pathologies.   "
134415|NCT01525459|"     Study on glioma patients treated with brain surgery is focusing on the analysis of their     transcriptome expression profile measured in two immune cell populations, CD4+ T cells and     CD56+ NK cells. The results of analysis will be compared to the reference data of healthy     population. Furthermore, the metabolomic and immunological status will also be monitored and     compared to healthy group reference data, before and after the surgery*. With comparative     crossomics analysis the investigators intend to possibly identify new diagnostic and     prognostic biological markers for the relapse of the disease. The results are expected to     convey a deeper insight into pathophysiology of the glioma as well as into the mechanisms of     the current surgical therapy.      * The healthy reference data have been published in collaborative efforts of BTC, UMC and NIB     (Gruden et al. 2012).   "
134416|NCT01525446|"     Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints     high doses of radiation directly to cancer. Standard radiation (or photon radiation) is     commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is     a special type of radiation only available at a few institutions in the US and has not been     previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy     of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.      In this study, the investigators are evaluating the safety and effectiveness of proton-based     SBRT for early-stage NSCLC located in the periphery of the lung.   "
134417|NCT01525433|"     In this study, 400 Hispanic women will be recruited and randomized to one of three     interventions:        1. Control (no change);        2. A low-intensity information program, consisting of a video approach educating women on          the importance of cervical cancer screening;        3. A higher intensity program consisting of the video plus a 'promotora' or lay-community          health educator led intervention at the participant's home to encourage cervical cancer          screening.      The investigators will compare which intervention is most effective in encouraging Hispanic     women to undergo cervical cancer screening (Pap test)   "
134418|NCT01525420|"     The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation     outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).      Implementation outcomes:        -  end of treatment and 6-month follow-up data retention rates;        -  intervention implementation quality;        -  number & length of calls completed.      Comparison of each arm's implementation   "
134419|NCT01525407|"     This phase II trial studies donor atorvastatin treatment for the prevention of severe acute     graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem     cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a     donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the     patient's immune system reject the donor's stem cells. When the healthy stem cells from a     donor are infused into the patient they may help the patient's bone marrow make stem cells,     red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a     donor can make an immune response against the body's normal cells. Giving atorvastatin to the     donor before transplant may prevent this from happening.   "
134420|NCT01525394|"     This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled,     three-treatment, three-way crossover study in healthy subjects. There are two phases in this     study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening     and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1,     Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion     of study termination procedures will be performed at Visit 11.   "
134421|NCT01525381|"     Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by     a physician within the previous five years. It will be determined what diagnostic tests were     initially performed to make this diagnosis. Participants will undergo lung function testing     over 6-8 weeks to determine their respiratory status and to confirm they have asthma.     Participants may be followed up to one year depending on their test results.   "
134833|NCT01519986|"     The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3     (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal     associated with the administration of the supplement.   "
134449|NCT01524991|"     Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab     has shown intriguing activity as neoadjuvant therapy in patients with clinically localized     bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus     ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more durable     responses and improved outcomes.   "
134450|NCT01524978|"     This open-label, multi-center study will assess the efficacy and safety of Zelboraf     (vemurafenib) in patients with BRAF V600 mutation-positive cancers (solid tumors and multiple     myeloma, except melanoma and papillary thyroid cancer) and for whom Zelboraf is deemed the     best treatment option in the opinion of the investigator. Patients will receive twice daily     oral doses of 960 mg Zelboraf until disease progression, unacceptable toxicity, or withdrawal     of consent.      The safety and efficacy of Zelboraf in combination with cetuximab in a subset of patients     with colorectal cancer will also be assessed.   "
134422|NCT01525368|"     Cognitive training has been shown to be successful in patients with amnestic mild cognitive     impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a     randomized controlled trial, the investigators recently found that aMCI patients receiving a     cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active     control group showed pronounced hypometabolism on follow-up scans in regions typically     affected in AD.      Previous studies indicate that not all patients respond equally well to a cognitive     intervention. Identifying factors that predict response to treatment could help selecting     patients for a targeted intervention. A potentially important predictor is cognitive reserve     defined as premorbid cognitive performance. The hypothesis is that different levels of     cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different     neurostructural and neurofunctional correlates and influence treatment response in a     different way. Moreover, the impact of white matter lesions on treatment effects will be     investigated.      The investigator will perform a complex cognitive training program. Forty patients with aMCI     (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this     study. Since the patients are recruited consecutively, an estimated overall number of 80 will     be included and receive the training of whom about 40 will meet the inclusion criteria for     our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be     used to analyze the potential impact of white matter lesions on response to the intervention.     Cognitive effects of the intervention will be evaluated by neuropsychological testing.     Neurofunctional and neurostructural changes depending on cognitive reserve will be measured     using resting state fMRI and diffusion tensor imaging (DTI).      For comparison, a group of 30 aMCI patients will be recruited as an active control group     receiving study investigations (neuropsychological testing as well as MRIs), and exercises     for self-study at home, not the complex cognitive intervention.   "
134423|NCT01525355|"     Performing an EUS prior to ERCP in the setting of a positive intraoperative cholangiogram     will identify and risk stratify patients for the presence of CBD stones and strictures.   "
134424|NCT01525329|"     This randomized, intra-patient comparative study is designed to investigate the combination     regimen of 5-FU and PDT, versus PDT alone, for its ability to generate significantly elevated     levels of the target photosensitizer, PpIX, in lesions of actinic keratoses (AKs) and to more     effectively treat and prevent recurrence of AKs. The target population comprises patients     with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects     to control for possible influences of immunosuppression.   "
134425|NCT01525316|"     The investigators propose a clinical trial in premature infants to determine the effect of     orally-administered bovine lactoferrin on occurrence of severe infections and to determine     whether as a result of decreased infections, infants' growth and development improve after     daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties.     If successful, the use of lactoferrin as a protective protein could profoundly affect     clinical care of neonates both in the developed and developing world.   "
134426|NCT01525303|"     This proposed study seeks to examine whether adding an aerobic exercise prescription to a     behavioral treatment program for chronic headaches will improve headache frequency and     intensity, headache-related disability, and mood. It is hypothesized that participants who     receive the exercise prescription at the start of treatment will show greater gains than     those who receive the prescription halfway through treatment. It is also predicted that     participants who begin the exercise component halfway through treatment will demonstrate     greater improvement in the second half of treatment compared to the first half.   "
134427|NCT01525290|"     WAKE-UP is an investigator initiated European multicenter randomized controlled clinical     trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset,     e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove     efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking     up with stroke symptoms or patients with otherwise unknown symptom onset.   "
134428|NCT01525277|"     Whether the side of implantable CVCs was associated with the complication rates remains     unclear. The investigators plan this study to explore this issue by randomizing patients to     receive CVC implantation at the left subclavian or righ subclavian vein.   "
134429|NCT01525264|"     Breast cancer is the most commonly occurring cancer and most common cause of cancer mortality     among Korean American (KA) women, but mammography utilization among KA women remains     suboptimal. Most breast cancer screening studies with KA women have been descriptive and     correlational. Therefore, in this 4-year project, the effects of Korean Immigrants &     Mammography—Culture-Specific Health Intervention (KIM-CHI) on adherence to recommended breast     cancer screening protocols were tested. The specific aims are to: (1) compare the group     receiving KIM-CHI with an attention control group on mammogram attainment outcomes including     number of mammograms obtained (0, 1, or 2) and if obtained, length of time to obtain the     first mammogram, at 15 months using survival analysis; (2) compare the two groups on the     mediating variables of health beliefs, knowledge, self-efficacy, and spousal support at 2     weeks, 6 months, and 15 months using repeated measures multivariate analysis of variance; and     (3) identify the mediating effects of health beliefs, knowledge, self-efficacy, and spousal     support at 2 weeks on mammogram attainment outcomes at 15 months, using structural equation     modeling. Data on mammography attainment and the mediating variables were collected at     baseline and at 2-weeks, and 6- and 15-months post-baseline.   "
134445|NCT01525056|"     The purpose of this study is to evaluate the accuracy of Positron emission tomography,     Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal     cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging     studies will be compared to standard imaging studies and the histopathology of the surgical     specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases     pretreatment better than standard pretreatment scans and will better determine the degree of     response of the primary rectal tumor to preoperative chemoradiation.   "
134446|NCT01525043|"     The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients     with lateral and medial epicondylitis and compare it to Naproxen sodius.   "
134430|NCT01525251|"     Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in     Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the     survival rate in Western countries, the treatment in Taiwan needs more efforts to improve.     According to the report from the Childhood Cancer Foundation ROC, several children with     neuroblastoma did not complete their treatment and or not received the protocol. In addition     to the efforts in improving protocol, the reasons for those who drop-out and do not receive     complete treatment need the investigators more attention to think of.      Purpose of Study: The main purpose is to evaluate the effects of nurse case manager model on     caregivers' adaptation of disease uncertainty about then child with neuroblastorna.      Methods: A longitudinal and prospective design will be used to perform this study.     Questionnaire survey and chart review will be the means of data collection for the part of     quantative analysis. The qualitative method , semi-structural interview , also will be used     to collect data regarding caregiver's perception of social support and adaptation at the same     time of self-report of questionnaires survey .There are five points of time to collect data:     Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after eligible     subjects agree to participate in the study.      Subjects: The study will use a convenience sample. Once the caregiver's child is on has been     diagnosed with neuroblastoma will be recruited in this study.      Instruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the     self-reported socio-demographic questionnaire will be used to collect data. Process recording     will be typed once finishing interview for further analysis.      Data Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The     data will be analyzed using descriptive statistics and inferred statistics. Content analysis     and theme formation will be categorized to assist the interpretation of quantitative results.      Implication: The findings of this study will be expected of the effects of nurse care manager     model on children with newoblastoma cancer survivors.   "
134431|NCT01525238|"     The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin     in pediatric subjects with type 2 diabetes mellitus (T2DM)   "
134432|NCT01525225|"     The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy     Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM)     following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet     and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets   "
134435|NCT01525186|"     Background:      A topic of interest in the etiology of child obesity is if and how parental feeding behaviors     are associated with child food intake and weight status.      Objectives:      The objective was to explore if and how directive (overt) and non-directive (covert and food     environmental structure) types of parental feeding control were associated with children's     food intake and weight status.      Design:      This was a cross-sectional, exploratory study using structural equation modeling to determine     directional associations between maternal feeding practices and their child's food intakes     and weight status. Researchers collected data from 330 dyads of 3-5yr children and mothers     participating in a federal preschool program for low-income families (Head Start) in     Michigan. Mothers' feeding practices (directive and non-directive control), children's food     intakes, height and weight of both mothers and children were measured. Structural equation     models tested the relationships between maternal feeding practices, the child's food intake     and weight status.      Hypotheses:        1. Child weight is negatively associated with parents' directive feeding control practices.        2. Less directive control or greater non-directive control is associated with healthier          food intakes in children.   "
134436|NCT01525173|"     This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic     solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine     tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated     with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular     pressure (IOP) lowering medication.   "
134437|NCT01525160|"     Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of     females.      OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping     breathing at night). As well as affecting tiredness, mood, concentration and quality of life     - there is growing concern that it can increase the risk of high blood pressure, heart     problems, strokes and thromboses (clots in the veins).      It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily     it also causes damage to the lining of the blood vessels (endothelial injury). These effects     seem independent of other risk factors such as obesity, smoking, family history of clots etc.      The investigators are testing new biomarkers: gel point and fractal dimension developed at     the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a     similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies     (Controls) Also markers of vascular inflammation are being measured.   "
134438|NCT01525147|"     A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I     clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in     healthy male volunteers   "
134439|NCT01525134|"     The purpose of this study is to evaluate the accuracy, diagnostic yield, operational     performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test     in detecting tuberculosis in HIV-infected adults.      A secondary study objective is to determine the accuracy, efficiency, costs, and     cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including     the novel Xpert MTB/Rif test.   "
134440|NCT01525121|"     This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage     compression technique improves respiratory mechanics and is effective in secretion removal in     mechanically ventilated patients.   "
134441|NCT01525108|"     In this study the investigators aim to evaluate the effect of home-based blood pressure     measurement with an electronic device on medication adherence and blood pressure control.   "
134442|NCT01525095|"     The purpose of this study is to assure the uniform collection, handling, storage and     transport of patient whole blood specimens and associated information to support validation     of the T2 Candida Assay.   "
134443|NCT01525082|"     The purpose of this research is to evaluate the effectiveness and safety of a combination of     capecitabine, temozolomide and bevacizumab in the treatment of advanced pancreatic     neuroendocrine tumors.   "
134444|NCT01525069|"     This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial     infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic     drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by     surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver     tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or     gemcitabine may significantly improve clinical outcomes of patients with locally advanced     cholangiocarcinoma.   "
134447|NCT01525017|"     The primary objective of this study is to answer the question Is it possible to inject the     Combig-DC vaccine in a renal tumour without getting unacceptable side effects? Patients     newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two     occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will     be eliminated. Adverse events will be registered, as well as changes in vital signs(heart     rate, blood pressure and body temperature) and lab parameters. Immunologic response will be     evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size     of the metastases three months after nephrectomy.   "
134448|NCT01525004|"     This is a phase I trial in which the both the safety and immunogenicity of the standard dose     flu vaccine will be compared with high dose flu vaccine in children that have undergone solid     organ transplantation (SOT).   "
134526|NCT01523990|"     A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1     Infected Patients   "
134451|NCT01524965|"     Open reduction and locking plate osteosynthesis is a commonly used and well-accepted     treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff     despite intensive rehabilitation, limiting the function of the upper extremity and decreasing     the quality of life. The accepted postoperative mobilisation protocol includes passive     exercises until six weeks postoperatively and active range of motion exercises after that.     There is good evidence that conservatively treated fractures of the same site heal better and     faster if mobilised immediately. The study compares standard mobilisation versus     immmediate mobilisation in a prospective, randomized, controlled trial in order to find the     optimal time-frame for physiotherapy to produce best possible results. Outcome measures are     assessed at specific time points after the operation and comparisons between groups are made     to follow the rate of recovery and end results.   "
134452|NCT01524952|"     Objective:      It is unclear whether prolonged electrical muscle stimulation can improve cardiorespiratory     fitness and reduce body fat in obese subjects. The purpose of this study is to investigate     the effect of prolonged combined thermal and electrical muscle stimulation (cTEMS) on peak     oxygen consumption (VO2 peak) and body composition. We will also investigate the biochemical     effects and the resultant lipolysis-related gene expression changes in adipocytes.      Methods:Eleven obese (BMI≥30) individuals will receive cTEMS in three 60-minute sessions per     week for 8 weeks. Activity levels and dietary habits will be kept unchanged and controlled     with an accelerometer and nutritional questionnaire. Before and after the stimulation period,     functional capacity are assessed by VO2 peak, and body composition was assessed by     dual-energy X-ray absorptiometry and bioelectrical impedance analyses. Lipolytic activity     will be determined in abdominal adipose tissue by 24 hours of microdialysis on a sedentary     day, and adipose tissue biopsies will be taken for the gene expression analysis.   "
134453|NCT01524939|"     The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin     Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.   "
134454|NCT01524926|"     The study will primarily assess the antitumor activity of crizotinib in a variety of tumors     with alterations in ALK and/or MET pathways. The targeted patient population will include     patients with tumors harboring specific alterations leading to ALK and/or MET activation,     where tyrosine kinase inhibitors against these targets have not yet been adequately explored.   "
134455|NCT01524913|"     The purpose of this study is to determine whether the administration of hyaluronic acid or     corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain     relief and improved function.      The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the     mean visual analogue scale (VAS) at one month when compared to celestone and placebo.   "
134456|NCT01524900|"     This Post Marketing Surveillance study will be performed as an open-label, prospective,     non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected     patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine     extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and     pre-treated patients switching from nevirapine immediate release or other anti-retroviral     therapy (ART) will be included in the study. The decision to initiate treatment with     nevirapine extended release is independent of this study and is based entirely on individual     patient need and the judgement of the treating physician. The aim of the study is to assess     the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1     infected patients in routine clinical practice. It is planned to document five visits for     each patient over a twenty four week observational period.   "
134457|NCT01524887|"     The purpose of this study is to provide evidence of efficacy and safety to support the     development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s     Disease.   "
134458|NCT01524874|"     The importance of vitamin D (VitD) in the prevention and treatment of human health conditions     has gained increased attention in recent years. As a result, medical providers of all     categories are screening clinical VitD status frequently, yet become challenged with how to     best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement     is most effective. It has been recognized that to achieve significant effects - serum     concentrations >30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend     substantially higher doses than were previously thought sufficient. These higher doses can be     easily achieved orally. This clinical trial aims to compare absorption of three available     forms of this fat-soluble vitamin, due to the potential differences in absorption of     different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily     available as supplements, yet these have not been systematically compared. This three-arm,     randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol     (25-OH)D concentration between the three arms at baseline and after random administration of     one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The     investigators hypothesize that the three forms of vitD will result in an equivalent increase     in serum 25OHD.   "
134518|NCT01524094|"     The purpose of this study is to see if there is a difference in survival between two     different treatment strategies for colorectal peritoneal surface disease. The control arm     administered the currently considered standard treatment which is palliative systemic     chemotherapy. The experimental arm received the combination treatment cytoreductive surgery     and intraperitoneal chemotherapy. The investigators hypothesis is that the combination     treatment will improve the overall survival.   "
134475|NCT01524653|"     Patients with cancer have a high risk of developing venous blood clots or thromboembolism     (VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis     (protective treatment for blood clots), numerous studies have identified serum biomarkers for     risk of future VTE. There is also increasing evidence pointing to a prophylactic effect of     statin therapy on the risk of developing VTE in high-risk populations including patients with     advanced cancer. The purpose of this research study is to find out whether treatment with     rosuvastatin (the study drug) reduces the risk of VTE in patients with cancer receiving     chemotherapy. This study is specifically investigating the impact of rosuvastatin therapy on     serum biomarkers (D-dimer and others) that indicate a risk for VTE, as well as safety and     tolerance of rosuvastatin therapy in this population.      This is a phase II randomized crossover study with two 3-4 week treatment periods during     which all enrolled patients will receive 20 mg of rosuvastatin once a day by mouth or a     matching placebo tablet. Approximately two tablespoons of blood will be collected for     biomarker analysis at the beginning and end of each treatment period. After the first     treatment period there will be a 3-5 week break where subjects will undergo a washout.     Following this washout period every subject will crossover or begin taking the alternative     therapy so everyone enrolled will receive the study drug either during the first or the     second treatment period. Biomarker levels will be analyzed in both treatment periods and     compared to baseline, with every patient acting as their own control.   "
134459|NCT01524861|"     Stress (tako-tsubo) cardiomyopathy (SC) is a rapidly reversible form of acute heart failure     reported to be triggered by stressful events and associated with a distinctive left     ventricular (LV) contraction pattern.      SC mimics acute coronary syndrome and is accompanied by reversible left ventricular apical     ballooning in the absence of angiographically significant coronary artery stenosis.     sympathetic activity dysfunction appears to play a very important role in the pathophysiology     of takotsubo cardiomyopathy.      In most cases, myocardial scintillography with 123Imetaiodobenzylguanidine (MIBG) showed     altered captation of the radiotracer in several heart segments. In particular, the apical     myocardium has poor sympathetic innervations and an uptake reduction in MIBG tracer.      A hypothesis for this finding could be that the intense discharge of adrenalin, acting on     heart segment with different and abnormal innervation, may produce a transient heart failure     characterized by a particular shape of the left ventricle.      While studies have shown that heterogeneous MIBG distribution, decreased MIBG uptake and     increased norepinephrine content were completely prevented by α-lipoic acid or by L-acetyl     carnitine administrations in diabetic cardiomyopathy, no studies have examined the effects of     these therapies on tako-tsubo cardiomyopathy.      On this basis, the investigators study will evaluate whether the dysfunction of adrenergic     cardiac innervation, evaluated by MIBG, persist after previous experience of transient     stress-induced cardiac dysfunction. Moreover, the investigators will assess whether the     medications that restore sympatho-vagal alterations in diabetic cardiomyopathy, such as     α-lipoic acid and L-acetyl carnitine, will improve the adrenergic cardiac innervation, in     patients with SC.   "
134460|NCT01524848|"     Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who     develop resistance against the two hitherto approved drugs for this disease, the tyrosin     kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further     response may be achieved by other drugs, mainly other TKIs, which have been explored in     different studies but not yet have been approved for clinical use. Pazopanib is a TKI     inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles     in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves     investigational trials. The drug is approved for metastatic renal cancer and is relatively     well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12     weeks of treatment will be assessed as the primary endpoint, and at the same time trough     levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control     rate in relation to trough level week 12 and in relation to the primary mutation of the tumor     (if known). The goal is to include 72 patients in the trial, which is open and single arm.   "
134461|NCT01524835|"     This study will gather information on the long-term effects of donating a lung lobe on living     donors.   "
134463|NCT01524809|"     This trial is conducted in Europe. The aim of this trial is to investigate steady state     pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects     with type 1 diabetes.   "
134464|NCT01524796|"     Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the     treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.   "
134465|NCT01524783|"     The purpose of this study is to compare the antitumor activity of everolimus plus best     supportive care versus placebo plus best supportive care in patients with advanced     nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.   "
134466|NCT01524770|"     The study involves 2 injections of 1.5 milligrams (mg) dulaglutide, 1 given by a pre-filled     manual syringe, the other given by an auto-injector. Injections will be separated by a     minimum 28-day washout period. The study will evaluate if the levels of drug in the blood are     similar when given by each method. Participation in the study is likely to take approximately     7 weeks, not including screening.   "
134476|NCT01524640|"     This is a randomized, double blind, placebo controlled trial to confirm the safety and     determine the immune response of the killed oral cholera vaccine in healthy adults and     children in Ethiopia.   "
134477|NCT01524627|"     Varenicline is the best smoking cessation agent to date; however it is only effective in a     subgroup of smokers and is associated with undesirable side effects in other subgroups. To     understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion     functional magnetic resonance imaging and a functional candidate gene association approach     using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic     varenicline administration in smokers. Brain and behavioral responses to smoking cues will be     will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat     smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats.     For the purposes of the clinical trial portion of the study, the change from cigarettes per     day at Baseline to the last day of treatment will be reported.   "
134467|NCT01524757|"     Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in     excessive iron overload causing damage of different important organs like heart, liver,     pancreas and joints. Complications and symptoms can regress by intensive treatment reducing     the iron overload stores.Different genes have been identified playing a role in the     pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y,     located on chromosome 6. Phlebotomy is currently the standard therapy which consists of     removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients     between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L.     Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed.      For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the     ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that     HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in     a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.      Research question: The primary objective is to determine the effectiveness and cost     effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron     overload in HH patients.      Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center,     Maastricht university medical center ) and hospital in Belgium (University Hospital     Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up     will be one year.      Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the     ferritin level is measured and decided if the patient need a phlebotomy (Ferritin >100 µg/L).   "
134468|NCT01524744|"     The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on     erosive-atrophic 0ral lichen planus in a randomized clinical trial study.   "
134469|NCT01524731|"     Dexamethasone is a synthetic corticosteroid that has been proven to be effective and     relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV).      However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis     after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA     surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this     question, the investigators will conduct a randomized, double-blinded placebo-controlled     trial with two different doses of dexamethasone in women undergoing elective gynecologic     laparotomy.   "
134470|NCT01524718|"     Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with     a world wide annual incidence of approximately 1.7 million. These fractures are associated     with substantial morbidity and mortality. As populations age and life expectancy increases     worldwide, the incidence of these fractures is likely to raise, expected to triple in the     next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral     part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of     contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a     major slice of the total radiation dose. Optimal positioning and control of the imaging     intensifier device may result in significant reduction of radiation dose and time and in     substantial shortening of the procedure.      The investigators hypothesis is that this technique would substantially shorten procedure     time and reduce unnecessary radiation exposure for both the patient and the medical staff.     Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy     technician during the surgery, as there is no need to alternate fluoroscopy views.   "
134471|NCT01524705|"     Results of recent studies using standard long and short acting insulin therapy (Basal - Bolus     or BBI) in type 2 diabetes mellitus (T2DM) have not shown benefits to lower risks for heart     attacks, strokes, or eye, nerve and kidney problems. Some studies also show a long time     between the start of treatment and signs of benefit. This has led to a review of current ways     to normalize blood glucose control with basal bolus insulin and how to make blood glucose     better. Improving blood sugar with insulin therapy usually causes weight gain, more high     sugar levels after meals, and more low blood sugars. Early studies suggest that when people     take long-acting insulin and metformin, they have fewer blood sugar extremes when they also     take a new type of medicine called glucagon-like polypeptide-1 (GLP-1) agonist named     exenatide (Byetta), instead of meal-time insulin. This means there might be a better way to     treat Type 2 diabetes.      Participants are asked to take part in an eight month study to find out if middle-aged and     older people with Type 2 diabetes who have added risk factors for heart disease can even out     their blood sugar levels. They will start on long-acting insulin, mealtime insulin, and     metformin, if they are not already on these medications. Their kidney function tests must be     normal and they must not be allergic to metformin. Then, after a 2 month run-in phase, they     must be willing to be assigned by chance into one of two groups. This means that they will     have a 50/50 chance (like flipping a coin) of being in either group. Half of them will be     started on the new medicine known as Byetta rather than the meal-time insulin and the other     half will remain on the meal-time insulin during the next 6 months (26 weeks) to see which     group has more steady blood sugars. They will be asked to use a continuous blood sugar     monitoring system called DexCom. A sensor is inserted under the skin in the same areas the     insulin is injected. The DexCom can check their blood sugars 24 hours of the day and night     and will be worn until 7 days of recordings are collected. In the same 7 day period, they     will also be asked to wear a Holter or Telemetry monitor that will record their heart beats     and rhythm which will be compared to the blood sugar readings. They will also use home     glucose meters to check their glucose levels about 3 to 4 times a day. The study will take     place at 12 centers in the United States and enroll about 120-130 people.   "
134472|NCT01524692|"     The purpose of this study is to improve survival of patients with recurrent or metastatic     Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational     drug, TKI258, in treating ACC.   "
134473|NCT01524679|"     A prospective, randomised, open-label phase IIb clinical trial assessing the effect of     pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing     nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B      The primary objective of the trial is to investigate whether the add-on of pegylated     interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the     percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48     weeks.      170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an     oral antiviral regimen and having a nondetectable viral load for at least 12 months are     included.   "
134474|NCT01524666|"     This is a nonblinded Case-only study that evaluates the effects of Agmatine Sulfate on small     fiber peripheral neuropathy. Patients will be started on Agmatine sulfate (a metabolite of     Arginine) and monitored for two months. Improvement will be noted on their response to the     Neuropathic Pain Questionnaire. Additionally the investigators will note improvement by     performing autonomic function testing at the beginning and end of the study.   "
134570|NCT01523418|"     The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis     of VTE in Indian patients undergoing elective TKR/THR   "
134478|NCT01524614|"     Upper airway obstruction (UAO) is common complication during induction of general anesthesia.     The mechanism of UAO during anesthesia has not been well understood. Posterior displacement     of soft palate are believed to be the primary contributing factors. The mechanism of UAO     during anesthesia share many similarities with obstructive sleep apnea (OSA). Since nasal     continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with     OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the     incidence and severity of UAO.   "
134479|NCT01524601|"     Renal transplant recipients need life long immunosuppression and one of the new drugs is     everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects     are increased blood cholesterol levels. Many renal transplant recipients are treated with a     cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering     drug on the market with a potential higher cholesterol lowering potency. In the present study     the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels     more than fluvastatin in renal transplant patients.   "
134480|NCT01524588|"     Follicle-stimulating hormone (FSH) is used in medically assisted procreation, to induce an     ovarian stimulation in women. However, the FSH dose that has to be injected is quite hard to     adjust, because an excess of exogenous hormone could lead to very severe complications for     patient. This hormone acts on its cognate receptor, the FSHR, present on the granulosa cells     surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain.      The investigators first aimed to research in the c-terminus part of the receptor the presence     of allelic variants that could explain the variations of response to FSH stimulation.      The investigators also would want to complete the data already known on a functionally     determinant single nucleotide polymorphism on 680 position in the c-terminus part of the     hFSHR.      Then, the investigators would analyze the entire sequence of the hFSHR of patients presenting     an unusual phenotype in response to FSH treatment, in order to detect a potential mutation     involved in the receptor functionality.      The results of this study could allow us to increase our knowledge on the hFSHR physiology     and functionality, in order to adjust treatment to the genetic profile of patients.   "
134481|NCT01524575|"     The goal of this clinical trial is to improve and personalize pancreatic cancer care to     deliver the most effective therapy while avoiding unnecessary exposure to potential side     effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression     predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are     much more likely to respond to cisplatin than those whose tumors produce large amounts. The     hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective     regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of     ERCC1.   "
134482|NCT01524562|"     Background:      - Liver disease is a leading cause of death in people who have the human immunodeficiency     virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most     research on HIV-related liver disease has been conducted in North America and Europe.     However, HIV-related liver disease in Uganda and other African nations may involve other     diseases that are not common in the West, and may not involve hepatitis B or C. Researchers     want to study HIV-related liver disease in Uganda to learn more about the differences between     Western and African trends of this disease.      Objectives:      - To study HIV-related liver disease in rural Uganda.      Eligibility:        -  Individuals at least 18 years of age who were tested for possible liver disease. Some          participants will have HIV infection; others will be uninfected.        -  All participants will be from rural areas of Uganda.      Design:        -  Participants will have at least two study visits.        -  Participants will have a physical exam and medical history. They will complete a          questionnaire about health and quality of life. Blood, urine, and stool samples will be          collected. Participants will also have a liver scan to check for liver scarring, and an          ultrasound to take images of the liver.        -  Participants who may have liver disease will visit a local hospital for more tests. A          liver biopsy will be performed to collect liver tissue samples.   "
134483|NCT01524549|"     Background:      - The endothelium is the inner lining of blood vessels. The cells in this lining help     regulate blood flow and immune system function. Problems with endothelial cells can     contribute to heart disease, high blood pressure, and diabetes. Certain genes or parts of     genes may be related to problems with endothelial function. Researchers want to study healthy     adults who have genes that may affect their endothelial function. More information on these     genes may provide more information on genetic risk for certain diseases.      Objectives:      - To study healthy adults who have genetic markers related to endothelial cell problems.      Eligibility:        -  Healthy volunteers between 18 and 65 years of age.        -  Current participants of the Environmental Polymorphisms Registry and have certain genes          related to endothelial cell problems.      Design:        -  Participants will have a single study visit to collect information and samples.        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have an ultrasound of the artery in the arm and will be given a          short-acting medication called nitroglycerin to study blood flow and blood pressure.   "
134484|NCT01524536|"     Background:      - Hypereosinophilic syndrome (HES) is a disorder in which the body has too many eosinophils     (a type of white blood cell). Too many eosinophils in HES can cause damage to the heart,     nerves, or skin. Certain drugs can help lower eosinophil counts to prevent tissue damage.     Corticosteroids, such as prednisone, are used for initial therapy in this disorder. Although     most people respond to prednisone, some people develop side effects from it, or do not     respond very well to treatment. Better ways of determining the dose to give could help to     decide on the best therapy for HES.      Objectives:        -  To determine whether a single-dose of prednisone can be used to predict which people          with hypereosinophilia respond to treatment.        -  To study lack of response to steroid treatment in people with HES.      Eligibility:      Inclusion criteria:        -  Individuals with hypereosinophilic syndrome with high eosinophil counts.        -  Individuals who are willing to have blood drawn before and after getting steroids.      Exclusion criteria:        -  Individuals who are on more than 10mg of prednisone (or similar drug)        -  Individuals with hypereosinophilic syndrome who are on other medications that could          interfere with the study        -  Women who are pregnant or breast-feeding        -  Individuals who have a known gene mutation associated with chronic eosinophilic leukemia        -  Children less than 18 years old who weigh less than 48kg or 106lb      Design:        -  Participants will have a screening visit with a physical exam and medical history. Blood          and urine samples will be collected.        -  Participants will have a single dose of the steroid prednisone by mouth in the morning.          Blood samples will be collected 4 hours after this dose.        -  On the day after the steroid dose, participants will provide another blood sample in the          morning.        -  Participants will start to take prednisone daily when they return home. Blood samples          will be collected weekly at the participant s doctor s office. The dose of prednisone          will be lowered depending on the weekly eosinophil count. We will try to get each person          on the lowest dose of prednisone possible that will control the disorder. Participants          who do not respond or have severe side effects will be taken off prednisone. Other          treatments will be considered for people who do not respond to steroids. The goal is to          evaluate the response to prednisone. Our research will try to figure out why some people          do not respond to steroids. Most people will complete the study within 6 to 16 weeks,          depending on their response to prednisone.   "
134485|NCT01524523|"     Background:      - Many people feel pain during and after bone marrow aspiration (collection). Studies suggest     that pain may be related to different kinds of inflammation, or the presence of nitric oxide     (a normally occurring gas) in the body. Researchers want to study nitric oxide levels in the     blood and breath before and after bone marrow collection. They will look at how these levels     relate to feelings of pain.      Objectives:      - To better understand pain related to having a bone marrow collection.      Eligibility:      - Individuals at least 18 years of age who are enrolled in a study that requires bone marrow     collection.      Design:        -  Participants will be screened with a physical exam, medical history, and blood sample.        -  Participants will provide study blood and breath samples to check nitric oxide levels.          Participants will also have a test to measure skin sensitivity to heat and touch.        -  During the collection, participants will keep track of their pain levels.        -  After the collection, participants will keep track of any pain medications they take.          They will also record if and when they eat any foods that contain nitrates for about 24          hours.   "
134486|NCT01524510|"     In this open prospective study 40 patients who received Mandibular Replacement Appliance     (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be     included. The patient's sleep will be registered during 2 periods of 2 days: one while the     patient does not wear the MRA and, +/- 1 week later, one while the patient wears the MRA.     Furthermore, 2 low dose CT scans (one with and one without the MRA device in the mouth) will     be taken. These data must allow the investigators to validate the use of functional imaging     (segmentation and Computational Fluid Dynamics) as a predictor of the outcome of the MRA     therapy in OSAHS patients.   "
134487|NCT01524497|"     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to     evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for     treatment of depression in Chinese population.   "
134488|NCT01524484|"     Data on quality of clinical anesthesia are important for the improvement of both quality and     patient safety in this field. Routine quality data are often collected by professionals busy     with patient care. This study examines the reliability of routinely collected quality data by     comparing the electronic anesthesia record with the respective reports on quality-indicating     events, i.e. whether events during the anesthetic (e.g., drop of blood pressure, irregular     heart rhythm, and others) were actually reported or not. Additionally, interviews with     reporting staff (physicians and nurses) are performed to gain insight in possible obstacles     to reporting during the working process.   "
134489|NCT01524471|"     Spastic esophageal motility disorders induced significant symptoms including dysphagia,     retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel     approach to perform myotomy through the esophagus with long submucosal tunnel. This study     aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from     animal study to clinical practice in human.   "
134490|NCT01524458|"     rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to     patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The     commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive     lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES).     Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary     esophageal motility disorder in which the LES failed to relax with increased pressure.     Currently the standard treatment for Achalasia and spastic motility disorders is Laparoscopic     Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery (N.O.T.E.S.) has     lead to a new way to perform myotomy - Peroral Endoscopic Myotomy (P.O.E.M.). Basically,     through mucosal incision, a submucosal tunnel is created after identification of the level of     gastroesophageal junction. Myotomy will be performed with endoscopic instruments and the     entrance site will be closed with clips.   "
134491|NCT01524445|"     The purpose of this retrospective study is to collect information about patients who received     bortezomib as their first chemotherapy and who responded well to it, but who relapsed     afterwards and were treated again with bortezomib a second time after a treatment-free period     of at least 6 months. During this non-interventional study (this means that no drug is being     tested in this study) the safety and effectiveness (whether it works or not) of bortezomib     re-treatment will be evaluated in patients with multiple myeloma. Only data already mentioned     in your clinical file will be collected. About 100 adult patients will take part in the study   "
134492|NCT01524432|"     This is a study of hygienic socks with antifungal agent-loaded microcapsules for subjects     with interdigital type tinea pedis (athlete's foot between the toes). This is a 6 week study     which has a 2 week treatment period and a 4 week follow-up evaluation.   "
134493|NCT01524419|"     1. Increased women's involvement in decision making at labor process correlates with a          positive perception of the labor process.        2. Increased maternal satisfaction with midwifery and gynecological care at labor          correlates with a more positive perception of the labor process.   "
134494|NCT01524406|"     This is a safety and tolerability study investigating the effect of HPP593 in healthy     volunteers during and after limb immobilization.   "
134495|NCT01524393|"     Occurrence of venous thromboembolism during in Vitro Fertilization (IVF) pregnancies has been     reported in numerous case reports and in two small consecutive series. The incidence of     venous thromboembolism (VTE) after IVF has been claimed to be comparable to the incidence of     VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE).      The aim is to estimate and compare the risk of both PE and VTE during the the different     phases of pregnancy after IVF to that in age and period matched control women. The     investigators will use the Swedish National Health Registers to estimate the risk.   "
134496|NCT01524380|"     A double-blind, randomized, placebo-controlled trial of ginkgo biloba extract (Egb-761) as an     add-on therapy to risperidone compared to risperidone plus placebo in the treatment of 200     treatment-naive first-episode patients with schizophrenia. The study addresses an immune     dysfunction hypothesis of schizophrenia.   "
134645|NCT01522430|"     The DEPART study end points are to provide conclusive evidence, using a randomized, double     blinded, sham procedure controlled study design, that radiofrequency renal denervation:        1. reduces daytime ambulatory blood pressure,        2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.   "
134497|NCT01524367|"     Excitement during the emergence from general anesthesia is a great post-operative problem. It     may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage,     self-extubation, and removal of catheters, and it can necessitate physically or chemically     restraining the patient. It has been reported that the incidence of postoperative emergence     excitement in adults after general anesthesia is 21.3% occurrence.      Many things are mentioned as risk factors for emergence excitement. Among them, excitement     after orthognathic surgery (two-jaw) was more common than after other types of surgery. The     patients undergoing emergence with nasotracheal intubation after orthognathic surgery may     have a sense of suffocation during emergence from anesthesia, which may increase the     incidence of emergence excitement.      Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an     S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1)     compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.      To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement     was investigated only in children.      The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence     and the severity of the emergence excitement in adults with nasotracheal intubation after     orthognathic surgery (two-jaw).   "
134498|NCT01524354|"     The aim of our study was to evaluate the significance of monitoring anesthetic depth for the     conduct of anesthesia and the early postoperative period in patients subjected to surgical     correction of combined valvular disorders.   "
134499|NCT01524341|"     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria     patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day   "
134500|NCT01524328|"     The purpose of this study is to investigate the proportion of use of complementary and     alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). In addition,     the reason for, and satisfaction with use of CAM.   "
134501|NCT01524315|"     The objective of this study is to determine whether preoperative parenteral thiamin     supplementation does prevent the intra and early postoperative increase of lactate and     whether this effect is related to the extent of thiamine deficiency in patients undergoing     heart surgery. In addition the prevalence of major thiamin deficiency in patient undergoing     heart surgery will be determined.   "
134502|NCT01524302|"     This study will further analyze the use of ceftaroline for CABP and compare its potential to     eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of     ceftaroline compared to levofloxacin may be further highlighted from this investigation.   "
134503|NCT01524289|"     The objective of this study is to evaluate the efficacy and tolerability of adding     anacetrapib to ongoing statin therapy in participants with heterozygous familial     hypercholesterolemia.   "
134504|NCT01524276|"     The purpose of the Registry is to provide continuing evaluation and periodic reporting of     safety and effectiveness of Medtronic market-released products. The Registry data is intended     to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,     payers, and industry by streamlining the clinical surveillance process and facilitating     leading edge performance assessment via the least burdensome approach.   "
134505|NCT01523223|"     This phase I trial studies the side effects and the best dose of donor CD8+ memory T-cells in     treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may     also stop the patient's immune system from rejecting the donor's stem cells. The donated stem     cells may replace the patient's immune cells and help destroy any remaining cancer cells     (graft-versus-cancer effects). Giving an infusion of the donor's T cells (donor lymphocyte     infusion) after the transplant may help increase this effect   "
134506|NCT01524250|"     Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose     corticosteroids are already been chosen by the patient and the diagnosing physician will be     contacted for screening and enrollment. Patients will then be randomized to receive     equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve     function assessments will be compared at baseline, prior to treatment, one and six months     post corticosteroid treatment. This will allow for a comparison on whether the route of     medication plays a role in the effectiveness of treatment with high dose corticosteroids.   "
134507|NCT01524237|"     This study will be comprised of 2 parts, Part A and Part B, both in healthy male     participants.      Part A of the study will investigate the safety of intravenous (IV) ketamine administration     after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be     completed before starting Part B.      Part B of this study will investigate whether different dose levels of LY2979165 or     LY2140023, when administered before ketamine, result in changes to the images on a brain scan     seen with ketamine alone. Brain imaging is currently used for a number of reasons including     understanding where in the brain medicines have their effects. Ketamine is an anesthetic used     in this study to activate particular regions of the brain.      The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg     with matching dummy drug (placebo) for each dose.      The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose.      Screening is required within 28 days prior to the start of the study and follow up 7-14 days     after the last dose of study drug. The study will last up to 8-weeks for an individual     participant.   "
134508|NCT01524224|"     This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV)     LY2495655 in participants with advanced cancer.   "
134509|NCT01524211|"     The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular     stent-graft system for the treatment of aortic aneurysms.   "
134516|NCT01524120|"     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,     Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and     histologic features including patterns of inflammation, crypt abscesses and granulomas.     Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for     gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an optical biopsy     of the gastrointestinal mucosa during the endoscopic procedure.      The main objective of this study is to determine endoscopic and endomicroscopic features of     mucosal healing in patients with IBD.   "
134510|NCT01524198|"     Asthma is the most common chronic illness of childhood. About 10% of children are affected.     Not surprisingly, acute asthma exacerbations are one of the common reasons to visit pediatric     emergency rooms (ER). About 5.7% of all pediatric emergency room visits are due to acute     asthma exacerbation. Around 8% of those get admitted to the hospital. This constitutes huge     financial and administrative burden on the health care system.      Inhaled corticosteroids (ICS) is the gold standard prophylactic therapy for patients with     persistent asthma. In the setting of acute asthma exacerbation systemic steroids given early     in the course of treatment help decrease the rate of admission and return to the ER. However,     the anti-inflammatory action of corticosteroids, through which this effect is caused, takes 4     hours to start working. This is because it is mediated through genomic pathways where the     transcription of several inflammatory cytokines is suppressed. It was also shown that     corticosteroids can cause vasoconstriction through non-genomic pathways. The onset of this     action is as quick as 30-60 minutes. It is proposed that this action is mediated by blocking     the extraneuronal uptake (metabolism) of norepinephrine in vascular smooth muscle cells,     hence, making it available for re-use by the sympathetic neuronal cells.      Our objective is to compare the efficacy of adding repetitive sequential doses of budesonide     versus placebo (normal saline (NS)) to β2-agonist and ipratropium bromide (IB) combination     (standard treatment) in the management of acute asthma in children in the ER. We hypothesize     that the addition of budesonide to β2-agonist and IB in the management of moderate to severe     acute asthma in the ER is superior to the addition of placebo.   "
134511|NCT01524185|"     Children who have been exposed to trauma (defined as physical, sexual or emotional abuse,     neglect, exposure to life threatening events, domestic and community violence, parental     mental health disorders, substance abuse, and/or incarceration may also have parents who have     experienced trauma. Often, unresolved intergenerational trauma makes treatment of children     with trauma and its sequelae, including Post Traumatic Stress Disorder, attachment disorders     and dysregulation characterized by emotional lability, hyperarousal, and sleep and attention     disturbances, difficult to manage. FamilyLive (FL) is a promising treatment approach     developed by clinicians at the Kennedy Krieger Family Center (KKFC) over 10 years ago to     address the unique needs of families with unresolved and untreated histories of neglect and     disrupted attachment who need support to build skills for managing their children's responses     and behaviors. FL uses a team approach with a therapist in the room with the family and     call-in observations and clinical suggests from a clinician behind a one-way mirror. Through     the call-in process the treatment team provides validation, acknowledgement, support and     multiple perspectives for the family's experiences. The FL approach works with families to     improve parental self-care, stress management, emotional regulation and self-awareness.      Despite its clinical use at the KKFC, the effectiveness of the FL intervention not been     systematically evaluated using a randomized design. The proposed preliminary study will use a     randomized design to evaluate the feasibility of conducting a larger randomized trial of FL     compared to other standard mental health care treatments (SMHC) at the KKFC. We hypothesize     that it will be feasible to recruit sufficient numbers of clients for and conduct a     randomized controlled trial of FL on a cohort of children exposed to neglect and trauma. We     also hypothesize that FL participants will evidence greater reductions in heart rate     variability, behavior problems, trauma symptoms, and improvements in functioning compared to     participants in the SMHC.   "
134512|NCT01524172|"     This preliminary study will examine the feasibility of conducting a randomized clinical trial     of Yoga Based Psychotherapy (YBPG) and standard care mental health (SCMH) treatment compared     to SCMH for children ages 8-12 years who have a history of neglect and maltreatment (trauma).     The goal of the study is to inform the method and sample size for a larger randomized trial     to study the effect of YMBT with SCMH compared to SCMH in improving child regulation of     behavior, emotions, and daily functioning. Children who have experienced trauma, including     sexual abuse, physical abuse, emotional abuse, exposure to community or domestic violence,     parental substance abuse, mental health disorders, and incarceration are at risk to have     dysregulation of mood, emotions and behavior. In addition, children exposed to neglect and     trauma may have poor attachment to caregivers and poor peer relations. It is hypothesized the     using YBPG as an adjunct to SCMH may improve children's regulation of emotion and behavior.   "
134513|NCT01524159|"     The purpose of the study is to evaluate the effect of dietary supplementation of bromelain (a     proteolytic enzyme from the pineapple plant) on the reduction of plasma fibrinogen level     among type 2 diabetic subjects who have a high risk of cardiovascular disease.      The null hypothesis [Ho] is: there is no significant improvement in plasma fibrinogen, serum     lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for subjects     with type 2 diabetes who are at risk of CVD following the intervention of bromelain     supplementation compared to placebo group.      The alternative hypothesis [H1] is: there is a significant improvement in plasma fibrinogen,     serum lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for     subjects with type 2 diabetes who are at risk of CVD following the intervention of bromelain     supplementation compared to placebo group.   "
134514|NCT01524146|"     Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in     the United States. Several European studies have reported the efficacy and safety of     Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported     the same in the United States.      The establishment of a registry to capture all PDT cases within and outside US can help the     investigators evaluate a larger and non-ambiguous sample population. This would help the     investigators evaluate the technical success rates, clinical success rates, feasibility and     safety of PDT for unresectable cholangiocarcinoma. With more endoscopists considering PDT as     a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to     further evaluate the efficacy and safety of such combined procedures as well. The ultimate     objective is to assess if PDT with or without additional or adjuvant treatment options     prolongs survival duration and improves quality of life in patients with unresectable     cholangiocarcinoma.      This multicenter registry has been initiated:        -  To document the impact of PDT on the clinical management of unresectable          cholangiocarcinoma.        -  To assess the clinical and technical success rates of PDT for unresectable          cholangiocarcinoma.   "
134515|NCT01524133|"     The current research study aims to compare the effectiveness of two proven treatments for     posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their     combination. In addition, the investigators are examining predictors of response to these two     treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such     treatments. Biological mechanisms of change are also examined including emotion processing     and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the     investigators will examine acceptability of each treatment and reasons for ending treatment.   "
146033|NCT01372839|"     Compare with regular regimen, the aim of this study is to testify whether having more statin     during PCI will benefit in Chinese population, and to find out optimal dose of the drug for     patient after PCI.   "
134519|NCT01524081|"     Aim of prospective randomized a placebo controlled study is to prove that in case of acute     surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel     and stomach appropriately administered antibiotic prophylaxis is effective with lower     incidence of infection in surgical site and comparable risk of development of other     nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to     determine risk of developing nosocomial infection in the above mentioned group of patients,     identify group of patients which does not benefit from prophylaxis, and compile financial     costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the     background for the recommended procedure with regards that such prospective study does not     exist in the Czech Republic.   "
134520|NCT01524068|"     This is a randomized, multi-center, open-label Phase II clinical trial to determine the     efficacy of combined plasma exchange (PEX), rituximab, and conventional corticosteroid     administration, in comparison to corticosteroids alone, among patients with acute Idiopathic     Pulmonary Fibrosis (IPF) exacerbations.      The investigators central hypothesis is that antibody-mediated autoimmunity can play an     important role in IPF exacerbations. The investigators propose to test our central hypothesis     by establishing the efficacy of autoantibody removal by plasma exchange (PEX), in conjunction     with B-cell depletion by rituximab to deplete immunoglobulins and minimize their further     production, among patients with acute IPF exacerbations.      The primary goal of this randomized, multi-center, open-label Phase II clinical trial is to     determine effects of combined plasma exchange (PEX), rituximab, and conventional     corticosteroid administration on selected, relevant immunological parameters, in comparison     to effects of steroids alone, among AE-IPF patients. The investigators anticipate the     findings of this will lead to larger incremental trial(s) to determine actual clinical     efficacy of this treatment.      A total of 40 subjects will be enrolled in this multi-center trial from 5 participating     medical centers.   "
134521|NCT01524055|"     Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel.     In 2008, a novel balloon-assisted enteroscope system has been developed using only a single     balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and     treatment of the small bowel. The investigators could demonstrate the both endoscopic     procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic     procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the     bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas     insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air,     however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy,     significant amounts of air are usually retained in the bowel segment inspected. This air has     to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and     discomfort during and after the examination due to the retention of air have been shown to be     very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air, is     rapidly absorbed from the bowel. Within minutes, several liters of CO2 can be absorbed from     the GI tract. The use of CO2 has been shown to result in more comfortable examinations in     both colonoscopy and flexible sigmoidoscopy in several randomized trials. In these studies,     CO2 insufflation had almost completely reduced procedure-related pain and discomfort.      In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE.     Another group confirmed our findings. To our knowledge, no study has been performed     investigating the use of CO2 in SBE.      The aim of the present study is to examine whether CO2 insufflation leads to a reduction of     abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2     insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.   "
134522|NCT01524042|"     Recently colonoscopy has gained importance as screening programs for colon polyp, cancer and     inflammatory bowel disease in the United States and other countries. The number of     colonoscopy performed has been increased year by year. To make an increased compliance with     colonoscopy in both screening and clinical surveillance programs, consideration of anxiety,     shame and satisfaction in examinee is regarded to be important. During colonoscopy patients     wear conventional single pants where there is no hole for insertion of scope. Patients take     off the conventional single pants below the buttocks and expose their buttocks and perianal     area during colonoscopy. Exposing perianal and perineal area during colonoscopy can make     patients feel shameful and anxious and diminish satisfaction of colonoscopy. Recently     considering the factors affecting satisfaction has been regarded to be important because     patient satisfaction could be one of the quality indicators for colonoscopy. To diminish     shame and anxiety by exposing perianal and perineal area of patients wearing conventional     single pants during colonoscopy, we developed novel double pants with a hole in inner pants.     Novel double pants are composed of double fabrics from hip to thigh and single fabric under     the thigh such as common pants. In the inner pants of double pants, there is a hole for     insertion of scope. The hole is 25 cm wide and 15 cm long. The outer pants are same as     conventional single pants. If the patients dropped outer pants below hips, only hip and     perianal area are exposed through the hole (25cm*15 cm) for insertion of scope without     dropping inner pants. Therefore novel double pants minimized the exposed area of hips than     conventional single pants because hips are exposed only the hole of inner pants. Smaller     exposed area of hips by novel double pants can minimized the shame and anxiety by diminishing     exposing perianal and perineal area during colonoscopy. Therefore advantage of novel double     pants is decreasing shame and anxiety and increasing satisfaction by minimizing the exposed     area of perianal and perineal area compared with conventional single pants. This study is a     randomized controlled study. The investigators will survey the examinees older than 20 years     who performed the colonoscopy at Severance Hospital from Feb. 2012 to Jul. 2012 to compare     the effect on the satisfaction, shame, and anxiety during colonoscopy between the two groups.   "
134523|NCT01524029|"     The goal of this study is to determine the value of the new mammography technique called     Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital     Mammography for the early detection of Breast Cancer.      DBT is able to compute a three-dimensional image of a breast from several low-dose     mammographies taken from different angles while the device is moving around the breast in a     circular motion. This should overcome a significant limitation of Digital Mammography arising     from the masking of breast cancer in a mammography image caused by overlying normal breast     tissue.      This is a study conducted in several Austrian Breast Imaging Centers.   "
134524|NCT01524016|"     Oncogenic osteomalacia is rare disease predominantly caused by a small, somatostatin receptor     positive mesenchymal tumor, which is frequently hidden in an unusual anatomical site and     often goes undetected by conventional imaging. A permanent cure of the disease relies on     exactly localizing the tumor and completely removing it. 68Ga-DOTATATE PET/CT is a novel scan     that might have improved sensitivity and resolution specifically for somatostatin receptor     positive tumors. The investigators will scan the suspicious and confirmed patients of     oncogenic osteomalacia and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT to see     if it improves patient care.   "
134525|NCT01524003|"     The purpose of this study is to develop and implement a community based preventive healthcare     model using cervical cancer screening as the target medical intervention.      The investigators will first conduct 2 pilot studies to refine their preventive healthcare     model based on the principles of community based participatory research (1000 participants).     The investigators will then apply the model to screen 9000 women for cervical cancer over a     period of 7-9 days. This 10,000 patient trial will explore the ability of a community to     conduct their own screening program to identify who needs medical intervention based on     self-collection and centralized high-throughput low cost human papillomavirus (HPV) testing.   "
134665|NCT01522170|"     There is growing but limited information on the long term clinical status of aHUS patients     who have previously received or are continuing to receive treatment with eculizumab. This     study is designed to collect clinical data that will provide insight into the long-term     outcomes of patients with aHUS.   "
134527|NCT01523977|"     Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent     tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus     is approved for use in the United States for certain types of cancer, such as kidney cancer.     It has been extensively studied in people with various types of cancer as a single agent (a     drug that is used alone to treat the cancer) or in combination with a number of other drugs.     Studies in adults with cancer have also evaluated Everolimus in combination with other     anti-tumor drugs. Information from lab studies and some other clinical trials suggests that     Everolimus may kill leukemia cells on its own, and also make it more likely that steroids     (such as prednisone) are able to kill leukemia cells.      In this research study, we are looking to learn more about how Everolimus works in     combination with other drugs which are commonly used to treat relapsed acute lymphoblastic     leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the     study is to evaluate the side effects of this treatment combination in order to determine a     safe dose of Everolimus which can be given with these other 4 drugs.   "
134528|NCT01523964|"     Physicians seek a method to assess neuromuscular disease that is both non-invasive and     quantifiable. Many patients do not tolerate standard current day assessment tools (such as     needle electromyogram), and Electrical Impedance Myography (EIM) has the potential to serve     as a non-invasive, quantifiable, diagnostic tool for neuromuscular disease. If successful,     these devices will allow for improved ability to diagnose neuromuscular disease and to assess     disease progression or remission, allowing for better care of individual patients as well as     for use in clinical trials, where improved outcome measures for neuromuscular diseases is     being sought.   "
134529|NCT01523951|"     Aim of the study is to demonstrate superiority of a continuous cooling of the skin over     topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8%     patch (Qutenza).      Secondary it will be tested, if the 2 different pre-treatments have an effect on the     application pain within the first 24 hours, and if different pre-treatments have an effect on     the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza application.   "
134530|NCT01523938|"     The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac     or spinal column surgery. A particular aim is to point out the effects on postoperative     cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac     stratum).   "
134531|NCT01523925|"     This project attempts to perform a randomized controlled trial to verify the efficacy and     motor control mechanism of the proposed combined functional electrical therapy with     distributed constraint-induced therapy or with robot-assisted Bilateral training.   "
134532|NCT01523912|"     The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the     follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the     last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment     of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied.     The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment     of dysplastic gastric mucosa.   "
134533|NCT01523899|"     This study expands upon pilot data for feasibility since May 2011. The study aims to evaluate     the effect of rapid test availability on use of targeted spectrum antibiotics for non-MRSA     abscesses in ambulatory patients in the Emergency Department (ED). The multi-institutional     study will assess the feasibility of providing the GeneXpert® MRSA/SA SSTI assay to the ED     and evaluate the impact of delivering the test result to clinicians in real-time on patient     management decisions regarding the use of antimicrobial agents. Patients are randomized to     standard culture (control arm) or to the GeneXpert® assay plus standard culture.   "
134534|NCT01523886|"     The purpose of this investigation is to compare the surgical conditions during laparoscopic     cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.      The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are     better with deep muscle relaxation than moderate muscle relaxation.   "
134535|NCT01523873|"     The main purpose of this study is to prospectively assess the general safety profile of     Dotarem   "
134536|NCT01523860|"     This is a prospective, multicenter phase II trial designed to determine efficacy and safety     of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone     in elderly patients with advanced stage Follicular Lymphoma.   "
134537|NCT01523847|"     The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the     cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is     substituted for doxorubicin in the conventional ABVD regimen.   "
134538|NCT01523834|"     Treatment of adult patients with Diffuse Large B-cell Lymphoma (DLBCL), relapsed or     refractory to previous CHOP-R (or CHOP-R like regimen) front line therapy, relapsed or     refractory to second or subsequent salvage therapies which included high dose therapy with     autologous stem cell support (ASCT).      Treatment of adult patients with DLBCL relapsed or refractory to front line therapy with     CHOP-R (or CHOP-R like regimen) or subsequent treatments, who are not consider eligible for     ASCT consolidation because of age, co-morbidities, impossibility to perform ASCT.      The trial is conducted according to the optimal two-stage design of Simon with alpha 0.05 and     beta 0.10, considering the following two hypotheses: first a response rate (RR) less than 10%     is of no further interest; and second, an RR 30% is clinically meaningful. In the initial     stage, 18 patients have to enter onto the study. If less than 3 responses (</=2 in 18) will     be observed, the trial would be terminated. Otherwise, accrual will continue to a total of a     maximum of 35 patients. At the end of the trial, if 6 or fewer responses will occur among the     35 patients (</= 6 in 35), it will be concluded that the regimen is not worthy of further     investigations for that group of patients.      The treatment is divided in three phases: induction phase (course 1 to 6), consolidation     phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any     reason).   "
134539|NCT01523821|"     This phase I/II trial studies the side effects and best dose of alpha 1 anti-trypsin     (alpha-1-proteinase inhibitor human) and to see how well it works in treating patients with     acute graft-versus-host disease (GVHD). Alpha-1-proteinase inhibitor human may be a better     treatment for graft-versus-host disease caused by a stem cell transplant.   "
146034|NCT01372826|"     This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal     impairment compared to that in subjects with normal renal function.   "
134540|NCT01523808|"     The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo     studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly,     these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA     is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I     clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced     or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy     using gemcitabine.   "
134541|NCT01523795|"     The purpose of this study is to determine whether playing motion-controlled video games     produces low caloric intake and higher caloric expenditure than watching TV or playing     traditional video games.   "
134542|NCT01523782|"     There is not clinical validation that the benefits of L-asparaginase can offers during     induction chemotherapy for elderly patients, where prevent toxicities is critical.This Phase     IIa clinical trial propose to evaluate, specifically for elderly patients, the tolerated dose     of GRASPA® in combination with a poly chemotherapy treatment which enables efficient     L-asparagine depletion for a period at least equal to 7 days.   "
134543|NCT01523769|"     Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these     infants have higher circulating blood volume in the first 24 hours, less need for blood     transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord     clamping has also been shown to increase the initial hematocrit and decrease the need for red     blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33     weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically     interfere with neonatal resuscitation. There have been few studies that addressed the active     milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical     cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds     to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as     an alternative to delayed cord clamping, has been shown to increase the circulatory blood     volume expressed as the hemoglobin value. Active milking of the cord prior to clamping,     however, is not considered standard of care and only 1 Japanese randomized control study has     reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the     number of infants requiring a RBC transfusion as compared with control conditions. Our study     aims to test the hypothesis that active milking of the umbilical cord will reduce the need     for transfusion in preterm infants.   "
134544|NCT01523756|"     This is an open-labelled randomized cross-over and controlled exploratory intervention that     aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy     appliances each for two weeks. During the test a questionaire is to be filled out and     interviews will take place. Primary parameter is leakage. A Study nurse will visit the     participants in their homes every two week during the test.   "
134545|NCT01523743|"     The purpose of this study is to compare compact intermittent catheters with standard coated     intermittent catheters with regard to quality of life, using the Intermittent     Self-Catheterisation Quality of life Measure.   "
134546|NCT01523730|"     Cigarette smoking rates are extremely high in persons with schizophrenia and this increases     the risk of disease and death due to tobacco-related disorders. One of the features of     schizophrenia is reduced cognitive abilities, such as poor attention and memory. It is     thought that people with schizophrenia smoke cigarettes to reduce these cognitive problems,     as nicotine can improve cognitive function in these people. When people with schizophrenia     stop smoking it causes further cognitive difficulties, which makes quitting harder for them     compared to people without schizophrenia. A method called repetitive transcranial magnetic     stimulation (rTMS) allows clinicians to give repeated magnetic pulses through the scalp to     cause changes in brain activity and behaviour. rTMS can improve cognitive function in people     with schizophrenia. Studies have also shown that rTMS can reduce tobacco craving and     consumption of cigarettes. Therefore, we believe that rTMS will improve the cognitive     deficits observed during cigarette smoking abstinence and help reduce cravings for     cigarettes. Ultimately, rTMS may help smokers with schizophrenia who can't quit smoking with     available treatments. This study will examine the effect of rTMS on tobacco cravings and     cognitive problems produced by overnight abstinence from cigarette smoking in persons with     schizophrenia in comparison to people without mental illness who smoke. Important information     about the potential of rTMS for the treatment of cognitive deficits and tobacco addiction in     schizophrenia will be obtained. Providing more effective smoking cessation treatments in     people with schizophrenia may lead to improved physical and mental health for these patients,     who are extremely susceptible to tobacco addiction and tobacco-related illness.   "
134547|NCT01523717|"     The purpose of this study is to investigate the relationship between a procalcitonin decrease     over 72 hours and outcome in patients who have severe sepsis or septic shock.   "
134548|NCT01523704|"     The number of patients with implantable pulse generator (IPG) has steadily increased in Japan     causing increment in number of in office follow-ups and greater burden on many hospitals.      The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home     Monitoring system reduces office follow-up visits without compromising patient safety.      Patients will be randomized into HM follow-up only (Group 1) or HM & in-office follow-up     (Group 2) and will be followed-up for 27 months.   "
134549|NCT01523691|"     Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient     sleep increases susceptibility to a variety of disease states by progressively compromising     the integrity of stress response systems.   "
134571|NCT01523405|"     This is a non-interventional, cross sectional, multicentric study in T2DM patients which will     involve a single visit for study related procedures. This study will be conducted in     approximately 5,000 patients at around 300 hospitals/primary care clinics across India.     Approximately 18-20 patients per site will be enrolled. This study has been designed to     evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in     relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM     patients on oral / injectable anti-diabetic drugs with/without insulin therapy.   "
134572|NCT01523392|"     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African     American patients with stable coronary artery disease.   "
134550|NCT01523678|"     Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly     paclitaxel/carboplatin regimen in gynaecological cancers.      Purpose: This multicenter phase II trial is studying the side effects of weekly     paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent     epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or     cervical carcinoma. Data obtained in this trial will be compared with historical data as     published earlier.      The trial will include 3 cohorts of 36 patients:        -  Subjects with ovarian, fallopian tube or peritoneal carcinoma        -  Subjects with endometrial cancer        -  Subjects with cervical carcinoma      Treatment:      Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously     weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and     possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of     chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2     years and then if clinically indicated. Subjects who develop disease progression will     discontinue therapy. Subjects who have no evidence of disease progression after completion of     study therapy will be followed until disease progression, withdrawal of informed consent, or     death.   "
134551|NCT01523665|"     Glucose metabolism is impaired in many critically ill patients and is often aggravated by     parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion     protocols, which are based on frequent bedside glucose monitoring, have been implemented on     most critical care units. Despite extensive efforts of the intensive care unit staff     difficulties were experienced in achieving efficient and safe glucose control. Several     barriers to the implementation of glycemic control have been identified. Most importantly,     there is concern about increased frequency of severe hypoglycemic episodes. To overcome these     problems Space GlucoseControl was developed as a decision support system which helps to     achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or     4.4 - 8.3 mmol/l).      The objective of this non-interventional study is to gain additional information on the     performance of the Space GlucoseControl system for glycaemic control in ICU patients when     used in routine clinical practice.   "
134552|NCT01523652|"     The purpose of this study is to determine whether HGF serum concentration might be raised in     vivo by administering nadroparin given with prophylactic purpose to gynecological patients.   "
134553|NCT01523639|"     This multicenter randomized, placebo-controlled phase II study will enroll 132 first-line     palliative treated subjects with metastatic KRAS wild type CRC. Subjects with histologically     confirmed, KRAS wild-type CRC without previous chemo-therapy for metastatic disease will be     screened for this study.      Approximately 10 sites in Austria will participate in the study. Subjects will be randomized     in a ratio of 1:1 into two groups.   "
134554|NCT01523626|"     Computed tomography (CT) scanning has become essential in the early diagnostic phase of     trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT     scanners and infrastructural improvements made 'total body' CT scanning (TBCT) technically     feasible and its usage is currently becoming common practice in several trauma centers.      However, literature provides limited evidence whether immediate 'total body' CT scanning     leads to better clinical outcome then conventional radiographic imaging supplemented with     selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the     value of immediate TBCT scanning in trauma patients.      The investigators hypothesize that immediate 'total body' CT scanning during the primary     survey of severely injured trauma patients has positive effects on patient outcome compared     with standard conventional ATLS based radiological imaging supplemented with selective CT     scanning.   "
134555|NCT01523613|"     The purpose of this study is to extend our knowledge concerning the clinical performance of     two dental filling materials in molars. The study will compare two high-strength     glass-ionomer filling materials.      The investigators hypothesize that after two years (1) the clinical performance of both     filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar     or higher incidence of fracture than Fuji IX GP fillings.   "
134556|NCT01523600|"     The purpose of this randomised (double-blind) controlled exercise intervention trial is to     determine whether the whole body vibration (WBV) training can effectively improve physical     functioning of older people living in or regularly using services of sheltered housing,     reduce their fear of falling, and prevent falling. The study comprises a 10-week training     period and a 10-month follow-up period.   "
134557|NCT01523587|"     This randomised, open-label phase III trial will be performed in patients with advanced     squamous cell carcinoma of the lung requiring second-line treatment after receiving     first-line platinum-based chemotherapy. The primary objective of this trial is to compare the     efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.   "
134558|NCT01523574|"     Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part     of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One     of the most important limitations to its use is the induction of both acute and chronic     peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the     incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine     if vitamin E could also prevent Ox-induced acute PN   "
134559|NCT01523561|"     The aim of this study is to evaluate if creative dance twice weekly can influence girls     wellbeing. The focus lies on girls 13-18 years old that suffer from repeatedly psychosomatic     problems and/or stress.      Specific objectives are        -  To assess the effect of the dance intervention in reducing psychosomatic problems (such          as pain in the head, neck, shoulder or stomach), stress and depression        -  Determine which factors are important for continuing dancing and keeping up new habits        -  A cost-effectiveness analyse of the health outcome.      Geographical area: Örebro County (population 276,000)   "
134573|NCT01523379|"     The complex regional pain syndrom is a weighty disease that often results in a lifelong     disability. Mostly this disease appears unilateral after comparatively mundane fractures or     operations. In early stages CRPS shows inflammatory processes. These inflammatory components     can be seen as edema and vasodilatation. These inflammatory processes lead us to the     hypothesis that selective COX-2-inhibitors might help patients with CRPS.   "
134574|NCT01523366|"     The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic     patients with stable coronary artery disease.   "
134560|NCT01523548|"     The purpose of this study is to examine the potential of carbon monoxide (CO) to decrease     elevated blood pressure in the pulmonary artery. This symptom is seen in patients with     pulmonary arterial hypertension, a rare disease that causes fatigue, dizziness, and shortness     of breath because the blood vessels that supply the lungs narrow, forcing the heart to work     harder to push blood through. Previous studies in the laboratory have shown that carbon     monoxide has promise in treating these symptoms.      Subjects in this study are being asked to undergo a new type of treatment to improve     pulmonary arterial hypertension by breathing CO gas. CO is a colorless, tasteless, odorless     gas usually found in car exhaust or cigarette smoke. It is administered with a continuous     flow of air. Subjects will undergo a screening process during which it will be determined if     they are eligible for the study. After the screening process, if subjects meet eligibility     criteria for the study, they will begin carbon monoxide treatment through a cushioned mask     that is placed over the nose and mouth. This treatment will last for sixteen weeks.   "
134561|NCT01523535|"     The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to     stay. Americans are working more and more, frequently at multiple jobs. The pattern of short     sleep during the week followed by attempts to recover on the weekend is in common practice,     but we know little of the associated health risks. What is the cost in terms of increasing     known risk markers for cardiovascular disease, of repeated nights of insufficient sleep, and     is this cost compounded with repetition, without adequate recovery? Evidence is accumulating     to suggest that short sleep duration is linked to the development of metabolic and     inflammation-associated diseases, such as cardiovascular disease. Mechanisms involved in the     development of cardiovascular disease include impaired vascular function and inflammation.     The current proposal is designed to investigate the effects of repeated periods of short     nocturnal sleep duration in 4 cycles (each cycle consisting of 3 nights of 4 hours of sleep     opportunity per night), and each cycle of short sleep followed by a single night of recovery     sleep. Vascular reactivity will be assessed using brachial artery flow mediated dilation, and     microcirculatory vasodilation will be assessed using perfusion imaging techniques. The     dependence of IL-6 and sVCAM-1 as measured in peripheral circulation, on vascular function,     will also be investigated.   "
134562|NCT01523522|"     This project aims to offer autologous muscle-derived progenitor cell injection as an     efficient mini-invasive surgical therapy that would be simple for the patient and could be     used in a majority of cases, including in young women in the post-partum. This approach may     provide efficient tissue repair of the striated anal sphincter which is not permitted by     existing therapies. This innovative therapy may ultimately be proposed after failure of the     common treatments and before an high-risk invasive surgical intervention. Besides, injection     of muscle-derived progenitor cells in animals has shown very encouraging results of the     sphincter function assessed ex vivo. Hence, a high benefit may be expected with this     approach.   "
134563|NCT01523509|"     The proposed test is intended to enable dentists to differentiate between cavitated and     non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).     In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays     (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low     sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,     pain, root canals, and possible later loss of teeth.      Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of     early cavitation from 58% to 90%.   "
134564|NCT01523496|"     The purpose of this study is to determine the correct dose of Vitamin D to give to prevent     HIV related complications.   "
134565|NCT01523483|"     The investigators study objective is to investigate the effectiveness of vaginal micronized     progesterone in prolonging pregnancy after an episode of preterm labor which responded to     tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions     of progesterone supplementation by examining its effect on the two components of parturition:     cervical ripening and myometrial contractility. The investigators will utilize transvaginal     ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal     uterine EMG to assess the uterine muscle activity. The investigators will also look at the     effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is     expected to provide much more information.   "
134566|NCT01523470|"     The investigators design a pilot randomised, single-centred, controlled trial to compare     different withdrawal methods of Non-invasive ventilation. Our study aims at comparing     stepwise withdrawal of Non-invasive ventilation versus immediate withdrawal of Non-invasive     ventilation. The primary endpoint is to compare the rate of success between two withdrawal     methods. The investigators define success as no recurrence of acute hypercapnic respiratory     failure or restitution of Non-invasive ventilation within 48 hours after NIV is stopped. The     secondary endpoints include time to recurrence of acute hypercapnic respiratory failure     measured from the time of randomisation, the total days of Non-invasive ventilation use and     the days of hospitalisation. Results from this trial will inform design of future randomised     trial in this area.   "
134567|NCT01523457|"     The primary objective of this study was to determine the progression free survival in     patients with metastatic pancreatic cancer and in patients with locally advanced unresectable     non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid,     fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints included:     determine objective response rate according to RECIST; determine overall survival; evaluate     toxicity; determine rate of resection in locally advanced unresectable stratum; correlate     time to progression, objective response, and overall survival with early changes in glucose     metabolism using [18F]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.   "
134568|NCT01523444|"     This proposed study tests the effectiveness and examines the implementation of screening and     brief intervention techniques to delay initiation and reduce substance use among adolescents     accessing medical care in Federally Qualified Health Care settings with a     computer-facilitated intervention. The primary hypothesis is that participants in the     intervention groups will be more likely to cease or reduce substance use at follow-up     compared to clients in the treatment as usual condition.   "
134569|NCT01523431|"     The purpose of this study is to investigate the influence of dose selection of CPT-11 on     toxicity, response and pharmacokinetics according to UGT1A1 genotype in colorectal cancer     patients.   "
134575|NCT01523353|"     Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to     the liver. This is major surgery that offers a chance of cure, but can be associated with     complications. Fitter patients are less likely to have serious complications. We are     interested in finding out whether a short exercise program can improve patient fitness before     surgery and whether this can reduce surgical complications.      We plan to measure the fitness of patients who are going to have liver surgery. We will then     give them an exercise programme for 4 weeks, after which we will assess their fitness again.      We are also interested in whether fitter people have better Liver function. To assess this we     will take a small sample of liver tissue during the operation for laboratory analysis of its     function.      Hypothesis        1. A short period of exercise can significantly improve fitness prior to liver surgery        2. Greater Fitness is associated with better liver function.   "
134576|NCT01523340|"     1. Trial design: Prospective observational study        2. Target population: 200 NSCLC patients with histologically or cytologically confirmed          stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who          consent for study participation and meet the study selection criteria        3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations          in NSCLC patients treated with Erlotinib             -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR        4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome          (Overall Response Rate, Progression Free survival )        5. Duration of Trial Recruitment: 2 years   "
134577|NCT01523327|"     Association of maternal uric acid with maternal condition and fetal outcome in pregnant women     with hypertension.   "
134578|NCT01523314|"     The research group has developed new ocular drug delivery technology based on cyclodextrin     nanoparticles (NP). The investigators plan to develop and test this technology to help treat     diabetic macular edema (DME).      An important step in research was the invention of cyclodextrin nanoparticles, which has just     received a US patent. The investigators pre-clinical and clinical work has demonstrated the     investigators eye drop suspension with cyclodextrin nano-particles to be superior to     conventional eye drops. They increase drug absorbance into the eye and decrease systematic     distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops     deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in     ocular pharmacology.   "
134579|NCT01523301|"     The purpose of this study was to show superiority of Rotigotine over placebo on improvement     of depressive symptoms in subjects with idiopathic Parkinson's disease.   "
134580|NCT01523288|"     The projects aim is to investigate the intestinal function of patients suffering from     Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal     diameter and gastrointestinal transit time   "
134581|NCT01523275|"     This is a randomized, prospective, double-blind, placebo-controlled clinical trial of the use     of mitomycin-C topical application as an adjunctive treatment in the endoscopic surgical     treatment of patients with laryngotracheal stenosis. We hypothesize that the use of     mitomycin-C improves patient outcome in the endoscopic surgical treatment of laryngotracheal     stenosis.   "
134582|NCT01523262|"     Primary To investigate whether peripheral predonditioning induced by brief, intermittent     constriction of blood supply to an arm can reduce the incidence of perioperative myocardial     ischemia in patients operated electively for infrarenal aortic aneurysm.      Secondary To investigate the impact of peripheral preconditioning on perioperative     inflammatory response.      To investigate whether peripheral preconditoning can protect against perioperative myocardial     infarction and reduced cardiac pump function.   "
134583|NCT01523249|"     The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D     US) technique with the traditional palpation method for identification of the needle     insertion site on patients' skin before epidural needle placement in pregnant women. The     investigators hypothesize that the needle puncture site identified by 3D US is located within     a 5 mm radius from the puncture site identified by palpation.   "
134584|NCT01523236|"     The objective of this study is to evaluate the clinical equivalence of the test formulation     of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva     Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed     formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation     (Schering) in patients with seasonal allergic rhinitis.      In addition, the efficacy of both the test and reference nasal sprays will be compared to a     placebo nasal spray and safety will be compared.   "
134585|NCT01523210|"     Intramuscular application of botulinum toxin (BoNT) is used as a successful therapy of muscle     spasticity. Clinical practice shows, that even with the use of special guidance techniques to     increase accuracy of targeting, BoNT may spread to adjacent sites by diffusion. This causes     fluctuating treatment response, unintended side effects, and decrease of effect due to     production of antibodies. Hence, clinicians require increase of efficacy and safety by dose     reduction, improvement of injection technique, and additional treatment strategies. Referring     to this, animal model showed increased efficacy and decreased systemic side effects of BoNT     in the injected muscle after active or passive manipulation of muscle. The mechanism of this     effect remain unclear.      T2 and (Diffusion Tensor Imaging) DTI technique can evaluate the in-vivo distribution of     fluids in human skeletal muscle. In addition, it allows to differentiate denervated muscle     tissue, caused by BoNT injections, from surrounding unaffected muscle tissue.      Up to the investigators knowledge, neither a human, in vivo measurement of the influence of     passive muscle activity on the area of denervation, nor the primary, in-vivo distribution of     BoNT within spastic human muscle tissue, been evaluated.      The aim of this explorative study is:        -  to monitor the inflow and regional distribution of the injection bolus by dynamic          T2-weighted-, DTI-sequences;        -  to assess the effect of passive muscle exercise on the area of denervated, caused by          BoNT, measured by DTI-, T2-weighted and flair sequences.      The investigators hypothesize, that        -  intramuscular denervation area, measured by DTI-, T2-weighted and Fluid Attenuated          Inversion Recovery (FLAIR) sequences, 3 weeks after routine BoNT injection, is          facilitated by passive muscle exercise;        -  primary distribution of the injected BoNT bolus can be non-invasively monitored by          dynamic T2-, DTI- and T2 weighted sequences.      Therefore, in this investigator blinded, cross-over study, 6 patients suffering from upper     limb spasticity, including musculus biceps brachii, will be investigated. (Magnetic Resonance     Tomography) MRI of the musculus biceps brachii will be performed at two consecutive, routine     BoNT-injection days (baseline and week 16). Patients receive dosage as clinically indicated,     due to routine treatment. Patients will be randomised to receive thirty minutes of     physiotherapy of the affected arm, including exercise of the elbow flexors, at one of the     injection days (baseline, or week 16, respectively). In addition, MRI will be repeated 3     weeks after injection.   "
134646|NCT01522417|"     The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a     shortened infusion duration compared to label-dosing eptifibatide in patients undergoing     percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of     death, PCI-related myocardial infarction, urgent target vessel revascularization or     in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever     comes first.   "
134586|NCT01523197|"     Obstructive Sleep Apnea Syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) are     two diseases that often coexist and are called overlap syndrome(OS). Compared to single OSAS,     OS patients are more susceptible to serious hypoxia and hypercapnia especially during sleep,     and are much more likely to result in pulmonary hypertension and cor-pulmonal.      With a more flexible expiratory positive airway pressure (EPAP), auto-trilevel ventilation     may be superior to fixed bilevel positive airway pressure (BiPAP) ventilation in both     removing residual obstructive sleep apnea hypopnea events and correcting hypercapnia     simultaneously. The overall purpose of this study is to compare the curative effects between     fixed BiPAP and auto-trilevel ventilations on OS patients.   "
134587|NCT01523184|"     This will be a single-center, randomized, parallel group, multiple dose administration,     double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small     bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation.     Four groups including a placebo group will be enrolled and will receive multiple oral doses     of YKP10811 or matching placebo.   "
134588|NCT01523171|"     Primary Objective:      - To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated     with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2     or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF),     or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen     volume at the end of 6 treatment cycles;      Secondary Objectives:        -  To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary        -  To evaluate the durability of splenic response        -  To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6        -  To evaluate the splenic response to SAR302503 at the end of Cycle 3        -  To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden        -  To evaluate the safety and tolerability of SAR302503 in this population        -  To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted   "
134589|NCT01523158|"     Hay fever (seasonal allergic rhinitis) results from allergy to grass and tree pollen. The     majority of affected individuals manage well with medication from the Pharmacy or from their     general practitioner (GP), but for some severely affected people it severely impacts on     quality of life. Less than 40% of those affected in UK general practice feel that these     medications achieve good symptomatic control.      Specific immunotherapy or desensitisation is the practice of administering small amounts of     allergen to allergic patients in increasing doses. This treatment is highly effective in     these patients and furthermore is truly disease-modifying, with benefits persisting     long-term, even when the treatment has been completed. Desensitisation is a routine treatment     in the UK, Europe and North America. The exact immune mechanisms that underlie this     symptomatic improvement are not entirely clear. Dr Tarzi, Professor Frew and Professor Kern     have recently developed new methods for the investigation of immune responses to allergens.     These methods require relatively small blood samples and may provide useful information about     how immunotherapy exerts its effects. In addition to improving the investigators basic     understanding of this treatment, such knowledge may drive improvements in the treatment and     could be useful for monitoring patients for response. The investigators study proposes to     investigate changes in the immune responses to pollen allergens during immunotherapy. Blood     will be taken just prior to the first immunotherapy injection and again just prior to the     final injection. In this way the investigators will be able to compare the immune responses     to pollen allergen before and after treatment.   "
134590|NCT01523145|"     Atrial fibrillation is the most common arrhythmia and affect 1-2 % of the population in the     western world. Atrial fibrillation can be treated with a relatively new procedure, called     radiofrequency ablation.      The aim of this study is to explore if patients treated with ablation for atrial     fibrillation, benefit from an integrated rehabilitation programme, that consist of physical     training and psycho-educative consultations with a specialised nurse.      The hypothesis is, that integrated rehabilitation can improve mental health, physical     capacity and other factors.   "
134591|NCT01523132|"     The study is a prospective cohort study following breast cancer patients from before surgery     to one year after. The aims of the study are to determine risk factors that predispose to the     development of persistent pain.   "
134592|NCT01523119|"     The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8     mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy     Pharmaceuticals, USA) with Zofran ODT® 8 mg orally disintegrating tablets of Cardinal health,     UK for GlaxoSmithKline, USA in healthy, adult, human, male subjects under fed condition.   "
134593|NCT01523106|"     This is a randomized, double-blind, placebo-controlled study, comparing the effect of     L-carnitine vs placebo on fatigue among Crohn's disease patients.      The specific aim of this study is to determine if treatment with L-carnitine is more     effective than placebo at decreasing fatigue severity scores, while accounting for disease     activity and concomitant anemia, depression/anxiety and poor sleep quality.   "
134594|NCT01523093|"     The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8     mg orally disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy     Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg orally disintegrating tablets of     GlaxoSmithKline, USA in healthy, adult, human, male subjects under fasting condition.   "
134595|NCT01523080|"     The study was to compare single-dose oral bioavailability of acetaminophen 650 mg extended     release geltabs (containing acetaminophen 650 mg) of OHM Laboratories Inc. (subsidiary of     Ranbaxy Pharmaceuticals Inc., USA) with Tylenol 8 hour extended release gel tabs (containing     acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals, U.S.A in healthy,     adult, male human subjects under fasting condition.   "
134605|NCT01522950|"     This is a randomized, double-blind, placebo-controlled study comparing the efficacy of     nebivolol and atenolol at improving small artery elasticity and reducing cardiovascular     disease risk in subjects with early vascular disease. Approximately 75 subjects with     borderline/elevated blood pressures and impaired endothelial function, as measured by     arterial elasticity scores, will be recruited and assigned to treatment groups using a block     randomization scheme. Patients will be randomly allocated to nebivolol, atenolol or placebo,     and then followed for 9 months.   "
134596|NCT01523067|"     The primary objective of the study is to evaluate the safety and tolerability of single     ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage     1 or Stage 2 essential hypertension.      The secondary objectives of the study are to characterize the pharmacokinetic profile of     single ascending doses of Vasomera and the relationship between serum concentrations of     Vasomera and change in systolic and diastolic blood pressure as measured by:        -  Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by          ambulatory blood pressure monitoring (ABPM) as compared to placebo.        -  Identification of the minimum and maximum decrease in systolic and diastolic blood          pressure as measured by ABPM.        -  Mean change from baseline in cuff systolic and diastolic blood pressure as compared to          placebo.        -  Effect of Vasomera on pulse pressure and heart rate.      An additional secondary objective of this study will be to characterize the immunogenicity     profile of Vasomera following a single subcutaneous dose.   "
134597|NCT01523054|"     The objective of the study was to compare treatment with two different oral formulations of     metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in     patients with acute myocardial infarction regarding the following:      Pharmacokinetics, peak and trough plasma concentrations and area under the plasma     concentration curve.      Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open,     randomised design with two parallel groups was employed.   "
134598|NCT01523041|"     This trial is conducted in Europe. The aim of this trial is to compare two formulations of     biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart     50 and biphasic insulin aspart 70 in healthy male subjects.   "
134599|NCT01523028|"     Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more     important, hence underlying the importance of better understanding the fate of these     potential health promoting antioxidants. However, some analytical barriers as well as some     key aspects of metabolism still remain to be fully elucidated to get the full picture of     coffee metabolism and bioavailability. One aspect addressed in the present study is the     impact of food matrix in modulating absorption, plasma appearance and urinary excretion of     coffee bioactives.   "
134600|NCT01523015|"     The high cancer related mortality has remained a significant issue of health care in Poland,     Europe and worldwide. The decreasing incidence rate for carcinoma of the distal stomach and a     marked trend of increasing incidence for adenocarcinoma of the esophago-gastric junction and     esophagus has been observed in the developed countries. The most eminent drawback of majority     commonly cited randomized trials is heterogenicity of cancer patient population. The     epidemiological, pathological, and clinical data clearly suggest that adenocarcinoma of the     esophago-gastric junction is the entirety different both from adenocarcinoma of the esophagus     and adenocarcinoma of the stomach. The experience in a combined modality therapy for     adenocarcinoma of the esophago-gastric junction have been extrapolated from studies on     esophageal or gastric cancer, where the investigated population involved in part patients     with carcinoma of the esophago-gastric junction. The proposed study has been designed to     achieve the following objectives:        -  The assessment of safety and efficacy of a combined modality therapy in homogenous          patient population with adenocarcinoma of the esophago-gastric junction excluding          individuals with adenocarcinoma of the esophagus or the stomach;        -  The assessment of safety of a combined modality therapy in a form of chemo- and          chemoradiotherapy related toxicity and impact of chemo- and chemoradiotherapy on          postoperative morbidity or mortality rates;        -  The assessment of efficacy of a combined modality therapy in a form of rate of response          of the tumor to chemo- and chemoradiotherapy and a curative resection rate.        -  The assessment of efficacy of a combined modality therapy in a form of cancer free          survival and overall survival.   "
134601|NCT01523002|"     Pyronaridine: artesunate (Pyramax) is an antimalarial fixed-dose combination therapy which     has been demonstrated to be well tolerated and effective treatment in patients with     Plasmodium falciparum and vivax malaria.      This open-label Phase I study has two parts: a drug-drug interaction part intended to     investigate the interaction of Pyramax in the pharmacokinetics of the CYP2D6 probe metoprolol     and a re-dosing evaluation part intended to investigate the differences on the changes in     liver enzymes induced by Pyramax in a first and in a second treatment course and the effect     of the redosing interval on the changes in liver enzymes induced by Pyramax in a first and in     a second treatment course.   "
134602|NCT01522989|"     This study is for patients with advanced solid tumor malignancies (cancer that has spread to     other parts of the body).      The purpose of this study is to test the safety and effectiveness of a new combination of     drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor     malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called     cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this     enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil     and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus     decreasing the tumors in the body.      PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been     approved by the Food and Drug Administration for use in colorectal cancer. It is given as a     pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and     Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved     for and used as chemotherapy for several cancers.   "
134603|NCT01522976|"     This randomized phase II/III trial studies how well azacitidine works with or without     lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or     chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in     different ways to stop the growth of cancer cells, either by killing the cells, stopping them     from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of cancer     cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine     is more effective with or without lenalidomide or vorinostat in treating myelodysplastic     syndromes or chronic myelomonocytic leukemia.   "
134604|NCT01522963|"     The purpose of this study is to determine the timeframe (relative to a stress task) that is     most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that     occur when smokers are presented with stressful situations.   "
134607|NCT01522924|"     This study determines if there is a difference in dental students' attitudes, perceived     barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation     treatment, and cessation knowledge in those students receiving a tobacco cessation lecture     along with practice sessions using standardized patients and those students receiving only a     tobacco cessation lecture. The study determines if dental students' use of tobacco affects     their intent to provide cessation treatment to patients, and if the time between receiving     the lecture and participating in the practice sessions using standardized patients makes a     difference in dental students' attitudes, perceived barriers, subjective norms. perceived     skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.   "
134608|NCT01522911|"     To date there are no data suggesting substantial effects of hormonal interaction after     percutaneous closure of the left atrial appendage (LAA). Our hypothesis is that by excluding     the LAA from blood flow physiologic stimuli for ANP and BNP produce may be impaired and     consecutive release of the hormones may be reduced. Here, we present our experience of ANP     and BNP secretion in the early postprocedural period after transcatheter closure of the LAA.   "
134609|NCT01522898|"     Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also     suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle     (lower pumping chamber of the heart). In the past decade, CRT has become an established     treatment for heart failure patients who are in normal rhythm, called sinus rhythm. An     important subset of heart failure patients are those with atrial fibrillation (AF), who make     up around 1 in 4 HF patients, and are over-represented amongst HF patients with more advanced     symptoms. In heart failure patients with AF, CRT has proven not to be as effective as in     sinus rhythm, due to competition between beats generated by the CRT device and beats     conducted from the heart's own electrical conduction system. In the current study, we aim to     test the hypothesis that ablating the AV node, which controls electrical conduction from the     heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and     heart failure symptoms in CRT patients with co-existent AF. The results are important,     because they will provide a way of passing on the benefits of CRT, such as improved survival,     less heart failure symptoms, and better quality of life, to heart failure patients who also     suffer from AF.   "
134610|NCT01522885|"     The purpose of this study is to investigate whether if KatGuide (a new developed medical     device) improves the placing of a large bore chest tube in the pleural cavity compared to the     conventional method.   "
134611|NCT01522872|"     This phase 2 study is designed to evaluate the safety and tolerability activity of TH-302 and     dexamethasone with or without bortezomib or pomalidomide in subjects with relapsed/refractory     multiple myeloma.   "
134612|NCT01522859|"     The the aim of this study is to determine the benefits of Telehealth monitoring in the     management of patients with chronic obstructive pulmonary disease.   "
134613|NCT01522846|"     Heparinized solution has been used for maintenance of arterial catheter during perioperative     period. Although the infused dose of heparin is very low, the investigators examine whether     the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM)     analysis.   "
134614|NCT01522833|"     With roughly 80% of cancer patients receiving their oncology care in the community setting,     the investigators are proposing to sample from a community-based center to evaluate the     percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit     from erlotinib and assess the clinical characteristics that are associated with     erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are     EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.   "
134615|NCT01522820|"     This phase I trial studies the side effects and best schedule of vaccine therapy with or     without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid     tumors. Biological therapies, such as sirolimus, may stimulate the immune system in different     ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed     with tumor proteins may help the body build an effective immune response to kill tumor cells     that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause a stronger     immune response and kill more tumor cells. It is not yet known whether vaccine therapy works     better when given with or without sirolimus in treating solid tumors.   "
134616|NCT01522807|"     The purpose of the study is to evaluate the plasma drug concentrations of three formulations     of PF-05190457 after administration of single doses to healthy volunteers.   "
134617|NCT01522794|"     The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on     iron homeostasis during systemic inflammation induced by endotoxin.      In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an     inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa,     with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron     concentrations decrease.      This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin     and to prevent serum iron decrease in a pathophysiological model prior to studying the     efficacy of NOX-H94 in patients with anemia of chronic disease.   "
134618|NCT01522781|"     The purpose of this study is to obtain a prospective database which will allow analysis of     total knee outcomes.   "
134619|NCT01522768|"     The purpose of this study is to find out what effects, good or bad, the combination of     standard chemotherapy agent paclitaxel with the investigational (experimental) drug afatinib     that targets HER2, has on HER2-positive esophagogastric cancer that started to get bigger     despite previous treatment with trastuzumab. The doctors will also study the tumor to     understand why it grew while on trastuzumab treatment and to see the effects afatinib and     paclitaxel has on the tumor.   "
134662|NCT01522209|"     The study compares the established imaging techniques (CT, MRT, Contrast Ultrasound) with the     new method of intraoperative contrast enhanced ultrasound to compare all methods for their     rate of detection of colorectal liver metastasis.   "
134663|NCT01522196|"     The purpose of this study is to determine the effectiveness of A 001 infusion in preventing     acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis, fever,     and elevated serum C-reactive protein (CRP).   "
134664|NCT01522183|"     Post-marketing safety data on patients treated and untreated with eculizumab.   "
134620|NCT01522755|"     Pacing leads are key elements of a pacing system as their proper functioning is one of the     major factors affecting the long term performance of the whole system.      Success of a pacing lead implant can be defined considering 3 items: ease of lead implant,     lead stability and lead electrical performances.      These factors may be related to the physician experience (global implant experience,     experience with a given lead), to the implant procedure (lead access, lead position, implant     time, scopy time) to the lead (handling and mechanical characteristics) and to the patient     (ischemic history).      Even though implant success rate is quite high with currently available leads, the weight of     the different factors influencing success has never been studied systematically. The     objective of the current study is then to define the predictive factors of an implant success     with the CapsureFix MRI model 5086.      This lead has been selected because it has been available for a short period, so the     investigators have a limited experience of it and it has a unique design which makes it     conditionally safe in an MRI environment and which may be associated with specific handling     characteristics.   "
134621|NCT01522742|"     The main aims of this study are to determine whether: a) psoriasis patients with or without     arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of     etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by     their treating clinicians) will decrease cardiovascular inflammation.   "
134622|NCT01522729|"     Recently, direct evidences point to the contributing role of peripheral muscle fatigue in     exercise tolerance among patients with COPD. However, the physiological mechanisms by which     peripheral muscle fatigue impairs exercise tolerance are still unknown, as factors regulating     peripheral muscle fatigue in COPD may be complex. One possible link between limb muscle     fatigue and exercise intolerance could be enhanced afferent signals from the active limb     muscles to the central command, thereby limiting central motor output and eventually leading     to exercise termination.      A direct method to investigate the regulation of peripheral muscle fatigue during exercise in     patients with COPD is the blockade of peripheral neural afferents via lumbar anesthesia.     Consequently, investigating the interplay between the peripheral muscular component and the     central motor command during self-paced exercise could shed light on the regulation of     peripheral muscle fatigue in COPD and its implication in exercise intolerance.   "
134623|NCT01522716|"     The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as     treatment for steroid-refractory chronic graft-versus-host disease.   "
134624|NCT01522703|"     The primary objective of this study is to determine if broccoli sprouts (BS) improves airway     inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen     sensitization.      The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in     40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be     randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a     sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.   "
134625|NCT01522690|"     The objective of this study is to obtain normative accelerometry data during the six minute     walk test and a 30 second walk test on healthy subjects in order to determine the     accelerometric variables that are the most relevant to describe gait disorders in patient     populations. Secondary objectives of this study are to investigate the impact of walking     speed and muscle strength on the accelerometric parameters, to assess the reproducibility of     the method and to compare accelerometric data obtained with two different devices.   "
134626|NCT01522677|"     The central hypothesis for this study is that it is safe and feasible to administer     intraluminal photodynamic therapy (PDT) to colon cancers by colonoscopy to induce localized     inflammatory/immune response. The objective is to demonstrate the feasibility and safety of     PDT to colon cancer patients administered before surgery and to characterize the     inflammatory/immune response at the tumor site and systemically. The long-term objective of     these studies is to modify he natural biology of colorectal cancers and improve patient     survival.   "
134627|NCT01522664|"     This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A     in patients with metastatic or unresectable melanoma. Cohorts of patients will receive     escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the     absence of disease progression or unacceptable toxicity, patients may continue to receive     DEDN6552A for up to 17 cycles (1 year).   "
134628|NCT01522651|"     The purpose of this study is to evaluate whether treatment with ranolazine or low dose     dronedarone reduces atrial fibrillation burden (AFB) in subjects with paroxysmal atrial     fibrillation (PAF), and whether combination therapy (ranolazine and low dose dronedarone) is     superior to individual drug therapy in reducing AFB.      This phase 2 clinical trial will be conducted over 16 weeks and involves a Screening period     (4 weeks) and a Treatment period (12 weeks). The final follow up visit will occur 2 weeks     after the end of the Treatment period. Primary and Secondary endpoints will be evaluated     according to treatment group, clinic visit period, and the overall Treatment period. Safety     analyses will be conducted at each clinic visit, and include: cardiac rhythm monitoring, ECG     testing, laboratory evaluation, and symptom and adverse event assessment.   "
134629|NCT01522638|"     The purpose of this study is to determine the anatomy of the retina and the optic nerve in     patients with autosomal dominant optic atrophy (ADOA). Based on these findings the aim of the     study is to determine why patients with the same type of genetic material, i.e. the same     mutation, have such large variations of symptoms, spanning from unaffected subjects to     blindness. The project requires examination of both healthy and affected family members.   "
134630|NCT01522625|"     This study aims to clarify whether patients with chronic hepatitis B with high viral load     will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.   "
134631|NCT01522612|"     OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of     cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced     colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil     alone.   "
134632|NCT01522599|"     The main objective of this randomized multicenter clinical trial is to test the hypothesis     that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as     compared to the conventional ARDS-Net ventilation. Control of PaCO2 in the ~4 ml/kg arm     would be accomplished by LFPPV- ECCO2-R.   "
134634|NCT01522573|"     The purpose of this registry is to record information and evaluate the impact of Endoscopic     Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the     management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and     technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde     cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided     ERCP procedures have been assessed in a series of studies.      This multi-center registry has been initiated:        -  To document the impact of EUS-Guided ERCP procedures on the management of          pancreatico-biliary disorders including malignancies.        -  To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or          therapeutic procedures.      Design is retrospective and prospective registry study.      Procedures that will be captured include:        1. EUS-Coils placement        2. EUS Glue injection        3. EUS-Fiducial placement        4. EUS-Neurolysis        5. EUS-Stent placement        6. EUS-alcohol injection        7. EUS-fluid collection, abscess or cavity drainage        8. EUS guided ductal drainage        9. EUS-guided Ablation       10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary          duct drainage   "
134635|NCT01522560|"     Professionalism is one of the six competences required by The Accreditation for Graduate     Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia     residents are faced with unique communication challenges in their practice including brief     contact time with their patients, operating room efficiency pressure, etc. To assess     professionalism in Anesthesiology residents is important to obtain evaluations from people     with whom they interact including patients, surgeons, colleagues and members of the support     team. The Multisource feedback (MSF) approach has been used to evaluate communication skills     and professionalism among practicing physicians and residents in a variety of settings. This     evaluation model has never been used previously to evaluate anesthesia residents. The     investigators propose a randomized controlled trial to validate and evaluate a MSF in     professionalism for anesthesia residents. Participants include eighty residents doing two     months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia     Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using     face and content validity methods and comparing them with the current system of evaluation.     Residents will be randomly assigned to a feedback group or to the control group. Both groups     will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group     assigned to feedback is going to have a 'coaching meeting' every month to identify strengths     and weaknesses and create strategies for improvement. The investigators are planning to     compare the mean values of the baseline evaluations with the mean values obtained after the     first and second months from the MSF.   "
134636|NCT01522547|"     The purpose of the study is to determine the maximum tolerated dose, safety and effect on     induction of fetal hemoglobin of pomalidomide in patients with Sickle Cell Disease.   "
134637|NCT01522534|"     The purpose of the study is to determine the efficacity of a simple blind technic of loco     regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine     : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the     prehospital setting and mountain rescue.   "
134638|NCT01522521|"     The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese     patients with primary osteoporosis.   "
134639|NCT01522508|"     The aim of this prospective randomized study was to evaluate the ability of the new Analgesia     Nociception Index ANI, derived by heart rate variability, to detect painful stimulation     during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.   "
134640|NCT01522495|"     Little is known about chronic wound microenvironments, especially in peripheral vascular     disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells     and tissue is unclear. A means to determine cell viability, particularly discerning an     apoptotic or necrotic cell pathway would indicate where the line of demarcation should be     drawn. The information generated would better predict clinical outcome using SPY Imaging.     Cellular studies are needed to successfully confirm a clear line of demarcation to eliminate     surgeon subjectivity.   "
134641|NCT01522482|"     Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK.     Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying     particles), in particular low density lipoproteins (LDL) in circulation, is one of the most     important physiological defects contributing to the development of CVD.      The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE     genotype, with E4 individuals (25% of the UK population) being most responsive to changes in     dietary fats, showing greater reductions when low levels of saturated fats or fish oils are     consumed and greater increases when high levels of these fats are consumed. Therefore the     aims of the present study is to understand the mechanism that regulates the higher LDLC     response associated with saturated fatty acids and fish oil consumption in healthy men     prospectively recruited based on their APOE genotype.   "
134642|NCT01522469|"     This is a Phase II open label study of crenolanib besylate. This study will enroll subjects     with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other     FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses daily     (preferably every eight hours), taken orally at least 30 minutes pre or post meal until     disease progression, death, or the patient discontinues treatment for adverse events,     investigator's judgment, or other reasons. Patients who are able to proceed to allogeneic     stem cell transplant will be able to resume crenolanib therapy post-transplant in an attempt     to maintain remission.   "
134643|NCT01522456|"     To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to     Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3     weeks in terms of local tolerability parameters (erythema, dryness, scaling,     stinging/burning) and preference.   "
134644|NCT01522443|"     Bone metastases and associated pain are a major cause of morbidity and mortality in     castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability     to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated     by lack of resolution of lesions on bone scan with these agents) or the pain associated with     these metastases.      This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on     pain response and bone scan response in men with CRPC.   "
134647|NCT01522404|"     The purpose of this study is to find out if atomoxetine causes a change in the biologic     markers (substances that may indicate the presence of a disease) in the cerebrospinal fluid     (CSF) of participants diagnosed with Mild Cognitive Impairment (MCI). In this research study,     the spinal fluid of subjects with MCI who take atomoxetine will be compared to spinal fluid     of those who take capsules containing inactive material, also known as placebo. At the     six-month timepoint, subjects who were taking placebo during the first six months will be     placed on active study medication, and those who received active study medication will be     reassigned to placebo. After completion of the study, subjects will be able to receive     open-label atomoxetine.      This study will also evaluate if the drug is safe and well-tolerated. Additionally,     information will be gathered to identify the dose of atomoxetine that is most beneficial, and     how taking this medication affects thinking and behavior, as well as imaging and blood     biomarkers. The results of this research will help determine if atomoxetine alters signs of     inflammation and other biomarkers associated with Alzheimer's disease.   "
134648|NCT01522391|"     The primary objective of this study was to evaluate microbial density in eczematous lesions     during two weeks of twice daily therapy with the investigational product, DPK-060 1%     ointment, compared with placebo in patients with atopic dermatitis. This randomized,     double-blind, placebo-controlled part of the study was preceded with an open-label     investigation in a small group of patients (n=5) treated with two applications of DPK-060 1%     ointment per day for four days to assess safety, local tolerability and systemic absorption     of DPK-060.      The secondary objectives were to evaluate severity of eczema and pruritus, to assess the     tolerability and safety of the treatment and to assess the degree of systemic absorption of     DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.   "
134649|NCT01522378|"     Subjects were recruited if their healthcare provider decided that they needed treatment with     a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators     did this study to see if part of the nerve organ, called the sympathetic nervous system, may     be responsible for the improvement seen in patients that receive biventricular pacing. The     investigators had three ways to measure sympathetic nervous activity: 1) by using a special     blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.   "
134650|NCT01522365|"     This study has been designed in order to collect data with regards to the peri-implant tissue     outcome of abutment-supported restoration and direct implant-fixed restoration. Therefore a     small group of subjects with partly edentulous maxilla is selected to show that both     techniques are efficient and safe and to show comparable peri-implant tissue outcome for both     methods. At the time of impression forming for each centre treatment A (= abutment-supported     XiVE® CAD/CAM supra-structure) and B (= direct implant-fixed XiVE® CAD/CAM supra-structure)     is assigned to the left and right side of the maxilla by being randomized at the time of     impression forming.   "
134651|NCT01522352|"     This study suggests for the first time a comparison of the hemodynamic performance of the two     most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available     since September 2010 at the University Hospital of Clermont Ferrand.   "
134652|NCT01522339|"     The purpose of this study is to determine the safety of a customized MRI scanner and gather     preliminary data on image quality in a group of 10 medically stable infants admitted to the     Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC).   "
134653|NCT01522326|"     The objective of this study is to determine the efficacy of metoclopramide in relieving the     symptoms of Acute Mountain Sickness (AMS).      It is our hypothesis that the combined antiemetic and analgesic effects of metoclopramide     (which has been study-proven to be effective in relieving symptoms of migraine headache) will     prove to be more efficacious in relieving symptoms of acute mountain sickness than the     standard, previously-studied analgesic medication, ibuprofen.   "
134654|NCT01522313|"     This study investigates the influence of perioperative changes in serum creatinine on     hospital length of stay and mortality.   "
134655|NCT01522300|"     The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis     in detecting the multicentricity of mammary tumor.   "
134656|NCT01522287|"     The goal of this project is to improve access to effective treatments for obsessive     compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT)     treatment. There intervention involves both a computer program (BT Steps) and human     interaction via telephone. The investigators will test the efficacy and feasibility of     computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus     a CBT therapist coach (n=35   "
134657|NCT01522274|"     This research study is for FEMALE cigarette smokers who want to quit smoking.      Participants will be provided with brief quit-smoking education at the beginning of the study     and will receive the nicotine patch for 10 weeks, free of charge.      Participants will be assigned to either an exercise program or a general health education     program. The exercise and health education programs will take place over 14 weeks, with     follow-up appointments 3, 6, and 12 months after the end of the 14-week program.      There is no fee for any part of this study and participants will be compensated for their     time.   "
134658|NCT01522261|"     Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with     visualization of the operative field during laparoscopic pelvic reconstructive surgery?   "
134659|NCT01522248|"     Some people experience symptoms just after receiving the seasonal inactivated influenza     vaccine. The cause of some of these symptoms is likely to be an immune response to the     vaccine. The investigators would like to look at the earliest immune responses to the     inactivated influenza vaccine. This pilot study will help us to determine at what time points     we should look.   "
134660|NCT01522235|"     The purpose of the study is to see if administering intravenous immune globulin (IVIG)     (putting immune globulin directly into your blood) helps to improve the symptoms of     orthostatic hypotension (sudden fall in blood pressure when a person stands up) and quality     of life in men and women who have autoimmune autonomic ganglionopathy (AAG).   "
134661|NCT01522222|"     To demonstrate that using continuous mechanical lung ventilatory support in combination with     Positive End Expiratory Pressure (PEEP)during open heart surgery will improve lung function     and decrease lung complications after surgery.   "
134666|NCT01522157|"     The trial will study the acute metabolic effects of three different types of diet: low-fat     diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus     type 2 will be recruited and each of them will be given each type of diet on three different     days. Menus with the same energy content but with different content of fat, carbohydrate and     protein are designed. Breakfast and lunch are served for the patients each day of testing.     Laboratory samplings are performed six times during the day. The order of the dietary     intervention is randomized for each patient.      The investigators suppose to find different reaction in plasma glucose and lipids depending     on the type of diet.   "
134667|NCT01522144|"     The Children's Hospital of Philadelphia's ambulatory network uses an electronic health record     (EHR) to document clinical information. Using the EHR, a clinical decision support tool will     be designed to help the primary care physician's in caring for children with asthma. The goal     will be to improve the primary care physician's use of the national Institutes of Health     guidelines for the best care for asthma. To study this EHR decision support tool, it will be     introduced into 5 practices while 5 other practices will have the existing asthma care     information. It will be determined whether the physicians in the practices with the decision     support tool are better at following the asthma guidelines. If the decision support tool     works...then it will be offered to others to use with their EHR systems.   "
134668|NCT01522131|"     Purpose: The proposed study will evaluate and compare the clinical response of using     bioresorbable collagen membrane alone or defect debridement with erbium Laser irradiation in     conjunction with bioresorbable collagen membrane in the treatment of Class II furcation     defects in maxillary and mandibular teeth. The study will examine whether there is a superior     regeneration potential when the laser energy is combined with membrane defect isolation.      Procedure: The study will use 2 groups, a control group and a test group with 16 patients in     each group, with severe chronic periodontitis having clinical or radiographic evidence of     Class II furcation defects in the buccal or lingual of the mandibular molars or Class II     furcation defects on the buccal of maxillary molars. 16 patients will serve as the control     group and open flap debridement with bioresorbable collagen membrane will be the mode of     treatment. Group 2: 16 patients will serve as the test group and will undergo open flap     debridement in conjunction with Er, Cr: YSGG laser irradiation and a bioresorbable collagen     membrane will be used.   "
134669|NCT01522118|"     Since prostate specific antigen (PSA) was introduced as a clinical screening tool for     prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced     disease. The present choice of treatment for men with localized prostate cancer lies between     active surveillance and radical therapy. Thus, the option of treating only the cancer within     the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very     controversial. At present there are no consistent scientific data on focal therapy and its     major effectiveness.      Focal therapy for prostate cancer is defined as therapy that selectively ablates known     disease while preserving existing functions, with the overall aim of minimizing lifetime     morbidity without compromising life expectancy.      The aim of the investigators study is to test if Magnetic Resonance guided Focused Ultrasound     ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer.      The study i designed as Phase 1, treatment & resection protocol. With this project the     investigators further aim to evaluate the safety and identify side effects of Magnetic     Resonance guided Focused Ultrasound in treating focal prostate cancer.      This design will also expand knowledge of the effect of Magnetic Resonance guided Focused     Ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted     after this non-invasive treatment.   "
134670|NCT01522105|"     5 Children > 3months and < 16 years with Gram-positive meningitis will receive a single dose     of daptomycin 24 hours after the first dose of ceftriaxone. 4-8 hours after daptomycin     administration a second lumbar puncture is performed to determine the peak concentration of     daptomycin in the cerebrospinal fluid. In parallel peak and trough level of daptomycin will     be measured in the plasma. The investigators anticipate that daptomycin penetrates into the     cerebrospinal fluid in bactericidal concentrations   "
134671|NCT01522092|"     Anxiety and depression are common in patients with severe chronic obstructive pulmonary     disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear     and indeed this may be the main cause for the for hospital admission. Patients prone to a     tendency to experience and communicate somatic distress in response to psychosocial stress     and to seek medical help for it are top of the frequent flyer league, costing the health     care economy dearly. This is a particular problem in Hull with the high levels of smoking and     urban deprivation combining to place the city at the bottom of the Department of Health COPD     league tables.      Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes     of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus     allowing the patient time to access the existing community based support services.   "
134672|NCT01522079|"     Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal     muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used but its     effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.      Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic     function in patients with spinal muscular atrophy types II and III.      Methods: Patients with spinal muscle atrophy type II and III will be recruited.     Electrocardiogram signals will be recorded for analyses of heart rate variability during air     stacking in supine and sitting position.   "
134692|NCT01521819|"     This is a pilot, single-center, interventional clinical trial in which subjects will receive     16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.   "
134693|NCT01521806|"     This study will examine the effects of a dietary fiber on insulin sensitivity in overweight     and obese women. The fiber will be added to snack foods and women will consume the foods for     four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in     another period. In a third period, no fiber will be added to the snack foods. Insulin     senstivity will be measured at the end of each treatment period.   "
134739|NCT01521208|"     The goal of this study is to show the superiority in survival at hospital admittance and in     neurological outcome on hospital discharge of continuous mechanical chest compression using     LUCAS device versus manual chest compressions in patients who suffered an out-of-hospital     cardiac arrest.   "
134673|NCT01522066|"     An alternative to general anesthesia - which puts a patient completely to sleep - is regional     anesthesia, where local anesthetic is injected under the skin to freeze or 'block' a nerve or     set of nerves. This method allows a patient to be awake during surgery and avoids any     unpleasant after-effects of general anesthetic. A regional block is normally performed by     inserting a needle under the skin so that the needle tip is near the nerve to be blocked,     followed by injection of a single shot of enough local anesthetic to block any sensation that     the nerve normally provides. Although regional nerve blocks provide pain relief during a     surgical procedure, they eventually wear off, occasionally leaving the patient to contend     with localized pain in the part of the body that was operated on. In these cases,     over-the-counter painkillers like Tylenol or Advil may not be strong enough to completely     take away the pain. We believe that, instead of giving a single shot of anesthetic, patients     can be fitted with a catheter - a thin, flexible tube - that can be used to deliver one dose     of local anesthetic to block the nerve before surgery and which could also be used to deliver     a second dose of anesthetic just prior to discharge from the hospital. This way, the patient     still only receives one needle poke, but their pain can be better managed following surgery.     Our study will compare the post-nerve block pain profiles of individuals who have received a     single-shot injection of local anesthetic versus those who have received two doses via the     catheter delivery method.   "
134674|NCT01522053|"     When anesthesiologists perform a regional nerve block, they will often put a catheter - a     flexible plastic tube - in the patient to allow for continuous delivery of local anesthetic.     This allows the nerve(s) to be 'frozen' so that the patient is more comfortable during and     after surgery. The most common method of placing the catheter close to a nerve involves     threading the catheter through a needle which has been inserted under the skin. Because the     catheter is very thin and flexible, it does not thread well through tissue and will buckle     and kink when enough force is applied to it. Another problem is that the puncture hole left     by the needle is larger than the diameter of the catheter, meaning that when the needle is     withdrawn, the catheter is not secure, which increases the chance that it will dislodge and     cause leakage of local anesthetic. One solution to these problems is to use a catheter     placement method similar to how intravenous catheters are installed. In this method, the     catheter fits around ('over') the needle, which results in more support for the catheter     while it is being pushed under the skin. We wish to examine if a catheter-over-needle method     would be useful for placing a catheter to deliver local anesthetic during peripheral nerve     blockade. We will compare the catheter-over-needle method to the currently used     catheter-through-needle method on patients who require continuous anesthetic delivery for     their surgery; half the patients will receive anesthetic through one method, and the other     half will receive anesthetic through the other method. We believe that using the     catheter-over-needle method will result in more secure placement of the catheter and more     efficient delivery of local anesthetic.   "
134675|NCT01522040|"     This is a prospective randomized pilot study that seeks to address the research question: In     children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard     Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from     patient presentation until PICU discharge?   "
134676|NCT01522027|"     Critically ill patients or patients under prolonged unconsciousness need a tube inserted into     their windpipe to provide oxygen. This tube, called a tracheostomy tube, can be connected to     a ventilation device to allow the patient to breathe when they cannot do it for themselves.     In the hospital, doctors will perform a percutaneous tracheostomy (PT), where a needle is     inserted through the skin of the neck into the windpipe, providing a guide for a tube that     will dilate the tissue and create a hole that the tracheostomy tube can be inserted into.     Although this is a common procedure in critical care units, it does carry some risks to the     patient and is not always successful. The needle may puncture the back or side of the     windpipe if it is inserted too far, or it can miss the windpipe altogether, causing damage to     surrounding structures. We believe that doctors who perform PT would benefit from a method     that improves the success rate of the procedure. We wish to test a device that alerts the     doctor performing PT to when the needle tip is in the air-filled windpipe. The device has     been proven to aid needle insertion in cadavers, but it needs to be tested on live patients.     Since many intensive care patients undergo PT, we wish to test our technique on this     population. It will be a controlled environment and the clinicians are experienced in PT.     This technique should save valuable time, result in more accurate needle insertion, and     lessen the risk of damaging other structures and tissues in the neck.   "
134677|NCT01522014|"     Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the     geriatric population. Numerous studies have reported good mid and long term results of THA in     patients over the age of 60 years. With the reported high success rate of this surgical     intervention, the THA surgery is being performed in younger patients who have significant     joint disease.      A clinical trial, using a randomized blinded design, was undertaken to compare the functional     outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners     in patients 60 years of age or younger with non-inflammatory arthritis of the hip.      Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year     follow-up is currently underway.      The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the     RAND-12, as well as measurement of complication and revision rates. The patient's demand on     the implant as calculated by the patient's age, weight, health status and activity level was     also measured.   "
134694|NCT01521793|"     The purpose of this study is:        -  To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once          daily for 7 days in subjects treated previously with a single 7-day course of QLT091001          in Study RET IRD 01        -  To evaluate whether up to 3 additional courses of oral QLT091001 administered once daily          for 7 days can maintain or improve visual function.   "
134695|NCT01521780|"     The purpose of this study is to characterize the baseline variability of a panel of tissue     (tumor and adjacent) and blood-based biomarkers obtained from participants with     hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80%     Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one     core needle biopsy (CNB) equivalent is =< 0.65.   "
134678|NCT01522001|"     Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people     suffering from Heart Disease. It involves;        -  Dietary counseling,        -  Exercise training,        -  Psychosocial support,        -  Physician        -  smoking cessation        -  Patient education      The purpose is quick and complete recovery and to reduce the chance of recurrence.      In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital     based cardiac rehabilitation at discharge.      The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the     Regions, who runs the hospitals, to the municipalities.      Shared care is in this setting that elements of treatment are completed different places in     Health Care.      The aim of this study is:        -  to establish a shared care model for Cardiac rehabilitation following admission with          Acute Coronary Syndrome and        -  to compare this model to the existing hospital based cardiac rehabilitation after          admission with Acute Coronary Syndrome.      Primary outcome is participation in cardiac rehabilitation.   "
134679|NCT01521988|"     - Background:      Atrial fibrillation is frequently associated with typical atrial flutter in clinical     practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved     in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation     that occurs in about 70% of these patients after several years of follow-up. However, the     latter arrhythmia is associated with significant morbidity and mortality. The problem of     atrial fibrillation occurrence after successful ablation of typical atrial flutter remains     physicians primary concern in monitoring these patients.        -  Objectives:      The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon     cryotherapy technology performed at the time of flutter ablation, significantly reduces the     risk of developing atrial fibrillation in the two year period following the procedure.        -  Selection Criteria:      Patients referred for ablation of typical atrial flutter with an history of at least one     documented episode of atrial fibrillation (atrial flutter remaining the predominant     arrhythmia)will be enrolled in the study.        -  Study Methods:      This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial     fibrillation occurrence over a two years period following either an ablation procedure of     typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation     and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18     months.      Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then     be regularly followed up clinically and by long-term ECG recordings.        -  Evaluation Criteria:      The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial     fibrillation, documented by an ECG or an R-test, occurring between M3 and M24        -  Number of patients:           170 patients will be enrolled in the study        -  Number of centers:      Four French and three German centers will participate.        -  Perspective:      The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the     patient group with pulmonary vein isolation, could lead to a modification of atrial     arrhythmia treatment indication.   "
134680|NCT01521975|"     Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an     individualized telbivudine treatment roadmap strategy designed to achieve optimal viral     suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes     adding ADV treatment at different time points according to individual patient response. China     CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP     strategy particularly, which may be a large potential to expand the naïve patients. We are     lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In     GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log showed a good 2 year     efficacy, but we still look forward to more efficient treatment and lower resistance rate.     This study complies with the principle of individualized therapy recommended and ethical     principles. It is expected that this study design with individualized treatment approach may     improve efficacy and lower the resistance rates. In addition, it will provide important     information on how to bring greater benefits to patients with CHB.   "
134681|NCT01521962|"     To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in     patients with diabetes when used in combination with insulin.   "
134682|NCT01521949|"     Men who have Prostate Specific Antigen (PSA) recurrence with low PSA levels and long doubling     times do not require immediate treatment with androgen deprivation therapy and may be safely     observed. In these situations where current treatment options may cause more unnecessary side     effects than anticipated benefit, it is reasonable to use a low-risk natural product such as     Acai Juice Product with antioxidant properties to evaluate whether there are any anti-cancer     effects.   "
134683|NCT01521936|"     This partially randomized phase II trial studies the side effects and best way to give and     best dose of cholecalciferol in treating patients with acute myeloid leukemia (AML)     undergoing intensive induction chemotherapy. Cholecalciferol may help improve the outcome of     patients with AML undergoing intensive chemotherapy   "
134684|NCT01521923|"     This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in     combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055     Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low     Disease Activity at Week 52 in study RA0055 Period 1.   "
134685|NCT01521910|"     The purpose of the investigators study was to determine the effect of dietary protein     restriction on survival and progression to end stage renal disease (ESRD) in diabetic     nephropathy.   "
134686|NCT01521897|"     This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3)     factors affecting safety in terms of the safety in infants starting to receive Prevenar at     the age of more than 2 and less than 7 months in routine medical practice.      This surveillance will specifically focus on the occurrence of the following:        1. Local reactions at the injection site        2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)   "
134687|NCT01521884|"     People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL.     In this study we are measuring the impact of SC biologics on these parameters.   "
134688|NCT01521871|"     By means of a prospective, randomised trial the investigators want to examine skin closure in     living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue     (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1;     30 + 30 donors).      Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least     as good as conventional suture regarding wound healing/complications. (ii) Peroperatively,     tissue glue is faster than conventional suture.   "
134689|NCT01521858|"     Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial     blood loss. The investigators will investigate the relationship between the various     hematologic variables and postoperative bleeding volume.   "
134690|NCT01521845|"     The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac     necrosis(CKMB and troponin I) and inflammation marker CRP.   "
134691|NCT01521832|"     This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics     of single and multiple escalating doses of SEN0014196.   "
134697|NCT01521754|"     The purpose of this observational registry is to evaluate the long-term effectiveness, safety     and performance of market-released Medtronic Neuromodulation products for Deep Brain     Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource     use and patient reported outcomes, such as health related quality of life will be assessed.   "
134698|NCT01521741|"     The objective of this study is to determine the level of symptoms, functional disability, and     changes in quality of life that breast cancer patients experience from changes in their     arm(s) during and after treatment for breast cancer. These problems are often associated with     transient or chronic lymphedema, numbness, reduced shoulder flexibility, and an altered     ability to use the arm for functional activities of daily living. The goal of this study is     to collect data to support the hypothesis that swelling and other impairments in the upper     extremities, causes a significant level of symptoms, functional disability and diminished     quality of life for patients. Furthermore the investigators hope to evaluate how symptoms in     the upper extremity (such as decreased functionality, sensory changes, pain or stiffness) are     related to early, low volume lymphedema.   "
134699|NCT01521728|"     The first questions asked by patients with a new diagnosis of Amyotrophic Lateral Sclerosis     (ALS) often include: Does exercise help slow the progression of the disease?, Is there any     harm in exercising?, or What type of exercise (endurance or resistance) is most     appropriate? At this time, however, there is a lack of answers for people who suffer from an     illness that affects their strength above all else. Yet the beneficial effects of exercise in     both healthy people as well as people with other diseases have been extensively studied and     resulted in recommendations about the types of exercise that are beneficial. In this study     the investigators will ask participants with ALS to exercise in one of three ways:     weightlifting (resistance exercise), stationary bicycling (endurance exercise), and range of     motion exercise (the current standard of care for ALS patients). The investigators will use     several different types of tests to determine whether one type of exercise is tolerated     better and is safer than another. The investigators will also collect information about how     the body responds to exercise in ALS. This study will help in the development of a larger     national study to understand how exercise can be combined with other treatments to     potentially improve strength and alter the course of the disease.   "
134700|NCT01521715|"     Patients with advanced renal cell carcinoma (RCC) are classified according to Memorial     Sloan-Kettering Cancer Center (MSKCC) criteria in three risk-groups: favourable, intermediate     and poor. To our knowledge there is only one study which examined the poor risk group (Hudes     et al.), which led to the approval of temsirolimus in this population. However temsirolimus     demonstrated a low response rate of 8.6% according to Response Evaluation Criteria In Solid     Tumor (RECIST) criteria and a Progression free Survival (PFS) of 5.5 months and not all     patients are suitable for temsirolimus treatment.      Thus, in clinical routine high-risk patients are also treated with multi Tyrosinkinase     Inhibitors (mTKI). To date, a prospective data acquisition and control of effectiveness of a     mTKI-treatment in high-risk patients has not been conducted.      Pazopanib was recently approved for the first-line treatment of advanced renal cell carcinoma     in Europe and the USA. In the pivotal Phase III trial only nine patients in the pazopanib     group were poor risk according to MSKCC risk criteria and no analysis of this subgroup was     performed. Therefore further data in this group of patients with high medical need is needed.      Currently there are no well-established predictive or prognostic biomarkers in RCC-mTKI     treatment. This is one of the most important scientific questions in this field. In addition     to the clinical endpoints in this study, the comprehensive biomarker program seeks to     evaluate biomarker candidates and will help to learn more about the effects of pazopanib on     the human organism.   "
134701|NCT01521702|"     The aim of this study is to test the additional value of neoadjuvant chemotherapy to the     standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).      This study will be performed in compliance with the study protocol, GCP (good clinical     practice) and the applicable regulatory requirements.   "
134702|NCT01521689|"     Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances     have established correlation between the quality of the response (in particular achievement     of negativity of minimal residual disease (MRD) and progression free and overall survival.     That is why MRD negative complete remission (CR) is the current goal in CLL treatment.      The association of Rituximab fludarabine cyclophosphamide leads to the best response rate     with 52 to 72% CR in medically fit untreated CLL patients. MRD results in this setting are     still preliminary and around 50%. However many other situations (unfit, elderly, relapse,     haematological toxicity leading to early interruption of treatment…) are associated with much     lower response rate that would be improved by consolidation treatment.      Monoclonal antibodies are the treatment of choice for consolidation because of sparing marrow     and targeting CLL cells. Alemtuzumab has been used for this purpose and results confirm     improvement of CR and MRD negative responses but alemtuzumab induced immunodeficiency lead to     unacceptable infectious complications. Rituximab monotherapy induces low response rate at     standard dose regimen. This is at least partially due to shaving of CD20, mechanism by which     CD20 is lost from the leukemic cells but these cells are not cleared. Using low doses of     rituximab reduced shaving and allowed CLL cells clearance by the mononuclear phagocytic     system. Such low doses of rituximab can be administered subcutaneously.      The investigators then propose subcutaneous low dose rituximab in consolidation to CLL     patients responding after induction but having not achieved MRD negative CR.   "
134703|NCT01521676|"     Research of predictive clinical and biological factors in breast cancer :      genomic, proteomic, mutation   "
134704|NCT01521663|"     The purpose of this study is to determine whether IPX159 is safe and effective in treating     symptoms of RLS in subjects with Restless Legs Syndrome.   "
134728|NCT01521351|"     A prospective study of 700 patients with coronary artery disease will undergo non invasive     evaluation of their carotid arteries by ultrasound and microwave radiometry. The patients     will be followed up for 3 years and their outcome regarding the cardiovascular events (death,     cardiac events, cerebrovascular events) will be recorded   "
134729|NCT01521338|"     The goal of this research study is to collect blood and urine samples from people who have     either the R117H type of CF or the non-G551D gating type of CF to be kept for future     research.We will also use some of the collected blood to measure the number of neutrophils.   "
134705|NCT01521650|"     Longer surgical procedures require intubation and there is a potential risk of contaminating     the lower airways with pathogenic bacteria from the mouth and oropharynx.      Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal     but those do occur among patients, both in those not so sick and patients with more severe     problems.      For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral     care with probiotics and this is a pilot study to explore the possibility of the same kind of     positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.      Randomisation        -  No prophylaxis        -  Preparation with a probiotic suspension before intubation.      Cultures        -  oropharynx             -  before treatment             -  after intubation             -  before extubation             -  day 1 postoperatively        -  tracheal secretions             -  after intubation             -  before extubation   "
134706|NCT01521637|"     Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during     their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on     one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an     attenuated loss in muscle fiber size.   "
134707|NCT01521624|"     Oxidative stress plays a key role in the pathogenesis of diabetes complications. Chronic     hyperglycemia and disturbed lipid regulation commonly seen in diabetes are the main causes of     this process. Despite the critical role of oxidative stress in diabetes, most clinical trials     with available antioxidants and vitamins have either failed to show any long term benefits or     have produced inconsistent results (10-11). There has been growing interest in establishing     the possible roles of oral hypoglycemic agents including Metformin in reduction of oxidative     stress. Metformin, the most common prescribed oral medication in type 2 diabetes, lowers     HbA1c around 1.5%, rarely causes hypoglycemia (compared with insulin or sulfonylureas), has     relatively few contraindications, its adverse effects are generally tolerable, does not cause     weight gain, is cheap, and is highly acceptable among patients. Given the long term benefits     observed with metformin use, a role in modulating oxidative stress is imputable. We designed     this study to evaluate the actions of metformin on oxidative stress in a group of     medication-naïve newly diagnosed type 2 diabetes patients.   "
134708|NCT01521611|"     To determine whether a radiolabelled antibody that targets the bone marrow (the 'anti-CD66')     can be administered safely to patients as part of the preparative treatment prior to     haematopoietic stem cell transplantation ('a bone marrow transplant'). Can the radiolabelled     antibody be shown to effectively target the bone marrow in these patients. If it can, could     this result in better outcomes after transplantation.   "
134709|NCT01521598|"     Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic     peripheral neuropathy pain (DPN).      Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with     painful diabetic peripheral neuropathy.      Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit     from the double-blind phase because of inadequate pain relief.   "
134710|NCT01521585|"     The principal aim of this study is to obtain safety and tolerability data when SEN0014196 is     administered orally over 12 weeks to male and female patients with Huntington's Disease.   "
134711|NCT01521572|"     The aim of this study is to assess the bronchodilator response of salbutamol on respiratory     mechanics of healthy individuals, smokers and COPD with varying degrees of airway     obstruction.   "
134712|NCT01521559|"     This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week     study to assess the efficacy and safety of Intravitreal Aflibercept Injection     (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary     to BRVO.   "
134713|NCT01521546|"     Duchenne muscular dystrophy (DMD), the most common muscular dystrophy, leads to skeletal and     cardiac muscle damage. Treatment of pulmonary complications has improved survival; however,     heart muscle disease or cardiomyopathy has emerged as a leading cause of death, typically by     the third decade. Although myocardial changes begin early, clinically significant heart     disease is rarely detected in the first decade of life. Consequently, DMD cardiomyopathy     frequently goes unrecognized (and untreated) until advanced (and irreversible).      Current DMD cardiovascular care guidelines recommend beta-blockers and angiotensin converting     enzyme inhibitors (ACEIs) when decreased ejection fraction (EF) is noted by echocardiography     (echo); however, this strategy has not significantly improved outcomes. Our team has recently     made a breakthrough in a mouse study, showing in a model that causes the same heart muscle     disease in humans with DMD adding an old medicine traditionally used for high blood pressure     and late-stage heart failure can actually prevent heart muscle damage. Because of this drug's     proven safety in both children and adults, it is ready to be studied immediately in an RCT in     patients with DMD to hopefully show, as we did in mice, that we can prevent the devastating     consequences of heart muscle damage.   "
134714|NCT01521533|"     The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in     combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in     previously treated patients with multiple myeloma (MM).   "
134715|NCT01521520|"     Type 1 diabetes results from the autoimmune destruction of the insulin-producing beta cells     of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically silent     with immune cells invading the pancreatic islets, a process termed insulitis, which     eventually leads to loss of beta cells in the islets. If enough beta cells are destroyed, the     body can not make enough insulin to maintain blood sugars in the normal range and clinical     diabetes develops. The purpose of this study is to assess the ability of magnetic resonance     imaging with ferumoxytol to detect changes in the pancreas associated with the insulitis of     type 1 diabetes.   "
134730|NCT01521325|"     This research is being conducted to determine the biodistribution of radiolabeled amatuximab     in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including     mesothelioma, pancreatic, ovarian or non small cell lung cancer.   "
134731|NCT01521312|"     Glucose ACCES study will explore the acute and long term (12-week treatment) effects of     saxagliptin in patients with impaired glucose tolerance during fasting and after a     standardised breakfast. The investigations will be performed on:        -  glycemic parameters        -  on cardiovascular parameters   "
134716|NCT01521507|"     The study objective is to evaluate the long-term treatment effectiveness for adult patients     with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow®     System to a standardized daily warm compress and eyelid hygiene control therapy over a     duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with other MGD     and dry eye treatments over a duration of up to 12 Months.      This is a post-market, non-significant risk, prospective and multi-center clinical trial     divided into two stages. The first stage from enrollment to 3 Months is an open-label,     randomized controlled design to compare the effectiveness of a single LipiFlow® System     treatment to a standardized daily warm compress and eyelid hygiene Control therapy with     Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage,     occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness     of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration     of up to 12 Months. Subjects are entered into the following subgroups based on the subject's     self-assessment of the adequacy of symptom relief and protocol-defined criteria for     additional treatment.        1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.        2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.        3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by          other MGD or dry eye treatment, as prescribed by the physician.   "
134717|NCT01521494|"     To investigate dose-response efficacy and safety in hemodialysis patients with     hyperphosphatemia.   "
134718|NCT01521481|"     The purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided     inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).   "
134719|NCT01521468|"     A large number of cardiac catheterizations are performed each year, primarily to diagnose     heart disease. However, a cardiac catheterization is an invasive procedure which is     associated with serious complications such as heart infarction, stroke, and death. Therefore,     there is a need for non-invasive procedures to diagnose coronary heart disease. The purpose     of this study is, therefore, to assess the diagnostic accuracy of non-invasive cardiac     imaging modalities for the detection of heart disease in patients presenting for the first     time to the cardiologist with chest pain.   "
134720|NCT01521455|"     The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide     250 Diskus when repeatedly dosed to Asthmatic patients.   "
134721|NCT01521442|"     The primary objective of the current study is to establish the safety and acceptability of     Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD)     among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)     Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga     Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism     of therapeutic action.   "
134722|NCT01521429|"     Approximately 85% of individuals with Mucopolysaccharidosis (MPS) type I, II, or VI report     weekly pain and 50-60% have significant limitations in their activities of daily living due     to MPS related musculoskeletal disease despite treatment with enzyme replacement therapy     (ERT). Thus there is a critical need to identify additional therapies to alleviate the burden     of musculoskeletal disease in order to improve the health and quality of life of individuals     with MPS. However, disease progression needs to be quantified to be able to determine     efficacy of new therapies. This study is a multi-institutional, 5-year, longitudinal study of     musculoskeletal disease in MPS. The objective is to quantitatively describe the progression     of skeletal disease and identify biomarkers that either predict disease severity or could be     used as therapeutic targets in individuals with MPS I, II, and VI. A database of standardized     measurements of musculoskeletal disease in MPS will allow the field to efficiently move     forward with therapeutic clinical trials in patients with MPS.   "
134723|NCT01521416|"     The objective of this study is to describe the burden associated with influenza in the UK,     from both primary and secondary care perspectives, and to stratify the burden by the annual     degree of mismatch between predicted and actual virus strains.   "
134724|NCT01521403|"     The objective of this study is to determine whether in the setting of primary health care it     is effective to treat with metronidazole returning travellers with gastrointestinal symptoms     and B. hominis in the stool or not.   "
134725|NCT01521390|"     GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being     developed for the treatment of chronic obstructive pulmonary disease (COPD). The long     duration of action of GSK573719, when administered via inhalation to humans supports the     potential for use as a long acting bronchodilator.This is a randomized, double-blind,     placebo-controlled, 5 period cross-over study in healthy male and female volunteers. The     study will measure lung function after single inhaled doses from two configurations of the     Novel Dry Powder Inhaler. Key assessments will include clinical relevant PD parameters: sGaw,     FEV1   "
134726|NCT01521377|"     This is a randomized, placebo controlled, four period incomplete block,crossover thorough QT     study to estimate the effect of repeat dose GSK573719/GW642444M (Vilanterol) combination and     GSK573719 monotherapy on the QTc interval in healthy male and female subjects compared with     placebo. At least 100 subjects will receive, four of five possible, 10-day repeat dose     treatments. Treatments are placebo with a moxifloxacin placebo on day 10, placebo with     moxifloxacin (400mg) on day 10, GSK573719/Vilanterol combination (125/25μg) with moxifloxacin     placebo on day 10, GSK573719/Vilanterol combinatio (500/100μg) with moxifloxacin placebo on     day 10, or GSK573719 (500μg) with a moxifloxacin placebo on day 10. All treatments are double     blind except for moxifloxacin (400mg) and moxifloxacin placebo controls, given as a     single-blind single dose on Day 10 of the appropriate treatment period.      Primary endpoints are individual time-matched changes from baseline QTcF for     GSK573719/Vilanterol combination (125/25μg) and GSK573719 (500μg), 0-24 hours after dosing on     Day 10. Secondary endpoints will include individual time-matched changes from baseline in     QTcF for GSK573719/Vilanterol combination (500/100μg) and moxifloxacin (400mcg) 0-24 hours     after dosing on Day 10. Also changes from baseline in QTci, QTcB, QT, QRS, RR, PR and     ventricular rate at each time point after 10 days dosing of each GSK573719 and     GSK573719/Vilanterol treatment and single dose moxifloxacin (400mg). Maximal change from     baseline 0-24hours after dosing on day 10 will be derived for QTcF, QTci and QTcB for each     treatment. Plasma concentrations on Day 10 (0-24 hours) and pharmacokinetic parameters of     GSK573719 and Vilanterol will also be derived. Key assessments: 12- lead electrocardiogram     (ECG), pharmacokinetics. Safety will be assessed by blood pressure, heart rate, clinical     laboratory safety tests and collection of adverse events (AEs).   "
134727|NCT01521364|"     Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA)     in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis     (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in     different Mycobacteria strains. The investigators observed increased LIN serum levels in     three cases after combining LIN and CLA of which the investigators described one in a case     report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic     study in MDR- and XDR-TB patients to quantify the above described interaction between LIN and     CLA.   "
134732|NCT01521299|"     This is an open label Phase I study with two parts. Part Two with SCH900776 in combination     with hydroxyurea will not be pursued at this time.      Part One investigates monotherapy with oral hydroxyurea. The primary objective is to     determine whether a tolerated dose (TD) of hydroxyurea as a single agent can increase the     percentage of tumor cells in S and G2 phase of the cell cycle. For this reason, all patients     in Part One must have a tumor lesion accessible for a skin punch biopsy. Tumor biopsies will     be obtained on two separate occasions: prior to hydroxyurea and at 16-18h after starting     hydroxurea therapy on day 1 only.      A baseline 12-lead ECG will be obtained from each study participant. Single-agent hydroxyurea     will be administered on days 1, 8 and 15 of a 28 day cycle, for ONE cycle only. On these days     oral hydroxyurea will be started in the late afternoon and administered every 4 hours for a     total of 6 doses.      Venous (up to 10 mL) blood samples will be obtained at time zero (pretreatment), 30 min, 1h,     1.5 2, 2.5, 3.0, 3.5 and 4h following the first oral dose of hydroxyurea, and pretreatment     and at the same times following the sixth oral dose of hydroxyurea (i.e., 20, 20.5, 21, 21.5,     22, 22.5, 23, 23.5 and 24 h).   "
134733|NCT01521286|"     The purpose of this study is to collect data on the incidence, complications and impact on     quality of life of herpes zoster (HZ) disease in adults >=50 years of age in Spain. This     study will also collect data on costs related to the HZ disease, especially postherpetic     neuralgia (PHN)   "
134734|NCT01521273|"     Iron deficiency and iron deficiency anemia are among the major health problems in the     developing world. Women of childbearing age as well as children are the most vulnerable     population groups. In Rwanda, more than 40% of the population is estimated to be anemic. A     promising approach to combat iron deficiency in Rwanda is biofortification of beans. The     average consumption of beans is about 150 g per person per day in Rwanda and beans are a     major staple food. Traditional plant breeding has increased the iron content of certain bean     varieties from about 5 to 11 mg/100g. Iron absorption from beans however is with about 2-3%     low because of high phytate and high polyphenol contents. A recently conducted study in     Rwanda showed that the total amount of iron absorbed from a biofortified high iron bean was     similar to the amount of iron absorbed from a control bean, which had a 50% lower iron     concentration. This was surprising since the subjects had a low iron status and where     therefore expected to maximize iron absorption. However, it was concluded that the additional     iron bred into the bean was not bioavailable most likely due to the strong inhibitory nature     of phytate in the high iron bean. To clarify that, a multiple meal study (iron absorption     study) in collaboration of the Human Nutrition Laboratory of ETH Zurich and the Medical     Faculty of the National University of Rwanda is planned. Subjects will receive two different     bean varieties (normal iron vs. high iron) in combination with other food ingredients typical     for that region. The bean varieties will be served with native phytate concentration,     partially dephytinized (50%) or totally dephytinized.      Subjects will be apparently healthy females of reproductive age (18-30y). Iron absorption     will be determined by stable isotope techniques.   "
134735|NCT01521260|"     Peri-implantitis is an infectious disease that resides in the mucosa surrounding dental     implants and also affects the supporting bone. Because the number of implants placed in     everyday clinical practice is continuously increasing, it is reasonable to anticipate an     increasing prevalence of peri-implantitis. However, from the literature there is very little     reliable evidence suggesting which could be the most effective interventions for treating     peri-implantitis.      The primary objective of this controlled clinical study is to evaluate the microbiological     effect of decontamination of the implant surface during the surgical treatment of     peri-implantitis using a chlorhexidine or placebo solution. The secondary objectives are to     assess both the clinical and the microbiological effectiveness of treatment of     peri-implantitis.      It is hypothesized that rinsing of the implant surface using a 0.12% chlorhexidine solution     does not lead to better microbiological and clinical results compared to rinsing with a     placebo solution.      The present study is a double-blind, placebo-controlled, randomized clinical trial.      Adult patients with at least one endosseous implant in the oral cavity with clinical and     radiographical signs of peri-implantitis will be included in this study.      Implants with peri-implantitis lesions will be surgically exposed, followed by mechanical     cleansing using curettes and gauzes and cotton pellets soaked in saline followed by either 1     minute of rinsing with a placebo solution (saline with appearance of chlorhexidine) (control     group) or 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride     (CPC) without alcohol (Perio-aid®) (test group). After 1 minute of saline rinsing the     gingival flap will be returned slightly apical (in order to reduce pockets) and will be     firmly sutured. For both groups the surgery is followed by 2 weeks of mouthrinses with 0,12%     chlorhexidine + Cetylpyridinium Chloride (CPC) without alcohol (Perio-aid®) two times daily     during 30 seconds.      The main study parameter is the microbial composition of the biofilm on the dental implant     surface. Secondary study parameters are bleeding on probing, probing pocket depth,     suppuration on probing, microbiological composition of the peri-implant sulcus, radiographic     marginal bone level on standardized intraoral radiographs, presence of plaque, presence of     calculus, marginal soft tissue recession implant failure, complications and adverse events.   "
134736|NCT01521247|"     Despite the clear and often stated need, a formal transition program does not exist for     asthma patients as they move from pediatric to adult care in Western Canada. This population     is not having their health care needs met. The investigators proposed study would evaluate a     well structured transition program designed to facilitate continuity of care for this at risk     patient population.      Primary hypothesis: A pediatric-to-adult asthma transition program will improve the     asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year     period.      Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma     control, decrease asthma exacerbations, and reduce health care utilization in young asthma     patients in the Calgary area over a 1 year period.   "
134737|NCT01521234|"     Regaining independent walking is the top priority for individuals recovering from stroke.     Thus, physical rehabilitation post-stroke should focus on improving walking function and     endurance. However, the amount of walking completed by individuals with stroke attending     rehabilitation is far below that required for independent community ambulation. There has     been increased interest in accelerometer-based monitoring of walking post-stroke. Walking     monitoring could be integrated within the goal-setting process for those with ambulation     goals in rehabilitation. The purpose of this study is to determine the effect of     accelerometer-based feedback of daily walking activity during rehabilitation on the frequency     and duration of walking post-stroke.   "
134738|NCT01521221|"     The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension     in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for     comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes     and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood     pressure, heart rate and symptoms will be continuously measured. First study will evaluate     the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before     the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the     position changes.   "
134740|NCT01521195|"     The investigators propose to examine the relationship between DO2 and VO2 in critically ill     patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can     provide complete support of heart and lung function. In so doing, the investigators will be     able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow     through the ECMO circuit.      Null Hypothesis:      Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not     associated with an increase in oxygen consumption.      Alternate Hypothesis:      Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is     associated with an increase in oxygen consumption.   "
134741|NCT01521182|"     The purpose of this study is to determine whether the regular consumption of the active     product enhances the immune function, in comparison to the control product.   "
134742|NCT01521169|"     The purpose of this study is to investigate the effect of consumption of a drinkable low fat     fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol     (LDL-cholesterol) concentration during 12 weeks of product consumption.   "
134743|NCT01521156|"     The purpose of this study is to investigate the cholesterol lowering effect of a drinkable     low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in     midly hypercholesterolemic people.   "
134744|NCT01521143|"     As < 10% of the necessary patients required by the protocol were recruited and the data were     not intended to support a labeling claim, it was determined that the abbreviated clinical     study report (CSR) was the appropriate reporting format. No efficacy analyses were performed     as the trial was terminated early with incomplete enrollment of < 10%.      The purpose of this study is to determine if an investigational cell therapy called Cvac can     help epithelial ovarian cancer (EOC) from returning when administered to patients who are in     complete remission after surgical removal of their tumor followed by standard first-line     (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo     leukapheresis for the manufacture of the study agent. After completion of chemotherapy and     confirmation of remission, patients will enter the treatment phase of the study.   "
134745|NCT01521130|"     This project examines how seizures, and abnormal brain activity, affect language skill in     children with Benign Childhood Epilepsy with Centro-Temporal Spikes (BECTS). BECTS is a     common type of childhood epilepsy, and while BECTS patients stop having seizures by their     late teenage years, many studies have shown that these children have language problems that     may lead to academic and social difficulties. Using standardized language testing, monitoring     of brain activity, and MRI brain imaging, this project aims to determine what particular     combination of BECTS symptoms put children most at risk for language problems and whether     treatment with anti-epileptic medications may be helpful.   "
134746|NCT01521117|"     This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and     muscle rigidity. Current medications for the treatment of PD do not improve gait and balance     difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in     individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The     investigators study will look at what aspects of gait and balance are improved by the study     drug. The study drug is not approved to treat PD in the United States or other countries     because we do not know enough about it.   "
134747|NCT01521104|"     Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of     invasive depth of colorectal neoplasia.   "
134748|NCT01521091|"     Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make     accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the     first choice.   "
134749|NCT01521078|"     Excessive alcohol consumption in university students continues for be a serious public health     concern with a variety of negative consequences. There have been a number of different brief     interventions developed to address this issue among university students. The current project     will add to this literature by evaluating the use of a personalized feedback intervention     (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine whether providing     access to the CYDU will result in short-term reductions in drinking. This issue is important     as use of these interventions is not a mandatory requirement for university students so the     issue is whether making materials of this type available leads to any reductions in risky     drinking. It is hypothesized that students provided access to the CYDU will display greater     reductions in drinking at a six-week follow-up as compared to students who were not provided     access to the CYDU.   "
134750|NCT01521065|"     The purpose of this study is to confirm the clinical and economic benefits of IRay treatment     with respect to the number of anti-VEGF injections and frequency of visits during the first     year after treatment for patients with wet Age-related Macular Degeneration (AMD).   "
134751|NCT01521052|"     Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in     elderly patients suffering from major depressive episode.      Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above,     currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil     (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor     threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be     conducted before starting the trial (screening), once a week for the trial duration and one     month following end of treatment.   "
134752|NCT01521039|"     Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).   "
134753|NCT01521026|"     This research on cognitive training addresses the following questions:        1. Does cognitive training lead to improved cognition, functional abilities, psychiatric          symptoms, treatment adherence, or quality of life in patients with psychoses?        2. What are the neurocognitive and non-cognitive factors that predict good outcomes          following cognitive rehabilitation? In addition to verbal learning and memory, immediate          verbal memory, vigilance, and executive functioning, the cognitive training intervention          attempted to improve prospective memory ability (i.e., the ability to remember to do          things in the future, such as take medications or attend a doctor's appointment).   "
134768|NCT01520831|"     This trial is conducted in Europe. The aim of this trial is to demonstrate a difference     between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic     insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.   "
134754|NCT01521013|"     When patients present with both a chronic disease and depression, family physicians agree     that treatment and follow-up is more complicated and that patients' health suffers as a     result. Programs to help depressed patients learn skills to help manage their mood have been     developed (depression self-care), using workbooks and audio-visual materials. The programs     show promise, but little is known about how these self-care programs may work for patients     with depression and chronic disease.      Researchers are proposing a study to evaluate a depression self-care programme for patients     age 40 and over who have at least mild depressive symptoms as well as a chronic physical     illness and who are treated primarily by a family physician. All study participants (250     patients selected from different family medicine clinics in Montreal) will receive a package     of depression self-care materials which include the Antidepressant Skills Workbook, developed     in Canada, available in French and English, and used in several provinces in depression     self-management programs; a video on depression; a mood monitoring tool; an information     booklet to give to family members; and information on additional resources (books, internet     materials, and local community groups). The participants will be assigned to one of two     groups randomly (like a coin toss): one group will receive the materials only, the other     group will receive the materials as well as regular telephone support for up to 6 months by a     trained coach who will answer any questions the participant may have on the materials they     are working with.      All participants who agree to be in the study will be interviewed three times: once at the     beginning of the study, then at 3 months and finally at 6 months. Patients' depression scores     will be evaluated to determine the effectiveness of the self-care programme with and without     the support of the coach. Researchers will also look at the effect that self-care may have on     use and costs of health services, and whether engaging in self-care has an impact on health     behaviours (like exercise, taking medications correctly and smoking and alcohol consumption).      All study data will be anonymous; any information that could potentially allow identification     of a participant will be removed.   "
134755|NCT01521000|"     Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet)     in patients with pre-clinical lymphedema can halt the progression of lymphedema.      Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to     measure pre-clinical and clinical lymphedema.      Tertiary Objective: To determine whether bioimpedance analysis is better than the gold     standard of volume displacement to measure lymphedema.      The successful completion of this study will address whether bioimpedance analysis is a     reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we     intend to evaluate whether bioimpedance analysis is better than the gold standard of volume     displacement for measuring lymphedema. And most importantly, we will evaluate whether a short     trial of compression garments in women identified to have pre-clinical lymphedema can     actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the     research and findings of this study, which may have future bearing on the post-operative     therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.      Study Design:Randomized, Pilot Study   "
134756|NCT01520987|"     To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects   "
134757|NCT01520974|"     The purpose of this study is to determine if an oral probiotic tablet taken once a day for     twelve weeks can decrease the numbers of bacteria that are associated with tooth decay and     gum disease in a dentally healthy, young adult population.   "
134758|NCT01520961|"     Hueter anterior approach as described by Siguier allows an anatomical approach without muscle     or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty     (1.5%, Sariali)and seems to allow quicker rehabilitation.      The investigators hypothesis was Hueter anterior approach allows quicker functional recovery     after partial hip replacement.   "
134759|NCT01520948|"     Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of     tremor, slowness of movement, and stiffness, leading to progressive disability and loss of     independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI),     urgency, and/or nocturia, are common non-motor symptoms that further diminish the already     compromised quality of life for adults living with PD. Behavioral interventions for UI -     including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized     controlled trials and are free of side effects. Exercise-based behavioral therapy for UI     requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral     strategy that incorporates the PFME to suppress urinary urgency and prevent UI.      We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based     behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI     severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be     randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to     achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month     follow-up is planned in the treatment group.      We hypothesize that:        1. PD participants who are randomized to the exercise-based behavioral therapy group (Group          A) will report a significant reduction in weekly frequency of UI episodes compared to PD          participants in the behavioral control group (Group B). The primary outcome, frequency          of UI, will be measured using a seven-day bladder diary.        2. Compared to PD participants in Group B, the reduction in UI frequency in Group A will be          clinically meaningful as measured by a corresponding improvement on questionnaires of          satisfaction and quality of life as well as a decline in other urinary symptoms          including urgency and nocturia.   "
134760|NCT01520935|"     The study will assess the burden of influenza by age, risk status, vaccination status and     influenza subtype, in order to create a complete profile of the burden of influenza-related     morbidity and mortality in United Kingdom from 1996 to 2008.   "
134761|NCT01520922|"     This is a Phase II, open label, single arm, multi-centre study investigating the safety and     efficacy of ofatumumab plus bendamustine in subjects with untreated or relapsed CLL.      Each subject from the screening phase who is willing to participate in the study and is found     eligible according to the inclusion and exclusion criteria will enter the treatment phase and     will receive a maximum of 6 Cycles of study treatment (ofatumumab plus bendamustine). All     subjects will receive 3 Cycles of study treatment (Cycles 1, 2 and 3). Eligibility to receive     study treatment for Cycles 4, 5 and 6 will be assessed following the 3rd Cycle. Subjects who     have achieved at least stable disease with acceptable toxicity following 3 Cycles of     treatment will be eligible to continue to receive study treatments for a maximum of 3 further     Cycles. In case of progressive disease, at, or at any time after the start of Cycle 4,     subjects must discontinue further study treatment and move into the study's follow-up period.      During the treatment phase, all eligible subjects will be allocated to receive the following     study treatments:        1. Subjects with Untreated CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle          1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in          combination with up to 6 Cycles of intravenously infused bendamustine (90 mg/m2, Days 1          and 2, every 28 Days).        2. Subjects with Relapsed CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle          1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in          combination with up to 6 Cycles of intravenously infused bendamustine (70 mg/m2, Days 1          and 2, every 28 Days).      The studies primary endpoint is overall response rate (ORR) as determined by Investigator     evaluation. The ORR is the percentage of subjects achieving an objective response (i.e.,     partial response or better), using the IWCLL updated NCI-WG guidelines. Response assessments     are planned at the following time-points: After 3 Cycles of ofatumumab plus bendamustine     treatment, after 6 Cycles of ofatumumab plus bendamustine treatment and after the last dose,     if not after 6 cycles, of ofatumumab plus bendamustine treatment.      Follow-up assessments will be performed every 3 months following the last study treatment.     The follow-up period will last for a maximum of 3 years. Response evaluation assessments to     determine subject response or progression will be performed during the follow-up period,     according to the IWCLL updated NCI-WG guidelines. Following progression, only survival status     and details concerning the subject's next CLL therapy will be recorded.   "
134762|NCT01520909|"     The purpose of this study is to investigate the efficacy, safety and tolerability of     eltrombopag in children with previously treated chronic immune thrombocytopenia who are     between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized     to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will     enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.   "
134763|NCT01520896|"     Study in healthy volunteers to investigate the effects of Ketoconazole on the     Pharmacokinetics of NKTR-118   "
134764|NCT01520883|"     Many patients suffering from asthma are not compliant to their treatment and consequently,     are not well controlled. Shared decision making intervention has shown an improvement in the     outcome of patients with chronic disease. The aim of this study is to evaluate decisional     conflict and to assess decisional needs of adults with asthma.   "
134770|NCT01520805|"     The purpose of this study is to determine whether CPI-613 is effective and safe in either     patients with refractory or relapsed acute myeloid leukemia (AML) or patients with     myelodysplastic syndrome (MDS) who have failed therapy with a hypomethylating agent (such as     decitabine [Vidaza] and azacitidine [AZA]).   "
134771|NCT01520792|"     Recent works has emphasized that the mechanism of action of paracetamol analgesic depend on     its metabolism in the body, since a breakdown product of paracetamol, the AM404 is now     considered the analgesic metabolite of paracetamol suggesting as paracetamol may be a     pro-drug.      Indeed, it has been shown that paracetamol may have a deleterious effect, especially in     vulnerable populations (hepatic insufficiency, elderly). First results showed a very     significant decrease in sulfatation and gluthatione and increased phase 1 metabolism of     acetaminophen, which involves enzymes such as cytochrome P450.      Multifactorial causes, combining nutrition (depletion of sulfur amino acids), increased     detoxification of toxic metabolites of paracetamol, stress or trauma are discussed to explain     the results.      Clinical studies showed a great variability of pain assessment by patients and variability in     the metabolic response of paracetamol. Genetic factors probably play a role remains largely     unknown.      The review of the literature on genetic polymorphism shows the involvement of a number of     enzymes that are well known, predominantly on the metabolism of acetaminophen liver, but     without connection with its analgesic effect. This is a critical missing link in the     understanding of the analgesic effect of paracetamol.   "
134772|NCT01520779|"     analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular     carcinoma within 1 year after radiofrequency ablation.   "
134773|NCT01520766|"     A randomized parallel-group clinical pilot study was designed to evaluate the impact of glass     fiber reinforced composite posts compared to prefabricated titanium posts on long term     survival of adhesively restored endodontically treated abutment teeth.   "
134774|NCT01520753|"     This trial is conducted in Europe. The aim of this trial is to compare two different active     treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.   "
134775|NCT01520740|"     This study will evaluate the effects of baseline collateral ventilation status on outcomes     following treatment with AeriSeal System in patients with advanced upper-lobe predominant     heterogenous emphysema.   "
134776|NCT01520727|"     The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and     catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after     single oral ascending doses.   "
134777|NCT01520714|"     The purpose of this study is to determine whether changes in a patient's position affect LV     capture thresholds in a clinically significant way.   "
134778|NCT01520701|"     The investigators hope to get by reduced and delayed acute radiodermatitis following the     application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and     improved quality of life of patients with head and neck cancer treated with concomitant     radiotherapy.   "
134779|NCT01520688|"     Children with mild persistent asthma that have asthma symptoms once or twice a week and use a     daily controller, while children with mild intermittent asthma rarely have asthma symptoms     and do not use a daily controller. Inhaled corticosteroids are the standard treatment for     mild peristent asthma. The purpose of this study is to measure children rate of growth while     on different inhaled corticosteroids.   "
134780|NCT01520675|"     Chronic pancreatitis is a progressive inflammatory disease of the pancreas characterized by     destruction of pancreatic parenchyma and subsequent fibrosis. Patients with chronic     pancreatitis can be treated with medical management, endoscopic therapy and surgical     treatment. Among the various theories of causation of pain in chronic pancreatitis, there is     theory of ductal hypertension. In this the pancreatic duct obstruction resulting in ductal     dilatation, ductal hypertension and parenchymal hypertension is thought to be the cause of     pain. For patients with dilated ducts, ductal decompression is advocated. Ductal     decompression can be achieved by endoscopy and by surgery. Surgery comprises of lateral     pancreaticojejunostomy with or without headcoring. Endoscopic treatment includes     sphincterotomy, dilatation of strictures, removal of stones with or without extracorporeal     shock wave lithotripsy (ESWL) and stenting. The pros and cons of endoscopic versus surgical     therapy are debated. Lateral pancreaticojejunostomy relieves chronic abdominal pain in     65%-93% of patients. Morbidity and mortality rates are generally low, averaging 20% and 2%,     respectively. Long-term follow-up of patients after lateral pancreaticojejunostomy reveals     that up to 50% of patients develop recurrent symptoms and 10%-35% fail to obtain pain relief.     Studies indicate that more than 60% of patients undergoing pancreatic endotherapy are pain     free 1 year after the procedure. There are only two randomized controlled trials comparing     endoscopic treatment with the surgical therapy. In this study the investigators will be     conducting a randomized trial, to compare endoscopic and surgical treatment of chronic     pancreatitis. Outcome variables measured in the study will include pain relief, quality of     life, morbidity, mortality, length of hospital stay and changes in pancreatic function.   "
134781|NCT01520662|"     Building upon our experience with a very sophisticated preventive services prompt and     reminder system, the Preventive Services Reminder System (PSRS), the investigators propose to     conduct a systematic three-year study with the following aims:        1. To develop, field test, and refine an Internet-based patient Wellness Portal linked to          PSRS to facilitate patient-centered, preventive care in primary care practices;        2. To determine the impact of the Wellness Portal on the process of patient-centered          preventive care by examining the behavior and experiences of both patients and providers          and the degree to which recommended services are individualized; and        3. To develop model Wellness Portal practices and disseminate the Wellness Portal          technology and knowledge derived from Aims 1 and 2 findings.   "
134782|NCT01520649|"     This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in depressed     human subjects study.   "
134783|NCT01520636|"     This study is designed to observe the respective effects of 2 types of physiotherapy early     after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered     (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative     physiotherapy aiming at preventing complications.   "
134905|NCT01519050|"     The aim of the study is to investigate whether a predictive score (combination of several     validated predictors) better predicts postoperative left ventricular function than any single     predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.      A single center, prospective cohort study   "
134832|NCT01519999|"     The purpose of this study is to increase colorectal cancer screening by implementing a     community-wide shared decision-making (SDM) intervention, which embeds shared decision making     within clinical practice and also uses an extensive community engagement campaign. The     investigators hypothesize that colorectal cancer screening adherence will be higher in the     intervention group (participating communities) compared to the usual care control group     (non-participating comparison communities).   "
134784|NCT01520623|"     Allogeneic haematopoietic stem cell transplantation (HSCT) often remains the only curative     treatment for haematological malignancies. The anti-leukaemic effect of allogeneic HSCT,     called the GvL (Graf-versus-Leukemia) effect, is often associated to the development of an     immune response against healthy recipient cells leading to a graft-versus-host disease (GvHD)     in 20 to 70% of allogeneic HSCT. Acute GvHD, that usually targets the skin, the     gastrointestinal (GI) tract and the liver, is an important cause of morbidity and mortality     after allogeneic HSCT, particularly in the case of GI GvHD. The main goal of the research in     the field of allogeneic HSCT is to determine strategies that could decrease the risk of GvHD     without affecting the GvL effect. According to GVHD experimental models, it is likely that     GvL but not GvHD may occur in the absence of inflammatory signals induced by the     transplant-associated conditioning. Based on this hypothesis, we have chosen to analyse the     role of Complement system in patients who received allogeneic HSCT. Indeed, Complement system     is a major actor of inflammation and in the generation of tissue destruction, both of which     are involved in the physiopathology of GVHD. Furthermore, it might be a potential target of     some available inhibitory drugs (purified C1-Inhibitor, anti-C5 antibodies) in a preventive     or curative manner in such patients. Preliminary data obtained from 34 allografted patients     in our institution suggest that Complement activation by the classical pathway is correlated     to the occurrence of GI GVHD. The goal of our current project, in order to confirm these     preliminary results in a larger series, is to explore Complement system activation in     patients who received allogeneic HSCT in three Adult Hematology departments in Paris fot two     years and to correlate the biological results to the clinical events occurring after HSCT.   "
134785|NCT01520610|"     This is a case-control association study with multicentric prospective recruitment.      Tako-TSUBO cardiomyopathy is a new clinical entity mimicking an acute coronary syndrome. It     is characterized by reversible left ventricular dysfunction that is frequently precipitated     by a stressful event and most of patients are postmenopausal women.      Several hypotheses concerning pathogenesis of Tako-TSUBO cardiomyopathy have been proposed,     but at present, exaggerated sympathetic stimulation is the main hypothesis. However, the     investigators don't know why some patients with stressful event may present Tako-TSUBO     cardiomyopathy whereas most of them don't.      The investigators hypothesize that polymorphisms in the genes involved in the adrenergic     pathway resulting in greater catecholamine sensitivity would be associated with an increased     risk of Tako-TSUBO cardiomyopathy.   "
134786|NCT01520597|"     Listeriosis is a foodborne infection responsible for severe disease. Three main forms are     described: septicaemia, central nervous system infections and maternal-fetal infections.     Available data on the disease, are mostly retrospective and do not provide an accurate     picture of the clinical / biological / genetic risk factors for the disease, nor identify any     element to determine which patients are at higher risk of death, severe neurological     impairment or fetal loss.      The primary purpose of the study is to identify clinical, biological and genetic risk factors     for systemic listeriosis and the determinants of listeriosis-associated mortality in the     setting of a large prospective nation-wide study.   "
134787|NCT01520584|"     The vitamin,minerals and amino acid supplementation for 3 months will improve the semen     parameters,fertilization rate and embryo quality in subfertile men undergoing IVF treatment   "
134788|NCT01520571|"     The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide     better alignment and clinical function? (2) Do computer-assisted TKAs provide better     survivorship of implants and less complication? and (3) Do correction of the mechanical axis     of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery     due to aseptic loosening?   "
134789|NCT01520558|"     This is a multi-center, open-label, non-controlled, non-randomized dose-escalating Phase 1     clinical study designed to examine the safety of infusing escalating doses of     CNDO-109-Activated Allogeneic Natural Killer Cells-(from a first or second degree relative),     after a preparatory chemotherapy regimen, in adult patients with acute myeloid leukemia (AML)     who are in their first complete remission at the time of enrollment, are not candidates for     stem cell transplant, and are considered to be at high risk for recurrence.   "
134790|NCT01520545|"     Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump   "
134791|NCT01520532|"     The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral     lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed     using best practices, including optimized procedural techniques and anti-coagulation therapy.   "
134792|NCT01520519|"     The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with     rituximab can help to control CLL and SLL. The safety of this combination will also be     studied.      Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer     cells to die or stop growing.      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to     die.   "
134793|NCT01520506|"     The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy     through the wall of the renal artery to denervate the human kidney.   "
134794|NCT01520493|"     Pulmonary artery hypertension (PAH) is a rare, severe disease, characterized by a progressive     increase in pulmonary vascular resistance ultimately leading to right ventricular (RV)     failure and premature death. PAH may be idiopathic (IPAH) or may be also related to various     conditions like portal hypertension, HIV infection, left to right shunt, connective tissue     diseases such as scleroderma (PAHSSc). Symptoms include dyspnea and fatigue resulting in     restricted exercise capacity and poor quality of life. The therapies currently approved have     been shown to improve survival. Indeed, recent studies described a three year survival higher     than 80%. This improved survival is associated with major challenges for clinicians as most     patients remain with limited exercise capacity and poor quality of life. A clear     understanding of exercise physiopathology is thus mandatory to specifically address     mechanisms responsible for this exercise limitation and eventually improve patients'     management. In order to better characterize the exercise physiopathology in PAH, the general     objective of this research is to systematically examine blood flow distribution and limb     muscles microcirculation at rest and during submaximal exercise in PAH.   "
134795|NCT01520480|"     In this study, the investigators analyze a consecutive series of patients operated for     pathological subtrochanteric femur fracture to describe survival and reoperation rates after     surgery and to identify risk factors for death. Moreover, the investigators include a cohort     of patients with non-pathological subtrochanteric fractures for comparison.   "
134906|NCT01519037|"     The aim of this study is to evaluate, in healthy volunteers, the acute modulating effect of     cinacalcet on the RAAS, the effect of furosemide on parathyroid secretion of PTH and the     interaction between furosemide and cinacalcet on parathyroid hormone secretion.   "
134796|NCT01520467|"     There is currently no drug with pediatric marketing authorization capable of limiting the     advance in bone maturation of children with aggressive adrenarche. Estrogens are the     principal actors involved in bone maturation and premature epiphyseal fusion. Aromatase     inhibitors, used for the treatment of hormone-dependent cancers, block the transformation of     androgens into estrogens. Third generation inhibitors, of which Anastrozole is one, appear to     be well tolerated in children and are sometimes used within the framework of clinical trials     to limit bone maturation and improve prognosis with respect to final size, notably in     children treated with growth hormone (GH) due to a GH deficit. Nevertheless, the data     reported are based on small sample sizes and do not include children with pathological     adrenarche.   "
134797|NCT01520454|"     Obese people have elevated levels of the hormone leptin. Despite this, they seem to be     resistant to the effects of this hormone, which usually regulates appetite and energy     expenditure. This is similar to what happens with insulin levels in the obese. Furthermore,     the way lipid ingestion versus lipid infusion may impact novel molecules secreted by tissues     commonly affected in insulin resistant states such as liver and muscle have not yet been     studied.      The aim of the present study is to investigate the effect of oral vs. different doses of IV     lipid administration on molecular parameters related to glucose and energy homeostasis using     a randomized, placebo-controlled design.      Additionally, we will examine how increased free fatty acids (FFAs) my impact intracellular     leptin signaling such as the STAT3 pathway.   "
134798|NCT01520441|"     This is a pilot study examining biological endpoints in men with localized prostate cancer     who are scheduled to have radical prostatectomies and men with Benign Prostatic     Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A)     injection. Patients will serve as their own controls by receiving BoNT-A injections into the     right peripheral and transition zones and sham saline injections into the left peripheral and     transition zones.   "
134799|NCT01520428|"     The purpose of this study is to evaluate the effectiveness of diabetes management training     combined with the method of Motivational Interviewing with elements of Cognitive Behaviour     Therapy and E-mail support in the treatment of type 1 diabetes in adolescents (age range     13-20 years) compared to a control group. The investigators assess motivational changes and     effects on metabolic control.   "
134800|NCT01520415|"     The objective of this study is to examine the short and long-term effect of myofascial     trigger point injections with either a local anesthetic or saline in patients with chronic     low back pain presenting with myofasical pain syndrome.   "
134801|NCT01520402|"     The purpose of this study is to determine the importance of genetic differences on     individuals' response to warfarin in a group of healthy subjects. Warfarin is also known by     the trade name Coumadin and is in a class of medications called anticoagulants or blood     thinners. Warfarin works by reducing the blood's ability to make clots. It is used to stop     blood clots from forming or growing larger in your blood and blood vessels. Warfarin is     prescribed for many conditions, including for people with certain types of irregular     heartbeat, people with replacement or mechanical heart valves, people who have suffered a     heart attack, people who have had orthopedic surgery, or who have a history of having blood     clots. Warfarin is used to prevent or treat deep vein thrombosis (swelling and blood clot in     a vein), pulmonary embolism (a blood clot in the lung), and strokes (a blood clot in the     brain). Researchers have found that certain genes may affect how a person's body will break     down or react to warfarin. If genetic information can help doctors better determine the best     dose of warfarin before it is first given, this may help the doctors get patients to the     correct levels of blood thinning and thereby reduce the risk of bleeding or the risk of     developing a blood clot. The expectation of this study is that this information will     ultimately improve warfarin therapy while lessening the risks associated with dosing errors.     This study is considered investigational because the subjects are healthy and not being     prescribed warfarin for clinical care.   "
134802|NCT01520389|"     This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3     design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in     combination with irinotecan.   "
134803|NCT01520376|"     This study will try to elucidate wheter the impact of a psychiatric intervention in patients     hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at     1 and 6 month after discharge.   "
134804|NCT01520363|"     Dr. Sakkubai Naidu, Principal Investigator, is initiating a double blinded placebo controlled     clinical drug trial using dextromethorphan (DM) in Rett Syndrome (RTT), at the Pediatric     Clinical Research Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger Institute.      Funding Source- FDA OOPD and the Johns Hopkins Institute for Clinical and Translational     Research (ICTR).      It has been shown that receptors for a certain brain chemical called glutamate, in particular     the NMDA type, are increased in the brain of young RTT patients (<10 years of age). This     chemical and its receptors, when in excess, cause harmful over-stimulation of nerve cells in     the brain, contributing in part to the seizures, behavioral problems, and learning     disabilities in RTT.      The investigators propose to initiate a specific treatment using DM to counter/block the     effects of this brain chemical and its excessive receptors to improve the ill effects of     increased glutamate/NMDA receptors, because of DM's identified ability to block NMDA     receptors. DM is available for human consumption. Infants and children with respiratory     infections and cough, as well as non-ketotic hyperglycinemia, are treated with DM, which has     been well tolerated.   "
134816|NCT01520207|"     Kidney failure can result from a variety of conditions and can be temporary or permanent.     Hemodialysis is available as a replacement treatment to perform the work that the kidneys     normally do. However, the dialysis procedure can be associated with rapid changes in the     composition of the blood - this may lead to changes in blood pressure and in turn reduced     blood supply to important parts of the body. We aim to investigate if giving a medicine     (called mannitol) during dialysis may be able to reduce the frequency of these low blood     pressure events.   "
134817|NCT01520194|"     Considering the importance of HPV(human papilomavirus) and related diseases in Brazil, and     the lack of studies about both the economic and the psychosocial burden of these diseases,     BEMFAM, a Brazilian non-governmental organization that provides reproductive health services     and technical support to local governments proposes a study to measure the psychosocial and     economic burden of genital warts.   "
134805|NCT01520350|"     Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to     other antipsychotic agents, especially because of its partial dopaminergic agonistic     activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the     5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties     should enable this molecule to provide antidepressant potentiating capabilities based on what     has been observed with other compounds sharing similar pharmacological profiles.      Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the     treatment of unipolar depression. However, two randomized controlled trials of aripiprazole     in the treatment of bipolar depression were negative. This surprising result may stem from     the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3     mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit     dopaminergic activity in key brain areas involved in the modulation of rewards, motivation     and concentration. Bipolar depression is indeed heavily loaded with general symptoms of     psychomotor retardation including poor concentration, low energy level, hypersomnolence, and     hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving     dopaminergic function are used frequently to resolve residual symptoms of bipolar depression.      It is expected that aripiprazole used at a more adequate lower dose than in previous studies,     should be efficacious in the treatment of bipolar type I depression.   "
134806|NCT01520337|"     Polyp detection rate in colonoscopy following oral administration of MMX methylene blue     tablets   "
134807|NCT01520324|"     Evaluation of the intraepithelial neoplasia detection rate in patients with long standing     ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to     colonoscopy.   "
134808|NCT01520311|"     The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph     (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of     Duplex Sonography Results and coronary angiography and major cardiovascular or     cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein     (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.   "
134809|NCT01520298|"     This research study is a prospective, randomized, blinded, placebo controlled trial     evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip     fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have     the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All     patients diagnosed with a hip fracture aged at least 65 years and expected to undergo     surgical intervention are eligible to participate. Hip fractures affect greater than 300,000     geriatric patients annually, representing the second leading cause of hospitalization for     this patient population. Pain control in these patients is often problematic due to     co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects     may receive the normal DVT prophylactic treatments post-op.   "
134810|NCT01520285|"     This study will be compare Felodipine sustained-release tablets, to Lercanidipine     hydrochloride tablets (Zanidip®) for the treatment of patients with mild-to-moderate primary     hypertension and to investigate the influence on patients' heart rate and blood pressure     variability.   "
134811|NCT01520272|"     Background:      - Cervical cancer is one of the leading causes of cancer death in women worldwide and in     Uganda. It is caused by the human papillomavirus (HPV). A vaccine against HPV was offered for     all 10-year-old girls in the Nakasongola district of Uganda from October 1, 2008, to October     31, 2009. The HPV vaccine requires three doses; however, some girls received only one or two     doses. Researchers want to compare vaccine immunogenicity in girls who received all three     doses with those who had only one or two doses.      Objectives:      - To examine the immunogenicity (antibody levels) of girls in Uganda who received only one,     two or three doses of HPV vaccine.      Eligibility:        -  Girls who will be at least 12 years old by October 31, 2011, and had at least one dose          of the HPV vaccine.        -  All participants will come from the Nakasongola district of Uganda.      Design:        -  Participants will have a physical exam and answer questions about their medical history          and HPV risk.        -  Participants will provide a single blood sample for testing.        -  Treatment and vaccines will not be provided as part of this study. Girls who did not          receive all three doses of the HPV vaccine will be given information about the nearest          health center. Health centers will provide the missed doses free of charge.   "
134812|NCT01520259|"     Background:      - Chile has the highest diagnosis and death rates of gallbladder cancer in the world.     Gallbladder cancer is also the leading cause of cancer death in Chilean women. High rates of     gallstones and obesity, as well as genetic concerns, may explain these high rates.     Researchers want to study gallbladder cancer in more depth in Chile. A small study must be     done to see if a full-scale study is feasible.      Objectives:      - To test the methods and procedures of a small-scale study of gallbladder cancer in Chile.      Eligibility:        -  Individuals at least 18 years of age who have gallbladder cancer or gallstones, or are          healthy control volunteers.        -  Participants will be recruited from four clinical centers in Chile.      Design:        -  Participants will be screened with a physical exam and medical history. Because          gallbladder cancer has a high fatality rate, family members may be asked to provide          additional medical history information if study participants die or become too ill to          provide this information.        -  Participants will provide blood, urine, stool, hair, fingernail, and saliva samples.        -  Gallstones, bile, and tissue samples will be collected from those who have gallbladder          removal surgery. Normal and tumor tissue samples will be collected as needed.        -  Treatment will not be provided as part of this protocol. This is a data collection study          only.   "
134813|NCT01520246|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors identify and learn more about biomarkers related to cancer. It may also help     doctors find better ways to treat cancer.      PURPOSE: This research trial studies gene expression in samples from patients with T-cell     acute lymphoblastic leukemia.   "
134814|NCT01520233|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in RNA and predict how patients will respond     to treatment. It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial studies gene expression in predicting outcomes in samples from     patients with high-risk neuroblastoma.   "
134818|NCT01520181|"     Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common     symptom whereas life-threatening anaphylaxis is rather rare. A recently published study     (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described     the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients,     disregarding their penicillin skin test results. In the proposed study the investigators will     similarly challenge beta-lactam allergic patients, both children and adults for an extended     (5 days) period of time. The study will include patients with a history of a skin rash     following beta-lactam administration as well as patients who cannot provide any data on their     presumed allergic reaction, disregarding their penicillin skin test results.   "
134819|NCT01520168|"     From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh     was implanted in an estimated 350,000 patients worldwide.      The purpose of the study is to evaluate retrospectively the complications related to this     mesh that occurred in our patients between 2003 and 2005, since new complications continue to     be diagnosed, although the investigators discontinued the use of the mesh.   "
134820|NCT01520155|"     The key of this prospective study is to identify a potentially increased cardiovascular risk     in patients with systemic Lupus erythematodes, with and without renal affection. Three groups     of patients will be compared.   "
134821|NCT01520142|"     The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398     using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.   "
134822|NCT01520129|"     The investigators propose to conduct a 20 week open pilot study of Interpersonal and Social     Rhythm Therapy (IPSRT) to treat individuals (n=18) with subthreshold bipolar (BP) who are     currently depressed. The investigators will conduct a preliminary evaluation of sleep-wake     and social rhythm patterns in study participants using questionnaires and actigraphy. Primary     aims of this study are to evaluate feasibility of this treatment and assessment approach.     Exploratory aims are to examine 1) sleep-wake and social rhythm patterns in subthreshold BP,     2) impact of IPSRT on symptoms and functioning over time and 3) relationship between     sleep-wake and social rhythm patterns and treatment outcomes.   "
134823|NCT01520116|"     This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary     efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or     latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first     portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye     drops for up to 28 days, administered both once and twice daily. In the second portion, up to     180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days.     Plasma pharmacokinetics will also be evaluated during the first portion of the study.   "
134824|NCT01520103|"     The purpose of this study is Examination of the superiority of a combination of vinorelbine     with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in     advanced breast cancer.   "
134825|NCT01520090|"     Starting from Jan 2012 for an interval of 4 months with minimum number of 1200 egyptian women     will be asked to complete a questionairre to evaluate their knowledge of different     contraceptive methods   "
134826|NCT01520077|"     Subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take     vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth.      The investigators hypothesize that Vytorin medication may have an effect on the inflammatory     process of alopecia areata. Inactivating the inflammatory process may help in permitting hair     regrowth in those subjects.   "
134827|NCT01520064|"     -  Obtain and analyze medical record data on patients with advanced emphysema who receive          treatment with the AeriSeal System to better understand safety and effectiveness in the          post-market setting;        -  Provide participating physicians access to specified data sets for the purpose of          generating scientific manuscripts about the effects of AeriSeal System treatment.   "
134828|NCT01520051|"     Asthma is a chronic inflammatory disorder of the airways characterized by lower respiratory     tract (LRT) symptoms such as wheeze, cough and airway obstruction. Patients with asthma     frequently suffer from exacerbations, which can be triggered by allergens and, in particular,     viral respiratory infections. It has recently been shown that mepolizumab, a humanized     monoclonal antibody that neutralizes interleukin(IL)-5, markedly reduces the exacerbation     rate in asthma patients with eosinophilic airway inflammation. Previous studies have     indicated that in a mixed population (eosinophilic and non eosinophilic) of mild asthma     patients, mepolizumab did not have an impact on lung function and asthma symptom scores upon     allergen provocation, although it did on markers such as sputum and blood eosinophils.     Together, these observations led to the hypothesis that mepolizumab treatment reduces the     exacerbation rate by limiting virus-induced asthma exacerbations.      The investigators hypothesize that neutralization of IL-5 during virus infection in patients     with allergic asthma:        1. Reduces virus-induced bronchial inflammation        2. Attenuates virus-induced asthma symptoms, airflow limitation and bronchial          hyperresponsiveness.        3. Enhances cellular immune responses to the virus.      The aims of this study are to:        1. To investigate whether IL-5 neutralization reduces the inflammatory response to viral          airway infections in allergic asthma patients        2. To investigate whether IL-5 neutralization prevents or reduces asthma symptoms during          virus-induced asthma exacerbations        3. To investigate whether IL-5 neutralization affects the cellular immune response to viral          airway infections in allergic asthma patients   "
134829|NCT01520038|"     Invasive urothelial bladder cancer is a common malignancy causing 14,000 deaths annually in     the United States. The primary objective of the feasibility/Phase I portion of the study is     to establish the feasibility and safety of proton and the safety of IMRT for patients with     pure or mixed variant urothelial carcinoma.   "
134830|NCT01520025|"     Coronary artery disease results in narrowing of the blood vessels supplying oxygenated blood     to the heart muscle. Diagnosis in patients with symptoms of chest pain is now quickly done     with CT coronary angiography. This x-ray test can show narrowed blood vessels but has limited     ability to predict the severity of the narrowings in some cases. We have described a new     approach using PET exercise 18F-FDG imaging as a method to image areas of heart muscle not     getting enough blood during exercise stress. The 18F-FDG images are co-registered with the CT     anatomy from the CTA to provide direct evidence of the consequences of the narrowing.   "
134834|NCT01519973|"     Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging technique     that is used extensively to study the heart and diagnose heart disease. There are three major     limitations in SPECT imaging: attenuation or loss of signal, scattering of the signal in the     patient tissues and resolution, where the signal gets blurrier the further the nuclear     activity is away from the camera. New software, Evolution for CardiacTM, by GE Healthcare and     new cameras with computed tomography (CT) decrease the time needed for images to be obtained     while maintaining image quality. Evaluation is needed before they become standard of care.   "
134835|NCT01519960|"     This parallel group, open label study will evaluate the safety and efficacy of Pegasys     (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at     baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and     without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg     subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with     advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment     with Pegasys. Children in the untreated control Group B who have not experienced     seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of     Pegasys treatment. This offer will be available for 1 year following 48 weeks from     randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed     up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.   "
134836|NCT01519947|"     This comparative, open-label, multicenter, parallel-group study will evaluate the effect of     altitude on dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to     achieve a target haemoglobin concentration of 11-12 g/dL in patients with chronic renal     anemia in pre-dialysis and dialysis. Four groups of patients, at sea level or an altitude     above 6'000 feet and in pre-dialysis or dialysis, will receive 50-250 mcg Mircera     subcutaneously according to local label. Anticipated time on study treatment is 36 weeks.   "
134837|NCT01519934|"     Up to 120 subjects within the study site's practice who have already had an Ultherapy™     treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up     visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each     follow-up visit.   "
134838|NCT01519921|"     This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in     patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A     (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180     micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free     follow up.   "
134839|NCT01519908|"     The purpose of this study is to investigate: the relation of a set of (bio)markers and     response to Cardiac Resynchronization Therapy (CRT); the interrelationship as well as the     potential predictive power of these (bio)markers on improvement and/or deterioration of     cardiac function, cardiac geometry (reverse re-modeling during CRT) will be evaluated.      (Bio)markers include but are not limited to: collagen, genomic markers, molecular markers,     electrocardiographic markers, echocardiographic markers, arrhythmogenic markers and markers     for renal function: blood urea nitrogen (BUN), serum creatinine, glomerular filtration rate     (GFR).   "
134840|NCT01519895|"     The purpose of this study is to assess the effectiveness of the telephone intervention     program for caregivers of colorectal cancer.   "
134841|NCT01519882|"     This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the     effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and     night-time movement in bed, in patients with advanced Parkinson's disease.   "
134842|NCT01519869|"     This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant     chemotherapy followed by interval surgical debulking with platinum-based adjuvant     chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable     survival, decreased morbidity, and increased quality of life in patients with International     Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or     fallopian tube cancer when compared to historical controls and to evaluate the hypothesis     that cancer induced inflammation is a predictor of poor prognosis and response to therapy in     this group of ovarian cancer patients.   "
134843|NCT01519856|"     Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of     Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is     unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has     adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from     the literature that the antagonistic properties of piribedil are correlated with an     improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of     the present non-interventional study is to investigate the safety and efficacy of piribedil     during long-term therapy of patients with M. Parkinson under consideration of cognitive     functions and quality of life.   "
134844|NCT01519843|"     Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve     motor learning.      Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying     motor learning in healthy volunteers and in chronic stroke patients.   "
134857|NCT01519674|"     This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical     trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30     (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various     regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or     without other oral anti-diabetic drugs (OADs)).      The trial is conducted as a phase 4 trial in the majority of the participating countries.     However, in some countries the trial is conducted as phase 3b.   "
134860|NCT01519635|"     The goal of this project is to evaluate the chronic effect (8 weeks) of RASILEZ 300mg     (aliskiren) on renal tissue oxygenation in patients with stage 1-2 hypertension, and to     compare the chronic effect (8 weeks) of RASILEZ 300mg (aliskiren) on renal tissue oxygenation     in patients with stage 1-2 hypertension with these effects with those of ESIDREX 25mg     (hydrochlorothiazide).   "
134861|NCT01519622|"     The purpose of this study is to determine the priorities of the elderly in the community     about end-of-life decisions. To check the perception of the disease in the elderly in the     community.   "
134845|NCT01519830|"     Depletion of iron stores is frequently observed in regular blood donors, but effects of iron     deficiency on general health is not well studied. Recent studies in women suffering of     fatigue suggest iron deficiency without concomitant anemia as a common cause of these     complaints. Provided the same is true in healthy subjects, substitution of intravenous iron     might result in an improvement of general well being in iron depleted blood donors.      Healthy regular blood donors will be screened for low storage iron. Qualifying subjects will     be invited to participate in a randomized, placebo-controlled trial with substitution of     intravenous iron or placebo (saline solution). Differences in subjectively felt fatigue and     other factors of general health and well being will be assessed. If an improvement of such     factors can be shown after iron replacement, relevant concerns about artificially lowering     iron stores by repeated phlebotomies will arise and changes of monitoring and substitution     policies in blood banking might have to be discussed.   "
134846|NCT01519817|"     Background:      - Cancer vaccines are being developed to help teach the body's immune system to attack and     destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is     present in some tumor cells, and it can help tumor cells spread to other parts of the body.     Researchers want to see whether the new Brachyury protein vaccine can help treat people with     advanced carcinomas.      Objectives:      - To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in     tumor cells.      Eligibility:        -  Individuals at least 18 years of age who have advanced cancers that have not responded          or are no longer responding to standard treatments.        -  Because the vaccine is made with yeast, people with yeast allergies will not be          eligible.      Design:        -  Participants will be screened with a medical history and physical exam. Imaging studies          will be used to examine the cancer. Heart and thyroid function tests will be conducted.          Blood and urine samples will also be collected.        -  Participants will receive vaccine injections every 2 weeks, for a total of seven visits.          After seven visits, if the cancer has shrunk or stopped growing, participants will          continue to have the vaccine about once a month.        -  Treatment will be monitored with frequent blood tests and imaging studies. Other tests          will be given as directed by the study doctors. Some participants will have apheresis to          collect additional blood cells for study.        -  Participants will continue to receive the vaccine as long the tumor does not start          growing again and there are no serious side effects....   "
134847|NCT01519804|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in     patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC).     Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on     Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and     platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not     progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as     maintenance therapy until disease progression or unacceptable toxicity occurs.   "
134848|NCT01519791|"     This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in     combination with Methotrexate (MTX) for inducing and sustaining clinical response in the     treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active     Rheumatoid Arthritis.   "
134849|NCT01519778|"     Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major     cutaneous abscess or cellulitis/erysipelas.   "
134850|NCT01519765|"     Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue,     is a widely accepted induction agent, that has been proven safe and effective for induction     of labor. It stimulates both cervical ripening and uterine contractions, thus making it an     ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of     different administration routes and effects on uterine contractility, side effects, and     safety. Vaginal misoprostol has been shown to be superior over oral administration however     patients often prefer a more tolerable route. Buccal administration has already been shown to     be as effective as vaginal misoprostol for cervical ripening and induction in both first     trimester and second trimester abortions. There is minimal research comparing buccal versus     vaginal for third trimester induction of labor. The investigators study is a prospective,     double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol     in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal     misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.   "
134851|NCT01519752|"     The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is     effective for the treatment of patients with moderate to severe Tinea pedis.   "
134852|NCT01519739|"     The purpose of this study is to evaluate the safety and performance of the MediGuide™ system     during CRT implants.   "
134853|NCT01519726|"     Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively     and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2     years, and substantial weight loss, oral and i.v. midazolam are administered once more and     blood samples are taken again.   "
134854|NCT01519713|"     This study is designed to assess the safety and immunogenicity of a single dose of     Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine     (SP284) to support registration of the product in Japan.      Primary Objective:        -  To describe the seroprotection rate [% of subjects with serum bactericidal assay using          baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y          and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of          age      Secondary Objectives:        -  To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years          of age        -  To describe the immune responses to meningococcal antigens (serogroups A, C, Y and          W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.   "
134855|NCT01519700|"     The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean     duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast     cancer patients.   "
134856|NCT01519687|"     The purpose of this study is to determine whether levotofisopam is safe and effective in the     treatment of hyperuricemia and gout.   "
134862|NCT01519609|"     Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major     single center has docuemted the advantage of using moviprep as bowel prep before     colonoscopy.This randomised study was conducted to compare moviprep with the present     standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in     patients suspected of colorectal cancer, and to investigate number of days where patients     need to stay home.   "
134863|NCT01519596|"     This is a randomized clinical trial that studies symptom-adapted physical activity     intervention in minimizing physical function decline in older patients with acute myeloid     leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional     impairment and improve the quality of life in patients with AML undergoing chemotherapy.   "
134864|NCT01519583|"     The WalkMore study will help find out how walking interventions can help overweight/obese     postmenopausal women with increased risk of cardiovascular disease lower their blood     pressure.   "
134865|NCT01519570|"     Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain     low. Electronic medical records (EMR) can serve as a practical strategy to better facilitate     the application of preventative health care, such as increasing immunization rates. A new     care model that can increase the herpes zoster vaccination rate, as well as other     preventative health services, is warranted. The objective of this study is to investigate if     the functions of an EMR, in combination with a pharmacist as part of the care team, can     improve the herpes zoster vaccination rate.   "
134866|NCT01519557|"     The investigators propose to recruit individuals with schizophrenia who are symptomatically     stable and already taking medications to participate in this study. The investigators will     recruit 90 individuals with schizophrenia and randomize them to low and high doses of     DAR-0100A, as well as to placebo. The investigators will have them stay in the hospital for     several weeks and receive up to 10 doses of DAR-0100A. The investigators will also test their     cognition before and after receiving DAR-0100A to see if DAR-0100A is helpful and perform MRI     scans before and after taking the medication to see which areas of the brain are activated     when DAR-0100A is administered. These tests will be very important because they will help the     investigators determine whether the D1 receptor is a good treatment target for schizophrenia     and whether more research and resources should be devoted to finding medications that target     this system.      Patients with schizophrenia will be free of other medical, psychiatric and neurological     disorders including alcohol and substance dependence, and will be able to understand the     nature of the study and to provide informed consent.   "
134867|NCT01519544|"     More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to     answer the question: Which medication is associated with better sleep at high altitude:     temazepam or acetazolamide? The investigators hypothesis is that one medication will be     associated with higher subjective sleep scores than the other. The study will compare the     sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit     to high altitude.   "
134868|NCT01519531|"     This is a single-center, randomized, double-blind, placebo-controlled, ascending     multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics     of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to     escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days.   "
134869|NCT01519518|"     The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the     performance and subsequent outcomes of Primary percutaneous coronary intervention. This will     be a pragmatic trial. Interventional procedures will be performed to reflect current and     evolving standards, including predominant radial access. All patients will be treated with     routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for     'bail out' treatment only.   "
134870|NCT01519505|"     Public health strategy on type2 diabetes prevention in primary health care. European     coordinated project (DE-PLAN) adapted to Catalonia (DE-PLAN-CAT). Two-step multicentre cohort     study: cross-over period (screening) plus a follow-up period (preventive intervention): 12     centres, 7 working-groups, 42 units, 106 professionals). Interventions: Randomized     non-invasive diabetes screening program by means of the FINDRISC score comparing with the     oral glucose tolerance test results. At least one third of the screened subjects is expected     to present high-risk criteria. They will choose 1 out of 3 interventions to modify lifestyle:     self-acting vs. individualized or group-based educative (6-hour, 3 or 4 sessions program).     Participants' motivation will be periodically reinforced. Follow-up will be focused on     diabetes incidence, cardiovascular risk (HearthScore, Regicor scores), lifestyle-quality of     life (assessed by European peer-reviewed questionnaires) and cost-effectiveness analysis.     First-year results includes: protocol, measurement tools and database available, screening     concluded (n=2082) and European intervention manual on type 2 diabetes prevention started.   "
134871|NCT01519492|"     The purpose of the study is to determine the safety, tolerability and effectiveness of     AFN-12520000 for in the treatment of Staphylococcal infections of the skin.   "
134872|NCT01519479|"     The purpose of this study is to assess the impact of palliative care consultation on quality     of life and symptom management for patients hospitalized with acute heart failure with a     randomized control trial at Abbott Northwestern Hospital.   "
134873|NCT01519466|"     The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood     glucose meter with a built-in insulin calculator) on glucose control in people with type 1     diabetes.   "
134907|NCT01519024|"     Principles of motor control suggest that breast hypertrophy can lead to sensoriomotor     alterations and impairment in body balance due to postural misalignment. The investigators     conducted this study to evaluate the postural control with different sensorial information     condition in women with breast hypertrophy.   "
134884|NCT01519323|"     This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail     extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy     of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly     diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma     harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until     disease progression or unacceptable toxicity occurs.   "
134874|NCT01519453|"     Low-income, minority children are disproportionately affected by asthma and can experience     higher rates of asthma attacks, lower lung function, decreased physical activity, increases     in school absenteeism, and higher rates of death. The National Center for Children in Poverty     suggests that effective interventions to improve asthma and reduce harm for high risk groups     (like low-income minority children) must begin in early childhood. Previous research has     shown that asthma education programs can be effective to improve overall asthma management in     preschool children, but there has been limited sustainability of these programs in medical,     educational, and social environments that serve young high risk children. One of the core     missions of federally-funded Head Start programs is to provide preventive health services and     screening to their low-income preschool students and would be an ideal setting in the     community to disseminate an early asthma education program. The purpose of this study is to     draw on our health and research partnership with Baltimore City Head Start programs to test     the effectiveness of a home-based asthma education intervention combined with a Head Start     level asthma education program compared to a Head Start level asthma education program alone.   "
134875|NCT01519440|"     The purpose of this study is to determine whether a specific surgical technique, blunt     compared with sharp expansion of the transverse lower uterine incision, is associated with     risk of unintended extension of uterine incision   "
134876|NCT01519427|"     This phase II trial studies how well selumetinib and Akt inhibitor MK2206 works in treating     patients with stage III or stage IV melanoma who failed prior therapy with vemurafenib or     dabrafenib. Selumetinib and Akt inhibitor MK2206 stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. It is not yet know whether giving selumetinib and     Akt inhibitor MK2206 together is an effective treatment for advanced melanoma.   "
134877|NCT01519414|"     This randomized phase II trial studies how well tivantinib works compared to placebo in     treating patients with metastatic prostate cancer. Tivantinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth.   "
134878|NCT01519401|"     The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the     metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).      The objective of this study is to compare the effects of a long term administration of two EP     combinations, containing the same progestin (3 mg drospirenone) and a different dose of     ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in     normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group     A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score     evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp     and lipid profile were performed at baseline and after 6 and 12 months of therapy.   "
134879|NCT01519388|"     Neuromuscular disorders can be associated with swallowing dysfunction secondary to a     dysfunction of the airway muscles involved in swallowing. The investigators have shown that     respiratory failure may contribute to swallowing dysfunction in patients with neuromuscular     respiratory failure. Furthermore, although tracheostomy has been reported as impairing     swallowing, the investigators have shown that when a tracheostomy is performed in     neuromuscular patients, swallowing improves because it allows the patient to feed while     ventilated.      The investigators now want to evaluate whether non invasive ventilation may have a beneficial     impact on swallowing by making some adjustments to ensure a good synchronisation between     ventilation and swallowing. This could allow avoiding the necessity of a tracheostomy or a     gastrostomy due to swallowing dysfunction and/or malnutrition in neuromuscular patients.      Swallowing improvement under mechanical ventilation depends on improving the synchronisation     between the patient and the ventilator during swallowing. For that purpose, the investigators     developed a prototype ventilator able to temporarily suspend pressurisation under the     patient's control so that when the patient needs to swallow under mechanical ventilation he     may do so with an inadequate insufflation of the ventilator.      Our objective is to to demonstrate that swallowing is more adapted and easier under nasal     noninvasive ventilation than during spontaneous breathing in neuromuscular patients requiring     prolonged noninvasive ventilation.      In an open monocentric pilot study, the investigators will study 10 neuromuscular patients     usually noninvasively ventilated. The patients will be their own control and their swallow     will be studied during spontaneous breathing and under ventilation with the adapted     ventilator while swallowing boluses of different volumes.   "
134880|NCT01519375|"     The primary objective of this cross-sectional observational real life study is to investigate     the patient reported adherence to PPI, when prescribed as prevention of NSAID associated GI     Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis, Rheumatoid     Arthritis or Ankylosing Spondylitis. Adherence will be assessed by patient questionnaires.   "
134881|NCT01519362|"     Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue     augmentation in different parts of the body , such as face, breast , or even penis for more     than a decade . However, there are never reports about the application of a large amount of     PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with     leukocytopenia. This fancy application turned out to be a disaster for the women who suffered     from leukocytopenia , widespread migration of PAAG, recurrent swelling of the affected     tissues and temporal pain changing with the temperature and the facial expression .   "
134882|NCT01519349|"     The investigators are performing a gene therapy clinical trial in Becker muscular dystrophy     (BMD) and sporadic inclusion body myositis (sIBM) patients. Both of these conditions have an     important common feature: loss of ability to walk because of weakness of the thigh muscles.     The investigators plan to do a gene therapy trial to deliver a gene to muscle called     follistatin (FS344) that can build muscle size and strength. If successful, the investigators     can increase the size of the thigh muscle and potentially prolong a patient's ability to     walk. The gene will be carried into the muscle by a virus called adeno-associated virus     (AAV). This virus occurs naturally in muscle and does not cause any human disease, setting     the stage for its safe use in a clinical trial.      Presently there is no treatment that can reverse Becker muscular dystrophy or sporadic     inclusion body myositis. Only supportive care is currently possible.      In this study, subjects with either of these diseases will have shots of the follistatin gene     injected directly into thigh muscle on one (first cohort) or both legs (2nd and 3rd cohort).     One hundred and eighty days following the gene delivery, the muscle will undergo biopsy to     look closely at the muscle to see if the muscle fibers are bigger. Between the time of the     gene transfer and the muscle biopsy, patients will be carefully monitored for any side     effects of the treatment. This will include an MRI of the thigh muscle before treatment and     at day 180 following treatment. Blood and urine tests, as well as physical examination will     be done on the subjects during the screening visit and on days 0, 1, 2, 7, 14, 30, 60, 90,     and 180 to make sure that there are no side effects from the gene injections. Sutures will be     removed 2 weeks post-biopsy.      Additional blood samples will be collected at 9, 12, 18, and 24 months. Patients will be seen     at the end of 1st and 2nd years for a physical exam, assessment of muscle strength and     appropriate blood tests.   "
134883|NCT01519336|"     This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential     drug-drug interactions between darunavir and danoprevir when administered together with     low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive     either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all     subjects will receive darunavir plus danoprevir together with ritonavir for 10 days.     Anticipated time on study treatment is 20 days.   "
134885|NCT01519310|"     The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism     (a form of choline monitored in this study is called phosphatidylcholine, also known as     lecithin). This study will help to determine if choline metabolism is affected by short-term     antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating     yogurt).   "
134886|NCT01519297|"     This study will compare blood vessel and hormone differences between women who have a history     of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a     history of uncomplicated pregnancy in the last 10 years. The investigators hypothesize that     postpartum women with history of preeclampsia will have altered blood vessel function and     abnormal hormone levels compared with postpartum women with history of uncomplicated     pregnancy.      This study will take place over the course of 2 weeks. Each subject will be assessed on a     fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood     vessel imaging tests and fasting blood draws.   "
134887|NCT01519284|"     To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics,     in comparison to placebo and entacapone.   "
134888|NCT01519271|"     Mild cognitive impairment, including difficulty with solving problems, planning, attention,     or recalling information, can be a significant problem for individuals with Parkinson's     disease. Even mild cognitive difficulties can lead to worse functioning, quality of life,     depression, and difficulty for caregivers. Thus, ideally treatment at this stage would     improve both cognitive symptoms and some of the other problems associated with these     symptoms.      Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease     patients little is known about how best to treat it. This study is a 24-week clinical trial     to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine)     Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease.     Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to     moderate dementia in Alzheimer and Parkinson's disease patients.   "
134889|NCT01519258|"     Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical     activity of the diaphragm to control the mechanical ventilator, offering inspiratory     assistance in proportion to respiratory effort to patients who need artificial ventilatory     support. It has been shown to improve the interaction between the patient and the mechanical     ventilator in several clinical situations, but no previous studies have tried to use it for     patients with a severe type of respiratory insufficiency, called Acute Respiratory Distress     Syndrome (ARDS). Patients with ARDS benefit form a mechanical ventilatory strategy that     includes low inspiratory volumes (tidal volumes) and limited airway pressures, but the     application of such strategy frequently requires high levels of sedation. The investigators'     hypothesis is that NAVA can be used for patients with ARDS, and that it will not be     associated with excessive tidal volumes or elevated airway pressures.   "
134890|NCT01519245|"     The goal of this project is to determine whether the use of tranexamic acid, a clot-promoting     drug, applied topically over the heart in coronary artery bypass graft surgery (CABG) will     reduce post operative blood loss. The investigators' hypothesis is that the use of a     tranexamic acid-containing cardiac bath prior to chest closure will result in a statistically     significant reduction in blood loss and transfusion requirements in patients who undergo     CABG.   "
134891|NCT01519232|"     Radiation-induced liver disease (RILD) is a syndrome characterized by the development of     anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous     studies have shown that both the volume of liver irradiated and the dose of radiation     delivered are prominent factors for development of RILD. While use of a population-based     normal tissue complication probability model allows investigators to limit the risk of RILD     to a clinically acceptable level, a test that permits investigators to determine an     individual's risk of RILD during the course of treatment may allow for individualized     treatment modifications, either to prevent toxicity or increase efficacy.   "
134892|NCT01519219|"     The goal of the trial is to assess the effect of radiation treatment on liver function as     determined by indocyanine green extraction. The long term goal is to determine if individual     assessment of liver function using the IC-Green method, either alone or in combination with     other factors, will provide Radiation Induced Liver Disease (RILD) risk-estimates that are     superior to the probabilistic method currently in use.   "
134893|NCT01519206|"     The purpose of this study is to evaluate the Ulthera® System for obtaining lift and     tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or     submental skin laxity when increased density treatment is applied.   "
134894|NCT01519193|"     Street children and children of vulnerable families in conflict or former conflict regions     are often exposed to multiple traumatic events and situations in which they are forced to     engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims     to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful     experiences and positive emotions linked to violent behaviour in the past. Additionally,     visions for the future are developed in order to foster successful reintegration into     society.   "
134895|NCT01519180|"     Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even     nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal     motility impairement.   "
134896|NCT01519167|"     The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric     population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS)     for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.   "
134908|NCT01519011|"     The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine     when administered once daily as two 150-mg tablets, including the effect of food, and to     evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg     tablets relative to three 100-mg tablets.   "
135029|NCT01517412|"     Primary Objective:      - To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c)     from baseline to endpoint (Week 24)      Secondary Objective:        -  To assess the effect of the 2 lixisenatide regimens on:             -  The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at               Week 24             -  Fasting Plasma Glucose (FPG)             -  7-point Self-Monitored Plasma Glucose (SMPG) profiles             -  Body weight        -  To assess the safety and tolerability of the 2 lixisenatide regimens   "
134897|NCT01519154|"     Children < 10 years of age often need deep sedation or anaesthesia to allow elective     diagnostic magnetic resonance imaging; standard routine protocols are        1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs          and propofol infusion 10 mg/kg h        2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed)          and propofol infusion 5 mg / kg h      both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI,     cerebral perfusion/blood flow.      Hypothesis:        1. reduces recovery time compared to propofol mono sedation        2. combination of ketamine-propofol increases incidence of Postoperative nausea and          vomiting (PONV) compared to propofol mono sedation        3. combination of ketamine-propofol increases global cerebral blood flow and changes          regional distribution of cerebral perfusion compared to propofol mono sedation   "
134898|NCT01519141|"     This is a longitudinal observational study of HIV-infected patients and HIV-negative control     patients that is being conducted to learn more about immunologic factors, inflammation, and     cardiovascular risk in patients with HIV infection or in patients with autoimmune disease.     The investigators plan to obtain measurement of carotid artery intima media thickness (IMT)     using high resolution ultrasound as a noninvasive means for tracking atherosclerotic     progression. The investigators will also measure lipid and lipoprotein levels, inflammatory     markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic     lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly     collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell     turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count     and HIV viral load measured in addition. Patients will undergo detailed clinical history     including HIV disease, specific HIV medications, comorbid conditions, and health related     behaviors. Physical exam and measurements will be obtained to assess for the presence of     lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview     at 4-12 month intervals for the next 3 years.      Patients will also go assessment of endothelial function, endothelial progenitor cells,     arterial stiffness as measured using pulse wave tonometry.      To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV     positive and negative patients with cardiac disease, the investigators will use 48-hour     Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of     myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery     hypertension for the presence of cardiac arrhythmia.      The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography)     will be used to detect and quantify inflammation in the body.   "
134899|NCT01519128|"     The purpose of this study is to investigate the effect of steady-state (constant     concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what     the body does to the medication) of digoxin.   "
134900|NCT01519115|"     Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization     has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training     cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to     be effective in reducing neck pain, restoring cervical spinal function and mobility in many     types of cervical spine dysfunction. However, the training of stabilizers has not been     studied in individuals undergoing cervical spinal surgery, even though these individuals     often have problems with residual pain and weakness after the surgery.      Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes     between an early PT intervention and usual care in patients who have undergone anterior     cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved     with early PT intervention.      Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3)     research design. The patients following ACF surgery will be randomly assigned in one of the     two treatment groups: usual care and early intervention. Three outcome measures will be     collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up     visits, including: (1) deep cervical flexor (DCF) strength as determined by the     cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated     neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain     level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks, the global     rate of change (GROC) scale will be obtained to determine the patient's perception of overall     improvement as a result of surgery. The investigator performing the outcome measures will be     blinded to group assignment, and therefore will not participate in treatment. After     randomization, the usual care group will receive only one visit of PT for post-operative     instruction. The early intervention group will receive verbal and written instructions for     posture and training cervical spine stabilizers in addition to the usual care. The early     intervention group also will be asked to perform these exercises at home and keep a log of     the exercise.      Data Analysis: Two 2x3 MANOVAs with repeated measures will be used to examine the differences     in the CCF strength and the NDI scores between groups and at the three different time frames     with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to     compare the differences in the NPRS and GROC data over time and between groups.   "
134901|NCT01519102|"     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required     insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would     regulate glucose levels through the infusion of two hormones: insulin and glucagon.      The main goal of this project is to assess whether a dual-hormone closed-loop strategy would     alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D)     without a significant degradation in post-meal glucose control.      Each patient will be admitted twice to a clinical research facility. In one visit, patients     will eat a morning meal accompanied with a matching insulin bolus (depending on the     carbohydrate content of the meal) and glucose levels will be subsequently regulated using     dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will     inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and     the remaining needed insulin will be delivered based on glucose sensor excursions as part of     closed-loop operation. If post-meal glucose levels were indifferent between the two visits,     then this would suggest that carbohydrate counting may not be necessary during closed-loop     operation as the closed-loop system will give any remaining insulin needed to cover the     glucose absorbed from the meal. Twelve subjects will be enrolled in this study.   "
134902|NCT01519089|"     The main objective of this study is to evaluate the long term safety of CP-690,550 in     patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis.     This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10     mg BID) after 16 weeks of treatment.   "
134903|NCT01519076|"     This study is a prospective trial wherein each included subject will receive the experimental     magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male     or female patients who meet the inclusion and exclusion criteria and informed consent has     been obtained. Subjects presenting in the emergency department with acute ischemic stroke and     are eligible for tPA therapy may be considered for inclusion in the study.   "
134904|NCT01519063|"     The purpose of this study is to evaluate the combined effects of the study medications     naltrexone and memantine on alcohol drinking behaviors. Participants will be randomized to     receive a combination of these medications over a one week period and then participate in a     laboratory session. During this session, participants are given an initial drink of alcohol     followed by the choice to drink up to 12 more drinks over a three-hour period. These     medications are hypothesized to reduce craving and number of drinks consumed prior to and     after exposure to the initial drink of alcohol and during the three hour drinking period.   "
134909|NCT01518998|"     The purpose of this study is to evaluate the antihypertensive efficacy and safety of     Fimasartan   "
134912|NCT01518959|"     Recent data have shown that the inadequate vitamin D status plays a role in the manifestation     of the haematologic tumors and serum vitamin D level has a prognostic role also as it     determines the tumor mortality. But data have not proved a causal relationship between the     inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown,     whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to     improve the prognosis and survival.      In this study the investigators examine the role of the adequate vitamin D substitution in     the improvement of the outcomes of haematologic disorders.   "
134913|NCT01518946|"     The purpose of this study is to determine whether midodrine works against the symptoms of     orthostatic hypotension caused by being on a tilt table.   "
134914|NCT01518933|"     Hepatitis C virus (HCV)-related liver disease is the most common indication for liver     transplantation (LT). However, LT does not cure the infection, and therapeutic strategies     resulted in very limited efficacy and tolerability in LT recipients. In view of its     postulated safety profile, Silibinin seems an ideal drug to be used in the setting of HCV     recurrent patients after liver transplantation.   "
134915|NCT01518920|"     The objective of this study is to examine the safety, tolerability, and effects on hearing     thresholds of two single doses of PF-04958242 and placebo in subjects with age-related     hearing loss.   "
134916|NCT01518907|"     This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of     AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.   "
134917|NCT01518894|"     To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242     administered orally to psychiatrically stable subjects with schizophrenia receiving     antipsychotic and adjunctive medication.   "
134918|NCT01518881|"     This is a phase 1, single-center, placebo-controlled, single-blind, first-in-human,     single-ascending dose study with additional multiple-ascending dose cohorts in healthy male     and female volunteers.   "
134919|NCT01518855|"     The primary objective of this study is to investigate incremental cost effectiveness of     Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of     essential hypertensive patients.      To investigate incremental cost effectiveness, primary variables are mean treatment cost and     achievement rate to target blood pressure level at the end of double-blind treatment period.   "
134920|NCT01518842|"     This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem     cells in patients with ischemic retinopathy.   "
134921|NCT01518829|"     the value of serum procalcitonin in differentiation between bacterial infection and non     infectious inflammation in febrile HCC patients following locoeregional treatment for HCC.   "
134922|NCT01518816|"     The aim of this study is to detect the association between maternal serum antioxidant level     and preterm labor.   "
134923|NCT01518803|"     Obesity has a major impact on the development of cardiovascular disease and other related     conditions and it is of particular concern in children. The prevalence of childhood     overweight and obesity in Spain is among the highest in the European continent. Childhood     obesity has been associated with diseases that were thought to apply only to adults, such as     the metabolic syndrome. Insulin resistance is the most important risk factor in subjects with     severe obesity, which together with visceral obesity, exacerbates postprandial     triglyceridemia, increasing cardiovascular risk.      In this context, the investigators hypothesize that the postprandial lipid metabolism is also     impaired in obese pre-adolescents, as it is in obese adults. This includes not only     exacerbated postprandial triglyceridemia, but also impaired levels of inflammation markers.     In addition, the investigators hypothesize that the lipid and protein composition of     postprandial chylomicrons and chylomicron remnants are also altered in obese children when     compared with their normal-weight counterparts, and that these postprandial lipoproteins     induce foam cell formation differently. The investigators also believe that a     Mediterranean-style meal can help to normalize the altered postprandial lipid metabolism in     obese adolescents.   "
134924|NCT01518790|"     The investigators propose to conduct a prospective study of a widely used bowel preparation     regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a     colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep     2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the     cleanout, assess tolerability and acceptance of the regimen, determine an appropriate     duration to complete the regimen and assess for any electrolyte changes or side effects.   "
134925|NCT01518777|"     This is a pilot study to see whether cardiac imaging can be performed using half the standard     dose of radioisotope.   "
134926|NCT01518764|"     Rationale:      Epidemiological studies have shown that consumption of alcoholic beverages, red wine in     particular, is associated with less cardiovascular mortality. In addition, there are reported     beneficial effects of red wine on components of the metabolic syndrome, arguably the most     menacing cardiometabolic condition facing us due to the unfolding obesity epidemic.     Beneficial effects have also been reported with other polyphenol-rich food stuff, such as     cocoa and green tea and points to a beneficial effect which does not seem to be dependent on     the alcohol content of red wine. Experimental studies with mixed or separate Red Wine     Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic     parameters associated with obesity. Most research has focused on resveratrol, a specific     polyphenol components which is quite specific to red wine and has, at least in animal     studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial     function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the     same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce      Objective:      To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function     (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.      Study design:      Randomized controlled trial (double blind).      Study population:      Obese (BMI >30); n=30, men or women, aged 18-60 years.      Intervention:      Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.   "
134990|NCT01517919|"     This study will systematically evaluate a training program in state-of-the-art behavioral     change approaches and facilitation skills for peer leaders and a peer-led diabetes     self-management support program designed to be conducted in community and clinic-based     settings on an ongoing basis.   "
134927|NCT01518751|"     Symptoms of blood pressure dysregulation, impaired swallowing and digestion are common     amongst parkinson patients. The overall aim of this study is to examine blood pressure     regulation and esophageal motility and gastric emptying in Parkinson`s disease (PD) patients.      The investigators hypothesize that - compared to age-matched controls - PD patients display     an altered regulation of blood pressure, altered gastroesophageal motility, and delayed     gastric emptying. These symptoms occur already early in the disease process, but aggravate     with progression of the disease.      The investigators will perform a 7-day blood pressure measurement, measurement of central     blood pressure and pulse wave velocity, assessment of pulse variability, Schellong tests to     assess orthostatic function, high resolution manometry assessments during swallowing acts,     and a 13C-sodium octanoate breath test to assess gastric emptying, in 18 PD patients (9 each     Hoehn&Yahr stages 1,2) and 12 age- and gender-matched healthy controls. Results will be     interpreted in relation to the severity of PD motor symptoms.      The investigators anticipate that blood pressure dysregulation and gastroesophageal motility     disturbances will be present only in PD subjects, but not in matched controls without     neurological disorders and without any extrapyramidal motor signs. Furthermore, the     investigators expect to find an association between motor impairment and the severity of     these autonomic symptoms, however, that according to the Braak staging, subtle disturbances     must already be present in the early stages of PD.   "
134928|NCT01518738|"     The purpose of this study is to understand whether attention training is effective in     moderating mind wandering.   "
134929|NCT01518725|"     The purpose of this study is to evaluate the change in vitamin D status with the change in     muscular strength and muscular power in highly trained athletes over a 9-month study period.     The investigators hypothesize that the greatest muscular strength and power gains will be     demonstrated in the athletes who achieve and maintain a 25(OH)-D > 50 ng/mL (but < 100 ng/mL)     over the 6 month study duration.      This hypothesis will be tested by carrying out the following specific aims: Aim 1. to     determine the extent to which increasing serum 25(OH)D to > 50 ng/mL is associated with     improved muscular power by assessing specific performance measures (e.g. Vertical Jump Test     and Wingate test) relative to lean body mass; and Aim 2. to examine the correlation between     vitamin D status and muscular power over time.   "
134930|NCT01518712|"     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)     tablets of canagliflozin and metformin immediate release (IR) in comparison with the     individual components of canagliflozin and metformin IR.   "
134931|NCT01518699|"     The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in     Healthy Volunteers.   "
134932|NCT01518686|"     The purpose of this study is to determine normal values of the visual field (VF), corrected     for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic     perimetry (SKP).   "
134933|NCT01518673|"     Patients undergoing a computed tomography are exposed to a relatively high dose of X-rays.     Pediatric patients are known to be very radiosensitive with respect to radiation induced     cancer. Using the technique of scoring γ-H2AX foci in peripheral blood lymphocytes the most     important lesions to the genetic material DNA, double strand breaks induced by CT X-rays can     be detected. The technique will be applied in a multicenter setting for evaluation of     X-effects induced by a computed tomography examination in a population of pediatric patients.     To this end a blood sample will be taken from the patients before and after the examination.   "
134934|NCT01518660|"     The purpose of this study is to investigate underlying mechanisms possibly explaining the     beneficial effects of progressive resistance training for people with multiple sclerosis.   "
134935|NCT01518647|"     The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in     patients with long lasting health problems with no known medical explanation, defined as     multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of     treatment, a 9-session group therapy and a 1-day workshop followed by an individual     consultation, and both are compared to standard treatment, which is one single advisory     consultation. The study includes 180 patients.   "
134936|NCT01518634|"     The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in     patients with longlasting health problems with no known medical explanation, defined as     multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS     have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing     both pain and other symptoms of bodily distress for patients with BDS. Control conditions are     pill placebo. Study duration is 19 weeks for each of the 140 patients. End point is 13 weeks,     i.e. after 10 weeks of 25-75 mg study drug.   "
134937|NCT01518621|"     To determine if erlotinib given orally along with concurrent whole brain irradiation in lung     cancer patients with brain metastases improves median overall survival and enhances local     control compared to those treated with WBRT alone, without significantly increasing the risk     of side effects or lowering quality of life.   "
134938|NCT01518608|"     Induction of anesthesia:      After 3 minutes pre-oxygenation with 100% oxygen, a blinded dose alfentanil (0,10,20,30,40,50     or 60 µg/kg, followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will be administered     over 15 sec. Laryngoscopy will be performed 40 s. after injection of rocuronium, with the     goal being to have the endotracheal tube passed through the patients vocal cords and the cuff     inflated within the following 15 s . The investigator performing the tracheal intubation is     blinded to the dose of alfentanil administered.      Blood samples:      As part of the study efficacy, blood samples, will be collected prior to induction and 30 s.,     1 min. 3 min. and 5 min postintubation to determine blood concentrations of alfentanil and     catecholamines.   "
134950|NCT01518452|"     The main aim of this prospective interventional study is to compare quantitative EEG findings     and cognitive and neuropsychological test results before and after training with the Cogmed     JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6     years. The investigators hypothesize that the children in the study may respond positively to     the computerized training and improve working memory, but probably to different degrees     depending on the underlying neurological condition. The investigators also hypothesize that     training may benefit additional executive functions.   "
135012|NCT01517633|"     The purpose of this study is to compare the reliability and validity of a new device with     standard methods for diagnosing between amniotic fluid leakage due to premature rupture of     the membranes (PROM) and urine.   "
134939|NCT01518595|"     The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is     the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with     hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of     cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to     date, the only therapeutic option is liver transplantation. The study hypothesis is that     administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary     syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS     according to the ERS task force criteria will be included in this block randomized,     double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with     placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8     weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary     endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration     of the study is 2 years.   "
134940|NCT01518582|"     This is a prospective clinical study to assess the performance of the prosthesis according to     a composite success criterion. The clinical and functional results and the patient's quality     of life up to 24 months of follow-up will also be recorded.      Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.   "
134941|NCT01518569|"     The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin     inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response     in cardiac surgery with CPB.      Serial measurements and analysis of several inflammatory cytokines (bactericidal permeability     increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac     injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's     efficacy.   "
134942|NCT01518556|"     The purpose of this study is to determine whether idarubicin dose intensification is safe and     effective as a remission induction therapy for acute myeloid leukemia.   "
134943|NCT01518543|"     There are many ways of performing arthrodesis in the foot and ankle. Dowel fusion is one of     them.      The in situ technique was first described by Ottolenghi et al. (1970) and was taken up by     Baciu and Filibiu (1979). In the technique, they did take the dowel out before turning it.     The healing process takes place between surfaces of spongious bone. They showed excellent     results with early weight bearing and healing within 12.5 weeks. Stranks et al. (1994)     combined the dowel technique with screw fixation and claimed 95 % healing rate within 12.5     weeks. Others have not found this technique satisfactory in rheumatoid arthritis patients     (Belt et al. 2001). The results were not compatible to common fusion techniques. The reason     may be the circular bone gap of at least 1 mm left by the saw blade.      A new instrumentation and a new staple with a central wedge (ASTUS) avoid this gap and allow     the dowel to be turned in situ without leaving in position. The staple is introduced into the     joint line and will compress the dowel surfaces against the surrounding bone. Instruments are     available to ensure the correct position and length of the dowel, and to rotate it in situ     before the special wedge staple is introduced.      Dr Kofoed, the surgeon designer of the ASTUS Staple, has communicated on his first series     with 83 arthrodesis. The purpose of this study is now to collect and publish data from     several centers, several users.      The objective of this study is to obtain the percentage of healing 3 months after an     implantation of the staple ASTUS.   "
134944|NCT01518530|"     The study is intended to examine the safety and efficacy of computerized mobilization of the     neck for the treatment of patients with chronic neck pain. This is a third continuation study     aimed at examining the Occiflex Robotic System. This time we will be studying tailored or     personalized three dimensional movement of the neck.   "
134945|NCT01518517|"     Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by     toxicities including hypersensitivity. Clinical allergy is associated with inactivation of     asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any     clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics,     tolerability and maintain circulating asparaginase activity due to the protective barrier of     the erythrocyte membrane.      This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination     with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without     known hypersensitivity to L-asparaginase.   "
134946|NCT01518504|"     The purpose of this study is to investigate the effect of thoracic spine joint manipulation     versus a sham intervention on active and passive shoulder flexion (elevation), external     rotation, and internal rotation range of motion.   "
134947|NCT01518491|"     The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with     serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and     soft tissue wounds when compared to a serial wound debridement and irrigation alone in     patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with     reticulated open cell foam (ROCF) dressings.   "
134948|NCT01518478|"     A new flu vaccine which is injected into the skin instead of into the muscle has recently     been approved by the Food and Drug Administration for vaccination of the general population     including patients with atopic dermatitis (AD). This new vaccine has been shown to work as     well as the vaccine which is injected into muscle when tested in people without atopic     dermatitis. The primary endpoint of the study is to estimate the variance of the log fold     change from baseline in HAI antibody titers for non-atopic controls and participants with     atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of     a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.   "
134949|NCT01518465|"     This randomized pilot phase II trial studies how well giving dalteparin, lenalidomide, and     low-dose dexamethasone together works in treating patients with previously untreated multiple     myeloma. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in     patients being treated with lenalidomide and dexamethasone for multiple myeloma. Biological     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop     cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving dalteparin, lenalidomide, and dexamethasone together may be an     effective treatment for multiple myeloma   "
134951|NCT01518439|"     Inefficient cough is responsible of respiratory complications in neuromuscular patients which     can lead to hospitalisation and can be life threatening. Techniques enhancing cough     efficiency are successful in improving the clearance of bronchial secretions and help non     invasive ventilation efficiency especially in case of acute respiratory failure. Combining     mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency.     Therefore the investigators want to compare cough efficiency under different techniques of     instrumental and manual of cough assistance in order to determine the best combination to     optimize cough flow.   "
134952|NCT01518426|"     The purpose of this study is to compare three different techniques of EEG recording for     extraction of P300 Evoked Related Potentials (ERPs).   "
134953|NCT01518413|"     The purpose of this study is to determine the safest and most effective oral dose     combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e.     relapsed or refractory.   "
134954|NCT01518400|"     The purpose of this study is to develop a mechanism for utilizing the comprehensive clinical     database of childhood cancer survivors at Childrens Hospital Los Angeles (CHLA) for research     purposes. Using clinical information obtained from follow-up visits of childhood cancer     survivors, the database will focus on interventions to improve health status and     health-related quality of life in childhood cancer survivors. This study allows for     establishment and analyses of a research database for LIFE survivors by the investigators     listed herein. Over the last three decades, there has been marked improvement in survival     following childhood cancer, with 5-year survival rates now approaching 80%. However, the use     of cancer therapy at an early age can result in complications that may not be apparent until     years later as the child matures. These resulting complications, called late effects, are     principally related to the specific therapy employed and the age of the child at the time the     therapy was administered. Late effects may affect virtually every body system and     substantially impair quality of life. As many as two-thirds of childhood cancer survivors     develop at least one late effect as a result of treatment, and approximately one-third have a     late effect classified as severe or life threatening.   "
134955|NCT01518387|"     The purpose of this study is to assess the effect on reduction of serum phosphate and the     safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing     continuous ambulatory peritoneal dialysis.   "
134956|NCT01518374|"     This protocol is designed to standardize imaging studies using florbetapir F 18 PET to     provide information on amyloid burden in subjects participating in other studies (companion     protocol) such as longitudinal studies of aging and studies of biomarkers for     neurodegenerative diseases.   "
134957|NCT01518348|"     To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E.     Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin,     Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric     subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical     history.   "
134958|NCT01518335|"     This research study hopes to determine whether or not platelet rich plasma therapy improves     healing time of moderate to severe ankle sprain in comparison to standard of care therapy.   "
134959|NCT01518322|"     Overall Aim:      To better understand the diagnostic process for prolonged respiratory events and determine     the potential role of FeNO in assessing the possibility of asthma as the symptoms etiology.      Study Objectives:      The specific objectives of this study are to:        -  Determine the frequency of ICS prescription for the treatment of non-specific lower          respiratory symptoms.        -  Determine the frequency of asthma diagnosis as an etiology for the non-specific lower          respiratory symptoms.        -  Explore the value of FeNO in identifying asthma as the etiology of the non-specific          lower respiratory symptoms.      Number of Subjects:      It is anticipated that up to approximately 3,000 patients will be asked to complete the brief     screening questionnaire that will be used to identify up to approximately 280 eligible     patients who meet the study inclusion/exclusion criteria during a (approximately) 4 to 6 week     study enrollment period.      Reference Product: NIOX MINO®      Duration of the participants involvement in the investigation: Single Visit      Performance assessments:      Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed using the NIOX MINO®     device according to Instructions for NO measurements which will be provided to each     Investigative site prior to patient enrollment.      Safety Assessments:      The Investigator is responsible for the detection, reporting, and documentation of events     meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this     clinical investigation plan from the time of informed consent/assent and during the study     period.      Criteria for Evaluation:      The relationship(s) between FeNO and both the diagnosis of asthma and prescription of ICS     will be explored by correlation, measures of concordance and logistic modeling.   "
134960|NCT01518309|"     This is an open-label extension study to assess the long-term safety and tolerability of     pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).   "
134961|NCT01518296|"     Pelvic organ prolapse is a common disorder that affects 3-9% of adult women. Treatment of     this disorder varies and includes conservative and interventional treatment.      Pelvic organs prolapse grading has an important roll in determining the appropriate     treatment. Developments in this field has led to the development of an agreed method to rate     the degree of pelvic organs prolapse (POPQ).      The roll of Urodynamic test is to assess whether there is urinary incontinence and underlying     cause.      In Richard C. et al publication, that presented the Pelvic Organ Prolapse Quantification     (POPQ) method for the first time, there was no reference to the urinary bladder state (full     or empty) during the examination, hence the investigators are asking to conduct a prospective     study in order to evaluate the degree of pelvic organs prolapse according to POPQ method     during urodynamic examination, with a full and empty urinary bladder.   "
134962|NCT01518283|"     This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel     for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with     Docetaxel.      The purpose of this study is to evaluate the activity of the weekly administration of     cabazitaxel as time to progression by PSA at week 12.   "
134963|NCT01518270|"     This study will asses epidemiologic changes in eyelash characteristics with increasing age.   "
134964|NCT01518257|"     This study will evaluate the efficacy and safety of a single intra-articular (IA) injection     of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee     pain.   "
134965|NCT01518244|"     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®     from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular     hypertension.   "
134966|NCT01518231|"     The purpose of this study is to evaluate the safety and efficacy of autologous peripheral     hematopoietic stem cell transplantation in ischemic stroke.   "
134968|NCT01518205|"     Diabetic foot (DF) is a common, severe and costly complication of diabetes. DF is underlied     by neuropathy, atherosclerosis of distal arteries and infection, which result in tissue     ulcers and necrosis. Alterations in microcirculatory function and in blood rheology may     concur in causing tissue damage.      In recent years there has been accumulating evidence that LDL apheresis (LA) does not only     reduce cholesterol but also has a series of pleiotropic effects that improve the     microcirculation, increasing peripheral tissue perfusion.      HADIF is a randomized, multicentric, prospective clinical study aimed at assessing the effect     of LDL apheresis treatment in association with traditional therapy for ulcers, in patients     with an ischemic diabetic foot ulcer (class I and II Texas Wound Classification System)and     peripheral vasculopathy not susceptible to revascularization. A total of 132 patients will be     enrolled. Participants will be centrally randomized to receive traditional therapy alone (TT)     or in association with LA. TT includes standard medication of ulcers, antiaggregant therapy     and statins. LA will be performed with HELP system, for a total of 10 sessions in 9 weeks.     The primary end-point of the study is ulcer healing; secondary endpoints include improvements     of peripheral oxygenation, resolution of pain, reduction of circulating inflammatory markers,     cardiovascular events during one year's follow-up.      This clinical Study has been approved by local EC on 25 may 2011 (Study number 1953).      TO BE NOTED: since diabetic patients in our Diabetic-Foot UNIT often presented foot ulcers     more severe than class II Texas, a formal amendment has been submitted to EC for recruiting     patients with diabetic foot ulcer of class III Texas. The amendment was already approved on 5     may 2012.   "
134969|NCT01518192|"     Background:        -  While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe          as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult          patients with erythema migrans has been assessed only in the USA where the causative          agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main          etiologic agents are B. afzelii and B. garinii.        -  Controversy exists over the significance and even the existence of post-Lyme disease          symptoms because of the high rate of similar background symptoms in the general          population.      Purpose:      The two main purposes of this European, prospective clinical trial in which doxycycline and     cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and     which included a control group to address the significance of post-Lyme disease symptoms are:        -  To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the          treatment of erythema migrans using clinical and bacteriological criteria          (noninferiority testing approach), and        -  to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM          with antibiotics and the frequency of similar symptoms in control subjects without Lyme          disease.   "
134970|NCT01518179|"     Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be     characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers),     and grip strength.      Compression gloves are used to enhance rehabilitation after various clinical conditions and     injuries. However, there are no reports on the effect of compression gloves following Distal     Radius Fracture (DRF).      This study aims to assess the incremental effect of wearing Made-to-Measure Compression     Gloves on rehabilitation following DRF.      Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up     and treatment will enhance rehabilitation, when compared with routine follow up and     treatment, in patients following Distal Radius Fracture.      ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal     Radius Fractures):      S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of     lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of     both ulna and radius: lower end (S52.6), shafts (S52.4).      S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)   "
134971|NCT01518166|"     The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug     to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®),     griseofulvin and digoxin (Lanoxin®).   "
134972|NCT01518153|"     The goal of this clinical research study is to learn what dose of a kind of immune cell     called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell     transplant has the best results. The safety of this treatment will also be studied. This will     be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma.     These results are measured as helping to control the disease without severe graft-versus-host     disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's     body.      Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants:        -  Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells,          which may cause the cancer cells to die.        -  Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die.        -  Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of          the transplant and graft-vs-host disease (GvHD).      The donor infusion of T-cells is designed to help restore the immune system after the     transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer     coming back.   "
134973|NCT01518140|"     The goal of this clinical research study is to learn if 3 breathing devices reduce feeling     short of breath in cancer patients. Researchers also want to learn if these devices can help     to control shortness of breath.   "
134974|NCT01518127|"     The purpose of this study is to evaluate the behavior of intravitreal injection of of     autologous bone marrow stem cells in patients with age related macular degeneration.   "
134975|NCT01518114|"     Exercise training (ET) is highly beneficial in heart failure patients and has been suggested     to confer significant symptomatic and functional improvements in patients with diastolic     dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a     structured ET program in symptomatic HCM patients.   "
135028|NCT01517425|"     This research is being done to understand how changes in DNA may put people at risk for     developing coronary artery disease. Stem cells will be made using cells from blood and/or     skin biopsy samples. We are trying to understand which specific changes in DNA negatively     impact a person's health.   "
135671|NCT01508949|"     This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC     90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated     with diet and/or sulphonylurea or repaglinide.   "
134976|NCT01518101|"     Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagonlike peptide-1 (GLP-1) mimetics or     analogs, which rely on the gastrointestinal hormones that are part of the incretin system for     the treatment of T2DM, provide a therapeutic alternative to common oral antihyperglycemic     agents (eg, sulfonylureas, thiazolidinediones). Although GLP-1 analogs and DPP-4 inhibitor     medications are effective, there are differences between these products, including method of     administration (injectable versus oral). Previous studies have shown that patients prefer     additional oral agents over injectable agents because of fear of injections and the desire to     avoid them. Patient preference is both clinically and financially important, as it can have     long-term implications in terms of patients' motivation and insight into their disease state     and its treatment, which might have a direct impact on the patient's compliance and treatment     adherence. The aim of the current study is to evaluate the proportion of T2DM patients     preferring oral anti-diabetic treatment with vildagliptin + metformin versus an injectable     anti-diabetic treatment with liraglutide after 4 weeks of treatment with each medication.   "
134977|NCT01518088|"     The purpose of the study is to examine how a dietary fiber affects metabolism in healthy     overweight and obese adults. The fiber will be added to foods that participants will consume     for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one     period, and 30 g per day in the other. In another three-week period, they will consume the     same foods, but with no fiber added. Major outcomes will include fermentability of the fiber,     as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The     caloric value of the fiber will be determined and metabolic measures related to blood glucose     control and inflammation will also be taken.   "
134978|NCT01518075|"     In the investigators' knowledge there are no data about the impact of non invasive mechanical     ventilation on the breathing-swallowing interaction.      Our main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive     Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute     exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)   "
134979|NCT01518062|"     This trial is conducted in Europe. The aim of this trial is to assess whether increasing     doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and     improve final height. This trial has two trial periods, a main period of 4 years and an     extension period until final height is reached.   "
134980|NCT01518049|"     The aim of this study is to develop a scale to measure the severity of depression with     psychotic symptoms (psychotic depression). Furthermore, we hope to detect potential     biomarkers (substances in the blood) which can aid in the detection of psychotic depression.      Main hypothesis: A clinically valid rating scale measuring the severity of psychotic     depression can be developed.   "
134981|NCT01518036|"     This trial is conducted in Europe. The aim of this trial is to study the dose-response     relationship and effect of somatropin (Norditropin®) on final height in girls with Turner     Syndrome.   "
134982|NCT01518023|"     There is evidence that gastrointestinal operations for non weight-losing purposes are     beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to     gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for     colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose     and hemoglobin A1c concentration.   "
134983|NCT01518010|"     This research project aims to find out if a multiplayer online video game can provide     therapeutic benefit for people who have survived a brain injury.      Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Players of     online multiplayer games behave altruistically and form friendships (Wang and Wang, 2008).     These positive emotional effects may enhance cognitive rehabilitation, because the cognitive     and emotional sides of rehabilitation are connected (Mateer, 2005).      The hypothesis is thus: that playing multiplayer online games can be a useful form of     cognitive rehabilitation for brain-injured people.      This research will identify whether or not multi-player online video games may be used as a     complementary therapeutic tool. A further aim is to develop guidelines which would help     others considering the use of video games for cognitive rehabilitation.   "
134984|NCT01517997|"     In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be     randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm     will undergo a percutaneous transluminal angioplasty (PTA) with the use of a     paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES)     study arm will undergo primary stenting using drug-eluting stent(s). The study's primary     endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will     include the immediate technical success,6-month primary patency, target lesion     revascularization and limb salvage and complication rates.   "
134985|NCT01517984|"     The study will compare how well transplanted kidneys work and the response of people's immune     systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this     research study will evaluate whether reducing immunosuppression can decrease some of these     side effects while still preventing rejection of the kidney.   "
134986|NCT01517971|"     This research trial studies biomarkers in predicting the risk of cancer returning after     surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying     samples of tumor tissue from patients with cancer in the laboratory may help doctors identify     and learn more about biomarkers related to cancer and predict how well patients will respond     to treatment.   "
134987|NCT01517958|"     The investigators hypothesize that ultrasonography of the newborn lung can be used as an     effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory     distress.   "
134988|NCT01517945|"     The purpose of this study is to customize and personalize an existing computer-based     intervention program in order to help breast cancer survivors cope with fears of cancer     recurrence.   "
134989|NCT01517932|"     Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for     short-term postoperative sedation and analgesia.It can also reduce the stress response     without respiratory depression.      In this prospective, randomized, double-blind, placebo-controlled study，we gave     dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of     dexmedetomidine on stress response and postoperative analgesia in patients undergoing     thoracotomy during anesthesia recovery period.   "
134991|NCT01517906|"     The purpose of this research study is to test a new type of counseling developed to decrease     symptoms of anorexia nervosa and bulimia nervosa and improve health and well-being in women     with these eating disorders. At this time, the most effective form of treatment for anorexia     nervosa and bulimia nervosa is cognitive behavioral therapy. However, this form of treatment     leads to a complete absence of symptoms in only about 50% of persons completing the treatment     program. In this study we will test the effectiveness of a new form of counseling that     focuses on identifying and building personal strengths and positive views of the self as the     means to decrease eating disorder symptoms and improve health. This study will involve 150     women between the ages of 18 and 35 years who currently have symptoms of anorexia nervosa or     bulimia nervosa. To participate in this study, women must also be: 1) not pregnant, 2)     without any other diagnosable mental disorder, 3) not currently taking medications for their     eating disorder or other mental disorder symptoms, 4) not ill enough to require inpatient     treatment for their eating disorder and 5) willing to refrain from seeking other treatment     for their eating disorder for the duration of this study. Each participant will participate     in a 20-week treatment program that includes nutritional counseling and medical care. Both of     these forms of treatment are considered by the American Psychiatric Association to be     essential parts of treatment for eating disorders and have been found help to reduce     symptoms. In addition, participants will receive one of two types of counseling:        1. Experimental counseling that focuses on building strengths and positive self-views        2. Standard counseling that helps the participant identify and solve problems that are          believed to contribute to their eating disorder symptoms.      The type of counseling that a participant receives will be determined randomly. To determine     whether the experimental counseling is effective, eating disorder symptoms, psychological and     functional health will be measured before the treatment begins and three times after the     treatment ends (immediately after treatment ends, 6 and 12 months later). The findings of     this research study are expected to contribute to the development of effective interventions     to decrease eating disorder symptoms, and increase health and well-being in women with     anorexia nervosa and bulimia nervosa.   "
134992|NCT01517893|"     The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical     trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new     treatment for vitiligo. The aims of this placebo-controlled study seek to determine the     safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients     with generalized vitiligo. Additionally, the investigators will collect blood to examine the     effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.   "
134993|NCT01517880|"     GNE myopathy or hereditary inclusion body myopathy (HIBM) is a severe progressive metabolic     myopathy caused by a defect in the biosynthetic pathway for sialic acid (SA).   "
134994|NCT01517867|"     The purpose of this study is to compare the effectiveness of two parenting programs in a     mental health clinic serving young children with behavior problems.   "
134995|NCT01517854|"     The investigators propose the first prospective, double blind, randomized controlled trial of     treatment for pulmonary arterial hypertension (PAH) related to underlying portal     hypertension. Specifically the investigators will evaluate the potential efficacy and safety     of sildenafil (Revatio) in a 16 week blinded, multicentre study.   "
134996|NCT01517841|"     The purpose of this study is to understand what prevents chronic kidney disease patients from     making a timely decision about dialysis modality options. This understanding will allow us to     develop and implement interventions to assist patients in this turning point so that they can     make the right decision for them in a timely enough manner so that each patient can start     dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients     (20% or less of kidney function remaining) will be asked to participate in the study with the     goal of having 150 patients participate in the study.      Hypotheses:        1. 50 % of patients will have made a modality decision when interviewed and patients in the          action stage of behavior will be more likely to make a modality selection than patients          in earlier stages of behavior change. Barriers to modality selection will act at several          levels including patient, provider and health system level and will vary by behavioral          stage of change        2. 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD,          education, and income will likely be barriers to home dialysis choice.   "
134997|NCT01517828|"     Anesthesia is rarely used to intubate newborns in delivery room because of the very     difficulty of accessing veins. The investigators hypothesized that intranasal administration     of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used     during neonates' intubation. They are also used intranasally in the absence of venous     access-In a pilot study the investigators have demonstrated that sedation with Midazolam was     effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS < 4     (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor < 0.2 spike/s.      The investigators hypothesized that intranasal ketamine would increase procedure     effectiveness from 67 to 90%.        -  Main objective: To compare newborns sedation quality as they are sedated either by          intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.        -  Secondary Objectives: To compare intubation quality, hemodynamic and respiratory          tolerance, and neurological outcomeat 2 years within the two groups.   "
134998|NCT01517815|"     Overweight patients are susceptible to develop acute complications when they are admitted in     an Intensive Care Unit (ICU). Severe infection can be associated with cardiovascular failure     ('shock) and is associated with 35-50% mortality. One of the key issue to cure infection is     to administer antibiotics. However, under dosing antibiotic is one of the main reason that     explain treatment failure. There are very few data concerning particularities of antibiotic     dosing in critically ill, overweight, patients. The aim of the present study is to describe     the pharmacokinetic of two main antibiotics (doripenem and piperacillin/Tazobactam) in both     overweight and non overweight critically ill patients presenting a septic shock. The     investigators hypothesis is that usual dose for those antibiotic may be accurate in non     overweight patients but is not in overweight patients.   "
134999|NCT01517802|"     The purpose of this study is to collect follow-up safety data from participants in completed     abiraterone acetate studies for a maximum duration of 6 years.   "
135000|NCT01517789|"     Visual morbidity (visual acuity and/or visual field deficit) must be taken into account     during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity     is due to surgical manipulation. There is no validated tool for intraoperative visual     monitoring and few publications have studied this issue.      In a preliminary work based on analysis of these publications, we defined technical,     anaesthetic and analytical parameters in order to optimise intraoperative visual evoked     potentials monitoring. These parameters are special devices used for transpalpebral     stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent     analysis criteria of visual evoked potential (VEP). We suppose that these improvements will     increase reliability of intraoperative VEP.   "
135062|NCT01516983|"     The purpose of this study is to evaluate the safety and tolerability of Icotinib at different     dose levels in combination with whole brain radiotherapy for NSCLC patients with brain     metastases and EGFR mutation.   "
135001|NCT01517776|"     The primary objective of this study is to evaluate the efficacy of a combined treatment with     cilengitide and metronomic oral temozolomide as measured by 6 months overall survival (OS)     after diagnosis of relapse or tumour progression in children and adolescents with relapsed or     refractory high-grade malignant glioma and diffuse intrinsic pontine glioma.      Secondary objectives include:        1. To evaluate the safety and toxicity of the study treatment by common toxicity criteria          (CTC; version 4.0).        2. To assess             -  the response rates at 6 months (continuous complete response = CCR, complete               response = CR, partial response = PR, stable disease = SD, progressive disease =               PD) and             -  progression-free survival (PFS) at 6 months, and             -  response rates, OS, and PFS at 12 months after relapse diagnosis or diagnosis of               tumor progression. Response will be presented including histopathological variants.        3. To assess the pharmacokinetics of cilengitide administered as part of the study          treatment.      Indication and study population for this trial:      Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas     in paediatric patients ≥ 3 years and < 18 years of age.      Patients included in the study receive        -  Cilengitide 1800 mg/m² i.v. twice weekly        -  Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory          platelet-count dependent dose adaptation rule: mandatory blood counts twice weekely:          Platelets ≥ 100 000/µl (≥ 100 Gpt/l): 75 mg/m², platelets ≥ 50 000 - < 100 000/µl (≥ 50          - <100 Gpt/l): 50 mg/m², platelets < 50 000/µl (<50 Gpt/l): stop temozolomide until          platelet recovery ≥ 100 000/µl (≥100 Gpt/l)        -  Study treatment in the individual patient is scheduled for 1 year unless tumor          progression or excessive toxicity occurs. However, study treatment may be extended          beyond 1 year upon individual decision.   "
135002|NCT01517763|"     A total of 216 patients will be randomized into a partially single blind, randomized,     parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can     improve therapy adherence when compared to standard care with a fixed pressure Continuous     Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP     device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously     diagnosed with moderate-severe obstructive sleep apnea (OSA).   "
135003|NCT01517750|"     Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper     airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the     only technological advancements shown to increase adherence is heated humidification, now     considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique     technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to     deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to     conventional humidification in reducing side effects, condensation and titrated pressure as     well as increasing total sleep time. However, improved humidity delivery has not lead to     significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.      A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a     single blind, randomized, parallel-arm trial to determine whether the the use of heated     humidification will impact therapy adherence.   "
135004|NCT01517737|"     Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with     anticipated long-term survival since the bearing surfaces wear less than the traditional     metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the     wear is a concern because of the possible toxicity to cells. In Norwich England a number of     different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had     very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom     more than 20% have now been revised. There is an ongoing MHRA program to screen for problems     using MRI scans with a technique developed in Norwich. Investigations so far show massive     corrosion in the implants with a catastrophic immune response causing death of cells. This     may include death of bone leading to fracture. In a third of patients revised there has been     pain but normal plain X-rays. In some patients without pain who have been screened there are     abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find     out why this has happened. The study will include patients coming for a new hip to act as a     comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP     THRs. We shall also investigate patients with other MoM THRs opportunistically.   "
135005|NCT01517724|"     The aim of this trial is to determine whether bortezomib improves response and delays     progression for multiple myeloma patients after high dose therapy and autologous stem cell     transplant. It will also assess the effect of bortezomib treatment on patient bone health.   "
135006|NCT01517711|"     This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for     posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related PTSD     (n = more than 20) or PTSD resulting from a civilian trauma (n = fewer than 20) will be     recruited. Blinded tramadol ER will begin with a 100 mg daily dose for the first week, with     an option to increase to 200 mg/day for the 2nd week. Dose adjustments, using a range of     100-300 mg tramadol ER per day (or 1 to 3 placebo tabs), are permitted thereafter. The     primary hypothesis is that tramadol ER 100 to 300 mg every morning for 6 weeks will reduce     the symptoms of PTSD relative to placebo. The primary outcome measures will be PTSD symptoms     as rated by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions     scale at baseline and weeks one, two, four, and six. Assignment to blinded medication arms     will be stratified to ensure equivalence of the two arms (men and women, military and     civilian trauma).   "
135007|NCT01517698|"     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will     investigate the efficacy and safety of RO4917523 in adolescent and adult patients with     fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of     RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12     weeks.   "
135008|NCT01517685|"     This research is being done to study the effect of taking flax seed oil and fish oil on blood     lipids in vegetarians following the Hallelujah Diet. Omega 3 fats are important to our health     and we want to see how effective both flax seed oil and fish oil are in raising your Omega 3     Score (higher is better). The Omega 3 Score is one of many indicators that may show your     personal risk of dying suddenly from a heart attack.   "
135009|NCT01517672|"     Identifying neural mechanisms of posttraumatic stress disorder (PTSD) treatment could help     elucidate reasons for variable treatment response and identify novel treatment targets.     Exposure-based therapies have been associated with decreased amygdala and increased cingulate     cortex response during emotional processing. The current study examined whether cognitive     therapy for PTSD in women reduces activation in insula and amygdala and enhances activation     in prefrontal regions during emotional anticipation and pre-treatment prefrontal activation     predicts treatment response.   "
135010|NCT01517659|"     Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the     ZELTIQ CoolSculpting System.   "
135011|NCT01517646|"     This study is being performed to reduce unwanted fat, in various body areas, using a new     applicator and control unit for Zeltiq.   "
135013|NCT01517620|"     This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and     safety of total glucosides paeony capsules in maintaining clinical remission in patients with     ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients     will be divided into two groups randomly, one group receive non-steroid anti-inflammatory     drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus     NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which     disease activity reaches relapse criteria. The investigator's hypothesis the proportion of     relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID     mono-therapy group.   "
135014|NCT01517607|"     This non-interventional study examines whether the patient's level of information and the     consideration of the patient's preference have a positive effect on the compliance and thus     also on the therapeutic success.   "
135015|NCT01517594|"     Confirmation of safety profile   "
135016|NCT01517581|"     White and brown adipocytes differ in their expression of hormones, cytokines, and     inflammatory factors, and they modulate different biological functions. While white adipose     tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT) instead     metabolizes fat to produce heat and regulate body temperature. BAT is likely present in all     humans, but the low prevalence of BAT depiction in adults and elderly subjects has hindered     longitudinal assessments of the relation between BAT activity and WAT. Under typical imaging     conditions, BAT is detected more frequently in children and teenagers than in adults with     malignancy. Since most children with cancer have significantly shorter treatment courses and     greater survival rates compared to adult patients, the investigators have the ability to     examine the relation of repeated measures of body composition and BAT by selecting pediatric     patients. In this study, the investigators will longitudinally examine whether BAT activity     is related to changes in weight and the amounts of SAT, VAT, and abdominal muscle in children     successfully treated for pediatric cancer.   "
135017|NCT01517568|"     This trial is conducted in Europe. The aim of this trial is characterise the metabolic     profile of liraglutide in plasma, urine, and faeces after a single injection of     [3H]-liraglutide.   "
135018|NCT01517555|"     This trial is conducted in Europe. The aim of this trial is to to investigate if there is a     drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the     effect of liraglutide on post prandial glucose.   "
135019|NCT01517542|"     Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil.     It is estimated that about 18 million people will have a stroke in 2015 and approximately one     third of these resulting in death. The factors most important modifiable risk for stroke     include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary     lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk of another     stroke. Healthy eating is among the changes in lifestyle that are recommended for prevention     and treatment of one of the main risk factors for stroke. Studies show that the adoption of     the DASH diet can significantly reduce blood pressure and the result is even more significant     in hypertensive patients, making this diet a new alternative in the prevention and treatment     of hypertension and consequently stroke. Compliance therapy is a determining factor for     success in the treatment of chronic diseases. Adherence to long-term treatment in developed     countries is around 50% and in developing countries the rates are even lower. The aim of this     study is to evaluate the effectiveness of nutritional counseling in an adapted DASH style     diet on body weight, glycemic control, blood pressure values and improved lipid profile     compared to the usual diet without nutritional counseling in patients with stroke within the     last 3 months. The hypothesis is that nutritional counseling with an adapted DASH style diet     reduces cardiovascular risk factors compared with the usual diet without nutritional     counseling in patients with stroke within 3 months. The stroke patients will be selected in     the hospitalization or in the outpatient clinic of Hospital de Clínicas de Porto Alegre in a     period up to 3 months after ischemic stroke. The patients will be randomized to one of the 2     groups. In the first visit they will be submitted to a social class and international     physical activity questionnaire and they will be submitted to a food frequency questionnaire,     measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol     and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. The main     endpoints will be the change in the body weight, blood glucose, blood pressure values and     lipid profile.   "
135020|NCT01517529|"     The major goal of this project is to identify the role of the immune responses in the     emergence of protease inhibitor mutants during therapy.   "
135021|NCT01517516|"     The structural/RSN study involves Structural and Resting State Neuroimaging. The purpose of     Structural Neuroimaging is to use MRI technology to identify cortical and white matter     morphometric differences between patients with chronic pain conditions and healthy control     subjects.      The purpose of the Resting State Neuroimaging study is to use functional MRI to identify     possible disease related differences in various resting state networks in the brain.      In addition we are looking at the effect gut microbiota on brain function in healthy and IBS     participants.      The overall goal is to identify structural and functional brain differences in persons with     chronic pain conditions such as Irritable Bowel Syndrome (IBS, Cyclical Vomiting     Syndrome(CVS) and vestibulodynia/vulvodynia. We are also looking at Inflammatory Bowel     Disease(ulcerative colitis and Crohn's disease. We will be comparing differences between     these conditions and matched healthy control subjects.   "
135022|NCT01517503|"     The study will investigate the effectiveness of Cognitive Therapy and Acceptance and     Commitment Therapy in a randomized controlled trial among patients with Major Depressive     Disorder in routine clinical practice. Furthermore, the study will investigate whether each     specific treatment approach is mediated by its proposed theoretical mechanism.   "
135023|NCT01517490|"     Retinal function is highly dependent on the glucose supply. Thus, functional adaptations     occur in response to both acute and long-term changes in glycaemia.      The purpose of this study is to examine functional and metabolic aspects of retinal     adaptation to long-lasting changes in glycaemic control in patients with diabetes. The     adaptational phenomena will be characterized by electroretinography, dark adaptation,     measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT).   "
135024|NCT01517477|"     The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure     (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on     two anti-glaucoma medications.   "
135025|NCT01517464|"     This is a Phase I study designed to evaluate the safety and maximum tolerated dose (MTD) of     SGT-94, a novel, tumor-targeted, systemic gene therapy agent for cancer. In addition, we will     look for evidence of RB94 expression within tumor tissue after systemic administration of     SGT-94.   "
135026|NCT01517451|"     A study to see how effective and tolerable radiation therapy along with androgen deprivation     therapy is in treating prostate cancer.   "
135027|NCT01517438|"     ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or     adenoidectomy in children   "
135031|NCT01517386|"     For effective anesthesia and interventional pain treatments, correct needle placement is     crucial. Currently used methods to guide needle placement and confirm the actual treatment     location before injection of the medication include: image-guidance, loss-of-resistance, and     electrical stimulation. However, accuracy of needle placement could be improved if     information would be available that would complement the current methods. We have developed     the so-called photonic needle technology based on optical spectroscopy that has the     potential to provide such complementary information.      This study is an observational study in a limited number of patients. A common     ultrasound-guided regional anesthesia procedure has been selected, during which data will be     acquired with the photonic needles at a number of points along the needle trajectory that     allow for confirmation by imaging.      Rationale for this study is to investigate the potential of the technology to discriminate     tissues that are relevant to distinguish during the procedure.   "
135032|NCT01517373|"     This is a study to understand efficacy and safety of investigational agent (PF-04937319)     compared to approved agent (glimepiride) in patients with diabetes on metformin   "
135033|NCT01517360|"     This study will evaluate whether oxytocin will facilitate the learning of social cognitive     skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training     (SCST). The primary hypothesis is that schizophrenia subjects who are treated with oxytocin     will demonstrate greater improvements in a summary measure of social cognition than subjects     treated with placebo over the course of SCST.   "
135034|NCT01517347|"     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,     option for the treatment of leukemia. However, relapse rate was still the key question to     influence the overall survival after transplantation, even in standard risk leukemia.There     were good evidences that natural killer cells and T regulatory cells, which were expanded and     stimulated by the application of IL-2, could mediate protection against GvHD while     maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in     our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a     prolonged period could be a safe and effective strategy to prevent relapse in acute     lymphoblastic malignancy patients with high risk of recurrence after unmanipulated allo-HSCT.      The study hypothesis:      Prevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation     in patients with standard risk acute leukemia can        -  reduce relapse rate        -  improve survival   "
135035|NCT01517334|"     The objective of the study is to evaluate the safety, effectiveness and anti-microbial     effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with     peri-implantitis, when used in combination with mechanical debridement.      The hypothesis of the study is that Arestin in combination with mechanical debridement is     more effective in the treatment of peri-implantitis when compared to mechanical debridement     alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as     measured at qualifying implant sites.   "
135036|NCT01517321|"     This Phase III clinical trial will examine the safety, tolerability, and efficacy of the     addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have     inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue     monotherapy.   "
135037|NCT01517308|"     Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic     hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the     efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated     whether 48 weeks of therapy may achieve better results compared to the standard duration (24     weeks).   "
135038|NCT01517295|"     Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite     hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3     months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.   "
135039|NCT01517282|"     Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous     system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an     unpredictable and variable clinical course.      Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have     been identified to contribute significantly to demyelination in both clinical MS and animal     models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates     proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic     cells and microglia with subsequent induction of proinflammatory biomolecules.      Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.   "
135040|NCT01517269|"     Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have     significantly higher diabetes knowledge (cognitive visual schemata), better technical and     problem-solving competence and confidence, and lower fear and stress/anxiety levels; and     provide better diabetes management at 14 weeks compared to those parents receiving standard     diabetes education.   "
135041|NCT01517256|"     The investigators will evaluate the effectiveness of Living Everyday Above-and-beyond Pain     (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group     therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family     Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life,     interaction with the health care system and their health care utilization. This is a pilot     study to evaluate mainly feasibility. The investigators will make use of both experimental     and qualitative methods gather evidence of the programs success, strengths and weaknesses.   "
146563|NCT01365897|"     The purpose of this study is to determine whether modafinil is effective in the improvement     of mnesic performance and executive functions of university students from high academic     performance.   "
135042|NCT01517243|"     In the past 5 years, treatment for metastatic Renal Cell Carcinoma (mRCC) has focused on     agents directed at blocking tumor and vascular growth pathways. Sunitinib blocks the vascular     endothelial growth factor receptor (VEGFr) and temsirolimus is an inhibitor of mammalian     target of rapamycin (mTOR). Both sunitinib and temsirolimus are FDA approved agents for mRCC.     When agents like these are given together, the toxicity increases but they can be given     safely, at full doses, sequentially. We hypothesize that alternating these agents will double     the progression free survival (PFS) of the agents when given sequentially.   "
135043|NCT01517230|"     A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a     comprehensive mass media campaign using local radio stations can change behaviours on a scale     large enough to result in measurable and sustainable reductions in under-five child     mortality.      It is hypothesised that as a result of the scale and multi-pronged nature of the campaign,     reductions of between 10% and 20% in child mortality will be achieved.   "
135044|NCT01517217|"     There is a considerable lack of knowledge in everyday surgical practice concerning treatment     with a corset after laparotomy, in surgery for incisional hernia or as conservative     treatment.      The aims are to elucidate effects of corset treatment on patient experience and pain,     physiology and abdominal wall strength.      Effects of corset treatment after laparotomy will be studied in a randomised trial with the     hypothesis that postoperative corset-use improves respiratory physiology and reduce pain. The     primary end-point is PeakCoughFlow change, secondary end-points are vital capacity, residual     volumes and patient perception as measured by the ventral hernia pain questionnaire (VHPQ)     developed by our group. This study is powered for 50 patients.      Conclusions from the study are of such a nature that they can be immediately transferred to     clinical practice.   "
135045|NCT01517204|"     The purpose of this study is to investigate the effects of Trachway(R) compared with direct     laryngoscope in tracheal intubation of double-lumen endobronchial tube.   "
135046|NCT01517191|"     This surveillance study will include all consenting adults hospitalized with influenza     (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to     assess vaccine effectiveness in each group. Both groups will be followed throughout their     hospitalization and for 30 days post discharge to monitor severity of illness and outcomes     following their illness.   "
135047|NCT01517178|"     The primary object of this study is to provide clinical documentation for the New base plate     significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care     base plates.      The secondary objectives are to provide clinical documentation on several performance and     safety parameters on the New base plate compared to Standard Care base plates.      The primary hypothesis is that the New base plate significantly reduces degree of leakage     under the base plate compared to Standard Care base plates.      Each test period will last for two weeks. In addition to this there will be one week run-in     period on New base plate. The data will be collected by investigator in the Case Report Form     at the inclusion visit, cross-over visit and termination visit. Data will also be collected     by the subject in a questionnaire during the two test periods.      The subjects will change their base plates on per need basis and continue with their normal     changing pattern in the entire study period.      100 subjects with ileostomy will be included in the study. The subjects will be recruited     from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.   "
135048|NCT01517165|"     Background:        -  Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and          diarrhea. Many people have these symptoms when trying to stop using opioid drugs.          Long-acting opioids like methadone and buprenorphine are used to help people stop using          other opioids, but these drugs can cause the same withdrawal symptoms. There are no          non-opioid drugs that are approved specifically to treat those symptoms.        -  Pioglitazone is a drug used to treat type 2 diabetes. In a research study, the drug          allowed heroin users to decrease their methadone dose faster without much discomfort,          and stay abstinent from heroin. Researchers want to learn more about how pioglitazone          helps treat opioid withdrawal symptoms.      Objectives:      - To test whether pioglitazone can reduce opioid withdrawal symptoms.      Eligibility:      - Individuals between 18 and 65 years of age who will be using buprenorphine to treat opioid     dependency.      Design:        -  This study will last up to 17 weeks. Participants must come to the study clinic every          day for at least 13 weeks.        -  Participants will be screened with a physical exam and medical history. They will also          answer questions about drug use habits, and provide blood and urine samples.        -  Participants will take buprenorphine daily for 7 weeks. For the first 3 weeks, the dose          will be increased to a level that should help stop the use of opioids. For the next 4          weeks, the dose will be decreased. Blood, urine, and breath samples will be collected at          different study visits. Participants will also fill out questionnaires about mood, drug          craving, and withdrawal symptoms.        -  After 1 week on buprenorphine, participants will start the study pill (pioglitazone or a          placebo) every day. They will take the study pill for 13 weeks.        -  During the treatment period, participants will have drug counseling once a week for 30          minutes.        -  Some participants have other tests as part of this study. These tests include functional          magnetic resonance imaging scans to look for changes in brain activity and giving          samples of cerebrospinal fluid to study brain chemistry.        -  Participants will have a final followup phone call 3 weeks after the last clinic visit.   "
135049|NCT01517152|"     Background:        -  The Common Terminology Criteria for Adverse Events (CTCAE) is a list of toxicities and          side effects that may occur when people are having cancer treatment. Doctors and nurses          use this list to describe the side effects patients experience from cancer treatment. We          have developed a questionnaire to ask people having cancer treatment directly about          common symptoms and side effects and to supply this information to their doctors and          nurses. This questionnaire is known as PRO-CTCAE and is completed by a patient.        -  PRO-CTCAE was originally developed in English. Researchers want to develop a Spanish          version of the patient questionnaire. To test whether the questions are well understood          and whether it is easy to complete the questionnaire, the researchers will interview          individuals whose primary language is Spanish and who are being treated for different          types of cancer.      Objectives:      - To test a Spanish version of the PRO-CTCAE questionnaire.      Eligibility:      - Latinos at least 18 years of age who are having or have recently finished cancer treatments     and whose main language is Spanish      Design:        -  Participants will complete a questionnaire in Spanish with selected questions from the          translated PRO-CTCAE. They will discuss their answers and any difficulties they might          have had in understanding or answer the questions with an interviewer, who will take          notes and record comments and suggestions.        -  Literacy is not required for this study. Participants may opt to have the questions read          aloud to them by an interviewer.   "
135063|NCT01516970|"     The primary purpose of this study is to assess the rate of early discontinuation from     randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason     other than confirmation of the negative HIV infection status of the index person in patients     receiving HIV PEP for at least 28 and a maximum of 30 days.   "
135064|NCT01516957|"     The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic     arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid     that does not have any drug in it) and neither the doctor nor the patient will know what     treatment is being given.   "
135164|NCT01515657|"     This study will determine if aspirin from PL2200, an investigational product, gets into the     blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether     PL2200 is able to prevent blood clots as effectively as these other products, when     administered to patients with diabetes.   "
135050|NCT01517139|"     Background:      - Researchers want to collect information on diet, physical activity, and sun exposure in     children and young adults. The data can provide information on the effect these factors might     have on the development of cancer and other diseases. Information collected only from adults     does not accurately measure these factors. To collect more accurate information, both mothers     and children will provide information. Study participants will be from Hebei province in     northeastern China and Jiangsu province in eastern China.      Objectives:      - To collect and study diet, activity, and sun exposure data from Chinese adolescents and     their mothers.      Eligibility:        -  Adolescents between 15 and 17 years of age from Hebei and Jiangsu provinces in China.        -  Mothers of the study adolescents.      Design:        -  Participants will answer questions about their diet, physical activity, and time in the          sun.        -  Participants will wear a pedometer to measure activity for 7 days. They will also wear a          badge to measure sun exposure for 3 days.        -  Participants will record their activities and food and drinks consumed for 3 days. Urine          samples will be collected for a full day.        -  Participants will have a grip strength test. On the last day of the study, they will          provide blood, saliva, and toenail samples.        -  A smaller separate group of adolescents will provide saliva samples only and complete a          food questionnaire.   "
135051|NCT01517126|"     Background:      - Currently, there is no standard method to study suicide risk in youth with developmental     delays or intellectual disabilities (DD/ID). Youth with DD/ID are often excluded from studies     that are used to develop these methods. As a result, most current suicide risk assessments     have not been tested for use with people with DD/ID. Researchers want to develop an effective     suicide risk screening tool for children and adolescents with DD/ID.      Objectives:      - To develop a suicide risk screening tool for young adults with DD/ID.      Eligibility:        -  Young adults between 12 and 21 years of age who have DD/ID and are in mental health          counseling.        -  Participants will be in counseling at Surrey Place Centre, a community health center in          Toronto, Canada.      Design:        -  Participants will fill out questionnaires during a 1-hour meeting with a therapist. The          questions will ask about mood and current feelings, including whether the participant          has been thinking about or planning to hurt or kill him or herself now or in the past.          Other questions will ask about participants' understanding of death in general.        -  Parents of participants may also fill out a questionnaire. It will ask about how the          participant has been feeling. It will also ask whether the parent has noticed any signs          that suggest suicidal thoughts or actions, now and in the past.        -  Treatment will not be provided as part of this protocol. However, participants can          receive counseling through the regular Surrey Place Centre services.   "
135052|NCT01517113|"     Background:      - Advancing age is associated with greater risk of heart disease. High blood pressure and     hardening of the arteries also have more complications with age. Studies suggest that     age-related inflammation may affect fatty tissue in the body. If this fat develops in the     muscles or around the heart, it may increase risks of heart disease. Researchers will study     body composition in older adults to see if age-related changes in body fat are related to     higher risks of heart disease.      Objectives:      - To study the relationship between fat deposits and aging, and greater risks of heart     disease.      Eligibility:        -  Participants in the Baltimore Longitudinal Study of Aging between 50 and 80 years of          age.        -  Individuals between 50 and 80 years of age who have been diagnosed with coronary artery          disease.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will provide blood and urine samples. They will also have their height and          weight measured. Waist circumference will also be taken.        -  Participants will have a DEXA scan to study their muscles.        -  Participants will have magnetic resonance imaging scans. These scans will study heart          function and muscle and blood vessel health.        -  Participants with coronary artery disease will have catheterization. Blood samples will          be collected during the procedure.   "
135053|NCT01517100|"     Background:      - The endocannabinoid system is involved in different body functions and processes. It helps     regulate appetite and mood, and sends signals to the nervous system. It may also be involved     in how the body produces insulin during digestion. Researchers want to test two drugs that     work on the endocannabinoid system: nabilone and CP-945,598. These drugs may be able to     affect insulin levels in the blood. This information may suggest possible new treatments for     people with diabetes.      Objectives:      - To study how the endocannabinoid system is involved in insulin production and action.      Eligibility:      - Healthy men between 21 and 55 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. They will          provide blood and urine samples. They will also have imaging studies to test their brain          responses, especially to food-related cues. Some participants will also have a study          visit to test their insulin resistance levels.        -  Participants will have four separate study visits 6 weeks apart. They will keep a food          diary before each visit. At each visit, they will have one of the following combinations          of drugs:        -  Double placebo        -  Placebo and nabilone        -  Placebo and low dose of CP-945,598        -  Placebo and high dose of CP-945,598.        -  Participants will have follow-up visits 1 week after each study visit. Blood samples          will be taken.   "
135054|NCT01517087|"     Background:      - People with motor neuron disorders have changes in the parts of the brain that control     movement. Some tests that are currently used to study these changes are magnetic resonance     imaging (MRI) and transcranial magnetic stimulation (TMS). We don t know if MRI scans and TMS     give the same results if done at different times in the same person. Researchers want to see     if these tests produce different results if given to healthy adults on two separate     occasions.      Objectives:      - To test the reliability of different tests of the brain used to study motor neuron     disorders.      Eligibility:        -  <TAB>Healthy individuals at least 35 years of age who have no history of neurological          disorders and take no medications.        -  <TAB>Pregnant women may not participate.      Design:        -  Participants will be screened with a medical history and physical exam.        -  Participants will have two testing visits 1 to 6 months apart.        -  The first visit will have three parts. The first part is a neurological exam to test          strength, sensation, reflexes, and coordination of movement. The second part will be TMS          tests. The third part will involve an MRI scan to study the parts of the brain that          control movement.        -  At the second visit, participants will have MRI scanning only.   "
135055|NCT01517074|"     Background:      Autoimmune scleritis is an inflammatory disease that affects the white outer part of the eye.     It is associated with immune system disorders like rheumatoid arthritis. It can cause     blindness in severe cases. Most treatments for scleritis involve steroid or     immune-suppressing drugs, but these can cause side effects in the whole body.      Sirolimus is a drug used to help prevent transplant rejection. It helps prevent the immune     system from attacking the body. Researchers want to try giving sirolimus injections into the     eye to treat severe scleritis.      Objectives:      To see if sirolimus is a safe and effective treatment for autoimmune scleritis.      Eligibility:      Individuals at least 18 years of age with autoimmune scleritis in at least one eye that has     not responded to standard treatments.      Design:        -  Participants will be screened with a medical history, physical exam, and eye exam. Blood          and urine samples will also be collected.        -  One eye will be selected as the study eye to receive injections.        -  Participants will have six study visits over 4 months (initial visit and weeks 2, 4, 8,          12, and 16). The injection will be given at the first visit. If the study eye responds          to the treatment, participants may have injections in the other eye at the second visit.        -  If there is still inflammation after the first injection, or if the scleritis improves          but then returns, participants may have a second injection at Week 4.        -  Injections will be monitored with blood tests and eye exams.        -  Participants may have study visits and injections for up to 1 year if the injections          seem to be working.   "
135056|NCT01517061|"     Background:      - Many people who lose a limb feel pain in the missing limb. This feeling is called phantom     limb pain. Researchers do not fully understand what causes this pain. Differences in people's     genes may play a role. Comparing the genes of people with and without phantom limb pain may     help researchers better understand this feeling, who is likely to develop it, and how to     treat it.      Objectives:      - To study whether genetic differences affect phantom limb pain.      Eligibility:      - Individuals at least 18 years of age who have lost an arm or leg at least 3 months ago.      Design:        -  Participants will be screened with a medical history and physical exam.        -  Participants will answer questions about how they lost the limb, and whether they feel          phantom limb pain. They will also have a test to measure their sensitivity to heat and          cold.        -  Participants will provide a blood sample for genetic testing.   "
135057|NCT01517048|"     Background:      - Prader-Willi syndrome (PWS) and MC4R genetic mutations are two conditions that can cause     problems with appetite regulation. People with PWS often have behavior and thinking problems.     People with MC4R mutations may have problems with attention. These problems may be related to     Brain-Derived Neurotrophic Factor (BDNF), a protein that is important for brain development.     Researchers want to study people with PWS and MC4R mutations to see how BDNF is involved in     these conditions. Specifically, body weight and brain function will be studied, and compared     with healthy volunteers.      Objectives:      - To study how BDNF affects body weight and brain function in people with PWS and MC4R     mutations.      Eligibility:        -  Individuals of any age who have Prader-Willi syndrome or MC4R genetic mutations.        -  Healthy volunteers of any age to act as control participants.      Design:        -  Participants will be screened with a medical history and physical exam. Height, weight,          and waist/hip circumferences will be measured. Blood samples will be taken for genetic          and other tests.        -  Participants will fill out questionnaires about eating habits, pain perception, and          sleep behavior.        -  Participants will keep a 3-day food diary to record all food and drinks eaten.        -  Tests and questionnaires will be given to study thinking, speech, movement, behavior,          and mood. Some tests will be done on a computer; other tests will be on paper. Tests may          also involve performing tasks with blocks and other objects.        -  Participants may have other tests as directed. These will include hot and cold          sensitivity tests, imaging studies like x-rays, and measurements of body fat and water          content.        -  Treatment will not be provided as part of this study.   "
135058|NCT01517035|"     Background:      - People who have some kinds of cancer can benefit from donated bone marrow stem cells. These     stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells.     However, stem cells transplants do not always work. Also, they may have serious side effects     that can cause illness or death. The Bone Marrow Stem Cell Transplant Program is studying     methods to make stem cell transplant procedures safer and more effective.      Objectives:      - To test a new procedure that may improve the success and decrease the side effects of stem     cell transplants.      Eligibility:        -  Individuals 10 to 75 years of age who have a life-threatening illness that may require a          stem cell transplant.        -  Healthy siblings who are able to provide stem cells for transplant.      Design:        -  Participants will be screened with a medical history, physical exam, and blood and urine          tests.        -  Donor procedures:        -  Stem cell donors will start by having apheresis to donate white blood cells.        -  Donors will receive filgrastim shots for 5 days to help move stem cells into the blood          for collection.        -  Donors will have another round of apheresis to donate the stem cells for transplant.        -  Recipient procedures:        -  Before the transplant, recipients will have radiation twice a day for 3 days and          chemotherapy for 7 days.        -  After the radiation and chemotherapy, recipients will receive the stem cells provided by          the donor.        -  After the transplant, recipients will receive the white blood cells provided by the          donor.        -  Recipients will be monitored closely for 4 months to study the success of the          transplant. They will have more followup visits at least yearly thereafter.        -  Recipients will have a research apheresis prior to transplant and at 3 months.   "
135059|NCT01517022|"     The aim of the study is to determine the impact of a package of smoking-cessation     interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.      Given the lack of objective clinical data/evidence about the impact of smoking-cessation on     TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to     be beneficial particularly in patients with TB, this study proposes to determine the impact     of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation     (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis     therapy. This is to be compared with the structured counselling for smoking-cessation that is     recommended to be routinely provided by health care workers to all patients who are smokers.     If the results prove that such a smoking-cessation PI indeed improves outcomes in TB     patients, such information would strongly motivate for the institution of more intensive     smoking-cessation interventions in TB clinics than is currently being employed for TB     patients   "
135060|NCT01517009|"     The purpose of this study is to determine the feasibility of chemotherapy, consisting of     docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore,     an extended type of removal of lymph nodes will be implemented.   "
135061|NCT01516996|"     The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to     neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally     advanced squamous cell carcinoma of the oropharynx and hypopharynx.   "
135065|NCT01516944|"     Stage I：Neoadjuvant therapy        -  Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to          surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and          Oteracil Potassium Capsules plus oxaliplatin      Stage II: Perioperative therapy        -  Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is          superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin          alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and          Oteracil Potassium Capsules plus oxaliplatin        -  A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and          Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable          locally advanced or metastatic gastric cancer. The investigators assessed whether the          addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves          R0 resection rate and survival among patients with curable locally advanced gastric          cancer.   "
135066|NCT01516931|"     The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic     stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome     Measures:Time between subject randomization to treatment and the first occurrence of a     relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as     measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by     Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject     functioning using the Personal and Social Performance Scale.   "
135067|NCT01516918|"     The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen     (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with     cirrhosis.   "
135068|NCT01516905|"     The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404     PET/CT in humans with brain metastases and GBMs. This goal will be accomplished by     determining the optimal PET/CT protocol and comparing PET tumor uptake to MRI and calculating     tumor dosimetry. A future aim of this study will be to compare non-invasive PET/CT and MRI     findings with pathological specimens, which is the gold standard but is invasive and     impractical in many cases, to determine the sensitivity and specificity of both techniques     for accurately detecting tumor infiltration. The data obtained from this study will be used     to develop larger diagnostic and therapeutic trials in brain tumors. The long-term goals of     this research are to improve the diagnosis and treatment of malignant brain tumors by using     radioiodinated NM404.   "
135069|NCT01516892|"     This open-label study will assess the long-term efficacy, safety, and tolerability of     onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic     migraine.   "
135070|NCT01516879|"     To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC)     evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering     therapy.   "
135071|NCT01516866|"     The purpose of this research study is to evaluate a newer imaging technique, called     18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is     very sensitive for changes in bone. By using this tracer with positron emission     tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes     in bone lesions could be greatly improved.   "
135072|NCT01516853|"     The purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic     iron concentration (HIC). Excessive accumulation of iron in the body is highly toxic,     specifically in the liver. Accurate, non-invasive assessment of HIC is needed for diagnosis,     quantitative staging and treatment monitoring or hepatic iron overload.   "
135073|NCT01516840|"     The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and     pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein     thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary     embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.   "
135074|NCT01516827|"     This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused     Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino & Deblinger (2006)     with a wait-list condition in a population of children aged 7-16 years who were exposed to     traumatic events beyond the age of three years, at least three months ago, and developed     Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT     exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of     treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the     effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of     patients and caregivers and to explore moderators and mediators of treatment response. The     trial will contribute to implement an evidence-based treatment for traumatized children     across a variety of healthcare settings in Germany. The novel aspect is to evaluate the     effectiveness of TF-CBT with a broad range of traumatized real-world patients in the     context of the German mental healthcare system.   "
135075|NCT01516814|"     The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and     pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the     prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in     Japanese patients with acute symptomatic PE with or without symptomatic DVT.   "
135088|NCT01516645|"     This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as     monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy     or for whom no standard therapy is available.   "
135089|NCT01516632|"     The investigators developed a text messaging-based smoking cessation program called SMS (Stop     My Smoking) USA. It was tailored for the unique needs and smoking habits of young adults. The     investigators hypothesized that those in the SMS USA intervention would be significantly more     likely to be quit at 6-months compared to the attention-matched control group.   "
135090|NCT01516619|"     This is a monocentric, prospective phase II trial addressing safety and capability to prevent     grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with NHL.   "
135137|NCT01516008|"     The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR     50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours     (SPID48) to measure analgesic effect in Korean patients with acute pain following     bunionectomy.   "
135076|NCT01516801|"     1. Does a one-page American College of Physicians educational flyer about the pros and cons          of prostate cancer screening sent to men within two weeks of their scheduled annual          health examinations in a general medicine clinic result in a different rate of prostate          cancer screening than among men who were not sent the flyer?        2. Do patients find the flyer useful and understandable?      Context: The use of prostate specific antigen (PSA) screening for prostate cancer is     controversial because of a lack of evidence that such screening saves lives when applied     within a population and because such testing can lead to invasive downstream biopsies and     aggressive treatment that is associated with a high risk of permanent side effects (e.g.     impotence, incontinence). Almost all professional societies (American Cancer Society,     American Urologic Association, American College of Physicians, United States Preventive     Services Task Force) advocate that patients receive education and complete an informed     decision-making discussion with their medical providers about the pros and cons of the PSA     test, as well as their personal preferences, before proceeding with this test. Unfortunately,     despite these recommendations, there is seldom sufficient time during clinic visits to     achieve this goal.   "
135077|NCT01516788|"     Photosensitivity is well documented among lupus patients and is one of the diagnostic     criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in     lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly     defined in lupus and its pathogenesis is not well understood. The purpose of this study is to     characterize the early clinical and histopathological changes in lupus skin that occur as a     response to ultraviolet light.   "
135078|NCT01516775|"     Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to     minimize the risk of regurgitation, vomiting and pulmonary aspiration during general     anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of     this study and can be investigated in children undergoing elective procedures in intubation     anaesthesia without inconvenience or additional invasive procedure and hence without     additional risk      Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia     induction than in those that drink until 2 hours before anaesthesia induction   "
135079|NCT01516762|"     This study is a prospective, interventional, open-label, multi-center early access program     for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis     and to collect additional short and long term safety data on the product.   "
135080|NCT01516749|"     This is an open-label, proof-of-concept research study to assess the effectiveness of     anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned     intervention is to provide about 6 HS patients with anakinra 100mg daily injections to     administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a     further 8 weeks to monitor for relapse of HS.   "
135081|NCT01516736|"     The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the     mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in     breast cancer patients.   "
135082|NCT01516723|"     Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by     high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark     reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared     to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar     favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic     Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also     demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with     bioresorbable polymer coatings were developed, to address safety concerns regarding the     observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic     inflammation, on the durable polymer coating of DES. However, none of these DES with     bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a     prospective, randomized, single-blinded, multi-center trial, designed to evaluate the safety,     efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable     polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with durable polymers     (Xience Prime, Abbott) in patients with successfully recanalized TCOs.   "
135083|NCT01516710|"     The purpose of the study is to compare outcomes of laparoscopic versus open liver resection     for colorectal metastases in a prospective and randomized study. The study will include all     non-anatomic liver resections in our institution.      The primary end point is that the use of laparoscopic technique significantly can reduce the     frequency of complications to liver resection. Secondary end points are 5-year survival,     immediate surgical outcomes, quality of life and degree of impairment of the immune system.   "
135084|NCT01516697|"     The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac     output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician     promptly, 2) provide information for the physician to make the differential diagnosis as to     whether the hemodynamic instability was due to vasodilatation or reduction of venous blood     return, and 3) lead to appropriate and prompt treatment to improve patient outcome.      -determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic     profile of the patient under spinal anesthesia for cesarean section. To determine if using     instantaneous measurements of SV and CO to guide patient management improves hemodynamic     stability.   "
135085|NCT01516684|"     This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients     undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the     skin and reducing movement when applied prior to lumbar punctures and may reduce the amount     of sedation necessary   "
135086|NCT01516671|"     Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to     severe disability in survivors caused by cerebral vasospasm and infarction.      This study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol     levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of     the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.   "
135087|NCT01516658|"     HYBRID study is prospective randomized open label controlled multi center trial, to compare     Hydrocoil and bare platinum coil for recanalization after endovascular treatment of     intracranial aneurysms.   "
135092|NCT01516593|"     This is a multicenter,open-label trial to evaluate activity and safety of the investigational     intensive in HIV+ patients with Burkitt's lymphoma.      Experimental treatment consists of an induction phase followed by a consolidation or     intensified phase according to tumor response.      Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was     thought to limit the ability to administer intensive chemotherapeutic regimens due to     infection rate. However, the advent of highly active antiretroviral therapy (HAART) and     evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard     chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive     patients with the same intensive chemotherapy regimens used to treat immuno-competent     patients. Data suggest that these current approaches, along with supportive care, may result     in improved patient outcomes, similar to those in the immuno-competent patient population.   "
135093|NCT01516580|"     The aim of the trial is to test whether adding 6 injections of rituximab to standard     Lymphome malin B LMB chemotherapy regimen improves the Event Free Survival (EFS) compared     with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin     Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL).   "
135094|NCT01516567|"     Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children     and adolescent with primary mediastinal large B cell lymphoma in terms of event free     survival.   "
135095|NCT01516554|"     Fatigue is one of the most frequent symptoms reported by multiple sclerosis (MS) patients and     is often a significant source of disability. Unlike normal fatigue, multiple sclerosis     related fatigue (MSRF) occurs independently of activity level, suggesting that it is due to     dysfunction in the neural pathways that regulate the perception of energy although the     precise cause is still not understood. While MSRF can be managed through lifestyle     modifications and with drug treatment, these measures are commonly either ineffective or only     partially effective.      Administration of the male sex hormone testosterone has been shown to improve energy levels     in males with testosterone-deficiency states. Testosterone also reduces fatigue in patients     with other medical conditions not associated with low testosterone levels, suggesting that     this treatment may also be useful in symptomatic control of MSRF.      This proposed seven-month long clinical trial is designed to test the hypothesis that     administration of oral testosterone tablets to male MS patients will result in an improvement     of fatigue relative to the administration of placebo tablets. As fatigue is frequently     reported by MS patients to be one of their most frustrating and disabling symptoms, any     proven additional treatment option for MSRF would be beneficial in improving quality of life.   "
135096|NCT01516541|"     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will     evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in     patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated     risk for cardiovascular disease. Eligible patients will be randomized to receive either     dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary,     guidelines-based medical care. Anticipated time on study treatment is 4 years.   "
135097|NCT01516528|"     This is a prospective, observational, non-drug interventional, non-randomized study to     compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive     Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study     population of 3330 subjects will be recruited by general practitioners (GPs) and assessed     over a 27 month time frame.   "
135098|NCT01516515|"     This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum     undatum plant extract in patient with Actinic Keratosis (AK).   "
135099|NCT01516502|"     Objective: To compare the effectiveness of application of low-level laser therapy (LLLT) to     trigger points and traditional acupoints for patients with cervical myofascial pain syndrome     (MPS).      Design: A single-blinded, randomized, placebo-controlled trial Setting: University     rehabilitation hospital Participants: One hundred and twenty one patients with cervical MPS     Intervention: The investigators performed this experiment using low level 810-nm gallium     aluminum arsenide (Ga-Al-As) laser. One hundred participants were randomly assigned to four     treatment groups, including (1) acupoint therapy (2) acupoint control (3) trigger point     therapy and (4) trigger point control groups.      Main Outcome measures: The investigators evaluated the patient's visual analogue scale (VAS)     pain scores, pressure pain threshold and cervical range of motion (ROM) before and after the     therapy.   "
135100|NCT01516489|"     This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial     incentives directly integrated into primary care can improve fecal occult blood test (FOBT)     completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs     Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care,     $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of     FOBT completion. We also hypothesize that there will be a direct dose-response relationship     between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a     lottery-based incentive and a raffle-based incentive will both lead to a statistically     significant increase in the rate of FOBT completion compared to a fixed payment incentive     with an equivalent dollar per patient value.   "
135101|NCT01516476|"     This randomized, double-blind, placebo-controlled, multi-center study will evaluate the     efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately     controlled with metformin alone. Patients will be randomized to receive doses of RO6807952,     placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.   "
135102|NCT01516463|"     Subjects who have minor, second degree burns may be enrolled in this study. Subjects will     receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals.     Bandages will be used to keep the burn covered while it heals. Second degree burns generally     leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to     minimize the appearance of a scar.      The study hypothesis is that burns treated with Santyl will have a better scar appearance     than burns treated with bacitracin.      Subjects enrolled in this study will make once a week visits to the University of Kansas     Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for     healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up to     1 year. At these visits, the appearance of the scar will be evaluated   "
135103|NCT01516450|"     This study is an open-label, randomized, 2 parallel group, single dose study in healthy     Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous     administration and single subcutaneous administration of GSK1550188. Serial blood samples for     the determination of GSK1550188 concentration will be collected and safety assessments will     be performed for each treatment group   "
135104|NCT01516437|"     The present study aims to assess the natural immunity to specific microbial antigens in     healthy subjects and in subjects with stable COPD aged between 45-75 years.   "
135105|NCT01516424|"     A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical     trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone   "
135106|NCT01516411|"     The purpose of this research is to test programs to increase physical activity and reduce     sedentary behavior using motivational messages over a cell phone.   "
135107|NCT01516398|"     A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes     and death for premature infants. Infants with BPD are also at high risk for pulmonary     hypertension (PH)—an important contributor to their condition. Previous research has     suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary     disease.      This study aims to investigate the incidence of PH and levels of ET-1 among premature babies     with BPD. It will also potentially allow us to focus further research efforts and treatment     towards these infants, some of our sickest patients at LPCH.   "
135108|NCT01516385|"     This research looks for markers in the blood of people with spinal cord injury that may be a     sign of injury severity, or serve as a clue to the degree of recovery. Investigators would     also like to compare the marker profile of these patient with that of other neurological     conditions such as stroke and Guillain-Barre syndrome.      Patients participating in this trial will be those accepted to neuro-rehabilitation in Sheba     medical center, Israel. They will join the trial at their arrival to the ward, no less than 2     week after the beginning of their condition, but no later than 3 months.      Patients will be examined by the research staff three times:        1. At arrival, the patients will be neurologically examined and their functional abilities          will be assessed. Blood will be drawn and sent to the lab.        2. At 6 months after the beginning of the neurological condition the same will be repeated:          the patients will be neurologically examined and their functional abilities will be          assessed, and blood will be drawn and sent to the lab.        3. The final examination will take place 1 year after the beginning of the neurological          condition. This time only the neurological and functional abilities will be assessed          without blood tests.      The blood samples will be tested in the research lab. Then investigators shall compare the     clinical findings with the laboratory findings, and see if any of the markers found reflect     the injury severity or predict the recovery.   "
135109|NCT01516372|"     This will be a randomized, double-blind, placebo- controlled cross-over study to investigate     the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive     control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take     part in four dosing sessions. Subjects will receive, in a randomized order, a single dose of     1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive control) and     placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose to     approximately 24 hours after dosing on Day 1 of each study session. The primary comparison of     interest will be the mean change from baseline in the time-matched differences in QTcF     between each GEn treatment and placebo.   "
135110|NCT01516359|"     The purpose of this study is to investigate the incidence and predictive factors related to     intestinal injury in patients undergoing heart valve replacement through a multicenter study     in China.   "
135111|NCT01516346|"     The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide     dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints     include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity     (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection     Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave     reflections induced by vasoactive therapy will correlate with the improvement in exercise     capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the     hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the     sustained changes in the reflected wave and other hemodynamic parameters in response to     chronic vasodilator therapy.   "
135112|NCT01516333|"     The study is to examine the effect of four diets differing in glycemic index and amount of     carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.   "
135113|NCT01516320|"     The objective of this study is to investigate the different mechanisms by which Gastric     Bypass (GBP), laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy     (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in     gut peptides in the short and long term in morbidly obese patients with Type 2 Diabetes     Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent     weight loss and at after surgery in terms of gut hormones levels, insulin secretion and     glucose control.   "
135114|NCT01516307|"     The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in     combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects     with stable disease or response to treatment.   "
135115|NCT01516294|"     This study will evaluate the efficacy of IRay treatment in patients with Polypoidal Choroidal     Vasculopathy (PCV)secondary to AMD as determined by the change in the proportion of lesion     activity and lesion size at 12 months.   "
135133|NCT01516060|"     The purpose is to investigate whether HIV and HIV medication can affect certain areas of     brain function. This study will look at possible changes in brain function including memory,     concentration and thought processes to see if there are any differences between the two doses     of efavirenz used in the Encore1 study and also the level of efavirenz in the blood   "
135134|NCT01516047|"     The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult     male patients with severe hepatic impairment and is being conducted to collect information     that will support clinical dosing recommendations for this subpopulation.   "
135135|NCT01516034|"     The study is designed to determine the efficacy of the Cupola tattoo removal device for     tattoo removal.   "
135116|NCT01516281|"     The purpose of this study is to learn if a new brain imaging technology called DaTscan can     detect subtle changes in the brain that are similar to those seen in early Parkinson's     disease (PD). The results of this study may provide more information about a possible     association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of     this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122     subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University     HealthSystem during the years 2006-2011, and to select from willing eligible subjects a     random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to     undergo written informed consent, neurological examinations, blood drawing for DNA extraction     and storage, and DaTscan brain imaging. The investigators will compare the findings from     persons who experienced mTBI (cases) to persons without a history of brain injury (mTBI- or     controls).   "
135117|NCT01516268|"     Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound     guide can reduce narcotic dosage, side effects and pain after cesarean delivery.   "
135118|NCT01516255|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered     as positive control.   "
135119|NCT01516242|"     This study is conducted in Europe. The aim of the study is to monitor patients changing     therapy from syringe to insulin delivery system as prescribed by the treating physician in     Slovakia.   "
135120|NCT01516229|"     This study is conducted in Japan. The aim of this study is to assess the incidence rate of     adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for     achondroplasia without epiphyseal line closure under normal clinical practice conditions.   "
135121|NCT01516216|"     The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor     in the cancer cells, it may stop cancer cells from growing abnormally and may cause cell     death. Vitamin D has been used in other research studies and information from those other     research studies suggests that Vitamin D may help in the treatment of colorectal cancer.      In this research study, the investigators are comparing standard and higher dose Vitamin D     treatment when given in combination with standard treatment for metastatic colorectal cancer.     Standard treatment includes the chemotherapy combination of 5-FU, Leucovorin and Oxaliplatin     (FOLFOX) with bevacizumab.   "
135122|NCT01516203|"     The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day     14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily,     500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with     newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled,     with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration of     drug treatment is 14 days.   "
135123|NCT01516190|"     This study is designed to look at the changes that occur in women who take part in exercise     and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators     will look at changes in stress, anxiety, mood and quality of life, to see if these types of     short programs can make women feel better during this time. The investigators are also     interested in looking at whether a short exercise or Mind-Body program leads to any changes     in markers in breast cancer cells, such as their growth and death rates, or in blood hormones     such as insulin, which have been linked to breast cancer development.      Since the investigators do not know if these blood or tumor tests have any relationship to     cancer recurrence, the investigators do not plan to share the results of these tests with you     or your physician.   "
135124|NCT01516177|"     This is an observational study for people who have received a kidney transplant within the     past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and     cells in the blood that has been found in a group of rare transplant patients who do not need     immunosuppression. The study goal is to find out how common this pattern is in transplant     patients, as a first step in determining if it can be used to personalize anti-rejection drug     regimens better.   "
135125|NCT01516164|"     Videolaryngoscopes offer the potential to make tracheal intubation easier for the     anaesthetist and less traumatic for the patient. This study aims to compare the intubation     difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC     as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen)     and the MacIntosh laryngoscopes.   "
135126|NCT01516151|"     To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma     serum triglycerides over a four week period in patients with mild-to-high     hypertriglyceridemia as compared to the standard of care alone.   "
135127|NCT01516138|"     The purpose of this study is to evaluate the effects of modified glucose - insulin -     potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).   "
135128|NCT01516125|"     The purpose of this research study is to screen healthy African American and Caucasian     persons for specific differences in genes that control how fats are processed in the body.   "
135129|NCT01516112|"     The purpose of the registry is to assess workload of a Home Monitoring based follow up for     Biotronik ICD and CRTD patients.   "
135130|NCT01516099|"     The primary aim of this study is to investigate how a physical activity counselor can offer     an added value in the sports and exercise promotion in Flanders. The investigators will     explore if the physical activity counselor, in collaboration with the setting of general     practitioners and social-cultural associations, can refer sedentary people and persons who     are active in a non-organized context, into systematic participation in sports and/or     exercise. Additionally, the investigators want to determine if the physical activity     counselor will succeed in referring the target population to the local supervised and     structured sports and exercise activities.   "
135131|NCT01516086|"     This will be a multi-center, randomized, placebo controlled parallel-group study to Replicate     Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled     and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including     12 weeks of double-blind treatment.   "
135132|NCT01516073|"     This will be a multi-center, randomized, placebo-controlled parallel-group study to evaluate     nebulized fluticasone propionate (FP) dose response in adult subjects with partly controlled     and uncontrolled asthma. Individual participation will be approximately 16 weeks, including     12 weeks of double-blind treatment.   "
135139|NCT01515982|"     The state of the art with regard to the neurodegenerative dementias, especially for     Alzheimer´s disease (AD), is that their progression is still irreversible causing cognitive,     motor, and behavioral impairment. Although the current pharmacological treatments attenuate     cognitive decline in some cases, the majority of treatments does not avoid the motor and     functional changes caused by the progress of the disease. Although several studies show that     exercise has a positive effect when it comes to the treatment of the disease, some     methodological questions affect the application of the training protocols. The use of     recognized intensity patterns like maximum oxygen uptake (VO2max) and maximum heart rate     (HRmax) percentage to control the training of patients with dementia is still rare in the     literature. Therefore, this seems to interfere on the definition of an ideal prescription.     Following this line of reasoning, the purpose of the present study is to assess the effect of     moderate aerobic exercise on cognition and functional abilities in AD patients. Design:     Randomized controlled trial, double-blinded, with 16-week follow-up. Setting: Center for     Alzheimer's disease in the Institute of Psychiatry of the Federal University of Rio de     Janeiro. Participants: Elderly with Alzheimer disease. Interventions: The patients will be     randomly assigned to an exercise group (EG) on a treadmill (30 minutes, twice a week and     moderate intensity of 60% VO2max) and a control group (CG). Main outcome measures: Cognitive     function will be assessed using CAMCOG, Trail Making Test A, Digit Span, Stroop Test, Rey     auditory-verbal learning test and Clock Test, and functional capacity will be evaluated using     Berg Balance Scale (BERG), Sit-to-Stand test (STS), functional reach test (FR), and the time     to up and go test (TUGT).   "
135140|NCT01515969|"     This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib     together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the     epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer     and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which may     be important to treat lung cancer. The combination of both drugs may work better than either     drug alone, but may also have increased side effects. This trial will look at the side     effects of combining the drugs and look for how effective the combination may be.   "
135141|NCT01515956|"     This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk     infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of     administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome)     for up to 208 weeks.   "
135142|NCT01515943|"     The purpose of this study is to determine the effectiveness of home-based computer therapy     for symptomatic convergence insufficiency (CI) compared to traditional home-based near target     push-ups and placebo treatment.   "
135143|NCT01515930|"     The purpose of this study is to develop an intervention to increase parental motivation for     supervision and monitoring youth diabetes care behavior. The intervention will be tested in     three brief session in conjunction with regularly scheduled diabetes clinic visits and     delivered through a computer program based in the principles of Motivational Interviewing.   "
135144|NCT01515917|"     This is a placebo-controlled study intended to examine the effects of the neutraceutical     citicholine, together with omega-3 fatty acids, on a range of measures in individuals with     concussive head injury, often referred to as traumatic brain injury, or TBI. The study will     consist of three visits, during which participants will complete brain scans, a thorough     testing battery and a clinical interview to assess mood and other diagnostic information     relevant to the study.   "
135145|NCT01515904|"     In January 2010 a new interdisciplinary clinic (STOMP) was created to provide care for     children and adolescents with severe 'complex' obesity. As part of the program, a subset of     adolescents undergo bariatric surgery. There is a paucity of literature evaluating outcomes     of children and adolescents participating in a 'clinical' setting and even fewer reports of     outcomes of severely obese pediatric patients. Previously, the investigators evaluated     clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an     outpatient interdisciplinary program at SickKids (The Comprehensive Care Clinic for Children     with Central Tumours) and found significant benefit to those attending, including reduction     of weight gain (or weight loss), improved psychosocial functioning, and increased care     satisfaction. STOMP is a natural extension of this program, incorporating some core elements     (e.g., interdisciplinary team, frequent visits, individualized care plans for     medically-complex adolescents) and building on other aspects, such as increased psychosocial     intervention; involvement of a key worker (nurse practitioner) to support families;     provision of continuity of care with other health providers in all settings, community     services and schools; a more diverse patient population; and group support sessions.     Evaluation of the outcomes of this clinic is needed to inform best practice for children and     adolescents with severe complex obesity   "
135146|NCT01515891|"     To determine the absorption, metabolism and excretion of BIA 9-1067.   "
135147|NCT01515878|"     It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves     long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and     by reduced incidence of intradialytic hypotensive episodes   "
135148|NCT01515865|"     To study the effect of midodrine against the symptoms of orthostatic hypotension   "
135149|NCT01515852|"     Examination of stress level in general anesthesia in comparison to local anesthesia in     stereotactic biopsy   "
135162|NCT01515683|"     Studies shows that reduced nervousness before anaesthesia may improve a course past     anaesthesia. Therefore it is interesting to investigate how we can best help patients shortly     before anaesthesia. A RCT with three intervention arms (with different personal support) and     a control arm (with usual personal support) is therefore performed.      Hypothesis: Nervousness is reduced by the new interventions compared to the usual help     provided.   "
146564|NCT01365884|"     Proof of concept study to compare the best corrected visual acuity obtained via First-Sight     lenses with the autorefraction in children.   "
135165|NCT01515644|"     In this study the effect of Infant formula with added Inulin will be compared with the effect     of Infant formula without Inulin on the Bifidobacterium level in stool.      It is expected that drinking Infant formula with added Inulin will result in higher     beneficial bacteria level in stool compared to an Infant formula without Inulin.   "
135150|NCT01515839|"     The investigators primary objective is to acquire preliminary data on one-hundred former NFL     veterans with at least one full year of professional service using brain SPECT imaging in     order to assess the degree to which NFL football puts players at risk for traumatic brain     injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in     neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house     proprietary database comprised of the brains of healthy subjects.      The investigators secondary objective is to acquire additional data on these players such     that investigators may establish causative factors and risks associated with said TBI.      The investigators tertiary objective is to acquire data on subjects using various mental     health metrics in order to determine the effects of TBI.   "
135151|NCT01515826|"     The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate     0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%)     ophthalmic solution in the prevention of postoperative inflammation and infection.   "
135152|NCT01515813|"     Since people started taking HIV medications, illnesses related to AIDS have decreased, but     other serious illnesses like heart disease (heart attacks) and certain kinds of cancer have     increased. Studies show that HIV causes changes in the lining of the arteries and also causes     inflammation (irritation) inside the body that may play a role in diseases like heart attacks     and strokes. The levels of inflammation and artery lining health can also affect how well     your brain works. These changes cannot be felt, but can be measured. Artery lining health can     be looked at with a test that uses a blood pressure cuff on your arm to see how the artery     responds when air is let in and out of the cuff. An ultrasound (machine that uses sound     waves) is used to look at the artery during the test. This test is called Flow Mediated     Dilation or FMD for short. Inflammation can be checked with blood tests (blood tests that     measure this irritation inside the body that you cannot feel). HIV medications can improve     the artery lining health and can partially lower levels of inflammation in the blood;     however, these levels of inflammation may not be able to return back to normal.      Pravastatin sodium is a medication that is approved by the Food and Drug Administration (FDA)     for treating high cholesterol. Pravastatin sodium has also been able to improve the health of     the lining of the arteries and lower the level of inflammation in people with other diseases,     but has not been studied or approved for this purpose in people who have HIV. This research     study will look at the effects of two types of medications used separately or together on the     health of the lining of arteries and levels of inflammation in the blood: Atripla (a HIV     medication) and pravastatin sodium. This study will also look at the effects of Atripla and     pravastatin sodium on cholesterol levels, tests that measure how well you can think and     calculate (tests of neurocognitive function), and at the effects of Atripla on the levels of     pravastatin sodium in the blood.   "
135153|NCT01515800|"     RATIONALE: Measuring how text-message affects treatment compliance in women with breast     cancer may help doctors plan the best treatment.      PURPOSE: This randomized trial studies how well text-message works in reducing early     discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who     underwent breast surgery.   "
135154|NCT01515787|"     The standard treatment for locally advanced rectal cancer involves chemotherapy and     radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation     therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and     important part of treatment for rectal cancer and has been shown to decrease the risk of the     cancer coming back in the same area in the pelvis, some patients experience undesirable side     effects from the radiation and there have been important advances in chemotherapy, surgery,     and radiation which may be of benefit. The purpose of this study is to compare the effects,     both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy     using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin     and leucovorin) and selective use of the standard treatment, depending on response to the     FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved     and have been used routinely to treat patients with advanced colorectal cancer.   "
135155|NCT01515774|"     1. In order to observe the benefit, side effects, and patient preference of Mirapex ER when          used in once-daily (QD) or twice-daily (BID) dosing        2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER   "
135156|NCT01515761|"     The primary objective is to determine if lead positioning in the lateral wall of the left     ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in     determining myocardial function and affects the severity of mitral regurgitation.   "
135157|NCT01515748|"     Primary Objective:      - To compare progression free survival (PFS) in the two treatment arms      Secondary Objectives:        -  Overall survival (OS)        -  Postoperative stage and R0 (complete) resection rate        -  Safety: Toxicities associated with neoadjuvant chemotherapy, surgery,          morbidity/mortality, toxicity of adjuvant chemotherapy1   "
135158|NCT01515735|"     To evaluate the association profiles of the lysyl oxidase-like 1 gene polymorphisms with     pseudoexfoliation syndrome in the Korean population, Genotypes of lysyl oxidase-like 1 gene     were analyzed by direct sequencing.   "
135159|NCT01515722|"     Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the     medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to     improve treatment outcomes      Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance     and persistence, thereby can improve the treatment outcomes in conjunction with     pharmacological therapy in OAB patients      Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals   "
135160|NCT01515709|"     Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems,     particularly in their legs which makes them more limited in what they can do. The Short     Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed     and ability to stand from a chair. The SPPB may be a useful measure to predict leg function.      This study aims to evaluate whether the SPPB is comparable with current exercise tests used     in COPD patients, and whether it is useful in predicting disability, death and health     resource usage over time.   "
135161|NCT01515696|"     Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be     applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect     otherwise radiologically invisible perforations or an insufficient GIT anastomosis after     surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a     strong osmotic effect and leads to water influx into the intestine lumen. Thereby the     peristaltic movement is accelerated and the premature infant excretes stool during the hours     following application. Therefore Gastrografin might be effective to mobilize meconium from     small bowel and deep parts of the colon. The investigators hypothesized that enteral     application of Gastrografin accelerates meconium evacuation in premature infants, and thereby     enhances feeding tolerance in this population.   "
135163|NCT01515670|"     The purpose of the study is to determine the influence of preoperative co-morbidity in     relation to increased length of stay and postoperative complications in patients receiving     fast-track hip or knee replacement.   "
135166|NCT01515631|"     Patients who have Alagille Syndrome (AGS) also frequently have blockages (or stenoses) of     their pulmonary arteries. Little is known about the degree or variability of these stenoses,     or the effect of this disease on the right ventricle (the chamber of the heart which pumps     blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in     patients with Alagille Syndrome. The study will also assess the effect of these stenoses on     the right ventricle. The investigators hope to learn the degree and characteristics of     pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the     effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille     Syndrome. This information is critical in the management of patients with Alagille syndrome,     as there is currently no data to guide clinicians on the management of pulmonary artery     stenosis. Furthermore, the information from this study may help physicians manage pulmonary     artery stenosis in other patients as well.   "
135167|NCT01515605|"     Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue     from patients after kidney transplantation. In the present study the investigators examine     the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after     transplantation.      Routine clinical and laboratory data from serum and urine are evaluated at baseline and after     0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation.     Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes     (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting     T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase),     TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential     cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated     gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3),     MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using     standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques.     Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected     genes are analyzed using standard techniques. Data are analyzed by descriptive statistics.     Differences between groups were analyzed using Mann-Whitney test or Kruskal-Wallis-test and     Dunn`s multiple comparison post-test, as appropriate. Associations between variables are     analyzed using regression analyses. Contingency tables are analyzed using Fisher's exact     test.   "
135168|NCT01515592|"     This trial is conducted in Japan. The aim of this trial is to assess the safety and     tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.   "
135169|NCT01515579|"     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the     phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7     (formulation 3).   "
135170|NCT01515566|"     The goal of this clinical research study is to learn if fentanyl given under the skin can     reduce shortness of breath in cancer patients. Researchers also want to learn if it can help     to improve your physical function. In this study, fentanyl will be compared to a placebo.      Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with     their shortness of breath as well.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
135171|NCT01515553|"     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the     phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned     for phase 3b trials (final formulation 4).   "
135172|NCT01515540|"     The investigators tested whether pain decrease can be observed centrally with non-invasive     brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of     5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of     Lidocaine versus Placebo patches. Three time points were evaluated: baseline (before     treatment) and 6 hours and 2 weeks after treatment. The latter trial was a 2 arm, double     blind, placebo controlled trial, where participants either received Lidoderm or placebo     patches, without cross over.   "
135173|NCT01515527|"     The goal of this clinical research study is to learn if cladribine given in combination with     low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML     or MDS. The safety of this drug combination will also be studied.      Cladribine is designed to interfere with the cell's ability to process DNA (the genetic     material of cells). It can also insert itself into the DNA of cancer cells to stop them from     growing and repairing themselves.      Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing     and repairing themselves.      Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.   "
135174|NCT01515514|"     The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to     endoscope in comparison to standard free-hand image acquisition.   "
135175|NCT01515501|"     Patients undergoing routine rectal suction biopsy will undergo as part of the study an     additional Endoscopic mucosal resection. The biopsy results will also be correlated with     patient's clinical data including clinical history, Bristol stool scale, anorectal manometry     results, and SITZ marker studies. Cost and recovery time will be compared.   "
135176|NCT01515488|"     An audio-assisted self-triage kiosk in the Pediatric Emergency Department (ED) is expected to     significantly reduce triage times, without any sacrifice of the quality of information that     would be obtained by nurse-initiated triage.   "
135177|NCT01515475|"     The purpose of this study is to compare visual acuity outcomes and development of strabismus     after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia     (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only     after confirmation of pre-specified deterioration criteria.   "
135180|NCT01515436|"     The purpose of this study is to determine if having children listen to the music of Wolfgang     Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike     discharges on his/her Electroencephalography (EEG). These spike discharges often occur during     a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal     Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike     discharges after listening to Mozart's music, this information may lead to new understanding     and possible treatments for epilepsy.   "
135181|NCT01515423|"     The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation     (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the     treatment of patients with schizophrenia who have been stabilized on PP1M.   "
135182|NCT01515410|"     The primary objective of this study is to explore the efficacy and tolerability of DM-1992     compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as     measured by:        -  ON time with no dyskinesia or non-troublesome dyskinesia        -  OFF time   "
135183|NCT01515397|"     The aim of volume replacement is to compensate a reduction in the intravascular volume e.g.     during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital     functions. To achieve this, different plasma substitutes are available: Albumin, dextran,     hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base     alterations during elective abdominal surgery can be reduced by the use of a new gelatine     solution.   "
135184|NCT01515384|"     The purpose of this study is to evaluate the safety and pancreas imaging properties of     18F-AV-133.   "
135185|NCT01515371|"     The purpose of this study is to identify out of up to three doses a safe and effective dose     of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring.   "
135186|NCT01515358|"     The purposes of this study are to determine the safety and side effects of LY3000328, to     determine how well the body will tolerate LY3000328, and to determine how long LY3000328     remains in the body.   "
135187|NCT01515345|"     The purpose of this study is to determine the efficacy and safety of a routine individualized     antiplatelet therapy after coronary stent implantation by evaluating on-treatment platelet     reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).   "
135188|NCT01515332|"     This study is simply to test the repeatability of the indirect calorimetry instrument the     investigators use for our clinical studies.   "
135189|NCT01515319|"     Obesity causes 600 premature deaths per week in the UK and existing treatments are not     effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream which     make people feel full and which stop eating. One of these chemicals is known as Peptide YY     (PYY). The investigators have previously shown that injections of PYY reduce appetite and     food intake in human volunteers. The investigators have now developed a very similar     chemical, Y242, as a treatment for obesity. Y242 has been tested in animals and has been     shown to be safe, to reduce their appetite, and to last for much longer than PYY itself. This     study will test Y242 to ensure that it is well tolerated in humans, and to see how long it     lasts in the blood stream after being injected under the skin. It will also look for any     effects on appetite.   "
135190|NCT01515306|"     The purpose of this study is to investigate whether there are no clinically significant     pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating     the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors.      Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B) to     affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the     pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.   "
135191|NCT01515293|"     The aim of this study is to compare the short-term outcomes of single-incision and     conventional laparoscopic appendectomy.   "
135192|NCT01515280|"     The aim of this study is to have those patients taking part in the Clinical trial-: A     Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of     Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire     (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment     period. The investigators hope to demonstrate a clinically significant change in HARQ scores     of at least 16 points from before and after treatment. Furthermore the investigators would     hope to show a significantly improved HARQ score in patients on the BC036 arm of the study     compared to the placebo arm.   "
135193|NCT01515267|"     Left ventricular ejection fraction (EF) is evaluated in every echocardiographic examination     either by visual estimation (eyeballing) requiring high level of training and expertise     and/or by manual tracing of the endocard from which EF is calculated (manual biplane method     (MBP)). This procedure is subjective and time consuming. The objective of this study is to     compare the performance of LVivoEF software system to the measurements obtained by the     routinely used methods.   "
135194|NCT01515254|"     In this study the investigators will examine the Feeding Dynamic Intervention (FDI) as a tool     to prevent obesity in young children. The purpose of the intervention is to improving     caregiver feeding practices, child eating behaviors, and child self-regulation of energy     intake in the short term.   "
135195|NCT01515241|"     Despite the availability of several classes of very effective drugs available to treat     heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need     for new, effective and well tolerated therapies. There are a number of therapies given on a     chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty     acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but     subjects with heterozygous Familial Hypercholesterolemia remain at high risk for     cardiovascular events. There is still a need for acute therapies that can lead to rapid     pacification of unstable plaque in order to reduce the risk of these events. This study will     assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of     atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and     intravascular ultrasound (IVUS) evaluations in patients with HeFH.   "
135196|NCT01515228|"     The purpose of this study is to examine the safety and effectiveness of coronary stenting     with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic     patients.   "
135236|NCT01514708|"     The purpose of this study is to evaluate the antibody response to the influenza vaccine     (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in     pregnant women in compliance with the requirements of the current European Union (EU)     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed     flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.   "
135237|NCT01514695|"     The purpose of this study is to determine whether conscious sedation with a narcotic and     sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy     to achieve optimal patient comfort and ease of procedure.   "
135197|NCT01515215|"     Major Depressive Disorder (MDD) is one of the most prevalent mental illnesses in North     America, in which 30% - 40% fail to respond to conventional treatment. Repetitive     Transcranial Magnetic Stimulation (rTMS) has been shown to be an effective therapeutic tool     for the treatment of MDD. This form of treatment involves a series of magnetic pulses     directed to the brain for about 30 minutes. Importantly, such treatment is very safe and well     tolerated. However, to date, most treatment studies show modest efficacy due to limitations,     including: 1) treatments that are delivered to only one side of the brain; 2) treatment that     does not directly target a specific brain region associated with depression; 3) treatments     that are of short duration; 4) treatments that are of insufficient intensity; and 5)     insufficient understanding of the brain mechanisms responsible for therapeutic effect. This     study is designed to directly address all of these limitations, as well as explore brain     mechanisms (e.g. cortical excitability) through which treatment is optimized.   "
135198|NCT01515202|"     The purpose of this clinical study is to assess the safety and tolerability of multiple oral     doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes     Mellitus.   "
135199|NCT01515189|"     The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will     extend the lives of subjects with unresectable or metastatic melanoma more than giving     Ipilimumab at a dose of 3 mg/kg   "
135200|NCT01515176|"     This phase I/II trial studies the side effects and the best dose of ofatumumab and dinaciclib     and to see how well they work in treating patients with relapsed or refractory chronic     lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia.     Monoclonal antibodies, such as ofatumumab, can find cancer cells and help kill them.     Dinaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving ofatumumab together with dinaciclib may kill more cancer cells.   "
135201|NCT01515163|"     The investigators hypothesize that a three-month aerobic exercise training program will     positively affect the lipid profile, insulin sensitivity , cytokine profile, the     cardiovascular parameters and muscle strength in SLE patients.   "
135202|NCT01515150|"     Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated     diverticulitis has a very low risk (1.4%) of developing severe complications such as     perforations or abscesses. The question is whether or not hospitalization is necessary, and     if patients in that case could return home without antibiotics.      The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic     diverticulitis is possible without readmission or complications.   "
135203|NCT01515137|"     This trial was originally designed and powered to compare biomarker modulation in the     neo-adjuvant setting (erlotinib versus erlotinib plus sulindac versus placebo) with clinical     response to erlotinib in the adjuvant setting. Since implementing the trial in late 2005, The     investigators have encountered significant obstacles to implementing the adjuvant therapy     phase of the trial.        -  Barriers included:             1. disease recurrence             2. patient refusal to take the agent             3. patient refusal to travel to Pittsburgh for clinical evaluations.      Given the institutional challenges to implement and complete the adjuvant portion, the     investigators have decided to change the primary endpoint to a biomarker modulation endpoint.     To achieve this goal, the investigators determined that they needed 39 paired tissue     specimens (see statistical justification below).      The central hypothesis to be tested in this study is that persistent activation of parallel     and/or downstream pathways contributes to tumor progression in the setting of EGFR blockade.     While not all head and neck squamous cell carcinoma (HNSCC) patients will respond to EGFR     targeting, the optimal strategy to identify those subjects whose tumors are sensitive to EGFR     inhibition remains unknown.      The primary objective is centered around the concept of tumor biomarkers which may be     modulated by EGFR and Cox-2 inhibitors and may serve as future therapeutic targets for     therapy. To this end patients on this trial will be randomly assigned to one of three arms to     receive either Tarceva, Tarceva plus sulindac, or a placebo in the 2 week pre-operative     period. A panel of biomarkers will be obtained by biopsy prior to pre-operative therapy and     again at surgery. Biomarkers will be examined for modulation in the 2-week pre-operative     period, for group differences, for treatment effects and for further understanding of protein     signaling pathways.      Sample size for the primary objective      Modification of Statistical Design:      The primary endpoint is the difference between pre (biopsy) and post (surgery). There are 3     hypotheses of interest: (1) placebo vs erlotinib alone, (2) placebo versus erlotinib plus     sulindac, and (3) erlotinib vs erlotinib + sulindac. With a randomization in a 3:5:5 ratio,     we have 88% power, alpha = .01 for an omnibus test to show between-group differences of 1 log     exist. This requires 39 patients. Basically, 39 patients will provide the ability to detect a     one log difference between any 2 of the 3 groups in pre-post change.   "
135204|NCT01515124|"     WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer     survivors who are overweight or obese with breast cancer related lymphedema. There will be     four groups in this trial: exercise only, weight loss only, exercise and weight-loss     combined, and a control group. The purpose of this study is to test the effects of these     interventions on lymphedema outcomes, breast cancer recurrence and quality of life.      The cost analysis sub-study - will assess the cost-effectiveness of conducting the WISER     Survivor interventions and also model the impact of the WISER Survivor interventions over an     extended time frame.   "
135205|NCT01515111|"     A national cross-sectional survey was conducted to evaluate recommendations on clinical     preventive services and additional information on non-communicable disease prevention.     Trained surveyors interviewed interns, residents and attendings of the Internal Medicine     departments of all teaching hospitals in Guatemala. Analysis compared recommendation     practices within and between hospitals.   "
135206|NCT01515098|"     Purpose: The purpose of this study is to examine the effect of blueberry consumption on     cognitive decline and body composition in humans.      Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an     improvement in cognitive abilities as measured by a standardized battery of tests, relative     to those who consume a placebo.      Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an     increase in processing speed and an improvement in memory abilities as measured in an     electrophysiological paradigm and compared to those who consume a placebo.      Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition     (fat mass vs. lean mass).      Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress     and inflammatory markers.   "
135207|NCT01515085|"     Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or     radiation give patients a beneficial increase in overall survival? Laser induced thermal     therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of     heat.   "
135235|NCT01514721|"     The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav®     (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination     pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled     intraocular pressure (IOP).   "
135208|NCT01515072|"     The purpose of this study is to determine whether application of lower limb remote ischemic     preconditioning (RIPC) after determination of brain death improves donor stability, organ     quality, organ yield, and early post transplant clinical outcomes.      Neurological death donors will be stratified into standard and extended criteria donors     (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is     the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state,     donor organ-specific function parameters, pulsatile perfusion parameters, number of organs     transplanted per donor, recipient hospital free survival and delayed graft function of     kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.   "
135209|NCT01515059|"     It is well established that bariatric (weightloss) surgery affords considerable improvement     in glycaemic control (control of blood sugar), and in many cases may lead to a complete     resolution of type 2 diabetes. However, the mechanisms underlying these changes are yet to be     elucidated and no research project to date has attempted to characterise changes in glycaemic     control sooner than 3 days post surgery.      The primary objective of this study is to characterise changes in glycaemic control in     individuals immediately following such surgery for a period of five days. Participants will     be fitted with a continuous blood glucose measurement system (CGMS) prior to leaving theatre,     which electronically records their blood glucose concentration every minute for up to five     days. Upon returning the device each participant will undergo a standard meal test and have a     small blood sample taken at 30 minute intervals (0-120 minutes) for the quantification of     incretins (gut hormones involved in medium term control of blood sugar) insulin, glucose and     appetite hormones.      These measurements will be compared to those collected at the baseline session, three weeks     prior to the patient's surgery. Additional baseline visit measurements include: fasting lipid     profile, insulin concentration, blood glucose concentration, HBA1C (long term blood glucose     measurement), blood pressure, height, weight, waist circumference, and an oral glucose     tolerance test (OGTT) and medical and family history.      All patients will be followed up twelve weeks post surgery, during which, all baseline     measurements will be repeated.   "
135210|NCT01515046|"     This is a phase II study. It is designed to provide information about if high-dose ascorbate     (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin     C is well tolerated and increases cancer treatment effectiveness, lengthening survival time     for patients with advanced pancreatic cancer.   "
135211|NCT01515033|"     The purpose of the present study was to evaluate: 1) the effects of continuous exercise     training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2)     response during graded exercise test in patients with coronary artery disease; and 2) examine     the effects of exercise training modalities on the association among PETCO2 at ventilatory     anaerobic threshold (VAT) and indicators of ventilatory efficiency and cardiorespiratory     fitness in patients with coronary artery disease.   "
135212|NCT01515020|"     Hypothesis: The use of daptomycin to treat nosocomial or healthcare-associated bacteremia due     to methicillin-resistant S. aureus (MRSA) would increase the proportion of patients whose     blood cultures are sterilized after 72 hours by 15% relative to vancomycin and would improve     treatment safety.      Hypothesis: for MRSA nosocomial or healthcare related bacteriemia treatment, the use of     daptomycin versus vancomycin would increase by 15% the proportion of patients with sterilized     blood cultures at 72 hours and would increase the treatment safety.      Primary objective: To study the efficacy of daptomycin compared to vancomycin on the     sterilization of blood cultures after 72 hours of therapy.   "
135213|NCT01515007|"     The DRCFI treatment will influence the time to first pulmonary exacerbation compared to     placebo.   "
135214|NCT01514994|"     The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase,     observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring     Balloon Catheter for the treatment of critical aortic valve stenosis.   "
135215|NCT01514981|"     The purpose of this study is to determine that no significant safety issues will be     identified following a single dose of AMG 761 in asthma subjects that would preclude further     development of AMG 761.   "
135216|NCT01514968|"     This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect     of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy     volunteers. Subjects will be randomized to one of two treatment sequences to receive a single     oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single     oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.   "
135217|NCT01514955|"     Main cause of mortality in cervix cancer is local relapse in the pelvis. Since distant     metastasis is quiet rare, increasing local control in the pelvis can directly translate into     improvement in survival. Obstacles in front of this approach is the dose limitation to normal     organs located in the pelvis adjacent to the tumor. 3-D MRI based EBRT and Brachytherapy will     grant safe delivery of more conformal higher doses of radiation to the tumor and allowing     sparing of the normal structures.   "
135218|NCT01514942|"     Insulin resistance has important implications in the pathogenesis of the polycystic ovary     syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.      Reduction of insulin levels with administration of insulin sensitizing agents has been found     to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring     ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely     used in the long term treatment of women with PCOS in whom it modifies the ovarian     morphology, improves intraovarian androgen levels, and enhances systemic and local insulin     resistance. Despite to these beneficial effects, several side effects have been reported due     to the long term administration of this drug.      In the recent years, inositol has found more and more space in the reproductive clinical     practice. Indeed, inositol have been classified as insulin sensitizing agent and it is     mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in     particular several studies on Myo-inositol and D-chiro-inositol were reported.      In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in     women with PCOS and with or without insulin resistance.   "
135219|NCT01514929|"     The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the     QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase     in the QT interval.   "
135220|NCT01514916|"     The medical device Vascular Join represents a new anastomotic technology that should reduce     the inter-surgeons variability in anastomosis construction and increase the performances in     terms of results. It allows a perfect mechanical anastomosis without suture, avoiding the     disadvantages of operation length and difficulty of the act, thrombosis, clamping and     embolism. The Vascular Join creates automatically the connection between the vein or     prosthesis at both ends and bridging the artery while preventing the passage of the needle     and suture through the vessel wall and clamping pressure. This makes it very easy to     construct a vascular anastomosis using the endoscopic technique less traumatic for the     patient, lessen the pain of the patient, thereby reducing health care costs by reducing the     length of hospital stay.      No part of the device is in contact with the patient's blood because the whole system remains     in the thickness of the arterial wall and outside the vessel. Thus, the formation of intimal     hyperplasia is greatly diminished and the risk of occlusion of the anastomosis is less than     the currently available risk when a suture is used. This risk is shown by studies on animals     in labs, with a mean follow up of 12 months. The Vascular Join creates a perfect congruence     of anastomosed vessels because it allows a perfect match between each vascular tunic.      The medical device Vascular Join has been designed in order to:        -  Reduce the suture time;        -  Reduce the risk of occlusion of vein after the surgical process;        -  Avoid the contact risk between the external material steel (surgical needle) and blood;        -  Standardize the quality of anastomoses independently of the skill of the surgeon.   "
135221|NCT01514903|"     This is a single dose open-label comparative pharmacokinetic study to assess the     pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra     (tablet) in healthy male subjects.   "
135222|NCT01514890|"     The purpose fo the study is to evaluate the efficacy defined by the sustained virological     response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and     telaprevir or boceprevir in the French Early Access Program for the use of protease     inhibitors or after the approval of these drugs through the the marketing authorization.   "
135223|NCT01514877|"     The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT     in treating patients with multiple brain metastases from NSCLC.   "
135224|NCT01514864|"     The purpose of this study is to establish whether patients with malignancy harboring a     discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to     dasatinib.   "
135225|NCT01514851|"     To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum     Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized,     double-blind, parallel group study in comparison with Calcium carbonate.   "
135226|NCT01514838|"     The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C     as well as its safety in Asian subjects with type 2 diabetes mellitus.   "
135227|NCT01514825|"     The purpose of this study is to evaluate the safety and plasma concentration change of YM150     after repeated administration to healthy elderly male and female subjects.   "
135228|NCT01514812|"     This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in     healthy subjects.   "
135229|NCT01514799|"     Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is     not always enough. Bypassing a longer segment of the gut may be more beneficial. Which part     to bypass is not clear.      The investigators want to compare the effects between preventing a proximal (oral) portion of     the jejunum from food contact with the effects when preventing the jejunum from contact with     bile and pancreatic juice.      Endpoints are quality of life, gstrointestinal function, and weight development.   "
135230|NCT01514786|"     Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of     multiple competing demands. A decision aid (DA) that clarifies patient preferences and     improves decision quality could aid shared decision making (SDM) and be effective at     increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year     R01 study funded by the National Cancer Institute seeks to provide detailed understanding of     how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS     adherence.   "
135231|NCT01514773|"     To better understand the reasons for underutilization of defibrillator therapy in selected     populations, the investigators propose a study to assess heart failure patient knowledge and     attitudes toward device therapy. By carefully studying populations of patients with systolic     heart failure, the investigators aim to identify the underlying reasons for implantable     cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic heart     failure.   "
135232|NCT01514760|"     Investigators from University of Arkansas for Medical Sciences Department of Pediatrics and     University of Arkansas for Medical Sciences Center for Distance Health will collaborate to     develop a mobile-based Asthma Action Plan application to improve asthma self-management     skills specifically targeting adolescents. The investigators hypothesize that an interactive,     mobile-based asthma action plan will be a feasible means of reinforcing long-term asthma     management guidelines as well as delivering acute management instructions to adolescents with     asthma.   "
135233|NCT01514747|"     Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the     US. These babies often have motor and/or visual problems when they grow up. It is very     important to identify high risk ELBW infants as early as possible, so that the investigators     can treat them earlier to prevent poor development. Neurological examination at early age is     not good enough to identify high risk ELBW infants. One the other hand, some magnetic     resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state     functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and     visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at     a very early age to predict long−term outcome and to identify infants who are at high risk of     having motor and/or visual problems when they grow up.   "
135234|NCT01514734|"     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®     from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular     hypertension.   "
135259|NCT01514396|"     The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™     Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure     of the topical skin in children presenting in the Emergency Department (ED).   "
135238|NCT01514682|"     Despite current antipsychotic treatment, the majority of people with schizophrenia continue     to exhibit persistent positive and negative symptoms and cognitive impairments. An     alternative approach to the use of psychotropic agents for the treatment of persistent     symptoms is the use of anti-inflammatory agents to reverse the pro-inflammatory state     hypothesized to underlie the symptom and sign manifestations of the illness.      The investigators primary hypothesis is that add-on anti-inflammatory combination therapy     will have significant beneficial effects on persistent positive symptoms and cognitive     impairments.      The investigators secondary hypotheses are:        1. add-on anti-inflammatory combination therapy will be associated with improvements in          depressive and negative symptoms and a reduction in pro-inflammatory cytokines        2. add-on anti-inflammatory combination therapy compared to placebo will not be associated          with elevated adverse risk.   "
135239|NCT01514669|"     The purpose of this research study is to compare profiles in the blood and tears of patients     with and without prostate cancer with the goal of developing a method of separating men with     aggressive and non-aggressive disease.   "
135240|NCT01514656|"     Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival     for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than     one third of witnessed SCA events. A number of barriers to bystander CPR training have been     identified including time and cost of the training course. Since the large majority of arrest     events occur in the home environment, studies have suggested that providing CPR training to     family members of hospitalized cardiac patients may serve as a useful approach to address an     environment in which bystander CPR is frequently not provided. Utilizing an existing     in-hospital program to train adult family members, the investigators will assess the skills     of those who learn CPR through two different education methods (video-only and video     self-instruction (VSI) kit).   "
135241|NCT01514643|"     The purpose of the study is to investigate a relationship between the inflammatory response     following intraarticular fracture and post-traumatic osteoarthritis. The investigators plan     to evaluate the inflammatory cytokine profile in knee joint synovial fluid and blood serum in     patients who sustain an intraarticular tibial plateau fracture and ankle joint synovial fluid     and blood serum in patients who sustain an intraarticular tibial plafond fracture. This     information will be combined with radiographs and patient outcome measures to determine a     correlation between intraarticular inflammatory response and post-traumatic osteoarthritis.   "
135242|NCT01514630|"     Methamphetamine (MA) is a psychostimulant drug with high abuse potential. MA can be smoked,     snorted, injected or ingested orally to produce a release of high levels of dopamine into the     brain and reduction of dopamine uptake. Its use results in feelings of pleasure, increased     energy, and greater alertness lasting up to 12 hours. In 2010, the National Survey on Drug     Use and Health reported that 353,000 Americans aged 12 or older reported being current MA     users. Over the past decade MA use rates have fluctuated with current use rates on the     decline; however, importantly, even though overall use rates are declining, use rates among     males and females are approaching equal proportions. This use rate pattern is unlike other     drugs of abuse, which typically demonstrate males using more than females. In some states,     more females than males consider MA as their drug of choice. Namely, in a 2010 report in the     state of Utah, more females were diagnosed with MA as a primary substance of abuse than males     upon admission to treatment.      Depression and MA use are highly comorbid. The relationship between MA use and depression is     likely bidirectional, with MA use causing changes in mood and being used as a self-medicating     behavior to reduce symptoms of depression. Several studies have shown that depression rates     are higher in MA-using females compared to their male counterparts. It is likely that     neurobiological and psychosocial mechanisms contribute to increased incidence of depressive     symptoms in females.      No clear treatment model exists to suggest how the comorbidity of depression and MA use is     best managed. In studies of antidepressants for treatment of MA withdrawal and dependence,     findings have suggested that antidepressants are ineffective for treating depressive     symptoms.      Creatine is an organic acid occurring naturally in vertebrates, where it takes part in energy     homeostasis in tissues with fluctuating energy demands. Exogenous creatine has been shown to     increase brain concentrations of PCr. Neuroimaging studies of creatine have shown increased     brain phosphocreatine (PCr) content with creatine administration. Therefore, we hypothesize     that oral creatine administration will increase PCr levels and reduce depressive symptoms in     a sample of depressed female MA users. This hypothesis will be tested by a within subjects     design by giving depressed MA using females oral creatine for eight weeks and measuring PCr     pre- and post-treatment with magnetic resonance spectroscopy. Moreover, depressive symptoms     will be measured by administration of the Hamilton Depression Rating Scale twice weekly     during the course of creatine treatment.   "
135243|NCT01514617|"     It is known that volumetric response of leiomyomas following uterine artery embolization     correlates well with patients clinical outcome. The aim of this study is to assess diffusion     -and perfusion weighted MRI for the prediction of volumetric response following uterine     artery embolization in patients with symptomatic leiomyomas.   "
135244|NCT01514604|"     Constructing a learning curve in ultrasound guided needling      Observational study - How many attempts, with continuous training and feedback, at in-plane     ultrasound guided needling in a phantom model are required to attain competence?      The use of ultrasound to enable real-time needle visualisation during regional anaesthesia     (placing local anaesthetic, via a needle, near nerves to result in numbing of an area of the     body to be operated on) has gained in popularity in recent years. It has been recognised by     NICE (National Institute for Clinical Excellence) and guidelines on training have been     published, with UK equivalents pending. These call for training in the technique on models or     'phantoms' prior to patient contact.      It is unknown how much experience is necessary to attain competence in a phantom, prior to     proceeding to patient contact. One study looking at experiential learning of the technique     found a very wide range of experience needed between individuals.      In order to study the effect of any changes in training methods on the learning of the     technique it is necessary to have a baseline learning curve.      The investigators are introducing a training package for anaesthetists new to the technique     to meet the recommendations on initial phantom based training. Alongside this the     investigators aim to gather prospective observational data allowing the investigators to     generate a learning curve for the technique. This involves making a video recording of the     ultrasound images of approximately 50 sequential attempts at performing a task in a phantom,     with ongoing instruction and coaching. The whole training package will take approximately 1     hour.      These video clips will be reviewed and sequential attempts graded for quality of needle     visualisation and task completion. This will allow the investigators to use a statistical     method, Cumulative Sum (Cusum) analysis, to determine how many attempts were required to     attain proficiency. The investigators hope to recruit approximately 20 participants to this     pilot study, and from this determine the average amount of training necessary to attain     proficiency. Using Cusum analysis requires the use of an acceptable failure rate, usually     chosen arbitrarily. To add greater meaning to our findings the investigators will also invite     anaesthetists experienced in the technique of in-plane ultrasound guided needling to     participate. By measuring the actual success rate of our local trainers the investigators     will be able to make a meaningful comparison of the training required to achieve a similar     level of success.   "
135260|NCT01514383|"     The purpose of this study is to evaluate how surgical adhesive is used.   "
135245|NCT01514591|"     The purpose of the study is to assess the coagulation changes that occur in laboring patients     undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We     will compare coagulation data to assess potential coagulation changes associated with     hemoglobin changes before and after surgery, and related to estimated blood loss.   "
135246|NCT01514578|"     This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception     and sedation in healthy adult males.   "
135247|NCT01514565|"     This is a prospective observational study aimed to validate biomarkers that predict response.   "
135248|NCT01514552|"     In areas of the world where populations are undernourished poor oral health is prevalent.     Diets rich in fruit and vegetables are thought to have many health benefits including     reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries     contain many different compounds which may be responsible for these proposed health benefits.      From this study, the researchers hope to gain information about how the tissues in the mouth     absorb strawberry gummies in a population of habitually smoking and never smoking men and     women. The researchers will measure inflammation hormones in your saliva and urine and the     genes in your mouth and blood. Two different strawberry gummies will be tested in this study.     The strawberry gummies were developed at OSU in the Department of Food Science and     Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while     the other type will have no fruit. In total the eight pieces of strawberry gummies that you     will consume in one day will be at most equal to 1 cup of whole strawberries. The research     team believes the two strawberry gummies may be digested and absorbed differently and that     components in the strawberry gummies may be helpful for oral health.   "
135249|NCT01514539|"     Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies     suggest that childbearing is an important contributor to the development of obesity in many     women and that breastfeeding may be protective.      Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy     homeostasis and are biological neuroendocrine signals that potentially affect body weight and     adiposity/   "
135250|NCT01514526|"     -  Design: non-randomized, open label, phase II clinical trial.        -  Study population and disease: adult patients with metastatic or locally advanced          non-resectable adrenocortical carcinoma, confirmed histologically.        -  Estimated number of patients: 15.        -  Study drug: dovitinib (TKI-258), dosed on a flat scale of 500mg/day on a 5 days on / 2          days off.        -  Treatment duration: study treatment period will be continued until disease progression,          unacceptable toxicity, death or premature withdrawal from study. An average of 6 months          treatment period is expected.        -  Study duration: expected recruitment period will be 18 months, and patients will be          followed for 6 additional months after last patient is included in the trial.Study total          expected duration is 24 months.        -  Sites: the study is planned to be conducted in 7 Spanish centers.   "
135251|NCT01514513|"     The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in     eradicating head lice as compared to Nix, both are available over-the-counter lice     treatments.   "
135252|NCT01514500|"     This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability,     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the     effect of the investigated drug on the body) of NNC0195-0092 compared to placebo in healthy     male subjects.   "
135253|NCT01514487|"     This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence     between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase     3 formulation at pH 7.7.   "
135254|NCT01514461|"     The purpose of this study is to determine whether LCQ908 is effective and safe in lowering     triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia     [HLP] type I). Data from this study will be used to support a registration submission of     LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).   "
135255|NCT01514448|"     Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with     sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was     evaluated in these patients.   "
135256|NCT01514435|"     There exist already a few studies that have measured changes of brain metabolism pre and post     Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all     performed in a small number of patients and used different methodologies. It is therefore not     surprising that these investigations provided inconsistent results, as reviewed previously     {{23 Schmidt,E.Z. 2008}}.      In patients with treatment-refractory major depressive episodes, the investigators here     therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur     after treatment with ECT and (b) whether these correlate with the clinical amelioration of     symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive     function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at     the end of treatment.      Patients with a treatment refractory depression - defined as absent clinical improvement of     depressive symptoms after at least two trials with antidepressants from different     pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30     Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively     asked for participation in this study. Patients had to be between 18 and 80 years old and to     be physically healthy.   "
135257|NCT01514422|"     The purpose of this study is to evaluate minocycline as a potential treatment for bipolar     depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is     approved for the treatment of infections and acne. Participation in this research study is     expected to last 8 weeks, and includes five outpatient visits.   "
135258|NCT01514409|"     5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and     is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter     that is involved in the regulation of mood.      Previous research has assessed the effects of raising serotonin levels using tryptophan (the     precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy     volunteers. However, to date there has been no human trial investigating the effects of 5-HTP     on emotional processing in healthy volunteers.      Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and mood     in healthy volunteers.   "
135261|NCT01514370|"     This is a prospective, monocentric, double blind, placebo controlled, two arm study.      Curcumin is derived from the rhizomes of the plant Curcuma longa (common name, turmeric)     belonging to the Zingiberaceae family found in South Asian countries, especially India which     is the largest producer. BCM95 (bioCurcumin) is a combination of a Curcumin extract and oil     to enhance the bio-absorbability in humans. BCM95 may enhance and prolong the antioxidant and     anti-inflammatory effects of the standard therapy maintaining a good safety profile.   "
135262|NCT01514357|"     The aim of this study is two fold: First the investigators want to determine the safe and     most effective dose of subcutaneous (SQ) BNP in subjects with resistant hypertension. Second,     the investigators want to demonstrate efficacy of chronically (one week) administered SQ BNP     in resistant hypertension in reducing blood pressure.   "
135263|NCT01514344|"     Phase II, monocentric, open label study to assess safety and activity of intralesional     Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.   "
135264|NCT01514331|"     The main purpose of this study is to investigate effects of SIMV+VG (synchronized     intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support     ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation     synchrony, ventilation parameters and inflammatory mediators in neonates.   "
135265|NCT01514318|"     The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data     on patients who received the Revelation Hip Stem prior to 2002.   "
135266|NCT01514305|"     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System     when used as an adjuvant to blood glucose testing.      Device performance will be primarily evaluated in terms of the proportion of glucose values     within a pre-specified range compared to reference values.      Safety data of the G4 System will also be collected vis-a-vis adverse event reporting     characterized by the incidence and severity of Serious Adverse Device Events, and Adverse     Device Events experienced by study participants.   "
135267|NCT01514292|"     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System     when used as an adjuvant to blood glucose testing over a 7-day period in people >18 years-old     with diabetes mellitus.      The primary objective is to characterize the System performance with respect to laboratory     reference venous sample measurements. The device performance will be primarily evaluated in     terms of point and rate accuracy of the G4 System in reference to YSI.      Safety of the G4 System will be characterized by Adverse Device Effects and Serious Adverse     Device Effects experienced by study participants.   "
135268|NCT01514279|"     The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health     (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood     Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case     Western Reserve/Cleveland's project is entitled Targeting Obesity and Blood Pressure in     Urban Youth. The site name is IMPACT (Ideas Moving Parents and Adolescents to Change     Together).      The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight     and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a     systems improvement intervention (SystemsChange), and an education-only intervention     (Tools4Change). In addition the study assesses the potential additional impact of a     school-community based intervention on outcomes.      The project has two phases: a formative phase (including focus groups and a pilot) and the     main trial. The main trial will take place over approximately four years.   "
135269|NCT01514266|"     Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and     health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason     for deterioration of lung function in COPD. Currently there is no medication available that     can modify or reduce this inflammation. Furthermore, from literature review it has been shown     that chronic inflammation can result in cancerous changes.      Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress     the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down     regulated by this substance. This study was designed to evaluate effect of combination of     curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized     pilot study.   "
135270|NCT01514253|"     Glucose has analgesic and calming effects in newborns. To date, it is not known whether the     beneficial effects extend to care giving procedures that are performed after painful     procedures. The investigators objective is to determine the effect of glucose 25% analgesia     in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a     subsequent care giving procedure.   "
135271|NCT01514240|"     The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily     compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's     disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of     180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after     8-week treatment defined by a CDAI score of ≤ 150.   "
135272|NCT01514227|"     NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet     Therapy (DAPT) following Nobori stent deployment.   "
135273|NCT01514214|"     Strictures in the bile duct cause a blockage of flow of bile. This leads to potential     problems including jaundice, itch and infection in the bile duct. The usual first step in     this situation would be to allow flow of bile by placing a stent across the stricture. This     is usually done by a special type of endoscopy procedure called an endoscopic retrograde     cholangiopancreatography, or ERCP.      The most commonly used stent are made from a plastic material called polyethylene and has a     central lumen in which bile drains through it. Health Canada has approved the sale and use of     another stent with a winged perimeter (the VIADUCT stent) for placement in bile duct     strictures and is used routinely in our hospitals. However, the investigators do not know     which stent is better at treating bile duct strictures. In order to determine which stent     would be more useful, the VIADUCT stent and the usual polyethylene flanged stent must be     studied under carefully controlled circumstances. This will be done by a randomized,     subject-blinded study. Other trials in the past have looked at other stents in this way, but     this is the first time the VIADUCT stent has been looked at in this manner. The investigators     suspect that the design of the VIADUCT stent will allow it to work for a longer period of     time compared to the traditional polyethylene stent.   "
135288|NCT01514019|"     An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the     effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and     pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers   "
135507|NCT01511133|"     This study aims to test the clinical samples (stool and serum) previously collected during     clinical development of HRV vaccine, to identify if there is any evidence of PCV-1     replication and/or immune response to the PCV-1 in vaccinated infants.   "
135274|NCT01514201|"     This phase I/II trial studies the side effects and the best dose of veliparib when given     together with radiation therapy and temozolomide and to see how well they work in treating     younger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growth     of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses     high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide,     work in different ways to stop the growth of tumor cells either by killing the cells or by     stopping them from dividing. Giving veliparib with radiation therapy and temozolomide may     kill more tumor cells.   "
135275|NCT01514188|"     This is a phase 2b, randomized, open-label, prospective, multicenter study comparing     treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or     unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy     except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor     recurrence has occurred for at least 12 months.   "
135276|NCT01514175|"     The primary objective of this study is to compare the efficacy of a single dose of     intravenous ibuprofen compared to a single dose of ketorolac for the treatment of     postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).   "
135277|NCT01514162|"     To further evaluate the long term clinical safety and effectiveness of the Trifecta valve   "
135278|NCT01514149|"     DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly     injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.   "
135279|NCT01514136|"     Coloplast A/S has developed a new ostomy device in 8 versions.      The primary objective of this investigation is to assess and compare the degree of leakage     when using the 8 different devices.      The secondary objective is to investigate several performance and safety parameters of the     various devices.      The aim of the primary and secondary objectives is to acquire more knowledge about the     performance of the newly developed device and inspiration for their further development, if     needed.      Given that the investigation is exploratory, pass/fail criteria are not relevant. The     investigation result will provide knowledge useful for continued decision-making/device     development.      The investigation is designed as a non-blinded, controlled, exploratory investigation that     includes a total of 30-40 Danish ileostomy users.      Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each     device will be tested for 7 (± 2) days.   "
135280|NCT01514123|"     This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100     alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study in     subjects with advanced or metastatic solid tumors. The study is aimed at evaluating the     safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100     when administered alone or in combination with bevacizumab.   "
135281|NCT01514110|"     The purpose of this study is to determine dose limiting toxicities (DLT) and maximum     tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.   "
135282|NCT01514097|"     Pain is a common cause for children seeking care in the Emergency Department (ED). Children     with orthopedic injuries often require pain control when seeking emergency care. Despite the     high prevalence of ED visits requiring pain control, pain is often poorly assessed and     treated in ED settings. Currently, no standard of care exists for the management of this     fracture-related pain in children discharged from the ED. Furthermore, discrepancies in     analgesia administration to patients of various racial groups seeking emergency care have     been documented but are poorly understood. No research currently exists comparing pain     severity between upper extremity fractures requiring simple splinting to those treated with     sedated reduction and splinting. Furthermore, there is no research regarding the prevalence     of significant post-discharge pain nor the differences among ethnic and age groups treated in     the ED.      Research Questions:      What is the prevalence of significant post-discharge pain in children treated for upper     extremity fractures?      Is there a difference in severity between those children requiring reduction versus simple     splinting?      Is there a difference in pain severity noted among different ethnic or age groups?      Design This is a prospective, un-blinded, observational study that will include patients     seeking treatment for an upper extremity fracture.   "
135283|NCT01514084|"     Facial lacerations are commonly treated in the emergency department. The nature of the injury     leads to a great deal of concern about the long-term cosmetic appearance of the wounds.      Research Questions        1. What is the association between wound characteristics, wound management in the ED,          patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured wounds?        2. Is there a difference noted among ED providers with different levels of training?        3. Is there an association between initial satisfaction scores and wound outcome?        4. Is there an association between short term and long term wound scores?      Design This is a non-randomized, prospective, observational study of patients who present to     the ED seeking treatment for facial laceration repair.   "
135284|NCT01514071|"     It is difficult for Pediatric Emergency Department providers to recognize clinically     significant head injuries that are likely to require neurosurgical intervention or close     monitoring from those that can be safely discharged.      Research Question How do a combination of education and an animated picture depicting the     PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT     scans?      Design This is a within subject, repeated measures study design.   "
135285|NCT01514058|"     Patients who present with obstructive jaundice due to a malignant stricture often undergo a     battery of tests for diagnosis, treatment options, and prognosis. An endoscopic retrograde     cholangiopancreatography (ERCP) is often performed with biliary stent placement for symptom     relief as well as brushings for cytology. An endoscopic ultrasound is performed as well for     fine needle aspiration (FNA) of the pancreas to aid in diagnosis. However, since EUS is not     available at many centers, patients often undergo an initial ERCP procedure with stent     placement (which is more widely available) prior to referral for EUS. It has been reported     that biliary stents can disturb EUS visualization due to inflammation, acoustic shadowing,     and pneumobilia which may lessen the accuracy of diagnosis.1 The cytological yield from the     EUS with FNA procedure may also be compromised in patients with biliary stents. As such,     diagnosis and treatment options may be delayed. One retrospective study of 65 subjects showed     a significant difference in the number of correctly staged pancreatic head cancers (mainly T     stage) in patients without stents versus those with biliary stents (85% vs 47%).2 A second     retrospective study concluded that tissue diagnosis is not influenced in patients with stents     placed greater than 24 hours before the EUS; however, patients with stents placed just prior     to the EUS (less than 24 hours) were more likely to have indeterminate results.1 Although the     findings are suggestive, the studies are limited by their retrospective design and these     questions have not yet been addressed in a prospective study.      Both procedures require anesthesia, and when performed sequentially in the same setting, the     duration of anesthesia is prolonged. This is concerning for the patient since complications     may theoretically increase with prolonged anesthesia. However, a retrospective review at a     tertiary referral center showed that combined EUS and ERCP yielded a complication rate no     higher than that of the component procedures.3      At our institution, the current practice is to sequentially perform both EUS and ERCP in the     same setting for patients with suspected malignant biliary obstruction. Typically, EUS-FNA is     performed first, followed by ERCP.      Hypothesis We hypothesize that performing ERCP with biliary stenting immediately prior to     EUS-FNA will decrease the diagnostic yield of EUS-FNA and diminish the ability of EUS to     accurately stage pancreas tumors. Conversely, performing EUS-FNA prior to ERCP will increase     biliary cannulation time and increase success rate.      The objectives of this study are as follows:        1. Determine the diagnostic yield of EUS-FNA (for diagnosis of cancer vs benign process)          when performed either immediately before or after ERCP with biliary stenting (primary          outcome)        2. Determine the ability of EUS to accurately stage pancreatic masses (T and N staging)          when performed either immediately before or after ERCP with biliary stenting (secondary          outcome) in comparison to the gold standard of surgical pathology post resection or in          comparison to CT findings (in those patients who are not surgical candidates)        3. Determine the biliary cannulation time (the time it takes to successfully pass a wire          into the common bile duct from the start of the procedure) and success rate of placing a          biliary stent during ERCP when performed either immediately before or after EUS-FNA          (secondary outcome)   "
135286|NCT01514045|"     The Gastric Cancer Registry will combine data acquired directly from patients with gastric     cancer via an online questionnaire with genomic data obtained from blood and tissue samples.     The purpose of this registry is to gain better understanding of the causes of gastric cancer,     both environmental and genetic; whether certain genomic data can predict outcomes of     treatment and survival; as well as explore the issues that effect the quality of life of     these patients after diagnosis and treatment.   "
135287|NCT01514032|"     The purpose of this study is to compare two established modalities for the treatment of     kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with     stone-extraction). Comparison of the stone-free rates 3month postoperative.        -  Trial with surgical intervention   "
146730|NCT01363687|"     The purpose of this study is to investigate whether upper limb ischemic postconditioning can     improve renal function and decrease ischemic-reperfusion injury in patients undergoing living     donor kidney transplantation.   "
135289|NCT01514006|"     The purpose of this study is to evaluate the possible association between postoperative     anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.      The investigators hypothesise that patients with a higher degree of postoperative anaemia     have impaired postoperative rehabilitation as measured by standardized functional outcome     tests.   "
135290|NCT01513993|"     The purpose of this study is to evaluate whether telemonitoring of patients with chronic     heart failure produces a reduction in the combined end point of all cause mortality and     number of hospitalisations, and whether it improves health related quality of life. In     addition, the trials evaluate the economic and organisational impact of the telemonitoring     service and examine its acceptability by patients and health professionals.   "
135291|NCT01513980|"     The purpose of this study is to evaluate whether the introduction of large-scale     telemonitoring of patients with COPD produces benefits in terms of improved health-related     quality of life and reduced access to hospital facilities. In addition, the trial evaluates     the economic and organisational impact of the new services, and examine their acceptability     by patients and health professionals.   "
135292|NCT01513967|"     This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to     investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study     will be divided into three parts: A, B, and C   "
135293|NCT01513954|"     The purpose of this study is to determine whether progesterone hormone levels differ     following egg retrieval with a single lumen needle compared with a double lumen needle. These     levels will be measured on several days before and after egg retrieval. The progesterone     levels in each IVF group will also be compared to the group of women who are having IUI. In     addition, these progesterone levels will be correlated with pregnancy outcomes.   "
135294|NCT01513941|"     The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given     with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of     hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human     immunodeficiency virus (HIV-1).   "
135295|NCT01513928|"     This study is designed to compare the pharmacokinetics of three different formulations of     Pf-04937319   "
135296|NCT01513915|"     The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention for     children with anxiety disorders (AD) is undeniable. However, most children with AD have     limited access to CBT. There is some controversial evidence on group CBT in AD involving     families in treatment of their children and a published article on efficacy of a parent only     group CBT for these children. Considering these data, the investigators hypothesized that     teaching anxiety-fighting skills to parents of children with AD would diminish anxiety     symptoms of both parents and children and improve family relational functioning.   "
135297|NCT01513902|"     Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than     18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).   "
135298|NCT01513863|"     The objective of this study is to demonstrate that metronidazole 1% topical gel is effective     for the treatment of patients with moderate to severe rosacea.   "
135299|NCT01513850|"     The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a     study drug) after liver transplantation.   "
135300|NCT01513837|"     Based on the evidence for the common pathway in asthma presentation, our working hypothesis     is that asthma severity and lack of control are related to the prevalence and severity of     nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal     polyps.   "
135301|NCT01513824|"     The purpose of the study is to examine if bio feedback guided stress management by daily     measurement of pressure pain sensitivity followed by acupressure reduces signs of depression     and number clinical stress signs and increases quality of life in patients with stable,     ischemic heart disease   "
135302|NCT01513811|"     Bowel preparation is a major determinant of colonoscopy and colorectal surgery. Polyethylene     glycol electrolyte solutions (PEG-E) are the most commonly used laxatives in China. However,     a significant number of patients, especially those constipated patients, failed colonoscopies     due to poor bowel cleaning. Inadequate preparation may also lead to missed colonic lesions.     The study is based on the hypothesis: itopride hydrochloride, a prokinetic agent, its dual     role as dopamine D2 receptor antagonism and acetylcho-linesterase inhibition make it an     appropriate adjuvant for bowel preparation. It was reported to promote colonic peristalsis,     shorten colonic transit time and accelerate propulsion of colonic luminal contents through     inhibition of M3 receptor and dopamine D2 receptors in vitro and in vivo. So this study is to     determine the efficacy, tolerance and safety of high dose of itopride, when given in     different times before administration of PEG-E, for colonic preparation in patients with     chronic constipation.   "
135303|NCT01513798|"     The investigators investigate if combined progressive aerobic training and resistance     training improve metabolic control and fat mass in patients with type 2 diabetes who are     eating a modified paleolithic diet. The investigators randomize 40 participants to two     groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2)     Modified paleolithic diet and general advice about exercise.      The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat     mass more with progressive exercise under observation and a modified paleolithic diet than     with general advice about exercise and a modified paleolithic diet.   "
135343|NCT01513265|"     The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP     = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP =     Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the     drug use in elderly inpatients.   "
135360|NCT01513044|"     An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,     crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's     Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in     healthy, adult,human, male subjects under fasting conditions.   "
135448|NCT01511900|"     The primary objective of the study is to evaluate the safety of escalating multiple doses     over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).      Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of     escalating multiple doses of CAT-1004 in patients with T2D.   "
135304|NCT01513785|"     The efficacy of traditional triple therapy has been decreased to such an unacceptable level     as 70% in many areas. The study is based on the hypothesis: the most important factors which     influence the effect of Helicobacter pylori (H. pylori) eradication included acid suppression     intensity and sensitivity of antibiotics. So the investigators chose dual therapy because it     is simple and verified to be useful. Rabeprazole, as a new proton pump inhibitor (PPI), is     reported to be less susceptible to the influence of genetic polymorphisms for CYP2C19. So it     has a greater and faster acid suppression effect compared to other PPIs. Amoxicillin is one     of effective antibiotics to H. pylori with few side effects. The antibiotic resistance of     Amoxicillin is no more than 3% in China. The purpose of our trial is to evaluate and compare     the efficacy and safety of dual therapy regimens with different doses of Rabeprazole for     initial treatment of H. pylori infection.   "
135305|NCT01513772|"     The investigators examined the effect of dexmedetomidine on the emergence agitation and     postoperative quality of recovery in nasal surgery   "
135306|NCT01513759|"     The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used     in conjunction with recombinant t-PA as a treatment for acute pulmonary embolism (PE) will     decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients with massive or     submassive PE.   "
135307|NCT01513746|"     The purpose of the study is to investigate how people with type 1 diabetes experience and     manage their diabetes, eating, and weight. Summary of the Study: If you choose to     participate, you will complete a set of questionnaires and a structured interview. You will     then wear a continuous glucose monitor and use your cell phone to answer study questions for     a period of 3 days. The questions come in the form of regular phone calls between the hours     of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also     be asked to call in and answer study questions at other times during the day, especially     after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live     greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype.     Participants will receive and return study materials through the mail.   "
135308|NCT01513733|"     The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel     is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies,     cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes     the backbone upon which to improve upon. Thus, the primary objective of this study is to     determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone     based on safety and tolerability in men with chemorefractory metastatic castration-resistant     prostate cancer (CRPC).   "
135309|NCT01513720|"     This is an single dose,two-way, crossover, oral bioequivalence study.   "
135310|NCT01513707|"     This is a prospective, multicenter, comparative, parallel-group, observational study. There     will be 2 cohorts according to pre-transplant dialysis modality (hemodialysis or peritoneal     dialysis). In each cohort, subjects will be observed for 12 months. Approximately, 1040     subjects will be enrolled from 8 transplant centers.      Subjects will be enrolled consecutively until the number of subjects in peritoneal dialysis     group has been 260. It will take 2 years. In this period, the number of subject in     hemodialysis group enrolled in this study will be 780. After finishing the observation of all     subjects, to balance clinical and demographic baseline characteristics between the two     groups, subjects will be selected in each cohort with 1:1 matched using propensity score     method. And then primary and secondary endpoints will be compared between two groups.   "
135311|NCT01513694|"     The purpose of this trial is to test the effectiveness of the use of a new therapeutic     strategy in treating patients with degenerative disc disease lumbar intervertebral fusion     with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium     phosphate ceramic (Conduit TM).   "
135312|NCT01513681|"     This is an single dose,two-way, crossover, oral bioequivalence study.   "
135313|NCT01513668|"     The purpose of this study is to compare single-dose oral bioavailability of acetaminophen 650     mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA     (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650     mg) of Mc Neil, Consumer & Specialty Pharmaceuticals, U.S.A in healthy, adult, male human     subjects under fed condition.   "
135314|NCT01513655|"     Background: In chronic obstructive pulmonary disease, the prognosis for patients who have     survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor.     Despite being shown to improve survival and quality-of-life in stable patients with chronic     hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in     unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory     failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic     respiratory failure, treated with noninvasive ventilation, we have been able to reduce     mortality and the number of repeat respiratory failure and readmissions by continuing the     acute noninvasive ventilatory therapy as a long-term therapy.      Methods: Multi-center open label randomized controlled trial of 150 patients having survived     an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure     due chronic obstructive pulmonary disease. The included patients are randomized to usual care     or to continuing the acute noninvasive ventilation as a long-term therapy, both with a     one-year follow-up period.      End points: The primary endpoint is one-year mortality; secondary endpoints are time to death     or repeat acute hypercapnic respiratory failure, number of readmissions and repeat acute     hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung     function, and arterial gases.   "
135315|NCT01513642|"     Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac     surgery patients, the breath-stacking technique has been proposed as an alternative to     increase pulmonary volumes in the post-operative period.      Objective: To compare inspiratory volume and electromyographic activity of respiratory     muscles during breath stacking technique and incentive spirometry in patients undergoing     cardiac surgery.   "
135316|NCT01513629|"     Autism spectrum disorders (ASD) is a highly hereditary neuropsychiatric disorder. In children     and adolescents worldwide, the prevalence of ASD is estimated at 0.6%. Understanding the     biological mechanism of this disorder could potentially facilitate prompt, accurate and     personalized therapy. The dysfunction of fronto-temporal circuitry may explain language     impairment in ASD. In addition, pieces of evidence suggest that the abnormality of the     cortico-striato-thalamic circuitry might be related to social deficits. However, very little     is known how changes in these two circuitries are related to variation in genotypes. Previous     reports on ASD using magnetic resonance imaging (MRI) have demonstrated alteration of brain     structure. Recent advance in neuroimaging has shown that structural connectivity of a     specific circuitry is superior to regional analysis in terms of higher penetrance of genetic     effects and better account for behavioral variance. Therefore, it is plausible that     connectivity imaging may serve as effective endophenotypes that link clinical manifestation     (phenotypes) and the biological variables (genotypes). In the past five years, our lab has     established world leading diffusion spectrum imaging techniques, and applied the techniques     to clinical studies on ASD, schizophrenia, stroke and epilepsy. The clinical experience and     technical strengths provide a strong basis for us to extend to imaging genetics, aiming to     determine effective endophenotypes of ASD. Therefore, the goal of this project is to validate     structural connectivity of fronto-temporal and cortico-striato-thalamic circuitries as     effective imaging endophenotypes of ASD. Specifically, the investigators will achieve the     goal through a series of validation. First, the investigators will demonstrate that     structural connectivities in the two targeted circuitries are indeed different among groups     of patients with ASD, unaffected siblings, and neurotypicals. Second, the investigators will     demonstrate in neurotypicals and unaffected siblings that the altered structural     connectivities related to social and language impairments are indeed different in carriers of     risk genes, i.e. CNTNAP2 and SLC25A12, respectively. Last, the investigators will demonstrate     in all participants that the altered structural connectivities are associated with the     corresponding behavioral variances in social and language function. This two-year project is     a cohort study consisting of three groups, namely patient, unaffected siblings, and control     groups matched in age, gender and handedness. The patient and sibling groups consist of 20     boys each, age 10-15 years old, and the control group consists of 40 boys. The examination     includes behavior assessment (IQ test, neuropsychological and clinical assessment), MRI study     (structure MRI and diffusion spectrum imaging for structural connectivity) and genome     scan(specifically candidate genes related to language function, i.e. SLC25A12, and to social     function, i.e. CNTNAP2). In conclusion, this is the first cohort project on imaging genetics     in Taiwan. The success of this project will facilitate the progress of translational     neuroscience in Taiwan. The methodology of validating endophenotype will be readily extended     to other psychiatric diseases.   "
135359|NCT01513057|"     An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,     crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's     Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in     healthy, adult, human, male subjects under fed conditions.   "
135317|NCT01513616|"     Dyspnea (respiratory discomfort) and activity limitation are the most common symptoms of     chronic obstructive pulmonary disease (COPD) and contribute importantly to a perceived poor     quality of life. Recent international guidelines have stressed the importance of dyspnea     alleviation and improvement exercise tolerance as a means of enhancing quality of life and     other long term outcomes in this population. Modern pharmacotherapy is the first step in     symptom management but the overall impact of bronchodilator therapy is relatively small.     Exercise training remains the most effective treatment for ameliorating dyspnea and improving     exercise endurance and was the main focus of this study.      The main objectives of the study were:        1. To conduct and compare detailed studies of respiratory mechanics during cycle exercise          before and after exercise training (EXT) compared with an untrained control group. By          multiple regression analysis, the investigators will establish the main contributors to          dyspnea relief after EXT.        2. To compare the magnitude of change in endurance during constant work rate cycle exercise          with those measured during walk tests and the endurance shuttle walk test after EXT          relative to control. To evaluate which test (constant work rate cycle, six-minute walk          test, or endurance shuttle walk test) is the most sensitive test for measuring changes          in endurance after EXT versus control.        3. To compare the change in standardized dyspnea ratings (Borg Scale) during constant-load          cycling with a variety of other activity-related dyspnea questionnaires. To evaluate          which of these measurements is the most sensitive for examining changes in perceived          discomfort during exercise.        4. To evaluate the contribution of psychological factors (anxiety, fear, respiratory panic,          self-efficacy) to the perceived improvement of symptoms following EXT. The investigators          will use multiple regression analysis to examine associations between changes in          perceived dyspnea and changes in anxiety and self-efficacy measured by validated          questionnaires and Borg intensity ratings?   "
135318|NCT01513603|"     CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents     is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the     efficacy of the regimen in patients with relapsed ALL.   "
135319|NCT01513590|"     This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the     efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart     30) in insulin naïve subjects with type 2 diabetes.   "
135320|NCT01513577|"     Convalescence after lumbar surgery is dependent on the extensiveness of the surgical     procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve     excellent clinical results with less pain, morbidity and disability.   "
135321|NCT01513564|"     Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery     accelerated stay programs with optimized pain management enhance recovery.      The objective is to evaluate the effect of a revised and optimized perioperative fast track     program in lumbar fusion surgery.   "
135322|NCT01513551|"     The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia     disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal     Polysaccharide Vaccine (Pneumovax 23) and 13-valent Pneumococcal Conjugate Vaccine (Prevnar     13) when administered to healthy adults 50 years of age or older.   "
135323|NCT01513538|"     The technological progress allowed the development of more and more sophisticated pacemakers,     widening the therapeutic indications but also meeting the physiological needs of the patient.     This progress led to a more and more complex programming for the physicians. To help them set     optimally the pacing parameters, physicians refer to the existing recommendations of learned     societies as well as to his expertise. Manufacturers developed also algorithms integrated     into pacemakers with the aim of assisting physicians in their programming.      TherapyGuide is a function which proposes a programming adapted to the psychopathological     state of the patient, with a justification based on experts' consensus, clinical studies as     well as on published articles.      Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When     rejected, there is no means to analyze the modifications brought to the proposed set of     parameters. The nature, the frequency and the reasons of these modifications are not thus     known.      The purpose of this study is to assess the acceptance of the TherapyGuide proposals by     physicians and to identify the most frequent type of programming changes they make and their     rationale.   "
135324|NCT01513525|"     This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic     profile of liraglutide between administrations in the thigh versus the abdomen and between     administrations in the upper arm versus the abdomen.   "
135325|NCT01513499|"     Exciting advances have led to the concept that hormones can modulate appetite and food     intake. Oxytocin is a peptide hormone that is released in regions throughout the brain,     including areas involved in food motivation. Animal studies suggest that oxytocin may reduce     food intake. The effects of oxytocin administration on eating behavior in humans, which could     have important implications in eating-related disorders ranging from obesity to anorexia     nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of     single-dose oxytocin administration investigates whether:        1. Caloric intake will decrease following administration of oxytocin versus placebo        2. Appetite will decrease following administration of oxytocin versus placebo        3. Resting energy expenditure will increase following administration of oxytocin versus          placebo   "
135326|NCT01513486|"     In the present study, the effects of 5 days of lower limb immobilization with or without     daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics     will be determined.   "
135327|NCT01513473|"     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).      The aim of this trial is to investigate the efficacy and safety of insulin degludec in     children and adolescents with type 1 diabetes mellitus.   "
135328|NCT01513460|"     This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium     when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary     disease.   "
135341|NCT01513291|"     The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo     for preventing migraines in participants with episodic migraine. After a 28-day Screening     period during which baseline number of monthly migraine days was assessed, participants were     randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who     completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2     weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the     initial randomization. In the Run-out Period, participants who received placebo in the     Treatment Period continued to receive placebo and participants who received MK-6096 in the     Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested     in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as     measured by the mean change from baseline in monthly migraine days averaged over the 12- week     treatment period.   "
135342|NCT01513278|"     The standard treatment for early-stage breast cancer is breast-conserving surgery followed by     adjuvant radiation therapy to the whole breast. This approach leads to low recurrence rates     with a good cosmesis and provides an effective alternative to mastectomy. However, in most     women receiving radiotherapy radiation dermatitis occur to some degree.      Radiation dermatitis generally manifests within a few weeks after the start of radiation     therapy. Its onset varies depending on the radiation dose intensity and the normal tissue     sensitivity of individuals. As the cumulative dose of radiation increases the transient     erythema occurring during the first weeks of radiotherapy may evolve into the more persistent     erythema and to dry or even moist desquamation that reflects the damage to the basal cell     layer and the sweat and sebaceous glands.      There is currently no evidence that prophylactic treatments, beyond keeping the irradiated     area clean and dry, are effective in reducing the incidence or severity of radiation     dermatitis (Bolderston et al. 2006).      However, together with other enzymes of the peroxidase pathway, SOD scavenges the superoxide,     hydroxyl, and other oxygenated free radicals (Klug et al. 1972; Tainer at al. 1983). In     physiological conditions, the production of free radicals (Monte & Sacerdote 1994) and the     action of antiradicals' enzymes is balanced. Following tissue injuries, either pathological     or caused by agents such as radiation therapy, an excess production of free radicals is     observed (Petkau 1986; Lorette & Machet 2001). Furthermore, basal SOD is increased in breast     cancer patients before radiation therapy as compared to controls (Seth et al. 2003), and     decreases after radiotherapy (Ray at al. 2000). Hence, liposomal rhSOD applied during     radiotherapy could be used to prevent the effects of free radicals and thus might protect the     patient's skin from radiation-induced skin reactions.      TREATMENT PLAN All patients receive APN201 and placebo at the same time. The irradiated     region is divided vertically into two symmetric areas (left and right). One area is treated     with APN201, the other area is treated with placebo in a double-blind fashion.      Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and     continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to     a total dose of 50.0 Gy or 50.4 Gy, respectively) (see schedule of assessments, section 5.1).      Study treatment is stopped if radiation dermatitis of ≥ grade 2 occurs in one or both treated     areas for ≥ 3 days AND a difference in the severity of radiation dermatitis of ≥ 1 grade is     seen between the two treated areas. From that point in time the patient only receives the     treatment that appeared to be beneficial and this treatment is applied to the whole     irradiated region until completion of the 25th, respectively 28th, fraction.      Treatment stops earlier in case of progressive disease or unacceptable toxicity or     intolerability.   "
135373|NCT01512875|"     The objective of this study is to elucidate the role of drinking water derived from the     public source in Lima, Peru and transmission of H. pylori infection using genotypic     techniques.   "
135329|NCT01513447|"     For most women, the most significant pain they will experience is the pain associated with     childbirth. Up to one-third of women experience back labor, this typically occurs when the     fetus assumes varying degrees of malposition, especially the occiput posterior position, and     causes additional constant pressure against the maternal spine and pelvis. Back labor     presents as constant pain, that occurs even between contractions. It is often difficult to     manage, by the patient, the obstetrician, and the anesthesiologist, and may increase the rate     of instrumental and caesarian delivery.      Epidural anesthesia/analgesia is the most common and effective intervention used to help     women cope with labor pain. Dilute concentrations of local anesthetic and opioid provide     complete analgesia for most women. Some women, however, have breakthrough pain, often due to     back labor, and require more concentrated drug solutions. This increases the side effects     associated with these drugs (e.g., hypotension, pruritus, motor block), thus treatment of     this pain poses a challenge for the anesthesiologist and the obstetrician.      Sterile water injections (SWI) are a simple and well-established method of managing labor     pain among midwives. This intervention was first used to alleviate pain associated with     kidney stones, and was introduced to obstetrics in the 1970s. Using a syringe, small amounts     of sterile water is deposited subcutaneously near the sacral area. The sterile water causes     osmotic and mechanical irritation resulting in a brief (15-30 second) and significant     stinging sensation. The onset of pain relief follows almost immediately and may last for up     to two hours. The procedure can be repeated a number of times.      Sterile water for pain management is most often administered using four intracutaneous     injections: two sites lateral to the lumbosacral spine and two sites 2-3 cm below and 1-2 cm     medial to the original two injection sites. 0.1 mL of sterile water is injected between the     dermal layers to raise a small bleb on the skin surface at each of the four sites. In labor,     the injections are administered sequentially during a uterine contraction, with the series of     four injections, performed two at a time, completed within 20-30 seconds.      The investigators hypothesize that the use of sterile water injections in women with     neuraxial analgesia with breakthrough pain will result in decreased local anesthetic     requirements and increase patient satisfaction.   "
135330|NCT01513434|"     The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has     been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these     methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study     is not easily available nor an in vivo test. The purpose of this study is to compare the     position of the femoral tunnel aperture on conventional MRI and the outcomes after single     bundle ACL reconstruction using free tendon Achilles allograft between transportal technique     and transtibial technique in active young men.   "
135331|NCT01513421|"     The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to     surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill     patients, this procedure allows to avoid or postpone surgery. In these settings, the     percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no     prospective trials has assessed the efficiency of these two modalities of drainage in cases     of infected intra-abdominal collections. The investigators aimed then to prospectively     analyzed the efficiency (in term of infectious control) of drainage under active vacuum     pressure vs. free drainage for the treatment of infected intra-abdominal collections.   "
135332|NCT01513408|"     Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer,     and makes it possible to evaluate tumour response. Achieving pathological complete response     (pCR) after chemotherapy is the most important prognostic factor for these patients. However,     patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not     achieve pCR is poorly documented, and no specific prognostic factors have been clearly     identified.Preclinical and clinical studies argue for an immunogenic role of some     chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating     recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence     antitumour immune response, partially contributing to efficacy. Conversely, tumours can     promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour     immune response, and increased numbers of regulatory T-cells are associated with less     favourable prognosis in breast cancer patients. We have previously shown that a high number     of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry     on surgical specimens, is associated with better response and better survival in breast     cancer patients, independently of whether pCR was achieved, the type of chemotherapy used,     and the type of breast cancer. Therefore, we propose to validate in a prospective study this     immunological prognostic marker in a large cohort of patients treated with neoadjuvant     chemotherapy.   "
135333|NCT01513395|"     Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound     examinations and can impede accurate cervical length measurement and placental location     determination. The timing of bladder voiding is associated with the prevalence of focal     myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded     randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for     cervical assessment compared with no bladder voiding immediately before vaginal ultrasound in     order to determine the prevalence of focal myometrial contractions during vaginal ultrasound     cervical assessment and test whether timing of bladder voiding is associated with their     incidence.   "
135334|NCT01513382|"     Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.   "
135335|NCT01513369|"     The purpose of this study is to investigate the correlation between HbA1c and iron status in     Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron.   "
135336|NCT01513356|"     BKM120 is a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K)     inhibitor, currently under investigation in a first-in-man study in patients with advanced     solid tumors (wild type and PIK3CA-mutated). Consistent, dose-dependent pharmacodynamic     activity has been demonstrated and clear signs of anti-tumor activity have been seen with     BKM120.   "
135337|NCT01513343|"     The goal of this study is to develop and test the efficacy of a scientifically-based,     culturally competent seven-session parent directed, obesity prevention program focused on     parental feeding strategies that support young children's self-regulation of intake.   "
135338|NCT01513330|"     The purpose of the study is to evaluate leakage of a newly developed ostomy product compared     to standard care in subjects with colostomies. Subjects will be asked to use each test     product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show     that the newly developed ostomy product is significantly better to reduce leakage compared to     standard care.   "
135339|NCT01513317|"     The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a     reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic     Syndrome (MDS).   "
135340|NCT01513304|"     Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence     of parental bias in reporting crying behaviour.   "
135344|NCT01513252|"     The MAPT PLUS study is a two-year extension of follow-up of the patients included in the MAPT     preventive study, after completion of the interventions. Subjects in the four groups of the     MAPT study will be prospectively followed. MAPT is a multicentre, randomised,     placebo-controlled study, using a 4-group design with 3 treatment groups (omega 3 alone,     multi-domain intervention alone, omega 3 plus multi-domain intervention, n=420 each) and a     placebo group (n=420). The MAPT PLUS study will be an extension of the MAPT study and     includes an annual follow-up for two years.   "
135345|NCT01513239|"     MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A     (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with     MK-6072 or MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease     Clostridium Difficile Infection (CDI) recurrence compared with placebo; and 2) MK-6072 and     MK-3415A will be generally well tolerated in participants receiving SOC therapy for CDI     compared with placebo.   "
135346|NCT01513226|"     This study shows that cycled light during neonatal care reduces infant's fussing and crying     behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.   "
135347|NCT01513213|"     The purpose of this study is to evaluate whether a correlation exists between the partial     pressure of carbon dioxide existing within arterial blood and the gradient between inhaled     and exhaled fractions of oxygen.   "
135348|NCT01513200|"     This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12     healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered     together have any significant impact on the pharmacodynamic effects of UFH and the     pharmacokinetics of Bendavia.   "
135349|NCT01513187|"     Phase I / II, open, prospective, multicenter single-arm, Clinical Trial in two stages: in the     first stage it will determine the optimal dose of the combination of pazopanib and interferon     alfa-A2 in the treatment of patients with advanced renal carcinoma and a second stage that     will determine the efficacy of this combination measured in terms of response rate.   "
135350|NCT01513174|"     This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281)     versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation     positive advanced non-small-cell lung cancer.   "
135351|NCT01513161|"     The purpose of this study is to determine whether nalfurafine hydrochloride is effective and     safe in the treatment for conventional-treatment-resistant pruritus in patients receiving     hemodialysis.   "
135352|NCT01513148|"     The introduction of light emitting diode (LED) devices as a novel treatment for pain relief     in place of low-level laser warrants fundamental research on the effect of LED devices on one     of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized     controlled study will be conducted by measuring nerve conduction on the superficial radial     nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation     recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and     peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an     irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the     placebo group will be treated by sham irradiation. The purpose of this study is to     investigate the effects of LED light on the conduction velocity and amplitude of the     superficial radial nerve.   "
135353|NCT01513135|"     Tat is a key HIV regulatory protein produced very early after infection, prior to virus     integration, and necessary for viral gene expression, cell-to-cell virus transmission and     disease progression. Previous studies in natural HIV infection, indicated that the presence     of a Tat-specific immune response correlates with a lower incidence and reduced risk of     progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune     response to Tat may exert a protective role and control the progression to AIDS in vivo.     Moreover, Tat is conserved in its immunogenic regions (both B and T cell) among all subtypes.     subtypes. Recent data, in fact, indicate an effective cross-clade recognition of clade B     strain-derived (BH-10) Tat protein from the HTLV-IIIB lab-adapted virus strain (Buttò, 2003),     which was isolated about 30 years ago (Ratner, 1985), by sera from individuals infected with     viruses circulating at the present in Italy and in Africa, thus reflecting the high degree of     conservation of the corresponding Tat regions and providing strong formal evidence that a     Tat-based vaccine may indeed be used in the different geographic areas of the world, since it     is capable of inducing a broad immune response against different virus clades. Based on this     rationale and on the positive results of preclinical (Cafaro, Nat Med 1999) and phase I     preventive and therapeutic clinical trials with Tat protein (ISS P-001 and ISS T-001,     respectively) (Ensoli AIDS 2008, Vaccine 2009; Longo Vaccine 2009; Bellino RRCT, 2009) a     phase II therapeutic, open label, clinical study with Tat protein (ISS T-002,     ClinicalTrials.gov NCT00751595) was sponsored by ISS and activated in 11 clinical sites in     Italy in HIV-infected HAART-treated subjects (Ensoli F, Retrovirology 2015).In this study,     subjects are randomized into two arms to receive 3 or 5 vaccinations monthly; each arm is     composed of two treatment groups, receiving 7, 5 or 30 µg of Tat, respectively.Results     obtained in 168 individuals after trial completion (48 weeks), as well as after a follow-up     of 144 weeks for a subgroup of vaccines, indicated that Tat vaccination is safe, immunogenic     and capable of reducing the immune dysregulation which persists despite HAART in treated     individuals (Ensoli et al,PLoS ONE 2010). Anti-Tat Abs were induced in most patients (79%),     with the highest frequency and durability in the Tat 30 µg groups (89%) particularly when     given 3 times (92%) (Ensoli B.,PLoS ONE 2010; Ensoli F., Retrovirology 2015). Moreover,     vaccination promoted a durable and significant restoration of T, B, natural killer (NK)     cells, and CD4+ and CD8+ central memory subsets. Moreover, a significant reduction of blood     proviral DNA was seen after week 72, particularly under PI-based regimens and with Tat 30 µg     given 3 times (30 μg, 3x), reaching a predicted 70% decay after 3 years from vaccination with     a half-life of 88 weeks. This decay was significantly associated with anti-Tat IgM and IgG     Abs and neutralization of Tat-mediated entry of oligomeric Env in dendritic cells, which     predicted HIV-1 DNA decay. Finally, the 30 μg, 3x group was the only one showing significant     increases of NK cells and CD38+HLA-DR+/CD8+ T cells, a phenotype associated with increased     killing activity in elite controllers (Ensoli F., Retrovirology 2015). These data indicate     that Tat immunization represents a promising pathogenesis-driven intervention to intensify     HAART efficacy (Ensoli et al,PLoS ONE 2010).   "
135354|NCT01513122|"     The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside     reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and     in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis     are also common in HIV-infected patients. There appears to be some association between ART     and bone loss, but this is poorly understood and requires further research. The SECOND-LINE     study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in     greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently     standard of care. This study also provides an opportunity to examine if additional bone loss     occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART used     in second line therapy result in more or less bone loss than use of other classes of anti-HIV     drugs such as protease inhibitors or N(t)RTI combinations.      It is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater     increases in limb fat and smaller reductions in bone density at the proximal femur over 48     weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs).   "
135355|NCT01513109|"     The purpose of this study is to evaluate the safety and the efficacy of combined treatment     strategy of WT1ASCI, infusion of ex vivo regulatory T cells depleted T lymphocytes and in     vivo regulatory T cells depletion as post-consolidation therapy in patients with WT1-positive     Acute Myeloid Leukemia. The study will also evaluate the clinical activity and immune     response of this approach in bad risk patients in CR1 and all patients in CR2 or CR3, non     eligible for an allogeneic Hematopoietic Stem Cell Transplantation   "
135356|NCT01513096|"     In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were     proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included     in a few studies. The investigators study was to show that sufficient dosage of prokinetics     added to split dose of PEG improves the state of bowel preparation.   "
135357|NCT01513083|"     This open-label, parallel group study will evaluate the pharmacokinetics and safety of     trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or     reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1     of each 3-week cycle. Anticipated time on study treatment is until disease progression or     unacceptable toxicity occurs.   "
135358|NCT01513070|"     This study investigates the effective power of angina pectoris after Quick-Acting Heart     Reliever and isosorbide dinitrate interventing respectively the patients with moderate     coronary stenosis for six months. At the same time, the studying will assess the plaque,     myocardial blood-supplying,quality of life and observe the end point of the heart (including     the myocardial revascularization, death and myocardial infarction). The purpose is to study     the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever     for moderate coronary stenosis lesions.   "
135385|NCT01512719|"     POEM has recently described as an alternative treatment for achalasia in humans. In this     procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus.     In this study we aim to perform POEM on achalasia patients.   "
135361|NCT01513031|"     The purpose of this study is to determine if follow-up by a pharmacist over the telephone     improves adherence and short term clinical outcomes in the patient with atrial fibrillation     prescribed an oral anti-arrhythmic medication. This study will also identify the reasons     people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication     counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly     basis to assess adherence over one year.   "
135362|NCT01513018|"     The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High     tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery.     The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal     volumes on arterial oxygenation and Intrapulmonary shunt during OLV.      One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were     randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero     end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg     with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During     the subsequent 30 minutes, each patient received the alternative management. Minute volume     was thus kept constant during each experimental condition. Arterial blood partial pressures,     hemodynamic responses, and ventilatory parameters were recorded. Results are presented as     means ± SDs; P < 0.05 was considered statistically significant.   "
135363|NCT01513005|"     The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve     Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed     as a Day-Case surgery.   "
135364|NCT01512992|"     The purpose of this study is to assess the effects of a complex telemedicine intervention as     a part of an integrated care program for patients with chronic obstructive pulmonary disease     (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the     intervention produces benefits in terms of mortality, reduction in hospital readmissions and     health-related quality of life. In addition, the trial evaluates the economical and     organizational impact of the new service and examines its acceptability by patients and     health professionals.   "
135365|NCT01512979|"     The purpose of this trial is to determine whether a initial combination of linagliptin and     metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed,     treatment-naïve patients with Type 2 Diabetes.   "
135366|NCT01512966|"     This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF     Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.   "
135367|NCT01512953|"     This study aims to prospectively assess whether there is an interaction between genetic     status in terms of 2C19 activity and residual platelet reactivity after clopidogrel intake in     patients who underwent coronary stenting for elective, urgent or emergent intervention.   "
135368|NCT01512940|"     Various gastric restrictive procedures have evolved over the years but abandoned due to poor     long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic     gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done     as an alternative to the other restrictive procedures. But the short and long term safety and     efficacy outcomes of LGCP is not well documented in current literature. American society of     metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be     considered investigational at this time and should be performed under a study protocol with     third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to     review adverse events and outcomes.      The objective of this study will be to demonstrate feasibility , short term and long term     safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding     of stomach and thereby achieving good weight loss .   "
135369|NCT01512927|"     The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan are both the highest     worldwide from 2001 to 2008. In Taiwan, more than 90% of the ESRD patients are hemodialysis     patients. Either arteriovenous fistula (AVF) or arteriovenous graft (AV graft) is essential     for the vascular access of these patients. However, frequent AVF stenosis or thrombosis     occurs in 10-30% hemodialytic patients, and the rates are even higher, around 30-70%, in     those who has a past history of AVF/AV graft stenosis. Therefore, early detection of AVF     stenosis is essential in caring for these hemodialysis patients in terms of medical economics     and psychological impact. Unfortunately, angiographic study is expensive and invasive and     needs contrast medium injection. The diagnostic accuracy of color duplex ultrasound in AVF     stenosis remains satisfactory, but it is not always available when decreased AVF flow or an     acute thrombotic event occurs. Continuous AVF/ AV graft flow monitoring by patient himself is     a better option in terms of long-term care. Previous study indicated that stethoscope     waveform analysis could be used as an alternative to diagnosis of vascular stenosis.     Therefore, we aim to investigate AVF/ AV graft stenosis by using the electronic stethoscope     (3M Littmann) for AVF sound recording, followed by software analysis by using waveform     decomposition, principle component analysis (PCA) and sequential forward selection algorithm     [xx]. Our study results will provide a new diagnostic option, which is low cost, non-invasive     and self-monitoring, of AVF stenosis in ESRD patients.   "
135370|NCT01512914|"     Studies evaluating intraperitoneal local anesthetic instillation for pain relief after     laparoscopic procedures have provided conflicting results. This randomized, double-blind     study was designed to assess the effects of a novel intraperitoneal local anesthetic     administration technique using nebulization on pain relief after gynecologic laparoscopic     surgery.   "
135371|NCT01512901|"     This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for     macular edema following branch retinal vein occlusion   "
135372|NCT01512888|"     SCID-X1 is a genetic disorder of blood cells caused by DNA changes in a gene that is required     for the normal development of the human immune system. The purpose of this study is to     determine if a new method, called lentiviral gene transfer, can be used to treat SCID-X1.     This method involves transferring a normal copy of the common gamma chain gene into the     participant's bone marrow stem cells. The investigators want to determine if the procedure is     safe, whether it can be done according to the methods they have developed, and whether the     procedure will provide a normal immune system for the patient. It is hoped that this type of     gene transfer may offer a new way to treat children with SCID-X1 that do not have a brother     or sister who can be used as a donor for stem cell transplantation.   "
135374|NCT01512862|"     Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a     marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency     is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and     lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect     in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of     vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary     hyperparathyroidism in patients with advanced chronic kidney diseases.      Therefore, the objective of this study is to evaluate the anti-proteinuric effect of     calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and     placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function,     serum and urinary inflammatory markers, and adverse event will be monitored.   "
135375|NCT01512849|"     The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with     type 2 diabetes mellitus who have moderate renal impairment.   "
135376|NCT01512836|"     This randomized controlled trial (RCT) will examine a nurse case management model for     patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish     municipality, and is performed in order to evaluate the use of case management as a tool in     achieving integrated, quality and cost-effective care for this group of patients.      The main objectives are to evaluate how case management influences on hospital admissions,     mortality, quality of life and self care, as well as to compare costs and cost-effectiveness     of case management vs. usual care.   "
135377|NCT01512823|"     This pragmatic randomised controlled trial (RCT) used a two-group parallel design with     matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed     to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge,     skills and use at 12 weeks, and 2) to investigate the feasibility of conducting a RCT with     occupational therapists in a public health setting. Occupational therapists employed by the     Western Cape Department of Health (DOH) form,ed the study population(N=98). Fifty-eight     consented to participate and were randomly allocated to either an interactive (IE) or a     didactic (DE) educational intervention using coin tossing. Data was collected at baseline and     12 weeks The primary outcome was increased EBP knowledge at 12 weeks shown by an improved     total knowledge score. Secondary outcomes were improved attitudes and behaviour. Data were     collected at the health facilities where participants were employed. Raters for the audit     were blinded but participants and the provider could not be blinded.      Thirty participants were allocated to receive the IE and 28 the DE. Twenty-five participants     in the IE and 21 in the DE completed the trial and were included in the 12 week analysis.     Results revealed no significant difference between the groups in the primary knowledge     outcome at 12 weeks. Examination of within-group changes revealed significant improvements in     knowledge in both groups (IE: T=4.0, p<0.001; DE: T=12.0, p=0.002), but the IE also showed a     significant increase in behaviour (T=64.5, p=0.044) and attitudes on one sub-scale (T=33.0,     p=0.039). As the study was powered at 43%, it may have failed to detect significant     differences at 12 weeks. Conducting a high-quality RCT was feasible and the risk of bias was     assessed as low. The OTEBP trial adds strength to the existing evidence that both didactic     and interactive educational interventions can improve knowledge, but it seems that     interactive interventions may be more effective for changing behaviour. High-quality     pragmatic trials can feasibly be conducted within the public health service   "
135378|NCT01512810|"     Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical     staging for endometrial cancer increases operative time and surgical morbidity, but appears     to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic     approach has not been reproduced, and the investigators propose to validate their algorithm     at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary     data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the     investigators are well-suited to perform this investigation. A surgical approach that is     tailored to the patient's cancer biology is rational, supported by the recent literature, and     medically compelling since the co-morbidities of many obese, low-risk EC patients put them at     significantly increased perioperative risk for complete lymphadenectomy.   "
135379|NCT01512797|"     The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe     and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.   "
135380|NCT01512784|"     Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV     infection and the development of HPV-associated lesions in female and male anogenital tract.     Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in     HIV-infected population are few. The present study is a non-randomized controlled clinical     trial with the primary objective to determine safety ad immunogenicity of quadrivalent human     papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young     adults.   "
135381|NCT01512771|"     We hypothesize that prevention of Sleep Disordered Breathing among PTSD patients with nasal     CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use     alcohol to control their symptoms).   "
135382|NCT01512758|"     This is an open-label, multicenter, phase 1 study of alisertib in East Asian patients (eg,     patients from countries including but not limited to Singapore, Hong Kong, Taiwan, and South     Korea) with either relapsed or refractory advanced solid tumors or lymphomas for which no     effective standard treatment is available.   "
135383|NCT01512745|"     Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor     receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The     investigators' phase I study has shown that the drug's toxicity is manageable and the maximum     tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib     can improve progression free survival or overall survival compared with placebo in patients     with metastatic gastric carcinoma who failed two lines of chemotherapy.   "
135384|NCT01512732|"     Today, no non-verbal auditory stimuli that assess mental processing are available in Israel.     The goal of this study is to make available a validated set of auditory stimuli in Israel. We     created a computerized Hebrew version of the Montreal Affective Voices (MAV). The MAV is a     novel tool for assessing mental processing. The MAV consists of 90 nonverbal affect bursts     corresponding to nine different emotions (such as anger, fear, happiness etc.) recorded by     ten different actors. The uniqueness of these affective bursts is that they do not contain     verbal context, but rather express affective moods using the vowel /a/ (as in apple). In     this study, the investigators will verify the new Hebrew version of MAV in healthy control     groups. Next, the investigators will compare the mental processing ability in young vs. old     population, using the MAV test. In addition, the investigators will assess mental processing     in two pathologic study groups (Parkinson's disease, major depressive disorder) using the MAV     test. The investigators intend to use the MAV tool in future research in Parkinson's disease     and depression.   "
135400|NCT01512524|"     The primary objective is to assess the long-term impact of hormonal deficiency on Quality of     Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.   "
135386|NCT01512706|"     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family     Picornaviridae.      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by     EV71 infection. Because of these EV71 infection-related public health issues, the research     and development of EV71 vaccine candidates have been heavily promoted.      Recently, several EV71 vaccine candidates have been evaluated in animals but no final results     of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA     vaccine, epitope peptide vaccine, virus-like particles (VLPs).      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA     in China, Dec. 2010. The phase I clinical trial was completed, during four months, in Guangxi     Province, China. The phase II clinical trial has been carried out, from July 2011. The     purpose of phase II is to evaluate the safety and efficacy of the formalin-inactivated EV71     vaccine in Chinese infants (from 6 to 36 months old).   "
135387|NCT01512693|"     This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50     milligram (mg) dose of MK-0822 in participants with and without moderate hepatic     insufficiency (abnormal liver function) in order to determine to what degree hepatic     dysfunction may impact therapeutic blood levels of MK-0822.   "
135388|NCT01512680|"     Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients     which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis     is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better     quality of life. 60 patient will be enrolled and followed during one year.   "
135389|NCT01512667|"     This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib     administered to participants with impaired renal/kidney function to those of a healthy     matched control group.   "
135390|NCT01512654|"     The primary purpose of this study is to see whether a tool that predict blood glucose and     suggest therapy advices can help type 1 diabetic patients.   "
135391|NCT01512641|"     Schizophrenia beginning before 18 years is a clinical entity not well known because of its     low incidence and difficulties in the clinical diagnosis.      However, in the investigators clinical practice, due to the specialization of the     investigators service, the investigators are led to hospital to receive important feel active     of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text     revision (DSM IV-TR) precose schizophrenia.      The work of us team on the theme of the relationship between Pervasive Developmental     Disorders and precose Schizophrenia led us to hypothesize that a number of children in care     in the medical and educational institutes, hospitals and day shelters therapeutic part-time     symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not     diagnosed.      The main goal is to estimate the prevalence of dissociative disorders in a population of     children in care institutions and medical education in child psychiatry in hospitals and     others structures.   "
135392|NCT01512628|"     The investigators administered different kinds of colloids before transfusion of red blood     cell to patient undergoing total hip replacement arthroplasty. The investigators will compare     the differences of changes in rotational thromboelastometry (ROTEM) data among them.   "
135393|NCT01512615|"     The aim of the study is to describe the effect and meaning of an integrated rehabilitation     programme, consisting of physical training and psycho-educational care, for patients treated     for infective endocarditis.      The hypothesis is, that integrated rehabilitation can improve mental health, physical     capacity and other factors.   "
135394|NCT01512602|"     Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior     Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed     supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with     self behavior and personality traits within the spectrum of borderline personality disorder.      Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT)     after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on     self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and     consumption of hospital services in patients with symptoms within the spectrum of borderline     personality disorder (BDP).      Method: The investigators will include 160 patients in the randomized trial to investigate     whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive     psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm     behavior and personality traits within the spectrum of borderline personality disorder. The     trial will meet strict criteria for high quality randomized trials, and will hopefully help     to establish evidence for the treatment of this patient group at higher risk of later     suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.   "
135395|NCT01512589|"     The goal of this clinical research study is to learn how safe and effective proton-beam     therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in     combination with chemotherapy in patients with esophageal cancer.      PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area     of the body while affecting as little of the surrounding normal tissue as possible. PBT is a     newer technology that is designed to further reduce the amount of radiation that affects the     surrounding normal tissue. However, this is still being studied.   "
135396|NCT01512576|"     This physiological study examines whether acupuncture exerts short-term effects of analgesic     mechanisms in patients with chronic whiplash pain. More specifically, it is examined whether     acupuncture activates brain-orchestrated pain inhibitory action.   "
135397|NCT01512563|"     Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common     Covered Metallic Biliary Stent.   "
135398|NCT01512550|"     The purpose of this prospective, randomized study is to evaluate the importance of restoring     the exact individual hip biomechanics during total hip arthroplasty.   "
135399|NCT01512537|"     The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in     treatment of vitamin D deficiency.   "
135401|NCT01512511|"     There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common     use, has not compared to N2O sufficiently to disclose which one has minimal physiological     invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the     hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal     CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were     recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure     by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and     compared.   "
135402|NCT01512498|"     The study will evaluate the prevalence and characteristics of vulvovaginal graft versus host     disease (VV- GVHD) in patients who underwent hematopoietic stem cell transplantation (HSCT)     as girls or adolescents and will compare the prevalence, characteristics and severity of     VV-GVHD before and after menarche.   "
135403|NCT01512485|"     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's     Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75     mg tablet under fed condition.   "
135404|NCT01512472|"     Men with localized prostate cancer requiring intermittent androgen deprivation therapy for     biochemical recurrence following radical therapy will be asked to participate in a phase 4     safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix     (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.   "
135405|NCT01512459|"     The objective of this study was to compare the relative bioavailability of Venlafaxine MR     Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human     subjects.   "
135406|NCT01512446|"     The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long     term treatment of osteoporosis.   "
135407|NCT01512433|"     The purpose of this study is to investigate the efficacy of acupuncture therapy combined with     standard methadone maintenance therapy to the heroin addicts.   "
135408|NCT01512420|"     This prospective observational study will evaluate the efficacy and safety of second-line     Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer     with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study     is to identify from baseline clinical and demographic patient characteristics prognostic     factors related to overall survival with second-line Tarceva treatment. Data will be     collected from eligible patients for up to 2 years.   "
135409|NCT01512407|"     We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection     in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver     and thus improve survival. The aim of this study is to compare the survival of patients     undergoing liver resection plus post-operative TACE versus liver resection alone.   "
135410|NCT01512394|"     Current management of elective bowel surgery typically involves performing a preoperative     bowel preparation (bowel prep) in many instances; however, this practice is not     standardized at most institutions. Over the years, bowel preps have been used in an attempt     to decrease the risk of complications associated with gastrointestinal surgery. However,     there is limited adequate data to support this clinical management in the pediatric patient     population. The investigator plans to perform a prospective, randomized study of our     pediatric surgical patients who will undergo an elective bowel resection or ostomy closure to     assess if a bowel prep prior to surgical intervention affects their postoperative course. The     aim of this study is to evaluate for differences that may alter and improve future     management.   "
135411|NCT01512381|"     The purpose of this study is to determine whether cardiac resynchronization therapy (CRT) is     superior to interventricular right ventricle (RV) septal pacing in respect of reverse     remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection     fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received     atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)   "
135412|NCT01512368|"     We evaluated the effect of two weeks of intensive supervised physical activity in serum     fibroblast growth factor 21 (FGF21) levels.   "
135413|NCT01512355|"     Postoperative agitation in children is a well-documented clinical phenomenon with incidence     ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the     pediatric population and there is now increasing evidence to support the use of this drug as     sedative and anesthetic adjunct in children. The purpose of this study is to determine     whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium.   "
135414|NCT01512342|"     Given the lack of evidence in support of pacing self-management for patients with chronic     fatigue syndrome (CFS), it is examined whether physical behavior and health status of     patients with CFS improve in response to a pacing self-management program. The effects of     pacing will be compared with those observed when applying relaxation therapy to patients with     CFS.   "
135415|NCT01512329|"     Given the lack of evidence in support of pacing self-management for patients with musltiple     sclerosis (MS), it is examined whether physical behavior and health status of patients with     MS improve in response to a pacing self-management program. The effects of pacing will be     compared with those observed when applying relaxation therapy to patients with MS.   "
135416|NCT01512316|"     The present study investigates the effect of d-cycloserine on learning and unlearning of fear     in healthy humans and its underlying effect on the amygdala.      As a second objective, the effect of genotype on fear learning will be studied.   "
135417|NCT01512303|"     The overarching aim of this proposal is to research whether meditation-based treatments are     effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which     complementary and alternative (CA) treatments are most effective, and how individual     differences predict treatment efficacy.   "
135433|NCT01512095|"     This trial is conducted in Europe and United States of America (USA). The aim of this trial     is to examine the bioequivalence (assessment of the expected biological equivalence of two     pharmaceutical drug products with identical active ingredient) of Norditropin® versus     Nutropin AQ® in healthy adult volunteers.   "
135434|NCT01512082|"     Delayed onset muscle soreness is defined as the sensition of pain and discomfort in skeletal     muscles that occurs after eccentric muscle actions or strenuous exercise like a marathon.   "
135418|NCT01512290|"     Auditory verbal hallucinations (AVH) are a characterising symptom of schizophrenia. In the     majority of patients, these AVH respond well to antipsychotic medication. Yet, a significant     minority continues to experience frequent AVH despite optimal pharmacotherapy. The number of     alternative treatment options for this medication resistant group is currently low and most     of them focus on coping with the hallucinations. Transcranial magnetic stimulation (TMS), in     contrast, is a non-invasive technique of influencing cortical excitability. This technique     has the potential to actually decrease the frequency and severity of medication resistant     hallucinations.      Several previous studies have assessed efficacy of low frequency rTMS, with contradicting     results. A previous large study by the investigators group could not demonstrate efficacy of     low frequency rTMS. A new stimulation protocol using theta burst rTMS (TBS) could provide a     more effective therapeutic option.      Objective: The present study aims to examine the efficacy of TBS on the severity of AVH.     Study design: The objectives are tested in a randomized double blind placebo-controlled     trail.      Study population: 60 patients with the diagnosis of schizophrenia, schizoaffective disorder,     schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal     hallucinations will be included.      Intervention: The participant will receive either 10 TBS treatments or 10 placebo treatments     consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area,     distributed over 5 treatment days. Stimulation will be at 80% of the motor threshold.      Main study parameters/endpoints: the main study parameter is the change in the severity of     the AVH. The secondary study parameter is the number and severity of adverse events.   "
135419|NCT01512277|"     The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy     volunteers of the vaccine candidate against schistosomiasis named Bilhvax.   "
135420|NCT01512264|"     In this study the investigators will examine the efficacy of (1) navigated excitatory     repetitive transcranial magnetic stimulation (nerTMS) and (2) a combination of nerTMS and     constraint induced aphasia therapy (CIAT) as post-stroke aphasia rehabilitation methods. The     investigators expect that these new types of rehabilitation, either nerTMS alone or in     combination with CIAT, will help patients with aphasia return to their lives as they were     prior to the stroke.   "
135421|NCT01512251|"     This is a phase 1/2 clinical trial with the goal of determining whether the addition of the     investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free     survival in patients with BRAFV600E/K mutant melanoma.   "
135422|NCT01512238|"     The purpose is to study if different factors influence medicine adherence in elderly people.     In this study number of generic substitution and use of non-prescription drugs, herbal     medicine and dietary supplement is in focus.   "
135423|NCT01512225|"     The purpose of this study is to evaluate the safety and efficacy of Domperidone in those     mothers who are identified as having difficulty with breast milk production to meet the     nutritional needs of their infant in the neonatal intensive are unit hospitalization setting,     and to determine how it should be considered in the care of mothers and their preterm infants     without causing undesirable effects to either the mother or infant.   "
135424|NCT01512212|"     Evaluation of the effectivity of the new thyroid fine needle aspiration biopsy (FNAB)     apparatus of which patented from Turkish Patent Institute.   "
135425|NCT01512199|"     This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are     receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b     portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in     subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the     treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel with     U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine if     adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in subjects     with metastatic breast cancer.   "
135426|NCT01512186|"     The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to surgery     (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five patients     will be recruited into his study.   "
135427|NCT01512173|"     There is an unsatisfied medical need for a first-line treatment of localized uncomplicated     proliferating Infantile Hemangioma with a good benefit/risk profile.      Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which     is a topical gel adapted to paediatric use.      The objective of this study is to evaluate topical propranolol efficacy and safety in the     management of localized hemangioma.   "
135428|NCT01512160|"     The purpose of this study is to evaluate the overall pain relief of a single dose of     PF-04531083 against placebo following third molar extraction.   "
135429|NCT01512147|"     The investigators want to know if using the study drug dexmedetomidine will improve nerve     wave readings during neurosurgery. These readings are done many times during surgery while     the patient is asleep. The readings look at how nerves are working and let the operating team     know if nerves are hurt during surgery. If the readings tell that nerves are not working     correctly, the surgeons can help while changing the way of operating.      The study drug will be used in addition to the general anesthesia that a patient is given.     The nerve readings that the investigators get while using the study drug will be compared     with nerve readings that the investigators get while not using the study drug.      The study hypothesis is that dexmedetomidine does not change nerve readings.   "
135430|NCT01512134|"     The purpose of this clinical study is to investigate the safety and efficacy of deep brain     stimulation (DBS) as a treatment option for obesity.   "
135431|NCT01512121|"     The overall objective of this study is to assess patterns of fMRI cortical activation with     spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define     cortical correlates, as well as to investigate cortical representations of pain and pain     relief and the interactions therein, in the setting of neuropathic leg pain and SCS.   "
135432|NCT01512108|"     This trial was conducted in Japan. The aim of this trial was to evaluate the safety and     efficacy of once daily administration of liraglutide in combination with an oral     anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently     controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either     glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at     unchanged type and dose.   "
135435|NCT01512069|"     Life style interventions that promote exercise and a healthy diet, which have the potential     to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer     survivors. The previous studies suggested that a key strategy to implement sustainable     healthy behavior and improve health was providing appropriate feedback and promoting     self-efficacy. Web-based program enables to provide the feedback in a timely manner on a     daily basis, to continue the healthy behaviors.      Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning     program, and whether the program can promote significantly greater changes in behavioral     outcomes [goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and     diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)], stage of changes     for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and     self-efficacy in implementing goal of exercise and diet among breast cancer survivors in     Korea was examined.      Hypotheses were following:        1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet          Planning program (hereinafter called the 'intervention group') will show a more advanced          stage of change for exercise and diet compared to survivors in the control group.        2. The intervention group will show a higher proportion of attaining goal of exercise (or          higher level of energy expenditure of aerobic exercise) compared to the control group.        3. The intervention group will show a higher proportion of attaining goal of diet (or          higher level of diet quality) compared to the control group.        4. The intervention group will show a better HRQOL level compared to the control group.        5. The intervention group will show a better self-efficacy level compared to the control          group.        6. The intervention group will show a lower fatigue level compared to the control group.        7. The intervention group will show less anxiety compared to the control group.        8. The intervention group will show less depression compared to the control group.   "
135436|NCT01512056|"     The purpose of this study is to evaluate the antibody response in dialysis patents to each of     the three influenza vaccine strains included in the licensed seasonal flu vaccine     (Formulation 2011-2012).   "
135437|NCT01512043|"     There is a demand for explorative and comparative studies on various non-pharmaceutical     efforts in treating and helping chronic obstructive pulmonary disease patients. This study     has been developed in light of this need. The main purpose of the project is to test whether     a device guided breathing control system can decreasing the feeling of breathlessness in     patients with moderate stage and severe stage of COPD. In addition the study could shed light     on whether a reduced feeling of breathlessness can lead to improved physical function, and     less experience of other symptoms (I.e., depression, anxiety, sleeping difficulties, fatigue,     pain) and provide a better quality of life for patients with COPD.   "
135438|NCT01512030|"     Diabetes mellitus type I is an increasing burden for more and younger children. Therapy     should avoid long-term complications as macrovascular diseases and diabetic nephropathy,     retinopathy and diabetic neuropathy (DN). There is considerable uncertainty about the     prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic     criteria. Nerve conduction velocity studies are regarded as the gold standard for     investigating neuropathies.      We plan a prospective study by investigating the peripheral nerve conduction velocity in a     population of diabetic children. At the same time-points, we will do a neurological     examination using the Young Score, a clinical score of peripheral neuropathy [10]. The     results obtained will be related to other long-term vascular complications (nephropathy,     retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of     sports/week, and BMI   "
135439|NCT01512017|"     This study is a multi-center, randomized, open and paralleled positive control study for     evaluating the safety and efficacy of Veloderm in treatment of split-thickness skin graft     donor sites. The result implies that Veloerm can do it better than Vaseline gauze in     accelerating and promoting wound healing of skin graft donor sites. The present study have     indicated that high permeability of Veloderm dressing to oxygen and water vapor.   "
135440|NCT01512004|"     The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine     Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese     population with urgent micturition, frequent micturition and/or urge urinary incontinence.   "
135441|NCT01511991|"     The purpose of this study is to determine sevoflurane's dose-dependent effect on left     ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of     lateral mitral valve annular velocity at three different sevoflurane concentrations would be     analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery     patients.   "
135442|NCT01511978|"     Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome     (LEMS)-related weakness.   "
135443|NCT01511965|"     Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of     melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and     social, that sounds a lot about the quality of life. Currently the standard treatment for     vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half     of patients. The applications of autologous epidermal cells in the liquid phase is a     promising new therapeutic approach of vitiligo.      The main goal of this study is to compare prospectively the repigmentation of vitiligo     lesions induced by application of autologous epidermal cells in liquid phase associated with     light therapy and light therapy alone.      Study's secondary goals: compare the applications of epidermal cells to phototherapy alone     and phototherapy, in respect of:        -  Obtain a repigmentation> 70% (threshold considered aesthetically relevant)        -  The occurrence of adverse events        -  Patient satisfaction regarding the efficacy and safety of treatment   "
135444|NCT01511952|"     This is a multi-site study of 272 premature infants >32 weeks who served in a randomized     investigation (in morning or afternoon) where they served as their own controls. The infants'     HR, RR, O2sats were measured with and without the implementation fo live music. The live     interventions included songs of kin, selected by parents, the gato box and ocean disc played     through entrained methods by a music therapist. The infants were evaluated within a two week     period and in total each day including feeds, voids, activity level and sleep.   "
135445|NCT01511939|"     The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug     (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who     are also taking anticoagulant or antithrombotic medications.   "
135446|NCT01511926|"     The most common pain-relievers used by patients with rheumatic disorders are called     non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are effective and well     documented, but they can cause ulcers and gastrointestinal side effects. Vimovo™ is a tablet     containing naproxen (NSAID) and a gastroprotective agent called esomeprazole. Patients with     rheumatic disorders, who are at risk for developing gastrointestinal side effects, and where     lower doses of naproxen or other NSAID treatment is not considered sufficient, could use this     tablet. The regulatory authorities in many European countries have approved the use of     Vimovo™, but they would like to understand how various factors influence the doctors'     decision to prescribe the tablet and what is characterizing the patients receiving it. The     aim of the study is to answer these questions.   "
135451|NCT01511861|"     Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic     goal that is difficult to achieve with current blood glucose monitoring technology. Home     blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of     severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy     to operate glucose monitoring in DM patients for strict glycemic control cannot be     overemphasized.      The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an     acceptable mean relative error when compared to acceptable invasive blood glucose     measurements.      The primary objectives of the trial are to determine:        1. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels          compare to the standard glucose blood test        2. Creating database of glucose levels readings utilizing the Glucometer GM-205.   "
135452|NCT01511848|"     Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of     combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional     iron overload      Primary Outcome Measures:      • The primary outcome measure is to assess efficacy in lowering serum ferritin level(the     change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to     combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of     SF over previous 12 months on single chelator.      Secondary Outcome Measures:      • The secondary outcome measure is to determine the number of patients who will develop     adverse events in order to assess safety upon administering the drugs in combination (DFP and     DFX) compared to the combination of DFO and DFP.   "
135453|NCT01511835|"     The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational     diabetes in high risk pregnant women.   "
135454|NCT01511822|"     Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and     endocrine abnormalities and clinical symptoms.      The primary defect in PCOS consists of an abnormal androgen synthesis and secretion,     particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers,     explaining the frequent association of PCOS with these metabolic conditions.     Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal     androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It     results in an increase in free, biologically active androgens which are related to clinical     signs such as hirsutism, acne, seborrhea, and alopecia.      Combined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely     used in this group of patients providing clinical improvement in the areas of excessive hair     growth, unpredictable menses, acne, and weight gain.      More recent studies outlined a deficiency in myo-inositol in women with PCOS and     insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it     plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle     trafficking, and chromatin remodeling. It is a precursor in the synthesis of     phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.      It has been reported that the administration of myo-inositol reduces serum insulin, decreases     serum testosterone and enhances ovulation.      Due to the different beneficial actions, the aim of the present study is to evaluate the     clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl     estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin     resistance.   "
135455|NCT01511809|"     The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior     proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable     suppressed viremia and no prior virologic failures.   "
135456|NCT01511796|"     The purpose of this study is to examine the effects of a combination of Botulinum Toxin (BT)     and Upper Limb (UL) rehabilitation compared to BT only on UL motor function in adults with     spasticity after stroke using a pre-post design. The research question is whether combination     of BT and UL rehabilitation compared to BT only is more effective in improving the UL     function, range of motion and pain.   "
135457|NCT01511783|"     The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to     evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when     administered to healthy elderly subjects.   "
135458|NCT01511770|"     The objective of this study was an open-label, randomized, 2-way crossover to compare the     single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®)     200 mg fluconazole tablets under fasting conditions.   "
135459|NCT01511757|"     The objective of this study was an open-label, randomized, 2-way crossover to compare the     single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®)     200 mg fluconazole tablets under fed conditions.   "
135460|NCT01511744|"     Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological     Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the     influenza immunity of age 3 and older population. Phase III clinical study was conducted in     Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had good     safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production     approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008.      In order to monitor and evaluate the safety and protective effect against influenza     administered on age 3 and older population, therefore we conduct the phase IV clinical trial     of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).   "
135461|NCT01511731|"     The objective of this study was to compare the single-dose relative bioavailability of Reddy     Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.   "
135462|NCT01511718|"     This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single     dose, crossover, oral bioequivalence study.   "
135466|NCT01511666|"     Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter     clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest     compression device, extracorporeal life support (ECLS) and early invasive investigation and     treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary     angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed     cardiac origin compared to standard of care. It is hypothesized, that above stated     hyperinvasive approach might improve outcome of out-of hospital cardiac arrest victims.   "
135467|NCT01511653|"     The investigators are undertaking a multi-center, 6000 subject validation study of several     biomarkers for early detection of colon cancer. There are 2 stool based biomarkers (one is a     panel) and 1 serum based biomarker being validated in this study. The biomarkers will be     compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the     current standards for colon cancer screening. This is an NCI-early Detection Research Network     funded project. The population targeted for this study are those persons undergoing     colonoscopy for screening or routine surveillance. Prior to colonoscopy or even prepping for     colonoscopy, subjects will provide blood and stool samples as well as specific data regarding     their GI and general medical history and concomitant medications. If subjects are interested     in participating, arrangements will be made to see them. The informed consent process will     take place, blood will be obtained, data will be obtained, and the stool kit described and     given to the subject to take home. Stool samples will be sent back to the University of     Michigan from all sites using prepaid UPS mailing labels.   "
135468|NCT01511640|"     Cannabis is the most commonly used illicit drug in the United States, and its use is     associated with rates of development of abuse and dependence, treatment admission and relapse     that are comparable to other illicit drugs. Currently there is no effective pharmacological     treatment for cannabis-use disorders. The purpose of the present study is to evaluate the     ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a     medication for cannabis-use disorders.   "
135469|NCT01511627|"     The investigators hypothesize that a spinal anesthetic administered prior to the induction of     general anesthesia will result in reduced need for pain medication and reduced postoperative     pain, as well as reduced hospital stay following a total abdominal hysterectomy.   "
135470|NCT01511614|"     Background:      - Smoking is thought to cause changes in the brain that lead to addiction and craving.     Smokers who try to quit experience nicotine withdrawal symptoms that include irritability,     anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop     smoking. Many people say that they continue smoking to help relieve these symptoms, often     within the first week after trying to quit. Researchers want to study what is happening in     the brain to cause these symptoms, which may help identify new ways to successfully quit     smoking.      Objectives:      - To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36     hours.      Eligibility:      - Individuals between 18 and 55 years of age who smoke at least 10 cigarettes per day.     Participants must be able to stop smoking for 36 hours on two occasions.      Design:        -  This study will involve three visits to the National Institute on Drug Abuse.        -  Participants will be screened with a medical history and physical exam. Blood and urine          samples will be collected, as well as breath samples to test for recent alcohol use.          Participants will also fill out questionnaires and learn about the tests at the next two          visits.        -  Before each imaging visit, participants will stop smoking for 36 hours. Before one          visit, participants will wear a nicotine skin patch. Before the other visit,          participants will wear a placebo (dummy) patch with no nicotine. Participants will not          be told which type of patch they are wearing. Participants will measure the level of          carbon monoxide in their breath during both of these nonsmoking periods. They will also          complete questionnaires about mood and cigarette cravings.        -  Participants will have two study visits with imaging studies to measure brain activity.          Each imaging visit will last about 9 to 10 hours. The visit will involve two separate          1.5- to 2-hour scan sessions (a morning scan and an afternoon scan). These scan sessions          will involve tests of concentration, memory, and reaction time. Other tests and          questionnaires will also be completed outside of the scanner before and after the          sessions.   "
135471|NCT01511601|"     Background:      - Some clinical trials require larger amounts of plasma and white blood cells than can be     collected through simple blood donations. Apheresis is a procedure used to collect parts of     the blood for study and return the rest of the blood to the donor. Healthy volunteers who     provide plasma and white blood cells for study may need to give multiple donations.     Researchers want to use apheresis to collect plasma and white blood cells from healthy     volunteers in Mali.      Objectives:      - To collect plasma and white blood cells from healthy volunteers in Mali.      Eligibility:        -  Healthy volunteers between 18 and 55 years of age.        -  Volunteers must be in National Institute of Allergy and Infectious Diseases clinical          trials.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          provide basic blood and urine samples.        -  Participants will have apheresis to collect plasma and white blood cells for study.          Before each collection, they will provide a small blood sample for testing. They will be          monitored during and after donation to prevent side effects.        -  Under this protocol, participants may have apheresis up to six times per year.        -  No treatment will be provided as part of this protocol.   "
135472|NCT01511588|"     Background:      - The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels     through the bloodstream to the pituitary gland, where it stimulates the gland to produce     hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The     testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare     for ovulation. Normal estrogen and testosterone levels are required for puberty. Some people,     however, have either low levels or total lack of GnRH. This can cause problems with puberty     and fertility. Researchers want to study people with low or no GnRH to better understand how     it affects puberty and fertility.      Objectives:      - To study disorders of GnRH production.      Eligibility:        -  Adult men and women at least 18 years of age with low or no gonadotropin levels.        -  Adolescents between 14 and 18 years of age with low or no gonadotropin levels.      Design:        -  Participants will be screened with a physical exam and medical history. Blood and urine          samples will be collected.        -  Participants will have tests to look at their hormone levels. Blood samples may be          collected after taking different drugs, including insulin and cortisone. A 24-hour urine          sample will be collected.        -  Participants will have imaging studies to look at bone and brain development. They will          also have ultrasounds of the kidneys, abdomen, and reproductive organs.        -  Tests of smell and hearing will be used to look for abnormalities in these senses.   "
135473|NCT01511575|"     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in     the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers     related to cancer.      PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute     myeloid leukemia or other transient myeloproliferative disorder.   "
135474|NCT01511562|"     The purpose of this study is to find out what effects (good and/or bad) treatment with     chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary     CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell     lymphoma is not known.   "
135475|NCT01511549|"     Primary Objective:      To assess the safety and tolerability of SAR113945 in Japanese patients with knee     osteoarthritis after ascending single intra-articular doses      Secondary Objective:      To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis     after ascending single intra-articular doses   "
135476|NCT01511536|"     Primary Objectives:        -  To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel          administered as a 1-hour infusion every 3 weeks in combination with oral daily          abiraterone acetate and prednisone in participants with metastatic Castrate-resistant          prostate cancer (CRPC)        -  To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone          acetate and prednisone in terms of prostate-specific antigen (PSA) response rate.      Secondary Objectives:        -  To characterize the safety profile of the combination        -  To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed          combination and dosing schedule        -  To assess preliminary antitumor activity of the combination in terms of progression-free          survival, PSA progression free survival and objective response rate, and overall          survival   "
135477|NCT01511523|"     A research study of a compound containing vitamin E, silymarin and carnitine, three over the     counter supplements. The investigators hope to learn if the new supplement can safely and     successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).   "
135478|NCT01511510|"     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a     number of ascending doses administered once daily for 14 days in healthy volunteers.   "
135479|NCT01511497|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and     pharmacodynamics of PF-04427429 in healthy women.   "
135480|NCT01511484|"     This study investigated whether illustration of the facial appearance benefits of fruit and     vegetable consumption is able to motivate increased intake of this food group. The     investigators hypothesize that individuals witnessing illustrations of the impact of a     healthy diet will exhibit improvements in diet relative to a control group receiving only     information on the health-benefits of this food group.   "
135481|NCT01511471|"     Clopidogrel administration is commonly prescribed in patients undergoing percutaneous     coronary intervention, in patients with previous stroke and in patients under chronic     hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel     response compared to those with normal renal function. Ticagrelor is a new oral direct-acting     antagonist, which provides greater platelet inhibition in both clopidogrel responders and     non-responders. It has also been shown that in patients with chronic kidney disease     (creatinine clearance <60 mL/min)ticagrelor achieved an absolute risk reduction of     cardiovascular death, myocardial infarction, and stroke greater than that of patients with     normal renal function. Clopidogrel resistant patients as assessed by VerifyNow     P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily     for 15 days. Platelet reactivity will be determined at the end of the treatment period.     Bleeding events, major adverse cardiac events and any side effects until Day 15 will be     reported in a descriptive manner.   "
135482|NCT01511458|"     The purpose of this blinded, multi-center, prospective, case-controlled study is to compare     the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester     prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG [β-hCG] or total     hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in     a general screened population.      The performance characteristics of these two test modalities will be assessed relative to the     clinical reference standard of genetic analysis of the fetus or phenotypic characterization     and genetic analysis of the newborn.   "
135483|NCT01511445|"     This study randomizes neck and arm pain patients being treated with discectomy and anterior     interbody fusion into two groups: one to receive a new ceramic implant and a control group     with a more traditional plastic implant. The study will measure and compare pain and     disability improvement with the two products over a period of two years. The fusion status     will also be judged with plane x-rays and one CT scan.   "
135484|NCT01511432|"     The purpose of this study is to evaluate the relative bioavailability, safety, and     tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.   "
135485|NCT01511419|"     The study hypothesis is that two doses of cold-adapted, live monovalent     A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in     healthy adults.   "
135486|NCT01511406|"     The purpose of the present study is to examine whether cognitive behavior therapy will reduce     depressive symptoms and increase self-esteem for patients with a first episode psychosis.   "
135487|NCT01511393|"     This study is conducted in the United States of America (USA). The aim of the study is to     monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish     a registry for these new cases in order to identify any possible increase related to the     introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into     the US market.   "
135488|NCT01511380|"     This study is designed to gain knowledge about effective interventions for reducing HIV risk     in a high risk population. A new Risk Reduction Therapy for Adolescents (RRTA) will be     compared to usual services received by youth in juvenile drug courts. It is expected that     youth treated with RRTA will show greater reductions in substance use and risky sexual     behaviors. Reducing HIV risk by effectively targeting substance use and risky sexual     behaviors in high-risk groups such as juvenile drug court-involved youth could favorably     impact society at multiple levels (individual, family, peer, community, fiscal).   "
135489|NCT01511367|"     This is a comparator study to assess safety and efficacy of Flutiform compared with     Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe     persistent, reversible asthma.   "
135504|NCT01511172|"     This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect     on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin     given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic     agents).   "
135506|NCT01511146|"     The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good     options in patients with liver metastases. If the patients have colorectal cancer and never     had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If     the patient is K-RAS wild type the investigators will add cetuximab. In patients who had     received oxaliplatin or in patients with other cancers the investigators will use mitomycin     and gemcitabine together with capecitabine.   "
135490|NCT01511354|"     The need for certain components of food (i.e. protein) for critically ill children is not     clear. It is important to have critically ill children fed adequately to prevent that their     condition becomes worse or that recovery takes longer. Research methods used in the past to     investigate the need for protein (Nitrogen Balance calculations), were not sensitive enough     in severely ill children. The purpose of this study is to develop a new research method to     determine the need for protein in severely ill children. In order to develop this new method,     more information is needed on the way the body of these children uses protein in 24-hours. In     the present study during 24-hours 8 children of age less than 18 years who are admitted to     either the Pediatric ICU or the Cardiovascular ICU. Subjects will receive a standard     nutrition, providing an age specific amount of protein (age ≤ 3: 2.52 protein g/kg BW.d; age     4-6: 1.8 protein g/kg BW.d; age > 10: 1.44 protein g/kg BW.d) via tube feeding. They will     also receive a mixture of stable isotopes of amino to investigate protein behavior in the     body (protein kinetics) both by infusion in their blood and together with the nutrition.     Blood will be drawn every 60 minutes during the 24-hour period and the behavior of protein     and the concentrations in blood of amino acids and urea will be measured. Urine will be     collected to measure nitrogen balance. The investigators will compare the results of this     nitrogen balance method with the results of the stable isotope method. PIM2, PRISM, SIRS     criteria will be used to get information on the severity of illness of the subjects. Also     body weight and length as well as body composition of the subjects will be measured at the     start and after the 24-hour period. Body composition will be measured by Bioelectrical     Impedance Spectroscopy. Endpoints of the study are net whole-body protein synthesis (protein     balance), 24-hour pattern of protein balance, 24-hour urea production, 24-hour nitrogen     balance, 24-hour contribution of arginine kinetics to whole body protein breakdown, 24-hour     muscle protein breakdown, splanchnic amino acid extraction and plasma amino acid     concentrations.   "
135491|NCT01511341|"     Paediatric rheumatisms represent a large group of inflammatory and non-inflammatory diseases     of the locomotion system. The annual rate incidence of children diagnosed with rheumatic     disease in Switzerland (canton of Vaud) is 56.8 for 100'000 children. These children     experience a chronic course of the disease impacting on their quality of life and family     functioning. Their medical treatment is significant and may last for life. Caring for these     children involves a multidisciplinary approach. Control of the disease and management of the     symptoms becomes of foremost importance to minimise disability and pain. In addition to     medical care, the supporting role of nurses in the care of children with rheumatic diseases     and their family aims to limit the potential for further deformity, disability, and     psychological complications. In particular, they play a key role in supporting the specialist     team caring for patients with rheumatism disease, recognising poor disease control and the     need for changes in treatment, providing a resource to patients on treatment options and how     to access additional support and advice, and identifying best practice to achieve optimal     outcomes for the patients and their family. Nurses also ensure the link between medical     practitioner, other health providers, and family, thus play a key role in the follow-up care     of the child and its family. Follow-up of children and their family can be ensured by regular     telephone consultation (telenursing) made by experienced nurse specialists in rheumatology.     However, the effectiveness of telenursing remains to be proven in children with chronic     rheumatic diseases. The aim of this study is, therefore, to evaluate the effect of a     telephone nursing intervention on the outcomes of family and children with rheumatism chronic     disease.      This randomised crossover, experimental longitudinal study will be carried out in the     outpatient clinic of paediatric rheumatology of a tertiary referral hospital in canton of     Vaud. The population will consist of children newly diagnosed with inflammatory rheumatologic     diseases and one of their parent. The nurse-led intervention will consist of providing a     monthly telephone call by a qualified and experienced nurse specialist in paediatric     rheumatology and TN to ensure follow-up of the children and their family. The intervention     will focus on providing affective support, health information, and aid to making decision.   "
135492|NCT01511328|"     The purpose is to evaluate whether implementation of primary human papillomavirus (HPV)     screening in the screening programme for cervical cancer improves the programme in terms of     better cancer protection and better cost efficiency.   "
135493|NCT01511315|"     This study aims to see if patient quality of life can be approved after treatment with an     injectable medication called ustekinumab for the treatment of generalized psoriasis. The     investigators hypothesize that the investigators will see improvement in quality of life.   "
135494|NCT01511302|"     The purpose of this study is to determine whether RNS60, in combination with budesonide, is     safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared     to a 28-day control period.   "
135495|NCT01511289|"     In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg     twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients     with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase     (CML-CP).   "
135496|NCT01511276|"     Physical inactivity and overweight are two accepted risk factors for breast cancer. However,     because of their correlation it is not clear which is most relevant to risk. The     investigators now set out to study whether physical activity in addition to weight loss by     diet only, affects sex hormone levels, known to be related to breast cancer risk.      In the SHAPE-2 study 250 healthy overweight/obese and physically inactive women are randomly     allocated to a diet-induced weight loss group, a combined exercise- and diet-induced weight     loss group or a control group. The aim of the first two intervention groups is to loose 5-6     kg of bodyweight, either by dieting or mainly by increased physical activity. Measurements     are performed at baseline and after 21 weeks, the end of the study period.      The aim of this study is to provide insight into the effect of weight loss mainly driven by     exercise compared to equivalent weight loss due to nutritional calorie restriction on breast     cancer biomarkers.   "
135497|NCT01511263|"     In a proportion of patients with AL amyloidosis there is no improvement of cardiac function     despite hematologic response to treatment. The aim of the study is to assess whether     treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis     who completed chemotherapy.   "
135498|NCT01511250|"     The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine     (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In     addition the antibody response to the four dengue virus serotypes will be evaluated.   "
135499|NCT01511237|"     The purpose is to evaluate the efficacy of maternal and infant perinatal antiretroviral     prophylaxis intensification for the prevention of mother-to-child intrapartum transmission of     HIV-1 in women receiving less than 8 weeks of antiretroviral prophylaxis during pregnancy.   "
135500|NCT01511224|"     Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in     hospitals locally and worldwide. There is lack of prospective comparative clinical data to     guide optimal strategy for treating such infections. Since it remains unclear how to treat     bacteremia caused by AB, the present study aims to enroll patients at multiple sites with     extensively drug resistant Acinetobacter species bacteremia receiving different combination     therapy to assess treatment outcomes and analyze risk factors associated with mortality.   "
135501|NCT01511211|"     This is a Randomized Double blinded controlled trial on the effect of adding dexamethasone to     Ropivacaine on the duration of pain relief for ultrasound guided femoral, obturator and     popliteal block after total knee replacement surgery.   "
135502|NCT01511198|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     determine the dose-response relationship for body weight and five escalating doses of NNC     90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral     hypoglycemic agent (OHA).   "
135503|NCT01511185|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose     concentrations in subjects with type 2 diabetes.   "
135508|NCT01511120|"     The impact on fluid loading after cardiac surgery by use of two different priming solution      Fluid overloading with oedema formation is a regular finding following on-pump cardiac     surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been     reported to impair both systolic and diastolic function. An association between     intraoperative fluid loading and postoperative adverse outcome has been demonstrated in     cardiac patients.      The investigators have experience with the use of both colloides and combination fluids     (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the     investigators used colloides as an additive to the CPB-prime. The investigators observed     reduced fluid leakage and less total tissue water in several organs.      The planned study includes patients scheduled for coronary artery bypass, and who have no     co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated     Ringer`s solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and     diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume     (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be     monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.   "
135509|NCT01511107|"     The investigators will study whether, in young children with acute otitis media (AOM),     shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance     provides satisfactory clinical outcome. This is a Phase 2b multicenter, randomized,     double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months     comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with     that of consistent standard-duration treatment (10 days) for each episode of AOM developing     during a single respiratory season (October 1 through May 31).   "
135510|NCT01511094|"     The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a     first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with     good vision.   "
135511|NCT01511081|"     The goal of this clinical research study is to compare 2 types of radiotherapy, stereotactic     body photon radiotherapy (SBRT) and stereotactic body proton radiotherapy (SBPT). Researchers     would like to compare the side effects, quality of life, and cancer control.   "
135512|NCT01511068|"     The purpose of this study is to evaluate the therapeutic efficacy of inhaled recombinant     human GM-CSF in individuals with hereditary Pulmonary Alveolar Proteinosis (PAP) due to     partial dysfunction of the GM-CSF receptor.   "
135513|NCT01511055|"     Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete     surgical resection, also known as a R0 resection. At present, the ability to perform a     complete resection with negative margins is limited by the surgeon's ability to palpate and     visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and     costs while maintaining or improving surgical and oncologic outcomes, the investigators must     develop technologies that improve visualization of the primary tumor and occult metastases,     real time, during surgery. Recent research has demonstrated that the use of fluorescent     probes that recognize cancer specific antigens can be used for this purpose when visualized     using a prototype near-infrared multispectral imaging system.      This investigation will determine if folate-FITC, a fluorescent probe that recognizes the     folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and     detect tumor nodules not visible to the naked eye.   "
135514|NCT01511042|"     The investigators are very excited that the National Institutes of Health are sponsoring us     to investigate why patients with diabetes are more likely to develop high blood pressure,     atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our     research program. The first part is a screening visit. At this visit you will be given a     brief physical exam and will be asked questions concerning your medical history. During the     same visit you will have your blood drawn for routine screening and to prepare DNA for     genetic testing. You will also be asked to collect a urine sample for routine screening.      If the doctor finds that you are a healthy candidate you will be invited to participate in     the second part of the study. During Phase II the investigators will perform physiologic     tests after you are placed on a low salt diet and again after you are placed on a high salt     diet. All of the food that you will eat during the two diets will be provided to you by the     hospital. If you are on blood pressure medication, it may be necessary to discontinue taking     your present medication for up to three months before beginning the study. Patients     discontinuing their current blood pressure medication may be placed on a different blood     pressure medication during this washout period if necessary to maintain blood pressure at     pre-study levels. The investigators will take you off all medications, except cholesterol     medications two weeks prior to your scheduled in-patient study. However, if you are currently     on medication to control your diabetes you will remain on this throughout the entire study.      Once your blood pressure medications are discontinued, you will be closely monitored to make     sure you do not encounter any difficulty. If you do not own a home blood pressure monitor,     the investigators will provide one for to use during the study so that you can keep a daily     record of your blood pressure readings. The investigators will ask you to call us every three     days to report your blood pressure readings. Less than 20% of patients with hypertension have     any significant increase in their blood pressure during this short time off therapy. After     you have been off your medication for nine days the dieticians will give you low salt meals     to eat at home for six days. On the sixth day of the low salt diet, you will be asked to     begin a 24-hour urine collection. You will also be required to come to the Ambulatory     Clinical Center (221 Longwood Ave.) for a one-hour test. You will return that evening to the     inpatient Clinical Research Center where you will be admitted for your first study that will     occur the next morning. On the morning of your low salt study you will have three naturally     occurring hormones administered and blood samples drawn from an intravenous needle. The     investigators will also take ultrasound pictures of your heart to see how salt and hormones     affect the way the heart functions. These tests will last approximately five hours and you     will be discharged around 12:00 p.m. The dieticians will then give you your meals for the     next week to take home. Each of these meals will have a high salt content. After six days of     your high salt diet, on the morning of your second admission to the hospital, you will be     asked to begin a final 24-hour urine collection. The same study that was done for the low     salt study will be repeated for the high salt study. You will be discharged around 3:00 p.m.     This study will determine if you are salt-sensitive. A high salt diet has been found to lead     to higher blood pressure and weight gain. In addition, the investigators hope to learn more     about the hormones that regulate your blood pressure and the genes responsible for regulating     those hormones.      You will be placed back on your initial blood pressure medication (if you are on any) and     returned to your regular physician for care. The investigators will provide clinically     relevant information to you and your physician.   "
135515|NCT01511029|"     To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to     healthy volunteers.   "
135516|NCT01511016|"     HIV lipodystrophy syndrome (HLS) is characterized by loss of fat in the arms and legs, with     increase in fat in the abdomen, and abnormal blood lipid levels. Persons with HLS have high     risk for cardiovascular disease and diabetes mellitus and the metabolic syndrome. The     investigators have previously shown that the abnormal lipid levels and lipodystrophy in HLS     are associated with defective regulation of lipid metabolic rates, specifically, accelerated     lipolysis (breakdown of stored fats), and decreased fat oxidation (utilization of fats for     energy). Patients with HLS also have low levels of the hormone leptin. The investigators     hypothesize that treatment of these patients with leptin will improve fat oxidation and may     slow the rate of lipolysis. Hence, the investigators propose to study the effect of leptin     therapy on lipid metabolic rates and lipid and glucose levels in adults with HLS. The     investigators will use state of the art stable isotope tracer techniques and gas     chromatography mass spectrometry (GCMS) to measure lipolysis, fat oxidation, and fat     re-esterification in adipose tissues and liver.   "
135517|NCT01511003|"     This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis     patients who showed unsuccessful response to existing DMARDs.   "
135518|NCT01510990|"     When considering 1st line gefitinib treatment for NSCLC, the investigators need epidermal     growth factor receptor (EGFR) mutational status of the tumor. But most patients do not give     us such information at the time of diagnosis, because it requires tumor tissue and some time     period for EGFR examination. So, investigators develop a protocol of 1st line gefitinib     treatment for NSCLC according to FDG-PET response. If a patient shows 20% or more decrease of     peak standard uptake value (SUV) after 1 week's gefitinib treatment, he or she will be     continued the treatment. If a patient shows less than 20% decrease of SUV, he or she will be     switched to other chemotherapy.   "
135545|NCT01510626|"     The long-term goal of the investigators study is to develop a better and safer treatment for,     and to potentially cure patients with single or multiple food allergies. The investigators     hypothesize that the application of this protocol will allow patients with severe and single     or multiple food allergies to be safely and rapidly desensitized.   "
135546|NCT01510613|"     The aim of the study is to evaluate the safety and efficacy of Pomalidomide and Dexamethasone     in patients who did not achieve a complete response after initial treatment with both an     alkylating agent (Melphalan or Cyclophosphamide) and Bortezomib. Patients who received 1     previous treatment without achieving a complete response (CR), but who could not be treated     with alkylators and/or Bortezomib due to contraindications, will be included.   "
135547|NCT01510600|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers in samples from patients with high-risk     neuroblastoma.   "
135519|NCT01510977|"     Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper     colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate     bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well     as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to     bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with     liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic     antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second     colonoscopy can be performed with either adding a colon cleansing solution immediately, or it     can be performed after a few days with colon cleansing agent together with prokinetics. These     different kinds of bowel preparations after first colonoscopy failure have not been compared.   "
135520|NCT01510964|"     The main aim of the study is to assess if a pre consultation intervention facilitates greater     participation of patients (and accompanying key persons when present) in the consultation     process by determining an increase in questioning and/or in the number of different illness     related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist.      Other aims are to assess the effect of the intervention on the oncologist's level of patient     involvement, on patient satisfaction and coping and to explore the role of key persons     accompanying the patient.      The investigators expect that patients who have the opportunity to rehearse their informative     needs before the consultation will ask a greater number of questions which in turn will     determine their greater involvement by the physician and a greater number of satisfied needs.     The investigators expect also that the straightforward use of a list of printed questions of     potential relevance for cancer patients and their companions at an early stage of illness, by     modifying the process of information exchange, increases their participation and satisfaction     with the consultation, with potential benefits for treatment adherence and consequently     treatment efficacy.   "
135521|NCT01510951|"     The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical     effects of AMG 811 following single subcutaneous dose administration in subjects with     moderate to severe psoriasis.   "
135522|NCT01510938|"     The purpose of this study is to assess the potential of probiotics in prevention of     respiratory tract infections and their complications in children   "
135523|NCT01510912|"     The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the     treatment of osteoarthritis pain of the knee or hip.   "
135524|NCT01510899|"     This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and     safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single     dose of RO4917838.   "
135525|NCT01510886|"     The main objectives of this study are to describe medical professionals responsible of the     management of patients with MDD in a representative region of Andalusia (in terms of type of     sites managing the disease, and referral to SC criteria); Describe MDD patient     characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated     to a higher incidence of referral from PC to SC.   "
135526|NCT01510873|"     Symptoms of Primary Immune Thrombocytopenic Purpura (pITP), such as spontaneous bruising,     menorrhagia, mucosal bleeding and other symptoms might significantly affect the HRQOL of pITP     patients. However, very little evidence exists on HRQOL outcomes in patients diagnosed with     pITP. The investigators project will aim at providing scientific community solid evidence     based data on the extent to which HRQOL is compromised and in which specific area.      The purpose of this study is thus to compare generic Health-related Quality of Life (HRQOL)     profiles of adult patients with primary Immune Thrombocytopenic Purpura (pITP) with that of a     matched Italian population control Group.   "
135527|NCT01510860|"     The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus     Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).   "
135528|NCT01510847|"     The study hypothesis is that treatment with oral Testosterone according to the study regimen     will improve glycemic control in T2DM Chinese males in Singapore as indicated by a reduction     in HbA1c levels at study day 90.   "
135529|NCT01510834|"     This project assesses the usability and feasibility of a multi-behavioral computerized,     tailored intervention (CTI) or expert system delivered via the Internet for veterans with     Post-Traumatic Stress symptoms. Three behavioral health risk factors, (1) smoking, (2)     depression, and (3) stress, that are associated with Post-Traumatic Stress Disorder (PTSD),     are included in the Computerized, Tailored Intervention (CTI) system. The project adapts and     modifies an existing CTI system built on the Transtheoretical Model of Behavior Change (TTM)     to make it relevant to a veteran population. The system has been successfully utilized with     general adult populations. The study utilizes methods that are characteristic of a product     development project. Each of the four project phases are sequential and build upon the     results of the previous phase. Phase 1 focuses on the review of current CTI programs on     smoking cessation, stress management, and depression prevention, and integrating them into a     multi-behavioral program for application with veterans. Phase 2 includes the development and     adaptation of text-based feedback messages and multimedia components for smoking cessation,     stress management, and depression prevention for veterans. Initial testing of the modified     CTI programs commences in Phase 3. Cognitive and usability testing with veterans are     performed, and additional modifications to the behavioral modules are made based on the test     results. Phase 4 focuses on a feasibility study to test the multi-behavioral CTI system with     veterans online.   "
135530|NCT01510821|"     This is a single center prospective study of 30 patients undergoing elective heart bypass     surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo     study is to evaluate the function of vein grafts from small tissue samples treated with a     pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the     veins in preparation of bypass grafting. It is unknown if different levels of pressure in the     syringe affect the vein or damage the vein. Small sections of tissue samples which are     normally discarded will be obtained immediately after retrieval from the leg and before     grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no     clinical endpoints in this study, however, clinical information will be obtained from the     Society of Thoracic Surgeons database and will include demographics, risk factors, and     perioperative outcomes.   "
135532|NCT01510795|"     Chronic allograft nephropathy is one of dominant causes of long term kidney transplant     failure. Its main histological determinant is interstitial fibrosis and tubular atrophy.     Mechanisms of these changes are multifactorial and are not completely elucidated. Epithelial     mesenchymal transition (EMT) might be one of the mechanisms. On molecular level role of renin     angiotensin aldosterone system (RAAS) has been recognized. Recently, mineralocorticoid     hormone aldosterone has been proposed as a possible direct contributor to the progression of     renal injury and fibrosis, beside his well known role as a regulator of extracellular fluid     volume and sodium and potassium balance. In this study the investigators will determine the     impact of mineralocorticoid receptor antagonist use on progression of chronic scores in     transplanted kidney over one year. The investigators hypothesis is that spironolactone use in     kidney transplant patients will slow down progression of chronic histological changes-     interstitial fibrosis, tubular atrophy and arteriolar hyalinosis.   "
135533|NCT01510782|"     To investigate safety and tolerability of BI 655064 in healthy male volunteers following     intravenous infusion of escalating single doses and following subcutaneous injection.     Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and     determination of the bioavailability of subcutaneous injections of BI 655064.   "
135534|NCT01510769|"     This study will compare the serum uric acid lowering effects, clinical benefits, and safety     of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous     gout.   "
135535|NCT01510756|"     This is a Phase 2 trial to evaluate the activity of sorafenib in relapsed or refractory CLL     patients with an iwCLL-WG indication to receive therapy.      Sorafenib is an orally active multikinase inhibitor, which targets the RAF/MEK/ERK signaling     pathway as well as several receptor tyrosine kinases. It is FDA approved for the treatment of     hepatocellular carcinoma and renal cell carcinoma. Preclinical studies in the investigators     laboratory demonstrated that sorafenib is cytotoxic to CLL cells.      The primary objective of the study is to determine the overall response rate of Sorafenib in     previously treated CLL patients. All patients will receive sorafenib at 400 mg twice daily     continuously for three months and then assessed for response. Responding patients may elect     to continue on treatment for an additional 9 months.   "
135536|NCT01510743|"     There has been no study comparing the complication rates between internal jugular vein     catheterization and subclavian vein catheterization when they are performed using sonographic     view. This prospective study would reveal the sort of complication and its rate.   "
135537|NCT01510730|"     The purpose of this study is to determine whether Helicobacter pylori eradication could     reduce the new tumor development after endoscopic resection of gastric tumor.   "
135538|NCT01510717|"     The purpose of this study is to compare the safety and efficacy of an investigational     multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.   "
135539|NCT01510704|"     To assess the efficacy and safety of different doses of APD421 in the prevention of     post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV.     Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any     surgical technique), cholecystectomy (any surgical technique) or other elective surgery     scheduled to last at least one hour from induction of anaesthesia), requiring at least one     overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past     history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use     for post-operative analgesia.   "
135540|NCT01510691|"     Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal     membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following     retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment     modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen     saturation. However, little information is available about the oxygenation and the blood flow     of the retinal vessels after vitroretinal surgery.      Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn     the most important factor for the development of macular edema. It is a major issue to     improve the oxygen situation and the blood flow of the retina and there are just a few not     satisfactory procedures available to overcome this problem. However, vitrectomy would be an     adequate therapy for many of these diseases, and it would be an appreciated side effect of     the treatment in almost every case.      To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes     after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular     edema following diabetic retinopathy or retinal vein occlusion.   "
135541|NCT01510678|"     Examine the effect of three different dietary messages on dietary intake and the health of     parents and their children.   "
135542|NCT01510665|"     This is a prospective, randomized, placebo controlled study with three parallel arms     examining the effects of magnesium supplementation in the second trimester of pregnancy.      Recent research has shown that supplemental magnesium can have beneficial effects, especially     in overweight individuals. Not only do many people have a magnesium deficient diet, there is     also evidence that magnesium can improve blood sugar levels. Due to the growing concern of     obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal     growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes.      In this study, 60 overweight and obese pregnant patients in their first trimester will be     enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg     elemental Magnesium), group B will receive dietary counseling about following a magnesium     rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine     specimens will be collected at three time points during the pregnancy to analyze changes in     levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal and     maternal complications of pregnancy will be noted, including maternal weight gain. At     delivery, patients will have a placental cord blood specimen and placental biopsy collected     for gene expression patterns and further analysis.   "
135543|NCT01510652|"     This investigation is designed with the hypothesis that using a quadripolar left ventricular     lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve     Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left     ventricular leads.   "
135548|NCT01510587|"     The main goal of this project is to develop, deliver, and assess the efficacy of a     parent-centered educational program (4-Health) designed to prevent preteen children from     becoming overweight.   "
135549|NCT01510574|"     Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An     important strategy in the prevention of deaths is the use of uterotonic drugs for PPH     prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is     economical, heat stable, has a long shelf-life, and can be taken orally.      The investigators envisage that the use of self administered misoprostol after home births     among mothers would be associated with a peri-partum fall in hemoglobin value of over 20%     (the outcome of a fall of 2g/dl will also be tested in the pilot).      The objective of the main study will be to assess the effectiveness and safety of antenatal     administration of misoprostol tablets (600mcg) for self administration immediately following     home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study     are to test the integrity of the study protocol, to test the randomization procedure, to     assess the acceptability of the intervention, to test the logistics of follow-up, to test the     data collection forms, to validate the quality of life questionnaire in this population and     to determine the recruitment rate to help study planning.   "
135550|NCT01510561|"     90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to     assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and     effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are     then followed weekly for 12 weeks and afterwards for up to 1 year.   "
135551|NCT01510548|"     Aims:      To study the efficacy and safety of adalimumab versus placebo in the treatment of acute disc     prolapse will be will be compared up to 12 months after the start of study drug treatment.      Study type:      A one year,randomized, placebo controlled double blind single center trial.      Patients and study drug treatment:      The study population consist of 99 patients with sciatica caused by herniated disc prolapse.      The study has 3 arms: 33 patients randomized to adalimumab 40mg every week, 33 patients     randomized to adalimumab 40mg every other week, and 33 patients randomized to placebo. Study     drug treatment period will be six weeks.      Methods:      Clinical evaluation, global assessments and Oswestry Disability Score and visual analog scale     (VAS) will be used as the evaluation of clinical results with the disc prolapse patients     confirmed by Magnetic Resonance Imaging. Health related quality of life will be assessed by     15-D questionnaire. Safety will be evaluated by medical examinations, adverse events (AE)     collection and laboratory measurements throughout the study period.   "
135552|NCT01510535|"     The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once     versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3     weeks in the treatment of patients with osteoarthritis of the knee.   "
135553|NCT01510522|"     This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare     the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients     treated with Glucophage tablets.   "
135554|NCT01510509|"     Even though the safety of drug eluting stents has been long established, in roughly 25% o     patients their implantation is not considered, for specifically clinical reasons (chronic     anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A     considerable percentage of these patients have diabetes mellitus, a well known risk factor     for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric     oxide have been described, causing it to be considered as a bioactive stent.      The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled     clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal     stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug     eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients     undergoing percutaneous coronary intervention.   "
135555|NCT01510496|"     The treatment of postoperative pain continues to be inadequate in the investigators practice     setting.      Inadequate pain treatment not only contributes to postoperative complications in the short     term but can also be a factor that favors the development of chronic postoperative pain and     diminishes long-term quality of life. Risk factors that can lead to a transition to chronic     pain need to be analyzed.   "
135556|NCT01510483|"     This study will test an 18-month intervention designed to increase physical activity, reduce     sedentary practices and promote healthy diets or reduce tobacco use and exposure among     preteens who obtain orthodontic care. Relevance: If successful, this study may inform     policies that would promote all specialists (orthodontists, physicians, general dentists) to     deliver brief counseling for diet, physical activity, and tobacco prevention.   "
135557|NCT01510470|"     The Astra Tech Osseospeed Profile Implant design when placed in the healed extraction site     maintains the marginal bone level   "
135558|NCT01510457|"     The patients are asked to take part in this study because you have chronic pain as a result     of knee osteoarthritis. This study is done to investigate the pain relieving effects of the     study drug Savella (milnacipran HCl) for people who experience chronic osteoarthritis pain.     The purpose of this research is to look at how the study drug can be used to benefit people     who experience osteoarthritis knee pain. This is a phase IV study done to study the safety     and effectiveness of the drug. At this point the drug is already approved by the Food and     Drug Administration for people with fibromyalgia but it has not yet been approved for people     with knee osteoarthritis.   "
146750|NCT01363427|"     The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine     in recently diagnosed patients with Morbus Crohn by retrospective data collection.   "
135559|NCT01510431|"     Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen     Crohn's disease patients at participating centers who typically have already demonstrated     good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and     in the view of the investigator, would not benefit significantly from other Crohn's therapies     but would benefit from use of PROCHYMAL.      The study is not placebo-controlled or randomized.   "
135674|NCT01508910|"     The purpose of the study is to assess the safety and efficacy of targeted intramyocardial     delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal     symptoms in subjects with refractory angina and chronic myocardial ischemia.   "
135560|NCT01510418|"     The goal of this pilot study is to understand the socialization of adult men with hemophilia     living in the United States and their quality of life in order to improve comprehensive care     for persons with congenital bleeding disorders. Studies in Europe suggest that despite     medical, surgical, and biotechnology advances in care for persons with the congenital     bleeding disorders hemophilia A and B, men with hemophilia have earlier work disability and     health-related lower quality of life than men of the same age who do not have hemophilia in     the general population. Congenital bleeding disorders are known to have medical and     psychosocial impact not only in school but also in other activities, e.g. participation in     sports beginning at a young age. The psychosocial impact of living with a congenital bleeding     disorder has been studied and described in childhood. The support relationships in childhood     include parents and primary family of origin and these supports are generally considered in     pediatric comprehensive care models. Support relationships in adulthood have not been well     described or studied. The role of spouse and significant others (SSO) of PWCBD in health care     is of interest for the delivery of adult comprehensive care as well as to understand their     contribution to the health-related quality of life of PWCBD. Additionally, this study seeks     to learn of the impact of congenital bleeding disorders for the SSO. The study uses     self-reported medical and social information questionnaires, health-related quality of life     surveys, and confidential interview. Results of this study may guide how comprehensive care     and support are provided to adult persons with congenital bleeding disorders by hemophilia     treatment programs. This study focuses on PWCBD with hemophilia A or B as a model for the     experience of persons with other congenital bleeding disorders.   "
135561|NCT01510405|"     The investigators have characterized in preclinical Non-Small Cell Lung Cancer (NSCLC) models     the proteomic expression profile associated with exposure to Aurora and Polo-like kinase     inhibitors. The identification of proteomic expression patterns in patients with NSCLC would     be an important step in defining the possible role of these agents as potential targeted     therapies for this clinically important disease. This study proposes to evaluate resected     non-small cell lung cancer specimens for these proteomic expression profiles.   "
135562|NCT01510392|"     The primary goal of the trial is to show that optical coherence tomography (OCT) technology     can be used to effectively screen for diseases of the eye including glaucoma, macular     diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is     usually accompanied by increased eye pressure. Macular diseases affect sharp, central vision.     Keratoconus is a disease that affects the cornea (clear surface covering the colored part of     the eye).   "
135563|NCT01510379|"     The effect a ReletexTM device has on postoperative nausea and vomiting when used with     ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved     wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to     decrease nausea and vomiting. The investigators will randomize 100 patients who are having a     fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or     Heller Myotomy for achalasia into two groups. A control group will receive scheduled     ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan     as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days.     These patients will also get scheduled ondansetron and phenergan as needed, like the control     group. The investigators will compare nausea, retching, and the amount of supplemental nausea     medication used between the two groups. The patients will be provided a diary to document     their nausea, retching, and medication use.      The hypothesis of this study is that use of the ReletexTM device will reduce post-operative     nausea and vomiting, and will reduce post-operative use of anti-emetic medications in     patients who have undergone foregut surgery.   "
135564|NCT01510366|"     Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the     objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated     Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).   "
135565|NCT01510353|"     The purpose of this study is to examine the impact of using a real time radiation exposure     monitoring device on the patient and operator radiation exposure during cardiac     catheterization. The hypothesis of the study is that use of a real time radiation exposure     monitoring device during cardiac catheterization will decrease both patient and operator     radiation exposure compared to no use of the monitoring device.   "
135566|NCT01510340|"     The purpose of this study is to evaluate the efficacy of an online virtual intervention in     optimizing adherence to antiretroviral medication intake among Persons Living with HIV     (PLHIV).   "
135567|NCT01510327|"     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo     atherosclerotic coronary artery lesions. The lesions are located in vessels that are     average-sized.   "
135568|NCT01510314|"     The clinical symptoms of septic complications (SC) (responsible for the majority of morbidity     in colorectal surgery) become apparent only 5-7 days after the operation, whereas the     efficacy of treatment depends on early diagnosis. By detecting such complications early it     could be possible to reduce their severity, the length of hospitalisation, repeat colostomy     and the number of readmissions. Our team has shown that C-reactive protein (CRP) > 125 mg/L     at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin (PCT) is a     marker of sepsis currently used in intensive care, but its use in the follow-up of elective     surgery, particularly colorectal surgery, has not been fully evaluated.      The aim of this study is to compare the ability of CRP and PCT to detect SC as early as     postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC)     after elective colorectal surgery.      Adult patients about to undergo elective colorectal surgery with anastomosis will be included     once they have given their written informed consent. Levels of CRP and PCT will be measured     the day before the surgery, then at D1, D2, D3 and D4. The clinical data (temperature,     recovery of bowel movement, pain, pain on palpation) will be recorded daily. Imaging     examinations will be performed at the discretion of the surgeon; the only obligation will be     to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 > 125 mg/L with no other     clinical anomalies. The discriminating ability (measured by the area under the ROC curve) of     CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be necessary     to show the superiority of PCT over CRP in clinical terms and with regard to the cost.   "
135569|NCT01510301|"     The purpose of this study is to examine if a mobile phone-based self-report system, using the     patient's own mobile phone, will improve adherence to treatment of hypertension and lead to     personal involvement of the patient in the treatment.   "
135570|NCT01510288|"     Ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4, and GVAX have     demonstrated anti-tumor activity in prostate cancer. Pre-clinical studies with this     combination have demonstrated potent synergy. The purpose of this study is to investigate,     using a phase-I 3+3 dose escalation design followed by an expansion cohort, the safety and     efficacy of combined treatment with GVAX and ipilimumab in castration-resistant metastatic     prostate cancer (CRPC) patients.   "
135571|NCT01510275|"     In a rehabilitation setting, respiratory muscle training with re-expansion techniques in     patients following cardio-thoracic surgery represents a consolidated intervention. New     devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an     effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators     study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent     history of cardio-thoracic surgery.   "
135572|NCT01510262|"     People who present repeatedly at Sexually Transmitted Infection (STI) clinics represent a key     population for HIV prevention intervention research. Despite their heightened risk there is     an absence of empirical research on strategies to intervene with repeat STI. Some STI-clinic     based behavioral HIV prevention studies, focusing on the general STI patient population, have     found that risk reduction interventions can reduce the incidence of a subsequent STI. Studies     have shown that expedited treatment for STI patients' partners can reduce subsequent STI and     enhancing partner notification can reduce risk for repeat infection. Those who go on to     experience repeat infections, after they are provided with risk reduction services, are the     focus of this project. Repeat STI literature noted, there have been no intervention studies     conducted to lower STI/HIV risk specifically among people who are presenting with repeat STI.      The proposed study develops a risk reduction intervention designed for STI repeaters and     evaluates the efficacy of this intervention and its cost-effectiveness. The investigators     expect that the intervention for STI repeaters will be significantly more effective than     standard care with regard to reducing participants' STI/HIV risks. However, even a     highly-effective intervention is unlikely to be adopted if the outcomes come at a high cost.     Administrators need to know how effective a new intervention is, but also if it is more     cost-effective than the program it replaces.      Cost-effectiveness information also is critical to justify the new intervention to     prevention funders (Milwaukee Department of Health), who are concerned not only with costs     and effects, but also with the tradeoff between them. The proposed study will provide the     comprehensive level of information about intervention effects and cost-effectiveness required     by administrators and resource allocation decision makers to determine whether or not to fund     or implement the intervention.      Hypothesis 1. The investigators expect a greater reduction in unprotected vaginal and anal     intercourse in the prevention case management compared to the standard care condition.      Hypothesis 2. The hypothesis that the case management group will have a lower STI     re-infection rate compared to the standard care group will be tested using each participant's     repeat STI status over the 12 month FU period.   "
135573|NCT01510249|"     Heel spur is a troublesome disorder. Its formation is accompanied by pain in the area of heel     and it makes walking limited or even impossible.      The aim of the study is to analyze analgesic efficacy of ultrasound and shock wave therapy in     patients with heel spur.      The study included 52 patients of both sexes, aged 38-86 (average 57.39) with plantar heel     spur confirmed radiographically. The patients were randomly divided into two groups;in Group     1 the patients underwent ultrasound procedure (10 treatments)and in Group 2 - radial shock     wave procedure(6 treatments). The researchers assessed pain three times (prior to the     therapy, after the first and then the second week of treatment). In order to do this they     used a modified form of the Laitinen pain indicators questionnaire (results expressed in     points) and VAS - visual analogue scale (results given in milimeters). The results were     statistically analyzed. In the studied periods of time a decrease in pain was observed (both     in the Laitinen questionnaire and in the VAS scale). The most rapid change was noted in both     the groups after the first week of treatment. Ultrasound and shock wave therapies show a     comparably significant analgesic efficacy in patients with heel spur. Shock wave therapy has     an advantage over ultrasound therapy. A smaller number of procedures is required to obtain     comparable results, which makes the therapy less expensive. No side effects were observed     during and after the treatment.   "
135574|NCT01510236|"     The overall aim is to evaluate the clinical efficacy and cost-effectiveness of a self-help     program via internet aiming at preventing development and maintenance of cancer-related     emotional distress among adolescents with cancer.   "
135575|NCT01510223|"     This study examined the effect of a 5-day HFD supplemented with specific fatty acids on     gastrointestinal transit, appetite, food intake and substrate utilization. Another novel     aspect of this chapter was examining whether a subsequent 5-day period was sufficient to     reverse the effects of high-fat feeding on the aforementioned parameters.   "
135576|NCT01510210|"     The objective of this study is to assess the risk profile in patients with atrial     fibrillation, which represents the degree of changes in the atrial tissue and which can help     predict in which patients rhythm control will be successful. This risk profile will consist     of a combination of underlying (heart) disease and risk factors, measurements obtained from     echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to     guide type of rhythm control therapy in individual patients with atrial fibrillation.   "
135577|NCT01510197|"     The objective of this study is to assess the risk profile in patients with atrial     fibrillation, which represents the degree of changes (remodeling) in the atrial tissue and     which can help to predict in which patients rhythm control will be successful. This risk     profile will consist of a combination of underlying (heart) disease and risk factors, as     measured with use of parameters obtained with echocardiography, circulating biomarkers and     other relevant clinical data. Ultimately this risk profile can be used to guide type of     (rhythm) control therapy in individual patients with atrial fibrillation.   "
135578|NCT01510184|"     The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with     observation alone in patients who are in PET-negative complete remission after first-line     R-CHOP or R-CHOP like therapy.   "
135579|NCT01510171|"     The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral     antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with     bivalirudin monotherapy.   "
135580|NCT01510158|"     This study that compare the serum uric acid lowering effects, clinical benefits, and safety     of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who     have had an inadequate response to allopurinol.   "
135581|NCT01510145|"     The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution     without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic     solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to     tolerability issues.   "
135582|NCT01510132|"     The purpose of this multi-center, open label, single arm, post-marketing surveillance study     is to assess the safety of Travacom in patients with open-angle glaucoma or ocular     hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other     intraocular pressure-lowering (IOP) medication and when use of Travacom is considered     appropriate.   "
135583|NCT01510119|"     This is an open labeled phase I dose escalation study of HCQ and RAD001 in patients with     advanced renal cell carcinoma followed by a Phase II trial of RAD001 with HCQ. The target     population are patients with one to three prior treatments for advanced renal cell carcinoma.     In the phase I portion a traditional 3+3 design will be used to determine the maximal     tolerated dose and/or recommended phase II dose for HCQ in combination with RAD001 po 10     mg/day.   "
135584|NCT01510093|"     This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles     of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with     continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous     glucose infusion. The order of treatment session will be randomised.      Hypotheses:        1. Secretion of endogenous insulin depends on exogenous insulin supply        2. Secretion of endogenous insulin is depends on plasma glucose levels   "
135585|NCT01510080|"     In order to meet an existing lack of empirical studies in the field of cognitive behavioral     therapy supervision, the present randomized controlled trial is aimed at comparing two     different types of supervision. This study compares computer-assisted live supervision and     delayed video-based supervision regarding efficacy and acceptance among therapists, patients     and supervisors. The efficacy of supervision is defined on different levels such as change of     psychotherapeutic competence, nondisclosure, self-efficacy, self-awareness of the supervisee     as well as therapeutic alliance, supervisory alliance and therapy outcome.   "
135586|NCT01510067|"     The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site     database between the University of Pennsylvania and the University of Texas Southwestern     (UTSW).   "
135587|NCT01510054|"     MiRNAs are single-stranded small non-coding RNAs that act on specific mRNAs to regulate the     gene expression. Studies have suggested that miRNAs influence cellular activities in the     uterus, including cell differentiation and embryo implantation.      In assisted reproductive cycles, controlled ovarian stimulation (COS) results in     supraphysiological steroid levels and is associated with very low luteinizing hormone     concentration during the luteal phase, the peri-implantation and implantation period. Luteal     phase support, administration of medication aimed at supporting the implantation process, has     been a routine practice in in vitro fertilization (IVF) clinics. Luteal phase support with     steroid hormone has been found to improve pregnancy rates when human menopausal gonadotropins     were used in conjunction with GnRH agonists for ovarian stimulation and IVF. Reports on     effect of steroid supplementation in GnRH antagonist protocols are limited.      The proposed project is an extension of our previous study on Endometrial Luteal Phase     Characteristics and Luteal Phase Support in Controlled Ovarian Hyperstimulation Protocols     with Gonadotropin Releasing Hormone Antagonists. The significance of this study is based on     the importance of luteal phase endometrial after COS for the process of implantation. The     availability of oocycte donors in assisted reproduction technology programs offers a unique     opportunity to study the impact of different stimulation protocols on the quality of the     luteal phase. In addition, the oocyte donor model may allow us to evaluate the impact of     different luteal support protocols directly on the endometrial preparation by histological as     well as biochemical markers.      Study design: Study subjects underwent ovarian stimulation according to a gonadotropin/GnRH     antagonist protocol. All donors had a baseline measurement of serum follicle stimulating     hormone (FSH) and estradiol levels on the second day of their menstrual cycles. Provided     serum FSH levels were less than 10mIU/ml and E2 levels were less than 60pg/ml, ovarian     stimulation was initiated with recombinant FSH. The daily dose was adjusted according to     follicular development by serial transvaginal ultrasound and serum E2 response. A daily     evening dose of ganirelix acetate was initiated on the 6th day of stimulation and continued     through the day of human chorionic gonadotropin administration. When at least three follicles     reached a mean diameter of 18mm, ovulation was triggered with a single dose of Human     chorionic gonadotropin (hCG). Sonographically guided transvaginal oocyte retrieval was     performed 34-36 hours after the hCG administration.      Thirty endometrial biopsies from oocyte donors on their COS cycles will be used for the     study. Study subjects have been randomized into 4 groups. Grp 1: day of retrieval, did not     receive any luteal-phase support, which serves as base line; grp2: 3, 5 and 10 days after     retrieval with no luteal phase support, which serves as control; grp3: 3, 5 and 10 days after     retrieval, luteal phase support with progesterone in the form of vaginal suppositories     starting from the day after retrieval; grp4: daily oral dose of 2 mg 17β-estradiol in     addition to the micronized progesterone. Immediately after the endometrial biopsy all     specimens were stored in liquid nitrogen tanks at -196°C.      Total RNA will be isolated and microarray will be performed using an Illumina miRNA     expression panel. Array results will be compiled and analyzed focusing on the following     aspects: the target genes of prominent miRNAs, miRNA profile in relation to target gene     pathways; miRNA expression profile in relation to endometrial dating and status; effect of     luteal phase support on miRNA expression after ovarian stimulation. Minimum of 3 miRNA arrays     will be run for each sample for the purpose of statistical analysis. A total of 30 arrays     will be needed for all samples from all groups.      In this study, the investigators pose three questions: 1) How many and what types of miRNAs     are in the endometrium during ovarian stimulation? This is to identify miRNAs and associated     target genes that are relevant for endometrium receptivity; 2) Do levels of miRNA expression     change during the luteal phase, or during the window of implantation? This is to examine the     dynamics of miRNAs that are associated with remodeling process of endometrium; and 3) Do     luteal phase support alter miRNA expression in the luteal phase? This is to investigate the     steroid effect on miRNA regulation. The investigators hypothesize that many critical genes     related to implantation are regulated by miRNAs. This research effort will potentially     advance our knowledge of endometrial characteristics after COS and the impact of sex steroid     supplementation. Overall the study should help better understand the genetic control of     implantation. Completion of this study may also provide measurable scientific evidence and     useful information for the management of IVF cycles.   "
135588|NCT01510041|"     In patients with chronic obstructive pulmonary disease (COPD) breaths at an abnormally high     lung volume causes the inspiratory muscle to operate at non-optimal lengths, which reduce     their maximal contractile forces. In addition, causes non thoraco abdominal synchronize,     reduced inspiratory muscle strength and is associated with dyspnea and decreased exercise     capacity. For these patients inspiratory muscle training (IMT) is a widely employed form of     rehabilitation also targeting the respiratory muscle. In addition, patients often experience     shortness of breath and a decline in exercise tolerance, resulting in disability in the     performance of activities of daily living (ADL). The aims of this trial are to evaluate the     effects of inspiratory muscle training associated with aerobic training on strength and     endurance of inspiratory muscle, thoracic abdominal synchrony, exercise tolerance and quality     of life patients with COPD. To compare the responses with the effects of aerobic training     plus exercises of the trunk and upper limbs, and stretching of large muscle groups of the     trunk. To compare difference in the perception of dyspnea during the ADL set (Borg Scale)     with perception of dyspnea self-reported in the Medical Research Council (MRC), the London     Chest Activity of Daily Living (LCADL) and the Pulmonary Functional Status and Dyspnea     Questionnaire - Modified version (PFSDQ-M) before start the protocol. To investigate changes     on perception of dyspnea (Borg scale), metabolic and ventilatory responses during a standard     set of ADL tasks after a physical training and to evaluate and compare changes on perception     of dyspnea. The hypothesis are that the ventilatory efficiency during the performance of ADL     and the dyspnea reported from borg scale, the LCADL and the PFSDQ-M that quantifies the     functional performance (change in activity levels) are improved during the IMT in conjunction     with general exercise training in patients with COPD. The MIT increases the strength and     endurance of inspiratory muscle, the exercise capacity and the quality of life compared to     the general physical training. However, compared to the thorax abdominal synchronizes, higher     modification is verified in the general physical training group with specific exercise to     torso, limbs and stretching of the higher muscle group.   "
135589|NCT01510028|"     The purpose of this study is to determine the safety of ascending doses of HGT-1110     administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with     metachromatic leukodystrophy (MLD).   "
135590|NCT01510015|"     This study evaluates the effects of psychological and pharmacological treatment of regular     users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The     participants will undergo psychological evaluation before and during treatment and follow up     at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 in order     to evaluate the effects of treatment on dopamine turnover in the brain. A control group of     psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from     Geha Hospital in Israel. It is predicted that successful treatment of regular users of     cannabis will be resulted in improvement in anxiety, depression and psychotic symptoms as     well as in upregulation of dopamine turnover in participants that will undergo brain imaging.   "
135591|NCT01510002|"     The purpose of this study is to determine whether prophylactic central neck dissection is     beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.   "
135592|NCT01509989|"     The treatment of systemic lupus erythematosus (SLE) may change in the future due to the     availability of new biological treatments, especially monoclonal antibodies in patients with     active disease. However, one of the main causes of treatment failure in SLE is the lack of     treatment adherence since drugs don't work in patients who don't take them.     Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and     investigators have demonstrated that patients who do not take HCQ for a long time have     undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe     non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active     disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients     with a SLEDAI ≥12.      Investigators will evaluate the importance of non-adherence to the treatment in a large     population of SLE patients with active disease. This will be done with blood HCQ monitoring     in a translational multicentric prospective study.   "
135593|NCT01509976|"     Triclosan (5-chloro-2 (22,4-dichlorophenoxy)phenol) is a broad-spectrum antibacterial and     antifungal agent that is found in thousands of common household products, including     deodorants, toothpaste, antibacterial soaps, cleaning products, kitchen utensils, bedding,     socks, trash bags. The benefits of triclosan have not been proven except in reducing plaque     and gingivitis when used in toothpaste. In this study, the investigators intend to look at     whether exposure to triclosan changes the colonizing flora of the skin, gut and mouth as well     as changes in certain blood hormone levels, including adipocytokines, androgens, and     inflammatory markers. Changes in the gut microbiota have been associated with a variety of     disease states such as inflammatory bowel disease, colorectal cancer. Additionally,     reductions in the microbiome diversity have been associated with obesity.   "
135594|NCT01509963|"     The purpose of this study is to prospectively evaluate the combined use of the MSKCC nomogram     (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients with     metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom     additional axillary lymph node dissection (ALND) could be avoided.   "
135604|NCT01509833|"     This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of     the late follicular phase administration of low dose hCG on oocyte maturity for ovarian     stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI)     treatment.   "
135606|NCT01509794|"     As simulation is now used in many post-graduate education and assessment domains, the     investigators want to learn about how autonomically engaged healthcare providers are with the     investigators computer simulation paradigm. The investigators are interested in the     relationship between autonomic arousal (as measured by heart rate variability and galvanic     skin response), self-report of engagement, and performance in the simulation and cognitive     debriefing.   "
135595|NCT01509950|"     Currently different materials are used to close the skin after a cesarean delivery, including     absorbable suture, non-absorbable suture and staples. It is not known what is the best choice     of material to close the skin after a cesarean section, but commonly staples or dissolvable     suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a     better cosmetic outcome than staples. The investigators hope to learn if there is a     difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene     suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to     look for differences in wound complications and patient satisfaction, as well as operating     and removal times. This knowledge will be important in helping practitioners choose the     closure technique at cesarean delivery.   "
135596|NCT01509937|"     It is hypothesized that bioimpedance spectroscope guided fluid management will help patient     reach euvolemic status, and increase long term survival.      Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia.     Observational data using BIA methods showed that hypervolemic patients on maintenance     hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided fluid     management can improve MHD patients' survival. The objectives of the BOCOMO study are to     evaluate the outcome of BIA guided fluid management comparing with standard care.      Design: This is a multicenter, prospective, randomized, controlled trial. Setting and     Participants: More than 1300 participants from 16 clinical sites will be included in the     study. The enrollment period will last 6 months, and minimum length of follow-up will not     less than 36 months. MHD patients aged more than 18 years but less than 80 years who had been     on MHD for at least 3 months and considered suitable candidates will be invited to     participate in the study. Participants will be randomized to BIA arm or control arm using 1:1     ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D     GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months in BCM     arm.      Predictors: BCM guided fluid management and fluid management using standard care.      Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint     between BCM arm and control arm. The secondary intent-to-treat analysis compares left     ventricular thickness, blood pressure, medication, and incidence and length of     hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke,     peripheral arterial disease will be used as composite endpoint.   "
135597|NCT01509924|"     The purpose of this study is to determine whether Physical Activation on Prescription can     help patients with TIA to become more physically active.      One group will receives Physical Activation on Prescription (PaP)and the other group will     receives usual care.      And to identify if persons with TIA presents with cognitive impairments.   "
135598|NCT01509911|"     TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The     investigational product Tl-118 comprises of four well-known active components. The therapy is     administrated at a unique dosing regimen that was found to be effective and advantageous in     terms of safety. The product is formulated as an oral suspension, conveniently administrated     by the patients at home and not requiring medical staff assistance. This Phase II clinical     trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated     Pancreatic Cancer patients   "
135599|NCT01509898|"     The aim of this study was to evaluate the effect of a dental water jet on initial     peri-implant disease resolution.   "
135600|NCT01509885|"     The main goal of this research is to understand the neuronal mechanisms that mediate the     development of spasticity and motor dysfunction after spinal cord injury. The investigators     examine how neurons and neuronal circuits in an injured nervous system adapt to produce the     uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients with     spinal cord injury. One of the neurons that the investigators study is the motoneuron that     excites the muscles of the limbs to produce movement. Previously, the investigators have     shown that after spinal cord injury, the excessive and uncontrolled activity of motoneurons     during muscle spasms is mediated, in large part, by the activation of calcium currents in the     human motoneuron. In human patients the investigators have used recordings from single muscle     fibres to estimate the contribution of these calcium currents in activating the motoneuron     during muscle spasms. In this proposal, the investigators study why motoneurons recover these     calcium currents and self-sustained activity after chronic spinal cord injury. Because the     calcium currents require the presence of the monoamine serotonin (5HT) to activate, and this     monoamine is greatly reduced after injury, the investigators examine if the calcium currents     recover because the 5HT receptors become spontaneously active without the need for 5HT to     bind to the receptor, which the investigators hypothesize to be one of the causes of     spasticity after spinal cord injury. This research will pave the way to develop new     pharmacological and rehabilitative therapies to both control spasticity after spinal cord     injury and augment residual motor movements.   "
135601|NCT01509872|"     The investigators are interested in knowing whether a group-based, trauma-focused     intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non     trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic     stress, depression and anxiety and conduct problems and increasing pro-social behavior among     war-affected children in the Democratic Republic of Congo.   "
135602|NCT01509859|"     The purpose of the study is to Compare the stability of the fracture and pain after surgery     by measuring the stride length and weight bearing on the operated leg. This study will     compare these parameters between two different proximal femur nails used for fixing hip     fractures.   "
135603|NCT01509846|"     This is a research study about an experimental (investigational) oral inactivated whole cell     Shigella flexneri 2a killed vaccine (Sf2aWC). Sf2aWC is a killed vaccine that is being made     to prevent disease from Shigella., which causes bloody, watery diarrhea. Infants and children     living in developing countries experience the greatest consequences of this disease. The     purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops     an immune response. About 82 healthy adults, ages 18-45, will participate in this study. This     study will require volunteers to stay in the research facility for several nights for the     first dose. Participants in Cohorts 2, 3, and 4 will not be required to stay overnight for     the second and third doses. Participants will be assigned to receive 1 of 4 vaccine doses by     mouth. Study procedures include: stool samples, blood samples and documenting side effects.     Participants will be involved in study related procedures for about 8 months.   "
135607|NCT01509781|"     The objective of this prospective randomized study is to perform qualitative and quantitative     comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus     the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex     mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum     from wound cavity, the extent of early postoperative analgesic requirements and quality of     life.   "
135608|NCT01509768|"     The purpose of this study is to evaluate the natural course of disease progression in     Mucopolysaccharidosis Type III (MPS IIIB) patients who are untreated to identify potential     surrogate endpoints that may be utilized in future treatment trials of MPS IIIB using     predefined assessments including standardized clinical, biochemical, neurocognitive,     developmental, and imaging measures.   "
135609|NCT01509755|"     This trial is conducted in Europe. The aim of this trial is to establish the dose response     relationship on glycaemic control of five dose levels of NNC90-1170.   "
135610|NCT01509742|"     This trial is conducted in Europe. The aim of this trial is to examine the effect of NNC     90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.   "
135611|NCT01509729|"     Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic     treatment.   "
135612|NCT01509716|"     Aims: The investigators' primary objective is to assess both perceived and actual disease     knowledge in local pre-dialysis Chronic Kidney Disease (CKD) patients. The investigators     hypothesize that actual disease knowledge is poorer than perceived. As the secondary     objectives, the investigators will also assess the HRQoL and examine the association between     level of knowledge and HRQoL in pre-dialysis CKD patients. The investigators hypothesize that     HRQoL of pre-dialysis CKD patients is poorer than that of the general population while     pre-dialysis CKD patients with greater disease knowledge have a better HRQoL than those with     poorer knowledge.      Methodology: A survey was developed to assess both perceived and actual knowledge on five     aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of CKD and     its complications and renal replacement therapy (RRT) options. For the assessment of HRQoL,     the following questionnaires will be used - Kidney Disease Quality of Life-Short Form     (KDQOL-SF) version 1.3, EuroQoL 5 Dimensions (EQ-5D), Family Functioning Measure (FFM), and     Oslo-3 Social Support Scale (OSS-3). All study questionnaires will be provided in 3 main     languages - English, Chinese and Malay. A standardized data collection form was developed to     retrospectively collect demographic and clinical information from the patients' electronic     medical records and patient charts. Descriptive statistics will be used to report all     results.   "
135613|NCT01509703|"     The aim of this study is to gain knowledge about effects of high flow transnasal insufflation     on various breathing parameters like intratracheal pressure conditions, CO2 elimination,     breathing frequency and tidal volume.   "
135614|NCT01509690|"     Patients with end-stage renal disease are most vulnerable in the early months following     hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore     Renal Registry showed high mortality rates in the first 3-12 months of dialysis.     Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months     of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the     United States.      Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a     renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic     is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to     4 months after HD initiation to focus on and streamline the management of dialysis issues and     complications. These interventions would help patients achieve goal therapeutic targets, as     well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes     and self-reported quality of life, and could result in economic and cost savings for the     patients and healthcare system. The purpose of this study is to determine if the     multidisciplinary, intensive and collaborative management of our multiethnic Asian patients     newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.      Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional     management. Information on demographics, medical/medication histories, laboratory data     (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and     diabetes), hospitalizations, deaths and medical costs will be obtained and compared between     the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of     Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support     Scale and Health Services Utilization questionnaires. Data collection will take place at     baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and     follow-up period of 1 year.   "
135615|NCT01509677|"     The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets     once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and     additional in sputum and blood serum. Also data on safety status will be obtained.      Patients to be included required to have moderate to severe COPD associated with chronic     bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks     maximum.   "
135616|NCT01509664|"     The investigators plan to test the effect of price reduction of fruits and vegetables and     non-caloric beverages on food purchasing, food intake, body weight, and body composition of     primarily single adult shoppers. One hundred subjects will be randomized to an experimental     or control group for a 4 month period. In the experimental group, there will be an automated     50% reduction in fruits vegetables and non-caloric beverages during the middle 2-month     period. The investigators expect to observe significant changes in food shopping and eating     behavior during this period, which should lead to body weight and fat loss. Some of these new     shopping patterns should persist in the last month of the study even though prices revert.   "
135628|NCT01509508|"     This trial is evaluating a public health intervention strategy trial which aims to reduce the     incidence of HIV at a population-level.      The proposed strategy is a two steps process:        -  Extensive HIV counselling and testing, and comprehensive prevention programme among a          target population        -  Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria.      The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of     all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the     population. This is a cluster randomised controlled trial with a total of 22 communities used     as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4     400 are expected to be HIV-Infected.   "
135629|NCT01509495|"     The purpose of this study is to measure impedance during inpatient treatment.   "
135659|NCT01509105|"     It is an observational multi-center study to assess the safety profile of Prevenar13 used     among Korean children in the routine clinical setting following a licensure and introduction     of the vaccine. This study is designed to fulfill regulatory requirement for any new drug     authorized by KFDA.   "
135675|NCT01508897|"     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two     formulations of liraglutide.   "
135617|NCT01509651|"     Although anticholinesterase reversal agents have been used in combination with     anticholinergic drugs for over half a century, it has been suggested that they should be used     with caution in patients with underlying cardiovascular disease. As sugammadex has no     endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This     selective relaxant binding agent is specifically designed to encapsulate rocuronium, which     can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as     the dose is increased.      Some reports, however, suggest that sugammadex may have increased time to effect in some     patient populations like the elderly, patients in intensive care and renal failure patients.     A less dynamic circulation and increased transfer time to the effector site in these subjects     are likely explanations for this effect. The present trial was designed to assess the safety     and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients     with heart failure.   "
135618|NCT01509638|"     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome     injectable suspension) to determine if total opioid consumption is reduced when using     EXPAREL, therefore possibly reducing total hospitalization costs.   "
135619|NCT01509625|"     This retrospective observational study is designed to assess the response to treatment with     fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of     progression free survival (PFS), overall survival (OS), and clinical benefit rate (CBR), in     post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were     treated with this medicinal product and at said dose after having progressed with a previous     anti-estrogen therapy. During this study, a retrospective data collection will be carried out     using the information contained in the Clinical History of said patients, provided that the     treatment with fulvestrant at a dose of 500 mg and LD-500.   "
135620|NCT01509612|"     The investigators aim to investigate the validity of their previous results in a randomized     prospective, placebo-controlled, double-blind, multicenter controlled evaluation of     questionnaires in patients with advanced malignant tumors. The investigators plan to compare     the treatment outcome (quality of life and survival) in tumor patients, receiving standard or     add-on homeopathic treatment.      The null hypothesis is that add-on homeopathic treatment does not create a benefit for     cancer patients. In addition the investigators evaluate survival time.   "
135621|NCT01509599|"     Leg vein circulation problems can damage the skin of the lower legs, especially around the     ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop.     Inflammation is often present in the damaged skin. This study will test whether using a     special low compression, cooling, boot-like gel wrap placed around the damaged skin of the     lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is:     A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation,     compression stockings) intervention compared to a low compression non-cryotherapy sham wrap     (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of     venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5     venous insufficiency.   "
135622|NCT01509586|"     This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers     who are not motivated to quit to test the effects of a marketed oral, non-combustible     smokeless tobacco product on cigarette smoking behaviors. It will also track the     participants' usage patterns of the smokeless tobacco product.      Half of the participants will receive a new, potentially safer tobacco product during the     first six weeks of the study, and half will not. During this six-week period, each     participant will complete three brief phone interviews. After this first six week period,     participants will complete 6 other brief follow-up interviews, where they will answer     questionnaires about their smoking habits.   "
135623|NCT01509573|"     The research will examine the following Specific Aims:      Specific Aim 1: To adapt a U.S.-developed family-focused and strengths-based prevention     program to the context of HIV/AIDS-affected families in Rwanda (the Family-Strengthening     Intervention in Rwanda or FSI-R) using prior qualitative findings and CAB input.      Specific Aim 2: To deliver the intervention to a small group of families to collect     preliminary data on intervention feasibility, acceptability, and to further refine the     intervention manual for the FSI-R.      Specific Aim 3: To conduct a pilot feasibility study of the FSI-R with 80 families.      In pursuit of Specific Aim 3, this research will (a) conduct a preliminary exploratory     analysis to examine the extent to which the FSI-R for HIV/AIDS-affected families is     associated with improved caregiver-child relationships using measures of family     connectedness, good parenting, and social support. Hypothesis 1: Participants in the FSI-R     will demonstrate increases in protective processes compared to usual care controls not     exposed to the FSI-R. It will also (b) conduct a preliminary exploratory analysis to     determine the extent to which improved caregiver-child relationships are sustained four     months after the conclusion of the FSI-R. Hypothesis 2: Four months after the conclusion of     the intervention, participants in the FSI-R will demonstrate increases in protective     processes compared to usual care controls not exposed to the FSI-R.   "
135624|NCT01509560|"     In this prospective study is to examine whether the use of everolimus in patients after     allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is     appropriate.   "
135625|NCT01509547|"     This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21.     After assessment and inclusion into the study, participants will be randomized to receive a     12-week double blind course of varenicline or placebo.   "
135626|NCT01509534|"     Study hypothesis: Dual-chamber pacemaker therapy with rate-hysteresis features is effective     in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of     reflex syncope diagnosed by means of carotid sinus massage, tilt table testing or implantable     loop recorder (ILR). The outcome is measured either by the time to first syncopal recurrence     or the total syncope burden.   "
135627|NCT01509521|"     The purpose of this study is to determine the impact of phenylephrine versus ephedrine on     organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The     organ perfusion is estimated by measuring the maternal cerebral oxygenation by     NIRS(Near-infrared spectroscopy)and the foetal heartrate.   "
135630|NCT01509482|"     Insulin resistance in men can be the underlying major factor in reproductive abnormalities (     chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic     ovarian syndrome ( PCOS ) in women.   "
135632|NCT01509456|"     Mainly due to the absence of gravitational forces in weightlessness, astronauts suffer from     an increased bone loss- negatively affecting health and vitality during a mission. The     development of effective countermeasures to this loss includes many different aspects like     sports but also nutrition.      Alkaline salts, abundant in fruits and vegetables, have shown to have positive effects on     markers of bone turnover of postmenopausal women but also men and younger adults. With the     current study the effects of a potassium bicarbonate supplementation added to a standardised,     strictly controlled, definite diet of healthy, young men, should be verified within 21 days     of 6°- HDT- Bedrest- the gold standard of simulating weightlessness within earthbound     conditions.   "
135633|NCT01509443|"     Overall goal: To apply the investigators' well defined simple, few-minute breathing/ mild     physical exercise program and evaluate its efficacy/benefits for the improvement of     clinico-immunological outcome in obese patients with asthma.      Rationale & Hypothesis: Different breathing exercise regimens currently recommended are not     well defined and in certain cases may worsen dyspnea or even trigger an asthma attack.     Therefore, it is important to evaluate the overall usefulness of a breathing exercise as a     therapeutic intervention of asthma. In this regard, the investigators have designed an easy,     few-minute breathing exercise program as a treatment modality for asthma and to evaluate its     efficacy in improving associated clinico-immunological symptoms. The investigators     hypothesize that the investigators' well-designed breathing/mild physical exercise     intervention for obese patients will help alleviate the stress and symptoms of asthma by     reducing the chronic low-grade systemic inflammation and thus potentiate the beneficial     outcome of medication to render a better control over the disease and to improve the quality     of life in obese patients.      Clinical relevance/Significance:      The investigators expect that their exercise module will help reduce inflammation caused by     asthma, and thereby relieving symptoms of asthma. If successful, this would allow regular     individualized exercise module to be recommended as a part of therapy for people with asthma,     which could possibly reduce the dosage as well as frequency of taking medicine that they     need.   "
135634|NCT01509430|"     Head and neck cancer patients often experience a critical weight loss of around 10% following     radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of     mortality, lowers muscle strength and functional performance. The purpose of this study is in     a randomized controlled trial to investigate the effects of progressive resistance training     (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck     cancer survivors. The investigators hypothesize that PRET has a positive effect on all     primary endpoints and increases muscle mass, muscle strength and functional performance.   "
135635|NCT01509417|"     The objective of this study is to scientifically evaluate the ability to discharge patients     based on feeding schedule comparing ad lib feeds to our current scheduled regimen.      The hypothesis is that patients may be able to be discharged sooner with ad lib feeds.   "
135636|NCT01509404|"     The purpose of the study is to assess the incidence and severity of late Cytomegalovirus     (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and     200 days and after 200 days post-transplant in patients treated with valganciclovir per     package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant     versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam     100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.   "
135637|NCT01509391|"     In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin     in patients with chronic hepatitis c infection and liver cirrhosis. The investigators     hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in     patients infected with hepatitis c.   "
135638|NCT01509378|"     The aim of the study is to characterize and quantify the relative effectiveness and     contribution of implantable cardioverter defibrillator (ICD) therapy to the clinical outcomes     under the conditions of daily practice.      Swiss, multicenter, prospective, observational study.   "
135639|NCT01509365|"     The purpose of the study is to determine whether administration of 150 mg clopidogrel is     effective in reducing the one-year incidence of thromboischemic events in patients with high     on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population     overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.   "
135640|NCT01509352|"     This is a prospective trial of the utility of esophageal stitches during fundoplication.      The hypothesis is that recurrence rate may be different with or without the esophageal     stitches.   "
135641|NCT01509339|"     The purpose of this study is to determine the pharmacokinetics and safety of inhaled     vancomycin in patients with cystic fibrosis.   "
135642|NCT01509326|"     This study will investigate the effect of chiropractic treatment with and without the use of     an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups     with and without the pillow and will be followed for five weeks. The primary outcome measure     will be headache frequency. The investigators predict that the group using the pillow on a     daily basis will demonstrate significantly greater decrease in headache frequency over a     5-week interval.   "
135643|NCT01509313|"     Outpatient polyp treatment can be performed in a few different ways but generally involves     passing a special type of hysteroscope (3-6 millimetre in diameter) into the womb through     which specifically designed miniature operating instruments are passed to remove the     polyp(s). At present the most commonly used instruments use an electrical cutting edge.     However, a new instrument using a mechanical cutting edge has come to market. In patients     having a general anaesthesia the mechanical cutting instrument has been shown to be easier to     learn, more effective at completely removing polyps and quicker. However, the instrument is     slightly larger, which could potentially cause more discomfort and prolong the procedure in     the outpatient setting. Therefore, the investigators want to compare the electrical and     mechanical instruments for speed, completeness of polyp removal and patient acceptability.   "
135658|NCT01509118|"     Arterial and venous thromboembolism represents one of the most common preventable health     problems. Patients undergoing surgery, especially hip fracture surgery are at high risk for     deep vein thromboembolism (VTE) without thromboprophylaxis. In the absence of prophylaxis,     the incidence of fatal pulmonary embolism (PE) after Hip Fracture Surgery (HFS) is reportedly     4%-12%. Provision of thromboprophylaxis to all patients who undergo HFS is recommended.   "
135644|NCT01509300|"     RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide     and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the     setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition,     T-cell depletion may contribute to prevent developing severe acute graft versus host disease     (GVHD) in haploidentical transplantation.      PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine,     cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical     donors in treating patients with acute leukemia and myelodysplastic syndrome.   "
135645|NCT01509287|"     This study focuses on the genetics and metabolism of Donnai-Barrow Syndrome (DBS).   "
135646|NCT01509274|"     The purpose of our study is to determine whether one injection with plasma into the origin of     the plantar fascia is an effective treatment of plantar fasciitis.      90 patients will be randomized into three groups. 30 patients will be treated with one plasma     injection, 30 patients will be treated with one injection with saline and 30 patients will do     physiotherapy and use heel cups. The two groups who receive injections will do the same     physiotherapy and use heel cups, as the conservatively treated group.      Both groups randomized to receive an injection will have a 10 ml blood sample taken from     their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are     added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to     receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The     injection into to the origin of the plantar fascia i done 10 minutes after the sample of     blood is obtained. The content of the syringe i blinded to both the investigator and the     patient.      The injection i performed from the medial aspect of the heel under guidance of ultrasound. No     local/systemic analgetic is used. The content of the syringe is spread using peppering     technique into the origin of the plantar fascia.      Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The     questionaires will be Foot Function Index and SF-36 as well as questions about their use of     analgetics, use of heel cups and intensity of their physiotherapy   "
135647|NCT01509261|"     This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive     esophagitis and resolution of heartburn.   "
135648|NCT01509248|"     1. Population pharmacokinetics : The purpose of this study is           - to investigate the population pharmacokinetics of theophylline in premature Korean          infants and to assess the influence of demographic and clinical covariates.        2. Metabolomics : The purpose of this study are             -  to predict serum theophylline levels and to assess CYP1A2 activities in premature               infants by analyzing urinary metabolites of theophylline             -  to examine which factors affect clearance of theophylline and CYP1A2 activity in               premature infants   "
135649|NCT01509235|"     In the current study, we designed a cross-over, open label, randomized controlled clinical     trial that aim to investigate the superiority of physical exercise coupled with self drainage     to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children     undergoing physical exercise coupled to self drainage will increase the amount of expectorate     secretions compared to conventional CP course, while being more satisfied and without     worsening their pulmonary function status.   "
135650|NCT01509222|"     The main objective of this study is to investigate the effect of a personalized nutrition     intervention on the dietary pattern of apparently healthy adults with one or more children     aged 4 to 12 years.   "
135651|NCT01509209|"     The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the     treatment of vasomotor rhinitis   "
135652|NCT01509196|"     The purpose of this study is to evaluate pharmacokinetics and safety after oral     administration of HIP0901 capsules and Lipidilsupra tablets.   "
135653|NCT01509183|"     Asthmapolis is collaborating with Catholic Healthcare West (CHW) to carry out a focused     demonstration project to evaluate the effectiveness and potential cost savings of a     deployment of the Asthmapolis approach to asthma management. The Asthmapolis goal is to bring     together the best technology and asthma insight in order to provide CHW with an engaging,     data-driven chronic care program to improve asthma management and lower healthcare     utilization costs, and to respond to prevention-focused reforms to health insurance laws.      This project has been designed to implement and evaluate a data-driven program to improve     asthma management and control and lower direct costs through reductions in healthcare     utilization. This program has been developed by Asthmapolis and has gone through preliminary     testing. Each subject participating in the study will receive an Asthmapolis device, which     captures the time and location of use of inhaled short-acting bronchodilators over a     twelve-month period. This information is processed and delivered at regular intervals to the     patient and his or her provider to support improved asthma management.      The purpose of the study is to evaluate the impact of the adoption of the Asthmapolis system     into a healthcare organization, and to provide sufficient information to inform decision     making for potential future adopters. The researchers believe that the Asthmapolis system has     the potential to improve asthma control by providing rescue inhaler actuation data and     tailored asthma management tips to patients with uncontrolled asthma, and rescue inhaler     actuation data to their providers. Improvements in asthma control should be reflected in     reductions in healthcare utilization for asthma, and potentially for general healthcare     utilization. Reductions in utilization would result in lower healthcare costs. The study has     been designed to capture data on individual subject asthma control, and changes in     utilization and costs over a one-year introduction period.   "
135654|NCT01509170|"     The aim of this study is to identify factors associated with hyponatremia among patients     hospitalized in the internal medicine ward. Consequtive patients hospitalized because of     hyponatremia will be recruited. Follow up will include clinical factors such as background     diseases, complete drug history, blood tests including Biochemistry tests (Sodium, renal     function), endocrinological evaluation, thyroid function tests, cortisol,urinary sodium on     addmition. One month following discharge follow up Sodium level will be taken.   "
135655|NCT01509157|"     The investigators have developed a unique Remote & Safety diabetes management system (MDRS)     that offers real-time remote monitoring and control of glucose levels. The system allows the     supervising personal to alarm the patient and intervene in cases such as pending     hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility     study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in     children and young adults with type 1 diabetes.   "
135656|NCT01509144|"     Objectives:        -  To assess the safety of three priming immunisations by nasal route followed by two          booster immunisations by intramuscular route        -  To assess immunogenicity responses induced by the vaccine.   "
135657|NCT01509131|"     It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar     bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and     compliance of the two reduced volume PEG-based bowel preparation will be also compared.   "
135660|NCT01509092|"     The purpose of this study is to compare the anatomical and visual recovery of eyes with     traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.   "
135662|NCT01509066|"     This study will be a 6-month intervention that is examining how different dietary approached     may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy,     particularly by measuring changes in weight. Participants will be randomly assigned to     following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight     loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat,     low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products     (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits,     vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic     index, which means you will be asked to favor foods that don't cause a quick rise in blood     sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will     receive counseling and supporting materials on the dietary approach you are assigned to     follow. Both diets are safe and have shown to be effective ways to assist with achieving a     healthy weight. The investigators hypothesize that both groups will see improvements in     weight and fertility with possible greater improvements seen among participants in the vegan     group.   "
135663|NCT01509053|"     The purpose of this study is to compare retrospective hospitalization rates of schizophrenic     patients treated with oral antipsychotics to prospective hospitalization rates of these     patients treated with IM depot aripiprazole.   "
135664|NCT01509040|"     ﻿The purpose of this study is to assess the feasibility of hemofiltration in patients     resuscitated from cardiac arrest. Cardiac arrest is the loss of mechanical activity of the     heart including the loss of detectable pulse, or spontaneous breathing. When heart function     is restored, the cells of the body release molecules into the blood that cause inflammation,     unstable blood pressure, organ dysfunction and death. Hemofiltration is a technique of     washing the blood to remove fluid and molecules from it. Hemofiltration is a proven therapy     for renal failure, but is considered investigational for treatment after resuscitation from     cardiac arrest. Some experts believe that hemofiltration after heart function is restored can     remove inflammation from the blood, maintain blood pressure and organ function. Others     believe that intravenous fluid and medications are sufficient to maintain blood pressure and     organ function. Since the inflammation that occurs after restoration of heart function lasts,     the investigators continue hemofiltration for up to 48 hours. Whether hemofiltration or     intravenous fluids and medications is better is not known. The investigators are checking if     they can wash the blood of patients resuscitated from cardiac arrest before the investigators     can begin a large randomized trial to test whether hemofiltration improves their outcome.      The investigators are testing this by randomly allocating patients resuscitated from cardiac     arrest to receive low volume hemofiltration, high volume hemofiltration, or intravenous     fluids and medications alone. The null hypotheses are that less than 80% of eligible patients     will be enrolled, and that less than 80% of enrolled patients will undergo low-volume or     high-volume hemofiltration (HF) for at least 80% of 48 hours.   "
135665|NCT01509027|"     Hyperphosphatemia is a common and severe complication in chronic kidney disease patients     treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the     cornerstones in the prevention and treatment of this complication. However, noncompliance is     an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial     proportion of hemodialysis patients. The present study aims at identifying risk factors for     non compliance and also test the hypothesis that compliance can be improved by education     patients on the consequences of hyperphosphatemia and the importance of diet and phosphate     binder therapy.   "
135666|NCT01509014|"     Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent     to statin therapy within the first year of starting. Due to their accessibility and frequent     patient contact, pharmacists are well-positioned to improve medication adherence.      The purpose of this study is to determine whether a simple intervention by community     pharmacists can improve statin adherence in new statin users.   "
135667|NCT01509001|"     Aim:      The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on     vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type     2 diabetes.      Methods:      A prospective study will be performed in 20 uncontrolled patients previously treated with     dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8     mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to     the alternative treatment for an additional 4-month period on similar dosage schedule.        -  The following variables were assessed before (basal values) and after 4 months of each          treatment period:             1. Hormonal and metabolic determinations: fasting plasma glucose, insulin,               catecholamine, lipid profile and HbA1 levels.             2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity,               platelet aggregation, fibrinogen and plasminogen levels.             3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at               the end of each treatment period, a 12-hour metabolic profile including               measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at               fasting and every 2 hours (7:00 am to 7:00 pm)will be done   "
135668|NCT01508988|"     The primary objective of this study is to evaluate the safety and tolerability of ascending     single doses of ONO-9054 administered as a single drop in healthy adult subjects. The     secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its     metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.   "
135669|NCT01508975|"     The investigators hypothesize that consumption of either white or brown rice will be more     satiating than glucose control.   "
135670|NCT01508962|"     The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early     ALS in whom some areas of the body are not yet affected.   "
135672|NCT01508936|"     The primary objective of the study is to characterize the efficacy of reslizumab treatment,     at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in     improving pulmonary function in relation to baseline blood eosinophil levels in patients with     moderate to severe asthma, as assessed by the change from baseline to week 16 in forced     expiratory volume in 1 second (FEV1).   "
135673|NCT01508923|"     This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC     90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin     secretion in subjects with type 2 diabetes.   "
135676|NCT01508884|"     Despite the WHO International Health Regulations Emergency Committee declared an end to the     2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has     affected more than 214 countries with at least 18000 deaths [1]. Patients with chronic     underlying illness and extreme of ages are at risk of developing severe disease and     complications [2-3]. Resistance to oseltamivir has also been reported [4]. Therefore,     vaccination with the 2010/2011 trivalent influenza vaccine (TIV) with the 2009 H1N1-like     virus incorporated will be the best protection against the influenza infection, especially     among the at risk population. Recent study on dose sparing seasonal influenza vaccine     delivered via a novel intradermal microneedle has demonstrated good immunogenic responses     similar to full-dose intramuscular vaccination [6]. Poor immunogenicity of the H1N1 2009     component of the trivalent influenza has been reported [7].      Study has also suggested the combined intradermal vaccination with local stimulation of     dermal antigen presenting cells by applying imiquimod cream (Aldara) to the injection site,     which activate antigen presenting cells (APC) through the toll-like receptor 7 (TLR7) may     produce better immunogenicity [8].      Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma.     Scientific evidence has demonstrated that after treatment with imiquimod, the antigen is     processed and presented to cells of the adaptive immune system leading to clearance of the     virus and subsequent clearance of the lesions [9]. In addition to functional maturation,     imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes     [10,11]. Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with the     antigen of interest, has shown to induce enhanced responses towards the administered antigen     [12].      We therefore performed a prospective, double blind, randomized controlled study to compare     the safety and immunogenicity between intradermal 2011/2012 TIV immunization with     pretreatment of imiquimod cream and conventional full dose intramuscular 2011/2012 TIV     immunization with pretreatment of aqueous cream as control.   "
135677|NCT01508871|"     This study will evaluate the relationship of markers of cardiac activation and their     determinants. The hypothesis is that these markers will be interrelated.   "
135678|NCT01508858|"     This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide     changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a     combination contraceptive drug (Neovletta®).   "
135679|NCT01508845|"     This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs.     poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken     after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat     is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will     be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA     ratio.   "
135680|NCT01508832|"     The duration of the autonomic (sympathetic) block will last longer than the sensory block.     The duration of the increased perfusion index will last longer than either the sympathetic or     sensory block.   "
135681|NCT01508819|"     Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most     difficult clinical challenges in medicine. There are few data to help guide clinicians in     this area: estimates of the benefits of ICU admission, especially in the very elderly, are     sparse. Rates of ICU admission of very elderly thus vary widely by hospitals.      The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of     patients over 80 arriving in Emergency Departments (ED) with conditions that potentially     warrant ICU admission and their outcome six months after ED visit. Overall rate of patients     deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged     from 5% to 38% across the participating centers. This variability persisted after adjustment     for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The     analysis also revealed that high functional status prior to ICU visit, good nutritional     status as assessed by an emergency physician and the absence of cancer were of good prognosis     for outcome six months after ED visit. Only 23% of patients visiting the ED with a     life-threatening condition and all positive prognostic factors mentioned above were admitted     to an ICU in the ICE-CUB1 study.      Hypothesis Elderly patients visiting the ED with a life-threatening condition, high     functional status prior to ICU visit, good nutritional status as assessed by an emergency     physician and no cancer will potentially benefit from ICU care and should thus be admitted.      Main objective Determine whether a strategy consisting of recommendations of ICU admission of     all patients over 75 visiting the ED with a life threatening condition, no cancer, good     functional and nutritional status prior to ED visit decreases the mortality of these patients     six months after ED visit.      Secondary objective : Assess the impact of the strategy on:        -  In-hospital mortality        -  Rate of ICU admission        -  Place of living and quality of life six months after ED visit      Primary outcome :Mortality six months after ED visit Secondary outcomes        -  In-hospital mortality        -  ICU admission        -  Change in functional status six months after ED visit        -  institutionalization        -  Quality of life six months after ED visit   "
135682|NCT01508806|"     This trial is conducted in Oceania. The aim of this trial is to assess whether dose     adjustment is required for patients with renal impairment by investigating the     pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.   "
135683|NCT01508793|"     The proposed study aims to determine whether an intervention to increase sleep in school-age     children is associated with positive changes in eating, activity behaviors and zBMI. One     hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly     assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce     a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in     sleep). Families of children in the optimize sleep group will be taught effective behavioral     strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month     follow-up, the following will be gathered: sleep duration (measured by actigraphy), food     intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry),     the relative reinforcing value (RRV) of food (measured using a validated experimental     paradigm), and measured child height and weight.   "
135684|NCT01508780|"     It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular     remodeling. The investigators believe that this study will help document the nature of     beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in     response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular     structure and function accompany clinical improvement.   "
135704|NCT01508520|"     Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and     microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI     for differential diagnosis among early gastric cancers (EGC) have not been fully     established.The study is based on the hypothesis:        1. ME-NBI is useful in distinguishing EGC from other gastric lesions        2. ME-NBI is useful in further differential diagnosis among EGCs.   "
135685|NCT01508767|"     Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone     tube) placed in the bladder at the time of operating to monitor kidney function during     surgery and in the post-surgery period. Such patients will also have an infusion into the     spine, known as an epidural, after surgery to provide them with continuous pain relief.     Urinary catheters should be removed as early as possible once they are no longer required to     facilitate patients becoming mobile after surgery and to reduce the risk of patients     developing a urinary tract infection.      Traditionally these catheters are not removed until the patients epidural infusion is     withdrawn, as in theory to do so would predispose the patient to developing acute retention     of urine due to lack of sensation when the bladder is full. The investigators hypothesis is     that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal     surgery in patients receiving epidural pain relief without a significant increase in rates of     urinary retention.   "
135686|NCT01508754|"     The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure     (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive     patients with moderate-severe obstructive sleep apnea syndrome (OSAS).   "
135687|NCT01508741|"     PURPOSE: The purpose of this investigation is to determine if a relationship exists between     the administration of a dietary supplement containing 5-ALA and sleep and mood.      HYPOTHESIS: There are several possible mechanisms for improvement in sleep and mood. In one     study involving test mice, researchers found that the regular administration of 5-ALA     appeared to raise serotonin levels in the brain. One hypothesis is by increasing serotonin     levels, 5-ALA may contribute to improvements with sleep, along with additional improvements     in mood, calmness, irritability and coping abilities. 5-ALA may also support hormonal     regulation, including melatonin, in the pineal gland and corticosteroid regulation in the     adrenal glands.      Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism     of cells, such that its own circadian rhythms are better defined. 5-ALA may support neuronal     function and assistance with mental energy needed to deal with stress in daily life,     producing better feelings of coping, less irritability and lowering an individual's     feelings of fatigue, all of which may contribute to a reduction of pessimism regarding     the ability to deal with daily tasks.      DESIGN: This will be a double-blinded, randomized parallel-group comparison study.      SAMPLE: 40 participants will be randomized to the following 2 study groups for each outcome     variable (Sleep and Mood): Control Group - 20 participants and Intervention Group - 20     participants. A table of random numbers will be used to assign the participants.   "
135688|NCT01508728|"     Ortheses are commonly used for the repair of damage to the musculoskeletal system. However,     immobility, by itself, causes serious side effects that require long and costly     rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the     proprioceptive and tactile flow in order to maintain the activity of their host brain areas     and thus reduce significantly the usual therapy duration. The clinical study Orthosens will     evaluate the efficacy and safety of the Sensory Feedback Ortheses.   "
135689|NCT01508715|"     The purpose of this study is to compare two different physical therapy exercise programs in     persons who have shoulder pain in order to determine if they have a different affect on pain     level and ability to use the injured shoulder after treatment. Both exercise groups will     attend physical therapy for an hour,two to three times a week, for eight weeks. The first two     weeks of therapy sessions will involve learning the exercises and testing to determine what     weight to use during exercises. One group will perform a traditional therapy exercise program     for shoulders using hand weights. The other group will perform a version of the same shoulder     exercises but with a different exercise technique. Exercises in both programs are part of the     standard of care for shoulder impingement in physical therapy but one program concentrates on     the lowering portion of the exercise (eccentrics) while the other emphasizes the lifting     portion of the exercise (concentrics). Both groups will perform the same warm-up, stretching,     and cool-down exercises. Participants will also be required to perform a daily home exercise     program of stretches and range of motion that will take about 20 minutes to complete.     Exercise testing will determine the hand weight resistance used by each person during their     therapy sessions and re-testing will occur every two weeks to determine any changes in the     weight used for the exercises to keep them challenging. Pain level, ability to use the     injured arm for daily activities, strength, and amount of movement in the shoulder, will be     measured at the start of physical therapy and after five and eight weeks (end of study) of     the exercise treatments. A concurrent study investigating the reliability of the shoulder     motion and strength measurements used in the larger study will also be performed.      Research hypotheses:        1. Adults with shoulder pain who complete the eccentric progressive resistive exercise          intervention will demonstrate significantly greater improvements in the outcome measures          at three weeks, earlier in the intervention, than the concentric progressive resistive          exercise intervention group.        2. Adults with shoulder pain who perform progressive resistive exercise interventions,          regardless of contraction type, will demonstrate significant improvement in the shoulder          outcome measures at three and six weeks of intervention.   "
135690|NCT01508702|"     This study will assess the serum uric acid lowering effects and safety of lesinurad compared     to placebo in patients who are intolerant or have a contraindication to allopurinol or     febuxostat.   "
135691|NCT01508689|"     The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars     will increase calcium intake in healthy adult women.   "
135692|NCT01508676|"     The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain     felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2 weeks.      The U.S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis     (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain.      The research study will compare Pennsaid to placebo.   "
135693|NCT01508663|"     The primary purpose of this study is to determine whether PCI added to OMT could be superior     over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in     elderly patients with coronary artery disease (CAD) during the additional 12 months.   "
135694|NCT01508650|"     Rehabilitation and Exercise Training after Hospitalization: Assessing Benefit in Acute Heart     Failure (REHAB-HF) pilot is a multi-site, randomized clinical pilot study designed to     establish the feasibility of conducting a larger clinical trial to address the hypothesis     that, in addition to standard care, a novel, progressive, multi-domain 3-month rehabilitation     intervention administered to elderly patients with acute decompensated heart failure (ADHF)     will improve key clinical outcomes, including the rate of rehospitalization and death,     physical function, and quality of life.   "
135705|NCT01508507|"     Various field studies has found that the modified , bivalent, whole cell - based oral cholera     vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 % in     earlier clinical trials. However, the effectiveness of the vaccine in real life situation     using the public health system is unknown. It is critical to follow up in the same     population, where pilot introduction of OCV was introduced and evaluate vaccine proactive     effectiveness at individual as well as at population level. The follow - up and determination     of effectiveness of mass OCV vaccination was requested by State Government.   "
135695|NCT01508637|"     Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated     diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system     a trial of alpha-blocker terazosin is also used. Each participant completes four study     sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at     300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure);     2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air     plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery     ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that     DE exposure will be associated with increased blood pressure, decreased brachial artery     diameter, and increased circulating endothelins, and that these effects will be attenuated by     terazosin administration.   "
135967|NCT01505062|"     To evaluate the safety and tolerability of ascending doses of subretinal injections of     UshStat in patients with Usher syndrome type 1B.      To evaluate for possible biological activity of UshStat.   "
135696|NCT01508624|"     This research will evaluate the impact of interventions to improve pain relief and recovery     following office based surgery.      There will be three phases to this research. The first phase will focus on predicting     recovery from office based vein surgery using a multiple regression analysis.      Phase two will incorporate a randomised controlled trial to compare the effectiveness of a     range of interventions in anxiety and pain reduction and recovery for office based vein     surgery patients.      The final phase of the investigation will utilise qualitative methodology to explore     patients' experiences of each intervention and their opinions about what was and was not     effective.   "
135697|NCT01508611|"     This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the     treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent     molars compared to a control group that performs only the cross-toothbrushing technique and     evaluate the acceptability and satisfaction of patients and responsible for the application     of the solution cariostatic.   "
135698|NCT01508598|"     Identification and validation of early chronic disease biomarkers in children is of paramount     importance especially in the burgeoning arena of pediatric obesity research. Despite the     presence of risk factors, few obese children develop overt cardiovascular disease (CVD) early     in life. However, because CVD is a cumulative process occurring over time, identifying the     earliest signs in order to intervene sooner may have a large impact on slowing its     progression. Endothelial activation is one of the earliest detectable signs of the beginnings     of CVD. However, accurately quantifying endothelial health in children has proven to be a     major challenge. Direct measures of endothelial cell biology, such as circulating endothelial     cells (CEC) and endothelial microparticles (EMP), have been extensively studied in adults and     are associated with vascular diseases, CVD risk factors, and CVD events. Despite being     well-validated in adults, CEC and EMP have not been formally evaluated as disease biomarkers     in children and adolescents. Pediatric obesity is an ideal condition in which to validate CEC     and EMP as disease biomarkers since adiposity in childhood is associated with CVD, type 2     diabetes mellitus, and premature death, later in life. The investigators primary focus in     this study will be the evaluation of CEC and EMP as biomarkers of CVD risk and whether     substantial changes in weight affect these biomarkers. The investigators propose to evaluate     the change in levels of CEC and EMP in response to substantial weight loss in 32 adolescents     with extreme obesity undergoing elective, clinically-indicated bariatric surgery.   "
135699|NCT01508585|"     Bariatric surgery is the most effective treatment for patients with extreme obesity.     Psychological interventions are not routinely offered in Bariatric Surgery Programs.     Preliminary evidence suggests that Cognitive Behavioral Therapy (CBT) might be effective in     reducing binge eating and improving surgical outcomes. The current study will examine whether     the addition of telephone-based CBT (Tele-CBT) to the usual standard of care is more     effective than the usual standard of care alone, and whether it is more effective when     delivered prior to or following bariatric surgery.   "
135700|NCT01508572|"     The purpose of this study is to determine the uptake, (semi-)quantification and localization     of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue,     surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical     specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using     fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW     is assessed. Another purpose is to assess the abilities of three different fluorescent signal     detection systems to detect the fluorescent signal pre- and intra-operatively.   "
135701|NCT01508559|"     The treatment of HIV and the tests performed for HIV care have changed over the last 20 years     but improvement of management of HIV-infected subjects is still warranted. The investigators     would like to collect and analyse clinical information obtained from subjects who are between     18 and 50 years of age. The investigators will look at routine clinic information such as     blood pressure, recent blood test results and clinical history. The investigators will then     assess cognitive (brain) function by talking and/or written tests. These tests will include     tests for memory, depression and anxiety.      All of those who are identified as having problems with their brain function in this way will     be offered onward referral for further assessment as appropriate. Those taking part will be     offered a follow up visit at 24-48 weeks after the first assessment to see if there are any     changes. This will allow us to understand how brain problems develop, get worse, or get     better over time. No genetic research will be done. Depression is a mental health condition     that can be characterized by negative feelings, a generally low mood, or problems with eating     and sleeping normally. Anxiety is also a mental health condition where a person can feel     general anxiousness or fear of specific situations, or, in more serious cases, can have panic     attacks. Impaired brain function is a condition of the nervous system or brain where the     brain does not function as well as it normally should, and can include symptoms such as     forgetfulness, doing everyday tasks more slowly or becoming disorientated to the time of day     or the place one is in.      For this study, the investigators will also collect data from medical records, including (and     if known)social and educational-related data, HIV infection-related data (e.g. date of     diagnosis, blood test results), relevant medical history (e.g. previous psychiatric     conditions) and medication used (e.g. date started, the drugs used).      The information the investigators will get from this study will be used to inform healthcare     providers (doctor, nurse, health advisor, psychologist) on whether it is necessary to     routinely assess HIV infected patients for the presence of anxiety/depression and impaired     brain function. The investigators will also get information on whether the treatments used     for HIV infection make a difference to how commonly these conditions occur in patients.   "
135702|NCT01508546|"     Rationale      Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant     treatment planning.      Purpose      Randomized phase III trial to compare the effectiveness of surgical therapy with or without     axillary dissection following conservative treatment in women with stage I breast cancer.      To determine the possibility to avoid axillary surgery in patients with early breast cancer,     finding an alternative method to define the need of adjuvant treatment without compromising     long-term disease control.   "
135703|NCT01508533|"     This study was designed to support site preparation and to conduct a disease burden study for     the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.   "
135716|NCT01508351|"     Hypotension is a recognized frequent complication of induction of anesthesia. The intent of     this research is to determine the incidence of hypotension in patients receiving anesthetic     induction with propofol. This investigation seeks to examine how normal clinical practice or     a real world understanding of the usual response to propofol affects hemodynamics without     isolating or standardizing other variables. The current research concerns hypotension in     normal clinical practice where variability exists. This project aims to gather information     and data in an attempt to form a foundation upon which each of the other variables affecting     blood pressure may be subsequently assessed.   "
135727|NCT01508195|"     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)     tablets of canagliflozin and metformin immediate release (IR) in comparison with the     individual components of the FDC tablets (canagliflozin and metformin IR).   "
135706|NCT01508494|"     The investigators would like to conduct a double blind placebo-controlled prospective study     to show the impact of a treatment combining a specific cognitive rehabilitation program and     acetylcholinesterase inhibitors on executive function of young patients 3 months after a     first symptomatic stroke. The secondary objectives will be to assess cognitive changes     performance (executive but also non trained functions such as memory) before and after     treatments and treatment effect on activity of daily living and on quality of life.      The main objective of this study is to show the impact of this combined treatment on brain     activation maps in VCI-ND patients in the post-acute phase (3 months) after a stroke.     Treatment effect will be assessed by functional MRI (fMRI) while patients will be performing     a specific executive task.      The investigators hypothesize that the specific rehabilitation associated with     acetylcholinestrase inhibitors treatment will focalize cerebral activation observed in fMRI,     improve executive functions specifically, improve non trained cognitive functions     (generalization effect).   "
135707|NCT01508481|"     Emerging evidence suggests that vitamin D [25-hydroxyvitamin D; 25(OH)D] may play a role in     the etiology of type 2 diabetes. Vitamin D levels are lower in those with type 2 diabetes and     impaired glucose tolerance (IGT) compared with those with normal glucose tolerance (NGT). In     addition, a few prospective studies have shown a significant inverse association of baseline     serum 25(OH)D with incident diabetes. To date, however, the exact mechanisms through which     vitamin D affects diabetes risk are not yet fully known, particularly whether vitamin D plays     a role in insulin resistance (IR) and/or b-cell dysfunction, the main pathophysiological     disorders underlying type 2 diabetes. So, the investigators plan to examine the prospective     associations of baseline vitamin D [25-hydroxyvitamin D; 25(OH)D] with insulin resistance     (IR), b-cell function, and glucose homeostasis in subjects at risk for type 2 diabetes.   "
135708|NCT01508468|"     The Membranous Nephropathy is one of the most common cause of Nephrotic Syndrome of adults.     In 2/3 of patients the cause of the disease is idiopathic. This can also be referred to as     idiopathic membranous nephropathy (IMN).The most of these patients are treated by non     immunosuppressive symptomatic treatment (NIST): antiproteinuric and antihypertensive blocking     the rennin-angiotensine system. However, the patients resistant to antiproteinuric treatment     risk to develop an end stage renal disease (ESRD).      Rituximab has been recently used in patients suffering of nephrotic syndrome related to IMN     in four international studies. Rituximab appears effective and safe in reducing proteinuria     in nearly 60% of patients.      The primary outcome of the investigators prospective randomized study is to determine whether     or not the Rituximab associated with NIST is more effective than non immunologic symptomatic     treatment alone in inducing long term remission of proteinuria.   "
135709|NCT01508455|"     The primary objective of this study is to characterize the safety, and efficacy of     Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a     continuous IV infusion in preterm subjects, ages ≥ 28 weeks through < 36 weeks gestational     age.   "
135710|NCT01508429|"     Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low     cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH),     especially in settings where injectable uterotonics are not yet available or feasible to use.      A double-blinded individual randomized controlled study of misoprostol versus placebo in home     deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit     pregnant women who are likely to deliver at home. All women enrolled in the study will     receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of     their baby (ies) and before delivery of the placenta.      Women who experience a PPH will be randomized to receive either: a) standard of care + 800     mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets     resembling misoprostol. In this setting, standard of care is referral.   "
135711|NCT01508416|"     Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event,     especially in newly diagnosed patients and during induction treatment with thalidomide in     combination with dexamethasone. This association was mainly heightened during the 3 first     months of chemotherapy.      Several coagulation abnormalities have been described. Laboratory tests measuring the overall     thrombophilic tendency might be useful to assess thrombosis risk.      The aim of this study is to compare thrombin generation by calibrated automated thrombogram     during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.   "
135712|NCT01508403|"     The purpose of this study is to make a cohort event monitoring to see whether and how     Shuxuetong injection in hospital results in adverse events or adverse drug reactions.   "
135713|NCT01508390|"     In this study, participants will have standard ADT and undergo standard XRT to the prostate     and at-risk lymph nodes by IMRT. The subsequent *boost* RT to the prostate alone will be     given using the CyberKnife, rather than using the standard IMRT. This study will also see how     CyberKnife affects the quality of the participant's life.   "
135714|NCT01508377|"     For several years now, a very successful treatment of posttraumatic stress disorders has been     offered in the Netherlands and in Germany. The contact between clients and therapists takes     place exclusively via Internet. The therapists follow a scientifically tested treatment     protocol, that defines fixed treatment elements that are adapted to the specific situation of     the client. The participants can write at home, in their familiar environment which makes it     easier to work on trauma related issues with their therapist. In the last years the treatment     was offered in Arabic as well indicating to be an effective treatment for Posttraumatic     Stress Disorder (PTSD) in Arabic-speaking countries.      The treatment lasts five weeks. During that time-frame, participants write several texts. The     participants decide when they want to write. Each time after having received two texts, the     therapists provide feedback and further instructions. The therapists are all trained     psychologists, who have received additional training in the interpretation of texts and for     the application of the treatment protocol.      The investigators hypothesize that both interventions will significantly improve clinical     symptoms of PTSD. Furthermore, the investigators expect improvements in secondary outcomes     such as anxiety, depression and quality of life.   "
135715|NCT01508364|"     This is an observational study which will investigate the use of Nexavar as first targeted     therapy in patients with advanced renal cell carcinoma.   "
135717|NCT01508338|"     The purpose of this study is to        -  determine the effects of 12 weeks of HMB free acid gel, ATP, and HMB free acid gel plus          ATP supplementation in trained individuals during a periodized training program on          skeletal muscle hypertrophy, body composition, strength, force, velocity, and peak power          during loaded and unloaded vertical jumps.      Additionally, the study will determine if either supplementation protocol prevents the     typical decay seen in performance following an overreaching cycle performed in the 9th and     10th weeks of the study.      Finally, the study will elucidate the mechanisms of action of supplementation on protein     breakdown by analyzing serum indices of muscle damage (CK, LDH) and anabolic status     (Testosterone:Cortisol ratio) as well as a urinary indicator of protein breakdown     (3-methylhistidine).      We hypothesize that under these conditions that the supplementation protocols will augment     skeletal muscle hypertrophy, strength, and power and that HMB will blunt increases in serum     indices of muscle damage, and urinary indices of protein breakdown.   "
135718|NCT01508325|"     This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority     and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in     subjects with mild to moderate primary hypertension.   "
135719|NCT01508312|"     The purpose of this study is determine if 2 cycles of SGN-35 can be used instead of ICE prior     to autologous stem cell transplant (ASCT) for relapsed and refractory HL. There are 2 steps     to treating patients with relapsed or refractory HL. The first step is to shrink the lymphoma     with chemotherapy. The chemotherapy regimen commonly used is called ICE. ICE is a combination     of chemotherapy drugs: ifosfamide, carboplatin, and etoposide. The second step of treatment     is to give high doses of chemotherapy and radiation therapy followed by infusion of stem     cells. This is called an ASCT. This study will focus on the first step of treatment for     relapsed and refractory HL.      ICE chemotherapy can cause many side effects. We believe that there are patients who can     receive less toxic treatments and still do well. We have learned from past studies that     [18F]FDG-PET scans (which we will call PET scans) can be used to predict who will do well     after ASCT. PET scans are tests used to measure the metabolic activity of the disease.     Patients without abnormal activity on their PET scan (negative PET scan) before ASCT are much     more likely to be cured than those with activity on their PET scan (positive PET scan).      In this study, instead of beginning with ICE chemotherapy, the patient will receive a new     drug called Brentuximab vedotin (SGN-35). SGN-35 is a type of drug called an antibody drug     conjugate. SGN-35 has 2 parts; a part that targets cancer cells (the antibody) and a cell     killing part (the chemotherapy). The antibody part of SGN-35 sticks to a target called CD30.     CD30 is an important molecule on some cancer cells (including Hodgkin lymphoma) and some     normal cells of the immune system. The cell killing part of SGN-35 is a chemotherapy called     monomethyl auristatin E (MMAE).      It can kill cells that the antibody part of SGN-35 sticks to.      Compared to ICE chemotherapy, SGN-has fewer side effects and does not require inpatient     admission for treatment. We aim to determine whether patients can avoid treatment with ICE     prior to ASCT. We will use the results of the PET scan to determine whether the patient needs     additional chemotherapy before ASCT. If the PET scan is negative, the patient will be     referred to ASCT and not receive ICE chemotherapy. If the PET scan is positive, the physician     will discuss further treatment options with the patient.   "
135720|NCT01508299|"     Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by     skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal     and reproduce false negative results (no allergy) in patients with history highly suggestive     of allergic reaction. The aim of this study is to compare the reproducibility of different     commercial extracts and raw food in patients with convincing history of acute allergic     symptoms related to food .   "
135721|NCT01508286|"     The purpose of this early access program is to provide telaprevir to patients with a specific     type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from     telaprevir-based therapy but who reside in countries in which telaprevir is not yet     commercially available and who are not eligible for enrollment into a clinical study of     telaprevir. The study also aims to collect information on the safety and adverse events with     telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically     used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients     in this study will also have a diagnosis of liver fibrosis and compensated liver disease.   "
135722|NCT01508273|"     The goal of this behavioral research study is to find out more about the health behaviors of     cancer survivors. Researchers want to understand the cultural, social, and environmental     factors related to physical activity and personal diet. Researchers also want to learn if     cancer survivors who take part in lifestyle interventions have better overall health and     quality of life than those who do not take part in these interventions.   "
135723|NCT01508260|"     The goal of this clinical research study is to learn about the safety and level of     effectiveness of aquapheresis compared to diuretic drugs. Diuretic drugs are designed to help     the kidneys to form more urine. They also remove fluids from patients with severe fluid     overload who have not responded to diuretics.      Aquapheresis is a procedure that removes excess fluid from the body. Blood containing too     much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and     passed through a special filter. The filter separates the excess salt and water from the     blood. The blood is returned to the patient and the fluid is collected in a bag to be     disposed. Aquapherisis may benefit patients by removing excess fluid and salt from the body.   "
135724|NCT01508247|"     Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of     epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a     small proportion of cases. There has been a significant increase in EV71 epidemic activity     throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen     associated with a severe from of brainstem encephalitis associated with pulmonary oedema and     high case-fatality rates.      The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a     clinically acceptable safety and good immunogenicity for healthy Chinese children and     infants. According to the immunogenicity and safety results, the 320U with adjuvant with     immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.   "
135725|NCT01508221|"     The purpose of this study is to determine whether the use of Trental and Vitamin E can help     reduce the incidence of radiation necrosis (a lesion that usually occurs at the original     tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis     when it occurs but the hope is that these drugs can be used to prevent radiation necrosis     from ever occurring.   "
135726|NCT01508208|"     The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and     evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of     urine for proteinuria is the gold standard for the diagnosis of the condition and allows the     physician to determine if an hypertensive disorder is related directly or not to the     gestation.      The problem is the time it takes and the technical difficulties related to the sample     collection. An alternative is the quantification of protein and creatinine in a random sample     of urine. We seek to evaluate if this method is as affective as the gold standard in the     diagnosis of proteinuria (>300 mg/d).   "
135728|NCT01508182|"     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)     tablets of canagliflozin and metformin immediate release (IR) in comparison with the     individual components of the FDC tablets (canagliflozin and metformin IR).   "
135729|NCT01508169|"     The objective of this study was to determine if foot orthoses are effective in improving     balance, pain and disability in elderly women with osteoporosis.   "
135730|NCT01508156|"     The purpose of the study is to test the safety and tolerability of different doses of IDX719     to find the best dose for future studies. The study will also assess the pharmacokinetics of     IDX719. No formal hypotheses will be tested.   "
135731|NCT01508143|"     The aim of this study is to compare two misoprostol regimen in pregnancy termination.   "
135732|NCT01508130|"     This prospective observational study will evaluate the efficacy and safety of two approved     pegylated interferon-based direct acting antiviral triple therapies in patients with chronic     hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin     plus either telaprevir or boceprivir in accordance with local standard of care and US     labeling will be followed for the duration of their treatment and for up to 24 weeks     post-treatment.   "
135733|NCT01508117|"     The purpose of this study is to determine whether the addition of an investigational     medication, axitinib, to radiation therapy will improve the outcome of treatment in patients,     above the age of 70.   "
135734|NCT01508104|"     The purpose of this clinical trial is to determine the effects good or bad of combining     BEZ235 along with Everolimus to determine if it is a safe treatment for patients with     advanced cancers of different types.   "
135735|NCT01508091|"     Calorie restriction is the only experimental manipulation that prolongs longevity in     experimental animals. The life prolonging effects of calorie restriction are related to a     lower incidence of tumors and less inflammation, but more importantly, a lower generation of     reactive oxygen species (ROS). This effect is related to the overexpression of two groups of     enzymes. One is a group of (NAD+)‐dependent deacetylases called sirtuins whose main actions     are to increase free fatty acid flow from adipose tissue, improve insulin secretion and     promote mitochondrial biogenesis in muscle. The other group corresponds to uncoupling     proteins (UCP), specially UCP 3 that reduces the mitochondrial production of ROS. On the     other hand, an effect of calorie restriction that is always reported, is a decrease in     resting energy expenditure. A reduction in the activity of UCP1 in brown adipose tissue could     be a mechanisms to explain this effect. However sirtuins apparently increase the expression     of UCP1.Recently PET CT scans have emerged as a non invasive methodology to recognize brown     adipose tissue activity and indirectly, UCP1 activity. Also measurement of telomere length in     peripheral blood mononuclear cells has consolidated as a good marker of aging. Two possible     models of calorie restriction can be studied in humans. One is a retrospective model in which     adults are separated in those that have maintained a stable weight during adulthood in a     manner analogous to the weight clamp model of calorie restriction in non human primates. This     model is only reliable if there are objective records of the weight that the studied subjects     had 20 or more years ago. In the retrospective part of this project the investigators propose     to study adults whose weight was recorded previously. The investigators pretend to compare     telomere length and expression of SIRT1 and 6 in PBMC, plasma 8 isoprostanes and carotid     intima media thickness between weight maintainers and weight gainers. The investigators     hypothesis is that weight maintainers will have a better aging profile than weight gainers.     In the prospective part of the project the investigators will study a human model of calorie     restriction prescribing a 25% reduction in calorie intake during 3 months and comparing     groups according to weight loss. At baseline and the end of the study period, UCP3 and SIRT1     expression in muscle biopsies, SIRT1 and 6 expression in PBMC and brown adipose activity,     assessed by 18fluorodeoxyglucose uptake using PET/CT will measured. The investigators     hypothesis is that individuals subjected to calorie restriction will experience an increase     in the expression of UCP3, SIRT1 and SIRT6 and a reduction in brown adipose tissue activity.     Simultaneously, these subjects will experience a reduction in oxidative stress markers in     muscle and plasma.   "
135736|NCT01508078|"     This study is designed to characterize subjects in terms of the nature and severity of their     asthma and in terms of conditions that may alter the clinical expression of asthma. Some     features will be obtained in all subjects. These include a medical history and baseline lung     function tests. This characterization forms the basis for our database that facilitates     research protocols.   "
135737|NCT01508065|"     Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic     goal that is difficult to achieve with current blood glucose monitoring technology. Home     blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of     severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy     to operate glucose monitoring in DM patients for strict glycemic control cannot be     overemphasized.      The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an     acceptable mean relative error when compared to acceptable invasive blood glucose     measurements.      The primary objectives of the trial are to determine:        1. The safety of the Glucometer GM-205 in evaluating blood glucose levels        2. The accuracy of the Glucometer GM-205 in evaluating blood glucose levels   "
135738|NCT01508052|"     We hypothesized that sequential compression device (SCD) compression system might induce more     decreases on core temperature by increasing lower extremity blood flow. And, this study     investigated the effects of SCD compression system on body temperature in patients during     total intravenous anesthesia (TIVA) with propofol and remifentanil.   "
135739|NCT01508039|"     The purpose of the study is:        -  To investigate whether chitin can effect healthy adults, the nasal mucosa in a direction          that will enhance the immune response to infection        -  To investigate whether chitin influence of the nasal mucosa is well tolerated, and that          there is no inflammation, as it seen with exposure to endotoxin.   "
135740|NCT01508026|"     To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan     compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.   "
135741|NCT01508013|"     The purpose of this study is to determine whether a skin cancer prevention website is     effective at reduce female teenagers' desire to use indoor tanning and ultimately their use     of indoor tanning over an 18 month period.   "
135742|NCT01508000|"     Patients presenting with multiple innumerable liver metastases will probably never come to     resection, however, for all others, including patients with numerous multiple metastases or     large metastases,resection should be considered after limited chemotherapy.      There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin.     FOLFOX was used in the previous EORTC study and is again recommended.      The addition of targeted agents to standard chemotherapy in the perioperative strategy for     mCRC might increase the ORR and R0 resectability, without significant increase in toxicity,     therefore translating to a better outcome.      It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase     II study.      Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery     Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery   "
135970|NCT01505023|"     The objective of this study was to test the efficacy of a partial meal replacement added with     vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in     obese Mexican women   "
135743|NCT01507987|"     The objectives of the study are:        1. To determine the prevalence of externalized conductors at enrollment in Riata®, Riata®          ST Silicone, QuickSite®/QuickFlex® and Durata® leads        2. To determine the prevalence of other visual lead anomalies (fracture, subclavian crush,          kink, broken filars on a shocking coil and other irregularities) by each subcategory at          enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads        3. To determine the prevalence of electrical dysfunction at enrollment in Riata®, Riata® ST          Silicone, QuickSite®/QuickFlex® and Durata® leads        4. To determine the incidence of externalized conductors after enrollment in Riata®, Riata®          ST Silicone, QuickSite®/QuickFlex® and Durata® leads        5. To determine the incidence of other visual lead anomalies by each subcategory after          enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads        6. To determine the incidence of electrical dysfunction after enrollment in Riata®, Riata®          ST Silicone, QuickSite®/QuickFlex® and Durata® leads.        7. To evaluate the 30-day adverse event rate associated with lead revision procedures          (include lead extractions or abandonments with or without lead replacement) in Riata®,          Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads        8. To determine the prevalence of other insulation anomalies in returned leads for          Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads. Other          insulation anomalies include any of the following:             -  Internal abrasion short under RV shock coil             -  Internal abrasion short under SVC shock coil             -  Exposed conductors defined as a breach of the outer insulation             -  Breach of the internal silicone lumen tubing, but the conductor cable is contained               within the lead body diameter.   "
135744|NCT01507974|"     Urinary tract infection is the most common bacterial infection during pregnancy. Asymptomatic     bacteriuria is the most common infection, in up to 8% of the population. Symptomatic     infection may cause cystitis or cause pyelonephritis.      Among pregnant women with recurrent bacteriuria, preventive antibiotic treatment has been     found to be efficacious in reducing the bacteriuria rate and the complications.      the changes of the urinary tract which appear during pregnancy usually resolve up to 3 months     post-partum.      The purpose of this study is to examine the efficacy of preventive antibiotic treatment     during the puerperium.   "
135745|NCT01507961|"     Hypothesis: there is a positive correlation between tissue thickness measured from CBCT and     clinical measurements.   "
135746|NCT01507948|"     The investigators are seeking people who have been exposed to a traumatic event in the past     and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may     feel significant distress when reminded of a traumatic event or feel depressed, anxious or     jumpy.      As a part of this study, participants will receive brain MRIs and office assessments before     and after psychotherapy. The investigators provide the gold-standard psychotherapy for PTSD,     Prolonged Exposure, free of charge; additionally participants are compensated for their     time during assessment procedures. This study is exploring the brain circuitry involved in     improvement in response to psychotherapy.   "
135747|NCT01507935|"     This study is initiated to investigate the effect of infant formulas with added specific     prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.   "
135748|NCT01507922|"     It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine     maleate in the efficacy and safety.      Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and     safety.   "
135749|NCT01507909|"     Exposure to alcohol related cues, such as the sight of alcoholic drinks, may induce craving     for alcohol in drinkers. In this study, the effects of exposure to (1) the pictures of     alcoholic drinks and (2) the imagining of a scene related to drinking on activity in the     frontal region of the brain in heavy social drinkers will be determined. This study is being     conducted to develop the methods needed to allow for the detection of cue-induced changes in     drinkers using the EEG. The objective of this pilot study is to establish procedures for     detecting alcohol-related cue-elicited changes in EEG activity in heavy drinkers.   "
135750|NCT01507896|"     The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in     subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B     undergoing major or minor elective or emergency surgical, dental or other invasive     procedures.   "
135751|NCT01507883|"     Current human IVF technology employs two strategies with respective culture media for embryo     development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature'     (utilizes sequential media). To our knowledge, there is not any sibling oocyte study to     evaluate potential advantages/disadvantages of these strategies on one another.   "
135752|NCT01507870|"     Incisional hernia is one ot the most frequently seen long term complications in abdominal     surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for     incisional hernia after midline incision remains about 5-20 %. One major risk factor for     incisional hernia after a median laparotomy is obesity.      The closure technique of midline incisions has remained unchanged since many decades and     primarily consists of suturing the linea alba. Interest in prevention of incisional hernias     with the aid of synthetic mesh is growing and only one large randomized trial is active     recruiting patients in Germany, Netherlands and Belgium (Prima Trial).      Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after     midline incision with an incidence of 22% after 12 months. This high risk group of patients     may benefit from prevention.      Some small studies have been performed to evaluate the usefulness and safety of primary     laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk     for incisional hernias and a low infection rate, even when used in contaminated wounds such     as colostomy surgery.      The goal of this study is to evaluate the effectiveness of incisional hernia prevention after     elective median laparotomy in patients with a BMI of more than 27. A randomized controlled     trial will be performed comparing the commonly used technique of running suture to close with     the aid of a prosthetic onlay mesh. The primary outcome measure will be incisional hernia     occurrence. Secondary outcome measures will be complications, surgical site infections,     post-operative pain and quality of life.   "
135753|NCT01507857|"     The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71     Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy     infants volunteers aged from 6 to 35months old.   "
147651|NCT01351597|"     The purpose of this study is to evaluate the overall response rate, toxicity, progression     free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent     or metastatic breast cancer.   "
135754|NCT01507844|"     Chronic obstructive pulmonary disease is a disease characterized by small airways     inflammation and obstruction. The small airways disease produces hyperinflation (air     trapping), which increases with exercise. Continuous positive airways pressure may reduce     small airways obstruction and therefore air trapping. Pulmonary function tests including lung     volumes at rest and and after exercise will be measured. In addition, exercise endurance time     before treatment and after treatment will be measured.   "
135971|NCT01505010|"     INSPiRED is a multicenter parallel-group trial comparing usual medical treatment (control     group) or usual medical treatment plus renal denervation (intervention). In both groups     adherence will be monitored both before randomization and during 36 months of follow-up.   "
135755|NCT01507831|"     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9     (proprotein convertase subtilisin/kexin type 9).      Primary Objective of the study:      To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk     participants with hypercholesterolemia not adequately controlled with their current lipid     modifying therapy (LMT).      Secondary Objectives:        -  To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C)          levels after 24 weeks of treatment in comparison with placebo.        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time          points.        -  To evaluate the effects of alirocumab on other lipid parameters.   "
135756|NCT01507818|"     To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on     narcotic use, pain, and health-related quality of life following shoulder arthroscopic     rotator cuff surgery comparing: Active treatment versus placebo (Sham).   "
135757|NCT01507805|"     The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning     for five days before operation can improve the outcomes of patients with coronary heart     disease undergoing geriatric non-cardiac surgery.   "
135758|NCT01507792|"     Chronic cough is more frequent and severe in women than in men. Women often have decreased     iron stores, due to menses and pregnancies. Aim of the study: to investigate if iron     deficiency has a role in chronic cough by favouring airway hypersensitivity to inhaled     irritants.   "
135759|NCT01507779|"     The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent     A/H1N1 influenza vaccine (IVACFLU)-—each dose with an HA content of 15 mcg from     A/California/07/2009 (H1N1)-like virus-—will be safe and immunogenic in healthy adults.   "
135760|NCT01507766|"     As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN),     especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and     stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents     bacterial and endotoxin translocation and thereby theoretically reduces the incidence of     infections. Therefore, EEN has the ability to reduce the infectious complications, length of     hospital stay and mortality of patients with SAP.      However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH)     in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic     organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the     blood flow of gut, and then results in the development of intestinal ischemia and edema. The     hypoxia and hypoperfusion of intestine leads to the increase of permeability of the     intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could     result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific     IAP values on the tolerance of EEN have not been reported.      Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due     to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause     expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to     date reporting the association between EEN and IAH in patients with SAP. Therefore, the     present study aimed to investigate the influence of specific IAP on the tolerance of early     enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts     of EEN on the disease severity and clinical outcome of SAP were also researched.   "
135761|NCT01507753|"     Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be     a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly     impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Available     evidence-based pharmacotherapy guidelines are for BP1; efficacious medications are,     unfortunately, associated with significant risk for adverse events (Kowatch et al, 2005;     2009). Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a     beneficial effect on mood, which might provide either a primary or adjunctive treatment with     a more favorable risk:benefit ratio for children suffering from BP-NOS than currently     available pharmacologic interventions. Psychoeducational psychotherapy (PEP) also has shown     promise in treating bipolar spectrum disorders in children aged 8-12 (Fristad, 2006; Fristad,     Verducci, Walters, & Young, 2009); its efficacy in treating BP-NOS specifically has not been     determined.      The current study compares Ω3, PEP, and their combination to a placebo supplement and active     monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP,     PEP, and placebo, all with active monitoring). Primary goals are to determine: 1) feasibility     of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial;     and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and     depressive symptoms. Secondary goals are to explore response curves over time, mediators and     moderators, treatment response across a broad array of outcome variables, adherence to     treatment, impact on physiologic parameters often worsened by mood stabilizing medications,     and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of     results to a parallel study of children with depression with identical design will maximize     knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence     about whether a larger trial is feasible and justified.   "
135762|NCT01507740|"     Tumour angiogenesis has been identified to play a critical role in tumour growth and this     knowledge has led to the identification of new targets for cancer therapy. Multiple     angiogenic factors are involved in the regulation of angiogenesis, among them VEGF (vascular     endothelial growth factor) and its receptor are of crucial relevance. The inhibition of VEGF     signaling by monoclonal antibodies or small molecules (kinase inhibitors) has already been     successfully established for the treatment of different cancer entities and multiple new     drugs are being tested in clinical trials. The ever-expanding list of antiangiogenic agents     being available in the near future will raise the questions when to use which agent and in     which sequence. As a consequence biomarkers are going to be indispensible tools for choosing     the most effective drugs and to predict dosing and resistance.      The present project is based on an academic clinical trial in which patients suffering from     different cancer types (colorectal cancer, non-small cell lung cancer, renal cell cancer and     hepatocellular cancer) treated routinely with antiangiogenic agents will be included.     Consecutive serum and blood probes will be taken and will be examined and correlated with     functional imaging and the clinical course. The following parameters have been selected:     soluble markers in the plasma (VEGF, bFGF, ICAM, sVGFR-2 IL-8, SDF1 and Dickkopf 3) and     cellular parameters like circulating endothelial cells (CEC) and circulating endothelial     progenitor cells (CEPs).      In conclusion, the present project is screening for potential biomarkers and biomarker     combinations relevant for antiangiogenic drugs in different tumour types. The predictive     value of such profiles should then be evaluated in larger cohorts. In the future such     profiles could possibly help clinicians to use these agents more effectively and therefore     also more economically.   "
136457|NCT01498640|"     The objectives of this study are to assess the safety and efficacy of AA4500 in the     retreatment of recurrent contractures in joints that were effectively treated with AA4500 in     a previous Auxilium-sponsored Phase 3 study.   "
135763|NCT01507727|"     This drug has been developed to treat Hyponatremia. The primary purpose of this study is to     verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15,     30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to     Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic     Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.   "
135764|NCT01507714|"     Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress     incontinence is a health problem with social, economic and psychological consequences. The     appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known     phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which     has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence     post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress     incontinence.      The aim of this study is to examine the efficacy of transobturator tension free vaginal tape     (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.   "
135765|NCT01507701|"     The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and     safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the     investigators wanted to assess appropriate dosage in relation to a) plasma concentration     levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure     responses when rising up), and c) reports of possible adverse effects.      A possible beneficial effect of clonidine in adolescent CFS will be investigated in     NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.   "
135766|NCT01507688|"     The experience of a stroke event may result in a disruption to the survivor's daily life.     Patients with stroke have reported fears of permanent disability and major concerns over     their ability to recover and be productive and engaged with family, friends and coworkers. To     enhance recovery from stroke, the investigators designed a stroke self-management program and     have pilot tested the program among Veterans recovering from stroke/TIA. The proposed study     is a three-site, randomized controlled trial designed to test the efficacy of a stroke     self-management program. The intervention program includes 6 bi-weekly sessions over months     1-3 followed by monthly telephone calls as the investigators administered in the     investigators' pilot study during months 4-6 for a total length of program duration of 6     months. The investigators have added 3 monthly group support sessions during months 4-6 for     additional peer support. Thus, participants will receive bi-monthly support during months     4-6. The three intervention sites include the Jesse Brown VAMC in Chicago, the Roudebush VAMC     in Indianapolis, and the IU Health Methodist Hospital in Indianapolis, Indiana. The three     hospitals represent facilities with a small, moderate, and large volume of acute stroke care,     respectively. Additionally, Methodist Hospital includes a greater proportion of women which     enables us to study the patterns and preferences of women with stroke/TIA and tailor the     investigators' future programs to prepare for the increasing female Veteran population.   "
135767|NCT01507675|"     The primary purpose of the current study is to rigorously test the psychometric properties of     the INQ-12 and ACSS (Van Orden et al., 2008) in Veterans, something which has not been done     to date. Factor structure, internal consistency, convergent and discriminant validity will     all be assessed. Secondary goals are to determine if burdensomeness, failed belongingness,     and acquired capability are distinct versus overlapping constructs and whether or not values     mediate the relationship between reasons for living and suicide risk. Lastly, the inclusion     of the Beck Scale for Suicidal Ideation (BSS) allows us to analyze participants' responses to     explore whether or not participants can be grouped into those who want to die by suicide     because they want to escape their problems and those who want to die to influence other     people.   "
135768|NCT01507662|"     There is growing evidence that patients undergoing bone mineral density testing (BMD) often     do not take important steps to improve their bone health. The investigators will conduct a     randomized-controlled trial to evaluate the impact of a novel and practical patient     activation intervention (mailing patients their bone density test results) on the quality of     bone-related healthcare and the cost-effectiveness of BMD testing. Equally important, the     investigators intervention could easily be modified to include other patient populations and     chronic diseases.   "
135769|NCT01507649|"     Purpose: To evaluate the effectiveness of a telephone-based intervention using     cognitive-behavioral approach in preventing postnatal depression and improving quality of     life in first-time Chinese mothers.      Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will have     a lower level of depressive symptoms (primary outcome) and a higher level of quality of life     at 6 weeks and 6 months postpartum than those who receive the usual postpartum care.      Design and subjects: Randomized controlled trial is used. A sample of postpartum women with     high risk of postnatal depression (EPDS > 9, n = 498) will be randomly assigned to either the     experimental (n = 249) or the control groups (n = 249). The experimental group receives the     intervention and the control group receives usual postpartum care.      Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12).      Interventions: The intervention is based on the cognitive-behavioral approach. It consists of     five, 30-minutes sessions delivered weekly from postpartum week one to week five via     telephone.      Main outcome measures and analysis: Outcomes on postnatal depression and quality of life will     be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A     repeated-measures multivariate analysis of variance will be used to compare differences     between two groups.   "
135781|NCT01507493|"     This study was conducted to explore whether the non-synonymous single-nucleotide     polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative     pain intensity in the general population undergoing upper abdominal surgery. Methods:     Patients receiving elective upper abdominal surgery under general anesthesia were recruited     into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators     measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO).     The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled     analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press     frequency and drug consumption were recorded.   "
136192|NCT01502124|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin®     cartridges (liquid somatropin) in children with growth hormone deficiency.   "
135968|NCT01505049|"     Vaccines for human papillomavirus (HPV) have been available in the United States since 2006.     Early studies have shown a high rate of effectiveness of these vaccines, however it is not     known how long this protection will last. The IMAP study will look at various parts of the     immune system and potential markers for long lived immune responses to this vaccine.   "
135770|NCT01507636|"     Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb     movements, which cannot be explained by elementary motor and sensory deficits or cognitive     problems. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous     system and the leading cause of disability in young adults. Apraxia and impaired manual     dexterity are common problems in patients with MS leading to impaired activities of daily     living. However, a specific training program to improve apraxia as well as manual dexterity     in MS is lacking.      In this study, the investigators want to evaluate the impact of a targeted occupational     therapy program on apraxia and manual dexterity in patients with MS that have dexterity     problems.      Patients routinely seen in the investigators MS consulting hour, fulfilling all inclusion and     exclusion criteria and willing to participate in the study will be evaluated for Apraxia and     manual dexterity. In case of Apraxia and/or impaired manual dexterity, patients will be     randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental     group) or general physical exercises (control group) for 4 weeks.      At study entry and study end after 4 weeks, apraxia and manual dexterity will be tested in     all patients.   "
135771|NCT01507623|"     Propofol is widely used by anaesthesiologists for deep sedation and general anaesthesia.     During recent years nurses trained in the use of low dose Propofol sedation (NAPS) during     endoscopy have been introduced. The method has been implemented at the endoscopic unit at     Gentofte hospital since 2008(1). Propofol has a respiratory depressive effect which may     result in depressed oxygen saturation in the blood (hypoxia). Due to a short acting half life     this is prevented in the majority of cases. However, in spite of this, hypoxia is experienced     in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished     data). It is well known that hypoxia constitutes a late expression of reduced oxygen tension     in peripheral tissues. Whether the addition of capnography to standard monitoring during NAPS     may be of benefit is widely unknown. The aim of this study is to examine whether the     additional use of capnography to standard monitoring during endoscopy may improve patient     safety in patients undergoing low dose Propofol sedation by reducing the number, duration and     level of hypoxic events. The trial is a randomized clinical prospective case-control study.   "
135772|NCT01507610|"     The purpose of this study is:        -  To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg          OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX®          (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in          healthy subjects.        -  To estimate the relative bioavailability of single-dose intranasal administration of 20          mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX®          (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan)          Subcutaneous Injection, in healthy subjects.   "
135773|NCT01507597|"     Diabetes(both types) are recognized by high levels of glucagon in the circulation.      Glucagon is known to increase blood glucose, and might therefore contribute to the respective     diseases. Under some circumstances the gut hormone GLP-1 inhibits the glucagon secretion.      The investigators aim to identify the impact of GLP-1 on the glucagon secretion, at     increasing blood glucose levels in healthy subjects, in patients with type 2 diabetes, and in     patients with type 1 diabetes.      The investigators think that the effect of GLP-1 on the glucagon secretion might be dependent     of blood glucose levels.   "
135774|NCT01507584|"     This clinical trial is designed to investigate the efficacy profile of the SENSIMED     Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension,     done three times at monthly intervals under different therapeutic regimen. This trial will     also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular pressure     (IOP) after the water drinking test (WDT) will be investigated.   "
135775|NCT01507571|"     The purpose of the study is to investigate whether Danish patients with incurable cancer have     a need of, interest in and benefit from Dignity Therapy.   "
135776|NCT01507558|"     The purpose of this study is to test if dexamethasone, an anti-inflammatory medication     approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue     around the blood vessel wall at the time of an angioplasty or atherectomy.   "
135777|NCT01507545|"     The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe     in the treatment of metastatic, colorectal cancer.   "
135778|NCT01507532|"     Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of     Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous     ceftazidime pharmacokinetics will be performed in patients undergoing intermittent     hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in     high flux hemodialysis.   "
135779|NCT01507519|"     1.) Indigenously developed and designed BioMimeTM is a        -  predictably safe & efficacious 3rd generation drug eluting stent (DES)        -  with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low          strut thickness Co-Cr stent,        -  highly documented drug Sirolimus &        -  a biocompatible, biodegradable polymer   "
135780|NCT01507506|"     This is a multi-institutional phase III clinical study of interventional type. The trial will     include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years     of follow up.      Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or     surgical specimen) and who meet all eligibility criteria will be randomized in one     chemoradiotherapy arm :        -  Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide        -  Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy          guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring          will be regular and standardized. The main objective of this study is to improve overall          survival of patients treated in experimental group (with simultaneous integrated boost).   "
135797|NCT01507272|"     This trial is conducted in Europe. The aim of this trial is to assess the safety and     tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170     (liraglutide).   "
135914|NCT01505751|"     G9a protein was approved to be highly associated with recurrence of breast cancer, gastric     cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this     study was to clarify the association and G9a protein and cervical cancer by analyzing the     immunohistochemical staining of G9a protein to the histopathologic specimen of cervical     cancer and clinical data.   "
135782|NCT01507480|"     Antiangiogenic drugs, such as bevacizumab, are a new treatment strategy in Hereditary     Hemorrhagic Telangiectasia (HHT). Its systemic administration in patients with HHT improves     liver damage-related symptoms and epistaxis (cases reported and on-going     study-ClinicalTrials.gov Identifier #NCT00843440-). To limit the systemic adverse effects of     bevacizumab and to ease administration, a local administration seems suitable.      A clinical case recently showed the benefits of bevacizumab nasal spray in these patients.     Its results were confirmed in a characterization study on bevacizumab transport through     porcine nasal mucosa (in press).      It seems necessary to assess the tolerance and efficacy of bevacizumab nasal spray in humans     for the treatment of epistaxis in HHT with a prospective phase 1 study.      The primary objective of the study is to evaluate the tolerance of increasing doses of     bevacizumab administered as a nasal spray in patients with HHT-related epistaxis.      This phase-1, randomized, double-blind, placebo-controlled, monocentric study is to be     carried out sequentially (dose escalation) on 5 groups of 8 patients. Each group is made up     of 6 verum and 2 placebos.   "
135783|NCT01507467|"     The purpose of this study is to test the hypothesis that radiotherapy of head and neck     carcinoma can be improved by hypoxic modification of radiotherapy using nimorazole as a     hypoxic radiosensitizer in association with accelerated fractionation, in an unselected     patient population in a global environment.   "
135784|NCT01507454|"     This study is conducted in Europe. The aim of this study is to investigate the self-reported     impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic     vaginitis due to oestrogen deficiency.   "
135785|NCT01507441|"     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in     the laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research trial studies DNA samples from patients with Down syndrome and acute     myeloid leukemia treated on COG-AAML0431 clinical trial.   "
135786|NCT01507428|"     This randomized phase II trial studies how well positron emission tomography (PET)/computed     tomography (CT)-guided radiation therapy works compared to standard radiation therapy in     treating patients with stage III non-small cell lung cancer. Radiation therapy uses     high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans,     to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor     and cause less damage to healthy tissue.   "
135787|NCT01507415|"     This study aims to evaluate simple tests of physical function in hospitalised patients with     chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future     hospital readmission. The Short Physical Performance Battery (SPPB) is a simple test of     standing balance, usual walking speed (4-metre gait speed) and ability to stand from a chair,     which reflects global physical functioning and frailty.      We hypothesise that the SPPB or 4-metre gait speed can predict future hospital readmissions.   "
135788|NCT01507402|"     This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess     the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in     healthy volunteers.   "
135789|NCT01507389|"     This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in     subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects     with normal hepatic function.   "
135790|NCT01507376|"     This study is a prospective randomized clinical trial to compare the efficacy of the urinary     and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.   "
135791|NCT01507363|"     Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The     investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.   "
135792|NCT01507350|"     Increasing risk of impaired renal function as a result of obesity is well known. Early data     has postulated that weight loss might improve kidney function, but the evidence is rather     limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight     loss. Cystatin C, GFR measurement using Cockcroft-Gault (CCG) and Modification of Diet in     Renal Disease (MDRD) equations, have all yield conflicting results after weight loss surgery.      The study aim to assess:        1. use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in          renal function before and after weight loss surgery.        2. the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss          surgery        3. the differences in alterations in renal function dependent on the surgical procedures(          gastric bypass, gastric band, sleeve gastrectomy).        4. the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.   "
135793|NCT01507337|"     This trial is conducted in Europe. The aim of this trial is to compare the exposure of     liraglutide in young versus elderly healthy subjects.   "
135794|NCT01507311|"     This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC     90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard     meal in subjects with type 2 diabetes.   "
135795|NCT01507298|"     This is an observational study, which aims to compare the outcomes of ambulatory     gastrointestinal investigations with physical activity using accelerometry. An ambulatory     study refers to one in which the patient is monitored freely, often outside of the hospital     environment. For this the investigators will use a lightweight (7.4g) tri-axial accelerometer     worn behind the ear.      For capsule endoscopy, the investigators are interested in how physical activity affects the     speed of capsule transit through the GI tract. Capsule endoscopy involves a patient     swallowing a pill which contains a camera, in order to image the parts of the bowel that a     conventional endoscope cannot reach. A rapid transit may result in insufficient mucosal     visualisation, which would reduce the sensitivity of the investigation.      For oesophageal pH monitoring, it is essential that the patient behaves as they would     normally to produce measurements that represent a standard day. Using accelerometry, the     investigators can compare the amount, and nature, of physical activity taken throughout the     investigation to that of the preceding day, or week. In addition, further analysis of motion     data captured will allow us to correlate specific activities and body orientation with pH     readings to get a better insight into the pathophysiology of a patient's condition.      The studies will be conducted over 6-9 months in Imperial College Trust's medical outpatient     service. All patients undergoing capsule endoscopy or ambulatory oesophageal monitoring will     be asked to consider participating. Patients will receive the eAR sensor up to 2 days before     their investigation, and will be asked to wear it until the end of their investigation (not     whilst sleeping). Capsule endoscopy normally takes less than 12 hours, and pH monitoring     takes between 24 and 48 hours. Participation makes no difference to the standard or type of     care that they will receive, the sensor data is additional.      Hypothesis 1 There is no change in the amount or nature of physical activity taken by     patients during ambulatory oesophageal pH monitoring or capsule endoscopy.      Hypothesis 2 There is no correlation between physical activity levels and speed of     gastrointestinal transit.   "
135796|NCT01507285|"     This trial is conducted in Europe. The aim of this trial is to assess the safety and     tolerability (maximum tolerated dose) after single and multiple doses of NNC 90-1170     (liraglutide) in healthy volunteers and in subjects with type 2 diabetes.   "
135798|NCT01507259|"     The popularity of chocolate can largely be attributed to its mood elevating properties,     research shows that it contains antioxidants that also provide physical health benefits. Dark     chocolate, in particular, contains high levels of an antioxidant called epicatechin, which is     known to cause changes in blood vessels by relaxing them and increasing blood flow.      Little is know about the immediate effects of chocolate consumption, or the differences     between milk and dark chocolate with regards to these effects. The project will investigate     the effect of a single bar of dark or milk chocolate upon blood flow to the brain, using     simple ultrasound tests.   "
135799|NCT01507246|"     This study is designed to compare the standard of care against EXPAREL(R) to determine if     total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total     hospitalization costs.   "
135800|NCT01507233|"     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome     extended-release injectable suspension) to determine if total opioid consumption is reduced     when using EXPAREL, therefore possibly reducing total hospitalization costs.   "
135801|NCT01507220|"     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome     extended-release injectable suspension) to determine if total opioid consumption is reduced     when using EXPAREL therefore possibly reducing total hospitalization costs.   "
135802|NCT01507207|"     Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging     science. The largest published series of pediatric patients with type I laryngeal clefts     shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of     treatment. A comparison of quality of life outcomes before and after injection laryngoplasty     has not been carried out. The investigators hypothesize that injection laryngoplasty     significantly improves symptoms and quality of life related to dysphagia in a pediatric     population with laryngeal clefts.   "
135803|NCT01507194|"     This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV     ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure     of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.   "
135804|NCT01507181|"     This study will examine the effects of Intravenous (IV) ketamine both in an outpatient     population and with subjects on the inpatient unit with suicidal ideation (SI).   "
135805|NCT01507168|"     This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety     of RO5137382 (GC33) in previously treated patients with unresectable advanced or metastatic     hepatocellular carcinoma. Patients will be stratified according to the level of GPC-3     expression in tumors and randomized to receive either RO5137382 (1600 mg intravenously) or     placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study     treatment is until disease progression or unacceptable toxicity occurs.   "
135806|NCT01507155|"     Genomind has developed and introduced a battery of genetic tests, the Genecept Assay, which     clinicians can administer to patients using a simple saliva sample technique. The present     study proposes to enroll 1. Subjects (patients who have consented to using the Genecept     Assay) and 2. Clinician study participants (clinicians who have ordered the Assay on behalf     of their patients). This study will involve the collection of responses from both Subjects     and clinician study participants with the intention of correlating this information to     Subject genetic data.   "
135807|NCT01507142|"     This study has been designed to evaluate a new oral test for therapeutic monitoring of     HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART). The test     will measure saliva-based Stress Response Profiling(SRP) biomarkers using laboratory assays.     Results of the test will show if HIV/AIDS patients successfully responded to cART.     Preliminary studies showed that SRP biomarkers were strongly increased in cART-unresponsive     AIDS patients. However, the diagnostic accuracy of the oral test, patients will be recruited     to donate saliva: AIDS patients responsive or unresponsive to cART, and controls (acute or     early HIV patients, and HIV-negative patients with hepatitis).      The saliva samples will be used to measure SRP biomarker concentrations. Results will show     whether the biomarker measurements provide accurate and specific diagnostics for ART     response.   "
135808|NCT01507129|"     Low levels of dehydration (the loss of body water corresponding to 2% of the body weight),     deteriorate physical and cognitive performance and may also be linked to a number of chronic     diseases. The standard test used for the assessment of hydration status is plasma osmolality.     This blood test is invasive, requires time and laboratory equipment and is not accurate for     isotonic dehydration. The goal of this project is to determine whether a new molecular     technology, saliva-based Stress Response Profiling (SRP) biomarkers, could be used for     non-invasive diagnostics of dehydration.   "
135809|NCT01507116|"     The study is conducted in Africa, Asia, Europe, Japan, North America and South America.      The multinational surveys will explore the experiences and unmet needs of people with     diabetes, as well as those of family members of people with diabetes, and of healthcare     professionals treating people with diabetes.   "
135810|NCT01507103|"     The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25)     administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects     with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy.      Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune     rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in     all colorectal cancers and since the adaptive immune system plays a role in the prognosis of     rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might     boost the tumor-specific immune response and increase the number of tumor-infiltrating     lymphocytes (TILs).   "
135811|NCT01507090|"     In 'real-world' health care settings there exist a number of circumstances where the weight     of a child is desirable or even necessary but unavailable. Numerous weight estimation     strategies have been described but each has limitations. Investigators at Children's Mercy     Hospitals and Clinics recently developed a weight estimation method and tool that addresses     the limitations of previously published methods. This study is intended to validate the     device in a population of children 2 months to 16 years of age.   "
135812|NCT01507077|"     The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety,     and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).   "
135969|NCT01505036|"     SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with     diabetes.   "
135814|NCT01507051|"     The study objective is to investigate the pharmacodynamics (effects of a drug product) when     switching the treatment from warfarin to rivaroxaban.      84 young, healthy subjects will participate; they will be treated following a randomized,     parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind     (Treatments A and B) design.      The first two groups (A, B) will receive warfarin for approximately one week to adjust their     blood coagulation values to a specific level, i.e. to maintain an INR (international     normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant     treatment.      The first group (A) will receive rivaroxaban for four days, the second group (B) will take     placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize     the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin     but will receive rivaroxaban for four days.   "
135815|NCT01507038|"     The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617     after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to     investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of     treatment period and 8weeks of follow-up period without treatment.   "
135816|NCT01507025|"     The purpose of this study is to investigate the possible effect of hinge location on corneal     sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).   "
135817|NCT01507012|"     Polyphenols, compounds found at high levels in berry fruit, have been shown to have health     promoting benefits through various mechanisms both in vivo and in vitro. These benefits     include antioxidant activity, anti-inflammatory properties, and monoamine oxidase (MAO)     inhibition. This study aims to expand on the extremely promising animal data in the     literature, and our own pilot study results, to investigate whether drinks containing berry     fruit can improve cognitive performance and mood in healthy human participants.      Our central hypothesis is that fruit extracts can reduce the breakdown of neurotransmitters     such as dopamine and serotonin. This reduction in breakdown could therefore increase the     levels of these neurotransmitters and convey some benefits in regards to mood and cognitive     function. The investigators will assess the pharmacokinetic activity of berry fruit extracts     on MAO activity to test this hypothesis.      A second hypothesis is that berryfruit polyphenols may alter circulating levels of glucose     that may in turn affect cognitive performance and mood.      A prior study carried out by Plant & Food Research through collaboration with the University     of Northumbria, UK, found promising results after acutely supplementing participants with a     berry fruit based drink. This study aims to use the results from the previous study to assess     in depth the effect of berry fruit drinks on human behaviour.   "
135818|NCT01506999|"     The main objective of the GENOCOR project (Genetic mapping for cardiac risk assessment) is     the setting up of a joint public/private laboratory (GENOCOR-LAB) dedicated to the     development and testing of new cost-effective technologies exploiting the growing knowledge     in the genomic correlates of cardiovascular diseases (CVD) and of their evolution; the data     obtained by the GENOCOR-Lab should especially orient secondary prevention and specific     treatment of ischemic heart diseases (IHD).   "
135819|NCT01506986|"     HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo     controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer     bleeding in aspirin users. It will be run by the University of Nottingham, with recruiting     centres across the UK. This trial is funded by the National Institute of Health Research     Health Technology Assessment (NIHR HTA) Programme.      Aspirin use is widespread and increasing in elderly patients. The main hazard is     gastrointestinal bleeding, which may be increasing because of increasing aspirin use. This     trial is based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly     in H. pylori positive people.      Patients will be identified by their GPs, then asked to attend an appointment with a Research     Nurse to consent to the trial and take a H. pylori breath test. Those with a positive result     will be randomised to receive a one week course of either eradication treatment or placebo.     No follow-up visits are required, but instead information will be extracted from the     patients' electronic medical record using the MiQuest search tool.      The trial will continue until 87 adjudicated events (hospitalisation because of definite or     probable peptic ulcer bleeding) have occurred, which would occur after a mean 2.5 patient     years of follow-up, if trial assumptions are correct.   "
135820|NCT01506973|"     In this Phase I/II clinical trial, the investigators seek to pilot the addition of     Hydroxychloroquine (HCQ) to a commonly-used front-line therapy of pancreatic cancer,     gemcitabine/nab-paclitaxel. The investigators plan a run-in to define tolerable doses, and     will explore doses of 800 and 1200 mg/day in successive cohorts of 6 patients. The     investigators will assess toxicity continuously, and determine the dose for the Phase II     trial based on standard toxicity criteria.      The correlative endpoints of this trial are directed to the pharmacokinetics of HCQ, and     pharmacokinetic model of HCQ based on data from several ongoing trials, and the data from     these patients will contribute to refining the model. The investigators will analyze both     measured and model-predicted indices for their relationship to autophagy induction. Autophagy     will be assessed as the accumulation of autophagocytic vesicles in the PMNs of treated     patients, together with the induction of the expression of autophagy-related proteins on     western analysis, quantitated by densitometry. The investigators will document the rates of     metabolic response as a consequence of treatment, as a therapeutic marker that may be related     to the degree of autophagy inhibition. Since the investigators have previously demonstrated a     key role of JNK1 in the induction of autophagy by chemotherapy, the investigators will     analyze archival tumor materials to determine variability in this marker, as a baseline for     potential future trials. Finally, this study will incorporate metabolic profiling by mass     spectrometry, which will be related to mutations (including Kras) in pretreatment tumor     specimens. Mutational analysis will be accomplished by targeted sequencing or by     next-generation sequencing, and the need for fresh tissue for all these endpoints will     require patients to have a biopsy performed before treatment at at 6-8 weeks after beginning     treatment. In the previous study of the Hh inhibitor GDC-0973 with the same chemotherapy, the     investigators were able to obtain repeat biopsies successfully on all patients. The     importance of these biopsies, to move the science forward in an era in which the tools now     exist to provide meaningful correlative science, cannot be overstated.   "
135821|NCT01506960|"     The purpose of this study is to learn more about lipid rich plaque using Near Infrared     Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary     artery stenting and Optical coherence tomography (OCT) imaging.   "
135822|NCT01506947|"     To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant     patients with stage 5 chronic kidney disease.   "
135823|NCT01506934|"     A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of     food on the pharmacokinetics of linifanib.   "
136052|NCT01503944|"     The purpose of this study is to evaluate the ability to identify individuals with     dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia     with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from     Alzheimer's disease (AD) and control subjects.   "
135824|NCT01506921|"     Racemic ketamine and S-ketamine are used in clinical practice today. Little is known of their     difference in effect on cerebral blood flow, volume and metabolism. cerebral blood flow (CBF)     measuring techniques are limited in time so constant measurement to mirror a dynamic process     is impossible or very difficult. A novel MRI application, arterial spin labeling, offers the     possibility that without radiation or contrast, to measure semi-continuous CBF with     measurements every 60-120 seconds. The investigators will give 14 healthy volunteers both     study drugs in a randomised sequence with one week apart and measure regional CBF during the     study period of 45 minutes after a sub-anaesthetic bolus dose of 0,6 mg/kg racemic ketamine     and 0,3 mg/kg S-ketamine The investigators hypothesize that there is no difference between     racemic ketamine and S(+)-ketamine with regards to Arterial Spin Labeling (ASL) measured     cerebral blood flow.   "
135825|NCT01506908|"     Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a     cigarette in smokers   "
135826|NCT01506895|"     The purpose of this study is to characterize the systemic and ocular safety and tolerability,     pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat     administration of oral darapladib in diabetic macular edema patients with centre involvement.   "
135827|NCT01506882|"     The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as     monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in     the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.   "
135828|NCT01506869|"     Phase 1: Baseline investigation (nation-wide survey)      Aims: To investigate whether diabetes and prediabetes is a risk factor for cancers of all     sites as well as for specific type of cancer, such as breast and colorectal cancer.      Subjects and Methods: A nation-wide survey will be carried out in 200,000-250,000 individuals     selected from 20-25 communities stratified according to geographic regions (northeast, north,     east, south central, northwest, and southwest China), degrees of urbanization (large cities     [Beijing, Shanghai, and provincial capitals], midsize cities, county seats, and rural     townships), and economic development status (as assessed on the basis of the gross domestic     product [GDP] for each province). A comprehensive examination including questionnaire,     anthropometric measurements, biochemical analysis will be performed in each study     participant. Diabetes and prediabetes should be diagnosed by OGTT according to the WHO 1999     criteria, while the diagnosis of cancer is established on the self-report questionnaire and     cross checking with the tumor registry or a proof of doctor's diagnosis.      Phase 2: Cohort follow-up      Aims : To examine factors that modify the risk of cancer in diabetes, prediabetes and normal     glucose regulation (NGR).      Subjects and Methods: To recruit and follow all type 2 diabetes, prediabetes, and     sex,age-matched NGR (1:1) in each community for at least 3 years. For diabetes, treatment     target is HbA1c ≤ 7.0% with treatment paradigm recommended by local guideline.   "
135829|NCT01506856|"     The purpose of this study is:      Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion     weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every     3 weeks (dd-TCip therapy).      Phase B: To compare the efficacy and safety of the following two treatment regimens as     first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary     peritoneal cancer.   "
135830|NCT01506843|"     The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody     response changes after SLIT using house dust mite allergen with or without bacterial extracts     in mite-allergic children.   "
135831|NCT01506830|"     During restorative procedures, different isolation methods of the operative field can be used     to promote moisture control and retraction of the gingival tissues. The aim of the present     clinical trial is to evaluate the effects of two isolation techniques on the clinical     performance of Class V restorations, as well on the periodontal conditions of restored sites.     Patients presenting at least two noncarious cervical lesions (NCLs) will be enrolled in this     study. The NCLs will be randomized into the following groups: (1) isolation performed with     rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and     gingival retraction cord. Both techniques will be used with a saliva suction device. All     restorative procedures were performed using a self-etching adhesive system and a nanofilled     composite resin according to the manufacturer's instructions. The clinical performance of     restorations will be recorded in terms of fracture and retention of restoration, marginal     adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth     vitality at 1 week, 6 months, 12, 24 and 72 months after placement. The periodontal condition     of restored sites will be evaluated based on the presence of supragingival plaque, gingival     marginal bleeding, probing depth, and relative gingival recession.   "
135832|NCT01506817|"     The primary objective of the current pilot study is to analyze MRI contrast-enhancement     patterns in the hands of patients with fibromyalgia as compared to the findings in healthy     controls. Further, to compare enhancement patterns obtained in fibromyalgia patients with     those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic     arthritis.      Hypothesis:      Dynamic contrast-enhanced MRI (DCE-MRI) of the hands in patients with fibromyalgia reveals     pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g.     superficial soft tissues and /or muscle with patterns distinct from those of inflammatory     joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.   "
135833|NCT01506804|"     Many patients experience an effect of steroid injection, however the effect is often short     lasting and recurrence of symptoms is common. The short term effect of injection has been     shown to be much better than exercise therapy; however over time the superior effect of     injection compared to exercise does not last. Injection in combination with exercise therapy     might be a more sufficient therapy than injection alone. The aim of this study is to     investigate a combination of steroid injection and a 10 week exercise program. In addition,     the study tests the validity of clinical impingement tests using ultrasound verified     impingement as gold standard.   "
135834|NCT01506791|"     This is an open label, randomised, 2-way crossover, comparative bioequivalence study.   "
136068|NCT01503736|"     The purpose of the study is to determine the effect and optimum dose and evaluate the safety     of ferric citrate, administered three times daily (TID) immediately after meals for a total     daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end     stage renal disease (ESRD).   "
135835|NCT01506778|"     Most of gynecological office procedure such as endometrial sampling procedure,     hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device,     difficult intrauterine insemination or embryo transfer procedures often require the     application of a single tooth tenaculum to the cervix for steady the cervix, straighten the     cervicouterine angle and provide countertraction. However, grasping the cervix with a     tenaculum can be a painful experience for the patient.A randomized controlled trial was     conducted to evaluate using of tenaculum on pain perception of the patients and the procedure     performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.   "
135836|NCT01506765|"     The results of the study schizophrenia, related disorders and glutathione conducted at the     Laboratory of Psychiatric Neuroscience (LUNEP) DUPA of Lausanne, reinforce the hypothesis     proposed that a deficit intracerebral glutathione is a vulnerability factor for Schizophrenia     at least for a subgroup of patients. While pursuing the baseline study, it is appropriate now     to try to restore a higher level of glutathione in patients to see if this increase is     accompanied by an improvement in symptoms, particularly negative symptoms and disorders     cognitive, particularly resistant to current therapy. N-acetyl-cystein (NAC) is a precursor     of glutathione which is used clinically for various indications, well tolerated even at high     doses. The investigators propose a double-blind cross-over with the aim to study if the     N-acetyl-cystein (at a dose of oral 2g/day) leads on the one hand a rising glutathione brain     (measured in resonance magnetic spectroscopic) and also improved patients' conditions     (determined by clinical assessments, psychopathological, neuropsychological, biochemical and     physiological), while recording any side effects. As a first step, this study should include     at least thirty patients and last for two to three years. It is important to note that this     is not a study of medication suggested by a pharmaceutical industry, but a medical search.   "
135837|NCT01506752|"     The purpose of this study is to investigate the bioequivalence of improved and current orally     disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each     of two administration methods (with/without water).   "
135838|NCT01506739|"     The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5     g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated     tablet (5 mg) in Japanese healthy adult males.   "
135839|NCT01506726|"     The purpose of this study is to determine whether treatment of unexplained anemia in older     adults and elevated inflammatory markers with oral salsalate can improve hemoglobin levels     and improve physical activity and quality of life.   "
135840|NCT01506713|"     The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's     Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75     mg tablet under fasting condition.   "
135841|NCT01506700|"     This is a single-arm, prospective, study of an optical imaging device on approximately twenty     (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be     performed on study subjects with results being compared to final pathology.   "
135842|NCT01506687|"     Patients who receive tailored navigation (consisting of a letter and patient navigation     services) and get screened will be significantly greater than the control group who receives     treatment as usual.      A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their     preferred tests, after undergoing the Patient Navigator intervention and that proportion     will be significantly greater than the group who opt for FOBT in the control group.   "
135843|NCT01506674|"     Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be     checked for possible correlations between metabolomics patterns and patients' outcomes.   "
135844|NCT01506661|"     Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV)     that usually occurs decades following initial exposure. The risk of developing shingles     increases with age. Shingles presents as a painful, itchy blistering rash that usually     involves a single portion of the skin and lasts about 7-10 days. The risk of developing     shingles increases with age in healthy people, and has been shown in some studies to be     increased in people with rheumatoid arthritis and other autoimmune diseases.      Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by     the FDA for the prevention of Shingles among people 60 years and older, and is now approved     for use in people aged 50 years and older. Because rheumatoid arthritis and some of the     medications used to treat rheumatoid arthritis can impair the body's immune system, it is not     known how much of an immune response can be generated in people with rheumatoid arthritis.      The goals of this study are to measure the immune response after standard vaccination with     Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune     systems. All participants will be 50 years old or older, and subjects with rheumatoid     arthritis will not be eligible if they are taking certain biologic medications, including TNF     inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid     arthritis will all receive a single vaccination with Zostavax, then will be followed for 12     weeks to assess the immune response and for the development of local rash or other potential     side effects.   "
135845|NCT01506648|"     Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young     children immediately after the addition of the enzyme phytase. A randomized single blind     study   "
135846|NCT01506635|"     In this randomized controlled clinical trial, we compare the effects of timolol versus     placebo for treatment of myopic regression after LASIK   "
135859|NCT01506466|"     Weight variation has been reported as a side effect of chemotherapy treatment in early breast     cancer patients. To date, there is growing evidence for an increased risk of relapse and     death in these patients who gain or lose weight. However, causes of weight variation during     chemotherapy and mechanisms involved in the poor prognosis have been little studied.      Thus, the investigators are conducting a prospective study to characterize weight variation     in terms of body composition and to identify the mechanisms involved.   "
135915|NCT01505738|"     The amount and species of bacteria have been shown to have an effect in wound infections in     several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery     of facial area). In vascular surgery, wound infections are a common and expensive     complication. The aim of the present study is to investigate the prevalence of bacteria in     vascular surgery wounds perioperatively, and determine whether is correlates with the     incidence of wound infections postoperatively.   "
135847|NCT01506622|"     The occurrence of emergence agitation (EA) in pediatric patients who have received     sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between     10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.      Many authors reported various strategies such as use of sedative premedication, change of     maintenance technique of anesthesia, or pharmacological agents administered at the end of     anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from     sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end     of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration     of anesthesia excessively when these agents are administered as subhypnotic or small dose.     The typical agents that can be administered in this way are propofol and fentanyl.      Previous studies demonstrated that the use of either propofol or fentanyl at the end of     anesthesia could reduce the incidence of EA.      The purpose of this study is to compare the preventive effect on EA and the characteristics     of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane     anesthesia.   "
135848|NCT01506609|"     The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide     or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally     recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast     cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.   "
135849|NCT01506596|"     The purpose of this study is to evaluate the effectiveness and safety of single agent     pazopanib in subjects with unresectable or metastatic liposarcoma.   "
135850|NCT01506583|"     Currently effective antivials for influenza treatment are two influenza viral neuraminidase     inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is     reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is     that the signal ratio of two reagents (with or without a single concentration of the drug)     correlates the IC50 value, an accurate measurement of drug resistance but impractical for     clinical use.   "
135851|NCT01506570|"     Dengue viruses can cause dengue fever and other serious health conditions, primarily     affecting people living in tropical regions of the world. This study will evaluate the safety     and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy     adults who have previously been infected with a dengue virus or other flavivirus or have     previously received a flavivirus vaccine.   "
135852|NCT01506557|"     The investigators would like to test the hypothesis that maternal vitamin D supplementation     during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more     effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal     vitamin D status and could be beneficial for maternal and infants bone mineralization and     body composition (proper proportion of muscle and fat tissues in body weight) and is safe for     both.      The investigators also want to confirm that vitamin D supplementation of exclusively     breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status     independently of mother's vitamin D supplementation up to 1200 ID/d.      Additionally the investigators hypothesize that because of changes in lifestyle there will be     no substantial seasonal differences in vitamin D status of pregnant women at the delivery and     their newborn infants.   "
135853|NCT01506544|"     Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to treat     adults with sickle cell anemia. Hydroxyurea has also been tested and used with children with     sickle cell anemia. However, there are not many studies describing the disposition of drug in     children less than 5 years old. The FDA has requested this study to better understand how     children ages 2 to 17 years with sickle anemia absorb and eliminate the drug (this is called     pharmacokinetics). The investigators will measure how much Hydroxyurea (HU) gets into the     bloodstream at different time points after taking this medication.   "
135854|NCT01506531|"     The objective of this study is to scientifically evaluate two different closure strategies     for gastroschisis to determine if there is a difference in the two approaches.   "
135855|NCT01506518|"     This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging     method, Double-Push Acoustic Radiation Force (DP ARF) ultrasound, to monitor the progression     of Duchenne muscular dystrophy. The hypothesis being tested is that DP ARF ultrasound     delineates changes in muscle composition and function in individual dystrophic muscles, from     early through late stages of disease development, that correlate to time to loss of     ambulation in patient volunteers.   "
135856|NCT01506505|"     Background and rationale:      In clinical practice, antihypertensives are generally prescribed for use in the morning,     whereas some statins are recommended for use in the evening. There is evidence that the     reduction in LDL cholesterol achieved with some statins is superior when taken in the night,     but it is unclear whether the additional reduction in LDL cholesterol(and the reported     improvement in BP control when aspirin is taken in the evening) is offset by a reduction in     adherence when taking medication in the evening. Current product labelling recommends night     use for simvastatin and does not state a timing preference for aspirin or blood pressure     lowering medicines. There is therefore uncertainty concerning the best timing of     administration of the polypill. This uncertainty will be addressed by this trial.      Trial design:      Randomised, open label cross over trial (n=75) of the polypill in the morning compared with     the evening administration compared with individual agent administration (acetylsalicylic     acid and blood pressure lowering agents in the morning, and statin in the evening) in     individuals at high risk of cardiovascular disease. Patients will be recruited to the RHP 2c     (acetylsalicylic acid 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorthiazide 12.5mg),     and will be randomly allocated to the sequence of time of administration.   "
135857|NCT01506492|"     The purpose of this study is to test the effectiveness of a brief manualized individual     psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress and     promote psychological well-being in patients with various types of cancer, including     metastatic disease.   "
135858|NCT01506479|"     The purpose of this study is to learn more about the effects of exercise on patients who have     been recently diagnosed with Parkinson's disease (PD). The investigators are going to test     two levels of exercise (moderate to vigorous) against no exercise. The investigators think     that exercise may reduce the symptoms the of PD, and the investigators hope to learn what     level of exercise will offer the most benefit.   "
135860|NCT01506453|"     Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of     vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients     is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and     scheduling regimens, and with varying measures of success. The hypothesis of the study is     that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during     treatment for ALL on the Total XVI protocol (or for those being treated as per TOTXVI     protocol), as measured by two outcome measures: the daily dose of morphine used as needed     for pain in addition to either gabapentin or placebo, as randomized, and the pain scores     assessed daily.   "
135861|NCT01506440|"     This pilot clinical trial studies cognitive assessments in patients with cancer undergoing     chemotherapy. Questionnaires that measure cognitive changes during chemotherapy may help     identify the side effects of chemotherapy.   "
135862|NCT01506427|"     The purpose of this trial is to determine what will be the optimal imaging protocol for Head     and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for     future studies involving [F-18]HX4 in cancer patients.   "
135863|NCT01506414|"     The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO)     in combination with Rituximab are effective and safe in the management of     Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).   "
135864|NCT01506401|"     What is the effect of early high frequency oscillation (HFO) versus a lung-protective     conventional ventilation (CV) strategy (using HFO only as rescue therapy), on all-cause     hospital mortality among patients with severe early acute respiratory distress syndrome     (ARDS)?   "
135865|NCT01506388|"     The use of foley catheter was tested many times and proved to be effective for induction of     labour.   "
135866|NCT01506375|"     The aim of the study is to compare the safety, clinical tolerability, immunogenicity and     efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating     adjuvant, in a short course administration (5 injections over 4 weeks).   "
135867|NCT01506362|"     The objective of the proposed study is to determine whether BL-7040 demonstrates clinical     efficacy in patients with inflammatory bowel disease (IBD).   "
135868|NCT01506349|"     Many patients with celiac disease complain of neurocognitive symptoms such as mental     confusion, grogginess, difficulty with concentration and forgetfulness after exposure to     gluten. However, there is little data on any possible association between impaired cognitive     function and gluten intake in celiac disease. The investigators predict that patients with     celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as     confusion, forgetfulness and difficulty concentrating.      The goals of this study are to determine the prevalence of neurocognitive symptoms after     exposure to gluten in patients with celiac disease and to characterize the nature of these     symptoms both in terms of their duration and severity.   "
135869|NCT01506336|"     The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at     50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to     imatinib.   "
135870|NCT01506323|"     The aim of this study was to determine the usefulness of a portable, meditation-based     intervention called the Mantram Repetition Program (MRP) for Veterans with military-related     posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP     to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego,     California, and Bedford, Massachusetts.   "
135871|NCT01506310|"     The purpose of the study is to test whether four lifestyle intervention programs (diet alone;     diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise),     delivered to women with GDM during 24-26 weeks of gestational age will help women to improve     their metabolic pattern, and decrease the incidence of adverse maternal and neonatal     outcomes.   "
135872|NCT01506297|"     Subjective measures of satiety are correlated with biologic mechanisms of appetite control.   "
135873|NCT01506284|"     The aims of the present study are:        1. To evaluate the effect of the induction of anaesthesia and paralysis in terms of changes          in oscillatory mechanics parameters        2. To evaluate the mechanical properties of the respiratory system in terms of input and          transfer oscillatory impedance in response to PEEP changes   "
135874|NCT01506271|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125     mg or 250 mg doses of MK-7655 to imipenem/cilastatin in adults 18 years or older with     Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the MK-7655 +     imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin     alone with respect to the proportion of participants with a favorable clinical response at     completion of intravenous (IV) study therapy.   "
135875|NCT01506258|"     The purpose of this study is to determine whether the plasticity of autologous intravenous     application of cord blood stem cells would improve the clinical course of asphyxiated     newborns.   "
135876|NCT01506245|"     The aim of this study is to compare the effects of exercise training and family-based     behavioral treatment, either in individual or in group setting, in pre-pubertal children and     their mother.   "
135877|NCT01506232|"     The study aims to evaluate whether or not an EEG (a type of brain scan) is useful in     diagnosing youth with either ADHD, BPD, ASD. Youth with ADHD, BPD, ASD, and healthy controls     (without ADHD, BPD, and ASD) will undergo an EEG, and the results will be analyzed using     brain activity flow pattern analysis (BAFPA). Twenty subjects with each disorder and twenty     without any of the disorders under study (controls) will be evaluated. All subjects will be     comprehensively assessed with structured diagnostic interviews and neuropsychological     testing. All EEG analyses will be conducted under blind conditions. Conditional probability     and receiver operating characteristic (ROC) analyses will examine the diagnostic utility of     the EEG scan, using the clinical diagnosis of ASD as the gold standard.   "
135890|NCT01506063|"     The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg     with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory     investigations and assess relative safety and tolerance, under fed conditions.   "
135891|NCT01506050|"     This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence     study.   "
135892|NCT01506037|"     This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence     study.   "
135879|NCT01506206|"     The investigators propose a test of causality by examining a cohort of patients undergoing     deep brain stimulation (DBS) within the ventral striatum. The investigators will examine     behavior on and off stimulation across a range of tasks that index different forms of     impulsivity. Patients will be studied in both the ON and OFF state - that is, they will be     tested during active deep brain stimulation and 30 min to 1 hour after stimulation has been     stopped (order of state will be counterbalanced across subjects). The investigators specific     aim is to test the hypothesis that enhancing ventral striatal signaling (i.e. ON-state DBS)     will cause more impulsive patterns of behavior across several impulsivity tasks. The     investigators predict that ventral striatal DBS will increase stop-signal reaction time on     the stop-signal task and commission errors on the Go/NoGo task, and increase delay aversion     in a delay discounting paradigm.   "
135880|NCT01506193|"     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'     investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136,     PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine     (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.   "
135881|NCT01506180|"     The purpose of this study is to compare acute ill elderly medical patients in a geriatric     department with general medical departments, and to examine the effects of comprehensive     geriatric assessment in the geriatric setting compared with general medical care.   "
135882|NCT01506167|"     This prospective, multi-center, observational study will assess the safety and efficacy of     Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who     have received no previous treatment for advanced disease and are receiving Avastin in     combination with a standard of care first-line chemotherapy regimen. Data will be collected     for 1.5 years or until death.   "
135883|NCT01506154|"     A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the     Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the     Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis     and/or Subdeltoid Bursitis of the Shoulder.   "
135884|NCT01506141|"     Elaprase, a large molecular protein, is not expected to cross the blood brain barrier when     administered intravenously. A revised formulation of idursulfase, idursulfase-IT, that     differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be     suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration.      This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric     patients with Hunter syndrome and cognitive impairment who are receiving intrathecal     idursulfase-IT and intravenous Elaprase enzyme replacement therapy.   "
135885|NCT01506128|"     The investigators tried to know whether a virus causing cervical cancer could be detected in     menstrual blood and to set up a experimental setting to detect the virus.   "
135886|NCT01506115|"     The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC)     is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused     by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar cholangiocarcinoma     improves biliary drainage and prolongs survival. The aims of this study were to assess the     safety and efficacy of PDT in unresectable HCC with bile duct invasion.   "
135887|NCT01506102|"     The purpose of this study is to establish reference values for thromboelastography (TEM-A) in     healthy pregnant women during labor and 2 hours and 24 hours after delivery.   "
135888|NCT01506089|"     Many human and animal studies over the past 40 years have revealed that ovaries and Fallopian     tubes have a lower temperature than core body temperature, especially around the time of     ovulation and early embryo development. Whether average core body temperature, 37 degrees     Celsius, is ideal temperature for culture has not been prospectively evaluated. The purpose     of this study is to determine whether lowering the incubator temperature by 1 degree Celsius     will result in meaningful improvements in embryo development and pregnancy rates.      Patients participating in this study will undergo routine in vitro fertilization (IVF)     stimulation. Following egg retrieval, patients with at least 8 mature eggs will have those     eggs divided randomly into two groups. Both groups will then under ICSI (intra-cytoplasmic     sperm injection) to fertilize the eggs. The groups will randomly be assigned to control or     study condition. The control condition group will be cultured at 37 degrees Celsius, the     current standard of care. The study group will be cultured at 36 degrees Celsius. All other     culture conditions will be kept identical and embryos will be assessed on day 3 and day 5 of     development.      On day 5, all well-developed blastocysts will undergo biopsy for Comprehensive Chromosomal     Screening (CCS), which will evaluate the chromosomal normalcy of the embryo . Patients will     undergo transfer on the morning of day 6 and the highest quality, chromosomally normal embryo     from each group (the 36 degree cultured embryos and the 37 degree cultured embryos) will be     transferred. If only 1 embryo is available for transfer, the patient will have a single     embryo transfer.      All embryos available for cryopreservation will undergo biopsy for CCS before being frozen.     Some arrested embryos from each temperature group will also undergo genetic analysis to     evaluate chromosomal normalcy or mosaicism.      The female patient will undergo a blood draw at 9 weeks gestation and buccal swabs will be     obtained from the infant(s) after birth.   "
135889|NCT01506076|"     The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg     with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory     investigations and assess relative safety and tolerance, under fasting conditions.   "
135893|NCT01506024|"     The aim of the present study is to explore the most efficient surgical approach in total hip     replacement in short and long term when concerning strength, functionality and postoperative     complications.      The objective is to register muscular strength, hip joint functionality/mobilisation and     complications after total hip arthroplasty (THA) performed by the direct lateral approach     (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified     Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).      The primary working hypothesis is that due to a minimal dissection and reduced trauma in the     muscles, patients will tolerate early hospital discharge better after the AA than the PA and     the DLA. Patients in the AA group are also thought to be more active and maintain muscular     strength and hip joint functionality/mobilisation better than patients in the lateral group.   "
135894|NCT01506011|"     The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10     mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical     status, adverse events and laboratory investigations and assess relative safety and tolerance     under fasting conditions   "
135895|NCT01505998|"     The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10     mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical     status, adverse events and laboratory investigations and assess relative safety and tolerance     under fed conditions.   "
135896|NCT01505985|"     Senior hip fracture patients are the most vulnerable to malnutrition and protein deficiency.     Low protein intake, like vitamin D deficiency, contribute to an increased risk for hip     fracture. Notably, several clinical trials with protein supplementation in senior hip     fracture patients resulted in fewer deaths, shorter hospital stay, and a higher likelihood of     return to independent living. The proposal is to test the effect of an oral nutritional     supplement (ONS) which has been designed to meet the specific nutrient needs of senior bone     and muscle health. The hypothesis is that this ONS will improve functional recovery after hip     fracture (as measured by Short Physical Performance Battery (SPPB)), improve quality of life,     improve muscle mass, and- decrease falls and hospital re-admission after hip fracture.   "
135897|NCT01505972|"     The attendance rate to population based primary screening colonoscopy within NordICC trial     (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%.     The aim of this study is to compare the effect of two different time schedules for sending     invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening     naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive     invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO     group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are     participation in screening colonoscopy within 6 months from the date of invitation, response     and acceptance rate before sending a reminder. The study is powered to detect 7% difference     in participation in screening colonoscopy.   "
135898|NCT01505959|"     Targeted population:      Sleep apnea patients at high cardiovascular risk newly treated by CPAP      Hypothesis:      Improvement in blood pressure after 6 months of CPAP treatment might be greater in the     telemonitoring arm compared to usual CPAP care.      Main goal:      To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular     risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated     follow-up based on a telemonitoring web platform.   "
135899|NCT01505946|"     This is an observational, prospective, longitudinal, multicenter, cohort study designed with     the scope to verify whether or not TGA may predict effectiveness of different FVIII     concentrates class (devoid or rich of VWF) in patient affected by severe or moderately severe     inherited haemophilia A and inhibitors.   "
135900|NCT01505933|"     Sedation is required in infants and children to successfully complete MRI while maintaining     respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk     during MRI examination. Therefore, appropriate drugs need to be selected, administered, and     titrated to achieve these objectives. Propofol is commonly used for sedation in children in     the MRI setting because of its predictability, rapid onset, and offset of action.     Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and     respiratory stability. The rationale of this research is to assess the effect of these drugs     on the upper airway and validate their use in children with upper airway disorders.   "
135901|NCT01505920|"     Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for     diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several     methods have been proposed to reducing pain including submucosal block, paracervical block,     and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine     appeared to be the most common methods used. However, from the investigators experience,     there is significant pain associated with the injection itself.      Lidocaine spray is an effective measure for pain control during minor gastrointestinal and     otolaryngological procedures. It is simple without pain related to application.      An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine     submucosal injection by comparing pain scores at various stages of the LEEP procedure.   "
135902|NCT01505907|"     The primary objective of this dose escalation study is to examine the safety, tolerability,     and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy     male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number     of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis     of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify     the maximum tolerated single dose of CXB909.   "
135903|NCT01505894|"     The primary objective of this trial was to investigate safety and tolerability of multiple     doses of BI 409306 in healthy young and elderly volunteers.      The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple     doses of BI 409306 in healthy young and elderly volunteers   "
135904|NCT01505881|"     To collect additional data relating to safety and indicators of efficacy for patients who     have participated in the 1160.113 study.   "
135926|NCT01505595|"     Proprioceptive weighting changes may explain differences in postural control performance.     Deficits in proprioception are found in a subgroup of patients with low back pain.      The aim of the study is to clarify whether proprioceptive training has a positive effect on     proprioceptive postural control in individuals with recurrent low back pain.   "
135905|NCT01505868|"     This clinical research study is made up of 2 groups and 2 phases.      The goal of Phase 1 of this study is to learn the highest tolerated dose of the combination     of cabazitaxel, carboplatin, and prednisone that can be given to patients with metastatic     CRPC.      The goal of Phase 2 of this study is to learn if adding cabazitaxel to the combination of     carboplatin and prednisone affects how the disease is controlled in patients with metastatic     CRPC.      In both of these phases, the drug combinations will be compared to cabazitaxel alone.      The safety of the drug combinations will be studied in both phases and groups.      Cabazitaxel and carboplatin are both designed to interfere with the growth of cancer cells by     stopping cell division.      Prednisone is a corticosteroid that is similar to a natural hormone made by your body. It is     often given in combination with other chemotherapy to treat cancer.   "
135928|NCT01505569|"     This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS     tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or     carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral     blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation     therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood     stem cell transplant will be given for 3 cycles.   "
135972|NCT01504997|"     The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph     node dissection in patients with stage Ia early gastric cancer.   "
135906|NCT01505855|"     A growing number of patients with Crohn's disease are treated with immunosuppressive agents,     such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have     indicated that immunosuppressive treatment may impair the immunological response to     pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and     Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific     disease, such as Crohn's disease. In addition, predictive factors affecting impaired response     following pneumococcal vaccination have not clearly evaluated in patients with Crohn's     disease. In this study, patients with Crohn's disease will be assessed for serological     response to pneumococcal vaccination. Further, potential predictive factors that impact on     vaccination outcomes and adverse events related to vaccination will be evaluated.   "
135907|NCT01505842|"     Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an     increased risk of developing cancer. The purpose of this study is to determine if visualizing     of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more     abnormalities than conventional colonoscopy without dye spray.   "
135908|NCT01505829|"     This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring     treatment response in ovarian cancer metastases and assess its potential in monitoring     treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across     multiple centres and platforms, assessing reproducibility of the measurement in patients     planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker     in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning     measurements will be correlated with histopathological markers in tumour samples in order to     link the biomarker with response mechanisms.   "
135909|NCT01505816|"     This prospective nonrandomized study comprised patients with cataract, corneal astigmatism,     and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular     Lens will be implanted in the capsular bag. Three months postoperatively, distance,     intermediate, and near visual acuities; spherical equivalent; residual refractive     astigmatism; defocus curve; and contrast sensitivity will be evaluated. A     patient-satisfaction and visual phenomena questionnaire will also be administered.   "
135910|NCT01505803|"     Diabetes Mellitus (DM) is a major risk factor for cardiovascular disease, with 50% of     diabetes-associated deaths being attributed to cardiovascular complications. The     characterising features of DM include: the presence of chronic hyperglycaemia, consequent     upon decreased secretion or action of insulin; dyslipidaemia; and enhanced levels of     oxidative stress and inflammation. Zinc and omega 3 polyunsaturated fatty acids have been     shown to influence each of these outcomes via several mechanisms. This pilot study will     examine the effect of nutritional supplements containing zinc and omega 3 on these outcomes     in a population with type 2 DM.   "
135911|NCT01505790|"     Acute coronary syndromes are related to the development of a platelet derived thrombus on a     ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a     significantly reduced the risk of major adverse cardiovascular events (MACE) after     percutaneous coronary intervention (PCI). However despite these therapeutic innovations, the     rate of MACE in patients treated using PCI and particularly in those suffering of an acute     coronary syndrome is around 5% in randomized trials. Within the factors associated with MACE,     high on treatment platelet reactivity following clopidogrel loading dose has been identified     as a key factor. In fact it is widely recognized that there is a large inter individual     variability in clopidogrel responsiveness. In addition several authors have demonstrated a     strong link between high on treatment platelet reactivity following clopidogrel loading dose     and the occurrence of post PCI MACE. Vasodilator Phosphoprotein index measurement (VASP     index) enables a reproducible, standardized and specific assessment of clopidogrel     responsiveness.      The investigators previous works have demonstrated that a VASP index ≥ 50% had a high     negative predictive value for post PCI MACE in patients undergoing PCI and that tailored     clopidogrel loading dose in order to obtain a VASP index < 50% before PCI resulted in a     reduction in the rate of post PCI MACE.      Prasugrel is a new generation thienopyridine with a faster and more powerful anti platelet     effect compared to clopidogrel. It was shown to be superior to clopidogrel to reduce post PCI     MACE in acute coronary syndromes. However in this randomized trial prasugrel achieved an     excessive blockade of platelet reactivity responsible for a significant increase in bleeding     events in some patients and an insufficient blockade in up to 325% of the remaining patients.      Therefore the investigators hypothesized that a strategy of individually tailored loading and     maintenance dose of clopidogrel may be superior to prasugrel standard therapy in achieving an     optimal platelet reactivity inhibition in acute coronary syndrome patients undergoing PCI.   "
135912|NCT01505777|"     The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and     Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.   "
135913|NCT01505764|"     Cancer is often coupled with a condition called cachexia. In this condition, individuals     continue to lose weight and lean body mass, which means their muscles are getting smaller and     weaker. Studies have shown that cancer patients who are losing weight often are responding     poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy.     Also, people may not want to eat. To date, there are no approved treatments available for     this condition.      This study is going to study the benefits of the use of the study drug, Anamorelin     hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies     done before with the study drug have shown that the drug can help the cachectic condition.     The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl     compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including     measurements of body potassium and nitrogen stores.      In addition to the above, the study will also assess the effect of the study drug on handgrip     strength, body weight, lean muscle mass, quality of life, appetite & food intake, certain     blood markers, energy expenditure (the amount of energy participants burn), functional     performance, safety and tolerability of Anamorelin HCl.   "
135942|NCT01505387|"     The effect of Litramine on weight loss has previously been studied during a 12-week     intervention period with promising results. The present study looks into the effect of weight     maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.   "
135927|NCT01505582|"     Proprioceptive weighting changes may explain differences in postural control performance. In     addition, the respiratory movement has a disturbing effect on postural balance. Postural     balance seems to be impaired in individuals with respiratory disorders. Besides the essential     role of respiration, the diaphragm may also play an important role in the control of the     trunk and postural balance. Deficits in proprioception are found in a subgroup of patients     with low back pain. In addition, disorders of respiration have been identified as strongly     related to low back pain.      The aim of the study is to clarify whether inspiratory muscle training has a positive effect     on proprioceptive postural control in individuals with recurrent low back pain.   "
135916|NCT01505725|"     Background:      - Researchers have been studying behavioral components of nicotine addiction by looking at     how drugs have a reinforcing effect, connecting the stimulation provided by the drug     (nicotine) to the behavior that produces it (smoking). Based on previous studies, researchers     are interested in learning more about how nicotine affects current smokers' responses to     psychological tests and smoking-related cues, and in studying whether certain kinds of     genetic background may affect smokers' responses to these kinds of studies.      Objectives:        -  To compare the effect of nicotine versus denicotinized cigarettes during specific          psychological tests.        -  To compare the effects of smoking cues versus neutral cues on craving, mood, and          autonomic response.        -  To study the effect of genes on nicotine reinforcement and smoking-cue reactivity.      Eligibility:      - Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes     per day for at least 1 year) and are not currently interested in reducing their smoking or     seeking treatment for tobacco dependence.      Design:        -  Pilot session:        -  Participants will practice smoking using the measuring equipment that will be used in          the study.        -  After successful practice, participants will read or listen to music for 1 hour, during          which they are not allowed to smoke.        -  After the 1-hour period, participants will sample study cigarettes that have different          levels of nicotine, and will be asked to guess whether the cigarettes are normal study          cigarettes or denicotinized cigarettes.        -  Baseline session:        -  Blood, urine, and breath samples will be taken at the start of the session.        -  Participants will smoke part of an initial cigarette, and then will read or listen to          music for 1 hour, during which they are not allowed to smoke.        -  After the 1-hour period, participants will give another breath sample and will complete          questionnaires about mood and concentration levels.        -  Trial sessions:        -  Participants will smoke study cigarettes, and will be asked to either respond to          questions about perceived nicotine levels in the cigarettes or press a lever for the          chance to be rewarded with additional puffs of the cigarette. After the session,          participants will give another breath sample and will complete questionnaires about mood          and concentration levels.        -  Participants will also participate in cue-reactivity sessions to test the body's          physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack          of unsharpened pencils). After the session, participants will complete questionnaires on          mood and concentration 15, 30, 45, and 60 minutes after the session.        -  At the conclusion of the last experimental session, participants will discuss the study          with researchers, and may receive a referral list of smoking treatment programs.   "
135917|NCT01505712|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors find better ways to treat cancer.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     Hodgkin lymphoma enrolled on ECOG-2496 clinical trial.   "
135918|NCT01505699|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in samples from patients with acute     lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.   "
135919|NCT01505686|"     MRI imaging in clinically evident inguinal hernia is not routinely used. In other painful     inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. The     aim of the present study is to determine, whether similar inflammatory changes can be     detected with MRI scan in inguinal hernia. Also, patient questionaires are used     preoperatively and postoperatively to determine, if preoperative pain scores can be used as a     predictive value for postoperative prolonged pain/neuralgia.   "
135920|NCT01505673|"     The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a     high-dose insulin regimen (>1.8 units/kg/day) in patients with uncontrolled (HbA1c >7.5%)     type 2 diabetes mellitus will improve blood sugar control.      It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the     mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and     assesses blood pressure, lipid profile, and liver function. Finally it will look at patient     quality of life and safety.   "
135921|NCT01505660|"     Among HIV-infected patients, adherence to antiretroviral medications is one of the most     important determinants of clinical outcomes including viral suppression, viral resistance,     disease progression, and death. Unfortunately poor adherence among patients with HIV is very     common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse,     and mental illness particularly depression symptoms are key predictors of poor adherence,     common among HIV-infected individuals, and important to identify and treat among nonadherent     patients. This study will examine the ability of patient reported outcomes (PROs) and a     targeted care management approach to improve clinical outcomes with a randomized controlled     trial (RCT) in routine clinical care of patients with HIV. The investigators will determine     whether healthcare delivery team notification of PROs including antiretroviral medication     adherence and barriers of adherence such as depression and substance abuse along with     tailored intervention recommendations and targeted care management leads to improvement in     both process and clinical outcomes including patient-reported outcomes. The investigators     will examine process outcomes such as use of clinic support services, and patient outcomes     such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.   "
135922|NCT01505647|"     This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process     [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to     ZOSTAVAX™.   "
135923|NCT01505634|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125     mg or 250 mg doses of MK-7655 to imipenem/cilastatin in adults 18 years or older with     complicated urinary tract infection (cUTI). The primary hypothesis is that the MK-7655 +     imipenem/cilastatin treatment regimen is non-inferior to imipenem/cilastatin with respect to     the proportion of participants with a favorable microbiological response at completion of     intravenous (IV) study therapy.   "
135924|NCT01505621|"     Accumulation of damaged proteins is thought to underlie many degenerative conditions,     including aging, diabetes, Alzheimer's disease, cataracts, and others. Over time, proteins     can be irreversibly damaged by a variety of factors, such as reactive oxygen species, and     without timely degradation they can accumulate and aggregate. We believe this can contribute     to the development of chronic degenerative disorders.      The purpose of this study is to develop a novel methodology for measuring protein     accumulation and test it in two groups of people: young (18-30 years) and old (≥65 years).     This methodology will require that people drink a solution of essential amino acids that     includes isotopically labeled L[ring-13C6]phenylalanine. We will then collect blood and     muscle samples, to isolate plasma and skeletal muscle proteins. Participants will return to     the study center four more times on a weekly interval.      We hypothesize that older proteins, which persisted in circulation and accumulated over time,     will have a higher degree of post-translational oxidative damage than newly synthesized     proteins.   "
135925|NCT01505608|"     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for     early relapsed neuroblastoma. An investigational drug is one that has not yet been approved     by the Food and Drug Administration. This investigational drug is called TPI 287. This study     will look at the tumor's response to the study drug, TPI 287, in combination with Irinotecan     and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will     also evaluate the safety and tolerability of the study drug, TPI 287.   "
135929|NCT01505556|"     Proprioceptive weighting changes may explain differences in postural control performance. In     addition, the respiratory movement has a disturbing effect on postural balance. Postural     balance seems to be impaired in individuals with respiratory disorders. Increased risk of     falling is reported in individuals with chronic obstructive pulmonary disease. Besides the     essential role of respiration, the diaphragm may also play an important role in the control     of the trunk and postural balance.      The aim of the study is to clarify whether proprioceptive postural control is impaired in     individuals with diaphragm paresis.   "
135930|NCT01505543|"     Proprioceptive weighting changes may explain differences in postural control performance. In     addition, the respiratory movement has a disturbing effect on postural balance. Postural     balance seems to be impaired in individuals with respiratory disorders. Increased risk of     falling is reported in individuals with chronic obstructive pulmonary disease. Besides the     essential role of respiration, the diaphragm may also play an important role in the control     of the trunk and postural balance.      The aim of the study is to clarify whether proprioceptive postural control is impaired in     individuals with chronic obstructive pulmonary disease.   "
135931|NCT01505530|"     This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in     participants with locally advanced/inoperable or metastatic pancreatic cancer, and will     investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.   "
135932|NCT01505517|"     The aim of the study is to clarify whether specific loading of the inspiratory muscles     induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals     with recurrent low back pain.   "
135933|NCT01505504|"     Weight loss is a frequent problem associated with Alzheimers disease (AD). Mirtazapine has     weight loss as a frequent side effect.      The aim of this retrospective study is to check whether mirtazapine 30 mg (once daily) can     counteract weight loss in patients with AD or mixed dementia (AD + vascular).   "
135934|NCT01505491|"     This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to     establish pharmacokinetic equivalence of BI 695501 to adalimumab.   "
135935|NCT01505478|"     The investigators will conduct a prospective cohort study to compare an automated sepsis     severity score to a conventional clinical prediction rule to risk stratify patients admitted     from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.   "
135936|NCT01505465|"     Pain, confusion, and breaks in normal sleep cycles have been challenges commonly faced by     patients after undergoing joint surgeries. To address these issues, melatonin, an inexpensive     over-the-counter supplement, has shown in previous to help manage sleep disorders, prevent     and treat post-operative confusion in patients over 70 years of age, and reduce pain. The     purpose of this study is to establish whether melatonin can aid in reducing pain and     post-operative confusion and improve sleep quality after total knee replacement   "
135937|NCT01505452|"     The purpose of this study is to clinically demonstrate a phenomenon of measurement error that     can occur during placement of a specific type of total knee replacement prosthesis (single     radius femoral component) using a certain type of surgical technique (flexion/extension gap     balancing).   "
135938|NCT01505439|"     This study is to investigate the effects of solifenacin on urgency urinary incontinence     symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically     significant stress urinary incontinence accompanied by urgency urinary incontinence.   "
135939|NCT01505426|"     To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian     subjects with type 2 diabetes mellitus.   "
135940|NCT01505413|"     Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth     factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine     kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong     case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the     addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in     advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin     is superior to gemcitabine alone in terms of progression free survival and response rate in     one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and     oxaliplatin may further improve the overall survival and clinical benefit of advanced     pancreatic cancer.   "
135941|NCT01505400|"     Substantial progress has been made in the treatment of cancer through the use of targeted     therapies, but what works for one patient might not work for another patient. Certain drugs     are now being developed that target specific molecules in the body that are believed to be     part of the disease.      Biomarkers are specific characteristics of the cancer that may help provide prognostic     information (i.e. how well patients will be regardless of the treatments given) or help     predict sensitivity or resistance to a specific treatment.      The study will collect archival tumor samples (previously collected biopsy or surgical tumor     samples) to provide biomarker data about a patient's cancer, in order to help their     physicians to identify which clinical trials of molecularly targeted therapies may be most     appropriate for the patient in the future.   "
135943|NCT01505374|"     Currently, the regional anesthetic standard of care for total knee replacement surgery is     combined spinal/epidural to provide long-lasting pain relief with or without a femoral nerve     block (FNB). The femoral nerve block refers to a technique that your anesthesiologist can use     to numb the thigh muscle for approximately 18 hours after surgery. While this technique     offers significant pain relief, it is possible it may cause muscle weakness and increase     patients' recovery times. Hence there is a need for an alterative anesthetic technique, one     that may help minimize postoperative pain as effectively as a femoral nerve block, while not     causing weakness of the thigh muscle.      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it     is hypothesized by blocking or anesthetizing the saphenous nerve with local anesthetic     closer to where it branches off, the area around and below the knee will feel numb. Yet     unlike the femoral nerve block, the thigh muscle itself will still be able to function.      For patients undergoing two total knee replacements at one time or bilateral total knee     replacement, they will be randomly assigned to receive a femoral nerve block on one leg and a     saphenous block on the other. Pain levels will be measured and thigh muscle strength will be     tested using a dynamometer before surgery, 6-8 hours following anesthesia administration, and     on postoperative days 1 and 2.   "
135944|NCT01505361|"     In previous studies, the investigators have seen that carefully-selected Lactobacillus     strains are a good alternative to antibiotics for the treatment of lactational mastitis. The     objective of this new study is to check if they can also have a preventive role when     administered to women with a history of mastitis with one or more previous infants. Since the     investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting     intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of     resistant bacteria), the investigators would also like to test if administration of the     strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a     mastitis-predisposing factor would de avoid.   "
135945|NCT01505348|"     This study examined changes in bone metabolism (markers of bone turnover, calcium metabolism)     with a bout of acute treadmill running preceded by either a single, mixed meal or an     overnight fast.   "
135946|NCT01505335|"     The purpose of this human clinical trial is to validate the accuracy of Jetguide® US device     in detecting the inferior alveolar canal (IAC) and to compare it to measurements performed on     computerized tomography images.   "
135947|NCT01505322|"     Can pain impairment of daily activities be shown to be procedure specific, and thus used as     an alternative to pain scoring.   "
135948|NCT01505309|"     The purpose of this study is to investigate the short to mid term efficacy and safety of     Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as     descending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type B dissection, dissection with     primary tear located in the aortic arch, et al.   "
135949|NCT01505296|"     The objective is to compare the progression of Atrial Fib (AF) burden by continuous     monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation     (PVI) versus anti-arrhythmic drug (AAD) therapy.   "
135950|NCT01505283|"     There are many methods used for the assessment of pain in the area of anesthesia including     heart rate variability which reflects the influence of the autonomic nervous system on the     heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during     anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious     patients with a comparison of ANI with the measurement of pain by a visual analog scale     (VAS).      Evaluation of ANI is performed just before epidural catheter insertion and during the 10     first minutes after saline, sufentanil or lidocaine epidural administration.   "
135951|NCT01505270|"     It is known that several psychological and medical comorbidities are frequently found among     children suffering from autistic spectrum disorders. Our aim is to investigate which     comorbidities are most common among those children and whether there are differences among     the different ethnic groups found in Israel.   "
135952|NCT01505257|"     Delirium (acute confusion) is common and costly in persons with dementia, resulting in longer     hospital stays, more complications, and greater functional decline. This research tests the     use of the electronic health record, education, and regular feedback to nurses to improve     detection and management of delirium. Ultimately, findings will direct ways to improve acute     care of this vulnerable population.   "
135953|NCT01505244|"     Children in the U.S. exhibit low levels of physical activity. In addition to the overall     physical health and fitness benefits with increasing levels of physical activity,     improvements in academic performance, mental cognition, and behavior may occur. Despite these     benefits, opportunities for children to participate in physical activity are being reduced,     particularly in schools.      The proposed study is a pilot program with approximately 100 children ages 7-11 years     expected to participate. All study participants will partake in a testing and measures     session which will include body composition measures, nutrition and physical activity     questionnaires, and curriculum-based measures. Following the first testing and measures     session, 50 of the 100 children will participate in a 10-12 week, before-school, moderate to     vigorous physical activity (MVPA) program. This program will consist of non-competitive, MVPA     and occur 3 days/week at their school. Subsequent to the physical activity program, all 100     children will then participate in a follow-up testing and measures session.      The objective of this proposed pilot study is to determine the feasibility of implementing a     before-school, physical activity program as well as explore the effect the program may have     on academic performance and health measures.   "
135954|NCT01505231|"     Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery,     with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory     phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can     be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The     investigators hypothesized that the use of arginine vasopressin would be more effective on     treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end     point of mortality and severe morbidity.   "
136083|NCT01503541|"     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the     laboratory may help doctors identify and learn more about biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid     leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.   "
135955|NCT01505218|"     Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography     (ERCP). Combination of sedatives and opioids is associated with increased     morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system     (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative     studies with PCS for ERCP are few. Therefore, the main objective of this randomized     controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists     during ERCP.   "
135964|NCT01505101|"     Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk     of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of     opioids may result in hyperalgesia, which exacerbates opioid craving and consumption.     Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes,     and substance use. The investigators hypothesize that relative to a support group control     condition, participation in a novel mindfulness-oriented cognitive intervention,     Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and     decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients     receiving opioid therapy.   "
135956|NCT01505205|"     Mutations of tumor-related genes are dynamic. Gastrointestinal stromal tumor cells often are     obviously more invasive in case of recurrence. The great majority of relapses may be     associated with secondary mutation in the GIST related genes. Full gene sequences of     c-KIT、PDGFRA and DOG1, which is extracted from the specimen cells of repeated surgical     resection or biopsy tissue in GIST patients with postoperative recurrence, are analyzed with     the screening-sequencing approach, in order to investigate the characteristics and variations     associated with the different gene mutations of c-KIT、PDGFRA and DOG1 in GIST patients and be     likely to find out the evolutionary pattern, try to learn the facts about the effect of     tyrosine kinase inhibitors on the GIST related genes, make a survey of any association of     c-KIT、PDGFRA and DOG1 gene mutations and provide the basis for seeking molecular marker of     GIST for monitoring course of disease, and offer a theoretical basis and new therapeutic     strategies for application of clinical treatment.   "
135957|NCT01505192|"     Aim of this study is to determine the physiological reference individual values (RI) of     maternal continuous SpHb immediately after delivery in the post-partum period (continuous     monitoring up to 2 hours after delivery) in order to establish the physiological Hb     variations in response to the physiological blood loss due to delivery.      During labor all parturients will be tested for standard Laboratory Hb and monitored for at     least 30 minutes with SpHb monitoring equipment (Radical-7™ Pulse CO-Oximeter and Rainbow     DiSposable™ Adult Adhesive Sensor), and these values will be considered to be the baseline     values.      Immediately after spontaneous vaginal delivery, venous blood sample will be taken for Hb     determination and Radical 7 equipment for SpHb will be connected to the patient's finger and     will be recorded for at least two hours after delivery. At the end of this period of     observation a venous blood sample will be taken for Hb determination. Additional measurements     of both SpHb and Lab Hb will be performed 24 hours after delivery.   "
135958|NCT01505179|"     The purpose of this study is to determine whether treatment with Ranolazine will improve     exercise capacity in patients with Heart Failure with preserved left ventricular ejection     fraction.   "
135959|NCT01505166|"     Preliminary studies with a variety of vaccines suggest target accessibility (potential     immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to     overcome limitations of immunostimulatory cancer vaccines, Gradalis has designed a novel     autologous vaccine to address inability to fully identify cancer associated antigens, antigen     recognition by the immune system (i.e. antigen-->immunogen), effector potency, and     cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer     vaccines, we designed a novel dual-modulatory autologous whole cell vaccine, Vigil™,     incorporating the rhGMCSF transgene and the bifunctional shRNAfurin (to block proprotein     conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer     associated antigens, 2) effect antigen recognition by the immune system, 3) enhance effector     potency, and 4) subvert endogenous cancer-induced immune resistance. We have also completed     the Phase I assessment of Vigil™ vaccine in 30 advanced solid tumor patients (1.0 x 10^7     cells/injection/month for a maximum of 12 vaccinations) who have not experienced any     significant adverse effects following 144 vaccinations, including 6 patients with colorectal     carcinoma. Plasmid functionality, immune biomarker response, and preliminary evidence of     anticancer activity have been observed. This is a two-part Phase II study of the Vigil™     autologous vaccine. Six patients will be enrolled into the Part 1 of the study to receive     intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7 cells/injection; maximum of 12     vaccinations). Part 2 of the study will be a randomized Phase II study of sandwich or     adjuvant chemotherapy and intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7     cells/injection; maximum of 12 vaccinations) versus sandwich or adjuvant chemotherapy and     placebo in patients with colorectal carcinoma with either synchronous or metachronous liver     metastases (CLM +/= pulmonary metastases) following resection +/= ablation with curative     intent.Sandwich therapy indicates a combination of both pre-operative and postoperative     chemotherapy as opposed to neo-adjuvant (all chemotherapy prior to surgery) or adjuvant (all     chemotherapy following surgery) therapy. A minimum harvest aliquot to produce 4 monthly     injections will be required for entry into the study. Patients in whom insufficient tissue     (<4 doses) is collected or whose vaccine fails manufacturing release criteria will not     receive vaccine.   "
135960|NCT01505153|"     This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar     invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral     (IT) injection. Patients with superficially accessible advanced cancer following prior     therapies will be entered into the study following a modified dose escalation design based on     the demonstrated safety of our previous clinical experience (BB-IND 13744) with the same     liposome and vector DNA backbone expressing a different transgene (of which doses up to 7 mg     DNA IV/single dose have been administered). Patients will accrue in 4-patient escalation     cohorts using a modified Fibronacci escalation schema (100%-50%-33%-33%) at a starting     intratumoral dose of 0.010 mg/kg of DNA through a dose of 0.053 mg/kg DNA intratumoral /     single dose. Should a single, but not more than two (2), ≥ Grade 3 Dose Limiting Toxicity     (DLT) occur in any cohort, following mandated review (see below) an additional two (2)     patients will be accrued at that dose (total of six). If more than one ≥ Grade 3 toxicity     occurs in any cohort, the preceding dose cohort will be expanded to six (from four) and if <     2/6 patients experience ≥ Grade 3 toxicity, that dose will be the Phase II recommended dose.     Should no ≥ Grade 3 toxicity occur in any cohort (other than Grade 3 local injection site     reaction), an additional two (2) patients will be treated at 0.053 mg/kg DNA intratumoral /     single dose.   "
135961|NCT01505140|"     Walnuts as a whole food contain polyunsaturated fatty acids, anti-oxidants, and other     nutrients essential to sperm development and function. This randomized controlled trial     sought to determine if a Western style diet supplemented with walnuts would improve sperm     quality as a predictor of male fertility.   "
135962|NCT01505127|"     The purpose of this study is to confirm the efficacy of triple therapy with TAK-438,     Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to     triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive     patients with scarred gastric or duodenal ulcers.   "
135963|NCT01505114|"     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of     antiretroviral (ARV) medications before exposure to HIV. This study will evaluate the safety     and tolerability of four ARV regimens in preventing HIV infection in men who have sex with     men who may be at risk of getting HIV infection through sex and women who may be at risk of     getting HIV infection through sex. The four ARV regimens being evaluated are maraviroc (MVC),     MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC.     The MVC-containing arms will be compared to TDF/FTC alone and in combination.   "
135965|NCT01505088|"     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with     dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery     System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with     non-infectious anterior segment uveitis.   "
135966|NCT01505075|"     The purpose of this study is to determine the safety and efficacy of a short course of     radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer     currently being managed with primary androgen deprivation therapy (PADT).   "
135973|NCT01504984|"     The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by     comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T     (400mg) when administered a single-dose to healthy male volunteers.   "
135974|NCT01504971|"     Aim of this study is to compare the efficacy of narrow band imaging (NBI) and     autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux     that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the     diagnosis of gastroesophageal reflux disease (GERD).   "
135975|NCT01504958|"     This study looks at the potential benefits of combining cognitive training (mental exercises)     together with transcranial magnetic stimulation (also known as TMS) to see if this can make a     difference in the condition of people with Alzheimer's disease by improving their disease and     the cognitive decline that goes along with it.   "
135976|NCT01504945|"     Patients with a low blood count (anemia) with stable or unstable coronary artery disease     consistently show worse clinical outcomes. It is unclear whether this association is     confounded since anemic patients tend to be also sicker i.e. have lower ejection fractions or     more comorbidities and this would be the reason for the worse outcomes rather than anemia.     The coronary arteries are a unique vascular bed insofar that across the cardiac circulation     oxygen extraction is close to maximal at rest. Thus increases in demand can only be met by     increases in blood flow and hemoglobin concentration since oxygen extraction is maximal at     rest. It is natural to assume that maximization of oxygen delivery in the setting of active     coronary syndrome (ACS) is beneficial to the patient since oxygen extraction and coronary     blood flow is fixed. In fact, in most intensive care units patients with ACS are transfused     to a HCT of 30%. However, retrospective analysis of trial data showed at best mixed results     in clinical outcome when patients with ACS were transfused and in fact in some studies showed     consistently worse outcomes than non-transfused patients. Similar disappointing results have     recently published in patient who underwent coronary artery bypass grafting (CABG).      This study is designed to determine the effect of red blood cell (RBC) transfusion on oxygen     consumption, cardiac, microcirculatory and endothelial function in patients with active     coronary artery disease. For this study active coronary artery disease will be defined as the     patient having undergone within the past 4 days of recruitment either a myocardial infarction     due to atherothrombosis (AHA type I myocardial infarction) or surgery for coronary artery     bypass grafting.      In specific this study will test the hypothesis whether RBC transfusions improves cardiac and     vascular function in patients with a hematocrit of less than 30% with active coronary artery     disease.      Aims of this study are to determine whether RBC transfusion in patients with active coronary     artery disease and anemia:        -  increases oxygen delivery to the peripheral tissues.        -  increases whole-body oxygen consumption.        -  decreases nitric oxide bioavailability, endothelial, microcirculatory, and myocardial          function, and/or increases platelet aggregation   "
135977|NCT01504932|"     This pilot clinical trial studies freeze-dried black raspberries in preventing oral cancer     recurrence in high-risk Appalachian patients previously treated with surgery for oral cancer.     Chemoprevention is the use of certain drugs to keep cancer from forming. Giving freeze-dried     black raspberries may prevent oral cancer from forming   "
135978|NCT01504919|"     The goal of this research study is to learn if a wellness program can help improve diet and     physical activity levels and encourage smoking cessation in Latino individuals who are     overweight.   "
135979|NCT01504906|"     The purpose of this study is to assess the effect of Cyclosporine on the blood levels of     Ticagrelor.   "
135980|NCT01504893|"     The purpose of this study is to determine if a protective ventilatory strategy during     one-lung ventilation (OLV) could reduce postoperative complications after thoracotomies or     thoracoscopic pulmonary resection.      Primary endpoint: Evaluation of Acute Lung Injury (ALI) incidence      Secondary endpoint: postoperative outcome (hospital stay, morbidity, mortality and their     correlation with preoperative comorbidity and surgery technique.   "
136014|NCT01504451|"     This study is designed to compare three different techniques in ablation of paroxysmal atrial     fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system,     the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and     minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and     Biosense Webster ablation are non-inferior to Medtronic ablation.   "
136015|NCT01504438|"     This is a randomized study to prospectively compare and evaluate the functional outcome and     patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either     the STAR or Salto-Talaris prothesis.   "
135981|NCT01504880|"     The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and     tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic resonance     imaging (CMR) as the non-invasive gold standard compared to transthoracic echocardiography     (TTE) to evaluate measurements of the width of the regurgitation jet (vena contracta (VC)) to     demonstrate the utility of the VC as a means to objectively evaluate atrioventricular valve     regurgitation. In addition, feasibility and other quantitative and qualitative measures of     regurgitation will be compared between CMR and TTE.        -  Hypothesis 1: The ability to objectively evaluate atrioventricular valve regurgitation          and VC width with TTE and CMR has a high feasibility rate with acceptable intra and          inter-observer variability by two independent readers.        -  Hypothesis 2: There will be positive correlation between the TTE measurement of the VC          width and quantitative assessment of atrioventricular valve regurgitation by TTE and          CMR.        -  Hypothesis 3: There will be a positive correlation between the quantitative measurements          of atrioventricular valve regurgitation by phase contrast velocity encoded CMR with          quantitative values as measured by TTE.        -  Hypothesis 4: There will be a positive correlation between qualitative assessment of          atrioventricular valve regurgitation by CMR compared to TTE.   "
135982|NCT01504867|"     The primary hypothesis was that early aspirin administration will decrease the rate of     developing acute lung injury during the first 7 days after presentation to the hospital.   "
135983|NCT01504854|"     Resveratrol is derived from plants and is found in highest levels in red wine and the skin of     red grapes. A recent study reported that monthly and weekly consumption of red wine is     associated with a lower risk of dementia. There is compelling evidence that caloric     restriction can improve overall health by activating a class of enzymes known as Sirtuins.     Resveratrol is a substance found in some plants that directly activates sirtuins, mimicking     the effects of caloric restriction and may affect regulatory pathways of diseases of aging,     including Alzheimer's disease (AD).      In this study, people with AD will be given either Resveratrol or placebo for 12 months to     determine whether daily resveratrol therapy is beneficial in delaying or altering the     deterioration of memory and daily functioning. Subjects age 50 and above with a diagnosis of     probable AD may qualify for participation in this study. A small group of 15 participants     will be asked to take part in a more detailed 24-hour Pharmacokinetic (PK) sub-study that     will measure resveratrol levels over a 24 hour period.   "
137333|NCT01487148|"     This study is designed to compare the performance of the P-1000 System, POCARED's Rapid     Diagnostic System which uses optical fluorescence analysis, to standard methods of     uropathogen quantification and identification.   "
135984|NCT01504841|"     Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of     combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is     increasing, leading to treatment failure. This study will test the safety, tolerability, and     dosing levels of etravirine (ETR), a new NNRTI.   "
135985|NCT01504828|"     Normal aging is characterized by altered cardiovascular function. Our preliminary data with     MR imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension     show that age-related cardiac dysfunction is characterized initially by impaired relaxation     of the heart (40 - 60 years), and then at > 60 years altered contraction and impaired     myocardial energetics. For the first time, the investigators will test whether the functional     and energetic effects of normal aging can be reversed by acutely reducing stiffness of     peripheral blood vessels using an ACE inhibitor. This will potentially have important     insights into how normal aging affects the heart, and how potential treatments could be used     to attenuate this process.   "
135986|NCT01504815|"     This Phase III trial aims to:      Explore the impact of pre-treatment information and radiation dose redistribution on     locoregional control in patients with locally advanced SCCHN.      The dose to the primary tumor with margins, based upon PET and CT information, will be     inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards     the edges of the irradiated area.      To determine the toxicity of combined modality treatment (cisplatin) with standard dose     distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous     radiation dose distribution.   "
135987|NCT01504802|"     It is now widespread practice to treat children with short stature with growth hormone.     However, how an individual child will respond to growth hormone treatment is unpredictable     and highly variable. Some children will not respond to growth hormone treatment at all.     Currently, the only way to determine how well growth hormone therapy is working is to wait     until they have been treated for six months and to compare the pre-treatment growth velocity     with the growth velocity on treatment. It would be helpful to have a blood test that could be     done shortly after starting growth hormone that could predict whether how well a child is     responding to treatment. Such a blood test would allow endocrinologists to adjust the growth     hormone dose (or possibly stop it altogether, if it is not working) long before the six     months it currently takes.      C-type natriuretic peptide (CNP) and its partner amino-terminal propeptide of CNP (NTproCNP)     are proteins that play a critical role in regulating growth. The investigators have     previously shown that blood levels of these proteins increase in children being treated with     growth hormone. The investigators believe that a blood test for these proteins will be useful     in predicting a child's response to growth hormone treatment.      The purpose of this study is to determine when after starting growth hormone, the blood     levels of CNP and NTproCNP start to increase.   "
135988|NCT01504789|"     The goal of this research study is to test an exercise program that is designed for Hispanic     breast cancer survivors. Researchers want to learn the most effective strategies for     promoting exercise.   "
135989|NCT01504776|"     The purpose of this study is to determine the safety and clinical efficacy of the combination     of panobinostat plus bortezomib.   "
135990|NCT01504763|"     The purpose of this study was to assess the feasibility and effect of chair massage provided     during working hours for nurses in an inpatient psychiatric and an outpatient pain     rehabilitation unit and on the nurses stress related symptoms.   "
136016|NCT01504425|"     The investigators aim to define the concept of difficult colonic polypectomy and investigate     whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic     submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement,     submucosal injection) and operator experience have an impact on polypectomy outcomes and     complication rate.   "
136017|NCT01504412|"     The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared     to placebo, in subjects with pain associated with diabetic peripheral neuropathy.   "
135991|NCT01504750|"     Rationale:      Many study reports described benefits of natural sunlight. It is believed that artificial     light can achieve similar benefits as sunlight and can be used to compensate for the lack of     sunlight, for instance in north-facing hospital rooms or during wintertime.      The most plausible paths mediating the effects of light are:        -  the biological effect of light, relating to circadian biology and the sleep/wake-rhythm;        -  the emotional/psychological effects of light, relating to mood/stress and the          antidepressant action of light .      Objective:      The project aims to measure, evaluate and quantify the beneficial effects of a dynamic     daylight & atmosphere experience in patient rooms for cardiovascular patients during the dark     months of the year.      Study design:      The study involves an experiment in which psychological, emotional and clinical parameters of     patients in hospital rooms with standard light situation are compared with those of patients     in rooms with a dynamic daylight & atmosphere experience.      Study population:      The population includes cardiovascular patients who reside in the general cardiology     department of the Maastricht University Hospital (18 patient beds) with an intended minimum     length of stay of 3 days, who have given written consent.      Intervention:      Half of the patient rooms on the ward are equipped with special luminaires. In the ceiling,     luminaires are installed that offer the basic lighting in the patient room that will     automatically and gradually change in light level (100-300 lux) and color temperature     (3000-4000 K). This so called daily rhythm light meets the EN12464-1 standard for patient     rooms in hospitals. The same luminaires in the ceiling will also offer the light boost by     bringing the illuminance to a level of maximal 2000 lux and 7000 K, during a period of two     hours in the morning. Besides the ceiling luminaires, a low intensity color cove as well as     some white LED spots are added to create a pleasant ambience in the patient room      Main study parameters/endpoints:      The primary study measures are length of stay and quality of recovery expressed by     physiological, emotional and clinical parameters. Also the effect on patient satisfaction is     determined using pre and post assessments.   "
135992|NCT01504737|"     SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due     to a growing elderly population. The therapy is aortic valve replacement (AVR). Studies on     postoperative rehabilitation of AS pts are scarce. In the few studies available, a mix of     valve diseases is presented without considering the differences in pathophysiology and the     training regimes are not clearly described.      PURPOSE, AIMS & HYPOTHESIS The investigators purpose is to evaluate whether a supervised     cardiac rehabilitation program improves the objective physical capacity and quality of life     (QoL) of patients after AVR due to AS, and compare this to patients training by their own.     The investigators hypothesize that supervised exercise training may be a more efficient way     of rehabilitating these patients.      DESIGN This is a controlled randomized clinical trial comparing 12 weeks of supervised     exercise training 3 times per week to home-based training based upon public health     recommendations of minimum level of physical activity.      SIGNIFICANCE & IMPLEMENTATION Positive results would support that an organized program of     exercise training improves physical capacity and QoL in AS patients following AVR with     potential benefit for both patients and society.   "
135993|NCT01504724|"     This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before     panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and     retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without     macular edema.   "
135994|NCT01504711|"     This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in     patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs,     such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients     treated with chemotherapy.   "
135995|NCT01504698|"     The purpose of this study is to determine the effect of manipulative treatment of children     with neck and back pain. Because manipulation is the most frequently used treatment of     musculoskeletal complaints in children, and an increasing number of Danish children see a     chiropractor, it appears obvious to start the search for evidence by examining the effect of     this treatment.   "
135996|NCT01504685|"     The purpose of the study is comparatively analyze the advantages and disadvantages of banded     versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).      The outcome variables of the general study included morbidity, maximal weight loss, and late     weight regain.   "
135997|NCT01504672|"     The aim of this randomized controlled study is to investigate if medication reviews performed     by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce     readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive     failure.      Four hundred and sixty patients will be recruited and randomized to control (usual care) and     intervention group (enhanced service in which a pharmacist is part of the health care team).      Six months after the last patient of the 460 has been discharged the study will be closed.     Data about the number of readmissions and visits to the emergency room will be collected     during the six-month follow-up and also, the costs associated with each visit or admission.     Time until institutionalization will be compared between intervention group and control     group.   "
135998|NCT01504659|"     The investigators plan to evaluate the efficacy and safety of intranasal Ketalar (ketamine     hydrochloride) in the treatment of primary symptom manifestations of pediatric bipolar     disorder; Fear of Harm (FOH) phenotype. This phenotype represents those children who are most     resistant to traditional treatments and suffer repeated hospitalizations. Primary symptoms     include fearfulness, aggression secondary to threat, mood and/or arousal instability, and     psychosis. In addition to evaluation of efficacy and safety, the investigators will also     analyze whether therapeutic response depends upon the degree to which the subject fits the     FOH phenotype.   "
135999|NCT01504646|"     The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on     airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals     with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to     placebo, will significantly attenuate airway inflammation and hyperpnea-induced     bronchoconstriction in asthmatic individuals.   "
136000|NCT01504633|"     Rationale: Review on the positive effect of long chain polyunsaturated fatty acids (LCPUFA),     especially docosahexanoic acid (DHA), supplementation on cognitive function in human using     randomized controlled trials (RCTs) showed that results in RCTs were mixed and inconsistent.     It has been suggested that the effect may be subtle, which is currently difficult to detect,     but could be significant, or there may be individual variation which mediate the effect.      Objectives: This study aims to assess gene-nutrient inter-relation in explaining the effect     of LCPUFAs i.e. DHA and/or iron on cognitive functioning of children <24mo in Indonesia.     Specifically the study's objectives are: (1) to assess effect of LCPUFA (as DHA oil) and iron     (as iron supplement) in altering gene expressions, and (2) to assess the mediating effect of     genes involved in fatty acid and iron metabolism in improving serum LCPUFA, alpha-linolenic     acids (ALA), DHA and cognitive function.      Study design and study population: The study is a double-blind randomized controlled trial     with children aged less than 24 months (window of opportunity). The study area is in East     Lombok district, in West Nusa Tenggara province, Indonesia where nutrient intake including     iron and presumably LCPUFA, is not optimal.      Intervention: The study is an intervention study, consisting of four groups: DHA, iron,     DHA+iron, and placebo (60 subjects/group = 240 subjects in total). Capsule containing 100mg/d     DHA or its placebo and syrup containing 16mg/d iron will be given daily for 24 weeks. Before     and after the intervention child cognition (as Bayley Mental Developmental Index or MDI     score), serum PUFA level, iron status (haemoglobin, transferrin receptor, ferritin),     inflammation status (CRP, AGP), gene expression profiles, and potential confounders of child     cognition such as lengt-for-age, weight-for-length, and weight-for-age Z-scores,     stimulation/home environment, maternal characteristics will be collected.      Study outcome: The primary study outcomes will be cognitive score (as Bayley Mental     Developmental Index or MDI score) and gene expression profiles. Secondary study outcomes will     be serum PUFA level, iron status (haemoglobin, TfR, ferritin).      Nature and extent of the burden and risks benefit and group relatedness:      Subjects, who will be included into the study will invest 14 hours. The consumption of iron     is not associated with any increased risk of iron overload both for infectious (including     malaria) and chronic diseases nor consumption of n-3 fatty acids EPA and DHA exceed the US     Food and Drug Administrator (FDA) Generally Recognized as Save (GRAS) limit. Venous blood of     5 mL will be drawn at baseline and endline. During screening, children with severe anaemia     (Hb<70g/L) will be excluded from the study and referred to the local public health center for     further treatment.   "
136001|NCT01504620|"     The goal of this single-center, comparative, open label, in-vitro diagnostic device     performance evaluation was to investigate the performance of two sanofi-aventis BGMSs     (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence     (Helios).   "
136002|NCT01504607|"     Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is     reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs     following cataract surgery. However, no data is available regarding endothelial changes after     cataract surgery with IOL implantation in pediatric eyes.      The aim of this study is to prospectively observe changes in endothelial cell density,     coefficient of variation and hexagonality following cataract surgery with IOL implantation in     pediatric eyes.   "
136048|NCT01503996|"     The purpose of this study is to examine if a chronic dehydration is a risk factor for the     developement or progression of some forms of glaucoma.   "
136003|NCT01504594|"     The purpose of this study is to determine whether an autologous stem cell infusion through     catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.      Process:        1. Primary Evaluation             -  Clinical History             -  Echocardiogram to evaluate ejection fraction and other parameters        2. Signing of Informed Consent and clearing doubts        3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony          Stimulating Factor) applied subcutaneously        4. On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by          hematologists through posterior iliac crests(amount calculated at 8cc/kg, without          exceeding 150ml).        5. Recovery room with family members while the cells are being processed in the Hematology          Laboratory.        6. Approximately 3 hours after the 1st procedure, the patient re-enters the operation room,          which is equipped for cardiac catheterization, so that cardiologists infuse the stem          cells through the femoral artery into the coronary arteries which irrigate the heart´s          muscle fibers.        7. Patient goes back to the recovery area until the anesthesia effect is gone and can          tolerate oral liquids.        8. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.   "
136004|NCT01504581|"     Study design:      This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4     groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of     HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a     single dose of a currently marketed PEG-interferon.   "
136005|NCT01504568|"     The purpose of the research is to perform a quality assurance evaluation using randomized     prospective analysis the rate of orbital cellulitis as a complication of nonsurgical orbital     blowout fracture in patients treated versus not treated with prophylactic antibiotics.      The investigators goal is to show the use of prophylactic antibiotics in orbital blowout     fractures does not significantly decrease the rate of orbital cellulitis and is thus not     indicated.   "
136086|NCT01503502|"     It is an open-label, randomized, multi-center study. The efficacy and safety of two     flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400     mg once daily in newly diagnosed (within 6 months) patients with Philadelphia     chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).   "
137334|NCT01487135|"     The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and     supratherapeutic concentrations on cardiac repolarization in healthy subjects.   "
136006|NCT01504555|"     Background: The evaluation for hypercortisolism includes an overnight 1mg dexamethasone (DXM)     suppression test. An important shortcoming is the diagnostic specificity of only 80%, which     is likely due to inter-individual differences in gut absorption or metabolism of DXM.      Study hypothesis: The investigators hypothesize that serum-DXM measurements will increase the     diagnostic accuracy of the overnight DXM-test in the work-up of hypercortisolism.      Aims: The primary aim of this prospective study is to evaluate if serum-DXM measured     simultaneously with serum-cortisol in morning samples could increase the diagnostic accuracy     this diagnostic test. There are several secondary aims. One is to estimate the prevalence and     causes of unusual DXM absorption or metabolism. The investigators will also evaluate the     feasibility and diagnostic accuracy of salivary DXM. Moreover, the diagnostic accuracy of     midnight salivary cortisol and cortisone, and urinary cortisol, will be evaluated and     compared.      Design: Levels of DXM in morning serum following an overnight DXM-test will be analyzed in     patients under evaluation for hypercortisolism (including incidentalomas). A cut-off level to     identify inadequate DXM concentrations in serum to suppress endogenous cortisol production     will be established based on the negative tests. This cut-off level will then be applied in a     retrospective analysis of the diagnostic accuracy of DXM-tests. This prospective study has a     blinded design as the DXM measurements are disclosed after the end of the trial.   "
136007|NCT01504542|"     This study will enroll patients with locally advanced or metastatic non-EGFR mutated     Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more than     two prior approved treatment regimens. Patients will be randomized to receive one of two     doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and     patients will also receive erlotinib 150mg taken orally once daily for the duration of the     trial. The study will examine the immune effects, safety and efficacy of two different doses     of HS110 vaccine in combination with erlotinib versus erlotinib alone.   "
136008|NCT01504529|"     This is an observational, non-interventional and retrospective study in patients with     advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians     according to usual clinical practice in Spain.      The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients     who have been treated with Rotigotine for at least 6 months.   "
136009|NCT01504516|"     This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single     dose, crossover, oral bioequivalence study.   "
136010|NCT01504503|"     This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single     dose, crossover, oral bioequivalence study.   "
136011|NCT01504490|"     This study is for patients with advanced solid tumors. The purpose of this study is to test     the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in     patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer cells,     including stopping cancer cells from growing and dividing, and causing the cancer cells to     die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs together     may have an even greater effect against cancer cells, hopefully, increasing the killing of     cancer cells.      CS-7017 is an investigational or experimental anti-cancer agent that has not yet been     approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene     is an anti-cancer agent that has been approved by the FDA for patients with a specific type     of cancer, cutaneous T-cell lymphoma.      This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene,     has on cancer. This research is being done because it is not known if CS-7017 is safe to be     given with Bexarotene.   "
136012|NCT01504477|"     Panitumumab plus bortezomib for colon cancer   "
136013|NCT01504464|"     Osteoarthritis of the knee is one of the most common causes of disability among elderly. As     the disease progresses the cartilage become frustrated, surrounding bone react to become     thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in     signal density. Patients are treated initially by pain management. In patients who don't     response to first line treatment invasive treatment like total knee replacement is done. The     investigators designed this clinical study with the aim of evaluating therapeutic effects of     intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in patients with     severe knee osteoarthritis.   "
147652|NCT01351584|"     The registry aims to collect and analyse information on the antineoplastic treatment of     breast cancer in daily routine practice of office-based and clinic-based medical oncologists     in Germany.   "
136018|NCT01504399|"     This is a prospective, multi-center observational study designed to address patient-reported     nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary     tumors. The primary objective of this study is to determine the difference in nasal outcomes     by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic     surgical technique and those treated with microscopic surgical technique. Patients will be     given the ASK Nasal survey to assess their nasal functioning and overall health before their     surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.   "
136019|NCT01504386|"     The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane     (TAP) block as a part of a multimodal postoperative pain management after robot-assisted     laparoscopic hysterecomy.   "
136026|NCT01504295|"     It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly     beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in     Europe for acute and chronic alcohol intoxication but has never been tested in the US.     Furthermore, MTDX is used in Europe to treat ALD. Preliminary evidence shows that MTDX     reduces alcohol consumption in AD individuals. If the role of MTDX in reducing alcohol     consumption and improve liver function is confirmed by a rigorous study design, then MTDX     might represent a truly innovative pharmacotherapy for AD, given the potential to be used for     AD individuals with ALD. However until this proposal, MTDX has never been investigated as a     treatment for AD able to reduce both alcohol consumption and improve alcohol-related liver     damage via a double-blind placebo-controlled study. This project therefore proposes to     conduct a 12-week (followed by a 3-month follow-up), double-blind, placebo-controlled,     between-subject randomized clinical trial with MTDX (500mg t.i.d.) in AD individuals.   "
136027|NCT01504282|"     To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during     photorefractive keratectomy (PRK) for patients with low myopia.   "
136020|NCT01504373|"     Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical     ventilation. This mode of ventilation is currently in routine use in adult, pediatric and     neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle     used during inspiration, is measured. The ventilator triggers (synchronizes patient effort)     and applies proportional assistance based on measured electrical activity of the diaphragm     (Edi). This electrical activity is measured through a feeding tube that also has a     multiple-array esophageal electrode in it. This mode of ventilation has been proven to be     equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control     offered by NAVA may not only trigger faster and synchronize better, but provide the support     deemed appropriate by the central nervous center on demand. Traditionally in the intensive     care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is     set to achieve a given tidal volume. The influence of changing lung compliance not only from     the lung disease itself, but the interactions of the respiratory muscles can drastically     change minute ventilation and contribute to hyper- or hypoventilation. These changes are     typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen     saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the     central nervous system to control the ventilator. NAVA may allow us to couple the central     nervous system (neuro-coupling) with the ventilator to provide real-time proportional     assistance, reduce work of breathing and apply physiologic breathing patterns.   "
136021|NCT01504360|"     Development of sarcoma within or adjacent to radiation field is a well known event of poor     prognosis and unknown risk factors. Advanced techniques of radiation therapy including     intensity modulated radiation therapy, tomotherapy or Arc therapy are providing new     modalities of radiation delivery that could be responsible for developing these induced     tumors. There is little data on molecular biology of radiation induced sarcoma even if some     tools are still available to characterize these types of tumors aiming to compare their     profile to a sarcoma observed in non irradiated area. An update of the GETO-GCSF registry,     currently called CONTICANET data base in the framework of EORTC, represents the backbone of     the project. The next step should follow two axes, a clinical one based on the dosimetric     analysis of the characteristics of delivered radiation therapy and the second one based on a     molecular characterization of the sarcomas developed in irradiated field.The data base will     be updated and organized through the CONTICANET network and the radiation oncologists     involved in the treatment of soft tissue sarcoma. A retrospective analysis of the clinical     data and the parameters describing the initial treatment will be registered using the     methodology proposed by I. Diallo for radiation induced tumors developed in childhood. The     most recent data will be extracted in DICOM format for intercomparison in a dedicated     software.A centralized review of pathological specimens is planned to validate the correct     classification of the tumors inside the current staging system developed for soft tissue     sarcoma.   "
136022|NCT01504347|"     Section 1:      The purpose of the study is to obtain safety and immunogenicity data of different dose levels     of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without     adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the     basis for dose/formulation selection for Section 2 of the study.      Section 2:      An additional purpose of the study is to evaluate the safety and immunogenicity of the     optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative     and seropositive healthy subjects aged 18 to 70 years.   "
136023|NCT01504334|"     Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of lung disease     characterized by fibrosis of the supporting framework (interstitium) of the lungs. By     definition, the term is used only when the cause of the pulmonary fibrosis is unknown     (idiopathic). Microscopically, lung tissue from patients shows a characteristic set of     histologic/pathologic features known as usual interstitial pneumonia (UIP). UIP is therefore     the pathologic counterpart of IPF.Idiopathic pulmonary fibrosis is characterized by     radiographically evident interstitial infiltrates predominantly affecting the lung bases and     by progressive dyspnea and worsening of pulmonary function. No therapy has been clearly shown     to prolong survival. The current strict definition of idiopathic pulmonary fibrosis provides     a new focus for basic and clinical research that will improve insight into the pathogenesis     of this disorder and stimulate the development of novel therapies.      Pirfenidone has proven antifibrotic and anti-inflammatory properties in various in vitro     systems and animal models of pulmonary fibrosis, although its precise mechanism of action     remains unclear. It attenuates fibroblast proliferation, production of fibrosis-associated     proteins and cytokines, and the increased biosynthesis and accumulation of extracellular     matrix in response to cytokines such as transforming growth factor-β. It is also shown to     slow tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor     and platelet-derived growth factor.      Pirfenidone has not been widely approved for clinical use in China, in this study, safety and     efficacy were evaluated to see if pirfenidone has a significant advantage over placebo in     terms of improving lung function and life quality etc. (see primary and secondary criteria)     or slows down the deterioration of lung function in Chinese subjects diagnosed with IPF.   "
136024|NCT01504321|"     Polycystic ovary syndrome affects a striking 9-18% of Australian reproductive aged women and     has been associated with a number of metabolic abnormalities.      Given the strong correlation between metabolic abnormalities and increased sympathetic     activity, we hypothesise that reducing this activity using medication (moxonidine) can help     improve the metabolic abnormalities, and therefore improve outcomes in polycystic ovary     syndrome.   "
136025|NCT01504308|"     The purpose of this clinical study is to determine whether treatment with the Philips     Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is     effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).   "
136049|NCT01503983|"     The objective of the study is assess the efficacy and safety of Trastuzumab in combination     with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic     gastric cancer or gastro-esophageal junction, (HER2)-positive.   "
136028|NCT01504256|"     The purpose of this study is to determine the efficacy of catumaxomab by determination of the     rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one     cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy.   "
136087|NCT01503489|"     The present study aimed at identifying clinical risk factors for switch into (hypo)mania or     mixed states, within 8 weeks after introduction of an antidepressant or after increasing its     dosage.   "
136109|NCT01503203|"     The purpose of this study will be assess the effectiveness of the physical virtual training     on nonspecific chronic low back pain, body balance, functional autonomy and mood of older     women. Two groups will be formed. One will do strength exercises and core training. The other     group will do the same exercises more virtual activities with Nintendo Wii. Will be measure     pre and post-intervention of the responses already shown above.   "
136029|NCT01504243|"     CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively     expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a     critical mediator of inflammatory response in the context of sepsis. This study was designed     to investigate whether CD163 genomic variations were associated with the prognosis of sepsis.     We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR sequencing. When     analyzing the results of sequencing, we found five gene polymorphisms located in     exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap database, one     polymorphisms located in exon-2 is non-synonymous variation rs3210140, two polymorphisms     located in exon-5 are synonymous variations rs4883264 and rs4883263, the last two located in     exon-11 are synonymous variations rs61729512 and rs150018775 . Five common polymorphisms     (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with severe sepsis     and in 200 healthy control subjects. This study was explored that whether or not     polymorphisms detected within the CD163 gene may play a major role in the predisposition to     prognosis of sepsis in a Chinese Han cohort.   "
136030|NCT01504230|"     Osteoporosis is a prevalent health concern among older adults and is associated with an     increased risk of falls that can cause fracture, injury and even mortality. Identifying the     factors related to falls occur within this population is essential for the development of     effective regimes for fall prevention. The long-term objectives of this work are to ascertain     the mechanisms for effectively controlling balance in seniors with osteoporosis and to     provide a basis for developing fall prevention programs. The entire body's center of mass     (CoM) is a critical indicator for balance control and the coordination among joints and     muscles to control the CoM is still unclear. The aim1 of this study is to develop     biomechanical models that control the entire body's center of mass (CoM) during upright quiet     stance in seniors with osteoporosis. The aim2 of this study is to identify the mechanism to     control the entire body's CoM after receiving a balance perturbation in seniors with     osteoporosis. The findings of this research can provide needed information regarding the     processes of balance control in this vulnerable osteoporosis population, and has the     potential to be applied to individuals with other neuromuscular and orthopedic deficits.   "
136031|NCT01504217|"     Falling among older adults is a major public health concern. In fact, falls are the leading     cause of accidental death in older adults both in Taiwan and in the United States. In order     to provide effective preventative strategies, the investigators must understand the     mechanisms that cause older adults to fall. Thus, the investigators research aim for three     objectives: (1) using biomechanical model to identify the deficits in neuromuscular control     for older adults (2) to apply research findings to the development of new clinical methods     for assessing and recovering balance control in older adults, and (3) to predict fall risks     in 1-2 year for older adults from the research findings.   "
136032|NCT01504204|"     The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel     in patients with mild to moderate acne who receive a medication sample and instructions on     proper application with their stock size medication tube versus patients who receive only the     stock size medication tube.   "
136033|NCT01504191|"     The overall aim and primary objective is to evaluate the effects on level of depression and     anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a     myocardial infarction (MI).   "
136034|NCT01504178|"     Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations     that could be, in part, due to a central modification of nociception mechanisms. Previous     studies have shown that pain perception was altered in Parkinson's disease (subjective and     objective pain thresholds and pain-induced cerebral activity) and that administration of     L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in     dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain     threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be     involved in pain alteration in PD.      To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine     (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that     duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients     with PD.      36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine     increase the pain perception level compare to the placebo. This increase would be the same     than those observed with L-Dopa.   "
136035|NCT01504165|"     This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose,     Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects     with different grades of renal impairment as compared to subjects with normal renal function.   "
136050|NCT01503970|"     The purpose of this study is to assess safety and efficacy of autologous chondrocyte     implantation delivered arthroscopically into chondral lesions of the knee using clinical,     biochemical, and MRI outcomes.   "
136051|NCT01503957|"     The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of     persistent allergic rhinitis when applied before allergen challenge.   "
136036|NCT01504152|"     The purpose of this study is to survey patients who underwent hematopoietic stem cell     transplant (HSCT) to assess if they have traveled or not internationally after transplant.     This information will help to improve the understanding of the needs for travel health     strategies and interventions to provide healthy and safe travel to HSCT patients. The     findings of this survey will also be used to develop travel health related interventions for     patients living with cancer as well.   "
136037|NCT01504139|"     The purpose of this study is to investigate levels of progesterone in the luteal phase after     various stimulations in the follicular phase and treatment with GnRH antagonist protocol     followed by GnRHagonist as induction of ovulation.   "
136038|NCT01504126|"     The goal of this clinical research study is to learn if it is feasible to give a beta-blocker     such as Inderal (propranolol hydrochloride) with standard chemotherapy (paclitaxel and     carboplatin or possibly docetaxel) to treat ovarian cancer. The safety of propranolol     hydrochloride will also be studied.      Propranolol hydrochloride is designed to block certain chemicals that affect the heart.     Researchers want to learn if this might also boost the immune system, allowing the     chemotherapy to be more effective.      Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.      Carboplatin is designed to interfere with the growth of cancer cells by stopping cell     division, which may cause the cells to die.   "
136040|NCT01504100|"     Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The     efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been     reported good outcomes in most patients. However, some studies reported less effective in     patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q     angle. The investigators hypothesized that femoral internal rotation is a negative factor to     the patellar taping. The investigators enroll consecutive 100 patients with anterior knee     pain and radiographic evidence of patellar subluxation. The investigators determine femoral     rotation via physical examination. The visual analogue scale was evaluate to compare the     result between the those with and without femoral internal rotation.   "
136041|NCT01504087|"     Venous thromboembolism (VTE) is one of the major public health problems in Western country.     More than 100,000 Americans die each year from VTE. VTE is also a common complication of     critical illness,1-2 and probably related to poor outcome in this patient group. Although     there are guidelines about VTE prophylaxis in acutely ill medical patients and patients in     medical ICU3, they are overlooked in our daily practice frequently in our country. There are     many reasons for our common practice, including inadequate knowledge for the ICU physicians,     more patients with bleeding tendency in ICU and low prevalence of VTE in our (eastern)     country. However, the true prevalence of VTE in ICU and if thromboprophylaxis still needed in     certain high risk patients are not unknown. Besides, if there is a difference in the VTE rate     between western and eastern patients, what is the underlying mechanism? The major objective     of this application is to answer the first part of the problem, i.e. to delineate the scope     of this problem.      The specific aims of this application are as follows:        -  prevalence of venous thromboembolism in ICU in Taiwan        -  specific risk in subgroups of ICU patients        -  prevalence and risk factors for silent pulmonary embolism   "
136042|NCT01504074|"     Purpose: To evaluate morphological and functional characteristics of Irvine Gass syndrome      Methods: 30 patients suffering on Cystoid macular edema (CME) secondary to Cataract surgery     will be observed and evaluated by fluorescein-angiography, SD-OCT, reading performance,     contrast sensitivity and microperimetry in a fixed time schedule   "
136043|NCT01504061|"     This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of     Mederma N&I to Mederma Ultra Gel on the appearance of post-surgical scars.   "
136044|NCT01504048|"     The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye     spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due     to chronic watery diarrhea.   "
136045|NCT01504035|"     The goal of this study was to test the efficacy of local analgesic (lidocaine) loaded     hemostatic putty in reducing donor site pain following the harvest of pelvic bone grafts. In     14 patients undergoing harvest of a pelvic bone graft during foot surgery, the bone defect at     the pelvis was either filled with a lidocaine loaded hemostatic putty (Orthostat-L) or the     same putty without lidocaine (Orthostat, currently marketed as Hemabsorb). Postoperatively,     foot pain was eliminated with a peripheral nerve block, while pelvis pain was quantified with     two commonly used pain rating scales (VAS and Wong Baker). Blood samples were collected at     regular time intervals to measure lidocaine levels. Patients which received the lidocaine     loaded putty experienced significantly less pain during the first 12 hours after surgery as     compared to those patients who received the lidocaine deficient putty. Blood lidocaine levels     always stayed below the toxic threshold.   "
136046|NCT01504022|"     The WISH-trial is an open-label, parallel-group, randomized controlled trial. The effects of     self-measuring of the blood pressure at home and the use of a pro-active web-based feedback     system on the blood pressure, number of antihypertensive drugs used, and surrogate     cardiovascular markers during a 12 month period will be investigated.   "
136047|NCT01504009|"     Patients with neuropathic diseases are experiencing increasing muscle weakness, loss of     muscle strength and functional abilities during their illness. In healthy people, regular     exercise is the best way to maintain or improve muscle strength, endurance and general health     status and thereby maintain functioning abilities. Previously, patients with neuromuscular     diseases were advised to avoid any kind of physical exercise. However, lately a number of     studies have evaluated the effect of training in patients with neuromuscular diseases, and     positive effects on the functional abilities have been found. Based on these findings we want     to investigate the mechanisms leading to development of muscle atrophy and loss of functional     abilities, and to explore the opportunities of reducing muscle wasting and thereby improve     the course of the disease development through strength training.      The main objective is to investigate the effects of strength training on slowing disease     progression and reduce the decline in muscle strength and function in patients with     amyotrophic lateral sclerosis (ALS). In addition, the aim is to carry out detailed studies of     biological processes in muscle tissue in order to unveil mechanisms leading to muscle     atrophy, and to examine effects of a strength training program. The goal is to be able to     incorporate strength training in the treatment program of these patients in order to maintain     muscle strength and function in the individual for as long as possible.      Minimum 10 patients with the disease are included in the study. Through a 12 week period the     patients will participate in strength training 2-3 times per week. Muscles biopsies will be     taken (i) 12 weeks before commencement of strength training program, (ii) at the beginning of     training and (iii) after 12 weeks of strength training. Patients will function as their own     controls. Blood samples will be collected simultaneously in order to follow the development     of the strength training. Furthermore, participants will be assessed through at number of     functional tests and questionnaires evaluating their strength, balance and social/     psychological status.      Subjects are recruited through their association with Odense University Hospital. In the     present study, the participants become part of a social network, while participating in     organized training sessions, and thus have a possibility to make contact with other ALS     patients in the same situation as themselves.   "
136053|NCT01503931|"     The mesolimbic dopaminergic reward system is a key structure underlying addictive behaviour     in alcohol addiction and is under control of prefrontal glutamatergic neurotransmission. The     aim of the present multicenter-study in Berlin, Bonn and Mannheim is to use functional     magnetic resonance imaging (fMRI) in alcohol addiction for endophenotyping in order to study     the relevance of genetic variation, in particular in dopaminergic and glutamatergic genes,     for addiction. The investigators will use a temporal discounting and a cue reactivity     paradigm in alcoholics and healthy controls in order to 1) test the impact of genetic     variation on activation of the mesolimbic system in these populations and to 2) to test their     predictive effects for treatment outcome in alcoholics. The subproject will thus bridge     animal research on genetically determined cue reactivity and human studies in alcoholics.     Furthermore, the investigators will link these results to the measurement of glutamate and     glutamine with magnetic resonance spectroscopy (MRS) in subproject SP14.   "
136107|NCT01503229|"     This phase II trial studies how well abiraterone acetate works in treating patients with     hormone-resistant prostate cancer that has spread from the primary site (place where it     started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
136110|NCT01503190|"     This study plans to learn more about the immune system's response to breast cancer in young     women.   "
136054|NCT01503918|"     The purpose of this study is to determine whether reactivation of latent cytomegalovirus     infection in critically ill patients looked after in the intensive care unit can be     successfully and safely prevented using antiviral agents. Comparison is made between standard     care, and treatment with one of two different antiviral regimens: valaciclovir/aciclovir,     which has a favourable side effect profile but requires high dosage to be effective, and     valganciclovir/ganciclovir, which has more side effects, but has been demonstrated to be     effective in low dosage.      The primary hypothesis is that cytomegalovirus reactivation can be effectively suppressed     with antiviral prophylaxis.   "
136055|NCT01503905|"     The current study is a multicentre, randomized, open (unblended), prospective clinical trial     which is sponsored by the researchers. The trial is designed to compare the effectiveness     between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as     neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to     compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant     chemotherapies. The investigators will randomly assign 600 premenopausal female patients with     operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four     cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of     neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy.     Patients will undergo modified radical mastectomy or breast-conserving surgery after four     cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles),     radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011)     guideline. The follow-up will be ten years after surgeries. The primary aim is to examine     whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin,     and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival     (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced     amenorrhea with outcomes in premenopausal women.   "
136056|NCT01503892|"     This study focuses on the use of Metanx® as the sole treatment for improving and reversing     nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal     study groups enrolled in this randomized double blinded study. The minimum sample size of     enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum     number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or     patients who have been diagnosed with diabetes type II for less than five years are included     in this study. The control group will receive placebo pill twice daily versus the treatment     group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal     nerve fiber densities obtained by skin biopsies taken at the beginning of the study before     any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of     twelve months to re-biopsy. In addition each group will answer three sets of questionnaires     relating to their peripheral neuropathy at initial, three months, twelve month visitations.     If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies     will show an increase in intraepidermal nerve fiber density and an improvement in the     subjective score versus the placebo group.   "
136057|NCT01503879|"     Mechanical ventilation is a therapeutic method used in order to keep gas exchange adequate to     cell metabolism in patients with acute respiratory failure. It is currently proved that,     although on one hand the use of this method keeps gas exchange, on the other hand it promotes     and supports pulmonary inflammatory processes (VILI). A recent study about the effect of     positive end-expiratory pressure (PEEP) on DLCO (diffusing capacity of the lung for carbon     monoxide) in patients undergoing invasive mechanical ventilation has proved that patients     without any evident pulmonary disease (negative medical history, negative chest clinical     examination, normal chest X-ray radiography and normal arterial oxygen tension [PaO2]) after     24 hours of invasive mechanical ventilation show a significant worsening of pulmonary gas     exchange properties. The authors have supposed that this worsening may be caused by an early     alteration of alveolar-capillary membrane caused by mechanical ventilation itself. This     hypothesis finds support in some studies carried out on animal models which founds that     mechanical ventilation, even when low tidal volumes (Vt) are set for a few hours, is able to     induce lung injury (as shown by histologic findings). The most sensitive and specific tools     the investigators can currently rely on for the study of alveolar-capillary membrane are the     measurement of diffusing capacity of the lung for carbon monoxide (DLCO) and the evaluation     of plasmatic levels of pulmonary surfactant protein B (SPB). DLCO is a standard, widely     diffused technique for the evaluation of functional alterations of alveolar-capillary     membrane and it is currently available also for patients undergoing invasive mechanical     ventilation. SBP is produced by type II pneumocytes in the alveoli. An increase of its     plasmatic levels is correlated to a decay of pulmonary gas exchange; SPB thus can be     considered an alveolar-capillary membrane anatomical damage marker.      The primary end-point of this study is to evaluate the changes of anatomical (SPB) and     functional (DLCO) features of alveolar-capillary membrane between the spontaneous breathing     and mechanical ventilation as well as the progressive changes affecting DLCO and SPB over     time during general anaesthesia and mechanical ventilation in patients with otherwise healthy     lung undergoing elective surgery. This in order to check the timing of the observed worsening     of alveolar-capillary membrane function, and to find out if the process is progressive in     time.      The secondary end point is to check if the alterations of functional features of alveolar     membrane (DLCO) are proportionate to the increase of alveolar injury marker (SPB), in order     to understand if the worsening of alveolar-capillary membrane function is to be attributable     to an anatomical damage or to a physiologic change of the ventilation-perfusion matching.   "
136058|NCT01503866|"     The purpose of this study is to determine the absorption and excretion kinetics of     bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and     feces in men following a single oral does or 20 mg of [14C]-bardoxolone methyl.   "
136069|NCT01503723|"     Metabolomics, or metabonomics, is a large-scale approach to monitoring as many as possible of     the compounds involved in cellular processes in a single assay to derive metabolic profiles.     Metabolomics allows for a global assessment of a cellular state within the context of the     immediate environment, taking into account genetic regulation, altered kinetic activity of     enzymes, and changes in metabolic reactions. Metabolomics may be useful for understanding     metabolic imbalances and for diagnosis of human disease. The investigators plan to collect     exhaled breath condensate from patients with acute lung injury. Metabolomic analysis in the     patients may help us to explore some novel biomarkers for the disease diagnosis and outcome     prediction.   "
136071|NCT01503697|"     Technetium-99m NC100692 Injection is under development as a diagnostic radiopharmaceutical     for targeting angiogenesis associated with diseases such as primary and metastatic cancer,     and for targeting active fibrosis in cardiac diseases such as developing heart failure and     developing hypertrophic cardiomyopathy.      A principle goal of imaging is identification of disease processes early in their     development, at times prior to symptoms. In cancer, angiogenesis is essential for a tumour to     exceed approximately 1-2 mm3 in size.As markers of angiogenesis are often expressed early in     the growth of a tumour it is postulated that imaging of angiogenesis can assist in early     diagnosis of cancer, relapse or spread, and monitoring response to therapy.      Technetium-99m NC100692 Injection will be tested on 3 populations of pts:      1.30 patients at high risk For breast cancer 2.30 patients with breast cancer 3.15 patients     with locally advanced breast cancer undergoing treatment.   "
136059|NCT01503853|"     Background:      - The costs of medical care have a major effect on patients during illness and treatment.     Surveys with patients and doctors show that both are interested in discussing the costs of     treatment. But they rarely talk about these issues. Both worry about whether it is     appropriate to discuss financial matters in the clinical setting. They are also concerned     about whether this topic will be an awkward one. Researchers are interested in studying how     people want their doctors to talk to them about the costs of illness and medical care.      Objectives:      - To explore and better understand patients views on whether and how doctors should talk     about the costs of illness and medical care.      Eligibility:      - English- or Spanish-speaking adults (at least 18 years of age) who are covered by health     insurance.      Design:        -  Participants will be asked to take part in a 2 1/2-hour focus group. Ten to 12 people          will come together to discuss their thoughts and opinions.        -  A member of the research team will lead the group discussion. The leader will ask a list          of questions about health care payment issues. Those in the focus group will discuss          these issues.        -  Participants will receive a small cash payment and a light snack.   "
136060|NCT01503840|"     Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate     residual postoperative paralysis but it represents the most simple, inexpensive and     widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered     the gold-standard to avoid PORC (post operative residual curarization).      This clinical trial is conducted to verify the reliability of accelerometer-based     neuromuscular monitoring in order to exclude postoperative residual paralysis which is not     highlighted by this instrument at a TOF-ratio=100%.      The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests     after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100%     allows to evaluate whether the recovery of muscle function is concrete, although the     monitoring device shows a complete decurarization; patients treated with sugammadex should     not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.   "
136061|NCT01503827|"     People with brain metastases from melanoma are offered different treatment options after     local treatment of their brain metastases via surgery or stereotactic irradiation. Depending     on the treating institution and the clinician involved a patient may or may not be offered     whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with     stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain     metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT     on quality of life and brain functions such as memory, speech and concentration. Participants     will be randomised after local treatment of their brain metastases to either WBRT or     observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and     other international sites.   "
136062|NCT01503814|"     The goal of this study is to develop, pilot test, and evaluate a highly simplified but     guideline-based program for cardiovascular management for application in resource-scarce     settings. The study aims to assess the effects of implementing a simple low-cost     cardiovascular management program for high-risk individuals, delivered by primary care     providers (PCPs) or community health workers (CHWs), on the proportion of patients     appropriately treated with diuretics as well as a number of secondary outcomes in     resource-scarce Tibet, China and Haryana India.   "
136063|NCT01503801|"     Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence     will:        1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death        2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay          without increasing adverse effect   "
136064|NCT01503788|"     Dural or lumbar puncture (LP), the passing of a needle into the space of the spinal cord, is     a common procedure in everyday clinical practice. The most common use for LP is to measure     the spinal fluid pressure and sample spinal fluid for laboratory analysis. However, it is     also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia.      A notorious side effect of dural puncture is headache that ranges from mild to debilitating     and may last for several days following the procedure. Among diagnosed patients, 39%     experience at least 1 week of impaired ability to perform activities of daily living. The     likelihood of developing a headache after dural puncture depends on a number of factors. As     fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize the     leak seem to offer the best path to lowering the incidence of headache after diagnostic LP,     the commonest clinical context of dural puncture in medical practice.      Lumbar puncture is a highly stressful event for most patients. As both pain and anxiety cause     adrenergic stimulation, they also cause an increase in ICP. We believe that this mild     increase in ICP, occurring before the puncture as well as during the puncture itself may     exacerbate the pressure difference between the CSF space and the epidural space and so worsen     the CSF leak Furthermore, this excess pressure, although mild, might cause the dural puncture     hole to widen slightly and so further augment the leak and possibly even prolong it.     Furthermore, the very anticipation of pain causes a rise in neurotransmitters that may cause     a sensitization effect and worsen pain. This increase in adrenergic drive as well as the     sensitization to pain can be effectively blunted by the periprocedural use of mild IV     sedation. Benzodiazepines, with their sedative-hypnotic qualities are well suited for this     task.      This study aims to test the effect of mild peri-procedural IV sedation using Midazolam on the     rates of headache after diagnostic LP.      Patients undergoing a diagnostic LP will be randomized into two groups. Group 1 will undergo     the procedure as routinely practiced. Group 2 will be given Midazolam IV 10-5 minutes prior     to the procedure and undergo the same diagnostic procedure. All patients in the study will     remain under observation in the hospital for at least 6 hours.      Patients will be evaluated for headache and specifically for headache. Clinical follow up     will continue for 72 hours by administering a short questionnaire over the telephone.   "
136065|NCT01503775|"     The objective of this study is to evaluate the long term efficacy and safety of the CODMAN     TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or     non-ruptured aneurysms in real-life routine clinical practice.   "
136066|NCT01503762|"     Objective: The purpose of this study is to determine effects of mirror therapy in restoring     hand function in patients with flexor lag following orthopedic injuries.      Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be     measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for     3-week, as well, half an hour conventional rehabilitation after each mirror therapy session.     Patients in the control group will receive the same treatment program, but instead of mirror,     they will directly observe the affected hand. Outcome measures including Total Active Motion     (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be administered     before and after the treatment period and 3 weeks after the final treatment session.   "
136067|NCT01503749|"     The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for     the treatment of patients with advanced liver cirrhosis.   "
136070|NCT01503710|"     The purpose of this study is to determine soluble HJV could be an early diagnosis urinary     biomarker of ischemia/reperfusion injury in post CPB-patients.   "
136073|NCT01503671|"     Background      Heart failure is the final consequence of various heart disease and is also the leading cause     of mortality worldwide. Diastolic dysfunction refers to an abnormality of diastolic     distensibility, filling, or relaxation of the left ventricle. Patients with hypertensive left     ventricular hypertrophy and an echocardiogram showing a normal ejection fraction and abnormal     left ventricular filling can be said to have diastolic dysfunction. If pulmonary edema or     effort dyspnea developed in such a patient. The term diastolic heart failure would be     appropriate.      Pathology leading to diastolic heart failure include: impaired relaxation, increased passive     stiffness, endocardial and pericardial disorders, microvascular flow and neurohormonal     regulation. Among them, the association of pro-inflammatory system and diastolic dysfunction     are already established. The investigators therefore hypothesized that the change of serum     inflammatory markers might be associated with the change of left ventricular diastolic     function and the investigators thus conducted a randomized case-control trial with this     regard.      Method and materials      This is a case-control randomized study. The definition of left ventricular diastolic     function is according to Guideline from the ACC and AHA. The investigators will evaluate left     ventricular diastolic function noninvasively by echocardiography before and after the     intervention. Exclusion criteria include coronary artery disease, significant valvular heart     disease, cardiomyopathy, pericardial disease and renal insufficiency. The investigators would     like to enroll 50 cases and the same numbers of the controls. The inclusion criteria are     subjects who underwent peritoneal dialysis at the investigators hospital for more than 6     months with higher pro-inflammation serum cytokine levels (C-reactive protein > 0.2mg/dL).     Atorvastatin (40mg/day) would be given to those who were allocated to the intervention group.     The investigators will than follow up cardiac diastolic function by echocardiography and also     the change of serum markers. The investigators would also genotype the     inflammation-associated genes and their promoter region and find the association between     genetic polymorphisms and the treatment effects of statins.   "
136074|NCT01503658|"     This study has an open-label, five-period, single-sequence design. The purpose of this study     is as follows;        1. Primary             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter on               the pharmacokinetics/pharmacodynamics of clopidogrel             -  To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of               clopidogrel        2. Secondary             -  To explore the representative biomarkers for the variable               pharmacokinetics/pharmacodynamics of clopidogrel             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter on               the drug-drug interactions between aspirin and clopidogrel             -  To explore the representative biomarkers for the drug-drug interactions between               aspirin and clopidogrel   "
136075|NCT01503645|"     1. Chinese herb nephropathy (CHN), a kind of kidney failure caused by Chinese herbs, may be          related to the a component called aristolochic acid (AA).        2. AA may form AA-DNA adducts and accumulate in the kidney and ureter and cause kidney          failure and/or cancer        3. Different enzymes have been reported to detoxify plant alkaloids or other components.          Genes that regulate the production of these metabolic enzymes may affect the chance of          CHN.        4. By comparing the differences in the polymorphisms of these genes between patient with          CHN and control, we may find the changes that play a significant genetic factors for          CHN.   "
136076|NCT01503632|"     This randomized phase III trial studies compliance to a mercaptopurine treatment intervention     compared to standard of care in younger patients with acute lymphoblastic leukemia in     remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take     their medications as prescribed may help them in taking their medications more consistently     and may improve treatment outcomes.   "
136077|NCT01503619|"     RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in tumor tissue and blood samples from     patients with small cell lung cancer registered on CALGB-140202.   "
136078|NCT01503606|"     The purpose of this study is to compare the neonatal outcome and infant neurologic outcome     whose mother were treated with cefazolin plus clarithromycin for one week or until delivery     after preterm premature rupture of membrane.   "
136079|NCT01503593|"     The study was designed to assess the effectiveness of conservation ridge preservation     (horizontal and vertical dimension) after tooth extraction with and without combination of     bone substitutes based on synthetic (calcium sulfate mixed with phosphate.   "
136080|NCT01503580|"     Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the     etiology of OAB was complicated and unclear in many aspects. In particular, the research     about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic     factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the     aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric     aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to     analyze the differences of cardiac conduction and heart rate variability before and after     tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB     and OAB female patients, and before and after tolterodine treatment.   "
136081|NCT01503567|"     This study is conducted in Africa and Asia. The aim of this study is to evaluate in the     participating countries the orthopaedic status and the degree of arthropathy of severe     haemophilia patients in general.   "
136082|NCT01503554|"     In an effort to improve care coordination and reduce hospital readmissions, Rush University     Medical Center developed the Combined Social Worker and Pharmacist Program, which targets     both the psychosocial and clinical risk factors that can lead to rehospitalization. This     study will evaluate the impact of this program on 30-day same hospital readmission rates and     total cost of care.   "
147790|NCT01349790|"     NewGam is a newly developed human normal immunoglobulin solution for intravenous     administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in     patients with primary immune thrombocytopenia.   "
136084|NCT01503528|"     This study is designed to determine if three different methods for providing postoperative     analgesia following total knee joint arthroplasty affect outcomes. These outcomes include     pain and function for a period of up to 3 months, and specific non-pain outcomes, including     cardiac, respiratory, central nervous system, thromboembolism, infection, nausea and vomiting     and urinary retention.      Economic outcomes will also be examined, including length of hospital stay, direct health     care costs and patient satisfaction.   "
136085|NCT01503515|"     This randomized phase III trial studies how well caspofungin acetate works compared to     fluconazole or voriconazole in preventing fungal infections in patients following donor stem     cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in     preventing fungal infections in patients following donor stem cell transplant. It is not yet     known whether caspofungin acetate is more effective than fluconazole or voriconazole in     preventing fungal infections in patients following donor stem cell transplant.   "
136088|NCT01503476|"     Study Hypothesis:      This study is designed as an integral part of the development of new or improved features or     components of the Bravo® pH Monitoring System and may serve verification and validation     purposes The study population will include a group of healthy volunteers (Group A) and a     group of symptomatic patients with known or suspected gastroesophageal reflux disease (Group     B).      Group A: Healthy volunteers will not undergo invasive procedure. These volunteers may be     asked to carry the capsule and\or Bravo Recorder. These procedures will serve to evaluate     different technical matters such as human interface, ergonomic aspects and communication     performances of the system Group B: Symptomatic patients will undergo invasive procedure,     including Bravo capsule delivery, positioning and attachment. Confirmation of capsule     attachment may be done by endoscopically.      These procedures will serve to evaluate overall system performance in actual clinical setup,     for instance: Bravo Recorder performance including communication quality, human interface and     similar, ergonomics of delivery device, pH Capsule performance, etc.      Subjects from both study groups as well as physician may be asked to provide feedback on the     procedure and/or document their activities during the procedure.   "
136089|NCT01503463|"     The purpose of this study is to evaluate whether telemonitoring of patients with chronic     heart failure produces a reduction in the combined end point of all cause mortality and     number of hospitalisations, and whether it improves health related quality of life. In     addition, the trials evaluate the economic and organisational impact of the telemonitoring     service and examine its acceptability by patients and health professionals.   "
136090|NCT01503450|"     The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5     mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse     events and ensure safety of subjects.   "
136091|NCT01503437|"     The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5     mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse     events and ensure safety of subjects.   "
136092|NCT01503424|"     The purpose of this study is to compare the bioequivalence and characterize the profile of     the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects     under fed conditions and to monitor the adverse events and ensure the safety of the subjects.   "
136093|NCT01503411|"     The primary objective of this clinical trial is to evaluate the performance of the Nvision     Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects     undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training     implications for introducing this new imaging modality.   "
136094|NCT01503398|"     The purpose of this study is to compare the bioequivalence and characterize the profile of     the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects     under fasting conditions and to monitor the adverse events and ensure the safety of the     subjects.   "
136095|NCT01503385|"     Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small cell     lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP)     regimen is one of the most commonly used regimens. However, the prognosis of these patients     is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an important     role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote     chemosensitivity and radiosensitivity of tumor cells in preclinical trials.      This is a single-institution, open-label, randomized phase II trial of celecoxib administered     concurrently with cisplatin, etoposide, and radiation therapy in patients with locally     advanced NSCLC, to determine the feasibility, activity, and toxicity of this combination on     unresectable NSCLC, and further to examine biomarkers to predict response to the treatment.   "
136096|NCT01503372|"     The prognosis of advanced gastric cancer and adenocarcinoma of the gastro-esophageal (GE)     junction is poor. Even with modern chemotherapy the median survival ranges around 8-10     months.      Inhibition of neoangiogenesis seems to be a very promising approach in gastric cancer.      Vascular endothelial growth factor (VEGF) acts as one of the most potent stimulating agents     of angiogenesis, and several strategies targeting the VEGF signaling pathway have been     developed, including anti-VEGF antibodies, soluble receptors binding directly to VEGF ligand,     anti-VEGF receptor (VEGFR) antibodies and VEGFR tyrosine kinase inhibitors. The breakthrough     in the clinical development of anti-angiogenic therapy against colorectal cancer came in 2003     with a large prospective, randomized clinical trial of bevacizumab, a monoclonal antibody     directed against VEGF. Anti-angiogenic therapy has introduced a highly effective, completely     new mode of action in this area and is the new standard of care in advanced colorectal     cancer.      The concept of VEGF inhibition is also very promising in gastric cancer. Bevacizumab was     investigated in combination with irinotecan and cisplatin in a phase-II trial, including 47     patients with gastric and GE-junction carcinoma. Bevacizumab could safely be given and could     improve time to tumor progression by 75% compared to historical controls. Several phase-II     trials confirm the tolerability and promising efficacy of bevacizumab in gastric cancer     (Bevacizumab + Docetaxel/Oxaliplatin; FOLFOX + Bevacizumab; Docetaxel/Cisplatin/Irinotecan +     Bevacizumab). These results were so promising that randomized phase-III trials in the     1st-line and perioperative setting are under way (AVAGAST-trial: Cisplatin /Capecitabine +/-     bevacizumab 1st line ; MAGIC-B-trial : ECX +/- bevacizumab perioperative).      Tyrosin kinase inhibitors which inhibit VEGF receptors and EGFR are also investigated in     gastric cancer with promising efficacy. Pazopanib, an orally available tyrosine kinase     inhibitor, selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, -2     and -3, c-kit and platelet derived growth factor receptor (PDGF-R), which results in     inhibition of angiogenesis in tumors in which these receptors are upregulated. Pazopanib has     the advantage of being an orally available anti-angiogenesis component.      Pazopanib shows promising activity in phase-II trials in renal cell cancer, breast cancer,     soft tissue sarcoma and non small cell lung cancer. A phase-III trial of pazopanib in renal     cell cancer (NCT00334282) is completed and resulted in the approval of Pazopanib for this     disease. A phase-III trial in soft tissue sarcoma (NCT00753688) is currently performed.      In phase-I trials, pazopanib was investigated in combination with FOLFOX and     Capecitabine/Oxaliplatin. FOLFOX could be administered in full dose with 800 mg pazopanib. In     Cape/Ox, capecitabine had to be reduced to 850mg/m² bd.      5-FU- and oxaliplatin-based regimens are one of the established treatment standards for     1st-line therapy in metastatic gastric cancer. The efficacy of 5-FU, leukovorin and     oxaliplatin (FLO) compared to 5-FU, cisplatin could be confirmed in a randomized phase-III     trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO). FLO has a favorable toxicity     profile. In Germany, FLO is a widely used combination for advanced gastric cancer and is a     recommended regimen in the new German S3-guidelines 2011.      The investigators therefore want to examine FLO + pazopanib.   "
136097|NCT01503359|"     The purpose of study is to determine whether dietary supplement sarcosine is effective in     treatment of schizophrenia. The investigators will assess impact of sarcosine on quality of     life and sexual functioning. In this project the investigators will also measure glycine,     sarcosine, BDNF, MMP-9 levels and oxydative stress parameters in blood, brain glutamatergic     metabolism parameters in magnetic resonance spectroscopy and oculomotoric changes in     electrooculography.   "
136098|NCT01503346|"     Appetite loss is a severe and common symptom among late-stage cancer patients, and it causes     great the anxiety for the patient's family. In TCM theory, the investigators call these     patients are in block and repulsion condition. The investigators try to set a study to use     the herbal medicine solution taken in frequent small amounts by cancer patients in late-stage     to improve the appetite loss condition. Through this method, the investigators not only want     to improve the quality of life of cancer patients in late-stage but also set a valuable     treatment.   "
136099|NCT01503333|"     The purpose of this school-based trial is to test the efficacy of an intervention to increase     moderate to vigorous physical activity (MVPA) among middle school girls. The 17-week Girls     on the Move (GOTM) intervention has 3 components. Two individual-level components occurring     during school hours include: (1) two face-to-face motivational, individually tailored     counseling sessions with a school nurse, and (2) an interactive Internet-based session during     which each girl receives motivational, individually tailored feedback messages (at 9 weeks).     A group-level component, 90-minute Physical Activity (PA) Club provides an important venue     after school that includes activities to assist girls in establishing a behavioral pattern of     MVPA. The control condition will complete data collection activities and receive their usual     school offerings.      The investigators hypothesize that immediately post-intervention, minutes of MVPA will be     greater by 16 min./wk. in the intervention than control group; At 9 months post-intervention     follow-up, minutes of MVPA will be greater in the intervention than control group; and     immediately post-intervention and 9-mo. post-intervention follow-up, cardiovascular (CV)     fitness will be higher and body mass index (BMI) and percent body fat will be lower in the     intervention than control group.   "
136108|NCT01503216|"     The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured     by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively,     and by total 25(OH)D.   "
136122|NCT01503034|"     This is a non-interventional, retrospective, multicentre study involving women having had a     breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and     non-pregnant women having had a breast cancer between 2000 and 2009 (controls).   "
136100|NCT01503320|"     Acute pancreatitis (AP) is a potentially serious illness characterized by inflammation of the     pancreas with variable involvement of peri-pancreatic tissues and/ or remote organ systems.     AP is hyper catabolic condition due to systemic inflammatory response syndrome (SIRS without     any proven specific treatments. Therefore, current therapy for AP is directed to intensive     medical care, nutrition support and infection control.      Nutritional support is very crucial in the treatment of AP. Enteral nutrition (EN) is the     preferred modality since parenteral nutrition is associated with various complications. EN     could preserve the intestinal permeability, which would be the best barrier for prevention of     certain complications.      Glutamine is the most abundant free amino acid in the body and is used as a major fuel and     nucleotide substrate. When a nutritional deficiency arises in critical illness including SAP,     glutamine tends to be conditionally depleted.      We hypothesize that enteral glutamine supplementation in patients with severe and predicted     severe acute pancreatitis helps in their early recovery and prevention of adverse outcomes.      In this study, we aim to evaluate the therapeutic effect of enteral glutamine on clinical     outcomes, gut permeability, systemic inflammation, oxidative stress and plasma glutamine     levels.   "
136101|NCT01503307|"     The purpose of this research study is to learn about parents' experiences following diagnosis     of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care     clinicians will benefit from an improved understanding of what the diagnosis means to parents     and what they expect concerning the infant, being a parent, and caregiving tasks and     responsibilities. The investigators expect that the knowledge gained will increase     clinicians' ability to respond to parents' needs.   "
136102|NCT01503294|"     Assessment and evaluation of body temperature is an important sign of health and disease.     Inferior thermometry increases the risk of morbidity and mortality, and increases health care     cost by delaying the diagnosis and treatment of fever-related disease. The gold standard for     measuring core body temperature is the pulmonary artery thermistor (PAT). The measurement of     the PAT requires the insertion of the invasive pulmonary artery catheter, a high risk     procedure.      An innovative thermometry technology, the temporal artery thermometer (TAT), has been     introduced into the clinical arena as a potential non-invasive proxy for the PAT. The TAT     reduces the risk and cost of pulmonary artery catheter insertion by non-invasively measuring     core blood temperature by measuring temperature over the skin of the temporal artery.      Research to demonstrate the precision and accuracy of the TAT in normothermic patients has     been published, but little to no data is available in those with temperatures greater than     100.4oF. The purpose of this study is to measure the precision and accuracy of 2standard of     care temperature methods: the thermistor from the PAT, considered the gold standard, and the     TAT as measured in those patients with a PAT temperature greater than 100.4oF.   "
136103|NCT01503281|"     The aim of this study was to compare the effect of a hospital group-based vs. home-based     combined exercise-diet program for the treatment of childhood obesity.   "
136104|NCT01503268|"     Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with     medications, but these are not always effective or tolerated. Ablation is a well-recognised     technique that is recommended for those with symptomatic AF who have failed medical therapy.      Ablation can be performed in a number of ways. In percutaneous ablation, ablation is     performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic     ablation, ablation is performed under general anaesthetic via very small incisions in the     chest wall.      Because AF can be intermittent, the only reliable way to look for it is with long-term ECG     monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).      In this study, the investigators are trying to see if minimally-invasive thoracoscopic     ablation is better than percutaneous ablation, and in turn if they are better than Direct     current cardioversion (DCCV), using ILRs to monitor AF.   "
136105|NCT01503255|"     This study will determine whether a group cognitive-behavioral therapy intervention that     demonstrates preliminary evidence of reducing alcohol use among HIV-infected outpatients in     western Kenya is effective when compared against a group health education intervention in a     large sample over a longer period of time. It will be delivered by paraprofessionals,     individuals with limited formal education and little or no relevant professional experience.     This approach is consistent with successful cost-effective models of service delivery in     resource-limited settings in which paraprofessionals (e.g., clinical officers, traditional     birth attendants and peer counselors) are trained.   "
136142|NCT01502774|"     Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The     investigators recently reported that cyclosporine A, when administered immediately prior to     percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST     Elevation acute Myocardial Infarction) patients. The objective of the present study is to     determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and     seventy two patients with ST elevation MI will be entered into a multicentre, randomized,     placebo-controlled, double-blinded study. They will receive one single injection of     cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion     therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart     failure, left ventricular (LV) remodeling) will be assessed at one year and three years after     treatment.   "
136106|NCT01503242|"     This phase I trial studies the side effects and best dose of yttrium Y 90 anti-CD45     monoclonal antibody BC8 when given together with fludarabine phosphate and total-body     irradiation followed by donor peripheral blood stem cell transplant in treating patients with     multiple myeloma. Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45     monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them     without harming normal cells. Giving chemotherapy drugs, such as fludarabine phosphate, and     total-body irradiation before a donor peripheral blood stem cell transplant helps stop the     growth of cancer cells and helps stop the patient's immune system from rejecting the donor's     stem cells. When the healthy stem cells from a donor are infused into the patient they may     help the patient's bone marrow make stem cells, red blood cells, white blood cells, and     platelets. Sometimes the transplanted cells from a donor can make an immune response against     the body's normal cells. Giving yttrium Y 90 anti-CD45 monoclonal antibody BC8, fludarabine     phosphate, and total-body irradiation before the transplant together with cyclosporine and     mycophenolate mofetil after the transplant may stop this from happening and may be an     effective treatment for multiple myeloma.   "
136111|NCT01503177|"     This phase I clinical trial investigates the side effects and the best dose of local     (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma     (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus     will enable the virus to specifically infect and kill cancer cells and spare, without     damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an     anti-tumor immune response which will result in additional destruction of the tumor by immune     cells   "
136112|NCT01503164|"     Obstructive sleep apnea affects approximately 2-4% of middle-aged adults in the general     population and is associated with several medical conditions including hypertension and     coronary artery. Research over the last decade has shown that obstructive sleep apnea may     also increase the propensity for insulin resistance, glucose intolerance, and type 2 diabetes     mellitus. Positive airway pressure (PAP) is the first line therapy for the treatment of     obstructive sleep apnea. While PAP therapy has several favorable effects such as improvements     in daytime sleepiness and quality of life, it is not clear whether using PAP therapy can     alter metabolic risk. The overall objective of this study is to examine whether treatment of     obstructive sleep apnea with positive airway pressure therapy improves glucose tolerance and     insulin sensitivity. The primary hypothesis of this study is that PAP therapy of obstructive     sleep apnea will improve in insulin sensitivity and glucose metabolism.   "
136113|NCT01503151|"     Adults with Social Phobia will be randomly assigned to either an attention bias modification     treatment, interpretation bias modification treatment, both, or a placebo control condition     not designed to change cognitive bias patterns.      Outcome measures will be social anxiety symptoms and severity as measured by gold standard     questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from     structured clinical interviews based on DSM-IV criteria.      The investigators expect to find significant reduction in social anxiety symptoms in the     Treatment groups relative to the placebo control group. The investigators want to find out     the relative efficacy of attention and interpretation oriented treatments and the combination     of the two.   "
136114|NCT01503138|"     The purpose of this study is to evaluate the efficacy of a purpose-built intervention in     improving the mental health of abused Mainland Chinese immigrant women in a community in Hong     Kong.   "
136115|NCT01503125|"     Giant Axonal Neuropathy (GAN) is a devastating and rare childhood disease. Children with GAN     develop increasing muscle weakness, impaired sensation, and at times mental retardation. GAN     starts in infancy, leads to significant disability, and typically leads to death within the     first 30 years of life. GAN is caused by a defect in the gigaxonin (GAN) gene, resulting in     pathologically enlarged and dysfunctional nerves. Currently, there is no effective therapy.     To find out what medications can help patients with GAN, the investigators have to conduct     clinical trials. In this study, the investigators propose to prepare for future clinical     trials and will invite GAN patients to join our research effort.      The investigators will examine them regularly to better understand their disease. The visits     will include questions, a physical exam, blood drawing, a lumbar puncture, and a skin biopsy.     The visits will also include tests that assess the electrical conductivity of the patients'     nerves as well as a test to measure the patients' brain wave activity. In addition, the     investigators will be performing tests to evaluate the patients' motor function, their     vision, and thinking ability. Identifying an effective GAN treatment is very important     because there is currently none. Clinical trials are the only way to decide whether a new     treatment works in GAN patients or not.      With the future objective of conducting clinical trials in GAN, the proposed project has     three specific aims. The first is to plan for clinical trials by developing reliable outcome     measures, and establishing the infrastructure needed to carry out efficient clinical trials.     The second is to further characterize the patient population from a clinical and molecular     point of view, and the third aim is to utilize the information gathered in this study to     further pre-clinical GAN drug development to select candidate drugs.   "
136166|NCT01502462|"     Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without     significant left-sided valvular or myocardial diseases.      Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.   "
136167|NCT01502449|"     This study will evaluate a telephone-delivered cognitive-behavioral psychotherapy     intervention designed for primary care treatment of combat-exposed service members with PTSD.     The investigators will assess Posttraumatic Stress Disorder (PTSD) symptoms, mental     health-related and occupational functioning, and symptoms of depression, anxiety, and     somatization.   "
136116|NCT01503112|"     Type 2 diabetes is a major and rapidly increasing health problem worldwide. Keeping the blood     glucose (sugar) from going too high helps prevent complications. Recently a number of new     treatments (collectively called 'incretin based' treatments) to lower blood glucose have     become available but response is very variable and it is difficult to predict which will work     for an individual. The investigators want to see if we can identify whether the new     treatments are likely to be effective for an individual patient. Identifying the right     treatment would improve control and minimise the side-effects and costs from ineffective     treatments. We will collect blood (for measures of blood glucose, insulin secretion and     genetics information), urine (for a simple measurement of insulin secretion) and other     clinical information (such as weight,age, duration of diabetes and medication) in people who     are about to start these new 'incretin based' treatments and assess their response over the     first 6 months of treatment. We will analyse this information to see if we can predict     treatment response.      Study Hypothesis:      The investigators hypothesise that those who have low insulin secretion, as measured by post     meal urine C-peptide Creatinine Ratio or blood C-peptide, will have poor blood glucose     response to incretin based treatments.   "
136117|NCT01503099|"     One aims to devise a method for the screening and differentiation of intestinal tuberculosis     and Crohn's Disease. Additionally, one aims to detect and survey multidrug resistant TB.   "
136118|NCT01503086|"     This randomized clinical trial studies how well an adaptive computerized cognitive training     program works compared to a non-adaptive computerized cognitive training program in treating     younger patients with brain tumor who underwent radiation therapy. Providing a computer     training program may improve the well-being and quality of life of patients with cognitive     (physical and mental) function difficulties caused by radiation therapy to the brain.   "
136119|NCT01503073|"     Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a     variety of functions.   "
136120|NCT01503060|"     The aim of this study is to find out the effects of routinely using different types of     pain-relieving strategies during routine immunization injections performed in infants.   "
136121|NCT01503047|"     The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and     t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals     who maintained their normal dietary and exercise patterns.   "
136123|NCT01503021|"     The purpose of the parent study is to assess the short-term safety and tolerability of     soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of     representative adult chronic kidney disease patients on hemodialysis (CKD-HD).      The purpose of the extension study is to assess the long-term safety and tolerability of SFP.   "
136124|NCT01503008|"     The study will test whether the Proteus Sustained Behavior Change (SBC) System will help Type     2 diabetics feel more able to perform self-care activities, feel less distressed about     diabetes, and reduce mean fasting blood glucose levels. The SBC system uses ingestible and     wearable sensing devices and mobile phones to reinforce positive behaviors around medication     usage, exercise and rest.   "
136125|NCT01502995|"     The purpose of this study is to determine whether a laser light beam, attached to a rolling     walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's     disease.   "
136126|NCT01502982|"     The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous     system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients     is feasible and could improve time to treatment failure and reduce the risk of CNS relapses.     Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison     (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course of     high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be     compared to a historical Nordic study.   "
136127|NCT01502969|"     This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety     and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of     Vaccines and Biologicals, Vietnam.   "
136128|NCT01502956|"     The purpose of this randomized, open-label, active-control trial is to compare the     effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral     neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary     incontinence. In addition, the study will evaluate select technical attributes of the     interventions as well as the effect of these two interventions on other lower urinary tract     and pelvic floor symptoms.      Hypothesis: InterStim® therapy will result in a greater reduction in daily urge urinary     incontinence episodes over the 6-month follow-up period as compared to Botox A® injection.      A supplemental study investigates whether biological markers including those related to     inflammation and connective tissue remodeling change following treatments with Botox A® and     Interstim®.   "
136129|NCT01502943|"     The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD) as     examples to build a standard evaluation system for efficacy of traditional Chinese medicine     (TCM).        1. Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes          of CHD and self-administrated scale of Stable Angina Pectoris        2. research on all indicators of CHD, and analyze their characteristics, target and          function        3. theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood and          dissolving stasis as an example for clinical efficacy evaluation.   "
136130|NCT01502930|"     This study is a randomized controlled trial (RCT) to evaluate the effect of an     internet-based, guided self-help treatment of reoccurring and distressing nightmares. Imagery     Rehearsal Therapy (IRT) will be compared to an active control treatment (CONT) and a     recording-only group (REG). It is hypothesized that both active treatments will be superior     to REG, and that IRT will be superior to CONT.   "
136190|NCT01502150|"     The goal of this research study is to collect information on the side effects of proton     therapy and the details of proton treatment plans so that researchers can develop a method to     predict the risk of side effects and to improve the planning and delivery of proton treatment     for patients in the future.   "
136131|NCT01502917|"     The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic     Pontine Glioma (DIPG). The researchers will use convection-enhanced delivery (CED) to     deliver an agent called 124I-8H9. CED is performed during surgery. The study agent is infused     through a small tube placed into the tumor in the brain. Many studies have shown this can     safely be done in animals but this study is the first time 124I-8H9 will be given by CED in     humans. This will be one of the first times that CED has been performed in the brain stem.      8H9 is something called an antibody. Antibodies are made by the body to fight infections and     sometimes cancer. The antibody 8H9 is produced by mice and can attack many kinds of tumors. A     radioactive substance, 124I, is attached to 8H9. 124I-8H9 sticks to parts of tumor cells and     can cause the tumor cells to die from radiation. Studies have also been done on humans using     124I-8H9 to treat other kinds of cancer. Our studies of some DPG and related tumors suggest     that 8H9 will bind to the tumor, but the investigators don't know that for sure.      In this study, the researchers want to find out how safe 124I-8H9 given by CED is at     different dose levels. They will look to see what effects (both good and bad) it has on the     patient. The dose of 124I-8H9 will increase for each new group of patients. The procedure has     already been safely performed with lower doses and infusion volumes in a number of patients     here at MSKCC. The amount they get will depend on when they enter the study. If too many     serious side effects are seen with a certain dose, no one will be treated with a higher dose,     and some more patients may be treated with a lower dose to make sure that dose is safe.   "
136132|NCT01502904|"     There has been little research on neointimal coverage and malapposition after BES     implantation using OCT in human coronary artery. Furthermore, specific drug may possibly     influence the vascular healing after stent implantation. Therefore, this study will     investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation     and 2) relationship of specific drug treatment and neointimal coverage or late malapposition     by the prospective, randomized study.   "
136133|NCT01502891|"     The purpose of this study is to determine whether the Depression Medication Choice decision     aid is effective in involving patients with depression in making deliberate choices when     considering medication treatment.   "
136169|NCT01502423|"     This study will compare injection site pain levels between current Humira® formulation versus     a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either     currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological     naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The     study is being conducted in three countries, Australia (3 sites), Canada (2 sites), and     Germany (2 sites).   "
136134|NCT01502878|"     Nut sensitization in skin prick tests is common in areas, including Finland, where birch     pollen is abundant. However, sensitization to nuts in skin prick test does not predict the     possibility of allergic symptoms when nuts are ingested. In this study the investigators     launch and perform double-blind placebo-controlled nut challenges and oral desensitization/     protocol to those with serious symptoms in the challenge. The efficacy and safety of the new     oral desensitization program is the primary outcome. The effect of oral desensitization on     bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are     secondary outcomes.   "
136135|NCT01502865|"     The overall objective of this project is to conduct a feasibility study using data proved by     Department of Defense National Center for Telehealth and Technology (T2) toward the ultimate     goal of establishing a mechanism by which VA clinicians could access data on Veterans     regarding suicidal thoughts and/or behaviors that occurred when they were on active duty, as     documented in the Department of Defense Suicide Event Report (DoDSER).   "
136136|NCT01502852|"     The purpose of this study is to explore and potentially increase the capacity of the non-VA     community mental health system within the state of Colorado to provide a comprehensive and     coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi     Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF     Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health     issues.   "
136137|NCT01502839|"     The purpose of this study is to examine differences in post-concussive (PC) symptom     endorsement among four groups of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom     (OIF) Veterans: those with a history of target, service-related, mild traumatic brain injury     (mTBI) and co-occurring posttraumatic stress disorder (PTSD) (Group 1); those with a history     of target, service-related, mTBI only (Group 2); those with PTSD only (Group 3); and those     with no history of target, service-related, mTBI or PTSD (Group 4) by examining scores on the     Neurobehavioral Symptom Inventory (NSI). Support for this study is provided by previous     research highlighting the complex relationship between mTBI, PTSD and subsequent PC symptom     endorsement (Brenner et al. 2010; Terrio et al, 2009).      HYPOTHESES ARE AS FOLLOWS:        1. Individuals with a history of target, service-related, mTBI only (Group 2) and          individuals with PTSD only (Group 3) each will report significantly more PC symptoms, as          measured by NSI total scores, when compared to those with no history of service-related          mTBI or PTSD (Group 4).        2. Individuals with co-occurring target, service-related, mTBI history and PTSD (Group 1)          will report significantly more PC symptoms, as measured by total NSI scores, than either          those with target, service-related, mTBI only (Group 2) or those with PTSD only (Group          3).   "
136138|NCT01502826|"     Childhood obesity is increasing at a fast pace, together with its complications. The aim of     the present study is to assess several candidate triggering agents, mechanisms and     intermediate phenotypes of atherosclerosis during the post-prandial phase in the obese     insulin-resistant child/adolescent.   "
136139|NCT01502813|"     The purpose of this study is to determine the functional effects of a citicoline, creatine,     and omega-3 fatty acids combination when administered for a duration of four weeks (28 days)     to non-psychiatric adult female participants.   "
136140|NCT01502800|"     Primary Objective:      To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 761     administered intravenously.      Secondary Objectives:      To determine the pharmacokinetic profile of ARQ 761 To assess the preliminary anti-tumor     activity of aRQ 761   "
136141|NCT01502787|"     The purpose of this study is to determine if Nebivolol a) attenuates the angiotensin II (Ang     II)-induced increase in oxidative stress, thereby attenuating Ang II-induced     vasoconstriction; and b) attenuates sympathetic mediated vasoconstriction during exercise,     thereby reducing functional skeletal muscle ischemia in hypertensive patients.   "
136191|NCT01502137|"     This trial is conducted in Europe. The aim of this trial is to to compare steady-state total     growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy     subjects.   "
136143|NCT01502761|"     Stroke is the second leading cause of death and the leading cause of adult disability     worldwide. This investigation will address the safety and feasibility of directed,     intra-arterial Magnesium measurement and therapy, through endovascular access, in acute     stroke patients. The proposal represents the first study to directly quantify levels of a     systemically administered neuroprotectant in the region of cerebral ischemia. It also     establishes a novel endovascular platform for direct delivery of neuroprotective agents to     ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve     patient care by establishing a novel delivery mechanism for the rescue of threatened brain     parenchyma that can be administered rapidly following acute stroke. If successful, this     selective distribution will allow delivery to at risk tissue in a rapid manner. Salvage of     viable, but threatened, penumbral tissue could afford stroke patients an increased     probability of favorable long term outcome. The investigators hypothesize that endovascular,     intra-arterial, Magnesium administration will deliver high concentration of this     neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic     concentrations. The proposed investigation will evaluate the safety and feasibility of this     novel treatment technique   "
136144|NCT01502748|"     This investigation will address the safety and feasibility of distal, intra-arterial sampling     through endovascular access, in acute stroke patients. Levels of Magnesium will be measured     in the region of infarct in patients who had been treated with intravenous Magnesium therapy     following an acute stroke. This study attempts to address whether the traditional intravenous     means of neuroprotectant administration achieves adequate concentration of the therapeutic     agent in the area of diseased tissue.   "
136145|NCT01502735|"     This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention     of dengue fever.   "
136146|NCT01502722|"     The purpose of this study is to determine if regular soft drinks (with sugar) have the same     effect on thirst as diet soft drinks(with sweeteners).   "
136147|NCT01502709|"     The investigators propose to conduct a randomized blinded placebo-controlled clinical trial     in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either     active treatment (caloric vestibular neurostimulation) or placebo. Data will be collected     prior to and after treatment on thermal and mechanical pain thresholds, clinical signs and     symptoms of TMD, and any adverse events.   "
136148|NCT01502696|"     Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk     for relapse than patients with a non-ulcerated primary and about a 40-50% chance of     developing stage IV disease to which they will almost invariably succumb. In stage I and II     patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be     SN-negative there is still a 25-30% relapse risk.      The purpose of this study is to evaluate the effectiveness and safety when treated with PEG     IFN alfa-2b for 2 years as compared to observation (no treatment), administered after     adequate surgery has been performed for ulcerated primary cutaneous melanomas.   "
136149|NCT01502683|"     One of the most devastating complications of coronary artery bypass surgery (CABG) is     postoperative stroke. While there are multiple causes of stroke after CABG, particles     generated during handling of the aorta is believed to account for most neurologic effects.     Handling of the aorta during CABG occurs several times during the operation. One strategy to     reduce aortic handling is to avoid cardiopulmonary bypass altogether by using off-pump     techniques (OPCAB). Another method is to avoid the use of aortic clamps and/or to use devices     that do not require aortic clamping. This study will test the hypothesis that an off-pump     (OPCAB) approach and devices to perform clampless surgery will result in the least amount of     aortic handling and therefore the lowest incidence and frequency of neurologic adverse     events.   "
136150|NCT01502670|"     This study will look at how the [18]FACBC goes into the lung nodules. This will hopefully     lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is     not approved by the FDA (Food and Drug Administration). This study will help to determine if     it should be approved by the FDA.   "
136151|NCT01502657|"     The purpose of this study is to determine the feasibility and the safety of ultrasound guided     percutaneous dilatational tracheostomy.   "
136152|NCT01502644|"     Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such     as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain     patients (and is termed comorbid negative affect [NA]). The purpose of the study is to     determine whether CLBP patients with either a high vs. a low or moderate degree of NA have     different pain relief responses to oral opioids.   "
136153|NCT01502631|"     The purpose of this research study is to gather scientific information about the     effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive     substance) in subjects with acute spinal cord injury.   "
136154|NCT01502618|"     This study involves conducting formative research to develop a culturally appropriate     secondary prevention intervention for HIV-positive Black young men who have sex with men     (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT).     The formative research includes reviewing data and findings from relevant ATN protocols     (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of     color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus     groups with up to 32 HIV- positive B-YMSM.   "
136155|NCT01502605|"     This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA)     (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this     study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.      Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the     tumor can look like normal brain tissue. Studies in other countries have shown that in some     brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may     make it easier for doctors to remove as much tumor as safely as possible from your brain.      This study also hopes to see if 5-ALA can find different cell populations within the tumor     that is removed and allow the researchers to better understand brain tumors.      The purpose of this study is to:        -  Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see          how well 5-ALA can find different cell populations within brain tumors        -  Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow          under ultraviolet light        -  Make sure the 5-ALA identifies tumor and not normal brain        -  Make sure 5-ALA does not cause any side effects   "
136156|NCT01502592|"     This study is being done to evaluate the safety of two strategies called cryoablation and     immune therapy in women with curable early stage breast cancer. Cryoablation is a     procedure performed by an expert doctor called a radiologist. The radiologist uses (magnetic     resonance imaging (MRI) to insert a needle directly into a cancer. Very cold temperatures are     then applied through the needle to kill the cancer cells. Some of the killed cancer cells     will be broken into pieces that can be recognized by a person's immune system.      The immune therapy in this study is a drug called ipilimumab. Normally the immune system     makes T cells that can kill cancer cells when turned on. The cancer-killing T cell activity     is controlled by a molecule called CTLA4. Ipilimumab works by turning off CTLA4. Turning off     CTLA4 allows the cancer-fighting T cells to remain active Ipilimumab is an antibody drug has     been made in a laboratory for patient use and was recently approved by the United States Food     and Drug Administration (FDA) for the treatment of patients with a type of skin cancer called     melanoma. An antibody is a normal protein that the immune system uses to find and kill germs     like bacteria and viruses. This study is being done because the researchers believe that when     cryoablation is combined with immune therapy, a person's immune system can be trained to     recognize that person's cancer. This may prevent that cancer from coming back in the future.     In other words, it is hoped that by adding cryoablation with ipilimumab before the     mastectomy, the body will remain cancer free long after the mastectomy is performed. The     first step in determining whether cryoablation and immune therapy can be used to cure breast     cancer is to evaluate the safety of each strategy alone and then in combination in a small     group of patients.   "
136157|NCT01502579|"     The pathological variants of IgA nephropathy identified by the Oxford classification may be     related to the clinical data at presentation and follow-up, including proteinuria and renal     function. This study is aimed to identify the potential relationship between pathological     variants and clinical data in IgA nephropathy.   "
136170|NCT01502410|"     This phase II trial studies how well sorafenib tosylate works in treating younger patients     with relapsed or refractory rhabdomyosarcoma, Wilms tumor, liver cancer, or thyroid cancer.     Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.   "
136158|NCT01502566|"     Objective:      The aim of this study is to assess the effectiveness of an oral health educative intervention     in preventing early childhood caries (ECC).      Methods:      The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil.     Twenty-four public health centres (clusters) were randomly selected and assigned to     intervention or control group (12 clusters per intervention group). In each center, up to 30     children/mothers were selected and invited to participate in the trial. Each mother was     interviewed in order to collect socio-economic and demographic variables. The intervention     group received by means of a pamphlet the oral health instructions, which were emphasized     with verbal instructions. Dental examination will be carried out after 1 year for all teeth     surfaces to determine caries status.   "
136159|NCT01502553|"     The clinical protocol of the clinical testing of this device:        1. Objective of the test: To verify the function of device.        2. Test methods and procedures: Performance test in two positions: Seated and Supine.        3. DUT: Transtek Blood Pressure Monitor, Model: LS-802. Cuff size: 22-32 cm and 22-42 cm.        4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and          range: 0-300 mmHg.        5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.        6. Statistical methodology used: Description of statistical methods.        7. Result: Meet the requirements of SP10.   "
136160|NCT01502540|"     Craniotomies are generally thought to be less painful than other operations. Indeed recent     studies have confirmed that pain is a common problem during the postoperative phase following     craniotomy.Pain not only causes discomfort, but it is also associated with other potential     adverse events such as increased sympathetic activity and elevated systemic blood pressure.     These events in turn may contribute to increased intracranial pressure. Some patients may     also develop chronic pain.Potent opioids have been avoided due to its potential to cause     respiratory depression and risk of masking pupillary signs. As a result postoperative     craniotomy pain controls are usually inadequate.      In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no     definite guidelines for postoperative pain management in these patents due to lack of     information about quality of postoperative pain control after craniotomy.      Objectives      Primary objective :      - To study incidence of moderate to severe pain during first 48 hours after craniotomy.      Secondary objectives :        -  To determine risk factors for moderate to severe pain during first 48 hours after          craniotomy        -  To evaluate side effects and complications of postoperative craniotomy pain control        -  To compare patient's expectation for pain management before and after surgery        -  To determine patient's satisfaction for postoperative pain management   "
136161|NCT01502527|"     Based on previous data published on the SERM properties of Femarelle, the investigators     hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA)     symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA     symptoms in symptomatic post-menopausal women.   "
136162|NCT01502514|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients with Heart Disease          as assessed by a series of measurements indicating improvement, stability, or          degradation of a patient's cardiovascular function and exercise capacity?   "
136163|NCT01502501|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients with Heart Disease          as assessed by a series of measurements indicating improvement, stability, or          degradation of a patient's cardiovascular function and exercise capacity?   "
136164|NCT01502488|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients with Autism.   "
136165|NCT01502475|"     In this protocol, the investigators proposed to assess the Complementary Alternative Medicine     (CAM) usage patterns in a Veteran population using a CAM survey developed by Dr. Hernandez     and colleagues. This survey, the Complementary, Alternative and Conventional Medicines     Attitudes Scale (CACMAS), is a brief, self-report questionnaire that assesses medical use     patterns, as well as attitudes about medical treatment and the relationship among these. The     CACMAS will assess the potential role of individual beliefs and attitudes towards     complementary and conventional medicine usage patterns, and possibly indicate how this scale     might be used to predict optimal treatment offerings for a particular population given     attitudes about medical treatments.   "
136168|NCT01502436|"     The purpose of this study is to explore the relationship between attempted and/or completed     suicide and reported experience of chronic pain among an adult veteran population. Specific     aims include a) examining the experience of chronic pain between patients who have either     attempted and/or completed suicide, non-suicide attempt mental health patients, and     non-mental health chronic pain patients and b) determining possible differences in reported     experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity,     occupation, and patient's recorded perceptions of depression and/or quality of life. As     articulated in the Amendment approved on June 13, 2008, additional areas of interest include     histories of neurological disease (e.g. traumatic brain injury) and/or mental health     diagnoses. History of both neurologic disease and mental health diagnoses will also be     identified by chart review (per approval obtained June 13, 2008). As such this study will     also compare differences (e.g., mental health, neurological disease) between veterans who     have history of a suicide attempt, completion, or a lifetime history of suicidality and     matched control veterans without a history of suicide attempts, completions, or lifetime     history of suicide. The relationship between suicidal behavior, attempted/completed suicide,     and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran population     is also of interest. Additionally, this data set will be used to complete a validation study     regarding the Self-Directed Violence Classification System (SDVCS). Specifically, relevant     information in subject chart notes regarding self-directed violence (SDV) will be used to     categorize thoughts and behaviors according to the SDVCS.   "
136171|NCT01502397|"     The purpose of this study is to determine whether preemptive nucleoside analogue therapy or     regular virologic monitoring is the preferred method in management patients with prior     exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.   "
136172|NCT01502384|"     This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's     Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for     PD. The purpose of this study is to explore the association between genetic mutations in the     known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and     cognitive functions.   "
136173|NCT01502371|"     The primary objective of this study is to demonstrate the dose-related efficacy, by     evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent     predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of     three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler     (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive,     with persistent asthma. The primary hypothesis of this study is that at least one dose of MF     MDI BID increases lung function, defined as a significant increase in percent predicted FEV1,     when compared to Placebo.   "
136174|NCT01502358|"     The purpose of this study is to determine whether a new investigational dengue vaccine is     safe, well-tolerated, and to see if an immune response against dengue disease will be     generated.   "
136175|NCT01502345|"     The purpose of this study is:      • To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and     pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device      Secondary:      • To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and     pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when     administered with the TDS-IM electroporation.   "
136176|NCT01502332|"     The purpose of this study was to evaluate prospectively the impact of two protective     mechanical ventilation strategies, both using low tidal volume ventilation (6 mL/kg/ibw)     after cardiac surgery. The study selected patients presenting signals of deficient gas     exchange (PaO2/FIO2 < 250 at a PEEP [positive end expiratory pressure] of 5 cmH2O) in the     immediate post-operative period. An aggressive alveolar recruitment protocol applying opening     pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to the     standard alveolar recruitment protocol of the institution, where an opening pressure of 20     cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing     period of four hours of controlled mechanical ventilation, the patients followed the routine     weaning protocol and physiotherapy protocol of the institution.   "
136177|NCT01502319|"     The Consortium's overall mission can be summarized as follows; each function is developed     with the goal of clear military relevance:        1. Produce new scientific knowledge about suicidal behavior in the military that improves          mental health outcomes for the investigators men and women in uniform.        2. Use high quality research methods and analyses to address problems in policy and          practice that have a direct impact on suicide-related and other mental health outcomes          for military personnel.        3. Disseminate Consortium knowledge, information, and findings through a variety of methods          appropriate for decision makers, practitioners, and others who are accountable for          ensuring the mental health of military personnel. This includes the rapid response          function so that queries from decision makers and others to the Consortium are answered          with speed and efficiency. Technical assistance and support for decision makers and          others is an integral aspect of this Consortium function. This aspect of the Consortium          will warehouse knowledge about suicidal behavior in general (e.g., from civilian and          international sources as well as from military sources), so that military issues can be          informed in a comprehensive manner.        4. Train future leaders in military suicide research through experience within a          multi-disciplinary setting for Ph.D. students and postdoctoral scholars interested in          research questions on military suicide of both a basic and applied nature.   "
136178|NCT01502306|"     California Smokers' Helpline will conduct a randomized trial to evaluate 3 strategies of     services and/or incentives on smoking cessation rates. This project has the following     specific aims:        1. To increase tobacco cessation among Medi-Cal beneficiaries who currently smoke, and to          improve the management of diabetes and other chronic disease by means of tobacco          cessation.        2. Demonstrate that tobacco cessation benefits that are well promoted and barrier free and          include modest incentives, are effective in reducing smoking prevalence, lowering          Medi-Cal health care costs, and improving health outcomes for diabetes management in          particular.   "
136179|NCT01502293|"     This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12     DNA injection (pIL-12) with electroporation (EP) in malignant melanoma. Intratumoral pIL-12     EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor     to initiate and/or enhance anti-tumor immunity.   "
136180|NCT01502280|"     Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat.     Mounting evidence suggests that survival improves with greater tumor removal, yet being able     do a complete removal can be difficult due to the tumor's infiltrating nature.     5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3     hours before surgery, is selectively taken up by glioma cells and causes a red/pink     fluorescence (glow) under a blue light that allows tumor margins to be seen during the course     of surgery. While this compound is used as a standard-of-care agent in Europe, it remains     under testing by the Food and Drug Administration (FDA). A recent clinical trial in Germany,     however, has demonstrated a significant improvement in the rate of complete resection for     certain brain tumors (65% vs. 34%).      The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on     the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special     microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the     tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the     special microscope during surgery will greatly lower the amount of tumor left behind.   "
136181|NCT01502267|"     The purpose of this study is to determine whether high dose IVIG and B cell depleting agents     can be used effectively in highly sensitized wait-listed patients.   "
136182|NCT01502254|"     The purpose of this study is to test if cancer patients who are informed about, and offered     participation in a cancer clinical trial, are more knowledgeable about cancer clinical trials     if they have access to an audio recording of their information visit.   "
136183|NCT01502241|"     The study aims to optimize the treatment of elderly subjects (> 65) with anaplastic     astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative.     There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is     the treatment most likely to be accepted apart from supportive and palliative measures. The     role of chemotherapy is barely defined. Study data available to date does not suggest that     this patient population would benefit from combined radiochemotherapy. The aim of the study     is to verify the hypothesis that first-line chemotherapy with one week on/one week off     temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of     anaplastic astrocytoma and glioblastoma in the elderly (> 65 age group). The primary endpoint     is median survival, as life expectancy is limited to several months. Secondary endpoints are     response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free     survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic     prognostic or predictive markers, and quality of life. Theoretically, it should be possible     to preserve quality of life in the first-line chemotherapy arm of the study.   "
136184|NCT01502228|"     Given the growing importance of anti-angiogenic therapies in the treatment of metastatic     renal carcinoma, it is expected that this trial will establish the preliminary data needed to     apply for funding of a larger clinical investigation of the potential role of PET perfusion     imaging in management of renal carcinoma, and potentially other cancers.   "
136185|NCT01502215|"     Blood transfusion during perioperative period in patients undergoing to major surgery has     been associated to several postoperative complications. Particularly in oncologic surgery,     red blood cell transfusion has been investigated as a factor of worse outcome and cancer     recurrence due to postoperative impairment of cellular immunity. Although red blood cell     transfusion has decreased in worldwide clinical practice, this issue still remains a matter     of controversy in oncologic surgery. There are no prospective studies comparing outcomes     between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study     is a prospective and randomized study comparing clinical outcomes between two strategies of     transfusion in oncologic surgery - liberal or restrictive   "
136186|NCT01502202|"     Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle improve     the efficacy of Pemetrexed/platinum regimen given as first-line treatment for never-smokers     with advanced (stage IIIB/IV) lung adenocarcinoma.   "
136187|NCT01502189|"     The aim of this study is to explore whether an intensified informational intervention built     upon the Representational approach framework can reduce stress in parents of children with     cancer.   "
136188|NCT01502176|"     Retrospective observational study of patients with atrial fibrillation admitted to Roskilde     University Hospital in 2010.   "
136189|NCT01502163|"     Although several measures for prevention of perioperative hypothermia have been introduced     the last decades, perioperative hypothermia is still a frequent complication and associated     with a negative outcome.      For not long lasting surgery without specific risk for hypothermia the standard procedure for     prevention of perioperative hypothermia is insulation. However, the insulation is often not     effective enough to prevent intra- and postoperative hypothermia. The implementation of a     prewarming is difficult because of variable OR schedules and therefore not often applied.      In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a     convective prewarming system on prevention of intra- and perioperative hypothermia     (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced     air warming with or without passive insulation before induction of anesthesia.      The studied prewarming device is easy to use and will be applied on the nursery ward 30-60     minutes before transfer of the patient to the OR.      Perioperative hypothermia is a common complication in general aesthesia. Perioperative     hypothermia is associated with medical risks as intraoperative impaired coagulation due to     reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood     loss. In the postoperative course the perioperative hypothermia is especially for patients     with cardiopulmonary diseases a relevant problem. Not at least sensual cold and shivering is     uncomfortable for the patient.      The study is conducted as a multicenter, prospective, randomised controlled trial. All     patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air     ™). For one intervention group will additionally the insulation with the Thermoflect™ will be     applied on nursery ward, the second intervention group will receive additionally a convective     air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)     preoperatively on study day on nursery ward.      The aim of the study is to prove the hypothesis that a preoperative insulation with a     commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower     incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that     an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated     with a more less incidence of periopative hypothermia.   "
136193|NCT01502111|"     An international airway management expert group has recently developed an Utstein-style     template for uniform reporting of data from prehospital advanced airway management.     Implementing and validating the template will result in a high quality dataset and allow for     research cooperation and comparison of airway management practice between EMS systems, and     across different patient populations. Such a dataset will hopefully contribute to new     knowledge in the field of prehospital advanced airway management.   "
136194|NCT01502098|"     The study aims to establish whether one month postoperative immobilization compared early     passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double     row technique has any healing significance.   "
136195|NCT01502085|"     Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can     be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple     myeloma.   "
136196|NCT01502072|"     The goal of this clinical research study is to learn if ribavirin can help to control RSV in     patients with immune systems that have been weakened by a stem cell transplant. Researchers     also want to compare the effectiveness of the drug when it is given by mouth to when it is     inhaled. The safety of the drug in both methods of delivery will be studied.      Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.   "
136197|NCT01502059|"     This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of     Pilates to treat low back pain.      Hypothesis - the Pilates group will have best results than the control group (usual     medicament treatment).   "
136233|NCT01501591|"     The total effect of a medication is the sum of its drug effect, placebo effect (meaning     response of placebo), and their possible interaction. Current interpretation of the results     of clinical trials (the gold standard in evidence based medicine) assumes no such     interaction. Using a novel cross-over balanced placebo design and caffeine as a model drug,     the investigators have recently shown that a negative interaction does exist; suggesting that     the size of drug effect as currently measured by clinical trials may not be accurate. Due to     the novelty of the findings and their important clinical practice and research implications,     they need to be confirmed using another drug; and the size of drug effect measured using the     novel design need to be directly compared to that measured using conventional clinical trial     design. The results of the study are expected to further our understanding of a widely used     medical intervention, i.e., placebo, and help assess the appropriateness of randomized     clinical trials in determining the size of drug effect.   "
136198|NCT01502046|"     Huntington's disease (HD) is a progressive neurodegenerative disorder, related to an abnormal     expansion of CAG triplets in the huntingtin gene, characterized by motor, cognitive and     behavioral abnormalities, without known effective symptomatic treatment and without known     disease slowing strategy. The most severe neuropathological lesions observed in HD take place     in the striatum, one brain area important in motor control and rich in cannabinoid receptors     (CBR). CBR are subdivided in two classes: CB1R are located in neurons and play a role in     neuronal function; CB2R in brain are located mostly in microglia and modulate     neuroinflammation.      CBR disappear early in the course of HD, before there is a massive drop out of cells in the     striatum. Cannabinoid transmission is also an early event in brains of animal models of HD.     In R6/2 mice, which carry large CAG expansions and develop an early and severe HD phenotype     the suppression of the CB1R gene further accelerate the development of a severe clinical     syndrome and the characteristic brain inclusions and abnormalities of synaptic density. R6/2     treated mice treated with cannabinoids improve their clinical phenotype, their brain lesions,     the synaptic density and the levels of BNDF, a neurotrophic factor which enhances survival     and resistance of striatal neurons.      Preliminary studies of cannabinoids in patients with HD have shown that these compounds are     safe in these patients. Those studies, however, did not show efficacy because 1) they were     underpowered from the statistical point of view, 2) were performed with isolated pure     cannabinoids, instead of the more physiological stimulation with a mixture of compounds, and     3) they did use insensitive clinical parameters instead of sensitive end points, such as     pathogenically important biomarkers.      The investigators propose a phase II trial with combination of cannabinoids with evaluation     of safety, by the profile of adverse events, and efficacy, according to changes of important     biomarkers   "
136199|NCT01502033|"     This research study aims to test the safety and effectiveness of repetitive transcranial     magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how     rTMS treatment affects the neurobiology of teens with depression.   "
136200|NCT01502020|"     Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic     keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week     treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod     cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of     clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding     scalp.      The current clinical study is designed to evaluate the therapeutic equivalence of this     formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation     (Graceway Pharmaceuticals LLC).   "
136201|NCT01502007|"     The goal of the study is to determine if a Fitbit, a kind of accelerometer, provides feedback     to subjects combined with an activity counseling program will result in an increase in     physical activity of at least 20%.   "
136202|NCT01501994|"     The purpose of the study is to determine if providing physicians with a walking workstation,     exercise counseling, and accelerometer feedback about activity will increase physician     activity.   "
136203|NCT01501981|"     In this pilot, investigator-initiated multi-centre, multinational, observational study the     investigators would like to examine the impact of therapy optimization on the level of     biomarkers in patients with acute decompensated and decompensated chronic heart failure.      The primary objective is to determine the best time point for measuring biomarker levels     during therapy optimization in patients with decompensation to predict clinical outcomes such     as mortality, hospitalisation, and quality of life.      Secondary objectives are:        1. To evaluate the impact of guideline-recommended medication on biomarker levels during          and following recompensation.        2. To evaluate whether the trajectory of relevant biomarkers (MR-proANP, MR-proADM) is of          relevance to guide medical therapy following decompensation.        3. To evaluate whether the degree of biomarker change (e.g. slow versus rapid change) is of          relevance with regard to hemodynamic stability and cardiovascular events such as          hospitalisation.        4. To evaluate whether the trajectory of relevant biomarkers (copeptin, CT-pro-ET1) is of          relevance to guide medical therapy following decompensation.   "
136204|NCT01501968|"     Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.   "
136205|NCT01501955|"     The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip     Prosthesis (MHP) compared to the Stanmore hip replacement.   "
136206|NCT01501942|"     This is a Phase II, double-blind, placebo-controlled, cross-over trial to evaluate the     efficacy of AIM-102 for the treatment of allergen-induced asthma. Individuals with stable,     mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a     history of episodic wheeze and shortness of breath, will be eligible for enrollment.      The patients will receive 4 consecutive days of dosing of AIM-102 or placebo (inactive     product) with an allergen challenge on day 3 of dosing to see how the patient's lung function     is changed by using AIM-102 or placebo.   "
136207|NCT01501929|"     The purpose of this study is to determine if Nebivolol improves microvascular perfusion in     skeletal muscle during exercise in hypertensive patients and whether this improvement is     accompanied by reduction in vascular oxidative stress or increased endothelial nitric oxide     synthase (eNOS) expression in humans.   "
136208|NCT01501916|"     The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used     to reduce atherosclerotic risk factors.   "
136209|NCT01501903|"     Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth     in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of     cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple     attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of     the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails     to sample the cancer cells. The fanning technique is a method where the needle moves in     multiple directions within a mass and therefore there is a better chance of the cancer cells     being sampled compared to the standard technique where the needle moves in only one     direction. The diagnostic performance of both these techniques has not been compared in a     randomized fashion.   "
136210|NCT01501890|"     The purpose of this study is to investigate whether treatment with progesterone for patients     with first trimester vaginal bleeding will alter the rates of obstetrical complications and     adverse pregnancy outcomes.   "
136211|NCT01501877|"     This study is designed to develop and test a smoking cessation intervention for smokers with     Type 2 diabetes.   "
136212|NCT01501864|"     The purpose of this study is to test whether school support can keep adolescent Kenyan     orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.   "
136213|NCT01501851|"     Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and     Thickness   "
136214|NCT01501838|"     The purpose of this study is to create a registry of patients with Pulmonary Hypertension who     received medical care in the Hospital Italiano of Buenos Aires.   "
136215|NCT01501825|"     The Multiway stimulator is a novel TMS stimulator with several new and unique properties.     Currently standard TMS devices include a single channel, and can operate only a single coil.     The Multiway stimulator includes five channels which can operate up to five independent TMS     coils, either simultaneously or sequentially.      The Multiway device may be used to obtain a differential activation of various brain regions.     For instance it can be used to induce high frequency stimulation of a certain brain region,     thus inducing facilitation, while simultaneously stimulate at low frequency in another brain     region, leading to inhibition.      The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in     comparison to a single channel DTMS treatment in subjects with MDD.      Subjects will be treated with one of two designs of the study device (the Multiway Coil TMS     Device):        1. Single Channel with a coil placed over the left PFC (10 Hz).        2. Four channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. c. 10 Hz over the          left parietal cortex. d. 1 Hz over the right parietal cortex.   "
136216|NCT01501812|"     Learning includes the ability to generalize to new situations and respond to similar, yet not     identical stimuli. In previous work, focused on stimulus generalization in healthy     volunteers, tones that were negatively reinforced induce wider generalization curves than     tones that were positively reinforced, and these in turn induce wider curves than neutral     memory (Schechtman et al, 2010).      The current study aimed to evaluate those patterns in different clinical disorders (including     Schizophrenia, Bipolar disorder, MDD, Anxiety disorders (Panic and GAD) and PTSD, and healthy     subjects that would be used as a control), with consideration whether those patterns are     unique to any specific disorder or state.      The generalization patterns evaluation would conduct twice though enable to compare the     stability of those patterns during the course of the illness (i.e during remission compared     to acute state).      The basic paradigm based on conditioning of a tone (sound) with unpleasant noise, and     extinction of that conditioning afterword. During the 60 minutes of evaluation, the     capability to discriminate between the original tone and similar but not identical tones, and     the tendency to categorize similar tones as identical to the original tone. A neutral tone     without conditioning will be used as reference. The clinical diagnosis will conduct by a     senior psychiatrist, and the state would be evaluated using standard questionnaires   "
136217|NCT01501799|"     EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES,     L.P., is a safe and effective topical therapy used for the treatment of acne vulgaris.     Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene and benzoyl     peroxide topical gel 0.1%/2.5%,and the current study is designed to evaluate the safety and     efficacy of this formulation to determine if it is bioequivalent to EPIDUO™.   "
136218|NCT01501786|"     Normal cardiac and respiratory functions should be maintained during pediatric cardiac     catheterization. Propofol has become a popular choice for sedation in children, however, it     depresses cardiac and respiratory functions. Some investigators reported that ketamine     attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and     respiratory depression caused by propofol in pediatric cardiac catheterization.   "
136219|NCT01501773|"     A multi-centric initiative to study safety,feasibility and efficacy of using intravenous     autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This     phase of study is visualised as phase 2 study and will aim to determine dose response     gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for     autologous stem cell therapy in patient with acute ischamic stroke.   "
136220|NCT01501760|"     Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal     opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to     reduce newascularization induced by gastric cancer or age-related macular degeneration. A few     reports have been published showing the interest of VEGF inhibitors to treat corneal     newvessels, but no randomized study has been achieved to date.      This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal     antibody, to reduce the surface of corneal newvessels in when compared to placebo   "
136229|NCT01501643|"     Acute chest syndrome is a severe respiratory complication of sickle cell disease.      The standard prevention of this dangerous complication is spirometry in wich patient is     required to take deep breaths trough a little device several times a day. This treatment is     compromised when pain in important or when the patient is asleep and cannot participate.      The investigators hypothesised that non invasive ventilation in wich patient have no effort     to take might be a better prevention than spirometry and may improve pain and quality of     sleep.      Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly     assigned with either spirometry or ventilation and the investigators will monitor for     occurrence of acute chest syndrome, pain and quality of sleep.   "
136221|NCT01501747|"     The total effect of a medication is the sum of its drug effect, placebo effect (meaning     response of placebo), and their interaction. Current interpretation of clinical trials (the     gold standard of evidence-based-medicine) assumes no interaction, and the mechanism(s)     underlying such interaction have not been fully explored. One possibility is that the placebo     effect may modulate drug bioavailability. Using caffeine as a model drug, we have recently     shown that the placebo effect of caffeine ingestion prolongs caffeine half life. Due to the     novelty of this finding and its important clinical practice and clinical research     implications, it needs to be confirmed in another set of subjects and extended to additional     drugs.      The results of the study are expected to further our understanding of the mechanism of action     of a widely used medical intervention, i.e., placebo. The results will be important for both     clinical practice and clinical research.   "
136234|NCT01501578|"     This study is an observational and retrospective study of patients with pulmonary fibrosis     associated or not with telomerase mutation.      The purpose of this study is to describe in detail the cases with telomerase mutation in     terms of features on CT scan, respiratory function and evolution, in comparison to control     subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family     history.   "
136235|NCT01501565|"     The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12     and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP)     and patients under conventional analgesia. Also the opioid consumption is assessed.   "
136222|NCT01501734|"     Successful treatment of pulmonary edema was first published in 1938 by A. L. Barach. Since     then, this has been the accepted method of treating acute respiratory failure due to left     heart failure and edema.      The question was raised if pressure supported ventilation during sleep is used to eliminate     sleep apneas, would it be useful also for improving congestive heart failure (CHF). Recent     studies assessed the role of continuous positive airway pressure (CPAP) in patients with     advanced CHF and found the treatment useful. A possible explanation for these results is that     central sleep apnea frequently coexists with severe CHF and is not treated or suppressed by     CPAP.      The frequency of central sleep apnea increases with the severity of CHF and can be found in     more than 30% of patients.      A few recent studies showed the usefulness of bilevel positive airway pressure (BIPAP) or     adaptive servo-ventilation (ASV). ASV led to improvement in ejection fraction as well as in 6     min walking distance testing, and was associated with decreased BNP levels. In another study,     bilevel PAP increased LVEF by 7.9%.      The limitations of these studies are the small number of patients and that they were     conducted on inpatients only. These factors make it difficult to include BIPAP in the     guidelines for chronic heart failure therapy.      Recently, two outpatient modalities have been introduced to diagnose sleep disordering     breathing (SDB). However, no study has directly compared the results of both studies in     patients with CHF. Moreover, no studies have assessed improvement in CHF after BIPAP     treatment.      In addition, the investigators plan to assess the endothelial function in this population     before and after BIPAP treatment with the EndoPAT, a noninvasive technology   "
136223|NCT01501721|"     Objective: This study aimed to characterize the food intake and energy expenditure of school     cooks and to evaluate the anthropometric and metabolic changes that occurred after a     low-volume home-based exercise program.      Methods: A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was     conducted during the school year of 2007. The trial had a factorial design based on two     different interventions: 1) nutritional counseling and 2) home-based exercise. The     nutritional intervention was focused on decreasing the amount of sugar used in school meals     by the cooks as well as decreasing their own sugar intake. The exercise program consisted of     stretching and aerobic exercises that could be practiced at home, at least three times per     week (40 minutes per session), with a low-to-moderate intensity.   "
136224|NCT01501708|"     In this prospective phase II observational study, we plan to assess the efficacy and     tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in     a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched     unrelated donor or mismatched donor conditioning with ATG containing regimen or present     III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.   "
136225|NCT01501695|"     The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric     patients with tic disorders.   "
136226|NCT01501682|"     The purpose of this study is to compare the long-term complaints after ventral hernia repair     after insertion of different types of mesh compared with primary suture. Also recurrence of     hernia will be discussed.   "
136227|NCT01501669|"     This study is a multicenter, randomized study, open-label, phase III study.The efficacy of     irinotecan and capecitabine combination will be superior to capecitabine alone in term of     progression free survival in metastatic breast cancer patients previously treated with     anthracycline and taxane.   "
136228|NCT01501656|"     Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular     events in malignant transformation and is readily detectable in apparently normal benign     breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA     methylation of certain genes occurs as a field change in benign breast tissue that is at high     risk for malignant transformation, and as such, can be exploited for tissue-based breast     cancer risk stratification. Additional work is required to identify new DNA methylation     markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based breast     cancer risk stratification, to determine whether these markers are methylated more frequently     in benign samples from women who develop breast cancer, to determine whether assessment of     these markers is reproducible, to determine whether tamoxifen reduces DNA methylation, and to     better understand the pattern of DNA methylation in benign samples from unselected healthy     control populations. Each of these objectives contributes to advancement of a clinically     useful RP-FNA-based breast cancer risk stratification test.      In addition, identification of genes that are preferentially methylated in estrogen receptor     (ER) negative breast cancer will provide clues to the underlying biology responsible for this     aggressive form of breast cancer. This knowledge may lead to the discovery of the causes of     ER negative breast cancer, approaches for recognizing women at increased risk for this type     of breast cancer, and approaches for reducing this risk.      This study seeks to identify patterns of DNA methylation in benign breast epithelial cells     associated with an increased risk for breast cancer with a focus on ER negative breast     cancer.   "
136230|NCT01501630|"     Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer:     diagnostic performance and impact on the patient management.Determine the lowest cost     strategy according to the precise clinical circumstances.   "
136231|NCT01501617|"     The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the     administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected     intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).   "
136232|NCT01501604|"     In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120     as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase     (PI3K)pathway, thereby inhibiting tumor growth and survival.      The purpose of this study is to learn if the study drug BKM120 can shrink or slow the growth     of your tumor. The safety of BKM120 will also be studied. Your physical state, symptoms,     change in the size of your tumor, and laboratory findings obtained while you are on study     will help the research team decide if BKM120 is safe and effective in patients with advanced     cancers.   "
136236|NCT01501552|"     The overall objective is to study if training and support, financial reimbursement and     referral to an internet based brief intervention programme, singly or in combination, may     increase implementation of evidence based methods of identification and brief intervention     for excessive alcohol consumption in routine primary health care.   "
136237|NCT01501539|"     The primary objective of this study is to compare the incidence of postoperative     hypergranulation tissue formation after gastrostomy tube placement among children randomized     to one of three treatments, in addition to measuring tube dislodgements and rates of resource     utilization for complications.   "
136238|NCT01501526|"     Herpes esophagitis presents a clinical diagnostic challenge. The investigators report the     first case of herpes esophagitis presenting as vocal fold palsy in an immunocompetent host.     The investigators case highlights the importance of performing a detailed laryngoscopic     examination in any patient with prolonged husky voice.   "
136239|NCT01501513|"     The objective of this study is to compare the safety, tolerance and efficacy of BLI800     (approved and investigational regimens) to an approved control preparation as bowel     preparations prior to colonoscopy in adult patients, particularly including the elderly and     those with renal and/or hepatic impairment.   "
136240|NCT01501500|"     The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A     (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by     binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals     and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The     investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by     decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of     hallux valgus treated with total contact insole. The outcome measurement may shed light in     treating patient with painful hallux valgus and document evidence for plantar pressure     changes in acute, sub-acute and chronic stage.   "
136241|NCT01501487|"     Genomics assays that measure specific gene expression patterns in a patient's primary tumor     have become important prognostic tools for breast cancer patients. This study is designed to     test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and     TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict     responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer     (LABC).   "
136242|NCT01501474|"     Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant     Biliary Strictures      Objectives        1. To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant          biliary stricture diagnosis        2. To assess the sensitivity, specificity and accuracy of Fluorescent in situ          Hybridization(FISH) in malignant biliary stricture diagnosis      Study design One academic center, prospective, diagnostic study      Research Methodology Target population: Patients who are diagnosed malignant biliary     stricture. Sample population: Patients who are diagnosed malignant biliary stricture in     Chulalongkorn Hospital   "
136244|NCT01501448|"     The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF     cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to     equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as     good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation     of IVF cycles.   "
136245|NCT01501435|"     To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra   "
136263|NCT01501201|"     The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized     medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of     mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost     utility of these two strategies.   "
136264|NCT01501188|"     The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius muscle     activation during gait and on Range of ankle motion in postmenopausal females with Chronic     Venous Insufficiency in initial stages in comparison to a placebo control group.   "
136246|NCT01501422|"     1. Sex hormone including estrogen have synergistic effect to serotonin activity and          decrease activity of monoamine oxidase activity so the norepinephrine is not be          metabolized, these substance are important to regulate hemostasis and circadian process          of sleep        2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion             -  GABA substance is in order to initiate sleep and continue sleep        3. According to epidemiologic data, problem of sleep was increasing in postmenopause group          compare to premenopause group (aged-match)        4. This research perform to find out the actual effect of estrogen in improving sleep          quality.   "
136247|NCT01501409|"     Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole     surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa and     skin and results in many side effects. This study was to compare the effects of SLS-free     dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis     (RAS).   "
136248|NCT01501396|"     This randomized phase II trial studies the safety and efficacy of megestrol acetate given     with or without mirtazapine in treating cancer patients with weight loss and loss of     appetite. To date, no pharmacologic interventions have been approved by FDA to treat cancer     anorexia-cachexia syndrome (CACS). Megestrol acetate has been shown to increase appetite in     cancer patients. Adding mirtazapine may provide a much more effective treatment and help     improve quality of life.   "
136249|NCT01501383|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of VX-765 in     subjects with treatment-resistant partial epilepsy.   "
136250|NCT01501370|"     Histone deacetylase (HDAC) inhibitors represent a potential new class of antitumor agents.     Vorinostat (suberoylanilide Hydroxamic acid, SAHA) inhibits the activity of all 11 known     human class I and II HDACs. HDACs have many protein targets whose structure and function are     altered by acetylation, including histones and non-histones proteins component of     transcription factors controlling gene expression and proteins that regulate cell     proliferation, migration and death (1). Vorinostat has undergone initial evaluation in     several phase I and II clinical trials in both solid and hematologic malignancies. It has     shown activity in hematologic malignancies including Hodgkin's disease and non Hodgkin's     lymphomas (2-5); it has been approved for treatment of cutaneous manifestation in patients     with primary cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease     on or following two systemic therapies (6). HDAC function is critical for Multiple Myeloma     (MM) cells by actively maintaining a transcriptional program indispensable for their     uncontrolled proliferation and/or inappropriate resistance to pro-apoptotic stimuli. The     pleiotropic anti-MM effects of Vorinostat and its ability to sensitize MM cellsto multiple     conventional or novel agents (7) provide the framework for clinical trials of Vorinostat in     MM. A phase I trial of oral Vorinostat alone in advanced MM shows modest activity, but     treatment was generally well tolerated (common drug related adverse events (AEs) included     fatigue, anorexia, dehydration, diarrhea and nausea and were mostly grade < 2) (8). A phase I     clinical trial of Vorinostat in association with Bortezomib in relapsed MM patients report a     partial response (PR) rate of 42%, with responses occurring also in patients refractory to a     previous Bortezomib based regimen. Treatment was generally well tolerated (main adverse     events were myelosuppression, fatigue and diarrhea) (9). Lenalidomide is an active agent     against MM, that as shown activity in both the relapse and newly diagnosed settings, in     combination with chemotherapy or steroids only. The dose of Lenalidomide commonly used in the     relapse setting, in association with steroids, is 25 mg/day on days 1-21 every 28 days (10,     11). A recent phase I study evaluated the safety and tolerability of Vorinostat in     combination with Lenalidomide and Dexamethasone in relapsed patients:no dose limiting     toxicities prohibited dose escalation, the maximum tolerated dose has not been reached and     the maximum administered dose was Lenalidomide 25 mg/day on days 1-21, Dexamethasone 40     mg/day on days 1,8,15,22, Vorinostat 400 mg/day on days 1-7 and 15-21; each cycle was     repeated every 28 days. Rate of at least PR was 51%, and activity was seen also in patients     who received prior Lenalidomide therapy (clinical benefit reported in 69% of patients,     including minimal response or better in 33% of Lenalidomide refractory patients). The most     common drug related grade > 3 AEs were neutropenia, thrombocytopenia, diarrhea, anemia and     fatigue (12). Since Vorinostat has shown efficacy also in patients previously treated with     Lenalidomide, and in patients refractory to Lenalidomide, the investigators hypothesis is     that the addition of Vorinostat and low-dose dexamethasone to Lenalidomide (ZLd), in patients     experiencing a biochemical relapse during a Lenalidomide maintenance ongoing therapy, can     overcome Lenalidomide-drug resistance and result in a significant response rate, that can     translate into a significant improvement in survival of MM patients. The second hypothesis is     that, since the dose of Lenalidomide commonly administered in maintenance therapy, is 10 mg     days 1-21 every 28 days, the increase in Lenalidomide dose to the standard dose used for     relapsing patients, plus low-dose Dexamethasone (Ld), in patients experiencing a biochemical     relapse during a Lenalidomide ongoing maintenance, can as well overcome Lenalidomide-drug     resistance and determine a significant response rate, that can translate into a significant     improvement in survival of MM patients.      This is a multicenter non comparative, randomized, open label, phase II study. Patients, who     are receiving Lenalidomide maintenance treatment with or without prednisone, will be     randomized to receive:      Cohort 1: ZLd association:      Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Vorinostat orally at     the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle.      Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.      Cohort 2: Ld association:      Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Dexamethasone orally     at the dose of 40 mg day 1,8, 15, 22 every 28 days.      Patients must have a -confirmed diagnosis of relapsed multiple myeloma. In this Phase II     study, a total of up to 35 patients in the ZLd cohort and 48 in the Ld cohort will be     enrolled. It is anticipated that full accrual to this study will take approximately 36     months.   "
136251|NCT01501357|"     The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique     compared with anteroposterior and biofilm removal and control of caries lesions in first     permanent molars.   "
136252|NCT01501344|"     This study will determine if daily oral intake of 200g of a marketed yogurt with fortified     calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in     postmenopausal women. The efficacy of the product is measured by examining the variation of     biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it     has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of     bone tissue have not yet been proven.   "
136253|NCT01501331|"     The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT)     on a daily basis and transmission of data via the Remote Monitoring technology. This may     result in early detection of imminent decompensation at a presymptomatic stage. The study     will assess the respiratory trends correlation with clinically relevant heart failure events.   "
136254|NCT01501318|"     The investigators seek to develop a more efficient and effective approach to providing brief     behavioral health interventions for risky substance use behaviors by comparing a brief coach     directed intervention to a tailored report only group.   "
136255|NCT01501305|"     Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment     in children.   "
136256|NCT01501292|"     Cytoplasmatic maturation is an important event in the general maturation of of the oocyte.     Mitochondria is one of the major organelles involved in the process of cytoplasmatic     maturation. The aim of this study is to investigate the presence and distribution of the     mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro     maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not     undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these     immature oocytes the investigators shall also investigate the mitochondria in mature oocytes     that underwent ICSI but did not become fertilized and are discarded.   "
136257|NCT01501279|"     The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck     and proximal urethra. Pain management during transurethral procedures is a major     concern.Patients who have been catheterized under anesthesia complained of urgency in the     postoperative period because of catheter-related bladder irritation. We want to investigate     that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in     transurethral prostatectomies   "
136258|NCT01501266|"     The purpose of this study is to confirm the safety profile such as the frequency of serious     adverse events or any unexpected adverse events and overall efficacy of Faslodex for long     term treatment in daily clinical practice.   "
136259|NCT01501253|"     The aim of present study is to evaluate the efficacy and safety of two dose combination of     S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy     (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.   "
136260|NCT01501240|"     A prospective intra-individual study to investigate the diagnostic performance of gadoxetic     acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as     standard of reference   "
136261|NCT01501227|"     Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care patients     as they may cause the death of the patient or prolong the intensive care stay or complicate     the illness in other ways. The risk of infection is dependent on the interplay between     bacteria load into the lungs and the immune status. There has been a lot of focus on bacteria     load reduction and this includes the use of subglottic suctioning in an attempt to reduce the     amount of bacteria that may move into the lungs. The Hi Lo tubes which were designed to allow     subglottic suctioning was significantly effective in reducing the incidence of ventilator     associated pneumonia compared to normal tubes. A new generation of endotracheal tubes that     not only incorporate subglottic suctioning but provide a more snug fit into the tracheal by a     new tapering design may be even more useful to provide the solution for bacterial load     reduction. Conventional tubes which may furrow on themselves to allow the creation of     microchannels may aid microaspiration. The taper guard which has facilities for subglottic     suctioning as well as the strategy to reduce furrowing to the minimum may be the answer to     the problem of ventilator associated pneumonia. This study is to determine the extent of     protection this tube has against ventilator associated pneumonia compared with conventional     endotracheal tubes   "
136262|NCT01501214|"     The hypothesis of this randomized double blind study is that the live birth rates are     significantly higher after the use of atosiban prior to the embryo transfer in patients     undergoing in vitro fertilization (IVF) treatment. This study aims to compare the live birth     rates of IVF treatment between patients receiving atosiban and placebo prior to the transfer.   "
136265|NCT01501175|"     To date, the investigators still do not know the annual incidence of Superficial Vein     Thrombosis in the legs, although the investigators do know that this pathology is frequent     and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is     of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with     concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so     it is important to re-evaluate this rate on an unselected population from general practice.   "
136266|NCT01501162|"     Background/Aims:      The investigators explored the therapeutic effects of probiotics in patients with AH.      Methods:      Between September 2010 and April 2012, the investigators conducted a 7-day,     double-controlled, randomized, prospective clinical trial comparing the efficacy of     probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an     aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT)     level with an alcohol consumption history within 48 hours. Patients were randomized to     receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified     Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and     again after therapy.   "
136267|NCT01501149|"     The purpose of this study is to evaluate the efficacy and safety of DDGP regiment     (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer     (NK)/T Cell Lymphoma.   "
136268|NCT01501136|"     The purpose of this study is to evaluate the efficacy and safety of DDGP regiment     (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage     I/II Natural Killer (NK)/T Cell Lymphoma.   "
136279|NCT01500993|"     This study compares capecitabine with standard 5-FU in the perioperative treament of locally     advanced rectal cancer.   "
136280|NCT01500980|"     The purpose of this study is to determine if sterile, protective immunity to malaria can be     induced by malaria parasite exposure limited to the early liver stage of the parasite     lifecycle.   "
136345|NCT01500109|"     The purpose of this investigator-initiated study is to determine whether acetaminophen is an     effective pain reliever for primary cleft palate repair in children and possesses opioid     sparing effects. Additionally, the investigators will determine if patients who receive     acetaminophen have less opioid related side-effects. The study will have three study groups     based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral     acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine)     alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the     intraoperative period and 24 hours after surgery for all patients within the study and     converted to morphine equivalents.   "
136269|NCT01501123|"     PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST)        -  The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the          sedation of agitated patients in the prehospital environment        -  The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1           o The RASS is a well validated standardized score to measure a patient's agitation        -  The secondary outcomes are             -  Time until RASS returns to 0 or 1 if RASS <0             -  Need for additional sedation             -  Adverse effects (need for intubation, arrhythmia)        -  Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying          haloperidol        -  Identification of potential study patients will be per state protocols        -  Exclusion Criteria for the study        -  Age <18        -  Pregnant        -  Allergic to study medication        -  Transport to hospital other than Mercy Fitzgerald Hospital        -  Unable to reach medical command prior to giving medication        -  When a paramedic identifies a possible study candidate, the paramedic will consult          medical command to see if the patient is appropriate for the study        -  If the medical command agrees the patient is appropriate for the study, patients will be          randomized to        -  Odd days: Haloperidol 5mg IM (age <65) or haloperidol 2.5 mg IM (age ≥65)        -  Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age <65) or maximum of 2.5mg (age          ≥65)        -  The RASS will be documented by the prehospital providers every 5 minutes until arrival          at the hospital        -  Once the patient arrives at the ED, the RASS will be documented in PICIS® by the          emergency department nurse at the time of triage and at a minimum of hourly until the          RASS =0 or 1 for 2 consecutive hours        -  Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267)          205-6453      Richmond Agitation Sedation Scale      RASS RASS Description        -  4 Combative, violent, danger to staff        -  3 Pulls or removes tube(s) or catheters; aggressive        -  2 Frequent non-purposeful movement        -  1 Anxious, apprehensive, but not aggressive 0 Alert and calm             -  1 Awakens to voice (eye opening/contact) >10 sec             -  2 Light sedation, briefly awakens to voice (eye opening/contact) <10 sec             -  3 Moderate sedation, movement or eye opening. No eye contact             -  4 Deep sedation, no response to voice, but movement or eye opening to physical               stimulation             -  5 Unarousable, no response to voice or physical stimulation   "
136270|NCT01501110|"     The propose of this study is to determine whether N-acetylcysteine is effective in reversing     the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.   "
136271|NCT01501097|"     The purpose of this study is to determine if early application of CRRT will result in an     improvement of clinical outcomes of burn patients during the early phase of sepsis   "
136272|NCT01501084|"     Obesity is a major health problem in the US and many Western countries, with more than half     of the population being overweight or obese. Yet, despite intense research efforts into the     mechanisms underlying obesity and into the development of novel pharmacologic interventions,     bariatric surgery, including gastric bypass surgery is the only successful treatment for     severe obesity. Mimicking one of the effects of bariatric surgery, e.g. the increased     secretion of glucagon-like peptide 1 (GLP-1) could be an effective strategy against obesity.      Obese individuals may be more sensitive to the rewarding aspects of food and less responsive     to signals from the gut about actual energy needs. Using functional MRI scanning the     investigators plan to examine the effect of Exenatide (a GLP-1 analog known to reduce caloric     intake and produce weight loss in both obese and lean individuals) on activity within brain     regions/networks involved in reward/motivation and in regulation of energy requirements. The     investigators expect the peptide to change the balance between desire to eat for pleasure and     the need to eat to maintain homeostasis.   "
136273|NCT01501071|"     Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic     Nissen fundoplication became the standard surgical treatment of this disease. Although being     almost transient postoperative dysphagia is still a common complaint following this     procedure. The aim of this study is to investigate the effect of inserting a soft structured     and blunt mounted 39 F orogastric tube to postoperative dysphagia.   "
136274|NCT01501058|"     This study aims to develop a parent-assisted social skills training program for adolescents     with autism spectrum disorder(ASD) and verify therapeutic effects of the program through     case-control study.        1. Both the case and the control of this study shall be a high-functioning group consisting          of adolescents aged 11 to 18 years with ASD and an IQ of 80 or over. A total of 40          adolescents will be recruited and divided into two groups of twenty. One will be the          case group and the other will be the waitlist control group. Again, the case will be          divided into two sub-groups of ten and carry out this new developed program for both          parents and adolescents. That is, the program will be carried out two times in each of          both groups. The waitlist control group will be allowed to receive personal outpatient          treatment and general therapeutic intervention from community while waiting.        2. Effects of the program will be measured both at the case and the control by using a          scale which measures social interaction, quality of peer relationship, disposition of          autism and social anxiety. Equal assessments for both the case and the control will be          conducted right before the beginning of the program and right after the completion of          the program and some of the survey will be retried in order to see mid- and long-term          effects three months after the completion of the program.   "
136318|NCT01500486|"     This study is conducted in Europe. The aim of this study is to evaluate ease of injection of     growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience     and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device -     is also evaluated.   "
136275|NCT01501045|"     While some indications of the neural circuits involved in the Conditioned Pain Modulation     (CPM) process are now available, there is still need to clarify what parts of the brain are     essential for this process, whether the spino-brainstem loop is largely sufficient to explain     CPM or whether other cerebral and spinal regions such as frontal, somatosensory and other     cortical regions contribute substantially. Whereas mere observation of correlation between     these circuits while activated by brain imaging is still of considerable interest, direct     experimental manipulations by repetitive transcranial magnetic stimulation (rTMS) could even     establish insights into causal relationships.   "
136276|NCT01501032|"     The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas     system)automated insulin management system using continuous glucose monitoring (CGM) and     subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will     include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus     meal, under-bolus meal and exercise.   "
136277|NCT01501019|"     Exercise may improve physical capacity and health parameters in Primary Syndrome´s Sjogren,     Myositis and Takayasu's Arteritis.      Therefore, this study aims to investigate the role of an exercise training program in     patients with Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.   "
136278|NCT01501006|"     The purpose of the study is to improve patient-physician communication and clinical decisions     in the context of serious illness that may affect important clinical outcomes. The     investigators will examine how variations in communication patterns and clinical decisions     are affected by patient demographics (e.g age, sex), patient interactional style (e.g.     communication behaviors) and physician characteristics (e.g. attitudes, background,     training).   "
136281|NCT01500967|"     Neck pain and related problems occur frequently in modern societies and have a considerable     impact on individuals and the society. Cervical radiculopathy (CR) generally presents with     pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a     nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral     disc herniation. Various studies have shown that nonoperative management for CR is effective,     such as medications, physical therapy, Spinal manipulation, traction, acupuncture, collar     immobilization and epidural steroid injections. Spinal manipulation is one of the manual     techniques for treating mechanical neck pain. No high-quality evidence has proved the     effectiveness of manipulative therapy in the treatment of cervical radiculopathy. However,     limited evidence suggests that manipulation may provide short-term benefit in the treatment     of neck pain, cervicogenic headaches and radicular symptoms. Few complications, such as     worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal massage     manipulation is used for centuries in China. Many patients with cervical disc disease are     increasingly turning to manipulations to alleviate their symptoms and reduce the side effects     of medications. The goal of this study is to determine the efficacy of a spinal manipulation,     three steps and nine manipulations, on treating with the cervical radiculopathy.   "
136282|NCT01500954|"     MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a     variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is     very limited and microarray based genome wide miRNA expression profiles of cSCC have not been     investigated so far.   "
136283|NCT01500941|"     Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and     prevention but their precise role is not yet clear.      The aim of this randomized double blinded active treatment vs placebo study was to evaluate     clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius LS01     and Bifidobacterium breve BR03) for the treatment of adult AD patients.      The rationale for the use of probiotics in the treatment of atopic dermatitis would be due to     some experimental hypotheses:        1. The use of these microbial agents at an early age seems to play an important role in          inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE          mediated        2. the normal intestinal flora (including probiotics) would play an important role in          inducing immunological tolerance        3. the hygiene hypothesis that the reduced bacterial environment would favour a type 2          response T and the development of allergic diseases   "
136284|NCT01500928|"     The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0)     micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for     their treatment.   "
136285|NCT01500915|"     The purpose of this study is to investigate the safety and efficacy of a combined     fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the     treatment of exudative age-related macular degeneration (AMD) in patients with good visual     acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be     achieved with fewer injections, even in patients with good VA.   "
136286|NCT01500902|"     The purpose of this study is to determine if testing patients for endothelial dysfunction     will help identify which patients are more likely at risk to have another heart attack in the     future. Study participants will undergo mental stress testing while at the same time being     connected to a device that measures endothelial function via the Endopat device. These same     participants will also undergo a sleep study via the Watchpat device.   "
136287|NCT01500889|"     The investigators compared conventional lateral internal sphincterotomy (CLIS), V-Y anal     flap, and combined tailored lateral internal sphincterotomy with V-Y anal flap (TLIS with     V-YF) in a randomized prospective study in patients undergoing treatment for chronic anal     fissure.   "
136288|NCT01500876|"     Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning      External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation     therapy      Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment      Primary objectives: To assess pre-treatment global and focal lung strain and correlate with     changes post-treatment   "
136328|NCT01500343|"     The purpose of this study is to evaluate the feasibility, safety and effects in inflammatory     response of the therapy with a probiotic agent, the yeast Saccharomyces boulardii (SB), in     chronic heart failure patients.   "
136289|NCT01500863|"     Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in     women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides     adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS)     still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are     used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.      By testing different luteal support protocols on women undergoing GnRHa triggering, the     investigators aim to find out which protocol resembles the most the gene expression profile     observed after hCG triggering and conventional luteal phase support, in order to choose it as     the most adequate in terms of endometrium receptivity and safety (OHSS incidence).   "
136290|NCT01500850|"     The aim of this study is to observe changes in cardiovascular biomarkers during treatment     with Lantus in patients with Type 2 Diabetes mellitus.   "
136319|NCT01500473|"     Background: Congenital Central Hypoventilation Syndrome (CCHS) is a rare disorder of     automatic control of breathing. This disease can manifest as early as birth. Patients with     this disease have a fundamental lack of central drive breathing. They do not mount any     responses to hypoxia or hypercapnia during sleep or wakefulness. This places them at risk of     injury or death whenever they are not consciously breathing. They require lifelong assisted     ventilation while sleeping, and some while awake. Progesterone is a known respiratory     stimulant in normal individuals, and it has been shown in one study of 2 patients that this     drug may improve CO2 responsiveness in patients with CCHS. However, this observation requires     confirmation.      Hypothesis: Exogenous progesterone (in oral contraception pills) will improve CO2     responsivity by hyperoxic hypercapnic ventilatory response testing, hypoxic responsivity     using 5-breath nitrogen breathing, hyperoxic ventilatory response while breathing 100%     oxygen, and improve spontaneous ventilation during sleep in CCHS females >15-years of age.     The progesterone will also depress ventilatory response using a hyperoxia test.      Study Methodology: Baseline measures of CO2 and oxygen responsivity, and spontaneous     ventilation during sleep, will be performed at baseline and after 3-weeks of taking a     progesterone containing oral contraceptive agent. CO2 responsivity will be measured using a     hyperoxic hypercapnic ventilatory response test. Hypoxic responsivity will be measured using     a 5-breath 100% nitrogen breathing test. Hyperoxic responsivity will be measured by having     subjects breathe 100% oxygen for 2-minutes. Subjects will perform an overnight polysomnogram     to assess adequacy of gas exchange during spontaneous breathing while asleep. A progesterone     containing oral contraception pill will then be given for 3-weeks, and the above measures     repeated. Serum progesterone will be measured at baseline and at the time of study.   "
136346|NCT01500096|"     The purpose of this study is to determine whether American ginseng is effective in the     treatment of HIV-associated fatigue.   "
136291|NCT01500837|"     Background:      One of the leading causes of peri-operative osteoarticular infections (OAI) is Staphylococcus     aureus. Treatment usually requires surgical debridement in association with appropriate     antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is routinely     indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In this     protocol, the latter includes clindamycin in combination with rifampin or levofloxacin.     Clindamycin is considered a good option in staphylococcal infections, because of its action     against biofilm formation and bacterial adherence, its high level of joint and bone     penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances the     elimination of a large number of drugs. Therefore, an influence of rifampin on clindamycin     pharmacokinetics must be considered.      Objectives:      The primary objective is to compare the influence of rifampin and levofloxacin respectively     on the pharmacokinetics of clindamycin in a randomized series of peri-operative     staphylococcal OAI. The investigators then seek to determine the optimal drug association     with regard to infection control and drug tolerance.      Study design:      Monocentric, randomized, open label, comparative study      Study period:      From November 2010 to October 2011.      Materials and Methods:      Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are     randomly assigned either to the clindamycin/rifampin arm either to the     clindamycin/levofloxacin arm, according to the antimicrobial susceptibility testing. Peak     and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of     oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same     intervals to monitor patient compliance.   "
136292|NCT01500824|"     This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East     Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event     involving the ALK gene locus who have received only one prior chemotherapy regimen for     advanced NSCLC and this regimen must have been platinum-based. Primary objective of this     study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary     objectives are to evaluate clinical efficacy including median progression-free survival (PFS)     and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks,     time to response (TTR), and duration of response (DR).   "
136293|NCT01500811|"     Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and     soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There     are treatments available to help manage these symptoms like weight loss, and analgesics.     Surgery is the appropriate treatment in patients who have failed these conservative     treatments. The aim of this clinical study is to assess safety of autologous cultured     chondrocyte intra-articular injection and obtain its clinical results in patients with severe     hip osteoarthritis.   "
136294|NCT01500798|"     This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone     methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less     than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for     evaluation of the primary endpoints.   "
136295|NCT01500785|"     Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary     artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial     dysfunction. It has been suggested that the mechanism responsible for the contractile     depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium.     Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned     myocardium without obvious impairment of diastolic function. Systemic vasodilation and need     of vasoconstrictive medication is usually apparent after administration of levosimendan.     Colucci et al have demonstrated that with intracoronary administration of milrinone, another     inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it     may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by     adding levosimendan into cardioplegia solution.      The investigators hypotize that levosimendan, delivered together with cardioplegia, can     improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic     valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac     output 15 min after separation from cardiopulmonary bypass compared to the baseline.     Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal     closure and cTnT/CK-MB on the first postoperative morning.   "
136296|NCT01500772|"     This study is to evaluate the overall efficacy, and safety profile of the triple combination     therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV)     patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease     inhibitor (PI).   "
136297|NCT01500759|"     Objective target of the registry is to investigate the prevalence of SDB as well as the     clinical characteristics of patients with and without SDB as well as the predominant type of     sdb.      For this purpose data from patients suffering from chronic, symptomatic heart failure with     impaired left ventricular ejection fraction will be collected prospectively.   "
136298|NCT01500746|"     This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts     in chronic wounds.   "
136329|NCT01500330|"     The purpose of this randomized controlled study is to determine the effectiveness of cupping     massage as home use for patients with chronic nonspecific neck pain compared to relaxation     exercise.   "
136340|NCT01500174|"     The objective of the study is to examine the effectiveness of Ultraviolet-C (UVC) for healing     pressure ulcers in people with spinal cord injury. UVC is a form of radiation similar to     sunlight but it is normally absorbed in the earth's atmosphere. Participants will be assigned     by chance to receive placebo-UVC or real UVC treatment, in addition to receiving wound care     according to best practice guidelines. The hypothesis is that UVC-treated wounds will heal at     a faster rate than wounds receiving placebo treatment.      Given that pressure ulcers impact on an individual's quality of life, and generate high costs     to the overall health care system, further work is needed to explore alternative means of     pressure ulcer treatment.   "
136341|NCT01500161|"     The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for     unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also     to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.   "
136342|NCT01500148|"     The purpose of this proof-of-concept study is to assess the relative safety and feasibility     of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.   "
136299|NCT01500733|"     Background:      - Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or     lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood     cells that hurt the immune system and make it more difficult to fight infections. These     cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are     over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL.     They may have other health problems that make chemotherapy difficult. In addition,     individuals who have a genetic abnormality called 17p deletion also do not respond well to     standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug,     PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups.      Objectives:      - To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and     people with 17p deletion.      Eligibility:        -  Individuals over 65 years of age who have CLL/SLL.        -  Individuals at least 18 years of age who have CLL/SLL and 17p deletion.      Design:        -  Participants will be screened with a medical history, physical exam, and imaging          studies. Blood and urine samples will be taken. Optional bone marrow and lymph node          biopsies may also be taken.        -  Participants will take PCI-32765 capsules every day for 28 days (one cycle of          treatment). Treatment will be monitored with frequent blood tests and clinic visits.        -  PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug          will continue to take it as long as there are no side effects and the disease does not          progress. Those who do not benefit will stop treatment and have regular followup exams.   "
136300|NCT01500720|"     Primary Objective:      To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to     topotecan in participants with sensitive or resistant/refractory small cell lung cancer     following a first line platinum based chemotherapy.      Secondary Objectives:        -  To assess disease progression free rate at 12 weeks        -  To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and          duration of response        -  To assess Overall Survival (OS)        -  To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC]          version 4.03)        -  To assess the Health-Related Quality of Life (HRQoL)   "
136301|NCT01500707|"     This study is being done to assess the pharmacokinetics of SCH 900800 in participants with     moderate to severe Parkinson's Disease (PD) being treated with L-DOPA.   "
136302|NCT01500694|"     For subjects in Europe that have already participated in either Study SPD503-315 or     SPD503-316. This is an extension study that will allow participants access to     Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the     sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl     (SPD503).   "
136303|NCT01500681|"     Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is     associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical     relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly     used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance     PLEX) is sometimes used to prevent relapses. This observational registry will record     feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX     for NMO.   "
136304|NCT01500668|"     Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive     drugs such as amines. Finger necrosis (so called blue toe syndrome) is a well documented     phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum     toxin is a known muscle relaxant used for a variety of medical application. Recently, several     reports have demonstrated its effect in vasospastic disorders. It has also been in mice that     when administered locally it has a local vasodilatory effect. The goal of this experiment is     to compare the effect of Botulinum Toxin administered locally on amine induced finger     necrosis.   "
136305|NCT01500655|"     The purpose of this study is to determine whether either a peripheral nerve block under     ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided     block of the nerve followed by continuous catheter infusion of local anesthetic, offers     better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery,     than the current analgesic regimen of subcutaneous local anesthetic infiltration.      Eligible subject, pediatric patients having reconstructive surgery for burns, having skin     graft donor sites of the lateral thighs, will be randomized into three groups: control     (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided     nerve block with catheter placement --fascia iliac.      Post-operative comfort will be assessed over the next 48 hours.   "
136306|NCT01500642|"     The dose and the mode of administration of sublingual therapy remain open questions to     determine the efficacy and safety of this desensitization therapy, the main purpose of this     study is to evaluate if different routes of administration (oral-vestibular vs. sublingual)     and a maximum dose of allergen administered are able to determine a different effect or a     different incidence of side effects of the therapy in a group of patients with     rhinoconjunctivitis and/or asthma due to ragweed   "
136307|NCT01500629|"     The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms of     allergic rhinitis (hayfever). Subjects' participation in the study will last approximately 4     to 6 weeks, and each of three study visits during that time will last a few hours. Subjects     will be required to have several tests done including allergy and breathing tests. They will     be exposed to the item they are allergic to and will have small paper discs put in their     noses. Subjects will also have the inside of their noses examined and will be asked questions     about the level of their allergy symptoms.   "
136308|NCT01500616|"     The purpose of this study is to collect safety and tolerability data on telaprevir treatment     in combination with Peg‑IFN‑alfa and RBV in patients with HIV/genotype 1 chronic HCV     coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment     into an ongoing clinical study of telaprevir.   "
136338|NCT01500200|"     This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to     adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant     therapy.   "
136339|NCT01500187|"     Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that     can occur around the edge of fixed orthodontic brackets.   "
136309|NCT01500603|"     Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have     been presented as efficient treatments for management of stress urinary incontinence (SUI)     following radical prostatectomy (RP), but no comparative study of these two techniques has     been published. The investigators aims were to compare the efficacy of the two devices and     provide data about their cost effectiveness.      Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is     more efficacious than Pro-ACT balloons at one year follow-up.      Primary objective: The primary objective of this study is to compare the efficacy of the     AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after     RP at one year follow-up.      Secondary objectives:        -  Comprehensive comparative medical evaluation of the two devices in terms of efficacy        -  Complete evaluation of the side effects of the two techniques        -  Evaluation of the quality of life        -  Evaluation of patient satisfaction        -  Cost-effectiveness study of the device (total cost over one year of each of the two          techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential          cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be          made for assessing the potential coverage by the French healthcare system) Population:          Patients with history of RP without cancer recurrence, presenting pure SUI on          urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test          < 300g).      Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers),     comparative trial of the two devices (with a superiority hypothesis). The total number of     subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at     1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated     questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report     of any secondary effect). Statistical evaluation is carried out at the end of the follow-up,     in intent to treat.      Medical evaluation:      Main criterion:failure of the treatment, defined by reduction of less than 50% of     incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical     device for SUI.      Secondary outcome criteria        -  pad usage per day        -  quantitative reduction of the 24hr-pad test        -  complications (infection, erosion, hematoma, acute urinary retention)        -  number of re-interventions or re-admissions during follow-up        -  quality of life measured by the ICIQ-SF questionnaire        -  patient satisfaction by the PGI-I questionnaire      Economic evaluation:        -  Study of the total cost over one year in each case        -  Adjustment of cost of each device to quality of life (QALY evaluation)        -  Cost effectiveness study        -  Proposals will be made to state at which level the two devices should be covered by the          healthcare system.   "
136310|NCT01500590|"     Diabetes is the leading cause of chronic kidney disease in developed countries. About 30-40%     of patients with type 1 and type 2 diabetes mellitus will develop diabetic nephropathy.     Microalbuminuria is often used as an early predictor of diabetic nephropathy. Many studies     already demonstrated the renoprotective effect of Renin-angiotensin-system (RAS) blockers in     patients with varying degree of albuminuria, few studies focus on studying the decline in     glomerular filtration rate (GFR) among patients with normoalbuminuria. However a substantial     number of diabetic patients exist with sub-normal GFR without microalbumin excretion. From     literature, diabetes mellitus will have faster decline in GFR but the investigators do not     know whether such decline can be slowed down by the use of RAS blockers as compared with     other anti-hypertensive drugs. This Study investigate the effect of early treatment with RAS     blockers on the decline rate of GFR in diabetic patients with normoalbuminuria.   "
136311|NCT01500577|"     The primary objective of the proposed trial is to assess. The efficacy and the safety of a     daily administration of nimesulide or simvastatin to change the expression of a large set of     tissue and circulating surrogate endpoint biomarkers (SEBs) of breast carcinogenesis in women     at higher risk of developing a hormone non-responsive (ER neg) breast cancer. The primary     endpoint is the change in prevalence of atypical cells and cellular proliferation (Ki-67),     after 12 months of treatment.   "
136312|NCT01500564|"     Previous research that utilises single sessions of transcranial direct current stimulation     (tDCS) have demonstrated functional improvements. However these improvements are usually     short-lived, lasting less than one hour before the patient's performance returns to baseline.     In these studies, tDCS is typically applied with the goal of adaptively enhancing functional     activation of pathologically under-active tissue or suppressing pathologically over-active     tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can     improve learning/memory functions in healthy controls. The goal of this study is to test if     the application of tDCS could enhance learning and/or memory for physiotherapy     rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients     at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions     of tDCS.      This research has important implications; previous studies suggest that such an approach has     the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a     clinically viable rehabilitative tool. Recovery of motor skills may take many months to     acquire and therefore strategies that have the potential to enhance acquisition of skill are     of practical and scientific interest.   "
136313|NCT01500551|"     Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have     previously participated in tofacitinib JIA studies.   "
136314|NCT01500538|"     Vorinostat is a drug (Histone Deacetylase Inhibitor [HDACi]) administered orally that has     been approved in United States for the patients with cutaneous Tcell lymphoma (CTCL) who have     progressive, persistent or recurrent disease on or following two systemic therapies.      In the early period of treatment with vorinostat, some patients may experience low platelet     counts. Therefore this study will be examining the combination of these two medications     (Vorinostat and eltrombopag) to assess if eltrombopag can overcome the low platelets during     treatment with vorinostat.      Eltrombopag is a drug administered orally designed to mimic the protein thrombopoietin, which     causes the body to make more platelets. Eltrombopag has been registered in Australia and     approved overseas to treat patients with chronic ITP (Immune Thrombocytopenia Purpura) a     disease where patients destroy their own platelets very rapidly and thus develop low platelet     count) but it is not registered and it is not yet known whether eltrombopag can increase     platelet counts in patients treated with the HDACi.      The aim of this project is to test whether Vorinostat and eltrombopag can be safely combined,     and to test whether they are effective in participants with T-cell lymphoma involving the     skin or patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma     (MZL), or mantle cell lymphoma (MCL)      A total of 25 people with Cutaneous T cell lymphoma/ CTCL, marginal zone lymphoma, follicular     lymphoma or mantle cell lymphoma will be recruited in this study.   "
136315|NCT01500525|"     Objectives:      Our goal is trying to identify an ideal BDR cutoff point for Chinese controller-naïve     asthmatic children. In order to achieve this, several steps need to taken.        1. To observe BDR distribution curve for Chinese non-asthmatic children from 4-12 years        2. To observe BDR distribution curve for Chinese controller-naïve asthmatic children from          4-12 years        3. To compare BDR values between non-asthmatic group and controller-naïve asthmatic group,          and analyze appropriate cut-off point value      Hypothesis:        1. Publications and our clinical experience indicate BDR value is affected by ethnicity,          and children are less responded to bronchodilator compared with adult patients. From          this aspect, data from Chinese children may be different from data included in the          guidelines which mostly determined by studies in adults        2. Reversible bronchospasm is a characteristic in asthma patients. Between asthmatics and          non-asthmatics, different response to BDR test would be observed, and there would be a          cutoff point with good sensitivity and specificity to differentiate asthmatics from          non-asthmatics      Background and rationale:      According to the guideline of global initiative for asthma, global strategy for asthma     management and prevention (GINA) and guideline of United States National Asthma Education and     Prevention Program (NAEPP) guidelines spirometry, including baseline forced expiratory volume     in 1 second (FEV1) and the bronchodilator response (BDR) to short acting beta agonists     (SABA), should be used in children as objective measures to establish the diagnosis and     severity of bronchial asthma. Spirometry is necessary because not every child came to the     clinic with typical symptoms and the objective measurement can improve diagnosis confidence.     Baseline FEV1, the so called gold standard for evaluating airway obstruction in adults, is     usually in the normal range (greater than 80% predicted) in children, regardless of asthma     severity. This substantially limits its value for diagnosis and assessment of response to     treatment. Because of this, several other objective measures have been suggested for     diagnosis and treatment in children, including the response to a bronchodilator, which     reflects not only airway reversibility, but also a marker of airway inflammation.      The current definition for a positive BDR is >12% reversibility and >200 ml increase from     initial FEV1 after short acting beta-agonist (SABA) has been used. However, recent reports     and our clinical observation revealed that, in a significant part of Chinese asthmatic     children, their BDR value cannot achieve 12% in the evaluation.      It has been suggested that the cutoff point of 12% is too conservative for pediatric     patients. In the study carried out by Galant et al among 51 non-asthmatic children and 346     controller naïve asthmatic children between 4-17 years, the BDR value could achieve 12% in     only 30.6% asthmatic children, across all severity. Meanwhile, when observing BDR value in     the above study, results were 2.2% (95% CI, 0.2-4.3) in the non-asthmatic group compared with     8.6% (95% CI, 7.5-9.8) in the asthmatic group. The range seen was 7.6% (95% CI, 5.8-9.5) for     mild asthma to 10.1% (95% CI, 7.6-12.6) in the severe persistent group. Also, in a study     among 142 children between 5-10 years in UK, 9% increase in FEV1 after bronchodilator use was     suggested as the cutoff point with good sensitivity and specificity. Moreover, in a study     carried out among 3052 children in rural area between 8-15 years in Anhui Province in China,     results showed BDR was 3 +/- 5% in non-asthmatic children, and 7 +/- 9% in asthmatic     children.      Difference between the proposed study to be carried out in our hospital and the one in Anhui     Province is that subjects in this proposed study are from 4-12 years old, which is the     largest patient segment in our clinic including preschool and school students. And most     importantly, the main purpose of study in Anhui is to observe the BDR range of the     non-asthmatic children and asthmatic children, while in our study, besides this objective,our     will tentatively calculate a BDR cutoff point by using receiver operating characteristic (ROC     curve). And the cutoff point can be used as a reference indicator in asthma diagnosis and     long-term management.      The current BDR cutoff point of 12% that is not ideal for children can also be reflected in     the clinical management. It has been shown that a persistent BDR value, even less than 12%,     in asthmatic children suggests poor clinical outcome. In a 4 years study among 1041 asthmatic     children in America carried out by Sharma et al, it showed that compared with individuals who     had a BDR of 12% and 200ml, individuals who had a BDR of 10% had similar poor clinical     outcomes (e.g. more hospital visits, more prednisone bursts, increased nocturnal awakenings,     and missing more days of school). Same results were also obtained in Galant et al study among     679 asthmatic children among 5-18 years.   "
136316|NCT01500512|"     This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph     node dissection. Sentinel lymph node dissection may have fewer side effects than removing all     lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors     confirm the safety of the procedure.   "
136317|NCT01500499|"     RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in     the laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research trial studies the role of biomarkers in disease progression in samples     from patients with acute myeloid leukemia.   "
136351|NCT01500031|"     Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total     occlusions in native femoropopliteal arteries.   "
136320|NCT01500447|"     Background:      - During puberty, children begin to develop into adults. Problems with the hormones released     during puberty can affect the reproductive system. Some people have low hormone levels that     severely delay or prevent puberty. Others start puberty abnormally early. Other people may     have a normal puberty but develop reproductive disorders later in life. Researchers want to     study people with reproductive disorders to learn more about how these disorders may be     inherited.      Objectives:      - To learn how reproductive system disorders may be inherited.      Eligibility:        -  People with one of the following problems:        -  Abnormally early puberty        -  Abnormally late or no puberty        -  Normal puberty with hormonal problems that develop later in life        -  People who have not yet had puberty but have symptoms that indicate low hormone levels.      Design:        -  Participants will provide a blood sample for testing. They will complete a questionnaire          about their symptoms. They will also have a scratch-and-sniff test to study any problems          with their ability to smell.        -  Participant medical records will be reviewed. Participants will also provide a family          medical history.        -  Family members of those in the study may be invited to participate.        -  Treatment will not be provided as part of this study.   "
136321|NCT01500434|"     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo     atherosclerotic coronary artery lesions. The lesions can be longer than average-sized.   "
136322|NCT01500421|"     This study is designed to investigate the safty and feasibility of therapeutic hypothermia in     acute stroke patients. Soon after arrival in the stroke unit patients are randomized to     either hypothermia in the intensive care unit (ICU) or standard treatment in the stroke ward.      Patients randomized to therapeutic hypothermia are analgo-sedated and cooled to at     temperature of 33 degrees for a period of 24 hours.   "
136323|NCT01500408|"     Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the     active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This     bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and     pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved     serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing     process.   "
136324|NCT01500395|"     The purpose of this study is to investigate the short to mid term efficacy and safety of     different hybrid operations who had complex aortic lesions, such as ascending aortic/arch     aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection,     dissection with primary tear located in the aortic arch, et al.   "
136325|NCT01500382|"     The study is designed to investigate the effects of the investigational drug vibegron     (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive     bladder. The study will also evaluate the safety and tolerability of multiple oral doses of     vibegron in women with overactive bladder. Overactive bladder is best described as urgency     and frequency of urination, with or without involuntary urination and/or the need to awaken     during the night to urinate.      The primary efficacy hypothesis is that vibegron is superior to placebo with respect to     change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e.,     steady state) in participants with overactive bladder. A true mean increase     (vibegron/placebo) of 25% in bladder volume is expected.      The primary safety hypothesis is that administration of multiple oral doses of vibegron is     sufficiently well-tolerated in participants with overactive bladder, based on assessment of     clinical and laboratory adverse experiences, to permit continued clinical investigation.   "
136326|NCT01500369|"     Atrial fibrillation is the most common arrhythmic complication after coronary artery bypass     grafting (CABG). Post operative atrial fibrillation (POAF) increases morbidity and mortality.     Inflammation could be a factor in POAF and recent evidence of remotely inducing ischemia may     reduce inflammation and cardiac injury. The investigators plan to use a blood pressure cuff     on the arm as a method to produce remote ischemia and assess the occurrence of POAF for seven     day.   "
136327|NCT01500356|"     The primary aim of this study is to examine the effect of the consensus public health     recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk]     versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in     the context of a comprehensive behavioral weight loss program that a includes a reduction in     energy intake measures of cardiovascular function using cardiac MRI and biomarkers of     vascular disease risk. Each of these exercise doses will be compared independently to a Diet     Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also     compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults     who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for     a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes     include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume,     aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines     (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body     composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids,     glucose, insulin, blood pressure). Additional secondary analyses will allow for examination     of the effects of physical activity independent of weight change on the primary and secondary     outcomes.   "
136343|NCT01500135|"     Present trial is the third study that in combination with two completed studies (one being a     trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted     toward providing clinical safety and efficacy data to support extending the current label of     TachoSil® to a general hemostasis indication across several surgical procedures and organ     systems in the USA.   "
136344|NCT01500122|"     The primary objectives of the study are:        -  To compare the pharmacokinetic profiles of RhuDex administered as two novel oral          formulations        -  To identify the lead formulation and optimise the pharmacokinetic profile by modifying          the quantitative composition of that formulation        -  Optional: To assess the intravenous pharmacokinetics of RhuDex following administration          of an IV microtracer of [14C]RhuDex   "
136409|NCT01499277|"     The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin     plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue     infections.   "
136330|NCT01500317|"     Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the     dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is     potential for off label use in chronic pain.      Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is     a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid     receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in     pain relief. While its action reflects aspects of tramadol and morphine, its ability to     control pain is more on the order of hydrocodone and oxycodone.      Its dual mode of action provides analgesia at similar levels of more potent narcotic     analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect     profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain     in various pain care settings. In addition, it was reported to be associated with     significantly fewer treatment discontinuations due to a significantly lower incidence of     gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The     combination of these reduced treatment discontinuation rates and tapentadol efficacy for the     relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in     pain therapy by increasing patient compliance with their treatment regimen.   "
136331|NCT01500304|"     The purpose of this this study is to determine if a structured educational training program     is successful in teaching surgeons a new operative technique. It will then be determined if     this new operative technique is safe.   "
136332|NCT01500291|"     It is inevitable that nearly both anesthesiologist and nurse anesthetist take a zero     tolerance approach to avoidable safety problems in the provision of anesthesia.      We would like to study the stress upon anesthesia personnel by using Suanprung Stress Test     (SST) - a well-documented, psychological stress test, and Siriraj Anesthesia-related Stress     Test (SAST) - a new developed open-ended opinion poll, to scrutinize the daily rounds stress     and yield the solution to eradicate or alleviate those worries as well as improve both     physical and mental health to handle the situation of difficulties.   "
136333|NCT01500278|"     This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy     of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in     the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding     adequately to MTX.   "
136334|NCT01500265|"     Nucleotide analogues are associated in the long term with a risk of proximal tubular     nephropathy (PT) with loss of phosphate, and, when compensatory mechanisms are overwhelmed,     with osteopenia or osteoporosis. This toxicity has been particularly documented for tenofovir     (TDF) in HIV disease, but its prevalence varies widely in the literature and is mainly     associated with comorbidities: on average this prevalence is 0.39% after 48 weeks with     exceptional cases of Fanconi syndrome described. In HBV monoinfection after 60 months of     treatment with TDF, an 11% decrease of creatinine clearance (CreatCl) is observed. A single     study showed a significant increase in creatinine level with entecavir (ETV) therapy, a     second-generation nucleoside, hitherto not described as nephrotoxic. Furthermore, if the     direct renal toxic effect characteristic of HIV in the kidney is well known, the role of HBV     is less clear. Thus, HBV treatment appears to have a renal protective effect. The monitoring     tools recommended by the SPC, CreatCl and plasma phosphorus level are late markers of tubular     damage. The threshold of phosphate tubular reabsorption (TmPi/GFR) and the fractional     excretion of uric acid (FEUA) are unexpensive early screening tools. However, the long-term     evolution of this subclinical tubular involvement in HBV monoinfection is not known.   "
136335|NCT01500252|"     Background:      Despite the excellent results of total knee replacement, also known as total knee     arthroplasty (TKA) there is persistent controversy over whether or not to replace the surface     of the kneecap. Anterior knee pain, which occurs with variable and unpredictable frequency,     continues to be a problem in a subset of TKA patients. Some clinicians replace the surface of     all kneecaps during TKA to avoid repeat surgery, which occurs in approximately 10% of cases.     However, others cite the complications attributed to replacing the surface of kneecap as     reasons to avoid this procedure.      This study prospectively randomized patients receiving TKA into two groups, those receiving     replacement of the kneecap surface and those left without replacement of the kneecap surface     to determine clinical outcomes and revisions over the first 5-10 postoperative years.      Objectives:      The primary objective of this work was to compare pain, stiffness and function between groups     at five years postoperatively. Secondarily, we compared pain, stiffness and function at one     and 10 years postoperatively. Finally, we examined the number of reoperations following TKR     over 10 years in the 2 groups of subjects. The investigators hypothesized that there would be     no difference between the two groups of subjects in the measured outcomes.      Methods:      Patients receiving TKA were prospectively enrolled before surgery and randomized     intraoperatively to either receive a replacement of the kneecap surface or have no kneecap     intervention. The Smith and Nephew Profix TKA system was implanted in all cases; the     post-operative regimen was standardized. Subjects were assessed pre-operatively and at 1 and     5 years postoperatively for pain, function, and stiffness using a disease-specific (Western     Ontario and MacMaster Osteoarthritis Index [WOMAC]) and generic health status (Short Form 36     [SF-36]) questionnaire. At the end of the five year follow-up, the study was extended to a     10-year followup and the same outcomes were assessed. The revision rate was also compared     between the two groups at the end of the 10-year follow-up.   "
136336|NCT01500226|"     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled     study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered     prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects     will record all events of emesis and the use of rescue medication for established nausea     and/or vomiting, and will indicate the severity of nausea they experienced in each of the     previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to the MEC     administration through Day 6 in Cycle 1. Health-related quality of life will be measured by     the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by     clinical review of adverse events (AEs), physical examination, electrocardiograms (ECGs), and     safety laboratory values. All subjects are expected to complete Cycle 1 and will have the     option of participating in up to five additional cycles.   "
136337|NCT01500213|"     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled     study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2     hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone.     Subjects will record all events of emesis and use of rescue medication for established nausea     and/or vomiting, and will indicate the severity of nausea they experienced in each of the     previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration     through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE     Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical     review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety     laboratory values.      All subjects are expected to complete Cycle 1 and will have the option of participating in up     to five additional cycles.   "
136347|NCT01500083|"     The purpose of the current study is to evaluate additional safety data of bendamustine in up     to 100 patients with Indolent Non-Hodgkin's Lymphoma (iNHL) relapsing from a rituximab     regimen or Chronic Lymphocytic Leukemia (CLL). Patients will receive up to 6 or 8 cycles of     bendamustine treatment using the dosing regimens of TREANDA® (bendamustine) approved in     several countries, which have been shown to be reasonably well tolerated. The study protocol     includes safety monitoring (i.e., adverse events, concomitant medications, supportive care,     clinical safety laboratory tests, and clinical disease status monitoring).      It is an interventional, multicentre, prospective, open-label expanded access study, which in     addition allows investigators in Canada, and their patients, access to bendamustine while it     is pending Canadian marketing approval.      Although the treatment options available for patients with iNHL or CLL do induce substantial     responses, there is no curative treatment. One potential drug candidate for the treatment of     CLL and iNHL is bendamustine.      Bendamustine has been widely used in Germany for more than 30 years and is marketed in the     United States for treatment of CLL and for treatment of iNHL that has progressed during or     within 6 months of treatment with rituximab or a rituximab-containing regimen. In October     2010, the European Medicines Agency formally approved bendamustine in a number of Member     States of the European Union for the treatment of patients with iNHL, CLL, and multiple     myeloma. The drug's safety profile in these patient populations has been extensively     characterized and no unexpected safety concerns are anticipated.   "
136348|NCT01500070|"     This is a single-arm, prospective, multi-center monitored trial recruiting patients with     critical limb ischemia and with one or more lesions in the arteries below the knee. The     immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting     Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System     (Boston Scientific) will be evaluated.      In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will     be recruited. Primary endpoint is primary patency at 12 months, defined as absence of     restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on     angiography.   "
136349|NCT01500057|"     This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus     BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic     Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up     visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.   "
136350|NCT01500044|"     The primary objective of this randomised clinical trial (RCT) is to compare, in terms of     disability and pain, an intervention targeting the opening of intervertebral foramens to a     conventional physiotherapy intervention, in patients presenting acute or subacute cervical     radiculopathies. Based on biomechanical principles, the investigators hypothesis is that the     intervention targeting the opening of intervertebral foramens will be significantly more     effective in reducing pain and disability than the conventional physiotherapy intervention.      This study is double-blind RCT that will allow the comparison of patients with a cervical     radiculopathy randomly assigned to one of two groups: one group will receive a 4-week     rehabilitation program targeting the opening of intervertebral foramen, and the second group     will receive a 4-week conventional rehabilitation program. Thirty-six subjects will be     recruited from participating medical and physiotherapy clinics in the Quebec City area     (Canada) and will be evaluated at baseline, at the end of the program and four weeks     following the end of the program. The primary outcome measure will be the validated Neck     Disability Index (NDI) questionnaire and other secondary measures will include the QuickDASH     questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients'     perceived global rating of change.   "
136353|NCT01500005|"     The incidence of type 2 Diabetes Mellitus is increasing at an alarming rate worldwide.      Cardiovascular disease is the leading cause of death in patients with type 2 diabetes.      Recently, increasing amount of evidence suggests that vitamin D may influence various     nonskeletal medical conditions, including cardiovascular disease, hypertension, diabetes,     cancer, autoimmune disorders and more. The purpose of this trial is to investigate the effect     of vitamin D supplementation on 24 hours blood pressure monitoring, arterial stiffness,     oxidative stress and inflammation in vitamin D deficient diabetic patients.   "
136354|NCT01499992|"     The aim of this study to define the optimal rehabilitation for clients with full thickness     rotator cuff reconstruction, with two goals: 1. Finding the optimal physical therapy dosage     in enhancing post-operative outcomes of shoulder pain, shoulder joint range of motion,     shoulder muscle strength, upper extremity function; and 2. Finding the effect of aquatic     physical therapy in enhancing the post-operative outcomes.   "
136355|NCT01499979|"     Rationale      Currently, hepatic resection is often the only curative treatment for primary or secondary     hepatic malignancies and is also frequently performed in patients with benign liver tumors to     prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays     associated with low mortality and acceptable morbidity. As result of that, an increasing     number of patients is currently under consideration for resection of more complex or large     tumors, thus requiring extensive resection procedures. Application of vascular exclusion     (i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood     loss, which is one of the most important factors affecting peri-operative outcomes. However,     vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect,     which adversely impacts postoperative liver function and regeneration. Additional cooling of     the liver by means of hypothermic perfusion is expected to further reduce intraoperative     blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this pilot     study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy under     vascular exclusion. Consequently, an overall improvement in postoperative outcomes is     expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a     better ability of the liver remnant to regenerate.      Objective      To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during     right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion with     retrograde outflow (R-IHP) of the FRL.      Study design      The study is designed as a prospective randomized pilot study in 18 patients (9 interventions     and 9 controls) to assess the effects of the proposed intervention. Additionally, 4 patients     will be included separately for assessment of the intervention's feasibility prior to     randomized inclusion.      Study population      Eligible patients for participation in this study are those planned to undergo right     hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver tumor,     and who do not suffer from any hepatic co-morbidity that might influence postoperative     outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C infection).      Intervention      During right hemihepatectomy, the FRL of patients allocated to the intervention group will be     perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).   "
136356|NCT01499966|"     Until now very few studies have been done to compare the efficacy of tubigrips or plaster of     paris in the treatment of lateral ankle sprains, the investigators aim to compare the     tubigrip against plaster of paris in the treatment of lateral ankle sprains.   "
136357|NCT01499953|"     The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus     fondaparinux in the treatment of superficial vein thrombosis (SVT).   "
136358|NCT01499940|"     Many patients with cancer that are treated with a drug called oxaliplatin. This drug is used     with other drugs to treat cancer. The drug can cause problems with the nerves in the hands     and feet called peripheral neuropathy (a side effect of the drug). Peripheral neuropathy may     make the hands and feet feel like they are tingling, have a burning feeling, and can cause     pain. Almost all patients who receive oxaliplatin as part of their cancer treatment have     peripheral neuropathy. Patients who do have this side effect usually have to take a lower     dose of or stop taking the oxaliplatin even if the drug is helping their cancer.      So far there is not a lot of information about how to make this side effect better or help it     go away completely. There is some information that low levels of Vitamin D in the blood might     be linked to problems or diseases of the nervous system like multiple sclerosis or     Parkinson's Disease. It is even thought that Vitamin D may help protect the cells in the     nervous system. Because of this information, researchers want to see if giving patients     Vitamin D while they are receiving the drug oxaliplatin to see if it helps prevent the side     effect peripheral neuropathy.      Patients taking oxaliplatin who want to be in this study will take one Vitamin D capsule each     day while they take oxaliplatin. Being in this study will not affect how the patient's cancer     is treated. There are blood tests in the study to check Vitamin D levels and for a protein     called nerve growth factor (NGF). The study team will carefully monitor the patients for any     signs of oxaliplatin-related neurologic toxicity during the study.   "
136359|NCT01499927|"     Switching from intravenous application of antiinfective agents to oral therapy is often     performed late including high costs and risk of complications. This study will investigate     the impact of displayed reminders in the electronic patient chart after 60h of intravenous     therapy with an antiinfective agent.   "
136360|NCT01499914|"     Multicenter prospective cohort of approximately 1000 cystic fibrosis patients followed in the     Ile de France during the 2009-2010 influenza season with the main objective to assess the     effectiveness of antiviral vaccination (H1N1). All subjects will be included, without     excluding factor. In particular populations at risk are additional infants 6 to 23 months,     pregnant women and lung transplant will also be included. These people will be vaccinated     with un-adjuvanted vaccine.      If flu symptoms until the results of PCR to confirm or refute the diagnosis of influenza,     oseltamivir is administered in accordance with official recommendations and based on the     results of the pharmacokinetic study.   "
136361|NCT01499901|"     In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The     impact on perception and language of bilateral CI simultaneous versus sequential has to be     established before discussing the enlargement of indications.   "
136362|NCT01499888|"     The investigators propose to determine the engraftment and transplant related morbidity and     mortality after a non-myeloablative allogeneic hematopoietic stem cell transplant protocol     using immune- suppressive agents and low-dose total body irradiation (TBI) without standard     chemotherapy in patients with aggressive sickle cell disease who are not candidates for or     experienced complications from hydroxyurea therapy.      Fully HLA matched siblings will be used as donors for hematopoietic stem cells to reduce the     risk of morbidity and mortality in this cohort of patients.   "
136363|NCT01499875|"     The aim of this trial is to evaluate the pharmacokinetics and pharmacodynamics of penicillin     V in non-infectious children to estimate the optimum dosage regime in children.   "
136364|NCT01499862|"     This pilot study examined the effect of task-oriented mobility training in three persons     chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion     Bionic Leg).   "
136365|NCT01499849|"     This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled     study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered     prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects     will record all events of emesis and use of rescue medication for established nausea and/or     vomiting, and will indicate the severity of nausea they experienced in each of the previous     24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through     Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire     on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse     events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.      All subjects are expected to complete Cycle 1 and will have the option of participating in up     to five additional cycles.   "
136366|NCT01499836|"     Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain     and side effects after breast surgery when used in addition to general anesthesia or     sedation.The investigators would like to further discern the impact of GA or PVB on the     postoperative QoR, pain and satisfaction.   "
136367|NCT01499823|"     The aim of the present study is to assess whether a new method of quantifying     therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish     pseudoprogression from true progression in patients with high grade glioma, who received     CCRT.   "
136368|NCT01499810|"     Single-center, single group study of the efficacy and safety of transcatheter renal     denervation for treatment of patients with essential hypertension uncontrolled despite     combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic.     Bilateral transcatheter renal denervation will be performed on the top of existed     pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery     thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of     follow-up.   "
136369|NCT01499797|"     The purpose of this study is to investigate the effect of the CareWell-programme on overall     functioning of community-dwelling frail elderly persons. Furthermore, the total costs and the     cost-effectiveness of the CareWell-programme, in comparison with regular medical care, will     be studied.   "
136370|NCT01499784|"     Urinary incontinence (UI) is a very common condition in women, with estimates of prevalence     varying from 10% to 40% in most studies and showing a gradual increase with age. UI is a     serious medical problem that can lead to urinary tract infections, low back pain, respiratory     disorders, pressure sores, and an increased risk of falls. It also leads to social problems,     creating embarrassment and negative self-perception for those who suffer from it. Women with     urinary incontinence find themselves isolated and relatively inactive. A wide range of     treatments has been used in the management of women's UI, including conservative     interventions, pharmaceutical intervention, and surgery. A Cochrane Review from 2008 stated     that pelvic floor muscle training (PFMT) is better than no treatment for UI and supports the     recommendation that PFMT should be the first treatment line in conservative management     programs for women with UI. Recently, there have been a few articles published that looked at     the effectiveness of treating UI in a group-like setting with both behavioral modifications     and pelvic floor exercises. One study was able to prove that group training of behavioral     modification helped to reduce UI severity, increase pelvic floor strength, and reduce voiding     frequency when compared to a control group.      All of the studies cited were performed in community-dwelling persons with out-patient     services and interventions. Dr. Fitzgerald and her colleagues from The Rehabilitation     Institute of Chicago (RIC) were able to confirm in a poster presentation that many patients     admitted to an inpatient rehabilitation facility do have UI. In 2005, out of 403,697 Medicare     beneficiaries admitted to a rehab hospital, 24% were incontinent. These studies were able to     illustrate that UI affects all diagnoses. UI was shown to make a significant contribution to     patient outcomes independent of functional status at admission. It is also a large     determinant of discharge destination. In the United Kingdom in 2004, 62% of incontinent     stroke patients were discharged to a sub acute home with only 5% placement for continent     stroke survivors. Another study determined that urinary incontinence after having a stroke     predicted a higher likelihood of an adverse outcome when controlled for age, type of stroke,     and length of hospital stay. May, et. al., was able to state while in an acute rehab setting     that patients with spinal cord injuries ranked bowel and bladder care, along with skin care,     as most important in an education class with 12 different topics. This shows that patients     find bladder function a large priority in their care, even in an in-patient setting. In the     poster presentation mentioned above, many patients with UI in an acute care rehab setting do     not improve Functional Independence Measure (FIM) status from admission to discharge.     Currently there is no research available for the treatment of UI in an acute care rehab     hospital, though it has been shown to be an issue with many of those admitted. So the     question arises, Would addressing urinary incontinence with physical therapy interventions     and behavioral modifications improve incontinence in this population during the acute rehab     stage?   "
136371|NCT01499771|"     This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets     (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM     Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of     80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)     distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80     mg tablet) in healthy adult subjects when administered under fed conditions.   "
136372|NCT01499758|"     This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets     (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM     Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of     80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)     distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80     mg tablet) in healthy adult subjects when administered under fasting conditions.   "
136373|NCT01499745|"     -  Idiopathic pulmonary fibrosis (IPF) is a chronic progressive, fibrosing parenchymal lung          disease with unknown etiology. The prevalence of IPF is estimated between 2-29 cases per          100,000 in general population with median survival rates of 2-5 years from time of          diagnosed.        -  Dyspnea and chronic dry cough are the prominent symptoms in those patients which cause          to impaired functional capacity and quality of life (QOL).        -  Drug therapy usually is ineffective approach, what makes a call for an effective          treatment.        -  Pulmonary Rehabilitation (PR) had been founded as safe and effective treatment in          increasing functional capacity, decrease symptoms and improve QOL mainly among Chronic          Obstructive Pulmonary Disease (COPD). However, recently growing evidence also supports          the efficiency of PR in IPF patients.        -  The Aim of the suggested study is to examine the effect of exercise training (ET) at          ambulatory pulmonary rehabilitation among IPF patients.        -  The investigators hypothesize that ET at PR program will increase functional capacity,          will decrease level of dyspnea and improve QOL in IPF patients.        -  Patients and Methods:        -  40 IPF patients males and females (aged 30-90 years old) will be recruiting to this          study. After clinical assessment they will be randomly allocated to PR group n=20 or to          Control group n=20.        -  All patients will undergo a clinical assessment including medical history, risk factors          for IPF and physical examination. On the first meeting at baseline and within one week          post intervention (PR) the following measurements will be made: dyspnea score, QOL and          physical activity level questionnaires. In addition, anthropometric measurements,          echocardiography, blood samples, pulmonary function tests, cardiopulmonary exercise          test, battery of functional test and 6 minute walk test (6MWT).        -  The PR group will participate in 12 weeks of supervised group's ET program. The training          program will be consisted two 6 week blocks of 60 min exercise bout twice a week. In the          first block the patients will perform aerobic interval training with treadmill walking,          cycling, and step climbing. In the second block, subjects will perform longer periods of          continuous aerobic exercise, with resistance training by step climbing, unsupported          arm/leg exercises with and without dumbbells (0.5-1 kg), and supporting body weight over          a chair. Pulmonary function test and 6MWT will be also performed after completing first          6 week block. The control group will be assessed at baseline and after 12 weeks without          participating in PR program.   "
136374|NCT01499732|"     Premature Endothelial Dysfunction is present in patients with early rheumatoid arthritis.   "
136375|NCT01499719|"     The purpose of this clinical trial is to evaluate the effectiveness of a new surgical     checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and     to measure the frequency of compliance by surgical personnel at OHSU with specific daily     safety protocols before and after introduction of the checklist. The investigators     hypothesized that the use of an ESS specific surgical checklist will improve the frequency of     compliance by surgical personnel at OHSU to internal safety concerns and protocols.   "
136376|NCT01499706|"     The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to     rise due largely to        -  better clinical care and the improved efficacy of highly active antiretroviral therapy          that has extended the lives of many HIV-positive persons        -  an increase in the number of new HIV infections in older persons. This study tested the          efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction          interventions for HIV-positive adults 45-plus years of age who engage in risky sexual          behaviors.   "
136377|NCT01499693|"     The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day     (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium     pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and     standard dose of proton pump inhibitors.   "
136378|NCT01499680|"     This is a prospective, non-randomized multi-center study to evaluate intraoperative     neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF)     surgery at any number of levels inclusive of L4-5.   "
136380|NCT01499654|"     This study is recruiting patients already scheduled for a single photon emission computed     tomography myocardial perfusion imaging (SPECT-MPI) test. SPECT-MPI is a nuclear imaging     technique that uses a radioactive substance, or radiotracer, and special equipment to create     three-dimensional (3D) images of the heart. Radiotracer is a radioactive dye that will make     the structures of the heart visible and is routinely used to view blood flow in the heart,     scan for damaged heart tissue, or assess heart function.      For a routine SPECT-MPI test, the radiotracer is given in one dose at the beginning of the     test, followed by taking resting images of the heart. For this study, researchers would like     to administer half of the radiotracer, obtain resting images, administer the remainder of the     radiotracer and obtain a second set of resting images. Participants will receive the same     amount of radioactive material that would normally be given for this test; however, it will     be administered in two half-doses. Participation in this study will add about 30 minutes to     the time it takes to complete the routine test. The investigators expect to enroll about 160     subjects in this study at Northwestern.   "
136381|NCT01499641|"     Focus of this study is evaluation of the outcome, neurologic impairment and safety of     epidural steroide following lumbar discectomy for herniated disc disease.   "
136382|NCT01499628|"     Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in     the UK, Europe and N America. Low vision patients with AMD have great difficulty reading,     which leads to a loss of independence and reduced quality of life. Magnifiers alone do not     compensate for loss of central vision in AMD. It has been proposed that special low vision     training can improve reading ability in patients with AMD. Training programmes are widely     available in the US and Scandinavia, but not in the UK, partly because there is a lack of     evidence from Randomised Control Trials (RCT) showing that they are effective. The     investigators are conducting a clinical trial comparing the conventional hospital−based low     vision service to enhanced rehabilitation programmes that include Eccentric Viewing training.     Eccentric viewing training involves teaching patients who have lost their central vision to     use a new area of retina for visual tasks. Patients are either taught to improve the use of     the part of the retina they naturally start using after their central vision is lost, their     so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a     different retinal area that is thought to be better suited for everyday visual tasks, the     so-called trained retinal locus (TRL). The investigators plan to compare the two types of     eccentric viewing training to conventional hospital-based low vision care.   "
136436|NCT01498913|"     This study is conducted in Asia. The aim of this study is to review the safety and efficacy     of Novonorm® (repaglinide) in post-marketing use.   "
136383|NCT01499615|"     Traditionally cardiac output has been estimated with thermodilution. Recently a new     non-invasive device has been approved by the FDA for use in children of all ages including     neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous     physiologic data for all enrolled children by transferring the data from the investigators     computerized anesthesia records to Excel spreadsheets and to correlate adverse events across     monitoring devices.      Secondary outcomes: To determine if the device provides meaningful data in terms of an early     warning of decreased cardiac output in specific subgroups of children undergoing surgery and     anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those     undergoing procedures with expected blood loss, those undergoing laparoscopic procedures     where gas insufflation may impede venous return to the heart.   "
136384|NCT01499602|"     The purpose of this study is to compare the efficacy of the Levonorgestrel releasing     Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical     endometrial hyperplasia in perimenopausal women.   "
136385|NCT01499589|"     Study of time usage of anesthesia team inside the main operating room compares between 2     groups of        -  Performing regional anesthesia inside the operating room        -  Performing regional anesthesia in the block room      Study purpose: How much will the investigators save time in the main operating room if we     perform the regional anesthesia in the block room?   "
136386|NCT01499576|"     The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high     risk group of gastric cancer. Many methods was developed to survey it, including multiple     gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine     screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used     in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The     investigators have confirmed such whitish discoloration is induced in gastric IM, with     accuracy > 80% in a pilot study of the investigators. This prospective study will tell the     accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.   "
136387|NCT01499563|"     The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms     associated with schizophrenia in patients who are having an acute worsening of their     psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007,     placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on     psychosis. The safety of ITI-007 will also be assessed.   "
136388|NCT01499550|"     On the basis of different studies the long term oxygen treatment is deemed to be routine     treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at     appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in     hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation.     Several prospective randomized studies have shown a reduction of acute mortality as result.     But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom     oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary     overinflation or the appearance of depressions or rather anxiety disorders are possible     causes. On the other hand patients may not notice any subjective improvement of symptoms and     won't accept the burden of a tight fitting mask during the night. The aim of the present     study is to determine the effect on gas exchange of a nocturnal transnasal application of an     oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is     compared to a nocturnal transnasal application of oxygen alone in randomized order for at     least 6 hours each night.      Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night     Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements,     breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At     begin and end of each measurement night a capillary blood gas analysis is made.   "
136389|NCT01499537|"     At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard     method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail     or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is     the most commonly used alternative, surgery having higher morbidity and mortality rates,     unacceptable especially in palliative situation. Recent developments in interventional     endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary     structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described     the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric     wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not     suitable endoscopically (duodenal stricture or post-surgical status) and to allow if     necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is     actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have     less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the     percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25     to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of     this study are to compare the morbidity rate, feasibility and efficacy of these techniques.   "
136390|NCT01499524|"     ICP is known to cause abnormal bile acid homeostasis and to be associated with an increased     risk of diseases of the biliary system in later life. There have been small studies (Dann et     al. 2006; Wójcicka-Jagodzińska et al. 1989) suggesting that it causes dyslipidaemia (raised     lipids) and impaired glucose tolerance in pregnancy. However the underlying mechanisms of     these abnormalities is not known. Similarly the influence of cholestasis on fetal metabolism     is not known, and nor is the role of the placenta. It is also not known whether women with     ICP have a predisposition to abnormal lipid and glucose homeostasis when they are not     pregnant.      GDM is characterized by raised plasma glucose levels in pregnant women (in the absence of     pre-pregnancy diabetes mellitus). This condition is associated with large-for-gestational age     babies and obstructed labour. Women with GDM have increased risk of subsequent type 2     diabetes mellitus, and if they have this condition in a subsequent pregnancy there is an     increased risk of stillbirth. This work is important to understand the causes of the     metabolic abnormalities associated with ICP and GDM. If we demonstrate abnormal lipid and     glucose profiles, these may be of relevance to the fetal complications of both disorders. It     will also be of relevance to the future health of affected women and their children.   "
136391|NCT01499511|"     ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the     Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and     2005.ASCOT's results showed substantial cardiovascular benefit from: 1) the use of a     cholesterol lowering drug (atorvastatin) compared to placebo, and 2) the use of a     blood-pressure lowering strategy based on amlodipine when compared to a strategy based on     atenolol. ASCOT-10 will test the hypothesis that the ASCOT subjects who originally received     Atorvastatin and those who received amlodipine based treatment will continue to show a     cardiovascular benefit relative to those who did not, even though all the subjects have had     access to optimal treatment in the interim.   "
136392|NCT01499498|"     This is a healthy volunteer study looking at the interactions between two drugs: boceprevir     and sildenafil.      New drugs are being developed to treat people with the chronic viral infection hepatitis C.     Very little is know how these new treatments interact with other medications such as the     drugs used to treat erectile dysfunction.      The purpose of this study is to look at levels of both a new hepatitis C drug called     boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they     affect the blood levels of each other when given separately and together.   "
136393|NCT01499485|"     The purpose of this study is to analyze whether the treatment of metabolic alkalosis with     acetazolamide in intubated patients with chronic obstructive pulmonary disease (COPD) or with     obesity hypoventilation syndrome (OHS) reduces the length of mechanical ventilation (MV).   "
136394|NCT01499472|"     The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added     to standard of care wound therapy significantly improves time to complete wound healing in     diabetic foot wounds.   "
136395|NCT01499459|"     This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC)     transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem     cell will be derived from patients' bone marrows and will be infused via peripheral vein.     Liver biopsies will be performed in every patient in the beginning and at 6th month.   "
136396|NCT01499446|"     The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once     daily either in the morning or the evening and GW685698X 250mcg administered once daily in     the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.   "
136397|NCT01499433|"     The investigators propose to study the efficacy and safety of three-week antifungal therapy     with caspofungin in hospitalized patients with proven or probable IPA underlying chronic     obstructive pulmonary disease.   "
136398|NCT01499420|"     Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS)     may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent     cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single     ascending dose study in patients with stable atherothrombotic disease in whom the safety and     pharmacokinetic profile of CSL112 will be assessed.   "
136399|NCT01499407|"     Subjects with ST-elevation myocardial infarction will be randomized, to one of the following:     abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A),     thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy     followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that     abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration     (groups C or T+C) will result in a significant reduction of intra-stent thrombus formations     when compared to intravenous or intracoronary abciximab with or without thrombectomy (groups     A or T+A). The primary endpoint will be the number of cross sections with thrombus area >10%     immediately after stent implantation as assessed with OCT. Additional angiographic, ECG, and     clinical endpoints will be collected and adjudicated. This trial is currently being     registered at ClinicalTrials.gov.   "
136400|NCT01499394|"     The Biorepository for Caris Life Sciences is designed for the purpose of making quality     biospecimens and associated clinical data available for research studies related to advancing     precision medicine and improving care for patients.      The Caris Biorepository is a repository of prospectively collected biological specimens and     associated clinical and demographic data gathered from multiple sources to be stored, used     and shared for research. Caris Life Sciences will maintain the data and specimens and will     control access to and use of the information and specimens by multiple individuals for     multiple purposes which may evolve over time.   "
136401|NCT01499381|"     The objective of this multi-center prospective observational clinical study is to evaluate     the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of     prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of     the Carisome Prostate assay will be compared with pathology results of prostate biopsy     procedures. Secondarily, the performance of the Carisome Prostate test will be compared to     the current standard of care for the detection of prostate cancer.   "
136402|NCT01499368|"     To evaluate the healing rate and safety of Lafutidine in erosive esophagitis   "
136403|NCT01499355|"     The primary objective of the study is to assess the efficacy of BIIB023 as an add-on     treatment to background therapy compared with placebo in combination with background therapy     in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary     objectives of this study are to assess the safety and tolerability of BIIB023 compared with     placebo in this study population.   "
136404|NCT01499342|"     This is a Belgian prospective multicentre registry to evaluate safety and performance of the     Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic     lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed     for a period of 2 years.   "
136405|NCT01499329|"     The purpose of this study is to evaluate safety and performance of the balloon-expandable     Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC)     A, B, C and D iliac lesions.   "
136406|NCT01499316|"     Coronary artery disease (CAD) is a condition which refers to the narrowing of the small blood     vessels that supplies blood and oxygen to the heart. It is a common cause of chest-pain     related symptoms and as a result of a 'heart attack'. In most cases, to assess the severity     of the disease is to use coronary angiography, which is a medical imaging technique that uses     contrast (a dye) and x-ray to show the blood-flow supply of the coronary arteries.      The optimal treatment for patients with symptomatic coronary disease is aggressive medical     therapy. Current guidelines recommend patients with symptomatic CAD and severe disease on     angiography undergo revascularisation therapy, which aims to restore blood flow to blocked     arteries. This can be done by either percutaneous coronary intervention (feeding a small     balloon or other device on a thin tube through blood vessels to the point of blockage and     then inflate the balloon to open the artery), or coronary artery bypass grafting (open-heart     surgery)2.      For many symptomatic patients who have only moderate disease on angiography, further     functional testing is required to assess the extent of the blockage. This can be achieved by     placing a pressure wire to the artery of interest, to determine the likelihood that the     blockage impedes oxygen delivery to the heart muscle, known as the Fractional Flow Reserve     (FFR)3. FFR is commonly performed at the Alfred hospital in the assessment of such patients.     During an FFR procedure, further information regarding the health of the small arteries of     the heart can be obtained with the calculation of the index of micro-vascular resistance     (IMR),      Giving oxygen to patients with CAD is a common clinical practice, especially to all patients     in the catheterisation laboratory whose had a 'heart attack' and often administered     concurrently with light sedation during elective procedures.      Recently, however, the safety of routine supplemental oxygen in patients with CAD has been     questioned5. A research study analysed the outcomes of three small randomised studies on     oxygen in patients who experienced a 'heart attack', while suggestive of harm, the findings     of the study remain inconclusive.      There may also be deleterious effects of supplemental oxygen, on more stable patients with     CAD, who are not experiencing a 'heart attack'. Supplemental oxygen administered in the     catheterisation laboratory to patients with stable CAD, has been shown to significantly     reduce coronary artery blood flow and increase its resistance6-8. It has also been shown to     reduce cardiac output and effect the relaxation phase of the heart cycle. Based on this data     it is hypothesised that supplemental oxygen may affect FFR in patients with moderate CAD. The     investigators therefore propose to undertake a study of the effects of supplemental oxygen on     FFR in patients with moderate CAD.      The patients enrolled into the study will be scheduled for an elective normal contrast     diagnostic or interventional procedure as part of their clinically-indicated care. Once a     moderate blockage of the artery has been identified, FFR and IMR will be measured. During the     first phase of the FFR study, the patient will breathe room air and have a blood test to     measure their oxygen level (blood gas). There is a 3 minute washout period, followed by the     second phase, whereby the patient will be given 100% oxygen for 10 minutes and have another     blood gas measured.      The study will be conducted at Alfred Hospital with a total enrollment of 18 subjects. The     estimated time to complete enrollment is 6-10 months.      Data collected on each patient will include demographics, medical history, vital signs (heart     rate, blood pressure, height, and weight), usage of cardiovascular medications, pathology     results and procedural records. Any adverse events or serious adverse events related to the     study procedure will also be recorded.   "
136407|NCT01499303|"     This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients     with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large     B-Cell Lymphoma (abbreviated as DLBCL)   "
136408|NCT01499290|"     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus     Metronidazole compared to Meropenem for treating hospitalized patients with complicated     intra-abdominal infections.   "
136410|NCT01499264|"     Evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best     practice clinical care in subjects with burn injuries with particular regard to: 1) Wound     healing (complete reepithelialization), 2) the patient's pain. In the context of the study     will be collected secondary outcomes related to type of lesion and its clinical evolution     through the analysis of the items in the scale of the PSST.   "
136411|NCT01499251|"     This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of     macitentan in combination with dose-dense temozolomide in adult patients with recurrent     glioblastoma or gliosarcoma. The study is composed of three parts. A Phase 1 Dose Escalation     Period with a traditional 3+3 design will determine the maximum tolerated dose of macitentan     in combination with dose-dense temozolomide. A Phase 1b Period will expand the safety and     tolerability data of two doses of macitentan and dose-dense temozolomide selected from the     Dose Escalation Period and explore efficacy. An Ancillary Study will further evaluate the     effects of macitentan on biomarkers in brain tumor tissue.      The study is planned to have a minimum duration of 12 months. The study will end when all     patients (excluding those prematurely withdrawn or lost to follow-up) in each part of the     study have completed a visit at month 12 and 30 days of safety follow-up.   "
136412|NCT01499238|"     The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with     wet lung.   "
136413|NCT01499225|"     This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients     with chronic periodontitis, in order to investigate the recommended therapeutic dose.   "
136414|NCT01499212|"     The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio     1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the     lateral decubitus position.   "
136415|NCT01499199|"     ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be     conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.     Subjects who fulfill eligibility requirements will receive dolutegravir (DTG) 50 mg once     daily in combination with the fixed dose dual nucleoside reverse transcripatase     inhibitor(NRTI) abacavir/lamivudine (ABC/3TC) for 96 weeks. One pair of pharmacokinetic (PK)     samples in plasma and cerebral spinal fluid (CSF) (matching time) for determination of DTG     concentration will be collected at Week 2 and Week 16. Samples for plasma HIV-1 RNA will be     collected at Baseline and various time points throughout the study and samples for HIV-1 RNA     levels in the CSF will be collected at Baseline, Week 2 and Week 16. Safety, additional     measures of antiviral activity and development of viral resistance will also be evlauated.     The primary analysis will take place after the last subject completes 16 weeks on therapy;     additional analyses will be conducted after the last subject completes Weeks 2 and 96 (end of     study).   "
136416|NCT01499186|"     This randomized controlled intervention study in institutionalized elderly investigates the     effect of 6 months of local vibration therapy applied on the thigh and hip on muscle     strength, muscle mass, bone density, and functionality.   "
136417|NCT01499173|"     Getting to the hospital quickly is the key to treating stroke. African Americans suffer more     strokes with worse outcomes and receive stroke treatments less often than European Americans.     This project will work to reduce these health disparities by creating and testing the     feasibility of a peer-led faith-based behavioral intervention in an African American     community with a goal to increase calls to 911 so stroke patients can be treated quickly.   "
136418|NCT01499160|"     About a third of patients with breast cancer are usually treated by hormone pills called     tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone     production. Female hormone or estrogen is an important hormone for the growth of breast     cancer cells. Letrozole is one of the aromatase inhibitors that is approved by the FDA and     has been used to treat breast cancer since 1997. However, hormone pills usually work for     about 6-10 months in most patients. Later on, breast cancer will start to grow again. This     condition when hormone pills or endocrine therapy no longer work is called endocrine     resistant breast cancer. The scientists here at University of Maryland have discovered how     these cancer cells can become resistant to hormone pills. In our laboratory tests, the     investigators found that lapatinib and everolimus can reverse this resistance and make     letrozole work again. However, it is not known if the drugs can reverse the resistance in     humans.      The purpose of this study is to find out whether the combination of letrozole, lapatinib, and     everolimus is effective in women with breast cancer when hormone pills no longer work.      Lapatinib is an anti-cancer drug that is already approved by the Food and Drug Administration     (FDA). It is the standard of care for the treatment of a particular type of breast cancer     called human epithelial growth factor receptor 2 (HER2)-positive breast cancer. HER2 is a     protein involved in the growth of some cancer cells. This study will also include patients     with HER2-negative breast cancer. This means that the cancer cells in these patients do not     depend on the HER2 protein. The use of lapatinib in these patients is considered     experimental.      Everolimus is also an anti-cancer drug that is approved by the FDA for kidney cancer. Initial     studies in mice and later studies in women with breast cancer have shown that everolimus may     also slow the growth of breast cancer. The use of everolimus is experimental in this study.   "
136419|NCT01499147|"     New conditioning regimens are still needed to maximize efficacy and limit treatment-related     deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past     several years, the investigators have evaluated several new conditioning regimens that     incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has     synergistic activity with alkylating agents. Recent data have suggested that fludarabine may     be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity     previously observed with cyclophosphamide/ busulfan regimens.   "
136420|NCT01499134|"     This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an     active control, metoprolol succinate, in patients with established lower-extremity peripheral     artery disease, hypertension, and at least moderate risk for coronary artery disease.   "
136421|NCT01499121|"     This prospective single arm study will evaluate the efficacy and safety of sunitinib given on     an individualized dosing schedule as first-line therapy in subjects with metastatic clear     cell renal cell cancer. The treatment schedule intent is to maximize dose intensity of     sunitinib and minimize time off therapy based on individual tolerability using protocol     directed dose modification criteria. A total of 110 subjects will be enrolled. All subjects     will continue to receive study treatment until disease progression or withdrawal of consent.     The primary outcome for this study is progression-free survival (PFS), defined as the     duration from the date a patient first receives Sunitinib until the date of death or     confirmed progression according to the RECIST criteria.   "
136437|NCT01498900|"     This study is conducted in Africa and Asia. The aim of this study is to evaluate the     efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes     management in routine clinical practice.   "
137393|NCT01486368|"     This is a non-randomized open label multicentre Phase II trial to evaluate the response rate     of PF03446962 in patients with advanced malignant pleural mesothelioma who have been     previously treated with cytotoxic chemotherapy.   "
136422|NCT01499108|"     Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of     liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential.     The time course and the mechanism behind this effect are unknown.      Objectives: To evaluate the time course of the antihypertensive effect of liraglutide     treatment in patients with type 2 diabetes      Design: Open-label study with intervention and subsequent washout period      Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2     diabetes.      Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and     will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once daily     for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide treatment.      Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV   "
136423|NCT01499095|"     Primary Objective:        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of          change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6)          in adult participants with type 2 diabetes mellitus      Secondary Objective:        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of          occurrence of nocturnal hypoglycemia   "
136424|NCT01499082|"     Primary Objective:        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of          change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with          type 2 diabetes mellitus      Secondary Objectives:        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of          occurrence of nocturnal Hypoglycemia   "
136425|NCT01499069|"     Nerve growth factor (NGF), prostaglandin E2 (PGE2)and adenosine triphosphate (ATP) levels in     urine were reported to increase in patients with overactive bladder (OAB). Also,     administration of the anti-muscarinic agent was reported to decrease urinary NGF and ATP.      The investigators aimed to explore the value of the urinary NGF, PGE2 and ATP as biomarker     for predicting the treatment responsiveness and symptom relapse in OAB patients. So, the     patients can be categorized into responder or non- responder and relapse or non-relapse     groups. Ultimately, they can receive individualized treatments.   "
136426|NCT01499056|"     Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant     problems. First-line of management for patient with osteoarthritis consists of weight     reduction, education, and analgesic medication. If necessary, invasive treatment like total     hip replacement are performed for the patient. The objective of this study was to assess the     safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip     osteoarthritis   "
136427|NCT01499043|"     The main objective of this study is to evaluate the effects on the body that PLX3397 on male     subjects with CRPC.      Secondary objectives include evaluating the safety and tolerability of PLX3397 and the     antitumor effects that PLX3397 has on the the subjects.   "
136428|NCT01499017|"     The primary purpose of this study is to evaluate the safety and tolerability,     pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy     volunteers.   "
136429|NCT01499004|"     This study will explore the drug behavior and safety following a single dose of three     different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy     volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in     an immediate-release formulation.   "
136430|NCT01498991|"     The purpose of this study is to determine if individuals with incomplete spinal cord injury     (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move     the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.      The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete     SCI will result in improved strength, sensation in the legs, and improved functional gait in     the treated limbs.   "
136431|NCT01498978|"     This phase II trial studies how well ipilimumab works when given together with androgen     suppression therapy in treating patients with hormone-resistant prostate cancer that has     spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block tumor     growth in different ways. Some block the ability of tumors to grow and spread. Others find     tumor cells and help kill them or carry tumor-killing substances to them. Androgen can cause     the growth of prostate cancer. Androgen deprivation therapy may stop the adrenal glands from     making androgen. Giving ipilimumab together with androgen suppression therapy may kill more     tumor cells.   "
136432|NCT01498965|"     The Departments of Paediatrics and Child Health, Obstetrics/Gynaecology and Nutritional     Sciences, University College Cork, and the Department of Dermatology, Trinity College, Dublin     have a unique and urgent opportunity to form a birth cohort of over 2000 children whose     growth and maternal health status will have been closely monitored from early pregnancy.     Longitudinal monitoring of these infants will allow direct investigation of several research     areas in a way which has not previously been possible in Ireland, or abroad. The     investigators propose to focus on three main research themes: the effects of intrauterine     growth restriction, the incidence and prevalence of food allergy and eczema in early     childhood and the incidence and effects of maternal and infant vitamin D status on the growth     and health of Irish children. Although the investigators initial proposal will focus on these     important areas, the formation of this birth cohort will offer many opportunities for further     research as the cohort grows older. It will form a unique bio-bank of information from Irish     children collected longitudinally from soon after their conception. The mothers of these     infants are currently being recruited, which leaves us with a narrow window of opportunity to     put in place a pathway of investigation for these children. To ignore this opportunity would     be to lose access to a wealth of information regarding child health and disease. The     potential for this cohort to provide definitive answers to current, and future, theories of     disease causation is enormous.   "
136433|NCT01498952|"     A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard     of care in adult subjects with unresectable or metastatic HCC.   "
136434|NCT01498939|"     This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics     after a single dose of insulin detemir in healthy Chinese male subjects.   "
136435|NCT01498926|"     This trial is conducted in Europe. The aim of this trial is to compare two formulations of     insulin detemir containing an isotonic agent in healthy volunteers.   "
136438|NCT01498887|"     This study will assess the efficacy of fingolimod in patients with short duration     relapsing-remitting multiple sclerosis who have not been previously treated with     disease-modifying therapies (DMTs), versus patients with the same disease duration who have     previously received first-line Disease Modifying Therapies.   "
136439|NCT01498874|"     The purpose of this study is to determine whether gevokizumab is effective in the treatment     of moderate to severe acne vulgaris.   "
136440|NCT01498861|"     Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical     development for the treatment of HIV infection. DTG will likely be used in women on oral     contraceptives (OC) for birth control. Based on accumulated non-clinical and clinical drug     metabolism and pharmacokinetic data, there is a low likelihood of drug interaction between     DTG and most widely used OC drugs. The primary objective of this study is to evaluate the     effect of DTG administration on the pharmacokinetics and pharmacodynamics of a commonly used     oral contraceptive product, Ortho-Cyclen (combination of norgestimate and ethinyl estradiol),     in healthy female subjects. Each subject will participate in a Run-in period (if needed),     followed by two treatment periods. Approximately 16 subjects will be randomized in a     cross-over fashion to either Ortho-Cyclen with DTG or Ortho-Cyclen with Placebo for 10 days     and switch to the alternate treatment for another 10 days. Subjects will return to the study     center for final follow up evaluations 7 - 14 days after the final dose of study medication.   "
136441|NCT01498848|"     We conducted a randomized trial to determine the effect of providing families from Bogota,     Colombia, with a one month supply of one of two cooking oils, sunflower oil vs. soybean oil,     on whole blood and saliva fatty acid composition of children. The aims were: 1) assess the     effect of the oils on whole blood fatty acid composition in children, 2) assess the     correlation between whole blood and saliva to evaluate if fatty acids measured in saliva     would be adequate biomarkers of intake. The study was conducted in the context of an ongoing     cohort study of school children from Bogotá, Colombia (HUM00043252). We conducted an     intervention trial of 4 week duration. Participant families were randomly assigned to either     sunflower oil or soybean oil. Families were visited two times during the 4 week period. We     collected dietary information from the person in the household in charge of food preparation,     and from the child. At the end of the intervention we collected information on whether or not     they liked the oil and whether they would be willing to use it, exclusively, for two years,     to assess acceptability for a longer intervention. We also collected two finger prick blood     samples and two saliva/cheek cells samples from the child, at the beginning and at the end of     the study, to evaluate compliance and to assess the impact of the intervention.   "
136442|NCT01498835|"     To evaluate the toxicity of sunitinib concurrently given with irradiation for preoperative     treatment of locally advanced or recurrent soft tissue sarcoma.   "
136443|NCT01498822|"     To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment     Failure Rate in subjects with newly diagnosed partial onset seizures with or without     secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks     from the first dose   "
136456|NCT01498653|"     A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and     safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once     daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently     treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination     therapy   "
136444|NCT01498809|"     This project aims to evaluate the physiological effects of Midodrine administration during     orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown     to improve orthostatic symptoms in those with spinal cord injury but the physiological     mechanisms influenced have not been identified. The investiagtors will examine key     physiological components influencing orthostatic tolerance. The investiagtors will do this,     by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain     brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one     before Midodrine administration, and one after administration of a 10mg dose of Midodrine.   "
136445|NCT01498796|"     Our group wishes to test the novel hypothesis that intraoperative use of ketorolac in     pediatric patients undergoing tonsillectomy reduces post-operative nausea and vomiting,     postoperative pain scores, subsequent narcotic use, and length of hospital stay without     adversely affecting post-operative bleed risk, when compared to placebo, in a double-blind,     randomized controlled trial.   "
136446|NCT01498783|"     This is a phase I study to investigate the safety and pharmacokinetics of weekly     5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with     recurrent or refractory ependymoma. The results from this study will inform a subsequent     phase II St. Jude investigator-initiated trial.   "
136447|NCT01498770|"     This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK)     during the post-approval period under conditions of usual practice. The use of asenapine in     Bipolar Disorder and other indications will be described. To provide epidemiological and     clinical perspective, use of aripiprazole and other comparator drugs will be described.   "
136448|NCT01498757|"     To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based     chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers     to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to     5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating     tumor cells and circulating endothelial cell precursors and treatment response to     Taxane/5-FU/platinum based chemotherapy.   "
136449|NCT01498744|"     The purpose of this study is to better understand why children develop methicillin-resistant     Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether     antibiotics are helpful after the infection is drained in the operating room.   "
136462|NCT01498575|"     The long-term goal of this research is to increase safe driving among novice teen drivers by     increasing the quantity, quality and diversity of driving practice while accompanied by an     adult. In order to achieve the long term goal of the study, the investigators have developed     a web-based intervention program known as Teen Driving Plan (TDP) intended to support high     quality driving practice.   "
136463|NCT01498562|"     Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may     also assist in overcoming inherent or acquired resistance to gefitinib alone.   "
136450|NCT01498731|"     Acute chest pain is commonly known to be the classic symptom of acute myocardial infarction.     Of the many patients which visit the Emergency Department because of chest pain, less than     half do actually suffer from an acute myocardial infarction or acute myocardial ischemia. In     some patients the acute myocardial infarction can be diagnosed at admission, either because     of typical changes in their ECG (STEMI, ST-elevation myocardial infarction)or because of     increased levels of the laboratory value Troponin in their blood (NSTEMI, Non-ST-elevation     myocardial infarction). Troponin is currently the most important marker to diagnose acute     myocardial infarction. Unfortunately a lot of patients with suspected acute coronary syndrome     do not show any ECG or Troponin changes. These patients pose a major problem in emergency     medicine as they need to precautionally be admitted to a chest pain unit and to be started on     medical treatment until a second Troponin test after 6-9 hours is available.      In this study, we investigate the biomarker Copeptin. Copeptin has shown excellent results in     diagnostic clinical trials assessing its use in various acute diseases. There are three     important trials showing an excellent negative predictive value of Copeptin in combination     with Troponin in patients with suspected acute coronary syndrome (Reichlin et al., JACC,     2009; Keller et al. JACC, 2010, Giannitsis et al. Clin Chem 2011).      This trial compares two processes of managing patients with suspected acute coronary syndrome     (ACS), the standard process according to current guidelines and the experimental process     integrating copeptin as a rule-out marker for acute myocardial infarction into management     decisions. Main Hypothesis: Patients with suspected ACS who test negative for Troponin and     negative for Copeptin at their initial presentation to the ED can safely be discharged     (interventional process). They will not experience more major cardiac adverse events than     patients who were managed by standard practise (control process)within 30 days after     admission.      The Investigators want to test Copeptin in patients with suspected acute coronary syndrome in     whom the ECG is unspecific and the initial Troponin test is negative. Further patient care     will be based on the Copeptin result. Patients with a negative Copeptin will be discharged     into the ambulant care of resident cardiologists.Copeptin positive patients will be managed     according to standard guidelines for the management of patients with ACS.   "
136451|NCT01498718|"     This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years)     adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination     regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza     vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent     inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by     the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human     administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune     response than the seasonal TIV alone.   "
136452|NCT01498705|"     Approximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can     lead to multiple complications including fever that is not infectious. Identifying the cause     of fever can help physicians choose the best care for the patient to try and prevent further     damage to the already injured brain. Bacterial infection is one possible cause of fever in     the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary     antibiotic use. Better screening tools for infection are being developed to help fight the     problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of     antibiotics in patients increases the risk of adverse events and overall healthcare costs.     Procalcitonin (PCT) is one such screening tool which has been used previously to help tell     apart bacterial and nonbacterial causes of infection in other disease states; however, PCT     has not been studied in hemorrhagic stroke patients. The purpose of this study is to     understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT can     be a useful marker for infection in these patients.   "
136453|NCT01498692|"     The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™     Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo     atherosclerotic coronary artery lesions. The lesions can be located in vessels that are     smaller than average-sized.   "
136454|NCT01498679|"     A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate     the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation     powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult     subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid     or low-strength combination therapy.   "
136455|NCT01498666|"     The present clinical trial will examine the use of L. reuteri Protectis in children with     functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri     Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis     of functional abdominal pain (FAP).   "
136458|NCT01498627|"     This study aims to assess whether the use of Cervarix® is associated with a modified risk of     central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis,     idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis,     Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx     information system.   "
136459|NCT01498614|"     Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes:     Intervention Study With Affect School and Basal Body Awareness      Background:      Depression is common in patients with diabetes and is associated with impaired metabolic     control. Alexithymia has been associated with depression, anxiety, stress related disorders     and diabetes mellitus. Affect School (AS) is an intervention that may reduce depression and     alexithymia according to previous research. Basic Body Awareness Therapy (BBA) is a     stress-reducing technique.      Purpose:      Our aim is to: 1. Analyze the prevalence of depression and anxiety and the personality     variables alexithymia and self image in diabetes patients. 2. Explore correlations between     these variables and risk factors, including biochemical markers for diabetic complications.     3. To evaluate an intervention with AS and BBA in patients with diabetes that scored high in     psychometric self-report tests and at the same time showed impaired metabolic control.      Method:      A randomized controlled trial of 350 people with diabetes, 18-59 years, 56% men, 44% women.     Base-line study: from medical records and the National Diabetes Registry - waist     circumference, BMI, blood pressure, type and duration of diabetes, diabetes complications,     other diseases, medications, exercise habits and smoking. Tests - A1c, blood lipids,     cytokines, hormones, beta-cell antibodies, c-peptide, midnight cortisol (salivary).     Self-report tests of psychological and personality variables: HAD, TAS-20, SASB.     Intervention: patients with A1c ≥ 8 and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative     self-image (SASB: AFF <284) or alexithymia (TAS-20 ≥ 61) were randomized to AS or BBA. AS: 8     group sessions followed by 10 individual sessions. Instructors were a primary care physician     and a psychotherapist. BBA: 9 group meetings and 6 individual sessions with a physiotherapist     as instructor. Post intervention: Self report tests, A1c, cytokines, hormones, cortisol.   "
136460|NCT01498601|"     Hypothesis: The investigators hypothesize that the current oral protocol is sub-optimal and     an enhanced protocol will decrease the incidence of hospital acquired pneumonia (HAP)in the     acute, non-intubated, care-dependent, neurologically impaired, adult patient.   "
136461|NCT01498588|"     Previous studies have shown that chemotherapy has the same effect on treating breast cancer     whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather     than after surgery, may allow the patient to have less extensive surgery. The purpose of this     study is to identify new treatment regimens with better response rates and to find out if the     combination of eribulin followed by doxorubicin and cyclophosphamide can shrink the size of     the patient's breast tumor and allow you to preserve your breast. Additionally, by receiving     chemotherapy before surgery, the investigators will be able to determine if your cancer is     responsive to chemotherapy.   "
136464|NCT01498549|"     The overall goal of this study is to determine if atomoxetine treatment improves selective     cognitive functions in abstinent cocaine users, compared to healthy controls. The study will     also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates     the cognitive effects of atomoxetine.   "
136465|NCT01498536|"     This study seeks to see if a 12-week diet and exercise program improves exercise ability,     energy level, and quality of life.   "
136466|NCT01498523|"     Rationale: Recently, human, animal and epidemiological studies suggested that camel milk has     a hypoglycaemic activity. However, a mechanism and reasons for this activity have not been     sufficiently studied. Therefore, a study on a glycaemic and insulinaemic responses of regular     camel milk and camel milk powder is needed.      Objective: To explore the glycaemic and insulinaemic responses of regular camel milk and     camel milk powder in healthy adults.      Study design: In a randomised, single-blind and cross over design, two hour post prandial     glucose and insulin responses of 4 treatments (regular camel milk, camel milk powder, regular     cow milk and glucose) will be measured . Those treatments will be consumed in a portion that     contained 25g available carbohydrate. Finger-prick capillary blood samples will be taken at     fasting, and 15, 30, 45, 60, 90, 120 minutes after ingestion of the test product.     Venepunctures will be taken at fasting, 30 and 75 minutes after ingestion of the test     product. The measurements will be conducted on 4 separate days with at least 2 days wash out.      Study population: 20 healthy volunteers aged 18 to 35 years, with BMI between 18.5 to 25     kg/m2.      Intervention: The treatments are regular camel milk, camel milk powder, regular cow milk and     glucose. These are standardized to 600ml containing 25g available carbohydrate.      Main study parameters/endpoints: Main parameters are postprandial blood glucose and insulin     responses. Secondary parameters: amino acid composition and glycemic index.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: This intervention is non-therapeutic to the subjects. The risk associated with     participation is negligible and the burden can be considered low. Before subjects are able to     participate in this study they will have to fill out a brief questionnaire, and have their     fasting blood glucose measured, in order to ensure they fit the inclusion criteria of the     study. Once entering the study, each subject will have to visit the research centre 4 times     for the postprandial tests. On each measurement day, each subject will be required to have     fasted for at least ten hours before (an overnight fast). Each subject will have 7     finger-prick blood samples and 3 venapunctures taken during each visit. A maximum amount of     50 ml blood is drawn per day.   "
136467|NCT01498510|"     The purpose of this study is to develop and evaluate an innovative, web-based self-management     intervention for opioid-treated chronic pain patients who display aberrant drug-related     behavior.   "
136468|NCT01498497|"     This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse     events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after     discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of     Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity     to better understand the natural course of eosinophilic esophagitis and define the treatment     modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic     maintenance or intermittent treatment.      All subjects who complete PR-021 will be offered the opportunity to participate in this     study. The duration of this follow-up study is six months, during which subjects will visit     the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8,     Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week     20.   "
136469|NCT01498484|"     This is a Phase II trial to evaluate the efficacy and safety of human leukocyte antigen (HLA)     partially-matched third-party allogeneic Epstein-Barr virus cytotoxic T lymphocytes     (EBV-CTLs) for the treatment of EBV-induced lymphomas and EBV-associated malignancies.   "
136500|NCT01498081|"     This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115     will be tested versus placebo and active comparators. The safety and tolerability of AZD2115     including investigations of clinically relevant systemically mediated effects will also be     investigated.   "
136470|NCT01498471|"     This study is designed to evaluate the accuracy of the National Institute for Health and     Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short     term serious outcome when presenting in the emergency department (ED) with Transient Loss of     Consciousness (TLoC). Red flags were defined as ECG abnormality, history or physical signs of     heart failure, TLoC during exercise, family history of sudden cardiac death at an age < 40     years and/or an inherited cardiac condition, new or unexplained breathlessness, heart murmur,     absence of prodromal symptoms in any patient aged > 65 years.   "
136471|NCT01498458|"     Angiogenesis is essential for the growth of large tumor. A number of anti-angiogenic agents     are currently under development. Bevacizumab, a humanised monoclonal antibody to vascular     endothelial growth factor (VEGF), has been shown to improve disease free survival in first     line metastatic breast cancer when associated with chemotherapy 1. Results of a randomised     phase II trial combining sorafenib, a tyrosine kinase inhibitor targeting multiple tyrosine     kinases including VEGFR1, VEGFR2, VEGFR3, with capecitabine have recently been reported 2.     Compared to capecitabine plus placebo, progression-free survival in the capecitabine +     sorafenib arm was significantly increased from 4.1 months to 6.4 months. Toxicities were also     increased, with an incidence rate of grade 3/4 hand foot syndrome of 45% in the capecitabine     + sorafenib arm compared to 13% in the capecitabine + placebo arm. The increased toxicity     will most likely limit the clinical use of this regimen.      Pazopanib is a potent, multi-targeted TKI of VEGFR-1, -2, -3, PDGFR-α and -β and c-kit and     has recently been approved for the treatment of renal cell cancer in the U.S. In the EU, a     positive opinion has been issued by the European Medicines Agency.      A phase II study of GW786034 (pazopanib) in patients with recurrent or metastatic invasive     breast carcinoma included 19 patients after a maximum of 2 lines of chemotherapy for advanced     disease 3. Pazopanib 800 mg daily was given continuously.      A clinically significant rate of stable disease (58%) was detected with a median TTP of 5.3     months (95% CI: 1.8 - 9.0 months). Four patients treated with pazopanib had SD for ≥ 6     months, for a clinical benefit rate (CBR), defined as rate of SD for ≥ 6 months or CR or PR,     of 5/19 (26%), which is at least comparable to sunitinib and bevacizumab (CBR 16% and 17%,     respectively).      The pivotal study of full dose (800 mg) daily pazopanib in renal cell cancer reported hand     foot syndrome of all grades in only 6% of patients 4. The optimally tolerated regimen (OTR)     of pazopanib was determined when administered in combination with capecitabine and     oxaliplatin in patients with advanced CRC 5. In patients who received capecitabine (850 mg     twice daily) plus 800 mg once daily pazopanib combined with oxaliplatin, the incidence of     hand foot syndrome of all grades was 24%.      The present study will investigate the combination of pazopanib and capecitabine in advanced     or metastatic breast cancer with the aim to develop a new treatment option with increased     efficacy and tolerability.   "
136472|NCT01498445|"     The goal of this clinical research study is to learn if combining Sprycel (dasatinib) and     Dacogen (decitabine) can help to control CML. The dose level of decitabine will also be     studied.      Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia.      Decitabine is designed to affect the mechanism that cells use to control the expression of     certain genes, some of which are important in the progression of CML.   "
136473|NCT01498432|"     This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The     fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas     delivery in patients who require non-invasive ventilatory support following extubation on the     Intensive Care Unit. Thus, the investigators aim to extend our knowledge of the potential     role for Heliox21 in the post-extubation environment of the Intensive Care Unit. The purpose     of this study is to answer a specific, clinically relevant question. That is whether Heliox21     helps to reduce the effort of breathing in the period following withdrawal of mechanically     assisted ventilation in patients on the intensive care unit.   "
136476|NCT01498393|"     The purpose of this clinical study is to improve the appearance of onychomycosis and     morphology of the nail (fungal infection). The researcher can use a light based therapy to     gently heat the toenail infected with fungus to improve the appearance of onychomycosis.   "
136477|NCT01498380|"     Dexmedetomidine is a sedative drug that has many benefits when given to children under     anesthesia, such as improved pain relief and reduced agitation following their surgery. It is     usually given as an intravenous infusion over 10 minutes, to avoid the changes in heart rate     and blood pressure that are occasionally seen when it is administered more quickly. However,     this is often infeasible and usually inconvenient. The investigators aim to determine the     dose of dexmedetomidine that can be given rapidly (over 5 seconds) without causing     significant changes in heart rate and blood pressure. This will be the only study specific     intervention.   "
136478|NCT01498367|"     To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified,     centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and     whether this intervention produces health and economic benefits when introduced without major     changes to the existing organization of a large tertiary care center.   "
136479|NCT01498354|"     Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is     anterior resection of the rectum or abdominoperineal resection. These techniques are     associated with high mortality and morbidity and with genitourinary dysfunctions.      To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its     3-D vision system using a rectoscope, this procedure allows access to rectal tumors located     up to 20 cm from the anal verge. It is associated with minimal morbidity and has few     repercussions for anal continence.      The use of 2-D high definition cameras and screens obtains images of a similar quality to 3-D     images. This means that from the surgical point of view the procedure known as TEO (transanal     endoscopic operation) seems as practicable as classic TEM.      Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus     conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical     facility, postoperative morbidity, quality of the surgical specimens, and cost.      Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high     definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery.      Disease studied: Rectal adenomas and adenocarcinomas in situ suitable for local surgery.      Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal     postoperative morbidity.      Study population and total number of patients: Patients diagnosed with rectal tumor treated     with curative intent (rectal adenomas and adenocarcinomas in situ). The total sample     calculated for the trial was 36 patients, 18 in each group (TEO and TEM).      Timing and expected finish date: After approval by the CEIC, the expected date for the     inclusion of the first patient was August 2010. The study is expected to last 18-24 months.   "
136480|NCT01498341|"     The purpose of this study is to identify the number of persons in Denmark with the diagnose     hypoparathyroidism, autosomal dominant hypocalcaemia or pseudohypoparathyroidism. Also the     investigators want to identify the causes and symptoms of these patients and their prognosis.   "
136481|NCT01498328|"     The purpose of this research study is to find out whether adding an experimental vaccine     called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve     progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII     positive glioblastoma.   "
136501|NCT01498068|"     The purpose of this study is to determine the effectiveness, safety and tolerability of     telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated     interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced     Russian participants with genotype 1 chronic hepatitis C.   "
136482|NCT01498315|"     Hysterectomy is one of the common operations in gynecology. With population aging in modern     society, the incidence of these surgeries is expected to increase even more. One of the major     complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain,     fever, and foul smelling discharge. The incidence of pelvic hematoma is 40%, and varies     according to the type of hysterectomy and the diagnostic procedure. Those hematoma increase     the risk for infection. Diagnosis usually is not a clinical one unless symptoms occur, and     then the diagnosis is made by CT or ultrasound. Number of interventions are mentioned in the     literature to try and decrease post operative complications and infections, none have     suggested effective enough. This is a prospective study which objective is to characterize     the incidence of pelvic hematoma following hysterectomy using ultrasound. The investigators     will also try to identify preoperative, intraoperative and postoperative risk factors for     infection of this hematomas. This identification might decrease the incidence of     postoperative hematoma and infection.   "
136483|NCT01498302|"     RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease     will come back in patients diagnosed with acute myeloid leukemia.      PURPOSE: This research trial studies the comparison of laboratory test results for minimal     residual disease in samples from patients with acute myeloid leukemia.   "
136484|NCT01498289|"     RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil,     irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor     cells, either by killing the cells or by stopping them from dividing. Combining more than one     drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy     is more effective in treating tumor cells.      PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and     fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients     with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.   "
136485|NCT01498276|"     Background:      - Family-based approaches to reduce disease risk and promote healthy behaviors may be better     than targeting individuals. Risk assessments based on family health history may help educate     families on disease risks and encourage them to change physical activity and food choices.     Specifically, researchers want to better understand the role of mothers in teaching healthy     behaviors to their families.      Objectives:        -  To determine mothers influence on diet and health-related behaviors.        -  To study an intervention tool that connects family health history and disease risk.      Eligibility:      - 18 years of age who have at least one child living at home.      Design:        -  Participants will complete a survey over the phone. The survey will take 30 to 40          minutes to complete. The survey will collect family health history on heart disease,          diabetes, colorectal cancer, and breast cancer.        -  Researchers will give participants a Family Health Package (FHP). The FHP will provide          information on family health history and disease risk. It will also recommend behaviors          that can reduce health risks.        -  Two weeks after sending the FHP, participants will complete a phone survey about the FHP          materials and their social networks.        -  Some participants will be invited to focus groups. The focus groups will explore diet          and health behavior. They will look at food purchasing and preparation and meal sharing.          The groups will also discuss attitudes toward healthy eating and physical activity. Each          focus group will last 1 to 2 hours.        -  Participants will be asked to complete an electronic survey regarding participants          health status, causal health beliefs, risk perceptions, and intentions to communicate          health information.        -  Then, participants will have the opportunity to use the electronic version of the FHP,          which will assess family health history.        -  After using the FHeP, participants will complete a short electronic survey to identify          knowledge and understanding gained from the use of the application, changes in          communication intentions, and suggestions for improvements to the application.        -  Upon completion of the electronic portion of the study, a study team member will conduct          a semi-structured interview to allow the participants to qualitatively evaluate their          user experience, including satisfaction and usefulness.        -  This study process will take approximately 60-90 minutes.   "
136486|NCT01498263|"     Approximately 66 million informal caregivers care for someone who is ill, disabled, or aged.     These caregivers experience significant distress associated with caregiving, which may be     particularly salient in the context of inherited conditions. Previous studies have not     examined caregiving from a network perspective, nor have they considered how cognitive and     emotional responses, such as caregivers worry for themselves and relatives acquiring the     disease or guilt related to the genetic etiology of their child s illness, as possible     stressors; the current project fills this literature gap.      Caregiving processes may vary across type of illness and the life course. In illnesses that     impact children, parents and grandparents may take on caregiving roles whereas in conditions     that impact adults, spouses and adult children may provide care. Caregivers must adapt to the     strain of caring for their affected relatives and this adaptation may differ depending on     caregiver roles. The caregiver s support network may influence adaptation, impacting the     health and well-being of patients, their caregivers, and other relatives.      This project, comprised of 4 substudies, will examine social contexts surrounding families     involved in caring for individuals with chronic inherited conditions from a relational     perspective. Surveys and interviews will assess participants cognitions and emotions about     the disease, caregiving burden and caregiving/support network systems. In addition,     biomarkers will be considered in 2 substudies to examine how caregiving roles and     expectations impact health among caregivers.      We aim to recruit at least 3100 participants through residential/daycare centers, advocacy     groups, and the NIH Clinical Center. We will recruit formal caregivers, multiple biological     and non-biological adult relatives of patients and normally developing controls to construct     and evaluate caregiving/support network systems. This project will use a social network     framework to develop and adapt common measures of caregiving roles to evaluate burden,     perceptual bias, and unmet expectations in caregiving. The psychometric properties of these     new measures, characteristics of family caregiving and support networks, and how these     network characteristics are associated with caregiving strain and well-being, including     biomarkers of physical health, will be investigated. The moderating role of family members     cognitions and emotions and disease context will be considered. Findings will guide future     research to develop network-based interventions promoting positive adaptation to the presence     of inherited conditions in families through improved social environments and coping skills.   "
136487|NCT01498250|"     Perturbations in microRNA (miRNA) expression profiles has been reported for a variety of     cancers. This study will be an exploratory analysis of miRNA expression in basal cell     carcinoma by miRNA expression profiling using microarrays.   "
136488|NCT01498237|"     The purpose of this research study is to evaluate whether a new technology called     intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the     uterus.   "
136489|NCT01498224|"     This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure     Sealant compared to sutures for preventing incision leakage within the first 7 days of     cataract surgery.   "
136490|NCT01498211|"     Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this     density is used to diagnose small fiber neuropathy, despite the absence of normative data in     a selected normal population. To establish a normative set of data matched for age and sex is     absolutely needed to evaluate the sensibility and specificity of this test.   "
136502|NCT01498055|"     To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung     cancer.   "
136522|NCT01497782|"     With a worldwide proliferation of simulation centers, it is essential to explore the optimal     setting for laparoscopic training and investigate different learning approaches, e.g. a     self-directed approach. Therefore, the researchers investigated the following in a randomized     controlled trial: the impact of instructor feedback vs. an independent, self-directed     approach when training a complex operational task on a laparoscopic virtual reality     simulator.      The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when     training on a virtual reality simulator.   "
136491|NCT01498198|"     The overall goal of this proposed randomized study is to determine if surgery at the time of     diagnosis or rehabilitation +/- surgery (i.e. surgery only when rehabilitation fails) results     in shorter times to claim closure. The study will examine how often non-operative management     is successful in resolving symptoms and allowing subjects to return to work without surgery.     The investigators will also examine if there are subject, tear or work-related     characteristics that affect the outcome of rehabilitation or expedited surgery and predict     whether patients should be referred to operative or non-operative management at time of     assessment. At study completion, the investigators expect to be able to definitively state     the best management for subjects with these less serious RC tears.      The specific research questions to be addressed are as follows:        1. In WCB subjects with high grade partial thickness (>50%) or small full thickness (≤ 1          cm.) rotator cuff tears, how does non-operative management (i.e. rehabilitation) or          expedited surgery affect time to claim closure?        2. Are there subject, tear or work-related characteristics that affect which patient          management approach will be most effective and efficient?   "
136492|NCT01498185|"     To obtain safety and tolerability information in patients with type 1 diabetes where     Dapagliflozin is added on to Insulin (for 14 days)   "
136493|NCT01498172|"     In this study, the investigators would like to assess how intravesical BCG schedules after     immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together     with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell     responses both systemically and locally in the bladder.   "
136494|NCT01498159|"     This research evaluates a diabetes management intervention designed to improve medication     adherence and intensify therapy to reach goals in blood sugar, blood pressure, and     cholesterol levels. This study will determine the benefit and cost of adding community health     promoters to pharmacist disease management services. If there is benefit, then this approach     may help reduce the burden of diabetes and its related complications among minorities with     diabetes.   "
136495|NCT01498146|"     The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous     unexplained stroke. It uses long term monitoring of the heart of up to three years, searching     for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.   "
136512|NCT01497925|"     This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors     with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize     that the combination will result in greater tumor cytotoxicity with an acceptable toxicity     profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of     action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20     and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that     this will be particularly relevant in CRPC.   "
136542|NCT01497522|"     The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as     an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted     to support registration of the fixed-dose combination of vildagliptin and metformin for the     treatment of Type 2 diabetes mellitus (T2DM) in Japan.   "
136543|NCT01497509|"     Although intrapartum epidural analgesia is frequently implicated in adverse breast-feeding     outcomes, many previous studies feature major design limitations that preclude widespread     applicability of findings. Some fail to control for the precise pharmacologic composition of     the epidural infusion, including whether or not an opioid, such as fentanyl, is even used at     all in addition to local anesthetic or whether a combined spinal/epidural or purely epidural     technique is used. The drugs used in epidural infusions not only have different mechanisms of     action and lipophilicities but are also transferred across the placenta in varying     proportions, with one study identifying an umbilical vein/maternal vein ratio of 0.94 for     epidural fentanyl and 0.30 for bupivacaine, and another finding significantly different     umbilical cord fentanyl concentrations among neonates whose mothers' epidural infusions     contained >150 micrograms fentanyl, <150 micrograms, or none at all. It is also possible that     the same total dose of epidural fentanyl could affect neonates differently depending upon the     time course over which it was administered - namely, whether fentanyl is included in both the     initial epidural bolus and the subsequent infusion or solely in the infusion. In two studies,     mean umbilical vein concentrations of fentanyl did not correlate with total epidural infusion     time, but both of these featured sample sizes fewer than 30, necessitating further research.     Another limitation of some previous studies is defining success solely as the time to     cessation of breast-feeding. Questionnaires mailed to mothers months or even years postpartum     may generate unreliable data. If epidural medications truly mediate some physiologic effect     upon breast-feeding, then the optimal study period is immediately post-delivery, specifically     before the drugs are cleared from the maternal and neonatal circulations. After hospital     discharge, many new factors - such as a mother's need to return to work or lack of social     support - begin to confound the picture of breast-feeding success. Full-time employment     outside the home has been significantly associated with decreased likelihood of     breast-feeding at 6 months postpartum. Some studies also fail to control for intent to     breast-feed at the time of hospital admission, number of infants previously breast-fed, or     labor duration. Failure to account for oxytocin augmentation of labor is also problematic, as     intravenous intrapartum oxytocin infusion has been shown to decrease a woman's endogenous     serum oxytocin concentration on the second day postpartum in a dose-dependent fashion, which     can subsequently impair milk release and, thus, decrease breast-feeding success.      Epidural analgesia may worsen breast-feeding outcomes by attenuating neonatal exhibition of     neurobehaviors tied to feeding, such as sucking, rooting, and swallowing, during the     immediate postpartum period. This critical period is when mother and baby make their first     attempts at breast-feeding and set a precedent for subsequent interactions. Neonatal feeding     behavior in the early postpartum period is an important predictor of long-term breast-feeding     success; those babies who feed most vigorously during their first days of life are     significantly more likely to still be breast-feeding at 3 or 6 months than those who exhibit     any lesser degree of breast-feeding enthusiasm. Radzyminski et al. found no significant     dose-response relationship for either epidural bupivacaine or fentanyl regarding neonatal     feeding behaviors, and Porter et al. found no significant effect of epidural fentanyl, mean     dose 184 micrograms, upon neonatal APGAR scores, incidence of respiratory depression, or NACS     scores (Neurologic and Adaptive Capacity Scores) at 2 or 24 hours post-delivery. Beilin et     al. found that neonatal NACS scores were significantly lower when mothers' epidural infusions     contained greater than 150 micrograms total epidural fentanyl than when they contained only     bupivacaine.      In this randomized, controlled, double-blinded study, we investigate whether intrapartum     epidural fentanyl significantly decreases the likelihood of breast-feeding at hospital     discharge and increases the incidence of neonatal deficits in latching on to the breast and     audibly swallowing during the first three hours of life. We hypothesize that these effects     will be dose-dependent but will have no relation to the time course over which the epidural     fentanyl is administered. We also investigate whether oxytocin augmentation of labor and     decreased amount of skin-to-skin contact during the first hour of life are associated with     significantly decreased breast-feeding rates at hospital discharge.   "
136496|NCT01498133|"     BACKGROUND Decolonization with topical antibiotics is necessary to prevent and / or control     outbreaks of multidrug-resistant bacterial infection in the NICU (Neonatal Intensive Care     Unit), but can trigger bacterial resistance. The objective of this study was to determine     whether skin-to-skin contact of newborns colonized with MRSA (Methicillin-Oxacillin Resistant     Staphylococcus Aureus) with their mothers could be an effective alternative for biological     control of bacterial colonization.      METHODS: The investigators studied 102 newborns admitted to NICU in three public hospitals in     São Luís, Brazil. Inclusion criteria were birth weight from 1300 to 1800g, length of stay >4     days, newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative     methicillin-oxacillin resistant and mothers not colonized by these bacteria. Randomization     was performed using a computer generated random numbers algorithm. Allocation to intervention     and control groups was performed for each eligible newborn using a sealed opaque envelope. In     the intervention group (n = 53) mother-infant skin-to-skin contact was held twice a day. The     control group (n = 49) received routine care without skin-to-skin contact. There was no     masking of newborn's mothers or researchers, but the individuals who carried out bacterial     cultures and assessed results were kept blind to group allocation.      The primary outcome was decolonization of newborns' nostrils after 7 days of intervention.     Safety was assessed by monitoring vital signs of newborns during the intervention. The     secondary outcome was emergence of late onset presumed sepsis until the end of     hospitalization period or 28 days of life, whatever happened first.      FUNDING: CNPq (Brazilian Research Council) and FAPEMA (Maranhão Research Foundation)   "
136497|NCT01498120|"     This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up     study of monotherapy administration of rotigotine transdermal patch in adolescents with     Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of     Rotigotine treatment in adolescents with RLS.   "
136498|NCT01498107|"     This pilot study investigates a new platform for supporting online interventions for common     mental health problems called SilverCloud. It was developed from insights into interactive     system design to address the problem of high attrition rates and poor engagement with online     interventions. Through a range of methods, the study considers the role of four design     strategies in engaging users in cognitive behavioural therapy. A service-based study, it     concentrates on a clinical population with mild or moderate depression. Clinical outcome     measures will be taken pre and post intervention use; demographic data of who did and did not     choose the intervention collected, patterns of usage will be extracted from the log data and     analysed; and qualitative interviews will be done to understand the relationship between     patterns of usage and levels of engagement. The findings will be used to inform further     developments of this and other online interventions and contribute to the development of     methods for assessing online interventions.      The objectives of the pilot study are:        -  To evaluate engagement with the online intervention in a realistic primary mental health          care setting        -  Assess engagement from multiple perspectives, including clinical efficacy and          interaction design        -  Contribute to further development of the online intervention        -  Support preparation for a full-scale clinical trial      Research questions include:        -  Does the online intervention decrease symptoms of depression?        -  Who chooses to use the online intervention?        -  What are the patterns of use of the online intervention?        -  How successful are the four design principles, personal, interactive, supportive and          social, in supporting engagement?   "
136499|NCT01498094|"     Bronchiolitis is a common illness of the respiratory tract caused by infection of the tiny     airways within the lungs called bronchioles. At present the standard care of hospitalized     children with bronchiolitis is oxygen via nasal prongs. In this study the investigators would     like to compare standard ward management with a new method of delivering oxygen called high     flow nasal cannula oxygen therapy (HFNOT). HFNOT involves breathing warmed, moistened oxygen     through nasal cannulae at a flow rate of 8 liters/minute. Accumulated experience suggests     that HFNOT eases the child's work of breathing and reduces need for ICU admission and     invasive respiratory support.   "
136503|NCT01498042|"     Stroke is among the most disabilitating diseases worldwide in terms of numbers affected and     its consequences. A relatively new and well documented treatment of acute ischemic stroke     today is tPA (tissue plasminogen activator; will be called thrombolysis from now on)     Unfortunately only a minority of patients is given this treatment.      The large randomised controlled trials that investigated the safety and efficacy of     thrombolytic therapy in treatment of acute stroke did not include patients over 80 years. In     an aging population in the western world it will be of importance to investigate whether this     treatment is safe and effective in this group.      Both Sorlandet hospital Kristiansand Norway and Bergen hospital have administered     thrombolysis to selected patients over 80 years the last years. In addition there has been a     registration of patients in stroke registers at both locations. This lays a foundation for     further investigation. In association with Bergen the investigators have included 77 patients     over 80 years treated with thrombolysis. In addition the investigators have 85 patients     treated with tpa below 80 years. In our cohort the investigators are going to compare outcome     in the 2 groups. In addition the investigators are going to perform a regression analysis of     selected variables to see if there is an association of those variables with predefined     outcome measures. Our outcome measures is as follows: mRS=6 (death)and mRS 0-1(good outcome)     on 3 months control. The third outcome measure will be developement of sICH secondary to tPA     treatment. As definition of sICH we have chosen the same definition as Ecass.   "
136513|NCT01497912|"     Patients with type 1 diabetes are at increased risk of vascular complications both in the     micro- and macrocirculation. Hyperglycemia plays a major role in the development of these     vascular complications, but other factors such increased platelet adhesion and aggregation,     elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin     generation, dyslipidemia and endothelial dysfunction may contribute.      Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in     individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and     vasculature that are independent of their lipid-lowering properties.      The aim of the present study was to investigated the effects of intensive     LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary     variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia.     Furthermore, the effects of atorvastatin therapy on skin microvascular function was also     investigated.   "
136504|NCT01498029|"     The Cartilage Autograft Implantation System (CAIS) is a single-stage procedure in which     cartilage is harvested from non-critical regions of articular cartilage, but then immediately     morcellated and loaded onto a polymer membrane-scaffold, which is subsequently used to fill     the chondral defect. The autograft-membrane composite is fixed to the defect with a     biodegradable staple.      The investigators aim to evaluate this new technique through a pilot clinical trial involving     36 patients randomized into microfracture and CAIS treatment arms (randomisation ratio 1:2),     with a minimum follow-up of 1 year, using both clinical and radiological (magnetic resonance     imaging) outcomes. If the results of this pilot trial are successful, the investigators plan     to expand the study by recruiting more patients to achieve a suitably-powered trial.      Primary hypothesis 1: That functional scores will increase by at least 0.5 SD over     pre-operative values, by 1 year following the CAIS procedure      Primary hypothesis 2: That articular cartilage height will have a sustained increase of at     least 2 mm at 1 year following the CAIS procedure      Primary hypothesis 3: That functional scores in the CAIS group will be equivalent or superior     to those in the microfracture group   "
136505|NCT01498016|"     Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic     hematopoietic stem cell transplantation for patients with acute leukemia. Though the     pharmacokinetics data are available for population from America, Europe and Japan or Korea in     Asia, there are no data in Chinese population. It is shown that high Bu concentration are     associated with the toxicity such as veno-occlusion disease and lower concentration is     correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy     to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain     the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct     the pharmacokinetic study in Chinese population.   "
136506|NCT01498003|"     Periprocedural myonecrosis or infarction are associated with short, intermediate, and long     term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural     CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the     investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence     of periprocedural infarciton in elective patients with long coronary lesions treated by     overlapping use of drug-eluting stents.   "
136507|NCT01497990|"     This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT)     burn patients.   "
136508|NCT01497977|"     The goal of the study was to assess the impact of soy and red clover derived phytoestrogens     on serum lipids in postmenopausal women. Both soya and red clover have high phytoestrogen     content. Phytoestrogens, a class of estrogenic molecules produced by plants bind to the     estrogen receptor and are capable of producing estrogenic effects. Therefore, our hypothesis     was that they can reduce the levels of serum lipids.      Materials and Methods: Researchers investigated total cholesterol, cholesterol fractions and     triglycerides in blood, before treatment and in six months periods, throughout 18 months. The     study involved 74 healthy postmenopausal women, divided into three groups. The first group of     23 patients received red clover derived isoflavones, the second one with 26 patients got soy     derived phytoestrogens, while the third, control group with 25 patients, was without     medications.   "
136509|NCT01497964|"     Primary Objective:      - To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response     rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in     patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens      Secondary Objectives:        -  To determine the RD of cabazitaxel when administered as a single agent every 3 weeks        -  To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks        -  To estimate the overall survival (OS) and progression free survival (PFS)        -  To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1   "
136510|NCT01497951|"     Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to     re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical     removal is not always possible. The photodynamic therapy uses a special substance, which is     absorbed in cells, and thereafter activated by a defined light. The aim of this study is to     compare the photodynamic therapy in potentially malignant lesions to a placebo. The     investigators assume a significant better result in photodynamic therapy then treatment with     a placebo.   "
136521|NCT01497808|"     The primary objective is to determine the maximum tolerated hypofractionated radiotherapy     dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in     metastatic melanoma patients without brain involvement The secondary objectives are to     determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes     after hypofractionated radiotherapy followed by ipilimumab   "
136523|NCT01497769|"     This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine     MVA85A administered by the aerosol inhaled route and the intradermal route in healthy     BCG-vaccinated adult subjects.   "
136511|NCT01497938|"     Introduction:      The purpose of the pivotal In Home study is to collect clinical data on the safety and     efficacy of the Paradigm LGS System in the actual use environment and by the intended use     population. ASPIRE is a multi-center, in home, randomized parallel adaptive study design with     type 1 diabetes. The study will compare A1C and CGM based nocturnal hypoglycemic events in a     treatment arm to a control arm. Arms are defined as:        -  Treatment Arm (LGS ON) using Paradigm® VEO™ Pump        -  Control Arm (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump      The study's objectives are two-fold:        1. The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS)          is safe and is not associated with glycemic deterioration, as measured by change in A1C          from baseline to end of study participation.        2. The second study objective is to demonstrate that home use of Low Glucose Suspend (LGS)          is associated with reduction in nocturnal hypoglycemia when patients fail to respond.      Primary Safety Endpoint:      The change in A1C from randomization to the end of the treatment period will be used to     demonstrate that the automatic insulin delivery suspension (LGS ON) does not result in an     unacceptable worsening of glycemic control.   "
136514|NCT01497899|"     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir     alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)     FDC in HIV-1 infected, antiretroviral treatment-naive adults.   "
136515|NCT01497886|"     Despite the abundance of stroke education materials available, studies continue to reveal     severe deficiencies in stroke literacy (knowledge of symptoms, urgent action, and prevention     measures). Expensive mass media stroke education campaigns are not sustainable for this     purpose, particularly in economically disadvantaged populations. Instead, the investigators     propose to intervene in school classrooms with children aged 9 to 11 years, to teach the five     cardinal stroke symptoms, the correct course of action when they occur, and to highlight the     potential therapeutic benefit of early hospital arrival, with the intent that the children     will then educate their parents. To help accomplish this, the investigators have developed a     program called Hip Hop Stroke (HHS), which is comprised of rap songs and two animated musical     cartoons that incorporate stroke knowledge.      Hypotheses:      Hypothesis 1. No differences in baseline knowledge will exist between the parents assigned to     the intervention and control arms or between the children assigned to the intervention and     control arms.      Hypothesis 2. Children in the intervention arm will demonstrate greater knowledge immediately     after and at three months after the intervention concerning stroke symptom identification and     response compared to those in the control arm.      Hypothesis 3. Compared to students in the Control condition, children in the intervention arm     will be more likely to communicate stroke information to their parents (assessed at 1-week     follow-up).      Hypothesis 4. In homes in which such communication has been enacted, parents in schools     assigned to the intervention arm will demonstrate greater ability to name the symptoms of     stroke and appropriate action, compared to their baseline knowledge, at 1 week and at 3     months follow-up, compared to parents in the control arm.   "
136516|NCT01497873|"     The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5     days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung     cancer.   "
136517|NCT01497860|"     The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink     or slow the growth of pediatric low-grade gliomas that have either returned or are continuing     to grow.      Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in     patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its     therapeutic spectrum and decrease the neurotoxicity associated with related agents.   "
136518|NCT01497847|"     Purpose:        -  identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome          (PI-IBS) development after an episode of traveler's diarrhea        -  identification of systemic (serum) and local (biopsy) changes in infectious and          immunological activity during infection and correlation with Irritable Bowel Syndrome          (IBS) symptoms, persisting after traveler's diarrhea      Design:        -  4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12          months after traveling        -  at each study visit following investigations: blood collection, stool collection,          questionnaires, rectal biopsy   "
136519|NCT01497834|"     The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032     combination therapy in Japanese subjects.   "
136520|NCT01497821|"     This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in     subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or     who have refractory disease following at least two prior therapies. The purpose of the study     is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective     response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two     Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to     determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose     (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response     rate in subjects treated at the MTD established in Part 1 for either every two week or every     three week dosing.   "
136524|NCT01497756|"     A group of midwives and obstetric nurses have been trained to use circumferential abdominal     pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any     use of a CAPP device will be monitored to identify complications.   "
136525|NCT01497743|"     Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and     anus. Patients with scleroderma often have GIT disorders. GIT disorders can be severely     debilitating and even life-threatening. Some problems associated with GIT disorders may     include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing,     constipation, diarrhea, malabsorption (impaired absorption of nutrients from the GI tract),     diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines),     and the inability to control your bowel movements.      Probiotics are the good bacteria normally found in your digestive tract. Our group is     looking at whether or not taking daily probiotics (lactobacillus) can help alleviate some of     these symptoms in scleroderma patients that have GIT disorders.   "
136526|NCT01497730|"     This post-marketing investigation will evaluate the functional knee performance of Subjects     who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one     of four contemporary knee configurations from different manufacturers will be pooled to     establish a contemporary dataset.      The primary objective of this study is to evaluate the functional performance as measured by     the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score     (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year     post-operation. This will be carried out for all four implant configurations. The final     endpoint is a 2-year evaluation.   "
136527|NCT01497717|"     Hypothesis - Behcet's disease is a multisystemic chronic relapsing inflammatory disease,     classified among the vasculitides. The clinical manifestations include mucocutaneous lesions,     articular, ocular, vascular, gastrointestinal and/or central nervous system involvement.      The aetiology of Behcet's disease is unknown, however. Experimental evidence suggests that     TNF-α may play an important role in the pathogenesis of the disease.      To date, case reports and small open-short term studies report the efficacy of anti-TNFα     therapy (Infliximab and Etanercept), especially regarding ocular and mucocutaneous     involvement in Behcet.      There are no double blind long term studies on larger number of patients regarding the     efficacy of anti-TNFα, especially Humira in healing arthritis +/- other manifestations of the     disease.   "
136528|NCT01497704|"     This protocol will be divided into two parts: Part 1 will evaluate the safety and     pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day     continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an     open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part     1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring     and bimonthly assessments for progression, if the product is well tolerated and the subject     has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.   "
138058|NCT01477697|"     This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in     trauma patients. The main hypothesis is that such supplementation will reduce the presence of     biomarkers of systemic inflammation, as compared to placebo   "
136529|NCT01497691|"     Previous investigations and anecdotal experience have shown safety and utility of Noninvasive     Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the     treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in     children with respiratory insufficiency, emergency department and ICU stays may be shortened,     and the need for more invasive and dangerous airway procedures may be decreased. This would     result in a change in the standard of care for asthma treatment in emergency departments. The     investigators hypothesis is that the use of this new NIPPV, in conjunction with current     standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a     more rapid improvement in patient ventilation, faster resolution of respiratory distress, and     overall improved secondary outcomes.   "
136530|NCT01497678|"     The objective of the study is to assess mechanical strength and function in subjects     undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of     biologic scaffolds for the restoration of both mechanical strength and function in these     subjects. This study will formally evaluate healing and return of function after an     extracellular matrix device implantation in 40 male and female subjects participating at 4-5     military sites who suffer from injury with loss of skeletal muscle tissue. The University of     Pittsburgh under the Department of Plastic and Reconstructive Surgery is the Coordinating     Center for this multi-site study.   "
136531|NCT01497665|"     The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in     patients with brain metastases from non-small cell lung cancer (NSCLC).   "
136532|NCT01497652|"     The present pilot study is designed to assess the extent to which rasagiline may improve     cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary     objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients     who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to     assess changes in the SCOPA-COG, FAB, and UPDRS II & III at the end of week 14.   "
136533|NCT01497639|"     The aim of the study is to compare the efficacy and the safety profile of the newly     introduced interleaving stimulation mode to those of the standard double monopolar     stimulation mode during pallidal deep brain stimulation of primary generalized or segmental     dystonia.   "
136534|NCT01497626|"     This study is for patients with an advanced type of cancer for which no curative treatment     exists.      The purpose of this study is to test the safety and efficacy of the combination of the study     drugs, lapatinib and bortezomib. Lapatinib is a drug that targets two proteins important for     the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins,     lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral     pill given by mouth once every day. Lapatinib is approved by the FDA for patients with breast     cancer.      Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By     inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their     death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is     approved by the FDA for patients with multiple myeloma and mantle cell lymphoma.      This research is being done because it is not known if the combination of lapatinib and     bortezomib will work better than lapatinib or bortezomib alone, although in the lab and in     animal studies the combination of the two drugs was much more effective than either drug     alone.      As part of this study biopsies will be taken of patients' tumors before any treatment, after     starting lapatinib alone, and after receiving both lapatinib and bortezomib. Investigators     want to study what markers inside tumors may relate to how well these two medications work.     These biopsies are required as part of the study.   "
136535|NCT01497613|"     Although technology offers great potential for enhancing the health and well-being of older     adults, robust studies are needed to quantify the value of technology and further the     investigators understanding of barriers to technology access among older adults and of     strategies that are effective in removing these barriers. This cross-site randomized field     trial will evaluate a simple to use Personalized Reminder Information and Social Management     System (PRISM) designed to support social connectivity, memory, skill building and resource     access for older adults. The PRISM system (PRISM C condition) will be compared to an notebook     information control condition (PRISM B condition). The target population is older adults who     live at home alone and are at risk for isolation. The goal of the study is to gather     systematic evidence about the value of technology for older adults and to identify factors     that affect use and usability, acceptance and technology adoption. The investigators will     also gather longitudinal data on the benefits of the system. Participants aged 65 - 85 years     (100 per site) will be randomly assigned following baseline assessment to one of two     conditions: PRISM C condition where participants receive the technology system or the PRISM B     condition only control where participants receive a notebook that includes information     similar to that provided in PRISM C (e.g., resource guide). The categories of information     provided in the notebook is similar to the features provided on the system. Participants will     include males and females who do not have a home computer and who have limited Internet     experience. The intervention period is 12 months. A battery of measures that includes     demographic information, attitudes towards technology (including computer self-efficacy and     computer comfort), technology, computer and Internet experience, functional independence and     well-being, emotional well-being social support/isolation, and quality of life will be     administered at baseline, and 6 and 12 months post randomization. In addition, the     investigators will assess cognitive abilities at baseline and twelve months. The     investigators will also gather data regarding technology use and social interactions via a     brief telephone interview at 18 months post randomization.   "
136536|NCT01497600|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2     diabetes of various race and ethnicity.   "
136537|NCT01497587|"     This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of     insulin detemir in healthy Taiwanese subjects.   "
136538|NCT01497574|"     This trial is conducted in Europe. The aim of this trial is to compare the within-subject     variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in     children and adolescents with type 1 diabetes.   "
136539|NCT01497561|"     This trial is conducted in Europe. The aim of this trial is to investigate the     pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in     subjects with type 2 diabetes.   "
136540|NCT01497548|"     Primary Objective To determine the efficacy of Methylphenidate as add on therapy to     mirtazapine in the treatment of depression in cancer patients under palliative care     Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early     reduction in (Montgomery Asberg Depression Rating Scale) MADRS between baseline and Day 3.      Secondary Objective        1. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in the          treatment of anxiety in cancer patients under palliative care.           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant          early reduction in anxiety score of HADS than Mirtazepine alone treated subjects between          baseline and Day 3.        2. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in          reducing distress in cancer patients under palliative care.           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant          early reduction in distress score of distress thermometer than Mirtazepine alone treated          subjects between baseline and Day 3.        3. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in          improving function in cancer patients under palliative care.           Hypothesis Methyphenidate add on to mirtazapine treated subjects will show increase in          the (Eastern Cooperation Group performance status) ECOG score than Mirtazepine alone          treated subjects between baseline and Day 3        4. To determine the efficacy of Methylphenidate as add on therapy to mirtazapine in          reducing somatic complaints in cancer patients under palliative care.      Hypothesis Methyphenidate add on to mirtazapine treated subjects will show significant early     reduction in the score of Numeric Rating Scale (NRS) for Pain and Visual Analogue Scale (VAS)     for Fatigue than Mirtazapine alone treated subjects between baseline and Day 3.   "
136541|NCT01497535|"     This trial is conducted in Europe. The aim of this trial is to compare the within-subject     variability of insulin detemir to that of another basal insulin analogue, insulin glargine in     healthy volunteers.   "
136544|NCT01497496|"     The main purpose of this study is to see if the combination of ofatumumab with high dose     methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help     people with relapsed or refractory CLL/SLL get rid of their CLL/SLL for a long period of     time. Researchers also want to find out if the combination of ofatumumab with     methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe     and tolerable.   "
136545|NCT01497483|"     This study will address the following question: Does cyclosporine affect the pharmacokinetics     of pravastatin in healthy volunteers? Studies have shown that cyclosporine inhibits the     organic anion transporter required for pravastatin transport into the liver, thus increasing     pravastatin levels in the blood. The investigators hypothesize that this inhibition will vary     among people based on genetic differences. This knowledge is important to help develop safer     and more effective drug therapy with reduced side effects.   "
136546|NCT01497470|"     The primary goal of this study is to determine if custirsen has an effect on the way the body     distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study     will also evaluate if custirsen influences the way the body distributes and gets rid of     carboplatin (another standard administered chemotherapy) and will measure custirsen blood     levels in this cancer population. Finally, the study will evaluate the safety and     tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.   "
136547|NCT01497457|"     MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch     of Douglas. The investigators think that the localization of the rectal tumor in function of     this anatomic mark could be decisive for pre-operative assessment.   "
136548|NCT01497444|"     RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving     sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells.      PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib     tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in     treating patients with advanced kidney cancer or liver cancer that cannot be removed by     surgery.   "
136549|NCT01497431|"     This randomized phase I trial studies the side effects and the best dose of     Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy     participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The     use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium     compounds, may prevent prostate cancer from forming.   "
136550|NCT01497418|"     Collect and evaluate the long term safety data.   "
136566|NCT01497210|"     The primary objective of this study is to evaluate the safety and preliminary performance of     EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.   "
136551|NCT01497405|"     This study compares the effects of standard HIV test, treat and retain (TTR) practices with     TTR plus a woman-focused enhanced strategy--Women's Health CoOp (WHC+) intervention)     targeting hard-to-reach and vulnerable alcohol and other drug (AOD)-using women to determine     if the WHC+ intervention is more efficacious than TTR alone in reducing HIV risk behavior.     Additionally, the study will determine whether HIV positive women in the WHC+ arm are more     likely to follow through with referrals for further medical evaluation and linkages to HIV     treatment and other care than women in the TTR arm.   "
136552|NCT01497392|"     This phase I trial is studying the side effects and best dose of dovitinib lactate when given     together with gemcitabine hydrochloride and capecitabine in treating patients with advanced     or metastatic solid tumors or advanced pancreatic cancer. Dovitinib lactate may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving dovitinib lactate together with combination chemotherapy may kill more tumor     cells   "
136553|NCT01497379|"     Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones     (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.   "
136554|NCT01497366|"     This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in     combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon     (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV)     genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks     after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if     non-inferiority was demonstrated, the study was then allowed to test for superiority.   "
136555|NCT01497353|"     To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after     birth) as an indirect measure of the volume of placental transfusion in a group of healthy     and fullterm newborns, placed at the level of the introitus versus another group placed on     the abdomen of the mother.   "
136556|NCT01497340|"     To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after     birth) as an indirect measure of the volume of placental transfusion in a group of healthy     and fullterm newborns, placed at the level of the introitus versus another group placed on     the abdomen of the mother.   "
136557|NCT01497327|"     This study will be conducted in Hepatitis C positive patients to determine whether the     pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with     normal hepatic function, which may allow inclusion of patients with cirrhosis and varying     degrees of hepatic dysfunction in future clinical studies.   "
136558|NCT01497314|"     The purpose of this study is to show that a low lactose milk-based infant formula supports     normal growth in healthy term infants.   "
136586|NCT01496937|"     The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974     present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy     subjects.      Furthermore, during the course of the study, safety and tolerability as well as the effects     of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be     characterized compared to placebo.   "
136559|NCT01497301|"     Much evidence exists that new, more effective methods of delivering care to diabetics are     necessary. In our current system of delivering care, diabetes care is often done in the     context of multiple other issues addressed during a regular office visit. Providers often     lack the time to properly educate patients on diabetes self management topics. This project     hopes to show that group visits can improve clinical outcomes, patient satisfaction, provider     satisfaction, and patient's self management knowledge, while decreasing cost. This group     visit method can make care more patient-centered and team based which is in alignment with     our organization's goal of becoming a true patient centered medical home. If successful, this     could expand to our other family medicine clinic sites and provide a valuable learning     opportunity for the family medicine residents at OHSU.      The investigators will first identify newly diagnosed diabetics (diagnosed within the last 12     months) at the South Waterfront and Gabriel Park family medicine clinics using EPIC. The     investigators will invite those diabetics identified from the South Waterfront clinic to     participate in 6 group visits that will follow a curriculum that the investigators created     based on the National Standards for Diabetes Self Management Education and the ACP Diabetes     Care Guide. This curriculum will address basic pathophysiology of diabetes, the ABCs to     Better Diabetic Care as defined by the ACP Diabetes Care Guide, setting goals, nutrition,     exercise, diabetic medications, and complications of diabetes. This intervention group will     be compared to a control cohort identified at the Gabriel Park clinic that will continue to     receive standard diabetes care from their primary physician. The investigators will look at     and compare clinical outcomes (Hemoglobin A1C, blood pressure (BP), and LDL cholesterol     levels), adherence to recommended preventive measures for diabetics (foot exams, eye exams,     yearly microalbumin, and immunizations), patient and provider satisfaction, as well as cost.     Cost data will be collected using EPIC to look at the costs involved in group visits compared     to the cost of delivering diabetic care through the standard individual medical appointment.     The investigators may also use EPIC to look at utilization of specialty services, emergency     room visits, and inpatient admissions and compared utilization across groups.   "
136560|NCT01497288|"     The overall clinical trial objective is to gain information about the Pharmacokinetics (PK)     of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male     and female subjects are planned to be randomized in the trial. Subjects will be randomized to     one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS,     400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will     be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic     samplings will be conducted.   "
136561|NCT01497275|"     The purpose of this study is to evaluate the effects (good and bad) of the combination of     ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory     mantle cell lymphoma.      Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with     another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells     and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in this     study, along with Velcade.   "
136562|NCT01497262|"     This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg     in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data     in Multiple Sclerosis (MS) patient population that closely resembles the clinical population     seen in routine medical care.   "
136563|NCT01497249|"     The objective of this study is to provide evidence for its fermentability of a dietary fiber     and to collect information regarding potential health opportunities for glucose control as     well as tolerability when being consumed over 7 days.   "
136564|NCT01497236|"     The purpose of this study is to determine whether 14 days nutritional supplementation with     Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection     will prevent malnutrition and reduce the frequency of morbidity.   "
136565|NCT01497223|"     The primary objective of the study is to evaluate the rate of therapeutic cure of the     combination treatment of MGCD290 and fluconazole as compared to that of fluconazole alone at     Test of Cure Visit for patients with moderate to severe vulvovaginal candidiasis.   "
136567|NCT01497197|"     This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label,     comparative trial which primary objective is to generate data on the ovarian stimulation     profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced     reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).   "
136568|NCT01497184|"     The goal of this clinical research study is to learn if researchers can successfully and     safely give HSCT patients an infusion of white blood cells (called T-cells) that have been     genetically changed. The process of changing the DNA (the genetic material in cells) of these     T-cells is called gene transfer. Researchers want to learn if these genetically-changed     T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or     leukemia, after they have received standard allogeneic HSCT. Researchers want to find out the     highest dose of these special T-cells that can be given safely to leukemia and lymphoma     patients. Researchers also want to learn how long the changed T-cells stay in your body, and     if adding them to standard transplant can improve how you respond to treatment.   "
136569|NCT01497171|"     This study is designed to compare the safety and efficacy of a commercially available mesh     kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair     surgery.   "
136570|NCT01497158|"     This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a     novel approach of adoption of home smoking restrictions. This will be done by providing the     cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The     intent is to identify an intervention strategy(ies) to reduce ETS exposure.   "
136571|NCT01497145|"     This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to     Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects     with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.   "
136572|NCT01497132|"     The purpose of this study is to evaluate if treatment with vitamin D increase beta cell     function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes     mellitus type 2.   "
136573|NCT01497119|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of     JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.   "
136574|NCT01497106|"     This study is being done to understand the effects of calorie restriction and weight loss on     muscle protein metabolism in adult men and women.   "
136575|NCT01497093|"     The purpose of this study is to determine the maximum tolerated dose (MTD) of pomalidomide in     combination with bortezomib and low-dose dexamethasone in subjects with relapsed or     refractory multiple myeloma   "
136587|NCT01496924|"     There is an association between increased risk of oropharyngeal dysphagia and artificial     ventilation through endotracheal tube, followed by tracheostomy. The aim of the present study     is to analyze the outcomes of an early swallowing rehabilitation program of dysphagic     tracheostomized patients under mechanical ventilation at the intensive care unit.   "
136576|NCT01497080|"     The Problem Distal radius fractures (DRF) are common and result in a variable amount of     disability. The investigators have completed considerable work in developing tools that     measure impairment and disability after DRF . The investigators initial studies indicate that     the associated disablement process is multifactorial and variable with only 25% of the     resultant disability predicted by baseline patient and injury characteristics. The     investigators see DRF as a signal event where some people are at-risk of transitioning from     an active lifestyle to inactivity and subsequent health risks. The investigators recent data     confirms variable participation following a DRF. The traditional focus in     orthopedic/rehabilitative approaches to DRF fracture management has been localized to the     wrist, largely ignoring this potential transition and its health impacts. The investigators     will initiate a line of investigation that will profile the at-risk older adult who presents     with a DRF with the ultimate goal of accurate identification and prevention of adverse     activity transitions (active to inactive). In this study the investigators will identify the     extent of the problem by quantifying changes in activity/participation and its short-term     health impacts. The investigators will also identify the risk factors present at time of     injury that predict a loss of mobility/activity/participation. This work has the potential to     identify tools and/or clinical prediction rules that identify at-risk individuals at a     critical time where early intervention might most easily prevent adverse outcomes associated     with inactivity.   "
136577|NCT01497054|"     The purpose of this study is to determine if B type natriuretic peptide (BNP) levels can be     used to predict a hemodynamically significant patent ductus arteriosus (PDA). This peptide is     produced by the ventricles in the heart when they are under stress, such as when a ductus     remains open. If we can use a simple and inexpensive blood test to determine whether a PDA     needs to be treated, we can potentially treat infants sooner than if they needed to wait for     the availability of a cardiologist to perform an echocardiogram. This might decrease some of     the deleterious effects of PDAs on the preterm infant such as bronchopulmonary dysplasia,     necrotizing enterocolitis, renal hypoperfusion, and pulmonary hemorrhage. In a situation     where follow up echocardiogram after a course of medical therapy shows persistent PDA, this     test may help to decide whether this baby needs further treatment, either medical or     surgical.   "
136578|NCT01497041|"     1. Goals           The primary goal of this phase II trial is to:           evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in          patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as          second-line treatment           Secondary goals are to:           evaluate the treatment-related toxicities of this combination, investigate          progression-free survival (PFS) and overall survival (OS) in this population        2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase          II trial according to the two stage testing design by Simon two-stage testing procedure   "
136579|NCT01497028|"     This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable     Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in     bariatric surgical outcomes        -  Weight Loss        -  Co-morbid disease resolution   "
136594|NCT01496833|"     The purpose of this study is to investigate the short to mid term efficacy and safety of a     newly-developed branched stent graft in patients who had complex aortic lesions, such as     ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde     Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.   "
136625|NCT01496430|"     The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as     well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in     stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was     inadequate on metformin alone.   "
136580|NCT01497015|"     This is a randomized controlled trial to evaluate the ACTIVE memory training intervention and     ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims     and hypotheses are:      Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among     Breast Cancer Survivors (BCS).      Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as     more acceptable and useful than BCS assigned to the attention control condition.      Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to     the attention control and no-contact control conditions.      Hypothesis 2: Memory training will result in greater memory enhancement immediately post and     2-months post-intervention relative to attention control or no-contact control conditions.   "
136581|NCT01497002|"     Improvement of the treatment-results in elderly patients with acute myeloid leukemia through     intensification of consolidation chemotherapy and/or allografting as consolidative     immunotherapy   "
136582|NCT01496989|"     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of     multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human     IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in     low-risk for HIV-uninfected healthy adults.   "
136583|NCT01496976|"     The main purpose of this study is to see if ofatumumab with methylprednisolone followed by     additional treatment with ofatumumab and lenalidomide can help people with Chronic     Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also     want to find out if the combination of ofatumumab with methylprednisolone followed by     additional treatment with ofatumumab and lenalidomide is safe and tolerable.   "
136584|NCT01496963|"     This is a multicenter observational case-control analysis lasting 12 months aimed at     determining the prevalence of pulmonary hypertension (PAH) in patients with Thalassemia Major     and Intermedia. The patients will be followed, treated and examined according to the best     standard clinical practice dictated by the Italian Society for the study of     Hemoglobinopathies (SITE), Thalassemia International Federation (TIF)and the Task Force for     Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC);     European Respiratory Society (ERS); International Society of Heart and Lung Transplantation     (ISHLT) guidelines.   "
136585|NCT01496950|"     The purpose of this study is to determine whether active repetitive transcranial magnetic     stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive     treatment of chronic migraine, compared to placebo repetitive transcranial magnetic     stimulation.   "
136588|NCT01496911|"     Antihistamines are commonly used and currently levocetirizine is most frequently prescribed     in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems,     especially to open tubal passage. However, the effects of these drugs on cognitive     performance have not been investigated during diving.The objective of this study is to     investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and     psychomotor functioning during controlled simulated diving in a hyperbaric chamber in     professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that     hydroxyzine will produce significant impairment, and that the magnitude of impairment is     related to hyperbaric pressure.   "
136589|NCT01496898|"     The goal of this study is to examine changes in the bacterial ecology and inflammatory     markers of the female genital tract with levonorgestrel intrauterine device placement.      The specific research objectives of this project include:        1. Characterization of vaginal, cervical and uterine bacterial species and communities          prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples          will be collected up to 1 week before and 2 months after IUD insertion.        2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to          and after LNG IUD placement using human RNA microarray analysis. Samples will be          analyzed from up to one day before and three weeks after IUD insertion.        3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.   "
136590|NCT01496885|"     The purpose of this study is to evaluate the utility of the S-STREAM as an instrument to     assess motor function in subjects who have experienced a nonhemorrhagic ischemic stroke.   "
136591|NCT01496872|"     Two prominent osteopathic physician researchers have studied cranial somatic dysfunction in     newborns. Dr Viola Frymann published a paper in 1966 on the presence of somatic dysfunction     involving 1250 infants. Dr. Jane Carreiro evaluated 1600 newborns in 1993 for cranial somatic     dysfunction. This observational study is intended to continue their work in exploring the     presence of cranial somatic dysfunction in newborns. The hypothesis is that there is an     increased incidence of somatic dysfunction in newborns birthed by primigravid women and in     newborns who experienced a longer second stage of labor.   "
136592|NCT01496859|"     The Baska mask is a new supraglottic airway device . The investigators would like to assess     its performance in setting in which the current standard - LMA device - is being used.   "
136593|NCT01496846|"     The purpose of this study is to study the ability of a frequently used dental anesthetic     (articaine) to achieve complete numbness of a diseased tooth with the most commonly used     injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique     fails, a commonly used supplemental technique with one of two possible dental anesthetics     (lidocaine or articaine) will be given to evaluate the success/failure of complete numbness     between the two anesthetics.      The investigators hypothesize that supplemental infiltration anesthesia with articaine will     give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular     molars with irreversible pulpits.      This study consisted of two periods of patient enrollment, treatment and data collection:     Part I: 101 subjects; Part II: 100 subjects.   "
136595|NCT01496820|"     The effects of chitosan on blood glucose levels have been contradicting. Hypoglycemic effects     of high molecular weight chitosan are related to diabetic models with hypoinsulinemia but     have shown little effect on the blood glucose levels in hyperinsulinemia related diabetic     models. Based on previous reports, high molecular weight chitosan either directly or     indirectly related to insulin secretion in pancreas but has little effect on insulin     resistance. In the present study, the effect of GO2KA1 (low molecular weight chitosan     oligosaccharide) on blood glucose levels in Korean pre-diabetic adults, will be evaluated.     The changes in postprandial blood glucose levels will be investigated in subjects with     impaired fasting glucose or glucose tolerance.   "
136596|NCT01496807|"     The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when     it is given to people who are also receiving a drug called Sylatron. Investigators also wish     to find out whether the addition of Yervoy increases the chance that Sylatron will cause a     rise in the level of antibodies in the patient's blood that recognize their own tissues,     known as autoimmune antibodies. Investigators also want to find out how likely it is that     their tumor will shrink.   "
136597|NCT01496794|"     The intent of this surveillance study will be to obtain written permission from patients with     bacterial endophthalmitis in order to compare sterilization rates of their cultured bacterial     isolates to standard therapy (vancomycin and ceftazidime) versus combination therapy with     vancomycin, ceftazidime, and moxifloxacin.      Research hypothesis:        1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with          combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to standard          therapy with vancomycin and ceftazidime.        2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing          rates of multi-antibiotic resistance.   "
136598|NCT01496781|"     Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment     techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common     complication following EMR. Several endoscopic hemostasis methods are currently in use     including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new     hemostasis material was previously used for surgical hemostasis, but the therapeutic effect     and safety in endoscopic application remains unknown. This randomized controlled study has     been designed to compare PAPH with metallic hemoclip in their hemostatic effect of     intra-procedure bleeding control and rebleeding prevention during and after EMR.   "
136599|NCT01496768|"     This study aims to evaluate the effects of chronic leucine supplemetion on glucose     homeostasis, body compositin, muscle mass and strength of healthy and young subjects   "
136600|NCT01496755|"     This randomized, double-blind, placebo-controlled study will evaluate the safety and     pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to     receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on     study treatment is up to 57 days with a 12-week follow-up.   "
136633|NCT01496326|"     This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment     of ibuprofen compared to the use of a placebo topical treatment.      A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days     Dosing twice daily (b.i.d.)   "
136601|NCT01496742|"     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the     efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone     chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV     non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive     4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum     (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day     cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum     (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day     cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy     with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or     pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is     until disease progression or unacceptable toxicity occurs.   "
136602|NCT01496729|"     Postoperative pain is a major problem in patients who either donate a kidney or undergo     kidney transplantation. This pain is commonly treated with opioids, which can cause several     side effects, ranging from pruritus, impaired vigilance, and most concerning to severe     respiratory depression. This can be aggravated in the recipient by accumulation of opioid     metabolites secondary to renal impairment and secretion.      Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP)     block after surgery in the lower abdomen. In the proposed study, we plan to compare the     impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a     ultrasound guided sham block with normal saline (placebo) on postoperative pain scores,     postoperative opioid consumption, as well as patient's satisfaction.      The investigators hypothesize, that patients who receive a TAP block will have lower     postoperative pain scores, lower postoperative opioid consumption as well as higher     satisfaction scores.   "
136603|NCT01496716|"     The purpose of this study is to investigate whether there is a correlation between hip     arthroplasty patients' preoperative weight and the patients quality of life and the clinical     effect one year postoperatively.   "
136604|NCT01496703|"     Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with     improved graft survival in renal transplant recipients. However, MMF-related side effects     often necessitate dose reduction which may expose transplant recipients to a higher risk of     acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose     reduction during the first year after kidney transplantation and its impact on acute     rejection, overall and death-censored graft loss. Methods: Retrospective electronic file     based analysis of all patients who underwent a single kidney transplantation in our center     between 1996 and 2007 and were treated with MMF as part of their initial maintenance     immunosuppressive protocol (n=749).   "
136605|NCT01496690|"     The PACS study aims to investigate the efficacy and tolerability of pregabalin for     schizophrenic patients that suffer from comorbid anxiety.      The study design is an 8 week flexible dosage, randomized placebo controlled.      The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients     are recruited from outpatient clinics from entire Denmark.   "
136606|NCT01496677|"     To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger     control subjects   "
136607|NCT01496664|"     The purpose of the registry is to assess results of combined operative and catheter based     (hybrid procedure) treatment of patients with significant coronary artery disease using     essential clinical and angiographic parameters.      Based on existing literature we expect the results of coronary artery bypass grafting of the     anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary     artery graft, to be superior to stent treatment of the same artery.      At the same time a catheter based intervention using balloon, bare metal stents (BMS) or drug     eluting stents (DES) seems to be a better treatment that a saphenous vein graft for other     coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left circumflex     coronary artery (CX).      Therefore, we expect a combination of the mentioned surgical and catheter based techniques to     be a better treatment than bypass operation or catheter based intervention alone.   "
136608|NCT01496651|"     Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty     in the Treatment of Unprotected Left Main Stenosis.      In a clinical, randomized, 5-year follow-up study to compare essential clinical outcome     parameters in patients with unprotected left main (LMCA) disease, treated with coronary     artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) using drug     eluting stents (DES).      DES-PCI of unprotected LMCA disease is non-inferior to CABG concerning the 2-year rate of     death, myocardial infarction, stroke or new revascularization and concerning the 5-year rate     of death.   "
136609|NCT01496638|"     How should coronary artery stenoses with significant side branch be stented?      A strategy of stenting both main vessel and side branch compared to a strategy of stenting     the main vessel and only stenting the side branch if necessary.      The 2-stent strategy is superior to the 1-stent strategy regarding occurrence of cardiac     death, non-procedure related myocardial infarction and re-revascularization with percutaneous     coronary intervention (PCI) or coronary artery bypass grafting (CABG).   "
136616|NCT01496547|"     Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell     transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8%     while 90% patients eventually relapsed with marrow ablative conditioning mostly standard     iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the     conventional transplantation approach may not be able to overcome the refractory disease. A     new strategy to combined a low dose regimen following intensive chemotherapy for tumor     reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this     study, we focus on a new treatment strategy for particular refractory AML patients.   "
136617|NCT01496534|"     This is a phase Ib dose escalation study of dovitinib given in combination with either     gemcitabine plus cisplatin or carboplatin in patients with advanced solid tumors. Patients     with advanced solid tumors, for whom treatment with gemcitabine plus cisplatin or carboplatin     would otherwise be warranted, will be enrolled. The dose of dovitinib will be escalated in     successive cohorts using standard 3+3 dose escalation rules. Patients will continue     treatment, in the absence of prohibitive toxicity, until disease progression. The study will     define the recommended phase II dose of these combination regimens.   "
136610|NCT01496625|"     Background:      - To understand diseases of the retina and the eye, information is needed about people with     and without such diseases. Researchers want to study these people and follow them over time.     They also want to study body tissues and blood to understand the nature of eye disease.     Studying genes, cells, and tissues may help them understand why some people get eye problems     and others do not, or why some people respond to treatment while others do not. Researchers     want to collect physical samples and personal data to develop a National Eye Institute     database.      Objectives:      - To collect health information and blood and tissue samples from people with and without eye     diseases, to be used in research studies.      Eligibility:        -  Individuals of any age with different types of eye disease.        -  Healthy volunteers with no history of eye disease.      Design:        -  Participants may be recruited from National Eye Institute studies or may be referred          from other sources.        -  Participants will be screened with a physical exam and medical history. They will also          have a full eye exam. Questions will be asked about family medical history, especially          about eye disease.        -  Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and          urine, may be collected as needed. Adult participants may also provide a skin sample.        -  Tissue or fluid from eye collected as part of eye care or treatment may also be added to          the database.        -  No treatment will be provided as part of this study.   "
136611|NCT01496612|"     Background:      - Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies     suggest that buspirone might act on parts of the brain that can increase certain levels of     brain activity. Increasing this brain activity may help decrease epileptic seizures that come     from certain parts of the brain. Researchers want to see if buspirone can reduce seizure     frequency in people with seizures who are already taking antiseizure medication.      Objectives:      - To test whether buspirone can reduce the frequency of seizures in people whose seizures     seem to start from one part of the brain.      Eligibility:        -  Individuals between 18 and 65 years of age who have seizures coming from one or more          places in the brain.        -  Participants must have tried at least two different antiseizure medications. They must          also have had at least three seizures during a 1-month observation period while on          current medicines.      Design:        -  Participants will have a screening visit with a physical exam and medical history.          Participants will complete mood and memory testing scales. Blood, urine, and saliva          samples will be collected.        -  Participants will have a magnetic resonance imaging scan to evaluate brain structures          that relate to epilepsy. They will also have a positron emission tomography scan to look          at parts of the brain that are affected by buspirone.        -  Participants will start taking a study drug (either buspirone or placebo) twice daily.          They will keep a calendar of seizures and record any side effects. Treatment will be          monitored with clinic visits and blood samples.        -  After 12 weeks on the study drug, participants will gradually stop taking either the          placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks.        -  After 2 weeks, participants will start taking a study drug that is the opposite of the          one they had before. They will keep a calendar of seizures and record any side effects.          Treatment will be monitored with clinic visits and blood samples.        -  After 12 weeks on the study drug, participants will gradually stop taking either the          placebo or buspirone.        -  Participants will have a final followup visit with additional blood tests, mood and          memory testing scales and imaging studies.   "
136612|NCT01496599|"     Background:      - Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the     loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not     fully understand why the brain cells that produce dopamine stop working or die in people with     PD. This study will use different ways of imaging the brain and brain chemicals to look at     PD. It will compare brain imaging in people who definitely have PD to people who might have     PD and to people without signs of PD. It will provide more information how the brain in     people with PD changes over time.      Objectives:      - To understand the changes that occur in the brains of people with Parkinson s disease.      Eligibility:        -  Individuals at least 18 years of age who have definite or possible Parkinson s disease.        -  Healthy volunteers at least 18 years of age.      Design:        -  Participants will have a screening visit with a physical exam and medical history. Blood          and urine samples will be collected.        -  Participants will visit the National Institutes of Health Clinical Center once a year          for 9 years. There will be 10 total visits. Most visits will last 5 to 6 hours a day for          2 to 3 days. Some or all of the following tests will be performed at each visit:        -  Transcranial sonography, which uses sound waves to take pictures of the brain.        -  Magnetic resonance imaging to take pictures of the brain. Some of these tests will be          done at rest. Others will require participants to perform an activity during the scan.        -  Dopamine imaging studies to show how the brain uses the chemical dopamine.        -  Magnetoencephaolgraphy to show brain activity.        -  Electromyography to show muscle activity.        -  Medication withdrawal for 12 hours overnight for people taking PD medications. This may          be done before some scans. Participants who feel unwell when they stop taking          medications will be allowed to start taking them again.        -  Participants will continue with the followup visits until the end of the study.   "
136621|NCT01496482|"     Purpose:      To establish whether there is a correlation between dry eye symptoms, age and gender, a     difference in symptom intensity in different times of the day, which test (Schirmer or TBUT)     better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy     to use hygrometer in everyday clinical setting, and finally whether there is statistically     significant correlation between applied tests (TBUT, Schirmer and evaporimetry).      Methods:      Subjects: 45 in group without dry eye related symptoms, and 45 in group with symptoms.      Examination included structured case history (questionnaire), slit lamp examination with     fluorescein staining, periocular evaporimetry, TBUT test and Schirmer test.   "
136622|NCT01496469|"     The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared     to placebo on lowering ambulatory 24-hour mean blood pressure of participants with     hypertension and hyperuricemia (not associated with gout).   "
136613|NCT01496586|"     Background:      - Many service members have reported feeling tired, a loss of motivation, mood changes, and     problems working with others after they have a concussion during deployment. These problems     may lead to problems with their job and relationships. This study hopes to figure out what     parts of the brain may be affected in people with these problems after a concussion.      Objectives:      - To learn more about the problems that may occur after service members have a concussion     during deployment and return home.      Eligibility:        -  Service members or veterans between 18 and 40 years of age who have had a mild traumatic          brain injury (concussion) in the past 6 months.        -  Companions (at least 18 years of age) of the service members will also be included in          this study. Companions will have interacted with the service member at least 1 hour a          week since deployment.      Design:        -  Service members will have 1 week of tests at the National Institutes of Health Clinical          Center. Companions will have 2 days of tests at the Center.        -  Each day, service members will have 4 or 8 hours of tests. Tests will include a medical          history and physical exam, neuropsychological tests and imaging studies. The tests will          ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging          studies will measure brain function at rest and during activity.        -  Companions will have a medical history and physical exam. They will also complete          several questionnaires about themselves as well as the service member/veteran. The tests          will ask about fatigue, stress, mood, pain, daily activities, and family support.   "
136614|NCT01496573|"     This research trial studies biomarkers in tumor tissue samples from younger patients with     rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer   "
136615|NCT01496560|"     The aim of the study is to determine what precolonoscopic measures can be correlated to pain     during colonoscopy   "
136618|NCT01496521|"     Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an     antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and     efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this     double-blind, randomized controlled clinical trial. Research project is planned to recruit     10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China,     which has been known as a high incidence region of ESCC. All the participants receive     endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained     lesions (USLs). The location and size of each USL will be recorded followed by collecting     biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d     of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months.     Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six     months and the second at 3 or 5 years later). The primary outcome measure was occurrence of     high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the     participants and adverse events.   "
136619|NCT01496508|"     Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks     gestation; surfactant and mechanical ventilation have been the standard treatment. However,     despite advances in neonatal respiratory care, a considerable number of preterm infants     develop chronic lung disease, termed bronchopulmonary dysplasia (BPD), which is associated     with neonatal death, prolonged neonatal intensive care stay, and impaired neurodevelopment.     High-frequency oscillatory ventilation (HFOV) was developed as a new ventilation technique in     the late 1970s. It was expected to result in less BPD and death as a primary model of     ventilation compared to conventional ventilation (CV) in the treatment of RDS. However, there     is disagreement concerning the advantage of HFOV over CV in the treatment of RDS in preterm     infants regarding the prevention of death, BPD, intraventricular hemorrhage, and     periventricular leucomalacia in the short term. The purpose of this study was to compare the     efficacy and safety of HFOV and CV in preterm infants with severe RDS.   "
136620|NCT01496495|"     This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic     syndromes (MDS) will receive investigational study drug ARRY-614.      This study has 2 parts. In the first part, patients will receive increasing doses of study     drug in order to achieve the highest dose of the study drug possible that will not cause     unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1     (Completed).      In the second part of the study, patients will receive the best dose of study drug determined     from the first part of the study and will be followed to see what side effects and     effectiveness the study drug has, if any, in treating the cancer. Approximately 30 patients     from the US will be enrolled in Part 2 (Completed).   "
136623|NCT01496456|"     This study is investigating the efficacy of caries lesion infiltration therapy as compared to     the current preventative approach for early caries lesions.   "
136624|NCT01496443|"     The purpose of this study is to determine the pharmacokinetics and safety of TAK-875, once     daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus     (T2DM).   "
136626|NCT01496417|"     This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney     transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland     Aggregate Pathology Index) score is a preimplantation donor scoring system which has five     histopathological parameters that impact long-term kidney outcomes. Many kidney transplant     recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations.     Kidney function may be affected by anti-rejection medications known as calcineurin inhibitors     (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney or episodes     of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using belatacept     therapy (BMS) instead, may be associated with improved kidney transplant outcomes.   "
136627|NCT01496404|"     The aim of this research project is to compare electrocautery to scalpel for laparotomy skin     incisions, with the following objectives:        1. To investigate whether electrocautery produces a cosmetically inferior surgical scar.        2. To compare the rates of wound infection with each technique.        3. To determine if electrocautery results in less postoperative pain. Our null hypothesis          is that electrocautery is equivalent to scalpel for creating skin incisions; with          respect to wound cosmesis, wound infection rate, and post-operative pain.   "
136628|NCT01496391|"     Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a     kidney imaging agent or tracer that lights-up inside your body when scanned, but over the     years its use has declined. The most commonly used tracer is Technetium-99m labelled     Mercaptoacetyltriglycine ([Tc-99m]-Mertiatide or [Tc-99m]-MAG3). However, long-term shortages     may threaten the supply of the radioactive substance Tc-99m in Canada and the world. As a     result of such shortages, there is a need to identify other types of tracers that can be used     for imaging. [I-123]-OIH may be an alternative.      The purpose of this study is to examine the diagnostic performance characteristics of     [I-123]-OIH in comparison to [Tc-99m]-MAG3.   "
136629|NCT01496378|"     The purpose of this study is to evaluate the feasibility and efficacy of problem-solving     skills training (PSST) to reduce distress and increase coping abilities among parents of     youth with chronic pain. We hypothesize that parents will complete the PSST intervention and     will find it to be an acceptable and satisfactory treatment. We also hypothesize that parents     who receive PSST will have less distress and better coping skills than parents who receive     standard care, and that children of parents who receive PSST will have better physical and     emotional functioning than children of parents who receive standard care.   "
136630|NCT01496365|"     The purpose of this study is to evaluate the safety, tolerability and effectiveness of     DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with     DPN.   "
136631|NCT01496352|"     This is a randomized, double-blind, placebo controlled, safety, tolerability, and     pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal     surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.   "
136632|NCT01496339|"     The purpose of this study is to investigate whether the treatment of human menstrual     blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and     effective.   "
138404|NCT01473160|"     The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked     daily disposable contact lens as compared to a commercially available daily disposable     contact lens.   "
136634|NCT01496313|"     The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day     or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It     will also help the investigators understand the side effects of different doses in these     patients.   "
136635|NCT01496300|"     This study was initiated to investigate the impact of the computer based image free     navigation on the precision of the cup implantation. The implantation of the acetabular     component (cup) is known to be a critical step in hip endoprosthetics. The cup position     influences significantly the function, the absence of pain and the longevity of the     artificial hip joint. The image free navigation system OrthoPilot is used to control the     positioning of the cup during surgery.   "
136636|NCT01496287|"     The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS     for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.   "
136637|NCT01496274|"     This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control     and prevention of bleeding episodes in subjects who have previously received factor     replacement therapy for hemophilia B.   "
136638|NCT01496261|"     The purpose of this study is to compare pharmacokinetics between fixed-dose combination and     separate combination of clopidogrel 75mg/aspirin 100mg.   "
136639|NCT01496248|"     The purpose of this study is to determine whether Korean Red Ginseng are effective in the     treatment of the residual symptoms of depression as an adjuvant treatment.   "
136640|NCT01496235|"     Arterial hypertension is one of the most preventable risk factors for stroke, cardiovascular     and renal disease. Cocoa is rich in a subclass of flavonoid called flavanol this increase     nitric oxide production and is involved in controlling blood pressure.   "
136641|NCT01496222|"     This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is     used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients,     scheduled for general, vascular or urological surgery under general and/or regional     anesthesia.   "
136642|NCT01496209|"     A double blinded and placebo-controlled, dose escalation, single-center safety and     preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in     subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document     myocardial regeneration in patients with chronic scar.   "
136654|NCT01496040|"     The purpose of the study is to assess the safety and efficacy of the active substance     rAAV-2/4.hRPE65 in patients with Leber Congenital Amaurosis or Congenital severe early-onset     retinal degeneration associated with RPE65 mutation.   "
136655|NCT01496027|"     The aim of the study is to compare the values of cerebral tissue oxygenation measured     simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.   "
136656|NCT01496014|"     The purpose of this study is to characterize the bacteria in the wound bioburden at the     time of definitive wound coverage/closure of severe tibia fractures in both the military and     civilian populations.   "
136643|NCT01496196|"     Hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that     varies from blood-streaking of sputum to coughing up large amounts of pure blood.      Massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period.      The most common site of bleeding is the tracheobronchial tree, which can be affected by     inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic     carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). The bronchial     arteries, which originate either from aorta or from intercostal arteries, and are part of the     high-pressure systemic circulation, are the source of bleeding in bronchitis or     bronchiectasis or endo bronchial tumors.   "
136644|NCT01496183|"     The purpose of this study is to look at how a two-week use of a medication called Olanzapine     might change appetite, physical activity, resting metabolic rate, body composition, and     weight in healthy men.   "
136645|NCT01496170|"     This study will assess the safety and pharmacodynamics of three different doses of MK-8931, a     ß-secretase inhibitor, in participants with mild to moderate Alzheimer's Disease (AD).   "
136646|NCT01496157|"     The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor     of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC), as a PET imaging biomarker     of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well     characterized histological marker of prostate cancer tumor aggressiveness but a quantitative     non-invasive method for PSMA detection and monitoring is not currently available. Development     of such an imaging biomarker would be useful to differentiate indolent from aggressive     prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies.     The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake     in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators     propose to study patients initially diagnosed with biopsy-positive prostate cancer to     determine if DCFBC uptake and location by PET imaging will be positively correlated with     prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of     suspected metastatic disease will be compared to conventional imaging modalities (CT, bone     scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be     compared with expression levels of PSMA and other prostate cancer relevant markers (PSA,     Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with     clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived     prediction of pathologic stage).   "
136674|NCT01495780|"     Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor     visits, using things like at-home breathing tests, electronic diaries to answer     questionnaires, and other monitoring devices. The hypothesis of this study is that the health     and quality of life of people with COPD who do RHM for one year will be better than people     with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with     chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema,     and are current or former smokers will be invited to participate. This study is paid for by     eResearch Technology (eRT).      Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will     participate in RHM. RHM will involve daily monitoring at home using a few electronic devices:     blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring.     Visits will include physical exam and medical history, ECG, questionnaires, breathing tests,     and exercise tests.   "
136647|NCT01496144|"     Background: Models have tried to explain the driving mechanisms behind chronic non specific     low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered     responses at spinal and/or supraspinal level may affect the perception of pain and degree of     disability of CNSLBP patients. Recent clinical recommendations still propose active exercises     (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related     manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic     effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The     aim of this study was first, to assess whether MT has an instant analgesic effect, and     second, to compare the long-lasting effect on functional disability of MT followed by AE to     sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities,     randomly distributed into 2 treatment groups, received either spinal     manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned     ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were     delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain     intensity (Visual Analogue Scale) before and immediately after the first intervention of each     therapeutic session. Pain intensity, disability (Oswestry Disability Index) and     fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before     treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.   "
136648|NCT01496131|"     This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate     cancer.   "
136649|NCT01496118|"     Relapsed/refractory Multiple Myeloma (MM) is an incurable disorder with a poor prognosis.     Carfilzomib is a novel proteasome inhibitor with activity in this setting. Panobinostat is a     pan-deacetylase inhibitor which has shown synergistic cytotoxicity in vitro and in vivo with     proteasome inhibitors. The combination should enhance the activity of both agents against     myeloma cells. In Phase I, the optimal doses of the combination of carfilzomib and     panobinostat will be determined. Assuming this combination is feasible, the Phase II portion     will proceed using the doses determined in Phase I.   "
136650|NCT01496105|"     The purpose of this study is to determine whether the topical use of lidocaine spray 10% on     the cervix is an effective way to reduce pain during IUCD insertion.   "
136651|NCT01496092|"     The overarching aim of this proposal is to examine the effects of usual protein diet     supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis     (PD). The investigators will achieve this goal through a randomized controlled trial of     administration of usual protein diet plus KA versus usual protein diet alone in patients on     peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study     will provide potential avenues for improvement of metabolic profile of patients on PD and     possibly improve long-term outcomes such as cardiovascular disease risk and death.   "
136652|NCT01496079|"     Study objectives are to compare        -  influenza antibody levels in infant sera and maternal colostrum or breast milk at          delivery, 2, and 6 months women who receive influenza immunization in early pregnancy,          late pregnancy, or no influenza immunization during pregnancy and their infants      Study hypotheses are that infants born to pregnant women who receive influenza immunization     in late pregnancy will have        -  higher levels and a longer serum influenza antibody duration in sera (hemagglutination          inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by          enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early          pregnancy or not immunized   "
136653|NCT01496053|"     Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in     patients with ulcerative colitis (UC) and Crohn`s disease (CD), experience clinical,     biochemical and genetical improvement in their disease.      A prospective randomised study comparing the mushroom extract with placebo.   "
136657|NCT01496001|"     The initial aesthetic and functional conditions are recorded with the help of the Breast     Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the     Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer     software, allowing for comparison. Determination of the initial quality of life is measured     with the European Organisation of Research and Treatment of Cancer - Quality of Life     Questionnaire number C30-BR23 (EORTC QoL C30-BR23).      Patients then undergo surgical treatment according to institutional protocols. Following     conventional marking of the orientation of the specimen, it is measured by an analytical     scale.      Histological examination of the specimen will record the largest diameters, and parameters of     the lymph nodes, according to the institutional protocol.      On the 4th week following surgery, assuming that wound healing is completed, patients' data     are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are gained     after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic resonance     imaging is performed to assess the volume of the contralateral breast.      Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each     quadrant, threshold value in the quadrants, above of which it is not advisable to perform     conventional breast conserving surgery due to poor outcomes.   "
136658|NCT01495988|"     This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1)     standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor     cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood     vessel formation and can stimulate the immune system. Previous clinical studies in melanoma     have shown that bevacizumab may improve clinical benefit (progression free survival) if     combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a     role in resistance to BRAF inhibitors. This randomized study will ask whether the addition of     bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates and     clinical benefit. Patients may have received no therapy for advanced disease or up to 2 prior     therapies, excluding BRAF and MEK inhibitors.   "
136659|NCT01495975|"     The goal of this research is to evaluate the impact and feasibility of using web-based     patient-provider communication and a remote glucose monitoring tool to improve     post-hospitalization glycemic control and patient self-care. The investigators hypothesize     that providing patients this web-based tool over a 4-week period after discharge to home will     result in more effective glycemic control compared to usual care, and that patients with     access to the tool kit will have a trend towards improved diabetes self-management and less     diabetes-related distress.   "
136660|NCT01495962|"     Damage control laparotomy (DCL) is a life saving maneuver used with success in trauma and     acute general surgery patients. The technique involves source control of sepsis and     hemorrhage with an abbreviated laparotomy. In other words, the surgical procedure is cut     short to allow for resuscitation in the ICU after the immediately life threatening pathology     is treated. Planned re-exploration is then performed within 24-48 hours. It is at this     procedure that the injuries are reconstructed. This technique, unfortunately, has several     complications implicit with its use including wound infection, enterocutaneous fistula     formation, and intra-abdominal abscess development.[1] Additionally, in patients whom primary     fascial closure is not achieved, extensive abdominal wall reconstruction will be required in     6-12 months. The key for preventing these complications is definitive closure of the     abdominal fascia, however, 10-50% of patients will have a planned ventral hernia with an open     abdominal wound at dismissal [1,2] Proven methods for decreasing the rate of planned ventral     hernia utilize tension in the midline to counter the effects of lateral abdominal muscular     retraction.[3,4,5] Despite these improvements, however, the planned ventral hernia rate     continues to be substantial.[2] Botulinum toxin a (BTX) is an FDA approved neuron modulating     agent which has been used extensively in cosmetic, motor and pain disorders over the past 20     years [6,7]. The toxin blocks acetylcholine and pain modulator release (calcitonin gene     related peptide and substance P) from the pre-synaptic cholinergic nerve terminal. The     peptides are unable to bind at their motor end plate receptors through a process that cleaves     proteins involved in the transport protein cascade. This results in flaccid paralysis and     neuromodulation of the abdominal wall muscles resulting in reduced lateral tension and pain.     Theoretically, this could increase the rates of primary fascial closure, improve pain     sensation, decrease the rate of complications associated with open abdomens all while     lowering the costs and need for future abdominal wall reconstruction.   "
136661|NCT01495949|"     During induction for cardiac surgery, patient hemodynamic stability is achieved by using     anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate.     Etomidate although has been used for a long time but its safety regarding cortisol synthesis     suppression is still doubtful. This study measures the changes in cortisol levels during     cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive     agents (etomidate and thiopentone). Recording data also include hemodynamic changes during     induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount     of insulin usage, length of ICU and hospital saty.   "
136662|NCT01495936|"     Patients requiring one lung ventilation (OLV) for open thoracic surgery will be ventilated     (breathing performed by a breathing machine) during anesthesia using a lung protective     ventilation strategy (small breath volumes at 6ml/kg). During thoracic surgery the     anesthesiologist is able to ventilate only one lung by inserting a special breathing tube,     allowing the surgeon to operate on the non ventilated (diseased) lung. In a randomized trial     two interventions used to improve blood oxygen levels during one lung ventilation will be     compared . The two interventions are:        1. Continuous Positive Airway Pressure (CPAP) applied to the non ventilated (non breathing)          lung and        2. Positive End Expiratory Pressure following a lung Recruitment Maneuver (RM-PEEP) to the          ventilated (breathing) lung.      CPAP is performed by applying a steady flow of oxygen to the non ventilated (non breathing)     lung at a continuous gentle pressure of 5cmH20.      To perform a Recruitment Maneuver (RM) the anesthesiologist inflates the ventilated     (breathing) lung with oxygen, holding the breath for 25 seconds so all the lung is opened up.     Immediately after the recruitment maneuver PEEP will be applied. PEEP is an action which also     helps keep the lung open, maintaining the benefits achieved by the RM. It is performed by     adjusting settings on the ventilator (breathing machine). The ventilator creates and applies     a gentle pressure (5cmH20) to the ventilating lung at the end of each breath.      The outcome measure will be the oxygen content in blood (PaO2), measured in mmHg, using blood     sample analysis.      The null hypothesis is that compared to CPAP, RM-PEEP does not significantly increase the     oxygen content of blood during OLV when using a lung protective ventilation strategy.   "
136721|NCT01495143|"     Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery.     Minimal invasive surgery is postulated to result in less muscle damage and better outcome.     The aim of this study is to monitor metabolic changes of the paraspinal muscle and to     evaluate paraspinal muscle damage during surgery using microdialysis (MD).   "
136663|NCT01495923|"     The purpose of this study is to determine whether pharmacotherapy or epidural steroid     injections are a better treatment for lumbosacral radicular pain.      142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be     randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will     be allocated to receive an epidural steroid injection (ESI; group I), with an equal number     allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded.     Follow-up will be through 3-months after treatment.   "
136664|NCT01495910|"     The purpose of this study is to determine the minimum dose of abiraterone acetate needed to     decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid     replacement for classic 21-hydroxylase deficiency.   "
136665|NCT01495897|"     Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive     muscle contractions of opposite muscles that lead to abnormal twisting movements or odd     postures. Essential tremor is a slowly progressive neurologic disorder characterized by the     appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or     essential tremor is not fully elucidated. Dystonia and essential tremor are associated with     dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the     cerebellum and cerebellar pathways has also been recently suggested.      The investigators propose to study 30 patients having a primary dystonia (15 DYT11     genetically documented), 15 patients having an essential tremor without deep brain     stimulation and 15 patients having an essential tremor with deep brain stimulation.A group of     30 healthy volunteers will be recruited and tested according to the same modalities. They     will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.      Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before     and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage     change in the mean saccade amplitude between pre-test and post-test.      Expected results:        -  no or fewer alteration of the performance to the adaptation task in the Parkinson group          than in the Essential Tremor group/ dystonia group.        -  abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor          group, providing further neurophysiological evidence of cerebellar dysfunction.   "
136815|NCT01494038|"     Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income     settings and can be a serious complication for HIV-infected pregnant women and their infants.     Isoniazid (INH) preventive therapy (IPT) is effective for HIV-infected adults, but the safety     of IPT in pregnant women is unknown. This study will evaluate the safety of IPT among     HIV-infected pregnant women.   "
136666|NCT01495884|"     This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic     breast cancer, following disease progression during, or after, treatment with trastuzumab and     taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on the     maximum tolerated dose (MTD) determined in the Phase I part of the study) plus Myocet™, 50-60     mg/m2 i.v q3 weeks).      Within the Phase I part, doses are assigned at registration according to the dose escalation     scheme.      The dose for the Phase II part of the trial will be based on the MTD established in the Phase     I part of the study.      Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity     of study therapy. Safety assessments will be performed every 3 weeks for the first 24 weeks.     Efficacy assessments (radiological examination) will be performed on all patients every 8     weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be performed at     weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments will be     performed every 12 weeks and at the end of treatment (disease progression, unacceptable     toxicity or patient withdraws consent).   "
136667|NCT01495871|"     Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It     has been called the signature wound of the Iraq war because of its frequency among troops.     TBI is associated with many chronic disabilities. Physical alterations include reduced     exercise tolerance and profound muscle weakness, whereas psychological alterations include     diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues     rely upon circulating blood amino acids as precursors for metabolic functions. The     investigators have shown that even one year after injury, plasma valine, an essential amino     acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The     investigators speculate that low plasma valine concentration contributes to chronic fatigue     after TBI, since valine and tryptophan compete for the same transporter into the brain, and a     low plasma valine concentration will allow more tryptophan to be transported. As a     consequence, increased brain tryptophan will increase serotonin production, which may     significantly contribute to the development of fatigue. Thus, the investigators will test if     restoring valine concentration in persons with TBI may reduce fatigue perception and improve     physical and neuropsychological function. Further, the investigators have previously shown     that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no     data are currently available in persons recovering from TBI. Thus,the investigators will also     test if EAA and/or valine can improve muscle mass in patients with TBI.   "
136668|NCT01495858|"     The objective of the study is to evaluate the efficacy and safety of a single oral dose of     naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with     postsurgical dental pain and phase advanced sleep.   "
136669|NCT01495845|"     The purpose of this study is to determine the feasibility of pharmacogenomics testing in a     community pharmacy using clopidogrel as an example. The investigators hypothesize that this     testing is feasible in this setting.   "
136670|NCT01495832|"     The Canadian population, as is the case in most developed countries, is ageing and becoming     increasingly overweight and/or obese. Both ageing and obesity are associated with reduced     cognitive performance which can impact adversely on the ability to undertake daily activities     and increases the risk of loss of independent living and reduced quality of life. The     investigators predict that consumption of ½ cup of pulses per day for 12 weeks will improve     cognitive function in older overweight/obese adults and thus decrease the rate of cognitive     decline that occurs in this at-risk population.   "
136722|NCT01495130|"     This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors     during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such     as ultrasound, may help find prostate cancer and find out how far the disease has spread     during surgery   "
136723|NCT01495117|"     The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone     iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver,     hepatobiliary, small or large bowel, stomach) is effective.   "
136671|NCT01495819|"     The proposed study will examine the threshold for nicotine self-administration (NSA) using     five different nicotine doses in young adult male and female non-dependent smokers (light and     intermittent smokers or LITS). We propose a double-blind, placebo-controlled study that will     enroll 195 individuals, targeting a total of 72 completers (36 male and 36 females). In each     of the five experimental sessions, smokers will be randomly assigned to one of the five doses     of nicotine (0.0125, 0.025, 0.05, 0.1 and 0.2 mg/70 kg). The highest dose, 0.2 mg/70 kg,     corresponds to nicotine delivered by about one or two puffs of a cigarette. At the beginning     of each experimental session, smokers will sample the assigned both the nicotine dose for     that experimental session, and the placebo (saline) dose, followed by the opportunity to     choose between nicotine and placebo for a total of ten choices over a 150-minute period. The     main outcomes will be threshold dose (the minimum dose of nicotine that is self-administered     more than placebo) and the slope of dose-response for nicotine self-administration (changes     in nicotine self-administration per unit change in nicotine dose). We will also collect     measures of nicotine intake (cotinine), nicotine clearance (3-hydroxycotinine (3-HC) /     cotinine), and self-report drug effects   "
136672|NCT01495806|"     Background: Functional abdominal pain disorders (FAPD) are common in school-aged children;     however, there is no reliable treatment.      Aim: To determine the efficacy and safety of glucomannan for treating FAPD in children.      Trial Setting: Department of Pediatrics, The Medical University of Warsaw.      Intervention: Patients will be enrolled in a double-blind, randomized controlled trial in     which they will receive either glucomannan (10g) or placebo for 4 weeks.   "
136673|NCT01495793|"     This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple     administrations of the rotigotine transdermal system. The study was conducted in adolescent     subjects (13 to <18 years of age) with idiopathic Restless Legs Syndrome (RLS).   "
136685|NCT01495637|"     The GIFT study is a prospective, multi-center, interventional trial using the drug GM-CSF for     the reversal of innate immune suppression in critically injured children. The study will be     conducted in two phases, a dose-finding phase then an efficacy phase. The dose-finding phase     is the current active phase of the study. The central hypothesis of the study is that     immunomodulation with GM-CSF will result in reduction in the risk of nosocomial infection     after critical injury in high-risk children through safe, rapid, and sustained improvement in     innate immune function.   "
136675|NCT01495767|"     Data about psychodynamics in uveitis patients are scare. A negative impact of disease is     described not only in adult patients with active, but also with quiescent disease. During     adolescence even less is known about psychodynamics although this is an especially sensible     and challenging stage of life. Given the assumption that juvenile patients with quiescent     disease still could suffer from emotional distress, this would require special attention.      In this study the investigators evaluate the impact of juvenile uveitis on HRQoL and     attempted to identify clinical and demographic factors contributing to an impaired health     status. The investigators limit the study to patients with quiescent uveitis and good visual     function in at least one eye to exclude additional negative stressors. As there are no     validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the     investigators use age-appropriate generic instruments. This should allow obtaining an     overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether     psychological interventions should be offered to this sensitive patient group.   "
136676|NCT01495754|"     The purpose of the study is to investigate whether different doses of caffeinated coffee     consumption has acute effects on subjective appetite feelings, energy intake and biochemical     markers related to appetite, inflammation and glucose metabolism compared to water     consumption in normal weight and overweight/obese participants.   "
136677|NCT01495741|"     This study will assess asenapine (Sycrest®) use in participants with bipolar disorder;     comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine     (Zyprexa®). The occurrence of identified and potential clinically important risks will also     be assessed.   "
136678|NCT01495728|"     Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust     manipulation will demonstrate immediate and short term significant clinically important     changes in outcomes when compared to the sham manipulation group.   "
136679|NCT01495715|"     The objective of the study is to determine whether administration of idebenone can shorten     the time to improvement of visual acuity in patients with chronic vision loss due to LHON.   "
136680|NCT01495702|"     This study will evaluate the noninferiority of Stribild®     (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF))     single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse     transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50     copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also     evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of     treatment.   "
136681|NCT01495689|"     Cigarette smoking is the most harmful and quitting smoking is very difficult. Despite     quitting, it is very difficult to stay quit for long term. In Ottawa the investigators are     very lucky to have designed and developed the Ottawa Model for Smoking Cessation (Ottawa     Model). This project is an end result of pain staking research. The Ottawa Model has been     implemented very successfully to the hospitalized patients and has shown very promising     results of higher quitting rates.      Our objective is to modify the Ottawa Model to suit the needs of patients attending     out-patient respirology clinics. The investigators aim to apply the modified Ottawa Model     along with the SmartCard to the adult smokers who attend the investigators out-patient     Respirology clinic at the Ottawa Hospital.      The investigators aim to train a nurse in clinical aspects and implementation of the     protocols related to the Ottawa Model. The trained nurse will contact the smokers attending     the clinic. Those subjects willing to participate in this study will be divided in to two     groups. One group of subjects will get counseling and SmartCard on the day of the clinic and     follow-up phone calls. The SmartCard is worth $110 toward the purchase of quit smoking     medications (i.e. nicotine patch/gum, varenicline, or bupropion). The subjects can re-deem     the card at the investigators hospital pharmacy. Those in the control group will be     followed-up as the investigators are currently doing i.e. with standard smoking cessation     counseling from the clinic physician and the nurse, +/- prescription for smoking cessation     aids without access to the study nurse and the extra counseling or SmartCard. The     investigators aim to find increased quitting rates in the group getting on-site access to the     smoking cessation aids with the Smartcard and counseling.      There are no studies implementing the Ottawa Model along with the SmartCard in out-patient     respirology setting so far. The Ottawa Model has proven to be very successful in the     in-patient subjects. Thus, the investigators believe, the investigators can modify the Ottawa     Model and make it fit the out-patient Respirology setting and increase the quitting rates.   "
136682|NCT01495676|"     If radical cystectomy remains the standard of care for muscle invasive bladder cancer,     consequences of this surgical procedure are often harsh. Over the past years, concurrent     chemo-radiotherapy has imposed itself as an alternative treatment. Published data on     concomitant radiochemotherapy (radiotherapy/cisplatin or     radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder     preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall     survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and     systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing     effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer     activities on urothelial diseases and has a synergetic activity with cisplatin. The     investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and     twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The     objective of the present study is to evaluate the combination of radiotherapy + cisplatin +     gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial     cancer patients.   "
136683|NCT01495663|"     The purpose of this study is to determine the recommended dose of I-131-CLR1404, a     radiolabeled therapy compound, for treating subjects with cancer that does not respond to     treatment or has returned. The identified recommended dose in this study will be used as the     optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase     clinical development.      Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the     study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase,     subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on     the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of     biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated,     the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects     will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be     in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable     toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.      All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to     injection of the dosimetric dose, and continuing for 14 days after the administration of the     therapy dose.   "
136684|NCT01495650|"     Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining     regular dietary counseling and tailored physical activity is associated with reduced     cancer-related fatigue and can improve quality of life and body weight control. We propose to     conduct a randomized controlled trial which purpose is to evaluate the effect of an     intervention combining physical exercise and nutritional therapeutic education on     cancer-related fatigue. To gain behavioral change towards PA and nutrition habits,     interventions will take place within hospitals, on the same days of adjuvant treatments.   "
136686|NCT01495624|"     Patients undergoing rotator cuff repair or subacromial decompression at the investigators     institution are frequently hospitalized overnight due to inadequate pain relief after     resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators     usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours     without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of     prolonging analgesia from a brachial plexus block without the extra equipment and logistical     difficulties of indwelling catheters would benefit both patients and caregivers. A potential     approach is use of adjuvant drugs that prolong block duration when added to the local     anesthetic.      In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate     glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory,     analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their     effects by inhibition of phospholipase A2 as well as changes in cell function induced by     glucocorticoid receptor activation. Although associated with significant toxicity when     administered in large doses for long periods, emerging literature suggests that a single     perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at     the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging     regional anesthetics. Available data thus suggest that combining glucocorticoids with local     anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown     to reduce postoperative pain. This raises the question whether the beneficial effects of     adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated     at least in part by systemic action. Previous trials, however, have not addressed this     important issue. If this beneficial effect of analgesic duration is mediated by systemic     action, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no     study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to     confirm the safety of this route, achieving similar results with more conventional     administration would be desirable for two reasons. First, conventional intravenous dosing is     convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and     well-studied. Second, equivalent (or not equivalent) results from systemic dosing would     provide valuable information about the mechanism behind dexamethasone's effect on block     duration.   "
136687|NCT01495611|"     The purpose of this research study is to identify factors and genes (the DNA material that     determines the makeup of the human body) that may be associated with how children respond to     pain medication. Specifically, the investigators want to study factors that may be associated     with pain sensitivity, morphine requirement after surgery and side-effects from morphine and     other pain medications. The investigators expect that the information obtained in this     research study will help us to develop more effective, safe, and tailored treatment options     in the future.   "
136688|NCT01495598|"     Background:      - Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by     mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote     tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the     growth of new blood vessels that help cancer grow. Researchers want to see if pomalidomide     can treat Kaposi sarcoma, a rare and potentially fatal skin cancer. Because Kaposi sarcoma     may be associated with human immunodeficiency virus (HIV) infection, researchers want to test     the drug in people with and without HIV infection.      Objectives:      - To see if pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with     or without HIV.      Eligibility:        -  Individuals at least 18 years of age who have Kaposi sarcoma.        -  Participants may or may not have HIV infection.      Design:        -  Potential participants will be screened with a medical history and physical exam. Blood          and saliva samples will be taken and a chest X-ray will be performed. A skin biopsy of a          Kaposi sarcoma lesion may be performed if one has not already been done. Other imaging          studies may be performed if needed.        -  Participants will take pomalidomide capsules every day for 3 weeks, followed by a 1-week          break. These 28 days are one cycle of treatment.        -  Participants will have up six cycles of treatment, unless the lesions completely resolve          sooner. If there are signs of improvement after six cycles but the lesions are not          completely gone, up to another six cycles of treatment may be given.        -  Treatment will be monitored with frequent blood tests and other studies including          photograph and other imaging of skin lesions.        -  Participants will have regular follow-up visits for 5 years after stopping treatment....   "
136689|NCT01495585|"     Background:        -  Chronic hepatitis D is a severe disease of the liver caused by infection with the          hepatitis D virus. The hepatitis D virus can only infect a person who also has hepatitis          B; therefore, people with delta hepatitis have both hepatitis B and hepatitis D virus          infection. Most people with hepatitis D eventually develop cirrhosis, which causes          scarring and damage to the liver. There is currently no effective treatment for chronic          hepatitis D.        -  Lonafarnib is a drug that was originally designed to treat different types of cancer. It          may be able to prevent the hepatitis D virus from reproducing itself. However, it has          not been tested on people with hepatitis D. Researchers want to study different doses of          lonafarnib to see how they affect virus levels and other symptoms of hepatitis D.      Objectives:      - To test the safety and effectiveness of lonafarnib as a treatment for chronic hepatitis D.      Eligibility:      - Individuals at least 18 years of age who have chronic hepatitis D.      Design:        -  Participants will be screened with a medical history and physical exam. They will have          blood and urine tests, eye exams, and imaging studies of the liver and gall bladder. A          liver biopsy may also be performed.        -  Participants will receive either lonafarnib or placebo twice a day for 28 days. For the          first 3 days, participants will stay in the hospital to have frequent blood tests.          Participants will have four more clinic visits (on days 7, 14, 21, and 28) for blood and          urine tests. Eye exams and heart function tests will also be given. Men may be asked to          provide sperm samples for further testing.        -  After the 28 days of treatment, participants will stop taking the drug or placebo. They          will have regular followup visits for up to 6 months after stopping treatment....   "
136690|NCT01495572|"     Background:      - Some cancer treatments collect a patient s own blood cells to use as specialized     cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood     lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with     PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can     survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new     cells grow. Researchers want to see if special white blood cells that recognize a specific     protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART)) can     cause tumors to shrink. These white blood cells will be tested with and without aldesleukin.      Objectives:        -  To test the safety and effectiveness of white blood cells that target MART in the          treatment of melanoma.        -  To test white blood cells that target MART with and without aldesleukin.      Eligibility:      - Individuals at least 18 years of age who have melanoma that has not responded to standard     treatments.      Design:        -  Participants will be screened with a medical history and physical exam. Blood and urine          samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging          scans will be performed.        -  Participants will provide white blood cells through leukapheresis. Researchers will          attempt to isolate white blood cells that recognize MART        -  Seven days before the start of treatment, participants will have chemotherapy.        -  After the last dose of chemotherapy, participants will receive the MART reactive PBL          cells. Filgrastim doses will also be given to help white blood cell counts return to          normal. Participants will have frequent blood tests.        -  Participants who are able to have aldesleukin treatment will start within 24 hours after          receiving the MART reactive PBL cells. Treatment will continue for up to 5 days.        -  Participants may have an optional tumor or lymph node biopsy to study the effects of          treatment.        -  If the tumor continues to grow after MART PBL treatment, participants may have one more          round of cell collection and treatment.        -  Participants will have followup visits for up to 6 months after receiving the MART          reactive PBL treatment.   "
136691|NCT01495546|"     In Brazil, several hip surgeries performed, especially total knee arthroplasty, which     represents 1.5 million procedures (Penedo, New, 2007). The rehabilitation of these     individuals is slow with respect to the march because it requires an aid and not to use the     operated leg as support for three weeks, according to conventional methods. After the third     week, the support becomes part and after that period (sixth week), the support becomes total.     Therefore, and in order to provide better quality of life, the goal of this work is to     compare the march in 40 patients divided into two groups of 20 subjects each. In the control     group, the treatment approach is the traditional, i.e., without immediate loading, while the     other charge will be applied immediately in the operated limb. In order to verify the     possible gain in the quality of life of these patients, the SF-36 will be applied. The march     will be assessed with the Time Up and Go test and the force platform and the Harris Hip score     analyze the function of the hip. Individuals will receive such care at the Institute of     Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of São     Paulo (IOT - HC - USP). The results of comparisons between the two groups and the clinical     findings obtained will be subjected to appropriate statistical tests, guided by the     principles of evidence-based clinical practice, seeking to facilitate and improve the lives     of these individuals so they can move freely.   "
136693|NCT01495520|"     Patients with ischemic heart disease often report multiple symptoms, including angina and     palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's     effect on multiple ion channels. It remains unknown, however, whether the favorable effects     of ranolazine on symptoms and arrhythmias are maintained over time. Aim of this study is to     test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status     of patients with ischemic heart disease by reducing the occurrence of palpitations.   "
136694|NCT01495507|"     The field of patellofemoral disorders and accordant therapeutical interventions is a high     turnover research field. It is important to verify the clinical outcome with appropriate     measuring tools. There is evidence that the Kujala score is a reliable and widely used     measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used     in many studies investigating patellofemoral disorders - also in german speaking patient     groups. Unfortunately, we are not aware of a validated german version of the Kujala score.     Other relevant knee outcome scores were already successfully translated into german language     and validated by previous investigators.      So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala     score for use in German-speaking individuals with patellofemoral instability. It is     hypothesized that the german version of the Kujala score shows:        -  High divergent construct validity as determined by significant differences between          patients and controls (hypothesis 1)        -  High convergent construct validity as determined by significant correlations with other          relevant scoring systems (hypothesis 2)        -  High reliability (hypothesis 3)        -  High responsiveness (hypothesis 4)   "
136695|NCT01495494|"     This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes.     Prototypes were produced as an improvement to the currently marketed product.   "
136696|NCT01495481|"     The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the     acute termination of Supraventricular Tachycardia (SVT).   "
136697|NCT01495468|"     This was a multicenter, randomized, open-label, parallel controlled phase III study, compared     pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration     formulation).      All the subjects were randomized into two groups, test group (PEG somatorpin) and control     group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled     in control group. Considering the case loss during the clinical study, 20% of the patients     were added in each of the group, that is 240 children were in test group and 120 children     were in control group, totally 360 children were enrolled in the phase III clinical study.      Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point     of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time     point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the     evaluation would be made when the treatment is finished.   "
136698|NCT01495455|"     Osteoarthritis is by far the most common joint condition and the single largest cause of     disability in the older population. The investigators still have a poor understanding of the     nature of osteoarthritis and factors that influence its development and progression.     Identification of biochemical markers that relate to cartilage loss, bony overgrowth and     other features that occur with osteoarthritis will advance our understanding. Over the last 5     years analytical methods have developed to measure a range of different biomarkers. This     pilot study will use these analytical methods to measure biomarker levels in joint fluid,     urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers.      This study will provide novel pilot data on the changes in the composition of the synovial     fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the     knee is a suitable joint for study because of its accessibility to clinical assessment, joint     aspiration and imaging.   "
136699|NCT01495442|"     The primary objective is to admix a radiolabel with albuterol sulphate for incorporation into     the Handihaler® device for inhalation studies. This will allow for the investigators to     determine the regional lung deposition of drug inhaled from the standard Handihaler® device     compared to a novel modification of the device to provide more effective dispersion and     aerosolization of the coated albuterol powder. The new mechanism of action for     proof-of-concept testing consists of a bead (5.1 mm; expanded polystyrene foam) coated with     drug powder, as opposed to the standard lactose formulation-filled capsule.   "
136700|NCT01495429|"     The investigators aim to compare the complications between centrally and peripherally     inserted central venous catheters in neurological intensive care unit patients. The study     hypothesis is that peripherally inserted catheters will have more cumulative complications     due to venous thrombosis.   "
136701|NCT01495403|"     This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with     patients having cramps due to their cirrhotic liver disease.   "
136702|NCT01495390|"     The purpose of this study is to collect biofluid samples for the banking and usage in ALS     research. Through comparison of these samples, the researchers hope to learn more about the     underlying cause of ALS, as well as find unique biological markers, which could be used to     develop new therapies.   "
136703|NCT01495377|"     The purpose of this study is to determine weather remifentanil induced swallowing     difficulties increase risk for pulmonary aspiration.   "
136704|NCT01495364|"     This study will assess the safety and efficacy of intracoronary artery administered     autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial     infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem     cell treatment group to the control group in terms of the occurrence of AE's, SAE's and Major     Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured     quantitatively by gated single photon emission computed tomography myocardial perfusion     imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac MRI     in addition to other endpoints.   "
136705|NCT01495351|"     The combination of PARP inhibitor (ABT-888) with a proteasome inhibitors (bortezomib) have     demonstrated significant anti-myeloma effects in preclinical lab and animal studies. The goal     of this phase I trial is to evaluate in patients with relapsed or refractory multiple myeloma     the safety, toxicity profile and tolerability of ABT-888 (Veliparib) administered on a     schedule including twice daily oral dosing for 14 days followed by 1 week rest in combination     with standard dosing of Bortezomib.   "
136707|NCT01495325|"     Exposure to air pollution is a well established risk factor for the development of heart     disease. Firefighters are exposed to excess air pollution in the form of wood smoke during     the extinguishing of forest or woodland fires. Heart attacks in on-duty firefighters have     been linked to specific duties and in particular fire suppression, but the reasons for this     increase in risk are not well understood. Exposure to wood smoke may alter blood vessel     function and increase blood clot formation to explain the link between fire suppression and     heart attacks.      The investigators wish to determine the effect of exposure to wood smoke at concentrations     found at the perimeter of a woodland fire on blood vessel function and clotting in healthy     non-smoking male professional firefighters or volunteers. Volunteers will be studied before     and after inhalation of wood smoke or clean air for one hour in a purpose built whole-body     exposure chamber. The investigators will perform comprehensive vascular assessments     thereafter.      Understanding the effects of wood smoke on the blood vessels and clotting will be an     important first step in helping to protect firefighters from heart disease. Through research,     the investigators hope to identify methods to minimise the risk of heart attacks in     firefighters and understand the health effects of a major source of air pollution that is     relevant to the general population.   "
136708|NCT01495312|"     The purpose of this study is to determine the relationship between Intraocular Pressure (IOP)     fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED     Triggerfish®), during two 24-hour periods after selective laser trabeculoplasty (SLT) for     routine treatment of glaucoma.   "
136709|NCT01495299|"     The purpose of this study is to determine the relationship between intraocular pressure (IOP)     fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED     Triggerfish®), during two 24-hour periods, before and after cataract surgery. This device has     previously been investigated and shown to be safe and well tolerated.   "
136724|NCT01495104|"     This open-label, fixed-sequence, two-period study will assess the effect of multiple dose     valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male     volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period     of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with     concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.   "
136725|NCT01495091|"     The main purpose of this study is to examine whether changes in biomarkers during exercise     are related to coronary artery disease demonstrated by coronary angiography or     echocardiography.   "
136726|NCT01495078|"     The primary objective of the study is to determine the effect of automated daily selfreported     symptom and weight, blood pressure and heart rate monitoring and clinical follow-up     videoconference comigrate with clinical follow-up face in specialized hospital unit in     reducing heart failure non-fatal events.   "
136710|NCT01495286|"     This research study represents a pilot, open arm study that will evaluate the safety of using     Non−invasive Electrical Stimulation of Acupuncture Points (NESAP) in 42 newborn infants less     than 3 days of age who require heel sticks for clinical blood sampling. The investigators     plan to enroll 51 infants into the study in order to obtain 42 completed infants. Two sub     studies will precede the main safety study, with 6 infants in each sub study and 30 infants     in the main study. These two sub studies will use electrical stimulation intensities that are     a fraction of the planned intensity of electrical stimulation that will be used during the     main part of the study.      The clinical trial will be performed at the University of Arkansas for Medical Sciences     Hospital (Little Rock, AR). The study will evaluate the pain response to heel stick routinely     used to obtain This blood from 30 term neonatal infants, ages 37 to 42 weeks Electrical     stimulation will be applied at appropriate acupuncture points using a very low current for 10     minutes, routine for procedural pain. The response to pain will be assessed using pain scales     and physiologic changes.      The investigators hypothesize that the NESAP procedure is safe in newborn infants undergoing     a routine heelstick.   "
136711|NCT01495273|"     Various medical procedures require different objects to be inserted into the airway; for     example, a bronchoscope - a fibreoptic camera device - can be guided down the windpipe to     gain real-time images of the airway. Since inserting objects down the throat is uncomfortable     for most patients, doctors have several options, one of which is putting the patient to sleep     using general anesthetic before inserting something into the windpipe. This may not always be     the best option, especially in cases where the patient needs to be awake during the     procedure. In these cases, the doctor may 'freeze' the windpipe before inserting a scope or a     tube into the airway. For this, the doctor inserts a needle through the front of the neck and     injects local anesthetic. Inserting a needle into the windpipe comes with some risks to the     patient, and the doctor wants to avoid puncturing nearby structures, such as arteries, veins,     and the esophagus. The investigators have come up with a new method for accurately guiding a     needle into the airway that will alert the user when they have successfully placed the needle     tip in the windpipe. The investigators hypothesize that this new method will prove to be     beneficial to clinicians and emergency medical personnel who need a fast, easy, and reliable     way to insert a needle into the airway.   "
136712|NCT01495260|"     X-linked adrenoleukodystrophy is a rare, demyelinating and neurodegenerative disorder, due to     a loss of function of a fatty acid transporter, the peroxisomal ABCD1protein. Its more     frequent phenotype, the adrenomyeloneuropathy in adults, is characterized by axonal     degeneration in spinal cord, spastic paraparesis and a disabling peripheral neuropathy.     Actually, there is no efficient treatment for the disease. Our work in the last twelve years     dissecting the physiopathological basis of the disorder has uncovered an involvement of the     oxidative stress early in the neurodegenerative cascade. In a preclinical trial we have     identified an antioxidant cocktail that efficiently reverse the clinical symptoms and the     axonal degeneration in the mouse model for the disease. We propose the translation of the     results to an open trial to test the tolerance and effectiveness of these drugs in the     correction of the previously identified oxidative lesion biomarkers, as a first step to a     randomized versus placebo, multicentric and international trial. You will be clinically     explored and assessed in the Hospital Universitari of Bellvitge (HUB) using clinical scales     for spasticity, disability, electroneurogram and cranial and spinal Nuclear Magnetic     resonance (NMR). The information will be collected in a data base that will be of great value     to improve the present attention and the future follow-up to facilitate your inclusion in     therapeutic randomized, double blind, against placebo clinical trials.   "
136713|NCT01495247|"     This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients     that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase     Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of     BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is     established the second part (phase II) will start. Phase II will evaluate the efficacy and     the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.   "
136714|NCT01495234|"     This study is designed to generate data relating to patient safety, bone generating activity     associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate     the feasibility of conducting a larger clinical trial in a patient population requiring     spinal fusion.   "
136715|NCT01495221|"     This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal     aflibercept injection in patients who have been previously treated for AMD and have     persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.   "
136716|NCT01495208|"     This is an open label study to evaluate the efficacy of intravitreal aflibercept injection     2mg in patients with a persistent FVPED despite at least 6 consecutive injections with     ranibizumab 0.5 mg.   "
136717|NCT01495195|"     No medications are currently available for treatment of psychostimulant addiction, a     compulsive preoccupation with use of cocaine and related compounds. Donepezil is a medication     that is currently prescribed for Alzheimer's disease, and selegiline is a medication used for     treatment of Parkinson's Disease. Both of these medications can decrease the amount of     cocaine injections that laboratory animals choose to inject by vein. This project will     determine if combined treatment with donepezil and selegiline can also decrease     cocaine-motivated behavior for human subjects in a laboratory setting.   "
136718|NCT01495182|"     The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in     healthy, adult volunteers.   "
136719|NCT01495169|"     Tolerability, undertstanding of the action of the drug in the body, and understanding the     effect of the drug in adolescent patients needing treatment with an antipsychotic medication   "
136720|NCT01495156|"     The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial     comparing two treatment strategies in adolescents with mania and prominent psychotic     features. One group will receive a second generation antipsychotic (SGA) and placebo and the     other will receive a SGA and lithium.      The primary double-blind phase of the study will last 8 weeks, followed by a 24-week     extension-phase.   "
136842|NCT01493687|"     The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its     vehicle when applied once daily, at bed time, during a 12 week period in subjects with     Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.   "
136727|NCT01495065|"     This is a two-part study. Part A is a three-period study in approximately 24 healthy male     Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to     investigate the safety, tolerability, and pharmacokinetics of single ascending intravenous     doses of GSK2251052. Period 3 is a single blind, placebo controlled, repeat fixed dose design     to evaluate the safety, tolerability and pharmacokinetics of multiple intravenous doses of     GSK2251052 for 12 days. The selection of the repeat IV dose will be based on the results from     Periods 1 and 2. Japanese subjects will be stratified based on their metabolic genotype,     polymorphic or wild-type for ADH and ALDH. Caucasian subjects are not anticipated to have     these enzyme polymorphisms and therefore will not be stratified.      Part B is a two cohort, single-blind, randomized, placebo-controlled, dose-rising, repeat     dose study in approximately 24 healthy male and female subjects to evaluate the safety,     tolerability, and pharmacokinetics of supratherapeutic IV doses of GSK2251052 for 10 days.     Cohort 1 subjects will be randomized to receive 2250 mg of GSK2251052 or placebo and Cohort 2     subjects will be randomized to receive 3000 mg GSK2251052 or placebo. The decision to conduct     Cohort 2 of Part B will be based on the available toxicology cover results from ongoing     preclinical toxicity studies.   "
136728|NCT01495052|"     Dietary modification is of great essential for the prevention and treatment of type 2     diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential     benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked oat     (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of     organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.      After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial     of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes.     Participants would be randomly assigned to one of the four following groups: usual care group     (only basic health advice, no other interventions), diet group (systematic education,     structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus     replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for years     would be carried out to predict the long-term effects of ONOG plus diet intervention on     patients with type 2 diabetes.      The investigators hypothesized that ONOG combined with diet would have better effects on     glycaemia and insulin resistance control in addition to those yielded by diet or usual care.   "
136729|NCT01495039|"     Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida     colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is     still a matter of debate.      Methods. Randomized, single-center trial studying single drug (nystatin) versus control in     surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU     admission (T0) and subsequently every 3 days (T3, T6, T9…). The primary evaluation criterion     was the time course of colonization index (CI) during ICU stay.   "
136744|NCT01494844|"     This research study will test the comfort of two noninvasive respiratory monitoring sensors     (the connection to a monitor worn by a person—not the monitor). The two sensors, Masimo     Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by     the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting.     People who enter into the study will wear the two interfaces, one after the other, for 20     minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and     rate the comfort of each with a seven question survey. A total of 30 participants will be     recruited.   "
136730|NCT01495026|"     This study is an open-label, randomized, single dose, multi-stage, cross-over study in     healthy male subjects of North East Asian ancestry. The aims are to:        -  evaluate the pharmacokinetic parameters of several formulations of a fixed dose          combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg)          relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin          hydrochloride 0.2 mg tablets in the fasted state in order to define a formulation which          is bioequivalent to a 0.2 mg orally disintegrating tamsulosin tablet, (Harnal-D Tablets)        -  determine the effect of food on the relative bioavailability of tamsulosin in the FDC          product which is assessed to be bioequivalent to Harnal-D Tablets in the fasted state        -  assess the effect of water on the relative bioavailability of tamsulosin in Harnal-D          Tablets in the fasted state        -  assess the safety and tolerability of dosing with the different FDC capsule formulations          Subjects will receive single oral doses in at least one treatment period; treatment          periods will be separated by a 5-10 day washout period. Blood samples for          pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be          assessed by measurement of blood pressure, heart rate and review of adverse events. Each          stage of the study will enrol 18 subjects to ensure 16 complete. Subjects may consent to          participate in more than one stage.   "
136731|NCT01495013|"     The aim of this 20 week study is to show that glimepiride/atorvastatin fixed dose combination     tablet is safe and as effective as atorvastatin + glimepiride combination taken as separate     tablets, in improving glycaemic control (glycated haemoglobin, HbA1c) and cholesterol levels     (Low-density lipoprotein, LDL) in diabetic subjects, who are inadequately controlled on a     stable dose of metformin. Eight dose combinations will be included.   "
136732|NCT01495000|"     The purpose of this study is to determine if denosumab is effective in increasing bone     mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.   "
136733|NCT01494987|"     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to     determine the effect of ranolazine when added to glimepiride on glycemic control in adults     with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current     treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.   "
136734|NCT01494974|"     The purpose of this study is to compare the success rates and complications of two models of     Ahmed glaucoma implants (FP7 and FP8) in patients with pediatric glaucoma.   "
136735|NCT01494961|"     ANRS 12127 Prenahtest is an intervention trial conducted in four countries (Cameroon,     Dominican Republic, Georgia and India), where pregnant women are randomized during prenatal     care to receive either standard post-test HIV counseling, or an innovative intervention     called couple-oriented post-test HIV counseling (COC).      The aim of the COC intervention is to empower women to communicate with her male partner     about HIV, and HIV testing in particular, and encourage him to return for HIV testing and/or     couple HIV counseling (where both couple members are counseled together).      Prenahtest is the first randomised trial testing a prenatal intervention to increase partner     HIV testing.   "
136736|NCT01494948|"     The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is     associated with the presence or development of allergic disease.   "
136843|NCT01493674|"     The aim of this study was to determine the effect of folic acid supplementation on     homocysteine levels in a group of patients with eating disorders (ED) with low folate intake.     The secondary aims were to evaluate the evolution on cognitive and depressive status after     the intervention.   "
136738|NCT01494922|"     The purpose of this study is to provide subjects who participated in prior studies of EXC 001     the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.   "
136739|NCT01494909|"     Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An     impaired intestinal digestion and absorption capacity is one of the main factors responsible     for the malnutrition in CF. This impairment starts early in life, leading to malnutrition,     muscle weakness, impaired immune and lung function associated with poor prognosis. As low BMI     and body weight is strongly associated with morbidity and mortality, a reduction in weight     loss in CF and its manifestations would save the healthcare system substantially per year.     Simple methods to measure the digested portions and utilization of nutrients and the     effectiveness of pancreatic enzyme preparations and medications in CF are not available.     Developing a panel of methods to accurately measure gut digestion, absorption and function     will lead to studies optimizing nutritional regimen and pancreatic enzyme replacement therapy     in CF. Furthermore, it will provide detailed insight in the disease and age related     mechanisms of gut dysfunction in CF. Finally, it will provide required information that will     lead to implement new strategies to improve gut health in order to enhance nutritional     status, quality of life and survival.      The hypothesis is that intestinal macronutrient digestion, absorption and function in CF can     be quantified by an innovative panel of methods using stable isotopes. With this panel of     methods, information can be obtained on the effect of disease progression on lipid, protein     and glucose digestion and absorption and on gut function in CF as well as in other diseases     and conditions characterized by a compromised gut. Furthermore, the optimal nutritional     regimen and pancreatic enzyme therapy if applicable can be evaluated in these diseases. In     the present study the investigators will study: 1. Pediatric patients with CF at Arkansas     Children's Hospital; 2. Adult patients with CF at University of Arkansas for Medical     Sciences. 3. Healthy control subjects. Diagnosis of CF is made based on universal diagnostic     criteria. All CF patients are characterized by abnormal lipid digestion based on clinical and     or laboratory (72 hour fat analysis or fecal elastase measurement) diagnosis, and requiring     pancreatic enzyme replacement therapy, and no presence of unstable metabolic diseases.     Additional criteria for the CF pediatric inpatients are: admitted to ACH for treatment of     exacerbations of CF disease, clinically stable. The CF outpatients are stable outpatients     with pancreatic insufficiency.   "
136740|NCT01494896|"     The purpose of this study is to see how inhaled treprostinil sodium (Tyvaso) affects the     amount of air and blood that reach the alveoli, or tiy air sacs, in the lungs of patients     with Group 1 Pulmonary Arterial Hypertension with concomitant Chronic Obstructive Pulmonary     Disease (COPD).   "
136741|NCT01494883|"     The aim of the current study is to examine the (cost)effectiveness of mindfulness based     stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer     and their partners.   "
136742|NCT01494870|"     The primary objective of this study is to propose new treatment algorithm (strategy) for     patients with Acute Coronary Syndrome (ACS) and left bundle-branch block (LBBB).   "
136743|NCT01494857|"     The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a     fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with     ulcerative colitis (UC) naive to treatment with biologics.   "
136745|NCT01494831|"     The purpose of this study is to evaluate, in a randomised control trial (RCT), the     effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing     psychological distress in former child soldiers and other war-affected children in the     Democratic Republic of Congo (DRC).   "
136746|NCT01494818|"     The purpose of this study was to assess and compare the effect of the repeated usage of two     different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting     system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with     silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific     aspect of interest was the effect on the ocular tissue, in particular the eyelids and their     associations with the contact lens surface wettability and surface contamination.   "
136748|NCT01494792|"     The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and     Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of     Group A Streptococcus when compared to culture.   "
136749|NCT01494779|"     The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic     effect between two preparations of somatropin (T and C) after a single administration of 5 mg     in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h,     AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1     presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).   "
136750|NCT01494766|"     Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter,     dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is     subsequently and avidly converted into dopamine. It is well known that dopamine deficiency     leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine     agonists and L-dopa to be effective in controlling symptoms. No studies to date have been     done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine     the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in     treating RLS in addition to adding another possible agent to the investigators arsenal of     treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will     be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated,     in increments of 750 mg every week in patients who meet the inclusion criteria for RLS.     Patients' symptoms will be monitored on a weekly basis for six weeks.   "
136751|NCT01494753|"     The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345     versus an active comparator.   "
136752|NCT01494740|"     The aim of this study is to investigate the immunogenicity and safety of the inactivated     split-virion vaccine in infants.   "
136753|NCT01494727|"     The objectives of this study are:        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge          10/160mg after a single oral administration in healthy male volunteers        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis          Exforge 10/160mg after a single oral administration in healthy male volunteers   "
136754|NCT01494714|"     The purpose of this study is to evaluate skin irritation and photo irritation of JNJ     10229570-AAA on intact skin of Japanese healthy male participants.   "
136755|NCT01494701|"     This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics     of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with     Spinal Muscular Atrophy (SMA).   "
136756|NCT01494688|"     This open-label, multicenter, dose-escalation study will assess the safety, tolerability,     pharmacokinetics and pharmacodynamics of RO5509554 in participants with advanced solid tumors     which are not amenable to standard treatment. In Part I (Dose Escalation), multiple ascending     doses of RO5509554 will be administered as monotherapy in participants with solid tumors.     Participants with locally advanced and/or metastatic ovarian (including fallopian tube) and     breast carcinoma will receive multiple ascending doses of RO5509554 in combination with     paclitaxel. In Part II (Expansion Cohort), RO5509554 will be administered as monotherapy to     participants with locally advanced and/or metastatic Pigmented Villonodular Synovitis     (PVNS)/Tenosynovial Giant Cell Tumor (TGCT), soft tissue sarcoma or malignant mesothelioma,     ovarian (including fallopian tube), endometrial or breast cancer and pancreatic cancer.     Participants with Human Epidermal Growth Factor Receptor 2 (HER2)/neu negative breast cancer     will receive RO5509554 in combination with paclitaxel. Anticipated time on study treatment is     until disease progression, unacceptable toxicity, death or participant refusal, whichever     occurs first.   "
136757|NCT01494675|"     Recently, biomarkers like procalcitonin have been studied in order to help physicians to     decrease the duration of the antibiotic therapy. The investigators objective was to assess     whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy     in critically ill patients with a proven infection without risking a worse outcome.   "
136758|NCT01494662|"     The purpose of this research study is to determine how well neratinib works in treating     breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that     may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a     family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).      In this research study, the investigators are looking to see how well neratinib works to     decrease the size of or stabilize breast cancer that has spread to the brain. The     investigators are also looking at how previous treatments have affected your thinking (or     cognition) and how much neratinib reaches the central nervous system.   "
136759|NCT01494649|"     A pilot study to determine the ability of a stannous fluoride containing toothpaste to     provide immediate and short term relief from dentine Hypersensitivity compared to a control     toothpaste.   "
136760|NCT01494636|"     This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The     study is split into two parts. Part A will assess the safety and tolerability of the new     drug. Part B will assess safety and tolerability as well as the effect of GSK2339345 on     induced cough.   "
136770|NCT01494506|"     The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil     (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic     pancreatic cancer patients who have progressed on prior gemcitabine based therapy.   "
136771|NCT01494493|"     The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone     dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease.   "
136835|NCT01493778|"     This trial is conducted in Asia, Europe and North America. The purpose of the trial is to     evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in     previously untreated children with haemophilia A.   "
136761|NCT01494623|"     Deficits in working memory (WM) performance are the most significant cognitive impairments in     schizophrenia (SCZ). It has also been shown that WM performance is contingent on the cortex     synchronization, a process that relies on brain inhibition. Repetitive Transcranial Magnetic     Stimulation (rTMS) has been demonstrated as an effective treatment for patients with SCZ and     has been shown to increase brain inhibition and improve cognitive performance. In this study     the investigators intend to:        -  evaluate rTMS as a treatment for WM deficits in SCZ        -  evaluate rTMS as a method to increase WM performance in healthy individuals        -  determine if improvements in WM performance are related to enhanced synchronization of          brain networks        -  determine whether genetic polymorphisms predict cortical function and treatment response        -  evaluate the influence of rTMS treatment on brain structure.   "
136777|NCT01494415|"     Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based     paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer,     especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and     concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel,     carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung     cancer may have promising result.   "
136778|NCT01494402|"     The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered     ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK)     of D961S, esomeprazole and buffered ASA following repeated administration in healthy male     Japanese subjects.   "
136854|NCT01493531|"     This study will compare the serum uric acid lowering effects, clinical benefits, and safety     of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who     have had an inadequate response to allopurinol.   "
136762|NCT01494610|"     This is a comparative bioavailability study to compare the pharmacokinetics and     pharmacodynamic effects of Fluticasone propionate and Salmeterol delivered in a capsule-based     inhaler versus a multi-dose dry powder inhaler in patients with moderate asthma and in     patients with moderate to severe Chronic obstructive pulmonary disease (COPD).      Co-primary endpoints will be the area under the curve (AUCτ) measured for plasma Fluticasone     propionate (pharmacokinetic) and the pharmacodynamic effects of Fluticasone propionate     (weighted mean serum cortisol over 0-12h) on the last day of each 10 day study treatment     period. Secondary endpoints will include the following pharmacokinetic parameters for both     fluticasone propionate and salmeterol: AUClast, AUC(0-t), Cmax, Cmin, tmax, λz, and t1/2 as     well as the pharmacodynamic effects of salmeterol (pulse rate, blood pressure,     electrocardiogram [ECG], potassium and glucose) and Fluticasone propionate (urine cortisol     levels). Safety (adverse events and laboratory abnormalities) will also be assessed as a     secondary endpoint.      The study is a randomised, double blind, double dummy, four-period cross-over study.     Approximately 60 asthma or COPD patients will be randomised. Patients meeting eligibility     criteria will receive Fluticasone propionate/salmeterol 250/50mcg bid, from a capsule-based     inhaler and from a multi-dose dry powder inhaler for a period of 10 days each in a randomised     order. All patients will receive treatment from each device twice. To maintain the double     blind, each patient will receive active treatment and placebo at the same time from two     separate devices.   "
136763|NCT01494597|"     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the     pharmacokinetics of cyclosporine in healthy adult subjects.   "
136764|NCT01494584|"     This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of     ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled     partial onset seizures or Lennos-Gastaut syndrome.   "
136765|NCT01494571|"     The PharmaJet needle-free injection system is a consistent approach to delivering injectates     into the dermal layer of the human skin for the purpose of vaccination or medication     delivery.   "
136766|NCT01494558|"     Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard     of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents     used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in     conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III     trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen     over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide     and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB).     It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive     conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The     chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and     36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over     30min weekly). The primary purpose is to evaluate objective response rate, complications,     progression-free survival, overall survival. The second purpose is to evaluate quality of     life and cost.   "
136767|NCT01494545|"     The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time     contact lens wearers.   "
136768|NCT01494532|"     This is a double blind, fixed dose, parallel group study to characterize the dose response of     ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's     disease. The primary endpoint of this study, mean change from baseline in total awake time     spent off' is the same endpoint as used in the ropinirole PR pivotal study for advanced     Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg)     with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total     awake time spent off compared with placebo. The dose of Ldopa will remain stable through     the study, unless the subject experiences tolerability issues that require an L-dopa dose     reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to     approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid     confounding the efficacy data. Clinical review of the primary and secondary endpoints will be     performed in order to establish the lowest maximally effective therapeutic dose.   "
136769|NCT01494519|"     The purpose of this study is to compare the use of modern ring external fixation versus     internal fixation for fracture stabilization of severe open tibia fractures.   "
142135|NCT01424033|"     The first objective of this protocol is to assess the tolerability and safety of     N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung     disease (CTD-ILD).   "
136772|NCT01494480|"     Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis     due to the continued loss of motoneurons that leads them to death in less than 5 years. No     treatment has changed its natural history. Intrathecal injection of umbilical cord     mesenchymal stem cells can secret trophic factors that keep the motorneurons functional. The     investigators have designed a phase I/II clinical trial to check the feasibility of this     approach in humans.   "
136773|NCT01494467|"     The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its     vehicle when applied once daily, at bed time, during a 12 week period in subjects with     Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.   "
136774|NCT01494454|"     This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal     System in treatment of the patients with degenerative disc disease.   "
136775|NCT01494441|"     The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and     rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to     instrumented fusion with autograft in patients with symptomatic degenerative disc disease.   "
136776|NCT01494428|"     The purpose of this pilot clinical trial is to evaluate the device design as a method of     facilitating spinal fusion.   "
136855|NCT01493518|"     The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557     following multiple subcutaneous dose administration in adults with moderate to severe     psoriasis.   "
136779|NCT01494389|"     The purpose of this study is to explore the value of CD4+T lymphocyte subsets in cell     immunity in the patients with sepsis.There are immunoparalysis in septic patients,the     important player is the change of CD4+T lymphocyte,this immunoparalysis state contribute to     the illness progress and outcome. Comprehend the change regularity of septic patients' cell     immunity can guide fiter and correcter treatment.   "
136780|NCT01493323|"     Suicidal behaviour (SB) represents a major public health problem, costing life in more that     one million people every year worldwide. Even if SB is considered as a consequence of social     adversity and depression, these stress factors are often necessary but not sufficient to     explain the occurrence of a suicidal act. A preliminary study suggests that an increased     perception of psychic pain during a major depressive disorder increases the risk of suicide     behaviour. The investigators aimed to investigate the relationship between social exclusion     (a classic trigger of psychic pain) and SB and improve our knowledge about the     physiopathology of this domain.   "
136781|NCT01493310|"     This trial will find the best dose of mifepristone when given together with nab-paclitaxel     (Abraxane) based on the side effects of the two drugs in patients with advanced breast     cancer.      Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the     first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel with     mifepristone until their disease worsens or they experience an unacceptable side effect.      This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The     study will first test the lowest dose in a small group of patients and if they do not have     bad side effects, higher doses will be tested.   "
136782|NCT01493297|"     The objective of this study is to investigate the effect of vitamin A and carotenoids on iron     absorption in healthy subjects with low and normal vitamin A status. Vitamin A and     carotenoids have been reported to enhance the nonheme iron absorption, but the results from     human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have     consistently reported an increase in iron absorption, whereas stable and radio isotopes     studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A     status of the subjects may be a possible explanation for the contradictory findings. In this     study, iron absorption will be measured from an iron-fortified maize bread meal with or     without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope     techniques in Venezuelan women with a range of vitamin A status.   "
136783|NCT01493284|"     The purpose of this study is to assess the safety and effectiveness of the SJM Portico     Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in     subjects with severe symptomatic aortic stenosis (AS).   "
136784|NCT01493271|"     This randomized, double-blind, placebo-controlled, multi-center study will evaluate the     safety and the effect of RO5093151 on intraocular pressure in patients with ocular     hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of     RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the     possibility to extend to 28 days.   "
136785|NCT01493258|"     In this project the investigators seek to utilize our experience for developing a     comprehensive informatics framework for rapid adaptation and dissemination of Comparative     Effectiveness Research (CER) products tailored to different categories of health consumers     including difficult-to-reach patients. Based on our previous successful experience in     computer-assisted education, the investigators will refine the current CO-ED platform to     implement and test a novel system for individualized continuous patient education (iCOPE).     The iCOPE platform will be specifically designed to support rapid adaptation, customization,     and dissemination of the CER products to the difficult-to-reach populations. The iCOPE     platform will implement universal means for customized delivery of CER information in the     format of interactive self-paced educational modules, quick question & answer guides, and     interactive decision aids. In addition, the iCOPE platform will support the innovative     concept of continuous patient health education by providing patients with easy access to the     interactive CER updates via web, MP3 players and phone-based interactive voice response (IVR)     technology. Though iCOPE will be designed to support the whole spectrum of CER products, in     this project the investigators will focus on the Comparative Effectiveness Research Summary     Guide (CERSG) entitled Pills for Type 2 Diabetes.      The following primary hypothesis will be tested in the RCT: Use of the iCOPE platform will be     associated with improvement in CERSG knowledge in elderly at 6 months after the intervention.      The investigators will also examine the impact of iCOPE on medication adherence     self-efficacy, diabetes medication satisfaction, HbA1c, and CERSG acceptance.   "
136786|NCT01493245|"     The purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients with     moderate to severe chronic pain who switched from opioid analgesics, as well as the safety     and efficacy of long-term treatment (52 weeks) after switching to JNS020QD.   "
136787|NCT01493232|"     In this randomized clinical trial to compare the patients' satisfaction of complete dentures     with different occlusal forms, after simple randomized sampling of 15 participant that will     be signed informed consent and their latest teeth was extracted 3 month ago, will be     selected. For each participant, it will be made 3 set of complete dentures that are variable     in occlusion only. During the study, dissatisfied participants can leave it. Each set will be     inserted for 1month in 5 participant randomly. The participants will be examined in two     stages, after a day and after a week. At the end of month the questionaire will be filled out     and the pressure under the mandibular denture base will be measured with the pressure     sensors. Then the second and third denture will be inserted simultaneously.   "
136788|NCT01493219|"     The purpose of this study is:        1. To learn if (MMP-2, MMP-9 and NGAL) which are substances found in blood and urine          associated with tumors, can be used as tumor markers in the management and treatment of          glioblastoma.        2. To study the relationship between MMP-2, MMP-9 and NGAL with quality of life and disease          symptoms.   "
136789|NCT01493206|"     The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal     cancer improve outcomes without causing significant side effects.   "
136840|NCT01493713|"     The purpose of this study is to to evaluate the correlation of overall objective response     according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic     response by CT, and histopathologic response in patients with resectable hepatic metastasis     secondary to colorectal cancer treated with bevacizumab in combination with XELOX.   "
136790|NCT01493193|"     It is the aim of the study to compare the effects of 6 weeks of either high-intensity     interval training (HIT; carried out at correctly assessed 85-95% of maximal heart rate),     pyramid, or continuous endurance training, on changes of physical exercise capacity in     cardiac patients.      The three exercise arms (isocaloric) are composed as follows:      Endurance training (n=15): 31min at 65-75% HRmax; HIT (n=15): 4x4min intervals at 85-95%     HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min;     Pyramids (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with     one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85%     HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards     with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75%     HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax,     making it a total of 28min.      All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70%     HRpeak.      Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of     power output in watt at lactate thresholds at 2 and 4 mmol/l.   "
136791|NCT01494363|"     1. Goals           The primary goal of this phase II trial is to:           evaluate the response rate of combination chemotherapy with Fluorouracil, Leucovorin,          Oxaliplatin, and Irinotecan in patients with locally advanced or metastatic Biliary          tract cancer as first-line chemotherapy           Secondary goals are to:           evaluate the treatment-related toxicities of this combination, investigate          progression-free survival(PFS) and overall survival(OS) in this population        2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase          II trial according to the two stage testing design by Simon two-stage testing procedure   "
136792|NCT01494350|"     The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an     open-label single site trial designed to expand our safety database and capture additional     efficacy (final clinical cure rate of an index lesion) of WR 279,396 Topical Cream in     Tunisian subjects with non-complicated, non-severe Cutaneous Leishmaniasis (CL). Subjects     will be patients who visit Ministry of Health sponsored clinics in Tunisia who present with     at least one CL lesion that is ulcerated and amenable to topical treatment. Potential trial     subjects will be consented and screened for eligibility including medical history, physical     exam, lesion parasitology, and renal and liver function tests. If eligible for the study,     subjects will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n     = 110). The cream will be applied topically to all CL lesions once daily for 20 days by an     investigator or study nurse. If a subject develops a new lesion during the study, the new     lesion may also be treated with the topical cream.   "
136793|NCT01494337|"     The investigators are now proposing to compare two laser techniques for treating Benign     prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus     (greenlight) XPS which is a recently available technology in our center and is more efficient     hence our choice to include patients with any size prostate. This will confirm whether the     two techniques are equivalent in efficacy and safety independent of size as well as cost. The     two techniques are available world wide as standard of care   "
136794|NCT01494324|"     The purpose of this study is to see if the investigators can do some tests on tissue from the     area of the ablation. The investigators want to know if a test can help predict whether the     ablation worked.      The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in     the area treated by ablation. However, cancer cells may begin to grow in or near the treated     area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy     liver cells that just look different because of the ablation. The test the investigators will     study should be able to tell us the difference.   "
136795|NCT01494311|"     Arterial catheterization is painful and is associated with patient stress and anxiety.     Analgesia is usually provided by subcutaneous injection of local anesthetic. An alternative     is topical anaesthesia, such as Rapydan which is a novel topical anesthetic patch containing     70 mg each of lidocaine and tetracaine. We therefore tested the hypothesis that Rapydan patch     analgesia is non-inferior to subcutaneous local anesthetic.   "
136803|NCT01494207|"     The main aim of this study is to measure the effectiveness of a worksite health promotion     programme on improving physical activity behaviour and associated biological risk factors for     cardiovascular disease among South African employees at increased risk for cardiovascular     diseases. Additionally, the investigators will conduct an economic evaluation to determine     the associated cost- effectiveness of these health related interventions offered at South     African companies.      The investigators hypothesize that employees who receive the intervention counseling will     have increased levels of physical activity and reduced risk for cardiovascular disease     compared to those in the control group.   "
136796|NCT01494298|"     Compared to other races, African-Americans with type 2 diabetes have different cholesterol     levels, specifically triglycerides and low density lipoprotein. Recent data has shown the not     only are cholesterol levels important in determining the risk for cardiovascular disease, but     the size of the cholesterol particles and surface proteins on the cholesterol particles are     also important. The objective of this study is to determine if African-American males with     diabetes have different particle size, surface proteins, and cholesterol genetic links than     African-American male without diabetes and Caucasian-American males with and without     diabetes.      African-American males with type 2 diabetes and not taking lipid-lowering medications are the     current target population.      After obtaining an informed consent, a complete medical history will be obtained and subjects     will be examined, noninvasively, for physical signs of elevated cholesterol levels.     Afterwards, blood samples [one venous puncture, 6 tubes (21 mL total)] will be obtained.     Blood samples will be coded, sent to Berkeley Heart Lab and/or Clinical Laboratory Services,     and undergo genetic testing at Mercer University College of Pharmacy and Health Sciences.      Confidentiality of the subjects will be explained in the consenting process to the subjects.     All subject samples and information will be coded. Each subject will be given a subject     number upon consenting and this will be used throughout the study. All pertinent information     of the subjects will be listed under the designated number, but will not be associated with     that patient.   "
136797|NCT01494285|"     This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group,     ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with     mild to moderate acne vulgaris.   "
136818|NCT01493999|"     MAIN AIM: To compare the pharmacological potency of administering adjusted 600 mg clopidogrel     loading doses and 60 mg prasugrel in patients with high on-clopidogrel platelet reactivity     (HPR) after PCI.      SECONDARY OBJECTIVES: To define the optimal maintenance dose with both prasugrel (5 mg vs. 10     mg) and clopidogrel (75 mg vs. 150 mg) in patients with HPR for chronic therapy.      DESIGN: Prospective, Randomized, Open-label, Single-center trial.      PRIMARY ENDPOINT: Platelet reactivity measured with Multiplate between clopidogrel and     prasugrel arm at day 4.   "
136798|NCT01494272|"     Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It     has been shown to be effective in managing postoperative pain in children undergoing     abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown     that children receiving caudal blocks have secondary benefits such as lower narcotic and     anesthetic requirements, more rapid awakening from general anesthesia, decreased time to     discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias     et al 1995, Tobias 1996).      This proposed study involves the use of a caudal block in children undergoing elective     inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in     pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a     caudal block before the onset of a painful stimulus, we can decrease central nervous system     sensitization and reduce postoperative analgesic requirements   "
136799|NCT01494259|"     This double-blind, randomized, controlled clinical trial comparing patient-reported pain and     pain medication/narcotic use between patients randomized to treatment (bupivacaine) or     placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have chosen     to have a mastectomy on one side immediately followed with tissue expander placement breast     reconstruction.      Patients will be randomized 1:1 to bupivacaine- (treatment) or saline-(placebo) filled     percutaneously-placed pain pumps; neither the participants nor the study staff will know     participants' treatment. Data on patient-perceived pain and pain medication use will be     collected before surgery, during surgery, and after surgery on Days 1, 2, 3, 7, and 90, and     at Years 2 and 4 by phone.      The investigators hypothesize that patients randomized to the treatment (bupivacaine) group     will have significantly lower pain scores and use less pain medicine than patients who     receive placebo during the first 90 days following their surgery. The Year 2 and Year 4     follow-ups are included as tertiary endpoints to capture differences in chronic pain, and     patients will be asked to complete the same questionnaires as at the Day 90 follow up.   "
136800|NCT01494246|"     Objectives. To evaluate the effectiveness and cost effectiveness of clinical practice guide     based intervention with two face-to-face visits and e-mail tracking compared to brief advice     to obtain continued smoking abstinence at 6 and 12 months after intervention.      Methodology. simple randomized controlled multicentric trial. All smokers (N=1064) aged 18 or     older that attend by any reason to the primary care center and that have an e-mail account     and they checked it at least once a week will be invited to participate. The enrolled     participants will be randomly divided into control (N=532) and intervention group (N=532). An     intensive intervention, based on the recommendations of the clinical practice guides, that     will include six contacts (2 face-to-face and 4 by e-mail) will be applied to the     intervention group. Control group will receive brief advice.      The main dependent variable will be continued abstinence of tobacco consumption at six and     twelve months after the beginning of the intervention which will be validated by and a carbon     monoxide breathe analysis measured by a cooximeter in standard conditions. Secondary     variables will include: stage change on the quitting smoking process and evaluation of the     effectiveness on the reduction of the number of smoked cigarettes at six and twelve months     after intervention. A descriptive analysis of all variables will be done. A multivariate     analysis will be undertaken to assess differences among intervention and control group;     logistic regression for dichotomic variables and lineal regression for continuous variables.   "
136801|NCT01494233|"     The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of     dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).   "
136802|NCT01494220|"     Bispectral index (BIS) monitoring during living donor liver transplantation (LDLT) may be     influenced with several factors rather than the depth of anesthesia such as bradycardia,     hypotension, hypothermia, and mixed venous oxygen saturation (SvO2). The investigators tested     the validity and the independent factors which may alter of BIS readings during LDLT.      Up to the investigators best knowledge, the independent predictors for BIS monitoring were     not identified yet during the three phases of liver transplantation.   "
137164|NCT01489345|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-2952     across ascending multiple doses in healthy adult male and female subjects. The secondary     objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.   "
136804|NCT01494194|"     Air Structuring Protein (ASP) is a small protein derived from a fungus which is already     widely used to produce enzymes that are added to foods. ASP has the possibility of     stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential     ice-cream ingredient.      Toxicological tests have also been carried out to further confirm the safety of the material     and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.      As part of the safety evaluation of a new protein for use in foods, the potential     allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect     of ASP. This study will investigate:        -  Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population          of participants with proven sensitivity to mould.        -  Whether ASP is responsible for any positive SPT reactions, should they occur.        -  And if any positive SPT reactions to ASP occur, whether such reactions are clinically          relevant with respect to food allergy.      The study is divided in three stages. In Stage 1 and Stage 2, the SPT is open label, which     means that both the participant and the study doctor will know which materials are being     tested.      In Stage 3, the food challenge has a crossover design, meaning that participants will take     one of the products (ASP or placebo [food containing no ASP]) during the first half of the     study and the other treatment during the second half. The order of ASP and placebo will be     decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair     as possible, the food challenge is double blinded. This means that neither the participant     nor the study doctor will know which kind of products (ASP or placebo) the participant is     taking.      This is a multi centre study which is taking place in the UK.   "
136805|NCT01494181|"     Plan of investigation:      This is an observational cohort study to determine the effect of OSA, independent of other     risk factors, on postoperative vascular events. The study is conceived, designed and will be     conducted, and analyzed independent to any company. There is no commercial sponsorship.   "
136828|NCT01493869|"     The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75     mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another     objective is to assess the safety and tolerability of cabozantinib in these adult subjects.   "
136829|NCT01493856|"     The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of     combination of rosuvastatin and CS-866 and DWJ1276 alone.   "
136806|NCT01494168|"     Introduction:      Obesity is a major public health problem, associated with many morbidities, including     metabolic and cardiovascular disease (CVD). High blood pressure (hypertension) is the most     common comorbidity and one of the major risk factors for CVD and kidney failure. It has been     described an almost linear relationship between body mass index (BMI) and the level of blood     pressure (BP), but the mechanisms underlying this relationship are complex and incompletely     understood : activation of renin-angiotensin-aldosterone and sympathetic nervous systems,     alterations in systemic hemodynamics and arterial parameters; a significant correlation     between overall and / or visceral obesity and arterial stiffness assessed by carotid-femoral     pulse wave velocity (PWV) has been observed.      By its effectiveness in terms of magnitude and sustainability of weight loss, bariatric     surgery is becoming increasingly important in the management of obesity and the prevention of     its comorbidities. It reduces all-cause as well as CV mortality. Bariatric surgery allows a     resolution of the metabolic syndrome (in 2 out of 3 patients) and diabetes (in 5 out of 6     patients), but its effect on blood pressure remains inconstant and transient. The reasons for     this limitation and the detailed effects of bariatric surgery on hemodynamics and arterial     parameters have been poorly studied. Of note, a reduction in left ventricular hypertrophy, an     improvement in diastolic dysfunction and aortic distensibility assessed by ultrasound or MRI     have been observed.   "
136807|NCT01494155|"     A standard treatment for patients with pancreatic cancer is standard photon radiation in     combination with the chemotherapy drug, capecitabine. In this research study the     investigators are using standard photon radiation or a different type of radiation therapy     called proton beam radiation and adding hydroxychloroquine to be used in combination with     capecitabine.      In this research study, the investigators are looking to determine if proton or photon beam     radiation in combination with hydroxychloroquine and capecitabine is effective in controlling     your cancer growth.   "
136808|NCT01494142|"     The purpose of this multi-center, clinical registry study is to determine genetic markers     associated with susceptibility of AD patients to infections and to also serve as a potential     participant database for future studies.   "
136809|NCT01494116|"     The purpose of this study is to determine the impact of syringe size on the amount of time it     takes a health care provider to administer a known volume (900 mL) of resuscitation fluid to     a non-clinical, toddler-sized, model. The investigators hypothesize that syringe size will     impact fluid resuscitation time.   "
136810|NCT01494103|"     Patients will be receiving a stem cell transplant as treatment for their disease. As part of     the stem cell transplant, patients will be given very strong doses of chemotherapy, which     will kill all their existing stem cells.      A close relative of the patient will be identified, whose stem cells are not a perfect match     for the patient's, but can be used. This type of transplant is called allogeneic, meaning     that the cells are from a donor. With this type of donor who is not a perfect match, there is     typically an increased risk of developing GvHD, and a longer delay in the recovery of the     immune system. Seventy to ninety percent of people who receive unchanged marrow or stem cells     from this type of donor will develop severe GvHD.      GvHD is a serious and sometimes fatal side-effect of stem cell transplant. GvHD occurs when     the new donor cells (graft) recognize that the body tissues of the patient (host) are     different from those of the donor. When this happens, cells in the graft may attack the host     organs, primarily the skin, liver and intestines, causing severe rashes, diarrhea, liver     disease, and even death. GvHD is caused by a type of immune cell in the graft called T cells.      While this stem cell selection procedure will reduce the risk of GvHD, it will also result in     slower recovery of the patient's immune system. As the immune system is responsible for     fighting infections in your body, a longer recovery time after a transplant means that the     patient may be at increased risk for infections which can become life-threatening. In some     patients, the immune system can also fight leukemia cells and reduce the risk of relapse.      In this study, investigators are trying to see whether they can make special T cells in the     laboratory that can be given to the patient to help their immune system recover faster. As a     safety measure, we want to program the T cells so that if, after they have been given to     the patient, they start to cause GvHD, we can destroy them (suicide gene).      Investigators will obtain T cells from a donor, culture them in the laboratory, and then     introduce the suicide gene which makes the cells sensitive to a specific drug called     AP1903. If the specially modified T cells begin to cause GvHD, the investigators can kill the     cells by administering AP1903 to the patient. We have had encouraging results in a previous     study regarding the effective elimination of T cells causing GvHD in vitro, whilst sparing a     sufficient number of T cells to fight infection and potentially cancer.      More specifically, T cells made to carry a gene called iCasp9 can be killed when they     encounter the drug AP1903. To get the iCasp9 gene into T cells, we insert it using a virus     called a retrovirus that has been made for this study. The drug (AP1903) that will be used to     activate the iCasp9 is an experimental drug that has been tested in a study in normal     donors with no bad side-effects. We hope we can use this drug to kill the T cells. Other     drugs that kill or damage T cells have helped GvHD in many studies, but with a more profound     reduction of immune defense. However, if the patient develops significant GvHD, they will     also receive standard therapy for this complication, in addition to the experimental drug.      The major purpose of this study is to find a safe and effective dose of iCasp9 T cells that     can be given to patients who receive an allogeneic stem cell transplant. Another important     purpose of this study is to find out whether these special T cells can help the patient's     immune system recover faster after the transplant than they would have otherwise.   "
136811|NCT01494090|"     Statins (or HMG-CoA reductase inhibitors) have largely proven their efficacy in the primary     and secondary prevention of cardiovascular events. Many clinical and experimental studies     support also a potential beneficial effect of statin therapy on venous thromboembolism (VTE).     Patients with hip fracture are at high risk of VTE and cardiovascular events.      The aim of this study is to evaluate the efficacy and the tolerance of a statin     (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic     events and the global mortality at six months.      Subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the upper     portion of the femur (hip fracture) are eligible to participate to this multicentre,     randomized, double-blind placebo controlled trial. They will receive either rosuvastatin (5     or 20 mg) or placebo for 6 months. The primary efficacy outcome is the incidence of an     adjudicated composite of non fatal VTE, acute coronary syndrome, non fatal stroke, other     acute ischemic arterial event, or all-cause death.      Assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients     will be required for the study to have 80% power to detect a 30% reduction in the relative     risk with rosuvastatin (with a two-sided alpha level of 5%).      The investigators assumed that rosuvastatin could have a positive benefit-risk ratio in     patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and     global mortality at six months.   "
136812|NCT01494077|"     The purpose of this research project is to determine if pancreatic cyst fluid can be diluted     and provide an accurate Carcinoembryonic Antigen (CEA) level. The investigators hypothesis is     that pancreatic cyst fluid obtained by EUS-FNA can be diluted effectively and accurately for     the measurement of CEA levels.   "
136813|NCT01494064|"     This study seeks to assess the impact of the standardization of nursing supervision of     patients with hepatic encephalopathy using a grid of appropriate surveillance for the     prevention of complications in the ICU.   "
136814|NCT01494051|"     The study also determines if eating a diet higher in protein alters body composition, energy     balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.   "
136816|NCT01494025|"     Elevated fat levels within skeletal muscle cells (intramyocellular lipids) are highly     correlated with muscle and whole-body insulin resistance, and more prevalent in obesity. The     molecular links and metabolic shifts driving this association remain open to debate, but     notably, reduced muscle mitochondrial fatty acid (FA) ß-oxidation is more prevalent among     insulin-resistant/diabetic persons. Therefore, discovery of biomarkers reflective of the     status of an individual's muscle FA ß-oxidation activity or capacity would have tremendous     prognostic and diagnostic value in terms of diabetes. Furthermore, characterization of     metabolites associated with muscle mitochondrial fat metabolism should uncover candidate     signaling factors which tie FA ß-oxidation to insulin signaling. The investigators propose to     identify, for the first time, specific biomarkers of muscle FA ß-oxidation using multiple     metabolomic analytical platforms to compare metabolite profiles in samples derived from     biological systems displaying disparate muscle fat combustion. The current experiment will     test whether plasma metabolites and/or metabolite signatures that track efficient muscular FA     ß-oxidation can be experimentally increased in obese, insulin-resistant subjects via a     diet-exercise regimen designed to improve muscle fitness and FA combustion.   "
136817|NCT01494012|"     This phase I trial studies the side effects and the best dose of stereotactic body radiation     therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary     peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less     damage to normal tissue.   "
136819|NCT01493986|"     Systemic LA toxicity is an important complication of regional anesthesia. Lowering the LA     dose is one of the strategies to reduce this risk. For upper limb blocks it is well     documented that ultrasound guidance allows a significant lower dose of LA for interscalene     and axillary blocks than with guidance by peripheral nerve stimulation. However, a     corresponding difference has not yet been found for supraclavicular and infraclavicular     blocks. The aim of the present study is to define the minimum effective volume of ropivacaine     7.5 mg/ml when using the LSIB method.   "
136820|NCT01493973|"     Friedreich's ataxia (FRDA) is a rare genetic disorder characterised by severe neurological     disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency.     Although several drugs have been proposed, there is no available treatment. Four trials     recently demonstrated that erythropoietin can increase the intracellular levels of frataxin.     The present project is aimed at testing a long term therapeutic approach using     erythropoietin, which is an already available and commercialised drug. The study will test     the effect of erythropoietin on exercise capacity, which is reduced in patients with FRDA.     Additional objectives of the study will be the drug's safety and tolerability, and its effect     on frataxin, blood vessel reactivity, heart functional indexes, and disease progression.   "
136821|NCT01493960|"     The purpose of this study is to determine if Kappaproct is effective in the treatment of     chronic active ulcerative colitis patients not responding to available therapy.   "
136822|NCT01493947|"     Study objectives:        -  To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream          in subjects with papulopustular rosacea after 16-week topical treatment.        -  And to compare, for subjects initially successfully treated by 16 weeks treatment,          Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period          by assessing, the time of first relapse, the relapse rate, and the number of days free          of treatment   "
136823|NCT01493934|"     Insulin resistance, characterised by a depressed cellular sensitivity to insulin in     insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no     diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality,     whatever the cause, but, as a majority, cardiovascular diseases.      In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an     increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led     to grow in a near future, because of the increase of diabetes mellitus and obesity     prevalence.      Actually, there is no simple tool to measure insulin resistance. The gold standard technique     remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this     technique render it unsuitable for routine clinical use. Many methods or index have been     proposed to assess insulin resistance in human, but none have shown enough relevance to be     used in clinical use.      Within the investigators U877 INSERM team, the investigators previously performed in vivo     biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose     transport, radiolabelled with123 iodine, with and without insulin, on the one hand in     genetically diabetic mice (db/db), consequently having a severe insulin resistance and in the     other hand in rats with acquired insulin resistance after a fructose diet.      The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose     transport variations in insulin sensible organs. Then, the investigators developed a fast and     simple imaging protocol with a small animal gamma camera, which allows the obtaining of an     insulin resistance index for each organ, directly transferable to human.      The investigators project is to transfer to human this measurement technique, perfectly     validated in animal.      The main goal of this monocentric phase I-II study is to evaluate the tolerance to the     insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and in     diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2 diabetic     patients.      The investigators secondary goals will be to evaluate feasibility and reproducibility of the     measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure     insulin resistance.   "
136824|NCT01493921|"     Studies of SR-T100 gel and its clinical relevance in the treatment of AK, providing adequate     measured outcomes for skin lesion treatment. In addition to the high complete response rate     (90.0%) as compared with the conventional therapy, the most significant result was that no     undesirable side effects were associated with the use of SR-T100 gel. The result also shows     approximately 80% of study subjects had a complete response in phase II clinical trial     conducted in Taiwan; hence, result from our study model suggested SR-T100 gel offers     beneficial therapeutic values in treatment of AK is harmless to the skin as well as high     tolerance level displayed by majority of patients.   "
136836|NCT01493765|"     The goal of this project is to improve the efficiency of training and assessment of technical     skill in surgical treatment of otologic disease. Through previous funding, we have developed     an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal     bone surgery. Using direct-volume visualization techniques with integrated stereoscopic     display, haptic (force) feedback, and aural simulation, we have achieved a straightforward,     low-cost learning environment ready for translation into a practical training and assessment     tool. This application challenges and seeks to shift current practice in clinical training by     translating the simulation environment into a vehicle for curriculum development, technical     skills assessment, and dissemination. The intent is to provide more accessible, inexpensive,     safe, and deliberate practice with objective and continuous quantitative, objective     assessment in the early stages of training.   "
137080|NCT01490450|"     The purpose of this study is to characterize the safety, efficacy and dose response of     BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to     Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying     anti-rheumatic drugs (DMARDs).   "
136825|NCT01493908|"     The efficacy of the placebo effect has been proved in many prior studies by comparing the     symptoms and measures of patients. Placebo has been proved to help in treating illnesses such     as depression, stomach ulcer and chronic headaches.      A Meta analysis checked 47 studies about placebo and showed great significance when a patient     is treated with placebo pill, no active substance, just by activating conditioning and     expectation mechanism in his body, thus providing to the healing process, and that is it's     importance.      In recent years studies established a relationship between marketing variables (such as     price, label) to the efficacy of a product. In addition- a unique research run in 2008 showed     a significant relationship between the marketing strategies and the efficacy of medication;     more specifically, patients in this research experienced less (controlled) pain when treated     with placebo medication introduced to them as more expensive than patients treated with     placebo medication that was introduced to them as much cheaper. All patients were treated     with the exact same medication.      In the investigator's experiment the investigators design a laboratory experiment to     determine if marketing factors could invoke the placebo effects described earlier. For the     initial laboratory experiment, we decided to examine the difference in price, on the efficacy     of an OTC analgesic through the mediation of low- voltage electrical pulses to the patient's     wrist.      The investigators study hypothesis is that marketing variables such as price and brand name     will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater     influence when the patient is aware of its price compared to one who is not.   "
136826|NCT01493895|"     For centuries, light has been a well-known and effective healing method. In the beginning of     the 20th century there was a first attempt to condense light energy and distribute it in     higher levels, a use that was successfully applied on many soldiers wounded in the Second     World War. The laser, which is based on the quantum phenomenon of stimulated emission, was     first demonstrated in the beginning of the 1960s and immediately received many applications     in all areas of medicine.Many different studies were carried out in the past decade trying to     assess the effect of laser therapy on properties of healing wounds. This study aim to assess     the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing     diabetic foot ulcers.   "
136827|NCT01493882|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of     JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current     treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (LABA) and/or     montelukast for at least 4 weeks.   "
136830|NCT01493843|"     This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the     efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and     without pictilisib in particpants with previously untreated advanced or recurrent non-small     cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin     (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous     NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on     study treatment is until disease progression or intolerable toxicity occurs. Participants in     placebo arms with disease progression may cross over to open-label active pictilisib.   "
136831|NCT01493830|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with     neuroblastoma.   "
136832|NCT01493817|"     This research study is studying biomarkers in tissue samples from younger patients with Wilms     tumor. Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. It may also help doctors     predict how patients respond to treatment   "
136833|NCT01493804|"     Background:      - Different regions of the brain are activated when a person performs a task.     Electroencephalograms (EEGs) and near-infrared spectroscopy (NIRS) are tests that detect     changes in the brain. EEG looks at changes in electrical signals, and NIRS looks at changes     in blood flow. These tests can detect local changes in brain activity in a safe and     noninvasive way. Researchers want to study brain activity more closely by combining these     tests.      Objectives:      - To use EEG and NIRS to study brain activity during specific tasks.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have between one and five testing sessions. Each session will be 1 to          2 hours long. The tests given at each session will be determined by the researchers.        -  Participants will have EEG and NIRS tests, given either separately or together. During          these tests, participants will perform tasks of thinking and reasoning.        -  Participants may also complete optional tests of thinking and reasoning. These tests          will be given on paper or on a computer.   "
136834|NCT01493791|"     Background:      - CDB-2914 is a hormone that blocks progesterone, which is necessary for maintaining     pregnancy. In women with fibroid tumors, CDB-2914 shrank the tumors. In many cases, menstrual     periods stopped during treatment. Because CDB-2914 decreased or stopped menstrual bleeding in     women with fibroids, it may be able to treat abnormal periods in women without fibroids.      Objectives:      - To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women.      Eligibility:      - Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests. An ultrasound with fluid of the uterus will test for          fibroids. Uterine cells will be collected for biopsy.        -  For the next three menstrual cycles, participants will take either CDB-2914 or a          placebo. Treatment will be studied with blood tests and symptom diaries.        -  At the end of the treatment, participants have three options. They can have surgery at          the Clinical Center or have another 3 months of CDB-2914. The third option is to stop          treatment at the Clinical Center.        -  Surgery will be either uterine ablation or hysterectomy. Only women older than age 33          may have a hysterectomy. Blood and urine samples will be collected after surgery.        -  Both surgery and further treatment participants will have followup exams.        -  All participants will have a final followup exam 1 year after stopping treatment.   "
142136|NCT01424020|"     The purpose of this study is to test and validate a new questionnaire in order to get a     walking estimated limitation calculated by history (WELCH) in patients referred for vascular     investigations.   "
136837|NCT01493752|"     Diets rich in fruit and vegetables reduce the risk of strokes and heart attacks, however the     exact cause of this beneficial effect is uncertain. Evidence suggests that certain     vegetables, including beetroot and the green leafy vegetables, possess high inorganic nitrate     concentrations. The investigators recent evidence suggests that inorganic nitrate provides a     source of gas called nitric oxide in the body that exerts a number of beneficial effects upon     the heart and blood vessels . The investigators have previously shown that beetroot juice     ingestion improves blood vessel (vascular endothelial) and platelet function in healthy     volunteers. Studies by the investigators show that these effects are due to conversion of     nitrate to nitrite by symbiotic (helpful) bacteria (located on the tongue) and subsequent     conversion of nitrite to nitric oxide in blood vessels. The investigators now wish to explore     whether dietary nitrate, via its beneficial effects on platelets and blood vessels, might     improve indices of atherosclerotic disease progression in high risk individuals     (hypercholesterolemics). Recruits will have high cholesterol and no known atherosclerosis and     will not yet be on any anti-cholesterol medications. Volunteers will consume a daily dose of     beetroot juice or placebo nitrate-free juice for six weeks. Vascular function will be     assessed using non-invasive techniques at the beginning and at the end of the study using     ultrasound measurement of flow mediated dilatation (FMD) of the brachial artery in the arm     and pulse wave analysis (PWA) and pulse wave velocity (PWV) to measure arterial compliance.     To assess impact on platelet function, blood samples will also be taken at the start and at     the end of the study.   "
136844|NCT01493661|"     Sleep is a physiological state considered essential for health and human survival. The     prevalence of chronic sleep restriction has increased in modern society, as well as the     effects of the same health concerns about various aspects, including the physiological and     neurobehavioral. The objective of this study is to identify the neurobehavioral and     physiological responses of healthy men with different needs of total sleep time (TST)     submitted to chronic sleep restriction. Participants in this study will be 30 male     volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with     TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7     and 8h. The TST will be established by the constant and continuous use of actigraphy for 10     days prior to the onset of the experimental protocol. All volunteers will undergo medical and     polysomnography (PSG) examination to detect the presence or not of changes in sleep as well     as other health problem that prevents their participation in the study. The experimental     protocol consists of a basal night of sleep, five consecutive nights of chronic sleep     restriction to 25% of TST in the beginning night and a night of recovery, which will be     allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in     each day, the volunteer will undergo tests to assess the physiological and neurobehavioral     variables. The significance level will be 5% (p ≤ 0.05).   "
136845|NCT01493648|"     This proposal will explore muscle function (strength and endurance) in men and women     suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle     symptoms will be explored. Also, the investigators will assess the potential usefulness of     vitamin D supplementation in a randomized control trial.   "
136846|NCT01493635|"     The World Health Organization analgesic ladder for cancer pain relief is an internationally     used approach to managing cancer pain. Patients generally start on Step 1 of the ladder     (paracetamol). As pain increases or is not well controlled on this, they progress to Step 2     which involves a stronger pain killer (weak opioid such as codeine). If pain is still not     controlled they progress to Step 3 of the ladder which is a strong opioid (such as morphine).     Work to date has suggested that Step 2 may be unnecessary and most patients usually require     Step 3 analgesia. The TVT trial aims to examine the standard approach (Step 1-Step2-Step-3)     versus a two step approach (Step 1-Step 3).   "
136847|NCT01493622|"     The purpose of this study is to determine whether minocycline are effective in the treatment     of negative and cognitive symptoms in schizophrenia.   "
136848|NCT01493609|"     The CLICK-EAST research project is an investigation of the efficacy of a computer based     learning programme which aims to teach the fundamental components of social attention to     young children with autism spectrum disorder (ASD). Social attention describes the process     of choosing to look at or listen to social information in the world, normally in preference     to any other available information. Social information normally refers to people: for     example, we notice human voices more than birdsong or traffic noise, even if the latter is     louder. As a rule, children with ASD are less likely to prioritise this kind of social     information. This is thought to have a significant effect on their development and behaviour.     For example, a child who doesn't listen to what his parents say may be very slow to learn     language, and may also fail to follow important instructions. Our goal is to create a new     learning programme, in the form of an enjoyable computer game, which encourages children to     practise the skills of looking at and listening to people, despite the presence of     distracting information. The investigators will develop the game with the input of an     advisory group of parents and teachers of children with ASD as well as some young adults with     an ASD diagnosis. Then they will perform a trial of the game with a group of preschoolers     with ASD and their families, in order to determine whether the game is having a positive     effect on the children's abilities.   "
136849|NCT01493596|"     Primary Objective:      • To evaluate the safety and tolerability of ascending single oral doses of CPP-115      Secondary Objective:      • To determine the pharmacokinetic profiles of CPP-115 following administration of a     ascending single oral doses   "
136874|NCT01493128|"     The aim of this work is to study the prevalence of T-tubular system in left and right     myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and     permanent atrial fibrillation. Furthermore, since current information is lacking on the key     Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it     will be investigated whether a regulation of these proteins could be an underlying cause of     the disease. Mitochondrial function will also studied.        1. The investigators hypothesize that both structure of sarcolemma and localization of key          Ca2+-handling proteins are altered in patients with atrial fibrillation compared with          patients in sinus rhythm.        2. The investigators hypothesize that mitochondrial function is altered in patients with          atrial fibrillation compared with patients in sinus rhythm.   "
136850|NCT01493583|"     Recent evidence has pointed to distinct alterations of brain functions in obese subjects some     of which may even be causative for their obesity. The objective of this study was to examine     food and non food related alterations in brain functions after excessive weight loss due to     Roux-en Y gastric bypass surgery (RYGB), one of the most successful therapeutic approaches     for long lasting weight loss. The investigators hypothesized that obese as compared with lean     women show an altered activation pattern in the brain areas involved in the homeostatic     regulation of eating behavior, i.e. the hypothalamus, in reward-related brain areas, such as     the orbital frontal cortex (OFC) and the striatum as well as in prefrontal inhibitory control     areas. Furthermore, the investigators hypothesized that women who had undergone a RYGB     operation show a brain activity pattern that more closely mimics that of lean than severely     obese women. In a supplementary test the investigators will assess gastrointestinal and     metabolic response to a standardized meal in order to elucidate putative correlation of these     responses with the results of fMRI scannings.   "
136851|NCT01493570|"     Due to the exploratory nature of this trial, there is no primary objective in a confirmatory     sense. The study aims      - to evaluate the effect of different doses of BI 409306 on biomarker and to assess the     exposure of BI 409306   "
136852|NCT01493557|"     This is a prospective and open label study that aims to enroll approximately 1200 patients     with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of     gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125     sites in North America will be recruited. Patients who report GIS during the 3 month     treatment period will be randomized to one of two management strategies, and data documenting     the intensity and duration of the GIS will be collected.   "
136853|NCT01493544|"     PUMA is an observational, multicentre, multinational, cross-sectional study with primary care     physicians (primary care, general and family physicians). Participants will be selected     sequentially among patients at risk for Chronic Obstructive Pulmonary Disease (COPD) who     attend primary care consultation (primary care, general and family physicians). The inclusion     visit will be a regularly scheduled or spontaneous consultation for patients, and this     appointment with the physician will not depend on the study. During the appointment, data     will be collected from the patient and the physician.   "
136856|NCT01493505|"     The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination     with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.   "
136857|NCT01493492|"     As a noninvasive examination, urinary proteomics is a very useful tool to identify renal     disease. The purpose of the present study was to find differential proteins among patient     with SIRS and sepsis(included survivors and non-survivors), and to screen potential     biomarkers for the early diagnosis of sepsis and its prognosis. Urinary proteins were     identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with the     Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO) Database     and KEGG pathway Database. The differentially expressed proteins were verified by Western     blot by another sample collected from clinical.   "
136858|NCT01493479|"     90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in     patients who have received previous treatment for lymphoma. More than two-thirds of the     patients who achieve CR go on to experience durable remissions lasting for years. Despite     these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular     lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The     objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in     patients with previously untreated follicular lymphoma in a Phase II study.   "
136859|NCT01493466|"     Serum proteomics is a very useful tool to identify various disease. The purpose of the     present study was to find differential proteins among patient with normal, SIRS, sepsis,     severe sepsis, death and to screen potential biomarkers for their dynamic changes. Serum     proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was     performed with the Mascot software and the International Protein Index (IPI) and the Gene     Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were     verified by Western blot by another sample collected from clinical.   "
136860|NCT01493453|"     In particular circumstances T cells can be an effective treatment for malignant disease, for     example, donor lymphocyte infusions following allogeneic transplants or treatment of EBV     related lymphomas post allograft. However, many common cancers are poorly recognised by the     immune system in part because of a lack of suitable T cell targets and in part because of     defects in antigen presentation by tumours (Garrido, et al 1997). Genetically modified T     cells engineered to express chimeric immune receptors (CIRs) on their cell surface can bypass     the need for MHC presentation and thus represent an attractive approach to immunotherapy     (Gross, et al 1989).   "
136861|NCT01493440|"     Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical     pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro     fertilization and embryo transfer).   "
136862|NCT01493427|"     The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution     without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or     bimatoprost 0.01% ophthalmic solution monotherapy.   "
136863|NCT01493414|"     The primary objective of this study is collect additional safety of INC424 in patients with     Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia     Myelofibrosis, who have either received prior treatment with commercially available agents or     who have never received treatment.   "
136875|NCT01493115|"     Primary Objective:      To compare the pharmacodynamic properties of two different doses of a new insulin glargine     formulation with 0.4 U/kg Lantus®      Secondary Objective:      To compare the pharmacokinetic properties of two different doses of a new insulin glargine     formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin     glargine formulation   "
136876|NCT01493102|"     The purpose of this study is to evaluate the incidence of hypotension based on the     discontinuation order of norepinephrine and vasopressin in patients receiving concomitant     norepinephrine and vasopressin infusions for the treatment of septic shock.   "
142192|NCT01423292|"     The purpose of this study is to determine whether the transversus abdominis plane (TAP)     blocks are effective in postoperative pain control of adult patients undergoing laparoscopic     colectomy.   "
136864|NCT01493401|"     Female urinary incontinence (UI) can be caused by pure stress UI (SUI), pure urgency UI (UUI)     and mixed SUI and UUI (MUI). Clinically it might not be that easy to separate MUI and SUI.     Patients might perceive urgency when they have an incompetent urethra and a full bladder.      Urinary tract nerve growth factor (NGF)is produced by bladder urothelium and smooth muscle.     Increased levels of NGF have been reported in the bladder tissue and urine of patients with     overactive bladder (OAB).      If the urinary levels of NGF differ among women with pure SUI and MUI, then urinary NGF level     might be a biomarker in the differential diagnosis of MUI in women.      Also, decreased urinary NGF level was reported in OAB patients of whom the symptoms were     improved. So, we might expect that the remnant OAB symptom including urgency incontinence can     be improved, if the urinary NGF levels decrease after midurethral slings for SUI in MUI     patients.      We aimed to explore the value of the urinary NGF as a biomarker for differential diagnosis     and as a prognostic marker for predicting the improvement of OAB symptom after midurethral     slings.   "
136865|NCT01493388|"     This study is conducted in Africa. The aim of this study is to estimate the percentage of     children and adolescents below or equal to 15 years in Tunisia with acceptably controlled     diabetes mellitus type 1.   "
136866|NCT01493375|"     In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection     is a very serious condition and despite extensive prophylactic measures, prosthetic     infections appear in 1-2 percent of the operated patients.      It is difficult to diagnose prosthetic infection with the techniques applied so far and     incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections     might lead to prolonged pain and invalidity.      The purpose of this study is to examine the value of these three techniques applied as a     supplement to the existing technology and on this basis to prepare an algorithm for the     examination of joint prosthesis infection.   "
136867|NCT01493362|"     This study will use positron emission tomography imaging to investigate the dopamine systems     in people with bulimia nervosa.   "
136868|NCT01493349|"     Colonic diverticular disease is a highly prevalent condition in Western populations. The     prevalence increases age-dependently from 5% at 40 years to 65% by the age of 85 years (1-3).     The majority remain asymptomatic. However, a significant proportion of the patient population     develops complications, such as diverticulitis with or without symptoms (10-20%) (1, 4-10).     Perforated diverticulitis is rare with an estimated incidence of 4 per 100.000 per year, but     the associated mortality rate is 22% to 39% (9, 11, 12). In the United States, the     complications related to diverticular disease account for 130.000 hospitalizations each year,     resulting in substantial health care costs (13). In Europe, it is estimated that     approximately 23.600 deaths per year can be attributed to complicated diverticular disease,     and the mortality will probably increase in the future due to the aging population (15-17).     Several case studies report an overall increase in the incidence of diverticulitis, based on     the increase in hospitalizations (18). Kang et al, reported a 16% increased male admission     rate and 12% female admission rate for diverticulitis, between 1989/1990 and 1999/2000 (19).     Aging and the Western diet, low in fiber and high in fat, in combination with increased     intraluminal pressure and alterations in colonic motility are considered important     etiological factors. A disturbance in large bowel motility is suggested to be a common     pathophysiological feature in IBS and diverticular disease (20, 21). Based on observations     that IBD, subgroups of IBS and (symptomatic) diverticular disease share clinical symptoms,     the hypothesis is derived that they might also share pathophysiological factors like low     grade inflammation, changed microbiota composition and activity, and increased intestinal     permeability. The identification of clinical and pathophysiological factors associated with     an increased risk for complicated diverticular disease may help to identify patients with     diverticular disease, prevent complications, develop strategies to improve quality of life     and reduce the related health care costs. Therefore we aim to investigate the composition of     luminal and mucosal intestinal microbiota and the intestinal permeability in the development     of diverticular disease and complicated diverticular disease. We hypothesize that both the     intestinal microbiota and intestinal permeability are altered in patients with (current- or     previous history of complicated) diverticular disease.   "
136869|NCT01493336|"     This randomized, open-label, two-way crossover study will evaluate the relative     bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) versus     commercial Xeloda tablets in patients with colorectal or breast cancer. Patients will be     randomized to a sequence of single oral doses of capecitabine RDT or Xeloda on Days 1 and 2     of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.   "
136870|NCT01493180|"     The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for     patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also,     safety of OPC-12759 is to be assessed.   "
136871|NCT01493167|"     The purpose of study is to verify that WOODCAST Circular system performs safely and     effectively in its intended use.   "
136872|NCT01493154|"     This study will test the safety of an HPV DNA vaccine after it is injected into your muscle     using an electroporation device (TriGridTM Delivery System made by Ichor Medical Systems),     and will test the ability of the vaccine to help your body's immune system to recognize     HPV-infected and associated cancer cells. In addition to giving the vaccine using an     electroporation device, we are giving the vaccine in combination with an immunomodulatory     agent to further enhance immune responses against HPV-infected and associated cancer cells.   "
136873|NCT01493141|"     In recent years hip resurfacing has become a very popular alternative treatment to total hip     replacement for the treatment of hip arthritis. This procedure has become particularly common     in the young patient with arthritis because of perceived benefits in terms of functional     outcome. However, it has recently become apparent that hip resurfacing is associated with a     range of adverse events, not typically seen in patients with conventional hip replacement.     These include hip fracture, and failure of bone to grow onto the fixation surfaces of the     implant. It has also become apparent that hip resurfacing results in the release of high     concentrations of dissolved metals in the bloodstream, such as cobalt and chromium. Whilst     small concentrations of these metals are essential for normal body functions, such as making     red blood cells, in high concentrations their effects can be toxic to many cells and organs     of the body, such as bone, the brain, heart, liver and kidneys, as well as disturbing     hormones and blood cholesterol levels. Whilst several studies have documented levels of these     metal ions of 440 times normal levels in hip resurfacing patients, there are no studies that     have examined whether these levels are having a toxic effect on the various organ systems of     the body (with the exception of renal function). In this study we plan to explore whether     there are differences in bone mineral density, accumulation of metal ions in the brain, and     other solid organs, heart and hormonal function between subjects who have had a hip     resurfacing 5 or more years previously compared to an individually matched group of subjects     after conventional hip replacement.   "
137098|NCT01490203|"     The purpose of this study is to determine whether the global and segmental hepatic uptake and     excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver     function test results in the patients with Hepatocellular Carcinoma (HCC) before major     hepatic resection or radiofrequency ablation (RFA).   "
136877|NCT01493089|"     Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied     by acid regurgitation and other symptoms, has a substantial negative impact on a patients'     quality of life. Although a number of treatment options are available, a more effective     therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve     symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to     experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an     earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD     using an immediate-release omeprazole/sodium bicarbonate formulation when compared with     delayed-release omeprazole (Losec®).   "
136878|NCT01493076|"     Precut-sphincterotomy is a well established alternative after repeated futile attempts for     common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly     used devices instruments for pre-cutting are the needle-knife and the Erlangen-type     precut-sphincterotome. In 1996 a so called baby-sphincterotome (Easy-Cut®, MTW, Wesel,     Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip     was developed, which enables cannulation and pre-cutting in one step. Here the investigators     report on the clinical evaluation of this device.   "
136879|NCT01493063|"     The aim of the study is to estimate the impact of the protein content of breastmilk at the     end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.      The investigators expect a difference of at least 5 points of Development Quotient (DQ) when     comparing extreme terciles of the protein content of breastmilk at the end of     hospitalization.   "
136890|NCT01492920|"     This randomized phase III trial studies how well acetyl-L-carnitine hydrochloride works     compared to a placebo in preventing peripheral neuropathy in patients with recurrent ovarian     epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing     chemotherapy. Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral neuropathy     caused by chemotherapy. It is not yet known whether acetyl-L-carnitine hydrochloride is more     effective compared to a placebo in preventing peripheral neuropathy caused by chemotherapy.   "
136880|NCT01493050|"     The purpose of this study is to see if taking a medication can lower the amount of oxidants     from food that go into our body. Previous research shows that if the investigators lower the     oxidants from food in people with diabetes, this simple change lowers different risks for     heart disease and the worsening of kidney disease. The investigators focus on a specific type     of oxidant, advanced glycation endproducts (AGEs). A previous, smaller study, conducted by     our group showed that a drug, already approved by the FDA, will lower AGEs in the     investigators compared Renvela® to Tums®. Both of these drugs have few side effects and have     been used for a long time in patients with diabetes and kidney disease. While our previous     study was interesting, it was just too small to be able to be sure that it will help all     people with diabetes, or if the good effects the investigators found were simply due to     chance. The investigators are doing this new study to confirm or deny the possibility that     Renvela® can really help people with diabetes and kidney disease.   "
136881|NCT01493037|"     A prospective multi-center study in which patients with an acute heart attack (in the left     anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty     followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept     study designed to document the safety and feasibility of the Pressure Controlled Intermittent     Coronary Sinus Occlusion (PICSO) Impulse system.   "
136882|NCT01493024|"     It is hypothesized that zirconium silicate is safe and well tolerated and more effective than     placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum     potassium between 5 - 6.0 mmol/l versus no difference between zirconium silicate and placebo     (null hypothesis). It is hypothesized that zirconium silicate even up to the top dose of 10g     three times a day is well tolerated.   "
136883|NCT01493011|"     Millions of patients die of non-small cell lung cancer (NSCLC) every year. There are several     methods to treat NSCLC, including surgery, chemotherapy, radiotherapy and bioimmuotherapy.     Recently, hyperthermia therapy has played an important role in neoplasm therapy. It has     showed some effect in NSCLC both in animal experiment and clinical practice, yet there is     little literature about Whole-body Hyperthermia (WBH) with neoplasm. The investigators     decides to develop this randomized contrasted multicenter clinical study to testify to the     effect of chemotherapy combined with WBH to treat stage IIIB/IV Non Small Cell Lung Cancer     (NSCLC).   "
136884|NCT01492998|"     In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts     nuclear receptor FXR by either agonists or antagonists respectively increases or decreases     the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal     sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already     been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290:     765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone     given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected     patients.   "
136885|NCT01492985|"     The combination of GTU-MultiHIV B DNA and LIPO-5 vaccines in a prime-boost strategy is     expected to induce strong and diverse HIV-specific immune responses in HIV-infected patients.     The investigators will carry out the clinical therapeutic immunization proof of concept     trial in HIV infected patients. The investigators propose a multi-center double blind     randomized versus placebo phase II clinical trial in patients who are chronic asymptomatic     HIV-infected patients, with undetectable viral load while treated with a potent combination     of antiviral drugs. Patients will continue antiviral therapy combined with either therapeutic     vaccination or placebo vaccination. Patients will undergo the procedure which includes a     prime with the GTU-MultiHIV B DNA vaccine or placebo administered by IM injections via     Biojector (a needle-free injection system) followed by a boost of LIPO-5 vaccine or placebo     also given IM.      In total, 105 HIV-1 patients will be enrolled: 35 in the placebo arm and 70 in the vaccine     arm. Patients will receive antiretroviral treatments and 3 administrations of DNA vaccine or     its placebo at weeks 0, 4 and 12 (corresponding to prime vaccinations). They also receive 2     doses of LIPO-5 vaccines or its placebo at week 20 and 24 (corresponding to boost     vaccinations). At week 36 antiretroviral treatments will be interrupted until week 48.     Patients will be intensely monitored during the treatment interruption period. After start of     cART treatment (at the latest in W48), a data collection from clinical car will be carried     out. A blood sample with W74 will allow to study the persistence ot the immunizing responses,     1 year after the injection of the last vaccine/placebo.      The primary efficacy endpoint is a plasma HIV-1 RNA level at week 48 (e.g. 12 weeks after     stopping all antiviral treatment).      The main hypothesis for conducting a phase II randomized trial is that immune responses in     vaccinated patients may be associated with a better control of viral replication following     c-ART interruption as compared to placebo-vaccinated patients.   "
137099|NCT01490190|"     This study will collect information on cycle control, acceptability and tolerability of the     vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.   "
136886|NCT01492972|"     The purpose of this study is to compare the effects, good and/or bad of two treatment methods     on subjects and their cancer.      Proton beam radiation therapy is one of the treatments for men with prostate cancer who have     localized disease. The benefit of the combination with androgen suppression is not completely     understood. This study will compare the use of hypofraction proton therapy (28 treatments)     alone to proton therapy with androgen suppression therapy.   "
136887|NCT01492959|"     This study is conducted in Asia. The aim of this study is to review the efficacy and safety     of insulin treatment with InnoLet® in daily clinical practice.   "
136888|NCT01492946|"     The aim of this retrospective observational study is to determine the impact of preoperative     nutritional status on postoperative outcome. Elective surgical patients were screened with     Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body     composition. Outcome parameters were collected by patient chart review.   "
136889|NCT01492933|"     Background:      - Studies show that alcohol changes the amount of many brain chemicals. These changes may be     related to continued drinking, craving for alcohol, and relapse. This study will use magnetic     resonance imaging (MRI) to look at brain areas and brain chemistry during an infusion of     alcohol. It will also study how changes in brain chemistry relate to participant reports of     feeling drunk.      Objectives:      - To use magnetic resonance imaging to measure the effect of alcohol on brain chemistry      Eligibility:        -  Individuals between 21 and 45 years of age.        -  Participants will be either light drinkers (1 to 14 standard alcoholic drinks per week)          or heavy drinkers (20 to 40 standard alcoholic drinks per week). A standard drink is a          12-ounce beer, a 4-ounce glass of wine, or a shot of liquor.        -  Participants must be able to go without alcohol for at least 3 days in a row without          severe withdrawal symptoms.      Design:        -  This study requires two or three outpatient visits to the NIH Clinical Center.        -  Participants will have a physical exam and medical history. Blood and urine samples will          be collected. Participants' alcohol drinking habits will also be assessed to determine          whether they may have an alcohol use disorder.        -  At the first study visit, participants will have an infusion of alcohol. Blood samples          will be collected to measure blood alcohol levels.        -  The MRI study visit will take place about 3 days after the first study visit.          Participants will have an MRI scan of the brain, followed by an infusion of alcohol and          another scan. Blood samples will be collected.        -  Participants will complete questionnaires before and after each infusion to measure          their response to alcohol.        -  Heavy drinkers will come to the clinic for a third visit to discuss possible future          treatment and any risky behavior associated with their high levels of alcohol use.   "
136917|NCT01492569|"     This randomized pilot clinical trial studies giving acupuncture in reducing nausea and     vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an     acupuncture point on the inside of the wrist may help control nausea and vomiting during     chemotherapy.   "
136918|NCT01492556|"     The purpose of this study is to determine whether Etoposide Monotherapy is effective and safe     in the treatment of recurrent or metastatic breast cancer in Chinese female patients.   "
136891|NCT01492907|"     Study Design:      This is a single institution pilot study to recruit 4 patients with operable pancreatic     cancer scheduled for a pancreatectomy and 4 age/sex matched normal controls. Both groups will     receive a single oral dose of radiolabeled MelQx followed by serial blood draws over an 8     hour period and urine collections over a 24 hour period. In addition, normal pancreatic     tissue and normal small bowel tissue will be collected by Tissue Procurement from resected     (waste) tissue at the time of pancreatectomy on the 4 pancreatic cancer patients.   "
136892|NCT01492894|"     The purpose of this study is to learn the best way to prolong kidney life in patients exposed     to calcineurin inhibitors, who already have evidence of damage possibly caused by the     calcineurin inhibitor on kidney biopsy.   "
136893|NCT01492881|"     The purpose of this research study is to determine how multiple myeloma responds when the     study drug vorinostat is added to the standard treatment of bortezomib and pegylated     liposomal doxorubicin (PLD). After participants complete the three drug combination and if     their multiple myeloma has decreased, the investigators also want to learn what effects (both     good and bad) when vorinostat and bortezomib are given to people with multiple myeloma over a     longer period of time. This type of treatment is called 'Maintenance Therapy'.   "
136894|NCT01492868|"     The purpose of this study is to investigate the relationship between viral infections of the     upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the     risk of acute bacterial sinusitis over a one year period. The investigators will determine     the incidence of acute bacterial sinusitis post viral upper respiratory infection and     identify the viral antecedent infections and other risk factors which predispose to infection     and ultimately design strategies to reduce the burden of disease and antimicrobial     resistance.   "
136895|NCT01492855|"     The knee menisci are two semicircular fibrocartilaginous structures located between the     articular cartilage surfaces of the femur and tibia in the medial and lateral joint     compartments. The main functions of the menisci are shock absorption and load transmission in     the knee, mainly through distribution of mechanical stress over a large area of the joint     cartilage.      The hypothesis is that primarily older age, meniscal lesion and high pain score at baseline     are associated with poorer outcome.   "
136896|NCT01492842|"     The proposed study is a substudy of ATN 106 and a cross sectional study intended to be     conducted at each of the AMTUs newly participating in ATN III. The intent is to enroll all     youth with behaviorally-acquired HIV who have enrolled in ATN 106. The study involves a     review of the subjects' medical chart and a collection of an oral rinse sample.   "
136897|NCT01492829|"     The investigators will develop, deliver and evaluate a solar powered tablet-based individual     and group focused HIV/STI prevention intervention with internally displaced women in Leogane,     Haiti. Internally displaced women will be trained as community health workers to deliver the     HIV/STI prevention intervention to other internally displaced women.   "
136898|NCT01492816|"     The proposed study seeks to continue Connect to Protect® (C2P) community mobilization efforts     that have developed coalitions that plan for and bring about structural changes for purposes     of reducing HIV incidence and prevalence among youth in targeted communities at nine sites.   "
136899|NCT01492803|"     This is a randomized placebo-controlled trial to examine if once daily probiotic therapy will     lower serum LPS levels and immune activation among HIV-infected youth.   "
136900|NCT01492790|"     The purpose of this study is to evaluate if cholecystectomy first (studied group) versus     sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of     hospital stay, morbidity/mortality and costs in the management of patients with a suspicion     of gallstone migration.   "
137299|NCT01487590|"     For breech presentation, the cesarean section rate is decreased by external cephalic version.     This is a painful operation, with some rare but serious complications. The aim of this trial     is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to     correct breech presentation before 37 weeks of gestation.   "
136901|NCT01492777|"     The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE)     due to a narrow therapeutic window leading to important medical and economical consequences.     The risk of ADE is increased partly by drug interactions and recently identified genetic     factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9)     as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide     reductase complex subunit 1 (VKORC1).      The objective is to determine the impact of several genotypes on acenocoumarol treatment and     on vulnerability to drug-drug interactions.   "
136902|NCT01492764|"     This study will test the hypothesis that many human heart rhythm disorders are caused by     small localized sources, where brief ablation may successfully eliminate the heart rhythm     disorder.   "
136903|NCT01492751|"     The purpose of this study is to evaluate the effectiveness of the three most established     primary treatments for patients with clinically localized prostate cancer (radical     prostatectomy, external-beam radiotherapy, and prostate brachytherapy) at short, mid and     long-term follow-up. The primary aim is assessing Quality of Life impact of treatments' side     effects. As secondary objectives biochemical disease-free survival, overall survival, and     prostate cancer-specific survival will be also assessed.   "
136904|NCT01492738|"     This study endeavors to examine the relationship between acupuncture, anxiety, and     performance on a test of working memory. In the study, all participants will complete the     State-Trait Anxiety Inventory (STAI) survey to determine how anxious they are at the moment     and how anxious they tend to be in general. Then ½ of subjects will receive acupuncture for     20 minutes and ½ will rest quietly for 20 minutes. After this period, all subjects will again     complete the STAI survey. Then all subjects will complete the Automated Operations Span Task     (AOSPAN) which is a computerized test of working memory. Statistical analysis will be     performed to determine if acupuncture had any effect on State-level anxiety and on     performance on the AOSPAN.   "
136905|NCT01492725|"     Patients presenting to the emergency department with acute ischaemic stroke, who are eligible     for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for     dual target major vessel occlusion and mismatch to determine their eligibility for     randomisation into the trial. If the patient gives informed consent they will be randomised     50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or     IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE)     design.   "
136919|NCT01492543|"     The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur     Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female     patients with advanced metastatic breast cancer.   "
136906|NCT01492712|"     Anaesthesia for surgical procedures can be provided using a continuous infusion of     intravenous drug. The most commonly used drug for this technique is propofol. Infusion     devices programmed with pharmacokinetic models can be used to infuse propofol to achieve a     target blood concentration. These pharmacokinetic models predict the rate of distribution of     propofol within the body and also the rate at which it is cleared. In practice, the     anaesthetist enters patient details such as age, sex and weight as well as a target blood     concentration of propofol. The infusion device then infuses propofol at the appropriate rate     to achieve this concentration.      White and colleagues recently published the Covariates Model for propofol. It is anticipated     that this model will have reduced bias and inaccuracy compared to the models in current     clinical use. The VaSCoM study has three objectives:        1. Prospective validation of the Covariates Model        2. Modelling of the effect site concentration of propofol        3. Comparison of propofol concentration in venous and arterial blood samples      To achieve the above objectives, patients over 18 years of age and undergoing elective     non-cardiac surgery will be recruited to the study. Anaesthesia will be delivered using a     target controlled infusion device programmed with the Covariates Model for propofol. The     target blood concentrations will be set according to a pre-determined schedule and all     measurements will be made prior to the start of surgery.      Prospective validation of the Covariates Model will be done by comparing blood concentration     of propofol predicted by the model to those actually measured. These results will then be     compared to the predictions made using the models in current clinical practice.      Modelling of the effect site means predicting the concentration of propofol in the brain for     a given blood concentration. This will involve using depth of anaesthesia monitors (such as     bispectral index) as surrogate markers of brain concentration and comparing this to the     predicted and measured blood concentrations of propofol.      Finally, important information on the distribution and clearance of propofol can be gained     through the comparison of venous and arterial blood samples. In this study, simultaneous     sampling of venous and arterial blood will facilitate this comparison.   "
136907|NCT01492699|"     This is a clinical study for adult subjects with Post Traumatic Stress Disorder.   "
136908|NCT01492686|"     The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via     intravenous drip infusion once a day in the patients with ALS based on the changes in the     revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in     double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186     to the ALS patients.   "
136909|NCT01492673|"     The purpose of this study is to find out what effects, good and/or bad treatment with a new     combination of drugs, cyclophosphamide, topotecan, and bevacizumab has on the patient and     their cancer.      The medications, cyclophosphamide and topotecan, are standard drugs often used together for     the treatment of cancer in children with either Ewing's sarcoma or neuroblastoma.      Bevacizumab is an experimental drug called an antibody that targets a protein important in     the growth of cancer cells called vascular endothelial growth factor (VEGF). VEGF is made by     tumor and other surrounding cells to help make blood vessels needed for the growth and spread     of cancer cells in the body. The way that bevacizumab works is to stop the cancer cells from     making their own blood supply, causing the tumor to stop growing bigger or from spreading. In     adult clinical trials, bevacizumab has shown promising anti-cancer activity in patients with     cancer of the colon/rectum (colorectal) and breast. It has been approved by the Food and Drug     Administration (FDA) for use in patients with colorectal cancer but not in cancers found in     children. Bevacizumab has been tested in early clinical studies in children and has been     shown to be safe.      Other goals of this study will include research tests designed to test the following changes     in the patient or their cancer: to see how the body handles and breaks down bevacizumab     (pharmacokinetics), to look at changes in proteins in the blood that may affect the way the     cancer responds to the combination (angiogenic profile, angiogenesis associated serum     biomarkers), to look at changes in genes that may affect how the cancer responds to treatment     with this combination of medications (metabolic signature), and to monitor the effects of     changes in the way the body grows and develops before and after bevacizumab is given.   "
136910|NCT01492660|"     Patients scheduled for total knee replacements and suitable for sciatic nerve block will be     randomized to one of 2 groups.      Group 1 will have the nerve block performed using a standard Pajunk block needle under     ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement     also guided by electrical nerve stimulation. Group 2 will have the block performed using a     Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound     (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for     catheter location.      An observer blinded to the needle type will assess the quality of needle visualisation on a     recording of the US image taken during the procedure, along with adequacy of spread of local     anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be     block success rate, block performance time, complication rate, number of needle passes per     block, and adequacy of spread of local anesthetic.   "
136911|NCT01492647|"     The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA     after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese     participants with acne.   "
136912|NCT01492634|"     Title of study: Optimizing Fluid Status      Study code: HD-IIT-01-E      Study design: Prospective open design in study centre at two locations      Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload     and dry weight      Aim of the study: To improve the fluid status in chronic HD patients (measured as OH     (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now,     the BCM was occasionally applied in both locations of the study centre.      Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry     weight (post-weight plan)will have significant consequences, namely a decrease of the:        -  time averaged fluid overload (TAFO),        -  proportion of patients with severe overhydration OH > 2.5 L,or OH/ECW > 15 %)        -  proportion of dehydrated patients (OH < -1.0 L, or OH < -7 %),        -  mean overhydration,        -  variance of overhydration,        -  time outside the reference range (-1.0L < OH < 2.5L).      Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM,     Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ;     Body Composition Monitor BCM ; Data management software / database system NephroLink     Disposables used in this study: BVM blood lines and BCM electrodes      Patients: 60 patients   "
136913|NCT01492621|"     Subjects with major depression will be evaluated and intensively characterized through     questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic     resonance imaging will be used to document baseline white matter structure. subjects will     then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks     the evaluations will be repeated.   "
136914|NCT01492608|"     The purpose of the study is to assess whether magnesium sulphate for women at risk of preterm     birth can protect their children against cerebral palsy. The results from this randomised     controlled trial will be added to the previous meta-analysis to obtain firm evidence for     magnesium sulphate as a neuroprotector, and determine whether it should be used as standard     therapy for women in preterm birth.   "
136915|NCT01492595|"     The proposed study aims to establish a pilot program through a prospective cohort study     offering routine contact tracing, investigation and prophylaxis for LTBI, and treatment of TB     disease to children <5 years living in the same household as adults diagnosed with     smear/culture-positive pulmonary TB in Mbarara Regional Referral Hospital   "
136916|NCT01492582|"     This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer     survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine     initiation among young cancer survivors, and (2) determining the immune response to and     safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.   "
136920|NCT01492530|"     The MAALES Project is a community collaborative intervention designed to prevent HIV     infection and transmission among African American men who have sex with both men and women.     The investigators are a collaboration of researchers, community service providers and     activists who are committed to developing and testing effective HIV prevention interventions     that employ holistic and culturally relevant approaches. This includes recognizing the impact     of forces such as racism, homophobia, heterosexism, sexism, and gender expectations on     individual behavior and relationship dynamics in African American communities.   "
136921|NCT01492517|"     Purpose: The purpose of this protocol is to compare the genetic and epigenetic effects     between diesel exhaust and ozone exposure in healthy individuals and in mild/moderate     asthmatics.      Participants: The investigators will recruit up to 30 mild to moderate asthmatics and up to     50 healthy adults to participate in this study.      Procedures (methods): Subjects will be exposed to clean air, to 300 µg/m3 of diesel exhaust     for 2 hours and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled     environment chamber. Primary endpoints will include spirometry and lung cell changes     post-exposure. Secondary endpoints will include analysis of blood clotting/coagulation     factors, Holter monitoring of cardiac parameters, analysis of soluble factors present in     plasma and bronchial lavage and analysis of intracellular factors present in lung tissue     obtained from a brush biopsy.   "
136923|NCT01492491|"     The purpose of this study is to evaluate the serum concentrations of antoxidant vitamines A,     C, E, inflammatory cytokines and middle-large toxins in patients treated with online     hemodiafiltration, standard HFR and SUPRA-HFR.   "
136924|NCT01492478|"     The aim of this study is to do an evaluation of the clinical profile of depression in HCV     patients (newly diagnosed and treatment naïve), and in these same individuals, 24 weeks after     the beginning of IFN+Ribavirin therapeutics (n=100). To characterize depression associated to     HCV with and without interferon (IFN), the investigators will use clinical, behavioral,     biochemical and genetic markers, and to distinguish their different symptomatologic     dimensions.      The control group will be composed by 100 individuals with Major Depression diagnosis, and     not from the general population, because the investigators are not trying to study the     incidence of depression in general population, but to characterize the clinical profile of     patients with HCV (IFN+Ribavirin) compared to major depression.      Thus, the investigators will total 300 evaluations in 200 individuals, 100 from each group,     and considering that the clinical group will be evaluated before the therapeutics and     re-evaluated 24 weeks after its beginning.      Hypotheses        1. Depression in individuals affected by HCV is associated to genetic vulnerability.        2. Genetic vulnerability increases the risk of depression when IFN therapeutics is used.        3. Depression associated to infection by HCV presents a symptomatological profile that is          different from general depression, which is maintained with IFN therapeutics.        4. A higher state of depression in the beginning of a treatment, if not treated, is a risk          factor to abandoning therapeutics.        5. When comparing genders, women present a more severe symptomatological profile than men.   "
136925|NCT01492465|"     The purpose of this study is to determine whether AMG 876 is safe and well tolerated in     subjects with type 2 diabetes.   "
136939|NCT01492283|"     The main objective of this study is to analyze the pathophysiological implications of     glucagon and the incretin hormones in patients with liver disease (Non alcoholic fatty liver     disease (NAFLD) or cirrhosis) with and without diabetes compared with healthy controls. The     present study will contribute significantly to the understanding of the pathophysiology of     liver disease and glucose metabolism. The final goal is that the results could pave the way     for new treatment modalities for patients with liver disease.   "
136926|NCT01492452|"     This is a randomized clinical trial. The population consisted of parents of children     undergoing cardiac surgery from December 2010 to April 2011. We included parents aged over 18     years, and the following were considered exclusion criteria: inability to understand and/or     answer the questions for any reason, parents of children undergoing surgery for insertion of     the pacemaker and defibrillator, surgical death and not take up the case. 22 parents in the     intervention group were randomized and received standardized guidelines for nursing and 22     parents participated in the control group received the guidelines and routine of the     institution. Anxiety was assessed using the STAI State-Trait Inventory in the preoperative     period and 48 hours after surgery the child.   "
136927|NCT01492439|"     The purpose of this study is to determine whether cognitive remediation as an adjunct to     supported education, will result in improved cognitive functioning, symptoms, and performance     in academic domains for persons with psychosis compared to supported education given alone.   "
136928|NCT01492426|"     The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and     Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b     patients   "
136929|NCT01492413|"     This study was designed to test the impact of a 12-week online behavioral modification     program for weight loss, with or without a fortified beverage. Subjects are randomized to     four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling     (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12     weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after     12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after     12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.   "
136930|NCT01492400|"     This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal     implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular     edema (DME).   "
136931|NCT01492387|"     The purpose of the study is to assess the efficacy of an individualized approach to duration     of antibiotic therapy based on each subject's clinical response compared to a local standard     approach in patients coming from the community and who are hospitalized because of a     pneumonia.   "
136932|NCT01492374|"     The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027     on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and     computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly     intravenous (IV) infusions of BMS-241027   "
136933|NCT01492361|"     AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic     acid (EPA) being developed by Amarin Pharma Inc. for the treatment of hypertriglyceridemia.     The purpose of this study is to evaluate whether this drug, combined with a statin therapy,     will be superior to the statin therapy alone, when used as a prevention in reducing long-term     cardiovascular events in high-risk patients with mixed dyslipidemia.   "
136934|NCT01492348|"     The overall objective of this study is to test the effectiveness of a systems-level approach     to primary care recognition and management of PTSD and depression in the military health     system. More specifically, the investigators will test the effectiveness of a telephone care     management with preference-based stepped PTSD/depression care--STepped Enhancement of PTSD     Services Using Primary Care (STEPS UP)--as compared to Optimized Usual Care (OUC).      Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who     are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and     depression symptom severity compared to participants assigned to OUC over 12-months of     follow-up.      Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who are     randomly assigned to STEPS UP will report significantly greater improvements in somatic     symptom severity, alcohol use, mental health functioning, and work functioning compared to     participants assigned to OUC over 12-months of follow-up.      Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to     OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in     terms of dollars per quality adjusted life years saved.      Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians,     care managers, and family members will report that STEPS UP is acceptable, effective,     satisfying, and appropriate PTSD and depression care.   "
136935|NCT01492335|"     Most primary care physicians do not screen older patients for cognitive impairment.     Identification of cognitive impairment may result in earlier referral for diagnostic work-up     and earlier treatment and better patient outcomes. The purpose of this study is to determine     whether physicians who receive the results of a cognitive screen use this information in     treatment plans and whether this results in better cognitive outcomes for the older patients.   "
136936|NCT01492322|"     A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is available     at the synapse and this may affect the underlying reasons for relapse in smokers. This     research will use Single-photon emission computed tomography SPECT and the DAT-specific     ligand, TRODAT (Dopamine Transporter Density by [99mTc]), to examine the availability of DAT     in smokers grouped by genotype in the sated (just having smoked) and withdrawal (4 hours     without smoking) conditions.   "
136937|NCT01492309|"     The purpose of this study is to determine if repetitive transcranial magnetic stimulation     (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.      TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more     effectively with one another. Effective neuron communication is thought to lead to the     lessening of depressive symptoms. In this study subjects require daily TMS treatment for     approximately four weeks.   "
136938|NCT01492296|"     Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty     stomach is required to ensure quality and safety. For this reason, endoscopy is     conventionally performed after 8 or more hours of fasting, which is potentially related to     discomfort to the patients. In recent studies, surgical cholecystectomy has been described to     be safe after two hours of fasting on liquids. The aim of this study is to assess safety,     quality and comfort of upper GI endoscopy after two hours of fasting.   "
136964|NCT01491958|"     Phase II trial evaluating the safety & efficacy of Atorvastatin for prophylaxis of Acute     Graft Versus Host Disease (GVHD) in patients with hematological malignances undergoing human     leukocyte antigen (HLA)-Matched Related Donor Hematopoietic Stem Cell Transplant (HSCT).   "
136940|NCT01492270|"     The incidence of prostate cancer is rising however the number of deaths from prostate cancer     is stable. Meaning the investigators are diagnosing many men with prostate cancer that will     not impact on their life. The rise in incidence is mainly due to increased use of the blood     test Prostate Specific Antigen (PSA), as a screening test.      Currently men suspected of having prostate cancer, identified by a raised PSA undergo     trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test     unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as     it is random and performed blind-the operator does not know where the cancer is. Thus many     low-risk cancers that do not need treating are diagnosed and many high risk cancers are     missed or incorrectly classified. So, men with a negative biopsy or those with low risk     disease are usually advised to undergo another TRUS biopsy.      An imaging test is needed that could help men and their doctors decide whether the biopsy is     a true reflection of what is inside his prostate.      The investigators will test the role of two imaging tests. The first, multi-parametric     magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The     second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the     results of these tests with a detailed biopsy map-transperineal template prostate mapping     biopsy (which is currently the best way to find out what is in the prostate but requires     multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one     or more TRUS biopsies and who have been advised to have further tests on as part of standard     of care. They will be recruited from UCLH referral letters and clinics.      The investigators aim is to see if either of these tests can confidently rule out the     presence of clinically important disease.   "
136941|NCT01492257|"     Total joint arthroplasty (TJA) is an effective procedure for reducing pain and improving     function in patients with disabling osteoarthritis (OA) of the hip or knee. However, as with     all invasive procedures, TJA is associated with certain risks and substantial costs. Since     the indications for TJA are heavily dependent on patients' quality of life and expectations.     TJA utilization rates vary widely throughout the United States, as seen with other     'preference-sensitive' procedures. Early evidence suggests shared decision making (SDM)     strategies are effective in enhancing patient decision quality, or the degree to which     treatment decisions reflect the preferences of fully informed patients, especially for     preference-sensitive procedures like TJA. Despite these advantages, however, SDM has not been     embraced or widely adopted in orthopaedics. To investigate this limited uptake, the     investigators propose a series of evaluations of individual-level strategies. The     investigators innovative and unique contribution is to approach patients, surgeons and     healthcare purchasers as having symmetric and equally valid concerns about the benefits and     cost associated with SDM. The investigators overall objective is to facilitate wider     dissemination of SDM strategies in orthopaedic practices. The specific aims of the project     are to assess, for SDM strategies, the impact on key patient, surgeon, and healthcare     purchaser priorities; By achieving this aim our project will produce new interventions and     incentives for disseminating SDM that are endorsed as feasible and acceptable by a coalition     of patients, surgeons, and purchasers. The investigators plans for evaluation include a     randomized controlled trial to evaluate the impact of SDM on outcomes of interest to     patients, surgeons, and purchasers.   "
136942|NCT01492244|"     Blank has designed a medical diagnostic system in the form of an unvalidated online     questionnaire and drawing tool used to describe and identify the location of knee pain,     respectively. A component of the survey includes the patient inputting their diagnosis as the     etiology of their knee pain. Dr. Ivo Dinov's team has used the data from 100,000 patient     surveys to construct a probabilistic model to diagnose those who fill out the questionnaire     and knee pain map but do not have a diagnosis. However, the validity of the online survey and     the accuracy of the probabilistic model has not been confirmed in patients with known     diagnoses. Therefore, the purpose of this study will be to recruit patients with knee pain at     UCLA orthopedic clinics to complete the online survey which will then be applied to the     probabilistic model to output possible diagnoses. The results will be compared to the actual     diagnosis assigned to that patient in the clinic. If validated, the online survey may serve     as a tool for diagnostic and research purposes.   "
136943|NCT01492231|"     The main purpose of the protocol is to collect and evaluate performance data after patients     undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive     Digestive Disease Center (CDDC).   "
136944|NCT01492218|"     This study is conducted in Asia. The aim of this study is to assess patient satisfaction     after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as     treatment for diabetes mellitus under normal clinical practice setting.   "
136945|NCT01492205|"     This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance     of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital     environment.   "
136946|NCT01492192|"     The goal of this clinical research study is to look at 2 new methods of scanning and see     whether they can help researchers predict which tumours will respond to drugs that attack     tumour blood supply.   "
136947|NCT01492179|"     Local anesthetics (LA) are increasingly used for postoperative pain management.     Speicifically, several studies have found benefit of LA injected intra-abdominally following     abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to     local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The     aim of this study is to assess whether lidocaine administered intravenously has similar     analgesic efficacy as the same dose administered intra-abdominally in patients undergoing     abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled     analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.   "
136948|NCT01492166|"     This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and     convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic     agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.   "
136949|NCT01492153|"     This study is conducted in Asia. The aim of this study is to investigate the safety and     efficacy of NovoLet® human insulin delivery system in an outpatient setting.   "
136965|NCT01491945|"     The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is     safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.   "
136966|NCT01491932|"     This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients     who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias     (PD-LID).   "
137259|NCT01488110|"     The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of     migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks,     and presence of a preventive effect two months post treatment. Another purpose is to     investigate if and how this treatment affects manifestations of the autonomic nervous system     activity.   "
136950|NCT01492140|"     The purpose of this study is to characterize the safety and performance in normal therapeutic     use of the Artiste System in comparison to standard manual administration of dermal fillers.     Subjects are recruited from the investigator's practice and randomized to receive treatment     with the Artiste System on either the left or right nasolabial fold, the contralateral fold     to be treated with standard manual injections. Treatments occur in a single session to     achieve optimal cosmetic results (OCR) balanced on both sides. Investigators are encouraged     to use a variety of types and brands of dermal fillers, recruiting subjects for the study as     necessary. Safety and performance evaluations will be made through a combination of clinical     observations, questionnaires for the subject and for the Treating Investigator, and     spontaneous reports of adverse events. There are 6 required study visits: Screening, Day 1     (Treatment Day), Day 3, Day 8, Day 15, and Day 29.   "
136951|NCT01492127|"     This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of     hepatocellular carcinoma (HCC) by studying their variation following curative treatment of     HCC. The hypothesis of the study is that plasma proteasome levels will decrease following     curative treatment, and that proteasome levels could be used as a marker to detect early     recurrence.   "
136952|NCT01492114|"     This research will investigate the hypothesis that resveratrol when given orally to healthy     adult smokers induces a decrease in the inflammatory and oxidative mediators which     characterize the low-grade systemic inflammatory state and the oxidants-antioxidants     imbalance of tobacco users.   "
136953|NCT01492101|"     The study is designed as an open-label, randomized, parallel, two arm, multicenter,     international Phase 3 study in patients with recurrent or metastatic breast cancer previously     treated with cytotoxic chemotherapy regimens.      The primary study objective is to compare overall survival of patients who receive NKTR-102     given once every 21 days to patients who receive treatment of Physician's Choice selected     from a list of seven single-agent intravenous therapies.   "
136954|NCT01492088|"     The purpose of this study is to assess the safety and pharmacokinetics, and determine the     pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.   "
136955|NCT01492075|"     The investigators hypothesis is that patient controlled local anesthetics administered     intraabdominally are more efficacious compared to continuous infusion in reducing     postoperative pain and morphine consumption.   "
136956|NCT01492062|"     You are invited to participate in a research study for the development of an artificial     pancreas. An artificial pancreas uses a program which takes information from a continuous     blood glucose monitor and uses that information to tell an insulin infusion pump how much     insulin to deliver. The primary purpose of this study is to gain experience with insulin     delivery algorithms or programs program (algorithm) provides the best regulation of glucose     levels so that there are no severe low blood glucose reactions and blood glucose levels are     generally between 70 to 180 mg/dl.   "
136957|NCT01492049|"     The goal of this study is to test patient education program for decision making about     colorectal cancer (CRC) screening in community health centers.   "
136958|NCT01492036|"     The goal of this clinical research study is to collect information about the long-term safety     of gene transfer therapy. This study is also designed to create a database of medical     information about patients who have received gene transfer therapy, in order for researchers     to track and review the long-term safety and any effects (good or bad) of gene transfer     therapy.   "
136959|NCT01492023|"     The purpose of this study is to determine whether neuropsychological rehabilitation focused     on attention retraining and teaching compensatory strategies has positive effects on     cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with     MS. The hypothesis is that the neuropsychological intervention shows positive effects on     cognitive performance, QoL and perceived cognitive deficits.   "
136960|NCT01492010|"     Muscle mass is normally maintained through the regulated balance between the processes of     protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old     muscle proteins). Proteins are composed of amino acids and we know that amino acids increase     muscle protein synthesis. However, not all amino acids are the same. Essential amino acids     are ones that must be consumed through food, while non-essential amino acids can be made by     our body. Interestingly, the essential amino acids are all that are required to increase the     rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to be     particularly important in regulating protein synthesis. However, how leucine is able to     increase protein synthesis is not entirely understood. Previously, it has been shown that     20-25 g of high-quality protein, such as that found in milk, appears to be the amount of     protein that maximizes the rate of muscle protein synthesis after performing a bout of     resistance exercise. Thus, we aim to measure the synthesis of new muscle proteins after     ingesting the following:        1. 25g whey protein        2. 6.25g whey protein supplemented with leucine        3. 6.25g whey protein supplemented with essential amino acids but no leucine      Thus, we will measure muscle protein synthesis after consumption of the above beverages in a     leg that has done no exercise ( ie. a rested leg) and in the other leg that has done     resistance exercise. We hypothesize that 6.25g whey supplemented with leucine will stimulate     muscle protein synthesis as effectively as 25g whey, but that 6.25g whey supplemented will     all the essential amino acids except whey will be less effective at increasing muscle protein     synthesis. Whey protein is a dairy based protein found in cow's milk, thus when you drink a     glass of milk you are consuming some whey protein. However we are using an isolated form of     whey protein, meaning it has been removed from milk. As mentioned previously, amino acids are     'strung-together' to make protein. The 'essential' amino acids must be consumed through food     because our body cannot make them, thus they are consumed when you eat protein rich foods     like milk or chicken.   "
136961|NCT01491997|"     Stress has been linked to chronic health problems, particularly diseases involving     inflammation-mediated tissue injury and organ failure. Accordingly, it is not surprising that     mind/body interventions are advocated for treatment of chronic inflammatory diseases. One     such candidate disease is ulcerative colitis (UC) because: (1) UC is a life-long, relapsing,     disabling inflammatory disorder of the intestine that lacks a non-toxic, efficacious     treatment; (2) the therapeutic goal is to improve quality of life by ameliorating disabling     symptoms and preventing disease progression by preventing disease flare-up, (3) stress     triggers UC flare-up by modifying intestinal function and inflammatory processes,     highlighting the potential therapeutic benefit of reducing physiological stress responses.     The purpose of this study is to see if either of two 8-week mind/body medicine courses has an     effect in reducing stress and affecting the course and severity of UC. Both have been shown     to benefit other aspects of health and well-being.   "
136962|NCT01491984|"     A laryngoscope is a medical instrument that is used to get a view of the voice box and the     space in between the vocal cords. A laryngoscope is used to place a breathing tube into the     trachea (windpipe or airway) to protect the patient's airway and provide a way to help a     person breathe during surgery; this is called intubation.   "
136963|NCT01491971|"     Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients     with Prostate Cancer.   "
136967|NCT01491919|"     The drug lisinopril is approved by the U.S. Food and Drug Administration for the treatment of     high blood pressure, heart failure, and acute heart attacks in adult patients. In children     over 6 years of age, lisinopril is approved for the treatment of high blood pressure.     Lisinopril is in a group of medications called angiotensin-converting enzyme inhibitors     (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals that tighten     the blood vessels so blood flows more smoothly and the heart can pump blood more efficiently.      There is some information available about how children with high blood pressure absorb,     distribute, metabolize, and eliminate lisinopril (this information about medication     processing by the body is called pharmacokinetic data). However, there is no information     about how children with high blood pressure who have received a kidney transplant process     lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril     may help kidney transplants work longer by reducing the activity of chemicals made by cells     in kidney transplants that can lead to inflammation and injury. Such benefits have not been     found with another group of blood pressure medications called calcium channel blockers, which     are the most commonly used medication group to control high blood pressure in children after     a kidney transplant. A clinical trial will be conducted in the future to compare which     medication group helps kidney transplants in children last longer. To guide the selection of     the best dose to test in future studies, investigators in this study will try to determine     the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and     adolescents (2-17 years of age) who have received a kidney transplant and have high blood     pressure.   "
136968|NCT01491906|"     The purpose of this study is to test the effect of a mobile phone-assisted lifestyle     intervention on weight loss at 6 months among overweight/obese Chinese adults, as compared to     a control group.   "
136969|NCT01491893|"     Purpose of the Study:      To determine the maximally tolerated dose (MTD) or the Phase II dose of PVSRIPO when     delivered intracerebrally by convection-enhanced delivery (CED). To obtain correlative     mechanistic evidence of PVSRIPO's effects on infected WHO Grade IV malignant glioma tumors     and to estimate progression-free survival (PFS) and overall survival (OS) in recurrent WHO     Grade IV malignant glioma patients. To obtain information about clinical response rates to     intratumoral inoculation of PVSRIPO. To estimate the efficacy of PVSRIPO administered at the     optimal dose.   "
136970|NCT01491880|"     This pilot study will examine the feasibility of two modes of service delivery (e.g., a     minimal therapist contact, self-help program, and a more intensive therapist supported,     telephone-based approach) in a rural, primarily Latino, population. These modes of delivery     may ultimately improve access to evidence based treatments and mental health outcomes among     underserved groups.   "
136971|NCT01491867|"     Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more     information on the drug-related IOP change than 24-hour IOP measurement with Goldmann     applanation tonometry (GAT.   "
136972|NCT01491854|"     This study is performed as part of the Marketing Authorisation Holder's post-marketing     pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic     potential and immunogenicity of rhGH therapy in short children born small for gestational age     (SGA).   "
136973|NCT01491841|"     Part 1: This is a phase I trial of the combination of bendamustine, rituximab and pixantrone     in patients with relapsed/refractory B cell non-Hodgkin lymphoma. A standard 3+3 design will     be used to determine the maximum tolerated dose (MTD) of the combination. A static dose of     bendamustine and rituximab will be used and the dose of pixantrone will be escalated in each     cohort. Pixantrone will be dosed on a 21 day cycle at 55mg/m2, 85mg/m2, and 115mg/m2 in     sequential cohorts dependent on acceptable toxicity profile at each dose level. MTD will be     determined based on DLTs that occur during the first 2 cycles of the drug combination.      After 2 cycles of study drug, all subjects achieving stable disease or better may continue on     study for up to 6 cycles. However, adverse events occurring during cycles 3-6 will not be     considered DLTs and will not contribute to the determination of the MTD.      Part 2: After the MTD is determined an expansion study is planned. This will be a phase II,     prospective, open label, single arm study of combination therapy with bendamustine,     rituximab, and pixantrone at the defined MTD schedule based on the phase I portion of this     study. Subjects enrolled in part 2 of the study must have an aggressive, relapsed or     refractory B-cell NHL, to include follicular lymphoma (FL) grade 3, Diffuse Large B Cell     Lymphoma (DLBCL), transformed NHL, mantle cell lymphoma (MCL), and other aggressive     histologies. We anticipate the total sample size to be 36 patients accrued at a rate of 2     patients per month. Restaging will be employed after cycle 2, and if the patient has stable     disease or better they may continue on study for up to 6 cycles.   "
136974|NCT01491828|"     This study will validate whether an external vibratory stimulus applied to a subject's neck     causes head, neck or jaw movement.   "
136975|NCT01491815|"     This is an international (Nordic) trial designed to compare the safety and efficacy of active     conventional therapy (ACT) and three biologic treatments in subjects with early rheumatoid     arthritis (RA). The global aim of this study is to assess and compare        1. the proportion of subjects who achieve remission with ACT versus three different          biologic therapies (Certolizumab-pegol, Abatacept or Tocilizumab)        2. two alternative de-escalation strategies in patients who respond to first-line therapy.   "
136996|NCT01491542|"     The purpose of this pilot clinical trial is to evaluate the feasibility of using the     investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON®     Spinal System) as a method of facilitating spinal fusion in patients with symptomatic     degenerative disc disease.   "
136997|NCT01491529|"     This study will assess the efficacy and safety of modified release AFQ056 in patients that     have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)   "
136998|NCT01491516|"     The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™     Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a     method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in     patients with symptomatic degenerative disc disease. The safety and effectiveness of the     implant will be evaluated.   "
136999|NCT01491503|"     The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium     and levocetirizine dihydrochloride in healthy male volunteers.   "
136976|NCT01491802|"     Preliminary information from our laboratory indicated that even patients with milder chronic     obstructive pulmonary disease (COPD) can have significant physiological derangements which     become more pronounced during exercise, leading to intolerable dyspnea at lower levels of     ventilation than in health. This study will explore pathophysiological mechanisms of dyspnea     and activity limitation in GOLD stage II COPD and will determine if there is a sound     physiological rationale for the use of dual long-acting beta2-agonist (LABA)/long-acting     muscarinic antagonist (LAMA) therapy (GSK573719/ GW642444 Inhalation Powder) versus LAMA     alone (GSK573719) as treatment for dyspnea and exercise intolerance in this subpopulation.     Objectives of this study are to determine if: 1) neuromechanical uncoupling of the     respiratory system contributes to exertional dyspnea in milder COPD, and 2) treatment with     LABA/LAMA improves dyspnea and exercise endurance compared with LAMA by improving     neuromechanical coupling. The investigators hypothesize that: 1) dyspnea is related to     excessive dynamic lung hyperinflation, tidal volume restriction and increased ratio of     central respiratory neural drive to tidal volume displacement, a measure of neuromechanical     uncoupling of the respiratory system, and 2) LABA/LAMA will improve dyspnea and exercise     endurance, which will be explained by partial reversal of the above mechanical abnormalities.     The investigators will conduct a randomized, double-blind crossover study and compare the     effects of once-daily LABA/LAMA over 4-weeks with LAMA on dyspnea, exercise endurance and     ventilatory mechanics in GOLD stage II COPD.   "
136977|NCT01491789|"     The research is being done to look at the benefits of a recreational and therapeutic program     for people with spinal cord injury using the VSail-Access sailing simulator.   "
136978|NCT01491776|"     The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to     accurately test a throat swab specimen from a symptomatic patient for the presence or absence     of Group A Streptococcus (Strep A) when compared to culture.   "
136979|NCT01491763|"     20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the     Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy     followed by hematopoietic stem cell transplantation (HSCT) have formed the basis allogeneic     treatment of this disease, but the results have been poor (60-75% complete remissions-RC-and     probability of long-term survival less than 20%). The effectiveness of imatinib for     hematologic responses in patients with Ph + (observed in phase I and II) led to its use in     phase III trials in combination with chemotherapy. They saw a chance of obtaining the RC     above 90%, with acceptable toxicity, a molecular response rate (MR) of 40-50%, and prolonged     follow-up studies, a probability of disease-free survival (DFS ) of 30-50%, significantly     higher than historical controls with the same chemotherapy without imatinib. This led to the     approval of imatinib by the rating agencies in the U.S., Europe and Japan as a treatment for     Ph + in combination with chemotherapy.      Of the studies that led to the approval of this indication for imatinib, and other incurred     after, the following conclusions can be drawn:      There is no specific pattern of combination of imatinib (at doses of 600 mg / day, po) and     chemotherapy. However, when compared with concomitant alternating with the first achieved a     higher rate of RM at the end of induction, although this did not influence DFS.      In studies in elderly patients has achieved a high CR rate (almost 100% in all series), only     imatinib and glucocorticoids, suggesting that an attenuated induction may be sufficient to     achieve CR in young patients with minimal toxicity, which further compromises the     administration of treatment and allow for an allogeneic HSCT with minimal toxic load     possible.      Although there is no consensus on the indication of allogeneic HSCT in first CR when given     imatinib associated with intensive chemotherapy is an option that is done in most studies.      The allogeneic HSCT is most effective when carried out in complete molecular response to or     greater than when there is more residual disease. However, the impact of MRI to obtain early     (after induction) on survival is not clear. So far-reaching goal is to make the TPH in     complete molecular response situation or greater.      The relapse of the disease at the molecular level is still short-term (less than 3 months) of     hematological relapse. This implies the need for frequent monitoring of residual disease (ER)     The frequency of relapse post HSCT is high (around 30%), raising the need for any post HSCT     treatment, including imatinib included. Are currently ongoing clinical trials comparing the     systematic administration of imatinib after administration TPH face is detected only when ER.      The applicability of the administration of imatinib after HSCT is limited by toxicity related     to the procedure of TPH, is making frequent dose reduction or discontinuation.      Therefore, a reasonable approximation treatment of Ph + outside the context of a clinical     trial is to get as many molecular responses before allogeneic HSCT in a position to make the     same MRI complete or greater. After TPH, must be very close monitoring of the ER, and     imatinib is administered as soon as you notice the loss of molecular response.      In patients who can not make an allogeneic HSCT for lack of histocompatible donor or     contraindications for its realization it is recommended imatinib and chemotherapy, although     there are studies that have undergone an autologous HSCT, followed or not treatment     maintenance with imatinib. The low toxicity of autologous HSCT and no effect of graft     versus leukemia are strongly recommended the administration of maintenance therapy with     imatinib combined with chemotherapy or not.   "
136980|NCT01491750|"     The purpose of this mixed methods pilot study is to produce preliminary data for a     randomized, placebo-controlled trial testing a biobehavioral model of the effects of guided     imagery on outcomes of total knee replacement surgery.   "
136981|NCT01491737|"     This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy     and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in     first-line participants with HER2-positive and hormone receptor-positive advanced breast     cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in     combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may     also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the     investigator's discretion in combination with the assigned treatment arm. The anticipated     time on study treatment is until disease progression, unacceptable toxicity, withdrawal of     consent, or death whichever occurs first.   "
136982|NCT01491724|"     The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation     in Gastric Intestinal Metaplasia (GIM)      Objective:      The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM.      Research design:      Blinded review of pCLE images for the diagnosis of GIM      Sample size:      Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips      Data analysis:      ROC curve is analyzed by SPSS version 16.      Expected Benefit and Clinical Application Information on the learning curve for GIM     interpretation from pCLE images in order to develop early gastric cancer detection   "
136991|NCT01491607|"     The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of     BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this     study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.      This study will be conducted in the United States (U.S.), in 200 healthy male and female     volunteer subjects ages 18 to 65 years.      The duration of study participation for each individual subject will be approximately 128     days (4.25 months), including a screening period of approximately 28 days followed by 100     days on study.   "
136983|NCT01491711|"     Skin cancer is the most common cancer in Caucasians, and a basal cell carcinoma (BCC) being     the most common skin cancer with around 44,000 new tumours per year, and its incidence is     still rising. In the past it has been a disease of the elderly patient but as a consequence     of recreational sun exposure and tanning beds, more young patients develop a skin cancer as     well. There are different subtypes of BCC and most subtypes are treated by surgical excision.     Nowadays, non-invasive techniques as photodynamic therapy (PDT) are common practice to treat     superficial BCC (sBCC). Because of these techniques treatment by surgical excision can be     avoided with the possibility of complications and scar formation. Both 5-aminolevulino acid     (5-ALA) and the more lipophilic methyl aminolevulinate (MAL) can be used as a precursor of     the photosensitiser. These agents generate an excess of protoporphyrin IX in metabolic active     cells, which are illuminated by a specific light source leading to release of reactive oxygen     radicals in tissue. The result is apoptosis and necrosis of tumour cells. At the moment, two     treatment protocols are used in the Netherlands: the fractionated 5-ALA 20% (Fagron) protocol     according to de Haas and the MAL (Metvix, Galderma) protocol. Because MAL was first marketed     and registered as a treatment option for premalignant and superficial malignancies most     hospitals in the Netherlands use this topical agent. However, there is no evidence which of     the 2 agents is more (cost-)effective and/ or preferred by patients.      Objective: to determine which treatment is the most effective treatment in terms of     prevention of treatment failure, cost saving and patients preference when comparing     fractionated 5-ALA 20% PDT versus MAL PDT in 2 treatment sessions.   "
137023|NCT01491191|"     Postsurgical pain becomes chronic when it lasts more then two months after surgery. A     neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates     after urologic and gynecologic surgeries.      Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors     release, without adverse events.      The investigators assume that perioperative administration of PEA can reduce chronic     postsurgical pain incidence of patients undergoing to urologic and gynecologic elective     surgery.   "
137024|NCT01491178|"     To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with     nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic     embolism (SEE).   "
136984|NCT01491698|"     This study is being done to learn more about how different surgery procedures bring back the     eating pathway after removing the stomach in patients with stomach cancer. If the surgeon has     decided that some, or all, of the patient's stomach must be removed the surgeon must create a     new way to allow food to travel from the mouth to the intestines. Some patients develop     problems because they are missing their stomach, such as lack of hunger, bloating, cramping,     and heartburn.      The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if     a change in surgery can help reduce these symptoms.      The most common method of creating a way for food is called a Roux-en-Y, in which one part     of the intestine is connected with the end of the esophagus (the swallowing tube) in the     abdomen, and another connection is made between the intestines lower down.      The change in surgery involves creating a pouch from a part of the intestines to replace the     stomach.      This study will compare the effects, good and/or bad, of gastric pouch reconstruction with     the usual reconstruction to see if the pouch makes you feel better overall.      This type of surgery has been used by some surgeons for many years and is known to be safe,     but it is not known if it reduces symptoms or improves nutrition compared with the usual     surgery.   "
136985|NCT01491685|"     This is an observational study comparing microcirculation of pregnant to non-pregnant women.     Microcirculation means blood flow to the extremely small blood vessels in one's body.     During pregnancy the amount of blood in a woman's body increases. The body responds to this     increase by pumping more blood through the heart and narrowing the size of blood vessels.      There are many types of blood vessels that have different roles in the body. Larger blood     vessels. Transport blood to and from body organs like the brain and liver. Small vessels     (microcirculation)distributes blood to the organ tissues. The microcirculation can change     blood flow and blood pressure. Microcirculation is involved in delivering oxygen and     nutrients to your body, removing waste products, and regulating body temperature.      The investigators current understanding of the microcirculation in pregnant women is limited.     There is a device available that can measure microcirculation. It is known as Sidestream Dark     Field (SDF) imaging. It is a special type of camera that captures pictures of the     microcirculation. In this study the investigators will compare the microcirculation, as seen     with SDF imaging, of pregnant women to non-pregnant women. By improving the investigators     understanding of maternal microcirculation the investigators are adding to the knowledge of     how the pregnant body works. The investigators hope to then translate this knowledge into     further studies to improve maternal and fetal outcomes through prevention and treatment of     maternal low blood pressure caused by spinal anesthesia.   "
136986|NCT01491672|"     This study will evaluate everolimus as second-line therapy in patients with metastatic renal     cell carcinoma. Each patient will be enrolled and stratified in one of three cohorts based     upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF     therapy other than sunitinib.   "
136987|NCT01491659|"     It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side     effects related to the use of antibiotics   "
136988|NCT01491646|"     Pulmonary hypertension (PH) is a condition in which high blood pressure develops in the lungs     and right side of the heart. People with PH suffer from shortness of breath, chest pain,     heart failure, heart rhythm problems, and fainting. PH is diagnosed using a test called a     cardiac catheterization where blood pressure is measured directly using a tube placed in the     right side of the heart and lung arteries. Because a cardiac catheterization is invasive,     researchers are investigating ways to diagnose PH using imaging tests that are not invasive.     The study will evaluate whether or not a magnetic resonance image (MRI) of the heart, and     blood tests can detect PH.   "
136989|NCT01491633|"     Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has     been used in treatment for other types of cancer and information from other research studies     suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially     in individuals whose tumor has a mutation in the DDR2 gene.      Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic     targets are needed. Several studies have examined dasatinib in NSCLC; these report     significant toxicities, but also responses in patients found to harbor mutations in DDR2 or     BRAF.      An open-label phase II trial with dasatinib was carried out to determine the response rates     in patients with SqCC who had previously failed standard chemotherapy and to correlate     responses with patient genotype.   "
136990|NCT01491620|"     This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the     treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).   "
136992|NCT01491594|"     The purpose of this study is to study the effect of eltrombopag on chemotherapy induced     thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood.     Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.   "
136993|NCT01491581|"     The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar,     specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium     on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium     and iron status, and on their cognitive performances.   "
136994|NCT01491568|"     The purpose of this study is to evaluate the feasibility of using the investigational implant     (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral     lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic     degenerative disc disease.   "
136995|NCT01491555|"     Researchers at Children's Hospital Boston Neurology Department invite children to participate     in a new research study. Researchers are looking for boys ages 2 - 30 with Duchenne Muscular     Dystrophy (DMD) and healthy boys ages 2 - 30 (without any nerve or muscle concerns) to serve     as controls. The study is evaluating a new technique that will test nerve and muscle     function. The testing is all pain free.      Children participating in the study will come in for 10 visits over two years. Visits will     take place every month at first, then less often for the remaining visits. The tests for the     study itself take approximately 2hours. If participants are interested or would like to learn     more about the study, please call Lavanya Madabusi at 617-919-3554 or     Lavanya.Madabusi@childrens.harvard.edu. All inquiries will be kept strictly confidential.   "
142193|NCT01423279|"     This research is NOT part of an interventional trial, however the investigators use umbilical     cord after birth for isolating endothelial and smooth muscle cells for academic research.   "
137000|NCT01491490|"     Olanzapine is one of the most effective and best tolerated of the atypical antipsychotics,     but it is also particularly associated with weight gain and metabolic problems.      This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the     efficacy and safety of two medications GW42003 and GW42004 as a 40:1 ratio when combined with     the subjects existing treatment of olanzapine in subjects with weight gain attributable to     olanzapine treatment for functional psychosis. This is the first study to determine whether     the study medications have a positive benefit for subjects on their cholesterol levels, body     weight and other metabolic parameters, as well as a potential augmentation of the     anti-psychotic effect of olanzapine.      This is a multi-centre randomised, double-blind, placebo-controlled, parallel-group pilot     study. There will be two groups of subjects (GWP42003 plus GWP42004 (40:1 ratio) and     placebo), with a treatment duration of 6 weeks as well as a baseline period of variable     length and one week follow-up. The two treatment groups will be randomised equally.      In order to be eligible for enrollment in this study, subjects will need to be aged 18 years     and above and be clinically diagnosed with functional psychosis and receiving olanzapine     treatment for no more than 3 months with evidence of weight gain attributable to olanzapine     treatment.      Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline     period. Subjects will also be assessed at Visit 2 for further weight gain during the baseline     period. The baseline period is flexible in length to allow time for this weight gain to be     achieved and also for the olanzapine dose to be stabilised. If eligible the subject will be     randomised into the 6-week treatment phase. There are a total of 6 visits in the study.   "
137001|NCT01491477|"     The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™     Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal     fusion in patients with cervical symptomatic degenerative disc disease.   "
137002|NCT01491464|"     The purpose of this clinical trial is to assess the safety and effectiveness of the     rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with     symptomatic degenerative disease.   "
137003|NCT01491451|"     The purpose of this pilot clinical trial is to evaluate the device design as a method of     facilitating spinal fusion.   "
137004|NCT01491438|"     OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors     (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the     safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN:     Randomized, open clinical trial in parallel groups, controlled with conventional treatment.      SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous     ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental     group: Autologous PRGF administrated once a week (day 1) + conventional treatment     administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where     there has been no complete healing in this period, patients will continue the same management     protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12     weeks of treatment.      Conventional treatment includes: Cleaning and debridement of the wound, the application of     corresponding dressing, and using of antibiotic if necessary in each visit.      STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude     model and the adjusted model (for confounding variables)will be built. The healing time of     ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding     comparison using the log rank test.   "
137005|NCT01491425|"     This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE®     Device using laparoscopic surgical technique as compared to an historical control group     treated with Autogenous Bone/LT-CAGE® Device using an open surgical technique in patients     with symptomatic degenerative disc disease.   "
137006|NCT01491412|"     This is an observational study describing the real-life antipsychotic treatment during the     hospitalisation of the patients due to acute psychotic episode.      In this NIS subject's data will be collected at one visit at the moment of discharge from the     hospital.      The results of the study would help to characterise the discrepancy between current clinical     practice and treatment guidelines, indicating that atypical antipsychotics are preferable and     should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia.     Available evidence have revealed a frequent use of first-generation antipsychotics,     polypharmacy, intramuscular route of administration and use of atypical antipsychotics in     doses lower than recommended in registered summary of product characteristics.   "
137007|NCT01491399|"     The purpose of this clinical trial is to assess the safety and effectiveness of the     Investigational implant as compared to the Control implant in the treatment of patients with     one level or two adjacent levels of cervical symptomatic degenerative disc disease.   "
137008|NCT01491386|"     This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE®     device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic     degenerative disc disease using an open surgical technique.   "
137009|NCT01491373|"     This study is designed to evaluate the feasibility of recombinant human bone morphogenetic     protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® )     for anterior lumbar interbody fusion in patients with degenerative disc disease.   "
137010|NCT01491360|"     A new minimally invasive procedure for treating presbyopia is being evaluated to determine if     there is improvement in near and intermediate vision after treatment.   "
137025|NCT01491165|"     Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are     high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell     with self-and directed differentiation capacity can effectively rescue experimental liver     failure and contribute to liver regeneration, which suggests the feasibility of stem cell     transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma     stem cell transplantation through interventional procedures in patients liver cirrhosis will     be evaluated.   "
137100|NCT01490177|"     The Primary Objective of the study is to develop a customized regimen for oral immunotherapy     that reflects what the subject is allergic in a clinically significant way (i.e., the     offending food allergen is defined as a food allergen with a positive skin test or positive     specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single and     multiple food allergy subjects are included in the study.   "
137011|NCT01491347|"     Alcohol dependence is accompanied by several neurological mechanisms involving neuronal     plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF) synthesis.      The investigators found that serum BDNF levels in alcohol-dependent subjects increased to a     greater extent in subjects who had remained abstinent at 6 months after withdrawal than in     subjects who had relapse.      To verify if the BDNF serum levels variation is linked to the way that abstinence is     installed, wthe investigators will measure BDNF serum levels in alcohol dependent subjects at     the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its     evolution in relation to alcohol consumption, and other clinical characteristics : depression     intensity, anxiety, alcohol craving, biological markers of alcohol consumption or toxicity.     Monitoring serum BDNF concentrations in link with other clinical data could help to     characterize alcohol dependence profiles in clinical practice, help predict relapses, and     assist in adjusting care to prevent difficulties in alcohol withdrawal.   "
137012|NCT01491334|"     The purpose of this study is to validate safety and effectiveness in assessment of the female     pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early     prolapse conditions and characterize the outcome of reconstructive surgery.   "
137013|NCT01491321|"     The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain     intensity, functional status and quality of life of patients with chronic low back pain.   "
137014|NCT01491308|"     The rationale for perioperative red blood cell (RBC) transfusion is based on the observation     that anemia is an independent risk factor for morbidity and mortality after cardiac     operations. However, transfusions have been associated with high rates of morbidity and     mortality in critically ill patients, and some recent studies have shown worse outcomes,     including increased occurrence of renal failure and infection, as well as respiratory,     cardiac, and neurological complications, in transfused compared with non transfused patients     after cardiac surgery. On the basis of past clinical observations, some authors have     suggested that hematocrit should be maintained at around 30% and hemoglobin concentration at     10 g/dL. Recently, however, this hemoglobin threshold has been reconsidered because of     recognized risks associated with transfusion and greater appreciation of the importance of     individual physiological responses to anemia. In a comparative trial of 428 patients     undergoing elective coronary artery bypass graft(CABG) surgery, Bracey et al reported that     reducing the hemoglobin trigger to 8 g/dL did not adversely affect patient outcomes and     resulted in lower costs. An important multicenter Canadian Study by Hebert et al that     included a large number of critically ill patients revealed that A restrictive strategy of     red-cell transfusion (hemoglobin concentration maintained between 7.0and 9.0g/dL) is at least     as effective as and possibly superior to a liberal transfusion (hemoglobin concentration     between 10 and 12 g/dL) strategy in critically ill patients, with the possible exception of     patients with acute myocardial infarction and unstable angina, in terms of reducing organ     dysfunction and mortality.      The investigators would like to determine whether a restrictive strategy of red-cell     transfusion and a liberal strategy produce equivalent results in orthopedic-oncology patients     undergoing surgery.   "
137015|NCT01491295|"     1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir          1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance          (LAM-R)        2. Long-term adefovir add-on therapy was effective for viral suppression. However, the          economic burden for such dual antiviral therapy is heavy because of infinite treatment.        3. Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated potent          antiviral efficacy in a subset of lamivudine experienced HBeAg-positive patients. TDF is          also superior to ADV in HBeAg-negative and HBeAg-positive treatment-naive patients.        4. Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by          LAM/ADV combination treatment in LAM-R CHB patients.   "
137016|NCT01491282|"     To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of     human brown adipose tissue.   "
137017|NCT01491269|"     The aim of the present study was to investigate if guided Internet-delivered     Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously     undergone a multidisciplinary treatment but still have residual problems.   "
137018|NCT01491256|"     Pre-treatment with statins decreased the incidence of cardiac enzyme increase after     percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI     myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on     post-procedural index of microcirculatory resistance (IMR) values that are introduced for     assessing the status of the microcirculation.   "
137019|NCT01491243|"     Patients who undergo urgent/emergency coronary angiography can not receive any preventive     treatment of contrast induced nephropathy. We tested the hypothesis that Neutrophil     gelatinase-associated lipocalin (NGAL), a new biomarker predictive for AKI, allows early and     effective treatment of contrast induced nephropathy in patients with urgent/emergency     coronary angiography   "
137034|NCT01491048|"     This study aims to objectively evaluate the implications of physiotherapeutic rehabilitation     in the Assistance Protocol of Total Hip Arthroplasty (THA), by assessing the motor     performance and testing the quality of life of patients undergoing THA surgery, to improve     rehabilitation strategies for this population.   "
137020|NCT01491230|"     Identifying the post-transplantation phase wherein neutrophils recover their ability to     release NETs could shed new light on the mechanism responsible for the increased     susceptibility to infection among these patients and aid in improving their prophylactic     antimicrobial treatment. Therefore, we aim to examine neutrophil extracellular traps (NETs)     formation, in relation to other neutrophil functions like chemotaxis, superoxide production,     hydrogen peroxide production, and the presence of myeloperoxidase, in pediatric patients     undergoing autologous and allogeneic hematopoietic stem cell transplantation (HSCT).   "
137021|NCT01491217|"     The main objectives of this study are to determine the maximum tolerated dose (MTD) and     recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of     Oraxol® in Phase II.   "
137022|NCT01491204|"     The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral     Paclitaxel. Eligible subjects of this study are patients with histologically or cytologically     confirmed malignant solid tumor refractory to standard therapy.      Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and     Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started on     day 29.      Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of     paclitaxel   "
137064|NCT01490658|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     compare repaglinide and metformin as co-administered tablets and as a combination tablet.   "
137065|NCT01490645|"     The purpose of the study is to analyse patient's acceptance and willingness to participate in     a Structured Care Program (SCP) over 12 months following hospital discharge after Acute     Coronary Syndrome (ACS) index event.   "
137026|NCT01491152|"     Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Up to day     the investigators have treated children diagnosed cerebral palsy with side-alternating whole     body vibration (System Galileo®) from the age of two years on. Considering verticalisation     (standing and walking) at about 12 months of age in a normal developing child the     investigators suggest the introduction of verticalisation with whole body vibration to a     child with CP at this early age in order to enhance motor development and participation.      In this pilot study the investigators will test the feasibility and the effect on motor     development of whole body vibration in children with CP from 12 months of age. The     investigators will investigate the effect of whole body vibration on motor performance,     independence in all day living situations, quality of life and contractures compared to a     control group.   "
137027|NCT01491139|"     The aim of this study is to find the safe dose and best dosing schedule of olaparib to give     in combination with cisplatin based chemoradiotherapy (CRT) in patients with locally advanced     head and neck cancer. The dose decided on in this part of the study will become the     recommended dose for the randomised Phase II trial.   "
137028|NCT01491126|"     The investigators study aim is to determine whether there is a any advantage in starting with     upper or lower endoscopy. The main study objective will be the amount of analgesia needed for     sustaining the examinee's comfort during the exams. Secondary endpoints will rate of     detection of significant pathologies, total time of procedure, examinee's tolerance, time to     recovery and examinee's satisfaction.   "
137029|NCT01491113|"     This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally     administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in     Japanese subjects with various degrees of impaired renal function.   "
137030|NCT01491100|"     Study assessing cognitive function and physical activity in people with relapsing remitting     multiple sclerosis.   "
137031|NCT01491087|"     The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at     2, 3, and 4 months of age in order to meet the regulatory requirements for the license     renewal as for any other product registered in China, and to generate additional clinical     data using the three-dose primary vaccination schedule in some other Chinese provinces.      Primary Objective        -  To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in          the study population.   "
137032|NCT01491074|"     Acute coronary syndromes (ACS) are still associated with high morbidity and mortality,     despite several improvements in their management. This may indicate that important pathogenic     mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms.      Based upon previous research, the investigators believe that providing a block in the     damaging inflammatory loop though short term inhibition of Interleukin-6 receptor signalling,     could be an attractive therapeutic target in ACS; and of particular interest in patients with     non-ST elevation myocardial infarction (NSTEMI), a disease often characterized by widespread     coronary inflammation with multiple unstable plaques.      The investigators hypothesize that a single administration of the anti-Interleukin 6 receptor     antagonist Tocilizumab, in patients with NSTEMI, may interrupt the self-perpetuating     inflammatory loops which could improve plaque stability, with potential secondary beneficial     effects on myocardial damage.      This will be investigated in a randomized, double blind, placebo-controlled study, including     a total of 120 patients.   "
137033|NCT01491061|"     It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7     days can significantly reduce procedural myocardial injury in elective percutaneous coronary     intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose     ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage     similarly to long-term pre-treatment with standard doses.   "
137035|NCT01491035|"     The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its     metabolites in connection with multiple oral dosing in child and adolescent patients with a     DSM-IV-TR diagnosis of Depressive or Anxiety Disorder   "
137036|NCT01491022|"     The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in     Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple     sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit     from this medication and have major improvements in gait after taking this medication.     However, this medication was never studied in Parkinson's disease. This study aims to learn     about possible benefits of AMPYRA in Parkinson's disease (PD).   "
137037|NCT01491009|"     The aim of the study was to compare the effects of remifentanil-dexmedetomidine and     remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia care     (MAC) patients undergoing cystoscopy.   "
137038|NCT01490996|"     Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable     colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX)     chemotherapy for up to 12 cycles(approximately 6 months) of treatment.      Primary measurements focus on safety and tolerability. These will be recorded in real-time     and report the number and severity of adverse events.      Secondary measurements will include efficacy, (measured by response rate with RECIST and     overall survival in months) supported by biomarker analysis.   "
137039|NCT01490983|"     This study is being conducted in a population of patients with chronic phase Chronic Myeloid     Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral     cancer drugs.   "
137040|NCT01490970|"     Sarcoma Database   "
137041|NCT01490957|"     Functional Assessment of Cancer Therapy - Bone Marrow Transplant   "
137042|NCT01490944|"     The study is a clinical trial to assess the effectiveness of Vitamin B12 supplementation     along with Iron Folic Acid (IFA) in combating anaemia. Adolescent anaemic girls will be     randomly divided into two groups.        -  Group 1: IFA weekly supplementation along with Information, Education, Communication          sessions        -  Group 2: IFA + Cyanocobalamin weekly supplementation along with Information, Education,          Communication sessions      Duration of supplementation: 6 months   "
137066|NCT01490632|"     This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib     in the treatment of participants with moderate to severe, chronic plaque psoriasis as     assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety     assessments.   "
137043|NCT01490931|"     The surgical placement of dental implants is presently a common procedure performed by oral     surgeons, periodontists, and general dentists. The surgery can be performed under local     anesthesia and involves the incision of soft tissue to expose the underlying bone,     preparation of the implant site using a specialized surgical drill, and.screwing the implant     into bone using a specialized headpiece. Dental implant patients experience postoperative     pain yet there are no studies in the literature which have evaluated the efficacy of     analgesics in this patient population. The current pilot study will evaluate the analgesic     effects and tolerability of a recently FDA-approved analgesic formulation of intranasal     ketorolac (SPRIX®) in 25 patients who have 1 - 3 dental implants surgically placed. Patients     will self administer the ketorolac nasal spray (one spray in each nostril, 31.5 mg total     dose) when their postoperative pain reaches at least a moderate severity. Pain intensity and     pain relief scores will then be recorded every 20 minutes for the first hour, at 1.5 and 2     hours and then hourly through 6 hours on a validated analgesic diary. Side effects will be     recorded when and if they occur. Patients will then transition to a multi-dose phase where     they will be allowed to dose with ketorolac as indicated in the package insert (up to 4 times     per day for 5 days). Patients will record the time of each dose, a daily assessment of     overall efficacy and side effects, and the use of any rescue medication (acetaminophen 650     mg) on a take home diary.   "
137044|NCT01490918|"     Primary objective To evaluate the efficacy of Acarbose added on top of Metformin and     Sitagliptin that were combinedly administered to subjects with type-II diabetes, along with     placebos.      Secondary objectives        1. To compare a Metformin-Sitagliptin combination and a Sitagliptin-Acarbose combination in          efficacy        2. To evaluate the 6-month efficacy of Acarbose added on top of the Metformin-Sitagliptin          combination   "
137045|NCT01490905|"     This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug     (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and     tolerability of Theramine alone in patients with chronic back pain in comparison to the     NSAID, Ibuprofen, and the co-administration of Ibuprofen with Theramine.   "
137046|NCT01490892|"     This is a non-randomized trial of 450 women with a breast abnormality, who are scheduled for     a breast biopsy of this abnormality. The study will be conducted at two clinical sites. The     primary objective of this trial is:      To evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging     (HI) can improve the characterization of benign and malignant breast masses (independently or     in combination with other imaging modes) compared to x-ray mammography, fundamental grayscale     ultrasound (US) or power Doppler imaging (PDI).      The secondary aim of this trial is:      To compare quantitative (bifurcations & vessel length) and semi-quantitative (blood pool &     parametric imaging) measures of the vascular morphology of breast lesions determined by     pathology and by SHI.   "
137047|NCT01490879|"     This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The     study is being done to determine if Nexagon® plus standard of care is more effective than     placebo plus standard of care. Standard of care will include debridement of the ulcer,     standardized dressings and standardized off-loading using a Removable Cast Walker.   "
137048|NCT01490866|"     This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent     maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients     with mCRC.   "
137108|NCT01490073|"     Increasing ease of access of long-acting birth control methods, like intrauterine devices     (IUDs), is an important way to reduce the risk of unintended pregnancy. Unfortunately, fear     of IUD insertion in women who have not had children is common among health care providers and     women alike, and this limits IUD use. To increase acceptance of this highly effective birth     control method, there is a need to explore new, low cost, and easily applied methods to     improve the insertion experience. This is a pilot study to evaluate the effectiveness and     acceptability of nitroglycerin ointment applied vaginally to improve the IUD insertion     experience for both patient and provider. The investigators hypothesis is that nitroglycerin     ointment will decrease the pain associated with IUD insertion.   "
137049|NCT01490853|"     Objectives      This is an observational study aimed at updating the overall survival (OS), the progression     free survival (PFS) to accelerated-blastic (AB) phase and the complete cytogenetic response     (CCgR) duration of the CML patients who between 1986 and 2001 were treated with an IFN based     therapy (either alone or in combination) and who obtained a CCgR. It also aims at analysing     the clinical and biological features of this selected cohort of patients with persisting CCgR     after treatment with IFN.      Study design This study is an observational retrospective multicenter study.      Assessment and Follow-up Patients' demographic data and retrospective collection of CML     cytogenetic and molecular data will be reported in the Assessment and Follow-up FORM.      In this FORM the events related to therapy, disease and survival will also be reported.      Duration of the study:      The recruitment period is estimated in approximately 2 years.   "
137050|NCT01490840|"     This study evaluated the effect of an individualized web-based physical training in     fingolimod -treated patients.   "
137051|NCT01490827|"     This post-market surveillance study is conducted in the European Economic Area where Argus II     has been CE certified for use in outer retinal degeneration patients. This study is being     conducted to monitor the use of Argus II in a larger population than available within     pre-market approval studies. Safety data will be monitored to ensure continued acceptability     of risks to study participants, and an attempt will be made to include all eligible and     willing participants implanted with Argus II. Measures of visual function that may contribute     to device improvements will also be gathered and evaluated.   "
137052|NCT01490814|"     Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon     catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with     paroxysmal atrial fibrillation.   "
137053|NCT01490801|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients     with Epstein-Barr virus positive Hodgkin lymphoma.   "
142787|NCT01415505|"     The purpose of this study is to evaluate the safety and tolerability of nebivolol and     valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential     hypertension.   "
137054|NCT01490788|"     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for     bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102     2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision     and decreased potential for morning grogginess) and to compare the bio-availability of     TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.   "
137055|NCT01490775|"     This study is being conducted in a population of patients with chronic phase Chronic Myeloid     Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral     cancer drugs.   "
137056|NCT01490762|"     This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and     effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.   "
137057|NCT01490749|"     The purpose of this study is to test the drug RAD001 in combination with another chemotherapy     drug, Carboplatin, as well as radiation therapy in the treatment of esophageal cancer.     Because RAD001 has not been used in this combination before, it is not clear which dose will     be best when used in combination.      The standard of care for patients who have esophageal cancer that has not moved to other     areas of the body (non-metastatic) includes a combination of chemotherapy, radiation therapy     and possibly surgery. If the patient chooses to participate in this study, the patient will     receive chemotherapy and radiation therapy. The patient will possibly also have surgery to     have the cancer removed. This decision will be made by the treating physicians. All of the     chemotherapy the patient will receive on the study is considered standard chemotherapy for     esophagus cancer. The investigators do not know as of yet if the drug called RAD001 will help     improve the treatment for patients with this disease. RAD001 is a pill that has been used in     many other types of cancer and has been proven to be effective in other cancers such as     kidney cancer.   "
137058|NCT01490736|"     The purpose of this study is to determine the safety of photodynamic therapy (PDT) with     lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.   "
137059|NCT01490723|"     The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan)     to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine),     followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of     this combination will also be studied.      Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is     designed to attach to lymphoma cells and destroy the cells using a radioactive particle that     is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the     radioactive particle that is attached to it does not kill lymphoma cells. The radioactive     particle makes the drug able to be seen inside your body. It is being used in this study to     predict how fast the study drug will travel in the body and how long the drug stays in the     body.      Rituximab is designed to attach to lymphoma cells, which may cause them to die.      Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.      Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may     increase the likelihood of the cells dying.   "
137060|NCT01490710|"     Despite spectacular advances since the 90s mechanical ventilation used in intensive care     units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung     parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a     significant morbidity and mortality.      NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous     support, proportionate to patient's respiratory efforts. More physiological, this mode     would decline its efficacy on patient hemodynamic response. However, to date, no study has     focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study,     which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.   "
137109|NCT01490060|"     The goal of this clinical research study is to learn how different doses of fosaprepitant may     effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to     learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may     be caused by chemotherapy. The safety of this drug will also be studied.      Fosaprepitant is designed to block the natural substance in the brain that causes nausea and     vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.   "
137061|NCT01490697|"     Despite substantial therapeutic advances, Posttraumatic Stress Disorder (PTSD) remains     difficult to treat. One promising new area of research is in post-reactivation pharmacologic     intervention, which is based upon the concept of blockade of memory reconsolidation. Recent     animal research suggests that reactivation (retrieval) of a stored memory can return it to a     labile (alterable) state from which it must be restabilized in order to persist. This process     is called reconsolidation, and various drugs have been found to block it in animals. This     blockade may lead to a weakening of the original memory trace.      The aim of this study is to pilot the effect of mifepristone on physiologic responding during     traumatic imagery. Although mifepristone is widely and safely used to cause a medical     abortion, it is also a powerful stress hormone receptor blocker. These stress hormones,     called glucocorticoids, may enhance memory (re)consolidation. Indeed, a recent study in     animals reported that mifepristone blocked reconsolidation of context-conditioned fear in     rats.      Reconsolidation blockade is a two-stage process. First, the memory must be destabilized by     recalling it. Second, reconsolidation of the memory must be blocked by a drug. Memory traces     formed under stressful conditions may resist destabilization and thus are inaccessible to     reconsolidation blockers. However, when a reconsolidation blocker was paired with     d-cycloserine (DCS) in animals that had been trained under stressful conditions,     reconsolidation blockade became successful. These results suggest that DCS promotes the     destabilization of resistant memory traces. The traumatic memories of individuals with PTSD     may be particularly resistant to destabilization. Therefore, this study will compare     mifepristone paired with DCS to placebo controls.      The same script-driven traumatic imagery method validated in previous studies of propranolol     in this lab will be used. Briefly, subjects with PTSD will describe their traumatic event     during a script preparation session, which will reactivate the memory. They will then receive     a) mifepristone and DCS or b) placebo. A week later, they will engage in script-driven mental     imagery of their traumatic event while physiologic responses (heart rate, sweating, etc) are     measured. This is a pilot study so there are no formal hypotheses. The aim is to estimate     effect sizes for mifepristone and to compare them with effect sizes for propranolol from this     lab's previous work.   "
137062|NCT01490684|"     Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in     Saudi Arabia is not well studied. This observational study objectives include to determine     the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill     patients in Saudi Arabia.   "
137063|NCT01490671|"     Preliminary research has shown that a vaginal gel containing the antiretroviral (ARV) drug     tenofovir may reduce the risk of HIV infection in women when used near the time of sexual     intercourse. This study will evaluate the safety of 1% tenofovir gel in HIV-uninfected     pregnant women and their newborns when the gel is used once a day for a period of 28 days at     a designated time during pregnancy.   "
137067|NCT01490619|"     Adolescents with type 1 diabetes are at increased risk for depressive symptoms, poor coping     and problem-solving skills, poor regimen adherence, and negative diabetes-specific health     outcomes. Although a handful of psychological interventions targeting adolescents' poor     behavioral and emotional functioning demonstrate beneficial effects on disease management and     outcomes, no prevention programs exist that equip adolescents with behavioral skills and     cognitive strategies necessary to reduce these risks. Therefore, the proposed research will     test whether a diabetes-specific adaptation of a resilience promoting, depression-prevention     intervention for adolescents with type 1 diabetes will reduce both the risk of poor     psychological functioning and the risk of negative health outcomes over time.   "
137068|NCT01490606|"     A. Background.      Patients with osteoarthritis (OA) of the knee, suffer from a combination of pain, stiffness,     joint instability, swelling and muscles weakness. This leads to decrease in quality of life,     Active Daily living (ADL) and increase of medical services consumption in the community. OA     of the knee, Is one of the world's common musculoskeletal disorder (18% among women and 10%     among men). 80% of patients with OA of the knee suffer from decrease in mobility and 20% of     them suffer an inability to perform everyday activities.      Physical therapy training includes exercises for OA patients (Mild to Severe degree) is the     cornerstone of non medicinal treatment. This training aimed to pain reduction, improved     functioning and participation in family and working social life. Physical training with     exercises can enhance physical capabilities such as: muscular strength, range of motion,     balance, proprioception and cardiovascular performance. Other benefits are improving     mobility, reducing risk of falls and body weight and improvement in psychological condition.      B. Purpose      The purpose of this research is to check the effectiveness of treatment in the framework of     knee Osteoarthritis project compared to conventional Physical therapy in physical     functioning, pain and quality of life scales, among patients over the age of 60 who suffer     from OA of the knee .      C. Research method      A comparative non blinded, clinical trial will be conducted. This research will include 60     independent patients divided into equal groups: Intervention group will be trained in knee     Osteoarthritis project (in which patients receive 6 individual treatments and 6 Group     treatments). Control group will be treated with conventional physical therapy, which includes     12 individual treatments. Effect of the treatment will be evaluated by: 1. WOMAC     questionnaire- used to evaluate function and pain. 2. EQ-5D questionnaire for evaluating the     quality of life. 3. Time up and go test- a Common functional test. This Questionnaires and     test will be Performed before and after the study.      D. Study hypothesis      Physical therapy treatment within the framework of knee Osteoarthritis project is favor     than the treatment of the conventional Physical therapy. Therefore the investigators expect     much improvement in terms of pain, physical functioning and quality of life among     intervention group compared to control groups.   "
137069|NCT01490593|"     The purpose of this study is to establish an eye injury registry to assess the mechanisms and     outcomes of significant eye injuries occurring in Canada. The epidemiologic data will     determine where public health strategies should be directed to prevent future eye injuries.   "
137070|NCT01490580|"     Multicenter double blind randomized controlled trial comparing atropine+propofol vs     atropine+atracurium+sufentanil as a premedication prior to endotracheal intubation of the     neonate.      Primary outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes:     number of attempts, duration of the procedure, changes in physiologic parameters, short- and     long-term neurodevelopmental outcome.      Hypothesis: atropine + propofol compared to atropine+atracurium+sufentanil will     significantly reduce the frequency of severe hypoxemia.   "
137071|NCT01490567|"     The objective of the study was to study the effects of donepezil on cognition in patients     with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled     trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with     schizophrenia.   "
137072|NCT01490554|"     The purpose of this study is to evaluate the presence of skin changes after grafting of     autologous fibroblasts by means of biophysical, histological, immunohistological, gene     expression, glycosaminoglycan, and sensitivity analyses.   "
137073|NCT01490541|"     The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a     recommendation for Thai population.      Objective:      To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM)     patient in order to propose the appropriate recommendation for Thai people.      Research Design:      Single center, retrospective-cohort study.   "
137074|NCT01490528|"     There is little data published on the long term durability of infliximab in pediatric     patients. In particular a focus on durable remission, frequency of dose/frequency change and     switch within class. Moreover 10 years of safety experience is rarely reported in children.      The overall objective is to evaluate the persistence of infliximab as well as dosing     strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab     Regarding persistence of infliximab the investigators will be focusing on the proportion of     patients who continue to have a durable response or remission to infliximab.      The investigators will be assessing this by measuring the frequency of dose escalation,     proportion of patients needing frequency change and proportion of patients switched to     adalimumab or certolizumab.      Safety outcomes will focus on frequency of malignancies, infections and immunogenecity   "
137075|NCT01490515|"     Metabolomics was recently introduced in human IVF for non-invasive identification of viable     embryos with the highest developmental competence. The investigators intended to investigate     if embryo assessment using non-invasive metabolomic profiling leads to increased implantation     rates compared to routine morphology evaluation alone.   "
137076|NCT01490502|"     Low vitamin D levels have been shown to increase a person's risk of developing multiple     sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk of     having attacks. However, it is not known if giving supplemental vitamin D to those with MS     reduces the risk of attacks, and some research suggests that vitamin D could even be harmful     to people with MS.      In this clinical trial, patients with relapsing-remitting MS will receive high-dose or     low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate.     Patients will be evaluated for two years, and the effect of high-dose vitamin D     supplementation on the rate of MS attacks and on the number of new lesions and change in     brain volume on MRI will be determined. Establishing this association will have major     implications for the treatment of individuals with MS throughout the world.   "
137077|NCT01490489|"     The purpose of this study is to assess the potential prognostic value of seric concentrations     of EG-VEGF for Pre-eclampsia and/or intrauterine growth restriction and will allow checking     whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be proposed as prognostic     marker for preeclampsia.   "
137078|NCT01490476|"     The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth     of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients.   "
137079|NCT01490463|"     The purpose of this study is to determine the incidence and impact of brain lesions in MRI     after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological     outcome of patients.   "
137081|NCT01490437|"     Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single     agent as first-line and second-line treatment for advanced urothelial carcinoma. The response     rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is     one the most active chemotherapeutic agents in urothelial cancer, frequently used as     combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate,     vinblastine, adriamycin, and cisplatin).      Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung     cancer with highly favorable toxicity profile.      This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced     urothelial carcinoma.   "
137082|NCT01490424|"     Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor     expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a     critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can     protect against sepsis in mice. This study was designed to investigate whether TREM-1 genomic     variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with     TREM-1 gene of four exons by PCR sequencing. When analyzing the results of sequencing, we     found two gene polymorphisms located in exon-2 and exon-4, respectively. Compare with the     NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous     variation rs2234237（Ser25Thr）, the other one located in exon-4 is synonymous variation     rs2234246. Two common polymorphisms (rs2234237,rs2234246) within the TREM-1 gene were     detected in 80 patients with severe sepsis and in 80 healthy control subjects. This study was     explored that whether or not polymorphisms detected within the TREM-1 gene may play a major     role in the predisposition to prognosis of sepsis in a Chinese Han cohort.   "
137083|NCT01490411|"     The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic     Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and     also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is a     vaccine that works by exposing your immune system to something that resembles birch. This     vaccine may help to lessen your allergy symptoms during the natural birch season.   "
137084|NCT01490398|"     In ASCOT study, lipid lowering with a statin provided additional beneficial effects in     hypertensive patients with average levels of serum total cholesterol. However, the underlying     mechanism of statins to improve clinical outcomes in hypertension is unclear and the effect     of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients.     Therefore, it is clinically important and timely project to measure CFR non-invasively using     echocardiography and to elucidate the mechanism of clinical benefits of statins in     hypertensive patients with cardiovascular risk. The investigators try to evaluate the effect     of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin,     and to correlate CFR with LDL-cholesterol and CRP.   "
137085|NCT01490385|"     LED Phototherapy will increase the velocity of Orthodontic tooth movement.   "
137110|NCT01490047|"     Assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of recombinant human     tumor necrosis factor-α (rhTNF-α) when given as a single dose intravenously and in     combination with liposomal doxorubicin in human subjects   "
137223|NCT01488578|"     The objective of this surveillance is to collect information about 1) adverse drug reaction     not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of     adverse drug reactions in this surveillance, and 3) factors considered to affect the safety     and/or efficacy of this drug.   "
137086|NCT01490372|"     Gestational Diabetes Mellitus (GDM) has long been known as leading to macrosomias, neonatal     hypoglycemias and other complications which are treatable and preventable. Nowadays, GDM is     recognized as an entity with long-term serious sequels to the mother (GDM is considered a     forerunner of type 2 diabetes) and her offspring. Indeed, according to the programming     hypothesis, GDM sets the stage for metabolic syndrome, obesity, type 2 diabetes and     hypertension. However, these cross-sectional studies failed to control for maternal disease     history and genetic background although heredity is a major epidemiology risk factor of type     2 diabetes. Also, studies usually refer to traditional markers such as BMI, blood pressure,     lipids profile and oral glucose tolerance test (OGTT); none explored inflammatory biomarkers     and adipokines in-depth, despite the possible link between their presence and the development     of metabolic and cardiovascular diseases in GDM offsprings.      Exclusion of genetic confounding factors will help establish the role of GDM as an     independent marker of cardiometabolic risk in GDM offspring. It is highly relevant to     identify GDM as a risk factor for cardiometabolic diseases, given the worldwide obesity     epidemic, the alarming prevalence increase of GDM and its serious sequels to both mother and     offspring.   "
137087|NCT01490359|"     Sub-Saharan Africa has about 10% of the world's population, but was home to more than 60% of     all people living with HIV in 2003. South Africa continues to have the largest number of     people living with HIV in the world, and as in other parts of sub-Saharan Africa,     heterosexual exposure is the primary HIV transmission category. Worldwide, efforts to stem     the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited     statistics indicate that about half of all people living with HIV are women. The strategies     typically offered to address the impact of HIV on women are interventions with women.      To be sure, there is an alternative approach to addressing women's risk of heterosexual     transmission of HIV, one that would be an important complement to the predominant approach:     namely, focusing on men. By reducing men's sexual risk behavior, it should be possible to     reduce rates of HIV in both men and women. Men's rates would decline because they are the     recipients of the intervention; women's rates would decline because they have sex with men.     Interventions aimed at men could take into account the power that men have in sexual     decision-making and risk taking. However, whether one considers the US literature or the     international literature, few randomized controlled trials of HIV/STD risk-reduction     interventions have focused on heterosexual men.      Accordingly, the purpose of this research is to develop and test the efficacy of an     intervention to curb HIV/STD risk-associated behavior in South African men who have sex with     women. A cluster-randomized control trial design will be used to reduce the potential for     contamination between treatment arms that would be present if individuals were randomized. An     attention control group will be used to control for Hawthorne effects, special attention, and     group interaction. Matched pairs of neighborhoods in Black townships in Eastern Cape     Province, South Africa similar on key characteristics will be created, 22 pairs will be     randomly selected, and men will be recruited. One neighborhood in each pair will be randomly     assigned to each of the 2 study arms.      The primary hypothesis is that men who receive a culturally appropriate theory-based HIV/STD     risk-reduction intervention will be more likely to report consistently using condoms during     vaginal intercourse in the 12-month post intervention period than will men who receive an     attention-control intervention, controlling for baseline condom use.   "
137088|NCT01490346|"     The aim of this study is to find out why HIV continues to make copies in people taking HIV     drugs. The investigators want to know if the medications most people use to treat HIV get     into the lymphatic tissue where HIV persists.   "
142842|NCT01414790|"     The aim of the study was to explore whether human acellular dermal matrix (ADM) implantation     could prevent infraauricular depressed deformities and Frey's syndrome following total     parotidectomy.   "
137089|NCT01490333|"     Cardiovascular disease (CVD) and diabetes occur commonly among Native Americans (NA), and are     leading causes of death among northern US NAs. Moreover, low vitamin D status occurs commonly     in this same population. An increasing amount of evidence indicates a correlation between low     vitamin D status and CVD and diabetes by contributing to a heightened pro-inflammatory     environment within the endothelial lining of blood vessels leading to atherosclerotic     disease, and an impaired sensitivity to insulin leading to diabetes. Our fundamental     hypothesis is that low vitamin D status is a risk factor for CVD by causing a proinflammatory     milieu, thereby leading to endothelial dysfunction. Additionally, the investigators     hypothesize that vitamin D supplementation will reduce inflammation, thereby restoring     endothelial function and ultimately reducing CVD risk.   "
137090|NCT01490320|"     The American Academy of Pediatrics recommends that parents receive anticipatory guidance     about violence prevention as part of the routine well child visit. Educational resources are     needed to help physicians routinely provide these important anticipatory guidance messages.     In this study, consecutive parents will be exposed to routine anticipatory guidance messages     before the well child visit with the physician. After the clinic visit, parents will be     invited to participate in a research study to determine if they plan any changes at home. The     key research question of this study is:      Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids     brochure, entitled, Pulling the Plug on TV Violence, help parents develop plans to     decreases their children's exposure to violence in the media (e.g. less media time, no TV in     the bedroom)?   "
137091|NCT01490307|"     The goal of this project is to empirically refine and improve a comprehensive family-centered     prevention strategy for reducing and preventing adolescent substance use and other problem     behaviors. This project builds on 15 years of programmatic research underlying the     development of the Family Check-up model (FCU), originally referred to as the Adolescent     Transitions Program (ATP; Dishion & Kavanagh, 2003), but later expanded as a general approach     to mental health treatment for children from ages 2 through 17 (Dishion & Stormshak, 2007).     The FCU model is a multilevel, family-centered strategy delivered within the context of a     public school setting that comprehensively links universal, selected, and indicated family     interventions. Previous research and the investigators' practical experience working in     school settings indicate that the intervention strategy needs improvement in 3 critical areas     to build on previous significant effects and to enhance the potential for future     dissemination and large-scale implementation:(a) improve the feasibility of both the     universal level and the indicated level of the intervention by broadening the intervention     components and systematically embedding these components into the current behavioral support     systems in the schools; (b) address the transition from middle school to high school, with     special attention to academic engagement and reduction of deviant peer clustering; and (c)     explicitly incorporate principals of successful interventions with families and young     adolescents of diverse ethnic groups into both the universal and indicated models. An     additional general goal of this study is to develop, test, and refine a set of research-based     instruments that facilitate evaluation, training, implementation, and monitoring of     intervention fidelity to maximize the potential success of implementation and large-scale     dissemination.      Participants include 593 youth and their families recruited from the 6th grade in three     public middle schools in Portland, OR. Families were randomly assigned to receive either the     FCU intervention model or treatment as usual. Assessments were collected for 5 years through     the 10th grade. High school transition planning and intensive intervention efforts occurred     in Grades 7-9.      The investigators tested the hypothesis that the FCU intervention will reduce the growth of     problem behavior and substance use through the enhancement of family management and parent     involvement in school.   "
137092|NCT01490294|"     The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac     Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT     examination in terms of diagnostic quality.      For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg     body weight are administered. A study participant receives the respective dose twice i.e. at     rest and at stress using Adenosine (which puts circulation into a state of stress similar to     that of physical exercise). The time between both injections is 10-15 min.      The total imaging time is about 45 min.   "
137093|NCT01490281|"     Background The Al-Andalus physical activity intervention study is a randomised control trial     to investigate the effectiveness of a land- and water-based exercise intervention for     reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness     and pain-related measures, body composition, functional capacity, physical activity and     sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive     function (secondary outcomes) in women with fibromyalgia.      Methods One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited     from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will     be randomly assigned to a usual care (control) group (n=60), a water-based exercise     intervention group (n=60) or a land-based exercise intervention group (n=60). Participants in     the usual care group will receive general physical activity guidelines and participants     allocated in the intervention groups will attend three non-consecutive training sessions (60     minutes each) per week during 24 weeks. Both exercise interventions will consist of aerobic,     muscular strength and flexibility exercises.      Discussion The investigators study attempts to reduce the impact of fibromyalgia and improve     patients' health status by implementing two types of exercise interventions. Results from     this study will help to assess the efficacy of exercise interventions for the treatment of     fibromyalgia. If the interventions would be effective, this study will provide low-cost and     feasible alternatives for health professionals in the management of fibromyalgia. Results     from the Al-Andalus physical activity intervention will help to better understand the     potential of regular physical activity for improving the well-being of women with     fibromyalgia.   "
137094|NCT01490268|"     The purpose of this study is to determine generation of a target controlled infusion model     for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned     open heart surgery, during which the strong analgesic, sufentanil, was used.   "
137095|NCT01490255|"     No previous study has assessed the potential of ranolazine to interfere with levels of     platelet reactivity in patients with coronary artery disease who are treated with dual     antiplatelet therapy.      Aim of this study is to compare the pharmacodynamic effects of maintenance doses of     ranolazine versus amlodipine on platelet reactivity in patients with coronary artery disease     who are treated with dual antiplatelet therapy.   "
137096|NCT01490229|"     Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals     (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will     compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in     statin-intolerant patients treated with percutaneous coronary intervention.   "
137097|NCT01490216|"     The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability,     plus reduction in cocaine use and craving.   "
137101|NCT01490164|"     Corrective surgery for scoliosis can result in prolonged operating room time and significant     blood loss. The investigators goal is to determine what the transfusion requirements are for     young adults undergoing spinal surgery for scoliosis and what other intra-operative factors     influence the amount of blood and blood products used. The investigators will used the     information obtained to improve the management of patients undergoing corrective surgery for     scoliosis.   "
137102|NCT01490151|"     The purpose of this study is to evaluate a treat-to-range automated insulin management system     using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in     individuals with type 1 diabetes.   "
137103|NCT01490138|"     Invasive fungal infection (IFI) is a disease usually occurred in the patients with     compromised immune condition, such as acute leukemia, allogeneic stem cell transplantation or     long term immune suppression treatment with the incidence increasing over last decades. Given     the introduction of numerous anti-fungal agents and great advance has been made in recent     years, IFI is still a dangerous disease with high mortality.      Early diagnosis of IFI is still a problem challenging the physicians. Serum tests of     β-D-Glucan are introduced to the diagnosis of IFI, which have the advantage of easy     application. However, the value of this test in the monitoring of antifungal treatment     remains unclear.      The investigators perform this study to evaluate the correlation of the serum test results of     β-D-Glucan test with the treatment response during the anti-fungal treatment, and hope to see     that the results of serial serum tests are good predictive markers for treatment response.   "
137104|NCT01490125|"     This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe     Chronic Obstructive Pulmonary Disease (COPD) patients.   "
137105|NCT01490112|"     This study is conducted in Asia. The aim of this study is to observe the safety and efficacy     of insulin aspart (NovoRapid®) administered via vial and three different devices.   "
137106|NCT01490099|"     This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence     between insulin detemir produced by the NN729 process and by the current process in healthy     subjects.   "
137107|NCT01490086|"     The objective of this study is to evaluate the efficacy and safety of RP5063 relative to     placebo for the treatment of schizophrenia or schizoaffective disorder.   "
137132|NCT01489761|"     This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting     stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime     or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.   "
137111|NCT01490034|"     Due to the rising incidence of obesity, much emphasis has been placed on identifying     mechanisms of increased energy intake. At this point, the mechanisms responsible for the     recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive     influences, such as cognitive factors, may play a larger role in creating an energy surplus     than previously thought. Expectations about the satiating effect of a food may override the     post-ingestive influences in dictating further consumption. In addition, obese individuals     may exhibit a decreased compensatory response to foods as compared to lean individuals.      Understanding the effects of energy content, food form, and learning on satiation, satiety,     and energy intake will allow for a greater understanding of the mechanisms of energy     imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive     effects. By utilizing foods with similar sensory properties, the acquired knowledge derived     from ingesting these foods can be monitored by analyzing subsequent intake at the same meal     and at subsequent eating occurrences. It is hypothesized that the liquid food form will     elicit weaker dietary compensation; that is, energy intake at other eating events will not be     adjusted to compensate for that food. In addition, it is posited that the lower energy food     will cause lower compensation postprandially. By having participants consume the same test     food daily over a two week learning period, it is thought that they will show improved     dietary compensation when the initial testing is repeated due to learned associations between     food properties and metabolism.   "
137112|NCT01490021|"     Episodic and working memory processes are the most affected cognitive domains in Alzheimer's     Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic     Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing virtual     and transient lesions, mimicking those observed in MCI. It has proven repeatedly its     capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging     data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability     of TMS effects over time remains to be investigated. If proven to be a stable interfering     challenge, TMS could be used to investigate the potential restoring effect of new medication     in AD.      The study is the pilot study of a larger clinical trial which aims to prove the utility of     rTMS as a potential model for prediction of clinical efficacy using a combination of     cognitive and neuroimaging endpoints.   "
137113|NCT01490008|"     Investigation of systemic catechin exposure following topically administered Veregen® 15%     ointment in patients with external genital and perianal warts and following oral intake of a     standardized green tea beverage in healthy subjects.      Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin     exposure following dermal administration in the patient group will only be calculated if     sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations     to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations.      If applicable, a safety margin for ointment use might need to be established with respect to     intolerable systemic exposures of catechins following application of Veregen® ointment.      In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg     three times daily: in the morning, at midday, and in the evening on the defined anogenital     administration area (total dose of 750 mg/d) for one week .      In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea     beverage (Lipton® Green Limone distributed by PepsiCo Deutschland GmbH, Neu-Isenburg,     Germany), three times daily in the morning, at midday, and in the evening (total dose of 1500     mL/d) for one week.      Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24     hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first     dosing).      To avoid any influence on overall systemic catechin exposure deriving from any other source     than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and     healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages     known to containing catechins (a list of all prohibited and allowed foods and beverages will     be provided to all subjects).      For concomitant medication, only paracetamol and oral contraceptives are allowed.   "
137114|NCT01489995|"     A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl     pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to 1     of 5 treatment sequences and will receive each treatment over the course of 5 weekly periods.   "
137115|NCT01489982|"     More than half of patients with Parkinson's have troubles with insomnia. There are several     treatment options for insomnia that have been studied in the general population - however,     the investigators don't know if these treatments work for patients with Parkinson's. It is     possible that people with Parkinson's may have different treatment responses.      The goal of this project is to test in a pilot study the tolerability and effectiveness of     pharmacologic and non-pharmacologic treatments to improve insomnia in patients with     Parkinson's disease. Each participant in this study will be wearing a wrist actigrapch and     fill out the sleep diary. Three main treatment strategies will be tested: Placebo Light     therapy, Cognitive behavioural therapy and active light therapy, and insomnia medications.     The treatment that each person will receive first will be chosen randomly. If the first     therapy has not been effective, participant may choose to re-enrol in the trial with one of     the remaining two therapies.   "
137116|NCT01489969|"     This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo     controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to     receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to     assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia     patients aged 18-80 years, following the first two nights (immediate effect) and at the end     of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency     to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of     treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The     secondary endpoints are number of awakenings after sleep onset and the duration of wake after     sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study;     mean of two consecutive nights recordings).   "
137117|NCT01489956|"     The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH)     and to determine if Immucothel by itself is strong enough to trigger the immune response. If     not, Immucothel will be tested in combination with an adjuvant to determine if an adequate     immune response can be seen.   "
137118|NCT01489943|"     The purpose of this study is to test the effects of study drug (GSK1605786) on the blood     levels of multiple commonly used drugs that are given to measure how your liver breaks down     the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and     rosuvastatin which will determine the effect of GSK1605786 on how the body breaks down     (metabolizes) these commonly-used drugs. Blood samples for pharmacokinetic analysis of     GSK1605786, and two metabolites, [GSK2635622 (CCX062) and GSK2656694 (CCX304)] and four probe     substrates will be collected over a 24-hour period after administration. Safety will be     assessed by the measurement of vital signs, cardiac monitoring, collection of adverse event     assessments and laboratory tests.   "
137119|NCT01489930|"     Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This     are-related decline in skeletal muscle mass and skeletal muscle strength is a major     underlying factor contributing to many of the metabolic disorders and frailty of the     investigators rapidly expanding aging population. Endurance (aerobic) and resistance exercise     training programs have been shown to effectively reverse the age-related decline in metabolic     and contractile muscle functions. The investigators will measure synthesis rates of     individual muscle proteins in 36 each of young (18-30 yrs) and 36 older (> 65 yrs) people to     determine their response to 8 weeks each of endurance, resistance, combined endurance and     resistance training, or placebo exercise training.      Hypotheses.        1. to measure fractional synthesis rates of multiple muscle proteins and identify those          that are enhanced by an endurance exercise program        2. to determine whether changes in protein synthesis in response to endurance exercise          programs are dependent on age        3. to measure fractional muscle synthesis rates of multiple muscle proteins and to identify          those that are enhanced by a resistance exercise program        4. to determine whether changes in protein synthesis in response to resistance exercise          programs are dependent on age   "
137120|NCT01489917|"     The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary     angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori     heparin use in patients undergoing transradial coronary angiography to a strategy of     provisional heparin administration only if patent hemostasis is not achievable.   "
137121|NCT01489904|"     The purpose of this study is to evaluate the safety and efficacy of botulinum toxin-A in     salivary glands as a treatment for decrease drooling in patients with cerebral palsy and     evaluate the long-term effects and tolerance . To assess whether patients with cerebral palsy     have hypersalivation comparing with patients without treatment and healthy volunteers and if     botulinum toxin may reduce the volume of drooling without altering the swallowing function.   "
137122|NCT01489891|"     The purpose of this study is to determine the efficacy of application of the anaesthesia     topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in     therms of dosage and side effect´s reduction overall.   "
137123|NCT01489878|"     In this prospective, observational, multicentric open study, the investigators will compare     the acquisition rates of methicillin-resistant staphylococci (coagulase-negative     staphylococci and Staphylococcus aureus) nasal carriage in community patients receiving an     ambulatory antibiotic treatment by either a β-lactam (amoxicillin-clavulanate or penicillins     M), a macrolide, a synergistin or a fluoroquinolone.   "
137124|NCT01489865|"     People are being asked to participate in this study who have metastatic pancreatic cancer     (cancer that has spread to other parts of the body).      The purpose of this study is to test the efficacy (effectiveness) of a new combination of     drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with     metastatic pancreatic cancer.      ABT-888 inhibits an enzyme called PARP which helps to fix damaged DNA. By inhibiting this     enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and     will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.   "
137125|NCT01489852|"     The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of     2 additional oocytes in GnRH antagonist protocol.   "
137126|NCT01489839|"     The primary purpose of the study will be to look for biological biomarkers to determine which     people with gum disease will have a worsening of the disease. A second objective of this     study will be to look at the effects of periodontal treatment on the levels of the biomarkers     that are identified.   "
137127|NCT01489826|"     This study is a trial of Dexanabinol in patients with advanced solid tumours. The purposes of     this protocol are to study different doses of the study drug to determine the maximum safe     dose and to further understand the safety of the study drug; to understand what the body does     to the study drug; to understand what the study drug does to the body and to measure any     reduction in size of patients' cancer tumour(s).      Dexanabinol is a synthetic cannabinoid derivative with reduced psychotropic potential which     was initially investigated as a neuroprotective agent. Because of its method of action     however it is thought that it may have the effect of destroying cancer cells by reducing the     level of control on networks that prevent cancer cells dying.   "
137128|NCT01489813|"     Patients with non-invasive bladder cancer are often treated with intravesical therapy in     order to prevent the recurrence of bladder cancer. Intravesical therapy can cause many lower     urinary tract symptoms, which can limit the dose of therapy and therefore efficacy of     treatment. There have been a number of studies that suggest a chemical found in soy beans may     be able to help with these side effects. This chemical is called genistein and can be     extracted and given to study subjects in pill form. In this study, the investigators would     like to have patients placed into two different groups. One group would take genistein and     the other group would take a placebo, a sugar pill that looks like the genistein pill. In     doing this study the investigators hope to explore the findings from other studies to see if     lower urinary tract symptoms are reduced and to see if recurrence rates for patients are     affected by genistein. The study would take about four and a half months total.   "
137129|NCT01489800|"     Complications after radical cystectomy for bladder cancer range from 30-40%, many of which     are related to bowel function. Patients usually wait to eat until return of bowel function,     although there is evidence that after primary intestinal or colonic surgery, patients may     take food ad lib immediately, and that this is is associated with lower complication rate and     shorter length of stay. The investigators hypothesize that early access to oral enteral     nutrition (food at will) after cystectomy and urinary diversion will reduce the complication     rate both in-hospital and within 90 days after hospital discharge.   "
137130|NCT01489787|"     The purpose of this study is to assess the feasibility, safety and efficacy of High Intensity     Focused Ultrasound (HIFU) patients undergoing hepatectomy for colorectal liver metastases.     This is a phase I/II study.   "
137131|NCT01489774|"     Study objectives        -  To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral          doses of CJ-12406 in healthy male subjects.        -  To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to          healthy male subjects.        -  To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406          in healthy male subjects.   "
137133|NCT01489748|"     This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work     capacity of participants with multiple sclerosis (MS) starting on this device. This study     will also evaluate as secondary endpoints various patient-reported outcomes over the     short-term (1 month), including adherence, treatment satisfaction and convenience, and the     long-term (12 and 24 months), including adherence, persistence, quality of life (QOL),     treatment satisfaction and convenience. It will also assess health resource utilization by MS     participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and     will correlate all secondary outcomes with the primary (i.e., work capacity).   "
137134|NCT01489735|"     There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to     diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the     specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the     patient's life and help in choosing treatment of GERD, as well as direct assessment of     treatment efficacy.      In connection with mentioned above, this study is devoted to the estimation of possibility to     use GerdQ in routine practice of Russian physicians.   "
137135|NCT01489722|"     The purpose of this open label study is to evaluate the safety, tolerability,     pharmacokinetics, and efficacy of AZD1208 in patients with recurrent or refractory Acute     Myelogenous Leukemia (AML). This study will have two parts. In Part A, patients will receive     escalating doses to identify the maximum tolerated dose (MTD). In Part B, the efficacy of the     maximum tolerated dose will be evaluated in a expanded group of patients.   "
137136|NCT01489709|"     This study is to evaluate the effect of Vesicare on quality of life (QOL) in female patients.   "
137137|NCT01489696|"     The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron     and tamsulosin both alone and in combination.   "
137138|NCT01489683|"     When not using neuromuscular blocking agent, even at optimal dosage, target-controlled     infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating     conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on     the intubating conditions for tracheal intubation during anesthesia induction of propofol and     remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.   "
137139|NCT01489670|"     This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ®     0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are     treated per routine clinical practice.   "
137140|NCT01489657|"     The purpose of this prospective observational study is to generate further insight into the     numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects     by profiled serum metabolites before and after the surgery and integrated metabolite changes     with clinical data.   "
137141|NCT01489644|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     compare repaglinide and metformin administered as an individual tablets with repaglinide and     metformin administered as a combination tablet.   "
137142|NCT01489631|"     Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation     and hospital discharge might be delayed. Recent research shows that intra-articular     infiltration with local anesthetics and perioperative prescription of gabapentin can improve     outcome.      Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of     patients after total knee replacement surgery which is treated with epidural analgesia or     peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of     postoperative opiate consumption.   "
137143|NCT01489618|"     The main objective of this study is to evaluate and to compare the specific antibody response     to a  prime-boost  vaccine strategy combining the seven valence pneumococcal conjugate     vaccine (PnCj) prime at W0 followed by the administration of the pneumococcal capsular     polysaccharide vaccine (PPS) boost at W4, to the administration of the pneumococcal capsular     polysaccharide vaccine (PPS) alone at W4 in patients with common variable immunodeficiency.   "
137144|NCT01489605|"     Patients presenting for elective surgery requiring orotracheal intubation will be randomized     to being intubated with either the GlideScope Groove video-laryngoscope or the standard     GlideScope video-laryngoscope.   "
137145|NCT01489592|"     The purpose of this study is to determine the impact of curcumin, administrated orally, on     iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin     expression that the investigators observed in vitro and serum hepcidin levels.   "
137146|NCT01489579|"     The purpose of this study is to determine whether giving more structured information to     patients over the phone about quitting tobacco helps to increase the chance that they will     try to quit. The results of this study will help provide direction in developing a more     standard way of helping patients to quit.      Study Hypothesis:      Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy     specialists will significantly increase the percentage of self-reported tobacco cessation     attempts compared to usual care among patients enrolled in a cardiovascular risk reduction     program.   "
137147|NCT01489566|"     This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial.     Patients with no tumor lesions one month after resection of hepatocellular carcinoma will be     randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or     placebo.      The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free     survival,overall survival,quality of life,and the safety and tolerability of subjects after     the resection of hepatocellular carcinoma   "
137148|NCT01489553|"     For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management     includes identification of the causative food and avoidance. Egg allergy is among the most     common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of     children (its prevalence is higher in children with atopic dermatitis or other food     allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim to     investigate the safety and efficacy of baked egg oral immunotherapy.   "
137183|NCT01489098|"     The purpose of this study is to determine if toddlers and children who were fed breast milk     or infant formulas at different levels of protein between 3 and 12 months of age have     differences in growth and body composition at 3 and 5 years of age.   "
137149|NCT01489540|"     Accurate early burn depth assessment is important to determine the optimal treatment. The     most applied method to asses burn depth is clinical assessment. This method is the least     expensive, but not very accurate. Laser Doppler imaging (LDI) has been shown to accurately     assess burn depth. The clinical effects, the costs and cost-effectiveness of this device     however, are unknown. The hypothesis is that an eary accurate diagnosis will lead to an     earlier therapeutic decision: surgery or no surgery. Earlier excision and grafting probably     leads to a decrease in wound healing time, in length of hospital stay and in costs.      Before the investigators decide to implement LDI in Dutch burn care a study of the clinical     effects and cost-effectiveness of LDI is necessary. Therefore a multicenter randomized     controlled trial will be conducted, including all patients with burns of indeterminate depth     (burns that are not obviously superficial or full thickness) treated in the Dutch burn     centres. In total 200 patients will be included in an 18 months period. The patients are     randomly divided in two groups: 'new diagnostic strategy' versus 'current diagnostic     strategy'. Burn depth will be diagnosed both by clinical assessment and laser Doppler imaging     in all patients. The results of the LDI-scan will be provided to the treating clinician in     the 'new diagnostic strategy' group only. Time to wound healing, diagnostic and therapeutic     decisions, and costs are observed.   "
137150|NCT01489527|"     Moffitt Cancer Center is the Coordinating Center for this study.      The purpose of this study is to develop and test the infrastructure to conduct a future Phase     III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus     (HPV) genotype distribution, data needed to design a Phase III trial. The investigators     propose to conduct a Preparedness study among women ages 16-24 years of age residing in a     region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.      The specific aims of this study are to:        1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm,          400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18          [Gardasil]) or placebo vaccine.        2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical          lesion prevalence among young females ages 16-24 years at high risk for HIV infection.        3. Assess the rate of compliance through the 3-dose vaccination series   "
137151|NCT01489514|"     This is a proof of concept study to determine the safety and allergenicity of hypoallergenic     peanut product extract as compared to standard peanut extract in an adult population with     known peanut allergy. This will be assessed by epicutaneous skin prick testing. The     hypothesis is that subjects with previously diagnosed peanut allergy will have less     epicutaneous reactions to the hypoallergenic peanut product extract.   "
137152|NCT01489501|"     This clinical study is a scientific study on patients who do not have any limbal stem cells.     In this clinical study tissue is taken from the inside of the mouth, and cells from that     tissue (epithelial cells) will be grown to form a multilayered cell-sheet, called CAOMECS,     which is then transplanted onto the cornea. This transplantation method should repair the     damage of the cornea.      The aim of this study is to see if the transplantation of CAOMECS renews the surface of the     eye, by preventing the growth of the conjunctiva over the cornea and stopping new small blood     vessels forming.   "
137153|NCT01489488|"     Primary objective: To determine oral bioavailability of the liquid formulation intended for     pediatric use and potential food effects in healthy adults.      Secondary objective: To evaluate safety and tolerability measured by physical examination     findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events     (AEs).   "
137315|NCT01487382|"     This study is conducted in Japan. The aim of this study is to collect safety and efficacy     data when using NovoRapid® (insulin aspart) in children with type 1 and type 2 diabetes under     normal clinical practice conditions.   "
137154|NCT01489475|"     During cardiopulmonary bypass (CPB) after heart surgery, a child's blood is exposed to many     foreign entities. These conditions trigger the body's inflammatory response which results in     leaky capillaries, increased swelling and possibly organ dysfunction. Since the early 1990's,     modified ultrafiltration (MUF) has been shown to decrease excess swelling, reduce bleeding,     improve heart function, and decrease hospital length of stay. Angiopoietins are a family of     proteins necessary for both normal and abnormal blood vessel formation. They also appear to     play a role in capillary leak. Though MUF has been shown to improve clinical outcome     following CPB, there continues to be conflicting reports whether this is a result of the     filtration of inflammatory proteins or simply from excess fluid removal. Since angiopoietins     appear to play a role in both inflammation and capillary leak, the investigators hypothesize     that the benefit seen after MUF is also secondary to its ability to filter out these     proteins, especially angiopoietin-2.   "
137155|NCT01489462|"     The primary purpose of this study is to compare the effects of a high and low intensity     strength training programs vs. a control group on knee pain and compressive joint forces.   "
137156|NCT01489449|"     The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R)     Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.   "
137157|NCT01489436|"     New minimally invasive surgical treatments are often outpatient procedures with low     complication rates, promising fast recovery. The traditional physician-reported outcomes such     as complication rates, blood loss, and hospital stay are not useful to guide treatment     recommendations for one or the other minimally invasive procedure. This study aims to apply     patient-reported outcomes developed within the NIH framework for cancer research and chronic     disease treatment to the comparative effectiveness research in minimally invasive procedures     for benign disease.   "
137158|NCT01489423|"     RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with     ipilimumab with or without sargramostim may help doctors learn more about the effects of     ipilimumab and sargramostim on cells. It may also help doctors understand how well patients     respond to treatment.      PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III     melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.   "
137355|NCT01486862|"     This trial is conducted in North America. The aim of this trial is to investigate the     efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving     glycaemic targets on OADs (oral anti-diabetic drugs).   "
137160|NCT01489397|"     Magnified intelligence chromoendoscopy (FICE) plus probe-based confocal laser endomicroscopy     (pCLE) for Gastric Intestinal Metaplasia (GIM) diagnosis: a feasibility trial      Research Question:      Is confocal endomicroscope feasible to diagnose gastric intestinal metaplasia?      Objective:      To evaluate the feasibility of confocal endomicroscope in diagnose gastric intestinal     metaplasia.      Hypothesis:      Confocal endomicreosocpe can provide the accurate diagnosis of gastric intestinal metaplasia.      Research design:      Diagnostic study      Sample size:      The investigators follow the population in recent study from Imraporn et al.: Validity of     magnify NBI for gastric intestinal metaplasia targeted biopsy (N= 50)      Data analysis:      Confocal Barrett's esophagus classification was used to evaluate agreement of confocal     endomicroscopic finding in gastric intestinal metaplasia. The accuracy of new criteria for     GIM by confocal endomicroscope was evaluated in relation to pathological report, a gold     standard for diagnosis, and reported as sensitivity, specificity, positive predictive value,     negative predictive value and accuracy of these criteria.      Expected Benefit and Application:      The feasibility of confocal endomicroscopy for diagnosis gastric intestinal metaplasia in     order to improve the quality of GIM/dysplasia/early gastric cancer detection and then     decrease the mortality rate from gastric cancer in the future.   "
137161|NCT01489384|"     The purpose of this study is to investigate the safety and efficacy of Cimzia given as an     add-on to your current therapy with disease-modifying anti-rheumatic drug(s)     (DMARDs)including MTX or given as monotherapy (alone) over an 18 month period.      Approximately 125 patients with moderate to severe Rheumatoid Arthritis (RA) who are being     prescribed Cimzia will be enrolled into the study.   "
137162|NCT01489371|"     This phase I trial studies the side effects and the best dose of giving EGEN-001 together     with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian     epithelial, fallopian tube, or primary peritoneal cancer that has returned after a period of     improvement or has not responded to treatment. Biological therapies, such as EGEN-001, may     stimulate the immune system in different ways and stop tumor cells from growing. Drugs used     in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Giving EGEN-001 together with pegylated liposomal doxorubicin hydrochloride may     kill more tumor cells.   "
137163|NCT01489358|"     Background:      - Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache,     muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint     pain, which may be directly related to the infecting virus, may be severe and last for     several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new     experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy     adults. Participants cannot develop CHIKV from this vaccine.      Objectives:      - To test the safety and effectiveness of a Chikungunya virus vaccine.      Eligibility:      - Healthy individuals between 18 and 50 years of age.      Design:        -  This study, including vaccine doses and followup tests, will last about 44 weeks.          Participants will have three vaccination visits, six followup clinic visits, and three          telephone contacts during this study. Vaccination visits will take about 4 hours. Most          other clinic visits will usually take 2 hours. The telephone contacts will take about 15          minutes.        -  Participants will be screened with a physical exam and medical history. Blood samples          will also be collected.        -  Participants will be assigned to one of three dose groups. Information about doses will          be provided before the start of the vaccinations.        -  Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks.          Participants will be asked to keep an eye on the injection site for 7 days and to notify          researchers if there are any side effects.        -  Participants will be monitored throughout the study with blood samples and clinic          visits.   "
137165|NCT01489332|"     The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is     standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to     less than 10%, but has only had limited effect on overall survival due to the constantly high     (more than 30%) rate of distant metastasis.      Complete eradication of the primary tumour observed in the histopathological specimen     (pathological complete response, pCR) correlates with a favourable overall prognosis so     obtaining a pCR might be beneficial. The aim of the study is to investigate whether the     addition of capecitabine based chemotherapy before preoperative chemoradiation and also     before the operation improves pathological complete remission rate in locally advanced rectal     cancer with acceptable toxicity. Secondary objectives are to evaluate pathological     downstaging rate, histopathological R0 resection rate,sphincter preservation rate,     perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality     of life.   "
137166|NCT01489319|"     The purpose of this study is to determine the relationship between lipid-induced inflammation     and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine     the effect of salsalate and polygonum cuspidatum extract (PCE) containing resveratrol on     lipid-induced inflammation, ovarian androgen secretion, body composition and ovulation in a     subset of normal weight women with PCOS.   "
137167|NCT01489306|"     The purpose of the study is to assess the tolerability and safety of a range of repeated     inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and     determination of blood levels of MDT-637 following inhalation.   "
137168|NCT01489293|"     The purpose of this study is to analyze the expression and activity of inhibitory molecules     on eosinophils obtained from allergic subjects.   "
137210|NCT01488747|"     The primary objective of this investigation is to determine the relative percentage and rate     of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3     (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements     versus an encapsulated triglyceride in defined plasma lipid pools.      The primary endpoints to be evaluated include the fatty acid composition of plasma lipids     before and after consumption of a single dose of emulsified triglyceride based fish oil and     triglyceride of similar n-3 compositions in capsule form. The investigators will measure     changes in plasma phospholipid, and chylomicron fatty acids.   "
137169|NCT01489280|"     In this study, the body temperatures of men and women undergoing elective surgery will be     measured using the Temple Touch Pro. In the operating room, each patient's temperature will     be measured with both the Temple Touch Pro and another one or two of the continuous reference     methods used clinically for measuring the core temperature.      The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a     receiving unit. The former is attached to the skin, while the latter is placed near the     patient or the vital signs monitor and receives data from the patch. The core temperature     equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by     conductive sensors that perform skin temperature measurements and then applies a special     algorithm in order to calculate the body's temperature.   "
137170|NCT01489267|"     Hereditary cerebellar ataxia is a type of autosomal dominant genetic disease, lesions mainly     involving the cerebellum, but the spinal cord and cranial nerves may also be some     involvement. A total of 20 molecularly diagnosed SCA1 patients divided in two groups. One     group accepted for the treatment of stem cell transplantation,the other group will be the     control. Purpose of this project to prove that allogeneic umbilical cord mesenchymal stem     cells are applied to clinical safely, and in the treatment of hereditary cerebellar ataxia is     valid.   "
137171|NCT01489254|"     The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer     acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple     sclerosis   "
137172|NCT01489241|"     The purpose of this study is to evaluate whether the introduction of a short-term     telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged     from the hospital after disease exacerbation produces benefits in terms of a reduction in     hospital readmissions and health related quality of life. In addition the trials evaluate the     economical and organisational impact of the services and examine their acceptability by     patients and health professionals.   "
137173|NCT01489228|"     This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in     individuals with chronic indeterminate Chagas disease recruited in research centres in Tarija     and Cochabamba, Bolivia.   "
137174|NCT01489215|"     This study will inform the field about underlying mechanisms associated with infant sleep     problems and will deepen the understanding of the intervention process. The study will     provide detailed information on the intervention process itself and will explore how     behavioral sleep interventions affect broader infant outcome.   "
137175|NCT01489202|"     Percutaneous coronary intervention (PCI) with stenting may induce endothelial     damage/dysfunction and inflammatory reactions, which in turn delay healing and     endothelialization and may lead to restenosis and atherosclerosis within the stented     segments. Drugs and polymers are considered the protagonists of these pathophysiologic     processes whereas the role of stent platforms remains poorly defined.It remains unknown,     conversely, if stent platforms affect the extent of post-PCI endothelial damage and     inflammation.   "
137176|NCT01489189|"     The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in     eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial     growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are     non-inferior to those in eyes that receive standard prompt PRP therapy.      Secondary objectives include:        -  Comparing other visual function outcomes (including Humphrey visual field testing and          study participant self-reports of visual function) in eyes receiving anti-VEGF with          deferred PRP with those in eyes receiving prompt PRP.        -  Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of          prompt PRP.        -  Comparing safety outcomes between treatment groups.        -  Comparing associated treatment and follow-up exam costs between treatment groups.   "
137316|NCT01487369|"     This study is conducted in Japan. The aim of this study is to collect data of production of     insulin aspart specific antibody under normal clinical practice conditions.   "
137177|NCT01489176|"     The purpose if this study is to examine how effective Regadenoson is in detecting coronary     artery disease during a stress echocardiogram when Optison is administered. Optison is a     contrast agent that improves the images of the heart on the echocardiogram (echo) machine.     Optison is approved by the Food and Drug Administration (FDA) to use during stress     echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is     used to chemically increase the heart rate and is approved for nuclear imaging tests.     Regadenoson is a FDA approved drug but not for the intended use in this study.   "
137178|NCT01489163|"     The purpose of this research study is to implement and evaluate a lifestyle program designed     to help women who have high glucose levels during pregnancy make healthful diet and physical     activity changes to lose weight. Eligible women will be randomly assigned to life-style     intervention or usual medical care.   "
137179|NCT01489150|"     In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory     failure, the interest of using the End-tidal Co2 measurement device Capnostream to evaluate     PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under     normal expiration and under prolonged active and passive expiration maneuvers.   "
137180|NCT01489137|"     The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic     changes to head fixation in the patients undergoing neurosurgery.   "
137181|NCT01489124|"     This is prospective, randomized and crossover design to assess the pharmacokinetic and     pharmacodynamics of three regimen.        -  0.5-hr infusion of imipenem 0.5 g every 6 hrs        -  2-hr infusion of imipenem 0.5 g every 6 hrs        -  2-hr infusion of imipenem 1 g every 6 hrs      Clinical and laboratory data such as Age,Sex, Body weight, CBC, Electrolyte, Vital signs,     APACHE II score, BUN, Cr, Sample and Blood culture will be collected.      Nine patients will be enrolled in this study. After completion of the imipenem therapy for 3     days in this study, all patients will receive other sensitive antibiotics to eradicate their     bacterial infections.      Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following     time: 0, 0.5, 1, 2, 3, 4, 5 and 6 after 4th dose of imipenem.      Concentration of imipenem in plasma will be measured by HPLC method. Then, the data will be     simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and     reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).   "
137182|NCT01489111|"     This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect     of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.   "
137184|NCT01489085|"     Rational: Intellivent is a ventilation mode completely automated which controls ventilation     and oxygenation parameters. Safety and performance of IntelliVent has still been demonstrated     in post operative heart surgery for patient with a controlled ventilation on short period (2     to 4 hours). This feasibility study evaluate the use of Intellivent for Intensive care unit     patients from intubation to coming off.      Primary objective : Compare parameters which have been selected by automated mod     (Intellivent) to those selected by clinical practitioner in a conventional mode      Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters.     Record complications, number of manual adjustments and prognostic signs.      Methodology: Patients in the intensive care unit who need invasive ventilation. They will be     included after a detailed information (information note). Oxygenation and ventilation     parameters will be recorded 2 times by day from intubation to coming off. The investigator in     charge will determine daily at the bedside of the patient the adjustments he should make in a     conventional mode. These adjustments will be compared to the IntelliVent automated     adjustments.      Experimental study, observational, prospective, comparative, opened, monocentric in an     intensive care unit.      Number of patients: 100   "
137185|NCT01489072|"     This study is designed to compare the effects of two bolus doses of intravenous remifentanil     given prior to the emergence of anesthesia:        -  on the incidence of perioperative coughing        -  on the time needed for the emergence of a desflurane-based anesthesia        -  on the incidence of sore throat after extubation.      The investigators hypothesis is that the use of a higher remifentanil bolus dose (0.5 mcg/kg)     given prior to emergence of a desflurane-based anesthesia will reduce the incidence of     perioperative coughing when compared to a lower dose of remifentanil (0.25 mcg/kg).   "
137186|NCT01489059|"     The purpose of this study is to determine whether the combination of interleukin-21 (IL-21)     and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the     clinical benefits of the combination compared with Ipilimumab alone   "
137187|NCT01489046|"     The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well     tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for     treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects   "
137188|NCT01489033|"     Based on EMA (European Medicines Agency) new guidelines on the clinical development of     products for immunotherapy for the treatment of allergic disease the aim of this study was to     assess safety and tolerability of three different subcutaneous immunotherapy dose escalations     in patients allergic to the pollen of Phleum pratense.   "
137189|NCT01489020|"     Based on EMA (European Medicines Agency) new guidelines on the clinical development of     products for immunotherapy for the treatment of allergic diseases the aim of this study was     to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations     in patients allergic to Dermatophagoides pteronyssinus.   "
137198|NCT01488903|"     Not many studies examined genetic determinants of obesity in women. As pre-menopausal and     post-menopausal women appear to have different propensities for fat deposition, genetic loci     linked with obesity-related phenotypes might be different by menopausal status. So far, there     is no large scale of genetic study deciphering common obesity focusing on women population to     examine the contributions of aging and change in menopausal status to obesity in Taiwan. The     investigators propose this study to compare phenotypic profiles of obesity and     cardio-metabolic factors in pre-menopausal and post-menopausal women. The study will examine     the contributions of aging and change in menopausal status to the changes of obesity-related     traits during the transition from pre-menopause to post-menopause period, and will evaluate     the contribution of genetic susceptibility on body fat deposition among women at different     stage of menopause.   "
137190|NCT01489007|"     Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet     for children. Advocates make strong health claims whereas others have expressed safety     concerns, especially regarding iron nutrition. The frequency of vegetarianism among children     is said to be rapidly increasing although clear data are not available. Surveys of children     in the US age 8 to 18 reported in the media find that about 3-5% of children are lacto-ovo     vegetarian, with some fish or chicken products in the diet. This is a substantial proportion     that is very likely to increase over the next few years with essentially no nutrient     metabolism data related to this population.      One of the principal concerns with a lacto-ovo vegetarian diet, as preferred by many     children, is the lack of heme iron in the diet. A key question that can be evaluated in     children is whether iron status is in fact affected by a lacto-ovo vegetarian diet.      According to the American Academy of Pediatrics (AAP Pediatric Nutrition Handbook, 6th     Edition, 2008), vegetarian diets can provide appropriate nutrition for children. Depending on     the level of dietary restriction, fortified foods or supplements may be necessary during     different life stages. In addition, strict vegetarian children may have slightly higher     protein needs compared to non-vegetarian children due to decreased protein digestibility in     certain plants. The AAP further recommends that children 4-8 years old consume a minimum of     five servings per day of beans/nuts/seeds/eggs and six servings per day of calcium-rich     foods.      To evaluate this issue, the investigators will use a stable isotope method to directly assess     iron status. It is increasingly recognized that the ability to absorb iron when given with     vitamin C is a highly accurate measurement of iron status and may be a true gold standard in     this regard. In this planned study, investigators will be able to assess both reference dose     iron absorption and standard biochemical markers of iron status in a group of lacto-ovo     vegetarians and compare them with age- and gender-matched children on a non-vegetarian diet.     These data can be important in determining if iron status is decreased in lacto-ovo     vegetarians and will serve as a basis for future interventions and evaluations if a     difference is found.   "
137191|NCT01488994|"     The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its     hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in     pediatric patients.   "
137192|NCT01488981|"     This study will evaluate the feasibility of using fully implanted microstimulators to     rehabilitate arm function in patients who have suffered a traumatic brain injury.   "
137193|NCT01488968|"     Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver     higher biological doses to targets in order to improve tumor control and with acceptable     rectal toxicity compared to conventional fractionation.   "
137194|NCT01488955|"     In this study, patients with uncomplicated urinary infection are investigated. It is     investigated if treatment of only symptoms of the uncomplicated urinary infection is as     effective as treatment with antibiotics with respect to the outcome of the urinary infection.     If this is the case, the use of antibiotics in the treatment of uncomplicated urinary     infections might be reduced.      Secondary aim of the study is the safety evaluation of both treatment strategies with respect     to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.   "
137206|NCT01488799|"     The current study examines whether change-readiness, and consequently treatment outcome, can     be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder     (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra &     Dozois, 2003) before and during CBT when motivation wanes. 106 individuals with severe GAD     will be randomly assigned to receive an equal number of sessions of either MI and CBT (MI-CBT     arm) or CBT alone (CBT alone arm). It is expected that the MI-CBT arm relative to the CBT     alone arm will show lower levels of resistance in CBT, higher levels of homework compliance     and therapeutic alliance, better moment-to-moment interpersonal process, and consequently     superior outcomes - both post-treatment and at 6 and 12 month follow-ups.   "
137207|NCT01488786|"     The purpose of this study is to assess the safety of the BrainPort vision device and to     demonstrate improved object recognition and word identification and ambulation with use of     the BrainPort vision device in subjects who are medically documented as blind, with acuity of     20/ 5000 or worse.   "
137195|NCT01488942|"     In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV     infection among users of illicit drugs. Among drug users who present to care and start highly     active antiretroviral therapy (HAART), retention in care and adherence to their treatment     regimen may be less than optimal. Given the known benefits of HAART on both the individual     and populational levels, new strategies are required to help retain HIV-infected drug users     on HAART.      Contingency management (CM) is a strategy to affect behaviour by providing a reward (e.g.     money) to reinforce the desired behaviour. CM has been used with success in other areas of     medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has not     been established as a means to improve retention in HAART programs.      The proposed research primarily seeks to assess the effectiveness of monetary-based CM in     retaining HIV-infected drug users in HAART programs. 240 HAART-eligible subjects will be     randomized in a 2:1 ratio to either receive (n=160) the reinforcer or to a control arm     (n=80). All subjects will receive HAART and standard care, and those randomized to the     reinforcer arm will receive escalating reinforcement initially for attendance at each clinic     visit (until month 6 after starting HAART) and subsequently (until month 12 after starting     HAART) will receive an escalating variable reinforcer for each month in which a plasma viral     load less than or equal to 100 copies/mL is maintained.      Our hypotheses are that drug users initiating HAART and randomly selected to receive a     reinforcer for attending clinic visits then maintaining monthly virologic suppression during     the first 52 weeks after HAART initiation will be significantly more likely to achieve     virologic suppression at 52 weeks, will have a significantly longer duration of sustained     virologic suppression during the first 52 weeks, and will be significantly more likely to     maintain virologic suppression at 72 weeks after HAART initiation, than those not offered a     reinforcer.   "
137196|NCT01488929|"     Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of     schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on     the function, employment, and social interactions of patients with schizophrenia. Medications     used to treat schizophrenia (e.g. atypical antipsychotics) do not improve negative symptoms     or CDS. TC-5619 is being developed for use as an add-on therapy in combination with atypical     antipsychotics to treat patients with negative symptoms and CDS.   "
137197|NCT01488916|"     Vitamin D deficiency is associated with an unfavorable metabolic profile in several     observational studies. However, the influences of vitamin D concentrations on postprandial     glucose in type 2 diabetes (DM) are less studied. The purposes of the study are to study the     effects of vitamin D inadequacy on postprandial glucose excursion and metabolic responses in     patients with type 2 DM. This is a cross-sectional study. About 150-180 patients will be     screened for serum levels of 25(OH)D. A total of 45 eligible patients will be grouped into     three groups by different vitamin D status: vitamin D deficiency, vitamin D insufficiency,     and the controls. The patients will receive a mixed meal test for postprandial glucose     excursion and metabolic responses. The investigators will use statistical methods to assess     the differences in post-challenge glucose and metabolic response among the three groups of     patients. The investigators hope the study can explore the relationship between vitamin D and     glucose excursion in patients with type 2 DM.   "
137258|NCT01488123|"     The purpose of this study is to determine whether a four-month manualized Ayurvedic     intervention will improve quality of life in recent breast cancer survivors.   "
137199|NCT01488890|"     The aim of this study is to evaluate the administration of CYD dengue vaccine following a     compressed schedule in different populations.      Primary Objectives:        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes          at baseline and 28 days after CYD dengue vaccine Dose 3 in defined study groups.        -  To describe the persistence of the humoral immune response to each of the 4 parental          dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in defined study groups.      Secondary Objective:        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes          at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in defined study          groups, irrespective of whether or not Yellow fever (YF) vaccine has been previously          administered.        -  To describe the YF humoral immune response at baseline and 1, 3, and 7 months after          injection of the YF vaccine at Month 0 in Groups 3 and 4.        -  To describe the safety profile in terms of solicited injection site and systemic events,          unsolicited adverse events and serious adverse events after each injection of CYD dengue          vaccine and/or YF vaccine.   "
137200|NCT01488877|"     PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary     purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and     pharmacodynamics of multiple doses of PF-03882845 in this population.   "
137201|NCT01488864|"     The objectives of this study are to compare frequency and severity of moderate to severe     vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an     untreated control-group (CG) and to investigate if Health Related Quality of Life improve in     the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change     within the AR treated group compared with the control group.   "
137202|NCT01488851|"     Prospective observational multi central cohort study to assess the incidence of osteo     necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment   "
137203|NCT01488838|"     A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus     Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors   "
137204|NCT01488825|"     The present study was designed to evaluate effect of yoga intervention on patients having     frequent tension type headache.   "
137205|NCT01488812|"     This study investigates the relationship between waiting time to surgery and the risk for     medical complications and 1-year mortality in hip-fracture patients.   "
137208|NCT01488773|"     The objective of the study was to compare in real life clinical practice two treatment     regimens: inhaled glucocorticosteroid + salmeterol and inhaled glucocorticosteroid +     montelukast.   "
137209|NCT01488760|"     The purpose of this study was to evaluate feed-forward contraction of the transversus     abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus     externus during calm and standardized respiration in low back pain patients and pain-free     subjects.   "
137211|NCT01488734|"     The purpose of this study is to compare the safety and efficacy of two different amounts of     vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the     daily meals versus same doses of vitamin D3 provided as oral supplements sold in any     drugstore in reaching adequate or optimal blood levels of 25(OH)D in people with Vitamin D     deficiency and pre-diabetes (high blood sugar without full blown diabetes) or the metabolic     syndrome. Metabolic syndrome is the name of a group of risk factors that raise the risk for     heart disease and other health problems, such as diabetes and stroke as described by the US     department of Health and Human Services.      This study will also attempt to demonstrate and compare the effect of the intervention with     above two doses of vitamin D on blood levels of tests that show inflammation.   "
137212|NCT01488721|"     The purpose of this study is to assess the agreement of clinical performance between the     proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in     newborn screening programs for detection of T4, TSH, 17-OHP and IRT.   "
137213|NCT01488708|"     The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399     in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).   "
137214|NCT01488695|"     A new GlideScope videolaryngoscope has been developed, which utilizes a track on the superior     surface of the blade to guide the endotracheal tube, which is advanced in the track as     opposed to free-hand along the inferior surface, where the camera is located. This new     GlideScope can be used for double-lumen endotracheal tubes (DLT). The investigators     hypothesize that this GlideScope will be easier to use than the Macintosh blade.   "
137215|NCT01488682|"     Recently, the HS has been used in head and neck surgery as an alternative to conventional     hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have     been published on the evidence of its safety in ND, especially in radical ND. Researchers     investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND),     while using conventional hand-tied ligation to a minimum, in terms of operating time, blood     loss, drainage and complications.   "
137216|NCT01488669|"     In this study we introduce and evaluate the feasibility of our surgical technique to hide the     external scar of neck dissection using the robotic system via a modified facelift or     retroauricular approach.   "
137217|NCT01488656|"     This study will determine if a comprehensive antioxidant/anti-inflammatory dietary supplement     pack can offer protection against a decline in lung function and increase in inflammation and     oxidative stress following acute exposure to particulate matter air pollution with a diameter     <2.5 µm (PM2.5).      The investigators hypothesis is a follows: Compared to an appropriate control,     supplementation with a comprehensive antioxidant/anti-inflammatory dietary supplement pack     for 18 weeks will: 1) reduce the decline in lung function following acute exposure to     naturally occurring elevations in PM2.5 levels as measured by exhaled nitric oxide levels and     forced vital lung capacity; and 2) reduce changes in pro-inflammatory cytokines following     acute exposure to naturally occurring elevations in PM2.5 levels as measured by plasma levels     of C-reactive protein.   "
137218|NCT01488643|"     There is increased frequency of asthma in obese patients. This study is trying to find out if     there is a difference in the presence of bronchospasm during anesthesia in obese and non     obese patients.   "
145458|NCT01380470|"     The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive     Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region     of Murcia   "
137219|NCT01488630|"     The lack of substance screening and referral in healthcare settings is a significant problem     with far-reaching consequences, including excess morbidity, premature mortality, and inflated     healthcare costs. An easy to use, time-efficient referral system is needed to address this     problem. The Substance Treatment Referral Systems (STaRS), a computer assisted screening and     referral system, was developed to meet this need.      STaRS Phase I demonstrated the feasibility of STaRS to meet this need. All aims and     evaluation goals of the Phase I study were met or exceeded. The purpose of the Phase II     research is to demonstrate the clinical utility and commercial viability of STaRS.      Specific Aims of Phase II are:        1. Integrate STaRS with the Epic electronic health record used in the Cooper Health System          in Camden, N.J.        2. Document STaRS' effectiveness in (a) increasing the number of referrals provided for          substance abuse treatment and HIV screening, and (b) increasing the proportion of          patients that initiate specialty treatment.        3. Evaluate clinician acceptance and impact upon revenue generation.      The research will be conducted at Cooper Family Medicine (CFM) department of Cooper     University Hospital in New Jersey. We will determine the rate of referrals and treatment     initiation for 3,500 adult patients treated during treatment as usual (the time before STaRS     is implemented at CFM) as well as 3,500 adult patients treated after the introduction of     STaRS. Patients will be asked about the referral initiation process, and CFM healthcare     providers will be asked to evaluate the system from a clinical and administrative     prospective. Finally, billing records will be reviewed during the STaRS implementation to     determine whether STaRS impacted revenue for the practices.   "
137220|NCT01488617|"     The purpose of this study is to determine whether psychological and social factors in     addition to medical (physiological) conditions may contribute significantly to the prediction     of the postoperative outcome.      Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and     (2) alteration of quality of life.   "
137221|NCT01488604|"     This study will test 200 people to see if an experimental nasal spray has an effect on     symptoms of the common cold if used when the symptoms start. At the first visit to the     clinic, potential subjects will have tests to make sure they qualify to participate in the     study.      If they qualify, they will have an equal chance of receiving the experimental nasal spray or     a sham nasal spray (one that does not have the experimental formula). At the first visit,     subjects will receive their assigned nasal spray and use it once at the clinic. They will     also receive a booklet called a diary. Subjects will take the rest of their treatments for     day 1 at home, and for the next six days, they will use the nasal spray four times per day     and record their symptoms in the diary, as instructed. Then subjects will come back to the     clinic for a final visit.   "
137222|NCT01488591|"     The aim of this study :        1. Through the study of genes of protein, transporter, translator and epigenome          investigating the effect of anti-cancer treatment or the key factor of the MDR          (Multidrug resistance) on the blood cancer patients who are under the anti-cancer sork          treatment        2. Giving a service of anticancer medicine therapeutic drug monitoring (TDM) and genotyping   "
137224|NCT01488565|"     Myelodysplastic Syndrome (MDS) is a disease of the bone marrow characterized by     anemia,neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet     counts). MDS patients with thrombocytopenia who fail standard therapies require regular     platelet transfusions which are expensive and inconvenient, and are a risk for further     serious bleeding complications. The new treatment of MDS using azacitidine has shown to     increase the survival rate of MDS patients including to improve platelet production over     time. However,in the early cycles of treatment with azacitidine,the low platelet counts tend     to exacerbate before they provide any clinical benefit.      Eltrombopag is a drug designed to activate the thrombopoietin receptor. Eltrombopag has been     able to increase platelet counts in healthy Thrombocytopenia Purpura (ITP), a disease where     patients destroy their own platelets very rapidly and thus develop thrombocytopenia.      Eltrombopag is administered orally and is Therapeutic Goods Administration (TGA) approved for     the treatment of thrombocytopenia in patients with chronic ITP who failed to respond to     standard treatment.      This study is a single arm pilot study to evaluate the safety and tolerability of Eltrombopag     in the treatment of low platelet counts in adult subjects with MDS treated using azacitidine     This study also incorporates a correlative laboratory component designed to determined the     mechanism of action of 5-azacitidine +/- Eltrombopag and to determine a baseline profile     which may predict those most responsive. These studies will incorporate gene methylation and     expression, and immunoprofiling.   "
137225|NCT01488552|"     The Investigators in the PCRT team have developed a therapeutic regimen which attacks both     the tumor compartment and the stromal compartment of pancreatic cancer and induces complete     responses in a small percentage of patients with advanced stage IV pancreatic cancer.   "
137226|NCT01488539|"     Researchers hope to learn whether a flexibly applied cognitive behavioral treatment for     Post-Traumatic Stress Disorder (PTSD) is more effective than the psychotherapy usually     provided in the clinic (called Treatment as Usual or TAU). Primary Hypothesis: STAIR/NT will     be superior to TAU in improving PTSD symptoms at 28, 36 and 48 weeks post-randomization   "
137227|NCT01488526|"     Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains     a concern and has been reported in approximately 8-15% of infants born to hepatitis B e     antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10     copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior     observational studies have shown that antiviral therapy including lamivudine or telbivudine     use during late pregnancy can safely reduce the rate of vertical transmission in this special     population compared to untreated patients.      Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes     serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse     effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this     study:        1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10          copies/mL (or > 200,000 IU/mL) during late pregnancy and infants.        2. Its efficacy in the reduction of HBV vertical transmission rate.   "
137228|NCT01488513|"     This phase I trial studies the side effects and best dose of ABC294640 in treating patients     with advanced solid tumors. ABC294640 may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Please note that the FDA OOPD is participating as a     funding source.   "
137229|NCT01488500|"     Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common air     in many parts of the world and previous studies indicate that wood smoke induce oxidative     stress in the respiratory tract. It is not determined how different types of biomass     combustion affect human health. In this study the investigators plan to investigate how     inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.   "
137230|NCT01488487|"     The purpose of this study is to estimate the time to disease progression when everolimus and     pasireotide are given together in patients with advanced or metastatic HCC who have not had     any prior systemic therapy.   "
137231|NCT01488474|"     The prevalence of diabetes mellitus (DM) in industrialized countries is estimated to be about     7.3% and its incidence has been growing in recent years. The prevalence of diabetic     neuropathy in the diabetic patient population is up to 50%. When limb surgery is necessary,     it is reasonable to assume that diabetic patients will benefit from a peripheral regional     anesthesia because of the severe comorbidities associated with DM. On the other hand, the use     of regional anesthesia (RA) has generally not been recommended in patients with preexisting     neuropathies mainly because of medical liability issues, as worsening neuropathy could be     attributed to nerve damage caused by the regional anesthetic. The current state of the art of     peripheral regional anesthesia for the identification of correct placement of an injection     needle suitably close to the target nerve is to elicit a motor response by current injection     through the needle. Constant reduction of the current as the nerve is approached ensures     close proximity so that an effective nerve block is obtained when the local anesthetic is     delivered through the needle, and absence of a motor response at 0.3 mA is generally accepted     as a safety marker to avoid harmful intraneural injection. An important deficit in our     understanding is whether diabetic neuropathy influences the stimulation parameters for     peripheral nerve stimulation (PNS), possibly decreasing safety.      The currently proposed research is guided by the hypothesis that nerves in patients with DM     are more resistant to stimulation and the current thresholds for PNS have to be set much     higher to prevent injections from occurring within the epineurium. The investigators will     examine the effect of DM on nerve excitability in a blinded, prospective, observational case     control trial. Accordingly, the investigators have defined following aims:      Specific Aim 1: To characterize the required stimulation current in patients with and without     diabetes mellitus.      Specific Aim 2: Follow-up to examine if the rate of adverse neurologic events is higher in     diabetic patients.      Specific Aim 3: Guided by the results, formulate recommendations for the performance of     regional anesthesia in patients with a history of DM.      These experiments will provide better understanding of the needle-current-nerve relationship     during peripheral nerve stimulation. Findings from this study will have a major impact on     patient safety, especially in the subgroup with preexisting neuropathy, undergoing regional     anesthesia.   "
137244|NCT01488305|"     Helen Keller International (HKI), the ministry of health and population, and ministry of     agriculture and cooperatives, of Nepal and local non-governmental organizations (NGO)     partners are currently implementing a USAID funded Action Against Malnutrition Through     Agriculture (AAMA) project in Baitadi district located in far Western development region of     Nepal. HKI is undertaking this study within the AAMA project to test whether providing     micro-nutrient powders (MNPs) in a programmatic context along with homestead food production     (HFP) and an intensive community level Infant and Young Child Feeding Behavior change     communication (IYCF-BCC) intervention will have a greater impact on reducing anemia and     improving growth in young children than only providing the HFP and IYCF-BCC intervention     without MNPs or a control with no intervention.   "
137460|NCT01485497|"     The purpose of this study is to determine whether the Optical coherence tomography (OCT) can     image the structure and geometry of hollow organs of the upper airway in sleep disorder. The     research can identify the obstruction sites that help the select the appropriate treatment     for potential surgical candidates.   "
137232|NCT01488461|"     Congenital ataxias (CA) are rare, non progressive diseases, characterized by psychomotor     retardation, hypotonia followed by ataxia. The presence of the molar tooth on MRI allowed     to define Joubert syndrome, a peculiar form of CA. Apart from this group, CA are mostly     associated with cerebellar atrophy or hypoplasia without molar tooth on MRI. CA are a     clinically as well as genetically heterogeneous group of diseases. Early-onset ataxias are     progressive but may be difficult to distinguish from CA in the first years of the disease. To     date, few genes responsible for CA have been identified: ABC7 (X-linked CA associated with     sideroblastic anemia), SLC9A6 (X-linked CA associated with severe mental retardation, autism     and epilepsy), GPR56 (CA associated with polymicrogyria), ATCAY (pure CA in Cayman isolate);     the involvement of the ATCAY and ABC7 genes has never been assessed in a large cohort of CA     patients.      Primary objective:      To assess the frequency of mutations of the ATCAY and ABC7 genes in patients affected with     non Joubert congenital or early-onset ataxia.      Secondary objective:      To identify new loci and/or genes responsible for CA To further describe the clinical     phenotype of the CA and to assess the frequency of the various clinical types (pure CA/CA     associated with spasticity/ syndromic CA, congenital/early-onset CA, sporadic/familial CA).      To describe the clinical phenotype of CA related to mutations in one of analysed genes.   "
137233|NCT01488448|"     The purpose of this study is to determine if nebulized hypertonic saline (or extra salty     water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad     chest colds) get better enough to be discharged from the hospital sooner than those infants     given nebulized normal saline (or regular salty water mist).   "
137234|NCT01488435|"     The purpose is to determine if the consumption of study product has an effect on acute     respiratory infections and/or diarrheal disease.   "
137235|NCT01488422|"     This study will identify neural mechanisms associated with changes in emotion regulation     following participation in stress reduction programs.   "
137236|NCT01488409|"     The purpose of the study is to examine whether a medication called acipimox can improve your     body's mitochondria. Mitochondria are the power house of the cell and make energy for your     body.      Obesity is associated with increased risk for developing diabetes. However, the investigators     do not know how obesity leads to diabetes. Previous studies have shown levels of fat in the     blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can affect how our     body uses glucose and responds to insulin. Recent studies have shown that changes in     mitochondria may be involved in the development of diabetes and may be affected by FFA. The     investigators propose to improve the function of mitochondria in obese people with     pre-diabetes by treating with acipimox, a medication which decreases FFA. The investigators     will use state of the art techniques to evaluate the mitochondria, including a new magnetic     resonance imaging (MRI) technique to measure function of mitochondria in muscle.   "
137237|NCT01488396|"     The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic     emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by     subjective symptoms and signs.   "
137408|NCT01486173|"     The main goal of this study is to determine the association between:        -  the quantity of mother's milk and duration of breastfeeding        -  the intake of polyunsaturated fatty acids and iron during hospitalization and the          development of preterm infants born with a GA < 32 weeks.   "
137238|NCT01488383|"     A natural sweetener (Stevia Rebaudina Bertoni) reduces blood glucose levels and blood     pressure according to various preclinical and clinical studies conducted worldwide. Since it     is not found many studies in the literature wich compares Stevia Rebaudiana with saccharin,     we've proposed a randomized crossover clinical trial comparing the effects on postprandial     capillary blood glucose and blood pressure in healthy adults.      Sample: healthy professionals from two health centers in Alava (Kakuabizkarra primary care     center and Txagorritxu hospital). Inclusion criteria: Professionals of two health centers of     Álava (Lakuabizkarra and Txagorritxu) and active employment status at the beginning of the     trial, weighing more than 50kg and age over 18 years.      Intervention: 200mg capsules of Stevia or 250mgcapsules of saccharin. Measurements: Capillary     blood glucose and blood pressure, fasting and after eating. Evaluation of satiety, hunger and     fullness by questionnaire after intake, and at the end of the day.      Statistical analysis: Compare the postprandial capillary glucose levels between 8 am and 1 st     hour, 2nd hour 3rd hour after intake between treatments by ANCOVA. We will also compare blood     pressure before and after intake between treatments. We will also compare by t test or paired     Wilcoxom (depending on the nature of the variable) the results of the questionnaire after     intake between treatments.   "
137239|NCT01488370|"     This is a prospective randomized clinical study to be performed in pediatric patients under     the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation.     Time to endotracheal intubation will be compared between patients intubated using a     GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and     those intubated by standard direct laryngoscopy. The study hypothesis is that the time to     endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when     compared to the GlideScope® video laryngoscope group and standard laryngoscopy.   "
137240|NCT01488357|"     Deciding whether or not to have breast reconstruction after mastectomy is highly challenging     for many patients. This study will examine patients' decisions about reconstruction and the     effects of reconstruction on quality of life and body image.   "
137241|NCT01488344|"     RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid     leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of     BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells.      PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose     cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works     in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II).   "
137242|NCT01488331|"     This prospective, multi-center, observational study will assess the progression-free survival     and safety of patients with locally advanced or metastatic non-small cell lung cancer treated     with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be     collected for 24 months.   "
137243|NCT01488318|"     This is a single-arm, non-masked, open-label, Phase II study of cetuximab + dasatinib in     recurrent Squamous Cell Carcinoma of The Head and Neck (SCCHN) that has recurred after     cetuximab-containing therapy (please see attached schema).      The primary endpoint 12-week PFS.   "
137265|NCT01488032|"     The purpose of the study is to prove if there is any difference in the nerve fiber layer     between patients with normal- and high-tension-glaucoma with similar structural optic nerve     head parameters.   "
137245|NCT01488292|"     This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special     education students in behavioral classrooms. The program includes multiple service     components: the RECAP classroom mental health curriculum, which develops students' behavioral     and social skills; reading intervention; individualized skills training; and parent group.     Schools are randomly assigned to the treatment or control group. This two-year     multi-component mental health and academic intervention is hypothesized to improve students'     mental health, social skills, and academic functioning.   "
137246|NCT01488279|"     The investigators hypothesize that sitagliptin will significantly reduce impairments in     insulin secretion and insulin resistance resulting from short-term oral glucocorticoid     therapy.   "
137247|NCT01488266|"     The objective of this study is to compare the efficacy and safety of aripiprazole as     adjunctive therapy versus switching to different class of antidepressants for treating major     depressive disorder partially or minimally responsive to ongoing antidepressant treatment.   "
137248|NCT01488253|"     Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a     graft-versus-host disease prophylaxis, the investigators are going to perform a phase II,     multicenter clinical trial after human leukocyte antigen (HLA)-matched, related peripheral     blood stem cell transplants (PBSCT) in patients with hematologic malignancies. Total 116     patients will be accrued.      Objective: The primary objective is to evaluate the rates of 100 day Grade II-IV acute GVHD.     Secondary objectives include the time to neutrophil and platelet engraftment, the incidence     of grade III-IV acute GVHD, non-relapse mortality during 100 days after transplant, mucositis     severity, all infectious complications including cytomegalovirus (CMV) reactivation, vascular     complications (venoocclusive disease of liver; VOD, thrombotic microangiopathy; TMA),     disease-free survival, and overall survival at 1 year after transplant.      Eligibility Criteria: Eligible patients are between 20 and 60 years of age, have acute     leukemia, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and adequate     organ function. For available sibling donor, a serologic (or higher resolution) 6/6 Class I     HLA-A and B and molecular Class II DRB1 must be matched.      Treatment Description: Conditioning regimens will vary by center and donor will donate     peripheral blood stem cells according to local institutional practices. Peripheral blood stem     cells will not be manipulated or T-depleted prior to infusion. Tacrolimus will be     administered at 0.05 mg/kg/day intravenously by continuous infusion beginning on day -1 with     a target serum concentration of 5 to 10 ng/mL. Sirolimus will be administered as a 6 mg oral     loading dose on day -1, followed by a 3 mg/day single dose, with a target serum concentration     of 3 to 12 ng/mL. Levels will be monitored weekly during hospitalization and then as     clinically indicated. Intravenous tacrolimus will be converted to an oral equivalent dose     prior to discharge and both immunosuppressives will be tapered beginning at day +100 after     transplantation and eliminated by day +180 when clinically feasible.      Accrual Period: The estimated accrual period is three years. Patients will be followed for     100 days post transplantation for evaluation of the primary endpoint, with additional     follow-up to two years after transplantation for evaluation of secondary endpoints.   "
137249|NCT01488240|"     The purpose of this study is to determine the effects (good or bad) of pulsed dye laser     treatment in burn scar height, texture, redness and pliability in acute burn injury.   "
137250|NCT01488227|"     Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce     injuries and illnesses, and improve performance in collegiate swimmers and divers.      Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course     of the intervention period.   "
137417|NCT01486056|"     This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG     data.   "
137251|NCT01488214|"     Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This     disease is usually thought to spare central nervous system. However, neuropsychiatric     manifestations like depression and cognitive functions impairment seem to be frequent.     Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter     hyperintensities have been reported suggested CNS vascular manifestations in systemic     sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric     manifestations in systemic sclerosis is unknown. The primary objective of this prospective     and multicentre study is to assess a link between neuropsychiatric manifestations and CNS     involvement in systemic sclerosis. Secondary objectives are to assess the frequency of     neuropsychiatric manifestations, to compare central nervous system abnormality between     scleroderma patient and healthy subjects. Central nervous system involvement and     neuropsychiatric manifestations will be systematically assessed through central nervous     system imaging and questionnaires.   "
137252|NCT01488201|"     This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate     safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous     administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.   "
137253|NCT01488188|"     Background: It is well established that live attenuated organisms can be highly effective     vaccines, immune responses elicited can often be of greater magnitude and of longer duration     than those produced by non-living antigens and are often able to confer protection after a     single dose. Unlike killed influenza vaccine preparations injected by the parenteral route,     live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses     in the airway mucosae and can also evoke cell mediated responses. T cell proliferation,     cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity have     all been elicited by live attenuated vaccines.      There has been a history of the use of live attenuated flu vaccines as safe and effective     vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted     influenza vaccines have been proved to be highly efficacious to protect against clinical fly     symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has     been approved by the US FDA. Recent side by side clinical trials have demonstrated that this     nasal vaccine was significantly superior to conventional killed flu vaccine in protecting     against flu symptoms.      Sublingual administration of live influenza virus at a dose lethal by the nasal route was     well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent     Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of     recombinant cholera toxin B subunit (rCTB,up to 1 mg) in healthy adult volunteers was found     to be safe.      A major issue has arisen regarding the ease with which vaccines could be administered to     young children, especially infants, and to elderly subjects in whom nasal vaccination has not     been possible and/or approved due to difficulties of administering nasal vaccines in infants     and to undesired side effects related to frequent rhinitis and sneezing episodes in elderly     subjects. This study is designed to investigate the safety, tolerability and immunogenicity     of a new route of administration of vaccines, using the nasal FluMist formulation as     prototype vaccine.      Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza     virus vaccine (FluMist) in healthy adult volunteers      Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will     receive vaccine via nasal and sublingual route, respectively   "
137254|NCT01488175|"     The purpose of this study is to investigate if the use of a tourniquet during insertion of a     cemented primary total knee arthroplasty will influence clinical and radiological (measured     with RSA X-ray technique) outcome.   "
137255|NCT01488162|"     This multi-center, prospective, observational study will describe the management of relapsing     or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2     years.   "
137266|NCT01488019|"     This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term     safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary     Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of     double-blind treatment.   "
137256|NCT01488149|"     Intrapartum epidural analgesia has been associated with adverse breastfeeding outcomes. One     potential mechanism involves transfer of epidural fentanyl across the placenta and neonatal     blood-brain barrier, where it can subsequently attenuate neonatal exhibition of feeding     behaviors, such as latching and swallowing, during the immediate postpartum period. Vigorous     feeding behavior during the first days of life is a significant predictor of long-term     breastfeeding success at 3 and 6 months. In a randomized, controlled, double-blinded study,     neonatal Neurologic and Adaptive Capacity Scores (NACS) were significantly lower when mothers     received >150 mcg epidural fentanyl versus bupivacaine-only analgesia, and mean umbilical     cord fentanyl concentration was significantly higher in the >150 mcg versus <150 mcg group.      The investigators hypothesize that epidural fentanyl-bupivacaine analgesia is significantly     associated with decreased breastfeeding rates at hospital discharge and with neonatal     deficits in latching onto the breast and swallowing during the first three hours of life, and     that a significant dose-response relationship exists with respect to total micrograms     fentanyl infused.      The investigators will perform a prospective cohort study of all parturients age 18+ at UHCMC     over a three-month period, excluding those with multiples gestation, Cesarean section, or     neonatal intensive care unit admission. From patient charts, the investigators will record     the following variables: number of neonates delivered; type of delivery (spontaneous vaginal     / operative vaginal / Cesarean section); whether the neonate was admitted to the intensive     care unit; the mother's age, height, weight, gravity, parity, intention to breast-feed at the     time of hospital admission, number of children previously breast-fed, and ethnicity;     gestational age at the time of delivery; administration of oxytocin for labor augmentation     and in what quantity; duration of active labor; antibiotic administration; neonatal APGAR     scores at 1 and 5 minutes postpartum; and whether opioids or antibiotics were administered     before and/or after the delivery and at what exact time. We will also record whether each     patient received an epidural during labor and, if so, the duration of this epidural infusion     and the total micrograms fentanyl delivered; neonatal feeding behavior as quantified by the     LATCH scores assigned to each breast-feeding interaction that occurs on the postpartum care     floor; whether the mother is breast-feeding her baby at the time of discharge from the     hospital, and if not, then her primary reason for not doing so (as communicated during the     standard postpartum lactation consultation); and how long mother and baby stayed in the     hospital post-delivery.   "
137257|NCT01488136|"     The investigators know that intensive insulin therapy and tight glucose control is associated     with reduction of diabetic complications. However, many patients on insulin don't achieve     this because of the risk and the fear of hypoglycaemia (too low blood glucose).      There has been a lot of work done recently looking at the mechanisms by which the brain     detects hypoglycaemia. A key player is a potassium channel in the brain (KATP channel).     Studies have shown that when these channels are opened, there is a release of hormones such     as adrenaline that can help in raising blood sugars to counteract and increase awareness of     hypoglycaemia. The investigators study aims to look at an old drug called diazoxide, which is     able to open KATP channels.      The investigators aim to see if diazoxide will amplify the release of hormones such as     adrenaline when the blood sugar is low. If this is the case, this will aid quicker recovery     following hypoglycaemia.      The investigators aim to do this by performing a well established experimental protocol that     has been performed safely over the last 20 years called a clamp study. The clamp study will     involve slowly bringing the blood sugars down using insulin and intravenous glucose in a     controlled fashion. The main outcome will be the hormonal responses (adrenaline response) at     a blood sugar level of 2.5mmol/L. Symptoms of hypoglycaemia will be monitored, as well as     working memory tests using standardised questionnaires.      The design of the investigators study will be a randomised trial comparing the effects of     diazoxide with placebo in which all patients will receive both diazoxide and placebo in     random order (crossover design).   "
145459|NCT01380457|"     The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg     capsules verses Marinol.   "
137260|NCT01488097|"     This is an extension study to the first clinical study of SBC-102 (sebelipase alfa) for the     treatment of LAL Deficiency. It is an open label study in adult patients with liver     dysfunction due to Lysosomal Acid Lipase (LAL) Deficiency. This study will assess the     long-term safety, tolerability, and efficacy of SBC-102. The targeted number for this study     is 9 evaluable subjects.   "
137261|NCT01488084|"     The purpose of this study is to compare saphenous veins harvested using the atraumatic     pedicled (no-touch) technique to saphenous veins harvested using the conventional open     technique in patients undergoing isolated coronary artery bypass surgery. Investigators will     compare the biological structure of the saphenous veins harvested using these two techniques.     There is some evidence that saphenous veins harvested using the no-touch technique may     allow for better patency up to 8 years following bypass surgery. We may be able to detect     early differences in vascular structure, observed at the time of conduit harvest.   "
137262|NCT01488071|"     The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is     at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms     that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.   "
137263|NCT01488058|"     Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in     the maintenance of disorders. One specific bias is the interpretation of ambiguous     information. A negative interpretation bias is defined as a systematic tendency to interpret     potentially ambiguous information in a negative rather than benign way and this bias has been     associated with symptoms of depression. Research has led to the recent development of     computerized cognitive bias modification (CBM) techniques to augment such biases and it has     been suggested that CBM techniques may be useful as an adjunct to current treatments to     enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM     procedures lend themselves to being delivered remotely, are cost-effective, and can be     self-paced in ways that suit the patient make them an ideal candidate for inclusion in the     Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St.     Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the     current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to     the existing iCBT modules offered through St. Vincent's Hospital and the University of New     South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as     indexed by a standardized clinical battery.   "
137264|NCT01488045|"     The study aim is to determine if Propofol or the combination of Fentanyl and low-dose     Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a     colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study     is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the     participant, and the secondary outcome will be the discomfort of the patient and difficulty     of the procedure as perceived by the physician.   "
137267|NCT01488006|"     This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study     are to establish the safety, effectiveness, and value of the prosthetic system, and to     collect information from expert shoulder surgeons as to features of the implants,     instruments, and techniques which may be further improved. In this study, the investigators     hypothesize that this prosthetic device will significantly improve long-term patient-based     outcomes, functional status and quality of life.   "
137268|NCT01487993|"     The purpose of this study is to determine whether metformin is effective in reducing BMI and     insulin resistance in obese children and adolescents.   "
137269|NCT01487980|"     Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min     after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron     status until six months after birth, without increasing the risk of polycythaemia or other     adverse events. We hypothesize that this intervention will also benefit low birth weight     infants in South Africa.   "
137270|NCT01487967|"     This pilot intervention study will test the feasibility and acceptability and explore the     outcomes of an urban, primary care-based intervention to measure families' preferences and     goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical     care to reach these goals.   "
137271|NCT01487954|"     This phase II trial is studying how well alkaline water works in reducing skin toxicity in     women with breast cancer undergoing radiation therapy. Alkaline water may reduce radiation     therapy-related skin toxicity in patients with breast cancer.   "
137272|NCT01487941|"     The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead     Setrox JS.   "
137273|NCT01487928|"     Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies     show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly     affect an infant's growth. The investigators now have the ability to measure caloric density     of human milk and add human milk cream to any human milk (mother's own or donor human milk)     that is less than 20 kcal/oz to bring it up to that amount.   "
137274|NCT01487915|"     Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.      But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.      Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb)     with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred     regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.      But the grade 3 or worse toxicities associated with GCb are not infrequent and need more     effective and more tolerable regimens.      GemOx has been reported to be effective and have very favorable toxicity profiles.   "
137275|NCT01487902|"     The purpose of this study is to assess the androgen deprivation therapy when patients with     castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.   "
137317|NCT01487356|"     Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy;     however, few studies have evaluated specific factors that may influence the duration of     withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection     rate, one element of quality of colonoscopy, also need further study. By collecting data on     hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors     associated with withdrawal time, inappropriately short withdrawal times, and polyp detection     rate during colonoscopy.   "
137276|NCT01487889|"     Primary objective of this study is to examine the effects of 2 different approaches of     dietary strategies to optimise fatty acid composition in complementary food on infant's fatty     acid status and its consequences on cognitive and visual development.      Subjects are randomly assigned to one of three groups:        -  Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3          LC-PUFA metabolism)        -  Fatty fish (preformed n-3 LC-PUFA, especially DHA)        -  Corn oil (as control group, high in n-6 PUFA, common in complementary food).      The intervention starts with the beginning of complementary feeding as generally recommended     between 4 to 6 months of age and ends at the age of 10 months. For this period of time     subjects of all groups receive commercial vegetable-potato-meat-meals as part of     complementary food which only differs in the fatty acid composition.   "
137277|NCT01487876|"     In order to study the immunotherapeutic effects of electroporation (EP)-mediated     dual-plasmids Hepatitis B Virus DNA vaccine, the investigators plan to conduct a     double-blind, randomized, placebo-controlled trial, approved by Chinese State Food and Drug     Administration with written informed consent from each chronic hepatitis B (CHB) patients     with baseline ALT more than 2 times the ULN, for whom antiviral treatment is indicated and     who were under the simultaneous lamivudine (LAM) chemotherapy.   "
137278|NCT01487863|"     The purpose of this study was to evaluate the impact of concurrent versus sequential     administration of abiraterone acetate plus prednisone on the ability to manufacture     sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and     efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate     plus prednisone in men with metastatic castrate resistant prostate cancer.   "
137279|NCT01487850|"     On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the     investigators supposed that wind reed instruments could be contaminated with molds. The     investigators led a study on 40 musicians playing a wind reed instrument to analyze     instruments' fungal contamination and its immunological and clinical consequences for     musicians.   "
137280|NCT01487837|"     The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger     levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the     treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study     hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF <     13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after     start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.   "
137281|NCT01487824|"     The purpose of this study is to investigate whether early life exposures such as premature     birth or exposure to preeclampsia before you are born results in long-term alterations in the     cardiovascular system that increase risk of cardiovascular disease development.   "
137282|NCT01487811|"     This trial is conducted in the United states of America (USA). The aim of this trial is to     compare two formulations of biphasic insulin aspart 30 in healthy volunteers.   "
137283|NCT01487798|"     This trial is conducted in Europe. The aim of this trial is to investigate the difference in     frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30     compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.   "
137461|NCT01485484|"     The research at University of California Irvine, Beckman laser institute and Praxis     Biosciences Incorporation, develope near-infrared trans-illumination methods. The optical     imaging tool that can determine acute sinusitis and the response to treatment therapy.   "
137284|NCT01487785|"     This phase Ib study includes two phases: dose escalation phase and safety expansion phase.      During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and     maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225     administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase     of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for     expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or     metastatic pancreatic adenocarcinoma patients.      During the safety expansion phase, once the MTD of LDE225 is established, additional patients     will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to     further evaluate its safety, tolerability and explore the potential efficacy of the combined     treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.   "
137285|NCT01487772|"     The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture     patients with regard to in-hospital complication rate and one-year mortality and to evaluate     two different fast-track systems for hip-fracture patients with regard to patient outcome,     complication rate and patient satisfaction.   "
137286|NCT01487759|"     The purpose of this study is to investigate the influence of the prebiotic oligofructose     enriched inulin on the metabolite pattern in Crohn's disease patients.   "
137287|NCT01487746|"     The investigators expect to find higher levels of both classical and minor antiphospholipid     (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not     only classical APLA but also minor antibodies.      The investigators believe that minor antibodies have a major role in the hypercoagulability     state.   "
137288|NCT01487733|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors predict how well patients will respond to treatment.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.   "
137298|NCT01487603|"     Lung cancer is the leading cause of death in the world. Overall 5-year survival rate is fewer     than 10% and the effectiveness of conventional chemotherapy is limited. The new knowledge     shows the correlation between genetic alteration and effective of chemotherapy. Therefore     non-surgical modalities to obtain tumor specimens for genetic alteration analysis are     particularly critical in lung cancer, since many patients have advanced disease at the time     of first presentation, and are therefore not eligible for radical surgery. Endobronchial     ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples obtained during     diagnosis of lung cancer can be used for molecular analysis that will predict response to     treatment and prognosis. In this study, we will detect specific target molecules related to     the effectiveness of treatment (surgery, chemotherapy, radiotherapy) and prognosis in     patients with lung cancer using EBUS-TBNA samples and its combined with xenograft technology.   "
137289|NCT01487720|"     Prostate cancer is one of the most common malignancies affecting men all over the World.     Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25     months). Prostate cancer that grows despite castrate levels of testosterone and that no     longer responds to any form of hormonal manipulation is defined as castrate resistant     prostate cancer (CRPC).      Docetaxel combined with prednisolone has been shown to not only improve QOL and PSA response     in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not     been universally effective, and nearly all patients have disease progression after docetaxel     treatment.      After failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone, which     are not widely and easily availabe in Korea, little treatment regimen can be applied to the     patients with reasonable response and benefits.      Gemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors.     When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with     median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in     pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of     57% in patients with measurable disease.      Oxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of     activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II     study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either     alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including     cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients in     each arm.      Gemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe     and effective in various cancers.      This study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.   "
137290|NCT01487707|"     The objective of this cluster randomized controlled trial is to assess the impact of several     community-based interventions that address the key factors underlying the high maternal     mortality, as well as neonatal mortality and morbidity in northern Nigeria. The     interventions, include:        1. a Voluntary Health Worker Program (VHW)        2. the VHW program with provision of a safe birth kit        3. the VHW program with community folk media activities.   "
137291|NCT01487694|"     Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat     menopausal symptoms. To date, there are still scarce information about its efficacy in Thai     women with menopausal symptoms. The purpose of this study will assess the efficacy of black     cohosh extract in management of menopausal symptoms in Thai women.   "
137292|NCT01487681|"     Human papilloma virus (HPV) infection contributes as a main causative factor to the     development of invasive cervical cancer (ICC) and its precursors (cervical intraepithelial     neoplasia, CIN). Currently, two prophylactic vaccines are employed for the prevention of     genital HPV infection. As the prophylactic efficacy is type-restricted, determining the     type-specific HPV distribution and their associations with ICC and its precursors would     provide essential information in assessment of HPV vaccination program impact. The baseline     information is also important for monitoring possible changes in type-specific HPV     distribution after vaccination has been introduced.      Prevalence of HPV infection varies considerably across the world, and data were limited from     less-developed countries. Knowledge of the detail pattern of HPV type-specific distribution     in each region will be essential for public health policy decisions. This will also form the     basis for determining which types should be included in future generation HPV vaccines     targeted to specific regions.      While most studies were focus on ICC and high-grade cervical lesions, the association between     HPV types and the progression of CIN1 has rarely been studied. CIN1 is an insensitive     histopathological sign of HPV infection, most of which will spontaneously regress to normal     with host immune system. However, some genotypes have been described as being more persistent     and associated with progression from low-grade lesions to high-grade lesions, even ICC.     Geographical data on type-specific prevalence of HPV in CIN1 with appropriately designed     prospective studies would be helpful in identifying types preferentially associated with     progression to malignancy and accurately predicting the future impact of vaccination in     specific regions.      Free vaccination supported by the government appears to be unlikely at present in China.     Thus, individuals need to pay the cost of vaccines for themselves presently. Yangtze River     Delta Area is the most economically developed regions in China, and people here may become     the largest vaccinated population at their own expense in China. To the best of the     investigators knowledge, no multi-center study on HPV type-specific distribution and their     associations with ICC and its precursors is available in Yangtze River Delta Area, China,     which highlights the need for timely study in this region before large scale vaccination     programs are carried out.   "
137293|NCT01487668|"     Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease     (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help     promote health behavior change and improve mental health and physical health-related quality     of life, as well as to get feedback from patients and providers on what is needed to help     better coordinate the physical and mental health care of these patients.   "
137306|NCT01487499|"     This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung     cancer in two fashions:        1. to implement a prospective clinical trial to test the feasibility and efficacy of          intralesional chemotherapy as consolidative therapy immediately following standard          systemic chemotherapy and radiation therapy for patients with limited stage SCLC by          comparing tumor growth and survival rates of the treatment group and compare the          outcomes to historical controls        2. to implement a prospective clinical trial to test the feasibility and efficacy as          measured by tumor growth and survival rates of intralesional chemotherapy for patients          with recurrent SCLC after standard treatment.   "
137294|NCT01487655|"     Color Doppler Imaging (CDI) has been providing information about ocular blood flow over the     past decades. This non-invasive procedure based on ultrasound technique has identified     increased resistance and decreased systolic blood velocities to exist in the ophthalmic     arteries of glaucoma patients. However, existing data has provided very little information     regarding the analysis of the Doppler waveform in itself and to whether variables such as     early systolic acceleration or systolic/diastolic velocity ratios are of any significance in     glaucoma disease. In other medical specialties using CDI technology, such as nephrology or     cardiology for instance, this analysis has been part of the normal routine. This information     has been used in screening patients for disturbed circulation such as arterial stenosis or     providing information regarding prognosis of renal and hepatic transplants have been used for     decades now.      What is the normal characteristics of the waveform Doppler analysis? To answer this, the     investigators will create a normative database using healthy controls.      Are there signs of altered stiffness or compliance in the ophthalmic arteries of glaucoma     patients? To answer this, the analysis of early acceleration acceleration and detection of an     early peak systolic will be done on the Doppler curves of glaucoma patients and compared to     the healthy normative database.      Are there any difference between the two types of glaucoma [primary open-angle glaucoma     (POAG) and normal-tension glaucoma (NTG)]? The investigators will compare the variables of     the ophthalmic artery waveform in these two groups.      Do any of these Doppler waveform variables have any clinical significance? To answer this,     the investigators will search for the existence of any correlation between the waveform data     and both functional (visual field testing) and structural (Confocal scanning laser     ophthalmoscopy - CSLO) variables of the glaucoma groups.   "
137295|NCT01487642|"     The primary objective of the study is to compare the efficacy of four different smoking     cessation programmes, including a proactive telephone counseling intervention, a reactive     telephone counseling a and an interactive web-based intervention and (as control) written     self-help material.   "
137296|NCT01487629|"     The purpose of this study is to compare the morphological and visual acuity outcomes     associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for     treatment of diabetic macular edema.   "
137297|NCT01487616|"     Aims: We plan to investigate how common uterine malformations are in high-risk women (with     history of miscarriage or preterm delivery), by analysing different characteristics in these     groups. This study will also investigate other ultrasound characteristics detected on these     women. This study will point towards the possible mechanism of how uterine malformations may     affect pregnancy outcomes.   "
137318|NCT01487343|"     The purpose of this study is to identify what makes it easier and what makes it harder to     take oral chemotherapy.   "
137300|NCT01487577|"     Bone marrow transplantation (BMT) is used to successfully treat high-risk forms of leukemia,     lymphoma, and other childhood cancers that were once considered incurable. A major barrier to     the application of this life-saving treatment is acute graft-versus-host disease (GVHD) which     develops in approximately 30-80% of patients and is a leading cause of death from transplant     complications. Current GVHD prevention methods are not very efficacious and lead to     unacceptable side effects. Mycophenolate mofetil (MMF), an anti-rejection medication used in     solid organ transplants, has shown great promise in BMT recipients. The effectiveness of MMF     depends on blood levels of mycophenolic acid (MPA, the active form of MMF). Different     patients have been found to have different blood levels of MPA when they are given the same     dose of MMF. The purpose of this study is to study a novel method of giving MMF based on its     metabolism (pharmacokinetics) to achieve desired blood levels of MPA for prevention of GVHD.     Non-invasive ways of monitoring the drug exposure will also be studied. The ultimate goal of     this study is to improve approaches to GVHD prevention and improve outcomes of BMT in     children.   "
137301|NCT01487564|"     The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in     healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.   "
137302|NCT01487551|"     The primary objective is to study changes in disease related biomarkers in patients with     progressive SSc during treatment with ABR-215757.      The secondary objectives are to assess the safety and tolerability of ABR-215757,to assess     disease activity and quality of life (QoL)during treatment with ABR-215757 and to assess the     plasma levels of ABR-215757 during the study.   "
137303|NCT01487538|"     The purpose of this study is to compare an technology-based weight maintenance intervention     using action plans, videos discussion boards and health behavior tracking (weight, calories     in and out, pedometer steps) with a technology-based standard advice group to facilitate     health management, resourcefulness and health status for rural middle-aged women.   "
137304|NCT01487525|"     The purpose of this research study is to determine whether low intensity resistance training     with concurrent application of a peripheral blood flow restriction device to the exercising     limb will elicit increased quadriceps strength, functional gains, ability to complete     knee-related activities of daily living, mobility, and quality of life in individuals at risk     for developing symptomatic knee osteoarthritis (OA). It is known that higher quadriceps     strength is protective against developing symptomatic knee OA.1 However, people at risk for     knee OA frequently do not tolerate the high intensity resistance training that is generally     believed necessary to increase muscle strength. Partial blood flow restriction (PBFR) to the     exercising muscle has been reported to result in strength gains, while requiring lower levels     of joint loading.2 This method may be better tolerated, enabling efficacious exercise in     older adults who may not tolerate high knee joint loads.      To asses the efficacy of a 4 week low-intensity resistance training program with concurrent     application of PBFR to the exercising limbs to improve quadriceps strength and size, leg     muscle power, and mobility in individuals at risk for developing symptomatic knee     osteoarthritis,we will test the following hypotheses. In comparison with low-intensity     resistance training without use of PBFR, a four-week low-intensity resistance-training     program with PBFR will:      Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee     extensor strength      Secondary Hypotheses:        1. Increase quadriceps muscle volume assessed by MRI        2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed          stair climb        3. Not adversely effect knee pain or quality of life assessed by the Knee injury and          Osteoarthritis Outcome Score (KOOS) questionnaire   "
137305|NCT01487512|"     The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in     healthy adult Taiwanese participants after oral administration of 4 different dose strengths     of 8, 16, 32 and 64 mg under fasted conditions.   "
137307|NCT01487486|"     To the best of the investigators knowledge, exhaustive characterization of the low and high     abundant proteins and glyco-proteins of the Follicular Fluid (FF) has not yet been achieved.     Such an analysis may provide critical molecular data on the role of the FF in oocyte     maturation and may identify specific changes in the FF proteome of patients with gynecologic     problems, such as Polycystic Ovary Syndrome (PCOS).      Specific Aims        1. To perform a comprehensive analysis of normal human FF using sensitive mass spectrometry          in combination with conventional approaches for proteomic evaluation and using HPLC and          Western blot for glyco-proteomic analysis.        2. Characterize differential proteomic and glyco-proteomic patterns of the FF in normal          women compared to lean and obese women with PCOS.        3. To supplement the differential proteomic and glyco-proteomic analysis with steroid          hormone analysis in all FF samples.   "
137308|NCT01487473|"     The main purpose of this study is to determine the degree to which Mindfulness-Based Stress     Reduction, a group-based psychological therapy that includes mindfulness meditation     exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with     daily life among adult chronic pain patients.      The second purpose is to examine the role of attention in improving psychological and     physical health for chronic pain patients.   "
137309|NCT01487460|"     This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in     healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311     concentration in blood and effect of TAP311 administration on simvastatin concentration will     also be assessed in healthy volunteers.   "
137310|NCT01487447|"     The purpose of this study is to determine the efficacy of a customized sound therapy in     reducing tinnitus loudness and increasing the residual inhibition.   "
137311|NCT01487434|"     In partnership with the Chicago Public Schools (CPS), the goal of this project is to test the     effectiveness of a manualized mentoring and case management program for students in grades     1-8. Most of the current policy and research attention on dropout has focused on the dropout     decision itself, even though dropout is more likely to be simply the end point of a     longer-term developmental process. This project seeks to learn more about the relative     effectiveness of preventing dropout through mentoring and case management programs, and to     learn more about the relative effectiveness of intervening early vs. later.   "
137312|NCT01487421|"     This study is conducted in Europe. The aim of this study is investigate the potential of a     supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled     patients with type 2 diabetes in a normal diabetes care setting.   "
137313|NCT01487408|"     This study is conducted in Japan. The aim of this study is to evaluate the incidence of     severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type     2 diabetes.   "
137314|NCT01487395|"     The early assessment of new drugs for Alzheimer's disease remains difficult because of the     lack of predictive end-point. The use of a battery including different parameters could     improve this early development of new drugs. Nevertheless, the interest of such a battery     should previously be validated with the yet marketed AD drugs   "
137319|NCT01487330|"     The purpose of this first-in-human study is to assess the technical feasibility, deployment     characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and     delivery system in subjects with severe symptomatic aortic stenosis (AS).      This is a single center, prospective, non-randomized, first-in-human investigational study     without concurrent or matched controls.   "
137320|NCT01487317|"     The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in     patients aged 75 and over, hospitalized with delirium.      Study type : Interventional Study design: randomized, double-blind, placebo-controlled study     during one month and a 11-month follow-up   "
137321|NCT01487304|"     This study is conducted in Europe. The aim of this study is to verify the therapeutic effects     of low-dose hormone replacement therapy (HRT) in female patients over adequately long time     period in normal clinical practice conditions in the Czech Republic.   "
137322|NCT01487291|"     At the Thrombophilia Clinic of the Hospital Federal dos Servidores do Estado do Rio de     Janeiro there is a high prevalence of acute psychotic episodes, which allows the     investigators to raise the suspicion that the thrombotic tendency or hypofibrinolysis play a     role in the onset of the disease. It is striking that most of these patients, after some time     on anticoagulants, no longer need to take psychiatric medication.   "
137323|NCT01487278|"     This is a large, community-based, cluster-randomized trial to compare routine prophylactic     use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly     during the third stage of labor.   "
137324|NCT01487265|"     Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a     positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model     H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was     observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could     potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth     inhibition and enhancing the response to erlotinib.   "
137325|NCT01487252|"     An estimated 23 million Americans, including adolescents and the elderly, suffer from     circadian rhythm sleep disorders, such as delayed sleep phase disorder, advanced sleep phase     disorder and winter depression. These conditions are characterized by persistent insomnia     and/or excessive daytime sleepiness, impaired performance, reduced well being and lower     quality of life. The negative symptoms result from a misalignment between the timing of sleep     and the internal circadian clock. Clinical research has demonstrated that circadian rhythm     sleep disorders are most effectively diagnosed (differentiated from other causes of insomnia)     and treated if each individual patient's circadian phase is known. The timing of the master     internal circadian clock is most reliably measured from the onset of the endogenous circadian     rhythm of melatonin, a neuroendocrine hormone, as measured in dim light (dim light melatonin     onset, or DLMO). However to date the reliable and valid assessment of the DLMO is limited     to the research laboratory setting.      This study is to test a streamlined procedure for the accurate assessment of circadian phase     (DLMO) outside of the laboratory that will provide clinicians and researchers with a novel     diagnostic and research tool. In this way the underlying neurobiological cause of a patient's     insomnia and/or circadian rhythm disorder can more readily be diagnosed and treated.      Specific Aim 1 is to validate procedures for at-home circadian phase assessment in a sample     of healthy people. Validation will occur by (1) objectively measuring compliance to the     at-home procedures and (2) comparing DLMOs collected at home to DLMOs collected in the     laboratory, in a within-subjects counterbalanced design. Specific Aim 2 is to validate the     same at home procedures in patients with delayed sleep phase disorder. Specific Aim 3 is to     conduct rigorous analyses to inform future users which subject characteristics and light     levels predict (1) compliance to the at home procedures and (2) valid at-home DLMOs.      The results of this 3 year study will have substantial implications for the translation of     basic and clinical research to the community: (1) the diagnosis and treatment of insomnia and     circadian rhythm sleep disorders will be significantly enhanced, thus improving public health     and safety, mood and quality of life, (2) community participation in research will be     improved, particularly in vulnerable and under represented populations, thus increasing     scientific knowledge and (3) research and clinical costs will be substantially reduced.   "
137326|NCT01487239|"     This study will be an open-label, non-randomized, absorption, metabolism, and excretion study     of [14C]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or     surgically sterile female subjects following at least a 10-hour fast from food (not including     water).   "
137327|NCT01487226|"     Purpose Primary endpoint        -  To evaluate the 3-year disease free survival Second endpoints        -  To evaluate the 3-year & 5-year overall survival To analyze the toxicity and the quality          of life   "
137328|NCT01487213|"     The main objective of the study is to optimize the routines for follow-up after medical     abortion in order to give women more autonomy by reducing the number of consultations     involved and to reduce the frequency of postabortal curettage.      This will be achieved by providing means for women for postabortal self-assessment with the     use of a quantitative urinary hCG test.   "
137329|NCT01487200|"     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of     FX006 in patients with osteoarthritis of the knee.   "
137330|NCT01487187|"     Very preterm babies frequently develop problems with their blood circulation during the first     few days after birth. These circulation problems could affect the oxygen and blood flow to     their brain and lead to effects such as bleeding in the head or delayed developmental     milestones later in life. Currently the care for such problems may include transfusion of     intravenous fluids or blood to the baby and/or giving the baby medications that can help     circulation.      The current practice at the delivery of these babies is to immediately clamp their umbilical     cords after birth. Recent research studies have shown that giving more of the baby's own     blood to them at birth by delayed cord clamping (waiting for clamping the cord for about     30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these     babies may need later on. It may also improve their initial blood pressure and reduce the     chances of bleeding in their heads.      More research is needed to prove if either delayed cord clamping or milking the cord at birth     will be better in terms of improving these babies' health.      The aim of this study is to find out if adding some blood to these babies' circulation,     through milking the cord at birth, could prevent or reduce the possible problems with blood     circulation and the reduced blood flow to the brain that some of these babies may have after     birth.      The investigators will also investigate if milking the cord at birth could improve their     long-term developmental outcome.      Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3     times prior to clamping, compared to immediate clamping after birth will improve systemic     blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in     the first 24 hours after birth)   "
137331|NCT01487174|"     This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung     cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is     hypothesized that KD019 can prolong survival compared with erlotinib.   "
137332|NCT01487161|"     The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of FX006 in     patients with osteoarthritis of the knee.   "
137335|NCT01487122|"     This randomised controlled trial aims to compare the effect of microwave diathermy     (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain     patients. Every patient will also be treated by exercise and transcutaneous electrical     neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves     is justified in terms of pain relief or reduction of disability in this patients.   "
137336|NCT01487109|"     This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499     for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are     currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or     angiotensin II receptor blocker (ARB).   "
137337|NCT01487096|"     The primary objective of this study was to determine the safety and efficacy of teriflunomide     in multiple sclerosis (MS) with relapses.      Secondary objectives were:        -  To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI)          variables as well as clinical and quality of life measures.        -  To investigate the pharmacokinetic and pharmacodynamic relationships.   "
137338|NCT01487083|"     The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in     participants with schizophrenia.   "
137354|NCT01486875|"     This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of     serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects     with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.   "
137339|NCT01487070|"     Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal     injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy     in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary     to proliferative diabetic retinopathy.      Secondary objective is to evaluate regression of neovascularization and progression of     macular traction utilizing OCT and fundus photographs.   "
137340|NCT01487057|"     The continuous increase of the incidence of the thyroid cancer in the last years has taken     this neoplasia among the first 4 frequent cancers in the cancer registry of the Institute of     Oncology Prof.Ion Chiricuţă from Cluj-Napoca (IOCN), with a total number of over 470 new     cases per year, added to the other 3700 cases already being in the evidence of the Institute.      The radical treatment brings for a long term a compensated chronic drug induces mYxoedema     with it's important side effects. Among these one can find the dislipidemia and the change of     the high sensitive C reactive protein (hsCRP) serological value. In the last years, many     epidemiological studies have confirmed the fact that the patients with a high serological     value of the hsCRP present a higher risk for the coronary disease and heart attack.      Prospective studies developed in european countries and in USA have provided results that are     related to the predictive value of the hsCRP determinations over the cardiovascular risk.     Thus, hsCRP is an indirect risk factor for the coronary disease. The risk for cardiovascular     disease is 2 to 7 times higher at the people with a high level of hsCRP comparing to ones     with low levels; the increase of the hsCRP serological value can be determined several years     before the clinical debut of the coronary disease.      The screening for this population group with a high risk can introduce in use the prevention     of the cardiac pathology and change the approach to the monitoring of the patients with     thyroid cancer. A selection protocol will be elaborated for the patients that will withdraw     the hormone treatment by using recombinant thyroid stimulating hormone (TSH) or will have     personalised monitoring algorithm, with a shortening of the hormone treatment withdrawal.   "
137341|NCT01487044|"     Establish the efficacy of initial high frequency loading of intravitreal pegaptanib bi-weekly     during the initial treatment period when the VEGF levels are the greatest and then gradually     extending the administration frequency to monthly as homeostasis ensues for the treatment of     DME, as measured by best-corrected visual acuity.   "
137342|NCT01487031|"     Autologous stem cell transplant (ASCT) is an important therapy for patients with multiple     myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. It has been shown to improve     progression free survival and overall survival. However, it is a challenging treatment     process both physically and psychologically. It is a procedure with many side effects that     can be uncomfortable, painful, and at times, difficult to endure. Complementary therapies,     such as music therapy, have potential to be an important adjunct in palliation of symptoms in     patients undergoing chemotherapy.   "
137343|NCT01487018|"     Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex     can be considered a formidable challenge, even to the skilled surgeon. However, the     development of Computer-Assisted Navigation technology Offers new opportunities in the     treatment of such deformities. With the help of navigation system,pre- and     intraoperatively,the objective of any supporting medical device for reconstruction of the     orbitozygomaticomaxillary complex would be visualization of the real and desired positions of     the zygoma. In this randomized controlled trial, the investigators would like to evaluate the     feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in     cases of established post-traumatic deformities using computer assisted navigation.   "
137344|NCT01487005|"     The Multicenter Ozone Study in Elderly Subjects will investigate whether short-term exposure     of elderly volunteers to ambient levels of ozone in a controlled exposure setting causes     acute cardiovascular responses as assessed by changes in blood pressure, cardiac function,     and systemic biomarkers of inflammation, endothelial dysfunction, and thrombosis.   "
137345|NCT01486992|"     There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some     showed that irinotecan may be effective. The investigators previous study has shown the     efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study,     the investigators would like to observe the efficacy and safety of Nimotuzumab plus     Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of     PTX/DDP.   "
137346|NCT01486979|"     This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of     systemic absorption of estradiol during treatment with two different doses of estradiol in     postmenopausal women with atrophic vaginitis.   "
137418|NCT01486043|"     The purpose of this study is to determine whether metformin is an effective adjunctive     treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (ALL)     undergoing induction chemotherapy   "
137347|NCT01486966|"     This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of     insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a     basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.      The trial adopts a group sequential design, where the analysis of the primary efficacy     endpoint will be performed at the interim analysis, in addition to the final formal analysis.     The decision to continue or stop the trial will be based on the result of the interim     analysis.   "
137348|NCT01486953|"     The aim of the current study was to compare the effects of sevoflurane and desflurane on     respiratory mechanics in patients undergoing repair of pectus excavatum.   "
137349|NCT01486940|"     This trial is conducted in Europe and South America. The aim of this trial is to compare the     glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human     soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.   "
137350|NCT01486927|"     This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study     comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period     (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety,     efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects     enrolled in Parts 2 and 3.   "
137351|NCT01486914|"     This trial is conducted in Europe. The aim of this trial is to compare insulin aspart     produced by current process and the NN2000 process.   "
137352|NCT01486901|"     This trial is conducted in Europe. The aim of this trial is to test for bioequivalence     between two formulations of Insulatard® in healthy subjects.   "
137353|NCT01486888|"     This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence     between two formulations of Mixtard® 30 in healthy subjects.   "
137356|NCT01486849|"     A Phase II, double-blind, randomized, placebo-controlled ascending dose titration study to     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple     ascending doses of CK-2017357 to an individual patient maximum tolerated dose (MTD), using a     within-patient twice daily (BID) dose-titration regimen in ALS patients on 50 mg riluzole     once daily (QD).   "
137357|NCT01486836|"     The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox     DX system.      No hypothesis has been defined.   "
137358|NCT01486823|"     This is a study in healthy volunteers designed to investigate the PK following intravenous     and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of     MLDL1278A after subcutaneous administration will be determined.   "
137359|NCT01486810|"     The proposed protocol is an open-label pilot study of the treatment of cocaine dependence     using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12     patients in an eight-week open-label trial to obtain preliminary data regarding the safety,     tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence     and to determine an effective dosage range.   "
137360|NCT01486797|"     The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination     with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously     treated patients with chronic lymphocytic leukemia (CLL).   "
137361|NCT01486784|"     This is a phase I/II, open-label non-randomized study using an investigational new drug,     TL32711, in patients with AML, MDS and ALL. This study will target subjects 60 years of age     and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or     who are newly diagnosed )and subjects 18-59 (relapsed or refractory after failing 3 prior     lines of therapy). This study will also target subjects 18 years of age and older with MDS     and ALL.   "
137362|NCT01486771|"     Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic     Retinopathy (PDR) and reduce the need for retinal photocoagulation.   "
137363|NCT01486758|"     This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical     effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial     Virus (RSV) bronchiolitis.      HYPOTHESES      In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo)     will result in:        1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum          and nasal wash measured on day 8 after randomization.        2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks          3-52 following randomization.   "
137364|NCT01486745|"     This is a prospective, multi-centered study to assess whether urine metabolomics can play a     role in the screening of colorectal cancer (CRC). Urine samples will be collected from 1000     patients going through an established CRC screening program, and from a further 500 patients     who already have a diagnosis of CRC. Using nuclear magnetic resonance (NMR) spectroscopy, the     1H NMR spectrum of urine samples will be analyzed for specific metabolites, and establish the     metabolomic signature of colorectal cancer. The results from metabolomic urinalysis of this     screening cohort will be compared with results from colonoscopy, histological descriptions,     fecal occult blood testing (FOBT), and fecal immune testing (FIT) to assess the accuracy of     urine metabolomics in identifying patients with polyps and malignancies. The urine     metabolomic results from the colorectal cancer group will be correlated with operative,     histological and clinical staging to define the role of urine metabolomics in assessing     colorectal cancer type, location and stage. Additionally approximately 300 urine samples from     breast cancer patients and 300 from prostate cancer patients will be collected to validate     that the colorectal cancer signature is unique.   "
137365|NCT01486732|"     This is randomized placebo-controlled trial to recognize new cell regeneration in the brain     using FLT-PET.   "
137366|NCT01486719|"     Sensory reconstruction of the finger pulp is a challenging problem. This article reports     repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches     of the proper digital nerves (PDNs) were used for maximal sensory restoration.   "
137419|NCT01486030|"     Acute exercise such as in exercise stress test would affect the peripheral gene expression     levels of the 23 genes in the CORUS CAD algorithm and the time frame.   "
137420|NCT01486017|"     The purpose of this study is to determine the relative bioavailability and pharmacokinetic     profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the     safety and tolerability after a single dose of three different strengths of a new tablet     formulation.   "
137367|NCT01486706|"     Overactive bladder (OAB) syndrome as defined by International Continence Society is a     pathological condition characterized by irritative symptoms: urinary urgency, with or without     incontinence, urinary frequency and nocturia. The syndrome often seriously compromises the     quality of life of the patients. The etiology of the OAB is considered multifactorial. Neural     plasticity of bladder afferent pathways is one of the proposed mechanisms of OAB. The     detrusor muscle itself has for many years been the target for drug treatment such as     antimuscarinics. However, depression of detrusor contractility, may results in a reduced     ability to empty the bladder and lead to some sympathetic adverse effects, which limits the     treatment of OAB. Currently the focus of OAB treatment has changed to other bladder     structures/mechanisms, such as afferent nerves and urothelial signaling as targets for     intervention. C-fiber bladder afferents nerves may be critical for symptom generation in     pathologic states such as OAB because these fibers demonstrate remarkable plasticity.     Up-regulation of bladder C-fiber afferent nerve function may also play a role in urge     incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of Gabapentin's     action for neuropathic pain has not been fully elucidated but is appears to have inhibitory     activity on afferent C-fibers nerve activity; moreover, several studies had established the     safety of Gabapentin in its treatment of different conditions. Due to the proposed mechanism,     the investigators suggest that Gabapentin may be a new alternative for treating OAB.   "
137368|NCT01486693|"     The purpose of this study was to evaluate long term efficacy and safety of topical     ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis.   "
137382|NCT01486511|"     Major surgery is associated with a postoperative hypercoagulable state related to the     surgical trauma that may lead to thromboembolic complications. To the investigators     knowledge, only two series have reported the risk of PE after liver surgery with an incidence     of up to 6.3% The purpose of this study is to identify the independent risk factors     associated with the development of PE after elective liver surgery.   "
137482|NCT01485211|"     The purpose of this study is to evaluate the corneal pachymetric variations during and after     corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and     hypo-osmolar riboflavin solution in thin corneas.   "
137369|NCT01486680|"     Type 2 diabetes (T2DM) and obesity are becoming increasingly common in New Zealand (NZ) and     worldwide. Both are associated with a risk of early mortality (death). Whilst weight loss     surgery is known to be effective for weight loss, current research suggests that it may also     be effective in resolving T2DM in around 60-80% of patients, with some no longer requiring     their medication. The mechanism for this remains unclear.      Two main types of weight loss surgery are performed in NZ public hospitals, which include     gastric bypass and sleeve gastrectomy. The gastric bypass is a more complex procedure     compared to the sleeve gastrectomy. Whilst both appear to be effective for weight loss (with     most patients losing more than 60% of their excess weight), it is still not known which one     is better for treating T2DM.      This study will therefore compare which of these two surgical procedures is most effective at     treating T2DM in obese patients, as well as comparing whether there are any differences in     the amount of weight lost, side effects and quality of life.   "
137370|NCT01486667|"     Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical     practice, and share a number of symptoms and clinical features. It has been shown that     hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and     adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the     time-course and effect of treating subclinical hypothyroidism in OSA patients on the     respiratory events during sleep is not known.      Subclinical hypothyroidism is associated with an increased risk of coronary heart disease     (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of     thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum     high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of     levothyroxine is controversial.      This project will help us to know if the treatment of subclinical hypothyroidism will improve     the symptoms and reduce the progression of OSA, which may improve patients' quality of life     by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases,     etc.) or may even reduce mortality.It will help us to know the effect of subclinical     hypothyroidism treatment on of lipid profiles and hs-CRP.   "
137371|NCT01486654|"     The purpose of this study is to evaluate the effectiveness of small amounts of electrical     current, applied without surgery to the brain, in combination with speech-language treatment,     on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the     comprehension and expression of spoken and written language) following a stroke.   "
137372|NCT01486641|"     The purpose of this study is to determine whether the anterolateral in comparison to     posterolateral approach to the hip arthroplasty gives an equal or better clinical results.   "
137373|NCT01486628|"     It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose     escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in     healthy volunteers.      Objectives are to determine:        1. the maximal tolerated dose of SC ND-0612        2. the steady state plasma concentration of LD and CD following SC ND-0612 administration.      Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential     manner.   "
137374|NCT01486615|"     Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and     thus paradoxically increases episodes of arousal during sleep and thus causes restlessness     and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the     perception of sound sleep in the perioperative period.      Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will     be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of     0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P),     approximately 90 minutes before surgery.   "
137406|NCT01486199|"     The investigators are developing a new nuclear medicine imaging technique for measuring     liquid absorption in the airways that can be applied to screen new medications being     developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the     small molecule radiopharmaceutical Indium 111-DTPA will indicate changes in liquid absorption     in the airways and demonstrate whether new CF medications will be effective. In this study     the investigators will further develop this technique through testing involving pediatric CF     patients and healthy control subjects.   "
137375|NCT01486602|"     This phase I trial studies the side effects and the best dose of hypofractionated radiation     therapy when given together with chemotherapy in treating patients with stage III non-small     cell lung cancer that cannot be removed by surgery. Hypofractionated radiation therapy     delivers higher doses of radiation therapy over a shorter period of time and may kill more     tumor cells and have fewer side effects. Drugs used in chemotherapy, such as paclitaxel and     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the     cells, by stopping them from dividing, or by stopping them from spreading. Giving     hypofractionated radiation therapy together with chemotherapy may kill more tumor cells.   "
137376|NCT01486589|"     The aim of the study is to test the hypothesis that impaired cardiac autonomic function     predicts adverse outcome in unselected patients presenting in the emergency ward.   "
137377|NCT01486576|"     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential     nephrotoxic and examine the effects on the circulation and kidneys during administration of     HES during surgery.   "
137378|NCT01486563|"     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential     nephrotoxic and examine the effects on the circulation and kidneys during administration of     HES during surgery.   "
137379|NCT01486550|"     The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential     nephrotoxic and examine the effects on the circulation and kidneys during administration of     HES during surgery.   "
137380|NCT01486537|"     The aim of this study is to evaluate the level of acidity of blood samples that are been     taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures. Our     hypothesis is that samples from teeth undergoing pulpectomy would be acidic while samples     from teeth undergoing pulpotomy would bo neutral.   "
137381|NCT01486524|"     The overall purpose of the study is to determine whether either of the Improved Response     Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in patients     with severe sepsis and high risk of death. This will be an international, multicenter,     prospective-retrospective, nonrandomized, controlled, outcome-blinded, genotype-blinded,     matched-patients study. No prospective enrollment or treatment of patients will occur under     this protocol. Retrospectively collected clinical data and DNA samples will be analyzed for     existing cohorts of patients with severe sepsis who were previously treated with DrotAA     (treatment group) or not (control group) as part of their standard care in an ICU.   "
137435|NCT01485822|"     The purpose of this study was to assess the pigmentation in the trabecular meshwork of     patients who had been treated for at least 2 years with TRAVATAN compared with patients     without exposure (or less than 1 month) to a prostaglandin analogue (PGA).   "
137383|NCT01486498|"     Grass pollen and house dust mites (HDM) are the most common allergens causing allergic     rhino-conjunctivitis (RC) and/or asthma (A). Subcutaneous allergen specific immunotherapy     (SCIT) reduces symptoms and use of medication. The purpose of SABAL is to assess the effect     of SCIT on disease severity classifications in terms of number of days affected- and sick     days on patients with grass pollen and/or HDM induced disease. These outcome measures will be     gathered in one single measure: Quality Adjusted Life Years (QALY)   "
137384|NCT01486485|"     Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is     known to be an independent risk factor for mortality. Renal replacement therapy (RRT) is the     mainstay of supportive treatment of patients with severe acute kidney injury. The goal of RRT     is to achieve adequate correction of uremia, electrolyte abnormalities, and volume overload     while ensuring good hemodynamic tolerance. The advantages of continuous renal replacement     therapy (CRRT) are increased time-averaged dialysis dose, less hemodynamic instability, and     possibly, removal of high molecular weight solutes, such as inflammatory cytokines. Solute     removal can occur by several different mechanisms in CRRT. For relatively small solutes, the     importance of diffusion and convection is emphasized, for solutes of larger molecular weight,     the importance of convection and adsorption is emphasized. The ability of a specific CRRT to     remove a certain solute is determined by membrane characteristics. But actual measurements of     middle molecule clearance in large clinical trials have not been available in most trials.      During CRRT, blood is conducted through an extracorporeal circuit, circuit clotting is a     major problem in daily practice of CRRT, increasing blood loss, workload, and costs. Early     clotting is related to bioincompatibility, critical illness, vascular access, CRRT circuit,     and modality. Therefore, one major intervention to influence circuit survival is     anticoagulation. However, systemic anticoagulation, usually with heparin, can produce     hemorrhagic complications in patients at high risk of bleeding. To minimize the risk of     bleeding, a number of alternative regimens has been proposed, however, each of those methods     has its own limitations and complication. Nafamostat mesilate, a serine proteinase inhibitor,     while inhibiting various clotting factors in filter circuit, is characterized by short half     life resulting in little systemic anticoagulation effect. A recently developed CRRT AN69ST     membrane® (Gambro Inc) is coated with a polyethylene imine (PEI, cationic biopolymer) on the     membrane surface. Once adsorbed onto the membrane, heparin keeps its anticoagulant     properties. Therefore CRRT has been managed without systemic administration of heparin.      The investigators will conduct a multicenter prospective randomized controlled open-label     trial which compares the difference in circuit survival between between nafamostat infusion     and heparinized saline priming as anticoagulation for CRRT. The primary end-point of this     study is circuit survival, the time of 1st membrane exchange. The secondary end-point is     clearance of small molecule (urea) and middle molecule (β2 microglobulin) at 0, 1, 6, 24h,     ACT(activated coagulation time) measurements after 1hr of the CRRT, Hemorrhagic complication.     This is a noninferiority trial. The aim is to demonstrate that nafamostat infusion is not     inferior to the heparinized saline priming. For this purpose, at least 80 subjects (a total     of 160) would be required for each group if type I error rate is 5% and type II error is 20%     given 20% of drop-out rate during the study period. Block randomization will be used by means     of a dedicated website.      There are still conflicting data on the effective exchange time of circuit membrane. Our     study may help to improve prognosis in patients with severe AKI.   "
137385|NCT01486472|"     S-1 is an effective drug in gastric cancer (GC) for palliative chemotherapy in Eastern and     Western patients. Recently, S-1 has been also reported to be an effective adjuvant therapy     for GC patients who received D2 surgery in Eastern Asian patients.      Recently, the development of lacrimal drainage obstruction (LDO) caused by S-1 has been     reported from some case and small-sized studies. The incidence of developing LDO has been     estimated to about 15~20% of patients receiving S-1 therapy in some retrospective studies.     However, there is no prospective report on the incidence of LDO in patients receiving S-1     chemotherapy. Moreover, the mechanism of developing S-1-induced LDO has not been systemically     studied until now. Suggested mechanism of LDO involves direct secretion of S-1 into the tear.      Therefore, this study was initiated to prospectively investigate the incidence of LDO in GC     patients receiving adjuvant S-1 chemotherapy. In addition, the correlation between the     development of LDO and the concentration of S-1 (or its metabolites) in tear and plasma will     be explored. These results will help clinicians identify patients who are at high risk of     developing S-1-associated LDO.   "
137386|NCT01486459|"     Small cell lung cancer is an aggressive neuroendocrine tumour that often presents with     extensive (metastatic) disease. Chemotherapy is the mainstay of treatment, with radiotherapy     to the primary tumour. It is now part of care to also offer Prophylactic Cranial Irradiation     (PCI) in order to prevent spread of the cancer into the brain.      Cognitive impairment can result after cranial irradiation. Lithium is thought to be     neuroprotective. It is hypothesized that lithium administration with PCI will be safe,     tolerable and feasible, and can be studied to prevent or ameliorate the ensuing cognitive     impairment.   "
137387|NCT01486446|"     This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel     group study with XPF-002 applied twice daily over 14 or 21 days in patients with     Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether     XPF-002 is safe and effective in the treatment of pain caused by IEM.   "
137388|NCT01486433|"     The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty     acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.   "
137389|NCT01486420|"     The purpose of the study is to investigate which strategy is superior in trigger finger     Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid     injections.   "
137390|NCT01486407|"     This study will evaluate using intraosseous vascular access and intravenous vascular access     to give patients the necessary medications to perform rapid sequence intubation, for patients     with airway difficulties. The investigators think the device operator will find the     intraosseous and intravenous routes equal for drug delivery.   "
137391|NCT01486394|"     The purpose of this study is to determine whether focused sonography of the heart, lungs and     deep veins can increase the number of patients with respiratory symptoms correctly diagnosed     in an emergency department.   "
137392|NCT01486381|"     This trial is conducted in South Africa. The aim of this trial is to investigate Long term     safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in     trial BIAsp-1240.   "
137394|NCT01486355|"     Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early     two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality     compared with the WHO strategy of one dose of MV at 9 months.      Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the     standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of     age1. As in a previous trial it is expected that the beneficial effect is strongest for     girls.      Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles     antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than     children receiving MV at 4 months with no detectable MatAb.      Implications: These hypotheses are based on a previous RCT showing strong beneficial effects     of providing an early measles vaccine, in particular among children with MatAb.   "
137395|NCT01486342|"     Despite decades of research, the mortality in acute lung injury remains very high and     treatment options are very limited. Given these facts, the best treatment modality may be in     prevention of this lethal syndrome.      Historically, imaging has played a crucial role in understanding ALI. The appearance of chest     radiography is one of the consensus criteria in defining ALI, and commuted tomography (CT)     scans further advanced the understanding of the pathoanatomy of ALI. While valuable, these     imaging modalities are nonspecific and do not incorporate functional cellular physiology.      PET imaging measures concentrations of radioisotopes in the body. By embedding in, but not     altering molecules, the natural fate of these tracers can be studied with PET imaging.     Advances in the understanding of ALI include blood flow distribution, as well as the response     to alveolar recruitment maneuvers and prone positioning. Not all patients who are receiving     mechanical ventilation develop ALI. Inflammation in the lungs is known to play a key early     role in the development and progression of ALI. Secondary to inflammation, the lungs develop     edema and do not exchange oxygen as well. This early inflammation is in part driven by a     specific type of immune cell called the neutrophil. These cells seem to travel and become     sequestered in the lung- they are recruited to the lung during this inflammatory stage.     When there, these neutrophils release inflammatory substances which are integral in the     development of ALI. Neutrophils use primarily glucose as a fuel source. The radio isotope     [18F]Fluorodeoxyglucose (FDG)is a glucose analog and therefore taken up/ingested by the     neutrophils as a part of their normal metabolism. Because of this fact, positron emission     tomography (PET) using the radio isotope [18F]FDG is a highly sensitive marker to look at the     recruitment of neutrophils to the lung, therefore quantifying the degree of pulmonary     inflammation prior to the development of ALI.      The investigators seek to examine the relationship of pulmonary inflammation in patients at     risk for ALI, but without clinical evidence of the syndrome. The investigators seek to enroll     ten patients in a pilot trial.   "
137396|NCT01486329|"     First-in-human phase I dose escalation study in patients with locally advanced, inoperable     and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the     investigational VEGFR-2 DNA vaccine VXM01 to examine safety and tolerability, clinical and     immunogenic response to the investigational vascular endothelial growth factor receptor 2     (VEGFR-2) DNA vaccine VXM01, and to define the maximum tolerated dose.   "
137397|NCT01486316|"     The purpose of this study is to characterize the feasibility and impact of a diagnostic tool     that may help clinicians identify when patients are at higher risk of visiting the hospital     for a heart failure event. The study will use a non-experimental device that is inserted just     under the skin of the chest, which continuously monitors the heart rhythm in combination with     an experimental web-based heart failure risk status. Patients with atrial fibrillation and     heart failure will be evaluated to collect data about the potential of this risk status to     help improve patient outcome.   "
137398|NCT01486303|"     Facial Cosmetic Acupuncture technique includes wrinkles, acupoints and muscle points on the     face, head and neck. This study is designed to determine the efficacy and safety of Facial     Cosmetic Acupuncture on skin rejuvenation.   "
137399|NCT01486290|"     The purpose of this study is to find ways to identify barriers that affect self care in older     adult with diabetes and to provide cost effective coping strategies to improve clinical,     functional and psychosocial measures.   "
137400|NCT01486277|"     The purpose of this study is to determine the overall cutaneous response rate (participants     who achieve a complete response or partial response) based on the modified severity weighted     assessment tool criteria.   "
137401|NCT01486264|"     This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals     (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the     response to treatment is comparable in both how it works and any side effects. Xeomin® is     approved by the United States Food and Drug Administration (FDA) for the treatment of     cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment     intervals. An investigational use is one that is not approved by the FDA.   "
137402|NCT01486251|"     The purpose of this study is to evaluate and quantify the dynamic modifications of tumor     blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of     Axitinib.   "
137403|NCT01486238|"     Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic     Macular Edema (DME), as compared to injections every 6 weeks.   "
137404|NCT01486225|"     The purpose of this study is to identify the nature of skin lesions that develop on contact     with the grip-top bands of medical compression stockings, which are composed mainly of     silicone.   "
137405|NCT01486212|"     Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms     metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their     structure can react with other molecules resulting in cell damage. This damage is due to     several mechanisms.      This is e.g what happens when human tissue is cut of from blood supply for a time, and the     blood supply is again restored. The damage following the restoration of blood is known as     ischemia-reperfusion injury. The reopening of the vessels and thereby supplying oxygenated     blood to the deprived tissue can in it self contribute to cell death due to excessive amounts     of free radicals. Antioxidants can neutralize free radicals and thereby minimize their     damage.      The purpose of the investigators methodology study is to make an ischemia-reperfusion model     on healthy volunteers (on the lower limb) to examine the expression of markers that are     expressed in the muscle and the blood when blood supply is cut of to an area and later     restored. The investigators wish to measure the product of the damage caused by free radicals     and the levels of antioxidants.      If the investigators can produce elevation of oxidative and inflammatory markers, this model     can be used to test antioxidative intervention.   "
137407|NCT01486186|"     The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine     for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).   "
138059|NCT01477684|"     The purpose of this study is to perform a descriptive, content-based analysis on the     different forms of documentation for in-flight medical emergencies that are currently     provided in the emergency medical kits on board commercial airlines.   "
137409|NCT01486160|"     This study will be conducted in a 208-bed nursing home in Maribor. The investigators will     observe a group of a 100 nursing-home residents and 50 health care workers- employees in the     nursing home- in a six months period.Influenza vaccination status will be recorded in all     participants at the beginning.      At the beginning and at the end of the study the blood samples for vitamin D concentration     determination and nasopharyngeal swabs for molecular detection of respiratory viruses will     taken in all of the participants.      The study will observe number of viral respiratory tract infection in participants and     identify the viral etiology of infections during 6 months observational period.Nasopharyngeal     swab and blood sample will be taken in each of the participant who will suffer an acute     respiratory tract infection (upper or lower respiratory tract infection) and viral agents of     respiratory tract diseases will be searched for. The investigators will try to detect     different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses,     influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human     metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time     polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in     nasopharyngeal swab and in blood sample of the participants.      During the study period the investigators will monitor the daily number of visitors (adults,     preschool children and pupils) in each nursing home room. The epidemiological aspect of     respiratory viral infection will be assessed.      Our study hypothesis is that lower respiratory tract infections in elderly can be caused by     viruses other than influenza.      The investigators would like to know if hypovitaminosis D is a risk factor for respiratory     tract infections in nursing home residents and employees.      The investigators would also like to know if the number of respiratory tract infections in     elderly correlates with the number of visitors in nursing home, small children in particular.   "
137410|NCT01486147|"     The objective of the study is to validate a visual method of presenting nutritional     information by determining if users of the visual method remember food properties better than     users given the same information in a non-visual form with texts and tables.   "
137446|NCT01485679|"     The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in     identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will     be compared to those obtained by the pathological analysis of the removed piece of pancreas.   "
137447|NCT01485666|"     The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management     Kit for HeartMate II driveline stabilization and exit site management.   "
137768|NCT01481493|"     The study is conducted in order to find out if repeated doses of the monoclonal (artificially     manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently     respond to a treatment with methotrexate (MTX).   "
137411|NCT01486134|"     Object of the study:      To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular     carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of     reduction of the number of procedure required to obtain complete ablation of the tumors.      Experimental plan :      This pilot study consist to perform in a single center a single procedure of the multipolar     RF ablation under MR temperature monitoring for the treatment of up to three HCC with     diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion     of the study will be the rate of complete ablation one month after one RFA procedure     performed under MR temperature monitoring. The secondary criteria are, the 2-years local     recurrence rate (after the first initial RF ablation procedure performed under MR temperature     imaging ± additional RF ablation procedures under ultrasound monitoring in case of remnant     viable foci of tumor), the potential reduction of the number of RF procedures required to     achieve complete necrosis and the complication rate of RF ablation procedure performed under     MR temperature monitoring.      In exploratory attempt, the study will include comparative assessment of these criteria with     a historic leg of patients previously treated by the same operator in the same center for     similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.   "
137412|NCT01486121|"     Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in     Intensive Care Unit (ICU). That is called  sedation  and aimed to reduce both pain and     anxiety and also to allow an effective and atraumatic mechanical ventilation. However,     sedation excess and ventilator support excess, both in duration and intensity, are associated     with an excess morbidity. Patients usually are systematically sedated after having been     intubated. Then, sedation is stopped first before ventilator support is weaning. Several     studies shown that rationalized protocols of sedation and ventilation orderings had a     beneficial impact on non surgical patients' outcome. Feasibility of these protocols in     surgical patients is still unknown. Moreover, no study has evaluated an optimized paired     strategy of sedation-ventilation based on the priority setting of ventilation. This priority     setting of ventilation should increase patient's comfort in spite of increasing sedatives and     analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and     intensity of these treatments could improve surgical patients' outcome in ICU.   "
137413|NCT01486108|"     Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo     controlled pilot study burst stimulation seemed superior to tonic stimulation over a period     extending more than 2 years, and even though an incidental finding, this design seemed     capable of suppressing pain without mandatory induction of paresthesias. This permits for the     first time to scientifically prove that spinal cord stimulation is better than placebo     stimulation. A study was therefore initiated to find out whether spinal cord stimulation is     indeed capable of suppressing neuropathic limb pain in a placebo controlled way.   "
137414|NCT01486095|"     Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double     stent technique is used) is associated with a higher risk for stent thrombosis. Different     factors may play a role in the higher risk for stent thrombosis in bifurcation lesions.     Possible mechanisms are delayed endothelialisation due to the action of the drug, coating     polymers, or overlapping stent segments, incomplete stent apposition at specific sites in the     bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation site.     In human pathological data, the RUTSS (ratio of uncovered to total stent struts) appears to     be the most powerful predictor of stent thrombosis.      This prospective study will assess the differences in stent strut coverage and stent strut     apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus     A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus     A9-eluting stents in the distal main vessel and the side branch versus treatment with the     culotte technique using the Xience Prime everolimus-eluting stents.   "
137415|NCT01486082|"     Due to the high rate of resistance to clarithromycin in our area the investigators proposed     an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in     order to improve the rate of eradication.   "
137416|NCT01486069|"     The present study intends to clarify whether there is positional mandibular stability in     patients to be submitted to orthognathic surgery. In case of any instability exists, it is     needed to understand if this could be related to a particular type of dentofacial deformity     or could have any short-term or long-term influence on outcomes of the orthognathic surgery.   "
137421|NCT01486004|"     The purpose of this study is to investigate the effect of steady-state concentrations of     TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and     norethindrone (administered once a day) and on the levels of progesterone, luteinizing     hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol     and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen.     Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen     will be studied. Steady-state is a term that means that the drug has been given long enough     so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is     being investigated for the treatment of chronic hepatitis C virus (HCV) infection.     Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the     body and eliminated from the body. A contraceptive is a method that prevents pregnancy.   "
137422|NCT01485991|"     The purpose of this study is to demonstrate the efficacy of TMC435 in combination with     peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority     compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously     failed PegIFN.   "
137423|NCT01485978|"     This is a phase III, multi-centre, randomised, placebo-controlled, patient and     investigator-blind study in paediatric patients with early stages of Alport syndrome to     assess the safety and efficacy of the ACEi ramipril in slowing disease progression.      Alport syndrome stages that describe the extent of renal damage and loss of function are     defined as:        -  0 Microhaematuria without microalbuminuria (usually at birth)        -  I Microalbuminuria (30-300 mg albumin/gCrea)        -  II Proteinuria >300 mg albumin/gCrea        -  III > 25% decline of normal renal function (creatinine clearance)        -  IV End stage renal failure (ESRF)      Eligible patients with Alport stages 0 and I will be randomly assigned at a 2:1 ratio to     receive once daily ramipril or placebo. In addition, Alport stage II patients may be treated     open Label. Eligible patients who, or whose parents/legal guardian refuse randomisation after     eligibility is confirmed, and patients who have been treated with ramipril prior to the     study, may be treated open-label with ramipril as per protocol. The total number of patients     will not exceed 120, with the number of randomised patients not exceeding 60, and the number     of patients treated open label from Day 1 of the study aimed to be approximately 60.      Randomised patients whose disease progresses to the next disease level during the 3 year     treatment period will be unblinded, and open label ramipril treatment will be initiated and     continued, respectively, depending on prior treatment randomisation.   "
137424|NCT01485965|"     The primary purpose of this study is to assess the effect of food upon the pharmacokinetics     (PK) of SEN0014196 in subjects with Huntington disease (HD).   "
137425|NCT01485952|"     The primary objective of this study is to provide biological samples from patients with     Huntington's disease to allow characterisation of the pharmacological mechanism of action of     SEN0014196.   "
137426|NCT01485939|"     The investigators hypothesized that application of a 5% lidocaine patch would be associated     with reduced pain scores after operation compared with placebo patch in patients undergoing     laparoscopic cholecystectomy.   "
137427|NCT01485926|"     The primary objective:      -To assess the efficacy of TCH and TCHL in neo-adjuvant treatment of HER-2 positive breast     cancer, using pathological complete response (pCR) as the primary endpoint (Phase II).      Secondary objectives:        -  To assess the clinical response rate and overall response rate for docetaxel and          carboplatin with trastuzumab alone or trastuzumab combined with lapatinib in HER-2          positive breast cancer.        -  To assess the relationship between drug exposure and adverse events.        -  To examine potential molecular and pharmacological markers of response to trastuzumab          and lapatinib        -  To assess Disease-free Survival (DFS) and Overall Survival (OS)        -  To determine if prophylactic Loperamide significantly reduces the number of diarrhoea          -related adverse events.   "
137428|NCT01485913|"     The project will test the implementation of a specific methodology for education of type 2     diabetic patients that will be set up using patients involved (peer educators) and 3 guides     developed specifically for the therapeutic education of type 2 diabetic patients. This     project will take place in 1 sites in mali : the capital Bamako. 75 diabetic patients will be     subjected to intervention with this methodology and 75 other diabetic patients will be the     control group. At various stages of the project, the investigators will analyze the impact on     biological, anthropological constants, etc ... of the group undergoing the intervention     compared to the control group.   "
137429|NCT01485900|"     Primary Objective:        -  To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in          patients with moderate chronic kidney disease (CKD) on stable angiotensin converting          enzyme-inhibitor (ACE-I)      Secondary Objectives:        -  To assess in patients with moderate CKD the effect of concomitant multiple dose of          SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate        -  The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to          ACE-Is (AcSDKP)        -  The pharmacokinetic profile of repeated oral administration of SAR407899A during          co-administration of ACE-Is   "
137430|NCT01485887|"     This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete     the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate     in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase.     The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication     dosing.   "
137431|NCT01485874|"     The purpose of this trial is to determine whether BIBF 1120 can be safely combined with     pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the     combination in patients with platinum-resistant ovarian cancer (phase II).   "
137432|NCT01485861|"     This multicenter, international, Phase Ib/II trial consists of two stages: a Phase Ib,     open-label stage in which the recommended Phase II dose will be determined for ipatasertib     and GDC-0980 in combination with abiraterone and prednisone/prednisolone and a Phase II,     3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and     prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.   "
137518|NCT01484743|"     The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters.     The aim of present study is to use large-scale data from DVHD to uncover risk factors for     readmission, reoperation (any indication), death and reoperation for recurrence after     parastomal hernia repair.   "
137433|NCT01485848|"     Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial     benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare     the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in     patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any     significant changes in the safety profile of weekly paclitaxel alone compared to the doublet     combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this     new drug combination.   "
137434|NCT01485835|"     The purpose of this study is to find out what effects, good and/or bad, that ganetespib and     bortezomib has on you and your cancer. The investigators will determine the side effects of     different dose levels of ganetespib when given alone and the effect it has on your cancer     alone. The investigators will also determine the side effects of ganetespib at different dose     levels when given in combination with bortezomib and the effect the combination has on your     cancer. The study will measure levels of the drug in your blood and bone marrow as well.      Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration     (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is     Velcade®.      Ganetespib is considered investigational because it has not received approval from the Food     and Drug Administration for general use, although it has been previously tested in humans.   "
137436|NCT01485809|"     Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI)     approved for the treatment of advanced non-small cell lung cancer (NSCLC). Results from two     randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was efficacious and less     toxic, compared with previous results, than was chemotherapy in patients with     previously-treated non-small-cell lung cancer. Two phase III trials of gefitinib in advanced     non-small-cell lung cancer followed on from the IDEAL phase II studies: Iressa Survival     Evaluation in Lung cancer (ISEL) and Iressa NSCLC Trial Evaluating REsponse and Survival     versus Taxotere (INTEREST). Although the phase III ISEL trial failed to prove the superiority     of gefitinib treatment compared to placebo in previously treated patients, a subgroup     analysis demonstrated improved survival in particular populations (Asians and non-smokers).     The INTEREST study compared an EGFR tyrosine kinase inhibitor with chemotherapy in pretreated     advanced non-small-cell lung cancer. In INTEREST, survival was similar for gefitinib and     docetaxel in almost all subgroups; no EGFR-related biomarker or any clinical factor     (including female sex, adenocarcinoma histology, never-smoker, and Asian ethnicity) appeared     to be predictive of a greater survival benefit for gefitinib versus docetaxel. However, these     factors may still be predictive of a greater survival benefit for gefitinib and/or docetaxel     versus best supportive care; alternatively, they may just be good prognostic factors.     Progression free survival and overall response rate was no statistically significant     difference between gefitinib and docetaxel. This suggests gefitinib can provide similar     overall survival to docetaxel in pretreated advanced non-small-cell lung cancer patients.     These studies have demonstrated that gefitinib is effective for the second-line treatment of     NSCLC. Now, gefitinib is recommended in advanced and metastatic NSCLC as second-line     chemotherapy.      But, there was no prospective study with gefitinib in NSCLC wih squamous cell histology. This     trial will investigate the efficacy and safety of gefitinib in locally advanced, metastatic     NSCLC patients with squamous cell histology who have failed first-line chemotherapy.   "
137437|NCT01485796|"     The purpose of the study is to acquire additional data on safety and tolerability of     recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune     Globulin Infusion (Human), 10% (IGI, 10%) and to assess the mode of product administration.      Following a discussion with the FDA at the end of July 2012, all participants still active in     the study stopped treatment with rHuPH20 to assure safety of the participants participating     in the study and went into a safety follow-up.      During this safety follow-up period, participants underwent treatment with the licensed     product IGI, 10% (Gammagard Liquid). The intravenous or subcutaneous administration route was     at the discretion of the participant and the investigator.   "
137438|NCT01485783|"     Approximately 200 children age 6 - <18 years receiving medications for essential hypertension     (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine     clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure     monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained     with the ABPM will be compared to measurements obtained by routine clinical procedures     documented in the subject's clinical chart. Kappa statistic will be utilized to compare     differences in documented BP control between the two measures as well as changes in     therapeutic management decisions by treating physicians with the addition of the ABPM     readings. The overall goal is to confirm that ABPM leads to an increased detection of     uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive     medication regimens.   "
137439|NCT01485770|"     This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in     the treatment of excessive daytime sleepiness in adults with narcolepsy.   "
137440|NCT01485757|"     HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and     exercise tolerance will be abnormal in the population of young heart transplant patients at     baseline, and that each will show a trend towards improvement following a 12 week course of     oral L-arginine, with regression towards the baseline following the 12 week washout period.   "
137441|NCT01485744|"     LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade     of molecular events that control cell growth and have been linked with the development of     many human cancers, including pancreatic cancer. Information from research studies suggests     that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In     this research study, the investigators are looking to determine the maximum dose of LDE225 in     combination that can be given safely to patients with locally advanced or metastatic     pancreatic cancer.   "
137442|NCT01485731|"     Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for locally     advanced cervical cancer.   "
137443|NCT01485718|"     Glucomannan is a dietary supplement that has been marketed for weight loss. There is some     research that supports this claim but more research is necessary. This is research study is     being conducted to determine if the dietary supplement glucomannan is effective for weight     loss in adults greater than 18 years of age who are overweight.      Participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either     glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times     daily. The study will last for 12 weeks.      At the start of the study participants will be asked questions about current medications and     diet/exercise regimen, a weight and height will be obtained, and they will be given a     one-month's supply of study supplement. An investigator will call each participant after they     have been taking the supplement for 2 weeks to ensure that the participant is tolerating the     supplement and answer any questions. Throughout the study, participants will be required to     follow-up with investigators in the office every 4 weeks (a total of 3 follow-up     appointments). Every 4 weeks, the investigators will weigh participants, count the leftover     capsules from the previous month, and ask about any adverse effects you may be experiencing.     At the conclusion of the study, a final weight will be compared with the baseline weight to     determine if the medication had an effect on weight loss.   "
137444|NCT01485705|"     The aim of the study is to determine the frequency of sub-optimal care in the initial care     (before arrival at the intensive care unit) of children from West France regions suffering     of severe bacterial infections.The characteristic optimal or not of the initial medical     care will be determined by 2 independent experts, blinded from each other and blinded from     the issue of the care. In case of a discordance between the two experts, a third expert will     be demanded. Three possibilities of conclusion will be proposed to the experts: sure     sub-optimal medical care, possible suboptimal care and optimal care.   "
137445|NCT01485692|"     This study aims to evaluate the efficacy and safety of four options of medications in the     management of acute psychomotor agitation,or violence and aggression situations in health     services. All of the treatment options are already approved and currently used for this     purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine,     olanzapine and ziprasidone. The investigators hypothesized that all treatment options are     effective in the treatment of acute agitation, but the combination haloperidol plus     promethazine could elicit more adverse affects than the others.   "
137448|NCT01485653|"     The use of ultrasonography as an adjunct to regional anesthesia has significantly increased     in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of     ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution     of the block solution. When compared to other methods of nerve localization, sonography     decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use     of ultrasound for peripheral nerve blockade demonstrates decreased procedure related     complications such as nerve injury and unintentional vascular puncture.      Traditional axillary block techniques relying on surface anatomical landmarks require large     volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy     offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield     successful axillary plexus blockade. Therefore, the tradition of using large volumes of local     anesthetic for axillary blocks, even without ultrasound, may not be warranted.      Although recent investigations support using a low volume of local anesthetic for brachial     plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary     objective of this study was to evaluate 2 different volumes of local anesthetic for axillary     blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5%     solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks,     which is secondary to: rapid onset of action, intermediate duration of effect, and relative     low cost. The primary outcome was block success rate for outpatients undergoing distal upper     limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time     required to perform the block, and onset of sensory and motor blockade.   "
137449|NCT01485640|"     This is an open-label continuation study designed to monitor the safety, tolerability and     effectiveness of lurasidone in subjects who have completed participation in a lurasidone     extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment     with lurasidone.   "
137450|NCT01485627|"     The purpose of this study is to determine whether a combined intervention for patients,     caregivers and oncologists improves communication, quality of life, and quality of care.   "
137452|NCT01485601|"     The purpose of this study is to find an optimal dose to determine the safety and tolerability     of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular     injection in subjects with glabellar lines compared with the standard dose of BOTOX®   "
137453|NCT01485588|"     Phase 1: The purpose of this study is to evaluate the safety and tolerability of single     ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration.      Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2     different dose levels.   "
137454|NCT01485575|"     Intravitreal dyes are intended to make the surgical extraction of the Internal limiting     membrane (ILM) safer and more complete. However, the search for an adequate vitaly dye is     ongoing. The most commonly used vital dye is Indocyanine green (ICG), although it is not     approved for intravitreal use and has been associated with ocular toxicity. The reason for     its continued popularity seems to be that it stains the ILM better than the approved and less     toxic alternative substances Brilliant Blue G (BBG) and Trypan blue (TB). According to     anecdotal reports from surgeons, another reason for ICGs popularity may be the fact that it     seems to make ILM removal easier. Ultimately, the intention of the investigators research is     to identify possible modifications to existing dyes to reach improved intraoperative dye     utility combined with a favorable safety profile.      Protocol was amended and approved concerning additional use of basal membrane of deceased     donors.   "
137455|NCT01485562|"     A double-blind individual randomized controlled study of misoprostol vs. placebo for     treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in     Pakistan.   "
137456|NCT01485549|"     The main objectives are to determine on one hand whether oligomeric alpha-synuclein levels     are increased in MSA patients compared to controls and on other hand whether there is a good     agreement between cerebrospinal fluid (CSF) and plasma levels.   "
137457|NCT01485536|"     The goal of this clinical research study is to learn if AUY922 can help to control refractory     or recurrent lymphoma. The safety of AUY922 will also be studied.      AUY922 is designed to block tumor growth by blocking a protein.   "
137458|NCT01485523|"     The diagnosis of allergic rhinitis to dust mites is difficult and based on three elements :     suggestive symptoms of clinical sensitization to dust mites (rhinitis), the existence of an     IgE sensitization defined by skin tests and / or specific IgE positive to mite and finally     the presence of mite allergens in the environment where the patient is symptomatic.     Unfortunately, the link between symptoms and exposure to dust mites is rarely found and     according to in the literature, 30% of rhinitis sensitized to house dust mites did not react     during a conventional nasal provocation test (TPNC) to dust mites. Thus, TPNC to dust mite     has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a     doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or     the variability of the allergic symptoms during the year. However, this test has not been     completely validated with a study including a significant number of patients. That's why the     investigators plan a prospective single-center comparative open study with the main objective     is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC)     in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and     patients with allergic rhinitis not sensitized to dust mites. The investigators secondary     objective is to compare the TPNC a faster TPN-called minute (60 minutes) and which allow a     wider use. If the investigators demonstrate the validity of TPN then it would become the gold     standard needed to decide on a desensitisation to mites.   "
138125|NCT01475786|"     The purpose of this study is to determine if VM202 is safe and effective in treating painful     diabetic neuropathy.   "
137459|NCT01485510|"     Early intervention for maltreated infants can improve mental and physical health throughout     life and benefit families and society as a whole. The New Orleans Model provides intensive     assessment and treatment for families of maltreated preschool children in foster care, with     recommendations to court about adoption, or permanent return to birth families. The New     Orleans Model appears to have led to better informed decisions about permanent placement and     to better child mental health in Louisiana. The investigators propose an exploratory     randomised controlled trial investigating the effectiveness of the New Orleans Model in the     Scottish context, informing the development of an economic model to explore the potential     cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the     New Orleans Model or case management i.e. quality assured services as usual, using random     allocation. The investigators will measure outcome using well validated measures of     parent-child interaction, cognition and attachment.   "
137462|NCT01485471|"     Otitis media is more common in young children and it is estimated that 75% of all children     experience at least one episode before the age of three. Otitis media is one of the common     pediatric diagnoses and recurrent episodes account for the most commonly performed surgical     procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition     which depends on subjective assessment of the ear drum via direct visualization using an     otoscope. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the     analysis of ear drum and the middle ear.   "
137463|NCT01485458|"     Controversy exists regarding the optimal management of acute traumatic cervical spinal cord     injury (SCI), especially those without bone injury. Although surgical decompression is often     performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery     continues to be a subject of intense debate. In this randomized controlled trial, the     investigators compare two strategies: early surgery within 24 hours after admission and     delayed surgery following at least 2 weeks of conservative treatment. The purpose of this     study is to examine whether early surgery would result in greater improvement in motor     function as compared with delayed surgery.   "
137464|NCT01485445|"     The purpose of this study is to determine the bioequivalence of fluticasone furoate (FF)     inhalation powder (single strip configuration) compared with FF inhalation powder (two strip     configuration) and compared with FF / vilanterol (VI) inhalation powder. Fluticasone furoate     (FF), is being developed both as a monotherapy for the treatment of asthma and in combination     with vilanterol (VI) for the treatment of asthma and Chronic Obstructive Pulmonary Disease     (COPD). Thirty healthy male and female subjects will be enrolled in the study to ensure     twenty-four evaluable subjects.   "
137465|NCT01485432|"     This study is designed to compare the incidence of delayed graft function in patients     following renal transplant surgery with different perioperative hemodynamic managements: a     goal directed hemodynamic management group (using PiCCO) and a control group.   "
137466|NCT01485419|"     Traumatic injury is a major public health problem with an immense societal cost. Despite     improvements in trauma management, patients continue to suffer significant morbidity and     mortality. Evidence suggests that males and females tolerate severe injury differently with a     greater protection afforded to females. Determining the mechanisms responsible for these     sex-based outcome differences after injury, focusing specifically on the early sex-hormone     environment post-injury, may allow those at highest risk for poor outcome to be predicted and     promote interventions that can improve outcomes for all injured patients. The goal of this     study is to determine if the early sex hormone environment soon after injury has effects on     the intensity of the immune response, resuscitation and blood transfusion requirements, and     important clinical outcomes including mortality, organ failure and infection, following     significant injury.   "
137467|NCT01485406|"     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the     GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study     entry.   "
137468|NCT01485393|"     The purpose of this study is to determine whether dexmedetomidine can be used to induce     normal physiological sleep in humans.   "
137469|NCT01485380|"     The investigators are doing this research study to find out how and where dexmedetomidine, a     sedative anesthetic, acts in the brain. The investigators will do this by using a machine     that records the brains electrical activity, called an electroencephalogram (EEG), and brain     imaging scans to look at the brain.   "
137470|NCT01485367|"     This is an open label 6 month pilot study for male and female participants over the age of 52     that desire treatment and prevention of senile purpura of the forearms.      This study will be evaluating the effects of Adapalene 0.3% for the use in the treatment and     prevention of senile purpura.   "
137471|NCT01485354|"     The purpose of this study is to assess the clinical outcomes of upper extremity training     using the Armeo Spring system in a chronic post-stroke population with impaired upper     extremity function.   "
137472|NCT01485341|"     The idea is to evaluate if the so called Gluten Sensitivity is a real clinical entity.     Gluten sensitive (GS) persons are defined as those patients, being neither celiac or allergic     to weat, who develop symptoms following gluten consumption. This will be achieved by     evaluating a global symptom score in GS patients receiving gluten compared to those receiving     placebo (primary end point). Symptoms to be evaluated: gastrointestinal (Gastrointestinal     Symptom Rating Scale, GSRS); not-gastrointestinal (specifically built evaluation scale); VQV     scale, built to evaluate quality of life. Gluten or placebo will be administered daily (10 g)     for 15 days; for the 15 days before and 15 after all patients will stay on Gluten Free Diet     (GFD). Besides clinical evaluation (each week for 6 weeks), intestinal permeability testing     and blood sampling will be requested for the identification of possible markers (serological,     gut barrier function, immunological and expression of tight junctions constitutive proteins)     that may be of help to differentiate the condition of gluten sensitivity (GS) from that of     Celiac Disease (CD)(secondary end point). Inclusion and exclusion criteria for patients     enrolling are strictly dependant on the given Gluten sensitivity definition. We expect to     experience a worsening of gastrointestinal and extra-gastrointestinal symptoms, from hours to     days, with an increase in the overall symptom score, above the cut off, in at least 45% of GS     subjects enrolled and that have received gluten compared to GS who received placebo.   "
137473|NCT01485328|"     This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic     digestive complaints.   "
137474|NCT01485315|"     Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive     care unit. The evidence that blood transfusion leads to improved outcome is limited and the     blood may be harmful to some of these patients. To bridge the gap between clinical practice     and evidence, a large randomised clinical trial is needed to document the efficacy and safety     of RBC transfusion in these very sick patients   "
137475|NCT01485302|"     Primary Objective:      - To assess the safety and tolerability of escalating single and multiple doses of SAR228810     in patients with Alzheimer's disease (AD)      Secondary Objective:      - To evaluate the pharmacokinetic properties of SAR228810 after escalating single and     multiple doses of SAR228810 in AD patients   "
137796|NCT01481129|"     This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with     relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
137476|NCT01485289|"     The intent of this study is to complete the collection of clinical data on subjects enrolled     in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the     now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the clinical     trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased their funding     of the trial, a number of enrolled patients had not yet completed the two year follow-up     visit defined as the study endpoint in the clinical investigation plan. No additional patient     treatment is required to complete the study. Rachiotek has interest in pursuing IDE approval     for a new study and the information collected in this study is essential for supporting the     new Investigational Device Exemption application.   "
137477|NCT01485276|"     Background:      - Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is an approved treatment for     Parkinson s disease. It stimulates a part of the brain that helps control symptoms like     tremor, stiffness, and slow movements. However, many people continue to have unsteadiness and     slowness while walking, trouble swallowing, and speech problems even with STN DBS. Another     type of DBS focuses on a part of the brain called the pedunculopontine nucleus (PPN). PPN DBS     has improved walking in some people with Parkinson's disease. Researchers want to see if     combining the two types of DBS may help control symptoms better than STN DBS alone.      Objectives:        -  To see if PPN DBS can help walking, balance, speaking, and swallowing in those who          already have STN DBS.        -  To study how the DBS combination affects brain function.      Eligibility:      - Individuals with Parkinson s disease who had STN DBS surgery at least 1 year ago, but still     have difficulty walking, swallowing, and speaking.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have neurological tests and other tests to measure Parkinson s disease symptoms.        -  This study requires eight visits over 1 year. One of the visits will be a 9- to 10-day          admission to the NIH Clinical Center for DBS surgery.        -  Participants will have PPN DBS surgery. The surgery will be done in two steps. In the          first step, the leads will be placed in the brain. In the second step, 1 week later, the          stimulator device will be placed in the chest or abdomen.        -  One month after the surgery, participants will have a study visit to program the PPN DBS          device to find settings that will improve walking and balance.        -  Participants will have study visits 2, 3, 6, and 12 months after surgery. Each visit          will be used to check the stimulators and make any adjustments needed to try to improve          walking and balance or to lessen side effects. Participants will have tests of walking          and balance, speech, and swallowing. Some tests will be done with different combinations          of the stimulators on or off to see the effects of each set of stimulators.   "
137478|NCT01485263|"     Objective      The objective of this pilot study is to characterize the abnormal neuronal firing patterns of     basal ganglia neurons and those in the premotor cortex in patients with treatment-resistant     movement disorders undergoing deep brain stimulation (DBS) surgery.      Study population      Fifteen adult patients with treatment-resistant movement disorders who are undergoing deep     brain stimulation surgery at Suburban Hospital, Bethesda, Maryland, will be studied.      Design      This is a physiology study of treatment-resistant movement disorder patients who have been     scheduled for implantation of a deep brain stimulation device into the Nucleus accumbens.     Prior to surgery, patients will learn a rewarded visual-motor task and undergo     magnetoencephalography. The task will be repeated during DBS surgery, with collection of     information on electrical activity including single neuronal unit and local field potentials.     The task and MEG will be repeated 3-4 months after surgery. The collected data will be     analyzed for coherence patterns during rest and rewarded movements.      Outcome measures      We plan to characterize and quantify the oscillatory activity present in motor circuits of     treatment-resistant movement disorder patients during rewarded visually guided movements. We     hypothesize that during visually guided movements, neuronal coherence will be significantly     increased relative to resting periods. Thus, by better understanding the alteration in     oscillatory patterns in these patients, we hope to develop better DBS stimulation paradigms     in order to better treat this disease in the future.   "
137479|NCT01485250|"     Background:        -  Individuals often participate in clinical trials to seek new therapies and free medical          treatments for their illnesses or chronic conditions. However, less is known about the          motivations of the healthy individuals who volunteer for research studies.        -  Although many healthy volunteers participate in clinical trials for financial          compensation, the particular risks involved in testing drugs that have not been tried in          human clinical trials pose potential dangers for healthy volunteers in Phase I studies.          More research is needed to understand the motivations of volunteers who participate in          Phase I clinical trials.      Objectives:      - To evaluate the primary and secondary motivations of healthy participants in research     studies.      Eligibility:      - Individuals at least 18 years of age who are healthy volunteers in selected Pfizer Phase I     clinical trials.      Design:        -  Individuals who express interest in participating in specific Pfizer Phase I drug          studies will be asked to complete a short questionnaire after completing the standard          consent session for the study.        -  Those who enroll in the trial will be asked to complete a second questionnaire prior to          discharge from the study.   "
137480|NCT01485237|"     The main purpose of this study is to review the resource utilization of severe adult H1N1     pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with     pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg.     Secondary objectives include, comparison of resource utilization to other similar disorders     (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look     at the percentage of patients that required ICU care as compared to those who could be cared     for on medical wards. The investigators will determine the resources used by both groups and     compare. Finally the investigators will record the frequency of chronic comorbidities in     hospitalized adult H1N1 patients.   "
137519|NCT01484730|"     The purpose of this research is to evaluate and validate the performance of non-invasive     imaging modalities for assessment of skin. A pressure cuff occlusion will be used to     stimulate blood flow dynamic that these instruments are designed to sense. The researcher     currently plan to assess only basic feasibility of the imaging instruments.   "
137481|NCT01485224|"     Hereditary hemorrhagic telangiectasia (HHT) (OMIM 187300 and 600376), also known as     Rendu-Osler-Weber syndrome, is an autosomal dominant disease and has a prevalence between     1:5000 and 1:8000 in different populations. Clinically, the occurrence of mucocutaneous and     gastrointestinal telangiectasias and of systemic arteriovenous malformations is commonly     observed. Recurrent and severe epistaxis, due to the presence of telangiectasias in nasal     mucosa, is the most common presentation of HHT, frequently leading to severe anemia requiring     intravenous iron and blood transfusions. Although not life threatening, severe epistaxis has     a great impact on quality of life in HHT patients and it represents the most important     impediment in daily activities, that poses therapeutic challenge. Recently, angiogenesis has     been implicated in the pathogenesis of HHT. Circulating concentrations of both TGF-beta and     vascular endothelial growth factor (VEGF) are significantly elevated and therefore,     anti-angiogenic substances may be effective in the treatment of vascular malformations in     this disease. Thalidomide functions as a potent immunosuppressive and antiangiogenic agent.     The aim of this study is to assess the clinical effects of thalidomide therapy on the     severity of epistaxis in subjects with HHT who are refractory to standard therapies.   "
137483|NCT01485198|"     Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will     be allocated into two groups:        -  The control group will receive Acetaminophen 750mg orally every 8 hours        -  The experimental group will receive Autologous Hematopoietic Stem Cells from bone marrow          (BMASC)      Signed informed consent is required, as well as answering a questionnaire.      Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3     consecutive days and, on the 4th day a bone marrow harvest under general sedation will be     performed from posterior iliac crests. The patient will remain in the recovery room while the     cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to     the joint under local anesthesia.      The procedure is ambulatory.   "
137484|NCT01485185|"     This study will compare the effects of gabapentin alone, and gabapentin + donepezil given     together in two types of experimental electrical pain tests in up to 48 healthy male subjects     (after 24 recruited in the first cohort an interim analysis will be performed).      The study is a randomized, double blind, placebo controlled, 3 was cross-over design study     with incomplete block design and 4 treatment options. Placebo, gabapentin alone (lower dose     and higher dose) or gabapentin (lower dose) with donepezil.   "
137485|NCT01485172|"     This study is a fixed dose, dose response study to characterize the dose response for     ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and     baseline assessments, subjects will be randomized to one of six final target treatment groups     (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening     period, an up-titration period, a maintenance period, a down titration period and a follow up     period. This study utilizes change from baseline in the UPDRS motor score as the primary     endpoint, in line with that used in the ropinirole PR monotherapy pivotal study     (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in     order to establish the lowest maximally effective therapeutic dose.   "
137486|NCT01485159|"     This is a cross-sectional, observational study, investigating the point prevalence of Airflow     Limitation in current or former smokers with established ischemic heart disease. The study     will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.   "
137487|NCT01485146|"     This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety,     tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy     subjects.   "
137488|NCT01485133|"     Water method with water exchange has been shown to reduce medication requirement and pain     experienced during colonoscopy. It increases the success rate of cecal intubation in sedated     and unsedated patients undergoing screening colonoscopy. Exchange of water during scope     insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion     of air from the colon during insertion by omission of air insufflations and suction removal     of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy     insertion in average patients and may enhance the success of difficult colonoscopy.      Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the     probable adhesion may change the anatomy and increase the discomfort of patients. We     postulate that these patients may benefit from using the water method for colonoscopy. In     this proposal we test the hypothesis that compared with conventional air insufflations the     water method with water exchange significantly enhances the success rate of cecal intubation     in patients with prior abdominal or pelvic surgery.      The aim of the study is to compare the outcome of colonoscopy using the water method versus     the conventional air method in patients with prior abdominal or pelvic surgery. The primary     outcome is cecal intubation success rate. The secondary outcomes include cecal intubation     time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma     detection rate.   "
137489|NCT01485120|"     The purpose of this study is to establish the performance of a blood pressure cuff. The     hypothesis is that the blood pressure reading from the cuff will provide similar blood     pressure as a radial artery.   "
137490|NCT01485107|"     Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using     the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days     post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and     tighten the skin of the décolleté region.   "
137491|NCT01485094|"     The purpose of this trial is to determine whether a novel analgesic is effective in treating     of neuropathic pain caused by herpetic infection, surgery, or trauma.   "
137492|NCT01485081|"     The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel     Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native     coronary arteries.   "
137493|NCT01485068|"     The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting     Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.   "
137543|NCT01484418|"     Chronic low back pain often results in psychosocial and physical disability. A subgroup of     these patients shows fear of (re)injury and avoidance behaviour leading to higher disability.     The purpose of this study is to determine whether exposure in vivo is more effective in the     treatment of fear avoidant chronic back pain patients than psychological treatment as usual     (cognitive behavioural psychotherapy).   "
137494|NCT01485055|"     Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common     development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells     attack and damage your tissues and organs after transplant.      Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have     blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the     skin or eyes), damage to other organs      Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that     develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD).     Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life     threatening condition. There is no standard treatment and it may not respond to treatment.      The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD.      Participants in this study will receive combination therapy (2 drugs: infliximab and     basiliximab) once a week for four weeks.   "
137507|NCT01484886|"     In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a     more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and     possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will     not affect the cardiac or pulmonary status of the patient.   "
137508|NCT01484873|"     The purpose of this study is to determine whether exenatide can cause weight loss in patients     with a history of craniopharyngioma or other brain lesion.   "
137496|NCT01485029|"     Antibiotic consumption and antimicrobial resistance remain notoriously high in France,     particularly among children below three years of age. In France, the pneumococcal conjugate     vaccine was officially recommended for all children under two in 2003, and consequently     changes occurred in Streptococcus pneumoniae serotype distribution. Bacterial carriage among     children attending day-care centres may result from vaccine- and antibiotic-driven selective     pressure with possible repercussions on the community.   "
137497|NCT01485016|"     The purpose of this study is to gather changes in physiological and biomechanical data during     daily activity and sleep in epilepsy subjects.   "
137498|NCT01485003|"     The primary objective of the study is to determine which baseline and yearly response factors     (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24,     and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives     are: To identify prognostic factors at Baseline that predict overall disease-free status at     Month 12, and to assess if yearly overall disease-free response factors predict overall     disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded     Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36, and 48; To     identify prognostic factors at Baseline that predict clinical disease-free status at Month     12, and to assess yearly clinical disease-free response factors that predict clinical     disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate     the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the     following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week     sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,     36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with     Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on     the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity     Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,     36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test [SDMT]),     capacity for work (Work Productivity and Activity Impairment Questionnaire [WPAI]), quality     of life (QoL) (Multiple Sclerosis Impact Scale [MSIS-29])   "
137499|NCT01484990|"     A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced     Parkinson's Disease.   "
137500|NCT01484977|"     The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide     (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with     withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects     not well controlled on their current regimen.   "
137501|NCT01484964|"     The purpose of this study is to determine the bioavailability and pharmacokinetics between     two different formulations of ASP015K tablets and determine the food effect on the absorption     of the new formulation.   "
137502|NCT01484951|"     The purpose of this study was to assess the safety and efficacy of switching to Azarga from     prior pharmacotherapy in patients with open-angle glaucoma.   "
137503|NCT01484938|"     The purpose of this study was to describe mean differences in corneal staining (type and     area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared     to Baseline (Day 0).   "
137504|NCT01484925|"     This research study hopes to identify new molecular markers in the tissue of Barrett's     esophagus that will help physicians better understand and manage this condition. Patients     undergoing an upper endoscopy will be asked to complete a gastroesophageal reflux disease     (GERD) questionnaire, provide a blood sample and allow additional biopsies to be taken during     the procedure.   "
137505|NCT01484912|"     The objectives of this study are to evaluate the efficacy, pharmacological activities and     safety of STA-2 in the treatment of chronic stable angina.   "
137506|NCT01484899|"     Environmental factors may play a role in the genesis of pulmonary hypertension, especially in     endothelial dysfunction. One widespread environmental factor associated with systemic     endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not only     a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact     with other risk factors such as a genetic background and associated conditions. The existing     studies which deal with this subject are only small single center case control studies     providing less data. Therefore a large European multicenter study is necessary.      The investigators hypothesis are:        -  a history of tobacco smoke exposure is highly prevalent in patients with PAH compared to          the unaffected general population.        -  a history of tobacco smoke exposure is more prevalent in patients with PAH compared to          CTEPH.   "
137923|NCT01479465|"     This randomized study compares the efficacy of simtuzumab (GS-6624) versus placebo in     combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in     participants with metastatic KRAS mutant colorectal cancer.   "
137509|NCT01484860|"     This is a phase II study to see how useful study drug AUY922 is in patients with metastatic     pancreatic cancer who have received or are intolerant to first-line chemotherapy.      AUY922 is an intravenous drug that blocks a protein called heat shock protein 90 (Hsp90).     Hsp90 works by keeping a number of other proteins stable and active, including many proteins     that are involved in tumor growth and death. When Hsp90 is blocked from working, it is     believed that many of the other proteins that it stabilizes will also be blocked, which will     cause tumor growth to slow or stop.      During the study, patients will visit the clinic once a week, every 4 week cycles to receive     AUY922 intravenously and to have tests and procedures done. As part of the study, archived     tumor tissue will be collected and patients will be asked to have blood samples taken for     pharmacokinetic testing. Patients will be invited to take part in an optional banking of     blood samples for future studies.      The primary hypothesis of this study is that AUY922 improves disease control rate compared     with what would be expected from best supportive care.   "
137510|NCT01484847|"     This is a study to assess how much of the investigational drug, PF-00298804, is in the blood     stream over a period of time (called pharmacokinetic tests or PK) in patients with locally     advanced head and neck squamous cell carcinoma who have a (gastrojejunostomy) feeding tube.   "
137511|NCT01484834|"     The goal of this research was to investigate different intervention strategies in the     workplace and their impact on quality of life of workers from companies in the city of     Londrina, Parana, Brazil.      The interventions were composed by exercise in the workplace and educational interventions.   "
137512|NCT01484821|"     Sarcopenia is known to be associated with loss in muscle mass that results from a reduced     number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration     of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia     impairs muscle function resulting in a higher risk of physical disability and death. The     commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray     absorptiometry) scan. However, this test can't provide structural muscle information. In     contrast, the mechanical properties of muscle tissue can be explored using an acoustic     radiation force impulse (ARFI). The question remains whether muscle sonoelastography using     ARFI imaging could be helpful for sarcopenia screening.      For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both     without any serious chronic disease, and patients ≥ 70 years presenting curative cares for     cancer (Gr C).      The volunteers belonging to the groups A and B will be followed during one day. The patients     included in the group C will be followed during 6 months. For this latter group; the first     visit (t0) will take place before treatment and the second visit will take place 6 months     later (t6months) Volunteers will have clinical examinations (weight, stature, BMI,     performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h     dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk     test, QLQ-C30 items relative to the fatigue symptom).   "
137513|NCT01484808|"     This is a review of previously published data from a large prostate cancer prevention study     known as REDUCE. It is the investigators intention to review whether prostate specific     antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and     its grade and stage (severity).   "
137514|NCT01484795|"     Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major     cause of mortality and morbidity in the world. The myocardial ischemia is often the     precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive     pressure has been used as a therapeutic modality.      Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory     and hemodynamic variables in patients with myocardial infarction.      Materials and methods: ten patients with acute myocardial infarction, with Killip I     classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation     during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will     be registered and electrocardiogram signals will be recorded for posterior analyses of HRV.     Data will be collected before, during and after positive pressure ventilation.      Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed     by Tukey test.   "
137515|NCT01484782|"     The purpose of this study is to evaluate the feasibility of utilizing an interactive voice     response (IVR) system to supplement hypertension self-management for patients in     underdeveloped regions in Mexico and Honduras. Weekly disease assessment calls included     hypertension self-management suggestions and support to patients. The impact on patients'     blood pressure levels and other secondary outcomes were evaluated.   "
137516|NCT01484769|"     Collection of tissues for analysis from patients undergoing elective neck dissection.      The hypothesis of the study is that specific genetic alterations occur in head and neck     cancers that have spread to regional and/or distant sites, and these alterations can be     identified from biopsy specimens to allow more accurate staging of tumor and better treatment     planning.   "
137517|NCT01484756|"     Nutrient deficiency and immune dysfunction in older persons result in high prevalence of     acute respiratory infection,which can lead to impaired nutritional status. The study     objective was to determine the effect of multi micro-nutrient supplementation on nutritional     and upper respiratory infection among apparently healthy community-dwelling elderly. The main     hypothesis was whether daily multi micro-nutrient supplementation could reduce the incidence     and prevalence of upper respiratory infection among apparently healthy community-dwelling     older persons. Inclusion criteria were apparently independent healthy male and female older     persons aged 60 years and over, not taking multi micro-nutrient supplementation over the last     month. The study design was a community-based double-blind controlled trial involving 296     community-dwelling older persons aged 60 and above, in the Mampang Prapatan district, South     Jakarta. Participants were randomized to receive either 40 mg elemental zinc (as gluconate),     120 mg ascorbic acid, 6 mg B-carotene, 15 mg alpha tocopherol (as d-alpha-tocopheryl acid     succinate) and 400 micrograms folic acid (intervention group) or 400 mg calcium carbonate     (control group). Supplements were taken daily for six months, from August 2008 to March 2009.     Nutritional and health status were measured before and after supplementation. Poisson     regression analysis was used to evaluate the effects of daily multi micro-nutrient     supplementation on the incidence and prevalence of upper respiratory infection.   "
137924|NCT01479452|"     The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of     bariatric surgery on overall mortality and obesity-related co-morbidities.   "
137520|NCT01484717|"     Cigarette smoking remains the most common source of preventable morbidity and mortality in     the United States, with in excess of $167 billion in economic costs per year. Contingency     management (CM), in which tangible incentives are provided contingent on a target behavior     like abstinence, is highly efficacious in improving substance abuse treatment outcomes and is     receiving increased attention for smoking cessation. Expired carbon monoxide (CO) is the most     common objective smoking status test used in smoking research and treatment. Unfortunately,     multiple CO tests/day are typically required to detect all smoking and reinforce sustained     abstinence. The resulting logistical and resource limitations greatly limit the application     of this potentially powerful quit smoking toolset. This study addresses these limitations by     examining the effectiveness of using interactive voice response technology (IVR) to implement     CM. Smokers who want to quit (N = 90 randomized) will receive 2 quit preparation sessions     based on public health guidelines for smoking cessation and set a target quit date.     Participants will be randomly assigned to 1 of 2 treatment conditions: (a) IVR-S consisting     of objective smoking status monitoring using IVR, telephone counseling and transdermal     nicotine and (b) IVR-CM, consisting of the same monitoring, telephone counseling and     transdermal nicotine plus IVR-based CM for smoking abstinence. It is hypothesized that     abstinence rates will be higher in the IVR-CM condition compared to the IVR-S, supporting a     combined IVR CM approach, and thereby greatly increasing the applicability of these powerful     smoking cessation tools.   "
137521|NCT01484704|"     The purpose of this study is to determine how MRI changes the treatment and diagnostics of     ductal breast cancer. 100 women with newly diagnosed breast cancer will participate the     study.   "
137522|NCT01484691|"     This will be a single center study of asthmatic subjects and healthy controls which will     investigate mechanisms of asthma through detailed molecular analysis of airway tissues and     fluids. The primary goal will be investigate the role of microRNAs in Th2-driven inflammation     in asthma. The investigators hypothesize that asthma is associated with abnormal expression     of miRNAs in T cells which favors differentiation into Th2-cells. The investigators further     hypothesize that asthma is heterogeneous based on the presence and absence of Th2-driven     inflammation and that abnormalities in T cell miRNA expression will be most prominent in a     subgroup with high levels of Th2-driven inflammation (as assessed using molecular markers     that the investigators have previously established). Finally, the investigators hypothesize     that inhaled corticosteroids will normalize the T-cell miRNA abnormalities observed in     asthma, as corticosteroids treat Th2-driven inflammation. The samples collected will also     facilitate the pursuit of secondary analyses designed to investigate mechanisms of     inflammation and remodeling in asthma as well as molecular phenotypes of asthma.   "
137523|NCT01484678|"     The purpose of this research study is to determine the potential of magnetic resonance     imaging to monitor disease progression and to serve as an objective outcome measure for     clinical trials in Duchenne Muscular Dystrophy (DMD). The investigators also hope to learn     more about the changes that occur in muscles of the lower leg and arm in boys with DMD.      The investigators will compare the muscles of ambulatory or non-ambulatory boys with DMD with     muscles of healthy children of the same age and monitor disease progression in boys with DMD     over a 5-10 year period. The amount of muscle damage and fat that the investigators measure     will also be related to performance in daily activities, such as walking and the loss of     muscle strength. In a small group of subjects the investigators will also assess the effect     of corticosteroid drugs on the muscle measurements.   "
137524|NCT01484665|"     Decision-aids are tools to educate patients on a given topic so that they may better     participate in shared-decision making in their health care. Given the complexities associated     with PSA testing, many professional organizations have advocated for shared-decision making     for PSA testing. However, no consensus exists as to how best educate and involve patients in     the shared-decision making process. The goal of this study is to evaluate a pilot program     utilizing a simple PSA screening decision-aid presented in two different fashions in a     primary care clinic with a large fraction of African-American patients. The investigators     will evaluate the effectiveness of this program to educate patients on the risks and benefits     of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their     decision about whether to receive PSA testing, and on the comfort level of physicians on     their patient's decisions regarding PSA testing, and importantly, how well these strategies     can be implemented into the daily work-flow of a clinic. If successful, this program may     serve as a model for the broader implementation of such strategies across Minnesota and the     country.   "
137525|NCT01484652|"     The primary objective of this study is to show the effectiveness of repeated doses of COV795     versus placebo, using the summed pain intensity difference over the first 48 hours in     subjects with acute moderate to severe pain following bunionectomy.   "
137539|NCT01484470|"     While cord blood transplants have been performed safely in elderly patients, many still     relapse. The investigators propose to intensify the preparative regimen for this patient     group in an attempt to decrease relapses, and combine this with an ex vivo expanded Umbilical     Cord Blood (UCB) unit.   "
137540|NCT01484457|"     Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric     model predictive control can be developed and evaluated safely in patients with Type 1     Diabetes Mellitus (T1DM) to control blood glucose concentrations.      This study seeks to combine real-time continuous glucose sensing with automated insulin     delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end     result of this line of research will be an artificial pancreas that will provide     around-the-clock glucose regulation through controlled insulin delivery in response to     detected patterns of change in glucose levels.   "
137541|NCT01484444|"     BIOMARKER ANALYSES        1. FNA Sample:           From each enrolled patient who meets the inclusion criteria, FNA sample will only be          taken .           FNA will be carried out only in patients with feasible biopsy or FNA site. Ascites or          pleural fluid will be collected for analysis        2. Blood Samples From each enrolled patient who meets the inclusion criteria, blood samples          will be collected. 3 mL blood sample will be collected .        3. tumor tissue Archived Tumor Tissue (Slides) Samples Primary tumor and/or a metastatic          lesion collected. Approximately 5 unstained slides (if available) are collected.   "
137542|NCT01484431|"     The purpose of this study to see how much study drug is in the blood after dosing children     with pulmonary arterial hypertension (PAH) and to establish the correct dose for further     clinical research.   "
137526|NCT01484639|"     This is a multi-centre randomized controlled pilot trial of two transfusion strategies in     high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers     and 1 American centre. Patients allocated to a restrictive transfusion strategy will     receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and     postoperatively. Patients allocated to a liberal transfusion strategy will receive red cell     transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and     postoperatively in the intensive care unit, and less than 85 g/L on the ward.      The primary objectives of this study are to determine 1) enrollment rates (patients     enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3)     protocol adherence (incidence and reasons for non adherence, lack of consent, rates of     contamination and utilization of co-interventions). The secondary objectives are to determine     1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac,     neurological and infectious adverse events; 2) the proportion of missing data as a measure of     the feasibility of the case report form; and 3) the proportion of blood products utilized     (red cells, platelets and plasma).      The results of the multicentre pilot study will be used to 1) maximize enrollment rates to     ensure timely completion of recruitment of a definitive large randomized controlled trial, 2)     maximize adherence rates, 3) determine event rates for sample size estimation for a     definitive study, and to 4) optimize the case report form.   "
137527|NCT01484626|"     The purpose of the study is to determine the safety and efficacy of the use of Bendamustine     in combination with a commonly used combination chemotherapy to treat relapsed and refractory     multiple myeloma. The study will be conducted in two phases. Participants in phase I will     receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of     bendamustine is determined phase II of this trial will begin. Participants in phase II will     receive the maximum tolerated dose of bendamustine in combination with standard of care     chemotherapy.   "
137528|NCT01484613|"     Cardiac resynchronization (CRT) therapy is well established for treatment of patients with     severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony.     Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is     interruption of biventricular pacing. This might be caused by several conditions, including     elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation     (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's     the aim of this prospective observational study to investigate efficacy and reliability of     cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.      Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead,     at least one acceptable LV lead vector is available.   "
137529|NCT01484600|"     This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668     Administered Subcutaneously to Healthy Volunteers.   "
137530|NCT01484587|"     The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a     single subcutaneous (SC, under the skin) dose administered to Japanese participants with     moderate to severe plaque psoriasis.   "
137531|NCT01484574|"     This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy     of different doses of Stempeucel in critical limb ischemia patients.   "
137532|NCT01484561|"     The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of     kidney function in patients with active rheumatoid arthritis (RA).   "
137533|NCT01484548|"     The purpose of this study is to determine the safety, tolerability, and immunogenicity in     healthy adult subjects of an investigational vaccine being developed for the prophylaxis of     visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the     recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant     GLA-SE.   "
137534|NCT01484535|"     This trial will study the effect of hematoma aspiration in patients with acute ankle     fractures.   "
137535|NCT01484522|"     The purpose of this research study is to evaluate the immune response to the H1N1 influenza     or flu vaccine. The immune response is how your body recognizes and defends itself     against bacteria, viruses, and substances that may be harmful to the body.      HIV-1 infected children typically respond more poorly to vaccines compared to uninfected,     healthy children and so this study hopes to learn whether or not the body will successfully     produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1     flu virus. There is no information yet on the safety or immune response to this vaccine in     children infected with HIV.   "
137536|NCT01484509|"     Leg artery disease is a common condition in which fatty deposits develop in the blood vessels     that supply the legs. Many patients with leg artery disease experience a cramp-like leg pain     during walking that is relieved by rest; this is called intermittent claudication. To help     determine the severity of leg artery disease, patients may be questioned about how far they     can walk before claudication pain forces them to stop. However, this information is usually     of limited use because most patients poorly estimate their walking capacity. The     investigators have developed a simple questionnaire to help estimate walking capacity in     patients with leg artery disease. The purpose of this study is to test the validity and     reliability of this questionnaire. By validity, the investigators mean the extent to which     the questionnaire measures what it is supposed to measure (walking capacity). By reliability,     the investigators mean the extent to which the questionnaire produces the same results over     time when completed on two different days.      The investigators hypothesise that the investigators simple questionnaire will be valid and     reliable.   "
137537|NCT01484496|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab     administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).   "
137538|NCT01484483|"     This observational study, conducted by the Kenya Society for Hematology and Oncology, will     develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical     and pathological characteristics, treatment and clinical outcome will be collected from newly     diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry     cohort and followed up for a period of not less than five years.   "
137611|NCT01483534|"     The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or     TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM     will also be evaluated through confirmation of successful application of TLD Therapy.   "
137544|NCT01484405|"     There are two surgical approaches (incision types) used by surgeons who do total hip     replacements. The purpose of this study is to determine which type of surgical approach     (incision type) produces the best results for patients who have a total hip replacement.      Null Hypothesis : There is no difference in complication rate, functional outcome, surgical     time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or     ORIF for femoral neck fractures.   "
137545|NCT01484392|"     The purpose of this study is to determine which medical, demographic, and health belief     factors are associated with glaucoma therapy compliance.   "
137546|NCT01484379|"     Following a personal observation and a retrospective analysis of the data, the investigators     hypothesise that there is increased frequency of multiple gland disease in primary     hyperparathyroidism in the elderly.      This study will include patients over the age of 65, diagnosed with primary     hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to     preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected     followed by an exploration of the other gland at the same time. Data will be analysed to     determine the frequency of multigland disease in this population.   "
137547|NCT01484366|"     The hypothesis is that intramedullary nailing of the ulna and plating of the radius will     result in a superior outcome as evidenced by two primary end points:        1. a lower rate of implant pain        2. a lower re-operation rate to remove painful hardware.   "
137548|NCT01484353|"     The purpose of this study is to determine if a healthy lifestyle intervention can     significantly improve blood sugar control in type 2 diabetics over a course of 3 months.   "
137549|NCT01484340|"     The purpose of this study is to conduct a randomized controlled trial (RCT) of intensive     anti-smoking counseling plus nicotine replacement therapy versus intensive anti-smoking     counseling alone among HIV-infected patients in South Africa, and to concurrently measure the     prevalence of smoking among HIV-infected patients in South Africa.   "
137550|NCT01484327|"     Beta-blockers should be administered to all patients with heart failure stages II to IV NYHA.     It should also be administered to patients with stage I after myocardial infarction. The low     ejection fraction, especially after myocardial infarction is a strong indication for     beta-blockers, as many studies indicate that administration of these drugs substantially     reduces cardiovascular mortality. Beta-blockers reduce mortality and hospitalizations and     improve the operational phase for all categories of patients with heart failure. Since     beta-blockers, only carvedilol, metoprolol, and recently visoprololi nevimpololi have shown     these benefits and thus, only those have to be administered.      The clinical study Carvedia aims to observe and record the action of beta-blocker carvedilol     on cardiac function in patients with heart failure or reduced left ventricular ejection     fraction after acute myocardial infarction.   "
137551|NCT01484314|"     Eltrombopag is a compound that may help stimulate the production of platelets. This drug has     been used in treatment of low platelet counts caused by a disorder called idiopathic     thrombocytopenic purpura and information from those other research studies suggests that     Eltrombopag may help to maintain platelet counts in patients with relapsed multiple myeloma     in this research study.      In this research study,the investigators are trying to determine if Eltrombopag is effective     in maintaining platelet counts in patients who are being treated for relapsed multiple     myeloma.   "
137552|NCT01484301|"     The purpose of this study was to assess the impact of opioid tolerability-related issues     experienced by Canadian chronic pain patients. Approximately 170 patients were enrolled from     16 recruiting centers across Canada. Eligible patients had a diagnosis of non-malignant,     chronic pain requiring continuous use of strong opioids (>=4 days per week). Recruitment was     initiated by physicians during routine care appointments at family or pain medicine     practices. Patients were then directed to a website where they provided consent and completed     an anonymized, password-protected, web-based survey that could be completed at home. This     weekly online questionnaire was designed to document their chronic pain experience over a     12-week period. At the end of the 12-week study, physicians were asked to retrospectively     complete information about pain treatments, over-the-counter (OTC) medication use for pain     and opioid-related gastrointestinal (GI) side effects, as well as co-morbid conditions for     each patient.   "
137553|NCT01484288|"     The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx     Barostim Neo System in the treatment of patients with heart failure.   "
137554|NCT01484275|"     The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with     placebo (an inactive substance that is compared with a drug to test whether the drug has a     real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma     (SMM).   "
137555|NCT01484262|"     This study is conducted in Europe. The intention of this health service research study is to     obtain data from daily routine to evaluate the quality of life and the costs of the disease     for patients with type 2 diabetes mellitus.   "
137612|NCT01483521|"     This is a proposed home visitation program for families of children with externalizing     behaviors who are on the wait list for psychiatric assessment at BC Children's hospital. The     aim of this program is to implement and evaluate a home visitation strategy in order to     support those waiting up to four months to consult a psychiatrist.   "
137556|NCT01484249|"     This study was designed as a First In Man (FIM) trial to evaluate the feasibility and     technical capability of the Claret CE Pro System in delivering two embolic filters to the     brachiocephalic artery and the left common carotid artery during a Transcatheter aortic valve     implantation (TAVI) procedure in order to protect the neurovasculature from debris liberated     during the procedure.   "
137557|NCT01484236|"     RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine     the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic     information and information concerning the timing and modalities of diagnosis.      Based on the registry, we will set up a prospective cohort of patients. The database will     include detailed medical information, particularly regarding progression of the respiratory     function.   "
137558|NCT01484223|"     The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal     intervention (BCI) in patients with somatization symptoms which has an effect on the     perceived quality of life front conventional intervention.   "
137559|NCT01484210|"     The aim of this study is to establish the therapeutic equivalence between the test     (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference     formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the     Fluticasone/Salmeterol combination.      The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover     fashion.   "
137560|NCT01484197|"     This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two     different formulations of indacaterol maleate, both administered via the Concept1 device. The     study aims to determine whether the novel formulation has a similar clinical profile as the     established formulation.   "
137561|NCT01484184|"     As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy     candidate called SPINALON has been identified and is currently under development for its     capacity to temporarily induce episodes of involuntary locomotor movements. The primary     objective of this Phase I/IIa study is to assess safety and tolerability of a single     escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured     patients. As a secondary objective, preliminary evidence of efficacy will also be sought.   "
137562|NCT01484171|"     To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination     with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched     donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid     leukemia (AML).   "
137563|NCT01484158|"     There are growing evidences that gait speed is inversely associated with all causes mortality     especially cardiovascular mortality among the elderly. The purpose of this study is to     evaluate the predictive value of gait speed for cardiovascular events in patients after     ST-segment elevation myocardial infarction (STEMI).   "
137564|NCT01484145|"     The purpose of this study is to determine how much terbinafine is delivered to the nail bed     after treatment with a number of modifications to a previously studied method for     iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small     electric charge to deliver drug across skin and nails.   "
137565|NCT01484132|"     The Composites and Urinary Bisphenol-A Study (CUBS) is a clinical study of dental composite     for its effects on urinary bisphenol-A levels. The study will enroll approximately 139     children recruited from study-affiliated clinical sites in New England.The primary aim of     CUBS is to test the hypothesis that urinary bisphenol-A (BPA) concentrations increase after     composite restoration placement. BPA is a chemical used in the synthesis of matrix monomers     and has been shown to have harmful effects in toxicological studies in laboratory animals.     Currently it is unknown whether dental composite restorative materials containing monomers     that are derived from BPA result in chronic low-dose BPA exposure in children.   "
137566|NCT01484119|"     This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly     patients with seasonal allergic rhinitis, due to mountain cedar pollen.   "
137567|NCT01484106|"     The primary objective of this study is to test whether a fluid resuscitation protocol guided     by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by     an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in     sepsis patients presenting to the Emergency Department without evidence of shock.   "
137568|NCT01484093|"     Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000     cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being     done to better understand how to treat MCL.   "
137569|NCT01484080|"     The investigators plan to study the efficacy of the combination of weekly paclitaxel + BIBF     1120 in early breast cancer using a neoadjuvant schedule and a randomized phase-II trial     design, comparing the efficacy vs. weekly paclitaxel alone, followed by surgery and     subsequent standards of care (anthracycline based chemotherapy, radiation or hormonal     blockade).   "
137570|NCT01484067|"     If a person qualifies to participate in this study, they will have an equal chance of being     assigned to either of two groups. One group will receive a patch that they will need to carry     with them, because as soon as a cold sore starts (within 1 hour) they will need to put the     patch over the sore. The other group will not get a patch, but will need to follow the other     instructions anyway.      When a subject's outbreak begins, they will need to return to the study center within 24     hours. Then they will return according to the appointments given within 10 days. If the study     staff sees that their sore has healed enough before 10 days, subjects will be told that they     don't need to return again.      As long as subjects are in the study, they will need to answer a few simple questions every     day on a card or booklet called a diary, starting the first day of their outbreak. If a     subject is assigned to the patch group, they must wear the patch all the time, taking it off     only to replace it (if it gets loose, dirty, or unsightly) and at the study center, when they     are asked to remove the patch so the sore can be checked.      During the study subjects will be allowed to use paracetamol for pain, but no other     treatments or medicine. If they use paracetamol, subjects must record it in their diary. The     study will be stopped, and there will be no subject visits or treatments during the end of     year holiday break. If a subject experiences an outbreak during the holiday, they may follow     their usual treatment routine.   "
137571|NCT01484054|"     To evaluate and compare the performance of a new contact lens to a marketed contact lens.   "
137572|NCT01484041|"     This study is for women with confirmed hormone receptor positive HER-2 negative advanced     breast cancer with evidence of disease resistance to an aromatase inhibitor.      The purpose of this study is to determine how well these medications work together and/or if     they have any side effects in patients with hormone-receptor positive metastatic breast     cancer who have demonstrated progression of disease after first line hormonal therapy.      This research is being done to determine if taking an already approved medicine (aromatase     inhibitor) in combination with a new medication (dovitinib) results in better outcomes for     patients with this disease.      Both dovitinib and an aromatase inhibitor are pills that will be taken at home.   "
137573|NCT01484028|"     This study will serve to evaluate and compare the performance of two new lenses to a marketed     lens.   "
138156|NCT01476631|"     Hypothesis 1: Exercise will decrease serum markers in a dose response manner.      Hypothesis 2: Participants in the 60 minute intervention will have significantly higher     physical activity levels than those in the 30 minute intervention at three months.   "
137574|NCT01484015|"     This randomized pilot clinical trial studies how well giving prolonged infusion compared to     standard infusion of cefepime hydrochloride works in treating patients with febrile     neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective     than giving cefepime hydrochloride over the standard time.   "
137575|NCT01484002|"     This retrospective study will investigate the changes that occur in ultrahigh molecular     weight polyethylene (UHMWPE) implants that have been retrieved from joint replacement     patients. Analysis techniques will include Fourier Transform Infrared Spectroscopy (FTIR),     Differential Scanning Calorimeter (DSC) and crosslink density measurements. Crosslink density     measurements will be evaluated as a function of distance away from the articular surface and     the rim of the implant. Gel and hydroperoxide contents will also be evaluated. The objective     is to characterize the in vivo and ex vivo changes that occur with cross-linked and     conventional polyethylene bearings sterilized by methods that do not involve radiation. The     investigators hypothesize that polyethylene absorbs lipids in vivo but experiences negligible     oxidation or reductions in polymer crosslinking until it is explanted and stored at room     temperature with access to ambient air.   "
137576|NCT01483989|"     The purpose of this study is to measure corneal epithelial changes in dry eye subjects using     a novel lubricant eye gel.   "
137577|NCT01483976|"     The objective of this study is to verify changes in protein metabolism after ingesting a oral     medical nutritional supplement.   "
137578|NCT01483963|"     The objectives of this study are to assess the safety, effectiveness, and immunogenicity of     AA4500 in the treatment of adhesive capsulitis.   "
137579|NCT01483950|"     This study is non-interventional study of patients who are treated with any HMGCoA reductase     inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and     Herzegovina for at least 6 months. Data collection for each patient will take place at a     single visit. The investigators will complete Case Report Form (CRF) with patient's     demographic, the presence of the factors for high cardiovascular risk, current treatment,     cholesterol value as well as with further treatment decision.   "
137580|NCT01483937|"     Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment     Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance     physical therapy for rehabilitation of patients who fall as a result of vestibular inducted     disequilibrium.      Study participants will receive regular physical therapy, and some will use the SEMD device     while receiving usual care vestibular-balance physical therapy. The device is an elastic belt     that holds eight small battery powered vibrating disks. When using the device, you will sit     or stand on a force platform that measures body sway. That movement information is sent to a     computer which then sends the information to you via the vibrating disks. The vibrating disks     are similar to a vibrating cell phone: you can feel the vibration but it is not     uncomfortable. You can also see your sway movement on the computer screen. Some tests and     activities will be paced with a beeping sound.      The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and     conventional vestibular-balance physical therapy as reported by treating physical therapists'     by counting number of skills acquired in a treatment session, and the amount of time needed     to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores     when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3.     Determine the difference in vestibular habituation between physical therapy plus SEMD and     conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction     in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical     therapy; 5. Determine the patient's perception of quality of life between physical therapy     plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in     acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder     rifle-return to stand between subjects that have trained with SEMD and conventional     vestibular-balance physical therapy .      In addition to primary and secondary outcome measurements, efficiency of skill acquisition,     devised for this study, will be evaluated by tracking the number of skills and length of time     needed to acquire each skill for each physical therapy session using the Patient Skill     Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder     Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated     with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor).     These measurements were devised for this study, and will be evaluated for informational     purposes only.   "
137581|NCT01483924|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,     pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with     moderate to severe chronic plaque psoriasis.   "
137582|NCT01483911|"     ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The     purpose of this first-in-man study is to determine the safety, tolerability and     pharmacokinetics (PK) of ALX-0171 after single and multiple pulmonary administrations in     healthy male volunteers.   "
137583|NCT01483898|"     This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a     patient-specific expanded multicellular therapy, for the treatment of patients with critical     limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI     patients who have no option for revascularization procedures. All patients randomized will     undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office     procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control     into their pre-identified index leg. Patients will be followed for 18 months.   "
137584|NCT01483885|"     Physiotherapy offers a range of therapeutic modalities for pain management including     Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and     Acupuncture. The objective of this study was to investigate the hypoalgesic effect of TENS,     CI and Acupuncture in a cold-induced pain model.   "
137613|NCT01483508|"     The purpose of this study is to determine whether or not the intake of dietary procyanidins     (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.   "
137614|NCT01483495|"     The brain is such a metabolically active organ that it consumes about 20% of oxygen burned     every minute by an average adult even though it only contributes about 2% of the body weight.     As a result, the brain produces a disproportionately high amount of CO2 every minute in     comparison with the rest of the body.   "
137864|NCT01480232|"     This study is designed to evaluate the initial evidence for efficacy of the investigational     medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper     of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers   "
137615|NCT01483482|"     Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures     seen in orthopedics.      There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle     fractures. Conservative treatment has, traditionally, been the preferred treatment but recent     studies have shown higher incidences of non-union and symptomatic malunion associated with     conservative treatment. Primary surgery has in several studies been associated with high     success rates and few complications but there is no compelling evidence towards superior     results after primary surgery.      The objective of this randomized study is to compare conservative treatment (sling) with     primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.   "
137585|NCT01483872|"     Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the     use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in     addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated     bacteremia via a catheter-salvage strategy.      The investigators plan to randomize 102 patients with hemodialysis catheter-associated     bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for     treatment of their infection. Additionally, patients randomized to the interventional arm     will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and     heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only     an anticoagulant solution as a catheter lock which is standard of care - this can be either     heparin or citrate (depending on what agent is standard of care for a particular patient).     The main outcome of interest is successful treatment which is defined as a resolution of the     current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of     follow-up.   "
137586|NCT01483859|"     Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly     introduced noninvasive tool that generates an elastic wave using a vibrator applied to the     thoracic wall at the level of the right lobe of the liver and measures the prolongation     velocity of the wave, which is directly associated with liver stiffness (LS). Although recent     advances in surgical techniques and perioperative management have made with established     perioperative management have now made it possible to perform hepatectomies as a safe     procedure with minimum mortality, the possibility of massive blood loss and resultant     transfusion during hepatectomy still exist. The objective of this research was to identify     the role of liver stiffness measurement for the prediction of intraoperative blood loss and     postoperative recovery after elective right hepatectomy.   "
137587|NCT01483846|"     This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female     subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on     capsaicin-induced hyperalgesia will be assessed.   "
137588|NCT01483833|"     To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied     twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.   "
137589|NCT01483820|"     The purpose of this research study is to evaluate a new investigational drug (TPI 287) for     neuroblastoma and medulloblastoma. An investigational drug is one that has not yet been     approved by the Food and Drug Administration. This investigational drug is called TPI 287.     This study will look at the tumor's response to the study drug, TPI 287, as well as the     safety and tolerability of the drug.      TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in     three different animal species. TPI 287 has been tested in humans in four clinical trials,     and approximately 100 subjects with various types of cancers have received the drug,     including a pediatric population in our previous Phase I trial.   "
137590|NCT01483807|"     This study is designed to examine the effects of speech therapy on ability to produce speech     sounds in persons with acquired apraxia of speech.   "
137591|NCT01483794|"     This is an observational study looking at the characteristics of patients consulting for     genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso,     Chile. The objectives are: to have an epidemiological profile, estimating cost of the disease     for the health system and the patient and analyzing possible psychosocial consequences of the     condition for the patients.   "
137592|NCT01483781|"     The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and     renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin     and being treated for high blood pressure.   "
137593|NCT01483768|"     Subject: Evaluation of the impact of obesity surgery by sleeve gastrectomy on intestinal iron     absorption of morbid obese subjects.      Control of intestinal absorption of iron is mediated by hepcidin, which is expressed in     adipose tissue and that its expression is increased in morbidly obese subjects. The working     hypothesis is that this increase could explain the high prevalence of systemic iron depletion     observed in obese patients.      Main objective: Assess the impact of the decrease in fat mass induced by surgery in obese     patients on the intestinal absorption of iron (evaluated by measuring the expression of iron     transporters in the duodenum)   "
137594|NCT01483755|"     The investigators previously reported that angioplasty postconditioning reduces infarct size     (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital     admission. Animal studies have suggested that the time window for applying brief episodes of     ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow,     i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window     might be larger in humans, i.e. whether STEMI patients might be protected several minutes     after undergoing spontaneous reperfusion before admission coronary angiography.      Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1     were eligible for that study. Angioplasty postconditioning was completed as already published     and infarct size was assessed by measuring cardiac enzymes release.   "
137595|NCT01483742|"     This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and     antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon     alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the     combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or     4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily     (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin     1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid     additionally. Anticipated time on study treatment is 24 weeks.   "
137596|NCT01483729|"     This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate     the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1,     subjects will be randomized to receive single oral doses of one of three tablet formulations     of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout     between periods. In Part 2, subjects will be randomized to receive single oral doses of one     of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with     at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.   "
137597|NCT01483716|"     Obesity is an escalating problem in the UK and a proportion of these patients have a     condition known as Obesity Hypoventilation Syndrome (OHS). This syndrome is associated with     symptoms of breathlessness, reduction in exercise capacity, fatigue and headaches. Previous     research has shown that patients with this condition tend to use healthcare services more     frequently and are often at risk of other diseases such as diabetes mellitus and high blood     pressure. Currently, the mainstay of treatment is noninvasive ventilation (NIV), this is a     mask ventilator that patients use overnight to improve oxygen levels and remove carbon     dioxide (the waste gas of breathing), however this does not fully treat the underlying     problem. The research group has shown that NIV helps improve activity and contributes to     weight loss in this group of patients. The aim of this research will be to investigate the     effect of an exercise and nutrition programme in addition to NIV on weight loss and activity     levels compared to NIV alone.   "
137598|NCT01483703|"     The purpose of this study is to determine whether reflections of light can be used to provide     real-time pictures of blood vessel formation around infants' heads. This study device is     called laser speckle imaging.   "
137599|NCT01483690|"     This is a pilot study using decitabine and vorinostat before and during chemotherapy with     vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with     acute lymphoblastic leukemia (ALL).   "
137600|NCT01483677|"     The investigators believe that subjects who practice on the Nintendo Wii will improve their     laparoscopic skills more than those who practice on the Playstation2.   "
137601|NCT01483664|"     The purpose of this study is to improve the communication skills of physicians who transition     lymphoma cancer patients from the end of treatment to survivorship.   "
137602|NCT01483651|"     The purpose of this research study is to test how different levels of insulin block the     effect of glucagon. Insulin is a hormone that lowers blood glucose. Glucagon raises blood     glucose. Both are natural hormones made by people without diabetes. Sensor-based blood     glucose control studies have been done by our research group using glucagon in small doses to     prevent hypoglycemia (low blood sugar). However, sometimes glucagon does not work to raise     blood sugar. The investigators believe this is because of too much insulin in the body. This     study will help determine how different levels of insulin in the body affect the ability of     glucagon to raise blood sugar.   "
137603|NCT01483638|"     The purpose of this study is to evaluate the maintenance therapy with axitinib in patients     with metastatic colorectal carcinoma   "
137604|NCT01483625|"     The aim of the study is to investigate whether the early introduction of maintenance     bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on     the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier     in their disease state and start maintenance therapy, if appropriate.   "
137605|NCT01483612|"     BACKGROUND: Obesity increases the risk of polycystic ovary syndrome (PCOS), characterized by     anovulatory cycles, but it is also associated with reduced fertility even in ovulatory women.     Moreover, obesity increases the costs of assisted human reproduction (AHR) treatments and     reduces their efficacy. In addition to fertility disorders, obesity increases significantly     the risks of many complications of pregnancy, delivery and neonatal health. However, a modest     loss of 5-10% of total body weight can restore ovulation and improve pregnancy rates.      OBJECTIVES: 1) To design and implement a multidisciplinary program for lifestyle management     of obese women, or overweight women with PCOS, who seek fertility treatment in a secondary     AHR center. 2) To evaluate lifestyle benefits of this program and assess its impact on     fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group     and to similar women seen in tertiary AHR centers. 3) To assess cost per live birth, and     other measures of cost-effectiveness, of this program compared to the control group and     tertiary AHR centers. 4) To effectively transfer knowledge obtained through these activities     to relevant stakeholders in the health care and public health sectors.      METHODS AND APPROACH: In order to design the program for lifestyle management of obesity in     infertile women, we will gather a Committee composed of members of our interdisciplinary     research team and relevant collaborators. Objectives 2 and 3 - In order to achieve these     objectives, 128 obese women (BMI ≥ 30 kg/m²), or overweight women with PCOS (BMI ≥ 27 kg/m²),     consulting at the CHUS fertility clinic will be randomized to our lifestyle program, and will     suspend fertility treatments for six months, or to standard fertility treatments, which are     directly initiated. The results obtained will also be compared to those of women with the     same criteria who will consult in 3 tertiary AHR clinics not offering a similar lifestyle     management program.      IMPACT: This project is very important as it will generate new knowledge about the     implementation, impacts and costs of a new lifestyle management program in obese infertile     women. Our project will obtain valuable data on implementability of such a program; on     benefits with regard to lifestyle, fertility and maternal and foetal complications during     pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness ratio.   "
137606|NCT01483599|"     The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the     treatment of patients with moderate to severe plaque psoriasis.   "
137607|NCT01483586|"     This research is being done to evaluate the safety and efficacy of the investigational     Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.   "
137608|NCT01483573|"     This study was designed to answer 3 primary research questions:        1. In adults with low back pain, reduced SLR ROM (Range of Motion) and a positive          sensitized SLR (Straight leg raise) test, does neurodynamic mobilization result in          greater SLR ROM, pain reduction and perceived improvement than muscle stretching?        2. In adults with low back pain, reduced SLR ROM and a negative sensitized SLR test, does          muscle stretching result in greater SLR ROM, pain reduction and perceived improvement          than neurodynamic mobilization?        3. In adults with low back and reduced SLR, does neurodynamic mobilization or muscle          stretching result in greater SLR ROM, pain reduction and perceived improvement          irrespective of the outcome of SLR sensitization?      The research hypotheses are threefold:        1. Subjects determined to have nerve-related pain and ROM restrictions by a positive          sensitized SLR test would benefit more from neurodynamic mobilization than muscle          stretching.        2. Subjects determined to have muscle-related pain and ROM restrictions by a negative          sensitized SLR test would benefit more from muscle stretching than neurodynamic          mobilization.        3. Subjects would benefit the same from muscle stretching and neurodynamic mobilization          when not matched on the outcome of the SLR sensitization.   "
137609|NCT01483560|"     The trial is conducted in the UK, Australia, Canada, Denmark and the Netherlands. The aim is     to test whether 3 years treatment with metformin added to titrated insulin therapy (towards     target HbA1c7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid     IMT, in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for     cardiovascular disease.   "
137610|NCT01483547|"     The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien)     in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI)     and Return of Consciousness (ROC) in neurosurgical patients are compared to those of     non-neurosurgical patients, during routine anesthesia procedures.   "
137616|NCT01483469|"     This open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as     radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to     human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III,     positron emission tomography (PET) assessments of specific uptake of the radiotracer and     whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part IV,     subjects will receive RO4917523 orally daily for 14 days while receiving three single     intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is     up to 4 weeks.   "
137617|NCT01483456|"     Falls among elderly inpatients are common, multifactorial and associated with a significant     increase of complications and morbidity. According to a recent Cochrane review, the     effectiveness of fall prevention program has been assessed in community-dwelling and in long     stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study     aims to measure the impact of a multidisciplinary prevention program on falls in elderly     inpatients.   "
137618|NCT01483443|"     This is a prospective phase III trial to define the role of oophorectomy in metastatic     colorectal cancer patients with ovarian metastasis.   "
137619|NCT01483430|"     In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on blood     pressure in prehypertensive or stage I hypertensive patients.   "
137620|NCT01483417|"     Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus     conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS     is not inferior to that of conventional approach.   "
137621|NCT01483404|"     This project investigates wether the intra-capsular hematoma, that often occurs after     fracture of the femural neck, decreases the capillary blood flow of the caput femoris.      During operation the measuring device of the O2c-machine in placed on the joint capsula first     and afterwards, after surgical opening of the capsula, on the femur directly. The integral of     the microcirculation of both parts of the femur is measured in both settings. So the     capillary blood flow is measured with the hematoma still in situ, eventually putting pressure     on the caput femoris and after the capsula has been opened, the pressure relieved and the     hematoma removed. Both measurements are compared for each patient.      The O2c-machine measures non-invasive with light waves and laser-doppler. The sounding rod is     packed in a sterile tube to prevent any contamination of the operation site.   "
137622|NCT01483391|"     Children or teens with mood swings or depression who have a parent with bipolar disorder are     at high risk for developing bipolar disorder themselves. This study will test a family-based     therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk     children (ages 9-17). In a randomized trial, the investigators will compare two kinds of     family-based treatment (one more and one less intensive) on the course of early mood symptoms     and social functioning among high-risk children followed for up to 4 years. The investigators     will examine the effects of family treatment on measures of neural activation using     functional magnetic resonance imaging.   "
137623|NCT01483378|"     The purpose of this study is to determine if vaccination rate of eligible patients at a major     urban public hospital will increase by having ophthalmologists screen patients for     eligibility and a nurse administer the vaccine in the General Eye Clinic.   "
137624|NCT01483365|"     The investigators are going to examine prospectively the need of luteal support after NC-FET.   "
137625|NCT01483352|"     The Accu-Chek DiaPort system enables continuous intraperitoneal insulin infusion (CIPII):     that is, infusion of insulin into the peritoneal cavity using an Accu-Chek insulin pump and     an infusion set. The Accu-Chek DiaPort consists of a metal body with a catheter that is     placed in the abdomen. The opening of the port is raised above the surface of the skin about     5 millimeters, while a flower-shaped plate is placed under the skin, providing stability for     the port. The port has been designed for those diabetics who cannot benefit fully from     subcutaneous insulin infusion. The primary objective of the study is to assess the     suitability of Accu-Chek DiaPort to perform continuous intraperitoneal insulin delivery. The     data collection focuses on the condition of tissue around the port after the implantation,     possible peritoneal reactions to the port system, and the peritoneal delivery of insulin.     Secondary objectives are the assessments of therapeutic performance and successful     implementation of design requirements. In total 12 Patients will participate in this open,     mono-centre, single-arm, interventional clinical trial. The study lasts 9 months (without run     in period of 3 to 1 week) separated in two parts. Phase I last 12 weeks. Phase II last 6     month until the end of the study. During the study, seven visits are planned. The screening     visit can take place up to 3 weeks before study start. At the implantation visit which can     last up to 5 days the port will be implanted. After the implantation insulin therapy will be     adjusted for CIPII and the patients will be trained for handling and daily care of the     Accu-Chek DiaPort system. To check the functionality of the system, the first control visit     will take place 2 weeks and the second control visit 6 weeks after the implantation. At the     week 12 visit, the most important parameters will be collected for the phase I report. The     following visits take place 6 and 9 months after the implantation.   "
137626|NCT01483339|"     Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.     However, the majority of treated patients remain symptomatic. The metacognitive therapy by     Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this     study is to investigate this approach with a randomized controlled trial by comparing     metacognitive therapy with exposure and response prevention for obsessive-compulsive     disorder.   "
137627|NCT01483326|"     This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra     (tocilizumab in participants of the ACT SURE clinical trial and further patients with     moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be     collected from each patient for up to 4 years.   "
137628|NCT01483313|"     Animal studies showed that many general anesthetics might result in neuron apoptosis and     neurocognitive impairment in the developing brain. However results from human studies are     conflicted. In present study, the investigators examined the association between early     exposure to anesthesia and surgery for minor surgery and intelligence changes in adolescence     using the Wechsler Intelligence Scale for Children.   "
137629|NCT01483300|"     Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line     treatment for metastatic breast cancer patients, especially for those previously treated with     anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum,     has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal     reaction. The purpose of the study is to compare the efficacy and safety of     gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast     cancer.   "
137642|NCT01483131|"     Resistance exercise plus vascular occlusion may induce greater improvements in strength and     muscle mass than resistance training alone. The investigators speculate this training     strategy could be beneficial in patients with osteoarthritis.   "
137630|NCT01483287|"     IBS (irritable bowel syndrome) is a functional gastrointestinal disorder which is     characterized by recurrent pain and/or discomfort, altered stool form, and abdominal     distension. It has been established that food items such as beans, peas, lentils, peppers,     and onions can increase gas production. What these have in common is that they all contain     large amounts of complex carbohydrates. The enzymes in the small intestine are not able to     fully digest these large molecules, which in turn are fermented by the colonic microflora.     This fermentation is conducted through the production of short chain fatty acids and gases     such as hydrogen and methane. Alpha-Galactosidase is an enzyme that has the ability to break     down these indigestible carbohydrates to galactose and sucrose in the small intestine and to     facilitate the absorption and minimize the gas production from bacteria in the colon.      The aim of this study is to assess if the gastrointestinal symptoms, above all problems from     gas and distension, is alleviated when the enzyme α-Galactosidase (present in Nogasin     capsules) is ingested with food.   "
137631|NCT01483274|"     Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell     transplant cell receive decitabine to up regulate cancer antigen expression, followed by a     donor lymphocyte infusion and an autologous dendritic cell (DC). Vaccine Dendritic cells are     pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.   "
137632|NCT01483261|"     To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with     Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This     study seeks to fill this gap by designing, implementing and testing such an intervention     using both an intervention and waiting list control group.   "
137633|NCT01483248|"     Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage     liver diseases. However, the critical shortage of donor organs, high cost, and the problem of     immune rejection limit its clinical application, and even some patients on the waiting list     will never survive to receive a matched liver. Stem cell transplantation instead of     conventional medical therapy or orthotopic liver transplantation will be a promising     alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs)     are generally thought of as an autologous source of regenerative cells in previous studies.In     this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for     patients with liver cirrhosis will be evaluated.   "
137634|NCT01483235|"     Standard cardiac rehabilitation programs (sCRP) aim to improve risk factors for heart disease     such as high blood pressure, weight control, exercise and diet in order to decrease the     chances of having heart problems in the future. These programs decrease morbidity and     mortality but face important challenges: 1) Long waiting lists to participate in these     programs. For example, St. Paul's Hospital has an intake capacity of 480 patients per year.     Patients usually wait one to three months to start the program. 2) There is a vast     heterogeneity of patients within the same program, from those that have never experienced     heart problems to those that have already had a heart attack, chest pain or stroke.     Therefore, patients with different medical problems receive the same treatment. 3) Facilities     can be inconveniently located which leads to transportation difficulties, 4) The program is     time consuming and classes are held in working times, 5) Shortly after completion, patients     seem to lose what they have gained in the program. These caveats need to be addressed to     improve the efficacy, delivery and capacity of sCRP for the increasing population of patients     with heart disease.      The investigators want to compare a reduced cardiac rehabilitation program (rCRP) with the     standard cardiac rehabilitation program (sCRP) in patients with risk factors for heart     disease as well as patients that already suffer from this condition, including those at     higher risk. The rCRP will offer the same services as the sCRP; the only difference is the     number of hospital based exercise sessions. While the sCRP offers 32 hospital based     supervised exercise sessions, the rCRP will offer 10 hospital based exercise sessions. The     rCRP would be a 'middle of the road alternative program' that would have the benefits of a     hospital based program and the flexibility of a home based intervention. The rCRP would offer     an alternative for patients that do not need constant supervision and would allow the sCRP     health care team to focus on those patients who have more serious heart conditions. The rCRP     would be a unique intervention because it integrates a less intensive cardiac rehabilitation     into the pre-existing sCRP model. This alternative would help overcome the caveats of     standard cardiac rehabilitation programs.   "
137635|NCT01483222|"     The main objective of this study is to investigate the efficacy of two different design     characteristics of lumbar support for low back pain prevention in hospital nurses.   "
137636|NCT01483209|"     The goal of this project is to determine if performing a chemical sympathectomy by     injecting botulinum toxin A in critically ill patients on vasopressors can treat digital     ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of     concept. We propose to study patients in the intensive care units of Duke Hospital who,     secondary to exposure to vasoactive medications used to maintain acceptable blood pressures,     have developed signs and symptoms of digital ischemia. A paired T-test will be used to     compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will     again use a paired t-test to compare the experimental hand against the contralateral control     hand. There were no major adverse events reported by the product information sheet or in     other related studies of Botox for digital ischemia.   "
137637|NCT01483196|"     This clinical trial studies vascular and cognitive assessments in patients with breast cancer     undergoing chemotherapy after surgery. Learning about vascular and cognitive function may     help plan treatment and improve the quality of life of breast cancer patients. Transcranial     Doppler ultrasound (TCD) may help study the side effects of chemotherapy in breast cancer     patients and allow doctors to plan better treatment   "
137638|NCT01483183|"     The purpose of Part 1 of this study is to determine the maximally tolerated dose of     OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).      The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of     OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.   "
137639|NCT01483170|"     This trial will study the tolerability and pharmacokinetic of fexinidazole using two     different dosage regimen of repeated administrations. The drug is administered to human     healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with     a loading dose during 4 days.   "
137640|NCT01483157|"     Resistance exercise plus vascular occlusion may induce greater improvements in strength and     muscle mass resistance training alone. The investigators speculate this training strategy     could be beneficial in patients with rheumatoid arthritis.   "
137641|NCT01483144|"     The purpose of this randomized, double-blind, Phase III trial is to determine if the     combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single     agents in delaying time to the first occurrence of any FAP-related event. This includes: 1)     FAP related disease progression indicating the need for excisional intervention involving the     colon, rectum, pouch, duodenum and/or 2) clinically important events which includes     progression to more advanced duodenal polyposis, cancer or death.   "
137643|NCT01483118|"     The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual     cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary     purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin     resistance in larger group of study subjects.      Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing     age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming     pregnant. The syndrome can also be associated with more serious conditions such as heart     disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome,     scientific studies showed that having too much insulin can be one of the reasons. In fact,     almost every overweight woman with PCOS has been found to have high insulin levels.      Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may     also reduce the body's insulin level. Another study showed that daily use of cinnamon for     forty days lowered the blood sugar level in patients with diabetes. Our own study also showed     that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The     purpose of this study is to see if cinnamon can help women with PCOS have more regular     periods.   "
137644|NCT01483105|"     The proposed study is designed to utilize a self-hypnosis DVD home-training program for     parents to use with their children to teach self-hypnosis techniques for inducing relaxation     and hypnotic analgesia. These relaxation techniques can be employed to manage anticipatory     anxiety, distress, and pain during an invasive medical procedure, for example, voiding     cystourethrography (VCUG). The study will examine the efficacy of this intervention for     children undergoing VCUG procedures.   "
137645|NCT01483092|"     Prebiotics are non-digestible food ingredients that beneficially affect the host by     selectively stimulating the growth or activity of species in the colon that can improve host     health.      Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic     activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results     in an increase in bacterial biomass and the production of SCFA (acetate, propionate and     butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant     amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat     (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2     and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since     inulin and oligofructose are used by the food industry either as sucrose and fat replacements     or due to their health benefits for the human host.      Several human absorption studies evaluated the effect of inulin/oligofructose on mineral     absorption. It was shown that calcium and magnesium absorption was positively influenced.     Until now, the positive effect on iron absorption was only shown in animals. The influence on     human iron absorption was investigated twice. Both studies reported no effect of     inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived     study designs.      The aim of the present study is to demonstrate that inulin consumption over several weeks can     lead to enhanced iron absorption in humans under optimized conditions.   "
137646|NCT01483079|"     Human milk feeding is associated with great benefits to the health and development of     infants, especially in premature infants. Some mothers are unable or unwilling to provide     breast milk to their infant. The use of donor human milk products for very low birth weight     infants as an alternative to cow milk has risen dramatically in the past year.      Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal     to 1250 grams birth weight receiving an exclusive human milk protein diet.   "
137647|NCT01483066|"     The currently held belief is that total knee replacement (TKR) requires the restoration of     the overall limb alignment to coincide with the mechanical limb axis. To align the knee     implants with this mechanical axis, rods are used to orient cutting guides with the     mechanical axis as defined by the center of the femoral head and talus. Standard surgical     technique typically involves femoral and tibial rods with cutting blocks to facilitate the     intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the     method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting     Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places     a plastic cutting guide on the end of the femur and tibia, so that cuts that do not     automatically default to the mechanical axis, but rather attempt to recreate the patient's     anatomic alignment. The surgeon can then assess implant placement and adjust as necessary     during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better     control over the placement of the implants.      This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary     TKR in a consecutive series of patients who meet the eligibility criteria. The clinical study     will be accompanied by a formal cost-effectiveness analysis of one-year outcomes.      One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee     System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to     reproduce the natural kinematic alignment of the knee. The other half of the cases will     receive the Triathlon® CR device in a procedure using traditional instrumentation, without     navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated     using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1 and     2 years postoperatively.      Primary Hypothesis:      The investigators expect that ShapeMatch Technology will be as cost-effective as usual care.      Secondary Hypotheses:      The investigators expect that ShapeMatch Technology will result in improved clinical outcomes     relative to usual care at three months postoperatively.      The investigators expect that ShapeMatch Technology will result in similar clinical outcomes     relative to usual care at two-years postoperatively.   "
137659|NCT01482910|"     This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into     the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual     function in Chinese subjects with age-related neovascular or wet age-related macular     degeneration.      Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both     treatment groups will receive the other treatment as a sham procedure.   "
137660|NCT01482897|"     The specific aim of this study is to determine whether a medical intervention improve status     of patients with discal sciatica and if yes which type of intervention.   "
137661|NCT01482884|"     The study is designed to evaluate the clinical efficacy and safety of tralokinumab as     compared to placebo. Investigational product will be administered as subcutaneous injection.     All patients will continue background therapy for ulcerative colitis as per local standards     of care in addition to investigational product.   "
137662|NCT01482871|"     The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal     injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint     of this study is observation of dose limiting toxicity and maximum tolerated dose. The     secondary endpoint of this study is observation of a clinical effect in BCVA (ETDRS letters)     and OCT central macular thickness.   "
137955|NCT01479036|"     This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and     epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer     patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy     to chemotherapy could further benefit breast cancer patients.   "
137648|NCT01483053|"     There is strong evidence that patients with major depressive disorder (MDD) are at increased     risk of developing coronary heart disease (CHD). This elevated risk is independent of     classical risk factors such as smoking, obesity, hypercholesterolemia, diabetes and     hypertension. The risk of CHD is increased 1½-2 fold in those with minor depression and 3-4½     fold in subjects with MDD. Put simply, the relative risk of developing CHD is proportional to     the severity of the depression. While the mechanism of increased cardiac risk attributable to     MDD is not known disturbances in autonomic function most likely do play a part.      In untreated patients with MDD (with no underlying CHD) the investigators have identified     that a marked sympathetic nervous activation and diminished heart rate variability (HRV)     occurs in a proportion (approximately one third) of patients. Diminished HRV has been linked     to increased incidence rates of acute cardiac events in conditions such as hypertension,     diabetes and myocardial infarction. Importantly, whether treating depression actually     improves the risk of: (1) CHD development or (2) recurrence of cardiac events in patients     with existing CHD remains unknown.      The investigators, and others, have provided a growing body of evidence linking elevated     sympathetic activity and exaggerated sympathetic responses to stress to early stages of end     organ dysfunction and markers of disease development. Of particular note, in addition to     possible effects on HRV is the association of chronic sympathetic nervous activation to: (a)     abnormal blood pressure regulation and (b) the development of insulin resistance.      The investigators therefore plan to examine the cardiovascular effects of two different     antidepressant medications, agomelatine and escitalopram, in patients with MDD. In addition,     the investigators plan to investigate the effects these two medications have on sympathetic     nervous system activity, blood pressure, HRV, endothelial function, metabolic and     psychological effects.      Findings from this study will assist us to identify of biological correlates of sympathetic     nervous activation which will enable us to: (1) identify those at potentially increased     cardiac risk, and (2) potentially implement additional therapeutic strategies in order to     reduce cardiac risk. Indeed, it is not known whether antidepressant treatment alone would be     sufficient to reverse any adverse effects of sympathetic nervous activation. This study aims     to answer this important clinical question.   "
137649|NCT01483040|"     The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video     monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract     includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum.     The device is introduced rectally, as with any standard colonoscope when indications     consistent with the need for the procedure are observed in the adult patient population.      The purpose of this prospective clinical study is to establish the usability of the PeerScope     B System™ when used during standard colonoscopy procedure.      The study population is comprised of patients indicated for colonoscopy.      The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary     endpoints:        1. The first secondary endpoint is the incidence of complications using the PeerMedical          colonoscope.        2. The second secondary endpoint is successful therapeutic interventions as biopsies,          polypectomies, APC etc.        3. The third secondary endpoint is the procedure time.        4. The fourth secondary endpoint is the subjective evaluation of the additional view angle          by the physician.        5. The fifth secondary endpoint is patient satisfactory.   "
137651|NCT01483014|"     This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant     treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of     imatinib to convert a tumor from inoperable to operable.   "
137652|NCT01483001|"     Lung Cancer (LC), colorectal cancer (CRC) and breast cancer (BC) are the major killers in     oncology, accounting for about 40% of cancer deaths. Although progresses have been made in     the last few years, unfortunately no patient with metastatic disease can obtain a definitive     cure.      A recent hypothesis is that cancer is driven by a small subpopulation of cells called cancer     stem cells (CSCs) or tumor initiating cells with an unlimited proliferative potential and     the ability to reproduce the original human tumor in experimental animal models. These cells     are thought to be responsible for the development of the tumor and represent the only cell     population able to sustain tumor growth and progression.      Therefore, CSCs represent the elective target for new targeted therapies, endowed with high     and selective toxicity towards the tumor but harmless towards normal cells.      Current technologies allow us to isolate and expand in vitro the CSCs from tumor specimens,     testing their sensitivity to different anticancer drugs in a short period of time.      Therefore, there is the potential opportunity to identify LC, CRC and BC CSCs.This is a     prospective study assessing feasibility of CSCS isolation in LC, CRC and BC.      Patients with a previously performed diagnosis of LC, colon cancer or breast cancer with no     further standard therapy options, with a Karnofsky performance status of 100% and with tumor     tissue available will be considered eligible for the study. Tumor tissue will be collected     before study entry, i.e tissue obtained during a diagnostic or therapeutical procedure, like     surgery or biopsies with other purposes than the protocol. In vitro tumor sensitivity to     chemotherapy drugs will be tested on tumor cell cultures per each patient.      Drugs and their combination will be considered effective and if they kill ≥ 60% of tumor stem     cells in vitro test. By using cancer spheres the investigators will also generate orthotopic     xenograft models that recapitulate the parental tumor behaviour, including the aggressive     features and the invasiveness potential. Orthotopic injection technique will be assessed in 5     weeks-old NOD/SCID mice   "
137653|NCT01482988|"     The principal aim of this study is to establish if a polymorphism in a gene important for     innate immunity to fungi represents a significant risk factor for the development of Candida     colonisation and subsequent invasive candidosis in critically ill patients. Incorporation of     a screening programme onto a risk-based algorithm for critical care patients would allow more     effective targeting of molecular diagnostic tests, anti-fungal prophylaxis and targeted     treatment. Sequential critical care patients will be screened for gene polymorphisms and     undergo regular screening for Candida colonization.   "
137654|NCT01482975|"     The overarching objective of this research is to prevent substance use in early adolescents     through the use of innovative interactive interventions tailored to each individual's     particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test     the effectiveness of the computer-based profile-based tailored interventions to keep early     adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the     computer-based profile-based tailored interventions to keep early adolescents from using     alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet     and physical activity interventions will be effective in reducing these two high risk     behaviors as part of the comparison condition.   "
137655|NCT01482962|"     This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib     compared with single-agent treatment, as selected by the investigator from the offered     options of pralatrexate or gemcitabine or romidepsin, in patients with relapsed or refractory     peripheral T-cell lymphoma (PTCL). Note: romidepsin will not be used as a single-agent     comparator in countries that do not permit its use at this time.   "
137656|NCT01482949|"     The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination     with sunitinib therapy.   "
137657|NCT01482936|"     This is a single center, open label, randomized, parallel group single dose intravenous     (i.v.) administration study. The subjects will be randomized to receive a single dose of     OxyNorm® 2.5, 5, and 10mg.   "
137658|NCT01482923|"     A treatment session especially for PLWHA to help them discuss and take action about their     smoking may be useful.   "
137939|NCT01479244|"     Purpose of this trial:        1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine®          (sargramostim, GM-CSF).        2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control          subjects.   "
137663|NCT01482858|"     This study aims to evaluate the safety and analgesic effect (efficacy) of Gastrolith powder     (GASP) on skeletal pain caused by osteoporotic vertebral compression fractures (OVCF) versus     placebo, primarily as assessed by the Numeric Rating Scale (NRS), and Brief Pain Inventory     (BPI). It is also intended to evaluate disability change with the Oswestry Low Back Pain     Disability Index (ODI) and to evaluate whether GASP consumption leads to reduction in     analgesic standard of care (ASOC) versus placebo, using weekly analgesic consumption diaries.   "
137664|NCT01482845|"     This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20     male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's     disease on stable doses of acetylcholinesterase inhibitors.   "
137665|NCT01482832|"     The Specific Aim of this proposal is to conduct a randomized controlled trial to evaluate     whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a     didactic attention-control program reduces the risk of PPD in adolescent mothers.      Primary Hypothesis:        1. The intervention (Project REACH) will be significantly more efficacious than the control          program in reducing the risk of PPD up to six months postpartum in adolescent mothers.           Secondary Hypotheses:        2. The decreased rate of major depression in the Project REACH group compared to the          control program group will be sustained through one year postpartum.        3. Adolescent mothers in Project REACH compared to the control program group will have          higher levels of maternal-child bonding.   "
137666|NCT01482819|"     The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial     bleb response to wearing galyfilcon A lenses in asian eyes.   "
137667|NCT01482806|"     Depression and anxiety are common in primary care practice and are associated with     substantial reductions in health-related quality of life. This Project will test the     comparative effectiveness of two on-line treatments for these conditions provided through the     context of a Collaborative Care program: (1) moderated access to a proven-effective     computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT     plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of     these treatments to PCPs' usual care for these conditions, and evaluate the adoption and     maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a     greater understanding of how to best scale the delivery of these interventions into a variety     of primary care settings.   "
137668|NCT01482793|"     The objective of this study is to gather data regarding the efficacy, safety and     cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures     less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all     vertebroplasties.      The primary effectiveness analysis will be based on the number of patients whose numeric     rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks     post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly     larger proportion of patients achieving pain reduction than the control group. A secondary     analysis will compare the change in mean pain scores and specific activity related pain     scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary     effectiveness analysis will include the mean change in the back-pain specific limitation in     function as quantified by the Roland Scale at these same data collection time points.   "
137669|NCT01482780|"     The aim of the study is to analyze the potential of pressure controlled intermittent coronary     sinus occlusion (PICSO) to prevent/reverse the ischemic burden as well as reperfusion injury.     To achieve insight into the clinical significance of this local preconditioning effect,     global hemodynamics, cardiac performance and clinical outcome in the first 30 days will be     related to the ability of this intervention to protect the myocardium in elective surgical     procedures, ameliorating cellular decay and preserving the microcirculation therefore     improving graft flow, reducing enzyme leakage and finally improving myocardial performance.   "
137670|NCT01482767|"     Hepatitis C virus (HCV) infection is a leading cause of death and illness in people with     HIV-1. At the time the study was designed, the standard treatment for people with HIV-1 and     HCV coinfection included two drugs: pegylated-interferon alfa 2b (PEG-IFN) and ribavirin     (RBV). The purpose of this study was to evaluate the effectiveness of giving boceprevir (BOC)     together with standard treatment in treating HCV infection in people with HIV-1 and HCV     coinfection.   "
137671|NCT01482754|"     This is an observational prospective cohort study design to evaluate the safety of rapid     Rituximab infusion at 90 minutes for Non-Hodgkin Lymphoma (NHL) patients. The secondary aim     is to measure the number of rejected chemotherapy administration on schedule. Non-Hodgkin     lymphoma patients who tolerated well for at least 2 cycles of standard infusion of Rituximab     without grade 3 or 4 adverse events will be recruited in the study. In this study, the first     20% of the total dose of rituximab will be administered over 30 minutes. When subjects     tolerate the infusion and stable vital signs, the remaining 80% of the total dose will be     administered over 60 minutes. Prior administration of Rituximab, premedication will be given     to the subjects including PO Paracetamol 1g, IV Diphenhydramine 25/50mg and/or IV     Hydrocortisone 100mg. The duration of subjects involvement in the study approximately takes     72 hours. Adverse events that occur within the first 24 hours of infusion will be evaluated     if related to Rituximab infusion as some subjects are receiving combination chemotherapy with     rituximab. This study will recruit both in patients and out-patients. A phone call to monitor     subject's health will be made post 24, 48, 72 hours of rituximab infusion. The findings from     this study will add evidence to the safety of rapid Rituximab infusion at 90 minutes. If the     outcome is favourable, NUH will consider adopting the new infusion rate for Rituximab     infusion for patients who tolerated at least 2 cycles of standard infusion recommended by the     drug manufacturer.      The study hypothesizes that rapid Rituximab infusion at 90 minutes is safe for NHL patients.   "
137865|NCT01480219|"     The primary objective of the study is to assess the relationship (both crude and adjusted)     between voriconazole utilization and the development of non-melanoma skin cancer among adult     patients who received a lung or heart/lung transplant and were continuously enrolled in a     large U.S. commercial health plan.   "
137940|NCT01479231|"     The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in     Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton     Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of     GERD on the location of esophageal eosinophilia.   "
137672|NCT01482741|"     Risks from imaging-related radiation exposure have become a popular topic in the media.     Because these tests are commonly applied to patients at a cancer center, it is important to     understand what patients know, how they feel about what they know, where they get their     information, and how satisfied they are with available risk-benefit communication on this     topic.      The purpose of this study is to understand how cancer patients perceive risks and benefits of     diagnostic radiation and their satisfaction with healthcare communication on this topic.   "
137673|NCT01482728|"     The purpose of this study is to see if the investigators can measure inhibition of a protein,     Src (named for Sarcoma), in tissue and blood in patients with a diagnosis of endometrial     cancer. Dasatinib is a drug that blocks the activity of an important protein in cancer cells     called Src. The investigators can measure the blocking of Src in the bloodstream. However,     the investigators do not know if measures in the bloodstream reflect blockage of Src in     cancer tissue. The investigators are doing this study to try and see if the investigators can     match what the investigators see in cancer tissue to what the investigators see in the     bloodstream. the investigators hope that in the future, the investigators can use blood to     measure protein inhibition by dasatinib instead of asking patients to undergo repeat     biopsies.   "
137674|NCT01482715|"     Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate     the safety of different doses and dosing regimens of oral rucaparib administered daily to     patients with solid tumors.      Part 2A (Completed Enrollment) and Part 2B (Currently Enrolling) - The purpose of the second     part of the study is to determine the safety and clinical activity of the RP2D of oral     rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or     somatic).      Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further     evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid     tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).   "
137675|NCT01482702|"     Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese.     The American Cancer Society has called for weight loss treatment to be standard of care for     overweight women with breast cancer. During therapy women with breast cancer often gain     weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have     their cancer come back. The reason why overweight breast cancer survivors are more likely to     re-occur has not been well studied, but changes in how insulin works may contribute.     Overweight survivors are also at risk for the other chronic diseases associated with obesity.     Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of     chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the     internet has been developed at the University of Vermont. This successful intervention has     not been tested among breast cancer survivors. Given that women tend to lose muscle mass     during cancer therapy the addition of a resistance training component to the weight loss     intervention may be important. Therefore the overall goal of this project is to pilot test a     proven distantly- delivered behavioral weight loss intervention among overweight breast     cancer survivors and to evaluate whether a resistance program results in improvements in lean     body mass, while studying how both interventions change insulin sensitivity.      Specifically, this project is a randomized, controlled clinical trial designed to test the     effectiveness and acceptability of a 6-month behavioral weight loss intervention with and     without resistance training. Participants will be randomized to one of two groups: 1)     behavioral weight control treatment via the Internet; or 2) behavioral weight control     treatment via the Internet plus a resistance training program. Women eligible to participate     include overweight breast cancer survivors who are age 50 or older and 6-36 months past     receiving chemotherapy. Assessments will be conducted at baseline and six months and will     include measures of body weight, muscle mass, adherence to treatment, and insulin     sensitivity.   "
137676|NCT01482689|"     The main aim of the present study is to compare the bioavailability of vitamin D from cod     liver oil and multivitamin tablets given to healthy individuals under the same conditions, as     well as to study the influence of gender and ethnicity on vitamin D absorption. Healthy     subjects will be randomised into two parallel groups receiving 10 micrograms (400 IU) per day     of vitamin D3 from one fish oil capsule or one solid multivitamin tablet, respectively. Serum     samples will be drawn at baseline and after four weeks (28 days) for the analysis of     25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone, and tartrate resistant     acid phosphatase in serum.   "
137677|NCT01482676|"     Urgency, frequency and incomplete emptying are the key symptoms of lower urinary tract     dysfunction, including bladder pain syndrome/interstitial cystitis, and overactive bladder     syndrome. Lower urinary tract dysfunction is associated with cellular stress, leading to     changes in gene expression and consequent organ remodeling. MicroRNAs are small regulatory     molecules, affecting protein synthesis. They are quickly winning recognition as potential     therapeutic agents. The investigators will perform a comparative study of mRNAs changed in     lower urinary tract dysfunction and address the role of differentially expressed miRNAs in     regulation of the genes, important for bladder function. The experimental approach, combining     the analysis of human biopsy material with the in vitro cell-based models, will allow the     investigators to elucidate the effects of miRNAs on the expression of receptors, contractile     proteins and tight junction proteins. Once the disease-induced miRNAs have been characterised     and their target genes validated, it will be possible to influence their expression levels     thus counter-acting their effects.      The investigators' work addresses fundamental mechanisms of signal transduction in urothelium     and smooth muscle during cellular stress caused by inflammation or bladder outlet     obstruction, and its regulation in the diseased state. The investigators' findings will     further the knowledge of the molecular mechanisms of lower urinary tract dysfunction and have     implications for diagnosis and treatment. Additionally, they have relevance for other     clinical conditions, where miRNAs are implicated.   "
137678|NCT01482663|"     Hand eczema is a common disease which often gives a chronic course thus affecting many     functions in daily life. The body of evidence related to self-management of chronic hand     eczema is poor. Better methods to support self-management of patients with chronic hand     eczema may potentially improve the prognosis of a disease which is both a tremendous burden     to the individual and to the society. The purpose of this trial is to evaluate the effect of     a newly designed guidance programme offering individual counselling compared to conventional     information with written information sheets.   "
137719|NCT01482130|"     The current guidelines emphasize the prevention of bone loss, by building up bone mass in     young age, as one of the most important measures to reduce the incidence of osteoporosis.     Strength training and explosive exercises have been shown to have beneficial effects on     bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis     concludes that it is still unclear what type of exercises, intensity and execution that is     most effective for skeletal adaptations. The following study will examine the effect of 12     weeks of heavy, explosive strength training on bone mineral density and bone metabolism in     young, healthy girls aged 18-30 years.   "
137720|NCT01482117|"     The aim of this study is to investigate the effects of genetic polymorphisms on     pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean     healthy adult volunteers.   "
137679|NCT01482650|"     The investigators have performed a number of studies on novel airway devices, including an     observational study on the performance of a new supraglottic airway named Baska mask. In this     new proposed study the investigators would like to compare directly,in a randomized clinical     trial, this device with the device the investigators routinely use - the single use laryngeal     mask airway - LMA, in female patients undergoing general anaesthesia.      This study will determine which device performs best, as measured by key parameters     (insertion success rate, seal pressures, time to and ease of insertion, failure rate,     complications etc) as regarding the performance and safety profile of the Baska mask and the     LMA.      The investigators have two study hypotheses, namely (1) non-inferiority of first placement     attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.      A number of secondary endpoints will be monitored and analyzed (time to and ease of     insertion, failure rate, complications etc).   "
137680|NCT01482637|"     In this study, the investigators seek to further develop the CAS as a comprehensive,     reliable, and valid instrument for measuring coercion to participate in research among adult     substance abusing offender populations.   "
137681|NCT01482624|"     The primary objective of this clinical investigation is to determine whether     post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can     relief pain, improve mobility and promote joint recovery, compared to the standard     arthroscopy procedure alone, in patients undergoing arthroscopic procedure.   "
137682|NCT01482611|"     The purpose of this study is to investigate the safety, tolerability and plasma     pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food)     from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a     JNJ-47910382 plasma level that approaches the predefined maximum mean exposure (whichever     comes first) in healthy Caucasian and Japanese participants. The foreseen maximum dose is 600     mg. In addition, the effect of fasting (ie JNJ-47910382 is taken without food) on the plasma     pharmacokinetics of JNJ-47910382 after one selected oral dose given to healthy Caucasian     participants will be studied. JNJ-47910382 is a drug that is being developed to treat     Hepatitis C infection and is an inhibitor of the reproduction machinery of the Hepatitis C     virus (HCV). Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream,     distributed in the body and eliminated from the body.   "
137683|NCT01482598|"     The Study Purpose is to demonstrate the superiority of optimized remote patient management     compared to optimized standard care in the management and prognosis of heart failure, in the     prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the     reduction of inappropriate shock therapies. The remote care allows early intervention in     terms of drug therapy adjustment and cardiac resynchronization therapy (CRT‐D) device     reprogramming.   "
137684|NCT01482585|"     to determine the values of imaging and genetic biomarkers for prediction of tumor     aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify     unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the     long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a     guideline for planning an appropriate follow-up examination and management   "
137685|NCT01482572|"     The purpose of this study is to evaluate the feasibility of aspiration samples for mutational     analysis in patients with a non-small cell lung cancer (NSCLC).   "
137686|NCT01482559|"     The HIP trial is a large pragmatic, multinational, randomised trial of two different     strategies for the management of hypotension in extremely low gestational age newborns     (Standard with dopamine versus a restricted with placebo approach).      HYPOTHESIS: A restricted approach to the management of hypotension in extremely low     gestational age newborns will result in improved neonatal and long-term developmental     outcomes.      PRIMARY OBJECTIVE: To determine whether a restricted approach to the management of     hypotension compared to using dopamine as first line pressor agent in infants born less than     28 weeks of gestation within the first 72 hrs after birth (transitional period), improves     survival without significant brain injury at 36 weeks postmenstrual age (PMA) and improves     survival without moderate or severe neurodevelopmental disability at 2 years corrected age.   "
137687|NCT01482546|"     Hypothesis: Novice trainees will achieve significantly higher clinical competence and patient     satisfaction scores with the use of warm water infusion method when compared with traditional     air insufflation      Primary outcome: adenoma detection rate      Secondary outcomes: (1) independent cecal intubation rate, (2) trainer assessment of     trainee's colonoscopy skills, (3) trainee's assessment of clinical confidence, (4) procedural     medication requirement, (5) patient pain level during procedure, (6) patient satisfaction at     procedure completion, and (7) patient willingness to repeat procedure'      Specific Aim: To demonstrate the stated hypothesis via above outcome measures. The long term     goal is to provide evidence to influence other training institutions to consider education in     the warm water infusion method'   "
137688|NCT01482533|"     The main purpose of this study is to compare the effectiveness and accuracy of tissue     cultures and swab cultures to diagnose prosthetic joint infection.   "
137689|NCT01482520|"     All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted     therapy will be candidates for the study.      No additional treatment or intervention will be conducted except for blood sampling that will     be limited to one time only.      Blood samples (10 cc in volume) will be collected from all study participants once they     provided written informed consent form. DNA will be extracted from peripheral blood samples     using DNA isolation kit.   "
137690|NCT01482507|"     Diffusion Weighted Imaging (DWI) MRI will assist in differentiating poor prognosis bone     oedema more effectively than traditional T2 weighted MRI in patients with early Rheumatoid     Arthritis (RA).   "
137740|NCT01481857|"     Proprioceptive training has been shown to be effective in increasing the efficiency of     motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that     proprioceptive support do influence in the activation of the transversus abdominis muscle     (TrA) during segmental stabilization training.   "
137741|NCT01481844|"     The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI +     amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and     tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole +     tetracycline ) as second line treatment of H. pylori .   "
137691|NCT01482494|"     The adult onset form can occur between the second and sixth decades of life as a form of     proximal myopathy, predominantly in the pelvic girdle area. Sometimes the first symptoms are     shortness of breath and diaphragm weakness which herald progressive proximal muscle weakness.     The heart and liver are not affected.      Serum CK (Creatine Kinase) activity is 2 to 10 times higher than normal. EMG (electromyogram)     testing usually reveals a myopathic pattern and muscle biopsy may show vacuoles containing an     accumulation of glycogen that is not broken down.      Until fairly recently, an assay of acid maltase activity using cultured fibroblasts after     biopsy of skin or muscle tissue was required for diagnosis, as leukocytes contain a renal     isoenzyme that is not absent in these patients and which can mask the deficit and result in     false negatives. In recent years this problem has ben solved by the introduction of acarbose,     an inhibitor of renal α-glucosidase; it is also used in the dried blood spot method, which     measures acid maltase activity using maltose and acarbose as inhibitors and     4-methylumbelliferyl-D-glucopyranoside as substrate.   "
137692|NCT01482481|"     Background: Nurses in clinical practice implement care to patients with Type 2 diabetes     mellitus (DM2) in order to maintain normal blood glucose readings, promote weight loss and     provide nutrition counseling to improve metabolic and blood pressure control. Because many     disciplines contribute to patient's health outcomes, it is important to distinguish how     nurses contribute to patient care and the achievement of health outcomes and the differences     between the use or not the classification of Nursing Diagnoses, and the Nursing Interventions     Classification (NIC) in clinical practice settings.      Methods: Prospective observational study with 2-year follow-up to assess the effect of     Nursing Care Plans based on Scientific Methodology (NCPSM) on changing the control parameters     in routine clinical practice conditions.      Settings: 31 Primary care centers in northeastern urban area of Madrid (Spain). Subjects:     24,124 DM2 patients (full universe).   "
137693|NCT01482468|"     The purpose of this study is to determine whether continuous infusion of palonosetron after     its prophylactic single injection can further reduce the incidence of postoperative nausea     and vomiting in patients undergoing gynecological laparoscopic surgery.   "
137694|NCT01482455|"     There is a current debate whether impaired insulin-mediated microvascular perfusion limits     the delivery of hormones and nutrients to muscle and whether short term FFA elevation affects     transcapillary transport of insulin and glucose thereby representing a rate-controlling step     for insulin-stimulated muscular glucose disposal in humans.      To address these questions, the investigators determined the changes of interstitial glucose     and insulin in skeletal muscle of healthy volunteers during intravenous administration of     triglycerides or glycerol under physiologic and supraphysiologic hyperinsulinemic conditions.   "
137695|NCT01482442|"     The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium     microspheres is more effective on overall survival in advanced Hepatocellular carcinoma (HCC)     with or without portal venous obstruction and no extrahepatic extension than sorafenib which     is now the standard treatment of advanced HCC.   "
137696|NCT01482429|"     Prolongation of mechanical ventilation poses serious personal and financial threats to     healthcare consumers.      The investigators objectives are create and implement an multidisciplinary evidenced-based     ventilator-weaning protocol to assess whether a systematic approach compared with the     physician's judgment only decreases time spent on the ventilator, complications of mechanical     ventilation and length of stay in critical care unit.   "
137697|NCT01482416|"     The aim of this study is to evaluate the vascular effects of estrogens on climacteric women     measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound     and compare to placebo.   "
137698|NCT01482403|"     This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will     evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in     combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C     infection. The anticipated time on study treatment is up to 48 weeks.   "
137699|NCT01482390|"     This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained     virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with     telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with     chronic Hepatitis C infection.   "
137700|NCT01482377|"     This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety,     pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or     erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive     solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599     as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in     Part C) followed by an extension phase for each part.      In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled     RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo     biodistribution and organ pharmacokinetics of RO5479599.   "
137701|NCT01482364|"     The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then     applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management -     IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure     monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e.     without IHM) during a 6 months intensive treatment program.   "
137702|NCT01482351|"     The goal of the research is to determine the power and the feasibility of the study design     and methods to inform a full-scale clinical trial that will determine whether treatment of     obstructive sleep apnea in older adults with mild cognitive impairment delays cognitive     decline and preserves everyday function.   "
137703|NCT01482338|"     The purpose of this study is to determine whether low-dose combine oral contraceptives (COC)     containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of     Premenstrual symptoms.   "
137704|NCT01482325|"     The primary objective of this study is to show that the noninvasive blood pressure software     algorithm meets engineering requirements.   "
137705|NCT01482312|"     The purpose of this study is to evaluate two different types of contact lenses and their     effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.   "
137909|NCT01479647|"     The purpose of this study is to investigate the effect of food on the time course of     PH-797804 concentration in the blood following dosing by oral immediate release tablet     formulation.   "
137706|NCT01482299|"     This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free     survival rate (primary end-point) and response rate, toxicity, overall survival and biomarker     assessment (secondary end-points) in patients with metastatic or recurrent gastric cancer     with pS6 Ser 240/4 expression.      Eligibility criteria include pathologically proven non-resectable adenocarcinoma of stomach     with measurable disease who failed previous first-line palliative chemotherapy including     fluoropyrimidine and platinum with high expression of pS6 Ser 240/4.      Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted     according to the observed clinical toxicities. Treatment will be continued until disease     progression or patient's intolerability to the study drug.      A study requires 40 assessable subjects to decide whether the proportion of patients who are     free from progression at 4 months (16 weeks), P, is less than or equal to 0.1 or greater than     or equal to 0.25 with a target error rate of 0.05 and β of 0.2. If the number of responses is     7 or less, the hypothesis that P >= 0.250 is rejected with a target error rate of 0.200 and     an actual error rate of 0.182. If the investigators assume that drop-out rate is 10%, total     accrual patient will be 45.   "
137707|NCT01482286|"     Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of     reproductive age and despite decades of research the etiology the disorder is not known. The     characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine     function and insulin resistance. Obesity is a common correlated phenotype of Polycystic ovary     syndrome and weight gain worsens the reproductive and metabolic complications. Currently     there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet     weight loss by dietary restriction and regular exercise are strongly advocated. Weight loss     and increased insulin sensitivity appear to drive improvements in reproductive outcomes in     women with Polycystic ovary syndrome; however, the mechanism connecting these changes with     the reproductive axis is not fully understood.   "
137708|NCT01482273|"     Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for     developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to     more distal DVT. There's evidence that the early removal of the obstructing thrombus by     catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher     degree of thrombolysis is associated with lower incidence of PTS, better quality of life and     lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced     thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency,     low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs     accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however     the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally     assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis     reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic     ilio-femoral DVT.   "
137709|NCT01482260|"     Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous     malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression     profiling using microarrays.   "
137710|NCT01482247|"     The purpose of the study is to employ the supplement L-arginine to test the hypothesis that     activation of blood flow to the brain during cognitive tasks is regulated by nitric oxide in     older subjects with diabetes mellitus and/or hypertension (high blood pressure).   "
137711|NCT01482234|"     The purpose of this study is to assess whether text messages can be used as a way to increase     the amount of physical activity teens get each day.   "
137712|NCT01482221|"     The purpose of this study is to assess the effect and safety of AZD6765 in patients with     major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a     channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.   "
137713|NCT01482208|"     Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration     status in newborns and infants by means of ultrasound velocity measurements through muscle     tissues. Changes of tissue hydration will be followed during first days of life in newborns     and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical     dehydration symptoms will be used as controls.   "
137714|NCT01482195|"     A recombinant adeno-associated virus serotype 2 (rAAV2) vector has been altered to carry the     human MERTK (hMERTK) gene. This vector has been shown to restore vision in animal models that     resemble human MERTK-associated Retinitis Pigmentosa (RP), an incurable retinal degeneration     that causes severe vision loss. The proposed study is an open label, Phase I clinical trial     of subretinal rAAV2-VMD2-hMERTK administration to individuals with MERTK-associated retinal     disease. This trial will lead to a greater understanding of the safety and thereby potential     value of gene transfer in MERTK-associated retinal disease and will have implications for     other forms of retinal degenerative disease amenable to this type of intervention.   "
137715|NCT01482182|"     In this prospective study, the investigators will evaluate and compare the usefulness of     functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the     palliative chemotherapy with the aim of predicting tumor response and prognosis in patients     with advanced Non-small Cell Lung Cancer (NSCLC).   "
137716|NCT01482169|"     The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to     intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.   "
137717|NCT01482156|"     Study has two parts:        1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety          and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in          patients with advanced solid tumors.        2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in          patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer   "
137718|NCT01482143|"     The aim of this study is to characterize the pharmacokinetics and safety/tolerability of     AFQ056 in children with Fragile X Syndrome(FXS)   "
137742|NCT01481831|"     This purpose of this study is to evaluate the efficacy and safety of single and repeated     doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and     highly emetogenic chemotherapy in patients.   "
137910|NCT01479634|"     A study of antiretroviral therapy (ART) initiation under a streamlined model of care in     HIV-positive patients with CD4+ cell counts greater ≥ 250 cells/uL   "
137721|NCT01482104|"     Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a     slow-growing tumour which despite low metastatic potential may cause significant local tissue     destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy     (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week     apart. This procedure is considered quite time- and resource-consuming. Introducing a single     treatment session, with a new PDT session for treatment failures after 3 months, might     represent an attractive simplification.      This randomised controlled single-blinded multi-centre study primarily aims to compare BCC     lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with     re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard     Metvix(R) PDT treatments 1 week apart.      Secondary objectives are to investigate the treatment response in relation to clinical and     histological tumour characteristics such as tumour thickness, subtype and immunohistochemical     markers.   "
137722|NCT01482091|"     The purpose of this study is to determine if intranasal fentanyl can decrease the pain of     patients with sickle cell disease who present to the pediatric emergency department with a     vaso-occlusive crisis.   "
137723|NCT01482078|"     Magnesium is a treatment for mothers to protect brains of babies born early. This study     investigates combined effects of magnesium and spinal or epidural anesthesia on mothers     having cesareans.      The investigators will use a scoring system to measure sedation and devices that subjects     breath in and out of to measure breathing strength.      The investigators hypothesize the combination of magnesium and anesthesia will reduce     breathing strength and cause sedation.      This is an observational study comparing those having magnesium and anesthesia with those     just having anesthesia. Routine medical care will not be altered.      Results will hopefully allow anesthesiologists to provide better patient care.   "
137724|NCT01482065|"     This research is being done to examine: 1) how common obstructive sleep apnea (OSA) is in     patients with non-alcoholic fatty liver disease (NAFLD), 2) whether the severity of OSA is     related to the severity of NAFLD, and 3) whether treatment of OSA with continuous positive     airway pressure (CPAP) improved NAFLD progression.      OSA is a condition caused by repetitive collapse of throat tissue during sleep that leads to     falls in oxygen level and sleep disruption. OSA can be caused by obesity, and especially by     fat found in the neck and belly.      NAFLD is a common disease linked to obesity. NAFLD is part of a disease spectrum, which can     progress from steatosis (fatty liver) to nonalcoholic steatohepatitis (NASH), a progressive     fibrotic disease, in which cirrhosis and liver-related death can occur. Recent evidence in     patients with obstructive sleep apnea (OSA) indicates that OSA is associated with NASH. How     common OSA is in patients with biopsy-confirmed NAFLD and the effect of OSA treatment with     CPAP on NASH is unknown.   "
137725|NCT01482052|"     The purpose of this study is to evaluate the safety of a new conjugate vaccine,     NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal     A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of     antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine,     as a measure of vaccine effectiveness.   "
137726|NCT01482039|"     The investigators propose a prospective evaluation of methods to assess cervical length for     uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for     routine mid pregnancy ultrasound. The investigators hypothesize that a sequential approach to     screening of the cervix (which consists of initial transabdominal evaluation first with     transvaginal ultrasound reserved only for those patients in whom the cervix appears short on     transabdominal exam or when adequate views cannot be obtained with the transabdominal     approach alone) will take less time, will result in the same number of adequate views of the     cervix and will have higher patient satisfaction that a universal transvaginal screening     approach.      OBJECTIVE      To determine the best strategy for cervical length screening in uncomplicated singleton     gestations between the gestational ages of 18-28 weeks.      Primary outcome:      1) Time required to obtain adequate views of the cervical length.      Secondary outcomes:        1. Patient satisfaction with ultrasound experience as measured by patient questionnaire        2. Number of adequate views of the cervix obtained with each approach      STUDY DESIGN      This is a prospective study to compare strategies for cervical length measurements in     uncomplicated singleton gestations seen in the MFM office for routine mid pregnancy fetal     well being ultrasound between 18-28 weeks gestation. The different strategies include 1)     Transabdominal assessment of the cervix (current standard), 2) Sequential evaluation of the     cervical length (transabdominal followed by transvaginal if necessary due to short cervix or     inadequate transabdominal views), and 3) Transvaginal cervical length assessment. Patients     with an uncomplicated singleton gestation presenting for a routine mid pregnancy ultrasound     between 18-28 weeks will be randomized into one of the three groups noted above after consent     is obtained. Ultrasound examination will then take place and data collected. The various     strategies listed above will be compared for the following:        1. Time required to obtain views of the cervix             1. Time from initiation of exam to completion of cervical assessment             2. Time for completion of entire exam        2. Patient satisfaction             1. Comfort/Discomfort of exam procedure             2. Overall impression of exam process        3. Number of adequate views of the cervix obtained      Maternal demographics including age, parity, weight, height and due date/gestational age will     also be obtained for all consenting patients.   "
137727|NCT01482026|"     The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients.     Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for     one of the most important in terms of frequency and psychosocial and educational     consequences.      In these conditions, our study was designed to estimate the sensitivity to changes of the     different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will     then optimize our methodological approach for a therapeutic trial.   "
137728|NCT01482013|"     This is a safety and tolerability study investigating the effect of HPP854 in subjects with     mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess     the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic     relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.   "
137729|NCT01482000|"     The purpose of this study is to compare the exercise capacity and pulmonary function test     parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care     with and without pulmonary daoyin therapy of China in community.   "
137730|NCT01481987|"     Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral     Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane     (ERM).      Design: Cross sectional case-control series.      Methods:      Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic     ERM and twenty-seven healthy patients (27 eyes) as a control group.      Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography     (SD-OCT).   "
137731|NCT01481974|"     The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary     efficacy of a five-days post-operative course of Treprostinil in liver transplant patients.      The hypothesis of this study is that Treprostinil can be safely administered post-operatively     in liver transplant patients. Once safety is documented future studies will address its     ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and     thereby reduce morbidity, leading to shorter hospital stays as compared to historical     controls.   "
137732|NCT01481961|"     The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS)     applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early     Alzheimer's disease (AD).      This study included 15 patients treated with rTMS and whose medication reference is     stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected     in the MCRR of Besançon and the psychiatric department of the University Hospital of     Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using     the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS),     State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety     Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized     by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued     Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test     (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96),     Rey-complex figure test-copy and Picture naming 80 items test (DO80).      Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25     seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A     psychometric assessment will be conducted again at the end of treatment week and one month     after stopping treatment. A neuropsychometric assessment will be conducted one month after     stopping the treatment. Scales of comfort and acceptability will also be proposed to the     patient to determine whether any gene is caused by this treatment. Moreover a questionnaire     will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and     4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy     Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily     Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of     recent change of the personality (CP6).      The population of this study will be comprised of patients between 60 to 85 years-old with     early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be     recruited on a voluntary basis, after notification and consent in the research center. This     study was conducted over a period of 15 months.   "
137733|NCT01481948|"     The purpose of this project is to reduce health disparities in obesity risk among 8-10 year     old African American girls using a culturally sensitive and developmentally appropriate     internet-based program with no face-to-face interaction. This study will conduct an outcome     evaluation to test short and longer term effects on obesity risk.   "
137734|NCT01481935|"     The purpose of this study is to determine whether extra cleaning of frequently-contaminated     surfaces in intensive care rooms is effective in preventing contamination of disposable     isolation gowns and gloves with multi-drug resistant bacteria.   "
137735|NCT01481922|"     This study is intended to help guide the choice of needle diameter when performing a lumbar     puncture.      Smaller spinal needles have been shown to decrease rate of adverse events such as post-lumbar     puncture headache and hearing loss.      The main drawback to using smaller needles is diminished flow rate; some textbooks recommend     using needles no smaller than 22 gauge because of the slow flow rate though others recommend     smaller needles, namely 22-24 gauge.      Some authors have described a successful use of spinal needles as small as 25 gauge when     performing a lumbar puncture.      The investigators do not believe that the flow-rate difference between 22 and 24 gauge     needles is significant enough to justify using the larger needles.      The investigators trial will compare the Whitacre 22 gauge and Whitacre 24 gauge needles for     flow rate, and incidence of the known complications of pain during procedure and backache at     8 and 15 days post-procedure.      The investigators will also look at whether smaller needles are associated with less pain     during the procedure and less backache the next 2 weeks after the procedure.   "
137736|NCT01481909|"     Study title:      An exploratory, randomised, double-blind, placebo controlled crossover study to assess the     efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.      Study code:      SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to § 40     Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité,     Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1,     D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical     Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Monitoring     Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin Berlin,     Charitéplatz 1, D-10117 Berlin Clinical phase Phase II      Primary objective:      Reduction of wheal and flare type skin reaction after standardised provocation testing     assessed by volumetric and thermographic measurements.      Secondary objectives:      Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as     assessed by symptom score, DLQI, Itchy-QoL and VAS.      Study design:      An exploratory, randomised, double-blind, placebo controlled crossover study      Type and number of patients:      Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic     mastocytosis with skin involvement      Main criteria for inclusion:      Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid or     other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode of     administration 20 mg Rupatadine or placebo before provocation testing, oral administration     (tablets)      Duration of treatment:      28 days (testing will be done at the day of last treatment)      Assessment of efficacy:        1. Assessment of wheal and flare development by planimetric analyses of digital          photographic, volumetric, and thermographic imaging (time lapse) before and after          treatment with study medication,        2. Additional assessment of symptoms,        3. Assessment of life quality      Main criteria of evaluation:      Efficacy   "
137737|NCT01481896|"     This retrospective study will review the Anderson Orthopaedic Institute's initial experience     among a consecutive series of 126 patients who had primary total hip arthroplasty using a     metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled     with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels, cup     orientation, osteolysis, radiographic implant stability and clinical outcome measures     including component revision, complications, patient satisfaction and Harris Hip Scores will     be evaluated.   "
137738|NCT01481883|"     The aim of this project is to investigate the effect of Raloxifene 120mg in men with     schizophrenia. This trial will adopt a 12 week randomised controlled model.      Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators (SERM)     will have a significantly greater reduction in psychosis symptoms over the course of the     study than men receiving adjunctive placebo.      Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater     improvement in cognitive function than men receiving adjunctive placebo   "
137739|NCT01481870|"     The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with     cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve     progression free survival and overall survival in a comparative study with interferon-alpha.     When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is     one of the treatment options after disease progression. Reversely, when sorafenib is used as     first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of     cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this     study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy     and treatment switched to the other test drug, sorafenib or sunitinib, when disease     progression is detected to assess which treatment sequence produces longer progression free     survival and offers a better safety profile (causing fewer adverse events). The purpose of     this trial is to compare progression free survival of first line sunitinib versus sorafenib,     and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib     followed by sunitinib.   "
137743|NCT01481818|"     Radiodermatitis and radiation mucositis were the most frequent side-effect during the course     of radiotherapy, especially when concurrent chemoradiotherapy applied. Since reactive oxygen     species formed upon radiation therapy play a central role in initiating and driving the     detrimental signaling events, antioxidant supplementation is thought to provide a     photoprotective effect against radiation. Green tea extract has been shown to have     antioxidant and anti-inflammatory effects on various types of cells. To evaluate the safety     and efficiency of green tea extract in the treatment of radio dermatitis and radiation     mucositis, the investigators conducted this phase Ⅰ,II study using topical EGCG in cancer     patients receiving radiotherapy or concurrent chemoradiotherapy .   "
137744|NCT01481805|"     To explore biomarkers predictive of clinical response to sorafenib in unresectable     hepatocellular carcinoma using the Prometheus Platform To analyze expression and activation     status of receptor tyrosine kinases in signal transduction pathways in FNA samples and     circulating tumor cells.      To identify negative predictive markers to sorafenib. To elucidate signal transduction     pathway attributable to sorafenib resistance. To monitor changes in the RTK activation status     during sorafenib treatment using circulating tumor cells.      To analyze correlation between the quantity of circulating tumor cells and circulating     endothelial cell precursors and treatment response to sorafenib.   "
137745|NCT01481792|"     Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for     lamellar resection (ReLEx smile) in the reduction of myopia.   "
137746|NCT01481779|"     The purpose of this study is:        -  To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of          treatment.        -  To compare the number of night time low blood sugar episodes on LY2605541 with insulin          glargine during 78 weeks of treatment.        -  To compare the number of participants on LY2605541 reaching blood sugar targets without          low blood sugar episodes at night to those taking insulin glargine after 78 weeks of          treatment.        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin          glargine after 78 weeks of treatment.   "
137747|NCT01481766|"     The pre-school years are critical years for children to acquire early learning skills such as     language, fine motor and social skills; this is termed early child development. Primary care     doctors (family doctors and pediatricians) are in a unique position to identify children with     health or developmental problems. Screening is the process of testing healthy people for the     earliest signs of health problems, followed by treatment, with the expectation that screening     will improve the health of those screened. The focus of this research is screening young     children for the earliest signs of iron deficiency (low blood iron levels) followed by     treatment with oral iron.      Previous research has shown that children with later stages of iron deficiency have serious     delays in their development. Some research has shown that these delays may persist into young     adulthood often with a significant reduction in intelligence. Early stages of iron deficiency     may be difficult for parents or doctors to detect, and a blood test is usually needed.     However, Canadian guidelines do not recommend screening all children for iron deficiency,     because there is not enough good quality research to prove that screening is effective.      In this study, the investigators will ask parents to allow their child between the ages of 1     to 3 years to have a blood test for iron levels. If the blood level is low, the child will be     randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a     placebo liquid plus diet counseling. A psychologist will measure each child's early learning     ability before and after the treatment. If this approach to screening children's blood iron     levels followed by treatment improves children's development, parents and doctors may     consider that routine blood screening tests are justified. Overall, this research is an     important step to improving the ways in which primary care doctors can ensure that children     have the best start to life-long health and achievement.   "
137748|NCT01481753|"     The investigators plan to perform a prospective randomized, head-to-head trial to test the     hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy     (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or     Delayed Gastric Emptying (DGE).   "
137749|NCT01481740|"     Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35).     This subgroup of patients represents a large portion of the obstetric patient population     locally and nationally. It is unclear whether previous research should be extrapolated to the     obese patient population. This study is being done to compare the incidence of hypotension,     intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive     a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the     treatment of established hypotension. This study will help us determine whether using a     phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal     induced hypotension during cesarean deliveries in obese patients.   "
137750|NCT01481727|"     The purpose of this study is to evaluate the efficacy of high-intensity non invasive     mechanical ventilation (during one year to reduce the severity and frequency of acute     exacerbation of chronic obstructive pulmonary disease (AECOPD) in patients with frequent     AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very     severe COPD). The design is a randomised, double blind and controled with placebo (sham     maneuver) clinical trial.   "
137751|NCT01481714|"     An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of colonoscopy.     Failure to adequately cleanse the bowel for colonoscopy can lead to missed lesions, prolonged     procedure duration and repeated procedures at earlier intervals. Emerging solid evidence is     pointing out the need of switching from preparation the day before to regimens in which half     or even more of the preparation is administered the same day of the procedure, which have     extensively demonstrated to provide a significantly better cleansing, being well tolerated.     Preparation can be fully administered the same day for afternoon procedures, whereas     split-dose regimens fit better with morning colonoscopies. However, the ideal regimen for     early morning colonoscopies is still to be elucidated. The second part of the preparation for     these patients is usually recommended to be taken during sleeping time (2-3 am) on the belief     that intake of fluids should be completely halted at least four hours prior to the     colonoscopy procedure Sodium picosulphate is a unique orange-flavoured cleansing agent dosed     as two powder sachets. Mayor advantages in comparison with current alternatives are     relatively small volumes (each sachet is mixed with only 150-250 mL of water) and a more     pleasant taste. It provides similar bowel cleansing than sodium phosphate and polyethylene     glycol solutions administered the day before. Nonetheless, focus on split-dose regimens has     been set on several polyethylene glycol (either high-volume or low-volume) regimens, but no     data are available for split-dose sodium-picosulphate regarding colonoscopy in adults.      The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate     low-volume split-dose regimen, in which the second-half of the preparation and fluids intake     are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning     colonoscopies, comparing this split-dose regimen with standard cleansing the day before with     sodium picosulphate/magnesium citrate.   "
137752|NCT01481701|"     This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant     tumors Folfox regimen.   "
137753|NCT01481688|"     The purpose of this study is to investigate whether intradialytic exercise increases removal     of waste products from blood, in comparison to the traditional prescription of increasing     dialysis duration.   "
137754|NCT01481675|"     To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb     (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.   "
137755|NCT01481662|"     SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss,     and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of     patients with SS, mostly young women, have been reported. However, comprehensive     epidemiological, clinical and etiological features of SS have never been specifically     addressed so far.      The objective of this study is to characterize the epidemiological, clinical, and etiological     features of SUSAC's Syndrome. In this aim, the investigators will constitute a national     clinical-based cohort including all SS cases retrospectively reported in France since the     last 20 years and all new cases prospectively observed. French Society of Neurology,     Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed     by an expert comity of internists, neurologists and neuroradiologists to validate the     diagnosis. The exhaustive and systematic analysis of each case will help to better define     different aspects of the disease such as the incidence and prevalence, the clinical     presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor     magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral     microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from each     patient will also be collected to study potential autoimmune, thrombotic and infectious     markers.   "
137756|NCT01481649|"     The purpose of this study is to determine whether preemptive nucleoside analogue therapy or     regular virologic monitoring is the preferred method in management patients with prior     exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation     (HSCT).   "
137757|NCT01481636|"     The purpose of this study is to investigate the correlation between health outcomes     associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings     will guide the design of interventional studies.   "
137758|NCT01481623|"     Type 1 Diabetes is a multifactorial disease, with a strong genetic contribution of HLA genes,     and minor contributions of many additional genes. The investigators hypothesis is that in     addition to multifactorial inheritance, there are subtypes of diabetes that are caused by     defects in single genes (monogenic diabetes). The aim of this project is to identify these     genes, based on detailed clinical and characterization of patients, and to describe the     corresponding genetic diabetes entities with respect to the genetic and molecular defect,     clinical features and biochemistry. Based on the investigators study design, most of these     diabetes entities will be caused by mutations affecting the two copies of the corresponding     gene. In addition, the investigators will study the relatives of the patients, and explore if     carriers of these genetic defects (i.e. only one copy of the gene being defective) may have a     predisposition to common forms of diabetes, mainly type 2 diabetes.   "
137759|NCT01481610|"     The purpose of this study is to determine whether the use of lumiracoxib in this particular     population is associated with a decrease in glomerular filtration rate (GFR) compared to     diclofenac; and to compare the magnitude of such impairment, if any, associated with use of     lumiracoxib and diclofenac.   "
137760|NCT01481597|"     Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic     antitumor activity. The purpose of the present study is to investigate the safety and     pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following     single-dose administration.   "
137761|NCT01481584|"     The objective of the study is to evaluate the nutritional and physiological properties of two     canola proteins focusing on the bioavailability in humans.   "
137762|NCT01481571|"     The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte     vitrification/warming media and the vitrification device Rapid-i™, when using vitrification     as a cryopreservation method for human oocytes.   "
137763|NCT01481558|"     This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects     of repeated transcranial direct current stimulation for the treatment of apathy in moderate     Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.   "
137764|NCT01481545|"     The purpose of this study is to evaluate the use of chemotherapy, radiation therapy and     bevacizumab before surgery in patients with locally advanced rectal cancer (LARC).   "
137765|NCT01481532|"     The primary objective of the study is to assess whether human subjects can be made tolerant     to intravenously administered Crotoxin and achieve higher and more therapeutically effective     doses levels without the previously reported adverse effects associated with bolus i.m.     administration.   "
137766|NCT01481519|"     Viral conjunctivitis causes redness, tearing, swelling, and irritation of the eyes that     typically lasts from 1 to 3 weeks. Current management of this condition focuses on supportive     care while the viral infection completes its course and resolves. However, many patients     still experience substantial discomfort despite standard treatments, and, given the     disproportionate morbidity and potential economic impact associated with an outbreak of     infective conjunctivitis, a therapeutic agent that reduces clinical symptoms of and minimizes     shedding of infectious virus would be desirable.      Povidone-iodine is an antiseptic extensively used in preparation for general surgery,     ophthalmic purposes, and laboratory disinfection. Dilute povidone-iodine solutions inhibit     numerous viruses, bacteria, fungi, and some other parasites. Low cost, effectiveness, and     lack of microbial resistance make povidone-iodine an appealing drug to treat ocular     infections, especially in developing countries. Previously studies showed that     povidone-iodine is a potential option to reduce contagiousness in cases of adenoviral     infections. Dexamethasone 0.1%/povidone-iodine 0.4% it is a mixture containing a steroid and     antiseptic is promising as a suitable therapeutic agent for the treatment of EKC. A small,     prospective, open-label, single-armed clinical trial of dexamethasone 0.1%/povidone-iodine     0.4% administration in humans with symptoms of acute conjunctivitis who tested positive for     adenoviral antigen was therapeutically successful. In other study, dexamethasone     0.1%/povidone-iodine 0.4% combination markedly lowered the viral concentration and improved     the manifestations of the disease.      So, the favorable human data in combination with in vivo results provide a strong impetus for     a human phase III clinical trial to test the efficacy of this drug in a larger group and also     to evaluate complete safety to properly establish the therapeutic benefit versus adverse     effect for these reasons, the investigators chose to study the efficacy of dexamethasone     0.1%/povidone-iodine 0.4% in treating the symptoms and signs of viral conjunctivitis. The     administration of dexamethasone 0.1%/povidone-iodine 0.4% can be a secure, tolerable and     affective treatment to inflammatory and infective component of acute viral conjunctivitis.   "
137767|NCT01481506|"     Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and     disease-related need of care. Selected interventions were able to reduce the number and the     severity of exacerbations. Telemedicine has also been proposed for this purpose. Current     evidences, however, are scant. The investigators present a randomized, parallel-group trial     of a multiparametric remote monitoring system to test its ability to improve early     exacerbation detection rates and impact on clinical outcomes.   "
137941|NCT01479218|"     The objective of the study is to investigate the safety, efficacy and clinical utility of the     Occlutech PDA device for closure of patent ductus arteriosus of all types.   "
137769|NCT01481480|"     A massive tear of the rotator cuff is a debilitating condition that causes pain, significant     impairments in strength, and resultant loss of activity of the affected arm. To our     knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive     rotator cuff tears. Adding the first randomized controlled trial to will be a substantial     contribution to the current body of evidence available in the subject of massive rotator cuff     tears. Most studies found in the literature following patients with massive rotator cuff     tears are retrospective, have small numbers of patients, offer no control group and do not     adequately compare treatment methods.Moreover, there is no consensus from experts regarding     which treatment is superior.      Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial     prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the     treatment of massive rotator cuff tears. This study will include the use of comprehensive     functional, motor and radiographic outcome assessments.   "
137770|NCT01481467|"     Influenza is a serious disease which can cause severe illness and even death among patients.     Health care workers (HCWs) often get infected with influenza and up to 76% of them keep     working while being ill. Immunizing HCWs is therefore an essential factor in protecting     patients from influenza as HCWs easily transmit influenza to their patients.      However, despite recommendations from the Dutch Health Council since 2007, vaccine uptake     among HCWs remains low.      The aim of this study is to develop an effective implementation strategy on the basis of     previous behavioural studies and to evaluate its value in a clustered randomized trial in all     Dutch University Medical Centers (UMCs). Also, we want to assess the program elements that     are associated with a higher vaccine uptake and the cost-effectiveness of such an     implementation strategy.      The results of this study will give more insights in the way influenza vaccination campaigns     should be directed in order to achieve high vaccine uptake rates among HCWs in hospitals.   "
137771|NCT01481454|"     The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine     (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune     response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).      Primary Objective:        -  To describe the safety profile (injection site reactions and systemic events) of each          vaccine during the 21 days following vaccination, and serious adverse events (including          adverse events of special interest) throughout the study in all adult and          child/adolescent participants.      Secondary Objectives:        -  To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine          (QIV) induce an equivalent immune response at 21 days post-vaccination in both age          groups (lot consistency)        -  To describe the compliance of the immunogenicity of QIV to the European Medicines Agency          Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.   "
137772|NCT01481441|"     With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised     with the potential to improve ultrasound imaging for prostate cancer detection and     localisation significantly. The past years numerous studies have been performed with CEUS,     all basing their results on subjective judgement of the investigator. CEUS image     interpretation is difficult and requires a well-trained expert. To overcome these     difficulties CEUS quantification techniques can be of use. The techniques used in this     protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e)     and BRACCO, Geneva.      The investigators hypothesize improvement of the PCa detection rate with quantification,     compared with subjective CEUS interpretation and known numbers in literature.      Also a comparison between quantification results and tumour differentiation grade (Gleason     score) will be made, the investigators hypothesize a positive correlation.   "
137773|NCT01481428|"     This study will be the first to examine the efficacy of using a brief, computerized HIV risk     reduction intervention in treatment courts.   "
137774|NCT01481415|"     The investigators study is trying to find the normal value to left atrial volume and left     atrial function in healthy children by tridimensional real time echocardiography avaluation.   "
137775|NCT01481402|"     Purpose: The purpose of the study is to examine if treatment with liothyronine increases left     ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.   "
137776|NCT01481389|"     The purpose of this study is to determine the effect of theobromine on blood lipid parameters     in healthy subjects. Secondary objectives are to determine the effect of cocoa and an     interaction effect of cocoa and theobromine on blood lipid parameters.      Hypothesis: theobromine has a positive effect on blood lipid parameters.   "
137777|NCT01481376|"     The objective of this retrospective study is to evaluate the postoperative clinical outcomes     at discharge, 1 month and 12 months, associated with the use of Parietex™ ProGrip™ in     Laparoscopic Transabdominal preperitoneal inguinal hernia repair. Results from this study     will be used to support the short- and long-term clinical outcomes of Parietex™ ProGrip™ when     used in inguinal hernia repair by laparoscopic approach.        -  Single center study        -  Population: All subjects have undergone Laparoscopic Transabdominal preperitoneal          surgical treatment for inguinal hernia repair with Parietex™ ProGrip™ without additional          fixation between September 2008 and March 2010 (inclusive) with at least 12 months of          follow-up.      The primary outcome:      • Proportion of subjects who experience hernia recurrence (defect treated initially with     Parietex™ ProGrip™) within 12 months post-surgery.      Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a     Valsalva maneuver in the operated groin.      The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the     recurrence diagnosis is confirmed during a physical examination by a physician and defined as     a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the     operated groin. If subject has a surgical repair of the hernia within the 12 month     postoperative period, it will be documented as evidence of hernia recurrence.      The secondary outcome:        -  Incidence of Groin Pain (pain score 0-10) and analgesic use at discharge, 1 month and 12          month postoperatively        -  Incidence of postoperative complications including, wound infection (any infection of          the incision), mesh infection (an infection of the mesh), bleeding, mesh migration, mesh          erosion, fistula, small bowel obstruction, seroma, hematuria, hematoma, inflammation,          chronic pains/ inguinodynia, infection, visceral adherence, allergic reactions to the          components of the product at discharge, 1month and 12 month post-operatively        -  Patient satisfaction        -  Operative time        -  Hospital length of stay   "
137797|NCT01481116|"     The purpose of this study is to determine the efficacy and safety of TAK-875, once daily     (QD), plus metformin compared to glimepiride plus metformin in participants with type 2     diabetes mellitus (T2DM).      The purpose of this study is to determine the efficacy and safety of TAK-875, once daily     (QD), plus metformin compared to glimepiride plus metformin in participants with type 2     diabetes mellitus (T2DM).   "
137925|NCT01479439|"     Sickle cell disease causes kidney damage with increasing age, leading to chronic kidney     disease and renal failure in nearly one third of patients with sickle cell disease.     Currently, there is no treatment for sickle cell related kidney disease.   "
137778|NCT01481363|"     Do family carers of people with dementia benefit from communication therapy and training?     This study will only involve carers of people with dementia. Nearly all people with dementia     will experience some difficulty communicating. Family carers of people with dementia have     described communication and associated behaviour difficulties as one of the hardest to cope     with.      This is a PhD study. The student/investigator has previously produced a detailed manual of     approaches for supporting relatives of people with dementia who are experiencing     communication difficulties. Previously published communication guides by other authors do not     present research evidence.      Carers will be recruited to this study from the local NHS older person's mental health     service overseen by their relative's psychiatrist. Only family carers will be included.     Recruits will be randomly assigned to a treatment group or a control group. People in the     control group will receive treatment as usual. The carers will be seen at home or at an NHS     site if they prefer. The investigator and carer will work through the contents of the manual     together. The manual is designed to consider their knowledge, thinking, skills and behaviour.     The treatment will take no more than 4.5 hours over a period of up to 12 weeks.      Carers will be asked to complete questionnaires before and after the treatment. As well as     background information, these questionnaires will look for any significant effects of the     treatment on carers' anxiety and depression, carers' quality of life, carers' belief in their     ability to care, communication difficulties experienced and the carers perceptions of their     relatives communication competence.      A sample of 15 carers will also be interviewed by a third party interviewer who will be an     existing speech and language therapy employee of Solent NHS Trust (see attached job     description and person specification). The interviews will ask more specifically about their     thoughts, feelings and opinions of this intervention and their experience in addressing     communication difficulties.   "
137779|NCT01481350|"     Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac     surgery for valvular heart diseases, especially in patients with a long life mitral valve     disease. The present study wants to test the hypothesis that intravenous administration of     sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.   "
137780|NCT01481337|"     The endoscopic management of patients on anti platelet agents is a wide problem more and more     common, with prevalence of patients on this type of therapy steadily increasing. The risk of     bleeding on antiplatelet during an endoscopic examination can be major. The risk of     cardiovascular thrombotic accident in dirty shutdown of anti platelet, was recently described     as significant (4-5%). Current recommendations for polypectomy allow the gesture as aspirin     and are based on literature data scarce, often retrospective. Such work may be for a lack of     increased bleeding risk during a colonic polypectomy under aspirin. There is to date no     significant data published on the implementation of the endoscopic mucosal resection     (mucosectomy) under aspirin. It is necessary to achieve a national multicenter observational     study on a large scale in the daily practice of colonic polypectomy / mucosectomy in patient     taking aspirin.      The aim of the study is to determine the incidence of immediate and delayed bleeding colonic     polypectomy and mucosectomy with aspirin. The patients undergoing colonoscopy and taking a     long-term aspirin therapy and presenting a major risk of thromboembolism or medium will     incluables. Inclusion will be achieved for those patients receiving aspirin colonoscopy after     signing a specific consent. Polypectomy will be possible according to the recommendations of     the French Society of Digestive Endoscopy. Upon discovery of a lesion to be resected by     mucosectomy, the patient will benefit from the mucosectomy. The study is observational,     multicenter, prospective, national. The polypectomies / colonic mucosectomies will be made     using the conventional techniques and the current recommendations. The immediate and delayed     hemorrhage meet specific definitional criteria. The number of patients to be included will be     1000. The duration of the study inclusions will be 36 months. The trial will be conducted in     full compliance with laws, regulations and ethical aspects.      It is expected in this work that the incidence of post-polypectomy bleeding under aspirin is     the same. The rate of bleeding reported in the post mucosectomy size is higher compared to     the polypectomy: it is however expected that the rate of bleeding in the post mucosectomy     with or without aspirin is indifferent. It will follow a recommendation of French society     adapted to endoscopy for this type of procedure   "
137781|NCT01481324|"     It has been shown that compliance with brace wear can significantly improve the treatment     outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be     around 30-41% with initial orthosis wear after successful treatment with serial castings.     These studies have depended on family logs and not objective data. With the development of a     monitoring device, this study hopes to examine: (1) actual patient compliance, (2)     comparisons of actual wear time and assumed wear time and (3) the relationship of patient     wear with clinical outcomes.      Hypothesis:      Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported     compliance and noncompliance is correlated to future surgeries.   "
137782|NCT01481311|"     The aim of this clinical investigation is to prove that the seca mbca detects dialysis     patients with abnormal water distribution correctly. Abnormal high water distribution is     defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and     Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects     generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution     methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method     should be evaluated to the accuracy of the absolute measurement of the volume state of     dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.   "
137783|NCT01481298|"     Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous     excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses     communicating with the ventricular cavity and severely altering myocardial structure.     Although most authors assume a developmental arrest in embryogenesis as the underlying     pathology, the mechanisms of LVNC are not fully understood yet. Several gene mutations have     been identified to be linked with LVNC and an autosomal dominant inheritance pattern is     frequent To date the most commonly used imaging tool for diagnosing LVNC is echocardiography     applying the criteria established by Jenni and coauthors However, qualitative parameters to     differentiate normal compaction of the myocardium in healthy subjects from LVNC or from other     cardiomyopathies like dilative cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) may     fail due to highly variable LV trabeculation. Therefore, absolute quantification should be     performed. Cardiac magnetic resonance (CMR) has been reported as a promising imaging modality     to characterize patients with LVNC as it provides both a high spatial resolution and a good     contrast between trabeculation and blood pool Jacquier et al. recently described a value of     trabeculated LV myocardial mass above 20% of the global mass of the LV to be highly sensitive     and specific for LVNC However, in their approach, a substantial degree of the LV cavity was     included into calculated trabecular LV mass and led to systemic overestimation of the latter.     Furthermore, the role and prognostic value of myocardial scarring as assessed by delayed     enhancement (DE) CMR was not evaluated.      The aim of the retrospective study was to establish revised and extended CMR criteria to     distinguish LVNC from DCM, HCM and a group of healthy controls and to improve the assessment     of trabeculated mass by excluding intertrabecular blood pool.   "
137784|NCT01481285|"     The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI     and FFMI is based on the results of two other clinical investigations: Generation of     prediction equation to analyze body composition of adults based on Bioelectrical Impedance     Analysis (BIA) (BCA-01) and Application and adaption of device specific body composition     formulas to various ethnic groups (BCA-02). The aim of BCA-01 was to develop prediction     equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods     ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the     other hand. The equations are necessary to use the device as a Body Composition Analyzer with     an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply     and adapt device specific body composition formulas to various ethnic groups.   "
137785|NCT01481272|"     It is expected that addition of anti-CD20 antibody - ofatumumab would enhance the activity of     the etoposide+ifosphamide with mesna+cytarabine+methotrexate+lenograstim or filgrastim (IVAC)     regimen. This study is planned to determine the efficacy and safety of ofatumumab in     combination with IVAC chemotherapy in patients with CD20 positive diffuse large B cell     lymphoma progressing or relapsed after prior R-CHOP chemotherapy not suitable for Autologous     Stem Cell Transplant (ASCT).   "
137786|NCT01481259|"     Maintenance therapy has been considered as an important component to prolong survival in     patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have     confirmed that pemetrexed is one of the effective drugs in improving progression-free     survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic     deliveries of pemetrexed, however,the functioning status and immune system may get worse,     which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with     autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism     through stimulating immune response and altering the interaction between tumor and its host.     This effect may result in improved tumor control and survival, as well as a better quality of     life. To test the hypothesis, a randomised controlled study was conducted to compare CIK     cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell     lung cancer.   "
137787|NCT01481246|"     The Neurocognitive Study for the Aging (NEUROAGE) was initially funded by the Cyprus Research     Promotion Foundation and has received subsequent funding by the European Union Regional     Development Fund. The project focuses on the understanding of the effects of age on     neurocognitive abilities such as attention, memory, language, categorization, and executive     functioning. In addition, it also investigates the effects of a theory-driven hierarchical     training program, the Categorization Program, to improve cognitive abilities in adults with     Mild Cognitive Impairment (MCI). Over 700 adults ages 50 and older participate in the     project. The grant was awarded to the University of Cyprus.   "
137788|NCT01481233|"     The purpose of this study is to determine the prostate specific antigen response to     continuous low dose oral colchicine.   "
137789|NCT01481220|"     Patients with Myelodysplastic Syndromes (MDS) often suffer from low platelet levels which may     lead to bleeding complications. Treatment with cytotoxic agents can decrease the platelet     levels further. Eltrombopag is a relatively new drug that increases the platelet level in the     blood by working directly on the bone marrow. It is available for treatment of the disease     Immunological Thrombocytopenic Purpura (ITP). In this study patients with MDS and low     platelet levels that are treated with the cytotoxic agent Azacitidine will also receive     Eltrombopag. The administration of Eltrombopag to MDS patients treated with Azacitidine may     result in less dose reductions and less treatment delays for Azacitidine and may reduce the     need for thrombocyte transfusions and lower the risk of bleeding complications.      This is a phase I study, meaning that our major goal is to investigate the safety and     tolerability for Eltrombopag in this patient group. It will also generate a basis for a phase     II-III-study.   "
137790|NCT01481207|"     Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition     characterised by acute or subacute brain injury arising from perinatal hypoxia. HIE is     thought to affect approximately 0.2% of live births, and is associated with a high risk of     mortality or long-term neurological disability.      Accurate biomarkers for long-term neuro-developmental outcome following HIE are extremely     important both for clinical management and the evaluation of therapeutic approaches.     According to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and     N-acetyl aspartate (NAA), two neuro-metabolites detectable with magnetic resonance     spectroscopy (MRS), currently represents the most accurate prognostic indicator of outcome     following HIE. However, for various technical reasons standard MRS methods do not offer     optimal sensitivity for detecting lactate, which may potentially be improved with a custom     lactate editing MRS sequence. In addition, while perfusion has also been suggested as a     potential biomarker for neuro-developmental outcome following HIE, due to a paucity of MR     perfusion imaging studies in neonates, the prognostic accuracy of perfusion MR measures has     not been evaluated in comparison with more established MR biomarkers. The aims of this study     are:        1. to evaluate the relative sensitivity of a custom lactate editing MRS pulse sequence          (specialist software) relative to the standard point resolved (PRESS) MRS sequence for          detecting lactate in neonates with suspected HIE.        2. to evaluate the sensitivity and specificity of MR perfusion measures in comparison to          MRS measures as predictors of neuro-developmental outcome at 2 years.   "
137791|NCT01481194|"     The purpose of this study is to evaluate the efficacy and safety of the combination treatment     of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide in newly     diagnosed multiple myeloma patients.   "
137792|NCT01481181|"     In low-income settings in developing countries unsafe water is one of the leading causes of     high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element     that has a critical role in growth and immunity. Supplementation with zinc is considered     effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard     Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called     LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological     contamination and enriches water with zinc at a concentration of 3.5 mg/L. The objective of     the study is to assess the efficacy of LSF to increase the zinc status (serum zinc     concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.The study     hypotheses are:      A. Use of the LSF device will reduce microbiological contamination of the household supply of     drinking and cooking water; B. Use of the LSF device will increase zinc intakes in preschool     children; C. Use of the LSF device will increase serum zinc concentration in preschool     children; D. Achieving A, B and C will improve growth in preschool children; E. Achieving A,     B and C will reduce the frequency and duration of diarrheal disease in preschool children and     in members of the participating households.   "
137793|NCT01481168|"     The purpose of this study is to determine whether or not the intravenous adenosine test     readily identifies patients with unexplained syncope who would benefit from permanent     pacemaker implantation.   "
137794|NCT01481155|"     The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy     is superior in the treatment of actinic keratoses with respect to efficacy and side effects.   "
137795|NCT01481142|"     The objectives of the study are to observe and document the efficacy and safety of 5 or more     Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of     ulcerative colitis patients. The patient subset of interest is those with moderate/severe,     steroid-dependent, active ulcerative colitis with insufficient response or intolerance to     immunosuppressants and/or biological agents.   "
137798|NCT01481103|"     This research is being done to study the effect of incorporating acupuncture into the     management of migraines. The primary aim is to determine in a randomized, controlled study     whether individuals experiencing migraines have fewer occurrences and less intense migraines     when acupuncture is integrated with nonprescription pharmacological treatment.     Nonprescription pharmacological treatment in this study refers to the use of the following     over the counter medications: Aspirin, Ibuprofen, Naproxen, Acetaminophen (with or without     caffeine). Aspirin, Ibuprofen, and Naproxen are members of a class of drugs known as     non-steroidal anti-inflammatory drugs or NSAIDs.   "
137799|NCT01481090|"     One of the most widely used procedures in reproductive medicine technologies is In Vitro     Fertilization (IVF). During the IVF procedure, there are sometimes unused embryos that are     frozen to be used at later times. If these embryos are thawed and transferred back to the     mother, proper development of the uterine lining plays an important role in outcome of     pregnancy. Electro-acupuncture (EA), a technique where electrical current is applied to the     needle to stimulate an acupoint, has been shown to increase uterine blood flow, increasing     the likelihood of developing a more ideal endometrial lining. This randomized study aims to     evaluate the impact of EA on endometrium undergoing medicated frozen embryo transfer cycle     preparation. The treatment group will receive four acupuncture treatments during the     medicated uterine preparation. Endometrial thickness will be compared to a group that does     not receive acupuncture.   "
137800|NCT01481077|"     The purpose of this study is to determine the effect of plug placement on the efficacy,     safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).   "
137801|NCT01481064|"     The purpose of this study is to evaluate the effects and costs of a multifaceted approach on     the patient-centredness of fertility care and the quality of life of fertility patients.   "
137802|NCT01481051|"     The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS     (latanoprost punctal plug delivery system) at different dose levels.   "
137803|NCT01481038|"     Up to date methods for diagnosis of Catheter Related Bloodstream Infections (CRBSI) are     performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from     CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis     or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. The     aim of the project is to investigate a more sensitive and specific test for anticipative     diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.   "
137804|NCT01481025|"     Climacteric Complains bring to women many problems for living a normal life - hot flashes,     irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new     horizon for this part of time.   "
137805|NCT01481012|"     The purpose of this study is to obtain data or information on how blood clotting factors are     activated during open heart surgery. In particular, the investigators are interested in how     blood clotting factors are activated by the heart-lung bypass machine and by left ventricular     assist devices (LVAD). Patients on these two machines have an increased risk of bleeding and     blood clot formation. This is because both machines stimulate the intrinsic coagulation     pathway, one of the chemical pathways that cause blood to clot. The process of surgery itself     also stimulates the extrinsic coagulation pathway, the other chemical pathway that causes     blood to clot. Stimulating these coagulation pathways can use up the body's clotting factors.     As a result, patients may be at risk for both bleeding and blood clot formation. The     investigators would like to study how the blood factors are activated during and after     surgery, to help develop treatments to prevent bleeding and clot formation.   "
137806|NCT01480999|"     The use of robotic surgery in the management of gynecologic cancers has increased     exponentially in the United States since the implementation of technology in 2005. In Canada,     access to the system is limited because of a lack of government funding. The government has     been reluctant to fund this technology because robust data, on the true impact to patient     care, is lacking.      This project will prospectively examine outcomes of women, with early stage endometrial     cancer, treated surgically. Open surgery will be compared to minimally invasive surgery (MIS)     which will include conventional laparoscopy and robotic surgery. The data collected will     include detailed assessment of surgical data, peri-operative events, quality of life     analysis, health economic evaluation and evaluation of MIS rates.   "
137807|NCT01480986|"     This is a prospective, single-armed, open label study on the efficacy and safety of     sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI     poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the     phase one step of the trial, receiving IP therpy. Once the IP therapy has been finished     without disease progression or progression occurs during the treatment, the patient will     enter the phase two step of the trial, receiving octreotide treatment. The primary endpoint     is progression free survival in the two steps respectively and secondary endpoint is disease     control rate, overall survival and safety   "
137808|NCT01480973|"     NSCLC is the leading cause of cancer mortality in North America, accounting for nearly 30% of     all cancer deaths. The standard treatment for patients with early-stage non-small-cell lung     cancer (NSCLC) is surgical resection of the involved lobe/lung. However, many patients are     unable to undergo such a major surgery due to medical illness, and an emerging     standard-of-care for these patients stereotactic-body radiation therapy (SBRT).      SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few     fractions (hypofractionation) to accurately describe, size-restricted malignant targets in     which motion has been accounted for during the delivery process. SBRT administration achieves     avoidance of normal tissue exposure to radiation during the planning process, by providing     for sharp fall-off dose gradients outside the target.   "
137809|NCT01480960|"     Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in     patients following lung transplantation. Exercise training has been shown to be a cornerstone     of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise     performance. In our study we will investigate the benefit of a whole body vibration training     in addition to a standard pulmonary rehabilitation program that includes endurance and     strength training. We will include a total of 140 patients (70 patients < 1 year after lung     Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that     an addtitional whole body vibration training produces a greater benefit to exercise capacity     in lung transplantat patients (LTx).   "
137810|NCT01480947|"     Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are     infected by rotavirus or salmonella.      Base on the past researches, there is benefit effect of probiotics on patients with diarrhea     or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three     independent probiotics, will be used in patients with acute diarrhea.      This is a single site, controlled clinical research. About 80 patients will be enrolled into     this study to evaluate the benefit effect of bio-Three among patients with acute enteritis     due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and     screened by inclusion and exclusion criteria and only eligible patients will be enrolled into     this study.   "
137811|NCT01480934|"     To compare the development of posterior capsule opacification (PCO) between eyes with and     without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic     intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not     increase the incidence of PCO at 4 years.   "
137812|NCT01480921|"     The objective of this study is to compare the effect of monitored, home-based exercise versus     hospital-based exercise on the quality of life of patients with congestive heart failure.     Secondary objectives are to assess the effect of the intervention on exercise capacity and     caregiver burden.      The investigators hypothesize that the exercise training in the home-based environment will     be superior to hospital based exercise training.   "
137813|NCT01480908|"     The most common congenital heart disease is the ventricular septal defect, and after surgical     closure of a such defect, an arrythmia called the right bundle branch block, is very     frequent. Therefore the aim of this study is to investigate if this group of patients has     inferior outcomes compared to the group without this arrythmia after surgical closure and     compared to a group of healthy control subjects.      All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography     during exercise, and 4. MRI. The perspective is the ability to point out a group of patients     with a possible need of further intervention, and additionally to increase the awareness of     protecting the electrical system of the heart during the operation.   "
137814|NCT01480895|"     Diabetes Mellitus (DM) is a chronic metabolic disorder with increasing incidence and long     term complications. Its incidence differs in various ethnic populations.Gestational DM (GDM)     is diagnosed when impaired glucose tolerance (IGT) is first detected during pregnancy. GDM     incidence in Jewish and Bedouin women has been rising in recent years. It has been reported     in many studies that women who had been diagnosed with GDM are more prone to GDM in their     next pregnancies and to DM Type 2.      Appropriate changes in everyday diet and physical exercise may reduce the chances for future     GDM and type 2 DM.      The investigators aim was to determine GDM frequency in the Negev area in Jewish and Bedouin     populations and to construct a plan for follow up and reduce future problems by changing     their life style.   "
137815|NCT01480882|"     A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine     which is supposed to mimic the chest percussion performed by professional physiotherapist to     mobilize sputum through the respiratory passage.      The aim of this study is to compare the effectiveness and safety of this mechanical     percussion device in the treatment of airway clearance with conventional chest physiotherapy     carried out by qualified physiotherapists in patients suffering from bronchiectasis or     Chronic obstructive Pulmonary disease (COPD).   "
137816|NCT01480869|"     The purpose of this study is to compare normalization of vitamin D serum level after 6 months     of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional     vitamin D supplementation.   "
137817|NCT01480856|"     Cobedding consists of associating twins in a common cocoon in order to maintain links     developed in utero and reduce the stress of premature birth. The aim of this randomized,     controlled prospective study is to compare efficacy (in term of newborn daily weight gain)     and safety of cobedding versus single-bedding of preterm twins.   "
137818|NCT01480843|"     The purpose of this study is to find out if simplifying your diabetes treatment by decreasing     number of insulin injections, with the help of a long acting insulin called glargine, can     decrease the episodes of low blood glucose.   "
137819|NCT01480830|"     Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In     Canada, up to 13% all colonoscopies do not examine the full colon and are therefore     incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to     twists and turns in the colon that make the colonoscopy difficult to perform and     uncomfortable for the patient.      This randomized study is being done to test a new colonoscopy system called the Scope Guide     that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the     patient's abdomen.      We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of     colonoscopy quality including rate of complete examination, patient comfort, polyp detection     rate, insertion time, amount of sedation required, and need for abdominal compression.   "
137820|NCT01480817|"     The investigators are going to compare the therapeutic effect of sorafenib and transarterial     chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein     invasion.   "
137821|NCT01480804|"     The purpose of this research study is to identify barriers affecting self care in older     patients with diabetes and to provide coping strategies for these barriers with help from a     care manager (Geriatric Life Specialist) to improve clinical, economical, functional and     psychosocial parameters.   "
137835|NCT01480622|"     This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF)     300 mg in Chinese subjects to support the registration of this compound in the People's     Republic of China. This will be an open-label, single group, single and repeat dose study     without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable     measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after     the single dose and at steady state. The duration of the study will be approximately 7 weeks     from screening to follow-up.   "
137836|NCT01480609|"     This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8     patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis.     Patients will remain in the unit during each treatment period from admission to the     collection of the final PK sample. The doses of ezogabine/retigabine in the two treatment     periods will be separated by at least 7 days.   "
137822|NCT01480791|"     This study will be performed only at the Jewish General Hospital. It will investigate the     effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the kidney     that constricts arteries and raises blood pressure, on the blood vessels, specifically the     arteries, of subjects who have diabetes and elevated blood pressure (hypertension).      To investigate blood vessels, different techniques will be used. For large arteries, these     will be studied by non invasive methods using detection of the pulse wave or using ultrasound     over the skin of the neck, the wrist and the groin. To study small vessels, the investigators     will perform a biopsy on the buttock, under local anesthesia, and obtain a small sample of     tissue from under the skin, from which the vessels will be dissected. The investigators have     performed many hundreds of these small biopsies over the past 20 years for similar studies     without any complications. The biopsies are very well tolerated. From this research the     investigators will thus be able to learn what the structure and function of these vessels is     in these patients, in comparison to a normal healthy group.      The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to     treatment with the renin inhibitor aliskiren or a comparator, the diuretic     hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is     very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic     individuals. The diuretic is a well-know agent used to treat high blood pressure now for many     years, and which is very well tolerated. Physicians, nurses and scientists involved in the     study will be unaware of who is receiving which drug, as will be the patients (this is the     meaning of double-blind trial). However, if there is any problem, the secret code will be     broken and the individual withdrawn from the study. Subjects will be treated for a year, and     the study procedures (non invasive and the biopsy) repeated at 6 months and after one year of     treatment. During the study, blood samples will be drawn and urine collected at certain     intervals to ensure safety of the treatment.      Once tissues are obtained they will be studied in the laboratory. The study of the vessels     will allow treatment us to determine how the treatment with the renin inhibitor aliskiren     affects the structure and function as well as cellular and molecular aspects of arteries of     hypertensive diabetic persons. The investigators expect these studies to provide us knowledge     on mechanisms and perhaps new targets for future therapies of cardiovascular disease and     hypertension.   "
137823|NCT01480778|"     Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química     Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical     Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by     measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation     demonstrated by transvaginal ultrasound examinations   "
137824|NCT01480765|"     The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery   "
137825|NCT01480752|"     To determine the effect of intraligamentary injection of Lornoxicam on the intensity of     post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.   "
137826|NCT01480739|"     Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and     function (phagocytosis and oxidative burst) in the circulation, following a burst of     strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating     factor (G-CSF)   "
137827|NCT01480726|"     Vena saphena magna is still frequently used as graft material in coronary artery bypass     grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh =     open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein     harvesting). The endoscopic techniques have been shown to reduce the incidence of     postoperative wound complications while patients are more satisfied with the cosmetic result     of the operation on the leg.      Non-randomized studies have raised doubts about patency rates of the vein grafts following     EVH compared to OVH, while other studies failed to detect any problems in relation to this.     There are only very few data on long-term patency rates from randomized studies.      The purpose of this study is to investigate clinical outcome and patency rates of the vein     grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as     part of a randomized study investigation wound complications. A cost-effectiveness analysis     will also be performed.      The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years     postoperatively.   "
137828|NCT01480713|"     This is a pilot, proof of concept, open-label clinical trial, to assess the extend of     persistent viral reservoir and the level of immune activation in patients receiving     suppressive treatment with protease inhibitors.      40 Chronically HIV-1 infected subjects, receiving monotherapy with ritonavir-boosted     lopinavir or darunavir for at least 12 months with plasma viremia below 50 copies HIV RNA per     ml, and CD4 T-cell counts greater than 500 cells/mm3 will be included.      The total duration of the study will be 48 weeks: 12 weeks for patients' inclusion, 24 weeks     of follow-up once the last patient is included, and 12 weeks for data analysis.   "
137829|NCT01480700|"     This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin     from lucerne protein concentrate and DHA from microalgae on the plasma levels of these     compounds but also on the macular pigment optical density, whose elevation may be beneficial     in the prevention of Age-related Macular Degeneration (AMD).   "
137830|NCT01480687|"     The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty     acid supplementation on the vascular structure and function in hypertensive patients with     hypertriglyceridemia.   "
137831|NCT01480674|"     This observational study will characterize retrospectively patients with HER2-positive     metastatic or locally advanced breast cancer who had received treatment with Herceptin     (trastuzumab) in 1st line and who were without progression for at least three years. Patients     will be followed prospectively for one year.   "
137832|NCT01480661|"     In this study the possible changes in airway geometry and function induced by 6 month oral     treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory     imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients     will be examined. The study population consists of 40 severe COPD patients, global initiative     for chronic obstructive lung disease (GOLD) stages III until IV.      Imaging parameters will be assessed and the correlation with lung function and health related     quality of life will be checked before and after treatment.   "
137833|NCT01480648|"     This first-in-man trial forms the basis for potential clinical development of BI 144807 in     the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics,     and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male     volunteers.   "
137834|NCT01480635|"     Purpose of study:      To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard     colonoscopy      Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects      Subject population: Patients that are indicated for colonoscopy, who are suspected or known     to suffer from colonic diseases and had an incomplete standard colonoscopy      Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One     week follow up Duration of study: 12 months      Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon     segment not reached by an incomplete standard colonoscopy Evaluation of distribution of     excretion of capsules over time   "
137837|NCT01480596|"     Study BEL115123 is a randomized, placebo-controlled, double-blind, multinational study of     belimumab (10 mg/kg) to investigate the efficacy and safety of belimumab in subjects with MG.     The study will enroll male and female outpatients (> or equal to 18 years of age) with a     diagnosis of MG who are 1) acetylcholine receptor (AChR) antibody positive or muscle specific     kinase (MuSK) antibody positive, 2) on current standard of care therapy, and 3) continue to     exhibit signs of MG. The study will include 3 phases: a 4 week screening period, a 24 week     treatment period, and a 12 week follow-up period. IP will be administered intravenously on     Days 0, 14, 28 and then every 28 days through and including Week 20. At Week 24, primary     outcomes will be obtained. Follow up evaluations will be conducted at Weeks 28, 32 and 36 for     all subjects. The primary objective of this study is to assess the efficacy of belimumab as     evaluated by the change in the quantitative myasthenia gravis (QMG) score.   "
137838|NCT01480583|"     The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in     patients with brain metastases from breast cancer. For patients with HER2 positive metastatic     breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per     standard-of-care practice.      In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of     change in the uptake in the brain metastases from breast cancer after GRN1005 treatment,     correlates with intra-cranial response (for patients enrolled at NCI).   "
137839|NCT01480557|"     Objective of this study is the comparative assessment of the impact of torsional and     liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal     sensitivity (CCS) in a sample of cataract patients.      Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible     basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear     opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale     [10]. By means of a custom computer randomization program all participants randomly populated     two study groups according to the cataract-extraction technology used: a) Torsional group     (TG) and b) Liquefaction group (LG).   "
137840|NCT01480544|"     The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi Bhagya     Yojana) to promote child birth in obstetric facilities in the state of Karnataka, India in     order to determine its policy value and to guide efforts to improve maternal and infant     health outcomes nationally. In addition, the study includes a large randomized evaluation of     performance-based incentive payments to providers to improve quality of medical care provided     during delivery and actual health improvement in the providers' patient populations and their     catchment areas.   "
137841|NCT01480531|"     2. Purpose of the Study -        1. To determine the feasibility of Clevidipine use for rapidly achieving and maintaining          individually specified patient BP target ranges in the pre and postoperative periods of          aortic aneurysm and dissection management.        2. To determine the safety of Clevidipine use in the pre and postoperative periods of          aneurysm and dissection management        3. Background & Significance - Surgical treatments for persons with aortic root/arch          dissection or aneurysm have significantly improved survival. However, critical in          management of these patients is precise control of blood pressure (BP). With increasing          BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is          imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal          cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the          target systolic blood pressure range for these patients is 100-120 mmHg.           Several different classes of vasoactive agents are in current use to acutely manage BP          but none possess the optimal profile of an ideal vasodilator. Notable limitations          include inadequate potency, slow onset and offset of action, multiple receptor function,          safety concerns and, importantly, restricted/ineffective titration, which results in          clinically significant hemodynamic and cardiovascular perturbations.           Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker          clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in          critical care settings.           Clevidipine's pharmacology lends itself to acute management of BP in a broad critical          care setting in both surgical and nonsurgical patients. In the current study, the          investigators propose to further characterize the hemodynamic effect of CLV in the pre          and post-operative management of BP in patients with aortic aneurysm/dissection.        4. Design & Procedures Eligible patients will be approached to participate in the study by          the Intensive Care Unit (ICU) attending and/or by a cardiothoracic          surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical          management and monitoring will be according to standard practice that includes:             -  ECG             -  Oxymetry             -  Temperature             -  Invasive arterial blood pressure             -  Recording of routine laboratory results             -  Imaging studies including CT/MRI (A)/ Echocardiography             -  Pulmonary artery catheter (postoperative patients)             -  Mechanical ventilation (postoperative patients)             -  According to established protocol for acute intravenous management of arterial               blood pressure in these patients, an upper and lower threshold of systolic blood               pressure will be prescribed by the attending physician (the range being (100 mmHg               -120 mm Hg SBP).      Hemodynamic data will be collected continuously via a bedside laptop as well as pertinent     clinical data and information about efficacy and safety will be recorded.      • Subjective evaluation of efficacy of CLV (questionnaire format to be completed by the     critical care team)   "
137842|NCT01480518|"     RATIONALE: Studying samples of tissue in the laboratory may help doctors learn more about     changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors     understand how well patients respond to treatment.      PURPOSE: This research study is studying biomarkers in tissue samples from patients with     Ewing sarcoma.   "
137843|NCT01480505|"     Purpose:      To assess the functional and anatomical outcome of primary vitrectomy without scleral     buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length     over 30 mm.      Methods Design: Retrospective single center series. Setting: University Hospital. Patients:     High myopic patients treated with primary vitrectomy without scleral buckling for a     rhegmatogenous retinal detachment.      Outcome measures: Anatomical success rate with complete reattachment of the retina without     silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).   "
137844|NCT01480492|"     During hepatitis B virus(HBV) infection host immune plays important role.Recently there are     many different antiviral therapy methods.Different antiviral therapy methods showed different     effector.In order to investigate whether these antiviral therapy methods especially methods     directly inhibit viral replication have some effect on host immune the investigators designed     these study. The investigators want to observe the change of host immune during antiviral     therapy in patients with chronic HBV infection, and analyze the relationship between these     changes and the antiviral effector of these drugs.   "
137845|NCT01480479|"     This 2-arm, randomized, phase III study will investigate the efficacy and safety of the     addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer     effects in patients who have tumors that express the EGFRvIII protein) to the current     standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of     brain cancer.      All patients will be administered temozolomide, the standard treatment for glioblastoma. Half     the patients will be randomly assigned to receive rindopepimut and half the patients will be     randomly assigned to receive a control called keyhole limpet hemocyanin.      Patients will be treated in a blinded fashion (neither the patient or the doctor will know     which arm of the study the patient is on). Patients will be treated until disease progression     or intolerance to therapy and all patients will be followed for survival.   "
137846|NCT01480466|"     Overweight and obesity are highly significant clinical and public health issues, affecting     more than two-thirds of adults in this country; however, primary care clinicians often do not     document overweight or obesity or discuss weight management with their patients. The     objectives of the proposed research are to develop and evaluate a set of tools within     electronic health records (EHRs) to assist primary care clinicians with the diagnosis and     treatment of overweight and obesity and to help patients manage their weight.   "
137847|NCT01480453|"     The objectives of this study are to obtain survival and outcome data on the Trabecular Metal     Humeral Stem when used in primary, total or hemi shoulder arthroplasty.   "
137848|NCT01480440|"     The objectives of this study are to obtain survival and outcome data on the Trabecular Metal     Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.   "
137849|NCT01480427|"     The purpose of this study is        1. To validate in french quality of life questionnaires for food allergic children        2. To evaluate if the quality of life of food allergic french speaking children aged 0-12          years is affected by their condition        3. To validate a didactic game for food allergic children   "
137862|NCT01480258|"     This study will determine whether subjects who receive V419 at 2, 4, and 11 to 12 months of     age have an acceptable response to the vaccine. this study will also determine whether the     immune response to V419 is similar to that of subjects who received a licensed vaccine     control.   "
137850|NCT01480414|"     Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb     perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic     needs of the tissue, even under resting conditions. The limits of peripheral artery disease     (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have     been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults     older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of     collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the     pathophysiology of vascular disease. By stimulating these processes the investigators might     be able to provide an alternative treatment strategy for patients with lower limb ischemia.     In response to tissue injury and remodeling, neovascularization usually occurs via the     proliferation and migration of progenitor endothelial cells (EPC) from preexisting     vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC)     implantation increases collateral vessel formation in patients with limb ischemia. So the     investigators determine to evaluate the efficacy of repeated MNC transplantation in patients     with ischemic lower limb.   "
137851|NCT01480401|"     This study aims to identify the relationship between a low-sodium diet and neurohormonal and     clinical status in stable chronic HF patients.   "
137852|NCT01480388|"     The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979     at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in     patients with active rheumatoid arthritis despite concomitant treatment with methotrexate     (MTX).   "
137853|NCT01480375|"     Prostate biopsy is a procedure in which small samples are removed from a man's prostate gland     to be later tested for the presence of cancer. It is typically performed when the scores from     a PSA blood test rise to a level that is associated with the possible presence of prostate     cancer.      The most common method for performing a prostate biopsy procedure is the ultrasound guided     transrectal procedure. The information obtained from the standard prostate biopsy is     deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy.     Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It     was proven that the exact location of the obtained cores, even in an initial biopsy, can     influence the cancer detection rate2.      An imaging tool that will enable a three-dimensional navigation in the prostate volume and     selecting biopsy locations in view of previous core taken will allow building a tumor map     '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate     treatment can be chosen while avoiding over or insufficient treatment.      However, to be able to produce an accurate mapping of the malignant tissue, a complementary     optimized pathology method should be also implement in addition to the navigation system, it     has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding,     unity, and location along the needle notch improves the histological yield and hence the     cancer detection rate3.      The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows     physicians to see the prostate gland together with the biopsy sites in a three dimensional     (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as     an adjunct to standard of care procedures, to work with standard rectal ultrasound probes,     and to be incorporated side by side with the techniques currently employed. No change to the     current employed procedures and techniques is required or suggested. In complementary to the     Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the     orientation, unfolding and unity of the sample was developed to increase the pathology     utility.      The study objective is to evaluate the contribution of the Navigo™ system, an aiding     navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection     ability.   "
137854|NCT01480362|"     On behalf of a consortium of 19 health insurance companies the Institute for Research in     Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and     conducting a clinical study evaluating the efficacy and effectiveness of negative pressure     wound therapy in the treatment of wound healing disorders of the foot, which are caused by     diabetes mellitus.      This german multicenter study is due to evaluate whether the negative pressure wound therapy     or the control therapy (standard wound therapy following the guidelines) is superior.      Patients will be randomly assigned to the two study arms. Both patients and the treatment     staff know about the specific allocation to the negative pressure wound therapy or standard     wound therapy arm.      A photo documentation and a computer-based evaluation of the wound images will be performed.     This is done centrally by independent examiners, who don`t know neither the patient nor the     treatment assignment.      It is believed that the application of the negative pressure wound therapy systems compared     to standard therapy of diabetic foot wounds will lead more frequent and more rapid to the     achievement of complete wound closure and that the use of negative pressure wound therapy is     an effective and safe therapy option for the treatment of diabetic foot wounds in inpatient     and outpatient care.      Patient´s to be included into the study should have either a chronic diabetic foot wound     existing longer than 4 weeks whereas dead tissue components must be completely removed by the     doctor or a wound after amputation of foot parts.      The study treatment may have already started in the hospital if applicable. The further wound     treatment will be mainly performed within outpatient care. Study Participants will return to     the study centre for regular study visits or even for wound treatment.      The comparison of the outcomes of both study arms will give valuable information about the     efficacy of negative pressure wound therapy in inpatient as well as outpatient care. These     results should be provided until the end of 2016 as a basis for the decision of the Federal     Joint Committee to answer the question if the negative pressure wound therapy can be approved     as a standard service for reimbursement by health insurance companies.   "
137855|NCT01480349|"     This multicenter, prospective pilot study will compare the effectiveness of two established     procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight     infants, specifically ventricular reservoirs and subgaleal shunts. The study is being     conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to     conduct multi-institutional clinical trials on pediatric hydrocephalus.   "
137856|NCT01480336|"     The purpose of this study is to learn if combination therapy with amiodarone and ranolazine     (an approved drug for chest pain) can help prevent arrhythmias.   "
137857|NCT01480323|"     The current clinical trial shall clarify a synergistic effect with regards to efficiency by     the combination of intratumoral injection of interleukin-2 (IL-2) and the intra-venous     application of ipilimumab.   "
137858|NCT01480310|"     This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD)     study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study     site in Canada.   "
137859|NCT01480297|"     This 12 week study will examine the effects of daily Salsalate treatment on markers of     neuropathic pain and intra-epidermal nerve fiber density. the study is being done in people     with type 1 diabetes with signs and symptoms of peripheral neuropathy.   "
137860|NCT01480284|"     The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered     once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis     B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to     ETV will be verified using the antiviral effect as the index.   "
137861|NCT01480271|"     GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially     inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα).     The aim of this FTIH study is to collect tolerability, pharmacokinetic (PK) and     pharmacodynamic (PD) information to enable the identification of appropriate safe doses of     intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes in the     nasal milieu, for use in subsequent clinical drug development studies. There will be two     parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part 1,     followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.   "
137866|NCT01480206|"     As endovascular procedures become more complex, there is a growing need for 3D image overlay     to assist with device guidance and placement. Currently, a 3D image is typically created     intra-operatively using 3D rotational angiography (3D-RA) or cone-beam CT (XperCT). This 3D     image may then be overlaid on live fluoroscopy to provide 3D guidance information (Dynamic 3D     Roadmapping). Philips Healthcare multimodality overlay products allows registration of a     pre-acquired MR/CT or 3D rotational image to live fluoroscopy.   "
137867|NCT01480193|"     Tinnitus is a common problem for which there is no universally effective treatment. The best     available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but     only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only     formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of     tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans received     a disability award for their tinnitus amounting to a total annual compensation amount of over     $345.5 million. Individuals with persistent severe tinnitus are unable to habituate to the     tinnitus sound that most likely originates in the central auditory system (CAS) in response     to peripheral injury. In a widely referenced study, it has been hypothesized that lack of     habituation is secondary to abnormal processing of sensory information. Specifically,     processing by the limbic system and autonomic nervous system is apparently abnormal in     patients with increased levels of cortical arousal and inadequate coping mechanisms. In     otolaryngology and audiology clinics, 'sound-based and educational therapies' (SBE) are the     focus of most current therapies, and utilize enhanced sound input to the CAS. While SBE     treatments may well provide a starting point for tinnitus treatment, additional treatment     options are necessary particularly for those with significant non-auditory aspects of     tinnitus (e.g., anxiety, depression, interference with daily life) as well as for those who     do not experience significant improvement with SBE. Furthermore, commonly used forms of SBE     [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year to become effective and may     not be used in patients with hearing that is too poor to be modified by sound input. Based on     prevalence data from tinnitus sufferers who seek treatment and the known percentage who do     not respond to commonly used therapies, we estimate that 1.2 million individuals are not able     to benefit at all from current, widely used treatment strategies. A new strategy to augment     those currently used could empower patients to exert control over their tinnitus symptoms     without the use of medications, expensive devices such as the Neuromonics device, or extended     programs such as TRT. An alternative strategy may be useful both for patients who are not     candidates for SBE and for those who respond poorly. An Integrative Medicine approach     provides a likely solution. To date, there has been no systematic study of the benefits of an     Integrative Medicine approach for severe tinnitus, particularly for non-auditory aspects of     tinnitus symptoms. The goal of the proposed study is to determine if an integrative medicine     approach which targets treatment of the nonauditory aspects of tinnitus suffering is more     effective in alleviating tinnitus symptoms when added to current commonly applied SBE     therapies, compared with SBE alone. If successful, this approach will be applied to a larger     patient population in future studies to test the generalizability and the durability of the     effect. Our eventual goal is to develop a streamlined approach that individualizes tinnitus     treatment based on symptoms and patient characteristics, and that can be widely applied in     general medical practice.   "
137868|NCT01480180|"     This trial is conducted globally. The aim of the trial is to evaluate the safety and     efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC     0129-0000-1003 (N8-GP) in subjects with Haemophilia A.   "
137869|NCT01480167|"     The objective of this post market clinical investigation is to evaluate the clinical     effectiveness of a minimally invasive vertebral augmentation procedure,     Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to non-operative     management (NOM) for the treatment of appropriately diagnosed acute (≤ 8 weeks) painful     osteoporotic vertebral compression fractures (VCF).   "
137870|NCT01480154|"     This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206     together with hydroxychloroquine in treating patients with advanced solid tumors, melanoma,     prostate or kidney cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving     Akt inhibitor MK2206 together with hydroxychloroquine may kill more tumor cells.   "
137871|NCT01480141|"     This study is for patients that have Non-Small Cell Lung Cancer (NSCLC) and he or she will     have surgery to remove the tumor. The main purpose of this study is to study how safe and     suitable treatment with Afatinib is in participants before surgery to remove the tumor.     Another goal of the study is to see if treatment with Afatinib affects the growth and     activity of the tumor. Afatinib has not been approved for use by the FDA (Food and Drug     Administration) and is experimental.      In some persons, the growth of cancer cells is thought to be stimulated by Epidermal Growth     Factor (EGF). This is a protein found in the body which binds to the cell wall to sites     called receptors and stimulates cell growth. Some cells have too many receptors and     uncontrolled growth and because of this, develop into a cancer tumor. There are several other     cancer drugs that bind to these receptors to slow or stop cancer growth such as Gefitinib and     erlotinib which are FDA approved and used for the treatment of NSCLC.      The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may     be a candidate for the treatment of NSCLC and a variety of early stage cancers. Participants     in this study will take Afatinib by mouth, in pill form, for at least 14 days before having     their scheduled surgery to remove their cancer tumor. Participants will be observed for side     effects and followed for 30 days after surgery to assess the results after surgery.   "
137872|NCT01480128|"     This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy     for colon cancer treatment, in terms of safety, efficacy, and cost.      The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to     multiport laparoscopic colectomy.   "
137873|NCT01480115|"     The ultrasound unit in Meir Medical Center developed new software to automated ovarian     follicle count on the basis of 3D US. The investigators intent to evaluate this software at     two steps:        -  To compared the abilities of the software to physician follicle count.        -  To evaluate with the software the antral follicle count, as expression to ovarian          reserve at 3 different time of the month.      The investigators believe that the software measurement of the small follicle can be better     than the common antral follicle count that is use today, and by this accurate evaluation of     the small follicle the investigators can evaluate the ovarian reserve at any time of the     mount, and not only at the early follicular phase that use today.   "
137874|NCT01480102|"     This study will compare post-operative pain levels in patients who receive paravertebral     block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive     the block. We hypothesize that patients who receive the block will have lower post-operative     pain scores and require less narcotics.   "
137875|NCT01480089|"     The purpose of this trial is to determine the effect of spraying a local anesthetic called     Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a     local anesthetic used to block pain in the body. There are studies showing that Ropivacaine     decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder     removal but has not been tried in robotic pelvic surgery.   "
137876|NCT01480076|"     The primary objective of the study is to assess the effect of long-term treatment with     prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale     (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment     responders. The secondary objectives of this study are to compare the change in the PCS of     the SF-36 between treatment responders and non-responders, to evaluate change from baseline     in additional quality of life measures among treatment responders as well as changes from     baseline in treatment responders versus non-responders and to assess the safety and     tolerability of prolonged-release fampridine 10 mg twice daily.   "
137877|NCT01480063|"     The primary objective of the study is to collect additional safety data including the     incidence rate of seizure and other specific Adverse Events (AEs) of interest from     participants taking Fampyra in routine clinical practice. The secondary objectives of this     study are to characterize utilization patterns of Fampyra in routine clinical practice, to     assess the effectiveness of risk minimization measures as described in the risk management     plan for Fampyra, to assess the change over time in participant self-reported evaluation of     the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to     assess the change over time in physician assessment of walking ability in participants taking     Fampyra (MS participants only).   "
137878|NCT01480050|"     RATIONALE: Mibefradil dihydrochloride may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in     different ways to stop the growth of tumor cells, either by killing the cells or by stopping     them from dividing.      PURPOSE: This phase I trial is studying the best dose of mibefradil dihydrochloride when     given together with temozolomide in treating patients with glioma.   "
137879|NCT01480037|"     The present study proposes the characterization of sleep patterns of healthy young adults,     elderly individuals and individuals above 85 years old, using polysomnographic recordings, in     order to clarify the importance of sleep in longevity. Furthermore, this study intends to     analyze the oxidative stress-related gene expression in peripheral blood of the three studied     groups, using the Superarray - RT2 Profiler PCR Array System. After the identification of     genes whose expression pattern among groups suggest a more specific role in longevity, the     mechanisms of gene expression regulation, including DNA methylation patterns and microRNA     expression, as well as the possible genomic sources of variation in these genes will be     investigated. In addition, the oldest individual (105 years-old) will have his whole genome     sequenced using next-generation sequencing technology, in order to identify rare variants     associated with longevity. Subsequently, the effect of the polymorphisms and rare variants     identified will be confirmed in an expanded sample constituted of individuals with various     age-ranges. The study will provide a better characterization of molecular and physiological     mechanisms involved in longevity, hoping to contribute to the development of more advanced     clinical tools, capable to offer a better quality of life for the elderly.   "
137880|NCT01480024|"     The investigators will test the hypothesis that obese women have a unique oocyte gene     expression profile that differs significantly from that of normal weight women.   "
137881|NCT01480011|"     Patients with various malignancies who are taken up for high dose chemotherapy followed by     stem cell transplant (blood and marrow transplant) have very high chances of developing     severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity     but also hampers quality of life so much so that patients at times feel difficult to continue     treatment.      No definite treatment exists for prevention or treatment of oral mucositis in this group of     patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth     factor) will reduce duration and severity. Palifermin is very expensive and not available in     country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD     2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck     squamous cell cancer patients. (Published online in European Journal of Cancer:     http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported with     its use.      Now, the investigators want to study the efficacy of this drug to reduce severity of     mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be     supplied by CD Pharma India Private Limited.      The investigators further give undertaking that study will be carried as per good clinical     practices (GCP) and declaration of Helsinki.   "
137882|NCT01479998|"     Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling     sessions and nicotine replacement therapy (NRT)) or 2) standard care + contingency management     (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers)   "
137883|NCT01479985|"     The purpose of this study is to conduct a randomized clinical trial of a web-based     contraceptive decision aid compared to routine contraceptive counseling to evaluate the     effect of the contraceptive decision aid on the contraceptive method selected by the     participant.      The investigators primary hypothesis is that women utilizing a computerized Contraceptive     Decision Aid (CDA) will be more likely to choose highly effective contraception than women     who undergo standard clinical contraceptive counseling.   "
137884|NCT01479972|"     Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing     BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against     tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas.     The new vaccine should be at least as potent as the current strain and should be safer than     BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised     bacteria to be re-suspended before intradermal injection. The preceding clinical trials in 80     volunteers in Germany and 24 volunteers in Bloemfontein, South Africa indicated     immunogenicity and safety being sufficient for proceeding with the clinical development in     newborn infants. Hence, the current study is commenced at Stellenbosch University, South     Africa. This is the first investigation of VPM1002 in newborn infants.   "
137885|NCT01479959|"     Adequate communication is a major part of the quality of life of tracheostomized ventilator     dependent patients. Maintaining speech is therefore major goal in the management of these     patients.      The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the     improvement of speech. The best level for speech may vary from one patient to the other The     purpose of this study is to determine individually the most efficient PEEP level in terms of     speech while obtaining the most secure condition and the best possible respiratory tolerance.     In order to improve the latter, the investigators will use a device which allows the patients     to control the activation of PEEP so that they can use it only when needed (i.e. when they     wish to speak). The investigators will compare the effect of different PEEP level to try to     determine the best compromise to improve speech in tracheostomized ventilator-dependent     patients.   "
137886|NCT01479946|"     Electroporation combined with chemotherapy (ECT) has been shown to be an effective treatment     for breast cancer that has spread to skin. In routine clinical practise, ECT is offered to     patients when all other treatment options have been exhausted. This study tests the     hypothesis that early treatment with ECT may result in improved local control of skin     metastases, improved quality of life and reduced health care costs. Patients are randomised     to either ECT given as early as possible in the course of the disease or delaying ECT for at     least 6 months.   "
137911|NCT01479621|"     This is a randomized, double-blind, placebo- and open-label active controlled,     parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and     older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary     objective of this study is to evaluate the dose response, efficacy and safety of 4 different     doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler)     when administered twice daily.   "
137937|NCT01479270|"     The Transversus Abdominal Plane (TAP) block has been used with good success to decrease     postoperative pain following laparatomy. If the TAP block provides any improvement in the     quality of recovery following laparoscopic hysterectomy, it could decrease the need for     postoperative narcotics and allow for more outpatient hysterectomy procedures.   "
137887|NCT01479933|"     Vitamin D deficiency is widespread throughout the world, and the deficiency has been     associated with several chronic diseases, such as cardiovascular diseases and diabetes. In     Nordic countries, like in Finland, there is a particular variation in vitamin D status, and     during wintertime, when there is no exposure to ultraviolet-B light from the sun, serum     concentrations of vitamin D decrease substantially. In Finland, some 40% of middle-aged men     and one third of women also have some degree of impairment of glucose metabolism.      The purpose of this trial is to investigate the effects of two different daily doses of     vitamin D on glucose metabolism in men 60 years of age or older and who are vitamin D     deficient, have a high body mass index and at least two characteristics of cardio-metabolic     syndrome.      Altogether 102 subjects with low serum calcidiol (<60 nmol/L) will be recruited and     randomized to one of the three groups: 1) 40 µg/d vitamin D3, 2) 80 µg/d vitamin D3 or 3)     placebo. The supplementation period will last for 6 months from September 2011 to March 2012.      The main hypotheses of the trial are: (1.) Vitamin D supplementation will improve glucose and     insulin metabolism in people with a low baseline vitamin D status, in a dose-dependent     manner. (2.) Vitamin D supplementation will have an effect on the expression of genes     involved in glucose and insulin metabolism and inflammation. (3.) Vitamin D supplementation     will have an effect on epigenetic changes in key genes participating in vitamin D metabolism.   "
137888|NCT01479920|"     This is a randomized, assessor-blind, placebo controlled study in major depressive disorder     (MDD) patients. Subjects receiving antidepressant drug (FLX) would be assigned to receive     either 18 sham / active DCEAS for in 6 weeks. Changes in the severity of depressive symptoms     over time are measured using depression rating scales. Brain glucose metabolic levels are     measured using PET at baseline and endpoint. The most intriguing and expected result might be     that acupuncture treated-patients may display comparable or even better outcomes and the     clinical improvements by acupuncture are correlated with the restoration of the activities in     the related brain regions.   "
137889|NCT01479907|"     The aim of this double-blinded prospective randomised trial is to explore the potential     benefits of early postoperative administration of Synbiotics (combination of prebiotics and     probiotics) to patients who have undergone colectomy for cancer. The patients are randomised     to either synbiotics or placebo administration at the day they are able to tolerate po liquid     diet and for 15 days thereafter.      Primary end points of the study will be:      Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months     postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of     Life Index)      Secondary end points will be:      -Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months     postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30   "
137890|NCT01479894|"     This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the     distribution of Recurrence Score® and gene groups of stage II colon cancer in African     American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be     analyzed as well. Three institutions will contribute patients to this study with a total     patient number goal of approximately 200 with approximately 100 being AA and approximately     100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched     for every African American enrolled.   "
137891|NCT01479881|"     The purpose of this study is to investigate the effect of steady-state concentrations of     TMC435 (administered once a day) on the single-dose pharmacokinetics of the     immunosuppressants cyclosporine and tacrolimus in healthy participants. Cyclosporine and     tacrolimus are immunosuppressants used to prevent transplant rejection and may therefore     potentially be coadministered with TMC435 in patients infected with hepatitis C virus that     undergo liver transplantation. We will also explore the short-term safety and tolerability     following coadministration of TMC435 at steady-state and (1) cyclosporine or (2) tacrolimus     after single dosing in healthy participants. Steady-state is a term that means that the drug     has been given long enough so that the plasma concentrations will remain the same with each     subsequent dose. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream,     distributed in the body and eliminated from the body.   "
137892|NCT01479868|"     The purpose of this study is to evaluate the safety and tolerability of TMC435 along with     pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C     virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and     to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after     the planned end of treatment.   "
137893|NCT01479855|"     The purpose of the study is to compare the concentrations of Vitamin B1 (thiamine), Vitamin     B6 (pyridoxal-5-phosphate), folate, Vitamin B12 (cobalamin), Vitamin C (ascorbic acid),     Vitamin A (retinol), Vitamin E (alfa-tocopherol), homocystein, uric acid, F2 8-α-isoprostane,     8-deoxyguanosine, retinoids, tau-protein and β-amyloid in spinal fluid, metabolomics,     proteomics, m-RNA for DNA repair enzymes and DNA in patients who suffer from mild cognitive     impairment (MCI) or mild dementia of Alzheimers type, with healthy controls.      A second aim is to explore the association between vitamin and nutrient reductions, if any,     and cognitive function as well as vascular score and possible changes in the MRI.   "
137894|NCT01479842|"     This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when     given together with rituximab and bendamustine hydrochloride in treating patients with     recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as     rituximab, can block cancer growth in different ways. Some block the ability of cancer to     grow and spread. Others find cancer cells and help kill them or carry cancer-killing     substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in     different ways to stop the growth of cancer cells, either by killing the cells or by stopping     them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine     hydrochloride may kill more cancer cells.   "
137895|NCT01479829|"     This project will attempt to enhance and augment the antidepressant efficacy of a commonly     used antidepressant in poorly responding bipolar depressed patients.   "
137896|NCT01479816|"     This study will analyse existing data to establish a clinically useful index to predict those     women who are more likely to become incontinent. This would create significant opportunities     for focused prevention and early intervention strategies.   "
137897|NCT01479803|"     The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for     the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22     gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). In     case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is     severe and extensive treatment, remains important. To improve the sensitivity of EUS echo     endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE     Mark in the field of EUS. This instrument combines the comfortable and handy size of 22 Gauge     and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy.     In addition, a single pass through the tumor is achieved with this hand against several (2-3     minimum) with the current hardware. The theoretical goal is to have a tissue material more     abundant during the sampling, without increasing morbidity and increase the diagnostic     accuracy. A preliminary prospective study with this material has shown interesting results     (increase the diagnostic accuracy of 15%).      To determine the diagnostic gain with this new hand, it seemed essential to propose a     prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge)     randomized (randomization of the order of the needles) in crossover (on the same lesion) in     samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for     punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles     on the same injury can limit the effect of variability between patients and thereby have a     better power for the investigators study without increasing the risk of complications (the     needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic     solid tumors is one that poses the biggest diagnostic problem still present in the     investigators daily practice. The aim of this study is to compare the diagnostic accuracy of     the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for     pancreatic solid tumors under EUS.   "
137898|NCT01479790|"     Dry eye is a common condition that affects vision and quality of life in patients. Dry eye     clinical research is limited to follow up of disease progression. Currently, most research     outcomes are based on subjective patient complaints rather than objective assessment of the     condition. Only few objective measurements for dry eye are available today and this is mainly     the result of poor repeatability and inaccuracy.      This current study aims to evaluate 2 new non-invasive imaging techniques suitable for dry     eye assessment.      Anterior segment optical coherence tomography (AS-OCT) is an imaging device that has the     ability to image the tear meniscus of the eye in a safe and non-invasive manner. Image     analysis can then indirectly determine the tear film volume. Improvements in the image     resolution of these devices require a study that compares the repeatability and agreement of     an older (Visante AS-OCT) and a newer instrument (Cirrus AS-OCT) which the current study aims     to address.      Another method of evaluating dry eye disease is a novel technique that uses functional     infrared thermography to measure tear evaporation rate. This study will also establish     repeatability of measurements of the ocular surface temperature which are used to calculate     tear evaporation rates.      Should these methods are found to be repeatable, they can be used in future clinical trials     as an additional tool to investigate dry eye treatments.   "
137899|NCT01479777|"     The research is being done to find out if Functional Electrical Stimulation (FES) stepping     can improve the function of people with spinal cord injury that paralyzes.   "
137900|NCT01479764|"     This study will compare the incidence of residual neuromuscular blockade in participants who     undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo     reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).   "
137901|NCT01479751|"     In this study, methods which are known for facilitating rapid sequence intubation or     accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine     pretreatment, large dose rocuronium and priming.   "
137902|NCT01479738|"     The capitate had a widened distal base. The distal articulation can be used for proximal     interphalangeal (PIP) articula reconstruction.   "
137903|NCT01479725|"     To review the results of Hyperbaric Oxygen therapy (HBOT) on the symptoms of interstitial     cystitis (IC). To determine if there is greater symptom improvement in the ulcerative vs the     non-ulcerative patients with interstitial cystitis.   "
137904|NCT01479712|"     The purpose of this study is to determine if intra-abdominal irrigation at the time of     cesarean delivery increased maternal GI discomfort without affecting infection rates.      We hypothesized that avoiding intra-operative irrigation at the time of cesarean delivery     will decrease intra-operative nausea and vomiting without increasing maternal infectious     morbidity, post-operative pain, return of bowel function, or time to discharge.   "
137905|NCT01479699|"     The purpose of this study is to determine how olive leaf is absorbed and metabolised and also     whether it has any effect on the elasticity of blood vessels and the immune system.   "
137906|NCT01479686|"     Many clinical studies have been reported on iMRI, however, their evidence levels are     relatively not as good as what people hope they will be. Based on the available literature,     there is, at best, level 2 evidence that iMRI-guided surgery is more effective than     conventional neuronavigation-guided surgery.      The investigators aim to do a single center prospective randomized triple-blind controlled     clinical trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma     resection on surgical efficiency and progression-free survival of malignant glioma to provide     a level 2A evidence for its clinical application.   "
137907|NCT01479673|"     The aim of this study is to perform a prospective, randomized, controlled blinded study in     critically patients to assess the necessity for measuring daily resting energy expenditure as     a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the     rate of new infections.      Study Design :Multi-center, randomized, single blinded, controlled study. Study Population:     newly-admitted, adult mechanically ventilated ICU patients.   "
137908|NCT01479660|"     Intestinal inflammation seen in inflammatory bowel disease (IBD) results from an altered     mucosal immune response to luminal bacterial antigens. Current research suggests that an     inappropriate and persistent immune response against commensal intestinal bacterial flora     plays a pivotal role in the pathogenesis of chronic Inflammatory Bowel Disease (IBD). It has     been also proposed that the signs and symptoms of IBD may be mediated by the increased     intestinal permeability secondary to low grade inflammation in the gut mucosa. Increased     intestinal permeability results in further exposure of underlying intestinal mucosa to     luminal bacteria and antigens perpetuating the intestinal inflammation. Thus restoring     intestinal permeability rather than only reduction of mucosal inflammation would thus be a     desirable endpoint in the restoration of mucosal integrity and would be the harbinger of     better long term outcome. Many clinical trials have shown that probiotics may have beneficial     effect on IBD patients. Probiotics are hypothesized to work by several mechanisms though they     are not clearly established. The role of probiotics in improving intestinal permeability has     not been evaluated. The probiotic VSL #3 is easily available, cheap, effective and safe     alternative or substitute for the existing therapeutic agents will be evaluated in this study     for their efficacy, tolerability, compliance in inducing clinical response in patients with     Ulcerative colitis. This will be a double blind randomized placebo controlled study to     determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3) in patients with     inflammatory bowel disease. The objectives of this study are to determine the efficacy of     probiotics on clinical endoscopic and histological improvement, to find the improvement in     faecal, serum and intestinal tissue inflammatory markers, improvement in intestinal     permeability, improvement in Quality of life parameters.   "
137912|NCT01479608|"     Colorectal liver metastases (CLM) are currently considered an absolute contraindication for     liver transplantation (Lt) although Lt for other primary and secondary liver malignancies     show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed,     but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then,     several advances have been achieved and survival following Lt has improved by almost 30%.     Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.      The investigators have previously included 21 patients in a pilot study. All patients had     advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously     reported outcome for this patient group and is comparable or better than survival following     repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further     improve the results.      The investigators will conduct a randomized controlled trial to explore whether liver     transplantation in selected patients with liver metastases from CRC can obtain significant     life extension and better health related quality of life compared to patients receiving     surgical resection.      The investigators will also explore if patient selection according to nomo-grams for outcome     of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50%     or even cure from the disease.   "
137913|NCT01479595|"     This study is designed to investigate the efficacy and safety of QBX258 in subjects with     moderate to severe asthma.   "
137914|NCT01479582|"     Background:      - Cord blood banks have been set up to collect and store umbilical cord blood for     transplants. These transplants are used to treat different types of cancer. In October 2011,     the Food and Drug Administration (FDA) began considering cord blood as a biological drug.     Most of the cord blood units currently available in cord blood banks in the United States and     other countries were collected before the FDA set these new standards. The units meet     standards set by the National Marrow Donor Program (NMDP), but they were not collected,     tested, or stored exactly according to FDA standards. As a result, the new guidelines state     that they may only be used for transplant if the transplant is done as part of a study.     Researchers have set up a study to provide these cord blood units to recipients and to study     the effects of their use.      Objectives:        -  To provide access to cord blood units for recipients whose best choice for a unit meets          NMDP but not FDA standards.        -  To study the effects of these cord blood transplants.      Eligibility:      - Individuals who need to have a cord blood transplant to treat certain types of cancer.      Design:        -  Participants will be screened with a physical exam, medical history. They will also have          blood tests and imaging studies.        -  Participants will have the cord blood transplant and allow their medical data to be          collected by the study researchers.   "
137915|NCT01479569|"     Background:      - Pericardiocentesis uses a needle and small tube to drain fluid from space around the heart.     The most common reason to perform this procedure is that the fluid is interfering with heart     function. This procedure is usually guided by X-rays. However, researchers want to try the     procedure using magnetic resonance imaging (MRI) instead of X-rays. MRI guidance may be more     precise than X-rays, which can make the procedure easier and more effective.      Objectives:      - To test whether MRI guidance can improve pericardiocentesis.      Eligibility:      - Individuals at least 18 years of age who need to have pericardiocentesis.      Design:        -  Participants will have a physical exam before the procedure. Blood samples will be          taken.        -  The pericardiocentesis will be performed using MRI guidance. The procedure may take up          to 2 hours.        -  If for some reason the MRI guidance is not successful, participants will have the          regular X-ray procedure. The MRI system will be used to take high-quality pictures          afterward to check the results.   "
137916|NCT01479556|"     This study is a phase IV clinical trial with the objective of evaluating whether pain relief     associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more     efficient during the early rather than late subacute phase of spinal cord injury.   "
137917|NCT01479543|"     The present report describes the design of a clinical trial performed on healthy adult     individuals to check whether the daily intake of the new Hero strains contribute to     intestinal colonization, under safe and tolerable conditions, with a positive contribution to     health and wellbeing of healthy individuals.      Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036),     increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular     intake has positive effects on the gastrointestinal and immune system.   "
137918|NCT01479530|"     The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety     of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese     patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of     idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in     patients with end of dose fluctuations.   "
137919|NCT01479517|"     The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for     unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary     teeth for dental procedures.   "
137920|NCT01479504|"     This study is a multicenter trial.The primary objective is to estimate short-term efficacy     and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant     chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to     the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent     chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.      Secondary objectives are to evaluate the overall survival, the distant metastases free     survival, and disease free survival of patients with locoregionally advanced nasopharyngeal     carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the     regimens.   "
137921|NCT01479491|"     This study aims to analyse baseline data on IS in order to monitor the possibility of     increased risk of IS in children aged <12 months after introduction of the Rotarix     vaccination in Japan.   "
137922|NCT01479478|"     The investigators wish to determine if oral probiotic supplementation during the second half     of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational     age, thereby decreasing need for maternal antibiotic administration at time of labor. The     importance of this study is that it may offer a safer alternative to antibiotic treatment of     group B Streptococcus (GBS) colonized pregnant women.   "
137926|NCT01479426|"     Korea red ginseng has been used in maintaining vitality throughout the globally and     metabolism and actions on neurologic, cardiovascular, and endocrinologic system are studied.     KRG has been used in various ailment, and to prove its efficacy for erectile dysfunction an     international study on contries other than Korean was performed. In the present study,     subjects with borderline organic and psychogenic erectile dysfunction will be included. KRG     will be give daily, and placebo will be give as control. Outcomes including libido, erection,     sexual activity, and sexual satisfaction will be measured.   "
137927|NCT01479413|"     The investigators will investigate        1. the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA          copy numbers and the clinical psychopathology of schizophrenia, including severity of          positive and negative symptoms, obesity and metabolic syndrome.        2. the relationships between aberrant mitochondria genes (single nucleotide polymorphism of          D-loop region-related genes and haplogroup N9a), DISC1 gene polymorphism, and clinical          phenotypes in Taiwanese populations.        3. whether these biological markers could be as clinical markers in schizophrenia for a          long-term follow-up study.   "
137928|NCT01479400|"     The primary aim of this prospective study is to evaluate the effect of antipsychotics on     infant development especially neurobehavioral development which evaluated by the Bayley-III     when mothers are treated with antipsychotics throughout their pregnancy.   "
137929|NCT01479387|"     This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in     Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess     biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin     is injected to the patient for the actual treatment. The objective of this study is to assess     appropriateness and necessity of revision of the standardized criteria for image     interpretation of In-111 Zevalin by comparing assessment by the investigator and the members     of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be     recruited.   "
137930|NCT01479374|"     The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic     solution for the treatment of ocular itching associated with allergic conjunctivitis using     the Conjunctival Allergen Challenge (CAC) model.   "
137931|NCT01479361|"     Background:      - People who are infected with the human immunodeficiency virus (HIV) are at risk of getting     certain diseases. Two of these diseases are a type of pneumonia known as PCP and a brain     infection called toxoplasmosis. Most people with HIV take antiretroviral (ARV) drugs to treat     HIV and lower the risk of infections. However, some ARV drugs may make other drugs used to     treat PCP and toxoplasmosis less effective. Researchers want to test specific ARV drugs to     see if they affect atovaquone, a drug used to treat PCP and toxoplasmosis.      Objectives:      - To see if ARV drugs atazanavir-ritonavir or efavirenz lower the blood levels of atovaquone.      Eligibility:        -  Individuals between 18 and 70 years of age who have HIV.        -  Participants must be taking efavirenz or atazanavir-ritonavir, or not taking any ARV          drugs.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests.        -  This study has a screening visit and five study visits. Two of the study visits will          last about 12 hours; the other three visits will last about 1 hour each.        -  Participants will receive either a low dose or high dose of atovaquone to take for 14          days. They will record doses and any symptoms on a diary card at home.        -  After 14 days, participants will have a 12-hour visit to provide blood samples. There          will be a wash-out period with no doses for up to 6 weeks.        -  After the wash-out period, participants will switch dose levels to either the high or          low dose.        -  After 14 days, participants will have a 12-hour visit to provide blood samples.   "
137932|NCT01479348|"     Background:      - The drugs FdCyd (also called 5-fluoro-2'-deoxcytidine) and THU (also called     tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how     FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging     studies to see how the drug reacts with the cancer. This study is not a treatment study. It     is open only to people who are already on the FdCyd and THU cancer treatment study.      Objectives:      - To study how FdCyd affects advanced cancer cells.      Eligibility:      - Participants in National Cancer Institute study 09-C-0214.      Design:        -  Participants will have two imaging studies, one before starting FdCyd and THU treatment          and one after starting treatment.        -  Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The          doses will be followed by two imaging study scans and frequent blood samples.        -  This procedure will be repeated at a later date, during the FdCyd and THU treatment          period.        -  Treatment will not be provided as part of this study. This is an imaging study protocol          only....   "
137933|NCT01479322|"     Context: Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset     obesity and endocrine dysfunction that leads to cardiovascular disability and early death     within the first 3 decades of life.      Objectives: To assess the significance of risk factors for future disabilities, carotid     artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic     risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted     controls.   "
137934|NCT01479309|"     The goal of this clinical research study is to expand the research following finding the     highest tolerable dose of sodium stibogluconate combined with interferon alfa-2b in the     treatment of patients with advanced cancer that has not responded to standard treatment or     where there is no standard treatment for this type of cancer.   "
137935|NCT01479296|"     The purpose of this study is to evaluate the immune response to the Vaccine Research Center     (VRC) rAd5 HIV vaccine when the vaccine components are administered in three different ways,     in healthy, HIV-uninfected adults.   "
137936|NCT01479283|"     The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever     international multi-center randomized controlled trial in bone cancer surgery. In order to     avoid amputation for bone cancer in the leg, complex limb-saving operations are performed.     However, infections with devastating complications following surgery are common. Surgeons     from across the world will randomize patients to receive either short- or long-duration     antibiotic regimens after surgery with the goal of identifying the best regimen to reduce     these infections.   "
137942|NCT01479205|"     One aim of this study was to find out if the bronchial allergen provocation (BAP) is an     appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The     investigators had one group of children receiving SIT and one group of patients who denied a     SIT although they had an indication for it. Retrospectively the investigators analysed the     data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November     2008 till February 2010). Prospectively The investigators analysed the lung parameters and     allergic labor parameters that we got in the course of the second BAP. The investigators mean     parameter was PD20FEV1-mite. Another aim of The investigators study was to find specific     immunological differences between children who improved because of SIT and those who showed     no improvement. Thus, The investigators compared the levels of total IgE, cumulative IgE-mite     and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific     IgG4-mite after SIT.   "
137943|NCT01479192|"     The purpose of this trial is to assess the effect of fenretinide (4-HPR), a vitamin A     derivative, in reducing the incidence of breast cancer in healthy premenopausal women at     increased familial/genetic risk for breast cancer   "
137944|NCT01479179|"     The goal of Phase 1 of this clinical research study is to test the safety and tolerability of     AMG 479 when given with trastuzumab.      The goal of Phase 2 of this clinical research study is to learn if the combination of AMG 479     and trastuzumab can help to control breast cancer.      AMG 479 is designed to block tumor cells from growing and spreading.      Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking     proteins inside the cancer cell.   "
137945|NCT01479166|"     In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the     involvement of small airways (small airway disease - SAD) are to be compared with a     historical control group matched in age and gender. During the first study visit subjects are     asked to perform a pulmonary function test (spirometry, body plethysmography with helium,     determination of Trapped Air) and exhaled nitric oxide (eNO) and exhaled carbon monoxide     (eCO) measurements will be done in exhaled air. In addition, a blood sample is drawn to     describe inflammatory status. Sputum is induced as well. During the second study visit, a     non-specific bronchial provocation test(methacholine PD20 FEV1) is performed.      The aim of the study is to get a characterization of the bronchial and systemic inflammation     (IL-1ß, IL-6, IL-8, IL-17, TNF-α, NFKB, and recognition structures like TLR2 and TLR4) in CF     patients with and without the involvement of the small airways, which may point to new     treatment strategies.   "
137946|NCT01479153|"     Central venous catheters are needed in the critical care setting to administer drugs. Three     sites are available to gain vascular access: subclavian, internal jugular and femoral. Each     site has complications, but there is no randomized controlled study which compared the 3     sites.      The investigators hypothesis is that subclavian catheterization reduces the risk of major     complications compared to internal jugular or femoral.   "
137947|NCT01479140|"     Despite a relatively high prevalence of non-atherosclerotic coronary artery disease (NACAD)     among young women, the majority of these abnormalities were misdiagnosed in this population,     and thus treatments were not targeted adequately in this patient population. Furthermore, the     short and long-term cardiovascular outcomes of young women with NACAD have not been     evaluated. Given the importance of NACAD in young women, the challenges of diagnosis and     subsequent treatment, and unknown outcomes with NACAD, we propose a prospective registry to     further evaluate this population. We propose to evaluate young women (age < or equal to 55)     presenting with myocardial infarction (MI) prospectively, to diagnose the etiology of MI     differentiating atherosclerotic versus NACAD, to correlate the prevalence of FMD in other     vascular territory, and to evaluate the long-term outcome of young women with NACAD in     comparison to those with atherosclerotic CAD over a 5-year follow-up.   "
137948|NCT01479127|"     To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced     Parkinson's disease (PD) patients with severe motor complications. The complications of     medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be     investigated.   "
137949|NCT01479114|"     The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on     neutrophil production and CD11b expression.   "
137950|NCT01479101|"     The scope of this registry study is to measure chemosensitivity as defined by pCR (primary     endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor     diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant     endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free     survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by     the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to     possible novel expression profiles.   "
137951|NCT01479088|"     Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label,     active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet     HCl for the treatment of Secondary Hyperparathyroidism (SHPT) in paediatric subjects with     chronic kidney disease (CKD) on dialysis, followed by 12-month study extension.   "
137952|NCT01479075|"     Insulin has a direct effect on the energy metabolism of the brain under basal conditions and     has an effect on the hepatic glucose production, lipid metabolism and the secretion of     various hormone. The effect of intranasal insulin on peripheral metabolism in humans     supposedly is mediated by the vagus nerve.      The purpose of this study is to determine whether central insulin influences the human     peripheral insulin sensitivity of liver and muscle and whether vagus nerve stimulation can     mimick this effect.   "
137954|NCT01479049|"     The investigators previously investigated the cardioprotective effect of an     adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric     cardiac surgery, which was associated with better myocardial protective effects when compared     with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked     back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and     severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that     a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest     the heart and have better myocardial protective effects compared with conventional     hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution     and systemic hypotension.   "
137956|NCT01479023|"     2.1 Primary Objectives        1. To measure the human dosimetry of 64Cu-DOTA-U3-1287 in subjects with advanced solid          tumors (Cohort 1 only)        2. To calculate HER3 receptor occupancy (via quantification of the tumor-localized PET          signal produced by 64Cu-DOTA-U3-1287 in the absence and presence of competing unlabeled          U3-1287 in subjects with advanced solid tumors (Cohorts 2 through 5))        3. To determine the safety and tolerability of 64Cu-DOTA-U3-1287 (all cohorts)      2.2 Secondary Objectives        1. To determine the relationship between U3-1287 serum concentration and HER3 receptor          occupancy (as measured by PET/CT) in subjects with advanced solid tumors        2. To measure the tumor response rate as defined by Response Evaluation Criteria in Solid          Tumors (RECIST 1.1) in subjects with advanced solid tumors treated with U3-1287 (Part 2          only)        3. To characterize the PK exposure of U3 1287 when administered intravenously to patients          with advanced solid malignancies.        4. To measure the rate of anti-U3-1287 human antibody development in subjects with advanced          solid tumors treated with U3 1287 monotherapy      2.3 Exploratory Objectives        1. To assess tumor volume changes after U3-1287 treatment by CT or magnetic resonance          imaging (MRI) (Part 2 only)        2. To assess blood, body fluid/tissue, and tumor specimens for potential biomarkers (e.g.,          proteins and transcripts) that predict response to U3-1287        3. To obtain tumor samples for DNA extraction for analysis of potential predictors of          response to U3-1287 and any related genes as suggested by emerging data   "
137957|NCT01479010|"     This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1     blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo     cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra     (recombinant human Interleukin-1 receptor antagonist.   "
137958|NCT01478997|"     This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving     symptoms of Moderate Osteoarthritis of the Knee.   "
137959|NCT01478984|"     Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive     strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for     recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI     according to current guidelines presenting with multivessel disease. We will exclude patients     with cardiogenic shock at presentation (systolic blood pressure <90 mmHg despite drug     therapy), left main coronary disease (>50% diameter stenosis), previous coronary artery     bypass grafting (CABG) surgery, patients with Syntax Score >32 and candidated to by-pass     surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success     was defined as the achievement of an angiographic residual stenosis of less than 30% and a     thrombolysis in myocardial infarction (TIMI) flow grade III after PCI.      Patients randomized to One-Stage group were completely revascularizated in one time PCI,     whereas patients randomized to Multi-Staged group were completely revascularizated in more     time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of     600 mg before the PCI (for loading dose administered more than 6 h prior to procedure).     Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and     clopidogrel 75 mg/day for at least one month.   "
137960|NCT01478971|"     The purpose of this study is to understand the effects of a dialysis center switching its     dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and     other parameters.   "
137961|NCT01478958|"     It is well established that diet plays an important role in both the development and     progression of heart disease. Different types of dietary fat have varying effects on heart     disease risk factors. The elasticity of an individual's blood vessels is strongly associated     with heart disease risk and recent evidence suggests that dietary manipulation may influence     elasticity of the blood vessels with dietary fat (including saturated, monounsaturated and     polyunsaturated fatty acids) as a potentially important modulator. Substantial evidence     exists on the effects of monounsaturated fats (type of fatty acids mainly found in olive and     rapeseed oil), n-6 polyunsaturated fats (type of polyunsaturated fatty acids found in     vegetable oils) and saturated fat (found mainly in animal derived products) on lipid levels.     However, the influence of these dietary fats on the elasticity of blood vessels remains     unclear.The main purpose of the DIVAS study is to determine the effects of the substitution     of saturated fats with either n-6 polyunsaturated or monounsaturated fats on blood vessel     elasticity and to determine the effects of these different dietary fats on other risk factors     for heart disease including lipoproteins and inflammatory biomarkers.   "
138003|NCT01478412|"     This trial is to determine if prostate target delineation obtained through an ultrasound     based system is equivalent in accuracy to the MRI image fusion, and if alignment correction     vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray     imaging for daily prostate positioning.   "
138004|NCT01478399|"     Primary objective:      To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose     administered by subcutaneous injection to subjects with normal renal function and impaired     renal function.      Secondary objectives:      To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a     subcutaneous injection in adult subjects with normal renal function and impaired renal     function.   "
138005|NCT01478386|"     Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more     effective in treating the symptoms of knee OA then treating with viscosupplementation alone   "
137972|NCT01478815|"     Contingency management is efficacious for treating cocaine abuse, but contingency management     interventions have rarely been applied to patients with severe and persistent mental health     problems. This pilot project will estimate effect sizes of contingency management for     reducing cocaine use in patients receiving psychiatric care at a large community based mental     health program. In total, 30 cocaine abusing patients will be randomized to one of two 8-week     treatment conditions: standard care or standard care with contingency management. Patients in     both conditions will provide breath and urine samples for toxicology testing twice per week.     In the contingency management condition, patients will receive the opportunity to win prizes     for submitting cocaine negative urine samples. The investigators expect that patients     receiving contingency management will evidence reductions in cocaine use and may show     improvements in psychiatric symptoms and psychosocial functioning relative to patients in     standard care. Effect size estimates obtained from this study will be used to guide larger     scale and longer duration evaluations of contingency management for dually diagnosed     patients.   "
137962|NCT01478945|"     This study is a small pilot randomised controlled trial (RCT) comparing hand-held NB-UVB     light devices with placebo devices. These devices will be used by the participants to treat     their vitiligo at home for a period of four months. The main purpose of the trial is to     provide feasibility data that can be used to inform the design of a future multi-centre RCT     of these devices. Two hand-held UVB devices with similar manual operating system are being     tested during this pilot study. This trial will help the investigators to establish which     device is likely to be best for the main trial.      Participants will be approached in a variety of ways (through secondary care, primary care     and through direct advertising). Potential participants who contact the co-ordinating centre     expressing an interest in the trial will be given more information about the trial, checked     for preliminary eligibility, and sent an appointment for a screening visit at the closest     recruiting hospital (Nottingham or Leicester).      This screening visit will be conducted by a research nurse, but a dermatologist will also be     present in order to confirm the diagnosis of vitiligo and to confirm the participant's     suitability for UVB treatment at home. If eligible and willing to take part in the trial,     participants will provide written informed consent and baseline data will be collected. In     order to define the starting dose to be used when treating the vitiligo, a minimum erythema     dose (MED) test will be conducted.      An educational session will be provided by the research nurse outlining how to use the     devices, how to assess side-effects of the treatment and how to complete the treatment diary.     It is anticipated that the screening visit and educational session will take place on the     same day and may take up to 1.5 hours.      On the following day, a brief visit to the hospital will be required in order to examine the     skin and read the MED results (if more convenient, the educational session may be delivered     at this time). Once this has been done, participants will be given the devices to use at home     - treatment is applied 3 times per week on alternate days. They will be followed up by     telephone at week 1, week 2 and week 12 - in order to provide support and to monitor     side-effects. Participants will be asked to keep a treatment diary that records when the     treatment has been used and records side-effects experienced. Emergency contact details will     be provided in case of urgent medical need.      Participants will continue with treatment at home for the 16-week trial period. Two further     hospital visits will take place in order to record outcome data   "
137963|NCT01478932|"     The purpose of this study is to provide information on how the practicing of diaphragmatic     breathing retraining (DBR) for 8-week at home may improve the health outcomes and encourage     heart failure patients to engage in health-promoting activities by successfully controlling     their shortness of breath (dyspnea).   "
137964|NCT01478919|"     Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer.     Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after     conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue.     Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the     risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities     of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment,     could be considered. The purpose of this prospective study is to identify risk factors     associated with the presence of LRN after CER of LSTs.   "
137965|NCT01478906|"     The current study is designed to investigate the difference of plasma orexin A levels between     elderly and young patients at emergence from sevoflurane-fentanyl anesthesia who will undergo     elective lumbar surgery.   "
137966|NCT01478893|"     The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068.     Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and     smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be     evaluated.   "
137967|NCT01478880|"     First clinical studies indicate an effect of repetitive transcranial magnetic     stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size,     optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled     clinical trial we test the efficacy and safety of bilateral continuous theta burst     stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment     will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be     treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and     T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil     tilted 45°). During weeks 4-6, all subjects receive real cTBS.   "
137968|NCT01478867|"     The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by     assessment of gliadin 33-mer equivalent epitopes in feces.   "
137969|NCT01478854|"     The long term goal of this research is to establish whether NPC sparing RT techniques improve     neurocognitive outcomes compared to conventional RT for brain tumors. If the proposed study     demonstrates that NPC sparing RT is not associated with increased LR in the spared regions of     the brain compared to conventional RT, it will ideally serve as the foundation for a future     multi-institutional randomized controlled trial comparing neurocognitive outcomes in patients     treated with NPC-sparing RT versus conventional radiation therapy.   "
137970|NCT01478841|"     Diet and nutrition play an essential role in the development and the clinical expression of     the most common health problems. Overeating and obesity induce oxidative stress, which has     been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes     (T2D) and associated cardiovascular complications. The main objective of the proposed     research is to evaluate the beneficial effects of polyphenolic compounds derived from red     grape marc extracts on the cascade of events leading from overeating to oxidative stress and     insulin resistance. For that, we will study free radicals production, inflammatory markers,     adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in     healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D     patients with associated overweight). These volunteers will be randomized between a placebo     and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of     polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.   "
137971|NCT01478828|"     To determine the dose of continuous daily oral lovastatin needed to achieve MYC [v-myc     myelocytomatosis viral oncogene homolog (avian)] down-regulation in prostatectomy specimens     in intermediate-/high-risk localized prostate cancer patients.   "
138006|NCT01478373|"     The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients     with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib   "
138007|NCT01478360|"     This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial     asthma that is poorly controlled with the current standard of care.   "
138008|NCT01478347|"     The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population     potentially at risk for meningococcal disease (e.g. lab workers).      In the second part of the study additional blood samples of high responding vaccinated     subjects will be collected for the purpose of generating a control serum panel for the human     serum bactericidal assay (hSBA) tests.   "
138009|NCT01478334|"     The primary aim of the study is to investigate if 10 weeks of high intensity interval     training improve inflammatory status in patients with rheumatoid arthritis.   "
137973|NCT01478802|"     Based on recent two-center results (Eur Respir J. 2011 Sep 1. [Epub ahead of print] PMID:     21885390) we hypothesized that intermittent High-frequency oscillation (HFO) combined with     Recruitment Maneuvers (RMs) may beneficially affect the pathophysiology and survival of     patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).      Design: Randomized Controlled Trial. Intervention: Briefly, the HFO-RMs strategy of the     intervention (HFO-RMs) group will comprise RMs (3/day) and an initial HFO session of 96 hours     (HFO session can be interrupted before the 96-hour time point only if PaO2/FiO2 rises to >200     mmHg for >12 hours), followed by return to lung protective conventional mechanical     ventilation (CMV) according to pre-specified oxygenation criteria. Within days 1-10     postrandomization, patients will be returned to HFO upon recurrence of their     moderate-to-severe oxygenation disturbance. Patients of the control (CMV) group will receive     lung protective CMV.   "
137974|NCT01478789|"     The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering     of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol     esters (PS-ester), consumed within dairy products.   "
137975|NCT01478776|"     The aim of this study is the comparison between the effects of supplementation with omega-3     or placebo for 10 weeks in type 2 diabetics   "
137976|NCT01478763|"     Analysis of vitreous proteins in patients undergoing pars plana vitrectomy for proliferative     diabetic retinopathy   "
137977|NCT01478750|"     Interaction of fat with the mouth, stomach and intestine will trigger physiological responses     that will impact on the digestion, gut transit time and absorption of fat. These responses     will also influence and contribute to regulation of food intake and satiety. No systematic     research on understanding how the physiological-chemical properties of food affect the     digestion and absorption of lipids has been carried out previously. Studies have shown that     the release of free fatty acids triggers the fat-related responses. The investigators     hypothesize that the release of fatty acids depends on the colloidal state of the fat, which     changes progressively due to the pH changes and enzyme activities in the mouth, stomach and     intestine.   "
137978|NCT01478737|"     To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage     after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy     (PDRP).   "
137979|NCT01478724|"     Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and     microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility     and susceptibility to fracture. Osteoporosis is a serious public health problem that is     responsible for approximately 3 million women with osteoporosis in France, with approximately     150,000 cases per year occurring in vertebral fractures, of which only one third would be     diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the     disease increases with age, particularly among women: 10% among women aged 60 years and 20%     among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes     alterations of the immune system, decreased bone formation, microarchitectural deterioration     and a decrease in bone mass. Various factors may contribute to this decrease in bone density     such as diet, lifestyle, or the genetic background.      According to prospective studies, an overexpression of 135% of hip fractures is expected at     European level in 50 years. Therefore, it is interesting to develop new prevention approaches     aimed at maintaining the healthy aging population. Nutritional researches can consider     setting up a real prevention.      Studies suggest that specific milk protein fraction contain factors able to promote bone     formation, inhibit bone resorption in vitro. In animal model, they showed that the specific     fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption.     Furthermore, in human volunteers, a supplementation with the specific milk protein fraction     maintains balanced bone remodelling and increase bone mineral density. For example, in     healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in     the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).      The objective of this study is to assess the efficacy of daily consumption of the milk     proteins fraction on bone mineral density improvement in healthy postmenopausal women.   "
137980|NCT01478711|"     This study will use a rules-based expert system embedded in an electronic health record (EHR)     to extract, interpret, and present salient facts and recommendations related to the     healthcare of premature infants.   "
137981|NCT01478698|"     Hypothesis:      Intraperitoneal tPA and DNase is well tolerated at a number of different doses. Different     doses of tPA and DNase will have a dose-related effect on inflammatory markers (CRP and     intraperitoneal white cell count).      Aims:        1. To examine the tolerability of different doses of intraperitoneal tPA and DNase compared          to standard treatment.        2. To examine the changes in biochemical and clinical outcomes of PD Peritonitis with the          addition of intraperitoneal tPA and DNase to usual therapy.   "
137982|NCT01478685|"     The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose     (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in     combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in     subjects with relapsed or refractory solid tumors.   "
137983|NCT01478672|"     The purpose of this study is to evaluate whether the introduction of large-scale personalized     and technology supported telemonitoring and health coaching interventions produces benefits     in terms of health related quality of life, health status and empowerment of patients with a     cardiovascular disease. In addition, the trials evaluate the economical and organizational     impact of the new services and examine their acceptability by patients and health     professionals.   "
138024|NCT01478139|"     The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula     Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.   "
137984|NCT01478659|"     The proposed study will be a randomized, double-blind, parallel-arm study. Participants will     incorporate snack foods (bar/yogurt) containing 16 grams of fiber (fructooligosaccharide) or     similar snack foods without the added fiber into their usual diets. The study period will     include a 2-week pre-baseline assessment period and an 8-week treatment period. During the     2-week pre-baseline period no study foods will be consumed however dietary intake will be     assessed using a 24-hour online diet recall program. The first week of the 8-week treatment     will serve as an acclimation period where only one serving of the study foods will be given     (8 grams of fiber) per day. Participants will receive two servings (16 grams of fiber) per     day for weeks 2 through 8 of the treatment period and 24-hour online diet recalls will be     completed during weeks 4, 6 and 8.      Hypothesis:      Adults aged 18 to 50 years consuming their usual diet modified by incorporating yogurt and     snack bars containing 16 grams of chicory root fiber (Frutalose®) will decrease their usual     dietary intake to a greater extent compared to participants who receive similar snack foods     without the added fiber.   "
137985|NCT01478646|"     The purpose of this study is to determine whether different types of breathing therapies in     patients with COPD III-IV decrease dyspnea and increase activity.   "
137986|NCT01478633|"     The purpose of this study is to evaluate the efficacy and safety of galantamine in patients     who failed to benefit from donepezil (patients switching from donepezil). In clinical     practice, it is expected that galantamine will be used in patients switching from donepezil     due to the insufficient efficacy of donepezil.   "
137987|NCT01478620|"     The objective of the study is to assess safety and impact of a non-antibiotic therapy     approach with Canephron® N in the management strategy of uncomplicated lower urinary tract     infections (UTIs).   "
137988|NCT01478607|"     The purpose of the study is to assess the safety of repeated applications of QUTENZA in     reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.   "
137989|NCT01478594|"     The objective of this study is to compare the progression free survival (PFS), overall     survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of     response (DoR), quality of life, safety and tolerability of tivozanib in combination with     mFOLFOX6 and bevacizumab in combination with mFOLFOX6.   "
137990|NCT01478581|"     The primary objective of this study is to determine the efficacy of PCI-32765, both as a     single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and     refractory Multiple Myeloma (MM)   "
137991|NCT01478568|"     The study aims to evaluate if blood levels of desipramine change whilst being dosed at the     same time with daily mirabegron.   "
137992|NCT01478555|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical     administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic     solution) compared to Vehicle and DuraSite alone.   "
137993|NCT01478542|"     The purpose of this study is to improve the outcome of elderly patients with CD20+ Aggressive     B-Cell Lymphoma and to reduce the toxicity of standard used Immuno-Chemotherapy by using an     optimised schedule of the monoclonal antibody Rituximab, substituting conventional by     Liposomal Vincristine and by a PET-guided reduction of therapy in Combination with Vitamin D     Substitution.   "
137994|NCT01478529|"     A study to evaluate how much of the active compound of mirabegron comes into the blood     circulation when given as a controlled-release pill as compared to given intravenously.   "
137995|NCT01478516|"     The purpose of this study is to evaluate in a prospective study the efficacy of intravitreal     autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in vitreous     body.   "
137996|NCT01478503|"     The study aimed to compare age and gender differences for increasing doses of mirabegron when     given to healthy young and elderly males and healthy young and elderly females.   "
137997|NCT01478490|"     The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy     poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol     change whilst being dosed at the same time with daily miragebron.   "
137998|NCT01478477|"     This randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in     patients with stage I-III breast cancer receiving anastrozole, exemestane, or letrozole.     Omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients     receiving hormone therapy for breast cancer.   "
137999|NCT01478464|"     Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical     exercise. Therapists often provide manual massage with the hands to acutely relief the     soreness. Alternatives to manual hand massage can be useful for therapists. Here the     investigators examine the acute effect of a massage roller on DOMS in the hamstring muscles   "
138000|NCT01478451|"     Many people experience pain, tenderness and soreness of joint and muscles, both in sport and     working life. Pain killers can provide acute relief of pain, but may not be a feasible     solution for all people. Here the investigators examine the acute effect of massage and     exercise on induced muscle tenderness (delayed onset muscular soreness).   "
138001|NCT01478438|"     This study will determine the rate of complete tumor ablation of small breast cancers (≤     20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and     specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT     ablation as correlated to histopathology from the post-ablation excision.   "
138002|NCT01478425|"     Study design: Randomized, controlled, double-blind, parallel, multicentre multinational     clinical trial, to show superiority of an active therapy as compared to a control therapy on     intermittent or persistent Allergic Rhinitis.      Primary objective:        1. To show that a topical microemulsion is superior to a sterilized saline solution to          prevent deterioration in the health related quality of life, in patients with          intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree          or grass pollen.           Secondary objectives        2. To explore the effect of a topical microemulsion, as compared to a sterilized saline          solution, for the prevention of nasal and ocular symptoms in patients with intermittent          or persistent allergic rhinitis due to sensitization to birch, olive tree or grass          pollen.        3. To explore the effect of a topical microemulsion, as compared to a sterilized saline          solution, in the utilization of symptomatic medications, in patients with intermittent          or persistent allergic rhinitis due to sensitization to birch, olive tree or grass          pollen.        4. To assess the patient's satisfaction with a topical microemulsion treatment, as compared          to a sterilized saline solution, in patients with intermittent or persistent allergic          rhinitis due to sensitization to birch, olive tree or grass pollen.        5. To assess the safety of a topical microemulsion, as compared to a sterilized saline          solution, administered to patients with intermittent or persistent allergic rhinitis due          to sensitization to birch, olive tree or grass pollen.      This is a clinical investigation study of a Class 1 medical device product. This is a     prospective study of an active medical device versus a control medical device.      It was considered feasible to recruit 10 patients patients per center, and therefore the     study should be conducted in 10 centers. To get treatment balance within each center, a total     of 100 patients should be recruited.   "
138054|NCT01477749|"     To demonstrate that sipuleucel-T can be successfully manufactured for subjects with     metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.   "
138010|NCT01478321|"     This phase II trial studies how well giving hypofractionated radiation therapy together with     temozolomide and bevacizumab works in treating patients with high-grade glioblastoma     multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated     radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can     block tumor growth in different ways. Some block the ability of tumor to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving     hypofractionated radiation therapy together with temozolomide and bevacizumab may kill more     tumor cells.   "
138011|NCT01478308|"     This study is being conducted to determine the effectiveness of standard 3 weekly treatments     using docetaxel and prednisone with metformin in patients with castration-resistant     metastatic prostate cancer.      It is also being conducted to determine the levels of toxicity of metformin when added to     every 3 weekly docetaxel treatments in patients with endocrine resistent, metastatic prostate     cancer.   "
138012|NCT01478295|"     The purpose of this study is to evaluate the effectiveness of a structured nursing     intervention (PCE), including two types of intervention defined in the literature (coping     strategies promoting social support and empowerment through health education), which has an     effect on the perceived quality of life for the caregiver, when compared with conventional     intervention or non-support.   "
138013|NCT01478282|"     The main goal of this study is to improve safety and efficiency of clinical practice with the     new generation of oral anticoagulants.        1. To determine the effect of new oral anticoagulants (dabigatran and rivaroxaban) on          platelets and coagulation mechanisms under flow conditions.        2. To evaluate the ability of the concentrates containing coagulation factors (PCCs and          FVIIa) to reverse the effects induced by the new anticoagulants.      These studies will be carried out ex vivo in blood samples obtained from healthy volunteers     undergoing oral anticoagulant therapy at doses of proven efficacy and safety used in previous     clinical trials.   "
138014|NCT01478269|"     This study is a retrospective analysis of an homogeneous population of patients with     aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to     reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups     with a clinical and therapeutical relevance.   "
138015|NCT01478256|"     This study looks at the improvements in signs and symptoms in patients with inflammation of     the lids, blepharitis, using two different FDA approved topical antibiotic agents,     Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for     microbiologic evidence of improvement.   "
138016|NCT01478243|"     Despite their benign nature, keloids may constitute a severe aesthetic, and in some cases,     functional problem which translates to various repercussions on person's quality of life,     including much stress and insecurities.      Keloids are mostly observed between the ages of 10 and 30. Although keloid is a common     condition and the investigators can make assumptions about those living with keloids, the     investigators do not know the actual impact of the illness on the overall performance of     patients' and how this disease, day to day, is impacting their lives. The investigators are     conducting this study, aimed to investigate the psychosocial impact of keloid on daily life.     Information is collected anonymously. You must be 18 years of age or older to take this     survey. Parents can respond on behalf of their children who are not 18 years of age yet. The     online survey will take 20-30 minutes to complete.   "
138017|NCT01478230|"     Subjects will be screened within 28 days before the first study treatment to confirm that     they meet the requirements to participate in the trial. They will return to the site for two     treatment visits, at least 12 hours each, and at least one day in between visits. At each     visit treatment N1/3-I5 or Nicotine Inhaler 10 mg will be administered every hour for 11     hours. The investigator (or an appropriate delegate at the investigator site) will obtain     informed consent from each subject. Blood samples will be drawn on a special schedule. The     total predicted amount of blood sampled from each subject is 174 mL over the whole study.     Subjects will be required to follow specific smoking and dietary restrictions and rate their     urges to smoke, general liking of the product, and how easy the product is to use.   "
138018|NCT01478217|"     The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute     respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic     ultrasonographic assessment of lung recruitment.   "
138019|NCT01478204|"     The purpose of this study is to evaluate sleep quality in patients with mild to moderate     Alzheimer's disease treated with anticholinesterase drugs in clinical practice.   "
138020|NCT01478191|"     This is a retrospective analysis of a homogeneous cohort of patients with relapsed/refractory     HL that received IGEV scheme as induction therapy to HDCT and AHSCT for reassess the most     common prognostic factors and try to identify a prognostic score with clinical and     therapeutic relevance by using 6 clinical tools:        1. B symptoms(yes/no)        2. relapse in previously irradiated areas(yes/no)        3. Ann Arbor Stage (III/IV vs I/II)        4. disease status at accrual (refractory vs relapsed)        5. Early relapse within 12 months of Complete Response (CR) versus late relapse after          Complete Response (CR) lasting > l2 months,        6. extranodal involvement (yes/no).   "
138021|NCT01478178|"     The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and     the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma.     Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be     evaluated.   "
138022|NCT01478165|"     A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the     incidence of postoperative nausea and vomiting (PONV).      Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is     added to TIVA.   "
138023|NCT01478152|"     In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation     solution will be investigated in subjects with mild bronchial asthma. This dose-finding study     will estimate the minimum effective dose and will assess the safe dosage, in terms of the     quantity given to patients. The results will be compared to baseline measurements. The     results regarding Sputum measurements will be compared to measurements after placebo     administration.   "
138025|NCT01478126|"     The purpose of this study is to determine whether perioperative glutamine administration     possess protective properties on internal organs (heart and gut) in patients with coronary     atherosclerosis, operated under cardiopulmonary bypass.   "
138040|NCT01477931|"     The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride     extended release (Wellbutrin XL®) in patients with Major Depressive Disorder (MDD) with     atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended     release (Wellbutrin XL®) in patients with MDD with atypical features.   "
138041|NCT01477918|"     The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean     patients with schizophrenia.      Primary objective:      • To investigate the prevalence of the MetS in Korean patients with schizophrenia      Secondary objectives:      • To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical     antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more     antipsychotics group (polypharmacy)   "
138289|NCT01474668|"     This study will be an open-label, non-randomized, absorption, metabolism, and excretion study     of [14C]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least     a 10-hour fast from food (not including water).   "
138026|NCT01478113|"     This study aims to identify a novel enhancement strategy for residual symptoms of major     depressive disorder (MDD) Dopamine (DA) has been viewed as a pleasure neurotransmitter for     over 30 years. Yet recent data from animal and human studies suggest that dopamine has     greater effects on wanting than on liking. Therefore, the investigators of this study     have hypothesized that amphetamine/d-amphetamine (AMPH), a medication which increases     dopamine transmission in the reward centers of the brain, may have a more powerful     antidepressant effect in combination with well-being therapy (WBT), a specific type of     cognitive-behavioral therapy, which helps individuals with depression to increase their     contact with natural rewards and decrease reward-interfering thoughts.      The investigators will test their hypothesis by randomizing 40 individuals with residual     symptoms of depression, already taking an antidepressant that affects serotonin (e.g. Prozac,     Paxil), to 8 weeks of treatment with either WBT in combination with AMPH, or WBT with pill     placebo. The effectiveness of each treatment will be measured using a reliable scale, called     the Hamilton Depression Rating Scale.      The investigators have also hypothesized that people assigned to the stimulant/WBT group will     have greater improvements in functioning, well-being, and positive affectivity than those the     people assigned to the WBT/placebo group.   "
138027|NCT01478100|"     The investigators examined the feasibility of treatment planning using virtual coronary     revascularization and fractional flow reserve (FFR) CT before the invasive procedures.   "
138028|NCT01478087|"     The purpose of this study is to evaluate the clinical safety and feasibility of Mysorba in     patients with chronic non-ischemic dilated cardiomyopathy (DCM).   "
138029|NCT01478074|"     This is a single-center open-label phase I clinical trial of delivering haploidentical     natural killer (NK) cells matured ex vivo with ALT-801 followed by intravenous infusions of     ALT-801 in patients with relapsed/refractory Acute Myeloid Leukemia (AML). The study will be     conducted at M.D. Anderson Cancer Center (MDACC) and MDACC Children's Cancer Hospital in     Houston, Texas.   "
138030|NCT01478061|"     The Study plan is a post-market prospective, multi-center, open-label registry. The vein     graft failure rates for the currently commercialized C-Port devices will be compared to an a     priori rate taken from the peer-reviewed literature.   "
138031|NCT01478048|"     The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/     Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].   "
138032|NCT01478035|"     To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in     patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin     will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50     yrs.   "
138033|NCT01478022|"     This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200     and IBU and ISO combinations (200 +20) given in single dose.      This study is being conducted to support the submission for new indication in treatment of     the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular     dystrophy.   "
138034|NCT01478009|"     Upper respiratory tract infections are a major source of morbidity throughout the world.     Extracts of Korean red ginseng have been found to have the potential to modulate both natural     and acquired immune responses. The investigators sought to examine the efficacy of an extract     of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red     ginseng will be investigated in healthy subjects during the influenza season.   "
138035|NCT01477996|"     This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge)     for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for     standard recommendation regarding the optimal needle size for IVT.   "
138036|NCT01477983|"     This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different     pharmacological approaches to improve long-term outcome of catheter ablation for atrial     fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by     Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use     after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or     persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before     the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications or     substantial bradycardia identified first after ablation for persistent AF, patients will be     randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the procedure     (EAST-AF Trial).   "
138037|NCT01477970|"     The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling the     daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are at     risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian     stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled     because of OHSS were compared to 76 women of a control group. All cases of the study group     were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or     later while the follicles (> 12mm) were > 15 in total and the biggest one was ≤ 16mm in     diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of     GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before     hCG was given. A marked decrease or plateau of estradiol levels was observed the day of     oocyte retrieval while the pregnancy rate was not adversely affected when compared with an     optimum ovarian response cycles. None of the women were cancelled or developed OHSS.      In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the     ovarian stimulation, the estradiol rise could be blocked while a minimal follicular     stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.   "
138038|NCT01477957|"     The purpose of this study is:        1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid          storage can be improved by bariatric surgery        2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in          patients with obesity (degree 2-3)        3. To explore whether the steato liver occurring in patients with obesity (degree 2-3) is          associated with the degree of liver inflammation   "
138039|NCT01477944|"     To describe the new statins prescription pattern in Catalonia (getting their first     prescription for any statin, or receiving a change in their statin treatment including     switching, changing in doses or adding ezetimibe/fibrates) since September 2009.   "
138042|NCT01477905|"     The investigators attempted to determine an adequate priming volume for our infusion system,     and investigated the extent of a possible delay of the drug effect, that would result from     mechanical defects of the infusion system, with or without priming the infusion system, using     direct gravimetrical measurements of virtual infusate amounts during target controlled     infusion of 2 remifentanil diluents.   "
138043|NCT01477892|"     The purpose of this study is to evaluate safety and efficacy of continuous infusion of     remifentanil in preterm infant with mechanical ventilator for control of procedural pain     using two different dosage of remifentanil.   "
138044|NCT01477879|"     This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo     applied every 3-4 hours to herpes lesions.   "
138045|NCT01477866|"     The main aim of the present study is to test the efficacy and safety of CITOGENEX     administration in patients with colon-rectal cancer.   "
138046|NCT01477853|"     This two-phase study was to examine if 16 weeks of treatment with sitagliptin in combination     with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol     (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively.     Following a single-blind placebo run-in period, participants were to be randomized to one of     three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus     atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54),     participants were to receive either sitagliptin plus atorvastatin or glimepiride plus     atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in     combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and     that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than     sitagliptin alone.   "
138047|NCT01477840|"     The purpose of this study is to determine whether the effect of sublingual misoprostol is     better than infusion oxytocin in reduction of blood loss at cesarean deliveries.   "
138048|NCT01477827|"     The purpose of this study is to examine the amount of sunlight exposure and vitamin D status     of adolescent schoolchildren in each season throughout the year.   "
138049|NCT01477814|"     The goal of the study is to conduct a randomized clinical trial to test several office-based     strategies for improving colon cancer screening among individuals who are regular patients at     16 family practice physician offices in the state of Iowa. These offices are members of the     Iowa Research Network (IRENE), a rural practice-based research network. The interventions to     be tested are increasing in intensity from the usual care provided in the office, to     physician chart reminders, mailed educational materials to patients, a fecal immunochemical     test with postage-paid return envelope, and a telephone call designed to determine attitudes     and barriers to screening, and to motivate subjects to get screened. Our main research     questions are: 1)do attitudes toward CRC screening change after providing educational     materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a     telephone reminder, result in increased rates of CRC testing with the FIT?   "
138050|NCT01477801|"     The purpose of this study is to determine whether cholecalciferol supplementation in patients     with chronic heart failure and low vitamin D levels improves:        1. performance at six minutes walking test        2. echocardiographic parameters        3. neurohormonal imbalance   "
138051|NCT01477788|"     The objective of the study is to create a test that will discriminate between malignant and     benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about     800 women and at the end of the study the investigators will combine data from the woman's     history, the sonographic characters of the mass and serum biological markers along with the     woman's outcome (which means - whether the mass was malignant, benign, or disappeared or     remained constant with no intervention).   "
138052|NCT01477775|"     A subset of patients recruited in the main MATRIX study will be randomized after intervention     but before discharge to standard of care (the treating physician will decide which oral P2Y12     inhibitor will be added on top of aspirin) versus a customized approach based on an algorithm     which integrates phenotypic information, including but not limited to residual on-treatment     platelet reactivity assessed via VerifyNow P2Y12 Assay.   "
138053|NCT01477762|"     Posttraumatic stress disorder (PTSD) occurs in some people after exposure to events that     cause extreme fear or helplessness. The incidence of war zones worldwide and the prevalence     of violence in large cities in the U.S., increases the likelihood that people will experience     a traumatizing event in their lifetime. About 1 in 10 people who survive such events will     develop PTSD, while most people will get better over time. This suggests that some people may     have biological vulnerabilities that make it harder for them to recover. One of these     biological risk factors may be related to how stress hormones work in people who get sick.     Another is how people react to things that make them afraid or nervous, investigators have     found that PTSD patients have higher than normal fear reactions. The part of the brain that     reacts to fearful stimulation is linked to stress hormones; the purpose of this study is to     examine how these systems interact. The study will suppress stress hormones (cortisol)     production in one group of participants, while another will get a placebo. When their     cortisol is suppressed, the participants will undergo a startle study to see if their fear     responses are decreased. Investigators expect that people PTSD will show a normal fear     response when their cortisol levels are reduced, similar to people without PTSD. This     research can help discover new medicines for people with PTSD.   "
138055|NCT01477736|"     The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor     injections of botulinum toxin type A on urodynamic parameters and quality of life in patients     with neurogenic detrusor overactivity following spinal cord injury.   "
138056|NCT01477723|"     Study objectives are to verify the loss of lean mass during a hospital stay in a group of     older patients; to evaluate the effects of consuming a high-calorie complete and balanced     oral nutritional supplement; to collect post-discharge information.   "
138057|NCT01477710|"     This study will compare three methods of delivering mechanical ventilation using a test lung.     Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask     strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints     include respiratory rate and tidal volume.   "
138290|NCT01474655|"     The purpose of this study is to evaluate the changes in visual acuity, metamorphopsia, and     thickness of retinal layers after epiretinal membrane removal and to investigate factors     associated with visual function.   "
138060|NCT01477671|"     This is a descriptive prospective community-based seroprevalence study.      Primary objective:        -  To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against          dengue in healthy 5 to 10 year-old children in India.      Secondary objectives:        -  To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies          in positive (IgG) samples        -  To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in          healthy 5 to 10 year-old children in India.   "
138061|NCT01477658|"     Recent studies have shown that chronic stimulation of the right ventricle can cause     deleterious effects to cardiac function and synchronicity. The occurrence and consequences of     this phenomenon in children and young patients with cardiac pacemaker due to advanced     atrioventricular block (AVB) are still unknown.      Thus, our aims is to assess the chronic effects of cardiac pacing in children and young     patients with advanced AVB and its impact on clinical, functional and echocardiographic     parameters.   "
138062|NCT01477645|"     The purpose of this study is to determine whether use of lead free ammunitions cause more     respiratory problems than use of lead containing ammunitions.   "
138063|NCT01477632|"     This trial is conducted in Europe. The aim of this trial is to determine the extent of     bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a     marketed estradiol/norethisterone acetate (NETA) preparation.   "
138064|NCT01477619|"     The purpose of this research study is to understand whether there is any difference in the     amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study     will provide an assessment of the effect, if any, of age and body size on the safety and     tolerability profile and the pharmacokinetics of tasimelteon.   "
138065|NCT01477606|"     This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute     Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.      The primary efficacy object is to evaluate the impact of midostaurin given in combination     with intensive induction, consolidation including allogeneic hematopoietic stem cell     transplantation and single agent maintenance therapy on event-free survival (EFS) in adult     patients with AML exhibiting a FLT3-ITD.      Sample size: 440 patients      The treatment duration of an individual patient is between 18 and 24 months. Duration of the     study for an individual patient including treatment (induction, consolidation [chemotherapy     or allogeneic SCT], maintenance and follow-up period: Maximum 7.5 years   "
138066|NCT01477593|"     Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide.     Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed     routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually,     more and more Chinese male are willing to undergo it with themselves and their sons. But     there are also some complications with circumcision, such as pain, edema, infection, and     hemorrhage. Considering of that, physicians continually manage to improve their surgical     methods and analgesic techniques.      In the study of Peng, a disposable minimally invasive circumcision anastomosis device named     Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was     introduced to be applied in circumcision. And they concluded that method was quicker, safer     and less pain than the conventional techniques of incision. In present study, we carry out a     randomized controlled trail, using a different method as Peng introduced with this device in     children's circumcision (Yan's), compared with the method as Peng used and the conventional     technique in our hospital, and then observe the outcomes.   "
138067|NCT01477580|"     This study will determine whether at least one formulation of an experimental dengue vaccine     (V180) is safe and causes an immune response.   "
138068|NCT01477567|"     The main purpose of this study is to determine the safety of LY3009385 in healthy     participants. The study drug is given as a single dose, by injections under the skin. Side     effects will be documented. This study is approximately 28 days not including screening.     Screening is required within 28 days prior to the start of the study.   "
138069|NCT01477554|"     Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching     the internationally established Millennium Development Milestones (MDM) is still a distant     goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate     and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency     Training Program is an innovative training strategy based on simulations designed to train     hospital personnel to respond to obstetric emergencies. The objective of this study is to     implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in     influencing key behaviors in hospital practices, as well as measuring maternal and neonatal     outcomes in intervention versus control hospitals.   "
138098|NCT01477177|"     The purpose of this pilot study is to provide an initial assessment of the feasibility,     safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low     grade and high grade dysplasia by use in a small number of patients so as to support, or     otherwise, the development of a full-scale trial.   "
138070|NCT01477541|"     Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching     the internationally established Millennium Development Milestones (MDM) is still a distant     goal. A fundamental part of reducing maternal and infant mortality is ensuring skilled     attendance during pregnancy and delivery. This project uses an innovative strategy of     integrating professional midwives and licensed obstetric nurses into rural medical centers in     the states of Guerrero and Oaxaca, Mexico, to provide prenatal care, delivery services, and     puerperium care. The goal of the research is to increase use of best practices in intake,     labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and     improve maternal and neonatal outcomes. We posited that medical centers receiving the     intervention would provide better care and have better maternal and neonatal outcomes than     those that did not receive the intervention.   "
138071|NCT01477528|"     The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII)     patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of     thrombotic and bleeding adverse events associated with these regimes.   "
138072|NCT01477515|"     To investigate the relationship between dietary intake, body habitus, and endocannabinoid     levels in end stage renal disease patients as compared to matched controls.   "
138073|NCT01477502|"     recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are     a frequent problem, leading to significant morbidity and to a decreased quality of life.        -  until today, there is no effective prophylaxis for UTI for patients with spinal cord          injury.        -  homeopathy has been shown to be an effective treatment option in several chronic          diseases        -  study hypothesis: the addition of homeopathic assessment and treatment to a standard          prevention strategy for recurrent UTI will significantly reduce the number of          symptomatic UTI per year in this group of patients compared to standard prevention alone   "
138074|NCT01477489|"     The purpose of this study is to determine the maximum tolerated dose of veliparib that can be     given while a patient is receiving radiation therapy.   "
138075|NCT01477476|"     This is a randomized, double-blind, placebo-controlled phase 2 study. Specific aim is to     evaluate feasibility and safety of anti-IL-1 (interleukin 1) treatment in the course of     standard therapy for diabetic ketoacidosis in children and its effect on intracranial     pressure.   "
138076|NCT01477463|"     The purpose of this study is to determine the signaling pathways and changes in gene     expression in melanocytes of subjects with a history of non-melanoma skin cancer who are     exposed to oral vitamin D. If vitamin D is found to inhibit a signaling pathway involved in     the development of melanoma such as BRAF, a protein involved in cell proliferation, then oral     vitamin D could be explored further as a chemoprevention for melanoma skin cancer.   "
138077|NCT01477450|"     This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse     altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.   "
138078|NCT01477437|"     In summary, there is a clear need to improve knowledge and self-management skills in     adolescents with hemophilia. To date, there are no published accounts of self-management     programs for this population. Evidence from other chronic diseases that affects teens     suggests that by developing an interactive Internet-based program, the investigators can meet     the educational needs of adolescents with hemophilia and improve their ability to manage     their hemophilia. In the long-term, improved self-management should result in a smoother and     more successful transition to adult care and improve patient outcomes.   "
138079|NCT01477424|"     The purpose of this study is to determine if Warfarin is affected by PA21.   "
138080|NCT01477411|"     The purpose of this study is to determine if Digoxin is affected by PA21.   "
138081|NCT01477398|"     The proposed study will measure the incidence of adverse events and the decrease in time to     meet discharge criteria from the post anesthesia care unit when hypercapnic and hyperpnoea     are used during emergence.   "
138082|NCT01477385|"     This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment     of clinically caries lesions in enamel, with radiographic image restricted to the enamel or     the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth.     It also aims to compare it to the resin infiltration and to the control of proximal biofilm     through the oral hygiene.   "
138083|NCT01477372|"     The purpose of this study was to assess the effectiveness of a moderated physical exercise     program called Blooming Exercise Program (BEP) developed during pregnancy in order to control     excessive maternal weight gain and its consequences. Additionally, other objectives of the     study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy     outcomes and on the perception of the pregnant's health   "
138084|NCT01477359|"     Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS)     of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon. A     Canadian physician survey found that most physicians do not investigate for CS as a     possibility in these situations. Thus many patients with clinically important CS are going     un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients'     leads to significant mortality and morbidity.      There are no published clinical consensus guidelines on treatment of CS. Corticosteroid     therapy is advocated by most experts. This is based on very modest data from small     retrospective observational studies using variable definitions of clinical response. The     effect of corticosteroid treatment on the clinical course of CS has not been studied in     prospective studies and will be one of the aims of this project. Recent physician surveys     regarding CS, in Canada and the US, found that current clinical practice varies widely. The     2008 American College of Cardiology/American Heart Association/Heart Rhythm society     guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent     sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS.      A multi-center collaborative approach to study CS is greatly needed. The investigators     propose exactly that i.e. a multi-center prospective cohort to start to answer clinical     questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The     group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists,     cardiac imaging specialists with extensive experience in imaging of sarcoidosis and     biostatisticians. The research will be in two phases and his current application is for Phase     1 (pilot) of the prospective cohort. Twenty Canadian centers have committed to participate in     this pilot study.   "
138085|NCT01477346|"     The purpose of this study is to determine in community-derived patients with gout the     effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects     recommended best practice (including patient information concerning gout, its prognosis and     its non-pharmacological and drug options).   "
138086|NCT01477333|"     The purpose of this multi-center, open-label, safety and tolerability study was to assess the     addition of oral treprostinil (UT-15C sustained release [SR] tablets) to subjects currently     receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period,     the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk     test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World     Health Organization (WHO) Functional Class, and safety assessments.      Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were     receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies     (endothelin receptor antagonists [ERAs] and/or phosphodiesterase type 5 inhibitor [PDE5-I],     if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg     UT-15C SR.   "
138087|NCT01477320|"     study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral     nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of     incidence of overt and significant GI bleeding related to stress gastropathy.   "
138088|NCT01477307|"     In patients with NAFLD/NASH, changes in liver lipid composition and function tests following     a short dietary intervention are associated with changes in gut microbiota   "
138316|NCT01474317|"     The purpose of this study is to demonstrate that untrained subjects who have diabetes can     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose     results.   "
138089|NCT01477294|"     The main purposes of this randomized cross-over trial are to characterize and compare the     effects of a moderate dose of caffeine intake in healthy physically active males on hydration     and energy metabolism specifically:        1. Total body water and its compartments (intracellular and extracellular) assessed by by          dilution techniques, and hydration state by urine specific gravity;        2. Total energy expenditure by double labeled water, resting energy expenditure by indirect          calorimetry, and physical activity energy expenditure;        3. Energy expenditure in physical activity of daily living, in particular duration and          intensity of activity.        4. If the changes occurred between placebo and caffeine ingestion on the main outcomes were          dependent on specific covariates, namely body composition and dietary intake.   "
138090|NCT01477281|"     The objective is to evaluate the effectiveness of the safety of Daflon in decreasing symptoms     resulting from chronic venous insufficiency when compared with Daflon.   "
138091|NCT01477268|"     Major depression is a very common health problem affecting older persons. The present     standard of treatment is with medications called antidepressants. Antidepressants have been     studied extensively in older persons with normal brain function and have been shown to be     effective. However, certain types of brain dysfunction called executive impairment     (inability to do higher order thinking) may lead to poor treatment outcomes. This study will     compare how older depressed people with different levels of executive impairment respond     differently to standard antidepressant treatment. Knowing this information will lead to more     rational targeting of available treatments, leading to improved treatment outcomes.   "
138092|NCT01477255|"     This investigation seeks to determine the feasibility of an electronic diary methodology     among pediatric cancer patients and healthy matched controls. Levels of study participation     and compliance will be assessed to assist with determining overall feasibility. Results will     offer insight into the effectiveness of this means of data collection with a pediatric     oncology population, and will examine how psychosocial and contextual factors contribute to     the resiliency that has been demonstrated by children with cancer. Findings will provide data     for the design and implementation of a future, larger-scale study with this pediatric     population that implements an electronic daily diary methodology.   "
138093|NCT01477242|"     The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this     evaluation, the investigators will perform a multi-center, double-blind, placebo-controled,     randomized study. The investigators assumption is that oral ondansetron prior to     intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.   "
138094|NCT01477229|"     Rectal cancer is a common type of cancer occuring more frequently in men but also common in     women. Almost 60% of the patients survive 5-years and the treatment has been continuously     developed in the last three decades. The aim of the QoLiRECT study is to increase the     knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and     socioeconomic burden in an unselected population of rectal cancer patients.   "
138095|NCT01477216|"     The aim of this study to investigate methodological aspects that may affect glycemic index     (GI) and insulinemic (II) values. In addition, we will measure GI and II values for typical     Finnish carbohydrate-rich foods and provide a database of GIs for Finnish foods.      The specific aims of this study are:        -  to compare glycemic responses and GIs analyzed from capillary and venous blood to          compare glucose against white bread as the reference food, and to study the effect of          number of reference tests on GI values. For each setting of the tested parameters, we          determined the glycemic indices of rye bread, oatmeal porridge and instant mashed potato        -  to examine the glycaemic and insulinaemic responses of a mashed potato-based meal when a          high fat food (rapeseed oil) or a high protein food (chicken breast) or fat, protein and          salad together were added to the meal. Furthermore, we studied how the predicted and          measured GI values of the mixed meal differed from each other.        -  to examine the effects of two different coffee portions with glucose and          caffeine-containing soft drinks on postprandial glucose and insulin responses. Further          objectives were to study how coffee and different accompaniments affect glucose and          insulin responses.        -  to measure GI values for typical Finnish foods        -  to study the effects of berries on glycemic and insulinemic responses        -  to examine the effects of overweight and glucose tolerance on the glucose, insulin and          lipid responses to an HGI meal and an LGI meal.Furthermore, the second aim was to study          the effect of BMI and glucose tolerance on the GI measured.        -  to compare methodological choices in insulin measurement        -  to investigate the effect of alcohol on postprandial glucose and insulin responses, and          to determine glycemic and insulinemic indices values for beer and non-alcoholic beer   "
138096|NCT01477203|"     MAN-BIOPSY pursues the concrete research question whether novel biological and     psycho-physiological clusters or categories can be defined to improve treatment and minimize     side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and     endocrinological parameters. One major aspect of our research approach is its focuses on the     identification of dysfunctions in fundamental information processing mechanisms and     neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.      The main objectives of MAN-BIOPSY are therefore        -  to identify biological and psycho-physiological parameters for major depressive          disorders and anxiety disorders, and        -  to identify predictive markers for treatment response and type/severity of side effects          for these disorders.   "
138097|NCT01477190|"     This is a blinded randomized controlled trial in patients undergoing laparoscopic colon     surgery. The aim of this study is to assess whether spinal analgesia with a mixture of     bupivacaine and morphine provides better pain relief than systemic morphine in a group of     patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS)     program.      Twenty patients will receive spinal analgesia and twenty patients will receive only Patient     Control Analgesia (PCA).   "
138099|NCT01477164|"     Muscle proteins accumulate damage during aging and leads to the loss of muscle mass and     function in older people. Exercise can increase the making of new proteins and removal of     older proteins, but it is not known if the effect changes with aging or type of exercise. The     investigators will determine the ability for endurance, resistance, or a combination of     exercise training to remove older-damaged proteins and make newer-functional muscle proteins     in groups of younger and older people. The investigators will particularly study protein that     are involved with energy production (mitochondrial proteins) and force production     (contractile proteins).      Hypothesis 1: Older people will have greater accumulation of damaged proteins than younger     people.      Hypothesis 2: Aerobic exercise will decrease the accumulation of damaged forms of contractile     and mitochondrial proteins in younger and older people.      Hypothesis 3: Resistance exercise will decrease the accumulation of damaged forms of     contractile proteins in younger and older people.   "
138126|NCT01475773|"     Is their a association between the objective and subjective severity of a malocclusion,     quality of life and self-esteem/personality (as modifier between objective/subjective     severity and quality of life (cfr study Agou et al., 2008) ? A second goal is to compare     motivation and expectations and the objective and subjective severity of the malocclusion on     the other hand.   "
138100|NCT01477151|"     Anesthesia practice in the 21st century is increasingly outcomes-oriented and evidence-based,     but there remain significant gaps in our knowledge, even for commonly-encountered clinical     situations. Currently, the two most commonly used drugs used for maintenance of anesthesia in     cardiac surgical patients are isoflurane and sevoflurane. There is a belief among many     cardiac anesthesiologists that sevoflurane is a better cardiac anesthetic than isoflurane,     but there is very little data to support this notion. In fact, very little is known about     their comparative effects on important patient outcomes because there has not been a large     head-to-head prospective randomized clinical trial. This project will supply the data     necessary to critically compare the two anesthetics.   "
138101|NCT01477138|"     Background:        -  Potential negative effects of pacing in the RV-apex are well documented        -  However, study results comparing septal / RVOT-pacing versus RV-apical pacing          controversial.        -  The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with          an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE trial          [DANPACE, ESC 2010, Stockholm].      Aim:      - to evaluate chronic effects of proven right ventricular septal compared to minimized right     ventricular septal pacing in patients with SSS      Inclusion criterion:      -Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)      Exclusion criteria:        -  Life expectancy < 2 years        -  Age <18 years        -  Noncompliance with regard to participation in the study        -  Pregnancy        -  AV block ° 2 and higher        -  Permanent atrial fibrillation        -  Heart failure NYHA III and IV, reduced LV-EF <40%        -  ICD indication        -  Acute coronary syndrome. PCI or CABG <3 months        -  Heart transplant        -  Placement of septal RV electrode is not possible      Study design:        -  Prospective, monocentric, randomized, double-blinded        -  Run-in phase: for weeks AAI [R]-DDD [R]        -  Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R]          versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].        -  FU: 6 and 12-months      Primary endpoints:      -LV ejection fraction and end-systolic LV volume after 12 months.      Secondary endpoints:      -LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden,     % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope;     QoL scores (SF-36) after 12 months.      Statistics/sample size estimation:      In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups     after 12 months:        -  90% power/alpha 5%: 84 patients per group        -  80% power/alpha 5%: 63 patients per group             -  10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1               error Analysis intention-to-treat and based on the finally programmed pacing mode.      Material        -  PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)        -  pacing leads: market-released standard active electrodes        -  RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow          <150 ms / inferior axis)   "
138102|NCT01477125|"     The purpose of this study is to evaluate whether computerised working memory training     improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life     in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a     high-security prison facility (N=50).   "
138103|NCT01477112|"     Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms,     the objective is to determine the effect of supplementation with β-carotene to type 2     diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant     plasma capacity, using doses similar to the daily nutritional requirement.   "
138104|NCT01477099|"     The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12%     could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may     be an important reservoir of pathogens that could cause pneumonia.   "
138105|NCT01477086|"     Sarcopenia is the loss of muscle mass and function that accompanies aging. The term     sarcopenia comes from the Greek sarx (flesh) and penia (loss).      Sarcopenia is a topic of great interest to geriatricians, and from 2010 discussing the     possibility of considering it as a geriatric syndrome.      Diagnostic criteria are reduced muscle mass, reduced strength and impaired physical     performance. The presence of muscle mass reduction set presarcopenia diagnosis, when combined     with one of the other two are talking about sarcopenia and when are the three is defined as     severe sarcopenia.      The hypothesis of our study is that sarcopenia is highly prevalent in older people with hip     fracture. The increase in inflammatory indices of older people, along with bed rest,     represent factors that accelerate the development of sarcopenia. These factors together could     be the base of the high percentage of patients who do not recover the degree of autonomy     before the fracture.   "
138106|NCT01477073|"     The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a     multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female volunteers,     in comparison with two marketed comparator products.   "
138107|NCT01477060|"     Target Population: female patients with HER2-negative, ER and/or PgR positive breast cancer     in progression after first-line hormonal therapy.      The study rationale is based on the potentiality of reversing endocrine-resistance by     Lapatinib        -  Activity on compensatory-adaptive mechanisms of hyperactivity of signals generated by          HER2 family        -  Modulation of energy balance and signals associated to survival through AMPK activation          (via Calmodulin) Metformin        -  Indirect mechanism, through reduced insulin receptors and IGFR stimulation, with reduces          proliferative effects downstream        -  Direct mechanism, through AMPK activation (via LKB1), with reduced protein synthesis          (mTOR inhibition) and increased availability of intracellular energy Lapatinib and          Metformin        -  AMPK Doubleactivation, through different potentially additional mechanisms.        -  Inhibition of proliferative mechanisms for interference on various intracellular target             -  IR (A e/o B); IGFR             -  EGFR; HER2      Primary objectives :      1. To assess the rate of patients free from disease progression at 3 months from     randomization      Secondary objectives :        1. To assess the overall response rate        2. To assess the duration of response        3. To assess 3-years overall survival rate        4. To assess tolerability of each proposed treatment Female patients with HER2-negative, ER          and/or PgR positive breast cancer in progression after first-line hormonal therapy will          randomized to receive: hormonal therapy + lapatinib or hormonal therapy + metformin or          hormonal therapy + metformin + lapatinib with a ratio 1:1:1.      For each arm of the study the following sample size is required:        -  First step: 23 patients, for a total of 69 patients in all 3 arms        -  Second step: further 33 patients, for a total of 168 patients in all 3 arms.   "
138122|NCT01476865|"     The purpose of this study is to establish the normality of sonographic synovial measures in     joints more affected in rheumatoid arthritis patients and establish, in those joints, a     sonographic value of synovium predictive of rheumatoid arthritis.   "
138108|NCT01477047|"     Prolonged wound drainage following total joint replacement surgery has been shown to be a     predictor of postoperative infection. Several factors have been associated with delayed wound     healing and increased risk of infection. Namely hypertension, obesity, diabetes, smoking and     autoimmune disease have been shown to have a detrimental effect on wound healing. The purpose     of this study is to verify those findings and determine additional pharmacological, surgical     and patient related factors that may result in prolonged wound drainage, prolonged hospital     stay and increased risk of infection   "
138109|NCT01477034|"     Chronic, low-grade adipose tissue inflammation is a major risk factor for type 2 diabetes     mellitus. The cause of adipose tissue inflammation has remained largely unclear. We     hypothesize that vitamin D deficiency predisposes individuals to the development of adipose     tissue inflammation, and that treatment of vitamin D deficient subjects with high dose     vitamin D will reduce adipose tissue inflammation.   "
138110|NCT01477021|"     This phase I trial studies the side effects and how well giving autologous T cells with     cyclophosphamide works in treating patients with soft tissue sarcoma that is metastatic or     cannot be removed by surgery. Biological therapies, such as cellular adoptive immunotherapy,     may stimulate the immune system in different ways and stop cancer cells from growing. Drugs     used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Giving autologous     T cells together with cyclophosphamide may kill more tumor cells.   "
138111|NCT01477008|"     The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic     Cartilage Repair Implant (BiCRI, Exactech Taiwan) compared to marrow stimulation in the     treatment of chondral and osteochondral lesions located on the medial femoral condyle,     lateral femoral condyle, or trochlea of the knee. The hypothesis is that the BiCRI provides     an improvement in pain and function as compared to baseline, that is no worse than marrow     stimulation at 1 year.   "
138112|NCT01476995|"     The objective of this study is to determine whether the finger tip images captured by the     EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale     that characterizes trends consistent with known diagnoses identified by medical doctors.     Specifically, the investigators hypothesize that the organ system involving any of a series     of known active diagnoses will be identified in the EPIC ClearView Response Scale report with     the intention of providing potential triage capabilities.   "
138113|NCT01476982|"     The primary objective of this feasibility study is to determine whether it is possible to     conduct a study of the ClearView scan among patients under evaluation for acute     cardiovascular events, as well as give insight into the performance of the ClearView scoring     algorithm with respect to this patient population. The EPIC™ scan is a bio-electrographic     tool that may assist the health care provider in rapid assessment of the systemic origin of     the patient's presenting symptom(s). The EPIC ClearView is a potentially valuable resource     that may benefit an emergency department (ED) by offering expedited chest pain etiologic     differentiation capabilities. The subsequent results have the potential to include more rapid     chest pain patient diagnosis and appropriate disposition of non-cardiac chest pain (rule     out MI); optimized precious resource expenditure (nursing, physician, inpatient or     observation bed, etc.); lower costs to facility, patient and insurance company; and greater     patient satisfaction rates due to decreased ED wait time.   "
138114|NCT01476969|"     The purpose of this study is to determine whether Remote Ischemic Perconditioning is     effective on Acute kidney injury in adult valve replacement.   "
138115|NCT01476956|"     Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug)     DMARD therapy or about to change DMARD therapy.      Disease activity will be monitored systematically every 3 months by the Disease Activity     Score.      Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be     made according to specific recommendations for patients receiving these therapies.      Biomarker samples will be collected every 3 months and prior to change in DMARD and/or     anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for     biomarker studies and processed according to the international committee of Outcome Measures     in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A     urine sample (20 ml) will also be taken and processed as for serum.      Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).      Patients will be followed for 2 years.   "
138116|NCT01476943|"     The primary purpose is to describe the pattern of Belatacept use at the time of transplant     and up to three years post-transplantation for all Belatacept treated patients.   "
138117|NCT01476930|"     Migraine is the most common recurrent headache. Current therapy of migraine headache consists     of multiple drug groups for control of attack and prophylaxis against recurrent attacks.     Emerging alternative medicine worldwide led investigators to evaluate the efficacy of cupping     therapy plus SERKANGABIN syrup in treatment of migraine headache. Severity, duration and     frequency of attacks of migraine headache evaluated in two groups during six months from     presentation.   "
138118|NCT01476917|"     The Study is a multi-center, prospective, open label, single-arm, three-month, long-term     study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA).     The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.   "
138119|NCT01476904|"     E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be     able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in     a double-blinded manner.   "
138120|NCT01476891|"     For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation can     decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal growth     and spirituality, and improve quality of life and sleep. Online MBSR may improve the     accessibility of MBSR programs to underserved cancer patients who are unable to attend     available in-person groups. This study will examine whether patients are willing to     participate and complete the program, and also whether the online program improves mood and     stress.   "
138121|NCT01476878|"     The investigators plan to study high dose, single treatment radiation, using a plastic mask     instead of a head frame that pins into a patient's skull. The investigators need to (1)     quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that     without the head frame the tumour control rate and risk of complications are similar to our     previous experience using the head frame.   "
138123|NCT01476839|"     This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal     antibody therapy when given together with combination chemotherapy before stem cell     transplant and to see how well it works in treating patients with primary refractory (did not     respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma. Radiolabeled     monoclonal antibodies can find cancer cells and carry cancer-killing substances to them     without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide,     cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells,     either by killing the cells, by stopping them from dividing, or stopping them from spreading.     Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may     kill more cancer cells   "
138124|NCT01475799|"     The purpose of the study is to determine the safety and performance of the Direct Flow     Medical study valve and delivery procedure.   "
138128|NCT01475747|"     Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of ~ 9250     adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is     designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial     will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the     standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. One     of the pre-specified secondary outcome is the progression of kidney disease. In this     ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators     plan to take advantage of the unique opportunities afforded by the parent study to examine     issues that are of significant public health importance.      This is an observational study in SPRINT participants. This study will examine     mechanistically, the factors affecting the progression of atherosclerosis in CKD.   "
138129|NCT01475734|"     This is a stepped glucose clamp study designed to investigate the effect of treatment with     albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in     subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given     prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate     that albiglutide increases insulin secretion and decreases glucagon levels in a     glucose-dependent manner.   "
138130|NCT01475721|"     The purpose of this study is to assess whether the risk of serious asthma-related events     (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and     adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol     combination is the same as those taking inhaled fluticasone propionate alone.      ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.   "
138131|NCT01475708|"     The investigators will compare the outcome of three groups of erythema migrans patients     treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and     with severe symptoms that require lumbar puncture.   "
138132|NCT01475695|"     Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose     of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected     for a minimum of 14 days following study drug administration. Safety and tolerability will be     monitored throughout the study. A follow-up visit will occur 7-14 days after study drug     administration.   "
138133|NCT01475682|"     Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing     cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces     the risk of cardiovascular morbidity and mortality.   "
138134|NCT01475669|"     The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can     reduce the amount of donor blood products needed during complex cardiovascular surgery, and     that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo     infusion during surgery. This will be in addition to the standard treatment, which is donor     blood or blood products. Placebo does not contain any effective medicine.      The study is randomised. This means that the likelihood that subjects will get FCH or placebo     is 50%. To make the comparison between FCH and placebo as fair as possible, the study is     double blind. This means that neither the subjects nor the study doctor will know if FCH or     placebo is administered. If necessary, the study doctor can find out which treatment the     subjects are receiving.   "
138135|NCT01475656|"     The purpose of this research study is to learn how well the medication levetiracetam (Keppra)     works to treat seizures in full term and premature babies. Levetiracetam is commonly used in     babies with seizures at Cincinnati Children's Hospital, especially if the seizures have not     been stopped by other medicines. The Food and Drug Administration (FDA) has approved the use     of levetiracetam for older children (over the age of 4) but not for infants. Even though it     is not FDA approved for this age group, doctors at Cincinnati Children's use the medicine as     a second drug in babies whose seizures are not stopped by phenobarbital. Some doctors are     concerned that phenobarbital is not the best medicine to treat seizures in babies, so     researchers are trying to study other medicines.      In this study, the investigators are looking at how well levetiracetam stops or slows down     seizures in babies. The investigators are also studying the blood levels of levetiracetam to     learn more about how the medicine is processed by the body and what level of medicine in the     body works to stop seizures. The investigators are checking labs before and after giving the     dose to make sure the medication does not cause any changes in blood counts, kidney function,     or liver function. The investigators are following all of the babies in the study after     hospital discharge to see if the parents notice any side effects of the medication. Babies in     the study will come back to the High Risk Follow Up Clinic at Cincinnati Children's at 6     months of age for a visit with a neurologist and a neonatologist and developmental testing.   "
138137|NCT01475630|"     The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain     and mandibular function in patients with anterior disc displacement without reduction (ADD-R)     or closed lock of the TMJ and this in a randomized controlled trial design.   "
138138|NCT01475617|"     Approximately 33% of the US adult population can be classified as obese based on body mass     index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed     every year for the treatment of clinically severe obesity. Roux-en-Y gastric bypass (RYGB)     is the most common bariatric procedure performed in the United States and has both     restrictive and malabsorptive components. Despite the success of this procedure in creating     long lasting weight loss, vitamin and iron deficiencies are common and can lead to     significant morbidity if not appropriately addressed. Despite the American Association of     Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic &     Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation     recommendations, there has been very little prospective research conducted to assess the     efficacy and compliance of these micronutrient interventions.      This prospective randomized controlled clinical study will evaluate the efficacy of a novel     vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative     bariatric patients.   "
138139|NCT01475604|"     The purpose of this study is to determine the effectiveness of pulsed radio frequency (PRF),     a type of electromagnetic field treatment with the Ivivi Torino II for reducing     post-operative narcotic use in patients recovering from Total Knee Arthroplasty.   "
138140|NCT01475591|"     The aim is to evaluate effects of early individually tailored web-based multimodal     rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary     health care. The aim is also to study if this early web-based pain rehabilitation program is     more cost-effective than only multimodal rehabilitation. Randomization will be done at each     primary health care centre after screening to 1) Multimodal pain rehabilitation with     web-based education and coaching support or 2) multimodal pain rehabilitation. The     investigators suggest a clear rehabilitation chain where a web-based program is     developed,evaluated and ready to implement if it shows positive effects on work-ability     and/or is cost-effective. The research and implementation will be performed in a close     cooperation with Luleå University of Technology.   "
138141|NCT01475578|"     The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on     clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study     structure planned in this project, the dosage and study structure of phase III study can be     confirmed.   "
138142|NCT01476813|"     dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF     in COPD patients.   "
138143|NCT01476800|"     The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose     ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone     and in combination with ketoconazole in healthy adult volunteers.   "
138144|NCT01476787|"     The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide     and rituximab in controlling the Follicular Lymphoma disease and also increase the length of     response compared to the available standard combination chemotherapy treatment for Follicular     Lymphoma.   "
138145|NCT01476774|"     This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group,     multi-center, safety and efficacy study.   "
138146|NCT01476761|"     The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device     in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in     a post-market approval study.   "
138147|NCT01476748|"     The purpose of this study is to find out how much a trocar might slide during a typical     laparoscopic hysterectomy. We also want to find out if there is a difference between how much     three commonly used trocars slide and if a device called LaproStop has an effect on the     slippage.      Patients will be randomly assigned into the different trocar groups. After this assignment     has been made, we will then assign the Laprostop to one of the two trocars by chance.   "
138148|NCT01476735|"     This is a prospective, randomized, single-blind study designed to evaluate the influence of     individual approach on bowel preparation quality for colonoscopy. The investigators compare     split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified     split-dose PEG regarding predictors of inadequate preparation for colonoscopy.   "
138149|NCT01476722|"     The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting     solution in silicone hydrogel and soft contact lens wearers.   "
138150|NCT01476709|"     Rationale: evaluate the potential of the photonic needle (photonic needle technology) to     discriminate tissues that are relevant to recognize during intraforaminal (transforaminal)     epidural injection on lumbar level.      Objective: The primary objective of this study is to investigate the potential of the     photonic needle to discriminate between correct and incorrect placement of the needle tip in     the target area of the procedure (M4 - tissue), as confirmed by contrast-enhanced     fluoroscopy. The secondary objectives are to investigate the differences in the optical     signals obtained with the photonic needle at a set of different pre-defined positions (M1, M2     and M3) encountered along the needle trajectory during above-mentioned procedures, and to     detect potential intravascular positioning of the needle-tip at the target point (M4 -     blood), Study design: this is a single blind observational study. Study population: Patients     who have radicular pain on lumbar level, for example caused by disc herniation, and/or     lateral recessus stenosis and/or radiculopathy eci.      Main study parameters/endpoints: The main study parameters are: 1) successfully acquired     diffuse reflectance spectra obtained at measurement point M4: midforaminal, halfway the     foramen (the target treatment location) as encountered during image-guided intraforaminal     injections on lumbar level, 2) confirmation of target area with fluoroscopy and injection of     contrast fluid (gold standard), 3) Certainty score on a 3-point scale (1 = uncertain, 2 =     certain, 3 = very certain) will be provided by the physician. The type of tissue present at     the needle tip will be based on the information available from imaging .      The secondary study parameters are: 1) successfully acquired diffuse reflectance spectra     obtained at measurement points M1-M3: M1 in muscle, M2 extra-foraminal, M3 foraminal at a     distance 1/3 of the diameter of the foramen from the entrance of the foramen, as encountered     during image-guided intraforaminal injections on lumbar level, 2) successfully acquired     diffuse reflectance spectra obtained at measurement point M4, in case of a vascular puncture     (M4-blood), 3) confirmation images by ultrasound imaging at location M1 as described above,     4) confirmation images by fluoroscopy at locations M2 and M3, 5) digital subtraction     angiography images after contrast injection at location M4, confirming vascular penetration     (gold standard for vessel puncture), 6) Certainty score on a 3-point scale (1 = uncertain,     2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue     present at the needle tip, based on the information available from imaging at M1 and at M4.   "
138151|NCT01476696|"     The purpose of this study is to determine the correct prasugrel dosage to be given to     children with sickle cell disease (SCD).   "
138152|NCT01476683|"     This study is designed to compare the pharmacokinetics of four products used for treatment of     acute diarrhea.   "
138330|NCT01474135|"     This is a double-masked, randomized, controlled study assessing the safety and ocular     hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to     Travatan® Z in patients with elevated intraocular pressure   "
138153|NCT01476670|"     The normal cerebral blood flow is guided by factors such as cerebral autoregulation (CA) and     carbon dioxide reactivity (CO2R). Authors have demonstrated that CA and CO2R may be impaired     in presence of intracranial tumors.Most studies pertaining to assessment of CA and CO2R in     patients with brain tumors is limited to supratentorial tumors. Due to their anatomic     location, posterior fossa tumors result in obstruction of ventricular outflow, produce     hydrocephalus and features of raise intracranial pressure (ICP). It is possible that lesions     in the posterior fossa may affect CA and CO2R. It should also be noted that posterior fossa     surgeries are carried out in positions such as prone, lateral and sitting. Altered surgical     positions themselves affect systemic hemodynamics which may influence cerebral blood flow;     with presence of anesthetics further compromising the blood flow to the brain. Understanding     the homeostatic mechanisms of CA and CO2R may help in deciding proper positioning of patients     and maintenance of intraoperative hemodynamic.      The aim of this observational study was to evaluate CA and CO2R in patients with posterior     fossa tumor prior to surgical decompression of the lesion.   "
138154|NCT01476657|"     The purpose of this study is to determine the safety, maximum tolerated dose and     pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.   "
138155|NCT01476644|"     Hypothesis 1: Self-reported health-related quality of life decreases as vision impairment     worsens in subjects with glaucoma.      Hypothesis 2: Changes in health-related quality of life are associated with changes in     clinical measures of vision and performance-based measures of visual function.   "
138157|NCT01476618|"     The purpose of this study is to gather information from VISN 19 Denver VA mental health     professionals regarding their perspectives of necessary resources to provide best practice     mental health service to Operation Iraqi Freedom (OIF)/ Operation Enduring Freedom (OEF)     Veterans. Specifically, this study aims to describe provider perspectives regarding the     following: a) clinical needs of OIF/OEF Veterans; b) collaboration and referral processes; c)     barriers to providing optimal treatment to this cohort d) provider needs and resources that     may improve service delivery to this cohort; e) provider perspectives regarding psychiatric     outcomes in this cohort; and f) professional satisfaction. Support for this study is provided     by previous research evaluating Veteran's Administration (VA) needs to provide service to     OIF/OEF Veterans (Sayer, et al. 2009; Friedmann-Sanchez, et al. 2008).      The above information will be obtained using semi-structured interview. Hypotheses are not     provided as this is an exploratory qualitative study.   "
138158|NCT01476605|"     While evidence does not identify any conventional therapy as definitive for chronic lateral     epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support     rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE.     The proposed study will conduct a pilot RCT assessing 2 PrT solutions and PRP injections     commonly used in the treatment of moderate-to-severe tennis elbow using clinical,     biomechanical and radiological outcomes. Data from this study will support a future     confirmatory study to find an effective treatment for moderate-to-severe tennis elbow. In     support of this goal, the investigators propose the following research questions.      Does PrT or PRP, compared to waitlist control:        1. improve pain- and function-dependent, CLE-specific quality of life among adults with          CLE, as assessed by a validated questionnaire, the elbow-specific Patient-Rated Tennis          Elbow Evaluation?        2. improve upper extremity performance among adults with CLE as assessed by a blinded          assessor using elbow-specific, effort-dependent biomechanical measures of grip strength          (pain-free and maximal), stiffness, effective mass and damping        3. improve the radiologic appearance of several pathologic features of CLE as evaluated          using imaging studies of lateral elbow structures: ultrasound to assess a)          neovascularity (color Doppler), b) hypoechogenicity (grayscale US), and c) tendon          stiffness (acousto-elastic strain gauge technique) using standardized, 0-3 severity          scales, and d) MRI to assess the overall common extensor tensor tendon disease severity          using a standardized 0-3 scale?        4. provide satisfying treatment to subjects as assessed by a treatment satisfaction survey          and a qualitative exit interview?   "
138159|NCT01476592|"     Resveratrol has been shown to activate a protein called Notch-1. Signaling of Notch-1 has     been shown to prevent tumor cell growth. Resveratrol has also been shown to prevent growth of     tumors in mice. The purpose of this study is to examine the effects of resveratrol and     Notch-1 on neuroendocrine tumor tissue and to examine how people with neuroendocrine tumors     who take resveratrol for up to three months tolerate the product.   "
138160|NCT01476579|"     This study is evaluating the performance of modern CT coronar angiography with low radiation     technique compared to conventional invasive coronar angiography. The patients recruited will     already be accepted for invasive coronary angiography based on clinical presentation, ECG and     biochemical parameters. An all-comers design to avoid selection bias and no additional     B-blockers will be used prior to CT angiography. The hypothesis is that it is possible to     rule out significant coronary artery disease with sensitivity > 95 % and negative predictive     value > 95 % with very low radiation doses.   "
138161|NCT01476566|"     This study will explore the possible effect of a tailored educational intervention towards     general practitioners in Norway, in order to improve the quality of treatment for heart     failure in general practice.   "
138172|NCT01476423|"     This observational registry is conducted in Europe, Asia, Africa and the United States of     America (USA).      The purpose of the registry is to evaluate the efficacy and safety of activated recombinant     human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during     invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or     present refractoriness to platelet transfusions. Attention will be directed towards     complications related to thrombo-embolic events and concomitant medications especially     antifibrinolytics.   "
138182|NCT01476293|"     The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects     receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an     indication that the PIV is leaking fluids outside of the vascular system. The study     hypothesis is to demonstrate that changes in the optical signals of the non-invasive     monitoring medical device will detect infiltration and extravasation events.   "
138162|NCT01476553|"     A Japanese study showed that the additional use of an Extensive Intraperitoneal Lavage     (EIPL), i.e. an extensive washing of the abdominal cavity with water, during surgery for     gastric cancer can lead to a significant increase in survival. However, the study was     confined to patients in whom upon commencing surgery, free peritoneal tumor cells were     detected, which is only a small fraction of patients.      The primary objective of our study is to assess in all patients undergoing removal of the     stomach and adjacent lymph nodes for stomach cancer, if EIPL can eliminate free peritoneal     tumor cells which have been present at the beginning of the surgery or after the stomach and     lymph node removal. Secondary objectives are to assess how often free peritoneal tumor cells     occur in patients with stomach cancer, how often surgical resection itself leads to a release     of tumor cells, the safety of the EIPL procedure, and disease-free and overall survival of     patients undergoing EIPL. Based on the outcome of this japanese study we want to test with     special laboratory methods why this lavage leads to a better outcome.      Specifically, the trial will test the hypotheses that a) lymph node dissection causes a     release of tumor cells in the abdominal cavity, and b) EIPL eliminates free peritoneal tumor     cells.   "
138186|NCT01476241|"     The investigators main endpoint was focused on the analysis of the type, rate and the impact     of different clinical parameters on the complications of the PEG tube placements performed at     the Department of Otorhinolaryngology - Head and Neck Surgery since October 2008. In     addition, the investigators aimed to compare the results with a historic cohort patient group     (September 2005 - October 2008) sent to the Department of Surgery for PEG tube placement in     order to evaluate the results of the changed routine.   "
138163|NCT01476540|"     Anorexia Nervosa (AN) is a challenging, chronic, refractory illness with the highest     mortality rate of any psychiatric condition. Advances in the neuroimaging, genetics and     neurobiology of AN has led to a greater understanding of its underlying pathophysiology,     although few significant advances in treatment have been made in the last half-century. The     central features of AN, which include an intense fear of gaining weight, a refusal to     maintain a normal weight, as well as significant anxiety, anhedonia and dysphoria surrounding     food, have been linked to dysfunction in key brain structures and circuits. Deep Brain     Stimulation (DBS) is a neurosurgical procedure that involves the insertion of electrodes into     structures believed to drive pathological behavior. The procedure is approved for the     management of movement disorders, such as Parkinson's Disease, and has shown promising early     results in the management of some psychiatric conditions, such as Major Depression. The     purpose of this study is to explore the safety and initial efficacy of DBS, in patients with     treatment resistant AN.   "
138164|NCT01476527|"     Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry.     Although episodes of mania and hypomania define the different types of the disorder, the     clinical picture is one dominated by depressed mood and agitation. The mainstay of BD     treatment has thus far been pharmacologic, but many patients remain severely disabled by     their condition, despite the best available medical treatment. The successful use of deep     brain stimulation (DBS) in movement disorders, and its promising results in major depressive     disorder (MDD), has led researchers to consider its use in highly selected refractory cases     of BD. Evidence form the imaging and circuitry literature suggests that similar underlying     dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key     structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose     a phase I clinical trial to evaluate the safety of DBS in BD.   "
138165|NCT01476514|"     Mutations in genes affecting pain transmission start to be known, the investigators are     investigating a mutation in a glycine channel, which has an influence on pain modulation.     Pain modulation is the ability of the central nervous system to enhance or diminish the     sensation of pain. The investigators therefore will test patients and healthy volunteers with     quantitative sensory tests, basically determining the point at which a stimulation just     starts to induce pain. These tests are reliable and permit a direct comparison between     healthy volunteers and patients with the affected glycine gene.   "
138166|NCT01476501|"     Diabetes is a life-long disease that is getting more common in Canada. One of the most common     problems in people with kidney disease is diabetes and low bone mineral density (BMD). This     can lead to a higher chance for broken bones, infection and life-long health problems. The     most common reason for having low BMD is not getting enough vitamin D (Vit D) in your diet     and not having enough sunlight. This is very common in Canada (especially in northern     Alberta) because winter is very long. Most people also don't eat or drink enough foods that     are high in Vit D (like milk) and so they don't have enough Vit D in their body to make     healthy bones. This can mean the only way to get enough Vit D in your body for your bones     when you have kidney disease is to take some extra vitamin D in a pill. Most people are not     aware that they have poor bone health until they break a bone. Broken bones can really hurt     and can prevent a person from being able to walk and take care of themselves. Right now, we     are not sure exactly how much Vit D people with diabetes and kidney disease need to take to     prevent them from having low BMD or how often they need to take it. Our plan is to study the     effect of two ways to take Vit D pills (every day or once a month) on overall Vit D status     and on bone health in adult patients with diabetes and chronic kidney disease and see how     this influences their quality of life.      Hypotheses:        1. Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result          in significantly improved overall vitamin D status and improved markers of bone health          in adult patients with diabetic nephropathy.        2. Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved          patient adherence and satisfaction with vitamin D supplementation when compared to daily          dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health          parameters, which will result in an increased quality of life and sense of well-being.   "
138167|NCT01476488|"     This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable     pediatric kidney transplant recipients.      Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and     after that, the same dose of advagraf will be prescribed. The patients will have another     pharmacokinetic study of tacrolimus after conversion to advagraf.   "
138168|NCT01476475|"     Primary Objective:        -  The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio          combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as          evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants          treated with metformin.      Secondary Objectives:        -  To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:             -  Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose               and glucose excursions during a standardized meal test;             -  Percentage of participants reaching HbA1c <7% or ≤6.5%;             -  7-point Self-Monitored Plasma Glucose (SMPG) profile;             -  Body weight;             -  Insulin glargine dose             -  Fasting Plasma Glucose (FPG);             -  Percentage of participants requiring rescue therapy during the 24-week open label               treatment period;        -  To assess safety and tolerability of insulin glargine/lixisenatide FRC.   "
138169|NCT01476462|"     Development of a second neoplasm (SMN) during or after therapy for childhood acute     lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In     this international study we analyze subtypes of SMN in relation to their initial leukemia     characteristics and treatment, and their subsequent overall survival.   "
138214|NCT01475877|"     This study will compare the effect of two topical non-steroidal antiinflammatory agents to     control pain after photorefractive keratectomy (PRK) eye surgery.   "
138173|NCT01476410|"     This phase II trial studies how well giving brentuximab vedotin together with combination     chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin     lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block     cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such     as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine     together may kill more cancer cells.   "
138174|NCT01476397|"     This is a growth study of full-term, formula-fed infants randomized to receive a partially     hydrolyzed whey protein formula with and without probiotics for the first four months of     life. It is hypothesized that there will be no difference in growth between the two groups.   "
138239|NCT01475318|"     By using the combination of mifepristone (anti-progestin), misoprostol (progstanglandin which     stimulates uterine contraction), and letrozole (aromatise inhibitor which reduces estrogen     production), the abortion process will be more effective.   "
138175|NCT01476384|"     Aging is accompanied by a progressive loss of skeletal muscle mass and strength, leading to     the loss of functional capacity and an increased risk of developing chronic metabolic     disease. One of these metabolic diseases interacting with muscle mass is Diabetes Mellitus     type 2. Diabetes Mellitus type 2 is characterized by high blood glucose in the context of     insulin resistance and relative insulin deficiency. It has become clear that amongst its many     actions, insulin is also a vasoactive hormone. Its effect to cause endothelial-nitric oxide     dependent vasodilation is physiologic and dose dependent. Recent data suggest that insulin's     metabolic and vascular actions are closely linked. This also means that an increase in     microvascular perfusion following food intake is more resistant to postprandial insulin     release. This physiological process is brought into prominence with increasing age, and even     more in type 2 diabetics, and contributes to diminishing glycaemic control. In the present     study the investigators will investigate the impact of postprandial insulin release on     microvascular recruitment in the oral cavity.   "
138176|NCT01476371|"     The purpose of this study is to determine the effectiveness, with respect to symptoms and     systemic inflammatory level, of mindfulness-based group treatment compared with normal     treatment in patients diagnosed with minor to moderate mental disorders. The hypothesis is     that mindfulness group-treatment 1) will be at least as effective as normal treatment in     reducing psychiatric symptoms; 2) will increase quality of life compared with normal     treatment; 3) will be costeffective compared with normal treatment; and 4) will reduce     inflammation-related markers. The study will be conducted at primary care centers in Skåne,     Sweden. We will assess the effect of mindfulness-based group treatment on psychiatric     symptoms, quality of life, and health (as rated by the patients themselves) as well as     inflammatory markers.   "
138177|NCT01476358|"     Vitamin A supplementation (VAS) significantly reduces all-cause mortality when given after 6     months of age, but has a null or detrimental effect when given between 1-5 months. Studies of     neonatal VAS (NNVAS) have produced conflicting findings. These age-pattern variations might     result from immunological interactions between VAS and vaccines. The potential efficacy of     NNVAS is being retested in 3 large new intervention trials with mortality as endpoint.     Complementary mechanistic studies in animals and in human infants in The Gambia (this     proposal) and Bangladesh have been commissioned to run in parallel.      The investigators will use a 2-arm double blind RCT to test whether NNVAS modulates the early     ontogeny of human immune development. Neonates, recruited through a peri-urban clinic in The     Gambia, will receive either 50,000 International Units (IU) VAS orally within 48 hours of     birth (intervention group, n=100) or a placebo (control group, n=100). Male and female     neonates will be randomized separately at enrolment for later analyses by sex. All infants     will be followed up from birth to age 1 year. A broad panel of immunological outcomes will     examine whether NNVAS: a). normalises thymic development (thymic index by ultrasound); b).     skews mycobacterial and recall antigen responses towards a Th2 profile; c). diminishes Th1     and Th17 reactivity to mycobacterial and recall antigens; d). diminishes the tuberculin skin     test (TST) response; e). causes increased innate immune reactivity; f). increases the     frequency of circulating regulatory T cells (Tregs) expressing gut homing receptors; g).     enhances B cell immune responses after routine vaccination (increase of B cell numbers and     activation status); h). increases circulating IgA in mucosal immune compartment, especially     oral polio vaccine (OPV) specific IgA post-vaccination; i). decreases bacterial     translocation, by improving mucosal barrier function; and j). decreases markers of infection     or inflammation. Growth and morbidity will also be assessed.   "
138178|NCT01476345|"     The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of     LY2963016 compared to those of basal insulin. The study will also gather information on the     safety and tolerability of LY2963016 in healthy participants.      Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout     period). There are 4 study periods.   "
138179|NCT01476332|"     The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics     of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.   "
138180|NCT01476319|"     This study is planning to develop the audiovisual videos and determine whether educational     videos are superior to routine discussion for informing patients in the emergency department     (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy.     Eligible patients will be approached when patients will be scheduled and waiting for     receiving percutaneous cholecystostomy in the emergency department.   "
138181|NCT01476306|"     The investigators will conduct a two-arm, parallel group, randomized comparative     effectiveness study across two sites to increase specialty access and improve care for     individuals with Parkinsonism and their caregivers. Twenty individuals with Parkinsonism will     be recruited from Johns Hopkins University and the University of Rochester (approximately ten     from each site). They will then be randomized to either continue their usual in-person care     with a specialist or to receive care with their specialist via telemedicine in their home.     Following an in-person baseline/screening visit, approximately ten individuals in the first     arm (virtual house calls) will receive three visits with a movement disorder specialist via     telemedicine (using web-based video conferencing) in their home. Approximately ten     individuals in the second (control) arm will receive three in-person visits at an academic     medical center with the same specialists. Approximately two weeks after the completion of     each clinical visit, a nurse or coordinator will call the patient to call to address any     questions or ensure appropriate understanding of the recommendation (for both telemedicine     and control arms). Overall, the study - consistent with a national priority for comparative     effectiveness research - will compare the use of telemedicine to manage Parkinsonism to usual     care.   "
138234|NCT01475383|"     The purpose of this study is to evaluate the safety and efficacy of an investigational     compound designated PF-03654746 compared to placebo in the treatment of adults with     Tourette's Syndrome. The study will also explore the pharmacokinetics of PF-03654746 in     adults with Tourette's Syndrome.   "
138183|NCT01476280|"     Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor     antagonists and this randomized double blind study was designed to compare efficacy of     ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator     hypothesized that palonosetron would have stronger and longer lasting antiemetic effect     compared with ramosetron and evaluated the patients for the first 48 hours after surgery.   "
138184|NCT01476267|"     This single center, open-label, non-randomized, one-treatment, one-period study will evaluate     the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in     male healthy volunteers.   "
138185|NCT01476254|"     The purpose of this study is to describe the magnitude of respiratory complications after     laparoscopic hysterectomy and cholecystectomy.   "
138187|NCT01476228|"     The main objective of the study is to evaluate the use of EEG in the management and follow-up     of neuropsychiatric disorders. Secondary objectives are therefore better understanding of the     pathological activations in neural network during neuropsychiatric disorders, their clinical     evolution and response to therapies.   "
138188|NCT01476215|"     This proof of principle PK study will allow GSKCH to select the most favorable sustained     release formulation among 3 prototypes to move to the next stage of drug development.   "
138189|NCT01476202|"     This study is designed to assess the ability of the mint nicotine mouth strip to relieve     provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.   "
138190|NCT01476189|"     A repeat dose pharmacokinetic study investigating two paracetamol formulations   "
138191|NCT01476176|"     This PK study is designed to show bioequivalence between the study treatments.   "
138192|NCT01476163|"     This program allows physicians to request permission from Amicus Therapeutics (Amicus) for     treatment access to migalastat hydrochloride (HCl) for specific adult patients with Fabry     disease. Treatment is open label for 6 months with renewal every 6 months.   "
138193|NCT01476150|"     1. To establish a BMD reference database of Beijing's urban population, China.        2. To determine the prevalences and risk factors of osteoporosis and osteopenia in          Beijing's urban population, China.        3. To describe the 25OHD level and estimate the prevalence of vitamin D insufficiency and          deficiency of Beijing's urban population, China.        4. Estimation of the prevalence of osteoporotic fracture (vertebral) in over age of 60 of          Beijing's urban population, China.   "
138194|NCT01476137|"     The purpose of this study is to determine whether the MEK inhibitor and the AKT inhibitor can     be given in combination and if the combination is effective treatment for patients with solid     tumors, including breast cancer and endometrial cancer, and for patients with multiple     myeloma.   "
138195|NCT01476124|"     This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or     gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn     alone and in combination as well as the tolerability of morphine administered with GEn. The     dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be     administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a     controlled release formulation of morphine will be given. Blood samples for evaluation of     gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect     of co-administering both treatments will be assessed using visual analog scales for     somnolence/sedation, dizziness and nausea.   "
138196|NCT01476111|"     This study will examine specific biomarkers in primary invasive breast cancer and explore     their correlation with patient outcome following standard neoadjuvant treatment.   "
138197|NCT01476098|"     This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled     capsaicin challenge   "
138198|NCT01476085|"     This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid     ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in     patients with Non Hodgkin's Lymphoma.   "
138199|NCT01476072|"     An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to     obtain a consistent standard of measurement of muscle metabolism while maintaining an     acceptable level of subject comfort and use optimised method to measure and compare     metabolism in the biceps and quadriceps of patients with COPD-related myopathy and control     subjects   "
138200|NCT01476059|"     Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of     children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving     the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose twice a day.      ADERE PROJECT (Pediatric)   "
138201|NCT01476046|"     The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated     after dosing. The study will also investigate how GSK1995057 is taken up, metabolised     (chemically broken down), distributed through the body and excreted, and what some of the     effects of the study drug are.   "
138202|NCT01476033|"     The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice     powder concentrate on oxidative stress, inflammation and blood flow before and post exercise     in overweight, middle-aged, women.      Main hypotheses (H1):        -  The nutraceutical has an impact on oxidative stress reduction.        -  The nutraceutical has an impact on inflammation.        -  The nutraceutical has an impact on blood flow and microcirculation.        -  Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation          markers.        -  Walking exercise for 30 minutes has an impact on blood flow and microcirculation        -  The combination of nutraceutical supplementation + walking exercise for 30 minutes has          an impact on oxidative stress- and inflammation markers, and on blood          flow/microcirculation.   "
138203|NCT01476020|"     The ITALIC PLUS Trial was designed with the objective of extending to other countries the     enrollment of patients into the ITALIC trial initially conducted in France, in order to     achieve statistical significance by pooling the data of both trials.   "
138204|NCT01476007|"     Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin     B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with     Cobalamin Deficiency.      Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary     healthcare setting (Madrid Region).      Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent.     Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system).      Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome     variables: Adverse events. Adherence measurement of treatment. Health related quality of life     questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live     alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical     examination) and blood parameters. Drugs consume.      Causes of all losses and withdrawals. Number of patients (age and gender) who declined to     participate.      All data (excluding patient identification data) will be record in an electronic database.      Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.      Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention     groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence     measurement of treatment.   "
138205|NCT01475994|"     This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to     assess the effect of challenges with dactylis glomerata pollen in an environmental challenge     chamber on dermal symptoms in patients suffering from atopic dermatitis.      After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for     biomarker assessments. The severity of atopic dermatitis will be rated with the SCORing     Atopic Dermatitis (SCORAD), with the objective SCORAD and with the assessment of itch and     sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist) on     each day including baseline assessments.   "
138206|NCT01475981|"     The purpose of this study was to determine the safety, tolerability and pharmacokinetics of     ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy     male subjects.   "
138207|NCT01475968|"     The purpose of this study is to examine the acute health effects of concentrated ambient     ultrafine (UF) particulate matter (PM) exposure in patients with metabolic syndrome. Without     lifestyle changes or medical intervention these patients are at considerable risk for     developing diabetes and cardiovascular disease. Subjects (25-70) were exposed to both UF PM     and filtered air for 2hr (at least 2 week interval), physiologic endpoints were measure pre-,     post-, and 20hr post-exposure. Our hypothesis is that PM exposure in this population will     result in changes in vascular and endothelial response as assessed by flow-mediated     dilatation of the brachial artery and various heart rate variability and blood endpoints.     This study and similar studies of susceptible populations are needed to provide the EPA with     information regarding the health risks associated with ambient levels of UF PM.   "
138208|NCT01475955|"     The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and     effective in the treatment of actinic keratosis when applied to broad areas on the face and     scalp for 1, 2 and 3 hours.   "
138209|NCT01475942|"     The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile     levels of elderly subjects.   "
138210|NCT01475929|"     The purpose of this study is to analyse the effect of probiotic supplement on symptoms of     irritable bowel syndrome.   "
138211|NCT01475916|"     Asthma is the most common chronic disease in childhood [1]. The advantage of an educational     program in a global strategy of care has been established in asthma (decrease of nocturnal     asthma, absence from work and school) [2, 3]. Therapeutic education of the patient permits     the reduction of the rate of hospitalization, of the rate of emergencies visits and     non-programmed visits. [3].      The WHO defines quality of life as an individual's perception of its place in existence, in     the context of culture and value system in which he lives, in relation to its objectives,     expectations, standards and concerns [4]. The basic point of this concept is the notion of     perception, emphasizing the perspective of the person. It is a broad concept affected in a     complex way by the subject's physical health, psychological state, level of independence,     social relationships, and its relations with its environment. In the field of health,     analyzing the quality of life includes objective aspects (living conditions, functional     health) and subjective aspects (satisfaction, happiness, well-being) that allow to understand     the situation of people in whole.      As defined by the WHO-Europe report published in 1996 [5], the therapeutic education aims to     help patients acquire or maintain the competencies they need to best manage their lives with     a chronic disease.      It is entirely part of the management of the patient. It includes organized activities     designed to make patients aware and informed of their disease, of care organization and     hospital procedures, and the behaviors related to health and disease. This is to help them     and their families understand their illness and treatment, to work together and to gain     autonomy from their disease in order to help maintain and improve their quality of life [6].      However, studies demonstrating the effectiveness of therapeutic patient education are still     very few, especially in children. The need for prospective studies including the evaluation     of the impact on quality of life was highlighted in a recent Cochrane meta-analysis [7]. It     seems interesting for the authors to assess the improvement of the quality of life after     educational sessions in children at school-age.   "
138212|NCT01475903|"     Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid     obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two types     of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a purely     restrictive reversible procedure, and gastric bypass (GBP), an irreversible procedure, which     associates restriction and mild malabsorption. Longitudinal sleeve gastrectomy (LSG) is     another bariatric procedure which tends to develop quickly. More recent, this technique is     recognized in France by the High Authority of Health since 2008, consisting of fundus and     greater curvature resection, removing 75 % the gastric volume, leaving a narrow gastric tube     or sleeve.      Although malabsorption does not occur in most bariatric procedures, micronutrient     deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies     concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have minor     effects on normal physiological digestive processes but could lead to vitamin deficiency     secondary to decreased nutrient intake and a tendency towards avoidance of certain types of     food due to intolerance. Studies of nutritional complications of bariatric surgery concern     essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no longer performed in     France. The nutritional impact of LSG remains to be evaluated. To date, data concerning     evaluation of nutritional status from patients who underwent LSG are almost non-existent.     Considering this type of surgical procedure, the investigators expect to observe essentially     a deficiency in vitamin B12 and iron. Indeed, defined as a purely restrictive intervention,     LSG consists of gastric fundus resection which is the site of intrinsic factor production,     itself necessary for vitamin B12 absorption. Moreover, decrease of hydrochloric acid     production and potential vomiting caused by gastric resection can alter iron absorption.      In view of the increasing popularity of this surgical technique, assessment of the     nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.   "
138213|NCT01475890|"     The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in     children, adolescents and young adults with Human Immunodeficiency Virus and acquired     immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind,     placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on     evidence from the Vit D Dose Finding Study-IRB 09-007332.   "
138215|NCT01475864|"     The current standard of care for bile duct stone are endoscopic sphincterotomy and stone     extraction. Placement of plastic stents is an option for incomplete biliary stone clearance.     This study will use the CSEMS in patients with complex biliary stones who failed stone     extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing     measure that allows more successful subsequent stone clearance. However, their use in benign     condition has been limited especially for biliary stone removal. The purpose of this study is     to determine the feasibility, safety, easy removability, stent-stone formation rate, and     migration rate of CSEMS for complex biliary stones.   "
138216|NCT01475851|"     The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with     GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response     to other drugs.   "
138217|NCT01475838|"     This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/     emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative     to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus     Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48     in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety,     tolerability, and efficacy of the two regimens through 96 weeks of treatment.   "
138218|NCT01475825|"     Primary objective:      Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in     patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as     low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary     heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of     CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different mipomersen     dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly versus     placebo, and SC mipomersen 70 mg thrice weekly versus placebo.      Secondary Objectives:        -  Determine whether there are qualitative differences between the safety profiles of the 2          dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160 mg/dL          and <200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort 2), and          the overall study population        -  Determine whether there are qualitative differences between the tolerability of the 2          dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population        -  Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1,          Cohort 2, and the overall study population        -  Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic          lipid levels in Cohort 2 compared to placebo        -  Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients          with FH and inadequately controlled LDL-C who complete the primary efficacy assessment          visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label          Continuation Period   "
138219|NCT01475812|"     Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow     limitation usually progressive and associated with inflammatory response of lung noxious     particles. During a physical activity chronic obstructive pulmonary disease patients may     develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased activity     performance. The investigators hypothesize that some specific activities of daily living     induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure dynamic lung     hyperinflation and its influence in dyspnea perception in moderate and severe chronic     obstructive pulmonary disease patients after activities of daily living. Methods: The     investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen saturation,     heart rate and respiratory rate in 19 chronic obstructive pulmonary disease (COPD) patients.     These measurements were taken at rest and after daily living activities (such as going up and     down a set of stairs, going up and down a ramp and sweeping and mopping a room).   "
138220|NCT01475565|"     The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with     PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy     complications. It is unknown if there are factors that may predict which women are more at     risk.      The goal of this study is to evaluate the risk factors of gestational diabetes, such as     dietary and physical activity factors, race, and how the body handles its own hormones during     pregnancy. Our long term goal is to contribute in finding ways to successfully prevent     gestational diabetes.   "
138221|NCT01475552|"     The researchers aimed to investigate the effect of point-of-care platelet function assay on     the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.      All patients who are supposed to undergo coronary angiography were loaded with clopidogrel     (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent     after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP     (Accumetrics). If patients have >270 unit in the assay, they are randomized to abciximab or     control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are     followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are     assessed at 1 month.   "
138222|NCT01475539|"     The purpose of this study is to generate data to support the registration extension of IMOVAX     Polio to be used in a sequential vaccination.      Primary objective:        -  To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral          Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2)          poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of          seroprotection rate 28 to 42 days after the third dose of the primary vaccination          series.      Secondary objectives:        -  To evaluate the safety profile of the investigational vaccines after each administration          in each group.        -  To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3)          before the first dose and 28 to 42 days after the third primary series dose of vaccine          in each group.        -  To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and          3) after the third primary series dose administration, at 18 months of age in each          group.   "
138235|NCT01475370|"     The purpose of this study is to assess the safety of OCV-501 in patients with AML who     completed the Study 311-10-001 and were judged that there was no relapse by any inspections     in the end of the study.   "
138475|NCT01472328|"     Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin     sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.   "
138223|NCT01475526|"     El Valor de Nuestra Salud [The Value of Our Health] is a 5-year study (2010-2014) involving     grocery stores in San Diego County funded by the National Cancer Institute. The purpose of     the study is to determine whether an in-store program can promote healthy foods through     grocery stores. Sixteen stores in San Diego County will participate in El Valor de Nuestra     Salud. The stores that participate in this study will be randomly assigned to either the     intervention (program and evaluation) or control (evaluation only) group. We will test     various strategies to promote healthy food shopping among customers of small-to-medium size     Latino/Hispanic grocery stores. These strategies include changes to the store environment,     food marketing efforts, and training of sales associates. Our evaluation protocol will     determine whether the project is successful at improving aspects of the store and the     employees, as well as whether customers shop for and eat healthier food products. The primary     aim of the study is to evaluate the impact of the El Valor de Nuestra Salud intervention on     consumption of fruits and vegetables among store customers.   "
138224|NCT01475513|"     Birth control pills are the most commonly used method of birth control. The purpose of this     research study is to examine whether birth control pills change heart disease risk and how     the body handles blood sugar when given to different women.   "
138225|NCT01475500|"     This screening study will address the lack of molecular strategies for the early detection of     lung cancer and integrate those with epidemiological and imaging strategies.      The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular     analysis of biological specimens including those from bronchoscopy (bronchial brushings and     biopsies) may contribute to the refinement of high-risk populations and allow an earlier     clinical diagnosis.      The goal of the investigators study is to provide screening for lung cancer in a high-risk     population. In this prospective cohort it will be tested whether repeated measure of     biomarkers of risk allows early detection of lung cancer.   "
138226|NCT01475487|"     Inability to provide oxygen to the patient remains the most fearful anesthesia-related     mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an     anesthesiologist, who is encountered with this situation. The current method of     cricothyrotomy relies on digital palpation (DP). Several patient populations, including     morbidly obese, short neck, radiation to and previous neck surgeries, have difficult     landmarks for this procedure. Ultrasound (US) technology has been used in the past to     visualize landmarks for cricothyrotomy, but there is no study which has examined the role of     ultrasound in patients who have obscure landmarks. There is no data related to the     performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed to     determine the outcomes of CT performed on human cadavers using US-guidance, compared to     conventional DP, of anatomical landmarks. In particularly, complication rates, failure to     cannulate, correct placement of the device and insertion time of CT were assessed.   "
138227|NCT01475474|"     The purpose of this study is to determine whether the use of the Renew Insert is effective,     tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.   "
138228|NCT01475461|"     B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2     diabetes   "
138229|NCT01475448|"     The goal of this project is to understand the effect of regular practice of long distance     running on the posture and movement control of older adults.      For such, the investigators will conduct an experiment with longitudinal design where     sedentary elderly individuals will be trained in long distance running for about 4 months.   "
138230|NCT01475435|"     Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders     that have a major impact on the health and well being of millions of individuals worldwide.     Periodontal diseases are among the most common diseases in humans, therefore, if the presence     of periodontal diseases plays any role in overall systemic health, the public health impact     may be substantial. An important factor that can be involved in the progression of the     periodontal disease is the production of Reactive Oxygen Species (ROS). The imbalance between     oxidative stress induced by ROS and the concentrations (or activity) of the antioxidant may     result in tissue damage. The ROS induce the activity of lipid peroxidation-Tbars,     myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect the severity of the     periodontal disease and it may offer the basis for a patient specific diagnostic test for     periodontitis and could have therapeutic significance. The aim of this study is to     investigate quantitatively the levels of oxidative stress markers (Myeloperoxidase,     Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival crevicular fluid (GCF)     of diabetes type 2 subjects with generalized chronic periodontitis and periodontally healthy     individuals, and systematically healthy individuals with generalized chronic periodontitis     and periodontally healthy individuals, before and after periodontal treatment. Unstimulated     whole saliva will be collected for 5 min as well as GCF of 25 diabetes type 2 with     generalized chronic periodontitis, 25 diabetes type 2 periodontally healthy individuals as     controls, 25 systematically healthy individuals with generalized chronic periodontitis and 25     periodontally healthy individuals before and after treatment. The following clinical     parameters will be evaluated: probing pocket depth, probing attachment level, plaque index     and the gingival index. The activity of stress markers in saliva and GFC will be analyzed by     spectrophotometry. Adequate statistical analysis will be carried out with a p-value set at p     < 0.05.   "
138231|NCT01475422|"     The self-monitoring of capillary blood glucose is part of the package of interventions in     diabetes mellitus and an effective therapeutic strategy for the adequate control of the     disease; and the continuing education of people with DM is recognized as one of the goals to     delay the complications arising from chronic disease and alleviate the symptoms of     hypoglycemia and hyperglycemia.   "
138232|NCT01475409|"     The screening for latent tuberculosis infection (LTBI) prior to the onset of anti-tumor     necrosis factor therapy, as well as a watchful monitoring during the treatment, is strongly     recommended. Tuberculin skin test (TST), universally used for this purpose, lacks sensitivity     and specificity. The novel screening tools, including QuantiFERON-TB Gold In-Tube (QFT-GIT),     have shown a higher specificity compared to TST, but their feasibility in the setting of     immunosuppression remains unclear. Aims of this study were to investigate the performance of     QFT-GIT and its agreement with TST in patients awaiting anti-tumor necrosis factor (TNF)     therapy, and to evaluate the usefulness of serial QFT-GIT during the treatment with biologics     to assess whether dynamic changes in interferon (IFN)-gamma levels may be helpful in     identifying reactivation of LTBI or cases of newly acquired tuberculosis.   "
138233|NCT01475396|"     Physical activity is thought to increase overall body functions and to decrease     cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise     could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80     years old healthy subjects take part in a prospective study with regular sports activity     during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome     measures, further investigations include MRT of the head, lactat- and other physical measures     as well as detailed serum profiles. As a hypothesis, enhanced physical activity is suggested     to predict better cognitive performance.   "
138236|NCT01475357|"     Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to     address a widespread health problem in the pediatric cardiac infant population - poor     postnatal growth - through a collaborative effort between pediatric cardiology,     cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that     term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk     feeds in the pre-operative period will show improved gut function than neonates who were     strictly NPO (nothing by mouth) in the pre-operative period.   "
138237|NCT01475344|"     Severe traumatized patients with visible significant bleeding and/or with clinical signs of     internal significant bleeding treated by an emergency doctor of the helicopter service or the     ground team will be enrolled in the study (inclusion- and exclusion criteria: see above). If     a patient meets the inclusion criteria and is recruited for the study, FGTW or placebo     administrated over 5 min/vial:      Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg      No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)      Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g   "
138238|NCT01475331|"     The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or     without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic     ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.   "
138240|NCT01475305|"     The primary objective is to evaluate the suitability of the challenge model in measuring the     efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in     the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.   "
138241|NCT01475292|"     RV568 is being developed as a possible treatment of diseases such as smoking related lung     disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma.      The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose     strengths of RV568 and a placebo will be tested in this study, which will be given by     inhaling a liquid suspension from a nebuliser once a day for 2 weeks.   "
138242|NCT01475279|"     The purpose of this study is to evaluate the potential effect of Dantonic on the steady-state     pharmacodynamics and pharmacokinetic of warfarin in healthy subjects and safety of the     co-administration of Dantonic and warfarin.   "
138243|NCT01475266|"     The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle     invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were     randomized into either an EO9 or placebo group after TURBT.   "
138244|NCT01475253|"     The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system,     is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into     the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via     cystoscopy.   "
138245|NCT01475240|"     Use of some protease inhibitors is associated with elevations of a blood pigment called     bilirubin. This may occasionally lead to yellowing of the eyes (scleral icterus) or jaundice,     but in the general population bilirubin elevations have been shown to have antioxidant and     anti-inflammatory properties that could be associated with reduced risk of cardiovascular or     other disease events.      Inflammation may also be relevant to neurocognitive impairment in HIV (Human Immunodeficiency     Virus) infection hence elevations of bilirubin may also be protective against neurocognitive     impairment.      The purpose of this study is to evaluate the impact of hyperbilirubinemia (HBR) on risk of     heart and renal diseases, and cognitive function.   "
138246|NCT01475227|"     The study is being conducted as the most common side effect of the HIV drug atazanavir (taken     with ritonavir) is hyperbilirubinaemia. Bilirubin is a normal waste product from the body and     gets broken down in the liver so it can leave the body through the gut. Atazanavir slows the     breakdown of this chemical, which can cause jaundice (yellowing of the skin) and/or scleral     icterus (yellowing of the eyes). This is completely harmless; in fact up to 1 in 10 of the UK     population have an inherited condition that causes the same yellowing. However, some patients     don't like this side effect and it is the commonest reason for switching off the drug.      A study in people with Gilberts syndrome (the inherited condition that causes the same     changes in the chemical bilirubin) showed that a mineral supplement (zinc sulphate) reduced     the levels of bilirubin in the blood. The aim of this study is to see if using zinc     supplements can achieve the same effect in patients with high bilirubin due to atazanavir     use.   "
138247|NCT01475214|"     With aging, men and women develop a mild and progressive metabolic acidosis. This occurs as a     result of declining renal function and ingestion of acid-producing diets. There is extensive     evidence that severe metabolic acidosis causes bone and muscle loss, but the impact of the     chronic, mild acidosis on bone and muscle in older individuals has not been established. In a     recent study, administration of a single dose of bicarbonate daily for 3 months significantly     reduced urinary excretion of N-telopeptide (NTX), a marker of bone resorption and urinary     nitrogen, a marker of muscle wasting and improved muscle performance in the women but not the     men. These and other data support a potential role for bicarbonate as a means of reducing the     musculoskeletal declines that lead to extensive morbidity and mortality in the elderly.     Before proceeding to a long-term bicarbonate intervention study, however, it is important to     identify the dose of bicarbonate most likely to be optimal and to characterize the subjects     who benefit most from it. This double blind, placebo controlled, dose-finding study will     evaluate the effects of placebo and two doses of bicarbonate on urinary NTX and nitrogen     excretion and on lower extremity performance over a 3 month period in 138 men and 138 women,     age 60 and older. Changes in urinary excretion of NTX and nitrogen and in selected measures     of lower extremity performance will be compared across the three groups. The safety and     tolerability of the interventions will also be evaluated. This investigation should provide     needed information on the appropriate dosing regimen for men and women and on the study     population that should be enrolled in a future bicarbonate intervention trial to assess the     long-term effects of this simple, low cost intervention on important clinical outcomes     including rates of loss in bone and muscle mass, falls, and fractures.   "
138265|NCT01474980|"     This is a retrospective study that follows the clinical evolution, the pregnancy and the     post-partum perioad of female patients with Congenital Myasthenic Syndrome.   "
138266|NCT01474967|"     Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and     causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by     insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this     study was to assess the effects of metformin on menstrual disorders and lipid profile in     women with PCOS in bandarabbas.   "
138248|NCT01475201|"     Many people with diabetes and/or high blood pressure (hypertension) are not very active. When     people are more active, they can reduce the chances of having a heart attack or stroke.     Walking more is a cheap and effective way to be more active and to lower the risk of heart     attacks and strokes. The problem is that many people do not walk enough! The investigators     will study if people with diabetes and/or hypertension walk more when the doctor gives them a     prescription with the number of steps they should be walking every day. The investigators     will compare this group, called 'active', to another group, called 'control', in which     doctors and their patients do what they usually do, over a period of one year.      The investigators will measure the number of steps the investigators walk everyday with a     step counter or pedometer. In the step count prescription group, the doctors will give to the     'active' group a pedometer, a step count record book, and step count prescriptions. The     overall goal is to gradually increase daily steps. The speed of the increase in step count     will be slower for less active people. At each visit the doctor will look at the step count     record book. The doctor will then give a new step count prescription to the patients.     Patients of the two groups will see their doctor about four times during the year, which is     how often they usually see their doctor. At the end of one year, the investigators will see     the difference in the hardness of the arteries between the 'active' and the 'control' groups,     using simple and safe measurements, similar to ultrasound in pregnant ladies. People with     hard arteries are more likely to have a heart attack or stroke.      The investigators suspect that patients who get the step count prescriptions will walk more     and their arteries will be less hard than the control group. Our study will help find out if     this is true. In that case, doctors should take the time to prescribe steps for all their     patients with diabetes and/or hypertension.   "
138249|NCT01475188|"     The purpose of this study is to determine whether specific subcutaneous immunotherapy affects     fractions of regulatory T lymphocytes and histamine H2 receptor expression and ZAP70 in     regulatory T lymphocytes.   "
138250|NCT01475175|"     The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective,     multi-center, non-randomized investigational study designed to compare indices of cardiac     function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm     versus nominal programming. The comparison will be performed during rest, atrial pacing and     sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being     conducted in Europe.   "
138252|NCT01475149|"     This 12 week study will observe patients with and without systemic lupus erythematosus who     have persistent antiphospholipid antibodies in the blood who are starting a medicine called     hydroxychloroquine. It will measure if these patients have a change in a blood test called     the annexin A5 resistance assay over that 12 week period.   "
138253|NCT01475136|"     This study will explore how liver impairment effects blood levels of LY2140023 (a prodrug)     and its active metabolite LY404039.   "
138254|NCT01475123|"     Nicorandil is potentially effective to prevent cardiovascular events in patients with     coronary artery disease (CAD) receiving hemodialysis. The purpose of this study is to     prospectively investigate whether nicorandil is effective in reducing the incidence of     cardiovascular events in patients with CAD on hemodialysis.   "
138256|NCT01475097|"     The purpose of this study is to evaluate and compare overall patient comfort profile between     an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media     (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.   "
138257|NCT01475084|"     The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid     thoracoscopy.   "
138258|NCT01475071|"     The main objective of this study is to compare efficacy and safety of Metvix® natural     daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with     Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).   "
138259|NCT01475058|"     This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor     T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients     who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B     cell malignancy.   "
138260|NCT01475045|"     The aim of the study is to compare patients' satisfaction from the use of three different     inhalation devices by using the FSI-10 questionnaire   "
138261|NCT01475032|"     The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler     (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP)     and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung     functions in asthmatic children patients.   "
138262|NCT01475019|"     The first aim of the investigators study, was to investigate the combined effect of     diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH)     levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.      The other aim of the investigators study, was to examine the effect of hypocaloric     diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and     metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).   "
138263|NCT01475006|"     This is an open-label, sequential dose exploration study of single agent AMG 595 administered     in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA).     The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of     AMG 595, and also to evaluate the objective response rate in subjects receiving AMG 595. This     study will be conducted in two parts. Part 1 will explore doses of AMG 595 in subjects with     recurrent GBM and/or AA. Part 2 (dose expansion) will examine the MTD established in Part 1     in subjects with recurrent GBM.   "
138264|NCT01474993|"     The primary objectives of this study are to answer whether there is evidence of measurable     effects on social responsiveness (primary outcome) and other behavioral symptoms after     treatment of autistic male adolescents and adults with orally administered sulforaphane-rich     Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer     whether treatment of male adolescents and adults with autism using orally administered     sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity);     treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and     adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of     principle).   "
138267|NCT01474954|"     This is a single-site substudy, Investigation of the Effect of Cenicriviroc (CVC) plus     Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors, open to all patients     enrolled in the primary study, A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of     100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With     Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With     Only CCR5-Tropic Virus, in the San Francisco Bay area to evaluate changes in brachial flow     mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at     100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV)     matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1     tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS     + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS     + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50     patients of the 150 total enrolled in the primary study will be referred to and enrolled in     the cardiovascular substudy.      Patients enrolled in the substudy and substudy protocol staff will be blinded to study     treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory     data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary     study.      The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in     approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients     will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus <100,000     copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive     all medications from the primary study, and thus the primary study site will be responsible     for any adverse outcomes with the drug.   "
138268|NCT01474941|"     The primary purpose of this trial is to evaluate the safety and tolerability,     pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04620110 as a     modified-release formulation.   "
138269|NCT01474928|"     In this study, the investigators aim to develop and test the effectiveness of culturally     appropriate asthma videos and other educational materials based on knowledge from this study     and the investigators' previous studies. By culturally appropriate materials the     investigators mean to develop health information (in the format of video and written     materials) in the community own language and applied the most appealing cultural beliefs and     practices in the Chinese and Punjabi communities. The investigators also aim to recommend a     practical framework and to develop a measure of asthma knowledge and health literacy among     immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of     health literacy in this study is the capability of a person to navigate and access to     asthma-related information, as well as to understand, evaluate, and communicate the obtained     information to improve his/her health status. The investigators' hypothesis is that     audio-visual based asthma information in a subject's native language would improve a     patient's knowledge and self-management of asthma in comparison to printed information.   "
138270|NCT01474915|"     This study is being done to determine the efficacies of two preventative drug combinations     for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this     study is to compare the efficacy of using aprepitant instead of ondansetron in combination     with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By     completing this comparison study investigators will determine the most efficacious drug     combination which will allow us to enhance the overall comfort and satisfaction of     neurosurgical patients in the immediate postoperative period.   "
138271|NCT01474902|"     The CATCH-enoxaparin trial is the natural continuation of the CATCH study. It will capitalize     on the fact that patients enrolled in the CATCH study will be specifically screened for     asymptomatic thromboembolism (TEs) in order to answer important clinical questions.      The investigators propose a randomized controlled trial to address whether, among pediatric     patients with congenital heart defects (CHD) recovering from cardiovascular surgery and     diagnosed with an asymptomatic venous TE, the use of enoxaparin results in a net therapeutic     benefit?   "
138272|NCT01474889|"     The Investigator is in the final phase of this study and is searching for a Hypo-AWARE Type 1     diabetic control group (Group 2). The primary goal for Group 2 in this study; is to     demonstrate how hormones of Type 1 diabetics should react during hypoglycemic and     non-hypoglycemic events.      Enrollment for Group 1 (Hypo-Unaware) and Group 3 (Non-diabetic) is complete.      This study is designed to determine if real-time continuous glucose monitor (RT-CGM) can     reverse defective Glucose counter regulation and hypoglycemia unawareness in long standing     type 1 diabetes.   "
138273|NCT01474876|"     This 12-month postmarketing observational study (PMOS) was a prospective, single-arm,     multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the     initial baseline visit. The study was conducted to determine the long-term effectiveness of     treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis     (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.   "
138274|NCT01474863|"     This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate     biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to     placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis     is that intravenous L-citrulline will decreased the development or progression of acute lung     injury in patients with severe sepsis compared to placebo.   "
138275|NCT01474850|"     The aim of this study is to examine chest wall volume changes monitored by opto-electronic     plethysmography during recovery from anesthesia and early postoperative period.   "
138276|NCT01474837|"     Exercise as an adjunct to routine treatment may be useful for helping young people recover     from distressing mental health problems, but they seldom get sufficient support to help them     to exercise. The reasons for this may be that services cannot agree on the benefits of     exercise, and the lack of reliable evidence showing the benefits of exercise in young people     who use mental health services. Compliance with prescribed exercise is generally low, but the     investigators think that relatively few young people will drop out of our specially designed     programme. The investigators have found that young 'healthy' people may respond better if     exercise is matched to their ability. The investigators are not sure if this would work with     young people with mental health difficulties, so the investigators want to test it. The     investigators have also found that our enabling exercise plan, with social support and     motivational coaching, helps people with depression to take part, and not to drop out. The     aims of our study are to see if exercise matched to their ability, with support in taking     part, helps young people recover from distressing mental health difficulties. The     investigators also want to ask young people how they feel about exercise as a part of their     recovery. The investigators want to see if motivational coaching can help ongoing     participation in exercise, and the investigators want to follow up the young people after six     months to see if they are still doing exercise. The investigators believe that this study is     important because it will help young people feel better about themselves, and improve their     quality of life. This is an important national public health goal and should enable young     people to grow into healthy adults, and maintain their health throughout adulthood. If our     study is successful, the investigators believe that it has the potential to change the way in     which mental health services deliver care to young people. If the investigators can help     young people feel better about themselves, and improve their general health and well being     through exercise, the investigators may reduce their reliance on mental health services.      Research hypotheses A tailored exercise intervention will lead to significantly improved     mental health outcomes and reduced exercise attrition rates in young people with depression.   "
138296|NCT01474577|"     The physician would like to see if nuclear cardiac stress tests can predict cardiac health.     For example, if a patient has an abnormal stress test, is he or she more likely to have     cardiac problems in the future?   "
138277|NCT01474824|"     Measurement of how much blood the heart pumps may be useful in guiding how much intravenous     fluid to give patients during surgery. The current monitors either require special drips     (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which may     limit their use. Newer monitors are available which are completely non-invasive and seem to     work well in younger patients. Patients with hip fracture are elderly and frail. The     investigators wish to see whether the newer non-invasive monitor works well enough compared     to the current monitors in this group of patients. If it does this may allow more of these     patients to be monitored in this way.   "
138278|NCT01474811|"     The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients     undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic     and community practices.   "
138279|NCT01474798|"     This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in     subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via     subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of     3 injections. Study drug will be administered under close observation in a facility equipped     to handle medical emergencies. Subjects will not be discharged from the facility until at     least 1 hour following the injection or 1 hour after their vital signs have stabilized.     Safety will be assessed by pre- and post-treatment serial measurements of vital signs,     clinical laboratory assessments, and the recording of adverse clinical events.   "
138280|NCT01474785|"     The purpose of this study is to determine if interruption in gastric-adipose tissue axis     signaling contributes to early improvements in oxidative stress, insulin sensitivity, and     inflammation, and to determine if interruption of the stomach in RYGB results in reduction of     plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG)     ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.   "
138281|NCT01474772|"     The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy     (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates     improvement relative to placebo on the following: reducing DPN pain, reducing pain on     walking, and providing other benefits associated with daily activities and quality of life.   "
138629|NCT01470209|"     This study will assess the safety of combining two agents (everolimus and BKM120) for the     treatment of advanced cancer arising from solid organ in patients who are no longer     benefiting from or unable to withstand standard treatment of these conditions.   "
138282|NCT01474759|"     The primary aim of this research is to determine the efficacy of two portion-control     strategies to achieve sustainable dietary and behavior changes and to promote weight loss and     maintenance. A randomized controlled trial will test two approaches to managing portion     sizes: one that gives individuals skills and tools to help them make appropriate portion     choices, and another that focuses on consumption of pre-portioned foods in order to limit     exposure to large portions in the personal food environment. A third group will receive a     basic nutritional program to promote weight loss.      The second aim of the research is to determine the effects of the programs on knowledge and     consumption of appropriate portions, as assessed by innovative assessment methods and     multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual     factors that may influence the response to the portion-control interventions, such as     psychosocial indicators, blood biomarkers, and measures of adherence to the interventions.     The expected outcome of the project is that it will lead to the development of specific,     evidence-based strategies to help control portion sizes in order to manage weight.   "
138283|NCT01474746|"     This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2     years to 5 years 8 months old. The trial is six months long, and each participant will     receive a series of tests at both the beginning and end of the study. The researchers hope to     show improvements in language and a decrease in autistic symptoms.   "
138284|NCT01474733|"     1. Briefly describe the purpose of this protocol: This study is designed to evaluate the          effectiveness of an educational training program on the topic of health literacy for          Family Medicine residents. The hypothesis being tested is that training residents about          health literacy will result in improvements in residents' knowledge, skills, and          attitudes with respect to health literacy.        2. Briefly summarize how participants are recruited: OHSU Family Medicine Interns attending          mandatory trainings on the topic of health literacy throughout the three years of the          residency program will be invited to participate in the study.        3. Briefly describe the procedures subjects will undergo: Completion of a short          self-administered anonymous survey before and after a variety of learning sessions on          the topic of health literacy.        4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test          questionnaire and 13-item post-test questionnaire designed to assess individuals'          knowledge about health literacy, and intended clinical practices with respect to health          literacy.        5. If this is a clinical trial using an experimental drug and/or device, or an approved          drug and/or device used for an unapproved purpose, briefly describe the drug and/or          device: n/a        6. Briefly describe how the data will be analyzed to address the purpose of the protocol:          Demographics and responses to individual items will be reported as frequencies and          percentages within the sample. We will use a chi-square analysis to stratify responses          by demographic groups and t-tests to measure possible changes over time   "
138285|NCT01474720|"     Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for     the development of shingles, a painful reactivation of the varicella zoster virus that causes     chicken pox.      The investigators propose to study the immune response to commercially available Zostavax     vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and     are on mild immunosuppressant medications, and to compare the immune response to that seen in     healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the     study are those felt to be safe according to Centers for Disease Control guidelines.      Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to     receive a single, standard dose of Zostavax. Blood samples and physical examination will be     performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants     will receive active vaccine, there is no placebo group.   "
138329|NCT01474148|"     The purpose of this study is to evaluate a surgically implanted functional electrical     stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying     small electric currents to the nerves, which cause the muscles to contract. This study     evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord     injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.   "
138286|NCT01474707|"     Goal: The main goal of this study is to develop and validate educational materials that aim     to improve self-management knowledge and practices about COPD among patients in Mandarin and     Cantonese-speaking communities in the Greater Vancouver Area (GVA).      Objectives: 1. To assess the current landscape of COPD beliefs, perceptions and practices,     as well as health literacy as it relates to Chinese Mandarin and Cantonese-speaking patients;     2. To develop effective partnerships within primary care physicians serving Chinese     newcomers in the GVA' 3. To conduct focus group sessions with collaborative primary care     physicians to identify common factors that contribute to under service and access barriers     among patients in the target communities; 4. To assess the effectiveness of the educational     materials on patients' beliefs, perceptions, practices, and health literacy related to COPD     control and self-management; and 5. To improve the capacity of physicians and allied health     workers in primary care settings in educating patients and their families about     self-management of COPD.      The implementation of the project will include the following phases: 1. Build and     strengthen established partnerships with primary care practices serving newcomers in GVA;     2. Conduct an environmental scan and needs assessment (literature review, interviews and     focus groups with community members and key-informants); 3. Development of story scripts,     video clips and other educational materials, and relevant measurement tools; 4. Application     of the video clips and other educational materials to test their effectiveness on health     literacy, beliefs, and knowledge among COPD patients from the target communities; and 5.     Evaluation of the usefulness of videos and other educational materials, and the project's     process and outcomes.   "
138287|NCT01474694|"     Preoperative image-guided data correlates with the actual intraoperative reality.     Computer-assisted preoperative planning combined with intraoperative mapping of even very     small lesions allows for improved accuracy during complete oncological resection / ablation.     In the short- and long-term this possibly results in better patient outcome.   "
138288|NCT01474681|"     This study evaluated the safety and tolerability of using HSC835 in patients with     hematological malignancies.   "
138291|NCT01474642|"     Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response     rates, which is most commonly used to treat patients with metastatic, recurrent or locally     advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose     schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day     continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are     inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug     of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III     trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in     the first-line metastatic setting but also in the adjuvant setting. In the investigators     experience, capecitabine plus cisplatin combination (XP) as a first-line treatment for 45     patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a     promising anti-tumor activity with 57% of response rate and showed tolerable toxicity with     convenience.      Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in     patients with advanced esophageal cancer. A Dutch phase II study demonstrated that paclitaxel     combination with carboplatin had shown an encouraging confirmed response rate of 59% with 51     patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch phase II     study showed 43% of response rate including 4% of CR with 8 months of response duration when     paclitaxel plus cisplatin administration was given for patients with metastatic esophageal     cancer. Although recently first-line palliative chemotherapy regimen in esophageal cancer has     been investigated, many trials have failed to show superiority to 5-FU/cisplatin combination.     Since the investigators considered that XP or XG (genexol) is more effective and convenient     chemotherapy regimen than 5-FU/cisplatin, this randomized phase II study was planned to     compare XP with XG in terms of efficacy and tolerability.   "
138292|NCT01474629|"     We investigate the impact of a probiotic-based dietary supplement on oxidative stress and     endotoxemia before and after strenuous exercise.      Hypotheses (H1):        -  Supplementation has an influence on oxidative stress parameters before and post exercise        -  Supplementation has an influence on parameters of endotoxemia and inflammation before          and post exercise        -  Strenuous exercise has an influence on parameters of oxidative stress, inflammation and          endotoxemia   "
138293|NCT01474616|"     Almost 90 percent of residents living in long-term care facilities have some type of mobility     limitation, which worsens quickly once they move into a long-term care facility. This means     that they cannot easily walk or move around in their day-to-day lives and this can have     serious consequences for their general health and well-being. Researchers have shown that     exercise can help the mobility of even the oldest of adults but elderly residents in     long-term care facilities still commonly sit or lie in bed for long periods of time, in many     cases for most of their waking hours. The purpose of this research is to study the effect of     a simple physical activity on the mobility and quality of life of residents in long-term care     facilities. Researchers will introduce a sit-to-stand activity to health care aides which     will become part of their daily routine with residents. The basic sit-to-stand movement is     already a part of the daily activities that health care aides do with residents.     Specifically, health care aides will ask residents to repeat the sit-to-stand activity at     mealtimes, when using the toilet, and on other occasions of daily activity. An important part     of this research is to find out how well the activity preserves the ability of residents to     stay mobile and also to examine how this will improve their quality of life in the home. The     MOVE study will demonstrate whether it is possible to delay the loss of mobility in long-term     care residents by incorporating the sit-to-stand activity into the regular practice of health     care aides.   "
138294|NCT01474603|"     Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are     crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous     study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose     tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the     investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched     diet with low glycemic index to overweight and obese patients with insulin resistance,     prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are     changes from baseline in HbA1c and body weight for for type 2 diabetes and all other     patients, respectively.   "
138295|NCT01474590|"     Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group     comparison study in subjects with severe acne vulgaris on the face.   "
138297|NCT01474564|"     The purpose of this study is to collect blood samples and study cancer cells found in these     blood samples from patients with pancreatic cancer. Prior research has discovered that tumor     cells can be collected from the blood of patients with pancreatic and other cancers.      The physicians have developed techniques for isolating and analyzing cancer cells using a     simple blood test. They will study how these cells relate to how chemotherapy works. They     hope to use this information to guide choices of treatment for patients in the future.   "
138298|NCT01474551|"     The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on     the patient and the melanoma. Specifically, the investigators want to know how well     vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib     can improve how well the patient functions.   "
138299|NCT01474538|"     This study will provide information on the use of insulin lispro and insulin aspart in     insulin pumps in participants with type 2 diabetes.   "
138300|NCT01474525|"     This Randomized Controlled Trial (RCT) will test the efficacy of a home blood glucose     telemonitoring system against usual care in women with gestational diabetes mellitus (GDM) or     type 2 diabetes mellitus (T2DM) during pregnancy. We hypothesize that the system can improve     glycemic control in patients, assessed using the mean blood glucose during gestation as the     primary outcome measure.   "
138301|NCT01474512|"     This study will assess the safety and efficacy of LY2439821 compared to placebo in     participants with moderate to severe, chronic plaque psoriasis.   "
138302|NCT01474499|"     This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol     rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients     with constipation.   "
138303|NCT01474486|"     The purpose of this project is to conduct a preliminary test of the feasibility of a     multi-micronutrient intervention to improve micronutrient status, cardiac function and     quality of life in Veterans with Congestive Heart Failure (CHF).   "
138317|NCT01474304|"     Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease     opioid requirements over the first 12 hours of postoperative recovery following craniotomy.     Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use     hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.   "
138318|NCT01474291|"     This prospective, multi-center, observational study will evaluate factors influencing the use     of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real     life setting. Data will be collected from participants for 12 months following initiation of     tocilizumab treatment.   "
138304|NCT01474473|"     CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates.     Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells,     known as extracellular matrix, by binding to structural proteins, and 2) in the cell     communication by protecting growth factors. At the site of a lesion, glycosaminoglycans are     degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By     replacing damaged glycosaminoglycans, CACIPLIQ20 provides a protective function and restores     the matrix architecture and the cell communication, a process known as Matrix Therapy.      As for now, three non-controlled pilot studies have been carried out on small populations.     They have shown a substantial enhancement of chronic wounds state after treatment with     CACIPLIQ20. Therefore, the purpose of this new controlled study is to determine whether     CACIPLIQ20 can shorten diabetic neuropathic plantar ulcers healing when the off-loading is     mandatory.      The study's main hypothesis is that CACIPLIQ20 application on a non-healing diabetic plantar     ulcer in an off-loading mandatory context would reinitiate the natural process of tissue     regeneration and lead to total wound closure faster than following standard wound care.   "
138305|NCT01474460|"     Background: Warfarin is used as an anti-coagulant in patients at risk of developing     thrombosis. It has a narrow therapeutic index necessitating close monitoring of International     Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only     63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective     and prospective studies have looked at supplementation with phytonadione in these patients to     reduce the variability of INR showing an improvement in variability. Most of these studies     have only been done in a small number of patients already on warfarin therapy. This study     will focus on patients newly starting warfarin therapy.      Methods: This study is a prospective, randomized, controlled trial performed at James A.     Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will     receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for     80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants     will be randomized to either intervention or control. Intervention group participants will be     prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth     daily. Control group participants will be prescribed their usual starting dose of warfarin.     Both groups will follow the usual standard of care. They will come in for a follow-up INR and     warfarin dose titration at least once per week until therapeutic, and then as instructed up     to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic     activities that constitute the current standard of care. Intervention will last for a total     of 6 months for each participant once enrolled.      Hypothesis:Participants in the intervention group being supplemented with 200mcg of     phytonadione will spend more total time with a therapeutic INR than participants in the     control group.   "
138306|NCT01474447|"     The purpose of the research is to check the efficiency of practicing the tools of the     Grinberg method (GM) in reducing Low-back Pain (LBP), reducing limitations in movement as a     result of the pain, and improving the general quality of life.      The hypothesis suggests that by learning to perceive pain differently, the level of pain will     reduce and general well-being improved.   "
138307|NCT01474434|"     This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact     cardiovascular risk.   "
138308|NCT01474421|"     This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate     to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's     disease.   "
138309|NCT01474408|"     The primary aim is to determine the acute effect of two different training interventions on     venous plasticity in patients with myocardial infarction (MI), revascularization or coronary     artery graft surgery compared to age-matched healthy subjects.   "
138310|NCT01474395|"     Persistent neurocognitive deficits are a major cause of severe disability and impaired     long-term psychosocial outcome in schizophrenia (SZ). In particular, within the auditory     system, early deficits such as the behavioral and neurophysiological ability to match tones     that vary in pitch correlate with impairments in auditory emotion recognition (affective     prosody) and general functioning, suggesting that interventions aimed at remediating     sensory-level dysfunction may lead to significant improvement in higher order     cognitive/emotion processes. Efforts to ameliorate cognitive deficits in schizophrenia     utilize either pharmacological agents or behavioral treatments such as cognitive remediation,     which generally focus on higher order processes, and not on the early sensory processing     which may be key to functioning.      Numerous pharmacological agents have been proposed, but accumulating evidence suggests that     dysfunction of the N-methyl-D-aspartic acid (NMDA) receptor may be one of the root causes of     schizophrenia, including sensory and cognitive impairments, suggesting that an NMDA based     treatment may be efficacious in reversing these deficits. D-Cycloserine, a synthetic partial     NMDA agonist has been used in anxiety disorders to augment learning in cognitive remediation.     Because of a tendency to act as an NMDA antagonist at higher doses D-cycloserine is not     effective in schizophrenia. In contrast, D-serine (DSR), is a full agonist, and is therefore     more ideal for enhancing NMDA function and cognitive remediation. While previous use of DSR     was limited by safety concerns in rodents,the investigators have shown that it can safely be     used at doses of 60 mg/kg and, moreover, demonstrates converging improvement in symptomatic,     cognitive and sensory-based measures in schizophrenia. Evidence also suggests that NMDA     receptor dysfunction in schizophrenia may be relative, rather than absolute, suggesting that     the enhanced practice of a cognitive remediation paradigm might be able to overcome reduced     plasticity and treat cognitive dysfunction.      This project will be the first to combine the NMDA based and sensory-based cognitive     remediation (SBR) approaches, and will utilize not only DSR, but also a tone matching SBR     paradigm has been shown to enhance learning in healthy controls, as well as a paradigm     designed to augment visual motion detection. This study will pilot these interventions in a     double-blind, placebo-controlled, randomized crossover design that will use neurophysiology     together with cognitive tests to explore the effects on brain activity and cognitive function     in 16 patients with schizophrenia or schizoaffective disorder. The investigators hypothesize     that DSR+SBR will lead to improvement. Subjects will have an initial visit to establish     baseline performance on cognitive tasks before returning for 3 visits when they will receive     blinded study medication [60 mg/kg of DSR (2 days) or placebo (1 day)] in a randomized order.     The procedures on the treatment days will include the SBR paradigm and pre/post     neurophysiological measurements. Primary outcomes are improvements in neurophysiologic and     behavioral sensory processing. The main goal is to establish the preliminary efficacy to use     in a follow-up multi-dose study utilizing a multiple session SBR R01 application.   "
138311|NCT01474382|"     The purpose of this study is to determine whether OraVerse is safe and effective for the     reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.   "
138312|NCT01474369|"     The purpose of this study is to investigate the superiority of efficacy of TAK-438, once     daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.   "
138328|NCT01474161|"     The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to     compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60     mg GFT505) and the old GFT505 formulation (capsule dosed at 20 mg GFT505) in healthy male     subjects and to assess the impact of gender on this relative bioavailability after     administration in male and female subjects.      Using the new formulation, a single and a multiple ascending dose study will be performed in     overweight or obese male subjects otherwise healthy whose demographic and physiological     characteristics are thought to be closer to those of the target population (Type 2 diabetes).     Thereafter, a group of male and female patients with Type 2 diabetes will receive multiple     dose administration of GFT505.   "
138313|NCT01474356|"     The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with     interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free     survival (DFS), or acute and late side effects in patients with advanced cervical cancer.     Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG     score. Following the completion of radiochemotherapy, consecutive patients with cervical     cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT     alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were     included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was     administered for 45 minutes before and during the HDR BT. Follow-up examinations were     scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and     every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained     from these patients.   "
138314|NCT01474343|"     The clinical trial P1-SAF-301 is an open-label, single arm, monocentric, phase I/II clinical     study evaluating the tolerance and the safety of intracerebral administration of     adeno-associated viral vector serotype 10 carrying the human SGSH and SUMF1 cDNAs for the     treatment of Sanfilippo type A syndrome The treatment plan consists on a direct injection of     the investigational medicinal product SAF-301 to both sides of the brain through 6     image-guided tracks, with 2 deposits per track, in a single neurosurgical session.      The primary objective is to assess the tolerance and the safety associated to the proposed     treatment through a one-year follow up.      The secondary objective is to collect data to define exploratory tests that could become     evaluation criteria for further clinical phase III efficacy studies.      Four patients will be included in the clinical trial and will be followed during one year.      The enrollment and the follow-up of the patients will take place at Bicêtre Hospital. The     Neurosurgery will be performed at Necker-Enfants Malades Hospital.      Safety will be evaluating on clinical, radiological and biological parameters.   "
138315|NCT01474330|"     To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered     orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.   "
138319|NCT01474278|"     This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and     the safety and tolerability of a single dose of RO5028442 in adult male high-functioning     autistic patients. In a cross-over design, patients will be randomized to receive either a     single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated     time on study is up to approximately 9 weeks.   "
138320|NCT01474265|"     This study has the following primary aim:      - the main objective of this study is to investigate the effects of smoking cessation during     quit attempts on sympathovagal balance. These effects will be observed in smokers quitting     smoking with pharmacological support or without.      Secondary aims of this study are also:        -  the definition of MSNA in smokers and non-smokers        -  the investigation of other parameters concerning the autonomic nervous system, like          baroreflex-sensitivity, heart rate-variability before and during the quit attempt.        -  the definition of withdrawal symptoms and craving before, during and after the quit          attempt.        -  the investigation of effects of smoking cues on craving and sympathovagal balance        -  the investigation of relapse rates after smoking cessation in correlation with the          parameters mentioned above.   "
138321|NCT01474252|"     The purpose of this study is to evaluate intubation duration between rapid sequence     intubation technique (RSI) and non-rapid sequence intubation technique (non-RSI) performed by     emergency medicine residents in Siriraj hospital.   "
138322|NCT01474239|"     This randomized, non-comparative study will evaluate the efficacy and safety of Avastin     (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive     Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15,     followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with     fotemustine serves as a calibration arm and no formal efficacy comparison will be made     between the two treatment arms. The anticipated time of study treatment is until disease     progression or unacceptable toxicity.   "
138323|NCT01474226|"     The purpose of this study is to investigate the digestibility of the amino acid lysine in     cooked rice in adult men using stable isotope technique.   "
138324|NCT01474213|"     The purpose of this study is to compare the sedation effect of dexmedetomidine and target     controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing     oral maxillofacial surgery.   "
138325|NCT01474200|"     The purpose of the research is to determine if patients have fewer Heart Failure (HF) events     after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90     days of discharge from the hospital. Heart Failure events are defined as returning to the     hospital, clinic or emergency department (ED) for treatment of HF symptoms.   "
138326|NCT01474187|"     Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy     (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some     current studies showed that irinotecan's dose can be increased significantly for those     patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial     to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.   "
138327|NCT01474174|"     This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients     with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective     immune response and help prevent flu in patients who are receiving chemotherapy for CNS     tumors   "
138331|NCT01474122|"     The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial     fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing     Period 1 continue on their original randomized treatment into Period 2, until the last     randomized patient has completed Period 1.      Patients are randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).      The primary objective is to demonstrate the effect of macitentan on the reduction of the     number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers     (DU).      Other objectives include:        -  the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week          16 in SSc patients with ongoing DU disease.        -  the evaluation of the safety and tolerability of macitentan in these patients.        -  the evaluation of the efficacy of macitentan on time to first DU complication during the          entire treatment period.   "
138332|NCT01474109|"     The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial     fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing     Period 1 will continue on their original randomized treatment into Period 2, until the last     randomized patient has completed Period 1.      Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).      The primary objective is to demonstrate the effect of macitentan on the reduction of the     number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers.      Other objectives include:        -  the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week          16 in SSc patients with ongoing DU disease.        -  the evaluation of the safety and tolerability of macitentan in these patients.        -  the evaluation of the efficacy of macitentan on time to first DU complication during the          entire treatment period.   "
138333|NCT01474096|"     The purpose of this study is to determine whether an implementation strategy for a     breastfeeding guide is more effective than the usual practice (simple circulation of the     guide) in terms of increasing the percentage of children receiving exclusive or preferential     breastfeeding at 6 months age.   "
138334|NCT01474083|"     The purpose of this trial is to study the drug levels and biomarkers in the body and the     safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the     study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4     treatments will be placebo, which does not contain an active ingredient. The study     participation includes in-patient and out-patient days.   "
138335|NCT01474070|"     IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation     tonometry (GAT)).   "
138462|NCT01472497|"     Insulin resistance is often complicated with hypertension. AGE and inflammation play     important roles in insulin resistance. Some studies reported that pioglitazone, insulin     sensitizer, is effective for patients with insulin resistance, however, the mechanisms are     still unclear. The aim of this study to evaluate the effect of pioglitazone compared with     glimepiride on AGE, inflammatory cytokines and cardiac markers (BNP and echo) in hypertensive     patients during oral glucose tolerance test.   "
138336|NCT01474057|"     This study will compare a cognitive-behavioral online self-management intervention designed     for primary care treatment of war-related PTSD to a control intervention, optimized usual     primary care PTSD treatment. Patients with PTSD will be trained to use the online PTSD     treatment website and asked to do so three times per week for six weeks. They will have phone     and email access to a nurse trained to assist them in their treatment program. Three     scheduled phone check-ins during the six week treatment period will provide ongoing contact     with patients during treatment. The investigators will assess PTSD symptoms, depression,     anxiety and somatic symptoms, physical health status and occupational functioning on three     occasions: before the intervention, at the end of the treatment period, and six weeks after     the end of treatment.   "
138337|NCT01474044|"     The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and     effective in the treatment of chronic atrophic gastritis (CAG).   "
138338|NCT01474031|"     Research protocol prospective study Deltamotion - DAA THA study        1. Introduction Very few gait analytical data are available concerning the Direct Anterior          Approach (DAA) in total hip arthroplasty (THA). All the studies have focused on          immediate post-operative recovery. These studies have in general some important          shortcomings in order to accurately evaluate the biomechanics of the replaced hip joint.          None of the published reports have reported on consecutive intervals of pre-op - 6w - 3m          - 6m - 12m. This is of interest as we know that recovery with other approaches takes >1          year. It might be that the DAA approach leads to normal gait patterns at 3m or 6m and          that these patterns do not differ from the normal pattern or at >1y post-op. None of the          reports utilized out-of-plane movements such as coming down or up stairs or squads.          Muscle strength of the abductors has not been tested. Utilizing trunk markers is          frequently not done but it is important to evaluate the centre of mass position during          gait. Very few studies utilize kinetic data, which are important in order to thoroughly          evaluate the biomechanics and loading of the hip. And maybe most importantly, the          biomechanical effect of the diameter of the articulating surface on gait parameters          following the DAA has never been evaluated.           One of the most important advantages of the DAA is the muscle sparing aspect and the          presumption that the femoral anatomy and biomechanics can be more accurately and          precisely restored. If the diameter of the articulating surface has then also been          reconstructed to the almost anatomical diameter, we can assume that this should be the          most optimal reconstruction of the hip joint currently available. This could lead to          early return to normal gait, to optimal joint loading and a minimal amount of stress          shielding of the femoral bone.           The aim of this project is (1) to prospectively analyse the biomechanics of the hip          joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior          Approach and (2) to assess the femoral bone remodelling around the fully coated Corail          stem over the first year post-operatively.        2. Materials and Methods Hypothesis: (1) The temporo-spatial parameters (velocity, cadence,          step length, and stride length) and gait kinematic and kinetic data (external hip and          knee muscle moments) are not significantly different between the study and control group          at the evaluated time intervals indicating normal or near normal gait patterns in the          early post-operative recovery phase. (2) Stress shielding of the bone around the femoral          stem as measured with the DEXA scan can be predicted accurately with the FE analysis          based on the collected data indicating the validity of the musculoskeletal models.      Estimated inclusion time: 1 July 2011 - 31 December 2011 Cohorts: 20 DAA subjects - 20     control subjects      Assessments:        -  Time interval: pre-op - 3m - 6m - 12m        -  Assessment of all subjects:             -  XR with magnification marker             -  Biodex force measurement in flexion and extension and mid flexion (with EMG if               possible)        -  Gait analysis with surface EMG and trunk markers:             -  Unipodal standing: 3 trials Right and 3 trials Left on FP             -  Level walking: 3 trials Right and 3 trials Left on FP             -  Chair rise: 3 trials, both legs on FP             -  Stair ascent: 3 trials Right and 3 trials Left on first FP             -  Stair descent: 3 trials Right and 3 trials Left on first FP             -  Squat: 3 trials, both legs on FP             -  Bipodal squat: 3 trials Right and 3 trials Left on FP        -  Functional scores (HHS, UCLA, HOOS, SF-36)        -  DEXA scan pre-op and at 12 months        -  Assessment of final 5 subjects per group:             -  CT pre and post at 6w (pre: pelvis-knee and post: hip)             -  MRI pre and 1 y post             -  Accelerometer 1 week   "
138339|NCT01474018|"     QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2     diabetes will result in improved glycemic control, reduced exogenous insulin requirement,     increased lean fat mass and improved pancreatic beta-cell function.   "
138340|NCT01474005|"     This study aims to evaluate the effectiveness of an artificial larynx on the restoration of     laryngeal functions, mainly breathing and swallowing.   "
138341|NCT01473992|"     The purpose of this study is to determine if transfemoral amputees of varied etiology will     demonstrate increased function, safety and quality of life following accommodation with a new     knee prosthesis as compared to their former C-Leg knee prosthesis.   "
138342|NCT01473979|"     Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-treating     complication after the cardiac surgery. The incidence of sternal osteomyelitis ranges from 1%     to 3% with a high mortality rate from 19% to 29% .      The most devastating complication of the open sternum is the laceration of the right     ventricle which has a very high mortality. Additionally destabilizations of the thoracic     cage, prolonged immobilization, or substantial surgical trauma are further complications of     the conventional strategy (4). In addition, postoperative infections after sternotomy are     associated with prolonged hospital stay, increased healthcare costs and impaired quality of     patient life, representing an economic and social burden. The emergence of increasing     antimicrobial resistant bacteria augments the importance of postsurgical infections since the     antimicrobial choices are becoming limited. Furthermore, the incidence of infection is an     indicator for the quality of patient care in the international benchmark studies.      Although several therapy strategies are nowadays present in clinical practice, there is a     lack of evidence based surgical consensus for treatment of this surgical complication. In     most case the poststernotomy mediastinitis is involving surgical revision with debridement,     open dressing and/or vacuum assisted therapy. After the granulation tissue on open chest     wound was achieved secondary closure and/or reconstruction with vascularized soft tissue     flaps such as omentum or pectoral muscle is performed.      It seems there is a need for more effective surgical treatment of poststernotomy wound     infections, which may address the prolonged hospitalization and reduce number of surgical     interventions and with this also perioperative morbidity. In light of this we propose a     randomized study comparing new delay primary closure of the sternum to the secondary vacuum     assisted closure.   "
138343|NCT01473966|"     Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit     (ICU) patients.   "
138344|NCT01473953|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     investigate the safety, tolerability and pharmacokinetics (exposure in the body) of     liraglutide-depot in healthy subjects.   "
138345|NCT01473940|"     This phase I trial studies the side effects and best dose of ipilimumab when given together     with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent pancreatic     cancer that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can     block tumor growth in different ways. Some block the ability of tumor cells to grow and     spread. Others find tumor cells and help kill them or tumor-killing substances to them. Drugs     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to kill tumor     cells or stop them from growing. Giving monoclonal antibody therapy together with     chemotherapy may kill more tumor cells.   "
138346|NCT01473927|"     Background Determining disease activity in IBD is sometimes difficult and, to be accurate,     requires endoscopy. The serum marker CRP has not proven sufficiently valuable as a marker for     IBD specific inflammation. As an alternative, so far fecal calprotectin appears to be more     reliable and has shown a certain value as predictive marker. Our preliminary data now show,     that the serum concentrations of ficolin-2 are significantly higher in CD patients with a HBI     >3. Ficolin-2 is a lectin and acute phase protein produced in the liver and, like MBL, can     activate the lectin pathway of complement. Unlike MBL, deficiency for ficolin-2 was not     detected in our patient cohort, nor could we find functional deficiencies for ficolin-2     (paper submitted).      Study Aims The study is aimed to substantiate the data from our pilot study which shows that     ficolin-2 is significantly increased in CD patients during inflammation. Therefore, the study     will measure ficolin-2 concentrations in a sufficiently large patient group to obtain enough     statistical power and to compare these results with the endoscopic disease score (SES-CD) and     CRP and calprotectin values. Statistical analysis of the data will show us if ficolin-2 is a     reliable and easy to obtain new marker for active inflammation in CD.      Study Design Based on a power analysis 112 CD patients and 112 UC patients need to be     analyzed. They will be recruited from Bern, Basel and Lausanne. Only patients with routine     endoscopy will be included in the study and will be scored by SES-CD. Blood samples will be     collected at the day of endoscopy. Stool sample will be collected within the same week of     endoscopy. Calprotectin and CRP concentrations will be determined by routine diagnostics,     ficolin-2 concentrations will be determined by ELISA in our laboratory. Finally, all data     will be statistically analyzed.   "
138347|NCT01473914|"     A pilot randomized trial that compares a new renal nutritional supplement with the standard     renal vitamin.      The primary objective is to compare two doses (medium and high) of the new supplement with     the renal vitamin currently being prescribed to people with End Stage Renal Disease (ESRD).      Secondary objective is to demonstrate the feasibility of recruitment for a definitive larger     trial.   "
138348|NCT01473901|"     This clinical study will assess the doses of BKM120 appropriate for patients with newly     diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.   "
138349|NCT01473888|"     Purpose: This study is to determine the effect of T89(Dantonic®)on P450 enzymes. This study     will help determine which types of drugs may interact with T89.   "
138350|NCT01473875|"     This phase 2/3, open-label extension study will evaluate the long-term efficacy and safety of     intravenous (IV) infusions of SBC-102 in children with Lysosomal Acid Lipase (LAL) Deficiency     who previously received treatment with SBC-102.   "
138351|NCT01473862|"     Teen loss is not uncommon. Depression, emptiness, disbelief, hopelessness, and guilt are     typical responses. How teens with cancer cope with the loss of a loved one or a close friend     has not been well-studied in the bereavement or oncology literature. This study will describe     the impact of loss on teen patients who are on treatment or have recently completed treatment     for malignancy. We will look at baseline personality traits and ask teens to identify losses     in their life. We will ask questions about coping and meaning-making after loss. A parent     will be invited to participate -to measure parental awareness of teen loss and determine if     parental coping affects teen coping. The inventories have been validated by other     researchers.   "
138352|NCT01473849|"     The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver     transplant recipients remains controversial. Although some studies (Teixeira et al., 2000;     Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV     infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered     cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To     clarify this question, a non-interventional study will be carried out in order to assess if     CMV replication is a risk factor for graft dysfunction in liver transplant recipients.   "
138353|NCT01473836|"     The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult     subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day     in combination with ceftriaxone sodium.   "
138354|NCT01473823|"     Although some causal factors in allergy development such as allergen exposure and     environmental pollution have decreased during recent years, the incidence of the allergic     diseases has increased in the Western world. Since the genetic predisposition to develop     allergies cannot change in such a short time it is conceivable that, instead of the emerging     of some new and unknown risk factors, some protective factors seem to have disappeared in the     Western world.      Allergic disease is a tendency to develop allergies to allergens in the surrounding     environment. The most common symptoms are eczema and food allergy in the early life,     bronchial asthma (AB) later in childhood and allergic rhino conjunctivitis (ARC) during     school age and adolescence, the so-called allergic march. Some person may develop only one,     but others some or all of the symptoms. Inheritance, environment and allergen exposure are     important factors affecting this march but there are important factors that predict later     development of diseases. Sensitization to egg (positive skin prick test or specific IgE to     egg in the serum) combined with skin problems in infancy predispose strongly to the     development of allergic asthma in later life.      The purpose of this work is to supply children with early development of IgE associated     eczema and food allergy with omega-3 LCPUFA before the age of 12 months and assess the effect     of the supplementation on the future development of skin symptoms, food allergy,     sensitisation against inhalant allergens and asthma in these children. We will also assess     immunological markers of Th2-skewed immunity in relation to clinical effect of the     supplementation.      Families with children younger than 12 months referred to the paediatric department at     Linköping University Hospital, Motala, Norrköping and Jönköping Hospitals in the South East     of Sweden, with the diagnosis IgE associated eczema and sensitised against food allergens     (egg, milk, wheat and/or soya) will be invited to participate in this study. Clinical     examination by a paediatrician and assessment of disease severity with SCORAD will be     performed by a research nurse at inclusion. The children will be assessed every six months by     a nurse until 2.5 years of age and by a paediatrician at 3 years of age. Later clinical     assessment will be performed yearly until age 7.   "
138355|NCT01473810|"     HIV-specific cellular immunity is hampered in most HIV-infected individuals. Therapeutic     immunization in HIV aims to strengthen the HIV-specific cellular immunity, usually in the     absence of replicating HIV with antiretroviral drugs. The aims of this strategy can be to     decrease the mass of latently infected CD4+ T cells, better tolerance of drug-free periods,     and better select candidates for preventive HIV vaccines.      Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four,     slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal     injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found     improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at the     AIDS vaccine 2011 conference, Bangkok).      In this study the investigators hypothesize that the Vacc-4x peptides, deposited on the nasal     mucosal surfaces in conjunction with Endocine, a newly developed and documented mucosal     adjuvant, will induce T cell responses to HIV and improve HIV-specific immunity both     systemically and at mucosal surfaces (oral, rectal, vaginal).   "
138356|NCT01473797|"     ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5     days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary     Langerhans cell histiocytosis and impairment of lung function patients.   "
138357|NCT01473784|"     This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with     benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for     head and neck cancer and may have fewer side effects and improve recovery   "
138358|NCT01473771|"     The purpose of this multi-site randomized controlled trial is to determine if the Caring     Letters intervention is effective in preventing suicide and suicidal behaviors among U.S.     Service Members and Veterans. The primary aim of this project is determine whether caring     communications following inpatient psychiatric treatment reduce suicide and self-inflicted     injuries among U.S. military personnel and Veterans. The investigators will also explore     treatment utilization by comparing the frequency of treatment visits after enrollment into     the study. The following specific hypotheses will be tested:      Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency     of suicide will be lower among participants in the Caring Letters group compared to those in     the Usual Care group.      Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower     in the Caring Letters group compared to the Usual Care group.      Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be     longer among participants in the Caring Letters group compared to the Usual Care group.   "
138359|NCT01473758|"     The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic     inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In     addition, the potential benefit of roflumilast on severity and recovery periods of acute COPD     exacerbations will be assessed using patient diaries and questionnaires.   "
138360|NCT01473745|"     study hypothesis        1. The aim of this study:           How can the investigators predict and control the nasal changes after maxillary LeFort I          osteotomy with 2 different alar base suture techniques ?        2. Study hypothesis             -  Null hypothesis: Nasal changes were not affected by 2 different alar base suture               techniques after maxillary LeFort I osteotomy             -  Alternative : Nasal changes were affected by 2 different alar base suture               techniques after maxillary LeFort I osteotomy   "
138361|NCT01473732|"     The purpose of this study is to find out how well the current drug regimen (including low     Prograf dose and Myfortic, which is usually recommended to prevent any further deterioration     in the kidney function) works and how safe it is when compared to a combination of Zortress     and Myfortic in patients with chronic kidney injury associated with Prograf or Neoral use.   "
138362|NCT01473719|"     The purpose of this study is to if a brief motivational intervention, compared to health     education sessions, reduces alcohol and marijuana use and is related to fewer sexually     transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.   "
138363|NCT01473706|"     The purpose of this study is to compare the accuracy of a new consumer nutrition screening     tool to an established and validated nutrition screening tool currently completed by     healthcare practitioners.   "
138364|NCT01473693|"     The purpose of this study is to learn about the effects of cancer treatment on the brain.     Some cancer patients report changes in their memory or thinking after treatment. These     changes could be a result of changes in brain structure, such as a change in size or     thickness of different parts of the brain. The investigators will look to see if these     changes in brain structure happen through the results of magnetic resonance imaging (MRI).     The investigators will do this by looking at the brain structure of lung cancer patients who     have surgery and chemotherapy versus those who have surgery only.   "
138365|NCT01473680|"     This study is being done to find out if it is possible to enroll minority women with breast     cancer in a study of how chemotherapy may affect their ability to answer certain questions     and perform certain tasks that measure brain activity. The investigators want to look at     thinking and brain activity in patients to see if cancer treatments can cause any brain     changes. For this study, women without cancer, are being asked to participate in order to     compare the answers to the questions and the brain wave activity measured in the women with     cancer to women who don't have cancer.   "
138366|NCT01473667|"     The purpose of this study is to investigate clinical outcomes from two current standard of     care pain control procedures performed for patients undergoing pacemaker insertion.   "
138367|NCT01473654|"     The goal of this randomized control trial is to study the impact of an electronic health     record embedded tool's ability to facilitate shared provider-patient goal setting to promote     lifestyle behavior change and prevent diabetes in primary care.   "
138368|NCT01473641|"     This study characterises the frequency of specific insertion-, localization- and     removal-related events and clinically significant consequences thereof among Nexplanon users     in the US during routine clinical use.   "
138369|NCT01473628|"     The goal of this clinical research study is to learn if adding rituximab to radiation therapy     will help control the disease better than radiation alone. The safety of this combination     will also be studied.      Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.      Rituximab is designed to attach to cancer cells that have CD20 (a tumor marker) on their     surface and damage them, which may cause the cells to die.   "
138370|NCT01473615|"     The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based     Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with     chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a     psychological and neurobiological level. For this purpose the study subjects will fill out     several psychological questionnaires related to mindfulness, depression and chronic pain.     Moreover this study involves optional fMRI scans of the brain and blood measures before and     after the intervention.      Main hypotheses:        1. The MBCT training will be a feasible intervention in patients with chronic pain and          co-morbid depression as defined by no occurrence of serious adverse events related to          the intervention and a retention rate of more than 70% in the subjects assigned to the          MBCT arm.        2. Patients who have completed the MBCT training will demonstrate a significant decrease in          depressive symptoms as measured on the Quick Inventory of Depressive Symptomatology -          Clinician rated (QIDS-C16), and the Hamilton Rating Scale for Depression (HRSD17)          (QIDS-C/HRDS) severity scale for depressive symptoms (the primary outcome measure),          compared to the control group.   "
138371|NCT01473602|"     The purpose of this study is to see whether teriparatide, given for 6 months versus placebo,     will improve the healing of hip (femoral neck) fractures that are repaired during surgery     using certain types of orthopedic screws. The study will enroll men and postmenopausal women     at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for     example, fall from standing height or less).   "
138372|NCT01473589|"     The purpose of this study is to see whether teriparatide, given for 6 months versus placebo,     will improve the healing of hip (femoral neck) fractures that are repaired during surgery     using certain types of orthopedic screws. The study will enroll men and postmenopausal women     at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for     example, fall from standing height or less).   "
138373|NCT01473576|"     A diet rich in leafy green vegetables has been shown to reduce the risk of developing chronic     metabolic disease. The health benefits from these particular vegetables may be attributed to     their high nitrate content. Recent work suggests that dietary nitrate triggers endogenous     nitric oxide release, thereby stimulating vasodilation and improving muscle perfusion in an     insulin-independent manner. We hypothesize that in an insulin-resistant state, nitrate     co-ingestion will increase muscle perfusion, thereby improving post-prandial delivery of     nutrients to skeletal muscle tissue. Specifically, a more efficient delivery of food derived     amino acids will stimulate post-prandial muscle protein synthesis and, as such, compensate     for a blunted muscle protein synthetic response to food intake in the elderly. This proposal     will investigate the efficacy of nitrate co-ingestion as a means to augment muscle protein     synthesis in elderly, type 2 diabetes patients and may lead to a novel therapy in the     clinical care of type 2 diabetes patients.   "
138374|NCT01473563|"     The main purpose for this study is to answer the following research questions:        -  Can pemetrexed be administered safely at the participant's home, using the same          treatment procedure as in a hospital setting?        -  Will the participant be satisfied with home care?        -  How might this impact the participant's quality of life?        -  What are the required medical resources needed to give pemetrexed in a home setting?   "
138375|NCT01473550|"     Patients with mood disorder or psychotic disorder will be given handheld devices with     personal health records to educate, monitor and deliver customizable healthcare tools based     on their personal needs. The use of technology has great potential to deliver care more     effectively and efficiently. No actual information is on the handheld device - it is accessed     from a secure site behind hospital firewalls.   "
138392|NCT01473329|"     Education is the mainstay of treatment of diabetes mellitus (DM), since it is through her     that patients are trained to perform the management of your disease. There is a wide range of     educational interventions tested in patients with DM, not having been defined so far a     universal template that can be standardized and recognized as effective for all individuals     with the disease. The present study aims to evaluate the effect of a group based structured     education program, applied by a primary care generalist nurse, on metabolic control of type 2     diabetes mellitus (DM2) patients attending a primary care unit.   "
138376|NCT01473537|"     Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design:     Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution     (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.      Procedure: Rinses are performed in the evening. The rinse combinations are given in a random     order, and the subjects are unaware of the sequence. At least 3 days separates the use of     each rinse. Dosage: 20 mL and 1 minute rinse with each solution.      Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by     expectoration.      Analysis: The fluoride concentration in saliva samples are analysed Statistics and data     handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated     measures design.   "
138377|NCT01473524|"     The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist. FXR     is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to     help with digestion. It is hypothesized that regular treatment with OCA will improve liver     function in persons with Primary Biliary Cirrhosis (PBC).   "
138378|NCT01473511|"     Strongest Families (formerly Family Help)is an evidence-based, distance health education     model for families who have children with behavioural difficulties. The principal research     question is Does Strongest Families, a 12-week, home-based program of interactive readings,     instructional videos, homework projects, and weekly coaching telephone calls out perform     the care families typically experience when referred to a mental health service?. The     investigators hypothesize that children randomized to Strongest Families intervention will     show a significantly greater reduction in externalizing behaviour problems than those     randomized to a Control (usual care). In addition, parents randomized to Family Help will     report a greater improvement in parenting skills and a greater reduction in symptoms of     emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the     Control condition. Finally, families randomized to Family Help will use fewer mental health     services than Controls.   "
138379|NCT01473498|"     Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury     (AKI) is commonly encountered in critically ill patients and independently predicts poor     outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI.     To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated     by renal Doppler could lead to a better renal perfusion, and then less AKI.   "
138380|NCT01473485|"     A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound     Surgery in the Treatment of Brain Tumors   "
138381|NCT01473472|"     This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel     groups is designed to evaluate a strategy for the prevention of HIV infection including on     demand antiretroviral pre-exposure with Truvada versus placebo, associated with overall     prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B     virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV     infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed     recent studies have reported a higher incidence of new HIV infection in MSM as compared to     the general population, new approaches to the prevention of HIV infection are, therefore,     necessary in order to consider the limits of current strategies.   "
138382|NCT01473459|"     The purpose of this study is to compare two fertility protocols in obese women with     Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These     protocols carry less risk of ovarian hyperstimulation syndrome which these women may     experience.   "
138383|NCT01473446|"     Is goal directed fluid therapy reducing postoperative complications in comparison to     traditional fluid therapy for gastro surgical ASA III/IV patients?      The investigators compare two groups of patients: one group receives goal directed fluid     therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the traditional     fluids, ie the current regime.   "
138384|NCT01473433|"     The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle     transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic     myocardial infarct. Preclinical studies in the porcine model of myocardial infarction have     shown that AdiFLAP reduces infarct area.   "
138385|NCT01473420|"     The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC)     Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels     and study drug dose requirements in patients treated for anemia associated with chronic renal     failure and on hemodialysis.   "
138386|NCT01473407|"     The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira     compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose     requirements in patients treated for anemia associated with chronic renal failure and on     hemodialysis.   "
138387|NCT01473394|"     The purpose of this study was to further characterize the efficacy, safety, and tolerability     of a single fixed dose level of vilazodone compared to placebo in patients with major     depressive disorder.   "
138388|NCT01473381|"     The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed     dose levels of vilazodone compared to placebo in patients with major depressive disorder.   "
138389|NCT01473368|"     The purpose of this study is to compare and contrast the effects of the probiotic     Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the     gut microbiota of healthy volunteers.   "
138390|NCT01473355|"     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 3mm     diameter implant in a Chinese population by evaluation of marginal bone level alteration,     implant stability and implant survival in the posterior mandible up to 3 years after loading.     Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.   "
138391|NCT01473342|"     This study is focused on the development and pilot/feasibility testing of a smartphone     application to promote a healthy diet, increase physical activity, and prevent weight gain in     adolescent survivors of childhood cancer.   "
138393|NCT01473316|"     This will be an open-label, fixed-sequence, single-center, 2 period study. The study is     designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.   "
138713|NCT01469091|"     The purpose of the study is to see whether intensive smoking intervention on the day of     operation can reduce per- and postoperative complications in patients operated for acute     ischaemic disease compared to control group with no intervention.   "
138394|NCT01473303|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan     hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to     grow and spread. Others find tumor cells and help kill them or carry cancer-killing     substances to them. It is not yet known whether giving more than one drug (combination     chemotherapy) is more effective with or without ganitumab in treating patients with     pancreatic cancer.      PURPOSE: This phase I/II trial is studying the best dose of combination chemotherapy and     ganitumab and how well combination chemotherapy with or without ganitumab works in treating     patients with previously untreated metastatic pancreatic cancer.   "
138395|NCT01473290|"     RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients     undergoing chemotherapy and pelvic radiation therapy.      PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in     preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic     radiation therapy.   "
138396|NCT01473277|"     The aim of this study is to confirm the efficacy and safety of the intra-articular injection     of BT-A in a multicentric double blind randomised study. For this purpose intra-articular     injection of BT-A will be compared with the intra-articular steroid injection that is the     current gold standard for the treatment of HSP.   "
138397|NCT01473264|"     Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result     of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical     ventilation and infection. These conditions initiate an inflammatory response characterized     by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the     development of significant acute and chronic lung injury.      The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10     is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is     the most abundant protein in the mucosal fluids in normal healthy lungs.      The purpose of this study was to evaluate the pharmacokinetics, safety, tolerability and     anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated     premature infants receiving positive pressure ventilation for treatment of respiratory     distress syndrome (RDS) to prevent long term respiratory complications referred to as     bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM;     asthma, cough, wheezing, multiple respiratory infections).      CC10 regulates inflammatory responses and protects the structural integrity of pulmonary     tissue while preserving pulmonary mechanical function during various insults (eg. viral     infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties     suggest that administration of rhCC10 may help to facilitate development of normal airway     epithelia and prevent the inflammation that leads to CRM in these infants.   "
138398|NCT01473251|"     The purpose of this study is to measure biomarkers in the vitreous of patients undergoing     Lucentis or avastin treatment.   "
138399|NCT01473238|"     Paper-based data collection for prospective clinical trials is associated with a poor quality     of data collection. This typically involves missing or wrong data entry or a low recruitment     rate, mainly due to the cumbersome and uncontrolled data collection.      Electronic data collection is associated with improved quality of data entry in the cases of     Electronic Patient Records (EPR) and patient handover among doctors during night and day     shifts. However, a comprehensive direct comparison between web-based desktop personal     computer (PC) and mobile (e.g. iPad) data collection has not yet been reported.      The purpose of this prospective trial is to compare the users' experience with the web-based     desktop PC and mobile data collection (iPad) tools.   "
138400|NCT01473225|"     This study is a test of possible mechanisms by which calorie labels might lead people to     increase calorie intake. The investigators hypothesize that calorie labels might increase     calorie intake because 1) people infer that higher calorie foods are tastier, 2) calorie     labels invoke thoughts of dieting, leading people to overconsume as a reaction, 3) people try     to maximize calories consumed per dollar spent, and 4) calorie labels change one's goal     motivation toward food, causing people to eat more.   "
138401|NCT01473199|"     Information will be collected on the pre-op and post-op clinical status of patients with     focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial     Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to     increase the knowledge of patient outcomes such as pain, knee function, level of activity,     and overall quality of life after treatment with the device. Patients will be followed for 5     years after surgery.   "
138402|NCT01473186|"     Objectives: Given the profound impact of obesity on the genesis of endometrial cancer, this     study proposes to prospectively evaluate the baseline prevalence of menstrual irregularities     and endometrial pathology in morbidly obese women and discover risk stratification markers     that can potentially identify the highest risk women who might benefit from targeted cancer     prevention strategies in a future clinical trial.        -  Specific Aim 1: To assess the prevalence of menstrual irregularities and to correlate          gynecologic and menstrual history with the perceived personal risk and severity of          gynecologic cancers in a population of female bariatric surgery candidates.        -  Specific Aim 2: To determine the prevalence of endometrial hyperplasia and cancer in          morbidly obese women undergoing bariatric surgery.        -  Specific Aim 3: To obtain adipose, endometrium, and blood samples (before and after)          bariatric surgery to assess baseline hormone levels and adipocyte-derived factors and to          correlate with presence of menstrual irregularities, endometrial hyperplasia or cancer,          and with postsurgical weight changes.      Methods:        -  Specific Aim 1: After informed consent is obtained, a survey and medical history of          prospective bariatric surgery patients will be performed at the University of Virginia.        -  Specific Aim 2: For those women who undergo bariatric surgery, study investigators will          perform endometrial biopsies at the time of bariatric surgery on participants to          determine the status of the endometrial lining and the potential presence of endometrial          cancer and its precursors.        -  Specific Aim 3: At the time of surgery, blood, adipose, and endometrial tissue samples          will collected for evaluation of adipocyte-related factors and correlation with clinical          endpoints. Blood will also be collected at 6 and 12 months after surgery.      Anticipated results: This study will identify the prevalence and correlation of menstrual     irregularities with endometrial abnormalities and cancer in morbidly obese women as well as     define their perceived risk of developing cancer. Serum biomarkers in obese women with and     without endometrial cancer/precancer would be evaluated for correlation and potential     applicability for endometrial cancer screening in this high-risk population. Most     importantly, this study may provide evidence as to whether screening (via endometrial biopsy     or other serum markers) is warranted in asymptomatic, morbidly obese women and suggest     potential preventive and risk reduction mechanisms.   "
138403|NCT01473173|"     The objectives of this study are:        -  To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in          healthy male subjects.        -  To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy          male subjects.        -  To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy          male subjects.        -  To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and          esomeprazole in healthy male subjects.   "
138405|NCT01473147|"     Background: Continuous subcutaneous insulin infusion (CSII) has been demonstrated to be an     effective clinical tool for intensive insulin therapy in Type 1 diabetic patients. Type 2     diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1)     levels. Injection of GLP-1 receptor agonists are associated with improved glycemic control.     Nevertheless, the clinical effects and mechanisms are still unclear when additional     supplement of GLP-1 analogue in cooperation with intensive CSII treatment for poorly     controlled Type 2 diabetes patients. This study is designed to understand the complementary     pharmacological effects of GLP-1 analogue on intensive CSII treatment.      Methods: Sixty poorly controlled Type 2 diabetes patients will be admitted to the ward for 6     days CSII intensive treatment. Following the normalization of blood glucose at first 3 days,     the patients are randomly assigned with combined therapy with exenatide injection or saline     for another 3 days. The clinical assessments of insulin requirement, insulin secretion,     insulin resistance glycemic excursions and cytokines will perform immediately during or after     the study.   "
138406|NCT01472107|"     The GIMEMA FOUNDATION promotes an observational (retrospective) study on number and outcome     of pregnancy in childbearing age female patients treated with chemotherapy for APL. These     patients were enrolled in studies AIDA0493, AIDA2000 and were in CR.   "
138407|NCT01472094|"     The goal of this study is to develop a bedside to bench model of clinical and biological     predictors for toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast     cancer. The investigators will develop a predictive model using clinical and biological     predictors of toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast     cancer. The investigators will also determine the association between clinical and biological     factors and reduced relative dose intensity of the prescribed chemotherapy regimen. In     addition, the investigators will explore specific chemotherapy toxicities associated with     reduced relative dose intensity of a prescribed regimen.   "
138408|NCT01472081|"     The purpose is to determine the safety, effectiveness and best dose to use when giving     Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of     metastatic renal cell carcinoma.   "
138409|NCT01472068|"     This is a pilot clinical study taking place at one site in Berlin, Germany using     Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20 women     suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days out of     7 set treatment program with the device. After the 12 week treatment programme the subjects     will be asked to perform daily set exercises for a further 14 weeks.   "
138410|NCT01472055|"     The purpose of this study is to analysis of the pharmacokinetics of fludarabine for     hematopoietic stem cell transplantation in pediatric patients.   "
138411|NCT01472042|"     The purpose of this study is to study the biomarkers in subjects before and after     sports-induced traumatic brain injury. The assay will be studied in a sample population of     subjects over the age of 18 participating in college sports.   "
138412|NCT01472029|"     The purpose of this study is to determine the rate of complete pathological responses     (percentage of patients with pCR referring to the total number of enrolled and eligible     patients), as evaluated centrally by a reference pathologist.   "
138413|NCT01472016|"     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and     preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET     amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications,     is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the     activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.   "
138414|NCT01473121|"     This registry study is national, multi-center, prospective study without any interventions to     the treatment strategies and/or decisions of the investigators. It is designed in order to     determine the general profile of HCC patients in Turkey. Socio-demographic characteristics,     family history, medical history and treatment pattern of HCC patients will be evaluated.   "
138415|NCT01473108|"     Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this     single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in     healthy male subjects.   "
138416|NCT01473095|"     This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to     subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed     to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to     define a recommended Phase 2 dose of ARQ 092.   "
138417|NCT01473082|"     The purpose of this study is to evaluate whether patients with trochanteric fractures being     treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be     mobilized than patients without augmentation.   "
138418|NCT01473069|"     The purpose of this study was to determine the safety, tolerability and pharmacokinetics of     sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also     to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic     profile of JTK-853 and its metabolite M2 (one cohort only).   "
138419|NCT01473056|"     The purpose of this study was to determine the safety, tolerability, pharmacokinetics and     anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on     reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by     genotypic resistance monitoring for up to one year after study drug treatment.   "
138420|NCT01473043|"     This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell     variant), who have failed first line therapy. The study will recruit a maximum of 30 patients     from 2 countries including Australia and Canada. Patients will be followed up for efficacy,     safety and health related outcomes.   "
138421|NCT01473030|"     The overall goal of this project is to quantify the long-term effects of dutasteride on the     architectural and nuclear features of benign prostate tissue, using state-of-the art digital     image analysis techniques. The ultimate result will be a multivariable morphological     signature that could provide a useful indicator of an individual's degree of drug response.   "
138535|NCT01471444|"     The goal of this clinical research study is to learn if combining busulfan with clofarabine     and fludarabine can help control the disease better than the previous standard method (using     busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination     therapy will also be studied.   "
138422|NCT01473017|"     This study employs a Randomised Controlled Trial design to investigate whether a CBT-based     guided self-help intervention can improve anxiety, depression, psychological well-being,     quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to     recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and     depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes     control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid     mental ill-health, however little research has been done to date on the effect of guided     self-help in this population. It is expected that this intervention will improve patient's     mental health, as well as extend the limited knowledge-base on guided self-help in chronic     illness.   "
138423|NCT01473004|"     The purpose of this study is to determine whether radiation provided locally to the liver     tumor vasculature environment will demonstrate a response of tumor decline. This radiation     may cause the tumor cells to die.   "
138424|NCT01472991|"     Study is to assess if TC-5619 improves symptoms for adults diagnosed with the     inattentive-predominant subtype of ADHD over a 4-week treatment period.   "
138425|NCT01472978|"     The investigators found that community acquired C. diff occurs in children undergoing a     colonoscopy. When they were treated their symptoms got better. But, the investigators do not     know if the treatment for the C. diff made them better or another other factor made them feel     better. So, the investigators designed the following study. Children undergoing a colonoscopy     who are found to be C. diff positive at the time of the colonoscopy are randomized to one     group that gets immediate treatment or a second group that gets delayed treatment. Both     groups are closely monitored for symptoms.   "
138426|NCT01472965|"     Use of long-term central venous access devices (including tunneled lines and ports) can be     associated with development of bloodstream infection caused by build-up of bacteria or fungus     on the inside of the device, called central line associated bloodstream infection (CLABSI).     This infection generally requires hospital admission and antibiotic therapy. This treatment     usually helps eradicate the infection but sometimes it is not possible to clear or it comes     back after treatment. Also, once someone has had one line infection the chance of getting     another one is higher. This study will test whether treatment and secondary prophylaxis of     CLABSI with ethanol lock therapy (ELT) can significantly reduce the risk of treatment failure     (comprising failure to clear initial infection, relapse or reinfection) in children and     adolescents treated for cancer or hematologic disorders or undergoing hematopoietic stem cell     transplantation (HSCT). ELT involves injecting a solution of ethanol and water into the line     or port, allowing it to dwell for 2 hours, and then withdrawing the solution.   "
138427|NCT01472952|"     Sepsis remains a common entity in critical care patients with remarkable mortality. Despite     extended research activities, no reliable bio-markers or scoring systems attributing the     individual risk of developing sepsis have been found so far.      Patients with multiple trauma are at high risk of developing sepsis. Due to local and     systemic immune reactions, high plasma levels of known pro-inflammatory cytokines can be     found.      Simultaneously, certain anti-inflammatory reactions such as changes in immune cell activity     and serum cytokine levels, known as compensatory anti-inflammatory response syndrome (CARS)     take place.      In addition to changes of cytokine levels and immune cell activity, underlying genetic     reactions are present. For instance, expression of miRNA (as an potential important step of     immune cell activation) is likely changed during systemic and local immune reactions.      In the present study levels of pro- and antiinflammatory cytokines, a detailed assay of     immune cell activation and the various expression of miRNA will be evaluated in patients of     multiple trauma on day 1 and day 4.      Additionally, clinical parameters of organ function, current infection markers as CRP and     Procalcitonin, cardiovascular function such as Indocyanin clearance and hemodynamic measures     delivered with PiCCO-system and heart rate variability will be assessed. Parameters of local     tissue perfusion will be measured with transcutaneous laser doppler.   "
138428|NCT01472939|"     The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor     agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in     subjects with GERD who have persistent symptoms while on PPI therapy.   "
138429|NCT01472926|"     A pilot evaluation of tenecteplase compared to alteplase in acute ischaemic stroke patients     currently eligible for intravenous alteplase treatment in a prospective, randomised, blinded     outcome evaluation clinical trial using brain imaging as a biomarker.   "
138430|NCT01472913|"     The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss,     pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on     Range Of Movement (ROM) and strength is examined.   "
138431|NCT01472900|"     Acne is one of the most common conditions that patients seek for help in dermatological     clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics     ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a     satisfying result but not to every patient. Some patients are not well respond to     conventional therapy while some patients are unable to tolerate side effects of the     treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and     lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and     infrared lasers have been found to be useful in treating active inflammatory acne.     Although,pain ,downtime and poor response of comedonal acne are limitations of those lights     and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal     effects is our laser of interest to seek for its efficacy in the treatment of inflammatory     acne.   "
138432|NCT01472887|"     Primary Objective:      Participants achieving an Objective Response Rate      Secondary Objective:        -  Progression Free Survival        -  Overall Survival        -  Response Duration        -  Safety   "
138464|NCT01472471|"     Oxidative stress is seen in children with asthma, but is hard to measure. The investigators     exploring the utility of using a commercially available assay to measure oxidative stress in     the urine in asthmatics. Additionally, the investigators will attempt to prove that oxidative     stress is higher in children with acute asthma compared to those with stable asthma and that     this stress is also higher in children with more severe clinical asthma exacerbations     compared to less severe ones.   "
138433|NCT01472874|"     Hypothesis: The investigators postulate that patients with Wilson disease who are     asymptomatic or who have been effectively treated for their symptoms and are in a maintenance     phase therapy can be safely and effectively treated with a single daily dosage of the     chelating agent trientine.      Specific Aims: To demonstrate that a single daily treatment with trientine is as effective or     better than a patient's current maintenance therapy. This will be accomplished by performance     of a case control prospective study of patients on their prior therapy, and during a period     of treatment with a single weight based dose regimen of trientine.      The primary endpoint for this study is the demonstration of equivalence to a patient's prior     therapy. Secondary endpoints include: 1) demonstration of stability or improvement in     parameters of copper metabolism; 2) improvement in adherence to therapy; 3) no progression of     liver disease (defined by changes in synthetic function, albumin and INR, and fibrosis by     Fibrotest).   "
138434|NCT01472861|"     The purpose of this study is to determine if the use of Autologous Endometrial Coculture     (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves     pregnancy outcome.   "
138435|NCT01472848|"     This study examines whether a gradual increase of dose improves the gastrointestinal     tolerability (nausea and vomiting) of PF05212389   "
138436|NCT01472835|"     Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is     well-documented that the reference standard for identifying a pain generator is a low-volume     block performed with local anesthetic, with or without steroid. Many factors may increase the     false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of     sedation is the most controversial and remediable. Proponents of sedation argue that it has     little effect on the rate of positive diagnostic blocks, and may even reduce the     false-negative rate. The purpose of this study is to determine the effect of intravenous     sedation on pain relief and the false-positive rate after diagnostic nerve blocks.   "
138437|NCT01472822|"     Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly     adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty,     sweet, sour, astringent, and bitter. It has also been shown to have various effects on the     anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system,     endocrine system, and stress protect. Therefore, this study is designed to evaluate the     efficacy and safety on KO of Omija extract.   "
138438|NCT01472809|"     The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2)     the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to     the body) in the healthy and diabetic subject.   "
138439|NCT01472796|"     In this research study, the goal is to find out if a currently FDA-approved medication called     Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and     improve heart function in the African American population. High blood pressure occurs earlier     in life in African Americans, is more severe, and is associated with greater organ damage in     relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in     the African American population. Research has shown that there may be a link between low     Vitamin D levels and the ability of high blood pressure medications to be fully effective.   "
138440|NCT01472783|"     The main purpose of this study is to investigate the effect of veliparib in ovarian cancer     patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.   "
138441|NCT01472770|"     The present study aims to investigate the efficacy and safety of the combination of     capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic     colorectal cancer.   "
138442|NCT01472757|"     The purpose of the study is to evaluate the clinical efficacy of three doses of VR506     delivered via a new dry powder inhaler for the treatment of asthma.   "
138443|NCT01472744|"     The investigators propose to test the hypothesis that a six-month intervention of combined     fitness and cognitive training in the form of dancing will have a significant positive effect     on a variety of executive control and memory processes as well as brain structure and     function as compared to a non-aerobic strength and balance control/comparison group.     Additionally, these two groups will be compared to walking groups in which one of the walking     groups will also be provided with a daily, liquid, milk-based nutritional supplement.   "
138476|NCT01472315|"     The purposes of this study are to evaluate the degree and duration of medroxyprogesterone     acetate effect as well as tolerability in postmenopausal women with nasal continuous positive     airway pressure (CPAP) treated sleep apnea and to compare the effects with nasal CPAP.   "
138444|NCT01472731|"     Brain tumors account for only 2% of all cancers but result in a disproportionate share of     cancer morbidity and mortality. The five-year survival rates for the most common histologic     subtypes, anaplastic astrocytoma and glioblastoma (glioblastoma multiforme, GBM), are 30% and     10%, respectively.      Drugs affecting transforming growth factor-β (TGF-β) might be of great interest for malignant     glioma treatment. TGF-β is an oncogenic factor in advanced tumors where it induces     proliferation, angiogenesis, invasion, and metastasis as well as suppresses the antitumoral     immune response. In addition TGF-β and its TGF-β receptors, TβRI and TβRII, are overexpressed     in GBMs. TGF-β signaling is involved in multiple steps of GBM development. GC1008 is an     antibody that is capable of neutralizing TGF-β and may therefore offer a new treatment option     for patients with malignant glioma.      For therapeutic success, it may be essential for GC1008 to reach the target site, in this     case located in the brain. We will be able to prove this with 89Zr-GC1008 PET imaging. This     imaging method also allows quantification of the amount of GC1008 reaching the tumor.      This study consists of 2 parts. In part 1, patients with a suspicion of a malignant glioma     undergo an 89Zr-GC1008 PET scan before standard (surgical)treatment. In part 2, patients with     relapsed malignant glioma will undergo an 89Zr-GC1008 PET scan and will be treated with     GC1008 in a phase II study as there is no standard treatment for these patients.      We hypothesize that GC1008 uptake in brain tumors can be visualized and quantified using the     89Zr-GC1008 PET scan and GC1008 might offer a new treatment option for patients with relapsed     malignant gliomas.   "
138482|NCT01472237|"     The purpose of this study is to determine whether a modification of the diet of malnourished     patients admitted for heart failure is beneficial in term of mortality,hospitalizations and     quality of life.   "
138445|NCT01472718|"     200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and     having a high thrombotic burden at coronary angiography, defined as the presence of a     thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main     objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or     manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with     angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1)     rate of complete ST-segment elevation resolution at 60 minutes after the end of the     procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance     imaging (DE-MRI) at 3 months after the index procedure.      Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct     transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.   "
138446|NCT01472705|"     This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with     biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer     through 3 years of follow-up.   "
138447|NCT01472692|"     High normal blood pressure, also called prehypertension, is a significant problem. High uric     acid in the blood, the same thing that causes gout, may cause higher blood pressures. The     investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood     pressure and stiffness of the main blood vessels and see if lowering uric acid has any     effect.   "
138448|NCT01472679|"     The purpose of this study is to evaluate whether body composition is associated with a higher     risk of mortality in subjects ≥ 65 years.   "
138449|NCT01472666|"     Dairy food contains a large amount of long-chain saturated fat, which traditionally has been     linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a     more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids     (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and     in particular whey proteins have been shown to have a beneficial effect on glucose disposal     as well as anti-inflammatory properties. Therefore dairy products have a potential role in     the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data     from intervention studies are lacking.      Aims of this project is to explore and understand the influence on human health of both     medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well     as their interaction and potential positive synergy on the MeS.      The investigators hypothesize that whey protein and medium-chain saturated fatty acids     improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory     stress in humans and that they possess preventive effects on the risk of developing CVD and     type 2 diabetes mellitus (T2DM).      A total of 64 people with MeS or abdominal obesity will be included. The design is a     randomized double-blinded, controlled parallel diet-intervention trial.      Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of     either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA +     whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets     with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to     integrate the test foods in their habitual diet, which also continues unchanged. The     subjects' energy intake is matched so they are kept weight stable throughout the study.   "
138450|NCT01472653|"     The therapy of patients with locally advanced head and neck cancer will be adjusted to the     grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e.     either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy     (radiotherapy and Cisplatin.   "
138451|NCT01472640|"     Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic control     in patients with the combination of T2D and CHF is complicated and the currently available     treatments have proven to be inadequate in clinical trials.      Objectives To investigate the effect of Liraglutide compared to placebo on left ventricular     ejection fraction (LVEF) in CHF patients with and without T2D.      Multicenter, randomized, double blind study of 240 patients with documented systolic CHF (50%     with T2DM) will be randomised. The effect of Liraglutide on left ventricular systolic and     diastolic function will be evaluated by advanced echocardiography      Primary outcome parameter is change in LVEF from visit 1 to week 24.   "
138452|NCT01472627|"     The purpose of this study is to better understand what effects Bortezomib, a drug used for     multiple myeloma therapy, has on the immune system.   "
138453|NCT01472614|"     This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and     safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile,     and adiponectin in subjects with type-2 diabetes mellitus.   "
138454|NCT01472601|"     This study is a parallel translational study of a Randomized Phase III trial Investigating     the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as     Adjuvant Therapy for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol     NCCCTS-467) . Patients participating in the trial will be provided with the informed consent     of this parallel study, and peripheral blood and tumor tissue of those who signed the consent     will be collected for germline polymorphism analysis and gene expression profile study .   "
138569|NCT01471002|"     The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of     renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial     nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or     recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).   "
138463|NCT01472484|"     Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have     the potential to alleviate iron bioavailability problems associated with PA. These plants     have normal phosphate levels, but reduced PA phosphate due to various modifications of the     biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of     them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion     and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA     concentration without any defects in terms of growth and yield.      Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the     development of a variety which has the potential to improve the iron status of bean consuming     populations.      The following study will evaluate the relative impact of PA and PP on iron absorption from     beans by comparing iron absorption from four different bean varieties. Iron absorption from a     bean with normal PA concentration and high PP concentration will be compared to iron     absorption from a bean with normal PA and low PP concentration as well as to two lpa     varieties, one with high and one with low PP concentration.   "
138483|NCT01472224|"     This study investigates the ability of ultrasound to measure the volume of a brain hemorrhage     in the acute phase after hospital admission.      It is known that approximately 30% of patients admitted with a brain hemorrhage will suffer     from enlargement of the hematoma within the first hours after admission.      In this study the investigators measure the volume of the hematoma every 30 minutes up to 6     hours after admission and every 2 hours between 6-12 hours.   "
138455|NCT01472588|"     Obesity is a significant and growing problem in the US that negatively impacts health and     well-being of racial and ethnic minorities, people of low socioeconomic status, and persons     living in rural communities and in the South. Obesity is a major concern in Arkansas, where     the obesity rate for adults is higher than the rate for other adults in the nation. However     effective weight loss programs are not typically available in these communities. Research has     shown that the Diabetes Prevention Program (DPP) lifestyle intervention is effective in     promoting weight loss in high risk individuals through changes in diet and physical activity     that significantly reduce the chances of type 2 diabetes. Effective methods are desperately     needed to translate the DPP to community settings, where obesity is a compelling public     health burden. A major step in translating the DPP is to examine the efficacy of health     professionals and community health workers (CHWs) in delivering the program in real-world     settings. This is an important issue from the perspective of how evidence-based weight loss     interventions can be provided to underserved, and resource constrained communities that     typically may not have access to trained professionals for program delivery. The current     project is a 5 year randomized controlled trial that examines DPP delivery and weight     outcomes for individuals randomly assigned to either: (1) the DPP intervention delivered by     CHWs or (2) the DPP intervention delivered by health professionals or (3) the Self Help     condition. The study population consists of overweight adults (body mass index (BMI) > 25)     who reside in communities with a high proportion of African Americans. Primary outcome is     change in body weight at 16 months. Cost effectiveness and lifestyle behaviors are also     evaluated.   "
138456|NCT01472575|"     This project aims to assess the impact of rotavirus vaccine introduction on severe     gastroenteritis in South Australian children. Prevalence of rotavirus coded hospitalisations     and all-cause gastroenteritis hospitalisations will be compared for a two year period prior     to introduction of the vaccine and a two year period following introduction of the vaccine.     Severity of rotavirus coded admissions during the periods will also be assessed.      Hypotheses:        1. Introduction of the rotavirus vaccine will result in an 80% reduction in          hospitalisations for rotavirus positive gastroenteritis (ICD code A0.80) in children          less than two years of age.        2. Introduction of rotavirus vaccine will result in an 80% reduction in Paediatric          Emergency presentations for rotavirus positive gastroenteritis in children under two          years of age.        3. Introduction of the rotavirus vaccine will result in a 50% reduction in hospitalisations          for all cause gastroenteritis (ICD codes A0.00-A0.90) in children less than two years of          age.        4. Introduction of the rotavirus vaccine will result in a 50% reduction in Paediatric          Emergency presentations for all cause gastroenteritis in children less than two years of          age.        5. Introduction of rotavirus vaccine will result in a reduction in hospitalisation and          Paediatric Emergency presentations in children aged four and five years with rotavirus          positive gastroenteritis (unvaccinated cohort).        6. There will be no difference in severity of disease as scored by the Vesikari and/or          clark severity score prior to and post introduction of rotavirus vaccine   "
138457|NCT01472562|"     This is a phase II, multicenter study to determine the efficacy and safety of first-line     lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received     no prior systemic therapy.   "
138458|NCT01472549|"     The investigators propose a randomized controlled clinical trial to determine the comparative     effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for     preventing surgical site infections at cesarean section. While estimates vary, surgical site     infections complicate up to 5 - 10% of all cesarean sections and result in significant human     suffering and excess health care costs. Interventions such as preoperative antibiotic     prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high.     There is therefore a great need to identify and test other potential interventions to further     reduce these infections.      The skin is a major source of pathogens that cause surgical site infection. Therefore,     optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical     site infections. There is paucity of evidence to guide the choice of antiseptic for skin     preparation at cesarean section. To date, only two underpowered trials have been published     comparing two methods of preoperative skin preparation at cesarean section. A recent     randomized trial in adults undergoing clean-contaminated mostly general surgical procedures     demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol     when compared to the more commonly used povidone-iodine. While it is plausible that findings     from trials in other clean-contaminated surgical procedures may apply to cesarean sections,     physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related     infections and the hormone-mediated immune-modulation in pregnancy make the validity of such     extrapolation uncertain.      The study has the following specific aims:      Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation     at cesarean section significantly reduces surgical site infections compared to     iodine-alcohol.      Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin     preparation at cesarean section significantly reduces bacterial contamination at the surgical     site compared to iodine-alcohol.      Secondary Aim 2: To determine clinical outcomes and medical costs associated with     cesarean-related infections and quantify potential cost savings attributable to use of     chlorhexidine-alcohol for preoperative skin preparation at cesarean section.   "
138459|NCT01472536|"     Much of community transmission of seasonal and pandemic influenza occurs in younger     individuals, because of their susceptibility and their social interaction     patterns.Universities are places where transmission of influenza is facilitated because of     the age of individuals involved, their close contact with each other, and low vaccination     coverage. Staying home when you are sick (i.e., voluntary sequestration) has been identified     as one of the most efficient ways to reduce influenza transmission, but there are still     insufficient data on the effects of social distancing to be able to make recommendations for     future pandemics or even outbreaks of seasonal influenza.      The investigators are conducting a study on the effect of voluntary sequestration during     illness on the transmission of influenza among social networks in University residence     housing units at the University of Michigan. The sequestration interventions will be carried     out during a period of influenza transmission that is defined by surveillance conducted at     the University Health Service. Data will be collected on use of the interventions and the     occurrence of influenza and other illnesses. In all selected residence halls, specimens will     be collected when illness meeting a case definition for influenza-like illness occurs.      This study in a university population will evaluate the acceptability and magnitude of effect     that can be expected from such an intervention, and determine the number of days that     sequestration should be practiced.   "
138460|NCT01472523|"     A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the     presence of trisomies using a novel method.   "
138461|NCT01472510|"     This study is designed to confirm that the investigational drug Ranibizumab given by     injection into the eye is safe and effective to use in people with diabetic macular edema     (DME).   "
138570|NCT01470989|"     This was an 18-month, multi-center, open-label, clinical extension study. Patients completing     earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated     in this combined extension 3 study for any new gouty arthritis flare on demand with one     subcutaneous (s.c.) injection of canakinumab 150 mg.   "
138465|NCT01472458|"     The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on     using innovative knowledge translation strategies to improve appropriate neuroprognostication     for survivors of cardiac arrest and prevent premature termination of life sustaining     therapies. This is important because any early gains achieved during resuscitation will be     nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate     prognostic information. An effective translation strategy for neuroprognostication will     result in improved physician adherence to evidence-based medicine and an increase in the     proportion of patients surviving to achieve a good neurological outcome following cardiac     arrest.   "
138466|NCT01472445|"     This is a research study of the effect of Vitamin D on breast cancer. We hope to learn     whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that     affect its growth. We believe some of these characteristics may be influenced by body weight.   "
138467|NCT01472432|"     A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4     months of vildagliptin on healing of chronic ulcers in type 2 diabetes.   "
138468|NCT01472419|"     Esophageal squamous cell carcinoma is considerably more prevalent in East Asia. Despite of     relatively high prevalence of esophageal SCC, prognosis is very poor with limited options of     effective chemotherapy regimens. We attempted to identify favorable subgroups of patient who     are likely to benefit from 5- fluorouracil/cisplatin(FP) or capecitabine/cisplatin (XP)     chemotherapy as first-line treatment.Between January 2000 to December 2010, 239 patients were     diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line     chemotherapy. Clinicopathologic variables and treatment outcome were retrospectively     collected. we analysis treatment outcome of palliative chemotherapy in metastatic esophageal     squamous cell carcinoma and make prognostic scoring system. The present study represents the     largest series to analyze the treatment outcome of FP/XP chemotherapy in metastatic SCC.     Risk-adapted stratification of treatment for subgroup of metastatic SCC patients should be     actively pursued.   "
138469|NCT01472406|"     This clinical trial is a feasibility study to assess the performance of an Artificial     Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with     type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San     Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System     (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is     controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety     algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20     adults subjects aged 21 to 65 years old.   "
138470|NCT01472393|"     Animal, in vitro and small-scale studies have suggested that creatine supplementation may     augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine     supplementation protocol on bone mass in postmenopausal women.   "
138471|NCT01472380|"     Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an     inhibitor of CYP2B6. This study will evaluate the effect of multiple doses of fenofibric acid     at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult subjects.   "
138472|NCT01472367|"     The purpose of the study is to assess the safety of the addition of sitagliptin, and its     effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients     requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with     type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy (alone     or in combination with insulin). The primary hypothesis is that the addition of sitagliptin     reduces A1C more than the addition of placebo after 20 weeks of treatment. Participants who     complete the 20-week base period of the study may choose to participate in the extension     period of the study and continue on or off treatment assigned during the base period for an     additional 34 weeks.   "
138473|NCT01472354|"     The purpose of the LEAP-C (learning, experiencing and preparing for hepatitis C treatment)     study is to see if a brief (4-week) small group intervention will help people with HIV/HCV     co-infection make an informed decision about Hepatitis C treatment.   "
138474|NCT01472341|"     The purpose of this study is to evaluate the degree of beta-cell dysfunction among     participants with type 2 diabetes and the association between beta-cell dysfunction and     demographic, clinical, and treatment variables.   "
138477|NCT01472302|"     Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like     PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU     patients. The investigators hypothesized that using ASV from the beginning of intubation can     reduce the total duration of MV and LOS in the ICU when compared to conventional modes such     as PCV+PSV   "
138478|NCT01472289|"     The purpose of this study is to evaluate the safety and efficacy of the concentrated     autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia     patients.   "
138479|NCT01472276|"     Web- or internet-based programs have the potential to induce and, possibly, help to sustain,     significant lifestyle modification. This study will evaluate the effect of a unique     interactive web-based behaviour change program on weight loss and cardiovascular risk factors     in people who are overweight or obese and at high risk of cardiovascular disease.   "
138480|NCT01472263|"     In this study the investigators are going to evaluate the efficacy pentoxifyline in HTLV-1     patients with neurological diseases: HAM/TSP or neurogenic bladder. In some laboratory     experiments the investigators observed that this drug had the capacity to reduce the immune     response in HTLV-1 infected cells. Since the exacerbated immune response is know to cause     neurological disease in patients with HTLV-1 the investigators hope that pentoxifyline can     alleviate symptoms and delay the progress of HAM/TSP in patients.   "
138481|NCT01472250|"     This is a multi-center, prospective and observational clinical study. Eligible patients will     accept generalized chemotherapy according to the investigator's assessment. Information     related to the treatment, including medication, disease condition, expenses, etc. will be     periodically collected. Follow-up at 2-month intervals will be periodically performed to     continually collect information about the disease progression, subsequent treatment and     survival until death or completion of the study.      Recruited patients will fill out questionnaires about quality of life before initiation of     treatment, at Cycle 3 and completion of first-line treatment.   "
138484|NCT01472211|"     The overall aim of this trial is to determine whether the use of the household-based water     treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status     and health status of vulnerable populations in developing country rural settings with poor     access to potable water.      To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc     enriched water) a double blind controlled field efficacy trial will take place over a period     of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to     attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc     enriching filter), placebo (filter) and control group (disinfection tables). During the trial     the following outcomes will be monitored: zinc status and growth rate of the participating     children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy     sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment     of water, and modality and consistency of use of the LSF-device by the study population.      The study hypotheses are: 1) the use of the LSF-device will reduce microbiological     contamination of the household water, 2) the use of the LSF-device will increase zinc intakes     and serum zinc concentration in preschool children, 3) the use of the LSF-device will     increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1     and 2 will improve growth and lower frequency and length of diarrhea episodes in     participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy     outcome and lower frequency and length of diarrhea episodes in participating pregnant women,     6) the use of the LSF-device will lower frequency and length of diarrhea episodes in     participating households members.   "
138485|NCT01472198|"     This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination     with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be     comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment     phase.   "
138486|NCT01472185|"     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to     determine the effect of ranolazine when given as monotherapy on glycemic control in subjects     with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise     alone and who are treatment naive to antihyperglycemic therapy or have not received     antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24 weeks)     prior to screening, and to characterize the relationship between HbA1c reduction and other     glycemic parameters in subjects with T2DM.   "
138487|NCT01472172|"     The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe     during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding     intensity.   "
138488|NCT01472159|"     The purpose of this 2-year randomized controlled trial (RCT) is to implement and evaluate a     family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained     continuous glucose monitoring (CGM) use in youth with type 1 diabetes (T1D). We hypothesize     that CGM implemented with a family-focused, behavioral teamwork intervention will result in     sustained CGM use and greater improvement in A1c compared to routine implementation of CGM.   "
138489|NCT01472146|"     The purpose of this study is to evaluate the association of zoledronic acid with standard     treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast     cancer HER 2 positive.   "
138504|NCT01471847|"     This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients     that have locally advanced or metastatic HER2+ breast cancer. The first part (phase Ib) will     investigate the MTD/ RP2D of the combination therapy of BEZ235 BID and weekly trastuzumab     using a Bayesian model. Once MTD/ RP2D is established the second part (phase II) will start.     Phase II will evaluate the efficacy and the safety of weekly trastuzumab plus BEZ235 BID     compared to capecitabine and lapatinib.   "
138505|NCT01471834|"     The purpose of this clinical investigation is to verify the efficacy and safety of the CVRx     Barostim Neo System in the treatment of resistant hypertension.   "
138506|NCT01471821|"     This is a prospective, open controlled trial in which HIV-1 with viral suppression patients     will be randomized to continue with their current treatment (lopinavir/ritonavir plus     emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or     to simplify to lopinavir/ritonavir plus lamivudine.      Randomization will be stratified according to the values of nadir CD4 and time of viral     suppression.   "
138490|NCT01472133|"     Continuous accurate unobtrusive respiratory rate monitoring may lead to improved patient     outcomes, as respiratory rate is thought to be a sensitive marker of patient deterioration.     Currently systems are not suitable for long term monitoring, particularly in ambulant     patients as they are too restrictive. To ensure that our algorithms are suitable for use in a     clinical context we need to demonstrate their performance not only in the optimal situation,     healthy volunteers at rest, but also in more challenging situations such as where the person     being monitored is moving and also in patients who have conditions which may affect their     physiology in such a way that the accuracy of the respiration rate estimation may be     affected.      No previous study has systematically tested algorithms deriving respiratory rate from either     the ECG or the photoplethysmography (PPG) waveforms in a real -world setting.      The algorithms work by looking for changes in intervals between heartbeats and also changes     in the sizes of the ECG and PPG waveforms, both of which may be caused by respiration. These     changes tend to diminish with increasing age and also conditions which alter the chest     movement and cardiac reflexes. Thus it is important to test our algorithms' accuracy in     participants exhibiting these conditions. It is also important to ensure that the     calculations of respiratory rate are accurate across a range of heart rates and respiratory     rates. Our testing covers all these variables.   "
138491|NCT01472120|"     In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1     and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in     various metabolic disorders such as obesity and type 2 diabetes mellitus.   "
138492|NCT01472003|"     This is an open label study designed to evaluate the biodistribution and imaging     characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.   "
138493|NCT01471990|"     The purpose of this study is to examine and compare the effect of pituitary adenylate     cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on     intracranial arteries and neuronal activity in patients with migraine without aura using a     high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and     functional MRI (fMRI).      MRA will be used to detect changes in intracranial artery circumferences before and after     PACAP38 and VIP.      fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal     (BOLD-signal).      PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific     drug sumatriptan will be given to relieve pain and the effect will also be registered using     MRA and fMRI.   "
138494|NCT01471977|"     It was hypothesized that tuberculosis patients receiving multiple interventions like     educations, counseling and default tracing along with DOTS were more likely to adhere to     tuberculosis treatment as compared to few interventions or DOTS only.   "
138495|NCT01471964|"     This phase I/II trial studies the side effects and the best dose of MLN8237 when given     together with erlotinib hydrochloride and to see how well it works in treating patients with     recurrent locally advanced or metastatic non-small cell lung cancer (NSCLC). MLN8237 and     erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth.   "
138496|NCT01471951|"     Embryo selection based on the use of morphometric parameters should increase the implantation     success rate.      One of the most important issues of Assisted Reproduction Technologies (ART) is the     possibility of multiple pregnancies which carries a significant risk for maternal-fetal     health. These risks can be reduced by restricting the number of embryos transferred.      To do this, it is essential to improve current techniques of embryo selection by developing     new tools that would allow the selection of the embryos with higher implantation potential.     In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy     for the embryo classification systems based on the use of the morphometric variables. The     investigators have also developed a profile of embryo implantation using these morphometric     variables. In this project the investigators intend to validate the clinical validity of this     new embryo classification system by conducting a prospective study of single embryo transfer     (SET) in young women at risk of multiple pregnancies.   "
138497|NCT01471938|"     The aim of the study is to apply and adapt device specific body composition formulas to     various ethnic groups. Bases are prediction equations that are generated in the clinical     investigation Generation of prediction equation to analyze body composition of adults based     on Bioelectrical Impedance Analysis (BIA). The study bears the code BCA-01.   "
138498|NCT01471925|"     A phase III, randomized, open-label, superiority study comparing the incremental product     esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the     treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm     (total of 188 patients).   "
138499|NCT01471912|"     In our experience, elongation of foveal tissue after macular hole surgery which was     undetectable by conventional time-domain optical coherence tomography was often observed on     spectral-domain optical coherence tomography images. Elongation of tissues inevitably induces     some degree of disorganization of tissue microstructure.      The purpose of the present study was to evaluate elongation profile of foveal tissue after     macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.   "
138500|NCT01471899|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different drugs in the treatment of patients diagnosed with moderate to severe back pain     treatment.   "
138501|NCT01471886|"     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two     different drugs in the treatment of patients diagnosed with moderate to severe back pain.   "
138502|NCT01471873|"     Primary objective of this study was to assess the intrasession, intersession and     interobserver variability of the Pentacam-derived posterior corneal elevation measurements in     keratoconus eyes and eyes that underwent Corneal Collagen Cross-liknking (CxL) treatment due     to progressive keratoconus.   "
138503|NCT01471860|"     The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx     Barostim Neo System in the treatment of patients with heart failure.   "
138507|NCT01471808|"     The purpose of this study is to investigate and evaluate the effects of different oral     antihyperglycaemic agents combined with short-term continuous subcutaneous insulin     infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin     combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type     2 diabetic patients.   "
138508|NCT01471795|"     Infections often occur after ventricular assist devices (VADs) are placed. These infections     can be very serious. The goal of this study is to understand why these infections occur.     Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect     the VAD. The investigators will collect cultures of your skin and nose before and after     surgery. The investigators will compare these bacteria to bacteria that cause infections.     Their genes will be compared to see which ones help the bacteria cause infection.   "
138509|NCT01471782|"     The purpose of this study is to determine the dose of the bispecific T cell engager     blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute     lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.   "
138510|NCT01471769|"     The purpose of this study is to evaluate if an educational video viewed during the Emergency     Department visit will improve parent knowledge of pain management, reduce parent anxiety, and     change their use of analgesics at-home after discharge from the Emergency Department.   "
138511|NCT01471756|"     The investigators seek to compare two techniques of removing pre-cancerous lesions from the     colon. The investigators also will compare two solutions used during the procedure to     determine if either solution allows for an improved removal of the tumors.   "
138512|NCT01471743|"     Surgical patients are high risk for post operative infections. These post operative     infections contribute to increased length of hospital stay, hospital costs and delay overall     recovery time thus decreasing the quality of life. Studies have reported post operative     complications ranging from 37% to 74%.1 The most costly complications include infectious     complications after major Gastrointestinal (GI) surgery including wound infections, abdominal     abscess, pneumonia, sepsis and anastomic leaks.2 Several studies have been conducted that     show a significant reduction in infectious complications and average length of stay when     treated with immunonutrition supplements.2-3 A review of similarly designed studies in a     different patient population indicate that post-operative infections can be reduced by an     average of 71% with immunonutrition.      This study seeks to investigate the effect of Impact Advanced Recovery ® in improving     surgical outcomes in patients receiving major gastrointestinal surgeries compared to a     standard supplement at James A. Haley Veterans' Hospital. Providing Impact Advanced Recovery     ® may decrease post-operative infectious complications, length of stay, and recovery time.      Hypothesis        1. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic          or colon resections) there will be a significant decrease of at least 60% in          post-operative infections as listed below for patients who consume 15 servings of Impact          Advanced Recovery® pre-operatively compared to patients who consume 15 servings of a          standard supplement.           Complications to be considered: anastomatic leak, post-op wound development, post-op          abdominal abscess, sepsis, pneumonia, post-op ileus, intestinal fistula, obstruction,          urinary tract infections, peritonitis or bowel necrosis.        2. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic          or colon resections) there will be a significant decrease in hospital and NPO days for          patients who consume 15 servings of Impact Advanced Recovery ® pre-operatively.   "
138536|NCT01471431|"     The objective of this study is to determine whether use of the spontaneous breathing trial     allows for earlier successful extubation of very low birth weight (VLBW) infants who are     intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).   "
138513|NCT01471730|"     Prospective, randomized, double blind trial. The rationale of the study is the concept that     fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that     prothrombin complexes and fibrinogen are available.The experimental hypothesis is that     cardiac surgery patients may be operated with no use of FFP and with a coagulation factors     replacement based on fibrinogen and prothrombin complexes (when needed).      Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive     blood transfusion, bleeding.      Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60     patients each   "
138514|NCT01471717|"     This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction     between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).   "
138515|NCT01471704|"     The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug     interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL     ER).   "
138516|NCT01471691|"     This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular     edema secondary to retinal vein occlusion in patients that have previously failed treatment     with other macular edema treatments including bevacizumab.   "
138517|NCT01471678|"     This study aims to determine the relative bioavailability of tamsulosin hydrochloride in a     fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg)     relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.2     mg tablets or capsules. Two fixed dose combination capsules will be tested; one will contain     tamsulosin hydrochloride pellets with a 15% enteric coating, and the other tamsulosin     hydrochloride pellets with a 10% enteric coat. In addition, two formulations of tamsulosin     hydrochloride will be tested in the co-administration with dutasteride 0.5 mg; a 0.2 mg oral     disintegrating tablet and a 0.2 mg hard shell capsule. This will be an open-label,     randomized, single dose, four-period crossover in healthy male subjects of North East Asian     ancestry. Subjects will receive single oral doses in four treatment periods, each separated     by a 5-10 day washout period. Blood samples for pharmacokinetic analysis will be taken at     regular intervals after dosing. Safety will be assessed by measurement of blood pressure,     heart rate and review of adverse events. The study will enrol approximately 30 healthy male     subjects to ensure that 24 complete the study.   "
138518|NCT01471665|"     The purpose of this study is to investigate the effect on repeat doses of GSK2190915 in     asthmatic patients with a high percentage of neutrophils in their sputum. GSK2190915 will be     given as an add on to current therapy, and its effects on the percentage of sputum     neutrophils in the patients will be assessed.   "
138519|NCT01471652|"     The pathogenesis of chronic fatigue syndrome (CFS) is poorly understood and no effective     therapy has been developed. Recent studies suggest that a preceding viral infection causes     mitochondrial dysfunction of the brain and skeletal muscle of genetically susceptible     individuals. There is no specific laboratory test to identify patients with CFS. However,     certain clinical manifestations are similar to those seen in mitochondrial disorders. Both     patients with mitochondrial disorders and CFS manifest elevated serum lactate levels after     exercise, and demonstrate elevated brain cerebrospinal fluid levels and decreased brain     glutathione levels on nuclear magnetic resonance (NMR) spectroscopy.      Therapy consisting of daily conditioning exercise, dietary recommendations, and nutraceutical     supplements (ENT) has been show to be beneficial in treating patients with mitochondrial     disorders. Similar therapy has been instituted in individual patients with CFS and has been     shown to also improve their clinical conditions.      A placebo-controlled trial will be undertaken in 24 CFS patients aged 25-55. Patients     fulfilling the CDC criteria for CFS will participate in this 6 month study. Other medical     causes for fatigue will be excluded. Half the patients will receive treatment consisting of     daily conditioning exercise plus nutraceutical supplements (ENT), that has been shown to be     beneficial for patients with mitochondrial dysfunction, while the other half will receive     daily conditioning exercise and placebo tablets. Response to ENT will be evaluated by maximum     oxygen consumption (VO2max) and circulating lactate levels during & after treadmill exercise,     a 6-minute walk test, and a fatigue questionnaire. In addition, whether ENT corrects the     elevated brain cerebrospinal fluid levels and decreased brain glutathione levels will be     measured. To ensure compliance to therapy patients will be monitored frequently. The     objective of this study is to assess the safety and efficacy of ENT and whether ENT leads to     sustained improvement of CFS patients compared to their baseline status, and compared to an     exercised group of patients not receiving supplements.   "
138531|NCT01471496|"     The purpose of this study is to determine whether prophylactic injection therapy reduces     recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent     bleeding.   "
138520|NCT01471639|"     The purpose of this study is to determine the effectiveness, the safety, and the tolerability     of intranasal ketorolac (Sprix) in relieving acute pain in adults ages 18-64 who come to the     ED seeking care. Considering all ED visits, pain is the most common chief complaint. Giving     intranasal ketorolac (Sprix) after stomach and dental surgeries has been shown to be safe and     effective, but no studies have investigated the use of intranasal ketorolac (Sprix) for the     treatment of acute pain in the ED.      Ketorolac (Sprix) has several advantages over other drugs commonly given for pain, including     opioids. Ketorolac (Sprix) is non-addicting and has fewer side effects than opioids. The     administration of ketorolac (Sprix) by other methods, such as IV, intramuscular shot, and     oral pill form, has been shown to be safe and effective in treating acute pain.      This study is being done to find out if giving ketorolac (Sprix) as a single dose nasal spray     will have the same benefit in decreasing patient's pain.   "
138521|NCT01471626|"     The purpose of this study is to develop an efficient home-based polysomnography device, which     allows, through GPRS,continuous real-time monitoring from the sleep lab based in the     hospital, in order to decrease the failure rate of home-based recordings.   "
138522|NCT01471613|"     The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical     cord blood mononuclear cell transplant, and the combination in the treatment of acute and     subacute spinal cord injury   "
138534|NCT01471457|"     The primary objective of this prospective, randomized, controlled study is to assess the     effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use     pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for     >1 year are recruited in to the study and randomized to using Trimo-San gel daily or not     using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis     (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect     of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary     fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the     rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain,     but will have a positive effect on the subjective symptoms experienced by women wearing     pessaries.   "
138714|NCT01469078|"     The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000     (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney     Disease on Dialysis Therapy (CKD-5D).   "
138523|NCT01471600|"     In several national anaesthesia societies, clear fluids are allowed up to 2 hours before     general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting     remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink     reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of     this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper     endoscopy without emergency. The expected efficacy is a reduction of the preoperative     discomfort. The investigators thus propose a randomised prospective open-label study to     assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy     without emergency. Study compare two groups : group drink (200 ml of fruit juice without     pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group     overnight fasting.Discomfort was measured at 2 hours before GA (H-2), just before GA (H0)     and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness,     nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by     dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual     fluid and acidity.The main aim of this study was to assess in patients referred for upper     endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic     discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes,     gastric acidity and incidence of side effects. 118 patients will be included in the study. A     stratification will be made on the type of endoscopy.   "
138524|NCT01471587|"     Skeletal muscle is composed of two fibre types which are intertwined. Skeletal muscle     weakness, particularly of the walking muscles, is an important complication of Chronic     Obstructive Pulmonary Disease (COPD) but so far the investigators do not know what mechanisms     drive the process.      All existing studies have investigated signalling pathways in the whole muscle so they have     been forced to consider type I and type II fibres together. It is possible that disease     selectively affects one fibre type, most likely type I fibres which are in fact lost in COPD     patients. For this reason mechanisms of disease may have been overlooked by current studies.      The applicants have acquired the technology which allows type I and type II fibres in a     muscle specimen to be split (by laser capture microdissection) and so signalling pathways can     be assessed separately in type II and type I fibres which is what this proposal sets out to     do.      The proposal therefore aims to capture well characterised clinical data from 60 COPD patients     and 20 age matched controls, from whom a biopsy of the main walking muscle, the quadriceps,     will be taken. In the samples the investigators will assess at a fibre specific level     inflammatory signalling. Surplus material will be retained for subsequent fibre specific     analysis.   "
138525|NCT01471574|"     The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir     plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients     coinfected with HIV   "
138526|NCT01471561|"     This is a retrospective study to determine if rates of osmolarity and dry eye disease     symptoms increase following cataract surgery.   "
138527|NCT01471548|"     The purpose of in this study is to assess the safety profile and estimate the maximum     tolerated dose of TKI258 in Japanese patients.   "
138528|NCT01471535|"     Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of     chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive     carriers.      The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface     antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine     aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would     not generally be considered candidates for therapy.   "
138529|NCT01471522|"     The purpose of the ISCHEMIA trial is to determine the best management strategy for     higher-risk patients with stable ischemic heart disease. This is a multicenter randomized     controlled trial with a target enrollment of ~5000 patients with at least moderate ischemia     on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV)     with cardiac catheterization (cath) followed by revascularization plus optimal medical     therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization     reserved for those who fail OMT.      SPECIFIC AIMS      A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial     invasive strategy of cardiac catheterization followed by optimal revascularization, if     feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular     death or nonfatal myocardial infarction in participants with SIHD and at least moderate     ischemia over an average follow-up of approximately 4 years compared with an initial     conservative strategy of OMT alone with catheterization reserved for failure of OMT. The     primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal myocardial     infarction.      B. Secondary Aims Major: To compare angina-related quality of life between groups. Other     secondary aims include: a) comparing the incidence of all-cause death; the components of the     primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or     hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke;     and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for     unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups; and     b) comparing health resource utilization, costs, and cost-effectiveness between groups.      Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac     catheterization Phase: Phase III      Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous     Coronary, other catheter-based interventions Phase: Phase III      Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III   "
138530|NCT01471509|"     The purpose of this study is to determine the effect of various foods and/or food substances     such as fats or proteins on the blood glucose and insulin concentrations in people with and     without type 2 diabetes.   "
138532|NCT01471483|"     Older woman with ovarian cancer have a worse prognosis compared to younger patients. However,     the reason is not known. Currently, the standard of care is to evaluate younger and older     patients with cancer the same way. However, older patients with cancer often have more     complicated issues to manage. For example, older patients often have other medical problems,     take more medications, and be dependent on others for help and transportation. Too often, the     medical team is unaware of these issues which can effect the patients care.      The purpose of this study is to apply a set of questions designed specifically for patients     with cancer who are older than 65 years of age. These questions are called a geriatric     assessment.      The investigators want to better understand which older patients with ovarian cancer will be     able to tolerate the chemotherapy and surgery and why. This study will also see if a     telephone call from a nurse who specializes in caring for older patients will improve patient     care. This study will determine how feasible it is to perform geriatric assessments and     telephone calls in patients with ovarian cancer.   "
138533|NCT01471470|"     The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and     bevacizumab are effective in the treatment of unresectable advanced gastric cancer.   "
138738|NCT01468753|"     To evaluate the acceptability, feasibility, and efficacy of vaginal insemination as a method     of conception in HIV discordant couples (female positive, male negative) desiring pregnancy     in Kisumu, Kenya   "
138537|NCT01471418|"     Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an     estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent     of the patients who seek care for one of these conditions, will go on to develop chronic     pain. The two most common TMD conditions include myofascial pain disorder and internal     derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical     presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam     or test to differentiate between these two conditions.      Internal derangement of the TMJ is a condition with disk displacement, pain, and dysfunction,     which may progress to localized osteoarthritis. Fortunately, this condition is self-limiting     for the majority of the patients afflicted, with a small minority progressing to advanced     joint destruction, disability and chronic pain.18 Currently there are no prognostic     indicators to identify these individuals. There are three hypothesis of degenerative TMJ     disease, they include: direct mechanical trauma, hypoxia reperfusion injuries, and neurogenic     inflammation. All involve parafunctional habits such as clenching or grinding by the patient     and a low-grade inflammatory response/synovitis. 18-fluorodeoxyglucose (18-FDG), a     radioisotope used with positron emission tomography (PET) and paired with a CT scan (PET/CT),     may have a role in imaging inflammation in arthritis as recently demonstrated in several     pilot studies involving osteoarthritis of the knee and shoulder. 18-FDG accumulates in areas     of increased metabolism, particularly activated leukocytes, as measured by increased     standardized uptake value.2 PET/CT offers the unique advantage of showing active disease     before anatomic damage is evident. Our hypothesis is that there is an increased uptake of     18-FDG on PET/CT in synovitis of the TMJ.   "
138538|NCT01471405|"     This non-interventional retrospective study aims to describe the therapeutic procedures and     modalities received by patients and the correlation to hormone status, during a one year     follow up from completion of the 2-79-52030-207 study.   "
138539|NCT01471392|"     The overall goal of the present study is to provide evidence of concordant test results using     the Identigene STD Test Collection Kit for self-collection and transport of specimens to a     qualified testing laboratory. It is expected that this method will aid in detection of CT and     NG and that offering a method of self-collection of a male urine or female vaginal swab     specimen will encourage testing for CT and NG and improve the overall detection of reporting     of these STDs by allowing persons who suspect they have the infection to be tested in a     discrete and confidential manner. The reporting of CT and NG are underestimated and many     subjects will not visit a clinic or obtain treatment if gone undetected. Thus, allowing a     self-collection kit that is more convenient may result in improved reporting, identification     of CT and NG positive individuals, and subsequent treatment to help prevent the spread of     these diseases.      The purpose of this study is to demonstrate that the Identigene STD Test Collection Kit and     labeled instructions for use instructions provide test results that are concordant (at least     95% or better) with test results obtained using the Gen-Probe APTIMA Combo 2 specimen     collection and transport methods performed under the supervision of a healthcare provider.     The laboratory technology and test method used for the IDTG-100.   "
138540|NCT01471379|"     Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for     treating irritable bowel syndrome (IBS) in women.      Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS.      Procedures: This study will observe patients treated with Savella® as well as patients     treated with a placebo (pill with no active drug). The investigators will monitor and compare     several patient and symptom related outcomes, as well as evaluate health related quality of     life, psychological distress and related psychosocial measures to determine if the addition     of Savella® improves clinical pain response as well as secondary outcomes including quality     of life.   "
138541|NCT01471366|"     Many patients complain of fishy breath, upset stomach, or heartburn when taking the     recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the     fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with     over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken     daily. The hypothesis of this study is that taking fish oil with milk will help lead to     better patient compliance with no difference in adverse effects versus other administration     methods.   "
138543|NCT01471340|"     The purpose of this study is to test the safety of DULERA. DULERA is a pressurized     metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol     in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the     inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps     to relax the muscles of the airways in the lungs, making it easier to breathe. In     combination, mometasone and formoterol are used for the treatment of asthma. This study will     evaluate whether participants taking a LABA in combination with an ICS in a single inhaler     have a different risk of having serious asthma events (hospitalization, intubation and death)     compared to participants taking an ICS alone.   "
138544|NCT01471327|"     SB-240563 is a fully humanized monoclonal antibody which is specific for human interleukin-5     (IL-5) and has been under development for severe refractory asthma. This study is the first     study in Japanese subjects. The purpose of this study is to evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of single dose SB-240563 administered     intravenously to Japanese healthy male subjects.   "
138545|NCT01471314|"     The purpose of this study is to examine migraineurs during spontaneous migraine attacks     without aura, using high resolution magnetic resonance imaging (MRI), to study following:        -  Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using          functional MRI (fMRI).        -  Changes in circumferences of intra- and extracranial arteries using MR-angiography          (MRA).        -  Changes in regional and global cerebral blood flow (CBF) using the arterial spin          labeling (ASL) method.      Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.      The migraine specific drug sumatriptan will be given to relieve pain and the effect will be     registered using MRA and fMRI if possible.   "
138546|NCT01471301|"     The purpose of this study is to evaluate ultrasound hands in patients with systemic lupus     erythematosus.   "
138547|NCT01471288|"     Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging     from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with     thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin.     TSH level returned to normal after discontinuation of the Carum carvi. This observation led     to a pilot study for evaluation of the effect of carum carvi on thyroid function.   "
138548|NCT01471275|"     With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi     decoction in treatment of obesity with type 2 diabetes, dyslipidemia   "
138549|NCT01471262|"     As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal     with an emerging aged population, which has a potential higher risk for complication and     worse long-term outcome. The investigators will be analyzing the liver function and outcome     after right or extended right hepatectomy in patients over 70 years old.   "
138551|NCT01471236|"     The purpose of this study is to determine the performance of the Agili-C implants. The study     hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and     cartilage-bone joint surface defects.   "
138552|NCT01471223|"     The purpose of the study is to estimate the incidence rates of Post-transplant     Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult     kidney-only transplant recipients treated with Belatacept, and compared the incidences to the     incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of     transplantation.   "
138553|NCT01471210|"     The purpose of the study is to assess the safety, tolerability, pharmacokinetics and     immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or     metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma   "
138554|NCT01471197|"     The purpose of this trial is to determine whether Ipilimumab will prolong survival when     compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.   "
138555|NCT01471184|"     The primary objective of this study is to assess the relative efficacy of Ectoin® Allergy Eye     Drops and Ectoine® Allergy Nasal Spray compared to placebo, by evaluating Total Nasal Symptom     Score (TNSS) and Total Ocular Symptom Score (TOSS).      The secondary objectives are :        -  To evaluate the relative efficacy of Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal          Spray compared to placebo by evaluating Total Non Nasal Symptom Score (TNNSS),          congestion symptom scores, red eye symptom scores, watery eye symptom scores, itchy eye          symptom scores, and by evaluating the mean cross-sectional area (MCA) using acoustic          rhinometry (AcR).        -  To assess the change from baseline (post-EEC from pre-EEC) in inflammatory parameters of          nasal secretions, comparing Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal Spray to          placebo at each post-treatment visit.   "
138556|NCT01471171|"     The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a     day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation     and dyspnoea at rest and during exercise after 3 weeks of treatment.   "
138557|NCT01471158|"     The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT®     after a single drop of each medication is administered to both eyes, in patients with     open-angled glaucoma or ocular hypertension.   "
138571|NCT01470976|"     The primary aim of the study is to investigate whether a goal-directed resuscitation therapy     in high-risk patients through cardiac index optimization using the LiDCO Rapid device reduces     complications after cardiac surgery. The hypothesis is that there are better outcomes when     achieving a cardiac index higher than 3L/min/m2 in those patients with an arterial lactate     higher than 1.5 mmol/L.   "
138558|NCT01471145|"     The aim of this project is to study brain functions of 20 heroin addicts (compared to brain     functions of 20 healthy controls) just before and during a three month extended release     naltrexone treatment using functional MRI and dopamine transporter SPECT.      The following hypotheses are tested:        -  XRNT modulates the fMRI response to drug cues in predetermined brain regions.        -  The expression of striatal transporters (assessed with SPECT) will decrease after a          three-month course of extended release naltrexone   "
138559|NCT01471132|"     The recurrence and metastasis of peritoneum is always the lethal consequence for gastric     cancer patients, and there is no effective therapy until now. It has been reported by     Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called     hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer     cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy,     HIPEC with combination regimen would have a brighter prospect. In this study, the     investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and     overall survival would be observed and evaluated.   "
138560|NCT01471119|"     To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult     patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults age     18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective SCORAD     from 10 to 40) are going to be enrolled in a randomized,double-blind,placebo-controlled     study.Sublingual Dermatophagoides Farinae Drops or placebo is given for 9 months in addition     to standard therapy.SCORAD,average anesis interval,rescue medicine and DLQI will be recorded.   "
138561|NCT01471106|"     The goal of this clinical research study is to learn if dasatinib can help prevent breast     cancer from developing in the unaffected breast.      Dasatinib is designed to decrease the activity of one or more proteins that are responsible     for the uncontrolled growth of tumor cells.   "
138562|NCT01471093|"     The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy     subjects.   "
138563|NCT01471080|"     In the past, the investigators often treated giant cavernous hemangiomas of the liver by     hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied     to cure this disease.But we can't get a clear answer about their effectiveness and safety.     Hence the investigators conduct this study to explore the effectiveness and efficiency of the     these two methods and compare their short to mid-term outcomes.   "
138575|NCT01470924|"     A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The     aim of this population-based study was to assess the results of reinduction treatment and     allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden     2003-2007.   "
138617|NCT01470365|"     This phase I trial studies the side effects and best dose of 3-dimensional conformal     radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients     with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells.     Palliative radiation therapy may help patients with recurrent tumors live more comfortably.   "
138758|NCT01468493|"     The purpose of this study is to determine whether the improved responsiveness to treatment     achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be     explained by CsA's inhibitory action on the circulating suPAR expression.   "
138564|NCT01471067|"     The goal of this clinical research study is to learn if it is safe and feasible to transplant     changed cord blood for patients with leukemia or lymphoma. Researchers also want to learn if     this can help to control the disease.      The cord blood will be changed to make use of sugar that is found in small amounts in blood     cells. It plays a role in signaling where in the body the transplanted cells should go to.     Adding more sugars to the cord blood cells in the laboratory is designed to help the cord     blood cells find their way faster to the bone marrow. This may help your blood counts to     recover faster. This process is called fucosylation.      Anti-thymocyte globulin (ATG) is a protein that removes immune cells that cause damage to the     body.      Clofarabine is designed to interfere with the growth and development of cancer cells.      Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which     may cause the cancer cells to die. This chemotherapy is also designed to block your body's     ability to reject the donor's bone marrow cells.      Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells     to die.      Mycophenolate mofetil (MMF) and tacrolimus are designed to block the donor cells from growing     and spreading in a way that could cause graft versus host disease (GVHD -- a condition in     which transplanted tissue attacks the recipient's body). This may help to prevent GVHD.      Rituximab is designed to attach to cancer cells, which may cause them to die.   "
138565|NCT01471054|"     To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and     compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema     after plaque radiotherapy of uveal melanoma.   "
138566|NCT01471041|"     The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in     achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as     prescribed.   "
138567|NCT01471028|"     The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect     to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver     decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing     additional survival data up to a maximum of 5 years that will be included, as available,     through VTI-208 study termination (after the last surviving enrolled subject completes Study     Day 91).      Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91.      Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function,     measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP)     up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days     28 and 91. Progression is defined as death or the first observed increase of at least 5     points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at     least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to     both End of Study Days 28 and 91 following Randomization.   "
138568|NCT01471015|"     Selective head cooling or whole body hypothermia has become the standard of care for neonatal     hypoxia-ischemia encephalopathy (HIE). Despite early intervention death or major     neurodevelopmental disability still occurs in nearly 50% of infants ≥ 36 weeks gestational     age (GA) treated with cooling. No additional therapies have proven to be efficacious in     further reducing brain injury and impairment for these high risk infants. Neuroprotective     strategies aimed at improving early childhood outcomes are still needed. An important area of     study includes therapies that may complement the neuroprotective effects of hypothermia and     promote neuronal regeneration, recovery and neurovascular remodeling. Among these therapies,     erythropoiesis stimulating agents (ESA) have been shown to provide neuroprotection, improving     short and long-term neurologic outcome in brain injury and HIE in neonatal and adult animal     models. Parallel with neuroprotective effects in experimental settings, recent small clinical     studies suggest improved outcomes after ESA administration in patients with severe traumatic     brain injury and HIE. ESA may work through several important mechanisms including reduced     inflammation, limited oxidative stress, decreased apoptosis and white matter injury, as well     as via pro-angiogenic and neurogenic properties.      Darbepoetin alfa (Darbe), a recombinant human erythropoietin (EPO)-derived molecule, has an     extended circulating half life and comparable biological activity to EPO, including     activation of the EPO receptor. The proposed study is a Phase I/II dose safety and     pharmacokinetic trial of early Darbe administered concurrent with hypothermia in human     newborn infants with moderate to severe birth asphyxia. The long-term objectives of the     proposed research are to reduce mortality and to decrease the risk of long-term disabilities     in infants with HIE who survive beyond the newborn period.   "
138572|NCT01470963|"     The purpose of this study is to examine whether the implementation of a referral template     will increase quality of health care delivered and the quality of health care co-operation.     The investigators intent to implement a referral template, at the level of the general     practitioner (GP), for the referral of patients within 4 separate diagnostic groups:        -  dyspepsia/upper GI symptoms        -  colonic cancer investigation/lower GI symptoms        -  chronic obstructive pulmonary disease (COPD)        -  chest pain      Local GP clinics will be randomised to use the referral template or to use standard referral     practice. Using a predefined set of quality criteria the investigators will score the process     of care in each patient, and compare intervention and control groups. In addition other     criteria will be collected and compared between the two groups, e.g.        -  time to diagnosis/treatment        -  quality of referral        -  more appropriate referrals        -  patient satisfaction (as measured by a questionnaire)      The investigators hypothesize that the implementation of a referral template will lead to a     measurable increase in the quality of health care delivered.   "
138573|NCT01470950|"     Atrogin-1 and muscle RING finger-1 are skeletal muscle specific genes, with ubiquitin ligase     activities, that are upregulated during muscle atrophy in mice. The Akt/GSK3 and Akt/mTOR     pathways are involved in muscle hypertrophy in mice. Recent studies by the investigators team     and others have demonstrated the implication of these signalling pathways in the control of     muscle mass in humans. However no study has yet investigated the involvement of these systems     in the early stages of spinal cord injury induced human skeletal muscle atrophy.      The investigators propose to investigate the level of expression of the different components     of the ubiquitin-proteasome system together with the level of expression and activity of the     Akt/mTOR and Akt/GSK3 signalling pathways after SCI in humans during the first months     following the injury.      A second aim of this project is to assess if a novel apparatus of electrical stimulation     which generate movements by closed-loop electrical muscle stimulation may improve strength     and muscle mass in these patients.      The patients will be recruited jointly at the Clinique Romande de Réadaptation (CRR) in Sion     and the Swiss paraplegic centre in Nottwil. They will be randomly divided into two groups, a     first group of patients will undergo a conventional treatment of rehabilitation while a     second set of patients will be treated using a brand new system of electro-stimulation called     MotionMaker TM. Biopsies will be obtained in the first weeks after admission; two other     biopsies will be taken respectively 3 and 6 months post-lesion.      Our results will provide an increased understanding of the molecular mechanisms contributing     to skeletal muscle atrophy during the early stages following SCI and a characterization of     the impact of endurance training in the no more voluntary innervated muscle. Moreover this     study will also investigate the potential improvement in the rehabilitation process by using     a new system of electro-stimulation.   "
138574|NCT01470937|"     This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control     in early Type 2 diabetes mellitus.   "
138576|NCT01470911|"     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of     the immune system caused by cytokine production. A substantial number of asthma patients do     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for     novel targeted therapies with improved specificity, tolerability, and compliance.      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting     early disease-causing mechanisms are a promising approach for the treatment of asthma. The     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and     has been shown to be necessary and sufficient for the production of cytokines interleukin     (IL)-4, IL-5, and IL-13. The active principle hgd40 of the investigational medicinal product     SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA     (deoxyribonucleic acid) zymes (antisense oligonucleotide). DNAzymes are catalytically active     nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3     mRNA hgd40 reduces specific cytokine production and thereby reduces key features of allergic     airway inflammation.      DNAzymes are completely generated by chemical synthesis and can be produced under Good     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,     i.e. they are not generated by use of any living organism including cell culture or bacteria.     The molecules are highly water-soluble and will be applied as solution directly in their     synthesized form.      The current study will evaluate the safety and tolerability of increasing single doses of     inhaled SB010 in healthy male subjects.   "
138577|NCT01470898|"     Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness.     Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably     help to shorten recovery time and reduce drug consumption. The aim of the study was to     investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative     anesthesia consumption.   "
138578|NCT01470885|"     Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a     systemic inflammatory response syndrome with significant morbidity and mortality in 20% of     patients. Part of endocrine function of pancreas would be affected in AP. Stress     hyperglycemia would explode at acute phase. So the investigators decide to follow up and     observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood     amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to     identify the die cutting between blood glucose level and acute pancreatitis, and makes     analysis of the diagnostic value.   "
138579|NCT01470859|"     Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the     first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous     clinical trial indicated that initial pramipexole owns advantage over levodopa regarding     motor complications, on the contrary, less adverse effect like freezing and severe somnolence     favors initial treatment of levodopa. Thus, it remains controversial that initiation of which     medication will be better for those patients with early PD.      Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can     represent the network activity of brain and severity of PD. Based on the literatures and our     previous data, the investigators hypothesize that PDRP will be served as a biomarker to help     us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which     might be able to provide further evidence for clinicians to address the above critical issue.   "
138580|NCT01470846|"     Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and     postoperative respiratory complications together with quicker recovery of bowel function.     Currently, no studies have been able to prove its ability to reduce length of stay in     intensive care and high-dependency units.      Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of     stay in intensive care unit after abdominal surgery under laparotomy.   "
138605|NCT01470521|"     The purpose of this study is to determine whether people with MS who are exposed to a small     number of hookworms will have less inflammation and less MS disease activity.   "
138581|NCT01470833|"     Acute achilles tendon rupture is relatively frequent (11 to 37 per 100,000). There are great     social benefits in optimizing treatment and shortening recovery.      There is no consensus concerning the best treatment of acute achilles tendon rupture.     Traditionally, surgical treatment is considered superior, but more recent studies show     evidence that non-operative treatment with early dynamic rehabilitation gives the same     functional outcome with fewer side effects.      Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not     evidence based rather due to tradition. It is well documented that mechanical load improves     tendon healing in general and has no detrimental effect on the healing of operated achilles     tendons.      The objective of this randomized study is to compare early weight-bearing with     non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.   "
138582|NCT01470820|"     Background: Using light emitting diodes (LED's) during conventional phototherapy it is     possible to reduce the distance from light source to infant, thereby increasing light     irradiance.      Objective: To examine the relation between light irradiance and the rate of decrease in total     serum bilirubin concentration (TsB) and to see if the investigators can identify a     saturation point, i.e. an irradiation level above which there is no further decrease in     TsB.      Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric     Department, Aalborg Hospital, Aarhus University Hospital, Denmark.      Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated     hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device     to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of phototherapy     and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB expressed in     percent (∆ TsB0-24 (%)).   "
138583|NCT01470807|"     A single arm, single treatment study is proposed to assess the feasibility of a portable     artificial pancreas system outside of a hospital based clinical research center.      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions     (hotel).   "
138600|NCT01470586|"     Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups     for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for     RNA peroxidation)in patients with colorectal cancer undergo surgical treatment     (preoperatively during the intervention and postoperatively) and controls.   "
138601|NCT01470573|"     Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to     corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using     cell culture technics that could permit the biological replacement of damaged ocular surface.   "
138584|NCT01470794|"     This is a multicenter study evaluating the safety and tolerability of increasing doses of     Toca 511, a retroviral replicating vector, injected into the resection cavity of subjects     with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their     tumor. Approximately 6 weeks after injection of Toca 511, subjects will take an oral course     of 5-FC, an antifungal antibiotic. These one week courses of 5-FC will be repeated during the     31 week study. In some subjects, Toca 511 and Toca FC will also be evaluated with either of     the following standard treatments for glioma: lomustine, a drug approved by the FDA to treat     brain tumors or bevacizumab, an alternative drug approved by the FDA to treat brain tumors.     After completion of this study, all subjects will be eligible for enrollment and encouraged     to be in a long-term continuation protocol that enables additional Toca FC treatment cycles     to be given, as well as permits the collection of long-term safety and survival data.   "
138585|NCT01470781|"     The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based     cognitive remediation treatment program in patients with bipolar disorder and its effects on     cognitive deficits and community functioning compared to an active, computer-based control.   "
138586|NCT01470768|"     This clinical trial will compare the amount of fatty acids in whole blood of babies fed one     of two study formulas for 4 months.   "
138587|NCT01470755|"     In older children and adults, bronchodilator (BD) dose-effect relationship is part of the     characteristics of asthma disease. There are no data on BD dose-response relationship in     wheezy preschool children whose disease pathophysiology is poorly understood, but may, in     part, takes on the characteristics of asthma.      The investigators assume that 1) in young children interrupter resistance (Rint) could be     used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the     dose-response relationship could depend on the environment and gene polymorphism ADBR2.      This is a prospective phase II study on dose-response relationship and description of the     dose-response curve design using a sparse and a modeling approach MCP-Mod.      The dose-response relationship will be modeled by sparse data. The investigators will test     two doses per child in four designs that will be drawn. These doses will be assessed using     Rint technique by a person blinded to the actual dose delivered to the child.      Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with     an accuracy of 3.5%, 8.9% and 25.7% respectively.      The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for     inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA     (No. 344 387-3)   "
138588|NCT01470742|"     The objective of the trial is to compare Overall survival between capecitabine plus     oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with     advanced gastric cancer.   "
138589|NCT01470729|"     Autosomal dominant cerebellar ataxias (ADCA) are a group of neurodegenerative disorders that     are clinically and genetically various. BIOSCA study aims to identify markers of the     metabolism (energy production inside the cells) in the blood and the brain of ADCA 1,2,3 and     7 patients and control subjects, in the perspective of future therapeutic trials.   "
138590|NCT01470716|"     This study examines preoperative Erlotinib in patients with operable stage II and IIIA     Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.   "
138591|NCT01470703|"     This international multicenter, randomized, open trial will evaluate the impact of     Extracorporeal Membrane Oxygenation (ECMO), instituted early after the diagnosis of acute     respiratory distress syndrome (ARDS) not evolving favorably after 3-6 hours under optimal     ventilatory management and maximum medical treatment, on the morbidity and mortality     associated with this disease.   "
138592|NCT01470690|"     The objective of this study is to determine the effect of multiple dose omeprazole on the     pharmacokinetics of boceprevir and vice versa.      Furthermore, the safety of steady state boceprevir combined with multiple dose omeprazole     will be evaluated.   "
138606|NCT01470508|"     Promoviendo Alimentacion Saludable (PAS)Promoting Healthy Eating is a research project     funded by the National Institute of Mental Health. The purpose of this study is to develop     and test a treatment for eating disorders in Latina adults that is appropriate for their age     and includes culturally appropriate family intervention.   "
138593|NCT01470677|"     This is a randomized trial of 140 women with endometrial or cervical cancer undergoing     removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to     the pelvic side wall after tissue removal is tested against no such intervention after tissue     removal. The primary endpoint is to evaluate the incidence of symptomatic pelvic lymphoceles     defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or     laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the     application of Tachosil® during surgery. The study's hypothesis is that the application of     tachosil fibrin patches will significantly reduce the rate of symptomatic lymph cysts.   "
138594|NCT01470664|"     This randomized, double masked, multi-center study is being conducted to support the safety     and efficacy of FST-100 for the treatment of acute adenoviral conjunctivitis.   "
138595|NCT01470651|"     Fatigue is one of the most common side effects of the treatment of hepatitis C infection with     pegylated interferon and ribavirin, and is a major cause of treatment discontinuation.     Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and     shift-work sleep disorder. This is a randomized placebo controlled study to determine whether     patients assigned to armodafinil have fewer missed doses, dose reductions or treatment     discontinuation due to side effects in the first 12 weeks of treatment for hepatitis C     infection than do placebo patients. Placebo patients are offered 14 weeks of open label     armodafinil after Week 12.   "
138596|NCT01470638|"     The study aims to correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to     markers for inflammation and degeneration in patients with primary Sjogrens syndrome.   "
138597|NCT01470625|"     This is a before-after phase II study, according to the Medical Research Council framework,     investigating the feasibility of introducing the Liverpool Care Pathway for the dying patient     (LCP) in 5 Ligurian hospices.   "
138598|NCT01470612|"     This study is an open label, long-term extension study for subjects with moderate to severe     ulcerative colitis designed to evaluate long term therapy of CP-690,550.   "
138599|NCT01470599|"     The study hypothesis is to establish the safety and tolerability of long-term open-label (OL)     CP-690,550 therapy in subjects with Crohn's disease.   "
138602|NCT01470560|"     Many women experience the accidental loss of urine called urge incontinence or overactive     bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine     which results in leakage before reaching the toilet. The current usual treatments for urge     incontinence include behavioral treatment, physical therapy, and medicines. Although these     treatments have been found to be effective in research studies, they are less effective over     time in general practice. Because medicines have side effects, many women stop them. The     purpose of this study is to explore different treatments that may provide another option for     women with urge incontinence that might be effective. This is an initial study to see if     these treatments are at least as effective as the usual treatments.      Hypothesis: Does Mind Based Stress Reduction(MBSR)(meditation practices)reduce urinary urge     incontinence episodes?   "
138603|NCT01470547|"     The portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC),     neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory     diseases, trauma and surgery. LC is an important predisposing disease and is responsible for     about 20% of all cases. However, data regarding the PVT in cirrhosis are insufficient.      Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can     occur in approximately 10% of cirrhotic patients.      Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A study     in transplant recipients, has documented that in variable etiology cirrhosis, the PVT was     present in 15.7% of patients, a higher percentage was found in patients with liver cancer     (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are less     frequently complicated by PVT.      The PVT development is due to stagnation in the portal circulation, but alterations in the     sense of inherited or acquired pro-coagulant may favor its appearance.      The causal association of PVT with bleeding and bowel infarction suggests that the PVT may     reduce survival in cirrhosis, but data are lacking on this issue. It is also not known     whether asymptomatic patients with PVT have a different survival compared to cirrhotic     patients without PVT. Further studies should be conducted to clarify this issue.      Likewise, prospective studies are needed to better identify risk factors predisposing to PVT     in LC patients as well as to clarify the relationship between cirrhosis severity and PVT. The     impact of PVT on the natural history of cirrhosis is an issue today still debated.      The PVT not only favour life-threatening complications (gastrointestinal bleeding and     mesenteric thrombosis) but could also contribute to a deterioration of liver function by     reducing portal flow. Obtaining such information would be of crucial importance considering     that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the     need for randomized controlled trials to clarify the potential effectiveness of anticoagulant     therapy to improve the survival.      To this purpose it's proposed to establish an Italian register of patients with cirrhosis. In     the second phase of the project is planned a 2-years follow-up program in order to assess     whether the PVT be an additional risk factor for mortality or deterioration of the natural     history in patients with cirrhosis.   "
138604|NCT01470534|"     Having an operation places an enormous burden on the body, leading to the development of     inflammation and so called 'insulin resistance'. Insulin resistance means the body is unable     to respond to important hormones that control use of energy. Recent studies have shown that     patients who develop 'higher' insulin resistance and inflammation have more serious     complications and take longer to recover after surgery. The investigators do not know what     controls the development of insulin resistance and inflammation after surgery. Similarly, the     investigators do not know why certain patients develop much more insulin resistance and     inflammation than others, even though they have the same operation.      The main purpose of the study is to try to find out which patients are prone to developing     greater 'amounts' of insulin resistance and inflammation. The investigators also want to find     out whether the investigators can reduce the 'amount' of insulin resistance and inflammation     in these patients (for example by giving them carbohydrate [sugar-based] drinks before     surgery - these have been shown to reduce insulin resistance in some patient groups).      Information from this study should improve the way the investigators prepare patients before     surgery and this should help to improve patient outcomes following surgery (by reducing     complications and speeding recovery after major surgery).   "
138607|NCT01470495|"     RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a     promising drug to treat late stage HCC. But few studies were related with its effectiveness     on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might     reduce the frequency of recurrence and improve the overall survival and disease free survial.   "
138608|NCT01470482|"     Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby     improve fixation, it might also cause complications. Migration as measured by     RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use     of a tourniquet influences fixation measured with RSA.   "
138609|NCT01470469|"     This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years     with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and     ECGs.   "
138610|NCT01470456|"     Primary Objective:      Participants Achieving an Objective Response Rate (Cheson 2007)      Secondary Objectives:        -  Progression Free Survival        -  Overall Survival        -  Response Duration   "
138611|NCT01470443|"     The objective of the trial is to compare Progression free survival between GEMOX     (gemcitabine/oxaliplatin)vs XELOX(capecitabine/oxaliplatin)in metastatic or unresectable     Biliary tract carcinoma patients.   "
138612|NCT01470430|"     The purpose of this study is to measure systemic levels of vascular endothelial growth factor     (VEGF) and other proteins (e.g. IGF-1) in the systemic circulation of infants with     retinopathy of prematurity (ROP) following ocular treatment with either intravitreal     injections of anti-VEGF agents or retinal laser photocoagulation. The primary aim is to     determine if serum VEGF levels change after treatment.   "
138613|NCT01470417|"     This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable     and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.   "
138614|NCT01470404|"     To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity     profile.      To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor     suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric     cancer patients treated with adjuvant chemotherapy.   "
138615|NCT01470391|"     The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus     the Femoral Nerve Block on muscle strength, pain and mobilization after total knee     arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and     morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps     muscle strength.   "
138616|NCT01470378|"     This study will investigate the subcutaneous tissue changes in the lymphedema found after     thigh surgery, by circumferential measure of thr thighs and by magnetic resonance imaging     verifying the effects of postoperative lymphatic drainage.   "
138618|NCT01470352|"     To delineate brain mechanisms that subserve EA in the healthy state and to identify     alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance.     Individuals with migraine will be examined between episodes in order to assess basal     alterations in the efficiency of spatial and temporal filtering of noxious information. This     population provides the unique opportunity to examine such processes without confounds     arising from ongoing pain.   "
138619|NCT01470339|"     -  To delineate brain mechanisms that subserve endogenous analgesic (EA) in the healthy          state.        -  To identify alterations in mechanisms supporting EA in chronic pain (migraine) and their          therapeutic relevance.   "
138620|NCT01470326|"     In this survey, to collect the safety and efficacy information of Bazedoxifene in daily     medical practice will be examined. In addition, the necessity of special Investigation and     post-marketing clinical studies will be examined, while investigating unexpected adverse drug     reactions during the survey period and understanding of the status of frequency of adverse     drug reactions in daily medical practice.   "
138621|NCT01470313|"     This study is designed to evaluate the safety and tolerability of multiple intravenously     administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in     disease activity will also be evaluated.   "
138622|NCT01470300|"     The purpose of this research is to investigate how using different methods to reduce the     energy density of entrees affects daily energy intake in adults. It is hypothesized that     reducing the energy density of entrees will decrease energy intake. It is also hypothesized     that reducing the energy density by incorporating fruit and vegetables will decrease energy     intake more than reducing the energy density by decreasing fat content or adding plain water.   "
138623|NCT01470287|"     This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent     vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.   "
138624|NCT01470274|"     The primary objective is to establish the safety of the CO-rebreathing method for measuring     total blood and plasma volume in CAD patients. The working hypothesis is that the     CO-rebreathing method is safe in use with coronary artery disease patients and that it does     not cause myocardial ischemia or cardiovascular damage.   "
138625|NCT01470261|"     The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate (trade     name ritalin) on growth, neurological system, psychiatric states and cardiovascular system     over a two year period in children and adults.   "
138635|NCT01470131|"     The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in     combination with bortezomib and dexamethasone to placebo in combination with bortezomib and     dexamethasone in the treatment of patients with relapsing multiple myeloma who have received     one previous therapy.   "
138636|NCT01470118|"     This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to     artificial tears (placebo) in the prevention of ocular itching associated with allergic     conjunctivitis.   "
138722|NCT01468974|"     The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance     of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease     of the superficial femoral (SFA) or common or external iliac arteries.   "
138626|NCT01470248|"     The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in     patients with small cell lung cancer who have failed at least one standard chemotherapy     regimen as well as patients who are unable to tolerate the standard treatment for their     cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide in     this patient group. The study will include up to 36 participants with small cell lung cancer.      The investigators want to find out what effects, good or bad, that the study drug has on your     cancer. This study will also look at specific biomarkers in your blood and in the tumor     tissue which may help the investigators to determine if the levels of these biomarkers are     related to tumor response to treatment.      Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by     the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer     called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more     mature thereby stopping them from growing in number and more likely to die off.   "
138627|NCT01470235|"     The purpose of this project is to examine whether the risk of developing ovarian cancer is     increased in Danish women with congenital missing teeth as a result of their failure to     develop (hypodontia). Should this prove to be the case, these women could be offered regular     clinical controls and prophylactic removal of their ovaries when menopause enters and the     ovaries are no longer functional (producing hormones).      If there is a connection between congenital hypodontia and the development of different types     of cancer, the investigators will perform a genetic screening in families with increased risk     of cancer and hypodontia for changes in relevant genes, based on the current literature. The     investigators hereby search for new genes, which in a changed form leads to an increased risk     of cancer and thereby enables us to perform genetic screening in risk families.   "
138628|NCT01470222|"     This study is a randomized controlled pilot of a work site weight control intervention. The     purpose of the pilot is to obtain preliminary data for future NIH submissions. Four work     sites were identified through a multistage recruiting process. Work sites were randomized to     either the intervention group, which will receive the intervention immediately following     randomization or the control group which will receive a shortened intervention over a 1-month     period, 6 months after the active intervention sites have completed their program. The     intervention will consist of a variety of activities conducted over a 6 month period, that     are overseen by a work site-Tufts oversight group, including the following optional elements:     For overweight and obese individuals, regular support groups for weight loss and prevention     of weight regain. For all work site employees irrespective of weight, handouts and posted     informational resources on healthy eating, monthly lunchtime seminars, and food sampling to     facilitate healthy eating patterns for prevention of weight gain.      Basic online assessments on health and nutrition will be carried out at baseline (week 0) and     24 weeks in all work site employees willing to provide information. More detailed online and     in-person assessments will be performed throughout the 24-week study period in the weight     loss support group participants (intervention sites) and individuals intending to enroll in     the support group (control sites).   "
138630|NCT01470196|"     Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within     the cell, which is responsible for degrading or breaking down a wide variety of proteins.     Carfilzomib has not been approved by the FDA.      Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM),     alone or in combination with other drugs. Combinations with rituximab, dexamethasone and     proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients.      In this research study, the investigators are testing the safety and efficacy of Carfilzomib     when used along with Rituximab and Dexamethasone as a possible treatment for Waldenstrom's     Macroglobulinemia.   "
138631|NCT01470183|"     This is an exploratory study. No formal hypothesis will be tested.      The objectives of this study are to follow Lupus Nephritis patients over a period of 12     months to:        -  Establish the baseline biomarker characteristics of patients        -  Determine the variability of biomarker measures over time        -  Correlate biomarkers with disease phenotype   "
138632|NCT01470170|"     Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many     other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic     onset and quick recovery, synergic sedative effect and unwanted side effects too. However,     the amount of Alf needed in combination with Pro for induction and the timing of     administration was no standardized. The investigators designed this study to evaluate the     optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for     flexible bronchoscopy sedation, and also to evaluate the influence of variable regimen of Alf     and Pro on hypoxemia, hypotension, cough severity, and Pro injection related pain.   "
138633|NCT01470157|"     Background: Sedation is often needed for young children undergoing minor procedures in the     emergency department (ED). Oral midazolam is one of the most commonly used regimens for     children undergoing laceration repair but its sedative efficacy was shown to be suboptimal.     In a few studies oral ketamine has been used successfully for procedural sedation as well.     The efficacy of using a combination of oral midazolam and oral ketamine for procedural     sedation has been studied only for invasive procedures in children with malignancies. No     randomized controedll studies were performed using this sedative combination in children     requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine to     oral midazolam for procedural sedation in children requiring laceration repair compares to     oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled study.     Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with laceration     requiring sedation. Interventions: Eligible patients will be randomly assigned to one of two     treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral     ketamine group. Both groups will be given the same volume of medications. Midazolam will be     given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with     oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the treatment given.     Patient monitoring will be conducted according to the American Academy of Pediatrics (APP)     and the Israeli health ministry guidelines for monitoring and management of pediatric     patients during and after sedation for diagnostic and therapeutic procedures. Main outcome     measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis: Descriptive     statistics will be used to describe the study population. Data will be analyzed using t-     tests for continuous data and Fisher exact test for categorical data.      Key words: sedation, children, ketamine, midazolam, emergency department.   "
138634|NCT01470144|"     This is an open-label, nonrandomized extension to study AC-066A301. The study will assess     safety and tolerability of ACT-385781A while providing a means for continuing treatment after     ending participation in study AC-066A301.   "
138637|NCT01470105|"     The goal of this study is to improve how we estimate survival of people with cancer that has     spread to their bone. There have been previous attempts to estimate survival of people with     cancer that spread to the bone, but they have not been accurate. This study will try to     improve the way we estimate survival in people with cancer that has spread to their bone by     looking to see if a physician assessment and a patient assessment of the health status can be     blended to give a better estimate of survival than patients or doctors alone.   "
138638|NCT01470092|"     Longitudinal epidemiological studies have shown that many women experience significant     physical and psychological changes as they approach menopause and for a long time following.     Vasomotor symptoms (such as hot flushes, night sweats), sleep disturbances and changes in     libido are common, and impact significantly on the quality of life, social and personal     well-being. However, the major reason that many women seek help from menopause clinics or     their doctors, is for depression and anxiety symptoms. As such, treatment commonly draws on     traditional approaches for the management of major depression including the use of     antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or Selective     Norepinephrine Reuptake Inhibitors (SNRIs) as the first line response. However, standard     treatment of menopausal depression using antidepressants has only shown small improvements at     best and at worst, is associated with severe side effects. Some SSRIs have been shown to be     less effective in postmenopausal women compared to child bearing age women.      Newer therapies directly targeting the disrupted hormonal systems (in particular estrogen)     through the administration of such compounds as tibolone, have shown significant potential to     treat depression with the added benefit of fewer adverse side effects. With growing evidence     supporting the use of tibolone as a viable and improved treatment for menopausal depression,     the investigators propose to investigate the potential of tibolone, a selective Hormone     Replacement Therapy (HRT), to ameliorate de-novo or first onset depression occurring in the     menopausal period.   "
138639|NCT01470066|"     Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography     (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in     predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma     (DLBCL), the positive predictive value (PPV) of interim PET/CT scanning has not been     determined in patients with peripheral T cell lymphoma (PTCL). The sequential interim PET/CT     will be prospectively investigated to determine whether it provided additional prognostic     information and could be a positive predictable value for the treatment of PTCL.   "
138640|NCT01470053|"     The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus     azelastine HCl in patients with perennial allergic rhinitis.   "
138648|NCT01469949|"     Mental imagery has been used in a variety of pathological instances in support to classical     therapeutic treatments. The aim of the present study was to observe the effect of internal     Kinesthetic and external Visual Imagery to improve proprioceptive feedback in low back pain.     Fifty-five subjects with a history of low back pain were included in two experimental groups     who used mental imagery and one control group who did not. The results showed the     effectiveness of the Internal Kinesthetic Imagery to improve the accuracy of repositioning of     lumbo-sacral spine that may subsequently improve the quality of the proprioceptive input. The     possibility to use effectively mental imagery, as a part of proprioceptive rehabilitation     process, is the principal outcome of this study.   "
138641|NCT01470040|"     Anti-aggregation therapy, including treatment with low-dose aspirin (LDA) is an established     risk factor for intracranial hemorrhage, including chronic subdural hematoma (CSDH); however     evidence guiding the decision to continue or discontinue LDA in patients who have sustained     mild head trauma with no sign of injury on CT is lacking. The investigators aim to assess     whether continued aspirin treatment increases the risk of CSDH in mild head trauma patients     50 years and older who present with negative head CT. The investigators further aim to use     the initial findings to refine the study design, with the goal of performing a larger,     multi-institutional study in the future.      Over a 12-month period, approximately 100 patients ≥50 years of age on LDA prophylaxis     presenting to Hadassah's Emergency Department after sustaining mild head injury, will be     examined by the neurosurgeon on call. Those who have no sign of intracranial hemorrhage at     clinical or CT examination, and who meet inclusion / exclusion criteria, will be invited to     participate in a randomized study. Informed consent will be obtained. Patients will be     remotely randomized for continuation or cessation of LDA treatment. Follow-up CT and clinical     examination will be performed 3-5 weeks after trauma.      The two-proportions test will be used to assess whether there is a statistically significant     difference in the rate of CSDH in patients randomized to cessation of LDA therapy and those     randomized to continuation of LDA. Relationships between the explanatory the dependent     variables will be explored with classical parametric and nonparametric statistical methods,     including multivariate analysis, logistic regression, the two proportions test, and the     independence test. Several measures of association/correlation between pairs of variables     will be analyzed as well.      The investigators hypothesize that continuation of LDA will not be associated with increased     risk for chronic subdural hematoma, and that cessation of treatment will not be associated     with a decrease in chronic subdural hematoma. The investigators further hypothesize that     cessation of LDA for this period will not be associated with increased risk for clinically     significant cerebrovascular, cardiovascular, thrombotic, of embolic event.   "
138642|NCT01470027|"     The overall objective of this developmental/exploratory study is to use noninvasive proton     magnetic resonance spectroscopy (1H MRS) to determine (a) whether levels of the antioxidant     glutathione (GSH) are decreased in vivo, as has been found in postmortem brain, in the brain     of 30 patients with Parkinson's disease (PD) compared to matched controls; (b) whether GSH     levels in PD brain increase significantly following 30 days of daily supplementation with     1800mg or 3600mg of N-acetylcysteine (NAC) compared to placebo and to baseline, and (c)     whether any such increases in brain GSH would be dose-dependent and be associated with a     change in the participants' oxidative stress profiles. In addition, a clinical assessment     battery, including quantitative tests of motor function, will be performed to investigate     potential associations between the NAC intervention, brain GSH levels, oxidative stress     markers, and clinical presentation. If successful, this study will represent the first     objective documentation of whether there is a GSH deficit in living PD brain that dietary NAC     supplementation can mitigate, thereby providing a compelling justification for investigating     such neuroprotective strategies in larger controlled clinical trials.   "
138643|NCT01470014|"     The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC)     have been well established for echocardiography and cardiac magnetic resonance, such     validation is lacking for computed tomography (CT). Such criteria are of great clinical     relevance as a growing number of patients undergo a cardiac CT scan in daily clinical     routine.      The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC     from lesser degrees of trabecular layering seen in potential differential diagnoses such as     cardiomyopathies and left ventricular hypertrophy or dilation.      The investigators hypothesize that echocardiographic diagnosed pathological trabeculation can     be distinguished by determining the ratio of non-compacted to compacted myocardium on cardiac     CT.   "
138644|NCT01470001|"     This is a double-blind, randomized, controlled, parallel design (n=140) study with the     purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void     Dribbling.   "
138645|NCT01469988|"     Evaluate the efficacy and safety of testosterone supplementation on functional capacity,     biomarkers, quality of life and clinical outcomes for patients with heart failure.   "
138743|NCT01468688|"     The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2     dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.   "
138646|NCT01469975|"     Advanced synovial sarcoma represents an unmet medical need. The gene encoding frizzled     homologue 10 (FZD10), a 7-transmenbrane receptor, member of the Wnt signalling receptor     family, is overexpressed in SS and is undetectable in normal human tissues except placenta.      OncoTherapy Science Inc. has developed a chimeric humanized monoclonal antibody (mAb) against     FZD10, named OTSA101. Non-radiolabeled OTSA101 antibody has only weak antagonistic activity     on SS cell growth. However, Yttrium 90-radiolabeled OTSA101 (OTSA101-DTPA-90Y) showed     significant antitumor activity following a single intravenous injection in mouse xenograft     model.      This first in man clinical trial (Phase I) in relapsing SS patients resistant to Doxorubicin     and ifosfamide will be divided in 2 parts.      In Part 1 (imaging part using OTSA101 radiolabelled with Indium 111 [111In]), the     biodistribution and tumor uptake of OTSA101-DTPA-111In will be followed using 111In as     radiotracer.      In Part 2 (therapeutic part with OTSA101 radiolabelled with Yttrium 90 [90Y]), the safety and     PK profiles of OTSA101-DTPA-90Y will be determined and preliminary efficacy data will be     collected.      This first in Man study should allow defining the optimal recommended dose of     OTSA101-DTPA-90Y.      Patients will be followed during 1 year.   "
138647|NCT01469962|"     Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France     (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic     steatohepatitis (NASH) both complicate morbid obesity and could be responsible for the     development of liver fibrosis and consequently of liver cirrhosis. Bariatric surgery has been     widely used in obese patients to reduce their weight but also to decrease morbidity     conditions related to obesity. It could be involved in an improvement in liver lesions     observed in obese patients. To evaluate the severity of liver lesions, the gold standard is     pathological examination of the liver using percutaneous or surgical biopsies, with a scoring     called Fibrosis score stage. Alternative less invasive techniques have been developed to     evaluate liver lesions. These tests are commonly used in clinical hepatology and consisted of     serum levels determination of fibrosis markers (Fibrotest, Transthyretin).      The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in a     population of patients operated on for morbid obesity ( BMI > 40kg/m2 or BMI> 35kg/m2 with     comorbidity). The primary end point is to evaluate the concordance between Fibrotest and     transthyretin serum levels. The number of patients has been calculated on the basis of a     concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that     represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in     this study. According to the number of patients operated on in the 3 centres (>150/year), the     time for recruitment is 12 months. Secondary end points will evaluate in these patients the     excess weight loss, the improvement in fibrosis liver tests and the correlation with     improvement in other obesity- related conditions, according to surgical procedures.   "
138660|NCT01469793|"     This multicenter, open-label, dose-escalating study will assess the safety, tolerability, and     pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or     platinum-resistant ovarian cancer. Cohorts of participants will receive multiple ascending     intravenous doses of DMOT4039A.   "
138661|NCT01469780|"     The focus of this secondary data analysis is to determine whether pain due to a combination     of both cardiac and non cardiac sources operates as a mediator of behavior change, an area     that has not been previously evaluated.   "
138649|NCT01469936|"     Fibromyalgia is a medical disorder characterized by chronic widespread pain, and a heightened     and painful response to pressure. Fibromyalgia symptoms are not restricted to pain, leading     to the use of the alternative term fibromyalgia syndrome for the condition. Other symptoms     include functional gastrointestinal pain and discomfort.      The origin of these symptoms is not yet known, and a few hypotheses have been stated. One of     the supposed mechanisms that may lead to gastrointestinal hypersensitivity is a chronic,     low-grade, intestinal inflammation due to an increased intestinal permeability.      In this study, we hypothesise that the food supplement PERMEAPROTECT (that contains, amongst     other nutrients, glutamine and curcumin) contributes to reducing the intestinal permeability     and low-grade inflammation, thus improving gastrointestinal quality of life.   "
138650|NCT01469923|"     This is a randomised and single-blind, placebo-controlled study to investigate the safety,     tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820     to obese but otherwise healthy male subjects.   "
138651|NCT01469910|"     The purpose of this study is to assess the safety and pharmacokinetics of single ascending     doses of Simotinib Hydrochloride in healthy subjects.   "
138652|NCT01469897|"     This project seeks to collect data on healthcare utilization and expenditure rates in     Juvenile Idiopathic Arthritis (JIA) patients from across the US, correlate these costs with     disease activity and outcome measures and determine methods by which to reduce the economic     impact while improving outcomes.   "
138653|NCT01469884|"     Compare the viral load of hepatitis c virus in patients converted to certican versus patients     who are maintained on calcineurin inhibitor.   "
138654|NCT01469871|"     The purpose of this study is to determine if one of the new types of dressings (MEPORE PRO     and/or MEPILEX BORDER ) will reduce the blister rate compared to the currently used HYPAFIX.   "
138655|NCT01469858|"     The main objective of the study is to explore and map brain areas involved in sensory     perception and multisensory integration in patients with central or peripheral neurological     damage. The investigators hypothesize for example, that a change (compare to healthy     subjects) in the perceptual maps and body representation could be detected and characterize     in patients suffering from impairments of peripheral nerve conduction.   "
138682|NCT01469507|"     The primary objective of this study is to compare a combination of hyaluronic acid and     chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee     osteoarthritis (OA) over 24 weeks when administered in three weekly injections.      Chondroitin sulfate is one of the components of cartilage. Studies have shown that     chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The     benefit of V0220 combination is based on two main physicochemical properties, in line with     the characteristics of osteoarthritic disease: optimising the rheological behaviour and     improving the buffering effect on synovial flow (outflow buffering).   "
138683|NCT01469494|"     The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast     reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an     improvement as it does not damage the abdominal wall. The SIEA unfortunately has smaller     vessels which put the flap at a higher risk of developing flap loss and fat necrosis. The     uncertainty regarding the tradeoffs inherent in the choice of procedure has not been     resolved. As such the investigators aim to perform a randomized single blinded trial to     evaluate the abdominal and breast related morbidity associated with DIEP and SIEA flaps.   "
138656|NCT01469845|"     Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the     lungs, and then the airways become blocked, leading to difficulties with breathing. It is the     most common reason why children are admitted to hospital, with 1-3% of all children admitted     to hospital during their first winter, creating enormous strains on NHS services. The     majority of those admitted with the condition are under six months of age and the associated     stress for parents is considerable. After forty years of research the best treatment we have     is supportive care and oxygen.      Recent research suggests that salt water, sprayed as a mist so that the children can breathe     it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis.     Scientists think that the salt water changes the mucus which blocks the airways so that it     can be cleared more easily. Three small research studies all suggested that a child's time in     hospital could be reduced by a quarter by using this treatment. If this was true, it would be     good for children, their families and the children's wards trying to cope with the large     numbers admitted with bronchiolitis every year.      To decide whether this treatment should be used throughout the NHS, we need to run a     randomised controlled trial of hypertonic saline in a large number of children. The trial     will tell us if adding saline to usual care reduces distress in both children and parents, as     well as whether it reduces the length of time they stay in hospital. We will then know if the     treatment is the best thing for children with bronchiolitis and whether it provides the NHS     with good value for money.   "
138657|NCT01469832|"     The purpose of this study is:      To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD .      To evaluate potential efficacy endpoints to be used in future studies RPE cellular therapy.   "
138658|NCT01469819|"     The purpose of this study is to determine if lubiprostone may change the rate of movement of     food and activities in the stomach and intestines in subjects whose gastrointestinal (GI)     tract is slower due to constipation.      To be able to measure the time difference in the duration of transit of the FDA approved     SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to     lubiprostone.      The investigators anticipate to capture the possibility to reduce/eliminate the small     intestinal bacterial overgrowth in chronically constipated patients after administration of     study drug- lubiprostone.   "
138659|NCT01469806|"     The primary objective of the Registry is to allow for tracking of FDA approved and/or cleared     knees used in primary, revision, unicompartmental or partial total knee arthroplasty (TKA).     Second, it is our desire to assist orthopaedic surgeons in obtaining and evaluating     radiographic and functional outcomes data on their PFJ patients using current published     guidelines. Third, within this Registry, subsets of data on newer technology are being     collected for the purpose of future publications. The Patello-Femoral Joint Post Market     Clinical (PFJ PMCF) study is one such subset.   "
138662|NCT01469767|"     The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide     cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).   "
138663|NCT01469754|"     Posttraumatic Stress Disorder (PTSD) is a well-documented phenomenon that occurs in cancer     survivors. PTSD is known to cause problems with anxiety, depression, and quality of life.     Furthermore, there is little treatment available for cancer survivors who suffer from PTSD.      Posttraumatic Growth, however, is a lesser known phenomenon that also occurs in cancer     survivors. It is a positive psychological phenomenon that occurs in some people who have     suffered a traumatic event--the people who are able to note a greater appreciation for     life, a stronger relationship with their family/friends, or a new found level of     spirituality are examples of instances of posttraumatic growth.      Coping with Lymphoma to Enhance Adjustment and Reduce Stress in Survivors (CLEAR Stress) is a     study designed to compare the development of PTSD versus the development of Posttraumatic     Growth in lymphoma patients at any stage of the cancer experience, regardless of treatment.     The hypothesis is that posttraumatic growth, if it is significant, can reduce the impact of     PTSD symptoms in the survivor.   "
138664|NCT01469741|"     Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and     is a significant source of disability and reduced quality of life. Unfortunately, there are     no successful interventions to address these impairments. Prospective memory impairment is a     particularly functionally- and clinically-relevant problem in PD. The investigator's project     will determine if a targeted intervention strategy improves PD participants' prospective     memory. The investigator's goal is to improve PD patients' everyday prospective memory so     they can successfully perform desired activities and roles.   "
138665|NCT01469728|"     Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients     with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence.      General anesthesia and one lung ventilation is the standard type of anesthesia employed for     VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating     patients is being increasingly employed to perform several cardio-thoracic surgery procedures     in an attempt of minimize operative risks and facilitate resumption of daily-life activity.      The investigators have reasoned that for a simple and palliative procedure such as talc     pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might     be considered a potential cause of morbidity and delayed recovery. The investigators have     also hypothesized TEA could be considered an optimal type of anesthesia in this setting     leading to a fast recovery a reduced overall workload in medical care.      In this single-center randomized study, the investigators have comparatively assessed the     impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive     results of VATS talc pleurodesis.   "
138684|NCT01469481|"     The purpose of this study is to evaluate the excretion balance, metabolic profile and the     routes of excretion of [14C]PF-04991532 in healthy adult male subjects.   "
138685|NCT01469468|"     The study is designed to investigate the effect of repeated dosing of PF-05175157 on the     pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.   "
138666|NCT01469715|"     The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies     Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1     diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL)     glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels     when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing     41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous     insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal     is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and     displays blood sugar (glucose) levels in the body throughout the day and night. The method     being used to detect blood sugar in the investigational Glucose Binding Protein-Based     Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by     commercially available models.      Some sensors cannot tell the difference between glucose (sugar) and other substances such as     Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give     false readings. The GBP CGM is made to only recognize glucose in the body rather than other     substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect     the new GBP CGM to be more accurate at detecting low blood sugar levels than the current     devices.   "
138667|NCT01469702|"     Bartonella henselae is the etiologic agent of cat scratch disease (CSD). 90% of patients     present with regional lymphadenitis (typical CSD) while 10% will have disease involving other     organs, such as neuroretinitis, arthropathy, erythema nodosum, and encephalitis (atypical     CSD). In most CSD cases resolution occurs in 2 to 3 months although a prolonged course often     occurs. Data on the efficacy of antibiotic therapy in CSD is limited. Azithromycin has been     shown to have a small favorable effect in a small comparative study and is commonly     prescribed for CSD, however its overall effect is not satisfactory. Corticosteroids may be     effective in the treatment of CSD for the following reasons:        -  Many experts believe that host response is involved in the pathogenesis of CSD and is          responsible for the clinical manifestations rather than the direct effect of B.          henselae. The absence of viable organisms in affected lymph nodes (in the presence of          positive PCR for B. henselae DNA), and the fact that arthritis, arthralgia and erythema          nodosum (that are often associated with autoimmune diseases) have been described in CSD,          support this concept.        -  Corticosteroids have been anecdotally reported to have been administered to patients          with CSD, apparently with some success. The purpose of this study is to evaluate the          efficacy of corticosteroids in addition to azithromycin in CSD. The study hypothesis is          that corticosteroids will improve out come. Ten patients with typical CSD will be          treated with a 5-day oral course of prednisone (1 mg/kg up to 60 mg/day) and          azithromycin (500 mg on day 1 and 250 mg on days 2-5). Patients will be under followed          up for 3 months. Major outcome measures will include duration of symptoms and signs,          with particular emphasis on affected lymph node size and duration using a specific          scoring system (lymphadenitis score, LS). LS will be used to evaluate lymphadenitis at          each follow-up visit. The time period from baseline LS until 75% and 90% reduction in LS          in the treatment group will be compared with historical controls. The historical control          group will be consisted of age, sex, and clinical manifestations-matched CSD patients          who were treated with azithromycin without corticosteroids.   "
138688|NCT01469429|"     This randomized phase I/II trial studies the side effects and best way to give lyophilized     black raspberries in preventing oral cancer in high-risk patients previously diagnosed with     stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to     keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer.     Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from     patients receiving lyophilized black raspberries may help doctors learn more about changes     that occur in DNA and the effect of lyophilized back raspberries on biomarkers.   "
138689|NCT01469416|"     The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of     rosuvastatin clinically.   "
138668|NCT01469689|"     Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but     analysis of the geographic distribution of one webCBT site showed 15-fold variation in use     across Britain. Such variation is unlikely to be from differences in prevalence. Raising     awareness of webCBT could benefit many people with depression but it is not clear how     direct-to-patient promotion online or via the media, compares with GP centred methods. This     pilot cluster randomised controlled trial will explore the use of online methods to raise     awareness in preparation for subsequent study comparing different approaches.      In a pilot cluster randomised trial the investigators will explore the feasibility and likely     impact of online methods of raising awareness of webCBT, assessing how many people with     depression respond to geographically restricted Google and local website advertisements. The     investigators will explore costs of recruitment and define and document the best online     methods that might subsequently be used in a definitive trial comparing online with mass     media and GP centred methods for raising awareness. The investigators will compare     intervention with control areas to estimate impact on registration levels and compare rate of     completion of webCBT of these 'additional' registrants with other registrants.     Recommendations will be made for a subsequent trial comparing online with other methods.   "
138669|NCT01469676|"     To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might     reduce the inflammatory response and protect the lungs against the acute injury   "
138670|NCT01469663|"     This study examines whether depression in people with borderline personality disorder is     different than depression in people without borderline personality disorder.      Unlike people who have depression alone (i.e. without borderline personality disorder),     people with borderline personality disorder have depressions that often do not improve with     medications. This makes treating depression much more challenging in someone with borderline     personality disorder than without borderline personality disorder.      Borderline personality disorderis associated with difficulty in understanding and     communicating feelings. Impaired emotion processing may reflect dysfunction of an area of the     brain, the anterior cingulate.      Depression is associated with changes in anterior cingulate activity. The investigators     believe that when borderline personality disorder is present with depression, brain activity     changes in the anterior cingulate will not be the same as in depressed patients without     borderline personality disorder.      An electroencephalogram records brain electrical activity. In this study, the investigators     will measure electroencephalogram indices reflecting anterior cingulate activity.      HYPOTHESIS: In this study, the investigators predict that when borderline personality is     present with depression, electroencephalogram indices of anterior cingulate activity will be     different from when depression is present alone (without borderline personality). This could     help to explain why people with borderline personality have depressions that are harder to     treat than depressions in people without borderline personality.      The investigators also predict that electroencephalogram indices of the anterior cingulate     will reflect emotional processing ability, as measured by validated questionnaires.   "
138671|NCT01469650|"     The specific aims of this study are to determine levels of vitamin D supplementation to     achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to     achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the     Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled     trial, infants 23 weeks gestational age or greater will be randomized to two different levels     of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an     exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these     infants.   "
138672|NCT01469637|"     This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole     administered alone & in combination with MMX Mesalazine/mesalamine.   "
138673|NCT01469624|"     Contrast induced nephropathy (CIN) is of great concern when using contrast media in the new     era of medicine. CIN is defined as 25-50% relative increase, 0.5-1 absolute increase in serum     creatinin value or 25% fall in GFR. The incidence of CIN is found to be 0% to 10% in general     population and up to 50% in high risk population. High risk patients include those with     chronic kidney disease (GFR<60 ml/min/1.73 m²) Diabetes Mellitus, congestive heart failure,     anemia and advanced age. Amount and kind of contrast medium and decreased circulating blood     volume are other important predictors of CIN. 50% of cases of CIN happen within 24 hours of     contrast injection. Maximum creatinin levels are reached between 48-72 hours. It usually     returns to previous levels in 7-10 days. Suggested mechanisms are renal vasoconstriction and     tubular injury. N-acetylcysteine and hydration are proved to be protective against CIN and     theophylline may have a role. In this study, it is hypothesized that pentoxifylline, a     dimethylxanthine, can also protect renal cells from CIN. It has been observed that     pentoxifylline improves oxygen delivery to ischemic tissues, diminishes oxidative damage to     renal tissue and may also scavenge free radicals. Percutaneous coronary intervention is     assumed a high risk procedure for developing CIN as the amount of contrast used in PCI is     remarkable. Therefore, the patients undergoing PCI were selected for the trial. A prospective     randomized trial will be conducted on patients undergoing PCI.   "
138674|NCT01469611|"     The purpose of this study is to:        -  determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of          JX-594 administered by biweekly intravenous (IV) infusion.        -  determine the safety of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by          biweekly IV infusion.   "
138675|NCT01469598|"     Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of DNA     synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits     microtubule depolymerization.      In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100     mg/m2 on day 8 with G-CSF support every 3 week.   "
138676|NCT01469585|"     The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose     doxycycline on the irregular bleeding women experience when taking continuous oral     contraceptive pills. This research is being done because currently, there is no effective     treatment for this condition. Findings from this study could help to decrease the side     effects of birth control pills and decrease unplanned pregnancies.   "
138710|NCT01469130|"     In this study, MEK162 will be administered to Japanese patients with advanced solid tumors     whose disease has progressed despite standard therapy or for whom no standard therapy exists.     The trial will investigate the safety and tolerability and determine the MTD of MEK162 in     Japanese patients.   "
138677|NCT01469572|"     The purpose of this study is to see the safety and activity of using pasireotide, everolimus     and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of     neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or     radioembolization are considered standard of care regimens in patients with liver lesions     from neuroendocrine tumors. However, the use of the combination of everolimus and     radioembolization has not been formally evaluated in the setting of a clinical trial.     Pasireotide is a medication that is intended to block the hormonal secretions from the     neuroendocrine tumors.      This study is divided into two parts. In the first part, the aim of the study is to determine     the safety of combining everolimus, pasireotide, and radioembolization. For this part of the     study the investigators will enroll up to 18 patients. After the investigators confirm the     safety of the combination, they will conduct the second part of the study which will focus on     evaluating the effectiveness of the combination. For this part of the study the investigators     intend to enroll a total of 37 patients.   "
138678|NCT01469559|"     The aim of this study is to evaluate the safety and tolerability of intranasal insulin in     people with type 1 diabetes and diabetic peripheral neuropathy and to determine whether     intranasal insulin is effective in slowing the progression of diabetic neuropathy.   "
138679|NCT01469546|"     The purpose of this study is to investigate a new agent Axitinib in the treatment of head and     neck cancer.      This is a new drug that is given as a pill twice a day to treat cancer. This is one of the     new, smart drugs. It binds to a protein on the surface of the cancer cell called VEGFR, and     this way it slows down the growth of cancer cells and kills them. Head and neck cancer cells     are known to carry this protein on their surface. Research in animals and in patients with     other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or     stopping their growth, by this mechanism. It is generally a safe drug that is given by mouth.     The investigators do not know, however, whether Axitinib is effective in head and neck     cancer. This research study is being conducted to learn if Axitinib works in head and neck     cancer, and also to learn to predict who would benefit from it. Four blood draws will be done     to check special blood tests while the subjects are treated with Axitinib. These will be     drawn at the same time as your routine labs, and there will not be additional sticks needed.     A biopsy of the tumor before and after 1 month of treatment may be obtained to test how the     cancer cells are responding to treatment. By testing these blood and tissue samples, the     researchers will look at special tests (protein molecules) to try to determine what kind of     head and neck patients would best respond to this drug. This is an open-label study, meaning     that all subjects are on the active drug and there is no placebo (sugar pill).   "
138680|NCT01469533|"     The purpose of this study is to investigate if the application of spinal mechanical     manipulation on low back region resulted in changes in pressure pain thresholds (PPT) in     asymptomatic subjects and the extent of the hypoalgesia; whether it is local, regional or     systemic. Simultaneously, the investigators are to further explore the phenomenon of reduced     sEMG activity after spinal mechanical manipulation to better understand the immediate effects     of mechanical manipulation on low back region.   "
138681|NCT01469520|"     The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric     formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in     comparison to an innovator product. Establishing the bioequivalence of a newly developed     age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral     dispersible tablet or a reconstitutable suspension for children is invaluable for future     product registration and availability of the products to children, thus filling the void in     pediatric HIV/AIDS therapy.   "
138744|NCT01468675|"     We evaluated whether collection of risk factors to generate an electronic health record     (EHR)-linked personalized health risk appraisal (HRA) for coronary heart disease (CHD),     diabetes, breast and colorectal cancer (CRC) was associated with improved patient-provider     communication, risk assessment, and breast cancer screening plans in the next year.   "
138686|NCT01469455|"     Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed     cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data     package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the     initiation of a phase I clinical study in this population. The recommended starting dose of     DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting     Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at     16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This     starting dose will be increased up to 96 mg if no DLT occurred during dose escalation.      DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections     in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg     oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a     week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose     escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design.      The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01     in association with palliative radiotherapy and to evaluate pharmacodynamics and the     anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration     of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after     the beginning of the DT01 treatment.   "
138687|NCT01469442|"     Aim : Effect of external biliary duct stent after hepatectomy on the occurence of     postoperative biliary fistula.      Methods : French prospective multicenter randomized trial. Population study: Adult patients     who underwent hepatectomy (> 2 segments) on non-cirrhotic liver.      Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a     external biliary duct stent. With this hypothesis, the number of patients required to be     equal to 152 per group for a total of 304 patients.      Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma,     biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat     biliary fistula, during of hospital stay and biliary fistula.      Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total     duration of the study is 3 years and 3 months.   "
138711|NCT01469117|"     This is a single center, prospective, non-randomized, uncontrolled, observational study of     the use of an enteral nutrition product in pediatric patients with developmental     disabilities.   "
138690|NCT01469403|"     The purpose of this study is to compare the efficacy in a group of patients who must follow     the current procedure for treatment of artificial knee, compared with a group of patients who     must undergo an 8-week weight loss program before surgery. 1 year after surgery the     investigators will examine whether there are differences between the two groups' quality of     life and functional capacity.   "
138691|NCT01469377|"     An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to     Antidepressant Therapy (ADT) in patients with Major Depressive Disorder (MDD) who have an     inadequate response to antidepressant alone. This clinical study will be comparing     cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate     response to ADT in the current episode. The study will consist of approximately 2 weeks of     screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week     safety follow-up.   "
138692|NCT01469364|"     This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI     can be safely and self-administered in lung transplant recipients with newly diagnosed     bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect     on lung function in order to appropriately design and power a larger multicenter randomized     study.      The hypothesis is that AZLI is a safe and effective treatment for declining lung function in     lung transplant recipients with early stage BOS.   "
138693|NCT01469351|"     Today Alzheimers disease can not be cured. Animal experiments have shown that the hormone     GLP-1 can improve memory in Alzheimer-prone mice.      The investigators hypothesis is that a 6-month treatment with the GLP-1 receptor stimulating     drug liraglutide will reduce the intracerebral amyloid deposition in the central nervous     system (CNS) in patients with Alzheimer's disease (AD) and thereby reduce the clinical     symptoms of the disease.   "
138694|NCT01469338|"     This phase II trial studies how well octreotide works in reducing diarrhea in patients     receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously     treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several     hormones in patients receiving chemotherapy for prostate cancer   "
138695|NCT01469325|"     Sequential left prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS), with high     frequency, for Treatment-Resistant Depression have been shown to have antidepressant effects.     but doubts remain about the magnitude of previously demonstrated treatment effects.The aim of     this study is To test whether daily weekday left prefrontal rTMS safely and effectively     treats Resistant Depression disorder compared to sham controls.   "
138696|NCT01469312|"     The objective of this study is to determine whether ingestion of modified pasta products     (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when     compared with a traditional pasta.   "
138721|NCT01468987|"     The purpose of this study is:        -  To compare blood sugar control on LY2605541 with insulin glargine after 26 weeks of          treatment.        -  To compare the number of night time low blood sugar episodes on LY2605541 with insulin          glargine during 26 weeks of treatment.        -  To compare the number of participants on LY2605541 reaching blood sugar targets without          low blood sugar episodes at night to those taking insulin glargine after 26 weeks of          treatment.        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin          glargine after 26 weeks of treatment.   "
138697|NCT01469299|"     The primary objectives of this evaluation are: 1) To attempt to refine the current clinical     understanding of balance 2) To determine if patients with quantifiably balanced knee joints     exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the     VERASENSE™ Knee System      Secondary objectives:        -  Determine whether a difference in inter-compartment loads and soft tissue tension exists          between the physicians intra-operative feel compared to the quantifiable data measured          by the VERASENSE™ Knee System        -  Determine which ligament releases are performed by the surgeon to improve soft tissue          balance while utilizing the information from the VERASENSE™ Knee System        -  Evaluate range of motion, pain, physical function, activity level, and patient          satisfaction between baseline (pre-operative) and post-operative follow-up as well as          radiographic success and survivorship of the knee implants   "
138698|NCT01469286|"     Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present     in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of     patients with functional dyspepsia that affects about 10%-25% of the general population.     Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of     gastroparesis include nausea, vomiting, early satiety and abdominal bloating.      Electroacupuncture (EA) is a combined procedure with acupuncture and electrical current     stimulation instead of manual manipulations of the needles. Recent studies in our lab with EA     or transcutaneous EA (TEA) have suggested a therapeutic role of EA or TEA for gastric     motility disorders. Improvement has been observed with EA or TEA in gastric emptying as well     as dyspeptic symptoms. In this project, a micro-stimulator is designed and developed for the     TEA therapy. The micro-stimulator is small enough so that it can be attached to the skin next     to the stimulation electrodes and therefore the patient can resume normal daily activity     while being treated by TEA. This is not only attractive but also more effective since TEA can     be performed more often and for longer durations.      This exploratory project is designed to study the feasibility, efficacy and certain     mechanisms of the proposed method of wireless TEA in patients with gastroparesis. Firstly     the feasibility of the chronic use the proposed micro-stimulator will be studied. Secondly,     the efficacy of the TEA in improving delayed gastric emptying and symptoms of gastroparesis     will be investigated in a double-blinded crossover design in patients with diabetic or     idiopathic gastroparesis. Thirdly, possible mechanisms involving pathogeneses of     gastroparesis with TEA will be investigated.   "
138699|NCT01469273|"     This interventional trial shall investigate the efficacy and tolerance of a suspension with     non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal     infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli     bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.   "
138712|NCT01469104|"     The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results     in a change in blood glucose that is similar to the change observed after 3 days of fasting.   "
138700|NCT01469260|"     The purpose of this study is to evaluate pedometer use by overweight women during pregnancy.     The study will show if a pedometer will help women to limit weight gain during pregnancy. It     will also show if it there are other benefits such as decreased diabetes, decreased high     blood pressure, decreased rates of cesarean section, and decreased complications for the     baby.   "
138701|NCT01469247|"     The goal of this clinical research study is to find a safe dose of radiation that can be     given to patients with brainstem glioma who have already received radiation therapy.      You will receive photon radiation therapy. This type of radiation is similar to the radiation     you have already had. Conformal radiotherapy or intensity modulated radiotherapy (IMRT) will     be used to try to treat the tumor while affecting as little of the surrounding normal tissue     as possible.   "
138702|NCT01469234|"     The purpose of this study is to determine the onset of action of two commercially available     over-the-counter antihistamines (Loratadine and      Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo     sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research     Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom     Complex (MSC) score will then receive drug.   "
138703|NCT01469221|"     This is an international, multicenter, double-blind, placebo-controlled, randomized study.     All eligible patients entering the open label phase of the study will receive a single     immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral     resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double     Blind Phase qualification, patients with confirmed eligibility will be randomized to receive     either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo     cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic     evidence of recurrent disease during the study will be treated according to current treatment     guidelines or local standard of care. Safety and efficacy assessments will be performed at 3     month intervals for all randomized patients throughout the study. Patients who receive single     dose of apaziquone immediately following TURBT and are not eligible for randomization will be     followed for 3 months by cystoscopic exam and safety assessments.   "
138704|NCT01469208|"     The investigators hope to determine if music therapy will have beneficial effects on     physiologic parameters, behavioral states, and pain scale evaluations in infants with     gastroschisis defects and if music therapy promotes parental/caregiver relaxation and     demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their     infant at risk for chronic gastrointestinal discomfort.      Babies will be enrolled during the perinatal period, with therapy to begin after surgical     repair of the gastroschisis defect and when the neonatologist deems the baby stable enough     for music therapy intervention. Enrolled subjects may receive up to 3 music therapy     sessions/week and these sessions may continue until discharge. There is no follow up after     discharge.      Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:        1. Pre music therapy behavior state will be assessed using CRIES scale and recorded.        2. Five minutes of baseline vital signs will be recorded.        3. Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap          harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be          maintained at 65-75dB. Session will stop if infant shows any signs of          distress/agitation. Vital signs will be collected every 1-4 minutes during music          session.        4. After session behavior state using CRIES scale will be recorded.        5. Family/caregiver will be given a questionnaire to fill out.        6. 30 min of quiet will start.        7. At the end of quiet time, behavior state and vital signs will be recorded for the last          time.   "
138705|NCT01469195|"     During fluoroscopic imaging, diagnostic information is carried in the primary beam. These     high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation     deviates in all directions from the patient. Despite typical precautions (i.e., hanging a     lead shield between the patient and the operator), many operators will be exposed to high     radiation dose (higher than the permitted 50 miliS per year), this long term radiation     exposure may result in stochastic and deterministic effects. The purpose of this study was to     test the hypothesis that a non disposable radiation protection drape (that will cover the     lower part of the patient) could help minimize the radiation scattered from the patient to     the operator. In a procedure done through the Radial approach, there is a large portion of     the patients (from the umbilicus and down) that is a source of scatter radiation to the     operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of     uniform thickness will be inserted into a sterile nylon bag and will be used during     fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover     the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm     respectively and was shown not to hinder the field of radiation needed for fluoroscopy and     cineangiography. (The upper border of the lead is under the patient's umbilicus and was shown     not to interfere with the radiation field needed for angiography or angioplasty).      The Investigators anticipate that the study will show a significant reduction in radiation     exposure and hence reduce the radiation hazard to the operator.   "
138706|NCT01469182|"     This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in     participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary     objective was to compare treatment-emergent adverse events (AEs) for participants treated     with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.   "
138707|NCT01469169|"     This study is to investigate the efficacy, safety, and Pharmacokinetics (PK) of Inhaled     Iloprost (Ventavis) therapy in Japanese pulmonary arterial hypertension (PAH) patients in     Main Treatment Phase (12 weeks) and to investigate the safety, tolerability, and efficacy of     longterm Inhaled Iloprost (Ventavis) therapy in Japanese PAH patients in Extension Phase.   "
138708|NCT01469156|"     This Phase I/II study will investigate the safety and tolerability of intravitreally     administered 0.5mg and 2.0mg Ranibizumab in three monthly doses followed by a 9 month period     of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects     with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.   "
138709|NCT01469143|"     This trial is conducted in Europe. The purpose of this trial is to compare the     pharmacokinetic properties (the exposure of the trial drug in the body) of different     formulations of NN1218.   "
138715|NCT01469065|"     This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2     diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and     pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to     wash off their diabetes medication for 4-6 prior to study drug administration, and they will     remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of     dosing, and some follow up tests.   "
138716|NCT01469052|"     The purpose of the study was to characterize the safety of investigational agent AG-013736,     in patients with solid tumors in this First In Human trial.   "
138717|NCT01469039|"     The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or     ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.   "
138718|NCT01469026|"     The purpose is to elucidate the value of PET/CT applied early in the work-up of patients with     a metastasising cancer of an unknown primary tumor.      The management of patients with metastasising cancer of unknown primary often includes     various and a large number of radiographic studies and invasive procedures, but the occult     primary tumor is detected in less than 20%.      Early PET/CT may be useful in Cancer of Unknown Primary (CUP) before expensive and invasive     diagnostic procedures are carried out. The outcome may be higher tumor detection rate and     quicker diagnosis, avoiding unnecessary, extensive procedures. Furthermore, a large number of     the patients will receive treatment aimed at the correct diagnosis. Therefore, a prospective     cost-effectiveness analysis is warranted.   "
138719|NCT01469013|"     This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension),     placebo-controlled, dose-ranging, parallel-group study of LY3009104 in Japanese participants     with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy. LY3009104     will be orally administered once a day with background methotrexate (6 to 16 mg/week) therapy     for 12 weeks in the double-blind treatment period (1, 2, 4 or 8 mg/day, or placebo), and for     52 weeks in the single-blind extension period (4 or 8 mg/day).   "
138720|NCT01469000|"     The purpose of this study is to compare the combination of pemetrexed and gefitinib versus     gefitinib alone, in terms of progression-free survival. This study is in participants who     have stage IV non squamous NSCLC with activating epidermal growth factor mutations and who     have not had any previous chemotherapy for stage IV disease.   "
138723|NCT01468961|"     This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The     purpose of the study is to evaluate an internet-based treatment protocol based on cognitive     behavioral therapeutic principles. Participants are required to have a previous diagnosis of     fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all     included participants will be given treatment, i.e. there is no randomization to a comparison     group.   "
138724|NCT01468948|"     Background:      - Essential tremor (ET) is a condition of out-of-control shaking. Several drugs are used to     treat ET. However, they are often only partly helpful and can have side effects. Many people     with ET get some relief from drinking alcohol. Octanol, a food additive similar to alcohol,     can improve tremor in animals and is less likely to make people feel drunk. One form of     octanol, called 1-octanol, has been shown to improve tremor in some people and had few side     effects. 1-octanol is converted to octanoic acid, and research suggests that octanoic acid     itself might suppress ET with no significant side effects such as drunkenness. Researchers     want to see what dose of octanoic acid is most useful in reducing ET.      Objectives:      - To test different doses of octanoic acid to treat essential tremor.      Eligibility:        -  Individuals at least 21 years of age who have ET that responds to treatment with          alcohol.        -  Participants must be able to stop taking certain ET medications during the study.      Design:        -  This study requires three visits. Visit 1 is a screening visit that will take up to 5          hours. Visit 2 is a 2- to 3-day inpatient admission to the National Institutes of Health          Clinical Center. Visit 3 is a followup outpatient visit 1 to 2 weeks after the hospital          admission.        -  At the screening visit, participants will have a physical exam, neurological exam, and          medical history. Blood and urine samples will be collected. Participants will also have          an alcohol dose test to measure the tremor s response to alcohol.        -  For the study visit, participants will enter the hospital for testing. Participants will          have the study drug and test the tremor's response to it. Frequent blood samples will be          collected.        -  One to two weeks after leaving the hospital, participants will have a final followup          study visit. Blood samples will be collected.   "
138725|NCT01468935|"     Background:      - Some transplant recipients have been found to have cells in their uterus that come from the     donor. Researchers want to study uterine tissue from three different groups of women: (1)     healthy volunteers, (2) people who have had a stem cell transplant, and (3) people with rare     diseases or conditions that affect reproduction. These samples will help researchers learn     more about the way stem cells work in the reproductive tract.      Objectives:      - To collect cells from the uterus to study how stem cells work in the reproductive tract.      Eligibility:      - Women at least 18 years of age.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests.        -  Participants will have an endometrial biopsy to collect cells for study. The biopsy          visit will take 1 to 2 hours.   "
138726|NCT01468922|"     Background:      - Pazopanib is an anticancer drug that blocks the growth of new blood vessels in tumors. It     has been approved to treat renal cell cancer. ARQ 197 is an experimental drug that blocks a     protein called c-MET, which cancer cells need to grow. Studies suggest that some drugs that     block blood vessel growth can increase the production of c-MET in tumors, which helps cancer     cells keep growing. Blocking both blood vessel growth and c-MET with pazopanib and ARQ 197     may help kill cancer cells faster. This study will use these drugs to treat solid tumors that     have not responded to earlier treatments.      Objectives:      - To test the safety and effectiveness of pazopanib and ARQ 197 for advanced solid tumors.      Eligibility:      - Individuals at least 18 years of age who have advanced solid tumors that have not responded     to earlier treatments.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests, and imaging studies.        -  The study drugs will be given in 4-week cycles of treatment. Participants will take          pazopanib once a day and ARQ 197 twice a day by mouth. Some participants will start with          pazopanib or ARQ 197 alone for the first week. Then they will take both drugs together          for the rest of the study.        -  Participants will be monitored with frequent blood tests and imaging studies. Optional          tumor samples may be collected during different treatment cycles....   "
138759|NCT01468480|"     Application of four different pulp capping methods on human sound premolars after intentional     exposure of the buccal pulp horn through a class one occlusal cavity.   "
138760|NCT01468467|"     The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy     after treatment with an allogeneic stem cell transplant.   "
138727|NCT01468909|"     This randomized phase II trial studies how well paclitaxel when given together with or     without pazopanib hydrochloride works in treating patients with ovarian epithelial, fallopian     tube, or peritoneal cavity cancer that is persistent or has come back. Drugs used in     chemotherapy, such as paclitaxel work in different ways to stop the growth of tumor cells,     either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking blood flow     to the tumor or by blocking some of the enzymes needed for cell growth. It is not yet known     whether paclitaxel is more effective when given with or without pazopanib hydrochloride in     treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.   "
138728|NCT01468896|"     This phase I/II trial studies the side effects and best dose of recombinant interleukin-12     when given together with cetuximab and to see how well they work in treating patients with     squamous cell carcinoma of the head and neck that has come back, spread to another place in     the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the white     blood cells to kill tumor cells. Monoclonal antibodies, such as cetuximab, may interfere with     the ability of tumor cells to grow and spread. Giving recombinant interleukin-12 together     with cetuximab may kill more tumor cells.   "
138729|NCT01468883|"     Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to     receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2)     excisional biopsy, axillary dissection, and definitive irradiation.      Data from single institutions and from retrospective comparisons suggest that definitive     irradiation with cosmetically acceptable breast preservation offers survival and local     control results equivalent to extirpative surgery. This study will test this hypothesis in a     prospective, randomized manner. After primary therapy, subjects will be followed for: (1)     survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and     (5) cosmesis.   "
138745|NCT01468662|"     The investigators propose to conduct a study to measure the reproducibility of CMR parameters     that have been used to predict outcome following PPCI: infarct size, left ventricular     volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.   "
138746|NCT01468649|"     The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph     node (SLN) identification in patients with breast cancer using near-infrared (NIR)     fluorescence optical imaging.   "
138747|NCT01468636|"     The purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on     genital warts. Our hypothesis is that there will be a 10% difference in complete clearance of     genital warts in the group randomized to oral plus standard of care compared to those     randomized to placebo plus standard of care.   "
138730|NCT01468857|"     Background:      - Stem cell transplants are a complex treatment that can have serious side effects. Having a     caregiver to help with the recovery is critical. Serving in this role, however, can cause     high stress levels and negative health effects. Researchers want to better understand the     health effects of caring for a family member or friend after a stem cell transplant.     Understanding these effects can help develop programs that support caregivers coping with the     demands of post-transplant care.      Objectives:      - To study the physical and emotional health of caregivers for a family member or friend who     has had a stem cell transplant.      Eligibility:        -  Individuals at least 18 years of age who are planning to be a caregiver for a person          having a stem cell transplant.        -  Healthy non-caregiver volunteers for comparison studies.      Design:        -  A caregiver will be caring for a transplant recipient just before transplant admission          and up through 6 weeks after hospital discharge. The caregiver will usually live with or          spend at least 6 hours each day with the recipient.        -  All participants will have three study visits. The first visit will happen before the          transplant. The second and third visits will happen at the recipient s discharge, and 6          weeks after discharge. The following tests will be done at each visit:        -  A health assessment with a physical exam and review of life events and current health          problems        -  Blood, hair, and saliva samples        -  Questionnaires about stress levels, personal health, and the caregiving process.        -  Caregiver participants may have an optional fourth study visit within 72 hours after an          ICU admission. This visit will include the same tests as the other visits.   "
138731|NCT01468844|"     Background:      - Central retinal vein occlusion (CRVO) is a blockage of the main vein that carries blood     away from the retina in the back of the eye. It can lead to macular edema, a swelling of the     retina that is a common source of vision loss. Studies suggest that inflammation might be a     cause. Minocycline is a drug that might help prevent cells involved in inflammation from     becoming activated. It is approved for use as an antibiotic, but it has not yet been tested     to see if it can treat CRVO.      Objectives:      - To test the safety and effectiveness of minocycline as a treatment for central retinal vein     occlusion.      Eligibility:      - Individuals at least 18 years of age who have central retinal vein occlusion in at least     one eye, with vision between 20/32 and 20/200.      Design:        -  This study lasts 2 years, with at least 25 visits. Participants must agree to protect          themselves from sunlight or artificial ultraviolet rays while in this study.        -  Participants will be screened with a physical exam and medical history. They will also          have blood tests and an eye exam. One eye will be selected as the study eye to receive          the medicine.        -  Participants will take minocycline or a placebo pill twice a day, about 12 hours apart,          for 2 years.        -  Participants will have monthly visits for blood tests and full eye exams to study the          effect of the treatment. Other exams may include thyroid tests and eye imaging studies.          Those in the study may also receive injections of a drug to prevent the growth of new          blood vessels in the eye....   "
138761|NCT01468454|"     Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these     children may require surgery to remove part or all of their pancreas. In this study,     researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine     (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery.     Eligible participants in this study will have positron emission tomography/computerized     tomography (PET/CT) scans with F-DOPA prior to surgery.   "
139477|NCT01459029|"     The purpose of this study is to compare efficacy and safety of add-on treatment with a     moderately high dose of D-serine, an NMDA-glycine site agonist, in young, recent onset     schizophrenia patients who suffer from significant symptoms despite treatment with     antipsychotics.   "
138732|NCT01468831|"     Background:      - Branch retinal vein occlusion (BRVO) is a blockage of the small veins that carry blood away     from the retina in the back of the eye. It often leads to macular edema, a swelling of the     retina that is a common source of vision loss. Studies suggest that inflammation might be a     cause. Minocycline is a drug that might help prevent cells involved in inflammation from     becoming activated. It is approved for use as an antibiotic, but it has not yet been tested     to see if it can treat BRVO.      Objectives:      - To test the safety and effectiveness of minocycline as a treatment for branch retinal vein     occlusion.      Eligibility:      - Individuals at least 18 years of age who have branch retinal vein occlusion in at least one     eye, with vision between 20/32 and 20/200.      Design:        -  This study lasts 2 years, with at least 25 visits. Participants must agree to protect          themselves from sunlight or artificial ultraviolet rays while in this study.        -  Participants will be screened with a physical exam and medical history. They will also          have blood tests and an eye exam. One eye will be selected as the study eye to receive          the medicine.        -  Those in the study will take minocycline or a placebo pill twice a day, about 12 hours          apart, for 2 years.        -  Participants will have monthly visits for blood tests and full eye exams to study the          effect of the treatment. Other exams may include thyroid tests and eye imaging studies.          Those in the study may also receive injections of a drug to prevent the growth of new          blood vessels in the eye.   "
138733|NCT01468818|"     Background:        -  The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy          that involves taking white blood cells from patients' tumors, growing them in the          laboratory in large numbers, and then giving the cells back to the patient with          aldesleukin (IL-2) a drug that keeps the white blood cells active. These cells are          called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment          to over 200 patients with melanoma.        -  This study will use chemotherapy to prepare the immune system before this white blood          cell treatment. Our prior studies indicate that aldesleukin may not be required for cell          transfer.      Objectives:      - To see if chemotherapy and white blood cell therapy without aldesleukin is a safe and     effective treatment for metastatic melanoma.      Eligibility:      - Individuals at least 18 years of age and less than or equal to 70 years of age with     metastatic melanoma.      Design:        -  Work up stage: Patients will be seen as an outpatient at the National Institute of          Health (NIH) clinical Center and undergo a history and physical examination, scans,          x-rays, lab tests, and other tests as needed.        -  Surgery: If the patients meet all of the requirements for the study they will undergo          surgery to remove a tumor that can be used to grow the TIL product.        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood          cells. {Leukapheresis is a common procedure, which removes only the white blood cells          from the patient.}        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the          hospital for about 4 weeks for the treatment.        -  Follow up: Patients will return to the clinic for a physical exam, review of side          effects, lab tests, and scans about every 1-3 months for the first year, and then every          6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up          to 2 days.   "
138748|NCT01468623|"     The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU     versus standard Body Surface Area (BSA) based administration of 5-FU in patients with     metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine     if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to     BSA dosing response.   "
138749|NCT01468610|"     This study will investigate the relationships between subjective cognitive complaints,     neurocognitive deficits, and work productivity in participants with Major Depressive Disorder     (MDD), before and after 8 weeks of treatment with an antidepressant medication. Our     hypothesis is that, in working participants with MDD of at least moderate severity,     neurocognitive deficits will predict poorer work functioning and productivity.   "
138734|NCT01468805|"     Background:      - Cockroach allergies are an important risk factor for asthma in inner-city households,     especially in children. A new method for killing cockroaches may help children who live in     households that have high numbers of cockroaches. Because most public health treatments     target more than just cockroaches, this method could lower the costs of treating childhood     allergies and asthma by focusing on the most likely source of the allergy.      Objectives:      - To test a new cockroach-killing method designed to reduce asthma in children exposed to     cockroaches.      Eligibility:        -  Children 5 to 14 years of age who have moderate to severe asthma.        -  Children must live in a household that has a high number of cockroaches.      Design:        -  Participants will be screened with a phone call and an initial home visit.        -  Study doctors will place cockroach traps, and return after 3 days to check the number of          roaches caught and killed. Dust samples will be collected from the house.        -  Participants will have blood and lung function tests, and will be tested for allergies          (including cockroach allergies).        -  Some households will be treated for cockroaches at regular intervals, or more frequently          if required by the study doctors.        -  Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and          12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma          symptoms. The home visits will also check the cockroach levels in the house.   "
138735|NCT01468792|"     The study serves the identification of early forms of pulmonary arterial hypertension (PAH)     in connective tissue disease and the hemodynamic follow-up of the investigated patients. The     basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which     leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a     disproportional increase in pulmonary pressure during exercise. Recent studies have shown     that a proportion of such patients may develop manifest PAH within a few years. The early     identification of these patients and the understanding of the natural course of the disease     may improve prognosis. The aim of the present study is to investigate hemodynamic and     clinical changes in patients with connective tissue disease in a time interval of 3-5 years     with a focus on the development of pulmonary hypertension.   "
138736|NCT01468779|"     The purpose of this study is to evaluate the effect of the probiotic use in patients with     periampullary cancers undergone curative or palliative treatment considering nutritional     status, postoperative complications, infection rate, length of hospitalization and mortality.   "
138737|NCT01468766|"     The purpose of this randomized intervention study is to investigate the effects and     biological mechanisms of a supervised 12-week progressive resistance training on fatigue and     immunological and inflammatory biomarkers in breast cancer patients during adjuvant     radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial     effects due to attention by trainers or the group support, patients in the control group have     a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation     training (Jacobsen method).   "
138739|NCT01468740|"     Standard therapy for HIV-related Hodgkin lymphoma (HIV-HL) has not been defined. This trial     was initiated to investigate a risk adapted treatment strategy in patients (pts) with HIV-HL     as established in HIV-negative patients with HL.      Treatment schedule:        -  Early stage favorable Hodgkin Lymphoma (HL): 2 cycles of doxorubicin, bleomycin,          vinblastine, and dacarbazine (ABVD) plus 30 Gy involved field (IF) radiation        -  Early stage unfavorable HL: 4 cycles of bleomycin, etoposide, doxorubicin,          cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline or 4          cycles of ABVD plus 30 Gy IF radiation        -  Advanced HL: 8 cycles of BEACOPP-baseline. BEACOPP should be replaced by ABVD in pts          with far advanced HIV-infection. After the completion of chemotherapy sites of initial          bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in          diameter receive 30 Gy of irradiation.        -  Primary outcome measure: tolerability, treatment-related mortality        -  Secondary outcome measure: complete remission rate, progression-free survival (PFS),          overall survival (OS).   "
138740|NCT01468727|"     Mutans streptococci (MS) and lactobacillus species (LB) are the two groups of infectious     cariogenic (caries-causing) bacteria most strongly associated with dental caries (dental     decay). Infants acquire cariogenic bacteria from their mothers early in development via     saliva. There have been several studies that have demonstrated a significant reduction in     dental caries associated with consumption of the food additive known as xylitol in children     and adults. Xylitol is a non-toxic 5 carbon polyol, approved as a food additive by the FDA,     that tastes like and behaves like sucrose in humans. Xylitol is used as a sugar substitute to     reduce dental caries as it is not fermentable by the caries causing bacteria. In addition, an     observed positive beneficial side effect of this sugar substitute is that xylitol has been     shown to reduce mother to child bacterial transfer when used by the mother. It is commonly     recommended to wipe infants' teeth and gums with a soft cloth to reduce the formation of     dental bacterial plaque. Recently wipes have been marketed that contain xylitol to provide a     safe sweet sensation for the infant during this cleaning procedure. However, no study has     been conducted that assesses the biological effect of applying xylitol directly to the teeth     and gums of infants. This study will be conducted to test whether xylitol applied by swab     directly to the infant's teeth and gums will effectively reduce bacterial transfer from     mother to child. Children age up to two years old whose mothers have high cariogenic     bacterial counts will be recruited to use xylitol wipes 3-4 times daily in addition to their     normal preventive regimen. This will be a randomized double blinded study where the control     group will receive placebo wipes (with no xylitol) and the experimental group will receive     the xylitol wipes. The mother-child pair MS and LB bacterial counts and caries score of the     children will be measured at baseline, 3 months, 6 months and 1 year. We will contact all     patients that were recruited into the study to inquire whether they are willing to return for     further follow-up visits at 1, 2, 3, and 4 years post-wipe treatment completion. If     successful, this study will support the use of a simple caries preventive measure that could     be easily and safely implemented in young children. Ten MS isolates and unique LB colonies     will be isolated from each saliva samples to study their genetic diversities and virulence     factors.      The investigators will also investigate whether specific MS genes relate to ECC prevention     effect of daily xylitol-wipe application using genomic sequencing of MS isolated from current     study when the active intervention was applied.   "
138741|NCT01468714|"     This study will evaluate the potential for a drug-drug interaction of PF-04937319 with     ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.   "
138742|NCT01468701|"     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at     risk for stroke are enrolled to characterize the target population and to collect real world     data on important outcome events. For administrative purposes the study is divided into two     protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic     Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled     in both protocols is estimated to be 48,000 patients, and all these patients will be included     in the data analysis for study 1160.129.   "
138752|NCT01468571|"     The purpose of this study is to determine the effects of spironolactone on collagen markers     in a large number of patients with pulmonary hypertension. In addition, safety and     tolerability of spironolactone, an aldosterone receptor antagonist, in patients with     pulmonary arterial hypertension, will be determined.   "
138753|NCT01468558|"     Compare the DHE pharmacokinetic profiles observed following administration of:        1. MAP0004 (oral inhalation DHE)        2. MAP0004 co-administered with oral Ketoconazole        3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)      Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of     Ketoconazole.   "
138754|NCT01468545|"     Ventavis it's a treatment for pulmonary hypertension, administered by an inhaler called     I-Neb.      In these patients, the non compliance of the treatment becomes its ineffective and increases     the complications and mortality of the disease.      It is therefore important to know which the adherence of patients to their treatment is and     try to promote it.      One possibility to reach a good level of adherence is the patient education regarding the     drug administration and also to comply as better is possible the recommendations of the     physician.      For this reason, the objective of our study is to demonstrate improvement in the level of     treatment compliance when they follow a strategy of continuing education, assessed by the     device and software called Insight.      The only special procedure to participate in the study then is that patients involved could     receive more training than usual.      Investigators expect involving in this study around 50 patients in treatment with Ventavis     and diagnosed of Pulmonary Arterial Hypertension in 10-12 hospitals throughout Spain.      The patients who participated in the study will be followed for 12 months from inclusion in     the study and will perform around 5 visits in total.   "
138755|NCT01468532|"     This phase I/II trial studies the side effects and best dose of pasireotide and to see how     well it works when given together with docetaxel and prednisone in treating patients with     metastatic hormone-resistant prostate cancer. Drugs used in chemotherapy, such as docetaxel     and prednisone, work in different ways to stop the growth of tumor cells, either by killing     the cells or by stopping them from dividing. Pasireotide may inhibit the secretion of     hormones. Giving pasireotide together with docetaxel and prednisone may kill more tumor     cells.   "
138756|NCT01468519|"     Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with     diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with     diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic     control increases the risk ED. Although comparatively costly, advantages of CSII over other     modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and     improved quality of life. In a previously published study, on CSII in T2DM, in our center,     83% of men reported an improvement in sexual function as a secondary endpoint. The current     study is planned to further explore this finding.   "
138757|NCT01468506|"     The purpose of this study is to analyze and identify pre-, intra-, and post- operative     parameters that predict Steal-Syndrome with distal malperfusion after Arterio-Venous Fistulas     (AVF) as primary endpoint. Secondary endpoints are pre-, intra-, and post- operative     parameters that predict patency and fistula maturation.   "
138762|NCT01468441|"     The present prospective study was designed to compare the effects of administering a daily     dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH     agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated     with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG)     microdose.   "
138763|NCT01468428|"     In patients with Cystic fibrosis (CF) epithelial transport of chloride and sodium is     disrupted in several organs such as airways, sweat glands, pancreas and intestines.     Gastrointestinal symptoms are frequent but little is known about intestinal motility and     function. Earlier studies using lactulose/hydrogen breath tests have found altered intestinal     transit time. The method has several sources of errors and results have been questioned. This     study is using a new, non invasive method to study intestinal motility patterns and transit     times, Magnetic Tracking System - 1 (MTS-1).      The aim is to compare patterns of contractility and transit times in the stomach and small     intestine in adult CF- patients with healthy controls.      Methods MTS-1 is performed without radiation and is associated with minimal discomfort for     subjects. A small magnetic pill is ingest and detected by a matrix of sensors. Position and     orientation of the magnet are defined by five coordinates (position: x, y, z, angle: φ, θ).     Frequencies of slow waves as well as number and power of phase III contractions can be     identified.      Colorectal transit times are determined with a plain abdominal x-ray. The subjects are asked     to ingest a capsule containing 10 radiopaque markers on six consecutive days up to     examination. The total number of markers in the entire colorectum is counted. Total transit     time, as well as segmental is calculated.      Subjects 15 adult patients (> 18 years) with CF, homozygote for the mutation ΔF508, are     studied. They are all pancreas insufficient (fecal elastase < 100 µg/g), with no previous     intestinal resection or lung transplantation. None of them have diabetes. Patients are all in     well-regulated pancreatic enzyme replacement therapy (PERT), thriving and with stabile weight     over the last half year. They have had no treatment with antibiotics in the last 14 days up     to the examination.      The hypothesis is that patterns of contractility and transit times are the same for     CF-patients in well -regulated PERT as for healthy controls.   "
138764|NCT01468415|"     The American Society of Anesthesiologists Task Force on Management, Chronic Pain section,     recommended Phenol neurolysis when other techniques have failed to provide adequate pain     control. In this study we sought to Compare the pain relieve on a Lower Back and Limbs     obtained from Methylprednisolone and Phenol 8% Treatment given by Trans Sacral Approach. The     study includes patients who suffers from a chronic low back and/or limbs pain which were     referred to be given epidural as a treatment. Control group receives 80 mg Methylprednisolone     while the test group receives phenol 8%.   "
138768|NCT01468363|"     There is no easily applicable method to determine extra cellular volume and consequently     estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several indirect     methods.      Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available.     This non-invasive, cheap easily repeatable method has the potential to improve dialysis     outcome in the majority of patients all over the world, The aim of the present project is to     assess the feasibility of volume control by using a BİS device.   "
138769|NCT01468350|"     A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to     evaluate the safety and tolerability and the effect of dalfampridine extended release (ER)     tablets on sensorimotor function   "
138770|NCT01468337|"     Background:      - In the eye disease central serous chorioretinopathy (CSC), fluid collects under the retina     at the back of the eye. CSC can resolve on its own, but in some people it lasts for several     months or can come back. The fluid buildup during CSC can cause vision loss. The drug     interferon gamma-1b can help reduce fluid accumulation in the retina. Researchers want to see     if interferon gamma-1b can help treat and prevent vision loss from CSC.      Objectives:      - To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC.      Eligibility:      - Individuals at least 18 years of age who have CSC in at least one eye.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have an eye exam and blood tests.        -  This study will require at least ten visits to the National Institutes of Health eye          clinic over a total of 52 weeks (one year). Most visits will last up to 4 hours.        -  Participants will return to the eye clinic 2 days after the first visit and 1, 2, 4, 8,          12, 24, 36 and 48 weeks after starting the study eye drops. These visits will involve          blood tests and eye exams.        -  Participants will receive the study eye drops at the initial visit. The drops must be          used three or four times a day for 2 weeks. They must be stored in a cool place (like a          refrigerator). The doses will follow an escalation schedule with the first participant          receiving 2 drops three times a day and the last participant receiving 4 drops four          times a day. To maximize safety, the most-recently enrolled participant will complete          Week 4 before the next participant can enroll (e.g., the second enrolled participant          will not be enrolled until the first has completed the Week 4 visit).        -  If the CSC does not improve after the first 2 weeks, participants will receive another 2          weeks of eye drops. This set of drops will start 4 weeks after the initial study visit.        -  If the CSC does not improve after the 8-week study period, participants may receive          additional eye drops at the maximum dose of 4 drops four times daily.        -  The study will end for each participant at one year (48 weeks after the initial study          visit).   "
138771|NCT01468324|"     Background:      - AZD7451 is a drug that may help interfere with brain tumor cell growth. It can prevent     glioma cells from entering into normal brain tissue, and slow or stop the growth of     additional tumors. Researchers want to see if AZD7451 is effective against gliomas that have     not responded to surgery, radiation, or chemotherapy.      Objectives:      - To see if AZD7451 is a safe and effective treatment for gliomas that have not responded to     standard treatments.      Eligibility:      - Individuals at least 18 years of age who have gliomas that have not responded to standard     treatments.      Design:        -  Participants will be screened with a physical exam, medical history, blood and urine          tests, heart function tests, an eye exam, and imaging studies.        -  Participants will take AZD7451 daily by mouth for 28-day cycles of treatment.        -  Participants will keep a medication diary and record any side effects. Treatment will be          monitored with frequent blood tests and imaging studies.        -  Treatment will continue as long as there are no serious side effects and the tumor does          not start growing again....   "
138772|NCT01468311|"     Background:        -  Hodgkins lymphoma (HL) is a highly treatable cancer. However, if HL does not respond to          chemotherapy or returns after chemotherapy, further treatments often are not successful.        -  Some HL cells have a molecule called cluster of differentiation 25 (CD25) on the          surface. Daclizumab is a drug that can detect CD25 on cells. In a treatment study for HL          that did not respond to chemotherapy, daclizumab plus a radioactive atom called Yttrium          90 helped kill these HL cells. Researchers want to combine this 90Y daclizumab with          high-dose chemotherapy and stem cell transplant. This treatment may be more effective          than the daclizumab alone.      Objectives:      - To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can     treat HL that has not responded to earlier treatments.      Eligibility:      - Individuals at least 18 years of age who have Hodgkins lymphoma that has not responded to     chemotherapy.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests.        -  Participants will have filgrastim and plerixafor to move stem cells into the blood. Stem          cells will be collected with apheresis.        -  Four weeks after stem cells are collected, participants will have the 90Y daclizumab and          normal daclizumab to treat the HL. Chemotherapy will start 9 days after the first          treatment.        -  Most participants will have a second dose of 90Y daclizumab 6 weeks after the first          dose.        -  After each daclizumab treatment, participants will have several imaging studies of the          chest and abdomen. Blood samples will also be collected.        -  On the day after the last day of chemotherapy, participants will receive the stem cells          collected earlier. Filgrastim injections will help stimulate stem cell growth....   "
138773|NCT01468298|"     The aim of this study was to investigate the changes in posture, flexibility, muscle     strength, functional capacity, heart rate(HR), peripheral oxygen saturation, systolic blood     pressure, diastolic blood pressure and intensity of pain in chronic low back pain underwent     to Isostretching and GPR.   "
138774|NCT01468285|"     Betahistine may provide benefit by enhancement of Cerebral Blood Flow (CBF). This     placebo-controlled pharmacodynamic treatment study will primarily explore the effect of     betahistine on cerebral blood flow measured by dynamic contrast-enhanced MRI imaging, in a     patient population with MRI evidence of cerebrovascular compromise. Also it will be measured     if CBF changes correlate with gait and cognitive changes.   "
138775|NCT01468272|"     This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of     Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation     already approved in adults.   "
138776|NCT01468259|"     This study will be an open-label, single-treatment, single-dose, parallel group study to     evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe     renal dysfunction and End Stage Renal Disease (ESRD) after a single dose compared to matched     healthy subjects with normal renal function.      A total of 48 male or female subjects, 16 subjects with normal renal function (eGFR greater     than 90 mL/min/1.73m²) and eight each (8) with mild (60 less than eGFR less than 89     mL/min/1.73m²), moderate (30 less than eGFR less than 59 mL/min/1.73m²), or severe (15 less     than eGFR less than 29 mL/min/1.73m²) renal impairment or ESRD (eGFR < 15 mL/min/1.73m² and     requiring hemodialysis) will be selected according to the inclusion and exclusion criteria.     The medical and laboratory examinations will take place within 28 days before dosing. A     single dose of 600 mg of droxidopa as an investigational drug will be administered with 240     mL of water after an overnight fast (minimum 10 hours).      Blood samples for the measurement of plasma concentrations of droxidopa and metabolites     including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be     collected before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours after dosing     for healthy volunteers and subjects with mild, moderate, and severe renal impairment and     those with ESRD. For the latter, samples will be collected on both a non-hemodialysis and a     hemodialysis visit.      During dialysis, samples of dialysate, from the arterial and venous sides of the dialyzer     will be collected at 30-minute intervals during the dialysis period. In addition, the entire     dialysate will be collected, its volume recorded, and a sample retained for the measurement     of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and     protocatechuic acid concentrations.      Urine samples for the measurement of urinary excretion of droxidopa and metabolites including     but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected     before and over the following intervals after dosing: 0 2, 2-4, 4-6, 6-8, 8-12, 12-24, and     24-36 hours for healthy volunteers and subjects with mild, moderate, and severe renal     impairment.      A post-study visit with physical examination and laboratory tests will take place within     seven (7) days after the last PK blood sampling.   "
138792|NCT01468051|"     Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled     and this could improve seroconversion rate of hepatitis B vaccination.      In this study, the investigators aimed to compare seroconversion rates and immune response     rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B     surface antigen (HBsAg) vaccine given to predialysis CKD patients.   "
138777|NCT01468246|"     The investigators are conducting a longitudinal cohort study of young women with breast     cancer. The investigators identify women age 40 and younger with newly-diagnosed breast     cancer from academic and community healthcare institutions. After women consent to the study,     they fill-out surveys and give blood samples, and the investigators collect tissue from their     breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3     years after diagnosis, then yearly thereafter for an additional 7 years (for a total     follow-up of at least 10 years following diagnosis). The study investigates short and     long-term disease and treatment issues, tumor biology and the relationship to patient     outcomes, and psychosocial concerns at baseline and in follow-up among a cohort of young     women who are newly-diagnosed with breast cancer.   "
138778|NCT01468233|"     A study to evaluate the safety and efficacy of treatment with adalimumab in adults with     moderate to severe hidradenitis suppurativa (HS).   "
138779|NCT01468220|"     The patient numbers with metabolic syndrome and diabetes have doubled in the last decade.     Data that physical exercise ameliorates the metabolic syndrome are convincing, although the     mechanisms of the effect in man are not clear. Numerous endocrine or molecular mechanisms     modified by physical exercise are known to be hypoxia-sensitive, i.e. by hypoxia-inducible     factor-1 (HIF-1) regulation. Thus, relative hypoxia may link physical exercise and     modification of endogenous metabolism. Medical communities seem ill equipped to address the     primary issues involved. The investigators have experience with normobaric hypoxia chambers     and will now test a (physical exercise) training program, using state-of-the-art assessments     available nowhere else in Germany. The investigators will compare hypoxia chamber, to ambient     training, to test the notion that specific exercise conditions could regulate specific     molecular pathways involved in the pathogenesis of the metabolic syndrome. Indeed, hypoxia     chamber training could be superior to conventional training in terms of reducing     cardiovascular risk factors or improving fitness. The investigators will test overall     metabolism-related effects with a metabolic chamber. The investigators will test local     metabolism with microdialysis during exercise routines, and the investigators will perform     fat and muscle biopsies to investigate tissue-related effects. The investigators include     experience from a broad-ranging spectrum. The investigators findings might improve     understanding mechanisms linking physical exercise and endogenous metabolism. Furthermore,     they could influence decision-making regarding non-pharmacological interventions.   "
138780|NCT01468207|"     A study to evaluate the safety and efficacy of treatment with adalimumab in adults with     moderate to severe hidradenitis suppurativa (HS).   "
138781|NCT01468194|"     In this investigation the researchers explore whether different types of breathing procedures     can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain     sickness or a high altitude pulmonary edema.   "
138782|NCT01468181|"     This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study     in participants with type 2 diabetes mellitus who have inadequate glycemic control with     monotherapy of oral antihyperglycemic medication (OAM).   "
138783|NCT01468168|"     To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye     disease.   "
138784|NCT01468155|"     It is hypothesized that peri-ablation Dabigatran will be a safe and effective method of     peri-procedural anticoagulation for Atrial Fibrillation (AF) ablation, resulting in a low     rate of peri-procedural bleeding and thromboembolic complications.   "
138785|NCT01468142|"     The purpose of this study is the observation of the course of        -  the mechanics of the respiratory system        -  the endexpiratory lung volume        -  and the inflammatory response in patients undergoing treatment with extracorporeal life          support (ECLS) due to severe refractory respiratory failure at our department.   "
138786|NCT01468129|"     This study will investigate the efficacy of using cell saver during bilater total hip     arthroplasty   "
138787|NCT01468116|"     Roux-en-Y gastric bypass (RYGB) surgery induces resolution of type 2 diabetes, often within     days after surgery and before significant weight loss. The aim of this study is to     investigate whether changes in mitochondrial function contributes to the early improvement of     type 2 diabetes after RYGB.   "
138788|NCT01468103|"     This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and     surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle     closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for     3 years.   "
138789|NCT01468090|"     The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562     adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in     order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort     is established after the implementation of biological agents in the treatment of IBD and the     investigators hypothesis is that a) Severe disease course in IBD can be predicted by     phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to     be used as guidance in the selection of treatment strategy and b) Introduction of biological     treatment changes the course of disease in IBD and reduces the need of surgical procedures.      Methods: Medical records will be reviewed to register the use of medication, flare ups     (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior     will be evaluated. At outpatient visits patients will get a clinical examination, blood and     faeces will be collected to biobank and patients will be offered an endoscopical examination.     The Montreal classification, The Harvey & Bradshaw's activity index (CD) and the SCAAI score     (UC) will be used to describe disease localization, extent, behavior and severity. An     electronic database will be established in use of processing data.   "
138790|NCT01468077|"     This multi-center, randomized, parallel-group, active-controlled, open-label study will     evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time     compared to the normal infusion time. Patients will be randomized to 8 mg/kg     RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg     infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.   "
138791|NCT01468064|"     The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous     transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial     progenitor cells (EPCs) for treatment of patients with ischemic stroke.   "
138793|NCT01468038|"     This is a double blind placebo controlled study of one hundred and four subjects which will     be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone     and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups.     Each of the one hundred and four subjects will undergo baseline examination to include a     sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and     four subjects will then be randomly placed in one of the four groups.   "
138794|NCT01468025|"     This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug     (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and     tolerability of Theramine alone in patients with chronic back pain in comparison to the     NSAID, Naproxen, and the co-administration of Naproxen with Theramine.   "
138795|NCT01468012|"     The proposed study will look at cocaine dependent individuals and will consist of three     consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy     will be administered; 2) the 15-21 day inpatient phase (during which participants will start     study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging     and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE     may reverse baseline brain deficits and if this change is associated with clinical     improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence     from cocaine over a 12-week trial in combination with behavioral treatment with voucher     incentives.   "
138796|NCT01467999|"     The purpose of this study is to determine whether guanfacine represents a tolerable,     potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing     whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving     as compared to baseline.   "
138797|NCT01467986|"     Children, adolescents and young adults with high risk relapsed or treatment refractory     neuroblastoma (rNB) represent a group of patients with dismal prognosis for whom a     recommended standard salvage therapy is currently not available.      The multimodal metronomic approach combining molecular targeted drugs (rapamycin and     dasatinib) with conventional chemotherapy (irinotecan and temozolomide) will be investigated     in a randomized fashion as new treatment strategy for patients with rNB. The intention is to     assess the therapeutic benefit of molecular targeted drugs for the treatment of rNB.      The combination of irinotecan and temozolomide showed activity in the treatment of several     solid organ tumors, brain tumors and neuroblastoma. In one study rNB patients received a     median of 5 courses of 5 days irinotecan and temozolomide every 3 to 4 weeks with a     cumulative dose of 35% lower than in the RIST design. 33% had disease regression with 8% CR     or PR. A phase II study in rNB also using irinotecan and temozolomide with a substantially     lower intensity showed a response rate of 15%.      The combination of a mTOR inhibitor with a multi-kinase inhibitor demonstrated in preclinical     studies a synergistic effect on cell cycle arrest, apoptosis and sensitization for radio- and     chemotherapy. It is assumed that this combination of molecular targeted drugs with a     tolerable conventional chemotherapy consisting of irinotecan and temozolomide can     substantially improve the outcome of this patient population. A group of 20 rNB patients     treated with the RIST therapy approach in a compassionate use setting showed an overall     survival of 55% at a median of 80 weeks with a tolerable adverse event profile.   "
138798|NCT01467973|"     The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a     multinational , multicentre, prospective, observational, hospital-based registry of patients     with acute heart failure(AHF) with 3 month and one year follow-up.      Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure     particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable     medical practices and heart failure management setup in the Gulf region, AHF patients in the     Gulf states are expected to have different presentation and receive different management than     patients in European countries resulting in different outcome. It is also hypothesized that     there is considerable gap between heart failure management guidelines and clinical practices     in the Gulf region.   "
139478|NCT01459016|"     This study will investigate the volume, function and composition of the brain using magnetic     resonance imaging (MRI) and positron emission tomography (PET) scanning technology in     participants with memory complaints or early signs of Alzheimer's pathology.   "
138799|NCT01467960|"     In Italy affected people are 200,000 and every year Parkinson new cases are 10,000. Aging is     the principle risk factor of Parkinson with the possibility of its development doubling every     five years after 65. Because of the increase of the social longevity and aging as the main     risk factor, there are many repercussions on the health system (hospital stays and     pharmaceutical costs) as on the social system (assistance- related problems). Parkinson's     disease exerts an extremely negative impact on life's quality of the patient. In fact,     because of Parkinson symptoms (tremor, dribble, etc), patient's social life will be reduced     with the consequent development of the depression. Consequently, the early detection and     treatment of Parkinson's is necessary.      To achieve this goal, Apolipoprotein D (ApoD) in human serum as a marker of the oxidative     stress-inflammation vicious cycle seems most promising candidate for diagnosis.   "
138800|NCT01467947|"     This is a prospective, international, multi-center, non-randomized, single arm, open-label,     postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE     subjects treated intravenously with Berinert. Individual treatment duration per subject is 9     months, irrespective of the number of treated attacks. All subjects will receive 20 IU     Berinert/kg body weight per attack.   "
138801|NCT01467934|"     In this study, the investigators will prospectively assess fever rates and other associated     vaccine adverse events in 6-23 month old patients during days 0-7 after administration of     trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine     (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine     (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The     investigators hypothesize that fever rates will be significantly higher during the 0-1 days     after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal     conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered     non-concomitantly.   "
138802|NCT01467921|"     Oxaliplatin is a platinum analogue that has significant antitumor activity with better     tolerability than cisplatin. The objective of the study is to evaluate the safety and     activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin     combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive     esophageal cancer.   "
138803|NCT01467908|"     It has already been demonstrated that mental imagining of the complex motor act, such as limb     lifting, can evoke the activation of the involved motor centres even if it doesn't result in     movement due to paresis. Aim of the study: using the navigated brain stimulation system     create a new diagnostic model for the differential diagnostics between the vegetative state     and the minimally conscious state. If the investigators could get from patient the efferent     motor response after a verbal command, his level of conscious should not be defined less than     the minimally conscious state.   "
138804|NCT01467882|"     The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg     6-month formulation in 44 patients suffering from central precocious puberty. The total study     duration per patient will be 12 months (48 weeks).   "
138805|NCT01467869|"     Following spinal cord injury, most men are infertile and require medical assistance to father     children. The conditions that contribute to their infertility are erectile dysfunction,     ejaculatory dysfunction, and semen abnormalities. The Miami Project Male Fertility Program is     a research study designed to understand and improve impairments to male fertility resulting     from spinal cord injury.   "
138806|NCT01467856|"     Sleep-disordered breathing (SDB) occurs in 2% to 4% of the non-disabled adult population and     is characterized by periods of complete breathing cessation (apnea) or marked reductions in     airflow (hypopnea) during sleep. By contrast, the diagnosis of SDB affects as many as 83% of     persons with tetraplegia within one year of their injury. While some consider daytime     somnolescence from poor sleep quality a 'tolerable annoyance', SDB can decrease near-term     physical performance and mental alertness, decay memory and intellectual processing, invoke     mood disturbances, decrease healthrelated quality of life(HRQoL), and cause vehicular or     occupational injury. Recurrent sleep arousal is now strongly associated with cardiometabolic     (CM) component risks including insulin resistance, obesity, inflammatory stress, and     endothelial dysfunction. Despite considerable advancements in understanding and treating SDB     - including favored use of positive airway pressure (PAP) - an evidence base sufficient to     warrant routine evaluation and treatment of SDB and related sleep disorders remains elusive     for those with spinal cord injury (SCI). To address these knowledge and treatment     shortcomings the investigators will conduct a hypothesis-driven study with specific aims that     will: 1) describe by stakeholder survey the clinically-relevant determinants of sleep quality     in persons with chronic tetraplegia, 2) assess clinical features and co-morbid risks     associated with SDB in persons with tetraplegia, and 3) determine in persons with tetraplegia     having SDB whether treatment using PAP reduces health risks and improves HRQoL. Hypothesis 1     will be tested using data derived from a website survey.   "
138807|NCT01467843|"     Although national expenditures on back pain treatments have increased substantially over the     past decade, the health and functional status of persons suffering from back pain has     deteriorated. This trial will evaluate the effectiveness, and cost-effectiveness, of a safe     and relatively inexpensive mind-body therapy that has the potential to provide relief to     some of the millions of Americans who continue to suffer from chronic back pain.   "
138808|NCT01467830|"     The purpose of this study is to determine the efficacy of mesh fixation using absorbable     versus non-absorbable sutures.   "
138809|NCT01467817|"     The purpose of this study is to determine how exercise and nutritional guidance and     supplementation affects your physical fitness, risk for heart disease, your body's ability to     burn fat, and your opinions about your health.   "
138828|NCT01467570|"     It is generally recommended that oral rehydration should be used as first-line therapy to     treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink     regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended     treatment.      The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a     new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN     in children with acute gastroenteritis (AGE).   "
138829|NCT01467557|"     This study is an observational registry of patients who have recently been prescribed 1•DAY     ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.   "
138810|NCT01467804|"     This is a randomized, double-blind multi centric clinic study. Both of therapist and patient     are blind. There are 180 patients from 3 hospitals included, who meet DSM-IV criteria for     major depressive disorder, the score of HAMD-item＞20，＜35；and meet the criteria for TCM     syndrome of Liver Qi stagnation and Transformation of Stagnant Qi into Fire. Patients are     randomized to JWXY and sertraline treatment groups, receiving oral sertraline (start with 50     mg/day for one week then continue with 50 mg/day) plus placebo of JWXYJN; or oral JWXYJN plus     placebo of sertraline daily for 2 months. The symptoms of depression and anxiety are measured     with HAMD and HAMA tests at baseline and at 2，4，8 weeks; and LFT, BUN, Cr are assessed at     baseline and end of program. Then data will be analyzed with SPSS software to determine the     efficacy and safety of JWXYJN comparing to sertraline in the treatment of mild to moderate     major depressive disorder.   "
138811|NCT01467791|"     Registry to follow patients with sarcoidosis associated pulmonary hypertension   "
138812|NCT01467778|"     This is a Phase I study to assess the safety of three formulations of the dermal implant     ELAPR.   "
138813|NCT01467765|"     In patients with percutaneous endoscopic gastrostomy (PEG) delayed gastric emptying has been     speculated as a cause of aspiration pneumonia. Elemental diet may facilitate gastric emptying     in PEG patients as compared with regular liquid enteral nutrients, resulting in the     prevention of aspiration pneumonia.   "
138814|NCT01467752|"     Traumatic cartilage loss of the joint is central to the development of joint failure in     arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal     joint defects.   "
138815|NCT01467739|"     The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for     tracheal intubation in difficult airways due to cervical immobilization by a cervical collar,     and compare it to a conventional reusable fiberscope.   "
138816|NCT01467726|"     This is a Phase 1, Randomized, Placebo−Controlled, Double−Blind, Study of Safety,     Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.   "
138817|NCT01467713|"     The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly     before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in     adult patients.   "
138818|NCT01467700|"     The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily     (QD), sublingual (SL), in adult participants with acute depressive episodes associated with     Bipolar I disorder.   "
138819|NCT01467687|"     The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil     extended release capsules.   "
138820|NCT01467674|"     The aim of this study was to investigate the impact of glycemic control on clinical     periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced     glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood     samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP).   "
138822|NCT01467648|"     This is prospective and randomized study to assess the pharmacodynamics (t>MIC) of 0.5 g     every 8 h of doripenem in patients with VAP following administration by a 4 h infusion or 1 h     infusion.      Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE     II score, BUN, Cr, Blood culture will be collected.      Twelve patients will be enrolled in this study. After completion of the doripenem therapy for     3 days in this study, all patients will receive other sensitive antibiotics to eradicate     their bacterial infections.      Doripenem pharmacokinetic study will be carried out during the doripenem therapy. Blood     samples (approximately 2 ml) in group  0.5 g of doripenem with 4 h infusion every 8 h     regimen will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4,     4.5, 5, 6, 7 and 8 h after 7th dose of doripenem.      Blood samples (approximately 2 ml) in group  0.5 g of doripenem with 1 h infusion every 8 h     regimen will be obtained by direct venepuncture at the following time: 1, 1.5, 2, 4, 5, 6, 7     and 8 h after 7th dose of doripenem.      The doripenem assays by method of Ikeda K et al. (J Chromatogr B, 2008) will be performed.      Concentration of doripenem in plasma will be simulated in Monte Carlo technique (Computer     model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment)     and %CFR (Cumulative Faction Response)   "
138823|NCT01467635|"     A prospective diagnostic clinical study randomising patients undergoing endobronchial     ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and     hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps     (EBUS-TBNB).      The study aims to establish whether the use of EBUS-TBNB can significantly increase the     diagnostic yield over EBUS-TBNA, without an increase in complication rates.   "
138824|NCT01467622|"     The effect of local chest-tube management protocols on the duration of chest-tube therapy     following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units.     The primary study objective was the duration of chest tube therapy in postoperative patients.   "
138825|NCT01467609|"     Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The     aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate     patients with ulcerative colitis and reach high consistency to conventional colonoscopy.   "
138826|NCT01467596|"     The aim of this study is to determine the minimum effective volume of local anesthetic (50:50     mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for     surgical anesthesia in 50% of patients and to calculate the effective volume required to     produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (>65 years) and     in middle aged group (<45years) of patients.   "
138827|NCT01467583|"     The primary objective of this study is to determine whether a dose-adjusted prophylaxis     fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours     (hr) in patients with renal failure achieves peak and trough levels similar to patients with     normal renal function, and protects patients from developing venous thromboembolism (VTE).     Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing     interval from q24 to q48 hr, in patients with estimated creatinine clearance of < 30 ml/min,     will be safe and effective.   "
138870|NCT01467024|"     The purpose of this study is:        1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.        2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive          population.   "
138830|NCT01467544|"     Tai chi intervention may lead to relaxation and could potentially reduce the risk of     cardiovascular disease. This project entails a comprehensive and innovative approach for     understanding, measuring, and potentially reducing cardiovascular risk in women. The goal of     this area of research is to reduce cardiovascular risk and perhaps reduce illness and death.   "
138831|NCT01467531|"     This will be a single-center, two-cohort, three-period study in healthy adult subjects.     Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14     evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide     data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to     the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after     the last dose of study drug. There will be a washout period between Period 1 and Period 2 but     no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last     day in Period 2. The study will be conducted on an out-patient basis except for days where     serial pharmacokinetic sampling and safety assessments are scheduled.   "
138832|NCT01467518|"     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3     clinical development for the treatment of HIV infection. As HIV-infected subjects may also be     receiving methadone for opioid dependence, an evaluation of the potential interaction between     DTG and methadone is warranted. The primary objective of this study is to determine whether     concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone. As a     secondary endpoint, the PK of DTG will be compared to historical data. This study will be     open-label with subjects receiving DTG and stable doses of methadone. The study will be     conducted at one center in Canada in adult male and female subjects.   "
138833|NCT01467505|"     To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and     ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen     following liver transplantation.   "
138834|NCT01467492|"     The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination     with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in     treatment-experienced Black/African American and non-Black/African American participants with     Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a     prior course of interferon-based therapy.   "
138900|NCT01466634|"     Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain.     Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in     obstructive coronary artery disease.   "
138835|NCT01467479|"     The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C     Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a     (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic     acid (HCV RNA) 12 weeks after the last planned dose of study drug.   "
138836|NCT01467466|"     The purpose of this research study is to compare the effectiveness of intravenous isotonic     sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine with     oral placebo for the prevention of serious adverse outcomes following angiographic procedures     in high-risk patients.   "
138837|NCT01467453|"     The study objective is to investigate the clinical applicability of continuous IOP     measurement using TS with radio transmission over 24 hours.        -  Trial with medical device   "
138838|NCT01467440|"     Retrospective analysis of efficacy of selective laser trabeculoplasty in patients under     treatment with topical prostaglandins compared to patients without topical prostaglandins is     performed.      Inclusion criterion are patients with glaucoma or ocular hypertension, who underwent     treatment with selective laser trabeculoplasty due to insufficient control of intraocular     pressure during their routine treatment at the University Hospital Zurich / Division of     Ophthalmology.   "
138839|NCT01467427|"     This trial is conducted in Asia, Europe and North America. The aim of the trial is to     evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body)     of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with     Haemophilia B.   "
138840|NCT01467414|"     This trial is conducted in Europe. The aim of this clinical trial is to investigate the     pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250     (insulin degludec) in Japanese subjects with type 2 diabetes.   "
138841|NCT01467401|"     This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and     safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard®     30) in subjects with type 2 diabetes.   "
138842|NCT01467388|"     Retrospective analysis of efficacy of selective laser trabeculoplasty in pseudophakic     patients compared to phakic patients is performed.      Inclusion criterion are patients with glaucoma or ocular hypertension who underwent treatment     with selective laser trabeculoplasty due to insufficient control of intraocular pressure     during their routine treatment at the University Hospital Zurich / Division of Ophthalmology.   "
138843|NCT01467375|"     This trial is conducted in Oceania and North America. The aim of this trial is to assess the     long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes     who have completed the BIAsp-1234 trial.   "
138844|NCT01467362|"     Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local,     immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are     dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is     associated with skin barrier dysfunction that facilitates an easier allergen penetration into     the skin with an increased irritation and subsequent cutaneous inflammation. A lack of     important stratum corneum intercellular lipids and an inadequate ratio between compounds     enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy     usually twice daily improves dryness and subsequently pruritus during the treatment of atopic     dermatitis and especially improves the barrier function. Emollients make part of basic     therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and     Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration,     measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.      The primary objective of this study is to demonstrate the efficacy of the tested product     (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient     formula during 28 days.   "
138845|NCT01467349|"     This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as     part of an optimized therapy in a clinical setting.      Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the     date of discontinuation of the considered regimen or the date of last visit or the date of     lost to follow-up, whichever came first.      The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing     regimens in a urban clinic setting.   "
138846|NCT01467336|"     Through a prospective randomized study the aims of this study is to analyze the impact of 3     types of rehabilitation protocols on the Optimization of the post-operative clinical and     anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2     supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group):        -  strict immobilization for 6 weeks then active rehabilitation,        -  or 3 weeks of immobilization then 3 weeks of passive motion before active          rehabilitation,        -  or immediate passive motion for 6 weeks and then active rehabilitation.      Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an     arthro-CT will be performed at 1 year.      The investigators will evaluate: constant score and rate of tendon healing.   "
138847|NCT01467323|"     This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and     safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.   "
138848|NCT01467310|"     Research into treatments for breast cancer relies more and more on an understanding of how     the cells of tumor tissue act when they are exposed to a new or different drug. To find these     new or different drugs to treat cancer, researchers are looking at proteins that help cancer     cells grow, such as a group of proteins called Kinases. In this study the investigators want     to look at the activity of kinases when a particular experimental drug called GSK1120212 is     administered. GSK1120212 blocks a kinase called MEK. GSK1120212 is not yet approved by the     FDA for use in breast cancer patients. The investigators want to give subjects GSK1120212 for     a short period of time (one week) to see how MEK and the other kinases function in cancer     cells both before and after the study drug is given. This study is not intended to treat     cancer, it is looking at ways that the investigators may treat cancer in the future.   "
138877|NCT01466933|"     Children of mothers in the intervention parenting program are expected to show benefits over     the standard care control group in terms of better cognitive/language development, less     recent illness, and better height for age. The mothers assigned to the intervention parenting     program are expected to evidence higher levels of home stimulation, better health prevention,     and better dietary diversity, along with more accurate knowledge of child development.   "
138849|NCT01467297|"     40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be     enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be     compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days.     Primary objective of the study is to evaluate the effects of the treatment on serum     inflammatory biomarkers and the secondary objective is to evaluate the clinical and     microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment).      The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4);     Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy     assessment, Day 28-30).      The primary parameter to test the efficacy of the study medications will be the assessment of     the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10%     will be taken into account. The comparison between treatments will be performed at visit 2     and 3.   "
138850|NCT01467284|"     The proposed site-level randomized trial will test the effectiveness of a work site     intervention based on an ecological framework at preventing weight gain among high school     employees in Massachusetts. The investigators hypothesis is that the intervention will     positively impact healthy dietary patterns and physical activity, perceived organizational     commitment, coworker influences, social support, self-efficacy, and self-control, which in     turn will positively mediate or moderate the positive associations between the intervention     and the primary outcomes (change in weight, BMI, and waist circumference). If effective, the     intervention is designed to be generalizable to high school settings across the country and     has the potential to reduce the morbidity, mortality and economic costs of overweight and     obesity in this important population.   "
138851|NCT01467271|"     The main purpose of this study is to prospectively estimate the incidence of NSF in patients     with moderate to severe renal impairment after administration of DOTAREM®   "
138852|NCT01467258|"     Amantadine appears to be a specific substrate for acetylation by spermidine/spermine     N1-acetyltransferase (SSAT). SSAT activity in cancer cells is higher by several-fold compared     to normal cells. Amantadine can be used to determine SSAT cellular activity, and may indicate     the presence of cancer.      This study will provide additional information in conjunction with data from a previous study     which include cancer patients and normal health age matched controls to determine whether     urinary excretion of acetylamantadine is predictive for the presence of cancer, and if so     whether excretion of this metabolite is associated with any particular site of the tumor.     Based on the results of the first study additional data in normal healthy volunteers is     required.      The data from both studies will be analyzed to account for subject gender, stage of disease     at time of testing, concurrent diseases, alcohol and tobacco use and occupational     characteristics. This is an important first step in validating a cancer detection method that     can be implemented economically for screening of large numbers of people at sites remote from     limited and expensive diagnostic instrumentation. Thus there is a possibility that this     design can be prognosis biomarker as well as a positive/negative indicator.   "
138853|NCT01467245|"     This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for     repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic     hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the     thoracic cavity and may therefore cause hypercapnia and acidosis.   "
138854|NCT01467232|"     Following myocardial infarct, cellular therapy is a potential approach to repopulate the     injured myocardium, to treat heart failure and restore cardiac function. The purpose of this     study is to assess the safety, feasibility and efficacy of intramyocardial delivery of     selected autologous CD133+ bone marrow stem cells at the time of coronary artery bypass     grafting in patients with chronic ischemic cardiomyopathy.   "
138855|NCT01467219|"     The surgical management of high-risk endometrial cancer often involves an extensive operation     to remove lymph nodes as sites of possible cancer spread.      18F-FDG PET/CT imaging is increasingly being used to identify sites of cancer spread and     recently groups have used an intra-operative gamma probe to better localize metastatic     disease. In this pilot study, patients with newly diagnosed early stage, high-risk     endometrial cancer undergoing primary surgery will have a pre-operative PET scan and     intra-operative localization of metastatic lymph nodes with the use of a gamma probe. A     complete lymphadenectomy will follow and ability to detect positive lymph nodes of both PET     scan and the intra-operative probe will be calculated.      This study addresses the feasibility of an FDG detection gamma probe in addition to a     pre-operative PET/CT for lymphatic mapping in women with clinical early stage high risk     endometrial cancer. The study will also evaluate the role of identifying metastatic lymph     nodes intraoperatively that would otherwise be clinically negative.   "
138856|NCT01467206|"     The LAST study is a Norwegian multi site randomised controlled trial that intends to assess     the effect of a long term follow up program after stroke. The program consists of a     coordinating physiotherapist who will encourage and motivate included patients to perform at     least 60 minutes of intensive motor training every week and 30 minutes of physical activity     every day for 18 months after inclusion. The primary hypothesis is that patients receiving a     long term follow up program after stroke will have better motor function at end of follow up     than patients receiving standard care. A total of 390 home dwelling stroke patients living in     the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at     St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will     be randomised to an intervention group receiving the long term follow up program or to a     control group receiving standard care. Motor function, mental health and physical functioning     in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by     the Norwegian Research Council, the Norwegian University of Science and Technology and the     Central Norway Regional Health Authority and will conclude at the end of 2015.   "
138878|NCT01466920|"     The goal of this research is to fill the knowledge gap relating to why up to 20 percent of     total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to     answer the research question: What are the drivers of variation in the patient experience     with primary (ie. not revision) TKA?   "
138879|NCT01466907|"     The aim of this study was to examine to what extent a one year population of stroke patients     at a university hospital had well regulated risk factors and health problems one year after     stroke, and if a structured nurse-led previous follow-up in the intervention group including     referrals if needed could influence health outcome and risk factors one year after stroke.   "
138857|NCT01467193|"     This study aims at assessing the effect of standardized dietary fat load and short-term     aerobic exercise on systemic lipolysis, flexibility and partitioning of ectopic fat stores     (intramyocellular = IMCL, intrahepatocellular = IHCL, intramyocardial lipids = IMCaL) in     relation to FFA in endurance trained athletes and hypopituitary patients compared to     sedentary healthy control subjects.      Exercise is a powerful stimulation for growth hormone (GH) secretion in health. A     standardised exercise test can, therefore, be discriminative for the diagnosis of     GH-deficiency in adults. This will be assessed.      Hypothesis (ectopic fat stores)        1. Ectopic fats stores are flexible fuel stores and are influenced by diet and physical          activity.FFA availability may play an important regulatory role.        2. There is a tissue specific partitioning of triglycerides and/or FFA among non-adipose          organs after fat load and physical exercise        3. The flexibility of ectopic fat stores is related to insulin sensitivity        4. Lipolytic and anti-lipolytic hormones are critical for regulating FFA availability (at          rest or during exercise) and therefore also for the regulation of ectopic fat stores.        5. GH is a lipolytica hormone. Lack of GH in adulthood is related to decreased FFA          availability thereby influencing ectopic lipid stores Hypothesis diagnosis of GHD        6. A short intensive physical exercise shows a good discriminative power to diagnose GHD.   "
138858|NCT01467180|"     A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not     efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off     dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of     Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.   "
138859|NCT01467167|"     Recently, a new software program for anesthesia has been developed, called Smart Pilot View.     This program monitors the patient, the anesthetic drugs given, and the calculated depth of     the anesthesia. The purpose of this study is to determine whether the use of this program     improves the quality of anesthesia.   "
138860|NCT01467154|"     The aim of the present study is to determine whether a high dose of intravenous NAC is     efficient in preventing CN after emergency contrast injection in patients with renal failure.   "
138861|NCT01467141|"     This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy     in children with type 1 diabetes.   "
138862|NCT01467128|"     The next four decades will see a marked expansion of the elderly population in Ireland, in     particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of     prescription medicines in Ireland and have the highest prevalence rates of major     polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and     consequent major morbidity and mortality. Epidemiological data from the Unites States     indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that     effective evidence based interventions can be applied to this major public health problem.      A recently described approach to hospitalised older patients' medication optimisation is that     of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with     expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients     from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for     older patients and their carers where appropriate as well as feedback information to     prescribers in the event of detecting instances of probable medication inappropriateness.     Whenever an opportunity for medication optimisation is identified, the pharmacist discusses     the opportunity with the prescriber who can accept or reject the intervention. At discharge     from hospital, the pharmacist also provides written and verbal information on treatment     changes to the patient / caregiver and GP. The intervention therefore represents a     comprehensive pharmaceutical care approach that is based upon careful review and subsequent     consensus on individualised pharmacotherapy. In an RCT comparison of this approach with     standard care, older patients in the intervention arm of the study had significant     improvements in medication appropriateness (medication appropriateness index (MAI), Beers'     criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist     review of older peoples' medication in hospital is a proven intervention in term of reducing     inappropriateness of medication.   "
138921|NCT01466361|"     This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a     cigarette compared to a matched placebo (a placebo is like sugar pill and contains no     active).   "
138863|NCT01467115|"     More than 50% of Head and Neck cancers are locally advanced at presentation. Although     surgery, in combination with other modalities like radiation therapy can achieve 40-50% five     year survival rates, resection in the head and neck region can leave patients with poor     functional and cosmetic outcomes.      Due to these concerns about quality of life after surgery, there has been a lot of interest     in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy     and biologics has showed promising results. However, questions still remain about the ideal     combination treatment regimen.      Based on assimilation of data from multiple sources, our study tries to identify the role of     a potentially highly effective multi-modality regimen based on induction chemotherapy     (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent,     Cetuximab, and radiation therapy.   "
138864|NCT01467102|"     This project a European observational study on the incidence and characteristics of chronic     post surgical pain (CPSP).      Research Questions        -  What is the incidence of chronic post surgical pain (CPSP) in Europe?        -  What are the risk factors of chronic post surgical pain (CPSP) related to surgery,          patient and anaesthesia management?        -  What are the difference in incidence and risk factors in different European countries?   "
138865|NCT01467089|"     The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS)     and tardive dyskinesia (TD) examinations conducted via live two-way video versus live     examinations completed in-person   "
138866|NCT01467076|"     This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in     Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume     sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate     the feasibility and safety of prolonged IPGE1 administration and determination of optimal     dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over     a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of     IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale     randomized controlled trial will be planned.   "
138880|NCT01466894|"     This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection,     multiple dose administration study comprising three groups, with up to 40 patients in each     active treatment and placebo group. Patients with biopsy proven nonalcoholic steatohepatitis     (NASH) and elevated liver enzymes will be randomized to undergo a liver MRI scan and to     receive Imm 124-E or placebo for 24 weeks. During this period, patients will be followed for     clinical and laboratory effects. At the end of 24 weeks of treatment, patients will undergo a     second liver MRI scan. Patients will be followed for an additional 4 weeks for safety after     completion of treatment.   "
138944|NCT01466062|"     To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24     months or less with immunocompromised medical conditions.   "
138867|NCT01467063|"     Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile     (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to     become less sensitive to insulin, particularly during adolescence.      The overall objective of this project is to gain further insight into the possible benefits     of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin     sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators     will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an     IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely     measured amounts of glucose by vein: the amount of glucose required to prevent a drop in     blood sugar reflects the body's sensitivity to insulin. The investigators will also give an     IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive     isotopes to better understand how glutamine may work. This procedure will be performed in 2     groups of 10 adolescents in the morning either after a strenuous exercise performed the     previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject     will be studied twice, once after taking oral GLN, once after placebo, in separate clinical     research center (CRC) admissions a few weeks apart, in random order.      Should the investigators hypothesis prove to be true, it would warrant long term studies to     determine whether sustained dietary GLN supplementation can decrease insulin requirements and     ultimately improve diabetes control in teenagers with T1DM, If successful, this approach     could potentially have a significant positive impact in terms of adolescent health.   "
138868|NCT01467050|"     The next four decades will see a marked expansion of the elderly population in Ireland, in     particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of     prescription medicines in Ireland and have the highest prevalence rates of major     polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and     consequent major morbidity and mortality. Epidemiological data from the United States     indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that     effective evidence based interventions can be applied to this major public health problem.      Recent research data indicate a cause-and-effect relationship between inappropriate     prescription medicines and serious ADEs in older people in hospital. To date, Beers' criteria     have been the dominant set of criteria for defining potentially inappropriate medicines     (PIMs) in late life. Research data collected by this group show that the recently validated     STOPP/START criteria (Screening Tool of Older Persons' Prescriptions and Screening Tool to     Alert doctors to Right Treatment) identify ADEs that are causal or contributory to acute     hospital admission in older people 2.7 times more frequently than Beers' criteria. Based on     these findings, our hypothesis is that STOPP/START criteria have the potential to be used as     a regular intervention for the purpose of ADE prevention in older people. A recent single     centre randomised control trial (RCT) undertaken at Cork University Hospital showed that     prospective application of STOPP/START criteria led to a highly significant improvement in     medication appropriateness in older hospitalised patients compared with standard inpatient     pharmaceutical care. Significantly, the improvement in medication appropriateness was     maintained to the end of the study follow-up i.e. 6 months post-discharge. However, the     ability of STOPP/START criteria to significantly reduce ADEs in a prospective RCT has yet to     be demonstrated.   "
138869|NCT01467037|"     Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The     cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would     amount to 13,600 Canadian children < 5 years. The incidence of nosocomial RV infections is an     average of 8/10,000 patient-days in children < 5 years. An immunization program with a     live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented,     free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait     of the disease and give critical information to the public health agencies as they struggle     to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases     with similar characteristics; estimate selection bias in passive laboratory-based     surveillance; and estimate the agreement between surveillance time-series created from     passive and active surveillance data sources.   "
138871|NCT01467011|"     The purpose of this study is to gather information regarding the use of Myfortic, Prograf,     and corticosteroids in new liver transplant recipients. These three medicines help to prevent     the body from rejecting the transplanted liver. The information the investigators are     obtaining is data relating to the process of Myfortic absorption by the body, its     distribution in the body, the breakdown of Myfortic in the body, and its elimination from the     body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.   "
138872|NCT01466998|"     Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe     enough to require treatment in 20%. Although postmenopausal hormone therapy is effective in     suppressing hot flashes, it is associated with increased risk for a variety of serious     adverse effects. There is an urgent need for alternative treatments that are effective, safe,     and easy to use. In this study, the investigators will compare two different types of     behavioral relaxation therapies, paced respiration and music therapy, for treatment of     menopausal hot flashes. Effects on frequency of hot flashes, other symptom and     quality-of-life outcomes associated with hot flashes, and physiologic measures of     sympathetic/parasympathetic activity will be examined.   "
138873|NCT01466985|"     This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral     activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve,     HIV-1-infected participants.   "
138874|NCT01466972|"     The purpose of this study is to evaluate the clinical benefit rate at 12 weeks from the     addition of pazopanib to a non-steroidal aromatase inhibitor (NSAI) (letrozole or     anastrozole) in patients with hormone receptor positive advanced breast cancer progressing on     the same NSAI hormone therapy.   "
138875|NCT01466959|"     An alternative to systemic heparin anticoagulation for HD is citrate dialysate (CD). CD     contains a small amount of citric acid rather than acetic acid as the acidifying agent. The     use of citrasate may lead to lower heparin requirements in hemodialysis. This is a     randomized, double blinded, two-period crossover trial in HD patients to compare the effect     of citrasate dialysis (CD) and usual acetic-acid based dialysate (AD) on heparin dose.   "
138876|NCT01466946|"     The purpose of the study is to understand why Hispanic/Latino patients with lung cancer are     diagnosed later than other groups.   "
138881|NCT01466881|"     This phase II trial studies how well alisertib works in treating patients with peripheral     T-cell non-Hodgkin lymphoma that has come back after a period of improvement or has not     responded to treatment. Alisertib may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth.   "
138883|NCT01466855|"     This study will test if giving topotecan directly into the blood vessel of the eye will     improve the treatment of retinoblastoma. This method is referred to as selective     intra-ophthalmic artery chemotherapy (SIOAC).      The goals of this study are:        -  To find out if topotecan is an effective treatment for retinoblastoma when delivered          directly to the ophthalmic artery (SIOAC delivery)        -  To find out what kind of effects (good and bad) can be expected when topotecan is given          by SIOAC        -  To assess visual pathway function before and after the study therapy        -  To learn more about the pharmacology (how your body handles the drug) of topotecan when          delivered directly to the ophthalmic artery   "
138884|NCT01466842|"     The purpose of this study is to determine whether catheter ablation is more effective than     antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the     patients a subcutaneous loop recorder will be implanted.   "
138885|NCT01466829|"     The aims of this study is to compare healing time and quality of newly formed bone in cardiac     surgery patients treated with PTH post-surgically and a control group treated with saline.   "
138886|NCT01466816|"     Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in     unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle     towards less accumulation of lipid metabolites and an improved insulin sensitivity.      Objective:        1. The contribution of dietary vs endogenous fat sources to lipid overflow in the          circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant          subjects vs obese insulin sensitive controls.        2. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs          polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and          storage, fatty acid mediated gene expression and postprandial insulin sensitivity in          obese insulin resistant subjects.      Study design: single-blind randomized cross-over trial      Study population: obese males (35-70 years) with or without insulin resistance      Intervention:        1. 1 test meal        2. 3 test meals with a different fatty acid composition      Main study parameters/endpoints:      More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle     fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an     increased insulin sensitivity.   "
138887|NCT01466803|"     Variability in drug response can be due to either pharmacokinetic or pharmacodynamic factors.     The reasons why people differ in pharmacokinetics or pharmacodynamics are manifold and     include, e.g., genetic factors, diseases, age and concomitantly administered drugs. Oxidation     reactions are dominant in the metabolism of drugs and cytochrome P-450 enzymes (CYP) have     been recognized as chief contributors (Guengerich 1992). We have previously shown that drug     interactions mediated by the inhibition of CYP enzymes may be of major clinical significance     (Olkkola et al. 1993; Olkkola et al. 1994; Varhe et al. 1994; Olkkola et al. 1999; Palkama et     al. 1999; Jokinen et al. 2000).      Buprenorphine undergoes extensive first-pass metabolism and has low oral bioavailability of     15 % (Cone et al. 1984). Bioavailability following sublingual administration of buprenorphine     is higher, 50-60 % (Nath et al. 1999). After high sublingual doses of buprenorphine (8-24     mg), peak plasma concentrations are reached in 1 hour (McAleer et al. 2003, Ciraulo et al.     2006) and after low sublingual doses (0.4 mg) they are reached in approximately 3 h     (Billingham 1981). Approximately two-thirds of a buprenorphine dose is excreted unchanged,     and the rest is metabolized in the liver and intestinal wall. N-dealkylation of buprenorphine     mainly via CYP3A but also CYP2C8 yields norbuprenorphine, and glucuronidation yields     buprenorphine-3-glucuronide (Cone et al. 984). Norbuprenorphine is excreted in the urine     after subsequent conjugation. 80-90 % of buprenorphine is excreted by the biliary system and     enterohepatic circulation (Brewster et al. 1984)      Although few interaction studies of high-dose buprenorphine and antiretrovirals have been     conducted (McCance-Katz EF et al. 2007), the effect of CYP3A inhibitors on the     pharmacokinetics of low-dose buprenorphine is unknown. Because the use of buprenorphine in     pain management is increasing after the introduction of transdermal buprenorphin patches to     the market, it is clinically relevant to study and quantify possible interactions of     buprenorphine with inhibitors of its CYP3A-mediated metabolism such as voriconazole.      This study is aimed to examine the possible interactions of oral buprenorphine with     voriconazole.      Twelve male or female adult non-smoking subjects aged 18-40 years with body weights within     ±15% of the ideal weight for height will be recruited for the study. The subjects will be     submitted to physical examination, determination of previous or present chronic diseases, and     comprehensive laboratory testing to ascertain that they are in good health. The subjects will     fill in a modified Finnish version of the Abuse Questions (Michna et al. 2004) to assess     their vulnerability for opioid abuse. Laboratory screening will include CBC (including     hemoglobin, hematocrit, differential WBC, platelet count), SGOT, SGPT, alkaline phosphatase,     BUN and creatinine, and for women a pregnancy test. Urine will be screened for glucose,     proteins and drugs with addiction potential. Blood pressure in sitting position must be     within normal limits. Base line ECG must be normal.      Placebo and voriconazole should always be ingested with food, except the first dose on day 5.      On day 5, the challenge dose of 0.2 or 3.6. mg of oral buprenorphine (Temgesic,     Schering-Plough) will be administered at 11.00, i.e. 1 h after the last dose of placebo or     voriconazole. The dose is 3.6 mg after placebo and 0.2 mg after voriconazole. If necessary,     naloxone (Naloxone B. Braun, Braun) will be given in sufficient doses to counteract the     severe adverse effects of buprenorphine. For nausea and vomiting, intravenous tropisetron     will used, if needed.      The volunteers will fast at least 8 h before the administration of buprenorphine and they     will have a standard meal 4 h and 8 h afterwards. Ingestion of alcohol, coffee, tea, cola,     energydrinks and grapefruit juice is not allowed during the test days, nor is smoking     permitted.      The interval between the study phases will be four weeks.   "
138888|NCT01466790|"     The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977     (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1     hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or     are HCV treatment-naive (patients who never received treatment for HCV infection).   "
138889|NCT01466777|"     The aim of this study is to compare the robotic-assisted laparoscopic surgery to the     traditional laparoscopic surgery in endometrial cancer patients.      The study is prospective and the patients are randomised into two groups of 50 patients each.     Randomisation is done with Minim-programme and patients age and Body mass index are taken     into account.      The primary endpoint is the operation time. The number of patients in this study is based on     the non-inferiority design. Presumption is that the operation time in robotic-assisted     laparoscopy will be 25% longer.      Secondary endpoints include:        1. bleeding        2. complications        3. conversions        4. number of pelvic lymph nodes   "
138890|NCT01466764|"     The investigators hypothesize that perioperative administration of anakinra will reduce     incisional pain by lowering the concentration of inflammatory mediators in surgical wounds.     This knowledge is important because it suggests a new, previously unexplored pharmacological     target for the control of postoperative incisional pain.   "
139479|NCT01459003|"     Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer   "
138891|NCT01466751|"     The present study will explore the effectiveness of a computer based neurobehavioral     intervention in alleviating symptoms and improving emotion regulation in psychiatric     populations. It will increase understanding of psychopathology at a neural-circuit level and     aid development of new non-pharmacological treatment for emotion regulatory deficits.   "
138892|NCT01466738|"     The purpose of this study is to evaluate the safety and clinical characteristics of a     quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16     will be subsequently used in viral challenge studies with new compounds that are intended to     treat respiratory diseases.   "
138893|NCT01466725|"     The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects     with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be     evaluated.   "
138894|NCT01466712|"     Inuvair® is a novel fixed combination product used in the treatment of asthma and under     clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is     able to target the whole bronchial tree, including the small airways and hence, is expected     to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its     action on the small airways is not directly demonstrated thus far. By way of contrast, dear     evidence is present that treatment with bronchodilators alone does not beneficially alter     small airway function. The study hypothesis states that the effects of inhaled     corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.   "
138895|NCT01466699|"     The purpose of this study is to investigate whether and what extent blood pressure     variability is associated with arterial stiffness and carotid atherosclerosis, furthermore to     compare the difference in the relationship of the types of blood pressure variability with     arterial stiffness and carotid atherosclerosis.   "
138896|NCT01466686|"     To evaluate the safety and effectiveness of low dose rate radiation therapy plus     temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic     Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery     followed by radiation surgical resection followed by adjuvant radiation therapy plus     temozolomide.   "
138897|NCT01466673|"     The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and     Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment     of female participants with mild to moderate acne vulgaris (pimples).   "
138898|NCT01466660|"     This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in     first-line treatment setting with patients who are having epidermal growth factor receptor     mutation positive advanced adenocarcinoma of the lung.   "
138901|NCT01466621|"     The present proposal is designed to investigate the response to CRT in patients who were     previously paced from the right ventricle (RV). The negative physiologic and structural     changes associated with chronic RV pacing are well documented, but patient response following     upgrade to CRT after chronic RV pacing has not been well characterized in a large cohort.   "
138902|NCT01466608|"     The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and     lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia     patients.   "
138903|NCT01466595|"     This study is being done to see whether rifaximin, an antibiotic that works in the     intestines, can lower the amount of germs in the intestines of HIV infected persons. It is     possible that when the amount of these germs is lowered, an HIV-infected person's immune     system will become less active and will have a better chance of recovering. Also, the study     will evaluate the safety of using rifaximin in HIV-infected subjects.   "
138904|NCT01466582|"     In this prospective cohort study the investigators will assess the prevalence and incidence     of a broad range of age-related co-morbidities and their (known) risk factor among     HIV-patients and HIV-negative controls. HIV might cause premature onset or accelerated aging     and could therefore result in an increase of age-related comorbidities when compared with     controls.   "
138905|NCT01466569|"     The purpose of this study is to determine the safety and tolerability profile including the     dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of     epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with     chemo-naive/chemo-refractory recurrent, locally advanced or metastatic gastric cancer.   "
138906|NCT01466556|"     The aim of this study is to determine the prevalence of metabolic syndrome amongst obese     children in our region with a body mass index (BMI) above the 95th percentile for age and     sex.   "
138907|NCT01466543|"     The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral     blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive     impairment subjects.   "
138908|NCT01466530|"     Misoprostol would reduce the uterine bleeding after caesarean delivery, without harmful     effects on either mother or baby. The investigators postulated that the use of sublingual     misoprostol during isoflurane anaesthesia for uncomplicated caesarean delivery would reduce     maternal haemorrhage, uterine atonic effects, and the need for additional uterotonic agents,     without harmful effects on either mother or baby. Therefore, the present study was designed     to evaluate the effects of preoperative sublingual misoprostol on maternal blood loss,     uterine tone, the need for additional oxytocin and neonatal outcome after elective caesarean     delivery under isoflurane anaesthesia.   "
138909|NCT01466517|"     A PHASE IV, OPEN LABEL, RANDOMIZED, TWO-WAY CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE     RELATIVE BIOAVAILABILITY OF IBUPIRAC 40MG/ML (LABORATÓRIOS PFIZER LTDA) ORAL SUSPENSION FORM     VERSUS ALIVIUM® 50MG/ML (MANTECORP INDÚSTRIA QUÍMICA E FARMACÊUTICA LTDA.) ORAL SUSPENSION     FORM, UNDER FASTED CONDITIONS IN HEALTHY VOLUNTEERS.   "
138922|NCT01466348|"     A reduction in alertness and lower levels of performance are commonly associated with the     common cold. Paracetamol has been shown to be more effective than placebo in treating     symptoms associated with upper respiratory tract infection; caffeine has been shown to     increase levels of alertness and improve performance of people suffering from colds. This     study will investigate any improvement in alertness and performance based on cognitive     function and mood assessment in subjects suffering from the common cold, when taking a novel     paracetamol and caffeine combination verses paracetamol alone.   "
139480|NCT01458990|"     The purpose of this study is to find out whether the use of medications that suppress acid in     your stomach can change the composition of your bowel bacteria.   "
138910|NCT01466504|"     Skin toxicity is a frequently observed side effect in the era of molecularly targeted     therapies. Skin toxicity following administration of protein kinase inhibitors such as     sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient,     resulting in dose reduction and discontinuation of treatment. The mechanisms of skin toxicity     induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly understood.     Further research is warranted to better understand the pathophysiology of drug-related skin     toxicity in this setting and develop correction strategies. This study tests the hypothesis     that sorafenib and regorafenib interfere with p63 expression and keratinocyte differentiation     and skin remodeling.      Eligible study participants will be evaluated clinically for evidence of skin toxicity during     their visits to the outpatient Oncology clinics. Study participants will undergo skin     biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12     weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in     Oncology clinics by the study investigators and clinic support staff.      Study participants will undergo both skin biopsies regardless of whether they develop a rash.     In patients who develop a rash the most representative lesion will be biopsied. A normal     appearing area of skin will be biopsied in participants who do not develop a rash.   "
138911|NCT01466491|"     The purpose of this study is to determine the level of pain women experience with a surgical     abortion and the effect that varying paracervical block techniques might have on that pain.     These different techniques involve wait time following the injection as well as the number of     sites injected.   "
138912|NCT01466478|"     The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus     calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus     calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using     the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.   "
138913|NCT01466465|"     Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced     allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is     limited by a long treatment time and high non-responder frequency. Based on experimental and     epidemiological evidences we hypothesize that vitamin D can act as an effective     immunomodulatory adjuvant to overcome these limitations.   "
138914|NCT01466452|"     This study is a randomized open label study that implies the administration of asprin     according to three different regimens.      The aims of the study are:        -  to establish whether coronary artery bypass surgery and / or aortic valve replacement          surgery with bioprostheses is associated with changes in the rate of platelet          regeneration that can reduce the effectiveness of aspirin administered at a dose of          100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.        -  to determine whether these patients need a different (shorter) interval of          administration in order to completely and permanently inhibit the platelet COX-1.      The endpoints of this study are:      - To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after     administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2     alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12     and 24 hours after administration of aspirin   "
138915|NCT01466439|"     The repetitive transcranial magnetic stimulation (rTMS) is a recent technique that has     demonstrated its efficiency in both depression and schizophrenia. However if its efficiency     has been recognized by the scientific community and the clinicians, its action on neurons and     cerebral networks remains debated.      In the motor regions, the different rTMS studies generally use frequencies of stimulation of     1 to 40 Hz with differential effects; the low frequencies being associated with an inhibitory     effect whereas highest frequencies have rather some facilitator effects as attested by the     motor responses. What is valid for the motor system is not however necessarily applicable to     other cerebral regions that have different neuronal organizations. If it is easy to observe     these opposite effects of rTMS on the motor system (presence or absence of movements), these     potential effects on more integrated cortex involved in high level functions have not been     proved.      One of the possibilities to interpret the effects of the rTMS in no-motor cerebral regions     would be to study the modifications of the EEG before and after rTMS and to see if a     differential effect of the high and low frequencies of stimulation exists. Up to now, the     studies having coupled these two techniques have observed modifications of the brain electric     activity only during some seconds to minutes after rTMS, what appears in contrast with the     clinical effects observed after a long delay (several days).      The contribution of our research resides in the use of the paradigm of suppression of P50     evoked potential component before and after rTMS tested with low and high frequencies of     stimulation. This paradigm consists in two identical auditory stimuli presented at a very     short interval (generally 500 milliseconds), the second sound generating a P50 wave of weaker     amplitude than the first or being completely abolished in healthy subjects. However, this     effect that has been well studied could result from an inhibitory action due to the gabaergic     interneurons on the pyramidal neurons of the cortex. Thus, the investigators hypothesize that     high frequency rTMS would have a facilitator effect on temporal lobe and so would induce no     suppression of the P50 after-rTMS whereas low frequency rTMS would induce an inhibitory     effect marked by a greater suppression of the P50.      Methods: 30 healthy subjects (of which 16 women) will be included after written consent. They     will receive after randomization 2 sessions of rTMS in cross over at 1Hz and 20Hz at 30 days     interval. An EEG and a P50 evoked potential will be done before and after rTMS. The site of     stimulation will be determined by neuronavigation and will correspond to the maximal     activation cluster generated by a language task during functional magnetic resonance imaging.     The main judgment criterion is the S2/S1 ratio of the P50. The potential secondary effects     will be evaluated (UKU adapted). The secondary criteria are the comparisons before and after     rTMS of EEG spectrums in the alpha, beta and gamma bands.   "
138916|NCT01466426|"     This pilot study aims at validating 18F-flourodeoxyglucose positron emission     tomography/computed tomography (FDG-PET/CT) in the detection and characterization of venous     thromboembolism (VTE) in the entire human body, especially deep venous thrombosis (DVT) and     pulmonary embolism (PE). On completion of this study the investigators will hopefully be able     to demonstrate the importance of functional/molecular imaging technique in managing patients     with this common and potentially fatal disorder.   "
138917|NCT01466413|"     This is an early phase study comparing two fixed dose of the study compound ELAPR and a     Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of     the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each     treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a     3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each     injection will consist of 20-30ul of product delivered using a 30Gx¼ needle.   "
138918|NCT01466400|"     It is hypothesized that there will be no difference in the breath hydrogen excretion between     the 2 different prebiotic formulas.   "
138919|NCT01466387|"     This study compares the safety and immunogenicity profile of several travel vaccines given     alone or concomitantly with MenACWY-CRM to healthy adults.   "
138920|NCT01466374|"     The purpose of this study is to determine whether BMS-936557 is effective for the treatment     of moderate to severely active Crohn's Disease in patients who have had insufficient response     and/or intolerance to conventional therapy for Crohn's Disease.   "
138923|NCT01466335|"     Ronacaleret is an orally administered CaSR antagonist which has previously been demonstrated     to transiently increase PTH in both animals and humans. Additional studies in post-menopausal     women and patients with distal radial fractures have demonstrated both anabolic and catabolic     effects on bone biomarkers and scans of bone density. Based on ronacalerets ability to     interact with the CaSR inducing PTH release and activating endogenous bone metabolism of both     osteoblasts and osteoclasts, it is our intention to evaluate the impact activation of this     pathway has on mobilization of Hematopoietic stem cell (HSCs) into the periphery.      This is an adaptive, phase I, randomized, single centre, double-blind dose finding,     parallel-group, multi-cohort placebo controlled study of the efficacy and safety of     ronacaleret in up to 45 healthy human volunteers. Cohorts of eligible subjects will be     studied for periods up to 28 days. Total daily doses of ronacaleret will range from 100mg, up     to 400mg and be administered for a maximum of 28days. The first part of this study will     evaluate several doses and schedules of ronacaleret, run in parallel, with respect to their     ability to affect mobilization of CD34+ cells into the peripheral circulation. In subsequent     cohorts of the study we will utilize information obtained from previous cohorts to further     refine and optimise those dosing paradigms which show efficacy. For the first cohort of study     participants; the study will commence with 6 days of dosing in an inpatient setting followed     by 21 days of continued dosing and evaluation as an outpatient, with a series of regularly     scheduled visits, with the final visit on day 28. The study period will include evaluations     of pharmacokinetic and pharmacodynamic parameters along with standard laboratory and safety     evaluations. The second cohort may be treated with ronacaleret for periods ranging from 14 to     28 days in order to optimise the treatment paradigm with respect to pharmacodynamic efficacy.     The PK/PD of each group in cohort one will be utilized to make adjustments in the total daily     dose, dose frequency and or duration of dosing investigated in cohort 2. Decisions will be     made as to dropping doses based on the PK/PD results and any safety considerations. An     initial equal randomization amongst groups within the first cohort may be adjusted to allow     for other randomization strategies as various doses and schedules are assessed.      The objective of this study is to characterise the dose-response curve for ronacaleret with     respect to safety and efficacy based on changes in peripheral CD34+ cell counts. Results     obtained from this study will inform us: of optimized doses, schedules, and durations of     treatment for future studies. Additional cohorts may be added to further explore the dose     schedule and duration if required. The exact number of cohorts studied will depend on the     results obtain from the prior groups and the desire to explore a variety of doses and     schedules. The aims of the present study (CR9115166) include an assessment of the     pharmacodynamic effects (mobilization of CD34+ cells), safety, tolerability, and     pharmacokinetics of ronacaleret in healthy human volunteers.   "
138924|NCT01466322|"     GSK2018682 is a potent and selective agonist for the sphingosine-1- phosphate receptor     subtype 1 (S1P1) with the potential to be an effective treatment for multiple sclerosis (MS).     The immunomodulatory properties of GSK2018682 are related to functional antagonism of S1P1 on     lymphocytes, resulting in sequestration of lymphocytes within the lymphoid organs, rendering     them incapable of migrating to sites of inflammation and leading to lymphopenia. Orally     administered GSK2018682 is very effective in murine experimental autoimmune encephalomyelitis     (EAE), an animal model of human MS. This study will assess the relative bioavailability of     different oral formulations of GSK2018682 in healthy volunteers. A tablet formulation is     desired for progression into future clinical safety and efficacy studies as the current     capsule formulation is not suited to large scale manufacture. The information obtained in     this study will help to establish the optimal dosing form for future studies, and also     determine the effect of food on the pharmacokinetics of GSK2018682.   "
138925|NCT01466309|"     Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been     reported its safety and efficacy in Caucasians at least in the short-term. However, there has     been no reports in Thai patients. The objectives of this study is to investigate its efficacy     and safety in Thai patients with OSA.   "
138926|NCT01466296|"     The overall objective is to improve the functional status of Middle East adolescents with     disabilities due to cerebral palsy (CP) and disabilities in adults due to cerebro-vascular     stroke (Hemiplegia) by a collaborative Jordanian-Israeli-Palestinian-Moroccan applied     research project.   "
138927|NCT01466283|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in patients with rhabdomyosarcoma.   "
138928|NCT01466270|"     RATIONALE: Donepezil hydrochloride may help lessen cognitive dysfunction caused by     chemotherapy.      PURPOSE: This phase II trial is studying donepezil hydrochloride in treating cognitive     dysfunction after chemotherapy in female breast cancer survivors.   "
138929|NCT01466257|"     RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will     respond to treatment.      PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.   "
138930|NCT01466244|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors predict how well patients will respond to treatment.      PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent     head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.   "
138931|NCT01466231|"     Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered     to the patient until progression, unacceptable toxicity, complete response or inability of     the subject to comply with study requirements. Feasibility of surgical resection will be     assessed after every 2 cycles of the treatment in patients with partial response.   "
138932|NCT01466218|"     This project will evaluate the effects of World Trade Center (WTC) exposure in WTC responders     10-13 years following the events of 9/11. Prior studies have described persistent pulmonary     function abnormalities in a significant portion of responders. The investigators study seeks     to examine the relationship between pulmonary function abnormalities and other markers of     chronic cardiopulmonary disease and further elucidate the pathophysiologic effects of     exposure to inhaled particulate matter (PM) on 9/11. This study will provide critical     information regarding risk of exposure to PM, risk factors for disease and potential for     improvements in diagnosis and treatment.   "
138933|NCT01466205|"     Currently, no study to date has directly tested a selective D1R agonist in relation to the     cognitive impairment of Schizophrenia without the confound of neuroleptics. The investigators     propose to examine the efficacy of DAR-0100A, a highly selective, full D1R agonist supported     by pre-clinical and preliminary pilot clinical data, in ameliorating the cognitive deficits     in Schizotypal Personality Disordered subjects receiving no medications including     antipsychotics.      The investigators hypothesize that 1) Baseline primary outcome measures will be impaired in     Schizotypal personality disorder (SPD) subjects compared to controls, 2) SPD subjects on     DAR-0100A will show improvement on primary measures greater than healthy controls and SPD     patients randomized to placebo, and 3) SPD patients will show significant improvements on     primary outcome variables on drug compared to placebo.   "
138934|NCT01466192|"     This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and     Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous     treatment.   "
138935|NCT01466179|"     The purpose of this study is to confirm whether the bispecific T cell engager antibody     blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or     refractory Acute Lymphoblastic Leukemia (ALL).   "
138936|NCT01466166|"     The primary purpose of this study is to observe patients being treated with KRYSTEXXA in a     standard healthcare setting in order to evaluate the frequency and severity of infusion     reactions, anaphylaxis and immune complex related events. Additionally, serious adverse     events associated with KRYSTEXXA therapy will be identified.   "
138937|NCT01466153|"     The overall purpose of the study was to determine if MEDI-551, when used in combination with     salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are     not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to     rituximab in the same population.   "
138938|NCT01466140|"     The primary objective of this study is to determine whether exploring the request for help     more thoroughly improves patient satisfaction in general practice (primary care).   "
138939|NCT01466127|"     The purpose of the study is to learn how differences in learning under mildly-stressful     circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the     body. The investigators will also examine the impact of any anxiety, depression, and stress     related symptoms on learning processes.   "
138940|NCT01466114|"     Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with     cognition. Currently, there are no FDA-approved treatments targeting cognitive function in     Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used     in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as     compared to treatment with a placebo pill in combination with standard anti-inflammatory     drugs in women with MS.   "
138941|NCT01466101|"     Pregabalin will decrease the total amount of opioid required in patients undergoing total     abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related     side effects in patients undergoing total abdominal hysterectomy.   "
138942|NCT01466088|"     Alzheimer's disease is the most common form of dementia and is the fourth leading cause of     death among people 65 years of age and older. The global prevalence of the disease will     increase significantly as the population ages, unless preventative treatments can be     identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an     approved medication (donepezil) shown to improve cognition and function in patients with     Alzheimer's disease.   "
138943|NCT01466075|"     The purpose of this study is to demonstrate that untrained subjects who have diabetes or     pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and     obtain valid glucose results.   "
138945|NCT01466049|"     The purpose of this study is to evaluate new biomarkers for patients presenting to a     physician for surgery to remove a mass in their pelvis and to continue to evaluate these     types of patients using the ROMA algorithm for post-market benefits.   "
138946|NCT01466036|"     Cabozantinib works by blocking the growth of new blood vessels that feed a tumor. In addition     to blocking the formation of new blood cells in tumors, cabozantinib also blocks pathways     that may be responsible for allowing cancers cells to become resistant to other     anti-angiogenic drugs. Cabozantinib has been studied or is being study in research studies     as a possible treatment for various types of cancer, including prostate cancer, brain cancer,     thyroid cancer, lung cancer, and kidney cancer.      In this research study, the investigators wish to learn if cabozantinib is effective in     treating patients with pancreatic neuroendocrine and carcinoid tumors.   "
138947|NCT01466023|"     Transient hypothyroxinemia of prematurity (THOP) is a typical entity of the preterm infant,     affecting the majority of preterm infants, born less than 30 weeks of gestational age. It is     defined as a temporary postnatal reduction from cord values in serum levels of T4 and FT4,     but with normal thyroid-stimulating hormone (TSH) levels.The etiology of THOP is complex and     multifactorial. Loss of maternal T4, limited postnatal thermogenesis, hypothalamic-pituitary     immaturity, limited thyroid gland reserve, persistent fetal thyroid hormone metabolism and     predisposition to nonthyroidal illness syndrome are several factors that contribute in less     or more intensity to THOP.The association between THOP and poor neurodevelopmental outcome is     well established and several therapeutic clinical trials have been set up. However, there is     currently no evidence for prophylactic or therapeutic supplementation with thyroxine (T4) for     premature infants with THOP. One study of van Wassenaer et al. showed a beneficial effect of     treatment of THOP in a subgroup of preterm infants with gestational age less than 28 weeks,     but a reverse effect in the group with a gestational age of 29 weeks. This is an illustration     of the limited comprehension of the pathophysiology of THOP.      Although studies about THOP usually involves the preterm infants born at 33 weeks or earlier,     one study of Paul et al. showed a decreased thyroid function in late preterm and term infants     with respiratory distress syndrome as function of severity of illness. Unpublished data of     our center showed also the presence of THOP, although less frequent, in the group of late     preterm infants. Other data about this group of preterm infants are scarce.      During the first half of pregnancy, the fetus is completely dependent of maternal thyroid     hormone supply and the fetal thyroid gland starts thyroid hormone secretion from about 17-19     weeks of gestational age. Conditions of maternal (sub)clinical hypothyroidism are associated     with complications like hypertension, preterm birth, low birth weight, placental abruption,     and fetal death. One can wonder if there are compensating mechanisms in the placenta,     providing the fetus with sufficient thyroid hormone in cases of compromised thyroid supply.     One study showed that total placenta deiodinase type 3 (D3) activity in pregnancies with     severely hypothyroid fetuses was not significantly lower than in euthyroid controls. Two     studies showed increased monocarboxylate transporter 8 (MCT8) and decreased MCT10 expression     within placentae of pregnancies complicated by IUGR. As far as we know, nothing is known     about possible compensating effects in placentae of mothers with subclinical hypothyroidism     and the possible influence on the development of THOP.      Maternal subclinical hypothyroidism during pregnancy is a predisposition for the development     of overt hypothyroidism. The influence of maternal thyroid antibodies during pregnancy     towards thyroid hormone function of the fetus and consequently neurodevelopmental outcome is     still not clear. One single study of Negro et al. showed that euthyroid pregnant women who     are positive for thyroid peroxidase antibodies (TPOAb) develop impaired thyroid function,     which is associated with an increased risk of miscarriage and premature deliveries. They also     showed that substitutive treatment with levothyroxine (LT4) is able to lower the chance of     miscarriage and premature delivery.A study of Pop et al. concluded that children of pregnant     women who had elevated titers of TPO-Ab but normal thyroid function are at risk for impaired     development.Nothing is known about the possible influence of maternal thyroid antibodies     towards the development of THOP, although a theoretical link is possible.      The investigators want to investigate whether there are compensatory mechanisms in placentas     of premature born infants and whether the maternal thyroid hormone condition is a prediction     of the development of THOP in the premature infant. The investigators want to investigate the     differences between several groups of preterm infants: 24-28 weeks, 28-32 weeks and 32-36     weeks. The further aim of this study is to investigate the impact of maternal thyroid hormone     condition during pregnancy on neurodevelopmental outcome of the neonate.      In Belgium, 8% of the newborns are born preterm. There are about 2000 deliveries each year in     the University Hospitals Leuven. Between 2 and 5% of all pregnant women are considered to     have subclinical hypothyroidism and preterm birth is almost 2-fold higher in women with     subclinical hypothyroidism.The incidence of THOP is 30 %. We performed a statistical power     calculation with a confidence level of 95%. Given the above data and with the assumption that     50% of the premature babies born to a hypothyroid mothers will develop THOP, we need to     include 320 patients who give premature birth to obtain a statistical power of 80%.     Therefore, the inclusion time will be 2 years.   "
138948|NCT01466010|"     Purpose of the study:      To retrospectively determine the clinical results in an unselected group of consecutive     patients with osteoid osteoma treated by surgery.      Materials and Methods:      In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma at     any location, the clinical symptoms and imaging findings (radiographs and computed tomography     (CT)) were assessed before and after surgery. There were no exclusion criteria for this     study. A good response was defined as disappearance of symptoms that were manifested at     presentation and were attributed to osteoid osteoma. Clinical assessment after the procedure     was performed prior to discharge; within 2 weeks after the procedure; and at 3, 6, and 12     months follow-up. After 24 months, a postal questionnaire was used for assessment.     Radiographic evaluation (radiographs and thin-slice CT) was performed routinely     pre-operatively and one year after surgery.      In case of persisting or recurring symptoms the follow-up protocol was again performed     according to the initial protocol.      All patients gave their informed consent both for the surgical intervention as for the use of     their patient data in this retrospective study.   "
138949|NCT01465997|"     Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as     monotherapy in newly or recently newly diagnosed subjects with primary safety variables     including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs,     reporting of Serious AEs (SAEs).   "
138950|NCT01465984|"     The purpose of this study is to determine whether Iv paracetamol is as effective as Iv     Morphine sulfate on control of the acute pain in Patient with limb trauma.   "
138951|NCT01465971|"     One of the major challenges in adapting to high altitudes is that with increasing altitude     sleeping quality declines rapidly. Thus, the night sleep can only provide limited to none     regeneration. It usually takes a prolonged stay at a constant altitude to adapt sufficiently     to the altitude and to have a refreshing night sleep. 1975 Reit et. al showed in their     EEG-recordings that the sleep architecture (the regular succession of the particular sleep     phases) is disturbed by repeating arousals which occur due to an irregularity in the     breathing rhythm.      The purpose of this study is to create a better understanding of the underlying mechanisms     that lead to failed acclimatization and AMS, due to sleep disturbance.   "
138952|NCT01465958|"     The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and     tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to     intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age     with Primary Immunodeficiency.   "
139004|NCT01465269|"     The aim of this study is to determine the effectiveness of holistic group treatment program     (called Group Interactive Structured Treatment, or GIST) to improve social communication     skills for individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative     intervention, those receiving the GIST intervention will show improved social competence,     improved quality of life, and stronger group cohesion.   "
138953|NCT01465945|"     Transanal Endoscopic Microsurgery (TEM) is a minimally invasive technique used to remove     rectal tumours. After the tumour has been removed from the rectum, the surgeon has a choice     to close the defect or leave the defect open and naturally close. Currently, both options are     accepted as standard care.      Leaving the defect open to close naturally has some possible advantages, including shortened     operation time and similar rates of postoperative complications. However, there is some     concern that not surgically closing the defect may lead to more postoperative pain and delay     in recovery.      The study will be a double blind randomized controlled trial and determine whether patients     who have rectal wall defect sutured closed have less post-operative pain compared to patients     whose defect is left open.   "
138954|NCT01465932|"     The program of stretching, strengthening and proprioception is more effective than stretching     and strengthening program in nursing, with rotator cuff disorder, according to indicators of     quality of life and job satisfaction.   "
138955|NCT01465919|"     The purpose of this study is to evaluate the anti-depressive efficacy of mirtazapine in     depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with     chronic hepatitis C.   "
138956|NCT01465906|"     Phrase: IV      Indication: dyspnea symptom of chronic obstructive pulmonary disease (COPD)      Objective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium     bromide for relieving dyspnea symptom of COPD      Design: a multi-centre randomized parallel blank control study      Case number: test group 80, control group 80, totally 160      Site number:7      Study period: 2010.9 - 2011.8   "
138957|NCT01465893|"     This study examines the effect of vitamin D on Retinal changes in patient with optic     Neuritis.   "
138958|NCT01465880|"     The purpose of this study is to develop a fit-for-purpose biochemical verification tool that     can be used to detect concomitant use of a few (less than 5) conventional cigarettes.   "
138968|NCT01465750|"     Cancer is the leading cause of mortality in the investigators country. According to the     statistics of the Department of Health, the incidence of ovarian cancer increased in recent     years and the mortality rate is highest in all gynecologic malignancies in Taiwan. Ovarian     cancer becomes a more and more important disease gradually in the field of gynecologic     malignancies. The classification of histology in ovarian cancer included epithelial ovarian     cancer、germ cell tumors、sex-cord cell tumors…etc. Epithelial ovarian carcinoma is the most     common ovarian cancer clinically. Early diagnosis is difficult due to the lack of obvious     initial symptoms, so ovarian cancer patients are usually at advanced stage when the diagnosis     is confirmed. The prognostic parameters for ovarian carcinomas include tumor stage,     histological subtype, degree of malignancy, residual tumor after surgical intervention and     the response to chemotherapy. However, the possible etiology and mechanism of ovarian cancer     is still unclear. However, there is no epidemiologic data of ovarian cancer in Taiwan.     Therefore the investigators propose this study to use Taiwan registry database provided by     Department of Health to analyze the epidemiology and prognosis of ovarian cancer patients in     Taiwan.   "
138959|NCT01465867|"     Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab)     autoantibodies are strongly associated with an increased risk of miscarriage and premature     deliveries in euthyroid pregnant women. Replacement of thyroxine (LT4) or other     supplementations in euthyroid-Ab positivity during pregnancy has not been established. The     development of a safe and effective intervention that modulates inappropriate inflammatory     responses could be a very important component of prevention against adverse health outcomes     during pregnancy.      The anti-oxidant Selenium (Se) suppresses autoimmune destruction of thyrocytes and at daily     dose of 200 mcg and 100 mcg decreases titers of serum TPOAb and TgAb also in Se-non-deficient     patients with autoimmune thyroiditis (AIT).      The use of Se in AIT has been shown to reduce the incidence of postpartum thyroiditis and     hypothyroidism.      Women with recurrent pregnancy loss had lower Se levels and Se deficiency has been implicated     in the pathogenesis of AIT and in the impairment of T/B cell-mediated immunity.      The purpose of the present study is performed to establish the effect of Se supplementation     in euthyroid women with AIT (pregnant and in whom embryo transfer is expected within 60 days)     on Ab trend, thyroid function and structure, implantation rates, pregnancy rates, pregnancy     outcome and number of obstetrical, fetal and neonatal complications.   "
138960|NCT01465854|"     Lung cancer in non-smokers (LCINS) is an increasing public health problem. The BioCAST     (IFCT-1002) study, promoted by Intergroupe Francophone de Cancérologie Thoracique (IFCT),     focuses on this entity. It is a national, multicentric, prospective epidemiological study.     Main objective is to describe the clinical and molecular epidemiology of LCINS in a large     French cohort composed by cases newly diagnosed in participating centres (around to 1000     patients expected). The clinical component of the study is based on collecting data directly     from the patient through a standardized questionnaire during a telephone interview with a     health professional. The biologic component includes a blood sample collection. A large     genomic-wide association study and an epigenetic study are also planned. BioCAST hopes to     provide concrete answers to clinicians and patients questions about this new and frequent     entity.   "
138961|NCT01465841|"     This is a prospective, multi-center study of patients with intracranial or peripheral     aneurysms who are treated by the PC 400 System. The primary objective is to gather post     market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial     and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral     aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each     patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long     term follow-up to one year will be conducted in accordance to the standard of care at each     participating hospital.   "
139005|NCT01465256|"     The purpose of this study is to determine if the use of aspirin prior to colonoscopy     increases the risk of post polypectomy bleeding. The primary end point is comparison of     bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit     group. The secondary end point is analysis of risk factors which affect early or delayed post     polypectomy bleeding.   "
139006|NCT01465243|"     To determine whether dose escalation can provide a better survival to patients who failed     with icotinib at routine dose.   "
139007|NCT01465230|"     This study will determine whether or not Lenalidomide improves effectiveness of treatment for     chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the     disease (bendamustine and rituximab).   "
138962|NCT01465828|"     Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in     patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention     (PCI) with drug eluting stent(s. Interindividual variability in platelet response to     clopidogrel has been reported, with several mechanisms being implicated for high     post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated     with an increased risk of adverse events after PCI. Studies in patients on chronic     clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently     present and independently predictive of adverse events. Optimization of platelet inhibition     in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12     inhibitors is a controversial issue, mostly studied in post PCI patients, while no data     exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel     treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled     will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg     a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR     measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours     after the last study-drug dose, will follow by crossover directly to the alternate therapy     for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will     return for the clinical and laboratory assessment as did on Day 14 visit.   "
138963|NCT01465815|"     This phase I/II trial studies the side effects and best dose of linsitinib when given     together with erlotinib hydrochloride and radiation therapy after surgery in treating     patients with advanced or recurrent head and neck cancer. Erlotinib hydrochloride and     linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation     therapy together with erlotinib hydrochloride and linsitinib may kill more tumor cells.     Giving these treatments after surgery may kill any tumor cells that remain after surgery.   "
138964|NCT01465802|"     To assess the impact of prophylactic treatment on the incidence of adverse events in advanced     NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To     assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence     of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1     mutation, HER-2 mutation or HER-2 amplification).   "
138965|NCT01465789|"     The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic     risk in children. The study hypothesis is that a combination of salivary biomarkers will     predict the presence of risk factors including impaired fasting glucose, hypertension and     dyslipidemia and will reflect changes in these risk factors over time.   "
138966|NCT01465776|"     This pilot phase I trial studies freeze-dried black raspberries in treating patients with     oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to     keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat     oral cancer   "
138967|NCT01465763|"     This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in     patients with moderate to severe ulcerative colitis who have failed or be intolerant to one     of following treatments for ulcerative colitis: oral steroids,     azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.   "
138999|NCT01465347|"     This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with     the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in     adults. All patients received TSC in the study. The objective of the study was to evaluate     the effect of TSC on survival and tumor response in patients with GBM while establishing an     acceptable patient risk profile.   "
138969|NCT01465737|"     Endometrial cancer is the second most common gynecologic cancer in Taiwan. Two types of     endometrial cancer may be distinguished by standard clinicopathologic criteria; type I tumors     are of low grade, endometrioid histology, estrogen related, and have a good prognosis,     whereas type II tumors are high grade, of non-endometrioid histologies, unrelated to     estrogen, and have a poor prognosis. Several clinicopathological parameters were reported to     correlate with prognosis of endometrial cancer including tumor FIGO stage, cell type,     cytological grading, depth of myometrial invasion, tumor size, lymph node status, and etc.     However, there is no epidemiologic data of endometrial cancer in Taiwan. So the investigators     propose this study to use Taiwan registry database provided by Department of Health to     analyze the epidemiology and prognosis of uterine cancer patients in Taiwan.   "
138970|NCT01465724|"     The current prevalence of hypertension as part of the metabolic syndrome is substantial and     is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous     system (SNS) activity has been identified as a common and key factor in disease states as     obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to     the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation     (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central     nervous system, has been shown to be an effective means of modulating elevated SNS activity.      This current study is an observational feasibility study, with the aim to investigate the     effect of renal denervation on changes in insulin resistance and blood pressure in patients     with obesity related hypertension. The investigators will study different variables: a     laboratorial set, a set of blood pressure measurements and a set of investigations in the     vascular laboratory.      Hypothesis        -  The investigators hypothesize that renal denervation has a beneficial effect on insulin          resistance.        -  The investigators hypothesize that there will be no complications related to the device          or procedure.   "
138971|NCT01465711|"     The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein     (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit     after abdominal surgery and compare PPS with other blood parameters, including C-Reactive     Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin (PCT).   "
139015|NCT01465126|"     Background: Collagen IV-related nephropathies can lead to End Stage Renal Disease.     Experimental studies have shown renin angiotensin aldosterone system blockade can reduce     proteinuria and preserve renal function. In humans there is no proven treatment. Methods:     This is a retrospective study of patients with Collagen IV-related nephropathies and     proteinuria treated with enalapril analyzing the evolution of proteinuria and renal function,     as well as predictive variables of progression to end stage renal disease. Outcome was     creatinine clearance < 60 ml/min/1.73m2.   "
138972|NCT01465698|"     NURSE-RCT is a randomized controlled trial which aims at prevention of evolution of chronic     low back pain (LBP) and related disability in female nurses.      The study investigates the effectiveness and financial feasibility of six months     neuromuscular training and counselling, and their combination on LBP, movement dysfunction     and fear-avoidance behaviour.      The target for neuromuscular training is to reduce movement dysfunction and motor control     impairments, caused by trauma and subfailure injuries of spinal ligaments. Training aims at     enhancement of motor control of lumbar neutral zone in different positions and movements,     balance, coordination, trunk muscle endurance and leg strength.      The target for counselling is change in attitudes and behaviour, which help to reduce the     fear of pain and encourage to physical activity and other physical tasks.      The hypothesis is that together neuromuscular exercise and counselling have a stronger     influence on LBP, movement dysfunction and fear-avoidance behaviour than either used alone.      Assessments of effectiveness will be conducted after six, 12, and 24 months of the beginning     of interventions.   "
138973|NCT01465685|"     This study compares the interactive emotional/subjective effects of single doses of     3,4-methylenedioxymethamphetamine (MDMA, ecstasy) and methylphenidate, a dopamine (DA) and     norepinephrine (NE) transporter blocker, in healthy subjects. The primary goal is to     determine the role of transporter mediated DA and NE release in the subjective response to     MDMA in humans. The investigators hypothesize that methylphenidate will attenuate the     subjective response to MDMA.   "
138974|NCT01465672|"     Water imbalance and consecutive electrolyte disturbances are common in the postoperative     course of neurosurgical patients after pituitary surgery. Diabetes insipidus (DI) may     complicate the postoperative course in as many as 30% of patients. Early and accurate     diagnosis of water and electrolyte disturbances postoperatively is important for an adequate     fluid and drug administration. However, identifying the causes is challenging/ ambiguous in     clinical practice. Levels of antidiuretic hormone (ADH) might contribute to a straightforward     diagnosis, though, its measurement is cumbersome. ADH is derived from a larger precursor     peptide along with copeptin, which is a more stable peptide directly mirroring the production     of ADH. Copeptin can be assayed readily in plasma. Aim: To investigate whether copeptin can     accurately diagnose postoperative disturbances of water homeostasis (i.e. Diabetes insipidus     and SIADH) in a cohort of patients undergoing intracranial tumor surgery.   "
138975|NCT01465659|"     This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib     hydrochloride when given together and to see how well they work in treating patients with     advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of     tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for     tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective     treatment for patients with PNET.   "
138976|NCT01465646|"     The purpose of this study is to measure the area under the curve (AUC0-48h; extent of     systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine     (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as     tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered     as a reference solution without iodine.   "
138977|NCT01465633|"     The purpose of this study is to measure the area under the curve (AUC0-48h; extent of     systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine     (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as     tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered     as a reference solution without iodine.   "
138978|NCT01465620|"     Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic     syndrome can induce a peripheral neuropathy. To investigate the effect of physical training     and diet education on neuropathic symptoms and neurophysiological parameters of patients with     metabolic neuropathies.   "
138979|NCT01465607|"     This project seeks to determine the personal and organizational conditions that are most     conducive to the widespread adoption by community-based organizations (CBOs) of effective     programs for reducing the spread of HIV and other sexually transmitted infections (STIs).     Taking a brief, single-session counseling program (called Mujer Segura) that has been     proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities     along the U.S. border, this project will study the implementation of the program in CBOs in     12 additional cities throughout Mexico to determine how best to ensure that the program     remains true to the original model and retains its effectiveness. Mexico has been chosen     because HIV is a global problem that respects no international borders, and because HIV     prevention programs that can be implemented in settings with limited resources are urgently     needed in many parts of the world.   "
138980|NCT01465594|"     The study aims to show the technical feasibility of the suprapubic urinary diversion after     endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the     patients with at least the same catheter complication rate in comparison to the urethral     urinary diversion.   "
138981|NCT01465581|"     The target population of this study is children with primary or secondary daytime urinary     incontinence, who have failed to improve adequately despite compliance with at least 6 months     of standard medical therapy.      The study hypothesis is that patients who under go cutting the filum terminale - the     string-like lower end of the spinal cord - will have improved bladder function at 6-month     follow up.      Bladder function and its effects on quality of life will be measured before surgery and at     6-month follow up.   "
138982|NCT01465568|"     The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment     of osteoporosis in patients using bisphosphonates.   "
139016|NCT01465113|"     This study is being conducted to determine if vitamin D supplementation increases the level     of a protein that may be involved in decreasing the risk of esophageal cancer in patients     with Barrett's esophagus. Subjects with Barrett's esophagus will take vitamin D     supplementation for 2-12 weeks depending on the severity of their condition, and receive an     upper endoscopy procedure before and after vitamin D supplementation trial.   "
146197|NCT01370681|"     The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose     combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to     healthy subjects.   "
138983|NCT01465555|"     The specific aims of the project are to conduct a three-phase study to develop a data-driven     Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and     test its efficacy, as follows:      Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that     predicts early treatment attrition; adapt elements of a cognitive behavioral intervention     (CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence     measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three     monitoring assessments to inform counselors when a client is at High Risk to leave treatment.      Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the     study measures/procedures.      Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose     counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors were     assigned to TAU (control condition). The primary hypothesis is that clients who evidence a     High Risk for attrition will have longer lengths of stay in the Clinical Alerts + CBI     condition than High Risk clients in the control condition. Secondary client hypotheses are     that High Risk clients in the Clinical Alert + CBI condition will attend more treatment     sessions, have more drug-free urine results, and receive more ancillary services than High     Risk clients in the control condition.   "
138984|NCT01465542|"     Retrospective chart review of patients who receive N-acetylcysteine for Acetaminophen(APAP)     toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology     and Toxicology division in the management of APAP ingestions.   "
138985|NCT01465529|"     The purpose of this study is to determine the safety and local tolerability of multiple dose     administration of inhaled OligoG in CF subjects. Particular emphasis will be put on local,     clinical tolerance, pulmonary function and pulmonary adverse events. The secondary purpose is     to monitor the effect of multiple dose administration of inhaled OligoG on various efficacy     variables, such as mucolytic activity, lung function, respiratory symptoms, Quality-of-Life     and microbiological outcome measures.   "
138986|NCT01465516|"     Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics     compared to historical control. There is no difference in SVR between patients with an     undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks     of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV     RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy     and 12 weeks of PR.   "
138987|NCT01465503|"     Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of     the most common complication of PCI and adversely affect in-hospital, short- and long-term     outcome.As bivalirudin proved its effectiveness in decreasing haemorrhagic events during PCI,     its administration may be advocated in subjects deemed at high risk of bleeding.Objective of     the present trial is to compare the safety and effectiveness of procedural use of bivalirudin     in comparison to unfractionated heparin (UFH) in patients undergoing PCI deemed at high risk     of procedural bleeding.   "
138988|NCT01465490|"     This is a three-staged study to develop and evaluate a monitoring instrument and associated     intervention, as follows:      Stage 1 - Develop and determine the reliability, validity, and sensitivity to change of a     brief Multidimensional Monitoring Instrument (MMI) for clients in outpatient substance abuse     treatment (SAT).      Stage 2 - Develop a Monitoring and Feedback Intervention (MFI) that uses the MMI. As part of     this process, create a manual, training materials, and competence and adherence measures, and     conduct a feasibility study within an outpatient SAT unit to refine the intervention and     associated materials and measures.      Stage 3 - Conduct a randomized clinical trial (RCT) to determine the preliminary efficacy of     the MFI compared to treatment as usual (TAU) for clients in outpatient SAT. In this pilot     study, it is hypothesized that the MFI will positively impact the treatment process, and     short-term, during treatment, outcomes.   "
139000|NCT01465334|"     The main purpose of this study is to examine how two separate groups of 17p deletion Chronic     lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular     combination of drugs. The two groups are those participants who have previously received     treatment for their CLL and those who have not yet received any treatment. The combination of     drugs is Ofatumumab and High-Dose Methylprednisolone (HDMP) first followed by Ofatumumab and     Alemtuzumab. All three drugs are FDA approved and have known activity in treating 17p CLL. We     hope that by combining these drugs together in this study, they will have more benefit than     each one alone and that the subjects' CLL will be significantly impacted.   "
138989|NCT01465477|"     Fibromyalgia is a clinical syndrome characterized by the presence of chronic widespread pain     accompanied by tenderness and fatigue. Central sensitization is considered to be a major     pathogenetic feature of fibromyalgia. While the etiology of fibromyalgia is incompletely     understood, it is generally considered to result from the interaction between an appropriate     genetic background and the exposure of a susceptible individual to various inciting     triggers. These have included among others physical trauma, infection, stress etc.      The possible role of vaccination in causing or exacerbating fibromyalgia has been previously     raised. Thus, gulf war syndrome, an entity with considerable clinical overlap with     fibromyalgia, has been considered to have a possible link with the exposure to multiple     vaccinations. More recently a theory has been advanced regarding the possibility that     vaccination - related adjuvants may induce a multisystem disorder characterized by symptoms     such as fatigue, cognitive impairment and arthralgia (the so called ASIA syndrome).      The investigators have previously established the safety and efficacy of influenza     vaccination in Rheumatoid arthritis patients.      In view of this background it is of considerable clinical importance to ascertain both the     efficacy and safety of vaccination in patients suffering from fibromyalgia.   "
138990|NCT01465464|"     The purpose of this study is to compare the overall survival (OS) for Orantinib in     combination with transcatheter arterial chemoembolization (TACE) versus placebo in     combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).   "
139081|NCT01464255|"     This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week     crossover, daily wear regimen.   "
139082|NCT01464242|"     The purpose of this study is to determine whether adding pentoxifylline to treatment of     American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of     clinical response without diminishing safety, and to identify immune correlates of the     healing response.   "
138991|NCT01465451|"     The purpose of this study is to investigate efficacy and safety of intra-operative     chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The     hypothesis is intra-operative intervention might be the best timing for cancer cells killing     by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor     debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for     intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU     injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into     portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction,     and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The     controlled arm receive curative resection only. All the other treatments will stick to the     guidelines.   "
138992|NCT01465438|"     Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a     estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a     progressive, erosive arthritis causing severe disability and increased mortality.      The biologic treatment infliximab and etanercept have recently been introduced for treatment     of PsA and psoriasis, and current data indicate a higher efficacy than with previously     available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but     preliminary data are encouraging. The improved treatment options have increased the need for     sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient     therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography     (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not     yet sufficiently studied, methods for this.      The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel     imaging- and biomarkers can provide additional information, compared to clinical measures and     radiography, concerning activity, destructive progression and prediction of therapeutic     response in PsA patients receiving adalimumab. The perspective is a potential improvement in     diagnosis, monitoring and prognostication of patients with PsA.   "
138993|NCT01465425|"     The ACRIN 7151 trial will use medical records abstraction data from participants with     extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to:     1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures     associated with ECFs reported on computed tomography colonography (CTC), delineated by type     of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization,     and interventional procedures, delineated by type of ECF; and 3) evaluate the     clinical/pathologic diagnoses associated with indeterminate but potentially significant ECFs.     These data can be used to incorporate ECFs into existing models on the cost-effectiveness of     CTC in colorectal cancer screening and can potentially be used to develop guidelines for the     reporting and management of ECFs.   "
138994|NCT01465412|"     The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after     administration of a single 5 mg oral dose of preladenant in participants with hepatic     impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with     participants with mild hepatic impairment. Part 2 compares healthy volunteers with     participants with moderate hepatic impairment. Healthy volunteers in each part of this study     are to be matched with participants with hepatic impairment by race, age, gender, and body     mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI,     the area under the concentration-time curve from time 0 extrapolated to time of the last     quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched     healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within     the interval [0.50, 2.00].   "
138995|NCT01465399|"     Immediately following tooth removal, a healing process begins that affects the eventual     alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing     are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a     poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring     expensive and time-consuming reconstructive surgeries, or even the inability to be corrected.     The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic potential effect     to minimize the consequences of this aggression, promoting the regeneration of both hard and     soft involved tissues.   "
138996|NCT01465386|"     This phase II trial studies how well bortezomib works in treating patients with high-risk     acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth   "
138997|NCT01465373|"     The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment     techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.   "
138998|NCT01465360|"     The purpose of this study is to assess the performance of AclarusDx™, an investigational     blood test detecting gene expression information, and intended to help physicians in making     an Alzheimer's Disease diagnosis in patients having memory impairments.   "
139002|NCT01465295|"     The purpose of this clinical trial is to study a new method of treatment for patients who are     diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine.     The treatment consists of the surgical implantation of a new medical device called the     HemiBridge™ Clip. This medical implant device has never been used in humans. SpineForm,     LLC, the developer of the HemiBridgeTM System has designed this scientific clinical trial, to     evaluate the safety of the use of this device in humans. Information collected from patients     treated with this new device shall be used to determine the initial safety of the new device.      The FDA has approved the use of the HemibridgeTM System for this research study in 6 (six)     pediatric patients who have idiopathic scoliosis.      This procedure is intended to stop additional curvature of the spine by redirecting growth of     the bones of the spine (vertebrae). To accomplish this, the patient undergoes a surgical     procedure to securely attach small metal clips (HemiBridge™ Clips) to the outer side of each     vertebra involved in the curvature. The HemiBridge™ Clip forms a bridge between each     vertebra and is intended to hold the vertebrae in place to prevent the spine from curving any     further.   "
139003|NCT01465282|"     The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327     ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up     to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.   "
139008|NCT01465217|"     Uncontrolled high blood pressure (HBP) is a major public health concern and leading cause of     cardiovascular disease worldwide. The HBP crisis is particularly onerous to African Americans     as they are disproportionately more susceptible to HBP than non-Hispanic White Americans.     Poor adherence to prescribed medication regimens is a major problem, as only about half of     patients who have been diagnosed with hypertension adhere to prescribed medications. Mobile     phones and text messages are becoming widely integrated into routine daily life and may offer     a simple and non-labor intensive strategy for improving the quality of medication management     through enhancing medication adherence. This proposed research will be conducted in two     distinct phases addressing three specific aims. For Specific Aim 1 (Phase I), the     investigators propose to conduct focus groups with participants from the investigators target     population in order to obtain feedback to guide the development of a mobile phone text     message system that seeks to improve adherence to antihypertensive medications. For Specific     Aim 2 (Phase II), the investigators propose to pilot test the newly developed text message     intervention with a randomized controlled trial. For Specific Aim 3 (Phase II), the     investigators propose to ascertain participant perceptions of intervention effectiveness and     satisfaction in order to guide further system refinement. In Phase I, African Americans with     uncontrolled hypertension (n=24-32) will be recruited to take part in one of four focus     groups that will help guide the development of the text message intervention. In Phase II,     African Americans with uncontrolled hypertension will be randomized to receive usual care     (n=30) vs. the text message intervention (n=30). The primary outcome in this pilot will be     change in medication adherence at one month follow-up; secondary outcomes include change in     medication self-efficacy and systolic and diastolic blood pressure at one month follow-up, as     well as participant satisfaction with the text message intervention. The proposed research     will utilize the Wayne State University (WSU) Center for Urban Studies to conduct high     quality and professionally run focus groups, the WSU Division of Computing and Information     Technology's Broadcast Message Service infrastructure for the delivery of text messages, the     WSU Center for Health Research for statistical analysis and grant management assistance, and     a diverse study team from a variety of disciplinary backgrounds at WSU. As a result, the     proposed research leverages the considerable local resources to investigate an innovative and     much needed intervention for this high-risk population.   "
139009|NCT01465204|"     This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap     (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and     Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the     causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor     in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE     will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene     and sanitation practices, and on the health and welfare of children 0-5 years old. By     introducing exogenous variation in handwashing and sanitation practices (through exposure to     the HWWS and TSSM promotion), the IE will also answer a number of important questions related     to the effect of the intended behavioral change (handwashing and improved sanitation) on     health and welfare, thus providing information on the extent to which these behaviors alter     intended development outcomes. This study uses a cluster-randomized experimental design,     whereby the geographic units called clusters (e.g. village, commune, ward, depending on     administrative structure of country) are randomly assigned to receive certain components of     the Handwashing and Sanitation interventions in the case of treatment arms, and no     Handwashing or Sanitation intervention in the case of control arms. . The final sample for     the evaluation will consist of approximately 14,000 households, randomly selected, with at     least one child between 0 and 24 months of age at baseline. Data will be collected from these     14,000 households (approximately 54,781 subjects) through household surveys, anthropometric     measurements, blood and stool samples, direct observations of behaviors, and community     surveys. The data collected will be analyzed using a differences in differences approach,     where possible, and the results will be disseminated to country officials and others     stakeholders.   "
139010|NCT01465191|"     HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for     cesarean section will be affected by the genetics of the woman's mu-opioid receptor      Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most     receive a dose of preservative free morphine with the spinal anesthetic.     Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose     administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.      The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and     opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at     the 40th amino acid of the protein, with asparagine and asparate being present in different     people. The less common variant (aspartate), present in 25-30% of the overall American     population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in     many studies to affect opioid analgesia.      This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150     micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women     will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other     genes that may affect pain and analgesic responses. The primary outcome will be the amount of     intravenous morphine patients self-administer in the 24 hours postsurgery.      The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each     dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours,     satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.      It is anticipated that there will be an interim data analysis at 150 evaluable subjects for     assessment of the dose response to morphine in the overall population; then a final analysis     at 300 subjects for the genetic effect assessment.   "
139075|NCT01464333|"     This study of Humira will be conducted to obtain information on the safety (especially     profile of malignant tumors and serious infections) and effectiveness in patients with     Crohn's disease who are receiving Humira for a long period of time.   "
139011|NCT01465178|"     It is the investigators hypothesis that the current method of evaluating vitamin D status,     measuring circulating 25-hydroxy vitamin D is not providing the full metabolic picture, and     is therefore inadequate. The investigators liken this concept to the evolution of cholesterol     where initially, total cholesterol was the only measurement, and have since determined the     importance of HDL, LDL and triglycerides in evaluating patient status. Similarly, the     investigators feel measurement of other vitamin D components such as sulfated vitamin D,     circulating vitamin D3 and 3-epi 25-hydroxy vitamin D will offer more comprehensive     information about a patient's vitamin D status.      It is our overarching hypothesis that a vitamin D assay panel, will enhance understanding     of vitamin D status. It is our expectation that the enhanced understanding based on improved     measurement capability will ultimately translate to improved definition of vitamin D status     and need for supplementation on an individual level.   "
139012|NCT01465165|"     Several lines of evidence support the existence of an underlying abnormality in brain energy     metabolism may play a key role in the biology of mood disorders. The current study utilizes     two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission     tomography (PET) and multinuclear magnetic resonance spectroscopy (MRS), to better understand     the nature of these metabolic abnormalities in major depressive disorder (MDD). The     investigators hypothesize that individuals with depression will have increased metabolic     activity as measured by PET in certain brain regions involved in mood regulation, but that     this metabolic activity will be inefficient based on MRS findings. For this study, the     investigators will study 10 medication-free, currently depressed participants with recurrent     MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication,     and up to 20 healthy control participants matched to depressed participants for age and     gender. Depressed and healthy participants will each undergo one PET scan and one MRS     scanning session.   "
139013|NCT01465152|"     This trial is conducted in Europe. The aim of this trial is to compare the efficacy of     metformin and repaglinide used alone or combined administered as initial treatment in     subjects with type 2 diabetes in which diet and exercise have failed.   "
139014|NCT01465139|"     CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune     cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety     and biological response for approximately one month or more.   "
139017|NCT01465100|"     The purpose of this research study is to determine whether partial irradiation of the liver     and liver cell transplantation can reduce the need for dietary and medical management or     could possibly eliminate the need for a special diet and medications to treat this disease     for patients with phenylketonuria (PKU) by normalizing phenylalanine levels in the body.     Phenylalanine (Phe) is a substance needed in the body that can only be obtained from the     foods people eat. People with PKU cannot get rid of Phe in their body. Large amounts of Phe     can cause problems, such as deterioration of mental function. At the present time, liver cell     transplants are experimental and have been done in only a limited number of human subjects.   "
139018|NCT01465087|"     Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic     and environmental factors. Different populations have different susceptibility to MS. The     disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.     Clinical disability is due to distraction of the central nervous system (CNS) myelin.      Repair processes are mainly noted after the acute relapse - and recovery of function can be     spontaneous. However, in severe relapses sometimes there is need for STEROID TREATMENT.      For the long term prophylaxis - following the increased understanding of the disease, in the     last 10-15 years, there are new immunotherapies available (COPAXON / TEVA; Interferon -beta).     However these can attenuate the disease (reduce the number of relapses per year) but cannot     cure it. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.      Currently there are no biomarkers available for MS (other than oligoclonal Immunoglobulin G     (IgG) in the cervical spine fluid (CSF) - which helps confirm diagnosis but require an     invasive procedure and are not correlated with disease activity nor response to therapy) and     monitoring of MS and its treatment is by magnetic resonance Imaging (MRI) - which is an     expensive procedure.      Dr Hossam Haick from the Technion developed an electronic nose based on nanomaterials for     diagnosis of diseases (e.g., cancer, kidney failure, etc.) via breath samples.The research     hypothesis is that Biomarkers of CNS inflammation and/or neurodegeneration and/or CNS repair     in persons with MS can be detected by the electronic nose.   "
139019|NCT01465074|"     Patients with schizophrenia display cognitive impairments, such as reduced attention and     problems with memory. Available medications for schizophrenia poorly alleviate memory     problems however, research indicates that nicotine improves memory. In order for there to be     memories formed, there has to be changes (neuroplasticity changes) in how the brain cells     communicate. One way to induce such changes is by using Transcranial Magnetic Stimulation     (TMS) combined with peripheral nerve stimulation in a Paired Associative Stimulation (PAS)     paradigm. The investigators laboratory has developed a novel method that measures memory-like     brain changes using electroencephalography (EEG), TMS and PAS. The present study will use     this novel method to evaluate the effects of acute nicotine gum (4mg) and placebo (regular)     gum on memory and memory-like brain changes in schizophrenia and healthy controls. The     hypothesis is that nicotine will improve memory and facilitate neuroplasticity changes in the     prefrontal cortex of patients with schizophrenia to a larger extent than in healthy controls.   "
139020|NCT01465061|"     With the rise of usage of the internet, online social networks have recently been gaining     popularity. Joining these groups can be beneficial to patients with chronic medical illness,     such as psoriasis.This was a cross-sectional online survey of psoriasis patients in the     Philippines who are members of online support groups. The survey was conducted for a period     of three months.The purpose of the research project was to describe the demographics, disease     characteristics, activities and benefits of online support groups to Filipino patients with     psoriasis. The extent to which members experience empowering processes and outcomes was also     evaluated.   "
139021|NCT01465048|"     This is an open label, human pilot study to optimise controlled human malaria infection     (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be     inoculated with PfSPZ Challenge. The route of administration and dose will vary in order to     identify the optimal regimen that achieves the greatest infection rate in volunteers with     Plasmodium falciparum. All volunteers recruited will be healthy adults aged between 18 and 45     years. Safety and infectivity data will be collected for each of the regimens.   "
139022|NCT01465035|"     This is a single blinded placebo controlled phase I study, to assess the safety and     immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with     seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over.      The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV)     is that the immune system will be stimulated to produce both influenza specific T cells and     influenza specific antibodies.   "
139023|NCT01465022|"     Objectives      To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined     oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth,     contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific     research questions:        1. To determine whether there is a difference in rates of breastfeeding continuation at 2          months and 4 months between postpartum breastfeeding women using progestin-only pills          vs. combined pills.        2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks          between postpartum breastfeeding women using progestin-only pills vs. combined pills.        3. To determine whether there is a difference in birth control method continuation at 2          months and 4 months between postpartum breastfeeding women using progestin-only pills          vs. combined pills.      Hypothesis      Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will     cause a differential in continuation of breastfeeding: 35% continuation in the combined pill     group vs. 60% in the progestin-only pill group at 8 weeks.   "
139024|NCT01465009|"     The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study     medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of     sore throat associated with a common cold. The study is designed to develop a treatment     method against sore throat associated with a common cold which will have more advantages for     patients than the methods that are currently available.   "
139091|NCT01464125|"     The aim of this study is to evaluate the role of azithromycin as a possible combination     partner for fosmidomycin to protect it from its susceptibility to recrudescent infections     when used as monotherapy for acute Plasmodium falciparum malaria while retaining its     excellent safety profile.   "
139025|NCT01464996|"     This randomized clinical trial evaluates the clinical performance of a new two-component     self-etch universal adhesive, OptiBond XTR, when applied in non-carious Class V cervical     lesions without macromechanical retention (retentive grooves or bevels). The control material     is OptiBond FL, a traditional etch/prime/bond adhesive with documented clinical     performance. Eighty non-carious Class V cervical lesions are divided into two groups to be     treated with either OptiBond XTR or OptiBond FL. Both adhesives are applied strictly     according to the manufacturer's directions. Herculite Ultra, a nano-hybrid resin-based     composite, is used as the restorative material with both adhesives. The restorations will be     evaluated at insertion (baseline), 6 months, and 18 months. An optional three-year recall     evaluation is also proposed. The investigators hypothesize that both adhesives will have     comparable performance.   "
139026|NCT01464983|"     The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg     Aspirin® (study medication) by comparing it to placebo (the control group without active     substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of     episodic tension-type headache. The study is designed to develop a treatment method against     episodic tension-type headache which will have more advantages for patients than the methods     that are currently available.   "
139027|NCT01464970|"     The purpose of this study is to determine in-vivo the effects the contralateral superficial     inferior epigastric vascular system has on the perfusion of Zone IV of deep inferior     epigastric perforator flaps.   "
139028|NCT01464957|"     Skin cancer risk is largely determined by sun exposure during childhood. This study     determines the effectiveness of a mailed intervention designed to increase sun protection for     children age 6-9 years old. The intervention includes newsletters for parents that include     risk information tailored to each child. Also included are sun protection resources such as a     swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3     consecutive years, and data collection includes telephone interviews and skin exams. The     study hypothesis is that receipt of the intervention will result in improved sun protection     of the child.   "
139029|NCT01464944|"     This study is addressed to patients suffering from an acute febrile upper respiratory tract     infection suspected to be of viral origin. The purpose of this study is to determine the     antipyretic efficacy (reduction of fever by lowering the body temperature from a raised     state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of     Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo     (comparator medication without an active substance). Despite of its common use for fever     treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin     are sparse. Therefore, the purpose of this study is to collect such data.   "
139030|NCT01464931|"     The primary objective was to evaluate the incidence of clinically significant hypocalcemia     following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic     kidney disease (CKD) and CKD on dialysis   "
139031|NCT01464918|"     This trial is to evaluate the safety and efficacy of using MASTER, a robotics enhanced     endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer     in human.   "
139076|NCT01464320|"     To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2     diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces     glomerular filtration rate.   "
139032|NCT01464905|"     The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with     relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active     comparator. The primary clinical objective selected for this Phase 3 study, the cumulative     number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted     lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance     imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the     superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.   "
139033|NCT01464892|"     Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early,     chronic, interpersonal trauma (e.g. Smucker & Dancu, 1999). So far, this protocol has not     been investigated within a controlled setting with patients with PTSD following early,     chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the     efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can     be improved by adding a stabilization phase (Skills training in affective and interpersonal     regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions     will be compared:        1. Imagery Rescripting        2. STAIR + Imagery Rescripting        3. Wait-list control   "
139034|NCT01464879|"     This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum     testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the     pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand     application   "
139035|NCT01464866|"     This study will determine the effect of nutrition supplementation on blood protein levels in     pediatric burn patients.   "
139036|NCT01464853|"     To determine whether specialized enteral nutrition support can improve oxygenation status in     critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome     (ARDS) comparing to a standard enteral nutritional formula.   "
139037|NCT01464840|"     PKAZ is a single institution study designed to evaluate the optimal dosing parameters for     azithromycin for pre-surgical cesarean prophylaxis.      Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal     tissue concentrations that adequately treat microbes commonly involved in post-cesarean     infections.   "
139038|NCT01464827|"     This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin     (RBV) in patients with chronic Hepatitis C Virus (HCV).   "
139039|NCT01464814|"     The purpose of this study is to determine the effects of the probiotic KE-99 Lactobacillus     casei when administered with omega-3 fish oil on probiotic viability, fecal make-up and     gastrointestinal (GI) health in healthy adults.   "
139092|NCT01464112|"     The purpose of this study is to evaluate the safety and tolerability and to establish the     maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.   "
139040|NCT01464801|"     Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common in     the Western world and strongly associated with obesity. No known effective treatment is     known. From animal studies, it is known that the compound resveratrol perhaps has the     potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a     food supplement though the precise effects are unknown. This project focuses on the effect of     Resveratrol on fatty liver disease. The researchers plan to investigate the effects of     Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.   "
139041|NCT01464788|"     Randomized controlled clinical trial to estimate overall treatment benefit (improvement in     disability) among stroke patients treated with rt-PA who are randomized to also receive     either low-dose Argatroban, high-dose Argatroban or neither.   "
139042|NCT01464775|"     Endometriosis is a relatively common chronic gynecological condition that affects     approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that     is characterized by the presence of endometrial glands and stroma outside of the uterine     cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility;     the severity of pain associated with this disease often leads to a considerable decrease in     quality of life.      The standard treatment for severe pelvic pain and infertility is to surgically remove     endometriotic areas. Identifying all endometriotic lesions is paramount to optimal     endometriosis debulking. The inability to see all endometriosis lesions has been thought to     be a factor for patients with little or no relief following surgery. Using the Narrow Band     Imaging (NBI) method has the potential to improve visualization of endometriosis lesions,     assist in debulking and thus, result in improved clinical outcomes.      NBI is a technique that uses a specific narrow wavelength of light to change the normal color     contrasts of the endoscopic image and improve detection of neovascularization, which is the     pathological feature of endometriosis for both superficial and deeper vascularization. This     type of imaging has the potential to offer improved discrimination of lesions, increasing     diagnostic yield as well as resulting in more complete debulking.      This study is designed to determine the degree to which NBI improves the detection and     diagnosis of endometriosis lesions. Data collected during the study will be used to test the     hypothesis that the use of NBI will improve the detection and diagnosis of endometriotic     lesions at the time of laparoscopy compared to standard visible white light examination.     Furthermore, this study will also determine the impact of the use of NBI compared to use of     white light examination on reported severity of pain at 6-weeks, 3-months, and 6 months     following surgery.      Hypotheses:      The use of NBI in addition to white light examination will improve the diagnostic yield of     endometriotic lesions at the time of laparoscopy compared to only using white light     examination.      The use of NBI in addition to white light examination will improve the sensitivity of     detecting endometriotic lesions and reduce false positives at laparoscopy compared to only     using white light examination.      Secondarily, the use of NBI will be associated with a greater reduction in pain at the     6-week, 3-month, and 6-month follow-up compared to the use of white light examination alone     because of improved lesion identification and debulking.   "
139043|NCT01464762|"     The purpose of this is a study to provide early access of TMC207 to patients with pulmonary     infection due to strains of Mycobacterium tuberculosis (M. tuberculosis) with resistance to     isoniazid (INH), rifampin (RMP), and to a fluoroquinolone (FQ) and/or injectable second line     tuberculosis (TB) drug (kanamycin, amikacin, or capreomycin) and who are unable/ineligible to     participate in any other TMC207 study. In addition, information on safety and tolerability of     TMC207 in combination with anti-TB drugs will be assessed and the results of microbiology     assessments which are recommended to be performed during the early access study will be     collected.   "
139057|NCT01464567|"     Weaning of mechanical ventilation (MV) is an essential part in management of patients with     Chronic Obstructive Pulmonary Disease (COPD) when critically ill. The best strategy to be     used has not been established.      Objective: To compare the Spontaneous Breathing Trial (SBT) in Pressure Support Ventilation     with SBT through T tube in weaning of MV in patients with COPD.      Design: Randomized Clinical Trial. Methods: This study will include patients with COPD,     admitted to the Intensive Care Unit of Hospital Nossa Senhora da Conceição, undergoing MV for     at least 48 hours. When considered by the care team ready for SBT, they will be randomized to     one of the following strategies: SBT in Pressure Support or SBT through T Tube. The primary     endpoint of this study will be the reduction in the days spent on MV. Other outcomes measured     will be mortality, extubation and success rate, time to weaning of MV, length of ICU stay and     incidence of tracheostomy.   "
139044|NCT01464749|"     Aims of the study:      This is a single blind randomized-controlled trial to test the feasibility and the effects of     a task oriented training on locomotor function, mobility and balance in multiple sclerosis     subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not be treated     with a specific physical therapy (usual care).      Subjects and methods:      60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic     (Azienda Ospedaliero-Universitaria di Ferrara).      Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented     training (experimental group) or usual care (control group) through a randomization     stratification approach, according to a block randomization of 6.      The experimental group will receive 10 task-oriented training sessions over 2 weeks (5     sessions/week=intensive training). Three subjects with a supervisor physiotherapist will take     part at the TOCT.      Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy     outcome measures will be clinical test for gait speed (10m walking test), walking endurance     (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); a     structured interview for the performance(Lower Extremity Mal); self-assessment questionnaire     for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical and psychological     impact (multiple sclerosis impact scale MSIS-29), walking ability (multiple sclerosis walking     scale MSWS-12).      Outcome measures will be assessed the week before the treatment (T0), after the treatment     (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded     to the treatment.   "
139045|NCT01464736|"     On the following tests, there would be a greater increase in the functionality of COPD     patients who underwent combined therapy than in those who only exercised: a set of activities     of daily living (ADLs), the six-minute walk test (6MWT), an incremental symptom-limited     cardiopulmonary test (CPT), and the physical functioning scale of the Short-Form 36 quality     of life questionnaire (SF-36).   "
139046|NCT01464723|"     The purpose of the study is to investigate whether the efficacy of Lucentis treatment for     exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA     polymorphisms   "
139047|NCT01464710|"     The purpose of this study is to determine if polymorphisms at rs11200638 on HTRA1 and     rs1061170 on CFH are associated with an accelerated progression to advanced AMD (wet AMD or     GA) in patients with early AMD (soft confluent drusen>120 microns ) in the study eye, and     with either early AMD or advanced AMD in the non-study eye.   "
139093|NCT01464099|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in     subjects with type 1 diabetes.   "
139094|NCT01464086|"     The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules     for the early detection of cancers in the population under study on cancer incidence at 3     years.   "
139048|NCT01464697|"     The purpose of this study is to test whether a oral micronized progesterone reduces the     Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats     in perimenopausal women. Oral micronized progesterone is molecularly identical to human     progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial     cancer in women taking estrogen in menopause. This research study will test whether     progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether     progesterone improves sleep disturbances and anxiety.   "
139049|NCT01464684|"     Investigators will characterize the body composition and metabolism of infants born from     lean, overweight or obese mothers from whom they had previously obtained a placenta and/or     cord blood as part of the earlier placenta and cord blood study (#111576)   "
139050|NCT01464671|"     The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin)     versus unfractionated heparin (UFH) in patients presenting with stable angina or silent     ischemia (positive stress test without chest pain) that undergo percutaneous coronary     intervention (PCI).      The primary endpoint of the study will be major and minor bleeding events, defined by the     REPLACE-2 trial definition, during the index hospitalization and up to 30 days post     discharge.   "
139051|NCT01464658|"     Patients with morbid obesity often develop a significant overhanging abdominal pannus.     Problems associated with an overhanging pannus can include difficulty performing routine     daily activities as well as exercise due to the cumbersome nature of the excess tissue. In     addition, the abdominal pannus tissue often becomes infected due to difficulty with hygiene     and abnormal circulation and lymphatic flow. There may also be a significant contribution     from the pannus to the patient's underlying cardiopulmonary status which is often compromised     in morbid obesity patients.      In addition to weight loss, one of the treatment strategies includes a panniculectomy. A     panniculectomy involves resection of the excess abdominal skin and fat in a wedge shape from     the lower abdomen. Purported benefits include increased ability to exercise, better quality     of life and improved cardiopulmonary function. However, there is a significant morbidity     associated with panniculectomy surgery, with wound related complications occurring in as much     as 50% of patients with this procedure.      The investigators hypothesize that the panniculectomy procedure provides long term benefits     to this patient population despite significant short term morbidity.   "
139052|NCT01464645|"     The purpose of this study is to examine the short term efficacy of the MRH system as well as     determine if operating room time is decreased using this simple, two-tray system.   "
139053|NCT01464632|"     The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative     revision rates of the EPIK™ Uni-compartmental Knee System.   "
139054|NCT01464619|"     The main objective of this study is to adapt a parenting intervention for caregivers of young     children who report depressive symptoms in primary care pediatric practices. In addition, the     study will explore the acceptability and feasibility of a validated parenting program.   "
139055|NCT01464606|"     Pleuropulmonary Blastoma (PPB) is very rare and there is no established standard or best     therapy. For many years, children with PPB around the world have been treated according to     decisions made case-by-case in many different hospitals by many different physicians. No     treatment has been tested in a large group of PPB patients.      The goal is to treat many children with one treatment program and to learn the results of the     treatment.   "
139056|NCT01464593|"     The purpose of this study is to determine the safety and efficacy of Thermodox, a thermally     sensitive liposomal doxorubicin, in combination with thermal ablation in the treatment of     hepatic colorectal liver metastases (CRLM).   "
139074|NCT01464346|"     The purpose of this study is to demonstrate the performance of the Enlite Sensor over an     entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and     buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.   "
139058|NCT01464554|"     Youth involved in the juvenile justice system have multiple problems, including an earlier     onset of alcohol and drug use and higher rates of alcohol and drug use than their peers in     the general population. This 4.5 year study will develop and evaluate a new group     intervention for youth who have committed a first time alcohol or drug offense. Teens will be     randomized to receive either usual care or the new group intervention. Teens will complete a     baseline, post-test (when they complete the intervention, which could vary for each teen but     is typically around 6-8 weeks), and a 3-month follow-up survey upon completion of the     intervention. The investigators will examine outcomes for a variety of behaviors, including     alcohol and drug use and assess whether there are differences between the teens who received     usual care and the teens who received the new group intervention.   "
139059|NCT01464541|"     Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to     the actual orbital fracture size intraoperatively in patients who needed surgical     intervention to correct the fracture.      Hypothesis: there is difference between the CT measure fracture size and the actual     intraoperative size.   "
139060|NCT01464528|"     Operations in the uterus are currently possible using a hysteroscope. One serious though rare     complication of such procedures is the development of intra-uterine adhesions. There     currently are no methods to prevent this. The aim of this study is to evaluate the safety of     using hyaluronic gel after hysteroscopic surgery.   "
139061|NCT01464515|"     This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation     (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild     Cognitive impairment). The hypothesis of the study is that high frequency treatment with deep     TMS will improve the daily functioning of patients who suffers from MCI.   "
139095|NCT01464073|"     The purpose of this study is to evaluate the efficacy of 3 of physical exercise training     programs, with a supplementation in fruits and vegetables, on body composition. 126 women     will be randomized into 3 groups (42 subjects per group). The first program will be conducted     at a relatively low intensity of effort, corresponding to the maximum rate of lipid oxidation     (LIPOXmax)measured by indirect calorimetry. The second program will be at 60% of VO2peak and     the third program will be prescribed according to the Good Practices physical Guidelines (30     minutes per day at a moderate intensity). All subjects will receive a free supplement of 5     fruits and vegetables per day during all the intervention. The intervention will last 5     months in total.   "
139062|NCT01464502|"     Heart failure patients may benefit from having a special pacemaker implanted that can make     the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy     (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in     optimal positions. Only two thirds of people respond to CRT and this may be because of     non-ideal pacing wire position. A potential marker for response is the change in heart pump     pressure change over time. The aim of this study is to use a specialised wire in the main     pumping chamber of the heart to record the pressure changes with the pacing lead in various     positions to determine the optimal position. It is postulated that the improved pressure     changes will increase the proportion of responders.      Pilot study work has shown that the work is technically feasible and safe. The initial data     has been published in a highly regarded scientific journal. This main study will be a     multicentre randomised controlled trial whereby patients will be randomised to either     standard treatment or pressure wireguided treatment. The patients in the pressurewire guided     arm will have a specialised wire implanted into the main pumping chamber of their heart via a     blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will     measure acute pressure changes over time and the pacing lead will be positioned in the site     that gives the greatest change in pressure.      If the patients in the pressurewire guided arm fare better than those receiving standard     treatment it may alter how a large proportion of heart failure patients are treated around     the world. The study requires 282 patients and is likely to take two years to complete.   "
139063|NCT01464489|"     The investigators hypothesized that increasing the cardiac output by use of atropine in     children might result in a reduction of the intubation time needed to facilitate tracheal     intubation.   "
139064|NCT01464476|"     This study will evaluate the efficacy and safety of Azimilide on the incidence of     cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular     death in patients with Implantable Cardioverter Defibrillators (ICDs)   "
139065|NCT01464463|"     The objective of this study is to compare the impact of i) Cognitive Behavioral Therapy (CBT)     combined with exercise, ii)CBT combined with euthymic therapy, and iii) 'Cognitive Behavioral     Analysis System of Psychotherapy' (CBASP) on psychometric and immunological measures in     patients with major depression.   "
139066|NCT01464450|"     The primary objective of this study is to learn about the relative bioavailability (the     extent to which the drug becomes available to the body) and pharmacokinetics (blood levels)     of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a     whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric     (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a     crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The     safety and tolerability of rivaroxaban will also be assessed.   "
139067|NCT01464437|"     This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel     group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated     with metformin for at least 3 months prior to randomization.   "
139068|NCT01464424|"     The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs.     bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with     open-angle glaucoma or ocular hypertension after 6 weeks of treatment.   "
139069|NCT01464411|"     The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy     for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.   "
139070|NCT01464398|"     The purpose of this study is to determine the effects of stress reduction on glucose, blood     pressure, quality of life and overall health and well-being in overweight or obese women,     either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction     treatment sessions will include one or more of the following activities: breathing exercises,     meditation, stretching exercises or health education activities.   "
139071|NCT01464385|"     To evaluate the sensations experienced by subjects consuming a nutritional beverage.   "
139072|NCT01464372|"     The purpose of this study is to collect data on the safety and efficacy of using an     electrical field stimulation device, compared to a sham (placebo) device, to treat urinary     urgency, urinary frequency and urge incontinence.   "
139073|NCT01464359|"     This trial is proposes to build on our experience and is designed to maximize early (day     3-14) and late (day 60-71) donor-derived natural killer (NK) cell expansion and function in     vivo. The proposed platform will allow us the unique opportunity to compare in vivo function     from a transplanted umbilical cord blood (UCB) source (presumed to contain NK progenitors     requiring education in the recipient).   "
139077|NCT01464307|"     The purpose of this study is to determine whether injections of Botulinum toxin type A into     muscles of the leg are effective in treating patients with increased muscle     tension/uncontrollable muscle stiffness (spasticity) after a stroke.   "
139078|NCT01464294|"     Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar     performance in clinical service to conventional ceramic CAD/CAM restorations.   "
139079|NCT01464281|"     A Randomized, open-label, multicenter study.      The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA     <200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap     with the NA for safety reasons). The subjects will be randomized into 2 groups:      Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week     prolonged treatment by Peginterferon alfa 2a 180µg/week.      All the patients will be followed up for 48 weeks after discontinuation of the study     medication.      Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.   "
139080|NCT01464268|"     Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing     progression of both keratoconus and corneal ectasia after surgery, as well as possibly     decreasing the steepness of the cornea in these pathologies. During previous studies of the     CXL procedure, the surface epithelial cells have been removed. Transepithelial crosslinking     in which the epithelium is not removed has been proposed to offer a number of advantages over     traditional crosslinking including an increased safety profile by reducing the risk for     infection as no epithelial barrier will be broken, faster visual recovery and improved     patient comfort in the early postoperative healing period.   "
139083|NCT01464229|"     Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of     schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological     features seem to be very promising in treating symptoms like anger and anxiety (Fava et al.,     1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well     powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone     augmentation of SSRIs among MDD outpatients in partial remission with residual anger and     irritability is warranted at this point to evaluate its efficacy, safety and tolerability on     residual anger, irritability and depressive symptoms.      Main hypothesis: Adults with MDD in partial remission, who are experiencing residual symptoms     of anger and irritability, assigned to treatment with iloperidone will demonstrate a     significantly greater reduction in the total score of the Anger/Hostility Scale of the     Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the     cross-over design.   "
139084|NCT01464216|"     The purpose of the study is to combine and correlate data from morphological and functional     MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia     with the goal being predicting of prostate cancer aggressiveness.   "
139085|NCT01464203|"     Heart disease remains the most common cause of death in the UK. Chest pain is often the first     presenting symptom in patients with heart disease, and may be a warning signal prior to a     heart attack or death. The diagnosis based on symptoms alone however is unreliable and     further testing is almost always necessary.      Rapid access chest pain clinics (RACPCs) are able to expedite the assessment of such     patients. The principal investigation used is an exercise stress electrocardiogram (s-ECG).     Although simple, cheap, and convenient, the s-ECG is often inaccurate; missing the diagnosis     or falsely suggesting the diagnosis. This can happen in as many as 25% of patients, resulting     in a delay in treatment or unnecessary further investigation.      CT Angiography (CTA) is a novel non-invasive technique where the coronary arteries can be     visualised by Computerised Tomography. In previous studies it shows a high degree of     correlation with invasive angiography, with a high accuracy for the diagnosis of obstructive     coronary artery disease. However, the technique is relatively new, and its full role is yet     to be defined in the clinical setting of a chest pain clinic. The investigators do not at     present have any information as to whether it is able to speed up the diagnosis, reduce the     need for other tests, and therefore also costs.      In this trial, the investigators aim to examine the accuracy and cost effectiveness of CTA in     patients with suspected cardiac chest pain presenting to a chest pain clinic, when compared     to the more established techniques like s-ECG, myocardial perfusion scanning and coronary     angiography. The study will enable us to establish the optimal and most cost effective     strategy for investigation of patients presenting to chest pain clinics.   "
139086|NCT01464190|"     This is a Phase 3, randomised, active controlled, multicentre extension study to investigate     the long-term safety and efficacy of PA21, a phosphate binder, for control of     hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A     (NCT01324128), subjects have already been enrolled and have been treated with study     medication for at least 24 weeks.   "
139087|NCT01464177|"     Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment     comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite     appropriate management, 90% of the patients will develop relapse or progression. After     progression, the median survival is 5.2 months (Stupp, 2009).      The treatment of GBM relapse remains investigational. Reirradiation is an option in selected     cases.      The objective of this study is to compare 2 schemes of stereotactic hypofractionated     radiotherapy in the management of recurrent GBM.   "
139088|NCT01464164|"     The purpose of this study is to determine the safety and dosing of drug Sotatercept, as a     subcutaneous injection, to stimulate production of red blood cell production. To be given     every 28 days for up to four doses.   "
139196|NCT01462734|"     MicroRNAs are important regulators of many cellular functions but their expression profile in     human vitreous is still unclear. Aim of this study is to investigate microRNA expression     profile by PCR in human vitreous of macula hole patients which is suggested to be similar to     that of healthy patients.   "
139197|NCT01462721|"     The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support     (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.   "
139089|NCT01464151|"     Both ulcerative colitis and Crohn's colitis are associated with an increased risk of     developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is     well established, several studies show that the risk varies widely between patients,     depending on the presence of risk factors. Recently, several of these risk factors were     implemented in the updated British guidelines for surveillance which are now used to     determine surveillance intervals in our center. The new guideline recommends stratification     of patients in a high, medium or low risk group depending on the presence of clinical and     endoscopic risk factors and to adjust the surveillance interval accordingly. Although these     guidelines provide a first step towards an individualized surveillance regimen, current data     regarding risk factors for IBD-associated CRC are solely based on retrospective studies.     Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed     to further optimize surveillance in the future.      Objectives:        1. To confirm established and identify new predictive factors for colorectal cancer in a          prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or          colorectal cancer will be the primary outcome.        2. To provide evidence that mucosal healing results in a significant reduction of          colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA or          anti-TNF maintenance therapy.        3. Study the expression of several tumor markers in biopsies, blood and faeces at baseline          and determine whether expression of these markers can predict dysplasia or colorectal          cancer development during follow-up.   "
139090|NCT01464138|"     This is an open label uncontrolled study to determine the efficacy of fosmidomycin and     clindamycin when co-administered orally over three days in the treatment of acute     uncomplicated Plasmodium falciparum malaria in children.      The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary     endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.   "
139096|NCT01464060|"     Helicobacter pylori (H. pylori) infects approximately 50% of the adult population and is well     recognized as the main cause of gastritis, peptic ulcer disease and gastric cancer. The cure     of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and improves     dyspepsia in a significant proportion of cases, so it is cost-effective.      Eradication therapy has changed over time. Recent meta-analyses have that the current global     eradication rate after standard triple therapy (STT) is less than 80%. Several European     studies have found even lower eradication rates, with 35-40% of cases resulting in treatment     failure, probably due to increased resistance to antibiotics in many geographical areas,     principally to clarithromycin. The usually recommended pattern in the American and European     (Maastricht III) consensus conferences from 2007 has traditionally been triple therapy,     composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or     metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. However, triple therapy was     discouraged in settings with high rates of clarithromycin resistance (15-20%) and, as such,     new strategies in order to improve the efficacy of first-line treatments are required.     Treatment failure increases antibiotic resistant strains, leads to a second treatment and a     new diagnostic test to confirm eradication. Unfortunately, it remains unknown whether there     is room for improvement in these geographical areas using clarithromycin-containing therapies     or switching to bismuth quadruple therapy should be followed instead.   "
139097|NCT01464047|"     The purpose of this post-marketing surveillance is to investigate and confirm the type and     incidence of newly identified adverse events and any other factors affecting safety and     efficacy of Sprycel® so that the regulatory authority can manage the marketing approval     properly.   "
139098|NCT01464034|"     This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated     dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients     with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to     evaluate efficacy.   "
139099|NCT01464021|"     A post-marketing uncontrolled observational study to explore and describe the effectiveness     of adalimumab, as prescribed according to the local product label, in patients with     moderately to severely active rheumatoid arthritis (RA) in China.   "
139135|NCT01463605|"     For patients who are unable to receive surgery or having local advanced esophageal cancer     stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy     for older patients because of their chemoradiotherapy intolerance. The whole world focused on     targeted therapy which has strong specialties and mild toxicities. So combined targeted     therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer.     Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and     safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal     cancer. All patients receive intensity modulated radiotherapy with conventional fraction.     Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.   "
139100|NCT01464008|"     The efficacy of combination antiviral therapy for chronic hepatitis C is influenced by many     factors. Important patient-specific factors include, age, gender, race, body weight.     Important virus-specific factors include HCV genotype and serum HCV RNA level. Finally,     important treatment-related factors include the type of interferon, dose of ribavirin and the     duration and adherence to treatment.      Despite the importance of patient- and virus-specific factors, the most important indicator     of treatment success is a rapid, profound and sustained decrease in serum HCV RNA levels     after the start of treatment.      The on-treatment virological response can thus be used to predict the probability that a     given patient will achieve an SVR if they remain on therapy. It can also be used to     individualize the duration of treatment.      In this study, treatment for patients with chronic hepatitis C was individualized on the     basis of clinical characteristics and the on-treatment virological response. The aim was to     investigate the usefulness of undetectable HCV RNA levels at week 4 (RVR) and 12 in tailoring     the duration of treatment and predicting SVR in Chinese patients with chronic hepatitis C.   "
139101|NCT01463995|"     This study examines the prognostic properties of immune parameters, clinical scores,     electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of     functional outcome one year after treatment on a neurological intensive care unit.   "
139102|NCT01463982|"     The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan     in combination with capecitabine   "
139103|NCT01463969|"     In the present study, serum pentraxin 3 level and its relationship with insulin resistance     were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3     level is increased in patients with PCOS and it is positively correlated with HOMA-IR.   "
139104|NCT01463956|"     Evaluation of efficacy of triple therapy with pegylated interferon, ribavirin, and boceprevir     in patients with genotype 1 chronic hepatitis C, who are treatment-naive, have relapsed, or     are non-responders with cirrhosis and awaiting liver transplantation, with a MELD score less     than or equal to 18   "
139105|NCT01463943|"     The study's objective is to evaluate the efficacy and safety of two formulations for the     prophylactic treatment of diarrhea in subjects using antibiotics.   "
139106|NCT01463930|"     Information provided to patients modifies their expectations with surgery. The effects of     preoperative audiovisual information on expectations with total knee replacement (TKR) have     not been investigated. The purposes of this study were to investigate the effectiveness of an     educational videodisc on the modification of pre-operative patients' expectations with TKR     and to find a biophysical profile of subjects in whom this videodisc could be most effective.     It was hypothesized that patients receiving standard information plus additional medical     information through audiovisual videodiscs would modify their pre-operative expectations more     than those only receiving the standard information through medical interviews.   "
139107|NCT01463917|"     This is a comparison between Hypertonic versus isotonic solution in a double blind randomized     trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal     branch.      Hypertonic solution should provide better tolerance for heart mobilization with less volume     expansion and less drugs.   "
139127|NCT01463657|"     Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will     be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial     fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.   "
139108|NCT01463904|"     Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified     duodenal switch. It is performed on morbid obese patients and severe T2DM patients with     obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a     remission of T2DM. A lower complication rate than for duodenal switch is expected.   "
139109|NCT01463891|"     To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with     inoperable or recurrent breast cancer   "
139110|NCT01463878|"     Primary Objective:      To determine the effects of a diabetes specific enteral formula compared to a standard     formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose     and glycemic variability in a homogenous group of critically ill patients in a neurological     ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor.     The primary end points will be the difference between the mean blood glucose levels and the     glucose variability between the control and intervention groups for the time period that the     patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.      Secondary Objectives:      To determine the effects of the diabetes specific versus standard tube feeds on the change in     muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients     ICU stay.   "
139111|NCT01463865|"     In this study the investigators wish to compare the effect of a selective axillary nerve     block to placebo in patients undergoing arthroscopic shoulder surgery.      It is the investigators hypothesis that the amount of morphine consumption in the first 4     hours postoperatively in the intervention group will be significant lower than in the placebo     group.   "
139112|NCT01463852|"     In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are     scheduled to initiate treatment per the recommendations of their primary oncologist, will     receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if this     single dose will induce rapid cell death in isolated CLL cells.      Vincristine 2 mg will be administered to the participants intravenously over 5 minutes. Blood     samples will be collected from an intravenous line inserted into the contralateral limb to     that where the vincristine was given, at time zero (pre-vincristine treatment), immediately     after vincristine administration (within 2-10 minutes upon completion of administration) and     at 1, 2, 4 and 6 hours post-vincristine treatment. Patients will then at a later date receive     chemotherapy treatment as prescribed by their primary oncologist.      Within 7 days of vincristine administration, participants will receive a phone call from the     research nurse to discuss potential toxicities. At the time of the initiation of standard     chemotherapy treatment, the Principal Investigator will also meet with the participant to     collect information regarding adverse events.   "
139144|NCT01463488|"     Study objectives:        -  Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety,          tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.        -  Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and          tolerability of a single intra-articular dose of SAR113945.   "
139198|NCT01462708|"     The purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as     a tool to evaluate the activity of the CB-1 receptor in the brain.   "
139113|NCT01463839|"     Sleep is a vital physiological function for the maintenance of health and quality of life.     Harmful, non-nutritive and parafunctional oral habits are believed to have a negative effect     on adequate rest at night. The aim of the present study was to determine associations between     quality of sleep and harmful oral habits among children aged three to six years. Fifty     children from a private school in São Paulo (Brazil) were evaluated using two questionnaires     on sleep quality and harmful oral habits. The data were submitted to descriptive analysis.     The chi-square test was employed for the categorical variables and analysis of variance     (ANOVA) was carried out to compare mean values. The Student's t-test was used for all     analyses, with the significance level set at 5%. The SPSS 12.0 program for Windows was used     to analyze the results.   "
139114|NCT01463826|"     The aim of the present study are to determine whether there is an association between     respiratory problems and dental caries in children who exhibit the habit of bruxism.   "
139115|NCT01463813|"     The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year     supplementation study of the benefits and risks of vitamin D in the primary prevention of     cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or     older.      [Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is     approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations]      The participants will be randomized to 3 groups with 6000 in each, with daily supplementation     of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of vitamin D3, or 3)     placebo.      [Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects per     group.]      Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD     and cancer risk factors will be assessed by questionnaires. Blood samples will be collected     for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future     ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record     linkage from the national computerized hospitalization registry.   "
139116|NCT01463800|"     Exercise intolerance is a major burden for patients with complex congenital heart disease     (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing     provides a reliable tool both for assessing exercise capacity of CHD patients and for risk     stratification and is becoming part of the routine clinical assessment of these patients.     Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise     training has been widely studied in chronic heart failure, its efficacy in adults with CHD     remain unknown. The investigators hypothesize that structured exercise training will improve     exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study     is to evaluate the impact of structured exercise training on exercise intolerance in patients     with complex CHD.   "
139149|NCT01463423|"     A research study using a method of treating lung cancer with focused radiation called     Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the     effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR     based on tumor-specific factors.   "
139117|NCT01463787|"     Varicocele is the most common surgical disease which could lead to male infertility. It is     found in approximately 15% adult males, and in about 40% infertile males. And the incidence     is up to 80% in secondary infertility. In the past, there was continuous controversy over     whether a varicocele repair could improve fertility. But at present, researches are coming to     a consensus on the indication of varicocelectomy. Several researches manifest that the     microsurgery of varicocele could have the effect of the highest spontaneous pregnancy and     lowest complications rate after surgery. Microsurgical varicocelectomy includes two     approaches, inguinal and subinguinal. Each one has its advantages and disadvantages. There     are few studies which make direct comparison between the two methods in microsurgical     varicocelectomy, especially in China. Operators have made decisions on the basis of their own     experience and skills. In this study, the investigators compare the postoperative spontaneous     pregnancy and complications rates in two approaches in microsurgical varicocelectomy for     Chinese infertile men in their hospital.   "
139118|NCT01463774|"     The purpose of this study is to evaluate the bioequivalence of a fixed dose combination     tablet of canagliflozin and metformin immediate release (IR) in comparison with the     individual components of canagliflozin and metformin IR.   "
139119|NCT01463761|"     Sports training aims to enhance an athlete's performance (overcompensation). To do that, the     athlete must go through periods of fatigue and lower performance (overreaching). When the     training plan is balanced, this fatigue is short and reversible.If the training load is too     heavy or if recuperation periods are too short, it can lead to persistence fatigue that may     only be reversible in the long term. This state of fatigue is part of the broader clinical     picture of overtraining, which includes stark changes in performance as well as mood and     sleep disorders. Many prediction and characterization methods based on biological markers     have been evaluated, but they have not been put into practice in sports training due to     obstacles such as reliability, interindividual variability and high costs. This study aims to     evaluate a new approach based on the variability of an individual's heart rate (RR     variability), which is a way of measuring autonomic nervous system (ASN) activity. It is     non-invasive, low-cost, and has already proven useful in athlete health monitoring.   "
139120|NCT01463748|"     Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. The purposes     of this study are going to investigate the effects of Graptopetalum paraguayense E. Walther     on the oxidative stress, antioxidant enzyme activity and inflammation in subjects with     metabolic syndromerelation. The investigators will recruit MS patients(n=50)and the inclusion     criteria of MS are according to the Bureau of Health Promotion, Department of Health in     Taiwan (2007). The MS subjects are randomly assigned to placebo(n=25) and Graptopetalum     paraguayense E. Walther supplements(n=25)groups. Hopefully, the results of this study could     provide the information of Graptopetalum paraguayense E. Walther supplements to what has been     know in MS subjects.   "
139145|NCT01463475|"     The objective of this protocol is to use established standard criteria and methods for the     collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The     hMSC collected from the donors will use to develop well-defined and reproducible cell banks.     Standard manufacturing procedures and quality control testing methods will be used to     characterize and evaluate the final cell product. After the cell banks are created, these     cell products will be used in future translational or clinical research.   "
139199|NCT01462695|"     This phase II trial studies how well sunitinib malate works in treating younger patients with     recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malate may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   "
139121|NCT01463735|"     Acanthocytes, also termed spur cell, are large erythrocytes covered with spike-like     projections which are associated with severe hemolytic anemia. In advanced cirrhosis,     acanthocytes may account for 20 to 30% of red blood cells. Up to 70% of cirrhotic patients     display anemia and hemoglobin level may fall to below 5 gr/L in spur cell anemia. The true     incidence of spur cells in cirrhosis is not known precisely but may avoisinate 45%, typically     in patients with advanced cirrhosis.The presence of spur cells usually predicts lower     survival rates. Vitamin E is an antioxidant compound that is a component of biological     membrane that helps to maintain integrity of lipid bilayers. Vitamin E deficiency leads to     erythrocyte hemolysis, which is improved by supplemental vitamin E. This study is an open     label single arm phase II study in cirrhotic patients treated for 4 weeks with Tocofersolan     (Vedrop), a water-soluble derivative of alpha-tocopherol, and thus an orally bio-available     source of vitamin E. The aim of this study is to determine the effect of tocofersolan on red     blood cell membranes lipid composition in adult patients with cirrhosis and vitamin E     deficiency. Secondary endpoints are the effects of tocofersolan on anemia, hemolysis and     acanthocytosis; on lipid peroxidation and oxidative stress; the safety of a 4 week treatment     of 700 mg/day.   "
139122|NCT01463722|"     The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body     Counting for Evaluating of Fetal Lung Maturity.   "
139123|NCT01463709|"     Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed     electric fields (nsPEF)   "
139124|NCT01463696|"     This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 and     its active metabolite (M16) in participants with advanced solid tumors. In Part 1 of the     study, the study drug dose will be escalated to determine the maximum tolerated dose (MTD).     In Part 2 of the study, the MTD will be confirmed and the recommended Phase 2 dose (RPTD)     established; the effect of MK-8242 on liposarcoma and other tumor types will also be     evaluated.   "
139125|NCT01463683|"     This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II     compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.   "
139126|NCT01463670|"     The purpose of this study is to determine whether this disease will get better if treated     with higher doses of Lenalidomide even if the disease returns while taking low doses of     Lenalidomide. In patients with multiple myeloma treated with Lenalidomide maintenance, the     disease will return. However, the physician currently does not know if the disease would     respond to treatment with higher doses of Lenalidomide. This is very important for patients     with multiple myeloma because the number of drugs available to treat the disease are limited.     It is important to know if Lenalidomide remains still effective and if it can still be used     in this situation. This study will try to find out what effects, good and/or bad higher doses     of Lenalidomide has on the patient and the disease after it has returned.   "
139128|NCT01463644|"     Some patients with chronic obstructive pulmonary diseases (COPD) have large number of     specific white blood cells called eosinophils in their airways. These cells are also     responsible for causing episodes of worsened respiratory symptoms (exacerbations) and often     cause irreversible damage to the airways . This subset of COPD patients often require oral     steroids to bring down the number of eosinophils in their airways. Steroids have harmful     effects on several of our body systems like bones, blood pressure, blood glucose control and     can cause recurrent infections. Mepolizumab is a drug that specifically targets eosinophils     reducing the number in the airway. This drug has been shown to be effective in decreasing     exacerbation rates and time to exacerbation in asthma patients with eosinophils in their     airways. Targeting eosinophils in COPD patients has been shown to reduce severe     exacerbations. Hence it is likely that COPD patients with eosinophils in their airways will     benefit similarly and have reduced rates and time to exacerbation.      Study Hypothesis:Does mepolizumab decrease sputum eosinophils in patients with fixed airflow     obstruction (COPD) and eosinophilic bronchitis?   "
139129|NCT01463631|"     This study evaluates the safety and tolerability of different doses of an experimental     treatment in participants with advanced cancer.   "
139130|NCT01462799|"     The hypothesis is that problem based learning (PBL) in patient education positively affects     self-care agency of lifestyle changes after an event of coronary heart disease (CHD). The     investigators therefore aim to determine whether long-term follow-up in primary health care     in patient education involving PBL affects self-care behaviour in terms of patients' beliefs,     self-efficacy and empowerment to make lifestyle changes. The general aim is to evaluate if     PBL in patient education after CHD affects long-term self-care in relation to present     lifestyle goals. Another aim of the study is to perform an economic assessment of long term     effects of life style changes reached by using PBL after en event of CHD.   "
139131|NCT01462786|"     The objectives of this trial are to evaluate the safety and tolerability of ATX-101     injections and to compare the pharmacokinetic profile of ATX-101 administered into     subcutaneous fat in the submental area and abdomen.   "
139132|NCT01462773|"     The purpose of this study is to determine the safety, tolerability and dose limiting     toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b     (IFN-α-2b) to patients with metastatic malignant melanoma.   "
139133|NCT01462760|"     In this study, the investigators will measure range of motion of the elbow in a geriatric     assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph     and the software analysis BioVal. This technique will be compared with the standard technique     (inclinometer). It will also be evaluated during this study, the ease of use and feedback.   "
139134|NCT01462747|"     The aim of this study is to evaluate the effects of rectally administered activated carbon     (medical device KULIST) in chronic, uncomplicated, perianal fistulas.   "
139200|NCT01462682|"     The aim of this study was to illustrate surgeons' own perception of fatigue and the impact     they felt it had on their performance. This was accomplished through a focus group study,     where 13 surgeons participated.   "
139579|NCT01457690|"     To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the     classical lipid-soluble form in a population of patients with intestinal malabsorption     (hypocholesterolemias family by retention of chylomicrons).   "
139136|NCT01463592|"     Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately     6-10% of the general public is expected to be suffering from this infection. In case that     these patients are not treated at an appropriate time, these patients develop the sequelae of     the chronic liver disease e.g. cirrhosis of liver, Ascites, and Hepatocellular carinoma.     Interferon alpha 2 a or alpha 2b injections and Ribavirin combination is the treatment of     choice for people suffering from Chronic HCV infection and this combination need to be     administered for 6-12 months. Interferons are biological agents and are to be administered     parenterally. Interferons are expensive and are associated with number of minor and major     adverse effects. Ribavirin is also associated with significant adverse effects. These     compounds cannot be considered as one of the ideal forms of the treatment.      In the past, quite a few natural products have been tested to assess their hepatoprotective     activity and possibly anti viral activity as well. These include Vitamin C (Ascorbic acid),     Vitamin E, Zinc, Silymarin, Red beet roots, crushed licorice and etc. etc.      Rationale Iodine , Potassium iodide and Ascorbic acid are natural products used in the     management of Thyroiditis and chronic cutaneous fungal infections. This combination of iodine     compounds along with ascorbic acid is being used for the management of chronic hepatitis B &     C in the central Asian states e.g. Kazakhstan etc.      The investigators have conducted a feasibility study in which oral Iodine Compound     {RENESSANS} was given to patients suffering HCV related Chronic Active Hepatitis and     anti-viral activity and safety has been analyzed. In this study, RENESSANS containing regimen     has been well tolerated by all the patients and has shown some antiviral activity.      In this study the investigators will assess whether the administration of RENESSANS {oral }     improves the antiviral activity in patients receiving standard interferon therapy.   "
139137|NCT01463579|"     The purpose of this study is to test if a 6-week programme of exercise improves physical     function and health related quality of life in patients following intensive care who are     discharged from hospital. In this study the investigators will compare the physical function     and health related quality of life of patients who attend the programme with patients who do     not. The 6 week exercise programme will be run by physiotherapy staff, and will mostly take     place in a hospital gym. The investigators will measure patients' physical function, exercise     capacity, level of breathlessness and their quality of life before and after the 6-week     programme, and 6 months later. The investigators will also interview patients to ask their     views about the acceptability, enjoyment and satisfaction with the exercise programme. If     this study shows that the physical function and health related quality of life are improved     in those who took part in the exercise programme, then it will provide useful information     which will help the development of services for patients after critical illness. The results     will also provide information which will help us design future clinical trials for this     patient population.   "
139138|NCT01463566|"     This is a prospective multicenter study of the Gender Solutions Natural Knee Flex System when     used in primary total knee arthroplasty. The purpose of the study is to obtain short-, Mid-,     and long-term clinical outcomes and implant survivorship data for the Gender Solutions     Natural Knee Flex System.   "
139165|NCT01463215|"     Ambroxol is expected to improve the signs and symptoms of patients with Type I Gaucher     Disease.   "
139166|NCT01463202|"     The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after     delivery to find out whether the timing of postpartum administration of DMPA (prior to     hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of     breastfeeding among women who plan to breastfeed their infants.   "
139139|NCT01463553|"     The purpose of this study is to:        1. Evaluate the validity of using abnormal characteristics of the pneumothorax line, as          evaluated from chest X-ray film, as the operative indications for video-assisted          thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).        2. Through a randomized double blind controlled trial on patients whose PSP was caused by          lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of          recurrence of PSP and the trauma of the operation on patients.        3. Based on the findings, establish selection standards for the timing of surgery to treat          PSP by VATS and establish technical specifications for performing operations on          different types of lung bullae. The goal is to improve the diagnosis and treatment of          PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation,          shorten hospital stays and postoperative recovery time, and provide better services for          returning to everyday life and improving the quality of life for patients.   "
139140|NCT01463540|"     Endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well     standardized technique. Two variants of this maneuver - the pull and the push techniques -     are widespread worldwide. More recently different techniques, that allow the direct insertion     of a gastrostomy tube has been described. The common characteristic shared by all these     technique is the fact that the gastrostomy tube is inserted directly into the stomach     (without passing through the pharynx), after the gastric and abdominal wall have been     securely fasten together (gastropexy).      Advantage of direct techniques are the followings:        1. the tube can placed also in the case of an oesophageal stenosis        2. studies suggest that the peristomal wound infection are less frequent using direct          techniques        3. in some variants of these techniques, a balloon type gastrostomy tube or a button can be          placed also in the case of first positioning. Both the balloon type tube and the button          are easy to be changed also at the bed-side.      Drawbacks of the direct techniques are:        1. these technique are easy, but a little more cumbersome than classic push or pull          maneuvers        2. operators are often not familiar with direct insertion        3. kits suited for direct insertion are generally more costly than available kits for push          or pull placement of gastrostomy tube.      The kit manufactured by the Kimberly-Clark (MIC Introducer kit) allows direct insertion of a     balloon type gastrostomy tube or of a button and it is interesting, because it makes simple     to perform the gastropexy.      The study aim is to confirm that the use of the Kit Introducer MIC, may allow safe placement     of a gastrostomy tube and may reduce the incidence of peristomal wound infection. Furthermore     if a balloon type gastrostomy tube or a button are positioned, they may be changed at the     bed-side, without referral of the patient to the endoscopic unit or to an other sanitary     facility.   "
139141|NCT01463527|"     The investigators hypothesize that the addition of capnography during moderate sedation will     improve recognition of hypoventilation and apnea. This will lead to an increased frequency of     staff interventions such as verbal or physical stimulation for these events in order to     improve ventilation which will in turn lead to a reduction in the frequency of oxygen     desaturations. If capnography proves to be effective in creating earlier detection and     intervention for hypoventilation and apnea during moderate sedation provided by     non-anesthesiologists, this device can be used in a variety of clinical settings to enhance     patient safety.   "
139142|NCT01463514|"     To study the effect of acute pulmonary vasodilatation on cerebral tissue oxygenation (CTO)     and cerebral blood flow (CBF) as indicator for cerebrovascular autoregulation in comparison     to the effects of supplemental oxygen, decreased carbon dioxide by hyperventilation and     exercise in patients with pulmonary hypertension (PH) undergoing clinically indicated right     heart catheterisation (RHC).      Oxygenation and hemodynamic parameters will be assessed during RHC according to standard     procedures. Non-invasive near infrared spectroscopy (NIRS) and a nasal canula will be     additionally applied to measure CTO, CBF and endtidal CO2 (EtCO2). All parameters will be     obtained at rest breathing room air, during an oxygen challenge, during standardized     hyperventilation, under vasodilatation testing and during exercise in random, single-blinded     sequences (except for exercise and hyperventilation). Pulmonary, systemic and cerebral     oxygenation parameters and hemodynamics will be correlated with each other and functional     class, quality of life, exercise and cognitive assessments at the time of the RHC and after     three month.   "
139143|NCT01463501|"     This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy     (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative     Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.   "
139146|NCT01463462|"     This is an observational, exploratory study designed to collect (record) and analyze normal     and abnormal sound data from the human bladder during surgery using a novel sensor-based     catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes     of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will     measure acoustic and pressure data within the bladder. The measurements will be used to     detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation     of sound data with surgical data reported by the surgeon. These data will be used to develop     algorithms to detect changes of baseline bladder and ureteral function. The algorithms will     be tested in future clinical trials.   "
139147|NCT01463449|"     CD163 is a membrane bound receptor primary expressed in monocytes and macrophages. A soluble     variant of CD163 (sCD163) is present in plasma and is elevated in pathological condition     activating the monocyte-macrophage system. Recently sCD163 is associated with various     inflammatory conditions, ex. adipose tissue inflammation and very recently to be a rather     strong predictor of the development of type 2-diabetes. Only a subset of obese individuals     develops insulin resistance, type 2-diabetes and related diseases. These healthy obese     subjects are characterized of less adipose tissue inflammation and less insulin resistance as     compared to unhealthy obese individuals. Consequently it would be of great importance to     develop markers that could discriminate between healthy and unhealthy obese subjects. Aim: To     investigate whether macrophage CD163 is involved in adipose tissue inflammation in obesity     and thereby to the metabolic complications of metabolic syndrome. To investigate how sCD163     is regulated by metabolic factors such as obesity, fat distribution, weight loss and diet.     Methods: Intervention study. 45 morbidly obese subject approved to gastric by-pass. Blood     samples, MR-spectroscopy, DXA, weight control and fat biopsy are taken before and 12 month     after surgery. Correlations studies: to investigate the influence of diet and weight loss on     CD163 and sCD163. Perspective: To study the role of macrophages infiltration and activation     for adipose tissue inflammation and to determine whether the macrophage marker, s-CD163,     together with other markers will be able better to identify obese individuals who are at     increased risk for developing complications such as diabetes   "
139148|NCT01463436|"     A randomized double blind controlled trial was conducted to evaluate the effect of daily     supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged     47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was     supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial     function.   "
139150|NCT01463410|"     This clinical study will demonstrate the accuracy of the chromosomal aberration and gene     mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical     performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug     Administration for in vitro diagnostic use within the United States of America.      The objective is to demonstrate the positive and negative percent agreement of each marker by     comparing AMLProfiler results from multiple clinical participating sites with data generated     using a laboratory developed bi-directional sequencing method generated at the molecular     diagnostic reference lab.      The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or     APL specific chromosomal aberrations (specific recurrent translocations and inversions), as     well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of     patients with Acute Myeloid Leukemia.   "
139151|NCT01463397|"     Primary Objective:      To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with     chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS).      Secondary Objectives:        -  To compare the effects of SAR292833 with placebo on the change of neuropathic pain          symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI);        -  To evaluate the effects of SAR292833 in comparison to placebo on the change in pain          intensity of mechanical allodynia;        -  To investigate the safety and tolerability of SAR292833 in comparison to placebo;        -  To investigate the pharmacokinetics (PK) and the relationships between main efficacy          parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in          patients with chronic peripheral neuropathic pain.   "
139152|NCT01463384|"     Cognitively normal individuals, patients with Mild Cognitive Impairment (MCI) or Alzheimer's     Disease (AD) will undergo clinical screening, neuropsychological tests, blood and urine     analyses, quantitative magnetic resonance imaging (MRI) and proton (1H ) and carbon 13 (13C)     magnetic resonance spectroscopy (MRS). Each individual will receive minocycline oral     administration for 4 weeks initially, after which MRI, MRS and neuropsychological results     will be recorded. If no adverse side effects occur, subjects will continue minocycline     administration for an additional 5 months.   "
139153|NCT01463371|"     The mechanism by which macrolide antibiotics have immune modifying effects independent from     its antibacterial activity has not been well established. In the present work, the     investigators will analyze the effect of long-term treatment with azithromycin (250 mg three     times per week during three months) on airway oxidative stress markers in exhaled breath     condensate of adult patients with stable non-CF bronchiectasis.   "
139154|NCT01463358|"     Study Objective      The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to     patient symptoms in patients with bifascicular block and syncope of unexplained origin.   "
139155|NCT01463345|"     The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based     transfusion triggers in patients post cardiac surgery.   "
139182|NCT01462994|"     Activating mutations of the kinases CKIT or PDGFRA can be detected in 90% of cases by DNA     sequence analysis of a pathological specimen. These mutated genomic DNA fragments are highly     specific for the tumor and are released by the tumor into the circulation. Allele-specific     PCR can be used to specifically amplify and quantify mutated CKIT and PDGFR DNA fragments.      The current trial aims to evaluate whether tumor DNA carrying mutations for CKIT and PDGFRA     can be detected and quantified in the plasma of patients with active GIST, and whether     detection can be correlated with the clinical course of disease either under therapy or in     progressive disease irrespective of current therapy.   "
139156|NCT01463332|"     Propofol is commonly used IV anesthetic, it has been formulated in a concentration of 10     mg/ml in a fat emulsion consisting of 10% soybean oil (long-chain triglycerides). When used     for anesthetic induction, propofol causes pain on injection in 28%-90% of patients. pain     probably results from a direct irritant effect. Several methods have been used to reduce this     pain. Lidocaine pretreatment has been commonly proposed to decrease propofol induced pain,     but its failure rate is between 13-32%. Dexmedetomidine is highly selective alfa-2     adrenoreceptor agonist. Alpha-2 receptors are located on blood vessels where they inhibit     norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could     attenuate the pain due to injection of propofol. Investigators conducted a study to determine     the efficacy of dexmedetomidine in decreasing pain due to injection of propofol.   "
139157|NCT01463319|"     Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no     incidence of drug-related side effects. May be slightly painful or discomforting for the     patient. Based on numerous recent reports, the investigators designed this randomized     controlled trial hypothesizing that the use of warm water irrigation versus air insufflation     during the insertion phase of colonoscopy might increase the global tolerability of the     examination and the proportion of patients undergoing complete colonoscopy without sedation     or with a low dose of sedatives.   "
139159|NCT01463293|"     This study will investigate the effects of 4-week probiotic supplementation on whole gut     transit time and gastrointestinal symptoms in adults with functional constipation.   "
139160|NCT01463280|"     The purpose of this study is to evaluate the effect of lidocaine, delivered into subcutaneous     tissue for tumescent local anesthesia, on platelet activation following the tumescent     liposuction.   "
139161|NCT01463267|"     This study is being done to look at how people manage their heart failure. The investigators     are testing two medication reminder systems and the investigators want to know which one     people like better. The investigators also want to see if they have any effect on ease of     managing medication in individuals with heart failure.   "
139162|NCT01463254|"     This will be a non-comparative prospective observational study of women using Femplant as a     primary method of contraception in Pakistan.   "
139163|NCT01463241|"     The overall objective of the project is to develop and assess the feasibility of a brief,     practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective     Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice     by practitioners in clinical service settings.   "
139164|NCT01463228|"     The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC)     tablet of canagliflozin and metformin immediate release (IR) in comparison with the     individual components of canagliflozin and metformin IR.   "
139167|NCT01463189|"     Development of an interactive, online pain self-management program for adults who suffer from     pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other     arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive     Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide     clinically reliable information about diagnosis, treatment, and management of arthritis,     written for health consumers in a clear and engaging manner to help increase their skills and     confidence to use self-management strategies.   "
139168|NCT01463176|"     Many young children undergo medical procedures that are painful and distressing. Negative     experiences during medical procedures can have serious long-term effects, including fear and     avoidance of medical procedures during adulthood. Distraction interventions can help prevent     children from forming negative memories of medical procedures. Live music therapy has been     shown to alleviate pediatric distress during both invasive and non-invasive procedures. The     objective of this study is to examine the effects of music therapy on the child's distress     behaviors and time to calm, as well as the length of the procedure and use of restraint, and     parents' and healthcare staffs' behaviors during the procedure, for young children undergoing     immunizations and influenza vaccinations. It is hypothesized that children receiving music     therapy will show fewer distress behaviors, calm more quickly, and have shorter procedures     with fewer instances of restraint compared to children who receive standard care. In     addition, it is predicted that adults (parents and staff) will show fewer distress-promoting     behaviors during, before, and after the procedures.   "
139169|NCT01463163|"     This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic     study with a parallel design. Patients with ST elevation myocardial infarction, undergoing     primary percutaneous coronary intervention will be randomized after informed consent, in a     1:1 ratio to the following treatment groups:      Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose     (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel     60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after     randomization).      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24     hours after randomization, and on Day 5. Documentation of major adverse cardiac events     (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and     serious adverse events (bleeding, other adverse events)will be performed until Day 5.   "
139194|NCT01462825|"     The purpose of this study is to determine the inhibiting effects of a single consumption of     tomato ketchup on inflammation which will be induced ex-vivo in human blood.   "
139170|NCT01463150|"     The use of dual antiplatelet therapy is considered standard of care in patients post     percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of     patients is considered clopidogrel resistant and this resistance is shown to be accompanied     by future adverse events. The aim of the study is to define in consecutive patients with     acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with     high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24     hours post PCI with the VerifyNow assay. Those patients will be randomized after informed     concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will     be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet     reactivity will be determined as well.   "
139171|NCT01463137|"     A study investigating six different versions of a computerized attention bias modification     internet program in the treatment of social phobia / social anxiety disorder.   "
139172|NCT01463124|"     Adolescent overweight and obesity have increased dramatically in the past several decades.     High schools are well-positioned to deliver weight loss treatment to overweight and obese     adolescents, as they have the facilities and staff to deliver a physical activity program,     school nurses with the skills to provide counseling, and are easily accessible by     adolescents. This exploratory study will test the feasibility and ability of a school-based     intervention, consisting of school nurse counseling and a school-based exercise program, to     reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in     overweight and obese adolescents. If effective, this could prove to be a cost-effective and     relatively easy intervention to disseminate widely for significant public health impact.   "
139173|NCT01463111|"     Forty subjects with bipolar disorder who are not receiving a mood-stabilizing medication for     the treatment of their illness will participate in this study. The study aims to evaluate how     decision-making is affected by treatment for bipolar disorder. Prior to beginning treatment,     patients will complete questionnaires and a one-hour computer-administered assessment of     decision-making. Differences between pre-post decision-making outcomes will be evaluated to     examine whether the neuroeconomic concepts of risk aversion, loss aversion, risk tolerance     and delay discounting are affected by treatment.      The overall goal of this study will be to identify whether decision-making in people with     bipolar disorder is affected by treatment. Specifically the investigators will compare     decision-making characteristics among bipolar patients prior to treatment with how these     decision-making characteristics change over the course of 6 weeks of standard medication     therapy for bipolar disorder. A total of 6 decision-making tasks and one control task will be     administered via computer to eligible subjects. The investigators will evaluate     decision-making under varying conditions of reward, risk, and uncertainty and over time. The     investigators hypothesize that decision-making will improve across these assessments after 6     weeks of treatment.   "
139174|NCT01463098|"     Part A: The purpose of this study is to evaluate the safety and tolerability of single oral     doses of E2006 administered in the morning to healthy male and female subjects.      Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters     (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects     with primary insomnia following single oral dosing of E2006 in the evening approximately 30     minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.   "
139175|NCT01463085|"     The purpose of this study is to determine if increased consumption of low-fat dairy can     reduce blood pressure and improve endothelial function in men and women with pre or stage-1     hypertension.   "
140522|NCT01445262|"     This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data     among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation,     prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets before.   "
139176|NCT01463072|"     This phase II trial studies the side effects of paclitaxel albumin-stabilized nanoparticle     formulation in treating older patients with breast cancer that has spread from where it     started to nearby tissue or lymph nodes (locally advanced) or other places in the body     (metastatic). Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle     formulation, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing, or by stopping them from spreading.   "
139177|NCT01463059|"     The primary objective of this study is to evaluate the efficacy and safety of CDP6038     administered subcutaneous (sc) at various doses compared to placebo.   "
139178|NCT01463046|"     The purpose of this study is to see if Panobinostat is safe to give to patients and to     determine the best dose to give in combination with standard cytarabine and daunorubicin     chemotherapy.   "
139179|NCT01463033|"     Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at     preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful.     Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of     epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a     strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury     (TBI). However, there has been no experience in administering levetiracetam rapidly to     individuals with acute TBI. The investigators propose to initiate the evaluation of     levetiracetam in prevention of post-traumatic epilepsy by determining the safety,     tolerability, pharmacokinetics and feasibility of acute and chronic administration of     levetiracetam to individuals with head injury with a high risk for developing post-traumatic     epilepsy. Further, the investigators will follow subjects for 2 years after injury in order     to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first step     in evaluation of levetiracetam in prevention of post-traumatic epilepsy.   "
139180|NCT01463020|"     The objective is to test the effects of a smartphone-delivered behavioural activation     treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be     made. We expect the behavioural activation intervention to be superior to the mindfulness     intervention for the participants suffering from high severity of depressive symptoms - and     the mindfulness intervention to be better or at least as good as the behavioural activation     intervention for the participants suffering from low severity of depressive symptoms.   "
139181|NCT01463007|"     The purpose of this study is to evaluate the rate of early and intermediate toxicity related     to the AccuBoost System for delivery of APBI in women with resected, early stage breast     cancer.   "
139195|NCT01462812|"     The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through     the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated     with migraine headaches.   "
139183|NCT01462981|"     Hepatitis B is a form of liver disease caused by a DNA-virus, called hepatitis B virus (HBV).     Infection can result in an inflammation of the liver parenchyma with various clinical     manifestations ranging from an asymptomatic course to jaundice. After contact with the virus     the immunological response of the host determines the clinical outcome leading to either     viral clearance or a chronic infection.      Although several factors are responsible for the development of chronic HBV-infection, one of     the factors is a weak and transient CD8+ T-cell responses after HBV infection. In chronic     hepatitis B, inflammation can lead to scarring which is the driving force to fibrosis and     cirrhosis. Some immunological parameters, like a newly discovered subset of IL-17 producing T     helper cells (Th17 cells), may influence the disease progression of HBV. In the cirrhotic     patient, eventually there is an increased risk of hepatocellular carcinoma (HCC) leading to     liver failure.      Recent literature in Asian patients with chronic hepatitis B showed that serum HBV viral load     is a strong predictor for the development of cirrhosis, independent of hepatitis B e- antigen     status and serum alanine transaminase level. It is unclear whether these results can be     extrapolated to non-Asian (Caucasian and African) populations because of differences in host     (HLA background) and viral (HBV genotype) factors.      The aim of this study is to elucidate the question whether historic HBV viral load is     associated with the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian     individuals with chronic hepatitis B infection.   "
139184|NCT01462968|"     The purpose of this study is to find the heparinization method, which        1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis        2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared          to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac          surgery.      The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in     the Hepcon-group because of the heparinization-method. Therefore there is a potential higher     risk for use of bloodproducts postoperatively.   "
139185|NCT01462942|"     The objective is to provide data supporting the use of LAS40464 as an efficacious and safe     maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease     (COPD).   "
139186|NCT01462929|"     The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled     aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide,     respectively, after 6 weeks of treatment.   "
139187|NCT01462916|"     Based on the assumption that honey may have an immunomodulatory effect, the aim of our     present study will be to verify whether the intake of honey, as a natural substance, in     patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and     hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be     recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University,     Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated thrombocytopenia     with a peripheral blood platelet count less than 100 x 109/L, and absence of any obvious     initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is defined as ITP for     at least 12 months. The age of the patients will range from 5 to 15 years, and they will be     of both sexes. This study was approved by the local Ethics Committee of the Pediatric     Department of Ain Shams University, and an informed consent to participate in this study will     be obtained from at least one parent of each patient. Furthermore, an ascent form will be     obtained from each patient above 7 years of age.   "
146362|NCT01368536|"     This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and     chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and     diabetes mellitus 2.   "
139188|NCT01462903|"     Background: T cell based adoptive immunotherapy including CTL and TIL may stimulated the     immune system and stop cancer cells from growing.      Objective: Phase I clinical trial to investigate the toxicity and immune response of therapy     with autologous tumor infiltrating lymphocytes as adjuvant treatment for metastatic     nasopharyngeal carcinoma and hepatocellular carcinoma after primary operation, radiotherapy     and chemotherapy.      Methodology: Phase I clinical trial in patients with advanced nasopharyngeal carcinoma,     hepatocellular carcinoma, breast cancer and other solid cancers. The investigators isolated     lymphocytes from fresh tumor tissues, activated and expanded TILs in vitro; and infused the     enough number (10e9 to 10e10) of TIL back patients.   "
139189|NCT01462890|"     The purpose of this study is to determine whether the early and continuous addition of     bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early     and continuous addition of bevacizumab for up to 15 months.   "
139190|NCT01462877|"     Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk     equivalents, whose TG level is not adequately controlled after statin monotherapy. According     to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient     who has insufficient improvement. The purpose of the study is to evaluate the efficacy on     lipid control and the safety of adding fenofibrate in patients on a background of statin     treatment.   "
139191|NCT01462864|"     Polycystic Ovary syndrome (PCOS) is a common hormonal imbalance affecting about 12% of women     in the UK. The number of women with PCOS is rising. They suffer from a combination of     symptoms including excess hair, irregular/absent periods, and infertility. About 70% of women     with PCOS are obese or overweight, 10% develop type 2 diabetes (T2DM), and 30-40% have some     degrees of abnormality in controlling (metabolising) blood sugar. Studies have shown that if     women with PCOS make change to their lifestyle (diet and activity), they may reduce their     risk of getting diabetes and heart disease in the future. This study aims to develop and test     a programme that can be run in groups (structured education), to support women with PCOS make     the lifestyle changes needed to improve their PCOS and prevent future associated health     problems. Structured education programmes are suitable for use within the NHS and are already     recommended for individuals with T2DM, but have not been tested as a method of treatment for     PCOS which is a high risk condition for T2DM.      The investigators aim to initially develop a specific education programme for women with PCOS     using their expertise in their disease and defining their needs. The next step is to test     this programme on 160 women with PCOS who will be selected from the investigators database or     clinics. They will be divided randomly to two groups to receive either this programme or     routine care.      The investigators will give them an accelerometer (a very small portable device). This will     measure their physical activity and counts their daily steps. The investigators aim is to     increase their step count by at least 2000 steps per day after one year.      The investigators believe that the group given the structured education will show some     evidence of improvement in their glucose metabolism, and consequently decreased chance of     developing diabetes.   "
139192|NCT01462851|"     This study is designed to observe the safety and concentrations of PF-05297909 and proteins     in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.   "
139193|NCT01462838|"     Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16_37-63     in combination with Montanide® ISA-51 VG so that an immune response directed against the     tumor cells can be induced. The aim is to show that vaccination with P16_37-63 is safe and     can induce or enhance immune responses against p16INK4a.   "
139201|NCT01462669|"     The purpose of this study is to investigate the pharmacokinetics of single oral doses of     ezogabine/retigabine and the primary metabolite (NAMR) in healthy male and female Taiwanese     volunteers. Subjects will receive four separate doses of ezogabine/retigabine tablets: 50 mg,     100 mg, 200 mg and 400 mg administered once orally. Blood samples will be obtained at     pre-defined timepoints over the duration of the study to determine the concentration of     ezogabine/retigabine and NAMR. Safety assessments will include measurements of vital signs,     collection of adverse events, clinical laboratory tests and the Columbia Suicide Severity     Rating Scale.   "
139202|NCT01462656|"     A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients     within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the     launch of Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be followed     until the earliest of an episode of urinary retention (UR), change in their AED regimen, end     of follow-up, or end of study (when the specified sample size of EZG AED polytherapy users     has been attained). After the end of study, the incidence of UR during exposures to EZG and     non-EZG AED polytherapies will be compared. Polytherapy will be defined as treatment regimen     containing at least two different AEDs.      A prospective cohort study of patients who receive EZG under circumstances not indicated in     the product label within the HIRD will also be conducted. Following the launch of EZG,     epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients     initiating EZG for another disease will be followed until the earliest of an episode of UR,     change in their AED regimen (if applicable), end of follow-up, or end of study. The incidence     of UR during exposure to EZG under circumstances not indicated in the product label will be     described. A descriptive analysis of the patients will also be included.      To meet the other secondary objective, non-EZG AED monotherapy users will be identified in     the prospective cohort and incidence of UR will be calculated to determine if there is a     difference in UR risk between monotherapy and polytherapy AED use.   "
139203|NCT01462643|"     The aim of the exploratory study is to compare dose related effects of LAS41004 formulations     in a non-occlusive PPT.   "
139204|NCT01462630|"     This phase II trial studies how well pazopanib hydrochloride works in treating patients with     advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth.   "
139205|NCT01462617|"     The study will comprise three Parts:      Part A will consist of two cohorts of healthy male volunteers to assess the safety,     tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557. Blinded     safety and available PK data will be reviewed before each dose escalation.      Part B will be one cohort to examine the safety, tolerability and pharmacokinetics of a     repeated dose of GSK2269557 given by nebuliser for 7 days in healthy male volunteers. The     total daily dose will be the same as, or lower than, doses that are well tolerated in Part A.      Part C will consist of two cohorts of single nebulised doses in healthy male smokers, to     assess pharmacodynamic endpoints in sputum and bronchoalveolar lavage.   "
139206|NCT01462604|"     This is a 6-week, single arm, pilot study to test the study procedure, educational materials,     and measurement instruments for the educational intervention in HER2 overexpressing     metastatic or advanced breast cancer patients   "
139207|NCT01462591|"     Cardiovascular disease (CVD) is considered the primary cause of death in the developed world.     Large scale epidemiological studies indicate that prevalence of hypertension along with     adverse cardiovascular events peak during the winter months. Moreover, during the winter     months outdoor activities and physical stressors such as exercise have been associated with     higher cardiovascular mortality when compared to other periods of the year. Although low     environmental temperatures have been implicated as the triggering factor for cardiovascular     complications, the mechanisms on how cold exposure increase cardiovascular morbidity and     mortality remain to be elucidated. However, new research suggests that cold exposure may     induce increases in cardiac sympathetic activity, endothelial damage and increased arterial     stiffness of central arteries. Cardiovascular drugs including antihypertensive     pharmacological agents seem to be inefficient to provide appropriate therapeutic effects     during cold exposure. Therefore, it is imperative to propose alternative non-pharmacological     therapies intended to prevent the detrimental effects of low environmental temperatures on     cardiovascular function. Recently, oral supplementation of the amino acid L-citrulline has     been proposed as an effective therapeutic adjuvant for the treatment of hypertension.     L-citrulline is known to enhance the bioavailability of L-arginine levels and increase     endothelial nitric oxide (NO) production, one of the main modulators of vascular tone and     blood pressure (BP). L-citrulline supplementation has been shown to increase endothelial     function, reduce BP, and ameliorate endothelial oxidative damage without any adverse effects.     Our group has demonstrated that L-citrulline supplementation attenuates the BP response to     cold exposure (the cold pressor test, CPT). These studies suggest that L-citrulline     supplementation may be a feasible therapeutic aid in order to prevent cardiovascular     complications associated with cold exposure. However the potential cardioprotective effects     of L-citrulline supplementation during cold exposure with exercise have yet to be evaluated.     It is hypothesized that L-citrulline supplementation would reduce arterial stiffness and     blood pressure (BP) responses to physiological stress (cold exposure). This study may lead to     the development of an adjunct therapy for the prevention and management of cardiovascular     adverse events that are particularly increased during the winter months.   "
139208|NCT01462578|"     Assessment of efficacy of azacitidine to prevent a relapse   "
139209|NCT01462565|"     The purpose of this multicentre, open label, single-arm study in approximately 20 adult     patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of     epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).   "
139210|NCT01462552|"     In July 2008, the lapatinib (Tykerb) Prescribing Information (label) was updated to include a     boxed warning related to hepatotoxcity and detailed instructions for monitoring liver     function before and during lapatanib exposure. For patient safety, it is of interest to know     the extent to which providers are adherent with these guidelines for hepatic monitoring of     lapatanib users.      Thus, the aim of this study is to determine if physicians conduct liver function testing     prior to prescribing lapatanib and at regular intervals during exposure, and if they withdraw     lapatanib, and do not re-treat, for patients who demonstrate severe liver enzyme elevations     while exposed. These aims will be tested in the Pre-label (prior to the boxed warning) and     Post-label (after the boxed warning) periods to determine if physician adherence to the     guidelines changed as a result of the warning.      Specifically, the boxed warning provided the following guidance:      Hepatotoxicity (alanine transaminase or aspartate transaminase >3 times the upper limit of     normal and total bilirubin >1.5 times the upper limit of normal) has been observed in     clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be     severe and deaths have been reported. Causality of the deaths is uncertain. The     hepatotoxicity may occur days to several months after initiation of treatment. Liver function     tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before     initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If     changes in liver function are severe, therapy with lapatanib should be discontinued and     patients should not be re-treated with lapatanib      The following objectives will be assessed and compared among patients prescribed lapatanib     before and after the addition of detailed guidance on liver function testing to the product     label on July 9, 2008:        1. Objective 1: Determine if physicians perform liver funtion tests (LFTs) prior to          prescribing lapatanib (baseline)        2. Objective 2: Describe the prevalence of LFT elevations at baseline        3. Objective 3: Determine if physicians routinely perform LFTs during the duration of          lapatanib exposure        4. Objective 4: Describe the cumulative incidence and incidence rate of LFT elevations          during lapatanib exposure        5. Objective 5: Describe patients that experience severe LFT elevations during lapatanib          exposure and calculate the proportion that have lapatanib discontinued and are not          re-treated      To achieve these objectives, an observational retrospective cohort study will be conducted     using the United States Oncology Electronic Medical Records database. The study population     will consist of females with a diagnosis of metastatic breast cancer and a documented order     for Lapatanib from January 1, 2007 - December 31, 2009. Patients will be categorized by     whether they initiated Lapatanib before or after the July 9, 2008 label change.      'Pre Label': Initiated lapatanib between January 1, 2007 and December 31, 2007. Follow-up     time for this group will continue until June 30, 2008 to allow these patients to have at     least six months of follow-up time prior to the label change.      'Post Label': Initiated lapatanib between July 9, 2008 and December 31, 2009. Follow-up time     for this group will continue until June 30, 2010 to allow these patients to have at least six     month of follow-up.      The exposure in this study is lapatanib oral medication. The date of initiation of lapatanib     will be the index date. Lapatanib exposure period(s) will be defined from the index date     through to the end of the study period (June 30, 2008 for pre-label group or June 30, 2010     for post-label group).      The project will use proportions and two estimates of incidence (cumulative incidence and     incidence rates using person-time) to describe the outcomes of interest among the users of     Lapatanib before and after the label change. The following LFTs will be considered:        -  alanine transaminase (ALT)        -  aspartate transaminase (AST)        -  alkaline phosphatise (ALP)   "
139211|NCT01462539|"     Adenotonsillectomies are one of the most common childhood surgeries and are first-line     treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study     comparing patients with and without OSA looking at the length of stay following     adenotonsillectomy and the factors affecting length of stay.   "
139212|NCT01462526|"     Current screening methods for glaucoma detection are not perfect and nearly half of those in     the United States with glaucoma go undiagnosed. Minority populations are even less likely to     be diagnosed. Better screening methods are needed to identify the undiagnosed and to provide     them care that can help them retain good vision.      Glaucoma is often more severe in one eye and this fact can be exploited in screening tests.     The investigators plan to use a novel screening device that very accurately records the     pupillary response from each eye. It is likely that patients with glaucoma will have abnormal     responses when measured, and by comparing responses between the two eyes the investigators     will be able to determine who has glaucoma. If this test works well, it will provide a     low-cost way to screen populations at risk for glaucoma. Furthermore, this research will     expand the knowledge base regarding how pupil responses to light differ between persons with     and without glaucoma. Insights gained from this study will be useful in the development of an     effective screening tool in the detection of glaucoma.   "
139213|NCT01462513|"     Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival     (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and     saline infusion).   "
139214|NCT01462500|"     The purpose of this study is to determine the pharmacokinetics of miltefosine in children and     adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with the     parasitologic response. The results will provide pharmacologic bases to optimize the use of     miltefosine for the treatment of cutaneous leishmaniasis, and will provide the knowledge base     to assess the impact of pharmacokinetic behavior in children and adults on the emergence of     drug resistance.   "
139215|NCT01462487|"     Zanamivir is a neuraminidase inhibitor that has demonstrated effectiveness against the     pandemic H1N1 virus. Zanamivir was first authorized in Sweden in June 1999 and is approved in     the European Union (EU) through mutual recognition. It is indicated for treatment and     prevention of influenza in adults and children over the age of 5 years.      Zanamivir animal studies, conducted primarily in rabbits, showed a trend towards increased     post-implantation loss, decreased fetal body weight, and increased minor fetal skeletal     changes, although these effects were not statistically significant. Given the frequency,     pattern and distribution of these effects, it was concluded that they were not related to     zanamivir treatment. The summary of product characteristics for zanamivir states that it     should not be used during pregnancy unless the potential benefit to the mother justifies the     risk to the fetus.      Postmarketing data have shown no higher risk of malformation with oseltamivir than in the     general population, but data on zanamivir are scarcer. Limited data are available on     pregnancy outcomes with maternal exposure to zanamivir during pregnancy. From 01 August 2003     through 31 January 2009, 133 women were reported to have been treated with zanamivir while     pregnant. Of these 133 pregnancies, 83 pregnancies were on-going or had been lost to     follow-up (62.4%) at the time of the report; 43 resulted in a live birth with no apparent     congenital anomalies (32.3%), 4 represented spontaneous abortions with no apparent congenital     anomalies (3.0%), 2 were elective terminations with no apparent congenital anomalies (1.5%),     and 1 was an ectopic pregnancy (<1%). The European Medicines Agency (EMA) has concluded that     exposure to zanamivir during pregnancy does not represent a new safety risk to the fetus.      Published research has suggested that early antiviral treatment of pregnant H1N1 patients can     improve outcomes. In a Center for Disease Control and Prevention (CDC) surveillance     population of 788 pregnant influenza patients with disease onset between April and August     2009, the 384 with data on timing of antiviral treatment were observed to have significantly     higher risk of adverse outcomes with later treatment ('intermediate', i.e. 3-4 days, n=84;     'late', i.e. > 4 days: n=81) than with early treatment (< 2 days: n=219). Compared with those     given early treatment, those given intermediate treatment had almost 10 times the risk of     death, and those given late treatment, more than 50 times. Intensive Care Unit (ICU)     admission showed more than a 2-fold risk elevation with intermediate treatment and a six-fold     elevation with late treatment, Respective elevations in risk of need for mechanical     ventilation were almost 4-fold and more than 12-fold. The authors noted that the reason for     treatment delays in this population are unknown, but could include reluctance on the part of     clinicians and patients to expose the fetus to antiviral medications, as well as use of rapid     influenza tests, which have shown low (10%-70%) sensitivity for H1N1.      As part of their ongoing epidemiologic safety monitoring initiatives requested by the EMA     during the influenza pandemic of 2009-2010, GSK seeks to conduct a pregnancy safety study to     better understand the safety of zanamivir in women exposed during pregnancy for either the     treatment or prevention of influenza. This safety study will collect information from     existing European databases with records of pregnant women exposed to these products and     their pregnancy outcomes in order to assess the safety of these treatments in this     population.      GSK is working with PPD as the contract research organization (CRO) to oversee conduct of     this study, including data source management and payment, study design input, epidemiological     advice, data transfer oversight and overall project management. The CRO will keep a record of     all relevant personnel involved in the study. Additionally, PPD has a strategic alliance with     World Health Information Science Consultants, LLC (WHISCON) (www.whiscon.com), an     internationally recognized organization conducting post-approval drug safety and risk     management epidemiology. WHISCON will be providing services related to protocol development     as well as database-specific work plans, and will assist in analysis and interpretation of     data.      The primary objective of this study is to evaluate the safety of zanamivir taken during     pregnancy on 1) the outcome of the pregnancy, 2) congenital anomalies identifiable at or     shortly after birth, and 3) treatment-emergent diagnoses in the mother occurring within 28     days of receipt of zanamivir.      The secondary objectives of this study are 1) to develop techniques for identifying     influenza-like illness (ILI) in the participating data sources, and 2) to identify the     characteristics of zanamivir recipients.   "
139216|NCT01462474|"     RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,     Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is     manageable.      PURPOSE: This phase I trial is studying the safety and tolerance of concurrent     chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.   "
139217|NCT01462461|"     The purpose of this study is to determine if observing a virtual arm decreases phantom limb     pain (PLP) in upper extremity amputees.   "
139218|NCT01462448|"     The purpose of this study is to determine if there is a genetic component to phantom limb     pain. DNA will be analyzed for single nucleotide polymorphisms (SNPs) between the control and     phantom limb pain group. Total RNA will also be isolated and profiled to asses the degree to     which our gene(s) of interest are expressed in the presence or absence of phantom limb pain.     Some proteins, such as inflammatory antibodies or the neurotrophin brain-derived neurotrophic     factor (BDNF), will also be assessed for their association(s) with phantom limb pain.   "
139219|NCT01462435|"     The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and     effective for the treatment of bunionectomy pain.   "
139220|NCT01462422|"     This study compares two community-level strategies: selective administration of 800 mcg     sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum     hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for     primary prevention of PPH. The study hypothesizes that at community-level births, secondary     prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis     provided to women for primary prevention of PPH. This cluster-design non-inferiority trial     has the potential to inform service delivery programs on clinical outcomes, program     feasibility, cost and acceptability of two different community models of PPH care using     misoprostol.   "
139221|NCT01462409|"     Heated humidification in CPAP therapy is often not enough to prevent side effects like     dryness of nasal mucosa and xerostomia, especially in cases of mouth breathing or mask     leakage. Additionally a higher level of humidification in lower ambient room temperature can     lead to condensation and irritating noises. Compliance of affected patients decreases     considerably. Regarding this, devices with humidifier and additional heated tubing are     developed to automatically regulate optimal humidification and temperature right up to the     mask. The efficacy of a system with controlled heated humidification and heated tubing in     nasal masks under various conditions like leakage and different pressure levels is object of     this study.   "
140751|NCT01442181|"     The purpose of this study is to compare a minimally invasive surgical procedure and     medication management in stroke patients with Atrial Fibrillation. The two treatment options     are a minimally invasive surgical procedure or the use of medications.   "
139222|NCT01462396|"     Allogeneic stem cell transplantation has been explored for patients with high risk     neuroblastoma. Results have been mixed, with only small series and case reports. Recent     reports, however, especially with haploidentical transplantation have been more encouraging.     Eradication of neuroblastoma may be mediated by both components of the innate immune system     (natural killer cells) and through the adaptive immune system via T-cell cytotoxicity and the     development of a humoral response to tumor specific antigens and minor histocompatibility     antigens. To overcome restrictions created by unavailability of Human leukocyte antigen (HLA)     matched donors, stem cell grafts from haploidentical related donors have been explored.     Historically, the use of full haplotype mismatched family member donors has been limited by     the development of severe graft-versus-host disease and the high rate of graft failure. Graft     failure can now be overcome by increasing immunosuppression and increasing the number of     transplanted stem cells. The most effective means of graft versus host disease (GVHD)     prophylaxis is T cell depletion of the donor marrow. A 3-4 log depletion will reduce the risk     of developing significant GVHD to less than 10%. Methods to mobilize stem cells from the bone     marrow into the peripheral blood and collect these stem cells by apheresis now increase the     availability of stem cells by a magnitude. Selection devices have been developed that will     prepare extremely pure populations of these CD34 cells with upwards of 5 logs depletion of     contaminating T cells. The CliniMACS CD34 Reagent System is a medical device designed to     select CD34+ hematopoietic cells from heterogeneous hematologic cell populations. The     investigators intend to provide mismatched related hematopoietic stem cell transplantation to     up to 10 patients with relapsed refractory neuroblastoma. Harnessing the potential for innate     and adaptive immune responses through allogeneic Hematopoietic stem cell transplantation     (HSCT) may provide cure for some patients with this tumor.   "
139223|NCT01462383|"     Primary Objective:      -Evaluate incidence of cardiac complications in Phase I patients.      Secondary Objective:      -To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the     detection of cardiac events.   "
139224|NCT01462370|"     This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib     compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.   "
139225|NCT01462357|"     The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix     administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered     according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6     months in 9-14 years old healthy females.   "
139226|NCT01462344|"     The purpose of this study is to assess whether the risk of serious asthma-related events     (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11     years old taking inhaled fluticasone propionate/salmeterol combination is the same as those     taking inhaled fluticasone propionate alone.   "
139227|NCT01462331|"     The purpose of this study is to re-confirm the already established health effects and dose     tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food     ingredient.   "
139228|NCT01462318|"     The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield     Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the     pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS).     The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC     HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of     participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for     cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).   "
139229|NCT01462305|"     The primary objective of this study is to evaluate the effect of light therapy using a narrow     467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It     is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm     light.   "
139230|NCT01462292|"     The purpose of this study is to determine if GSK2402968 is effective in the treatment of     ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be     corrected by exon 51 skipping. Two doses of GSK2402968 and placebo will be used in this     study.   "
139231|NCT01462279|"     The objective of this study is to determine the effect of thiamine therapy on oxygen     consumption in critically-ill patients. The investigators will evaluate this by measuring VO2     before and after thiamine administration in patients admitted to the ICU and requiring     mechanical ventilation.   "
139232|NCT01462266|"     The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg     once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus     who have inadequate glycemic control on insulin alone or in combination with metformin. The     primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of     insulin relative to placebo.   "
139233|NCT01462253|"     This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide     combination to treat refractory and first bone marrow relapse adult ALL, for the achievement     of a complete remission (CR) and the concurrent evaluation of biological response in ALL     cells (minimal residual disease, apoptosis and DNA cell damage, pharmacogenomics).   "
139234|NCT01462240|"     This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used     in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and     long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous     Femoral components.   "
139235|NCT01462227|"     Insulin treatment often causes the blood glucose levels to fall too low. The body usually     responds to low blood glucose levels by releasing hormones which act against the insulin to     help correct the low blood glucose levels. However, this hormone response can be altered in     people with diabetes. Currently there are no therapeutic agents that can be used to improve     the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people     who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it     can also affect the levels of the hormones which are released during hypoglycemia. The aim of     this study is to determine whether naltrexone can be used to improve and accelerate the     recovery from hypoglycemia in patients with type 1 diabetes.   "
139249|NCT01462032|"     This study is designed to evaluate two potential treatments for children with     Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication.     Our goal is to develop new interventions for preschoolers with ADHD that will result in     enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent     long-term difficulties characteristic of many children with ADHD.      Both interventions involve weekly playgroups (of roughly five children) in which children     engage in designated activities while parents engage in groups focusing on parent education,     support, and their children's activities. It is hypothesized that both interventions will be     helpful, but that only one will have lasting effects well beyond the end of active treatment.   "
140764|NCT01442012|"     To evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting     (PONV) in Ambulatory Surgery.   "
139236|NCT01462214|"     In the present phase 1-2 study the investigators aim to determine whether depletion of Tregs     using metronomic cyclophosphamide can enhance the antitumor efficacy of everolimus in     patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase     inhibitor containing treatment regimen. In the phase 1 part of the study the investigators     will determine the optimal CD4+CD25+ regulatory T cell-depleting dose and schedule of     metronomic oral cyclophosphamide when given in combination with a fixed dose (10 mg daily) of     everolimus. In the phase 2 part of the study the investigators will subsequently evaluate     whether the number of patients who are cancer progression free at 4 months can be increased     from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in     the phase 1 part) to everolimus. In addition to efficacy, the investigators will evaluate     treatment toxicity to determine whether this combination strategy is feasible and safe.   "
139237|NCT01462201|"     The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1     System on abdominal midsection circumference reduction relative to no treatment.      The secondary objective of this study is to assess subject satisfaction measured with a     self-assessment questionnaire   "
139238|NCT01462188|"     The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely     thrombotic lesion may determine distal embolisation of thrombotic material therefore     deteriorating myocardial perfusion.   "
139239|NCT01462175|"     This multicenter, open label, dose-escalating study will evaluate the safety,     pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD)     or once weekly (QW) in participants with advanced malignancies except leukemia. Participants     will receive multiple escalating oral doses in two different dosing schedules (Sch) until     disease progression or unacceptable toxicity occurs.   "
139240|NCT01462162|"     This prospective observational study will investigate the effect of tocilizumab on fatigue in     participants with moderate to severe rheumatoid arthritis who have an inadequate response to     disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data     will be collected from participants for 6 months.   "
139241|NCT01462149|"     Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to     treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected     chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic     efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However,     docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate     the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with     advanced ovarian cancer.   "
139242|NCT01462136|"     The purposes of this study is to assess the relationship between renal function and     pharmacokinetics of ACHN-490 Injection.   "
139243|NCT01462123|"     Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and     pathologic data. Real-time imaging technologies, have shown promising results in     discriminating adenomatous from non-adenomatous polyps.      The resect and discard strategy for small polyps (based on real-time assessment of the     histology and on the endoscopic resection without pathological examination) has been shown to     be cost-effective in simulation models. No data exist about the impact of this strategy in     clinical practice.      The aim of present study was to assess whether the systematic use, in the everyday clinical     practice, of the resect and discard strategy allows to correctly manage patients with small     colonic polyps.   "
139244|NCT01462097|"     Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated     with impairment in cognition and physical function. The purpose of this study is to test the     effects of 12 months of aerobic and resistance exercise training compared to health education     on cognitive and physical performance in 120 older adults with CKD not requiring dialysis.     The results of this study will be essential for demonstrating the effectiveness of exercise     in improving function and ultimately preventing disability in this high-risk population of     older adults.   "
139245|NCT01462084|"     Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive     servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA)     complicated by central sleep apnea (CSA) due to the chronic use of opioid medications   "
139246|NCT01462071|"     Background:      A low amount of red blood cells in the blood of patients with limited kidney function is a     well known problem. Besides the lack of substances in the blood like iron or erythropoietin     the shortened survival of red blood cells leads to the low red blood cell count. Red blood     cells of patients on kidney replacement therapy (dialysis) die earlier than those of healthy     persons. They live only about 70 days compared to 120 days in healthy humans. Today little is     known about the causes for the shorter survival of the red blood cells in patients on     dialysis. Because inflammation leads to a shorter life of the red blood cells in people     suffering from several diseases leading to inflammation we would like to learn about the role     of inflammation in the shortened life of red blood cells of dialysis patients.      When red blood cells are dying the content is broken down to several substances. One of these     substances is the gas carbon monoxide (CO). The carbon monoxide is exhaled with the breath.     The more red blood cells die the more CO is exhaled. That's why we can calculate the lifespan     of the red blood cells when we measure the amount of CO in breath at the same time as the red     blood cell count in the blood.      Aim of the study:      We aim to learn about the influence of inflammation of on red blood cell survival in dialysis     patients. To look for factors with effect on inflammation or red blood cell survival, for     example type of dialysis access, medication or kind of dialysis treatment.      Study procedures:      Over the course of the 18 month study, 6 observational assessments will take place. If the     patient experiences a situation with increased inflammation during the study period (for     example any kind of infection or intervention) up to two more study visits will take place.     Each study visit will include blood sampling, performed without the need for an extra needle     stick, and a breath sampling in order to calculate the red blood survival and to measure     markers for inflammation in the blood. The breath sample will be taken using the easy to use     GaSampler device developed by a company called Quintron especially for medical breath     sampling.      In order to get a sample of air at the patient's home for calculation of carbon monoxide     produced in the body we will ask the patients to take home an open empty plastic bottle     before each study visit. The bottle should be kept overnight on a table or sideboard in the     apartment. Before leaving home for hemodialysis or in clinic visit the patient will seal the     plastic bottle with the top, take it to the dialysis center and hand it to the research     staff.      Risks:      The amount of the additional blood drawn is 30 ml; this is the amount 2 tablespoons, at each     study visit. This does not harm the patient. The breath sampling does not imply any risk.   "
139247|NCT01462058|"     The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than     placebo in preventing depression symptoms among employees in health care   "
139248|NCT01462045|"     This study will explore the relationship between changes in plasma cortisol and symptom     reduction resulting from individuals with posttraumatic stress disorder (PTSD) participating     in an 8-week program of mindfulness-based stretching and breathing exercise. The     investigators hypothesize that at the completion of participation in the 8-week program,     exercise-induced symptom reduction will be associated with changes in cortisol levels.   "
139250|NCT01462019|"     Inadequate care during pregnancy and postpartum are predisposing factors for the emergence of     nipple fissures. The therapeutic approach of nipple trauma care guidelines aimed at the     breast and the appropriate techniques for breastfeeding. These measures, however, have a much     more preventive than curative, it is not, in most cases, sufficient to power the closing of     nipple trauma. The objective of this study was to evaluate the effectiveness of a     phototherapy device designed specifically for the treatment of nipple trauma.   "
139251|NCT01462006|"     Idiopathic pulmonary fibrosis (IPF) is an illness characterized by progressive decline in     lung function and premature death from respiratory failure. Fibrocytes are a novel population     of bone marrow-derived circulating progenitor cells that have been shown to traffic to the     lungs and contribute to fibrosis in animal models of pulmonary fibrosis, and whose numbers     correlate with the degree of fibrosis and with survival in human pulmonary fibrosis. The     investigators propose to test the hypothesis that therapy with the mTOR inhibitor, sirolimus,     reduces the number of circulating fibrocytes in patients with IPF. The investigators propose     to test this hypothesis in short-term pilot trial of sirolimus in patients with IPF to     determine its effect on the number and phenotype of circulating fibrocytes.   "
139252|NCT01461993|"     This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil     (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be     randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection     being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and     saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent     children between the ages of 11 and 17 years old.   "
139253|NCT01461980|"     This is a clinical study to assess the safety, tolerance and immunogenic response to     MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and     W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine.     Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized     into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to     all injections given throughout the study. An unblinded administrator will be responsible to     administer the vaccinations to all subjects and will be unblinded to the subject     randomization in order to determine which subjects were in randomized to group 3 so they may     receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be     conducted with all subjects 6-months post their last vaccination to obtain safety     information.   "
139254|NCT01461967|"     This randomized, double-blind, placebo-controlled, cross-over study will assess the safety,     pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects     will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part     2, subjects will receive a single dose of RO5508887 on two occasions, with or without food.     Anticipated time on study is up to 12 weeks.   "
139255|NCT01461954|"     This randomized, double masked, multi-center study is being conducted to support the safety     and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends to     show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution     of acute viral conjunctivitis.   "
139256|NCT01461941|"     The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment     in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after     topical application of E6005 is also assessed.   "
139257|NCT01461928|"     This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and     safety of subcutaneously administered rituximab in comparison with observation only as     maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's     lymphoma (NHL). All participants will receive induction therapy with rituximab (375     milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous     [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of     maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing     therapy and showing partial or complete response will be randomized to receive either     rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II     period and will be followed for at least 15 months. Anticipated time on study treatment is     until disease progression, unacceptable toxicity or end of study, whichever occurs first.   "
139258|NCT01461915|"     The purpose of the study is to determine whether ODSH (2-0,3-0 desulfated heparin), a low     anticoagulant heparin derivate with preserved anti-inflammatory and anti-neoplastic     characteristics is efficacious in patients with metastatic pancreatic cancer with gemcitabine     and nab-paclitaxel ( Abraxane) as first line therapy.   "
139259|NCT01461902|"     The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and     brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic     brain injury (TBI) patients who have experienced a mild to severe head injury.   "
139260|NCT01461889|"     Transfusion-related acute lung injury (TRALI) is the most common cause of transfusion-related     morbidity and mortality in the United States. It is very common and often unrecognized in the     critically ill with the greatest incidence occurring in bleeding patients with liver disease.     Plasma is the most blood component associated with this deadly complication and therefore     patients with liver disease who frequently receive transfused plasma are at increased risk.     The optimal plasma transfusion strategy for bleeding patients with liver disease is unknown     and the investigators will evaluate this clinical question in a small pilot randomized     controlled trial. The invstigators hypothesize that targetting a more restrictive INR Target     (2.5) vs. an INR Target (1.8) will result in less hypoxemia, a TRALI surrogate without     increasing bleeding complications.   "
139302|NCT01461343|"     The purpose of the study is to find out how the blood flow changes in the lungs of people     with pulmonary hypertension compared to healthy individuals without pulmonary hypertension.     We would like to find out if there are differences in how blood flows when subjects are given     a drug to dilate (widen) the arteries in their lungs and when they breathe extra oxygen. We     will compare the results to when subjects don't receive any drug or extra oxygen. We hope     that knowing about these differences will help us to better understand pulmonary hypertension     and how to diagnose it earlier.   "
147670|NCT01351350|"     This is a Phase I, Open Label, Dose Escalation Study of Oral Administration of MLN0128 in     Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid     Malignancies   "
139261|NCT01461876|"     This is a retrospective longitudinal study that evaluates the prevalence and incidence of     overweight/obesity within an HIV-infected population before and after 12 and 24 months of a     stable antiretroviral therapy (ART). The study group will be compared to the weight of a     healthy, matched population that is not infected with HIV. The primary hypothesis states that     the proportion of HIV-infected persons newly classified as overweight/obese will increase by     ≥20% after 12 months of initial ART, and this incidence will be greater than that of a     matched HIV-uninfected control population. The effect of immune function variables, such as     CD4, HIV viral load, and ART regimen on weight will be analyzed. In addition, the study will     analyze the effect of weight and immune function markers on the inflammatory markers, high     sensitivity C-reactive protein (hsCRP) and D-dimer. An HIV samples repository will be used     for specimens to be assayed for hsCRP and D-dimer.   "
139262|NCT01461863|"     This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie     supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health     outcomes for HIV-infected pregnant women and their infants.   "
139263|NCT01461850|"     Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will     be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs.     neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point     is the evaluation and comparison of the surgical complications of primary surgery and IDS and     the evaluation of the progression free survival (PFS)   "
139264|NCT01461837|"     This study is being done to determine the safety and outcome (long-term control) of a     high-dose chemotherapy regimen followed by an infusion of CD34 selected (immune cells) stem     cells from a partially matched adult family member donor, called haploidentical stem cell     transplantation, in high-risk sickle cell disease patients.      Funding Source - FDA OOPD   "
139265|NCT01461824|"     The investigators are doing this study to look at how different doses of the Depot     medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens.     The investigators hope that what the investigators learn from this study will be used to     develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.   "
139266|NCT01461811|"     The purpose of this study was to demonstrate substantial equivalence of an investigational     toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens     when worn in a daily wear, daily disposable mode for three months.   "
139267|NCT01461798|"     Introduction:      Cardiovascular diseases have become the leading cause of death from chronic diseases in the     world. One of the major risk factors for this disease is hypercholesterolemia, caused in most     cases by a rich-fat diet, so came to our country Benecol ® yogurt, whose active ingredient is     plant stanol ester that competes with total cholesterol and low density lipoprotein or LDL     cholesterol by preventing them to be absorbed by the body and reducing blood levels.      Objective: To evaluate the efficacy of plant stanol ester in Benecol ® yogurt lowering blood     lipids in moderately hypercholesterolemic patients treated at the CES Clinic during 2011.      Methods: A randomized crossover clinical trial, double-blind, placebo-controlled study in     patients between 20 and 50 years with moderate hypercholesterolemia and are cared for CES     control clinic in Medellin.      Expected results: Test the effectiveness of plant stanol esters in reducing total cholesterol     and LDL cholesterol in patients with moderate hypercholesterolemia.   "
139268|NCT01461785|"     In this prospective, randomized clinical trial, lipofilling of the midface with Platelet Rich     Plasma (PRP) is compared with lipofilling of the midface without PRP. The main objective of     this study is to investigate the effect of the addition of PRP to the autologous fat transfer     on local skin quality improvement, graft survival, and recovery after the procedure.   "
139279|NCT01461642|"     The purpose of the study is to establish and clinically evaluate a new approach to treating     asthma by using information and communication technologies (ICT). A mobile environment, and     organizational interventions to improve the process of an integrated treatment of people with     asthma will be identified, developed, introduced and clinically evaluated.   "
139269|NCT01461772|"     Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for     patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal     toxicity and not convenient regimen. Recently, carboplatin has proved to be a good     radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for     both patients and physicians. Weekly carboplatin may have similar efficacy with weekly     cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to     evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in     patients with locally advanced cervical cancer.   "
139270|NCT01461759|"     The purpose of this study is to treat advanced or recurrent endometrial cancer,     paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by     most physicians. Docetaxel may have similar efficacy and more favorable treatment related     toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators     aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with     advanced or recurrent endometrial cancer.   "
139271|NCT01461746|"     Previous some studies suggested the addition of chemotherapy to radiation therapy after     surgery may have survival benefit in patients with high risk endometrial cancer. In addition,     docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin     which is currently used in most cases. However, docetaxel plus cisplatin may cause less     toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to     analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after     surgery in patients with high risk endometrial cancer.   "
139303|NCT01461330|"     Data obtained in hypertensive patients without diabetes suggest that increased association of     non-pharmacological treatment in patients with diabetes and hypertension may be associated     with an improvement in blood pressure control. Despite the beneficial results found, is not     yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical     activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of     an additional non-pharmacological intervention to drug therapy may have an even greater     impact in patients with treatment-resistant hypertension The aim of this study is to evaluate     the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and     hypertension resistant to treatment.   "
139272|NCT01461733|"     Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are     admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence     that resolves as the patient recovers from their underlying condition. However, patients who     develop AF can present with a very rapid heart rate that in some cases can put stress on the     heart which can lead to life threatening heart attacks, low blood pressure or breathing     problems. Not all patients with AF will have unstable heart function but those who have rapid     heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no     unstable heart function are two fold. Patients can be treated by controlling the heart rate     and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be     controlled by medication and the AF can be converted by either electrical cardioversion (an     electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal     of treatment should be to simply control the heart rate and wait for the patient to     spontaneously convert to a normal heart rhythm or convert the AF with medication for patients     who only have the rapid heart rate.      The objective of this project is to conduct a pilot study to determine if it would be     feasible to conduct a larger definitive trial that would answer the following question:     Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart     rhythm in patients with AF who have a rapid heart rate without unstable heart function.   "
139273|NCT01461720|"     This study aims to determine the efficacy of intravenous transplantation of autologous bone     marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.   "
139274|NCT01461707|"     Obesity among women of childbearing age and excessive weight gain during pregnancy are     prevalent and steadily increasing health care issues. Regular physical activity is     recommended to maintain healthy weight gain for pregnant women, however, a majority of     pregnant women are sedentary. The investigators propose to conduct a pilot study to estimate     the potential efficacy of a mobile phone based physical activity intervention in 30     physically inactive pregnant women.   "
139275|NCT01461694|"     The purpose of this study is to compare the efficacy of the IPL system 650advance handpiece     with the alexandrite laser for the purposes of female facial hair reduction   "
139276|NCT01461681|"     Heart failure (HF) affects more than 5 million Americans and is a major source of morbidity     and mortality. Despite optimal management, over half of patients with HF suffer from pain,     dyspnea, fatigue, and depression that diminish quality of life (QoL). HF care also exacts a     huge financial toll with yearly costs of $35 billion. Although consensus guidelines call for     providing palliative care (PC) to patients with HF to relieve suffering and improve QoL, few     receive it. The overall aim of this project is to conduct a randomized controlled trial (RCT)     to determine if an interdisciplinary PC intervention (Symptom Management Service-HF [SMS-HF])     provided concurrently with standard cardiology care improves symptoms, QoL and satisfaction,     and reduces resource utilization in outpatients with Class II-IV HF compared to standard     cardiology care alone. Subjects assigned to the SMS-HF group will receive a 6-month     interdisciplinary PC intervention based on the investigators successful SMS model of     outpatient PC for oncology patients and focused on assessment and management of physical,     emotional, social, and spiritual distress and discussion of treatment preferences.     Innovations of this study are that it will rigorously assess the impact of the SMS-HF on     patient outcomes and on resource utilization, a key component to ensuring program     sustainability. The investigators research team of PC and HF experts is recognized for its PC     research and has a proven record of collaborating, conducting RCTs of PC interventions, and     studying outpatients with HF. The environment at UCSF is highly supportive of innovative     research and of sustaining programs with demonstrated improvements in patient outcomes and     operational effectiveness. The overall goal is to use the results from this study to support     an application to the NIH for a multi-center RCT of the SMS-HF and to study similar models of     concurrent PC for patients with other serious illnesses.   "
139277|NCT01461668|"     The investigators will conduct a randomized placebo-controlled double-blinded study of nasal     decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among     adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC >256)     strains.      Objectives:        1. To determine the percent of intervention vs. control patients with successful MRSA nasal          decolonization as determined by bilateral nares swabs following a 5-day twice-a-day          regimen of retapamulin.        2. To determine the time to decolonization based upon interim and final bilateral nares          swabs.        3. To determine the acceptability of retapamulin by surveying participants about their          experience and adverse events experienced during this study.      The duration of participant follow-up is expected to last up to 7 weeks.      This study will evaluate the safety and effectiveness of Altabax (retapmulin) during     decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and     high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is     no approved substitute topical agent for decolonization of the MRSA nasal reservoir.   "
139278|NCT01461655|"     The aim of this proof of principle study is to evaluate efficacy and safety of the sequential     application of two marketed products for the treatment of acne vulgaris, using the Split-Face     model   "
139280|NCT01461629|"     The purpose of this study is to assess the relationship between cognitive impairment, patient     self-management, health, and health service use in adults with heart failure (NYHA Class 2     and 3). The research questions are:        1. How is cognitive impairment (memory, attention, global and executive function) related          to various aspects of impaired self-management (knowledge of adherence, adherence to          sodium restriction and medications, symptom monitoring of weight changes, and decision          and action to seek care)?        2. How are these relationships altered when adjusting for medical, demographic, and          psychosocial factors?        3. What are the relationships among degree of cognitive impairment, quality          self-management, health status, and health service use?   "
139281|NCT01461616|"     The objective is to describe the interaction of equal doses of NPH insulin (Neutral Protamine     Hagedorn), insulin Detemir and insulin glargine on IGFBP-1 (Insulin-like Growth Factor     Binding Protein-1) production as well as immunoreactive and bioactive IGF-I (Insulin-like     Growth Factor-I) after once-daily injection on three separate visits in type 1 diabetic     subjects.   "
139304|NCT01461317|"     This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of     etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled     in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in     the OLE study.   "
139305|NCT01461304|"     This is a compassionate use study to allow patients already taking triheptanoin (C7) through     previous studies to continue to receive the supplement. It will also allow triheptanoin     supplementation in patients with qualifying disorders if they are failing conventional     therapy.   "
139282|NCT01461603|"     Introduction: Protein loss during critical illness is an important problem and is shown to     predict overall survival. In animal studies, infusion of leucine is shown to increase the     synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.      Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral     artery will promote protein synthesis and inhibit breakdown assessed with local a/v     phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include     distinct alterations in muscle signal events, in particular mTOR.      Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv.     femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and     a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of     arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain     continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution     FFa-3OHB.      Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on     muscle protein metabolism in humans and contribute to further development of nutritional     therapy in human catabolic states.   "
139283|NCT01461590|"     Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations,     given to children with severe anaemia will be beneficial in haematological correction and can     be given safely since respiratory distress and haemodynamic changes result from acidosis and     compensation in these children rather than from biventricular failure.   "
139284|NCT01461577|"     Primary Objective:        -  To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from          baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.      Secondary Objective:        -  To determine the change in glycemic control, safety, and treatment satisfaction in          insulin glargine use in patients following GLP-1 failure.   "
139285|NCT01461564|"     Colonoscopy is currently most effective procedure used for detecting colon cancer especially     in the early stages. Screening colonoscopies are performed in the symptom-free patients at     risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel     may be retained after the procedure causing pain and discomfort to the patients. One of the     methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of     air during colonoscopy.      Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.   "
139286|NCT01461551|"     Most researches revealed that volatile anesthetic sevoflurane has a more marked     cardioprotective effect against ischemia compared with intravenous agent propofol.However,     propofol has been suggested to be more benefit for attenuation of surgery-induced     immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB     surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol     and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating     lymphocytes.   "
139287|NCT01461538|"     This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity     of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous     malignancies.   "
139288|NCT01461525|"     Sphincter preservation surgery in low rectal cancer has been increased due to better     understanding of tumor biology and advances in surgical technology. Furthermore, a majority     of patients prefer sphincter preservation rather than living with permanent colostomy. But it     is not clear whether sphincter preservation is directly related with better quality of life.     There have been many studies comparing sphincter preservation surgery and abdominoperineal     resection in many aspects including oncologic and functional outcomes, and the quality of     life. However, the conclusion remains controversial because of the different results between     studies.   "
139289|NCT01461512|"     Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed     protective effects during prolonged ischemia in animal studies. Functional blood oxygen level     dependent (BOLD) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1     induction during short-time ischemia in skeletal muscle of healthy subjects.   "
139290|NCT01461499|"     The purpose of this study is to compare the effects of a direct renin inhibitor (DRI),     aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes     under strict blood pressure control with angiotensin receptor blocker (ARB).   "
139299|NCT01461382|"     Is a one-year intervention with Treadmill Desks associated with increased employee daily     physical activity and decreased sedentariness.      36 employees with sedentary jobs (87 + 27 kg, BMI 29 + 7 kg/m2) used a Treadmill Desk for one     year. Daily Physical Activity, work performance, body composition, and blood variables were     measured at Baseline and 6 and 12 months after the Treadmill Desk intervention.   "
139300|NCT01461369|"     The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and     effective for the treatment of osteoarthritis pain of the hip or knee.   "
139301|NCT01461356|"     The hypothesis of the proposed study is that performing total knee arthroplasty through a     mini subvastus approach results in statistically significant differences in one or more of     the above functional outcome measures, when compared in a blinded, prospective, controlled,     randomized manner to mini-medial arthrotomy approach.        1. Analyses of lower extremity functional activities (gait and stairs)        2. Strength of thigh musculature        3. Self-assessment of the functional outcomes        4. Return to the activities of daily living and sports activities   "
139306|NCT01461291|"     Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400     using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery     only, in subjects with mild to moderate primary open-angle glaucoma.   "
139307|NCT01461278|"     Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction     with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate     primary open-angle glaucoma.   "
139308|NCT01461265|"     This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain     associated with metastatic bone tumors.   "
139309|NCT01461252|"     This study will evaluate the safety and efficacy of cryoablation therapy combined with     radiation therapy for the relief of pain associated with metastatic bone tumors.   "
140801|NCT01441531|"     The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po)     before surgery will help prevent the development of tourniquet pain and hypertension while     the tourniquet is inflated during orif of tibia fracture.   "
139291|NCT01461486|"     Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway     pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study     is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness,     cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic     cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea     -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body     mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must     have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three     groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline     evaluation, six months, one year and three years, all subjects will be submitted to sleep     questionnaires, physical examination, ear-nose and throat evaluation, baseline     polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness     Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale,     Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of     Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality     of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory,     metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood     pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three     groups. Analysis mean and standard deviation will be used for descriptive statistical and a     general linear model will be applied for analysis within groups on different time.   "
139292|NCT01461473|"     STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure     that prospectively enabled access to and the sharing of clinical and research data.      STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway     pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in     cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data     collected during the STAGE II study was incorporated in Part 3 of the STAGE I study.      STAGE III of the COMET study was completion of data analysis and preparation of the     electronic network informatics infrastructure for use beyond the four Clinical Centers to     interested CTSA institutions. We also explored expanding ontologies, and the use of federated     database methodology.   "
139293|NCT01461460|"     The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus     placebo on QTcF.   "
139294|NCT01461447|"     The purpose of the study is to determine the safety and immunogenecity of a third MVA in the     HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA     vaccines.      The investigators postulate that the Immune responses that were observed in the HIVIS 03     trial are likely to wane over time. To date it is unknown how these responses should best be     maintained. In this study the investigators seek to boost immune responses, especially the     antibody responses induced by the second MVA boost.      Since the HIV specific antibodies were induced only after the second MVA injection, it is     hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.   "
139295|NCT01461434|"     Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with     increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient     characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF     has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in     patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease).     However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving     patients at risk.      Aim of the prospective randomized study is to compare two management strategies for patients     at increased risk for AF but without a known history of AF. Patients are seen regularly     (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of     patients additionally receives a subcutaneous implantation of a loop recorder for continuous     rhythm monitoring, while the control group remains on standard follow-up. Observation period     is one year (optional extension for 3 years). The time to first diagnosis of AF is compared     between groups, blood samples are analyzed for potential biomarkers of AF.   "
139296|NCT01461421|"     The proposed project is testing two behavioral interventions designed to improve long-term     weight loss among participants who struggle with eating in response to stress or emotional     experiences. Group treatment lasts for 1 year, with assessments lasting 2 years. Participants     must live in the greater Providence, Rhode Island area in order to be eligible.   "
139297|NCT01461408|"     The investigators propose a non-randomized pilot study to assess the feasibility and     effectiveness of using urban beauty salons as settings for culturally-competent health     education about HPV vaccination. The educational messages will engage individual women, their     peer group, their family members and community influencers in a way that is authentic and     share-able. Involving women in give-and-take discussions with people they trust and     respect—their hairdressers—will be essential to increasing the number of them who consider     the HPV vaccine for themselves and for those they care about. The investigators believe that     it is only after women who are opinion leaders among their peers begin positively supporting     HPV prevention that it will gain wider acceptance.      The investigators plan to recruit eight (8) predominantly African American beauty salons in     Philadelphia and train multiple stylists in each salon to act as in-salon educators and     facilitators for client recruitment to sexual health education sessions. These education     sessions will be run by trained health educators (also African American females) and take     place during down times in each of the salons, on a rotating basis.        -  The investigators hypothesize the ability to successfully recruit eight (8) beauty          salons for participation        -  The investigators hypothesize the ability to successfully train multiple stylists per          site to talk to their clients about HPV and its impact on women of color        -  The investigators hypothesize that knowledge and awareness of HPV, as well as intentions          to vaccinate will significantly improve among women who attend a salon-based health          education session   "
139298|NCT01461395|"     The purpose of this study is to find a non-invasive way to discover DNA (deoxyribonucleic     acid, which is the genetic material inside your cells) alterations in the sperm's head, in     the near future leading us to choose the good sperm in a simplified manner. This could then     increase chances of a successful in-vitro fertilization (IVF) treatment when there are sperm     abnormalities.   "
139310|NCT01461239|"     There are few randomized controlled trials comparing intraradicular posts used to restore     endodontically treated teeth, especially considering cast posts and glass fiber posts. The     investigators study will evaluate the clinical success rates of endodontically treated teeth     restored with glass fiber posts or cast posts and metal ceramic crown. Individuals included     in this study should present any tooth with endodontic treatment and need of intraradicular     retention (post) on maxilla or mandible according to inclusion and exclusion criteria.     Individuals will be randomly allocated into two groups: (1) endodontically treated teeth     restored with fiber post and composite resin core and metal ceramic crown or (2)     endodontically treated teeth restored with cast post and core and metal ceramic crown. A     sample size calculation will be performed to establish the number of posts needed for     comparison. All crowns and posts will be cemented with self-adhesive cement. Individuals will     be examined by calibrated examiners, in years 1 to 3. The reason of failure will be     categorized as root fracture, fracture of the post, post debonding, clinical and/or     radiographical evidence of a gap between restoration and tooth or endodontic failure, tooth     extraction, secondary caries, or marginal defects. The confidence level will be set in 95%.   "
139311|NCT01461226|"     The purpose of this study is to objectify the effect of diet and exercise on early markers of     atherosclerosis in obese children.   "
139312|NCT01461213|"     - Primary objective: To assess the safety and tolerability of the AAV.REP1 vector,     administered at two different doses to the retina in 12 patients with a diagnosis of     choroideremia.      - Secondary Objective: To identify any therapeutic benefit as evidenced by a slowing down of     the retinal degeneration assessed by functional and anatomical methods in the treated eye     compared to the control eye 24 months after gene delivery.   "
139313|NCT01461200|"     The purpose of this study is to find out if the bacteria present in the nose or sinuses of     people with seasonal allergies changes during their allergy season. Another purpose of this     study is to see if the bacteria present in the nose and sinuses of non-allergic people are     the same as allergic people before the allergy season and if it changes during the season.     Many bacteria are difficult to grow in the laboratory so the investigators are using analysis     of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them.     The investigators will be testing DNA of the bacteria only and not of the human subjects     taking part in this study. This research is being done to help us understand how allergy     affects bacteria in the nose and sinuses.   "
139314|NCT01461187|"     Abstract:      Objectives:[The goal is] to confirm if physical activity of medium intensity performed during     gestation can influence the way of delivery, and observe the adherence to exercise among     pregnant women with different education levels. Methods: Held at the Center for Breastfeeding     Incentive in the city of São Sebastião, State of São Paulo (Brazil), between April 7, 2008     and April 14, 2009, the prospective study involved 66 primigravid women, who were divided     into two groups: the exercise group (GE) that exercised regularly during pregnancy, and the     other control group (GC) that did not exercise regularly during same period. The significance     level adopted in this study was five per cent (p = 0.05).   "
139315|NCT01461174|"     The aim of this study is to assess the utility of sleep deprivation as a potential model for     prediction of clinical efficacy using a combination of cognitive physiological endpoints.   "
139316|NCT01461161|"     This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl     administered to normal healthy adult subjects.   "
139360|NCT01460563|"     The investigators hypothesized that valproic acid will increase rocuronium requirement and     MgSO4 infusion would reduce requirement of muscle relaxant in craniotomy patients preloaded     with sodium valproate.   "
139317|NCT01461148|"     Patients with advanced microsatellite unstable (MSI-H) colorectal cancer will be vaccinated     with three so called frame shift peptides (FSPs), AIM2(-1), HT001(-1) and TAF1B(-1) combined     with Montanide® ISA-51 VG. By this, an immune response directed against MSI-induced FSPs that     are shared by the majority of MSI-H colorectal cancers can be induced. The aim is to show     that vaccination against MSI-induced FSPs is safe and can induce or enhance immune responses     against MSI-H colorectal cancer-associated antigens.   "
139318|NCT01461109|"     The underlying goal of this study is to assess [18F] CFPyPB PET imaging as a tool to evaluate     the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer     Disease (AD) research participants.   "
139319|NCT01461096|"     Men who have sex with men (MSM) have an increased risk of developing anal human     papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected     women are also at risk of anal cancer. This study will evaluate the effectiveness of the Food     and Drug Administration (FDA)-approved quadrivalent HPV vaccine, Gardasil, at preventing anal     HPV infection in HIV-infected MSM and HIV-infected women.   "
139320|NCT01461083|"     The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate     the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research     participants.   "
139321|NCT01461070|"     Background:      - Some bacteria found in the large and small intestines help keep people healthy and aid     digestion. They may also affect a person s risk of developing cancer. Researchers want to     study the relationship between intestinal bacteria and breast cancer risk factors. They can     do this by looking at stool and urine samples from postmenopausal women.      Objectives:      - To study intestinal bacteria and its relationship to urine-based markers of breast cancer     risk in women.      Eligibility:      - Women between 55 and 69 years of age with a recent mammogram that showed no signs of     cancer.      Design:        -  Participants will be screened with a medical history and basic health questionnaire.        -  At home, participants will complete questionnaires about cancer risk factors and food          consumption.        -  Participants will also collect urine and stool samples. They will send the samples to          the designated labs for study.        -  No treatment will be provided as part of this protocol.   "
139338|NCT01460849|"     Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from     first year of TIS eligibility, estimate the increased risk of death attributable to each year     of delayed TIS initiation, and investigate TIS effects across study centers.   "
139339|NCT01460836|"     Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine     (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data     from published literature.   "
139322|NCT01461057|"     This randomized, multicenter, open-label study will evaluate two different doses of     pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line     treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or     gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment     arms. Participants in Arm A will receive a pertuzumab loading dose of 840 mg for Cycle 1 and     a dose of 420 mg for Cycles 2-6, and participants in Arm B will receive pertuzumab 840 mg for     all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and     capecitabine.   "
139323|NCT01461044|"     This observational study will evaluate the safety and efficacy of triple negative or HR+     patients with HER2-metastatic or locally advanced breast cancer treated with Avastin     (bevacizumab) as first line therapy for at least 12 months and without disease progression     for at least 12 months. Data will be collected retrospectively (from the diagnosis to the     inclusion in the study) and for 18 months from study start.   "
139324|NCT01461031|"     The aim of this study is to determine the analgesic effect of perioperative nefopam on acute     pain in patient undergoing orthognathic surgery.   "
139325|NCT01461018|"     The purpose of this study is to assess the long-term efficacy, tolerability, and safety of     IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding     follow-up study ZLB07_001CR (NCT01458171).   "
139326|NCT01461005|"     The purpose of the Post-Market Surveillance study is to evaluate safety.   "
139327|NCT01460992|"     This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS     pacemaker system when used under specific MRI conditions.   "
139328|NCT01460979|"     The purpose of this study is to determine the activity, tolerability and safety of     Temsirolimus in women with ovarian cancer who progressed during the previous platinum     chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial     carcinoma.   "
139329|NCT01460966|"     Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for     distal embolism in Acute coronary syndrome(ACS). The purpose of this study is to assess the     effect of thrombus aspiration catheter and distal protection device (filter wire; Filtrap™)     in the aforementioned subgroup of patients at high risk for distal embolism.   "
139330|NCT01460953|"     1. Briefly describe the purpose of this protocol: This study is designed to evaluate the          effectiveness of an educational training video on the topic of health literacy for          medical students.        2. Briefly summarize how participants are recruited: OHSU medical students attending          mandatory trainings on the topic of health literacy during the 1st and 2nd years of          medical school will be invited to participate in the study.        3. Briefly describe the procedures subjects will undergo: Completion of a short          self-administered anonymous survey before and after viewing a 23-minute video about          health literacy.        4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test          questionnaire and 13-item post-test questionnaire designed to assess individuals'          knowledge about health literacy, and intended clinical practices with respect to health          literacy.        5. If this is a clinical trial using an experimental drug and/or device, or an approved          drug and/or device used for an unapproved purpose, briefly describe the drug and/or          device: n/a        6. Briefly describe how the data will be analyzed to address the purpose of the protocol:          Demographics and responses to individual items will be reported as frequencies and          percentages within the sample. The investigators will use a chi-square analysis to          stratify responses by demographic groups and t-tests to measure possible changes over          time.   "
139331|NCT01460940|"     This phase II trial studies how well giving panobinostat together with lenalidomide works in     treating patients with relapsed or refractory Hodgkin lymphoma. Panobinostat may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop     cancer cells from growing. Giving panobinostat together with lenalidomide may be an effective     treatment for Hodgkin lymphoma   "
139332|NCT01460927|"     The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source,     the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple     treatments. The primary endpoint is observation of changes to the surface by visual and     photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort     of the treatment and the measurement of adverse events.   "
139333|NCT01460914|"     Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which     the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV     light. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also     effective for graft-versus-host disease (GVHD). The investigators would like to study the     outcomes (response rates) of patients receiving ECP treatment and other factors relating to     their disease and treatment, as well as procedural events, such as complications.   "
139334|NCT01460901|"     This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic     transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory     neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated.     The study will focus on the safety and efficacy of allogeneic, donor derived viral specific     cytotoxic T-lymphocytes, retrovirally transduced to express a chimeric antigen receptor     specific for disialoganglioside, GD2, expressed on neuroblastoma.   "
139335|NCT01460888|"     The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of olaparib in     combination with radical radiotherapy in patients with oesophageal cancer who are unsuitable     for platinum containing chemotherapy.   "
139336|NCT01460875|"     This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with     melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and     slow the growth of melanoma   "
139337|NCT01460862|"     A retrospective database analysis to evaluate the impact of omalizumab on the use of     corticosteroid, emergency-department visits and hospitalizations among patients with     uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating     omalizumab.   "
139414|NCT01459848|"     The investigators will do an experiment where 9-12 month old infants are randomized to 30     minutes of block play or 30 minutes of watching a baby DVD.   "
139340|NCT01460823|"     The investigators are studying a new way of doing cochlear implant surgery called     Percutaneous Cochlear Implantation. In this surgery, instead of doing a mastoidectomy where     about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS     systems used to guide automobile travel) to drill directly from the surface of the skull to     the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor     screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT     scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill     guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the     guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The     implant electrode will be threaded through this path. All of these procedures take place     under general anesthesia.   "
139342|NCT01460797|"     The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research     on Glycemic Index (GI) diets has been largely developed, however the combination with     metformin in humans was not investigated yet. We hypothesized that the low-GI diet in     combination with metformin would elicit greater improvements on glucose metabolism, lipid     profile and body composition on overweight or obese type 1 subjects. This study aims to     evaluate the metabolic effects of the adoption of dietary advice to follow caloric     restriction high/low GI diets, and low-GI diet associated with metformin on glucose     metabolism, lipid profile and body composition on overweight or obese type 1 subjects.   "
139343|NCT01460784|"     The investigators propose to conduct a cross-sectional study of 60 participants who are 18-30     years of age to undergo research PET/CT. The purpose of this study is to investigate the     relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and     components of the metabolic syndrome in young adults.   "
139344|NCT01460771|"     The investigators hypothesize that transcranial direct current stimulation over the motor     cortex will reduce muscle overflow and improve hand function in children with primary or     secondary dystonia.   "
139345|NCT01460758|"     Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal     excitability in patients with depression. In the present study the investigators will examine     whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional     high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.   "
139346|NCT01460745|"     This study is a multi-centre retrospective observational research study which will be     conducted in UK centres with specialised liver surgical services.      The study will involve retrospective review of medical records of patients with metastatic     colorectal cancer (mCRC) with metastases confined to the liver, defined locally as     unresectable without downsizing therapy at first review by a Hepatobiliary Multi Disciplinary     Team (HPB MDT). Erbitux is available for use in combination with chemotherapy as a downsizing     treatment for patients with previously unresectable metastases.      The study aims to examine liver resection rates achieved in normal clinical practice in order     to inform National Health Service (NHS) clinical and policy decision making and to further     understanding of how cetuximab is used in a standard clinical setting. This study intends to     estimate the proportion of patients with unresectable liver metastases who undergo liver     resection following downsizing treatment with chemotherapy plus cetuximab.   "
139347|NCT01460732|"     This is a cross-sectional study, including adults, either untreated for hypertension, or     under stable treatment for more than four weeks. Assessment will include:      Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory     blood pressure monitoring Home blood pressure monitoring during morning, evening and     nocturnal measurements with the same device.   "
139348|NCT01460719|"     An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated     Varicella-Zoster Virus (V212) vaccine in participants with hematologic malignancies (HM) who     are currently receiving anti-CD20 monoclonal antibodies.   "
139349|NCT01460706|"     The purpose of this study is to characterize tumour uptake of somatostatin analog     68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators     hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor     which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor     uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status     of the tumor specimen.   "
139350|NCT01460693|"     Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed     Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates     an 89% probability of progression-free survival. Imatinib is not tolerated or effective in     some patients however, and a proportion of patients become resistant to the drug. SPIRIT 2     study aims to establish whether a new drug, dasatinib, is superior to imatinib in terms of     event free survival and therefore will be an effective first-line therapy for newly-diagnosed     CML patients. This study will also provide crucial long-term survival, quality of life and     health economic data to assist health care providers and managers to determine the most     cost-effective drug therapy for CML.   "
139351|NCT01460680|"     Polyunsaturated omega-3 fatty acids (ω3 PUFAs) are essential nutrients. Studies indicate that     the incidence of Major Depression (MD) is inversely related to the consumption of fish (which     are rich in ω3-PUFAs) and to the concentration of ω3 PUFAs in the plasma or Red Blood Cell     (RBC) membranes. In several studies, the ω6 to ω3 ratio was elevated (ω6 PUFAs are     pro-inflammatory, compared to ω3). ω3 PUFAs are also inversely associated with anxiety and     neuroticism but apparently not with somatization.      Supplementation of fish oil alleviates joint pain in patients with auto-immune disease.     Inhibition of pro-inflammatory cytokines (which induce both pain and depression-like     symptoms) by ω3 PUFAs may underlie the benefit conferred by fish oil consumption . RBC ω3     PUFA content is lower in patients with Systemic Lupus Erythematosus and chronic fatigue     syndrome, compared to healthy controls. The ω3 PUFA status of fibromyalgia patients has not     been assessed.      Magnesium is an essential nutrient and plays a regulatory role in neural transmission. It is     not known whether magnesium concentration is associated with pain in humans.      The objectives of the current study are to 1) compare the mean RBC omega-3 content in female     fibromyalgia patients compared to that of healthy controls and female SLE patients, and to 2)     assess the correlation between RBC omega-3 content and between the severity of physical (e.g.     pain) and mental (e.g. depression) in fibromyalgia and Systemic Lupus Erythematosus (SLE).   "
139352|NCT01460667|"     Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of     stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV)     and recovery of bowel function. Medications most commonly used to control for post-operative     pain are opioid medications, whose well known adverse effects include PONV. Currently, no     studied adequate alternative to opiates exists for mild-moderate pain relief without the     aforementioned risks.      The primary goal for this study is to evaluate the the administration of pre- and     post-operative IV acetaminophen to determine if there is in an overall decrease in the use of     opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective     PONV leading to sooner return of bowel function, enabling progression to oral intake and     decrease in post-operative length of stay.   "
139353|NCT01460654|"     This study will investigate the hypothesis that the combination of testosterone replacement     and alendronate will improve bone density and parameters of bone quality more than either     medication alone in older men with low testosterone levels and low bone density.   "
139354|NCT01460641|"     A research study of rectal cancer perfusion (how blood flows to the rectum over time). We     hope to learn whether perfusion characteristics of rectal masses may be predictive of     response to treatment and whether rectal perfusion characteristics can be used to follow     response to treatment.   "
139355|NCT01460628|"     The purpose of this study is to determine if armodafinil improves quality of life and is an     effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.   "
139356|NCT01460615|"     The purpose of this randomized, placebo-controlled trial is to investigate whether     postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy     (Whipple) operation may be reduced with cortisone treatment. Treatment is administered to     high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).   "
139357|NCT01460602|"     This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan     (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell     Lymphoma.   "
139358|NCT01460589|"     This study sets up the final study end point and three detailed goals as the following.      The main objective of study: This trial is done to assess the safety and benefit of early     adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional     commencement after 2weeks for treatment of patients with colon cancer.      Detailed goal of study:      The primary endpoint: This study is designed to assess whether early commencement of adjuvant     chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate.      The secondary endpoint: This study aims to compare short-term cumulative complications     between early and conventional commencement of adjuvant chemotherapy after laparoscopic     resection of colon cancer. This study will also assess the quality of life and side effects     of chemotherapy.   "
139359|NCT01460576|"     The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and     long-term breathing problems in preterm infants by investigating two interrelated biochemical     pathways: the urea cycle-nitric oxide pathway and the glutathione pathway. The investigators     hypothesize that prematurity-related limitations in the function of these important     biochemical pathways contribute to respiratory disease risk over the first year of life.   "
139362|NCT01460537|"     This open label Phase I study involves treating subjects with advanced cancer with Copanlisib     in combination with either gemcitabine or cisplatin plus gemcitabine. It will determine the     maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Copanlisib in combination     with gemcitabine and Copanlisib in combination with cisplatin and gemcitabine. The trial will     involve multiple participating sites from the US. Up to a maximum of 70 subjects will be     enrolled in the study.   "
139363|NCT01460524|"     In randomized controlled trials, the use of nebulized hypertonic saline in acute     bronchiolitis has been reported to improve respiratory distress scores, to reduce length of     hospital stay and to show a trend towards lower hospitalization rates.      The investigators aim to verify by an observational study if the rate of hospital admission     and the length of hospital stay of infants presenting to the emergency department (ED) with     bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the     treatment strategy of the ED and hospitalization wards.      The investigators will assess the evolution of hospital admission rates and the length of     hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment     of bronchiolitis and in two hospital that do not use these nebulizations. If nebulized     hypertonic saline is effective in this setting, then the hospitalization rates and length of     stay should be lower during the year of hypertonic saline use compared to two previous years     when this therapy was not used. These parameters would not be modified in centers that do not     use hypertonic saline.   "
139364|NCT01460511|"     This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week     study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo     HFA-MDI in pediatric patients who are 4-11 years of age with asthma.   "
139365|NCT01460498|"     This is a 2 part study. The goal of the first part of this clinical research study is to find     the highest tolerable dose of azacitidine that can be given with a TKI that you are already     taking (such as Gleevec, Sprycel, or Tasigna). The safety of this drug will also be studied.     The goal of the second part is to see if this combination may improve your response to the     TKI you are already taking.      Azacitidine is designed to change genes that are thought to cause leukemia. By changing these     genes, the drug may help to stop them from causing the disease to grow.   "
139366|NCT01460472|"     This is a prospective, randomized, open label, parallel-group, multicenter phase III study to     evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best     supportive care versus best supportive care in patients with advanced NSCLC who have achieved     an Objective Response (Partial or Complete Response) or Stable Disease with standard     first-line treatment. Also immunological parameters will be evaluated. Best supportive     therapy will be administered to all patients in the study according to institutional     standards and includes any subsequent onco-specific therapies. 1082 patients will be included     in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.   "
139415|NCT01459835|"     This study tests the hypothesis that modifying the media diet of preschool children so that     they watch more prosocial programming and less violent programming will result in decreased     aggression and increased prosocial behavior.   "
139367|NCT01460459|"     Primary Objective:      The objective of the study is to investigate the effect of a specific frequency of     Self-monitoring of blood glucose (SMBG) on glycemic control and quality of life in patients     with type 2 diabetes and who are in stable good glycemic control and using 1 insulin     injection daily.      The research question is:      Does a less intensive frequency of SMBG in insulin-treated patients with type 2 diabetes, who     are in stable good glycemic control, using 1 insulin injection daily, lead to a clinically     relevant increase of HbA1c (an increase of 0.5%) and what is the effect on quality of life?      Secondary objectives:      The secondary objectives is to investigate the effect of a specific frequency of SMBG on the     number of hypo and hyper glycaemia, number of extra diabetes-related contacts with the health     care provider, and the diabetes medication.   "
139368|NCT01460446|"     This clinical, prospective, randomized, multi-center study determined if the use of an     insulin bolus advisor improves glycemic control as measured by a change in HbA1c in patients     failing multiple daily injection/intensified conventional therapy (MDI/ICT).   "
139369|NCT01460433|"     The aim of this study is to find out if the process of HIV replication in the lymph tissue     and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut     to protect you from other infections and health problems.   "
139370|NCT01460420|"     The aim of the current study is to improve the outcome of patients with hematologic     malignancies (in a phase I trial) and more specifically multiple myeloma (in a phase II     trial) by 2 interventions: reduce the risk of graft-versus-host disease (GVHD) and improve     the efficacy of the procedure decreasing the risk of relapses after transplant.      Currently, the standard approach used in most centers to prevent graft-versus-host disease     after allogeneic transplantation is based on the combination of a calcineurin inhibitor     (cyclosporine or tacrolimus) plus a short course of methotrexate. Unfortunately, this     strategy is far from ideal, since the risk of acute GVHD is in the range of 30-40% among     patients receiving a matched related donor transplantation and even higher among patients     receiving transplantation from an unrelated donor while the incidence of chronic GVHD is     60-70% among patients receiving peripheral blood progenitor cells from either a related or     unrelated donor.      As far as the patients with multiple myeloma (MM) is concerned, although the development of     new drugs has markedly changed the outcome and management of these patients, allogeneic     transplantation so far appears to be the only curative option, especially among those     patients relapsing after first line treatment. Nevertheless, still new strategies within the     allogeneic transplant setting are needed to improve its results.      Relapses may occur either extramedullary (very common in this setting) or systemic. In order     to reduce the risk of systemic relapses the investigators will use maintenance therapy with     Lenalidomide (Len) which, together with bortezomib (Bz) should contribute to eradicate     minimal residual disease (MRD). In case the patient do not obtain complete remission or near     complete remission after transplant, in addition to the maintenance therapy, the     investigators will use four intensification cycles with VRD (Bz-Len-Dexamethasone).      In summary, the goal is to optimize the efficacy of allogeneic transplantation by two     interventions: one focused on reducing the risk of relapse and the other on reducing the     incidence of GVHD.   "
139371|NCT01460407|"     The study will evaluate the effect of Clarithromycin on the pharmacokinetics (PK) of     LY2216684 in healthy participants. Side effects will be documented. There will be 2 study     periods (5 and 9 days) and follow up will occur at least 7 days after the last dose.     Screening is required within 45 days prior to the start of the study.   "
139372|NCT01460394|"     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in     two age groups: adolescents and young adults.   "
139373|NCT01460381|"     The study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine     on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be     documented.   "
139581|NCT01457664|"     This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in     healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of     RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.   "
139374|NCT01460368|"     Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects     due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.      Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose     level much higher than what would normally be given, on the electrical activity of the heart     as measured by ECG in relation to placebo and moxifloxacin.   "
139375|NCT01460355|"     Two different treatments were given to large angle horizontal strabismus (eso and exotropia)     adult patients who agree to participate of the study. Inform consents were required for     participants. Group 1 (12 patients) received conventional recess-resect surgery plus     intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only     conventional recess-resect surgery. The patients were randomly located in one of the groups.     The angles of horizontal deviation were compared between the groups before and six months     after treatment.   "
139376|NCT01460342|"     This is a phase 3, randomized, double-blind, placebo-controlled, parallel-design,     multinational study to evaluate the efficacy and safety of tadalafil once-a-day dosing for 12     weeks in Asian men with signs and symptoms of benign prostatic hyperplasia.   "
139377|NCT01460329|"     The purpose of this study is to compare the accuracy and precision of two non-invasive     methods of measuring cardiac output in critically ill children (<18 yrs). The participants     will include any patient admitted to Pediatric intensive care unit (PICU) requiring a     trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent     cardiac output will be obtained and compared on participants using standard 2-D TTE and     Ultrasound Cardiac Output Monitor (USCOM).   "
139378|NCT01460316|"     The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects     regarding the relations between the metabolic, the genetic and the environmental factors     which lead to these cardiopathy.   "
139379|NCT01460303|"     Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are     sometimes temporarily unable to empty their bladders and are sent home with a transurethral     indwelling catheter attached to a bag which holds urine. The goal of this study is to compare     a new type of patient-operated catheter without a bag to the catheter with a bag for ease of     use, comfort and quality of life for patients during the postoperative recovery period. This     new catheter, the OPTION-vf, is approved by the FDA and is available on the market.   "
139416|NCT01459822|"     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and     treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which     regulate mRNA expression. The present study was designed to observe the selected miRNA     expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a     new target for the treatment of sepsis.   "
149133|NCT01332071|"     The study is prospective, open-label, randomized, crossover, with 02 treatments, 02     sequences, and 02 periods. The volunteers received, in each period, the reference or the test     formulation after standardized meals.   "
139380|NCT01460290|"     Objectives: The investigators propose a first-ever, prospective trial of asenapine in older     adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and     functional/general health status. Given the dearth of treatment data on older adults with BD,     findings are likely to be of substantial clinical interest, may inform larger future studies     and will assist in refining bipolar treatment recommendations.      Hypotheses:      Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive     symptoms in older adults with BD.      Secondary: Asenapine therapy will be associated with improved functional and general health     status, improved global psychopathology, and good tolerability in older adults with BD.   "
139381|NCT01460277|"     The purpose of this current prospective study is to assess and compare the effects of a     hydrotherapy exercise programme against a conventional land-based exercise programme in     individuals with hemiplegia. Both exercise interventions aim at improving posture, balance     and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional     therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and     >60 years). The physical examination consisted of (1) a lower-limb motor function recovery of     the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb     strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and     plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified     Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural     control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional     status measured with the Functional Independence Measure. Postural sway was evaluated with a     pressure platform by using the variables of center of pressure (COP) displacements in the     mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and     evaluated using statistical programme SPSS.   "
139382|NCT01460264|"     This is an observational study aiming to identify and validate biomarkers (including imaging     and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular     disease (CVD) and lung cancer.   "
139383|NCT01460251|"     The study is an open-label extension study, offering patients who participated and completed     previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and     clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety     and efficacy data of long term treatment effect of Diapep277.Only patients who completed     studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L     will be eligible for this extension study   "
139384|NCT01460238|"     The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic     Leukemia (CLL) cells will predict a more aggressive clinical course. The results from this     proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL     and will predict CLL patients that have a more aggressive form of the disease. The     investigators work will also provide direct evidence that LPL is expressed on CLL cells and     provides a critical source of fatty acids required by the CLL cells to grow and survive.     Fatty acid metabolism may become a therapeutic target in CLL in the future.   "
139385|NCT01460225|"     This prospective study is designed to evaluate how lubiprostone may affect gastric motor and     sensory function.   "
139386|NCT01460212|"     Study hypothesis: psychotherapy and SSRI treatment effect in different brain way:     psychotherapy in up to down way and SSRI in down to up way. The investigators will     explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance     Imaging analysis in this study. Patients in different groups will be treated by psychotherapy     or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12     weeks of treatment.   "
139387|NCT01460199|"     This study is being conducted to evaluate the safety and tolerability of treatment with     CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.   "
139388|NCT01460186|"     This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is     to identify germ line genetic factors that influence the risk of metastatic breast cancer.      1500 patients will be enrolled in this study. Blood samples will be collected after informed     consent and inclusion in the study.      Patients will be treated and followed according to the standards of their treating center.      They will be followed during at least 5 years every 6 months for 3 years then every year.   "
139389|NCT01460173|"     Driving simulator programmes are used under a wide range of conditions, and a correlation of     driving performance and real accident risks in patients with obstructive sleep apnoea     syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided     Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until today     there are no reference levels with regards to sex and age in existence. To define the     boundaries of normality age and sex reference values are to be generated and compared to     values of patients with OSAS.      50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will     perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as     well. A better differentiation of pathologic driving performance and response times of OSAS     patients should be possible with new reference levels.   "
139391|NCT01460147|"     The purpose of this study is to evaluate bone mineral density in adult subjects with     hemophilia versus a comparator population without hemophilia (non-hemophilia age- and     gender-matched database) by using the following diagnostic means: dual-energy X-ray     absorptiometry (DXA) scanning, clinical scales, quality of life (QOL) scales and biomarkers.     In addition to this osteoporosis study, hemophilic arthropathy of the knee with respect to     loss of knee cartilage will also be explored by using magnetic resonance imaging (MRI     substudy). No investigational product will be dispensed.   "
139392|NCT01460134|"     This is a study of CDX-1127, a therapy that targets the immune system and may act to promote     anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias     and lymphomas), as well as patients with select types of solid tumors.   "
139472|NCT01459094|"     The purpose of this study is to see if the absorption and distribution of a fixed-dose     Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food     by healthy volunteers.   "
139473|NCT01459081|"     The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in     treatment of influenza A and B virus infections in China.   "
139393|NCT01460121|"     The diagnosis and management of acute vertigo and dizziness is most of the time an easy task     for the general practitioner. However, following an acute vestibular disorder and very often     with no any overt cause, a considerable number of patients complain on chronic dizziness and     subjective disturbance of balance despite normal clinical and laboratory tests. Patients     describe that perceptual visual stimulus provoke or aggravate their symptoms that are     frequently accompanied by anxiety. These cases have been described in the medical literature     as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and Space     Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar to     vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as     benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable.      Because visual stimuli play a crucial role in space orientation and motion perception, it is     reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral     visual field (that is involved mainly in the perception of motion) could be of help in     patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso     Mental Balance Technology) developed to alleviate the feelings of dizziness.      Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!   "
139394|NCT01460108|"     The purpose of this study is to characterize the safety and efficacy of the AeriSeal System     in patients with advanced upper lobe predominant emphysema and significant collateral     ventilation as determined by the Chartis System.   "
139395|NCT01460095|"     Glycated haemoglobin (HbA1c) is the best surrogate of average blood glucose control in     diabetic patients. Large-scale studies in the USA and UK have demonstrated that lowering     HbA1c significantly reduces diabetes complications. Moreover, immediate feedback of HbA1c     measurement to patients improves control. However, HbA1c is unavailable in most parts of     Africa, a continent with one of the highest burden of diabetes. To translate these evidences,     the investigators will provide affordable access to HbA1c measurement and relevant education     in 2 African countries aiming significant improvement of diabetes control. The investigators     will develop with local health authorities, training and cost-recovery scheme for long-term     sustainability.   "
139396|NCT01460082|"     The purpose of the study is to determine a possible association between the clinical entity     of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients     with COPD.   "
139397|NCT01460069|"     The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on     psoriasis in a double-blinded, randomized placebo-controlled clinical trial.   "
139398|NCT01460056|"     This observational retrospective healthcare medical record review study is to evaluate and     differentiate the clinical characteristics and outcomes in peritoneal dialysis (PD) patients     with either endotoxin-associated sterile peritonitis (e-SP), bacterial peritonitis (BP) or no     peritonitis (NoP) over a 12-15 month period from dialysis clinics in The Netherlands,     Germany, Hungary, Portugal, and the United Kingdom (UK).      The primary study objectives are to:        -  Describe changes in the peritoneal membrane function and clinical outcomes over time          between e-SP, BP and NoP PD patients.        -  Describe and differentiate clinical characteristics during the acute clinical          presentation of e-SP and BP.      The secondary study objective is to:      - Generate a dataset that will facilitate post hoc exploratory hypothesis-generation related     to clinical and resource utilisation (RU) outcomes in association with e-SP.   "
139399|NCT01460043|"     The purpose of this study is to compare outcomes and quality-of-life issues in the treatment     of menorrhagia, this randomized double blind controlled trial compared homeopathy and     placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the     condition was performed during one pre-treatment and three treatment cycles. outcome measures     were bleeding days, intensity. average pads used during menstrual cycle, abdominal & back     pain, General health and overall satisfaction.   "
139400|NCT01460030|"     This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of     KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or     intractable primary hyperparathyroidism (PHPT).   "
139402|NCT01460004|"     The purpose of this study is:        -  To examine the effect of infra patellar strap treatment on the extent of pain and          jumping performance tasks in young male athletes diagnosed with patellar tendinopathy.        -  40 elite male athletes, basketball and volleyball players, ages 14-18, students of the          academy for sports Excellency will take part in this study        -  Hypothesis 1: The treatment of infra patellar strap will reduce the level of pain during          jumping performance tasks.        -  Hypothesis 2: The treatment of infra patellar strap will improve the squat jump height          in athletes with patellar tendinopathy during squat jump task.        -  Hypothesis 3: The treatment of infra patellar strap will improve the drop jump height in          athletes with patellar tendinopathy during drop jump task.        -  Hypothesis 4: The treatment of infra patellar strap will improve the one leg jump height          in athletes with patellar tendinopathy during one leg jump task.        -  Hypothesis 5: The treatment of infra patellar strap will improve the 30 seconds          repetitive jumps mean height in athletes with patellar tendinopathy during 30 seconds          repetitive jumps task.   "
139403|NCT01459991|"     Purpose: During lactation, several physiological modifications occur including cellular     differentiation and proliferation, as well as elevation in inflammation. The role of the     Mediterranean (MED) diet rich in walnuts has been shown to favorably modify fatty acid     profiles and to reduce inflammation. The study goal is to evaluate the anti-inflammatory     effects of the MED diet rich in walnuts during lactation, a time of increased inflammatory     response.      Procedures: A randomized, controlled dietary intervention trial among lactating women     comparing the effects of a Mediterranean-style diet with walnuts to the USDA's MyPyramid Diet     for Moms was commenced to determine the effects of the diet on fatty acid profiles and     biomarkers of inflammation in breast milk and material serum/plasma. Secondary outcomes of     interest include effects of maternal diet assignment on maternal body weight and body     composition as well as infants' growth and health during the study trial period.      Population: The study population includes healthy women between the ages of 18-40 years who     are within 6 months post-partum and plan to breastfeed a minimum of 3 times per day for 6     months following study entry. There have been a total of 138 participants enrolled in the     study. All 138 participants are women; 34 identified themselves as Hispanic, and 104 said     they were not Hispanic.   "
139404|NCT01459978|"     Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative     Sum) will increase the awareness of health care staff in maternity and permit rapid detection     of a small dip in performance in order to enable prompt investigations and corrective     measures when necessary , which decrease maternal and neonatal mortality and morbidity.      Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity     dashboard to decreases maternal and neonatal mortality and morbidity.      Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.      Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants     could be collected over 2 year's period.      Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators     previously selected by Delphi method.      Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality,     adverse outcomes for women and newborn.   "
139405|NCT01459965|"     Endoscopic stent insertion is considered the method of choice for palliation of malignant     bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent     exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or     refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic     stenting for this relative indication might be justified, if there is a significant     improvement in quality of life (QOL) of such patients. The aim of the investigators study was     to determine whether endoscopic stenting for MBDO results in improved QOL.   "
139406|NCT01459952|"     The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase     III study.      After the patient has receiving information about the study and after given written informed     consent, the patient will be screened.      The patient's medical history and demographic information will be recorded. The patient will     then be asked questions in accordance to the study questionnaires, and they will also be     asked to complete questionnaires regarding quality of life - and finally they be instructed     on how to complete the diary.      All patients are randomized to receive standardized rose hip liquid or matching placebo. The     subject is instructed to take the liquid form of rose hips in the morning and evening meal.     The subject will also be advised to call the clinic if there is an acute attack of cold and /     or flu because they must then increase the in-take of study treatment to 3 double dose for 5     days and then return to normal dose.      The subject will then be asked a series of questions under study questionnaires, and be     instructed in how questionnaires (SF-12) and diary filled. This is to provide security to the     validation output values Investigator or study nurse will take telephone contact with the     subject once a month, subjects will be asked about how things are going and to remember to     take the liquid and whether they have completed the diary.      The last patient visit will take place after 6 months. Any side effects will be reported to     and reviewed with HybenVital ApS in collaboration with medical experts.   "
139407|NCT01459939|"     The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase     III study.      After the patient has receiving information about the study and after given written informed     consent, the patient will be screened. All patients are randomized to receive standardized     rose hip powder or matching placebo for 3 weeks followed by half the dose standardized rose     hip (or placebo) for the remaining 12 weeks of the study.      The patient's medical history and demographic information will be recorded. The patient will     then be asked questions in accordance to the study questionnaires, and they will also be     asked to complete questionnaires regarding quality of life - and finally they be instructed     on how to complete the diary.      Investigator or study nurse will take telephone contact with the subject after 3 and 6 weeks     of treatment, subjects will be asked about how things are going and to remember to take the     capsules and whether they have completed the diary.      The contact taken after 6 weeks by phone is mainly to guide the subject on how complete the     questionnaires including VAS scales.      The last patient visit will take place after 12 weeks. Any side effects will be reported to     and reviewed with HybenVital ApS in collaboration with medical experts.   "
139408|NCT01459926|"     A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and     Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation   "
139409|NCT01459913|"     The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in     combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV)     (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC     genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV)     infection and will not have cirrhosis of the liver.   "
139410|NCT01459900|"     The purpose of this double blind, randomized and sham controlled study is to determine     whether renal denervation in terms of catheter based ablation in the renal arteries is     effective in lowering blood pressure in patients with treatment resistant hypertension. The     blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure     measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point     evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and     forearm plethysmography.   "
139411|NCT01459887|"     CD20, the protein which is expressed on the surface of all mature B cells, is active in many     B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL),     the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice,     Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP) is     still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric     monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases.     This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP     chemotherapy regimen compared with CHOP chemotherapy alone.   "
139412|NCT01459874|"     The purpose of the registry is to evaluate an organizational model fixing roles and behaviors     of subjects involved in the remote monitoring of patients implanted with pacemakers and     defibrillators.      The evaluation will estimate the clinical efficiency and the impact on health service     resources of the organizational model when this is implemented in the daily clinical     practice.   "
139413|NCT01459861|"     The purpose of this study is to assess early ambulation following total knee replacement in     patients receiving continuous adductor canal block with posterior capsular injection compared     to continuous femoral nerve block with tibial nerve block.   "
139417|NCT01459809|"     Primary Objective:      - To demonstrate the superiority of glimepiride and metformin free combination in comparison     to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment     period in patients with type 2 diabetes mellitus.      Secondary Objectives:      - To assess the effects of the free combination of glimepiride and metformin in comparison to     glimepiride or metformin alone on:        -  Percentage of patients reaching HbA1c < 7%        -  Percentage of patients reaching HbA1c < 6.5%        -  Fasting Plasma Glucose (FPG)        -  Safety and tolerability   "
139418|NCT01459796|"     The purpose of this study was to determine the safety and tolerability of rilonacept for     participants with gout who were initiating allopurinol.   "
139419|NCT01459783|"     Dementia is a condition that is growing in prevalence and which harms not only the afflicted     individual but also adversely affects the health of their family and other informal     caregivers. New methods for delivering comprehensive assistance to persons with dementia and     their caregivers are known to be effective and can delay nursing home placement, but this     study will discover 1) whether more face-to-face involvement rather than telephone delivery     of this assistance will work better among poor patients in Los Angeles, and 2) if one method     is better than the other, what are the differences in costs between them. These data will     enable administrators in public health care settings around the US and non-profit foundations     addressing dementia patient and caregiver needs to decide what method provides the best value     and the best outcome relative to its cost.   "
139420|NCT01459770|"     Transitional care strategies focused on enhancing the accuracy and comprehensiveness of     medication information transfer will lead to improved health outcomes among hospitalized     patients with chronic kidney disease.   "
139421|NCT01459757|"     Retrospective correlation of clinical outcomes data with mutational status in GIST subjects     treated with sunitinib.   "
139422|NCT01459744|"     An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to     monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when     necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of heart     failure or other diseases. As patients near the end of life, physiologic changes (intrinsic     and extrinsic to the heart) may affect the cardiac conduction system, leading to more     arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and     anxiety and may not prolong a life of acceptable quality, it is appropriate to consider     deactivating the shocking function of ICDs as patients' clinical status worsens and death is     near. This will be a randomized controlled trial of a physician centered counseling and     education intervention to improve clinician-patient communication about the management of     ICDs.   "
139423|NCT01459731|"     Collect OCT data to evaluate the range and age trend of eye measurements.   "
139424|NCT01459718|"     The primary efficacy endpoint of this interventional study is to evaluate the number of     patients achieving a complete response (CR), defined as patients switching from intensive     deferasirox -DFO treatment, at any time point during the 24 months of study, to deferasirox     monotherapy based on improvement in the cardiac magnetic resonance imaging (MRI) T2* value to     >10ms, and continue to maintain their MRI T2* to values >10 msec.   "
139596|NCT01457469|"     This randomized clinical trial studies enhanced quitline intervention in smoking cessation     for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may     help patients with early-stage cancer quit smoking   "
139425|NCT01459705|"     This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing     it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post     traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The     investigators will test the general hypothesis that 10 sessions of VRET or PE will     successfully treat PTSD, therapeutically affect levels of physiological arousal, and     significantly reduce perceptions of stigma toward seeking behavioral health services.   "
139426|NCT01459692|"     Neurologically-impaired individuals may have significant neurologic morbidity related to     epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures, and     potentially reversing the epileptogenic process, is of paramount importance in improving the     lives of those with epilepsy. During a 3-year randomized, pilot clinical trial, twenty-seven     subjects were randomly assigned to receive nightly exposure to music at periodic intervals     between the hours of 9:00 PM and 8:00 AM. A significant effect was observed from the auditory     stimulus exposure (p<0.006).   "
139427|NCT01459679|"     The objectives of this study are to evaluate and compare the safety and efficacy of three     treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin     ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing     maximum corneal curvature.   "
139428|NCT01459666|"     Evaluate the efficacy and safety of using aboBTX-A to improve wound healing prior to Mohs     micrographic surgery and reconstruction for skin cancer of the forehead   "
139429|NCT01459653|"     This international, prospective, observational, open-label, pharmaco-epidemiologic study     observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are     receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better     describe the patient population at risk for FN and treated prophylactically in physician's     best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns     involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability     in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and     mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor     response to FN prophylaxis and experience break-through episodes of FN, understand the     differences between prophylaxis responders and non-responders, and describe the degree to     which prophylaxis of FN is in congruence with guideline recommendations.   "
139474|NCT01459068|"     The aim of the study is to determine the effectiveness of a transdiagnostic psychotherapy     intervention - namely, Common Elements Treatment Approach (CETA) - in reducing the severity     of mental health symptoms experienced by torture and violence survivors displaced from Burma     into Thailand. Specifically, the intervention seeks to measure reductions (if any) in     symptoms of depression and trauma.   "
140998|NCT01438957|"     The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine)     in patients who require sedation during the surgery that requires epidural or spinal     anesthesia without intubation under monitored sedation care.   "
139430|NCT01459640|"     Osteoarthritis is a progressively degenerative disease resulting in increasing pain,     impairment and ultimately disability. While the available treatments seek to ameliorate pain     or improve mobility, these treatments rarely modify the course of the disease, but rather     attend to its consequences. For early stage osteoarthritis, treatment is largely limited to     addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs).     These drugs do not stop the progression of the condition or regenerates damaged cartilage.      This is a randomized and open labelled study aimed to determine the efficacy of     intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in     patients with mild to moderate osteoarthritis.   "
139431|NCT01459627|"     OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet     therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation     Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes     (composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major     bleeding at 18 months after randomization).      The trial will incorporate two registers studying respectively the safety outcomes of     Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30     days. Finally the trial design permits assessment of the clinical outcomes after primary PCI     for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent     at 30 days and 6 months.   "
139432|NCT01459614|"     Primary Objectives      To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with     cisplatin in subjects with metastatic pancreatic cancer based on the progression-free     survival (PFS) rate at 6 month.      Secondary Objectives        -  To assess safety and characterize toxicities of the combination of GTX with cisplatin in          subjects with metastatic pancreatic cancer.        -  To estimate 3, 6, 9, 12, 15, and 18 month disease control rate (DCR), PFS, and overall          survival (OS).      Study Design      This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in     subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be     enrolled, 28 in the initial cohort and 10 in the expansion cohort      The study will have a safety run-in phase consisting of 6 subjects. To ensure that the     combination is safe, the first six subjects will be treated at DL1 and observed for limiting     toxicity for the first 2 cycles before continuation with further accrual. After the safety     run-in, the study will be continuously monitored for adverse events.      The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of     subjects alive, free of disease progression at 6 months. The treatment regimen would be     considered of insufficient activity for further study in this population if PFS rate at 6     months is 50% or less, and the minimum required level of efficacy that would warrant further     study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes     interim monitoring for futility using a predictive probability approach. We will stop the     study early if given the information at the interim analysis, it is unlikely that the PFS     rate at 6 months will be greater than 50% if the study continues to the end.   "
139433|NCT01459601|"     Diabetic patients with poorly control blood sugar are prescribed cabergoline for 1 months and     their blood glucose is evaluated.   "
139434|NCT01459588|"     This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation     in subjects with dry eye disease.   "
139435|NCT01459575|"     This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy     of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese     resource-limited setting.   "
139436|NCT01459562|"     The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic     profiles of a novel therapeutic drug when administered to healthy volunteers.   "
139437|NCT01459549|"     The purpose of this study is to determine whether Roux-en-Y choledochojejunostomy is a more     effective treatment for the hepatolithiasis patients accompanied with Sphincter of Oddi     Loose.   "
139597|NCT01457456|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Morquio     disease from plasma   "
139438|NCT01459536|"     Adequate upper limb function is critically important to maintenance of independence and     prevention of disability in older adults. The goal of this work is to identify factors that     contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the     investigators seek to identify patients most at risk for rupture and to guide clinicians on     optimal surgical and rehabilitation strategies. This pilot study will quantitatively     characterize the morphological (muscle volume and fatty infiltration) and functional     (shoulder isometric joint strength, movement when performing typical task) changes in the     muscles of the rotator cuff following supraspinatus tear and surgical repair. The     investigators hypothesize that patients with supraspinatus tear will have reduced muscle     volume and increased fatty infiltration of rotator cuff muscles compared to their     contralateral arm and age-matched controls, which will increase following surgery. The     investigators further hypothesize that isometric joint strength in these individuals will be     associated with muscle volume and the degree of fatty infiltration, and that older adults     with a rotator cuff tear will use a restricted range of motion to accomplish functional     tasks. This study emphasizes muscle function and composition with application to     rehabilitation of upper limb function, which complements the theme of the Pepper Center.   "
139439|NCT01459523|"     Continuous peripheral nerve blocks (CPNB; also known as perineural catheters) provide     target-specific pain control for a variety of surgeries. There has been increasing interest     in the use of ultrasound guidance for regional anesthesia, and many techniques using     ultrasound alone for perineural catheter insertion have been described. Catheters may be     placed at various points along the brachial plexus (for upper extremity procedures) or in     proximity to the femoral and/or sciatic nerve (for lower extremity procedures). To date, the     optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement     location per indication, for the majority of ultrasound-guided continuous peripheral nerve     blocks remain unknown. This study will help provide important information related to optimal     ultrasound scanning techniques and will help identify ways to improve the success rates,     onset times, and analgesic effectiveness of these techniques for real patients undergoing     surgical procedures.   "
140999|NCT01438944|"     Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine     receptor up-regulation through an observational study using nicotine replacement therapy for     two weeks and no intervention for two weeks.   "
139440|NCT01459510|"     The American Academy of Pediatrics recommends that parents receive anticipatory guidance     about how to discipline their children as part of the well child visit. However, physicians     provide counseling only 25-40% of the time. In regard to the type of discipline, the AAP     recommends that primary care providers encourage parent to use non-physical forms of     discipline and discourage parents from using physical punishment. Educational resources are     needed to help physicians routinely provide these important anticipatory guidance messages.     In this study, consecutive parents were exposed to routine anticipatory guidance messages     before the well child visit with the physician. After the clinic visit, parents were invited     to participate in a research study to assess their attitudes about physical punishment and     other discipline strategies. The key research question of this study is: Can a brief     multimedia program (i.e. Play Nicely program) affect parents' attitudes about the use of     physical punishment? The time frame of the study was June through August of 2010. Data was     collected immediately after the clinic visit and 2-4 weeks post clinic visit.   "
139441|NCT01459497|"     The study is designed to determine whether an accelerated course of hypofractionated     radiation therapy with daily image guidance and motion assessment/control will allow more     effective treatment of poor performance status patients with stage II-III NSCLC, who would     benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per     fraction).   "
139442|NCT01459484|"     The main objective of the study is to assess the survival in patient with non metastatic     osteosarcoma of the extremities treated with different chemotherapy protocols, according to     the expression of ABCB1/P-glycoprotein   "
139443|NCT01459471|"     The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative     complications. Staple line reinforcement (SLR) is strongly advocated.   "
139444|NCT01459458|"     This is a community-based participatory study to test a brief intervention to reduce risk for     intimate partner violence (IPV) and associated unintended pregnancy among young, medically     underserved women attending family planning (FP) clinics. Women ages 16-29 years utilizing FP     clinics report higher rates of IPV compared to their same-age peers, experiences associated     with unintended pregnancy. A critical mechanism connecting IPV with poor reproductive health     is abusive partners' control of women's reproduction through condom refusal, pressuring women     to get pregnant, and birth control sabotage, a phenomenon described as reproductive coercion.     In the investigative team's pilot intervention study 53% of young women using FP clinics     reported ever experiencing IPV, and 25% reported reproductive coercion, the combination of     which was strongly associated with unintended pregnancy. The proposed reproductive     coercion/partner violence intervention was developed collaboratively by community-based     practitioners, advocates, and researchers, with significant input from FP clients. Designed     to be implemented within routine FP care, maximizing feasibility and sustainability of this     program, the intervention provides 1) client education and assessment regarding IPV and     reproductive coercion; 2) discussion of harm reduction behaviors to reduce risk for     unintended pregnancy and IPV victimization, and 3) supported referrals to IPV victim     services. This is a full-scale RCT to assess the effects of this innovative program on IPV,     reproductive coercion and unintended pregnancy, major health threats for medically     underserved women. Evaluation of this intervention will involve random assignment of 25 FP     clinics (unit of randomization) in Western PA to either intervention or control (i.e.,     standard-of-care) conditions. Female FP clients ages 16-29 (N=3600) will be assessed at     baseline, 12-20 weeks (FU1), and 12 months (FU2) to assess intervention effects on knowledge     and behaviors related to IPV, reproductive coercion and related harm reduction, as well as     unintended pregnancy. Data will be collected via audio computer-assisted self-interview in     English or Spanish. Chart extraction will track clinic utilization, pregnancy testing, and     diagnosed pregnancies. Regression models appropriate for longitudinal data from     cluster-randomized trials will be used to estimate intervention effects.   "
139445|NCT01459445|"     The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone     combined with metformin and weight loss by means of dietary intervention on the indices of     endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum     hsCRP,lipids,insulin resistance and body composition in young women with PCOS.   "
139446|NCT01459432|"     The main purpose of this study is to evaluate the duration of immunity after a booster dose     of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does     seroprotection persist beyond teenage years and into the early twenties? This is the age     group which is most likely to carry the organism and to transmit it to other members of the     population. If a booster dose of MenC vaccine given to adolescents does produce protective     levels of antibody which persist into early adulthood, this would strengthen the case for     such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a     resurgence of the disease in the future.   "
139598|NCT01457443|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Pompe     disease from plasma.   "
139447|NCT01459419|"     The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is     justified on the basis of scientific and medical reasons. There are data in multiple animal     models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and     induces regulatory T cells and immune-modulation as desired in clinical studies. These     observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone     induced the desired immune-modulation in terms of immunological markers for regulatory T     cells and appropriate rises and declines in certain cytokine levels.   "
139448|NCT01459406|"     Some carbohydrates, particularly fructose, the sugar found in fruit and bread may cause     bloating, pain and erratic bowel habits (diarrhoea and constipation) particularly in patients     suffering from the irritable bowel syndrome (IBS). This may be because they are not well     absorbed in the small intestine and cause water to be trapped in the bowel causing     distension. Studies have shown that reducing the amount of these sugars in the diet can     relieve these symptoms. There is some evidence that combining fructose and glucose can reduce     the symptoms caused by fructose but just why is unclear. In this study, the investigators     will use a non invasive medical imaging technique called magnetic resonance imaging (or     MRI) to look at the behaviour of drinks containing these sugars in the bowels of healthy     human volunteers.      The investigators will give four different drinks: one beverage consisting of a very well     absorbed sugar, glucose, another consisting of the less well absorbed sugar fructose, a third     which is a mixture of glucose and fructose, and a fourth consisting of several fructose     subunits joined together (called fructan). The investigators will take MRI images of the     stomach and intestines at intervals for 5 hours and compare these with the feelings of     distension and bloating in our volunteers. The results will act as control for subsequent     studies in IBS patients and these may help design diets to reduce symptoms in IBS.   "
139449|NCT01459393|"     This study aims to compare in a prospective and randomized way actinic keratosis treatment     with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of     therapeutic efficacy, pain, and cosmetic results.   "
139450|NCT01459380|"     This phase I trial studies the side effects and the best dose of veliparib when given     together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab in     treating patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer     that has returned after previous treatment. Veliparib may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     pegylated liposomal doxorubicin hydrochloride and carboplatin, may stop the growth of tumor     cells by, either by killing the cells, by stopping them from dividing, or by stopping them     from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth by     blocking the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth     of tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving     veliparib together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and     bevacizumab may kill more tumor cells.   "
139451|NCT01459367|"     The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to     lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the     clinical dose.   "
139452|NCT01459354|"     Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable,     distressing sequelae after tracheal intubation. It was postulated that these effects are     because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to     improve visual field during intubation. This procedure might reduce laryngeal trauma during     intubation and therefore reduce the incidence or degree of post-operative sore throat. This     is the first prospective, double-blinded, controlled study, which is focused on the effects     of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).   "
139453|NCT01459341|"     Comparison of two non-invasive methods for measuring tissue oxygenation. One is     Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared     Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia     (CLI) undergoing invasive treatment (surgical or endovascular).   "
139454|NCT01459328|"     This is a prospective, multicentre, randomized clinical trial comparing two different     neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced     adenocarcinoma of the rectum.      This trial may establish the investigational therapy to be superior to, or at least not     inferior to conventional treatment.   "
139455|NCT01459315|"     The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid,     rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of     an investigational HIV medication known as GSK1349572 (dolutegravir).   "
139484|NCT01458938|"     The objective of this pilot study is to determine if degenerative spinal disorders such as     acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable     alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot     study shows a correlation between Substance P levels and pain associated with degenerative     spinal disorders, then a larger study will be initiated to determine the feasibility of using     Substance P levels in the diagnosis and treatment of degenerative spinal disease.   "
139457|NCT01459289|"     The use of HPV testing in cervical screening has raised concerns about the effect of a     positive HPV result on women's psychological well being. This is a nested psychosocial study     of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the     psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects     of educational intervention on such impact. Potential participants are identified among those     who have joint the COCY trial. Participants will be randomized into two groups, namely the     control group or intervention group. The control group participants will receive their smear     results and an HPV leaflet by post. The intervention group will receive the leaflet and a     counseling session on HPV. Self-administered questionnaires will be used to assess     participants' psychological condition at the receipt of the smear results and at two months     afterward. It is hypothesized that the level of emotional distress measured at smear result     notification will be greater than that at two months afterward for all participants.     Furthermore, participants in the intervention group will have lower psychological distress     than those in the control group at two months after the receipt of their smear results.   "
139458|NCT01459276|"     The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL     intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA     of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.   "
139459|NCT01459263|"     More than 25 percent of the general population suffers from varicose veins, which has a     considerable impact on quality of life. Nowadays endovenous treatment modalities for great     saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new     tumescent-less technique, that combines mechanical endothelial damage using a rotating wire     with the infusion of a liquid sclerosant. The current study aims at evaluating short and long     term outcome after mechanochemical endovenous ablation.   "
139460|NCT01459250|"     This study will assess the pharmacokinetics, safety and tolerability of a single dose of     AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease     with that in healthy matched control subjects.   "
139475|NCT01459055|"     Acrofacial vitiligo is a clinical form of vitiligo characterized by macules in distal digits,     periorificial-facial and ano-genital areas. Vitiligo European Task Force classifies vitiligo     as generalized or localized; generalized vitiligo may be further sub-divided into acrofacial,     vulgaris and universalis, and localized vitiligo, into segmental and focal. Some authors do     not believe that acrofacial is a real vitiligo clinical form, considering it as an initial     form of vulgaris vitiligo. The aim of this study is to follow early- diagnosed acrofacial     patients during ten years in order to define if these patients will maintain this clinical     form or will evolute to a more severe clinical form.   "
139476|NCT01459042|"     Recent studies indicate that primary aldosteronism (PA) is a much more common cause of     hypertension than had been demonstrated historically. In patients with resistant     hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has     been no such data in China, the investigators are conducting a PA study in different province     of China to evaluate the prevalence of PA in patients with resistant hypertension.   "
139461|NCT01459237|"     Background:        -  Cushing s disease can be caused by a tumor of the pituitary gland, a small gland about          the size of a pea located at the base of the brain. These tumors produce high levels of          hormones, which cause obesity, diabetes, and growth problems. The cure for this type of          Cushing s disease is to have surgery that removes the tumor but leaves the pituitary          gland alone. Currently, magnetic resonance imaging scans are the best way to find these          tumors. However, many of these tumors do not show up on the scan.        -  Positron emission tomography (PET) scans use radioactive chemicals to light up parts of          the body that are more active, such as tumors. Researchers want to try to make the small          Cushing s disease tumors more active to help them show up on the scans. A special          hormone will be given before the scan to make the tumors more active.      Objectives:      - To test the use of hormone stimulation to improve brain scans for Cushing s disease tumors.      Eligibility:      - Individuals at least 8 years of age who will be having surgery to remove Cushing s disease     tumors.      Design:        -  Participants will be screened with a medical history, physical exam, blood and urine          tests, and imaging studies.        -  They will have three brain scans before surgery. The first scan is a magnetic resonance          imaging scan to show a full picture of the brain. The second and third scans are PET          scans.        -  The first PET scan will be given without the special hormone. The second PET scan will          be done more than 24 hours but less than 14 days after the first PET scan. The second          PET scan will be given with the special hormone.        -  Participants will have tumor removal surgery through another study protocol.   "
139462|NCT01459224|"     Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at     diagnosis and initial treatment response assessment. At each time point (initial staging and     treatment response assessment) in addition to standard imaging investigations (PET CT, Chest     CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an     extended MRI scan.   "
139463|NCT01459211|"     The purpose of this study is to establish the safety and efficacy of a combination of     dexamethasone and lenalidomide (Revlimid®) (D+L) in subjects with relapsed or refractory CLL     who have failed or are unable to tolerate standard up-front therapy with regimens containing     Fludarabine or in those with mutations in the p53 gene, CAMPATH-1H.   "
139464|NCT01459198|"     Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract     illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and     pneumonia. RSV affects almost all children within the first 2 years of life. This study will     evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults,     RSV-seropositive children, and RSV-seronegative infants and children.   "
139465|NCT01459185|"     The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine     S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small     cell lung cancer. The investigators presume they can achieve high completion rate with low     toxicity.   "
139466|NCT01459172|"     The overall objective of this project is to determine the safety and breast tissue     bioavailability of limonene following massage application of limonene containing massage oil     to the breast.   "
139467|NCT01459159|"     This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in     Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q)     Myelodysplastic Syndrome (MDS).   "
139468|NCT01459146|"     The purpose of this study is to determine if Artemisinin-based Combination Therapy,     ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in     combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and     school sustained attention and concentration.   "
139469|NCT01459133|"     The purpose of this program is to allow patients with diabetes and with specific medical     needs which require them to use this investigational inhaled insulin product in order to     adequately manage their diabetes. Treatment use of this investigational product is only     anticipated when exceptional need is identified by a treating physician on a per patient case     by case review.   "
140050|NCT01451541|"     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group,     efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and     premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.   "
139470|NCT01459120|"     The purpose of this trial is to determine if door-to-door is more effective than community     gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural     Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of a     package of proposed services. The package consists of: Blood-pressure measurement,     blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up     vaccinations, deworming (children) Vitamin A (children & young women), family planning for     eligible women, Tuberculosis screening and HIV counseling and testing.   "
139471|NCT01459107|"     Background: Millions of people each year sustain injuries, have tumors surgically removed, or     are born with defects that require complex reconstructive surgeries to repair. In the case of     hand, forearm, or arm amputation, prostheses only provide less than optimal motor function     and no sensory feedback. However, hand and arm transplantation is a means to restore the     appearance, anatomy, and function of a native hand. Although over 70 hand transplants have     been performed to date and good functional results have been achieved, widespread clinical     use has been limited due to adverse effects of life-long and high-dose immunosuppression     needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems,     all of which can greatly affect recipients' quality of life, make the procedure riskier, and     jeopardize the potential benefits of hand transplantation.      Study Design: This non-randomized, Phase II clinical trial will document the use of a new     immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing hand     transplantation as a safe and effective reconstructive treatment for upper extremity     amputations by minimizing maintenance immunosuppression therapy in unilateral and bilateral     hand/forearm transplant patients. This protocol combines lymphocyte depletion with donor bone     marrow cell infusion and has enabled graft survival using low doses of a single     immunosuppressive drug followed by weaning of treatment. Initially designed for     living-related solid organ donation, this regimen has been adapted for use with grafts     donated by deceased donors. The investigators propose to perform 30 human hand transplants     employing this novel protocol.      Specific Aims: 1) To establish hand transplantation as a safe and effective reconstructive     strategy for the treatment of upper extremity amputations; 2) To reduce the risk of rejection     and enable allograft survival while minimizing the requirement for long-term high dose     multi-drug immunosuppression.      Significance of Research: Hand transplantation could help upper extremity amputees recover     functionality, self-esteem, and the capability to reintegrate into family and social life as     whole individuals. The protocol offers the potential for minimizing the morbidity of     maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this     life-enhancing procedure and enabling widespread clinical application of hand     transplantation.   "
139481|NCT01458977|"     This is a phase IV, multicenter, prospective, randomised, crossover, double blind,     placebo-controlled and proof of concept clinical trial.      All subjects fulfilling inclusion criteria will be randomised to add either TDF/FTC     co-formulation (group A) or placebo (Group B) to their current PI/r regimen, i.e.: DRV/r     800/100 mg QD or LPV/r 400/100 BID. This will be followed by a crossover addition of TDF/FTC     co-formulation or placebo.      Randomization will be centralised in the CRO FLS-Research Support and will be stratified by     DRV/r or LPV/r intake at baseline to ensure equal distribution in both arms. TDF/FTC     co-formulation or Placebo will be provided in a double-blinded fashion, i.e.: neither the     treating physician nor the patient will know whether the patient is receiving TDF/FTC or     placebo.      All subjects will receive dietary counselling to promote lipid-lowering diet provided by a     specialised dietician throughout the study.      The expected duration of the study for each participant will be 36 weeks. There will be 6     visits: screening, baseline and weeks 4, 12, 24 and 36.   "
139482|NCT01458964|"     Is quetiapine more effective than other medications in the treatment of fibromyalgia.   "
139483|NCT01458951|"     This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in     patients with moderate to severe ulcerative colitis who have failed or be intolerant to one     of following treatments for ulcerative colitis: oral steroids,     azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.   "
139580|NCT01457677|"     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will     investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major     depressive disorder having inadequate response to ongoing antidepressant treatment. Patients     will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching     placebo. The anticipated time on study treatment is 6 weeks.   "
139485|NCT01458925|"     Prospective, Single arm, Multi-Center        1. To establish the safety and preliminary efficacy of the Check-Cap System in patients          with negative FOBT (Fecal Occult Blood Test)        2. To collect data about the overall imaging of the colon internal surface during the          passage of the capsule        3. To develop a correlation map between the imaging of the polyps by optical colonoscopy          vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps by          CT Colonography [CTC] (in patients which were referred after positive CTC examination)   "
139486|NCT01458912|"     The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium     doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week     treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low     dose inhaled corticosteroid (ICS) therapy as demonstrated by a decrease in Forced Expiratory     Volume in one second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma     Control Questionnaire (ACQ)-6 score of not less than 1.5 at time of randomisation.   "
139487|NCT01458899|"     (Food versus no food) crossover study to measure the effects of food on pharmacokinetics of     TC-5214 (S-Mecamylamine) in healthy Subjects.   "
139488|NCT01458886|"     The aim of this study is to assess and compare efficacy and safety of BI 54903 at doses of     very low dose twice daily (b.i.d) and low dose once daily (evening dosing) and placebo over     an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled     on short acting beta-2 agonist (SABA) therapy alone as demonstrated by a decrease in forced     expiratory volume in 1 second (FEV1) (not less than 10 %, and equal to or less than 25%) and     an Asthma Control Questionnaire (ACQ-6) of not less than 1.5 at time of randomisation.   "
139489|NCT01458873|"     Vascular access in patients carries a significant risk of accidental extravasation of     intravenous (IV) fluids and medications with the potential for tissue injury. This     prospective controlled study assessed the diagnostic utility of using intravenous diluted     sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium     bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal     carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the     injected bicarbonate will dissolve into carbon dioxide and water and cause a transient     increase in the measured exhaled CO2.      The effect is unique to bicarbonate and will not appear once normal saline is injected. the     safety of the administration of bicarbonate on the metabolic profile of the volunteers will     be assessed by measurement of venous blood pH and electrolytes.   "
139490|NCT01458860|"     Atherosclerosis is the major contributor for the morbidity and mortality for the variety of     cardiovascular diseases.      Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent     prognostic factor for the morbidity and mortality from a cardiovascular event.      Carotid artery stenoses is the current accepted indication for interventional treatment of     carotid artery, for the prevention of embolic event, while other arterial atherosclerosis     indication, is for hemodynamic disturbance and ischemic outcome.      This research will try to find whether incidental aortic calcification can predict carotid     artery stenosis.      Two groups will be chosen: group A - patients who had CT scan in the hospital (for different     indications); Group B - patients (not from the first group) who have a significant carotid     artery stenosis who are indicated for interventional treatment.      The data to analyze:      Group A - Patients with aortic calcification, carotid artery stenosis, and patients with both     Group B - Patients who have aortic calcification Comparison of the populations within the     group and among the two will show if a significant correlation between aortic calcification     and carotid artery stenosis exist.   "
139491|NCT01458847|"     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of     intravesical cis-urocanic acid in patients with primary or recurrent non-muscle invasive     bladder cancer.   "
139514|NCT01458548|"     Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of     transplant recipients and can be EBV-associated. To improve long-term efficacy after     rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the     investigators initiated an international multicentre phase II trial to test whether the     subsequent application of rituximab and four courses of three-weekly CHOP would improve the     outcome of patients with PTLD: PTLD-1, sequential treatment (ST).   "
139515|NCT01458535|"     The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of     ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve     participants with genotype 1, 2 or 3 chronic HCV infection.   "
139492|NCT01458834|"     Several studies indicate that cigarette smokers show an attentional bias for     cigarette-related cues, meaning that they more quickly detect and attend to and have more     difficulty disengaging in cigarette-related information than neutral information. This bias     is associated with craving and relapse following attempts to quit. This experiment will     examine whether a computerized attentional training procedure will successfully reduce     attentional bias towards smoking cues and reduce craving in regular cigarette smokers. The     attentional training will be administered in a novel format in which participants complete     5-minute long training sessions 3 times per day and can complete the trainings via home     computer or handheld device such as the iPhone, Android phone, or iPod touch. A baseline     assessment in the laboratory will measure attentional bias to smoking cues and craving     following smoking cue exposure. Participants will then be randomly assigned to either the     active training condition or a control condition. In both conditions, participants will be     asked to complete brief training sessions 3 times daily for one week using their personal     computer or handheld device. Following one week of training, participants will return to the     lab for endpoint assessment of attentional bias and craving. The investigators hypothesize     that compared to the control condition, the active training condition will significantly     reduce attentional bias toward smoking related cues and cue-induced cigarette craving.   "
139493|NCT01458821|"     The purpose of this research study is to determine whether the Brain Fitness Program-Tinnitus     affects how tinnitus is perceived and if its use aids in the recovery of cognitive functions     that may be affected by tinnitus. The investigators hope to better understand areas of the     brain involved with or changed because of tinnitus. The investigators also hope to see if the     Brain Fitness Program-Tinnitus impacts changes in those areas of the brain the investigators     believe may be affected by tinnitus.   "
139494|NCT01458808|"     Objective: To evaluate the influence of dietary sodium reduction on body fluid volume and     inflammatory state in hemodialysis (HD) patients.      Design: Prospective controlled randomized study. Setting: Dialysis Unit of Botucatu Medical     School Hospital, Sao Paulo State University, Brazil.      Patients: Adult patients on HD for at least 30 days and C-reactive protein (CRP) ≥ 0.7 mg/dl     were randomly allocated into two groups: Group A: 21 patients treated with a 2g sodium     restriction in their habitual diet, and Group B: 18 controls. Inflammatory, biochemical,     hematological and nutritional markers, as well as dialysis dosage were assessed at baseline     and after 8 and 16 weeks.   "
139495|NCT01458795|"     The aim of this study is to evaluate the morphologic and hemodynamic changes in the calf     perforators after endovenous laser ablation of saphenous veins.   "
139496|NCT01458782|"     ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte     Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of     cartilage defects in the knee.      Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are     planned to include in this study.      Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI     includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in     Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the     ChondroGide membrane.      The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture     and cover of the defect using the same ChondroGide membrane.      In both groups stitches and fibrin glue will be used to fix the membrane.      Inclusion criteria:      Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size     more than 2 square cm.      Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint     disease, Serious illness      Preoperative examination and follow up: Clinical examination and registration of KOOS (a     validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of     the involved knee including weightbearing standing radiographs of both knees. Kellgren-     Lawrence classification will be used for grading of OA.      Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients     having a new cartilage resurfacing operation or prosthesis will be listed as failures of the     initial treatment.      Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for     the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive cell     cultivation and two surgeries).      Data will be analyzed using the SPSS statistical package.   "
139497|NCT01458769|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     isotopologs of Atazanavir both as single agents and as combinations.   "
139498|NCT01458756|"     Organ transplantation has a special place in the medical field. It symbolizes a medicine     whose limits always seem to be repelled. Because transplantation is unusual, it places people     in front of outstanding issues which he has to cope with his personality and history. Factors     involved in the psychology of patient presenting with graft are past and present psychic     functioning, object relations, experience of transplantation itself and quality of social     environment.      Before or after graft defense mechanisms can be so intense that they can make the patient     unable to overcome the graft. Yet as a pathological mechanism that denial was considered     beneficial provided it is short.      The aim of this study is to evaluate on psychopathological influence of psychological defense     mechanisms used by liver transplant patients on their somatic psychological and social     outcome.   "
139499|NCT01458743|"     The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of     ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.   "
139500|NCT01458730|"     The purpose of the study is to test the efficacy and tolerability of a multiagent     chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma     in the brain.   "
139501|NCT01458717|"     Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline     resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III     study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable     pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with     neoadjuvant chemoradiation therapy.   "
139502|NCT01458704|"     Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome     sequencing) will be performed from fresh frozen tumor samples to understand the genetic     alteration of tumors and to aid in optimal selection of further therapeutic agents.   "
139503|NCT01458691|"     The purpose of this study is to compare the efficacy of intra-articular allogenic Platelet     Rich Plasma injection and steroid injection in the treatment of adhesive capsulitis of the     shoulder.   "
139540|NCT01458197|"     1. Primary Objective:           To evaluate the dose-response relationship of tarafenacin on efficacy.        2. Secondary Objectives:             -  To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo               in patients suffering from Overactive Bladder. .             -  To compare the tolerability of different doses of tarafenacin to that of placebo in               patients suffering from Overactive Bladder. .   "
139504|NCT01458678|"     Goal directed volume therapy means that bolus doses of 150-250 ml colloid fluid is     administered to the patient during contemporary measurement of the patients stroke volume.     The fluid status is considered optimized when stroke volume no longer increases with more     than 10%, indicating that the patient is close to the top of the Frank-Starling curve.     Several studies show that volume optimization reduces hospital stay and reduces the amount of     surgical complications. The overall purpose is to investigate if the much more simple non     invasive technique Pleth Variability Index can replace oesophageal doppler to guide volume     therapy in routine health care, and to analyse if a volume kinetic test can be used to     evaluate hypovolemia before surgery and make specific rehydration possible by analysing the     correlation between this test and fluid optimization using stroke volume measurements.      Primary hypothesis: 1. The volume of colloids that is given to volume optimise an     anesthetized patient using Pleth Variability Index shows a good correlation to the volume     used if volume optimisation is undertaken by the guidance of oesophageal doppler. 2. Data     from the two methods correlate and discriminates similarly volume responders from non     responders. 3. A volume kinetic model that indicates dehydration can predict the need for     rehydration in order to achieve a well hydrated patient at start of surgery.   "
139505|NCT01458665|"     -  The purpose of this study is to compare the clinical and anatomical outcomes of rotator          cuff repair with Platelet-Rich Plasma (PRP) and conventional rotator cuff repair in          treatment of medium to large rotator cuff tears.        -  PRP application to arthroscopic rotator cuff repair would accelerate recovery after          arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall          satisfaction, and enhance structural integrity of repaired tendon.   "
139506|NCT01458652|"     Accumulating evidence suggested that increased oxidative stress (OxSt) as well as     inflammation are risk factors for cardiovascular events in hemodialysis patients. The     incremental effect of online haemodiafiltration (OL-HDF) on markers of microinflammation ,and     OxSt is less clear. Besides, the relationship between protein-bind uremic toxin and     microinflammation remains obscure. The aim of this study was to evaluate the effect volume     replacement of on-line hemodiafiltration on proinflammatory peripheral monocytes (percentage     of CD14+CD16+ cells), PAF, IL-6 and on the plasma level of several oxidative stress markers     as well as several protein-bound uremic toxins such as p-cresol, indole sulfate etc. In a     case controlled study, 30 patients on OL-HDF will be evaluated. The association between     protein-bound uremic toxins such as p-cresol, indole sulfate etc and AST-120, a spherical     adsorptive carbon preparation (Kremezin) will also being investigated.   "
139507|NCT01458639|"     Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA)     imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging     for the diagnosis of Pulmonary Embolism (PE).   "
140163|NCT01450059|"     The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed     Newborns after spontaneous birth in comparison to cesarean section.      This may have an influence on the risk of vertical HiV transmission.   "
139509|NCT01458613|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of     Maroteaux-Lamy dis-ease from plasma and sputum   "
139510|NCT01458600|"     AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease      Background - Already at diagnosis of Graves disease approximately 98% of the patients have     morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known     to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation     is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when     treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase     differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma     agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological     concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack     this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of     importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and     adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID     like diclofenac may affect both. There is only one earlier study demonstrating effects of     NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms     and eye protrusion.      Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of     ophthalmopathy.      Specific aims:        1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months          treatment with or without diclofenac.        2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy          after 12 months treatment with or without diclofenac.        3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months          treatment with or without diclofenac.      Study plan and randomisation -      150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with     anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18     months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12     months.   "
139511|NCT01458587|"     The purpose of this study is to determine if Levulan PDT is safe and effective in the     treatment of actinic keratoses on the upper arms and hands.   "
139512|NCT01458574|"     The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and     tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to     assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves     mucosal healing and improves quality of life in subjects with UC.The study proposes to assess     CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18     years with UC.   "
139513|NCT01458561|"     This is a prospective, multicenter, randomized, controlled investigation. Subjects in which     bleeding from the exposed parenchymal surface is observed intraoperatively following the     ligature of vessels visible with the unaided eye will be randomized to an adjunctive     application of BioFoam or a standard topical hemostatic agent (Gelfoam with thrombin, in the     form of Gelfoam Plus) to the entire exposed parenchymal surface. Following primary treatment     of the exposed parenchymal surface as prescribed by the randomization scheme, treatment sites     will be visually evaluated for the continued presence of bleeding. The overall objective of     this investigation is to collect clinical data concerning the safety and effectiveness of     BioFoam used as an adjunct to conservative measures of achieving hemostasis, such as manual     pressure, cautery, and ligation, for intraoperative capillary, arteriolar, and venular     bleeding (5 second stack of 5 gauze surface Bleeding Score = 1b or 2, score to be     validated) on newly resected liver parenchyma in hemodynamically stable (American College of     Surgeons' Advanced Trauma Life Support Class I Hemorrhage) and non-coagulopathic patients in     the open treatment of exposed liver parenchyma versus a standard topical hemostatic agent,     Gelfoam Plus. It is not intended for traumatic liver injury. The investigation will be     conducted at a maximum of three investigational sites.   "
140611|NCT01444040|"     Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices     versus medical therapy in eyes of subjects with primary open-angle glaucoma,     pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.   "
139516|NCT01458522|"     This a phase 2 study comparing the efficacy of intravenous (IV) lacosamide (LCM) with IV     fosphenytoin (fPHT) in controlling frequent nonconvulsive seizures (NCSs), the Adverse Events     profile of LCM compared with fPHT when used to treat frequent NCSs, and length of stay in an     intensive care unit for subjects treated with LCM versus subjects treated with fPHT. The     trial will include a preacute-treatment period, an acute-treatment period, a     postacute-treatment period, and a long-term follow-up period.   "
139528|NCT01458353|"     Despite performing colonic surgery with strict asepsia measures, minimizing the contact of     the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In     stapled anastomosis, the hole opened in the colon is minimum, just the necessary for     introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen     is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the     suture is performed.      Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than     after handsewn ones.   "
139529|NCT01458340|"     The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be     evaluated in adult males with ADHD.   "
139517|NCT01458509|"     It can be difficult to obtain the perspective of patients who have had bowel surgery. This     study is being done because the investigators are trying to find out whether patient-reported     outcomes, (results reported to investigators by the patient), on a regular basis, will help     the investigators provide better patient care and symptom management.      Therefore, the purpose of this study is to determine if it is possible and if it is useful to     their medical care for patients who have had bowel surgery to complete surveys about their     symptoms on a regular basis. In this study the surveys are completed from home, by web or by     telephone, every month for 6 months. The results of this study will guide the design of large     research studies on cancer-related bowel function.      The purpose of this study is to develop a bowel function questionnaire for patients with     colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel     function.   "
139518|NCT01458496|"     A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes)     but without pre-existing cardiovascular disease will effectively help participants change     their lifestyle behaviour and prevent or delay onset of cardiovascular disease.   "
139519|NCT01458483|"     The Acute Carotid Sinus Endovascular Stimulation II (ACES II) Study is a multicenter,     prospective, non-randomized study that is being conducted to evaluate the feasibility of     endovascular stimulation of carotid sinus nerves via an electrophysiology (EP) catheter     advanced into the internal jugular vein (IJV). The current study investigates the hypothesis     that intraoperative electrical stimulation of the carotid sinus from the IJV will result in     an acute and dose-dependent reduction in blood pressure and heart rate.   "
139520|NCT01458470|"     Huntington disease is characterized by difficulties in movement and thinking. Psychological     disturbances including irritability, aggression, loss of interest, depressed mood, obsessions     and compulsions, also represent common symptoms of HD. These symptoms are distressing both     for HD patients and their caregivers, contribute to the loss of ability to carry out     activities of daily living, and present a major treatment challenge for physicians. The goal     of this study is to determine the effect of memantine on movement, thinking and emotional     difficulties in HD patients. Memantine is a medication originally approved for the treatment     of aggression and agitation in patients with moderate-to-severe Alzheimer's disease (AD),     which has also recently been shown to improve the behavioural and neuropathological symptoms     in a mouse model of Huntington Disease (HD).   "
139521|NCT01458457|"     Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease     specific quality of life of an individualized additional complementary medicine treatment in     addition to usual care with usual care only in 280 women with breast cancer   "
139522|NCT01458444|"     The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place     in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the     use, in the immediate postoperative period, should lead to define the role of each technique     and lead to a optimal rationalization of patients management with acute respiratory failure     after surgery.   "
139523|NCT01458431|"     The postoperative period following cesarean is associated with moderate to severe pain that     requires a considerable amount of analgesics that carry with them side-effects such as     nausea, vomiting, fatigue and immobilization. Several studies have tried, with variable     results, to find a more effective analgesia alternative such as infusion of local anesthetics     through a catheter in the surgical wound sinus, a practice that has currently been widely     used in clinical practice. Despite existing references on its use in the postoperative period     following cesareans there continues to be a lack of information on other aspects. The     investigators study hypothesis is that the use of levobupivacaine in the surgical wound will     reduce the surface of hyperalgesia compared to the control group.   "
139524|NCT01458418|"     Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights infection)     travel to the esophagus (the tube through which food passes to the stomach). These cells do     not belong there and can cause pain, soreness, difficulty swallowing and sometimes vomiting.      Ways to treat this condition include medicine, not eating some foods, and drinking a specific     formula (like milk) without eating any other foods. Doing these things can help fight off EE     but these problems can come back when treatment is stopped. If EE symptoms go on for a long     time, it can lead to the esophagus becoming narrow and feeling tight when eating and     swallowing and surgery may be needed to widen the narrowed area to relieve the sensation of     tightening.      Montelukast is a medicine that fights off a type of chemical that can be a magnet for     eosinophils. People usually take this medicine to help treat their asthma. It is not approved     to treat EE. This medication is taken once a day.      The purpose of this study is to see if Montelukast, compared to placebo, will help reduce the     number of eosinophils in children with EE and help stop the tightening of the esophagus.   "
139525|NCT01458405|"     The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells     (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial     infarction.   "
139526|NCT01458392|"     Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied     in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks     the development of blood vessels that supply tumors.   "
139527|NCT01458366|"     The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to     define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of bendamustine,     ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma whose disease     has progressed or has recurred after prior chemotherapy.      The Phase II part of the study will be a single-arm, open-label study in which all patients     will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose     defined in phase I.      This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin's     Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The     hypothesis is that the proposed combination of chemotherapy is well-tolerated and is     efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.   "
139543|NCT01458158|"     The purpose of this study is to determine whether matrix metalloproteinases are associated     with atherosclerosis in the different stages of chronic kidney disease.   "
140546|NCT01444885|"     The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol)     in comparison with placebo for 4 weeks in vasospastic angina patients who have an     insufficient response to Amlodipine (Calcium channel blocker).   "
139530|NCT01458327|"     This study will consist of a single session of MDMA-assisted psychotherapy with a full dose     of MDMA for people who took part in a study of MDMA-assisted psychotherapy in people with     posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a     year after the first MDMA sessions. The single session will be performed by the same pair of     therapists who performed the sessions in the first study. People will have a preparatory     session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms     and symptoms of depression will be measured at the start of this study and two and 12 months     after the session.   "
139531|NCT01458314|"     Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory     insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies     performed in these patients during a unique session of training have shown a positive effect     on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during     incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI patients     with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV during arm     effort test improved ability to perform the exercise. Similar result was not reached using     NIV during walking. Further studies have underlined a positive effect of the ventilation     therapy during exercise within specific programs of pulmonary rehabilitation (Corner 2009).     Moreover, the addition of NIV to an exercise training (ET) program in COPD patients may     produce greater benefits in exercise tolerance and quality of life than exercise training     alone (Garrod 2000).      A great improvement in health-related quality of life, functional status and gas exchange in     COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with     patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008). However,     in the same study Duieverman did not show any significant difference between groups in terms     of tolerance to effort test.      Aim of the study is to evaluate if application of daily NIV during physical training may     increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with     patients with nocturnal NIV performing training under spontaneous breathing.   "
139532|NCT01458301|"     The purpose of this study is to determine the efficacy and safety of TAK-385, once daily     (QD), for 12 weeks in women with endometriosis.   "
139533|NCT01458288|"     This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell     Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma,     Non-Hodgkin Lymphoma or Hodgkin Disease.   "
139534|NCT01458275|"     This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group,     efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and     premenarchal female subjects 6 to 11 years-old diagnosed with SAR.   "
139535|NCT01458262|"     The purpose of this study is to determine the clinical impact of cerebral and systemic     desaturation during liver transplantation and resection on post-operative complications.   "
139536|NCT01458249|"     The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in     subjects with soft tissue sarcoma who received at least one standard chemotherapy (an     anthracycline or an ifosfamide monotherapy or a combination therapy).   "
139537|NCT01458236|"     A multinational, multicenter, double-blind, randomized, placebo-controlled, Phase III study     to assess the efficacy and safety of BPS 314d-MR in subjects with pulmonary arterial     hypertension currently receiving treatment with an Endothelin Receptor Antagonist (ERA)     and/or a Phosphodiesterase-5 Inhibitor (PDE-5 inhibitor).      Approximately 100 centers will be participating in the study. Approximately 630 eligible     subjects will be randomized 1:1 into two groups, BPS-314d-MR (active) or placebo study drug.   "
139538|NCT01458223|"     Post-operative antibiotics for infection prophylaxis are routinely given to most surgical     patients, and for orthopaedic surgery patients, the standard of care is treatment for 24     hours following any elective procedure (1). The most concerning risk for insufficient     antibiotic coverage in the post-operative period is the development of a complicated     infection requiring irrigation and debridement or revision surgery. Moreover, recovery from     surgery is usually delayed in patients that have postoperative wound infections leading to     increased resource utilization and increased economic cost for the health care system. It is     clear that prophylactic antibiotic therapy is necessary in the immediate post-operative     period, but the length required continues to be debated.      Orthopaedic patients undergoing elective spine surgeries often require the placement of a     hemovac drain which applies gentle suction to remove excess fluid/blood and to promote     healing. Wound drains, however, may also increase the risk of post-operative infection     because they expose the clean interior aspect of the wound to the dirty exterior area     around the wound. Given this additional focus of infection, it is unknown whether prolonged     antibiotic therapy post-operatively is needed to decrease the rate of infection in this     population (2,3). There is sparse literature evaluating the effectiveness of prolonged     antibiotic therapy in decreasing complicated post-operative infection requiring irrigation     and debridement in this population (1,4). To our knowledge, there are no recent studies     comparing prophylactic antibiotics for 24 hours only post-operatively versus 24 hours after     removal of the drain. In fact, a recent evidence-based review of the literature by the North     American Spine Society highlighted the need for research in this area (5).      The proposed study will compare two patient populations who will receive various lengths of     post-operative antibiotics. One will receive only 24 hours worth, and the other will receive     antibiotics for 72 hours after surgery and the rate of complicated infection compared between     the two.      The absence of a demonstrable difference suggests that antibiotic prophylaxis for only 24     hours immediately post-operatively is sufficient for all elective spine patients undergoing     posterior spine procedures requiring the placement of a hemovac drain.   "
139539|NCT01458210|"     The purpose of this study is to look at how the body processes oral contraceptive (OC), using     Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female     participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body.     Information about any side effects that may occur will also be collected.   "
139541|NCT01458184|"     The aim of this study is to assess the effectiveness of Telephone-Linked Care for Complex     Patients (TLC-C) in the care of patients with complex health care needs. These are patients     frequently transitioning from inpatient to ambulatory care with multiple chronic diseases     that tend to lead to increased health-care utilization and other socio-economic     vulnerabilities. The objective is to reduce preventable hospital utilization, improve quality     of life, increase satisfaction with ambulatory care, improve disease-specific metrics, and     reduce net payer costs.   "
139542|NCT01458171|"     The objective of this study is to assess the long-term safety, tolerability, and efficacy of     IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study     ZLB06_002CR (NCT01199705).   "
139544|NCT01458145|"     This is an efficacy study of an intensive home visitation intervention, Minding the Baby     (MTB). This reflective parenting program (aimed at enhancing maternal reflective capacities),     is focused on first-time young mothers and infants living in an urban community. The study,     grounded in attachment and human ecology theories integrates advanced practice nursing and     mental health care by pairing master's level nurse practitioners and social workers with     at-risk young families. Aims of the study are: 1) to determine the efficacy of the MTB     intervention in young mothers and infants with respect to a) maternal outcome variables     including the quality of the mother-infant relationship, maternal reflective capacities,     maternal mastery/self-efficacy, parental competence, and maternal health and life course     outcomes (educational success, employment, delaying subsequent child-bearing); and b) infant     outcome variables including early attachment, infant health, and developmental outcomes; 2)     to monitor fidelity and dose of the program with young mothers; 3) to describe the evolution     of reflective capacities in adolescent mothers (contrasting intervention group with control     group) through descriptive qualitative analyses of transcribed Pregnancy Interviews and     Parent Development Interviews at the last trimester of pregnancy and at 24 months; 4) to     conduct cost-effectiveness analyses of the program. The longitudinal two-group study     (subjects nested within randomly assigned groups), will include multi-method (self report,     interview and direct observation and coding of behaviors) approaches with a cohort of     first-time multi-ethnic mothers between the ages of 14-25 (and their infants). MTB home     visits occur weekly for intervention families (n=69) beginning in mid pregnancy and     continuing through the first year, and then bi-weekly through the second year. Mothers and     infants (n=69) in the control group will receive standard prenatal, postpartum and pediatric     primary care in one of two community health centers (as will the intervention group) and also     receive monthly educational materials about child health and development mailed to their     homes. Maternal and infant outcome variables will be followed over time (pregnancy, 4, 12,     and 24 months) as well as compared between the 2 groups. Cost analyses and analysis of the     dose and sample characteristics linked to efficacy, will allow us to plan for translation of     the model into clinical care and community sustainability.   "
139545|NCT01458132|"     The World Health Organization has estimated that as many as 10% of the population worldwide     may at some point experience at least one seizure. The percentage with active epilepsy is     from 0.4% to 1%. From 40% to 65% of patients with HIV infection have been estimated to have     some neurological involvement; the percentage reaches as high as 70% to 80% when post-mortem     assessments are included. Estimates of the percentage of HIV-infected patients with seizure     occurrence have varied widely, with one review finding a range from 2% to 20%. The highest     percentage in this range was reported at a center that exclusively treated patients with     neurological involvement, in India where HIV clade C subtype is predominant. Query of another     neurology department's database determined that of the HIV-infected patients treated at the     center, all of whom were referred for neurological symptoms, 6.1% experienced seizures.     Underlying neurologic diseases in these patients included HIV-associated encephalopathy,     progressive multifocal leukoencephalopathy, and toxoplasmosis. In a Spanish population, 3% of     HIV-infected patients over a one-year study period were found to have new-onset seizures,     which were attributed to drug toxicity in 47%, intracranial lesions in 35%, and metabolic     derangements in 12%.      Drug-discontinuation studies, magnetic resonance imaging studies, and animal studies have     produced recent evidence that some antiretroviral therapies may have neurotoxic effects,     warranting further research. Individuals who are treated with highly active antiretroviral     therapy are at risk for immune reconstitution inflammatory syndrome (IRIS), in which immune     recovery triggers clinical deterioration as the newly invigorated immune system reacts to     pathogens that either represent ongoing opportunistic infection or were previously     successfully controlled. In a population initiating combination antiretroviral therapy     between 1999 and 2007, 0.9% developed neurological manifestations of IRIS. Seizures may occur     as part of a neurological IRIS syndrome, such as encephalitis and toxoplasmosis.      Two randomized, Phase 2b dose-finding studies were conducted in HIV-1 infected adults to     compare GSK2248761 100 mg and 200 mg given once daily as part of an antiretroviral treatment     regimen. One of the studies (SGN113399) was in subjects with prior exposure to antiretroviral     therapy where GSK2248761 100 mg and 200 mg once daily were compared to determine the best     dose in this population. A contemporary control arm receiving etravirine 200 mg twice daily     was also included, and all arms included a twice-daily background therapy consisting of     darunavir/ritonavir 600 mg/100 mg plus raltegravir 400 mg. The other study (SGN113404) was in     treatment-naïve subjects, comparing GSK2248761 100 mg and 200 mg once daily to determine the     best dose in this population. A contemporary control arm receiving efavirenz 600 mg once     daily was also included, and all arms were given background therapy selected by investigators     from either once-daily abacavir/lamivudine 600 mg/300 mg or tenofovir/emtricitabine 300     mg/200 mg. Of a planned total population in both studies of 300 subjects, 35 were enrolled     before the studies were terminated because of the occurrence of seizures in five subjects.     All of the subjects who experienced seizures were enrolled into SGN113399, four randomized to     receive 200 mg GSK2248761 and one randomized to receive 100 mg GSK2248761. There were no     seizures in the subjects receiving GSK2248761 in study SGN113404. At the time of study     termination, subjects had been enrolled and received GSK2248761 at 19 sites in four     countries: France, Romania, United States, and Germany. Although potential contributory     conditions have been identified in some cases, definitive causative factors for the seizure     occurrence have not been established.      The purpose of this study is to follow subjects who previously received GSK2248761 while     enrolled in the Phase 2b studies, which were halted due to unexpected seizures. The study     will collect data on all subjects and will be used to monitor for additional seizures as well     as collect additional clinical data on all subjects.   "
139546|NCT01458119|"     This is a long term, open label study of migalastat HCl (AT1001) in subjects with Fabry     disease who completed treatment in a previous monotherapy trial with migalastat hydrochloride     (HCl).   "
139547|NCT01458106|"     The primary objective of the study is to evaluate the safety of Recombinant Coagulation     Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with     hemophilia A. Secondary objectives of this study in this study population are as follows: to     evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to     evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc     consumption for prevention and treatment of bleeding episodes.   "
139548|NCT01458093|"     In colorectal cancer screening era a huge burden of medical resources has been applied to     surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a     mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of     surveillance are lacking.      The aim of present study was to evaluate the percentage of subjects in which timing of     surveillance colonoscopy in practice agrees with that recommended by guidelines and to     identify factors associated to the appropriateness of surveillance.   "
139549|NCT01458080|"     Hepatitis C Virus (HCV) is a leading cause of chronic liver disease (CLD) worldwide. Current     mainstay of treatment is combination therapy with pegylated interferon and ribavarin.     Thrombocytopenia as a treatment related adverse event or a complication of chronic liver     disease often necessitates dose reduction and discontinuation in these patients.     Revolade®/Promacta® (eltrombopag) is an oral second generation thrombopoietic growth factor     in development for the treatment thrombocytopenia associated with various conditions,     including secondary thrombocytopenia related to CLD and hepatitis C. In 2009 a phase III     trial for CLD patients undergoing an elective invasive procedure (ELEVATE) was terminated     early due to an imbalance of thromboembolic events (TEE) between the placebo and the     eltrombopag arm. Currently, two global interventional Phase III trials (ENABLE 1 and ENABLE     2) are being conducted in approximately 1500 patients to evaluate the efficacy of eltrombopag     in enabling HCV patients to achieve sustained viral response. Due to the similarities between     the patient groups in ELEVATE and ENABLE, there is a concern that invasive procedures may     influence the risk of TEE in the ENABLE population. This observational, non-interventional,     retrospective, multicentre, nested case-control study will collect data from chart     abstraction and medical record review to augment data from the ENABLE case report forms     particularly with regards to invasive procedures. The study population includes cases and     controls drawn from the ~1500 participants of the ENABLE trials. All eligible cases of TEE     will be included in the study as cases. All other patients who participated in the ENABLE     trials and did not experience a TEE, will be eligible to be selected as controls. Case report     forms will be developed to enable standardized data capture. The Sponsor has contracted with     the Clinical Research Organization, Outcome Sciences Inc to manage the study. ENABLE     investigators will work with Outcome staff to obtain relevant information from the treating     physician (e.g. surgeon) and the facility where the invasive procedure was performed     (pre-operative tests, peri-operative course, diagnostic testing for TEE). Single point     abstraction will be performed to obtain data from the medical record and from any additional     data resources obtained by the investigator (e.g., operative note, anesthesia record).     Analyses will be conducted using logistic regression models to estimate the risks. The     primary objective of the study is to evaluate if there is an increased risk for TEE among     patients who had an invasive procedure while exposed to eltrombopag (during the ENABLE     trials).   "
139550|NCT01458067|"     The study consists of a pre-screening period to determine if the subject's tumor has PTEN     deficiencies. Subjects then continue into the screening phase for Part 1, 2, or 3, as     appropriate. In Part 1, subjects will then receive a single dose of 25 mg. After analysis of     24 hour pharmacokinetic (PK) samples, subjects may receive continuous dosing or receive a     single modified dose. In Part 2, subjects will be enrolled and dose escalation will occur in     a 3+3 design. Subjects will receive a single dose on Day 1, and then begin continuous daily     dosing after collection of a 72-hour PK sample. Additional subjects may be enrolled at lower     dose levels for assessment of pharmacodynamic response. In Part 3, up to two tumor-specific     expansion cohorts will be enrolled and receive the MTD or BED as defined in Part 2. A minimum     of 12 and a maximum of 20 evaluable subjects will be enrolled in each cohort. Interim     monitoring for futility will be incorporated after response data from 12 subjects are     available. In addition, up to 20 evaluable subjects will be enrolled into Part 3     -Signal-finding Expansion Cohort at the MTD or BED as defined in Part 2. All subjects in all     parts/cohorts will receive daily dosing until withdrawal or unacceptable toxicity. All     subjects in all parts/cohorts will receive daily dosing until withdrawal or unacceptable     toxicity.   "
139551|NCT01458054|"     This study is a Phase I open label drug interaction study to evaluate the effect of     omeprazole and ritonavir on GSK2336805.   "
139552|NCT01458041|"     Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb     ischemia by recording clinical parameters.   "
139553|NCT01458028|"     Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy     subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in     blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will     be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days.     The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the     5 days of the study.   "
139554|NCT01458015|"     The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e.     reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain     signs and symptoms in comparison to oxycodone.   "
139555|NCT01458002|"     This study targets two major risk factors for cancer; is designed to treat the behaviors on a     population basis, using proactive recruitment strategies; intervenes on multiple behaviors     simultaneously, thereby producing greater impacts for cancer prevention; utilizes one of the     most promising approaches to low cost population based interventions for health-related     behavior change, namely the internet; and develops and tests a promising new approach to     increasing the utilization and effectiveness of internet-based interventions, relational     agents. The primary aims are: (1) To develop and assess the effectiveness of a tailored     internet intervention on a national sample; (2) To develop and assess the effectiveness of     the internet intervention enhanced by a relational agent; and (3) To determine if the     intervention with the relational agent can outperform the regular tailored internet     intervention.   "
139556|NCT01457989|"     The objective of this meta-analysis is to provide data on long-term safety and efficacy     following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion     for retigabine using pooled data from ongoing open-label extension (OLE) Studies     VRX-RET-E22-303 and VRX-RET-E22-304.   "
139557|NCT01457976|"     The study concerns a survey of attitudes of the public on issues around personal     responsibility for health and the use of financial incentives to promote health in the U.S.     and Germany. All data are gathered anonymously through online platforms. Two separate     professional panel providers are used for access to members of the public. All participants     are people who have voluntarily joined a survey panel in the past through an informed consent     process and currently serve as panel members.   "
139558|NCT01457963|"     The primary objective of this study was to estimate the prevalence of PE among consecutive     ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent     injection, regardless of whether PE was suspected clinically. The secondary objectives were     to assess the association between PE and DVT, to identify risk factors for VTE, and to     determine the outcome of VTE.   "
139559|NCT01457950|"     The purpose of this study is to determine if denosumab is effective in increasing bone     mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.   "
139560|NCT01457937|"     The cohort of post-menopausal women represents a group of very-difficult-to-treat patients in     whom a more powerful approach is required in order to improve the disappointing response     rate. Thus the addition, in patients with previous failure to PEG/RBV treatment or in naïve     patients, of a powerful drug like Boceprevir could greatly improve SVR rate as suggested by     the results of SPRINT_2 trial in whom Boceprevir addition determined a 30% improvement in SVR     rate in difficult gt 1 patients of African descent versus standard PEG IFN/Ribavirin therapy     or by those of RESPOND-2 that showed the same percent improvement of RGT-retreatment with     Boc/P/R of previous failure of standard therapy.      Goal of the study is to verify whether the addition of a 24-week treatment with boceprevir to     standard antiviral therapy with Peg IFN and ribavirin will increase the rate of SVR in     patients difficult to treat, such as HCV-positive women in post-menopausal women with     genotype 1, not only those who have never been treated, but also in those who have not     responded to previous treatment with peginterferon and ribavirin (Riba).   "
139561|NCT01457924|"     Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that     specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which     expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid     immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that     targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse     rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both     well tolerated and efficacious in several indications, including a small, placebo-controlled     trial in RRMS using an intravenous (IV) formulation.      This double-blind, placebo-controlled, parallel-group study will investigate the safety and     efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS.     The primary objective of the study is to investigate the efficacy as assessed by magnetic     resonance imaging. Other objectives will include evaluation of tolerability/safety,     dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as     other clinical endpoints.   "
139562|NCT01457911|"     Primary Objective:        -  To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL          M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as          reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes          mellitus (T2DM) inadequately controlled with metformin.      Secondary Objectives:        -  To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed dose          combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison          with glimepiride (AMARYL) alone at week 20.        -  To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of          glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL)          alone at week 20.        -  To assess the safety and tolerability of fixed dose combination of glimepiride and          metformin (AMARYL M 1/250mg).   "
139563|NCT01457898|"     Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac     patients but more studies are necessary to clarify its respiratory and hemodynamic effects.     Therefore, the investigators objective was to study its effects in the oxygenation index     (PaO2/FiO2) and in hemodynamic variables in this group of patients.   "
139575|NCT01457742|"     The purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio     Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients     with mild to moderate Osteoarthritis and to determine the duration of clinical benefit     following discontinuation of treatment.   "
139578|NCT01457703|"     The purpose of this study is to determine why obese women have lower hormone levels and less     fertility than women of normal body weight. The proposal will examine the reproductive system     at the level of the brain and the ovary to define the changes that happen leading to lowered     hormone production. Women will be studied throughout a menstrual cycle and given medications     that will test how well their pituitary gland can make hormones that stimulate the ovary     (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a     medication to abolish estrogen production in the body and their response to this medication     will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will     be examined.      --Hypotheses:        1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing          hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese          compared to normal weight women)        2. Obese women have abnormally increased sensitivity to estradiol negative feedback which          will be reversed by an aromatase inhibitor. (comparative study of obese compared to          normal weight women)   "
139564|NCT01457885|"     Although transplant results for AML in complete remission (CR) at the time of transplant have     improved, transplant results for non-remission AML have been quite poor. Most multi-center     studies have focused on standard risk AML patients and not many studies have been done in     this population of patients with non-remission AML. There are a large number of older     patients with non-remission AML because the complete remission rate with induction     chemotherapy decreases with age. Such older patients do not tolerate conventional full     intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for     non-remission AML is a great unmet need for current transplant practice.      From the investigators earlier study, it is suggested that replacing Fludarabine of standard     FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in     the transplant conditioning regimen may potentiate the anti-tumor activity of the     conditioning regimen without adding significant toxicity, a goal of new conditioning regimen     development.      The investigators expect to enroll a total of 75 patients from about fifteen sites. The     investigators main objective is to confirm both the safety and efficacy as measured by     one-year overall survival, of the CloBu4 combination as full intensity conditioning for     non-remission acute myelogenous leukemia.   "
139565|NCT01457872|"     This study aims to study and implement active referral of heroin users from a syringe     exchange programme to evidence-based treatment for heroin addiction. Patients are randomized     to either a strength-based case management intervention or a control group, while both groups     receive referral to medical investigation for inclusion in substitution treatment for heroin     addiction. The hypothesis is that syringe exchange can be used for referral to effective     treatment, and that a strength-based intervention can increase the number of patients who are     successfully referred and enter treatment.   "
139566|NCT01457859|"     The purpose of this study is to assess whether triclosan-coated sutures reduces wound     infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG     patients.   "
139567|NCT01457846|"     The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547     compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose     tumours are found to have FGFR2 polysomy or gene amplification.   "
139568|NCT01457833|"     Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in     the same way following either implantation of endobronchial valves or intrabronchial valves.   "
139569|NCT01457820|"     Allopurinol is a drug commonly used to treat gout. However recent studies have shown it has     the potential to help improve oxygen supply to heart muscle. In this study the Investigators     aim to find out if allopurinol slows down the onset of angina symptoms, as seen by a doctor     on a tracing of the heart (ECG- electrocardiogram), for patients who have been diagnosed with     heart disease, when exercising on a treadmill. The Investigators are also are trying to     figure out the best dose of allopurinol to use and to see how quickly it begins working. To     do this the investigators will recruit patients with angina, exercise them on a treadmill     after giving different doses of allopurinol and see if there is an improvement in their time     to bring on angina symptoms and signs. Patients recruited to this trial will receive three     different treatment regimes over a six week period. Each treatment regime will last for one     week with a one week rest period between each regime. This will involve up to eleven visits     to Ninewells Medical School, Dundee for testing.   "
139570|NCT01457807|"     To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new,     different extended release formulations of tablets of AZD3241 (300 mg), in relation to the     100 mg extended release tablet used in a previous study and potential food interaction. The     safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In     addition to these a number of exploratory objectives will be investigated with blood     sampling.   "
139571|NCT01457794|"     The aim of this randomized crossover study, is to investigate the effect of school meals     based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep     quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes     and osteoporosis in 8-11 year old Danish school children.      The participating 3rd and 4th grades on 9 selected primary schools will be randomized to     either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual     school lunch for 3 mo and then crossover for additional 3 mo. All participants will be     examined three times; at baseline, after 3 mo and after 6 mo.   "
139572|NCT01457781|"     This is a Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine     Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as     Add-on Therapy in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH).   "
139573|NCT01457768|"     This Registry is designed to obtain long term data on participants who have failed to achieve     sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent     (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.   "
139574|NCT01457755|"     This Registry is designed to provide long term clinical and virologic follow up in     participants who have achieved sustained virologic response (SVR) while participating in a     previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is     observational and no treatment is provided for HCV.   "
139576|NCT01457729|"     Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard     bike ergometer which is additionally equipped with a system to gather training data and the     ability to send daily training time to an internet server to which the physician has access.     Training time of two groups is compared. Group one is not motivated while group two benefits     from telephone feedback when training time declines. It is presumed that training time     increases with better information and response to training behaviour.   "
139577|NCT01457716|"     The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and     Formoterol after administration of 3 different product variants of Budesonide/Formoterol     Easyhalers and Symbicort turbuhaler.   "
139582|NCT01457651|"     The risk of respiratory failure after cardiac surgery is high, and it may result in many     complications. The maneuver of alveolar recruitment may improve the oxygen transport in the     human organism. The investigators compare three different types of alveolar recruitment in     patient after cardiac surgery, to reveal which one is better.   "
139583|NCT01457638|"     The purpose of this study is to determine whether inferior turbinate surgery during     rhinoseptoplasty is effective in improving quality of life and acoustic rhinometry outcomes.   "
139584|NCT01457625|"     Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation     of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis     patients; besides, it is associated with insulin resistance in general population. Hepatic     fat accumulation enhanced fetuin A secretion in animal model.      Objects This study is designed to investigate the association of fetuin A level, insulin     resistance and hepatic fat content in dialysis patients. Besides, we planed to observe the     survival of dialysis patient with different hepatic fat content.      Methods. This is a prospective observational study. Three hundred and fifty ESRD patients     undergoing maintenance HD or PD will be recruited for this prospective investigation. All the     participants will receive baseline abdominal ultrasound for estimation of hepatic fat     content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according     to the Hepburn classification. Besides, all participants also check baseline fetuin A,     HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C),     nutritional parameter and other biochemical parameters. All participants will be followed for     4 years for survival analysis. The outcomes are all-cause mortality and composite CV     mortality.      Expected results Dialysis patients with higher hepatic fat may have higher fetuin A levels     which may lead to long-term survival benefits.   "
139585|NCT01457612|"     The primary study objective is to investigate the potential chronic beneficial effect of     polyphenolics derived from strawberry on impaired insulin signaling in insulin resistant     individuals through their ability to modulate oxidative- and inflammatory-markers that lead     to devastating disease, including, but not limited to, diabetes and cardiovascular disease.   "
139586|NCT01457599|"     The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic     metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators     want to investigate if the wire marking is a possibility to mark respectively to identify     these lesions. Further the investigators want to evaluate how many patients with complete     radiologic have complete histologic response in their specimen respectively in how many     specimens in the definitive histology tumor cells are visible.   "
139587|NCT01457586|"     Observational Study of Hemoderivative Transfusion Imputable Complications in Initial     Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical     ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs     up to the beginning of the second postoperative day.      Blood transfusion might be only a marker of the patient severity.   "
139588|NCT01457573|"     A single center, pilot trial with combination therapy of tamsulosin and solifenacin in 20 men     with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline,     1, 2, and 3 months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported     outcomes.   "
139589|NCT01457560|"     This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK)     Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix     hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of     DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.   "
139590|NCT01457547|"     The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and     HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.   "
139591|NCT01457534|"     Background. Acute renal failure after liver transplantation (LT) requiring continuous renal     replacement therapy (CRRT) adversely affects patient survival. However, there are few reports     to assess the predictors for postoperative CRRT in liver transplant patients. The     investigators undertook this study to identify perioperative factors that would predict     patients at risk of CRRT.      Patients and Methods. The investigators retrospectively reviewed the data of 148 liver     transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei     University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18     patients from living and 26 from deceased donors) and those without CRRT was 104. Univariate     and stepwise logistic multivariate analyses were performed.   "
139592|NCT01457521|"     This trial will compare two oral analgesic regimens in women undergoing first trimester     medical abortion with mifepristone and misoprostol. The primary study outcome is pain.   "
139593|NCT01457508|"     This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals'     (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate     administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at     3, 5 and 11 (or 12) months of age.   "
139594|NCT01457495|"     This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly     SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the     separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines     administered at 3 and 5 months of age.   "
139637|NCT01455935|"     The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion     studies as an indicator to treat stroke patients with unknown time of onset.   "
139638|NCT01455922|"     Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to     metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.   "
139595|NCT01457482|"     Earlier research has shown that pregnant women with a pronounced fear of childbirth have a     significantly increased risk for birth complications and subsequent psychological trauma. In     Sweden and also internationally, women in fear of childbirth are treated in many differing     ways. Evidence for best care for these women is lacking. The Art Therapy method is a     creative, psycho-therapeutic form of treatment which has been used for several decades within     psychiatry. It has recently been seen that the Art Therapy method has positive effects during     treatment for crisis reactions.      Recruitment has recently been initiated for a randomized controlled study of Art Therapy for     the treatment of fear of childbirth.      The hypothesis for the study is as follows:      H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in     fear of childbirth when compared to treatment by therapeutic conversations only.      The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery     Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in     Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.   "
139599|NCT01457430|"     The investigators propose a study to evaluate the safety, local tolerability, convenience,     and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary     angioedema. The investigators believe that self administration with Icatibant for treatment     of an acute attack of angioedema will not change the time to complete or near complete     resolution of symptoms compared to treatment with Icatibant in a medical facility.   "
139600|NCT01457417|"     The purpose of this trial is to characterize the safety and toxicity of DKN-01 by determining     a maximum-tolerated dose and associated dose limiting toxicity. To evaluate the     pharmacodynamic response in patients with cancer. To characterize the pharmacokinetic     parameters of DKN-01 in cancer patients who are intolerant to standard/approved therapies.   "
139601|NCT01457404|"     The purpose of this study is to assess the safety and practicality, feasibility and efficacy     of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans     population, as delivered by routine clinicians at the Veterans Affairs.   "
139602|NCT01457391|"     The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as     delivered by routine addiction counselors in community treatment programs, and to compare CBT     for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the     primary outcomes.   "
139603|NCT01457378|"     The aim of this study performed in Irritable Bowel Syndrome (IBS) subjects and healthy     patients is to demonstrate the ability of composite score of frequency of gastrointestinal     symptoms to discriminate healthy subjects and IBS patients. The properties of this     questionnaire of composite score of gastrointestinal symptoms frequency will be compared to     other validated questionnaires (severity of IBS symptoms and HRQoL).   "
139604|NCT01457365|"     Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a     subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of     vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in     China. This study will research the serum 25OHD level to get the prevalence of vitamin D     deficiency and insufficiency of urban and rural residents in Sichuan Province, China.   "
139605|NCT01457352|"     The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in     the treatment of spasticity.   "
139606|NCT01457339|"     This is a multiple ascending dose study; the purpose of this study is to examine the safety,     tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic     Patients who are currently maintained on a stable dose of an antipsychotic medication.   "
139607|NCT01457326|"     The purpose of this prospective study is evaluate the effect of a standardized early weight     bearing physical therapy protocol that utilizes immersion therapy on the clinical outcomes of     lower extremity periarticular fractures. The investigators null hypothesis is that the early     weight bearing protocol will have the same effect as a traditional 10-week non-weight bearing     protocol on clinical outcomes.   "
139608|NCT01457313|"     postoperative pain and analgesic consumption between the first and the second surgery would     be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).   "
139609|NCT01457300|"     The Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in a District     Inpatient Rehabilitation Centre is better than in a Standard Primary Health Care     Rehabilitation Programme in Short Term Beds in Nursing Homes.   "
139610|NCT01457287|"     This is a prospective, longitudinal, controlled study of cognitive function and fatigue in     patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In     addition to following each patient over time (i.e. acting as their own control), a separate     control group will consist of patients with early stage CRC (Stage A or B) who have had     surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients     with stage C CRC who have declined chemotherapy.      Also included is a smaller sub-study of patients with limited metastatic CRC who are treated     with more toxic chemotherapy      To compare changes in cognitive function, as compared to baseline assessment, of patients     with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive     function are the High Sensitivity Cognitive Screen (HSCS) & Coghealth™.   "
139611|NCT01457274|"     In this trial, patients undergoing elective colonoscopy under sedation will be randomised to     BIS-guided sedation targeting either light (bispectral index [BIS] 70-80) or deep     (BIS<60) sedation. Sedation will be achieved with a standardised regimen of target-controlled     infusion of propofol and fentanyl bolus. The primary end point will be the incidence of     procedure recall in each group - this will be assessed at the conclusion of the procedure.     The procedural conditions, cardio-respiratory complications and recovery including cognitive     function will be assessed during and immediately after the procedure. The incidence of     dreaming and patient satisfaction with anaesthesia care will be recorded immediately after     the procedure. The study will be complete when the patient leaves the hospital on the day of     the procedure.   "
139639|NCT01455909|"     Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin     monotherapy in patients with type 2 diabetes.   "
139640|NCT01456923|"     Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy     combined with surgery in colorectal cancer (CRC) avoiding surgery complications.   "
139612|NCT01457261|"     Idiopathic pulmonary fibrosis is a relentlessly progressive disease that is responsible for     the deaths of over 5000 people in the UK each year. At present, despite a dramatic increase     in clinical trials in the last decade, there are no licensed treatments for IPF. The     pathogenesis of the condition remains incompletely understood, nonetheless there is good     evidence to suggests that the condition arises as the consequence of an aberrant wound     healing response in genetically susceptible individuals. Basic science research into IPF has     identified a wide range of potential treatment targets. However, in many cases developing     compounds to act against these targets, because of their role in normal wound healing, is     limited by the possibility of major systemic side effects.      The lung is highly amenable to topical therapy in the form of inhaled drug preparations and     this route is utilised in the treatment of the majority of respiratory disease. The inhaled     route offers a number of important potential advantages for administration of therapy to     patients with IPF. Firstly, by limiting systemic exposure to drugs, the inhaled route offers     the potential for achieving higher lung doses of drugs that might otherwise cause systemic     toxicity. Secondly, inhaled treatment may more effectively reach the areas of abnormality in     IPF, namely the hyperplastic epithelium and the underlying fibroblastic foci. Thirdly, the     inhaled route offers an alternative to parenteral administration of compounds that are poorly     absorbed through the gastro-intestinal tract e.g. monoclonal antibodies. It should be noted     however, that the fibrosis in IPF develops peripherally involving the alveolar interstitium     and the terminal bronchioles. Furthermore, the disease causes architectural destruction and     distortion of the lung that is liable to alter the normal laminar flow of air (and inhaled     particles) through the bronchial tree. It is therefore, by no means certain that it is     possible to deliver inhaled therapies directly to regions of fibrosis in IPF.      The feasibility of delivering inhaled drugs in IPF has not been previously studied. This     research by assessing the effect of particle size on inhaled particle deposition and by     relating to this the pharmacokinetic profile of salbutamol aims to validate the potential of     the inhaled route in IPF. This study is an important precursor to the development of specific     topical therapies for patients with IPF.   "
139613|NCT01457248|"     The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental     lung model, endotracheal tube with taper-shaped cuff has been shown to decrease     microaspiration. This effect has never been demonstrated in patients. The investigators     hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of     postoperative pneumonia in patients after aortic surgery.   "
139614|NCT01457235|"     Cognitive remediation (CR) is a new psychological treatment, which aims to improve cognitive     function and coping skills. Several studies have recently demonstrated that CR improves     cognitive and occupational function in patients with schizophrenia and with depression (e.g.     Wykes et al 2007, Elgamal et al 2007). However, it is unclear whether CR improves cognitive     and socio-occupational function in individuals with bipolar disorder (BD) and, if so, what     impact this might have on these people's abilities in terms of work, coping strategies,     quality of life, and everyday safety.      The aim of the present PhD study is to investigate if CR has beneficial effects on cognitive     and socio-occupational function in patients with previous mania and depression who experience     persistent cognitive difficulties. Such effects would suggest implementation of CR in future     treatment of bipolar disorder in order to facilitate the patients' ability to cope with the     responsibilities related to work and everyday life. The hypotheses of the present study are     that CR (in comparison to standard treatment) will 1) improve verbal learning and recall; and     2) improve sustained attention, executive function and psychosocial function.   "
139615|NCT01457222|"     The purpose of this study is to determine whether mindfulness is useful as primary prevention     for psychological health in highschool students, primarily related to stress, and whether     mindfulness can improve cognitive function.   "
139616|NCT01457209|"     The central hypothesis is that acupuncture break the vicious circle of androgen excess and     reverse insulin resistance and improve health related quality of life and affective symptoms     in overweight and obese women with and without Polycystic Ovary Syndrome.   "
139617|NCT01457196|"     The primary objective of this specimen correlative study is two-fold: to provide a mechanism     for the association of known molecular alterations with clinical outcomes, and to provide     rapid genetic profiling of alterations with known clinical utility using tumor and germline     specimens to support treatment decisions.   "
139618|NCT01457183|"     This study evaluates how subjects with intact skin tolerate a water jet (psi 10-12) and how     well the water stream is contained by a new containment device.   "
139619|NCT01457170|"     The purpose of this study is to determine the effects of Apelin on the lung circulation. The     investigators hypothesise that Apelin will relax the lung blood vessels and improve the     pumping ability of the heart.   "
139620|NCT01457144|"     Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and     Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or     refuse receive conditioning regimen followed by autograft.   "
139621|NCT01457131|"     Background:      - A new cancer treatment involves collecting white blood cells from an individual, modifying     them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning     them to the body. The cells may then be able to seek out the cancer cells and destroy them.     Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the     cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them to     treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1     protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that     stimulates the immune system. This type of therapy is called gene transfer.      Objectives:      - To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against     metastatic cancer.      Eligibility:      - Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and     has not responded to standard treatments.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood tests and imaging studies.        -  Participants will have leukapheresis about a month before the treatment to collect white          blood cells.        -  They will have chemotherapy 5 days before the treatment to suppress the immune system,          and prepare the body for the anti-ESO-1/IL-12 cells.        -  The anti-ESO-1/IL-12 cells will be given as an infusion.        -  Participants will be monitored in the hospital during their recovery from the treatment.        -  Participants will have regular followup exams every 1 to 6 months. The exams will          include blood tests, imaging studies, and other studies.      Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of     the study....   "
139622|NCT01457118|"     The study objective of this open label, multicenter study is to provide access to NKTR-102     treatment to subjects previously enrolled in a NKTR-102 study who are without signs of     disease progression since receiving NKTR-102.      In addition the study will evaluate the safety of continued exposure to NKTR-102, observe     disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy     of NKTR-102 in subjects with advanced or metastatic solid tumors.   "
139623|NCT01457105|"     self-expandable metal stents for palliation of malignant biliary strictures   "
139624|NCT01457092|"     The purpose of the study was to analyze the resolution rate of benign biliary strictures due     to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully     covered self-expandable metal stents.   "
139666|NCT01456585|"     This is a pilot study to evaluate the role of the addition of CP870, 893 to the neoadjuvant     and adjuvant setting for patients with resectable pancreatic cancer. Patients will receive     standard surgery followed by chemoradiation for their disease, but one dose of gem/cp 870,893     will be pre-op and 3 doses post-op.   "
139625|NCT01457079|"     Radiation therapy has been, and is being used in treatment of patients with keloid. Radiation     is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid.      Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause     secondary cancers. The investigators also do not have a good understanding as to how     effective radiation therapy is in preventing recurrence of keloid.      Purposes of this study are to determine the long term safety as well as efficacy of radiation     therapy when used for treatment of keloid.   "
139626|NCT01457066|"     The goal of this proposal is to culturally adapt and tailor an existing, theory-based     intervention, using state-of-the-art methods designed to maximize cultural sensitivity,     feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized     controlled trial (n=60 intervention; n=60 control).   "
139627|NCT01457053|"     The purpose of this research study is to compare the effects (good and bad) of     ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy     (furosemide, torsemide, bumetanide) on your heart function and blood flow.   "
139643|NCT01456884|"     The purpose of this within-subjects randomized controlled trial is to determine whether two     music therapy interventions are efficacious in reducing pain symptoms, in order to improve     the quality of care for children in pediatric hospice. The investigators hypothesize that     both music therapy interventions, live guitar and vocal intervention and vibroacoustic     intervention, will reduce behavioural pain scores and that behavioural pain scores will     correlate with physiological outcome measures.   "
139644|NCT01456871|"     The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP     joint ligamento-muscular reflexes and their role is.   "
139628|NCT01457040|"     Evolving paradigms in the treatment of adult ALL include the application of intense pediatric     regimens to the treatment of adolescents and young adults (AYA) and the optimization of     allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the cure of patients. The     Cancer and Leukemia Group B (CALGB) and the Children's Cancer Group (CCG) first asked whether     AYA between the ages of 16 and 20 fared differently whether they were treated on pediatric     protocols. The results of this study demonstrated that although the complete remission rates     were identical for the AYAs treated on the CALGB and CCG trials, the AYAs had a 63%     event-free survival (EFS) and 67% OS at 7 years on the CCG trials compared with 34% and 46%,     respectively, on the CALGB trials.      High relapse and transplantation-related-mortality still remains great challenge for HSCT of     adult ALL, which both range between 25% and 30%. Recently, risk-adapted indication and     optimization of conditioning regimen are highlighted, which aiming to reduce TRM and relapse     rate, respectively.City of Hope National Medical Center studied the substitution of etoposide     (VP-16) for CY in the treatment of ALL patients receiving HCT. The result suggested that     etoposide and TBI are associated with a decreased relapse rate following transplantation for     ALL, compared with those receiving CY and TBI. Japanese and Germany reports pronounced the     advantage of VP-16 in intensified regimen for adult ALL. On the same time, the investigators     previous researches have confirmed the effect and safety of FA-intensified conditioning     regimen on relapse and refractary leukemia.      Based on mentioned above, the investigators speculate that VP-16-intensified conditioning     regimen could improve the outcome for adult ALL. The potential mechanism will be attributed     to reduce MRD and promote GVL effect via providing enough time-window for     immuno-reconstitution by high-dose preparative regimen.   "
139629|NCT01457027|"     A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V     according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine     strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine     strains and to assess the cross-protection against 4 selected circulating heterogeneous     A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.   "
139630|NCT01457014|"     The purpose of this study is to evaluate positive pressure in patients with chronic pain     taking opioid medications who have sleep disordered breathing.   "
139631|NCT01457001|"     Multicentric randomized Italian clinical trial, open label, not for profit. To evaluate the     efficacy of 25-OH-D vitamin in terms of myocardial infarction, stroke, sudden death, death     for other causes in chronic haemodialysis patients. Two arms of treatment: 25-OH-D vitamin     per os versus no treatment.   "
139632|NCT01456975|"     The investigators expect that the using of prothesis with sinuses has more benefits for long     term competence and condition of aortic valve than the using of straight prothesis.   "
139633|NCT01456962|"     Increases in cluster of differentiation 4 (CD4)+ T cells in the blood is well documented in     human immunodeficiency virus (HIV)-infected individuals after starting antiretroviral therapy     (ART), but increases CD4+ T cells in the cervix is variable and not fully understood.     Although the amount of HIV in the vagina declines in parallel with those in the plasma when     antiretroviral therapy for HIV is started, HIV is still detected frequently in cervical     samples from women with undetectable plasma viral loads, suggesting that low level viral     replication in the female vaginal tract could lead to both inflammation and incomplete     increases in CD4+ T cells. Two classes of HIV medications, nonnucleoside analogue reverse     transcriptase inhibitors and protease inhibitors are substantially lower in the female     genital tract compared to plasma, whereas concentrations of another class, nucleos(t)ide     analogue reverse transcriptase inhibitors are similar or higher to those found in plasma.     Thus, many widely used first-line three drug HIV therapies only achieve high concentrations     of only two medications in the female genital tract. Importantly, with the recent development     of raltegravir (RAL), which achieves concentrations in the female genital tract higher than     those in plasma, ART regimens that deliver high concentrations of 3 antiretroviral drugs to     the female genital tract are now available. The investigators hypothesize that cervical CD4+     T cell reconstitution is better and inflammatory markers are lower in HIV-infected women on a     HIV-therapy including tenofovir (TDF) and emtricitabine (FTC) with RAL versus ritonavir     (RIT)-boosted atazanavir (ATZ), and that this is due to therapeutic concentrations of 3     versus 2 antiretroviral drugs in the female genital tract.   "
139634|NCT01456949|"     The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm,     controlled,unblinded clinical study designed to provide long-term safety and effectiveness of     the Arctic Front® Cardiac CryoAblation System.   "
139635|NCT01456936|"     This study is being conducted to assess varenicline and bupropion as aids to smoking     cessation treatment in subjects with and without an established diagnosis of major     psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified     adverse events (AEs) in both of these populations).   "
139636|NCT01455948|"     The economic, patient related outcome, and effectiveness of balloon sinuplasty in the     treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare     environment is not known at this time. This study will evaluate the impact of balloon     sinuplasty and traditional FESS treatment on CRS patients.   "
139641|NCT01456910|"     Resistance exercise (RE) has been proposed as a possible strategy for prevention and     rehabilitation of diseases. The increase in both muscle strength and the ability to perform     tasks of day-to-day work environment and are well-characterized benefits of this type of     training. The literature has been investigating the effectiveness of the RE for humans, yet     few studies have been conducted with intellectual disabilities (ID). It is known that a     sedentary lifestyle contributes to the development of cardiovascular disease, type 2     diabetes, hypertension, arthritis, and stress, depression, difficulty in socializing, stigma     and discrimination. In particular, the ID is less active and is more likely to develop     secondary diseases.   "
139642|NCT01456897|"     To investigate the safety and efficacy of long-term administration of OPC-34712 in patients     with schizophrenia.   "
139655|NCT01456728|"     The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and     omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.   "
139645|NCT01456858|"     A Phase III malaria prevention trial was conducted in two camps of Liberian refugees in     Sierra Leone using Insecticide Treated Polyethylene Sheeting (ITPS) or untreated polyethylene     sheeting (UPS) randomly deployed to defined sectors of each camp. The ITPS was impregnated     with pyrethroid insecticide during manufacture. In Largo camp the ITPS or UPS was attached to     inner walls and ceilings of shelters, while in Tobanda the ITPS or UPS was used to line the     ceiling and roof only. Cohorts of children up to 3 years of age were cleared of malaria     parasites and monitored for up to 8 months post construction for possible malaria     re-infection. Installation teams and refugee groups were blinded as to whether the sheeting     was insecticide treated or not.   "
139646|NCT01456845|"     The purpose of the study is to estimate plasma drug levels ( free and total drug levels ) of     rifampicin and other antituberculosis drugs and compare these drug levels in patients who     develop drug induced hepatotoxicity versus those who do not .The study hypothesis is that the     ATT drug induced hepatotoxicity is related to free drug levels of rifampicin and other     antituberculosis drugs .   "
139647|NCT01456832|"     This study is designed to determine the causes of low sodium (salt) in the body fluids     outside the cells for patients who have received a kidney transplant at the Mayo Clinic of     Florida. The investigators will look at data collected on previous transplant patients at the     Mayo Clinic to determine if the low sodium levels could be related to factors occurring in     the course of surgery. The investigators hypothesize that the intravenous fluid used in the     surgery, which is about half the concentration of normal saline, could contribute to the low     sodium levels.   "
139648|NCT01456819|"     This is a randomized and single blinded study aimed to compare the efficacy between     intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell     implantation and intramuscular autologous bone marrow mononuclear cells implantation only in     patients with chronic critical limb ischemia. Patients will be randomized into two groups of     equal number; patients in one group will be implanted with mononuclear cells and mesenchymal     stem cells, and the other implanted with mononuclear cells only in the area of affected limb.   "
139649|NCT01456806|"     Objective: To evaluate the effect of system interventions (data recording procedures and     complete coverage of medications and supplies) with or without physician and/or patient     education, upon the psychological, clinical, metabolic and therapeutic indicators and the     costs of care of people with type 2 diabetes.      Design: Randomized 2x2 design; sample size was determined considering the change in     haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of     significance, and 80% power using a paired t-test. Sample size was increased by 25% to     account for non-independence and patient drop-out.      Setting: Primary care level in the city of Corrientes, Argentina with involvement of all     three Argentinean health subsectors (public health, social security and the private, prepaid     system).      Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with     type 2 diabetes. Patients of the participating physicians (nine in each group), were randomly     selected and assigned to one of four groups (117 patients each): control, provider education,     patient education, and provider/patient education.      Intervention: Structured group education programmes were delivered to provider and/or people     with type 2 diabetes by trained professionals; identical system interventions were applied to     all four groups.      Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c     levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5     questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.   "
139650|NCT01456793|"     The purpose of this study is to evaluate the effectiveness of the Teen Options to Prevent     Pregnancy (T.O.P.P.) program in increasing contraceptive use and reducing repeat pregnancies     among pregnant and parenting adolescents in central Ohio.   "
139651|NCT01456780|"     This is a Phase IV, single site, randomized, double masked, parallel control clinical trial     of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for     treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy     will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of     meibomian gland dysfunction and validated ocular symptom assessment questionnaire.   "
139652|NCT01456767|"     The design of this study conforms to a randomized double-blind placebo-controlled cross-over     design.      The objective of the study is to assess the effect of three probiotics (Lactobacillus     plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) on     intestinal epithelial permeability and the immune system, in at least 8 healthy subject.      The effect of the three different probiotics and a placebo will be assessed on every subject     in random sequence.      Prior to the start of a 7-days supplementation period (one of the three probiotic supplements     or placebo), blood samples will be obtained and small intestinal permeability will be     assessed by measuring the urinary extraction ratios of ingested water-soluble, non-degradable     test probes, with and without indomethacin challenge (to compromise the gut). After each     supplementation period the gut will be stressed again by the indomethacin protocol, followed     by measurement of small intestinal permeability, whereupon blood samples will be taken and     duodenal tissue samples will be obtained by standard gastroduodenoscopy. Each supplementation     period will start 1 month after finishing the pervious test episode, in randomized sequence.      The primary objective of this study is to assess the effects of Lactobacillus plantarum     WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on intestinal     epithelial permeability. Secondary objectives are to assess the effects on immune modulation,     gene expression of peripheral blood mononuclear cells, small intestine epithelial gene     regulation and tight junction proteins modulation, infiltration of immune cells in intestinal     mucosa and immune markers in blood plasma.      The investigators hypothesize that Lactobacillus plantarum WCFS1, Lactobacillus plantarum     CIP104448, and Lactobacillus plantarum CIP104450 will, each separately, significantly affect     the innate immune system and intestinal permeability in humans.   "
139653|NCT01456754|"     The purpose of this study is to determine the effect of feeding frequency on glucose and     insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.   "
139654|NCT01456741|"     Endobronchial lung cancer tend to manifest in three different patterns. It can present as a     bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from     peribronchial disease. Bronchoscopy with differents techniques as forceps biopsy, bronchial     brushing and bronchial washing is recognized as the gold standard to diagnose central airways     lung neoplasms. Some authors suggested that the addition of endobronchial needle aspiration     (EBNA) to these conventional diagnostic methods may increase the sensitivity of bronchoscopy     in submucosal and peribronchial disease but few prospective trials have been performed and     this procedure is still underutilized in many centers. Rapid on-site evaluation (ROSE) showed     to improve yield of transbronchial needle aspiration (TBNA) of mediastinal nodes and     pulmonary peripheral lesions, reducing the number of inadequate specimens and costs. However,     its utility during endobronchial needle aspiration has not been substantiated.      This prospective study has two primary objectives: to compare the sensitivity of ROSE-EBNA     with that of the conventional technique and to investigate the diagnostic yield of     endobronchial needle aspiration and its contribution to CDM in the evaluation of patients     with endobronchial lesions.   "
139656|NCT01456715|"     Two human papillomavirus vaccines are now commercially available.      No clinical data exist regarding:        -  The immunogenicity and safety of Gardasil and Twinrix when co-administered.        -  The immunogenicity and safety of Cervarix when administered to subjects previously          vaccinated with Gardasil.      The main objective of the first phase of this clinical trial was:      • To assess and compare the immunogenicity of Gardasil and Twinrix Junior when     co-administered or administered at one month interval according to a 0, 6 month schedule to     9-10 year-old girls.      The main objective of the seconde phase of this clinical trial is:      • To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when     given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.      Study Design & Duration:      Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study     with two treatment groups.      Duration of the study:      Participants will be followed for the duration of 10 years post-primary vaccination.      Number of Centres:      One Center.   "
139657|NCT01456702|"     It is difficulte to evaluate risk patients and to find the ideal intraoperative volume     management. It seems to be that ill patients benefit of a goal directed volume management.     The aim of this study is to implement the guidelines on perioperative cardiovascular     evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed     protocoll for volume management.   "
139658|NCT01456689|"     The primary purpose of this dose escalation study is to estimate the maximum tolerated dose     (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when     administered orally once daily to adult patients with Multiple Myeloma (MM).   "
139659|NCT01456676|"     The purpose of this study is to determine the feasibility of administering the combination of     nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid     leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose     level (RP2D) of LDE225 in combination with nilotinib.   "
139660|NCT01456663|"     This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe     hepatic impairment compared with healthy control subjects.   "
139661|NCT01456650|"     The objective of the study is to know if the R230C and C230C variants of the ATP-binding     cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect     compared to the wild type allele (R230R) in patients with type 2 diabetes.   "
139662|NCT01456637|"     The object of this study is to determine whether feedback added to a self-help protocol for     insomnia enhances the treatment effect. In this study all participants receive an online     self-help cognitive behavioral therapy (CBT) intervention consisting of information     (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with     insomnia will be invited via a popular scientific website to fill out online questionnaires.     Half of the participants will received by e-mail from a therapist, the other half of the     participants will do the intervention without feedback. Participants will be measured 4, 16,     and 40 weeks after intervention with the same questionnaires.   "
139663|NCT01456624|"     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and     Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.   "
139664|NCT01456611|"     The objective of this study is to evaluate the clinical equivalence and safety of the Test     formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to     the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in     patients with osteoarthritis of the knee.      The efficacy of both the Test and Reference formulations will also be compared to the Placebo     gel to determine Superiority.   "
139665|NCT01456598|"     -  It was confirmed that the laparoscopic surgery decreases the postoperative pain and          reduces the recovery periods in the various surgical fields such as cholecystectomy and          colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is          applicable to malignant tumor according to the development of surgical techniques and          medical instruments.        -  In case of early stage of gastric cancer, as the diverse clinical evidences, the          gastrectomy has been commonly applied, however, the opening surgery is still applied for          advanced gastric cancer due to lack of clinical evidence.        -  In Korea, approximately 38% of patients who undergo surgery for gastric cancer are          diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer          registration business in 2009). There are various clinical evidences to apply          laparoscopic surgery to the patients, however, most of them are retrospective or cohort          study results.        -  For the clinical application of surgical treatment regarding locally advanced gastric          cancer using laparoscopic surgical technique, it requires the confirmation of definite          execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of          surgery and oncological usefulness should be verified.        -  In order for this, it is only possible to confirm through the comparison of short-term          surgical results (complications, mortalities, operative time and duration of          hospitalization etc) and long-term results (survival rates and recurrence rates etc)          between laparoscopic surgery and opening surgery based on the multicenter large-sized          randomized prospective study with current standard treatment.   "
139668|NCT01456559|"     The purpose with the planned study is to study Pleth Variability Index (PVI) as a non     invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects.     Lower body negative pressure (LBNP), a well established technique is used to create defined     levels of hypovolemia.      Primary hypothesis: By applying a breathing resistance (positive end expiratory pressure     PEEP) to spontaneous breathing, the respiratory synchronous variation in the pulse oximeter     signal (PVI) is enhanced and enables PVI to detect and grade the level of mild hypovolemia.      Secondary hypothesis: 1) When tidal volume is increased, the respiratory synchronous     variation in the pulse oximeter signal (PVI) will also increase. 2) The earlobe is superior     to the finger in detecting PVI 3) Hemoglobin (Hb), detected non invasively by pulse oximetry,     is not affected by hypovolemia created by LBNP   "
139670|NCT01456533|"     Background: Hypo- and hypernatremia are common in hospitalized patients. The differential     diagnosis of dysnatremia is challenging.      Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism     in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger     precursor peptide along with copeptin, which is a more stable peptide directly mirroring the     production of ADH.      Objective: To evaluate the additional value of copeptin to improve a currently used algorithm     in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.      Design: Prospective observational study.   "
139671|NCT01456520|"     This study aims to determine whether the hydrocodone and acetaminophen exposures following     oral dosing of Vycavert are comparable to those following oral dosing of Norco.   "
139672|NCT01456507|"     The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets     on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an     extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered     naltrexone 4.8 mg.   "
139673|NCT01456494|"     The purpose of this study is to evaluate the feasibility of enrolling and randomizing     patients into one of two educational interventions to teach appropriate respiratory inhaler     technique and to collect preliminary estimates of the comparative effectiveness of two types     of education.      Teach-to-Goal (TTG) education employs instruction followed by patient teach-back, then     repeated cycles of learning and assessment until a skill, i.e. respiratory inhaler technique,     is mastered. By contrast, Brief Intervention (BI) education only consists of providing the     patient with verbal and written instruction on the skill, i.e., respiratory inhaler     technique.      The investigators hypothesize that hospital-based TTG compared to BI increases a patient's     ability to learn respiratory inhaler technique. The investigators will test this hypothesis     separately for the MDI and Diskus® devices.   "
139674|NCT01456481|"     About 20% of adults faint recurrently. These patients are often highly symptomatic, have     problems with employment and driving and have reduced quality of life. There are no therapies     that have withstood the test of adequately designed and conducted randomized clinical trials.     Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases     venous return to the heart and raises blood pressure. There is considerable lower level     evidence that it might prevent vasovagal syncope.      The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in     patients with moderate to severe vasovagal syncope.   "
139675|NCT01456468|"     The purpose of this research study is to determine whether the combination of UDCA and ATRA     taken for 3 months will improve laboratory tests of liver and bile duct inflammation in     patients with Primary Sclerosing Cholangitis (PSC). Our hypothesis is that a combination of     these medications will improve the liver inflammatory tests in these patients, specifically a     reduction in alkaline phosphatase (AP) by at least 30%.   "
139676|NCT01456455|"     Descriptive registry to investigate frequency of HER-2 positive gastric cancer involving CNS.      Exploration of additional prognostic factors for brain involvement from gastric cancer.   "
139677|NCT01456442|"     The aim of this monocentric, prospective, non randomised study with 25 healthy volunteers is     to assess anorectal function ( i.e rectal compliance and sensory thresholds) in health with a     short protocol barostat versus conventional procedures (i.e. standard barostat protocol and     high resolution anorectal manometry). Anorectal dysfunction is a key mechanism in the     development of fecal incontinence and symptoms of obstructive defecation.      In this study volunteers will be examined - after explanation, physical examination and     verification of in- and exclusion criteria - by anorectal barostat with short and standard     protocol as well as by proctoscopy and endoanal ultrasound.   "
139678|NCT01456429|"     This is a prospective non-randomized multicenter clinical trial performing endobronchial and     esophageal ultrasound for mediastinal lymph node staging of operable and resectable     cT1-T2-selectedT3 cN1 cM0 NSCLC.   "
139679|NCT01456416|"     The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis     population than in general population. These MS patients category response unfavorably to the     Interferon. The investigators suggest that autoimmune co morbidity can serve as a biological     marker predicting good response to GA.   "
139680|NCT01456403|"     Patients scheduled for carotid endarterectomy undergo preoperative imaging to assess     vulnerable plaque. The imaging modalities include (in various combinations at different study     sites) 3-dimensional ultrasound, PET/CT imaging with fluorodeoxyglucose, MRI (3T)with     gadolinium, and contrast ultrasound for assessment of neovascularity of plaques. At surgery     the carotid endarterectomy is carried out with en bloc removal of the specimen, which is     scanned and stained and assembled into 3D histology.   "
139681|NCT01456390|"     Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular     hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent     stents in combination with one iStent supra stent and a postoperative prostaglandin.   "
139682|NCT01456377|"     The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids     administered orally in narrow lumbar canal syndrome.   "
139728|NCT01455727|"     This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients.     To provide appropriate diabetes education administration, identify and resolve drug-related     problems, assess the appropriateness of their medications, establish the mechanism of     medication consultations. Each patient will be assessed by the MMSE(Mini-Mental State     Examination) and GDS(Geriatric Depression Scale). The effectiveness of pharmacist's     intervention will be assessed by lab data and some questionnaires.   "
139729|NCT01455714|"     Finding early predictors of myocardial in patients with hypertension        1. Scientific objective The study objective is to clarify the grounds of heart exertional          dyspnoea stenocardial pain in patients with well-controlled stage I or II hypertension          according to ESH (European Society of Hypertension), without changes in epicardial          coronary arteries in coronary angiography and normal resting echocardiography result,          and to assess of potential early markers of heart hypertrophy and failure in patients          with hypertension.           Characteristics of the final result The study is to allow for identification of patients          with hypertension, in whom an early introduction of pharmacological treatment of heart          failure should be considered. Evaluation in the detection of asymptomatic myocardial          dysfunction will include potential heart failure markers such as: cardiotrophin 1,          cystatin C, serum syndecan-4, collagen III N-terminal propetide [PIIINP], MMP-2, MMP-7,          MMP-8, MMP-9 and NT-proBNP, modern echocardiography methods and magnetic resonance          imaging in order to increase the effectiveness of prevention, diagnosis and treatment          optimalization.        2. Project significance Prognosis in heart failure is very serious. It is similar or worse          than in advanced cancer. These data indicate an extreme importance of the optimal early          causal treatment of hypertension and symptomatic treatment of heart failure early stage          in order to prevent the development advanced form of the disease, which has bad          prognosis. In clinical practice, patients with well-controlled hypertension often report          exercise limitation, exertional dyspnea and/or stenocardial pain which is not reflected          in a standard resting echocardiography (normal result), without coronary artery disease          data in electrocardiographic stress test and without change in epicardial coronary          vessels in coronary angiography. The study is designed to establish the panel of          diagnostic tests in patients with hypertension and exertional dyspnoea only, which will          allow for early detection of abnormalities (before symptoms occur) and the start of the          optimal treatment for these patients. Unfortunately, still too small percentage of          patients receives full pharmacotherapy, hence the authors of the latest guidelines of          procedure in heart failure and hypertension put great emphasis on this aspect. Optimal          management may prevent the progression of these patients in stage C heart failure, and          thus bring tangible benefits not only the patients themselves but also, by reducing the          number of costly hospitalizations, significantly reduce health care costs. The number of          hospitalizations for heart failure in Poland is estimated at 100 000 per year, and          hospitalization costs exceed 70% of the total costs associated with the treatment of          heart failure. The issue of exertional dyspnoea and overt heart failure in patients with          hypertension and normal results of resting echocardiography is a new problem, both in          Poland and in the world.      So far, there are no treatment recommendations for this group of patients. Material and study     plan 120 persons (age 40-60 years old) will be included in the study, patients with stage I     or II primary hypertension according to the European Society of Hypertension: Group A- 40     patients without symptoms of heart failure Group B- 40 patients with exertional dyspnoea     Group C - 40 patients with overt heart failure      In group B (patients with exertional dyspnea/stenocardia) we will include only patients who     have undergone contrast coronary angiography without any identified changes in the epicardial     coronary arteries, which will facilitate answering the presented purpose of research.     Patients in groups A and B with normal resting echocardiography and treated with a maximum of     2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base), according to the     following regimen:      ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance     with the standards for heart failure. Each patient will be informed about the objectives of     the study and give written consent to participate.      After signing informed consent patients will have performed the following tests:        -  Interview and documentation analysis,        -  Physical examination,        -  Electrocardiogram,        -  24-hour blood pressure monitoring (ABPM),        -  24-hour EKG recording,        -  Echocardiography at rest and during submaxinal exercise on a bicycle ergometer,        -  Flow-mediated dilatation (FMD),        -  Cardiac magnetic resonance imaging,        -  Standard labolatory parameters,        -  Levels of markers: cystatin C, cardiotrophin-1, metaloproteinases: MMP-2, MMP-7, MMP-8,          MMP-9, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP          Each patient will be informed about the objectives of the study and give written consent          to participate.   "
139683|NCT01456364|"     Clopidogrel low response is associated with a significantly higher risk for ischemic     complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more     potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic     events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in     terms of their antiplatelet efficacy exists. The aim of this study is to assess the     antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed     clopidogrel low responders undergoing percutaneous coronary intervention.   "
139684|NCT01456351|"     The study addresses the question if a therapy with bendamustine plus rituximab is comparable     (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to     event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.   "
139685|NCT01456338|"     The purpose of this phase of the study is to further assess the efficacy of cognitive     behavioral therapy (CBT) for posttraumatic stress disorder (PTSD), as delivered by routine     addiction counselors, and to compare CBT for PTSD with individual addiction counseling (IAC)     on our primary outcomes.   "
139686|NCT01456325|"     This randomized, multicenter, double-blind, placebo-controlled study will evaluate the     efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in     participants with incurable non-small cell lung cancer identified to be Met     diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb)     or placebo in combination with erlotinib. Anticipated time on study treatment is until     disease progression or unacceptable toxicity occurs.   "
139687|NCT01456312|"     Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion     rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week     follow up)      Secondary objective :        -  The changes of HBsAg titer             -  The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL ⅲ. The rate               of serum HBV DNA < 300 copies/mL                  -  The rate of ALT normalization ⅴ. The rate of HBsAg loss ⅵ. The rate of serum                    HBV DNA < 10,000 copies/mL   "
139688|NCT01456299|"     The purpose of this study was to determine the most suitable effect-site concentration of     remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.   "
139689|NCT01456286|"     The purpose of this study is to determine whether sapropterin (an oral analogue of     tetrahydrobiopterin) could have a role in the treatment of portal hypertension secondary to     liver cirrhosis. Sapropterin or placebo will be given for two weeks in patients with liver     cirrhosis and clinically significant portal hypertension. Systemic and hepatic hemodynamics     studies will be performed at baseline and after the intervention to assess the effect of     sapropterin.   "
139690|NCT01456273|"     This study aims to evaluate, in patients with functional dyspepsia, a model example of     medical care based upon the biopsychosocial model (called: the therapeutic encounter)     compared with standard medical care based upon the biomedical model (called: medical     consultation).   "
139691|NCT01456260|"     The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during     long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a     history of gastric or duodenal ulcer who require long-term therapy of NSAID.   "
139692|NCT01456247|"     The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during     long-term concomitant low-dose aspirin therapy in patients with a history of gastric or     duodenal ulcer who require long-term therapy of low-dose aspirin.   "
139693|NCT01456234|"     The main purpose of this study is to see if patients with the flu would receive oseltamivir     treatment more quickly if it were prescribed by a pharmacist as compared to a physician, and     to see if there is any difference in the effect of treatment on flu symptoms and overall     health. Another reason for doing the study is to see how accurately pharmacists can diagnose     the flu as compared to physicians. Viruses that are exposed to antiviral medications (like     oseltamivir) sometimes develop a resistance to the medication. This means that the medication     is no longer as effective in treating the symptoms caused by the virus. The development of     viral resistance to oseltamivir will also be followed in this study.   "
139694|NCT01456221|"     The purpose of this study is to evaluate if a supplement containing omega-3 long chain     polyunsaturated fatty acids for three months reduce obesity and insulin resistance to obese     adolescents if administered together with a hypocaloric diet.   "
139695|NCT01456208|"     Thank you for your interest in the investigators Genetics and Blood Pressure Research Study.     The National Institutes of Health are sponsoring us to investigate why patients develop high     blood pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two     parts of the investigators research program. The first part is a screening visit. At this     visit you will be given a brief physical exam and will be asked questions concerning your     medical history. During the same visit you will have your blood drawn for routine screening     and to prepare DNA for genetic testing. You will also be asked to collect a urine sample for     routine screening.      If the doctor finds that you are a healthy candidate you will be invited to participate in     the second part of the study. During Phase II, the investigators will perform physiological     tests after you are placed on a low salt diet and again after you are placed on a high salt     diet. If you are on blood pressure medication, it may be necessary to discontinue taking your     present medication for up to three months before beginning the study. Patients discontinuing     their current blood pressure medication may be placed on a different blood pressure     medication during this washout period if necessary to maintain blood pressure at pre-study     levels. The investigators will take you off all medications at about two weeks prior to your     scheduled in-patient study (overnight visits).      Once your blood pressure medications are discontinued, you will be closely monitored to make     sure you do not encounter any difficulty. If you do not own a home blood pressure monitor,     the investigators will provide one for you to use during the study so that you can keep a     daily record of your blood pressure readings. The investigators will ask you to call us every     three days to report your blood pressure readings. Less than 20% of patients have any     significant increase in their blood pressure during this short time off of therapy. After you     have stopped taking your medication, dieticians at the hospital will make you low salt meals     to eat at home for seven days. On the seventh day of the low salt diet, you will be asked to     begin a 24-hour urine collection that you will bring with you when you are admitted to the     hospital that evening. That morning, you will be required to come to the Clinical Research     Center for a one-hour test to check if your body is in the correct salt balance. You will     return that evening to the inpatient Clinical Research Center where you will be admitted for     your study that will occur the next morning. On the morning of your low salt study, you will     have naturally occurring hormones administered and blood samples drawn from an intravenous     needle. The investigators will also take ultrasound pictures of your heart to see how salt     and hormones affect the way the heart functions. These tests will last approximately five     hours and you will be discharged around 2:00 PM. For the next five days, you will be placed     on a high salt diet. During these five days, you will eat all your own food, but the     investigators will give you some supplements to eat with your meals. After five days on your     high salt diet, on the morning of your second admission to the hospital, you will be asked to     begin a final 24-hour urine collection. That morning, you will again be required to come to     the Clinical Research Center for a one-hour test to check if your body is in the correct salt     balance. You will return that evening to the inpatient Clinical Research Center where you     will be admitted for your final study that will occur the next morning. The same study that     was done for the low salt study will be repeated for the high salt study. You will be     discharged around 2:00 p.m. This study will determine if you are salt-sensitive. In addition,     the investigators hope to learn more about the hormones that regulate your blood pressure and     the genes responsible for regulating those hormones.      You will be placed back on your initial blood pressure medication (if you are on any) and     returned to your regular physician for care. The investigators will provide clinically     relevant information to you and your physician.   "
139696|NCT01456195|"     The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam),     once daily (QD), in participants with type 2 diabetes mellitus (T2DM).   "
139697|NCT01456182|"     This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels     in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The trial     will also determine the impact of dose on quality of life indices and on biological and     immune responses, and will assess if there is a maximum tolerated dose and/or dose-limiting     toxicity in this study population.   "
139698|NCT01456169|"     The purpose of this study is to evaluate the efficacy and safety of the fixed dose     combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily,     in participants with grades 2 or 3 essential hypertension who do not reach target blood     pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.   "
139699|NCT01456156|"     Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some     patients can not receive radical resection. Such patients have high risk of recurrence. Tumor     resection and postoperative radiation is an option for such patients to achieve radical     treatment and radiation may reduce local recurrence.   "
139700|NCT01456143|"     This study examines if certain imaging techniques and devices can aid the surgeon in     detecting cancer during the surgical procedure.   "
139701|NCT01456130|"     The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on     to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2     diabetic patients with inadequate blood glucose control despite treatment with a rapid-acting     insulin secretagogue as well as diet and exercise therapies.   "
139702|NCT01456117|"     The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain     hemodynamics in healthy elderly participants.   "
139730|NCT01455701|"     This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and     safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active     sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on     study treatment is 12 weeks (Main evaluation period). Participants will have the option to     continue tocilizumab treatment until participant reaches 2 years of age or up to one year     from baseline, whichever is longer. An optional extension period will follow the main     evaluation period.   "
139703|NCT01456104|"     This study is being done to see if the investigators can help the immune system to work     against melanoma.      A dendritic cell is another type of white blood cell. It has most, if not all, of the     proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not     normally have the cancer proteins on their surface. The challenge then is to combine the     antigens with dendritic cells to make a vaccine. The investigators think that the body's T     cells might then react against the tumor and help destroy it.      This study will see if altered dendritic cells will make T cells work against tumor cells.     The dendritic cells will be made in a lab and will carry the antigens. These cells then will     be injected under the skin.      In this study, the investigators are trying to help the body make a stronger immune response     against the cancer. The patient will get the same kind of dendritic cell vaccine used in the     earlier study, but with one major difference. The dendritic cells will contain messenger-RNA     (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a     laboratory method called electroporation. The mRNA is never given to the patient directly.     This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses.     The dendritic cell can then put this tumor antigen on its surface so that the body could make     a stronger immune response against the tumor.   "
139704|NCT01456091|"     The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in     increasing the use of long-term contraceptives, in improving adherence to contraceptives and     in preventing rapid repeat pregnancies among parenting adolescents.   "
139705|NCT01456078|"     By improved kidney dosimetry including biological effective dose and taking into account     potential risk factors (especially for kidney toxicity), it might be possible to give an     optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic     neuroendocrine tumor.   "
139706|NCT01456065|"     The purpose of this study is to investigate the safety of the active immune therapy based on     the reiterated injection of fully mature, TERT (Telomerase Reverse Transcriptase)-mRNA and     Survivin-peptide double loaded DCs (Dendritic Cells) [Procure®] in patients with advanced     ovarian cancer, enrolled into the study within twelve weeks after completing primary therapy.   "
139707|NCT01456052|"     This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and     preliminary effectiveness of two blinded dose levels of LX1606 in subjects with acute, mild     to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.   "
139708|NCT01456039|"     The purpose of the study was to assess efficacy, tolerability, safety and pharmacokinetics of     Romidepsin in subjects with progressive or relapsed peripheral T-cell lymphoma   "
139709|NCT01456026|"     Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on     vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular     function remained unknown. Therefore, the aim of our study is to investigate the effects of     heat-treated, glycated beta-lactoglobulins (BLG) on vascular function in subjects with type 2     diabetes mellitus (T2DM) and to compare it to non-glycated, heat-treated BLG.   "
139710|NCT01456013|"     Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems     undergo procedures that use iodinated contrast media, such as cardiac catheterizations.     RenalGuard Therapy was developed to enable the patient to clear the contrast out of their     kidney before it can do significant damage. This study aims to enroll patients with increased     risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will     be randomized to either RenalGuard therapy or standard therapy.   "
139711|NCT01456000|"     The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus     Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial     fibrillation by creating electrical isolation of the pulmonary veins.   "
139712|NCT01455987|"     Osteochondritis dissecans is a relatively common...   "
139713|NCT01455974|"     Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient     in hemodialysis treatment results in absolute sodium removal via diffusive transport of     sodium from the blood to the dialysate, and it may be a potentially useful tool to improve     sodium loading due to excess dietary sodium intake.      The purpose of this study is to determine whether a in small negative sodium gradient could     improve blood pressure level, arterial stiffness and left ventricular hypertrophy in     hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight     assessed by bioimpedance spectroscopy.   "
139714|NCT01455961|"     The aim of this study is to describe the treatment pattern and patient characteristics in     real life setting in patients with Bipolar disorder treated with Seroquel XR and/or Seroquel     IR in Sweden.   "
139715|NCT01455896|"     Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated     with ITCA 650.   "
139716|NCT01455883|"     Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to     metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.   "
139717|NCT01455870|"     Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin     monotherapy in patients with type 2 diabetes.   "
139718|NCT01455857|"     Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior     to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.   "
139719|NCT01455844|"     The purpose of this study is to determine whether CaPre(TM), given at doses 1.0g or 2.0g for     12 weeks, has an effect on fasting plasma triglycerides in patients with mild to high     hypertriglyceridemia as compared to a placebo.   "
139726|NCT01455753|"     The aim of this project is to investigate whether the proximity of employees to flu-shot     clinics will increase the uptake rates of employees participating in these clinics. The     investigators hypothesize that ease of access is an important factor in whether or not     employees receive an influenza vaccination.   "
139731|NCT01455688|"     The aim of the study is to verify the effect of HAART in critically ill HIV infected     patients. The current practice is to begin antiviral therapy after ICU discharge, when the     condition of the patient is more stable. The investigators hypothesis is that the     investigators can improve outcome of these patients with earlier antiviral therapy in the     ICU. The investigators just have retrospective studies in this scenario. After admission to     ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission)     or conventional therapy (initiation of HAART after ICU discharge). The following data will be     collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic     infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be     followed to determine ICU mortality, hospital mortality and 6-month mortality.   "
139720|NCT01455831|"     The human body has a natural stress response to surgery, including the formation of blood     clots. This response to surgery has been shown to increase metastases (the spread of cancer     cells to other organs in the body). These metastases cannot be seen at the time of surgery     but when they grow into new tumors, the cancer has recurred (come back). A blood thinner     called low molecular weight heparin (LMWH) can suppress the development of metastases after     surgery in animal experiments. The investigators want to see if giving patients with     colorectal cancer the blood thinner, LMWH, around the time of surgery can decrease the chance     of their cancer spreading to other organs (metastases) and coming back (recurrence).      The investigators need 1075 patients to answer our scientific question. Patients who give     informed consent will be randomly put into one of two groups, the experimental group and the     control group. The patients in the control group will be treated with LMWH starting a few     hours after surgery and every day until they leave the hospital. This is how most patients     are treated after colon cancer surgery (standard care). The patients in the experimental     group will be treated with LMWH for a longer period of time, starting on the day they agree     to have surgery and continuing for two months after surgery. All the patients will be     followed for at least three years after surgery to find out if their cancer has recurred     (come back). If LMWH treatment around the time of surgery reduces the chance of recurrence in     patients with colorectal cancer, it would improve the health and quality of life for these     patients.   "
139721|NCT01455818|"     Blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological     test called computed tomography (CT scan). As technology advances, the CT scans are able to     detect smaller and smaller blood clots. Over time, the frequency of blood clots in the     pulmonary arteries has increased significantly (CT scan are now detecting very small blood     clots that the investigators could not see before). As a result, more and more people are on     blood thinners to treat these small blood clots but their true clinical significance is     unknown.      The management of blood thinners is costly and also utilizes scarce healthcare resources.     These blood thinners need to be monitored with frequent blood work. Furthermore, every year,     approximately 3 percent of patients on blood thinners will have a major bleeding event     requiring medical attention.      The investigators don't think that treating these small blood clots in the pulmonary arteries     detected on CT scan is worth the risk of bleeding from the blood thinners.      The main goal of this study is to find out if it is safe to not treat very small blood clots     in the pulmonary arteries.      The investigators plan to follow 300 patients with small blood clots in their lungs for 90     days. These patients will not be treated with blood thinners but will be followed closely     with other non-invasive tests to avoid progression or recurrence of blood clots.   "
139722|NCT01455805|"     Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the     lower part of the back. This causes discomfort in the legs when standing or walking because     of pressure on the spinal nerves.There are several treatment options for LSS including     physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy,     Discectomy and more recently devices for interspinous distraction such as the XSTOP® and from     May 2011 Minuteman™.      Surgical decompression for LSS involves the removal of excess bone, ligament, and soft-tissue     allowing more room for the nerves. The operation is usually preformed under general     anaesthetic and with an average stay in hospital for 2-3 nights. Whereas the Minuteman™     implant is preformed as a day case under local or general anaesthetic and involves implanting     the device into the space between two back bones to relieve pressure on the nerves and,     therefore, pain in the legs.      This is a multi centred (four sites) randomised controlled trial with a total sample of 50     participants after obtaining their informed consent. Participants will attend the pain clinic     at the Hospitals for a baseline visit where they will be randomised with a ratio of 1:1 to     receive either the Minuteman™ Interspinous interlaminar fusion Implant or standard surgical     decompression for the treatment of lumbar spinal stenosis (LSS). Following randomisation     arrangements will be made for the participant to receive the randomised treatment. If     allocated to Minuteman™ Implant, the treatment will be conducted by the Pain Specialist     identified at the site. If allocated to surgical decompression, the treatment will be     conducted by the neuro/spinal-surgeon identified at the site. Participates will be followed     up regularly for 60 months post implant to assess clinical efficacy, safety, participants     function and quality of life of each treatment.   "
139723|NCT01455792|"     Background: Prostate biopsies are usually performed due to accidentally discovered elevated     prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal     ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise     documentation concerning the localization of the biopsies are lacking. Therefore, the same     locations might be subject to multiple negative biopsies. There is a growing confidence that     magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade     tumours, and studies have shown value in performing MRI before biopsies. Because image     documentation is lacking, it is not possible to know which region actually being biopsied     with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a     new promising method that will ascertain all regions of the prostate gland to be biopsied,     and it is possible to perform accurate targeted biopsies when combined with MRI.      Aims of the study      Compare the biopsy results in the two groups:        1. To evaluate the overall rate of positive biopsies.        2. To evaluate the rate of re-biopsies.        3. To evaluate the detection rate of Gleason grade 4 and 5 tumours.        4. To evaluate the rate of positive targeted biopsies.        5. To evaluate the rate of positive random biopsies        6. To compare targeted and random biopsies between groups.        7. To compare patient tolerance, time consumption and cost of the two methods.        8. To evaluate the diagnostic accuracy of performing cytological imprints of targeted          biopsies.      Material and methods: A prospective randomized study including 300 consecutive patients     referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies and     image fusion guided biopsy.      All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy     will be obtained in case of positive MRI of ultrasound.   "
139724|NCT01455779|"     The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System in     women most likely to be treated in an office setting for the condition of stress urinary     incontinence, secondary to urethral hypermobility.   "
139725|NCT01455766|"     The hypothesis of this observational single-center clinical study was to explore the     volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic     intervention. The investigators monitored the changes in the volumes of blood in the central     vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e.     extravascular lung water).   "
139769|NCT01455194|"     The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day.     Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).   "
139727|NCT01455740|"     The goal is to improve HIV patients' adherence to medication regimens. The investigators are     planning an intervention in which the patient is given financial incentives to take clinic     attendance seriously, and then given the option to make these incentives contingent on taking     medications as prescribed—that is, to require better behavior from themselves to earn the     same reward. Past studies have shown that conditional payments improve adherence to HIV     treatment, but only while payments are being made. The investigators expect that patients     will be willing to give up some payments to commit themselves to better adherence. The     investigators also hope to see some patients maintaining good adherence after financial     incentives are removed, among those who are given the opportunity to choose this commitment.   "
139735|NCT01455636|"     Low birth weight (LBW) infants are particularly vulnerable to frequent infections and     consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of     complementary foods and ultimately micronutrient deficiencies that result in post-natal     linear growth faltering. The objective of this study is to facilitate improved feeding     practices through the early reduction of infections using the innovative tools of water-based     hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning     at 6 months of age). A community-based cluster randomized controlled trial will be carried     out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at     birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of     the children in each group will be randomized to receive I-MNP. All groups will receive     nutrition and hygiene education from birth to 12 months. Recumbent length is the primary     outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By     working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity     to translate the results directly and quickly into child health programs in Bangladesh.   "
139736|NCT01455623|"     It is necessary for outcome measures to accurately reflect the state of health of a person in     order for clinical trials to show benefit. The most commonly used outcome measure for Charcot     Marie Tooth Disease (CMT) is the CMT Neuropathy Score, which uses cutoffs of points     designated as mild (0-10 points), moderate (11-20) or severe (21-36). These terms are     arbitrary. This study is looking to base mild, moderate, and severe on what both people     affected with CMT and those who provide for people with CMT consider appropriate.   "
139737|NCT01455610|"     The purpose of this multicenter and double-blind clinical trial is to prospectively assess     the sensitivity, specificity, negative predictive value, positive predictive value, and     accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its     various post processing techniques, taking operational and pathological records as the gold     standard.   "
139738|NCT01455597|"     This is an open-label extension study evaluating the long-term safety and efficacy of WC3011     in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.   "
139739|NCT01455584|"     The main objective of this study is to determine the maximum tolerated dose (MTD) of     HM781-36B continuously.   "
139740|NCT01455571|"     The main objective of this study is to determine the maximum tolerated dose (MTD) of     HM781-36B.   "
139741|NCT01455558|"     This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR     (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple     doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers.   "
139742|NCT01455545|"     This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and     prescription count, influences level of asthma control in a sample of patients with severe     and moderate-mild asthma.   "
139743|NCT01455532|"     Primary Objective:        -  To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent          and in combination with chemotherapeutic regimens in patients with advanced solid tumors          that are refractory to standard therapy.      Secondary Objectives:        -  To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid          Tumors [RECIST]) Version 1.1 in patients with measurable disease.        -  To characterize iniparib (and its metabolites, if possible) pharmacokinetics.      Based on data generated by Sanofi, it is concluded that iniparib does not possess     characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been     fully elucidated, however based on experiments on tumor cells performed in the laboratory,     iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of     DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell     lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.     Investigations into potential targets of iniparib and its metabolites are ongoing.   "
139744|NCT01455519|"     You are asked to take part in this study because you have chronic, non-radicular low back     pain. This study is done to investigate the pain relieving effects of the study drug Exalgo     (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose     of this research is to look at how the study drug can be used to benefit people who     experience this type of pain. This is a phase IV study done to study the safety and     effectiveness of the drug. At this point the drug has been approved by the Food and Drug     Administration and has been studied in more than 2,000 pain patients in clinical trials,     including individuals with low back pain. About 36 subjects will take part in this study.   "
139745|NCT01455506|"     This is a single institution study of combining decitabine with fludarabine and busulfan in     the setting of allogeneic stem cell transplantation. A study population of 20 subjects will     be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center.     Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation     according to the eligibility criteria will be consented and enrolled. Subjects will receive     treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to     allogeneic stem cell transplantation. Subjects will be followed until 1 year post     transplantation to assess stability of engraftment, toxicity, progression free survival, and     disease response   "
139746|NCT01455493|"     This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of     GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety,     tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.   "
141000|NCT01438931|"     The purpose of this study is to evaluate the efficacy and the safety of DA-9501     (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation     under monitored sedation care.   "
139747|NCT01455480|"     The objective of this Trial is to evaluate the performance of RPh201 as a treatment for the     healing of partial thickness burns. It is further postulated that deep second degree lesions     will benefit from the RPh201 treatment promoting granulation and epithelialization as well as     wound closure.   "
139748|NCT01455467|"     Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in     conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of     one anti-glaucoma medication prior to stent implantation.   "
139749|NCT01455454|"     Coagulopathy with transfusion requirements is frequent during cardiac surgery with     cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood     point of care test used to assess the patient's coagulation status.      The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence     of very high heparin concentrations as seen during cardiopulmonary bypass.   "
139750|NCT01455441|"     The objective of this study is to investigate the effects of physical training in patients     with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®)     in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.      Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients     when training is combined with liraglutide (Victoza®) treatment.   "
139751|NCT01455428|"     To prove pregabalin is effective in relieving pain compared with placebo in subjects with     postherpetic neuralgia (PHN).   "
139752|NCT01455415|"     This study is to test the effectiveness of pregabalin in treating nerve pain caused by     diabetes. The suitable subjects will be patients who also use an non-steroid     anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.   "
139753|NCT01455402|"     The primary objective of this observational study is to determine the incidence of medically     attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening     cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease     [AECOPD] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with     severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.   "
139754|NCT01455389|"     The goal of phase 1 of this clinical research study is to find the highest dose of     DOTAP:Chol-fus1 that can be safely given in combination with Tarceva (erlotinib     hydrochloride) to patients with NSCLC.      The goal of phase 2 of this clinical research study is to learn if the combination of     DOTAP:Chol-fus1 and erlotinib hydrochloride can help to control NSCLC.      The safety of this drug combination will also be studied in both phases.      DOTAP:Chol-fus1 is a drug that helps transfer a gene called fus1 into cancer cells.     Researchers think that cells without this gene may be involved in the development of lung     cancer tumors. They want to find out if replacing the gene in these cells may keep the tissue     from forming cancer cells.      Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor     growth and survival. This may stop tumors from growing.   "
139755|NCT01455376|"     Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI     disability could stem from cognitive, physical, psychological and social dysfunction which     resulted in significant disability and unemployment. Long-term behavioral impairments which     affected the individual's occupation, lifestyle, and family frequently occurred in     individuals with mild to moderate brain injuries who physically fully recovered. In-vitro and     in-vivo studies showed a better recovery of cognitive function after administration of     exogenous lactate in traumatic brain injury. Therefore, this study is aimed to evaluate the     effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on     cognitive function assessed by Mini Mental State Examination(MMSE)scale.   "
139756|NCT01455363|"     The investigators aim to test the hypothesis and to proof thank to laser speckle contrast     imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in this     case, through a basal cell carcinoma, which will be used as a model of study of tumor     vasculature.      This new concept of tumor perfusion artificial increase could be used in the future for     malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus     decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like     radiotherapy and/or chemotherapy, and increase their efficacy.      This clinical trial will use skin flap model for trunk and facial basal cell carcinoma (BCC),     with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a     little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle     will be clamped with surgical clamp for 3 minutes and clamp released.      In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to     the BCC location.      During all steps of experimentation, laser speckle imaging will be used to measure     continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10     minutes after tumor pedicle clamp or tourniquet release.   "
139757|NCT01455350|"     Chronic gynaecological pain is a major medical problem that affects 20-30% of women at     different moments of their life. This largely neglected issue has a significant impact on the     sexual and conjugal life of women suffering from it as well as on their psychological health.     Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally     ignored. Also, treatment is limited and not extensively studied. This study aims at better     understanding and treating gynaecological pain. The focus of the study will be provoked     vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor     physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The     treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from     provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital,     Royal-Victoria Hospital, CHUM St-Luc).   "
139770|NCT01455181|"     This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in     reducing requirements for supplemental oral calcium and active vitamin D, while maintaining     stable total serum calcium levels in adult subjects with hypoparathyroidism.   "
139808|NCT01454687|"     The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases     associated with skin weakness, blisters, and chronic wounds. Revertant mosaicism means that     there are two genetically different populations of cells due to spontaneous mutations. Some     EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism.     In the revertant areas, the proteins function normally, like non-EB skin. In this study, we     plan to culture cells from the revertant areas and graft them on to the wounded areas.   "
139758|NCT01455337|"     Alcoholic hepatitis represents one of the more serious forms of alcoholic liver disease.     Critically ill patients with alcoholic hepatitis have high morbidity and mortality rate.     Because of data suggesting that the pathogenic mechanisms in alcoholic hepatitis involve     cytokine release and the perpetuation of injury by immunologic process, corticosteroid has     been extensively evaluated in the treatment of alcoholic hepatitis. Although there are     discrepancies in literature as several randomized trials and meta-analyses have reached     contradictory results, corticosteroid for a subset of patients with severe alcoholic     hepatitis, defined as a discriminant function ≥ 32, who also have no concomitant     gastrointestinal bleeding, active infection, renal failure, and pancreatitis, has been     recommended. This latter point emphasizes the important of meticulous selection to avoid the     side effects of corticosteroid. Thus, the beneficial effects seems confined to a highly     selected minority group in which the inhibitory effect of corticosteroid on liver     inflammation is not outweighed by side effects such as weakened defense against infection,     anti-anabolic effects, and possible ulcer-promoting effects causing gastrointestinal     bleeding, which may be deleterious in these critically ill patients.      Newer understanding of the role of the role of TNF-α expression and receptor activity in     alcoholic liver injury has prompted to an examination of TNF inhibition as an alternative to     corticosteroid for severe alcoholic hepatitis. Pentoxifylline, a nonspecific TNF inhibitor,     recently has been demonstrated in a randomized trial to improve survival in the therapy of     severe alcoholic hepatitis. In particular, the survival benefit of pentoxifylline appears to     be related to a significant reduction in development of hepatorenal syndrome. These results     are promising, and support the need to further evaluate the potential of this new therapeutic     avenue.      There is a need for head to head comparison of corticosteroid and pentoxifylline in severe     alcoholic hepatitis. At the time the current study was designed (2008), corticosteroid was     first-line treatment for severe alcoholic hepatitis. This study was designed to demonstrate     that the effect of pentoxifylline was similar (i.e., not inferior) to that of prednisolone,     an active form of prednisone. The aim of the present study was thus to compare the effects of     pentoxifylline and prednisolone on the short-term mortality.   "
139783|NCT01455012|"     Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS)     have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been     shown to effectively reduce the incidence of PLMs in patients with RLS. The current study     aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal     BP elevations associated with PLMs in patients with RLS.   "
139759|NCT01455324|"     The purpose of this study is to work with prosthetists to fit the novel conformable socket     material developed by Infoscitex, to subjects, and determine if it is a viable alternative to     current prosthetic socket liners. During this task, the research team will travel to the     prosthetists locations to have them fit the subject with the conformable woven socket and a     check socket, and provide subjective feedback with regard to comfort and fit for the amputee,     its ease of use, and breathability. The subject will also wear the woven socket for gait     analysis and provide his/her feedback as well.   "
139760|NCT01455311|"     The goal of this study is to compare a sample of the cyst taken by a standard method (fine     needle aspiration) to the sample taken by a new method using a device called the EchoBrush to     see which method is more accurate at diagnosing cancer. We will also look at proteins (also     called biomarkers) in the samples to see if they predict whether or not the cyst is     cancerous.   "
139761|NCT01455298|"     This cohort study will evaluate the prevalence of the infra clinical liver injuries among a     group of adult patients presenting with Alpha-1 AT deficiency followed up in a large     university hospital in Lyon, France.   "
139762|NCT01455285|"     Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve     stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency     modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A     controlled clinical study and prospective developed at the School of Physiotherapy Clinic /     UFPI. Forty students were randomized into four distinct groups of the modulation frequency     TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off),     group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire     developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60     minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration     of TENS application was 20 minutes and all protocols were performed in a single session. The     analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify     differences between experimental groups for each variable analyzed. The level of significance     was p< 0,05.   "
139763|NCT01455272|"     Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only,     option for the treatment of leukemia, particularly for patients with advanced-stage leukemia.     However, relapse rate was still very high for advanced-stage leukemia.      It was found in our previous study that infusion of granulocyte colony-stimulating factor     (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes     exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or     less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was     combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of     fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI     combined with the use of short-term immunosuppressant was feasible in patients with advanced     leukemia to prevent relapse after HLA-mismatched HSCT.      The study hypothesis:      Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood     progenitor cells following hematopoietic stem cell transplantation in patients with     advanced-stage acute leukemia can        -  reduce relapse rate        -  improve survival   "
139764|NCT01455259|"     In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In     Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with     melanoma and patients with other solid tumors will receive AdCD40L in combination with low     dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination     with one local radiotherapy and cyclophosphamide.   "
139765|NCT01455246|"     Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug     resistant bacteria. Standard treatment of SBP could be ineffective. The aim of the study is     to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP.   "
139766|NCT01455233|"     The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and     tolerance when used prophylactically in subjects undergoing routine cataract surgery.   "
139767|NCT01455220|"     The purpose of this study is to determine if sexual dysfunction symptoms and quality of life     measures in patients with Multiple Sclerosis may be improved in patients that are prescribed     Tysabri.   "
139768|NCT01455207|"     This research project aims to identify factors that contribute to the heterogeneity observed     in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators     overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure     and metabolism, and cognition is mainly related to individual differences in pattern of     alcohol use, gene pool, nutritional status and history of withdrawal symptoms.   "
139771|NCT01455168|"     The purpose of this study is to examine the efficacy of a capsular tension ring (CTR) in     preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome (XFS)     with no zonular weakness. The eyes with XFS undergo phacoemulsification and aspiration (PEA)     with an intraocular lens (IOL) implantation. All operations are performed by a single     surgeon. No eyes with either ectopia lentis or phacodonesis are included. There are three     groups; CTR is not used in group A, CTR is simply implanted in group B, and CTR is implanted     and closed by tying both eyelets in group C. The areas of continuous curvilinear     capsulorhexis (CCC) are calculated, and both the time-course change and the comparison among     the 3 groups are tested.   "
139794|NCT01454869|"     This is a prospective randomized clinical trial about the efficacy of heparin nebulization on     lung injury score in inhalation burn injury in Mothary burn hospital. This study would     consist of 170 burn patients with documented inhalation injury in 2 arms (control group and     study group). Allocation ratio is1:1. Masking was not possible. The patients' primary outcome     will be assessed for Lung Injury Scale and the patients' secondary outcome will be assessed     for mortality, Coagulation tests (PT, PTT), ICU and hospital stay and duration of mechanical     ventilation support. Duration of this study is about 32 months.   "
139772|NCT01455155|"     Stroke is one of the common diseases in the elderly. It is the third ranking cause of death     and affects health care system in our country. The focal brain lesions encountered in     patients with stroke can result in impairments in motor function, language, cognition,     sensory processing, cognition and emotional disturbances. All of these conditions affect     performance of functional activities. The abrupt change in the life situation of the stroke     survivor impacts all phases of care. This may reduce a patient's quality of life.      Many innovative therapy techniques have been developed to help the restoration of lost     functions and to aid in prevention and treatment of depression. Music and art therapy has     been used in rehabilitation settings to stimulate brain functions involved in movement,     cognition, speech, emotions, and sensory perceptions. However many research studies on the     use of music and art therapy in rehabilitation of acquired brain injury have suffered from     small sample size, making it difficult to achieve statistically significant results. In     addition, differences in factors such as study designs, methods of interventions, and     intensity of treatment have led to varying results.   "
139773|NCT01455142|"     This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between     two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and     safety obtained with formulation 1 can be assumed identical for formulation 2.   "
139774|NCT01455129|"     Chronic obstructive pulmonary disease (COPD) is one of the commonest respiratory diseases.     During the early stage of COPD, patients only have mild respiratory symptoms or signs which     may lead to under-diagnosis of the disease. Patients may show poor response to treatment at     later stages of the disease, associated with higher mortality and incidence of     re-hospitalization and disability causing burden for both the families and the society.      So far, there is no large-scale clinical trial on long-term intervention with tiotropium     bromide (Spiriva) in patients with early stages of COPD (i.e. GOLD Stage I-II COPD or     asymptomatic COPD). It would be of great significance for COPD prevention and treatment if     the investigators could prove that tiotropium decreases the lung function decline and     reverses disease progression in patients with early-stage COPD.      The investigators objective is to evaluate the efficacy of long-term intervention with     tiotropium in early stage (FEV1 ≥50% predicted) COPD (difference of trough FEV1, number of     exacerbations, time to first exacerbation, quality of life, etc) and relevant     pharmacoeconomic endpoints.   "
139775|NCT01455116|"     Septic shock is in critically ill patients is a condition associated with a high rate of     organ failure and hereto attributable mortality ~45-55% Hypothesis: Mild Induced Hypothermia     reduces the mortality of critically ill patients with septic shock by reducing organ     metabolism, counteracting on microcirculatory thrombosis, genetically downregulating tissue     apoptosis and by reducing bacterial growth rate and toxin production.   "
139776|NCT01455103|"     The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on     the biomarkers measured in the peripheral blood and tumor tissues of subjects with     unresectable Stage III or IV Melanoma.   "
139777|NCT01455090|"     The purpose of this study is to estimate the rate of sustained virologic response (SVR)     SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks     post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1)     infected patients who are prior null responders to pegIFN/ribavirin   "
139778|NCT01455077|"     Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters     (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep     Apnea (OSA) without comorbidities.      However, there is not any study evaluating this system when OSA is associated with morbid     obesity, so the validation of PMS will be very useful in order to properly work-up this     highly risk population.      Objective:      To evaluate the accuracy of level III type of PMS - Stardust™ (STD), on patients with level     II and III of obesity and high clinical suspicion of OSA.      Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be     selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the     following order of recordings:      1) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for     subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.   "
139779|NCT01455064|"     This research study will test a new investigational continuous glucose monitoring system     (System). The purpose of this study is to find out about the performance of the System in a     home use environment over a 15 day period, in people with diabetes.   "
139806|NCT01454713|"     Retrospective data collection of the use of Veritas in breast reconstruction surgery   "
139807|NCT01454700|"     The purpose of the study is to investigate whether the combination of insulin pump therapy     and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to     prevent progression of albuminuria in patients with type 1 diabetes   "
139838|NCT01454297|"     The primary objective of this observational study is to identify the molecular profiles and     clinical characteristics that define subsets of myeloma patients during the course of the     disease.   "
139780|NCT01455051|"     A good proportion of patients with chronic lymphocytic leukemia (CLL) can be managed     effectively with palliative chemotherapy. However, there is a group of younger patients with     poor risk disease whose life expectancy is significantly reduced. As a result, reduced     intensity conditioning (RIC) allogeneic hematopoietic cell transplantation (allo-HCT) has     been investigated as a potentially curative procedure.      Recently, the European Group for Blood and Marrow Transplantation (EBMT) published a set of     guidelines suggesting situations where allo-HCT might be considered a therapeutic option for     CLL patients. Their conclusions were that allo-HCT was reasonable for younger CLL patients     refractory to fludarabine, relapsing within two years of intensive treatment, or with p53     abnormalities requiring treatment.      However, the results with RIC allo-HCT are not entirely satisfactory, and progression-free     survival after allo-HCT revolves around 35-40% at 3-5 years following allo-HCT. This is due     to non-relapse mortality, which is significantly associated with the development of     graft-versus-host disease (GVHD), but also due to disease relapse. These relapses may occur     early in the course of the transplantation, like any other hematological malignancy, but late     relapses have also been reported.      Several strategies have been tested in order to improve these results. The anti-CD20     monoclonal antibody rituximab, given concomitantly with allo-HCT or donor lymphocyte     infusions, may reduce graft-versus-host disease and facilitate disease control. This may be     due, not only to direct cytotoxicity, but also to modulation of GVHD and the graft-versus CLL     effect (GVCLL). Interestingly, rituximab has been shown to promote the cross-presentation of     tumor-derived peptides by antigen-presenting cells, thus enhancing the formation of cytotoxic     T-cell clones and a GVCLL effect. With the addition of rituximab to the conditioning regimen,     rates at 4 years for current progression-free survival (CPFS) and overall survival were 44%     and 48%.      The investigators hypothesize that ofatumumab, having a more potent anti-CLL activity and     complement-dependent cytoxicity than rituximab, could improve disease control and modulate     the GVCLL effect more effectively, thus reducing the GVHD rate and subsequently improving the     non-relapse mortality and progression-free survival in the long term.   "
139781|NCT01455038|"     The purposes of this study were: (1) to compare heart rate variability between bipolar     patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation     between the severity of subsyndromal depressive symptoms and reduced heart rate variability.   "
139782|NCT01455025|"     This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony     stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute     myeloid leukemia .   "
139784|NCT01454999|"     This project aims to enhance the emotional and physical well-being of veterans through the     reduction of smoking by utilizing a web-based, computerized tailored intervention (CTI) with     feedback messages delivered via cell phone. CTIs have shown increasing promise as useful     behavior change programs for improved health behaviors. A variety of modalities are to     deliver personalized CTI information and feedback; however, the ubiquity and sophistication     of today's wireless mobile technologies represent new modes of delivery for empirically based     smoking cessation and other behavioral health interventions. The CTI is based on the     empirically-supported Transtheoretical Model of Behavior Change (TTM). A web-based CTI     modified for a veteran population will be used to pilot test the effectiveness of the CTI     alone and CTI plus individualized text messaging enhancements. The pilot study is a     randomized controlled trial to assess the cell phone's feasibility as an intervention     modality for changing smoking behaviors. This will be the first study to adapt a smoking     cessation Internet-based CTI to provide personalized feedback on a cell phone to reduce     smoking behaviors in military veterans.   "
139785|NCT01454986|"     The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose     of ALXN1007 in healthy volunteers.   "
139786|NCT01454973|"     A multi-year clinical study to improve tools for measuring the function of insulin-producing     beta cells in people with type 2 diabetes mellitus.   "
139787|NCT01454960|"     Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of     multi-drug resistant pathogens may be encouraged by provider prescribing behavior.     Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum     antibiotics can lead to the development of resistant strains. Though providers are adequately     trained to know when antibiotics are and are not comparatively effective, this has not been     sufficient to affect critical provider practices.      The intent of this study is to apply behavioral economic theory to reduce the rate of     antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for     antibiotics. Specifically targeted are infections that are likely to be viral.      The objective of this study is to improve provider decisions around treatment of acute     respiratory infections.      The participants are practicing attending physicians or advanced practice nurses (i.e.     providers) at participating clinics who see acute respiratory infection patients. A maximum     of 550 participants will be recruited for this study.      Providers consenting to participate will fill out a baseline questionnaire online. Subsequent     to baseline data collection and enrollment, participating clinic sites will be randomized to     the study arms, as described below.      There will be a control arm, with clinic sites randomized in a multifactorial design to up to     three interventions that leverage the electronic medical record: Order Sets that are     triggered by EHR workflow containing exclusively guideline concordant choices (SA, for     Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions     that populate the note with provider's rationale for guideline exceptions ; and performance     feedback that benchmarks providers' own performance to that of their peers (PC, for Peer     Comparison).      The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and     changes in prescribing rates over time.      The intervention period will be over one year, with a one-year follow up period to measure     persistence of the effect after EHR features are returned to the original state and providers     no longer receive email alerts.   "
139788|NCT01454947|"     Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of     multi-drug resistant pathogens may be encouraged by provider prescribing behavior.     Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum     antibiotics can lead to the development of resistant strains. Though providers are adequately     trained to know when antibiotics are and are not comparatively effective, this has not been     sufficient to affect critical provider practices.      The intent of this study is to apply behavioral economic theory to reduce the rate of     antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for     antibiotics. Specifically targeted are infections that are likely to be viral.      The objective of this study is to improve provider decisions around treatment of acute     respiratory infections.      The participants are practicing attending physicians or advanced practice nurses (i.e.     providers) at participating clinics who see acute respiratory infection patients. A maximum     of 550 participants will be recruited for this study.      Providers consenting to participate will fill out a baseline questionnaire online. Subsequent     to baseline data collection and enrollment, participating clinic sites will be randomized to     the study arms, as described below.      There will be a control arm, with clinic sites randomized in a multifactorial design to up to     three interventions that leverage the electronic medical record: Order Sets that are     triggered by electronic health record (EHR) workflow containing exclusively guideline     concordant choices (SA, for Suggested Alternatives); Accountable Justifications triggered by     discordant prescriptions that populate the note with provider's rationale for guideline     exceptions (AJ); and performance feedback that benchmarks providers' own performance to that     of their peers (PC, for Peer Comparisons).      The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and     changes in prescribing rates over time.      The intervention period will be over one year, with a one-year follow up period to measure     persistence of the effect after EHR features are returned to the original state and providers     no longer receive email alerts.   "
139789|NCT01454934|"     This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety     of eribulin with TPC in subjects with advanced and disease progression following at least two     prior regimens for advanced disease, which should have included a platinum-based regimen.   "
139862|NCT01453985|"     This is a prospective study to extensively evaluate subjective patient parameters on quality     of life, reflux-symptoms, side effects, medication-use and measurements of esophageal     manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.   "
139790|NCT01454921|"     This study will develop/adapt a culturally appropriate secondary prevention intervention for     young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups,     evaluate its acceptability and feasibility, make appropriate modifications, and manualize the     intervention in preparation for a full-scale randomized trial.      Once the intervention is developed/adapted, the sites will pilot the interventions twice to     enable modifications. The intervention aims to address the following concerns: 1) reducing     the risk of young women infected with HIV transmitting the virus to their sexual partners,     and 2) preventing young women infected with HIV from re-infection with a new viral strain or     co-infection with another sexually transmitted disease (STD). Data will be collected to     assess the feasibility and acceptability of the newly developed intervention using both     quantitative and qualitative methods at each iteration.   "
139791|NCT01454908|"     The objective of this study is to compare the effect on gait of unicompartmental knee     arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.   "
139792|NCT01454895|"     The purpose of this project is to compare the effectiveness of several approaches to     influencing hearing protector use. The goals of this study are to further develop an     intervention to promote farmers' use of hearing protectors, and compare the effectiveness of     the developed intervention with two alternative approaches to influencing hearing protector     use behavior, delivered in various combinations. This study will determine if significant     change in hearing protection use can be achieved in a one-shot web-based or protector-supply     intervention. Results will determine the need for future program modifications, e.g.,     inclusion of booster(s).   "
139793|NCT01454882|"     Although instruments such as pedometers and heart rate monitors are helpful for those who use     exercise to maintain their weight, they do not actually measure calories expended, which is a     critical piece of information necessary for sustained weight management. The purpose of this     study is to determine the accuracy of a new device that measures calories burned based upon     heat produced by the body. Since heat production is directly proportional to calories burned,     this device has the potential to accurately measure energy expended in many different     settings.   "
139795|NCT01454856|"     This study consists of evaluations, using blood tests, various immune, inflammatory and     coagulation parameters in the perioperative settings (different substudies), without changing     anything to what is expected.      This will allow us to clarify the possible impact of surgery and analgesia on perioperative     activation of these pathways.   "
139796|NCT01454843|"     The purpose of the study is to compare the results of LASIK surgery when using Alcon     Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided     excimer laser system in patients with nearsightedness with and without astigmatism.   "
139797|NCT01454830|"     The purpose of this study is to examine the feasibility of a tailored (i.e., individualized)     intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in     adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.   "
139798|NCT01454817|"     The purpose of this study is to better understand symptoms and quality of life in patients     with heart disease and implantable defibrillators (ICDs).   "
139799|NCT01454804|"     The goal of this clinical research study is to find the highest tolerable dose of the     combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients     with advanced cancer. The safety of the drug combinations will also be studied.      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for     tumor growth. This may prevent or slow the growth of cancer cells.      Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2     proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors.      Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking     proteins inside the cancer cell, called the Her2/neu receptor.   "
139800|NCT01454791|"     The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on     injection site reaction following self-administer glatiramer acetate in people with Multiple     Sclerosis.   "
139801|NCT01454778|"     This is a single, one time, limited dose infusion of Paclitaxel, that will potentially     prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control     group at 10 months.   "
139802|NCT01454765|"     Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex     and therefore limits genetic research approaches in biomedical models. To overcome this     problem experimental generation of haploid stem cells has been done in animals. The     investigators aim at generating haploid stem cells from human germ cells that are a useful     tool in genetic research and screening.   "
139803|NCT01454752|"     Although the risk of malaria is greatest in early childhood, significant numbers of     schoolchildren remain at risk from malaria infection, clinical illness and death. By the time     they reach school, many children have already acquired some clinical immunity and the ability     to limit parasite growth, and thus most infections are asymptomatic and will go undetected     and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and     learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage     may bring education, as well as health, benefits.      Intermittent parasite clearance (IPC) delivered through schools is a simple intervention,     which can be readily integrated into broader school health programmes, and may usefully     supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a     policy of universal coverage of nets.      This study seeks to establish whether intermittent parasite clearance undertaken once a year     at the end of the malaria transmission season can reduce malaria parasite carriage and     anaemia amongst school-going children already using insecticide-treated nets, and its     consequent impact on school attendance and performance, in order to assess its suitability     for inclusion as a standard intervention in school health programmes in areas of seasonal     malaria transmission.   "
139804|NCT01454739|"     The primary objective of the study is to evaluate the long-term safety of recombinant human     Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary     objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and     treatment of bleeding episodes in participants with hemophilia A.   "
139805|NCT01454726|"     The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in     patients with Meniere's disease.   "
139809|NCT01454674|"     The investigators have designed a three dose level, cross-over vegetable feeding study using     expertise from nutritional sciences and plant sciences to:        1. Implement a randomized vegetable feeding trial among overweight post- menopausal women        2. Produce, in a controlled environmental setting, vegetable crops which provide a selected          variety and quantity of carotenoid and nutrient exposure        3. Assess changes and hopefully demonstrate a significant reduction in oxidant stress and          inflammation in this population at risk for developing chronic disease   "
139819|NCT01454544|"     The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet     given once daily compared to a placebo tablet in the treatment of house dut mite allergic     rhinits.      Additionally the secondary objective of the trial is to evaluate the safety and tolarability     of the ALK house dust mite tablet.      Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite     induced allergy. This trial is planned to investigate if clinically relevant improvements in     rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects     with a history of poor didease control despite of use of symptomatic medications.   "
139820|NCT01454531|"     The purpose of this study is to assess the tolerability of AVANZ.   "
139810|NCT01454661|"     Probiotics are live microbes which, when administered in sufficient amounts, confer a health     benefit to the host. According to recent clinical trials, administration of probiotics to     very low birth weight infants significantly reduces overall mortality and risk of necrotizing     enterocolitis, a devastating inflammatory intestinal disease. The investigators have     previously demonstrated that administering probiotics to the lactating mother enhances the     immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic     intervention is yet to be established. The mechanisms by which probiotics exert their effects     remain largely unknown.      This research project is based on the notion that modulation of early microbial contact by     probiotics may provide a safe and effective means to improve the health of preterm infants.     In particular, the investigators hypothesize that the protective potential of probiotics may     be enhanced via breast milk by administering probiotics to the lactating mother. All of the     potentially beneficial effects of probiotic bacteria are strain-specific and therefore     preliminary laboratory and clinical research with regard to different physiological targets     of probiotic intervention should be carried out to guide the design of large-scale clinical     trials aiming show clinical efficacy and establish clinical practice. The purpose of this     research project is to identify targets for probiotic therapy in premature neonates and to     provide insight into the optimal probiotic strains and administration protocol the clinical     efficacy of which will subsequently be tested in a randomized controlled trial.      The specific aims of the project are:        1. To determine the effect of maternal consumption of probiotics during lactation on          immunomodulatory properties of breast milk in mothers of premature infants.          Concentrations of immunomodulatory factors and microbiological properties of breast milk          will be measured.        2. To investigate the impact of different probiotic administration protocols on gut          microbiota composition in preterm infants. In particular, the issue whether maternal          probiotic consumption instead or in addition to probiotics administered to the infant is          effective will be elucidated. Different potential probiotic strains will be assessed.        3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or          directly to the infant on gut immunophysiology in preterm infants.   "
139811|NCT01454648|"     The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment     methods on traumatic brain injury (TBI) patient prognosis.   "
139812|NCT01454635|"     The purpose of this study is to predict and visualize sertraline treatment response in major     depressive disorder with clinical symptoms, demographic and stress state, personality, eight     genetic polymorphisms at baseline.   "
139813|NCT01454622|"     The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)     tablets of canagliflozin and metformin immediate release (IR) in comparison with the     individual components of canagliflozin and metformin IR.   "
139814|NCT01454609|"     With thyroid surgery being performed as an ambulatory procedure, most recent studies     concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral     superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep     cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the     investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine     in thyroidectomy, as preemptive analgesia.      The hypothesis was bupivacaine with the addition of clonidine would help in reducing     postoperative pain and thereby reduce the need for postoperative analgesia.   "
139815|NCT01454596|"     Background:      The NCI Surgery Branch has developed an experimental therapy for treating patients with     gliomas that involves taking white blood cells from the patient, growing them in the     laboratory in large numbers, genetically modifying these specific cells with a type of virus     (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.     This type of therapy is called gene transfer. In this protocol, we are modifying the patient     s white blood cells with a retrovirus that has the gene for anti-EGFRvIII incorporated in the     retrovirus.      Objective:      The purpose of this study is to determine a safe number of these cells to infuse and to see     if these particular tumor-fighting cells (anti-EGFRvIII cells) are a safe and effective     treatment for advanced gliomas.      Eligibility:      - Adults age 18-70 with malignant glioma expressing the EGFRvIII molecule.      Design:      Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo     a history and physical examination, scans, x-rays, lab tests, and other tests as needed      Leukapheresis: If the patients meet all of the requirements for the study they will undergo     leukapheresis to obtain white blood cells to make the anti-EGFRvIII cells. {Leukapheresis is     a common procedure, which removes only the white blood cells from the patient.}      Treatment: Once their cells have grown, the patients will be admitted to the hospital for the     conditioning chemotherapy, the anti-EGFRvIII cells, and aldesleukin. They will stay in the     hospital for about 4 weeks for the treatment.      Follow up: Patients will return to the clinic for a physical exam, review of side effects,     lab tests, and scans every month for the first year, and then every 1-2 months as long as     their tumors are shrinking. Follow up visits will take up to 2 days.   "
139816|NCT01454583|"     In Germany nearly half of the population present elevated values of blood pressure, with - as     a result of lifestyle factors and a growing average age - further increasing numbers.      Consequences of arterial hypertension may be cardiovascular diseases, cerebrovascular events,     and renal insufficiency. Thus, hypertension therapy focuses on the reduction of these     complications.      The aims of the 3A-registry are the characterization of outpatients with hypertension, their     diagnostic procedures and medical treatment (esp. with renin inhibitors), therapy compliance     and success, clinical events, and an assessment of overall guideline adherence in the     treatment of these patients.      Patients fulfilling the relevant criteria are enrolled and followed up by their general     practitioner or medical specialist.   "
139880|NCT01453751|"     This will be an open-label, non-randomized, multi-center, patient sponsored study of     Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment     safe and 2) Is treatment effective in improving the disease pathology of patients with     diagnosed Type II Diabetes Mellitus.   "
139817|NCT01454570|"     It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to     many secondary medical problems such as diabetes and insulin resistance, obesity,     constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of     life, and more. The ReWalk-I exoskeleton walking device permits investigation of the     potential benefits of frequent upright posture and walking on many of the secondary     consequences of spinal cord injury. The researchers are investigating the ability of persons     with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright     and walking on several of these secondary medical consequences of spinal cord injury.   "
139818|NCT01454557|"     Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an     external stimuli. The aim of this system is to maintain homeostasis.The variability implies     on the interaction between the sympathetic and the parasympathetic systems to maintain the     ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be     a damage to the Central Nervous System (CNS) function. The damages described in the     literature are cognitive, motor and behavioural function, while there is less relation to the     autonomic system. The autonomic system can influence the ability of patient with ABI to     participate in the rehabilitation program. The aim of this work is to investigate the     activity of the autonomic system activity as manifested by HRV among patients with ABI in     different conditions: resting, during activity and while listening to different auditory     stimuli.   "
139823|NCT01454492|"     Allergic rhinitis is a complex chronic inflammatory disease, it always presents with nasal     obstruction, nasal itching, sneezing and runny nose. Whether in adults or children, rhinitis     is a complex disease. The prevalence of allergic rhinitis in Taiwan is about 24-29%. Taiwan     is a developing country. It is a hot and humid country. In developing countries,     industrialization, air pollution makes the constantly increasing number of patients with     rhinitis. Penghu in 1994 for children aged 7 to 14 by the study found that among 7599 people,     1766 people have allergic rhinitis, about 23.2%. Allergic rhinitis is a complex chronic     disease. So, it become a diagnostic challenge, its prevalence always underestimated. The     prevalence of rhinitis has increased in recent years. The phenomenon of underestimate is     caused by variety of personal and environmental factors. Allergic rhinitis had increased     direct and indirect social and economic burden.      Geographic tongue is a benign tongue performance. Geographic tongue has been reported their     relevance to allergy. Geographic tongue is a chronic tongue situation. The causes of     geographic tongue still remains unknown. Allergic rhinitis is a diagnostic challenge to     clinicians. The investigators hope that geographic tongue could play a role in the diagnostic     of allergic rhinitis. The prevalence of geographic tongue in the United States is about 1.8%,     white Americans and Mexicans have a higher incidence rate. This study will investigate the     relevance between allergic rhinitis and geographic tongue. The investigators will analyze the     relevant gender, age, severity of inspection reports. The research results wound provide an     important reference to the diagnosis of allergic rhinitis.   "
139824|NCT01454479|"     Endometrial cancer (EC) is the 8th most common female cancer in Taiwan. Its incidence is     increasing in the recent few years, around 1,200 new cases per year. The outcome of recurrent     EC is disappointing, except focal recurrences that could be irradiated or removed.     Chemotherapy is currently the most common salvage treatment for recurrent endometrial cancer.     However, the response rate (RR) to 2nd-line treatment is approximately 0-27.3%, with short     median time to progression, 2-3.9 months and low overall survival, 6.4-11 months.      Due to progress of studies on the molecular and genetic basis of cancer and cellular     signaling pathways, targeted therapy has been developed for various cancer treatments. A     Gynecologic Oncology Group study found 44% of advanced endometrial cancer had HER>=2+ and the     ratio of HER2:chromosome 17 (CEP17) >=2. Another study showed that HER>=2+ was seen in 47% of     carcinosarcoma. These evidences indicated HER2 gene amplification and HER2 overexpression     occur in endometrial cancer and carcinosarcoma, especially in those of high grade and     recurrence. Lapatinib (L), an oral inhibitor of both EGFR(epidermal growth factor receptor)     and HER2(human epidermal growth receptor), has been shown to be an effective treatment in     HER2/neu overexpressing metastatic breast cancer. Ixabepilone is a semisynthetic analog of     the natural product epothilone B, and recently has been approved by US Food and Drug     Administration as a treatment option in metastatic breast cancer. It was also observed that     lapatinib + ixabepilone killed more breast tumor cells than trastuzumab + paclitaxel in     vitro. Two GOG(Gynecologic Oncology Group) studies had reported that weekly Ixabepilone as     2nd-line chemotherapy provided a similar RR to 3-weekly regimen of 14.3% in platinum- and     taxane-resistant epithelial ovarian cancer with less severe toxicities. The combination of     lapatinib and ixabepilone is expected to become an effective treatment for recurrent     endometrial cancer and carcinosarcoma, but the ideal dose is yet to be surveyed.   "
139825|NCT01454466|"     To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal     breaks related to induction of a posterior vitreous detachment   "
139826|NCT01454453|"     Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and     distressing symptoms in older people. Although these drugs can be beneficial, they are     associated with side effects, particularly in patients with dementia and schizophrenia- like     illness. There is an urgent clinical need to understand why this is the case, to guide     treatment strategies.      This study aims to utilise brain imaging techniques that measure the action of antipsychotic     drugs in the brain to explore the causes of this susceptibility in older people with dementia     and schizophrenia-like illness, and translate these findings into direct patient benefit.      The aim of the study is to investigate and compare the relationship between the action of     amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient     groups - Alzheimer's disease and schizophrenia-like illness. Imaging data will be combined     with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom     reduction and motor side effects) during dose titration.Dose-response modelling will be     carried out in both groups to establish the minimum clinically effective dose of amisulpride,     optimum dose range and impact of variability and covariates on exposure-response     relationships   "
139827|NCT01454440|"     Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33     mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin     according to the ESPRIT protocol vs placebo plus unfractioned heparin.   "
139828|NCT01454427|"     Impedance aggregometry (IA) (Multiplate®)is a new whole blood platelet function test with     potential use in anesthesia and intensive care. Most anesthetic drugs have been shown to have     in vitro antiplatelet activity. The goal of this in vitro study is to evaluate the effect of     several drugs, frequently used in cardiac anesthesia and intensive care, on platelet function     as measured by IA   "
139881|NCT01453738|"     This trial is planed to study if allogeneic mesenchymal stem cells would be safe and     beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of     stem cells will be used in this study.   "
139829|NCT01454414|"     The high risk of acquiring tick-borne diseases by outdoor workers is well documented. Workers     most at risk include, foresters, park rangers, land surveyors and other outdoor workers have     frequent exposure to tick-infested habitats. Many North Carolina state employees with outdoor     occupations report multiple tick bites each year, which indicates that existing tick     preventive strategies may be ineffective. The principal goal of this study is to assess     whether the use of long-lasting permethrin impregnated uniforms can reduce the number of tick     bites sustained by North Carolina outdoor workers.   "
139830|NCT01454401|"     The LeucoPatch™ study goal is to investigate whether the fully autologous growth     factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic     foot ulcers. The study seeks to gather data for comparison with previous data from similar     wounds (historical controls). By subgrouping of the treated wounds (similar to the historical     controls used) an assessment of which of the patient and wound-related factors that might     indicate a beneficial effect of LeucoPatch™ is sought.   "
139831|NCT01454388|"     In addition to bowel cleansing agents, the current practice of bowel preparation for     colonoscopy involves a low residue diet 48 hours prior to and a clear fluid diet the day     before the procedure. This study aims to test whether patients who consume a low residue     breakfast the day prior to colonoscopy have a difference in the quality of their bowel     preparation. Patients requiring outpatient colonoscopies will be asked to participate. They     will be randomized to either breakfast or no breakfast the day before the procedure. Colon     cleanliness, patient hunger, and tolerance will be assessed.      The investigators hypothesize that there will be no difference in bowel preparation scores     and will be better tolerated   "
139832|NCT01454375|"     Tobacco smoke claims approximately 6000 lives annually in BC. In this study, the     investigators will determine whether referring smoking patients from the Vancouver General     Hospital Emergency Department to the investigators provincial QuitNow smoking cessation     service will lead to improved patient outcomes, including number of cigarettes smoked, any     quit attempts, and actual smoking cessation.      Participants in the usual care arm will receive standard care. Participants in the     intervention arm will be eligible for referral to QuitNow Services, where telephone     counseling will be offered. Further follow-up on all enrolled patients will be conducted at     1, 3, 6, and 12 months to re-assess smoking status.      The investigators hypothesis is that the intervention arm will have a higher quit rate that     the control arm.   "
139833|NCT01454362|"     Study rationale: Sensory/behavioural elements of smoking play a role in smoking behaviour and     may have a potential to assist smoking cessation. Among current treatments for smokers, only     the nicotine inhalator is attempting to address such factors. The inhalator's efficacy does     not exceed that of the other NRT products, but it mimics the relevant sensory input to only a     limited extent, and its nicotine delivery is dependent on intensive puffing. Recently a new     product, the Electronic Cigarette (E-C) has become available, which provides a more realistic     behaviour and sensory replacement for smoking and can provide good nicotine levels with less     effort.      Primary objective: To compare E-C and nicotine inhalator in their effects on tobacco     withdrawal symptoms over 24hr abstinence.      Hypotheses: E-C will be more effective than the inhalator in reducing withdrawal symptoms and     craving and elicit more favorable user ratings. It will also provide higher nicotine levels.      Study design: In a cross-over study, participants will be randomized to the sequence of     conditions and provide baseline measures and samples for salivary cotinine analysis. They     will be asked to abstain from smoking their usual cigarettes and use the allocated product     over 24 hours. They will return to the study centre the following day, and complete measures     of craving and withdrawal, ratings of subjective and sensory effects of the products, product     satisfaction, and adverse effects. They will also provide saliva samples for cotinine     analysis. Abstinence from smoking will be verified with CO readings.   "
139834|NCT01454349|"     The purpose of this study is to evaluate the safety, tolerability and efficacy of a single     treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to     placebo.   "
139835|NCT01454336|"     Liver cirrhosis (LC) is the final destiny in chronic liver disease. Liver transplantation is     the only effective therapy available to these patients. However, limited number of donors,     post surgical complications, immunological rejection, and financial considerations are it`s     essential problems. The immuomodulatory impact of MSCs in fibrosis was confirmed, and several     clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research     the investigators will study the affect of MSCs and Pioglitazone in the process of fibrosis.   "
139836|NCT01454323|"     Phase II clinical trial which will include all patients diagnosed with chronic anterior     myocardial infarction (more than 6 months from the acute phase and the complete     revascularization in which it is assessed the evolution of left ventricular function in     patients to the monitoring against their own basal condition.      Included patients will be studied in the following conditions:        -  Basal condition: defined as the immediately preceding to the administration of cell          therapy treatment.        -  Monitoring Condition 1: three months after drug administration of cell therapy. Includes          non-invasive methods of exploration of ventricular function.        -  Monitoring Condition 2: six months after administration of treatment. Includes the same          methods of exploration of ventricular function practised in the basal condition,          including cardiac catheterism as well as non invasive methods.        -  Monitoring Condition 3: twelve months after administration of the cell therapy drug.          Includes non-invasive methods of exploration of ventricular function.      The trial hypothesis we propose consists of mononuclear cells of bone marrow providing     progenitor cells with regenerative capacity and also secreting several angiogenic factors,     and their implantation into ischemic tissues should contribute with both elements to the     angiogenesis and tissue regeneration with myocardial functional recovery   "
139837|NCT01454310|"     The purpose of the study is to compare an acellular epithelial skin substitute with     autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective     is to evaluate skin quality and scar formation by using subjective and objective burn scar     assessments in order to present valuable data for another additional option of wound coverage     in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial     skin substitute is at least not inferior to autologous skin grafts.   "
139902|NCT01452503|"     Evaluation of preference for three female condoms (FC).   "
139839|NCT01454284|"     The purpose of this study is:        -  To compare the blood sugar control on LY2605541 with insulin glargine after 52 weeks of          treatment.        -  To compare the number of nocturnal low blood sugar episodes on LY2605541 with insulin          glargine during 52 weeks of treatment.        -  To compare the number of patients on LY2605541 reaching blood sugar targets without low          blood sugar episodes at night to those taking insulin glargine after 52 weeks of          treatment.        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin          glargine after 52 weeks of treatment   "
139840|NCT01454271|"     The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to     be less than 1% but remains a severe and costly complication, source of morbidity and even     mortality. The biofilm forms very early after the bacterial contamination of the prosthesis     and poses a number of clinical challenges due to his resistance to immune defence mechanisms     and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS)     is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene     sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also     proved his biocompatibility and osseous-integration.   "
139841|NCT01454258|"     This study evaluates which substitution solutions are used in daily clincal practice in     various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region).     Furthermore the indication for usage of these solutions is investigated.   "
139842|NCT01454245|"     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of     a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The     effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335     will also be evaluated during the study.   "
139843|NCT01454232|"     Gut microbiota ecology is altered in obesity and could link obesity and its complications.     Bariatric surgery enables a major and sustained weight loss therefore improving obesity     related disease.      the investigators primary aim is to evaluate gut microbiota adaptation to weight loss and the     specific role of energetic restriction. Furthermore we aim to compare gut flora of obese     patients post bariatric surgery to that of lean healthy volunteers.      Thus, the investigators plan to compare gut microbiota from 140 obese individuals before and     after either restrictive (gastric banding) procedures or gastric bypass procedures to that of     40 lean healthy volunteers at baseline.   "
139844|NCT01454219|"     This study aims to determine the glycemic index, glycemic load and insulin index of eleven     Fazer bakery and confectionary products.   "
139845|NCT01454206|"     The Goal of this project is to integrate a previously-tested internet-facilitated Screening,     Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use     into a large network of primary care offices, the Pediatric Practices of Children's Hospital     Boston (PPOC).   "
139846|NCT01454193|"     The objectives of the data search is to find out if there is correlation between pre, post     serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and     associated changes in pre and post systolic and diastolic blood pressure, mean arterial     pressure, number of blood pressure medications and adherence to 3 times per week dialysis,     mortality.   "
139847|NCT01454180|"     The purpose of this study is to determine the proportion of patients alive after 12 months of     the beginning of the trial in patients with advanced pancreatic carcinoma individually     selected and grouped according to the expression in tumor tissue for therapeutic targets.   "
139848|NCT01454167|"     Objective- The purpose of this study is to evaluate a connection between     PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacuum drains of different plastic     operational wounds and its relation to infections and seroma formation.   "
139849|NCT01454154|"     This is a randomized, double-blind, placebo-controlled, multi-institutional study of IV     RP-1127 (Glyburide for Injection) begun within 10 hours of complicated mild, moderate or     severe traumatic brain injury (TBI).   "
139850|NCT01454141|"     Depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative     thinking styles; these patterns themselves are thought to result from a combination of     decreased attentional control, decreased executive functioning, and increased negative     affect. Specifically, the dorsolateral prefrontal cortex has been hypothesized to play a     central role in emotion regulation by recruiting resources necessary for executive control.     Recent advances have been made in neurobehavioral training strategies as interventions for     emotional disorders such as depression. Cognitive control training (CCT) uses computer-based     exercises to recruit and activate prefrontal neural networks via repeated behavioral     exercises, with the aim of strengthening cognitive and emotional functions. A previous study     found that severely depressed participants who received CCT exhibited reduced negative affect     and rumination as well as improved focus and concentration. The present study aimed to extend     this line of research by employing a more stringent control group and testing the efficacy of     three sessions of CCT over a two-week period in a community population with depressed mood.     Forty-eight participants with high BDI-II scores were randomized to CCT or a comparison     condition (Peripheral Vision Training; PVT). The investigators hypothesized that relative to     a control condition (PVT), CCT would be associated with less self-reported negative mood and     emotional reactivity.   "
139863|NCT01453972|"     The main purpose of our study is to examine the physiological adaptations in oxygen transport     chain for high-intensity exercise and moderate exercise in overweight and obese humans. The     main goals are:        1. To investigate the most effective short-and long-interval training in terms of VO2max,          pulmonary diffusion, cardiac output, endothelial function and mitochondrial function.        2. How these physiological adaptations affect the aerobic endurance and performance, and          how this training can reduce the risk of cardiovascular diseases related to overweight          and obesity.   "
139864|NCT01453959|"     The main hypothesis of this study is look for a clinical and fast test to identify salt     sensitivity by administration of fludrocortisone.   "
139865|NCT01453946|"     A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.   "
139903|NCT01452490|"     The purpose of this study is to evaluate the V-Raser diode laser system with investigational     Nail Fungus Handpiece in the treatment of onychomycosis.   "
139851|NCT01454128|"     Heart failure (HF) is a complex syndrome characterized by myocardial dysfunction and an     impaired regulatory function of multiple organ systems which were resulted from impaired     cardiac output and consequently impaired perfusion of target organ. In cardiopulmonary     exercise test (CPET), the investigators found there is periodic oscillation in minute     ventilation of some patient. With periodic breathing (PB), clear oscillations in oxygen     uptake, carbon dioxide output, tidal volume and left ventricle ejection fraction (LVEF) were     also noted. Exertional hyper-ventilation that is caused by HF may further induce     vasoconstriction during exercise and lead to further dysfunction of end-organ and muscle.     Reduced end-organ perfusion/oxygenation may critically limit exercise performance. Hypoxic     change during nadir phase of PB may deteriorate the exercise limitation. Physical training     can have beneficial effects which can effectively counteract the progression of deleterious     compensatory mechanisms of HF. Whether exercise yields the same beneficial effect on     ventilation oscillation and inefficacy is not clear.      The investigators will observe the real-time cardiac and hemodynamic change respond to     exercise with periodic breathing change. The investigators expect that these results obtained     from this study can aid in determining appropriate exercise intervention to improve aerobic     fitness as well as simultaneously improve hemodynamic control in patients with HF. A     quasi-experimental design will be used in this investigation. 60 HF patients will be     recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided     informed consent. These subjects will be divided into PB (n=30) and non-PB groups (n=30) by     their expression of CPET. Patients from each groups received the same therapy and trace     course for 2years including CV clinics, CPET and polysomnography. The investigators will     measure subjects' physical fitness, oxygen transport and utilization of exercising skeletal     muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and     aggregation, plasma biomarkers of myocardial damage, oxygen stress and quality of life at     pre-training stage and following the 6th , 12th, 18th, 24th months of the tracing program.     Experimental results were analyzed by descriptive statistics, independent t-test, and     repeated measure ANOVA. The investigators study the above parameter to realize the     physiological response to exercise of these patients and discover the appropriate exercise     intensity for prescription for EPB.   "
139852|NCT01454115|"     The primary objective is to assess the safety and tolerability of a single oral dose of     BMS-708163 in healthy young male subjects and in elderly male and female subjects.   "
139868|NCT01453907|"     This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to     65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study     will be randomized, double-blind and stratified by gender. Each cohort will contain 36     subjects (including at least four females), 30 who will receive ETI-204 and six who will     receive placebo.   "
139883|NCT01453712|"     The objective of this study is to compare a standard coronary CT angiography scan protocol     with conventional image reconstruction with a scan protocol using reduced tube current and a     new image reconstruction algorithm. The investigators hypothesize that the image quality of     the new scan protocol is not inferior, while radiation dose estimates are reduced by around     30%.      Secondary endpoints of the study include quantitative image quality parameters, prevalence of     non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics     (calcified, non-calcified, mixed) and prevalence of follow-up examinations.   "
139853|NCT01454102|"     There is no formal research hypothesis to be statistically tested in this protocol.        -  The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when          combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine;          Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects with NSCLC.        -  The study is evaluating the safety and tolerability of Nivolumab as maintenance therapy          in combination with Bevacizumab/Avastin that will be given after at least 4 cycles of          platinum doublet chemotherapy.        -  The study is evaluating the safety and tolerability of Nivolumab in combination with          Erlotinib among epidermal growth factor receptor (EGFR) mutation positive non-squamous          NSCLC subjects and as monotherapy in subjects with NSCLC.        -  The study is evaluating the safety and tolerability of Nivolumab in combination with          Ipilimumab in subjects with squamous and non-squamous NSCLC.        -  The study is evaluating the safety and tolerability of Nivolumab as switch maintenance          therapy in subjects with squamous and non-squamous NSCLC.        -  The study is evaluating the safety and tolerability of Nivolumab as monotherapy among          subjects with untreated, asymptomatic brain metastases and no evidence of cerebral          edema.   "
139854|NCT01454089|"     The primary objective of this study is to ascertain whether there is evidence of longer     survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control     Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to     control Arm.   "
139855|NCT01454076|"     This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB     designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative     bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug     interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in     patients with advanced nonhematologic malignancies or lymphoma.   "
139856|NCT01454063|"     The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug)     for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens     Replacement (ILR) surgery.   "
139857|NCT01454050|"     The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family.     Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which     automatically measures the RV/LV threshold and subsequently adjusts the pacing output.   "
139858|NCT01454037|"     The change of immune profiles and existence of circulating tumor cells following prostate     cryotherapy may be correlated with the clinical outcome.   "
139859|NCT01454024|"     This study is conducted in Asia. The aim of of this study is to evaluate the safety of     NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of     adverse events and technical complaints in patients with type 1 and type 2 diabetes in     routine clinical practice.   "
139860|NCT01454011|"     The study is designed to answer the following questions:        1. Is there any difference between the compositions of the HDL cholesterol subpopulations          of patients with hypogonadism and the healthy controls.        2. What is the effect of testosterone replacement therapy on the distributions of HDL          subgroups.        3. Is there any difference between the effects of the two different testosteron replacement          regiments   "
139861|NCT01453998|"     The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the     booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15     months of age, and the immune persistence following the primary series. All children in this     booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948     (NCT01248884). No new subjects will be enrolled in this booster study.   "
149134|NCT01332058|"     The investigators are conducting a pilot study for a clinical research trial to establish the     feasibility and acceptability of the intervention and the most effective recruitment     strategies prior to the full study.   "
139866|NCT01453933|"     Treatment with HIV-infection with protease inhibitors is associated with high blood lipids     and higher chance for cardiovascular complications. The RASSTER study aims to investigate the     effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel wall     function and inflammation,and activation of the immune system. we hypothesize that with this     intervention these parameters will improve. Since decreased vessel wall function and     inflammation are initial steps in the process of atherosclerosis, it is important to know     this data when treating HIV-infected patients.   "
139867|NCT01453920|"     The current norm in clinical practice for the treatment of choroidal neovascular membranes     (CNVM) secondary to Age-related Macular Degeneration(AMD) involves monthly injections of     Ranibizumab until the disease is stabilized. At this point, most physicians tend to follow     one of two treatment regimens. 'Treat -and-observe' entails regular follow-up of stable     patients, with treatment thereafter only in the presence of disease recurrence.     Alternatively, in a 'treat-and-extend' dosing strategy, intervals between treatments are     extended as long as disease remains stable. Many clinicians, who employ a treat-and-extend     dosing regimen, do not extend their treatment intervals beyond 3 months. However, it is     possible that the subgroup of patients on every three months 'treat-and-extend' dosing may     represent a uniquely, stable population that would perform particularly well on an     observational regimen with regular follow-up. We hypothesize that there will be a low CNVM     recurrence rate in wet AMD patients stable on every three months Ranibizumab dosing     ('treat-and-extend'), who begin a treat-and-observe protocol.   "
140547|NCT01444872|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and     pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal     dysfunction.   "
139869|NCT01453894|"     The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)     screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults,     beginning at age 50 and continuing until age 75. However, rates of CRC screening remain     inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening.     Screening rates are even lower among Black and Hispanic populations and in areas with higher     poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be     effective. Few studies have examined the rate of repeat FOBT testing; to the investigators     knowledge, none have been conducted in populations with high prevalence of barriers to     screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The     assumption that FOBT is an effective CRC screening strategy presumes it will be done at least     biennially, and cost-effectiveness studies of CRC screening strategies have found that the     results are sensitive to the rate of adherence. The investigators study will provide critical     information for providers and policymakers as they consider optimal strategies to increase     CRC screening among vulnerable populations.      Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal     occult blood testing (FOBT).      Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a     30-month period      Hypothesis 1: Compared to usual care, the intervention will increase the proportion of     patients who complete a repeat annual FOBT within 6 months of their due date.      Hypothesis 2: Compared to usual care, the intervention will increase the proportion of     patients who complete 2 additional FOBTs over the 30-month intervention period.      Aim 2: Explore perceived barriers to screening among patients who received the intervention     but did not complete repeat FOBT testing within 18 months      Aim 3: Assess the costs of the intervention and the costs per additional repeat screening     compared to patients who received usual care.   "
139870|NCT01453881|"     Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered     dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of     different types and sizes have also been developed for use in combination with pMDI. The     therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers     can optimize lung deposition as it obviates lung-hand coordination and retain larger     particles. The aim of this study is to compare the efficacy of the fine particle combination     pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a spacer in     patients without adequate asthma control on medium to high-dose inhaled steroids associated     with long acting beta adrenergic drugs. The hypothesis is that there is no clinical efficacy     difference between the two forms of drug administration.   "
139871|NCT01453868|"     Standing Balance, with and without blindfold, will be measured on patients with Multiple     Sclerosis using a Biodex Balance Scale.      A Twelve week intervention with one non impact aerobics group and one control group will be     performed.      Standing balance will then be retested on all subjects and the results will be statistically     compared.   "
139872|NCT01453855|"     The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy     of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or     ocular hypertension.   "
139873|NCT01453842|"     Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1     (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol     (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test     the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a     significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals     containing of olive oil or carbohydrates alone.   "
139874|NCT01453829|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients after Stroke and          clinical outcomes?   "
139875|NCT01453816|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients with Renal Failure          and clinical outcomes   "
139876|NCT01453803|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients with Parkinson's          Disease and clinical outcomes.   "
139877|NCT01453790|"     This project is an investigator-initiated, randomized-controlled trial of the effectiveness     of written and verbal parent-specific depression education and motivational advice in     increasing participants self-disclosed intention to seek follow-up care for possible     depression symptoms. The control condition is written and verbal general depression education     and advice. Hypothesis: the office-based experimental intervention of written and verbal     parent-specific depression and emotional health education and motivational advice increases     intention to seek follow-up services for emotional health or depression, when compared to     written and verbal general depression education and advice.   "
139878|NCT01453777|"     The intent of this clinical study is to answer the questions:        1. Is the proposed treatment safe        2. Is treatment effective in improving the disease pathology of patients with diffuse brain          lesions and clinical outcomes.   "
139882|NCT01453725|"     This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in     participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to     receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and     at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity     of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg     subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2,     the participants were to be told they were receiving active study drug. The primary     hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to     placebo as measured by the proportion of participants achieving an Assessment in Ankylosing     Spondylitis (ASAS) 20 response at Week 16.   "
139884|NCT01453699|"     The purpose of this study is to examine how the death of a parent as a child, adolescent or     young adult affects health and psychosocial wellbeing in adult life and to evaluate the     impact in adult life of counseling to children, adolescents and young adults who lost a     parent.   "
139885|NCT01453686|"     The use of topical steroids in the treatment of alopecia areata in children is common     practice. However, no particular potency of steroid is accepted as the standard treatment due     to the paucity of high quality evidence in the dermatology literature to substantiate their     use. Two randomized controlled trials exist assessing topical steroid efficacy in this     disorder, both have methodological limitations. The question remains as to which topical     steroid is safe and efficacious for use. We performed a double blinded controlled trial to     assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared     with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.   "
139886|NCT01452711|"     The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD),     compared to lansoprazole in patients with gastric ulcer.   "
139887|NCT01452698|"     The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared     to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA     classification grading system.   "
139888|NCT01452685|"     The purpose of this study is to compare the long term safety and efficacy of TAK-385, once     daily (QD) following continued administration in participants who completed a Phase II     dose-finding study.   "
139889|NCT01452672|"     This study compares two different field set-ups in patients with breast cancer following a     breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the     chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.      Patients in both treatment arms will receive radiotherapy with a shortened fractionation     schedule.      Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the     chest-wall and supraclavicular fossa in terms of loco-regional control, survival and     treatment toxicity.   "
139890|NCT01452659|"     The purpose of this study is to determine the efficacy and safety of TAK-385, once daily     (QD), for 12 weeks in women with uterine fibroids.   "
139892|NCT01452633|"     This study will help to answer the question, Does injecting local anesthetic before     laparoscopic instrument ports are placed decrease pain after surgery? Patients participating     will be randomly assigned to receive local anesthetic or saline injection at the site of a     laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24     hours the patient will be asked to rate their pain on a simple chart.   "
139893|NCT01452620|"     Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by     Interventional Cardiologists   "
139894|NCT01452607|"     A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in     healthy adults.   "
139895|NCT01452594|"     The drug diphenylcyclopropenone, or DPCP, modifies the immune system and has been shown to be     effective in treating certain kinds of cancer. This study hopes to improve our understanding     of how this drug helps create an effective immune response.   "
139896|NCT01452581|"     The purpose of this study is to evaluate the effects of transfusion of red blood cells in     treating postoperative dizziness in patients with moderate postoperative anemia after total     hip arthroplasty.   "
139897|NCT01452568|"     The optimal medical strategy for prevention of thromboembolic events after bioprosthetic     aorta valve replacement (BAVR) remains controversial.      The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against     aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or     without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate     thromboembolic complications, bleeding complications and death.   "
139898|NCT01452555|"     The purpose of the study is to determine if a Spanish-language HIV and HIV test information     video is as effective in delivering basic information regarding HIV and HIV tests to     primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test     counselor.   "
139899|NCT01452542|"     The primary objective of this pilot study is to determine the within-subject pharmacokinetic     (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat     administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed     commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to     plan and support the design of a subsequent bioequivalence study.   "
139900|NCT01452529|"     The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD     tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe     chronic low back pain uncontrolled by their current stable analgesic regimen   "
139901|NCT01452516|"     Spine fusion is one of the most common procedures performed in spinal surgery. Several     surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion     (PLF) is the most widely used. However, complications can develop when the bone graft     material used is insufficient to achieve the desired fusion. With its unique properties,     nanOss Bioactive can be mixed with bone marrow aspirate (BMA) and other graft materials to     obtain new bone growth during the healing process.      It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with     CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than     5 degrees of angular motion. In addition, patients are expected to see an improvement in     Oswestry Disability Index scores, VAS pain scores, and SF36 scores, while decreasing the use     of pain medication, returning to work, and finding satisfaction in the results of their     surgery.   "
139904|NCT01452477|"     Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese     medicine, this herb has been widely prescribed for several pathologies, including diabetes,     acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of     cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of     key molecules during both insulin signaling and androgen synthesis.The purpose of this study     is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary     Syndrome (PCOS) symptomatology.   "
139905|NCT01452464|"     The purpose of this US FDA post-marketing commitment study is to evaluate the safety of     MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance     Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The     pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies     and include certain neurological, immunological, vascular, musculoskeletal and hematologic     disorders. All events are collected retrospectively.   "
139906|NCT01452451|"     The purpose of this study is to investigate the safety and tolerability of repeated doses of     HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on     stable metformin monotherapy.   "
139907|NCT01452438|"     The purpose of this study is to summarize the occurrence of incident serious medically     attended events and events of interest up to 1 year following MenACWY-CRM vaccination     administered as part of routine clinical care. This US FDA post-marketing commitment study is     an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine     in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The     26 events of interest are events commonly evaluated in vaccine safety studies and include     certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All     events are collected retrospectively.   "
139908|NCT01452425|"     Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular     compartment pressures, and is a rare but serious postoperative complication.      The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and     non-invasively.      The objective is to develop a model mimicking the physiopathology of MCS to assess the     interest of the INVOS in this case.   "
139909|NCT01453673|"     This study is a retrospective review of chart. Clinical results including range of motion,     muscle power and scores will be recorded. Arthrocopic surgery of cruciate ligament and     meniscus will be re-evaluated for clinical application.   "
139910|NCT01453660|"     Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers,     including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are     side effects. One of the possible long-term side effects of cisplatin is thought to be heart     disease. The way that cisplatin causes heart disease is not well understood. One possibility     is that cisplatin may damage the inside layer of blood vessels called the endothelium. The     purpose of this study is to measure changes in the endothelium that happen when patients with     GCT get cisplatin chemotherapy and to compare these changes with a group of patients not     receiving chemotherapy.   "
139911|NCT01453647|"     This project will be the first known to explore the relationships among immunity and stress     and the symptoms of fatigue, pain, and mood following guided imagery in women with     fibromyalgia. Finding ways to reduce these unpleasant symptoms may lead to improved function     and well-being in this chronic disorder.   "
139912|NCT01453634|"     Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol     Injection.   "
139913|NCT01453621|"     Blunt head trauma (BHT) accounts for >450,000 emergency department (ED) visits for children     annually in the US. Fortunately, >95% of head trauma in children is minor in nature. Although     most children have minor head trauma, clinicians obtain cranial CTs in 35-50% of these     children, which carries a radiation risk of malignancy. Recently, the investigators conducted     a study of 44,000 children in the Pediatric Emergency Care Applied Research Network (PECARN)     in which the investigators developed and validated clinical prediction rules that identify     which children with minor BHT are at very low risk of having clinically-important traumatic     brain injuries (TBI) and, therefore, do not require a CT scan. In this proposal, the     investigators aim to assess whether implementing the PECARN TBI prediction rules (one for     preverbal, one for verbal children) via computerized clinical decision support (CDS)     decreases the number of (unnecessary) cranial CT scans obtained by ED physicians for children     with minor BHT at very low risk of clinically-important TBIs. After a two-site pilot phase to     test and refine the CDS, the investigators will conduct a seven-center prospective trial. The     investigators will measure cranial CT use prior to and after the intervention implementation     of CDS and clinician education. The investigators will study the use of CT by practitioners     for children <18 years for 12 months pre- and post-intervention.   "
139914|NCT01453608|"     The purpose of this study is to determine, relative to placebo, the effect of iron repletion     therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with     chronic heart failure and iron deficiency.   "
139915|NCT01453595|"     This study tests a new medication for treatment of kidney cancer, called BEZ235. This     medication works by blocking several mechanisms that the cancer needs to grow and survive. By     blocking these mechanisms, the medication can thus suppress further growth of the cancer,     possibly kill cancer cells. Older kidney cancer medications (such as temsirolimus [Torisel®]     or everolimus [Afinitor®]) typically only block one mechanism in cancer cells, so the     investigators think that BEZ235 may work even better against kidney cancer.      The purpose of the first part of this study is to test the safety of giving BEZ235 at     different doses. The investigators are trying to find a safe dose of BEZ235 and want to find     out what effects, good and/or bad, it has on the patient and the cancer.   "
139916|NCT01453582|"     The purpose of this study is to confirm the efficacy and safety of total flavonoids of     propolis dropping pill to treat angina pectoris, evaluated by total exercise time of     treadmill exercise test.   "
139917|NCT01453569|"     The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is     effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine     the best therapeutic dose of sodium oligo-mannurarate capsule.   "
139918|NCT01453556|"     Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in     laparoscopic right colectomy reduces post-operative bowel canalisation time and length of     stay in comparison with extracorporeal mechanical anastomosis.   "
139940|NCT01453270|"     The purpose of this study is to determine whether the use of a 3-hour protocol utilizing     non-invasive hemodynamic optimization treatment strategy results in better outcome and lower     hospital costs in patients who present with severe bloodstream infections to the Emergency     Department (ED).   "
140548|NCT01444859|"     Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev     Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent     gastrointestinal symptoms.   "
139919|NCT01453543|"     Background: There is a hypothesis in literature that the mechanical action of deep transverse     friction massage (DTF) produces vasodilatation and increases blood flow. But as yet, no     experimental study has confirmed the effect of DTF on blood flow in the Achilles tendon.     Objective: The purpose of the present study was to investigate whether one session of DTF can     influence the Achilles tendon blood flow.      Design: a randomized pre- posttest trial was set up. Patients: Sixty-two healthy participants     volunteered. Each person underwent the following four steps of the procedure: 1. Measuring     the tendon blood flow (PRE), 2.fifteen minutes of DTF on the Achilles tendon, 3. Measuring of     the tendon blood flow (POST), 4.follow - up measurement after 20 minutes of rest (POST20).      Intervention: one leg of each person was randomly assigned to deep transverse friction     session, the other leg was used as a control leg. Friction was applied continuously for a     total of 15 minutes. Measurements: the microcirculation was determined at 2 and 8 tissue     depths at the distal and the proximal midportion of the Achilles tendon. For each level, the     capillary blood flow, the tissue oxygen saturation, and the postcapillary venous filling     pressure was registered.   "
139920|NCT01453530|"     Rationale: Recovery from outpatient anesthesia includes dissipation of anesthetics agents,     normalization of physiological function, observation for medical or surgical complications,     treatment of immediate side effects of anesthesia and surgery and, ultimately, discharge and     return home. Street fitness implies that the patient is not only ready to go home, but is     also capable of safely taking part in the traffic. A full recovery of cognitive functions is     part of this stage. Neuromuscular blocking agents (NMBAs) are commonly used during surgery to     facilitate endotracheal intubation, allow assisted or controlled ventilation, and let surgery     proceed easily. Sugammadex is approved in Europe for routine clinical use to reverse     neuromuscular blockade induced by steroidal non-depolarizing muscle relaxants. Several     anesthesiologists from all over the world, have independently reported that patients seem to     be more alert in the early phase of recovery after reversal of NMB with sugammadex compared     to reversal with a cholinesterase inhibitor or spontaneous recovery. However, these     observations have not been substantiated in a clinical study.      Objective: The main aim of the present study is to assess whether sugammadex has a positive     effect on the post-operative alertness of the patients, to assess the nature, magnitude and     the time of onset of this effect and if a clinically relevant effect has been observed to     enable the sample size calculation for a formal well-powered efficacy study.      Study design: Randomized, controlled observer-blind single centre phase IV study. Upon After     stratification for type of surgery and age patients will be randomized to receive sugammadex     (arm A), neostigmine/glycopyrrolate (Arm B) or no reversal agent (arm C).      Study population: A total of 30 evaluable subjects, aged 18-65 years, with a medical need for     general anesthesia and neuromuscular blockade, will be included in the study.      Intervention: Anesthesia will be standardized according to the usual protocol. At the end of     the surgery when TOF ratio is ~0,9, and approximately 70-80% of nicotine receptors are still     blocked by rocuronium, patients will receive either sugammadex, neostigmine plus     glycopyrrolate, or no reversal agent.      Main study parameters: At 30, 60, and 120 minutes after the TOF ratio of ~0,9 has been     reached, the following commonly used, and non-invasive cognitive evaluations/scoring lists     will be carried out in a subsequent order to assess recovery and psychomotor function:     Modified Aldrete Score, the trail making test, the Maddox wing test, and visual analogue     scales from both observer and patient.   "
139921|NCT01453517|"     The study is designed to test a pilot intervention for bariatric patients who are starting to     regain weight after the 1st year post-surgery. Dialectical Behavior Therapy (DBT), an     empirically supported therapy for Borderline Personality Disorder, has also successfully been     applied to patients with substance use and binge eating problems. The purpose of this study     is to develop and test a group intervention based on DBT and cognitive behavioral therapy     (CBT) techniques for patients engaging in these maladaptive behaviors after surgery with     co-occuring weight gain.   "
139922|NCT01453504|"     The purpose of this trial is        1. to determine the recommended dose of everolimus for a subsequent Phase II trial        2. to determine the efficacy of everolimus plus DHAP   "
139923|NCT01453491|"     The purpose of this research study is to:        -  1) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects          with ulcerative colitis        -  2) Determine the amount of SRT2104 measured from a single blood sample in addition to          colon and/or rectal tissue samples (biopsies)        -  3) Determine whether SRT2104 has any anti-inflammatory effect on the colon and/or rectum          when taken orally for 8 weeks        -  4) Determine whether SRT2104 causes any detectable changes to specific biomarkers. A          biomarker is a biological marker (or substance such as a protein) that is used as an          indicator of changes in a biological state that corresponds to the risk or progression          of a disease.   "
139924|NCT01453478|"     This is a Phase I study to assess the combined effects of food and suppression of gastric     acid secretion on the relative bioavailability of an immediate release (IR) tablet     formulation and prototype bioenhanced formulations of GSK1325756, an oral interleukin 8     receptor (IL8R also known as CXCR2) antagonist. The objectives are to understand if the     co-administration of food enhances absorption and the inter-subject variability for the     current GSK1325756 IR tablet under fed state proton pump inhibitor (PPI) conditions and     secondly to assess whether two proposed bioenhanced formulations offer any improvement over     the current GSK1325756 IR formulation under PPI conditions.      This open-label, randomized, 5-period crossover study will be completed in a single cohort of     subjects, with an interim analysis after completion of Treatment Period 4. During Treatment     Periods 1 to 4, subjects will be randomized to receive GSK1325756 50 mg IR in the fed state,     GSK1325756 50 mg IR in the fasted state, GSK1325756 Bioenhanced Formulation 1 in the fasted     state, and GSK1325756 Bioenhanced Formulation 2 in the fasted state. Progression to Treatment     Period 5 and the choice of bioenhanced formulation for dosing in this treatment period will     be dependent on the findings of an interim analysis of the pharmacokinetic profile and     relative bioavailability of each formulation following completion of Treatment Periods 1 to     4. In Treatment Period 5, subjects will receive the selected GSK1325756 bioenhanced     formulation in the fed state.   "
139925|NCT01453465|"     RATIONALE: Studying biomarkers of tissue samples from patients with cancer in the laboratory     may help doctors learn more about changes the occur in DNA and identify biomarkers related to     cancer.      PURPOSE: This research trial studies biomarkers in samples from patients with rhabdoid tumor     of the kidney and atypical teratoid rhabdoid tumor.   "
140639|NCT01443676|"     The purpose of this study is to explore the efficacy of bevacizumab combined with     radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed     glioblastoma in the elderly.        -  Trial with medicinal product   "
139926|NCT01453452|"     RATIONALE: Physical activity, diet, and counseling may help breast and colorectal cancer     survivors to lose weight and improve their quality of life.      PURPOSE: This phase II trial studies how well exercise, diet, and counseling work in     improving physical activity and weight loss in overweight women who are breast and colorectal     cancer survivors.   "
139953|NCT01453101|"     The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and     bortezomib improves the progression free survival and the response rate compared to     historical controls of fludarabine and melphalan alone.   "
139954|NCT01453088|"     In this study the investigators are comparing this standard regimen to the newly established     regimen of melphalan and bortezomib.   "
139927|NCT01453439|"     The purpose of this study is to learn more about two different types of psychotherapy to help     individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic, and     common disorder consisting of distressing or impairing preoccupation with perceived defects     in one's physical appearance. Individuals with BDD have very poor psychosocial functioning     and high rates of hospitalization and suicidality. Because BDD differs in important ways from     other disorders, psychotherapies for other disorders are not adequate for BDD. Despite BDD's     severity, there is no adequately tested psychosocial treatment (psychotherapy) of any type     for this disorder. This study will compare the effectiveness of Cognitive Behavioral Therapy     and Supportive Psychotherapy as well as predictors of improvement.   "
139928|NCT01453426|"     This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of     two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and     Caucasian healthy volunteers.   "
139929|NCT01453413|"     The purpose of this study is to determine the difference between self-reported, estimated     blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.   "
139930|NCT01453400|"     This study is to evaluate the onset of relief provided by a single, oral dose of fast release     aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat     pain.   "
139931|NCT01453387|"     The main purpose of this study is to test the experimental drug, MSC2015103B at different     dose levels and on different treatment schedules, to see whether it is safe and can be     tolerated when given to subjects once a day one day per week over a 21-day period or once a     day three times per week over a 21-day period. The investigators would also like to find out     how MSC2015103B is broken down by the body.      Additional purposes of the trial are to assess side effects of MSC2015103B and to find out     whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to     explore pharmacokinetics.   "
139932|NCT01453374|"     This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison     and continuing VIVITROL upon release into the community.   "
139933|NCT01453361|"     Preliminary studies with a variety of vaccines suggest target accessibility (potential     immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to     overcome limitations of immunostimulatory cancer vaccines, the investigators have designed a     novel autologous vaccine to address inability to fully identify cancer associated antigens,     antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and     cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer     vaccines, the investigators designed a novel dual-modulatory autologous whole cell vaccine,     Vigil™ (bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine), incorporating the rhGMCSF     (recombinant human GMCSF) transgene and the bifunctional shRNAfurin (to block proprotein     conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer     associated antigens, 2) effect antigen recognition by the immune system (i.e. antigen to     immunogen), 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune     resistance. The investigators have also completed the Phase I assessment of Vigil™ vaccine in     27 advanced solid tumor patients (1.0 x 10e7 or 2.5 x 10e7 cells/injection/month for a     maximum of 12 vaccinations) who have not experienced any significant adverse effects     following 131 vaccinations, including 4 patients with melanoma. Plasmid functionality, immune     biomarker response, and preliminary evidence of anticancer activity have been observed. This     is a Phase II study of intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7     cells/injection; maximum of 12 vaccinations) in patients with stages IIIc and IV melanoma     with biopsy accessible lesions to document blood and intratumoral immune responses and assess     correlation with survival.   "
139934|NCT01453348|"     This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine     given alone or concomitantly with MenACWY-CRM to healthy adults.   "
139935|NCT01453335|"     VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter     access targets perceived by clinicians with experience in intravenous cannulation when     compared to the number of access targets that these clinicians are able to visualize unaided     or to palpate.   "
139936|NCT01453322|"     The objective of this study is to confirm and document that with the use of a FDA Class I     exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for     healthy adult volunteers with varying skin types to assist in the improved visualization, it     is possible to film, analyze and document PIV localized complications and venous flow and     refill.   "
139937|NCT01453309|"     The purpose of this study is to determine the cost-effectiveness of using a cell saver for 2     to 3 level lumbar fusions. A secondary objective is to determine if there will be a decrease     in the number of allogenic blood transfusions when a cell saver is used intraoperatively.     Another secondary objective is to determine incidence of complications associated with cell     saver use and transfusions.   "
139938|NCT01453296|"     This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444,     an orally inhaled long-acting agonist of the β2-adrenoceptor.   "
139962|NCT01452984|"     Mohs surgery excises non-melanoma skin cancer tumors of the head and neck while preserving     maximum healthy tissue, an advantageous characteristic when dealing with the cosmetic and     functional cervifacial region. Yet, treatment can result in changes to function and     appearance with effects on quality of life. This project uses Grounded Theory to explore the     Mohs surgery experience of NMSC patients who have head and neck lesions through interview and     observation of the surgical appointment.   "
139939|NCT01453283|"     Background:        -  Trabectedin is an experimental drug that kills some cancer cells in the laboratory and          in mice by interfering with genetic material (DNA) in cancer cells.        -  In some adult patients with cancer who received trabectedin, tumors grew slower or          shrank.      Objectives:        -  To determine a dose of trabectedin that can be given safely to children and adolescents          as a 24-hour continuous infusion through a vein.        -  To determine the side effects of trabectedin in children and adolescents.        -  To study how the body handles trabectedin by measuring the amount of the drug in the          bloodstream over time after a dose is given.        -  To measure the effect of trabectedin on DNA in white blood cells.        -  To determine if an individual's tumor cells have a specific proteins involved in DNA          repair and if a pattern of genes can be identified in tumor samples that might help          explain why trabectedin reduces tumors in some individuals and not others.        -  To study genetic factors that may influence the way the body handles trabectedin.        -  To see if trabectedin is beneficial in certain types of cancer.      Eligibility:      -Children between 4 year and 17 years of age with tumors that recur or no longer respond to     standard treatment.      Design:        -  Patients receive trabectedin as a 24-hour continuous infusion repeated every 21 days.          The first three children entering the study receive a dose of 1.1 mg/m2. Subsequent          groups of up to six patients receive higher doses (1.5 mg/m2 and 1.7 mg/m2) as long as          the preceding dose is well tolerated. Patients enrolled at the lowest dose level may          have their dose increased to the next level if they tolerated the lower dose well.          Treatment may continue as long as the cancer does not worsen and the treatment is          tolerated.        -  Patients have blood drawn on days 1, 2, 3, 4, 5 and 7 of the first treatment cycle to          study how the body handles trabectedin.        -  A tumor sample obtained from a prior surgery or biopsy is examined for proteins involved          in DNA repair.        -  A blood sample is drawn to look for genetic factors that may influence how the body          handles trabectedin.        -  Patients have periodic physical examinations and blood tests. MRI or CT scans are done          before starting therapy and after every two treatment cycles to evaluate the tumor.   "
139941|NCT01453257|"     Treatment options for patients with colorectal cancer (CRC) have increased in the last years.     However, there are no validated prospective molecular markers in CRC to select which agents     are better to treat any individual case. The conventional first-line treatment in CRC     patients in clinical studies get a proportion of patients free of progression at 12 months     ranging from 35-40% with a median of 9 months of free disease progression.      The aim of this study is to demonstrate that the identification of therapeutic targets in     real time and their prospectively use to customize the treatment get a proportion of     colorectal metastatic patients patients free of progression disease at 12 months of 50%.   "
139942|NCT01453244|"     The aim of this study is to investigate the relationships between drug response and the host     genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV).     And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean     patients with HCV.   "
139943|NCT01453231|"     Obesity is a chronic disease now considered a major public health concern in the global     context, as it causes or exacerbates many diseases limitations in providing quality of life     and higher treatment costs. The increase in the number of patients undergoing bariatric     surgery and the excess skin and subcutaneous tissue adjacent to slimming collaborate in the     search for growth by plastic surgery. Currently several techniques of thighplasty has been     submitted but no studies were found that evaluated the characteristic clinical and emotional     resulting from this procedure. This study has as a goal to evaluate the body image and     quality of life in women submitted to thighplasty.   "
139944|NCT01453218|"     Renal dysfunction in the context of liver transplantation is a major issue, with difficult     patients' management and determining a worsened prognosis.      Physiopathologically pretransplant renal dysfunction is dependent on multifactorial causes,     including hypoperfusion-derived functional renal insufficiency, hepatorenal syndrome or     interstitial parenchymatous insufficiency. On top, intra- or post-transplant events,     including hypoperfusion or calcineurin inhibitors nephrotoxicity may aggravate this     situation.      At present MELD criteria favours allocation of organs to patients suffering from renal     insufficiency, so at least 30% of the investigators liver transplant patients suffer from     some degree of renal impairment pretransplant.      After liver transplant impaired renal function tends to recover partially or completely,     unless advanced parenchymatous lesions are significantly involved as a major cause of renal     dysfunction.      In this context, calcineurin inhibitors avoiding or sparing protocols may help in the     recovery from renal insufficiency, improving long-term prognosis. The use of anti-CD25     antibodies is a good option, but provides a limited antirejection prophylaxis, limiting the     use of these antibodies to a reduced cohort of liver transplant patients.      Polyclonal antibodies might provide an advantage in management of liver transplant patients     with renal insufficiency, without increasing acute rejection episodes of the allograft     efficacy and security evaluation of low nephrotoxicity immunosuppression, based on the use of     ATeGe, in liver transplant candidates with pre-transplant renal dysfunction.      The aim of this study is to evaluate the efficacy and security use of immunosuppression based     on ATeGe in liver transplant recipients with pre-transplant renal dysfunction.   "
139945|NCT01453205|"     The overall purpose of the study is to determine if MEDI-551, when used in combination with     salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine     (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem     Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.   "
139946|NCT01453192|"     The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months     after transplantation in HIV-infected patients under three antiretroviral drugs regimen     including Raltegravir.   "
139947|NCT01453179|"     This clinical trial serves the purpose to compare the long-term effects of a treatment of     actinic keratosis - your skin disorder - using Aldara® 5% cream (Imiquimod) or Solaraze® 3%     gel (Diclofenac) on the face or the scalp. In particular, it should be found out whether the     healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can     be maintained for a prolonged period.   "
139948|NCT01453166|"     The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective     diet plan to reduce cardiovascular risk factors of new cardiovascular events.   "
139949|NCT01453153|"     Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and     tolerability study to determine the safe dose of PEGPH20 to use in combination with     gemcitabine in Stage IV previously untreated pancreatic cancer patients.      Phase 2: Randomized, double blind study to compare the effect of overall survival of     gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated     pancreatic cancer patients.   "
139992|NCT01452295|"     VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five     years after their completion of study participation in protocol VTI-206 (NCT00973817) to     gather information relating to the incidence of liver transplant, the incidence and type of     cancer (if any), and survival.   "
142232|NCT01422772|"     The purpose of this study is to evaluate the safety of VM202RY direct injection into the     cardiac muscles of the coronary artery territory where complete revascularization could not     be done even through Coronary Artery Bypass Graft.   "
139950|NCT01453140|"     In this study the investigators are proposing to treat patients with steroid-refractory     Graft-versus-host Disease (GVHD) in a manner designed to promote CD4+CD25+FoxP3+ Tregs. The     profound immune suppression which follows the most common salvage treatment for GVHD have     unfortunately lead to very poor outcomes because of high infection rates. A more targeted     approach based on the promotion and stabilization of Tregs is hoped to allow GVHD control     without the profound immunosuppression usually seen. High-dose cyclophosphamide and sirolimus     have been successfully used for the prevention of GVHD and have shown to enhance the Tregs     subpopulation. The addition of low dose IL-2 and a demethylating agent such as azacitidine     will also be studied in an attempt to promote and stabilize the FoxP3 expression of Tregs.   "
139951|NCT01453127|"     The investigators propose using DaTscan in patients with REM sleep behavior disorder (RBD),     mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB),     Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test     several hypotheses - some confirmatory, and some novel. Such use will provide new data on the     potential clinical and research utility of DaTscan in neurodegenerative diseases. The     findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging     studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of     neurodegenerative diseases.   "
139952|NCT01453114|"     The overarching goal of this study is to adapt a cognitive behavioral prevention of     recurrence treatment (CBT-PR) for women with a history of recurrent major depressive disorder     who decide to discontinue their maintenance anti-depressant (AD) treatment for pregnancy.   "
139955|NCT01453075|"     The purpose of this study is to study the effects of valacyclovir on patients who have     hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which     causes genital herpes. Some persons with genital herpes have sores in their private areas but     most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly     used to treat or prevent outbreaks of genital herpes. This medication is already approved by     the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved     to treat chronic hepatitis C.      The study will take 16 weeks. Participants will be assigned to take either the study drug,     valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the     persons participating will not know which medication they are receiving. Study visits will     occur every two weeks and will take approximately 3-45 minutes. All study visits will occur     at the G.V. Sonny Montgomery VA Medical Center.   "
139956|NCT01453062|"     B-cell chronic lymphocytic leukemia (CLL) is a subtype of mature peripheral B-cell neoplasms,     characterized by the accumulation of circulating malignant lymphocytes that typically express     cell surface markers CD5, CD20, and CD23. It is the most common type of leukemia in adults in     Western Europe and in the US. The median age at diagnosis is 65-70 years, with a male to     female ratio of 2:1. Initially, most patients present with asymptomatic lymphocytosis and do     not need cytoreductive therapy. Patients with active disease are characterized by a     lymphocyte doubling time of less than 6 months, or progressive, even massive lymphadenopathy,     hepatosplenomegaly, anemia and thrombocytopenia. Constitutional symptoms such as fever, night     sweats, unintended weight loss, and extreme fatigue are common in advanced disease and can     significantly impact quality of life. CLL also causes relative immunosuppression that     increases the risk of infections that are ultimately the major cause of death in this patient     population. Median survival at diagnosis ranges from 5 to 20+ years depending on risk     factors, but is only 6 to 14 months for patients with CLL refractory to available therapies.      Arzerra (ofatumumab) is a human monoclonal antibody (IgG1) that binds specifically to a     distinct epitope encompassing both the small and large extracellular loops of the CD20     molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from     the pre-B to mature B lymphocyte stage and on B-cell tumors.      Arzerra is designated as an orphan medicinal product in the European Union (EU) for treatment     of chronic lymphocytic leukemia. The Committee for Orphan Medicinal Products (COMP) concluded     that chronic lymphocytic leukemia was estimated to be affecting approximately 3.5 in 10,000     persons in the Community at the time the application was made (June 2008) and that the     condition is chronically debilitating and life-threatening, in particular due to poor     long-term survival in high-risk patients.      Arzerra was given a conditional approval in the EU on April 19, 2010. The approved indication     in the EU for the product is treatment of CLL in patients refractory to fludarabine and     alemtuzumab. A specific obligation for this conditional approval was an agreement by GSK to     conduct a post-marketing observational study in CLL patients receiving Arzerra. The data from     this study is intended to enhance the evidence of the safety and efficacy of Arzerra as it is     used in clinical practice, and once final data are available, together with results of a     second specific obligation study, will support the transition from conditional to a full     approval of Arzerra in the EU.      The objective of this observational study is to provide additional data to confirm the safety     profile and efficacy of Arzerra for CLL patients treated in clinical practice.      Particular data of interest are: co-morbidities (specific chronic disease diagnoses),     concomitant medications, disease (CLL) characteristics, prior treatment regimens, adverse     events, reasons for discontinuation of Arzerra therapy, Arzerra response, progression free     survival, and overall survival.      This is an observational, non-interventional, medical record review study in CLL patients. A     total of 100 patients with CLL who have previously received Arzerra, whether alive or     deceased, and have either completed the full course of Arzerra therapy or discontinued     treatment early will be eligible to participate in the study. Centers across Europe who are     members and non members of the European Research Initiative of CLL (ERIC) and treat CLL     patients will participate in the study.      CLL patients newly initiating Arzerra who are still undergoing the treatment phase and     patients having been treated with Arzerra in phase II or phase III clinical trials will be     excluded.      For patients who have completed approximately 1 year or more of follow up since Arzerra     initiation, data on response to Arzerra, adverse events during treatment and subsequent to     treatment, patient status, progression free survival and overall survival covering the period     up to approximately one-year post-drug initiation will be collected. For patients who have     not completed approximately l year of follow-up since Arzerra initiation, including those who     have been lost to follow up or died prior to one year or have not yet had a full year to     elapse in calendar time, similar data will be collected at the point in time at the last     available patient contact with the physician using information in the record. After approach     for informed consent from the patient or next of kin for patients who have died to review the     medical record, no interaction with the patient will occur.   "
139957|NCT01453049|"     The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose     combination tablet will safely and effectively control glycemia as first-line oral therapy in     drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of     treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary     objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in     lowering Glycosylated Hemoglobin (HbA1c).   "
139958|NCT01453036|"     1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin          is one of the main causes of failure of eradication. 23S rRNA point mutation of          Helicobacter pylori is associated clarithromycin resistance        2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment          regimens containing a proton pump inhibitor and combination of two antibiotics          (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate          Helicoabacter pylori more successfully        3. Material & methods The investigators enroll patients diagnosed with peptic ulcer,          endoscopically. Helicobacter pylori is documented with Urea breath test or silver          staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S          rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation,          the investigators consider as resistance to clarithromycin and choose the treatment          regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no          mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin,          clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare          eradication rate with conventional treatment,proton pump inhibitor, amoxicillin,          clarithromycin.   "
139959|NCT01453023|"     This study will investigate the safety and tolerability, pharmacokinetics, and     pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the     novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.   "
139960|NCT01453010|"     Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors     and causes huge loss of function and independence. A wide range of treatment approaches have     been developed to improve motor recovery. Despite treatments, such as Constraint Induced     Movement Therapy, showing promise, these in large have been have focused on high-intensity     and repetitive task-specific practice. Patients with little hand or finger movements however     may not be able to participate actively in task specific training.      The SaeboFlex is a dynamic orthosis, with a spring-loaded feature that facilitates opening of     the fingers and hand. This allows the patient to grasp and release objects repeatedly, hence     enabling participation in repetitive task practice and increasing potential for motor     recovery. Despite the SaeboFlex being used successfully in several centers in the country and     internationally, research to provide evidence of effectiveness is scarce. As a consequence     funding for the SaeboFlex is limited and usually requires patients' to fund their own.      The study aims to explore the potential benefits and feasibility of participating in a     Self-directed SaeboFlex training program to allow repetitive task practice in patients early     after stroke.      Subjects will undergo a 12-week training program comprising of a maximum of 3 x 45 minute     sessions a day. Activities focus on grasping and releasing balls and reaching for targets,     wearing the SaeboFlex for the majority of the session. At the end of each session the     SaeboFlex is removed and the hand is incorporated into functional tasks as able. Subjects     will be set individualized training program by a Saebo-trained therapist. The program will be     graded and progressed at a rate that is appropriate to each individual.      The study will measure and follow-up 8 subjects to explore improvements in recovery and     functional ability of the upper limb and affect on dependency levels. It will also explore     the level of intensity patients early after stroke can tolerate and how they participate in     self-directed therapy. All patients will meet the inclusion criteria and be motivated to     undergo the specific SaeboFlex self-directed training program. Subjects will record the time     and intensity of their training sessions and also their routine upper limb therapy. Patients     will be assessed before, during and after the 3 months training. If these cases show promise     the study will support the need for large trials including clinical efficacy and dose finding     studies.   "
139961|NCT01452997|"     The purpose of this study is to evaluate two separate antiinflammatory products for the     relief of symptoms through suppression of the immunological and inflammatory response     following a mosquito bite. The investigators have selected ibuprofen gel as a NSAI     formulation and 0.05% Clobetasone butyrate as a steroid cream with their appropriate physical     matched placebo products.   "
142233|NCT01422759|"     Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal     glands of girls with obesity and androgen excess   "
139963|NCT01452971|"     Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as     the major risk factors for lung cancer development. In this proposal, the investigators     collected fifteen kinds of major PAHs and the investigators would like to perform the     following studies:        1. Study the gene expression and subcellular localization of GNMT in the normal-tumor          tissue pairs of lung cancer patients.        2. Study the associations of the polymorphisms of GNMT in lung cancer patients and the          susceptibility to lung cancer;        3. To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the          normal-tumor tissue pairs of lung cancer patients.        4. Study the associations of the copy number variation (CNV) of GNMT and the susceptibility          to lung cancer;        5. Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung          cancer cell lines.   "
140026|NCT01451853|"     Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is     the objective of this study to determine the safety and efficacy of SPI-1005 at three dose     levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum     chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat     chemotherapy induced hearing loss and tinnitus.   "
139964|NCT01452958|"     Main objective :      The purpose of this study is to prove that the effects of bacterial endotoxin and cytokine     TNF-α, on protein loss, fatty acid release, and glucose metabolism depend on two mechanisms:        1. Direct local effects in muscle tissue.        2. Activation of the hypothalamo-pituitary axis and a stress-hormone response      Study protocols:        1. Acute metabolic effects of TNF-α(Beromun, Boehringer-Ingelheim Germany) vs placebo          perfused into the femoral artery of the leg in 8 healthy subjects.        2. Acute metabolic effects of             -  placebo(saline)             -  endotoxin(US standard reference E.Coli, endotoxin)             -  TNF-α(Beromun, Boehringer-Ingelheim Germany) given systemically             -  in 8 patients with hypopituitarism(to block stress hormone release) and in 8               healthy subjects all studied thrice.   "
139965|NCT01452945|"     Young children presenting to the Emergency Department (ED) with wheezing often have prolonged     stays in the ED or even get admitted to the hospital. This is a prospective observational     study in which the investigators will use bedside 2D ultrasound to evaluate the lung     ultrasound findings in children less than 24 months presenting to the ED with wheezing.      The investigators hypothesize that children less than 24 months presenting to the Emergency     Department with wheezing will have a range of lung ultrasound findings that will include     normal findings, B lines, subpleural consolidations, and pleural effusions. The investigators     also hypothesize that the findings will be reproducible between two equally trained     providers.      The investigators also hypothesize that lung ultrasound findings patients 0-24 months     presenting to the ED with wheezing will correlate with specific clinical outcomes. An     exploratory analysis will be performed to look for correlations between lung US findings and     acute severity, final diagnosis, presenting symptoms, prematurity, risk factors for atopy,     response to treatment and radiologic or viral studies if performed.   "
139966|NCT01452932|"     Objective: To estimate the effectiveness of muscle training, the degree of dyspnea and     aerobic capacity in patients over 50 with COPD, in a health care institution provider in     Antioquia.      Question: What is the effectiveness of muscle training, in the degree of dyspnea and aerobic     capacity in COPD patients over 50 years, in a health service institution provider in the     department of Antioquia?      Hypothesis: Muscle training causes changes in the degree of dyspnea and aerobic capacity,     other than the breathing exercises and relaxation      Design: Randomized clinical trial with allocation and blinding of the autcomes assesor.      Participants: COPD patients stage II and II, male and female, over 50 years old, who are     attending to a community health service provider in the department of Antioquia.      Intervention: A physiotherapeutic intervention using PNF technique was applied to the     experimental physiotherapy group versus Yoga sessions applied to the other group. Twelve     weeks protocol performing three sessions per week.      Outcome measures: Dyspnea degree and aerobic capacity was measured using the MMRC scale and     the six minute walking test respectively at the begining and the end of the study.   "
139967|NCT01452919|"     The purpose of this study is to determine whether or not people with schizophrenia who take     LY2140023 become physically dependent on it, and experience a series of symptoms such as     craving to have the drug when they stop using it.      This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a     double-blind phase consisting of up to 3 weeks.   "
139968|NCT01452906|"     The purpose of this study is to determine if Omeprazole is affected by PA21.   "
139969|NCT01452893|"     Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore,     patients who suffer from both, adrenal insufficiency and type I diabetes more frequently     report hypoglycemia, particularly after strenuous activities. The study investigates the     counter regulatory hormonal response to physical stress and the impact on cognitive function     in subjects with and without Addison's disease, type I diabetes and healthy subjects.   "
139970|NCT01452880|"     The purpose of this study is to compare the analgesic efficacy and side effects induced by     administration of two different infusion rates of remifentanil, 0,05 mcg/ Kg/ min versus     0,1mcg/ Kg/ min, in order to determine which one is the most appropriate analgesic treatment     to face extracorporeal shock wave lithotripsy.   "
139971|NCT01452867|"     Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and     maintaining an upper airway patent. Gaining evidence which ventilation technique may be most     efficient and safe is of utmost importance to potentially improve outcome during     cardiopulmonary resuscitation.   "
139972|NCT01452854|"     The purpose of this study is to look at how a chemotherapy treatment (Temozolomide, also     called Temodar) affects the process of ovarian aging which is measured by a decline in     ovarian follicle count, in patients with Low Grade Glioma (LGG). It is important to know if     different patient factors and Temozolomide influence the rate of ovarian aging in women with     LGG who have good long-term survival rates. This will allow better counseling about the     effects of this particular chemotherapy agent on fertility in women.   "
140160|NCT01450098|"     The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to     compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects     and first generation Japanese subjects after receiving a single oral dose of LY2484595 in a     fasted state, after eating a low-fat meal and after eating a high-fat meal.   "
139973|NCT01452841|"     Folklore has suggested that consuming grapefruit may promote weight control. Sparse data     exist to support this hypothesis, though there is some evidence of health promotional effects     regarding blood pressure and lipid profiles. The aims of this randomized controlled trial are     to determine the role of grapefruit in:        1. Reducing weight        2. Reducing blood pressure        3. Reducing inflammation        4. Improving the lipid profile.      The investigators hypothesize that six weeks of daily consumption of grapefruit will reduce     weight, blood pressure, and inflammation while improving the lipid profile in overweight,     healthy adults.   "
139974|NCT01452828|"     The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of     TR701 FA in subjects with advance renal impairment.   "
139975|NCT01452815|"     The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg     and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains     no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms     associated with gastroparesis.   "
139976|NCT01452802|"     The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II     (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class     IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who     meet the FDA approved indications for HM II LVAD destination therapy.   "
139977|NCT01452789|"     The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after     utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was     associated with a ~30% reduction length of treatment compared to standard of care morphine.     Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed     to unequivocally establish the superiority of buprenorphine over morphine. The primary     objective of the trial is to compare length of treatment using sublingual buprenorphine or     oral morphine solution in the pharmacologic treatment of the NAS.   "
139978|NCT01452776|"     The purpose of this study is to determine the safety of long term use of TAK-438, once daily     (QD), for the maintenance treatment of healed erosive esophagitis.   "
139979|NCT01452763|"     The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to     AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require     long-term therapy of low-dose aspirin.   "
139980|NCT01452750|"     The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared     to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require     long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).   "
139981|NCT01452737|"     The investigators wish to compare the efficacy and patient tolerability of a preparation     consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard     preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg     bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.   "
139982|NCT01452724|"     The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared     to lansoprazole in patients with duodenal ulcer.   "
139983|NCT01452412|"     Kidney disease is a common medical condition. Individuals with kidney disease develop a     build-up of acid in their blood. This acid can affect their muscles, bones, glucose     metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up,     in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones,     glucose metabolism and kidney.   "
139984|NCT01452399|"     This research study is designed to look at whether the routine use of shave margins (by     taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of     having positive surgical margins requiring another surgical procedure, and whether this     affects the long-term chances of getting cancer back in your breast.   "
139985|NCT01452386|"     To prove the modify functional magnetic stimulation could improve constipation.   "
139986|NCT01452373|"     The purpose of this Phase III trial is to evaluate the efficacy of oral administration of     dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor     modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.   "
139987|NCT01452360|"     This project expects the integrated database of terminally renal ill patients combines     clinical and files of Health Insurance and renal medical society database. It will provide     valuable actual evidence data to quality monitoring of dialysis treatment and related     academic research. Besides, using the cohort study of chronic renal disease --「epidemiologic     research of chronic renal disease」, we can trace the patient continually and analysis     different risk factors of chronic renal disease in Taiwan. Taken together, the results of     this project --1.1「Integrate the current database of renal disease and establishment of     national monitor system」and 1.2「Epidemiologic study in chronic renal disease」-- will provide     the basic rules of prevention and treatment, basic research and clinic application in chronic     renal disease.   "
139988|NCT01452347|"     To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical     heart valve.   "
139989|NCT01452334|"     The purpose of this study is to determine the side effects of treatment with the monoclonal     antibody anti-PD-L1 (BMS-936559) in subjects with compromised bone marrow function and the     dose that should be recommended for use in future studies.   "
139990|NCT01452321|"     Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a     strategic aid in the treatment of postpartum depression.      However, up to current days there have been no studies evaluating the effects of rTMS on     neurocognitive and social performance of women suffering from the disorder.      The present study evaluates the impacts of rTMS in clinical, cognitive and social     performance.   "
139991|NCT01452308|"     This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with     fibrosis of the liver.      Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of     10 participants who will receive simtuzumab every other week for a total of 3 infusions.     Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a     total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen     in Cohort 1.      Participants from both cohorts who have completed the main study will be allowed to continue     on simtuzumab treatment for an additional extension period, and will receive up to 13     additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.   "
140027|NCT01451840|"     This study is designed to compare the effects of alkalinized lidocaine in the endotracheal     tube cuff to a bolus dose of remifentanil given prior to the emergence of anesthesia:        -  on the incidence of perioperative coughing        -  on the time needed for the emergence of a desflurane-based anesthesia        -  on the incidence of sore throat after extubation.      The investigators hypothesis is that the use of alkalinized lidocaine in the endotracheal     tube cuff will reduce the incidence of perioperative coughing after a desflurane-based     anesthesia.   "
140028|NCT01451827|"     The purpose of this study is to compare the short-term effects of two tolvaptan formulations     in patients with ADPKD.   "
140049|NCT01451554|"     To date, no studies have been published assessing the effectiveness of portion control     interventions in a primary care setting. The investigators will conduct a pilot study to     assess the effectiveness of an intervention including a portion control plate and dietary     counseling for weight loss among obese patients in a general medicine primary care practice.   "
139993|NCT01452282|"     Introduction: Patients undergoing noncardiac surgery are at increased risk of cardiovascular     complications. The development of methods that can accurately predict the occurrence of these     events is of critical importance and large studies have been published with this purpose.     Based on these studies, several algorithms have been proposed to predict of cardiovascular     events postoperatively. However, quantification of this risk is often difficult to measure,     especially in those patients with subclinical disease, not always detected in routine     evaluation. The ankle brachial index (ABI) has proved a valuable tool in the quantification     of cardiovascular risk, and perhaps the most promising when compared with other methods. It     is easy, cheap, fast and feasible in office care, with a great acceptance between patients     and small intra and inter observer variability. Despite strong evidence of the utility of ABI     as a tool in assessing cardiovascular risk, there are no data about the use of ABI in other     patients referred for non vascular surgery, which constitutes the majority of operations     performed worldwide.      Objectives: To evaluate the use of ABI as a predictor of cardiovascular events in patients     undergoing non-cardiac and non-vascular surgery and its applicability as a tool in the     reclassification of patient risk groups established by guidelines for perioperative     evaluation.      Methods: 300 moderate to high risk patients referred for non-vascular and non-cardiac will be     included. Data about risk factors, signs and symptoms, physical examination and treatment     used will be collected before surgery. The ABI will be measured and the patient will be     monitored for 30 days to the detection of cardiovascular events: death from any     cardiovascular causes, unstable angina, nonfatal myocardial infarction, isolated elevation of     troponin, decompensated heart failure, cardiogenic shock, stop nonfatal heart failure,     pulmonary edema, stroke and lower limb ischemia. Postoperative electrocardiogram, total     creatine kinase, MB fraction and troponin I will be measured daily until 3º day and whenever     clinically indicated.   "
139994|NCT01452269|"     The purpose of the Deaf Weight Wise study is to test a 16 week, evidence-based, comprehensive     program to change obesity-related health behaviors in Deaf people who use American Sign     Language (ASL) as their primary language.      Participants will be randomized to one of two study arms - immediate intervention or delayed     intervention. In addition to the intervention activities, participants will also take part in     five study visits over the course of two years. At these study visits, the investigators will     administer several surveys as well as conduct biometric assessments.      The investigators primary hypothesis is that the immediate intervention group will increase     their levels of physical activity and reduce their caloric intake and body weight immediately     following the intervention, compared to the delayed intervention group.   "
139995|NCT01452256|"     Desflurane and its effect on postoperative morbidity and mortality in patients undergoing     thoracic surgery.      Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a     group of general anesthetics. Because of the hypnotic effects of these agents, attention has     mainly focused on the central nervous system. In the last 10 years, however, numerous studies     have reported that volatile anesthetic agents interact with membrane structures of the     myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural     abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced     preconditioning has become a main topic in cardiac research worldwide        -  Trial with medicinal product   "
139996|NCT01452243|"     The first objective is to determine the efficacy of calcium and vitamin D supplementation at     doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in     non-institutionalized elderly people.      The second objective is to measure and compare treatment groups (calcium and vitamin D vs     placebo) as regards muscle strength and musculoskeletal function, bone mineral density,     calcidiol level and treatment safety.   "
139997|NCT01452230|"     Introduction: According to studies, a low physical capacity before surgery is linked with     smaller weigh loss after surgery and increases risks of peri-surgical complications. Practice     of regular physical activity in obese individuals improves their physical capacity. No     specific recommendation on physical activity prescription is currently available for this     reduced fitness population. This project aims to evaluate if a Pre-Surgical Physical Activity     Training (PreSPAT) improves physical capacity, surgery effectiveness and decreases     peri-surgical complications in morbidly obese individuals.      Methods: This pilot project will be divided in 2 phases:      Phase 1: Ten candidates for bariatric surgery will be included in this phase. In a     pre-training focus group, subjects will be interviewed about their expectations and their     availability for a PreSPAT. These results combined with those of the literature will be used     to design the PreSPAT. To measure its effectiveness, anthropometric parameters, body     composition, physical capacity, motivational stage, perceived benefits and barriers facing     physical activity and quality of life will be evaluated before and after the PreSPAT.     Subjects satisfaction with the physical activity intervention will be measured with a     questionnaire at 6 weeks and at the end of the PreSPAT.      Phase 2: 50 candidates for bariatric surgery will be randomized in 2 groups:      Control group: receiving usual care from the integrated medical and surgical treatment     obesity clinic of the Centre Hospitalier Universitaire de Sherbrooke, which includes     individual counselling by an exercise physiologist every 6 weeks.      Intervention group: will attend for three months before surgery sessions of supervised     physical activity as developed during phase 1 in addition to usual care of the integrated     medical and surgical treatment obesity clinic.      Physical capacity, anthropometry, body composition, readiness to change, comorbidities,     perceived benefits and barriers of physical activity, usual practice of physical activity,     quality of life and patient satisfaction with physical activity intervention will be     evaluated in the two groups before and after intervention and every 3 months after the     surgery during one year. Each occurrence of peri-surgery complications, and the duration of     surgery and hospitalization will be recorded.      Impacts: Feasibility and effectiveness of supervised physical activity training will be     assessed before the beginning of the randomized controlled study. Phase 2 of the project may     generate information that will improve the management of obese candidates for bariatric     surgery in order to ensure optimal results for their health. This project will also allow a     better understanding of criteria leading to successful surgery and the effects of exercise     training in morbidly obese individuals.   "
139998|NCT01452217|"     Alterations in pancreatic blood have been implicated in pancreatic inflammation and pain.     Several modalities have been used to assess pancreatic blood flow although some of these     methods are invasive, use ionising radiation or intravenous contrast media. This is the first     study to utilise non-invasive magnetic resonance imaging to quantify flow within arteries     supplying the pancreas and pancreatic perfusion is response to secretin stimulation.   "
140006|NCT01452113|"     The purpose of this study is to compare the effect of a single administration of a DPP-IV     inhibitor (vildagliptin: Galvus ®) versus no treatment over two populations of diabetic     patients: without diabetic autonomic neuropathy (NA, i.e. the control group) and with     diabetic autonomic neuropathy (i.e. the neuropathy group). The investigators hypothesize that     the therapeutic efficacy of DPP-IV inhibitors is partly mediated by the autonomic nervous     system. This hypothesis will be validated if a lower glycemic response to DPP-IV inhibitor     treatment is observed for the neuropathy group compared to control.   "
139999|NCT01452204|"     In the past many authors have reported the abnormal contact between the rotator cuff and     coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives     of this study relate specifically to improve the symptoms and rehabilitation of shoulder     function of the patient:        1. Assess the effectiveness of magnet therapy in the treatment of impingement of the          rotator cuff;        2. Assess whether the application of magnetic therapy 3 times a week for three weeks, may          be effective as a single treatment of impingement of the rotator cuff;        3. Assess whether the combination of magnetic therapy with therapeutic exercises is more          effective than magnetic therapy only;        4. Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the          short and long term.        5. Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and          20 mT in patients with shoulder impingement syndrome.   "
140029|NCT01451814|"     The primary objective of this study is to test a manualized adaptation of positive     psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a     preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and     efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation     treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will     include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b     research will provide the foundation for a future application to conduct a large-scale, Stage     II, randomized clinical trial.   "
140000|NCT01452191|"     Many children have accidents, some are very serious and they are a major cause of death in     children aged 1-4 years. Many accidents are preventable This study aims to find out the best     way to help Children's Centres to provide home safety information about preventing fires to     parents and carers of young children.      36 Children's Centres in four study centres, Nottingham, Bristol, Norwich and Newcastle will     be recruited to the study. 30 families will be recruited from each Children's Centre.     Children's Centres serving the most deprived populations will be eligible to take part.      Families will be eligible to take part if they have attended a participating Children's     Centre in the previous three months, have parents who are 16 years or older, have a child     under three years old and live within the catchment area of that Children's Centre. When 30     families have been recruited that Centre will be allocated, at random, to one of three     groups. Children's Centres in group one will be provided with guidance about preventing     fire-related injuries (an Injury Prevention Briefing (IPB))and help and support to implement     the IPB, the second group will be sent the IPB and the third group will not be provided with     the IPB ('usual care'). Children's Centres will devise their own programmes of safety advice     for parents based on the IPB.      At recruitment and 12 months later, families and Children's Centres will complete     questionnaires about fire safety practices. Children's Centres will also complete a     paper-based tool about the implementation process at 12 months. Information about barriers     and facilitators to implementing the IPB will be collected through interviews with Children's     Centre staff.      The study will run from May 2011 to March 2014.   "
140001|NCT01452178|"     The main purposes of this study are:        -  to describe the prevalence of peripheral artery disease (including lower extremity          artery disease, carotid artery disease, renal artery disease, and abdominal aortic          disease) in patients with acute myocardial infarction in comparison to control subject          from the general population,        -  to evaluate the association of peripheral artery disease with glucometabolic status in          patients with acute myocardial infarction,        -  to assess the prevalence of type D personality in patients with acute myocardial          infarction com pared to control subjects from the general population,        -  to examine the prognostic value of peripheral artery disease in patients with acute          myocardial infartion, and        -  to evaluate the prognostic value of type D personality in patients with acute myocardial          infarction.   "
140002|NCT01452165|"     The main purposes of this study are:        -  to describe the prevalence and degree of reduced left ventricular function and          hypertrophy in patients with peripheral arterial disease in comparison to controls from          the general population,        -  to evaluate factors of importance to left ventricular dysfunction and hypertrophy in          patients with peripheral arterial disease, and        -  to assess the impact of cardiac function and left ventricular hypertrophy on long-term          prognosis in patients with peripheral artery disease.   "
140003|NCT01452152|"     It is standard treatment to take anti-platelet medication after cardiac catheterization and     stent placement to help prevent the formation of blood clots that may cause heart attack or     stroke. The most commonly used anti-platelet medicine is clopidogrel (Plavix®). However,     researchers have found that people vary in their response to clopidogrel, in part because of     differences in their genes. Prasugrel (Effient®)is another anti-platelet medication used to     prevent clots. The genetic differences that affect clopidogrel response do not affect     prasugrel response. Recently, the FDA added a warning to the label of clopidogrel to notify     doctors and patients with certain genetic differences may not get the full benefit from     clopidogrel. Despite this, genetic testing for these variations is not usually done in     standard medical practice. The purpose of this study is to see if patients with certain gene     differences have fewer major cardiac events after stent placement if they are given     anti-platelet therapy guided by their individual genetic type compared to standard     anti-platelet therapy.   "
140004|NCT01452139|"     The objective of the RAPID STEMI study is to evaluate the feasibility, efficacy, and safety     of a pharmacogenetic approach to anti-platelet therapy for the treatment of ST-segment     elevation myocardial infarction (STEMI) patients following percutaneous coronary intervention     (PCI) using point-of-care genetic testing for the CYP2C19*2, *17, and ABCB1 3435 C>T alleles.   "
140005|NCT01452126|"     This is a dose finding study to identify the minimum effective anesthetic concentration     (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in     supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and     popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane     (TAP) blocks in adults.   "
140022|NCT01451905|"     To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans     with no skin disease   "
140749|NCT01442207|"     The purpose of the study is to compare the role of cervical cerclage versus expectant     management in women with complete placenta previa (≥ 10mm over internal os) presenting with     shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.   "
140007|NCT01452100|"     Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring     in elderly with severe atherosclerosis.      In most patients, avoiding the precipitating factors and combination of statin and RAS     inhibitor are recommended.      The lack of randomized controlled trial in CCE precludes significant advances. The     investigators decided to assess whether prednisone started early, at mild dosage and for a     short period prevents death and progression to end-stage renal failure in patients with     severe CCE, as compared to placebo.   "
140008|NCT01452087|"     Compare the effects of single session of exercise vs. chronic exercise training on key risk     factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and     blood pressure) in overweight adults.   "
140044|NCT01451619|"     This study will assess the effect of MK-0524 relative to placebo, on signs and symptoms of     rosacea and to determine the safety and tolerability profile of MK-0524 in participants with     rosacea.   "
140045|NCT01451606|"     This study is examining the effectiveness of duloxetine as a treatment for chronic pelvic     pain in women. Duloxetine is FDA approved for the treatment of other pain conditions,     including fibromyalgia and diabetic neuropathy.   "
140009|NCT01452074|"     the investigators first aim is to determine the effect of low intensity exercise (without     weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these     processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days     without exercise in obese adults. the investigators second aim is to determine the effect of     combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle     lipid metabolism, and factors regulating these processes in skeletal muscle.      Although a single 40 minute session of exercise at a low exercise intensity will not improve     insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise     training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied     by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory     activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid     partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training     program (without weight-loss) will be similar to that measured after 2 weeks of training. the     investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and     pro-inflammatory activation will be markedly improved after 10% weight loss when measured the     day after exercise. the investigators would expect the improvements in Insulin sensitivity,     accumulation of fatty acid intermediates, and markers of inflammatory stress will be     significantly attenuated when measured 3 days after the most recent exercise session, but     beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared     with before weight loss.   "
140010|NCT01452061|"     There are three purposes to this study. The first purpose is to evaluate the value of a     genetic test in determining risk for autism spectrum disorder. Processing for genetic samples     will be completed at the Cleveland Clinic using research equipment provided by IntegraGen.     The second purpose is to identify genetic changes that may be associated with autism spectrum     disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether     genetic differences and changes may predict which individuals benefit from medicine used to     treat attention problems or other psychiatric difficulties.      Between 600-800 people are expected to participate in this study - approximately 300     individuals with an autism spectrum disorder, 75 individuals with attention     deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy     siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.      Study procedures will vary based upon the specific group participants are suspected to fall     into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental     delay, healthy sibling, or unrelated healthy control).        -  All individuals will be asked to participate in a cheek swab (gently swabbing the inside          of your cheek) to obtain cells used for genetic testing. Genetic material will be stored          with identifiers such as numbers, letters or codes.        -  Parents or caregivers will be asked to complete questionnaires that examine medical and          family history as well as current symptoms and quality of life for the participant.        -  Participants may undergo speech and language testing. This involves answering questions,          looking at pictures or identifying items.        -  Information recorded in participant medical records will be reviewed and collected for          this study.   "
140011|NCT01452048|"     The investigators specific aim is to compare the relationship between systemic fatty acid     availability and insulin sensitivity in a relatively homogenous population of obese adults.     The investigators anticipate 1) greater systemic fatty acid availability will be associated     with lower insulin sensitivity and 2) greater systemic fatty acid availability will be     associated with greater accumulation of fatty acid intermediates and pro-inflammatory     markers.   "
140012|NCT01452035|"     Many of the beneficial metabolic effects of endurance exercise training are not due to     adaptations to weeks, months, or even years of training, but rather much is due to the     response to the most recent exercise session(s). Therefore, the investigators contend that     lifestyle interventions for obese individuals should be tailored to optimize the metabolic     effects of the most recent exercise session(s). But the dose of exercise necessary to evoke     these beneficial responses is not known, and the mechanisms responsible for these     improvements are poorly understood. The findings from these studies will: 1) establish the     minimum dose of a single exercise session necessary to improve insulin sensitivity the next     day in obese adults, 2) characterize the underlying metabolic factors responsible for the     improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that     occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program.     Findings from these studies will provide valuable information for the development of     lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise     session in obese patients.   "
140013|NCT01452022|"     This is an open-label non-randomised, prospective, post market study to evaluate the     performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving     posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post     operation using x-rays and CT scans. Quality of life questionnaires also used to assess     clinical outcome measures such as pain and quality of life. Patients followed up for 24     months after surgery.   "
140014|NCT01452009|"     A multi-center, observer-masked, randomized, parallel group efficacy and safety study of     TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%   "
140015|NCT01451996|"     The primary goal of this study is to examine determinants of the efficacy of Claritin.   "
140061|NCT01451398|"     Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on     either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or     two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or     Technosphere Powder (placebo) added to their oral antidiabetic drugs.   "
140016|NCT01451983|"     The purpose of this research is to better understand the genetic, biochemical, cognitive and     behavioral symptom abnormalities that contribute to autism spectrum disorders. The     investigators anticipate recruiting at least 100 participants with autism spectrum disorder     and large head size, at least 100 participants with autism spectrum disorder without large     head size and at least 40 healthy siblings. Biological parents are expected to be recruited     only as genetic changes are identified in individuals with autism spectrum disorders to     better understand the nature of these genetic changes. Participants are asked to complete     cognitive testing, a blood draw, urine collection and measurement of his/her height, weight     and head circumference. Parents or caregivers may be asked to complete a diagnostic     evaluation and will complete questionnaires that examine the participant's medical and family     history as well as his/her current symptoms, functioning, and quality of life. A brief report     simply listing and giving a basic description of any behavioral diagnostic information,     autism symptoms, adaptive functioning, and a listing of results from cognitive testing will     be provided as part of this study.   "
140046|NCT01451593|"     Optic neuritis is caused by inflammation of the optic nerve and causes loss of vision in the     affected eye. It is often associated with multiple sclerosis. Loss of vision after an attack     of optic neuritis is caused by damage to the nerve fibres in the optic nerve. There are a     number of factors that contribute to nerve fibre damage including increased levels of sodium     within them, so blocking sodium entry could help to protect them against damage.      The purpose of this study is determine whether phenytoin (which blocks sodium entry into     cells) can protect against loss of nerve fibres and prevent loss of vision after optic     neuritis.   "
140017|NCT01451970|"     Individuals have a significant capacity to adapt to different environments by changing their     core metabolic pathways. This adaptation is especially important in regards to diet.     Epidemiological research over the last several decades have shown that diets high in     saturated fats have a greater ability to cause insulin resistance and the 'metabolic     syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the     risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as     compared to high carbohydrate or high saturated fat diets, result in increased insulin     sensitivity and improved lipid profiles.      In this application, the investigators propose to systematically assess the effects of two     diets enriched in either saturated or unsaturated fatty acids and determine the cellular and     molecular mechanisms of the apparent increase in insulin sensitivity. The investigators     hypothesize that individuals will 'adapt' to the different diets and the investigators will     be able to generate predictive alterations in gene expression and metabolites that underlie     the alterations in metabolism. In parallel, the investigators will test the ability of these     different diets to affect the release of gastrointestinal hormones that may be critical to     modulation of appetite.   "
140018|NCT01451957|"     Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible     for the improvements in metabolic health after a single session of endurance exercise. The     investigators will determine the effect of a single session of endurance exercise on     whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of     factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity     (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise,     effect insulin signalling and insulin sensitivity. Every effort will be made to recruit     subjects from ethnic and minority groups. Before participating in the study, subjects will be     informed of all the procedures and potential risks, and they will sign an informed consent     form approved by The University of Michigan Institutional Review Board. Eligible volunteers     will participate in three separate trials, in a randomized order. In two trials subjects will     eat exactly the same amount of calories, except in one trial they will exercise (eucaloric +     exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial     subjects will again remain sedentary but instead they will ingest appropriate calories to     maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also     able to investigate the effect of acute caloric perturbations on insulin sensitivity, because     it is possible that the enhanced insulin sensitivity evident after exercise, as compared to     the sedentary state, is due to caloric deficit and not the exercise bout, per se.   "
140019|NCT01451944|"     The objective of our program is to evaluate the effect of home health nurse intervention and     education on hospital admissions, ER utilization and asthma control of Passport asthma     patients. The investigators hypothesize that case management and in home education by nurses     will decrease hospitalizations and ER asthma visits and improves disease control in our     population.      Our clinic population consists of primarily inner-city, low income, medicaid recipients. This     population suffers from severe asthma much more than the typical pediatric population. Asthma     remains the most frequent cause of hospital admission for our patient population. Home health     nurse asthma education and home visits have been reported to reduce asthma triggers in the     home and improve asthma control. The unique partnership between the pediatrician and the home     health nurse will give us a better understanding of the health needs for this population,     will improve quality of care and deliver more cost effective care.   "
140020|NCT01451931|"     This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared     to computed tomography (CT) for the initial emergency room evaluation of patients with     suspected renal colic. The investigators will compare several measures of effectiveness     including morbidity related to the patient's underlying disease, or complications related to     delayed diagnosis, patient status regarding pain/missed days of work, and utilization of     health care resources based on one of three study arms: ultrasound in the Emergency     Department, ultrasound in Radiology or CT.   "
140021|NCT01451918|"     Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an     over-the-counter health supplement, has been shown to have a number of health benefits. Data     from in vitro and animal studies suggest that it has beneficial effects on insulin     sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic     studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein     metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting     the metabolic abnormalities of insulin resistant individuals the investigators plan to     examine the effects of resveratrol on intestinal and hepatic lipoprotein production in     humans.   "
140023|NCT01451892|"     Title:      The effect of dance-therapy on the functional capacity, body image and quality of life of     patients with advanced obesity      Project duration:      33 months (August 2010 to June 2013)      Clinical context:      Obesity has reached epidemic proportions. The gait and balance problems in obese people and     the associated decreased functional capacity and risk of falling highlight the need to     evaluate the benefits of specific treatments on these problems. Attention should be paid not     only to metabolic management but also to the physical rehabilitation required in cases of     advanced obesity.      Objectives:      The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity     (walking ability, postural control and physical activity level), body image and quality of     life of patients with advanced obesity.   "
140024|NCT01451879|"     Hypothesis: the effectiveness of treatment of Pompe Disease with rhGAA enzyme replacement     therapy (ERT) is limited at least in part because patients develop antibodies against the     provided rhGAA enzyme. Treatment with immunomodulatory drugs may dampen or eliminate the     anti-rhGAA immune response in patients receiving ERT, thereby allowing for greater ERT     efficacy. Studying the immune response to rhGAA may provide valuable insight into the role of     the immune system in the effectiveness of ERT for Pompe Disease.   "
140025|NCT01451866|"     A complex training on a dynamic leg-press with visual feed-back will improve coordinative     capacity, power, sensorimotor and cognitive aspects more than a classic training on the same     leg-press but without visual feed-back.   "
140030|NCT01451801|"     Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none     or to few antibodies after a standard immunization with 3 vaccines. These individuals are     defined as non-responders. The investigators wish to investigate if mounting another kind of     immune response, called the cellular immune (CMI) response, protects these non-responders.      Aim/Hypothesis      Primary aims:        1. To estimate the CMI response in serologic non-responders after receiving a standard          course of HBV immunization           Secondary aims:        2. To establish the prevalence of serological non-responders after a standard course of HBV          vaccination.        3. To assess the safety of the vaccine.        4. Evaluate predictors of serologic non-response in young, healthy individuals receiving a          standard course of HBV immunization        5. To compare the immunological profile before and after a standard HBV vaccination regimen          on non-responders and responders        6. Establish a rapid test for measuring CMI after being HBV vaccinated.      A total of 400 healthy volunteers receive a standard course of immunization with a combined     hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Blood is drawn at 0 and 8 months     from all participants. The blood will be analysed to see if there is antibodies or/and if     there is mounted a cellular immune response by measuring on parameters called cytokines.   "
140031|NCT01451788|"     The Finnish Paediatric Orthopaedic Study Group will perform a prospective randomized,     multicenter, clinical trial comparing Gelatin matrix with human derived thrombin (Floseal,     Baxter) and without use of Floseal in adolescents undergoing posterior spinal deformity     surgery for AIS (adolescent idiopathic scoliosis between 45 and 90 degrees) in Turku, Tampare     and Helsinki Children's Hospitals. Sixty patients will be randomized into the intervention     group receiving Floseal (n=30) and control group not receiving Floseal (n=30). Each     University Hospital will treat 10 Floseal and 10 conventional treated scoliosis patients     (block randomization). Both treatment groups will be allowed to use conventional blood saving     methods.   "
140032|NCT01451775|"     Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and     assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under     fasting conditions.   "
140033|NCT01451762|"     Pain after ambulatory surgery remains an unsolved problem in The United States and Europe. It     is associated with delayed hospital discharge and it can result to an increased opioid     consumption with adverse side effects. The concept of multimodal analgesic technique was     introduced more than 15 years ago and several techniques have been studied over the years     including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids,     ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal     nociceptors and C-fibers, producing pain which is further increased by neurogenically     mediated release of substance P from afferent pain fibers. Several non-selective or H1     -selective histamine receptors antagonists have been demonstrated in animal models and     clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing     properties without adverse sedative effects in patients undergoing abdominal hysterectomy.      Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing     postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative     pain and other important outcomes after ambulatory surgery such as time to meet discharge     criteria have not being studied.      The MQOR 40 is a validated instrument that was specifically design to evaluate patient     recovery after anesthesia and surgery. This instrument can be particularly valid to examine     interventions which affect different spheres of patient recovery as is the case of     diphenhydramine. The objective of this study is to determine a dose response effect of     preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery.     The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease     postoperative pain, opioid consumption and opioid related side effects after ambulatory     surgery.      The research question: Does a preoperative dose of diphenhydramine improve postoperative     quality of recovery after ambulatory surgery? The hypothesis of this study is that     preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and     vomiting (PONV), sleep which will translate in a better overall quality of recovery.   "
140034|NCT01451749|"     The purpose of this phase III study is to further evaluate the effects of shenwu capsule, a     traditional Chinese herbal medicine, on cognition, function and memory in patients with     amnestic mild cognitive impairment (MCI) who are at greater risk for developing Alzheimer's     disease, in a 6-month supervised protocol of a traditional Chinese herbal medicine. The     results of this study may provide support for a relatively simple and inexpensive treatment     strategy with herbal therapy that specifically targets individuals with the mild cognitive     impairment that directly influence risk of developing dementia for older adults.   "
140035|NCT01451736|"     This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting     injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode     schizophrenia.   "
140036|NCT01451723|"     The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple     Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate     (a chemical that reflects the number of neurons and their metabolism) over one year between     people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS     treated with a matching sugar pill.   "
140037|NCT01451710|"     This is a single center,prospective,no-controlled clinical trial   "
140062|NCT01451385|"     The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35     days use as evaluated with physical exam, vital signs, pulse oximetry, clinical laboratory     tests, and AEs.   "
140038|NCT01451697|"     The primary aim of this pilot randomized controlled trial is to examine whether cognitive     remediation, compared to a placebo, improves attention and related cognitive functions in     patients with compulsive hoarding. The primary hypothesis is that compulsive hoarding     patients who are treated with cognitive remediation will demonstrate improved cognitive     skills at post-treatment compared to patients receiving placebo. This will be especially true     of attention; memory and executive function skills may also be improved.   "
140039|NCT01451684|"     This is an observational study to aid in the development of a non-invasive prenatal test that     may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and     asked to provide a blood sample to be used for general test development purposes.   "
140040|NCT01451671|"     This is an observational study to develop and evaluate a blood based prenatal blood test.     Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be     eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical     data that will be recorded on a case report form. All samples and clinical data will be     stripped of subject identifiers prior to submission to Ariosa.   "
140041|NCT01451658|"     Patients with hepatocellular carcinoma and esophageal varices bleeding were randomized to     undergo endoscopic ligation alone (group A) and additive propranolol treatment (group B)     after stabilization of their first acute bleeding.   "
140042|NCT01451645|"     The purpose of this study is to determine if once-daily treatment with colchicine, compared     to placebo, is effective in preventing gout flares in patients who are initiating therapy     with allopurinol.   "
140043|NCT01451632|"     The purpose of this study was to evaluate the safety and tolerability of escalating doses of     the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.   "
140051|NCT01451528|"     This open label trial is conducted to investigate the efficacy and safety of umbilical cord     blood therapy for chronic traumatic brain injury patients.      The study hypothesis is that the participants will show significant improvement in cognition     and function after Umbilical cord blood (UCB) transplantation.   "
140052|NCT01451515|"     This is a phase II clinical trial using risk-adapted therapy. The treatment is acute     lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of     induction, consolidation, and continuation (maintenance) phases delivered over 24-30 months.     Participants will be classified into 3 treatment stratums, based on bone marrow/peripheral     blood lymphoma cells involvement at diagnosis and day 8 for T-lymphoblastic lymphoma and bone     marrow/peripheral blood lymphoma cells involvement at diagnosis for B-lymphoblastic lymphoma.      The Primary Objective of this study is:      To improve the outcome of children with lymphoblastic lymphoma (LL) who have minimal     disseminated disease (MDD) equal to or more than 1% at diagnosis by using MDD- and minimal     residual disease (MRD)- based risk-adapted therapy.      The Secondary Objectives of this study are:        -  To determine event-free and overall survival        -  Investigate the relationship between Day 8 MRD and MDD results and EFS   "
140053|NCT01451502|"     For the next 5‐10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB)     inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While     Food and Drug Administration (FDA)‐licensed units will be prioritized, it will always be     possible that an unlicensed unit will have known attributes, making it a better source of     cells for the given indication. Because of the wide variety of current and potential     indications as a source of cells for hematopoietic reconstitution or other form of cellular     therapy, it is critical that the investigators have access to unlicensed UCB units.   "
140054|NCT01451489|"     This is a prospective,multicentre study to compare the efficacy, safety, tolerability and     relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis     (FSGS).   "
140055|NCT01451476|"     Skin aging is a complex process involving genetic and environmental factors. The     investigators hope to learn more about how human genes and their function can contribute to     skin aging and human health.   "
140056|NCT01451463|"     In individuals with Huntington's disease (HD), chorea may contribute to balance problems and     difficulties with walking, sit to stand transfers and stair climbing that in turn may     contribute to high fall rates. Xenazine (tetrabenazine) is a monoamine-depleting drug that is     commonly used to reduce chorea.      The purpose of this study is to compare: 1) spatial and temporal gait measures, 2)     performance on functional mobility measures, and 3) amount of daily walking activity before     and after administration of Xenazine in individuals with HD. It is hypothesized that the use     of Xenazine to decrease chorea will improve functions of 1) gait, 2) sit-to-stand transfers     3) stair climbing and 4) overall daily physical activity and function.   "
140057|NCT01451450|"     This study will assess the clinical potency of several exposure levels of QGE031 in     decreasing the sensitivity against peanut allergen.   "
140058|NCT01451437|"     This is a study of MK-8242 alone and in combination with cytarabine in adult participants     with refractory or recurrent acute myelogenous leukemia (AML). The study will have 2 Arms.     Arm A is for participants with refractory or recurrent AML who are considered ineligible for     standard chemotherapy. In Part 1 of Arm A, participants will receive MK-8242 monotherapy in     escalating doses to determine the recommended phase 2 dose [RP2D]. In Part 2, participants     will receive monotherapy with MK-8242 to confirm the RP2D and assess preliminary efficacy.     Arm B is for participants with recurrent AML following an initial complete remission (CR) or     CR with incomplete marrow recovery (CRi) of 6 to 12 months duration. In Part 1 of Arm B,     participants will receive MK-8242 in escalating doses + cytarabine to determine the RP2D in     combination with cytarabine. In Part 2, participants will receive MK-8242 + cytarabine to     confirm the RP2D and assess preliminary efficacy. The pharmacokinetics of MK-8242 will be     studied in both arms. With Amendment 4 (22 August 2013) a 21-day dosing cycle is added, with     MK-8242 being given on Days 1-7 of each 21-day cycle in both the monotherapy and combination     therapy arms; data from Arm A will be used to determine whether a participant receives 21-day     or 28-day therapy in Arm B.   "
140059|NCT01451424|"     To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of     Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be     administered vaginally.   "
140060|NCT01451411|"     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of     intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in     blood.   "
140063|NCT01451372|"     The aim of this study is to document the routine practice in continuous glucose monitoring     (CGM) in patients treated with sensor-augmented pump therapy and to assess clinical outcome     (HbA1c) before the start of the sensor use to the end of the follow-up period. Moreover, data     on treatment satisfaction, and fear of hypoglycemia, cost of the therapy, side effects and     treatment interruption will be collected.   "
140064|NCT01451359|"     Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized     that it could be also used for controlling persistent air leaks while maintaining the     drainage of secretions. The U.S. Food and Drug Administration approved in October 2008 the     Spiration valve system designed to control air leaks in the lung that persist after lung     surgery. This prospective observational study aims to evaluate the efficacy and safety of     Spiration endobronchial valves in a prospective series of consecutive patients with a     prolonged persistent air leak after anatomic surgical resection for cancer.   "
140065|NCT01451346|"     This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot     study to obtain data on size and variance of treatment effects in subjects with mild to     moderate Psoriasis.   "
140066|NCT01451333|"     Persistent HIV infection in the central nervous system (CNS) compartment may put subjects at     risk of developing HIV-related brain disease. Important factors associated with the     development of HIV-related brain disease include therapeutic concentrations of antiretroviral     drugs in the CNS. Conflicting evidence regarding the CNS exposure of the antiretroviral drug     used for the encore1 study, efavirenz (EFV) have been described in related studies. There     were recent study of two small series assessment of EFV exposure in the cerebral spinal fluid     (CSF); one group reported small detectable EFV concentrations, while another observed     undetectable EFV exposure in the CSF. Also, in a larger reported series comprising of 80     subjects on EFV-containing antiretroviral therapy, a CSF to plasma concentration suggested     that there is limited movement of EFV out of the CSF. In HIV-1 infected subjects at steady     state, EFV plasma level parameters are dose proportional following 200mg, 400mg, and 600mg     daily doses. The CNS exposure of EFV at different daily dosing has not been described.   "
140067|NCT01451320|"     Despite high mortality and morbidity, the best treatment strategies for prosthetic valve     thrombosis (PVT) have been controversial. In this study the investigators wanted to identify     the most effective and safe regimen among different thrombolytic strategies.Transesophageal     echocardiography (TEE) guided thrombolytic treatment was administered to 182 consecutive     patients with PVT in 220 different episodes (156 women, mean age 43.2±13.06 years) between     1993 and 2009. These regimens included rapid streptokinase (Group I, 16 episodes), slow     streptokinase (Group II, 41 episodes), high dose (100 mg) tissue plasminogen activator (t-PA)     (Group III, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-PA without bolus     (Group IV, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-PA without     bolus (Group V, 124 episodes). The study endpoints were thrombolytic success and in-hospital     mortality and non-fatal complication rates.   "
140068|NCT01451307|"     The aim of this single center study is to measure the impact of standardized neonatal     pediatric surgeries due to gastrointestinal malformations on the children's motor and     cognitive development and psycho-emotional competence.      To measure the neurodevelopment, the children will be tested with the Bayley Scales of Infant     Development II Assessment.   "
140069|NCT01451294|"     Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree     stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an     impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes     dependent on systemic blood pressure. Therefore, to maintain cerebral perfusion pressure in     this type of patients intraoperative hypotension needs to be avoided. Different short-acting     agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a drug     with vasoconstrictive properties combined with an increase in heart rate) can be used to     correct intra-operative hypotension. In healthy subjects these agents affect the cerebral     perfusion differently despite an identical effect on the systemic blood pressure. Cerebral     perfusion decreases after phenylephrine administration while it is preserved after the use of     ephedrine. The optimal agent for correcting hypotension in CEA patients, and thus in a     situation of an impaired cerebral autoregulation, is unknown.      Therefore, the investigators propose to perform a prospective study observing the effect of     phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use     of either phenylephrine or ephedrine during CEA.   "
140070|NCT01451281|"     Background:      - Duchenne muscular dystrophy (DMD) is a disease in which the muscles are unable to make the     protein dystrophin. Without this protein, the muscles become gradually weaker. A new medicine     called GSK2402968 is being tested to see if it can help prevent or slow down this loss of     muscle strength. In this study, boys with DMD and healthy volunteers will have different     types of imaging studies to see which ones provide the best images of the muscles. This     information will help researchers use these imaging techniques to test the safety and     effectiveness of GSK2402968 and other agents.      Objectives:      - To test magnetic resonance imaging and ultrasound techniques that can detect changes in     muscles of boys with DMD.      Eligibility:        -  Boys who have DMD and are in the GSK2402968 drug test study.        -  Healthy boys of the same age as the above study participants.      Design:        -  Participants will be screened with a medical history and physical exam.        -  Healthy volunteers will have one 2-hour visit with three tests. Magnetic resonance          imaging (MRI) scans of the skeletal muscles and heart and diaphragm muscles will be          carried out. Muscle ultrasound imaging of leg and arm muscles will also be done.          Participants should not perform heavy physical activity like school sports or long walks          during the week before the visit.        -  Participants in the GSK2402968 study will have the same series of tests as the healthy          volunteers. The tests will be given during the study screening phase. They will be          repeated after 3 months and 6 months of receiving the study agent (GSK2402968 or          placebo) and at 6 months after stopping the GSK study.   "
140095|NCT01450956|"     During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent     studies have suggested that the paediatric myocardium is more sensitive to hypoxia and     cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia     and reperfusion injury has been investigated widely in adults. The investigators hypothesis     that sevoflurane applied during cardiopulmonary bypass might afford better myocardial     protection during paediatric cardiac surgery.   "
140071|NCT01451268|"     The study's primary objective is to determine the maximum tolerated dose (MTD) and     dose-limiting toxicity (DLT) of Panobinostat when administered within 150 days after     hematopoietic stem cell transplantation (HSCT) and given in conjunction with standard     immunosuppressive therapy after HSCT for patients with high-risk Myelodysplastic Syndrome     (MDS) or Acute Myeloid Leukemia (AML).      Secondary objectives are        -  To determine safety and tolerability of panobinostat        -  To determine overall and disease-free survival at 12 months after HSCT        -  To evaluate immunoregulatory properties of panobinostat        -  To evaluate patient-reported health-related quality of life (HRQL)      The hypothesis of this study is that panobinostat can be an effective drug in preventing     relapse of MDS and AML patients with high-risk features after hematopoietic stem cell     transplantation with reduced-intensity conditioning (RIC-HSCT) while at the same time     reducing graft-versus-host disease (GvHD) with preservation of graft-versus-leukemia (GvL)     effect.   "
140072|NCT01451255|"     Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early     detection of Pulmonary Arterial Hypertension. A number of reports have provided some     preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by     imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI     could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).   "
140150|NCT01450228|"     KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy     to improve sleep quality in over 55 years old primary insomnia patients. This is a bridging     study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.   "
140073|NCT01451242|"     Following a brain injury (BI) in addition to all other systems, there can be a failure in the     control of the autonomic system activity. Heart rate (HR) has its own normal variability.     Heart rate is controlled by the Sympathetic and Parasympathetic systems. Therefore,     monitoring HR variability (HRV) can help us evaluate the balance of the two systems and their     efficiency.Decrease in HRV was found to be in correlation with death among patients in the     acute stage following ABI. Decrease in HRV is a pre-stage of HR irregularity and ventricular     fibrillation.This disturbance can have a great impact on the patients health condition. In     addition there was found an inverse correlation between this situation and the rehabilitation     outcomes. Based on this data there is a great importance in monitoring HRV during     rehabilitation among patients following BI while the patients are required to perform     physical activity.The aim of this work is to check whether we can replace the traditional way     of measuring HR by EKG Holter (gold standard) with a more simple,accessible tool-the POLAR     watch.      The aim of this work is to check if the data collected from a POLAR watch is reliable     compared to the data collected from an EKG holter.   "
140074|NCT01451229|"     The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of     higenamine in healthy Chinese subjects   "
140075|NCT01451216|"     Balance control is the sum action of the sense and reaction systems. In order to perform     different activities in different postures one must have the ability to control and to adjust     his balance in different conditions.A deficit in brain action following injury, disease or     aging can undermine the ability to control balance and increase the risk to fall.The     limitation in gait and mobility can increase morbidity. There is a limited number of tools     evaluating and recording balance control ability. Most of this tools are observational and     can be used in the clinical field. The aim of this work is to estimate the feasibility of an     objective tool that can evaluate balance by tracking objective quantitative measures during     the standard physical therapy session without using an expensive equipment. By using this     tool the therapist can monitor the patient and collect quantitive data while performing tasks     while keeping balance. This tool will allow the therapist to detect changes in balance and     evaluate the effect of different conditions on the patients balance. This tool is based on     the well known functional reach test. The addition of this tool to the test is the use of a     simple camera and a computer softwear that will collect the data and analyze it while     performing the test. This tool will give the therapist information on the responsiveness and     the spatiotemporal measures of the performance. The aim of this work is to check what is the     contribution of spatiotemporal measures of the functional reach test among patients suffering     from acquired brain injury to the understanding of the motor function and balance control of     people suffering from brain injury. .   "
140076|NCT01451203|"     The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with     methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis     (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of     radiographically confirmed joint damage progression over a one-year period as a primary     endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be     discontinued, and the subjects will be monitored for one more year (the follow-up period) to     investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory     purposes.   "
140077|NCT01451190|"     Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female     subjects with hair loss.   "
140078|NCT01451177|"     Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo     from scalp, to induce hair growth in male and female subjects with hair loss.   "
140079|NCT01451164|"     To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients     with schizophrenia.   "
140080|NCT01451151|"     The purpose of the the study is to evaluate the ability of injections of Ji Gami(TM) C to     induce hair growth in male and female subjects with hair loss.   "
140081|NCT01451138|"     The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji     Gami(TM) NDO to induce hair growth in male and female subjects with hair loss.   "
140082|NCT01451125|"     The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji     Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects     with hair loss.   "
140083|NCT01451112|"     Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in     male and female subjects with hair loss.   "
140084|NCT01451099|"     Evaluate the ability of Ji Gami(TM) DO to induce hair growth in male and female subjects with     hair loss.   "
140085|NCT01451086|"     Pneumococcal infection is a leading cause of death throughout the world and a major cause of     pneumonia, bacteremia, meningitis, and otitis media.      It has been established that purified pneumococcal capsular polysaccharides induce antibody     production and such antibody is effective in preventing pneumococcal disease. Clinical     studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in     polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children of two years old     and older and in adults of all ages have showed immunogenic response. In order to provide     more evidence for the immunogenicity and the safety of the vaccine, a phase III clinical     trial is planed to conduct.   "
140086|NCT01451073|"     The purpose of the study is to evaluate the ability of injections Ji Gami(TM) to induce hair     growth in male and female subjects with hair loss.   "
140098|NCT01450917|"     Diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of     3rd- 5th cervical nerve roots. Usually, It can't be evaluated from history taking and     physical examination. Thus the diaphragmatic elevation on chest radiograph is assumed to     identify the phrenic nerve dysfunction. Normally, the right diaphragm is higher than the left     side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. Although there are     several methods to determine the diaphragmatic elevation from previous studies, the accuracy,     reliability, intra and inter-observer variation are problem.      Neurotization is the effective procedure to restore upper extremity function in root avulsion     type. Phrenic nerve is one of the common donor nerves which used for this procedure. But     sometimes, concomitant injury of this nerve can occur. Therefore, the investigators     established Diaphragmatic height index (DHI) from chest radiograph to use as the diagnostic     test for phrenic nerve dysfunction.   "
140087|NCT01451060|"     Anesthesia for cesarean section has been a great challenge for the anesthesiologist, for     mother and fetus are closely related. So the challenge is to anesthetize the mother without     interfering with the physiology of the fetus. The spinal block, although safe, are not free     of complications if not treated properly, may be responsible for increased fetal morbidity.     Among the major side effects, there is hypotension, with potentially serious consequences for     the maternal-fetal dyad. Hypotension in pregnant women at low risk may not lead to major     damage, but a pregnant woman with low reserves, as is the case of pregnant women with     pre-eclampsia, any drop in blood pressure of the mother can bring harm to the welfare of     mother and fetus. Based on the above, the purpose of this study is to compare the effects of     maternal and perinatal treatment of hypotension with ephedrine or metaraminol in pregnant     women with severe preeclampsia undergoing cesarean section under spinal anesthesia. There     will be a randomized, double-blind, which will be included pregnant women with severe     preeclampsia with indication of cesarean section, gestational age above 34 weeks gestation     and only.Will be Excluded women with hemorrhagic syndromes of pregnancy, HELLP syndrome,     eclampsia, cardiovascular or cerebrovascular disease, fetal distress and absolute     contraindications to spinal anesthesia.      All patients are fully informed of the research objectives and will only be included in the     study if they agree to participate and sign the Instrument of Consent. The project was     designed following the recommendations of Resolution 196/96 of the National Health and the     Declaration of Helsinki for research involving human subjects (2000). In addition, the     project was submitted to the Ethics Committee in Research of the Institute of Integrative     Medicine Professor Fernando Figueira, is approved. The study will be conducted from June 2011     to July 2012. The study variables are: consumption of metaraminol and ephedrine before and     after birth, the occurrence of nausea and vomiting, incidence of maternal hypotension, the     occurrence of reactive hypertension, occurrence of bradycardia, pH of umbilical cord, Apgar     score 5 minutes, need for face mask ventilation and ICU admission.   "
140088|NCT01451047|"     To evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth     in male and female subjects with hair loss   "
140089|NCT01451034|"     Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color     changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical     outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to     evaluate clinical outcomes of WHYX cancers after endoscopic resection.   "
140090|NCT01451021|"     Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in     male and female subjects with hair loss.   "
140091|NCT01451008|"     The intestinal ends must be rejoined after colonic resection. Conventional methods include     sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic surgery.     The leakage of an anastomosis can cause serious consequences, such as abdominal infections     and/or sepsis. Early detection of anastomotic leakage is the best way to avoid serious     abdominal infections. The methods that are used today to detect leaks are unfortunately not     very accurate. These methods include monitoring symptoms, temperature, and CRP-levels, and     performing abdominal examinations and tomography scans. Because of the difficulties in     objectively assessing these parameters, the anastomotic leaks are often diagnosed late. When     reoperation is required, a permanent stoma may be made at the level of the sigmoid colon. The     CARP system has been developed to achieve a safe anastomosis. The CARP is designed to     providing an improved contact surface between the two intestinal ends and the ability to     precisely investigate the anastomosis during and after surgery using the catheters of the     CARP system. Standardized use of the CARP to anastomose the large intestine may provide     significant advantages in the field of colorectal surgery.   "
140092|NCT01450995|"     This is an open label, 6 month cross over study in 50 migraine patients fulfilling     International Headache Society Classification criteria for migraine headache with and without     aura having 2-6 migraines per month and not over 14 days a month of headaches in the previous     3 months. Baseline Headache Impact Test -6 (HIT-6) will be obtained and 25 patients will     administer Treximet as needed for 3 months and then 2 Aleve and 100mg Imitrex taken     concomitantly as needed for 3 months. The other 25 patients will administer 2 Aleve and 100mg     Imitrex taken concomitantly as needed for 3 months and then Treximet as needed for 3 months.     In addition to Revised Patient Perception of Migraine Questionnaire (PPMQ-R)data, a detailed     diary will be recorded regarding number of tablets taken per attack, compliance, rescue     treatment, when patients treated their migraine attack (mild, moderate, or severe), onset of     pain reduction (pain relief and pain free, and 24 hour pain relief and sustained pain free     response.   "
140093|NCT01450982|"     The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics     (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.   "
140094|NCT01450969|"     The PREFER Trial primary objective of the trial is to show how much radiation attenuation is     provided by XPF in absolute and relative terms.   "
140096|NCT01450943|"     The primary objective of this study is to assess the effectiveness of cellular dermal     replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing     diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.   "
140097|NCT01450930|"     Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement     dose in conditions of physical or psychological stress to prevent life threatening adrenal     crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g.     gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone     dose is crucial. The study is conducted to offer patients the possibility to perform     hydrocortisone self administration in emergency situations in a way of administration which     is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of     subcutaneous hydrocortisone administration will be studied and compared to intramuscular     administration.   "
140099|NCT01450904|"     Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the     less postoperative pain and shorter recovery time compared to the conventional technique.     With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more     quadriceps strength and improve functional performance after TKA. However, there was no     previous studies about the effect of quadriceps incision length in the recovery time of the     quadriceps strength. The investigators hypothesized that longer quadriceps incision affected     the longer recovery time of quadriceps strength in MIS-TKA.   "
140100|NCT01450891|"     Background: New research criteria for the diagnosis of Alzheimer's disease (AD) have recently     been developed to enable an early diagnosis of AD pathophysiology by relying on emerging     biomarkers. To enable efficient allocation of health care resources, evidence is needed to     support decision makers on the adoption of emerging biomarkers in clinical practice. The     research goals are to 1) assess the diagnostic test accuracy (of current clinical diagnostic     work-up and emerging biomarkers in Magnetic Resonance Imaging (MRI), Positron Emission     Tomography (PET) and Cerebrospinal Fluid (CSF), 2) perform a cost-consequence analysis and 3)     assess long-term cost-effectiveness by an economic model.      Methods/design: In a cohort design 304 consecutive patients suspected of having a primary     neurodegenerative disease are approached in four academic memory clinics and followed for two     years. Clinical data and data on quality of life data, costs and emerging biomarkers are     gathered.      Diagnostic test accuracy is determined by relating the clinical practice and new research     criteria diagnoses to the reference diagnosis. The clinical practice diagnosis at baseline is     reflected by a consensus procedure among experts using clinical information only (no     biomarkers). The diagnosis based on the new research criteria is reflected by decision rules     that combine clinical and biomarker information. The reference diagnosis is determined by a     consensus procedure among experts based on clinical information on the course of symptoms     over a two-year time period.      A decision analytic model is build combining available evidence from different resources     among which (accuracy) results from the study, literature and expert opinion to assess     long-term cost-effectiveness of the emerging biomarkers.      Discussion: Several other multi-centre trials study the relative value of new biomarkers for     early evaluation of AD and related disorders. The uniqueness of this study is the assessment     of resource utilization and quality of life to enable an economic evaluation. The study     results are generalizable to a population of patients who are referred to a memory clinic due     to their memory problems.   "
140101|NCT01450878|"     Background : Numerous studies have outlined the cellular pleiotropic effects of     erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as     after acute ischemic injury of the brain or the heart. However, most of these studies were     carried out in animal models and no definitive proof exists today to demonstrate that EPO has     similar beneficial effects in human pathology.      Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against     ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.   "
140102|NCT01450865|"     Slow axonal Kv7 potassium channels are found along unmyelinated axons and at the nodes of     Ranvier of myelinated axons in peripheral nerve. As such the pharmacological activation of     Kv7 channels offers a potential means of reducing the excitability of peripheral axons. To     determine whether this is the case for human peripheral myelinated axons, the effect of the     Kv7 channel agonist flupirtine on the electrical excitability of A fibres was examined in     both isolated segments of human sural nerve in vitro and in motor axons of the median nerve     supplying abductor pollicus brevis in vivo. Axonal excitability was assessed in 21 human     sural nerve fascicles in vitro and in 20 volunteers in vivo using threshold tracking in QTRAC     (© Institute of Neurology, London, UK). Strength-duration time constant, rheobase current,     relative refractory period (RRP), post spike superexcitability at 5 and 7 ms and threshold     electrotonus over the 90 100 ms period were used as indices of electrical excitability. In     addition, suppression of ectopic discharge in a model of upper limb ischaemia.   "
140103|NCT01450852|"     Exercise has been used to help prevent or slow the progression of inflammation-related     disease; however, the mechanism by which this activity may lower concentrations of     inflammatory markers remains unclear. The melanocortin receptors 1,3 and 5 (MC1R, MC3R and     MC5R) have been shown to function in an anti-inflammatory manner and have the potential to     mediate the positive immune adaptations associated with regular physical activity.      Preliminary data suggest that MC3R gene expression increases in whole blood after chronic     exercise training. The primary aim of the current study is to explore whether this change in     gene expression translates into alterations in MC1R, MC3R, or MC5R monocyte surface     expression. The secondary aim is to examine the relationship between surface expression of     these receptors and circulating inflammatory profiles.      The investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. Half     of the group will be placed on an exercise program for 15 weeks. The other half will serve as     untrained control subjects. In addition to basic anthropometric measures, the investigators     will measure concentrations of inflammatory and anti-inflammatory cytokines (ELISA) and cell     surface expression of MC1R, MC3R, and MC5R on monocytes (flow cytometry).   "
140104|NCT01450839|"     This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied     repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as     the control.   "
140105|NCT01450826|"     The objectives of the study are: 1) Primary: Assess CINV efficacy of Aprepitant in     combination with Ondansetron vs. Ondansetron alone in preventing acute and delayed CINV     (Complete Control (CC): days 1-7) in brain tumor patients during adjuvant temozolomide     therapy; and 2) Secondary: To assess the efficacy of Aprepitant in combination with     Ondansetron vs Ondansetron alone in preventing acute CINV in brain tumor patients during the     acute period (first 24 hours) of receiving adjuvant temozolomide therapy; 3)Secondary: To     assess the efficacy of Aprepitant in combination with Ondansetron vs. Ondansetron alone in     preventing delayed CINV (days 2-7); 4) Secondary: To assess the safety and tolerability of     Aprepitant administered concomitantly with Ondansetron; 5) Exploratory: To assess the time to     treatment failure of Ondansetron treatment with and without Aprepitant; 6) Exploratory: To     explore the effects of age, gender, chemotherapy history, and concomitant glucocorticoid on     the efficacy of Ondansetron treatment with and without Aprepitant; 7) Exploratory: To explore     the impact of Aprepitant on quality of life and daily function.   "
140116|NCT01450683|"     This study evaluates if itraconazole causes a reduction in the serum levels of     prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer     (CRPC).   "
140117|NCT01450670|"     A specifically formulated probiotic product comprised of defined and tested microbial strains     may afford renoprotection in what has been generally called Enteric DialysisTM. However, it     is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the     potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM)     as a dietary supplement product for patients undergoing dialysis along with standardized care     of treatment.   "
140118|NCT01450657|"     A specifically formulated probiotic product comprised of defined and tested microbial strains     may afford renoprotection in what has been generally called Enteric DialysisTM. However, it     is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the     potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM)     as a dietary supplement product for patients undergoing standardized care of treatment for     their CKD stage 3 and stage 4 conditions.   "
140162|NCT01450072|"     The Departments of Neurology and Neurosurgery are conducting this research study to evaluate     the safety and effectiveness of intravascular angioplasty for the treatment of venous     narrowing in the treatment of Multiple Sclerosis (MS).   "
140106|NCT01450813|"     The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to     the anesthesiologist about a patient's level of consciousness. The Composite Variability     Index (CVI) is a new index that may provide the anesthesiologist with more information about     the condition of the patient. The CVI is a measure of the combined variability in BIS     (bispectral index) and frontal electromyography (EMG) activity that may be useful in     assessing the nociception/anti-nociception balance for patients under general anesthesia.The     purpose of this study is to determine if a commonly used anesthetic drug (rocuronium) affects     the CVI measurement differently with different doses. Rocuronium is a neuromuscular blocking     agent (NMBA) routinely used during surgery. It is expected that the group given the highest     dose of rocuronium will have diminished CVI values.      This study will randomize patients to one of four doses of rocuronium: no rocuronium, 0.2,     0.4, and 0.6 milligrams per kilo of body weight; the last dose is the standard amount for     adults. It is expected that the group given the highest dose of rocuronium will have     diminished CVI values. By including intermediate doses, information about the function of CVI     in states of less than full muscle relaxation, or paralysis, will be obtained. This     information is critically important for the development of the composite variability index,     because during general anesthesia patients are usually maintained in a state of less than     full paralysis. If the CVI response to stimulation in the intermediate groups is similar to     the group receiving no rocuronium, the monitor may find wide clinical applicability. If the     response is similar to the maximal rocuronium group, the index may only be reliable in states     with no muscle relaxant, which will greatly limit clinical utility.   "
140107|NCT01450800|"     This is a study of patients undergoing gynecologic surgery who require post-operative     catheterization to determine if prophylactic antibiotic treatment decreases the risk of     post-operative urinary tract infection in these patients.   "
140108|NCT01450787|"     The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This     might help identify a group of patients at greater risk for dry eye complications. Diabetics     have been shown to have poor ocular surface healing and might benefit from dry eye therapy     earlier if they are shown to be at greater risk for dry eyes.   "
140109|NCT01450774|"     This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way     cross-over study in asthmatic children already treated with inhaled corticosteroids.   "
140110|NCT01450761|"     The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and     Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell     Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.   "
140111|NCT01450748|"     Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx,     is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation.     The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high     placebo effect can be observed. Sodium Alginate is an effective medication indicated for     symptomatic treatment of gastroesophageal reflux. This randomized, double-blind,     placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates     oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in     Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI)     score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS)     after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as     measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks     treatment. Safety assessments include incidence of adverse events. The study hypothesis is     sodium alginate is superior over placebo in relieving LPR symptoms.   "
140112|NCT01450735|"     The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is     indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This     study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS     device.   "
140113|NCT01450722|"     Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in     elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74     old is 4-22%. The prevalence of its milder symptomatic manifestation, intermittent     claudication among 40 years old men is about 1% and among 70 years old it is 7%. In about 10%     of the patients the ischemia worsens to threat the vitality of the limb. Although     intermittent claudication has a benign prognosis and can often treated conservatively, more     severe forms with extensive arterial obstructions require revascularization, either open     surgical or endovascular. Surgical bypass operations are currently the standard reference for     treating long femoral artery obstructions. Surgical bypass operations are accompanied by     significant acute complications and late adverse effects, especially in patients with     associated cardio-cerebrovascular and pulmonary diseases, and less invasive, safe, and     effective endovascular therapies are seeked for. The long term patency rates of infrainguinal     balloon angioplasty (PTA) vary largely in different studies but they are mostly poor when     long femoral arterial obstructions have been treated. Drug eluting stents have shown great     promise in coronary artery interventions. The purpose of this study is to compare Paclitaxel     eluting Zilver PTX nitinol stent (Cook INC) with bypass surgery using PTFE graft to proximal     popliteal artery in the treatment of long femoral artery obstructions (total length of 10-25     cm) in a prospective, randomized, Finnish multi center trial with consecutive claudicant and     chronic critical ischemia patients. The aim is to randomize altogether 400 patients during     about two years in five universities and in 2-3 central hospitals. The primary end point is     patency at 24 month follow up. Secondary end points are primary success at patient discharge,     complications, 30-day mortality, target lesion revascularization, quality of life, and     economical analysis.   "
140114|NCT01450709|"     A specifically formulated probiotic product comprised of defined and tested microbial strains     may afford renoprotection in what has been generally called Enteric DialysisTM. However, it     is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the     potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM)     as a dietary supplement product for patients undergoing dialysis along with standardized care     of treatment.   "
140115|NCT01450696|"     This randomized, open-label, multicenter, international Phase IIIb study will compare the     efficacy and safety of two Herceptin dosing regimens in combination with     cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or     gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment     for metastatic disease will be randomized to receive Herceptin intravenously as either an     8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as     standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease     progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per     meter-squared (mg/m^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin     will be administered intravenously for 6 cycles at a dose of 80 mg/m^2 on Day 1 of each     3-week cycle. Herceptin will be continued until disease progression occurs.   "
140119|NCT01450644|"     The investigators hypothesise that H2H will result in improved symptom control and quality of     life and may be more cost-effective than standard best practice.      Interstitial Lung Disease (ILD) is a lung condition characterised by progressive scarring -     known as fibrosis. This is especially seen in patients with idiopathic pulmonary fibrosis     (IPF). There around 2,000 new patients diagnosed in the UK every year with a similar number     of deaths.      Fibrotic-ILD causes breathing to slowly deteriorate and as there is no cure, an estimated     two-thirds of patients die within five years of diagnosis. Patients suffer from many symptoms     including shortness of breath, cough, low mood and fatigue which are currently being poorly     managed. In addition, these patients suffer a poor health related quality of life whilst     dying from their disease.      In the later stages of their disease, these patients often end up in hospital (see appendix     1a) when there is no proven or effective treatment. Many die there despite wishing to be     looked after and die at home. These patients rarely receive palliative care which may help to     improve their symptoms, quality of life, address end of life planning needs and prevent     hospital admission. The Hospital2Home case conference conducted in the patient's home (or     place of their choice) aims to address this. At the case conference involving the patient,     their carers, a specialist nurse, and all the community health professionals, a care plan     specific to the patient will be developed. Each health professional will be aware of their     responsibility and duties. The investigators will look at whether this results in better     symptom control and better quality of life for the patient and their carer. The investigators     will also examine whether this prevents emergency hospital admission and allows patients to     die in their preferred place. The investigators will compare patients who receive the service     immediately with those who receive it after a delay.   "
140120|NCT01450631|"     The purpose of this study is to compare the post-surgical standard-of-care dressing to the     Prevena™ Incision Management System in women undergoing Cesarean section surgery.   "
140121|NCT01450618|"     This study will be a retrospective observational study assessing identifiable tolerability     problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV)     patients treated with cART regimens including one of four different protease inhibitors     [Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)] and the     impact of these identifiable tolerability problems on PI persistence, healthcare utilization,     and healthcare costs.   "
140122|NCT01450605|"     The purpose of this post-marketing surveillance is to investigate and confirm the type and     incidence of newly identified adverse events and any other factors affecting safety and     efficacy of Reyataz® so that the regulatory authority can manage the marketing approval     properly   "
140123|NCT01450592|"     The study is designed as an interventional (as blood investigations will be done) dietary     survey of diabetic & non-diabetic population sample of India to understand & compare dietary     patterns among them.The study objective is to find out amount of carbohydrate content of     daily diet of diabetic population study . This study does not intend to study the effect of     any drugs. There will be 2 groups : Type 2 diabetics and non diabetic population. The study     will begin after the study approval by ethics committee. The subject will involved after they     sign the consent form. The study involves general examination of patients, collection of data     like history of disease, interview by dietitian with the help of questionnaire, blood     investigations (only in diabetic population only) and glycaemic control status of only     diabetic population.The study is planned to be enroll 800 subjects (400 in each groups) from     10 study centers spread across India. The study data will be analyzed with appropriate     statistical methods.   "
140124|NCT01450579|"     This trial is to investigate the clinically recommended dosage for ASP7373 based on the     comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy     adults.   "
140125|NCT01450566|"     Ureteroscopy (URS) is minimally invasive procedure for management of renal stones. URS is     often involves concomitant of an indwelling ureteral stents. Placements of these stents     include pain, bladder irritability, infection, migration, encrustation and stones.      Pain is one of most significant problem of ureteral stents. There are no satisfactory     measures to deal with this problem. A novel approach to manage the pain is to load a drug     onto ureteral stent and deliver the drug into the urinary tract at controlled release rate.      Lidocaine has been proven to be effective for management of the pain associated with     interstitial cystitis. This agent has the potential for management of post-URS pain.   "
140126|NCT01450553|"     A 15-gene lung signature was created to identify predictive and prognostic biomarkers for     Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a     microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and     low risk cohorts with significantly different survivals.      Using fresh frozen tissue can be challenging, so this study attempts simplify the process by     migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin     Fixed Paraffin Embedded (FFPE) and RNAlater.      The gene expressions of the different tissue formats will be compared to see if the fresh     frozen tissue results are similar to the alternative tissue formats.   "
140127|NCT01450527|"     This is a prospective observational study done to know the etiology and outcomes of Acute     Respiratory Distress Syndrome.   "
140128|NCT01450514|"     This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a     single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment     with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and     clinical outcome of chronic schizophrenic patients with residual, so-called 'positive'     symptoms, as well as on cognition, motivation, subjective well-being of patients, negative     symptoms, general psychopathological symptoms and safety/tolerability.   "
140148|NCT01450254|"     The purpose of this study is to:        1. Analyze the short-term effects of external center of pressure manipulation of the foot          in idiopathic hip osteoarthritis patients during gait on:             1. Gait parameters (spatiotemporal, kinematic, and kinetic)             2. Muscle activation patterns of the lower limbs and back        2. Analyze the long-term effects (during the period of one year) of external center of          pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait          on:             1. Gait parameters (spatiotemporal, kinematic, and kinetic)             2. Motor learning and muscle activation patterns             3. Energy consumption             4. Pain, physical function, and quality of life      The hypotheses of the study, in reference to the aforementioned study objectives are:        1. Changes in foot center of pressure will have an immediate effect on gait parameters and          muscle activation patterns of the lower limbs and back.        2. Long-term manipulation of foot center of pressure, as a result of a year-long          rehabilitation program using the AposTherapy Biomechanical System, will result in          improvement in gait parameters, changes in muscle activation patterns as a result of new          motor learning, improvement in energy consumption, decrease in pain, improvement in          physical function, and improvement in quality of life.   "
140129|NCT01450501|"     Q-fever is a zoonosis caused by Coxiella burnetii, an intracellular bacterium. Since the     epidemic outbreak of acute Q-fever in Holland nearly 4030 people have been registered with     the acute form of the disease. Knowing that only 40% of all infected people develop symptoms,     the number of infected people (and potential candidates for chronic Q-fever) are much higher.     Chronic Q-fever generally manifest itself after a couple of months or years after the primary     infection (in 1-5% of all cases). The clinical presentation can be a life-threatening and     frequently underdiagnosed disease, as endocarditis, infected aneurysm and vascular prosthesis     or chronic Q-fever related to pregnancy and immunecompromised patients. That's why a     screening program is started in the endemic area and trace patients with chronic Q-fever. So     eventually, a greater group of patients with chronic vascular Q-fever can be described. In     addition, there is still no therapeutic guideline for management of chronic Q-fever in     patient with a vascular chronic Q-fever.      Patients with an aneurysm or vascular graft will be screened for chronic Q-fever. Patients     with chronic Q-fever will be included in a follow-up program, in which additional research     and treatment will start. The initial treatment of patients with chronic Q-fever is     doxycycline and hydroxychloroquine for at least 18 months. In addition, patients will be     monitored in 3-monthly controls, blood samples and imaging will be done. Parameters as     complaints, titers, circulating DNA, grow of aneurysm, complications etc. will be     investigated.      Ultimately, the current therapeutic guideline for management of C. burnetii will be evaluated     if it can also be applied for patients with vascular chronic Q-fever.   "
140130|NCT01450488|"     The purpose of this study is to evaluate the activity of oral AB1010, administered at two     dose levels during 3 years to patients with primary or secondary progressive multiple     sclerosis.   "
140131|NCT01450475|"     Cardiac surgery is associated with cardiac and cerebral injury because of     ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC),     have been shown to reduce the extent of myocardial infarction (MI). As another ischemic     conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose     of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic     postconditioning in children undergoing cardiac surgery, as a single-center, randomized     controlled trial.   "
140132|NCT01450462|"     Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in     the vagina declines and is replaced by other bacterial species. BV is the most common vaginal     infection worldwide, but the etiology of this complex condition is not clear. BV is     associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental     reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the     United States (US): 23% of white women versus. 52% of black women have BV. The investigators     hypothesize that inadequate vitamin D contributes to BV development and/or recurrence.     Vitamin D is essential to immune function, serving both to stimulate mechanisms associated     with pathogen elimination and to regulate immune response. According to     nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two     recent analyses, low vitamin D was associated with higher BV prevalence in pregnant     African-Americans; a third replicated this finding in pregnant African-American and white     women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to     assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a     public sexually transmitted disease (STD) clinic. This small (n=150), two-arm,     placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform     the development of future large-scale RCT design and implementation.   "
140133|NCT01450449|"     This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two     treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status     and extent of the surgical resection.      This study will assess the effect of a one-week radiotherapy regimen in comparison with a     three-week radiotherapy regimen on the survival of elderly and/or frail patients with     glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly     and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% -     100%).   "
140134|NCT01450436|"     Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since     the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic     input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and     strategies have significantly evolved during these last years, influenced by Baker     nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could     perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity     and cardio-vascular pathology prevalence in this target population at adulthood. In this     context many studies emerged since 2000 and try to assess the trade-off between     neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between     heterogenous proteic input dispensed in our NICU (described by tercil methods on population)     and fat mass phenotype variations at discharge (described by tercil methods); and its     consequences on neurodevelopmental growth. Understanding how particular nutritional     exposition could determine fatty phenotype and impact neurodevelopment is clearly our main     goal.   "
140135|NCT01450423|"     Epilepsy is a chronic neurologic disorder characterized by seizures. Beside seizures people     suffering from epilepsy experience several challenges related to education, work and everyday     life such as learning-, problem-solving-, memory-, concentration-, attention difficulties and     fatigue.      It is generally approved that physical activity (PA) has a positive effect on physical as     well as mental factors. However, people with epilepsy are found to be less active and PA is     rarely offered or recommended as supplement to anti-epileptic medical treatment. Few studies     have investigated the effect of PA in subjects with epilepsy and additional studies of high     methodical quality are needed to enable evidence-based information and counselling.      This study is carried through as a randomized controlled trial which investigates the effect     of participation in a 10-week cardio exercise program in people with Juvenile Myoclonic     Epilepsy aged 15-50.      The study hypothesis is that participation in a 10-week cardio exercise program will induce a     positive change in cognitive function (concentration and attention) and possibly in     brain-derived neurotrophic factor (BDNF). In addition it is expected that the intensity and     duration of the 10-week cardio exercise program is sufficient to cause changes in     physiological parameters related to a reduced risk of lifestyle diseases.   "
140136|NCT01450410|"     Patients with premature ischemic heart disease (PIHD) and elevated levels of HDL-C present an     altered composition of high-density lipoproteins (HDL) which is associated with a loss of     their anti-atherogenic effects and of their arterial endothelium function.      Objectives: To analyse if the treatment with nicotinic acid (NA)/Laropiprant can correct the     alterations of the HDL composition and endothelial function in patients with PIHD and     elevated HDL-C.      Methods: A total of 46 subjects with PIHD who are stable in the 3 months prior to the Study,     who continue in treatment with statins and have elevated concentrations of HDL-C (HDL-C     ≥2.0mmol/L in females and ≥1.8mmol/L in males) and an LDL-C <100mg/dL. This is a     double-blind, randomised Study; after 6 weeks of lifestyle stabilisation, the subjects will     be treated with NA or placebo for 16 weeks. At the start and end of treatment, HDL     composition will be studied through density gradient preparative ultracentrifuge separation     and FBLC (fast protein liquid chromatography) and through the changes in vasodilation induced     by the endothelium through ultrasound. Primary endpoint: change in the apoA1 content     associated to treatment. Secondary endpoints: variations in the change of the brachial artery     diameter with reactive hyperaemia and changes in the content of other lipid and protein     components of HDL including apoA2, paraoxonase, amyloid A and LCAT. The changes in HDL     composition and endothelial function will be assessed with an analysis of variance with     repeated measurements and a 2x2 design.   "
140137|NCT01450397|"     The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.   "
140138|NCT01450384|"     This phase I trial studies the side effects and best dose of giving pemetrexed disodium and     sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed     disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of solid tumors     by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib     tosylate may kill more tumor cells.   "
140139|NCT01450371|"     Interferential electrical stimulation (IES) increases local blood flow. It is not known     whether increases in blood flow may be caused by inhibition of sympathetic activity, mediated     by muscle metaboreflex activity. The purpose of this study was to evaluate the effect of IES     on metaboreflex activation in healthy subjects.   "
140140|NCT01450358|"     The objective of this study is to evaluate the consumption of antimicrobial therapy in     patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to     identify the etiological agents of sepsis.   "
140141|NCT01450345|"     The study carry out is to determine whether the use of oral pregabalin premedication to     assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in     post-operative pain management.   "
140142|NCT01450332|"     The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL     prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as     major adverse treatment events (AEs). it is designed to test the hypothesis that there is a     difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using     autografts and those in which such procedure was performed with the Tavor prosthesis.   "
140143|NCT01450319|"     This national, multicenter, open-label phase 2 study without any control arm aims to evaluate     the activity of cetuximab monotherapy in the treatment of refractory colorectal cancer in     subjects with K-RAS mutated and FcγRIIa polymorphism tumors, in which there is no therapeutic     alternative for treatment. Failure of the first and second line conventional therapeutic     lines was documented.   "
140144|NCT01450306|"     The aim of the present study is to determine whether people receiving d-cycloserine and     exposure therapy show different brain reactions to symptom provocation compared to people     receiving placebo and exposure therapy.   "
140145|NCT01450293|"     Infants in malaria-endemic regions of Africa are an important target for vaccination against     malaria in view of the enormous disease burden of malaria in this population. The purpose of     this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP     candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here     has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be     protective against naturally acquired infection in the Gambia. Administration of AdCh63     ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two     weeks from the administration of routine infant immunisations, given according to the Gambian     EPI.   "
140146|NCT01450280|"     This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63     CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite     protein. All volunteers recruited will be healthy adults. They will be primed with various     doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a     booster vaccination with MVA CS administered via intramuscular route. Safety data will be     collected for each vaccination regimen. Secondary aim of this study will be to assess the     immune responses generated by vaccination.   "
140158|NCT01450124|"     To determine the safety and tolerability of BOSWELAN in subjects with multiple sclerosis or     clinically isolated syndrome and to describe the effect of Boswellic acids on the disease     activity as assessed by monthly MRI measures.   "
140147|NCT01450267|"     Cystic fibrosis (CF) is the most common inherited disease among the Caucasian population with     considerable morbidity and reduced life expectancy.      Excessive oxidants released by activated inflammatory cells and persisting infections are     considered the main mechanism of damage of respiratory epithelium in CF.Glutathione (GSH)     represents the first-line defence of the lung against oxidative stress-induced cell injury;     however, a depletion of its levels has been observed in the airways of patients affected by     CF. In vitro studies have showed that CFTR protein plays a pivotal role in transmembrane     glutathione transport. Therapeutic approaches with inhaled GSH could improve the reduced lung     antioxidant capacity in order to counterbalance the oxidant stress linked to the chronic     airway inflammation and bacterial infection.      Primary objective of the study is to investigate whether a 12 months treatment with inhaled     GSH can improve airway obstruction in CF patients. Secondary objectives include the effects     of GSH therapy on exercise capacity, body mass index (BMI), respiratory symptoms, quality of     life, frequency of pulmonary exacerbations, hospital admissions, and antibiotic     administration. Moreover the study will evaluate the effect of GSH therapy on markers of     oxidative stress in exhaled breath condensate (EBC) and in serum, and on inflammatory markers     on brushed nasal epithelial cells.   "
140149|NCT01450241|"     The purpose of this study is to determine whether short-course antibiotic therapy is safe and     effective for the treatment of cancer patients with febrile neutropenia.   "
140151|NCT01450215|"     This is:        -  A prospective, randomized, open, phase II, multi-centre, interventional study. Patients          who are in at least PR and have received lenalidomide as 2nd line treatment for MM will          be recruited.        -  The patients will be randomized into two groups. Group R will receive lenalidomide 25          mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of          lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of          every 28 day treatment cycle. Study includes a maximum of 24 cycles including two          consolidating cycles per patients.   "
140152|NCT01450202|"     Compared with performing each procedure individually, performing two combined procedures such     as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal     distension and post-procedure pain because of longer procedure time related to more bowel     insufflated gas than one procedure. To the best of the investigators knowledge, there has     been no randomized controlled trial of CO2 versus air for insufflations during combined two     procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials     concerned CO2 insufflation in patients receiving sedation during colonoscopy.      The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural     abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of     CO2 insufflation when it is used during procedure in sedated outpatients.   "
140153|NCT01450189|"     This pilot study will assess the feasibility for the potential public health benefit of     behavioral and antiretroviral interventions during acute HIV infection.      Central Hypothesis The investigators hypothesize that delivering behavioral and     antiretroviral interventions to acutely infected persons will reduce onward transmission.   "
140154|NCT01450176|"     The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine     hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution     1.5%) two times a day (BID).   "
140155|NCT01450163|"     Oxaliplatin (Ox) is part of most treatment regimens for colorectal cancer. However, it may     induce side effects, such as a specific injury to peripheral nerves called neuropathy.     Ox-induced neuropathy is frequently painful. The presence of pain after its administration     may hamper the full chemotherapeutic treatment of patients with colorectal cancer receiving     this agent. Recently, it has been suggested that the appearance of acute neuropathy after     oxaliplatin (Ox) infusion could predict the distal polyneuropathy seen some months after     treatment. These two adverse events related to Ox treatment probably share different     mechanistic backgrounds. However, recent experimental data suggest that both types of     peripheral neuropathies are able to induce central sensitization, a major step to the     occurrence of chronic pain. Pregabalin is a molecule used to teat neuropathic pain since it     can diminish the peripheral sensitization seen in this painful condition. Recently, it has     also been shown that pregabalin can be used to treat neuropathic pain related to Ox     treatment. In the present study, we will test the hypothesis that Pregabalin administrated     exclusively for three days before and three days after the Ox infusion is able to prevent the     occurrence of pain secondary to both the acute and chronic Ox-associated neuropathies. In the     classical FLOX chemotherapeutic regimen, Ox is infused in nine sessions during a six-month     period. Patients will be followed for a year and nerve conduction tests, quantitative sensory     evaluation, pain, quality of life and functional scales will be used to assess the impact of     this strategy in the prevention of pain. If this strategy proves to work, this information     will have a major impact in the cancer prognosis of patients with colorectal cancer since Ox     will be able to administer in its full dose, and will not be limited by neuropathic side     effects.   "
140156|NCT01450150|"     Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or     de-activate neurons in superficial regions of the brain through the induction of weak     electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have     shown tDCS to be effective for treating major depressive disorder (MDD), although there are     negative trials in the specialized literature. One reason for these discrepant results might     be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still     insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a     sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the     left dorsolateral prefrontal cortex is associated with a significant clinical improvement     when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS     will present with significantly higher response and remission rates at weeks 3.   "
140157|NCT01450137|"     Giant-cell arteritis (GCA) is an immune-mediated disease that mostly affects people older     than 50 years of age. Glucocorticoid (GC) treatment dramatically alters the symptoms and     course of GCA, reducing the likelihood of vascular complications that could lead e.g. to     blindness. However, relapses usually occur when GC dosages are tapered, resulting in frequent     re-treatment with high cumulative dosages of GC over time with substantial toxicity and     morbidity (e.g. diabetes mellitus, infections, enhanced cardiovascular risk, osteoporotic     fractures, cataracts).      Therefore, novel therapies are needed that effectively reduce the dose and duration of GC     treatment and provide more durable remissions of GCA.      Tocilizumab (TCZ) is a humanized monoclonal antibody directed against the human interleukin-6     receptor (IL-6R). Elevated tissue and serum levels of IL-6 have been implicated in giant cell     arteritis. Inhibition of IL-6 and/or its receptor therefore represents a new and novel     approach for the treatment of RA.      The primary endpoint is the proportion of patients that have achieved complete remission of     disease after treatment with TCZ compared to treatment with placebo at week 12. All patients     will receive glucocorticoids in a standardized form.   "
140161|NCT01450085|"     The specific aims of this project are: (1) to compare the impact of using the routine     screening and GeneXpert algorithms for TB case detection on Tuberculosis (TB)- and     HIV-related outcomes; (2) to compare the impact of using the routine screening and GeneXpert     algorithms for exclusion of TB prior to initiation of IPT and ART on TB- and HIV-related     outcomes; and (3) to assess the relative cost-effectiveness of the routine screening and     GeneXpert algorithms for TB case detection and exclusion of TB. The GeneXpert is a     disruptive technology10 that could allow TB/HIV programs in resource-limited settings to     leapfrog over solid and liquid culture-based TB diagnostic algorithms, and to remove a key     barrier to scale up of ICF and IPT.   "
140164|NCT01450046|"     The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of     pancreatic cancer cells. Therefore, the investigators must determine the safety and     tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to     cancer patients. The investigators will do this by giving participants a dose of up to1600 mg     twice a day, not to exceed 3200 mg total for 14 consecutive days.   "
140166|NCT01450020|"     This randomized clinical trial studies peer navigator education in improving survivorship     care in African American breast cancer survivors. An educational intervention involving peer     groups may help to improve the well-being and quality of life (QOL) in breast cancer     survivors   "
140167|NCT01450007|"     Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral     nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia,     improve visual analog pain scores, decrease post-operative opioid use, and decrease     post-operative nausea. No study has been published to determine if this effect is a result of     systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at     the injection site. This study is a prospective, randomized, double-blind, controlled study     to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2)     ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus     intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three     groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally     in combination with ropivacaine for interscalene brachial plexus block will yield longer     duration of sensory blockade as compared to ropivacaine alone without intravenous or     perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This     result will suggest that the effect of dexamethasone is a result of direct neuronal activity     at the injection site versus systemic absorption.   "
140168|NCT01449994|"     The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg     pain in juvenile athletes.      A randomized placebo controlled clinical trial including juvenile athletes with functional     impairment and pain in thigh, leg or foot is performed.      Hypothesis: Instrumental chiropractic treatment with the activator instrument following the     activator methods diagnostic evaluation should lead to significant improvement of     complaints and functional impairment compared to the control group treated by a deactivated     instrument following a sham evaluation protocol.   "
140169|NCT01449981|"     This study is the first to develop and test in a randomized experimental design the efficacy     of an integrated 12-step facilitation intervention tailored for young people. In the first     phase of the study, the investigators are developing and revising a preliminary manual for     the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and     subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will     integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the     preliminary integrated TSF protocol. In the second phase of the study, the investigators will     compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental     design for adolescent substance use disorder with 60 adolescents. As a result, the     investigators will examine potential mechanisms that may underlie the efficacy of iTSF in     improving alcohol and other drug use outcomes. The investigators will test group differences     on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance     and involvement) and whether these variables are associated with substance use outcomes.   "
140170|NCT01449968|"     The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce     the geriatric hospital inappropriate (especially for emergencies) to 1 month.      The primary endpoint: survival without hospitalization through the emergency inappropriate to     1 month.   "
140171|NCT01449955|"     The purpose of the proposed study is to determine if pairing reactivation of a traumatic     memory with a single administration of Rapamycin (e.g., Sirolimus) in men with combat-related     Posttraumatic Stress Disorder leads to a reduction of the emotional strength of that     particular traumatic memory.      The following hypotheses will be tested:        1. Traumatic memory reactivation paired with a single dose of Rapamycin will decrease          objective measures of stress and self-report of stress during replay of the traumatic          memory, relative to, subjects receiving placebo.        2. Pairing administration of Rapamycin with traumatic memory reactivation will decrease          symptoms of Posttraumatic Stress Disorder one month and three months later, relative to          patients receiving placebo.   "
140172|NCT01449942|"     The purpose of this study is to determine whether an EBV-LMP1 targeted DNAzyme is effective     in radiosensitization of nasopharyngeal carcinoma in combination with standard radiation     therapy.   "
140173|NCT01449929|"     This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy     (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg     once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once     daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside     reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or     tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and     background NRTI selection. The primary analysis will take place after the last subject     completes 48 weeks on therapy; an additional analysis will be conducted after the last     subject completes Week 96 on study.   "
142701|NCT01416623|"     Henatinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and     antiangiogenic activities. This study is designed to evaluate the safety and tolerability of     Henatinib in patients with Advanced Solid Malignancies   "
140174|NCT01449916|"     This study is a randomized control trial assessing the impact of a simple evidence-based     protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a     scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood     transfusion when necessary. It is hypothesized that the protocol will significantly decrease     in-hospital mortality in patients with severe sepsis.   "
140175|NCT01449903|"     The purpose of this study is to compare three different core build-up materials for dental     use. The study hypothesis is that there is no differences in survival rate of the different     core build-ups.   "
140176|NCT01449890|"     The primary objective of this study is to test in a randomized effectiveness trial if e-mail     delivered cognitive behavioural treatment is an effective follow-up care approach in the     treatment of depression under clinically representative conditions.   "
140177|NCT01449877|"     The investigators study aims to determine the effect of prophylactic therapy with     Trimethoprim-sulfamethoxazole on the recurrences of toxoplasma retinochoroiditis gondii. This     is a randomized, double-masked, in patients with eye condition of acute Toxoplasma gondii     retinochoroiditis. Volunteers will be recruited with a previous diagnosis of chorioretinitis     presumed Toxoplasma gondii, which show active lesions compatible with recurrence. After the     acute phase of treatment of all patients [1 tablet Trimethoprim-sulfamethoxazole (800/160mg)     12/12h during 45 days], the same Stratified by gender) will be randomized in a 1:1 ratio     between the group 1 - TMP-SMZ (prophylactic treatment with trimethoprim-sulfamethoxazole 1     tablet every other day for 311 days) or group 2 - placebo (consisting of a placebo pill     containing no active ingredient of similar appearance to trimethoprim-sulfamethoxazole, 1     tablet every other day for 311 days). The primary outcomes are incidence of episodes of     recurrent chorioretinitis by toxoplasmosis in the follow up of 12, 36, 48, 60, 72, 84, 96,     108, and 120 months. Patients will be followed during the ten years in uveitis clinic at     intervals defined as follows: return weekly for 4 weeks, then monthly for 2 months, then each     3 months for 9 months, and finally annually for 10 years.   "
140178|NCT01449864|"     The primary objectives are to determine feasibility and the acute toxicity profile of proton     therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to     determine late toxicities and to generate preliminary data on clinical efficacy.   "
140179|NCT01449838|"     This is a clinical study protocol for a single centre, randomized, double blind, placebo     controlled, single and repeat dose study to investigate the safety, tolerability and     pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in     healthy Japanese male subjects.      Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or     placebo as a single dose and twice daily for 2.5 days by intravenous infusion.      Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals     after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs),     safety laboratory data, renal function and review of adverse events.   "
140180|NCT01449825|"     Pazopanib is approved by the FDA and EMA as targeted therapy for the indication of advanced     renal cell carcinoma (RCC). Hepatic safety events were observed in the pazopanib pivotal     clinical trial and the U.S. pazopanib label information contains a 'black box warning'     regarding hepatotoxicity. These clinical observations have prompted GSK to undertake a     proactive pharmacovigilance strategy focused on hepatic safety that goes beyond spontaneous     reporting of adverse events.      The goals of the study are to assess prescriber compliance with pazopanib label guidelines     for liver monitoring among patients with RCC, as well as to quantify and characterize the     hepatic safety profile of the product in real-world clinical practice compared to other     anti-vascular endothelial growth factor (anti-VEGF) drugs. As part of regulatory commitments,     GSK will conduct parallel epidemiologic analyses in different patient populations as     represented in multiple databases of electronic medical records. To enhance accrual of data,     GSK will conduct this safety surveillance program simultaneously across datasets in order to     detect and characterize all cases of liver enzyme elevations in diverse populations of     patients receiving pazopanib. Two additional goals of this study are to evaluate the     incidence of cases of combinations of liver enzyme elevations indicative of Hy's Law and     drug-induced acute liver failure among users of pazopanib compared to users of other     anti-VEGF drugs. This research effort will be coordinated by an external coordinating center.      An epidemiologic cohort study design, nested in several databases of electronic medical     information, will be employed for the research questions. Following the availability of     pazopanib in the relevant medical care system, the study will collect retrospective data at     regular intervals over the course of four years among persons exposed to pazopanib and other     anti-VEGF agents. Each patient will be characterized based on additional available     information in the database (e.g., demographics, concomitant medications). Elevations in     liver enzymes will be identified through laboratory data captured in these databases.     Potential Hy's Law and acute liver failure cases will be identified through established     screening criteria, and screen-positive cases will be reviewed by an adjudication committee     of hepatologists for final determination of drug-associated causality.   "
140181|NCT01449812|"     The purpose of this booster study is to evaluate the immune persistence in healthy Chinese     subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib)     vaccine. The study will also evaluate the safety and immune response of these subjects to a     booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.      This protocol posting deals with objectives & outcome measures of the booster phase. The     objectives & outcome measures of the primary phase are presented in a separate protocol     posting (NCT number = NCT01086423).   "
140182|NCT01449799|"     In the current study GSK961081 and fluticasone propionate will be administered in a blended     formulation from a single device and compared with GSK961081 and fluticasone propionate     administered alone and concurrently. This is a single centre, randomized, double-blind,     double dummy, single dose, four way cross-over study investigating the pharmacokinetics and     pharmacodynamics of GSK961081 and fluticasone propionate when administered alone,     concurrently and as a combination blend in healthy subjects.   "
140192|NCT01449669|"     The purpose of this study is to investigate the pharmacokinetics of cefazolin using both     plasma and microdialysate sampling methods in children with single ventricle physiology     undergoing their second palliation procedure. This will provide data to determine if the     current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue     concentrations greater than the minimum inhibitory concentrations (MIC) for common     post-surgical pathogens that cause Surgical Site Infections (SSIs).   "
140193|NCT01449656|"     The aim of this randomized prospective study is to compare two laryngeal mask airways with a     provision for evacuation of gastric contents, the LMA Proseal and The investigators     hypothesize that airway leak pressures with the LMA Proseal will be significantly different     (higher) when compared with the LMA Supreme.   "
140194|NCT01449643|"     The purpose of this study is whether an inspiratory muscle training protocol would be     associated with an improvement in of the diaphragm mobility, an increase in pulmonary     function values , gain strength and endurance of respiratory muscles and improving quality of     life.   "
140183|NCT01449786|"     More than 70% of birch pollen allergic patients suffer from allergic reactions to certain     foods, e.g. stone fruits, hazelnut and some vegetables. However, specific immunotherapy (SIT)     with birch pollen extract is not effective for the treatment of associated food allergy in a     substantial number of patients. Based on our previous clinical and immunological     investigations of birch pollen related food allergy (BPRFA) the investigators hypothesize     that for effective SIT of this abundant food allergy the disease-eliciting food allergens     should be employed. To prove this concept, the investigators aim to sublingually administer     the major apple allergen, Mal d 1, to birch pollen-allergic patients with concomitant apple     allergy and evaluate clinical and immunological effects of this treatment. The investigators     choose Mal d 1 as model food allergen because (i) its cross-reactivity with Bet v 1 has been     well characterized,(ii) apple is the most frequent trigger for BPRFA and (iii)     recombinant(r)Mal d 1 was well tolerated after sublingual administration to 20 birch     pollen-allergic patients in a previous study. Sublingual administration of a defined     concentration of GMP-rMal d 1 will be compared with equal doses of GMP-rBet v 1 as a positive     control and placebo-treatment. Clinical parameters will include skin prick tests (SPT) and     objective and subjective assessment of apple and birch pollen-induced allergic symptoms.     Immunological parameters will comprise the analysis of antibody and T cell responses to Mal d     1 and Bet v 1 as well as the evaluation of basophil activation.      The proposed pilot study will be a first investigation of the concept to specifically treat     BPRFA with the involved food allergens and thus, represents an important step in the     development of an efficient and safe therapy in the future.   "
140184|NCT01449773|"     The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients     with type 2 diabetes are now thought to be attributable to elevated intestinal production and     reduced clearance. Substantial evidence exists indicating that elevated plasma levels of     these lipoproteins are associated with increased cardiovascular disease risk. Therefore,     reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal     origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this     regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia.     However, the investigators understanding of the physiological changes that occur with n-3     PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its     impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the     intestinal production of TRLs and the expression of genes regulating intestinal lipid     absorption and chylomicron synthesis have not yet been examined in humans. The general     objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs     beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The     investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:        -  reduce TRL apoB-48 production rate and increase fractional catabolic rate of these          lipoproteins,        -  decrease the expression of genes that regulate intestinal lipid absorption and synthesis          as well as synthesis of apoB-48-containing lipoproteins,        -  decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.   "
140185|NCT01449760|"     Physical activity and in particular sport is beneficial to health. Nevertheless, some of     these activities may create a risk of injury. Ankle sprain is the most common sport related     injury. Sports that are causing the highest number of ankle sprains are: football (30%),     handball-basketball-volleyball-rugby (24%), gymnastics sports (6%), skiing (6%), cycling     (6%), athletics (4%) and contact sports (4%). A recent study in the Netherlands identified a     total of 1.3 million sports injuries. 47% of these patients required medical care. The total     costs (direct and indirect) were assessed 84.240.000 EUR per year.      Prospective studies demonstrated that athletes with a ankle sprain have a twofold risk of     re-injury during the first year after the trauma, and in half of patients with an ankle     sprain recurrence this could lead to instability or chronic pain of the ankle.      The Wii Balance Board ® is a tool that is increasingly used in the field of health. In some     hospitals, therapists are beginning to use it for the rehabilitation of patients after     surgery, fractures or strokes.      Patients are asked to complete their physical therapy session by practicing sports via     video games such as skiing, bowling or hula hoop. Currently, there are no randomized     controlled studies that publish on the effectiveness of this tool. Recently, a study     investigated the efficacy of the Wii Balance Board ® to improve balance, strength, joint     mobility and level of physical activity. After 10 weeks of training, people an increased     strength and balance was found. However, these results still require statistical     confirmation. Thus this objectives of this study are        -  To assess the efficacy of exercise training with the Wii Balance Board ® Platform        -  To evaluate the effectiveness of physical therapy (based on current guidelines)        -  To compare these two types of care (conventional physiotherapy versus Wii) to a control          group (non-treatment).   "
140186|NCT01449747|"     The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor     in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4     inhibitor   "
140187|NCT01449734|"     There is increasing awareness that high-quality care in the intensive care unit also includes     care of visiting family members according to their needs. The investigators therefore want to     assess family satisfaction using a questionnaire that was specially developed for this     setting and recently validated for German-speaking participants.   "
140188|NCT01449721|"     The purpose of this study is to assess the ability of an empiric resuscitation strategy     compared to standard care to decrease the incidence of organ failure in normotensive sepsis     patients.   "
140189|NCT01449708|"     Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after     surgery and general anesthesia. The results of our observational study indicate that 42.7% of     patients require medication to treat PONV in the first 24 hours after bariatric surgery     despite our aggressive perioperative approach with triple prophylaxis. Common risk factors     for PONV are the use of intraoperative narcotics and anesthetic gases.      Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a     reduction of narcotic consumption, desaturations and use of antiemetic medication.      Our study hypothesis is that different types of anesthetics reduce PONV further.      Patient would be randomly assigned to receive either our current intraoperative management or     a narcotic free, total intravenous general anesthetic (TIVA).      The investigators hope to improve patients' satisfaction by reducing PONV in the     postoperative period.   "
140190|NCT01449695|"     The purpose of this study is to investigate whether a nurse-based intervention, consisting of     structural informative consulting and motivational counseling, on top of usual care with or     without personalized web-based visualization of cardiovascular risk levels, improves the     medication adherence in high risk cardiovascular patients.   "
140191|NCT01449682|"     To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular     function and recalcitrant macular edema associated with retinal vein occlusion following     treatment with 2 or more prior intravitreal anti-VEGF drug injections.   "
140195|NCT01449630|"     This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to     look at safety, how well the study drug is tolerated, and how much of the study drug gets     into the blood stream and how long it takes the body to get rid of it when given to humans.     Information about any side effects that may occur will also be collected. Subjects will     participate in the study for approximately 3 months. This study is for research purposes only     and is not intended to treat any medical condition.   "
140196|NCT01449617|"     A carotid stenosis is treated with invasive procedures of revascularization when the lumen is     reduced by more than 70% or when the lumen is reduced by more than 50% in patients who have     had symptoms attributable to the affected carotid district in last the 6 months.      Two options for the treatment of patients with carotid stenosis exist currently: the     traditional surgical intervention of removal of the plaque by carotid endoarterectomy     (CEA)and percutaneous transluminal carotid angioplasty with a balloon associated to the     positioning of a stent through a catheter brought directly in the carotid artery (CAS).      The main complication of both the procedures is early thrombosis, a phenomenon in which     platelets play a central role. The importance of an effective inhibition of platelet     activation in these patients has been widely demonstrated.      Clinical studies in patients undergoing PTCA have demonstrated that the optimal treatment for     the prevention of stent thrombosis is a dual antiplatelet regimen with aspirin plus     clopidogrel, as compared with the single drugs. Given that no specific clinical trial has     assessed the best antiplatelet therapeutic regimen in CAS with stenting, by extension from     these findings in ischemic heart disease CAS patients are treated with aspirin plus     clopidogrel.      Several studies have demonstrated that an elevated residual platelet reactivity despite     treatment with clopidogrel is associated to an increased risk of major adverse cardiovascular     events (MACE) after stenting for coronary disease.      No data are instead available on the possible predictive value of residual platelet     reactivity for the incidence of ischemic cardiovascular events in patients with     atherosclerotic carotid disease undergoing CAS with stenting.      Aim of the study will be to assess the predictive value of residual platelet reactivity, as     measured by different laboratory tests in patients undergoing CAS with stenting and treated     with aspirin plus clopidogrel, for the incidence of cardiovascular complications (major     adverse ischemic events).   "
140197|NCT01449604|"     The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and     stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).   "
140198|NCT01449591|"     This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of     treatment as compared to an active control and vehicle in patients with     erythemato-telangiectatic rosacea.   "
140199|NCT01449578|"     This Phase 1 study will explore the safety, tolerability, and pharmacokinetics of single     doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID     dexpramipexole in healthy volunteers.   "
140200|NCT01449565|"     Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in     treating alcohol dependence and prevention of relapse to opioid dependence. It has shown     promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently     amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work     to determine whether monthly intramuscular injections of naltrexone will reduce     methamphetamine (meth) use among actively using, meth-dependent men who have sex with men     (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus     placebo. The investigators will focus on MSM because of the disproportionate and intertwining     epidemics of meth use and HIV in this population.   "
140201|NCT01449552|"     Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion     carries substantial risk of immunologic reaction and disease transmission. Several methods     reportedly reduce postoperative blood loss and avoid homologous blood transfusion with     traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic     acid administration was the recently adjuvant method to reduce blood loss in TKA. However,     there were several regimens in either drain clamping or tranexamic acid administration     reported in previous studies. Our objective was to compare the efficacy of our drain clamping     protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.   "
140202|NCT01449539|"     The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy     (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.   "
140203|NCT01449526|"     The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel     contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft     contact lens wearers.   "
140204|NCT01449513|"     This trial will be conducted to explore the biological effects in the skin following     treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by     reflectance confocal microscopy.   "
140205|NCT01449500|"     To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors can     eradicate H. pylori in humans in the absence of antibiotics.   "
140206|NCT01449487|"     Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic     abdominal pain and altered bowel habits in the absence of any organic cause. Patients with     IBS visit the doctor more frequently, use more diagnostic tests, consume more medications,     miss more workdays, and consume more overall direct costs than patients without IBS. More     specific treatment of the localized symptoms of IBS is therefore needed, why the present     study will investigate the effect and mechanisms of PPC-5650. PPC-5650 is a new chemical     entity that can negatively modulate the activity of Acid sensing ion channels (ASICs). It is     a potent low molecular weight inhibitor for this class of ion channels described to date.      It is hypothesized that safety, efficacy and mechanisms of local administration in the rectum     of PPC-5650 can be evaluated by use of experimental induced sensation and pain in the rectum.   "
140207|NCT01449474|"     Total knee arthroplasty (TKA) is the common and effective procedure for treatment of     end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important     factors which effects on survival of prosthesis. High percentage of misalignment has been     reported in conventional technique with using the jig based instruments. Several methods and     devices were established to solve this problem. Customized or patient matched instruments     were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With     using special software to calculate the alignment axis, it was thought that accurate     alignment can be achieved by using this instruments. Therefore, the study aimed to compare     the accuracy of MRI based patient matched instruments and jig based instruments in TKA.   "
140250|NCT01448902|"     The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to     placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a     randomised, double blind, placebo controlled, two way crossover evaluation. There will be a     screening period of up to three weeks and a washout period of at least one week between the     two treatment periods. There will be a follow up one to three weeks after the last dose of     study drug.   "
140208|NCT01449461|"     The purpose of this study is 2-fold: initially, in the dose escalation phase, the goal is to     determine the safety profile of orally administered brigatinib, including: the maximum     tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phase 2 dose (RP2D), and     pharmacokinetic (PK) profile. Then, once the RP2D is established, an expansion phase will     assess the preliminary anti-tumor activity of brigatinib, both in non-small cell lung cancer     (NSCLC) with ALK gene rearrangement (including participants with active brain metastases) or     mutated EGFR, and in other cancers with abnormal targets against which brigatinib is active.   "
140209|NCT01449448|"     Injection with corticosteroid is one of the most common non-operative interventions in the     treatment of subacromial impingement; however, its use is limited by its potential side     effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The     objective of this study was to compare the efficacy of subacromial injection of triamcinolone     compared to injection of ketorolac. Thirty-two patients diagnosed with external shoulder     impingement syndrome were included in this double-blinded randomized controlled clinical     trial. Each patient was randomized into the Steroid group or NSAID group.   "
140210|NCT01449435|"     The purpose of this study is to determine whether parameters of the pulmonary function tests     and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.   "
140211|NCT01449422|"     The main objective of this trial is to demonstrate that a local care strategy using URGO 310     3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing     in the management of venous ulcers. This non-inferiority hypothesis will be judged on the     planimetric relative regression of the wound surface area after six weeks of treatment.   "
140212|NCT01449409|"     The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of     real-time identification of uncontrolled asthma by electronic administrative records linked     to real-time notification of uncontrolled status to patients and asthma specialists with     recommended guideline directed intervention by physicians. The investigators hypothesize that     real-time outreach following National guideline asthma care recommendations, after real-time     identification of an uncontrolled asthma event in persistent asthmatics on inhaled     corticosteroids will lead to better improvements in asthma control (impairment and risk)     compared to standard asthma care outreach.   "
140213|NCT01449396|"     The aim of the study is to prove that acupuncture applied before and after embryo transfer is     able to increase pregnancy rates by means of reducing stress and improving endometrial     vascularization in women receiving in vitro Fertilization (IVF) treatments.   "
140214|NCT01449383|"     This study aims to investigate the direct effect of high amounts of dietary fibre and high     amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers     in healthy adults.   "
140215|NCT01449370|"     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal     biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when     administered orally in subjects with advanced solid malignancies.   "
140216|NCT01449357|"     A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients     with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine     Kinase Inhibitors.   "
140217|NCT01449344|"     The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose     ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with     relapsed or refractory mantle cell lymphoma.   "
140218|NCT01449331|"     The purpose of this study is:        -  to estimate the frequency of the use of non invasive ventilation        -  to estimate the frequency of the use of palliative non invasive ventilation        -  to evaluate the impact of non invasive ventilation        -  to propose some recommendations   "
140219|NCT01449318|"     The purpose of the study is to prove that pain scores generated from painful stimuli applied     preoperatively may help identify the inter-individual variability in pain perception.   "
140220|NCT01449305|"     To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline     after wearing Nanoone Woman Underwear in women with primary dysmenorrhea   "
140221|NCT01449292|"     The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System     treatment plus optimal medical therapy compared in patients with advanced upper lobe     predominant (ULP) heterogeneous emphysema.   "
140222|NCT01449279|"     To determine the safety of local palliative radiation therapy used in combination with     anti-CTLA-4 immunotherapy.   "
140223|NCT01449266|"     To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients     with chronic renal failure who require hemodialysis treatment.   "
140224|NCT01449253|"     This is an open label, randomized, interventional study indented to find the efficacy of     different treatment regimens in treatment of pulmonary hypertension secondary to lung disease     and/or hypoxia.This is to find out when to start combination therapy (sildenafil plus     bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.   "
140225|NCT01449240|"     The purpose of the study is to collect data on CSF biomarkers in patients with Hunter     Syndrome that would serve as reference data for comparison with cognitively impaired patients     with Hunter syndrome, patients with other lysosomal storage diseases, or other diseases with     CNS involvement.   "
140226|NCT01449227|"     The purpose of this prospective study is to see the natural course of adhesive capsulitis of     hip. The study is based on the hypothesis that the natural course of adhesive capsulitis of     hip is similar to that of adhesive capsulitis of shoulder. This study is also based on a     hypothesis that hip joint capsule stretching exercise will result in pain relief, recovery of     hip range of motion in months.   "
140227|NCT01449214|"     Thoracic epidural analgesia and anesthesia are effective in improving the quality of     intraoperative and postoperative pain relief during thoracic and abdominal surgical     procedures. Conventional epidural techniques have significant limitations. Due to the     anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the     insertion requires a more technically challenging paramedian approach. The safety and     feasibility of bedside ultrasonography for the lumbar spine has already been established and     it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia   "
140228|NCT01449201|"     Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to     poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor     efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based     irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50     values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus     2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II     trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and     preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The     investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with     recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.   "
140229|NCT01449188|"     Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea     and vomiting. This study, called a thorough QT study, will characterize the effects of a     single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo.     Moxifloxacin, a commercially available antibiotic known to cause a mild QT prolongation, will     be used as a positive control and will be given orally. The cardiac repolarization will be     measured by taking consecutive ECGs on a recording device known as a Holter monitor and     measuring the QT interval at specified times. In addition, blood samples will also be taken     at specified times and will be used to measure the amount of study medication in the body.   "
140230|NCT01449175|"     The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long     term safety and efficacy information about the AeriSeal System treatment in patients with     advanced emphysema.   "
140231|NCT01449162|"     The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day     versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral     corticosteroids.   "
140232|NCT01449149|"     The objectives of this study are 1) To evaluate the feasibility and acute side effects of     proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and     long term side effects of proton beam radiation for treatment of chordomas and     chondrosarcomas.   "
140233|NCT01449136|"     Dental materials with antibacterial properties can prevent the harmful effects caused by oral     cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of     antibacterial cement for sealing infected dentin in atraumatic restorations of primary     molars.   "
140234|NCT01449123|"     The primary objective in this pilot study is to explore if asthma patients prescribed fixed     dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®),     beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge     test and the following reversibility test.      The primary endpoint is to identify asthma patients responding positive or negative to the     mannitol challenge test and/or the reversibility test.      The hypothesis is that not all patients are well treated.   "
140235|NCT01449110|"     Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the     cardioprotective role of resveratrol as part of the human diet is not yet clear.      The aim of this trial is to evaluate the safety and efficacy of a resveratrol-enriched grape     extract (Stilvid) in 150 patients from both primary and secondary cardiovascular prevention.      All the patients are gold-standard medicated (statins and others). A number of cardiovascular     risk and safety markers will be evaluated after consuming 1 cap/day for 6 months and 2     caps/day for 6 additional months (total 12 months).   "
140236|NCT01449097|"     The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus     the femoral nerve block versus placebo on muscle strength in healthy volunteers. The     investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of     the quadriceps muscle strength compared to the femoral nerve block.   "
140237|NCT01449084|"     Temporary pancreatic duct stent placement during endoscopic retrograde     cholangiopancreatography (ERCP) has been recommended for post-endoscopic pancreatitis (PEP)     prophylaxis in high risk patients, including those in whom accidental pancreatic duct     cannulation has occurred. However, the optimal duration of stent placement remains an open     question. The investigators aim is to assess if immediate stent removal is effective in the     prevention of PEP after accidental pancreatic duct cannulation.   "
140238|NCT01449071|"     The primary objective of the study is to evaluate the safety, tolerability and     Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE     as add on to standard of care treatment during the trial.   "
140239|NCT01449058|"     This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum     tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally     administered combination of BYL719 and MEK162. This combination will be explored in adult     patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or     other advanced solid tumors and in adult patients with AML or high risk and very high risk     MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian     logistic regression model with overdose control. At MTD or RDE, four expansion arms will be     opened in order to further assess the safety and preliminary activity of the combination of     BYL719 and MEK162 in specific patient populations.   "
140267|NCT01448681|"     There is statistically significant correlation between invasive measures of intracranial     pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms     to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow     modeling for trend prediction of derived ICP information. Specific aims:        1. Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic          brain injury in humans.        2. Predict and anticipate changes in ICP for preemptive management purposes.        3. Analyze characteristics of changes in ICP after treatment failure.        4. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and          its treatment.        5. Test the resulting models in real time.   "
140372|NCT01447316|"     This is a short term study of the effects of bariatric surgery on body composition, gait     parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly     obese patients who are already scheduled for a bariatric surgical procedure.   "
140373|NCT01447303|"     This study will compare changes in outcomes following viscosupplementation for knee     osteoarthritis.   "
140240|NCT01449045|"     Malaria is a major public health problem. 250 million cases annually leads to approximately 1     million deaths. Over 80 per cent of these deaths occur among African children under age five.     The main interventions covered treatment with Artemisinin Combination Therapies (ACT), long     lasting bednets distribution and Rapid Diagnosis Tests (RDT) to improve malaria diagnosis.     This has led in Senegal to a substantial decrease in the incidence of malaria, in 2009.     However the recent overall decline hides the fact that malaria incidence remains very high in     the south of Senegal. That's why Home-based management (HMM) for malaria is being introduced     in selected areas. Intermittent Preventive Treatment (IPT) by monthly administration of a     therapeutic dose of antimalarials can achieve a very high degree of protection from attacks     of clinical malaria in children. The purpose of this project is to evaluate the effectiveness     of combining IPTc with HMM in southern Senegal      The study objectives are to :        -  Assess the tolerance of IPTc using SP+AQ when it is administered for a longer period in          areas with a longer transmission season,        -  Assess the added benefit that IPT with the association of Sulfadoxine-Pyrimethamine +          Amodiaquine can offer in populations where a rapid and early care with home management          of malaria is already established.        -  Determine the cost benefit ratio of the addition of IPTc with HMM. A cluster randomized          controlled trial has been designed to evaluate the effectiveness of adding seasonal IPTc          with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) for 5 months per year, in          villages where home-based management of malaria is implemented. All villages in Saraya          district, excluding 7 villages with a health post, will be eligible to participate.          Saraya villages will be combined to form 24 clusters which will be randomized to receive          HMM from a community volunteer, or IPTc plus HMM. Trained volunteer Community Medicine          Distributors (CMD) will provide HMM. The primary endpoint will be the incidence of          clinical malaria with fever or history of fever and parasitaemia with density of at          least 3000/ul. Secondary outcomes will include the safety, the tolerability, the          coverage and acceptability of the intervention. Both the recurrent and capital costs to          the health service of training staff and delivering the interventions will be estimated.          Both direct and indirect costs to users of the services (children and their families)          will also be assessed.   "
140241|NCT01449032|"     Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital     admissions for acute chest pain. In spite of improved treatments still many patients with CAD     have daily attacks of severe chest pain and severely reduced life quality.      The investigators have established a double-blind placebo-controlled trial in patients with     CAD to test efficacy and safety of treatment with adipose derived stem cells to improve     perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.   "
140242|NCT01449019|"     The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide     1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in     healthy subjects and patients with type 2 diabetes mellitus (T2DM).   "
140243|NCT01449006|"     HIV related cognitive impairment still occurs despite highly active antiretroviral therapy     (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease;     leading to varying degrees of cognitive impairment, recently termed HIV associated     neurocognitive disorders (HAND). HAND may occur in patients who are virally suppressed in     both blood and CSF.      Patients with HIV Associated Neurocognitive Disorders (HAND) who are virally suppressed in     both their blood and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral     therapy (HAART) regimen may have significant cognitive improvement with HAART intensification     with the medication Maraviroc; compared to those who remain on their existing regimen.      This study will be a prospective, interventional, randomised and unblinded controlled     clinical trial. The aim of this study will be to determine whether HAART intensification with     the medication Maraviroc, leads to significant improvement in HIV associated neurocognitive     disorders (HAND).      Patients with the recent progression (within 6 months) of HAND (validated by     neuropsychological assessment) on HAART, who are virally suppressed (<50 copies per ml) in     blood and CSF will be randomised to have their existing HAART regimen intensified with     Maraviroc, or not. The control arm will remain on their medication regimen as prescribed. The     target is to enrol 70 patients into the control group, and 70 patients into the Maraviroc     intensification group.      Patients will undergo baseline neuropsychological testing, MRI, blood tests, and     cerebrospinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the     effectiveness of adding Maraviroc, will include further neuropsychological assessment at 6     months, and neuropsychological assessment, MRI and CSF assessment again at 12 months.      Neuropsychological testing completed at 6 and 12 months will be completed by a blind     assessor, in that they will have no knowledge of which arm (treatment or control) the     participant is enrolled in.      An evaluation (neuropsychological testing) will be performed should the patient deteriorate     during the course of the study, as recognised by the patient's managing physician.      At the end of the study protocol (12 months) the patient's HAART therapy will be managed by     their primary physician.   "
140244|NCT01448993|"     Patients with difficulty in swallowing (dysphagia) or with reflux disease are frequently     found to suffer from oesophageal hypomotility (weak contractions).      Oesophageal motility is currently measured using high-resolution manometry (HRM). This     technique has a 36 pressure sensors on a plastic tube to record the pressure in side the     oesophagus.      Several pharmaceutical agents (prokinetics) can stimulate oesophageal motility. However, use     of prokinetics in patients with oesophageal hypomotility led to disappointing results. An     explanation for these disappointing results is that inappropriate patients were targeted. The     appropriate patient would be the one who still have some viable muscle in the oesophagus that     can respond to pharmacological stimuli.      In the process of developing treatment strategies in patients with oesophageal hypomotility,     testing the preserved capacity of oesophageal muscles could be useful to predict the response     of these patients to prokinetic drugs. The following tests have the potential to reveal the     preserved capacity of the oesophageal muscle to respond to stronger/medicinal stimuli.        1. - Multiple rapid swallowing (MRS) of 5ml water boluses stimulates oesophagus. A normal          response to MRS requires on the one hand integrity of neural mechanisms and on the other          hand a functional oesophageal muscle.        2. - External abdominal compression can increase the resistance to bolus transport via          oesophagus. The normal oesophagus produces contractions of higher amplitude and duration          in order to maintain a normal bolus transit.        3. - Swallowing bread boluses require stronger oesophageal contractions for a successful          bolus transit.      The purpose of the proposed project is to firstly assess the effect of Azithromycin on     oesophageal hypomotility and secondly to evaluate the predictive values of the stimulation     techniques in predicting the likelihood the positive response to drug therapy.   "
140245|NCT01448980|"     Stroke is one of the common diseases in the elderly. It is the third ranking cause of death     and affects health care system in our country. One of the most important consequences of     stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive     reflex to stimuli. It can cause contracture, limit self care function, transfer or     ambulation. Most of stroke patients have to depend on their relatives or families.   "
140246|NCT01448954|"     This study is to examine the safety, tolerability, pharmacokinetics and functional activity     of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic     asthma.   "
140247|NCT01448941|"     The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular     bridge plate fixation of the same joint in acute Lisfranc injuries.   "
140248|NCT01448928|"     This study is a regulatory post marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Zevalin for relapsed or     refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The     objective of this study is to assess safety and efficacy of using Zevalin in clinical     practice. This study is also all case investigation of which the enrollment period is five     years, and all patients who received Zevalin will be recruited and followed 13 weeks after     the administration.   "
140249|NCT01448915|"     The principal goal of this research project is to evaluate the natural history of HCV and     liver disease and its treatment in HIV-infected persons who use drugs. Research procedures     will focus on determining liver disease prevalence and severity within this population. This     is an observational study without study specific interventions.   "
140300|NCT01448252|"     This is a double blind phase I-II clinical trial with multiple autologous T cell vaccinations     using T cell lines reactive to 9 different myelin peptides of MBP, MOG and PLP, in patients     with relapsing progressive Multiple Sclerosis.   "
140251|NCT01448889|"     Acute renal failure induced by radiographic contrast agents is a known complication of     coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced     nephropathy.      The aim of the current study is to investigate the effect of normobaric hyperoxygenation     therapy on renal functions in patients at high risk for CIN undergoing coronary angiography.      The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD     equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary     angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated     congestive heart failure, hemodynamic instability, known sensitivity to contrast media and     patients who had been exposed to contrast media during the last 3 months will be excluded.     Patients with oxygen blood saturation of less than 94% at room air will also be excluded from     the study.      Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask     (treated group) or breath room air (control group) for duration of 4 hours starting at the     beginning of the angiographic procedure.      All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed     using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany).      All patients will be hospitalized 1 day before and at least 24 hours following angiography.     Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48     hours after coronary angiography. Urine sample will be taken 24 hours before angiography and     6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to     Isoprostanes and NO will be evaluated.   "
140252|NCT01448876|"     Objective was to understand the dynamics of Chlamydia trachomatis (Ct) detection by nucleic     acid amplification testing (NAAT) after treatment and consequences for test-of-cure practice.   "
140253|NCT01448863|"     The present study aims to elucidate if there is a metabolomic profile alteration in the     embryos of obese women in order to understand if the reduced implantation rate observed in     these patients is directly related to this factor. Furthermore, the investigators seek to     establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO)     and without PCO. The investigators compare these metabolomic profile embryos with embryos of     egg-donation programme.   "
140254|NCT01448850|"     The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or     severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult     subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic     Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the     underlying disease condition.   "
140255|NCT01448837|"     The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to     compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed     combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan)     administered once in the evening (20:00) in newly-diagnosed patients with exfoliation     syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated     and IOP greater than 29 mm Hg.   "
140256|NCT01448824|"     This is a 2-part study. Part 1 is to determine the safety and tolerability in healthy     subjects of increasing daily doses of LY2484595 for 14 days to achieve a blood level of     LY2484595 much higher than what is needed for therapy. The amount of study drug that reaches     the bloodstream and the time it takes for the body to get rid of it will be determined. The     effect of the study drug on factors in the blood related to cholesterol will be measured.      Part 2 is to determine how ketoconazole affects how much of the study drug, LY2484595, gets     into the bloodstream and how long it takes to get rid of it.      Information about any side effects that may occur will also be collected.   "
140257|NCT01448811|"     To compare the difference of sedation monitoring for bronchoscopic examination monitoring by     auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated     patients.   "
140258|NCT01448798|"     The purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix     during athermal nerve-sparing prostate resection compared to conventional hemostasis using     electrocautery in patients with localized prostate cancer and to investigate effects on     postoperative erectile function and continence.   "
140259|NCT01448785|"     The main objective of this post-market surveillance study is to compare the subject's weight     loss and quality of life, and device safety performance of the abiliti System and the     adjustable gastric banding therapies in obese to morbidly obese subjects.   "
140260|NCT01448772|"     This is a comparative study to assess bioavailability of a proposed alternate dosage form     against the current FDA-approved branded product.   "
140261|NCT01448759|"     The purpose of this study is to evaluate plasma alcohol concentration in patients receiving     Paclitaxel or Docetaxel infusion.   "
140262|NCT01448746|"     This study is to define the optimal method of prophylaxis for patients with gastrectomy in     Korea and the investigators hypothesized only mechanical method would be enough for     preventing VTE on perioperative period.   "
140263|NCT01448733|"     The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the     morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and     effective for the treatment of acne vulgaris.   "
140264|NCT01448720|"     The purpose of this study is to explore the efficacy of paliperidone palmitate administered     as a once monthly injection in patients with an acute exacerbation of schizophrenia.   "
140265|NCT01448707|"     The purpose of this study is to compare the efficacy, safety and tolerability of     darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing     darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors     (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who     have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral     Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function     will be compared throughout the study.   "
140266|NCT01448694|"     This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to     apply feature extraction and machine learning techniques to non-invasive hemodynamic data to     identify early signs of acute blood loss. The availability of this information may help to     establish required interventions for treating trauma patients and battlefield casualties.      Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation     process can be modeled to provide early estimations of blood loss.   "
140268|NCT01448668|"     Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu     (quercus, i.e. from oak tree) in patients with pancreatic cancer (Union for International     Cancer Control, UICC stages II-IV), in addition to conventional oncological therapy (radio-,     chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.      Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy     or disease induced symptoms (both are quality of life parameters and evaluated after 1 year);     prolongation of disease free and/or overall survival (DFS, OS) after 3 years.      Prospective observational confirmation study of previous retrospective cohort study.      As this is a non-interventional cohort study, all therapies and measurements are performed on     directive by the treating physician and/or request by the patient only.   "
140269|NCT01448655|"     Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu     (quercus, i.e. from oak tree) in patients with colorectal cancer (Union for International     Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological     therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional     therapy only.      Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy     or disease induced symptoms (both are quality of life parameters and evaluated after 1 year);     prolongation of disease free and/or overall survival (DFS, OS) after 5 years.      Prospective observational confirmation study of previous retrospective cohort study.      As this is a non-interventional cohort study, all therapies and measurements are performed on     directive by the treating physician and/or request by the patient only.   "
140270|NCT01448642|"     The purpose of this study is to determine whether a loading dose of atorvastatin before     percutaneous intervention procedures in acute coronary syndromes is effective to reduce major     cardiovascular events(MACE).   "
140271|NCT01448629|"     Introduction:      It is not an illness to have an ostomy, even though it is an indication of previous serious     illness, such as cancer, which is the reason for approximately 80% of all ostomy operations.     Ostomies can be divided into three categories: colostomy (large intestine), ileostomy (small     intestine) and urostomy (urinary tract). All require surgical redirection of the intestine or     urinary tract, allowing for elimination of urine and faeces by means of an opening in the     abdominal wall. For the population included in this study, subject with an ileostomy, colitis     ulcerosa is the main cause for an ileostomy where a surgical removal of the colon and rectum     resulting in an ileostomy in theory cures the disease.      It can be very challenging to live with an ostomy and modern ostomy products should make life     as easy as possible for people with ostomies.      Leakage and peristomal skin problems have been found to have a negative effect on the quality     of life for people with ostomies. The skin problems are the reason for one out of three     visits to ostomy nurses and occur much more frequently in people who have had ileostomies     than in those who have had colostomies. It has been observed that the prevalence of     peristomal skin problems is 21-60% among people who have ileostomies, 13-35% among those who     have colostomies and 21-48% among those who have urostomies.      Leakage from ostomies that comes into contact with the skin is thought to predispose the     patient to peristomal skin problems. One investigation of peristomal skin problems found that     77% of cases were related to contact with faeces or urine.      There are several reasons why leakage from an ostomy occurs, such as uneven peristomal area,     improper handling of the ostomy product or a problematic ostomy (its formation, its location,     retraction, prolapse or hernia). The ostomy may also change size with time, which can lead to     leakage, if the ostomy products are not adapted accordingly. As a general rule, a check-up of     the ostomy by an ostomy nurse or a doctor together with educational support can reduce these     problems. Modern ostomy products should, however, also be constantly developed in order to     lessen to the greatest extent possible the risk of leakage and associated inconveniences.   "
140272|NCT01448616|"     The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to     evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex     virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human     immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir     will reduce genital HSV shedding compared to placebo.   "
140273|NCT01448603|"     Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In     the third National Health and Nutrition Examination Surveys54.3% of the population had     positive test responses to one or more allergens, with the prevalence for short ragweed being     26.2%      The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis     symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing     visits and the post treatment challenge (PTC) visit in study TR002 approximately one year     after the start of treatment.   "
140274|NCT01448590|"     Epidural anesthesia is associated with potential risks and complications, post dural puncture     headache (PDPH) one of the most recognized with epidural or spinal anesthesia. Accidental     dural punctures occur with approximately 1.5% of all epidural attempts. Studies have     suggested that the use of an intrathecal catheter reduces the incidence of PDPH. A systematic     review of the existing literature will identify if there is reliable evidence to support this     theory. A secondary outcome, headache severity, will also be explored via incidence rates of     epidural blood patch, as this intervention is performed as a treatment for the most severe     headaches.   "
140275|NCT01448577|"     Lipoprotein lipase deficiency (LPLD) is an autosomal recessive inherited condition caused by     homozygosity or compound heterozygosity for mutations within the LPL gene. LPLD results in     subjects presenting with fasting plasma triglyceride (TG) levels of > 10 mmol/l. LPLD     typically presents in infancy or childhood with usual complaints of severe abdominal pain,     repetitive colicky pains and repeated episodes of acute pancreatitis The most severe clinical     complication associated with LPLD is acute pancreatitis. Pancreatitis in an LPLD subject     often leads to prolonged hospital admissions (sometimes up to weeks). Subjects who survive     repeated episodes of acute pancreatitis may develop chronic pancreatitis, ultimately     resulting in endocrine and exocrine pancreatic insufficiency.      The clinical manifestations of acute pancreatitis episodes related to LPLD are largely     indistinguishable from acute pancreatitis due to other causes. However, collection of data     relating to hospital admissions, laboratory test results, scan images and adverse events     occurring concomitantly to the acute pancreatic episode should allow elimination of other     causes of pancreatitis (e.g gallstones etc) and ultimately allow confirmation of LPLD-related     acute pancreatitis. Characterization of the presentation of symptoms which occur around the     time of known episodes of LPLD-related acute pancreatitis should also permit identification     of episodes of acute pancreatitis which have previously been considered as unrelated or even     unrecognized.      The objective of the study is to re-assess and re-confirm data previously recorded about the     incidence and severity of acute abdominal pancreatitis episodes in LPLD subjects previously     enrolled on AMT clinical studies. To assess and document the presentation of acute abdominal     episodes that occur around known episodes of pancreatitis and to permit the identification of     possible new previously unrecorded episodes of pancreatitis based upon predefined diagnostic     criteria. The objective is to recruit the 27 subjects previously enrolled in the above     mentioned clinical studies.   "
140301|NCT01448239|"     Primary Objective:      Injection Site Tolerability      Secondary Objectives:        -  To assess the safety profile of alirocumab SAR236553 (REGN727)        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553          (REGN727)   "
140396|NCT01447004|"     Heavy metal has been reported that it can cause attention deficit and behavioral disturbance.     The investigators hypothesis is that heavy metal is associated with children with attention     deficit/hyperactivity disorder(ADHD).   "
141049|NCT01438294|"     The purpose of this study is to assess the effects of a physical training program with active     video game in inflammatory markers, quality of life variables , clinical control and physical     and functional respiratory assessment of asthmatic children from 5 to 11 years.   "
140276|NCT01448564|"     Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and     healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible     to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs     on muscle function, exercise capacity, and cardiorespiratory responses during isometric and     dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to     severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted     in two visits each, for a total of four visits a week a part. First, a venous blood sample     will be taken from the patients. The isometric protocol will start with the determination of     the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC)     for the isometric endurance test (IET). Patients will be randomized to receive either the     placebo or LED application. Immediately after finishing this procedure, the patients will     carry out the IET until the limit of tolerance or until a 20% fall of strength is observed.     After the test, another blood sample will be taken. In the other visit (one week later), the     same order of procedures will be performed, except with the opposite (LED or placebo). For     the dynamic protocol, the same procedures described above will be followed except with the     maximal incremental cycle ergometer test used instead of the IET. The electromyography will     be recorded during the isometric and dynamic protocols. Differences in muscle function,     exercise capacity, and cardiorespiratory responses between the LED and placebo applications     will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients     with COPD by increasing exercise tolerance.   "
140277|NCT01448551|"     Obesity affects millions of American children and increases their risk of adult obesity, a     myriad of serious illnesses, increased healthcare costs, and premature death. It is vital to     find ways to reverse this epidemic. Multidisciplinary behavioral weight management programs     offer the promise of effectively treating childhood obesity. However, participants in such     programs often find it challenging to follow recommended treatment plans and frequently drop     out from programs without completing them. The proposed project aims to address these     problems through frequent contact with patients between office visits. This interim contact     will be achieved by automatically sending tailored messages to the mobile phones of     adolescents enrolled in a multidisciplinary weight management program (the MPOWER program),     as an adjunct to clinic visits.      The investigators hypothesize that program participants who receive the tailored text     messages will experience lower attrition rates, increased treatment adherence, and greater     weight loss compared to those program participants who do not receive the messages.   "
140278|NCT01448538|"     In the research study an observation of patients with wet age-related macular degeneration     (wet AMD) will be performed.      The term observational study indicates that the current course of therapy and the associated     circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs     are tested.      This study is being conducted in about 30 centers in Germany. A total of approximately 500     patients will be enrolled. The study is designed for a period of 12 months.      At the beginning and end of the study the physician will document the patient data. Therefore     will be used information from the patient records and documented visits. If such information     is not available in the study center, the otherwise attending ophthalmologist will be     consulted about the vision acuity values and visits in the observation period.      Furthermore, patients are asked to participate in three telephone interviews and fill out     during their visits to the study center a short questionnaire about their current vision and     their well-being. In the telephone interviews will be discussed with the patient about his     wet AMD disease and its treatment, its experience and its perspectives as well as any     problems occur.   "
140279|NCT01448525|"     The purpose of this study is to determine patient satisfaction with LATISSE® treatment for     increasing eyelash prominence.   "
140280|NCT01448512|"     This study will evaluate the impact of combining two evidence-based interventions: a couples     risk reduction intervention with an evidence based medication adherence intervention designed     to enhance male participation in combination with improving medication and prevention of     mother to child transmission (PMTCT) adherence in antenatal clinics (ANCs). Clinics will be     randomly assigned to experimental and control conditions and effectiveness of the combined     intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals     and clinics will be examined. It is hypothesized that community clinics implementing     PartnerPlus will have more effective PMTCT program adherence, as measured by total     participant 1) maternal and paternal ANC and PartnerPlus visits, 2) maternal and paternal     human immunodeficiency virus (HIV) Counseling & Testing (HCT) uptake, 3) maternal and infant     antiretroviral (ARV) prophylaxis uptake, 4) maternal highly active antiretroviral therapy     (HAART) uptake, 5) infant polymerase chain reaction (PCR) for HIV, and 5) maternal and infant     HIV serostatus and that community clinics implementing PartnerPlus will have reduced sexual     risk behavior, as measured by participant sexual barrier use.   "
140281|NCT01448499|"     Background: schizophrenia is a debilitating mental disorder affecting about 1% of the general     population. About 30% of patients will not react to current drug treatment and defined as     treatment-resistant schizophrenia patients (TRSP). The best studied therapeutic option for     this population is clozapine therapy. Clozapine was shown to be effective than any other     antipsychotic drug in TRSP. Moreover, augmentation of clozapine was not demonstrated to be     more effective than clozapine monotherapy. Albeit Clozapine superiority in TRSP, its use may     be involved with many adverse effects, some of them are life-threatening, and need for     routine blood tests. Amisulpride is an atypical antipsychotic drug with a different mechanism     of action than clozapine, with less adverse effects. No study compared directly amisulpride     and clozapine in TRSP.      Study objective: to compare, for the first time, the broad clinical effectiveness of     clozapine and amisulpride and their combination in TRSP.      Study Design: a clinical, prospective, naturalistic, randomized, comparative study simulating     a real-world approach of clinical decision making.      Methods: a total of 140 TRSP will be recruited from a large regional mental health center.     Participants will be randomized into two treatment groups (70 in each group): clozapine     monotherapy and amisulpride monotherapy. Assessment will be done following 10 and 20 weeks of     treatment. In case of treatment failure (insufficient clinical response or severe adverse     effect) participants will be offered either to switch to clozapine treatment (for failed     amisulpride treatment) or to augment clozapine with amisulpride (for failed clozapine     monotherapy patients). Thereafter, participants will be followed-up for a year. Assessment     will be made using clinician rated scales and self-completed questionnaires, rating the broad     phenomenology of schizophrenia (psychosis, mood, anxiety, obsessive-compulsive, cognitive and     quality of life) and drug-related adverse effects (objective and subjective).      Analysis: comparison of the effectiveness of the three treatment groups: amisulpride,     clozapine and their combination, in the various dimensions of TRSP.   "
140434|NCT01446497|"     Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic     (Timolol) ophthalmic solutions in normal tension glaucoma patients.   "
141050|NCT01438281|"     The purpose of this study is to determine whether SYL1001 is safe for the prevention and     treatment of ocular pain and dry eye syndrome.   "
140282|NCT01448486|"     HIV related cognitive impairment still occurs despite highly active antiretroviral therapy     (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease     leading to varying degrees of cognitive impairment, recently termed HIV associated     neurocognitive disorders (HAND).      HAND may occur in patients who are virally suppressed in both blood and CSF. Patients with     HIV Associated Neurological Disorders (HAND) who are virally suppressed in both their blood     and cerebrospinal fluid (CSF), whilst on a highly active antiretroviral therapy (HAART)     regimen may have significant cognitive improvement with HAART intensification with the     medication Raltegravir; compared to those who remain on their existing regimen.      This study will be a prospective, interventional, randomised and unblinded controlled     clinical trial. The aim of this study will be to determine whether HAART intensification with     the medication Raltegravir, leads to significant improvement in HIV associated neurological     disorders (HAND).      Patients with the recent progression (within 6 months) of HAND (validated by     neuropsychological assessment) on HAART who are virally suppressed (<50 copies per ml) in     blood and CSF will be randomised to have their existing HAART regimen intensified with     raltegravir 400mg twice daily, or not. The control arm will remain on their medication     regimen as prescribed. The target is to enrol 110 patients into the control group, and 110     patients into the Raltegravir intensification group.      Patients will undergo baseline neuropsychological testing, MRI, blood tests, and cerebral     spinal fluid (CSF) tests (via a lumbar puncture). The methods used to determine the     effectiveness of adding Raltegravir, will include further neuropsychological testing at 6     months; and neuropsychological testing, MRI and CSF assessment at 12 months.     Neuropsychological testing completed at 6 and 12 months will be completed by a blind     assessor, in that they will have no knowledge of which arm (treatment or control) the     participant is enrolled in.      An evaluation (neuropsychological testing) will be performed should the patient deteriorate     during the course of the study, as recognised by the patient's managing physician. The     decision of the Antiretroviral medication regimen to be used in such a case will be     determined by the managing physician. At the end of the study protocol (12 months) the     patient's HAART therapy will be managed by their primary physician.   "
140283|NCT01448473|"     Minor head injuries are a common presenting complaint in the pediatric emergency department.     Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of     minor head trauma. However, there exists ongoing controversy regarding the ideal number of     views that should be obtained in a skull series. This study aims to determine if there is a     significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of     fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film     series is provided to participating pediatric emergency physicians.   "
140284|NCT01448460|"     Vitrification is a method of cryopreserving tissue for future use. It is widely used to     preserve extra, good quality embryos generated from infertility treatments. It is becoming     popular for the preservation of oocytes (eggs) as well, but is still considered     investigational in this respect. The purpose of this study is to provide egg freezing for     patients desiring fertility preservation. Although commonly used in clinics around the world,     it should be offered as an IRB approved study procedure until it is no longer considered     investigational by the American Society of Reproductive Medicine.   "
140285|NCT01448447|"     This study will evaluate the local control rate, cosmetic results, and complication rates of     breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of     radiation therapy or as a boost technique for patients with stage I-II carcinoma of the     breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative     surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.      Hypotheses:        -  For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS),          radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is          technically feasible and reproducible with acceptable complication rates.        -  Cosmetic results after brachytherapy will be similar to that obtained after traditional          whole breast external beam radiation therapy.        -  Local tumor control rate in the breast after brachytherapy will be similar to that of          conventional external beam radiation therapy, with less inconvenience and potentially          less cost to the patient, given the selection criteria which minimize the risk of          clinically significant multicentric or extensive residual carcinoma following          lumpectomy.   "
140286|NCT01448434|"     This study is designed to know the safety and efficacy of 2 different doses of mesenchymal     stem cells in patients suffering from osteoarthritis of knee joint.   "
140287|NCT01448421|"     This is a research study using the SMT Embolic Deflection Device and involving patients with     aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic     Valve Replacement (TAVR).      The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve.     The new valve is put into place using a long, thin tube called a catheter that is inserted     into a small incision (cut) in the patient's groin and threaded through his/her arteries up     to the heart.      During the TAVR procedure, there is a risk that an abnormal particle (called embolism) could     break off from inside the arteries and travel to the brain. The embolism could be made of     clumps of blood (clots), air, part of your body tissue, or part of a medical device. If the     embolism is carried through the blood to the brain, it could cause a stroke or other     neurological (brain) problems. A stroke happens when blood flow to a part of the brain is     blocked, causing brain cells to die.      The SMT Embolic Deflection Device has been developed to prevent an embolism from going to the     brain and causing a stroke or other brain damage. The device is a wire mesh filter that     covers the vessels that carry blood to brain, deflecting any any blood clots or other     materials away from the patient's brain and towards the lower body, where they are less     likely to cause harm.   "
140288|NCT01448408|"     The present study attempts to evaluate the diagnostic capacity of a) anterior segment     parameters b) biomechanical metrics and c) a combination model, in differentiating Forme     Fruste Keratoconus (FFK) from healthy corneas.      The study adhered to the tenets of the Declaration of Helsinki and written informed consent     was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ),     in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing     primarily on the conditions of the anterior segment of the eye.      All participants underwent a complete clinical evaluation including review of medical     history, visual acuity measurements, uncorrected and best corrected visual acuity, placido     disc topography, Scheimpflug camera measurements, ORA measurements , slitlamp biomicroscopy     and fundoscopic examination.      All study participants were divided in two groups. The FFK group (FFKG) consisted of patients     with unilateral KC.      The control group (CG) was formed by refractive surgery candidates who visited EIT's     outpatients service for their preoperative examination.      CRF and CH parameters were obtained while the patient was sitting on a chair in front of the     Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device.     Upon successful fixation of the patient's eye on a red blinking target, the operator     activated the device. An air puff was released by a non-contact probe, which scanned the     central area of the eye and sent a signal to the ORA. In brief, the air puff causes the     cornea to move inward, past applanation, and into slight concavity. After milliseconds, the     air pumps shut off, the pressure decreases, and the cornea begins to return in its normal     state. The system monitors the entire process and measures two pressure values, which are     determined from the inward and outward applanation processes. The aforementioned measuring     procedure enables the determination of CH which is related to the viscoelastic structure of     the corneal tissue, and is calculated as the difference between the two pressure values at     the two applanation processes, and CRF which is indicative of the overall resistance of the     cornea and is calculated as a linear function of the two pressures associated with the two     applanation. In order to ensure accurate results, ORA was done four times for each eye, by     the same operator. Signals that differ significantly in appearance from the other signals     from the same eye were deleted.      Corneal Astigmatism (Cyl), Anterior Chamber Depth (ACD), Corneal Volume at 3mm (CV3), at 5mm     (CV5), and overall (CV), Central Corneal Thickness (CCT), Thinnest Corneal Thickness (TCT)     and TCT co-ordinates (TCTx, TCTy) were obtained using Pentacam. KISA index was calculated     using Pentacam derived topography. Pentacam is based on a rotating Scheimpflug camera and     monochromatic slit light source (a blue light emitted diode at 475 nm) which rotate together.     After proper alignment of the patient's head, a fixation target is shown which guides the     patients gaze. A real time image of the patient's eye is shown to the examiner on the     computer screen, and the image is manually focused and centered. Acceptable maps had at least     10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone     were excluded. Regarding the measuring procedure itself, patients were asked to blink and     then look at the fixation device. In case of low-quality image, the procedure was repeated     until the acceptable criteria were met.      The data from the FFKG were compared with those from the CG in separate series analyses.     Receiver operating characteristics (ROC) curves were applied to determine the overall     predictive accuracy of the test for each studied parameter, as described by the area under     the curve. We also used this approach to identify the cut-off points for studied parameters     to maximize sensitivity and specificity in discriminating FFK cases from normal corneas.     Logistic regression was used to support the cut-off point identified in the ROC curve     analysis. We determined a cutoff value that will gave us the best predictive fit for our     sample data. Furthermore, logistic regression analysis was performed to determine the     predictive capability of a model that combined both corneal biomechanical properties and     pentacam derived anterior segment parameters.      Differences between groups were evaluated using the Welch modified Student's two sample     t-test and Mann-Whitney U test, according to normality of distribution for each parameter. A     Kolmogorov-Smirnov test of normality was applied to all variables of each group. The level of     significance for each parameter was set at p<0.05. The Pearson and Spearman tests were     performed in order to assess correlations between anterior segment parameters and     biomechanical properties, depending on their parametric evaluation.   "
140290|NCT01448382|"     1. Primary Scientific Objective             -  Collect human clinical data to sustain the development of blood detection sensor               and optimize its algorithm and parameters             -  Preliminary evaluation of blood detection performances in human.        2. Secondary Scientific Objective             -  Assessment of blood detection sensor ability to identify the anatomical location               (i.e. Stomach, SB or Colon)             -  Evaluation of capsule transit characteristics in the GI tract             -  Evaluation of BBC capsule safety      Study Hypothesis:      It is estimated that by implementing a spectrophotometer technology in capsule and utilizing     the unique characteristics of light absorption by blood in specific spectrum, the capsule     will be able to automatically detect blood in the GI tract with high accuracy. As such, the     system may be an add-on to video capsules to provide efficient and quick detection of blood     presence (for example in OGBI patients) or as stand alone low cost capsule (without video)     which could serve as a tool similar to standard FOBT.   "
140435|NCT01446484|"     T regulatory cells (T regs) are responsible for immune tolerance in solid organ transplant     patients. This study will evaluate the treatment of children with kidney transplants either     with Campath and other immune system suppressing medications alone or in combination with     injection of autologous CD4+CD25+CD127lowFoxP3+ T regulatory cells expanded ex vivo. The aim     of this study is to develop a new strategy that will be more effective in preventing organ     rejection and maintaining patient health.   "
140291|NCT01448369|"     Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than     half of some Asian populations), affects the lipid producing meibomian glands in the eyelids.     One function of the glandular secretions is to reduce evaporation of the tear film. In MGD     the meibomian glands may become blocked for various reasons. The consequential retention and     stasis of the secretion increases immune response as well as scarring response. This     eventually results in an abnormal tear film and dry eye symptoms.      The current standard treatments include warm moist compresses, regular lid hygiene, oral     antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an     extended duration is important because it relieves the occlusion of blocked meibomian glands.     However, improvised methods of heating are cumbersome and inefficient requiring repeated     measures, often leading to lack of compliance. Today, there is a wider range of commercially     available devices that help to unblock meibomian glands and relief dry eye symptoms. These     devices may improve MGD treatment dramatically, but have not been tested in the warm climate     of Singapore, and are not readily available.      The current study aims to test the efficacy of treatment for devices that utilize A) warm     moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland     dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks.     The study will monitor patients for changes in tear film and lipid composition, as well as     changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented     in form of questionnaires. If the newer methods of managing MGD are found to be efficacious     and safe, these treatment measures can be made available to patients in Singapore.   "
140292|NCT01448356|"     Dry eye and ocular surface disease account for a lot of morbidity and socio-economic burden     in Asia and the rest of the world. This is a small pilot study to evaluate tear function     under different conditions of humidity and temperature. This data will be useful for     designing future trials in ocular surface and dry eye. The data will likely be used to     propose a larger national funded project involving clinical trials. This study involves     collaboration between engineers, ocular surface clinicians as well as specialists from the     defence science organisation. When successfully completed, the project will increase the     capability of Singapore Eye Research Institute and Singapore National Eye Centre to support     future industry and academic research in the ocular surface.   "
140293|NCT01448343|"     Rapid infusion of red blood cells is known to result in the increase of plasma potassium. The     researchers are trying to investigate the change in plasma potassium during rapid infusion of     mixed blood components in the reservoir of the fluid management system (FMS) in liver     transplant recipients.   "
140294|NCT01448330|"     The purpose of this study is to evaluate pharmacokinetics and safety after oral     administration of clopidogrel and aspirin in free combination as HCP0911.   "
140295|NCT01448317|"     Primary Objective:      To assess the safety and tolerability of ascending single doses of subcutaneously (SC)     administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.      Secondary Objectives:        -  To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum          low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as          total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density          lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides,          Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).        -  To assess the Pharmacokinetic profile of a single SC dose of alirocumab.        -  To assess the immunogenicity of a single SC dose of alirocumab.   "
140296|NCT01448304|"     Primary Objective:      Injection Site Tolerability      Secondary Objective:        -  To assess the safety profile of alirocumab SAR236553 (REGN727)        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553          (REGN727)   "
140297|NCT01448291|"     It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of     inflammation.      Hypothesis:      The hypothesis is that NuvaRing® will alter inflammatory biomarkers of inflammation, such as     vaginal defensin and cytokine levels, resulting in an overall anti-inflammatory milieu in the     vagina.      Specific aims of this study are to:        1. Determine biomarkers of inflammation, including defensins and cytokines, concentrations          in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use        2. Determine changes in the integrity of cervicovaginal epithelium and leukocytic          concentration before and after treatment with NuvaRing®        3. Monitor for changes in the Nugent score before and after NuvaRing® use        4. Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use        5. Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use      Methods This is a prospective, open-label, nonrandomized study. Participants will serve as     their own controls. The Clinical Research Center of Eastern Virginia Medical School, Norfolk,     Virginia, U.S.A. will be the only study site.   "
140298|NCT01448278|"     The All-inside method is a new minimally invasive procedure for anterior cruciate ligament     reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation.     In the so-called classical method, the fixation is achieved with interference screws.      The hypothesis of this study was that the All-inside technique causes less pain than the     conventional technique. The main objective was to evaluate the immediate postoperative pain     for the first ten days and at one month from the intervention.   "
140299|NCT01448265|"     Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia,     impairs quality of life and increases stroke risk and mortality. Recent clinical experience     with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can     be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF,     thereby eliminating the recurrence of AF.      Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction     during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential     mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy     times decrease with experience.      Objective: The purpose of this study is to assess safety, feasibility, and a learning curve     associated with cryoballoon catheter ablation using a novel circular mapping catheter     (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with     symptomatic paroxysmal atrial fibrillation.      The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™     mapping catheter. The reduction of procedure and fluoroscopy times during the first 40     patients treated with this approach will be analyzed to evaluate a potential learning curve     upon introduction of the technique.   "
140302|NCT01448226|"     Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in     patients (pts) with hematologic malignancies. As culture-based methods only yield results in     a minority of patients, using non-culture-based methods for detection of aspergillosis in     clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL)     samples with polymerase chain reaction (PCR) is promising, however, the influence of current     antifungal drugs on the performance of this diagnostic tool remains controversial.      The aim of the trial is to elucidate on the performance of BAL PCR under antifungal     treatment.   "
140303|NCT01448213|"     The purpose of this study is to compare two different commonly used steroid dosing regimens     after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The     investigators hope to determine if one is more effective at preventing rejection or if both     are equally effective.   "
140304|NCT01448200|"     PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a     potential treatment for hepatitis C virus infection. This study is being done to assess the     safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of     the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study     will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of     PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels)     also will be assessed.   "
140305|NCT01448187|"     The aim of the study is to describe the characteristics of patients treated with Iressa     (particularly age, gender, phenotype, histology and stage of disease, line of treatment and     previous treatments, smoking history, conditions of initiation of treatment (presence of an     EGFR-activating mutation) and to evaluate the impact of treatment on the health of the     population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and     quality of life   "
140306|NCT01448174|"     Hyperlipidemia and atherosclerosis lead to cardiovascular diseases and are an indirect cause     of increased death rate in the general population. This association is still more evident in     specific subpopulations, like patients with advanced chronic kidney disease (CKD), especially     hemodialysis (HD) patients, due to a higher prevalence of lipid disturbances and     atherosclerosis compared to the general population. Cardiovascular events in CKD patients are     frequently associated with traditional risk factors, including diabetes, male sex,     hypertension, dyslipidemia and advanced age. However, these factors failed to fully account     for the increased risk of cardiovascular events in CKD. The efforts are made to identify new     risk factors that contribute to the development of atherosclerosis and participate in causes     of cardiovascular death. In 2003, there were identified peptides designated salusin-alpha and     salusin-beta. Development of atherosclerosis may be suppressed by salusin-alpha.     Salusin-alpha may have a lipid lowering effect, similar to that of statins.      The purpose of this study is to investigate whether 1) salusin-alpha is associated with lipid     metabolism of HD patients (without or with metabolic syndrome or type 2 diabetes mellitus),     similarly or not like in healthy or obese subjects; 2) treatment with atorvastatin and its     effects are associated with changes in plasma salusin-alpha concentration, if so - whether it     is dependent on the direct influence of atorvastatin on salusin-alpha or associated with a     decrease in serum lipid level; 3) salusin-alpha may predict mortality in HD patients.   "
140307|NCT01448161|"     Study hypothesis: Machine Learning algorithms and techniques previously developed for use in     the robotics field can be applied to the field of medicine. These state-of-the-art, feature     extraction and machine learning techniques can utilize patient vital sign data from bedside     monitors to discover hidden relationships within the physiological waveforms and identify     physiological trends or concerning conditions that are predictive of various clinical events.     These algorithms could potentially provide preemptive alerts to clinicians of a developing     patient problem, well before any human could detect a worrisome combination of events or     trend in the data.      Specific aims:        1. Collect physiological waveform and numeric trend data from patient vital signs monitors          in ICUs at the University of Colorado Hospital and Children's Hospital Colorado.        2. Combine the physiological data from patient monitors with clinical data obtained from          patient Electronic Medical Records including IV fluids, medications, ventilator          settings, urine output, etc. for use in developing models of various clinical          conditions.        3. Apply Machine Learning techniques to these models to identify physiological waveform          features and trend information, which are characteristic and predictive of common          clinical conditions including but not limited to:             -  Post-operative atrial fibrillation and other cardiac dysrhythmias             -  Post-operative cardiac tamponade             -  Tension pneumothorax             -  Optimal post-operative and post-resuscitation fluid needs             -  Intracranial hypertension and cerebral perfusion pressure   "
140308|NCT01448148|"     Memory interventions are training programs that provide a variety of cognitive and     psychological strategies meant to improve memory. These interventions have been shown to     yield significant benefits to normal aged persons and small-size studies have shown that they     are suitable and beneficial for persons with mild cognitive impairment. The goal of this     proposal is to assess with a well-controlled design the efficiency and specificity of     cognitive training in persons with mild cognitive impairment.      The hypothesis is that cognitive training can improve the cognition of persons with mild     cognitive impairment and that this improvement can be enduring.   "
140309|NCT01448135|"     The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of     the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish     oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post     surgical patients in the intensive care unit (ICU). If enough patients are recruited,     inferences about impact on outcomes may also be drawn.   "
140332|NCT01447836|"     Liver injury is a complication of sepsis and septic liver injury has adverse impact upon the     outcome. As a measurement for liver function, Plasma clearance rate of indocyanine green     (PDR-ICG) always decreased during the early phase of sepsis. So the investigators hypotheses     include: PDR-ICG is lower in sepsis patients than non-septic patients in ICU; PDR-ICG may be     lower in abdominal sepsis patients than non-abdominal sepsis patients in ICU; PDR-ICG     correlates with abdominal perfusion pressure; change of PDR-ICG in early phase correlates     with change of transaminase or bilirubin in late phase of sepsis.   "
140310|NCT01448122|"     The main objective of the study is to assess the efficacy of Avène Compact Honey in     preventing pigmentation induced by visible light in subjects with a phototype III or IV.      Patients will be exposed to a range of visible light to areas on the back to confirm study     eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible     to continue.      Eligible patients will have study product applied to part of the back. The back will be     exposed to a range of light based on the minimum exposure inducing pigmentation previously     ascertained. The area where study product is applied will have a higher range of light     exposure than the area without the study product.      Seven days later, the areas will be examined to determine the lowest exposure inducing     pigmentation on the sides with and without study product. The color will also be measured     between two identical exposures with and without the applied study product.   "
140311|NCT01448109|"     The purpose of this study is to find out whether adult patients admitted to the Intensive     Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy     solution), will have an improved rate of survival 90 days later.      Septic shock is the result of an infection, which triggers a complex response by the body     (the inflammatory response) that causes a decrease in blood pressure and subsequently one or     more organ systems to fail when blood supply to these organs is reduced. This may result in     poor recovery and death. About a quarter of the people who suffer septic shock that is not     rapidly reversed, will die.      When patients are admitted to Intensive Care with sepsis and/or septic shock they receive a     number of therapies. These include fluids given through a drip, antibiotics, drugs to boost     your blood pressure and other organ systems.      In addition to these therapies, steroids (hydrocortisone) are sometimes administered. Whether     steroids are useful or not in the treatment of severe infections has been studied for more     than 50 years. Previous research has suggested that the use of low dose steroid may have     shortterm benefits in improving the circulation. However, there is no agreement amongst     doctors around the world about whether treatment with or without low dose steroids improves     the overall recovery and survival in patients with septic shock. This study would allow     doctors to make informed decisions about whether the addition of low dose steroid therapy is     better for patients with septic shock in intensive care.      The study will include 3800 intensive care patients who have septic shock. Each enrolled     patient will be randomised to receive either Hydrocortisone 200mg or placebo daily for 7 days     as a continuous intravenous infusion while in intensive care. The patient will be followed     for 90 days. If the patient is discharged prior to 90 days a telephone call will be made for     the followup information. At six months the patient will be contacted again for completion of     a quality of life questionnaire.   "
140312|NCT01448096|"     The purpose of this study is to clarify the impact of rituximab on clinical outcomes in     patients with primary breast diffuse large B-cell lymphoma and also to investigate the role     of prophylactic intrathecal chemotherapy using methotrexate for reducing central nervous     system (CNS) recurrence.   "
140313|NCT01448083|"     The purpose of this study is to determine if the measurement (with a standard nuclear camera)     of radioactivity normally present in the nervous system of your heart at four hours after the     injection of radioactive drug for your diagnostic I-123 MIBG scan is any different than     radioactivity measured in your heart at one and/or two hours after your diagnostic scan     injection. If equivalent information to the conventional 4 hr H/M ratio could be collected by     obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient acceptance     of the procedure since the requirements for obtaining a valid H/M ratio would be considerably     less time-consuming.      One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be     given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid from     receiving the small amount of radiation that is a normal part of the MIBG scan. You will then     be injected with MIBG, and you will have 10 minute pictures of your chest at 15 minutes, 1     hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These pictures will     be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner Medical     Center-Kenner. The experimental (research) part of this study is having the extra 10-minute     pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally, pictures are     only taken 24 hours after the injection. Therefore the research is limited to the four extra     pictures taken, and involve no additional injections or I-123 drug beyond that you will be     receiving regardless of whether you are part of this research.   "
140314|NCT01448070|"     This trial is conducted in Europe. The aim of this trial is to show that the product of the     new production process has a similar pharmacological profile to the traditional process used     for the current commercial product Actrapid®.   "
140315|NCT01448057|"     The study is a clinical evaluation of an over the counter (OTC) combination product     containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10     mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea,     sneezing and other symptoms due to upper respiratory tract infection (URTI).   "
140316|NCT01448044|"     The purpose of this study is to compare the sustained virologic response at post treatment     Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV)     versus placebo/PegIFNα-2a/RBV).   "
140317|NCT01448031|"     This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between     Esomeprazole and Aspirin after multiple dose administration.   "
140318|NCT01448018|"     The purpose of this study is to compare ranibizumab injection to hemodilution at the early     phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both     treatments may have a synergic effect.   "
140319|NCT01448005|"     This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35%     following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that     wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing     arrhythmic death in this select population with high risk for sudden cardiac death (SCD).     This is a pilot project to determine the feasibility of a larger-scale study.   "
140320|NCT01447992|"     A single arm, single treatment study is proposed to assess the feasibility of a portable     artificial pancreas system outside of a hospital based clinical research center.      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions     (hotel).   "
140321|NCT01447979|"     A single arm, single treatment study is proposed to assess the feasibility of a portable     artificial pancreas system outside of a hospital based clinical research center.      Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous     insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions     (hotel).   "
140370|NCT01447342|"     A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of     the cryo-touch II device for the treatment of forehead and/or glabellar lines   "
140322|NCT01447966|"     The purpose of this research study is to further investigate how well cognitive-behavioral     psychotherapy works to reduce obsessive-compulsive symptoms in young children with     obsessive-compulsive disorder (OCD). Cognitive-behavioral therapy has been shown to work well     in youth with OCD and other anxiety disorders; however, there are only a few studies to date     in preschool and young children with OCD. All children will have the option to receive 12     twice-weekly cognitive-behavioral psychotherapy sessions that are up to 60-minutes each.     Randomly determined, half of all children will receive these sessions immediately following     the pre-assessment and the remaining half will receive them after six weeks. The     investigators expect that youth receiving the study-based therapy will show more improvement     in OCD symptoms in six weeks in contrast to youth waiting to receive the therapy.   "
140323|NCT01447953|"     The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability     and facilitate return-to-work. However, there is a lack of treatment strategies that     effectively target and affect return-to-work and reduce sickness absence, and that in     addition are sufficiently easy and feasible to administer in primary care. A new activity and     life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial     barriers to rehabilitation progress, promote re-integration into life-role activities and     facilitate return-to-work. The program will be implemented and provided as one of the pain     treatment modalities available through multi-professional teams in primary care in one     Swedish county. This study aims to evaluate the effect of an activity and life-role targeting     pain rehabilitation program on the outcome variables return-to-work and sickness absence.   "
140324|NCT01447940|"     Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine     ePortal for sharing information between diabetologist and type 1 diabetic patient is not     inferior to a conventional care regarding metabolic results at 12 months.   "
140325|NCT01447927|"     This randomized phase II trial studies how well metformin hydrochloride works in preventing     esophageal cancer in patients with Barrett esophagus. Chemoprevention is the use of certain     drugs to keep cancer from forming. The use of metformin hydrochloride may keep esophageal     cancer from forming.   "
140326|NCT01447914|"     This phase II trial studies the side effects and how well tivantinib works in treating     patients with relapsed, or relapsed and refractory multiple myeloma. Tivantinib may stop the     growth of cancer cells by blocking some of the enzymes needed for cell growth.   "
140327|NCT01447901|"     LPL (Lipoprotein Lipase) is an enzyme which plays an important role in the elimination of     triglycerides (fat) and the clearance of dietary fat particles known as chylomicrons (CM) in     the blood. In patients who have an abnormal LPL gene, the enzyme does not work (total,     hereditary LPL deficiency), which results in a large increase in the amount of triglycerides     (fats) and chylomicrons in the blood. This increases the risk of inflammation in the pancreas     and leads to long term negative effects for bloods vessels (atherosclerosis). Current     medications and / or a strict and low fat diet do not sufficiently reduce the level of     triglycerides in order to prevent these conditions. To solve this problem, the company, AMT     is developing a gene therapy (AMT-011).      In normal healthy individuals, fat particles are rapidly cleared from the circulation     following a standard meal. Within approximately 3 hours the highest levels of fat is reached     and clearance is achieved within the subsequent 9 hours. In LPLD subjects, the clearance of     fat is greatly reduced as a direct consequence of the lack of LPL. During this study, a     standard meal with a tracer (3H-palmitate) is given. Since palmitate is incorporated in the     dietary fat, this study enabled monitoring of appearance of newly formed dietary fat into-     and clearance of these newly formed dietary fats from the circulation, over time.      The principal aim of the study is to verify if the gene therapy (AMT 011) is still effective     in the treatment of this condition. Systemic appearance and clearance of new formed dietary     fat particles after ingestion of the meal will be determined by measuring the level of tracer     at different time points.   "
140328|NCT01447888|"     The purpose of this study is a comparison of pain management in opioid-tolerant spine surgery     patients using a perioperative dosing goal of 150% of patient's baseline oral morphine     equivalent (OME), as compared to standard perioperative dosing, which does not currently     account for patients' baseline opiate use.   "
140329|NCT01447875|"     Hypotension and bradycardia are often observed following induction of dexmedetomidine or     propofol sedation.Cardiac preload decrease by sedative agents was often considered as one of     main causes for this hypotension.The investigators hypothesized that hypotension after     induction of sedation is caused by decrease of preload by sedative agents,and passive leg     raising (PLR)test could predict this event.Dexmedetomidine or propofol infusion in patients     with circulatory failure decrease cardiac preload and enhance preload-dependency and fluid     responsiveness.   "
140330|NCT01447862|"     Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30     million North Americans and Europeans by 2050. Atrial fibrillation is associated with     increased cardiovascular morbidity and mortality, with stroke being an especially important     and potentially devastating complication. Many studies have investigated the efficacy of     different drugs in converting atrial fibrillation to sinus rhythm. There are numerous     randomized controlled trials that have tested the efficacy of agents against placebo and some     trials that directly compared the efficacy of two or more different drugs. The class III     antiarrhythmic drug Ibutilde is approved for the acute termination of atrial fibrillation and     atrial flutter of recent onset and has been shown to be superior to sotalol and equivalent to     flecainide in this indication. Recently, the relatively atrial selective antiarrhythmic agent     vernakalant has been approved by the European Commission for the rapid conversion of recent     onset AF to sinus rhythm in adults. The investigators hypothesize that the period of time     needed for cardioversion to sinus rhythm and the efficacy of cardioversion within 90 minutes     is different between vernakalant and ibutilide in patients with recent-onset atrial     fibrillation.   "
140331|NCT01447849|"     The investigators hypothesize that the symptoms of chronic constipation in some patients are     developed due to diminished production and secretion of the alimentary tract mucus resulting     in poor lubrication.      Therefore, the investigators assume that administration of lubiprostone may restore this     lubrication impairment by stimulation of mucus production and secretion within the     gastrointestinal tract.   "
140333|NCT01447823|"     The aim of this study is to evaluate standard investigations performed in patients with bolus     impaction in a prospective observational field study. In bolus impaction, ingested food     boluses have to be endoscopically removed. Oesophageal narrowing by scar tissue caused by     reflux disease or motility disorders are possible causes of bolus impaction. How common these     causes are has up to date never been investigated. The discovery of eosinophilic oesophagitis     has broadened differential diagnosis of bolus impaction. Currently high resolution     oesophageal manometry and 24-hour pHmetry are performed in addition to endoscopy in the     assessment of bolus impaction at the University Hospital Zurich.      The collection of these examination results is the aim of this prospective unrandomised     observational field study to assess weather the currently applied procedures are valid to     diagnose the cause of impaction to find optimal therapy for each patient.   "
140334|NCT01447810|"     Hemiplegia (weakness or poor muscle function on one side of the body) is a neurological     impairment which can occur in children as a result of a brain tumor or related treatment.     This impairment can negatively impact the child's functional abilities and movement     development, making it difficult for them to play, learn to feed, dress or bathe themselves,     and to participate fully in home, daycare, or school environments. Poor movement skills may     also impact overall quality of life. Constraint Induced Therapy is a rehabilitation technique     which has been found to improve the child's abilities to move their arms following     neurological injuries like stroke and traumatic brain injury in both adults and children.      The aim of this study is to evaluate the feasibility of implementing a constraint induced     movement therapy program in a small group of children with a brain tumor and hemiplegia.     Children who participate in the program may experience improved ability to use their weak arm     leading to increased participation in meaningful activity and improved quality of life.   "
140335|NCT01447797|"     The purpose of this study is to evaluate pharmacokinetics and safety after oral     administration of Irbesartan and Atorvastatin in combination as HCP0912   "
140336|NCT01447784|"     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and     fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is     associated with poorer lung function, greater medication requirements and more asthma     symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is     evidence that HDMA leads to the development of asthma, in addition to exacerbating     pre-existing asthma in HDM-sensitised patients.      ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine,     currently being developed for the treatment of HDM allergy      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune     HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental     Exposure Chamber (EEC)).   "
140337|NCT01447771|"     Breast cancer is a common malignancy among women in the United States. There are a variety of     treatment decisions that need to be made. This study has been developed after a review of the     literature demonstrated that women with breast cancer are making decisions regarding complex     therapy issues in a way that is not congruent with their decision-making control preference.      Some patients want to be empowered with information so that they can actively participate in     the decision making about their care; others want to rely on the recommendations made by the     oncologist. This is important because patients who were not satisfied with their adjuvant     treatment decision noted a negative effect on quality of life and self image. These patients     had more difficulties with treatment side effects; including aches, hot flashes, pain, and     mood alteration. In additions the Institute of Medicine recommended that patient centeredness     be a key aim of health care organizations and that all patients be given the opportunity to     exercise the degree of control they choose over health care decisions that affect them.      It is hypothesized that women making decisions regarding adjuvant therapy who are supported     to make decisions based on their preferred level of control will have positive psychological     outcomes.   "
140338|NCT01447758|"     The purpose of this Phase Ib study is to investigate the safety, tolerability and     pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions     from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I,     II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be     performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that     increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation     of the safety and tolerability data will assess whether a stepwise increase in the percentage     of to be treated BSA is justified. Cohort IV will start dosing after finalisation of Cohort     II and after submission of data from Cohort I and II to the national authority and IEC for     review.   "
140339|NCT01447745|"     Although it is frequently mentioned in the media that overweight and obesity have reached     epidemic proportions worldwide and in this country, some Canadians are perplexed and     sometimes confused about the role of obesity in diabetes and heart disease. In fact, the     investigators even hear from time to time that there could be healthy obese individuals. In     clinical practice, assessment of obesity as a risk factor for cardiovascular disease (CVD)     remains a challenge as even some physicians are confused. However, studies conducted in our     laboratory and by other research teams around the world over the last 20 years have clearly     shown that body shape is more important than body size when evaluating the risk of     overweight/obesity and that high accumulation of abdominal fat (excess belly fat) increases     the risk of diabetes and cardiovascular disease (CVD).      The investigators now need to better understand the link between excess belly fat and     atherosclerosis (the thickening of artery walls by fatty deposits, also referred to as     atherosclerotic plaque), leading to complications such as angina (chest pain) and myocardial     infarction (heart attacks). Using non-invasive imaging techniques such as magnetic resonance     imaging, the investigators therefore propose to examine the relationships between measures of     fatness and of abdominal fat and the size of atherosclerotic plaque in large blood vessels of     apparently healthy human subjects. This study is also a unique opportunity to look, for the     first time, at the relationship between belly fat, blood sugar, several well-known risk     factors for heart disease (cholesterol, blood pressure, cardiorespiratory fitness, etc.) and     the size of atherosclerotic plaques. This research program should pave the way to the     development of new improved preventive/therapeutic approaches focusing not on body weight but     rather on abdominal fat and associated blood abnormalities which are predictive of the     development of atherosclerotic plaques leading to the premature development of heart disease.   "
140340|NCT01447732|"     This is a two-part, Phase 1 open label, multi-center, dose escalation study of     CEP-37250/KHK2804 as monotherapy in subjects with advanced solid tumors who no longer respond     to standard therapy or for whom no standard therapy is available.   "
140948|NCT01439607|"     Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the     defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside     particularly in cells of the macrophage lineage. Clinical manifestations associate     hematological, neurological and bone disorders.   "
140341|NCT01447719|"     This study is designed to test the relationship between measurements of brain amyloid using     florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by     histopathological assessment. The study will address the following specific aims:        1. To expand the number of subjects included in the A07 (NCT00857415) trial correlation          analysis (measuring the correlation between the global visual rating of brain amyloid          plaque density on an independent blinded read of the florbetapir F 18 PET scan and the          cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in          the autopsy cohort).        2. To determine the sensitivity and specificity of an independent blinded visual read          assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded          neuropathological assessment made at autopsy.   "
140342|NCT01447706|"     To determine whether the combination of MM-121 plus paclitaxel is more effective than     paclitaxel alone   "
140343|NCT01447693|"     Background.      Uremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is     regarded as one of the most bothersome symptoms in patients on chronic dialysis.      The pathogenesis of uremic itch remains unclear. Several theories have been proposed like     dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.      Many treatment modalities have been tried to reduce uremic pruritus, however , the majority     of them produced only temporary improvement. Therefore , every new therapeutic option for     uremic pruritus is desirable.      This study will undertaken to evaluate the efficacy of a cream which included olive oil and     omega-3 fatty acids.      Olive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.      The product is unique and based on patented technology developed by the Technion Research and     Development Foundation in Haifa.      Olive Omega-3 is an ointment composed of all natural ingredients. The main active ingredients     are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin with fatty     acids that are vital for its proper functioning and help in the skin recovery. Sugar cane     extract improves the skin's flexibility by removing dead cells and enhancing water retention     in the upper layer of the skin.      When applied on clean skin , the product is quickly absorbed , producing a sensation of     relief within a short time period. Treatment can be repeated as often as required with no     limitations and its use is not contraindicative of any other medical treatment.      Patients and Methods.      About 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in     the study.      All patients will undergo dermatologic examination. All patients will be score by intensity     of itching according to 3-point scale , as follows:        1. - patches of fine , powdery scales        2. - moderate scaling with beginning cracks        3. - intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for          50% of body and Vaseline ointment for the second one. The treatment will repeated twice          daily for two weeks.      At the end of 2 weeks application global tolerance will evaluate using the following 3-point     scale:        1. very good        2. good        3. poor      At the same time global agreement of the patients will evaluate according to the following     scale :        1. - very satisfactory        2. - satisfactory 3- poorly satisfactory.      Statistical analysis will be performed by use of Wilcoxon test .   "
140344|NCT01447680|"     The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody     testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma     is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™     in the USA).   "
140345|NCT01447667|"     The purpose of this study is to determine:        -  The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA          treatment        -  The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the          gold-standard histology score predicting hepatic fibrosis   "
140346|NCT01447654|"     Objective The objective of the study is to assess the structural and functional cardiac     effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM).      Design The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up     period is 12 months. 130 patients with HCM will be included in predefined subgroups. Genotype     positive relatives with borderline hypertrophy (> 13 mm) will also be included. Data on     individuals with borderline hypertrophy will be analysed separately from the rest of the     cohort.      Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall     thickness.   "
140347|NCT01447641|"     The purpose of this study is to assess both the sleep and circadian (24-hourly biological     rhythms) physiology of people with cluster headache. For sufferers with the episodic form of     the disorder this will involve observation at two separate time points, once when     experiencing attacks (in-bout) and once when attack free (out-of-bout).      The study will include measurement of basic rest-activity patterns, sleep timing and timing     of individual attacks, as well as a more detailed study recording sleep and circadian rhythms     under clinical conditions over consecutive nights.      Studying the differences in these processes in single individuals when they are both     experiencing and free from attacks might provide insight into the brain mechanisms involved     in triggering the bouts of attacks and individual attacks themselves. An improved     understanding of this area may help design improved treatment options in future.   "
140348|NCT01447628|"     This study will establish whether intravenous iron replacement has clinical benefit in     idiopathic pulmonary arterial hypertension.      A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate     whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary haemodynamics,     exercise capacity and quality of life and is well-tolerated.   "
140349|NCT01447615|"     Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda, represents     the first study that measures medium-term efficacy and cost-effectiveness of a family     economic empowerment intervention for AIDS-orphaned children. The usual care provided to AIDS     orphans in sub-Saharan Africa consists mainly of informal counseling as well as limited     material support (e.g., specifically school lunches, textbooks for the required subjects, and     note-books). Given the challenges facing these children and their caregivers, further     supports are needed in order to help them successfully make the transition from primary     school to secondary school and into adolescence. In the context of resource-poor countries,     interventions that improve families' economic capabilities are likely to be particularly     consequential. Both theory and prior research indicate that economic instability (including     poverty) constitutes one of the primary risk factors for AIDS-orphaned children's risk-taking     behaviors (including sexual risk-taking), poor mental health functioning, and poor     educational outcomes. Thus, the lack of economic security constitutes an important risk     factor for AIDS-orphaned children. Yet, to-date, few interventions aimed at care and support     of AIDS-orphaned children have incorporated components to address family-level     poverty/economic instability of the children and their caregiving families. Within this     context, there is a need for innovative interventions that promote sustainable (more than     short-term) economic and behavior change among AIDS-orphaned children and create the supports     necessary to sustain these changes.   "
141117|NCT01437410|"     The aim of this retrospective single center study was to evaluate the clinical utility of     histological and immunohistochemical analyses of specimens obtained by endoscopic     ultrasound-guided fine needle aspiration (EUS-FNA).   "
140350|NCT01447602|"     The investigators are adapting Interpersonal Psychotherapy (IPT-A) for adolescents who are     referred to emergency services either for a suicide attempt or for being evaluated as high     risk for suicidal behavior. The investigators will recruit 15 adolescents ages 12-19 years     who present with a diagnosis of major depression, dysthymic disorder, depression disorder not     otherwise specified who have a history of a suicide attempt in the past 2 months or a     non-medically lethal attempt that may require psychiatric hospitalization, suicide attempt     that is or report current suicidal ideation with a plan/intent, and treat them in an open     clinical trial. The treatment will be conducted twice weekly for the first 8 weeks of     treatment and then weekly for the remaining 12 weeks of the study. Using feedback from     clinicians and participants, the investigators will make further modifications to the manual     in preparation for conducting a larger controlled clinical trial.   "
140351|NCT01447589|"     The aim of this clinical trial is to test whether the drug nelfinavir, which can increase the     effectiveness of radiotherapy, can be given safely at the same time as a full dose of     radiotherapy for lung cancer.      It is thought that one way that nelfinavir works is through causing changes in the blood     vessels within tumours. The status of tumour blood vessels and the blood flow through them     will be investigated during the trial using special imaging techniques. The dose of radiation     used in this trial is greater than that used in previous trials with nelfinavir in other     disease settings and the response of normal lung to the combination of nelfinavir plus     radiation is unknown. Therefore, a low dose of nelfinavir will be given to the first few     patients that participate and will be gradually increased in subsequent groups of patients     provided that no worrying side effects are identified. There is a single report of serious     side-effects in an AIDs patient who was treated with radiotherapy for lung cancer when he was     also taking nelfinavir. However, in this case nelfinavir was taken at a dose 3-fold higher     than the highest dose level to be tested in this trial. An important goal of this trial is to     select the optimum dose of nelfinavir to be used in combination with lung radiotherapy, that     can then be tested more extensively in future trials.      The radiotherapy treatment in this trial has been carefully designed to minimise the amount     of healthy lung that receives radiation. Some specialised imaging techniques will be used     during radiotherapy planning and delivery to help ensure that the lung cancer is targeted     very precisely by radiation and that normal lung is avoided as much as possible.      One effect of nelfinavir is to interfere with the function of a particular protein in cells     (called AKT). The degree to which this happens can be measured in cells from blood or tissue     samples. Therefore, another aim of the study is to investigate AKT and related proteins, to     check whether nelfinavir is having the predicted effect.   "
140352|NCT01447576|"     The purpose of this study is to assess the long-term safety, tolerability and efficacy of     oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive     Disorder (MDD).   "
140353|NCT01447563|"     Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet     activation, is widely used to prevent and reduce the risk of thrombotic events. Objective:     the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75     mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period     crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral     dose of the test or reference drug will be followed by a 7 day washout period, after which     subjects will receive the alternative formulation. Blood samples were collected up to 24 h     after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel     carboxylic acid metabolite was determined using high-performance liquid chromatography-tandem     mass spectrometry area under the plasma concentration time curve from zero to the last     quantifiable level (AUC0-t), area under the plasma concentration time curve extrapolated to     infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma elimination half-life     (Tmax) and plasma half-life (T1/2) were calculated for both formulations.   "
140354|NCT01447550|"     This study assessed the effectiveness and safety of bosentan when administered to     thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was     designed,included in which patients with ulcer and/or pain at rest were treated with bosentan     p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated     to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor     amputation rate, hemodynamic changes, changes in endothelial function and angiographic     changes.      12 patients were included were current smokers. With bosentan treatment, no new ischemic     lesions were observed in all but one patient. Overall, clinical improvement was observed in     12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after     bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic     resonance image an increase of distal flow was observed in 10 out of the 12 patients. All     patients experienced a statistically significant improvement in their BAFMD values (means:1.8     at baseline;6.6 at the end of the treatment;12.7 three months after the end of the     treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of     clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves     further investigation in the management TAO patients.   "
140355|NCT01447537|"     The investigators conducted a pilot study including 17 patients with liver cirrhosis showing     that a moderate exercise programme during three months increased thigh circumference,exercise     tolerance and quality of life without adverse effects. The present study aim to more     accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory     response in patients with cirrhosis. This study will include 30 patients with compensated     liver cirrhosis that will be randomized into two groups: exercise group and control group.     Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will     be made at the beginning and at the end of the study.   "
140356|NCT01447524|"     Caloric restriction in obese diabetic patients quickly improves glucose control,     independently from weight loss. However, the early effects of a very-low calorie diet (VLCD)     on insulin sensitivity and insulin secretion in morbidly obese patients with type 2 diabetes     are still unclear.      The objective of this study was to investigate the relative contributions of insulin     sensitivity and/or secretion to the improvement in glucose metabolism, after one week of     caloric restriction, in severely obese diabetic patients.      For this purpose, hyperglycemic clamps were performed in 14 severely obese (BMI> 40 kg/m2)     patients with type 2 diabetes in good glucose control (HbA1c <7.5%), before and after 7 days     on VLCD 400 kcal/day.   "
140371|NCT01447329|"     The investigators propose to complete a randomized controlled trial to compare ear     acupuncture at Cingulate gyrus, thalamus, omega 2, shen-men, and point zero on the right and     left ear plus standard of care versus standard of care alone for symptomatic treatment of     pain following ambulatory arthroscopic knee surgery. After the subject has been discharged,     phone calls, emails or text messages will be made at 24 and 48 hours, 1 week and 1 month.     These contacts will be used to assess the subject's pain level, ambulation status, doses of     analgesics taken and time to return to full duty. At 1 week and 1 month, subjects will be     asked the PIQ-6 Pain Impact Questionnaire.   "
140357|NCT01447511|"     This research study will help determine how a person's genetic makeup affects their response     to drugs, the ability of the body to break down drugs, and their potential to experience an     interaction between drugs. The investigators are investigating the drug interactions with the     commonly used anticoagulant drug called warfarin. Warfarin is used for the treatment and     prevention of life-threatening abnormal blood clots such as deep vein thrombosis, heart     attacks, and strokes. The investigators chose warfarin for this study because it is a     commonly used drug and must be monitored closely to avoid side effects. The investigators are     interested in studying whether individuals with certain genetic profiles react differently to     warfarin when it is combined with other drugs. This research is being done to see if certain     genetic profiles require us to adjust warfarin doses differently than is needed for the     general population. Genetic profiles of subjects are determined from their participation in     the Pharmacogenetics Registry study (investigator Richard Brundage, University of Minnesota).      The study hypothesis is: Functionally defective CYP2C9 alleles attenuate the     warfarin-fluconazole inhibitory interaction and exacerbate the warfarin-rifampin inductive     interaction.   "
140358|NCT01447498|"     In a prospective randomised study design to investigate, if a systematic risk factor     screening for bleeding ulcer in patients, who following percutaneous coronary intervention     (PCI) commence a one year combination treatment with low dose aspirin and clopidogrel,     followed by prophylactic treatment with a proton pump inhibitor (PPI) in case of increased     risk, can reduce the risk of bleeding ulcer. Based on the recently raised suspicion that     PPI's, possibly except pantoprazole, reduce the effect of ADP-receptor inhibitors,     pantoprazole has been chosen as prophylaxis in the screening group, and analyses will be done     to ascertain whether PPI treatment increases the risk of coronary events. Further analyses     will be made to see whether PPI prophylaxis in high risk patients can increase compliance     with the antithrombotic treatment through a reduction of side effects, thereby reducing the     risk of myocardial infarction in particular stent thrombosis. The study population will be     analyzed further to identify the patients, who will benefit the most from PPI prophylaxis     Hypothesis: screening heart patients for risk factors for bleeding ulcer and subsequently     treating high risk patients with PPI can reduce the incidence of bleeding ulcer and increase     compliance with the antithrombotic treatment; thereby possibly reducing the risk of coronary     events and improving survival. Initial a description of the prevalence of risk factors will     be done.   "
140359|NCT01447485|"     This study will assess the pharmacokinetics and safety following single dose of valsartan in     Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.   "
140360|NCT01447472|"     The purpose of this study are:        1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and          caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism        2. to evaluate gender differences in the human pharmacology of MDMA        3. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects          and pharmacokinetics of MDMA.   "
140361|NCT01447459|"     The investigators hypothesize that reinforced asthma education improves long-term outcomes in     children with asthma.      Specific Aims and Objectives:        1. To determine the retention rate of parental knowledge about asthma;        2. To evaluate the clinical status, quality of life and healthcare costs of children with          asthma following an educational intervention.   "
140362|NCT01447446|"     This prospective, multicenter, observational cohort study will evaluate the efficacy and     safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and     treatment regimens containing direct-acting antivirals in participants with chronic hepatitis     C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be     collected from participants receiving treatment according to current Summary of Product     Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week     follow-up.   "
140363|NCT01447433|"     The purpose of the study is to determine whether calcium plus vitamin D supplementation is     conducive to weight and fat loss during energy restriction in very-low calcium consumers.   "
140364|NCT01447420|"     This multi-center, open-label study will evaluate the efficacy and safety of Pegasys     (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in     treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys     (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated     time of study treatment is 48 weeks, follow-up is 24 weeks.   "
140365|NCT01447407|"     This partially-blind, placebo controlled study is a Phase 1b study using an investigational     vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will     compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose     level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID)     compared to placebo delivered ID.   "
140366|NCT01447394|"     The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon     Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC)     compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.   "
140367|NCT01447381|"     While many patients with atopic dermatitis (eczema) can be managed with topical creams and     treatments for itch, some children have such severe, long-standing disease that they need     treatment with oral medications that decrease the ability of the immune system to react.     However, there is not enough information on the proper use of these medications or how well     they work compared with each other. The current study looks at the response of children     treated with these medications to provide this information and improve their use.   "
140368|NCT01447368|"     This is a pilot, prospective randomized controlled study with the primary objective to     evaluate and compare medical treatment of SHPT, namely oral cinacalcet versus surgical     treatment, that is, parathyroidectomy with forearm autografting, on the progression of     coronary artery and valvular calcification in endstage renal disease patients over 12 months.     The change in arterial stiffening and bone mineral density as well as nutritional status will     be evaluated as secondary objectives of this study.   "
140369|NCT01447355|"     This pilot phase I trial studies vitamin D levels in the skin of healthy subjects after oral     supplementation. Chemoprevention is the use of certain drugs to keep cancer from forming. The     use of cholecalciferol, a vitamin D, may keep skin cancer from forming.   "
140374|NCT01447290|"     This is a non-inferiority, prospective study of the relationship between the 24-hour urine     protein collection and spot protein:creatinine ratio in the diagnosis of preeclampsia     involving a sample of 18-45 year-old pregnant women attending the new Obstetrics orientation.     The investigators will follow all participants who consent to be part of this study     throughout their entire pregnancy. Those who get evaluated for preeclampsia will then have a     P:C ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine     collection (standard of care). Those participants who are not evaluated for preeclampsia     during their pregnancy will be dropped from the study.      Participants evaluated for preeclampsia during the prenatal period will be asked to provide a     random spot clean-catch urine sample at intervals of approximately 0 and 24 hours following     the initiation of the 24-hour urine collection. The patient's demographic and clinical data,     as well as the spot protein:creatinine ratio and 24-hour urine protein will be collected and     analyzed at the conclusion of the study period.   "
140375|NCT01447277|"     The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block     only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a     decrease in opiate consumption, pain scores, post operative nausea/vomiting, and     post-anesthesia care unit (PACU) length of stay. The investigators are prospectively     randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.   "
140376|NCT01447264|"     The interest in studying the impact of aquatic exercise on muscle strength of patients with     rheumatoid arthritis came after publication of several studies that pointed to the potential     benefit of exercise on the natural history of the disease, including reduction of pain,     better immune response as well as aerobic fitness and functional capacity and increase muscle     strength, endurance and quality of life.      In general, the aquatic exercises are indicated for patients with chronic joint diseases,     since the aquatic environment seems to be more secure for this population due to the     reduction of joint loading, as well as gain range of motion.      However, there are some difficulties to show the real and consistent beneficial effect of     physical activity in these patients, such as the small number of randomized controlled     clinical trials, short intervention period (4-8 weeks), lack of details of the exercise     protocols used, methodological problems (heterogeneous measures to evaluate the outcome,     change of medication). Moreover, no study evaluated the disease activity, according to the     tool most used clinically worldwide, the DAS28.      It is known that aquatic exercises without impact in healthy subjects are sufficient to gain     muscle strength. Nonetheless, in people with joint limitation the benefits from these same     exercises to gain muscle strength is not known.      To date, no studies addressing the effect of aquatic exercise on muscle strength and disease     activity in patients with rheumatoid arthritis. In addition, there is the need to obtain a     standardized protocol for prescribing of aquatic exercises. The choice of lower-limb strength     was based on its relevance to the acceleration and deceleration during the march, as well as     to perform activities of daily living, leisure and professional in these individuals.      Thus, this study aims at:        1. Exercises performed in the aquatic environment and without the concomitant use of          overhead equipment are sufficient to promote gain muscle strength in the lower limb?        2. What is the isolated effect of water resistance on muscle strength? Could it work as an          impact that is used in exercises done on the land?   "
140377|NCT01447251|"     The investigators plan to recruit 140 patients (35 subjects in each group) over a period of     18 months in a prospective study of matched/paired case-control subjects across the four     groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the     5-year risk of developing diabetes will affect continuous positive airway pressure (CPAP)     compliance. The study will have four arms: 1) patients who have newly-diagnosed OSA requiring     CPAP therapy without diabetes and are given the result of the diabetes risk score; 2)     patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not     given the result of the diabetes risk score; 3) age, sex, and BMI-matched controls without     OSA or diabetes; 4) age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA.     The investigators will document that the patients are compliant with CPAP based on review of     SD card data recorded by the CPAP machine. Each patient will have serum drawn for the     biomarker panel as well as the standard diagnostic measures of DM2 (oral glucose tolerance     test (OGTT) upon enrollment in the study. An Epworth Sleepiness Score, BMI, neck and waist     circumference, smoking history, blood pressure, and other standard vital signs will also be     collected.      There will be no follow-up of the study subjects in groups 3 and 4 and their participation in     this study is completed after Visit 1. Groups 1 and 2 will be followed for 6 months after     enrollment to assess whether or not there is any change in CPAP compliance as measured by SD     card.   "
140378|NCT01447238|"     The purpose of this study is to assess the yield of combination modalities in the diagnosis     of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype     needle based confocal laser-induced endomicroscopy miniprobe (nCLE).   "
140379|NCT01447225|"     To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer     therapies   "
140380|NCT01447212|"     The purpose of this study, SALOME, is to determine if 1) the closely supervised provision of     injectable, hydromorphone (HDM; trade name Dilaudid™) is as effective as injectable     diacetylmorphine (DAM; heroin) in the treatment of chronic, multi-morbid opioid-dependent     individuals who have not benefited sufficiently from conventional treatments, and if a switch     to the oral equivalent of hydromorphone and diacetylmorphine is as effective as the injection     form. The availability of an effective, licensed opioid medication such as hydromorphone, for     substitution treatment of chronic, multi-morbid treatment-refractory opioid-dependent     individuals, would be of immense impact locally and internationally. It could help to     establish alternative treatment options where for non-medical reasons Heroin Assisted     Treatment would not be acceptable. Thus, one result could be the expansion of treatment     options for the most difficult to treat heroin dependent persons. This would also be an     important step for secondary prevention of HIV and Hepatitis C as well as a better     integration of those patients in other medical treatments. Switching from intravenous to oral     application would also reduce a lot of potential risk factors (like overdose, seizures,     infections, etc) and side effects associated with the injection route. Additionally it could     make these treatments more feasible in normal treatment settings, like existing methadone     services.   "
140381|NCT01447199|"     The goal of this study is to understand factors which may influence risk for colorectal and     other cancers in families. These factors include genetic variability, in combination with     diet and lifestyle. In order to achieve these goals, we need to contact as many eligible     participants as possible.   "
140436|NCT01446471|"     The aim of this study is to investigate the predictive value of the presence or absence of     cardiac activity by bedside ultrasound during cardiac arrest. The investigators anticipate     based on previous research that patients who suffer a cardiac arrest and have cardiac     activity on bedside ultrasound will have a greater chance of surviving to hospital admission.     The investigators hypothesis is that the mortality rate in patients in cardiac arrest with no     cardiac activity by ultrasound will have a mortality rate of 100%.   "
140382|NCT01447186|"     Objectives:      The primary objective of this project is to develop and evaluate a Spanish-language slide set     for administration in group settings, adapted from the content of the current guidelines and     existing, self-administered ACS early detection decision aid.      A guide for educators will accompany the slide set so that materials may be distributed on a     broad scale at the completion of the project. It is expected that these products will be made     available to community-based educators and screening programs to be used in support of an IDM     process for early detection of prostate cancer with Spanish-speaking men.      Specific Aims:      To conduct an extensive review of the literature and other resources to identify themes     related to early detection, concerns and beliefs about prostate cancer in Hispanic men.     Findings will be used to adapt the slideset.      To cognitive test the Spanish-language decision aid slide set with Hispanic men To conduct     focus groups to evaluate the acceptability of the adapted slide set with Spanish-speaking     Hispanic men who are candidates for prostate cancer screening. Participants will be tested     for their knowledge of prostate cancer and acceptability of materials (e.g. length, clarity,     amount and balance of information provided).   "
140383|NCT01447173|"     The study looks at how vitamin D supplement will improve the severity of asthma and lung     function as well as biomarkers in asthmatic children.   "
140384|NCT01447160|"     The purpose of this study is to evaluate the effectiveness of facet joint infiltration with     corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.   "
140385|NCT01447147|"     The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B     in subjects with diabetic nephropathy.   "
140386|NCT01447134|"     1. Primary endpoint(s): To determine the relationship between the drug distribution and          angiogenesis in head and neck cancer patients.        2. Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate          the parameters from the image study to clinical treatment response and prognosis.   "
140387|NCT01447121|"     This clinical trial is designed to assess an investigational blood glucose monitoring system     with fingerstick blood in the hands of untrained intended users.   "
140388|NCT01447108|"     The Suicide Disease, Trigeminal Neuralgia (TN) is arguably caused by one of the most     discrete and eloquently reversible central nervous system lesions known to the field of     neurology.      Recently Dr Adahan H. and Dr Binshtok A. have completed an open label series of 25 subjects     with refractory TN showing a remarkable positive response rate to TN's treatment with Low     Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU).      The primary objective of this study, therefore, is to determine whether this apparent     efficacy of Low Intensity Low Frequency Ultrasound (LILFU) in the treatment of TN pain could     withstand the rigors of an n=1 crossover placebo control study.      Participants with refractory trigeminal neuralgia pain despite optimized pharmacotherapy for     at least six months will be screened for participation in the study based on rigorous     inclusion and exclusion criteria. It is judged rather unlikely that such subjects will     experience spontaneous regression of their disease in the course of this study.      Patients meeting the inclusion criteria will be treated with four weeks of a placebo Low     Intensity Low Frequency Surface Acoustic Wave Ultrasound (LILF/SAWU) device while continuing     with their pharmaco-analgesic regimen. All patients will be crossed over to active LILF/SAWU     therapy for the next four weeks. Patients will be blinded to all treatments throughout the     study. Patients will be instructed to use the device daily overnight, and remove it upon     wakening. The device is programmed to work in cycles of 30 minutes on and 30 minutes off, for     a total of six- eight hours of intermittent treatment.      At the end of the second month of the study, patients will be offered a choice as to whether     they wished to continue with the current (active) device or go back to the 1st (sham) device.      Patient's pain severity will be tracked every two weeks over the course of three months.     Functional health and well being will be monitored at intake, post Placebo period, post     Active period and at completion of the study.   "
140389|NCT01447095|"     The purpose of this study is to determine whether prostacyclin is effective in prevention of     cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).   "
140390|NCT01447082|"     The main objective of this observational study is to characterize new users of quetiapine XR     as well as new users of other study drugs (i.e. the comparison group) and to quantify the     risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well     as in other study drugs.   "
140391|NCT01447069|"     The purpose of this study is to determine whether Salbutamol is effective in the treatment of     severe heart failure due to ischemic and non- ischemic cardiomyopathy.   "
140392|NCT01447056|"     Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages     called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called     leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The     disease has come back, may come back or has not gone away after treatment. This voluntary     research study uses special immune system cells called LMP-specific cytotoxic T lymphocytes,     a new experimental therapy.      Some patients with these diseases show evidence of infection with the virus that causes     infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their     diagnosis. EBV is found in the cancer cells of up to half of the patients with lymphomas, and     in some cases of NPC and LMS, suggesting that it may play a role in causing these diseases.     Those cancer cells (as well as some B cells in SCAEBV) that are infected by EBV are able to     hide from the body's immune system and escape destruction. We want to see if special white     blood cells, called T cells, that have been trained to kill cells infected by EBV can survive     in the blood and affect the tumor.      This treatment with specially trained T cells has had activity against these viruses when the     cells are made from patients with those diseases (or, after bone marrow transplant, from the     patient's transplant donor). However, sometimes it is not possible to grow these cells; other     times, it may take 2 to 3 months to make the cells, which may be too long when one has an     active tumor. We are therefore asking if subjects would like to participate in this study,     which tests if blood cells from a donor that is a partial match with the subject (or the     transplant donor) that have been grown in the way described above can survive in the blood     and affect the disease.      These LMP-specific CTLs are an investigational product not approved by the Food and Drug     Administration.   "
140393|NCT01447043|"     Retrospective, non-interventional, observational multi-center field study. Patients diagnosed     with wet Age-related macular degeneration (wAMD) and having started treatment with     ranibizumab between January 1, 2009 and August 31, 2009 must be consecutively screened and,     if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch     to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be documented     and followed up. For each patient, demographics, medical history, administered treatments,     results of ocular and visual assessments and other tests (where available) will be     documented.   "
140394|NCT01447030|"     Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication     with major implications for patient outcome. For most major BDIs, the recommended method of     repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish     hepatobiliary centres aiming to examine the perioperative and the long-term outcome after     reconstructive HJ.   "
140395|NCT01447017|"     The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear     drops compared to placebo for DPK-060 ear drops in patients with acute external otitis. The     secondary objectives are to evaluate clinical cure and microbiological growth following     treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.   "
140397|NCT01446991|"     This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing     Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate     brachytherapy. There are 2 eligible populations of men, all of whom will have selected     brachytherapy as their treatment of choice for their prostate cancer. Either they have an     enlarged prostate that requires size reduction to render brachytherapy technically feasible,     or they require androgen ablation in conjunction with brachytherapy for optimal tumor     control. The hypothesis is that Degarelix will provide > 30% volume reduction by 3 months in     > 30% of men.   "
140398|NCT01446978|"     Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability     to induce protective immunity in immunosuppressed travelers are scarce. The investigators     assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis     (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).      In a previous study, 2 doses were not considered effective and there is therefore need for a     study with an additional dose   "
140399|NCT01446965|"     This study explores the hypothesis that wearable defibrillators can impact mortality by     reducing sudden death during the first three months after a heart attack in persons with high     risk for life-threatening arrhythmias.   "
140400|NCT01446952|"     This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol     in subjects with resectable pancreatic tumors.   "
140401|NCT01446939|"     Parkinson´s disease (PD) diagnosis is based upon clinical examination. Although imaging has     helped doctors to identify many diseases, it still does not add too much information for the     diagnosis of Parkinson´s disease. The investigators are going to perform a large sample study     including PD patients, essential tremor and healthy volunteers in order to evaluate if MRI     can help in the diagnosis. Our hypothesis is that fractional anisotropy (FA) in the caudal     portion of substantia nigra is decreased in PD patients.   "
140402|NCT01446926|"     This study is designed to explore the safety and tolerability of an investigational     pneumococcal vaccine through a step-down enrollment.      Primary Objective:        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.      Secondary Objective:        -  To evaluate the immunogenicity of an investigational pneumococcal vaccine.   "
140403|NCT01446913|"     The goal of this study is to develop a novel study design to safely and ethically conduct a     long-term randomized controlled trial among patients at high risk for both sleep apnea and     cardiovascular events that will examine whether effective positive airway pressure(PAP)     therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke     have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular     events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular     death)in the first year post event, despite current prevent strategies. Therefore, the     treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular     outcomes in this high risk population.   "
140404|NCT01446900|"     The objective of this study is to confirm the efficacy of the association of R-2cda in     patients affected by Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma and of     evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab     alone in increasing and prolonging the duration of the response.   "
140405|NCT01446887|"     Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It     remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A     randomized double-blind study was conducted to determine whether prophylactic anticoagulation     was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to     prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were     followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator     also used logistic regression analysis with variable selection for obtaining the prediction     model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical     compression, duration of surgery). THA with short duration of surgery did not require     prophylactic anticoagulation.   "
140406|NCT01446874|"     Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It     leads to considerable morbidity and contributes to perioperative morbidity. There is evidence     in literature that supports the use of strategies for improved oral hygiene and specialized     endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically     ventilated patients. This study aims at utilizing a combination of these interventions in the     perioperative period in patients undergoing planned thoracic surgical procedures.   "
140407|NCT01446861|"     Purpose The purpose of this study is to develop and validate multimodal testing of exocrine     pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in     patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be     correlated to age group, genotype, nutritional status and quality of life. Earlier detection     of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of     therapeutically benefit.      Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine     pancreatic function in patients with cystic fibrosis.      New functional testing of exocrine pancreatic function is superior to traditional testing     with fecal elastase.      MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.      Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and     parenchymal changes in cystic fibrosis patients.      Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and     development of hepatocellular carcinoma in the liver of cystic fibrosis patients.      Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in     duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with     exocrine pancreatic function.   "
140408|NCT01446848|"     The purpose of this study is to investigate the effects of iron supplementation in patients     with pulmonary arterial hypertension and iron deficiency.   "
140409|NCT01446835|"     The purpose of this study is to compare the cosmetic appearance of two different contact     lenses on Asian eyes.   "
140688|NCT01443013|"     This observational study is designed to analyse the urinary mRNA expression of Foxp3 and     Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant     recipients from 17 renal transplant site in France and to determine the predictive value of     these gene expression on the one year graft outcome including graft function, one-year graft     histological analysis and incidence of acute rejection.   "
140410|NCT01446822|"     This is a single-center, prospective, randomized, controlled trial comparing two established     transurethral electrical resection methods of urinary bladder tumors regarding their risk of     stimulating the obturator nerve.      One of the major safety issues with transurethral resection is bladder perforation as a     consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly     a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. It     has been advocated that bipolar may be superior to monopolar resection, based on its     different electrical properties. This is an important safety aspect for the patient.      Main study question: In patients with lateral wall urinary bladder tumors, is bipolar     superior to monopolar transurethral electroresection regarding risk of stimulation of the     obturator nerve without preoperative nerve block?   "
140411|NCT01446809|"     This randomized pilot clinical trial studies pazopanib hydrochloride followed by chemotherapy     and surgery in treating patients with soft tissue sarcoma. Pazopanib hydrochloride may stop     the growth of tumor cells by blocking some of the enzymes that are needed for cell growth and     may also stop the growth of soft tissue sarcoma by blocking blood flow to the tumor. Giving     pazopanib hydrochloride and chemotherapy before surgery may make the tumor smaller and reduce     the amount of tissue that needs to be removed.   "
140412|NCT01446796|"     Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left     ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart     failure. However, little is known about RV pacing in patients with advanced heart failure     treated with an implantable left ventricular assist device (LVAD). The univentricular support     provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart     failure patients, yet the incidence of RV failure in the early post-operative period     following implantation is associated with significantly reduced survival and increased length     of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size     that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing     may counteract these adverse mechanical alterations, improving RV systolic function and     ultimately LVAD function.      The investigators will recruit all patients referred for an implantable, continuous flow LVAD     at Duke University Medical Center who have an existing implantable dual-chamber     cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to     compare continuous right ventricular pacing vs. native ventricular conduction at equivalent     heart rates. Multiple clinical outcomes will be examined over a two week period     post-operatively including invasive hemodynamics, vasoactive medication use, end-organ     function, RV function by Echocardiography as well as patient symptoms and functional status.   "
140413|NCT01446783|"     The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella tendon     of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen     synthesis. Furthermore collagen synthesis is measured in muscle connective tissue and in     skin.      The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and     poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by     IGF-I.   "
140414|NCT01446770|"     The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a     hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated     with keloid scarring in subjects undergoing surgical revision of keloid scars.   "
140415|NCT01446757|"     The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric     Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes     such as health and health-related quality of life among both patients and relatives, feeling     of safety among both patients and relatives and reduce costs, compared with usual care.   "
140416|NCT01446744|"     Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers     high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique     can potentially allow radiation treatments to be focused more precisely, and delivered more     accurately than with older treatments. This improvement could help by reducing side effects     and by improving the chance of controlling the cancer by more precisely treating the cancer.     The purpose of this study is to compare SABR with current approaches of chemotherapy and     conventional radiotherapy to assess the impact on overall survival and quality of life.   "
140417|NCT01446731|"     This is a randomized phase II trial including 40 patients with castration resistant     metastatic cancer prostate (CRMPC).      Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel     and docetaxel alone.      The primary objective is to evaluate the vaccine specific immune response and patients will     be evlauated with blood tests and DTH reactions during the treatment course.      Secondary objectives are to evaluate clinical response by objective response     (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine     time to progression and overall survival.   "
140418|NCT01446718|"     The purpose of this study is to determine sustained immunogenicity of the quadrivalent     vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls     age 9-14 years. This age range is within the World Health Organization (WHO) stipulated     guidelines for national programs for the vaccine.   "
140437|NCT01446458|"     The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and     Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic     cancer is safe and well tolerated. This study will obtain preliminary data on the response of     the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer     after it is resected surgically.      In addition, the investigators will perform biochemical studies on the tumor tissue obtained     from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure     the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important in     the behavior of pancreatic cancer cells.      The data obtained from this trial will be extremely valuable to help improve the approach to     treating pancreatic cancer in the future. If you do not undergo surgery after completion of     FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under computer     tomography (CT) -guidance in order to measure the effect of treatment on your tumor.   "
140689|NCT01443000|"     The purpose of this study is to characterise the clinical features, histopathology and the     treatment outcomes of patients with idiopathic orbital inflammation syndrome.   "
140419|NCT01446705|"     Three out of four Veterans receive a portion of their care from non-VA providers. On April 9,     2009, President Barack Obama directed the Department of Veterans Affairs and the Department     of Defense to create the Virtual Lifetime Electronic Record (VLER). On August 2010, Secretary     of Veterans Affairs Eric K. Shinseki visited Indianapolis, and after visiting with leaders     from the VA Health Services Research & Development (HSR&D) Center of Excellence and the     Regenstrief Institute, he made the following public comments regarding the latest partnership     between the two institutions: This new technology allows safer, more secure, and private     access to electronic health information which, in turn, enhances our ability to continue     providing Veterans with the quality care that they have earned.      This new technology refers to the VLER HEALTH program that the Indianapolis VA is now     implementing in partnership with the Regenstrief Institute and Indiana Health Information     Exchange (IHIE). This VA-IHIE demonstration project is intended to create the capacity for VA     institutions to exchange health information with community partners.      Investigators from the VA HSR&D Center on Implementing Evidence-Based Practice are active     collaborators in building and implementing this program. The VA-IHIE program provides the     bi-directional exchange of health information between VA and non-VA providers. Based on our     pilot study of linked VA-IHIE data, investigators are conducting an evaluation of the impact     of the VA-IHIE demonstration project upon health care quality and cost of Veterans by taking     advantage of the initiation of the implementation as a natural experiment.   "
140420|NCT01446692|"     A retrospective study using a data base of anonymized medical records. The purpose of the     study is to examine the different therapeutic strategies for the management of patients with     major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary     care   "
140421|NCT01446679|"     This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve     the category-specific targeted lipid levels.   "
140422|NCT01446666|"     Current practice guidelines recommend surveillance for hepatocellular carcinoma (HCC) in     liver cirrhosis patients with ultrasonography (USG) every 6 months. However, with the     advancement of cirrhosis, the sensitivity of USG decreases, while the risk for HCC increases.     Gadoxetic acid (Primovist®)-enhanced magnetic resonance imaging (MRI) has been demonstrated     to be of clinical value for diagnosis of HCC with the detection sensitivity of 90-95%, which     is significantly higher than USG. The hypothesis to be proved by this study is as follows;     Primovist-MRI should show significantly higher sensitivity compared to USG for the detection     of early stage HCC when both of these imaging modalities are used with the interval of 6     months in patients with cirrhosis at high risk of developing HCC.   "
140423|NCT01446653|"     The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive     intervention against one comparison and one control condition. Because prevention of     Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR     contraception, the primary endpoints will be rates of risky drinking and ineffective     contraception at six-month follow-up, in addition to dichotomously defined successful     outcome that will be observed whenever a woman has sufficiently altered one or both of the     behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify     a transferable intervention that effectively reduces behaviors that put women at risk for AEP     and alcohol-related birth defects including FASD.   "
140424|NCT01446640|"     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous     combined with intrathecal administration of autologous bone marrow derived mesenchymal stem     cells to patients with spinal cord injury.   "
140425|NCT01446627|"     The purpose of this study is to evaluate the incidence of wound breakdown or wound infection     following skin closure with Insorb subcuticular absorbable staples versus metal staples after     cesarean section through a retrospective chart analysis.   "
140426|NCT01446614|"     The study is a phase I/II trial designed to establish the safety and efficacy of intravenous     administration of autologous bone marrow derived mesenchymal stem cells to patients with     Parkinson's disease.   "
140427|NCT01446601|"     The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve     stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential     therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that     have failed or do not tolerate positive airway pressure (PAP) therapy.   "
140428|NCT01446588|"     The investigators aim to pilot test the efficacy of a yoga intervention designed specifically     for individuals with ocular hypertension. The investigators would like to find out if a     combination of breathing, postures and meditation may help to reduce intraocular pressure in     the short term after each yoga session, and also long-term across an 8-week program. Subjects     will participate in the yoga intervention sessions led by Dr. Pamela Jeter once a week at the     investigators center, and will be asked to practice at home at least twice a week using a     audio CD.   "
140429|NCT01446562|"     The primary objective of this study is to establish in a prospective phase II study the     efficacy of 90Yttrium ibritumomab tiuxetan (90Y-RIT) after first line induction     immuno-chemotherapy with R-CHOP in patients with high-risk advanced stage follicular     non-Hodgkin's lymphoma, as assessed by the complete response rate.   "
140430|NCT01446549|"     The purpose of this study is (1) to provide quantitative information of the motor     manifestations of Parkinson's disease and (2) to quantify the effect of high intensive     antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's     disease.   "
140431|NCT01446536|"     Hypothesis: Quality Improvement tools like Heart Failure Discharge Checklist which     emphasizes on proper education to patients, ensure appropriate dose titration and counselling     improve outcome in congestive heart failure (CHF).   "
140432|NCT01446523|"     The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic     Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal     hepatic encephalopathy.   "
140433|NCT01446510|"     A systematic review and meta analysis will be performed of risk assessment models for Venous     thromboembolism (VTE including pulmonary embolism PE and deep venous thrombosis DVT)in     hospitalized medical patients. The goal of this study is to evaluate whether the incidence of     VTE is lower in patients that are evaluated with a risk assessment model and treated with     thromboprophylaxis for their assigned level of risk.   "
140438|NCT01446445|"     The objective of the present study is to optimize intravenous ganciclovir(GCV) and oral     valganciclovir (VGCV)doses, advised by the drug exposure, indicated by the area under the     concentration time curve (AUC), in renal transplant patients receiving oral VGCV or     intravenous GCV for CMV prophylaxis or treatment. The initial doses will be calculated     according to population pharmacokinetic model. Subsequent doses will be adjusted according to     plasma GCV concentrations, using the Bayesian approach. This method of dose adjustments could     lead to increase the percentage of patients achieving a therapeutic exposure.   "
140439|NCT01446432|"     A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective     is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are     standard and validated questionnaire instruments used to measure health related quality of     life and function, they do not address patient specific issues. The investigators will also     pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's     Disease.   "
140440|NCT01446419|"     To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve     Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain.     This is a prospective, double-blind, randomized, sham-controlled clinical trial with an     optional crossover component.   "
140441|NCT01446406|"     Bipolar disorder is associated with a high risk of relapse and hospitalisation and many     patients do not recover to previous psychosocial function. Major reasons for poor outcome are     delayed intervention for prodromal depressive and manic episodes as well as decreased     adherence with treatment. Recently, electronic self monitoring of affective symptoms using     cell phones to prompt patients to respond to weekly text messages has been suggested as an     easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the     electronic devises has been rather simple not including a bi-directional feed back loop     between patients and providers and without electronic data on objective measures of the     affective psychopathology. As part of an ongoing EU research program a software program for     online electronic self-monitoring using a cell phone is being developed including an     interactive feed back loop between patients, relatives and clinicians. Electronic     self-monitoring includes subjective items such as mood, irritability, sleep duration,     activity, alcohol consumption, medication intake and objective items of speech duration (on     the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and physical     activity (acceleration of the cell phone). The present PhD. study will in a randomized     controlled single blind trial including 60 patients with bipolar disorder allocated to using     the active cell phone program (intervention group) or to using a cell phone to usual     communication (control group) during a 6 months study period.      If the cell phone self-monitoring system is proved effective in preventing mood symptoms and     improving psychosocial functioning,quality of life etc. in the present study there might be     basis for extending the use of the system to treatment of patients with bipolar disorder in     clinical practice in general.   "
140442|NCT01446393|"     To determine the specific structural and functional features of the peripheral arteriopathy     in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.   "
140443|NCT01446380|"     The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum     (PXE) disease in various tissues (eye, skin, arteries, etc).   "
140444|NCT01446367|"     The purpose of this study is to evaluate the corneal changes after performing 20 gauge     vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal     detachment.   "
140445|NCT01446354|"     Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative     transfusion of allogeneic blood products which is associated with increased morbidity and     mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of a     thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line     hemostatic agent on the perioperative use of allogeneic blood products.   "
140446|NCT01446341|"     Acute, severe lateral ankle sprains are estimated to comprise between 3-5% of emergency     department visits and are the most common musculoskeletal injury in the physically active     population. Although the current accepted treatment of ankle sprains is to encourage early     mobilization with functional rehabilitation, there is little high-quality evidence directing     this clinical practice.      This pilot study is to:        -  provide quantitative data for estimation of mean outcome scores and standard deviations          to allow subsequent sample size calculations        -  evaluate the feasibility of the proposed study design        -  assess patient enrollment issues specific to randomization into an active rehabilitation          program compared to below knee immobilization.   "
140447|NCT01446328|"     In the Bergen Psychosis Project 2 the antipsychotic drugs aripiprazole, amisulpride, and     olanzapine will be compared head-to-head in patients with schizophrenia and related psychoses     and followed for 12 months. The study is independent of the pharmaceutical industry, and in     accordance with a pragmatic design a clinically relevant sample will be included with as few     exclusion criteria as possible. The patients will be assessed repeatedly with regards to     symptoms, side effects, and cognitive functioning, as well as laboratory parameters. The     study hypothesis is that clinically meaningful differences among the drugs will be disclosed     in a pragmatic design.   "
140448|NCT01446315|"     Asthma is a common problem among US adults and children. Unfortunately many people with     asthma continue to suffer from asthma symptoms that could be control with better asthma care     and more attention to details such as triggers, and adherence. To date the only tools     available and recommended by groups such as the national asthma guideline group consider only     asthma burden and do not include information on the most common factors that adversely affect     asthma control. This study provides one half of the enrolled primary care offices with the     Asthma APGAR which is a system of patient completed questions and a care flow sheet. The     other half of the enrolled practices will continue to provide usual care without the     support of the Asthma APGAR system. The research questions is whether or not asthma control     and asthma related quality of life will be improved in people with asthma who are cared for     in the intervention practices that use the Asthma APGAR system.   "
140449|NCT01446302|"     The objective of this study is to characterize the hormonal and inflammatory responses to     hemodialysis, and to determine the effect of a meal versus fast on the metabolic changes in     the post-dialytic phase.   "
140450|NCT01446289|"     The study investigated the immune response induced by the Group B streptococcus vaccine in     healthy pregnant women. In addition, the study investigated the amount of vaccine induced     antibodies which were transferred to the newborn.   "
140474|NCT01445977|"     This study is designed to collect data about the SoundBite™ Hearing System to answer specific     questions. The hearing system has been cleared for commercial distribution by the Food and     Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what features     and settings of this device provide the best hearing ability for people diagnosed with Single     Sided Deafness (SSD) or Conductive Hearing Loss (CHL).   "
140451|NCT01446276|"     The purpose of this study is to investigate potential metabolic effects of resveratrol in     obese healthy men with non-alcoholic fatty liver disease.      The investigators hypothesize that resveratrol will:        -  decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion        -  decrease liver fat content        -  increase insulin sensitivity      The investigators will look at changes in:        -  lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)        -  liver fat content (MR liver spectroscopy)        -  insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)        -  body composition (DXA and MRI)        -  lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)   "
140452|NCT01446263|"     Increased use of radial access for cardiac catheterization is being advocated because studies     have showed lower arterial access related complication rates and higher patient satisfaction     as compared to femoral access. However, little is known on patients with prior coronary     artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed     to test the hypothesis that bypass graft angiography and intervention via radial access     provides lower vascular complication rates, similar contrast and equipment utilization and     higher patient satisfaction when compared with transfemoral approach.   "
140453|NCT01446250|"     This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC),     each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American     participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1     infection.   "
140454|NCT01446237|"     This study is being conducted to obtain safety, efficacy, and satisfaction data on the     combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent     Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate     or severe acne will be asked to apply the commercially available, over-the-counter products     Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating     Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.   "
140455|NCT01446224|"     This observational study is conducted as part of a systematic pharmacovigilance activity, to     provide a population-based context for Pazopanib use outside of the clinical trial setting.     The aims of the study are to examine the incidence of cardiovascular ischemia (including     myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular     accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients     treated with marketed anti-VEGF agents [Pazopanib (VOTRIENT), Bevacizumab (AVASTIN),     Sorafenib (NEXAVAR), and Sunitinib (SUTENT)].      Two databases will be utilized for this study: a large healthcare claims database in the U.S.     and the Dutch linked medical registries (PHARMO RLS). The databases will provide large,     geographically varied, non-trial populations in which to examine the incidence of the stated     cardiovascular ischemic events and Torsades des Pointes.   "
140456|NCT01446211|"     The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared     to conventional treatment in patients with a relapse of Wegener Granulomatosis with or     without ongoing steroids, and/or immunosuppressive therapy. Further, to evaluate the safety     and quality of life of gusperimus treatment compared to standard treatment in patients with     relapse of Wegener Granulomatosis receiving glucocorticoids.   "
140457|NCT01446198|"     The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is     comparable to performance on the TIGRIS System.   "
140458|NCT01446185|"     Primary objective:      Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation     made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or     pN1(mi), Her2- breast cancer adjuvant population.      The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment     intensity defined as a change in treatment recommendation from chemotherapy plus hormonal     therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement     from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.      Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast     cancers. These are usually good prognosis tumors. However, on the basis of classical clinical     and pathological prognostic parameters and markers, the international consensus guidelines     recommend treatment with hormone- and chemotherapy in 85-95% of the cases. Considering the     natural disease history, such as documented by the EBCTCG meta-analysis, more than 50% of     these patients are overtreated, which leads to unnecessary side effects and costs to the     health system and to the society.      Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N-     patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best     adapted to daily clinical practice as it does not necessitate any specific surgical procedure     or tissue freezing.      The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on     three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The test     has been commercially available in the USA since 2004, and is being used for more than 50% of     the HR+ N- patients in this country.      While Oncotype DX has been validated in the USA, it needs to be independently evaluated in     France, in the context of the local treatment guidelines and habits, to provide data that are     meaningful to the French health system and to the French medical community.   "
140459|NCT01446172|"     While cognitive therapy and exposure therapy are both proven to be effective for panic     disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould     et al., 1995) the scientific knowledge about long-term course of these disorders is still     scanty. Although several long-term outcome studies have been conducted, the quality of these     studies has been questioned.      The aim is to conduct a follow-up study of patients with either panic disorder with history     of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in     a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included     in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive     and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were     allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients     treated in 1994 - 1996) received cognitive and schema focused therapy.      In the follow-up study the participants will be requested to complete the same self report     measures as they completed at intake, discharge and at previous follow-up times. the     participants will also be interviewed using the SCID-I and II as they were at the previous     assessments.      The present sample is relatively unique in having received pure psychosocial experimental     treatments. The very long term efficacy of cognitive therapy relative to behavioural     treatmetns for agoraphobia can be evaluated, and the potential moderating effects of     personality disorders can be assessed.   "
140460|NCT01446159|"     Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573     in combination with an AI in adult subjects with HR+, HER2-negative MBC.   "
140461|NCT01446146|"     The purpose of this program is to compare two different methods of matching a Veteran to a     PTSD treatment.   "
140462|NCT01446133|"     The goal of this clinical research study is to learn if the combination of lenalidomide and     rituximab can help to control CLL. The safety of this drug combination will also be studied.      Lenalidomide is designed to change the body's immune system. It may also interfere with the     development of tiny blood vessels that help support tumor growth. This may decrease the     growth of cancer cells.      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to     die.   "
140463|NCT01446120|"     This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved     Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick     (buccal) , Releasing the insulin to the circulation, while the film is dissolved..      Primary endpoint:        1. The Cmax (Maximum Concentration of insulin in mg).        2. Tmax (the time to Cmax in minutes)        3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.      Secondary endpoints:        1. The glucose and C-peptide levels during six hours of the trial. (mg)        2. The safety of the treatment in a descriptive manner by recording all adverse events in          the study population.      Methods      Seven healthy volunteers will be randomly assigned to one of the following groups:      A. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.      The study is designed a crossover, in which each group is treated 3-7 days of washout.      The volunteer subjects will arrive to the clinic after eight hours fasting. Each subject will     be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion and     exclusion criteria).      An I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels,     ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.      Blood Insulin and glucose levels will be evaluated at baseline, and after the following time     points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be     evaluated at baseline and after the following time points: 60,120,240, 360 minutes.   "
140464|NCT01446107|"     Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of     the lesions are in the fissures of the first permanent molars. This study aims to investigate     the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese     children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride     solution. The cost-effectiveness of these methods will also be compared. About 400 children,     aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted     in school using portable dental lights and instruments to identify teeth that need caries     prevention. The children will be randomly allocated to one of the three test or the control     groups. Treatments will be provided in the study primary schools according to standard     clinical protocols. Follow-up examinations will be carried out every six months for 30 months     to assess whether the preventive methods are successful, i.e. no dental caries develops in     the treated teeth. The findings of this study will be of great value to dentists and public     health authorities in deciding on the most appropriate dental caries prevention programme for     school children in China and other developing countries.   "
140465|NCT01446094|"     This study is designed to evaluate the feasibility and diagnostic performance of a novel     rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.   "
140466|NCT01446081|"     Reduced quality of life, fatigue, and loss of physical function are common in patients     getting chemotherapy for acute myeloid leukaemia (AML). The investigators completed a pilot     study showing that exercise during active chemotherapy for AML is feasible, safe, and may     improve symptoms and physical function. The investigators now propose to compare our     hospital-based supervised exercise program to usual care to see if exercise can improve     symptoms, physical function, and improve treatment tolerability.   "
140467|NCT01446068|"     The purpose of this study is to quantify the systemic inflammatory and metabolic response of     lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.   "
140468|NCT01446055|"     Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb     ischemia has been proved safe and effective. However, processing bone marrow by Ficoll     density gradient centrifugation is not only time consuming but also expensive. Manually     processing of bone marrow also results in large variation in therapeutic cell quantity and     quality which directly leads deviation of safety and efficacy of the cell therapy. This study     is aiming to compare an automated bone marrow processing system with a conventional manual     method in term of safety and efficacy.   "
140469|NCT01446042|"     The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile     of testosterone) and safety of TBS-1 in the treatment of hypogonadal men   "
140470|NCT01446029|"     The purpose of this study is to determine if the adoption of a chronic care model in     conjunction with tele monitoring and case management can reduce the risk of death,     hospitalization, emergency room visits, or admission to a skilled nursing facility in     patients with chronic kidney disease compared to usual care.   "
140471|NCT01446016|"     The major purpose of this research study is to better understand how therapy works on     different patients. This study is being offered to patients with a diagnosis of advanced or     metastatic breast cancer who have failed anthracycline based therapy.      The investigators want to see the response of breast cancer cell when treated with     Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that     is given through your vein. The chemotherapy used in this study is either Taxane (Paclitaxel)     or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel).   "
140472|NCT01446003|"     This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic     blood pressure in participants with mild to moderate hypertension in addition to safety and     tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure     to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood     pressure change from baseline after 10 days of dosing.   "
140473|NCT01445990|"     Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments     diagnosis in free tissue transfers is realized.      These measures are done after surgical reconstructions with free tissue flap, simultaneously     with clinical examination. These biological data aren't available to make clinical diagnosis     of complication; only clinical examination is allowed in this way.      A posteriori, clinical and biological parameters will be compared in order to determine if     capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps     monitoring.   "
140477|NCT01445938|"     Primary Objective:      To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite     reduction ratio at 72 hours in pediatric patients with uncomplicated malaria      Secondary Objectives:        -  To assess the evolution of clinical signs and symptoms (including the need for a rescue          therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with          reference to Artemisinin-Based Combination Therapy (ACTs)        -  To assess the pharmacokinetics profile of SAR97276A in pediatric patients with          uncomplicated malaria        -  To assess the safety profile of SAR97276A in pediatric patients with uncomplicated          malaria        -  To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A   "
140478|NCT01445925|"     The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by     radiofrequency ablation would improve single procedure success rates for Radio Frequency     Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term     peri-procedural anti-arrhythmic drug therapy alone.   "
140479|NCT01445899|"     This is a two-part study. The first part (Stratum I) is an open-label, dose escalation,     safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be     given to all patients who participate. Stratum I will determine the maximum tolerated dose     and any dose-limiting toxicities. The second part (Stratum II) is a prospectively randomized,     multi-center, double-masked, dose ranging study evaluating the efficacy and safety of     PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients     with DME.   "
140480|NCT01445886|"     The purpose of this study is to compare the efficacy and safety of indigo naturalis oil     extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo     naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an     effective alternative for those who do not respond well to traditional therapy.   "
140481|NCT01445873|"     The objectives of this study are to develop research methods and corresponding materials for     a study of the effectiveness of sitaxentan sodium (Thelin) in real-world settings; to pilot     test these methods at three study centers in Europe; and to refine and finalize research     methods and corresponding materials for possible use in a follow-on, full-scale examination     of the effectiveness of sitaxentan sodium (Thelin) in real-world settings.   "
140482|NCT01445860|"     The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on     the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.   "
140483|NCT01445847|"     In the literature, we found no randomized clinical trials addressing the using of IV     lidocaine as prophylaxis for postoperative laryngospasm among adults.      The aim of this study was to assess the effects of IV lidocaine on the incidence of     postoperative laryngospasm of adults patients.   "
140484|NCT01445834|"     In this retrospective study the outcome of pelvic floor muscle training in 150 women will be     tested regarding patients reported satisfaction and achievement of the incontinence     improvement.      Comparison of two age groups, controlled for BMI, parity and previous incontinence     operations.   "
140485|NCT01445821|"     ASSIST I was the first randomized trial in patients with scleroderma to not just slow disease     progression but rather actually reverse it. It is the first treatment to have ever     demonstrated reversal of lung disease in scleroderma with improvement in FVC, total lung     capacity (TLC), high-resolution computed tomography (HRCT), and QOL. We now, therefore,     purpose to compare the ASSIST I conditioning regimen of cyclophosphamide and rATG to a less     intense regimen of rATG/cyclophosphamide/Fludarabine. In the new regimen the cyclophosphamide     dose is decreased to 120mg/kg (60mg/kg/day x 2) compared to 200mg/kg (50mg/kg/day) in the     standard regimen. The lower dose of cyclophosphamide will be less cardiotoxic. This study     will determine if the less cardiotoxic regimen will be safer than the standard regimen and as     effective as the standard regimen.   "
140486|NCT01445808|"     The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and     Training Program (PMT) for the improvement of physical fitness in patients with stable     coronary heart disease as compared to advice in exercise training or treatment as usual.   "
140487|NCT01445795|"     This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of     INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a     study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV),     Treatment-naïve subjects.   "
140488|NCT01445782|"     This study will investigate the safety and tolerability of AZD2115 following administration     of multiple ascending doses.   "
140489|NCT01445769|"     The purpose of this study was to evaluate the effect of an alternative dosing strategy of     ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia     vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF) in     order to minimize the development of anemia and thrombocytopenia.   "
140490|NCT01445756|"     Intrauterine contraception is a very effective, long term, reversible form of birth control,     and is increasingly used in young, nulliparous patients. However, there is potential for pain     with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous     history of vaginal delivery. The potential pain associated with insertion is often a     significant barrier for patients when choosing and IUD for contraception. Several methods of     pain control have been studied, but none have been shown to reduce pain at time of insertion.     Our research question is to determine if 2% topical lidocaine gel, instilled into the     cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena     Intrauterine System) in young, nulliparous patients. This will be studied in a randomized,     double-blind placebo-controlled trial.   "
140491|NCT01445743|"     That is a double-blind randomized trial with parallel control to demonstrate the safety and     immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is     to determine the safety and immunogenicity of acellular Tdap vaccine.      The experimental group will receive acellular Tdap vaccine and the control group will receive     a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will     be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the     vaccine.   "
140690|NCT01442987|"     The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and     Atorvastatin in patients with hypertension and hyperlipidemia.   "
140492|NCT01445730|"     High fructose intake is increasingly recognized as causative in development of prediabetes,     metabolic syndrome and cardiovascular disease (CVD). The mechanisms underlying     fructose-induced metabolic disturbances are unclear but are beginning to be unraveled. In     contrast to metabolism of glucose, the breakdown of fructose leads to the generation of     metabolites that stimulate hepatic de novo lipogenesis (DNL) and increased levels of both     fasting and postprandial triglycerides. The key lipogenic transcription factor seems to be     activated by fructose independently of insulin. However, it is still controversial whether     fructose consumption increases DNL in man to the extent that it induces metabolic     disturbances. Animal studies have shown that also the adipose tissue is responsive to     fructose feeding fructose, and that high fructose-feeding induces insulin resistance and     inflammation in the adipose tissue. The role of intestinal insulin resistance in     fructose-induced dysmetabolism has not been studied in detail. The critical question is     whether the metabolic disturbances are induced by calorie excess or by fructose per se.   "
140493|NCT01445717|"     This study evaluates the use of a new method of growing and detecting Group B streptococcus     in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the     advantage of detecting GBS in less than 6 hours, with less cost, and the potential of     allowing antibiotic sensitivities to be performed.   "
140494|NCT01445704|"     The purpose of this study is to evaluate the success of daily supplementation of multiple     probiotic bacterial cultures over 12 weeks in increasing the percentage of excess weight loss     in the RNYGB (Gastric Bypass) weight loss population.   "
140495|NCT01445691|"     The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid     (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When     the investigators remove the tumor from your brain, it is important that they remove all of     the tumor and not remove parts of normal brain. Sometimes this can be difficult because the     tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red     under blue light. This may make it easier for your doctor to take out all of the tumor from     your brain. The purpose of this study is to:        -  Make sure that 5-ALA helps the doctor remove more of the tumor.        -  Make sure 5-ALA does not cause any side effects.      If you do not want to participate in this study, your doctor(s) will still do their best to     remove all of the tumor in your brain. Whether or not you join this study will not change     your treatment for your brain tumor.   "
140496|NCT01445678|"     This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of     CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus     meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections     (cIAI).   "
140497|NCT01445652|"     The purpose of this study was to evaluate the relative benefits of daily disposable contact     lenses versus spectacles in young adults.   "
140498|NCT01445639|"     Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent     sedation and analgesia without respiratory depression. Dexmedetomidine has been used in     critically ill medical, surgical, and pediatric patients. No study has been designed     specifically to evaluate dexmedetomidine uses in the neurocritical care population. The     primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic     analgesia and sedation in patients after intracranial surgery.   "
140499|NCT01445626|"     This study will use retrospective data to evaluate the efficacy, safety, and re-injection     interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).   "
140500|NCT01445613|"     The objective of the CANOPY trial is to assess the continued safety and effectiveness of the     RX Acculink Carotid Stent System under commercial use in subjects at standard risk for     adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of     carotid stenting experience.   "
140501|NCT01445600|"     This is an open label, multi-centre, non-interventional post-marketing surveillance.   "
140502|NCT01445587|"     This is a single arm, open-label, Phase Ib/II study to evaluate the safety, pharmacokinetics,     pharmacodynamics, and efficacy of the oral AKT inhibitor, GSK2110183, when administered to     subjects with proteasome inhibitor refractory multiple myeloma (MM). During Part 1 of the     study, GSK2110183 will be administered to subjects in sequential Pharmacokinetic (PK) Cohorts     on a continuous daily dosing schedule in 21-day cycles until one of the Treatment     Discontinuation Criteria is met. The PK Cohorts will characterize the PK of GSK2110183 in     plasma and urine as well as determine the Recommended Phase 2 Dose (RP2D) of GSK2110183. The     RP2D will be that dose that provides adequate PK exposure and biologic activity without     exceeding the maximum tolerated dose (MTD) in MM subjects as defined in the current study. In     Part 2 of the study, the RP2D will be further evaluated using a flexible 2-stage design with     a stopping rule to allow for early termination based on lack of efficacy at the end of Stage     1. The first stage will accrue 20 subjects who will receive GSK2110183 at the RP2D. If a     clinical response is observed in at least 1 subject in Stage 1, the study will proceed to     Stage 2 and 20 additional subjects will be enrolled. GSK2110183 will be administered in Part     2 (Stage 1 and Stage 2) on a continuous daily dosing schedule in 21 day cycles until     International Myeloma Working Group criteria for progression are met, at which point the     subject will proceed to GSK 2110183 + bortezomib salvage therapy provided they meet the     additional eligibility criteria for this phase of the study. GSK2110183 and bortezomib will     be continued until one of the Treatment Discontinuation Criteria is met.      Exploratory PK/PD analyses may be performed to examine the potential relationships between     GSK2110183 pharmacokinetics and pharmacodynamic biomarkers.   "
140549|NCT01444846|"     Exposure to loud sounds can cause hearing loss. The purpose of this research study is to     evaluate potential prevention of temporary changes in hearing that may occur after listening     to music through an iPod or personal music player. We will measure temporary changes in     hearing in subjects who listen to music and take either the study drug, SPI-1005, or a     placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be     taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione     Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.   "
140721|NCT01442584|"     Ovarian transplantation has been shown to restore fertility.   "
140503|NCT01445561|"     Background:      - Interleukin-2 is a drug that can help stimulate the body s response to inflammation. High     dose interleukin-2 has been used to treat different types of cancer and immune system     disorders. However, it can cause frequent and often serious side effects at the doses     currently used for treatment. Very low dose interleukin-2 (700 folds less than regular dose)     was previously tested in cancer patients and stem cell transplant recipients. The study     observed important immune changes and minimal side effects in those patients. Researchers     want to test the healthy immune system's responses to very low doses of interleukin-2 to     better understand how the drug works.      Objectives:      - To study the effects of very low doses of interleukin-2 on healthy volunteers.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood and urine samples.        -  Participants will receive one of two possible very low doses of interleukin-2 every day          for 5 days.        -  Blood samples will be taken twice before the first dose, 1 day after the first dose, and          before the next three doses. Followup blood samples will be taken on Days 7, 14, and 28          after the first dose.   "
140504|NCT01445548|"     This study will determine whether a drug called sirolimus is safe to give to people with     geographic atrophy (GA) and if it can help preserve vision in patients. GA is an advanced     form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part     of the retina at the back of the eye needed for sharp, clear vision. There are two types of     AMD, wet and dry. In dry AMD, cells in the macula die.      GA may be partially caused by inflammation. Sirolimus helps prevent inflammation and     therefore may help people with GA. Researchers want to see whether sirolimus can help prevent     vision loss in people with GA.      People at least 56 years of age who have GA related to AMD in both eyes may be eligible for     this study.      This study requires at least 8 visits to the National Eye Institute over 1 year. Study visits     will be every 2 months for 1 year.      Participants will undergo the following procedures:        -  Participants will be screened with a medical history and physical exam. They will also          have blood and urine tests, and eye exams. One eye will be selected as the study eye to          receive the sirolimus injections.        -  Participants will have a sirolimus injection into the study eye at the first visit and          every 2 months thereafter unless contraindicated. There will be a follow-up eye exam 1          month after the first injection.   "
140505|NCT01445535|"     Studies conducted at the National Cancer Institute suggest that certain chemotherapy drugs     may be more effective if given by continuous infusion into the vein rather than by the     standard method of rapid intravenous injection. One such combination of six chemotherapy     drugs, known as EPOCH-R, has had a high degree of effectiveness in people with certain kinds     of cancer. Recent evidence also indicates that the effects of chemotherapy may be improved by     combining the treatment with monoclonal antibodies, which are purified proteins that are     specially made to attach to foreign substances such as cancer cells. This protocol is     specifically for adults with the types of cancer known as T-cell and NK-cell lymphomas, who     have never received chemotherapy previously. The additional monoclonal antibody in the study,     called siplizumab, has been manufactured to attach to the CD2 protein contained in these     types of tumors.      Study volunteers will need to undergo an initial period of evaluation that may take up to 3     weeks and may be done on an outpatient basis. Evaluation may include some or all of the     following tests: blood and urine tests, tests of lung and heart function, lumbar punctures to     take samples of cerebrospinal fluid, magnetic resonance imaging (MRI) or computerized     tomography (CT) scans, full-body positron emission tomography (PET) scans, bone marrow     biopsies, and biopsies of suspected tumor areas.      During the study, patients will receive EPOCH-R chemotherapy, which includes the following     drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. The     additional drug, siplizumab, will be given by IV infusion on the first day of treatment over     several hours. When the siplizumab IV infusion is complete, the drugs doxorubicin, etoposide,     and vincristine will each be given by continuous IV infusion over the next 4 days (that is,     continuously for a total of 96 hours). When this infusion is completed, the drugs rituximab     and cyclophosphamide will be given by IV infusion over several hours on Day 5. Prednisone     will be given by mouth twice each day for 5 days. Patients may be given other drugs to treat     the side effects of chemotherapy and to prevent possible infections.      The siplizumab-EPOCH-R therapy will be repeated every 21 days, which is known as a cycle of     therapy, for a total of 6 cycles. Following the fourth and sixth treatment cycles     (approximately weeks 12 and 18) of siplizumab-EPOCH-R, study researchers will perform blood     tests and CT/MRI scans on all patients to assess their response to the treatment.   "
140506|NCT01445522|"     Background:        -  Cyclophosphamide (CP) is a drug approved by the Food and Drug Administration for the          treatment of certain cancers. It works by causing DNA damage, resulting in cell death,          including cancer cells.        -  ABT-888 is an experimental drug that has been given to a small number of patients. It          works by preventing DNA repair in tumor cells.      Objectives:        -  To test the safety of the combination of ABT-888 and CP, and to determine the dose of          each drug that can be given together to patients with cancer.        -  To see how the body handles ABT-888 when given together with CP        -  To evaluate the anti-tumor response of the drug combination.      Eligibility:        -  Adults with solid tumors or lymphoid cancers (lymphoma and chronic lymphocytic leukemia)          whose disease does not respond to standard treatments.      Design:        -  Patients take ABT-888 by mouth once a day for 7, 14 or 21 days, depending on the dose          level assigned to the individual patient.        -  Patients take CP by mouth once a day every day in 21-day cycles. (Some patients take CP          for 14 days only.)        -  Patients undergo tests and procedures periodically during the study, including:        -  Clinic visit and physical examination at the beginning of each cycle        -  Blood and urine tests, electrocardiogram, measurement of vital signs        -  CT scans, MRI scans or ultrasound tests to check the response of the tumor to treatment        -  Tumor biopsies (optional)        -  Bone marrow aspiration and biopsy   "
140507|NCT01445509|"     Background:        -  Bevacizumab inhibits blood vessel growth in cancer cells by blocking a growth factor          called VEGF. Dasatinib inhibits the action of proteins called tyrosine kinases, which          promote and stimulate blood vessel formation and cancer growth and spread.        -  Using the two drugs in combination may provide a more effective cancer treatment than          either drug used alone.        -  Both drugs have been approved by the Food and Drug Administration for different cancer          types, but their use in combination sis experimental.      Objectives:      - To determine the highest doses of the combination of dasatinib and bevacizumab that can be     safely given to patients with different cancers and to find out what effects, good and bad,     these drugs may have on the patient and the disease.      Eligibility:      - Adult patients with an advanced solid tumor cancer that cannot be treated successfully with     standard therapies.      Design:        -  Patients in Group 1 receive dasatinib and bevacizumab together throughout the study. The          dose is increased in successive groups of three to six patients until the optimum safe          dose is determined. Patients take dasatinib by mouth once a day and receive bevacizumab          as an infusion through a vein once every 2 weeks in 28-day treatment cycles.        -  Patients in Group 2 are randomly assigned to receive either dasatinib or bevacizumab for          cycle one, and then both drugs for all subsequent cycles. The drug doses are based on          the optimum doses found in Group 1 patients.        -  Patients have a physical examination and blood and urine tests every 2 weeks for cycles          1 and 2, and then every 4 weeks for the duration of treatment.        -  Patients have CT or MRI scans or another imaging test such as ultrasound every 8 weeks          to monitor the cancer s response to treatment.        -  Tumor biopsies are obtained from patients in Group 2 before treatment, 2 weeks into the          first treatment cycle, and 2 weeks into the second cycle.        -  Dynamic, contrast-enhanced MRI (DCE-MRI) tests are done on patients in Group 2 before          treatment, 2 weeks into the first cycle and 4 weeks into the second cycle. This MRI test          uses a special non-radioactive dye that shows blood flow in a certain part of the body.        -  For patients who have been on the study over 2 years, the cycle may be lengthened to 6          or 8 weeks at the discretion of the investigator.   "
140509|NCT01445444|"     The purpose of the current study is:        1. To evaluate the effectiveness of a habit reversal training (HRT) approach for children          ages 7 to 17 years of age inclusive with a diagnosis of trichotillomania.        2. To explore factors that may relate to symptom severity, treatment outcome, and          psychosocial impairment (e.g., specific symptom presence, co-morbidity, emotional          regulation).   "
140510|NCT01445431|"     Among adult patients with chronic kidney disease undergoing hemodialysis, what is the     efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic     moisturizer for uremic xerosis?   "
140511|NCT01445418|"     Background:        -  Carboplatin is approved by the Food and Drug Administration to treat cancer.        -  AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a          protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that          process.      Objectives:        -  To determine the optimum doses of AZD2281 and carboplatin that can safely be used in          patients with breast and ovarian cancer.        -  To evaluate the response of the tumor to the drug combination and determine the side          effects of the treatment.      Eligibility:      -Patients 18 years of age or older with breast or ovarian cancer who have a family history of     cancer or who have a BRCA1 or BRCA2 mutation.      Design:        -  In this dose escalation study, the first small group of patients receives the smallest          study doses of AZD2281 and carboplatin. Subsequent groups receive incrementally higher          doses of first AZD2281 and then carboplatin as long as the preceding group has not          experienced unacceptable side effects. When the highest safe dose is determined,          additional patients receive that dose.        -  Patients receive treatment in 21-day cycles as follows: AZD2281 by mouth twice a day          every day; carboplatin thorough a vein on day 8 of each cycle. Treatment may continue          until it is no longer beneficial.        -  Evaluations during treatment include the following:        -  Physical examination 1 week after starting treatment and then every 3 weeks.        -  Blood tests weekly for the first 4 weeks of treatment and then every 3 weeks.        -  CT scans or other imaging tests such as ultrasound or MRI every 6 weeks to evaluate the          tumor.   "
140512|NCT01445405|"     Background:      Bortezomib acts on molecules in head and neck cancer cells that are important for the cells     growth and survival. The drug may help make the cancer more sensitive to radiation and other     chemotherapy drugs.      Cetuximab is a monoclonal antibody that has increased the effectiveness of radiation     treatment in patients with head and neck cancer in clinical trials.      Cisplatin has shrunk head and neck cancers and improved treatment response and survival when     combined with radiation treatment.      Objectives:      To determine the highest safe dose of bortezomib when combined with cetuximab without or with     cisplatin and with radiation in patients with advanced head and neck cancer.      To examine the benefits and side effects of these drug combinations with radiation in     patients with advanced head and neck cancer.      Eligibility:      Patients 18 years of age and older with advanced Stage IV head and neck cancer who have not     previously had neck radiation.      Design:      Patients will be assigned sequentially to one of two treatment groups: Group A receives     bortezomib and cetuximab beginning the week before, and for the duration of, radiation     therapy; Group B receives bortezomib, cetuximab and cisplatin beginning the week before, and     for the duration of, radiation therapy.        -  Cetuximab is given as a 2-hour infusion through a vein (intravenously, IV) for the first          dose and then over 1 hour for subsequent weekly doses.        -  Bortezomib is given as an injection into a vein over about 5 seconds, twice a week for 2          weeks, followed by a 1-week rest for a total of three 3-week treatment cycles during          radiation.        -  Cisplatin is given in once a week as a 1-hour IV infusion        -  Radiation therapy is given 5 days a week for 7 to 8 weeks.      Post-treatment follow-up:        -  Until 2 weeks after treatment ends, patients are followed once a week including a          physical examination, review of treatment side effects, and blood tests.        -  For 2 months after treatment ends, patients may need to return to the hospital for          medical evaluation and supportive care, depending on their condition.        -  8-weeks after treatment ends, patients return for evaluation with a history and physical          examination; blood tests; ear, nose and throat evaluation and endoscopy; CT or MRI scan,          or both, of the neck and chest; and, if indicated, a PET scan....   "
140513|NCT01445392|"     Background:      Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin.     However, the benefits of this treatment are limited, and in most treated patients the disease     continues to worsen.      SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a     certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a     bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the     cancer cells, allowing the toxin to enter and kill the cells.      Objectives:      To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in     patients with mesothelioma.      To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not     cause unacceptable side effects).      To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients     tumors.      To learn how the body breaks down SS1(dsFV)PE38.      Eligibility:      Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot     be cured with surgery, and have not had prior treatment with chemotherapy.      Design:      Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:        -  Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin.        -  Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with          SS1(dsFV)PE38.        -  Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients          are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no          significant side effects, the next group a higher dose. This continues in succeeding          groups until the maximum tolerated study dose (highest dose that patients can be given          safely) is determined.      Continuing standard treatment with additional cycles of pemetrexed and cisplatin.      Evaluations during the treatment period:        -  Physical examination, including vital signs and body weight checks, and pregnancy test          for women who can become pregnant.        -  Questions about medications and side effects.        -  Blood and urine tests.        -  Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests,          pulse oximetry, performance of daily activities and quality-of-life questionnaires.      Post-treatment evaluations:        -  Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease          assessment.        -  End-of-study visit for blood tests, vital signs and weight measurements, disease          assessment, electrocardiogram, pregnancy test for women who can become pregnant   "
140722|NCT01442571|"     The proposed research is to examine the effect of injecting a large volume of HA (10cc) at     the time of post arthroscopy suture removal (9-11 day post surgery), in patients with     cartilage damage of ICRS grade 2 and above in one of the knee compartments.   "
140514|NCT01445379|"     This study will examine the safety and efficacy of ipilimumab-an experimental cancer     treatment drug used to boost immune response-in children, adolescents, and young adults.     Ipilimumab may allow immune cells to react to and destroy abnormal cells in the body, and has     been tested in adults for a variety of cancers and has shown responses in some research     studies. Because ipilimumab has not been tested in children, adolescents, or young adults, it     is considered an experimental drug. The purposes of this research study are to determine the     highest safe dose of ipilimumab for children, adolescents, and young adults with solid tumor     cancers; examine its effectiveness and possible side effects; and better understand how the     body and the immune system process it over time.      Candidates must be between 2 and 21 years of age and must have solid malignant tumors that     have been resistant to standard therapy. Volunteers will be screened with a medical history,     a clinical examination, and computerized scans such as magnetic resonance imaging (MRI).     Participants must have completed their last dose of chemotherapy, radiation, chemotherapy, or     antibody or investigational therapy at least four weeks prior to enrollment.      During the study, participants will receive an intravenous dose of ipilimumab once every     three weeks. The infusion of ipilimumab will last 90 minutes, and the participant s vital     signs will be monitored while the medicine is infusing and several times in the first 24     hours after the first dose (requiring a hospital stay during that time). If the participant     is able to tolerate the first dose of ipilimumab, further doses (called cycles ) may be     received on an outpatient basis. Blood and urine tests will be given on a regular basis     during these cycles. After four cycles, participants whose tumors do not grow and who do not     have unacceptable side effects will continue to receive ipilimumab every three months to     maintain the current condition, until researchers conclude the study.   "
140521|NCT01445275|"     This research trial collects information about types of treatment and the cost of these     procedures in women with elevated genetic risk for ovarian cancer who participated on the     Gynecology Oncology Group (GOG)-0199 trial. Gathering information about women at elevated     genetic risk for ovarian cancer may help doctors learn more about risk reduction procedures     and the cost of these procedures.   "
140515|NCT01445366|"     This is a prospective cross-over study including 10 stable hemodialysis patients with chronic     kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions     at midweek.      During one session, the patient will be dialyzed during 4 hours with high volume post     dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a     blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min.      During the other midweek session, the patient will be dialyzed during 8 hours with high flux     hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of     200mL/min and a dialysate flow of 500mL/min.      The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post dialysis     from the arterial blood line, and after 30min after dialysis start, a blood sample will be     drawn from the inlet and outlet line.      At the dialysate outlet line, partial dialysate collection is performed at the outlet line.      Blood and dialysate samples will be analyzed for a broad range of retention solutes like     small and water soluble solutes, middle molecules, and protein bound solutes.      These data will be further used to calculate solute removal and evaluate any differences     between the solute removal during high volume post dilution HDF and high flux HD.   "
140516|NCT01445340|"     Background:        -  Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The cancer          cells are found in red, scaly patches that may sometimes itch.        -  Early-stage CTCL is usually treated with topical therapies, which may lose effectiveness          over time and have adverse effects, such as risk of secondary skin cancers and          difficulty of use.        -  Romidepsin is an experimental drug that, given through a vein, has improved CTCL in some          patients with later stages of the disease.        -  A topical ointment form of romidepsin may be helpful in treating early-stage CTCL.      Objectives:        -  To determine the highest tolerated dose of topical romidepsin that can be given to          patients with early-stage CTCL.        -  To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL.        -  To determine how the body handles topical romidepsin.      Eligibility:      -Patients 18 of age and older with early-stage CTCL.      Design:        -  Study Part 1: Successive groups of 3 patients are treated with increasingly higher          concentrations of topical romidepsin until the highest tolerated dose is found.        -  Study Part II: The highest tolerated dose, as determined in Part I, is applied to larger          areas of skin in another group of patients.        -  All study participants apply the study medicine to their skin three times a day for 4          weeks.        -  During treatment, participants are monitored at weeks 2 and 4 with a history and          physical examination, blood tests, electrocardiogram, skin biopsies and photographs of          the skin.        -  After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood          tests and to see how the study medication is affecting the body.   "
140517|NCT01445327|"     Background:        -  Gastrointestinal cancers are among the most commonly diagnosed cancers in the United          States.        -  There are currently no tests to predict how patients with gastrointestinal cancers will          respond to radiation therapy or which patients may develop side effects from treatment.        -  Studies on tumor cells in the stool, urine, or blood from patients may provide valuable          information that can be used to develop tests to determine which patients may need more          or less aggressive therapy.        -  Studies of other substances in the stool, urine, or blood from patients may provide          valuable information that can be used to develop tests to determine which patients are          likely to develop side effects from radiation treatments.      Objectives:        -  To collect blood, urine and stool specimens from patients with gastrointestinal cancers          who will undergo radiation therapy.        -  To study hormone and protein changes in these blood, urine and stool specimens before,          during and after radiation treatment in order to develop a way to predict how          gastrointestinal cancers will respond to radiation therapy and if patients with these          cancers will develop side effects from radiation treatment.      Eligibility:      -Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus,     stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an     NCI protocol      Design:      Participants undergo the following procedures:        -  Tumor biopsy: Before any treatment or at the time of surgery if it is the first          treatment        -  Urine collection: Before, during, and after treatment and at follow-up visits.        -  Stool collection: Before, during, and after treatment and at follow-up visits.        -  Blood collection: Before, during, and after treatment and at follow-up visits.        -  Intestinal permeability assessment: Before any treatment, before radiation (if radiation          is not the first treatment), 1 month after radiation is completed, and 3 months after          radiation is completed. This test determines how the patient s intestines are working to          absorb sugar and may provide information about side effects from radiation treatments.          Patients fast after midnight, then drink a small glass of sugars, and then do a 6-hour          urine collection.   "
140518|NCT01445314|"     Background:        -  People with chronic illness often are at risk for developing neurobehavioral problems          due to effects of the disease or associated treatments. These problems may include          cognitive impairments involving problem-solving, remembering things, paying attention,          and understanding and using language, or emotional functioning or quality of life.        -  The National Cancer Institute Medical Illness Counseling Center Neuropsychology Group          has collected data from neurobehavioral evaluations of infants, children, adolescents          and adults with chronic illnesses enrolled in NIH protocols since 1987 and continues to          collect data from patients enrolled in current protocols.        -  The data from these evaluations, along with demographic and medical information are          stored in an NIH computer database.        -  Investigating the neurobehavioral functioning of patients with chronic illness is          important for identifying and monitoring the effects of the disease and treatments over          time, determining possible at-risk subgroups, evaluating response to therapy, and          recommending educational and rehabilitative interventions.      Objectives:      -To learn about how certain illnesses or treatments may affect a person s cognitive     abilities, emotional functioning and quality of life.      Eligibility:        -  Patients currently enrolled in NIH studies who are having neuropsychological testing or          completing quality-of-life questionnaires as part of that study.        -  Data obtained from infants, children, adolescents, and adults administered          neurobehavioral assessments as part of a past or future NIH protocol.      Design:        -  This study does not involve any extra tests or questionnaires; it uses information          collected from evaluations that subjects have already completed or will complete as part          of other NIH studies.        -  Information about participating patients that may help elucidate how cognitive          abilities, emotional functioning, and quality of life are affected in people with          chronic illness may be collected and stored.   "
140519|NCT01445301|"     This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled     (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to     demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO] 3% gel) when applied     once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when     applied topically either once or twice daily for 12 weeks.   "
140520|NCT01445288|"     This study will analyze the effects of radiation given to children who have tumors of the     central nervous system (CNS). Researchers want to learn more about changes in the quality of     life that patients may experience as a result of radiation.      Patients ages 21 and younger who have a primary CNS tumor and who have not received radiation     previously may be eligible for this study. They will have a medical history and physical     examination. Collection of blood (about 2-1/2 tablespoons) and urine will be done, as well as     a pregnancy test. Patients will complete neuropsychological tests, which provide information     about their changes in functioning over time. An expert in psychology will give a number of     tests, and the patient's parents or guardian will be asked to complete a questionnaire about     the patient's behavior. Also, patients will be given a quality of life questionnaire to     complete and vision and hearing tests. The radiation itself is prescribed by patients'     doctors and is not part of this study.      Magnetic resonance imaging (MRI) will give researchers information about the tumor and brain,     through several scanning sequences . MRI uses a strong magnetic field and radio waves to     obtain images of body organs and tissues. Patients will lie on a table that slides into the     enclosed tunnel of the scanner. They will need to lie still, and medication may be given to     help them to do that. They may be in the scanner for up to 2 hours. As the scanner takes     pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to     reduce the noise. A contrast agent will be administered, to allow images be seen more     clearly. Blood and urine tests will be conducted after the first dose of radiation. MRI scans     will be done 2 weeks after patients finish radiation therapy and again at 6 to 8 weeks, 6     months, 12 months, and yearly. Also at those follow-up periods, patients will undergo similar     procedures as previously, including blood and urine tests and neuropsychological testing.     Patients can remain in this study for 5 years.   "
140523|NCT01445249|"     Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and     is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this     work. The purpose of this study is to compare two techniques: one using anatomical landmarks     alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation     to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques     will be compared for reliability of postoperative analgesia.   "
140524|NCT01445236|"     Immunosuppressive drugs can be successfully withdrawn in a fraction of liver transplant     patients. Specific peripheral blood gene expression markers can be employed to select     patients with a high likelihood of being tolerant. In the current study the investigators     propose to conduct a pilot non-randomized prospective study in which gradual weaning of     immunosuppressive drugs will be offered to liver recipients exhibiting a favorable peripheral     blood gene expression profile.   "
140525|NCT01445223|"     The present study aims to compare efficacy, side-effects, and treatment adherence of three     different treatment regimens given to antiretroviral naïve HIV-1 infected patients. Treatment     will be initiated in accordance with the Swedish National Guidelines. In the twice daily     (BID) arm (1), which could be considered as a standard regimen at present,     lopinavir/ritonavir, is co-administrated with 2 nucleoside reverse transcriptase inhibitors     (NRTIs) administrated BID. The first once daily (QD) arm (2) combines the protease inhibitor     (PI) atazanavir/ritonavir with 2 NRTIs administrated QD, and in the second QD arm (3), the     non nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz is combined with 2 NRTIs     administrated QD. All drugs used in the study are licensed in the participating countries and     patients will be followed as in clinical practice. Patients could optionally, after informed     consent, be followed with additional measurements of HIV-1 RNA after 1, 2, and 3 weeks of     treatment to asses the kinetics of viral decline after initiation of treatment.   "
140526|NCT01445210|"     The most useful method to manage pain after major ankle surgery is infusion of local     analgesics with a catheter close to the sciatic nerve.      Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified     in the sciatic nerve) and the saphenous nerve.      Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve     catheter provide a better treatment of pain in comparison with a single injection nerve     block. In addition cost-effectiveness of the two methods are compared.      The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary     analysis of the data from the first 40 patients. However, it is not an interim analysis.     Fifty patients will be included independent of the result of the preliminary analysis. The     random allocation of the last 10 patients will also be double-blinded.   "
140527|NCT01445197|"     This is a clinical study to investigate how well Biostate works in treatment of male patients     below the age of 12 years who have a clotting factor deficiency that is aggravated by the     development of antibodies. The antibodies are directed against the clotting factor that is     given for replacement therapy and usually make therapy unsuccessful. The treatment used in     this study is called immune tolerance therapy.   "
140528|NCT01445171|"     The purpose of this clinical investigation is to confirm that the safety and performance of     the EDWARDS INTUITY Valve System.   "
140529|NCT01445158|"     Background:        -  Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major          organ transplant in the United States.        -  Pediatric 1st degree stem cell donors can experience a variety of psychological          difficulties before and after donation with those who feel they are not adequately          prepared for possible complications following stem cell donation and transplant          describing negative emotions.        -  The importance of preparation for children undergoing medical procedures has long been          recognized in the field of pediatric psychology      Objectives:        -  To assess how prepared pediatric donors are for stem cell donation by assessing their          knowledge about stem cell transplants, and to assess their anxiety at different stages          of the donation process.        -  To assess the effectiveness of a workbook and a board game as tools for conveying          information on donation and transplantation to donors.        -  To identify donors who may require additional preparation before stem cell collection.        -  To explore the relationship between donor knowledge and anxiety symptoms.      Eligibility:      -Stem cell donors ages 10 to 26 years of age      Design:        -  Participant s baseline knowledge and anxiety are evaluated.        -  Participant s knowledge is reassessed and anxiety evaluated following an information          session with the research nurse and doctor about the procedures for stem cell donation          and discussion of the consent form for the transplant protocol.        -  Participants are separated into two groups. Donors 10 to 15 years of age play a board          game; those 16 to 26 years of age are given a workbook on stem cell transplant.        -  Participants knowledge and anxiety are reassessed within 24 hours after working with the          educational materials and again 1 month later.   "
140566|NCT01444625|"     As flavanols have antioxidants, anti-inflammatory and anti-DNA damaging effects and may     increase microcirculation in skin, the purpose of the study is to investigate the chronic     effect of flavanol-rich chocolate as an effective strategy to protect against the harmful     effect of ultraviolet (UV) radiation.   "
140530|NCT01445145|"     Background:        -  Few resources exist for helping adolescents and young adults with cancer or HIV disease          understand their changing physical, emotional and social needs when treatment is no          longer effective.        -  An advance directive document called Five Wishes has had particular success with the          adult population because of the consideration of personal, emotional and spiritual needs          in addition to medical and legal concerns.      Objectives:      -To learn which questions in Five Wishes are useful for adolescents and young adults and to     then create a new document that reflects the issues they feel are most appropriate for people     with cancer or HIV disease.      Eligibility:      -Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease     acquired perinatally or early in life and enrolled in an active NIH treatment protocol.      Design:        -  Stage 1: Participants go through each question in Five Wishes and respond to whether          they feel the questions are useful.        -  Stage 2: Participants are asked to compare each question from Five Wishes to a newly          developed document based on the feedback received during first stage of the study.        -  Participants are enrolled for either Stage 1 or Stage 2 depending on the date they enter          the study.   "
140538|NCT01445028|"     Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an     important cause of retinal re-detachment. The purpose of this study is to evaluate the effect     of oral isotretinoin, which inhibits the growth of cells responsible for proliferative     vitreoretinopathy (PVR), on recurrent retinal detachment.   "
140539|NCT01445015|"     The study will utilize a stress management program delivered over 10 sessions that is     hypothesized to result in decreased stress levels and improved coping strategies in an inner     city adolescent asthma population. Participants will include adolescents ages 10-15 years     with physician diagnosed asthma. The outcome measures will be obtained via psychosocial     questionnaires and spirometry.   "
140531|NCT01445132|"     Background:        -  After allogeneic (donor) stem cell transplantation, a new immune system grows in the          patient from the transplanted donor stem cells and lymphocytes (type of immune cell).          Donor lymphocytes, unlike the patient s own lymphocytes, often can recognize the patient          s tumor cells as being foreign and destroy them.        -  It is thought that tumor shrinkage after stem cell transplantation is the result of          donor T lymphocytes, or T cells. Some studies show that patients with tumors that have T          cells are better able to keep tumor growth in check.        -  Patients who have had donor stem cell transplantation may have donor T cells in their          tumors that can recognize and fight their cancer. Compared with donor T cells taken          directly from the donor and infused into the patient, donor T cells found in patients          tumors may be specific for the cancer cells and thus better able to attack tumor. Also,          because the T cells found their way to the tumor, they may be less likely to recognize          and attack non-tumor tissues than the T cells given in donor lymphocyte infusions.        -  The T cells may be especially effective at controlling tumor if they are given an          additional stimulus to become active. Costimulation is the name of the body s natural          process for providing an extra stimulus, and can be performed on cells in the          laboratory. Costimulation can produce large numbers of activated cells that may be able          to attack cancer cells and shrink tumors.      Objectives:      -To evaluate the ability of lymphocytes found in tumors from patients who have received donor     stem cell transplants to control their tumor growth.      Eligibility:      -Patients between 18 and 75 years of age with a B-cell cancer that has continued to grow or     recurred after remission following allogeneic stem cell transplantation. This includes     patients who have received transplants from unrelated donors and cord blood.      Design:        -  Immune cells are collected from patients blood and blood from their stem cell donor.        -  Patients undergo surgery to remove their tumor and a small piece of skin. In the          laboratory, donor T cells are isolated from the tumor and costimulated to expand the          number of cells and activate them.        -  The expanded, activated T cells as infused into the patient.        -  Patients have a needle biopsy and possibly surgery to remove a sample of remaining tumor          for research studies.        -  Patients are followed at the NIH clinic 48 hours after the cell infusion, and again at          1, 2, 4, 8 and 12 weeks after the infusion. Tumor size is monitored every month with CT          scans, and possibly also with a PET or bone marrow aspiration and biopsy, for the first          3 months after the cells are infused. Thereafter, visits are less frequent (every 3          months, then every 6 months, and then yearly) during a minimum 5-year follow-up.   "
140532|NCT01445119|"     This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug     that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients     who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of     cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and     accumulation, requiring a blood supply. Research shows that brain tumor cells can produce     substances that stimulate new blood vessel formation. This study will look into whether the     combination of drugs can stop that process.      Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast     feeding, and who do not have serious diseases may be eligible for this study. About 96     patients will participate for 1 year. They will have a physical examination, give blood and     urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed     tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may     also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to     distinguish a live tumor from a dying one. Researchers are studying patients taking a certain     type of antiseizure medicine and patients who are not taking it because some antiseizure     medicines may change the way the body handles a drug such as Enzastaurin. There will be two     groups of participants, with 16 to 48 each. Group A is not taking enzyme-inducing antiseizure     drugs, and Group B is taking such drugs. In Groups A and B are four dose levels, with 4 to12     patients at each level. Patients' doctors will tell them which group they belong to and how     much Enzastaurin and Carboplatin they will take. Treatment consists of Enzastaurin every day     for 5 weeks in Cycle 1 only and for 4 weeks beginning with Cycle 2 (each 4-week period as a     cycle). Patients take Enzastaurin within 30 minutes after a meal. History, physical, and     neurological examinations are repeated at the end of Cycle 1 and then every 4 weeks. Patients     will have a repeat head MRI or CT scan before each cycle. If they tolerate the drugs without     serious side effects and the tumor is not growing, they may continue with another cycle of     Enzastaurin, taking the tablets every day, and Carboplatin being infused on Day 8 of Cycle 1     and on Day 1 of each additional cycle. Routine lab tests are done regularly. Patients will     continue the 4-week cycles of treatment for as long as they have no serious side effects and     there are no signs of tumor growth. Side effects of Enzastaurin may be fatigue, constipation,     cough, and nausea. In men, there may be a decrease in sperm count. Carboplatin can lead to     low counts in blood cells and platelets, and there may also be an allergic reaction. Vomiting     is a likely side effect. At injection sites, there may be redness, swelling, and pain.      This study may or may not have a direct benefit for participants. However, information gained     may help the sponsor of the study, Eli Lilly and Company, and may help patients in the future     who have gliomas.   "
140533|NCT01445106|"     Background:        -  The PI3K/Akt/mTOR pathway is an important target in cancer because it promotes          chemotherapeutic resistance and confers a poor prognosis for many types of cancers.        -  Several inhibitors of the pathway are being developed as cancer therapeutics. However,          the process of de novo drug development takes years, and is often curtailed due to          diminished activity and/or unforeseen toxicities in clinical trials.        -  One approach to expedite the development of new cancer therapies is to test drugs that          are already approved for other indications.        -  Our group has shown that nelfinavir, an orally available FDA-approved HIV-1 protease          inhibitor used to treat HIV/AIDS, can inhibit endogenous Akt and growth factor receptor          induced Akt activity in cancer cells.        -  Importantly, nelfinavir demonstrates dose-dependent cytotoxicity in every cell line in          the NCI 60 cell line panel at plasma concentrations attainable in human plasma, is          profoundly effective in cancer cell lines that have been selected to become resistant to          standard therapies, and inhibits tumor growth in-vivo.      Objectives:        -  Because an MTD with nelfinavir has not been observed in prior phase I studies with HIV          patients, the objectives of the Phase I design will be:        -  To establish the MTD and dose limiting toxicity for this drug in patients with solid          Tumors.        -  To correlate nelfinavir pharmacokinetics with baseline activity of CYP3A4 as assessed by          measuring midazolam clearance.        -  To preliminarily explore the biological and clinical effects through a series of          correlative studies involving analysis of blood and tissue across patients throughout          the study.      Eligibility:      -Adults with solid tumors who are refractory to, or have relapsed after receiving, standard     front-line chemotherapies are eligible.      Design:        -  Patients will receive nelfinavir beginning at the FDA-approved dose for HIV patients          (1250 mg po bid).        -  Dose escalations will occur for 6 dose levels i.e. cohorts, or until the MTD is reached.        -  Up to 45 patients are expected to be enrolled.        -  Staging CT scans will be performed every two cycles.   "
140534|NCT01445080|"     Background:        -  Sorafenib is an experimental anti-cancer drug that works by blocking proteins thought to          be important for tumor growth. It has blocked the growth of tumors in test tubes and in          some animal models.        -  Sorafenib is approved for the treatment of advanced kidney cancer.        -  This is the first time sorafenib is being tested in children with cancer.      Objectives:        -  To determine the highest dose of sorafenib that can be safely given to children and          young adults with cancer.        -  To determine the side effects and benefits, if any, of sorafenib in children and young          adults with cancer.        -  To study how the body handles sorafenib and the drug's effects on cells and proteins in          the blood.      Eligibility:      -Patients between 2 and 21 years of age with solid tumors or leukemias that do not respond to     standard treatment.      Patients between 2 and 21 years of age with AML and FLT3-ITD mutation for Part C of the     study.      Design:        -  Patients take sorafenib tablets every day about every 12 hours in 28-day treatment          cycles for a maximum of 24 cycles.        -  The dose is increased in succeeding groups of 3 to 6 children until serious side effects          occur. Subsequent patients then receive the drug at lower doses.        -  Patients have a physical exam, blood and urine tests, and CT or MRI scans periodically          to monitor safety and treatment effects. Leukemia patients also have bone marrow          aspirates. Patients with a solid tumor may have an MRI. Children whose bones are still          growing have X-rays of the lower legs periodically to monitor bone structure.        -  Patients have additional blood studies to determine the amount of sorafenib in the          blood, the effect of the drug on proteins and cells in the blood, and genetic          differences that affect how individuals respond to the drug.   "
140535|NCT01445067|"     The purpose of this study is to evaluate the pharmacokinetics (PK) of BMS-927711 during     migraine and non-migraine condition.   "
140536|NCT01445054|"     Background:        -  Some breast cancer cells have specific proteins (receptors) on their surface that make          the tumor grow faster than normal cells. One of these receptors is called HER2/neu.        -  An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the          cancer cell.        -  Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has          been attached to a tiny amount of Herceptin.      Objectives:      -To see if Indium-Herceptin provides information about the characteristics of the breast     cancer in women whose tumors express HER2/neu and those whose tumors do not.      Eligibility:      -Women 18 years or older with primary or metastatic breast cancer who have not received     treatment with herceptin for at least 6 months before enrollment into the study.      Design:        -  Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu          status.        -  Patients have a physical examination and review of medical records.        -  Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma          camera that detects the radioactivity in the Indium-Herceptin.        -  Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine          the best time to image after injection of Indium-Herceptin.        -  Blood samples are obtained every day of scanning to monitor the effects, if any, of the          Indium-Herceptin and to see how fast the agent leaves the body.   "
140723|NCT01442558|"     The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial     plexus blocks for surgical anesthesia   "
140537|NCT01445041|"     Further study details as provided by Duke University:      Purpose: To evaluate the feasibility and safety of collecting and infusing autologous     umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS).      Study Rationale and Hypotheses: The major goal of this study is to determine whether infusion     of autologous UCB cells in neonates with hypoplastic left heart syndrome is feasible and     safe. The rationale for the study and for the potential benefit of UCB is based upon the     following hypotheses:        1. Infants with HLHS have significant neural injury evidenced from both prenatal and early          antenatal brain MRI findings and infusion of UCB cells may lessen neural injury.          Although the exact mechanism is unknown, UCB cell infusion may ameliorate neural injury          via paracrine and anti-inflammatory effects that enhance post injury repair and may          promote endogenous functional compensation of other cortical areas resulting in          significant clinical improvements.        2. UCB cells may also enhance cardiac function, minimize scar formation, and reverse          detrimental remodeling after cardiac injury.   "
140540|NCT01445002|"     The study will evaluate the dose response of immunotherapy against grass pollen allergy using     the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:        -  skin prick testing        -  grass pollen inhalation challenge        -  antibody responses. In addition, the safety of subcutaneous application of BM32 will be          evaluated.   "
140541|NCT01444989|"     Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh     colored to erythematous, these lesions often present with scaling or crusting in sun damaged     regions of the body. While they are physically visible and often palpable, these changes can     also result in psychosocial changes in patients, including embarrassment about their skin or     reduction in leisure activities to avoid further sun exposure. At the same time, AKs are     known to progress in a significant number of cases to squamous cell carcinoma (SCC), a     concern in terms of its metastatic potential.      The primary purpose of developing this questionnaire is to examine how well it can     potentially identify patients with actinic keratoses. However, since AK is associated with     significant detriment to quality of life for validity/reliability assessment, the     investigators propose to give a compilation of four self-assessment questionnaires (not     specific to AK but validated for skin health in general) to subjects with at least one     actinic keratosis and age- and sex- matched participants without AKs, defined as the control     population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as     well as a questionnaire composed of items specific to predisposition to AKs to be able to     better assess the discriminatory power of the questionnaire.   "
140542|NCT01444976|"     There is no ideal sedation technique that can be used during Transesophageal Echocardiography     (TEE), and the data concerning the effects of available sedation techniques on Heart Rate     Variability (HRV) are limited. In this study the investigators aimed at comparing the effects     of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.   "
140543|NCT01444924|"     This study is a single-center, randomized, placebo-controlled, double-blind clinical trial.     The purpose of this study is to evaluate the impact of pre-operative transverses abdominis     plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for     gynecologic cancers.   "
140544|NCT01444911|"     This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™     Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water     based lubricant, on sexual dysfunction, compared to the current standard care for women with     no evidence of disease after treatment for gynecologic cancers.      In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients     are generally asked about sexual function. Those women who report sexual dysfunction will be     given the option to enroll in the study. After enrollment, the Female Sexual Function Index     (FSFI) and other quality of life surveys will be administered at baseline. The participants     will be randomized to either the control arm, composed of standard of care therapy for the     physical components of sexual dysfunction, or the experimental arm (VRP).      Throughout the study, the participants will undergo physical exams to assess the rate of     improvement in their comfort with pelvic exams and changes in vaginal length. They will also     be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of     Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of     improvement in sexual function and quality of life.   "
140545|NCT01444898|"     Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a     major source of morbidity and mortality in this population. It can lead to sleep apnea, cor     pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set     it apart from other forms of obesity including insatiable appetite and food-seeking behavior     which can be disruptive to home and school activities, and can cause severe social and     psychological turmoil within families. PWS is also associated with unique hormonal     abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the     stomach that stimulates food intake during a fast. It is hypothesized that the extremely high     ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite.     Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears     to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like     peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric     emptying, among other effects. In the present study, the investigators will investigate the     effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators     will quantify the changes in weight and body composition, as well as subjective measures of     appetite, and concentrations of appetite-associated hormones. The investigators hypothesize     that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels     during the treatment period.   "
140550|NCT01444833|"     It is supposed that the significant metabolic effects (improvement of insulin sensitivity) of     hypertension therapy with renin-angiotensin system (RAS) blockers in humans are mediated     mainly via changes in abdominal adipose tissue. This project is aimed to confirm the     hypothesis that increased concentrations of circulatory angiotensin II after angiotensin II     receptor type I (AT1) blockade leads, via stimulation of angiotensin II receptor type II     (AT2), to activation of adipogenesis and improvement of insulin sensitivity. Therefore, in     hypertensive patients, the components of RAS and the parameters of insulin sensitivity on     systemic (in plasma) and local (in adipose tissue and in its interstitial fluid) level will     be studied. The main aim of the study is to identify the changes occurring in patient before     and 6 months after the conversion of therapy from angiotensin converting enzyme (ACE)     inhibitors to AT1 receptor blockers. Observed parameters will include gene expression of RAS     components, parameters of insulin sensitivity, amount, and cellularity of adipose tissue     obtained by biopsy, evaluation of direct production of cytokines and angiotensins into the     interstitial fluid of fat tissue obtained by microdialysis and evaluation of the selected     parameters in plasma.   "
140609|NCT01444066|"     The goal of our study is to determine if stretching the esophagus with a rubber dilator helps     patients with swallowing difficulties who have a normal appearing esophagus on upper     endoscopy. In order to do this we will perform a randomized controlled study, where patients     will undergo esophageal dilation (stretching) with different diameter dilators. We will     measure change in symptom severity between baseline (prior to dilation) and 1, 3, 6 and 12     months after the procedure   "
140551|NCT01444820|"     In North America, around a quarter a million men are diagnosed with prostate cancer every     year, and about 31,000 patients will die of their disease each year. Like other western     countries, the incidence in Canada has increased due to an aging population and prostate     specific antigen (PSA) screening. This has led to a significant demand on cancer care     services for these patients. Prostate cancer patient with high risk features are more often     treated with external beam radiation therapy (EBRT) plus two to three years of hormonal     manipulation (luteinizing hormone-releasing hormone [LHRH] agonist). The most common     radiation dose treatment for these patients is 74-78 Gy in 37-39 daily fractions of 180-200     cGy for a treatment length of 7.5 weeks. This fraction size is believed to offer the best     balance between desired tumour kill and unwanted normal tissue injury. Larger fraction sizes     of more than 250 cGy (hypofractionation) are usually avoided for curative therapy because     late reacting normal tissues. However prostate cancer cells have a unique radiobiology     characteristic that suggests that hypofractionated radiotherapy is more efficient at prostate     tumour killing than standard fractionation is, and will produce equivalent tumour control     with a lower total dose and a shorter overall treatment time. Improved target localization     techniques and conformal radiation therapy technology have allowed for dose escalation and     hypofractionated radiation delivery in these circumstances with minimal or no increased     toxicities.      This trial is designed to determine whether high risk prostate cancer patients can be safely     treated with a dose escalation hypofractionated radiation therapy in 5 weeks as opposed to     the usual 7-8 weeks. These patients will be randomized to either the usual 76 Gy in 38     fractions or 68 Gy in 25 fractions. 3D-Conformal Radiotherapy (3D-CRT) or Intensity Modulated     Radiotherapy (IMRT) will be used to deliver the required radiation dose. Patients will also     receive 28 months of androgen deprivation therapy (LHRH agonist). The primary outcome of the     study is the acute and delayed toxicity and the secondary outcomes include biochemical     failure, prostate specific mortality rate, bone metastases free survival, the prognostic and     predictive value of several biological variables: presence of the PTEN deletion; expression     of FoxP3 gene variants, topoisomerase 2α and cancer testis antigens; expression of X     chromosome-linked micro-RNAs; presence of TMRSS2-ERG gene fusion and quality of life. It is     planned to recruit 250 patients to this study.   "
140552|NCT01444807|"     Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to     metastasectomy   "
140553|NCT01444794|"     The purpose of the protocol is to assess the responder rate as defined by the achievement of     the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A)     injection cycle in accordance with routine practices.   "
140554|NCT01444781|"     This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722).     The objectives are:        -  To describe the antibody persistence to any antigen contained in the investigational          DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose        -  To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep          B-PRP-T or Infanrix hexa™ vaccine.        -  To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.   "
140555|NCT01444768|"     This study will evaluate various performance metrics of emergency department operations after     the implementation of computerized physician order entry in an academic emergency department.   "
140556|NCT01444755|"     The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen     in patient with resectable locally advanced gastric cancer in comparison with surgery alone.   "
140557|NCT01444742|"     The goal of this clinical research study is to learn if clofarabine when given in combination     with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could     not be controlled with standard therapy. The safety of this treatment will also be studied.      Clofarabine is designed to interfere with the growth and development of cancer cells.      Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer     cells and stop the DNA from repairing itself.   "
140558|NCT01444729|"     An agreement has been made to conduct a post-approval commitment study that provides     supplementary information relating to the use of Xiapex® as well as other non-pharmacological     treatments for Dupuytren's contracture by health care professionals in a real world clinical     setting.   "
140559|NCT01444716|"     The goal of this clinical research study is to learn if ofatumumab can help to control CLL.     The safety of this drug will also be studied.      Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the     leukemia cells to die.   "
140560|NCT01444703|"     The investigators propose to test the hypothesis that pre-operative gargling with licorice     reduces the incidence of sore throat in rest after intubation with double-lumen endotracheal     tubes compared to placebo after surgery through the first four post-extubation hours.   "
140561|NCT01444690|"     The purpose of this study is to assess the efficacy and tolerability of orally administered     dimiracetam for 10 weeks to AIDS patients under treatment with antiretroviral agents     presenting a disease and /or treatment related neuropathic pain.   "
140562|NCT01444677|"     The purpose of this study is to investigate the safety and tolerability of MB12066 after a     single or multiple oral dose and to investigate the pharmacokinetic characteristics of     MB12066 after a single or multiple oral dose.   "
140563|NCT01444664|"     The purpose of this prospective registry is to determine if patients harboring intracranial     aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and     blood plasma.   "
140564|NCT01444651|"     The purpose of this study is to find out if tadalafil can help overweight and obese people     metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day     of tadalafil for 3 months is safe to take without causing too many side effects. The     investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).   "
140565|NCT01444638|"     Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not     have pre-spinal ultrasound examination of their back.   "
140577|NCT01444482|"     The safety of parenterally administrated investigational vaccine (commercial influenza     vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly     (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters     associated with improved protection against clinical disease in elderly. Such parameters     include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune     response.      Vaccination will start in 22 healthy adults receiving the investigational vaccine.     Vaccination of elderly will be initiated only after demonstration of safety in adults. 88     healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza vaccine     alone and 44 will receive the investigational vaccine. Vaccines will be administrated     intramuscularly in the upper arm. One dose will be administered to each volunteer included in     the study. Blood samples for basic immunological assessments of cellular and humoral immunity     will be taken at day 0, 7, 28, 90 and 150.      The investigational vaccine is equal to one standard human dose of a commercial seasonal     influenza vaccine to which 50 µg of adjuvant Matrix M has been added.   "
140567|NCT01444612|"     Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism     (PE), is a common post-operative complication. The effectiveness of fondaparinux compared     with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery     has been evaluated in database studies; however, the effectiveness of injectable     anticoagulant medications following cancer-related surgeries in the practice setting has not     been as well documented.      The objective of this study is to analyze patient records from a national hospital database     and compare the outcomes and costs between four types of injectable anticoagulant medications     that were prescribed for the prevention of VTE following cancer-related surgery. This     analysis will assess and quantify the outcomes, resource utilization, and cost of care for     patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The     outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource     utilization, and total costs (medical plus pharmacy).      The source of data for this study is the Premier Perspective Database™. This hospital claims     database links de-identified inpatient medical, pharmacy, and billing data from more than 500     hospitals.      This study is a retrospective cohort study that uses propensity score matching to adjust for     the differences between the numbers of patients treated with each medication.   "
140568|NCT01444599|"     Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS)     is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap     fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined     with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS.     Fractional flow reserve (FFR) is an established index of the physiological significance of a     coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable     clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional     severity of CAD. Few studies reported relevance between two tests. Aim of this study was to     investigate whether the geometry and composition of lesions were different under FFR     criteria.   "
140569|NCT01444586|"     This is a local, prospective, multicenter, non-interventional, observational study. Primary     objective is to describe how in real life thromboprophylaxis is carried out after the     discharge from a hospital in the patients who undergo elective knee and hip replacement and     who receive Xarelto during hospitalization.   "
140570|NCT01444573|"     The investigators hypothesized that very lenient rate control is not inferior to strict or     lenient rate control assessed by implantable continuous ECG monitor for preventing     cardiovascular hospitalization and mortality in patients with long-standing persistent or     permanent atrial fibrillation   "
140571|NCT01444560|"     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of     complementarity. miRNAs have recently been shown to play pivotal roles in diverse     developmental and cellular processes and linked to a variety of skin diseases and cancers. In     the present study, the investigators examines the expression profiles of miRNA machinery     components such as miRNA maturation and transport factors, microprocessor complex and RISC     subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.   "
140572|NCT01444547|"     The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy     with cisplatin and paclitaxel in esophageal cancer   "
140573|NCT01444534|"     The use of smartphones has increased substantially in recent years. Apart from making phone     calls and sending short messages, these smartphones can also function as a computer on which     one can download computer programs (the so-called applications). Health applications are     increasingly developed and may be a new tool for education of patients and communication     between healthcare providers and their patients, possibly contributing to a better care for     patients with chronic diseases such as diabetes.      Since the number of patients with diabetes mellitus and the number of people having a     smartphone are rising, it is investigated whether applications on smartphones may be used to     support lifestyle changes and self-monitoring of bloodglucose control, possibly leading to an     improved glycaemic regulation in the group of patients with diabetes mellitus.      Large randomized controlled trials have shown that a stable glycaemic regulation is important     to reduce morbidity and mortality and to improve quality of life (QOL). Self-monitoring of     blood glucose is an important tool to realize an optimal glycaemic regulation in patients     with type 1 diabetes mellitus (T1DM). Apart from a good glycaemic control, QOL is essential     in diabetic patients. A reduced QOL is associated with progression of the disease, worse     intake of medication and an increased mortality in patients with T1DM and diabetes mellitus     type 2.      The increasing costs associated with the rising number of diabetic patients makes that     research investigating cheaper alternatives in the care for patients with diabetes are     needed. The switch from a written logbook to an electronic logbook may simplify the care for     diabetes patients. By means of an application all variables (food intake, physical exercise,     glucose day curves, insulin units, reminders to take medication) are integrated in one     program. But whether this digitalisation also improves QOL of the patient is still unclear.      Therefore the aim of this study is to evaluate the effect of a diabetes application on the     (QOL) for type 1 diabetic patients.   "
140574|NCT01444521|"     The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy     with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal     dosage of combination chemotherapy.   "
140575|NCT01444508|"     In order to reduce bloodloss and need for transfusion to investigate the effect of colloid     and crystalloid on coagulation assuming no difference between the groups.   "
140576|NCT01444495|"     The purpose of this study is to establish the influence of time-interval between preoperative     hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years),     local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical     resection rate (R0) in patients with locally advanced rectal cancer operated on according to     TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents     are evaluated to assess response to radiotherapy.   "
140602|NCT01444157|"     When facing life threatening illness such as advanced cancer palliative care is needed to     improve quality of life of patients and their families through the prevention and relief of     suffering. Palliative care at an early stage prevents the development of problems and     symptoms, but time, resources and experience are needed in the primary care sector in Denmark     to deal with the problems families experiencing life with advanced cancer are facing. The     aims of this study are to test, evaluate and further develop interventions that can help     identify and assess problems, resources and opportunities of families experiencing life with     advanced cancer, and on this background to help the families cope with their situation in     cooperation with healthcare professionals to an extent where the family's quality of life     increases, their physical and psychosocial problems are relieved, their symptoms of anxiety     and depression are reduced, family satisfaction with health professionals are increased and     acute readmissions to hospital are prevented.   "
140578|NCT01444469|"     Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in     asthmatic patients. Current treatments for asthma attacks are not completely effective and     new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung     infections have also been associated with asthma attacks. However, the role for bacteria is     uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not     recommend the routine use of antibiotics. The investigators would like to investigate whether     or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that     has been used for many years in the treatment of respiratory disease, might be of benefit in     asthma attacks. As there is some evidence that azithromycin has anti-viral properties this     may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect     of azithromycin on asthma attacks this will help us to show whether or not azithromycin     should be recommended during an acute asthma attack in addition to the usual care that is     provided to these patients as it may help them recover quicker from the exacerbation. The     investigators will also be able to look at why azithromycin may be effective - if it is     having an anti-bacterial and/or anti-viral effect.   "
140579|NCT01444456|"     This is a multicenter, international, prospective, observational study of patients who are     receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian,     prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are     receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to     treat symptomatic anaemia.      Quality of Life will be assessed electronically with the aim of estimating improvement in     quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an     increase in haemoglobin (Hb) of ≥1 g/dL   "
140580|NCT01444443|"     The objective of this in-clinic study is to test our closed-loop glucose control system in     patients with type 1 diabetes.   "
140581|NCT01444430|"     The purpose of the study is to evaluate the safety of Symbicort compared to inhaled     corticosteroid alone during 6 months in adult and adolescent patients with asthma   "
140582|NCT01444417|"     The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of     thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured     by durable platelet response.   "
140583|NCT01444404|"     First in human, open-label, sequential dose escalation and expansion study of AMG 820 in     subjects with advanced solid tumors.   "
140584|NCT01444391|"     The objective of the study is to evaluate the safety and efficacy of the Acclarent     Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under     local anesthesia delivered by iontophoresis in an office/clinic setting.   "
140585|NCT01444378|"     To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent     System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of     subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral     artery (SFA) and/or the native proximal popliteal artery (PPA).      CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL     Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal     (U.S.) law to investigational use only.   "
140586|NCT01444365|"     To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal     Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of     the knee.   "
140587|NCT01444352|"     This study is designed to evaluate the safety, tolerability, and immunogenicity of an     investigational pneumococcal vaccine in healthy adult volunteers.      Primary Objective:        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.      Observational Objective:        -  To evaluate the immunogenicity of an investigational Pneumococcal vaccine.   "
140588|NCT01444339|"     This study is designed to evaluate the safety, tolerability, and immunogenicity of two     investigational pneumococcal vaccines at three dose levels in healthy adults.      Primary Objective:      - To evaluate the safety and tolerability of two investigational pneumococcal vaccines.      Observational Objective:      - To evaluate the immunogenicity of the investigational pneumococcal vaccines.   "
140603|NCT01444144|"     The purpose of this study is to track surgical outcomes and post-operative course in patients     55 years of age or older treated for ankle fractures.   "
140604|NCT01444131|"     The purpose of this study is to test whether the addition of a nicotine patch to varenicline     increases smoking cessation success rate and whether the combination is safe.   "
140605|NCT01444118|"     The vaccine contains humanized recombinant antigen (Epithelial Growth Factor) and an     adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to     removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is     prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation     of tumour cell. A Phase III clinical trial on the EGF vaccine is ongoing in Cuba. The result     from previous studies demonstrated positive correlation between extended survival and immune     response against the vaccination in the late-stage NSCLC patients' age below 60 with improved     quality of life. The purpose of this international Phase III trial is to determine whether     the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment     of stage IIIB/IV NSCLC patients compared to standard treatment and supportive care.   "
140608|NCT01444079|"     Liver is an organ that is well-known for its immune tolerant capacity. However, there were     still controversial issues about the impact of immunologic challenge after liver     transplantation on the graft function. Different results of graft function affected by     immunologic factors such as pre-transplant panel reactive antibody (PRA) status,     pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor     specific antibody (DSA) has been reported according to individual institutes. There was no     trial for presenting anti-donor lymphocyte antibody change after liver transplantation.      The investigators designed this study to analyze the correlation between pre- and     post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the     investigators will find aspects of anti-donor lymphocyte antibody change after liver     transplantation.   "
140610|NCT01444053|"     The purpose of this study is to examine the long term effect of ultra-violet filtering     contact lenses on macular pigment density (MPOD) and accommodative function.   "
140589|NCT01444326|"     Inflammation and endothelial dysfunction are being increasingly recognized as key etiological     factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD).     These pro-atherogenic states are strongly correlated and often found co-segregating among     individuals with obesity and the metabolic syndrome. There is increasing evidence to support     the use in clinical practice of these novel markers of atherosclerosis and CVD risk. Recent     data from the JUPITER study (Justification for the Use of Statins in Primary Prevention: An     Intervention Trial Evaluating Rosuvastatin) has provided undisputable evidence that treating     patients with elevated plasma CRP concentrations, a marker of systemic subclinical     inflammation, leads to marked reduction in the risk of CHD even in patients with highly     desirable LDL-C levels. There is also accumulating evidence associating endothelial     dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to     an increased risk of CVD. While there are more and more studies on how diet affects     inflammation and endothelial function, the impact of dairy consumption per se on these novel     risk factors for CVD has not been well characterized.      The purpose of this study was to investigate the impact of dairy consumption on markers of     inflammation and other risk factors in men and women with low grade systemic inflammation.   "
140590|NCT01444313|"     The purpose of this study is to examine the short-term protective effect of Ultra-Violet     filtering contact lenses on macular pigment ocular density.   "
140591|NCT01444300|"     Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in     people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages     the myelin insulation around nerves which slows conduction of messages from the brain to the     leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin.     Recent research indicates that imbalance in MS is in large part caused by poor conduction by     the nerves that transmit information about the position of the legs to the brain. It is     therefore likely that, by improving nerve conduction, dalfampridine will also improve     imbalance in people with MS. Dalfampridine will be administered in this study by the same     route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve     walking speed in people with MS. The proposed pilot study will examine the effects of     dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This     small pilot study will help to show if dalfampridine improves imbalance in MS and will guide     the design and implementation of a larger full scale study to definitively determine if     dalfampridine improves balance and prevents falls in people with MS.   "
140592|NCT01444287|"     The purpose of this research is to measure daytime open-eye response to wearing of narafilcon     B lenses.   "
140593|NCT01444274|"     This will be an observational, prospective, non-randomized, pilot study to gain initial     device experience on a novel space-occupying device in persons who are overweight or obese.     No formal hypothesis testing will be conducted.   "
140594|NCT01444261|"     With early screening and appropriate iron supplementation, iron deficiency in the first year     of life can be prevented in breastfed infants.   "
140595|NCT01444248|"     The study design of this trial is open-label, randomized, multi-center, parallel-group study.   "
140596|NCT01444235|"     Comparison of the cardioprotective effects and safety of two cardioplegic solutions     (solutions used during a cardiac arrest in the heart surgery) in patients undergoing     cardiopulmonary bypass for coronary artery bypass surgery.   "
140597|NCT01444222|"     Right-sided heart disease has an important impact on the prognosis of patients with valvular     heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics     have not been extensively investigated. However, it is plausible that a significant degree of     TR and the associated volume-overload of the right ventricle cause significant right     ventricular wall stress. Although minor TR generally is well tolerated, major TR can lead to     clinical symptoms, right ventricular dilatation and ultimately right ventricular heart     failure. Up to now, the investigators do not dispose of any tools to diagnose and anticipate     this unfavourable evolution. Nevertheless it is likely that right ventricular failure is     preceded with a subclinical dysfunction of the right ventricle and a possibly reversible     change in contractility of the myocardium.      Recently, new techniques to evaluate the systolic function, the contractility and the     hemodynamics of the heart have become available.      First, this study will help us assessing the feasibility and accuracy of several imaging     modalities in right-sided heart pathology with focus on TR and right heart myocardial     performance.      Second, this study will contribute to a better understanding of the hemodynamic effect of     volume-overload and/or pressure-overload of the right ventricle. It will clarify the     behaviour of TR, the evolution of right ventricular myocardial contractility and dysfunction     during exercise and its impact on exercise capacity. By doing this, discrimination between     well tolerated and ill-tolerated TR will be possible, thus identifying patients who might be     eligible for treatment (medical, corrective, …).   "
140598|NCT01444209|"     This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo     implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor     response to treatment will be monitored as well as change in visual fields, associated     adverse effects, progression free survival and patient reported outcomes.   "
140599|NCT01444196|"     The primary objective of the study is to assess the dosis of DL which is sufficient to     inhibit cold urticaria symptoms.   "
140600|NCT01444183|"     The study will examine whether a stress reduction intervention reduces the number of seizures     in people with drug resistant epilepsy. In the proposed randomized controlled, double blind     trial, the investigators will enroll subjects with frequent seizures, especially those who     identify stress as a seizure precipitant. There is an observational phase (8-12 weeks) and a     treatment phase (12 weeks). During the observational phase, subjects will be monitored     multiple times daily via smart phone devices, in order to identify high risk days for     seizures. In the treatment phase, subjects will be randomly assigned to one of two groups     receiving different focused attention practices. These behavioral interventions will be     administered daily with extra interventions applied on days of higher risk.   "
140601|NCT01444170|"     The objectives of this study are to assess the effectiveness of a nutritional supplement on     muscle functional recovery following induced muscle damage from high intensity resistance     exercise. The investigators hypothesize that a short-term dietary supplementation will     significantly improve muscle functional recovery following an intense bout of eccentric     exercise compared to a placebo.   "
140612|NCT01444027|"     In recent years, the demand for home hospice care has grown rapidly. Family members and     friends who act as informal caregivers are essential to the provision of palliative care     services; however, this role is not without adverse effects on the caregivers themselves. It     is well documented that emotional needs of individuals caring for dying persons in their home     are not well attended, and interventions aiming to provide support to informal hospice     caregivers are notably lacking. In this context, problem solving therapy (PST) provides an     overall coping process that fosters adaptive situational coping and behavioral competence.     The investigators are conducting a randomized controlled trial to fully evaluate the PST     intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate     how the modality of the intervention (face to face vs video) impacts its effectiveness. This     investigator team is conducting a 4-year randomized trial study in which hospice caregivers     will be randomly assigned to a group receiving standard hospice care with the addition of     social support interactions (attention control group) or a group receiving standard hospice     care with the addition of the problem solving intervention delivered face to face     (intervention group 1) or a group receiving standard hospice care with the addition of the     problem solving intervention delivered via video (intervention group 2). The specific aims     include an assessment of the impact of PST on caregiver quality of life, problem solving     ability, and caregiver anxiety.   "
140613|NCT01444014|"     The aim of the study is to find out if the experimental medicine, YF476, can make gastric     carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur     mainly in patients with chronic atrophic gastritis (CAG), a condition in which the     acid-producing cells in the lining of the stomach can't make acid. Acid production is     controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream.     If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin in     patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and,     over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign,     but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the     inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids     need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a     mini video camera, which enables the user to inspect the lining of the stomach and a 'snare'     to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor antagonist     (blocks the effects of gastrin), so it's a potential new medical treatment for gastric     carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily for up to     12 weeks. They'll make up to seven outpatient visits for tests, including checks on the     safety of YF476 and up to four gastroscopies. At each gastroscopy, the gastric carcinoids     will be measured and biopsies taken for laboratory tests. Patients will take up to 24 weeks     to finish the study.   "
140614|NCT01444001|"     This study was designed to evaluate the safety, tolerability, and immunogenicity of three     doses of an investigational pneumococcal vaccine in healthy adult volunteers.      Primary Objective:        -  To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.   "
140615|NCT01443988|"     Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus     medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative     glaucoma, or ocular hypertension naïve to medical and surgical therapy.   "
140616|NCT01443975|"     The purpose of this study is to clinically evaluate the use of the x-pander device.   "
140617|NCT01443962|"     During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen     saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory     parameters include oxygenation. So applying PEEP could improve the regional brain oxygen     saturation (rSO2)   "
140627|NCT01443832|"     The study sought to investigate the effect of lowering phytic acid in fonio porridge with     phytase activity naturally occurring in wheat flour on iron absorption using labelled stable     isotopes of iron. The study population is represented by 16 apparently healthy young Beninese     women aged 18-30 years recruited based on their willingness to participate and according to     inclusion criteria. Test meals consisted of fonio porridges fortified with isotopically     labelled [57Fe] or [58Fe] ferrous sulfate with and without wheat flour. Meals were     administered to fasting subjects on two consecutive days using a randomised crossover design:     half the subjects received the test meal on the first day and the control on the second day     and vice versa. Venous blood sample were collected (day 1 and day 14) for iron status and     iron absorption measurement. Iron absorption measurement is based on erythrocyte     incorporation of iron stable isotope labels 14 days after intake of the labelled test meals     and calculated based on isotope-dilution.   "
140618|NCT01443949|"     Background:      - The risk for becoming addicted to drugs varies from person to person, even among those who     use similar drugs in a similar way. Studies suggest that certain personality traits seen in     people with drug addiction may be present before drug use. These traits include responding     differently to rewards or impulsivity. Early use of drugs (before age 15) is also associated     strongly with drug addiction later in life. Researchers want to study teenagers with and     without certain behavioral problems, including those who have used drugs and those who have     not. This may help them better understand behaviors that might predict future drug addiction.      Objectives:      - To understand brain function in teenagers who may be at a higher risk than others to drug     addiction.      Eligibility:        -  Teenagers between 13 and 17 years of age who fit into one of four groups:        -  Have never or rarely used drugs        -  Have never or rarely used drugs and have conduct or behavior disorders        -  Have used drugs on many occasions        -  Have used drugs on many occasions and have conduct or behavior disorders      Design:        -  Participants will be screened with a medical history, and physical and neurological          exams. They will also have blood and urine tests. Participants will answer questions          about past drug use and any current medications. They will also have a breathalyzer and          carbon monoxide breath test to check for recent drug and alcohol use.        -  This study requires four visits to the clinical center for magnetic resonance imaging          (MRI) scans and other tests.        -  The first study visit will include training for the MRI scans. Participants will          practice the tasks in front of a computer and in a mock (fake) MRI machine. Participants          will also be asked several questions about their personality and past experiences.        -  Researchers will test changes to tryptophan and dopamine levels. Both of these chemicals          affect decision making and brain function. On the three study visits, participants will          have the following tests in a randomly selected order. One study will be done at each          visit.        -  MRI scans with changes to dopamine and tryptophan levels        -  MRI scans with changes to dopamine only (with placebo)        -  MRI scans with changes to tryptophan only (with placebo)        -  Participants will be monitored with frequent blood draws and other tests during the          study visits.   "
140640|NCT01443663|"     H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study     will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have     previously received one of two versions of an H5N1 vaccine or have previously received an     H7N3 vaccine and in people who have not previously received any live attenuated influenza     vaccine (LAIV).   "
140619|NCT01443936|"     This is a Phase 1 randomized, single center, dose-escalation study designed to evaluate the     safety and immunogenicity of live, replication competent recombinant Adenovirus type     4-H5N1Influenza Vietnam 1194 Hemagglutinin (HA) (Ad4-H5-Vtn). Determining the optimal route     and dose for this recombinant platform will greatly accelerate investigations of this vector     as an influenza vaccine and an HIV vaccine platform.      Intranasal and tonsillar administration of the vaccine will be separately assessed. The oral     enteric-coated capsule will also be assessed in 10 outpatients using similar blood sampling     for comparison. The Ad4-H5-Vtn orally administered as enteric-coated capsules has already     been evaluated in an ascending dose Phase 1 study, in dosages as high as 10(11) viral     particles (vp).      The primary goal of this study is to evaluate safety of ascending dosages of the Ad4-H5-Vtn     vaccine following intranasal and tonsillar administration. A dosage or dosages will be     selected to further evaluate the humoral, cellular, and mucosal immune responses against both     the vector and the inserted gene. The Ad4-H5-Vtn will be initiated at 10(3) vp. Once safety     is established at the initial dose, a second round of testing will begin at the next ten-fold     higher dose. The Ad4-H5-Vtn vaccine will be assessed in three participants at each dosage     level. The maximum viral dose administered by the tonsillar route will be 10(8) vp.      In addition to clinical and laboratory monitoring of safety, the principal assessments will     be shedding of the Ad4-H5-Vtn virus in rectal, cervicovaginal, throat, and nasal swabs, and     assessment of the antibody (mucosal and systemic) response to the HA and to the Ad4 virus.     When safety has been confirmed in all three participants at a given dosage level, the next     higher dose group is enrolled. If one grade 3 or greater toxicity (or pre-specified Grade 2     toxicity, see Section 3.4) attributable to the vaccine is observed, the group will be     expanded at that dose. If a second attributable grade 3 or greater toxicity (or pre-specified     Grade 2 toxicity, see Section 3.4) is observed, the dose will be reduced one level and the     group will be expanded. Up to 25 Ad4-seronegative individuals will be enrolled at the maximum     tolerated dose to fully evaluate safety and immunogenicity in the protocol.      All participants will be followed for 28 days following immunization, and again at 8 and 26     weeks to evaluate any long-term toxicity and persistence of immunity. Tonsillar Participants     will receive a booster dose of vaccine [SK1]at the 26-week visit and be seen for follow-up     visits at Weeks 30 and 34. Household and intimate contacts will also be enrolled and     monitored for Adenovirus and HAI antibodies.   "
140620|NCT01443923|"     Background:      - Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN     and ribavirin. However, this treatment is not very effective in people with a serious type of     HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV)     coinfection. Researchers want to add a new drug, boceprevir to see if it can improve     treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination     with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV     genotype 1 infection only, and is currently being studied in those with HIV and HCV.      Objectives:      - To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with     HCV monoinfection compared to those with both HIV and HCV infections.      Eligibility:        -  Individuals at least 18 years of age who have HCV genotype 1 infection, and have not          received interferon treatment for HCV        -  Half of the study participants will also have HIV infection.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood and urine tests.        -  Participants will also have heart and liver function tests, and answer questions about          mood and depression.        -  Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to          inject under the skin weekly.        -  Two weeks after starting treatment, participants will have blood tests to study the          treatment.        -  Four weeks after starting treatment, participants will start taking boceprevir three          times a day.        -  Participants will have regular study visits with blood samples and other tests. The          length of therapy will depend on the level of virus detected in the blood at several          clinic visits. Those who do not respond well to the medicines at 12 weeks will stop          treatment. The full length of treatment is 48 weeks.   "
140621|NCT01443910|"     This study is part of an effort to learn about interactions between doctors and patients. We     aim to understand how women feel about techniques that doctors use to talk with patients     about their weight. We are studying women s reactions to these techniques using a virtual     reality version of a doctor s office to create as realistic a model of a doctor s visit as     possible. This can help us better understand what happens during real doctor s visits.      Women between the ages of 20 and 50 who are currently overweight may be eligible for this     study. Participants will be recruited from the Washington D.C. area. This is not a weight     treatment study.      Participants undergo the following procedures:        -  Complete an online questionnaire about themselves, their experiences, and their thoughts          about their weight        -  Participate in activities in a virtual reality environment in which they interact with a          virtual doctor in a virtual clinical scenario. For this experiment, participants wear a          head-mounted display that allows them to see the virtual world images.        -  Fill out a questionnaire after completing the virtual reality activities. This          questionnaire includes information on the participants' virtual reality experience, the          information provided in the experience, and additional questions about themselves and          their thoughts.   "
140622|NCT01443897|"     This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase     their vitamin D2 content are actually a good source of vitamin D when consumed daily with a     meal (lunch). The mushrooms will be provided cooked along with a meal which will be a     standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in     vitamin D status affects the immune system by decreasing it's level of activation, which may     be abnormally elevated in vitamin D deficiency.   "
140623|NCT01443884|"     The goal of the study is to determine whether grape consumption can reduce the risk of     cardiovascular disease by reducing the presence of inflammatory molecules and positively     altering cholesterol levels, lipid profiles, and immune cell responses.   "
140624|NCT01443871|"     The purpose of this study is to examine and compare electroencephalography (EEG) changes in     human subjects directly after inhalation of essential oils from five Thai aromatherapies. The     investigators hypothesize that essential oils from Thai aromatherapies may influence the     human EEG involving emotional relaxation particularly alpha wave EEG.   "
140625|NCT01443858|"     The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent     or treat motion sickness, can help smokers quit smoking. This study will also investigate the     potential relationship between genes you have inherited and success in quitting smoking.   "
140626|NCT01443845|"     To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination     (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.   "
140628|NCT01443819|"     The purpose of this research study is to look at two of the common forms of treatment for     this condition: physical therapy and epidural steroid injection. The investigators are     attempting to evaluate whether or not physical therapy alone, or epidural steroid injections     alone, are effective in treating this condition. The investigators will also try to determine     whether or not one of these treatments is better than the other for the treatment of     herniated discs with nerve injury (radiculopathy).   "
140629|NCT01443806|"     The aim of this study is to evaluate the conversion of OP to OC in individual X and the     family member of individual X. The investigators hypothesize that one or more of the single     nucleoprotein polymorphisms (SNPs) of the CES1 gene represent a clinically important     functional polymorphism.   "
140641|NCT01443650|"     Primary Objective:      Injection Site Tolerability      Secondary Objectives:        -  To assess the safety profile of alirocumab SAR236553 (REGN727)        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553          (REGN727)   "
141134|NCT01437189|"     The aim of this open-label, self-control study is to evaluate the efficacy of sertraline in     treating depression in Patients with Parkinson's disease. In addition, the investigators also     want to find out whether patient gets better quality of life when depression is improved.   "
140630|NCT01443793|"     The objective of this active surveillance study is to make available crucial data about     epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility of     nasopharyngeal strains of Streptococcus pneumoniae carried in the population of healthy     children aged less than years and living in the area of Milan and surroundings, Lombardy,     Italy.        -  To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus          pneumoniae in healthy children aged less than 5 years living in the area of Milan,          Italy;        -  To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae          strains in healthy children aged less than 5 years      Secondary objectives:        -  To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains          in healthy subjects less than 5 years old;        -  To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in          healthy children;        -  • To evaluate the possible impact of vaccination policy in the referenced population.   "
140631|NCT01443780|"     The dietary supplements selenium and Q10 has been evaluated in a double blind     placebo-controlled study in an elderly Swedish population. The hypothesis is that as a     majority of Northern Europeans suffers insufficient levels of selenium that is used by the     cell in the building of at least 25 different enzyme systems in the body, and that the cell     need presence of Q10 in order to produce the selenium containing enzymes, we wanted to     evaluate the effect of a combined intervention of the two supplements in an elderly     population in Sweden. All participants were controlled every 6 months, and the intervention     was 48 months in each participant. Besides blood samples, echocardiography and cardiac     natriuretic peptides were analyzed at start, every 6 months and at end of the study.   "
140632|NCT01443767|"     The purpose of this study is to determine the measuring accuracy of the truly non-invasive     method estimated continuous cardiac output (esCCO) against the reference method pulse contour     analysis of the arterial waveform (Picco) in partial liver resection. esCCO is calculated     using the pulse wave transit time, which is defined as the time between the R-wave of the ECG     and a 30% increase of the differentiated pulseoximetry waveform.   "
140633|NCT01443754|"     The present study is designed as a prospective, single centre, open label, observational     trial.      The study will collect information about the medical care patients receive during their     planned procedure(s). No new testing or procedures will be done.      Patients elected for hybrid revascularization will be asked their written consent to the use     of their personal data.      Left internal mammary artery to the Left Anterior Descending Coronary Artery     (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous     revascularization of the other vessels in the frame of the same hospitalization.      After discharge patients will attend clinic visits at 30 days and 12 months, as per usual     clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic     follow-up will be performed in symptomatic patients, as clinically indicated.   "
140634|NCT01443741|"     Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic control,     hypoglycemia prevention and life quality of diabetics children insulin-dependent treated with     insulin pump.   "
140635|NCT01443728|"     This study aims to answer the question whether oral vitamin D supplementation can decrease     lung complications in children and adolescents with sickle cell disease. Lung complications     are the leading causes of morbidity and of death in sickle cell disease. Infections and     increased inflammation play important roles in the development of the lung problems in sickle     cell disease. Emerging evidence shows that vitamin D helps the immune system to fight     infection and to control inflammation and could potentially help prevent respiratory     complications in patients with sickle cell disease. The investigators hypothesize that oral     vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents     with sickle cell disease, will reduce the rate of respiratory events (infection, asthma     exacerbation and acute chest syndrome) compared to the rate in a group given standard dose     oral vitamin D3, 12,000 IU (0.3 mg) given once a month.      Funding Source - U.S. Food & Drug Administration, Office of Orphan Products Development   "
140636|NCT01443715|"     It is challenging for depressed adolescents and their families to access specialized mental     health services. A viable option is delivering treatment in the primary care clinic (PCC)     setting; however, few effective models are currently available. The overall aim of this study     is to assess in the pediatric PCC, the preliminary acceptability and feasibility of a novel     collaborative stepped care model of treatment for depressed adolescents.   "
140637|NCT01443702|"     The investigators will investigate the safety and effectiveness of an Iranian traditional     medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will     be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in     random order. End points are changes in urinary chemistries and stone burden by Ultra     sonography / CT scan.      It will be used in proven calcium stone forming adults who are not pregnant. This phase is a     double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine     supersaturations, pH and sodium determinations will be collected. Entry and final stone     quantification Ultra sonography / CT scan will be performed. End points will be changes in     urine chemistry/supersaturation and stone quantitative stone volume.   "
140652|NCT01443507|"     The purpose of the study is to compare exercise at 70% of maximal heart rate were total     energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate.     Since 70% of maximal heart rate is well above the minimum threshold for improvements in     maximal oxygen uptake it should be suited to investigate the effect of duration.   "
140653|NCT01443494|"     We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved     sublingual microcirculation.   "
140638|NCT01443689|"     Burn trauma,especially extensive ones, remains a life-threatening local and general     inflammatory condition destroying the skin and underlying tissues, and resulting in serious     sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays     an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and     human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate     the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic     strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs     transplantation will be evaluated in patients with acute burn.   "
140642|NCT01443637|"     The CONFIRM study was developed to examine the prognostic value of cardiac computed     tomographic angiography (CCTA) findings for prediction of future adverse cardiac events     related to coronary artery disease (CAD) in a large, international patient population. The     purpose of this multicenter registry is to correlate coronary and non-coronary cardiac     findings by CCTA with demographic and clinical data for refinement of risk stratification of     individuals with suspected or known CAD.   "
140643|NCT01443624|"     The purpose of this study is to evaluate the pro-oxidant toxicity of iron injections in     critically ill patients and in healthy volunteers. The investigators hypothesize that the     inflammatory state of critically ill patients will reduce the oxydative stress induced by     iron injections, compared to the one induced in healthy volunteers. It will be an open     proof-of-concept study aimed at evaluating iron toxicity in critically ill patients (n=40)     as compared to healthy volunteers (n=40).      The investigators will compare the oxidative stress (principal judgment criteria=     8-iso-PGF2α) following a 100 mg injection of iron (at T0, T2, T6 and T24 hours post     injection) in both groups and the investigators will compare the effect of repeated     injections in the critically ill patients.   "
140644|NCT01443611|"     The actual recommendations for infants aged 3 to 12 months presented with first episode of     Febrile Convulsions highly recommend performing lumbar puncture in order to rule out     Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal     vaccination arise the question if in the presence of a normal physical examination those     recommendations are still relevant. The purpose of this study is to summarized     retrospectively the clinical records of all the infants admitted to the pediatric wards in     the ten years period since 2000 to 2010 in order to record the incidence of Bacterial     Meningitis among infants admitted with the First episode of Febrile Convulsions.   "
140645|NCT01443598|"     HYPID study is an observational and prospective study of patients with interstitial lung     disease and pre capillary hypertension diagnosed by right heart sided catheterization. The     primary aim of the study is to identify prognostic factors.   "
140646|NCT01443585|"     The purpose of the trial is to clinically evaluate the performance of a progressive addition     lens among presbyopic patients.      This evaluation will be done by performing visual tests and collecting subjective information     from subjects wearing the lens which will be manufactured according to personal prescription.   "
140647|NCT01443572|"     Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by     inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to     cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in     BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of     inhalation anesthetic that minimally affects hepatic function is important. Therefore, the     purpose of this study is to compare the postoperative recovery and hepatic function between     desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients     undergoing Kasai operation.   "
140648|NCT01443559|"     Acellular porcine cornea is a valid substitution for human cornea because of its similar     biological structure, corneal superficial curvature and good histocompatibility toward human.     Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar     porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.   "
140649|NCT01443546|"     The project is a randomized, controlled, prospective study of oocyte donors comparing the     safety and efficacy of triggering ovulation using a combination of two drugs—GnRH agonist and     very low dose hCG—versus triggering ovulation with a standard hCG dose alone or a standard     GnRH trigger alone.   "
140650|NCT01443533|"     This study is a randomized controlled trial that will evaluate the impact of a brief     educational script on the method of birth control that women receive at their 6-week     postpartum visit. The one-minute script (LARC script) is given to women in the hospital     during their postpartum admission. It informs patients about long-acting reversible     contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine     device. The investigators hypothesize that women who are randomized to receive the LARC     script will be more likely to report that they are using a LARC method, when queried     immediately after their six-week postpartum visit.   "
140651|NCT01443520|"     Tramadol is an opioid analgesic, which is widely used in the treatment of acute and     neuropathic pain. After oral administration, tramadol is rapidly and almost completely     absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed     by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation     is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral     tramadol with duloxetine and venlafaxine. Duloxetine is known to inhibit CYP2D6. Twelve     healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within     ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study     are plasma concentrations of tramadol and its metabolites.   "
140654|NCT01443481|"     This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at     single-dose and steady state in adult cancer patients either with mild, moderate or severe     hepatic impairment or with normal hepatic function. Hepatic function in study patients will     be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total     bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and     ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by     RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any     other reason.   "
140666|NCT01443325|"     In the present placebo-controlled cross-over study the researchers intend to investigate     analgesic and sensory effects of a lidocaine patch in patients with severe persistent     inguinal post-herniorrhaphy pain.   "
140667|NCT01443312|"     The definition of Thalassemia Intermedia is not generally accepted and the specific clinical     and laboratory characteristics varies between patients. Some patients are blood transfusion     dependent and others are occasionally transfused. Also the mutations in the beta globin gene     are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1     gene can affect the clinical course of this disease. The purpose of this study is to     summarize the characteristics of patients with Thalassemia Intermedia treated at the     Pediatric Hematology Unit at the HaEmek Medical Center in Israel   "
140655|NCT01443468|"     Background:      - Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of     cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may     also increase the risk for certain types of leukemia and other cancers. The only known cause     of LFS is a change (called a mutation ) in a gene known as TP53. However, not all people with     LFS have a TP53 mutation. Researchers want to study other possible genetic causes of LFS, and     factors that may increase or decrease cancer risk in people with the syndrome.      Objectives:        -  To learn more about the types of cancers that occur in individuals with LFS.        -  To study the role of the TP53 gene in the development of cancer.        -  To look for other possible genes that cause LFS        -  To study the effect of LFS diagnosis on families.        -  To determine if environmental factors or other genes can change a person s cancer risk          associated with LFS.      Eligibility:        -  Individuals with a family or personal medical history of cancers consistent with LFS.        -  Individuals with a family or personal medical history of cancers that does not meet the          diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the          so-called Li-Fraumeni like syndrome)        -  Individuals with certain rare cancers        -  Individuals with a family or personal history of a TP53 gene mutation, with or without          related cancer(s).      Design:        -  Participants will fill out a medical history questionnaire and a family history          questionnaire.        -  Blood samples will be collected for DNA and for storage. Cheek cell samples may be          collected if blood cannot be obtained for DNA. Participants can choose to have or not          have cancer screening with blood tests, imaging studies, and other exams.        -  Participants will complete questionnaires about their worries about cancer, stress          levels, and coping strategies. Diet and physical activity questionnaires will also be          given. Other psychological tests may be given as needed.        -  Participants will be monitored for several years, with regular followup visits to the          National Institutes of Health, if indicated. Any changes in health or cancer status will          be recorded.   "
140656|NCT01443455|"     This is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed     entry controls. The interventions have two phases; a 12 week initiation phase with     substantial structure and supervision, followed by a 12 week transition phase, with reduced     structure and supervision. Participants are 168 overweight or obese, sedentary postmenopausal     women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control group.      The following research questions will be assessed:        1. Is exercise adherence at 6 months better with video dance games compared to brisk          walking?        2. Does video dance game exercise compared to wait list controls, induce beneficial changes          in physical and mental health?        3. Does video dance game exercise compared to brisk walking better promote balance,          attention and visual spatial skills, without loss of benefit to cardiovascular fitness?        4. Is video dance preferred to brisk walking for exercise among postmenopausal women? If          so, who and why?   "
140657|NCT01443442|"     Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically,     patients manifest symptoms in the spring, summer and fall, when airborne allergens are at     their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust     mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival     hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and     burning.      This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine     besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the     treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years.     The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms     (itching) will be monitored as outcome variables.   "
140658|NCT01443429|"     The PK and safety profiles to be examined following a single oral administration of     TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to     subjects with normal renal function.   "
140659|NCT01443416|"     This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination     (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called     Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein     called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence     that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used     vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains     only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two     of the three additional serotypes included in PCV-13 which might be enough to protect     children against disease caused by these two serotypes. Furthermore, previous studies have     shown that PHiD-CV confers protection against a common otitis media pathogen in children     called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D,     which is derived from NTHi. In addition, the use of a carrier protein, which is not closely     related to an antigen included in any coadministered or previously administered routine     vaccine minimises the risk of interference related to it.      The investigators aim to recruit 168 healthy children at the age of 12 months who have     already received two doses of PCV-13 according to the UK routine immunisation schedule at 2     and 4 months of age. Participants will then be randomised to receive a booster dose of either     PCV-13 or PHiD-CV at 12 months of age.      Three visits will take place at their parents' home and will involve a blood test followed by     a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month     after visit 1) and 3 (1 year after visit 1).   "
140660|NCT01443403|"     The purpose of this study is to determine efficacy and safety of naldemedine for the     treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving     opioid therapy for ≥ 3 months.   "
140661|NCT01443390|"     When a patient with advanced cancer consults with a member of the Phase I drug development     team, the investigators utilize all information possible to try to select a therapy for that     patient which has the best chance of working for them. This information includes:        1. Past published information        2. Clinical experience and judgement        3. Immunohistochemistry for specific targets (e.g., ER)        4. Standard sequencing (e.g., for K-Ras) and other methods now available.      The investigators have a new tool which warrants early exploration for what role it might     eventually play in the process of selecting the best therapy for an individual patient. The     basis of the current ancillary exploratory study is to gain initial experience with the     operational aspects of this whole genome sequencing in this setting.   "
140662|NCT01443377|"     This study aims to investigate the combination of panitumumab and a 5-FU-based RCTX in     patients with locally advanced KRAS wild-type rectal cancer.   "
140664|NCT01443351|"     Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with     refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for     long-term effects of these drugs. In this observational study, effects and adverse effects     including evaluation of bone marrow biopsies done at fixed intervals will be recorded from     ITP patients treated with TPO-ra. For some patients, blood samples will be collected for     research use.   "
140665|NCT01443338|"     The purpose of this study is to determine whether Triptergium wilfordii, and Acitretin are     effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.   "
140668|NCT01443273|"     There are several factor that can be related to Neonatal Thrombotic events. Among them     hypercoagulability can be the cause of those events. Factor V Leiden (FVL) and Prothrombin     mutation are the most common causes of hereditary thrombophilia. The incidence of in the arab     population is known to be higher than the incidence in another western populations. The     purpose of this study is to review retrospectively the thrombophilic risk factors that were     found in a cohort of premature babies and term newborns treated and investigated at the     Neonatal Intensive Care Unit and at the Pediatric Hematology Unit.   "
140669|NCT01443260|"     The purpose of this study is to determine whether GL-ONC1, an attenuated vaccinia virus, is     safe when administered to patients with peritoneal carcinomatosis via an infusion within the     abdominal cavity through an implanted catheter. The study seeks also to arrive at a     recommended dose and schedule for future investigations, evidence of anti-tumor activity,     detection of virus in body fluids, analysis of viral delivery to tumor and normal cells, and     to evaluate if there is an antibody response to vaccinia virus.   "
140670|NCT01443247|"     The purpose of this study is evaluate the role of anti-d in dengue fever.   "
140671|NCT01443234|"     This research study is designed to investigate the effects of an online computer program,     called OxIGen (Oxford Imagery Generation), on thinking style and mood in depression. The     OxIGen program will be delivered online over four weeks and with follow-up at one, three and     six months. This will inform potential future development of this computerized task into an     online intervention to modify negative thinking styles in depression.   "
140672|NCT01443221|"     To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose     combination of mitiglinide/metformin, compared with free combination of mitiglinide and     metformin in healthy male subjects.   "
140673|NCT01443208|"     To evaluate the pharmacokinetics and safety of single dose and multiple doses of     desvenlafaxine in Korean healthy subjects and compare to westerners.   "
140674|NCT01443195|"     Iron is an essential micronutrient that plays an important role in cellular functions of all     microorganisms. Both iron deficiency and iron excess during the early weeks of life can have     severe effects on neurodevelopment that may persist into adulthood and may not be corrected     by restoration of normal iron levels.      Iron overload remains a significant concern in preterm infants because they have low levels     of iron-binding proteins and immature antioxidant systems.      The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW     Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the     iron supplementation practice for VLBW preterm infants as implemented in the Neonatal     Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.   "
140675|NCT01443182|"     Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural     therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress     disorder (PTSD) following single-event traumas and to be more effective than pure anxiety     management or stabilization treatments. However, much less is known about the efficacy of the     different treatment approaches in survivors of repeated or chronic interpersonal trauma.     Recent evidence suggests that a combination of stabilization treatment + TF-CBT is     efficacious in this population. Although EMDR is also often used in survivors of chronic     interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study     is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a     randomized controlled trial in a routine clinical setting.   "
140676|NCT01443169|"     This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence     cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a     330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro     dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg     market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th     period to to estimate and compare the % of dose absorbed versus time profile for the three CR     prototype tablets and the CR reference tablet.   "
140677|NCT01443156|"     BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and     can lead to many harmful health outcomes such as a higher risk of obesity, heart disease, and     diabetes. Sleep deficiency can also harm cognitive performance, which refers to one's     awareness and thinking ability. Sleep deficiency and sleep-related health issues are of high     interest among those who have irregular and/or extended work schedules, because such     schedules can interfere with normal biological rhythms of sleepiness and wakefulness.      PURPOSE. This study will examine the health and cognitive effects of work schedule and sleep     patterns in caregivers (such as nurses, laboratory technicians, and non-clinical hospital     staff). The investigators hypothesize that the nontraditional, irregular, and extended work     hours common in these professions will have adverse health and cognitive effects. The     purposes of this protocol are to:        -  Enroll caregivers into a one year cohort study on the relationships among work schedule,          sleep, diet, chronic disease, and cognitive performance. (A cohort study follows a group          of participants over time to see how different behaviors or risk factors affect health.)        -  Collect data from caregivers on work schedule, sleep, diet, chronic disease, and          cognitive performance.        -  Give personalized information and feedback to caregivers about these health factors.        -  Educate caregivers about healthy diet and exercise choices.        -  Collect saliva from caregivers for future research on the role of genes in health.          (Specimen collection for genetic testing will be offered as a separate option for study          participants.) RECRUITMENT. This study will use the Let's Get Healthy! health research          and education program (OHSU IRB #3694) as a platform for recruitment and data          collection. Caregivers will be invited to participate in a Let's Get Healthy! event and          will be given information prior to the event about the cohort study. At the Let's Get          Healthy! event, caregivers will first consent to the anonymous research study (OHSU IRB          #3694), in which demographic and health screening data are linked to a random number.          Caregivers will then have the option to consent to a cohort study, in which data are no          longer anonymous but instead linked to participants' names and contact information.      PROCEDURES. This cohort study piggybacks on procedures already approved for the Let's Get     Healthy! program (OHSU IRB #3694). Let's Get Healthy! is a study in which participants     provide anonymous data at health fairs through any or all of the following manners: short     computer surveys on cancer awareness, risk factors, and family history (with immediate     feedback given on cancer risk and prevention); short computer surveys on diet and sleep     patterns (with immediate printed feedback given); health screening measurements (blood     pressure, height, weight, waist circumference, body mass index, body fat percentage); a     finger stick to assess sugar and fat levels in blood; and a mouthwash swish to provide a     saliva specimen.      However, this cohort study (OHSU IRB #7542) will make the following changes and additions:        -  Personal health data, instead of being anonymous, will be linked to participants' names          and contact information (for follow-up data collection).        -  Let's Get Healthy! events will include cognitive performance tests, a preventative-care          survey, and a work schedule survey.        -  Participants will provide data not only at an initial Let's Get Healthy! event, but also          at a follow-up event and during the time period between events. Between events,          participants will do the surveys on work schedule, diet, and sleep, and they will          complete cognitive performance tests.        -  There will be a separate consent process for participants to provide a fully          identifiable saliva specimen.      DATA ANALYSIS. Participants' health data will be fully identifiable at the time of data     collection but will be coded and stored in a physically separate location from the     identifiable information. The link between identifiable information and coded health     information will be stored on a password protected computer, and all identifiable information     will be deleted upon completion of data analyses. Data will be analyzed to explore     relationships among work schedule, sleep, diet, body composition, metabolic health, chronic     disease, and cognitive performance in caregivers. Genetic relationships with these factors     will be analyzed in those who provided a saliva specimen during entry visit data collection.   "
140678|NCT01443143|"     This investigation will examine the effects of consuming a structured, portion-controlled,     low-glycemic index diet (commercially available as the Nutrisystem-D program) on several     indicators of glycemic stability and variability among participants with type 2 diabetes.     Results on the portion-controlled diet will be compared with those on participants' usual     diets in a randomized cross-over trial. The investigators expect that participants will     exhibit greater glycemic stability (e.g., more time in euglycemic range) and less glycemic     variability (e.g., smaller mean amplitude of glycemic excursions) while consuming the     Nutrisystem D program, as compared with their usual diet.   "
140724|NCT01442545|"     The purpose of this study is to evaluate the effects of JNJ-39758979 on the pharmacokinetics     (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.   "
140679|NCT01443130|"     The purpose of this study is to test prevention strategies for pregnancy-related malaria.     Researchers will compare different malaria treatments and treatment schedules which include     chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each     time) to the standard practice of preventive treatment intervals in pregnancy (with the drug     sulfadoxine-pyrimethamine given twice during pregnancy). Participants will include 900     pregnant women, who will be assigned to one of three treatment groups. Blood samples will be     collected at every visit before birth and any time the participant is ill to determine if     malaria is present. Pregnant women will be monitored during pregnancy and newborns will be     assessed at birth and followed until about 14 weeks. Participant involvement in the study is     expected to last about 12 months.   "
140680|NCT01443117|"     HIV-infected people and pregnant women are at risk of developing severe pneumococcal disease.     The purpose of this study is to compare the safety and immune response to two pneumococcal     vaccines in HIV-infected pregnant women.   "
140692|NCT01442961|"     The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is     faster than after abdominal approach. The aim of this study is to evaluate postoperative pain     after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid     consumption.   "
141135|NCT01437176|"     The purpose of this study is to determine whether this new intramedullary fixation is     effective in the treatment of intertrochanteric fracture.   "
140681|NCT01443104|"     Coronary artery stents have improved the safety and efficacy of percutaneous coronary     intervention for coronary artery disease. Drug-eluting stents have been shown to decrease     neointimal hyperplasia and to reduce the rate of restenosis and target-lesion     revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic     platform and a therapeutic substance that is usually released from a polymer matrix. A     previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and     efficacy profile in a large-scale clinical trial as compared to a first-generation     druf-eluting stent (LEADERS trial).      The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent     with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a     prospective multicenter randomized controlled non-inferiority trial in patients undergoing     percutaneous coronary intervention in routine clinical practice.   "
140682|NCT01443091|"     Colostrum, mothers' early breastmilk, contains multiple factors that provide immune     protection to very low birth weight (VLBW) infants, a population at high risk for     hospital-acquired infections. However, critical illness during the first few days of life     often prevents the initiation of enteral feeds, placing these infants at even higher risk for     morbidities including feeding intolerance and infection. Oropharyngeal administration has     been proposed as an alternative route of delivery for colostrum and the immune benefits it     provides. Research from animal and adult human models supports oropharyngeal administration     as a potentially safe and effective mode of delivery for immune therapies. Immune components     of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune     system. The purpose of this proposed randomized, placebo-controlled pilot study is to     determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in     VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA     response to OAC the investigators will also collect clinical data to determine if OAC has     effects on tolerance of enteral feedings and rates of infection. The investigators     hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW     infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching     consequences for these highly fragile babies including lower rates of infection, improved     tolerance of enteral feedings, and shorter NICU stays.   "
140683|NCT01443078|"     The purpose of this study is to test a new approach to the use of standard drugs before     surgery in patients with lung cancer. This study will find out what effects, good and/or bad,     that this approach has on the cancer.      It is routine to give chemotherapy prior to surgery in patients with this type of lung     cancer, to help keep it from coming back. It is also routine to perform a special type of     scan called a PET scan. This PET scan measures how active a cancer is by use of a special     tracer made out of sugar. In this study, all patients will have a PET scan and then be     treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a     non-squamous cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In     rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most     patients, a repeat PET scan will show that the tumor is decreasing and they will complete     standard chemotherapy then go on to have surgery.      In some patients, a repeat PET scan will show that the tumor has not decreased enough. For     these patients, the routine practice is to proceed with surgery. This research study will     test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine     and cisplatin to a different treatment called vinorelbine and docetaxel is safe and     effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a     different way than pemetrexed or gemcitabine and cisplatin.   "
140684|NCT01443065|"     This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France.     Main eligibility criteria include: histologically proven adenocarcinoma of the stomach,     esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable     disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy.   "
140685|NCT01443052|"     A large proportion of falls in older people occurs when walking. Most studies have recently     demonstrated correlation between the variations in spatiotemporal gait parameters and fall     risk in elderly and in several diseases. The investigators objective is to analyse this     parameters in population with gait stability disorders (post-stroke patients and fallers) to     identify the most valuable and to develop/test a conglomerate stability score.   "
140686|NCT01443039|"     The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric     Bypass.      Primary aim : To study the intra individual evolution of phenotypical markers of different     drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and     P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.   "
140687|NCT01443026|"     The purpose of this research study is to compare the effects of a lycopene supplement made     from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal     cells in the prostate, but have not yet had cancer detected. This study will allow us to see     if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and     in chemicals measured in the blood that go along with a higher risk of developing cancer.   "
140772|NCT01441908|"     The primary objective of this study is to determine any changes in cardiovascular risk among     individuals receiving a statin by assessing their multi-analyte profile.   "
140691|NCT01442974|"     Targeting tumor stroma is emerging as a strategic approach for pancreatic cancer treatment.     Actually, one of the most interesting characteristics of pancreatic cancer is the dense     fibrotic stroma surrounding tumor cells. Moreover, pancreatic cancer stroma seems to express     a specific protein profile different from tumor cells. For example, secreted protein rich in     cysteine (SPARC) is overexpressed in pancreatic tumor stroma fibroblast and downregulated in     tumor cells. This characteristic is associated with poor clinical outcome.      Nab-paclitaxel, an albumin bound nano formulation of paclitaxel that targets SPARC, decreases     tumor stroma density. Such effect improves drug delivery, and enhances both, nab-paclitaxel     and gemcitabine, antitumor activity in nude mouse models.      Based on this pre-clinical data the investigators designed a clinical trial of nab-paclitaxel     in combination with gemcitabine as neo-adjuvant treatment for pancreatic cancer patients.     Fifteen, SPARC positive patients, will be enrolled in the study and treated with abraxane in     combination with gemcitabine.      This is a pilot study which primary end point is evaluating the effect of Abraxane in     combination with gemcitabine on tumor stroma, and the secondary end-point is correlating     these changing with treatment activity.   "
140693|NCT01442948|"     Monocytes may be separated into phenotypically and functionally distinct cell types by the     presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The     investigators hypothesize that the total numbers of CD16+ monocytes are significantly related     to cardiovascular outcome in patients with angiographically proven coronary heart disease.   "
140694|NCT01442935|"     The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the     experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi     chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according     to K-Ras status of the patient's tumor.      The secondary objectives are to evaluate the objective response rate (CR and PR) after 4     cycles of treatment, according the RECIST V1.1 evaluation scale.        -  the rate of complete remission (CR) at 6 months after the last study treatment (hepatic          surgery or last chemotherapy cycle).        -  the specific rates of resection R0, R1, R2.        -  the complete pathological response Rate,        -  the relapse-free survival rate in (R0 or R1) resected patients,        -  the response duration in non-resected patients,        -  the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be          evaluated with the Levi scale,        -  the post operative complications using the DINDO classification,        -  the progression-free survival (PFS) and overall survival (OS).      The objectives of the biological study are:        -  to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF,          TP53) and genetic amplification related factors (EGFR),        -  to evaluate patient-related predictive factors in connection with genetic polymorphisms          (Fc gamma and VEGF receptors),        -  to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free          and progression-free survival,        -  to study circulating of tumor cells as prognostic factor for metastatic colorectal          cancer, non- resectable at presentation.   "
140695|NCT01442922|"     The primary purpose of the study is to establish the degree and duration of pain relief     following minimally invasive surgery for a painful degenerative disc.   "
140696|NCT01442909|"     Both pemetrexed and docetaxel have been reported to have similar activity against non-small     cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III     study. However, no study showed different toxicity and efficacy profiles within individual     patients. Present phase II randomized clinical trial is designed to answer these questions,     with addition of information about whether or not sequential therapy can prolong disease-free     and overall survival.   "
140697|NCT01442896|"     The purpose of this study is to perform exploratory analyses to evaluate rates of functional     and structural change in glaucoma, to identify predictors of rapid progression in patients     with glaucoma and to identify possible genetic factors and biomarkers associated with the     disease.   "
140698|NCT01442883|"     In patients with treatment resistent hypertension renal nerve ablation emerged as an     effective interventional approach of treating hypertensive disease with a progressively     increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is     one of the major underlying pathogenetic mechanism of the fall in blood pressure but the     precise mechanisms that causes the fall in blood pressure in the short-term and, in     particular, long-term remains elusive. The objective of the study is to understand the     pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic     nervous system. In 100 hypertensive patients most advanced technology will be applied, before     and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic     activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling     technique), local activity of the renin angiotensin system in the kidney (urinary     angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI     technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large     arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24     hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall     in blood pressure after renal denervation may help to identify those hypertensive patients     that profit most from renal nerve ablation in terms of blood pressure reduction.      The investigators propose the following hypotheses why a progressive decrease in blood     pressure happens, in addition to the decreased activity of the central nervous system, after     renal nerve ablation:      Short term effects:      A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the     kidney C)Exaggerated sodium excretion immediately after renal nerve ablation      Long term effects:      D)Decrease of total sodium content after 6 and 12 months. E)Improvement of vascular wall     properties after 6 and 12 months   "
140699|NCT01442870|"     Metformin is a drug that is normally used to treat people with diabetes. New research has     discovered that metformin may also kill cancer stem cells. These cancer stem cells make up     only a small portion of a cancer, but may be responsible for resistance to chemotherapy or     for causing recurrence of the cancer. Future studies are envisioned to that test the efficacy     of administering metformin with chemotherapy. The purpose of this study is to assess the     safety of administering metformin in combination with chemotherapy. Since chemotherapy and     cancer itself both cause adverse events by themselves, this study is designed to have a     run-in stage as well as a subsequent randomization to metformin or no metformin. The primary     endpoint will compare the rate of dose-limiting toxicities between these two arms. After a     period of 3 weeks for the primary endpoint comparison, all patients will receive metformin.   "
140773|NCT01441895|"     The study objective is to assess changes in corneal sensation and dry eye signs and symptoms     following cataract extraction/femtosecond arcuate relaxing incisions.      Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond     arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or     worsening of dry eye signs and symptoms.   "
140700|NCT01442857|"     The axillary region is regularly used for brachial plexus block. The technique may be guided     by nerve stimulation, ultrasound or a combination of nerve stimulation and ultrasound.     Magnetic resonance imaging (MRI) has been beneficial in presenting anatomy of interest for     regional anesthesia and in demonstrating spread of local anesthetic (LA). An axillary     MRI-study at our department supported the suggestion of multiple rather than a single     injection technique. Using a 0.5 Tesla open MR scanner in that study, the investigators were     not able to distinguish terminal nerves from equally sized vessels. Therefore the     investigators could not definitely answer whether the LA reached the pertinent nerves. The     investigators have recently performed an axillary block study with a 3.0 Tesla scanner. Now     the terminal nerves were identified and for each patient the investigators could observe if     the LA reached the nerves.      The aim of this study was to demonstrate the anatomy of the brachial plexus in the axillary     region at different levels. The investigators present the best pictures of the nerves with     and without LA injected. The images are demonstrated in the axial and coronal plane.   "
140750|NCT01442194|"     The purpose of this world-wide prospective parallel-cohort study in patients with relapsing     forms of MS, either newly treated with fingolimod or receiving another disease-modifying     therapy, is to further explore the incidence of selected safety- related outcomes and to     further monitor the overall safety profile of fingolimod under conditions of routine medical     practice.   "
140701|NCT01442844|"     This study evaluates a novel micrografting technique to see how it will influence the healing     rate and cosmetic result of second intention wounds. The graft harvesting and micrografting     process was designed by MoMelan Technologies The Epidermal Expansion System, which is     composed of a commercially available Blister Generation Device and the Microblister     Generation and Excision Device (MBGED), will generate an array of small microblisters and     transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing)     for application to the subject's surgical area. The investigators predict that applying     expanded micrografts to wounds that otherwise would have healed by second intention alone     will hasten healing and possible reduce scarring.   "
140702|NCT01442831|"     The purpose of this study is to describe the single dose pharmacokinetics of total     radioactivity in plasma and whole blood following PO administration of [14C] TR-701 in     healthy adult male subjects.   "
140703|NCT01442818|"     The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain     relief and patient satisfaction when compared to scheduled intravenous analgesia following     vaginal reconstructive surgery.   "
140704|NCT01442805|"     The project aims to explore the potential of Virtual Reality Exposure Therapy (VRET) for the     treatment of the fear of driving, the fear of flying and the fear of public speaking.      The study is a randomized controlled trial (RCT) designed to compare the efficiency of     cognitive behavioural therapy with exposures in imagination to behavioural therapy with     exposures in virtual reality. Anxiety levels are measured using specific questionnaires, SUD     ratings and physiological measures (heart rate, skin conductance, skin temperature, breathing     frequency, heart rate variability).      Hypothesis: Treatments with exposures in virtual reality are more efficient than treatments     with exposures in imagination.   "
140705|NCT01442792|"     Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat     patients with obstructive coronary artery disease (CAD). Although PCI is highly effective for     the management of CAD, it can potentiate an existing prothrombotic state around lesion areas.     A certain level of anticoagulation is required to perform planned PCI safely and to minimize     the periprocedural risk of thrombosis and its attendant complications, including myocardial     ischemia and infarction (heart attack). Many different anti-thrombotic regimens have been     investigated and are currently in use. The aim of this study is to explore whether     Rivaroxaban, as compared to unfractionated heparin, on the background of standard dual     antiplatelet therapy, can effectively suppress thrombosis and related adverse ischemic     events, upon balloon inflation and stent expansion, during elective PCI, without increasing     bleeding. The treatment assignment will be done in a semi-blinded design, eg, no blinding for     randomization either to Rivaroxaban (one of the three arms) or the control (UFH) group.     However, all will be blinded for the treatment dose of rivaroxaban (either 10mg or 20 mg).The     10 mg rivaroxaban plus 50 IU UFH arm will not be blinded.   "
140706|NCT01442779|"     The purpose of this study is to determine the possible efficacy of low dose, orally     administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).   "
140707|NCT01442766|"     Stroke is a major personal and social burden, being the commonest cause of severe adult     disability. Recovery has been shown in animal models to be dependent upon adequate levels of     acetylcholine within the brain - which in stroke is likely to be deficient. This is because     acetylcholine-producing nerve cells in the brain are often damaged by strokes. Consequently,     the investigators hypothesise that recovery may be improved by boosting acetylcholine levels     in the brain - that can be readily achieved by treating with donepezil.      AIMS: To establish: 1) whether motor deficits in acute stroke improve more in patients taking     donepezil, relative to placebo, for 12 weeks; 2) whether brain functional MRI changes as a     result of donepezil after 12 weeks.   "
140708|NCT01442753|"     The goal of this project is to evaluate the effectiveness of a family-based tobacco use     prevention intervention directed at immigrant Latino parents of middle school aged youth as     delivered in partnership with seven community organizations. The primary outcomes of the     study are youth susceptibility to tobacco use, and changes in parenting practices among the     parents of the youth. The planning, initiation, and delivery of the intervention will occur     in collaboration with community organizations that have identified this project as important     to the families they serve. Though the collaboratively designed training curriculum has been     successfully tested and a study design for the current project established, a substantive     development period for this project will allow the research team and collaborating     organizations to consider key aspects of design and delivery.   "
140709|NCT01442740|"     Functional Endoscopic Sinus Surgery (FESS) is normally performed in our centre in a 0-degree     supine position, with the patient laying flat. This study will be investigating whether     changing patients to a 15-degree head up, feet down position will improve field of view and     reduce blood loss during surgery. The 15-degree head up, feet down position has been used in     other circumstances, such as brain surgery and for severely obese patients where airways can     be blocked due to lying flat. Every 15 minutes, blood pressure, heart rate and field of view     according to the Boezaart nasal scope scaling system will be recorded.   "
140774|NCT01441882|"     This phase II trial studies how well dasatinib works in treating patients with chronic     lymphocytic leukemia (CLL). Dasatinib may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.   "
140710|NCT01442727|"     Context: Approximately 100 million people throughout the world consume water contaminated     with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh     alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected     regions. There are no proven therapies for treating chronic arsenic toxicity or for     preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a     variety of animal models. The investigators have recently shown in animals and humans that     this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl)     arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two     Phase II studies in China and Bangladesh have suggested clinical benefit to selenium     supplementation in arsenicosis patients.      Objective: To assess whether daily selenium supplementation counters arsenic toxicity in     patients exposed to drinking water arsenic. If proven effective, selenium supplementation     might be safely and cost-effectively implemented in the worst-affected localities.   "
140711|NCT01442714|"     Primary Objective:      - Determine the lack of disease progression (CR/CRi/PR/HI rate) after 6 cycles of treatment     with the combination of azacitidine plus lenalidomide in previously treated patients with     Acute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndromes (HR-MDS).      Secondary Objective:      - Determine the 42-day survival after treatment with this combination in elderly patients     with previously treated AML/HR-MDS patients   "
140712|NCT01442701|"     The investigators intend to investigate whether the rise in childhood obesity is caused by     the loss of recurrent and chronic infections in modern, industrialized society, beginning in     utero and extending through early childhood. The investigators will also examine whether the     antimicrobial triclosan, present in numerous cleaning and hygiene products, decreases the     incidence of infection within a household.   "
140713|NCT01442688|"     This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin     administered alone & in combination with MMX Mesalazine/mesalamine.   "
140714|NCT01442675|"     The purpose of this trial is to describe the safety and antibody response to revaccination     with Menactra vaccine in persons who received their first dose at ≥11 years of age.      Primary Objective:      - To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured     by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in     subjects who were first vaccinated with Menactra 4-6 years ago.      Secondary Objective:      - To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens     collected 6 days post-vaccination in a subset of study population.      Observational Objective:      - To describe the rates of immediate reactions, solicited injection-site and systemic     reactions, unsolicited adverse events and serious adverse events following vaccination.   "
140715|NCT01442662|"     The aim of this research is to study the activity of pazopanib in second line after     anthracyclines in extra uterus and uterine LMS in association with gemcitabine.   "
140716|NCT01442649|"     The main objective is to evaluate progression-free survival (PFS) at 4 months.      The secondary objectives are to evaluate the objective response rate (OR) (= complete     responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the     progression-free survival (PFS), the overall survival (OS), the overall survival from the     date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance     (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the     quality of life according to the EORTC QLQ-C30 criteria.      The objectives of the biological study are to evaluate potentially predictive anti-EGFR and     anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of     bevacizumab associated with chemotherapy in mCRC treatment.   "
140717|NCT01442636|"     The objective of this clinical evaluation is to evaluate the immediate and long term (up to     12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott     Vascular) in a controlled prospective investigation for the treatment of patients with     critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the     level of the below the knee arteries. Specifically the trial aims to illicit angiographic and     ultrasound patency, clinical improvement, and adverse events associated with the use of this     stent. The trial design is single armed, prospective, controlled trial run over 12 months of     follow-up.   "
140718|NCT01442623|"     Dizziness is a common and disabling symptom and is associated with unsteadiness in both     standing and walking, sometimes resulting in falls. People who have any of these problems     often have a disease process affecting the inner ear. A proportion of people will recover     spontaneously over time; those that do not may benefit from a specialized form of     physiotherapy known as vestibular rehabilitation. This consists of exercise regimes that are     individualized to each person depending on their problems. These regimes aim to decrease     dizziness, help patients to re-learn movement patterns and improve their balance during     standing and walking. There is considerable research supporting vestibular rehabilitation but     it is not clear what is the best type, setting or frequency of treatment. How therapy impacts     on walking ability is also not clear. Recent developments have suggested that force plate and     virtual reality therapies may benefit. This form of therapy can provide feedback that is     unavailable with conventional exercises. Exposure to virtual environments can challenge     balance which helps to retrain it. The aim of this study is to compare conventional     vestibular rehabilitation with a force plate/virtual reality therapy based vestibular     rehabilitation, using a universally available virtual reality system (Nintendo Wii Fit     Plus®). In this study, consenting patients with a vestibular disorder will be assigned     randomly to either a conventional treatment or a virtual reality based treatment that is     customized to their individual problems. They will receive treatment for 8 weeks. The effects     of treatment will be measured by state of the art computerized analysis of walking and     balance. Questionnaires that obtain information about how severe their dizziness is will also     be administered. The study will help therapists understand how inner ear problems affect     walking and balance. It will also provide information on the optimum method of providing     vestibular rehabilitation and thus improve patient care.   "
140719|NCT01442610|"     As the MAO-B inhibitor rasagiline is able to improve motor skills it might have positive     effects on sleep disruption by reducing nocturnal akinesia. As it was reported to cause only     minor sleep disruption in PD Patients, it might be able to improve sleep architecture. The     investigators thus study the effects of Rasagiline on sleep disturbances measured by     polysomnographic (PSG) evaluation of sleep efficacy and PDSS-2. Secondary measures are other     sleep variables measured by PSG, sleep quality and daytime sleepiness assessed by     standardized scales as well as cognitive function, depression and QoL index.   "
140720|NCT01442597|"     The investigators are conducting a randomized clinical trial of our new web-based version of     the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling     at SATU. The computer-based training program (CBT4CBT) focuses on teaching basic coping     skills, presenting examples of effective use of coping skills in a number of realistic     situations in video form, and providing opportunities for patients to practice and review new     skills while receiving substance abuse treatment.   "
140725|NCT01442532|"     The purpose of Part 1 of this study is to evaluate the safety, tolerability, and     pharmacokinetics (PK, how the drug is absorbed in the body, distributed within the body,     and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo     following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian     adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on the     pharmacokinetics of midazolam in healthy participants.   "
140746|NCT01442246|"     PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to     10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24     months after radical prostatectomy in patients with high risk of recurrence.      SECONDARY OBJECTIVE(S):        -  PSA evolution        -  Evaluation of testosterone level        -  Specific survival        -  Overall survival        -  Tolerance        -  Quality of life (QLQ-C30 questionnaires)   "
140726|NCT01442519|"     Intravesical treatment for superficial bladder cancer has been used for the past 4-5 decades.     Intravesical chemotherapy is beneficial in terms of recurrence and time to recurrence in     grade 1-2 stage Ta tumours, usually non-invasive. Intravesical chemotherapy has negligible     effect on disease progression in high-risk superficial bladder cancer—ie, grade 3, stage T1,     and carcinoma in situ. However, BCG as induction and maintenance treatment effectively delays     progression. Electromotive mitomycin increases tissue uptake compared with that of passive     diffusion. Electromotive mitomycin has emerged as an alternative or complementary treatment     to BCG. The rationale for combining anticancer drugs is based on the need to increase     efficacy and reduce emergence of resistant malignant cells. This approach is not frequently     applied to use of intravesical agents for treatment of superficial bladder cancer, for which     immunotherapeutic BCG and chemotherapeutic mitomycin seem to be a potentially effective     combination. Studies have addressed concurrent use of mitomycin and BCG, and assigned two     roles to mitomycin: antitumor action and tissue-scarifying (ie, surface-modifying) effect     that enables BCG to attach more efficiently to the urothelium. The investigators therefore     aimed to assess whether induction of inflammation by use of BCG before mitomycin treatment     makes the bladder mucosa more permeable and thus enables mitomycin to reach the target more     easily. This randomised trial to compare the efficacy of sequential BCG and electromotive     mitomycin with that of the current standard of BCG alone for patients with high-risk     superficial bladder cancer.      After transurethral resection and multiple biopsies patients with stage pT1 bladder cancer     are randomly assigned to: 81 mg BCG infused over 120 min once a week for 6 weeks; or to 81 mg     BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive mitomycin     (intravesical electric current 20 mA for 30 min) once a week as one cycle for three cycles     (n=107). Complete responders underwent maintenance treatment: those assigned BCG alone had     one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG and mitomycin     had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg BCG once a     month as one cycle for three cycles. The primary endpoint was disease-free interval;     secondary endpoints were time to progression; overall survival; and disease-specific     survival. Analyses were intention to treat.   "
140727|NCT01442506|"     Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus.     Chromoendoscopy after local acetic acid application enables recognition of the mucosal     surface architecture. The new available EPKi processor (Pentax, Japan) enables HD+ resolution     above HDTV standard. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction     with i-Scan or acetic acid to diagnose Barrett`s esophagus. The primary endpoint of the     current prospective study is to investigate the diagnostic yield of virtual chromoendoscopy     using the i scan function as compared to acetic acid chromoendoscopy and 4-quadrant biopsies.      Patients with visible columnar lined lower esophagus (CLE) are included. After standardized     PPI therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo     either chromoendoscopy in conjunction with acetic acid application or i-Scan. Biopsies are     taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies     are taken.   "
140728|NCT01442493|"     The purpose of the study is to determine whether a change in the rules and staff roles in     methadone treatment programs will result in greater lengths of stay in treatment and lower     rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone     treatment as usual.   "
140729|NCT01442480|"     Exposure to ambient levels of air pollution increases cardiovascular morbidity and mortality.     Advanced age is among the factors associated with susceptibility to the adverse effects of     air pollution. Dietary fatty acid supplementation has been shown to decrease cardiovascular     risk through multiple mechanisms. This study evaluated the efficacy of supplementation with     marine fish oil or olive oil in protecting against cardiovascular effects induced by     controlled exposure of middle-aged healthy volunteers to concentrated ambient air pollution     particles. Subjects (ages 50 to72 years), were randomly assigned to receive 3 g/d of fish oil     (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid), or olive oil (3g/d) for 28 d.     Subjects were then exposed to concentrated ambient air pollution particles or filtered air     for 2 hr on sequential days. Heart rate variability (HRV), plasma lipids, coagulation     markers, and endothelial function measured by flow-mediated dilation of the brachial artery     (FMD) were assessed pre-, immediately post-, and 20 hr post-exposure.   "
140730|NCT01442467|"     This study aims to evaluate the accuracy of the echocardiographic data obtained from patients     with calcifications in the mitral valve who are undergoing a cardiac (heart) catheterization.      Echocardiography is a non-invasive (does not break the skin) procedure used to see an image     of the heart. It uses harmless sound waves to create an image of the heart on a computer     screen. These images will show the valves of the heart, how well the heart is pumping blood,     the blood flow across these valves and how large the heart is. A silver paddle-shaped device     is moved easily over the skin to capture these images.      Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding the     valves) is a common finding and it increases with age. The presence of calcification changes     the blood flow through the heart valves. This makes any echocardiographic data (information)     obtained from patients with calcifications difficult to interpret.   "
140731|NCT01442454|"     The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic     pancreatitis with surgical pathology.   "
140732|NCT01442441|"     In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS)     criteria for diagnosing chronic pancreatitis can be correlated with pathologic     characteristics of tissues taken from pancreas of patients with suspected chronic     pancreatitis.      This will be a retrospective study which will examine results from biopsy specimens and     endoscopic ultrasound findings in suspected chronic pancreatitis.   "
140733|NCT01442428|"     Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons     worldwide, including in South East Asia. Significant numbers of patients experience     tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after     ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent     randomized-controlled trial showed the benefit of prednisone over placebo in reduction of     days of hospitalization and invasive procedures. The investigators hypothesize that     nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for     treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that     adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase     inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a     2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for     the symptomatic and immunologic control of TB-IRIS.   "
140775|NCT01441869|"     Study in healthy subjects to measure amount of drug in blood after dosing with different     saxagliptin / metformin products.   "
140747|NCT01442233|"     In more than 40 % of multiple sclerosis (MS) patients experiencing relapse, residual     disability accumulates in spite of steroid treatment. Plasma exchanges are frequently used     but there is no established evidence of their efficacy.   "
140748|NCT01442220|"     Pituitary adenomas is a very common disease, but the cause and genetics hasn't been     identified. The investigators are going to use genome-wide association study to identify     genes that may be related to pituitary adenomas.   "
140734|NCT01442415|"     Childhood cancer survivors (CCS) are prone to develop obesity and are at increased risk of     developing cardiovascular disease and type 2 diabetes compared to the general pediatric     population. Few lifestyle modification trials have been conducted in overweight/obese CCS and     it is unclear whether CCS respond similarly to lifestyle modification compared to     overweight/obese individuals who have not had cancer (non-CCS). We propose a 3-year pilot     study that will enroll separate cohorts of overweight/obese CCS and overweight/obese non-CCS     every September into a family-based lifestyle modification program consisting of weekly     sessions at the University of Minnesota. The goal of the program will be to facilitate     improved physical fitness, weight management, heart health, and quality of life.   "
140735|NCT01442402|"     Aim 1:      Determine if there is an association between the APOL1 risk variants and allograft survival     and function in African Americans      Aim 2:      Determine if there is an association between the presence of APOL1 risk variants in an     African American kidney transplant recipient and the risk of recurrent disease      Aim 3:      Investigate mechanisms of APOL1 associated kidney disease by prospectively following African     American kidney transplant recipients throughout their clinical course.   "
140736|NCT01442376|"     The primary objective is to evaluate the efficacy of two different doses of IV palonosetron     in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through     120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The     secondary objectives are to evaluate the safety and tolerability of IV palonosetron in     pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of     pediatric CINV patients.   "
140737|NCT01442363|"     This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is     designed to determine the effects of BLI-1300 ointment on perianal pain associated with     active Perianal Crohn's Disease (PCD).   "
140738|NCT01442350|"     The cardiac variant of the Fabry disease is a rare cardiomyopathy affecting 1/50000     individuals in general population. It is generally diagnosed in advanced stages of the     disease, because it presents clinical features very similar to the hypertrophic     cardiomyopathy ones, making difficult the correct diagnosis. In Fabry disease there is a     remodeling process of the myocardial interstitium and apoptosis of myocytes which leads to     fibrosis development and later systolic dysfunction. The investigators propose to evaluate     the utility of several biomarkers in the diagnosis of this cardiomyopathy, to facilitate the     early diagnosis, which is clue to establish early enzyme replacement therapy or intensify the     patients' follow up. In order to achieve this objective, the investigators will analyze     markers of endothelial dysfunction, fibrosis and apoptosis in peripheral blood samples of     patients carrying the mutation but without clinical manifestations and the investigators will     compare their levels with dose obtained from two different control groups: diagnosed patients     presenting clinical manifestations or index cases and healthy controls without carrying the     mutation.   "
140739|NCT01442337|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of a single     intravenous dose of ASP8597 in kidney transplant recipients.   "
140740|NCT01442324|"     Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation     (IRE) as the sole treatment of nodules not considered treatable by resection or thermal     ablation.   "
140741|NCT01442311|"     Drug users account for a disproportionately large burden of hepatitis C virus (HCV)     infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients     who use drugs regularly during HCV treatment. Because HCV treatment is most effective when     patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve     HCV treatment adherence need to be developed and evaluated. The investigators designed the     HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy     provided on-site at a methadone clinic. The primary objective of this trial is to determine     whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is     more efficacious than standard DOT with weekly provider-administered pegylated interferon     (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV     treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with     increased adherence and rates of sustained viral response compared with PEG-DOT.   "
140742|NCT01442298|"     The use of bloodless field is a helpful and important method in orthopedic surgery. The     surgery can be done without interrupting bleedings, while keeping an exact overlook of the     anatomy. However the method is not without risks, and complications of various kind may     occur. One of the most important factors to minimise the risk of complications, is to keep     the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated     neuromuscular abnormalities after bloodless field among many patients which may lead to a     prolonged rehabilitation period since they cause a postoperative weakness in the muscles.     Although in these studies an unnecessary high tourniquet pressures were used and the EMG     tests were made 6 weeks and 6 months after the surgery.      With today's demand for fast rehabilitation, there is a need for better knowledge if lower     tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.      Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood     flow. It accounts for a patients limb and vessel characteristics and the type and fit of the     tourniquet cuff. The method has developed and is now simplified, by using an automatic     (plethysmographic) sensor placed on the second toe on the involved limb, and after     administration of anaesthesia, and immediately before limb preparation and draping it     measures the limb occlusion pressure.      When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP     pressure measured. The LOP method is still rarely used it has been seen as difficult and time     consuming.      The primary aim of this study is to investigate whether you can reduce the used tourniquet     pressure with the new LOP measurement technique and still have a adequate bloodless field;     and if this will lead to any clinical difference regarding postoperative pain. The secondary     aim is to investigate the difference between the test groups concerning muscle function and     wound healing and if these are remaining and of clinical importance. The third aim is to     study how common neuromuscular abnormalities are after the use of bloodless field with lower     cuff pressures and if there are any differences between the standard method and the LOP     method.   "
140743|NCT01442285|"     The purpose of this study is to understand more about meeting the psychosocial needs of     people who have cancer.   "
140744|NCT01442272|"     The purpose of this study is to determine the value the additional antiproteinuric effects of     vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with     lack of vitamin D and residual proteinuria higher 0,5 grams/day.   "
140745|NCT01442259|"     The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in     subjects with a different degree of renal impairment.   "
140949|NCT01439594|"     The goal of this research is to conduct a pilot clinical study to evaluate the potential use     of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of     injury associated with therapeutic radiofrequency ablation techniques.   "
140752|NCT01442168|"     The purpose of this study is to determine the tolerability and pharmacokinetics of     Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil®     (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated     malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected     erythrocyte sequestration and rosette formation.      The study consists of a dose escalation part (part 1) followed by an open labelled,     randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone     (part 2).   "
140753|NCT01442155|"     This observational study evaluates the efficacy and safety of capecitabine in combination     with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data     were collected from each participant for up to 36 months or until disease recurrence.   "
140754|NCT01442142|"     The objective of this study is to pilot test, evaluate and compare the effects of Cue     Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT)     in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce     eating in the absence of hunger in overweight children immediately following treatment and     6-months post treatment.      The primary aim of this proposed study is to evaluate the efficacy and compare the     effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite     Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight     children. Following this first intervention, a second intervention to determine the efficacy     of a combination program (combined CAAT & CRST) will be implemented.      The secondary aim of this study is to evaluate change in the following related measures for     both children and adults who participated in CRST, CAAT, and the combination program: BMI for     age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk     food situations.   "
140755|NCT01442129|"     The main purpose of this research is to determine whether injecting mesenchymal precursor     cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD)     is safe. MPCs are normally present in human bone marrow, and have been shown to increase the     development of blood vessels and new heart muscle cells in the heart. In addition, this     research is being done to test whether injecting the MPCs into the heart is effective in     improving heart function.   "
140756|NCT01442116|"     The study hypothesis is stress-related regional tissue dynamics is related to left     ventricular outflow tract blood flow.   "
140757|NCT01442103|"     This investigation will be conducted in the US as a single-center study to evaluate in total     10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.   "
140758|NCT01442090|"     Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with     metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be     randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.   "
140759|NCT01442077|"     Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of     new blood vessels. The investigators hypothesized that LISW therapy could improve the     symptoms of patients with erectile dysfunction resulting from a problem of blood supply who     respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.   "
140760|NCT01442064|"     This is an open-label, multicenter, extension study of intravitreally administered     ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g,     NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV)     secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a     Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g     (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema     secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month     observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018)     or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the     previous study.   "
140787|NCT01441713|"     Patients with advanced prostate cancer usually receive some kind of pharmaceutical castration     or undergo surgical castration. At the investigators department the pharmaceutical treatment     is most often given with a 3 month interval.      Over the last few years new drugs, which allow for lees frequent treatment, have been     developed. The purpose of this study is to assess how the treatment affects patients and if     our current patients would prefer to receive treatment at different intervals than they do at     the present time. At the same time the investigators will assess how surgical treatment     affects our patients. This will be assessed by patient questionnaires administered at our     clinic.   "
140761|NCT01442051|"     The purpose of this study is to help us learn how to lower the risk of a blood transfusion     during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique     performed in the operating room before the procedure begins that may reduce the risk of     needing a transfusion during ovarian cancer surgery. During surgery, the patient's own blood     is given back to them when needed, usually due to bleeding. If you don't need blood during     surgery, your own blood will be given back at the end of the case.      The idea behind ANH is that that by removing the blood and replacing it with other fluids,     the remaining blood becomes diluted. This diluted blood is then lost during surgery, usually     due to bleeding. The original non-diluted blood is then transfused back as needed. This may     mean a lower chance of needing an additional blood transfusion.      ANH has been studied at this hospital for other types of cancer. These studies suggest that     ANH may help conserve blood. Although most studies suggest that ANH can be performed safely,     one study showed that ANH could be associated with a higher rate of serious bowel     complications than standard treatment. In this study, patients who underwent ANH had a higher     rate of anastomotic leaks during bowel surgery. An anastomotic leak occurs when two ends of     bowel that have been cut and sewn back together (the anastomosis), fall apart. The     investigators don't know whether ANH will result in higher rates of anastomotic leaks in     patients having ovarian cancer surgery. In fact, in another study evaluating ANH in patients     having the kind of bowel resections that often occur in ovarian cancer surgery (the colon),     no increased risk of anastomotic leaks was observed. For these reasons, researchers at MSKCC     are conducting a study to find out if ANH can be used safely in patients undergoing surgery     for ovarian cancer.   "
140762|NCT01442038|"     This study will evaluate the efficacy of ranolazine as compared with placebo when used as     part of standard medical therapy in chronic angina subjects with incomplete revascularization     post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on     the composite of ischemia-driven revascularization or ischemia-driven hospitalization without     revascularization.   "
140763|NCT01442025|"     To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab)     trough level measurements and adjustment of dosing based upon these levels by means of two     different standardized algorithms in comparison with 'standard of care' IFX treatment and its     effects on clinical and endoscopic outcomes.   "
140765|NCT01441999|"     The treatment of adult deformity has improved with the development and use of modern     segmental instrumentation, including posterior instrumentation. However, the incidence of     proximal junctional kyphosis (PJK) caused by the accelerated degeneration of the joint     capsules and smaller articular processes in the proximal junctional region has also been     noted.      One potential way of decreasing PJK is to decrease the structural rigidity of the construct     at the top thereby providing a transition to the non-instrumented spine and allowing for less     facet capsule and muscle disruption.   "
140766|NCT01441986|"     The purpose of this trial is to demonstrate that dextromethorphan (DXM) and amantadine     compared to placebo exert blood glucose (BG) lowering effects following an oral glucose     tolerance test (OGTT) in male subjects with T2DM.   "
140767|NCT01441973|"     The purpose of this study is to determine whether elotuzumab will improve response in     patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the     health of the body's immune system)   "
140768|NCT01441960|"     Electroconvulsive therapy (ECT) is the transcutaneous application of small electrical stimuli     to the brain to produce generalized seizures for the treatment of selected psychiatric     disorders such as severe depression. The aim of ECT is to induce a therapeutic tonic seizure     where the person loses consciousness and has convulsions. Patients need general anesthesia     and neuromuscular blockade to treat pain and avoid excessive tonic clonic motor contraction     that might be associated with compression fractures. Neuromuscular blocking drugs (NMBD) are,     therefore, administered after induction of general anesthesia to induce neuromuscular     blockade. Despite the importance of NMBDs to provide optimal conditions for ECT treatment,     the optimal NMBD dose to achieve acceptable neuromuscular blockade without excessive or     untoward effects has not previously been identified in any study and in a prospective     randomized fashion. The aim of this study is, therefore, to identify the optimal NMBD dose of     two commonly used neuromuscular blocking agents (succinylcholine and rocuronium) in order to     optimize the muscle strength modulation during ECT that facilitates ECT with the minimal side     effects.   "
140769|NCT01441947|"     The study drug cabozantinib works by inhibiting several different proteins which are believed     to be involved in breast cancer tumor growth, its ability to spread, and its ability to form     new blood vessels. This drug has been used in other research studies and information from     those other research studies suggests that this drug may help to prevent cancer growth.      The single agent portion of this study is now closed to accrual. This research study is now     examining the efficacy of cabozantinib in combination with fulvestrant for treatment of     hormone-receptor-positive breast cancer that has spread to bone.   "
140770|NCT01441934|"     Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary     diseases, and it is an independent prognostic factor, until now no evidence-based treatment     approach exists for those patients.      This study will address if the drug sildenafil can lower pulmonary vascular resistance in     patients with significant pulmonary hypertension (high blood pressure in the lungs)     associated to chronic obstructive pulmonary disease (COPD). It will see if this treatment can     improve effort capacity, quality of life without causing a deterioration in pulmonary gas     exchange (mainly arterial oxygenation).      Patients 18 years of age and older with moderate COPD and pulmonary hypertension (mean     pulmonary arterial pressure >30 mmHg) may be eligible for this study. Participants are     randomly assigned to receive sildenafil or placebo (pill with no drug) for 16 weeks.      Before starting treatment (baseline), and a the end of the study, the patients have a     comprehensive assessment including:        -  a chest x-ray and CT scan (only at baseline);        -  pulmonary function tests to measure how much air the patient can breathe in and out, and          the capacity of diffusion of gases;        -  arterial blood gases analysis (for safety reason this examination is performed at          baseline, before the randomization after one hour from the administration of a tablet          (20 mg) of sildenafil, and every month)        -  an echocardiogram (heart ultrasound) (only at baseline);        -  a 6-minute walk test to measure exercise capacity;        -  a quality-of-life assessment (SF-36 questionnaire)        -  a right heart catheterization to evaluate the severity of hypertension      At the end of the 16-week period, patients may opt to continue to receive sildenafil and     monitoring in an open-label phase of the study for up to 1 year.   "
140771|NCT01441921|"     Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance     status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated     abnormalities.   "
140776|NCT01441856|"     The added value of the laparoscopic hemihepatectomy compared to the open hemihepatectomy has     never been studied in a randomized controlled setting. Therefore, the multicenter     international ORANGE II PLUS - trial has been constructed and will provide evidence on the     merits of laparoscopic versus open hemihepatectomy in terms of time to functional recovery,     hospital length of stay, intraoperative blood loss, operation time, resection margin, time to     adjuvant chemotherapy initiation, readmission percentage, (liver-specific) morbidity, quality     of life, body image, reasons for delay of discharge after functional recovery, long term     incidence of incisional hernias, hospital and societal costs during one year and overall     five-year survival.   "
140777|NCT01441843|"     The purpose of this study is to determine whether lorazepam, which is used to lower     preoperative anxiety, also improves postoperative recovery.      This study data will also be used for further research aiming to identify vulnerable patients     in the day-case surgery setting.   "
140778|NCT01441830|"     The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave     therapy) combined with supervised exercises will improve function and reduce pain in     subacromial shoulder pain compared with supervised exercises alone.   "
140779|NCT01441817|"     The purpose of this study was to determine if internal fixation of the medial malleolus is     necessary following open reduction and internal fixation of the lateral and, if required, the     posterior malleolus treating displaced bi-or trimalleolar ankle fractures.   "
140780|NCT01441804|"     Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response     to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that     there is no important difference in effect between the two treatment effect.   "
141136|NCT01437163|"     The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy     system configured in a novel product called the TopHat 655 system, for promoting hair growth     in males and females diagnosed with androgenetic alopecia of the head.   "
140781|NCT01441791|"     The purpose of this international, multicentre, double-blinded randomized controlled trial is     to determine if the open lung approach providing recruitment maneuvers and PEEP(Positive     End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves     respiratory function in the immediate post-operative period after major abdominal surgery.      Participating centres throughout the world will include a total of 900 adult patients     undergoing general anesthesia for open abdominal surgery with high or intermediate risk for     post-operative pulmonary complications. Patients are randomized and intra-operatively     ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment     maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment     maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge     and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication     (see below). Secondary endpoints are post-operative extra-pulmonary complications,     intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care     Unit) (re-) admission, and length of hospital stay.   "
140782|NCT01441778|"     The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is     superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms     in children with allergic rhinitis.   "
140783|NCT01441765|"     CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug     that are known to target specific cells (in this case, cells in the immune system) The DC RCC     Vaccine is agent that tries to help the immune system to recognize and fight against cancer     cells.      The purpose of this research study is to determine the safety of CT-011 alone, and in     combination with the Dendritic Cell Renal Cell Carcinoma (DC RCC) vaccine. The investigators     are also trying to find out what effect the combination has on the disease, and on your     immune system.   "
140784|NCT01441752|"     The investigators performed a multi-center, randomized, controlled, double-blind, prospective     study on evaluating effect of chemotherapy combined with or without integrated TCM on quality     of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators     plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting     that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with     chemotherapy compared to that by chemotherapy alone.   "
140785|NCT01441739|"     Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and     mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a     diagnostic challenge to clinicians. The initial clinical manifestations of NEC are     non-specific and indistinguishable from other gastrointestinal disorders and sepsis.      The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage.     For the development of new diagnostic markers, the investigators require knowledge of     pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the     second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of     the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.   "
140786|NCT01441726|"     Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other     related dementia are increasingly prevalent in older people. At an advanced stage,     institutionalization in a long-term care (LTC) setting will be the fate of a majority of     patients. A structured palliative care approach is increasingly used for cancer patients, but     is still rarely accessible in LTC institutions for older people with advanced or terminal     dementia. This approach should include a more systematic detection and treatment of pain and     other physical and psychological symptoms during the last weeks of life, as well as better     communications between patients, families and care staff, particularly relating to advanced     care directives. Objectives: The general objective of this study is to implement and evaluate     a multidisciplinary and multidimensional program of palliative and end-of-life care for older     persons with terminal dementia in LTC facilities. Methodology: The intervention program will     include five components:        1. daily involvement of a nurse from the regular staff in the LTC facility as a change          agent;        2. awareness sessions with administrators and staff on the importance of high quality          palliative care in dementia;        3. a training program for physicians and all the staff involved in direct care of patients;        4. systematic discussions with families and distribution to families of a document on          different aspects of palliative care in dementia;        5. systematic clinical care by regular staff for the control of pain, respiratory symptoms          and mouth care. The program will be implemented in two LTC settings (one in Quebec City          and one in Sherbrooke, Quebec, Canada), and results will be compared with the LTC          control settings where usual care will be applied without implementation of the program.   "
140788|NCT01441700|"     Compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of     monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine     position.   "
140789|NCT01441687|"     This randomized pilot phase I trial studies the best way, either expressed prostatic     secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in     patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help     doctors detect prostate cancer. It is not yet known whether EPS or PMU biomarkers are more     effective in predicting prostate biopsy results   "
140790|NCT01441674|"     The primary purpose for this study is to determine if children who receive Occupational     Therapy while they are an inpatient in the hospital will be more motivated to participate in     therapy as well as increase the amount of time they will work during that particular session     when a therapy dog is present during their sessions. The investigators will also be     collecting data regarding a child's heart rate and blood pressure prior to the session     starting and ending to determine if having a therapy dog present also helps relax a child.   "
140791|NCT01441661|"     This non-interventional study includes patients with advanced renal cell carcinoma who are     treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial     is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine     use of Sunitinib.   "
140802|NCT01441518|"     Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with     increased perinatal and maternal complications. The most serious maternal complication is the     risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications     include fetal macrosomia with consequent increased risk of obstetrical trauma and     hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and     metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational     hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For     the tight control of blood glucose, pregnant women are treated as home care (outpatient) or     hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus     hospital care of gestational diabetes and mild gestational hyperglycemia.   "
140792|NCT01441648|"     More than 1 million people worldwide wear soft contact lenses for refractive error     correction. However, severe sight threatening complications due to contact lens wear such as     contact lens-related microbial keratitis (CLMK) are about 1 per 2500 persons per year. The     rate of infection increases drastically to 1 per 500 person per year if lenses were worn     overnight. Recently, color tinted cosmetic soft contact lenses, which are essentially soft     contact lenses with a color tinted annular ring, are gaining increasing popularity especially     among the younger and Asian population desiring a change in iris color or the doll-eyed look.     However, studies on the effect of these lenses on the ocular surface have been scarce.     Recently, a report of 12 cases of lens-related microbial keratitis due to wear of the color     tinted lenses have been reported. Others reported of decreased contrast sensitivity,     increased higher order aberrations, and temporary changes in corneal topography due to color     tinted lens wear. Nevertheless, comprehensive and prospective study has not yet been done.     Thus, the purpose of this study is to conduct a prospective observational study to determine     the influence of color tinted cosmetic contact lens wear both on visual performance and     ocular surface alterations.   "
140793|NCT01441635|"     The purpose of this proof-of-concept study is to determine whether elagolix (ABT-620) is safe     and effective in the treatment of pre-menopausal women, 20 to 49 years of age, with heavy     uterine bleeding associated with uterine fibroids. The effect of elagolix (ABT-620) on     uterine size, fibroid size, and bleeding associated with uterine fibroids will be assessed     versus placebo, and in combination with add-back therapy.   "
140794|NCT01441622|"     Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with     Obstructive Sleep Apnea Syndrome (OSAS).      The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during     attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.   "
140795|NCT01441609|"     An observational study will be performed in subjects aged 3-65 years old to describe the     dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find     out the expression levels of Th9 cells and IL9 in subjects with different response to the     primary immunization (3 single -dose injunctions).   "
140796|NCT01441596|"     The aim of this study is to investigate the efficacy and safety of afatinib alone or in     combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic     breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based     therapy   "
140797|NCT01441583|"     The purpose of the IVORY Study is to gather data to support global submissions/approvals for     some models of the Ingenio device family.   "
140798|NCT01441570|"     In an open label analysis, nebivolol has been shown to have a positive impact on quality of     life in the general hypertensive population. That is, patients treated with nebivolol     reported less side effects compared to those treated with metoprolol. Also, more nebivolol     treated patients reached normalization of blood pressure. Although there is no data, it is     believed that the impact would be similar in renal transplant recipients.      The primary goal of this study is to determine if nebivolol will improve the quality of life     measurements of kidney transplant recipients as compared to those treated with metoprolol     succinate. This will be measured by comparing the scores of four quality of life     questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of     this study are to determine if the use of nebivolol is cost-effective in the renal transplant     recipient; determine if there is a change in urine protein excretion and renal function with     the use of nebivolol; and determine the number of patients that maintain or achieve a target     blood pressure of ≤ 120/80 mmHg.   "
140799|NCT01441557|"     Main objectives:      Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in severe     botulinic poisoning in measuring the effect on electrophysiological and respiratory     parameters      Secondary Objective:      Study the natural history of electrophysiological and respiratory parameters during the     botulinic intoxication      Primary endpoint:      Clinical, electrophysiological and respiratory before and after administration of     3,4-diaminopyridine.      Study Design:      Pilot study, prospective, interventional.      Study population:      Case series (n = 8 patients) suffering from botulinic type A, respiratory failure, but with     no other organ failure      Experimental treatment :      3,4-diaminopyridine, FIRDAPSE ® (BioMarin) The dosage will be gradually increased according     to a predetermined scheme and will not exceed 60 mg / day and 20 mg / dose.      Statistics:      Intra-individual comparison of physiological parameters measured before and after     administration of 3,4-diaminopyridine. Electromyographic and respiratory parameters will be     measured for each patient. Then a dose of 10 mg of 3,4-diaminopyridine will be administrated.     If this dose is well tolerated and provides a relative improvement of 10% for at least one of     the parameters studied, the dose will be maintained at 10 mg for 48 hours 3 times a day then     increased to 20 mg.      The primary endpoint is the change in the amplitude of muscle response evaluated by the     subtraction of amplitude at T1.5 and T0.   "
140854|NCT01440829|"     The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on     plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt     (TIPS) procedure.   "
140855|NCT01440816|"     This phase II trial studies how well giving interleukin-12 gene and in vivo     electroporation-mediated plasmid DNA vaccine therapy works in treating patients with Merkel     cell cancer. Placing the gene for interleukin-12 into Merkel cells may help the body build an     effective defense to kill tumor cells   "
140800|NCT01441544|"     Increasing physical activity continues to be a challenge among many individuals, particularly     those who are overweight. Recent data from the National Health and Nutrition Examination     Survey (NHANES) showed that individuals who reported engaging in a variety of activities were     more likely to meet national physical activity recommendations compared to those who reported     no variety. Incorporating a variety of activities into a physical activity program may be a     way to increase physical increase physical activity levels.      One method to increase variety in physical activities is to use active videogames. Videogames     that use motion sensors allow a gamer to physically perform a variety of activities. Thus,     the purpose ot this laboratory-based investigation is to conduct a study to examine the     effect of engaging in a greater variety of active videogames on energy expenditure in 30     non-obese, regularly active adults.   "
140803|NCT01441505|"     Recently, interest has emerged in the use of ketamine as an antidepressant. Recent     placebo-controlled clinical trials administering a single dose and an open label trial giving     repeated doses shown that ketamine is markedly superior to placebo at reducing depression,     including in treatment-resistant patients, and that its antidepressant effects have a very     rapid onset.      This clinical study consists of two phases. In Phase I, participants who satisfy inclusion     criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or     0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II,     they will receive repeated sessions of ketamine at variable doses over three weeks. During     both phases, mood, psychiatric, and neuropsychological outcomes will be measured.   "
140804|NCT01441492|"     This randomized prospective trial is designed to test the hypothesis that pancreatectomy     without routine intraperitoneal drainage does not increase the severity or frequency of     complications within 60 days of surgery.   "
140805|NCT01441479|"     The purpose of this study is to demonstrate the ability of the Strep A Fluorescent     Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence     of Strep A when compared to culture.   "
140806|NCT01441466|"     The purpose of this study is to investigate the effect of cohort isolation of RS(respiratory     syncytial virus)-positive bronchiolitis versus RS-negative bronchiolitis on prevention of     co-infection and clinical disease severity. Furthermore the investigators want to elucidate     general epidemiological data on bronchiolitis concerning viral causes and the associated     clinical severity.      The investigators want to conduct a prospective cohort study, comparing incidence of     co-infection and clinical severity, in two cohort: one with isolation of RS positive     bronchiolitis as a separate cohort within bronchiolitis and one without isolation (all     children with RS-negative bronchiolitis are nursed together independent of viral agent)   "
140807|NCT01441453|"     The purpose of this study is to determine whether liver transient elastography performed     before the surgical procedure is able to predict liver failure in patients undergoing     hepatectomy for hepatocellular carcinoma.   "
140808|NCT01441440|"     This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group     study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and     venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study     consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The     follow-up visit will be evaluated after 2 weeks of last study medication dosing.   "
140809|NCT01441427|"     With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors     ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and     necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating     Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human     developmental biology. Among these roles, they have trophic actions on villous height and     bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of     enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding     intolerance and /or NEC in preterm infants.   "
140810|NCT01441414|"     To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736)     in patients that have received one prior systemic regimen for metastatic renal cell carcinoma     (mRCC) vs. axitinib alone.   "
140811|NCT01441401|"     This investigation aims to understand the following issues in pediatric patients, as well as     to assess the need of a special investigation and a post-marketing clinical study:        -  The frequency of treatment related adverse events.        -  The frequency of efficacy assessment.        -  Treatment related unlisted adverse events in Japanese Package Insert.        -  Risk factors likely to affect the frequency of treatment related adverse event.   "
140886|NCT01440413|"     This is a prospective, non-randomized study which aims to evaluate the response to a     neoadjuvant chemotherapy according to the the antitumor immune response in localized breast     cancer.      40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4     anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.      Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated     and receive an adjuvant treatment which will both depend on the investigator's appreciation.      Blood sample will be collected on the first day of the first chemotherapy cycle, on the first     day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.      Tumor sample will be collected on diagnosis as much as possible and on surgery.      Patients will be followed during 5 years.   "
140812|NCT01441388|"     Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of     patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment     while the majority of patients will eventually develop evasive resistance and exhibit disease     progression while on therapy. It is proposed that mesenchymal-epithelial transition factor     (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute     significantly to VEGF inhibitor resistance such that combining a c-MET inhibitor with a VEGF     inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This     hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with     individual VEGF inhibitors. Three combinations will be prioritized, namely crizotinib plus     axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth     combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with     either axitinib and/or sunitinib.   "
140813|NCT01441375|"     This study is a retrospective chart review of sickle cell patients and will include patients     whom have received blood transfusions and those whom have not. Of the transfused patients, it     will also include those whom have received chelation therapy and those whom have not.   "
140814|NCT01441362|"     The purpose of this study is to devise the method to reduce laryngeal injuries during     double-lumen tube intubation.   "
140815|NCT01441349|"     The purpose of this study is to compare the efficacy of Simvastatin and Irinotecan/Cisplatin     chemotherapy with Irinotecan/Cisplatin chemotherapy alone in Extensive disease-small cell     lung cancer.   "
140816|NCT01441336|"     Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric     cancer, there have been few reports of the efficacy of LAG in the management of advanced     gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic     safety of laparoscopic gastrectomy for AGC.   "
140817|NCT01441323|"     The investigators are conducting an intervention study to examine the effects of a 16-week     exercise and diet interventions on prevention of disease, specifically type 2 diabetes and     heart disease, in African American youth. Sixty overweight African American boys and girls     will be recruited and placed in one of the following intervention groups: 1) Control Group     (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing     sugar & soda, increased fiber & whole grain intake), or 3) Combination of Strength Training     (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary     Education (nutrition education focused on reducing sugar & soda, increased fiber & whole     grain intake). The investigators will assess which intervention group has the most effects on     health parameters such as weight, body composition, and insulin related measures.   "
140818|NCT01441310|"     There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer     sentinel node mapping.      The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy     with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green     (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.   "
140819|NCT01441297|"     Although chemotherapy is the primary treatment option for small cell lung cancer (SCLC),     longterm survival is rare. SCLC is initially chemosensitive, but rapidly relapses in a     chemoresistant form with an overall survival of <5%. Consequently, novel therapies are     urgently required and will likely arise from an improved understanding of the disease     biology. Some preclinical studies have showed that fibroblast growth factor-2 induces     proliferation and   "
140820|NCT01441284|"     Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter     study evaluating the efficacy of pramipexole on essential tremor.   "
140821|NCT01441271|"     The investigators hypothesize that minimally invasive ileal diversion with intraoperative     colonic lavage using a high volume polyethylene glycol/electrolyte solution will clear     Clostridium difficile infection resulting in eradication of Fulminant C. difficile colitis     (FCDC) while preserving the colon. Furthermore, the investigators hypothesize this will     reduce morbidity and mortality compared to total abdominal colectomy.   "
140822|NCT01441258|"     Harley and colleagues demonstrated that adding Dialectical Behavior Therapy (DBT)     skills-groups and therapist consultation to treatment as usual successfully reduced symptoms     of depression. The present study will expand upon these findings. Second, DBT is not known     for reducing suicidal ideation (SI), a major risk factor for suicide . The present study will     tailor the aforementioned skills-groups to specifically target suicidal thoughts and     behaviors through Cognitive Behavior Therapy (CBT) strategies aimed at increasing     problem-solving deficits, hopelessness, and negativistic thinking. Third, the present study     will extend this DBT-based approach to a novel population. Fourth, the present study is the     first DBT intervention to employ state-of-the-art multi-method measurement (including     objective assessment) of suicidal thoughts and behaviors.      The investigators hypothesize that participants in the DBT skills (DBT-S) group will show     improvements in level of suicidality as measured by decreased scores on the Beck Scale for     Suicide Ideation as compared with participants in the Wait List-Treatment as Usual (WL-TAU)     group.   "
140823|NCT01441245|"     Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion     and systemic fluid overload. In theory, continuous infusion should allow for a more     consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the     neurohormonal activation. This should lead to renal function improvement and BNP decrease.   "
140824|NCT01441232|"     This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211     when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes     Mellitus.   "
140903|NCT01440192|"     The primary objective of the study is to assess the safety and tolerability of a single dose     of PDA001 (given twice) in subjects with Stage II or III Pulmonary Sarcoidosis (PS) who are     refractory to one or more of the following treatments for PS: methotrexate,immunosuppressants     or cytotoxic agents.   "
140904|NCT01440179|"     Primary Objective:      Participants achieving an Objective Response Rate      Secondary Objectives:        -  Response duration        -  Progression Free Survival        -  Minimal residual disease        -  Safety        -  Pharmacokinetics   "
140950|NCT01439581|"     To determine if a device that measures and displays pressure that the patients feel when in     bed can help nurses reposition the patient effectively and thereby reduce bedsores in the     intensive care unit.   "
140825|NCT01441219|"     Obscure gastrointestinal bleeding (OGIB) has been one of the most challenging area in the     field of gastroenterology, as small bowel is beyond the reach of ordinary endoscopes like     oesophagogastroduodenoscopy (OGD) and colonoscopy. Thanks for the latest technological     advancement for investigating small intestine, we are now capable of obtaining intraluminal     images safely through capsule endoscopy (CE). Its role in obscure gastrointestinal bleeding,     Crohn's disease and other small bowel pathologies has already been proven, and nowadays it is     suggested by various authorities to be the first-line modality among all small bowel     investigations.      The investigators group has showed that CE can alter the clinical management of patients with     OGIB - patients with negative CE has lower rebleeding rate, and therefore we may adopt a     conservative approach for them. Although supported by some other group as well, conflicting     results were still reported in the literature about the out-come of these patients. The main     criticisms for these studies are that, CE can only identify 61% of the underlying small bowel     bleeding pathology, and one can never ascertain the outcome of patients with negative CE     examination. Apparently there is still room for improvement in the current CE technology.   "
140826|NCT01441206|"     The purpose of this study is to learn more about the safety and dosing of rifampin in     infants.   "
140827|NCT01441193|"     This Phase I study was directed at evaluating the safety profile and the immunogenicity of     the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins     administered in association in healthy, immunologically competent adults, compared to     delta-V2 Env or Tat alone.   "
141001|NCT01438918|"     The objective of this 2-year study is to evaluate the safety, tolerability and disease     modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS). The     efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the     medial tibiofemoral compartment of the study knee as the primary endpoint.   "
140828|NCT01441180|"     Background:      - GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by     blocking the hepatitis C virus from dividing in the body. This medication has been used along     with other medications commonly used to treat hepatitis C, such as interferon and ribavirin.     When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating     the hepatitis C virus from the body. However, interferon can have serious side effects, so     researchers want to see if GS-7977 can work by itself or with only ribavirin.      Objectives:      - To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis     C infection.      Eligibility:      - Individuals at least 18 years of age who have hepatitis C with liver disease, and have     never received drugs for it.      Design:        -  This study will require multiple clinic visits over 18 months. A liver biopsy will be          required before the start of the study if participants have not had one within the past          3 years.        -  Participants will be screened with a medical history and physical exam.        -  Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken          by mouth once a day. Ribavirin is taken by mouth in the morning and evening.        -  Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will          involve regular blood tests and symptom monitoring.        -  After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12,          16, and 20. Blood and urine tests will be given to study virus levels in the body, and          symptoms will be discussed.        -  Participants will stop receiving the study drugs at Week 24.        -  Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and          72. Another liver biopsy will be performed at 48 weeks.        -  Some participants may also be part of a smaller study. This study involves frequent          blood draws to study drug and virus levels in the blood. The study will require a          36-hour hospital inpatient visit.   "
140829|NCT01441167|"     Background:        -  Malaria parasites are carried by mosquitoes, which spread the infection by biting          people. Currently, there is no effective malaria vaccine. However, studies show that          volunteers bitten many times by mosquitoes that carry weakened malaria parasites could          fight off getting sick with malaria when later exposed to normal malaria parasites.          Malaria parasites are weakened by exposing them to radiation when they are in the stage          of development called sporozoites . Only the mosquitoes are irradiated and study          volunteers are not exposed to radiation. The radiation stops the parasites from being          able to cause disease but still promote protection. For many years, it was not possible          to give these sporozoites to people as a vaccine since they could not be adequately          purified from the mosquito. Scientists have recently figured out how to produce and          isolate the weakened sporozoites so that they can be given in an injected vaccine. This          vaccine is known as the PfSPZ vaccine.        -  A malaria challenge will be used to test whether the vaccine will prevent infection. In          a malaria challenge, mosquitoes that have the malaria parasite will be allowed to bite a          participant's arm. In the event that the vaccine does not work, the malaria parasite          used for the challenge can be treated completely with common anti-malaria medications.          Participants will be treated immediately if they develop malaria symptoms.      Objectives:      - To test the safety and effectiveness of the PfSPZ vaccine.      Eligibility:      - Healthy volunteers between 18 to 45 years of age.      Design:        -  Participants will be screened with a physical exam, medical history, and blood tests.          There will be five different groups of study participants, all of whom will be monitored          with frequent blood tests.        -  Group 1 will have two vaccines with the lowest amount of the vaccine given 4 weeks          apart, with regular clinic visits up to 24 weeks after the second vaccine. This group          will not have a malaria challenge.        -  Group 2 will have four or six vaccines given 4 weeks apart at a higher dose than group          1. A malaria challenge will be given about 3 weeks after the last vaccine. Follow-up          visits will continue through 24 weeks after the last vaccine.        -  Group 3 will have four or six vaccines given 4 weeks apart at a higher dose than group          2. A malaria challenge will be given about 3 weeks after the last vaccination, as for          Group 2. Follow-up visits will continue through 24 weeks after last vaccine.        -  Group 4 will have four or six vaccines given 4 weeks apart at a higher dose than group          3. A malaria challenge will be given about 3 weeks after the last vaccination. Follow up          visits will continue through 24 weeks after last vaccine.        -  Group 5 will serve as a control group and will not receive the vaccine, but will have          the malaria challenge. Follow-up visits will continue through 8 weeks after the          challenge.      All participants from any group who receive a malaria challenge will be treated promptly for     malaria when it develops.   "
140830|NCT01441154|"     Background:      - Thyroid hormone is produced by the thyroid gland, an organ at the base of the neck. Thyroid     hormone controls the body's metabolism and the function of many organs. The thyroid gland     produces two forms of thyroid hormone: T4 and T3. People who have thyroid cancer are treated     with thyroid hormone therapy (synthetic T4, levothyroxine), which at times needs to be     stopped to allow for cancer treatments. At these times, a different form of thyroid hormone     (synthetic T3, liothyronine) is used to reduce the symptoms caused by low levels of thyroid     hormone. Researchers want to know more about how changes in T3 hormone affect the body and     organ function.      Objectives:      - To study how changes in T3 hormone levels affect the body and organ function.      Eligibility:      - Individuals at least 18 years of age who have had most or all of their thyroid removed to     treat thyroid cancer who need to stop taking their regular thyroid hormone dose in     preparation for the treatment of thyroid cancer.      Design:        -  The study involves a screening visit and a baseline evaluation. It also includes an          11-day inpatient hospital stay.        -  Participants will be screened with a physical exam and medical history. They will also          have blood tests and a neck ultrasound.        -  Participants will be evaluated with a physical exam, blood tests, and the following          procedures:        -  Glucose tolerance test to measure blood sugar        -  Tests of body fat, muscle strength, and calorie burning levels        -  Imaging studies of the heart, liver, and thigh muscles        -  Quality of life questionnaires        -  Food preference and diet questionnaires        -  After 4 weeks of treatment with T3 hormone, participants will have an 11-day inpatient          hospital stay to study the effect of thyroid hormone on their metabolism. The stay will          involve the same tests done in the baseline evaluation.   "
140831|NCT01441141|"     Background:      - Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell pain     are known as crises. High rates of pain crises are associated with a higher risk of early     death. Some people with sickle cell disease have many severe pain crises while others     experience fewer crises. This difference in pain crisis may be caused by sensitivity to pain.     People with high sensitivity to pain may have more pain crises. Many factors, including a     person's genetic makeup, determine sensitivity to pain. Comparing genetic information from     people with sickle cell disease and healthy volunteers may provide more information on pain     and sickle cell disease.      Objectives:      - To study genetics and pain sensitivity in sickle cell disease.      Eligibility:        -  African or African American individuals at least 18 years of age with sickle cell          disease.        -  Healthy African or African American volunteers at least 18 years of age.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          provide blood and urine samples.        -  Participants will have the following tests:        -  Quantitative sensory testing to measure sensitivity to pressure, heat, cold, and          mechanical pain.        -  EndoPat test to measure blood vessel function and reaction.        -  Questionnaires about mood, evidence of depression, pain, quality of sleep, and sleep          disturbances.        -  Measures of daily pain, whether or not related to sickle cell disease.        -  After the first visit, those in the study will have monthly study visits for 6 months.          The above tests will be repeated at these visits.   "
140832|NCT01441128|"     Background:      - PF-02341066 and PF-00299804 are drugs that specifically target certain proteins that may be     more active in cancer cells than normal cells, in particular in non-small cell lung cancer.     Both drugs seem to be able to stop the growth of or kill cancer cells. Researchers want to     combine them to see if they are a safe and effective treatment for advanced non-small cell     lung cancer.      Objectives:      - To test the safety and effectiveness of PF-02341066 and PF-00299804 for advanced non-small     cell lung cancer.      Eligibility:      - Individuals at least 18 years of age with advanced non-small cell lung cancer that has not     responded to standard treatments.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood and urine tests, and imaging studies. Heart and lung function tests and an          eye exam may also be given.        -  The first cycle of treatment will be 28 days. Every cycle after the first will be 21          days. Participants may have up to 17 cycles of treatment.        -  Participants will take both study drugs as tablets. Twelve hours after the first dose,          participants will take only the PF-02341066. This dose schedule will remain the same          throughout the study.        -  Participants will be monitored with frequent blood and urine tests and imaging studies.          Tumor biopsies will be taken as needed. Those in the study will keep a diary to record          any symptoms or side effects of taking the study drugs.        -  After 17 cycles of treatment, or after stopping the study drugs early for any other          reason, participants will have a final followup visit.   "
140833|NCT01441115|"     Background:      - ECI301 is a drug that may help make cancer cells more visible to the immune system after     radiation. The drug may also help the immune system destroy the cancer at sites that have not     received radiation therapy. Researchers want to study ECI301 in people with advanced cancer     or cancer that has spread in the body (metastatic).      Objectives:      - To test ECI301 with radiation therapy for advanced or metastatic cancer.      Eligibility:      - People at least 18 years of age with either metastatic or advanced cancer that may benefit     from radiation therapy.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood and urine tests, and imaging studies.        -  All participants will have radiation therapy 5 days a week for 2 weeks.        -  They will have different doses of ECI301 to test its safety and effectiveness. ECI301          will be given in a vein during the second week of radiation therapy. Frequent blood          tests and imaging studies will monitor the treatment.        -  After participants have ECI301, tumor samples may be taken from the site that had          radiation and another site that did not have radiation.        -  Followup visits will include blood tests and imaging studies....   "
140834|NCT01441102|"     Background: Many people with diabetes have macular edema (swelling) at the back of the eye.     Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in     the swelling. A drug called dextromethorphan may help prevent the inflammation and the     swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been     studied to see if it can help in diabetic macular edema.      Objectives: To see if dextromethorphan can help treat diabetic macular edema.      Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least     one eye.      Design:        -  This study lasts 2 years, and will require at least 14 visits to the National Eye          Institute outpatient clinic. Study visits will be every month for the first 2 months and          then every other month. Each visit will take about 2 to 4 hours.        -  Participants will be screened with a physical exam, medical history, eye exam, and blood          tests. One eye with macular edema will be chosen as the study eye for testing.        -  Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years.          A study diary will help keep track of the date, time, and number of pills taken.        -  Participants will have study visits once a month for the first 2 months and then every          other month for the rest of the study. Each study visit will involve eye exams and blood          and urine tests.        -  Four months after starting the study medication, participants may have laser surgery or          other treatments for the macular edema, if it is needed.   "
140835|NCT01441089|"     Background:      - Some genes may be associated with a greater chance of side effects during cancer treatment.     These genes may also make certain treatments less effective. Researchers want to collect     blood or cheek swab samples from people having cancer treatment to study these genes.      Objectives:      - To obtain a blood or cheek swab sample to study genetic differences that may affect cancer     treatment.      Eligibility:      - Individuals with cancer who are being treated at the National Cancer Institute.      Design:        -  Participants will provide a blood sample for study.        -  Participants who have blood-based cancer, such as leukemia, will provide a cheek swab          sample.        -  If the blood or cheek swab sample does not have enough genetic material for analysis, an          additional sample may be collected.   "
140836|NCT01441076|"     Background:      - Behcet's disease (BD) is an autoimmune disease where the immune system attacks the body.     People with BD may develop oral or genital ulcers, skin problems, and eye disease. Most drugs     used to treat BD suppress the immune system, but they are not always helpful and may have     side effects. A new drug, anakinra, may be able to treat BD with fewer side effects. Because     it has not been studied in people with BD, anakinra is considered an experimental treatment.      Objectives:      - To test whether anakinra can be a safe and effective treatment for Behcet s disease.      Eligibility:      - People who have Behcet's disease with ongoing oral or genital ulcers for at least one     month, or three or more flares of eye disease in the past 6 months.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests. They will be divided into two groups: those with oral or          genital ulcers and those with eye disease.        -  All participants will keep a diary of symptoms for a month before starting the study          drug.        -  Participants with oral or genital ulcers will receive daily injections of anakinra for 3          to 6 months. Treatment will be monitored with frequent blood draws and daily diaries.          Those who improve but do not have a full response to the drug may receive a higher dose.          Those who improve after 6 months may have an extra 6 months on either anakinra or          placebo to study the differences in response.        -  Participants with eye disease will receive anakinra for up to 12 months. Treatment will          be monitored with frequent blood draws, daily diaries, and regular eye exams.        -  All participants will have a final study visit 1 month after stopping the study drug.   "
140837|NCT01441063|"     Background:      - KSHV-associated multicentric Castleman disease (KSHV-MCD) is caused by a herpes virus known     as KSHV. This disease can also cause several other cancers, including Kaposi sarcoma. People     with KSHV-MCD often have symptoms like fever, weight and muscle loss, and fluid in the legs     or abdomen. Tocilizumab may be able to block the chemicals in the body that cause KSHV-MCD     symptoms. Researchers want to test this drug and other anti-virus drugs to find the best     combination of drugs to treat KSHV-MCD.      Objectives:      - To test the effectiveness of tocilizumab with and without other anti-virus drugs for     KSHV-MCD.      Eligibility:      - People at least 18 years of age who have KSHV-MCD and have certain symptoms and blood     abnormalities caused by their KSHV-MCD.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood tests, and a skin biopsy.        -  Participants will have tocilizumab injections every 2 weeks for up to 12 weeks. They          will provide daily blood samples for the first 3 days of treatment.        -  After the sixth dose, participants will be monitored for 4 weeks to check for possible          side effects.        -  Those whose KSHV-MCD does not improve or worsens during the study may have tocilizumab          combined with two other anti-virus drugs, zidovudine and valganciclovir. These drugs are          pills that will be taken four times a day for 5 days out of every 2 weeks.        -  Blood, urine, and saliva samples will be collected throughout the study.   "
141137|NCT01437150|"     The purpose of this study is to determine whether this new anatomical locking plate is more     effective and easy to operate than other plate in the treatment of acetabular posterior wall     fracture.   "
140838|NCT01441037|"     Background:      - Some people have bone marrow and lung disorders that are caused by genetic problems. These     problems often involve damage to the ends of the chromosomes that pass down genes. One of     these disorders is aplastic anemia. This is a disorder in which the bone marrow does not make     enough blood cells. Currently, doctors use a male hormone-based drug called Danazol to     improve bone marrow function and treat aplastic anemia. More information is needed on whether     Danazol can help repair the damaged chromosomes that cause aplastic anemia and similar     disorders that cause low blood cell counts or lung problems.      Objectives:      - To study the safety and effectiveness of Danazol for bone marrow and lung disorders caused     by damaged genes.      Eligibility:      - Individuals at least 2 years of age who have low blood cell counts or lung fibrosis caused     by damaged genes.      Design:        -  Participants will be screened with a physical exam and medical history. Then they will          have blood and urine tests, imaging studies, and a lung function test. They will also          take a 6-minute walking test and have a bone marrow biopsy.        -  Participants will receive Danazol to take twice a day for the duration of the study.        -  Participants will have regular study visits at 6, 12, and 24 months, with blood tests,          imaging studies, a lung function test, and a 6-minute walking test. A bone marrow sample          will be collected at the 12-month visit.        -  Participants will remain on the study for up to 2 years. Researchers will follow up with          them for 2 years after the end of the study.   "
140839|NCT01441024|"     Background:      - Parainfluenza is a virus that can cause infections in people. Most people infected with     this virus have mild symptoms including fever, cough, red eyes, or runny nose (a common     cold). Some people, especially those with a weakened immune system, get very sick from this     virus. They may have difficulty breathing or develop lung infections. Currently, there are no     specific treatments for parainfluenza. However, a drug called DAS181 may make the virus go     away faster. Researchers are interested in testing DAS181 to see if it is safe and effective     against parainfluenza.      Objectives:      - To test the safety and effectiveness of DAS181 as a treatment for parainfluenza.      Eligibility:      - Individuals at least 18 years of age who have the parainfluenza virus and have developed     symptoms within the past 10 days.      Design:        -  Participants will be screened with a physical exam, medical history, and questions about          symptoms and activity levels. Participants will also have a lung function test and          provide blood and nasal fluid samples.        -  DAS181 is an inhaled medication, and everyone will receive a study medication inhaler.          Participants will receive either DAS181 or a placebo through the inhaler. They will take          it once every day for 5 days.        -  Participants will have monitoring visits on days 2, 4, 7, 10, 14, and 28 to provide          blood and nasal fluid samples and have a lung function test.        -  Participants who still have the virus in their system on Day 28 will return to the          clinic on Day 42 for more tests. Participants who still have the virus in their system          on Day 42 will return to the clinic on Day 56 for more tests.        -  Participants will have followup visits 6 months and 1 year after the start of the          study....   "
140840|NCT01441011|"     Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence     and death compared to their normal weight counterparts. Moreover, weight gain and decreased     physical activity are common after diagnosis and also increase the likelihood of breast     cancer recurrence and death. Rural women suffer from health disparities in breast cancer     diagnosis and treatment. Women of the most rural counties also have the highest prevalence of     obesity compared to urban women. To address these disparities, the overarching objective of     this proposal is to develop a clinically effective and cost efficient strategy for delivering     a weight control intervention to rural breast cancer survivors. Group phone-based treatment     via conference call is a novel treatment delivery approach that the investigators have shown     to be effective for initial weight loss among rural breast cancer survivors and more     effective than the standard individual phone-based approach among rural women. This     innovative method of providing group treatment addresses access barriers in rural areas and     may be especially ideal for rural breast cancer survivors because it provides social support     in conjunction with a level of anonymity. However, the impact of group phone counseling     during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss     maintenance is the more challenging phase of treatment when weight regain is common, and this     regain presents a potential risk for breast cancer recurrence. This randomized controlled     trial will evaluate the effects of group phone-based treatment for weight loss maintenance     among rural breast cancer survivors, compared to an established mail-based education     comparison condition, subsequent to a 6 month group phone-based weight loss phase for both     conditions. In addition to the intervention impact on weight loss maintenance, the study will     provide estimates of incremental cost-effectiveness per kg loss between the two conditions     and the impact on secondary outcomes including quality of life, breast cancer risk     biomarkers, dietary intake, and physical activity.   "
140841|NCT01440998|"     This pilot clinical trial studies how well dasatinib works together with paclitaxel and     carboplatin in treating patients with stage III, stage IV or endometrial cancer that has come     back after a period of improvement. Dasatinib may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing     the cells, by stopping them from dividing, or by stopping them from spreading. Giving     dasatinib together with paclitaxel and carboplatin may kill more tumor cells.   "
140842|NCT01440985|"     Participants will be smokers who want to quit, and have visible nicotine stains on their     teeth. They will be given toothpaste and a toothbrush to use during the study, and will have     an equal chance of being assigned to use either a nicotine gum or microtab. They will visit     the study site five times during the 12 week trial to have their teeth examined.   "
140843|NCT01440972|"     The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance     training program with concurrent application of partial blood flow restriction (PBFR) to the     exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in     women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be     change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators     will test the following hypotheses. In comparison with low-intensity resistance training     without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:      Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee     extensor strength      Secondary Hypotheses:        1. Increase quadriceps muscle volume assessed by MRI        2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed          stair climb        3. Not adversely effect knee pain or quality of life assessed by the Knee injury and          Osteoarthritis Outcome Score (KOOS) questionnaire   "
141002|NCT01438905|"     The purpose of this study is to examine the effects of a gentle pressure movement performed     at the ankle by a physical therapist on muscle function and ankle motion in individuals who     frequently twist (sprain) their ankle.   "
140844|NCT01440959|"     With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib     (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients     with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib     (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with     imatinib. However, virtually all patients will eventually progress or become intolerable     after the first-line imatinib and the second-line sunitinib. Dovitinib (TKI258, Novartis) is     a multi-kinase inhibitor. TKI258 is a potent inhibitor of the VEGFR 1, 2, and 3, FGFR1, 2 and     3, PDGFRβ, Kit, RET, TrkA, CSF 1R, and FLT3 with inhibitory concentration 50% (IC50s) of less     than 40nM. Stem cell factor (SCF) also termed KIT ligand, or steel factor has been shown to     modulate tumor angiogenesis. In cultured human endothelial cells and Kit expressing cancer     cells, TKI258 inhibits VEGF- and SCF-stimulated mitogenesis. .   "
140845|NCT01440946|"     The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation     Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia     B. Secondary objectives of this study in this study population are as follows: to evaluate     the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and     assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and     treatment of bleeding episodes   "
140846|NCT01440933|"     Sugammadex is a new reversal agent for neuromuscular blockers (curare). It encapsulates the     curare molecule and terminates immediately its action. The recommended dose is 2 mg/kg for a     slight neuromuscular block and 4 mg/kg for a profound neuromuscular block. Magnesium sulphate     is frequently used in perioperative medicine and it is known to reinforce the neuromuscular     block induced for instance by rocuronium. The researchers want to investigate, whether higher     doses of sugammadex must be given to antagonize the neuromuscular block induced by rocuronium     in patients who received magnesium sulphate.   "
140847|NCT01440920|"     The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with     acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who     completed a standard consolidation therapy.   "
140848|NCT01440907|"     The purpose of this research study is to evaluate the effect of a health information exchange     (HIE)-supported care coordination package on 30-day readmission rates in a frail elderly     population.   "
140849|NCT01440894|"     The clinical protocol of the clinical testing of this device:        1. Objective of the test: To verify the functions and efficiency of devices.        2. Test methods and procedures: Comparison Test.        3. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012,          BF-1039, BF-1041-A, and GBF-950-D.        4. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).        5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.        6. Statistical methodology used: Description of statistical methods.        7. Result: Efficiencies of Transtek devices and predicate device are in the same level.   "
140850|NCT01440881|"     This project evaluates whether nesiritide, human recombinant brain natriuretic peptide,     confers renal protection during cardiovascular surgery by attenuating the inflammatory     response.   "
140851|NCT01440868|"     BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the     efficacy of the respiratory effort in lung of preterm infants at risk for respiratory     distress syndrome (RDS) and reduce need of mechanical ventilation (MV).      The investigators aim will be to demonstrate the hypothesis that the introduction of SLI in     the delivery room protocol may reduce the need of MV in preterm infants.      STUDY DESIGN: Multicenter prospective randomized controlled trial. The study will be carried     out at the neonatal care units of the Careggi Infants with a gestational age between 25 and     28 weeks will be eligible and randomized at birth to receive SLI or not. Peak inflation     pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a positive     end expiratory pressure (PEEP) of 5 cm H2O.      Primary endpoint will be the need of MV within the first 72 hrs of life (excluding the     transient tracheal intubation for surfactant replacement: e.g. INSURE). Population size:     hypothesizing that SLI maneuver might decrease the need of MV during the first 72 hours of     life from 35 to 20% the investigators calculated that 138 newborns must be enrolled in each     groups to detect this difference statistically significant with 80% power at 0.05 level.   "
140852|NCT01440855|"     This study was designed to provide a preliminary evaluation of the efficacy and usability of     the 2004 revised version of the booklet, Facing Forward , Life After Cancer Treatment,     (hereafter,Facing Forward) published by the National Cancer Institute. Facing Forward     provides early stage cancer patients during the period after completing active treatment     practical ways of dealing with common problems, including guidelines for managing physical,     social, and emotional health. Assessments were completed at the patient's final cancer     treatment visit. Follow-up assessments occurred eight weeks and 6 months later. The initial     assessments covered background information (demographics, medical status), use of educational     materials, survivorship activities, and psychological factors. The follow-up assessments     included use of actions recommended in Facing Forward, ratings of Facing Forward with respect     the booklet's informativeness, helpfulness, understandability, and extent read, the same     psychological measures used initially, and a measure of self-efficacy.   "
140853|NCT01440842|"     The purpose of this study is to assess the efficacy, safety and feasibility of a     computer-based control algorithm to control glucose levels in adults in intensive care unit,     in comparison to standard care.   "
140868|NCT01440647|"     Very premature infants often cannot breathe on their own and require assistance with a     respirator. Conventional respirators deliver air or oxygen via a breathing tube placed     through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube     is associated with injury to the lungs. Currently, a premature baby has to be ventilated     through an endotracheal tube until he/she can fully breathe independently. In the current     study, in order to shorten the time with an endotracheal tube, we utilized an alternative,     less invasive ventilation procedure, nasal intermittent positive pressure ventilation     (NIPPV). This procedure provides help with breathing, but requires only nasal, not     endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage     in their recovery, when they could not breathe independently yet. Thus, by switching babies     at this early stage from a regular respirator to NIPPV, we should be able to shorten the use     of an injurious endotracheal tube.   "
140856|NCT01440803|"     Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise     completely healthy individuals with no secondary cause of bone loss. In the course of our     prior research with premenopausal women with IOP, the investigators have shown that women     with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to     normal women. Additionally, using noninvasive high resolution imaging of the central and     peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the     investigators identified several features of bone quality in premenopausal women with IOP.      There is currently no FDA-approved therapy for IOP in premenopausal women. However,     teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in     postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well     as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis.     Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of     about 113,000 in the United States, pharmaceutical companies are unlikely to support     development of therapies for this indication. Therefore, the major objective of this protocol     is to establish the safety and efficacy of teriparatide in premenopausal women with IOP in a     phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a     randomly selected group of patients (10) will receive one year of placebo injections first     before starting their two years of treatment. The remainder of subjects (30) will receive     active drug only for two years.      Funding Source - FDA OOPD   "
140857|NCT01440790|"     The objective of this study is to determine the effect of reducing the rate of glucose     absorption on oxidative stress after eating and to compare it with the effects of vitamin C.     The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress     to a similar extent as 1g vitamin C.   "
140858|NCT01440777|"     This research will examine the effectiveness of a 6-week online sleep program (Go! To Sleep)     which provides a set of various psycho-educational materials and behavioral techniques to     reduce insomnia symptoms, improve sleep, and improve quality of life.   "
140859|NCT01440764|"     The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a     treatment that has the potential to significantly improve symptom management and enhance the     quality of care for patients with intractable dyspnea.   "
140860|NCT01440751|"     The objective of this prospective randomised study is to compare the efficacy and safety of     ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in     uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety     being the secondary.   "
140861|NCT01440738|"     Objectives      Main objective: Assessing the effectiveness of the health workshops, in terms of quality of     life.      Secondary: To determine the effectiveness of the health workshops in relation to: Increase     knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced     diet. Incorporate and maintain regular physical activity; Keep variables related to risk     factors (BP, Weight, Cholesterol) within normal limits, reduce cardiovascular risk (RCV). To     estimate costs.      Methodology      Design: randomized controlled trial comparing a group of patients who performed the health     workshops with a control group with similar characteristics.      Scope of the Study: The study was conducted in 54 health centers of Barcelona city.      Subjects of study: general population between 18 and 65 years who consent to. 188 people with     speech (have conducted workshops for health) and 188 people without (not made health     workshops. Data Analysis: T- test to compare the differences between quantitative variables     or equivalent non-parametric if the distribution of the variable does not meet criteria of     normality (Kolmogorov-Smirnov).   "
140862|NCT01440725|"     This is a multicenter, simple blind, masking of outcomes assessors, parallel, randomised     clinical trial in patient with muscle rupture and with hematoma production. The main     hypothesis is that infiltration in the area of muscle injury in autologous platelet-rich     plasma (PRP)improves muscle regeneration and repair by shortening the time to complete     recovery.      The main objective is to evaluate the PRP for healing muscular lesions 'tennis leg' type or     distal rectus femoral. The secondary objectives are: to evaluate the risk of lesion     recurrence; to evaluate the quality of lesion recovery process and evaluate intervention's     safety.      Experimental treatment will be the administration of PRP autologous (4-8 cc in a unique dose)     by muscular infiltration en the empty space generated after the hematoma evacuation. Control     treatment will be hematoma evacuation. Both treatment groups will use compressive bandage and     they will recommend rest, extremity elevation, local ice and lately physiotherapy.      Size sample: 76 patients (38 in each group)   "
140863|NCT01440712|"     The purpose of this trial is to determine whether the water-soluble contrast (gastrografin)     is more effective in the treatment of postoperative ileus than the conventional one.   "
140864|NCT01440699|"     Adipose-derived stem cells have properties of differentiation to various types of cells,     immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.      Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in     Phase I and II study on the patients with Crohn's fistula.      However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing     ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and     efficacy in patients with Crohn's fistula.   "
140865|NCT01440686|"     The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of     HL-032 after oral administration in healthy male volunteers.   "
140866|NCT01440673|"     -  Gynecological surgery is associated with a high incidence of postoperative nausea and          vomiting.        -  NK1 receptor antagonists such as aprepitant appear to be highly effective for treating          acute and delayed emesis, and yet understanding of the efficacy of different doses of          aprepitant is limited.        -  We performed a prospective, randomized, double-blinded placebo-controlled study of 123          female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125          mg aprepitant, or a placebo.   "
140867|NCT01440660|"     To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using     multimodal testing/imaging procedures.   "
140905|NCT01440166|"     -  To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative          to placebo in healthy adult volunteers.        -  To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy          adult volunteers.        -  To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult          volunteers.   "
140869|NCT01440634|"     Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results     from progressive atherosclerosis of arteries in the lower extremities. PAD is also associated     with major detrimental effects on quality of life and functional status, and is the most     important cause of limb amputation. More importantly, PAD is a major manifestation of     cardiovascular disease and a potent predictor of myocardial infarction, stroke and death.     Despite its frequent occurrence, little is known about the natural history of PAD in     Hispanics who represent 12.5% of the United States. Because access to health care is limited     among Hispanics, CBPR is the ideal process to reach this target population. The goal of the     proposed study is to evaluate community-based strategies of detection and treatment of     peripheral arterial disease (PAD) in Hispanics. The proposed project consists of two phases:     a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD     detection study , the prevalence and severity of PAD in this population will be determined.     Specific risk factors associated with PAD among the Hispanic participants will be identified.     During the second phase patients will be enrolled in a randomized, non-blinded trial     comparing a community-based risk factor modification and supervised exercise program versus     usual care for PAD. These individuals will undergo a baseline evaluation similar to the one     obtained during the first phase of the study, but will also include functional testing of the     lower extremities.   "
140870|NCT01440621|"     Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among     patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in     itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue     which persists even after rest and has significant effects on quality of life.      The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with     almost every patient on radiotherapy complaining of at-least some magnitude of fatigue.      Given that fatigue can affect treatment adherence by patients, it is important to initiate     measures to either prevent or mitigate Cancer Related Fatigue.      The investigators intend to use modafinil in cancer related fatigue, in view of the fact that     it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and     fibromyalgia. In addition, there have been a few small trials which have hinted towards     benefit with the use of modafinil in cancer related fatigue.      The investigators have chosen a dose of 100mg/day in the morning, to be compared with     placebo. The study arm and the placebo arm will be stratified with respect to age, sex,     disease site, baseline performance status.      Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue     Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance     status, changes in systolic and diastolic blood pressure, and changes in weight.   "
140871|NCT01440608|"     The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc     therapy and de-worming albendazole as separate interventions in restoring normal gut     absorptive and immunological function as measured by the dual sugar permeability test and     additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental     Enteropathy.   "
140872|NCT01440595|"     This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir     (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin     (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3)     hepatitis C virus (HCV) infections.   "
140873|NCT01440582|"     The goal of this clinical research study is to find the highest tolerable dose of the drug     panobinostat that can be given in combination with the drugs Velcade (bortezomib), Revlimid     (lenalidomide), and Decadron (dexamethasone) to patients with MM. The safety of this drug     combination will also be studied.      Panobinostat is designed to cause chemical changes in different groups of proteins that are     attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or     cause the cancer cells to die.      Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer     cells to die.      Lenalidomide is designed to change the body's immune system. It may also interfere with the     development of tiny blood vessels that help support tumor growth. This may slow the growth of     cancer cells.      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.     Dexamethasone is often given to MM patients in combination with other chemotherapy to treat     cancer.   "
140874|NCT01440569|"     This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus     two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected,     antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV)     resistance-associated mutations.      After the Week 48 Visit, participants will be given the option to participate in an     open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it     becomes commercially available, or until Gilead Sciences elects to terminate development of     cobicistat.   "
140916|NCT01440023|"     Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor     cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate     response such as vocal or motor tics. The investigators aim to test whether a     well-established behavior therapy for TS can be improved by increasing the individual's RI     capabilities. To this end, 20 children will be randomly assigned to behavior therapy with     computer-based RI training or behavior therapy with placebo computer-based cognitive     training. The investigators will test the hypothesis that computer-based RI training can be a     useful addition to the well-established behavior therapy to enhance its therapeutic effect.   "
140952|NCT01439555|"     Purpose of the study: Patients with mild Alzheimer's Disease will be given three different     drugs over a 4-month period to try to increase the blood flow to their brains, and improve     blood vessel and brain function. Each drug can help to open the blood vessels in the brain,     and together they may be more effective than each drug alone. The hypothesis is that small     blood vessels secrete substances that maintain the integrity of the brain, and may prevent     loss of nerve cells leading to Alzheimer's Disease   "
140953|NCT01439542|"     The purpose of this study is to examine the safety of a shorter course of radiation     treatments combined with one year of androgen deprivation therapy. The study will test this     treatment in men with high risk prostate cancer who have significant other illnesses or     circumstances such that conventional long term radiotherapy and hormone therapy is not     recommended by their physician or desired by the patient.   "
140875|NCT01440556|"     Autologous hematopoietic cell transplantation is currently considered the standard therapy of     multiple myeloma (MM) for elegible patients. On the contrary, despite new developments in     transplant procedures and supportive care, allogeneic bone marrow transplantation is less     commonly used due to high transplant related mortality (TRM).      No consensus statement about allografting in MM has so far been reached and only a minority     of patients undergoing allografting are enrolled in prospective clinical trials.      Moreover, use of unrelated donors is considerably increased over the time and the recent     activity survey of European Group for Blood and Marrow Transplantation (EBMT) showed that the     number of allografts from unrelated donor is higher than that one from HLA-identical siblings     in Europe.      In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients,     the investigators plan to conduct a restrospective study through the Italian Bone Marrow     Transplantation Registry (IBMDR) over a period ranging since 2000 to 2009. Data will be     collected from the central data management system Promise (Project Manager Internet Server)     used by EBMT and from IBMDR.      The aim of the study is to evaluate the role of unrelated donor allograft in multiple myeloma     over the last decade and hopefully offer recommendations on patient selection. Primary     endpoints of the study are: a) Overall Survival (OS) from diagnosis and from the allograft b)     Event-Free-Survival (EFS) from the allograft. Disease response criteria will be defined     according to the International Uniform Response Criteria for multiple myeloma. Transplant     related mortality, Graft-Versus-Host-Disease (GVHD), either acute or chronic     (limited/extensive) will be evaluated as cumulative incidences. Univariate and multivariate     analysis will be calculated for the transplant-related and patient-related characteristics.   "
140876|NCT01440543|"     Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as     alternative colonoscopy techniques have been documented to decrease patient discomfort during     and after the procedure.      This prospective, randomized, single-center trial was designed to evaluate whether the     combination of water immersion during insertion and CO2 insufflation during withdrawal     (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other     colonoscopy methods (Water/Air, CO2/CO2, Air/Air).   "
140877|NCT01440530|"     The purpose of this 3 site, 24-week, Comparative Effectiveness Randomized Clinical Trial in     Primary Care is to compare usual care to an online, multi-media, digital intervention for     Persons with Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care.   "
140878|NCT01440517|"     The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in     diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart     Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged     with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic     dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with     99mTc-maraciclatide.   "
140879|NCT01440504|"     The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 +     association platinum in samples exposed and demonstrate the value of this combination     compared to the agents used alone.   "
140880|NCT01440491|"     The aim of this study was to evaluate the effect of exercises performed under monitoring of     the physiotherapist and self performed at home by reading the booklet of exercise orientation     for patients with nonspecific low back pain.      A prospective and randomized trial was performed in 44 patients. G1 patients received a     physiotherapist orientation, and G2 patients received the booklet of exercise to self perform     the exercises. Pain intensity by Visual Analogue Scale (VAS), and quality of life by SF-36     were measured before.      Results: Pain intensity was lower in G1 than in G2 after 6 and 12 weeks. Quality of life was     better in G1.      The exercises under orientations of the physiotherapist promoted best effect than self     performed exercises .   "
140881|NCT01440478|"     This study is designed to explore the effect of increased and decreased urinary pH on the     single pharmacokinetic (PK) dose of LY2140023 and its active metabolite LY404039. All     participants will receive the three treatments in a randomized order.   "
140882|NCT01440465|"     The objective of this study was to evaluate the various parameters involved in the occurrence     of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic     among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.   "
140883|NCT01440452|"     This research is being done to see how different amounts of Functional Electrical Stimulation     (FES) affect cycling on factors in blood and spinal cord in people with spinal cord     inflammation.   "
140884|NCT01440439|"     Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes     like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes     are treated with a basal bolus insulin regimen, with background insulin provided by     long-acting basal insulin doses, and bolus doses of short-acting insulin used to     accompany food intake. Evidence shows that the main factor preventing people with diabetes     from pursuing a more active lifestyle is fear of low blood glucose (hypoglycaemia). A     previous study has shown that the type of background insulin affects the likelihood of an     individual suffering hypoglycaemia during exercise and for 2 and a half hours afterwards. The     aim of this study is to examine this further.      The two most commonly used long-acting insulins, insulin glargine and insulin detemir, will     be compared. Previous data suggests that there is a greater likelihood of hypoglycaemia with     insulin glargine than insulin detemir. Exercise intensity can have an influence on the     likelihood of hypoglycaemia, and in this previous study exercise intensity was measured using     heart rate. This study will use a more formal definition of exercise intensity. The     investigators will study blood glucose during exercise, but also metabolism as measured by     hormones affecting blood glucose levels as well as markers of fat metabolism. The     investigators will also use a continuous glucose monitoring system (CGMS) to consider     hypoglycaemia on thei night following exercise as this is a recognised consequence of     exercise in type 1 diabetes.      The null hypothesis to be tested in this study is that there is no difference between the two     insulins in their effect on blood glucose levels and metabolism during exercise and rates of     nocturnal hypoglycaemia after exercise.   "
140885|NCT01440426|"     This study deals with coverage of multiple denuded roots. The current standard treatment     requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance     results. The hypothesis of this trial is that a synthetic collagen matrix (called Mucograft)     can be used to replace soft tissue taken from the subject. If the collagen matrix will prove     to be equally as effective as the patient own tissue, it will be possible to avoid a more     extensive surgery and decrease pain and discomfort.   "
140917|NCT01440010|"     Quality control of IORT as a boost with 20 Gy followed by EBRT   "
140951|NCT01439568|"     The purpose of this trial is to compare the progression free survival of LY2510924 +     carboplatin + etoposide therapy versus carboplatin + etoposide therapy in patients with     extensive-stage disease small cell lung cancer (SCLC)   "
140887|NCT01440400|"     The classical method for spinal anesthesia relies on the use of bony landmarks to identify     the level and point of entry of the spinal needle. Over the years, in experienced hands, this     method consistently proved to be successful and safe.      The introduction of ultrasound to guide neuraxial anaesthesia into clinical practice was     relatively slow compared to peripheral nerve blocks or central venous catheterization. This     could be due to the technical difficulties posed by the bony structures surrounding the     spinal cord and its dura that blocks the path of the ultrasound beam. Many anesthetists are     reluctant to change their conventional landmark technique, particularly with most studies     showing no change in the success rate between ultrasound guided and the landmark techniques.      Several studies however showed that the ultrasound guided approach reduces the number of     attempts to achieve a successful block and reduces the procedure time particularly in obese     patients and those with technical difficulties.      In this study the investigators are trying to answer the following question : Is there any     advantage in using ultrasound to guide spinal anaesthesia in non obese obstetric patients     with easily palpable bony landmarks?   "
140888|NCT01440387|"     The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline     (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in     adults 18 years of age and older.   "
140889|NCT01440374|"     This was a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part     3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with     myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia due     to bone marrow insufficiency from their underlying disease or prior chemotherapy. This     objective was assessed by a composite primary endpoint that consists of the following: the     proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts <10 Gi/L, or platelet     transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone marrow     insufficiency from their underlying disease or prior chemotherapy were enrolled in the study.     No low or intermediate-1 risk MDS subjects were enrolled in the study. Subjects must have had     at least one of the following during the 4 weeks prior to enrolment: platelet count <10 Gi/L,     platelet transfusion, or symptomatic hemorrhagic event. Supportive standard of care (SOC),     including hydroxyurea, was allowed as indicated by local practice throughout the study. The     study had 3 sequential parts. Subjects who were enrolled in Part 1 (open-label) cannot be     enrolled in Part 2 of the study (randomized, double-blind); however, subjects who completed     the treatment period for Part 1 or Part 2 (8 and 12 weeks, respectively) continued in Part 3     (extension) if the investigator determined that the subject was receiving clinical benefit on     treatment.   "
140890|NCT01440361|"     Chronic immune thrombocytopenia (ITP) is a longterm disease in which the blood does not clot     normally. This is due to a low number of blood cell fragments called platelets. Platelets     clot to seal small cuts or breaks on blood vessel walls and stop bleeding. Normally the     immune system makes proteins called antibodies to fight off harmful substances that enter the     body. In ITP, the immune system produces antibodies that attack and destroy the body's     platelets by mistake.      Patients can suffer from bleeding under the skin, nosebleeds, blood in urine or stools and in     very severe cases bleeding in the brain. Patients have an increased frequency of death from     bleeding complications compared to normal.      Chronic ITP is fairly rare , with an incidence of 32 new cases/million people each year.      Existing treatments work by lowering the activity of the immune system or directly increasing     platelet count. These treatments do not work effectively in all patients and can have side     effects. We hope that understanding how belimumab works in ITP will help in the development     of future treatments for ITP and other autoimmune diseases.      We will test the safety, blood levels and effects of the study medication in people with     chronic ITP. Patients will receive the study medication intravenously (through a needle     inserted into a vein) and blood samples will be taken before and on several occasions     afterwards.      Up to 40 patients with chronic ITP, aged 18 to 75 will participate. Approximately 11 patients     will take dummy medicine instead of the study medicine neither they or their study doctor     will know which one they are given. Participants will take up to 57 weeks to finish the     study. They'll make 12 outpatient visits.      The study will take place in hospitals in the UK. Other sites in mainland Europe may also be     initiated.      A pharmaceutical company, GlaxoSmithKline, is funding the study.   "
140891|NCT01440348|"     This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a     single free tendon Achilles allograft using new technique.   "
140892|NCT01440335|"     Background:      - Fenoterol has been used to treat asthma by opening up the airways in the lungs. It also     increases the heart rate without significantly increasing blood pressure. This means that it     may help improve heart function by boosting the heart's output. Researchers have developed a     different form of the drug that may be given to individuals with heart trouble. This new form     needs more testing. It is especially important to compare the new form with the original form     of the drug used to treat asthma.      Objectives:      - To compare how safe and effective two different forms of Fenoterol are in improving heart     function.      Eligibility:      - Healthy people between 21 and 60 years of age who have no history of heart disease.      Design:        -  People will be screened with a medical history, physical exam, blood and urine tests,          and heart function studies.        -  Those in the study will have two 36-hour inpatient study visits. At each visit, they          will have a physical exam and blood and urine tests. They will fast overnight and then          receive one of the two forms of Fenoterol first thing in the morning. They will not know          whether they are getting the original or the modified form of the drug. After receiving          the drug, they will provide frequent blood and urine samples for 24 hours. They will          have a final exam before being discharged.        -  Those who take part in the study will have a followup visit 5 to 7 days after the end of          each study visit. They will provide more blood and urine samples and have a physical          exam.   "
140893|NCT01440322|"     The purpose of this study was to evaluate the subjective and objective performance and the     physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA     contact lenses in participants with normal eyes and prescription needs.   "
140894|NCT01440309|"     The study is designed to evaluate the safety and efficacy of intravenous administration of     bone marrow derived mesenchymal stem cells for patients with refractory primary biliary     cirrhosis (PBC).   "
140945|NCT01439646|"     Retrospective, observational study To study the effect of Empirical Antifungal therapy on     clinical outcome in high risk patients with suspected Invasive Fungal Infection admitted in     ICU/Critical care unit, To know the current epidemiology of IFI and management approach in     patients at high risk of Invasive fungal infections, Identify the risk factors associated     with Invasive fungal infections, To comment on the appropriateness of empirical therapy used     based on proven/probable diagnosis   "
140895|NCT01440296|"     The Canadian Atherosclerosis Imaging Network (CAIN) is a pan-canadian imaging network funded     through grants from the Canadian Foundation for Innovation (CFI) and the Canadian Institutes     of Health Research (CIHR). This unique research network is focused on the pathobiology of     atherosclerotic disease as it pertains to the coronary and carotid circulations. The CAIN     research program involves the creation of a unique national network focused on in vivo     imaging of vessel wall disease, combined with imaging of occult end-organ disease as well as     the acquisition of clinical and pathological end points. CAIN enables unprecedented     cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease in     coronary or carotid vascular beds, and has established an international resource for studying     the natural history, progression, regression and novel therapeutic interventions aimed at     atherosclerosis.      The primary outcome of this study is to accurately characterise carotid plaque morphology in     non-surgical patients with mild to severe (30-95%) carotid disease. The investigators will     also assess evidence of ischaemic brain disease. Patients will undergo MRI scanning of the     brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years     or sooner if presenting clinically in order to monitor the natural history of carotid     atherosclerosis and its effect on end-organ brain disease.      Patients will consent to baseline scanning and follow up at 1 and 2 years, and databasing of     clinical and imaging data. After each imaging session images will be processed, stored     locally and also sent to a central repository. 500 patients will be recruited over a 2 year     period in anticipation of study completion within 4 years.   "
140896|NCT01440283|"     High risk neuroblastoma (NB) is an aggressive, prevalent non-brain cancer derived from nerve     cells of the body. It mostly affects infants, and more children die from this tumor each year     than are cured. Standard therapy includes a combination of chemotherapy, surgery, bone marrow     transplant, radiation and immunotherapy. NB is very sensitive to radiation, but due to it's     aggressive spread pattern, radiation use is currently limited by toxicity. This study seeks     to improve delivery of radiation to reduce toxicity by quantifying outcomes, and measuring     differences in renal toxicity and organ motion so that radiation can be focused more     effectively against tumor while sparing normal tissues and reducing side-effects.   "
140897|NCT01440270|"     Epidermal growth factor receptor（EGFR） is a potential target for new anticancer therapy in     head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody     results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell     proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The     study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and     radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on     prognosis. The endpoints of this study are the pathological complete response after     neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival     rate, and the safety.   "
140898|NCT01440257|"     The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary     albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to     study the safety and efficacy of the medication in this patient population.   "
140900|NCT01440231|"     Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune     system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells     make proteins called antibodies, which in autoimmune disease can bind to one's own tissues     and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called     BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus     the production of antibodies. This study will assess whether treatment with atacicept can     reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not     available outside of a clinical trial, and that its potential benefits and risks have not     been fully determined.      A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a     1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept     115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.      The primary objective of the trial is to evaluate the efficacy of atacicept compared to     placebo in reducing SLE disease activity in subjects treated with standard of care (SoC)     therapy and to investigate the dose-response relationship.      The secondary objectives of the trial are:        -  To evaluate the effect of atacicept in reducing corticosteroid usage        -  To evaluate the safety and tolerability profile of atacicept in subjects with SLE        -  To confirm the PK and PD profiles of atacicept in SLE subjects        -  To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey          [SF-36].   "
140901|NCT01440218|"     This research is being done to learn more about possible genetic causes of currently     undiagnosed conditions, and to find out how the development of new technologies, such as DNA     sequencing, can increase knowledge of the role genetic variants play in disorders and     possibly how genetic variants may help de-termine the best treatment options.      The recent development of new technologies has increased our ability to understand how     genetic mutations are associated with disease. Using these technologies to find the genetic     variants responsible for rare diseases is a rapidly growing field and has already begun to     transform the way conditions with unknown causes are diagnosed and treated.      Hypothesis: Identification of new genomic variants associated with idiopathic diseases and/or     diseases of unknown etiology will advance medical knowledge about rare and common diseases.   "
140902|NCT01440205|"     The mailer will encourage all employees of one of Evive's partner companies to attend an     on-site free flu shot clinic they are offering in the fall of 2011. The research will examine     differences in follow-through on getting a flu shot at an on-site clinic among the targeted     population during the ~1 month period when clinics are being offered (following the mailing)     as a function of experimental condition.   "
140983|NCT01439152|"     BAY94-9343 is an antibody-drug conjugate (ADC) directed against the cancer antigen mesothelin     on tumor cells. This study will attempt to answer the following questions:        -  What are the side effects of BAY94-9343 when given at different dose levels and          schedules?        -  What dose level and schedule of BAY94-9343 should be tested in future clinical research          studies?        -  How much BAY94-9343 is in the blood at specific times after administration?        -  Does the treatment with BAY94-9343 show any effect on the tumor growth?        -  Are there specific biomarkers that might be able to explain why some patients respond to          treatment and others do not?   "
140906|NCT01440153|"     Professional dancing requires an almost perfect control of technical skills, combined with a     good physical condition. To meet the demands of choreography, dancers need an adequate     aerobic endurance capacity, muscular strength as well as flexibility and motor control     (Twitchett et al. 2009; Roussel et al. 2009). One could compare these requirements to those     of an athlete. In contrasts to athletes, only few attention has been given to the prevention     of injuries in dancers. Professional dancers are at high risk to develop musculoskeletal     injuries, especially, soft tissue and overuse injuries to lower extremities and     spine(Hincapié et al, 2008). Several potential risk factors for injury have been suggested,     such as a reduced level of aerobic fitness, lack of muscular strength, hypermobility of the     joints and altered motor control of the lumbopelvic region but no conclusive evidence exists     for any of these items separately.      Applying sports science principles to dance training may improve the performances of the     dancers (Twitchett et al. 2009). Dancers demonstrate low aerobic fitness and muscle strength,     in contrast to the high demands. Aerobic endurance of dancers is for example comparable to     healthy adults with a sedentary life style.      Fitness programs, additional to regular dance classes, have only recently been considered     (Twitchett et al. 2009). The advantages of additional training in athletes is beyond     questioning. Nevertheless, this concept is relatively new for dancers. On the one hand,     professional dancers do not consider themselves as a sportsmen but as artists (Wyon et al,     2007). On the other hand, choreographers and dancers fear the negative influence of training     on body aesthetics.      Additional fitness training could improve physical fitness & motor control and may help with     stress coping during public performances. Therefore, the purpose of this randomized     controlled trial is to examine whether an additional intervention to regular dance lessons     influences the physical condition and musculoskeletal injury rate in professional dancers.   "
140907|NCT01440140|"     The main study objective is to compare real-time continuous subcutaneous glucose monitoring     (CGM) combined with overnight automated closed-loop glucose control, and real-time CGM alone     in the home setting.   "
140908|NCT01440127|"     Metformin is drug that is normally used to treat people with diabetes. New research has     discovered that metformin may also kill cancer stem cells. These cancer stem cells make up     only a small portion of a cancer, but may be responsible for resistance to chemotherapy or     for causing recurrence of the cancer. The purpose of this study is to determine the effect of     metformin on colorectal cancer tumors. The study is designed to develop the methods to test     tumors for cancer stem cells and then to determine the difference between treating with     metformin and not treating with metformin with regard to the cancer stem cells. This research     is investigational because the effect of metformin on cancer stem cells is not known in     humans. Also, in patients who are not diabetic, metformin would normally not be given prior     to surgery.   "
140909|NCT01440114|"     The propose of this study is to determine the effect of intravenous fentanyl prior the end of     surgery on the incidence and severity of EA in pediatric patient.   "
140910|NCT01440101|"     The primary objective of Part A is to determine the safety and tolerability of natalizumab     administered over 24 weeks in Japanese participants with relapsing-remitting multiple     sclerosis (MS). The endpoints for this will include assessment of adverse evetns (AEs),     changes in laboratory evaluations, vital signs, Expanded Disability Status Scale (EDSS)     scores, and changes in physical and neurological examination findings. The secondary     objectives of Part A are to characterize the pharmacokinetics (PK) profile and     pharmacodynamics (PD) of natalizumab.      The primary objective of Part B is to determine if natalizumab, when compared to placebo, is     effective in treating Japanese participants with relapsing-remitting MS, as measured by new     active lesions on cranial magnetic resonance imaging (MRI) scans over 24 weeks. New active     lesions are the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly-enlarging     T2-hyperintense lesions that do not enhance. The primary endpoint is the rate of development     of new active lesions over 24 weeks.      Secondary objectives of Part B are to determine over 24 weeks whether natalizumab, when     compared to placebo, is effective in reducing the frequency of clinical exacerbations,     reducing the number of Gd+ lesions, reducing the number of new or newly-enlarging     T2-hyperintense lesions on brain MRI scans, increasing the proportion of relapse-free     participants, and improving outcomes on visual analog scale (VAS) assessing the participant's     global impression of his/her well-being. Additional objectives are to assess the safety and     tolerability, the incidence of serum antibodies to natalizumab and the PK profile of     natalizumab.   "
140911|NCT01440088|"     The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is     safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft     Tissue Sarcoma.   "
140912|NCT01440075|"     Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.      It has been reported worldwide, but it is ten times more common in Asian population. The     annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the     second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of     cases between 1 and 5 years, with a maximal incidence around the age of 12 months.      It may results in acquired heart disease in children in developed countries, and may be the     cause of premature coronary artery disease in adulthood.      A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S     population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are     conflicting on this issue and the prevalence of this allel is unknown in North America and     Europe populations.      The clinical picture of KD associate a persistent fever and an antipyretics resistance with     mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is     confirmed by the presence of five clinical signs (major criteria). The presence of     inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.      KD can resolve spontaneously with no treatment. The severity of the disease is primarily     related to complications of coronary aneurysms in acute or chronic stages.      Several arguments support the fact that adult patients have diffuse vascular lesions     different from aneurysmal lesions initially described in childhood.      Despite abundance of publications on KD, there is no prospective or retrospective study which     explored anomalies resulting from KD in adult subjects.      Therefore, this project will describe the patient's vascular evolution, the prevalence of     atherosclerotic lesions and to determine the biological and functional abnormalities, markers     of accelerated atherosclerosis.      Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in     adulthood.      The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and     their severity in adults with a history of KD in childhood compared to a control population.   "
140913|NCT01440062|"     Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple     Sclerosis (MS).   "
140914|NCT01440049|"     On a population of patients followed by an office-based cardiologist and treated with     eplerenone, the objectives of the survey are:        -  To describe the characteristics of the population treated.        -  To describe the methods of use of eplerenone (posology, duration of treatment, medicinal          combinations).        -  To describe the follow-up methods of the treatment.        -  To describe the possible interruptions of the treatment   "
140915|NCT01440036|"     The objective of the research, is to examine the hypothesis, that the enzyme paraoxygenase 1     ( PON1) can influence carotid artery's atherosclerotic plaque content and stability, and its     relation to plasma's enzyme concentration.   "
140946|NCT01439633|"     The specific aim of this study is to determine the feasibility of marking target pathologic     locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial     cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of     biopsy.   "
140918|NCT01439997|"     The objective of this study is to find out what the pharmacodynamic (PD) characteristics of     desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The     main questions the investigators want to answer are:        -  Are differences related to the pathophysiological factors involved in nocturia?        -  Are there age/gender/size differences?        -  Can the investigators identify patients who are likely to develop hyponatraemia?        -  Can the investigators individualize treatment and reduce risk for hyponatraemia?      The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy.     During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.      There are two groups of patients:      Group A:      Patients that still have to undergo an evaluation phase, according to standard procedures     (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study     starts when the 1st Minirin Melt tablet has been taken (= day 1).      Group B:      This group already went through the evaluation phase (by participation to study 1 or study 3     as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.      The study starts when the patients takes his first prescribed Minirin Melt tablet:        -  On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+,          K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day          3 and day 7) are standard procedure. If the patient is at high risk for side effects,          blood has to be taken during the first 7 days.        -  On day 3 the patient has to give a urine sample.        -  Patients have to fill out a frequency/volume chart during the first 14 days.        -  On day 30, a 3rd blood sample will be taken   "
140919|NCT01439984|"     The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the     treatment of premature ejaculation.   "
140920|NCT01439971|"     This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe     to administer to subjects with severe Hemophilia A or B with or without inhibitors and will     demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in     hemophilic animal models.   "
140921|NCT01439958|"     The purpose of this study is to evaluate long-term safety of L-CsA in prevention of     bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients     previously enrolled in phase II/III L-CsA clinical trial 12011.201.   "
140922|NCT01439945|"     RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of     breast cancer.      PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of     magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a     history of breast cancer.   "
140923|NCT01439932|"     Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the     population during life. This is a degenerative condition of the plantar fascia at its     insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning or     after prolonged lack of weight bearing. The pain intensity can be very high and this can     cause functional limitations and reduce quality of life.      Despite the high prevalence of the PF, treatment is controversial and not supported by     extensive research. Review of the previous studies on various treatments, mentioned steroid     injections, shock waves, night splint, orthotics, heel padding and stretching exercises.      Limitation of ankle dorsi flexion is a common finding and thought to be a contributing factor     to the development of pathology. So far, this issue had been addressed mainly by soft tissue     therapy techniques to improve ankle range of motion in patients with PF. Only one study     (Joshua et al 2009) evaluated the effect of ankle joint mobilizations of PF. However, in this     study mobilizations were part of complex therapy and therefore the effect of treatment cannot     be attributed solely to them.      The purpose of this study is to evaluate the effectiveness of ankle and mid-foot joints     mobilization on pain and function of patients with PF.      The hypothesis is that manual mobilizations of ankle and midfoot joints in addition to     conventional physical therapy will improve pain and function significantly more than     conventional treatment, in patients with PF.      Methods: 50 patients, age 18-75 with a diagnosis of PF that meet the inclusion criteria will     be recruited and randomly divided into two groups. Both groups will receive commonly accepted     physical therapy treatment that includes stretching exercise of the plantar fascia and     triceps surae muscles and ultrasound therapy at the site of symptoms. The study group will     receive in addition manual mobilizations to the ankle and midfoot joints. The procedures will     take place at the physiotherapy clinic Bat-Yamon of General Health Services and will last     four weeks, twice a week.   "
140924|NCT01439919|"     The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily     compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric     Rating Scale (NRS).      Secondary Objectives are:        -  To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency,          background therapy utilization, mood, patient satisfaction of pain relief, nausea,          constipation, healthcare utilization and quality of life;        -  To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for          persistent cancer pain;        -  To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and          cancer pain treatment;        -  To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for          persistent cancer pain;        -  To assess endocannabinoid plasma concentrations.   "
140925|NCT01439906|"     The study aims to analyze the surgical treatment of low back pain due to degenerative     kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico     Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of back     pain and functional ability before and after the surgical treatment will be performed by     administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry     Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be     matched to a purely objective and radiological assessment according to international     guidelines. A psychological analysis will be also performed in order to evaluate co-morbidity     from this field, considering that the concept of shared decision-making for the therapeutic     approach to low back pain requires the evaluation of all these parameters.   "
140926|NCT01439893|"     This is a multi-center, randomized, double-blind , placebo parallel controlled, standard     therapy based phase III clinical trial, to evaluate the efficacy of recombinant human     neuregulin-1 on cardiac remodeling, as well as safety in patients with chronic heart failure.   "
140927|NCT01439880|"     The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be     safe and well tolerated in subjects with hypercholesterolemia.   "
140928|NCT01439867|"     The primary objective was to characterize corrected serum calcium levels on treatment with     cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).   "
140929|NCT01439854|"     The purpose of this study is to examine the effect of the chronic treatment of type 2     diabetes (T2DM) with dapagliflozin on: (1) mitochondrial gene function/expression and insulin     signaling/action and (2) oral glucose tolerance and beta cell function. Dapagliflozin is a     potent, highly specific inhibitor of renal glucose transport [SGLT2].   "
140930|NCT01439841|"     HIV progression is closely associated with chronic immune activation driven by leakage of     bacterial products from a damaged gut, the investigators largest immunological organ.     Notably, the degree of immune activation has been suggested to be a better predictor of     disease progression than plasma viral load, and markers of immune activation and gut damage     have been identified as therapeutic targets per se. The major damage by HIV to the immune     system is an initial massacre of gut mucosal CD4+ Th17 cells. Interestingly, a normal gut     flora has been shown to induce the maturation of Th17 cells in the small intestine mucosa.     Preliminary reports have shown that the gut flora is altered in HIV-1 infection compared to     controls. In this project, the investigators will characterize microbial composition of gut     flora in chronic HIV infection with ultradeep sequencing. Gut flora composition will be     related to clinical data as well as quantitative data of circulating microbial products and     activation markers. Second, in a randomized clinical trial (RCT) the effect of probiotic     lactobacilli on HIV pathogenesis and progression will be tested. This Gram-positive strain is     clinically tested and is able to colonize the gut.   "
140931|NCT01439828|"     The primary purpose is to assess the efficacy in human of N-acetylcysteine versus placebo     during 4 weeks in cannabis withdrawal.   "
140932|NCT01439815|"     The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal     spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following     ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.   "
140933|NCT01439802|"     The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices     (IUDs) placed at time of Cesarean Delivery.   "
140934|NCT01439789|"     Multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based     phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on serum     NT-proBNP, as well as safety in patients with chronic heart failure.   "
140935|NCT01439776|"     Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy     obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3     Studies rarely address the issues of improving host factors. The current study examines     whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral     response(SVR)compared to Peg/RBV.   "
140936|NCT01439763|"     The specific aims of this study are:        -  To determine the prevalence of bullying in children who present to the ED with          behavioral symptoms        -  To assess mental health diagnoses and their relationship to type, severity and frequency          of bullying behaviors, as well as demographic and psychosocial correlates (socioeconomic          status, stress and support) and their relationship to type, severity and frequency of          bullying (bullies versus victims).        -  To explore the attitudes, values, triggering events and potential solutions using          qualitative methods        -  To gain greater insight into the patient experience and perceptions of the bullying          events   "
140937|NCT01439750|"     This is a phase I/II trial of bortezomib, cladribine, and rituximab in newly diagnosed and     relapsed mantle cell lymphoma (MCL). The phase I component has three dose levels of     cladribine (3 mg/m2, 4 mg/m2, and 5 mg/m2) and is designed as a traditional dose-escalation     study in which cohorts of 3 patients are evaluated for the incidence of dose-liming toxicity     (DLT) at each dose level. Once the maximum tolerated dose (MTD) is determined, a phase II     component with 2 arms will begin. One arm will enroll newly diagnosed MCL patients and one     arm will enroll relapsed MCL patients. Each arm is a single-stage, fixed sample size study     and will be accrued and analyzed separately. The phase I and II data will also be analyzed     separately.   "
140938|NCT01439737|"     Asthma is a chronic inflammatory airway disease. Significant heterogeneity exists in the     clinical manifestations and treatment responses in these patients. Metabolomics is a     large-scale approach to monitoring as many as possible of the compounds involved in cellular     processes in a single assay to derive metabolic profiles. Compared with genomics or     proteomics, metabolomics reflects changes in phenotype and therefore function. Up to now, few     studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic     evaluation of airway disorders. Collection of exhaled breath condensate (EBC) is a newly     developed, noninvasive method that may allow clinicians and researchers to assess biochemical     profiles in the alveolar lining fluid. This study will apply metabolomics to examine the     biomarkers in the EBCs, serum and urine specimens in adult asthmatics.   "
140939|NCT01439724|"     Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas     patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level     laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This     study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the     incidence and/or severity of oral mucositis.   "
140940|NCT01439711|"     RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using     letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by     lowering the amount of estrogen the body makes.      PURPOSE: This phase II trial is studying how well letrozole works in treating women with     ductal carcinoma in situ.   "
140941|NCT01439698|"     The objective of this protocol is to establish a multicenter registry to evaluate the impact     of radiofrequency ablation in the management of patients with pancreatico-biliary disorders     including malignancies.   "
140942|NCT01439685|"     This study entails retrospective and prospective review of data from a database protocol.     Data gathered will be then analyzed for a set amount of patients. In this study, the     investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy     (PDT) and assess if PDT can improve quality of life and prolong survival.   "
140943|NCT01439672|"     This protocol will investigate physiological parameters including insulin sensitivity and     counterregulatory function using a mixed meal test and induced hypoglycemia in subjects with     type I diabetes.   "
140944|NCT01439659|"     The goal of this clinical research study is to see if ovarian cancer patients who add Juice     PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian     cancer patients who receive only dietary counseling alone.   "
140947|NCT01439620|"     The goal of this study is to evaluate the potential of comprehensive biliary Optical     Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct     strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing     cholangitis (PSC).   "
140954|NCT01439529|"     New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated,     such as the use of the electrocardiogram.      In this prospective, double-blind, study, the investigators will evaluate:      Primary endpoint: To compare the clinical response to CRT in patients with the programming     optimized by QRS versus the nominal suggested by the device.      Secondary endpoints:        1. To compare cardiac remodeling in patients with the programming optimized by QRS versus          the nominal suggested by the device.        2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS)          with respect to the intrinsic rhythm.        3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both          groups.        4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial          sensing or atrial pacing.      For that, 180 patients with an indication for CRT will be randomized to nominal programming     of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and     echocardiographic evaluation will be done at baseline, 6 and 12 months.   "
140955|NCT01439516|"     African Americans are less likely than Whites to receive kidney transplants, despite their     being more than two-fold as likely as Whites to develop end stage renal disease (ESRD).     Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to     receipt of deceased kidney transplants (e.g. waiting lists and immunological     incompatibility), but minorities are less likely to receive living related kidney transplants     (LRT). Evidence suggests African Americans may not discuss LD/LRT with their families or     physicians at optimal rates, and thus may not have adequate information to initiate or     participate in shared decision-making regarding LD/LRT. African Americans may also have     financial concerns regarding convalescence and out of pocket expenses related to LD/LRT,     another barrier impeding LD/LRT.      The primary goals of this study are to overcome these important barriers by enhancing ethnic     minorities' consideration of LD/LRT through the promotion of shared decision-making regarding     LD/LRT and provision of financial assistance for out of pocket expenses. The investigators     specific aims are: a) to develop culturally sensitive informational (audiovisual) and     financial interventions and b) to perform a randomized controlled trial to assess their     effectiveness in increasing pursuit of LD/LRT among African American patients with ESRD and     their families. The investigators hypothesize: (1) Patients and families who view     informational materials designed to promote shared decision-making regarding LD/LRT will be     more likely than patients and families not viewing these materials to discuss LD/LRT with     family and with health care professionals. Patients and families viewing such informational     materials will also be more likely than those not viewing these materials to pursue and     complete the LD/LRT process and (2) patients and their families who are offered the     intervention to promote shared decision-making plus a financial assistance intervention for     potential live kidney donors will be more likely than patients and families not offered both     interventions to pursue and complete the LD/LRT process.   "
140956|NCT01439503|"     To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620     eligible African American men who have sex with men (MSM) will be conducted. Men in the     treatment condition will be compared to men receiving the control condition comprised of     standard of care counseling from the clinic plus a free bag of condoms and water-based     lubricants. This two-arm trial will test four hypotheses:      Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed     to reduce STD incidence and risk of HIV acquisition/transmission among young African American     men (15-29 years old) having sex with men and presenting for STD testing.      H1. Men randomized to receive the intervention will have a lower incidence rate of     laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving     the control condition.      H2. Men randomized to receive the intervention will report significantly fewer acts of     unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments     compared to those receiving the control condition.      H3. Men randomized to receive the intervention will report having significantly fewer     unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between     follow-up assessments compared to those receiving the control condition.      H4. Men randomized to receive the intervention will report having significantly fewer     negative experiences with condom use between follow-up assessments compared to those     receiving the control condition.      H5. Men randomized to receive the intervention will demonstrate significantly greater     improvement in condom application skills, throughout the 12-month study, compared to those     receiving the control condition.   "
140957|NCT01439490|"     Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER)     alpha and beta are present in 20-100% of ovarian cancer patients. For this reason,     antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive     treatment option. However, only a small proportion of patients (5-19%) will respond to     antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron     emission tomography (PET) with [18F]fluoroestradiol (FES). In this study the investigators     will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian     cancer. If these results are positive, this would warrant further exploration of FES-PET     imaging in ovarian cancer.   "
140958|NCT01439477|"     Cardiovascular disease (CVD) is the leading cause of death for women in the United States.     CVD disproportionately affects underserved populations, specifically low-income, minority,     and rural women who have higher obesity rates and experience other health disparities. There     is a need for replicable, evidence-based programs that target women, particularly midlife and     older women who represent an increasing proportion of the U.S. population, to reduce their     CVD risk . StrongWomen - Healthy Hearts is a 12-week, community-based program that has     demonstrated effectiveness at improving CVD risk factors, including body weight, diet     quality, and physical activity in a controlled, randomized trial conducted with midlife and     older overweight and obese subjects in Arkansas and Kansas.      The central objective is to rigorously evaluate dissemination of the StrongWomen - Healthy     Hearts Program using the RE-AIM framework to achieve maximal public health impact. Expanded     dissemination will occur through the Cooperative State Research, Education and Extension     Service (CSREES) This partnership will leverage a long and successful collaboration between     Tufts University and CSREES that provides strength training programs to older women in 41     states.   "
140959|NCT01439464|"     The goal of this study is to compare Bonglass-SS with titanum cage.   "
140960|NCT01439451|"     The proposed project is a prospective experimental Randomized Control Trial study design.     Independent old adults (age 70 years old and older) who do not suffer from balance problems     willing to participate in the study will be tested before and after Peturbation balance     training during walking to explore whether there are differences in balance control and     balance reactions as a result of training.   "
140961|NCT01439438|"     This study is prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods. The volunteers received, in each period, the     reference or the test formulation, according to the randomization list, under fasting     conditions, in order to evaluate if the reference and test formulations are bioequivalent.   "
140984|NCT01439139|"     The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus     densitometry (DXA) in osteoporosis detection.   "
140962|NCT01439425|"     The relative risk of psoriasis and its severity are directly related to the body mass index     (BMI).Patients with psoriasis likely undergo a vicious circle where obesity and skin disease     reinforce each other. To investigate patients' opinion about their body weight (BW), the     possibility of dietary approach to psoriasis, and to examine the adherence and the effects of     hypo-energetic diet to maintain disease remission in obese patients a dedicated questionnaire     was administered to 200 consecutive patients (125 men and 75 women) with moderate-to-severe     chronic plaque psoriasis investigating whether diet factors could influence psoriasis     severity and course. In second part of study, obese patients with psoriasis in remission     (PASI improvement ≥ 75%) for at least 12 weeks after methotrexate therapy were randomly     assigned to receive a hypo-caloric diet or free diet for 24 weeks, and then followed up for     additional 12 weeks.   "
140963|NCT01439412|"     Acute low back pain is a common disorder in general practice. Some general practitioners     (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its     effectiveness for this condition.      The aim of this study is to evaluate whether a single treatment-session with acupuncture can     reduce time to recovery when applied in addition to standard LBP-treatment according to the     Norwegian national guidelines. Analyses of prognostic factors for recovery and     cost-effectiveness will also be carried out.      The investigators hypotheses are:        1. Acupuncture treatment contributes to faster pain-recovery in acute LBP compared to          standard treatment in general practice provided in accordance with the Norwegian          national guidelines.        2. Acupuncture treatment for acute LBP improves function, and reduces drug use and sick          leave, compared to the standard treatment in general practice provided in accordance          with national guidelines.        3. Acupuncture treatment for acute LBP is a cost-effective treatment in general practice.      The investigators intend to include a total of 270 patients, 135 in the intervention group     and 135 in the control group.      The investigators planned to do an interim analysis when reaching inclusion of 150 patients.     However, this might lead to reduced overall significance level, and as a result of slow     inclusion rate (by December 2015), the investigators plan to extend the inclusion time with     one year and then complete the study in March 2017.   "
140964|NCT01439399|"     The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine     and ketamine in the perioperative period of abdominal surgery.   "
140965|NCT01439386|"     This prospective, multi-center, single blinded study aims to compare the influence of two     different catheter ablation strategies, on long-term ablation outcome in terms of AF     recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The     two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF)     with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.   "
140966|NCT01439373|"     GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of     chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and     pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and     ribavirin in subjects with chronic hepatitis C (CHC).   "
140967|NCT01439360|"     The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK     Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine     comparators in children 6 to 35 months of age. Recruitment will encompass at least 4     independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort     in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a     fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and     subtropical countries (beginning 2014).   "
140968|NCT01439347|"     A phase 3 study in the treatment of subjects >or= 60 years old with newly diagnosed acute     lymphoblastic leukemia (ALL).   "
140969|NCT01439334|"     The primary purpose of this research is to develop and evaluate the short-term efficacy of an     innovative multiple behavior screening, brief intervention and referral to treatment     (MB-SBIRT) model using social images and future self-images to simultaneously link and reduce     prescription and other co-occurring drug use behaviors among emerging adults in a primary     care setting serving a racially and economically diverse community. The long term objective     of this research is to cost-effectively reduce prescription and illicit drug abuse, along     with alcohol and tobacco consumption, and improve health-related quality of life among     high-risk emerging adults often ignored in intervention research and services.   "
140982|NCT01439165|"     The purpose of this study is to describe the safety and immunogenicity of repeat     administration of Adacel vaccine approximately 10 years following initial administration of     the vaccine. Antibody levels prior to revaccination will also be used to characterize     antibody persistence following initial vaccination 10 years earlier.      Primary Objectives:        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine          to those induced by Td Adsorbed vaccine.        -  To compare booster response rates against tetanus and diphtheria induced by Adacel          vaccine to those induced by Td Adsorbed vaccine.        -  To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by          Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants.      Secondary Objectives:        -  To describe the rates of immediate reactions, solicited reactions, unsolicited adverse          events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td          Adsorbed vaccine.        -  To describe booster response rates for pertussis antigens following revaccination with          Adacel vaccine.   "
141205|NCT01436240|"     The purpose of this study is to see if questions in English about symptoms that patients may     have during cancer treatment are understandable when translated into Spanish. These questions     will later be used in future studies to give a better understanding of patient symptoms.   "
140985|NCT01439126|"     The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™     (clonidine hydrochloride) extended-release in children and adolescents with Attention Deficit     Hyperactivity Disorder (ADHD)   "
141003|NCT01438892|"     Several observational studies have evaluated the comparative treatment costs associated with     each agent, particularly those within the anti-TNF class, but few have evaluated the impact     of therapy compliance, persistence, treatment patterns on patient reported outcomes,     healthcare utilization and costs, using a provider database. This study is designed to fill     in this information gap.   "
140970|NCT01439321|"     Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and the     risk of severe bleeding complications. The two recently introduced TPO-RA drugs, namely,     eltrombopag and romiplostim, have shown efficacious sustained response with continuous     administration. Both drugs are indicated for the treatment of thrombocytopia in patients with     chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or     splenectomy. While these trials address important clinical questions they were not intended     to evaluate what happens in the real-world settings with actual patient living daily lives.     The purpose of this health outcomes study is to understand how the two TPO receptor agonists     (TPO-RA) currently available in the US are being used in clinical practice and how their use     impacts chronic ITP patients' daily lives. The study hypothesis is that patients who switched     to eltrombopag report a better health-related quality of life than those who switched to     romiplostim. This study utilized a hybrid design of retrospective chart review study and     cross-sectional patient survey. A customized Patient Case Report Form (CRF) will be used to     retrospectively collect clinical data from patient medical charts where the primary cohorts     consist of patients who have switched from other ITP medication to eltrombopag or     romiplostim. A cross-sectional survey will be employed to collect patient reported outcomes     (PRO) data, including health-related quality of life and treatment satisfaction, using a     compository questionnaire. Analyses of cross-sectional survey data and retrospective medical     chart review data in patients who switch to either eltrombopag or romiplostim from their     prior primary therapy will be conducted.   "
140971|NCT01439308|"     This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by     capsaicin challenge   "
140972|NCT01439295|"     Urinary ascorbyl peroxide level in the first week of life will be a good predictor of     Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.   "
140973|NCT01439282|"     This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in     combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65     subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal,     estrogen receptor (ER)-positive breast cancer.   "
140974|NCT01439269|"     The purpose of this study is to test the efficacy of a family nurture intervention in the     neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family     nurture are compared to infants receiving standard NICU care. The intervention enhances     mother/infant interactions that are vital to early development in the infant. The main goal     is to get the mother and infant into biological synchrony, emotional attunement and mutual     calm through an activity referred to as a calming cycle. Mother's are encouraged to engage     in the calming cycle activities as much as possible. Her increased effectiveness in calming     her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions     about having delivered a baby prematurely, and help her gain confidence in her care-taking     abilities, which in other studies predicted shorter length of stay and fewer     re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle     activities providing appropriate types of stimulation for their babies that are important for     social, emotional, and neurobehavioral development. Since preterm babies are often easily     upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU     and in follow-up visits for two years will test the immediate and long-term effects of this     new approach to the nurture of prematurely born infants.   "
140975|NCT01439256|"     This study focuses on an important patient behavior, medication-taking, and important     physician behaviors: promoting medication regimen adherence in patients and appropriately     modifying therapy when existing therapy results in inadequate therapeutic effect. The study     will also explore the caregivers' (clinicians) behavior after relevant information about     their patients' medication adherence and blood pressure control has been provided to them.     The investigators focus on behavior change for patients and physicians and seek to change     their behaviors to improve the health care delivery process and outcomes. The study aims at     facilitating tertiary prevention of cardiovascular, cerebrovascular, and reno-vascular     diseases by promoting better blood pressure control.   "
140976|NCT01439243|"     The objective of this study was to compare the rate and extent of absorption of donepezil 10     mg tablet (test) versus Aricept® (reference), administered as 1 x 10 mg tablet under fed     conditions.   "
140977|NCT01439230|"     The objective of this study was to compare the rate and extent of absorption of donepezil 10     mg tablet (test) versus Aricept® (reference), administered as a 1 x 10 mg tablet under     fasting conditions.   "
140978|NCT01439217|"     Specific Aim: Compare the endothelial function, arterial stiffness and components of     metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy     sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls     including measures of endothelial function and arterial stiffness obtained form a peripheral     artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and     insulin.   "
140979|NCT01439204|"     The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667)     drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers     Squibb are comparable in healthy subjects   "
140980|NCT01439191|"     The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human     breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a     humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment     for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has     been shown to increase both survival and response rate, in comparison to trastuzumab alone.     CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical     Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine     were evaluated in patients with HER2-overexpressing metastatic breast cancer.   "
140981|NCT01439178|"     Purpose: To evaluate the acute changes in intraocular cytokines after intravitreal     bevacizumab (IVB) in proliferative diabetic retinopathy.      Design: Prospective, open-label, controlled, randomized interventional clinical trial.      Participants: Twenty eyes of 28 consecutive patients who are scheduled for pars plana     vitrectomy (ppV) for proliferative diabetic retinopathy were prospectively enrolled.      Methods: All patients were randomly assigned to receive IVB either at 2 or 7 days before ppV.     Aqueous humor samples were taken from anterior chamber just before IVB and at the time of     surgery. Multiplex cytokine array were used to assay various cytokines   "
140986|NCT01439113|"     The placement of peripheral intravenous lines (IVs) is central to the treatment of patients     in the emergency department (ED). The procedure is used for phlebotomy and administration of     a variety of therapeutic medications and intravenous fluids. This procedure is standard of     care, and IVs are routinely placed by experienced emergency nurses.      Occasionally, the nurse will have difficulty placing an IV line. The most common reason for     this is an underlying medical condition, such as diabetes, severe peripheral vascular     disease, obesity, or a history of intravenous drug use. When a nurse is unable to place an     IV, the options are:        1. Ask another nurse to attempt the line placement        2. Ask a physician to establish access, which usually involves placement of a central          venous catheter, a time-consuming procedure with higher risk of infection than a          peripheral line.      The use of bedside ultrasound has become commonplace in the modern ED, and the Tufts Medical     Center ED possesses its own machine, which is used for a variety of indications including     diagnosis of pregnancy, gall bladder disease, abdominal free fluid or pericardial effusion.     Another key use of bedside ultrasound is the location of blood vessels. In fact, it is now     expected that when placing a central venous catheter the clinician use ultrasound guidance,     as the ultrasound clearly demonstrates blood vessels. The procedure is completely pain-free     and harmless, and costs nothing to perform.      Recently, there has been a growing body of evidence demonstrating that placement of     peripheral IVs can be facilitated by the use of ultrasound. Just as it is useful for central     venous catheters, ultrasound can also clearly show smaller peripheral veins. Multiple studies     have demonstrated that physicians can place IVs with ultrasound guidance.      However, nurses are the de facto experts at placing peripheral IVs as it is a usual procedure     for them to perform and they perform the procedure multiple times a day. In this study, we     will provide a two-hour training program to a cohort of nurses. The training program will     instruct them in the use of single-operator ultrasound-guided IV placement. After training,     once the nurse encounters a patient with difficult IV access (either 2 failed attempts or     history of difficult access), the patient will be consented and randomized to either the     standard of care (whatever the nurse elects to do) or use of the bedside ultrasound.      In the meantime, the research assistant will measure time to IV placement starting from     enrollment, the number of skin punctures that are necessary to place the IV, and then ask the     patient questions about satisfaction with the IV placement and the pain they experienced.      Our hypothesis is that single-operator, ED nurse use of bedside ultrasound will facilitate IV     placement in patients with difficult IV access, saving time and also improving patient     satisfaction and comfort.   "
140987|NCT01439100|"     To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy     in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by     averaged 24 hour pain scores collected for 7 days prior to the clinic visits   "
140988|NCT01439087|"     The goal of this research is to conduct a pilot clinical study to image colonic polyps with     the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to     identify the extent of invasion (if present), differentiate between hyperplastic polyps and     adenomas, and identify serrated polyps.   "
140989|NCT01439074|"     The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag)     compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn     injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be     up to 4 weeks with either Mepilex Ag or SSD.   "
140990|NCT01439061|"     This is an Italian, Multicentre, Observational Study to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
140991|NCT01439048|"     The purpose of this study is to determine if changes in specific gene products in the     placenta or cord/infant blood affect a baby's birth weight, increase the risk of premature     birth, or increase the risk of developing diseases of prematurity. We would also like to     characterize whether placental epigenetic changes or placental markers of environmental     exposures are associated with premature birth.   "
140992|NCT01439035|"     The goal of this research is to conduct a pilot clinical study to image Celiac disease     characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to     histologic evaluation in children, adolescents and young adults with suspected Celiac     disease.   "
140993|NCT01439022|"     This study sets out to determine the effect of exercise performed over a longer period of     time (6 months), delivered using community facilities, on motor and non motor symptoms,     health and well being in people with Parkinson's Disease.   "
140994|NCT01439009|"     One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the     morning for up to 14 days to heart failure patients with volume overload that does not show     adequate response to other diuretics such as loop diuretics in order to investigate the     effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy     of tolvaptan during the treatment period will also be investigated.   "
140995|NCT01438996|"     The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi     antibody response following secondary vaccination with the Novartis Vaccines Institute for     Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either     the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and     the immunogenicity and the kinetics of the anti-Vi antibody response following primary     vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.   "
140996|NCT01438983|"     This is an observational, non-randomised trial to evaluate the effect of dietary type on     infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45     breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular     pediatric appointment. Infants with unremarkable health histories, normal weight, free of     sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also healthy     and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of     antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and     mammary candidiasis in mothers were exclusion criteria.   "
141044|NCT01438359|"     The purpose of this study is to determine if Furosemide is affected by PA21.   "
141275|NCT01435330|"     The study will assess the safety, tolerability, drug label and effect in subjects with and     without insulin resistance.   "
140997|NCT01438970|"     This is a single centre, prospective, uncontrolled study to include 12 consecutive patients     with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary     objective) of the study is to investigate the effect of treatment of ascites by the Sequana     medical pump on the renal and circulatory function in patients with cirrhosis and recurrent     or refractory ascites. The secondary objectives are the following:        -  To evaluate the efficacy of treatment for handling ascites, associated with changes in          the body weight of patients and their requirements for evacuation paracentesis during          follow-up.        -  To investigate the effects of treatment on bacterial translocation, by means of          determining bacterial DNA.        -  To determine the incidence of complications associated with treatment in the course of          follow-up.        -  To evaluate the effect of treatment on quality of life of the patients treated,          evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease          questionnaire).   "
141004|NCT01438879|"     Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central     nervous system infections.      Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system     (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF)     polymerase chain reaction (PCR)-result for the virus.      The aim of this study is to evaluate the presence of DNA from lymphocytic herpesviruses in     the CSF obtained from the immunocompetent patients with CSF pleocytosis and from the patients     with normal CSF leukocyte count.   "
141005|NCT01438866|"     Sealants have been shown to be the most effective caries preventive measure in permanent     dentition. Sealants of the primary molars soon after they erupt would reduce the total caries     experience of the primary teeth of the children and could possibly also postpone the caries     process in the permanent dentition.      The aim of this study is to measure the caries preventive effect of sealants in primary     molars. The specific objectives are: 1) to compare the number of new caries experience teeth     and surfaces among the intervention group of 4-years old pre-school children during the 1     year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish     on the caries experience on the occlusal surfaces of the primary molars and on the total     caries experience of all the primary and permanent teeth, 3) to test the feasibility of the     sealant program in one kindergarten in Kuwait city.   "
141006|NCT01438853|"     This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded     dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in     subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least     six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to     receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15     minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics     of the study treatment were evaluated.   "
141007|NCT01438840|"     Core Study:      To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is     superior to placebo (in addition to standard of care) for the treatment of adult participants     with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured     by cumulative number of weeks of platelet response over 6 months of once daily treatment in     adults participants who received at least 1 prior ITP therapy.      Extension Phase:      To evaluate the safety and tolerability of long-term therapy with avatrombopag in     participants with chronic ITP (cITP).   "
141008|NCT01438827|"     The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+     (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen     induced allergic rhinoconjunctivitis with or without asthma.   "
141009|NCT01438814|"     The aim of this study is to investigate the impact of the combination therapy of linagliptin     and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and     metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of     with type 2 diabetes mellitus.   "
141010|NCT01438801|"     The evaluation of a standardized diagnostic test to predict the growth response in a 1 year     trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care)     in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).   "
141045|NCT01438346|"     This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB)     for reducing substance abuse problems in women who are undergoing a substance abuse treatment     program. The main hypothesis is that MBB will be more effective than the control (standard)     intervention program in helping people reduce their craving for illicit substances and/or     alcohol.   "
141011|NCT01438788|"     -  This is a 2 stage exploratory study with a 3-month observational phase on the natural          course, followed by a 12-month, open-label, non-comparative, single-arm, phase II pilot          study on the efficacy, safety and tolerability of a low-protein diet (LPD) in 8 adult          patients with Bethlem myopathy (BM) and Ullrich congenital muscular dystrophy (UCMD).        -  Objective of this trial is to test the effect of a normocaloric LPD to reactivate          autophagy in BM/UCMD patients. The primary end point of the study will be the change in          muscle biopsy of Beclin 1, a marker of autophagy, at 1 year of LPD treatment when          compared to baseline.        -  The rationale rests on our discoveries that (i) mitochondrial dysfunction mediated by          inappropriate opening of the PTP plays a key role in collagen VI myopathies; (ii)          defective autophagy with impaired removal of defective mitochondria amplifies the          defect; and (iii) reactivation of autophagy with a low-protein diet or treatment with          cyclosporine A, the mitochondrial PTP inhibitor, cured Co6a1-/- mice, hinting at a          common target among all beneficial treatments - namely autophagy.        -  Specific aims of this project are to (i) study the modifications of clinical,          nutritional and laboratory parameters in a cohort of patients with BM/UCMD during a          3-month observational period before starting the LPD treatment; (ii) assess the effect          of a normocaloric LPD in correcting defective autophagy in muscle of patients; (iii)          test if new non-invasive biomarkers of activation of autophagy examined in the blood are          mirroring the effect of LPD in the muscle biopsy; (iv) assess the clinical efficacy and          safety of the LPD with an innovative combination of complementary measures of the          nutritional status in patients.        -  The anticipated output is defining and validating a therapeutic nutritional approach in          autophagy upregulation for BM/UCMD.   "
141012|NCT01438775|"     This study is designed to demonstrate the safety and efficacy of a second transrectal     intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH)     who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.   "
141013|NCT01438762|"     Self-reported, unspecific knee pain is highly prevalent among adolescents. A large proportion     of the unspecific knee pain can be attributed to Patellofemoral Pain Syndrome (PFPS). There     are a number of treatment options for PFPS. Physical therapy has been advocated as one of the     cornerstones in rehabilitation of patients with PFPS. Twenty-five years ago, McConnell     proposed a multimodal approach that combined several treatment options. The regimen included     retraining of the vastus medialis oblique muscle through functional weight bearing     activities. This exercise is combined with patellar taping, patellar mobilization, and     stretching to improve patellar tracking, reduce pain, and enhance vastus medialis oblique     muscle activation. Short term results (<12 months) indicates that multimodal physiotherapy is     more effective than placebo treatment.      While treatment for PFPS may be successful for the short-term, long-term results are less     promising. A recent review covering the long term prognosis for patients diagnosed with PFPS,     reported that only 1/3 of those diagnosed with PFPS and treated conservatively were pain free     12 months after diagnosis. Further ¼ stopped participating in sports because of knee pain.      Predictors of long term outcome (>52weeks) indicate that a long symptom duration, higher age     and greater severity at baseline are associated to poorer outcome after treatment. These     prognostic factors suggest that an early initiation of treatment might lead to a better     long-term prognosis. The purpose of this study is to examine the short and long-term     effectiveness of multi-modal physiotherapy compared to standard wait-and-see treatment     applied at a very early state of disease among adolescents. The investigators hypothesized a     significantly larger proportion of completely recovered patients at three-month follow-up in     the interventions group compared to the control group.   "
141576|NCT01431365|"     Smokers will complete questionnaires and smoking behaviour will be examined. After abstaining     from smoking for approximately 18 hours, they will be randomized to a moderate intensity     exercise group or passive sitting group. Smoking behaviour (time to first puff) will be     assessed following treatment.   "
141014|NCT01438749|"     This randomized, placebo- and active-controlled, crossover study will evaluate the abuse     liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1),     subjects will receive a single dose of either diazepam or placebo in an inpatient crossover     design, with a wash-out period of at least 10 days between treatments. Subjects who are     clearly able to distinguish the positive control from placebo will be enrolled in the main     study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels),     diazepam and placebo in a double-blind, double-dummy inpatient crossover design.     Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.   "
141015|NCT01438736|"     The purpose of the study is to examine how well three months preceding use of Cerazette     progestin only pill predicts the bleeding pattern during following Nexplanon implant use.   "
141016|NCT01438723|"     Rationale:      In patients with a myocardial infarction, occlusion of a coronary artery induces myocardial     ischemia and cell death. If untreated, the area of myocardium exposed to this interruption in     blood supply, will largely become necrotic. The only way to limit final infarct size, is     timely reperfusion of the occluded artery. Paradoxically, however, reperfusion itself can     also damage myocardial tissue and contribute to the final infarct size (reperfusion     injury). Also during coronary artery bypass grafting (CABG), the myocardium is exposed to     ischemia and reperfusion, which will induce cell death. Indeed, postoperatively, the plasma     concentration of troponin I, a marker of cardiac necrosis, is increased, and associated with     adverse outcome. The anti-hyperglycaemic drug metformin has been shown in preclinical studies     to be able to reduce ischemia-reperfusion injury and to limit myocardial infarct size.     Moreover, metformin therapy improves cardiovascular prognosis in patients with diabetes     mellitus. Paradoxically, in patients with diabetes, current practice is to temporarily stop     metformin before major surgery for the presumed risk of lactic acidosis, which is a rare     complication of metformin. However, here is no evidence that this practice benefits the     patient. The investigators hypothesize that pretreatment with metformin can reduce myocardial     injury in patients undergoing elective CABG surgery   "
141017|NCT01438710|"     This study will evaluate and measure symptomatic hand tremor in stable kidney transplant     subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion)     and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro     compared with Prograf or generic tacrolimus   "
141018|NCT01438697|"     This study will compare the efficacy of an interactive Internet intervention for adult     insomnia (Sleep Healthy Using the Internet; SHUTi) to that of a static educational website to     improve sleep, mood related symptoms, perceived health status, and overall quality of life.   "
141019|NCT01438684|"     The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state     patients. The assessment will be done using clinical measurements and functional MRI studies.   "
141020|NCT01438671|"     Our hypothesis is the investigators will find a significant advantage for the use of a     virtual reality system like the Wii Fit to improve overall balance scores versus the use of     traditional balance activities alone. The objectives will be to determine the enjoyment of     these types of gaming activities through the use of a survey to support the hypothesis that     these activities are more enjoyable than traditional activities and to gather evidence to     support the use of these more enjoyable activities as a viable and needed addition to the     overall balance regimen given in the plan of care for a patient with traumatic or acquired     brain injury, stroke or spinal cord injury.   "
141046|NCT01438333|"     The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis     CD2 tablets in addition to the primary treatment for patients with chronic periodontitis     (Full Mouth Disinfection), at local level and at systemic level.   "
141047|NCT01438320|"     The goal of this study is to translate laboratory findings that Quercetin, a bioflavonoid, is     safe and has antiviral activity in people with hepatitis C.   "
141021|NCT01438658|"     Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment is     effective, but patients still die of metastatic disease. It has been shown that early     diagnosis of a few isolated metastases can result in a clean surgical excision of the     metastases and an extension of the expected survival from 7-12 months to over 10 years on     some patients.      Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in     the diagnosis of metastatic uveal melanoma.      The investigators hypothesis is that a soluble serum biomarker level changes upon development     of metastatic disease either by secretion by the tumor cells themselves or by their     environment. Detection of changes in biomarker level may lead to the diagnosis of metastases     before they can be detected by imaging modalities, thus allowing for early treatment of the     metastases and a better chance of success.   "
141022|NCT01438645|"     Colonoscopy is an established technology that enables doctors to obtain live video from     inside patients' large intestines, which is essential for the diagnosis of numerous     intestinal illnesses. It consists of a long, flexible tube fitted with a light-source and     small video camera that transmits the images onto a display monitor. The doctor inserts the     scope into the anus, moves it into the rectum and then guides it slowly through the entire     colon. Because of the various twists and turns that are part of normal bowel anatomy,     advancing the scope through the entire colon is not always successful and can become     challenging when the scope forms loops inside the abdomen. Unfortunately, there is no way for     the doctor to see the shape of the scope inside the body other than what is seen from the     video at its front end, and so navigating the colon relies on instinct accumulated with     experience and the feel of the scope as loops begin to form. This is important because not     only can this loop formation cause pain, but it can also increase the likelihood of an     incomplete test. Incomplete tests matter because a major reason for performing colonoscopy is     colon cancer screening and surveillance; detecting early cancers at treatable stages and     looking for polyps that may be pre-cancerous growths. When colonoscopy does not advance     through the entire colon, parts are left unexamined where cancer may develop. A new     technology called ScopeGuide has been developed that uses magnetic coils embedded within     the scope to create a 3D image of the shape of the entire scope inside the body that is     projected onto the monitor for the doctor to see. This will show if loops are forming and     will provide information about how to eliminate loops once they have formed. In this research     study, the investigators will compare colonoscopy with the assistance of ScopeGuide to     colonoscopy performed in the standard fashion, to see if ScopeGuide results in more     successful procedures that are easier for the doctor and more comfortable for patients.   "
141023|NCT01438632|"     A previous study showed that absorption and glucose-lowering action of rapid-acting insulin     analogues occurred twice as fast when these analogues were administered by jet injection     technology rather than by conventional insulin pen in healthy non-diabetic subjects. This     study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with     jet-injection or a conventional insulin pen prior to a standardised meal in patients with     diabetes shows the same difference in the pharmacokinetic and pharmacodynamic profile.   "
141024|NCT01438619|"     Epidemiological, clinical and animal-experimental evidence shows a direct relationship     between dietary sodium intake, blood pressure and cardiovascular event. Diverse questionnaire     and 24 hour urinary sodium measurement are used to estimate sodium intake. Complete     reflection of eating and cooking habits to the dietary survey method is difficult.     Furthermore, the differences of database between countries make it difficult to compare the     amount of sodium intake between countries. It is also difficult to consider individual     variation of cooking and eating habits. Due to limitations of dietary survey method, WHO     recommended 24 hour urinary sodium measurement to estimated sodium intake in the population     survey, and many countries are adopting. However, in Korea National Health and Nutrition     Examination Survey, only dietary survey method has been used.      The present survey study was designed 1) to test the feasibility of 24 hour urinary sodium     measurement for the estimation of sodium intake (including percentage of complete 24 hour     urine sample collection) in the population based study; 2) to establish feasible method of 24     hour urinary sodium measurement; 3) to compare 24 hour urinary sodium measurement to the     dietary survey method; and 4) to estimate the sodium intake by 24 hour urinary sodium     measurement in Goyang city general population (aged 20-70 years).   "
141025|NCT01438606|"     The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in     HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine     that participants can safely receive.   "
141026|NCT01438593|"     The purpose of the study is to determine the safety and possible effectiveness of brain     transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.   "
141027|NCT01438580|"     Current guidelines recommend standard warfarin anticoagulation international normalized ratio     (INR) goal of 2.0-3.0 in adults with non valvular atrial fibrillation (NVAF). The     investigators hypothesized that low-intensity warfarin (INR 1.5-2.0) has the same     effectiveness and better security in elderly patients (>75) with NVAF.   "
141028|NCT01438567|"     The primary research objective is to demonstrate that subjects taking OXN PR have improvement     in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to     subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing     the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).   "
141029|NCT01438554|"     The purpose of this study is to determine the safety and toxicity of the combination of     pazopanib and GSK1120212 in patients with solid tumors and identify the maximum tolerated     dose (MTD) of this combination for phase II study.   "
141030|NCT01438541|"     This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable     subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular,     surgical and orthopaedic medical care in the elderly admission, with a high risk to develop     skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this     investigation.      The rational for this study is to evaluate the potential for Window in the prevention of     pressure ulcers because of its ability to reduce shear and friction forces.   "
141031|NCT01438528|"     This is a Chinese, Multicentre, Observational Study to study Adherence and Long Term Outcomes     of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone     treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
141048|NCT01438307|"     Lung cancer is the leading cause of cancer death worldwide and in the United States. The     majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases     are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains     limited at < 12 months median overall survival. New approaches are needed for second line     chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in     metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.   "
141032|NCT01438515|"     MRSA decolonization may reduce the risk of subsequent MRSA infection and further     transmission. A recent randomized controlled trial demonstrated that systemic decolonization     may be safe and effective among hospitalized patients when compared to no treatment. As a     large number of the investigators patients require re-admission and further transmission may     take place in the community, the investigators are comparing the standard decolonization     protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory     population.      Standard decolonization protocols, which use only topical agents, are limited in efficacy.     The method of systemic decolonization to be studied here appears to have greater efficacy     than the standard approach using only topical agents. However, concerns have been raised that     the increased use of systemic antibiotics may lead to increased levels of drug resistance     adverse effects, without sustained decolonization. This study seeks to provide further data     to help answer these questions and provide guidance for further policy development and     implementation.   "
141033|NCT01438502|"     The purpose of this study is to verify that an infusion of hypertonic saline/colloids during     cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with     expected long-CPB-time.      Expected beneficial effects are improved organ function for heart and lungs.   "
141034|NCT01438489|"     The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to     placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus     (SLE) with an inadequate response to standard of care treatment for SLE.   "
141035|NCT01438476|"     The goal of this clinical research study is to learn if there is a difference in patients'     quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after     surgery on the liver and/or pancreas. Researchers want to learn which method helps people to     recover more completely and more quickly after surgery.      The 2 kinds of pain control are intravenous (IV) pain management and epidural pain     management.   "
141036|NCT01438463|"     The objective of the present study is to characterize the dose-response relationship of     PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms     of clinical efficacy and safety.      For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due     to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of     treatment and at the end of the study patients will be subjected to a nasal provocation test.   "
141037|NCT01438450|"     Background Hepatocellular carcinoma, a malignant tumour of liver is one of the most common     cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care     hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in the     investigators Gastroenterology out patient department. Most of these patients present late     when the disease is already advanced and no curative therapies can be offered. At this stage,     palliative therapy forms the mainstay of treatment. This includes transarterial     chemoembolization (TACE) or Oral chemotherapy. Many patients also have involvement of     branches of portal vein, which further limit therapeutic options. According to Barcelona     Clinic Liver Cancer (BCLC) staging of liver cancer, involvement of portal vein precludes any     standard form of therapy. These patients have been recommended for experimental therapies.     Various forms of chemotherapy have been tried this group of patients. HCC is a vascular     tumour and thalidomide is an anti-angiogenic drug and inhibits vascularity and has been used     in the treatment of HCC. Capecitabine is a novel drug, which gives continuous delivery of     5-FU and has been used in patients with HCC and has been found to be safe.   "
141038|NCT01438437|"     The purpose of this study is to assess the efficacy of Radiofrequency ablation (RFA) and     percutaneous acetic acid ablation (PAI) in the management of small hepatocellular carcinoma     (HCC) in patients of cirrhosis of liver.   "
141039|NCT01438424|"     The purpose of this study is to provide entecavir to participants who have completed another     entecavir trial without achieving virologic response or who relapsed during postdosing     follow-up.   "
141040|NCT01438411|"     The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic     acid in subjects with identified inborn errors of bile acid synthesis.   "
141041|NCT01438398|"     The purpose of this study is to learn about the safety and usefulness of a procedure called     endoscopic submucosal myotomy, which is a new technique in the treatment of achalasia.     Achalasia is a disorder involving the lack of smooth muscle relaxation and sustained high     pressure in the sphincter (muscle) of the lower esophagus. This may result in symptoms such     as difficulty in swallowing, chest pain, regurgitation of food and eventually, weight loss.      For more than a decade, a laparoscopic surgical procedure known as Heller myotomy has been     the primary treatment for achalasia in patients with low surgical risk. In Heller myotomy,     the surgeon makes three to four small abdominal incisions, inserts tube-like instruments     through them, and once inside, the junction between the esophagus and stomach is found, a     lengthwise incision is made on the muscular ring surrounding the lower esophageal sphincter     which weakens the muscle and the lower esophageal sphincter or muscle (LES) is then able to     open more easily. However, there is an emerging field known as natural orifice (opening)     transluminal (through the lumen) endoscopic surgery (NOTES). This approach involves passing     an endoscope - a thin tube with a built-in camera, light and minuscule tools through the     natural opening in the body, like the mouth in order to perform less invasive surgery without     any external wounds or scars. The procedure is done using the Submucosal Endoscopy with     Mucosal Flap (SEMF) technique which involves passing an endoscope through the mouth into the     esophagus, where a small incision is made on the lining of the esophagus, known as the     mucosa. A balloon is then inserted and dilated in the submucosa - the layer between the inner     lining of the esophagus and the outer wall consisting of the muscle of the esophagus.     Dilation of the balloon in the submucosa creates a tunnel that allows insertion of the     endoscope and access to the muscle of the lower esophageal sphincter (LES). A long incision     is then carefully made on the posterior portion of the muscular ring that forms the LES. The     incision divides the muscle fibers of the LES, which weakens the muscle, allowing for the     easier passage of food while preserving some valve function to prevent reflux of acid from     the stomach into the esophagus.      The expected duration of participation is up to 10 years from the time study participants     undergo the endoscopic surgical procedure.   "
141042|NCT01438385|"     Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ),     Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year.     Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or     plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients     suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal     disorders. The investigators would like to assess prospectively the efficacy and safety of     these routine procedures to permit identification of technical details about the procedures     or other factors which might be associated with outcome or results. Assessment of these     details would help us with problem identification and recommendations to improve health     outcomes and quality of life in these patients.   "
141043|NCT01438372|"     The purpose of this study is to assess the safety and efficacy of intravenous iron sucrose in     comparison to oral ferrous sulfate in improving iron deficiency anemia in children with     inflammatory bowel disease.   "
141051|NCT01438268|"     Specific Aim: To assess the quality of recovery of patients following early discharge (18     hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed     using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days     (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed     on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.      Clinical Relevance: Postoperative recovery is a complex process related to various outcomes     such as physiological endpoints, incidence of adverse events and change in psychological     status. Previous studies of recovery after surgery and anesthesia have focused primarily on     the physiological endpoints and the incidence of adverse events. Much of the work has     occurred in specialties dealing with chronic disease states such as cancer, rheumatology and     musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in     the ambulatory population for postoperative recovery. Here the investigators propose to     measure postoperative recovery outcomes within the first week following a TRAM flap     reconstructive procedure using a validated postoperative quality of recovery instrument     (QoR-27) and a 100 mm VAS for pain.   "
141052|NCT01438255|"     This is a prospective, non-comparative, open, observational study.   "
141053|NCT01438242|"     The purpose of this study is to examine the potential impact of the assay in terms of     depression severity as measured by change in Clinical Global Impressions (CGI) scale at 3     months.   "
141054|NCT01438229|"     This is a prospective, multicenter, feasibility study on the safety and efficacy of renal     denervation in patients with resistant hypertension.   "
141055|NCT01438216|"     The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive     care patients.   "
141056|NCT01438203|"     The objective of this study is to investigate the comparative benefit of thrust and     non-thrust manipulation on a population of patients with low back pain. The investigators     hypothesize that there will be no difference in 4 week outcomes or greater, between the two     groups.   "
141070|NCT01438021|"     This pilot clinical trial studies continuous intraventricular methotrexate in treating     patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work     in different ways to stop the growth of cancer cells, either by killing the cells or by     stopping them from dividing. Giving drugs directly into the ventricles may be an effective     treatment for patients with leptomeningeal disease   "
141057|NCT01438190|"     Because many women with Polycystic Ovary Syndrome (PCOS) are very sensitive to the use of     gonadotropins, several strategies have been proposed to reduce the risk of Ovarian     hyperstimulation syndrome (OHSS) and multiple pregnancies.      The low dose step-up protocol and the step-down protocols in PCOS patients have been     described in literature.      The step-down regimen is designed to achieve the follicle stimulating hormone (FSH) threshold     through a loading dose of FSH with a subsequent stepwise reduction as soon as follicular     development is observed on ultrasound. On the contrary the step-up regimen is based upon the     principle of a stepwise increase in FSH supply to determine the FSH threshold for follicular     development. After commencement of gonadotropin administration, if follicle development is     not observed on ultrasound after 1 week, an increase in the dose is recommended. Once     follicle growth is observed, the same FSH dose is maintained until follicular selection is     achieved.      Preliminary studies report that both step-up and step-down regimens achieve similar high     rates of monofollicular development. However, the largest study published so far has shown     that the step-up regimen is safer in terms of monofollicular development.      Recent data demonstrate that metformin administration in infertile PCOS patients who are at     high-risk for OHSS reduces the incidence and severity of OHSS during gonadotropin ovarian     stimulation in a step-down regimen for in vitro fertilization (IVF) programs.      The aim of the present study will be to compare the conventional low dose step-up protocol     and the combined protocol consisting in metformin and gonadotropin step-down regimen.   "
141058|NCT01438177|"     This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together     with chloroquine works in treating patients with relapsed or refractory multiple myeloma.   "
141059|NCT01438164|"     Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.   "
141060|NCT01438151|"     The purpose of this study is to improve the investigators understanding of the relationship     between Crohn's disease and blood levels of the drug infliximab (Remicade). The investigators     want to determine whether measuring drug levels can be helpful in understanding how patients     respond to this treatment.   "
141061|NCT01438138|"     RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a     patient's risk of relapse and plan better treatment for acute myeloid leukemia.      PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how well     it works in predicting risk of relapse in bone marrow cell samples from younger patients with     acute myeloid leukemia.   "
141062|NCT01438125|"     The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a     hydrogel scaffold, in improving scars and their resulting consequences following     abdominoplasty or laparoscopy/laparotomy gynecologic procedures.   "
141063|NCT01438112|"     The use of a designed viral vector that can destroy cancer cells while leaving normal cells     largely unharmed. The virus also stimulates an immunological response by producing a special     factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It     forms the hypothesis that this regimen may be used for people who have failed current forms     of treatment and are recommended for cystectomy. It is with hope that this novel therapy will     be able to delay or potentially avoid cystectomy for this patient population. Bladder     instillation of this agent causes little long lasting side effects and may drastically     improve the stimulation of the immune system for local cancer cell death as well as     destroying those tumor cells that may have travelled to regional lymph nodes or distant     organs.   "
141064|NCT01438099|"     This study wants to investigate if ultrasound assisted epidural catheter insertion for labor     analgesia is easier and safer to the standard epidural technique.   "
141065|NCT01438086|"     When a patient has a heart attack, a blockage occurs in a coronary artery that delivers     oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body     naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the     heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs.     IGF-1 is also available as a drug called mecasermin. In this study, heart attack patients     will be given either a dose of mecasermin or a placebo (inactive treatment) after their     coronary artery has been opened by a stent. The purpose of the study will be to evaluate the     safety of the therapy and to test if the therapy will prevent or lessen heart failure by     evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight weeks after the     heart attack.   "
141066|NCT01438073|"     The investigators are looking for subjects to complete a study on the role of kisspeptin in     the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the     body to produce other reproductive hormones. However, giving someone a continued amount of     kisspeptin over a period of time can have the opposite effect and tell the body to, for a     short time, stop making hormones needed for reproduction. By giving 24-hour infusions of     kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way     bodies function normally and the role it has in conditions that affect the reproductive     system.      The investigators are initially seeking healthy men, healthy women with regular menstrual     cycles, and healthy postmenopausal women. In a later part of the study, the investigators     will also enroll subjects with reproductive disorders. Study participation involves 2     outpatient visits and one 38-hour hospital admission when subjects will receive kisspeptin     and Gonadotropin releasing hormone (GnRH).      Individuals interested in learning more may call 617-724-8764.   "
141067|NCT01438060|"     The primary objective of the study is to compare the efficacy of aripiprazole with placebo in     patients with psychosis associated with Alzheimer's dementia.   "
141068|NCT01438047|"     This is a pilot exploratory study. The goal of this study is to evaluate a new imaging tool,     optical frequency domain imaging (OFDI), to reveal the microvascular morphology of capillary     malformations.   "
141069|NCT01438034|"     The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a     diagnosis of delayed puberty. Study participation involves 2 outpatient visits and two     hospital admissions (one 11-hour, overnight admission and one 6-hour day admission) when     subjects will receive two investigational drugs, the naturally occurring hormones kisspeptin     and gonadotropin-releasing hormone (GnRH). Subjects will then be followed every 6 months     until they reach 18 years of age to determine if their pubertal delay was self-resolved or     permanent. Individuals interested in learning more may call 617-724-8592.   "
141071|NCT01438008|"     Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests     and injections. The investigators do not know if sugar also reduces pain in babies already     receiving a continuous infusion of opioid analgesics. This project will help determine if     small amounts of sugar water reduce pain in babies already receiving a continuous infusion of     opioid analgesic during a heel lance procedure or nasogastric/orogastric (NG/OG) tube     insertions. The investigators hypothesize that infants who are receiving opioid analgesics     will have lower pain scores during their blood tests (heel lance) or NG/OG tube insertion,     when sucrose is given, compared to when water is given.   "
141072|NCT01437995|"     This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group     comparative effectiveness study of approaches to stepping down therapy for patients with     well-controlled asthma treated with combination ICS and LABA.   "
141073|NCT01437982|"     The objective of this study is to identify any adverse events or adverse drug reactions     through post-marketing surveillance under routine clinical practice   "
141074|NCT01437969|"     More than 1.5 millions individuals are infected with HCV in Italy. They are at risk to     develop related morbidity and mortality from cirrhosis and hepatocellular carcinoma, unless     the evolution of their disease is halted by treatment-induced HCV RNA clearance. Indeed, it     is well recognized that a curative antiviral treatment, leading to HCV RNA undetectability 24     weeks after the end of therapy, may prevent the occurrence of complications of HCV chronic     liver disease.      Several pre-treatment host and viral factors have been associated with the outcome of     pegylated Interferon and Ribavirin treatment. These predictors are relevant as the ability to     identify patients with the highest likelihood of achieving HCV RNA clearance may increase the     number of patients who agree to be treated and who maintain their adherence to treatment.      Several pre-treatment predictors as HCV genotype, HCV viral load, age, gender, body mass     index, stage of fibrosis and race are very well recognized and have been used for many years     during the treatment decision-making process. Based on studies of viral kinetics, HCV RNA     undetectable at week 4 on treatment has been shown to represent the best on treatment     predictor of response. In addition to these well known factors, very recently, a single     nucleotide polymorphism (SNP) upstream of the gene IL28B on chromosome 19, coding for     IFN-lambda 3 has been identified as associated with both spontaneous and treatment induced     HCV RNA clearance.      We have developed the molecular technique needed to evaluate this polymorphism in our     laboratory. This technical process was a consequence of the genetics expertise of our     research Institute. We have also performed a valuable comparison of the different methods to     evaluate this polymorphism. Comparison of different technologies allow us to know the rate of     variability between the different assays used.      With this methodology we have evaluated a posteriori patients previously enrolled in     Randomized Controlled Trial. The results of these studies confirmed the association between     IL28B CC allele and a favorable outcome of HCV infection in our geographic area (Mangia et al     Gastroenterology 2010; Mangia et al Hepatology 2010, AASLD presentation). We are now     interested in prospective evaluation of patients referring to our center at the aim of     understanding whether there are differences in the rates of IL28B frequencies in patients     with different HCV genotypes.      In fact, we hypothesize that the frequency of IL28B might be different according with     different HCV genotypes and that this difference may explain the different rates of response     to antiviral treatment reported in patients with HCV infection.      Since we lead a collaborative group of hepatologists named AL-LIVER operating in Puglia,     Lazio, Basilicata, Sicilia and Campania regions in Italy we would like to extend this     evaluation to our collaborative group to explore in a large number of patients whether the     prevalence of CC, CT and TT genotypes is inversely associated with HCV G1, 4, 3 and 2.   "
141075|NCT01437956|"     Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory     Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity     has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis     seems to be different according to the respiratory causative virus. The investigators propose     to study, during an epidemic season, the correlation between KL-6 levels and clinical     severity, and the type of viral infection.   "
141076|NCT01437943|"     The purpose of this study is to evaluate the effect of a short-term aliskiren treatment on     kidney metabolism in patients at high risk for developing kidney dysfunction (i.e. kidney     transplanted patients). The study is aimed at evaluating if any effect on kidney metabolism     [using proton MR Spectroscopy(1H-MRS)] can be detected following a 6 months treatment with     aliskiren regardless of its anti-hypertensive role. 1H-MRS can record a larger number of     chemical species (up to 40) in the kidney, and monitor changes according to the pathologic     state and health of the transplanted kidney.   "
141077|NCT01437930|"     The study was performed to investigate the effects of a daily consumption of n-3 PUFA     supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk     factors in hypertriglyceridemic patients.   "
141078|NCT01437917|"     The consumption of cereals-based foods with low glycemic indexes, high micronutrients and     fibers contents are highly recommended. The target of this work is to provide new solutions     for cereal based foods: the knowledge and understanding on the in vivo fate will be used to     define structural features to gain in foods.   "
141079|NCT01437904|"     Outpatient tubeless Percutaneous nephrolithotomy (PCNL) could potentially improve patient     care and result in significant cost savings for our hospital each year. If this pilot study     is successful, Queen's/KGH will lead a collaborative national multicentre trial to further     establish the role of this new approach in the surgical treatment of kidney stones.   "
141080|NCT01437891|"     An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and     Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).   "
141081|NCT01437878|"     This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to     evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to     COPD. The main objective is to investigate the effect of iloprost on exercise endurance time     during constant work rate cardiopulmonary exercise testing. Other efficacy and safety     endpoints will additionally be analyzed.   "
141082|NCT01437865|"     The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared     to current nodal staging methods.      The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged     nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will     be regarded as the golden standard for nodal involvement.   "
141083|NCT01437852|"     The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study     evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the     healing of the deep partial-thickness component of complex skin defects. The proposed study     population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin     defects including a deep partial-thickness component resulting from thermal injury. The study     has been designed to focus on the evaluation of safety and tolerability of prolonged exposure     to increasing amounts of a single application of StrataGraft skin tissue, while also     assessing the potential for StrataGraft tissue to promote healing of the deep     partial-thickness component of these complex skin defects as an alternative to donor site     harvesting and autografting. Targeted enrollment for this study is up to 30 patients with     complex skin defects due to thermal burns which require surgical excision and autografting.     Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving     StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third     cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in     the operating room just prior to grafting.   "
141084|NCT01437839|"     To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial     image tablets.   "
141085|NCT01437826|"     The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin     A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large     bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the     incidence of metachronous adenomas was expected in patients allocated to the active     compound (intervention) arm as compared to those assigned to a placebo.   "
141121|NCT01437358|"     Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the     intensive care unit settings, EA should be proposed in critically ill patients, such as     postoperative or trauma patients, typically. Recent findings also support anti-inflammatory,     vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA     safety and feasibility in the intensive care unit settings are still lacking. The purpose of     this observational prospective study is to describe the safety and feasibility of this     analgesia technique in ICU patients.   "
144205|NCT01396876|"     The investigators hypothesized that the participation of therapeutic clowns in the pediatric     emergency department procedure room would reduce anxiety, improve the level of cooperation     children can provide and avoid some of the adverse effects.   "
141086|NCT01437813|"     Objective:      The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of     the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy     Mexican volunteers.      Methods: A prospective, longitudinal, open label, non randomized study, was performed. A     single oral dose of GLI/METXR (4/850 mg)was administered to 24 health Mexican volunteers 30     min after a high fat meal. Blood samples were collected before the administration and 0.33,     0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours     post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma     concentration of botk drugs were measured using high-performance liquid chromatography     (HPLC). Plasma concentration time curves were plotted for each volunteers, and     pharmacokinetic parameters (PK) were calculated. Adverse events were determined using     clinical and laboratory test results throughout the study.   "
141087|NCT01437800|"     Objective:      The purpose of this study is to evaluate the oral bioavailability of the combination     Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers.      Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24     volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg). Blood samples     were collected over 30 hours. Plasma concentration of both drugs were measured by using     high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted     for each volunteer, and pharmacokinetic parameters (PK) were calculated. Adverse events were     determined using clinical and laboratory test results, throughout the study.   "
141088|NCT01437787|"     Primary Objective:        -  To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503          (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen          volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in          patients with contraindications for MRI).      Secondary Objectives:        -  To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.        -  To evaluate the Overall Survival of patients treated with either 400 mg/day or 500          mg/day of IMP as compared to placebo.        -  To evaluate the Progression Free Survival of patients treated with either 400 mg/day or          500 mg/day of IMP as compared to placebo.        -  To evaluate the durability of splenic response.        -  To evaluate the safety of IMP.   "
141089|NCT01437774|"     The ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing     thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial     will be randomized to treatment with the ReStore™ Thrombectomy Device (investigational     treatment) or to treatment with a commercially available thrombectomy device It is expected     that the investigational treatment safety profile in terms of clinically significant     procedural adverse events will be comparable to the control group.   "
141090|NCT01437761|"     This study will compare how well blood of renal failure patients is cleaned with the new 2008     Sorbent System using two different dialysate speeds.   "
141091|NCT01437748|"     -  The gold standard measures to evaluate small airways (SAW) in vivo is not well          understood        -  Two tests are today used to measure SAW but real results concordance is not clear        -  These problems have a small evidence        -  Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has          never been studied        -  Only an acute bronchodilators effect, after one hour of drugs inhalation, will be          evaluated        -  The time frame of study evaluations per patient will be of three hours: one hour for          basal test; one hour rest after drug administration; one hour for post bronchodilators          test        -  All enrolled subjects will be outpatients and will be evaluated after 24 hours of          inhalatory drugs washout   "
141092|NCT01437735|"     This study aims to demonstrate a clinically significant improvement in Forced Expiratory     Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled     by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active     comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging,     multi-centre trial.   "
141093|NCT01437722|"     The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the     prevention of recurrence of bacterial vaginosis.   "
141118|NCT01437397|"     The purpose of this Phase III study is to assess the maintenance bronchodilator effects of     the fixed dose combination versus monotherapies. This study will also assess the effects of     the fixed dose combination in terms of COPD symptoms, disease related health status and the     long-term safety and tolerability of the fixed dose combination. This study will include a 24     week treatment period, preceding by a run-in period, followed by a two week follow up visit.     All patients will be randomized to one of four treatment arms or placebo.   "
141094|NCT01437709|"     This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of     treatment are to control the lymphoma with the least amount of side effects. In many cases,     MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced     substance created to attach to proteins on the cancer cells, eventually destroying them.     Chemotherapy is medicine that specifically destroys cancer cells.      The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab     and Bendamustine have on this type of cancer. Patients in this study will either receive     Ofatumumab alone, or Ofatumumab combined with Bendamustine.   "
141105|NCT01437566|"     This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase     II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC)     who have experienced recurrence or progression of their disease while receiving aromatase     inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI     therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have     received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of     this study. Part I of the study will assess the effect of the addition of GDC-0941 to     fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS)     compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and     tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D)     on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with     an AI and whose tumors contain a PIK3CA mutation.   "
141095|NCT01437696|"     Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the     skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk     and margarine. This study has 3 main goals which are to determine if Veteran's have enough     vitamin D stored in their body, if adding a supplement of 2000 IU/d is enough to correct low     vitamin D stores and, if specially formulated foods using an approved vitamin D supplement,     are appropriate to maintain vitamin D stores in relation with functional and cognitive     status. Initially, a 2000 IU supplement of vitamin D will be provided for 8 weeks. After this     period, the participants will be randomly separated into 3 groups (Group A, B or C) for a     period of 24 weeks. Group A will receive their usual menu. Group B will receive their usual     menu with 1 portion of food containing 500 IU of added vitamin D. Group C will receive their     usual menu with 1 portion of food containing 1000 IU of added vitamin D. Food intake will be     assessed every 8 weeks and blood samples will be taken every 4 weeks to monitor change in     blood concentration of vitamin D and other indicators of bone health. The investigators will     document weight and height, hand grip strength, the mid-arm and mid-calf circumferences, the     capacity to perform activities of daily living, the number of prescriptions and changes in     health condition. The investigators will also take an X-ray the tibia and upper arm to     document the amount and quality of bones in those regions. A total of 60 veterans of     Ste-Anne's Hospital will participate in this study. Knowing more about vitamin D status and     intake will help in confirming the required vitamin D recommendations for the elderly men     living in long-term care institutions.   "
141096|NCT01437683|"     The primary objective of the protocol is to study the long-term outcome of a large group of     traumatic brain injury patients.      This outcome is to be described in terms of activity, participation, quality of life,     SOCIO-professional outcome and impact on caregivers, and in relation to health care     provision.      The secondary outcome is to measure the impact on functional outcome of several predictive     factors, and their relative importance on outcome. Our principal hypothesis is that     SOCIO-professional and health provision factors play a major role on long-term outcome,     further even than initial severity of brain injury.   "
141097|NCT01437670|"     A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with     solifenacin   "
141098|NCT01437657|"     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the     safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive     disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on     study treatment is 6 weeks with a 3-week follow-up.   "
141099|NCT01437644|"     Cerebral palsy is common. It affects approximately 3 per 1000 children. Hip displacement due     to muscle tightness (spasticity) occurs in up to half of the more severely affected children,     and many of these children require major (bony) hip surgery. After bony hip surgery the     management of pain is very difficult, as spasticity tends to increase and causes painful     spasms which are difficult to control. Botulinum Toxin injections are known to reduce     spasticity and therefore should also reduce pain. These injections take at least a week to     work, but the effects can last for months. Botulinum Toxin is already an established     treatment for chronic hip pain prior to surgery. The investigators aim to find out whether     Botulinum Toxin injections can reduce post-operative pain. The identification of the level of     pain can be challenging because most of these children are unable to communicate verbally.     The investigators are therefore using a validated pain scoring tool that was designed     especially for such children. This study will be the first to describe fully the pain     experience of children with cerebral palsy undergoing this type of major surgery. The     investigators will compare Botulinum Toxin injections with placebo (non-active) injections.     There is a high emotional and financial burden on the families of these children. Families     describe high levels of emotional distress around the time of surgery, particularly when     their child is in pain. Difficulty with pain control post operatively may delay discharge     from hospital and parental return to work. It causes disrupted sleep for the child and family     and may delay the child's return to school. The results of this study will be shared with     professionals and families at international conferences and in scientific and popular     (patient-based) publications. This study cannot be undertaken in adults with cerebral palsy     as they only rarely undergo this sort of surgery.   "
141100|NCT01437631|"     The aim of this study is to evaluate the efficacy of prophylactic clip application after     colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate     postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).   "
141101|NCT01437618|"     The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as     first-line treatment could be considered a promising approach to improve the outcome of BRAF     mutant metastatic colorectal cancer patients   "
141102|NCT01437605|"     The overall purpose of this research study is to find a better way to treat melanoma.      The goals of this study are:        1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 +          AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC        2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with          or without the Poly IC:LC        3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment          with or without the Poly IC:LC        4. To measure the rate of return of the patient's tumor in two groups of patients: one          group positive for the gene signature, and the other group not positive for the gene          signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly          IC:LC.   "
141103|NCT01437592|"     This trial was conducted in Asia. The aim of this trial was to investigate the     pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250     (insulin degludec) in healthy Chinese subjects.   "
141104|NCT01437579|"     The etiology of bladder pain syndrome is unknown. Therefore the management is directed to     pain relief, as bladder pain is believed to drive both voiding frequency and nocturia.     Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy     of botox for treatment of painful bladder.      The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are     suffering bladder pain syndrome with Hunner lesions during cystoscopy.   "
142847|NCT01414725|"     The primary purpose of this study is to determine whether a 12 week Pilates based core     stability training programme is effective in improving balance, mobility and balance     confidence in ambulant individuals with Multiple Sclerosis (MS).   "
141106|NCT01437553|"     The iWONDER trial has the following objective:      To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic     plaques angiographically considered culprit and not-culprit in patients undergoing     coronary angiography due to STEMI (ST-elevation myocardial infarction).   "
141107|NCT01437540|"     The purpose of this study is to assess the long-term safety and tolerability of inhaled     aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive     pulmonary disease (COPD).   "
141109|NCT01437514|"     The local recurrence of rectal cancer is one of the main problem that fail the treatment. The     preoperative neoadjuvant (chemo)radiotherapy has been confirmed to reduce the local     recurrence rate,especially in the advanced rectal cancer. However the local recurrence rate     is low about 10-20% totally,and the integrity of the mesorectum after the operation and     circumferential resection margin(CRM) are the most critical factor for the local     recurrence.So that, the advanced rectal cancer patients with negative CRM and had a complete     mesorectum excision,may not benefit from the neoadjuvant radiation.This trial was mainly     focus on the resectable advanced rectal cancer patients whose preoperative stage was cT3/N+.     These patients will be divided into the lower risk group and higher risk group according the     preoperative CT,Endoscopic ultrasound, and MRI,and carrying out randomized trial in the two     groups respectively.The purpose of this trial is to confirm whether the preoperative     radiotherapy is necessary for all the advanced rectal cancer patients,identify the reason of     the local recurrence,and finally help the making of the treatment decision for the advanced     resectable rectal cancer.   "
141110|NCT01437501|"     This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be     conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships     will be screened and three hundred eligible individuals will be enrolled in the study.     Participants will be randomized into two treatment groups: one will receive a juice beverage     containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice,     lime juice, and water and the other will receive a placebo beverage containing pineapple     juice, lime juice and water. Participants will drink their assigned beverage every evening     and provide biweekly urine samples and monthly blood samples. The principal endpoints of this     study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their     metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of     exposure biomarkers for dietary and air-borne toxins, which are known to be high in this     population.   "
141111|NCT01437488|"     There is no accepted standard chemotherapy approved for use in the second line for patients     with advanced urothelial carcinoma whose cancer has progressed on combination chemotherapy     including either cisplatin or carboplatin. The chemotherapy class called taxanes, either as     single agents or in combination, have demonstrated modest efficacy in small studies.     Cabazitaxel is an agent in the taxane family designed to be active in the setting of acquired     multi-drug resistance that arises in some tumors. The objective of this study is to evaluate     the safety and efficacy of this agent in patients with urothelial carcinoma refractory     compared to combination platinum based chemotherapy.   "
141112|NCT01437475|"     HBV vaccination is of paramount importance among HIV positive persons due to an increased     risk of infection and disease progression. The most widely used ENGERIX B vaccine reaches a     lower rate of vaccination (20-70%) among HIV positive vaccinees (compared to over 90% in the     normal population). Sci-B-Vac is novel vaccine containing 3 antigens and is therefore more     immunogenic (as opposed to one in ENGERIX B). Its use has been associated with higher and     more rapid vaccination rates. Therefore, it has a theoretical advantage in HIV positive     individuals.   "
141113|NCT01437462|"     The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not     proven in a large-scale study. The researchers aim to provide an investigation that has     sufficient power to clarify the potential effect of anaesthetic method on postoperative need     of opioids. Sevoflurane and propofol will be compared.   "
141114|NCT01437449|"     Docetaxel and cetuximab are FDA approved for the treatment of squamous cell carcinoma of the     head and neck. Cisplatin and carboplatin, while not FDA approved for Squamous Cell Carcinoma     of the Head and Neck (SCCHN), have been used as standard of care in patients with SCCHN in     combination with other drugs. This study will determine if weekly cisplatin and docetaxel, in     combination with cetuximab, will be effective in palliative treatment of patients with     squamous cell carcinoma of the head and neck. These drugs will be given intravenously weekly,     repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse     events.   "
141115|NCT01437436|"     Obesity is associated with increased risk of surgical complications. Ventilation tube     insertion is one of the most frequent surgical procedures performed on children. However, the     impact of obesity on surgical results or surgical related complication following ventilation     tube insertion remains poorly understood. The aim of this study was to investigate the effect     of obesity on the surgical results of ventilation tube insertion for otitis media with     effusion (OME) in pediatric patients.   "
141116|NCT01437423|"     The purpose of this study is to assess the safety of TETRAXIM™ administered in routine     clinical practice according to Korea Food and Drug Administration Notification No. 2009-46     Basic standard for reexamination of new drug based on the pharmaceutical law in Korea.   "
141119|NCT01437384|"     36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete     the entire study. The study will consist of a pre-treatment phase and a treatment phase. The     pre-treatment phase will include screening and baseline period 1. The treatment phase     consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral     dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose;     Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant     administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each     treatment period. The screening period will be up to 13 days in duration. After fulfilling     screening requirements, subjects will check into the clinic on Day -1 for baseline     assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment     Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient     visits. They will be domiciled in the clinical testing facility for at least 14 days for     Treatment Period 2 and will return intermittently for study procedures for 7 outpatient     visits.   "
141120|NCT01437371|"     The purpose of this study is to determine if there is an interest to optimize HF (heart     failure) management in patients over 80 years old. The primary objective is to assess the     effect of HF (heart failure) optimized management (guidelines of the European society of     Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.   "
141133|NCT01437202|"     This is a multicenter, retrospective, observational study to validate a pharmacogenetics     model for imatinib metabolism and resistance in patients with chronic myeloid leukemia among     patients in different independent cohort.   "
141122|NCT01437345|"     This study is an observational study that aims to advance our knowledge on infantile onset     FSHD. The study will include 50 participants of all ages who have presented with symptoms of     FSHD between birth and 10 years of age. Study participation will involve a single day of     assessments at one of the participating CINRG centers (to include physical exam, cognitive     testing, eye exam, hearing test, strength testing and speech evaluations). The procedures may     be split over additional days for scheduling purposes.   "
141123|NCT01437332|"     Specific proteins and other signaling molecules are increased and decreased following nerve     injury. Some of these are important in producing pain or explaining why pain persists after     traumatic nerve injuries or in disease states such as diabetes. In this study, the     investigators hypothesize that it is possible to detect changes in specific signaling     molecules and that these will provide insights into novel treatment strategies. The patients     to be included are those who are undergoing the removal of tissue during surgery. The tissues     that would otherwise be discarded will be included in the study as appropriate.   "
141124|NCT01437319|"     The purpose of this study is to determine if the formation of mucin balls is a marker for     protection from inflammatory events to the cornea and if mucin balls play a role in     protection during extended contact lens wear.   "
141125|NCT01437306|"     The objective of this single-dose, open-label, randomized, two-period, two-way crossover,     food-effect study is to evaluate the effect of food on the rate of absorption and oral     bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured     by US WorldMeds, LLC.   "
141126|NCT01437293|"     An inpatient safety study to characterize the cardiovascular and behavioral effects of     cocaine administration in the presence of LCE. The proposed study involves an inpatient stay     of 12 days during which participants will have two cocaine-administration sessions, each     including five doses of smoked cocaine with ascending doses.   "
141127|NCT01437280|"     Oncolytic viruses are viruses that can be found in nature, but they have been modified so     that they can no longer multiply in normal cells. These viruses infect cancer cells and     kill them. Once the cancer cell dies thousands of the viruses are released and can     potentially infect other cancer cells in the area. The effects of oncolytic viruses on the     tumor are felt to be the result of a combination of the oncolytic viruses directly killing     the tumor cells as well as the patient's immune system killing cancer cells that are infected     with the oncolytic virus.      Modern oncolytic viruses have been used for treatment of thousands of patients. The safety of     such treatments has been good and there have been no deaths caused by treatment with     oncolytic viruses. Many patients have benefited from the treatment in the sense that their     tumors have stopped growing, become smaller or even completely disappeared. Some benefits are     temporary, but about one third of patients seem to gain longer lasting benefit likely to     impact survival. The effect of oncolytic viruses on improving survival has not been     demonstrated yet.      Oncolytic viruses can be created from many different types of viruses. In this study the     investigators are using an oncolytic virus created from an adenovirus. Adenoviruses are the     types of viruses that cause the common cold and the flu. Because replication in normal cells     does not take place, these oncolytic viruses should not cause any diseases in normal cells.     Further, to date there has been no incidence of passing the virus on to other humans from     patients who were treated with oncolytic viruses.      The purpose of this study is to see the highest dose of CGTG-102 (the oncolytic virus being     used in this study) that can safely be given to subjects. The investigators will also     evaluate whether or not the CGTG-102 is helpful in reducing the size of the cancer and     improving patient survival.   "
141128|NCT01437267|"     This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the     Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid     Fever is highly endemic and an efficacious vaccine against this disease is very much needed.   "
141129|NCT01437254|"     Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate     [GPERT] scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to     radioactive iodine therapy. The first 10 subjects will receive one CPTERT [cyclotron made]     Tc-99m Pertechnetate scan after surgery. Vital signs and blood work, pre-injection and     post-imaging will be done. The second group of 20 subjects (2 for each CPERT subject) will be     matched as to age and gender and have a GPERT scan for qualitative comparison.   "
141130|NCT01437241|"     The purpose of this study is to evaluate the virological and clinical efficacy of etravirine     plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected     patients. Additionally, the safety of these regimens, specially lipid profiles, will be     assessed.   "
141177|NCT01436617|"     The main objective of this study is to validate the utility of IgE anti-cetuximab in the     treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab     (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe     reactions.   "
141178|NCT01436604|"     The main objective of this study is to compare the proportions of late enhancement in     patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group     consisting of patients who did not have LV dysfunction after 6 months under the same     treatment.   "
141131|NCT01437228|"     Cesarean delivery rates are increasing in Turkey and a major component of this increase is     cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a     national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of     endomyometritis and wound infection, remains a leading cause of postoperative complications.     Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and     obstetric variables. Infection following cesarean delivery results in not only increased     hospital stay but also increases the cost of care. Strategies to minimize postoperative     infectious and other morbidities have included modifications of surgical technique, changing     of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and     altering the uterine position during repair of the uterine incision. Despite these     interventions, endometritis is still major problem after cesarean delivery.      Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing     an important role. The microbes endogenous to the vagina change throughout the course of     pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the     vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand,     reaching below the infant's head or presenting part, is in direct contact with the vagina.     Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95%     confidence interval [CI] 58%, 100%) of cesareans that follow labor. In these cases, vaginal     flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision.     Vaginal preparation has been shown to decrease the quantitative load of vaginal     microorganisms as well as to remove certain species of bacteria.   "
141132|NCT01437215|"     The purpose of this study is to determine whether the Endologix fenestrated stent graft     system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic     aneurysm.   "
141138|NCT01437137|"     Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has     been shown in several large observational studies, findings suggest that the smaller-sized     c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general     anesthesia in small infants and that they may even be associated with more frequent     complications than with the facemask and endotracheal tube. The pediatric i-gel is a new     supraglottic airway device for children. It is made of a soft, gel-like elastomer with a     noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy     insertion, high airway leak pressures, and low complication rates with few postoperative     complaints. The aim of this study is to compare clinical performance of the pediatric i-gel     and c-LMA in infants.   "
141139|NCT01437124|"     The investigators aim to measure the blood levels of certain metals in a group of patients     all of whom have had a ceramic on metal total hip replacement. This new bearing surface     (joint) is relatively new and the investigators are currently following up the largest cohort     in the world. Clinical results are currently excellent at 2 years in all patients, however     the investigators are mindful of the lessons learned from the high failure rate of several     designs of metal on metal hip replacements as well as several in vitro reports and one in     vivo case report of elevated metal levels in this particular implant. The investigators feel     it is important to measure the metal ion levels in our group to ascertain and compare these     with reference standards. Once performed the investigators can relate ion levels to function     and x ray changes and provide useful longterm data to the patients and the wider medical     community as to whether this bearing surface is safe in the long term or whether it's use     should be abandoned. This is useful as there are numerous groups implanting this device in     the UK and in addition it has just been awarded FDA approval in the USA - its use is likely     to flourish.   "
141140|NCT01437111|"     This study will assess the effect of 26 weeks of once-weekly treatment with     MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600)     on serum levels of 25-hydroxyvitamin D [25(OH)D].   "
141141|NCT01437098|"     The primary objective of the present trial is to demonstrate the effectiveness and safety of     the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed     difficult for surgical operation.   "
141142|NCT01437085|"     Prostate brachytherapy is an effective treatment option for men with localized prostate     cancer, with excellent cure rates and a favorable toxicity profile. With the current needle     insertion technique, seed placement inaccuracy is primarily caused by needle deflection and     soft tissue deformation, which both occur during the brachytherapy operation. This study will     accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of     ultrasound images, video clips and one CT scan.   "
141143|NCT01437072|"     This study is conducted in the Middle East, Northern Africa and Europe. The aim of this study     is to contribute to the design of a simple screening strategy for countries in scope, by     exploring the association between risk factors and undiagnosed diabetes in a screening study.   "
141144|NCT01437059|"     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and     pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol     (LDL-C).   "
141179|NCT01436591|"     The primary endpoint of this study is to show that this algorithm in high definition is     superior to the classical algorithm in the diagnosis of lymph node metastases.   "
141145|NCT01437046|"     Only three medications are approved by the Food and Drug Administration (FDA) for the     treatment of alcohol dependence (AD), namely disulfiram, naltrexone tablets and injection,     and acamprosate, however treatment success has been inconsistent. Thus, there exists a     substantial need for discovering ways to provide more effective treatments. Pre-clinical and     clinical evidence has clearly demonstrated that the noradrenergic (NE) system is involved in     the neurobiology of AD, thus representing an interesting new pharmacotherapy target and the     theoretical rationale for this proposal. Consistent with the concept that the NE system may     represent a new pharmacological target for AD, recent studies have shown that the prototype     alpha-1 NE receptor antagonist prazosin reduces alcohol drinking in different animal models.     Furthermore, clinical evidence has also confirmed that prazosin appears to be efficacious in     reducing alcohol consumption in alcohol-dependent individuals. While prazosin has a     significant side effect profile and must be taken three times a day, no other α1-blockers     have been investigated in alcohol research. Prazosin is a short-acting α1-blocker approved to     treat hypertension (HTN) and benign prostatic hyperplasia (BPH). After the approval of     prazosin in the 70's, other selective α1-blockers have been developed to treat HTN and/or     BPH. Among them, doxazosin has shown a more manageable and safer profile than prazosin. In     fact, doxazosin is a long-acting α1-blocker, thus it is taken only once/day. Doxazosin is     also less likely to give hypotensive side-effects. Thus, doxazosin is more commonly used in     clinical practice to treat HTN and/or BPH, than short-acting α1-blockers, such as prazosin.     Poor adherence to medications and/or side-effects represent important factors limiting the     effectiveness of pharmacotherapies for patients with AD. If effective for AD, doxazosin may     represent a simple, manageable and safe medication, which might be more easily transferable     to clinical practice. However, doxazosin has never been tested in AD. This project is a     10-week, double-blind, placebo-controlled, between-subject randomized clinical trial with     doxazosin (16mg once/day) in alcohol dependent (AD) individuals. This study attempts to     address whether doxazosin is an effective and safe pharmacotherapy for AD.   "
141146|NCT01437033|"     Background:      - Some types of cancer, like cancer of the esophagus, are difficult to detect at an early     stage. A possible detection method involves collecting breath samples to look for chemicals     that may be signs of cancer. However, more research is needed to determine how different     chemicals appear in different breath samples. This study will involve healthy volunteers.      Objectives:      - To study chemicals appearing in breath samples of healthy volunteers.      Eligibility:      - Healthy volunteers between 30 and 60 years of age.      Design:        -  Participants will fast overnight (midnight to morning) and then provide two breath          samples taken 5 minutes apart.        -  Breath samples will be collected on days 1, 49, and 98 of the study   "
141155|NCT01436916|"     Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D     deficiency is also high i.e. 78-96% in different groups of population in north India.     Observational studies find association between low Vitamin D status and type 2 diabetes     mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year     .There is mechanistic support that vitamin D may influence both insulin secretion and insulin     sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective     studies support the role of vitamin D in the prevention of T2DM. This study will be a single     blind randomized placebo controlled trial to study the effect of oral cholecalciferol in     insulin sensitivity and secretion in adults with prediabetes who are also vitamin D     insufficient.   "
141156|NCT01436903|"     CavatermTM is a second-generation thermal balloon ablation device in the management of     menorrhagia. The purpose of this study is to investigate the success (questionnaire) of     CavatermTM dependent on uterus probe length, especially corpus probe length, which is     measured during surgery.   "
141147|NCT01437020|"     Background:      - Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The     parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also     affect the blood and immune system. One possible treatment for VL involves an experimental     drug called SCH708980, which may help to prevent the immune system from becoming suppressed     and worsening the VL. Researchers want to give the drug along with AmBisome(Registered     Trademark), which kills the parasites, to see if it is a safe and effective treatment.      Objectives:      - To study the safety and effectiveness of SCH708980, alone and combined with     AmBisome(Registered Trademark), as a treatment for visceral leishmaniasis.      Eligibility:        -  Individuals 18 to 60 years of who have been diagnosed with visceral leishmaniasis in the          past 4 to 5 days, are HIV-negative, and are willing to stay in the hospital for 30 days.        -  All participants will come from and be treated at the Kala-Azar Medical Research Center          in Muzaffarpur, India.      Design:        -  This is a two-part study. Participants will be assigned to only one part of the study.        -  Participants will be screened with a medical history and physical exam; blood, urine,          and stool samples, spleen or bone marrow samples; spleen measurements; a chest xray; and          a heart function test.        -  Part 1 participants will be separated into two groups: a larger group will have a          selected dose of the study drug followed by AmBisome 7 days later, and a smaller group          will have a placebo treatment followed by AmBisome.        -  Part 2 participants will have either the study drug or a placebo plus AmBisome, based on          the test results from the Part 1 participants.        -  All participants will be monitored in the hospital for 30 days, and will have the          following tests:        -  Regular blood samples        -  Urine and stool samples (day 14)        -  Spleen measurements (days 8, 14, 21, and 30)        -  Spleen or bone marrow sample (day 30 only). Participants who still have VL symptoms will          give another sample on day 45.        -  At 6 months after the start of treatment, participants will have a follow-up visit with          spleen measurements, blood and stool samples, and possible spleen or bone marrow samples   "
141148|NCT01437007|"     Background:      Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular     cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas,     gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People     who have tumors that can be removed by surgery live longer than those whose cancer cannot be     removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live     longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by     surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this     study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in     the liver circulation, to see if it will cause tumors to shrink.      Objectives:      - To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not     responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age who have inoperable cancer that has started in or     spread to the liver.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood tests, and imaging studies.        -  Participants will have a liver angiogram (type of X-ray study) to look at the blood flow          in the liver and to place a catheter for delivery of the TKM080301.        -  Participants will have a single dose of TKM-080301 given directly into the liver. After          the drug has been given, the catheter will be removed. They will have frequent blood          tests and keep a diary to record side effects.        -  Participants may have two more doses, each dose given 2 weeks apart. {Before each dose,          participants will have another angiogram and catheter placement.}They may also have          liver biopsies to study the tumors.        -  Two weeks after the third treatment (one full course), participants will have a physical          exam, blood tests, and imaging studies. If the tumor is shrinking, they may have up to          three more courses of the study drug.        -  Participants will have follow up visits every 3 months for 2 years after the last course          and then every 6 months as required.   "
141149|NCT01436994|"     The investigators aim to establish whether biochemical control during anti-thyroid drug     therapy in young people with thyrotoxicosis varies depending upon whether a 'block and     replace' or 'dose titration' regimen is used. The investigators will also assess remission     rates and the frequency of side-effects in the two treatment groups.   "
141150|NCT01436981|"     The purpose of this study is to determine the pharmacokinetic of papaverine after     administration into the artery mammaria interna.   "
141151|NCT01436968|"     The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in     combination with radiation therapy for patients with intermediate-high risk localized     prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing     tumor cells in an immune stimulatory environment induces the body's immune system to detect     and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity     and lower than expected recurrence rates in previous clinical trials. The hypothesis is that     ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer.     Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms     receive standard external beam radiation therapy. Short-term androgen deprivation therapy may     be given but is not required.   "
141152|NCT01436955|"     This multi-center, randomized double-blind, placebo-controlled study will assess the safety     and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be     randomized in cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated     time on study treatment is 38 days.   "
141180|NCT01436578|"     This study will examine the safety and efficacy of posaconazole in general use in Korea.      Post-marketing surveys are not considered applicable clinical trials and thus the results of     this survey will not be posted at its conclusion. The results will be submitted to public     health officials as required by applicable national and international laws.   "
141204|NCT01436253|"     This study is being done to see whether dietary and medicinal measures compliant with     hyperlipidemia treatment guidelines will result in achieving target lipid values and to     evaluate the total risk of cardiovascular disease in study participants who have not reached     satisfactory lipid levels with their current hypolipemic therapy.   "
141153|NCT01436942|"     Background:      Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together     with medication. Last years, increased risk of cardiovascular diseases in patient with     inflammatory diseases is reported, probably caused by inflammation and increased prevalence     of traditional risk factors. In both healthy adults and other patient groups,     cardiorespiratory and muscular strength exercises have been shown to have a positive effect     on inflammation as well as on cardiovascular risk factors. To our knowledge this has not been     shown in patients with ankylosing spondylitis.      Objective: The aim of this study is to investigate the effects of a cardiorespiratory and     muscular strength exercise program on disease activity and cardiovascular risk factors in     patients with ankylosing spondylitis   "
141154|NCT01436929|"     Tuberculosis is a worldwide common infectious disease and effective first line     anti-tuberculosis (TB) drugs were available such as isoniazid, rifampicin, ethambutol, and     pyrazinamide. However, anti-TB drugs may induce hepatic injury resulting in discontinuation     of anti-TB drugs or changing anti-Tb drug regimen.      Silymarin has been widely studied for the effect on hepatitis and it has been used in     hepatology.      Therefore, the investigators hypothesized that prophylactic administration of silymarin with     anti-TB drugs may decrease the incidence and severity of hepatotoxicity induced by anti-TB     drugs.   "
141169|NCT01436734|"     The aim of the study was to investigate the role of the Trasylol in glucagon prevention in     degradation using radioimmunoactive method with I125. Additionally different incubation time     was introduced in human plasma samples after oral glucose stimulation, also in fasted and     hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the     techniques for the glucagon measurement are well described nowadays.   "
141157|NCT01436890|"     Asthma is a common, chronic inflammatory disease of the bronchial airways, with a reported     prevalence in most industrialized countries of between 5 to 10 % of the adult population.     Asthma is clinically characterized by repeated episodes of wheezing, breathlessness, chest     tightness, and coughing; usually in the presence of variable airflow obstruction that is     often reversible either spontaneously or with treatment (The Global Initiative for Asthma     (GINA), 2009).      Drug treatment of asthma has focused on anti-inflammatory therapy in all but the mildest,     intermittent cases. Inhaled corticosteroids have been shown to be anti-inflammatory in     asthma, but chronic use of these agents may be associated with a range of side effects,     especially at high doses. In asthma, there remains a need for the development of novel     anti-inflammatory therapies that are at least equally effective and possess a superior safety     profile in comparison to corticosteroids.      This is a randomized, double-blind, triple dummy, placebo controlled, parallel group, dose     ranging study. The study will be conducted in adult patients with a diagnosis of chronic     persistent asthma with an Forced Expiratory Volume in one second(FEV1) of 50% to 80% of the     predicted value. Study will enroll 448 patients globally (278 from India) across different     centers.      Patients will be recruited after providing written informed consent. After screening and run     in period, patient will be randomized (patient meeting randomization criteria) in 1:1:1:1     ratio to receive either one of the three dose regimens of revamilast or placebo.      The primary objective of the study is to evaluate the effect of revamilast on lung function     as assessed by Forced Expiratory Volume in one second (FEV1) after the therapy (12 weeks).     Secondary objective includes area under curve for FEV1, Change in asthma symptoms, patient /     investigator's global assessments and safety. Patients will be followed for safety and     efficacy assessment at week 1, 4, 8 12 and 14 after start of therapy.   "
141158|NCT01436877|"     The purpose of this study is to assess the safety and efficacy of MediTate Temporary     Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction     (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck     and prostatic urethra under local anesthesia for few days and taken out some 5 days later in     the doctors office.   "
141159|NCT01436864|"     This study is designed to prove and confirm the efficacy and safety of multiple injections of     human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in     patients with choroidal neovascularization due to neovascular age-related macular     degeneration by comparing intravitreal injections of KH902 with sham-injections.   "
141160|NCT01436851|"     In a previous study the investigators found that many bakery workers were sensitized to     storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational     allergen with clinical relevance has been questioned, and the investigators wanted to     investigate whether a nasal provocation with a storage mite extract would trigger symptoms     and objective signs of rhinitis in bakery workers and a control group.   "
141161|NCT01436838|"     Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy     thereby involving safety risks for the patient and influencing health cost-effectiveness.     This observational study will concentrate upon the role of MS nurses in influencing     adherence. This study will examine the influence of initial and subsequent periodic nurse     interviews which aim to improve adherence to Betaferon® treatment.   "
141162|NCT01436825|"     OPTIMS is a non interventional validation study of the calculator developed by Bayer for     clinician's use in the prophylactic treatment by factor VIII of patients with severe or     moderate Haemophilia A with a severe clinical profile.      The study takes place during a single visit, at the time of patient enrollment in the study   "
141163|NCT01436812|"     The investigators hypothesized that positive end expiratory pressure (PEEP) would increase     the regional oxygen saturation (rSO2).   "
141164|NCT01436799|"     The investigators hypothesized that both propofol and desflurane would decrease the regional     oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when     patients are raised to the sitting position.   "
141165|NCT01436786|"     Demonstrating the effectiveness of an economical and feasible intervention such as guided     imagery on factors associated with preterm birth, along with better understanding of pathways     leading to adverse birth outcomes has tremendous health, social, and financial benefits. This     project has the potential to significantly advance the field of nursing and knowledge     development in the areas of maternal stress reduction in African American women and to     provide scientific evidence of the effectiveness of guided imagery.   "
141166|NCT01436773|"     Adventitial vasa vasorum (VV) as well as intraplaque microvessels are known to be associated     with atherosclerotic plaque vulnerability. Contrast-enhanced ultrasound has been validated as     a technique to measure the density of VV. Previous studies have demonstrated a relationship     between identification of VV and relationship to vascular events such as stroke and     myocardial infarction. No previous study has reported the utilization of contrast-enhanced     ultrasound identification of VV in the carotid bed as a means of identifying patients at high     risk for acute coronary events.      Aims: In this study, the investigators will aim to identify VV and intraplaque microvessels     along with carotid intima media thickness (CIMT), a known marker for acute coronary events.     The investigators will attempt to measure the correlation of VV with acute coronary events     independent of traditional cardiovascular disease (CVD) risk factors and CIMT.      Methods: 90 volunteers (30 low risk patients, 30 patients with established coronary artery     disease (CAD), and 30 patients with recent acute coronary syndrome (ACS)) will be enrolled.     All patients will undergo contrast-enhanced ultrasound imaging of their carotid arteries and     measurement of CIMT while obtaining baseline histories and assessment of traditional risk     factors for coronary artery disease. VV density and CIMT will be measured in all patients.     Statistical differences in VV among the three groups will be assessed and analyses will be     made to attempt to identify if VV in the carotid bed is an independent predictor of acute     coronary events after controlling for CIMT and traditional risk factors.      Study population: The study population will reflect the patient population of UPMC. No     individual will be excluded on the basis of race, gender, or ethnicity.   "
141167|NCT01436760|"     The goal of the study is to identify possible polymorphisms on the loci of candidate genes     that may be involved in modulation of pain and inflammation in irritable bowel syndrome.   "
141168|NCT01436747|"     The study 'Safety and Efficacy of Paricalcitol for Reduction of Proteinuria in Kidney     Transplant Recipients' is designed to assess the effects of paricalcitol in kidney transplant     recipients with proteinuria.      It is a single centre, randomized, placebo-controlled, double-blind clinical trial that tests     the hypothesis that 24 weeks' treatment with paricalcitol compared to placebo will result in     a decrease in urinary protein excretion in recipients of a kidney transplant at least three     months after transplantation. Additionally, the effects of paricalcitol on albuminuria,     estimated glomerular filtration rate, and blood pressure will be investigated.   "
141170|NCT01436721|"     Hepatectomy is one of the best treatments for malignant or benign lesions of the liver. The     mortality and morbidity rates after hepatectomy have declined in recent years because of the     precise measurement of liver functional reserve, a better understanding of liver anatomy,     meticulous haemostasis during operation and improved postoperative management. Although     surgical techniques have improved, life-threatening complications, such as intra-abdominal     bleeding, bile leakage and subphrenic infection, now cannot be completed avoided. The local     complications were most associated with the liver section treatment during the operation.     Hence, the need for safer and more effective hemostatic treatment than the conventional     approaches, such as intraoperative pressure by surgical gauze, ligatures, and     electrocoagulation by mono- or bipolar instruments.      Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the     controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood,     it swells into a brownish or black gelatinous mass which aids in the formation of a clot,     thereby serving as a haemostatic adjunct in the control of local haemorrhage barriers on     section.      The present randomized clinical trial was designed to evaluate the efficacy and safety of     Surgicel® absorbable Haemostat covering the raw cut surface during the hepatectomy.   "
141171|NCT01436708|"     Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction,     and analyzing the association will be helpful to identify the indication of proper     management. Therefore, the aim of this study is to identify the above associations.   "
141172|NCT01436695|"     Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly     unpredictable spontaneous seizures. The occurrence of the seizure in patients without any     forewarning is the most debilitating aspect of the disease.      The Epicall system is intended for early detection of seizure related life threatening events     by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of     the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG     (photoplethysmograph electrode) sensors for continuous monitoring of:        1. Heart Rate (base line, increase, decrease, asystole).        2. Extra ocular eye movement (blinking, eye deviation, roving eye movements).   "
141173|NCT01436682|"     The study investigates assisted nerve blocks using an ultrasound machine.   "
141174|NCT01436656|"     CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose     (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily     and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic     melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase)     and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the     expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts     of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion     part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.   "
141175|NCT01436643|"     This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple     Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin     reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI)     antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate     the safety and tolerability of this combination in this patient population based on an     immunomodulatory treatment with fingolimod.   "
141176|NCT01436630|"     The purpose of this study is to investigate the viability of using the Step Test (ST) in     stroke patients, and to compare the functional performance of the physiologic variables in     stroke patients during ST and Six Minute Walk Test (6MWT).   "
141181|NCT01436565|"     Primary Objective:        -  To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of          SAR245408 administered in combination with SAR256212 in adult patients with locally          advanced or metastatic solid tumors.      Secondary Objectives:        -  To characterize the global safety profile of SAR245408 in combination with SAR256212        -  To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in          combination        -  To evaluate the objective response rate (ORR) and tumor volume change (for expansion          cohort only)        -  To determine the immunogenicity of SAR256212 as administered with SAR245408   "
141182|NCT01436552|"     Background: Dementias (Alzheimer's disease and related syndromes), in their sporadic form,     have multifactorial origin. Several risk factors (RF) are currently recognized like the     cardiovascular RF, some genes of susceptibility, but the impact [1] of traumatic life events     (TLE), considered as psychosocial RF (Persson & Skoog, 1996; Charles et al, 2006), [2] of     anxiety and/or depression, [3] of the premorbid personality (Clément et al, 2003) with his     coping strategies, and [4] of the lifestyle (which results from the personality), for the     moment are still underestimated. Dementia disease can be clinically preceded by a mild     cognitive impairment (MCI) (Petersen et al, 1996) which is however potentially reversible.      Purpose: Actually, there is no study concerning the rate of conversion from MCI to dementia     according to the presence or not of TLE. The aim of this study is to assess association     between TLE and conversion rate from MCI to dementia.      Methods: Patients with MCI will be recruited in different memory clinics (Limoges and others)     Primary outcome: Occurrence of dementia according to DSM-IV-TR criteria in MCI patients     according to their cumulated score of TLE measured by EVVIE.      Secondary outcomes: Occurrence of dementia in MCI patients according to various other     psychopathological factors: anxiety, depression, apathy, personality features, alexithymia     and resilience levels and life style.      Study design: Epidemiologic cohort longitudinal and prospective multicenter study.   "
141183|NCT01436539|"     The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus     polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic     hepatitis B.   "
141225|NCT01435980|"     Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type     2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass     and Exenatide.   "
141226|NCT01435967|"     The aim of this study is to monitor any impact in the change from the lyophilised formulation     to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus     gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due     to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and     after introduction of the liquid formulation of the vaccine in Belgium.   "
141184|NCT01436526|"     The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant     for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary     embolism (PE) in people undergoing knee or hip replacement surgery.      The purpose of this study is to establish bioequivalence of 2 immediate-release tablet     treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy     volunteers under fasting conditions; they will be administered as single oral doses in 2     periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence     represents the primary study objective. As a secondary objective, this treatment will be     assessed in terms of safety and tolerability.      Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood     samples of the volunteers will be taken at specific points in time; these samples will be     analyzed using various statistical methods to establish pharmacokinetic characteristics     required to compare the 2 treatments. The planned treatments with Rivaroxaban will be     considered bioequivalent if specific criteria defined in the study protocol are met.      The study will be conducted in one center in Germany. 28 subjects meeting the inclusion     criteria will participate. They will be treated according to a single-dose, randomized, 2-way     cross-over, non-placebo-controlled design.   "
141185|NCT01436513|"     The purpose of this study is to assess the bioequivalence and food effect for a new Premarin     formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal     women.   "
141186|NCT01436500|"     A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult     patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.   "
141187|NCT01436487|"     A study to examine the safety and potential effectiveness of the adult stem cell     investigational product, MultiStem, in adults who have suffered an ischemic stroke. The     hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.   "
141188|NCT01436474|"     The objective of this proposal is to explore the potential of varenicline as a     pharmacotherapeutic agent for opioid dependence and addiction.   "
141189|NCT01436448|"     Introduction: The overall aim of the study is to assess the efficacy of Lactobacillus     Rhamnosus in reducing glucose intolerance during and after pregnancy. A second objective of     the study is to determine the feasibility, compliance and safety of Lactobacillus Rhamnosus     among this cohort. Within this goal is to determine whether the investigators can enroll     women at high risk for developing Gestational Diabetes Mellitus (GDM) and follow them out at     regular antenatal visits and 6-weeks post partum.      Women with GDM are, 7 times more at risk of developing type 2 diabetes compared with those     who had a normo- glycaemic pregnancy. The population attributable risk for type 2 diabetes     mellitus (DM) in women with GDM is high, and around 30 - 50% women with GDM converts into     type 2 (DM) which is associated with pre-mature morbidity, mortality and high economic     burden. It is evident that untreated GDM is associated with higher incidence of complications     during pregnancy and increases the risk of perinatal mortality and infant morbidity. The     prevalence of GDM in Pakistan is around 8%, comparatively higher than other South Asian     countries. Therefore, interventions that can improve glucose regulation during pregnancy are     highly important.      Probiotics, the live micro-organisms, have shown promising results in regulating glucose     metabolism among pregnant mice. The effect of Probiotics on glucose metabolism is     attributable to their immuno-regulatory properties. They elicit powerful anti-inflammatory     capabilities by inhibiting the NF-kB pathway, which mediates microbial activation of the     immune system. Further, they diminish both fermentation of polysaccharides and induction of     fasting-induced adipocyte factor gene transcription. The safety of Lactobacillus Rhamnosus     among pregnant women is already established in other diseases.      A placebo controlled trial from Finland on pregnant females randomized to receive either     dietary counseling and Probiotics (Lactobacillus Rhamnosus), concluded improved glucose     tolerance as compared to the placebo group [OR 0.31 (95% CI 0.12, 0.78)]. However, this study     could not determine the sole effects of probiotics in reducing glucose intolerance.     Nevertheless, no studies on the role of Lactobacillus Rhamnosus in regulating glucose     intolerance have been conducted in any other part of the world yet. Therefore, a pilot trial     to see the efficacy, compliance and feasibility of Lactobacillus Rhamnosus among pregnant     females is imperative. The objectives of the investigators study are:        -  To assess the efficacy of Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units          (CFU)/day) in reducing glucose intolerance among pregnant women attending antenatal          clinic of Karachi-Pakistan.        -  To assess the feasibility, compliance and safety of conducting a double blind, placebo          controlled randomized trial of Lactobacillus Rhamnosus by recruiting high risk women          during pregnancy attending antenatal clinics and following them up 6 weeks postpartum in          Karachi-Pakistan.      Methods: For the pilot trial, women will be recruited from antenatal hospital of the city,     during 12-14 weeks of gestation.      Study Design: The study will be double blind randomized, placebo controlled trial.     Randomization will be done by blocked method. The dose of 1010 Colony forming Units (CFU)     once daily till delivery will be given orally.      Study Endpoints and Ascertainment: Baseline information will be comprised of socioeconomic     status, parity, gravida, blood pressure and obstetric history etc. The study endpoint     comprises of efficacy, feasibility, compliance and safety and will be ascertained at monthly     follow-up, during week 24 - 28, and 6 weeks post partum. Efficacy will be ascertained by Oral     Glucose Tolerance Test (OGTT) performed at randomization and during 24-28 weeks of gestation.     Feasibility and compliance will be assessed through recruitment rate, drop-out rate, reasons     for drop-out, non-participation and empty drug sachet count.   "
141190|NCT01436435|"     The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on     various lesions types/morphologies.   "
141191|NCT01436422|"     Dengue viruses can cause dengue fever and other serious health conditions, primarily     affecting people living in tropical regions of the world. This study will evaluate the safety     and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy     adults.   "
141192|NCT01436409|"     The main objective of this study is to compare the rate of fetal extractions between a     systematic practice of an echography of presentation and the vaginal touch only one usually     realized during the labor.   "
141193|NCT01436396|"     The study is designed to evaluate whether the first CYD dengue vaccination can be     administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit,     but at 2 different sites of administration.      Primary Objective:        -  To demonstrate the non-inferiority of the immune response against Yellow Fever in          flavivirus (FV)-naïve subjects at baseline receiving one dose of Stamaril vaccine          administered concomitantly with the first dose of CYD dengue vaccine compared to          subjects receiving one dose of Stamaril vaccine concomitantly with placebo.      Secondary Objectives:        -  To assess the non-inferiority of yellow fever immune response 28 days post-Stamaril          vaccination based on seroconversion rates regardless of the FV status of subjects at          baseline.        -  To describe the safety of Stamaril vaccine administered concomitantly with the first          dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.        -  To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine          administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.   "
141194|NCT01436383|"     The trial investigates changes in metabolism during high altitude expedition up to 6865m. A     mass-spectrometry based platform is used to detect different oxidative stress related     metabolites. Symptoms of acute mountain sickness are evaluated and correlated with laboratory     parameters.   "
141195|NCT01436370|"     A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving     TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched     control subjects . This study will investigate the immunogenicity, safety, and reactogenicity     of two different doses of inactivated trivalent influenza virus vaccine (Sanofi Pasteur     Fluzone [15 mcg x 3 strains] and Sanofi Pasteur Fluzone High Dose [60 mcg x 3 strains])     administered intramuscularly in individuals with rheumatoid arthritis receiving     anti-TNF-alpha (TNFi) therapy and healthy age- and gender- matched controls.   "
141196|NCT01436357|"     A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C     virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45. AdCh3NSmut1     and MVA-NSMut HCV vaccine will be administered to 68 (+/-4) volunteers in stage 1. A planned     interim analysis of safety and immunogenicity will be conducted. If no safety signal is     detected and there is evidence of a measurable immune response to HCV then 472 (+/-4)     volunteers will be enrolled in stage 2. Primary objectives are to 1) assess the safety of     AdCh3NSmut1 and MVA-NSmut compared to placebo when administered to HCV-uninfected IDUs and 2)     determine if AdCh3NSmut1 and MVA-NSmut HCV vaccines will reduce incidence of chronic HCV     infection compared to placebo among HCV-uninfected IDUs. Planned study duration is approx 63     months (accrual time, 2 months vaccination, 18 months follow-up, and 9 months extended     observation for subjects becoming viremic in the last month of follow-up).   "
141197|NCT01436344|"     With the use of esophageal Holter electrocardiography (eECG), the investigators will look for     surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will record     eECGs in patients with known paroxysmal atrial fibrillation but at the time of eECG-recording     in sinus rhythm. To identify markers, the eECGs of those patients will be compared to a group     of controls in sinus rhythm without atrial fibrillation. The investigators hypothesis is that     it is possible to identify surrogate markers in patients with paroxysmal atrial fibrillation.   "
141352|NCT01434316|"     This phase I trial studies the side effects and the best dose of veliparib and dinaciclib in     treating patients with solid tumors that have spread to other places in the body and usually     cannot be cured or controlled with treatment. Veliparib and dinaciclib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
141198|NCT01436331|"     Multi-element interventions for first-episode psychosis (FEP) are promising but have mostly     been conducted on non epidemiologically representative samples in experimental settings,     raising the risk thereby of underestimating the complexities involved in treating onset     psychosis in real world services. The PIANO Trial (Psychosis early Intervention and     Assessment of Needs and Outcome) is part of a more broad-based research program (Genetics,     Endophenotype and Treatment: Understanding early Psychosis - GET UP) and aims to: 1) test, at     9 months, the effectiveness, as compared to treatment as usual (TAU) of multi-component     psychosocial intervention on a large epidemiologically-based cohort of FEP patients and their     family members recruited from a 10 million inhabitant catchment area; 2) identify barriers     that may hinder its feasibility and patient/family conditions that can render this type of     treatment ineffective or inappropriate; 3) identify clinical, psychological, and     environmental and service predictors of treatment effectiveness in FEP.      Study participants will be recruited from Community Mental Health Centers (CMHCs) operating     for the Italian National Health Service and located in several Northern and Central Regions     of Italy. The GET UP PIANO Trial has a pragmatic cluster randomized controlled design, which     is considered the gold standard approach for trials that evaluate complex interventions     implemented at the institutional level, with the aim of improving health. The assignment     units (clusters) are the CMHCs, and the units of observation and analysis are the Centers'     patients and their family members.      Patients in the experimental group will receive TAU plus: (a) Cognitive-Behavioural Therapy     (CBT) sessions, (b) psycho-educational sessions for family members, and c) a case manager, to     serve as the patient's referent. Patient enrollment will take place over a 1 year interval,     after a 3 month-long piloting. The fidelity of the experimental interventions and the     characteristics of TAU will be regularly monitored. Several psychopathological,     psychological, functioning and service use variables will be assessed at baseline and 9 month     follow-up by independent evaluators. Assuming an expected incidence rate of 17/100.000 per     year for functional psychoses (as previously estimated in Italy), the investigators expect to     recruit about 800 patients, and 600 relatives. Assuming an attrition rate of about 50%, the     size of the trial would detect at 9 months a difference in terms of primary outcome from 25%     for the TAU arm to 10% for the intervention arm, with a power of 80%.   "
141199|NCT01436318|"     Respiratory muscle strength training (RMST) is a potential treatment option that has been     shown to increase strength and ventilatory function in critically ill patients, patients on     ventilators and patients with mild neuromuscular weakness. Currently researchers are     examining the role of inspiratory muscle strength training (IMST) in pressure performance of     ventilator dependent children with Pompe disease. However, normal pressure-flow-timing     responses of lung function are not well-characterized in healthy children. The purpose of     this study is to measure RMST-induced changes in respiratory function in healthy children.     Children will undergo one session of lung function and strength testing. By studying healthy     children's respiratory function, this study will also help to develop more efficient     respiratory muscle training exercise prescriptions for children with neuromuscular weakness     and impaired respiratory function.   "
141200|NCT01436305|"     The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would     minimize serious long term side effects associated with anti-rejection medications while     still protecting the new kidney from damage. The researchers also wanted to learn more about     the safety of this treatment and long term health of the transplanted kidney.   "
141201|NCT01436292|"     The purpose of this study is to determine whether 5% human albumin solution, given to correct     hypoalbuminemia, could improve organ dysfunction in burn patients as assessed by a change in     the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or     died).   "
141202|NCT01436279|"     In this study the investigators plan to compare mifepristone and misoprostol use to osmotic     dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be     given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2     hours prior to abortion. Osmotic dilators are the method currently used in our institution,     and are placed 24 hours prior to abortion. The primary outcome will be the length of the     procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure,     participant's assessment of discomfort before mifepristone or dilators, discomfort during the     abortion procedure, acceptability to participants, and acceptability to staff.   "
141203|NCT01436266|"     Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to     aid in softening the cervix as well as decreasing blood loss after abortion or vaginal     delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in     decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled     trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester     surgical abortion decreases blood loss from the procedure. The investigators will also assess     whether misoprostol improves cervical dilation, changes the length of the procedure, changes     the need for additional mechanical dilation, changes the subjective ease of the procedure,     and changes a woman's pain.   "
141206|NCT01436227|"     The goal of this clinical research study is to learn if pazopanib can help to control VHL.     The safety of this drug will also be studied.      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for     tumor growth. This may prevent or slow the growth of cancer cells.   "
141207|NCT01436214|"     This study is a phase 1/2a, open label, dose escalation and safety study of APC-100     (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.   "
141208|NCT01436201|"     The purpose of this study is to study how the body processes digoxin and the effect of     dulaglutide on how digoxin is processed by the body. Information about any side effects that     may occur will also be collected.      This study is for research purposes only and is not intended to treat any medical condition.     This research study requires that a blood sample be obtained and stored for future research     involving genetic analysis.   "
141209|NCT01436188|"     The purpose of this study is to investigate changes of cerebral spinal fluid (CSF) proteins     over time using continuous CSF sampling for 36 hours in elderly healthy volunteers and     volunteers with mild cognitive impairment or Alzheimer's Disease.   "
141210|NCT01436175|"     This study is an optional continuation of previous short-term adult major depressive disorder     (MDD) augmentation studies. Patients may only take part in this long-term, open-label     research study if they completed a previous double-blind MDD augmentation study using SPD489.   "
141240|NCT01435785|"     Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients,     pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively     assessed in this population. The aims of this study are to derive four PKPD models using     previously published PK parameters sets, and to prospectively assess their performance in     elderly people. With the obtained data we propose to build a specific PKPD model for this     population.   "
141241|NCT01435772|"     This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion     every 2 weeks (qow) to patients with late-onset Pompe disease.   "
141211|NCT01436162|"     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)     who are taking certain types of antidepressants but continue to have residual depression     symptoms. Eligible patients will remain on their antidepressant but will be randomized to     either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is     to help answer the following questions:        -  How safe is SPD489 for the supplemental treatment of depression and what are the side          effects that might be related to it?        -  Can supplemental SPD489 help patients who still have residual depression symptoms while          taking an antidepressant?        -  How much SPD489 should be given to patients with depression who are also taking an          antidepressant?        -  How does SPD489 compare to placebo in depressed patients who are also taking an          antidepressant?   "
141212|NCT01436149|"     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)     who are taking certain types of antidepressants but continue to have residual depression     symptoms. Eligible patients will remain on their antidepressant but will be randomized to     either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is     to help answer the following questions:        -  How safe is SPD489 for the supplemental treatment of depression and what are the side          effects that might be related to it?        -  Can supplemental SPD489 help patients who still have residual depression symptoms while          taking an antidepressant?        -  How much SPD489 should be given to patients with depression who are also taking an          antidepressant?        -  How does SPD489 compare to placebo in depressed patients who are also taking an          antidepressant?   "
141213|NCT01436136|"     This is a cohort study which follows two groups of participants over a 12 months period. One     group will access a team approach to care with the aim of reducing their cardiovascular     disease (CVD) risks from a team of doctors, nurses and health care professionals. The other     group will continue to access standard care from their treating doctor. Both groups will have     CVD risk score evaluated after a 12 month period.      The team care approach will involve specific tests to measure CVD risk as well as smoking     cessation, exercise and dietary advice and support, including monitoring such as blood     pressure and cholesterol levels   "
141214|NCT01436123|"     Intensive therapy with rosuvastatin 40 mg and ApoA-I Milano reduces the total atheroma volume     (TAV) up to 6.38 or 14.1 mm3 respectively. Our previous bench studies PLASMONICS and NANOM     First-in-Man trial documented TAV reduction up to unprecedented 79.4 and 60.3 mm3     respectively with high level of safety and feasibility.      The completed randomized two arm (1:1) study (NANOM-PCI) with parallel assignment (n=62)     assessed (NCT01436123) the safety and feasibility of the delivery technique for nanoparticles     (NP) using micro-injection catheter (with intravascular intramural injection of allogeneous     stem cells carrying NP after MSCT-, IVUS- and OCT-guided mapping of the vessel), and     plasmonic photothermal therapy of atherosclerosis combined with stenting (Nano group, n=32)     versus stenting with Xience V cage (Stenting group, n=30). The primary outcome was TAV at 12     months.      The mean reduction of TAV at 12 months in Nano group was -84.1 mm3 (95% CI: SD 28.3; min     -52.4 mm3, max -99.1 mm3; p<0.05) versus +12.4 mm3 in case of stenting (p<0.05 between     groups). 42/62 patients (68%) in Nano group passed the Glagov threshold of a 40% plaque     burden with mean plaque burden (PB) 36.2% (95% CI: SD 9.3%, min 30.9%, max 44.5%). The     increase of the minimal lumen diameter was 61.2 and 63.3% at 12 month follow up in groups     respectively. The serial assessment of VH-IVUS showed a significant decrease at 12 months in     the dense calcium area, fibrous and fibro-fatty tissue with fulminant necrosis due to     thermolysis in Nano-group, whereas an increase of fibrous and fibro-fatty components in     stenting arm. We have documented 2 vs 3 cases of the definite thrombosis and 3 vs 5 cases of     target lesion revascularization in groups respectively. The analysis of the event-free     survival of the ongoing clinical follow-up shows the significantly lower risk of     cardiovascular death in Nano group if compare with conventional stenting (93.4% vs 86.7%;     p<0.05).      Plasmonic resonance-mediated therapy using noble-metal NP associated with significant     regression of coronary atherosclerosis. Tested delivery approach has acceptable safety and     efficacy for atheroregression below a 40% PB.      The investigators hypothesize that multistep approach with the use of stent in acute care     unit, and then subsequent transcatheter micro-injection with nanoparticles can resolve     atherosclerosis, stop and regress atherogenesis, remodulate or even rejuvenate arteries. Stem     cells in patch can be good carriers for nanoparticles as well as high-effective metabolic     vectors (paracrine-like regulation of alive cells and via bioactive products of cell lysis     after detonation of nanoparticles) for the treatment of plaque on site. Gold nanoparticles     with silica-iron oxide shells promise high-energy plasmonic photothermic burning or melting     effect under the near-infrared laser irradiation onto the lesion. Thus the investigators     expect complex two-side effect on the plaque with protected lumen and adventitia.      Novel discoveries in atherogenesis, and development of nanobiotechnologies with potentials     for the management of atherosclerosis leads us to the quest of new approaches. The     investigators still cannot really effectively treat atherosclerosis.      The investigators management is more symptomatic, and lipid-pool or inflammation-oriented!     The investigators cannot manage non-organic part (mineral deposits, calcified necrotic core,     partially collagen and fibrotic tissue) and total plaque volume Surgery and invasive     procedures is just focused on blood flow restoration (just manipulate the form of plaque) +     concerns of clinical and technical restrictions (incl. alien body - stent) + risk of     restenosis or subacute 'fatal' in-stent atherothrombosis + graft survival/ occlusion +     surgery-related complications High rate of short- and long-term complications and     readmissions. Regression of atherosclerosis in fact is still a dream. The investigators offer     an alternative to stenting and may be cardiac artery bypass surgery (CABG). Our approach can     really allow to rejuvenate arteries, Plasmonic photothermal therapy (PPTT) can burn plaque,     but stem cells and bioengineered structures promise restoration of the vessel wall.      Our personal previous data showed that PPTT can 1.6-fold reduce a volume of plaque with most     optimal long-term result in subsets with the use of SPCs as a delivery approach. The most     optimal delivery systems of NPs into the plaque are the on-artery bioengineered patch and     ferro-magnetic approach.   "
141215|NCT01436110|"     A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate     the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate     inhalation powder in the treatment of asthma in adults and adolescents not currently treated     with inhaled corticosteroids   "
141216|NCT01436097|"     Interventions to increase the consumption of fruits and vegetables to date have shown     promise, but many have limited public health impact due to the lack of scalability of their     designs. The investigators propose to examine the effectiveness and feasibility of an     intervention for promoting increased consumption of fruits and vegetables by incentivizing     their purchase. Collaborating with UpLift Solutions, the investigators will enroll shoppers     in this Randomized Clinical Trial using the research infrastructure called the Way to Health     platform. (called the Way to Health platform, and approved as a Prime protocol by the IRB as     reference # 811860).      Hypothesis: providing patients with financial incentives can promote healthier behaviors     (e.g.: eating healthier).   "
141217|NCT01436084|"     The goal of this clinical research study is to learn if SB1518 can help to control     myelodysplastic syndrome. The safety of the drug will also be studied.      SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain     leukemias, myelofibrosis, and lymphoma.   "
141218|NCT01436071|"     A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study     to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of     persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids   "
141219|NCT01436058|"     Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage     in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain     and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first.     If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic     options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells     have showed the capacity of bone and cartilage regeneration.   "
141220|NCT01436045|"     The purpose of this study is to investigate the effect of the rapidly acting intranasal     insulin derivative (glulisine) on memory and cognition in 12 patients suffering from     mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose     study. This study will further assess safety of insulin glulisine as well as the effects of     this drug on olfaction.   "
141221|NCT01436032|"     The purpose of this study is to determine the analgesic efficacy and safety of N1539 in     subjects undergoing abdominal laparoscopic surgery.   "
141222|NCT01436019|"     The purpose of this study is to analyze the frequency of the formation of antibodies against     three different anti-TNF biologic agents used for the therapy of juvenile idiopathic     arthritis.   "
141223|NCT01436006|"     The situation in Italy regarding radiation dose to patients undergoing Multidetector row     Computed Tomography (MDCT) scans is unclear despite Italian law require that each centre     check the Reference Dose Level (RDL) every two years. RDL in CT were first suggested in a     document of 1998 published by the European Commission (EUR16262/1998) based on the results of     an older survey in the UK from the late 1980s. Those RDLs, expressed in terms of Computed     Tomography Dose Index (CTDI) and Dose Length Product (DLP), are reported in the Italian law     (D.Lgs.187/00). However, in Italy there is no governmental authority comparable to the UK's     National Radiological Protection Board, deputed to dose evaluation and protection.      An overview of the Italian situation is relevant in order to know the actual dose levels for     MDCT administered to patients both adults and paediatrics.   "
141224|NCT01435993|"     This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with     relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital     signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of     health from blood samples), tolerability (any side effects that occur, if any), and     pharmacokinetics (how the body processes the drug and how long the drug stays in the blood,     and in cerebro-spinal fluid). The study will also investigate if patients' own immune system     interacts with GSK1223249.   "
141227|NCT01435954|"     In patients with benign prostatic hyperplasia (BPH), combination therapy with an     alpha-blocker (AB) and a 5 alpha-reductase inhibitor (5ARI) has been shown to reduce the     progression of acute urinary retention (AUR) and the incidence of prostate surgery, and also     provides symptom relief.      The objective of this study is to compare the likelihood of clinical progression (defined as     AUR and/or prostate-related surgery) and costs in BPH patients who were treated with delayed     combination therapy to BPH patients who were treated with early combination therapy using     data from a United States (US) healthcare claims database. The hypothesis of this study is     that patients who are prescribed combination therapy early in their BPH treatment will     experience better clinical outcomes and lower healthcare costs compared with patients treated     with delayed combination therapy. The null hypothesis is that no difference will be observed     in outcomes or direct medical costs for patients treated with early combination therapy and     patients treated with delayed combination therapy.      The US healthcare claims database includes data from patients with Medicare Advantage as well     as private health plan coverage including the Impact health plan. About 14 million people     were covered by this set of health plans in 2007 and were geographically diverse across the     US. Data from 2000 through 2009 were utilized.      The study is a retrospective cohort analysis.   "
141228|NCT01435941|"     Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary     headache care and is associated with a number of deleterious outcomes, especially higher     disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined     as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that     increase or decrease the risk of developing CM. One factor that appears especially relevant     is symptomatic medication use. The current study builds upon and expands previous work     considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has     on the likelihood of developing CM.      This study is a retrospective observational cohort study of data collected via mail survey     and collated in the American Migraine Prevalence and Prevention (AMPP) database.      Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a     longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States     (US) households were screened and 24,000 individuals who reported severe headaches were     identified and additional questionnaires have been administered annually. This analysis uses     data from respondents who meet second edition of the International Headache Classification-2     (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is     defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month.   "
141229|NCT01435928|"     Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This     clinical study is designed to test the hypothesis that Lurasidone is effective in the long     term maintenance treatment of schizophrenia.   "
141230|NCT01435915|"     The purpose of this study is to investigate the pharmacokinetic profile of ropinirole PR     after single and multiple doses of the PR-formulation. It will also investigate the safety     and tolerability of ropinirole PR after single and multiple doses of PR-formulation.   "
141231|NCT01435902|"     The primary objective of this study is to demonstrate that the combination of inhaled     fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection     throughout the day against bronchoconstriction induced by exercise compared with fluticasone     propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with     persistent asthma.   "
141232|NCT01435889|"     The purpose of this study is to assess long term (1 year) respiratory sequelae in children     surviving an acute respiratory distress syndrome   "
141233|NCT01435876|"     This trial aims to determine which treatment modality is better for treatment of the     convergence insufficiency subtype of intermittent exotropia.   "
141234|NCT01435863|"     The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in     Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).   "
141235|NCT01435850|"     Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL     PLUS (study group).      We compare primary and secondary stability of both hip stems for radiographic outcome using     EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.      Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip     score and radiographic findings.   "
141236|NCT01435837|"     The purpose of the study, Effects of Interaction of Caffeine and Hydration on Voice     Performance, is to gather information about the effects of caffeine and hydration upon voice     performance. The research question involves whether systemic hydration may reduce degradation     on voice performance caused by caffeine ingestion. It is hypothesized that the hydration     conditions will result in a less degraded vocal performance as compared with the nonhydration     condition.The investigation involves abstention from any caffeine ingestion for 24 hours -     from 8pm the day before testing to 8am the morning of testing. In addition, preparation for     participation involves abstaining from ingesting any foods and liquids for 12 hours - from     8pm to 8am of the following morning. Each test will take about 10 minutes.   "
141237|NCT01435824|"     The investigators propose to study amoxicillin absorption in a 2-stage program that will     progressively produce, for the first time, information leading to pediatric pharmacology     recommendations for the administration to children of amoxicillin dissolved in human milk.     The investigators study will enroll adult volunteers as number of blood extractions, volume     of blood required and subject availability, among other issues, generate a number of ethical     and logistical constraints that make it almost impossible to carry such an intensive sampling     study in infants.   "
141238|NCT01435811|"     The purpose of this study is to determine a suitable dose of the human norovirus GII.4     challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible     subjects that would be useful for evaluation of vaccines and antivirals.   "
141239|NCT01435798|"     This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a     larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral     (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord     injury. Subjects' maximally tolerated doses (MTD) were first determined to establish     individual dose-analgesic response relationships in a run-in period; following a washout     period, subjects were then randomized to receive an order of four doses of dextromethorphan     (including placebo) in a 4x4 Latin square cross-over design.   "
141242|NCT01435759|"     This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)     who are taking certain types of antidepressants but continue to have residual depression     symptoms. The purpose of this study is to help answer the following questions:        -  How safe is SPD489 for the supplemental treatment of depression and what are the side          effects that might be related to it?        -  Can SPD489 help patients with depression who are also taking an antidepressant?        -  How much SPD489 should be given to patients with depression who are also taking an          antidepressant?        -  How does SPD489 compare to placebo in depressed patients who are also taking an          antidepressant?   "
141243|NCT01435746|"     The objective of this trial is to evaluate different transfusion strategies in patients after     liver transplantation. Patients in the experimental arm will be given red blood cell (RBC)     transfusion according to a liberal strategy, i. e., transfusions should be given, when     hemoglobin concentration falls below 10 g/dl, and hemoglobin concentration should be     maintained between 10 and 12 g/dl. Patients in the control arm will be given red blood cell     (RBC) transfusion according to a restrictive strategy, i. e., transfusions should be given,     when hemoglobin concentration falls below 8 g/dl, and hemoglobin concentration should be     maintained between 8 and 10 g/dl.   "
141244|NCT01435733|"     The purpose of this study is to investigate whether the presence of a child with Autism     Spectrum Disorder places parents at increased risk for divorce.   "
141245|NCT01435720|"     The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or     refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by     intravenous infusion at various doses.   "
141246|NCT01435707|"     There has been no reports of the effect of various kinds of steroid or various dose of     steroid which are commonly used in the clinical setting. Previous studies have simply shown     that the blood glucose level is elevated in diabetes patients and did not show or suggest the     adequate strategy of epidural steroid injection in diabetes patients regarding steroid type,     dosage or injection interval. Therefore, the investigators tried to evaluate the effect of     different dosage of triamcinolone, which is a commonly used steroid in epidural steroid     injection, on the blood glucose level.   "
141247|NCT01435694|"     Aims of the study:      This is a randomized-controlled trial to test the effects of robot-assisted gait training on     locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait     impairments. The control group will be treat with conventional physical therapy.      Subjects and methods:      60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.      Informed consent will be obtained. Participants will be randomized to Robot-assisted gait     training (experimental group) or conventional therapy (control group) through a randomization     stratification approach, according to a block randomization of 4.      The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2     sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks     (2 sessions/week), that will focus on gait training.      Primary outcome measures will be both neurophysiological measures (motor unit firing rate     characteristics) and clinical test for gait speed (10m walking test). Secondary outcome     measures will include: clinical tests of walking endurance (six minute walking test), balance     (Berg Balance Test) and mobility (Up and Go Test).      Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue     (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored.     Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale.     Outcome measures will be assessed the week prior to treatment initiation (T0), after 6     sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to     evaluate treatments retention, by a clinician blinded to the treatment.   "
141248|NCT01435681|"     This is a research study using transcranial magnetic stimulation (TMS) to investigate     interactions between the sensory system and the motor cortex in primary generalized dystonia     (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery.      The sensory system is the body's sense organs - smell, sight, sound, etc. - and the motor     cortex is the part of your brain where nerve impulses control voluntary muscle activity.   "
141249|NCT01435668|"     The purpose of this study is to evaluate the effectiveness of a Brief Motivational     Intervention (BMI), in reducing alcohol consumption among patients with hazardous or harmful     drinking admitted in emergency department (ED). Patients aged 16 to 24 and who tested     positive for blood alcohol content (BAC) of 0.5g/l. or above are enrolled.      Patients receive either an information leaflet or an information leaflet plus a referral to a     psychologist. BMI is provided by the psychologist. BMI consists in a first face-to-face     interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are     also invited to attend the BMI session. If necessary, patients can be referred to relevant     care and treatment services for alcohol misuse.      In a simple blind, randomised controlled clinical trial of 280 patients, 140 patients are     allocated to the treatment group and 140 to the control group. Randomisation is stratified     according to patient's age (16-17 or 18-24). Opaque and sealed randomized envelops are used     for randomisation.      Alcohol consumption is measured by self-report at 3 months. The principal criteria used to     assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks     in the last week. Other events such as ED readmission, quarrels related to alcohol, drinking     and driving, sexual intercourse without protection will also be assessed. It is the first     clinical trial in France comparing these two interventions among young patients in ED with     this design.   "
141250|NCT01435655|"     Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.   "
141251|NCT01435642|"     This study is conducted in Africa. The aim of this non-interventional study is to evaluate     the current status of diabetes management, complications and psychosocial aspects for     children with type 1 diabetes in Algeria.   "
141252|NCT01435629|"     This study is conducted in Japan. The aim of the study is to evaluate the efficacy of     somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia /     hypochondroplasia enrolled in the GH-1941 study (NCT01516229).   "
141280|NCT01435265|"     This is a phase IV randomized, prospective open label study to asses the efficacy of an     extended nurse eduction program in improving adherence to the prescribed treatment regimen in     the treatment of moderate to severe psoriasis vulgaris.   "
141253|NCT01435616|"     The purpose of this study is:        -  To compare the blood sugar control on LY2605541 with insulin glargine after 52 weeks of          treatment.        -  To compare the number of night time low blood sugar episodes on LY2605541 with insulin          glargine during 52 weeks of treatment.        -  To compare the number of patients on LY2605541 reaching blood sugar targets without low          blood sugar episodes at night to those taking insulin glargine after 52 weeks of          treatment.        -  To compare the total number of low blood sugar episodes on LY2605541 with insulin          glargine after 52 weeks of treatment   "
141254|NCT01435603|"     The purpose of this study is to compare ways of giving advice and providing support to     improve diet and physical activity in adult primary care patients with elevated body mass     index and dysglycemia.   "
141255|NCT01435590|"     OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to     diagnostic and patient discomfort.      METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be     randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC)     or and endocervical brush. All samples will be submitted for histological study.   "
141256|NCT01435577|"     The purpose of this trial is to established the safety and efficacy of multiple dose     treatment with tapentadol IV in an adult population with moderate to severe pain following     bunionectomy.   "
141257|NCT01435564|"     The purpose of this pilot study is to estimate the efficacy of a mobile phone based physical     activity intervention in sedentary men and women.   "
141258|NCT01435551|"     From the past research that has been done the investigators have learned that brain cells die     & leave a deposit in the brain known as beta-amyloid. Since alzheimer's is a slow acting     disease the natural immune system does not respond to this illness so this builds up in the     brain. As it builds up it gets into the neurotransmitters in the brain causing more brain     cells to die. As these buildups occur dementia sets in due to more of the brain dying &     effects normal activity.      STUDY WAS CANCELLED      Hypnotherapy will be used to do the following things:        -  Increase the immune system        -  The immune system will begin to clean up the beta-amyloid buildup        -  That removes damage cells of the brain        -  Increase more blood flow to the brain        -  Allows the active brain cells to be trained to carry out daily activities      STUDY WAS CANCELLED   "
141259|NCT01435538|"     Care pathways are complex interventions to support the interprofessional team in the redesign     of their care process. This international cluster randomised trial will analyse the impact of     the development and implementation of care pathways on the interprofessional teamwork.   "
141260|NCT01435525|"     The purpose of this study is to confirm the safety profile / factors which impact safety and     efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium +     amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual     post-marketing use.   "
141261|NCT01435512|"     This is a research study funded by the Department of Defense to test a therapeutic     intervention for male combat veterans who engage in intimate partner violence (IPV). The     investigators hope to decrease the recurrence of relationship aggression and help veterans     manage anger. The primary aim of the study is to test the intervention.   "
141262|NCT01435499|"     The primary objective of this study is to evaluate the safety and feasibility of     administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine     (melanoma GVAX), alone or in combination with low dose cyclophosphamide (CPM), for the     adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily,     the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma     GVAX, including serological and cellular immune responses in patients treated with either the     vaccine alone or the vaccine given with low dose CPM.   "
141395|NCT01433731|"     The purpose of this study is to investigate the safety and tolerability of topical SHP141     applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell     Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients     with Stage IA, IB, or IIA CTCL.   "
141263|NCT01435486|"     Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is     a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a     trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central nervous     system stimulant. In apnea of prematurity, caffeine is believed to work by increasing central     respiratory drive.      Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September     2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea.      A randomized, double-blind, controlled trial with a sample size of 45 patients per group      Data Collection methods, instruments used measurements:      Randomization:      In the emergency department, the patients will be assigned to either one of the two     treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will     prepare sequential sealed vials containing the experimental drugs. Randomization code will be     revealed only after all patients completed the study. The medical team in addition to the     patients will be blinded to the medication delivered. There will be no detectable difference     in the color, smell of the two study treatments.      Guardians or parents of eligible infants will be approached regarding the study, explaining     the purpose and the treatment modalities. Patients will be included after obtaining a verbal     and written consent.      Study Intervention:      Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine     citrate (25mg caffeine citrate equal to 12.5mg caffeine base).      Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study medications     will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous over 30     minutes using syringe infusion pump.      After random assignment, eligible infants will receive one of the study treatments.     Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and     antipyretics may be used as per the discretion of the treating physician.      After stabilization of patients as usually done in Pediatric Emergency Center , patients will     be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring when     indicated.   "
141264|NCT01435473|"     Thromboembolic complications (TCs) are important causes of morbidity and mortality after     pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and     late post-surgical complications, early reoperation, neurologic and organ damage, and     potentially death. The true incidence of blood clots in pediatric surgical patients is     unknown.      The overarching objective of this study is to further our understanding of TCs, including     quantification, characterization and risk stratification. This study will ultimately allow     the development of effective tools for prevention and early identification of TCs, rather     than focusing on treatment alone.   "
141265|NCT01435460|"     This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%)     versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief     of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).   "
141266|NCT01435447|"     Allogeneic stem cell transplantation is potential curative therapy for adult acute     lymphocytic leukemia (ALL). Based on our previous study, the condition with iv-busulfan     (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation     mortality and long-term survival is comparable to most data reported with slightly higher     relapse rate particularly for patients in CR2. In this study, the investigators aim to     further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell     transfusion as consolidation for ALL and graft-versus-host disease (GVHD) prophylaxis.   "
141267|NCT01435434|"     The study is a prospective, trial to test the safety and feasibility of injecting autologous,     isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non     union/delayed fractures. Another objective is to turn this procedure to a standard care     protocol in our department .   "
141268|NCT01435421|"     Acute liver failure (ALF) results from an abrupt loss of hepatic metabolic and synthetic     function and leads to encephalopathy and potentially multi-organ dysfunction. Aetiologies     include autoimmune and metabolic diseases, infectious agents and hepatotoxins. Worldwide,     infectious hepatitis (A, B and E) is the most common cause. In Western Europe and the USA,     ALF is most frequently caused by paracetamol intoxication.      The MBT can produce immediate results to aid in decision making in patients with acute liver     disease. Such a test may affect decision-making regarding transplantation in this setting,     facilitate appropriate discharge from critical care to other hospital units and to home,     provide point of care assessment of therapeutic interventions.      The BreathID can potentially help in determining:        -  Parameter to include patients in transplant list (the UNOS 1A group)        -  Identification that patient deteriorates and needs extended hospitalization/referral to          ICU/change in management        -  An addition to the MELD and or other scores to estimate risk in other acute patients        -  Additional information to that of other commonly utilized prognostic scoring systems      The primary end-point of the study is to develop a model to predict deterioration of the     liver disease, which incorporates measurements from the MBT along with other potential     variables. The data collected will be used to develop a prediction model using data-mining     methodology (linear and non-linear regression models, binary trees, neural networks, etc…).     The predictive models may include measurements from the MBT, blood test results, as single     measurements or as trend over time. The model that will be developed, will attempt to predict     the disease deterioration vs. recovery accurately, at an earlier time point than the standard     procedure. A threshold will then be determinate based on adequate sensitivity and specificity     levels.   "
141269|NCT01435408|"     This study focuses on Cardioprotective strategies.   "
141270|NCT01435395|"     This is a single-center (Emory University), open-label, single arm, phase I study to assess     safety and toxicity of bortezomib in combination with bevacizumab and escalating doses of     temozolomide for patients with recurrent glioblastoma multiforme. Patients requiring     anti-epileptic medications will have to be at least 10 days off EIAEDs. Only non-EIAEDs are     accepted.   "
141271|NCT01435382|"     This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615     in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.   "
141272|NCT01435369|"     The purpose of this research study is to see if the study drug, CT-011, is safe to give and     if it helps people with melanoma that has spread to other areas of their body. CT-011 is a     monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by     infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab     instead of by the immune system which then recruit the immune system to help fight cancer     cells.      All final eligible subjects will receive an intravenous infusion of CT-011. This study will     test two dose levels of the study drug:      Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).      Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).      Each group will be given the study drug through an IV (a needle put into a vein in the arm)     on day 1. After day 1, the study drug will be given every other week. Patients may be given a     total of up to 27 study drug infusions for about 12 months while they are in the study.     Approximately 100 patients will participate in this study.   "
141273|NCT01435356|"     The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic     product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the     bladder. A course of 13 injections will be administered over 27 months.   "
141274|NCT01435343|"     Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte     colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory     Acute Myeloblastic Leukemia (AML) aged 65 or younger.   "
141276|NCT01435317|"     Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of     chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient     setting.        -  Identification of early indicators for therapy success        -  Comparison of different patient groups regarding: tinnitus severity, tinnitus duration,          level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex          forms        -  Representative set of safety data in a broad patient spectrum        -  Measurement of tinnitus burden (TBF-12 Questionnaire)        -  Generation of longterm compliance data   "
141277|NCT01435304|"     This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte     solution) and loss of plasma proteins responsible for normal blood clotting as well as     platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device     qualified by the US Food and Drug Administration (FDA). Many cardiac centers, such as     Englewood Hospital and Medical Center in Englewood NJ are using the Hemobag® system for     Jehovah's witnesses and other patients who go to that center for bloodless cardiac surgery     (cardiac surgery performed without the use of blood or blood products). The system is     designed to filter excessive water from blood left in the heart lung machine (cardiopulmonary     bypass) after it is separated from the patient during the performance of cardiac surgery.     Consequently the likelihood of excessive post-operative bleeding and transfusion with     allogeneic blood (blood bank blood from donors) is decreased.   "
141278|NCT01435291|"     A pharmacokinetics and pharmacogenetics study to complement the current knowledge of     tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at     steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on     tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after     renal transplantation.      Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus     immediate release (Prograf®)   "
141279|NCT01435278|"     To date, there is no clinical evidence on the efficacy and safety of Glucosanol in     maintaining weight loss beyond the study duration of 12 weeks. The rationale for this     open-label study is to assess the efficacy in preventing regain of loss body weight and     safety of Glucosanol in subjects who are overweight or obese over a longer period after the     initial weight loss.   "
141281|NCT01435252|"     Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled     in this study. Patients are treated with standard chemoradiation in combination with     concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation     therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study     is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control     rate.        -  Trial with medicinal product        -  Trial with radiotherapy   "
141282|NCT01435239|"     Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion     in children. However, it is not proven how much the cuff should be inflated. The aim of this     study is to compare efficacy between the method using the resting volume and the method using     half the maximum volume for partial cuff inflation.   "
141283|NCT01435226|"     This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451,     Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in     Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV)     Infection.   "
141284|NCT01435213|"     The purpose of this study is to validate [11C]ORM-13070 as an alpha2C-adrenoceptor imaging     agent for human positron emission tomography (PET) studies of brain alpha2C-adrenoceptor     occupancy.   "
141285|NCT01435200|"     Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients     receiving platinum based chemotherapy than oral iron?   "
141286|NCT01435187|"     In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic,     physiologic and clinical data obtained during the initial hospitalization will predict     respiratory morbidity as defined by respiratory health care utilization and respiratory     symptoms, between discharge and 1 year corrected age.      This protocol describes a collaboratively developed multicenter study of very preterm infants     from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up     to 1 year of age, corrected for the degree of prematurity.   "
141287|NCT01435174|"     End-stage renal disease (ESRD) patients often develop cardiovascular complications, and     cardiovascular disease is the leading cause of death in this population. Ranolazine's ability     to treat angina without reducing heart rate or blood pressure makes it an important option     for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose     pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD     patients on and off hemodialysis. Results of the proposed study will provide initial dosing     estimates for a follow-up, multiple-dose pharmacokinetic study in this population.   "
141288|NCT01435161|"     Different lowing blood pressure strategies have a different clinical efficacies. Blocking the     angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial     fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months     than 30% compared to Nifedipine( Adalat GITS ).      A total of 160 subjects will be included in two study groups. The Group 1 will receive     80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS).     Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and     24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial     fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg.     Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood     pressure during the study.   "
141301|NCT01434992|"     Although endoscopic findings of H. pylori have been reported in the literature, there is     still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic     features alone. Most studies concluded that it is not possible to diagnose H. pylori-related     gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has     greatly improved in recent years and the exact examination of gastric mucosa was possible.   "
141289|NCT01435148|"     Recurrent major depressive disorder affects about 3−5% of the population. It is anticipated     that by 2020, depression will be the most common cause of disability worldwide in the 18−55     age group. About two−thirds of these patients respond to first−line treatment     (antidepressants). In addition, prolonged administration of antidepressants in patients who     respond results in remission in 80% of patients per year. However, a significant proportion     of patients either fail to respond in spite of determined pharmacological treatments,     electroconvulsive therapy and other treatments or do not achieve sustained remission. The     personal, psychiatric, medical, social and economic consequences are devastating for these,     treatment resistant, patients. This investigation aims to evaluate the feasibility of deep     brain stimulation in patients with treatment resistant depression as a viable alternative to     ablative neurosurgery.The hypothesis is that some patients will respond to stimulation in one     site rather than the other and that some patients will respond to double rather than single     site stimulation.   "
141290|NCT01435135|"     The purpose of this study is to assess safety and tolerability of late boost regimens of     AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected     participants from RV 144.   "
141291|NCT01435122|"     The main purpose of this study is to see whether Axitinib will help prolong the time that the     patient's carcinoid tumors remain stable, and to examine their treatment response through     testing. Researchers also want to find out if Axitinib is safe and tolerable.   "
141292|NCT01435109|"     Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain     and disability among adults. Many adults with OA have significant pain and functional     limitations, even though they receive some medical care for their OA. Efforts are needed to     help adults improve OA-related outcomes. This study will examine three different approaches     for helping adults manage their OA-related symptoms. The study will compare a patient-based     intervention (involving exercise, weight management, and cognitive behavioral pain     management), a provider-based intervention (involving provision of patient-specific     recommendations for care, based on evidence-based guidelines), and a combination of the two     interventions, relative to usual care among patients with hip and/or knee osteoarthritis. The     interventions are relatively low cost and easy to disseminate, with the patient component     being telephone based. This study will provide novel, valuable information of the     effectiveness (and cost-effectiveness) of these three interventions in the context of     real-world clinical settings.   "
141293|NCT01435096|"     The purpose of this study was to determine the maximum tolerated dose and the recommended     dose of BN80927 in patients with advanced malignant solid tumors.   "
141294|NCT01435083|"     The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD)     characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers     and children). The main questions the investigators want to answer are:        -  Are differences related to the pathophysiological factors involved in nocturia?        -  Are there age/gender/size differences?        -  Can the investigators identify patients who are likely to develop hyponatraemia?        -  Can the investigators individualize treatment and reduce risk for hyponatraemia?      Day 1:        -  Patient is being hospitalized in the morning        -  General anamnesis and clinical examination        -  Uroflow and residue measurements (3x)        -  Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and          creatinin      Day 1-2:      - In the evening at 20h:        -  start (with empty bladder!) 24h miction-incontinence-residue registration: urine          collections every 3 hours (every portion of urine within a period of 3 hours must be          collected in the same collection device), with: registration of volumes and measurement          urinary concentrations of Na+, Cl-, osmolality and creatinin        -  Measurement of blood pressure during 24h      Day 2-3:        -  In the evening at 19h (day 2): drink 15mL/kg water        -  At 20h: take desmopressin melt 120µg + start:             -  24h miction-incontinence-residue registration: registration of volumes and               measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)             -  Measurement of blood pressure during 24h             -  Collection of urine:U1 at 19h, U2 at 20h, together with intake of first               desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2               after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at               2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin               melt intake             -  Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin               melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+,               Cl-, osmolality and creatinin (safety profile)             -  At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour               during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and               creatinin: U8 at 9h, U9 at 10h, U10 at 11h        -  Patient can go home on day 3, unless he is at high risk for side effects, high-risk          patients are hospitalized for 7 days   "
141295|NCT01435070|"     Patients attending the University Hospital Coventry UK with a broken wrist requiring an     operation, will be invited to enter the study. At the first visit, they will have an xray of     the wrist and will be asked to complete a number of questionnaires. The questions are to     determine if they normally have pain in the wrist and how well they can perform their daily     activities. The patient will then have an operation, and the fracture in the wrist will be     held in the correct position with either a metal plate and screws or wires.      At 6 weeks following the operation the patient will be reassessed and an xray will be taken.     At 3 months, 6 months and 12 months after the operation patients will perform tests to assess     the strength of their grip, pinch and movement of their wrist. In addition they will complete     the the same questionnaires from their first visit. At the 12 month visit patients will have     another xray.   "
141296|NCT01435057|"     In this project, the investigators will test the hypothesis that predominant (two to three     times a week 60 min) strength training is more effective in reducing visceral fat mass than     endurance training in obese patients.   "
141297|NCT01435044|"     This study was designed to assess the safety and efficacy of multiple interferon-free     treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone     and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over     12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit     (sustained virologic response [SVR]) versus risk (safety and resistance).   "
141298|NCT01435031|"     A prospective, multi-center, single-arm study to establish the safety and effectiveness of     the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary     Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary     Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective     percutaneous revascularization of native chronic total coronary occlusions   "
141299|NCT01435018|"     This study is being done to compare the safety and efficacy of three combination treatments     for Kaposi's Sarcoma and AIDS.   "
141300|NCT01435005|"     The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at     understanding what dose (or volume) of exercise will best reduce the risk for breast cancer,     particularly among women who are between the ages of 50-74. The primary aim is to compare the     effects of a high versus moderate volume exercise intervention on specific biological     intermediate endpoints for breast cancer in a group of previously inactive postmenopausal     women   "
141302|NCT01434979|"     The investigators goal is to monitor and quantify the differential physiologic and biomarker     responses of controls to standardized exercise under thermoneutral and thermally challenged     conditions and responses of exertional heat stroke (EHS) subjects under a thermal-challenged     environment to develop unique bio-signature panels to predict those at risk for exertional     heat illness (EHI) and guide return to duty following an episode of EHS.   "
141303|NCT01434966|"     The purpose of this study is to determine if interventions applied at a distant site,     lumbopelvic region (manipulation and TENS), have a similar effect as interventions applied     locally at the knee (TENS) on quadriceps force output and activation as well as reports of     pain during common exercises in individuals with PFPS.   "
141304|NCT01434953|"     The purpose of this study is to find out whether labeling adults with prehypertension has     negative effects on clinic blood pressure and quality of life 3 months after diagnosis.   "
141305|NCT01434940|"     The global aim of our study is to validate eye movement recording as an early differential     diagnostic tool, in order to discriminate as early as possible between neurodegenerative     dementias of Alzheimer type and depressive pseudodementias (DPD). The investigators want to     put forward idiosyncratic oculomotor characteristics of Alzheimer's disease (AD) and DPD     respectively. Eye movements are sensitive markers of neurological diseases and can be used in     a variety of clinical neurological syndromes.      This study compares 3 groups of 98 patients: patients suffering of AD and DPD and healthy     persons. The patients AD will be recruited in the Memory Centre of Resources and Research of     Besançon and patients DPD will be selected in the psychiatric department of the University     Hospital of Besançon. The control participants will be recruited from the entourage of     researchers and patients. The selection of participants in the 3 different groups is based on     clinical examinations in psychiatry and neurology and neuropsychological assessments. After     giving informed consent, patients will be evaluated by a psychiatrist and a     neuropsychologist. The complete assessment takes 150 minutes.      After having set up patients, eye movements will be recorded using video-oculography     techniques. The following tasks are performed: the basic dynamic eye movements (latency,     hypometric and hypermetric saccades, reaction time, saccade speed, accuracy, pupil diameter)     will be evaluated by the pro-saccade, anti-saccade and predictive saccade tasks. The     emotional connotation tasks will be assessed by scan of images pair with emotional     connotation and portrait analysis. The assessment takes 30 minutes.      This study will include 3 groups:        -  an Alzheimer group;        -  a depressed group;        -  a control group with healthy persons. The population of this study will be comprised of          patients over age 60 with a visual acuity over 9/10, not diagnosed with eye disease and          not neuropsychological sequelae that could disrupt the functioning oculomotor.      These people will be recruited on a voluntary basis, after notification and consent in the     research center, the Psychiatry Clinical Department of the University Hospital of Besançon.     This study was conducted over a period of 36 months.   "
141306|NCT01434927|"     The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy,     in a setting where routine sedation for colonoscopy is standard practice and to characterize     the subset of patients willing to try and potentially completing an unsedated procedure.   "
141307|NCT01434914|"     This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in     patients with chronic leg ulcers. The study will be conducted at a single center with a total     of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo     group.   "
141308|NCT01434901|"     Xenin-25 and glucose-dependent insulinotropic polypeptide (GIP) are hormones produced in the     intestine that are released into the blood immediately after ingestion of a meal. Together,     these 2 hormones increase insulin release and reduce blood glucose levels. Xenin-25 works by     increasing acetylcholine release in pancreatic islets. This study will determine if a     Bethanechol, a drug that is similar to acetylcholine, also increases insulin release and     reduces blood glucose levels after ingestion of a mixed meal.   "
141309|NCT01434888|"     The objective of this study is to investigate the pharmacokinetics, safety and tolerability     of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC)     to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy     volunteers.   "
141310|NCT01434862|"     This is a scientific research study that will look at how a closed-loop system and the drug     Pramlintide may work together to improve blood sugar control in people with type 1 diabetes     mellitus. Pramlintide is approved by the Food and Drug Administration (FDA) and is given as     an injection (subcutaneous) that works with insulin to lower blood sugar.   "
141311|NCT01434849|"     The purpose of this trial is to see if a topical beta blocker is effective in preventing the     proliferation of infantile hemangioma.   "
141312|NCT01434836|"     The goal of this project is to train currently major depressed patients on fundamental     aspects of working memory while the investigators administer transcranial Direct Current     Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these training     sessions. This working memory training would be performed using adaptive Paced Auditory     Serial Addition Tasks (PASAT). The effects after two weeks of working memory training     combined with tDCS or sham placebo (10 sessions) will be measured on different variables,     each measured at the start and at the end of the two weeks of training. The investigators     expect the greatest anti depressant results and cognitive enhancements in the group of     depressed patients that received tDCS combined with working memory training.   "
141313|NCT01434823|"     The Hospital of the University of Pennsylvania's Medical ICU (MICU) is implementing a model     of 24-hour intensivist staffing in September 2011. Funds and resources are not available to     cover the entire year, only certain weeks will be covered. The investigators propose a     randomized clinical trial to study the comparative effectiveness of nocturnal intensivist     staffing in the HUP MICU on patient outcomes. The investigators will be collecting and     analyzing patient data of all patients admitted to the MICU from September 12, 2011, to     September 11, 2012.   "
141314|NCT01434810|"     The primary objective of this study is to determine the safety and efficacy of filtered     sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The     subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. The     rationale for conducting the study is that in Nigeria, and other countries that may not have     effective commercial light devices or have reliable access to electric power to operate them,     filtered sunlight phototherapy might offer a safe and effective treatment for neonatal     jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight     phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical     trial comparing the efficacy of filtered sunlight phototherapy with conventional     phototherapy.   "
141315|NCT01434797|"     The study hypothesis is that F-18-FDG PET/CT and microcalorimetry might have a diagnostic     value in the detection of permanent central venous catheters (PCVC) infection when     conventional means of PCVC infection detection are non-conclusive.   "
141316|NCT01434784|"     The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire     Lung Cancer 13 (EORTC QLQ-LC13) is considered as a standard instrument to assess the quality     of life (QL) of lung cancer patients. Since its publication in 1994, major clinical advances     have been made. The research objective is to develop a revised lung cancer module that (a)     covers all QL aspects relevant in the context of newly available diagnostic and therapeutic     options, (b) is applicable in both non-metastatic and metastatic cancers, (c) and covers QL     aspects that are generally relevant for patients with lung cancer but are missing in the     original module. This project will comprise the first three project phases according to the     Module Development Manual (www.eortc.be/qol).   "
141317|NCT01434771|"     The purpose of this study will be to compare standard of care invasive methods to an FDA     approved non-invasive device and a novel wireless non-invasive device, both manufactured by     Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by     the novel device to the measurements taken by the standard of care invasive monitors.   "
141318|NCT01434758|"     Detection of M. tuberculosis in clinical specimens of children has a low sensitivity because     specimens are either difficult to collect or contain low levels of M. tuberculosis.     Diagnostic criteria are non-specific and culture confirmation is challenging, as sputum     samples are not often obtainable from small children and specimens typically have low yield.     Although children are typically thought to have paucibacillary disease, they are at greater     risk for dissemination of TB. This may allow for detection of Mycobacterium tuberculosis from     other bodily fluids than sputum or gastric aspirate, including blood and urine.     Unfortunately, little is known about the overall yield from these various specimens. From     pilot data collected among adults and children in Tugela Ferry, we know that it is feasible     to collect and test various bodily fluid specimens for TB culture. This study aim to test the     hypothesis that blood and urine cultures will detect Mycobacterium tuberculosis from children     suspected of disseminated TB, and that a proportion of these non-sputum bodily fluids will     detect both drug-susceptible and drug-resistant tuberculosis when sputum or gastric culture     does not.   "
141319|NCT01434745|"     The purpose of this study is to determine if simvastatin improves development and behavior in     patients with Smith Lemli-Opitz syndrome (SLOS) receiving dietary cholesterol     supplementation.   "
141341|NCT01434459|"     Therasphere is a form of treatment that has been designed to selectively deliver radiation to     the cancer within the patient's liver. This form of treatment has been used in a number of     clinical trials and has been approved for use in the treatment of liver cancer.      The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with     TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the     tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic     cancer or cholangiocarcinoma (bile duct tumors) involving the liver.   "
141320|NCT01434732|"     Premature babies are at risk for bleeding in their brains, which can result in developmental     delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical     cord immediately after birth is standard, but delaying this procedure allows more of the     baby's blood to move from the placenta into the baby and prevents head bleeds. However, a     delay in clamping the umbilical cord is not usually done in very premature babies, because it     would delay their treatment and they could get cold. Milking the umbilical cord is another     way to give premature babies more of their own blood while avoiding a delay in treatment.     Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood     transfusions, and increase the amount of urine made in the first few days of life.   "
141321|NCT01434719|"     This study aim to test the hypothesis that human S.suis infections are associated in time and     space with outbreaks of Porcine Reproductive and Respiratory Syndrome (PRRS) virus or other     diseases in pigs.   "
141322|NCT01434706|"     The investigators propose to study the impact of nucleic acid amplification testing (NAT)     screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and     Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity     Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction     with routine rapid HIV testing at HIV counseling and testing sites and venues in the San     Diego county. The overarching goal of this study is to develop and implement a system to     identify, notify and engage into care those individuals with recent HIV infection in order to     better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to     evaluate and characterize HIV transmission dynamics within the San Diego population.   "
141323|NCT01434693|"     This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and     7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo),     double-blind, placebo-controlled study to evaluate the safety of a single dose of oral     CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's     Disease.   "
141324|NCT01434680|"     The study was to evaluate the safety and and immune response of each of three lots of     Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy     Toddlers.   "
141325|NCT01434667|"     This study is intended to examine the impact of receiving a genetic risk assessment for     Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).   "
141326|NCT01434654|"     Patients infected with Human Immunodeficiency Virus (HIV) are at risk of brain related     complications despite the use of highly active antiretroviral therapy (HAART). Such     complications are termed HIV neurocognitive disorders (HAND) and comprise a spectrum from     asymptomatic neurocognitive impairment (ANI), through mild cognitive impairment (MCI) to     severe HIV dementia (HAD).      Prior to HAART approximately 30% of patients with advanced HIV disease had cognitive     impairment; with HAART the incidence of HAND has decreased but its prevalence increased. The     reasons for the ongoing development of cognitive impairment in HAART treated patients are not     clear. They might relate to virus induced brain injury prior to starting HAART, the onset of     a separate neurological process, toxicity related to HAART, or ongoing viral infection in the     brain.      It is clear that the ability of different antiretroviral drugs to penetrate the brain varies     but what is not established is whether these differences between drugs lead to different     neurological outcomes. The investigators propose to study HIV infected patients stable on     HAART for 12 months; subdividing the groups according to the brain penetrance of their drug     combination. Patients would undergo neuropsychological assessment and MRI brain scan at the     start of the study and after 12 months.      Differences in neuropsychological tests and MRI would be sought between treatment groups to     establish whether HAART with better CNS penetration is associated with better outcome and     fewer MRI changes.   "
141432|NCT01433250|"     The study will assess the long-term safety and tolerability of AIN457 in patients with     relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of     maintenance of efficacy and health related quality of life will be explored.   "
141327|NCT01434641|"     This protocol details a novel myocardial perfusion Single Photon Emission Computed Tomography     (SPECT) protocol wherein patients receive a low-dose (6 mCi) of Tc-99m sestamibi during     exercise or regadenoson pharmacologic stress and undergo a full-time SPECT acquisition     processed with Wide Beam Reconstruction (WBR). Immediately thereafter patients receive a     high-dose (30-35 mCi) of Tc-99m sestamibi at rest and undergo a half-time rest scan, also     processed with WBR. All enrolled research subjects will undergo both the initial stress and     subsequent rest scan.      The radiation exposure associated with this new stress/rest protocol is equivalent to that of     the conventional rest/stress protocol presently in routine clinical uses at SLRHC.      Eventually, when and if this novel stress/rest protocol is adopted in routine clinical     practice, patients with normal stress scans would receive only 6 mCi of Tc-99m sestamibi (331     mSv in men, 241 mSv in women) and spend only approximately one hour in the Nuclear Medicine     Laboratory.      All patients presenting to the Nuclear Medicine Laboratory for evaluation of known or     suspected coronary artery disease will be candidates for enrollment. Fifty patients     undergoing treadmill exercise stress and 50 patients undergoing regadenoson pharmacologic     stress will be enrolled. Pregnant and breast-feeding patients will not be eligible.   "
141350|NCT01434342|"     RATIONALE: Continued smoking after a cancer diagnosis has important health consequences     beyond the risks associated with smoking in the general population. Smoking reduces the     efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the     negative consequences, it is estimated that between 15-75% of patients with cancer continue     to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head &     neck, and cervical cancer patients were chosen because there is evidence of potential     clinical benefit associated with quitting smoking in all of these populations and they     represent a mix of both smoking and non-smoking related cancers.   "
141351|NCT01434329|"     RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how patients respond to     treatment.      PURPOSE: This research trial studies DNA in samples from patients with acute myeloid     leukemia.   "
141328|NCT01434628|"     A range of observational and epidemiological studies have shown that the lifetime risk of HIV     infection can be reduced by 70% through male circumcision.      Rwanda has a national plan to offer a voluntary male circumcision (MC) program to 2 million     adult men in 2 years as part of a comprehensive HIV prevention strategy. To achieve this     goal, the government launched a national study, based on the WHO Framework for Evaluation of     Adult MC Devices, to assess the safety, efficacy and supremacy of the PrePex™ device when     compared to surgical circumcision.      The PrePex device was developed to facilitate rapid scale up of non-surgical adult male     circumcision in resource limited settings.      Rwanda validated the aforementioned endpoints via physicians in a Safety and Efficacy Study     (NCT01150370) and Randomized, Controlled Comparison Study (NCT01284088). The procedure was     bloodless, required no anesthesia, no sutures and no sterile settings, with 1 AE that was     managed with minimal intervention.      Evidence submitted to members of WHO, USAID, UNAIDS and the Bill and Melinda Gates     Foundation, and WHO audited the study site. The Safety and Efficacy study results were     published in the JAIDS Journal of Acquired Immune Deficiency Syndromes, Sept 8, 2011, and     presented in CROI 2011 and AUA 2011.      To achieve its national catch up campaign with minimal burden to the overly strained health     system, which lacks physicians and surgical infrastructure, Rwanda needs to task shift the     procedure to nurses. This study is meant to test the Safety and Efficacy in the hands of     non-surgically trained nurses from the A1 and A2 cadres.   "
141329|NCT01434615|"     The purpose of this study is to (a) characterize the current management of patients with     systolic heart failure (HF) in South Asia following an educational intervention of current     guidelines and delivery of disease management tools and (b) to characterize the effect of     current therapy on clinical outcomes in patients managed by tertiary care centers across     South Asia. Current therapy includes characterization of the post market performance of any     market released Medtronic cardiac resynchronization therapy (CRT) or cardiac     resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac     resynchronization therapy (CRT).   "
141330|NCT01434602|"     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and     best schedule of the combination of everolimus and sorafenib that can be given to patients     with malignant glioma.      The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib can     help to control malignant glioma. The safety of this combination will also be studied in both     phases.   "
141331|NCT01434589|"     The purpose of this study is to 1) determine the efficacy of manualized Short-term Treatment     of Internet and Computer game Addiction (STICA), assess 2) the durability of treatment     response in these patients and 3) the impact on associated psychiatric symptoms, e.g. social     anxiety and depression.   "
141332|NCT01434576|"     The purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics     of HGS1025 in patients with moderate to severe ulcerative colitis.   "
141333|NCT01434563|"     To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of     HIV positive patients within a primary care setting compared with the HIV negative     population. The investigators aim is to assess the use of optimal screening methods to assess     HAND. For this the investigators will be comparing the performance of a group of persons who     are HIV positive and a group of persons who are HIV negative to test their memory and     concentration abilities over-time.   "
141334|NCT01434550|"     The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and     to find out what effects, good and/or bad, this treatment will have on participants and their     cancer.   "
141335|NCT01434537|"     Evaluation of the AccuVein ® AV 300 vein scanner in clinical routine in a pediatric operation     room setting for a 4 weeks period. Assessment of usability, anonymous clinical register of     every venepuncture(age, gender, size, weight, punction site, number of attempts, time until     successful cannulation, local anaesthesia, general anaesthesia, pain scales: faces pain scale     und BPS/BPOS).   "
141336|NCT01434524|"     The long-term outcomes of branched-chain amino acid (BCAA) administration in patients     undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of     oral supplementation with BCAA on the prevention for the development of liver tumorigenesis     in patients undergoing liver resection.   "
141337|NCT01434511|"     This study is to test whether the study drug (OBI-1) is safe and effective for the treatment     of serious bleeding episodes in people with congenital hemophilia A.   "
141338|NCT01434498|"     This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451,     Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in     Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.   "
141339|NCT01434485|"     The purpose of this study is to confirm the safety profile / factors which impact safety and     efficacy of Nexium capsules in daily clinical usage for the patients who have been prescribed     Nexium for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis,     non-erosive reflux disease, or Zollinger-Ellison syndrome   "
141340|NCT01434472|"     This phase II trial studies the side effects and how well high-dose yttrium-90     (Y-90)-ibritumomab tiuxetan (anti-cluster of differentiation [CD]20) followed by fludarabine     phosphate, low-dose total body irradiation (TBI), and donor peripheral blood stem cell     transplant (PBSCT) work in treating patients with aggressive B-cell lymphoma that has     returned after a period of improvement (relapsed) or has not responded to previous treatment     (refractory). Radiolabeled monoclonal antibodies, such as Y-90-ibritumomab tiuxetan, can find     cancer cells and carry cancer-killing substances to them with less effect on normal cells.     Giving chemotherapy, such as fludarabine phosphate, and TBI before a donor PBSCT helps stop     the growth of cancer cells. It may also stop the patient's immune system from rejecting the     donor's stem cells. However, high-dose radiolabeled antibodies also destroy healthy blood     cells in the patient's body. When healthy stem cells from a donor are infused into the     patient (stem cell transplant), they may help the patient's body replace these blood cells.     Giving high-dose Y-90-ibritumomab tiuxetan followed by fludarabine phosphate, TBI, and donor     PBSCT may be an effective treatment for patients with B-cell lymphoma.   "
141800|NCT01428427|"     MEK112111 is a dose-escalation, Phase IB, open-label, single-arm, multi-center study. The     primary objective of the study is to determine the recommended dose and regimen for the     orally administered MEK inhibitor GSK1120212 dosed in combination with gemcitabine in     subjects with solid tumors.   "
141342|NCT01434446|"     In the late 1990s, researchers discovered that acoustic stimuli slow progressive     sensorineural hearing loss and exposure to a moderately augmented acoustic environment can     delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic     environment could improve age-related auditory changes. These ameliorative effects were shown     in several types of mouse strains, as long as the acoustic environment was provided prior to     the occurrence of severe hearing loss.      In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing     ability against damage by traumatic noise. In particular, a method called forward sound     conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce     noise-induced hearing impairment in a number of mammalian species, including humans.      Interestingly, recent report has suggested that low-level sound conditioning also reduces     free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces     Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased     cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and     compound action potentials (CAPs) were measured.      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of     acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing     ability against acoustic trauma and to prevent the cortical map reorganization induced by     traumatic noise.      In this study, the investigators examine the effect of sound stimulation on hearing ability     in human subjects.   "
141343|NCT01434433|"     This study will evaluate method correlation and mean bias between six B-type natriuretic     peptide (BNP) platforms.   "
141344|NCT01434420|"     Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high     histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse     prognosis than the other forms of breast cancer. It is however a heterogenous group for     histological and molecular level, but also for evolution. Most of the TN is part of the basal     breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.      Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly     of basal type and their prognostic seems better that what could be expected from high grade     tumours and without hormonal receptors. They would be much more frequent in the TN group.     However, at this day, no prospective study was led to estimate this incidence, or to study     the intervention of other genes of predisposition, as well to analyse the links between this     phenotype and their consequences at the germinal or somatic level, in terms of associated     molecular changes and prognosis.      The purpose of this study is, on a prospective study, to lead a joined analysis at the     germinal level, in search of mutations of the main genes of breast cancer predisposition     (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and     transcriptome), by correlating these results to the main clinical parameters.      The 5 years relapse-free survival will also be estimated.   "
141345|NCT01434407|"     The purpose of the meal study is to investigate acute effects on satiety and inflammation of     advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the     meal is affected by food preparation methods: frying/grilling versus boiling/steaming.   "
141346|NCT01434394|"     EGFR is a potential target for new anticancer therapy in head and neck squamous cell     carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the     stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced     apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is     that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally     advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of     this study are the pathological complete response after neo-adjuvant Erbitux-based     chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.   "
141368|NCT01434108|"     The main objective is to evaluate the effectiveness of the experimental drug to reduce plasma     ammonia concentration at a dose that is safe and well tolerated. Ammonia usually rises     significantly in the hours after gastrointestinal bleeding in patients with cirrhosis of the     liver. This increase in the concentration of ammonia facilitates the development of hepatic     encephalopathy.      The study will be divided in two parts:      Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to     confirm the tolerance and safety of the dose of OP that is being proposed for the study     according to the results of phase I and phase II studies in healthy subjects and stable     outpatients with cirrhosis.      Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group     trial. Assignment of treatment will be done according to a list (one at each study site) of     random numbers in blocks that will be concealed until the end of the study. The control group     will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked.   "
141347|NCT01434381|"     Background:      - The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing     in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent     parasites from developing in the mosquito. As a result, the mosquito will not spread malaria     to the next person it bites. However, the vaccine will not directly prevent people from     getting sick with malaria. Researchers want to test the safety of and response to this     vaccine.      Objectives:      - To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel.      Eligibility:      - Healthy volunteers between 18 and 50 years of age.      Design:        -  Participants will be screened with a medical history, physical exam, and blood tests.        -  They will be assigned to a study group to have either two or three doses of the vaccine.          Participants will have checkups after each dose of vaccine,        -  The additional doses will be given 2 months or 2 and 4 months after the first vaccine.        -  Participants will have regular blood tests to check the level of the response to the          vaccine.        -  They will be followed for up to 1 year after the last vaccine to have any additional          tests as needed.   "
141348|NCT01434368|"     Despite the clear importance of adolescence in the emergence of a number of disease states     and processes, there is surprisingly little known about how the endocrine and metabolic     events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic     studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric     disorders, including depression, schizophrenia, and substance abuse. Many of these sex     differences emerge during or shortly after puberty and are maintained until the 5th-6th     decade of life. For example, the two-fold greater risk of unipolar depression in women     compared with men does not appear until adolescence, and prior to puberty girls are not at     increased risk relative to boys. Puberty is a structured, transitional process that can be     influenced by both nutritional factors and environmental stressors; nonetheless, the     variability in the timing and duration of puberty is largely determined by oligogenic     inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying     puberty impact on many of the physiologic systems involved in the regulation of brain     function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal     remodeling, and the pruning of cortical connectivity). Additionally, not only does stress     during puberty increase the risk of disturbances in affective adaptation during adulthood,     but the events accompanying puberty modify stress responsivity (e.g., alterations in the     duration and peak response of hypothalamic-pituitary-adrenal [HPA] axis hormones to     stressors). Moreover, animal work has demonstrated that neural connectivity differs in a     brain regional specific manner according to the stage of puberty (i.e., early versus late).     In humans, puberty also occurs in stages, and although the endocrinology of puberty,     surprisingly, has not been fully characterized with longitudinal data, studies have     documented that the physical changes measured by Tanner stages I to V are accompanied by     progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless,     there remains considerable variability in the timing and duration of this otherwise highly     structured reproductive transition.      We propose to perform a longitudinal, naturalistic study examining changes in brain structure     and function, behavior, and stress responsivity in boys and girls across the pubertal     transition. Because the pubertal transition is defined by a complex series of physiologic     events that emerge sequentially over several years and involve changes in multiple endocrine     and growth systems, and because there is also considerable variability in the timing of these     events reflecting the influence of both genetic and environmental factors, puberty cannot by     delineated by age of the participants as has been done in most imaging and other     neurobiological studies of adolescence. The present study will formally bridge this gap by     defining pubertal events per se in participants.      Participants will include healthy boys and girls whose pubertal status will be assessed, and     in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten     month intervals from age eight years (pre-puberty) until age 17 years (post-puberty).     Reproductive endocrine, metabolic, and physical measures will be employed to characterize the     stage and duration of pubertal development. Outcome measures will be derived via multimodal     neuroimaging techniques, cognitive/behavioral assessments, metabolic measurements, and     evaluations of HPA axis function. Additionally, the impact of genetic variation on the     developmental trajectory of these parameters (both reproductive and CNS) will be determined.      This cross-institute proposal will employ a multidisciplinary approach to evaluating the     effects on CNS function of the process of puberty in both boys and girls. This work will not     only serve to inform research on the mechanisms by which sexual dimorphisms in     neuropsychiatric disorders develop, it will also have important implications for the     prevention and treatment of these disorders.   "
141349|NCT01434355|"     This research trial studies deoxyribonucleic acid (DNA) samples from younger patients with     germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva     from patients with cancer in the laboratory may help doctors learn more about changes that     occur in DNA and identify biomarkers related to cancer.   "
144344|NCT01395056|"     To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin     chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced     killer cells in triple negative metastatic breast cancer patients   "
141353|NCT01434303|"     This phase I trial studies the side effects and best dose of entinostat when given together     with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has     spread from the original (primary) tumor to distant organs or distant lymph nodes or has     recurred (come back) at or near the same place as the original (primary) tumor, usually after     a period of time during which the cancer could not be detected. Entinostat and lapatinib     ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell     growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor     cells to grow and spread. Giving entinostat together with lapatinib ditosylate and     trastuzumab may kill more tumor cells.   "
141354|NCT01434290|"     RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized     radiation therapy that delivers a high dose of radiation directly to the tumor may kill more     tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways     may kill more tumor cells.      PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in     treating patients with prostate cancer.   "
141355|NCT01434277|"     This study is to evaluate the safety of a new preservative in a lubricant eye drop used four     times a day in healthy adults and subjects diagnosed with dry eye.   "
141356|NCT01434264|"     Energy healing is among the most commonly used forms of complementary and alternative     medicine among cancer patients. There are, however, few studies on the effects of energy     healing for cancer and cancer associated symptoms and none of them are of a volume or quality     that allows reliable conclusions to be drawn. Qualitative studies on energy healing in     Denmark have demonstrated that the interventions are individualized and the expected outcomes     personalized. This research points to the need for a research design that can evaluate     personalized outcomes of individualized treatments and at the same time adhere to general     demands of external and internal validity.      The objective of this study is to test the effectiveness of energy healing as an     individualized rehabilitative intervention to improve outcomes of personal choice among     persons who have completed a conventional intended curative treatment for colorectal, breast     and prostate cancer. The study is designed as a pragmatic clinical trial with personalized     outcomes.      The study attempts to maximize external validity by using a design that incorporates     important features of energy healing administered in real-life settings: 1a) allowing     participants self-selection to healing and non-healing control, 1b) assessing individual     participant-selected treatment goals, 1c) allowing the treatment to be performed in the     private clinics of the healers. To maximize internal validity similar to that obtained in a     randomized, clinical trial design, the study will 2a) randomize participants to     self-selection and randomized groups of intervention and control; and 2b) supplement the     assessment of personalized treatment goals with assessment of outcomes with standardized     measures.      The study will account for a number of possible moderators of the effects, including 3a)     socio-demographics and 3b) previous experience with complementary and alternative treatment.     Outcome measures will be assessed by questionnaires, physical measurements, data from     administrative registries as well as semi-structured interviews and participant observation.     Possible patterns in the various forms of data will be examined for concordances and     discrepancies.      Finally, the methods will be discussed in terms of their generalizability as a model for     evaluating personal outcomes of individualized treatments with high levels of external and     internal validity.   "
141369|NCT01434095|"     A half-dose photodynamic therapy, a relative new treatment, has been widely performed to     treat central serous chorioretinopathy.      The researchers aimed to investigate whether the therapy improved the patient's visual acuity     as well as the retinal sensitivity. The researchers also investigate which clinical factors,     if any, were associated with the results; visual acuity or retinal sensitivity after the     treatment.   "
141382|NCT01433926|"     Main objective: To analyze the clinical and biological characteristics of patients with     disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete     remission, partial or stable disease for a period exceeding 3 years.      In addition, there will be a sub-genetic analysis of patients in whom there is availability a     sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with     routine clinical practice, as the tumor samples based on which will be held on genetic     profile, have been preserved in paraffin was extracted from the primary tumor to the patient.   "
141357|NCT01434251|"     Hypotension in the very preterm infant (gestational age [GA] <32 wks) is a frequently     occurring clinical problem. Although no real consensus has been reached on the definition of     hypotension in these infants, in clinical practice a mean blood pressure (mean BP) in mmHg     lower than the GA age in weeks is considered to be the starting point for anti-hypotensive     therapy. However, although an association between neonatal hypotension and mortality/     morbidity exists, there is no evidence of causality between hypotension (meanBP <GA in     completed weeks) and neonatal mortality/morbidity. In addition, using mean BP alone as the     indication of treatment of neonatal cardiovascular compromise without taking into     consideration the status of tissue perfusion may lead to unnecessary exposure of neonates to     vasoactive medication. This medication can be potentially harmful to these extremely     vulnerable patients.      The aim of this study is to compare neonatal mortality and short-term neurodevelopmental     outcome (cerebral ultrasound during the first 7 days of life, advanced MRI indices of     structural brain injury at term GA) and long-term neurodevelopmental outcomes (Bayley scales     of infant development III [BSID-III] at 24 months) between two groups of very preterm infants     presenting with hypotension without clinical and laboratory evidence of compromised tissue     perfusion during the first 3 days of life. Hypotension will be defined as the mean BP (in mm     Hg) lower than the infant's GA (in weeks). Patients randomized to Group A will be treated     according to the treatment protocol operative in the Neonatal Intensive Care Unit (NICU) of     the University Medical Centre Utrecht (UMCU) while Group B will receive no cardiovascular     support for hypotension unless they have evidence of compromised tissue perfusion and     end-organ function ((i.e. near infrared-monitored regional cerebral oxygen saturation (ScO2)     <50% despite optimized ventilatory support and FiO2 administration, plasma lactate >6 mmol/L;     and/or urine output <0.6 mL/kg/hour) or mean BP >5mmHg lower than the current guideline.      The investigators hypothesize that there will be no differences between the two groups     concerning short and long-term neurodevelopmental outcomes.   "
141358|NCT01434238|"     The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant     feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12     months of age.   "
141359|NCT01434225|"     NEMO is a multicentre pan European clinical trial with the aim to develop new treatment     strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There     is evidence that bumetanide improves GABAergic function of the current standard drug,     phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around     thirty years. This trial should confirm that Bumetanide in addition to standard treatment     will result in better seizures control.   "
141360|NCT01434212|"     The purpose of this study is to determine whether the outcome of interferon therapy on HCV     infected patients can be early precisely predicted with a novel mathematic method with     Chinese population.   "
141387|NCT01433861|"     The choice of surgical strategy for patients with proximal gastric cancer is controversial     mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and     anastomotic stricture. but there are no prospective randomized trials until now.      The primary end point of this study is whether the rate of reflux esophagitis is different or     not between LAPG and LATG. Through this study, we   "
141423|NCT01433367|"     This study will be a non-randomized trial consisting of patients with single level (C3 to C7)     symptomatic cervical disc disease who have not previously received fusion surgery at the same     level, and have failed to improve with conservative treatment for at least 6 weeks prior to     enrollment, or who present with progressive neurological symptoms or signs in the face of     conservative treatment.   "
141361|NCT01434199|"     As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more     and more screening colonoscopies are now being performed for prevention or early detection of     this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to     make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is     highly variable and dependent on individual experience. Colonic looping is the commonest     cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological     imaging technique to provide real time, three-dimensional image and position of the     colonoscope during the procedure. It may facilitate straightening of colonic loops and hence     cecal intubation.      The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across     endoscopists of all levels of experience by making use of the newly developed Endoscopy     Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.      The investigators propose to conduct a prospective randomized controlled trial to compare the     caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance.     Colonoscopies performed by endoscopists with different level of experience will be randomized     to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation     (PCS) containing propofol and alfentanil will be given to all patients. The investigators     hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate     (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative     medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy     screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort     during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy     in trainees.   "
141362|NCT01434186|"     To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination     with Metformin in pediatric patients with type 2 diabetes   "
141363|NCT01434173|"     Moxifloxacin is a broad-spectrum antibacterial agent used to treat common community-acquired     respiratory tract infections, complicated intra-abdominal infections, and pelvic inflammatory     disease. In the clinical development program, moxifloxacin was associated with some hepatic     adverse drug reactions. To evaluate further the hepatic safety profile of moxifloxacin, a     retrospective cohort study with nested case-control analysis will be conducted to assess the     rate of noninfectious acute liver injury among new users of moxifloxacin and of other     antimicrobials prescribed for similar indications, including amoxicillin, amoxicillin plus     clavulanic acid, cefuroxime, clarithromycin, doxycycline, levofloxacin, and telithromycin.      The study will be implemented in the population included in the HealthCore Integrated     Research Database (HIRD). Eligible patients are adults aged 18 years and older with     continuous enrollment in the HIRD for at least 6 months before their first claim for a     prescription for a study antimicrobial. Follow-up will start at the date of the first     prescription until the date of the earliest of the following events: noninfectious acute     liver injury, occurrence of an exclusion criterion, end of study period, disenrollment from     database, or death. Patients with chronic alcoholism or cirrhosis, infectious hepatitis,     HIV/AIDS, or pregnant women will not be included.   "
141364|NCT01434160|"     The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped     intrauterine contraceptive system in female adolescents under 18 years of age. Approximately     300 generally healthy, post-menarcheal female adolescents with regular menses at the     beginning of the study requiring contraception will be enrolled into the study.      Duration of study treatment is approximately 12 months with an option to continue the use of     the contraceptive system up to three years if the woman is willing to continue the use after     the first 12 months.      The incidence of adverse events over 12 month treatment period will be the main outcome of     this study. Also the efficacy (number of pregnancies), discontinuation rate and     pharmacokinetics will be evaluated.   "
141365|NCT01434147|"     Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab     followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma   "
141366|NCT01434134|"     Women treated for breast cancer are at increased risk for cardiovascular disease, including     heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators     want to assess if heart failure medications such as beta blockers and angiotensin receptor     blockers can prevent cardiac dysfunction during early breast cancer therapy.   "
141367|NCT01434121|"     The major goal of this project is to determine whether intravenously infused ascorbic acid is     safe for use as a viable therapeutic strategy in adult humans with sepsis.   "
141383|NCT01433913|"     This randomized phase II trial studies how well metformin hydrochloride works compared to     placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride     may make some enzymes active. These enzymes may block other enzymes needed for cell growth     and stop the growth of tumor cells.   "
141370|NCT01434082|"     The investigators are doing this study to look at sleep problems, daytime sleepiness, and     thinking and behavior patterns in children with arthritis and in children without arthritis.     Arthritis is a problem with joints. Some children have arthritis and some children do not     have arthritis.      Sleep disordered breathing is a sleeping problem in which some children snore and have pauses     in their breathing during sleep. It is associated with not enough or fragmented sleep, poor     school performance, problems paying attention, and behavior problems.      The investigators do not know how many children with arthritis have sleep problems, and how     it is linked to daytime sleepiness and children's learning, and behavior patterns compared to     children without arthritis. The investigators need to study both children with arthritis and     children without arthritis to learn more about these connections and to understand if they     are the same or different in children with arthritis and in children without arthritis.   "
141371|NCT01434069|"     This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and     FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated     dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.   "
141372|NCT01434056|"     The purpose of this study is to determine whether hepatic encephalopathy, measured through     magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds     prognostic information to patients who are waiting for liver transplantation. If this model     improves mortality prediction this might be used in the future for organ allocation.   "
141406|NCT01433588|"     The purpose of this study is to see if the Calmer is more effective at managing acute pain in     preterm infants in the neonatal intensive care than the current standard of care in the unit.      Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain     scores and lower heart rates, and more stable autonomic regulation as measured by heart rate     variability indices, than infants given a soother plus facilitated tucking (standard of care)     during routine blood collection.   "
141970|NCT01426178|"     Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony     reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support     (PSV) mode.      The purpose of the protocol is to compare asynchrony rate between periods of pressure support     and periods of NAVA.   "
141373|NCT01434043|"     This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity,     specificity, positive and negative predictive value, and receiver operator curve area under     the curve) of cardiac computed tomography (CT) perfusion as compared to the best non-invasive     test of blood flow -- cardiac positron emission transmission (PET) perfusion imaging.      The primary outcome of the study is to determine the CT perfusion technique with the highest     overall diagnostic accuracy measured by the highest area under the receiver operator curve.      The investigators will test 4 different CT perfusion techniques. (A) Qualitative, visual     inspection of the contrast-enhanced CT images (B) Enhanced voxel distribution analysis (C)     Rate of myocardial contrast enhancement analysis (D) Quantitative heart blood flow using a     distributed 2-region analysis      A second aim is to reduce the radiation dose needed to maintain CT perfusion diagnostic     accuracy. Using the CT perfusion data, the investigators will model the minimal number of     cardiac cycle radiation exposures needed to keep the diagnostic accuracy similar to the full     data set.      A third aim is to test the incremental diagnostic accuracy of CT angiography plus CT     perfusion to identify regions of low blood flow as compared to PET perfusion alone.   "
141374|NCT01434030|"     Development of a bio-behavioral stochastic model-predictive controller (SMPC) for use as an     artificial pancreas in T1DM requires fundamental behavioral and physiology studies, as well     as translational modeling and engineering development. In order to be successful, closed-loop     control in Type 1 Diabetes Mellitus (T1DM) must adapt to individual physiologic     characteristics and to the behavioral profile of each person. An essential part of this     adaptation is biosystem (patient) observation. The investigators propose to lay the     foundation for a closed-loop control system which will include algorithmic observers of     patients' behavior and metabolic state.   "
141375|NCT01434017|"     Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or     without adenoidectomy may be as high as 75%.      Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and     serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic     antiemetic treatments:        -  dexamethasone alone (250 mcg/kg)        -  dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)        -  dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).   "
141376|NCT01434004|"     The purpose of this study is to determine whether a vegetable-based diet, physical activity     program, and stress reduction training will reduce or maintain PSA levels, an indicator of     prostate cancer progression, in men who have had their prostate gland removed following a     prostate cancer diagnosis.   "
141377|NCT01433991|"     This is a multicenter, open-label, Phase 1b/2 study which will be conducted in two parts: a     Phase 1b part comprising a dose escalation and an expansion cohort; and a Phase 2 part which     will comprise two cohorts. The purpose of the Phase 1b part is to identify the maximum     tolerated dose (MTD) of E7050 and E7080 (lenvatinib) in combination in subjects with     unresectable advanced or metastatic solid tumors. In the subsequent Phase 1b expansion cohort     and Phase 2 cohorts, additional subjects with recurrent glioblastoma or unresectable Stage     III or Stage IV melanoma and disease progression after prior systemic treatment will be     enrolled to confirm the MTD (expansion cohort) and to further explore the clinical activity     of E7050 and lenvatinib.   "
141378|NCT01433978|"     Core study:      To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in     addition to standard of care) for the treatment of adult participants with chronic immune     thrombocytopenia (idiopathic thrombocytopenic purpura [ITP]) as measured by durable platelet     response.      Open-label Extension Phase:      To evaluate the safety and tolerability of long-term therapy with avatrombopag in     participants with chronic ITP (cITP).   "
141379|NCT01433965|"     The purpose of this study is to determine whether lenalidomide can stop the growth of     leukemia stem cells and can be used to prevent the return of leukemia cells after a     transplant.   "
141380|NCT01433952|"     Elevated levels of thiamine may increase cellular energy metabolism by increasing the     activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial     affect in patients with several diseases including sepsis, heart failure, and diabetes. There     is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.      The aims of this study are to:        -  Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral          thiamine in healthy volunteers;        -  Compare the different thiamine doses on the pharmacokinetic variables using repeated          measures ANOVA.   "
141381|NCT01433939|"     The investigators wish to study the effects of position changes during colonoscope insertion     on patient comfort. The investigators hypothesize that early position changes would reduce     colonoscope loop formation and patient discomfort.   "
141384|NCT01433900|"     A 1-year prospective, randomized, investigator-masked trial comparing the confocal and     clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved     prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.   "
141385|NCT01433887|"     The Chinese patients with chronic hepatitis C have a different genetic background, which had     been demonstrated to significantly influence their responses to pegylated interferon and     ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6     infection were treated with pegylated interferon and ribavirin. Their response was compared     amongst different genotypes.   "
141386|NCT01433874|"     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter     hospitalizations, and less post-operative pain as compared with traditional laparotomies.     However, there is marked interindividual variability of post-operative shoulder-tip pain     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours     after surgery.      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic     nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is     that if the investigators could reduce carbon dioxide retention in the pelvic cavity.      This clinical controlled trial is tried to find out the practical and clinical maneuver to     reduce post-operative should-tip pain following laparoscopic surgery.   "
142540|NCT01418742|"     Skin toxicity treatment in patients with advanced or metastatic colorectal cancer (mCRC) and     non-mutated (wild-type) KRAS treated with panitumumab monotherapy after failure of     fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.   "
141388|NCT01433848|"     The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in     studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac     changes were caused not only by the myotoxic effects of alcohol, but also are present in many     patients regardless of etiology of cirrhosis.      These changes are characterized by abnormalities of systolic contraction in patients     undergoing physical or pharmacological stress, changes in diastolic function and     electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy.     Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.      To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic     patients, or their relationship with the prognosis of affected patients. Til now, researches     are based on strict echocardiographic parameters, not including several modern methods of     assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain,     can bring new diagnostic and prognostic information, and it is not reported in the     literature. Therefore, the aim of this study is to determine the morphological and functional     cardiac changes in patients with cirrhosis and their prognostic role by evaluating new     echocardiographic parameters of systolic and diastolic readings.   "
141389|NCT01433835|"     The purpose of this study is to determine the safety and pharmacokinetics following a single     oral dose of MBX-400.   "
141390|NCT01433809|"     This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies     (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their     utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid     neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic     mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and     unstained slides to specific biomarker results using immunohistochemistry.   "
141391|NCT01433796|"     Background: Increased access to antiretroviral therapy (ART) in Africa will require     decentralization to primary health care. For this purpose, adapted methods for management of     patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in     patients starting ART, and assessment of co-administration of ART and TB treatment are     priorities in this field.      Aims: To identify clinical predictors of TB in patients starting ART, and to construct     screening algorithms for TB in this population; to assess ART outcomes in patients receiving     TB treatment at health centre level.      Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of     HIV positive patients initiating ART is prospectively followed. Baseline characteristics are     registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as     well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV RNA     levels are followed. Patients with TB are compared to those without TB with regard to ART     outcome. Baseline factors associated with TB will be used to construct TB screening     algorithms.      Recruitment of the cohort was completed in March 2013; follow-up for determination of long     term outcome of ART will be continued until 2016.      Significance: These studies give insight into TB-HIV co-infection at primary health care     level in a Sub-Saharan region, and may impact future guidelines for management of such     patients.   "
141392|NCT01433770|"     Alefacept, also known as Amevive®, is a medication approved by the Food and Drug     Administration (FDA) in the United States and other countries for the treatment of psoriasis,     which is a chronic inflammatory immunological skin condition that can result in chronic dry,     red patches that are covered in scales. Alefacept is approved by the FDA for the treatment of     psoriasis but not as an anti-rejection medication in transplant patients. It is now being     tested in new kidney transplant patients as a supplement to other approved anti-rejection     drugs. Alefacept will be used as an investigational drug in this study.      The reason for this study is to test whether using Alefacept will inhibit T cells, known as     memory cells, using a test named ELISPOT-IFN. In patients with psoriasis, Alefacept inhibits     these memory cells. If memory cells specific to your donor can be inhibited by this drug, it     might prevent rejection and promote acceptance of the transplanted kidney in a unique manner.   "
141393|NCT01433757|"     The purpose of this study is to evaluate if the antibiotic Ampicillin is safe and tolerated     in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to     patients treated with a placebo. A placebo is a pill that looks and tastes the same as the     real drug, but without the active ingredient. The second objective of this study is to     determine if dystonia symptoms improve while on the study drug.   "
141394|NCT01433744|"     The hypotheses tested were that levels of C-Reactive Protein (CRP) would be higher in     patients with chronic periodontitis in comparison with those without periodontal disease and     that the non-surgical periodontal treatment would decrease levels of CRP in patients with     chronic periodontitis.   "
141396|NCT01433718|"     Anterior cruciate ligament (ACL) tears are disabling injuries that place a significant burden     on the athlete. Roughly 80% of these injuries are linked to a noncontact mechanism, with more     than 70% of them occurring while landing from a jump. Female athletes are at higher risk of     sustaining a noncontact ACL injury due to the higher number of risk factors that they possess     compared to their male counterparts. Due to this statistic, ACL prevention programs have been     developed over the past 15 years in attempt to reduce this risk among the female athletic     population. These programs have been shown to reduce the rate of noncontact ACL injuries in     females by correcting the risk factors associated with them. However, it remains unclear as     to whether these positive results are solely due to the program or a higher exercise workload     in its participants. The purpose of this study is to evaluate the effectiveness that an ACL     prevention program has on modifying at-risk landing mechanics (associated with noncontact ACL     injury) compared to a resistance training program of equal workload.   "
141407|NCT01433575|"     This single-center, open-label, single dose, randomized, two-way cross-over study will     evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese     volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20     mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be     re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.   "
142541|NCT01418729|"     The purpose of this study is to evaluate the overall survival (OS) in order to assess the     efficacy and safety of pravastatin as adjuvant treatment to sorafenib.   "
141397|NCT01433705|"     Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers)     in the heart using PET imaging. These tracers would be eventually used in evaluating the     hearts of patients with heart disease.      Normal healthy volunteers will be carefully screened for this study. Subjects will be given     IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not     excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will     undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the     hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin     according to standard procedures in our laboratory.      These same subjects will have a F-18 FDG protocol after following a high fat, protein     permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The     F-18 FDG radiotracer will be given through an IV.   "
141398|NCT01433692|"     Background: Cannabis is the most prevalent illegal drug used in France, and consequences     arising from the step of 'casual consumers'(1-10 joints/month). Side effects of cannabis are     now well documented: Trauma (driving after consuming cannabis), respiratory, cardiovascular     diseases and psychiatric and social problems. The general practitioner (GP) is the health     professional most viewed by adolescents. Brief interventions (BI) for adult alcohol use have     been shown to be efﬁcient. Some BI have been designed to inspect adolescents and consumption     of cannabis have been piloted, showing their feasibility, but no test has validated them.      Aim : Does a BI conducted by general practitioners reduce consumption of canabis in 15 to 19     years old ?      Method:      Two preliminary qualitative studies (with adolescents and GP), were used to analyze the     difficulties of communication around cannabis use. The Scientific Committee has analyzed the     results and developed a workshop around BI, adapted to adolescents cannabis users.      CANABIC is a quantitative study to validate use of BI with cannabis users: a randomized     controlled trial, clustered study, comparing an intervention group (IG) and a control group     (CG). The intervention is the achievement of the IB during a specific consultation. The     outcome is the consumption of cannabic (Number of joints / month).      The study will be carried out in 3 french regions : Auvergne, Rhône-Alpes and     Languedoc-Roussillon. 150 GPs wil be recruited and randomized in intervention group or     control group (ratio 1 :1).      Each GP will inlcude 5 adolescents (i.e. a total of 750 adolescents) - . The number of     adolescents needed has been calculate with hypothesis of a significant difference of 30% in     consumption of cannabis between adolescents who beneficied of BI (IG) and those who do not     experienced BI ( CG) A pilot study has been conducted. Cannabis use by adolescents has     decreased. Their perception of cannabis has changed: they are aware of the harmful effects of     their consumption. This pilot study has improve many points of the protocol.      Results:      A decrease of 30% of consumption is expected (joints per month). Perception of cannabis by     adolescents will be reviewed.      Conclusions:      To validate an IB adaptated to consultation with adolscents cannabis consumer in order to     provide a tool for GP in their daily practice.   "
141399|NCT01433679|"     The primary purpose of this study is to test whether rewarding physical activity with a     motivational website will increase physical activity levels in middle school-aged children     over six months. As a secondary outcome, the study also tests the intervention's impact on     biological measures of inflammation and metabolic function in a sub-set of study participants     who agree to provide blood samples.   "
141400|NCT01433666|"     The aim of the current project is to validate PDE4 inhibitors as a target for cognition     enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will     demonstrate whether memory, but also attention, information processing or executive function     improves with the PDE4 inhibitor roflumilast in healthy humans.   "
141401|NCT01433653|"     The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for     complicated grief is superior to wait list condition in patients with comorbid complicated     grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be     compared to changes in the wait list group.   "
141402|NCT01433640|"     This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D     (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than     95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study     will then be used to design additional studies.   "
141403|NCT01433627|"     This protocol describes a study to compare intended trans-radial versus trans-femoral     intervention and bivalirudin monotherapy versus current European standard of care consisting     of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via     the use of one of the three available agents on the market (e.g. abciximab, tirofiban or     eptifibatide) in patients (≥18 years) with ACS, that are intended for an invasive management     strategy. This study will be conducted in compliance with Good Clinical Practices (GCP)     including the Declaration of Helsinki and all applicable regulatory requirements.   "
141404|NCT01433614|"     Anthracycline-taxane regimens are effective means of postponing progression in metastatic     breast cancer. It is yet unclear whether addition of capecitabine to this combination     improves the treatment outcome.      Patients with advanced breast cancer are randomized to first-line chemotherapy with a     combination of epirubicin (Farmorubicin®) and paclitaxel (Taxol®) alone (ET) or in     combination with capecitabine (Xeloda®, TEX). Starting doses for ET are epirubicin 75 mg/m2     plus paclitaxel 175 mg/m2, and for TEX epirubicin 75mg/m2, paclitaxel 155 mg/m2, and     capecitabine 825 mg/m2 BID for 14 days. Subsequently, doses are tailored related to side     effects.      Primary endpoint is progression-free survival (PFS); secondary endpoints are overall survival     (OS), time to treatment failure (TTF), objective response (OR), safety and quality of life     (QoL).   "
141433|NCT01433237|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers in samples from patients with     rhabdomyosarcoma.   "
141771|NCT01428804|"     The purpose of the study is to investigate the effect of tDCS applied at the anodic left     DLPFC of patients with resistant depression compared to patients treated with conventional     therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in     resistant depression.   "
141405|NCT01433601|"     This project aims to assess different antiretroviral treatment strategies, optimally     controlled and conventional, in relation to drug resistance and virological treatment     failure. A Randomised Controlled trial (RCT) where Vietnamese HIV+ patients with CD4+ T-cells     <200/ul are randomized into either enhanced treatment support (ETS) through peer supporters     or The National AIDS Control Program recommended self supervised treatment (SST). The     treatment strategies will be assessed and compared in relation to treatment adherence and     drug resistance development with virological treatment failure as primary endpoint. The     results from this project will lead to an increased knowledge in relation the impact of     treatment support on adherence, virological suppression and resistance development and have     an impact on HIV treatment policies in low income settings globally.   "
141408|NCT01433562|"     This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the     efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a     neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast     cancer.      The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The     neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each     cycle will be 21-28 days.   "
141409|NCT01433549|"     The purpose of this study was to assess the impact of lens-free (recovery) intervals of     varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.   "
141410|NCT01433536|"     Bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster     than in other patients. However, such patients are also occasionally prone to bone formation     in soft tissues such as muscle. This process is called heterotopic ossification and tends to     occur around joints. Patients with heterotopic ossification often suffer from complications     such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. Loss of     movement can also interfere with function and the quality of life of patients already     experiencing difficulties associated with their trauma. Positioning, transfers, and hygiene     become difficult and even impossible, which worsens the loss of autonomy.      Previous research has suggested that an osteoinductive factor (which has the capacity to     induce the formation of bone) may be released into the bloodstream following a head or spinal     cord injury. The investigators laboratory has shown that a growth factor called BMP-9, when     injected into a damaged mouse muscle, has the ability to cause strong ossification in damaged     muscle. The investigators would like to find out whether the levels of BMP-9 and/or its     receptor (which is called ALK1) increase after traumatic brain and spinal cord injuries that     occur at the same time as serious orthopaedic traumas.      The main goal of the investigators study is thus to determine whether BMP-9 levels increase     in the serum of trauma patients.   "
141411|NCT01433523|"     The purpose of this trial is to investigate if treatment with house dust mite allergen     immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust     mite induced asthma.   "
141412|NCT01433510|"     The purpose of this study is to assess the safety profile of specific immunotherapy with     Grazax for three consecutive grass pollen seasons.   "
141413|NCT01433497|"     The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day     versus placebo in the treatment of patients with primary progressive multiple sclerosis or     relapse-free secondary progressive multiple sclerosis.   "
141414|NCT01433484|"     This study aims to reduce cardiovascular disease (CVD) risk and disparities in risk by     improving lifestyle factors which underlie the development of CVD. The first steps will     involve conducting a comprehensive formative evaluation to assess individual, interpersonal,     organizational, community, and policy factors relevant to CVD risk and risk reduction in     Lenoir County. This will be followed by a community-based lifestyle intervention program     designed to improve eating patterns, promote physical activity, and for those who are     interested, support weight loss. A randomized trial comparing the effectiveness of two     community based weight maintenance interventions will also be conducted. Community-wide     policy and environmental change interventions will also be implemented to support the     individual-level interventions, including partnerships with businesses to promote a healthy     environment through innovative economic opportunities. In addition, this project will explore     genetic factors associated with cardiovascular disease risk and treatment success.   "
141415|NCT01433471|"     The purpose of this study is to understand the immune response activated in the human     gastrointestinal tract by Trichuris Suis Ova (TSO) in patients with ulcerative colitis.   "
141416|NCT01433458|"     This study will assess the pharmacokinetics of RLX030 during and after administration in     subjects with mild to severe hepatic impairment and matched healthy control subjects.      20 to 24 patients and 20 to 24 healthy subjects will be enrolled.   "
141417|NCT01433445|"     This study will assess safety as well as establish a Recommended Phase II dose of the     combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F     mutation who have been diagnosed with primary myelofibrosis (PMF), Post Essential     Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).   "
141434|NCT01433224|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer. It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial studies samples from younger patients with malignant germ cell     tumor progression.   "
141435|NCT01433211|"     The purpose of this study is to investigate the association between nutrition and frailty in     older community-living persons.   "
141418|NCT01433432|"     The open label extension study (Protocol C2/13/DR-6MP-02 EXT) is designed to evaluate the     clinical efficacy and safety of 80 mg DR-6MP test formulation for an additional 12 weeks in     subjects who already completed 12 weeks of Protocol C2/13/DR-6MP-02. Crohn's disease (CD)     therapy is aimed at reducing inflammation via induction of remission after a flare-up and     maintenance of the remission for as long as possible. The questions being asked in this     extension study are:        1. For subjects who received 80 mg DR-6MP for 12 weeks: Can the clinical efficacy and          safety status achieved following 12 weeks of treatment be maintained or improved          following an additional 12 weeks of DR-6MP treatment?        2. For subjects who received oral Purinethol (1-1.5 mg/kg daily) for 12 weeks: Can the          clinical efficacy and safety at 12 weeks be maintained or improved following the          introduction of 12 weeks of 80 mg DR-6MP treatment?   "
141419|NCT01433419|"     The purpose of this study is to evaluate the safety and efficacy of treatment with TAK-875 in     diabetic patients.   "
141420|NCT01433406|"     The purpose of this study is to evaluate the safety and efficacy of long-term treatment with     TAK-875 in diabetic patients.   "
141421|NCT01433393|"     The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in     diabetic patients.   "
141422|NCT01433380|"     The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of     PF-05175157 in healthy volunteers   "
141424|NCT01433354|"     The purpose of this study is to generate long-term safety, tolerability and efficacy data for     AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214     study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients     below 18 years of age provided the patient is at least 12 years of age at the time of entry     into the current study.   "
141425|NCT01433341|"     Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of     electronic signals emitted by four footplates, one for each heel and toe, respectively. These     are sensitive to vertical pressure produced by a subject standing straight but in various     positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields     additional parameters not obtained by the traditional monoplate stabilometers, namely,     weight-distribution patterns and correlation among six combinations of paired outputs from     the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric     synchronizations).      Most athletic injuries occur at the end of an activity, when the participant is fatigue. It     is likely that significant portion of the injuries result from instability of the lower     extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue     increase postural sway, impaired muscle control, and increase the onset delay of movement.     Comparing pre-exercise with post-exercise results for each athlete, should detect significant     and clinically meaningful differences with the Tetra-ataxiametric measures of stability,     interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and     synchronizations of toe parts. The method is suitable for young subjects, and the equipment     is portable and tests can be conveniently carried out in a child's familiar training setting     and right before/after exercise.      The goal of the present study is to measure the balance of the athletes after different types     of exercises, to measure the ability of the athletes to recover different types of exercises,     and to measure the influence of increasing physical fitness on balance ability. Fifty     basketball and football players between the ages of 12 and 18 years old will be examined     following informed consent from the children and their legal guardian. Each participant would     be measured three times during the year (pre-season, middle-season, and post-season), three     times each (before-training, after aerobic warming-up, and after-training) on the Tetrax.     Additionally, physical parameters (as height, and weight), anatomical parameters (as leg     length), and joint range of movement, would be record.   "
141426|NCT01433328|"     Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating     pulmonary arterial hypertension but infusion site pain may be very severe in some patients.     The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion     of lidocaine (a local anesthestic) to treat the pain.   "
141427|NCT01433315|"     Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The     investigators wish to determine whether 9 nights of modest sleep restriction results in     activation of cardiovascular disease mechanisms, thus potentially increasing the risk of     cardiovascular disease. The investigators hypothesize that sleep restriction will result in     elevated blood pressure, inflammation, and neurocognitive deficits.   "
141428|NCT01433302|"     The goal of this clinical research study is to measure the amount of inflammatory proteins     inside the body before and after lymphatico-venular bypass surgery. This will help doctors     learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can     improve how well the surgery works.   "
141429|NCT01433289|"     The purpose of this study is to determine the safety, toxicity, dosing, and antiviral effects     of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered orally twice     daily at three different doses in HIV-1-infected clinically stable, treatment-naïve and     treatment-experienced adults not on concomitant antiretroviral (ARV) therapy.   "
141430|NCT01433276|"     Indication: Resuscitation in pts with hemorrhagic shock due to multiple injuries      Prospective, open label RCT in pts. with traumatic hemorrhagic shock in RS Hasan Sadikin     Hospital, Indonesia.      PI: Dr. Kiki Lukman, PsBD(K), Surgery, RSHS. Co-PI: (late)Prof. Xavier Leverve MD, PhD,     Directeur, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université Joseph Fourier,     France      Hemorrhagic shock is a cause of death in trauma.Fluid resuscitation to ensure stable     hemodynamics and microcirculation by rapidly restoring circulating plasma volume could be a     cornerstone of managing trauma patients. Excessive fluid accumulation particularly in the     interstitial tissue should be avoided. Hypertonic solution shows promise in restoring     intravascular volume expansion and microcirculation with less fluid infusion in hypovolemic     patients. This study investigated efficacy and safety of hyperosmolar Na lactate(Totilac®)     for resuscitating traumatic hemorrhagic shock patients.      Patients with multiple injuries with grade III hemorrhagic shock and RTS ≥4 received std     initial fluid resuscitation of upto 2 liters of isotonic crystalloid. They also got similar     dose of either hyperosmolar Na lactate or ringer's lactate. Hemodynamic status, fluid balance     and and safety was recorded during the study.   "
141431|NCT01433263|"     A safety & efficacy clinical study of the investigational medicinal product BYM338 for the     treatment of unintentional weight loss in patients with cancer of the lung or the pancreas   "
141436|NCT01433198|"     Aim:      - to investigate the effects of an aquatic exercise program in patients with severe scars      Patient population:        -  10 patients of at least 18 years old        -  patients with scars after burns or other severe skin injuries        -  stratification into two groups: an intervention group and a control group      Method:        -  8 patients will participate in the aquatic exercise group and 2 patients in the control          group        -  assessment of physical fitness parameters, scar tissue and psychosocial impact      Hypothesis:      - patients of the aquatic exercise group will recover sooner and better (physically and     psychologically) than patients of the control group   "
141452|NCT01432990|"     Until now, there's still no any strong evidence supported which is the best way to     restoration walking ability in spinal cord injury. Most of the evidence suggest that, there     is somehow better after gait rehabilitation for ASIA classification C and D but not improved     walking ability for ASIA classification A and B. There is an RCT showed the evidence of     repetitive locomotor training and physiotherapy could be improved walking and basic     activities of daily living after stroke, these might be also really effect in SCI patients.   "
141453|NCT01432977|"     The aim of this study is to demonstrate that the association paracetamol / ondansetron is not     as effective as the association paracetamol / droperidol in the treatment of pain in children     following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine     / codeine) and the cumulated incidence of nausea and vomiting between the two groups of     patients in the first 24 hours after   "
141801|NCT01428414|"     The purpose of the investigators study is to compare the efficacy and safety of combining     trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant     therapy in Chinese HER2-positive breast cancer patients. 100 patients from multicenter would     be randomly assigned into two treatment arms and receive neoadjuvant chemotherapy followed by     operation and adjuvant treatment. The main end point of this study would be the efficacy and     safety of the two treatment arms, and the trend of the two curves is anticipated.   "
141437|NCT01433185|"     Early accurate diagnosis is one of the first crucial steps in care for infants born to     HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early     diagnosis and results in significant reductions in infant morbidity and mortality. There is     little information on evidence-based interventions that specifically target improved     attendance of postpartum clinic visits and subsequent infant HIV testing in the context of     prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose     a randomized controlled trial to examine the effect of text messages sent to women enrolled     in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant     diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses     that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the     postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to     women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks     among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence     to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior     to standard care, the proposed intervention can be easily scaled-up and integrated into     existing healthcare systems in resource-limited settings. Findings from this study will     provide randomized trial evidence to inform HIV prevention program planners and implementers.     This study will also provide further information on the feasibility of using mobile     phone-based technology for public health interventions in resource-limited settings.   "
141438|NCT01433172|"     The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in     combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to     find out if the vaccine and the drugs can boost the immune system of these patients and how     their immune system reacts, both before and after the vaccine treatment.   "
141439|NCT01433159|"     The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care     in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury,     measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.   "
141440|NCT01433146|"     Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity     and influence Survival in Colorectal Cancer Patients   "
141441|NCT01433133|"     This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study.     The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.      All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex     vivo transduced with genetic construct containing the gene for interferon)tissue implants     intended to provide sustained production and delivery of therapeutic levels of INF for up to     twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for     a total of two years post INFRADURE Biopump implantation   "
141442|NCT01433120|"     Studies of the human gut microbiome have suggested that treatment or prevention aimed at the     obese microbiome could influence the development of obesity-associated metabolic     disturbances.      The objective of this project is to explore if a dietary intervention in 60 obese women with     the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut     microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to     explore the interaction between the human genome and the gut microbiome.      The study is based on the following hypotheses:        -  Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed          fibres will lower the metabolic risk profile in the intervention groups compared with          placebo.        -  The effect on the metabolic risk markers can be correlated with changes in the gut          microbiota (measured in faeces).      After completion of the dietary intervention, the participants are offered a 10-week weight     reduction program. Those who participate in the weight-loss program are invited to an     optional follow-up visit in connection with the last visit at the clinical dietician, for the     purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated     metabolic disturbances.   "
141443|NCT01433107|"     This study will compare the efficacy and safety of a single dose of terbinafine film forming     solution 1% with a single dose of placebo film forming solution in the treatment of tinea     pedis.   "
141444|NCT01433094|"     Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders,     with a high impact on disability and participation. Poor adherence to pharmacotherapy     negatively impacts on the course and outcome of PSS.      Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of     relapse and readmission up to 5-time higher than in adherent patients. Falloon et al.     developed a Psychoeducation Program (FPP) aimed at improving communication and     problem-solving abilities in patients and their families. Past studies reported a     statistically significant reduction of the risk of relapse in patients receiving the FPP, but     did not take into account effects on adherence.      Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients     diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another     group exposed to a treatment with generic informative prospects on the disorders provided     with same attendance frequency as the FPP (Generic Treatment - GT).      Methods: 340 patients with PSS, from 10 participating units distributed in the territory of     the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be     randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed     on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure     Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and     concurrently with the administration of a 4-item interview, based on a modified version of     the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method,     followed by Log-rank test, defining as terminal events both the start of non-adherence and/or     the first relapse or readmission episode. Intention-to-treat will be applied in considering     the primary and secondary outcomes. Multiple imputations will be applied to integrate missing     data.      Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already     in contact with a psychiatric service is 47%; effect size of psychosocial treatment on     various outcomes, including relapse, readmission and adherence to drug is 0.48 of the     standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce     a change in the prevalence of non-adherence to drug in the exposed group with an effect size     of 0.45 SD.   "
141460|NCT01432886|"     The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the     tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and     estimate the recommended dose.   "
141462|NCT01432860|"     The almost 724,000 Americans survivors of melanoma are estimated to have 4 first degree     relatives per case; thus, 2.8 million Americans are at increased risk of developing melanoma     in comparison to the general public. Skin self-examination (SSE) with the assistance of a     partner by these individuals could improve survival. If effective, the workbook tested in     this proposal could be distributed to people at risk of developing melanoma by large scale     means in physicians office.   "
141445|NCT01433081|"     A national survey has revealed that 80% of patients experienced pain after surgery and 86% of     these patients had moderate, severe or extreme pain (1).Postoperative pain can extend     recovery room stay after surgery and it is also a common cause of unanticipated admissions     which have important economic implications(2).More importantly, postoperative pain can lead     to a poor quality of recovery in ambulatory patients. The Intraoperative use of medications     that might decrease postoperative pain is therefore highly desirable.      Some medications such as lidocaine and ketamine have been proved to decrease postoperative     pain when given during the Intraoperative period in ambulatory patients(3,4) but it is still     unknown if those medications can in fact lead to a better quality of recovery .      Magnesium sulfate is a non-competitive calcium antagonist at the N-methyl-D- aspartate (NMDA)     receptor(5). NMDA receptors have an important role on pain modulation (6). The use of     Intraoperative magnesium in order to decrease postoperative pain had contradictory results in     different studies. Some studies have shown a potential benefit of magnesium in decreasing     postoperative pain (7,8) while others have not demonstrated any benefit (9,10).      In the ambulatory setting, specifically, Tramer et al. did not find any improvement on     postoperative pain after an Intraoperative dose of magnesium for patients undergoing     ilioinguinal hernia repair(11). Koinig et al., however, demonstrated a significant reduction     in the postoperative analgesic requirements in patients undergoing arthroscopic knee surgery     (12).      Even though, the reduction of postoperative opioid requirement has been used in many studies     in the ambulatory literature, it has been recently questioned by some investigators     (13).Patients might take more opioid medications but they may not necessarily develop opioid     related side effects such as nausea and vomiting. A more global evaluation of the patient     involving several aspects of recovery would be more significant.      The modified quality of recovery 40(MQOR40) is a validated 40 item instrument to assess the     quality of postoperative recovery (14). Myles et al. concluded that the MQOR40 would be a     useful outcome measure to assess the impact on changes in health care delivery (15), but     anesthesia studies underutilize this instrument.      As more complex and painful procedures are being done in the ambulatory setting , the use of     non-opioid strategies to control postoperative pain and to enhance quality of recovery will     have even a greater role in the anesthetic management of patients. Magnesium has not been     established as a potential adjuvant in ambulatory patients with conflicting results of     previous investigators. The main objective of this study is to evaluate if the Intraoperative     use of magnesium have the ability to improve postoperative quality of recovery in ambulatory     patients.   "
141446|NCT01433068|"     RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size     of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and     radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering     surgery more feasible or easier and achieve better local control of the tumor.      PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the     tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.   "
141447|NCT01433055|"     Schizophrenia is a devastating and costly illness. One-third to one-half of people with     schizophrenia do not respond to the most current drugs leaving clozapine as the best     alternative for treatment. However, over 60% of people treated with clozapine continue to     have persistent symptoms and cognitive impairments. Little data is available to support     evidence-based recommendations to guide clinicians in treating these patients. Preliminary     data has suggested that adjunct treatment with minocycline may offer robust symptom     improvement in patients with schizophrenia, including those taking clozapine. Minocycline has     had interesting effects; including suggesting it may have a significant role in treatment of     neurologic and psychiatric disorders. Minocycline is currently available generically; its     side effects are well-described and minimal. The proposed double-blind treatment study seeks     to demonstrate that adjunctive minocycline offers patients superior efficacy for persistent     positive symptoms, cognitive impairments, and/or other components of schizophrenia pathology.     This knowledge could lead to the more effective treatment of patients with schizophrenia. The     research itself may lead to a better understanding of the pathophysiology of positive     symptoms and cognitive impairments, which could contribute to improved treatments in the     future.   "
141448|NCT01433042|"     Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality,     and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps,     which will create more images for evaluation, and therefore should improve diagnostic     accuracy.      Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small     bowel disease.      Preparation for procedure will include 12 hours fasting prior to the capsule ingestion      Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear     liquids 2 hours post ingestion, and eat 4 hours post ingestion.      Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of     capsule performance will be captured   "
141449|NCT01433029|"     The goal of this research study is to develop a method of rating videos of CAB procedures     that will produce a reliable assessment of a cardiothoracic surgical trainee's technical     proficiency. In addition, researchers also want to learn if using a video manual to train     raters can help improve rater reliability.   "
141450|NCT01433016|"     The Exalenz clinical investigation is a multicenter, non-randomized, study of the     ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to     evaluate the capability of the OBT measurement to differentiate between presence and absence     of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.   "
141451|NCT01433003|"     Thrombotic thrombocytopenia purpura / hemolytic uremic syndrome (TTP/HUS) is a rare,     life-threatening disorder. TTP/HUS causes multiple blood clots to form, which prevents blood     from reaching the brain and kidneys. TTP/HUS affects 3-5 people per million per year. Anyone     can develop TTP/HUS, but it is most common among 30-40 year olds, and women are twice as     likely as men to acquire the condition. TTP/HUS sometimes develops as a result of medication     use, pregnancy or cancer; however, for the majority of patients (80%) the cause of TTP/HUS is     unknown. In 1991, researchers discovered that plasma exchange was superior to plasma infusion     in treating idiopathic TTP/HUS. During plasma exchange the patient's blood plasma is removed     and replaced with healthy blood plasma. Without plasma exchange, the survival rate for     TTP/HUS is extremely low, with fewer than 5% of patients surviving. Treating TTP/HUS with     plasma exchange improved the survival rate to 80%. Although this represents a dramatic     improvement, researchers are still searching for methods to improve survival. No major     advances in treating TTP/HUS have occurred in the past 20 years. Recent research suggests     that high-dose plasma exchange may improve the survival of TTP/HUS patients. The     investigators will conduct a randomized controlled trial to test whether treating TTP/HUS     patients with high-dose versus standard-dose plasma exchange improves the treatment response.     The investigators will recruit 150 patients with TTP/HUS from 9 centres across Canada over     three years. The investigators will evaluate whether high-dose plasma exchange improves the     treatment response, survival, and whether it reduces the number and volume of plasma exchange     procedures and duration of hospital stay.   "
141490|NCT01432483|"     The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to     patients who are currently on therapy and who have no other suitable treatment options, where     therapy is requested by their physician.   "
141454|NCT01432964|"     In craniofacial trauma, the involvement of orbital structures is noted in up to 40% of cases     (Ellis 1985). Post-traumatic orbital deformities caused by incorrect reconstruction of     orbital dimensions are severe complications causing enophthalmos, diplopia and visual acuity     disturbance. To prevent such complications, immediate repair of orbital injuries with the     restoration of normal anatomy is indicated in orbital floor fractures. With the help of     biodegradable implants small and medium-sized defects are easily managed (Büchel 2005, Lieger     2010). In extensive fractures however, only calvarian bone and titanium mesh considered to     provide a sufficient support of the orbital content.      Calvarial bone can be difficult to mould and to adapt to the form and size of the orbital     lesion. In addition, donor site morbidity cannot be disregarded. Orbital reconstruction mesh     on the other hand is always available and easier to apply. There are however important     requirements for these meshes, such as biocompatibility, excellent stability, optimal     adaptability and patient comfort. Recently, the company Medartis developed a titanium mesh     featuring a low profile. In order to regain normal function, normal anatomy has to be     re-established. It therefore seemed reasonable to assess an implant, which would facilitate     orbital reconstruction without disturbing normal anatomy by its size, profile height or     properties.      The purpose of this study was to assess the use and accuracy of the low profile titanium mesh     for primary internal orbital reconstruction.   "
141455|NCT01432951|"     The purpose of this study is to assess the pharmacokinetics of enzastaurin and its     metabolites in native Chinese patients with advanced and/or metastatic solid tumors or     lymphoma. Information about any side effects that may occur will also be collected. Treatment     of disease is not the main purpose of the study.      This is a Phase 1 study of enzastaurin in native Chinese patients with advanced and/or     metastatic solid tumors or lymphoma. Patients will receive daily doses of enzastaurin for 14     days, stop dosing for 3 days during PK sampling, and resume dosing on Day 18. Patients may be     allowed to receive enzastaurin for approximately 2 to 4 weeks after day 18 to provide an     opportunity for a patient's oncologist to assess the potential benefit of the patient     continuing to receive enzastaurin in the safety extension phase. There is no planned duration     for the extension phase; patients are allowed to continue receiving enzastaurin until disease     progression or other reason for discontinuation as per the investigator's assessment.   "
141456|NCT01432938|"     Warfarin is a commonly used drug to prevent the blood from clotting. The purpose of this     study is to determine if dulaglutide (LY2189265) affects how warfarin works. The study     involves two different treatments (Treatment 1: warfarin; Treatment 2: dulaglutide +     warfarin) separated by a minimum washout period of 24 days. In Treatment 1, the participant     will receive 10 milligrams (mg) of warfarin on Day 1. In Treatment 2, the participant will     receive a 1.5-mg dose of dulaglutide (LY2189265) as an injection on Day 1 and then a 10 mg     dose of warfarin on Day 3. Participants will be randomly assigned into different treatment     sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2.     Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.   "
141457|NCT01432925|"     SUMMARY      Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic     in West Africa. It often leads to functional limitations. Treatment was by extensive surgery,     until in 2005 gradually antibiotic treatment for eight weeks with rifampicin and streptomycin     was added. Observation of Buruli ulcer lesions of limited size during antibiotic treatment     showed that during treatment there is a paradoxical increase of the lesion, with a decrease     of the lesion after week 14. Current WHO protocols advise to decide whether surgery is needed     four weeks after the start of antibiotics. This might be too early in the healing process.     The investigators hypothesize that delay in surgery is safe, and that it results in a     reduction of the number of surgical interventions.      Objectives:      Primary Objective of this study is to compare the need for surgical treatment in standard     timing of surgery at the end of eight weeks antimicrobial treatment with a policy to postpone     surgical treatment until week 14.      Secondary Objectives are to study whether postponing surgery leads to less extensive surgery     and a change in frequency of functional limitations;      Study design:      Patients will be randomized for surgery at week 8 after start of antibiotic treatment and     week 14 after start of treatment. Reasons for treating doctors to decide to intervene with     surgery will be according to current clinical practice and will be clearly defined in this     protocol. Standard care of eight weeks of rifampicin and streptomycin will be given. All     patients will be followed and lesional size using acetate sheet recordings will be used     during follow-up.      Study population: Patients with a clinical picture of Buruli ulcer disease confirmed by     diagnostic tests in the districts covered by the Buruli ulcer centers in Lalo and Allada,     Benin. Patients who are pregnant, have a contraindication for general anaesthesia and     children below three years old will be excluded. 130 Patients in each treatment arm will be     included to detect a difference in percentage of patients needing surgery of 20 percent.      Main study parameters/endpoints: Primary outcome measure is the number of patients healed     without surgery. Secondary outcome measures are the extent of surgery by measurement of     lesional size, functional limitations after the end of treatment and one year after the start     of treatment and the duration of admission.   "
141458|NCT01432912|"     The purpose of the study is to see if a short seminar educating physicians about smoking     cessation counselling will effectively improve their smoking counselling cessation practices.   "
141459|NCT01432899|"     Background:      - Childhood-onset dystonia is caused by a brain injury. It causes muscle contractions and     twisting movements that the person with dystonia cannot control. The term hemidystonia is     used when only one side of the body is affected. When dystonia starts during childhood, the     brain and nerves may not develop normally. People with hemidystonia can become disabled     because of the unwanted postures and twisting that dystonia causes. More research is needed     to determine how dystonia affects brain development.      Objectives:      - To study brain function in people with hemidystonia.      Eligibility:        -  Individuals between 18 and 40 years of age who developed hemidystonia before age 13.          Only one wrist may be affected by hemidystonia, and participants must have at least some          movement in that wrist.        -  Healthy volunteers at least 18 years of age.      Design:        -  This study requires five visits to the NIH Clinical Center: a screening visit and four          study visits. Each visit will last up to 3 hours. Visits will be scheduled about once a          week. The study procedures may be done in any order.        -  Participants will be screened with a physical exam and medical history.        -  Participants will have the following tests:        -  Brain magnetic resonance imaging scan. During the scan, participants will be asked to          move their hand at the wrist when they hear a tone.        -  Motor tests of arm movement, balance, and walking. These tests may also examine nerve          development and muscle tone.        -  Two transcranial magnetic stimulation sessions to study the electrical activity of the          muscles and brain. These sessions may also involve sensory tests. Participants will have          hearing tests before the first session and after the second session.        -  No treatment for hemidystonia will be provided as part of this study.   "
141461|NCT01432873|"     Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of     mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc     sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis     and positive effects are seen. Our purpose in this double blinded randomized study is to     evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia     (AML) & acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide     before Hematopoietic stem cell transplantation (HSCT).   "
141907|NCT01427023|"     The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical     swab, and cervical specimens collected in PreservCyt Solution (PreservCyt Specimens) for     testing with the APTIMA Trichomonas vaginalis (ATV) Assay.      These specimens will be used to demonstrate assay performance on the PANTHER System is     comparable to performance on the TIGRIS System.   "
141463|NCT01432847|"     Background:      - Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and     Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the     back of the eye. Doctors cannot safely obtain retinal cells to study these diseases. However,     cells collected from hair follicles, skin, and blood can be used for research. Researchers     want to collect cells from people with Best disease, L-ORD, and AMD, and compare their cells     with those of healthy volunteers.      Objectives:      - To collect hair, skin, and blood samples to study three eye diseases that affect the     retina: Best disease, L-ORD, and AMD.      Eligibility:        -  Individuals at least 18 years of age who have Best disease, L-ORD, or AMD in at least          one eye.        -  Healthy volunteers at least 18 years of age.      Design:        -  The study requires one visit to the National Eye Institute.        -  Participants will be screened with a medical and eye disease history. They will also          have an eye exam.        -  Participants will provide a hair sample, a blood sample, and a skin biopsy. The hair          will be collected from the back of the head, and the skin will be collected from the          inside of the upper arm.   "
141464|NCT01432834|"     The purpose of the study was to assess the efficacy of the Allegretto Wave excimer laser and     the wavefront optimized ablation profile in correcting primarily non-anterior astigmatism     faults, following laser in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).   "
141465|NCT01432821|"     The objective of the present study is to assess dopaminergic reactivity with behavioural     markers (i.e. yawning and blinking) in patients with idiopathic generalized epilepsy compared     to matched healthy controls, after injection of either low dose of apomorphine or placebo.      Other parameters will be recorded: biochemical (prolactin, GH) and neurophysiological     (Spike-Waves Discharge: SWD rating). Safety parameters will be recorded to assess tolerance.   "
141466|NCT01432795|"     Medical compression stockings are highly effective in the prevention, treatment, and     secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome.     Non-adherence to the prescribed compression treatment concerns approximately 40% of patients.     Elderly patients are often unable to handle stockings in order to put them on properly in the     morning and to undress in the evening. Gliding aids and stocking butlers are two types of     tools to facilitate the dressing manoeuvre with medical stockings.      The present study evaluates four different gliding aids and two different stocking butlers     to put on three different types of compression stockings. The study is conducted with forty     consenting subjects with advanced chronic venous insufficiency.   "
141467|NCT01432782|"     This study evaluates the effect of botulinum toxin 100 U or saline, injected endoscopically     in the distal esophagus, on symptoms and manometry pattern in patients with diffuse     esophageal spasm.   "
141468|NCT01432769|"     Effect of enteral nutrition in the outcome of patients has the objective to determine the     effect of implementing a nutritional support protocol on the outcome of cardiovascular     surgery patients, the main justification of the study its the prevalence of malnutrition over     the hospitalized patients and the way this complication influence the treatment efficacy, the     risk of complications over these patients, the costs, the prognosis, mortality and hospital     stay.      This study will be a control clinical trial, randomized and double blind.   "
141469|NCT01432756|"     The investigators hypothesize that participants in the worksite parenting program     intervention will show significantly better parent-child communication than will participants     in the no-treatment (wait-list) control group.   "
141470|NCT01432743|"     Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of     ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter     ablation of AF. Integration of a previously acquired image of the left atrium into the     electroanatomical (EA) map offers several potential advantages, including visualisation of     the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results .     The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM,     etc). Although both systems have been independently validated, their clinical utility has not     previously been directly compared in a randomised trial   "
141471|NCT01432730|"     This is a randomised, double-blind, placebo-controlled, crossover, single centre study of     gefapixant (AF-219/MK-7264) in subjects with idiopathic chronic cough designed to evaluate     the effectiveness of gefapixant in reducing daytime objective cough frequency.   "
141472|NCT01432717|"     The purpose of this study is to find out whether ACE-536 can be safely given to patients.     This study will also look to see if ACE-536 increases red blood cells, the cells that carry     oxygen in the body.   "
141473|NCT01432704|"     This is a one-year multi-centre, double blind, placebo controlled, randomized trial     investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b     for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with     interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral     colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin     D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that vitamin     D suppresses clinical and MRI activity of MS.   "
141474|NCT01432691|"     This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint     replacement.   "
141475|NCT01432678|"     The purpose of this study is to evaluate level of vitamin D in pediatric asthma and     relationship between vitamin D and level control of asthma.   "
141476|NCT01432665|"     The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week     baseline establishment period, 16 week treatment period and a follow up period for a total of     26 weeks on study. Subjects are randomly to one of seven treatment arms. The study     investigates the effective dose of Lybrido in increasing the number of satisfactory sexual     episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire     disorder and low sensitivity for sexual cues (30 subjects per group).   "
141477|NCT01432652|"     The purpose of this study is to determine the incidence of aspirin resistance in the     population of vascular surgery patients; and to evaluate the changes in the efficacy of     aspirin in the first five postoperative days.   "
141919|NCT01426867|"     The purpose of this study was to describe the ocular discomfort immediately upon instillation     of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1%     Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with     open-angle glaucoma and/or ocular hypertension.   "
141478|NCT01432639|"     The main purposes of this study is to analyze, in a randomized controlled trial, the effects     of an exercise-based cardiac rehabilitation program (i) on biomarkers of endothelial     function, (ii) on biomarkers of inflammation, (iii) on autonomic function, and (iv) on     arterial stiffness in coronary artery disease patients (CAD). Additionally, the investigators     aim to analyze the (v) contribution of age and the changes in traditional risk factors to the     modification of the endothelial dysfunction and inflammation, and (vi) the contribution of     the changes in inflammatory and endothelial function biomarkers to the modification of     autonomic function and arterial stiffness.      The investigators hypothesize that exercise training will improve the autonomic function,     arterial stiffness and mitigate the endothelial dysfunction and inflammation in CAD patients     even in the absence of significant changes in traditional risk factors. Thus, the     investigators expect with the present study to promote, develop and expand the knowledge in     this field by assessing the impact of exercise on a pool of markers that provide a wide     picture of the pathophysiological processes underlying CAD.   "
141479|NCT01432626|"     Objective: The objective of this pilot study is to characterize the cardiac uptake patterns     of I-123 mIBG in stress-induced (Takotsubo's) cardiomyopathy.      Hypothesis: Perturbations in sympathetic innervation are the underlying pathogenesis of     stress induced cardiomyopathy and will result in abnormalities in I-123 mIBG cardiac imaging.     Thus, planar and SPECT I-123 MIBG imaging will provide insight into the pathogenesis of     stress-induced cardiomyopathy, and may lead to the development of more specific diagnostic     criteria.      Study design: This proposal is for a prospective pilot study to characterize perturbations in     cardiac sympathetic innervation in patients with stress induced cardiomyopathy by performing     planar and SPECT I-123 MIBG imaging during the acute presentation and after recovery of LV     function.   "
141480|NCT01432613|"     Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An     appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a     specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in     departments managing IIM is common. In absence of recommendations fixing their place in the     diagnostic phase, the practices observed are extremely heterogeneous. This practices     diversity well reflects the lack of data in the literature, making it impossible to     appreciate the real contribution of this test. The main aim of this interventional study is     to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity,     predictive positive value and predictive negative value) for patients who are suspected to     suffer from IIM.   "
141481|NCT01432600|"     The main purpose of this study is to see whether pomalidomide can help people with myeloma.     Researchers also want to find out if pomalidomide is safe and tolerable.   "
141482|NCT01432587|"     An ongoing trial of diflunisal has been closed for enrollment, thus, patients suitable for     the study can no longer participate or receive treatment by diflunisal; and patients, who     have participated in the trial can not continue their treatment. The investigators want to     continue to monitor the effect of the drug on transthyretin (TTR) amyloidosis in an open     label observational study.      Primary endpoint will be a composite score of the manifestations of the disease (Kumamoto     scale) and secondary end points will be measurements of neurological impairment, heart     involvement and nutritional status.   "
141483|NCT01432574|"     The purpose of this study is to test the effectiveness of the research study vaccine,     Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human     Papillomavirus [HPV] infection in men (HIM) Study.   "
141484|NCT01432561|"     In order to meet FDA standards of safety and efficacy reporting for most new drugs,     food-effect bioavailability (the impact that the presence of food in the digestive tract has     on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the     site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the     rare disease cystinosis that became available in 1994, but there is inadequate knowledge of     the food-effect on this drug's bioavailability. This study aims to investigate how food     affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.   "
141485|NCT01432548|"     Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause     ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver     disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion)     causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the     ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can lead     to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to protect     the liver parenchyma during liver resection consists of an initial flow clamping for 10     minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad     clamping during transection.   "
141486|NCT01432535|"     This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b     (Sylatron®) in healthy participants to that in participants with moderate to severe     impairment of kidney function.   "
141487|NCT01432522|"     This study is a preliminary report of pharmacokinetic data of epinephrine administered via     intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.   "
141488|NCT01432509|"     The purpose of this study is to identify in prediabetic subjects, physiopathological changes     involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type     2 diabetes risk in this population.   "
141489|NCT01432496|"     The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg     produces better postoperative pain control than Saline nebulization after laparoscopic     colectomy.   "
141551|NCT01431690|"     The primary objective of this study is to determine the effect of Epanova® on the     pharmacokinetic and anticoagulant activity of warfarin.      The secondary objective of this study is to compare the systemic exposure of EPA and DHA     following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a     mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are     likely to be administered to patients with cardiovascular disease who are recommended to     consume low-fat meals.   "
141920|NCT01426854|"     The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is     superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular     inflammation and pain associated with cataract surgery in Chinese subjects.   "
141491|NCT01432470|"     Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning,     itching or discomfort, which often make sex to become difficult or painful. These symptoms     combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue     of the vagina becoming thinner, drier, and less elastic due to the lack of estrogen. In     addition, vaginal atrophy is associated with an increased pH, which creates an environment     more susceptible to infections. The mucosal epithelium shows signs of severe atrophy and     cytological examination demonstrate increased number of the basal and parabasal cells and     reduced number of superficial cells.      Estrogen treatment either as hormone replacement therapy or topical application is a common     treatment for vaginal atrophy. However, some women experience adverse reactions such as     uterine bleeding, perineal pain and breast pain and many women are also reluctant to use     estrogens due to a general negative view to this topic in the society.      Oxytocin is a peptide hormone, which is normally released into the circulation via the     pituitary. The most well known effects of oxytocin are its roles in female reproduction such     as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown to     exert positive effects on the proliferation of human vaginal mucosal cells from     postmenopausal women.      Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation,     topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal     atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from     vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was     applied daily for seven days. The results indicated that for subjects receiving topical     oxytocin the vaginal atrophy assessed by histological examination was reversed after     treatment. A similar effect was not seen in the placebo group, which indicated a difference     between placebo and active treatment. However, the limited number of exposed subjects in this     pilot study necessitates a larger study in order to generate conclusive proof of concept data     for the effects of oxytocin on vaginal atrophy.      Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal     women are left without an effective remedy. Hence, there is a need for alternative     non-estrogenic treatments of this indication. The present study is aiming to investigate the     efficacy of topical oxytocin in the treatment of vaginal atrophy.      The main objective of this study is to investigate if topical oxytocin can reverse vaginal     atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in     postmenopausal women after 12 weeks of treatment as compared to placebo.   "
141492|NCT01432457|"     A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of     desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with     major depressive disorder.   "
141493|NCT01432444|"     The purpose of this study is to compare retrospective hospitalization rates of schizophrenic     patients treated with oral antipsychotics to prospective hospitalization rates of these     patients treated with IM depot aripiprazole.   "
141494|NCT01432431|"     This clinical trial studies spiritual care in improving quality of life of patients,     caregivers, and hospital staff. Spiritual care may help understand the impact cancer and its     treatment has on patients, caregivers and hospital staff.   "
141495|NCT01432418|"     This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the     hypothesis that wheelchair skills training (using a systematic training program called the     Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered     wheelchair users. A second objective is to assess the effects of age, sex, training centre,     and participant experience on outcomes, assessing the retention of benefits and assessing the     impact of training on other important outcomes.   "
141496|NCT01432405|"     The purpose of this study is to examine the effect of exenatide, an anti-diabetes medication,     on liver fat and blood levels of proteins that influence liver fat.   "
141497|NCT01432392|"     The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD)     treatment in primary care setting on symptom control and daily life in symptomatic GERD     patients, using both GERD questionnaire and clinical symptoms assessment   "
141498|NCT01432379|"     This is a post authorization observational study to monitor the utilization practices and     describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of     headaches in adult patients with chronic migraine.   "
141499|NCT01432366|"     It can be assumed that there is a link between what the patient feels and thinks about his     medication and objective measures of disease activity and safety.   "
141500|NCT01432353|"     This multicenter, open-label, dose-escalating study will assess the safety and efficacy of     DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will     receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients     exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to     17 cycles. Anticipated time on study treatment is 1 year or until disease progression or     unacceptable toxicity occurs.   "
141501|NCT01432340|"     Influenza is an important cause of acute respiratory infections (ARI) worldwide. Seasonal     influenza causes an estimated 250,000-500,000 deaths and 3-5 million severe illnesses each     year (WHO, 2009), and pandemic 2009 H1N1 influenza has caused morbidity and mortality     worldwide. In Kenya, influenza accounts for up to 50% of all ARI during the peak influenza     season, based on Kenyan Ministry of Public Health and Sanitation and KEMRI/CDC surveillance     data. Influenza vaccine has been shown to reduce influenza-associated ARIs in developed     countries. However, little is know about the effectiveness of influenza vaccine in the     developing world. In Kenya, a commercial trivalent injectable vaccine is licensed, but less     than 30,000 doses are sold annually. The International Emerging Infections Program (IEIP)     under KEMRI/CDC currently conducts population-based disease surveillance (PBDS) for severe     acute respiratory illness (SARI) and influenza-like illness (ILI) in two sites in Kenya, Lwak     (Nyanza province) and Kibera (Nairobi). The investigators propose to conduct a three-year     influenza vaccine effectiveness study using the commercially available southern hemisphere     seasonal vaccine for 2010, which includes the pandemic 2009 H1N1 component, and for 2011 and     2012. The study will evaluate the effectiveness of the vaccine in preventing     laboratory-confirmed influenza, non-specific ARIs at the clinic and household level, and     secondary influenza infection and secondary ARIs. Our study hypothesis is: Immunizing     children with influenza vaccine will decrease influenza-associated acute respiratory     infections among children and may reduce the number of non-specific acute respiratory     infections in vaccinated children and their household contacts.   "
141502|NCT01432327|"     The aim of the study is to assess an increase of daily physical activity from electronic     self-monitoring, to compare these values to the 10.000 step program, and to compare with     real-time feedback with and without guidance from a Personal Coach.   "
141503|NCT01432314|"     In this study, the investigators are to prospectively evaluate patient's survival, tumor     response, and safety of RT followed by TACE in Child A patients with unilobar portal vein     invasion.   "
141504|NCT01432301|"     The purpose of this study is to provide emergency treatment of adult and pediatric patients:        -  Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms          or        -  Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or          central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g.,          gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of          fluorouracil or capecitabine administration.   "
141505|NCT01432288|"     This study will measure resting state network central nervous system activity by functional     magnetic resonance imaging (fMRI) during 4 separate interactions with a clinician. 1.      Hypothesis 1. Because they are different sensory systems, there will be different patterns of     Mirror Neuron System (MNS)and Resting State Network (RSN) Central Nervous System (CNS)     activity for visual vs. tactile stimulation, regardless of Loving Kindness Meditation (LKM).      Hypothesis 2. Because of unconscious, non-verbal signals, such as the practitioner's facial     expression and respiratory rate, subjects' patterns of MNS and RSN CNS activity will differ     for LKM+ vs. LKM- stimulation for both visual and tactile interventions.      Hypothesis 3. Because there is greater opportunity to detect signals from two sensory systems     than one, the differences between CNS MNS and RSN activity patterns for LKM+ and LKM- will be     greater for combined visual + tactile than for either visual or tactile stimulation alone.   "
141506|NCT01432275|"     The aim of this study is to evaluate user preference and ease of use of the FreeStyle     InsuLinx system, compared to current methodology, when used at home by subjects with     diabetes.      Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with     comparator meters.   "
141507|NCT01432262|"     The purpose of this study will be to assess the safety, tolerability, and immunogenicity of     13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50     years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.   "
141508|NCT01432249|"     Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of     Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication     approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new     indication should be provided at minimum 600 subjects administered in the setting of routine     practice during the initial 4 years after new indication approved.   "
141509|NCT01432236|"     The intent of this study is to identify and treat fibromyalgia subjects with comorbid     depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI     (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine     whether pregabalin demonstrates improvement relative to placebo in improving pain associated     with fibromyalgia.   "
141510|NCT01432223|"     The purpose of this study is to evaluate the efficacy in terms of the pathological complete     response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based     regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable     breast cancer.   "
141511|NCT01432210|"     Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and     vegetables is not active and must be converted to the active form in the human body.     However, information on the ability of humans to absorb and convert vitamin A to the active     form is still lacking. In this study, the investigators will observe the absorption and     conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from     avocado fruit) and a meal without fat. The investigators will also test whether eating these     foods might protect the blood against damage that could lead to heart disease.   "
141512|NCT01432197|"     The aim of this study is to investigate the effect of occupational therapy, in shape of     activities of daily living, for cancer patients.   "
141513|NCT01432184|"     Using the brain and the heart as index organs, perioperative interventions to optimize     cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing cardiac     surgery should have a beneficial systemic effect for enhancing global tissue perfusion and     improve outcomes.   "
141514|NCT01432171|"     The goal of this clinical research study is to learn if an antiepileptic (anti-seizure)     treatment will prevent seizures in patients with brain tumors who have not yet had a seizure.     Anti-seizure drugs are designed to decrease abnormal electrical activity in the brain that     plays a role in developing seizures.      In this study, lacosamide will be used as an anti-seizure medication. Lacosamide will be     compared to a placebo.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     disease or illness. It is designed to be compared with a study drug to learn if the study     drug has any real effect.   "
141515|NCT01432158|"     This is an open-label phase III clinical trial. The purpose of this trial is to investigate     in detail the kinetics of the immune response to Prevenar-13, a pneumococcal conjugate     vaccine, compared to Pneumovax-II, a pneumococcal plain polysaccharide vaccine. With their     consent, healthy adults (n=2 in each group) aged over 18 years who have not received any     pneumococcal vaccine in the past will receive either vaccine at their first visit. Blood will     be taken before vaccination and at day 0,1,2,4,6,8,10,12,14,16,18,20,23,26,30,35 as well as     2,6 and 12 months following vaccination. With specific consent, a small volume of blood will     be used to store DNA and RNA for analysis of the genetic associations with immune responses     and adverse reactions to vaccines as well as the RNA expression following a vaccination.     Serum or plasma will be used to assess antibody level and available whole blood will be used     for B cell assays and to examine immunoglobulin gene usage in B cells.   "
141516|NCT01432145|"     This study will evaluate the efficacy and safety of 6MP in combination with methotrexate in     patients with breast or ovarian cancer who are known to have a BRCA mutation. 6MP is used     instead of 6TG as it is converted to the same cytotoxic moiety as 6TG, ie. thioguanine     nucleotides, but with reduced toxic effects. Low dose methotrexate is used in combination     with 6MP as it promotes the formation of thioguanine nucleotides.   "
141517|NCT01432132|"     The goal of this research study is to understand how patients adjust to appearance and body     image changes after surgery for head and neck cancer.   "
141518|NCT01432119|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of selective internal radiation (SIR)-Spheres with yttrium-90 attached and     cetuximab. Some participants will also take erlotinib with this combination.      Yttrium-90 microspheres are designed to treat cancer that has spread to the liver.     SIR-Spheres are designed to deliver the radiation directly to the liver. This radiation may     cause the tumor cells to die.      Cetuximab and erlotinib are drugs that are designed to block the epidermal growth factor     receptor (EGFR). EGFR is a protein that helps cancer cells grow. Blocking the EGFR may stop     tumors from growing.   "
141811|NCT01428284|"     The purpose of this study is to assess the effects of multiple doses of probenecid on the     multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers.     Safety and tolerability will also be assessed.   "
141519|NCT01432106|"     Study purpose: African Americans with hypertension and markers of metabolic syndrome (small     elevations in blood glucose, triglycerides and or weight) are at a high risk of     cardiovascular (heart and blood vessel) problems. There is a circulating factor called     angiotensin II that increases risk and may be more important in African Americans who have up     to 20 times greater risk of losing kidney function and requiring dialysis. Research     Investigators, including those at the University of Michigan, found one drug (Ramipril) that     blocks angiotensin II effects significantly and improves kidney function in African     Americans.      The purpose of The SAAVE Study is to determine whether the combination of two new blockers     (Valsartan and Aliskiren) of angiotensin II, are better able to lower blood pressure, also     improve some of the risk factors for cardiovascular problems and provide greater protection     to the heart and kidneys.   "
141520|NCT01432093|"     Most people develop high blood sugars following liver transplant that requires treatment with     insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid     medications. High blood sugar levels can be treated with a hormone that the body makes called     insulin. This study is being done to determine if maintaining normal blood sugar levels after     transplant for as long as needed while in the hospital results in a lesser incidence of     death, infections, transplanted liver rejection or failure or need for rehospitalization     within 90 days after transplant.   "
141521|NCT01432080|"     For many patients with blood cancers, stem cell transplantation from a family member or from     an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of     patients develop chronic lung disease after the transplant, which substantially increases the     risk of death in the long-term. Currently, patients with transplant-related lung disease are     treated with some combination of steroids and other immunosuppressant drugs, but only about 1     out of 5 improve.      The importance of our study is that the investigators aim to prevent the development of     transplant-related chronic lung disease in the first place. Because a strong risk factor for     such chronic lung disease is a prior viral respiratory tract infection, the investigators     think there is a window of opportunity to intervene. As soon as cold and flu symptoms     start, the investigators will treat patients with a combination of drugs aimed at eliminating     damaging immune responses triggered by the virus. In the absence of such treatment, the     investigators believe these lung-damaging immune responses would persist even after the virus     disappears. Our hope is that preventive treatment might avoid the development of chronic lung     disease, and this would substantially increase long-term survival in our transplant patients.      This is a pilot study. Once feasibility is established, the investigators will seek to expand     this study into a definitive clinical trial.   "
141522|NCT01432067|"     The investigators will propose to older cancer patients with good prognosis (curative care) a     randomized trial of adapted physical activity during one year. To increase generalisation of     the intervention the investigators intend to compare the PNNS advices (the French National     Nutrition and Health Program) to a program targeted on the own capacities of each patient.   "
141523|NCT01432054|"     The objective of this study is to create a Human Tissue Repository to be used as a resource     for future tissue repair research at KCI USA, Inc.   "
141524|NCT01432041|"     Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention     program which was conducted in the waiting area of a level 1 pediatric trauma center. A     computer kiosk was used to randomly assign participants to study groups, collect baseline     data and generate tailored reports based on responses to assessment items. An intervention     group received a personalized and stage-tailored safety report and a control group received a     personalized, but otherwise generic report on other child health topics. Telephone follow-up     interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home visits were     completed for a subset (n=100) of parents who completed the 4-6 month follow-up interview.     The study aimed to increase knowledge, self reported and observed safety behaviors.   "
141525|NCT01432028|"     This is cross-over, randomized clinical trial, with objective to evaluate the effects of     low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers     (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on     anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women     and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms      Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment      The investigators hypothesis is that a different genotypes in the receptor estrogen gene and     FTO may have an influences on treatment response in metabolic markers and cardiovascular risk   "
141526|NCT01432015|"     Nausea and vomiting are two of the more concerning adverse outcomes associated with     chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer     patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with     carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and     vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining     a cancer patient's quality of life.   "
141527|NCT01432002|"     The purpose of the study is:        -  to assess the potential benefits of 18F-[FDG] PET/CT and PET/MRI for operable breast          cancer in order to define the size and location of the primary tumor, as well as          axillary, supraclavicular and internal mammary lymph nodes.        -  to apply the imaging results to the simulation and the radiation treatment planning and          partial breast for 3-D radiation treatment and partial breast irradiation with intensity          modulated radiation treatment (IMRT).   "
141528|NCT01431989|"     This study is prospective, open-label, randomized, crossover, single dose, with 02     treatments, 02 sequences and 02 periods. The volunteers received, in each period, the     reference or the test formulation, according to the randomization list, under fasting     conditions, in order to evaluate if the reference and test formulations are bioequivalent.   "
141537|NCT01431872|"     The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to     peak, then decrease gradually as estrogens reach a new lower, but steady level. The     investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion     from the osteoblastogenic pathway to the adipogenic pathway.      The investigators will conduct a longitudinal cohort study of post menopausal women with     hormone-responsive breast cancer that will be treated AIs. The study will observe     anthromorphic and serum marker changes during the first year of their treatment.   "
141529|NCT01431976|"     This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety of     lamotrigine monotherapy on newly diagnosed typical absence seizure in children and     adolescents in Japan and South Korea.      The study period is composed the baseline, fixed escalation phase, escalation phase,     maintenance phase, taper phase, and post study examination. During the fixed escalation     phase, the investigational product is administered at 0.3 mg/kg/day for 2 weeks (Week 1 to     2), followed by 0.6 mg/kg/day for 2 weeks (Week 3 to 4). Subjects thereafter visit the clinic     once every 1 to 2 weeks during the escalation phase to increase the dose by 0.6 mg/kg/day up     to a maximum of 10.2 mg/kg/day or 400 mg/day (whichever was less) until patients are     confirmed to be seizure-free by HV tests for clinical signs. After seizure free is confirmed     by HV-clinical signs, the dose is increased by one level and HV-EEG (electroencephalography)     test (first test) is assessed at the next visit. If seizure free is observed by HV-EEG, the     same dose is administered. Thereafter, HV-EEG (second test) is assessed at the next visit and     if seizure free is confirmed again, the subjects enter the 12-week maintenance phase. During     the maintenance phase, patients visit the clinic once every 4 weeks. The dose can be adjusted     as necessary within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day (whichever was less)     taking into account the status of seizures and the safety. The investigational product is     administered once daily (in the evening). However, if the number of tablets is large,     twice-daily administration (in the morning and evening) is also allowed. After the completion     of maintenance phase, subjects who have responded to lamotrigine without tolerability issues     are eligible to enter the extension phase of the study if clinically indicated.   "
141530|NCT01431963|"     This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to     evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed     epilepsy and those with recurrent epilepsy (currently untreated).      The study is composed of baseline, escalation phase, maintenance phase, taper phase and post     study examination. During the escalation phase, the investigational product is administered     orally at 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks and finally 100 mg/day for 2     weeks. During the maintenance phase, 200 mg/day is administered orally for 24 weeks. However,     the dose can be decreased to 100 mg/day if there are safety concerns. Also, if it is     confirmed that the seizures cannot be controlled at the dose of 200 mg/day, the dose can be     gradually increased up to 400 mg/day by 50-100 mg/day at intervals of at least 1 week. As a     rule, lamotrigine should be administered once daily (in the evening), but the dose exceeding     200 mg/day can be administered in two divided doses (in the morning and evening). After the     completion of maintenance phase, Japanese subjects who have responded to lamotrigine without     tolerability issues are eligible to enter an extension phase of the study if indicated, until     either approval of this indication (monotherapy in epilepsy) or after 24 months after LSLV     (Last Subject's Last Visit) of the maintenance phase, whichever is sooner.   "
141531|NCT01431950|"     A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two     doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and     adolescents currently receiving mid to high strength inhaled corticosteroids.   "
141532|NCT01431937|"     The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     repeat ascending doses of GSK2018682. The study will also provide further evidence of the     potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute     Lymphocyte Counts (ALC).   "
141533|NCT01431924|"     This is an observational retrospective analysis of linked pharmacy and medical claims data     from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States     (US) healthcare claims database that is representative of the non-elderly, insurance-carrying     population, The total population is 35.4 million. The average length of follow-up is 2.7     years mean (2.2 years median).      Subjects will be identified in the database that have at least one ICD-9 diagnostic code     (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the     index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids.     Subjects will be followed in the database until they have the event of interest     (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or     combination of asthma-related emergency department/hospitalization or asthma-related     emergency department/hospitalization/oral corticosteroids) or until they are lost to follow     up whichever comes first. Subjects can be censored if they leave the database, have the event     of interest, or are dispensed another asthma controller other than the medication of     interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical     models adjusting for differences in baseline (pre-index) asthma and patient demographics will     be used to compare asthma events.   "
141534|NCT01431911|"     The timing of initiating short-term treatment for COPD exacerbations with oral     corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of     exacerbations with early initiation of exacerbation therapy having a faster symptom recovery     compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are     crucial for immediate exacerbation therapy, maintenance therapy with controller medications     for COPD has been recommended to reduce the risk of future exacerbations. The initiation of     maintenance therapy after a COPD exacerbation has been shown to be beneficial in the     reduction of risk of future exacerbations. However, there is a lack of information on whether     the timing of this initiation influences the risk of future exacerbations. The following     study evaluates the impact of early versus delayed initiation of controller medication     therapy for maintenance treatment following a COPD-related exacerbation on outcomes of future     exacerbations and costs in patients with COPD.   "
141535|NCT01431898|"     This is a research study to evaluate the safety, tolerability and anti-viral activity of     GS-9669 in patients with Hepatitis C infection.   "
141536|NCT01431885|"     Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical     length to diagnose preterm labor can result in improved outcomes compared to traditional     diagnosis based on digital examination to measure cervical change.   "
141550|NCT01431703|"     It exists a learning curve in using NBI with magnification to differentiating colorectal     lesions.   "
141822|NCT01428141|"     The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK),     pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to     patients with advanced solid tumor and gastric cancer.   "
141538|NCT01431859|"     Birch pollen allergy is increasingly common. It causes asthma and early season hay fever.     This is because the body recognises birch pollen and reacts to it, leading to symptoms. Many     patients with birch allergy get an itchy and/or swollen mouth when they eat fresh fruit     (apples, pears, peaches, plums etc). Some fruit proteins have a similar structure to birch     pollen; because of this the body recognises these proteins too causing the immune system to     respond. This response causes symptoms of itch and swelling inside the mouth and throat. the     investigators want to find out whether it is possible to get rid of the fruit-induced     symptoms by using a desensitisation procedure that has been developed for treating the kind     of hay fever that is caused by birch pollen. Desensitisation involves giving a small     injection of pollen just under the skin and gradually increasing the amount each week. This     allows the body to build up a tolerance to the injected protein. When the pollen is then     encountered in real life the immune system reacts less vigorously so symptoms are less     severe. This treatment does reduce hay fever symptoms. Our study aims to find out if this     tolerance is transferred to the fruit proteins enabling patients to eat apples with minimal     symptoms. Patients will be given apple to eat in a hidden form before treatment and their     response assessed. They will then receive either active or dummy pollen injections before     birch pollen season. A few months after completing these injections they will have another     disguised apple test to see whether their symptoms are any better. If symptoms have improved     with treatment then this therapy could be offered to patients in the future. This would allow     them to eat fresh fruit without worrying about unpleasant symptoms and improve their hay     fever symptoms.   "
141539|NCT01431846|"     The study had three parts:      Part 1: Patients (or their home caretakers) who live outside of Denver and receive their     primary care at a location other than the Denver VAMC were interviewed after their discharge.     The interview covered the patient's perspective about the transition of their medical care     from the Denver VA to their primary care facility.      Part 2: Primary care providers from the VA facilities that refer patients to the Denver VA     were interviewed regarding their opinions of transition process from the Denver VA back to     the primary care VA facilities.      Part 3: The data from the above interviews were used to develop an intervention to improve     the transition process from the Denver VA back to the primary care VA facilities.   "
141540|NCT01431833|"     Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic     impairment versus matched control subjects with normal hepatic function.   "
141541|NCT01431820|"     The purpose of this study is to determine the safety and efficacy of a topical antifungal     formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the     toenails.   "
141542|NCT01431807|"     To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.   "
141543|NCT01431794|"     This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine     and nab-paclitaxel with an oral hedgehog inhibitor LDE225. The objective is to assess     tolerability and the resection rate of patients with borderline resectable pancreatic     adenocarcinoma who use this treatment.   "
141544|NCT01431781|"     Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde     Cholangiopancreatography), the incidence rate is 5&-10%, how to prevent PEP and     hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas     treatment. In order to explore the effects of somatostatin on prevent PEP(post-ERCP     Pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given     common treatment, the other uses somatostatin in the base of common treatment.   "
141545|NCT01431768|"     This is a open label, prospective, pair comparison, randomised, multi-centre trial. The     primary aim of this study to is to clinically validate the sensitivity and specificity of the     Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available     rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for     identifying Influenza A infection Polymerase Chain Reaction (PCR).      The secondary aim is to clinically validate the sensitivity and specificity of the Respirio     Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.   "
141546|NCT01431755|"     The objectives of this study are to evaluate the pain-relieving effect and safety of adding     lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained.     The study products will be administered in the cheek.   "
141547|NCT01431742|"     This is an open label study of up to approximately 52 weeks duration to assess the safety and     effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back     pain.      BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine     hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic     opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled     substance in the United States.   "
141548|NCT01431729|"     Although, oral mucositis has been studied for many years, no available treatment has been     shown to be effective in preventing or treating mucositis. Based on the observations that     honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial     and wound healing effects, the present study aims at evaluation of the effect of topical     application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as     natural products, in treatment of chemotherapy-induced oral mucositis in children with acute     lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which     eligible patients were randomly assigned into three equal treatment groups. Group 1 received     15 gm honey applied topically to the affected oral mucosa three times daily. Group 2 received     5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied topically     to the oral mucosa three times daily. Group 3 served as control and received a 7.5%     benzocaine gel applied to the areas of ulcers three times daily.   "
141549|NCT01431716|"     This study is investigating the effect of switching from Flolan® to Epoprostenol for     Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated     with Flolan®. For this purpose patients being treated for at least 12 months with Flolan®     will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90     days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated     patients. This 90 follow-up will provide clinical evidence on the safety, tolerability,     efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients     with pulmonary arterial hypertension.   "
141552|NCT01431677|"     Background:      - In individuals as they age, changes in muscle tissue can significantly affect their muscle     strength and exercise endurance. This process, known as sarcopenia, may lead to decreased     mobility and physical weakness, which is what we in general refer to as frailty. The causes     of sarcopenia and why it affects some individuals more than others are not known, but many     factors influence muscle physiology and function, including metabolic, hormonal,     environmental, and lifestyle factors. Researchers interested in identifying factors involved     in the start and progression of sarcopenia need of samples of human muscle tissue and cells     for laboratory investigations.      Objectives:        -  To train researchers in the appropriate procedures for performing muscle biopsies and          collecting, labeling, and storing the samples.        -  Develop a data base of specific scientific studies evaluating the physiological and          metabolic function of muscle that can be used in future studies.      Eligibility:      - Healthy volunteers at least 18 years of age.      Design:        -  Participants will be screened with a full medical history and physical examination, as          well as blood and urine tests, and will schedule a date for the muscle biopsy.        -  Participants will have a muscle biopsy, with tissue and cells taken from the upper part          of the thigh. A local anesthetic will be given for the procedure. Participants will also          provide a blood sample and have an electrocardiogram to evaluate heart function.        -  Participants will have a followup visit 1 week after the biopsy visit to evaluate the          healing process and provide any further treatment for the affected area, after which          they may fully resume normal activities.   "
141553|NCT01431664|"     RATIONALE: AT9283 may stop the growth of cancer cells by blocking some of the enzymes needed     for cell growth.      PURPOSE: This phase I/IIa clinical trial is studying the side effects and best dose of AT9283     in treating young patients with relapsed or refractory acute leukemia.   "
141554|NCT01431651|"     Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the     only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the     leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight     loss and resolution of metabolic co-morbidities in morbidly obese patients .      However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass     like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine     whether probiotics would improve annoyed GI symptoms after gastric bypass.      Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial     microorganisms found in the human gut. They are also called friendly bacteria or good     bacteria. Probiotics are available to consumers mainly in the form of dietary supplements     and foods.   "
141555|NCT01431638|"     This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety     and tolerability in patients who have frequent flares of acute gouty arthritis.   "
141556|NCT01431625|"     AIM: To identify those mechanisms involved in the systemic and muscular response to exercise     treatment, in two different Obstructive Chronic Pulmonary Disease (COPD) phenotypes     (emphysema and non-emphysema). The investigators will evaluate the effect of exercise     training, on exercise outcomes, peripheral muscle strength measures, dyspnea and quality of     life indices, and markers of systemic inflammation and muscle repair.      SUBJECTS: The investigators will study 30 COPD patients in GOLD II-IV stages, with     symptomatic disease. Patients will be differentiated into 2 different phenotypes:     predominant-emphysema and non-predominant emphysema (15 subjects for each group), according     to high resolution computed tomography (HRCT) scanning images, and after the specific     analysis with the MeVisPulmo software. After patients are typified, they will be included in     the 12- wk training programme. MEASURES(pre&post-training):Basic blood analysis, EKG,     spirometry, blood gases, pletysmography, gas diffusion, maximal inspiratory and expiratory     pressure (MIP,MEP), bioimpedanciometry, 1RM test and isometric strength determination, 6-min     walking test (6MWT), maximal and submaximal cycle-ergometry, and dyspnea using the Mahler's     Basal and Transitional Dyspnoea Indexes (BDI/TDI) and quality of life (Chronic Respiratory     Disease Questionnaire [(CRDQ]) evaluation. Besides, the investigators will measure blood PCR     and cytokines levels (IL6, IL8, IL10, IL12, TNF-α, IGF-1, and MIC-A & MIC-B). Muscle biopsies     will be made (quadriceps) for detection of TNF-α, TNFR-I, TNFR-II, IGF-1Ea and MGF, IGF-1R,     genes bound to biogenesis, markers of cell lesion-stress and myosin heavy chains (MyHC) type     I and II, N-CAM/CD56 and Met & Desmin   "
141557|NCT01431612|"     The aim this study was to examine to what degree the slow turnover of lactated Ringer's     solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor     blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed     under intravenous anesthesia.   "
141558|NCT01431599|"     The purpose of this study is to evaluate the early clinical outcome of the short-course     preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the     investigators initiated the clinical trial of KROG 11-02.   "
141559|NCT01431586|"     This is the first study to be conducted in humans for JDTic, a new chemical entity, with     evaluations focusing on the safety, tolerability, and pharmacokinetics (PK) of JDTic     following administration of single oral doses. JDTic is a novel, selective κ opioid receptor     antagonist and is currently being developed by RTI International as a potential     pharmacotherapy to treat cocaine dependence. This study has the possibility of identifying     the maximum tolerated dose in humans and a surrogate measure of JDTic pharmacodynamic (PD)     activity. Data from this study will be used to plan for and define dose ranges for subsequent     studies, as well as to identify potential indicators of JDTic pharmacological activity.   "
141560|NCT01431573|"     This pilot study seeks to replicate previous findings that sleep deprivation results in     marked improvement in depression symptoms, as well as to test whether concurrent treatment     with Light Therapy and Lithium are successful in locking in and maintaining therapeutic     effects in both bipolar and unipolar depressed subjects.   "
141561|NCT01431560|"     The purposes of this study are to compare the outcomes of the biodegradable implants for the     fixation of ankle fracture and those of metallic implants, and to assess the problems of the     biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate     and screws for ankle fracture are not different from those of metallic implants.   "
141939|NCT01426607|"     This is a randomized controlled study evaluating the impact of 2 months of oral appliance     therapy on endothelial function in patients with severe obstructive sleep apnea syndrome     intolerant to continuous positive airway pressure (CPAP) therapy.   "
141562|NCT01431547|"     This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for     pediatric participants with advanced solid tumors. This study will have three parts. Part 1     will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for     dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination     with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD)     found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination     therapy.   "
141563|NCT01431534|"     This is a study to find a maximum tolerated dose (MTD) and pharmacokinetic (PK) data for     ridaforolimus given to participants between the ages of 6 and 17 years with advanced solid     tumors.      Study-related visits concluded in August 2013. Participants may continue treatment until they     meet discontinuation criteria or voluntarily withdraw.   "
141564|NCT01431521|"     This study will evaluate changes in liver fat content following multiple oral doses of     MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease.     The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg     twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo     in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction     in hepatic fat with respect to placebo is expected).   "
141565|NCT01431508|"     This study is being conducted to evaluate the safety and antihypertensive efficacy of     MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to     moderate essential hypertension.   "
141566|NCT01431495|"     This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients     with coronary disease:        -  Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg          loading dose or after the last maintenance dose (75 mg).        -  Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events          (MACE).        -  Safety Criteria: severe bleeding (GUSTO scale).   "
141567|NCT01431482|"     This study is an evaluation of the composition of human milk and health outcomes in children.   "
141568|NCT01431469|"     The purpose is to determine if the consumption of study product has an effect on acute     respiratory infections and/or diarrheal disease.   "
141569|NCT01431456|"     Rationale:      After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous     thromboembolism (VTE) or deep venous thrombosis (DVT) potentially resulting in a fatal     pulmonary embolism (PE). Two novel agents, dabigatran and rivaroxaban, recently gained market     authorisation for prevention of venous thromboembolism after knee arthroplasty.      However, there are no clinical trials with dabigatran and/or rivaroxaban and the comparator     nadroparin.      Nadroparin is used in the most Dutch departments of orthopaedic surgery after total knee     arthroplasty. Also safety of the new oral agents with long term use of 42 days is not     available for total knee arthroplasty.      Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on     safety after total knee arthroplasty (TKA) in a clinical explorative pilot study by observing     the incidence of major bleeding and clinical relevant non-major bleeding using a standardized     model of bleeding definitions.      Objective:      The primary objective of this study is to compare the clinical safety with long term use of     the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus     subcutaneous administered nadroparin by observing the incidence of major bleeding and     clinical relevant non-major bleeding in patients after knee arthroplasty surgery.      The secondary objectives of this study are effectivity of the agents, compliance, hospital     stay, re-hospitalisation, outpatient clinic visits and interventions following complications.     Additionally, coagulation monitoring, knee flexion range of motion, Knee injury and     Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS) and relationship between health     statuses and surgery parameters will be evaluated.      Study design:      The study is designed as non-inferiority randomized open label controlled pilot study. A     total of 150 patients will be included, 50 patients in each treatment group (dabigatran,     rivaroxaban and nadroparin).      Study population:      Patients ≥ 18 years and weighing more than 40 kg, participate in the 'joint care program' for     primary elective total knee arthroplasty and want to provide signed informed consent are     eligible for the study.      Intervention:      Patients receive subcutaneously nadroparin or oral rivaroxaban or oral dabigatran after knee     replacement surgery.      Main study parameters/endpoints:      The primary safety outcome is the incidence of bleeding events occurring during the study     period of 135 days (including follow-up). Major bleeding events and clinically relevant     non-major bleeding events were defined according to accepted guidelines.   "
141570|NCT01431443|"     The purpose of this study is to investigate the acute and chronic effect of consumption of     flavanol-rich chocolate on endothelium function in pregnant women at high risk for     preeclampsia.   "
141571|NCT01431430|"     It has been proposed that the intake of high dose of cholecalciferol may have beneficial non     classical effects (beside bone health). This could include the reduction of type 2 diabetes     mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These     pleiotropic effects are mostly documented by observational and experimental studies or small     intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as     circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this     population is at risk of the previously cited complications.The primary purpose of this study     is to compare the effects of high dose vs. low dose of cholecalciferol on a composite     endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and     patient death.Renal transplant recipients between 12 and 48 months after transplantation will     be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up     of 2 years.   "
141572|NCT01431417|"     A lot of shoulder function evaluation scores exist but none has been universally accepted as     a gold standard.      Recent studies have demonstrated the potential of computerized movement analysis with     embedded sensors for objective evaluation of shoulder functional outcome following surgery.      A very simple testing procedure is possible as just a few repetitions of two simple shoulder     movements are sufficient. This could potentially facilitate implementation of shoulder     function movement analysis in current clinical practice.      However, at the present stage of development, the method needs to be extensively validated.     This means that the research will intend to determine precisely for which current shoulder     pathology it can be applied, what the outcome of healthy people is, what the reliability of     the score is and how it can monitor patient evolution.   "
141573|NCT01431404|"     The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203     liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.   "
141574|NCT01431391|"     The main purpose of this study was to determine whether ADT started before or after     sipuleucel-T led to a better immune system response. This study also evaluated the safety of     sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of     sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.   "
141575|NCT01431378|"     This study is being performed to confirm that the new technique, Model-Based Iterative     Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT     scans compared to current techniques (Filtered Back Projection with Adaptive Statistical     Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve     general image quality characteristics at equivalent radiation dose levels.   "
141577|NCT01431352|"     This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory     Chinese women with PCOS will be recruited, and the randomization will be stratified by each     participating site. Participants will be randomized into one of the two treatment arms:     letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a     day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual     cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to     5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of     the present study is to determine the efficacy of combined treatment with letrozole and CHMG     on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that     the combination of letrozole and CHMG is more likely to increase the ovulation rate and     decrease the miscarriage rate and result in a higher live birth rate in PCOS women than     letrozole alone.   "
141578|NCT01431339|"     The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)     of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral     linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial     skin or skin structure infections.   "
141579|NCT01431326|"     Understudied drugs will be administered to children per standard of care as prescribed by     their treating caregiver and only biological sample collection during the time of drug     administration will be involved. A total of approximately 3000 children aged <21 years who     are receiving these drugs for standard of care will be enrolled and will be followed for up a     maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of     understudied drugs for which specific dosing recommendations and safety data are lacking. The     prescribing of drugs to children will not be part of this protocol. Taking advantage of     procedures done as part of routine medical care (i.e. blood draws) this study will serve as a     tool to better understand drug exposure in children receiving these drugs per standard of     care. The data collected through this initiative will also provide valuable pharmacokinetic     and dosing information of drugs in different pediatric age groups as well as special     pediatric populations (i.e. obese).   "
141580|NCT01431313|"     This is a single-center, open label phase II study to evaluate the effect of inhaled nitrite     delivered in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in     subjects with pulmonary hypertension undergoing right heart catheterization.      A total of 50 subjects with a confirmed diagnosis of pulmonary hypertension and meet all     inclusion/exclusion criteria will be enrolled in the study which will entail a single right     heart catheterization and nebulized nitrite dose of 45mg with one subsequent dosage of 90 mg.   "
141581|NCT01431300|"     The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography     of the central veins of the chest, and to determine whether dose reduction can be performed     while maintaining image quality. This will be a prospective randomized study, in which     healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram     (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar.     Quantitative and qualitative analysis will be performed on the images.   "
141582|NCT01431287|"     The overall objective of this study is to assess the efficacy and safety of 52 weeks once     daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT     Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the     RESPIMAT Inhaler) in patients with COPD.   "
141583|NCT01431274|"     The overall objective of this study is to assess the efficacy and safety of 52 weeks once     daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT     Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the     RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).   "
141584|NCT01431261|"     The purpose of this study is to test whether a physiotherapy intervention containing pain     management, general training and specific neck exercises can improve function for patients     with chronic neck pain.   "
141585|NCT01431248|"     Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or     azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in     stomach upset in some patients, causing them to stop taking the medication. Therefore,     azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach     upset is not seen or greatly reduced. The goal of this study is to see if there is a     difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in     prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The     working hypothesis is that there is no difference in the clinical effectiveness between     antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging     latency in PPROM.   "
141586|NCT01431235|"     The purpose of this study is to determine if cognitive behavioral therapy is effective in     treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.   "
141587|NCT01431222|"     The primary objective in this randomized trial is to evaluate the safety and efficacy of a     MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to     the previous default medical treatment - in a study population who is not amenable for the     conventional surgical approach as current gold standard.   "
141588|NCT01431209|"     This phase II trial studies how well ruxolitinib phosphate works in treating patients with     diffuse large B-cell or peripheral T-cell non-Hodgkin lymphoma that has returned (relapsed)     or that does not respond to treatment (refractory) after donor stem cell transplant.     Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes     needed for cell growth.   "
141599|NCT01431066|"     Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals     in the workplace who must stand for prolonged periods of time, and athletes. It can be     disabling. There is no single accepted treatment course that is recommended in the     literature.      The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a     treatment option in chronic soft-tissue injury due to its ability to reduce pain and     inflammation.      The proposed study will investigate the efficacy of the use of a PRFE device for the     treatment of chronic heel pain using a double blind randomized placebo controlled design     study.   "
141600|NCT01431053|"     This is a phase II study to assess efficacy/safety of Exemestane with or without Aspirin as     the adjuvant treatment in postmenopausal breast cancer patients.   "
141589|NCT01431196|"     Molecular expression in breast cancer (BC) defines special fenotypes with different     prognostic and predictive features.Since the addition of trastuzumab and lapatinib to     chemotherapy, HER2 overexpressing tumors have become the best responders to systemic     therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative     tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A)     or early distant relapse after diagnosis (triple negative BC) . In this open, prospective,     non-randomized and multicentric phase II study the investigators include stage II and III     HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy     Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with     autologous dendritic cells pulsed with their own tumor. The hypothesis is that the     reinforcement of the immune system with the autologous dendritic cell vaccination against     HER2 negative BC could increase pathologic complete responses (pCR) and disease free     survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance     schedule.   "
141590|NCT01431183|"     The objective of this study was to assess the feasibility and effectiveness of using a     statewide immunization information system (IIS) to send seasonal influenza vaccine reminders     from Local Health Departments (LHDs), targeting children with high-risk conditions.   "
141591|NCT01431170|"     The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic     suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The     hypothesis of the study is that Besivance™ is as safe and effective as the current standard     of care for the treatment of nasolacrimal duct obstruction in children.   "
141592|NCT01431157|"     Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and     symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the     level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness,     hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias,     pulmonary hypertension, heart failure, and premature death. There is significant evidence     suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of     the abnormalities associated with this disease.      Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. Mild     sleep apnea is present in 17% of adults in the general population and moderate to severe     sleep apnea is present in 5.7% of adults. Among patients with heart failure the prevalence     skyrockets. Multiple studies have found the prevalence of moderate to severe sleep apnea to     be anywhere from 11-53% in heart failure patients.      Continuous positive airway pressure (CPAP) therapy is currently the standard of care for     sleep apnea sufferers regardless of the severity of their disease. In patients without heart     failure, CPAP therapy has numerous benefits and several long term studies have reported that     CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular     symptoms and mortality among patient with severe sleep apnea.      In heart failure patients, CPAP has shown some beneficial short term effects but evidence of     long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy     reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and     increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival     or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is     often poor and many people cannot tolerate it. This further limits the therapeutic     effectiveness of this intervention.      The purpose of this study is to assess whether nocturnal oxygen administration via nasal     cannula alone can improve outcomes in congestive heart failure patients with moderate to     severe sleep apnea. The effects of nocturnal oxygen administration will be assessed by using     biomarkers of heart stress and markers of whole body inflammation.   "
141593|NCT01431144|"     This study is a comparison of implant placed and simultaneously grafted with either     autogenous connective tissue or a connective tissue allograft. The objective is to determine     the change in soft tissue thickness and determine if a better result is obtained with the     autograft or the allograft. The hypothesis is that there will be no difference in soft tissue     thickness over the implant between the autograft and the allograft technique.   "
141594|NCT01431131|"     The purpose of this study is to compare two methods of ridge preservation in the maxillary     anterior esthetic zone to determine the best method to establish adequate bone and soft     tissue to accommodate implant placement. For the positive control group a mineralized     cancellous allograft will be placed in the extraction socket. For the test group a     mineralized cancellous allograft will be placed in the extraction socket plus an additional     graft will be placed to overlay the facial surface of the socket that will be composed of     bovine xenograft material. Outcomes will be clinical horizontal and vertical dimensional     change and histologic analysis of the graft material at 4 months post-placement.   "
141595|NCT01431118|"     The purpose of the study is:        -  To investigate the effect of sport-specific stress in the iron metabolism of dragon boat          athletes        -  To investigate the effects of sport-specific stress in the activity of pro-hepcidin and          hepcidin   "
141596|NCT01431105|"     Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the     developed world. Despite available treatment, 25% of children in San Diego County     appropriately treated for KD develop coronary artery abnormalities that could lead to     complications later in life, including heart attack. Although investigators can identify     children with KD that have these coronary artery abnormalities, there is no approved     additional treatment to decrease coronary artery inflammation and arrest or prevent damage to     the coronary arteries. Inflammation and damage to the arterial wall is central to these     coronary artery abnormalities. Statins, a class of drugs that is known for lowering     cholesterol, have also been shown to decrease inflammation in general as well as at the level     of the vessel wall. Therefore, the investigators propose to study the safety of the drug     atorvastatin in children with coronary artery abnormalities from KD.   "
141597|NCT01431092|"     In this trial, researchers aim to investigate if prolonged-release melatonin can facilitate     the withdrawal of chronic benzodiazepine administration in patients with schizophrenia.     Furthermore, researchers will investigate the association of benzodiazepine dose reduction     with the following clinically important variables: sleep, psychophysiology, cognition, social     function, and quality of life.   "
141598|NCT01431079|"     The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV)     vaccine acceptability among college men based on the Health Belief Model through focus     groups, (2) triangulate focus group results with a prior quantitative study in developing an     intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3)     test the efficacy of the above intervention based on the Health Belief Model by comparing it     to a knowledge-based intervention. Approximately five focus groups with ten participants in     each group with college students in the ages 18-25 years will be conducted at a large     Midwestern University for the qualitative piece. Data will be analyzed for categories and     triangulated with previous study to develop a theory based intervention. For the quantitative     piece a randomized controlled design with 45 participants in each arm (theory based     intervention and knowledge based intervention) will be implemented.   "
141601|NCT01431040|"     Preoperative bowel preparation for surgical management of pelvic floor disorders is performed     inconsistently, and includes no prep, the use of dietary changes or bowel altering     interventions. Retrospective studies of emergency colonic surgery first demonstrated a low     rate of infectious complications without a bowel prep. Recently, data supporting the routine     use of mechanical cleansing for elective colorectal surgery has demonstrated the surgical     outcomes are similar between patients that undergo a bowel preparation versus those that do     not, indicating that the long held dogma of mechanical bowel preparation should be used     selectively. Despite routine use, there is a paucity of literature addressing the approach     to, and/or need for preoperative bowel management at the time of vaginal reconstructive or     obliterative surgery. The majority of the pelvic floor disorder population is older, tending     to have more bowel dysfunction (especially symptoms of constipation) than younger women.      The aim of this study is to evaluate preoperative bowel management strategy as it relates to     the total care of the vaginal surgery patients' intra-and post-operative bowel function and     overall patient experience. Two commonly used pre-operative bowel prep strategies: no     preoperative bowel prep versus clear fluids and 2-enema prep. The aim is to assess the value     of bowel preparation or diet change in vaginal surgery, both from the physician's and     patient's point of view. In this pilot study, subjects are randomized to either a clear     liquid diet the day prior to surgery with 2 enemas and nothing by mouth (NPO) after midnight,     or NPO after midnight without any dietary changes or enemas.      Our aims are:      *Primary - To assess the surgeons' objective intraoperative evaluation of the effects of     bowel preparation (adequate visualization, stooling during case, difficulty with bowel     handling) *Secondary - (1)To characterize the patients' experience and acceptance of     preoperative bowel management regimen versus no preoperative bowel preparation(2) To     characterize the patients' postoperative experience and determine if the preoperative bowel     regimen affects time to first bowel movement/first normal stool as well as stool experience     as recorded by bowel diary (3)Evaluate the incidence of complications between the two groups     (4)Characterize other descriptive qualities of the patients' operative experience(duration of     case, length of hospital stay)   "
141602|NCT01431027|"     Diastolic dysfunction refers to abnormal mechanical properties of the myocardium and includes     abnormal LV diastolic distensibility, impaired filling and slow or delayed relaxation-     regardless of whether the ejection fraction is normal or depressed and whether the patient is     asymptomatic or symptomatic. Epidemiologic studies have demonstrated high prevalence of     diastolic heart failure (DHF). The quality of life of these patients is impaired and the     clinical outcomes are similar to those with heart failure with systolic dysfunction.     Therefore diastolic dysfunction has significant adverse economic impact that is expected to     grow further with time. Clinical characteristics alone may not be sufficient to diagnose     diastolic dysfunction. A number of invasive and non-invasive parameters have been proposed to     diagnose diastolic dysfunction. Most of the presently used non-invasive parameters have a     number of limitations. High fidelity measurement of the left ventricular pressures is needed     to accurately diagnose diastolic dysfunction. Obtaining it in routine clinical practice is     impractical.      In this protocol the investigators have proposed a novel non-invasive parameter called     'Torsional Hysteresis' as a measure of diastolic function. This will be measured using     non-invasive cardiac MRI technique. During left ventricular contraction and relaxation,     myocardium deforms. During cardiac cycle the myocardium goes back to baseline state prior to     beginning of each contraction. However the rate with which it returns to the baseline state     is variable. Torsion indicates relative wringing motion of the ventricle around a left     ventricular axis and is a global parameter of left ventricular deformation. The parameters     have defined a new parameter called torsional hysteresis based on non invasive cardiac MRI     assessment. The parameters have hypothesized that for diastolic dysfunction, the torsional     hysteresis area is increased as compared to no diastolic dysfunction group.   "
141603|NCT01431014|"     Postoperative swelling is one of most common concerns to plastic and oromaxillary surgeons     after orthognathic surgery. The purpose of this study is to develop a steroid regimen     protocol for minimizing postoperative facial swelling after orthognathic surgery.   "
141604|NCT01431001|"     The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive     transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.   "
141605|NCT01430988|"     The purpose of the current study is proposed to prospectively assess how accurately the     BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.   "
141606|NCT01430975|"     This study is to be performed at two clinical sites where patients received CardioGen-82     during the time period January to June, 2011 and where patients were scanned chronologically     near to the index patients (2 days before or after). Of these, it is planned that at least 30     patients will be entered in this trial. Index patient is the term applied to individuals who     had radiation spectra indicative of Sr-82 and Sr-85 detected by hand-held survey meters.   "
141607|NCT01430962|"     The purpose of the study is to determine if there are any differences in yield or safety of     Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of     bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation.   "
141608|NCT01430949|"     The Genesis Feasibility Study will collect clinical information on the use of the Bard     Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping,     cardiac stimulation and radiofrequency ablation in the region of the pulmonary vein (PV)     ostia for the treatment of patients with Paroxysmal Atrial Fibrillation. Patients will be     followed up for 12 months to assess the primary safety endpoint of Major Complications (a     composite safety endpoint)and effectiveness, defined as Long-Term Success (freedom from     recurrent atrial arrhythmia.   "
141609|NCT01430936|"     This is planned as a feasibility study. The objective is to evaluate a specially designed     patient adherence and monitoring software on standard mobile devices in remote monitoring of     heart failure patients.   "
141610|NCT01430923|"     The purpose of this study is to:        -  To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost          stored at refrigeration temperature with respect to the diurnal intraocular pressure          (IOP) change from baseline after 3 months of therapy in patients with open-angle          glaucoma (OAG) or ocular hypertension.        -  To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients          with open-angle glaucoma (OAG) or ocular hypertension.   "
141831|NCT01428024|"     The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip     products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the     injection technique.   "
141612|NCT01430897|"     Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in     d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the     assessment of the right ventricle (RV).      In this study the investigators sought to evaluate systemic RV myocardial mass and function     after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function     under special consideration of the interventricular septal (IVS) movement.   "
141621|NCT01430780|"     Basic studies has showed that sustained use of nitrates might associated with adverse effects     on vascular function mediated by an increase in nitrate-induced oxidative stress. But it     remains unclear whether oxidative stress increases with endothelial function impairment in     patients with coronary artery disease (CAD) during administration of long-term oral nitrates.     The investigators evaluated whether administration of long-term isosorbide mononitrate (ISMN)     treatment was associated with oxidative stress increase and endothelial function impairment     in patients with CAD.   "
142614|NCT01417780|"     A study to evaluate the safety and pharmacokinetics profile of different doses of AB103     administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled     for an urgent surgical intervention as part of their standard of care.   "
141613|NCT01430884|"     During elective percutaneous coronary intervention (PCI), both proximal and distal protection     devices are used. The distal occlusion protection device temporarily occludes the vessel     distal to the lesion during the intervention, thereby capturing both particular debris and     soluble substances released from the lesion such that they can be aspirated and prevented     from reaching the coronary microcirculation. Rather than simply discarding the material which     is retrieved from use of protection devices, the investigators have recently taken advantage     of this situation, sampled the particulate and soluble material and subjected it to a variety     of analyses with the ultimate goal to have a better insight into the respective plaque     composition and to correlate it to the individual imaging and clinical data. On the basis of     such information the investigators aim to better understand the pathophysiology of plaque     vulnerability and to possibly predict the clinical development of the individual patient.   "
141614|NCT01430871|"     Serotonin has recently been identified as a major regulator of bone formation. Gut-derived     serotonin inhibits bone formation, and early animal studies have shown that inhibition of     gut-derived serotonin has anabolic effects on bone in ovariectomised rodents. This pathway     has potential to be developed as a new anabolic treatment for osteoporosis in humans.      Carcinoid neuro-endocrine tumours produce very high levels of serotonin, and so it might be     expected that patients with carcinoid disease would have reduced bone formation, low bone     mass and fractures. However, this has not been apparent in clinical practice. There may be a     discrepancy between rodent models and human disease. This study aims to identify whether     patients with carcinoid disease have reduced bone mass, reduced bone formation or high     fracture rates. The investigators will conduct a cross-sectional observational case-control     study of patients with carcinoid disease in the Sheffield neuro-endocrine tumour clinic and     gender-, age- and body mass index (BMI)-matched controls.   "
141615|NCT01430858|"     The overall aim of this study is to test the hypothesis that vibration exercise can induce     higher than normal bone strains and strain rates than are experienced during habitual     locomotor activities.      The investigators plan to study healthy young volunteers to:        1. Determine the relationship between tibial bone strain and             -  the frequency and amplitude of vibration therapy             -  a range of habitual locomotor activities;        2. Determine the transmission of vibrations during vibration therapy, in terms of             -  amplitude attenuation and phase shift of positional coordinates and accelerations               at anatomic landmarks along the lower leg and other skeletal sites             -  the relationship between these and different frequencies and amplitudes of               vibration therapy;        3. Determine the muscle power in the lower limb associated with various habitual locomotor          activities and its relationship to the measured tibial bone strain.      The investigators subsequently hope to use the data captured in this experiment to develop a     QCT-based finite element (FE) model of the human lower limb (tibia, fibula and foot). The     investigators will then validate this model in relation to the characteristics (amplitude and     phase shift) of the measured tibial bone strain and transmission of vibrations to the     different anatomical landmarks during vibration therapy.   "
141616|NCT01430845|"     The purpose of this study is to find the relationship between the stage and quality of     developmental delay during infancy and toddler age, and the final diagnosis that the child     gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).   "
141617|NCT01430832|"     The purpose of this study is to assess the emotional well being of mothers to preterm infants     with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will     be taken into consideration. In addition, the correlation between the infant's development     and the mother's emotional state will be analyzed.   "
141618|NCT01430819|"     The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012     formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and     older.      Objectives:        -  To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥          65 years of age.        -  To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among          adults ≥ 65 years of age.   "
141619|NCT01430806|"     Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other     antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion     channel properties similar to amiodarone.      Several case reports have shown promising results with Dronedarone for this patient     population.   "
141620|NCT01430793|"     The purpose of the study is determination of effective vitamin D replacement strategy in     vitamin D deficiency states with currently available preparations in Pakistan & to determine     the cost effective monitoring strategy with urinary calcium excretion serving as a surrogate     marker of achievement of vitamin D sufficiency state.      The study will be conducted at the out-patient Endocrinology Clinics of the Aga Khan     University Hospital, Karachi, Pakistan. All patients seen in endocrine clinics with Vitamin D     level less than 20 ng and do not have any of exclusion criteria mentioned below will be     eligible for recruitment in the study. The study participants will be randomly assigned into     4 groups for intervention to receive intramuscular or oral Vitamin D in 200,000 or 600,000     units as per group allocation. Each group will comprise of 25 participants.      Group 1: Vitamin D3 600,000 units IM and then every 2 monthly for 2 times if levels remain <     30 ng/ml.      Group 2: Vitamin D3 600,000 units orally and then every 2 monthly for 2 times if levels     remain < 30 ng/ml.      Group 3: Vitamin D3 200,000 units IM initially and then every 2 monthly for 2 months if     levels remain < 30 ng/ml.      Group 4: Vitamin D3 200,000 units orally initially and then every 2 monthly for 2 times if     levels remain < 30 ng/ml.      All patients will be prescribed elemental Calcium 1 gram /day. Vitamin D levels along with     the other biochemical parameter and random urine for calcium & creatinine will be checked at     00, 02, 04, 06 and 12 months.   "
141832|NCT01428011|"     The purpose of this study is to understand how communication between African American and     white patients with high blood pressure and his/her primary care provider effects whether a     patient decides to take their high blood pressure medications.   "
141813|NCT01428258|"     For individuals with Phenylketonuria (PKU), the investigators hypothesize that     glycomacropeptide will provide an acceptable form of low-phenylalanine dietary protein that     will improve dietary compliance, blood phenylalanine levels, cognitive function, and     ultimately quality of life compared with the usual amino acid based diet. The study is funded     by the Food and Drug Administration (FDA) Office of Orphan Products Development Grants     Program, R01 FD003711.   "
141622|NCT01430767|"     Poor adherence is a common reason for treatment failure in many fields of medicine, and     likely affects common psychiatric treatments as well. Members of the present study team have     used Medication Event Monitoring System (MEMS®) caps effectively to objectively monitor     adherence in skin disease, and have shown that they provide a much more accurate measure of     adherence behavior than self-reports, pill counts, or serum drug concentrations. The present     study will use MEMS® caps to measure adherence in 10 patients with depression and 10 patients     with attention-deficit hyperactivity disorder (ADHD) from a student clinic population. The     aims will be to show the usefulness of MEMS® caps in measuring adherence to psychiatric     treatment, and gather data on typical adherence rates for depression and ADHD patients on     typical treatment regimens. The data obtained will be used to inform future studies that use     an intervention to improve adherence behavior and ultimately disease outcomes.   "
141623|NCT01430754|"     The purpose of this study is to evaluate the maintenance effect and safety of 20 mg     tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.   "
141624|NCT01430741|"     A major goal for the Department of Veterans Affairs is to end Veteran homelessness by 2015.     The VA's largest homelessness initiative is the joint Departments of Housing and Urban     Development (HUD) and Veterans Affairs (VA) Supportive Housing program (HUD-VASH), which has     been expanded greatly over recent years via the allocation of 30,000 Housing First vouchers     between 2008 and 2010 and increased funding to hire 1,000 new program case managers. However,     recent expansion has resulted in a number of implementation challenges including delays in     the distribution of housing vouchers and dropout among program participants (25% of those     housed in HUD-VASH drop out within a year). Much of this dropout can be attributed to     untreated issues facing many Veterans enrolled in HUD-VASH. The most common among these     untreated issues are mental health and substance use disorders. The presence of these     disorders is due in large part to the fact that much of HUD-VASH case management focuses on     housing placement and maintenance, with limited attention to mental health, substance abuse,     and other related psychosocial issues, which when left untreated, negatively impacts voucher     distribution and housing stability. This project will test an implementation model-Getting To     Outcomes (GTO)-designed to assist in the delivery of an intervention for Veterans with     co-occurring mental health and substance use disorders (MISSION-Vet) in the HUD-VASH program.     The proposed study will compare implementation of MISSION-Vet currently being planned through     VA Office of Patient Care Services to an enhanced approach using the GTO model. Thus, this     project can contribute to ending all Veteran homelessness by 2015, a pledge made by President     Obama.   "
141625|NCT01430728|"     The purpose of this study is to examine the range of cerebral tissue oxygen saturation in     healthy and sick very low birthweight infants during the first 72 hours of life.   "
141626|NCT01430715|"     The increasing use of sedentary screen-based activities (SBAs) has been most recently blamed     for children and adolescents' lack of engagement in physical activity (PA). Studies indicate     a large portion of children participate high-levels of sedentary SBAs and the sedentary SBAs     appear to compete for time to engage in PA. If sedentary behavior is a substitute for PA, to     help increase PA, strategies need to be put into place that helps to decrease sedentary     behaviors.      One modification to sedentary videogames that may increase PA in children is to alter     sedentary videogames so that the videogames actually provide an option to engage in PA,     rather than to be sedentary. These types of games then don't compete with PA, but actually     are a source of PA. These types of videogames are called active video games (AVG) or     Exer-gaming. Previous research demonstrates that energy-expenditure (EE) in AVG play is     comparable to moderate-intensity walking and produce greater EE than sedentary SBAs. However,     previous studies have been limited to measuring EE in AVG play to walking either on a     treadmill or in a structured setting. Studies have not investigated the EE of AVG play     compared to the EE in free-living outdoor play. Thus, the purpose of the proposed study is to     determine whether a greater EE is released during AVG play compared to free-living, outdoor     play in children.   "
141627|NCT01430702|"     Care transition interventions have been successful in reducing medication-related problems     and associated rehospitalization primarily by focusing on medication reconciliation conducted     by trained healthcare professionals. Programs to improve the medication reconciliation     process have largely been effective, but have limitations including the expense associated     with recruiting, training, and retaining care transition healthcare professionals (e.g.,     nurses and nurse practitioners) the ability to provide services within a finite geographic     area, and the retrospective nature of the reconciliation process which usually occurs in the     home following hospital discharge. Our short-term objective is to use Pennsylvania Department     of Aging resources to assess the feasibility of using a telemedicine medication delivery unit     for frail older adults that require medication assistance in their home immediately following     an acute hospitalization. As part of this feasibility assessment, the investigators will     assess (1) recruitment process and procedures, (2) data collection procedures, (3) resource     utilization, (4) drop-out rates, (5) acceptability and usability of the EMMA® telemedicine     medication delivery unit, (6) medication adherence, and (7) medication-reconciliation errors     during transition from hospital to home.   "
141667|NCT01430182|"     The purpose of this study is to determine whether, for surgery of the tibia, one dose of     methadone provides better control of pain afterward as compared to morphine, which is the     usual drug given to control pain after surgery. Immediately after the beginning of general     anesthesia (intraoperatively), subjects will receive one dose of either methadone or     morphine, in the amount of 0.2 milligrams per kilogram of body weight, intravenously.      The primary hypothesis is that, subjects who receive one dose of methadone intraoperatively     will require less pain medicine than subjects who receive one dose of morphine     intraoperatively.   "
141742|NCT01429194|"     The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using     endoscopic guidance to trans-orally place plications in the stomach in obese subjects to     reduce volume and expansion of the fundus and greater curve to abate hunger as part of a     supervised weight reduction program.      The primary objective of this study is to perform an evaluation of the safety of the     plication procedure.      The secondary objective of this study is to evaluate the preliminary efficacy of the ACE     Stapler for the treatment of obesity over a 24 month follow-up period.   "
141628|NCT01430689|"     The Center for Vaccine Development - Mali is interested in learning if vaccinating a pregnant     woman against influenza will protect her infant against this disease. The investigators know     that influenza infection, the flu, affects pregnant women and their infants in Mali. The     illness known as flu is caused by a germ (virus) that is passed easily among people. The flu     causes symptoms such as fever, cough, sore throat, runny nose, and body aches. Certain groups     of people, such as pregnant women and infants, are at risk for having severe disease when     they get the flu. Vaccination against influenza is not routinely available to pregnant women     in Mali although it is recommended.      Women who wish to participate will have 5 visits to the clinic and weekly visits to the home     to follow the health of the woman and her infant when it is born. The investigators will also     ask permission to make weekly visits to all children under 5 years of age to follow their     health as it relates to influenza infection.   "
141629|NCT01430676|"     The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters.     The aim of present study is to use large-scale data from DVHD to uncover risk factors for     readmission, reoperation (any indication), death and reoperation for recurrence after     incisional hernia repair.   "
141630|NCT01430663|"     Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with     hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL)     samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is     unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested     PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at     high risk of PA.   "
141631|NCT01430650|"     The aim of this trial is compare two different endometrial priming protocols        -  women that receive oral estrogens        -  women that receive transdermal estrogens   "
141632|NCT01430637|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study is studying genes in samples from younger patients with     desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.   "
141633|NCT01430624|"     The purpose of this study is to evaluate whether a brief intervention in video format, that     includes education about reactions to assault and modeling of adaptive coping strategies,     designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of     sexual assault at the time of receipt of post assault medical care is associated with better     post-assault outcomes as compared to a comparable length video that includes pleasant imagery     and relaxation instruction or standard care.   "
141634|NCT01430611|"     This study is part of the post-licensure commitment to evaluate the safety and immunogenicity     of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.      Primary Objective:      To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30     days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide     Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C)     Polysaccharide Vaccine.      Secondary Objective:        -  To describe the immunogenicity for serogroups A and C, 30 days after administration of          the study vaccines given as a single dose.        -  To describe the full reactogenicity profile after administration of the study vaccines          given as a single dose.   "
141635|NCT01430598|"     The investigators aim to establish whether completing a subacromial decompression before or     after repair of a complete rotator cuff tear has any clinical significance. Both the     arthroscopic decompression and rotator cuff repair will be completed during the same surgical     date. The investigators null hypothesis contends that full-thickness rotator cuff tear repair     performed before versus after subacromial decompression will not influence patient's     post-operative pain or functionality.   "
141636|NCT01430585|"     PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis     that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or     acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high     Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker     of cellular proliferation, could be used to select those patients who benefit from treatment     with a PI3K-pathway inhibitor.   "
141637|NCT01430572|"     The goal of this clinical research study is to find the highest tolerable dose of the     combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients     with advanced cancer. The safety of these drugs will also be studied.      Pazopanib is designed to block different receptors in the cancer cells that ultimately are     responsible for the growth of the tumor and its blood vessels.      Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also     involved in cancer growth.   "
141638|NCT01430559|"     This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index     (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will     also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis     in this population.   "
141639|NCT01430546|"     The purpose of this study is to quantify the burden of treatment in relapsed or refractory     multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.   "
141640|NCT01430533|"     The purpose of this study is to determine the dermal sensitization potential of azelaic acid     pre-foam formulation.   "
141641|NCT01430520|"     Pain is a major problem after TKA, especially in patients with high pain catastrophizing.     Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and     emotional effect. The investigators therefore investigate the effect of Escitalopram as a     perioperative analgesic.   "
141698|NCT01429766|"     100 suitable patients of lung cancer shall be taken into the study over a period of 2 years.     As per the existing treatment protocol in our department, all patients suitable shall undergo     a routine Pulmonary function testing (PFT). Subsequently, recording of the breath hold shall     be done at the following times        1. At time of simulation        2. At the time of first fraction of radiotherapy        3. At mid radiotherapy        4. At radiotherapy conclusion After the recording at a), patients shall be asked to perform          deep breathing exercises/spirometer ball exercise to see the effect of training on the          breath holding times.   "
141642|NCT01430507|"     Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that     causes progressive damage to joints of the body, affecting the functional capacity. Effective     management of patients with RA requires a multidisciplinary approach. Despite the various     combinations, there is a significant population of RA patients who are not responding to     these combinations or showing inadequate response to methotrexate alone. Hence, there is a     need for a unique combination of drugs targeting different pathological process to yield the     best results in those patients where prognosis is poor. Combination of revamilast with first     line therapy like methotrexate could provide better treatment options to a larger population     of RA patients having moderate to severe disease and who are inadequately controlled on one     or the other DMARDs.      This is randomized, double-blind, placebo-controlled, parallel group study. The study will     include patients with active RA receiving stable and maximum tolerated dose of MTX.      Patients will be recruited after providing written informed consent. After screening and run     in period (single blind placebo for 4 weeks), patients will be randomized (meeting     randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium     and High) of revamilast or placebo along with MTX.      The primary objective of the study is to determine the percentage of patients achieving ACR20     response at 12 weeks. Secondary objectives include determining percentage of patients with     ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values and     frequency and use of rescue medication.      During the treatment period, there will be 5 further study visits at week 2, week 4, week 8,     week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be follow     up visit.   "
141643|NCT01430494|"     To collect characteristics of patients with ADPKD across a broad population, over time to     better understand disease progression (signs, symptoms and outcomes). Association with total     kidney volume changes and other measures of disease progression will be determined in order     to identify a population at increased risk for disease progression. The economic and quality     life impact of ADPKD will be assessed. Subjects who terminated participation early from     clinical trials with tolvaptan may also be followed.   "
141644|NCT01430481|"     The aim of this study is to compare three combinations of preparations in a comparative trial     program on rosehip powder for knee OA. The trial is a comparative, 12-week, randomized,     double-blind, active-controlled trial, designed to determine the comparative efficacy and     safety of these preparations in patients with pain from knee OA.   "
141645|NCT01430468|"     This is a non blinded prospective randomized clinical trial to define the efficacy of a new     technology developed at the Cleveland Clinic to improve the positioning of the glenoid     component in total shoulder arthroplasty. The Cleveland Clinic research team has worked on     the development and validation of this new technology for the last six years. The     investigators have validated the pre-operative planning software and published the results in     the peer review literature (1, 7, 8, 9). The investigators have used this software in the     planning of total shoulder surgery over the last three years. The investigators have     validated the accuracy and reproducibility of the patient-specific instrumentation in both     cadaver shoulders and Sawbones models of the shoulder using multiple surgeons. These studies     also validated our ability to precisely measure component position using 3D CT scan imaging     after placement of the implants in a pre-clinical cadaver study, thereby validating our     ability to accurately measure and compare component position between the groups described in     this proposed clinical trial. The investigators have also proven the ability of the software     and techniques to produce an accurate representation of the glenoid morphology in patients     with osteoarthritis or rotator cuff deficient arthritis in 13 patients. This was an IRB     approved patient safety study performed at the Cleveland Clinic. The investigators have     performed extensive studies of the materials and processes for the fabrication, sterilization     and packaging of the patient specific instruments. The investigators have selected materials     and processes that have met all of the FDA requirements for use of these materials and     processes as clinical devices in vivo. These devices (non implanted instruments) are     generally classified by FDA as a Class I device not having significant clinical risk. The     investigators have studied the materials and process to produce accurate instruments that     meet the clinical specification for fit onto the surrogate glenoid surfaces and maintain this     shape and fit after sterilization. These same patient specific instruments have been tested     in pre-clinical trials (Sawbones and Cadavers), demonstrating their ability to perform the     functions specified with a high level of accuracy and much better than the use of standard     generic instruments.   "
141646|NCT01430455|"     This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective     treatment of bipolar depression. New treatments are needed, as there is little evidence that     standard antidepressants are effective in treating this condition, and the two antipsychotic     medications that have indications for bipolar depression can cause substantial side effects.     This study will focus specifically on currently depressed outpatients having a bipolar     history for whom at least one standard antidepressant medication was ineffective. Patients     will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.   "
141647|NCT01430442|"     The purpose of this study is the exploration of a wide range of BMS-927711 doses that will     reveal at least one dose that is safe and clinically superior to placebo in the treatment of     acute migraine.   "
141648|NCT01430429|"     The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in     primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.   "
141649|NCT01430416|"     This study has two parts, dose escalation and dose expansion. For dose escalation, the     primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with     uveal melanoma. For dose expansion, the primary objective is to characterize the safety and     tolerability of the MTD of AEB071 in patients with uveal melanoma.   "
141650|NCT01430403|"     The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments ―     omalizumab, corticosteroid therapy boost, and placebo ― in reducing fall exacerbations in     inner-city children and adolescents with allergic persistent asthma when initiated     approximately 4 -6 weeks prior to the start of the first day of each participant's school     year.   "
141651|NCT01430390|"     The purpose of this study is to test the safety of giving the patient special cells from a     donor called Modified T-cells. The goal is to find a safe dose of modified T-cells for     patients with relapsed B cell leukemia or lymphoma after a blood SCT. The investigators also     want to find out what effects these T-cells have on the patient and the disease.   "
141652|NCT01430377|"     The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous     coronary intervention (PCI) is still not established. The predilatation could potentially     damage SB ostium by vessel dissection, making subsequent wiring problematic. However,     predilatation could eliminate SB ostial stenosis obviating need for further SB treatment     after main vessel stent implantation. The aim of the study is to assess in random fashion the     periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and     without SB predilatation.   "
141653|NCT01430364|"     Study aims: to compare two intervention strategies for bifurcation treatment - provisional     T-stenting (PTS) with drug-eluting stent (sirolimus eluting), with kissing balloon inflation     at the end of procedure - the best treatment strategy at the moment, with stenting of     bifurcation lesions with dedicated bifurcation drug-eluting stent BiOSS Lym.   "
141711|NCT01429597|"     Primary objective and endpoint is the analysis of the long-term course of lyso-Gb3 and its     clinical correlation to the progression of the cardiomyopathy in N215S-Fabry patients.   "
142077|NCT01424787|"     The objective of this non-interventional study is to confirm that with standard OsvaRen®     treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus,     total calcium, and iPTH seen in the CALMAG study also in the normal clinical practice.   "
141654|NCT01430351|"     The goal of this clinical research study is to find the highest tolerable dose of     temozolomide in combination with memantine, mefloquine, and/or metformin that can be given to     patients with glioblastoma who have already been given radiation and chemotherapy in     combination. The safety of these drug combinations will also be studied.      Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of     cells). The damaged DNA may cause tumor cell death.      Memantine is designed to block the activity of a protein found on the surface of cells that     may control tumor growth and survival. This may stop further spread of tumor cells.      Mefloquine is designed to block a protein that helps to clean the waste in the cells and to     destabilize the cell membrane. Blocking this protein may cause tumor cell death.      Metformin is designed to block a protein in tumor cells that is important in tumor growth and     blood vessel development. This may cause cell death or reduce the spread of the disease.   "
141655|NCT01430338|"     Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and     especially during acute cold exposure. It is conceivable that BAT activity might reduce the     risk of developing obesity since fat stores are used for thermogenesis, and a directed     enhancement of adipocyte metabolism might have value in weight reduction. So it is important     to know the different metabolic characteristics in human adults who have detected BAT.     Therefore, the purpose of the investigators study is to compare different metabolic     characteristics in the presence of brown adipose tissue in humans.   "
141656|NCT01430325|"     SCUBA divers and chamber inside attendants will undergo a brief hyperbaric chamber excursion     and will be asked to what chamber pressure they were compressed and what gas they breathed.   "
141657|NCT01430312|"     The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam     formulation.   "
141658|NCT01430299|"     The objective of this study is to prospectively evaluate the performance of Integra Accell     Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a     retrospective comparison to a historical patient cohort.   "
141659|NCT01430286|"     The aim of the project is to evaluate the efficacy of a web-based psycho-educational     programme designed to support informal caregivers of patients with Alzheimer's disease     (AD).This program focuses on information about the illness, her progression, how to prevent     psychological strain using anticipation and relaxation techniques and providing a virtual     space (forum) to discuss with other caregivers.   "
141660|NCT01430273|"     Main Objective: The purpose of this study is to demonstrate whether there is a correlation     between perioperative blood loss and the degree of platelet inhibition assessed by a point of     care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet     mono/bi-therapy   "
141661|NCT01430260|"     This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in     combination.   "
141662|NCT01430247|"     INTRODUCTION. Amblyopia is defined as the loss of visual acuity (VA) in one or both eyes,     without any obvious structural or pathological anomalies. Amblyopic eye should be able to     regain some VA if treatment is initiated before the age of seven. It is the leading cause of     monocular blindness in the 20- to 70-year olds with prevalence 2-5%. Amblyopia is mainly     monocular, hence children are general asymptomatic. VA testing is the only reliable method of     detecting amblyopia, and the fourth year of life is considered best for vision screening     programs.      AIM: The purpose of the study is to reduce the preventable vision loss. The main goal of the     study is to evidence the problem of amblyopia in Zagreb and to release a model for formal,     government directed vision-screening program as a Croatian public health policy.      HYPOTHESIS. In Croatia, the prevalence and actual effect of amblyopia and amblyogenic     factors, along with treatment efficacy is impossible to quantify, since no population-based     studies have been performed regarding this issue. In addition, national screening of     preschool children does not exist, while the school-entry screening is prescribed by law. The     object of the study is to determine the prevalence of amblyopia in a 4-4.5 year old children     of The Town of Zagreb, the efficacy of screening and effectiveness of treatment on reducing     amblyopia prevalence. The primary hypothesis is defined: screening of visual acuity     monocularly at distance and near in 4-4.5 year old children in Zagreb is effective in     detecting amblyopia.      PATIENTS AND METHODS: Monocular vision of about 7000 children/ year aged 4-4.5 for whom both     parents gave consent is to be tested with Lea chart at near (40cm) and distance (3m) in the     kindergartens of The Town of Zagreb. The criterion for referral to complete ophthalmological     examination is VA <0.8.   "
141663|NCT01430234|"     Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according     to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the     treatment to be effective. In addition, consultation of a specialized dietician is pivotal to     educate patients about the proper use of pancreatic enzymes. However, based on a recent     prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that     enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess     if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after     extensive patient-education in comparison to the standard treatment for patients with EPI.   "
141664|NCT01430221|"     The purpose of this study is to compare the effectiveness of educational and lifestyle     intervention programs aimed at reducing fasting blood sugar and emotional distress in adults     with prediabetes.   "
141665|NCT01430208|"     Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine     diseases. The development of smaller hysteroscopes allowed to change the approach to the     intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al.     developed a mini-resectoscope feasible for see&treat hysteroscopy. The objective of the     study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr     resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions.     The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas,     randomly allocated to receive the treatment with traditional resectoscope (127 women), with     mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating     time, distension media delivered, dismiss time and discomfort experienced were recorded.   "
141666|NCT01430195|"     The purpose of this study is to look at the efficacy of afamelanotide, when combined with     narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo.     Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to     reducing frequency and doses of NB-UVB.   "
141712|NCT01429584|"     Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the     neck, in the interscalene area, provide pain relief after shoulder surgery but can cause     temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower     concentration of bupivacaine would cause less weakness of the diaphragm but still provide     good pain relief. Lung function and pain control was studied after interscalene peripheral     nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.   "
141668|NCT01430169|"     This study is a Phase 2, open-label study to assess the pharmacokinetics (PK) and safety of     AA4500 0.58 mg in men with Peyronie's disease. Subjects will be screened for study     eligibility within 21 days before the initial injection of study drug. Two injections will be     administered 24 hours apart.      Subjects will be admitted to the study unit the day before the first injection of AA4500 (Day     -1) and will remain in the study unit until after the PK sample is collected after     investigator penile plaque modeling on Day 3. Subjects will return to the study unit on Day     4, Day 8, and Day 29 for follow-up pharmacokinetic and safety assessments.Pharmacokinetic     plasma samples will be collected at predetermined time points before (15 minutes     pre-injection) and after each injection on Day 1 and Day 2 (5,10, 20, 30 minutes and     1,2,3,4,8,12 hours after), and on Days 3, 4, 8, and 29.Plasma levels for AUX-I (clostridial     type I collagenase) and AUX-II (clostridial type II collagenase) will be determined.   "
141669|NCT01430156|"     This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of     Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can     upregulate HO-1, which has been shown to have a protective effect on animal transplants.      The investigators will be giving HA/placebo to participants prior to transplant and repeat     again on day 2 post-transplant and compare outcomes.   "
141670|NCT01430143|"     The aim of the study is to 1) delineate the molecular mechanisms behind the large variation     in insulin sensitivity among apparently healthy subjects and to 2) establish the     dose-response relationship between physical training and a) metabolic health, b) appetite and     c) cultural health.   "
141671|NCT01430130|"     Neodyne has developed an investigational dressing for post-operative incision care. Neodyne     is conducting this research to study whether the investigational dressing, called the Neodyne     Dressing, can minimize scar formation in a simple manner.   "
141672|NCT01430117|"     The objective of this study is to determine the biologic activity of a Poa pratensis allergen     extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference     preparation (IHRP).   "
141673|NCT01430104|"     The purpose of this trial is to assess the effects on serum calcium when teriparatide is used     with active vitamin D in osteoporosis patients.      This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment     Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium     supplementation from the Lead-in Period throughout the study. During the Treatment Period,     daily administration of teriparatide will be added.   "
141674|NCT01430091|"     This study compares the clinical tablet formulation of prasugrel taken orally with an orally     disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel     active metabolite circulating in the blood for each treatment.   "
141675|NCT01430078|"     The objective of the study is to assess the bioavailability of ASP015K within the     gastrointestinal tract.   "
141676|NCT01430065|"     This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy     volunteers.   "
141677|NCT01430052|"     The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1     combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable     locally advanced pancreatic cancer.   "
141678|NCT01430039|"     Syndecan-1 is a protein on the surface intestinal cells. previous studies proved low levels     of mucosal syndecan-1 levels on the surface of intestinal cells is patients with acute and     chronic inflammation due to inflammatory bowel disease.      this protein might shed from cell surface to the serum. The investigators wish to prove that     elevated serum levels of syndecan-1 may be predictive of disease presence, extent and     severity, that buy taking a simple blood sample from patients diagnosed with inflammatory     bowel disease and comparing to normal subjects and to other markers.   "
141679|NCT01430026|"     The propose of this study to determine efficacy and complication of gentamicin nasal     irrigation in chronic rhinosinusitis   "
141680|NCT01430013|"     To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T     cell lymphoma.   "
141681|NCT01430000|"     Patients who completed the conventional treatment against HCV and relapsed (the virus     appeared again in their blood) have no effective therapy.   "
141682|NCT01429987|"     This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose     ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to     placebo in patients with Chronic Idiopathic Constipation (CIC).   "
141683|NCT01429974|"     Meconium constitutes the bowel contents of the fetus and is normally expelled only after     birth. However, it may be secreted into the amniotic fluid of 20% of all fetuses. Meconium     Stained Amniotic Fluid had been recognized from ancient times as an obstetric hazard which     complicates delivery and is associated with increased newborn morbidity and mortality. At     present there is no viable diagnostic test for Meconium prior to the onset of labor and the     rupture of membranes. The system developed for the detection of Meconium, based on     recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light     excitation at a specific wavelength. The diagnostic test being developed does not require     penetration into the amniotic sac and is safe, painless and simple to perform.   "
141684|NCT01429961|"     Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with     Advanced Hepatocellular Carcinoma   "
141685|NCT01429948|"     We hypothesized that paradoxical embolism may be one of the main mechanisms of silent     cerebral infarction (SCI) located outside the perforating artery territory. In the present     study, we evaluated the association between SCI and paradoxical embolism detected by agitated     saline transcranial Doppler (TCD) monitoring in healthy subjects without history of stroke or     transient ischemic attack (TIA). We also compared the frequency and amount of paradoxical     embolism between healthy subjects with SCI and acute stroke patients with presumed     cryptogenic embolism or conventional stroke mechanisms.   "
141713|NCT01429571|"     Three patient groups with simple hand infections are tested regarding the necessity of     antibiotics after surgical treatment.   "
141833|NCT01427998|"     Background: Animal studies indicate that olive leaf extract normalizes blood glucose. We     hypothesized that olive leaf extract might be of benefit in human subjects.      Methods: A total of 79 adults with diabetes were randomly assigned to treatment with olive     leaf extract capsules or matched placebo. Measures of glucose homeostasis including glucose,     insulin and HbA1c were measured and compared by treatment group.   "
141686|NCT01429935|"     Ginger contains constituents with pharmacological properties similar to the novel class of     dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the     cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer     side effects than conventional NSAIDs and now are being investigated as a novel class of     anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory     components, its efficacy on acute inflammation was not assessed before. The common     postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling,     related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a     crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental     pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy     of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several     clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal     ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an     effective, oral analgesic with a more favorable safety profile. The primary aim of this study     was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce postoperative     swelling, pain and trismus in an acute pain model.   "
141687|NCT01429909|"     Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing     neuronal activations during motor or cognitive tasks. The MRI sequences used are currently     optimized for the study of cortex activations, particularly concerning the echo time     (TE).Very few studies are interested in optimizing the fMRI for the study of the basal     ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The     T2 * is a tissue parameter dependent of iron content, which differs with brain structures and     probably also with age and in case of neurodegenerative disease. Optimal TE s should     correspond to the T2 * of studied brain structure The primary purpose is to optimize the fMRI     by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The     secondary purpose is to study the effect of age and Parkinson's disease on T2*.   "
141688|NCT01429896|"     Food allergy is a common problem, affecting 5-8% of the population. Peanut allergy causes     reduced quality of life due to the perceived high risk of severe reactions. Patients rely on     accurate labeling of both loose and pre-packed foods, but these are often ambiguous and     unhelpful. There is a common conception that labeling is 'over-cautious'. Peanut-allergic     consumers face increasingly restricted food choices in complying with this advice due, in     part, to the proliferation of advisory labels such as 'may contain peanuts'. This contributes     to the reduces quality of life of affected individuals.      For industry to provide more accurate and helpful labeling, certain characteristics of the     food-allergic population need to be defined. Firstly, the minimum 'eliciting dose' for the     population has been estimated by studying large groups of peanut allergic patients who are     challenged with peanut ingestion in increasing amounts. From these, an eliciting dose that     provokes a reaction in 10% of the food-allergic population has been estimated at between six     and 14mg of peanut protein.      Translation of population eliciting doses (ED) into acceptable levels of allergen     contamination for the population requires consideration of a 'safety factor'- to account for     individual variability in dose threshold and severity. Data suggest such variability depends     in part on extrinsic factors (exercise and sleep restriction). Each factor may have a     different effect in scale and direction. The investigators are proposing a cross-over trial     with 85 peanut-allergic adults who will each undergoing a baseline peanut challenge followed     by repeat challenges with extrinsic factors applied, in random order (repeat baseline,     +exercise and +sleep restriction). These data will further define ED for the UK population     and a safety factor derived from shift in threshold, to inform industry and protect the     allergic population.   "
141689|NCT01429883|"     Patients with Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea     or Epikondylopathia humeri /radii get the shock wave therapy in our clinic as planned. During     our study the investigators want to ask for pain, pain reduction and function.   "
141690|NCT01429870|"     Objective(s):      (i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb     and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50%     loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent     treatment.      (ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb     and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).        -  Trial with medicinal product   "
141691|NCT01429857|"     The purpose of this study is to investigate the prognostic value of admission     high-sensitivity troponin in patients with acute decompensated heart failure.   "
141692|NCT01429844|"     The purpose of the study is to compare efficacy and safety of two different immunosuppressive     regimens for prevention of bronchiolitis obliterans syndrome (BOS) (chronic lung allograft     rejection)after lung transplantation: tacrolimus versus cyclosporine, both in combination     with mycophenolate mofetil and steroids. The study was powered to detect a 15% reduction in     BOS in tacrolimus treated patients.      Study design: open-label, randomized, comparative, multi-center, investigator driven   "
141693|NCT01429831|"     The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in     outpatients with major depressive disorder who have had inadequate response to     antidepressants in Taiwan clinical practice.   "
141694|NCT01429818|"     The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin     over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM)     using 13N-ammonia-positron emission tomography (PET).   "
141695|NCT01429805|"     The purpose of this study is to obtain information on the safety and performance of HipJack     Balloon Spacer to access the central compartment of the hip and maintain intra-articular hip     joint distraction during arthroscopy of the central compartment of the hip.   "
141696|NCT01429792|"     This multi-center study will evaluate the viral response in patients with chronic hepatitis     C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a)     and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral     Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as     slow responders/non-rapid virological responders will be eligible for an additional 24 weeks     of treatment.   "
141697|NCT01429779|"     The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal     passage through the preoperative use of Movicol.      Hypothesis The use of Movicol® during one week prior to partial liver resection combined with     the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by     promoting early return of gastro-intestinal function, defined as the passage of stools and     early oral intake.   "
141740|NCT01429220|"     The purpose of this study is to evaluate the utility of a portable motion sensor-based system     designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's     disease patients.   "
141699|NCT01429753|"     Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in     patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to     improve LV function in patients with heart failure if those regions of the myocardium which     are most compromised by electromechanical dyssynchrony can be identified and effectively     stimulated. There still remains, however, a significant rate of up to 30% of patients who do     not respond to treatment. Reasons for lack of benefit can be related to the inability of     identifying and effectively stimulating those regions of myocardium, which are most     compromised by electromechanical dyssynchrony. The investigators hypothesize that by using     cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine     the site of latest LV activation, the investigators can find the best place to implant the     left ventricular lead. By avoiding scar and pacing in the site of latest activation, the     investigators believe the investigators will reduce dyssynchrony and thus improve overall     heart function. The researchers thus aim to increase the proportion of people who respond to     treatment. The researchers also believe that the procedure may be streamlined so as to reduce     procedure duration, radiation dose and dose of iodinated contrast medium.   "
141700|NCT01429740|"     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of     14 days of treatment with PF-05180999 in healthy subjects.   "
141701|NCT01429727|"     The primary goal of this project is to describe the clinical and physiologic characteristics     of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness,     understanding, treatment and prevention of a potentially fatal cardiovascular event.      This study will be a retrospective and prospective review of medical course and current     health of men and women with SCAD.      A prospective sub-study of echocardiographic findings after SCAD that includes perfusion     imaging (Lumason contrast) is available to patients who are evaluated at Mayo Clinic,     Rochester, MN. A separate consent process is included as part of this sub-study.   "
141702|NCT01429714|"     In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis     (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic     syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years.     It is however unclear whether all patients benefit to the same extent from this therapy or     what the optimal duration of ECS therapy for individual patients should be. ECS therapy is     not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial     costs could be saved by tailoring therapy to individual needs and as a result the quality of     life for individual patients can be expected to improve.      This study aims to assess the costs and effects of tailoring the duration of ECS therapy     after DVT to individual patients needs.      ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy,     following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The     primary outcome is the percentage of patients with PTS at two year follow-up.      This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.   "
141703|NCT01429701|"     Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity     and impaired quality of life due specially pruritus and physical visible skin lesions. The     purpose of this trial is evaluate the effectiveness of two different topic associations of     drugs.   "
141704|NCT01429688|"     The purpose of this study is compare the safety and pharmacokinetic characteristics of     DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after     multiple oral administration in healthy male volunteers.   "
141705|NCT01429675|"     The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg     Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd)     after oral administration in healthy adult volunteers.   "
141706|NCT01429662|"     The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR)     technique over no MR for treating hypertension in Thai postmenopausal women.   "
141707|NCT01429649|"     With the advent of CT screening for lung cancer, there is an increase in the detection of     pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass     opacities can be caused by normal expiration, partial filling of air spaces, partial collapse     of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic     proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still     largely unclear. A number of differential diagnoses are possible, including inflammatory     disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some     of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already     known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided.     The major issue is whether or not the doctors should treat these patients at all or wait     until the first sign of a solid lesion developes which may take many years.      The purpose of this study is to determine if the ablation therapy is safe and effective for     the pulmonary pGGO.   "
141708|NCT01429636|"     The purpose of this study is to demonstrate better efficacy and effectiveness of modified     applied relaxation technique over its original version for treating menopausal symptoms.   "
141709|NCT01429623|"     The purpose of this study is to determine whether treatment with the investigational drug     ladostigil will delay the onset of Alzheimer's disease(AD) in patients with Mild Cognitive     Impairment (MCI). MCI is now recognized as a precursor to AD and clinical tools are available     to assess cognitive performance at this earlier stage. Ladostigil is currently under     investigation for the treatment of AD. In this study, the investigators will be examining     ladostigil at a lower dose level. At this dose level, ladostigil has been shown to reduce     signs of early memory loss in animals. Thus, in this study the investigators are attempting     to determine if earlier invention with a lower dose of ladostigil will significantly reduce     initial memory loss and delay the subsequent progression to more serious cognitive     dysfunction.   "
141710|NCT01429610|"     The investigators would like to propose a phase-2 prospective multicenter trial evaluating     the efficacy of rituximab combination with our current chemotherapy strategy for adult Acute     Lymphoblastic Leukemia (ALL), in order to prove out whether the addition of rituximab during     induction, consolidation, and post-alloHCT status can improve the outcome in terms of     relapse-free survival (RFS) when compared with our prior data as a historical control.   "
141714|NCT01429558|"     The purpose of this project is to study live recordings from neuronal population of the human     nucleus accumbens during the implantation of deep brain stimulation (DBS) electrodes for the     treatment-resistant obsessive compulsive disorder (OCD). The central aim of this project is     to determine if intra-operative electrophysiological data can confirm that the electrode is     located in the nucleus accumbens. This confirmation could allow the placement of the DBS     electrodes with a higher degree of precision. An additional aim of this project will be to     study the activity of the neuronal population of the nucleus accumbens while a subject is     presented with a task involving an unexpected reward.      The investigators central hypothesis is that unexpected reward will be associated with     increase firing and synchrony in the neuronal population. This will translate into recordable     increase activity in the investigators region of interest and therefore confirm the proper     placement of the electrode.      This study enrolled 2 subjects, with 1 subject completing the protocol showing the     feasibility of the experiment. There were electrophysiological variations with the task     presented but no conclusion could be drawn given the small sample size.   "
141715|NCT01429545|"     The purpose of this study is to compare the tocolytic efficacy, effectiveness and safety of     Atosiban in comparison with the combination of Atosiban and Nifedipine together.   "
141716|NCT01429532|"     The purpose of this study is to compare the outcomes of cataract surgery performed with three     incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).   "
141717|NCT01429519|"     The study objectives are to evaluate safety and efficacy of topical administration of RPh201     oil solution (botanical extract) for treatment of patients with hard to heal chronic     ulcerated wounds.   "
141718|NCT01429506|"     In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy     with intensive medical management on weight and metabolic parameters.   "
141719|NCT01429493|"     In various common cancers, the skeleton is a preferred site of metastasis. These bone     metastases are the most common cause of cancer-related pain, which significantly impair     quality of life. It is postulated that the clinical target volume (CTV) of painful bone     metastases consists of cancer cells and tumor-associated host cells: the tumor-host     ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us     to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone     metastasis. These findings suggest the potential of intentionally non-homogenous dose     escalation (dose painting by numbers) to improve pain control. The hypothesis is that     fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone     metastasis regions confined with tumor-associated host-cell compartments responsible for     metastasis-related pain. The primary objective is to improve pain control with biological     image-guided stereotactic body radiotherapy compared to conventional radiotherapy.   "
141720|NCT01429480|"     TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method     after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest     methods of analgesia. The researchers wish to investigate whether the TAP block is as     effective as the ilioinguinal/iliohypogastric nerve block?   "
141721|NCT01429467|"     The aim of the study is to see how glycaemic control and glycaemic variability affect levels     of HIF, VEGF, erythropoietin and cortisol in Paediatric Type 1 diabetics on insulin pump     therapy.   "
141722|NCT01429454|"     The overall goal of the present study is to determine whether Omega-3 Fatty Acids potentially     prevent onset of psychosis and improve clinical symptoms and functional outcome in youth and     young adults at elevated clinical risk for schizophrenia and related disorders. The specific     aims are: (1) To determine whether the rate of progression to psychosis is lower during six     months of treatment with Omega-3 Fatty Acids compared to six months of treatment with     placebo, (2) To determine whether Omega-3 Fatty Acids are more efficacious than placebo for     prodromal symptoms, negative symptoms, and functioning, (3) To assess the safety and     tolerability of Omega-3 Fatty Acids in this population, and (4) To conduct analyses of     neuroimaging, neurocognitive, electrophysiological and other ancillary data to explore     mechanistic explanations for the hypothesized benefits of Omega-3 Fatty Acids on clinical and     functional outcomes (e.g., increases in white matter integrity and processing speed).   "
141723|NCT01429441|"     The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion     / (VMT) including macular hole with ocriplasmin.   "
141724|NCT01429428|"     This is a randomized and controlled study to investigate if the far-IR radiation emitted by     compression stockings fabric may be effective and safe as adjuvant treatment for cellulitis     that affects the majority of women after puberty.      The investigators expect that the far-IR effects on superficial microcirculation,deep dermis     and subcutaneous fat may attenuate the clinical aspect of cellulitis.   "
141725|NCT01429415|"     Acute asthma is the most common cause of pediatric hospitalizations. While the investigators     know that repeat inhalations of ß2 agonists and ipratropium with early oral steroids     substantially reduce hospitalizations, many children are resistant to this standard initial     therapy. About a third of children remaining in moderate to severe distress after standard     therapy are admitted to hospital and comprise 84% of pediatric acute asthma hospitalizations.     Finding safe, non-invasive, and effective strategies to treat children resistant to standard     therapy would substantially decrease hospitalizations resulting in considerable health care     savings and reduction of the psycho-social burden of the disease. While studies of magnesium     sulfate (Mg) given intravenously (IV) suggest that this agent can reduce hospitalizations in     both adults and children resistant to standard initial therapy Nebulization is an alternate     route for administering Mg. This route has the advantage of being non-invasive and is likely     much safer due to lower systemic delivery. Direct delivery via nebulization allows higher Mg     concentrations at the target site, the lower airways, with a smaller total drug dose. The     investigators propose to conduct a properly designed study to clarify the role of nebulized     Mg.   "
141741|NCT01429207|"     The purpose of the study is to test whether body-worn wireless motion sensors can measure     dyskinesias (involuntary movements caused by medications) in individuals with Parkinson     disease (PD) independent of voluntary activity being performed and other PD motor symptoms     (e.g. tremor).   "
142848|NCT01414712|"     The purpose of this study is to determine if a non-invasive cancer treatment, high-dose     stereotactic body radiotherapy (SBRT), is associated with changes in circulating tumor cells     counts in patients with low- and intermediate-risk prostate cancer.   "
141726|NCT01429402|"     Botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif) is widely used for facial     rejuvenation and many other medical indications. It induces chemodenervation through its     action on the presynaptic neuron, preventing release of acetylcholine, which leads to     functional denervation of striated muscle for 2 to 6 months after injection. The use of     botulinum toxin injection to reduce the facial scar is logical because this could reduce the     tensile distracting force of the upper lip caused by the orbicularis oris muscle pull.     Tollefson has demonstrate that botulinum toxin injection has decrease lip tension after     primary lip repair in 3 children at 3-6 months of age The main aim of this randomized trial     is to compare whether post-operative peri-surgical-injection of botulinum toxin into     bilateral orbicularis oris muscles can improve scar formation for both primary and secondary     cleft lip surgery.   "
141727|NCT01429389|"     The specimen collection is designed for the purpose of the development of a noninvasive     prenatal test for T21.   "
141728|NCT01429376|"     The aim of the present study is:        1. To investigate pulmonary function abnormalities (restriction, obstruction, diffusion          impairment, mixed pulmonary defects) in patients with chronic heart failure (CHF) and to          determine which of these pulmonary abnormalities prevail and to what extent.        2. To determine the prevalence, underdiagnosis, and overdiagnosis of chronic obstructive          pulmonary disease (COPD) as determined by spirometry and according to Global Initiative          for Chronic Obstructive Lung Disease (GOLD) criteria in patients with CHF.        3. To investigate the presence of systemic inflammation, as measured by inflammatory          parameters (leukocytes, platelets, high sensitivity CRP), in CHF patients with or          without COPD.   "
141729|NCT01429363|"     The prospective Clinical Series (CS) aims to prove the hypothesis that Targeted Disc     Decompression (TDD) reduces the pain in patients suffering from radicular leg pain secondary     to a contained focal disc protrusion (Lumboradicular Syndrome). Secondary objective will be     to prove that the treatment Group will have less disability and better quality of life.   "
141730|NCT01429350|"     The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as     an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator     (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV     rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not     work very well in cases where the stroke is caused by a large vessel occlusion. The     hypothesis being tested is to determine if the addition of a treatment by a mechanical     thrombectomy device like the Penumbra System can improve the clinical outcome of the patient     over just using IV rtPA alone.   "
141731|NCT01429337|"     The purpose of this international study is to assess the effect of varying degrees of     impaired hepatic function compared to a normal hepatic function (Child-Pugh classification)     on the pharmacokinetics and safety of midostaurin.   "
141732|NCT01429324|"     This study is designed to assess the feasibility of evaluating cerebral saturation during     critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral     Perfusion.   "
141733|NCT01429311|"     Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin     infections. A small subset of patients with AD suffer from disseminated viral infections,     e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum     (EV) after smallpox vaccination. Interferon gamma (IFNγ) plays a critical role in the innate     and acquired immune responses by activating macrophages, enhancing natural killer cell     activation, and promoting T cell differentiation, as well as regulating B cell isotype     switching to immunoglobulin (Ig) G2a. Recent studies have demonstrated that IFNγ generation     was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is     to determine if deficient IFNγ induction leads to susceptibility to HSV infection in ADEH+     patients.   "
141734|NCT01429298|"     In this randomized controlled trial, 2 mg IV hydromorphone will be more efficacious than     usual care (usual care is analgesic management according to the judgment of the attending     physician caring for that patient) in emergency department (ED) patients aged 21-64 years.     The primary efficacy outcomes are the proportion of patients in each arm who choose to forgo     additional pain medication in 30 minutes of entry into the study and the change in NRS pain     scores from baseline to 30 minutes post baseline.   "
141735|NCT01429285|"     The hydromorphone protocol is more effective than usual care in Emergency Department (ED)     patients age 65 years and older in terms of proportion who choose to forgo additional pain     medication within 60 minutes post-baseline in the two groups.   "
141736|NCT01429272|"     The purpose of this study is to determine whether Minocycline and aspirin are effective in     the treatment of depression in Bipolar patients.   "
141737|NCT01429259|"     This study will determine the concentrations of the antibiotic meropenem when administered as     a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an     acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour     infusion will be measured.   "
141738|NCT01429246|"     The study was a single-blind randomized controlled trial conducted between February and     August 2009 in two townships (Yangbajing and Gongtang) of Dangxiong County, an area at 4300     meters altitude in Tibet. A brief baseline survey and assessment for eligibility was     performed before randomization. A total of 282 residents with known hypertension (systolic     blood pressure ≥ 140mmHg) were recruited and randomly assigned to intervention or control     with stratification by gender and baseline blood pressure. The intervention group received     6-month's supply of salt substitute (68% sodium chloride, 22% potassium chloride and 10%     magnesium sulfate heptahydrate) and the control group 6-month's supply of regular salt (100%     sodium chloride). After 3-month's intervention, the ones with a blood pressure above 140 mmHg     / 90 mmHg will be given low-dose diuretic for further anti-hypertensive therapy. The study     hypothesis is that salt-substitute will greatly reduce blood pressure in treated patients     when compared to controls. Blood pressure levels were measured at baseline and followed up by     trained observers using an automated sphygmomanometer and brief survey on level of     compliance, amount of salt consumed, and reasons for non-compliance.   "
141739|NCT01429233|"     This is a Phase 4, observational, open study in patients whom their doctor for clinical     practice prescribes levamlodipine. No medication was provided by the sponsor. The planned     observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline     followed by information gathered from the assessment visits at week 4 and week 8, or clinical     practice.   "
141743|NCT01429181|"     There is a growing evidence that the d-isomer of methadone is effective in treating     neuropathic pain while the l-isomer of methadone is the only effective isomer of methadone     for treating somatic pain. This study will examine a combination of different amounts of the     d- and l-isomers of methadone specifically tailored to the chronic peripheral neuropathic     pain. Non-racemic mixture of methadone isomers will be tested in this pilot efficacy and     safety study.      This study will evaluate effect of the three doses of the non-racemic mixture of methadone     hydrochloride patients with chronic peripheral neuropathic pain compared with a placebo. The     study will also examine the minimally effective and maximally tolerated doses of the     non-racemic mixture of methadone. Finally, the safety and tolerability of the non-racemic     methadone therapy will be evaluated.   "
141744|NCT01429168|"     This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in     participants with osteoarthritis who are experiencing inadequate response to their current     treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those     participants who experience a clinically meaningful response to etoricoxib 60 mg daily within     two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders     entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or     placebo.   "
141745|NCT01429155|"     Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a     national organ shortage, living donor liver transplantation has became a viable option for     patients with end stage liver disease who are not severely ill. Recently particular     polymorphisms of IL-28B gene were reported to correlate with histological recurrence and     antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar     results have not been described yet in living donor liver transplant patients.      There is data suggesting slightly inferior outcomes in living donor liver transplants when     done for hepatitis C. The investigators postulate that such inferior outcomes may be related     to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive     similarly unfavorable polymorphism livers from their relatives).   "
141746|NCT01429142|"     The objectives of the main study are to evaluate the effectiveness and the cost-effectiveness     of a counseling intervention to support medication intake among patients treated for HIV. The     aim is that through the availability of medication intake reports collected through     electronic monitoring, more adherence problems can be identified and medical decision-making     improves.      A substudy focuses on the broader range of nursing care in HIV-treatment, examining the     content of care delivered to support physical, mental, sexual and social well-being; whether     the delivery of the AIMS intervention affects the quality of care on domains other than     adherence; and whether the content of care on these various domains can be linked to patient     well-being and satisfaction.   "
141747|NCT01429129|"     This study will examine the efficacy of mailed distribution of free Nicotine Replacement     Therapy to smokers. Telephone numbers will be randomly selected from across Canada in order     to recruit adult smokers interested in completing a smoking survey and willing to be     interviewed again in 8 weeks and 6 months time. Study participants will be asked about their     smoking history and a hypothetical question: would they be interested in receiving the     nicotine patch if this were to be provided to them free of charge? Participants expressing     interest will be randomly assigned to one of two groups. One group will be offered the     opportunity to actually receive a program of 5 weeks of the nicotine patch for free right     away and the other group will not be offered the free nicotine patches. The proportions of     smokers in the two groups who quit smoking by the 6-month interview will be compared.   "
141748|NCT01429116|"     The purpose of this study is to evaluate the safety of tasimelteon in male and female     patients who suffer from Non-24-Hour Sleep-Wake Disorder.   "
141749|NCT01429103|"     The purpose of this study is to determine if the menopausal transition is associated with     subjective and objective cognitive declines that ameliorate in menopause. The investigators     hypothesize that perimenopause is associated with both subjective memory complaints and     objective declines in attentionally mediated cognitive tasks. The investigators also     hypothesize that this is time-limited. The investigators predict that as women transition     from early perimenopause to late perimenopause their performance on attentionally mediated     and verbal memory tasks will decline, and that as they transition from late perimenopause to     menopause, their performance will improve.   "
141750|NCT01429090|"     The primary objective of the study is:      •To describe extent and rate of absorption of methantheline after single oral dose     administration of Vagantin® coated tablets (Test) in comparison to a methantheline bromide     solution (Reference)      The secondary objectives of the study are:        -  To determine elimination the half-life of methantheline bromide        -  To describe the effects of Test and Reference on salivation, accommodation, pupil          response, blood pressure and heart rate        -  to assess frequency and intensity of adverse drug reactions   "
141751|NCT01429077|"     The purpose of this study is to evaluate the effectiveness of the medication levodopa, in     combination with speech-language treatment, on the language outcome of study subjects with     nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and     written language) following a stroke.   "
141752|NCT01429064|"     The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with     castrate resistant prostate cancer.   "
141753|NCT01429051|"     The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of     intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long     term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.   "
141834|NCT01427985|"     The purpose of this study is to examine the influence of premedication drugs Atropin,     Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac     output in term and preterm newborn infants. Two different protocols of premedication are     compared.   "
141799|NCT01428440|"     Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer.     A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of     cancers. A biomarker that would allow apoptosis in tumours to be imaged directly would     provide a powerful new tool for oncology drug development and potentially contribute to     improved patient care. In this study, we propose to evaluate [18F]ML10-PET for imaging tumour     apoptosis in patients receiving standard chemotherapy treatment for their cancer.   "
141754|NCT01429038|"     The immune system of a patient can attack the liver or the kidney received from a donor     (organ rejection). This can be prevented by treating these patients long-life with     immunosuppressive drugs. Unfortunately, these drugs lead to numerous side effects and fail to     prevent the rejection occurring months later after the transplantation (chronic rejection).     Recently, it has been shown that a particular type of cells present in the bone marrow,     namely Mesenchymal Stem Cells (MSC), when injected to a patient, suppress its immune system     and increase success rates of blood cells transplantation. This outcome opens doors to     investigate the potential of these cells to provide a valuable tool for improving solid organ     transplantation without the need of high concentration of immunosuppressive drugs. The     present project aims at evaluating the safety and tolerability of MSC administration after     liver or kidney transplantation.   "
141755|NCT01429025|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.     Others interfere with the ability of cancer cells to grow and spread. Drugs used in     chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer     cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by     blocking blood flow to the cancer. Giving lenalidomide together with rituximab and     bendamustine hydrochloride may kill more cancer cells.      PURPOSE: This phase I trial studies the side effects and the best dose of giving lenalidomide     together with rituximab and bendamustine hydrochloride in treating patients with refractory     or relapsed indolent non-Hodgkin lymphoma.   "
141756|NCT01429012|"     Bone fractures heal most of the time particularly well and without complications. The     solidification takes rarely more than two to three months. The wound healing depends greatly     on a good blood supply and needs several steps. These processes culminate in a new mass of     heterogeneous tissue which is known as the fracture callus. Unfortunately, 2%-5% bone     fractures cannot achieve a proper solidification and between the ununited fragments a scar     tissue appears. This incorrect healing induces pain and even infections. When this situation     persists more than 6 months, it is referred to as nonunion fracture, which will require some     form of intervention to stimulate the natural healing process of the body. First of all, good     surgical techniques with stable immobilization should be applied and local infection should     be excluded. Then stimulation of the callus is required. Cell therapy with bone marrow cells     has emerged as a promising new approach for bone regeneration. Animal studies as well as     preliminary human studies have shown that Mesenchymal Stem Cells, a particular kind of stem     cells isolated from the bone marrow, could induce callus formation when injected in the     nonunion site of a broken bone.      In this study the investigators aim at determining whether Mesenchymal Stem Cells (MSC)     isolated from the patient's bone marrow and injected in the nonunion site could be a safe and     effective treatment for nonunion fractures. Patients will be randomized in two groups; one     injected with Mesenchymal Stem Cell and the other injected with placebo. The investigators     seek also to know how long it takes to develop the callus formation and whether there is a     partial or a complete callus formation.   "
141757|NCT01428999|"     The purpose of this study is to evaluate the effect of combined probiotics to improve the     gastrointestinal function and intestinal bacteria flora   "
141758|NCT01428986|"     This study is to investigate the safety of maraviroc by examining whether there is bone     metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone     mineral density and markers for bone formation, desorption and chemokine.   "
141759|NCT01428973|"     The present project is a multicenter phase II trail aiming at comparing which of the two     postgrafting immunosuppressive regimens proposed in this study will be best suited to prevent     graft-versus-host disease (GVDH).      The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or     Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity     conditioning with Fludarabine/total body irradiation (TBI) or     Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014, the     protocol has been amended to allow inclusion only after Flu-TBI conditioning. The hypothesis     is that the Tacrolimus plus Sirolimus regimen will be associated with better progression-free     survival due to a lower incidence of relapse/progression.   "
141760|NCT01428960|"     To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and     inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic     responses in healthy adult subjects.      Study hypothesis: The degree of fat saturation does not affect postprandial lipemia,     haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety     responses in health adult subjects.   "
141761|NCT01428947|"     The purpose of the study is to study if coronary angiography cause cognitive dysfunction.   "
141762|NCT01428934|"     Cardiovascular risk functions fail to identify more than 50% of patients who develop     cardiovascular disease. This is especially evident in the intermediate-risk patients in which     clinical management becomes difficult. The purpose of this study is to analyze if     ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose,     glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are     independently associated to incidence of vascular events and whether they can improve the     predictive capacity of current risk equations in the intermediate-risk population.   "
141770|NCT01428817|"     Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the     most common uterotonic drug used to prevent and treat PPH in North America, however, there     are some limitations to its use. Oxytocin has a very short duration of action, which requires     a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians     and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of     carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post     partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts     4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater     efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin     has not yet been published. The investigators hypothesize that the minimum effective dose     (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.   "
141835|NCT01427972|"     The purpose of this trial is to investigate the safety and efficacy of LY2623091 in males and     females with chronic kidney disease.   "
141763|NCT01428921|"     Obstructive sleep apnea (OSA) is a common sleep disorders associated with excessive daytime     sleepiness and cardiovascular disease. Continuous positive airway pressure (CPAP) therapy is     an effective standard treatment and is widely prescribed for patients with OSA. Successful     CPAP treatment has also been shown to improve cognitive, cardiovascular and metabolic     function. Sustainable CPAP treatment would alleviate the substantial cost burden of     health-related consequences of untreated OSA.      However, the use of CPAP for such patients is disappointingly low and limits the     effectiveness of treatment. Early CPAP education and follow up have shown to be very     important in helping subjects to handle side-effects or problems associated with the use of     CPAP. Good education program at the initial phase of using CPAP is essentially affected the     acceptance and adherence of CPAP therapy. Good CPAP adherence is not only medically essential     to patients' health but also economically importance to society by alleviating the     substantial cost burden of health-related consequences.      To the best of our knowledge, there is no randomized clinical trial (RCT) to prove the     long-term efficacy of extended education program on improving continuous positive airway     pressure use and its treatment outcomes.      The primary purpose of this study is to assess the long-term efficacy of our on-going RCT     which is an extended education program on improving CPAP compliance.      The investigators hypothesize that the application of both MI technique and SCT-based     extended education program at the initial phase of using CPAP also would enhance CPAP     adherence even after one year of attending education class.   "
141764|NCT01428908|"     Haemophilus influenzae is an important pathogen which can cause primary infection and     respiratory viral infection in infants and leaded to secondary infections. The infection of     haemophilus is a major cause of morbidity and mortality in infants and children. At present,     the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine     can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused     by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal     immune programming.      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus     polysaccharide vaccine with a relatively poor immune response in the infants under the age of     two, and the remaining 60% with a low antibody level and a short duration.      According to the present immunization schedule, to reach the median level of antibody levels     there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,     to provide high levels of long-term protection and to reduce the number of injections.      After the phase I study which was conducted in August, 2011, the safety profile of this     vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the     safety and the immunization of the vaccine. The objective of this study is to evaluate the     safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal     conjugate vaccine.   "
141765|NCT01428895|"     Bone is a common site of metastasis for a range of malignancies. Bone metastases have the     potential to cause significant morbidity including pain, impairment of ambulation and reduced     functional independence. Previous research has shown that pathological fractures are observed     in 9 to 29 percent of patients with long bone metastases, and a high proportion of these     require surgical intervention to relieve pain and restore function.      The goal of this study is to describe the clinical outcomes of patients with femoral     metastases at high risk of pathological fracture. Patients referred for treatment of femoral     metastases at high risk of fracture will be followed prospectively after undergoing with     surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease     characteristics, ambulatory status and limb function will be documented before treatment.     These Clinical outcomes of participants in each treatment group will be measured 6 weeks     after treatment, and 3- and 6 months after enrolment, with particular reference to     patient-reported outcomes relating to pain, ambulatory status, limb function and quality of     life.   "
141766|NCT01428882|"     Nonanesthesiologist administration of propofol for sedation is actually a field of growing     interest for endoscopists, as demonstrated by recent American and European guidelines on this     issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a single     agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation (BPS),     which combines propofol with small doses of a benzodiazepine and/or an opioid, can be     successfully titrated to moderate sedation. However, nonanesthesiologists propofol     administration remains controversial on account of the possibility of deep sedation/general     anesthesia related adverse events. On the other hand, the use of longer elimination half-life     drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and recovery.      Up to date, no study has addressed a head-to-head comparison of both regimens administered by     non-anesthesiologists and titrated to moderate sedation.      This study aims to evaluate the impact on propofol sedation of premedication with a fixed     dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate     sedation, in terms of depth of sedation, recovery times, safety and satisfaction.      The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak     effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts a     minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam may     increase the depth of sedation through the initial phases of the procedure, diminishing     propofol requirements, but not prolonging significantly recovery times.   "
141767|NCT01428869|"     The purpose of this study is to assess whether there is any interaction between statins,     acetylsalicylic acid (ASA) and dutasteride on protection from prostate cancer, the     development of high grade prostate cancer, or lower urinary tract symptoms.   "
141768|NCT01428843|"     Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This     is due to iron deficiency and inflammation.      Most of treatments aim to control inflammation using anti-TNF alpha therapy which should     theorically reduce anemia.      The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should     reduce anemia and improve quality of life of patients.   "
141769|NCT01428830|"     This facility-based, multi-center randomized controlled trial (RCT) will test the     non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14     day) urethral catheterization in terms of predicting fistula repair breakdown three months     following urinary fistula repair surgery. The study will be conducted among 507 women with     simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.   "
141772|NCT01428791|"     Linkages between depression and cardiovascular disease have been well documented. These     appear to be more than associations, and may reflect causal relationships through a number of     proposed pathways, including decreased physical activity, poor dietary habits, medication     non-adherence, and a direct impact on inflammatory mediators. Older adults are affected by     both depression and heart disease, with increased risk in African American and Latino     elderly.      The BRIGHTEN-Heart trial tests the hypothesis that an enhanced primary care delivery system     intervention which provides evidence-based, patient-centered mental health services targeting     depression and cardiovascular risk factors can reduce the risk of development of     cardiovascular disease in low-income elderly blacks and Hispanics. BRIGHTEN stands for     Bridging Resources of a Geriatric Health Team via Electronic Networking, and in this     intervention, specialty providers including geropsychologists, social workers, pharmacists,     nutritionists, chaplains, occupational therapists, and others collaborate via the internet as     a virtual team. The study will determine if such a virtual interdisciplinary clinical team     collaboration can reduce depression in older (age ≥ 65) minority adults with comorbid     depression and metabolic syndrome.   "
141773|NCT01428778|"     This prospective observational study will investigate the frequency of new onset atrial     fibrillation (AF) and of further cardiac arrhythmias as well as of (clinically silent)     cerebral lesions in endurance runners before, during and after the BMW-Berlin Marathon 2011.   "
141774|NCT01428765|"     This study constitutes Phase I of the Registry Program. The main objective of this study is     to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and     the selection of antithrombotic treatment for stroke prevention in a real-world setting     before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in     patients with non-valvular AF in different regions of the world.   "
141775|NCT01428752|"     Current guidelines for initiating screening colonoscopies in patients younger than 50 years     of age who have a first relative history of colorectal cancer are controversial. The aim of     this study was to prospectively define the prevalence of colorectal adenoma 30- to     49-years-old asymptomatic subjects with a first relative history of colorectal cancer and to     compare the data with controls.      Design: Single-center prospective study   "
141776|NCT01428739|"     Correlation between MRS and Tumor Response Therapy in Breast Cancer.   "
141777|NCT01428726|"     The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of     relapsing remitting multiple sclerosis, comparing two doses versus placebo.   "
141778|NCT01428713|"     Menorrhagia, considered a public health challenge and reported by 5 to 10% of adult women, is     encountered even more frequently in adolescents. Surveys of school students in the United     States (US) and Europe reported menorrhagia in 37% to 55% of adolescent females. Medical     management of adolescent menorrhagia includes various formulations of hormonal therapy and     the antifibrinolytic agent epsilon aminocaproic acid. Oral tranexamic acid (TA), a more     potent antifibrinolytic agent used as standard therapy for menorrhagia in adult women and in     adolescent women in Europe and Canada, was not previously available in the US. Subsequent to     US FDA approval in November 2009 of a novel oral TA formulation to treat cyclic heavy     menstrual bleeding in adult women, this medication is currently included in the treatment     armamentarium for adult menorrhagia. There is currently no preliminary data available in the     US about the clinical use of oral TA in an exclusive adolescent population with menorrhagia.     Oral contraceptive pills (OCP) are considered standard therapy in the management of     menorrhagia in teen-aged women. Oral TA has been shown to be more efficacious than     progesterone-only hormonal therapy for menorrhagia in adult women. However, there is no data     available comparing the efficacy of oral TA and combined OCP (COCP) in adult women or in     adolescents with menorrhagia.      The study hypothesis is that, in adolescent menorrhagia, oral TA will have comparable     efficacy in reducing menstrual blood loss (MBL) and improving quality of life (QOL) when     compared to the commonly prescribed COCP.      This hypothesis was tested by comparing the efficacy of these two medications, in a     prospective randomized crossover trial in post-menarchal young girls with menorrhagia.   "
141779|NCT01428700|"     Acute cellular rejection is relatively common after liver transplantation, typically does not     affect graft survival, and is not associated with the development of chronic rejection. Acute     cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated     when compared to baseline. The only means of differentiating acute rejection from other liver     pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it     may be difficult to distinguish acute rejection from another disease process, such as injury     caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether     certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver     transplant recipient can be used to determine if the transplanted liver is being rejected by     the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute     rejection and informative of the severity of HCV recurrence could allow for modulation of     immunosuppression therapy and treat the clinical condition without the need for invasive     liver biopsies.   "
141780|NCT01428687|"     A series of studies are proposed to develop an intervention to increase sleep duration and     study the effects on eating, exercise, and weight control. The hypothesis is that increasing     sleep duration will help improve weight loss and maintenance.   "
141781|NCT01428674|"     The purpose of this study is to describe the onset, duration and dose-response of     interpersonal mindful compassion on respiratory rate and heart rate variability in healthy     adults in order to prepare for research evaluating the impact of this intervention in patient     populations and to prepare for basic research investigating the CNS mechanisms for observed     effects.      Previous research has found that mindfulness meditation, including mindful compassion,     results in autonomic changes in the practitioner. Emerging neuroscience of dyadic     interactions suggests that through the effects of mirror neuron isopraxis, one person's     physiologic state may be mirrored by another. However, no research has directly evaluated the     impact of one person's mindful compassion on another person's autonomic activity. This study     paves the way for an entirely new avenue of research inquiry.   "
141782|NCT01428661|"     The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked     treatment of tasimelteon or placebo in male and female subjects with Major Depressive     Disorder.   "
141783|NCT01428648|"     Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor     tasks, affects quality of life and has been associated with depression. The purpose of this     study is to investigate the effect of dance therapy on motor performance, quality of life and     depression in PD patients, by comparing certain symptoms between a group of subjects with PD     who undergo ballroom dancing classes and a control group of subjects with PD. The     investigators will assess mental status, severity of PD, quality of life and depression using     rating scales. Subjects will be randomized to intervention and control group. Intervention     group will participate in dance therapy for 12 weeks and will be examined at 12 and 20 weeks.     Control group will be examined at same time intervals. Classes will follow a curriculum     designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate significant     risk for participants.   "
141784|NCT01428635|"     The goal of this clinical research study is learn if eltrombopag can help control or prevent     low platelet counts in patients receiving treatment for CML or myelofibrosis.   "
141785|NCT01428622|"     The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose     combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic     exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).   "
141786|NCT01428609|"     The aim of this study is to determine the blood's mercury level of patients who had amalgam     root end filling surgeries. It is to be examined if the mercury concentration in blood is     elevated by using amalgam retroseal.   "
141787|NCT01428596|"     This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The     safety and immune responses will be studied in vaccine recipients. The anti-viral effect of     HIVAX vaccine will be monitored during a 12-week treatment interruption phase.   "
141788|NCT01428583|"     The study will provide information to assess the benefits versus risks of extended exposure     to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain     population.   "
141789|NCT01428570|"     The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect     laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal     view and facilitated tracheal intubation in patients with restricted neck motion. The purpose     of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when     used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to     compare its performance with the Macintosh laryngoscope.   "
141790|NCT01428557|"     The purpose of this study is to evaluate the demographic, clinical, prognostics     characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart     failure in a group of 60 hospitals representative in different regions.   "
141791|NCT01428544|"     The purpose of this post-marketing surveillance study is to collect and assess information     retrospectively on safety and effectiveness of fondaparinux injection in patients with venous     thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom     fondaparinux was injected 10 mg/day.      (Arixtra is a trademark of the GlaxoSmithKline group of companies.)   "
141792|NCT01428531|"     The purpose of this post-marketing surveillance study is to collect and assess information on     safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).      (Arixtra is a trademark of the GlaxoSmithKline group of companies.)   "
141793|NCT01428518|"     This post-marketing surveillance study is designed to collect and assess information on     safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine     clinical practice.      (LAMICTAL is a trademark of the GlaxoSmithKline group of companies.)   "
141794|NCT01428505|"     This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial     activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET     in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender-     matched healthy volunteers.   "
141795|NCT01428492|"     Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK),     pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with     bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one     line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the     combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3     mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety,     tolerability and clinical activity of the MTD(s) identified in Part 1, including a     pharmacokinetic cohort.   "
141796|NCT01428479|"     This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete     crossover, single and multiple dose study in healthy Japanese male subjects to assess the     pharmacokinetics and safety/tolerability of single and multiple intravenous administration of     GR121167. Serial blood samples and pooled urine samples for the determination of GR121167     concentration will be collected and safety assessments will be performed for each treatment     period.      The pharmacokinetics and dose proportionality of GR121167 after single intravenous     administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed.     In addition, in the final treatment period (600 mg), twice daily intravenous administrations     for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.   "
141797|NCT01428466|"     This is a randomized, single-center, partial-blind study to evaluate the dermal irritation     potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl     peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled     water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese     healthy male and female volunteers. Finn-Chambers containing no investigational product will     be applied in the same manner.      Safety will also be assessed by measurement of vital signs, electrocardiograms, safety     laboratory data and review of adverse events.   "
141798|NCT01428453|"     The study is designed to investigate the effects of rilapladib on biomarkers related to the     Alzheimer's disease, and cognitive function.   "
141836|NCT01427959|"     Tampere Traumatic head and brain injury study is a prospective study aiming to explore     neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic     brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi.     The study is conducted in Tampere University Hospital's emergency department between the 1st     of August 2010 and 31st of July 2013.   "
141802|NCT01428401|"     Astragalus membranaceus (AM) is used to treat stroke for a long period, and a number of     studies have known that AM can reduce cerebral infarction area and has anti-oxidation.     Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase     intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present     study was to investigate the effect of AM on hemorrhagic stroke edema. The investigators     selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were     randomly divided into control and experimental groups, and each group was 40 patients as     follows: 1) control group, accepted AM placebo 2.8 g three times per day (tid) treatment for     continuously 14 days from second day of admission or operation, except standard ordinary     treatment; 2) experimental group, accepted AM 2.8 g tid treatment for continuously 14 days     from second day of admission or operation, except standard ordinary treatment. Computer     tomography (CT) examination was done at first day, 4th day and 7th day of admission,     respectively. The ratio of brain edema was calculated by CT image, and inflammatory index     including the levels of C-reactive protein (CRP), erythrocyte sedimentation rate     (ESR)，Creatine Kinase BB Isoenzyme (CMBB). D-dimer from venous blood also were measured. In     addition, the score including Glasgow outcome scale (GOS), Modified rankin scale (MRS),     Function independence measure (FIM), Barthel index (BI) was recorded one week, four weeks and     12 weeks after admission or surgical operation, as an index for clinical symptoms. The index     for the therapeutic effect of AM was according to above-mentioned the ratio of brain edema,     inflammatory index and clinical symptoms.      The investigators expected the results of the present study may provide a scientific evidence     for the hemorrhagic stroke edema treatment of AM, thus, the present study may contribute to     use the method of integrated Chinese and Western Medicine for the treatment of stroke, and to     the research of Chinese Medicine.   "
141803|NCT01428388|"     Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in     treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most     widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been     FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used     off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is     less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month     randomized, prospective interventional trial comparing the effectiveness of ranibizumab with     bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change     in central retinal thickness. Secondary measures are change in visual acuity from baseline     and change in angiographic properties of macular lesions from baseline after treatment.   "
141804|NCT01428375|"     This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of     Paracetamol as intrapartum analgesic in the first stage of labour.   "
141805|NCT01428362|"     The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and     effective as a daily treatment for Alzheimer's disease that is worsening despite current     treatment.   "
141806|NCT01428349|"     This is a 2 -year NIDA funded grant (Co-PIs: Joseph P. Newman, John Curtin, and Carl Lejuez)     that examines whether recent progress in characterizing the cognitive deficits associated     with psychopathic and externalizing offenders may be used to develop better therapeutic     interventions to treat their substance abuse and other self-control problems. Inmates with     externalizing or psychopathy will receive one of two computer-based interventions to     remediate the core cognitive skills that have been linked to self-regulation deficits in the     two groups. One intervention (ACC) targets the affective cognitive control deficits     associated with externalizing offenders whereas the other intervention (ATC) targets the     attention to context deficits associated with psychopathic offenders. The specific components     of the project include: selection and randomization of inmates; pre- and post-treatment     behavioral and brain-related (ERP and Startle) measures to evaluate the impact and     specificity of the ACC and ATC treatments; and 6 sessions of behavioral (e.g. computerized)     and verbal training in ACC or ATC.   "
141807|NCT01428336|"     The diagnosis of secondary AI is vital to prevent catastrophic events in patients. An optimal     test should have a very low margin of error with high sensitivity and specificity, be easy     and safe to administer, and have distinct cut off values. Both 1 ug and 250 ug doses have     their limitations. Based on our experience over the past six years, we hypothesize that 25 ug     ACTH stimulation test may eliminate some of the shortcomings of the LDST (1 ug) and SDST (250     ug). This is supported by our preliminary data and the study by Oelkers et al, which looked     at ACTH levels following various doses of cortrosyn injections.      Therefore we propose a head to head comparison of 25 ug, 250 ug and 1 ug dose using ITT as     gold standard.   "
141808|NCT01428323|"     Open-vent jet nebulizers are frequently used to promote drug lung deposition but their     clinical efficacy and indications are not clear.      Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet     nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a     110 ml corrugated piece of tubing.   "
141809|NCT01428310|"     This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the     effects of study product on a smoker's desire to smoke, measured by changes in scores on     questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will     self-administer the study product and visit the study site for assessment of desire to smoke     and collection of samples for the evaluation of smoking-related biomarkers.   "
141810|NCT01428297|"     The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in     Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be     assessed in two different patients groups to evaluate safety and efficacy in atopic     dermatitis (Part 2) and in Netherton syndrome (Part 3).   "
141812|NCT01428271|"     Caudal block is one of the most useful and popular regional block in pediatric anesthetic     practice. Successful caudal block depends on the proper placement of a needle through sacral     hiatus by following anatomical landmarks. The sacrum and the position of sacral hiatus are     extreme variable anatomical structure. Generally, the equilateral triangle located between     the apex of the sacral hiatus and posterior superior iliac spines is used in determining the     location of the sacral hiatus as the conventional method. Previous study demonstrated that     the triangle formed between the apex of the sacral hiatus and the posterior superior iliac     spines was found to have the features of an equilateral triangle in adult. There is no study     about the efficacy of the conventional method using the equilateral triangle in children. In     this study, the investigators will compare between the expected site of sacral hiatus by     conventional method using the equilateral triangle and the real site of the sacral hiatus     confirmed by ultrasonography for caudal block in children.   "
141855|NCT01427699|"     The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that     blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be     looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by     blocking inflammation in the pancreas.   "
141814|NCT01428245|"     Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the     pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone     (FSH). LH and FSH control the production of female hormones (such as estrogen and     progesterone) and the development of eggs by the ovary. Progesterone and estrogen then     decrease the number of GnRH pulses produced by the brain (and therefore the number of LH     pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important     for normal menstrual function in adult women. The purpose of this study is to learn more     about how GnRH and LH pulses are controlled during puberty. The information gathered in this     study will hopefully allow us to learn more about how menstrual cycles are normally     established in girls during puberty.   "
141815|NCT01428232|"     A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo     to compare rates of early initiation and exclusive breastfeeding between mothers who give     birth in hospitals with the current standard of care, mothers who give birth in hospitals     that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and     mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly     Hospital Initiative, with the 10th step being the provision of breastfeeding support during     well-child clinic visits.   "
141816|NCT01428219|"     The purpose of this study is to look at the effects of cabozantinib on castrate-resistant     prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone     and to learn about any side effects caused by taking cabozantinib.   "
141817|NCT01428206|"     Liverpool Care Pathway for the dying patient (LCP) was developed to transfer the care     practice from the hospice setting to the hospital setting in UK. LCP is a pathway with     standardized registration method to monitor the care and its results. The primary aim is to     study the effects of LCP on dying patients symptom burden and communication with close     relatives and health care professionals.   "
141818|NCT01428193|"     The purpose of this study is to understand the effects of elevated male hormones in     adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If     the investigators understand the effects of elevated male hormones levels in girls, the     investigators may be able to better treat girls with elevated male hormone levels and perhaps     even learn how to prevent the development of PCOS. Females with elevated levels of male     hormones respond differently to estrace (estradiol) and progesterone than females with normal     male hormone levels. The investigators will be giving you estrogen and progesterone to see     how you respond after the male hormone has been blocked by a medication called flutamide.   "
141819|NCT01428180|"     The purpose of this study is to examine the influence medical or surgical treatment for     patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on     cardiac output.   "
141820|NCT01428167|"     Thyroid cancer (TC) is the most common endocrine malignancy. The association between     inflammation and cancer is well established but the association between thyroiditis     (inflammation of thyroid gland) especially Hashimoto's thyroiditis (HT) and thyroid cancer     remains controversial. Chronic inflammation leads to a repeated cycle of cellular damage and     subsequent healing which contributes to inappropriate cell proliferation and subsequent     neoplastic transformation. One of the most common forms of Thyroiditis is Hashimoto's     thyroiditis which is a chronic autoimmune inflammatory disease affects almost 5% of the     population and is more common in women. For the first time, Dailey and Lindsay reported in     1955 an increased association between Hashimoto's Thyroiditis (HT) and thyroid cancer. They     reported 35 thyroid cancers in 278 patients with Hashimoto's Thyroiditis, a prevalence of     17.7% which they considered higher than the general population . Since then, various studies     have been done, some studies have reported an increased risk of malignancy in Hashimoto's     thyroiditis; others have failed to find an association. Most of the studies that have been     done to identify the association between Hashimoto's thyroiditis and thyroid cancer are     retrospective. The purpose of this pilot case-control study is to identify the association of     Hashimoto's thyroiditis and thyroid cancer, to determine if the presence of Hashimoto's     thyroiditis has any affect on the complication of thyroidectomy and prognostic factors of     thyroid cancer.   "
141821|NCT01428154|"     The purpose of this study is to find out more about darbepoetin alfa in children less than 1     year of age with anemia (a decrease in red blood cells) due to kidney failure. This study     will see if darbepoetin alfa is safe and well tolerated and whether it causes any side     effects by taking blood samples and checking vital signs (heart rate, body temperature, and     blood pressure tests) at specific times throughout the study. In addition, the study will     evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in     the blood to evaluate how darbepoetin alfa works on anemia.      Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and     European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric     subjects. Therefore, studies need to be conducted in pediatric subjects (children) to     determine the appropriate dose to use in younger children.   "
141823|NCT01428128|"     Many types of cancer are treated with chemotherapy drugs and/or radiation therapy. These     forms of treatment, however, can also damage normal (non-cancer) cells and cause a variety of     side effects. There are many side effects of chemotherapy. A few examples are: lowered red     blood cell counts (anemia) which can lead to tiredness, weakness or shortness of breath;     lowered white cell counts (white blood cells which help the body to fight infection); low     platelet counts (platelets help blood to clot); nausea and vomiting; diarrhea; lip and mouth     sores and hair loss. These side effects can range from mild to severe. P53 is a protein in     the body that regulates the cell cycle. If a cell becomes damaged from chemotherapy or     radiation treatment, the p53 protein becomes activated. This activation can cause the cell to     die and is involved in causing side effects from chemotherapy or radiation therapy.      Arsenic trioxide is a drug that is currently approved by the FDA (Food and Drug     Administration) for the treatment of acute promyelocytic leukemia (APL), which is a type of     blood and bone marrow cancer. It is given by I.V (intravenous, by vein). New preclinical     studies have shown that when given in smaller than normal doses before treatment with     chemotherapy and/or radiation therapy, the arsenic trioxide can block the activation of p53     and protect normal tissues from treatment damage. Preclinical means that the studies have     been done in a laboratory and not on humans.      This study has two purposes. The first is to find the dose range for arsenic trioxide that     will block p53 activity. This dose has been determined from the first five subjects who took     part in the study and received arsenic trioxide. The dose of arsenic trioxide for this study     is about 1/30 of the normal dose given when arsenic trioxide is used to treat acute     promyelocytic leukemia. The second is to see if the arsenic trioxide will decrease the side     effects of chemotherapy. In this study, arsenic trioxide is investigational.     Investigational means that arsenic trioxide has not yet been approved by the FDA to block     p53 activity.      This study will help find out what the smallest (best) dose is that can be given and the     effects, good and/or bad, this drug has on people who take it. The safety of this drug in     humans has been tested in prior research studies; however, whether the side effects will     still be present at this lower dose is not yet known.   "
141871|NCT01427491|"     The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to     manage bioburden in leg ulcers over a two week study period.   "
141824|NCT01428115|"     It has been shown that emotional health issues, such as state anxiety, are more prevalent in     patients suffering from inflammatory bowel disease (IBD) compared to physically healthy     subjects.      Such findings have to be taken into consideration when making an educated guess that     psychological factors such as depression and anxiety in particular interact with the course     of Crohns disease. Therefore the treatment of the underlying disease may have a significant     influence on the level of psychological disorders.      Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies     ameliorates the emotional/psychological status of patients, however the impact of adalimumab     therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains     unclear.      The primary objective of this study was to describe and evaluate changes in levels of anxiety     assessed by validated patient questionnaires after 6 months of treatment with adalimumab.   "
141825|NCT01428102|"     During normal physiological conditions hemostasis (the ability of blood to clot) is kept in     homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex     series of steps on both sides of the coagulation cascade including cellular components (i.e.     clot formation and breakdown). However, should this homeostatic balance be upset, normal     hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding     (hemorrhage). In instances that include acquired or congenital abnormalities of the     hemostatic system it is clinically important to diagnose, monitor and manage the patient to     optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis     system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain     the homeostatic balance.      The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets     with the protein coagulation cascade from the time of placing the blood in the analyzer until     initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via GPIIb/IIIa,     through eventual clot lysis. It displays both qualitatively and quantitatively the two     distinct parts of hemostasis - the part that produces the clot and the part that causes the     breakdown of the clot. It shows the balance or degree of imbalance in the patient's     hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of     the patient's hemostasis condition. If the system is not in balance, one can see where the     imbalance lies. If a patient is bleeding, it is crucial to determine the cause of bleeding as     soon as possible in order to start the proper treatment.      By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the     interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways     which initiate and result in clot formation. This RapidTEG™ reagent can deliver results     faster than activating with Kaolin alone. This protocol will specifically assess one     algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and     platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot.     This represents platelet function.      The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs.     MA Kaolin.   "
141826|NCT01428089|"     During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH),     luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are     very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they     initially do so at night only. It is unknown why GnRH and LH pulses increase at night and     then decrease during the day (instead of being increased all the time). The purpose of this     study is to see how quickly progesterone reduces LH pulses. The study is also meant to find     out whether too much testosterone (also a hormone) in the blood causes problems with the     ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover     whether or not giving 3 small doses of progesterone to pubertal girls will prevent the     nighttime increase of LH pulses. From the information gathered in this study, the     investigators may be able to learn more about how menstrual cycles are normally established     in girls during puberty. Ultimately, if the investigators understand these normal processes,     the investigators may be able to better understand abnormalities of puberty.   "
141827|NCT01428076|"     Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and     may cause discomfort. In this study, patients with varicose veins in the legs will be     participating. The purpose of this research study is to evaluate the pharmacokinetic profile     of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an     investigational treatment for varicose veins.   "
141828|NCT01428063|"     The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received     placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and     determine whether addition of these drugs results in higher cure rates in patients who     previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS     study NCT01428063 (AI447-028) will receive active drugs in this study.   "
141829|NCT01428050|"     The Whipple operation is a complex surgical procedure involving the removal of the head of     the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for     patients who have cancer or some other condition affecting this region of the body. The     Whipple operation is associated with a significant complication rate. Previous studies have     shown that in a broad range of surgical procedures, using a reduced amount of intravenous     fluids along with a special type of fluid called hypertonic saline during and after the     procedure can lower complication rates associated with the heart and lungs during recovery     from surgery. The purpose of this study is to determine if using a reduced amount of     intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous     fluids) during the Whipple operation and in the immediate period after surgery can reduce     complications.   "
141830|NCT01428037|"     The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal     misoprostol for cervical ripening and induction of labour.   "
141839|NCT01427920|"     This trial was conducted in Asia, Europe and South America. The aim of this trial was to     confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin     aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in     glycosylated haemoglobin (HbA1c).   "
141840|NCT01427907|"     The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and     sevelamer carbonate in maintaining serum phosphorus levels      This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the     equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer     carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim     of the study is to maintain serum phosphorus level and establish equivalence between COS and     sevelamer carbonate tablets.   "
141841|NCT01427894|"     Study objective is to evaluate the additive effect of maternal singing during skin to skin     contact (Kangaroo Care) on anxiety reduction both to infants and their mothers.   "
141872|NCT01427478|"     The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance     therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2     every 3 weeks)in squamous cell carcinoma of the head and neck.   "
141842|NCT01427881|"     This phase II trial studies how well cyclophosphamide works in preventing chronic     graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients     with hematological malignancies. Giving chemotherapy and total-body irradiation before     transplantation helps stop the growth of cancer cells and prevents the patient's immune     system from rejecting the donor's stem cells. Healthy stem cells from a donor that are     infused into the patient help the patient's bone marrow make blood cells; red blood cells,     white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause     an immune response against the body's normal cells, which is called graft-versus-host disease     (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make     chronic GVHD less severe.   "
141843|NCT01427868|"     The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of     LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg)     tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.   "
141844|NCT01427855|"     There is growing epidemiological evidence that consumption of red meat is associated with     greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods.     Research from our group has shown that a high saturated fat (SF) diet with a moderate red     meat content selectively increases intermediate density lipoproteins (IDL) and larger low     density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller     LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef     consumption results in a preferential increase in small and medium LDL particles that are     strongly related to CVD. To date, no studies have directly compared the lipoprotein effects     of red meat with that of other food sources of protein in the context of both high and low     saturated fat intake.      The overall objective of this project is to test the hypothesis that the effects of SF on     lipoprotein markers of CVD risk are influenced by sources of dietary protein. The     investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C),     apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high     content of red meat than in diets in which the major proteins are from white meat (poultry)     or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and     women will be randomized to high SF or low SF diet groups, and within each group, consume     diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for     4 wks each in random order. Specifically, the investigators will test whether: (1) With high     SF, the red meat diet, compared to the other protein sources, will result in higher levels of     LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low     SF, dietary protein source will not be related to any of these measurements; (3) With both     the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due     primarily to increases in large LDL, whereas with red meat the additional increase in small     and medium LDL will result in greater increases in plasma apoB and total LDL particle number.     Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat     are related to increased activity of hepatic lipase, a key determinant of small LDL     production, and that increases in large LDL induced by high SF are related to suppression of     LDL receptors. The investigators will also assess the effects of protein source and saturated     fat content on markers of insulin resistance, inflammation and endothelial function.   "
141845|NCT01427842|"     Current Australian guidelines for vancomycin commonly underdoses individuals particularly in     the first 48 hours.      The aim of the trial is to compare two dosing regimens; the current Australian guidelines     versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of     developing a new vancomycin dosing strategy that will enable patients to have more     individualised and therapeutically efficacious treatment.      The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen     increases the likelihood of achieving therapeutic trough levels of vancomycin within the     first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin     according to the current Antibiotic guidelines.   "
141846|NCT01427829|"     The purpose of this study was to examine preliminary effect of Computer-assisted Psychosocial     Risk Assessment tool (CaPRA) among Afghan refugees visiting medical professionals (family     physicians or nurse practitioners) at a Community Health Center. The investigators examined     the tool's acceptability among patients and its impact on patient satisfaction and patient     intention to visit a psychosocial counselor as a proxy of potential to integrate medical and     social care.   "
141847|NCT01427816|"     To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye     syndrome.   "
141848|NCT01427803|"     An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of     Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the     frequency at which consumers exceed the label-defined daily dose, thus putting themselves at     clinical risk, and 2) the reasons for exceeding the labeled daily dose.   "
141849|NCT01427777|"     The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1     Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male     subjects aged 9 to 15 years.   "
141850|NCT01427764|"     Periodontal instrumentation aims to remove plaque and calculus from the root surface. Both     manual and ultrasonic instruments have been used for such decontamination; however,     establishing a healthy periodontium can result in adverse effects, such as dentin     hypersensitivity. The aim of this study was to evaluate the effects of hand or ultrasonic     instrumentation on dentin hypersensitivity in patients undergoing non-surgical periodontal     treatment. For this controlled clinical trial of a split mouth design, 14 patients were     selected with homologous teeth in the incisor to premolar region and probing depth ≥ 5 mm on     the buccal aspect of the teeth. One side (control) was instrumented with hand instruments and     the other side (test) with ultrasonic instruments. Dentin hypersensitivity was assessed in     the baseline and during the follow 4 weeks after treatment, with a periodontal probe     scratching the root surface and with an air jet. The patient's response was detected by a     visual analog scale (VAS) of 10 cm.   "
141851|NCT01427751|"     This study will evaluate the safety and efficacy of dexamethasone intravitreal implant     (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion     (BRVO).   "
141852|NCT01427738|"     The purpose of this study was to see which one of two medicines (topical gentian violet [GV]     or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC).     This was measured by whether the study participant still had OC or sores in his/her mouth     after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment     of OC were assessed.   "
141853|NCT01427725|"     This study aims at collecting the information related to the safety and effectiveness in the     pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long     term in order to evaluate the effective and safe use of LipaCreon.   "
141854|NCT01427712|"     This study aims at collecting the information related to the safety and effectiveness in the     pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment     with LipaCreon in order to evaluate the effective and safe use of LipaCreon.   "
142615|NCT01417767|"     The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine,     homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk     myelodysplastic syndromes(MDS).   "
141856|NCT01427686|"     The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in     term and preterm neonates with arterial hypotension on cerebral and renal oxygenation,     fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.      The investigators hypothesize that Dopamine has a stronger effect on blood pressure than     Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output     than Dopamine.   "
141857|NCT01427673|"     The purpose of this study is to determine if Bipap should assume a standard-of-care role in     the management of overlap syndrome.   "
141858|NCT01427660|"     Two of AHRQ 's consumer-focused guides, Pills for Type 2 Diabetes and Premixed Insulin for     Type 2 Diabetes could be of great use to underserved ethnic and racial minority adults. The     presentation of content and delivery mechanisms of these Guides, however, needs to be     modified to increase their use and impact among these difficult-to-reach populations.      To achieve this goal, a long-standing collaboration among African American and Latino     community organizations, health care centers and systems, public health organizations, and     academics (the REACH Detroit Partnership) is joining with leading experts in the development     of personally and culturally tailored health decision aids (University of Michigan's Center     for Health Communications Research [CHCR] and Center for Behavioral and Decision Sciences in     Medicine [CBDSM]).      The investigators will develop and evaluate a computer tailored online diabetes medication     decision aid that will enable community health workers (CHWs) to provide personalized patient     education materials to underserved diabetic African American and Latino adults in Detroit,     Michigan.   "
141859|NCT01427647|"     Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative     outcome following colorectal cancer surgery. The investigators hypothesize that the     inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared     to traditional open surgery under general anesthesia.   "
141860|NCT01427634|"     The primary aim of the study is to provide proof of concept to demonstrate that patients     with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a     randomized trial of palliative care and that such a study is feasible. Secondary aims include     demonstrating improvement in symptoms (physical and psychological) for intervention patients     and their caregivers as compared to control patients and caregivers. The investigators will     also examine differences in utilization of healthcare services, mortality, and completion of     advance directives between intervention and control patients.   "
141861|NCT01427621|"     Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the     postoperative course of the patients. The investigators hypothesized that RIPCcom, combined     intervention of remote ischemic preconditioning and remote ischemic postconditioning, would     confer beneficial influence on inflammatory response and resultant postoperative pulmonary     dysfunction after CPB in patients undergoing complex valvular heart surgery who are at     increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate     the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients     undergoing complex valvular heart surgery.   "
141862|NCT01427608|"     The acute phase of this study will monitor the response to a combination of an atypical     antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute     treatment of the disorder. It is predicted that this combination will improve symptoms of     psychotic depression and be associated metabolic side effects. Factors that moderate     tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks,     followed by a period of 8 weeks during which participants will continue to take the same     medications to stabilize the remission from symptoms of psychotic depression.      The maintenance phase will be a randomized, double-blind, placebo-controlled study of     olanzapine for a period of up to 36 weeks to test whether continuing this combination     decreases the risk of relapse and whether discontinuing the combination leads to improvement     in metabolic measures. Subjects who complete the acute phase will be asked to consent     separately to the randomized maintenance phase.   "
141863|NCT01427595|"     Many, but not all, girls with high levels of the male hormone testosterone go on to develop     polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual     periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of     difficulty becoming pregnant. The investigators do not understand why some girls with high     hormones develop PCOS and others do not. In a previous study by our group, some girls with     high levels of male hormones had abnormalities in the secretion of another hormone, called     luteinizing hormone (LH), that are often seen in women with PCOS. However, another group had     normal LH secretion. The girls with the abnormal LH secretion had higher levels of another     hormone, called insulin, than the girls with normal LH secretion. The investigators will test     whether metformin, an insulin-sensitizing agent, changes the effects of high male hormone     levels in adolescent girls, specifically by looking at their LH secretion response following     metformin treatment.   "
141864|NCT01427582|"     The YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program provides     patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials     with YONDELIS (trabectedin), access to this investigational treatment.   "
141869|NCT01427517|"     The investigators are interested in determining if the investigators are able to detect     changes in brain chemistry using Magnetic Resonance Spectroscopy (MRS) in individuals with     Parkinson's disease (PD), those with Gaucher's disease (GD), and those without neurological     disorders (healthy controls) when they are given the antioxidant N-acetylcysteine (NAC). This     study will combine information from a medical history, a physical examination and disease     rating scales with results obtained using MRS brain scans and pharmacokinetic studies from     blood samples. This research will require 1 visit that will require about 4 to 5 hours of     time. During this study, participants will provide their medical history, be examined and     undergo a rating scale for about one hour; the brain scan and pharmacokinetic studies will     require 1.5-2 hours of time; in total the study will take about 4-5 hours.   "
141870|NCT01427504|"     The investigators believe that boceprevir's drug concentrations will be reduced when     administered in combination with etravirine. The investigators believe that etravirine's drug     concentrations will be increased when administered in combination with boceprevir.     Additionally, the investigators believe that boceprevir and etravirine are safe when     administered alone or in combination.   "
141873|NCT01427465|"     The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse     prevention strategies that integrate positive youth development messages and health risk     messages for adolescents in high school settings. A secondary aim is to examine these     strategies in various combinations as interventions and re-interventions (i.e., boosters) for     sustaining or enhancing behavior change over time. These strategies are founded upon an     emerging conceptual framework titled the Behavior-Image Model emanating from findings of our     recent trials examining multiple behavior health interventions. The long-term objective of     this project is to reduce alcohol abuse and problems among older high-risk adolescents for     whom alcohol and drug use disparities exist, yet who are often overlooked in prevention     research and services.   "
141874|NCT01427452|"     Live donor kidney transplantation (LDKT) is important because its outcomes for recipients are     superior to those of deceased donor transplantation, and it yields significant cost savings     to the healthcare system overall. Despite efforts over the past few decades to enhance     understanding of the short- and long-term outcomes of living kidney donation, it is clear     that investigators have more knowledge in some areas (e.g., surgical and medical     complications) than in others (e.g., psychological outcomes, financial impact). While the     transplant community and changes in federal regulations have brought attention to the need     for more systematic study of living donor outcomes, there remains a paucity of scientifically     rigorous multisite, prospective outcome studies. The long-term goal of this research program     is to characterize the short- and long-term surgical, medical, functional, psychological, and     financial outcomes of living kidney donation. The objective of this study is to establish a     multisite prospective cohort of living kidney donors, their recipients, and a healthy     comparison group. This cohort will be used to examine three primary aims: (1) to assess donor     outcomes (surgical, medical, functional, psychological, financial) over a 2-year period     initially, with the intention of examining these outcomes over a more extended time period in     subsequent years; (2) to identify the donor, recipient, and center variables that are most     predictive of donor outcomes; and (3) to identify disparities in donor outcomes and their     predictors. To accomplish these aims, six kidney transplant programs, representing six states     (Massachusetts, Maine, Rhode Island, New York, Iowa, and Arizona) and with experience and     expertise in caring for living donors and transplant recipients, will participate in the     study. Donors, their recipients, and healthy controls will complete comprehensive assessments     at baseline (pre-surgery) and at 1, 6, 12, and 24 months post-donation. This study will     extend the investigators considerable preliminary work by simultaneously examining outcomes     that are of importance to donors, recipients, healthcare providers, and policymakers. The     rationale for this research is that, once these outcomes and their predictors are known,     investigators can further develop and refine educational strategies and informed consent     processes for both living donors and their intended recipients, as well as provide systematic     data to inform policy discussions and clinical care practice.   "
141875|NCT01427439|"     The purpose of this study is to describe patient functioning and examine associations between     depressive symptoms and measures of the various roles of functioning.   "
141876|NCT01427426|"     Factors Group is a producer of nutritional supplements. This study aims to determine whether     one of their products improves the energy and sense of well-being in individuals who consume     it. Interested subjects will complete a 1 week lead-in phase where they will be asked to     consume a placebo daily to see if they are a good fit for the study. After the lead-in phase,     subjects will be randomized to take either All Greens or a different placebo for 12 weeks.     The investigators expect All Greens to have better results than the placebo, but subjects     will not know which supplement they are taking. The primary outcome is a score on a     questionnaire of well being.   "
141877|NCT01427413|"     While the number of assisted reproduction cycles increases worldwide, the introduction of     actual technological improvements in the ability to quickly and non-invasively identify the     best embryos for transfer still represents a critical goal for reproductive medicine. Indeed,     embryo assessment is currently performed through the analysis of morphology and cleavage     rate. Recent studies have sought to identify a correlation between qualitative-quantitative     profiles of small molecules of metabolic interest and the outcome of embryo transfer. Some of     these molecules seem to be best suited for this purpose, including glucose, lactate, pyruvate     or amino acid levels. Approaches relying on both optical and non-optical spectroscopy have     been proposed to non-invasively monitor the embryo culture media. However, the non-invasive     approach only offers an indirect strategy to monitor embryos and a turn-around solution to     bypass the limits of detection of these analytical techniques. In this paper the     investigators pave the way for direct assessment of embryos through the mass     spectrometry-based analysis of blastocoele fluid, which is withdrawn from the blastocoele     cavity prior to cryostorage of blastocysts. The investigators show how it is possible to     detect most of the already documented metabolites of interest right at the very heart of the     blastocyst, without disrupting the workflow of a classic laboratory pipeline.   "
141917|NCT01426893|"     The correct use of inhalation devices is an inclusion criterion for all studies comparing     inhaled treatments. In real life, however, patients may make many errors with their usual     inhalation device, which may negate the benefits observed in clinical trials. In real life,     many errors seem to be made, but no wide-scale evaluation has been performed. The correct use     of inhalation devices is essential to ensure the effectiveness of the treatment. It has been     recently demonstrated that inhaler misuse is associated with decreased asthma control in     asthmatics treated with an inhaled corticosteroid. The aim of our observational study was to     evaluate the inhaler device usage in patients with asthma or chronic obstructive pulmonary     disease (COPD).   "
141878|NCT01427400|"     Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures     performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these     breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory     results can be achieved with a single-stage technique, a two-stage approach is considered     more reliable, allowing for precise positioning of the inframammary fold and an opportune     time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue.      The placement of the tissue expander and implant under the chest muscles is thought to     minimize the incidence of capsular contracture, expander exposure, and in addition, produce     acceptable aesthetic results. However, discomfort is often associated with this submuscular     placement of a tissue expander or implant, specifically during the expansion phase. Patients     undergoing immediate reconstruction using submuscular implants have been shown to have higher     analgesic requirements and to have higher pain scores post-operatively, compared to     non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the     expander, a longer expansion process, abandonment of reconstruction, and a compromised     quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at     the time of surgery may help ease the discomfort that is often associated with this     procedure.      The investigators propose a prospective double-blind randomized placebo-controlled trial of     patients undergoing tissue expander/implant reconstruction. The information gathered from     this analysis will provide a greater understanding of the effects of Botox in the setting of     two-stage tissue expander/implant breast reconstruction, with the goal to improve patient     satisfaction and quality of life.   "
141879|NCT01427387|"     A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of     multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition,     pre-prandial and postprandial administrations, is compared.   "
142035|NCT01425333|"     The aim of this study is to assess which of two commonly used surgical procedures in the     treatment of ovarian cysts called endometriomas (cutting out of the cyst - cystectomy, or     draining it and cauterising it's inner lining - ablation) causes the least damage to the     ovary and is therefore best at maintaining the future fertility potential of a patient.   "
141880|NCT01427374|"     Individuals with kidney disease are at a higher risk for heart and vascular diseases,     including heart attacks and strokes, than those with normal kidney function. The purpose of     this research study is to collect information on the causes, complications and treatment of     kidney disease. Patient characteristics, comorbid diseases and laboratory markers used in     routine practice, as well as novel biochemical markers and genetic data will be collected to     examine relationships between biochemical and genetic markers and cardiovascular risk.     Information on the health history of incident hemodialysis and peritoneal dialysis patients     will be captured using structured patient interviews and review of medical records. Blood and     urine specimens will be collected at the time of dialysis initiation and stored in order to     perform novel biochemical and genetic assays in the future. The overall goal of the     CKDCS/LUCID study is improve understanding of cardiac-associated risks and to improve     treatment in patients with kidney disease. A cardiac imaging substudy will be performed in a     subset of patients enrolled. The goals of the substudy are to examine whether the risks of     developing common cardiac-related complications (coronary artery calcification [CAC] and left     ventricular hypertrophy [LVH]) are associated with certain medications taken by individuals     on dialysis and whether these risks are modified by a genotypic predisposition.   "
141881|NCT01427361|"     The primary objective of this study is to investigate the accuracy of the femoral implant     placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing     (BHR) surgery postoperatively after total hip resurfacing using the BHR System.   "
141882|NCT01427348|"     The purpose of this study is to determine whether the head extension by an assistant     decreases dental contact between laryngoscope blade and maxillary incisors during direct     laryngoscopy   "
141883|NCT01427335|"     There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous     calcium is a novel protocol. But still there is lack of evidence of it is real effect in     prevention of OHSS & the mechanism of its action is still questionable . In the study the     investigators try to search for the evidence for its effect & the real mechanism for its     action.   "
141884|NCT01427322|"     Lapatinib will prevent radiation-induced increase in Transforming Growth Factor alpha (TGFα),     an important growth factor in cancer cell recovery after ionizing irradiation.   "
141885|NCT01427309|"     The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard     dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza     types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for     culture-confirmed) to those contained in the respective annual vaccine formulations.      Primary Objective:        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly          adults, with respect to laboratory-confirmed influenza caused by any influenza viral          types/subtypes, associated with the occurrence of a protocol-defined          influenza-like-illnesses (ILI).      Secondary Objectives:        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly          adults, with respect to laboratory-confirmed influenza, caused by any influenza viral          types/subtypes, associated with the occurrence of a protocol-defined ILI.        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly          adults, with respect to culture-confirmed influenza, caused by any influenza viral          types/subtypes, associated with the occurrence of a protocol-defined ILI.        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly          adults, with respect to culture-confirmed influenza caused by viral types/subtypes          antigenically similar to those contained in the respective annual vaccine formulations,          associated with the occurrence of a modified Centers for Disease Control and Prevention          (CDC)-defined ILI.        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly          adults, with respect to culture-confirmed influenza caused by any influenza viral          types/subtypes, associated with the occurrence of a modified CDC-defined ILI.        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly          adults, with respect to culture-confirmed influenza caused by viral types/subtypes          antigenically similar to those contained in the respective annual vaccine formulations,          associated with the occurrence of a respiratory illness.        -  To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly          adults, with respect to culture-confirmed influenza caused by any influenza viral          types/subtypes, associated with the occurrence of a respiratory illness.   "
141886|NCT01427296|"     The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus     HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.   "
141887|NCT01427283|"     The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release     tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone     controlled-release tablets (OXY) in subjects with moderate to severe low back pain and     opioid-induced constipation who require around-the-clock opioid therapy.   "
141888|NCT01427270|"     The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the     management of opioid-induced constipation (OIC) compared to oxycodone controlled-release     tablets (OXY) in subjects with moderate to severe low back pain and OIC who require     around-the-clock opioid therapy.   "
141889|NCT01427257|"     Primary objective:      To compare the pharmacokinetic profile of PB1023 after a single dose administered by     subcutaneous injection of two formulations (concentrations).      Secondary objectives:      To evaluate the safety and tolerability of two formulations of PB1023 Injection administered     as a subcutaneous injection in adult subjects with T2DM.      To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of     formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.   "
141890|NCT01427244|"     This is a phase II open-label study of the activity and safety of trastuzumab in patients     with vulvar Paget's disease with overexpression of HER2 on biopsy.   "
141891|NCT01427231|"     The objective of the current study is to determine the acute effect of a glucose drink and a     sacharose drink compared to a placebo on cognitive performance in elderly with light memory     complaints. The investigators expect that the sugar containing drinks will improve memory and     attentional functions. Furthermore, blood glucose response will be measured.   "
141961|NCT01426308|"     The study will determine the performance of the Infinium HD Test.        -  The primary objective of the study is to assess the performance of the Infinium HD Test          using banked DNA samples extracted from whole blood patient samples derived from the          intended use population.        -  The secondary objective of the study is to determine the background number of          chromosomal abnormalities per person in the general population based on the resolution          of the Infinium HD Test.   "
141892|NCT01427218|"     Existing trials for the patient with coronary heart disease evaluate the interdisciplinary     team dynamic where pharmacists (pharmacotherapists) provide therapeutic recommendations in     the inpatient environment. To our knowledge, only other trial has evaluated the addition of a     pharmacist (or nurse practitioner) in an outpatient collaborative cardiology practice and has     found no benefit. However, the investigators believe that since a cardiology based pharmacist     (pharmacotherapist) in the Veterans Health Administration has physical assessment skills, a     shorter cycle length between appointments, and the ability to provide medication therapy     management, the pharmacotherapist should be similarly successful as seen with other     pharmacist based medication therapy management practices. The investigators will assess     effectiveness by using the combined endpoint of blood pressure and lipid treatment.     Additionally the investigators will conduct three substudies to evaluate if the pharmacist     can improve all cause mortality and cardiovascular morbidity, adherence to antihypertensives,     and patient satisfaction.   "
142036|NCT01425320|"     This study will investigate the pharmacokinetics, safety and tolerability of dapsone and     adapalene following topical administration of 2 formulations of dapsone/adapalene fixed     combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects     with acne vulgaris.   "
141893|NCT01427205|"     The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab     can improve response. The safety of these drugs will also be studied.      Objectives:      Primary Objective(s): To assess progression-free survival (PFS) among patients with head and     neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and     compare it with PFS among patients treated with cetuximab plus placebo.      Secondary Objective(s):        -  To assess the safety and toxicity of these treatment regimens.        -  To assess the efficacy of these two treatment regimens in terms of overall survival,          response rate, and disease control rate        -  To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of          response rate and disease control rate in patients who cross-over from Arm B to receive          single-agent OSI-906        -  To explore blood-based and tissue biomarkers   "
141894|NCT01427192|"     The purpose of this study is to study the differential short-term effect of nocturnal oxygen,     acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms,     exercise capacity and nocturnal breathing disturbances in subjects with pulmonary     hypertension and sleep related breathing disorders        -  Trial with medicinal product   "
141895|NCT01427179|"     The purpose of the research is to identify mutations (defects in the genetic blueprint) that     cause spontaneous coronary artery dissection (SCAD), in other words, spontaneous tears in     blood vessels that supply the heart.      Some mutations may be inherited (passed on) from a parent without an apparent blood vessel     problem while others may develop for the first time in the affected person.   "
141896|NCT01427166|"     To date, the scientific literature has yet to provide sufficient evidence regarding the     pathophysiology of cording. The objective of this protocol is to evaluate the utility of non     invasive vascular imaging for assessing the pathophysiology of cording in a small study     cohort of patients who were treated for breast cancer. The hypothesis is that cording may     have a vascular etiology   "
141897|NCT01427153|"     The purpose of this study is to compare an orthopaedic manual physical therapy (OMPT) to     corticosteroid injection for the management of knee osteoarthritis.   "
141898|NCT01427140|"     The purpose of this study is to investigate the metabolic consequences of a moderate weight     gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects     in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight     gain.   "
141899|NCT01427127|"     Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies     reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel     syndrome. The investigators examine the effect of ramosetron used for preventing     postoperative nausea and vomiting on bowel motility.   "
141900|NCT01427114|"     The purpose of this study is to determine how efficient the combination of rituximab,     cyclophosphamide, vincristine, and prednisolone (R-CVP) is in the treatment of stage I or II     non-conjunctival ocular adnexal MALT lymphoma (OAML).   "
141901|NCT01427101|"     The aim of this study was to compare debulking surgery and cytoreductive surgery in patients     with Pseudomyxoma Peritonei with respect to efficacy and safety.   "
141902|NCT01427088|"     This study aims at investigating the neuroplastic potential and the possible factors     affecting rehabilitation in chronic schizophrenia patients on stable medication, by     investigating the cumulative pattern of serum BDNF representing the neuroplasticity in the     brain, through quantitative stimulus such as rTMS.   "
141903|NCT01427075|"     This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for     treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.   "
141904|NCT01427062|"     Falling is a complex and most disabling feature for patients with Parkinson's disease (PD).     Previous studies suggested that falls in patients with PD are related to postural instability     characterized by deficits in anticipatory postural adjustment (APA) for postural orientation     in walking and standing and inadequate postural response to perturbation. The present study     developed an innovative balance treatment with focus of anticipatory and compensatory     postural control and examined its effects on enhancing balance and gait performance and     decreasing fall rate in people with PD.   "
141905|NCT01427049|"     Hypertension is a major and growing public health concern. Chronic elevation of sympathetic     nervous system (SNS) activity has been identified as a major contributor to the complex     pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role     in the elevation of the SNS activity. Therapeutic renal denervation (RD), the deliberate     disruption of the nerves connecting the kidneys with the central nervous system, has been     shown to be an effective means of modulating elevated SNS activity - both by reducing the     sympathetic modulation of renal function (renin release, sodium excretion and renal blood     flow) and by removing the renal afferent sympathetic contribution to central blood pressure     elevation.      This current study is an observational exploratory study. The main objective of this study is     to learn more on the effects of RD. We wish to do that by quantifying the effects of RD on     various biological variables. Those variables are studied in four sets of investigations: a     radiological set, a laboratorial set, a set of blood pressure measurements and a set of     investigations in the vascular laboratory. The radiological set consists of imaging of the     heart and kidney function (renal perfusion) and structure (renal arteries), the laboratorial     set of serum and urine tests, 24 h- home- and office- blood pressure measurements will be     taken and finally the set of vascular tests contains investigations on pulse wave     velocity(PWV) and heart rate variability(HRV). The data will most likely help us to define     future studies, to describe the mode of action and the effects of RD on various organs and     systems in more detail, and finally to define in more detail which type of hypertensive     patients is especially likely to benefit of the procedure.      Hypothesis:        -  We hypothesize that LV mass will decrease after RD. Because all patients have severe          hypertension, it is likely that a substantial percentage will have increased LV mass.        -  We hypothesize that renal perfusion and renal oxygenation increase after RD.        -  We hypothesize that there will be no complications related to the device or procedure.        -  We hypothesize that renal denervation has a beneficial effect on insulin resistance        -  We hypothesize that renal denervation will decrease the blood pressure(office and          24-hour-measurements)        -  We hypothesize that RD has a beneficial effect on PWV and HRV.   "
141906|NCT01427036|"     Fractures of the trochanter in the elderly have a terrible prognosis both vital and     functional. It is certainly possible to reduce the medical and economic impact of this     disease by reducing surgical trauma, by means of minimally invasive osteosynthesis material     adapted to this approach. This minimally invasive approach should, however, guarantee a     result at least equal to the standard approach. The goal is to have a technique, easily to     transmit, using a percutaneous approach, but which may be converted to conventional surgery     in case of difficulty, and with implants appropriate for trochanteric fractures.      With this in mind, the dynamic hip screw MISS® (Minimally Invasive Screw System) was     developed and has already demonstrated its effectiveness in terms of anatomical results. It     is as effective than the PHS® hip screw design for standard approach. The two implants have     the same plate and screw and differ only by the system for fixing the screw on the plate to     allow minimal invasive approach.   "
141908|NCT01427010|"     Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced     toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This     could also be of importance in IMRT for recurrent and second primary head and neck cancers in     previously irradiated territory.      This trial investigates the feasibility of continuous adaptive     18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel)     intensity-based IMRT in reirradiation of patients with recurrent and second primary head and     neck cancer.   "
141909|NCT01426997|"     To facilitate the development of a personalized approach to the treatment of patients with     major depression, this study is designed to elaborate the clinical and neurobiological     phenotype of depressed patients with increased inflammation. The data obtained in this     proposal will allow the investigators to test the hypothesis that depression and inflammation     interact to elaborate a relatively discreet phenotype that warrants an individualized     approach to diagnosis and treatment of patients with depression. Moreover, the identification     of specific environmental risk factors for inflammation will foster the elaboration of     preventative strategies for patients at risk.   "
141910|NCT01426984|"     The study assesses the effect of Ritalin on working memory,attention,and decision-making     measures in adults with BPD and compares it to its effect on healthy adults and adults with     BPD (using data form study SHA 01-10), in a double-blind crossover design. The investigators     hypothesize that Ritalin will result in better performance in all measures.   "
141911|NCT01426971|"     Primary Objective:      - To compare the treatment groups in the reduction of pain score by at least 30 mm on a     visual pain scale (VAS) at 60 minutes after study medication intake, compared to the baseline     score (obtained before the study medication intake).      Secondary Objectives:        -  To assess the proportion of patients with more than 50% pain relief, according to the          VAS score at 45 minutes after study medication intake compared to baseline        -  Determine the following aspects in the timing of study medication intake:             -  Time to the first perception of pain relief             -  Time to onset of meaningful pain relief             -  Reduction of pain at 15, 30, 45, 60, 120 and 240 minutes after study medication               intake, to be evaluated as the difference between the scores on VAS in each period               and baseline        -  To assess the pain according to the five items of Headache Relief Rating - HRR (0:          strong worsening 1: slight worsening 2: no change 3: slight improvement 4: strong          improvement) at 15, 30, 45 and 60 minutes after study medication intake, according to          the diaries completed by the patients        -  To check the proportion of the patients requiring the third tablet of study medication          within 24 hours of starting the study treatment and when it occurred        -  To check the timing and frequency of rescue medication intake, as well as the proportion          of patients who used these medications within 24 hours of starting the treatment        -  Safety assessment.   "
141912|NCT01426958|"     To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of     afatinib depending on the timepoint of ritonavir administration   "
141913|NCT01426945|"     RATIONALE: Studying tissue samples from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial studies protein expression in samples from young patients with     rhabdomyosarcoma.   "
141914|NCT01426932|"     The alternate binaural bithermal caloric test (ABBT) is a well established examination in the     evaluation of the dizzy patient. ABBT is useful in detecting the side of peripheral     vestibulopathy by stimulating each ear separately, it contributes to the diagnosis of     bilateral vestibular involvement when all responses to cold and warm stimuli are reduced, and     adds to the differentiation of peripheral from central vestibular involvement by measuring     the fixation-induced inhibition of the caloric response. In spite of these benefits, ABBT is     the most time-consuming part of the electronystagmography/Videonystagmography (ENG/VNG) test     battery, and frequently causes significant inconvenience to the patient due to the repeated     extreme vestibular stimuli.      The head impulse test (HIT) assesses vestibular function by brisk, passive rotations of the     head in the plane of the examined semicircular canals. Whenever the vestibulo-ocular reflex     (VOR) is deficient, this maneuver would produce catch-up saccades aiming to the re-fixation     of the eyes on the target. Hence, both residual VOR and catch-up saccades act synergistically     to stabilize gaze. The HIT requires only several minutes and might cause minimal discomfort     only.      The study hypothesis is that the HIT recorded by standard VNG equipment of the VNG system     would provide diagnostic information on the side of vestibular involvement matching that of     the ABBT.   "
141915|NCT01426919|"     The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP     Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma     Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to     assist in determining the need for a CT scan of the head.   "
141916|NCT01426906|"     A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole     or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male     Volunteers.   "
141918|NCT01426880|"     Study participants with primary breast cancer will receive a standard chemotherapy with an     anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses     and duration in concordance to current treatment guidelines. Patients will be receive and     benefit in addition currently not in the neoadjuvant setting registered medication as     lapatinib or bevacizumab of which significant increases of cure (pCR) rates have been     reported in previous phase III studies. Patients randomized to carboplatin will receive in     addition to the described backbone therapies a potentially active agent which suggested     synergy of efficacy with chemotherapies as well as targeted agents. Patients might have the     risk of an increase in toxicities due to the added agents and will have additional burden due     to investigations required for study participation. However, due to the severity of the     underlying disease and the high risk of relapse and death due to the stage of disease, this     increase in toxicity and burden appears less relevant compared to the potential higher     efficacy and finally cure rate by the incorporated treatments.   "
142616|NCT01417754|"     To investigate if there are detectable changes in volume and circulation in breasts of     healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus     nonmedicated cycle.   "
141921|NCT01426841|"     This study is intended to assess the feasibility of adjusting a radiation plan during its     course to accommodate for a shrinking tumor target. The investigators hypothesize that an     adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with     chest-confined disease will allow for safe delivery of higher doses of chest RT than a     non-adaptive RT planning approach without subjecting normal critical structures to     unacceptable doses of radiotherapy.   "
141922|NCT01426828|"     This study will enroll myeloma subjects undergoing autotransplantation. The primary objective     of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous     lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28     activated autologous lymphocytes. There will be 2 arms in the study, one receiving a DLI with     non Id-KLH vaccine and one receiving aDLI with Id-KLH vaccine.   "
141923|NCT01426815|"     In this Investigator Initiated study, the investigators want to explore the potential of an     induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease     stage (less than 3 months of symptom duration) of patients with predominant peripheral     spondyloarthritis (SpA), classified according to the new Assessment of SpondyloArthritis     (ASAS)-criteria. The hypothesis would be that treatment with a TNF-blocker at this early     (immature) stage of the disease would result in a significant higher number of patients in     clinical remission compared to placebo, and that - comparable to the early Rheumatoid     Arthritis (RA) patients in the BeSt-study - long-term treatment would not be necessary to     maintain this remission in a number of patients.      In this placebo-controlled, double blind, randomized study (with open-label phase, starting     at week 24) sixty patients fulfilling the Assessment of SpondyloArthritis (ASAS) criteria of     peripheral spondylarthritis will be enrolled. Patients will be randomized in a 2:1 ratio (2     golimumab :1 placebo). During the placebo-controlled phase, 50mg golimumab, or placebo will     be administrated subcutaneously (SC) every 4 weeks through week 20. Subjects will be treated     with open-label Golimumab 50 mg SC injections at weeks 24, 28, 32, 36, 40, 44, and 48. If     patients are in 'clinical remission' (clinical remission is defined by the absence of     arthritis, enthesitis and dactylitis clinically at two major consecutive visits. Visits are     planned at week 12, week 24, week 36 and week 48) then the treatment will be stopped. In case     of clinical relapse, patients will be treated with open-label golimumab 50 mg SC. Patients in     sustained clinical remission will be observed to assess the possibility of maintaining     drug-free remission. The study duration will be 48 weeks.   "
141924|NCT01426802|"     The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg     bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.   "
141925|NCT01426789|"     This study aims to confirm if patients with a specific biomarker might have a better response     to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done.     The goals of these exploratory studies are to (1) find biomarkers that will identify persons     with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to     identify persons who will have fewer side effects in order to maximize their benefit from     secukinumab.   "
141926|NCT01426776|"     Sleep disordered breathing, especially central sleep apnea, is common in patients with     chronic heart failure. Heart valve replacement could have some effect on central sleep apnea.     The aim of the study is to investigate effect of heart valve replacement on Cheyne-Stokes     respiration in patients with rheumatic heart disease.   "
141927|NCT01426763|"     The objectives of the study are to:        1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with          recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE)          who previously participated in CINRYZE Study 0624-200 (NCT01095497)        2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered          CINRYZE with rHuPH20        3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of          CINRYZE with rHuPH20   "
141928|NCT01426750|"     CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status     of cancer patients, leading to nutritional support. The aim was to study enteral nutrition     indications, as well as its compliance and the impact on nutritional status.      DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year     followed during anticancer therapy were included from January 2002 to January 2004. They     received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a     weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was     observed, tube feeding with the same supplement (TFR) was indicated.   "
141929|NCT01426737|"     The purpose of this study is to explore long term glucose variability of a combination     therapy of metformin and vildagliptin compared to a metformin - gliclazide combination.      Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration.        -  Trial with medicinal product   "
141930|NCT01426724|"     Active forms of vitamin D and its analogs are used to treat elevated parathyroid hormone     levels and bone disease in chronic kidney disease (CKD). More recent animal and human studies     suggest that treatment with vitamin D may be associated with reduction of inflammation and     urinary protein loss as well as reduction the activity of the renin angiotensin system (RAS)     in addition to its effects on the bone metabolism. The investigators of this study have used     the new technique of contrast enhanced ultrasound (CEU) to measure the flow of blood to the     kidney in other human studies. In this study, the investigators will investigate if 3 month     of treatment with an active form of vitamin D in individuals with kidney disease and high     parathyroid hormone levels would reduce protein loss in the urine. The investigators will     also look at the potential changes in blood flow to the kidney using CEU, kidney function     (GFR), inflammation and activity of RAS in response to treatment with active form of vitamin     D. Finally, they will examine the association between reduction of protein loss in the urine     as shown in other studies with any of the other factors measured (e.g, change in blood flow     or inflammation).   "
141940|NCT01426594|"     This is a Phase 4, observational, open study in patients who their doctor has prescribe     METPURE XL (S (-)metoprolol succinate)by clinical practice. No medication was provided by the     sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an     evaluation of baseline followed by information gathered from the assessment visits at week 4     and week 8.   "
141931|NCT01426711|"     The care of patients with sepsis and trauma requires the delivery of appropriate definitive     care in the early stages of the illness. Hospitals with limited resources, those in rural and     underserved areas of South Carolina, may be unable to consistently provide optimal care to     these patients. In addition, the shortage of specialists nationally makes it more difficult     for these hospitals to recruit and retain the specialists needed. Patients in these areas     continue to pay the rural penalty of poorer outcomes. This study provides specialists' level     care through telemedicine consults to rural emergency departments in rural areas of SC to     improve outcomes for these patients.      The CREST study is a project that specifically addresses the need to bring health care to     rural communities in SC, as well as evaluates methods and tests technology to implement this     care in rural communities. The CREST study uses telemedicine remotely from MUSC to rural     community hospitals to provide rural community physicians care from specialists for trauma     and sepsis, which are both high acuity, difficult to treat conditions.      CREST is a multi-site trial of telemedicine services to meet rural patients' and providers'     need for expert evaluation and management of sepsis and trauma. The specific aims of CREST     are:        1. To test the hypothesis that a telemedicine program including education and clinical          consultation between a tertiary care academic medical center and rural, local hospitals          will significantly improve key treatment decisions and outcome measures in sepsis and          trauma.        2. To test the hypothesis that the differences in ISS and time to antibiotics for trauma          and sepsis patients exposed to telemedicine intervention and those without the          intervention matched on propensity scores are not due to unmeasured confounders.      CREST seeks new solutions to rural health disparities, to advance technology, create and     retain jobs and address important research opportunities by combining implementation of a     novel, trans disciplinary clinical program with rigorous, mixed methods scientific evaluation     including clinical, process, and economic outcome measures. The impact on both science and     quality healthcare outcomes is broad and CREST has far reaching implications for addressing     rural health disparities for acute, life-threatening illnesses.   "
141932|NCT01426698|"     The purpose of this study is to examine differences in the long-term effects of immediate     versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22     months corrected age.   "
141933|NCT01426685|"     The study will include 1200 patients with type 2 diabetes and angiographically documented     coronary artery disease and 600 matched non-diabetic patients without type 2 diabetes.     Extensive traditional and novel risk marker tests are performed for the patients and they     will be followed-up for 5 years. Sudden cardiac death is the main outcome measure and various     other endpoints are secondary endpoints. As a substudy, 120 diabetic patients and 120     non-diabetic patients will undergo exercise training with home monitoring to assess the     effects of exercise training on risk profiles.   "
141934|NCT01426672|"     PURPOSE:      The purpose of this study is to quantitatively assess the efficacy of monovision correction     in the treatment of acquired small angle binocular diplopia in adult patients.      METHOD:      Twenty patients with symptomatic diplopia were enrolled in a prospective treatment trial. All     had stable deviations of 10 prism diopters or less for over three months. Each received     monovision spectacles and/ or contact lenses with distance correction in the dominant eye.     Half received a +3.00 diopter (D) add and the others received +2.50 D. The validated and     standardized Diplopia Questionnaire and Amblyopia and Strabismus Questionnaire (ASQE) were     used to quantify the efficacy of monovision correction for diplopia by measuring the     functional impact on vision-specific quality of life.   "
141935|NCT01426659|"     The preterm children have more difficulty minor neurological developmental than the general     population even without cerebral palsy. Their oral language difficulties of language and     writing have been little studied. The investigators propose to study spoken language has 3     years 1/2 and stimulate or not (depending on randomization) children with phonological     weaknesses notemment language. The investigators will evaluate stimulation protocol implied     short and precise language in a re-education say and do in 20 sessions. A new evaluation of     language (BILO and N-EEL), sensorimotor and cognitive constraints (KABC) will be performed at     4 years.      Early intervention on the basis of precise language before closing the window developmental     (<5 years) is expected to improve as a result of language and cognitive development of     preterm infants.   "
141936|NCT01426646|"     Although there has been some progress in chemotherapy for metastatic gastric cancer, no     standard regimen of adjuvant chemotherapy is available, and many clinical trials have     produced contradictory results. The majority of randomized clinical trials studying adjuvant     chemotherapy in gastric cancer have been underpowered, involved low-volume centers, or used     ineffective chemotherapy regimens. As a result, well-designed multicenter trials are still     needed. The ACTS-GC trial, which demonstrated the efficacy of S-1 for stage II-III gastric     cancer patients who underwent curative resection with extended lymph-node dissection (D2),     may be valid in countries where D2 surgery is considered the standard of care. S-1 improved     the 3-year overall survival from 70.1% for surgery alone to 80.1%. However, 3-year overall     survival in stage IIIA and stage IIIB patients receiving S-1 were 77.4% and 63.4%,     respectively, which are less satisfactory compared to the rate for stage II (90.7%). Based on     the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial, further     investigation is needed for more effective postoperative treatment of patients with stage     IIIB and IV (M0) cancer. Therefore, the researchers investigated the efficacy and safety of     S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively resected     gastric adenocarcinoma.   "
141962|NCT01426295|"     The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in     addition to standard oral care (strategy A) is cost-effective in the prevention and treatment     of severe mucositis in adult patients with auto or allograft packaging without ICT versus     mouthwashes standard bicarbonates with an antiseptic (strategy B).   "
141963|NCT01426282|"     The purpose of this study is to evaluate the effects of health education given by nurse on     out-patient compliance in cardiovascular diseases prevention and treatment.   "
141937|NCT01426633|"     L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and     12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment     armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with     anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas     (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been     described for the use of gemcitabine and especially the combination of gemcitabine and     docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of     gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and     refractory peripheral oedema are the most common severe adverse events. The aim of the     present phase I study will be to examine safety data of this promising treatment combination     of gemcitabine and trabectedin in L-sarcomas.   "
141938|NCT01426620|"     This phase II trial will evaluate phyto-therapy's, in the form of blueberry powder,     synergistic effect on second-line therapy for non-small cell lung cancer (NSCLC). The     proposition is that the addition of blueberry polyphenolics to routine docetaxel therapy will     have a significant, positive effect in the response rate and overall survival.   "
141941|NCT01426581|"     The purpose of this study is to evaluate the relative effectiveness of two different ways to     teach subjects while hospitalized how to use respiratory inhalers and to follow-up after     discharge home from the hospital to determine durability of the education.      Teach-to-Goal (TTG) education employs instruction followed by patient teach-back, then     repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief     Intervention (BI) education only consists of providing the patient with verbal and written     instruction.      The investigators hypothesize that hospital-based TTG compared to BI increases a patient's     ability to retain instructions on respiratory inhaler technique. The investigators will test     this hypothesis separately for the MDI and Diskus® devices after discharge.   "
141942|NCT01426568|"     The purpose of this study is to determine whether multi-convergent therapy is helpful to     patients with inflammatory bowel disease who have functional abdominal symptoms or high     perceived levels of psychological stress.   "
141943|NCT01426555|"     This is a research study to determine the effects of functional electrical stimulation (FES)     rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if     zoledronic acid treatment will increase bone mineral density in persons with chronic spinal     cord injury (SCI) who received it. The investigators also want to find out if zoledronic acid     is safe for persons with SCI to take without causing too many side effects.   "
141944|NCT01426542|"     Newborn babies with congenital heart disease often require surgery in the first month of     life. The risks of brain damage from congenital heart disease and from the various corrective     surgeries are high because of poor levels of oxygen reaching the brain. Topiramate is an     anti-convulsant medication that protects brain cells from damage due to low amounts of oxygen     in animal studies. The investigators hypothesize that giving topiramate to babies with     congenital heart disease before and after surgery will decrease the amount of brain damage     caused by the heart disease and/or the surgery to correct the heart disease.   "
141945|NCT01426529|"     Caveolin-1 and Vascular Dysfunction      Thank you for your interest in the investigators Blood Pressure Research Study. The National     Institutes of Health are sponsoring us to investigate why patients develop high blood     pressure, atherosclerosis (hardening of the arteries), and heart disease. There are two parts     of the investigators research program. The first part is a screening visit. At this visit you     will be given a brief physical exam and will be asked questions concerning your medical     history. During the same visit you will have your blood drawn for routine screening and     genetic testing. You will also be asked to collect a urine sample for routine screening.      If the doctor finds that you are a healthy candidate you will be invited to participate in     the second part of the study. During Phase II, the investigators will perform physiological     tests after you are placed on a low salt diet and again after you are placed on a higher salt     diet. If you are on blood pressure medication, it may be necessary to discontinue taking your     present medication for up to three months before beginning the study. Patients discontinuing     their current blood pressure medication may be placed on a different blood pressure     medication during this 'washout' period if necessary to maintain blood pressure at pre-study     levels.      Once your blood pressure medications are discontinued, you will be closely monitored. If you     do not own a home blood pressure monitor, the investigators will provide one for you to use     during the study so that you can keep a daily record of your blood pressure readings. The     investigators will ask you to call us every three days to report your blood pressure     readings. After you have stopped taking your medication, dieticians at the hospital will make     you low salt meals to eat at home for about seven days. On the last day of the low salt diet,     you will be asked to begin a 24-hour urine collection that you will bring with you when you     are admitted to the hospital that evening. That morning, you will be required to come to the     Center for Clinical Investigations (CCI) at Brigham and Women's Hospital for a one-hour test     to check if your body is in the correct salt balance.      You will return that evening to the CCI where you will be admitted for your study that will     occur the next morning. On the morning of your low salt study, the investigators will collect     some blood samples. The investigators will also take ultrasound pictures of your heart to see     how salt and hormones affect the way your heart and blood vessels functions. These tests will     last approximately 5 hours and you will be discharged around 2:00 PM. For the next 5-7 days,     you will be placed on a high salt diet. During this diet period, you will eat all your own     food, but the investigators will give you some supplements to add to your meals. After 5-7     days on your high salt diet, on the morning of your second admission to the hospital, you     will be asked to begin a final 24-hour urine collection. That morning, you will again be     required to come to the CCI for a blood test, and you will return later that evening to the     inpatient CCI where you will be admitted for your final overnight study. The same study that     was done for the low salt diet will be repeated for the high salt study. You will be     discharged at around 2:00 p.m. These studies will help to determine if you are     salt-sensitive. In addition, the investigators hope to learn more about the hormones that     regulate your blood pressure and the genes responsible for regulating those hormones.      You will have the option to spend a second night in the CCI after each diet phase in order to     participate in an optional study of the blood vessels in the arm. This study also uses an     ultrasound machine. It will last about 2 hours in the morning.      You will be placed back on your initial blood pressure medication (if you are on any) and     returned to your regular physician for care. The investigators can also provide clinically     relevant information to you.   "
141946|NCT01426516|"     One-third or more of individuals treated for major depressive disorder (MDD) do not     experience remission of symptoms despite at least two adequate antidepressant trials. Such     treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs     of MDD, in terms of health care costs, functional impairment, and diminished quality of life.      The promise of personalized medicine for individuals at high risk for TRD is apparent. If     these individuals could be recognized early in their disease course, they could be triaged to     more intensive or targeted interventions to improve their likelihood of remission. With the     proliferation of treatment options in MDD, at present individuals can spend months or years     in and out of treatment before receiving these next-step treatments.      At present, no clinical or biomarker-based tool has been shown to assist in matching patients     with treatments most likely to be effective for them. The Genecept Assay offers the     possibility of Personalized Medicine in psychiatry. Clinicians may find this additional     genetic information can lead to optimized treatment plans for individual patients. Before     such an assay can be widely applied clinically, it is necessary to demonstrate that this tool     usefully impacts treatment outcomes.      This study will examine the potential impact of the assay in terms of depression severity at     3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate     of its potential to change clinician behavior and improve patient quality of life. Further     measures will also allow for refinement of the assay to maximize patient and clinician     satisfaction, and estimate the potential savings associated with deployment of this assay in     real-world clinical settings.   "
141964|NCT01426269|"     The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea     during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen     of Oracea® and MetroGel® 1%.   "
141965|NCT01426256|"     The purpose of this study is determine if high-dose vitamin D supplementation improves     clinical outcomes related to lung function and immunity in patients with Cystic Fibrosis who     are admitted to the hospital with an acute lung infection.   "
142008|NCT01425684|"     The principle aim of the project is to identify the key brain circuits associated with     smoking and especially smoking in high risk population. The investigators hope that the study     will provide concrete biomarkers for new therapeutic development and ultimately reducing the     smoking related health burden.   "
142009|NCT01425671|"     The principle aim of the project is to analyze brain electrical activity and genetic     information that will help identify the nature and cause of the disease schizophrenia. This     effort should lay the groundwork for future treatment in schizophrenic patients.   "
141947|NCT01426490|"     Vitamin B-6, folate and homocysteine may play a critical role in the colorectal cancer     progression. This is a 4-y study and the specific aims are: 1) to compare vitamin B-6, folate     and homocysteine status, oxidative stress, antioxidant activities and DNA methylation between     subjects with colorectal polyps and colorectal cancer; 2) to study the effects of vitamin     B-6, folate and homocysteine status on oxidative stress, antioxidant activities and DNA     methylation in colorectal cancer patients; 3) to evaluate whether folic acid and/or     pyridoxine supplementation had a beneficial effect on oxidative stress, antioxidant     activities and DNA methylation in patients with colorectal; 4) to compare vitamin B-6, folate     and homocysteine status, oxidative stress, antioxidant activities and DNA methylation between     colorectal cancer patients and age-, sex-matched healthy subjects; 5) to evaluate the effect     of vitamin B-6, folate and homocysteine status, oxidative stress, antioxidant activities and     DNA methylation on the risk of colorectal cancer (odds ratio); 6) to follow the effects of     vitamin B-6, folate and homocysteine status, oxidative stress, antioxidant activities and DNA     methylation on the occurrence of colorectal cancer; 7) to follow the effects of pyridoxine     and/or folic acid supplementation on the occurrence of colorectal cancer.      This protocol is designed as a hospital-based cross-sectional, case-control, double blinded     randomized placebo-controlled intervention and follow-up trial. Three hundred colorectal     cancer patients and 300 age-, sex-matched controls who meet the inclusion criteria will be     recruited from Taichung General Veterans Hospital. If cancer patients' plasma pyridoxal     5'-phosphate (PLP) level less than 30 nmol/L will be asked to participate the intervention     study and will be blinded and randomly assigned to either the 1) control (vitamin C, 100     mg/d); 2) 50 mg vitamin B-6; 3) 400 microgram/d folic acid; or 4) vitamin B-6 (50 mg/d) plus     folic acid (400 microgram/d) for 1 year. Data on demography, anthropometry, medical history,     food frequency questionnaire and 24-h diet recall will be collected. Cancer patients will     have fasting blood drawn before surgery or receiving chemotherapy. Additionally, fasting     blood samples will be obtained at month 0, 3, 6, 9 and 12 during intervention period and at     month 6, 12, 18, 24, 30, 36, 42 and 48 during follow-up. Hematological, plasma and     erythrocyte PLP, plasma pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum     vitamin B-12, homocysteine, SAM, SAH, lipid peroxidation indicators (TBARS, oxidized LDL),     glutathione, antioxidant enzymatic activities and DNA methylation and MTHFR 677C>T     polymorphism will be measured.   "
141948|NCT01426477|"     The main study objective is to determine the frequency of hernia recurrence following use of     Veritas Collagen Matrix.   "
141949|NCT01426464|"     The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular     pressure (IOP) utilizing an experimental lotion containing 0.005% Latanoprost that is applied     to the outside of one eyelid.   "
141950|NCT01426451|"     The purpose of this study is to determine whether a drama workshop program for immigrant and     refugee youth is effective in reducing impairment in high school students presenting learning     difficulties.   "
141951|NCT01426438|"     This study is being done with people with HIV infection who have low levels of HDL-C. HDL-C     is a type of good cholesterol. People with low HDL-C have a higher risk of heart disease     and may have problems with how their blood vessels relax. The endothelium is the inner lining     of all blood vessels, such as arteries and veins. When the endothelium is not working     properly, the blood vessels have trouble expanding properly, which contributes to the     development of heart and blood vessel disease.      The main purpose of this study is to see if taking either extended-release niacin or     fenofibrate for 24 weeks will help blood vessels work better by improving endothelial     function and increasing HDL-C. Niacin and fenofibrate are medications that raise HDL-C. This     study will also help determine how safe extended-release niacin and fenofibrate are.      The analysis is an as-treated analysis of participants who completed study treatment and had     a week 24 BART scan. Safety analyses include all participants   "
141952|NCT01426425|"     ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a     prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational     clinical study. The purpose of this clinical study is to demonstrate the safety and     effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the     conducting tissues of the heart in the treatment of patients with atrioventricular nodal     reentrant tachycardia (AVNRT) using an endocardial approach.   "
141953|NCT01426412|"     This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low     density lipoprotein cholesterol (LDL-C). Following single doses of LY3015014, the safety and     tolerability of the drug, how the body handles the drug, and the drug's effect on the body     will be evaluated. Participants will remain in the study for approximately up to 6 months.   "
141954|NCT01426399|"     The objective of the study was to investigate the drug-drug interaction between LC15-0444 and     metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy     male subjets after oral administration concomitantly and each alone.   "
141955|NCT01426386|"     This trial investigates the effects of several doses of FE 999049 in women undergoing     IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.   "
141956|NCT01426373|"     To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area     (below the chin).   "
141957|NCT01426360|"     The objective of the present study was to compare the effects of a commercially available     dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base, versus     a control dentifrice, containing exactly the same ingredients apart from strontium chloride     and potassium nitrate, on the instant and lasting relief of DH.   "
141958|NCT01426347|"     The purpose of this study is to investigate the effect of vitamin D repletion on disease     activity and disability in patients with rheumatoid arthritis.      The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D     deficiency have greater disease activity and disability, compared to RA patients with normal     vitamin D levels. The investigators also hypothesize that vitamin D treatment in these     deficient patients will result in a decrease in RA disease activity and disability.   "
141959|NCT01426334|"     This phase I trial studies the side effects and the best way to give dasatinib and     cyclosporine in treating patients with chronic myelogenous leukemia (CML) refractory or     intolerant to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by     making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine     may be an effective treatment for CML.   "
141960|NCT01426321|"     For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a     major improvement. The treatment improves symptoms and prolongs life in selected patients     with heart failure. However, with the current selection criteria and methods for implanting     the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.      New imaging techniques, including advanced ultrasound and computed tomography, in combination     with new versatile multi-pole electrodes, have made an individually tailored therapy     possible. Using these techniques in combination, the study will investigate the effect of     individually based optimal placement of the pacemaker electrodes vs. standard care. The     optimal LV electrode position is defined as pacing a viable segment with the latest     mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac     CT. The hypothesis is that this will increase the number of positive responders from 65% to     85%.   "
141966|NCT01426243|"     Main objective :      To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever     Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative     individuals who had not been given YFV before.      Secondary objectives :        -  To develop and assess ELISPOT technology for yellow fever and to measure the response          within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects          and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy          (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months)          in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3)          neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference          method) and a new pseudotype based method, (4) post-vaccination viremia and (5)          diversity of viral quasi-species.        -  To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and          viral load.   "
141967|NCT01426230|"     Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical     practice   "
141968|NCT01426204|"     This is a Phase 4, descriptive, observational, open, prospective study of patients who their     doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor.     The planned observation time is 48 weeks and 24 weeks of follow-up.      Each investigator participating in this registry will employ his or her discretion and     standard clinical practice to determine when to see the patient in the clinic, how to manage     the patient's drug regimen, and how best to monitor the patient's response and tolerance to     therapy.   "
141969|NCT01426191|"     In the proposed study, the investigators plan to evaluate the efficacy and safety of     Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory     and urinary tract acute bacterial infection under the widely used in clinical conditions.   "
141971|NCT01426165|"     Hypomagnesemia (low magnesium) is an electrolyte imbalance commonly found in up to 65% of     critically ill patients. Possible consequences of hypomagnesemia include neuromuscular and     neurologic dysfunction, heart arrhythmias, and alterations in other electrolytes. Data has     shown that critically ill patients with hypomagnesemia have a significantly higher mortality     rate than patients with a normal magnesium level. The most simple and commonly used test to     diagnose hypomagnesemia is a serum magnesium level. Based on the magnesium level and symptoms     of hypomagnesemia, patients may be replaced with either oral or intravenous (IV) magnesium.     When replacing magnesium via the IV route, approximately half of the dose is retained by the     body while the remainder is excreted in the urine. The low retention rate is due to the slow     uptake of magnesium by cells and decreased magnesium reabsorption by the kidneys in response     to the delivery of a large concentration of magnesium. The purpose of this study is to     determine whether an eight hour compared to a four hour infusion of IV magnesium sulfate     results in a greater retention of the magnesium dose.   "
141972|NCT01426152|"     Progesterone levels measured in blood/serum of patients on the day of ovulation induction     following controlled ovarian stimulation for in vitro fertilization may be associated with     pregnancy outcome. The hypothesis is that higher progesterone levels are associated with     lower implantation rates due to changes in the endometrial receptivity.   "
141973|NCT01426139|"     The objective of this clinical investigation is to assess the safety and clinical performance     of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary     artery lesions.   "
141974|NCT01426126|"     Taxane-based chemotherapy is currently one of the most commonly used regimen for salvage     chemotherapy in advanced urothelial carcinoma. In previously untreated patients, single-agent     paclitaxel, administered in a 24-hour infusion, produced an overall response rate of 42%, and     single-agent docetaxel as a first-line therapy produced response rates of 31% and 45% in 11     patients with impaired renal function. Of the two taxanes, paclitaxel has been studied more     extensively.      Intravenous administration of paclitaxel requires the use of solubilizing agents such as     Cremophor EL (CrEL) due to its hydrophobicity. CrEL often contributes to hypersensitivity     reactions including hypotension or dyspnea with bronchospasm, some of which are major and     potentially life-threatening. Minor allergic reactions such as transient rashes and flushing     also may occur. Despite pretreatment with corticosteroids and histamine antagonists, minor     reactions still occur in 10-44% of all patients, with 1-3% of patients experiencing     potentially fatal reactions. CrEL may also act as a potential cofactor for the development of     peripheral neuropathy. In addition, special infusion sets must be used clinically when     administering CrEL-based paclitaxel.      Genexol-PM (Samyang Co., Seoul, Korea), a form of paclitaxel formulated with sterile,     lyophilized polymeric micells that allow intravenous delivery of paclitaxel without CrEL. The     polymeric micelle formulation is composed of hundreds of low molecular weight, nontoxic, and     biodegradable amphiphilic diblock copolymers which include monomethoxy poly(ethylene     glycol)-block-poly(D,L-lactide), and has a great potential in terms of water solubility, in     vivo stability, and the nanoscopic size (a diameter of 20-50 nm) of the micellar structure.      A phase I study established that Genexol-PM administered at 390 mg/m2 intravenously for 3 h     every 3 weeks was the maximum tolerable dose (MTD) in humans. Dose-limiting toxicities were     neuropathy, myalgia, and neutropenia. No hypersensitivity reactions were observed in any     patients despite the absence of antiallergic premedication. The recommended dosage for phase     II studies was 300 mg/m2.      Based on the promising results of taxane-based chemotherapy and the absence of standard     second-line chemotherapy regimen for advanced urothelial cancer, the investigators designed     phase II study to explore the efficacy and safety of Genexol-PM in advanced urothelial     patients, who previously treated with gemcitabine plus platinum as adjuvant chemotherapy or     1st line therapy for metastatic diseases.   "
141975|NCT01426113|"     The purpose of this study is to assess the safety and efficacy of a new formulation of     bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of     paediatric patients with glaucoma.   "
141976|NCT01426100|"     The aim of the present study is to evaluate the efficacy and safety of two dose combination     of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy     (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.   "
141977|NCT01426087|"     The main complications of cirrhosis are ascites, esophageal varices and hepatic     encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the     most common complication is ascites. Somatostatin is used to treat esophageal for a long     time, otherwise it could aslo prevent ascites. In the study, the investigators explore the     effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with     esophageal gastric varices.   "
142849|NCT01414699|"     The purpose of this study is to determine the extent to which manipulation of dietary variety     and course sequence affects fruit intake and overall energy intake in preschool-aged     children.   "
141978|NCT01426074|"     This study will determine the following: the response rate (including pathological CR rate),     TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX     bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in     Ktrans) after 1 cycle of bevacizumab therapy compared to baseline value in patients treated     with FOLFOX alone and those treated with bevacizumab at 5 mg/kg., the degree of hypoxis     (measured by tumor uptake of the 2-nitroimidazole EF5) induced by bevacizumab treatment and     its relationship to changes in tumor blood flow, and the degree of apoptosis (measured by     tumor uptake of di-annexin V) induced by bevacizumab treatment and its relationship to     changes in tumor blood flow.   "
141979|NCT01426061|"     There is a lack of scientific evidence that homeopathy and reflexology is effective treatment     of asthma. Systematic reviews have found that many clinical trials testing homeopathy and     reflexology have major flaws, such as small number of participants, lack of control groups or     inadequate allocation concealment.      The aim of the present study was to assess the effect of reflexology and individualised     homeopathy as an adjuvant treatment in asthma. In order to address this issue, the     investigators conducted an investigator-blinded, randomized, controlled parallel group study.   "
141980|NCT01426048|"     A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and     May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a     mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was     evaluated with condition-specific and general quality of life and health questionnaires.     Objective outcome was evaluated with gynaecological examination and a supine stress test.     Objective cure was defined as a negative stress test and no need for a reoperation for SUI     and subjective cure.   "
141981|NCT01426035|"     Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream     in the treatment of superficial varicose veins   "
142642|NCT01417403|"     This phase I trial studies the side effects and best dose of hydroxychloroquine in treating     patients with solid tumors undergoing radiation therapy for bone metastases. Drugs, such as     hydroxychloroquine, may make tumor cells more sensitive to radiation therapy   "
141982|NCT01426022|"     Rationale: Food choice is influenced by postprandial mood; the feelings of well-being after a     meal. Postprandial mood can be measured by subjective responses. Physiological responses may     play an important role in the generation of postprandial mood. However, the relationship     between subjective and physiological responses after a meal is not clear yet. To investigate     this relationship, moderate alcohol consumption will be used as a mood modulator, because of     its well-studied effects on mood. Postprandial mood depends on the current mood state.     Therefore the investigators will manipulate the current mood state by changing the ambiance     to measure the influence of moderate alcohol consumption with a meal on postprandial mood in     a pleasant or unpleasant ambiance.      Objective: To determine whether moderate alcohol consumption with a meal in different     ambiances affects postprandial mood, evaluated by subjective and physiological parameters.      Study design: Randomized, placebo-controlled, single-blind, cross-over trial      Study population: 28 apparently healthy, normal weight (BMI 18.5-27 kg/m2) women (18-45 y),     taking oral contraceptives.      Intervention: 4 times having dinner at TNO Zeist with either 3 glasses of sparkling white     wine (~30g alcohol) or alcohol-free sparkling white wine in either a pleasant or unpleasant     meal ambiance.      Hypothesis: It is hypothesized that moderate alcohol consumption with a meal in different     ambiances changes the response of subjective and physiological parameters of mood.        -  Ho: there is no effect of alcohol consumption and ambiance on mood        -  H1: there is an effect of alcohol consumption and ambiance on mood   "
141983|NCT01426009|"     The purpose of this study is to determine steady-state efficacy and dose response profile and     to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing     using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two     active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease     (COPD).   "
141984|NCT01425996|"     Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in     patient who is not suitable for transarterial chemoembolization (TACE) and other local     therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells.     Several previous studies have showed that local R/T is tolerable and can induce a substantial     tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy     of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study     aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and     radiotherapy in patients with locally advanced HCC and PVTT.   "
141985|NCT01425983|"     Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic     dysfunction, as well as alterations of the autonomic nervous system and the     hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between     inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia,     neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms,     sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary     intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT,     serotonin) increases sensitivity to stress.      It is therefore the investigators hypothesis that daily oral administration of an amino acid     mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease     neurovegetative disorders will target these neuroendocrine and metabolic alterations in     adults with psychosocial stress. The principal endpoints will be a decrease in points in the     psychological-neurological questionnaire (PNF).   "
141986|NCT01425970|"     Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and     placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment      Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189     with Ribavirin or INX-08189 with Daclatasvir or INX-08189 with Daclatasvir and Ribavirin   "
142004|NCT01425736|"     Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in     the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II     clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved     satisfactory therapeutic outcomes in patients with advanced squamous cell carcinoma of head     and neck, or glioblastoma. We therefore postulated that Nimotuzumab in combination with     conventional definitive chemotherapy might improve the rate of disease control (RDC),     progression-free survival (PFS),and overall survival in patients with recurrent and/or     metastatic SCCHN , which is a poor-prognosis patient population for whom there is currently     no standard treatment approach, we designed this trial to test this hypothesis.   "
141987|NCT01425957|"     THE STUDY WILL BE A TWO-PART RESEARCH      PART A and PART A extended:        1. To implement a common MRI acquisition protocol in multiple centers across Europe          (Pharma-COG partners).        2. Apply the common MRI protocol on phantoms and human subjects to characterize, compare          and minimize test-retest variability across the MR sites of WP5 for all the quantitative          metrics that will be later assessed on patients.      PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and     neurophysiological data in Mild Cognitive Impairment patient, we aim to:        1. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)          which is more sensitive than the changes observed in the loss of hippocampal volume          (primary endpoint) and correlate with the neuropsychological progression and conversion          (clinical secondary endpoints).        2. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)          at baseline which is more predictive of the loss of hippocampal volume (primary          endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI          patients.        3. To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe   "
141988|NCT01425944|"     This study has three aims that hope to expand the knowledge on the cause of Sturge-Weber     Syndrome (SWS) and improve clinical care of Sturge-Weber Syndrome patients.   "
142037|NCT01425307|"     The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy     (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell     anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently     receive chronic transfusions to reduce the risk of primary stroke. For the alternative     treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen     (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must     have a mean TCD velocity similar to that observed with transfusion prophylaxis.   "
141989|NCT01425931|"     O2C is a diagnostic device for non-invasive determination of oxygen supply in     microcirculation of blood perfused tissues. The optical sensor is easy to handle and     guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as     in research. The examinations are without any strain for your patient.      Determines by use of a glass fibre probe:      Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of     Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen     supply of organs and tissue.      With it is possible to measure locally the amount of oxygen which is transported into the     region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is     monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical     sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and     subsequently to organ failure, now can be detected in an early state by use of the new sensor     system.      One of these new developed sensors are used to place in rectal position during extracorporeal     circulation to determine the microcirculation.   "
141990|NCT01425918|"     Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD)     social deficits and studying the efficacy of this intervention, the investigators hope to     provide a means for children with ASD to more effectively and efficiently process social     information and enable them to more successfully engage in social interactions. Children     between the ages of 24 and 36 months and their families may join.   "
141991|NCT01425905|"     Background:      Type 2 diabetes is a chronic disease that puts individuals at risk for serious health     problems like heart disease, kidney failure, vision problems, and stroke. A major way that     type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin     (an important hormone in the body to keep blood sugar normal) isn t working as well as it     should, which can lead to problems with high blood sugar. Insulin resistance has been linked     to mood problems, stress, and depression, especially in women. To determine if group programs     can help reduce the risk for type 2 diabetes, researchers want to look at teenage girls who     are at risk for developing the disease.      Objectives:      To test whether a group program designed to improve mood also can help improve insulin     resistance in teenage girls who are at risk for developing type 2 diabetes, or whether a     group program that teaches healthy living skills is just as helpful.      Eligibility:      Teenage girls between 12 and 17 years of age who are at risk for developing type 2 diabetes.      Design:        -  Participants will have two screening visits to find out if they are eligible to take          part in the study. The first visit takes about 3 hours and will involve a physical exam,          medical history, questionnaires and an interview about mood problems and possible          depression. The second visit takes about 6 hours and will involve a full body scan to          measure muscle and fat, blood draws and a glucose test to determine insulin resistance,          questionnaires about general well-being and eating habits, eating meals and snacks, and          an exercise test.        -  Participants will join one of two group programs at the National Institutes of Health.          One group focuses on learning skills to help with bad moods and stress. The other group          covers topics that are important for teens to lead a healthy life. The groups will meet          for 1 hour once a week for 6 weeks during after-school hours.        -  At the end of the groups, participants will have three follow-up visits. The first visit          will be 6 weeks later, the second will be 6 months after the start of the group program,          and the third will be 1 year after the start of the group program. Each visit will take          about 6 hours. These visits are similar to the second screening visit before the groups.        -  Some participants will have extra tests to study stress at the second screening visit          and the 6-week, 6-month, and 12-month follow-up visits. Participants will give samples          of DNA, saliva to measure stress hormones, and they will take part in a brief stress          test.      For more information, visit the study website at: http://mir.nichd.nih.gov or contact the     research coordinators for the study at 301-594-3198.   "
141992|NCT01425892|"     Background:      -Sjogren s syndrome is a disease that affects about 1-4 million Americans. It is more common     in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and     dry mouth. The cause of Sjogren s syndrome is unknown, but inflammation plays an important     role. The purpose of this study is to learn more about Sjogren s syndrome.      Objectives:      -To better understand how Sjogren s syndrome begins and how it affects patients so that we     can develop better ways to treat them.      Eligibility:        -  Participants must be 16 years of age or older.        -  They must have a diagnosis of Sjogren s syndrome or have at least two symptoms of          Sjogren s syndrome.      Design:        -  People taking part in the study will come to the NIH Clinical Center for at least three          visits.        -  During these visits, participants will have a medical history and physical exam. They          will have oral and dental assessments, and saliva collection. Lab tests (blood and          urine) and dry eye exams will be done. Participants will answer questionnaires and have          salivary scintigraphy (adults only unless required for diagnosis).        -  Other optional tests may also be done. Participants may have to come in for additional          visits if they have these optional tests or if their disease changes.        -  The only treatment provided as part of this study is for medical emergencies or          complications that occur while you are at NIH for evaluation.   "
141993|NCT01425879|"     This phase II trial is studying how well MD2206 works in treating patients with advanced     refractory biliary cancer that cannot be removed by surgery.   "
142005|NCT01425723|"     The primary objective of the study is to evaluate the long-term safety of rFIXFc in     participants with hemophillia B.      The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention     and treatment of bleeding episodes.   "
142006|NCT01425710|"     Non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR),     corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during     laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative     changes in volume status and to estimate the volume depletion.   "
142007|NCT01425697|"     The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site     infections in patients having elective cardiac surgery.   "
142019|NCT01425541|"     Girls with high levels of the male hormone testosterone often develop polycystic ovary     syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess     facial and body hair, and weight gain. Women with PCOS also have difficulty becoming     pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as     they grow up. Most girls continue to have high levels of male hormone as adults. In addition,     girls with elevated levels of male hormones often have lower fertility rates in adulthood. In     this study the investigators will aim to discover the effect of 7 days of estrogen and     progesterone on GnRH pulses in girls and women with the goal of understanding how and why     some girls and women have higher levels of male hormone and the causes of PCOS. If     investigators understand the causes of these disorders, they may be able to better treat them     and perhaps even learn how to prevent the development of PCOS.   "
142050|NCT01425138|"     This project involved a systematic literature review of published trials of treatments for     moderate-to-severe plaque psoriasis. Data was extracted from the publications on various     psoriasis endpoints including the Physician Global Assessment (PGA), Dermatology Life Quality     Index (DLQI), and Short-Form 36 (SF-36). A traditional meta-analysis and a mixed treatment     comparison was conducted on the extracted data.   "
141994|NCT01425866|"     Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical     trials have clearly demonstrated that a better control of blood glucose level and of other     risk factors is efficient in preventing or retarding the complications of the disease. On     Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high     level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured     group self-management education maintained at the community level for 2 years in patients     with insufficiently controlled type 2 diabetes has better metabolic results (as attested by     improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months)     self-management program, based on the same theoretical basis and framework (learning nests     empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus     with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2     intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long     sessions depending on individual assessment), or a long term program including the same     initial program as 1st arm, but with group self management education sessions, maintained for     2 years (4-monthly assessment, empowerment, and contextual action planning; facultative     additional specific thematic sessions being delivered if needed). Medical visits will be held     quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics,     tobacco consumption, diabetes complications) and yearly for blood glucose, lipids,     micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires),     treatment recording, quality of life, self-efficacy, anxiety and depression scales, and     social support.   "
141995|NCT01425853|"     The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS)     and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of     patients with moderate to severe knee osteoarthritis (OA).   "
141996|NCT01425840|"     This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated     lidocaine on oral mucosa.   "
141997|NCT01425827|"     Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis     worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options     have had limited symptomatic effect and are associated with significant side effects.     Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to     have, besides its antidepressant properties, a centrally acting analgesic effect.      The aim of the present study was to investigate the efficacy of duloxetine in reducing pain     in older adults with knee OA.      288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary     knee OA attending the outpatient clinic of our institution were enrolled in this study. All     patients underwent a physical examination and where questioned about the number of flares.     Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid     obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of     duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The     primary outcome measure was pain reduction. Secondary outcome measures included improvements     in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and     Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported     physical function as measured with the Western Ontario and McMaster Universities     Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression     Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded.     Safety and tolerability were also assessed. Data was collected at baseline and at monthly     intervals for 4 months. All staff involved in data collection was blinded to the treatment     assignment groups.   "
141998|NCT01425814|"     The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single     doses of inhaled LAS100977 in COPD patients.   "
141999|NCT01425801|"     The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled     LAS100977 QD in patients with persistent asthma.   "
142000|NCT01425788|"     The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used     with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current     practice.   "
142001|NCT01425775|"     Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease.     Vitamin D has potent immunomodulatory properties that have promoted its potential use in the     treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE     patients and determined alterations in inflammatory, hemostatic markers as well as disease     activity before and after vitamin D supplementation.      248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were     randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months.     Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18,     TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12     months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were     measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were     classified as vitamin D insufficiency, and levels < 10 ng/ml as vitamin D deficiency.The mean     25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.   "
142002|NCT01425762|"     This is a randomized controlled study that will place patients into a choice and a no     choice group. The choice group will be able to choose between receiving 100 mcg or 200 mcg     intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or 200     mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured at 3,     6, 12, 24, and 36 hours.   "
142003|NCT01425749|"     The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined     with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer     Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites,     intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data on     the immunological response to ASCI in the injection site microenvironment, in the node     draining the vaccine site (sentinel immunized node) and in the blood and whether there are     large differences in the magnitude, persistence, or type of immune response induced as a     function of the ASCI injection. Evaluation of immune responses to the ASCI will include,     amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.   "
142010|NCT01425658|"     Objective :To compare the analgesic effect of intrathecal clonidine and fentanyl as an     additive to bupivacaine in patients undergoing cesarean section .      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients     18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal     anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were     randomly allocated to one of three groups of 30 each. The clonidine group (groupC) received     bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group     (group F) received bupivacaine 10mg combined with25microgram fentanyl and the placebo group     (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time     to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level     , onset of motor block, duration of blockade, hemodynamics variables, the incidence of     hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen     (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,     dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were     instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain,     10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient     requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for     post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of     administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.   "
142011|NCT01425645|"     No evidence-based, evaluated, population-appropriate resources exist to translate Type 2     diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such     large-scale interventions include:        -  the need to identify, then target specific at-risk populations        -  significant time-delays before any program effects on T2DM incidence may manifest.      However, women with gestational diabetes (GDM) are a readily identifiable study cohort at     significant risk for recurrent GDM and T2DM—hence GDM women provide important opportunities     for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD     (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting     women with recent GDM in the context of their families.      FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with     recent GDM, within their family context. Five Canadian sites and 177 women will participate.     Multifaceted information and behavioural change support will be provided for diet, weight     loss, and activity through: seminar, walking groups, electronic updates, password-protected     social networking site.      Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices;     HbA1C; body habitus at study onset/during study/12 months/24 months.      Consenting immediate family members will have protective knowledge/diet/exercise choices/body     habitus measures documented at study onset/12 and 24 months.   "
142012|NCT01425632|"     The objectives of this study are: to confirm the superiority of TAU-284 over placebo after     two weeks of administration to pediatric patients with perennial allergic rhinitis, and to     investigate the dose response, safety, and plasma concentrations of TAU-284.   "
142013|NCT01425619|"     Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing     this procedure. The investigators intend to examine if medical clowns compared with local     anesthetic cream can decrease these feelings in children.   "
142014|NCT01425606|"     Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by     using the stewart approach to acid - base interpretation, would like to show that the     positive charged m- proteins produced in m.m.result in true hyponatremia.   "
142015|NCT01425593|"     Chronic idiopathic urticaria (CIU) is a common form of chronic urticaria in which the cause     is not detected after intensive clinical and laboratory investigation.In view of the current     data, it was suggested that at least part of the patients with CIU have an autoimmune     process.This study is designed to investigate the mechanisms involved in the regulation and     activation of the immune cells in patients with CIU and corelate them with disease activity   "
142016|NCT01425580|"     Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin with insulinotropic     properties. Apart from the glycemic actions, cardiovascular effects by GLP-1 have recently     been reviewed. Receptors for GLP-1 are expressed in the rodent and human heart and acute     activation of GLP-1 signalling has been shown to influence e.g. heart rate and blood     pressure. In a knock-out mouse model, GLP-1R-/- mice exhibited a defective cardiovascular     contractile response together with left ventricular hypertrophy. GLP-1 improves severe left     ventricular heart failure in humans suffering from a myocardial infarction. Hence, it has     been demonstrated that GLP-1 exerts direct functional effects through both GLP-1 receptor     dependent and independent pathways in the heart.      Native GLP-1 is an extremely short acting peptide, with a half-time breakdown of 1-2 minutes,     a feature that makes it unsuitable as a drug treatment for type 2 diabetes. To this end,     several long-acting GLP-1 analogues, drugs for treating type 2 diabetes, have been tested for     this purpose. The analogue liraglutide exerts its effects via the native GLP-1 receptor,     localized not only on the pancreatic β-cells, but also in the human heart. Interestingly,     liraglutide has been demonstrated to have beneficial effect on heart function in mice. Taken     together, recent data shows that GLP-1 and its stable analogue liraglutide exert beneficial     cardiovascular effects.      The purpose of this study is to determine whether the glucagon-like peptide-1 (GLP-1)     analogue liraglutide improves heart function (measured as left ventricle longitudinal     function and/or functional reserve during rest and/or after exercise) after 18 weeks of     liraglutide + metformin, compared with glimepiride + metformin, using tissue Doppler     echocardiography.   "
142017|NCT01425567|"     If a child is unable to tolerate enough of his/her feeding orally to grow and requires that     nutrition is given by vein (IV parenteral nutrition), it can result in severe liver disease.     This is called cholestasis. IV fat that children receive may be contributing to this liver     disease. A different fat mixture comprised from fish oil could be used in place of     intralipid. This is a compassionate use of the fish oil and not a comparison of the two. We     believe the use of fish oil may provide less liver disease and decrease the need of liver     transplant or dying than those who receive the usual fat.   "
142018|NCT01425554|"     This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography     and air-plethysmography for the assessment of abnormalities in the internal jugular veins,     with catheter venography as the reference test.   "
142020|NCT01425528|"     The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of     tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH)     deficiency and to asses the potential impact of oral Kuvan on mood and function in     individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression,     fatigue, trouble concentrating, or memory loss. This will be a phase one study. The     investigators will monitor patients over a period of three to six months while on the     medication. Medication levels will be monitored by measuring the BH4 levels in cerebral     spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up lumbar     punctures for this purpose. The investigators will also monitor emotional function and motor     function.   "
142021|NCT01425515|"     The investigators are conducting a single group intervention study to improve blood pressure     control and reduce racial and literacy related disparities among people with hypertension.     The intervention includes providing patients with home blood pressure monitors, administering     phone-coaching to participants, and improving hypertension care at the participating     practices from which patients are enrolled. The investigators will follow the patients for 2     years to determine if blood pressure control improves. In addition, the project will explore     genetic factors associated with cardiovascular disease risk and treatment success.   "
142022|NCT01425502|"     A cluster randomised controlled trial to test the effectiveness of an informatics tool,     educational and financial incentives to reduce high risk prescribing of non-steroidal     anti-inflammatory drugs and anti-platelet agents.   "
142023|NCT01425489|"     Development of a new MS-based biomarker for the early and sensitive diagnosis of Krabbe     Disease from plasma   "
142024|NCT01425476|"     This is a biomarker study with the goal of measuring changes in proteins and gene     methylation. This study is not intended for use in diagnosing, mitigating, treating, curing,     or preventing disease.      The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in     combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), to     decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of     breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.   "
142025|NCT01425463|"     To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate     Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron     Deficiency Anemia.   "
142026|NCT01425450|"     The study aims to:        -  study the safety of the drug (HF1020) in healthy male adults        -  study how well the study drug (HF1020) is tolerated in healthy male adults        -  find the maximum dose that is tolerated in healthy male adults   "
142027|NCT01425437|"     Much progress in treatment of various tumors has been made in the laboratory and the results     have been brought back to the patients, i.e. from bench to bedside. This trial intends to     collect samples of keloid tissue from patients and study them in laboratory. Such a research     may help us with finding better treatments for keloid.   "
142028|NCT01425424|"     This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest     elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension)     or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D.     This may reduce the chances of developing diabetes or high blood pressure or both later in     life.   "
142029|NCT01425411|"     The study hypothesis: Valsartan as an angiotensin II receptor blocker treatment has     beneficial effects on both midwall mechanics and myocardial functions in hypertensive     patients with Left ventricular hypertrophy.   "
142030|NCT01425398|"     High-dose statin therapy around the time of surgery, decreases inflammation in patients     undergoing cardiac valve surgery, and thereby improves clinical outcomes.   "
142031|NCT01425385|"     Patients with liver failure undergoing liver transplantation often have clinical or     sub-clinical encephalopathy that may lead to increased intracranial pressure. The latter may     lead to abnormal regulation of blood flow to the brain (cerebral autoregulation) complicating     patient management during and after general anesthesia. The current methods for monitoring     for elevated intracranial pressure are invasive and, thus, limited to severe encephalopathy.     In this study the investigators will evaluate the potential utility of monitoring cerebral     blood flow (CBF) autoregulation non-invasively using near infra-red spectroscopy in patients     undergoing liver transplantation.   "
142032|NCT01425372|"     Streptococcus pneumoniae is a major cause of serious bacterial infections, particularly among     young children. Over 30 different types of the pneumococcus germ can cause invasive disease,     but 7 types (namely serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) are responsible for around 75%     of cases in young children. A pneumococcal conjugate vaccine against these 7 serotypes (PCV7;     Prevenar ®, Wyeth Vaccines) was introduced into the UK national immunisation programme in     September 2006 and has resulted in a rapid reduction in pneumococcal disease caused by the 7     serotypes among both vaccinated children and older unvaccinated children and adults through     herd immunity. By 2009, over half of all invasive pneumococcal cases in young children were     caused by six other pneumococcal serotypes (1, 3, 5, 6A, 7F and 19A) that are included in a     newly licensed 13 valent pneumococcal vaccine (PCV13; Prevenar 13®, Wyeth Vaccines). In April     2010, PCV13 replaced PCV7 in the UK immunisation programme with the aim of further reducing     cases of invasive pneumococcal disease. The antibody responses induced by the 7 serotypes in     both PCV13 and PCV7 have been shown to be comparable, but the protection offered by the     additional 6 serotypes in PCV13 merits further study. Also, it is possible that the use of     PCV13 instead of PCV7 may interfere with immune responses to other vaccines, such as     Haemophilus influenzae serotype b (Hib), which are given to infants at the same time as     PCV13. The proposed study will aim to collect one blood sample from infants after they     receive their routine vaccinations at 2, 3 and 4 months in order to their measure immune     responses to routine vaccines. The investigators hope that their results will help us better     understand the added protection offered by the 13valent pneumococcal vaccine and ensure that     children are adequately protected by the other vaccines they receive.   "
142033|NCT01425359|"     This study will evaluate the effect of ranolazine compared to placebo on the average weekly     angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who     have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the     frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to     record their daily angina episodes in a diary at the end of each study day. Ranolazine is     approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.   "
142034|NCT01425346|"     The goal of this study is to measure lens fluorescence in normal subjects at various     chronological ages that could serves as a guide to clinicians in determining changes in eye     health. A measure of lens fluorescence can be used by clinicians as an indication of     degenerative changes occurring in the lens of the eye.   "
142038|NCT01425294|"     This study is a post-authorisation pharmacoepidemiology study, committed to Center for Drug     Evaluation (CDE) and State Food and Drug Administration (SFDA), in order to provide more     efficacy and safety data about Faslodex 250mg in real life clinical practice in China. The     objective of the post marketing study is to explore the efficacy and tolerability of     Fulvestrant (FASLODEX™)250 mg in postmenopausal women with oestrogen receptor positive,     locally advanced or metastatic breast cancer for disease relapse on or after adjuvant     anti-estrogen therapy or disease progression on therapy with an anti-estrogen.   "
142039|NCT01425281|"     Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center     clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular     Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary     Stent System (XIENCE)   "
142040|NCT01425268|"     This study is designed to compare the performance and safety of the AirXpander tissue     expander to standard saline expanders in patients undergoing two-stage breast reconstruction     following mastectomy.   "
142041|NCT01425255|"     The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake     patterns in parents of children with type 1 diabetes (T1D) before and several weeks after     initiating using real-time continuous glucose monitoring (RT-CGM) of their children.   "
142042|NCT01425242|"     Inflammation of the blood vessel plays an important role in the development and growth of a     dilated abdominal aorta. An elevated blood pressure leads to an increase in inflammation,     therefore blood pressure lowering is an important part of the treatment of patients with a     dilated abdominal aorta who also have an elevated blood pressure. In the investigators study     the investigators compare the anti-inflammatory effects of 2 different blood pressure     lowering strategies. The investigators hypothesize that both strategies will decrease     inflammation, however the investigators believe the total decrease of inflammation depends on     the type of blood pressure lowering medication used.   "
142043|NCT01425229|"     The aim of the present study is to assess the impact of the OATP1B1 genotype (SLCO1B1*15 vs.     wild type; ~2% SLCO1B1*15 haplotypes in Caucasian population) and the CYP2C9 genotype (*2 and     *3 allele vs. wild type; ~5% poor metabolisers in Caucasian population) on the     pharmacokinetics of bosentan and the impact of CYP3A4-inhibition by clarithromycin on steady     state bosentan which is a CYP3A4 inducer itself.      This study will focus on differential effects of genotypes and co-medication on the     pharmacokinetics of bosentan at the metabolic and transport level. Participants will be     genotyped for CYP2C9 (inclusion criterion), OATP1B1 (inclusion criterion), and CYP3A5 (no     inclusion criterion).   "
142044|NCT01425216|"     Treatment of keloid disorder is an area of unmet medical need. Current treatments for keloid     partially address small and localized keloids, yet there are no wholly satisfactory or     effective treatments for patients with extensive keloids. Such patients may benefit from     effective systemic treatments.      Sorafenib has the potential to regulate the three known dysregulated biological pathways in     keloid tissue.   "
142045|NCT01425203|"     The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in     combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective     in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The     primary hypothesis is that the percentage of participants achieving sustained virologic     response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.   "
142046|NCT01425190|"     This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir     following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric     participants.   "
142078|NCT01424774|"     This study will be performed at clinical sites that have administered CardioGen-82® to     patients from January to July 2011. The patients enrolled(i.e., target date patients) will     be all those who were dosed at the end of use of the CardioGen-82® generators on the last day     of generator use from the generator that was used immediately prior to the recalled generator     (i.e., target date generators). These are not patients who received drug eluted from the     recalled generator. Of these patients, it is planned that 100 patients will be entered in     this trial.   "
143983|NCT01399775|"     1. Evaluation of dimensional changes in alveolar ridge following immediate implantation          compared to delayed implantation        2. evaluation of the effect of gap dimensions between socket walls and dental implant in          implant stability   "
142047|NCT01425177|"     In recent years, endoscopic sphincterotomy and stone extraction are standard procedures for     the removal of bile duct stones.      After procedures, there are some complications such as stone recurrence, papillary stenosis,     cholangitis and liver abscess. These recurrent symptomatic bile duct stones, despite     increasing experience and success with the procedure, occur in 4% to 24% of patients.      Gallbladder stone, pneumobilia and many other various factors are known to be associated with     CBD stone recurrence. Lithotripsy was also related to the development of recurrent stones. It     is natural that small stone fragments left after lithotripsy may act as nidi for stone     recurrence.      Small remaining stone could not be completely detected only using ERCP stone removal and     remaining stone removal can reduce residual and recurrent stones. Saline irrigation was     effective immediately after ERCP stone removal to remove remaining small stones.      Saline irrigation has many advantages such as easy to treatment during ERCP stone removal,     almost no additional cost and rare side effect. This study The authors expect this study is a     remarkable role of ERCP stone removal procedure.   "
142048|NCT01425164|"     In hemodialysed patients, coronary heart disease is the leading cause of mortality and     morbidity. Most of the commonly used drug for ischemia are used in this patients, but few     prospective data are available. Among anti-ischemic drugs betablocker provided evidence of     beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used     also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of     benefit in general population, but no study is available in dialysis patients. Aim of the     present study is to compare in a randomized, double-blind, parallel group trial the effects     of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed     population of patients with established coronary heart disease.   "
142049|NCT01425151|"     In the following randomized, crossover study, the investigators test the hypothesis that ease     of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM     in anesthetized pediatric patients.   "
142051|NCT01425125|"     Hyponatremia, defined as a serum sodium < 135 mmol/l, in patients without edema has undergone     significant changes where it is now evident that even mild hyponatremia should be treated     because of its association with symptoms, especially a fourfold increase in falls over the     age of 65 years. There is an unresolved controversy over the relative prevalence of the     syndrome of inappropriate secretion of antidiuretic hormone (SIADH) and cerebral/renal salt     wasting (C/RSW). Resolution of this diagnostic dilemma becomes urgent because of divergent     therapeutic goals, to water-restrict in SIADH or to give salt and water supplementation in     C/RSW. The dilemma is compounded by recent reports of C/RSW occurring in patients without     cerebral disease, thus adding further confusion in defining the relative prevalence of both     syndromes. Because of overlapping laboratory and clinical findings in both syndromes, only     differences in the state of extracellular volume differentiates one syndrome from the other,     being high normal to increased in SIADH and decreased in C/RSW. The investigators have used     fractional excretion (FE) of urate to categorize patients with hyponatremia. The increased     FEurate that is observed in hyponatremic patients with SIADH and C/RSW can be used to     differentiate both syndromes by correcting the hyponatremia and determining whether FEurate     normalizes as in SIADH or remains increased in C/RSW. The present studies have been designed     to determine total body water by deuterium and extracellular water by sodium bromide in     patients with nonedematous hyponatremia with normal and increased FEurate to differentiate     more conclusively whether the patient has normal or decreased water volumes. The     investigators will also correct serum sodium rapidly with judicious administration of     hypertonic saline over approximately three days and determine whether FEurate normalizes as     in SIADH or remains increased as in C/RSW. In another group of patients, The investigators     have data to suggest that those with normal sodium and increased FEurate is consistent with     C/RSW. The investigators intend to do the same water volume studies to determine whether an     increased FEurate with normonatremia would have decreased total and extracellular water that     these patients have C/RSW without the need to correct a prior hyponatremia.   "
142052|NCT01425112|"     Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known     to reduce neovascularization and fibrovascular proliferation in inflammatory conditions,     including post-operative inflammation. It has shown efficacy in numerous ocular     conditions(off-label), that includes Age related macular degeneration, proliferative diabetic     retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an     option for preventing recurrence of pterygium and as an adjunct to improving outcomes of     trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration     for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab     with topical therapy over one month in terms of outcomes of trabeculectomy surgery,     non-progression of field loss and stable intraocular pressure(IOP) control.   "
142053|NCT01425099|"     Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical     development for the treatment of human immunodeficiency virus (HIV) infection. DTG is     primarily metabolized by UDP-glucuronosyltransferase (UGT1A1) with cytochrome P450 (CYP)3A4     pathway as a minor route. Corticosteroids have demonstrated induction effects on UGTs and     CYP3A4. Corticosteroids are often used in HIV-infected subjects and have the potential to     reduce DTG exposure due to enzyme induction when co-administered. The primary objective of     this study is to determine whether concomitant prednisone administration can affect the     pharmacokinetics (PK) of DTG.      The study is a two part, two period, open label study. Part 1 will evaluate the effect of a     high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the     results from Part 1. In Part 1, approximately 12 healthy subjects will receive DTG 50mg q24h     for 5 days in Period 1. Subjects will then be administered DTG 50mg q24h in combination with     prednisone 60mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period 2.     PK data of DTG will be obtained from Part 1 and used to inform decision making on the need     for Part 2. If DTG exposure is reduced by more than 50% in Part 1, Part 2 will be carried out     where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in Period 1     followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed by a 5 day     taper (total duration of 10 days) in Period 2. Safety evaluations and serial PK samples for     DTG will be collected during each treatment period. A follow-up visit will occur 7-14 days     after the last dose of study drug. All doses of study drugs will be taken following a     moderate fat meal. This study will be conducted at one center in the United States, with     healthy adult male and female subjects.   "
142054|NCT01425086|"     The purpose of this pilot study is to evaluate the performance of a new warming technology     (Embrace Isothermal Mattress) during the thermal weaning of premature infants from incubators     to open cribs. The investigators aim to study the Embrace Isothermal Mattress over a 24-hour     period before the infant is transitioned out of the incubator.   "
142099|NCT01424501|"     This study will assess the safety and immunogenicity of GSK Biologicals' investigational     tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months     to human immunodeficiency virus (HIV) negative adults who have received treatment for TB     disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease     (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB     disease (denoted TB-naïve cohort) will also be enrolled.   "
142055|NCT01425073|"     Both antiretroviral therapy (ART) and prevention of opportunistic infections (OIs) have been     associated with significantly decreased mortality in HIV-infected individuals.     Trimethoprim-sulfamethoxazole (TMP/SMZ), also known as bactrim, is a common antibiotic and     used as prophylaxis for OIs. For countries with high prevalence of HIV and limited health     infrastructure, the WHO endorses universal TMP/SMZ for all HIV-infected individuals. Notably,     these guidelines were created prior to the scale-up of ARTs. Following ART and subsequent     immune recovery, TMP/SMZ may no longer be required. In the US and Europe, for example,     TMP/SMZ is discontinued after patients show evidence of immune recovery. Therefore, we     propose a prospective randomized trial among HIV infected individuals on ART with evidence of     immune recovery (ART for > 18mo and CD4 >350 cells/mm3) to determine whether continued     TMP/SMZ prophylaxis confers benefits in decreasing morbidity (malaria, pneumonia, diarrhea),     mortality, CD4 count maintenance, ART treatment failure and malaria immune responses.   "
142056|NCT01425060|"     Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was     unintended and the majority of non-pregnant opioid-maintained women do not use contraception     or use less effective methods like condoms. This proposal aims to develop and test a novel     contraceptive management program to increase use of more effective contraceptives among     opioid-maintained women and to examine the impact of more effective contraceptive use on     condom use. The proposed research may reduce unintended pregnancy among opioid-dependent     women without increasing their risk of sexually transmitted infections and the knowledge     gained will also have implications for addressing high rates of unintended pregnancy in the     general population.   "
142057|NCT01425047|"     Mangosteen is a tropical tree. The peel of mangosteen fruit is used in traditional medicine.     The purpose of this study was to determine the bioavailability of the xanthones from     mangosteen juice in adult human subjects.   "
142066|NCT01424930|"     The purpose of this study is to establish the safety profile of oral (by mouth) abiraterone     acetate and oral prednisone following short-term administration after standardized low-fat or     high-fat meals to patients with metastatic (spreading) castration-resistant prostate cancer     (mCRPC).   "
142081|NCT01424735|"     Although idiopathic steroid resistant optic neuritis is very uncommon, there is no     established treatment protocol for such patients. Toll like receptors (TLRs) especially TLR-9     has been shown to play a role in the pathogenesis of optic neuritis. This small case series     aims to determine whether immunomodulators directed specifically at TLR-9(i.e. TLR-9     antagonism)play any role in improving the visual function in such patients.   "
142058|NCT01425034|"     Carpometacarpal (CMC) arthritis of the thumb joint ('basal arthritis') is a common entity     treated by hand surgeons in our society. It can be a significant source of functional     disability secondary to a painful, and often weak, grip. Once patients have failed treatment     by conservative means, such as splinting, anti-inflammatories, and cortisone injections, the     next option is surgical management. Several surgical options are available depending on the     severity of the disease. For the early stages of arthritis options include a ligament     reconstruction or a metacarpal extension osteotomy. For advanced stages, only salvage     procedures exist. These have included simple trapeziectomy, arthrodesis and implant     arthroplasty. The most common procedure, however, has been a trapeziectomy with a ligament     reconstruction tendon interposition   "
142059|NCT01425021|"     The goal of this is to improve durability of total joint replacements in patients, thereby     improving clinical outcomes and implant performance. To reach this objective, our research     program would like to assess the safety, efficacy, performance, and durability of FDA     approved biomaterial and implant designs used in joint replacements.   "
142060|NCT01425008|"     This is a phase 1, multicenter, nonrandomized, open-label, dose escalation study. The study     will be conducted in 2 stages, Dose Escalation and Dose Expansion. The Dose Escalation phase     will include patients with solid tumors (including melanoma) who have failed or are not     candidates for standard therapies or for whom no approved therapy is available. The Dose     Expansion phase will include patients with metastatic melanoma.   "
142061|NCT01424995|"     This will be a prospective study of all children ages 0 - 5 years old at the time of entry     into the study that meet the inclusion criteria who present with congenital trigger thumb.     Patient records will be reviewed for eligibility before obtaining parental permission. They     will be enrolled in the study at their first visit and followed every year for up to 4 years     or until one of the exclusion criteria are met. Participating sites include the University of     Utah Orthopaedic Center, Primary Children's Medical Center and Shriners Hospital for     Children.   "
142062|NCT01424982|"     The goal of this clinical research study is to learn if intensive chemotherapy combined with     ponatinib, followed by maintenance therapy, can help to control ALL with the Ph chromosome     and/or BCR-ABL. The safety of this treatment will also be studied.      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or     death. A blood clot may occur within 2 weeks after you start taking the drug. About 25% (1 in     4) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that     do not have other known risk factors for forming clots. If you develop a blood clot, you will     need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the     clot and restore blood flow.   "
142063|NCT01424969|"     The purpose of this study was to determine the effect of platelet-rich fibrin matrix (PRFM)     augmentation to at-risk arthroscopic rotator cuff repairs on healing rates and functional     outcome scores. The investigators performed an observational cohort study in which a     consecutive series of patients with rotator cuff tears at risk for retear was prospectively     evaluated after arthroscopic repair augmented with PRFM. Clinical and magnetic resonance     imaging (MRI) outcomes of the PRFM-augmented repairs were compared with historical controls     with similar at-risk tears without PRFM augmentation.   "
142073|NCT01424839|"     STUDY DESIGN:      Prospective, non-randomised multicentre study with patients stratified according to risk     groups INVESTIGATIONAL MEDICINAL PRODUCTS The IMPs on this trial are Carboplatin, Cisplatin,     Ifosfamide and Etoposide (as approved by German competent authority).      PRIMARY OBJECTIVES:      Germinoma        -  To maintain current high event-free survival (EFS) rates using a risk adapted approach        -  In localised germinoma: to omit whole brain and spinal irradiation by using combined          treatment with standard chemotherapy and ventricular irradiation (+/- boosts)        -  In bifocal tumours (pineal + suprasellar): to treat as non-metastatic disease and to          omit whole brain and spinal irradiation by using combined treatment with standard          chemotherapy and ventricular irradiation (+/- boosts)        -  In metastatic disease: to maintain current excellent EFS in metastatic germinoma with          craniospinal irradiation Malignant non-germinoma      To improve EFS:        -  by dose escalation of chemotherapy in patients identified as high risk at diagnosis (          age < 6 years and/or AFP serum / CSF > 1000 ng/ml)        -  by standardising the surgical approach for residual disease after treatment Teratoma        -  To register patients and collect data regarding diagnostics, treatment and outcome in          order to develop future treatment strategies      SECONDARY OBJECTIVES:      Germinoma        -  To minimise long term effects of irradiation by sparing spinal and whole brain          radiotherapy in non-metastatic disease Malignant non-germinoma        -  In standard risk to maintain EFS with chemotherapy and local irradiation Teratoma        -  To evaluate the influence of surgery and treatment on outcome to assist in the          development of a fu-ture treatment strategy For all histological subtypes        -  To improve accuracy of diagnosis and staging in all registered patients        -  To standardise neurosurgical intervention        -  For all patients requiring biopsy or resection according to protocol guidelines, to          collect and to store tumour material, and CSF where possible, for use in future          biological studies.      ENDPOINTS / Criteria for evaluation:      Main end point      Event-free survival, defined as minimum time from the date of diagnosis to:        -  Death from any cause        -  Relapse        -  Progressive disease on therapy        -  Or second malignancy      Secondary end points        -  Overall survival, defined as time to death from any cause, measured from the date of          diagnosis        -  Short and long term toxicity.   "
142064|NCT01424956|"     To determine the impact on Interpreting Physician performance in detecting breast cancer, as     defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated     Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening     mammography alone in asymptomatic women with >50% parenchymal density and a screening     mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign     findings).      The effect of the improved Reader performance is illustrated by plotting the ROC curves for     XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM,     the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under     the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null     and alternative hypotheses can be formally expressed as follows:      H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance     will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS     Assessment Category of 1 or 2.      HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader     performance will be changed with the addition of ABUS to a screening mammogram assigned a     BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered     equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS     is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05     for a two-sided test.   "
142065|NCT01424943|"     The purpose of the project is to assess the initial efficacy of Stepping Stones Triple     P-Positive Parenting Program (SSTP) with parents of children below age two with developmental     disabilities to strengthen families and prevent child maltreatment.   "
142067|NCT01424917|"     Post transplant vasculopathy is a major negative outcome in heart transplantation. Current     methods of detection are highly invasive and pose a risk to transplant recipients.     Noninvasive markers of endothelial function can be used to detect transplant vasculopathy.     Endothelial biomarkers such as: endothelial nitric oxide synthase, vascular cellular adhesion     molecules, intracellular adhesion molecules, endothelin-1, thromboplastin, circulating     endothelial cells, uric acid, and C-reactive play a role in the pathophysiologic mechanism of     vasculopathy. Therefore, the investigators would like to assess the association between     various endothelial biomarkers and the presence or absence of transplant vasculopathy.   "
142068|NCT01424904|"     The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40‐km     time trial in trained male cyclists. The investigators believe that DGB-01 will improve     performance on the time trial as measured by a reduction in the amount of time required to     complete the distance, using a computerized cycle ergometer.   "
142069|NCT01424891|"     Lowering LDL cholesterol by statins has been proven to be associated with reduction of     proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the     effects of newer cholesterol lowering agents such as ezetemibe with respect to their     anti-inflammatory potential are less intensively studied. Therefore the investigators     analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination     with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear     cells (PBMCs) of patients with type 2 diabetes.   "
142070|NCT01424878|"     Background:      Medullary thyroid carcinoma (MTC) is a rare malignancy, occurring either as a sporadic     disease (75% of cases), or in a hereditary pattern as multiple endocrine neoplasia (MEN) type     2 (MEN2A or MEN2B) or familial medullary thyroid carcinoma (FMTC). The MTC arises from the     neural crest C-cells and in hereditary cases the first pathological disorder is C-cell     hyperplasia (CCH) Most patients with MTC have advanced disease at the time of diagnosis.      Chemotherapy and external beam radiotherapy have been minimally effective. Molecular targeted     therapeutics (MTTs) and other receptor kinases in patients with advanced MTC have     demonstrated activity.      Despite some clinical responses, the collection of tumor tissues and autologous normal     tissues has been virtually non-existent. Thus, laboratory studies defining affected molecular     targets and downstream pathways, and molecular data providing direction for future clinical     trials has yet to occur.      Data from molecular studies of tumor tissue of hereditary or sporadic MTC patients will     assist in predicting clinical behavior and the biology of MTC in predicting response to a     given MTT, and in designing combination clinical trials.      Objectives:      Clarify how normal molecular pathways are altered by mutations in the RET protooncogene.     Including additional genetic mutations and unidentified chromosomal translocations.      Correlate results from molecular analyses of MTC tissue with patient s clinical course.      Define how the molecular and clinical data will be useful in designing targeted therapy for     patients with MTC.      Eligibility:      Patients must have confirmed diagnosis of C-cell hyperplasia, primary MTC, or metastatic MTC     with archived pathology specimens available at Washington University.      Design:      Paraffin blocks of MTC tissues from archival samples at Washington University Department of     Pathology will be selected.      H&E slide from selected tissue blocks will be examined for molecular study suitability.      Necessary tissue samples from blocks will have molecular studies, including, gene arrays,     array comparative genomic hybridization, immunohistochemistry, and sequencing.      Retrospective chart review will occur to obtain relevant clinical information.   "
142071|NCT01424865|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in     samples from patients with breast cancer previously treated in the NSABP-B-31 trial.   "
142072|NCT01424852|"     Aim: to examine caries occurrence in children who ten years ago received a mixture of     probiotics during infancy.      Hypothesis: the administration of probiotics during infancy has no effect on future dental     health.   "
142074|NCT01424826|"     This study seeks to address the question of whether intermittent dosing of rifampicin     influences the pharmacokinetics of raltegravir when co-administered. This study aims to look     at what happens when rifampicin is taken 3 times a week with the standard dose and an     increased dose of raltegravir. This is to find out the best dose of raltegravir to take when     taking rifampicin 3 times a week. The study will be conducted in 18 healthy volunteers.   "
142075|NCT01424813|"     The study will measure the change in lung function in subjects with asthma after inhaling     from either of two inhalers: Albuterol Spiromax® or placebo.   "
142076|NCT01424800|"     This study emphasizes on the influence of changes in systemic flow and systemic mean arterial     blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by     near-infrared spectroscopy (NIRS). The aim of the study is to determine whether variations in     systemic flow, in MAP, or in both variables at the same time have the greatest impact on the     cerebral oxygen saturation.   "
142079|NCT01424761|"     Cardiovascular disease (CVD) is the leading cause of Taiwan. American Heart Association (AHA)     indicated that CVD patients with Statin therapy would decrease the recurrence of CVD. The     goal for lipid lowering in CVD patients was set at the level of low-density lipoprotein     cholesterol (LDL-C) below 100 mg/dL. Coenzyme Q10 is recognized as a lipid soluble     antioxidant, Statin treatment might affect the level of coenzyme Q10. Therefore, the purposes     of this study are going to investigate the relation of coenzyme Q10 with other antioxidant     vitamins (Vitamin A and E), the markers of lipid peroxidation, antioxidant enzymes     activities, and the inflammatory markers in coronary artery disease (CAD) patients during     Statin therapy. The study is going to design a placebo-controlled study. The investigators     will recruit coronary artery disease (CAD) patients who are identified by cardiac     catheterization as having at least 50% stenosis of one major coronary artery, and healthy     subjects. CAD subjects are randomly assign to placebo and coenzyme Q10 supplements (150     mg/bid = 300 mg/d) groups. Intervention is going to administration for three months. Fasting     blood will be obtained in each month and determine the concentration of antioxidant vitamins,     lipid peroxidation markers, antioxidant enzymes activities after intervention. Meanwhile, the     investigators will measure the level of inflammatory markers in all subjects of this study.     Hopefully, the results of this study could provide information of coenzyme Q10     supplementation for clinical dietitian in advising CAD patients who are under Statin therapy.   "
142080|NCT01424748|"     For 28 days, healthy volunteers will consume one of four daily quantities of Tahitian Noni     juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. Hematology, biochemistry, urinalysis, vital     signs, and adverse events measurements will be made at 0 (baseline), 2, and 4 weeks, as well     as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements will also be     made for each volunteer during the pre-study screen and at week 6.   "
142082|NCT01424722|"     This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption     (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the     ST Monitoring Feature in St Jude Medical ICD systems.   "
142083|NCT01424709|"     Gemcitabine, docetaxel, CPT-11 and cisplatin are effective in 1st line treatment of advanced     non-small cell lung cancer (NSCLC). Platinum-based doublets including gemcitabine, docetaxel     or CPT-11 are standard 1st regimens. BRCA1 and RRM1 expression levels are reported to be     associated with sensitivity of the tumor cells to cytotoxic agents. Some Phase II or III     trials did prove feasibility of customized chemotherapy based upon expression levels of one     or two biomarkers in the NSCLC patients. The investigators think customized chemotherapy may     further improve efficacy of chemotherapy in advanced NSCLC. But there is no randomised trial     to compare efficacy of standard chemotherapy with individualized chemotherapy in this     setting. So, the investigators plan to initiate this phase II trial to compare efficacy     between standard chemotherapy of gemcitabine/cisplatin versus customized chemotherapy in     chemonaive NSCLC patients.   "
142084|NCT01424696|"     Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive     problems, but can now be diagnosed at the time of birth. Lung function is very hard to     measure in infants, but growth is not. In this study the investigators aim to define growth     in infants with CF in the first year of life with research quality precision and to     understand factors that interfere with good growth.      Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of     infants. Two different doses of PERT will be evaluated for improving fat and nitrogen     absorption in infants with CF.   "
142085|NCT01424683|"     The objective of this study is to investigate how mobility and pain scores, measured on a     Visual Analogue Scale (VAS), correspond to patients' EuroQol-5Dimensions-3Levels (EQ-5D-3L)     answers on pain and mobility. In addition, the investigators want to evaluate patients'     undergoing Coronary Artery Bypass Grafting (CABG) quality of life postoperatively, depending     on the vein harvesting method used.   "
142086|NCT01424670|"     The purpose of this trial is to determine whether delamanid is effective in the treatment of     Multidrug-resistant Tuberculosis (MDR TB) in combination with other MDR TB medications during     6 months of treatment.   "
142087|NCT01424657|"     The main objective of this study is to assess the effectiveness and costs of magnetic     resonance cholangiopancreatography (MRCP) and compare it to endoscopic retrograde     cholangiopancreatography (ERCP) in the work up of patients with suspected bile duct     obstruction on ultrasound. The investigators do not anticipate that a universal     recommendation for a given diagnostic test (MRCP versus ERCP) will be applicable in all     patients presenting with bile duct obstruction. Rather, the investigators hope to provide     quantitative and comparative data relevant to the different clinical situations likely to be     encountered in practice, in order to assist physicians in choosing the appropriate diagnostic     modality. More specifically, the investigators feel that patients with intrahepatic or hilar     obstruction (particularly those with malignant conditions), and those with partial common     bile duct (CBD) obstruction (to rule out suspected choledocholithiasis) will benefit most     from this new technology and the avoidance of an unnecessary ERCP to further determine the     biliary anatomy.   "
142088|NCT01424644|"     The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline,     Boostrix®) and HPV vaccine (Merck & Co., Inc., Gardasil®) when administered concomitantly     with MenACWY are comparable to responses elicited by these vaccines when given alone.   "
142089|NCT01424631|"     This is a randomized prospective study comparing single incision versus conventional     laparoscopic appendectomy for management of acute appendicitis.   "
142090|NCT01424618|"     This study compares two different methods to prepare the uterine lining of recipients for     implantation in cycles using donor eggs. The study method requires less time than the     standard method.      It is hypothesized that both methods would be suitable for use in egg donor cycles.   "
142413|NCT01420419|"     The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of     painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has     an effect on breastfeeding outcomes such as duration and exclusivity.   "
142091|NCT01424605|"     Double-lumen bronchial tube (DLT) had been demonstrated to benefit for thoracic surgery and     also played an important role to achieve one-lung ventilation (OLV) for exploring the     surgical fields. However, compared with the single-lumen endotracheal tube (SLT), the DLT had     larger OD (outer diameter), longer length, and was more complex in its structure. For     avoiding oral tissue trauma and shortening the DLT intubating time, thus, an adequate and     complete glottic viewing under laryngoscope was needed.      Over the past decade, several video-assisted laryngoscopes had been developed to facilitate     the tracheal intubation in the difficult airway. Among these devices, the GlideScope®     videolaryngoscope (GVL) (Verathon, Bothell, WA, USA) was a reusable video laryngoscope with a     60° curvature blade. A light source and a digital video camera were installed at the tip of     the laryngoscope blade and the pictures of the glottis and the vocal cords were displayed on     an LCD monitor. We could insert the endotracheal tube passing the vocal cords into the     trachea more precisely and had less tissue damaging under the GVL's guidance.      Compared with direct MacIntosh laryngoscope, the GVL had been reported that it can decrease     the intubation time and increase the successful rate of first intubation in normal and     difficult airways. However, the efficacy of the GVL in intubating the DLT was unclear and had     never been evaluated. Therefore, the aim of this study was to compare the intubation     conditions, safety, and patient comfort between using the GVL and the direct Macintosh     laryngoscope in a specific population of patients needed DLT intubation. Main outcome     measures were intubation success rates and the time needed to intubate the DLT with the two     devices.   "
142092|NCT01424592|"     Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA     is accurate in determining the need for positive airway pressure (PAP) therapy when compared     to outpatient laboratory-based polysomnography.        -  Hospitalized medical inpatients referred for suspected OSA will be tested with a          portable sleep apnea testing device during hospitalization.        -  These patients will then undergo an outpatient laboratory-based attended polysomnography          after hospital discharge.        -  Results of the inpatient portable sleep apnea test will be compared to the outpatient          laboratory-based polysomnography in terms of diagnostic accuracy.   "
142118|NCT01424254|"     The study objective is to compare the cost-effectiveness of VCE to push enteroscopy in     patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.   "
142093|NCT01424579|"     Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high     lifetime prevalence (one in three) in general population. In occupational population is the     most common upper extremity disorder. Symptoms include pain, a variable degree of mobility     limitation and a more or less pronounced functional impairment. Conservative treatment is     usually the first therapeutic option and some physiotherapeutic techniques have proved its     efficacy but nevertheless treatment remains challenging.      According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial     effect on patients suffering from SIS, but no one published clinical trial has evaluated this     manual technique previously. The investigators hypothesis is that adding Diacutaneous     Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The     investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility     and functional status in patients suffering from SIS.      A double-blind (patient and evaluator) randomized clinical trial was carried out in two     public centres of Primary Health Care of the Spanish National Health System. The study     protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute     of Research in Primary Health Care and all the patients provided written consent.      A hundred and twenty patients with clinical diagnosis of SIS were included and randomly     allocated to one of three groups. All groups received the same daily protocolized treatment     based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks.     Additionally, intervention group received six sessions (two a week) of actual Diacutaneous     Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous     Fibrolysis, while control group received only the protocolized treatment.      Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and     internal rotation) and functional status (Constant-Murley score) were measured in baseline,     after the three weeks of treatment and three months after the end of treatment.   "
142094|NCT01424566|"     The primary objective of this study is to determine the efficacy of Sativex, compared with     placebo, an adjunctive medication in relieving persistent chronic pain (not breakthrough     pain) in patients with advanced cancer, who have this pain even when they are on     optimized/maximized chronic opioid therapy.      This multi-center study will be conducted in two parts. All participants enrolled into the     trial will receive Sativex during one of two parts of the study, but they will not know which     part.      Eligible patients will not be required to stop any of their current treatments or     medications.   "
142095|NCT01424553|"     EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be     evaluated in very low birth weight and term infants, born in 1997 and included in the French     EPIPAGE cohort.   "
142096|NCT01424540|"     This is a single-center, randomized, two part, double-blind, crossover study in healthy adult     subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function     comparing with placebo using echocardiography as a primary assessment modality   "
142097|NCT01424527|"     This is a cross-sectional validation study, designed to evaluate the discriminative validity     of the Chronic Obstructive Pulmonary Disease Assessment Test translated in a local language     in patients with Chronic Obstructive Pulmonary Disease.   "
142098|NCT01424514|"     The purpose of this study is to assess the pharmacodynamic (PD) effects (Total Symptom Score     (TSS) and its individual components: rhinorrhoea, nasal congestion, post-nasal drip) of     intranasal, repeat dose SB-705498 in non-allergic rhinitis (NAR) patients elicited by a cold     dry air challenge in an environmental exposure chamber (EEC). SB-705498 is a selective     antagonist of the transient receptor potential vanilloid-1 (TRPV1) ligand gated ion channel.     TRPV1 is a cation permeable ion channel that can be activated by several physiological     factors, such as heat, protons (pH), osmotic stress, eicosanoid derivatives, anandamide, and     by products of inflammation, such as histamine, prostaglandins and bradykinin. In the nose,     the local TRPV1 expressing sensory C-fibres are thought to play a key role in the development     of nasal hyper-responsiveness to environmental provocateurs. It has been proposed that     blocking the nasal sensory nerve stimulation may control nasal hyper-responsiveness and     therefore prevent the induction of rhinitis symptoms. In this context, preclinical evidence     supports that targeting TRPV1 by SB-705498 may be an attractive option.      In this study NAR patients will be randomised, in a double blind, placebo controlled cross     over design to receive 14 day repeat doses of 12mg intra-nasal SB-705498 once daily. Whilst     dosing at home, subjects will record symptom scores to document their symptoms. In addition,     during visits to the clinical unit, acoustic rhinometry, quality of life questionnaires and     safety assessments will be monitored.   "
142113|NCT01424319|"     Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The     objective of the study is to evaluate the efficacy and safety of once daily administration of     atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2     diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose     for hypertension of a RAS (renin angiotensin system) inhibitor.   "
142100|NCT01424488|"     Primary objectives:        1. to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at          reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in          subjects undergoing abdominal surgery under general anesthesia        2. to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex          administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular          blockade      Secondary objectives:      1. to evaluate the time from the start of sugammadex or placebo administration to the time of     extubation and to the time of recovery of TOF ratio to ≥ 0.9      Exploratory objectives:        1. to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay          after the end of surgery in subjects with pipecuronium induced neuromuscular blockade          reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline)        2. compare the number of patients extubated in the OR after the reversal by sugammadex or          placebo, evaluate the TOF ratio at the time of extubation      Clinical hypothesis:      1. Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced     blockade   "
142101|NCT01424475|"     The Leucine-Rich Repeat Kinase 2 (LRRK2) is implicated in autosomal dominant Parkinson's     disease (PKD). An inhibitor for the leucine-rich repeat kinase 2 (LRRK2) is in pre-clinical     development for potential use in treating Parkinson's disease. Patients with PKD have     cognitive impairments which develop alongside the typical motor symptoms but a full     characterisation of the neurocognitive phenotype of PKD patients with LRRK2 mutation is     currently lacking. This observational study conducted on a single visit will assess the     phenotypic neurocognitive abnormalities of PKD patients with the LRRK2 mutation with the aim     of identifying potential PD endpoints related to the LRRK2 mutation for future Phase I or II     clinical trials of LRRK2 inhibitors.   "
142119|NCT01424241|"     This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF1)     normalization into current IGF1 normal ranges with Sandostatin LAR® therapy on biochemical     metabolic, cardiovascular and body composition parameters in patients with active acromegaly.   "
142102|NCT01424462|"     This study will investigate how 3 new types of drug formulations are absorbed by the body.     This study is termed 'open-label', which means volunteers will be aware of which treatment     they are receiving. The study involves all volunteers receiving all 3 different formulations,     as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study.     Volunteers will also receive a single dose of a formulation used in previous trials     (reference formulation), so as a proper comparison with the new formulations can be made. One     of the new formulations will also be administered along with food, to assess if the drug     performs or is absorbed differently.   "
142103|NCT01424449|"     This will be an open label, non-randomised [11C]PHNO PET study using healthy male volunteers.     Each volunteer will undergo 4 [11C]PHNO PET scans to allow for further characterisation of     this radioligand and examine the effects of [11C]PHNO mass carry-over and displaceable     binding in the brain. This study aims to obtain data from 6 evaluable subjects.   "
142104|NCT01424436|"     Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild     Alzheimer's disease or mild cognitive impairment   "
142105|NCT01424423|"     The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein     that prevents nerve growth.      The trial is expected to involve approximately 36 patients. The study objective is to     investigate the tolerability, safety and the way the body handles GSK1223249 after a range of     single doses in patients with Multiple Sclerosis (MS).   "
142106|NCT01424410|"     Objective and Hypotheses: This project has the overall objective of implementing and     evaluating new approaches to reducing the current and future burden of urinary     schistosomiasis in young children using the antihelminthic drug praziquantel. The     investigators hypotheses are that (1) praziquantel treatment will be as effective in children     1 to 5 years of age (who are routinely excluded from schistosomiasis control programmes) as     it is in older 6-10 year old children and (2) two treatments will be more effective than a     single treatment, especially in children 1 to 5 years of age.   "
142107|NCT01424397|"     This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms     induced by an allergen chamber challenge.   "
142108|NCT01424384|"     This will be a phase I, single centre, randomised, double blind, double-dummy, placebo     controlled, parallel group single-dose study in healthy volunteers. The purpose of this study     is to assess the effect of a single-dose administration of GSK424887, a potent, selective     competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the     human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus     citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and     safety following oral administration of GSK424887 will be also evaluated. An Emotional Test     Battery (ETB) previously used to characterise the effects of antidepressants on positive and     negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise     that GSK424887 will modulate emotional information processing acutely. We anticipate that     these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy,     thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms     in humans.   "
142109|NCT01424371|"     This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the     elderly will produce greater vaccine effectiveness in their group.   "
142110|NCT01424358|"     Objective:      The experimental design is a one-site, randomized experimental web-based educational     feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the     intervention group and approximately 50% PCPs on the control group, giving a total of 159     participants. All 159 participants have willingly provided their e-mail addresses, as part of     a survey they previously completed entitled, Survey of Health Professionals on Oral Cancer     in Ohio- Intervention to Prevent Delayed Diagnosis of Oral Cancer.   "
142111|NCT01424345|"     The purpose of this study is to demonstrate whether there are any outcome benefits of a     serial ImmuKnow assays in the management of de novo renal transplant recipients.   "
142112|NCT01424332|"     The primary objective of this study is to evaluate whether ASA and darexaban which have     different effects on blood coagulation influence each other in their effects. Also it will be     investigated whether the blood levels of either drug are influenced by the presence of the     other drug. In addition, the safety and tolerability of each drug and the combination of the     drugs will be investigated.   "
142414|NCT01420406|"     The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and     beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol     concentrations in lactating Bangladeshi women.   "
142114|NCT01424306|"     People with chronic low-grade inflammation have a higher risk for certain diseases such as     cardiovascular disease or type 2 diabetes. While it is known that obese people are more     likely to show signs of low-grade inflammation than lean individuals, it is unclear what     causes this inflammation. In the proposed study, the investigators will examine whether the     sugar fructose, when consumed in a sweetened beverage, triggers low-grade inflammation in     healthy men and women compared with other caloric sweeteners.   "
142115|NCT01424293|"     Bowel removal is indicated for various types of colon and rectal disease, including colon     cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others.      Following removal of the diseased segment of bowel your surgeon will reconnect the two     healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an     extremely dangerous situation.      The cause of leakage has many causes and is not well understood, but appears to be at least     in part due to not having enough blood going to the bowel. There is currently no way to     evaluate the blood supply to the bowel.      The purpose of this study is to utilize a special camera to evaluate the blood supply of the     bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing     the occurrence of leaks   "
142116|NCT01424280|"     The purpose of this study is to assess bronchodilator effect after single dose administration     of GSK1440115 in a population of mild to moderate asthmatic patients.   "
142117|NCT01424267|"     A registry to collect additional prospective intra-operative and follow-up information on     physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA)     Endovascular Graft under routine clinical care.   "
142121|NCT01424215|"     The purpose of this study is to evaluate whether a fluorescent die and a special infrared     camera can assist with the identification of the important structures during laparoscopic     cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in     less time and in a safer fashion than standard laparoscopic cholecystectomy.   "
142122|NCT01424202|"     Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the     incidence of re-intubation and ICU length of stay. However, the role of NIV in     post-extubation failure is still not clear. Impaired airway clearance is associated with NIV     failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that     has been proven to be very effective in patients under NIV.      In this study the investigators assess the efficacy of MI-E as part of a protocol for     patients that develop respiratory failure after extubation.   "
142123|NCT01424189|"     The purpose of this study is to evaluate the safety and effectiveness of an investigational     multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.   "
142124|NCT01424176|"     This is a multicenter, open-label, single-dose, PK and safety study in subjects with various     stages of renal impairment.   "
142125|NCT01424163|"     This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK),     safety, and tolerability of dexpramipexole administered orally to adult Japanese and     Caucasian healthy subjects.   "
142126|NCT01424150|"     The optimal fluid regimen, haemodynamic (or other) targets and fluid choice (colloid or     crystalloid) for patients undergoing major surgery are based on rationales that are not     supported by strong evidence. Practices vary substantially, guidelines are vague, small     trials and meta-analyses are contradictory. The strongest and most consistent evidence, and     biological plausibility because of tissue edema, supports a restrictive fluid strategy. But     other evidence supports goal-directed therapy, requiring additional IV fluid. There is no     good evidence that use and choice of colloids improves outcome. RELIEF will study the effects     of fluid restriction, and the possible effect-modification of goal-directed therapy and     colloids. The first will be randomly assigned; the latter will be measured covariates     dictated by local practices and beliefs.      Study Hypotheses A restrictive fluid regimen for adults undergoing major abdominal surgery     leads to reduced complications and improved disability-free survival when compared with a     liberal fluid regimen.      Secondary hypothesis: The effects of fluid restriction are similar whether or not     goal-directed therapy is used (assessed as a statistical test of interaction). A restrictive     fluid regimen will reduce a composite of 30-day septic complications and mortality.   "
142127|NCT01424137|"     The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler®     (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children,     adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).   "
142128|NCT01424124|"     The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to     singulair or placebo in patients (n=96) with partially controlled asthma.      The study will conduct with 4 comparative groups orally treated with YHD001 dose level     1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.   "
142129|NCT01424111|"     The purpose of this research is to explore objective biomarkers in voice, physiological,     motor, and brain imaging signals that may one day be used to complement clinical evaluation     and treatment of depression.   "
142130|NCT01424098|"     A growing body of evidence suggests that individuals with chronic lung disease have important     deficits in balance control that may be associated with an increased risk of falls. The main     purpose of this study is to examine the effects of a balance training program on measures of     balance and fall risk in people with chronic lung disease.   "
142166|NCT01423630|"     Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease.      The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial     composition in a positive manner. The improved ecological system is believed to contribute to     improved liver health and thereby counteract fatty liver disease.   "
142131|NCT01424085|"     The purpose of this study is to evaluate the use of antibiotics (i.e. Kefzol) before     percutaneous gastrostomy performed in interventional radiology. Patient will be randomized to     receive antibiotics or placebo before the procedure, and the rates of skin infection after     the procedure will be determined between the two groups. This has never been studied in our     population of patients undergoing the procedure. However, antibiotics are routinely given     despite the lack of evidence. The investigators hypothesize that patient receiving     prophylactic antibiotics will have a decreased number of infections compared to placebo.   "
142132|NCT01424072|"     This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies     in 75 nursing professionals in a University Hospital.   "
142133|NCT01424059|"     The purpose of this study is to evaluate the experience of labor in parous women induced     because of fear of labor and, to compare the experience of parous women induced without fear     of labor. A comparison with the experience of women delivered with elective cesarean section     because of fear of labor is done.      In the induced labors, the induction method is amniotomy. Between groups the experience of     delivery is evaluated with a questionnaire: Wijma Delivery Expectancy Questionnaire(WEDQ-B).      Groups are also compared with regard to time from induction to delivery and rate of operative     delivery.      Hypotheses:        -  there is no difference in experience of delivery        -  there is no difference in time to delivery or rate of operative deliveries   "
142134|NCT01424046|"     This study is a pilot 2-armed, randomized, open label, clinical trial evaluating the     effectiveness of a basal approach to diabetes management as compared to the current standard     treatment (regular/NPH).      Patients seen at the Association Rwandaise des Diabetiques (ARD) will be invited to     participate in the study and consent will be obtained by the investigation team. This will     continue until 40 patients have been enrolled at which time recruitment will be started at a     provincial hospital, at which 10 further participants will be recruited. Participants will be     consenting to 1) Randomization to basal or current insulin treatment arm and 2) Permission     for use of clinical data for research.Participants will be followed every six months for a     period of 24 months. The first 6 months will be a wash in period and participants will be     randomised (1/1) to their treatments at the 6 month visit.   "
142137|NCT01424007|"     The purpose of the MENU Study is to examine whether there is a differential weight loss     response to different dietary macronutrient composition (higher carbohydrate and lower fat     versus lower carbohydrate and higher monounsaturated fat [MUFA] or lower carbohydrate and     walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending     on insulin resistance status. Blood samples will be collected to enable analysis of potential     mechanisms and differential response across subgroups.   "
142138|NCT01423994|"     Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits,     and probably is responsible for CDN $250 million in health care spending each year. It is     associated with decreased quality of life, trauma, loss of employment, and limitations in     daily activities. It is a particular problem for older people, partly because of increased     frailty, and partly because of a difficult differential diagnosis. One of the causes in older     adults is intermittent complete heart block in the setting of bifascicular heart block, but     they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several     neurally mediated syncopes. Often treatment decisions should be made before the true cause is     apparent.   "
142139|NCT01423981|"     This trial intends to gather very basic clinical information about keloid, its patterns of     presentation, family history, ethnic background and correlation with the type of keloid, as     well as prior treatment results that patients have had received.   "
142140|NCT01423968|"     The investigators aim to examine how the skeletal muscles of the human volunteers respond to     experimental septic conditions to aid understanding of muscle wasting and its biology..      Six healthy men aged 18-30 will be randomly assigned to two metabolic study visits. On the     first visit, while resting on a bed, they will have four cannulae inserted including one in     the upper thigh, for blood sampling and the infusion of insulin, glucose and normal and     tracer amino acids (which allow us to measure muscle protein metabolism). Subjects will     receive either injection of purified bacterial product called lipopolysaccharide (LPS) to     induce flu-like symptoms or normal saline according to randomization followed by a metabolic     test to stimulate muscle synthesis and glucose transport. Three small samples of muscle will     be obtained under local anaesthetic from the thigh to measure molecular events in muscle. By     performing these measurements, the investigators will determine the consequences of LPS on     muscle production and carbohydrate metabolism.   "
142141|NCT01423955|"     The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and     degree of acute kidney injury after cardiac surgery.   "
142142|NCT01423942|"     The purpose of this study is to try to evaluate the maturation of the autonomic nervous     system in prematures.   "
142143|NCT01423929|"     The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and     during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction     (STEMI). One hundred STEMI patients are randomized in the ambulance to either standard O2     treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI.     Cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to     assess infarct size and myocardial performance. All patients are followed for 6 months. At 6     months, perceived health and NT-proBNP are recorded for all patients, and an additional     echocardiography is performed. The primary endpoint is the fraction of myocardium saved with     the acute PCI. The secondary endpoints include the pain difference between inclusion time and     start of PCI and myocardial performance on echocardiography.   "
142411|NCT01420445|"     The study will conduct with 4 comparative groups orally treated with YHD001 dose level     1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo     for 7 days.      The treatments will be assigned randomly to patients (n=116) with acute or chronic     bronchitis.   "
142144|NCT01423916|"     The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and     adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective     subjects. The goals of this trial are three-fold:        -  To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for          placebo        -  To determine the effect of moxifloxacin on QTcI        -  To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI   "
142145|NCT01423903|"     The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given     daily by mouth to subjects with advanced solid tumors.   "
142146|NCT01423890|"     A prospective population-based cohort study is being conducted in Ontario to evaluate whether     the performance of Oncotype DX® changes the treatment recommended and the treatment received     in women or men with node negative, ER positive breast cancer who are receiving (or will     receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible     consenting women and men will have their tumor tissue specimen sent to Genomic Health where     the Oncotype DX® assay will be performed.   "
142147|NCT01423877|"     Specific Aims & Hypothesis Primary Aim: To evaluate laparoscopic bariatric surgery versus     intensive medical weight management on indices of insulin resistance and resolution of type 2     diabetes among patients with BMI 30-35.      Hypothesis: Bariatric surgery is the most effective treatment to induce diabetes remission in     obese diabetic patients BMI 30-35.      The primary outcomes will be assessed at 6 months: (1) within-patient change in insulin     resistance after either bariatric surgery or initiation of intensive medical weight     management, and (2) remission of diabetes, (i.e., fasting glucose <126mg/dL and glucose     <200mg/dL two hours after a standard 75g oral glucose load without the use of     anti-hyperglycemic medications). Insulin resistance will be assessed at randomization and at     6 months with the homeostatic model assessment of insulin resistance (HOMA IR) based on     insulin and fasting glucose, as well as oral glucose tolerance tests with     area-under-the-curve (AUC) measurement for insulin values. Medication discontinuation will be     derived from electronic health records and patient self-report at 6 months. Secondary     outcomes will include changes in HBA1c, weight, blood pressure, waist circumference, and     levels of fasting lipids.   "
142234|NCT01422746|"     This study will test whether metformin administration can ameliorate androgen (male hormone)     overproduction in overweight pubertal girls with androgen excess. The investigators     hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration     will improve androgen levels after adrenal stimulation testing with adrenocorticotropic     hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin     (rhCG).   "
142148|NCT01423864|"     Acute respiratory distress syndrome (ARDS) in combination with multi-organ dysfunction     syndrome (MODS) is a life-threatening condition, particularly when treatment modalities such     as extracorporeal membrane oxygenation (ECMO) and catecholamine administration have failed to     treat the severe condition. In this study, the investigators report patients who responded to     intrapleural steroid instillation (IPSI) while being unresponsive to conventional treatment     (use of intravenous steroids, nitric oxide inhalation, high-frequency oscillatory     ventilation, or ECMO) for treatment of critical illnesses such as ARDS in combination with     MODS.   "
142149|NCT01423851|"     The purpose of this study is to determine the safety and tolerability of orally administered     NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis     (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)   "
142150|NCT01423838|"     Null hypothesis of the trial is that there is no difference between solifenacin and     oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life     measures in patients with overactive bladder.   "
142151|NCT01423825|"     This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and     immune response to an HIV envelope protein vaccine boost in people who have previously     received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102     study.   "
142152|NCT01423812|"     Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that     evolved from a prototype compound synthesized using structure-based design strategies.     Once-daily darunavir at 800mg boosted with 100mg of ritonavir is an effective antiretroviral     agent indicated for HIV-infected treatment-naïve patients. In treatment-experienced patients,     darunavir was initially approved for twice-daily administration boosted with twice-daily     ritonavir at 600mg and 100mg, respectively. Recently, once-daily darunavir/ritonavir was     approved for use in treatment-experienced adult patients with viremia with no darunavir     resistance mutations. In treatment-experienced patients with viral suppression, switching     from an antiretroviral taken twice-daily to a once-daily dose is an attractive option to     promote greater patient acceptability and adherence, and potentially minimize side effects     and toxicities. Because of darunavir/ritonavir's high genetic barrier to resistance and     well-established safety profile at a once-daily dose, switching patients with virologic     suppression from twice-daily darunavir/ritonavir to once-daily darunavir/ritonavir will     likely confer attributes more favorable to patients through a simplified dosing schedule and     lower potential for lipid elevation without the loss of virologic control. DRIVESHAFT is a     48-week Phase 4, randomized, open label, comparative study. The study will be conducted in 60     HIV-1 infected, antiretroviral experienced, virologically-suppressed patients on regimens     containing darunavir 600mg/ ritonavir 100mg twice-daily and a minimum of two other     antiretrovirals, with a history of 0-1 darunavir-associated resistance mutations. Subjects     will be randomized 1:1 to switch to darunavir 800mg/ ritonavir 100mg once-daily or continue     on their current regimen. Rates of virologic suppression of once-daily darunavir/ritonavir     regimens relative to darunavir/ritonavir twice-daily regimens will be compared, and safety,     change from baseline fasting lipid parameters, and adherence will be evaluated.   "
142153|NCT01423799|"     The purpose of this study is to compare the health-related quality of life following dietary     supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet     supplement in patients suffering from upper digestive tract neoplasia undergoing oncological     treatment.   "
142154|NCT01423786|"     This is a prospective trial for children with the diagnosis of mild acute pancreatitis     admitted to the hospital for continued management. Patients will be enrolled in the study     within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled.     Demographic, laboratory and imaging data done as standard of care will be collected and     additional blood work will be sent as part of the study. Patients will be followed     prospectively with regards to tolerance to oral nutrition, pain, length of stay and     complications. The hypothesis is that patients that are able to tolerate early oral nutrition     will have shorter length of stays and will be similar in terms of pain score ratings,     readmission rates, complications and the need for invasive supplemental nutrition. Also     patients that are able to tolerate early oral nutrition will have less significant elevation     of biochemical markers of pancreatitis severity when compared to patients that do not     tolerate early oral nutrition and historical controls.   "
142155|NCT01423773|"     The purpose of this study was to compare the fit and comfort of two types of contact lenses.   "
142167|NCT01423617|"     The intention of the study is to evaluate the safety and potential body weight and body fat     loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind,     placebo-controlled, parallel study conducted in Caucasian subjects.      This study will also include a diet plan for each subject, calculated based on gender, age,     and energy requirements; and adjusted to be slightly hypocaloric.   "
142156|NCT01423760|"     This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA,     EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in     this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25).     Subjects were transferred once the feeder trial (EMR 63325-005 [NCT00157209], EMR 63325-006     [NCT00157196] and EMR 63325-008 [NCT01094548]) objectives were met. Subjects who received     tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this     follow-up trial and have safety assessments performed as well as were observed for     progressive disease (PD) and survival in 6- month intervals. Subjects who had not received     tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD     and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).   "
142157|NCT01423747|"     With this protocol the ALL-SZT BFM international study group wants      to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or     unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).      to evaluate the efficacy of haematopoietic stem cell transplantation (HSCT) from mismatched     family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor     (MSD) and matched donor (MD).      to determine whether therapy has been carried out according to the main haematopoietic stem     cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment     options during haematopoietic stem cell transplantation (HSCT) from different donor types     aims at the achievement of an optimal comparison of survival after HSCT with survival after     chemotherapy only.      to prospectively evaluate and compare the incidence of acute and chronic graft-     versus-host-disease (GvHD) after haematopoietic stem cell transplantation (HSCT) from matched     sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).   "
142194|NCT01423266|"     This research project was designed to study the role of dietary modifications in heart     failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically,     the purpose of this study is to determine whether or not heart failure patients participating     in a 3-month intensive lifestyle modification program of either a high protein (30 % of total     calories from protein) group will have a significant improvement in weight reduction, quality     of life and clinical outcomes compared to a standardized protein (15% of total calories from     protein) group.   "
142158|NCT01423734|"     Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used to     see how tumors respond to treatment. If tumors shrink after therapy, doctors continue with     the same treatment. On the other hand, growing tumors in a patient can bring about a change     in therapy. Unfortunately, it often takes three to six months, or even longer before the     investigators see tumors shrink or grow on scans. Doctors are looking for new imaging tools     that can look at how tumors respond early on during treatment. This study will help us decide     if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a helpful     imaging tool.   "
142159|NCT01423721|"     The objective of the current study is to investigate relative bioavailability of bromhexine     hydrochloride given as granules and syrup   "
142160|NCT01423708|"     Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.   "
142161|NCT01423695|"     The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of     advanced breast cancer based on a large pivotal study. However, mono and combination     chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially     in the palliative setting. The present trial examines the efficacy and safety of weekly     paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.   "
142162|NCT01423682|"     Patients with rotator cuff tendinopathy make up a large part of the population in     physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in     causing pain. Tendons suffer large compression and friction, which can lead to degeneration     of these tendons. Rehabilitation often leads to unsatisfying results.      In Achilles and patella tendinopathy, a new training program called eccentric training has     shown very good results. Eccentric training contains exercises during which a force has to be     resisted while the muscle lengthens instead of shortens. This would have a larger influence     on tendon tissue. Some small studies also show promising results of eccentric training in     patients with rotator cuff tendinopathy but the mechanisms behind these results remain     unclear.      To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will     be evaluated before and immediately after performing the exercise. Three measurements will be     done: ultrasonographic measurement of tendon thickness, power Doppler imaging and measurement     of microcirculation around the tendon with Oxygen to see. All measurements are non-invasive,     pain free and without risks for the human body.   "
142163|NCT01423669|"     Purpose Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders     influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors.     Despite significant progresses in pharmacotherapy, the disorder often results in long-term     disability (ranked globally amongst the top ten leading causes of disability-adjusted life     years, DALYS), often associated with extensive cost, burden, morbidity and mortality.      Objective / hypothesis The study aims to (1) measure the prevalence of psychotic symptoms in     the Hong Kong population; (2) explore associated risk and protective factors for the     expression of psychotic symptoms; (3) characterize the functional disability in people with     psychotic symptoms; and (4) study the determinant of clinical presentation or     non-presentation in people with psychotic symptoms.      Design, subjects and study instrument The survey will be conducted with a two-phase design.     The first phase interviews will include approximately 5,000 subjects with structured     assessments serving diagnostic criteria for CMD, screening instruments for psychotic     disorder, substance misuse and suicidal behaviours, functioning, service use and     demographics. The second phase comprises of clinician interviews for psychotic disorder and     at risk mental state and other variables including neurocognitive, help seeking, stigma and     well-being.      Analysis Prevalence estimates will be weighted, expressed as rates and confidence intervals.     Comorbidity will be estimated using Latent Class Analysis (LCA) Logistic regression will be     used to identify significant factors associated with mental disorders.   "
142164|NCT01423656|"     The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data     when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.      The study is divided into one single dose part, one part to compare pharmacokinetics between     gender and one multiple dose part.   "
142165|NCT01423643|"     The chief purpose of this research is to understand how antiretroviral therapy (ART) affects     progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The     investigators study liver disease progression in a cohort of dually infected persons     according to the success of ART.   "
142168|NCT01423604|"     The purpose of this study was to determine whether ruxolitinib added to capecitabine is     effective in improving the overall survival of patients with metastatic pancreatic cancer.   "
142169|NCT01423591|"     Rheumatic Polymyalgia(PMR) is a relatively common chronic inflammatory disorder of unknown     origin which predominantly develops in elderly subjects and presents with severe pain and     stiffness in the neck, shoulder and pelvic girdles, along with increased acute phase     reactants. Systemic manifestations such as fever, anorexia and weight loss are characteristic     signatures of PMR.      Corticosteroids (CS) constitute the standard treatment of PMR. Although in most patients the     symptoms of the disease disappear after one or two years of treatment, a proportion of     patients remain CS-dependent with the subsequent CS toxicity. Open label studies have     suggested that tumour necrosis factor (TNF) antagonists lead to sustained improvement and CS     sparing effect in patients with refractory PMR.      The investigators conducted a randomised, double-blind, placebo controlled trial with     infliximab in CS-dependent patients with PMR. Patients with CS-dependent PMR (defined as     requiring ≥ 5 mg/day after at least 2 years of treatment to maintain remission or ≥ 7.5     mg/day after at least 6 months) were randomly assigned to receive Infliximab (5 mg/kg i.v) at     0, 2, 6, 14 and 22 weeks (n = 12) or placebo (n = 11) together with CS that were reduced     according to a predefined schedule. The primary outcome was the proportion of responder     patients -defined as individuals with both complete clinical and analytical remission without     receiving CS for at least three months- at 24 weeks. Secondary outcomes were cumulative CS     doses and adverse events proportion.   "
142170|NCT01423578|"     The overall purpose of this pilot study is to examine effects of Hatha yoga and     cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our     preliminary study indicated that a single session of either form of activity intervention     improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed     study will extend this preliminary research in several ways.   "
142171|NCT01423565|"     HYPOTHESIS: Constant current stimulation for STN DBS will allow better and more stable     control of Parkinson's disease symptoms than constant voltage stimulation.      Subthalamic nucleus (STN) deep brain stimulation (DBS) is an established therapy for advanced     Parkinson's disease (PD). Two types of implantable pulse generators (IPGs) are available,     differing on whether voltage or electrical current is controlled. Constant current IPGs     provide a specific electrical current and will automatically adjust the voltage depending on     the impedance, while the current applied by constant voltage IPGs will depend on the tissue     impedance that may change over time. No study has compared the clinical differences of these     two electronic modalities.   "
142172|NCT01423552|"     The ongoing success of transplantation is largely due to the development of drugs to stop the     patient's body from rejecting the new organ. In addition to steroids, two main types of drug     are used to suppress the immune system following heart transplantation: calcineurin     inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients     respond in different ways to these drugs, with the same dose leading to different levels of     the drug in the blood. This varies due to genetic and other factors such as age, kidney     function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the     blood are routinely measured and the dose adjusted accordingly. However, some patients still     experience episodes of rejection despite apparently acceptable levels. In this study, the     investigators will measure levels of the drugs (in the blood, in a type of white blood cell     called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The     investigators will compare these levels with patient genetic factors and the amount of     rejection measured on heart biopsies. This will enable us to better understand how the blood     and tissue levels of these drugs change with genetic and other factors in order to optimise     immunosuppressive therapy and further improve outcomes from heart transplantation.   "
142173|NCT01423539|"     This randomized, open-label, multicenter study will evaluate the efficacy and safety of     navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large     B-cell lymphoma. Patients will be randomized to receive navitoclax in addition to     bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.   "
142174|NCT01423526|"     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and     pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.   "
142175|NCT01423513|"     The purpose of this study is to examine the effects of ankle taping on improving muscle     function and ankle motion in individuals who frequently twist (sprain) their ankle. It is     thought that ankle taping may increase muscle function and ankle motion which would benefit     individuals who frequently sprain their ankle.   "
142176|NCT01423500|"     With this protocol the ALL-SCT BFM international study group wants        -  to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family          or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).        -  to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from          mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling          donors or matched donors.        -  to determine whether therapy has been carried out according to the main HSCT protocol          recommendations. The standardisation of the treatment options during HSCT from different          donor types aims at the achievement of an optimal comparison of survival after HSCT with          survival after chemotherapy only.        -  to prospectively evaluate and compare the incidence of acute and chronic          Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from          matched donor (MD) and from mismatched donor (MMD).   "
142177|NCT01423487|"     Some previous studies has demonstrated that Metformin can improve the weight gain which     caused by antipsychotics. An our study, which will be published, also found that Metformin     can improve the amenorrhea for patients with antipsychotics, approximately 60% patients     recovery period. So the present study was designed to investigate the efficacy and safety of     Metformin in preventing patients with Risperidone from weight gain and amenorrhea.   "
142178|NCT01423474|"     The purpose of this study is to compare the toxicity of two new radiation schedules for the     treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered     every other day over 11 days, or once per week over 29 days. Both of these schedules are     shorter than the standard treatment which is usually 39 treatments over 8 weeks.   "
142215|NCT01422993|"     The purpose of this study is to evaluate the effects on strength, balance, and neuropathic     symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group     exercise program designed to improve lower extremity strength and balance with persons with     oxaliplatin induced peripheral neuropathy.   "
142179|NCT01423461|"     Individualized health care refers to the development of strategies for disease management     and health promotion that are informed by specific data on genetics and physiological     processes that uniquely determine each person's health profile and potential responsiveness     to interventions or susceptibility to environmental exposures.      Asthma, an inflammatory disorder of the airway, appears to be determined by multiple     interacting genetic and environmental factors. Such risk factors include allergic responses,     small airways, excess body weight, specific properties of airway smooth muscle, airway and     generalized metabolic and inflammatory homeostasis, and exposures to environmental irritants,     allergens, and psychosocial stressors. To date, asthma treatment strategies have been guided     by severity guidelines rather than by characteristics of the child's specific phenotype (a     child's underlying allergic tendency, extent of airway inflammation and airway smooth muscle     dysfunction, or underlying obesity and metabolic perturbations). The growing availability of     new classes of asthma medications that more directly target specific pathophysiological     derangements will require accessing data on each child's asthma risk profiles to optimize     selection of medications and other interventions that most specifically address the     underlying pathophysiology while minimizing adverse treatment side effects.      The investigators propose to develop a model program for collecting relevant clinical     information and genetic data on a high risk group of asthmatic children, including data on     common co-morbidities, specifically obesity and sleep disorders; use this information to     develop a comprehensive model database for characterizing children according to their health     profiles; and use this characterization to initiate targeted interventions, while continuing     long term follow up of these children to determine differential responsiveness to     medications.   "
142195|NCT01423253|"     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with     mixed features.This clinical study is designed to test how well Lurasidone works to treat     major depressive disorder with mixed features over time.   "
142196|NCT01423240|"     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with     mixed features.This clinical study is designed to test how well Lurasidone works to treat     major depressive disorder with mixed features.   "
142180|NCT01423448|"     This study is a randomised controlled trial that aims to examine the efficacy of an     established online bulletin board for depression. It has been estimated that millions of     people worldwide use peer-to-peer bulletin boards, forums or internet support groups (ISGs)     for health conditions. However, little is known about the effectiveness of these groups in     terms of symptom reduction or improvement in quality of life. The current project     investigates the effectiveness of an established online bulletin board for depression     available to the public. To our knowledge, this is the first randomised controlled trial of     the effectiveness of a pre-existing, well-established online bulletin board for depression in     the community. The aims of the project are to determine whether the bulletin board improves     mental health, quality of life, and related outcomes among members of the community with high     levels of self-reported psychological distress and previous history or current experience of     depression.   "
142181|NCT01423435|"     A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and     South Korean non-elderly healthy adult males.   "
142182|NCT01423422|"     The investigators have previously shown that a frequency of 15.95-16.00 Hz protects against     acute myocardial infarction in rats. In the current study the investigators would like to     investigate whether this frequency enables cardiac patients with exercise-induced chest pain     to exercise at higher workload and heart rate. Therefore, patients will undergo two exercise     stress tests, one test after being exposed to 30 minutes of the above mentioned frequency and     another test after being exposed to sham (no frequency is turned ON). The investigators will     measure changes in the electrocardiogram (ECG), workload, exercise time, and subjective     measure of chest pain (angina).   "
142183|NCT01423409|"     The purpose of this study is to assess an innovative Visual Analogue Scale of pain (pictorial     VAS) versus the usual VAS (VAS) among Deaf People.      The assumption of this study is that pictorial VAS is more suited to Deaf people than usual     VAS.   "
142184|NCT01423396|"     Three quarters of patients with Alzheimer's disease have at least one vascular risk factor     (VRF). Vascular brain lesions are present in most Alzheimer's patients (especially older     ones). This cerebrovascular disease potentiates Alzheimer's lesions in early-stage disease.     Many research studies have shown that VRFs are also risk factors for Alzheimer's disease;     this is true for arterial hypertension and dyslipidaemia in particular and, to a lesser     extent, diabetes and cardiopathy. Moreover, recent drug trials (SYST-EUR, PROGRESS and HOPE)     have indicated that antihypertensive medications can prevent the appearance of dementia (and     notably Alzheimer's disease) in over-60 hypertensive subjects. An observational study of 233     Alzheimer's patients with an average follow-up period of 4 years has shown that the annual     decline in the Mini-Mental State Examination (MMSE) score was lower in patients in whom all     the VRFs were being treated than in patients in whom no VRFs were being treated (1.5 ± 2.5     points versus 2.5 ± 2 points, respectively; p<0.04).1 However, it is not currently known     whether optimal treatment of VRFs can influence the progression and prognosis of Alzheimer's     disease. Answering this question could have a significant impact on public health.   "
142185|NCT01423383|"     Although keloid is a very common condition; there are no statistics as to its true incidence     and prevalence, neither in United States, nor elsewhere in the world. This trial intends to     capture epidemiological data about this disease in a large population sample.   "
142186|NCT01423370|"     The objective of this study is to assess the safety and efficacy of oral YHD1023 5g or 10g on     erectile dysfunction to investigate the optimal recommended dosage. Study period is 12 weeks     including 4weeks of follow-up period without treatment. Study patients will fill in the     international index of erectile function questionnaire and life satisfaction questionnaires.   "
142187|NCT01423357|"     The aim of this study is to investigate whether distribution of condoms and condom     demonstrations by youth peer educators in venues where people meet new sexual partners in     Livingstone, Zambia, leads to increased condom use among guests socializing in these venues.   "
142188|NCT01423344|"     Background: in patients with multiple myeloma there is a raised level of a protein, named     M-protein. This M-protein is normally used to monitor disease status and evaluate response to     treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However,     the M-protein has a long half life in serum, approximately three weeks, which tend to be a     practical problem, since the investigators can first determine hereafter if the treatment is     effective.      A new assay has the possibility only to measure part of this protein, namely the light     chains, which also is measured in a blood sample. The half life of these light chains is     much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a     given treatment, thereby being able to determine earlier if the treatment should continue or     changed to another strategy.      Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum     free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under     treatment for multiple myeloma.      Method: the investigators measure sFLC in patients receiving there 1st treatment, either at     the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the     results are compared to the M-protein.   "
142216|NCT01422980|"     The purpose of this study is to determine whether the consumption of test dairy products is     effective in reducing upper gastric discomfort after 2 weeks of product consumption.   "
142189|NCT01423331|"     An Evaluation and Factor Analysis for Maternal Mental Health - The Analytic Study of the Shin     Kong Wu Ho-Su Memorial Hospital      - Objectives：        1. To construct a screening tool for domestic maternal mental health        2. To expect to find the screening timing for early assessment or intervention of domestic          maternal mental health status.        3. To explore the impact of domestic maternal mental health factors.   "
142190|NCT01423318|"     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the     safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers.     Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous     dose of either lebrikizumab or placebo.   "
142191|NCT01423305|"     The objective of the study is to assess if charcoal prevents the absorption of budesonide and     formoterol via GI track. The assessment will be based on comparing the pharmacokinetic     parameter area under the concentration-time curve.   "
142197|NCT01423227|"     Pulmonary rehabilitation is an effective treatment for people with chronic obstructive     pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers     healthcare costs. However less than 1% of Australians with COPD receive pulmonary     rehabilitation each year, due to poor access to programs and high levels of disability. This     randomised controlled trial will examine the benefits and costs of a novel, entirely     home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based     pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the     centre-based program.      We will randomly allocate 144 people with COPD to undertake either standard pulmonary     rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake     pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for     eight weeks for supervised exercise training and education. People in the home pulmonary     rehabilitation group will receive one home visit and weekly telephone calls for eight weeks,     for supervision and mentoring of exercise and provision of education. We will compare the     number of people who complete the program in each setting. We will also test whether the     groups have similar results for the standard pulmonary rehabilitation outcomes of     breathlessness, quality of life and exercise capacity, at the end of the program and 12     months later. We will compare health care costs and personal costs between groups after 12     months.      If home-based pulmonary rehabilitation can improve uptake of this important treatment,     deliver good clinical outcomes and reduce costs this will have significant and long-lasting     benefits for patients, the community and the health system   "
142198|NCT01423214|"     This study sets up the final study end point and three detailed goals as the following.      The main objective of study: This trial is done to assess the safety and benefit of robotic     resection compared with conventional laparoscopy-assisted resection for curative treatment of     patients with cancer of the mid or low rectum.      Detailed goal of study:      The primary endpoint: This study is designed to assess whether robotic surgical system     improves the quality of rectal cancer surgery, especially in total mesorectal excision     quality and a circumferential margin positivity rate      The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and     overall survival after robot and laparoscopic resection of distal rectal cancer. This study     will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological     quality (i.e. number of harvested lymph node), local recurrence, and blood loss during     surgery.   "
142199|NCT01423201|"     Transient ischemic attack (TIA) is a transient neurological deficit (speech disturbance,     weakness…), caused by temporary occlusion of a brain vessel by a blood clot that leaves no     lasting effect.      TIA diagnosis can be challenging and an expert stroke evaluation combined with magnetic     resonance imaging (MRI) could improve the diagnosis accuracy.      The risk of a debilitating stroke can be as high as 5% during the first 72 hrs after TIA.      TIA characteristics (duration, type of symptoms, age of the patient), the presence of a     significant narrowing of the neck vessels responsible for the patient's symptoms (symptomatic     stenosis), and an abnormal MRI are associated with an increased risk of stroke.      An emergent evaluation and treatment of TIA patients by a stroke specialist could reduce the     risk of stroke to 2%.      Stanford has implemented an expedited triage pathway for TIA patients combining a clinical     evaluation by a stroke neurologist, an acute MRI of the brain and the vessels and a sampling     of biomarkers (Lp-PLA2). The investigators are investigating the yield of this unique     approach to improve TIA diagnosis, prognosis and secondary stroke prevention. The objective     of this prospective cohort study is to determine which factors will help the physician to     confirm the diagnosis of TIA and to define the risk of stroke after a TIA.   "
142200|NCT01423188|"     This study is designed to provide an assessment of the change in baseline lipid parameters     with RVX000222 after 12 weeks and 24 weeks of treatment when given in addition to optimized     statin background therapy in subjects with low baseline HDL-C.   "
142441|NCT01420042|"     The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics     (PK) of NNZ-2566 in healthy volunteers, when administered orally.   "
142201|NCT01423175|"     ClAraC (consisting of one dose of clofarabine and ara-C for five days) or FLAMSA (consisting     of one dose of fudarabine, amsacrine and ara-C for four days) will be administered followed     by reduced-intensity conditioning regimen (RIC) in the setting of allogeneic stem cell     transplantation (SCT). The aim of the study is to explore the antileukemic, immunosuppressive     effects and toxicity and safety of clofarabine in combination with ara-C in the setting of     RIC allogeneic transplantation compared with the FLAMSA-protocol for patients with high-risk     acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS).   "
142202|NCT01423162|"     This study will follow a double blinded randomized controlled study design to enroll 20     apparently healthy 6 year old children. The children will be fed with two different nutrient     fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA).     Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for     stable isotope measurements and iron absorption will be calculated.   "
142203|NCT01423149|"     The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27, 36     and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal     neovascularization in subjects with pathologic myopia.   "
142204|NCT01423136|"     In moderate to high risk patients, cardiovascular complications after surgery account for     almost 60% of death after surgery. This study will randomize 140 patients into routine postop     care with Holter monitoring versus routine postop care + remote ST monitoring + Holter     monitoring. The response time to electrocardiographic (ECG) ST changes as well as the total     ischemia time will be studied.   "
142205|NCT01423123|"     The FB-8 study is designed as an open label, single arm, Phase I dose-escalation study     evaluating the combination of weekly paclitaxel with neratinib and trastuzumab in women with     metastatic, HER2-positive breast cancer. The primary aim of this study is to determine the     safety and tolerability of the three-drug combination.   "
142206|NCT01423110|"     This study will assess the efficacy, safety and tolerability of BYM338 in patients with     sporadic Inclusion Body Myositis   "
142230|NCT01422798|"     The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high     TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of     the new WHO recommended TB drug dosages.   "
142207|NCT01423097|"     Estimate the prevalence of self-reported osteoarthritis and its characterization in adults     over 45 years of age:        -  Characterization of self-reported patients with OA (socio-demographic, comorbidities,          VAS for intensity of pain)        -  Characterization of OA diagnosis in patients with self-reported OA        -  Impact of self-reported OA in the working abilities, quality of life and functionality          (SF-12 v2.0)        -  Characterization of treatment approaches (therapeutic and non-therapeutic) for          self-reported patients with OA        -  Patient perception of impact of OA in its life and importance given to disease   "
142208|NCT01423084|"     The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1     to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum     bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup     B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean     concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary     vaccination course of two doses administered one month apart.   "
142209|NCT01423071|"     The purpose of this study is to determine the prevalence of pulmonary hypertension (PH) among     patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the     quality of life in those patients with concomitant PH compared to COPD patients without PH     and those only suffering from pulmonary arterial hypertension (PAH) respectively.   "
142210|NCT01423058|"     The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential     thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite     of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN     share a range of biological, pathological, and clinical features including the relative     overproduction of one or more cells of myeloid origin, growth factor independent colony     formation in vitro, marrow hypercellularity, extramedullary hematopoiesis, spleno- and     hepatomegaly, and thrombotic and/or hemorrhagic diatheses (Tefferi et al., 2005).      This is a multi-centre, open-label, non-randomized, dose-escalation study, to be conducted in     two phases: a dose-escalation phase (Part 1), to determine the safety and tolerability of     momelotinib (CYT387), and to identify a therapeutic dose for the expanded cohort; and a     dose-confirmation phase (Part 2), which will be a cohort expansion at or below the MTD of     momelotinib.      In the Part I dose-escalation phase of the study, subjects will be assigned to dose levels in     successive cohorts starting with a dose in the first cohort of 200 mg BID (twice daily with     doses taken approximately 12 hours apart). Doses will be escalated by 50 mg BID per cohort     until dose-limiting toxicities are observed. The dose level at which ≥2 of 6 subjects develop     a first cycle dose-limiting toxicity (DLT) is defined as the DLT level. The maximum tolerated     dose (MTD) is defined as the dose level below the DLT level. New dose levels may begin     accrual only if all subjects at the current dose level have been observed for a minimum of 28     days from the first day of treatment. The dose level chosen for study in the dose     confirmation phase of the study will be the MTD or a lower dose shown to have significant     clinical activity (efficacy) as determined by the safety review committee. Subjects will be     evaluated weekly for the first cycle, every 2 weeks during cycle 2, then monthly for 4 cycles     for a total of 6 cycles.      In the dose-confirmation phase of the study, approximately fifty (50) subjects will be     treated at the MTD or at a lower dose shown to have significant clinical activity (efficacy)     as chosen by the Safety Review Committee. In the dose confirmation phase of the study     subjects will be evaluated every 2 weeks during the first treatment cycle, and then monthly     for 5 cycles for a total of 6 cycles.   "
142211|NCT01423045|"     The study hypothesis is that urine concentrating ability can predict the rate of kidney     function decline.      Patients with kidney disease at the investigatorsclinic will be asked to give first morning     urine sample and osmolarity will be measured. The investigators will follow up kidney     function decline and check if there is association with urine osmolarity.   "
142212|NCT01423032|"     Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to     its unique mechanism of action distinct from standard alkylating agents. This study assesses     its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in     comparison to fludarabine.      Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous     systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine     100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of     25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior     progression-free survival with bendamustine.   "
142213|NCT01423019|"     The purpose of this study is to determine whether subjects taking a supplement designed to     increase metabolic rate will have a positive effect on body composition (fat mass, muscle     mass, and bone density.)   "
142214|NCT01423006|"     This is a prospective pilot study. The purpose of this research study is to evaluate the     safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically     localized prostate cancer.   "
143984|NCT01399762|"     The purpose of the Endostroke Registry is to gather information on predictors of good or poor     clinical outcome following mechanical recanalization therapies for acute ischemic stroke.   "
142217|NCT01422967|"     Osteoarthritis (OA) is one of the major health problems and their prevalence has increased in     recent decades. It has been shown that OA causes negative effects on sleep and that these     changes in sleep see to be correlated with the function and physical performance of patients     with OA. However, no study to date has demonstrated the effects of sleep changes in     sensorimotor control and systemic inflammatory response in patients with OA. The objective of     this study is to assess the influence of sleep changes in sensorimotor control (postural and     neuromuscular control) and inflammatory markers (cytokines) in patients with knee OA grade I     or II. Participate in this study, 60 male volunteers, aged between 40 and 65. These     volunteers will be divided into four groups: Group 1 (n = 15): Osteoarthritis and good     quality sleep, Group 2 (n = 15): Osteoarthritis and poor quality sleep, Group 3 (n = 15):     Without good and Osteoarthritis quality of sleep, Group 4 (n = 15): Without Osteoarthritis     and poor quality of sleep. All volunteers will perform a polysomnography to detect the     presence or not of changes in sleep. Further testing on the isokinetic dynamometer to     evaluate the acceleration time, maximum isometric torque and isokinetic concentric and     eccentric maximum quadriceps muscle strength and a submaximal test to evaluate neuromuscular     control. Also there will be a test on the force platform to assess the uni-and bipedal     postural control, as well as respond to the WOMAC questionnaire that assesses the quality of     life in patients with OA. Blood will be collected for analysis of inflammatory cytokines     (TNF-alpha, IL-1alpha, IL-1beta, IL-6, IL-8, IL-12, IL-10, TGF-beta). The significance level     is 5% (p ≤ 0.05).   "
142231|NCT01422785|"     There are many different factors that cause acne. So combination treatment using different     medications that can address these different factors is commonly used to treat acne.     Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl     peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of     the medications when used together.   "
142218|NCT01422954|"     Malaria is one of the major infectious diseases in the world with a tremendous impact on the     quality of life, significantly contributing to the ongoing poverty in endemic countries. It     causes 800.000 deaths per year, the majority of which are children under the age of five. The     malaria parasite enters the human body through the skin, by the bite of an infected mosquito.     Subsequently, it invades the liver and develops and multiplies inside the hepatocytes. After     a week, the hepatocytes burst open and the parasites are released in the blood stream,     causing the clinical phase of the disease.      As a unique opportunity to study malaria immunology and efficacy of immunisation strategies,     a protocol has been developed in the past to conduct controlled human malaria infections     (CHMIs). CHMIs generally involve small groups of malaria-naïve volunteers infected via the     bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially     serious or even lethal, P. falciparum malaria can be radically cured at the earliest stages     of blood infection when risks of complications are virtually absent.      The investigators have shown previously that healthy human volunteers can be protected from a     malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito bites)     under chloroquine prophylaxis (CPS immunization). Interestingly, sterile protection in 100%     of the human CPS immunized volunteers was achieved by a relatively miniscule dose, i.e. a     total of 45 infectious mosquito bites, strikingly 20-fold more potent than the 1000 bites     needed in a model using irradiated mosquitoes. One possible explanation for this efficient     induction of protective immunity, is the immune modulating effect of chloroquine. The     investigators aim to assess this possible immune modulating effect in CPS immunization by     comparing immunization with P. falciparum sporozoites under chloroquine with immunization     under mefloquine prophylaxis, which has the same antimalarial effect, but not the immune     modulating effects known from chloroquine.   "
142219|NCT01422941|"     The objectives of this clinical research project are to demonstrate the safety and     feasibility of CAVU Medical, Inc.'s Attune Device.   "
142220|NCT01422928|"     Purpose/Goal: To investigate how long course radiation therapy (RT), both with or without     chemotherapy, affects the immune system, and to determine if acupuncture can modify these     effects in patients undergoing curative radiation therapy for gastrointestinal (GI) or     genitourinary (GU) cancers.      Clinical or Research Questions:        1. Does RT reduce immune biomarkers in treated subjects?        2. Which biomarkers are most affected by treatment?        3. Is acupuncture a feasible option to help ameliorate any biomarker effects?        4. Does RT affect subject symptoms?        5. Is acupuncture a feasible option to help ameliorate any symptom effects?   "
142221|NCT01422915|"     The investigators demonstrated that cholestyramine is an effective binding agent in vitro for     porphyrins. A few isolated case reports of treatment of individuals with a cutaneous     porphyria suggest that cholestyramine and colestipol effectively remove porphyrins.     Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower     erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).   "
142222|NCT01422902|"     This study is a multi-site, double-blind, randomized, controlled clinical trial to assess the     safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive     remediation treatment versus a computer-based control.      The investigators proposed that a computerized cognitive remediation program based upon the     principles of brain plasticity may improve information processing and thus drive clinically     significant improvements in cognitive and functional performance in individuals with     schizophrenia.   "
142223|NCT01422889|"     The purpose of this study is to compile real-world clinical outcomes data for the ION™     Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.   "
142224|NCT01422876|"     This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination     (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to     support approval by regulatory authorities.   "
142225|NCT01422863|"     The overall goal of this study is to determine the efficacy of a lifestyle intervention,     consisting of a weight loss diet and exercise on sleep apnea in older adults. The     investigators will conduct a 3-month intervention in men and women who are sedentary with     suspected sleep apnea. The investigators hypothesize that the intervention will lead to     marked improvements in sleep apnea severity and cardiovascular risk markers.   "
142226|NCT01422850|"     This study is a phase I study of a cell based prostate cancer therapy, Autologous Lymphoid     Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single     dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer patients     will receive 3 doses of the ALECSAT treatment. In this therapy specific cells from the     patient's own immune system are isolated, activated and re-administered to the patient to     boost a specific immune response against the cancer cells. The aim of the study is to show     safety and tolerability for repeated dosing of this type of therapy. It is the hypothesis     that the cells administered during the therapy will attack the tumor cells and in this way     stop or slow down the progression of disease.   "
142227|NCT01422837|"     The objective of the VIVITROL Registry is to gather real world data on opioid dependence and     to provide understanding of the health economics of opioid dependence.   "
142228|NCT01422824|"     This prospective observational study will evaluate the safety and efficacy of Mircera     (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on     haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving     once monthly Mircera according to standard of care and local labelling during 12 months of     treatment.   "
142229|NCT01422811|"     1. Background: In recent years an increasing trend in excessive lengths of stay has been          recorded at the Parma University Hospital, compared with regional mean values. Excessive          lengths of stay have been demonstrated to constitute not just an economic problem, but          also a clinical and public health issue. Since the measures taken at our institution so          far have not proven effective, the investigators carried out a literature review, which          mostly detected observational studies, restricted to the assessment of the impact of a          single intervention.        2. Objectives: This project intends to evaluate the effectiveness of a multifaceted          strategy aiming to empower clinicians on the issues associated with excessively long and          avoidable hospital stays, and enable them to identify corrective measures (according to          the principles of clinical governance).        3. Study design: cluster-randomized, parallel group, open-label, community trial        4. Methods: trained personnel will periodically record causes for excessive lengths of stay          in all participating wards using an ad hoc data collection sheet. In the wards          randomized to the experimental group, interventions aimed to clinician empowerment -          provision of reminders and periodical audits - will be implemented.        5. Expected results: A reduction in the experimental vs. the control arm unnecessary          lengths of stay is expected, although the introduced measures will also presumably lead          to improvement in the wards where they are not implemented.   "
142235|NCT01422733|"     This study will test whether longer-term suppression of adrenal function can ameliorate     androgen (male hormone) overproduction in overweight early pubertal girls with androgen     excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin     hormone (ACTH) production by 12 weeks of evening oral hydrocortisone administration will     improve androgen levels in girls with adrenal androgen overproduction. Specifically, this     intervention will improve androgen levels after adrenal stimulation testing with ACTH or     ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).   "
142236|NCT01422720|"     This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate     as adjunctive therapy for partial seizures in elderly patients.   "
142237|NCT01422707|"     Short term hydrocortisone to test whether improves excess androgen production from adrenal     gland and ovaries   "
142238|NCT01422694|"     Background:      - Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and     joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the     joints and spine. Some patients have SpA without ever developing these growths, while others     develop them after only a few years. Researchers are interested in studying people with SpA     and their relatives to determine which people are more likely to develop more severe     conditions.      Objectives:      - To identify symptoms and medical tests that can help determine whether a person with SpA is     at risk for developing more severe forms of the disease.      Eligibility:        -  Individuals of any age who have been diagnosed with SpA.        -  Healthy volunteer relatives (at least 6 years of age) of the individuals with SpA.      Design:        -  Participants will be screened with medical records and family medical histories, and          will be invited to the clinical center for the study.        -  Participants with SpA will have a physical exam and medical history, including a study          of joint movement, blood and urine tests, and questionnaires about pain and quality of          life.        -  Participants with SpA will have imaging studies, including magnetic resonance imaging          (MRI). Other samples such as skin tissue and bone marrow may also be collected for          study.        -  Healthy volunteers will provide a blood sample and cheek cell samples.        -  No treatment will be provided, although treatment options will be discussed.   "
142239|NCT01422681|"     The minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory     load during chronic obstructive pulmonary disease (COPD) exacerbation, reducing the need to     advance the respiratory care toward invasive mechanical ventilation in patients refractory to     non-invasive ventilatory support (NIV), or decreasing the need of ventilatory support in     patients already invasively ventilated, thereby accelerating the weaning process.      The investigators intend to perform a multi-center experimental non randomized single arm     prospective study to investigate the efficacy of the Decap Smart in reducing the intubation     rate or the duration of invasive mechanical ventilation in patients with COPD treated either     with NIV or invasive mechanical ventilation (IMV) for severe respiratory failure and     hypercapnia. The results of the study will be compared to the data available in the     literature.   "
142240|NCT01422668|"     The aim of this study was to evaluate the composition of Khalas, a very common type of dates     used in the UAE and to determine the effects of drinking Arabic coffee on the results of GI     tests in both healthy and diabetic subjects.   "
142254|NCT01422486|"     Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat     (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell     (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome     (MDS).   "
142241|NCT01422655|"     Objective: To assess the accuracy of transcutaneous bilirubin (TcB) measurements in neonates,     in relation to gestational age (GA), time (postnatal hour) and site (forehead, sternum, knee)     of measurements.      Hypothesis: Using (or combining) different sites for TcB determination might improve the     accuracy of TcB in relation to the time of measurement and the GA of the neonate.      Methods: The study will include neonates >32 weeks' gestation cared for in the well-baby     nursery and NICU of the University Hospital of Patras, from September to December 2011. Data     such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO     group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight,     postnatal medications and interventions, type and volume of feeding, and extension of     jaundice, will be collected.      TcB measurements will be performed using the BiliCheck bilirubinometer (according to the     standard protocol) at 3 different sites: forehead, sternum and knee. Total serum bilirubin     (TSB) values will be obtained using the heel stick technique, and measurements will be     performed by a direct spectrophotometric device (Unistat bilirubinometer, Richert, Depew,     NY). The accuracy of the device has been validated previously. TSB measurements will be     performed within 5 minutes of the TcB measurements.      At each occasion TcB measurements (3), the corresponding TSB value, the time of measurement     (postnatal hours), and the actual weight will be noted.      Statistics: The agreement between TcB and TSB values will be assessed using the Bland-Altman     % method. The independent and joint effects of GA and time of measurement on bias will be     evaluated by multivariate regression analysis.   "
142242|NCT01422642|"     The purpose of this study is to determine if there are any clinical or ROM differences in     total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.   "
142243|NCT01422629|"     This study is a multicentre, open, uncontrolled trial for the observation of histological     changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).      This study will be conducted in France in 20 patients with breast fibroadenoma with     indication for a surgical resection. The patient will receive an HIFU treatment and 6 months     after treatment, the need of the surgery is evaluated.   "
142273|NCT01422239|"     The purpose of this study is to develop and pilot test a smoking cessation counseling that     focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and     negative affect, loss of enjoyment).      Aim 1: To develop the risk-based smoking cessation intervention.      Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks     of quitting is feasible to administer and acceptable to adult women who want to quit smoking.      Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment     in comparison to standard smoking counseling. It is expected that women who receive     risk-based counseling will show better quit rates and a longer time to relapse than women who     receive standard treatment.   "
142244|NCT01422616|"     ENCHANTED is an independent, investigator initiated, international collaborative,     quasi-factorial randomised controlled trial involving a package of 2 linked comparative     randomised treatment arms, which aims to address 4 key questions in patients eligible for     thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg)     intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent     benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP)     lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline     recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg)     intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of     symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering     to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?      The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication     of the results in May 2016. The BP intensity arm of the study is ongoing.   "
142245|NCT01422603|"     This study has been designed to investigate the safety and feasibility of using a     chemotherapy drug, Clofarabine, to reduce the disease burden before a donor transplant, in     patients with high risk Acute Myeloid Leukaemia or Myelodysplasia (MDS). In this study     Clofarabine chemotherapy will be given a few days before a reduced or full intensity donor     stem cell transplant and without waiting for normal blood counts to recover. It is hoped that     this approach may improve the outcome for patients with high risk AML and MDS after their     transplant.   "
142246|NCT01422590|"     1. Explore pharmacodynamics             -  glucose             -  insulin             -  C-peptide             -  glucagon             -  intact GLP-1             -  DPP-4 activity             -  CGMS (continuous glucose monitoring system)        2. Assess Safety             -  adverse events             -  clinical laboratory test             -  physical examination   "
142247|NCT01422577|"     Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon     cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve the     detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to     compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis     of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in     the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology     that enables endoscopists to obtain better images in suboptimal conditions. The study     proposes to compare the performance of colonoscopy using either white light or bright NBI in     subjects undergoing screening colonoscopy in search for colon adenomas.      Purpose      To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average     risk subjects undergoing screening colonoscopy.   "
142248|NCT01422564|"     This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to     the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a     primary cementless total hip replacement.   "
142249|NCT01422551|"     The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress     management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial     adaptation and physiological adaptation in women being treated for stage I-III breast cancer.   "
142250|NCT01422538|"     This clinical trial will evaluate clinical outcomes associated with the non-invasive     Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.   "
142251|NCT01422525|"     At present, trabeculectomy is the most common performed and effective surgical method of     filtration surgery for patients with medically uncontrolled glaucoma.      The aim of this prospective observational case study is to determine changes of the     peripapillary retinal nerve fiber layer thickness using spectral domain optical coherence     tomography in patients with glaucoma after surgical reduction of intraocular pressure.   "
142252|NCT01422512|"     This study will evaluate safety and immunogenicity of surface, antigen, inactivated,     influenza vaccine produced in mammalian cell culture when administered to adult and elderly     subject.   "
142253|NCT01422499|"     The aim of this study is to define a dose recommendation of vorinostat in pediatric oncology,     to determine pharmacokinetics of vorinostat in children, determine response rates, safety and     feasibility.   "
142255|NCT01422473|"     The purpose of this study is to examine the advantages and disadvantages of using the EnSeal     device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques.      It is hypothesized that the use of the Enseal device will demonstrate an improvement a     patient's overall experience through less postoperative bleeding and pain, decreased time for     wound healing, and a faster return to work.   "
142256|NCT01422460|"     The investigators will try to find any efficacy of platelet rich plasma injection for the     treatment of osteoarthritis (OA) in the subtalar joint. Autologous platelet-secreted growth     factors (GFs) may have therapeutic effects in OA capsular joints via multiple mechanisms. The     investigators aim is to examine the effect of a platelet-derived preparation rich in growth     factors(PRGFs) in OA of the subtalar joint, using parameters of pain, function, quality of     life and safety.   "
142257|NCT01422447|"     The purpose of this research is to establish a suitable community-based model for Chinese     culture,to improve the community recognition of common mental disorders,as well as its     treatment and control.   "
142258|NCT01422434|"     The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily     with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily     in Japanese subjects with psoriasis vulgaris.   "
142259|NCT01422421|"     The purpose of this study is to determine whether intensive blood pressure and low density     lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in     Japanese diabetic patients with coronary artery disease and history of acute coronary     syndrome.   "
142260|NCT01422408|"     This phase II trial studies how well giving fluocinonide cream works in treating symptoms of     vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing     hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual     intercourse in patients undergoing hormone therapy.   "
142976|NCT01412957|"     The purpose of this study is to evaluate the benefit of panitumumab in addition to best     supportive care compared to best supportive care alone in patients with chemorefractory     wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.   "
142261|NCT01422395|"     Indications for oocyte (egg) vitrification (fast freezing) include the preservation of     reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or     surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows     patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical     dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation     could allow women to delay childbearing if they want or need to. Until recently, conventional     cryopreservation protocols have remained too inefficient for practical application in an     infertility center. Very little is known about the effects of vitrification on oocytes and     subsequent embryo development, especially using the sibling model (group of oocytes from the     same cohort of ovarian follicles within patient). The purpose of this study is to examine the     effect of oocyte vitrification on fertilization rates, embryo quality and development.   "
142262|NCT01422382|"     This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug     interaction study.   "
142263|NCT01422369|"     This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug     interaction study.   "
142264|NCT01422356|"     Studies indicate that men who have sex with men (MSM) have a high prevalence of anogenital     Human papillomavirus (HPV) infection and increased risk for HPV related anogenital lesions     including anogenital warts, anal intraepithelial neoplasia (the abnormal proliferation of     cells) and anal cancer. Currently in Australia, HPV vaccine for men is not covered by     programs. This study will explore the prevalence of HPV infection and sexual behaviours     associated with varying prevalence of HPV infection.      The investigators will survey 200 MSM aged 16-20 years who just started their sexual life.     The investigators will use a questionnaire to collect information of socio-demographic     characteristics, lifetime sexual experience, recent sexual experience, the most recent sexual     contact, sexually transmitted infections (STIs)/HIV history and testing history, HPV     knowledge and attitude, smoking/alcohol/drug/circumcision. The investigators will also     collect oral, penile and anal samples as well as blood samples to test for HPV DNA and     antibody.      The study will include four visits in the 12-month period. In each visit, participants will     be asked to fill a questionnaire and provide oral, penile and anal samples as well as blood     samples.   "
142265|NCT01422343|"     Although microparticles have been well-documented as mediators of inflammation and     coagulation in various cardio-vascular disease events, it is currently not known how     Percutaneous Transluminal Angioplasty (PTA) for peripheral arterial disease influences     microparticle numbers, phenotype and distribution pre- and post interventionally and how they     are related to or affect the incidence of early re-stenosis - or if indeed they may be used     to predict patients at risk of early re-stenosis.   "
142266|NCT01422330|"     The purpose of this study is to learn more about the safety and tolerability of etravirine.     Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has     shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains     resistant to other non-nucleotide agents.   "
142267|NCT01422317|"     The object of this study was to evaluate the effect of a high-dose ethylester concentrate of     of n-3 fatty acids administered early after an acute myocardial infarction on subsequent     cardiac events and serum lipids.The second purpose of this study was to assess the impact of     high-dose n-3 fatty acids on several markers of coagulation, inflammation, endothelial     dysfunction and lipid peroxidation. Re-investigation was intended after a prolonged     wash-out-period.   "
142268|NCT01422304|"     This study will assess the effect of reversal of neuromuscular blockade with sugammadex     compared with reversal according to usual care (neostigmine or spontaneous reversal) on the     incidence of post-surgical bleeding events and on coagulation parameters in participants     undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular     blockage induced by rocuronium or vecuronium.   "
142269|NCT01422291|"     This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous     single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.   "
142312|NCT01421732|"     A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho     Chi Minh City and Tien Giang province, Viet Nam.      Different blood tests are compared at the early stages of dengue fever onset in their ability     to accurately and specifically detect children whose dengue will progress to severe disease.   "
142270|NCT01422278|"     Evaluating the effects in functional status after three weeks of cognitive - and behavioural     rehabilitation on patients with gait disorder. The patients are followed up as after 1 and 12     months to study if any improvement is still present. The patients are being recruited from     neurological units. The intervention is explanation of symptoms, positive reinforcement of     normal behaviour and absence reinforcement of dysfunctional behaviour. In addition the study     aims at describing typical gait patterns at patients with gait disorder by using     biomechanical measurements (EKG).   "
142271|NCT01422265|"     This multicenter, observational, prospective study will include approximately 20 US-based     centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary     peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after     first-line platinum-based chemotherapy (first recurrence). Patients who have completed     second-line chemotherapy and are currently in observation or undergoing bevacizumab     maintenance treatment will be eligible to participate in the study.   "
142272|NCT01422252|"     The objective of this study is to evaluate the evolution 6 months after a fall occurring at     home in people over 75 equipped or non-equipped with a precocious detection device. The     possibility to establish a relation between the alert emitted by the device, the time     separating the fall from the arrival at hospital and the potential consequences for the     persons will be analyzed with the greatest accuracy. Besides, the sequences of intervention     of the different operators will be described with precision. 200 persons living at home in     the ESSONNE(France)and having fallen at least one time during the previous 3 months will be     included in the study and two groups of 100 will be constituted randomly after having signed     a written consent. Of the 2 groups, one will be constituted with persons equipped with a     precocious fall detection device named Vigi'Fall® , the second being non-equipped. After a     first visit checking that the inclusion criteria are abide by and the installation of the     device in the persons designated randomly for being equipped, a second visit will be carried     out after 10 months in order to know the evolution, i.e. if the persons are still alive,     living at home or having left for admission in an institution (hospital, nursing home,     retirement home...). By a detailed comparison between the 2 groups, it will be possible to     evaluate the potential interest of having been equipped or non-equipped with a precocious     fall detection device. Hence, a change in practices may lead to a prevision of elderly     persons likely to benefit of a precocious detection device and to the development of     prevention in hospital geriatric departments, geriatric care networks, emergency departments     and local services for the elderly and disabled. Another possible gain of the study is to     sensitize the medical, paramedical and social teams to the usefulness of precocious detection     devices in elderly subjects at risk for falls.   "
142274|NCT01422226|"     Over the last several years, more and more women are choosing intrauterine contraception     (IUDs) to meet their birth control needs. The effectiveness of IUDs is very similar to tubal     sterilization, with an overall unintended pregnancy rate of less than 1% in the first year,     and lower failure rates in subsequent years. Intrauterine contraception has many attributes     besides its effectiveness; it is easily reversible, has a low side-effect profile, and     provides a long-term solution for contraception (10 years for the copper T380 and 5 years for     the levonorgestrel IUD). In addition, using an IUD for birth control requires little on-going     effort by the woman to be effective and offers immediate return to fertility with its     removal.      The biggest increase in users is among nulliparous women (women who have not had children),     due to increased awareness of the safety of modern IUDs in this population, and the many     benefits of the method. In fact, The copper IUD (Paragard) is now FDA approved for use in     nulliparous women, and the American College of Obstetricians and Gynecologists supports the     use of both copper and levonorgestrel IUDs in nulliparous women. The cervix of a nulliparous     woman has a smaller diameter which can lead to more difficult and uncomfortable IUD     insertions. Many providers avoid offering IUDs to nulliparas because of fears that the     procedure will be more difficult, and may require cervical dilation, placement of a     paracervical nerve block, or placement under ultrasound guidance, none of which are standard     for parous women. The medication misoprostol is a prostaglandin E1 analog. Because of     misoprostol's known ability to cause cervical dilation, some family planning providers give     their nulliparous patients a dose of this drug prior to IUD insertion. Misoprostol is     commonly used to dilate the cervix for similar procedures as in first trimester abortions,     hysteroscopy and endometrial biopsies. Its efficacy in cervical priming for IUD insertion is     unknown, and some concern exists that uterine contractions caused by the drug may lead to     device expulsion or displacement.      In this study, the investigators propose to ask nulliparous women who have undergone     contraceptive counseling and decided to use an IUD for birth control to be randomized to the     use of misoprostol or placebo prior to their scheduled IUD placement.   "
142275|NCT01422213|"     Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD     primarily involves mood disturbances, patients also usually present alterations in cognitive     function (attention, memory, executive functioning and psychomotor speed). Even though     antidepressants are suggested in the literature to potentially improve cognitive dysfunction     in patients with MDD to some degree, there is a lack of adequate and well-controlled studies     to investigate this effect. This study will evaluate the efficacy, safety and tolerability of     a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients     with MDD.   "
142276|NCT01422200|"     The purpose of the study is to compare the immune response of two different injection methods     (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among     patients with neuromuscular conditions who have significant muscle degeneration. This     research study hypothesizes that the subcutaneous route of vaccine administration, as     compared to the intramuscular route, may confer at least comparable, or possibly better,     immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive     Care Center will be recruited to participate in this study lasting approximately one to two     months with two clinic visits and one follow-up telephone call. Immunogenicity will be     assessed by comparing hemagglutination inhibition (HAI) antibody titers obtained pre- and     post-vaccination.   "
142277|NCT01422187|"     This is a multi-center trial to further extend the assessment of the safety and efficacy of     taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled     in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of     taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months     or until taliglucerase alfa is commercially available to the subject at the discretion of the     Sponsor.   "
142349|NCT01421251|"     Many people worldwide received the monovalent adjuvanted H1N1 vaccine. However, very little     is known about the safety of the vaccine, particularly beyond the first few weeks after     vaccination. This study will combine data from a well-established immunization registry in     Manitoba with data from hospitalization and physician records, to examine the safety of the     vaccine in the six month period post-vaccination. Studies on vaccine safety are important as     the public's perception of the safety of a vaccine has a major role in its uptake.   "
142278|NCT01422174|"     INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at     industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as     extended as expected, with respect to indications for primary prevention defibrillator     implantation, following MADIT II and MUSTT criteria, especially at Latin American countries.      OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading     primary prevention by the means of clinical evidence on real risk of death in this group of     patients.      REGISTRY DESIGN:        -  retrospective (at stage 1); prospective (at stage 2)        -  multi-center (minimum 25-30 centres)        -  international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela)        -  non randomized.        -  Sample size: at screening about 12.500 patients and 962 patients at treatment stage      REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT     (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).   "
142279|NCT01422161|"     The purpose of this study is to determine whether injections of botulinum toxin (commonly     known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles     controlling the hand, will lead to improved use of the hand when compared to injections of     placebo (a substance that looks similar to the study drug but contains no active study     medication).   "
142280|NCT01422148|"     Postoperative atrial fibrillation (POAF) is a common complication after heart surgery.      Amiodarone is the drug of choice to treat POAF. Inflammation is considered one of underlying     factor for POAF. Minocycline is an antibiotic with anti-inflammatory properties.   "
142281|NCT01422135|"     This is a pharmacokinetics and safety study over 3 weekly applications.   "
142282|NCT01422122|"     There is a gap in knowledge regarding the effects of Vitamin D supplementation on periodontal     status in pregnant wome. The investigators aim to evaluate the potential benefit, if any of     vitamin D supplementation during pregnancy on periodontal disease and relevant outcomes     including burden of infections and prematurity rates.      the investigators hypothesize that        1. Vitamin D supplementation during pregnancy improves the periodontal health.        2. There is an association between inflammatory biomarkers and periodontal health of          pregnant females.        3. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates          and birth weight   "
142283|NCT01422109|"     The objective of this study is to compare pharmacokinetics after single oral administration     of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by     Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in     healthy male volunteers.   "
142977|NCT01412944|"     The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous     (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial     responders to secukinumab.   "
142284|NCT01422096|"     This study will test whether short-term suppression of ovarian function can ameliorate     androgen (male hormone) overproduction in overweight girls with androgen excess. The     investigators hypothesize that one dose of depot leuprolide agonist administration will     improve androgen levels in girls with ovarian androgen overproduction. Specifically, this     intervention will improve androgen levels after ovarian stimulation testing with recombinant     human chorionic gonadotropin (rhCG).   "
142285|NCT01422083|"     A loss of mobility in the shoulder in direction of internal rotation is associated with     shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It     is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder     tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral     internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes     this population interesting to investigate. This study wants to look at shoulders of overhead     athletes with GIRD and measure the size of the subacromial space. After this, the athletes     will be instructed to perform a home stretching program and at the end the effect of this on     mobility and the size of the subacromial space will be measured.60 athletes will be recruited     and randomly allocated to the control group and the stretching group. Before they start     stretching, subacromial space size will be measured by use of ultrasound. This is a safe and     non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This     also is safe and non-invasive. Patients will be instructed a stretching exercise, which they     will be performing at home once a day during 6 weeks. At the end all outcome measures will be     reassessed.   "
142286|NCT01422070|"     The starting point of ELOISE is the significant number of Intensive Care Unit (ICU) survivors     who die after the transfer to ward. This mortality rate nullifies the sophisticated     diagnostics and the life-support therapies adopted in the ICU.      The inadequate care available at the destination ward has been suggested as one of the     reasons to explain the bad outcome of some ICU survivors, but most hospitals do not have     enough ICU beds to prolong the ICU stay until the patient has fully recovered. Therefore,     Inter Mediate Care Units (IMCU) with levels of nursing staff and costs lower than ICU but     higher than wards have been proposed to facilitate discharges of ICU patients. Unfortunately     the literature does provide evidence of efficacy of IMCU.      The primary aim of the study is to assess whether the patients admitted to ICUs with     availability of IMCU have lower hospital mortality than those admitted to the ICU without     availability of IMCU.      Secondary aims are as follows:        1. To compare Lengths Of ICU and Hospital Stay (LOIS and LOHS, respectively) of patients          admitted to ICUs with or without availability of IMCU.        2. To assess the influence of IMCU on the rate of ICU readmissions.        3. To compare the hospital survival of patients discharged to IMCU and general ward (in          hospital with or without availability of IMCU) adjusted for severity of illness and          nursing workload at ICU discharge. This last aim will require a larger sample size (more          than 10,000), but we hope to collect such a sample.   "
142287|NCT01422057|"     The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a     prognostic marker in type-2 diabetics with ischemic heart disease   "
142288|NCT01422044|"     The purpose of this study is to test the prognostic value of autonomic markers in patients     with aortic stenosis.   "
142383|NCT01420809|"     This post-marketing surveillance study was designed to collect and assess the information on     proper use of fondaparinux injection, such as the safety and efficacy under actual use     conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of     developing venous thromboembolism.      (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)   "
142289|NCT01422031|"     The aim of this study was to find out the utilization rate and pattern of primary health care     services, and the process and outcomes of primary care consultations of the general     population in Hong Kong, and whether having a family doctor would make any difference.      The study objectives were to determine        1. the rates and pattern of utilization of different primary health care services and          self-care        2. Patient self-reported outcomes (global rating on change in health, satisfaction and          patient enablement) of primary care consultations;        3. the process of care in consultations including drug and non-drug managements,          investigations, preventive care and referrals;        4. the effect of having a regular family doctor on service utilization rate and pattern,          health promotion practice, and process and outcomes of primary care consultations.   "
142290|NCT01422018|"     Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard     exudates secondary to diabetic retinopathy.      Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive     patients showing focal edema with hard exudates secondary to diabetic retinopathy which are     not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).   "
142291|NCT01422005|"     The purpose of this study is to examine if practicing joint movements using specially     designed devices can help in the recovery of muscle function in the arm/hand after a stroke.     Subjects may qualify for participation in this study because they had a stroke and have had     difficulty using their affected arm/hand ever since.   "
142292|NCT01421992|"     The purpose of this study is to determine whether methylphenidate is effective in the     treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).   "
142293|NCT01421979|"     The aim of this study is to examine the safety and the effects of EDs at high doses, either     alone or in combination with other risk factors such as alcohol intake, physical exercise and     sleep deprivation, on cardiovascular markers and subjective health.   "
142294|NCT01421966|"     Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus.     These ulcers are reported to be the leading cause of hospitalization among people with     diabetes.      The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity     ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing     activated homologous white blood cells prepared from donated healthy whole blood. A total of     280 patients will be randomized to receive either CureXcell® or sham.   "
142643|NCT01417390|"     The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus     concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with     locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of     induction chemotherapy using gemcitabine and cisplatin in NPC patients.   "
142295|NCT01421953|"     Computed tomography (CT) images, used for radiotherapy planning, are often caught out in lung     target volumes delineation because of their inability to differentiate between neoplasia,     inflammation and atelectasia. Positron Emission Tomography (PET) is a new functional imaging     modality and is currently used in the diagnosis and the staging of lung cancers. The aim of     this study is to evaluate the impact of 4D 18F-FDG-PET-CT on radiotherapy planning for lung     cancers.   "
142296|NCT01421940|"     Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to     the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The     purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical     co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal     excision.   "
142297|NCT01421927|"     Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a     controversial topic because of a high risk of relapse and a significant transplant-related     mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now     performed after reduced-intensity conditioning regimens. In these conditions, TRM usually     range from 10 to 20%. However, reducing the intensity of the conditioning invariably     increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies     to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and     evaluated.   "
142298|NCT01421914|"     This is a study to calculate the minimum effective volume of bupivacaine 0,5% with     epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the     patients (MEV50).   "
142299|NCT01421901|"     The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the     highest incidence in the second decades . The aetiology of AA is still poor understood: the     commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix     barrier and thus wall perforation and/or abscess formation1. However some studies suggest     that no-complicate and complicate appendicitis are different entities allowing a different     treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic     treatment compared to surgery in a population with high probability to suffer of 1st episode     of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment     compared to surgery in a population with high probability to suffer of 1st episode of AA.   "
142300|NCT01421888|"     Objectives:        -  To study nutrition and immune system problems in people with urea cycle disorders.        -  To study how people with urea cycle disorders and healthy volunteers respond to standard          flu and/or hepatitis A vaccines.        -  To compare differences in nutrition and immune systems of people with urea cycle          disorders with that of healthy volunteers.      Eligibility:        -  Healthy males and females at least 2 years of age who are able to travel to the National          Institutes of Health hospital in Bethesda, MD        -  Males and females at least 2 years of age who have a urea cycle disorder and are able to          travel to the National Institutes of Health hospital in Bethesda, MD.      Design:      For Patients with urea cycle disorder:        -  Participants will spend 2 to 3 days in the National Institutes of Health hospital for          the following tests:        -  A physical exam and review of medical history        -  Food log for 3 days before the start of the study        -  Blood tests        -  24-hour urine collection        -  Resting metabolism test        -  DEXA scan imaging study of bones and body fat        -  Participants who are old enough to do certain tasks by themselves (like dressing and          eating) can choose to have the following extra tests:        -  24-hour metabolic room measurements        -  BodPod(Registered Trademark) study to measure bones and body fat        -  Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the          study and will be monitored to check for possible side effects.        -  Participants will return within 1 to 3 months for follow-up tests/immunizations.      For Healthy Volunteers:        -  Participants will be seen at the outpatient clinics at the National Institutes of Health          hospital for up to 2 visits for the following:        -  Review food log completed 3 days before the start of the study        -  Blood tests        -  Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the          study and will be monitored to check for possible side effects.        -  Participants will return within 1 to 3 months for follow-up tests/immunizations.        -  Review of second food log completed 3 days before second outpatient visit   "
142301|NCT01421875|"     RATIONALE: Studying blood samples from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers related to chemotherapy resistance and     outcomes in samples from older patients with acute myeloid leukemia.   "
142302|NCT01421862|"     RATIONALE: Studying samples of bone marrow and blood from patients with cancer who failed     treatment may help doctors learn more about changes that occur in DNA and identify biomarkers     related to cancer resistance. It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial studies biomarkers in samples from adult patients with acute     myeloid leukemia who failed standard-of-care treatment.   "
142303|NCT01421849|"     Study hypothesis: that there would be no difference in patient satisfaction among     institutionalised older people before and after treatment with a mandibular single     implant-retained overdenture.      In a preliminary phase, a new denture is made or the old denture is adapted to provide a     well-fitting denture.      Eight weeks after insertion of the new denture a single implant is placed in the centre of     the mandibula. If the level of primary stability is sufficient to enable the implant to     resist micromovement, the implant is immediately loaded . If not, the implant is loaded after     6 to 12 weeks. Primary stability is assessed by the final seating torque and by the     clinician's interpretation and tactile sense of primary stability. Before, during and after     the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item     questionnaire and a clinical examination.   "
142304|NCT01421836|"     1. Purpose of the study           -To compare stent patency and complication rate between endoscopic ultrasound (EUS)          guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided          stent insertion for malignant biliary obstruction        2. Subjects of the study           -Patients who have biliary obstruction owing to malignant tumors        3. Methods of the study             -  Prospective randomized controlled study             -  Patients were enrolled randomly in two groups, EUS guided stent insertion group or               ERCP guided stent insertion group             -  Patients will get assigned procedure (EUS guided stent insertion or ERCP guided               stent insertion)for decompression of malignant biliary obstruction             -  After the procedure, regular follow up, blood test,and imaging test will be done to               check sufficient biliary decompression,stent patency and complications.   "
142305|NCT01421823|"     The purpose of this study is to assess the effect and safety of alpha agonist ointment on     fecal incontinence severity in patients with idiopathic fecal incontinence.   "
142306|NCT01421810|"     Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body     hair, irregular menstrual periods, or no menstrual periods excess body weight, and     infertility. It also results in elevated androgen levels such as testosterone. In women with     PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown     whether the ovaries are fully active during early puberty. The purpose of this study is to     determine how the ovaries contribute to the production of male hormones in the body during     different stages of puberty, so that it can be better understood why some females have excess     androgens.   "
142307|NCT01421797|"     Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much     facial and body hair, and weight gain. Women with PCOS also have a hard time becoming     pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as     adults. Some girls with high levels of male hormone will develop normal hormone levels as     they grow up, but most girls continue to have high levels of male hormone as adults. The     purpose of this study is to understand where the male and female hormones come from in girls     as they get older. The investigators think the adrenal gland, makes most of the hormones in     young girls and that the ovary and the adrenal gland make these hormones in older girls. The     investigators would like to find out whether an overactive adrenal gland makes these hormones     higher in girls who are overweight, compared to those who are not overweight.   "
142308|NCT01421784|"     In this study, the researchers investigate the feasibility of using rapid cine MR imaging to     provide both offline and online soft-tissue-based image guidance. Such images will provide a     significantly more complete picture of the spatial and temporal changes in thoracic anatomy.     This more complete information will lay the groundwork for better radiotherapy planning and     dose delivery in the presence of respiratory motion.   "
142309|NCT01421771|"     Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although     studies in the general population have demonstrated a continuous reduction in CV risk with     each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in     hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension     may have decreased mortality compared to those with normal blood pressure (BP). The     investigators recently reported that among HD patients, those with routine pre-dialysis BP     values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm     Hg) had increased mortality compared to patients with mild to moderate hypertension. However,     these observational studies included untreated patients in whom low or normal BP may reflect     significant cardiac disease or other comorbid conditions. In the setting of reduced vascular     compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or     cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or     beneficial. A well-designed randomized control trial (RCT) is needed to answer this important     question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to     assess feasibility and inform the design of the former. The investigators propose to conduct     a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of     treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.   "
142310|NCT01421758|"     This study was designed to determine whether participation in an online social network     intervention increases perceived social support for physical activity versus a minimal     education control group by conducting a randomized controlled trial with 140 female     undergraduate students. The investigators hypothesize that participants in the physical     activity centered online social network intervention group will have greater increases in     perceived social support for physical activity compared to minimal web based physical     activity education controls.   "
142311|NCT01421745|"     There are three purposes for this study:      I. to establish the construct validity (via factor analysis) of the Inventory for Assessing     the Process of Cultural Competence Among Healthcare Professionals - Student Version     (IAPCC-SV) II. to determine the responsiveness of the IAPCC-SV III. to investigate     demographic predictor variables of the IAPCC-SV      It is hypothesized that:      I. the variables will load on only one component, with each component being represented by a     number of strongly loaded variables II. the IAPCC-SV will demonstrate responsiveness,     evidenced by significantly higher post-module IAPCC-SV scores of the experimental group when     compared to the control group III. the cultural composite score and race will be significant     predictors of IAPCC-SV score   "
142412|NCT01420432|"     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for     the therapy of Ankylosing spondylitis (AS)   "
142313|NCT01421719|"     The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of     frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur     at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer from     this disease, they are also prone to development of benign prostatic hyperplasia (BPH) and     consequent associated lower urinary tract dysfunction. Similarly the over 65-year age group     develop spontaneous overactive bladder up to a prevalence of 30% of both men and women. The     urologic disorder is exceedingly devastating in reducing the quality of life in these     individuals due to the lower urinary tract symptoms and ultimate urinary incontinence in a     high proportion of patients.      While attempts at pharmacologic treatment are partially satisfactory many patients are     intolerant of oral drugs.      Botulinum-A neurotoxin (BTX-A) has been shown in pilot trials to be quite effective in     reducing overactive bladder symptoms and is specifically beneficial for a wide-variety of     neurogenic bladder causes of over activity . The treatment procedure of injecting the     detrusor muscle of the bladder with BTX-A is quite simple, does not impose significant risks     to the patient, and can be performed as an office urologic procedure.      This pilot clinical trial intends to demonstrate the safety and efficacy of low-dose Botox-A     injections into the bladder to improve urinary symptoms in 20 patients.   "
142314|NCT01421706|"     Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy     subjects   "
142315|NCT01421693|"     The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three     hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned     to one of the two treatments by chance and followed for 6 months. The two treatment groups     will be compared to see which treatment is more likely to make the patient better.   "
142316|NCT01421680|"     The objective of this study is to evaluate the effect of a perioperative nutrition strategy     using oral nutritional supplements (ONS) on postoperative complications and improvement in     body weight in malnourished patients who underwent gastrectomy.   "
142445|NCT01419990|"     The purpose of the study is to evaluate the safety and tolerability of multiple ascending     oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.      During the course of the study, the amount of GLPG0634 present in the blood     (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related     parameters in the blood (pharmacodynamics) will be characterized.   "
142317|NCT01421667|"     This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and     safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin     lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab     vedotin in combination with rituximab in patients with relapsed or refractory diffuse large     B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression     and response in DLBCL (Part C).   "
142318|NCT01421654|"     The purpose of the study is to evaluate if using the Acclimate feature at the beginning of     Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least     as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated     with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and     respiratory events.   "
142319|NCT01421641|"     The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine     injection versus topical lidocaine gel on the pain experienced by patients undergoing     tenaculum application to the cervix during office gynecologic procedures. This study will     also evaluate how satisfied women are with the method of pain control used.      The researchers hypothesize that:        1. There is less pain perceived by patients undergoing placement of a tenaculum on the          cervix when a lidocaine injection is used compared to a topical lidocaine gel.        2. Patients are more satisfied with pain control during the overall experience of          undergoing tenaculum placement on the cervix when a lidocaine injection is used compared          to a topical lidocaine gel.   "
142320|NCT01421628|"     Ageing is related to a decrease in physical fitness, disability and age related symptoms like     nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity     and mobility to increase physical fitness and decrease disability and nocturnal cramp in     older adults.   "
142321|NCT01421615|"     The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial     vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the     patients with durative positive result. It is assumed that the living preparation of     lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment     can increase the response rate and improve pregnancy outcomes in the durative BV positive     patients comparing with one-course one.   "
142322|NCT01421602|"     This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal     repair is feasible in the Philippine setting. It will result in a comparable recurrence rate     as published for the traditional Lichtenstein approach.   "
142323|NCT01421589|"     Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in     obesity is associated with increased cardiovascular disease risk. However, it is not yet     known how reduced GH increases cardiovascular disease risk in obesity. The investigators     hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the     investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH     will improve mitochondrial function and that this improvement in mitochondrial function will     contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The     investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH     secretion using magnetic resonance spectroscopy and muscle biopsies before and after     treatment with GH.   "
142324|NCT01421576|"     A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect     on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male     volunteers.   "
142325|NCT01421563|"     The purpose of this study is compare the safety and pharmacokinetic characteristics of     DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after     oral administration in healthy male volunteers.   "
142393|NCT01420679|"     The purpose of this study is to see if pralatrexate extends response and survival following     CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone)     and if pralatrexate improves response in patients with partial response following CHOP-based     chemotherapy. Patients will either receive pralatrexate or be under observation. All patients     will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their     disease and health.   "
142394|NCT01420666|"     The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are     greater than acetaminophen, ibuprofen or placebo in patients who have painful osteoarthritis     of the hip or knee.   "
142326|NCT01421550|"     The purpose of the present study is to investigate whether or not to perform elective     surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are     no other randomized controlled trials in this area. The optimal management in patients with     umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical     opinion is that umbilical hernias in patients with ascites should not be corrected because of     the supposedly high operative risks and high recurrence rates. Conservative treatment,     however, can have severe complications resulting in emergency repair. Such operations carry a     higher risk of complications than elective operations, particularly in this group of     patients. Prospective and retrospective series showed us that elective hernia repair in this     specific patient group is safe without major complications or high recurrence rates.      The aim of this study is to asses the optimal timing of correction of umbilical hernia in     patients with liver cirrhosis and ascites.   "
142371|NCT01420965|"     Background:      - Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a     person with prostate cancer and treats them in the laboratory. Then it returns the cells to     the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the     drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide     will also be given, either before or after the cells are collected at the start of the     treatment.      Objectives:      - To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate     cancer.      Eligibility:      - Men at least 18 years of age who have advanced prostate cancer.      Design:        -  Participants will be screened with a medical history, physical exam, blood and urine          tests, and imaging studies.        -  This study has two parts, with different participants in each part. All participants          will be monitored with frequent blood tests and imaging studies.        -  Part I:        -  Participants will provide cells for the Sipuleucel-T treatment three times. The first          time will be 3 days before the chemotherapy. The second time will be 10 days after          chemotherapy. The third time will be 24 days after chemotherapy.        -  Participants will have one dose of cyclophosphamide the day before the first dose of          Sipuleucel-T.        -  Participants will have Sipuleucel-T about 3 days after each cell donation.        -  Part II:        -  Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or          given with both cyclophosphamide and CT-011.        -  Participants will provide cells for the Sipuleucel-T treatment three times, as in Part          I.        -  Participants will have Sipuleucel-T about 3 days after each cell donation, and will          receive treatment with the other drugs as directed by the study doctors.   "
142475|NCT01419587|"     This study investigates if using a very low carbohydrate diet during combined chemotherapy     and radiation therapy is safe and if it can be tolerated by lung cancer patients.   "
142327|NCT01421537|"     OVERVIEW:        -  Thromboembolisms represent a serious and feared complication in hospitalized patients.        -  Several factors make the ICU patient population at increased risk of venous          thromboembolism.        -  A high incidence of thromboembolic events is starting to emerge from recent medical          literature in the burn patient.        -  Actual guidelines for thromboprophylaxis in burn care patients are based on multiple          non-burn patient trials.        -  Burn patient physiology is radically different than that of general ward hospitalized          patients        -  Since the actual chemical thromboprophylaxis have not been evaluated in the burn          patient, it is of interest to assess their efficacy in patients with severe burns.        -  Hence, the pharmacokinetic characterization of heparins (a well accepted mode of          thromboprophylaxis) in burn patients could guide future quality of care for this          subclass of patients.      Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight     heparins in the burn patients do not correlate with levels described to prevent     thromboembolic events in the general hospitalized population.      The investigators aim to:        1. To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins          (enoxaparin), with anti-Xa levels in severely burned patients receiving          thromboprophylaxis.        2. To determine the correlation between antithrombotic activity of heparins and the          different metabolic phases of the thermally injured patient.   "
142328|NCT01421524|"     The main purpose of this first in human study with CC-122 is to assess the safety and action     of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced     tumors unresponsive to standard therapies and to determine the appropriate dosing level and     regimen for later-stage clinical trials.   "
142329|NCT01421511|"     This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to     oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every     12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment     with at least 2 IV doses and may receive IV therapy for the entire treatment duration.      Approximately 100 to 140 sites globally will participate in this study. Patients with an     ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be     randomized 1:1 to study treatment.   "
142330|NCT01421498|"     The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%)     compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118     Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID     for 12 weeks will also be evaluated.   "
142331|NCT01421485|"     Youth and young adults in the juvenile justice system have a high prevalence of concurrent     psychiatric and substance use disorders and are also at high risk for HIV. However, even when     the disorders and risks are recognized, most programs do not address all of these important     problems and long-term efficacy for all outcomes simultaneously has yet to be demonstrated     for these multi-problem youth. Adverse outcomes for youth include partially treated or     relapsing psychiatric disorders, continued substance abuse, unchanged HIV risk, and further     legal problems. This project, in collaboration with the Rhode Island Family Court, with whom     we have existing collaborations, will address these issues by implementing an Integrated     Treatment Program (ITP) that targets mental health/substance abuse disorders and HIV risk.     ITP is novel by targeting multiple adolescent problems simultaneously, involving parents to     augment change, and its delivery within the Family Court. This study will extend our previous     efficacious interventions among youth with psychiatric disorders to court-involved youth.     Adolescents and their parents will be enrolled from the Rhode Island Family Court Mental     Health Clinic where youth aged 13-17 are referred by judges for comprehensive assessment and     referral for treatment. This randomized controlled trial will test the efficacy, among 200     sexually active court-involved youth who need outpatient treatment, of the novel, integrated     treatment (ITP, n=100) as compared to enhanced standard care in community outpatient services     (ESC, n=100) over an 18-month period (6 months of ITP or ESC and 12 months of follow-up). ITP     consists of three components: 1) individual cognitive behavioral therapy which includes a     motivational interviewing component and is modular-based to address concurrent mental health     and substance abuse issues; 2) family and parent training sessions to address parental     communication and monitoring to support risk reduction among youth; 3) multifamily group     workshops to address HIV risk, family communication and peer resistance skills. Youth in both     conditions (ITP and ESC) will receive similar case management services from the court and     psychiatric medication management (if needed) from a study psychiatrist. ITP will be compared     to ESC on reductions in sexual risk behavior, substance use, symptoms of psychiatric     disorders, and legal offenses.   "
142332|NCT01421472|"     To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with     paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative     locally advanced operable breast cancer patients.   "
142333|NCT01421459|"     The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus     Lantus in controlling blood sugar levels in combination with two or more oral diabetes     medications.   "
142334|NCT01421446|"     This study is comparing a new computer-based method of administering neuropsychological tests     to the standard method of verbal and paper/pencil tests administered in person by an     examiner. The purpose of the research is to determine if the computerized and standard     testing methods are equivalent.   "
142335|NCT01421433|"     Non inferiority, multicentric, double blind study whose the primary objective is to compare     the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain     average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain     evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal     system.   "
142336|NCT01421420|"     The main objective of this research project is to provide a comprehensive clinical database     of patients with Alzheimer's disease (AD) and other forms of dementia, individuals with mild     cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to     identify cognitively normal individuals at genetically defined risk for Alzheimer's disease     through genetic screening.      All participants are seen annually. Autopsies to establish diagnoses in patients with     dementia, patients with mild MCI, and cognitively normal elderly control subjects will also     be conducted.   "
142426|NCT01420237|"     The purpose of this study is to evaluate the success rate of cementless primary hip     replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip     systems in the literature, through absence of femoral head dislocation at 10 years     postoperative.   "
142427|NCT01420224|"     The study hypothesis is that commercial air travel causes an increase in the blood pressure     in the lungs (pulmonary artery pressure) that can be clinically relevant. Portable     echocardiography (heart ultrasound) now offers a non-invasive means of studying this     in-flight.   "
142428|NCT01420211|"     The objective of the study is to assess the hepatic uptake of Primovist® after intravenous     administration of 25 µmol/kg body weight in 56 healthy volunteers and in 60 patients with a     liver disease in dependence on the OATP1B1- and OATP1B3-genotype.   "
142337|NCT01421407|"     Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD),     including those who are undergoing long-term haemodialysis treatment. sHPT is characterized     by persistently elevated levels of parathyroid hormone (PTH) and major disturbances in     phosphorus and calcium metabolism. When glomerular filtration rate (GFR) falls, the     phosphorus clearance decreases significantly, leading to phosphorus retention. The resulting     hyperphosphatemia is thought to be one of the principal causes of secondary     hyperparathyroidism which is a very early complication of patients with CKD. Its diagnosis     and treatment is crucial in the management of such patients.The treatment of the sHPT of     CKD's patient includes dietary phosphate restriction, the use of phosphate binders,     correction of hypocalcaemia, the use of vitamin D and its derivatives. The calcimimetic agent     cinacalcet hydrochloride may be also used in combination with vitamin D. While the majority     of patients can be controlled in this way, medical therapy is not always successful in     achieving adequate control of secondary hyperparathyroidism. Oral medications (calcimimetics,     recently developed phosphate binders, and active vitamin D derivatives amount to very high     monthly costs, and have efficacy limitations as well as side-effects.      HIFU may become a valuable alternative treatment that help control secondary     hyperparathyroidism in selected patients presenting with enlarged parathyroid gland(s)     visible at ultrasonography,.      The aim of this study is to evaluate the efficacy and safety of HIFU treatment in chronic     haemodialysis patients with secondary hyperparathyroidism presenting with enlarged     parathyroid gland(s) which are visible at ultrasonography and for whom medical therapy has     been unsuccessful.   "
142338|NCT01421394|"     This prospective study will assess thoroughly functional deficits and their significance in     the light of rehabilitation in spinal cord injured patients.   "
142339|NCT01421381|"     This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare     this with the last visit from the SNT-II-003 study.   "
142340|NCT01421368|"     The purpose of the study is to examine the effects of two contraceptive methods and the     menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect     of the contraceptive methods on markers of mucosal safety.   "
142341|NCT01421355|"     Specific Aim: To establish the feasibility of studying the change in endothelial function     caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that     inhibits bilirubin conjugation, will be used to induce moderate hyperbilirubinemia.     Endothelial function will be measured before and after atazanavir therapy. In addition,     plasma markers of antioxidant capacity and oxidant stress will be measured as     proof-of-concept that induced moderate hyperbilirubinemia has favorable effects on oxidative     stress in type 1 diabetes.   "
142342|NCT01421342|"     The overall purpose is to determine research based 'next-steps' for outpatients with major     depressive disorder who have not had satisfactory outcomes to standard 'first-step'     treatments. The primary objective is to compare the acute (up to 12 weeks) treatment     effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-SR vs.     switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major     Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on     antidepressant (SSRI or SNRI or mirtazapine) monotherapy. The secondary objectives are to     compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects     on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs     and cost-effectiveness of each of the three treatments.   "
142343|NCT01421329|"     The investigators propose that healthy behaviors such as exercise could be increased through     interactive interventions and weigh-ins (ie weekly emails, questionnaires, weigh-ins, and pay     for participating in a study).   "
142344|NCT01421316|"     Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this     limited survival it is important to consider quality of life (QOL) when treating these     patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT     itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in     patients with brain metastases. Both fatigue and hair loss were reported to have the largest     decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung     cancer. Recent technological improvements in patient positioning and treatment planning will     allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp.     In view of the large impact of hair loss on quality of life, the investigators hypothesize to     see an improved quality of life with scalp sparing techniques.      Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent     clinically important improvement in QOL.   "
142345|NCT01421303|"     Patients with Ankylosing spondylitis more frequently discontinue work. This study measures     the impact of Enbrel on work participation.   "
142346|NCT01421290|"     The hypothesis of this study is to investigate whether surgical intervention is necessary for     patients who suffer from cartilage lesions of the knee, or whether this surgical intervention     can be avoided or postponed by using conservative treatment options such as physiotherapy,     nutrition supplements, intra-articular injections, bracing.      Forty patients suffering from cartilage lesions in their knee joint will be selected     preoperatively. All these patients fulfil certain inclusion- and exclusion criteria. They     will be asked to respond to 3 different questionnaires. These questionnaires include the     visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome     Score or KOOS and the International Knee Documentation Committee (IKDC) form to evaluate the     effect of their cartilage lesion on activities in daily life. Six months later +/- 20     patients will have had surgery and +/- 20 patients will have had conservative treatment, both     groups of patients will be asked to respond again to the 3 different questionnaires. The     outcome of the results will tell us more of the evolution both between groups and in each     group separately.   "
142347|NCT01421277|"     This study will describe the reasons for triptan utilization patterns (continuation and     discontinuation) in triptan-naïve participants and assess the stability of treatment     utilization patterns over time according to standard medical guidelines or clinical practice     standards of the investigating physician.   "
142348|NCT01421264|"     In this open-label, pilot study the investigators will be assessing gabapentin's effects on     insomnia and other concussion-related symptoms in patients with a recent concussion     experiencing insomnia.   "
142350|NCT01421238|"     The purpose of this study is to study how people make decisions regarding delivery room     management for infants born extremely premature when survival and long term outcomes are     uncertain. The hypothesis is that the way in which information is presented will impact     decisions.      There have been many advances in neonatal care in recent decades. However, the investigators     do not know if these children will grow up to be healthy or if they will have problems with     mental retardation, behavior or physical handicaps. In these circumstances, where the medical     profession cannot predict what sort of life a child will have, parents have a choice of     having intensive care started or of allowing the baby to die naturally. The age most often     cited by physicians at which this care is optional and under parental discretion is 23 weeks     gestation.      The purpose of this study was to ask people, recruited through the world wide web, what they     would want for the doctor to do in the case of a hypothetical 23 week premature delivery in     order to evaluate the decision process and the presence of autonomous choice. This study had     two parts. The first part, presented outcome information in 2 different ways -either as     survival and lack of severe disability or as mortality and presence of severe disability. The     results of the first part have been published (Message Framing and Perinatal Decisions,     Pediatrics, 2008). The second part, investigated whether the way in which the way in which     delivery room management options were presented- either as agreeing with a course of action     or opting out- impacted resuscitation decisions. This part was administered as a separate     survey to a different sample of participants at a later date. The remainder of the     questionnaires asked demographic and opinion questions as a means to assess variables that     may influence how people respond to the information they receive.   "
142351|NCT01421225|"     The investigators are conducting this study to find out whether a new device can control     blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have     high blood sugar levels because they do not make enough insulin. The standard treatment is to     give insulin either by shots or using an insulin pump. A new device, called closed-loop     insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a     computer. The CGM will send the sugar levels to a computer which automatically figures out     how much insulin to give and then gives that amount of insulin through the insulin pump. It     will give the child insulin to bring sugar levels down if they are high, and will give less     insulin if the child's blood sugar is getting lower. Earlier research using closed-loop     insulin therapy has shown the ability for it to improve diabetes care in adults and older     children, but there has been no research of closed-loop insulin therapy in young children.     This study will compare children's current insulin therapy with the closed-loop system. The     knowledge that the investigators gain from this research will help us to figure out whether     closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes     care.   "
142352|NCT01421212|"     The purpose of this study is to find the best monthly dose schedule for the new Hepatitis     Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent     Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to     prevent hepatitis B reinfection following liver transplantation in patients with end stage     liver failure due to hepatitis B infection.   "
142353|NCT01421199|"     The study has three objectives:        1. To determine if the device can detect if middle ear fluid is present in children who are          scheduled for tube placement (myringotomy)        2. If fluid is present to characterize the fluid as thick or thin        3. Evaluate the safety of the device   "
142354|NCT01421186|"     This is an open-label, multicentre, dose escalation study to characterize the safety and     preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects     with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with     relapsed/refractory multiple myeloma in combination with standard therapy.   "
142355|NCT01421173|"     The goal of this clinical research study is to find the highest tolerable dose of vorinostat     that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant.     Researchers also want to learn about the safety and level of effectiveness of this     combination.      Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic     material of cells), which may cause cancer cells to die.      Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells     to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not     allowing these cells to repair the DNA damage caused by busulfan or melphalan.      Vorinostat is designed to open up the DNA and allow greater access to drugs that bind to DNA,     such as gemcitabine, busulfan and melphalan.   "
142356|NCT01421160|"     This study aims to determine the causal relationship between regulating urine pH levels     between 7.0 and 7.5 and decreasing chronic joint pain. The investigators hypothesize that     maintenance of an alkaline urinary pH will result in a decrease in personally reported levels     of chronic joint pain using a citrate treatment regimen.   "
142357|NCT01421147|"     The purpose of this study is to compare the effectiveness and safety of LY2963016 versus     Lantus when taken once daily in combination with insulin lispro before meals three times a     day.   "
142358|NCT01421134|"     Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with     mixed features.This clinical study is designed to test how well Lurasidone works to treat     major depressive disorder with mixed features.   "
142359|NCT01421121|"     A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and     immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.   "
142360|NCT01421108|"     This study explores the effectiveness of message framing, loss-framed vs. gain-framed     messages on oral health in Iran.   "
142370|NCT01420978|"     When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often     develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the     brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to     drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a     patient does not tolerate this and a permanent surgery needs to be done to internalize a     shunt.      Though this is done commonly and routinely throughout the world, there are no good studies to     address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a     level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will     allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve     perfusion at the level of the microcirculation in the brain, and result in improved     neurologic outcomes.   "
142395|NCT01420653|"     The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are     greater than acetaminophen, ibuprofen or placebo.   "
142396|NCT01420640|"     The investigators will conduct a large randomized controlled trial comparing the     effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for     fibromyalgia. In addition, the investigators will determine the optimal frequency and     duration of a Tai Chi intervention for short and long-term effectiveness.   "
142361|NCT01421095|"     Young adult cancer survivors constitute an under served population to whom fertility     potential is particularly important. For female young adult patients, cancer treatment such     as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in     risks of infertility and premature menopause related to ovarian failure. Reproductive issues     are a major concern for young cancer survivors, but one that is understudied. Young cancer     survivors have few tools to measure post-treatment ovarian reserve, or the quantity and     quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential     would not only be an important research tool, but also directly impact clinical management.     The purpose of this study is to test if basal and provocative ovarian reserve testing can     predict return of menses in female young adult cancer survivors, to compare basal and     provocative ovarian reserve testing results between female young adult cancer survivors and     healthy controls, and to compare basal and provocative ovarian reserve testing results     between female young adult cancer survivors on and off of combined estrogen and progesterone     hormone products.      Participants will be asked to keep track of their periods over three months. If a participant     is taking birth control pills, patches, or vaginal ring, they will asked to come off the     birth control for 3 months. Participants will also be asked to undergo ovarian reserve     testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.   "
142362|NCT01421082|"     The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality     of life, exercise capacity, and static lung volumes, in patients with emphysema. The     mechanism of action for these effects is believed to be related to the restoration of elastic     recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is     to evaluate several physiologic parameters which should provide measures directly related to     the mechanism of action by which the coils produce these outcomes.   "
142363|NCT01421069|"     This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3     subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis     related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96     weeks of participation in study 0881A1-3338 (B1801014). The study contains an active     treatment period, withdrawal/re-treatment period and a observational period (non-treatment).   "
142364|NCT01421056|"     The purpose of this study is to evaluate the safety and tolerability of ascending oral doses     of CHF 5074 after prolonged administration to patients with mild cognitive impairment.   "
142365|NCT01421043|"     This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg     is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.   "
142366|NCT01421030|"     This study compares clinical, self- reported and cost outcomes in children and adolescents     treated with pulmonary valve implantation, percutaneous versus open surgical technique. Since     cardiac surgery in children and adolescents affect the whole family, the experience of the     patients and their closest relatives are recorded and analysed separately. Cost may be an     important factor in the choice of technology (1). Hence, the present study also aims to     compare savings in costs, percutaneous versus open technique, related to the individual,     their family and society.      1.2 Research questions        1. Percutaneous pulmonary valve implantation or open heart surgery; what are the patients'          and their closest relatives narrative experiences        2. Is there a difference in patient and their closest relatives reported outcomes, measured          as health related quality of life, in patients with congenital pulmonary disease before          the event, 1, 3, 6 and 12 months after percutaneous intervention versus open heart          surgery approach?        3. What is the relationship between patient reported outcomes and clinical outcomes before,          1, 3, 6 and 12 months after the treatment?        4. Are there savings in costs related to the individual and their family and society          between the two techniques?   "
142367|NCT01421017|"     This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and test     the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and     radiotherapy (RT) in patients with skin metastases from breast cancer in the second part     (Phase II). Currently this trial is in its Phase II part.   "
142368|NCT01421004|"     This is a multi-center, open-label, two way crossover study designed to test the     bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients     with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate     that those 2 formulations are considered to be the same for all intents and purposes by     making sure they are acting on the body with the same strength and are absorbed in similar     amounts by the body. During the bioequivalence phase, patients will take orally at a daily     dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days     on/2days off dosing schedule, after which time, patients will switch to the alternate     formulation for one additional week. After the bioequivalence phase, all patients may     continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until     disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation     from the study treatment for any other reason.   "
142369|NCT01420991|"     Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year,     40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die     do so before reaching the hospital. Most commonly, SAH results from rupture of an     intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk     and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public     health problem with high lethality. Current estimates are that ruptured aortic aneurysm kills     13,000 Americans each year. Screening efforts have effectively lowered mortality from aortic     aneurysm rupture but a high proportion of those who die did not have a diagnosis of aortic     aneurysm prior to rupture.      The relationship between intracranial and aortic aneurysm has long been recognized, but     poorly quantified. Recent genome-wide association studies (GWAS) provide a molecular     biological evidence for a shared pathophysiology. The chromosome 9p21 locus confers increased     risk for both intracranial aneurysms and aortic aneurysms. These GWAS data, along with     linkage data for other susceptibility loci, indicate that individuals and families harboring     one type of aneurysm may be at especially increased risk of the other.      The rationale for this project is that opportunistic screening for abdominal aortic aneurysms     (AAA) may be warranted in patients who present with aneurysmal subarachnoid hemorrhage. This     study is meant to see if the yield of screening in this population is too low to justify its     routine use. The investigators plan to systematically screen for AAA in all cases of aSAH     presenting to MCH for treatment. If no individual out of 81 consecutively screened cases of     aSAH has evidence of AAA, then the investigators can have strong confidence that there is a     less than 5% chance of finding an AAA in the patient population.   "
142397|NCT01420627|"     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of     EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated     with Adagen.   "
142372|NCT01420952|"     Background:      - (11C)mGlu1 is a new drug that helps to show where a protein, mGluR1, is found in the brain.     The drug contains a small amount of radioactivity that can be detected by imaging studies     like positron emission tomography (PET) scans. By looking at the mGluR1 receptors,     researchers hope to better understand how they are involved in general health, brain     disorders, and addiction.      Objectives:        -  To test how (11C)mGlu1 is distributed in the brain and body.        -  To measure how mGluR1 receptors display (11C)mGlu1 during imaging studies.      Eligibility:      - Healthy volunteers between 18 and 50 years of age.      Design:        -  Participants will be screened with a medical history, physical exam, and blood and urine          tests. This study requires four visits to the NIH Clinical Center.        -  Participants will have an initial evaluation, a magnetic resonance imaging (MRI) scan, a          PET scan, and a final blood sample after the PET scan, all at different visits.        -  The MRI and PET scans will focus on the brain. Participants will receive (11C)mGlu1, and          have scans to see how it shows up in the brain.        -  Some participants will have whole body imaging studies to see how (11C)mGlu1 shows up in          the body.   "
142373|NCT01420939|"     Background:      - A person who has a traumatic brain injury (TBI) -- also called concussion -- can have     serious and long-lasting effects. Doctors who treat TBI need more information about how the     brain changes over time in people with TBI and how well a person recovers from it. To make     existing TBI treatments more effective and develop new ones, researchers want to look more     closely at how TBI affects people both physically and psychologically.      Objectives:      - To collect medical information from people with recent traumatic brain injury and compare     this information to that of healthy volunteers and of persons who have had injuries to other     parts of their bodies besides their heads (such as broken bones, orthopedic injuries, after     surgery).      Eligibility:      3 groups of people between the ages of 18 and 70 years will be asked to take part.        -  Persons who have had a traumatic brain injury (or concussion ) within the past 30 days,          OR        -  Persons who are healthy and have never had a traumatic brain injury, OR        -  Persons who have had an injury within the past 30 days to a part of their body other          than the head (such as a broken bone, orthopedic injury, surgery)      Design:        -  This study requires two outpatient visits each lasting 1 1/2 days. The 2 visits will be          about 30 days apart. Persons with TBI and non-TBI injuries must have their first visit          within 30 days of their injury.        -  Screening: Participants will be screened with a medical history, physical examination,          blood tests and electrocradiogram (ECG a routine heart test).        -  The research will involve:             1. Giving blood samples (no more than 75 ml each visit).             2. Having tests of memory, attention, concentration, and thinking (neuropsychological               testing).             3. Having imaging studies of the head including magnetic resonance imaging (MRI) and               positron emission tomography (PET) scans.        -  Persons with TBI will have the same tests at Visit 1 and 2. Healthy controls and persons          with non-TBI injuries will have the same tests at Visit 1 as listed above. But, at Visit          2, they will not have brain MRIs or PETs.        -  No treatments will be provided as part of this research protocol.   "
142374|NCT01420926|"     This randomized phase II trial studies how well giving decitabine with or without bortezomib     works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy,     such as decitabine, work in different ways to stop the growth of cancer cells, either by     killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether     decitabine works better when given with or without bortezomib in treating acute myeloid     leukemia.   "
142375|NCT01420913|"     The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A,     YHD1119 B, YHD1119 C and Lyrica capsule.      YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.      Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T     max,ss, t 1/2   "
142376|NCT01420900|"     The investigators want to examine if specific acetabular liner designs can be a contributing     factor to audible squeaking associated with CoC bearings. The aim of the present study is to     compare two different designed and well documented acetabular component systems with     reference to squeaking and other noises from the hip.   "
142377|NCT01420887|"     This pilot study is designed to determine if the rehabilitative benefits of continuous     passive motion (CPM) will help preserve/restore the joint function and significantly improve     the rate of recovery of patients after the surgical release of elbow contractures better than     standard physiotherapy and static splinting.   "
142378|NCT01420874|"     The purpose of this research study is for the participant to give their own T cells (a type     of blood cell in the body that can fight infections and possibly cancer) to them after they     have been removed, grown in a lab, and then coated with an experimental drug.      This study will determine the highest dose of EGFR2Bi coated T cells that can be given     without causing severe side effects. Initially a group of 3 participants will receive the     same dose of study drug. If no serious side effects occur, the next group of participants     will receive a slightly higher dose of study agent. The following groups of participants will     receive higher doses of the study drug until a dose is reached where there are unacceptable     side effects and maximum tolerated dose is found, or the planned highest dose level is     reached with no side effects.   "
142379|NCT01420861|"     The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific     antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on     androgen deprivation therapy (Serum PSA response and Serum PSA progression)   "
142380|NCT01420848|"     Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing     School students of Beneficence Portuguese Hospital and review the effectiveness of true and     placebo auriculotherapy.   "
142381|NCT01420835|"     The purpose of this study is to assess stress levels and quality of life in the nursing team     of Samaritan Hospital and evaluate the effectiveness of Chinese auriculotherapy used with and     without closed protocol on reducing the stress levels and improvement of life quality.   "
142382|NCT01420822|"     This post-marketing surveillance study is to investigate possible problems or questions in     safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with     allergic rhinitis under the conditions of actual practical use.   "
142443|NCT01420016|"     The objective of this project is to develop and implement sophisticated point-of-care     Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b)     prioritizes all available evidence-based treatment options to reduce a given patient's     cardiovascular risk (CVR). After developing the EHR-based decision support intervention, the     investigators will test its impact on CVR, the components of CVR, in a group randomized trial     that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults with     moderate or high CVR. This approach, if successful, will (a) improve chronic disease outcomes     and reduce CVR for about 35% of the U.S. adult population, (b) maximize the clinical return     on the massive investments that are increasingly being made in sophisticated outpatient EHR     systems, and (c) provide a model for how to use EHR technology support to deliver     personalized medicine in primary care settings   "
142384|NCT01420796|"     Parkinson's disease (PD) is a chronic, degenerative disease described by motors and     non-motors symptoms. Changes in swallowing and respiratory dynamics increase risk of tracheal     aspiration largely responsible for increased morbidity and mortality in this population.     Thus, interdisciplinary rehabilitation strategies can reduce the complications of dysphagia,     with consequent improvement of the prognosis of individuals with PD. Objective: To determine     the impact of combined oral motor exercises and breathing exercises on swallowing disorders     in individuals with PD. Method: Clinical trial, randomized and blinded for the examinator.     For all subjects will be given the stage of PD and applied quality of life questionnaire. The     swallowing complaints will be investigated through structured questionnaire and functional     aspects of swallowing with videofluoroscopy. The Manovacuometry Spirometry will determine     measures of respiratory function. The assessment of vocal and speech disorders will be done     with perceptive, acoustic, aerodynamic and electroglottographic measures as well as analysis     of intelligibility. Three groups of intervention will be defined: one of them doing oral     motor exercises for swallowing, one doing breathing exercises and another must do this two     interventions combined. Effect of intervention will be assessed through measures of     swallowing, breathing, voice and speech. The groups will be compared, according to the     principle of intention to treat by appropriate statistical tests, according to the     distribution of the dependent variables.   "
142385|NCT01420783|"     Primary Objective:        -  Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg          SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per          European LeukemiaNet criteria) for :             -  Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months               in patients with polycythemia vera, and             -  Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients               with essential thrombocythemia.        -  PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate          the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or          intolerant to hydroxyurea (per European LeukemiaNet criteria) for:             -  Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and               continuing through Day 1 of Cycle 6 visit in patients with PV, and             -  Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit               and continuing through Day 1 of Cycle 6 visit in patients with ET.      Secondary Objectives:        -  To evaluate the safety of SAR302503.        -  To evaluate the efficacy of SAR302503 in patients with PV who are resistant or          intolerant to hydroxyurea for inducing absence of phlebotomy eligibility.        -  To evaluate the efficacy of SAR302503 in patients with ET who are resistant or          intolerant to hydroxyurea for reduction of platelet counts.        -  To evaluate the efficacy of SAR302503 in inducing complete and partial responses          beginning at Day 1 of Cycle 6 visit through Cycle 8.        -  To evaluate splenic response as measured by spleen volume using MRI or CT.        -  To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.        -  To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele          burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition.        -  To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated          symptoms, as well as overall impact on quality of life.        -  To measure generic health-related quality of life and utility value using the EuroQol          Group (EQ-5DTM) questionnaire.   "
142386|NCT01420770|"     Primary Objective:      - To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 for     the reduction of spleen volume as determined by magnetic resonance imaging (MRI).      Secondary Objectives:        -  To evaluate the safety of SAR302503.        -  To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat doses.        -  To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele          burden in those patients with JAK2V617F mutation, changes in substrate phosphorylation          in the JAK-STAT signal transduction pathway, and the expression of cytokines.        -  To measure improvement in baseline Myeloproliferative Neoplasm (MPN) associated          symptoms, as well as overall impact in quality of life (QOL), through serial          administration of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF).        -  To measure generic health-related quality of life (HRQL) and utility values using the          EQ-5D questionnaire.   "
142387|NCT01420757|"     Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up     to 54%. If a mesh is used, the defect can be closed tension-free. Using this method,     recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is     a relatively new technique in which the mesh is positioned intraperitoneally. Research has     shown that this procedure is technical feasible and may have benefits for the patients.      The ongoing debate about the merits of endoscopic versus open incisional hernia repair     prompts the need for a level 1 randomized controlled trial.   "
142388|NCT01420744|"     The purpose of this study is to determine whether the adjunctive therapy to standard     antibiotic treatment of BT086 is safe and effective of decreasing the days patients require     endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP).   "
142389|NCT01420731|"     Back pain is a common hormonal disorder in men that may affect the phases of male sexual     function. The investigators investigated sexual function in male patients with back pain.      A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the     as control group were evaluated with a detailed medical and sexual history, including a     international erectile function index (IEFI) questionnaire and the Beck Depression Inventory.     Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione,     17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These     variables were compared statistically between the 2 groups.   "
142390|NCT01420718|"     The purpose of this study is to compare the human pulp response to partial pulpotomy using     White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.   "
142391|NCT01420705|"     The prevalence of asthma and allergic diseases is increasing worldwide. Infections and     vaccinations in childhood may have an impact on the subsequent development of asthma and     allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin     (BCG) vaccine was associated with reduction in atopy. Since then the investigators have     conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The     present study aims to follow up children enrolled in the BCG randomised trial to assess for     asthma and allergy later in childhood. Based on previous observations, the investigators     expect children allocated to receive BCG at birth will have a reduction in allergy profile     when compared to children who did not receive BCG at birth.   "
142392|NCT01420692|"     The main purpose of this study is to analyze the effects of the addition of sulfonylurea     (gliclazide MR) or ,alternatively, basal insulin (insulin detemir) to life-style modification     and metformin treatment as a second step treatment in type 2 diabetes mellitus on endothelial     cell functions. The second goal is to identify the effects of these treatment alternatives on     body-mass index, the changes in body fat mass, insulin resistance and on the insulin     secretion capacity of beta cells. The third aim of this study is to determine the success     rates of these treatment alternatives on glycemic control at 6 months follow-up.   "
142398|NCT01420614|"     Prospective, randomized, multi-center trial comparing the safety and efficacy in the     prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach     for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing     primary angioplasty   "
142400|NCT01420588|"     The investigators study the feasibility of a novel method in oncology based on breath     analysis with a nanosensors array for identifying gastric diseases. Alveolar exhaled breath     samples collected from volunteers referred for upper endoscopy or surgery are analyzed using     a custom-designed array of chemical nanosensors based on organically functionalized gold     nanoparticles and carbon nanotubes. Predictive models are built employing discriminant factor     analysis (DFA) pattern recognition method. Classification accuracy, sensitivity and     specificity are determined using leave-one-out cross-validation or an independent blind test     set. The chemical composition of the breath samples is studied using gas chromatography     coupled with mass spectrometry (GC-MS).      A pilot study is conducted first (enlistment of 160 subjects at the Department of Oncology,     The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of     Anhui Medical University, Hefei, Anhui, China.)      The pilot study is followed by a large-scale clinical trial to confirm the preliminary     results of the Chinese pilot study (enlistment of 800 subjects at the Digestive Diseases     Centre GASTRO, Riga East University Hospital, 6 Linezera iela, LV1006 Riga, Latvia). 25% of     the samples are used as independent blind test set. The samples are blinded by the medical     team and are not disclosed until prediction of blind sample identity is complete.   "
142401|NCT01420575|"     We hypothesize that the use of a visual decision aid tool to educate patients regarding     potential harm with respect to weight gain with olanzapine versus perphenazine can lead to     better shared decision making by patients, increase rates of antipsychotic switches and     promote weight loss in overweight patients with schizophrenia/schizoaffective disorder.      Our specific aims are the following:        1. To investigate the effects of a visual decision aid, versus care as usual, on patients'          perceived difficulties in medical decision making regarding switching antipsychotics in          overweight veterans with schizophrenia or schizoaffective disorder.        2. To investigate the effects of a visual decision aid and a shared decision making model          on rate of medication switches (from olanzapine to perphenazine) in overweight veterans          with schizophrenia or schizoaffective disorder.        3. To investigate the effects of a visual decision making aid and shared decision making          model on BMI in overweight veterans who switch from olanzapine to perphenazine therapy.   "
142402|NCT01420562|"     The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough     levels of posaconazole reached in patients with different stages of mucositis, due to     chemotherapy and total body irradiation.   "
142403|NCT01420549|"     The purpose of this study is to determine the non-inferiority between two different FDC,     measuring LDL-Cholesterol levels, in high risk patients by NCEP-ATP III, with primary     hypercholesterolemia or mixed dyslipidemia.   "
142404|NCT01420536|"     The objective of this study is to compare the canine guidance (CG) and bilateral balanced     occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture     wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and     mandibular complete dentures and, after the intraoral adjustments and adaptation period, will     randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.   "
142405|NCT01420523|"     Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with     virological success, presenting with clinical lipohypertrophy.   "
142406|NCT01420510|"     We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the     incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.   "
142407|NCT01420497|"     Several studies have shown that in diabetic patients, the glycemic profile was disturbed     after intra-articular injection of corticosteroids. Little is known about the impact of     epidural injection in such patients. The goal of this study was double, at first comparing     the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate     methylprednisolone either intra-articular or epidural, secondly to compare the amount of     systemic diffusion of the drug the after both procedures.   "
142408|NCT01420484|"     The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with     pronounced variation of arterial pressure will be assessed under analgosedation.      Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP     undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic,     and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data     will be analysed in different periods of arterial pressure for agreement of the two methods     and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic     error). Additionally, we will compare both methods regarding the amplitude and time of very     fast changes in arterial pressure during intervals of functional cardiac arrests (rapid     pacing).   "
142409|NCT01420471|"     All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the     inclusion/exclusion criteria will be included in the study.      All patients enrolled in this study will have spacers (impregnated with saline or     Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as     their own controls. Nostril's will be randomized to either the experimental treatment     (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer).     These spacers will be removed after 6-days post-op.      Participants will undergo the standard post-operative endoscopic sinus surgery follow-up     appointments plus one additional research visit (not standard of care). This includes     follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the     post-operative period. During these appointments, the surgeon will assess the post-operative     mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be     administered, as per standard protocol, at each post-op follow up visit.      Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up     appointments for analysis.      Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in     a perforated glove finger improves patient outcomes, wound healing and reduces inflammation     compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS     patients receiving FESS.      Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard     saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.   "
142410|NCT01420458|"     This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will     be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled     concurrently.   "
142415|NCT01420393|"     Atrial fibrillation and heart failure are two common heart conditions that are associated     with an increase in death and suffering. When both of these two conditions occur in a patient     the patient's prognosis is poor. These patients have poor life quality and are frequently     admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is     extremely challenging. Two options for managing the atrial fibrillation are permitting the     atrial fibrillation to continue but controlling the heart rate, or to convert the atrial     fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now,     the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies     using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when     compared with permitting the patient to be in atrial fibrillation. In the last few years, new     development in techniques and technologies now enable catheter ablation (cauterization of     tissue in the heart with a catheter) to be a successful treatment in abolishing atrial     fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm.     However, there has not been any long-term study to determine whether catheter ablation to     abolish atrial fibrillation in heart failure patients would reduce mortality or admissions     for heart failure.      This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm     control to rate control in patients with heart failure and high burden atrial fibrillation on     the composite endpoint of all-cause mortality and hospitalization for heart failure defined     as an admission to a health care facility for > 24 hours. The investigators will also be     assessing the cost-effectiveness of this treatment strategy and the life quality for these     patients. This study may have a dramatic impact on the way the investigators manage these     patients with atrial fibrillation and heart failure and may improve the outlook and well     being of these patients.   "
142416|NCT01420367|"     Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime     in preventing post-operative complications in paediatric patients with simple appendicitis.      This project will compare patients 16 years and under with simple appendicitis (appendicitis     that is not perforated or gangrenous). Patients will be randomly divided into two groups;        -  Group one will receive a single pre-operative dose of antibiotics (metronidazole          12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline          (placebo) eight and sixteen hours after the initial dose, respectively.        -  Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up          to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen          hours after the first dose, respectively.      Group allocation will be concealed from the patient and their guardian, the treating surgical     team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if     required will be in place.      The aim of the study is to determine if a single dose of antibiotics is as effective as three     doses in preventing post-operative infection. This will be assessed by comparing:        -  Duration of hospital stay from operation until discharge, based on a standardised          discharge criteria.        -  Development of wound infection or requirement of antibiotics in the six weeks          post-operation        -  Need for re-admission.      Information will be collected prospectively from each patient's hospital notes and from a     follow-up phone call six weeks after the operation.   "
142417|NCT01420354|"     This study will sought to determine if limited urine collections can provide similar or more     informative data than standard 24-hour urine collections used to evaluate kidney stone     formers.   "
142418|NCT01420341|"     This is a randomised, open-labelled, controlled trial to compare the efficacy and     effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of     melioidosis. The study population includes 800 patients with culture-confirmed melioidosis     whom 12 weeks of oral eradication therapy have been completed with or without intravenous     intensive antibiotics. Patients will be randomised to either stop the eradication treatment     or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen     used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.   "
142419|NCT01420328|"     This study focuses on the use of Vytorin to study inflammatory markers in subjects with     normal cholesterol.   "
142420|NCT01420315|"     Recent studies indicate that there is a relationship between cognitive decline and vitamin D     deficiency. Up to now, no study has investigated the prevalence of vitamin d deficiency in     patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D     deficiency and analysis the associated characteristics in patients with Alzheimer's disease.   "
142421|NCT01420302|"     The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed     protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients   "
142422|NCT01420289|"     To evaluate the effects of HPIPC for the treatment of symptoms of PAD   "
142423|NCT01420276|"     Back paın is a common hormonal disorder in women that may affect the phases of female sexual     function (FSD). We investigated sexual function in patients with back paın A total of 54     women with back paın and 27 age matched voluntary healthy women who served as the as control     group were evaluated with a detailed medical and sexual history, including a female sexual     function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin,     dehydroepiandrosterone sulfate, free testosterone, androstenedione,     17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These     variables were compared statistically between the 2 groups.   "
142424|NCT01420263|"     The purpose of this study is to determine whether re-feeding of gastric residuals reduces the     time needed to establish full enteral feedings in premature infants. Infants with gestational     ages 23-28 weeks at birth will be randomized within one week to receive either gastric     residuals or fresh formula or breastmilk whenever significant residuals during feeding     advancement require clinical assessment for continuing feedings. Primary outcome measure is     time to establish full enteral feedings (120cc/kg/day).   "
142425|NCT01420250|"     This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with     concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation     therapy that uses computer-generated images to show the size and shape of the tumor. Thin     beams of radiation of different intensities are aimed at the tumor from many angles.) and     androgen deprivation therapy (Treatment to suppress or block the production or action of male     hormones) in patients with locally advanced prostate cancer.      It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control     can be achieved and eventually the cure rate can be increased. After this study, the     maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can     be found.      Men with locally advanced high risk prostate cancer represent a group of patients for whom     cure is potentially achievable utilizing a multimodality approach. More aggressive treatment     upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize     that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel     approach will improve disease control and eventually improve survival for locally advanced     prostate cancer patients.   "
142429|NCT01420198|"     An increasing proportion of Sweden's population comprises non-European immigrants, who     constitute a high risk-population for T2D. Numbering almost 9,000 individuals, Iraqi citizens     represent the largest immigrant group in Malmoe and are identified as a risk group for Type 2     Diabetes (T2D) in whom genetic and lifestyle factors probably play significant roles in the     development of T2D.      Several studies have shown that adoption of an active lifestyle by at-risk individuals     dramatically reduces the risk of T2D. However, there are currently no established methods for     providing support to high-risk individuals from different cultural and social backgrounds to     help them adopt beneficial lasting lifestyle changes. Instead of just waiting for Iraqi     high-risk individuals to develop T2D, this project will implement and assess lifestyle     intervention programs aimed at reducing the risk of developing T2D and tailored to     individuals with a different social and cultural background.      The study thus seeks to optimize preventive action in health care and aims to facilitate the     adoption of permanent changes in lifestyle in high-risk patients, taking account of cultural     and social barriers.      Since T2D is associated with a sedentary lifestyle and develops earlier in men than women and     an average 10 years earlier in immigrants from the Middle East than in native Swedes, it is     crucial to study pathogenic mechanisms triggering T2D development in relation to sex,     lifestyle and ethnic background. The results will provide the basis for deciding how health     care providers can actively work to prevent T2D and other lifestyle-associated diseases in     this high-risk population that has not been studied before.   "
142430|NCT01420185|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors identify and learn more about biomarkers related to cancer. It may also help     doctors predict whether cancer will come back after treatment.      PURPOSE: This research trial is studying genes that may predict local recurrence in samples     from patients with breast cancer. treated on NSABP-B-28   "
142431|NCT01420172|"     This will be a retrospective study and analysis of subjects who have undergone a     hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC     at any time between 01Jan2000 and 30Jun2011.      This study will determine factors influencing pulmonary disease and associated treatment     strategies.   "
142432|NCT01420159|"     This study investigates the treatment of acute pain, an unpleasant feeling caused by an     injury. The overall purpose of the study is to gain more information that the pain relief     medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive     green, whistle like object that you breathe through) is safe and works at relieving pain in     patients aged 12 years and older who are admitted to a hospital Emergency Department with a     minor injury (known as trauma).   "
142433|NCT01420146|"     Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled     trastuzumab.   "
142434|NCT01420133|"     Few recommendations concerning the diet and dosage to be administered to patients treated     with corticosteroids are established.      It therefore seems important to study prospectively the indication of a diet low in salt and     sugar in patients undergoing corticosteroid therapy, to record side effects observed and to     measure their frequency.   "
142435|NCT01420120|"     This is a prospective multicenter registry to evaluate safety and performance of the REMEDY,     biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral     arteries. Patients will be followed for a period of 1 year.   "
142436|NCT01420107|"     A video of the delivery room management will be taken using standardized conditions. The     video will be evaluated either locally by those directly involved in the delivery room care     of this specific infant or anonymously at the main study center. Using a standardized     evaluation form a set of predefined interventions is rated regarding at what time they took     place and at what time they should have taken place. The difference in time for all     interventions is summed up to a score. This score should allow to assess the delivery room     management in comparison to the desired standard as well as between hospitals. The evaluation     forms of all centers will be analyzed at the main study center to define correlations between     certain delivery room interventions and short term outcome.      Aim of the study is to        -  gather data on how delivery room care is currently done,        -  come closer to an agreement between different NICUs towards what should be done in the          delivery room under what circumstances in which way,        -  find those interventions with potential influence on short term outcome. Those aspects          of management that are different between centers and show correlation with short term          outcome will be the focus of future prospective intervention trials in order to find the          best way how to take care of preterm infants in the delivery room.      Hypothesis:      In preterm infants <32;0 weeks of gestational age a correlation exists between specific     delivery room interventions and short term outcome.   "
142437|NCT01420094|"     To compare the safety and efficacy (onset, duration of relief and overall efficacy) of a     single dose of a fast release formulation of aspirin 1000 mg compared to acetaminophen 1000     mg and placebo for relief of pain following extraction of impacted third molars.   "
142438|NCT01420081|"     This study will investigate the individual safety and efficacy of two dual PI3K/mTOR     inhibitors in patients with recurrent endometrial cancer.   "
142439|NCT01420068|"     52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and     development in pediatric hypertensive patients previously treated with aliskiren in studies     SPP100A2365 and SPP100A2365E1   "
142440|NCT01420055|"     This is a prospective, open-label, multi-center phase IV study to assess response to     fingolimod initiation according to coping profile in adult patients with highly active     relapsing remitting multiple sclerosis in France.   "
142442|NCT01420029|"     In this observational pilot project, the investigators plan to document duration and sources     of exposure to plasticizers in infants born at birth weights less than 1500 grams. The     investigators will examine the association between exposure to plasticizers and outcomes such     as performance on a neurological screening tool, extrauterine growth, and thyroid function.   "
142444|NCT01420003|"     The purpose of this study is to characterize the time course of B cell activation after     allergen challenge, and more specifically measure the M1 prime related biomarkers.   "
142644|NCT01417377|"     This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of     Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease     previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.   "
142446|NCT01419977|"     Sickle cell disease (SCD) is one of the most common inherited diseases worldwide and exhibits     highest frequency in people of African descent. Patients with SCD currently have few     treatment options, with hydroxyurea being the only medication approved to reduce the     frequency of vaso-occlusive crisis (VOC) and prevent other SCD complications such as acute     chest syndrome. Once patients develop VOC, hospitalizations aim to alleviate pain; no     specific therapy is currently available to otherwise affect the course of the VOC. However,     there has been increasing interest in the role of coagulation in the pathogenesis of SCD. The     investigators hypothesize that low dose anticoagulant therapy, such as prophylactic dose     low-molecular-weight heparin (LMWH), could be a novel way to ameliorate the vaso-occlusive     process and thereby hasten the resolution of pain.   "
142447|NCT01419964|"     This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel     group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of     achromatic areas in patients with vitiligo.   "
142448|NCT01419951|"     The objective of this project is to pilot test a behavioral intervention that includes a home     visit component compared to a clinic only and standard of care for the treatment of obesity     in preschool age children. The results of this study will inform the design of a larger     randomized control trial.      H1: The clinic + home intervention will result in a significantly greater decrease in BMIz     compared to the in clinic only intervention or pediatric standard of care at 6 months     post-treatment.   "
142449|NCT01419938|"     Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep     disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian clock     is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at night     and sleeps until 02.00-03.00 in the afternoon. This syndrome is most frequent among young     people between 16-25 years, which conveys that school attendance and education are affected,     and also often results in severe social consequences. DSPS is sometimes associated with     depression and personality disorders and may aggravate psychiatric symptoms.      This syndrome is highly underdiagnosed and there are no detailed guidelines how to treat it.     The treatment usually consists of light therapy, chronotherapy or melatonin. There is a lack     of guidelines how often, with which wavelength, and how long the treatment of DSPS patients     shall go on. Previous studies shows that light therapy often is effective. The effect gets     even better if melatonin is administered concurrently. However, the frequency of relapse is     high.      Thus, DSPS is a prevalent syndrome in young adults with severe consequences on normal daytime     functioning. There are almost no treatment options available in health care settings. There     is a clear need for further studies on this topic. The main purpose of the present study is     to evaluate the clinical effects of short and long-term treatment by using light therapy and     cognitive behaviour therapy (CBT). CBT is recommended at mild to moderate depression and     anxiety. It also has some evidence in treating insomnia. Patients with DSPS often have al of     these symptoms and therefore the investigators would like to investigate if CBT can enhance     the effect of light therapy.      Firstly, the investigators want to evaluate the short-term effects of light therapy with and     without CBT. Secondly, the investigators want to evaluate if the patients who get CBT     maintain a normal sleep rhythm and prevent relapse of DSPS compared to just light therapy     for two weeks.      The investigators also want to evaluate how this patient-group differs when it comes to     behavioral factors compared to a matched reference group.   "
142450|NCT01419925|"     Multimeric-001 (M-001) has been recently developed, containing conserved, common linear     influenza epitopes that activate both cellular and humoral arms of the immune system against     a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an     attractive candidate for priming immune responses to seasonal influenza vaccine in the     elderly population. The current clinical study was designed to assess M-001's standalone and     priming action in subjects over 65 years old.      This is a second Phase II study comprising 120 participants. Eligible subjects were     randomized to receive to receive either two sequential non-adjuvanted or a single     non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment),     or one placebo (saline) injection, before receiving the TIV.   "
142451|NCT01419912|"     Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats,     inositols might have beneficial effects on controlling complication among diabetic     nephropathy patients(DN).Most studies in this regard have been examined the effect of soy     consumption on cardiorenal risk factors among patients with DN and there are few data about     relationship of soy milk consumption and health effect in patients with DN . Therefore, we     evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation,     oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients.     This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic     nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk     or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.   "
142452|NCT01419899|"     The purpose of this study is to determine if a brief intervention delivered to emergency     department patients increases the uptake of rapid HIV and hepatitis C testing in comparison     to no brief intervention.   "
142453|NCT01419886|"     Swallowing disorders (dysphagia) are common in adult patients. There is emerging evidence     that dysphagia itself can cause adverse medical outcomes. There is a three-fold increased     risk for pneumonia in these patients versus similar patients without dysphagia. Patients with     dysphagia also suffer poor nutrition and dehydration. Patients can become so malnourished     that it slows their recovery. Dysphagia can cause choking when food or liquid enters the     lungs. Over time, this will cause pneumonia and even death. More acutely, patients fear that     their choking will cause them to suffocate and die. Over time, patients are embarrassed to be     seen choking and thus feel forced to dine alone. These patients report feelings of isolation     and depression. To date, there are no practical methods to assess these adverse outcomes of     swallowing difficulties in patients. This research will be the first to address this gap.     Specifically, as part of previous research (PhD dissertation by RM, the PI) a new measure of     medical outcomes of dysphagia was developed, titled the Medical Outcomes of Dysphagia (MOD)     scale. The MOD consists of 3 subscales that each measure lung, nutrition-hydration or     psychological consequences in patients with swallowing difficulties. Unlike more expensive     and complex tests, the MOD has been designed for both in- and outpatients. This research will     validate each MOD subscale to ensure retention of only items that are reliable and valid for     use with patients who have dysphagia due to any disease etiology. The final MOD subscales     will be the first to allow clinicians to track medical complications in their patients and to     ensure that treatment is effective. Globally, the MOD subscales will direct limited health     care resources to the most effective treatments for swallowing disorders.   "
142645|NCT01417364|"     The general hypothesis is that administration of testosterone to healthy, older men for 52     weeks (1 year) following a cycle of 4 weeks of testosterone administration and 4 weeks     without testosterone (i.e., monthly cycled regimen) will provide the same gains in muscle     strength, muscle mass, and bone density as standard of care (SOC), continuous administration     of testosterone for 52 weeks.   "
142454|NCT01419873|"     Very low birthweight neonates commonly develop high blood sugar levels. There is an     association between high blood sugar levels and poorer short term outcomes but it is not     known whether the high sugar level itself actually causes the problems.      There are a range of ways to manage high sugar levels but there are no consensus guidelines     to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies     looking at insulin infusions have often used fixed protocols to guide the amount of insulin     to be given and are often complicated by hypoglycaemia.      This study investigated whether using a model-based approach to individualise insulin     administration to neonates with high sugar levels would provide a safe and effective     management option for controlling blood sugar levels and avoid the complication of low blood     sugar levels.   "
142455|NCT01419860|"     The aim of the study is to describe utility of dynamic fluorescence videoangiography of     indocyanine green (ICG) in gastrointestinal surgery, for evaluation of microcirculation in     colon wall and anastomosis before and after surgical resection; and if this technique can     guide the surgeon to peroperative decision making considering recreate a new anastomosis or     stoma for preventing anastomotic failure or stomia necrosis.   "
142456|NCT01419847|"     Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of     onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior     cost and safety profile compared to systemic therapy.   "
142457|NCT01419834|"     The purpose of this study is to find out if humanized 3F8 (Hu3F8) is safe for treating     neuroblastoma and other cancers. A phase 1 study means the investigators are trying to find     out what side effects happen when higher and higher doses of a drug are used.      The investigators want to find out what effects, good and/or bad, Hu3F8 has on cancer. The     amount of Hu3F8 that patients gets will depend on when they start treatment on this study.     The investigators also want to find out more about how Hu3F8 works and how effective it is in     attacking the disease. Hu3F8 is an experimental drug, which means it has not yet been     approved by the FDA for the treatment of this disease.   "
142458|NCT01419821|"     Abstract Background: Vitamin D affects a wide variety of functions in the body including     regulation of calcium, phosphorus, and bone metabolism. Israeli studies have documented a     high prevalence of Vitamin D deficiency in Israeli infants in general, which was more severe     in infants from Ultra-Orthodox Jewish families. Modest dress requirements in this population     drastically reduce sun exposure, known to encourage production of Vitamin D. Countless     research has analyzed preterm as well as term neonates born to mothers with vitamin D     deficiency, with regard to weight, height, and bone mineral density at birth. However, there     is a paucity of information about healthy infants' vitamin D levels and its' correlation to     these parameters during the first few years of life. Objectives: The purpose of the proposed     study is to measure and correlate levels of 25(OH)D and bone mineral density towards the end     of the first year of life with growth rates and bone mineral density in the same children at     the ages of 2, 3 and 5 years. Patients and Methods: The study will be performed in the     Ultra-Orthodox Jewish community of Beitar Illit. 25(OH)D levels will be taken between 9-12     months of age (when routine blood tests are normally drawn for these infants) and bone     mineral density will be measured using Quantitative Ultrasound. Infants will be divided into     2 groups: those with those with normal 25(OH)D levels (>15ng/ml), and those with 25(OH)D     deficiency (<15ng/ml). Group 1- normal levels will receive no intervention. Infants with     25(OH)D below 15ng/ml will be randomly assigned into one of two groups; Group 2-those     receiving continued vitamin D supplementation of 800 international units(IU) (4gtt/d) for one     year, or Group 3- those receiving the placebo. Height, weight, and head circumference growth     curves will be recorded every two months until 2 years of age. Quantitative ultrasound,     growth charts and blood tests including 25(OH)D, serum calcium and phosphate levels,     Parathyroid hormone (PTH), and alkaline phosphatase, taken at approximately 9-12 months will     be repeated at 2 years of age. At that time children from Group 1 (no supplementation) will     be divided into three: Group 1a- normal 25(OH)D levels will continue with no intervention,     Group 1b <15ng/ml will begin receiving vitamin D 4gtt/d, Group 1c <15ng/ml will receive a     placebo until age three. Groups 2 and 3 will continue their previous treatment until age     three. All aforementioned tests will be repeated at age 3, when treatment will stop, and the     same tests will be repeated at age 5.   "
142459|NCT01419808|"     The purpose of this study is to investigate whether treatment of scaphoid non-unions with a     vascularized bone grafts improves patient reported pain and disability compared to treatment     with a non-vascularized bone graft. Secondary objectives are to examine if there is any     difference in the overall rate and time to union, range of motion, grip strength, or     complication rates between the two groups.      In addition, this is the first prospective randomized study to directly compare the two     techniques. This is also the first study to use standardized methods of assessing union     (based on computerized tomography), standardized methods of collecting objective patient     data, and utilizing validated patient questionnaires to assess pain and disability.   "
142460|NCT01419795|"     This phase II trial studies how well giving lenalidomide with or without rituximab works in     treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small     lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL).     Biological therapies, such as lenalidomide, may stimulate the immune system in different ways     and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block     cancer growth in different ways. Some block the ability of cancer to grow and spread. Others     find cancer cells and help kill them or carry cancer-killing substances to them. Giving     lenalidomide together with or without rituximab may kill more cancer cells.   "
142461|NCT01419782|"     The aim of this study is to investigate effects of femur exposed to unilateral vibration on     the rest muscle electrical activity of contralateral hip adductors and contralateral soleus     H-reflex in young adult men.      This study hypothesize that femur exposed to unilateral vibration may affect the rest muscle     electrical activity of contralateral hip adductors. Vibration can effectively enhance muscle     strength and power. Previous studies have shown that vibration increases muscle     electromyographic (EMG) activity. It has been showed that bone has an effect on the increase     in muscle EMG activity caused by vibration in healthy young adults in a study. In this study,     it was reported that vibrations-induced increases in muscle electrical activity of flexor     carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and the FCR     H-reflex was suppressed or depressed during vibration. This findings were reported to support     the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate     muscle activity.   "
142462|NCT01419769|"     The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this     study is being conducted under an Investigational Device Exemption (IDE) granted by the US     Food and Drug Administration (FDA).      The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study.     Up to 10 sites in the United States, European Community and/or Japan will enroll a total of     24 patients. A majority of the patients will be enrolled in the United States.      Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst     resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month     post-stent removal.   "
142463|NCT01419756|"     Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with     Tetralogy of Fallot following repair; a comparison study to cMRI.      The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to     calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical     repair.      Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical     sites.      The analyses will be the same for EDV and ESV. For either right ventricular volume, the     primary effectiveness measure is the % difference between VMS and cMRI results, i.e.     (VMS-cMRI)*100%/average of VMS and cMRI results. There will be two null hypotheses for the     primary analysis:      H0+: true mean % difference > 10% and H0-: true mean % difference < -10%      The observed mean % difference will be presented with 95% confidence intervals. The VMS right     ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and     H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+     and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the     overall type I error rate for both EDV and ESV is 0.05.   "
142464|NCT01419743|"     Historically, vitamin D has been considered to play a role solely in bone and calcium     metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse     health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose     metabolism. In the obstetrics literature, vitamin D deficiency has been linked to     preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data     from retrospective chart reviews have demonstrated a possible role of vitamin D in     implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization.     Patients found to be deficient in vitamin D were found to have significantly lower clinical     pregnancy rates when compared to patients who were replete in vitamin D levels. Currently,     there are no prospective clinical trials investigating the effects of vitamin D     supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The     investigators hypothesize that the vitamin D supplementation in patients found to be either     deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility     patients undergoing in-vitro fertilization.   "
142465|NCT01419730|"     This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet     that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and     without physical activity (walking and progressive resistance exercise), in treating bone     loss in women who have undergone treatment for breast cancer. The investigators would also     like to find out if the physical activity program improves cardiovascular fitness, energy     expenditure, muscular strength, muscle mass, and balance. One hundred five (105) subjects are     expected to take part in this study. The investigators don't know if bone loss in breast     cancer survivors should be treated differently than bone loss in other women.   "
142466|NCT01419717|"     This trial will facilitate access of denosumab for subjects with advanced cancer who have     participated in a denosumab phase 3 study until denosumab is approved and available for sale,     or until another mechanism is identified to provide denosumab to ongoing subjects.   "
142467|NCT01419704|"     The goal of this research study is to establish chimerism and avoid graft-versus-host disease     in patients with hemoglobinopathies.   "
142468|NCT01419691|"     The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat     patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or     prolymphocytic lymphoma (PLL).   "
142469|NCT01419678|"     This is a single center, observational study of posaconazole PK sampling in lung transplant     recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and     one 10ml blood sample for a total collection of 28ml of blood obtained over the entire study.     In addition, the investigators will collect medical record information and any excess BAL     samples available during the study (tests done as part of the patient's clinical care and the     samples would have been discarded once diagnosis was made).   "
142470|NCT01419665|"     The purpose of this study is to demonstrate comparability of the ORR in patients with     previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive     MabThera-treatment.   "
142492|NCT01419366|"     Objective:      To compare the rate and extent of release of the drug substance from the two tablet     formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and     the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of     at least 7 days.      Study Design:      Randomized, open label, two treatment, two period, two sequence, single dose, crossover study     in healthy human adult subjects   "
142493|NCT01419353|"     The purpose of this study is to determine if pretreatment with Estrogen can assist in the     planning and programming of In Vitro Fertilization treatments.   "
142471|NCT01419652|"     There are 24 million people with diabetes mellitus (DM) in the United States. Over one-third     of patients presenting for coronary angiography have known DM, and an additional 20% of     patients without known DM present with hyperglycemia on the day of coronary angiography.     Hyperglycemia in the setting of urgent and elective percutaneous coronary intervention (PCI)     is associated with a 40% relative increase in long-term mortality regardless of diabetic     status. Mechanisms linking periprocedural hyperglycemia to adverse outcomes are poorly     understood and the effects of treatment are unknown. This is a pilot study aimed at     determining the effectiveness, feasibility and safety of continuing long-acting hypoglycemic     medications on the morning of coronary angiography. Since hyperglycemia may cause increased     platelet reactivity, a secondary aim is to evaluate a possible mechanism of benefit of     periprocedural glycemic control on platelet activity. Patients with DM on hypoglycemic     medications undergoing coronary angiography will be randomized to either continue or hold     their clinically-prescribed long-acting hypoglycemic medications on the day of procedure.     Patients with and without DM will be randomized to either routine care or additional glycemic     control with the Yale insulin infusion protocol for 6 hours post-PCI. The primary endpoint of     this study will be mean blood glucose level at the time of arterial access in the hold versus     continue groups. Secondary endpoints will be mean blood glucose level at 6 hours post-PCI in     the Yale versus routine care groups and number of hypoglycemic events in the glycemic control     versus no glycemic control groups. The exploratory analysis assessing the effect of glycemic     control on platelet activity will guide further studies evaluating the translation of an     individual's platelet phenotype to the clinical risk of increased long-term mortality     following PCI. The outcomes for this study (glucose levels and platelet function) are all     measured during the hospital stay which averages 1 day.   "
142472|NCT01419639|"     This trial studies whether Everolimus is efficacious in treating neurofibromatosis 2.   "
142473|NCT01419613|"     The purpose of this study is to find out if a counseling program the investigators have     developed can help breast cancer survivors adopt a healthier lifestyle.   "
142474|NCT01419600|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     pharmacodynamics of increasing single doses of AZD8683 administered via inhalation   "
142476|NCT01419574|"     Background:      - Treatments for partly blocked carotid arteries are determined by a person s symptoms and by     tests that show how severe the blockage is. Studies show that the material that blocks an     artery is more important in spotting future problems than how tight the blockage is.     Researchers want to develop better imaging studies to find which blockages are more     high-risk.      Objectives:      - To use imaging studies to look at high-risk carotid artery blockages.      Eligibility:      - Individuals at least 21 years of age whose ultrasound exams show a major carotid artery     blockage.      Design:        -  Participants will be screened with a medical history, physical exam, blood and urine          tests, , an ultrasound scan and a magnetic resonance imaging (MRI) scan.        -  Participants will have ultrasound and other scans to obtain pictures of the arteries.          The scans will use drugs that may help study doctors get a better picture of the blood          vessels and blockages.        -  Participants will have followup phone calls yearly for 3 years. If a participant later          has surgery to remove the blockage, the surgeon will save part of it for future study.   "
142477|NCT01419561|"     Background:      - KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi     sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can have     severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen. People     with KICS may also be at risk of getting other cancers associated with KSHV. These cancers     include Kaposi sarcoma and lymphoma. Because KICS is a newly identified disease, more     information is needed on how the disease works and what can be done to treat it.      Objectives:      - To collect genetic and medical information from people with KSHV inflammatory cytokine     syndrome.      Eligibility:      - Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms that     resemble those caused by KICS.      Design:        -  Participants will have regular study visits. The schedule will be determined by the          study researchers.        -  Participants will provide a complete medical history and have a full physical exam.          Blood and urine samples will be collected as well.        -  People with KICS that requires treatment may get new experimental treatments. These          treatments may include antiviral drugs and chemotherapy drugs, depending on the nature          of the disease.        -  Participants will have imaging studies, such as chest x-rays and computed tomography          scans, to study the tumors.        -  Bone marrow and lymph node biopsies may be done to collect tissue samples for study.        -  Participants who have Kaposi sarcoma will have photographs taken of their lesions.   "
142478|NCT01419548|"     Background:      - Paclitaxel and carboplatin are two standard drugs that stop cancer cells from reproducing.     ABT-888 is an experimental cancer drug that may prevent cancer cells from fixing the damage     done by chemotherapy drugs. This may make the chemotherapy work better. More tests are needed     to determine the safety and effectiveness of ABT-888 plus chemotherapy. Researchers also want     to find the best dose of ABT-888 for people who have kidney or liver problems in addition to     cancer.      Objectives:      - To test the safety and effectiveness of ABT-888 plus carboplatin and paclitaxel in people     who have both cancer and kidney or liver problems.      Eligibility:        -  Individuals at least 18 years of age who have solid tumors that have not responded to          standard treatment, and who also have kidney or liver problems.        -  A small group of people with solid tumors and normal kidney and liver function may also          receive treatment for study comparison purposes.      Design:        -  Participants will be screened with a medical history and physical exam. They will have          blood and urine tests, tumor samples, tests of liver and kidney function, and imaging          studies. Participants will also provide a hair sample at the start of the study.        -  Participants will take one dose of ABT-888 1 week before starting chemotherapy. The two          chemotherapy drugs will be given on day 3 of a 21-day cycle. Participants will take          ABT-888 daily for the first 7 days of each cycle.        -  They will keep a diary to record medication doses and any side effects. They will also          have frequent blood tests and imaging studies. Participants will provide more hair          samples on day 3 of cycle 1 before and after having paclitaxel.        -  Participants will continue treatment for up to 18 weeks as long as the cancer stops          growing or shrinks and there are no serious side effects. Participants may have the          option to continue treatment after the study is done.   "
142491|NCT01419379|"     This study is designed as a multicenter, prospective and retrospective and descriptive     epidemiology study.      This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate     correlation of COPD disease progress and its exacerbation.      This study is designed with 6 months of subject enrollments, 12 months of retrospective     study, and 12 months of prospective study. Hence, each patient will be participating in the     study for 12 months, while the actual data collections from the patients will take a total of     24 months.      The statistical analysis of this study will be done twice, at the completion of 1 year     retrospective data collection and at the completion of next 1 year follow-up.      The 1st statistical analysis of retrospective study includes exacerbation rate, duration of     hospitalization for exacerbation and lung function test for the past 1 year from the     enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment     will be analyzed.      The 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation     rates, comparison of lung function test results, comorbidities, COPD assessments (CAT) and     COPD medications of retrospective and prospective studies for the 2 years as well as     mortality rate.   "
142479|NCT01419535|"     Background:        -  Metabolic syndrome is a name given to a group of factors that tend to occur together.          These risk factors include central obesity (extra weight around the middle of the body)          and high blood pressure and blood sugar levels. They also include low levels of HDL          (good cholesterol) and high triglyceride levels. A person is said to have metabolic          syndrome if they have three or more of the above risk factors. People with metabolic          syndrome are at increased risk for type 2 diabetes, stroke, and heart disease.        -  Cortisol, a hormone produced by the adrenal glands, is an important regulator of          metabolism. People with central obesity and metabolic syndrome may have higher than          normal cortisol levels that the body cannot regulate properly. Abnormal cortisol levels          may play an important role in metabolic syndrome. Mifepristone is a drug that blocks          cortisol. Researchers are interested in studying its effects on metabolic syndrome.      Objectives:      - To study the effects of short-term mifepristone treatment for metabolic syndrome.      Eligibility:      - Men and Women between 35 and 70 years of age are overweight or obese, and have abnormal     glucose and triglyceride levels.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests.        -  Participants will be admitted to the metabolic unit at the National Institutes of Health          Clinical Center for the first 3 days of the study:        -  Day 1: Body measurements (height, weight, waist, hip, and neck) and blood pressure          tests. Also, 24 hours of regular blood draws and 24-hour urine collection to monitor          regular daily cortisol levels.        -  Day 2: Glucose/insulin infusion test to measure blood sugar levels.        -  Day 3: Infusion of cortisol-like compounds and then regular blood draws for about 3          hours to evaluate how cortisol is metabolized.        -  At the end of Day 3, participants will receive mifepristone or a look-alike capsule to          take for 7 days at home.        -  After 7 days, participants will return to the metabolic unit to repeat the Day 1 and Day          2 study procedures. They will continue to take mifepristone.        -  One week after the second set of study tests, participants will return for a brief          physical exam and blood tests.        -  The study procedures will be repeated after 6 to 8 weeks, with the other study drug.   "
142506|NCT01419184|"     This was a real-world, prospective, open-label, multicenter study in which participants were     randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this     study is to compare infection-related hospital length of stay, along with a number of     participant-reported outcomes, between participants with complicated skin and soft tissue     infection treated with daptomycin and vancomycin.   "
142507|NCT01419171|"     The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary     Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery     lesion.   "
142480|NCT01419522|"     Background:      - Many people who have had a traumatic brain injury have difficulty walking. Training on a     treadmill is often used to help people with walking difficulties. Supporting a person s body     weight with a harness while using the treadmill can help improve walking skills in people     with brain injury. Varying the rate at which people walk on the treadmill may also help more     than walking at a constant rate. Treadmill training with body weight support or walking at     different speeds may improve walking skills in people who have had a traumatic brain injury.     More research is needed to see if one method is better than the other.      Objectives:      - To compare the effects of two types of treadmill training in people who have had a     traumatic brain injury.      Eligibility:      - People at least 18 years of age who have had a mild or moderate traumatic brain injury at     least 6 months ago and have mild or moderate walking difficulty.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          take a basic walking test (not on a treadmill).        -  Participants will be divided into two groups. The first group will have treadmill          training at a constant speed. The second group will have treadmill training at different          speeds. All participants will wear a support harness while walking on the treadmill.        -  At the first training visit, participants will have a gait assessment with different          tests of walking. Then they will have a treadmill walking session.        -  After the first visit, participants will return twice a week for 6 weeks for treadmill          training sessions (visits 3 through 12). They will also have grip strength and walking          tests.        -  At the end of 6 weeks, participants will have a final treadmill training session, and          will have a gait assessment exactly like the one in the first training visit.        -  At 6 months after the final session, participants will have a followup visit with a          final gait assessment.   "
142481|NCT01419509|"     RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the     disease has been disseminated.      PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor,     blood, and bone marrow samples from patients with rhabdomyosarcoma.   "
142482|NCT01419496|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about cancer and development of drug resistance in patients.      PURPOSE: This research trial is studying proteins that may promote chemotherapy resistance in     samples from patients with acute myeloid leukemia.   "
142483|NCT01419483|"     This study investigates if using a very low carbohydrate diet during combined chemotherapy     and radiation therapy is safe and if it can be tolerated by patients.   "
142484|NCT01419470|"     safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044     in premature ejaculation   "
142485|NCT01419457|"     This study is designed to determine the pharmacokinetics of favipiravir in volunteers with     hepatic impairment and in healthy control volunteers.   "
142486|NCT01419444|"     The purpose of this research is to determine whether treatment of voice disorders can be     provided just as effectively using telemedicine as it can using on-site, traditional therapy.     An exercise protocol for improving airflow with voicing has been demonstrated to be effective     in a prior UAMS investigation (Protocol 107454). These exercises are used as part of the     normal clinic routine at UAMS working with individuals with voice problems. The three     exercises used are: gargling with and without voicing; cup bubble blowing with and without     voicing; and, stretch and flow exercises, which involves the use of a piece of tissue to     provide visual biofeedback on the ability to use proper airflow with voicing. The purpose of     the exercises is to increase airflow and breathiness in the voice and reduce muscle tension.     In addition, patients will be taught to use a confidential voice or gentle voice during     speaking.      The investigators voice patients come from all over the state and many cannot return for     regular treatment. Developing a way to provide treatment to them closer to home could greatly     improve quality of care and quality of life. Twenty participants will participate for 12     sessions each. All participants will be evaluated at UAMS before and after treatment as part     of standard care and will, upon consent, be randomized to receive treatment via telemedicine     at an AHEC site or at UAMS Medical Center. Homework will be provided along with log sheets.     Results of airflow measures using an airflow-recording device (Viasys, KAY/PENTAX) pre- and     post treatment will determine whether telemedicine results are equal to results of     traditional, on-site treatment. The investigators hypothesize that results from treatment     using telemedicine will be equivalent to results for onsite, traditional treatment.   "
142487|NCT01419431|"     Pro-inflammatory responses following laparoscopic surgery.   "
142488|NCT01419418|"     Specific Aims: To delve into the complex phenomena of living with Peripheral Arterial Disease     (PAD), and to investigate the patients' perspective of the factors that affects their     decisions regarding management of their PAD.      a) Utilize a qualitative approach to uncover factors that patients perceive support the     management of their condition utilizing a purposive sampling of Peripheral Arterial Disease     patients.        1. To determine what they believe to be effective tools to support themselves to improve          their condition.        2. To determine from the patient's perspective if adherence to prescribed medical regimes          are important for them to improve their PAD outcomes.        3. To describe the patient factors of those who are self reported adherent compared to          those who are not or unable to their prescribed regimen.   "
142489|NCT01419405|"     In this experimental study on healthy volunteers we explored the effect of pregabalin alone     and in combination with remifentanil on acute experimental pain and ventilatory function.   "
142490|NCT01419392|"     The purpose of this study is to determine whether sildenafil citrate is effective in     improving uterine artery blood flow and oxidative stress in patients with unexplained     recurrent miscarriages   "
142521|NCT01418989|"     This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra     (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy     volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab).     The anticipated time of study duration is 28 days.   "
142494|NCT01419340|"     Objective:      To compare the rate and extent of release of the drug substance from the two tablet     formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and     the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of     at least 7 days.      Study Design:      Randomized, open label, two treatment, two period, two sequence, single dose, crossover study     in healthy human adult subjects   "
142508|NCT01419158|"     Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic     obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD     is not as rare as originally thought and undetected AATD may account for COPD in some     patients. This study was designed to evaluate the frequency of undetected AATD in a     population reporting to academic pulmonary function testing facilities who meet criteria for     the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and     offered free testing for AATD. The results will help identify the percent of those with COPD     who have undetected AATD.   "
142509|NCT01419145|"     A multicentre, open, randomized phase II study comparing a multimodal intervention (oral     nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer     care.   "
142496|NCT01419314|"     WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of     splints at night works to bring the pain down and help you sleep better (in people living     with HIV/AIDS related neuropathy).      HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the     Harris County Hospital District (HCHD).      WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two     treatment groups. In one group, you will be asked to wear leg splints at night and the other     you will wear the liners of the splints only.      You will be asked to answer questions about how well you sleep, how long you sleep, and about     your discomfort at the legs. The researcher will be there to help, but the investigators want     you to answer the questions on your own if you can. You will be asked to reach forwards     standing next to a wall and to walk for 6 minutes after that. The tests will de done in     random order. The sessions will be done at the beginning, at week three and week six. You     should finish all of the testing and questionnaires in an hour or less, for a total of three     hours over six weeks in the investigators clinic.      You will receive instructions on how to use the splints with liners or the liners alone at     home. You will be asked to wear them at night only for the next 6 weeks. Finally, the     principal investigator will contact you weekly by phone, to discuss issues of comfort and     your ability to adhere to the instructions provided.   "
142497|NCT01419301|"     This study focuses on stress, cognition, mood and fatigue and its effect on medication     compliance. Medication compliance is measured by the weight of discarded needles. The     investigators will be administering neuropsychological testing at baseline and the final     visit. The subjects will complete self-report assessments during their 8 weeks in the study.      Group A will have additional weekly phone support for meditation, while Group B will have     meditation training only.   "
142498|NCT01419288|"     Many people with a leg amputation have difficulty walking even after they have finished their     rehabilitation. The purpose of this study is to see if a large amount of walking practice on     a treadmill can improve functional abilities.   "
142499|NCT01419275|"     Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke     patients   "
142500|NCT01419262|"     Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods.     Vitamin D levels are alarmingly low in many North American children. Several health issues     have been linked with low vitamin D. These include colds caused by viruses and asthma     attacks. However, no study has determined whether vitamin D supplementation can reduce the     risk of these conditions in young children where they are most common and most severe.      The goals of this study are to determine whether wintertime high dose vitamin D     supplementation of preschoolers can prevent colds and asthma attacks. The investigators also     aim to work out how much money would be saved by the health care system and society if     preschoolers were routinely supplemented with Vitamin D during the winter. The investigators     believe that preschoolers receiving 'high dose' vitamin D supplementation during the     wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and     will be less likely to use the medical system and keep their parents away from work.   "
142501|NCT01419249|"     PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to     confirm that some genes can be used to predict how well a subject diagnosed with idiopathic     growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with     recombinant human growth hormone (r-hGH).   "
142502|NCT01419236|"     The purpose of this study is to see if testosterone solution 2% can impact symptoms of     ejaculatory dysfunction in men with low testosterone.   "
142503|NCT01419223|"     This is an exploratory qualitative interview study being conducted with a primary objective     of examining perceptions held by active military and veterans regarding help-seeking     attitudes and mental health beliefs which influence the decision to consent or decline     participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI)     clinical trials. Active duty military and/or veterans aged 18 years and older who consent to     participate (N = 50), or have recently declined participation (N = 50), in an INTRuST     affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited.     Participants who consent to participate in an INTRuST clinical trial (Group 1) will be     interviewed once at the beginning the of the clinical trial, and again following     participation in the trial. Participants who decline participation in an INTRuST affiliated     outpatient clinical trial (Group 2) will be interviewed once. For participants in both     groups, study participation will initiate within 1 month of referral to study. Total duration     of study participation is based on the specific clinical trial that the participant is     recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured     qualitative individual interviews will be conducted to carry out a thematic analysis of the     data exploring familial, social and institution-level constructs which may influence the     subjective experience of the research treatment process.   "
142504|NCT01419210|"     The purpose of this study is to find out if complementary and alternative medicines (CAM)     should be included with traditional therapy for women with ovarian cancer. Some of the     alternative medicines include non-traditional drug and herbal therapies along with dietary     and nutritional strategies. Only a few of these alternative medicines have been tested with     women with ovarian cancer.   "
142519|NCT01419015|"     A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the     20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral     delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to     evaluate the system performance as well as a post market clinical follow-up phase involving     long term follow-up of all patients to evaluate the safety of investigational devices up to 5     years.   "
142505|NCT01419197|"     This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy     and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's     choice in participants with metastatic or unresectable locally advanced/recurrent human     epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will     be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days     or treatment of the physician's choice. Participants continue to receive study treatment     until disease progression or unacceptable toxicity occurs. This study is also known under     Roche study protocol number BO25734.   "
142510|NCT01419132|"     High values of cardiac troponin (Ct) in acute heart failure (ADHF) identify patients (pts) at     higher risk and worsened prognosis. A Ct increase during therapy indicates the need for more     appropriate intervention, aimed at compensating cardiac disease and effectively minimizing     myocardial wall stress and subsequent cytolysis. This study evaluated the effects of an     intravenous high-dose of furosemide with or without small-volume hypertonic saline solution     (HSS)on myocardial cytolysis in ADHF pts.   "
142511|NCT01419119|"     The purpose of this study is to determine the efficacy of different doses of vitamin D in     persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.   "
142512|NCT01419106|"     This study is designed to determine if there is any relationship between performing an     abdominal ultrasound on patients who present with hypotension and their clinical outcomes (as     measured by 7, 30 day and discharge mortality).   "
142513|NCT01419093|"     The project is a two-arm randomized clinical trial to pilot the feasibility of a     communication training intervention for primary care clinicians, linked to a community     program referral, on use of the 5As to promote physical activity in underserved patients.   "
142514|NCT01419080|"     An estimated 8 million individuals in America are affected by peripheral arterial disease     (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD     can have a tremendous impact on patients' quality of life. It is also associated with high     rates of heart attacks and premature death. While there are a number of treatments, there     have been few previous studies that have prospectively examined treatment patterns for PAD or     sought to systematically identify opportunities to improve care. Most importantly, there have     been no rigorous studies examining the impact of the disease from patients' perspectives -     their symptoms, function and quality of life - as a function of different patient     characteristics and treatments. The PORTRAIT study (Phase II) will systematically document     the treatments and health status (symptom, function and quality of life) outcomes of 840 US     patients over the course of one year (assessments at baseline, 3, 6, and 12 months) from 10     centers to address these gaps in knowledge. It will illuminate whether disparities in     treatment or health status outcomes exist as a function of patients' age, gender, race,     socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field     and identify critical gaps in the way PAD is currently managed, including potential     disparities in care, so that the quality of care can be improved.   "
142515|NCT01419067|"     The goal of this study is to determine the feasibility and safety of treating patients with a     brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume     margin in combination with proton therapy. Proton therapy will be indicated for patients with     diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection).     Irradiated patients will undergo a series of evaluations designed to evaluate the effects of     proton therapy. Similar evaluations will be performed on patients treated with radical     surgery. Proton therapy will include 30 treatment fractions administered 5 days per week.     Weekly imaging will be a requirement to monitor for cyst expansion and target volume     deformation.   "
142516|NCT01419054|"     Healthcare associated infections increase morbidity and mortality among all hospitalized     patients, especially in those who are immunocompromised, in both developed and in countries     with limited resources. However, when resources are limited, infection prevention and control     measures are often overlooked by personnel and institutions. Hand hygiene has been shown     numerous times to be the most effective way to prevent infections in the healthcare setting.     In Unidad Nacional de Oncologia Pediatrica (UNOP) in Guatemala City, Guatemala, there have     been several infrastructural improvements and periodic education and promotion activities.     Still, acceptable hand hygiene compliance has not yet been sustainably achieved. The     investigators wish to study reasons why staff at UNOP do or do not practice hand hygiene when     it is indicated through the use of focus groups and interviews.   "
142517|NCT01419041|"     The present study is being conducted to evaluate whether or not severe renal impairment has     an effect on crizotinib Pharmacokinetics.   "
142518|NCT01419028|"     This study aims to characterize the natural history of patients with severe perinatal or     infantile onset HPP.   "
142520|NCT01419002|"     Net-Pac investigates if radiation prior to surgical resection improves survival in patients     with pancreatic head cancer without metastases.   "
142522|NCT01418976|"     This is a case series study evaluating the feasibility and dosage of Intensive Mobility     Training (IMT). Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury     (TBI) causing significant locomotor impairment, who meet these specific criteria, will be     recruited. Location and nature of neural insult will be determined by multimodal Magnetic     Resonance Imaging (MRI) exam. All participants will receive 3 hours of rehabilitation per day     for 20 days, focusing on gait and balance. Locomotion and balance will be comprehensively     tested prior to IMT, after 10 days of IMT, and then again after the full dose of IMT. This     study will determine the feasibility of this intervention in the population of TBI patients,     allow an estimate of effect size and provide initial information on possible neural     predictors of success. Furthermore the investigators will be able to determine whether the     dosage of 10 days is sufficient or whether significant improvements are made with 20 days of     the intervention.   "
142523|NCT01418963|"     This two-part, randomized, double-blind, placebo-controlled study will assess the safety,     pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of     RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each     subject.   "
142524|NCT01418950|"     Pregnant women who receive study counseling which includes gestational age specific written     information in addition to the verbal counseling will have better knowledge of problems and     outcomes of prematurity than women who receive standard counseling which consists of only     verbal counseling.   "
142525|NCT01418937|"     This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV     vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and     received a placebo in the HPV-001 (NCT00689741) study.   "
142526|NCT01418924|"     The aim of this study is to determine whether plasma sclerostin levels is affected by sex     hormones during menstrual cycle. Blood samples will be obtained at the beginning (between     2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Serum     sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only     one investigator   "
142527|NCT01418911|"     This study will expand the understanding of factors associated with adherence to self care     and the diabetes control among diabetes type 2 patients. The theoretical framework of the     study incorporates central variables from two theoretical models: a cognitive model of health     behavior - Health Belief Model, and the Stress and Coping model. The study is innovative in     its focus on the association between the patient's attachment style and adherence to self     care and diabetes control, a topic less studied among diabetes patients, in addition to     cognitive, social and emotional variables. Further emphasis is upon a comparison of the study     model between males and females.   "
142528|NCT01418898|"     This study will follow a randomized, double-blind, placebo-controlled, parallel-group design     to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve     nutrient status and iron deficiency in young children compared to an unfortified control     beverage.   "
142529|NCT01418885|"     SIVD is characterised by extensive cerebral white matter lesions (WML) and lacunar infarcts     in deep grey and white matter structures. The relationship between SIVD and cognition is     unclear, in part because of methodological inconsistencies across studies.      Diffusion tensor imaging (DTI) is a non-invasive water diffusion technique and can be used     for quantitatively measuring the degree and directionality of the displacement distribution     of water molecules. 1H magnetic resonance spectroscopy (1H-MRS) is a valuable tool for the     assessment of several biochemical compounds in the brain in vivo, such as N-acetylaspartate     (NAA), myoinositol (mI), Choline (Cho) and Creatine (Cr). There were few reports considering     the relationship among MRS, DTI and cognitive impairment of SIVD. Combining MRS with DTI may     provide valuable information about the pathophysiological changes underlying DTI     abnormalities and help us to better understand the SIVD process. It has been proposed that     the pathogenesis of SIVD related to cerebral small vessel disease caused by various     mechanisms. Inflammation plays an important role in the pathogenesis of SIVD. The examination     of inflammatory markers in relation to VaD might be benefit to early treatment.      In this study we applied neuropsychological tests, conventional MRI scanning, DTI, 1H-MRS     techniques and inflammatory markers to estimate neuropsychological profile and white matter     characteristics of imaging in patients with SIVD. Moreover, the relationship between WML and     cognitive function impairment was also investigated. It could be possible to gain reliable     data which is benefit to early diagnosis and treatment of cognitive impairment in SIVD.   "
142530|NCT01418872|"     AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º     grade in the community of Madrid.      DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children     of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate     exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an     experimental group that the investigators organized a concert teaching focused on messages     cardio, a second group or control group to which they will host a healthy breakfast as it has     been offering the Community of Madrid .      MEASUREMENTS: The primary end result is the increase of correct answers on a standardized     test to be administered before and after the activity.      Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall     weight and center from before the intervention at 6 months of it.   "
142531|NCT01418859|"     The purpose of the research is to evaluate the effect of additional chemotherapy in     postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion     or tumor thrombi in the vascular system).   "
142532|NCT01418846|"     The purpose of this study is to investigate the intra-saliva penetration of voriconazole in     different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive     and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in     children, ambulatory patients and in patients in whom blood drawing is difficult.   "
142533|NCT01418833|"     The first goal of this study is to map all the subtherapeutic, therapeutic and     supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second     objective is to optimize and validate guidelines for dose modifications in patients with too     low or high plasma concentrations and to investigate if the same guidelines can be used in     different patient populations.   "
142534|NCT01418820|"     Visual field areas, which are not absolutely blind, are hypothesized to have some residual     capacities that constitute their potential for vision restoration. Vision restoration can be     achieved by varies methods including behavioral training and electrical brain stimulation     such as transcranial direct current stimulation (tDCS) and repetitive transorbital     alternating current stimulation (rtACS) which are able to influence the excitability and     activity of cortical areas.      It is hypothesized that transorbital alternating current stimulation (tACS) can improve the     residual field of vision in patients with post-chiasmatic lesions.   "
142535|NCT01418807|"     We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when     transvaginal rather than transumbilical specimen extraction is accomplished. This would be     due to the avoidance of a 10-mm port in the umbilicus. Visual analogue scale score of     post-operative pain will be obtained and patients satisfaction will be asked at the 2-month     postoperative visit.   "
142536|NCT01418794|"     Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our     previous study showed that polymer-free rapamycin-coated stents brings dose-dependent     reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials     aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary     artery disease.   "
142537|NCT01418781|"     We will study whether the health care costs and health utilities differ in patients with gout     and those without gout and whether they differ between those with more severe versus less     severe gout   "
142538|NCT01418768|"     The purpose of this study is to determine if there is a change in the CAT-score after an     inpatient rehabilitation of three weeks and if it correlates with other common parameters.   "
142539|NCT01418755|"     Recently an articular cartilage repair has been given much attention in the orthopaedic     field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a     delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains     proliferative and chemoattractant growth factors. The objective of the present study was to     determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.   "
142542|NCT01418716|"     The TRANSIT program is a program to TRANSform InTerprofessional clinical practices to improve     cardiovascular prevention in primary care. It addresses priorities in primary care relevant     to the Chronic Care Model (Wagner 2001): self-management support, delivery-system design, and     management of clinical information.      The program includes :        -  a case manager to coordinate and provide care and follow up;        -  clinical protocols and tools to support interprofessional and systematic follow up;        -  training for clinicians;        -  patient's personalized cardiovascular health booklet;        -  tools to promote group sessions for patient education on cholesterol, hypertension, and          diabetes.      The general OBJECTIVE of this trial is to evaluate and compare two STRATEGIES for     implementing the TRANSIT program in Family Medicine Groups (FMGs):        1. facilitation, and        2. passive diffusion.      Passive diffusion is the usual strategy where clinicians implement an intervention program by     themselves. Facilitation is a strategy whereby a facilitator provides support to a team of     clinicians to help them introduce the changes required to implement the program into     practice.      The hypothesis is that facilitation will be more efficacious to implement the program than     passive diffusion:        -  it will enhance the provision of cardiovascular preventive care;        -  it will enhance interprofessional collaboration;        -  it will enable more efficaciously the implementation of new clinical processes;        -  it will improve patient clinical outcomes;        -  it will cost more in the short term, but will have positive economic impact in the long          term;        -  there will be less undesired effects of all types related to implementation.      To test the hypothesis, we assess the efficacy of the implementation strategies to enhance     interprofessional collaboration and better support patients in the management of their     conditions. Impact on provision of care, interprofessional collaboration, clinical processes,     and patient clinical outcomes (values, therapeutic targets, and lifestyle habits) will be     evaluated. Moreover, the implementation cost related to each strategy will be estimated.      We complement the trial with qualitative methods to document the perceptions of clinicians,     facilitators, patients and members of the family regarding the TRANSIT program, the     implementation strategies and the observed changes in the clinical practices and outcomes.   "
142543|NCT01418703|"     In this protocol the investigators plan to demonstrate the feasibility of a modular insulin     management system based on continuous glucose monitoring and targeted towards the avoidance     of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is     designed to challenge the insulin management system with meals and mild exercise, so as to     demonstrate its capacity to avoid large glucose excursion with changing metabolic state. This     system is designed to both        -  monitor the meal boluses of the patient and correct it in case of observed/predicted          under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and          subjective knowledge of the meal amount, a precise understanding of the subject's day to          day insulin treatment, continuous glucose monitoring, and past insulin injections;        -  predict and avoid hypoglycemic events, based on continuous glucose reading and past          insulin injection.      The investigators plan to enroll 12 adult Type 1 Diabetes Mellitus (T1DM) patients (expected     retention 10/12) and compare glucose control performances under two treatments: standard vs.     the new insulin management system. The protocol will include a total of 6 admissions per     subject (4 out-patients and 2 in-patients): screening, effort test, CGM insertion 1,     inpatient 1, CGM insertion 2, and inpatient 2. During the 24h inpatient admissions, the     patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage of     these events will vary depending on the chosen treatment, each subject will be exposed to     both studied treatments (repeated measure design).The order of treatment during the inpatient     admissions will be randomized.   "
142544|NCT01418690|"     Adequate tissue oxygenation is required for effective white blood cell function and     bactericidal activity. Decreased tissue oxygenation is a risk factor for perioperative wound     infections. Regional anesthetic techniques result in a functional sympathetic block and may     increase tissue oxygenation. The purpose of this study is to evaluate changes in tissue     oxygenation using a non-invasive Near-infrared spectroscopy (NIRS) device. The current study     will evaluate changes in tissue oxygenation following regional anesthetic techniques     (peripheral nerve blockade and neuraxial techniques such as caudal block) in pediatric     patients).      Regional anesthesia will induce a sympathetic blockade and improve tissue oxygenation.   "
142545|NCT01418677|"     This is an open-label non-randomized study in subjects with advanced or metastatic solid     tumors who are no longer responding to available therapy. HALAVEN will be administered to     subjects on Days 1 and 8 of a 21-day cycle.   "
142546|NCT01418664|"     We hypothesized that vitamin D supplementation during pregnancy can prevent adverse pregnancy     outcome.   "
142547|NCT01418651|"     Participants will undertake a 12-week, open-label study of milnacipran in a     well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and     older to investigate the short-term efficacy and safety of this drug in the elderly     population. The investigators hypothesize that milnacipran will be effective in treating     fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the     absence of pre-existing blood pressure abnormalities and other serious medical conditions.   "
142548|NCT01418638|"     Objective There is growing evidence showing a relation between depression, metabolic     syndrome, diabetes, cardiovascular disease (1), serum lipid profile (2,3) and body weight     (4), as well as the effects of some of the antidepressant medications on these various     conditions and profiles.      The aim of the study is to examine the influence of antidepressant medications on the     metabolic profiles (5) of patients suffering from Major Depressive Disorder (MDD).      Group of patients:      30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.      Research Design and Methods:      Research duration will be 8 weeks. Patients meeting the inclusion criteria will be recruited     after being diagnosed with MDD and having undertaken the HDRS. A follow-up HDRS will be taken     at weeks 4 and 8. The psychiatric evaluation will be held by a resident in psychiatry.      The following metabolic parameters will be examined at base-line and at the end of the 8     weeks:      Weight, height, waist circumference, body mass index (BMI: (Weight in Kg/(Height in     meters)2), sitting blood pressure (after 3 minutes of sitting).      Serum lipid profile (performed in Ziv hospital's chemistry lab): Low density lipoprotein     cholesterol, High density Lipoprotein cholesterol, Triglycerides, Total cholesterol,     Apolipoprotein level (Apo AI, Apo B, Apo E, Apo AII).      Fasting glucose and insulin blood levels, in order to evaluate insulin-release and     resistance, according to the following formulas:      Insulin Resistance:      HOMA IR=Fasting glucose (mg/dL)x Fasting insulin (mmol/L)/405      Insulin Release:      HOMA-β={360xfasting insulin (mmol/L)}/{glucose(mg/dL)-63} Serum oxidative stress parameters     according to the F2-Isoprostane kit will be measured.      Malonylaialdehyde (MDA) content in serum will be analyzed by the thiobarbituric acid reactive     substances assay, which measures malondialdehyde equivalent (13). Conjugated dienes will be     measured at 234nm (14, 15).   "
142549|NCT01418625|"     Objective:      The Bioequivalence studies were performed to compare the rate and extent of release of the     drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride     Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR®     (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc.,     USA.      Study Design:      Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose     Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test     formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule     (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers   "
142784|NCT01415544|"     The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based     method for measuring glucose concentration relative to invasive blood reference measurements.     The initial phase of the study will be focused on procurement of the data needed to develop a     robust, accurate calibration. The second phase will be focused on performance evaluation of     the system.   "
142550|NCT01418612|"     Objective:      The Bioequivalence studies were performed to compare the rate and extent of release of the     drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride     Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR®     (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc.,     USA.      Study Design:      Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose     Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test     formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule     (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers   "
142551|NCT01418599|"     Objective:      Primary objective of the present study was to assess the relative bioavailability of two     formulations of Extended Release Alfuzosin 10 mg under Fed conditions, in healthy adult male     subjects after an oral administration with 7 days washout period.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
142552|NCT01418586|"     Objective:      Primary objective of the present study was to assess the relative bioavailability of two     formulations of Extended Release Alfuzosin 10 mg under Fasted conditions, in healthy adult     male subjects after an oral administration with 7 days washout period.      Study Design:      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence     Study   "
142553|NCT01418573|"     The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as     compared to a meal constructed along the lines of the WHO dietary recommendations.   "
142554|NCT01418560|"     The purpose of this study is to observe the incident of uremia and dialysis requirement after     renal sympathetic modification using THERMOCOOL® catheter in patients with chronic renal     failure, and evaluate safety and efficacy of the intervention.   "
142555|NCT01418547|"     Objective:      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER     Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA     under fed condition. Dosing periods were separated by a washout period of 8 days.      Study Design:      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects   "
142556|NCT01418534|"     Objective:      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER     Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban,     USA. Dosing periods were separated by a washout period of 8 days.      Study Design:      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects   "
142557|NCT01418521|"     The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to     show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in     terms of safety and effectiveness as the commonly used albumin based solution for volume     replacement after the surgery.   "
142558|NCT01418508|"     The purpose of this study is to determine whether low protein diet and very low protein diet     supplemented keto-/amino acid is effective in preventing the progression of chronic kidney     disease (CKD , stage 3b and 4).   "
142559|NCT01418495|"     This research trial is studying how Ch14.18 acts in the body of younger patients with     high-risk neuroblastoma. Studying samples of blood from patients with cancer receiving     Ch14.18 may help doctors learn more about how this drug is used by the body to develop better     ways to give the drug to potentially improve its effectiveness and lessen its side effects.   "
142595|NCT01418027|"     The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase     of physical activity are recommended as an effective approach for the prevention and     treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In     the present study we aim to compare the effect of intensive and conventional exercise     interventions on NAFLD.   "
143344|NCT01408134|"     The primary objective of this study is twofold:        1. To define inter-reader variability of myocardial viability imaging within the first pass          and delayed enhancement cardiac CT perfusion imaging        2. To evaluate DE CT image quality using a consensus DECT protocol   "
142560|NCT01418482|"     The investigation is designed as an open, non-controlled, post-marketing investigation.     Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will     be included. The subject is allowed to have more than one burn on the body but only one     should be included in the investigation. Each subject will be followed/assessed according to     normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired     treatment effect is obtained if that occurs earlier. All dressing changes will be done     according to clinical routine and will follow the IFU (instruction for use). All dressing     changes will be registered in a dressing log. Additional compression bandaging, gauze wrap,     or such are allowed and should be reported as well   "
142561|NCT01418469|"     Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA):     leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However,     the effects of BCAA intake on protein metabolism during exercise are less clear. When BCAA     were supplied as single amino acids, without other amino acids and/or carbohydrates, no     effects were observed on protein kinetics. On the other hand, ingestion of BCAA during     running appeared to reduce the catabolic effect of running on muscle protein metabolism.     These experiments were all performed with mixtures of the BCAA with or without carbohydrates     but not in the form of complete meals with food protein as a basis. Therefore, it is still     unknown whether a protein meal, containing a substantial amount of BCAA is beneficial during     exercise by inducing an anabolic effect.      Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein.     Therefore, it is hypothesized that milk-based proteins are a better and more physiological     source of BCAA during exercise and will lead to more protein anabolism. Most of the available     studies have been carried out in young and fit humans but there are hardly any data are     available in the increasing population of the elderly. Therefore it is still unknown whether     a BCAA rich protein meal can enhance the anabolic effect of exercise in older individuals.      Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic     disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important     health care problem. COPD is the fourth leading cause of death and will be the third leading     cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease,     associated with alterations in intermediary metabolism. Substantial disturbances have been     found in BCAA (and related) metabolism in these patients at rest and during exercise. It     might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein     meals in patients with COPD at rest and during exercise.   "
142785|NCT01415531|"     The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of     therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with     stage 1 or stage 2 essential hypertension.   "
142786|NCT01415518|"     Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD)     patients.   "
142562|NCT01418456|"     The overall objective is to investigate whether antibiotics in the treatment of clinically     clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence     of infection and therefore lead to improved outcomes This is a single centre study in which     patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic     Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without     clinical signs of infection will be invited to take part and will express their willingness     to take part in the study by signing a consent form.        -  All patients will be treated and followed up in the DFC at King's College Hospital.          Patients will be randomised into two groups: an antibiotic group and a control group.        -  The antibiotic group will receive standard treatment along with antibiotics.        -  The control group will have standard treatment alone.        -  Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks.        -  Patients will be removed from the study if they develop clinical signs of infection or          if their ulcer heals prior to 20 weeks but will be followed up via routine practice for          eventual outcomes   "
142563|NCT01418443|"     Objective:      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release     Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of     Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7     days.      Study Design:      randomized, open label, two treatment, two period, two sequence, single dose, crossover study     in healthy human adult subjects   "
142564|NCT01418430|"     The purpose of this study is to determine the safety of the combination of CHOP plus     daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.   "
142565|NCT01418417|"     Objective:      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release     Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of     Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7     days.      Study Design:      randomized, open label, two treatment, two period, two sequence, single dose, crossover study     in healthy human adult subjects   "
142566|NCT01418404|"     In literature review, thermal stimulation (TS) intervention is effective in facilitating     upper extremity functional recovery in stroke patients. In addition, several functional MRI     studies have indicated that thermal stimuli promoted activation in the premotor and motor     cortices of healthy participants. These imply the possibility of TS in cortical     reorganization. However, there were no studies exploring the relationship of the TS     intervention and cortical reorganization. By the functional recovery of stroke patients,     findings of brain image and brain mapping, it could enhance the understanding the TS     influences on brain reorganization. Regarding with clinical application of the TS     intervention for improving functional performance of upper extremity in participants with     stroke, the best parameters of TS intervention in clinical practice have not been decided.     Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute,     chronic) undergoing TS intervention with different parameters. Functional scales, kinematic     data, brain image were taken in several timelines as outcome measures.   "
142567|NCT01418391|"     Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It     had been reported the effect of post-operative pain control in minor abdominal surgery, such     as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of the     pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus, the     purpose of this study is to investigate the effect, such as analgesic effect, hemodynamic     stability, and post-operative morphine consumption, of TAP block in minimal laparotomy.   "
142591|NCT01418079|"     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the     brain. It is similar to the device that measures the level of oxygen in the tip of the     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the     forehead that both emits and detects the amount of light absorbed. This study will determine     how accurate the device is by comparing the displayed value on the monitor with blood samples     taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In     order to test the device over a suitable range, the level of oxygen within the blood will be     reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the     equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy     volunteers.   "
142568|NCT01418378|"     This study will compare two very similar designs of knee replacement device. One device     (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified     to enhance/accommodate higher flexion. The original device has been in widespread clinical     use with excellent results since 1996 and this study will determine whether the design     modifications of the newer device add further value. The newer device has been in clinical     use with good short-term(unpublished) outcomes since becoming commercially available in     January 2009.      Achieving higher knee flexion may be required for cultural reasons or by the increasingly     younger, more active patient population undergoing knee replacement today. In addition to     promoting flexion, it is also possible that this design change may help the knee replacement     to last longer than traditional implants in patients who achieve higher flexion. Therefore,     the study will compare the two devices in terms of survivorship, flexion and other measures     of the success of a total knee replacement (range of motion, knee-related quality of life,     activity and generic quality of life) over the short-term.      A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and     aged 50-75 years will be included at UK/international hospitals.      Study duration is 2 years and patients will complete standard knee outcome scores plus     radiological evaluation.      Subjects would receive one of the study devices regardless of their involvement in the study,     and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and     follow-up care will be as per the care they would receive outside of the study.   "
142569|NCT01418365|"     Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered     alone & in combination with MMX® Mesalazine/mesalamine   "
142570|NCT01418352|"     The goal of the current trial is to determine efficacy and safety of Once-weekly aripiprazole     in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.   "
142571|NCT01418339|"     The goal of the current trial is to determine efficacy and safety of Once-weekly aripiprazole     in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.   "
142572|NCT01418326|"     Knowledge gap: Does the choice of anaesthetic affect outcome for cancer surgery?      Aim: To retrospectively examine possible associations (Cox Multiple Regression) between     survival from breast-, colorectal-, or skin cancer and the choice of hypnotic used during     surgery, ahead of a prospective randomised controlled trial.      Hypotheses: One- and five-year survival will be significantly higher after radical breast-,     colorectal-, or skin cancer surgery in patients given the intravenously administered hypnotic     propofol than in patients given the inhalational hypnotic sevoflurane.      Method: To merge two registers, of which one holds demographic- anaesthetic-, and surgical     data from 6 303 patients operated on at the three mentioned anatomical locations at the     Central Hospital in Vasteras, Sweden during a twelve year period (1998-2009). Of these     minimum 4 500 operations would be due to cancer. This register is unique, in that it contains     both types of anaesthesia. The other register holds survival data (date and cause of death),     stored at the Regional Oncologic Center in Uppsala.      The choice of anaesthetic will be validated by controlling each patient's anaesthetic paper     file, concomitantly with extraction of details from anaesthesia and surgery, such as the     functional classification of each patient (according to American Association of     Anesthesiologists), co-morbidity, duration of anaesthesia and surgery, amount of blood loss     and possible transfusion.      Current knowledge: Different anaesthetics have opposite effects on the immune system and on     the DNA. There is a well-established association between the state of the immune system and     cancer growth, which in turn will influence survival. There is also an association between     DNA damage and cancer development. Inhalational anaesthetics, e.g. sevoflurane, act     pro-inflammatory, and they are also proven to be genotoxic. Propofol is anti-inflammatory and     anti-oxidative, and it is not genotoxic.      Objective: Strengthen the hypotheses, and get statistics for a proper power calculation in     advance of a multi-centre, prospective, randomised, controlled trial.      Impact: General anaesthesia is an indispensable part of radical cancer surgery. Undesired     effects from anaesthesia on survival has strong relevance for the over all cancer treatment.   "
142573|NCT01418313|"     The purpose of this study is to develop and validate novel magnetic resonance imaging (MRI),     dynamic contrast enhanced (DCE)-MRI and positron emission tomography (PET)/MR techniques for     the detection and risk stratification of patients with atherosclerosis.   "
142574|NCT01418300|"     The purpose of this study is to improve first line Helicobacter pylori eradication rate and     to compare the sequential versus conventional triple therapy.   "
142575|NCT01418287|"     A study to characterize children and adults with influenza like symptoms and to determine     risk factors for severe disease and death among those with H1N1.   "
142576|NCT01418274|"     This single-arm, open-label, non-randomized study will evaluate the effect of     danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in     healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and     escitalopram. The anticipated time of the study is 6 weeks.   "
142577|NCT01418261|"     The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized,     controlled study of the safety and effectiveness of renal denervation in subjects with     uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity     Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal     surface of the renal artery.   "
142578|NCT01418248|"     Heart Failure with Preserved Ejection Fraction (HFpEF) and Pulmonary Hypertension (PH) can be     diagnosed noninvasively by Exercise Echocardiography (ExE) and Cardiopulmonary Exercise     Testing (CPX) as compared with gold standard invasive hemodynamic assessment.   "
142579|NCT01418235|"     Sub-Saharan Africa is the region most affected by the global Human Immunodeficiency Virus     (HIV) epidemic. A vaccine is the most promising preventive approach against new HIV     infections. The purpose of this study is to evaluate the safety and immunogenicity of 4     experimental preventive HIV vaccine regimens in HIV-uninfected adults in South Africa.   "
142580|NCT01418222|"     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety     of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in     patients with metastatic colorectal cancer.   "
142581|NCT01418209|"     The primary objective of this study is to determine the efficacy of both low-dose oral (by     mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in     reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR     to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is     currently considered the most established but also a controversial therapy. 17-ß-estradiol is     a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine.     Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a     substance containing no medication.   "
142592|NCT01418066|"     In the present study the investigators are trying to evaluate the effect of Murraya koenigii     leaves, Punica granatum and Curcuma which is administered to the patients in a combined form     as tea. This study will help to evaluate the effect of these preparations scientifically in     improving the IBS symptoms.   "
142582|NCT01418196|"     Metabolites of dietary phosphatidylcholine- choline and trimethylamine N-oxide (TMAO)- were     recently identified as being associated with myocardial infarction in a case-control study.     The latter TMAO is a gut-microflora-derived choline metabolite that has been shown to be a     potent risk factor for cardiovascular disease (CVD). This pilot study seeks to use     information derived from a dietary questionnaire in children to test the association of     dietary choline intake to plasma levels of TMAO as well as the relationship between plasma     choline levels and components of atherogenic dyslipidemia (increased triglycerides and small     LDL, and reduced HDL cholesterol). An ancillary goal of this study is to build on existing     programs of community outreach to local Oakland/Berkeley minority communities, and to develop     an infrastructure for family-based and community participation in clinical research across     the full age spectrum and among diverse populations. This pilot study will examine the     association of dietary choline intake assessed by food frequency questionnaires to biomarkers     of CVD risk in 40 children (> 7 years of age) and their parents as there is no information     regarding this relationship in children. The results of this pilot study will form the basis     for a proposal to carry out a randomized intervention trial to directly test the effects of     dietary choline intake on plasma TMAO and lipoprotein levels. Ultimately, better     understanding of the relationship between dietary choline intake and CVD risk factors may     facilitate the formulation of appropriate dietary choline recommendations in children and     adults.   "
142583|NCT01418183|"     This study will assess the efficacy and safety of levobupivacaine for postoperative pain     control in patients received orthognathic surgery. In this split-mouth study, each side will     be randomized to receive 1) 5ml 0.5% levobupivacine, 2) 2.5ml 0.5% levobupivacaine, or 3)     placebo. One shot of these agents will be delivered by nerve block to maxillary and     mandibular branches of trigeminal nerve before the incision was made. The degree of     postoperative pain will be evaluated daily by visual analog scale for up to 3 days. The     anticipated time on study is 1 year, and the target sample size is 40 individuals.   "
142584|NCT01418170|"     Specific Aim 1:      To determine if the effect of cervical spinal manipulation on the pressure pain thresholds in     a myofascial trigger point in the infraspinatus muscle can be enhanced and/or extended after     a second cervical spine manipulation is given during a single subject visit.      H1: There will be a statistically significant increase in pressure pain thresholds in the     myofascial trigger point in the infraspinatus muscle after the second cervical spine     manipulation, as compared to the first.      Specific Aim 2:      To determine if the effect of two cervical spinal manipulations on pressure pain thresholds     in a myofascial trigger point in the infraspinatus muscle will be present at 48 hours     follow-up. Data will be collected for descriptive purposes and hypothesis generation.   "
142585|NCT01418157|"     Acute mountain sickness is a common ailment in people venturing over 2500 m altitude.     Pilgrims to high altitudes are at an added risk since they are unaware and they gain height     faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of     acute mountain sickness. There are no randomized controlled trials that have studied     protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies     regarding this matter.      This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus     placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent     that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will     be randomly assigned for 3 days and participants will be assessed at 3 stations.      This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be     the first RCT done in this issue.      The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent     to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the     incidence and severity of acute mountain sickness.   "
142586|NCT01418144|"     The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane     (TAP) block as a part of a multimodal postoperative pain management after laparoscopic     surgery on colon.   "
142587|NCT01418131|"     Ulcerative Colitis (UC) is a life-long incurable disease with remissions and exacerbations.     Inflammation confined to the rectum occurs in a quarter of patients and can be extremely hard     to treat. Many medications have been tried in order to control the inflammation, but they do     not always work. One of the newer medications is the immunosuppressing medication, tacrolimus     that has been shown to be effective in UC when taken orally. Unfortunately, the oral use of     this medication can have numerous serious side effects. In order to overcome these side     effects, the use of topical rectal tacrolimus has been examined. Pilot studies in ulcerative     proctitis (inflammation confined to the rectum) resistant to conventional therapies have     demonstrated a clinical remission in 75% of patients and although the medication was well     absorbed through the lining of the bowel, the levels in the blood were very low and no     serious side effects were reported. The findings suggest that this preparation is indeed     effective for inflammation in the distal bowel and that the method of administration reduces     side effects. Further work, however, now needs to be undertaken to validate the original     findings.   "
142588|NCT01418118|"     Following surgery to remove tumours of the head and neck, patients undergo reconstruction     with free flaps - tissue that is taken from elsewhere in the body and given a new blood     supply by attaching it to vessels in the neck. Following this type of surgery, patients often     need medication to maintain their blood pressure in the intensive care unit. The effect of     these drugs on the transplanted tissues is unknown. This study investigates the effects of     four commonly used drugs on free flap perfusion.   "
142589|NCT01418105|"     The research is about a prospective study conducted in patients suffering from dysphagia and     cervical spine disorders and how they are interrelated. Three questionnaires have been given     to patients with neurologic deficits, the first of these investigates the occurence of     dysphagia in the three stages of swallowing, the second looks into the quality of life     following a stroke or other neurologic damage and the third analyses how cervical spine     disorders can affect every day life. After the bedside examination, VFSS or FEES, the     patients are submitted to swallowing and cervical resistance exercises in fixed time periods     after their hospitalisation. The results will be collected and evaluated using the     statistical programme SPSS.   "
142590|NCT01418092|"     The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered     daily to adults with OIC.   "
142596|NCT01418014|"     The advances in treatment to prevent maternal HIV transmission to neonates have been     groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is     now small. Subsequent improvements in the treatment of HIV-infected infants and children have     been equally remarkable, ensuring that most previously infected American children have     survived and are approaching adolescence. In addition, the number of HIV-infected adolescents     worldwide is growing substantially in both resource-poor countries and in countries with     increasing levels of health care. Therefore, there is a global cohort of children who have     been living with HIV infection since birth who are aging into adolescence. Little is     definitively known about the impact of HIV infection and its treatment on the maturation     process in these children.      AMP is a prospective cohort study designed to define the impact of HIV infection and     antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection.     Domains to be investigated include growth and sexual maturation, metabolic risk factors for     cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment,     language, hearing and behavioral function, and sexually transmitted infections (STI).   "
142597|NCT01418001|"     The purpose of this study is to see the effects, good and/or bad, of the drug combination of     gemcitabine, docetaxel and pazopanib on sarcoma. This is a phase Ib-phase II clinical trial.     The goal of a phase Ib part of the clinical trial is to confirm a dose of the drugs that is     safe. The investigators determine this by closely checking for side effects that the patient     may experience.   "
142733|NCT01416207|"     Rationale for the Study:      The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic     (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be     used to support registration of Avonex in China.      Study Design:      This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly     injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood     samples will be collected with the first and fourth injections of Avonex, and a sparse blood     sample will be collected with the second and third injections of Avonex.   "
142598|NCT01417988|"     This study investigates the prevention of early mortality in patients initiating     antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB     reside. Many published studies have shown a surprisingly high proportion of all patients     initiated on ART dying within 6 months (8-26%) with increasing risk with decreasing CD4 T     cell count. The majority (median 70%) occur in the first 3 months with the greatest     proportion of deaths due to previously undiagnosed tuberculosis (TB). The investigators will     enroll patients from 4 geographically diverse countries (Gabon, Mozambique, South Africa, and     Uganda) in a randomized open label clinical trial targeting a population of people with high     mortality risk; patients with CD4 T cell count < 50 cells/μl and body mass index (BMI) < 18     kg/m2. Severely immunocompromised patients with low BMI in the intervention arm will receive     presumptive anti-TB 4-drug chemotherapy and subsequently initiate ART within 2 weeks compared     to ART alone. The main objective is to measure and compare early mortality in the group     presumptively treated for TB in addition to ART. Other sub-objectives are to determine the     predictors of early mortality and the causes of death by autopsy (traditional and verbal), to     determine if presumptive anti-TB treatment affects viral suppression with ART, and to assess     incidence rates and characterize drug toxicity in patients dually treated. Because of the     high rates of TB co-infection in sub-Saharan Africa in the HIV-infected, the investigators     expect that patients presumptively treated for TB in addition to HIV will have a lower     mortality rate than patients receiving ART only. This trial is expected to be of great public     health benefit and generalisability.   "
142599|NCT01417975|"     Female and male smokers will complete questionnaires and smoking behavior will be examined.     After abstaining from smoking for approximately 18 hours, they will be randomized to a     moderate intensity exercise groups or passive sitting group. Smoking satisfaction and smoking     behavior will be assessed following treatment.      The hypotheses detailed below are specific to the randomization of participants into the     following 2 groups:        1. Moderate exercise (Experimental condition; MEG)        2. Passive sitting (Attention control condition; PSG)      Hypothesis 1: A bout of moderate intensity exercise will be associated with decreased smoking     satisfaction after a temporary period of abstinence compared to a control condition.      Hypothesis 2: Smoking topographic measures will mediate the relationship between a bout of     moderate intensity exercise and smoking satisfaction.   "
142600|NCT01417962|"     The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a     minimally invasive approach for post-mortem assessment of the fetus, infant and child, with     similar detection rates for anomalies and determination of the cause of death.      This will be achieved by acquiring a database of whole-body, post-mortem MR images in     approximately 400 fetuses, infants and children, over a 3 years period. Images will be     acquired on a dedicated 1.5T research MR scanner. MR images will be reported by an expert     group of paediatric radiologists, and compared, in a blinded fashion, with reports from     conventional autopsy performed by expert perinatal and paediatric pathologists. Importantly,     the post-mortem information will be assessed with reference to the needs of the parents,     referring clinicians and HM Coroners. The detection of central nervous system abnormalities     will be assessed separately.      The study will be performed across two sites: A dedicated children's hospital (Great Ormond     Street Hospital) and a teaching hospital, with large obstetric, fetal and neonatal     departments (University College London Hospital), which are linked academically by University     College London.      Co-ordination of the project will be managed by a steering committee, which will ensure     accurate collation and comparison of the data.   "
142601|NCT01417949|"     The purpose of this study is to compare the early versus deferred initiation of     antiretroviral combination therapy consisting of tenofovir, emtricitabine and     atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining     illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).   "
142602|NCT01417936|"     The trial is designed as a multi-center, open label Phase 2 trial that investigates the     efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck     (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor     receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to     that therapy. It is believed that Sym004 has the potential to induce tumor responses and     provide a superior treatment option to subjects with advanced SCCHN.      Symphogen was the sponsor for planning/conducting and reporting results for this trial.   "
142655|NCT01417234|"     The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System     for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose     will be to compare the prospective patients to retrospectively treated acute trauma wounds to     further evaluate efficacy and safety.   "
142656|NCT01417221|"     The purpose of this study is to observe the incident of composite cardiovascular events after     renal sympathetic modification using THERMOCOOL® catheter in patients with essential     hypertension, and evaluate safety and efficacy of the intervention.   "
142603|NCT01417923|"     Vitamin D3 is produced in the skin following exposure to UVB light from the sun or artificial     sources, and occurs naturally in a small range of foods.More recently, several reports     underlined the impact of vitamin D on the prevalence and consequences of inadequate vitamin D     intake and the research supporting its benefits for alleviating chronic musculoskeletal pain     and fatigue syndromes in outpatients. Experts have recommended that vitamin D inadequacy     should be addressed in all patients with bone or joint pain, myalgia, fibromyalgia, or     chronic fatigue syndrome. It appears that soothing the daily musculoskeletal pain by     supplementation of vitamin D may be a simple, well tolerated, and cost-effective modality.      Aim of study:      To study the potential therapeutic effects of vitamin D supplementation on patients with     persistent musculo-skeletal pain. Clinicalparameters, visual analog score,short form McGill     Pain Questionnaire,patient global perceived effect, quality of life assessed by SF-36     Questionnaire and laboratory parameters, the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF     and prostaglandin E will be assessed.   "
142734|NCT01416194|"     This observational cohort study is being conducted to further characterize selected adverse     events of interest among a patient population with osteoporosis who are prescribed     bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized     clinical trial setting. The study will compare the rates of the selected clinical events     among the three treatment groups.   "
142604|NCT01417910|"     Over 3000 people each year undergo bypass operations to their lower limbs, and these     operations carry significant risks with approximately 1 in 20 of these people dying in     hospital, and another 1 in 20 having a heart attack.      Assessment of these patients in order to stratify their risk of both dying and having     significant complications aid in improving their care, enable better utilisation of scarce     critical care resources, and allow us to give patients better information on which to base     consent.      Aims The aims of the project are to assess the feasibility of exercise testing this group of     patients both with cycle and arm exercise, and to identify markers of outcome in this group.      Methodology This is a prospective observational study designed to test the hypothesis that a     combination of cardiopulmonary exercise testing and blood tests provides prognostic value on     outcome measures after surgery for lower limb revascularisation      Subjects will have 2 exercise tests, one arm and one cycle, prior to surgery at their     preoperative assessment appointment. From these tests we will measure how much work patients     can do, how much oxygen they are able to use, and when the heart is unable to deliver enough     oxygen to the cells. In addition they will have blood samples taken prior to the operation     (brain natriuretic peptide), and on days 1 and 3 (troponin I) after the operation to look at     cardiac markers of damage.      This data will be used to see if we can predict those patients that have both short and long     term complications, and also to see whether the different forms of exercise testing are     comparable, or if one type is superior.      Expected outcomes We expect that through a combination of exercise testing and blood test we     will be able to identify patients at increased risk of complications after surgery. We also     expect to find that arm exercise will be a more feasible and informative test that cycle     exercise.   "
142605|NCT01417897|"     The planned HERMES study is to investigate and compare the effects of Insulin Glulisine,     Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and     several clinical and laboratory markers of postprandial endothelial cell function,     sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary     parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a     biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are     missing, it is not possible to calculate sample size and statistical power. Therefore the     goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations     and estimations on the probability of success of HERMES.   "
142606|NCT01417884|"     Molecular targets on platelets are pivotal for the development of new pharmacological     substrates for platelet inhibition and to better understand the impact of platelet-mediated     inflammatory processes for the progression of heart disease, such as coronary heart disease     and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have     underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic     efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19     encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs.     Therefore, a prospective patient cohort with exact phenotypic characterisation according to     standardized protocols is necessary to enable the examination of the clinical relevance of     potential molecular targets. A supplementary provision of high quality bio-material enables     the systematic examination of new promising platelet-biomarkers in cardiovascular disease,     which already have produced significant results on experimental animal and/or cell biologic     models. Primary objective of the central project is to establish a prospective cardiological     cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated     Biobank and thus to review the clinical significance of potential targets deriving from     individual subprojects within the research group (German Research Council KFO 274/1-1) to     safeguard a translational approach.   "
142607|NCT01417871|"     Aims: We evaluate the efficacy of the Active Body Control (ABC) Program for weight     reduction in patients with metabolic syndrome.      Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie     diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized,     clinical trial 60 patients will be treated according to the ABC program and 60 control     patients will receive standard therapy.   "
142608|NCT01417858|"     The purpose of this study is to compare the intra-ocular (IOP) control efficacy between     brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).   "
142609|NCT01417845|"     The purpose of this randomized clinical trial is to compare the effect of moderate versus     high intensity exercise training on physical fitness and physical function in patients with     type 2 diabetes. The research hypothesis is that high intensity exercise training will be     superior to moderate intensity on such outcomes in individuals with type 2 diabetes.   "
142610|NCT01417832|"     The purpose of this study was to compare with a clinical randomized controlled split-mouth     design study the changes in the therapeutic effect of infiltrating versus sealing proximal     caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion     progression, evaluated by radiographic techniques.   "
142611|NCT01417819|"     Rigorous and regular follow-up is essential to successful management of childhood cataract,     but it is often ignored by parents and especially difficult to be delivered in China, such an     average-medical-resource-limited country.      Health programmes that use mobile communication technologies are emerging with the aim of     strengthening health systems.      The investigators aimed to assess whether mobile phone short message service (SMS) for     parents of cataract children involved in the Childhood Cataract Program of Ministry of Health     of China (CCPMOH) improved follow-up adherence and detection rate of the timing of surgery,     postoperative complications and necessary replacement of glasses.   "
142612|NCT01417806|"     The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type     1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these     SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF     which is known to contribute to SCLC proliferation. Topotecan is approved for second line     therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents     should yield greater antitumor activity.   "
142613|NCT01417793|"     According to WHO database, an average of 540 million people worldwide dies from smoking     related diseases every year. The use of tobacco products may reduce the average life     expectancy of about 15 years. The data of 2009 from Department of Health Bureau of Health     showed 38.57% male adults and 4.75% female adults smoked in Taiwan. Studies about smoking     rate within prison inmates were between 64-91.8%, which was over 3 times than the general     population. Smoking cessation can lower the risks of smoking related health problems. Two     thirds of smokers in Taiwan once tried smoking cessation but the success rate was about 5%     every year.      In view of high smoking rate within prison inmates in Taiwan, Agency of Correction, Ministry     of Justice announced a smoking cessation program for inmates in April 2010. The purpose of     this study was to investigate the effects of this program and the difference of cessation     success rate between various interventional methods, using questionnaires for smokers and     smoking cessation clinics database.   "
142617|NCT01417741|"     The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus     standard therapy on postoperative nausea and vomiting in pediatric patients undergoing     tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either     the treatment or the control group.        1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the          induction of anesthesia        2. Control Group: Standard anti-emetic therapy only      This study will monitor nausea, retching, and vomiting events both directly after the surgery     as well as the next day via a follow-up phone call to the parents of the study participant.   "
142618|NCT01417728|"     The aim of the study is to analyze the mechanism of action of infliximab at the     endomicroscopic level and to analyze mucosal healing - i.e. structural and functional changes     in the mucosa in IBD patients - and associated processes such as permeability and bacterial     invasion of the mucosa. In this study the role of the above mentioned parameters and further     the establishment of endomicroscopic scores will serve to define new prognostic markers in     view of long term remission upon infliximab treatment.   "
142619|NCT01417715|"     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,     Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and     histologic features including patterns of inflammation, crypt abscesses and granulomas.     Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for     gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an optical biopsy     of the gastrointestinal mucosa during the endoscopic procedure.      The main objective of this study is to determine endomicroscopic features of mucosal healing     in patients with IBD.   "
142620|NCT01417702|"     Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders,     Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and     histologic features including patterns of inflammation, crypt abscesses and granulomas.     i-Scan use an endoscopic image from the video processor and reconstruct virtual images in     real time, resulting in an improved contrast of the capillary patterns and enhancement of the     mucosal surface (so called virtual chromoendoscopy).      The main objective of this study is to determine endoscopic features of mucosal healing in     patients with IBD and to compare these features to clinical and histological data in order to     establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing     as a parameter of remission and relapse.   "
142621|NCT01417689|"     Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of     glaucoma patients have problems instilling their eyedrops. These problems include not hitting     the eye, spending many drops to get a single successful instillation and bottle     contamination.      The present study will evaluate the effect of encouraging patients to put their eyedrops     using one of 2 techniques, randomly assigned, to determine which is more successful at     instilling the eye drop into the eye while spending the least amount of drug.      In one of the techniques the patient instills the eye drop with their eyes open in the     inferior cul de sac. In the other technique the patient instills the eye drop with the eyes     closed near the inner canthal region.      Patients will be randomized to encouragement to use the drops with either of the techniques.     Encouragement will take place over a visit where they will be subjected to:        -  Baseline evaluation of eye drop instillation using their usual technique.        -  Short (2-5 minute) educational session session for the assigned technique.        -  Followup evaluation immediately after the educational session.   "
142622|NCT01417676|"     This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study.     The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation     with simultaneous integrated boost to prostate in high risk prostate cancer patients.   "
142623|NCT01417663|"     Healthy but sedentary aging leads to increased morbidity and mortality of cardiovascular     disease. This is partly due to the accumulation of Advanced Glycation Endproducts (AGEs) and     the stiffening of the myocardium and arteries. New medication has been developed to break     these AGE-crosslinks to improve cardiovascular compliance. The positive influence of regular     physical activity is well known for cardiovascular disease and aging. Therefore, what is the     most effective intervention, physical exercise and/or new medication AGE-crosslink breakers,     in improving the cardiovascular and cerebrovascular compliance and improving the endothelial     function in healthy sedentary elderly.   "
142657|NCT01417208|"     The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound     therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment     of lower extremity diabetic, venous and mixed aetiology leg wounds.   "
142624|NCT01417650|"     Temporomandibular disorder (TMD) is the major cause of nondental pain in orofacial area.     Laser therapy can be considered as one of the most popular methods of pain relief in TMD     patients. The special features of laser light such as coherence, monochromaticity, and     collimation can result in the ability of laser light to modify cellular metabolism, increase     tissue repair and reduce edema and inflammation. The effectiveness of low level laser therapy     in reducing the signs and symptoms of temporomandibular joint disorders has been investigated     in a few studies. But, in most of the previous studies the etiology of TMD has not been     considered in patient selection. Furthermore, there are some controversies in the results of     these studies. According to our data, there is no study evaluating the effects of low level     laser therapy on patients having TMJ osteoarthritis.      The aim of this study is to evaluate the effectiveness of low level laser therapy in     improving osteoarthritis of temporomandibular joint and also to evaluate the long term     effects of laser therapy on the morphology of the joint.   "
142664|NCT01417117|"     Intracerebral hemorrhage (ICH) occurs when small arteries in the brain rupture due to     weakening by age, high blood pressure, and/or elevated cholesterol. In addition to artery     rupture, recent data suggests that patients with ICH are also at risk for developing     occlusion of arteries during the acute phase, called ischemic strokes. Data suggests these     ischemic strokes can negatively impact patient outcomes. Diffusion weighted imaging (DWI) is     a sequence on Magnetic Resonance Imaging (MRI) that is a sensitive marker for ischemic     strokes in the brain. In this proposal, our primary aim is examine prospectively the effect     DWI abnormalities have on functional outcomes in patients with ICH. Our hypothesis is that     the DWI abnormalities found on MRI of the brain lead to worse functional outcomes in patients     with ICH   "
142625|NCT01417637|"     Temporomandibular disorders (TMDs) are the major cause of non-dental pain in orofacial area.     Laser therapy can be considered as one of the most recent treatment approaches in the field     of physiotherapy. The special features of laser light such as coherence, monochromaticity,     and collimation can result in the ability of laser light to modify cellular metabolism,     increase tissue repair and reduce edema and inflammation. Several studies demonstrated     successful results regarding the use of low level lasers in releasing pain of musculoskeletal     conditions, but there are also contradictory reports in this field, and the clinical     effectiveness of this treatment modality has been debated in some review articles. A few     studies evaluated the efficacy of low level laser therapy in the treatment of     temporomandibular disorders and the associated myofacial pain. There are remarkable     variations in the methodology of these researches and some reported insufficient data     regarding the physical properties of the laser used. The aim of this study is to evaluate the     effectiveness of low level laser therapy in improving the sign and symptoms of patients     suffering from myofacial pain syndrome.   "
142626|NCT01417624|"     Heart failure is a common, costly, disabling and potentially lethal condition. Despite well     recognised and proven drug therapies, many patients remain breathless on exertion. A special     pacemaker (cardiac resynchronisation therapy) may help improve symptoms of breathlessness and     survival by restoring coordinated beating of the heart. However, despite careful planning and     the knowledge of the most appropriate selection criteria, up to a third of patients do not     get the desired beneficial effects after the pacemaker has been implanted.      The implantation of the special pacemaker requires three leads (wires) to be inserted within     the heart. Currently this is undertaken under X-ray guidance. Some patients may have scarring     of the heart muscle due to previous heart attacks or their underlying condition. The X-ray     technique cannot see this and therefore the doctor may implant the lead in such an area of     scar tissue. Cardiac magnetic resonance imaging (CMR) can demonstrate these areas of scar.     The study aims to investigate whether CMR can better predict where the wires should be     placed. The CMR pictures will be taken before the patient has the special pacemaker     implanted.   "
142627|NCT01417611|"     Image-enhanced endoscopy in screening colonoscopy        1. useful tool for detecting subtle epithelial lesions        2. useful tool for predicting real-time histology of epithelial lesions. Among          image-enhancing techniques, i-SCAN is new developed and the practical usefulness of          i-scan for screening colonoscopy has not been investigated yet.   "
142628|NCT01417598|"     Balance control, physical activity and health related quality of life will be assessed before     and after a 10 to 12 weeks training program as well as 6 and 12 months thereafter in 200     elderly (>60) with balance problems (100 with osteoporosis, 100 with Parkinson's disease).     Osteoporosis subjects will be assigned to 3 groups (balance training, balance training and     Nordic walking, or control group) and Parkinson's subjects to 2 groups (balance training or a     control group). The training will be progressive and specific incorporating dual task     exercises (directly related to an increased risk of falling). Clinical and laboratory gait     and balance measures as well as questionnaires will be used to assess physical function and     quality of life. An earlier study, investigating this training program in healthy elderly     with balance problems showed that the training was well-tolerated and effective, with a     significant increase in balance control, physical function and activity. In this study, we     expect that an improvement in balance function, physical activity and health related quality     of life, which will lead to a decreased number of falls, prevent and/or postpone incidence of     a hazardous fall and thereby reduce the burden on the health care system. Our model for     functional balance training and outcome methods will expand techniques and tools available to     physical therapists and health care scientist treating and evaluating patients with loss of     balance function. Elderly receiving therapy with the goal to improve or recuperate physical     function and balance will benefit from this project.   "
142629|NCT01417585|"     This is a cluster randomized controlled trial in which client-centered rehabilitation of     activities of daily living (CADL) will be compared to usual rehabilitation of activities of     daily living (UADL) regarding participation in activities of daily living, independence in     activities of daily living and life satisfaction during the first year after stroke. In     addition use of health services, caregiver burden and significant others' life satisfaction     will be studied. Study design, methods and power analysis are based on our previous pilot     study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and     Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: < 3     months after stroke, dependent in at least two activities of daily living, understand     instructions and referred to a participating rehabilitation unit. Data are collected at     baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In     addition qualitative longitudinal studies will be performed in order to describe how CADL is     integrated.   "
142630|NCT01417572|"     The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling     surgery.   "
142658|NCT01417195|"     The objective of this study was to compare the fertilization rate between the combination of     Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered     subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART).     Additionally the study assessed subjects' ability to mix and store the combination of Menopur     and Bravelle and to assess safety of the Menopur and Bravelle combination.   "
142631|NCT01417546|"     Background:      - The experimental drug NHS-IL12 may help the immune system become more active and kill     cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to     cause less severe side effects than other anticancer drugs, and may be more effective. More     research is needed to test NHS-IL12 in people who have solid tumors that have not responded     to treatment.      Objectives:      - To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have     not responded to standard treatments.      Eligibility:      - Individuals at least 18 years of age with solid tumors that have not responded to standard     treatments.      Design:        -  Participants will be screened with a medical history, physical exam, blood and urine          tests, and imaging studies.        -  Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the          hospital for at least one day to be monitored with frequent blood tests.        -  Participants will have periodic blood samples taken before treatment and during the          first week after treatment for the first two cycles. They will then have blood samples          taken before treatment for the rest of the cycles....   "
142632|NCT01417533|"     Background:      - Hereditary inclusion body myopathy (HIBM) is a disease that causes walking difficulties and     increasing muscle weakness. It usually develops in young adults (between 20 and 30 years of     age), and affects arm and leg muscles. HIBM is caused by mutations in a gene that may affect     how the muscles function. Researchers want to learn more about the causes, symptoms, and     effects of HIBM.      Objectives:      - To collect genetic and medical information from people with hereditary inclusion body     myopathy.      Eligibility:      - Individuals between 18 and 80 years of age who have hereditary inclusion body myopathy and     do not use a wheelchair. - Participants must be willing to stop any current treatment of HIBM     while enrolled in the study.      Design:        -  Participants will be screened with a medical history, physical exam, and neurological          exam.        -  At the first visit, participants will have the following tests:        -  Questionnaires about the impact of HIBM on daily activities, mood, and quality of life        -  24-hour urine collection        -  Blood samples        -  Heart function tests        -  Muscle strength and endurance tests, including walking        -  Imaging study of the muscles        -  Participants will return for followup visits at 6, 12, and 18 months. They may be asked          to return for a final visit at 24 months. Not all tests will be performed at each visit.        -  Treatment will not be provided as part of this protocol.      For more information, visit our website: http://hibmstudy.nhgri.nih.gov/   "
142633|NCT01417520|"     Background:      - Erdheim Chester Disease (ECD) is a very rare disease in which abnormal white blood cells     start growing and affect the bones, kidneys, skin, and brain. ECD can cause severe lung     disease, kidney failure, heart disease, and other complications that lead to death. Because     ECD is a rare disease, found mostly in men over 40 years of age, there is no standard     treatment for it. More information is needed to find out what genes can cause ECD and how     best to treat it.      Objectives:      - To collect study samples and medical information on people with Erdheim Chester Disease.      Eligibility:      - Individuals 2 to 80 year of age who have been diagnosed with Erdheim Chester Disease.      Design:        -  Participants will be screened with a physical exam and medical history.        -  Participants will have a study visit to provide samples for study, including blood,          urine, and skin tissue samples. Participants will also have lung, heart, and muscle          function tests; imaging studies of the brain, chest, and whole body; a treadmill running          stress test; an eye exam; and other tests as needed by the study doctors.        -  Participants will be asked to return for a similar set of tests every 2 years, and to          remain in contact for possible treatment options.   "
142634|NCT01417507|"     This trial studies the natural history of brain function, quality of life, and seizure     control in patients with brain tumor who have undergone surgery. Learning about brain     function, quality of life, and seizure control in patients with brain tumor who have     undergone surgery may help doctors learn more about the disease and find better methods of     treatment and on-going care.   "
142635|NCT01417494|"     RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan     hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells     to grow and spread. Others find tumor cells and help kill them or carry tumor-killing     substances to them. Giving bevacizumab together with combination chemotherapy may be a better     way to block tumor growth. It is not yet known whether combination chemotherapy is more     effective when given together with or without bevacizumab in treating patients with     colorectal cancer.      PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab     together with first-line chemotherapy and to see how well it works in treating older patients     with metastatic colorectal cancer.   "
142636|NCT01417481|"     The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5     g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis,     as compared with placebo. During all of the study children will receive their usual treatment     for cystic fibrosis.   "
142637|NCT01417468|"     The purpose of this study is to determine whether learning styles are effective in the     treatment of traumatic brain injury (TBI) in an educational environment.   "
142638|NCT01417455|"     Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are characterized by chronic     systemic inflammation and share common pathogenic pathways. In both diseases, cytokines like     TNF (tumor necrosis factor) and interleukin (IL)-17, known for their pro-inflammatory and     osteoclastogenic effects, are relevant players, however, while RA is characterized by bone     erosions, AS favors bone overgrowth. Understanding this paradox may hold the key for a better     management of both diseases. Our hypothesis is that there are differences in the cellular     environment and intracellular signaling between AS and RA. To test this hypothesis we will     evaluate the cytokine milieu, the kinetics of bone cells differentiation and their activity     in untreated and immunosuppressed RA and AS patients. We will also perform the same     observations in patients exposed to targeted treatments.   "
142639|NCT01417442|"     The purpose of this study is to determine whether BRAF V600E mutation in our patients with     papillary thyroid cancer has an association with poor prognosis.   "
142640|NCT01417429|"     This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female     smokers will first have two 4-day treatment periods, in which they will be randomized to     galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day     washout period. During the first 3-days of each treatment period, smokers will have daily     clinic visits, where they will receive study medications and any adverse effects from study     medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period,     subjects will refrain from smoking for approximately 2.5 days, until the experimental session     on Day 4. Compliance with non-smoking will be verified by CO levels < 10 ppm. During the     experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously     in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced     among subjects such that equal number of subjects will receive saline first or nicotine     first. Following each saline and nicotine treatments, physiological, subjective and cognitive     measurements will be obtained   "
142641|NCT01417416|"     The relevance of BBB and IB permeability changes as a major precipitating cause for cognitive     and digestive dysfunction in the military stress setting.   "
142646|NCT01417351|"     Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis     Medical Center are currently conducting a study on the effects of vitamin D supplementation     during pregnancy on maternal health and immune function. The investigators believe that     vitamin D supplementation at levels greater than the current recommendation is beneficial for     maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency     during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due     to an imbalance in immune function at the placenta. This randomized, double-blind study is     designed to test this hypothesis. Pregnant women who participate in the study receive either     400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The     investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28     weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The     investigators are also collecting data on clinical parameters, such as blood pressure and     glucose tolerance.   "
142647|NCT01417338|"     1. To characterize the demographics and clinical course of the patient population diagnosed          as having WHO group I pulmonary arterial hypertension and WHO group IV pulmonary          hypertension due to chronic thromboembolic pulmonary hypertension        2. To describe real-world outcome of Chinese patients with WHO group I pulmonary arterial          hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic          pulmonary hypertension        3. To evaluate differences in patient outcomes according to classification subgroup        4. To identify clinical predictors of long-term survival        5. To assess the relationship between targeted therapies for pulmonary arterial          hypertension and patient outcomes   "
142648|NCT01417325|"     The registry study is to obtain the state of the art of the percutaneous coronary     intervention state treatment for coronary heart disease in Beijing area of P.R.China in a     real world. The data are collected from 48 hospitals in Beijing area using an uploading     system through internet.   "
142649|NCT01417312|"     This study aims to investigate metabolic effects of a standardized green tea extract,     containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis     patients.   "
142650|NCT01417299|"     The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201     has been reported to induce neuronal regeneration in animal models. Evaluation will be done     by combining clinical /behavioral assessment with fMRI studies.   "
142651|NCT01417286|"     This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery     works in treating patients with breast cancer. RT uses high energy x rays to kill tumor     cells. Giving RT after surgery may kill any remaining tumor cells   "
142652|NCT01417273|"     The aim of this study is the comparison between the effects of supplementation with 25000 IU     preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for     next 6 months on disease activity and progression in patients with Multiple Sclerosis.   "
142653|NCT01417260|"     Oxytocin is a hormone that is released in response to distension of the cervix and uterus     during labor, and after breast feeding as a result of nipple stimulation. In addition to     oxytocin facilitating birth and breastfeeding, oxytocin has a number of effects on maternal     behavior including bonding, social recognition, anxiolysis, sexual arousal.      The role of oxytocin in pain modulation has recently been highlighted. Intranasal or     intrathecal (spinal) administration has been found to impact pain modulation. The     administration of intravenous oxytocin has not provided effective analgesia because oxytocin     is unable to pass to your brain. The role of breastfeeding on analgesia is poorly     investigated, which is why we are carrying out this study.   "
142654|NCT01417247|"     The purpose of this study is to observe the incident of composite cardiovascular events after     renal sympathetic modification using THERMOCOOL® catheter in patients with metabolic     syndrome, and evaluate safety and efficacy of the intervention.   "
142659|NCT01417182|"     Prostate cancer is the most common cancer among men in the United States. Through early     detection and improved local therapies a large number of men will be cured. The clinical     needs include early detection, accurate initial staging and detection of local recurrence or     metastases in order to permit application of the most appropriate therapy. Therapeutic     monitoring and prognostic assessment are equally important. Imaging can play an important and     crucial role in meeting these clinical needs.      Positron emission tomography (PET) imaging has gained an important role in the clinical     management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific     membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18     positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging     studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer     cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission     tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic     properties that will represent an advance in imaging prostate cancer. This initial phase I     study will determine the biodistribution, pharmacokinetics, and prostate specific tumor     uptake in patients with metastatic prostate cancer.   "
142660|NCT01417169|"     This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic     stem cell transplantation. Micafungin is administered until confirmation of neutrophil     engraftment or treatment failure.   "
142661|NCT01417156|"     Primary objective of this study is to investigate the long-term tolerability and safety     profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary     Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).      Secondary objectives are to assess effects on some efficacy criteria during long term     treatment with BIBF 1120 on top of pirfenidone.   "
142662|NCT01417143|"     The purpose of this phase II study of TKI258 (Dovitinib) in adenoid cystic carcinoma is to     evaluate the efficacy of TKI258 (Dovitinib).   "
142663|NCT01417130|"     The Alzheimer's Disease Anti-inflammatory Prevention Trial - Follow-up Study (ADAPT-FS) will     continue observations of the declared primary outcomes of the Alzheimer's Disease     Anti-inflammatory Prevention Trial (ADAPT) in the cohort previously established for that     trial.   "
142711|NCT01416493|"     This is a proof of concept study asking if alkaline phosphatase injections can reduce acute     inflammation in rheumatoid arthritis patients.   "
142712|NCT01416480|"     The aim of this clinical trial is to evaluate the antitussive effect of Theobromine capsule     300mg in patients with acute bronchitis.   "
142665|NCT01417104|"     This study is being done to assess the effectiveness of short term (~9 months)     Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic     and abdominal aorta. This will be checked by comparing before and after therapy magnetic     resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for     hypertension but in this study is used for a new indication. Recent studies with animals have     shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study,     the investigators would like to evaluate whether the investigational drug Aliskiren, which is     not FDA approved for this indication has the same beneficial effects in people with     atherosclerotic disease.   "
142666|NCT01417091|"     This is a randomized, open label intra-patient dose escalation study to evaluate safety and     tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis     imperfecta (OI).      Pharmacodynamic effect will be determined by serological biomarkers and radiologic     assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.      Twelve to 15 patients will be enrolled.   "
142667|NCT01417078|"     The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray     following a single dose in epileptic patients experiencing a seizure episode.   "
142668|NCT01417065|"     The goal of this clinical research trial is to study the effects of the FDA-approved drug,     temsirolimus, using a new type of clinical study design called a Phase 0. This type of     study may be able to predict if a drug can affect cancer and may be able to prevent     potentially useful study drugs from being discarded before they are fully tested.      The purpose of the study is not to treat the cancer, but to help improve general cancer     treatment knowledge.   "
142669|NCT01417052|"     The primary objective of this study is to determine the safety of LX3305 in a dose escalation     compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).   "
142670|NCT01417026|"     The main objective of this study is to determine the safety and therapeutic potential of     intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when     paired with a computer game intervention that is designed to enhance face perception skills.   "
142671|NCT01417013|"     The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to     moderate dry eye subjects.   "
142672|NCT01417000|"     Test the safety, immune response and efficacy of GVAX pancreas vaccine (with     cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone     in adults who have failed or refused prior treatment for metastatic pancreatic cancer.   "
142673|NCT01416987|"     This prospective study will collect safety information from more than 600 patients treated     with Pergoveris®.      During the Post-Marketing Surveillance (PMS) period, data about the patient´s background,     patient's medical history, Pergoveris® indication, prior infertility medication, Pergoveris®     treatment status, concomitant drugs, all adverse events (regardless of the causal     relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) will be     collected for study purposes.      The post marketing surveillance is based on all cases treated with Pergoveris®.   "
142674|NCT01416974|"     The purpose of this Phase I study is to test the safety and effect of specially prepared     cells collected from the patients called modified T cells. We want to find a safe dose of     modified T cells for patients who have disease remaining after initial chemotherapy. We also     want to find out what effects these T cells have on you and your leukemia.   "
142675|NCT01416961|"     This study is needed to assess the feasibility of integrating this therapy with current     treatment regimens. If this study shows success a formal phase II test study to conduct     feasibility will be the next step. The first dose level chosen for this study is 66Gy of     radiation to the tumor between LET and standard photon therapy. This dose is the current     standard of care for stage III . If this dose is found to be feasible then the dose of LET     will escalate to the total dose of 74Gy.   "
142676|NCT01416948|"     This study will evaluate the efficacy of methylphenidate and galantamine in the treatment of     persistent cognitive symptoms associated with posttraumatic stress disorder (PTSD) and/or     traumatic brain injury (TBI).   "
142677|NCT01416935|"     The purpose of this study is to determine whether anti arrhythmic medication, specifically     Amiodarone, is required during the first three months post surgical ablation.      Hypothesis: Amiodarone will not be required during the first three months as verified by no     increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm     at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to     include patients' first follow up with cardiologist at approximately 3 months post surgery.   "
142678|NCT01416922|"     The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the     management of women who have received an LSIL Pap report to determine whether the test can     predict which women will progress to more serious cervical disease and which women do not     have to be monitored as closely.   "
142679|NCT01416909|"     The purpose of this research is to evaluate the effectiveness of the Constipation Treatment     Protocol and to test whether management according to dose of constipation-inducing     medications or according to on-going assessment is most effective.   "
142680|NCT01416896|"     Our preliminary studies have demonstrated that an innovative new design of the hemodialysis     venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the     patient) with three jets is superior to the standard venous needle because it decreases the     velocity and turbulence of the blood when compared with the standard venous needle, it is     more efficient in the removal of toxins from the blood, and it is safe and effective. More     importantly, our preliminary studies suggested that the new needle causes less damage to the     dialysis vascular access and to circulating blood cells and less inflammation and oxidative     stress. These will decrease medical complications, the high cost of care and death in     dialysis patients. The current study will corroborate the finding of previous studies.   "
142681|NCT01416883|"     The purpose of this study is to investigate the presence or absence of oral mucosal     absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects   "
142682|NCT01416870|"     The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation     with Casodex commercial tablet (80mg) in Japanese healthy male subjects   "
142683|NCT01416857|"     Aim 1: To develop and validate an Emergency Department(ED) Rasch Disability Diagnostic Tool     (RDDT).      Hypothesis:        -  Rasch modeling will provide an instrument with better measurement properties, including          increased reliability and validity compared to currently available ED measure of          disability (MOD).      Aim 2: To conduct a randomized controlled trial to evaluate the utility of the ED-RDDT to     reduce rehospitalizations in Medicare recipients visiting an urban Emergency Department for     non-traumatic illness      Hypotheses:        -  Compared to the standard screening tool, the ED RDDT will reduce reutilization of the          hospital (ED visits, hospital admissions, or death) within 60 days of discharge.        -  The ED RDDT will reduce costs to Medicare, hospitals and patients.   "
142684|NCT01416844|"     In this study, anti-OX40 will be given to patients with melanoma to find out how the immune     system responds to treatment with anti-OX40. It is hoped that this treatment will cause an     immune response against melanoma resulting in tumor regression, but this is not known at this     time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses     and cancer cells.   "
142685|NCT01416831|"     The purpose of this study is compare the response rates in patients with metastatic melanoma     treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation     therapy.   "
142686|NCT01416818|"     The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-Xiaoyao     Pill (Herb extracts)on depression, compared to placebo and Bupleurum+Ginkgo in patients     with Parkinson's disease.   "
142687|NCT01416805|"     This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)     program for children with anxiety disorders in community health centers. The first phase of     the study will offer insight into the feasibility of providing this intervention in community     health centers, while the second phase will compare CCBT to treatment as usual.   "
142688|NCT01416792|"     Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB)     apparatus which takes over the function of the heart and lungs while the surgeon performs the     necessary surgery. The residual blood left in the CPB equipment (1.5-2.0 L) is centrifuged     and washed leaving only red blood cells (RBCs) suspended in a saline solution. The RBCs are     reinfused into the patient as needed by the anesthesiologist. The main problem with this     technique is that many of the important components of the blood such as plasma proteins and     clotting factors are discarded through cell washing. This study will explore a novel method     (multiple-pass hemofiltration) of processing the residual pump blood which will allow the     patient to receive their own whole blood with minimum waste of important components. The     newer method of processing the residual pump volume has also been termed off-line modified     ultrafiltration (off-line MUF) and is similar to the process that the kidneys use to filter     the blood. It is hypothesized that multiple-pass hemofiltration of the residual CPB volume     will reduce the occurrence of inflammatory responses, preserve plasma proteins, and decrease     allogenic blood exposure and improve clinical outcomes as compared to centrifugation.   "
142689|NCT01416779|"     The overall purpose of this study is to develop and pilot-test a theory-based psychosocial     supportive finding balance intervention for older, bereaved spousal caregivers of a     palliative cancer patient.   "
142700|NCT01416636|"     The primary purpose of this study it to determine the effect on 6 minute walking test (MWT)     distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients with     Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.   "
142690|NCT01416766|"     This project will develop and test a low-cost approach to using health information technology     and home monitoring aimed at improving care for chronic conditions, with low barriers to     adoption in a wide variety of settings - from large group practices using state-of-the-art     electronic health records to small practices with no more than a computer with internet     access. Success will lead to a cost-effective approach to improving control of hypertension,     both among individuals with diabetes and among non-diabetics, which can make a substantial     contribution to the health of the population of the United States as improving hypertension     control is estimated to have a greater population health benefit than most other health     interventions. Success will also set the stage for adaptation of this intervention to a     variety of other chronic health conditions and further substantial improvements in the health     of millions of Americans.   "
142691|NCT01416753|"     Background: Data generated with the body composition monitor (BCM, Fresenius) show based on     bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated     with poor survival. However, removing excess fluid by lowering dry weight can be accompanied     by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that,     in comparison to conventional hemodialysis, blood-volume monitored regulation of     ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and     temperature (UTR) will decrease complications when ultrafiltration volumes are systematically     increased in fluid overloaded hemodialysis patients.      Methods/Design: BCM-measurements yield results on fluid overload (in liters), relative to     extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel group,     cross-over, randomized, controlled clinical trial, we use BCM-measurements, routinely     introduced in our 3 maintenance hemodialysis centers shortly prior to the start of the study,     to recruit 60 hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are     randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, 'final'     dry weight is set as -7% ECW postdialysis, and reached by reducing the previous dry weight,     in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase).     In case of intradialytic complications, dry weight reduction is decreased, according to a     pre-specified algorithm. A comparison of intra- and postdialytic complications among study     groups constitutes the primary endpoint. In addition, we will assess relative weight     reduction, changes in residual renal function, quality of life measures, and predialysis     levels of various laboratory parameters including C-reactive protein, troponin T, and     N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary     outcome parameters).      Discussion: Patients are not requested to revert to their initial degree of fluid overload     after each study phase, Therefore, the cross-over design of the present study merely serves     the purpose of secondary end-point evaluation, for example to determine patient choice of     treatment modality. Previous studies on blood volume monitoring have yielded inconsistent     results. Since we include only patients with BCM-determined fluid overload, we expect a     benefit for all study participants, due to strict fluid management which decreases the     mortality risk of hemodialysis patients.   "
142692|NCT01416740|"     This study will prospectively compare the findings of two diagnostic tests, Direct Magnetic     Resonance Arthrography(MRA) and Indirect MRA, to the findings during shoulder arthroscopy in     patients with shoulder pain. The sensitivity and specificity of both Direct and Indirect     MRA's in diagnosing specific pathologies of the shoulder will be determined using shoulder     arthroscopy as the gold standard.   "
142693|NCT01416727|"     The purpose of this study is to evaluate and compare the effectiveness of two forms of     clinical skills training for teaching emergency psychiatry skills to doctors who have just     started to work in psychiatry   "
142694|NCT01416714|"     The purpose of this study is to collect and store normal and malignant tissue from patients     with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary     cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an     estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with     gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary     cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create     a database for the collected tissue and allow access to relevant clinical information for     current and future protocols. To create tissue microarrays for each gastrointestinal cancer     subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular     cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal     cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia,     and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue     samples (normal and malignant) and relevant clinical information for the investigation of     tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs,     paxillin, focal adhesion proteins, cell motility/migration proteins,     tyrosine/serine/threonine kinase family members, related molecules, and downstream targets     implicated in the pathogenesis of GI cancers. Examples of molecular testing include     evaluation of DNA mutation, alternative splice variants, protein expression and     phosphorylation, and immunohistochemistry on samples. These studies will be correlated with     clinical information as stated above.   "
142695|NCT01416701|"     The purpose of this study is to examine the effect of vitamin D intervention in patients with     chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.   "
142696|NCT01416688|"     RATIONALE: Questionnaires that patients can use to assess skin toxicities related to     treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab,     or erlotinib hydrochloride.      PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in     patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib     hydrochloride.   "
142697|NCT01416675|"     Objective: Studies documenting the prevalence of delirium among critically ill children are     still rare. Emerging literature from psychiatric specialists reports the prevalence of     delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely     to be an underestimation of the true prevalence, as demonstrated in early adult delirium     literature, especially given the absence of validated bedside tools to diagnose delirium in     the PICU.      The primary aim of this study is to validate the German version of the Pediatric Confusion     Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is     to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence     Delirium (PAED) Scale.   "
142698|NCT01416662|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how patients will respond to treatment.      PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with     pancreatic cancer that has been removed by surgery.   "
142699|NCT01416649|"     This study investigates the effect of exenatide, a FDA approved medication for the treatment     of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be     studied before and during treatment with Exenatide.      Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient     visits over the course of 3-4 months.   "
142702|NCT01416610|"     This prospective, multi-center, observational study will evaluate the efficacy and safety of     Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously     untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance     therapy. Data will be collected from eligible participants receiving Pegasys and Copegus     treatment as prescribed by treating physician and treatment-free follow-up period of 24     weeks.   "
142703|NCT01416597|"     The purpose of this study is to consolidate the cross-protection offered by influenza     vaccines against circulating influenza A or B viruses that are not antigenically well-matched     to vaccine strains and to determine the degree of cross-protection separately for influenza A     and influenza B, through a systematic review of the literature.   "
142704|NCT01416584|"     The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in     promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment     injection heroine users.   "
142705|NCT01416571|"     This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A,     prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when     administered up to 5 years following production.   "
142706|NCT01416558|"     Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less     toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after     failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes     as part of their (neo-)adjuvant therapy. There is currently no standard treatment for     patients with an early relapse (<12 months) after a taxane containing (neo-)adjuvant therapy.     Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only     limited cross-resistant to solvent-based taxanes and might therefore be indicated in this     setting.   "
142707|NCT01416545|"     This study aims to evaluate if a multidisciplinary educational program in primary     cardiovascular prevention for children could improve the Framingham Score index of their     parents after one year.   "
142708|NCT01416532|"     To evaluate the prognostic value of coronary CT angiography (CCTA) for risk stratification in     asymptomatic adults in comparison with conventional risk stratification (CRS) and coronary     artery calcium scoring (CACS).   "
142709|NCT01416519|"     The objective of this study is to assess whether there is a difference between a care     protocol with the use of incentive spirometry (Voldyne ®) and another with the application of     NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main     focus of the study is to determine the incidence of pulmonary complications in each     technique.   "
142710|NCT01416506|"     Prospective, non-interventional, multi-center study. 7 investigative centers will involved in     China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae     isolates collected.   "
142713|NCT01416467|"     The late infantile form of galactosialidosis is potentially amenable to treatment by gene     transfer with an adeno-associated viral vector encoding Protective Protein Cathepsin A (PPCA)     or by infusion of purified protein. The published literature contains limited descriptions of     the disease nor is it known how many patients with the disorder are potentially available for     protocol enrollment. This preliminary study is designed to define the demographics and     clinical characteristics of the patient population with galactosialidosis. Individuals for     whom DNA diagnosis has been performed at St. Jude Children's Research Hospital (SJCRH) will     be contacted telephonically to learn their current status. In addition, a letter requesting     information regarding patients with galactosialidosis will be sent to all pediatric     geneticists throughout the United States. Selected physicians with expertise in lysosomal     storage diseases throughout the world will also be contacted. Foundations and Associations     for the lysosomal storage disorders will also be contacted in an effort to identify     additional potential patients with galactosialidosis. The information to be collected in this     preliminary study will facilitate development of specific eligibility criteria for future     therapeutic studies.   "
142714|NCT01416454|"     The purpose of the study is to assess potential age-related differences on coagulation     profile of patients undergoing Cesarean Section, using thromboelastography (TEG). The     investigators will compare coagulation data collected from the study to assess potential     differences in coagulation parameters for the following age groups: (i) women less than 35     yrs (ii) women 35 yrs or older.   "
142715|NCT01416441|"     The goal of the current trial is to obtain long term efficacy, safety and tolerability data     of Once weekly aripiprazole in children and adolescents with Tourette's Disorder.   "
142716|NCT01416428|"     The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and     safety of oprozomib in patients with hematologic malignancies.   "
142717|NCT01416415|"     The purpose of this study is to assess whether an educational intervention will have a     positive effect on patients' ability to properly administer eye drops. The investigators     predict that the educational intervention will have a positive impact on the efficacy,     safety, and efficiency with which patients administer their eye drops.   "
142718|NCT01416402|"     The purpose of this study is to determine whether arhalofenate is safe and effective when     dosed in combination with febuxostat in lowering serum uric acid in patients with gout.   "
142719|NCT01416389|"     The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to     ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change     in tumor size as a continuous measure of response.   "
142720|NCT01416376|"     SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic     inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The     objective of this study is to determine the effect of a single administration of SRT2379, at     multiple-dose levels, on the inflammatory response to low dose endotoxin.   "
142740|NCT01416116|"     The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is     applied prior to the application of QUTENZA. This is a multi-center, randomized,     assessor-blinded study which will investigate the use of an oral analgesic as an alternative     form of pre-treatment for QUTENZA.   "
142721|NCT01416363|"     This study will investigate how 3 types of drug formulations are absorbed by the body. This     study is termed 'open-label', which means volunteers will be aware of which treatment they     are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new     formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in     this study. Volunteers will also receive a single dose of a formulation used in previous     trials (reference formulation), so a proper comparison with the new formulations can be made.     The new fomulations will be administered with food and the reference formulation will be     given without food. In Part 2, volunteers will receive only one of the 3 formulations as a     repeat dose for 7 days. Each of these doses will be given with food.   "
142722|NCT01416350|"     This is a two part protocol (Parts A and B) in healthy volunteers evaluating the     pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of     various biomarkers (e.g., Interleukin-10 (IL-10), Granulocyte macrophage colony-stimulating     factor (GM-CSF), mature dendritic cell (MDC), with and without ex vivo lipopolysaccharide     (LPS) stimulation) as markers of macrolide anti-inflammatory activity.      Part A is a randomized, open-label parallel group study evaluating PK/PD of a single     azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose     resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of     azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory     conditions). This information will guide the range of doses to be studied in a first time in     humans (FTIH) study of a new chemical entity.      Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for     3 weeks), the dose approximates that used in the treatment of chronic neutrophil related     inflammatory conditions. This information will provide insight into whether the biomarker     effects change over time on repeat dosing and any potential differences observed between     single and repeat doses.   "
142723|NCT01416337|"     A Phase I, single-center, open-label, single-persiod, combined single dose oral and IV     microtracer study in subjects with solid tumors.   "
142724|NCT01416324|"     The purpose of this study is to look at the safety and tolerability of increasing single     doses of GSK2330672 in healthy volunteers.   "
142725|NCT01416311|"     To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects     receiving the drug until data from a specified number of subjects are accumulated to identify     factors considered to influence its safety and efficacy.      <Priority investigation item> Thromboembolism   "
142732|NCT01416220|"     This study is being done to look at how well people respond to two different drug treatments     for depression. Clinically, people can respond differently to different treatments for     reasons which are not always clear. Some research shows that people with a family history of     bipolar disorder or completed suicide may react differently to standard medications used to     treat depression than those without a family history. The investigators need to know if these     drugs are effective to use in patients with depression who have a family history of bipolar     disorder or completed suicide.   "
142726|NCT01416298|"     Acute Kidney Injury (AKI) is a common clinical problem defined by an abrupt (< 48 hour)     increase in serum creatinine (SCr) resulting from an injury or insult that causes a     functional or structural change in the kidney. Despite significant advancements in the care     of the critically ill child, mortality rates observed in critically ill children who develop     AKI have not improved. The investigators have shown even small increases in SCr, which is     the standard kidney function marker, are associated with increased child mortality, even when     outcome was controlled for significant patient co-morbidity. Furthermore, the investigators     have also shown that the amount of fluid accumulation observed in critically ill children     with AKI is independently associated with mortality suggesting that earlier dialysis may     improve survival. However, the investigators also do not want to dialyze patients who don't     ultimately need dialysis, as it is an invasive procedure. The data cited above highlight the     need not only to detect AKI early, but also predict it severity in order to optimize clinical     decision making with respect to fluid administration and dialysis initiation. While     substantial research has been expended to validate NGAL as an early marker of AKI, it has not     been studied in the context of clinical decision support to guide a therapeutic intervention.     The investigators hypothesize that NGAL levels can be used to determine predict which     critically ill children will develop severe and prolonged AKI with substantial volume     overload, thereby providing the clinician with a diagnostic tool to guide CRRT initiation.   "
142727|NCT01416285|"     Congestive heart failure (CHF) is a major public health problem worldwide. CHF carries a     devastating prognosis, which resembles that of some types of malignant cancer. Despite     substantial improvements in the management of the disease, the prognosis remains poor     especially in advanced stages of the disease. For these patients, self-management plan     includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and     knowing what to do if signs of deterioration appear, and when to report the changes to     health. The investigators hypothesize that patients in the heart failure management programs     that promote self-management by means of intensive education, edema index-assistance, and     telephone follow-up can improve their functional status and quality of life, as well as the     biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.   "
142728|NCT01416272|"     The objective of this twelve month dispensing study is to evaluate the clinical performance,     particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.   "
142729|NCT01416259|"     This Phase I study will be performed in a double-blind, randomized, crossover design in     healthy male and female subjects. The central ECG laboratory will be blinded to treatment.     Every effort will be made to enroll equal numbers of males and females into the study.      Eligible subjects will participate in a screening phase (within 28 days of the dosing day), a     treatment phase and a final visit, which will be conducted on discharge from the study. Study     duration will be 32 days with a total of approximately 12 days of confinement. During the     resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at     selected time points to assess potential ECG effects. Blood samples for PK evaluation will be     collected in conjunction with the ECG time points.   "
142741|NCT01416103|"     The purpose of the study is to determine whether welfare-to-work schemes combined with     alcohol treatment are more efficient than a welfare-to-work scheme alone, for unemployed     citizens with alcohol problems.   "
142800|NCT01415336|"     Capecitabine has shown high efficacy in metastatic and adjuvant settings. This is a     prospective, randomised trial, to compare the efficacy and safety profiles of     capecitabine-containing regimen with non- capecitabine-containing adjuvant chemotherapy     regimens for node negative breast cancer patients.   "
143398|NCT01407419|"     The Treat to Target Trial is a clinical trial available to new and existing CORRONA (Data     Collection Program) sites. Subjects are recruited to participate in this 12 month trial     examining outcomes and feasibility of implementing a Treat to Target approach, when compared     with a control group of subjects treated with usual care.   "
142730|NCT01416246|"     Multiple myeloma is difficult to treat with only anti-cancer medicine (called chemotherapy)     or radiation alone. Sometimes higher doses of chemotherapy are used but when used can also     lower blood counts. Using own cells (special cells called stem cells) to help increase the     blood counts after high doses of chemotherapy is called autologous stem cell transplantation     (ASCT).      Using own stem cells to restore blood counts and other advances in supportive measures     (antibiotics and growth factors that increase blood counts) has improved the safety of ASCT.     However, blood counts still decrease for a period of days after high doses of chemotherapy.     During that time, patients are at greater risk for infections. Studies have shown that the     faster the blood counts recover after ASCT, the less at risk there is for developing unwanted     side effects after ASCT.      Typically during an ASCT, a patient's stem cells are given back to them all at once on a     single day. In this study, the investigators plan to see what happens when smaller amounts of     own stem cells are given back to the patient over multiple days. The investigators want to     find out what effects good and/or bad this will have on the patient and there multiple     myeloma. Some studies have shown that giving back stem cells over a period of days helps to     increase bone marrow activity and decrease the time it takes for blood counts to recover     after ASCT. It is our hope that this new approach may lower a patient's risk of side effects     and infections, decrease the number of blood transfusions that a patient needs during this     process, reduce the time a patient has to spend in the hospital, and lower overall treatment     costs.   "
142731|NCT01416233|"     After enucleation or evisceration with placement of a dermis fat graft or integrated orbital     implant as a primary procedure, there can be secondary loss of orbital fat volume causing     regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques     for correction require open surgery to place a sheet/block of biocompatible material or a     macroaggregate of fat into the orbit to augment orbital volume for permanent correction.     Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but     these have proved to be temporary. The current study seeks to show that a permanent     augmentation of orbital volume can be achieved using a closed cannula injection of autologous     fat.   "
142758|NCT01415882|"     This randomized phase II trial studies how well ixazomib (ixazomib citrate) works in treating     patients with multiple myeloma that has returned after a period of improvement but is not     resistant to bortezomib. Ixazomib citrate may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth.   "
142735|NCT01416181|"     This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of     the placebo-controlled period (Part 1), participants will have the option of enrolling in a     2-year open-label extension (Part 2).      Part 1: The primary objective of the study is to investigate whether treatment with     natalizumab slows the accumulation of disability not related to relapses in participants with     secondary progressive multiple sclerosis (SPMS).      The secondary objectives of Part 1 of this study are to determine the proportion of     participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in     participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12),     the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab     on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical     (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24     using magnetic resonance imaging (MRI) and the proportion of participants experiencing     progression of disability as measured by individual physical Expanded Disability Status Scale     (EDSS) system scores.      Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of     natalizumab in participants with SPMS.      The secondary objectives of Part 2 of the study are to investigate long-term disability     (based on clinical or participant-reported assessments) in participants with SPMS receiving     natalizumab treatment for approximately 4 years and to assess change in brain volume and T2     lesion volume.   "
142736|NCT01416168|"     Surgery for colorectal cancer is a major surgery. People above the age of 60 tend to have a     higher risk of complications. Some studies indicate that senior cancer patients might benefit     from a home support after surgery by a geriatric nurse practitioner and a team, beside their     usual post-operative care. The investigators team is planning a large study to assess whether     this approach could help patients with colorectal cancer recover better from their surgery,     get better cancer treatment after that (e.g. chemotherapy), and possibly live longer. This     study you are asked to take part in is a pilot for this large study.   "
142737|NCT01416155|"     The primary objective of the study is to further evaluate the long-term safety and     tolerability profiles of BG00002 (natalizumab) in Japanese participants with     relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to     further evaluate the long-term efficacy profile of BG00002 in Japanese participants with     RRMS.   "
142738|NCT01416142|"     The objective of this study is to evaluate the product performance of PureVision2 HD contact     lenses.   "
142739|NCT01416129|"     The investigators are comparing a new type of prosthetic socket for above knee amputees to     the standard of care. The hypothesis is that the new type of socket will show equivalence to     the standard of care using our designated outcome measures.   "
142742|NCT01416090|"     Syndactyly is a relatively common congenital abnormality of the hand occurring approximately     1 out of 2500 live births (1). It can be simple, meaning only skin and soft tissues are     shared, or complex, meaning the bone or nail parts are shared. In any case, it is a fact that     there is not enough skin surrounding the two finger segment to be utilized to cover two     separate fingers. This can also be proven by simple geometry. Therefore, it has always been     taught to residents and explained to numerous patients' families that addition of skin graft     is required for a proper syndactyly release. Without it, skin flaps would be too tight,     causing some necrosis and significant scarring along the finger and particularly in the web     space, causing an unsatisfactory functional and cosmetic result requiring revision.   "
142743|NCT01416077|"     Surgery for cancer of the esophagus is associated with a high risk of postoperative     complications. It has been shown that the risk of postoperative complications can be     decreased by optimising the amount and type of infusion fluids given during surgery, steered     by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler.     This device can however not be used during this type of surgery. This study wants to test the     hypothesis that postoperative complications in patients operated for esophageal cancer can be     partially prevented by using a goal directed strategy for the administration of fluids and     drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave     analysis (FloTrac).   "
142744|NCT01416064|"     Open-label, extension study for subjects that completed 810P202 to examine long term safety     and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with     Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).   "
142745|NCT01416051|"     Today's obesogenic environment, favors behavioral choices that lead to an excess of energy     intake over expenditure, and consequently weight gain. Intervention strategies that harness     the body's own appetite and satiety regulating signals could provide an effective means of     countering excessive energy intake. The purpose of this study was to investigate whether a     vegetable oil emulsion (Olibra) would result in weight loss that was associated with a     reduction in food intake.   "
142746|NCT01416038|"     Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to     destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2,     and even phase 3 trials. Much has been learned about the principles of applying immune-based     therapies and specifically the types of patients that may be most likely to mount an     effective immune response. When used alone, cancer vaccines may have their greatest impact     earlier in the disease course or in situations with minimal residual disease.      ImmunoVaccine Technologies Inc. (Immunovaccine) is an immuno-oncology company developing a     novel adjuvanting technology platform termed DepoVax. DepoVax was created to enhance the     speed, strength and duration of an immune response. The peptide antigens included in     DPX-Survivac are designed to target Survivin, a protein which is over-expressed in many     cancer types, including epithelial ovarian cancers.      This study was designed be a phase 1-2 trial to determine the safety and immunogenicity     profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose     oral cyclophosphamide. The dosing-finding phase 1 study of 15 subjects would move directly     into a randomized phase 2 study. However, with the evolving field of immunotherapy     Immunovaccine has begun to focus on combination therapies, combining DPX-Survivac treatment     with checkpoint inhibitors and other immune modulators, such as in NCT02785250.   "
142747|NCT01416025|"     This is a prospective, multicenter, randomized trial to study therapeutic drug monitoring     (TDM) of voriconazole among patients with an invasive mould infection (IMI). The primary     objective of this study will be to assess the effect of prospective voriconazole TDM on the     composite of adverse events (AE) and clinical response.   "
142748|NCT01416012|"     Interactive games (virtual reality) have recently been the center of interest and scientific     discussion in the field of cognitive and functional rehabilitation. From their entertaining     and contextual aspects, off-the-shelf video games are potentially interesting tools as     adjunct to the patient care, especially for maintaining instrumental activities of daily     living (IADL) autonomy.      Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing     health related quality of life (HRQL). This decrease in cognitive and functional abilities     can be slowed down using adapted rehabilitation program.      However, there is no randomized controlled study comparing usual physical therapy to virtual     reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect.      Off-the-shelf gaming consoles offer a large range of games where cognitive and functional     abilities from geriatric patients could be stimulated and consequently HRQL improved.      However, a better knowledge of the potential cognitive and functional improvement processes     from virtual reality rehabilitation in institutional routine is needed to enhance the quality     and the range of the available care in old adults.      This study will not only be a validation platform of virtual reality as stand alone     rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming     consoles in HRQL improvement of old adults.      The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL     changes of patients with Alzheimer disease and related disorders.      •Method      This study is a randomized controlled trial that comprises two study phases :      Phase one; comparing three parallel groups where therapists and assessors will be kept blind     of study objectives, and Phase two, the investigators will take the most cost-effective     gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will     use it as an adjunct to physical therapy compared to physical therapy alone, with respect to     the same amount of rehabilitation time.      The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after     intervention.      Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or     physical therapy as the 'gold' standard condition.      All groups will receive the same amount of rehabilitation time. Power and sample calculation     for phase two will be based on phase one results.   "
142749|NCT01415999|"     Anthracyclines have been used commonly to treat children with solid tumours and     haematological malignancies and have led to their increased survival. Nonetheless,     anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess     the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel     interaction, usefulness of circulating biomarkers in the assessment of heart function and     potential genetic predisposition to heart failure in adult survivors of childhood cancers.   "
142762|NCT01415830|"     The morbidity associated with scorpion sting intoxication presents an endemic pattern in the     country, where there are highly venomous species of scorpions so the scorpion sting     intoxication (IPPA) is considered a medical emergency.      On the other hand, there is scarce scientific literature from different controlled studies     evaluating anti-scorpion serum, considering clinical severity scales, lab results and their     safety. The aim of this study is to compare the efficacy and safety of scorpion sting     treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).   "
142763|NCT01415817|"     Effective colorectal cancer (CRC) screening relies on early identification and removal of     both polypoid and non-polypoid lesions with neoplastic potential. The investigators     hypothesize that an intensive training program designed to enhance both recognition and     classification of lesions with neoplastic potential, will result in an increase in     non-polypoid adenoma detection in addition to and independent of an increase in overall     adenoma detection rates.   "
142750|NCT01415986|"     Presently, there is no effective treatment for patients with advanced head and neck cancer     (AHNC) that failed to respond to the standard therapy (radiation, chemotherapy and surgery)     in the US. These patients are deemed incurable AHNC. In the European Union (EU), interstitial     photodynamic therapy (I-PDT) with Temoporfin is approved for the treatment of patients with     incurable AHNC. Well designed EU studies have shown that I-PDT with Temoporfin can provide     worthwhile palliation by reducing tumor size, bleeding and pain in 53% - 60% of patients with     incurable AHNC. This is a significantly higher rate in comparison to the reported response     rate of palliative chemotherapy (6-30%). However, the EU studies did not correlate     quantitative tumor response with clinical outcome. In addition, quality of life (QoL)     improvements associated with I-PDT of AHNC using Temoporfin were also not evaluated.      The objective of this study is to quantify the tumor response and patient's QoL to I-PDT with     Temoporfin. Successfully meeting this objective will give us the tools the investigators need     to design larger studies to significantly improve the management and QoL of patients with     AHNC.   "
142751|NCT01415973|"     This study will compare the effects of cooked, ground beef to those of beef protein isolate     on blood and muscle proteins.   "
142752|NCT01415960|"     Some patients with prostate cancer benefit from androgen deprivation therapy which reduces     levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone     (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL.     Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is     released slowly over time and effectively reduces testosterone levels in many patients to     ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be     administered by intramuscular injection twice over a period of 6 months. The proportion of     patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.   "
142753|NCT01415947|"     The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system,     consists in the ability to adjust (elongate or shorten) the neochordae off-pump to achieve     an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal     replacement by enabling accurate sizing of the chords.   "
142754|NCT01415934|"     The purpose of this study is to determine if there is a difference in survival rate at 60     days after enrollment between patients with advanced life-limiting illness for whom statins     are discontinued vs. for patients with advanced life-limiting illness who are maintained on     the medication. Secondary outcomes of this study will determine the effects of medication     cessation on overall survival, important cardiovascular events, quality of life (QOL),     symptoms, performance status, polypharmacy issues, satisfaction with care, and costs.   "
142755|NCT01415921|"     Heart failure, a common heart disease affecting nearly 6 million Americans, is associated     with high rates of hospitalization and death. Abnormalities in the autonomic nervous system     are thought to play an important role in the progression of heart failure. This proposal aims     to determine whether novel application of pyridostigmine, a drug currently approved by the     FDA only for the treatment of neuromuscular disease, can improve autonomic nervous system     function in heart failure patients.   "
142756|NCT01415908|"     This investigation will provide safety and effectiveness information on the use of INFUSE®     Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a     Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels     from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.   "
142757|NCT01415895|"     ATNC05 is a combination of two known marketed generic compounds. The investigators     hypothesize that the combination acts synergistically to reduce chronic radicular neuropathic     back pain of the cervical, thoracic and the lumbar regions.   "
142759|NCT01415869|"     The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD)     patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood     test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of     gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over     time by estimating the proportion of VAD patients with a positive test prior to implantation;     at one week, one month, three months, six months and one year post implantation, and after     explantation of the VAD and to evaluate whether presence of any abnormal fecal HemoQuant test     is predictive of a future major bleeding event.   "
142760|NCT01415856|"     The purpose of this study is to determine whether the Torino II device, which emits a pulsed     electromagnetic field), will help to decrease pain and swelling after knee replacement     surgery, and thereby decrease the use of narcotic medications after surgery.   "
142761|NCT01415843|"     Associated reactions are unintended and involuntary arm movements, normally seen as bending     of the wrist and elbow, that may occur after stroke when a person is doing something     effortful such as walking.      This is the first phase of a study that will investigate the effects that different     approaches to physiotherapy have on the expression of associated reactions. During this     phase, current practice among neuro-physiotherapists will be explored in relation to: the     learning strategies used in stroke rehabilitation, the common interventions used in gait     re-education, and the strategies adopted for the assessment and management of associated     reactions.      The objectives are:        -  To provide an insight into the learning strategies used by physiotherapists during the          re-education of walking, including the verbal dialogue that takes place and any          preferences (overt or subconscious) adopted for one type of learning strategy.        -  To develop and refine a description of what is meant by the term gait re-education        -  To provide an insight into how therapists currently manage associated reactions      This phase of the study will explore these objectives using direct non-participation     observation of a number of physiotherapy treatment sessions. This will provide an insight     into the nature of the therapy that takes place for retraining walking(e.g. the types of     exercises commonly used) and the nature of the learning strategies frequently adopted,     including the amount and content of explicit verbal instruction and feedback that is provided     to patients.   "
142767|NCT01415765|"     Background:      - MLN4924 is an experimental cancer drug. It may help kill lymphoma cells and make them more     sensitive to chemotherapy. EPOCH R is a combination chemotherapy drug. It has been effective     in treating some cases of large B-cell lymphoma. This research will look at two things. The     first is the effect of MLN4924 on its own in treating large B-cell lymphoma. The second is     the safe dose and effect of MLN4924 and EPOCH-R in combination when treating large B-cell     lymphoma.      Objectives:        -  To study how MLN4924 affects large B-cell lymphoma tumors.        -  To compare the effects of MLN 4924 alone and MLN4924 plus standard EPOCH-R chemotherapy.      Eligibility:      - Individuals at least 18 years of age who have large B-cell lymphoma that will be treated     with chemotherapy.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood and urine tests, tumor samples, and imaging studies.        -  Participants will receive MLN4924 for a maximum of six 21-day cycles of treatment. Each          cycle involves a dose of MLN4924 twice a week for 2 weeks, followed by a 1-week rest          period. Participants will be monitored with frequent blood tests and imaging studies.        -  Participants who do not benefit from MLN4924 alone will have MLN4924 along with EPOCH-R          chemotherapy for up to six cycles of treatment.   "
142768|NCT01415752|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.     Others interfere with the ability of cancer cells to grow and spread. Drugs used in     chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer     cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking     some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell     lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab     together with bendamustine and bortezomib is more effective than rituximab and bendamustine,     followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.      PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and     lenalidomide in treating previously untreated older patients with mantle cell lymphoma.   "
142769|NCT01415739|"     This research studies protein in tumor samples from patients with non-small cell lung cancer.     Finding specific proteins in tumor tissue samples from patients with cancer may help doctors     tell what type of lung cancer a patient has and plan better treatment.   "
142770|NCT01415726|"     Type 2 diabetes is the most common form of diabetes. The prevalence of diabetes has been     markedly increased in recent years. More and more children and young adults develop this     devastating disease. Despite of multiple factors (e.g., food, environmental, and genetic     factors) contributing to the developing of diabetes, increasing evidence demonstrated that     chronic inflammation and/or atuoimmunity are common issues and play key roles in the     pathogenesis of type 2 diabetes, leading to the insulin resistance and the shortage of     insulin-producing islet beta cells. Thus, anti-inflammation is becoming a novel approach for     the treatment of type 2 diabetes. Evidence that multipotent stem cells derived from human     cord blood (CB-SCs) can control inflammation and autoimmune responses by altering regulatory     T cells (Tregs) and human islet beta cell-specific T cell clone in type 1 diabetes offers     promise for a new approach to treat type 2 diabetes. Here, the investigators develop a novel     Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Stem     Cell Educator therapy in T2D patients.   "
142771|NCT01415713|"     Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen     Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary     objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease     control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor     progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study   "
142783|NCT01415557|"     The purpose of this study is to assess the impact of regular consumption of micronutrient     fortified drink in improving nutritional and micronutrient status in Indian school children.     The test beverage will be fortified with both, vitamins and minerals.   "
142772|NCT01415700|"     The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after     central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve     the patient's walking floor by removing the STEPPAGE, reducing the effort of walking,     facilitating the flow and removing anomalies compensatory (such as the mowing of the hip).     Its objective is to improve the patient's autonomy locomotor.      The aim of this study is to compare the results of the implementation of an implanted     stimulator in the levator muscles of the foot to the results obtained by wearing a     splint-type reliever, which is considered standard treatment, in order to determine if the     implanted stimulation may be proposed in the treatment of foot drop off a neurological     center.   "
142773|NCT01415687|"     The objective of this study is to compare the efficacy, safety and tolerability of two bowel     preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax     plus Bisacodyl - with a specific emphasis on the right colon cleanliness.      The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of     preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes     will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.   "
142774|NCT01415674|"     The purpose of this study is to identify predictive and pharmacodynamic biomarkers of     activity and efficacy of pre-operative Afatinib (BIBW2992) in untreated non-metastatic head     and neck squamous cell carcinoma patients   "
142775|NCT01415661|"     This investigation was designed to assess the patency of the esophageal entrance during     cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the     Glidescope ® video laryngoscope (GVL).   "
142776|NCT01415648|"     In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an     ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no     consensus concerning the best cerebral monitoring and hemodynamic optimisation during carotid     cross-clamping.      The objective of this prospective, multicentric, double-blinded and randomized study is to     evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter     to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset     of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness analysis will be     conducted to estimate the impact of this monitoring versus standard care on direct and     indirect postoperative costs during 120 days.      A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a     serum marker of brain injury, protein S-100B   "
142777|NCT01415635|"     Background:      The investigators have previously documented that patients at nutritional risk lack     sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized     historically controlled intervention study of 40 patients at nutritional risk. The study     indicated that a tailored food concept increased nutritional intake in this patient group.      The objective of the current study is therefore to investigate these findings in a randomized     clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of     their energy and protein requirements.      Methods:      The study will compare standard nutritional care (control group) with tailored nutritional     care (the possibility to order small energy and protein-enriched dishes called Delights of     Herlev Hospital). 96 patients at nutritional risk, according to the NRS-2002 criteria, will     be included in the study.   "
142778|NCT01415622|"     The purpose of this study is to prove the safety and efficacy of plasma as an add-on     treatment in combination with conventional treatment in cases of chronical venous Ulcus     cruris.   "
142779|NCT01415609|"     The purpose of this study is to monitor the success rates and completion rates for endoscopic     submucosal dissection (ESD) for gastrointestinal (GI) cancers.   "
142780|NCT01415596|"     Many athletes use beta2-agonists as treatment of airway hyperresponsiveness during exercise.     High dose beta2-agonists may have an ergogenic effect on exercise performance. We hypotheis     that the beta2-agonist, salbutamol, taken in high doses can improve muscle power and recovery     during exercise in well-trained athletes.   "
142781|NCT01415583|"     Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after     tonsillectomy is one of the risks of this surgery and can be more dangerous in children since     they have less blood volume than adults. In order to improve recovery after tonsillectomy,     steroids (medication that is a strong anti-inflammatory) are often given during the surgery.     Recently, a study showed steroids given at the time of tonsillectomy increase the risk of     bleeding significantly over children who did not receive steroids. This finding has raised     concerns in the Ear, Nose, and Throat (ENT) community since most ENT's use steroids during     tonsillectomy in children. The investigators look to explore this question further.      To answer the question of whether perioperative steroid administration significantly affects     the rate of post-tonsillectomy bleeding, the investigators propose to test the following     hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does     not cause an increase in post-operative bleeding rate in tonsillectomy.   "
142782|NCT01415570|"     In the United States, African Americans are 3.6 time and Hispanics 1.5 times more likely to     suffer from chronic kidney disease and need dialysis treatment for life, when compared to the     non-Hispanic Whites. Unfortunately many dialysis patients die, so that after 5 years only     less than 35% are still alive. Dialysis patients who appear malnourished or who have muscle     and fat wasting are even more likely to die. Interestingly, among dialysis patients,     minorities (African Americans, Hispanics and Asian Americans) usually survive longer than the     non-Hispanic Whites. If the investigators can discover the reasons for these so-called     racial survival disparities of dialysis patients, the investigators may be able to improve     survival for all dialysis patients and maybe even for many other people who suffer from other     chronic diseases. During this 5 year study the investigators would like to test if a     different nutrition and diet can explain better survival of minority dialysis patients. The     investigators will also test if in additional to nutrition there are 2 other reasons for     better survival of minority dialysis patients, namely differences in bone and minerals and     differences in social and psychological and mental health. The investigators plan to study     450 hemodialysis patients every 6 months in several dialysis clinics in Los Angeles South Bay     area. These subjects will include 30% African Americans, 30% Hispanics, 30% non-Hispanic     Whites and 10% Asians. Every 6 months the investigators will examine their nutritional     conditions, dietary intake, psycho-social conditions and quality of life, and will recruit 75     new subjects to replace those who left our study as a result of kidney transplantation, death     or other reasons. Hence, the investigators estimate studying a total of 1,050 hemodialysis     patients over 5 years. Clinical events such as hospital admissions and survival will be     followed. Blood samples will be obtained every 6 months for measurements of hormones and     biomarkers, and the remainder of the blood will be stored in freezers for future     measurements. The investigators plan to design and develop race and ethnicity specific     nutritional risk scores and food questionnaires and will test some of these scores in larger     national databases of hemodialysis patients. Almost a year after the study starts, the     investigators also plan to do additional tests of body composition and dietary intake in a     smaller group of these patients at the GCRC.   "
142788|NCT01415492|"     This study (aka Healthy Directions2 or HD2) builds on an earlier study titled Healthy     Directions (aka Healthy Directions 1 or HD1). HD1 was an intervention designed to target     cancer prevention among multi-ethnic populations; it led to significant improvements in the     multiple risk behavior score (consumption of red meat, fruits and vegetables, and     multi-vitamins). Building on the success of HD1, HD2 further expanded the intervention to     include smoking and physical activity. In addition, it expanded the study goals to include     increasing efficacy across all target risk behaviors, and promoting long-term maintenance of     behavior change.   "
142801|NCT01415323|"     Agitation is associated with a number of acute psychiatric conditions, and frequent in acute     psychiatric admissions. It is associated with violence towards others, and strongly     associated with in-patient suicides.      The main aims of the study are to assess different clinical presentations of agitation at     admittance, and to assess the consequences of these different clinical presentations during     the first three days of the stay.   "
142886|NCT01414192|"     This study is being done to provide valid data on the evolution of a cohort of French     participants treated with ezetimibe, alone or in combination with a statin, to be used in     simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk     factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density     lipoprotein cholesterol (LDL-C) levels over time will be analyzed.   "
142789|NCT01415479|"     Fifty thousand people die from colorectal cancer (CRC) every year, making it the second     leading cause of death from cancer in the United States. And although there are multiple     screening tests that reduce the morbidity and mortality of this disease, less than 60% of     eligible individuals are up to date with recommended screening.      One of the challenges to improving screening is helping patients understand the range of     approved tests, including colonoscopy, sigmoidoscopy, and stool testing (such as fecal     immunochemical testing (FIT)). Patients rarely consider all their options, partly due to the     limited time they have to learn about them during busy doctor's visits.      Computer-based presentations, including decision aids, are a promising tool for improving     patient understanding in this and other areas, by giving patients significant amounts of     information.      But there are important questions about how to design such presentations, including whether     they should provide quantitative data about the risks and benefits of screening. Some experts     feel that these numbers and graphs are necessary for fully informed decision-making, while     others are concerned that they may confuse patients or dissuade them from screening.      The investigators have created and pilot tested a computer-based presentation of quantitative     information about CRC screening. The investigators found that subjects who viewed the program     in a non-healthcare setting exhibited significantly increased interest in screening. In     addition, the investigators tested a version of the program that includes a nudge towards     stool testing with FIT, as a way of encouraging individuals who are confused to undergo some     form of screening. In our testing, receiving the nudge was associated with a significant     increase in interest in FIT.      The investigators now seek to conduct a randomized, controlled study of our computer-based     presentation with Clarian patients who are due for CRC screening. All subjects will first     view a general video about CRC screening and then will be randomly placed into four groups     (using a 2x2 design), to receive quantitative information (or not), and a nudge towards FIT     (or not).      The results will determine whether a presentation of quantitative information can increase     patient understanding, quality of decision-making, and uptake of CRC screening. The results     will serve as pilot data for a larger, externally funded study of the effect of     individualized (personalized) quantitative information in this area   "
142790|NCT01415466|"     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug     interaction between rosuvastatin and CS-866 in healthy male volunteers.   "
142791|NCT01415453|"     Retinitis pigmentosa (RP) is the name given to a group of inherited eye diseases that affect     the retina (the light-sensitive part of the eye). RP causes the breakdown of photoreceptor     cells (cells in the retina that detect light). Photoreceptor cells capture and process light     helping us to see. As these cells breakdown and die, people experience progressive vision     loss. There is no known cure for retinitis pigmentosa. The investigators have observed that     short pulses of focused ultrasound can cause perception of light when directed to spots on     the retinal surface. The investigators propose to conduct a study to determine if pulsed     ultrasound will stimulate the perception of light in the absence of functional photoreceptors     in people with RP   "
142792|NCT01415440|"     The aim of this study is to examine the mechanisms by which stimulant medications reduce     symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic     Resonance Imaging (MRI), the investigators have found that the volumes of certain brain     regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if     patients had been treated with stimulant medications, suggesting that stimulants may reduce     the symptoms of ADHD by reversing these volume reductions. In a second and related study, the     investigators found that in patients with ADHD, emotional processing was normalized when     patients were taking stimulant medications. Both studies point to possible mechanisms by     which stimulants are effective; however, a significant limitation of these findings is that     they were derived from cross-sectional studies.      In this current study, the investigators hope to replicate these treatment effects of     stimulants in a prospective, controlled manner. The investigators plan to measure ADHD     symptom severity in patients before and after 12-weeks of controlled treatment with either a     stimulant medication or placebo while utilizing structural and functional MRI. Combining     imaging with a randomized controlled trial will allow us to better assess the effects of     stimulants on brain function and structure.   "
142793|NCT01415427|"     This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0     mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis     IVA (Morquio A Syndrome).   "
142794|NCT01415414|"     It is a prospective, non-interventional, multi-center study. The primary objective of this     study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced     CT considering the routine use in patient population's, region's indication.   "
142795|NCT01415401|"     The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®     from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients     with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).   "
142796|NCT01415388|"     The purpose of this study is to assess the effect of 12 weeks of daily supplementation with     Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects     whose habitual fatty fish and seafood intake is low and who have borderline high or high     fasting serum triglyceride levels.   "
142797|NCT01415375|"     This study evaluates the efficacy of a tailored telephone intervention to promote informed     decision making about prostate cancer testing among predominantly immigrant black men.   "
142869|NCT01414426|"     This randomized phase II trial studies how well vandetanib works in preventing head and neck     cancer in patients with precancerous head and neck lesions. Chemoprevention is the use of     certain drugs to keep cancer from forming. The use of vandetanib may keep cancer from forming     in patients with premalignant lesions   "
142798|NCT01415362|"     In this pilot study, the researchers investigated the feasibility of a closed-loop     electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for     treatment of epilepsy. They looked to see the feasibility of triggering tDCS stimulation     within 10 seconds of a detected EEG partial-onset seizure, and also a proof-of-principle     determination of whether tDCS applied during this vulnerable period may be feasible to     prevent the oncoming seizure.      This study required 5 visits over the course of approximately 8 weeks. Each visit was     separated by at least 2 weeks. Two of the visits had 24-hour EEG monitoring sessions. During     these two sessions, the EEG and tDCS were hooked into a closed loop system, such that when     seizure activity wasdetected, the tDCS was triggered to deliver stimulation. Subjects     received active stimulation or sham stimulation sessions during the first 24-hour visit, and     the opposite during the second. The subjects were randomized and counterbalanced.      We have also added a healthy subjects cohort to assess the feasibility of the closed loop     system. In order to test the proof-of-concept of this system, the experiment will focus on     detecting and acting upon alpha- and beta-band changes traced in the EEG activity that is     being recorded, and provide tDCS stimulation based upon those changes. We will enroll 6     subjects who will have 2 visits each. During these two visits subjects will be randomized to     active or sham stimulation sessions and receive the opposite during their second visit.   "
142799|NCT01415349|"     This is a drug interaction study evaluating whether blood plasma concentrations of     SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.   "
143409|NCT01407276|"     This is a 2-part study in participants with renal impairment and matched healthy participants     to investigate the effect of impaired renal function on the plasma and urine levels of     omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.   "
142802|NCT01415310|"     QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry.     The objectives of the register are to enhance our knowledge of old persons with severe     psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for     these patients. The data in the register will be used for quality assurance and for research.      Aims:        -  Quality assurance        -  Further development of our diagnostic and screening tools        -  Contributing to improving the treatment, with and without drugs        -  Contributing to improving the dialogue and collaboration between primary healthcare and          hospitals   "
142803|NCT01415297|"     The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339,     a ruthenium containing compound administered intravenously on a weekly schedule, in patients     with advanced solid tumors. The responses to treatment in this population will be evaluated.     In addition, the PD and PK properties of the compound will be explored.   "
142804|NCT01415284|"     The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4     which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women     undergoing a cesarean section under spinal anesthesia.   "
142805|NCT01415271|"     The incidence of type 2 diabetes in long term care facilities has been approximated at 25%     with barriers to treatment including untimely access to a specialist and improper/poor     adherence to insulin regimes. This 3 month trial will investigate the efficacy of improving     overall glycemic control by using an internet blood glucose reporting system to facilitate     bi-weekly consultations between long term care facility patients with type 2 diabetes and an     endocrinologist.   "
142806|NCT01415258|"     The objective of this study is to uncover the prevalence of vulnerability among patients aged     ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the     short screening test Vulnerable Elders Survey 13 (VES-13).      The objective is to better understand the value of routine screening of patients before the     consultation, it was proposed as a secondary objective of this study to assess the     correlation between the identification of the vulnerability in the screening test VES-13 and     the identification made by the clinician during the consultation. The correlation between     VES-13 and opinion of the clinician for three categories of patients (self - intermediate -     fragile) will also be studied.   "
142807|NCT01415245|"     Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and     effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in     patients with coronary heart disease.   "
142808|NCT01415232|"     The purpose of this study is to determine the correlation between actual epidural needle     depth (ND) and the use of ultrasound with an epidural depth equation (EQ-US) to estimate     epidural depth (Est-D) in morbidly obese parturients. It is well documented that in women     with a BMI greater than 40 kg/m2 successful epidural placement is more difficult. To the best     of our knowledge the use of an epidural depth equation, which was developed in an earlier     study using height and weight, with ultrasound visualization will improve identification of     the epidural space.   "
142809|NCT01415219|"     The purpose of this study is to evaluate the efficacy of an active rehabilitation program on     disability and quality of life of patients affected by dermatomyositis and polymyositis.   "
142810|NCT01415206|"     This study is a randomized, controlled, multiple risk intervention pilot study evaluated with     clients recruited from VA Medical Center Substance Abuse Programs. The intervention combines     an innovative online system with interpersonal MI-based coaching delivered in 4 sessions over     12-months time.   "
142811|NCT01415193|"     The purpose of this study is to analyse the ability to selectively block the posterior tibial     nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking     the posterior tibial nerve will give the same post-operative pain relief after total knee     surgery compared to a sciatic nerve block.   "
142853|NCT01414647|"     Dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on     the studies made in animals or cell cultures. The findings regarding the possible decrease of     low-grade inflammation are existing also in humans. Low-grade inflammation has been suggested     to be a mechanistic link between obesity and its consequences on cardiometabolic health. The     aim of the present study is to examine the effect of diet rich in berries on glucose and     lipid metabolism and inflammatory markers.   "
143185|NCT01410214|"     The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus     cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete     resection with EGFR activating mutations and to explore a new treatment strategy for this     subset.   "
142812|NCT01415180|"     Sepsis represents the leading cause of childhood mortality worldwide. However, as distinct     from adult medicine, there exists a large knowledge gap regarding long term health related     quality of life (HRQL) and functional status (FS) following pediatric sepsis. This lack of     sepsis outcomes data is critical because failure to identify children at risk for sepsis     associated HRQL/FS deterioration may delay delivery of crucial rehabilitation medicine     efforts to facilitate recovery. Moreover, failure to identify mechanisms of sepsis associated     HRQL/FS deterioration may impede development of novel, effective interventions for these     children. For the first time the LAPSE investigation will quantify deterioration of HRQL/FS     among children surviving sepsis. We will measure the incidence, magnitude and duration of     HRQL/FS alterations associated with pediatric septic shock, and examine clinical,     sociodemographic, and parent/family factors potentially associated with such adverse     outcomes. Because sepsis affects a heterogeneous group of children, long term morbidity     associated with sepsis likely depends on premorbid health status and parent, family and home     characteristics, as well as children's clinical course during sepsis critical illness.     Mechanisms underlying adverse sepsis outcomes among children are poorly understood at this     time. Clinically multiple organ dysfunction syndrome (MODS)has been clearly linked to sepsis     mortality. To begin to understand pathophysiology underlying pediatric sepsis morbidity, this     investigation will seek to identify evidence for association of HRQL/FS alterations following     sepsis with intensity and duration of sepsis mediated organ dysfunction as well as with     pre-existing comorbidities and parent, family, and home characteristics. Thelong term goal of     this research program is to timely identify children at high risk of sepsis mediated HRQL/FS     deterioration and ultimately to design effective interventions to minimize such risk. The     primary objectives of this investigation are to comprehensively characterize HRQL/FS     trajectory and to critically examine the potential role of sepsis mediated organ dysfunction     as well as pre-existing comorbidities and parent, family,and home characteristics as risk     factors for the adverse outcomes. The central hypothesis is that intensity of sepsis organ     dysfunction will predict magnitude of HRQL/FS deterioration. We also hypothesize that the     trajectory towards baseline HRQL/FS following the sepsis event will also depend on     pre-existing co-morbidities and parent, family, and home, and characteristics. Knowledge of     these potential mechanisms will ultimately facilitate development of targeted interventions     to maximize HRQL/FS among children surviving sepsis.   "
142813|NCT01415167|"     The purpose of this registry is to collect information on patients who are receiving     treatment with Proleukin in an organized way, and to learn more about patient care during and     after treatment.   "
142814|NCT01415154|"     The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial     Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic     worsening in patients who have shown a clinical response to acute TMS treatment.   "
142835|NCT01414881|"     The primary objective of this Phase I exploratory study is to determine the effects of     mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density     lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period,     a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period     with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration     of any given subject's participation will be approximately 40 weeks.   "
143433|NCT01406964|"     The aim of this study is to evaluate the usefulness of a Chlamydia Antibody Test for     screening of tubal factor in patients who undergo artificial insemination.   "
143434|NCT01406951|"     Aims: to explore the value of TREM-1 (triggering receptor expressed on myeloid cells-1)     ,PCT(Procalcitonin), as well as CPIS (clinical pulmonary infection score) in the diagnostic     and prognostic assessment of VAP (ventilator associated pneumonia); and to make a comparison     with WBC (white blood cells) and CRP (C-reactive protein) level as well as SOFA (Sequential     Organ Failure Assessment) Score Methods: There were 92 subjects of sepsis, who were either     receiving endotracheal intubation or had undergone tracheotomy and were exposed to mechanical     ventilation. The subjects were divided into the VAP group (32) and the Non-VAP group (60),     the criterion being the contraction of VAP 48 hours after ICU admission. Etiological culture     was conducted in BALF (bronchoalveolar lavage fluid). And sTREM-1 density was determined by     examining serum sTREM-1, PCT, WBC, CRP and EVC (exhaled ventilator condensate). Meanwhile,     the CPIS and SOFA score were worked out. With a 28-day survival as the demarcation line, the     VAP group was further divided into the survivors group, who stayed alive for 28 days or more     , and the non-survivors group, who died within 28 days. The sTREM-1 and PCT level were     denoted as meridians (range interquartile), while the WBC and CRP level as well as the CPIS     and SOFA score, means±standard deviations (SD).      Results: Averagely, the patients would contract clinically-confirmed VAP 6.9 days after     admission, which was mainly traced to Gram-negative bacilli infection. On the very day of     diagnosis, compared with the Non-VAP group, the VAP group showed a higher level of serum     sTREM-1, PCT, WBC and CRP as well as CPIS and SOFA score（295.6pg/ml vs.143.5pg/ml,     P<0.001；4.5ng/ml vs. 1.4ng/ml，P=0.008；16.7×10∧9/L vs.10.9×10∧9/L, P<0.001；11.5mg/dl vs.     7.7mg/dl，P=0.012； 6.0vs. 1.9, P<0.001；10.0vs. 7.5, P=0.017）, AUC (area under the receiver     operating characteristic curve）turned out as follows :sTREM-1: 0.73（95% CI 0.61-0.85）;PCT :     0.70（95% CI 0.57-0.83）;WBC: 0.73（95% CI 0.60-0.85）.The CPIS score, which was proved by     logistic regression analysis as the sole risky factor to VAP, amounted to 0.96（95% CI     0.91-1.00）. Combined prediction probability containing all the data was calculated in     accordance on the relative regression equation. sTREM-1+WBC+CPIS score proved to be most     reliable for diagnosis. AUC turned out as 0.98. With 0.277 as the cut-off point, sensitivity     measured 0.97, specificity, 0.9 and YDI, 0.87. There were only 5 VAP subjects whose sTREM-1     density could be detected in EVC. The VAP patients were divided into a survivors group (n=15)     and a non-survivors group (n=17) with a 28-day survival as the demarcation line. The     non-survivors group demonstrated a higher PCT level and higher CPIS & SOFA score than the     survivors. （3.0ng/ml vs. 15.3ng/ml，P=0.032；5.4vs. 6.6, P=0.03；8.1vs.11.7 P=0.049). AUC worked     out PCT 0.752（95% CI 0.547-0.956）and CPIS 0.764（95% CI 0.575-0.953）. Calculations on the     regression equation showed the PCT+CPIS score was most reliable for prognostic assessment.     AUC turned out as 0.848. With 0.516 as the demarcation line, sensitivity measured 0.867,     specificity, 0.818 and YDI, 0.685.      conclusion: WBC + CPIS helps improve VAP diagnosis; PCT+CPIS may be used for VAP prognostic     assessment. Taking two items into consideration will be of guiding value in VAP treatment as     well as mortality rate reduction. The sTREM-1 level in EVC，however，may be devoid of value for     VAP diagnosis.   "
142815|NCT01415141|"     Chronic hepatitis C is a major cause of liver disease and is thus an important public health     problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to     treatment with a combination of peginterferon and ribavirin, the most common form of the     virus (genotype 1) is relatively resistant to this treatment. Recently, telaprevir has been     approved by the Food and Drug Administration to be given in combination with peginterferon     and ribavirin. This 3-drug combination boosts the remission rate for genotype 1 hepatitis C     to that seen with other more responsive hepatitis C genotypes treated with only peginterferon     and ribavirin. However, telaprevir has additional side affects such as rash and anemia that     may limit its usefulness. Intriguingly, about one third of patients infected with genotype 1     hepatitis C, who have a specific variation (polymorphism) in the DNA sequence (CC) near an     immune response gene (IL28B), in fact are highly responsive to 2-drug treatment with     peginterferon and ribavirin. This raises the possibility that individuals who have the IL28B     CC polymorphism may not need to be treated with the addition of telaprevir and could     therefore be spared unnecessary side effects. Thus, the purpose of this study is to determine     among genotype 1 hepatitis C patients with the IL28B CC polymorphism the success rate and     side effects of 3-drug treatment compared with 2-drug treatment.      In this study, patients with genotype 1 chronic hepatitis C who have the IL28B CC     polymorphism will be randomly assigned to be treated with telaprevir, peginterferon, and     ribavirin or with only peginterferon with ribavirin. These medications and the procedures     involved, including patient history, physical examination, and obtaining small volume blood     specimens (less than 4 teaspoons) for laboratory testing, are within the scope of standard     management of hepatitis C treatment. All patients will be monitored during treatment with     periodic blood testing (weeks 2, 4, and every 4 weeks thereafter while on treatment, and 24     weeks after stopping treatment) and office visits (weeks 5, 12, 25, 49 while on treatment and     25 weeks after stopping treatment). The success of treatment will be judged by the presence     or absence of detectable virus in blood, as measured by a sensitive diagnostic test (PCR).     The data to be generated will include measurement by PCR of hepatitis C viral loads before,     during, and after treatment, as well as reporting of adverse drug effects.   "
142816|NCT01415128|"     This study will compare the pharmacokinetics of omeprazole, rosiglitazone and desipramine     when administered with a single oral dose of avanafil in healthy male subjects.   "
142817|NCT01415115|"     The trial is designed as a feasibility study to determine the correlation of noninvasive     measurements of AGE with the SCOUT device to diabetes complications.   "
142818|NCT01415102|"     The purpose of this study in healthy people is to evaluate safety, toleration and time course     of plasma concentration of single inhaled doses of PF-05212372.   "
142819|NCT01415089|"     The purpose of this pilot study is to develop a personalized, interactive, and web-based     module for cancer patients and a family caregiver. The three-session module will be designed     to help patients and family caregivers improve their communication and support.   "
142820|NCT01415076|"     Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon     distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted     through the lungs. This reduces the effects of colonic distension and minimizes intracolonic     gas at the end of the examination. The aims of the study were to evaluate the timing of     administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.   "
142821|NCT01415063|"     The combination of transcatheter arterial chemoembolization (TACE) with RFA has also reported     to be an effective treatment for HCC. Studies have shown TACE combined RFA to have better     efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for small HCC     (≤3 cm). However, to our knowledge, there have not been any prospective studies to assess     whether TACE combined sequentially with RFA is more effective than RFA alone for the     treatment of HCC recurrence after curative treatment. We hypothesized that the combination of     TACE and RFA might result in better patient survival than RFA alone. Thus, the purpose of     this study was to prospectively compare the effects of sequential TACE-RFA with RFA alone for     the treatment of recurrent HCC. Recurrent HCC in this study was defined as new tumors in the     remnant liver, distant from the resection or ablation site after curative treatment of RFA or     hepatectomy.   "
142854|NCT01414634|"     Open-label, single center, phase I clinical trial to assess the safety, tolerability and     preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous     peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven     immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS     patients.   "
143186|NCT01410201|"     The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant     (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic     epiretinal membrane (ERM).   "
142822|NCT01415050|"     Multicentered, randomized study of safety and efficacy of whole-body vibration (WBV) as add     on to standard pharmacological treatment of osteoporosis (alendronate 70 mg/ week or     raloxifene 60 mg/day) in post-menopausal women.      After informed consent of the patients has been obtained, each patient's potential     eligibility will be assessed during a Screening Visit. Eligible subjects will be stratified     into two groups: those that are on treatment with alendronate and those that are on treatment     with raloxifene.      Subsequently, at baseline, the patients in each group are randomised to receive either WBV or     no WBV during the first segment of the study. Baseline evaluation of biomarkers of bone     remodelling, fall risk and back pain will be performed before starting the first segment.     Patients will return for efficacy and safety evaluations at week 3 and week 6. At 6 weeks     after baseline the second segment of the study starts: patients that were on WBV during     segment I will be observed for another 6 weeks without WBV, whereas the patients that did not     receive WBV during segment I will now be treated with WBV for 6 weeks in segment II. All     patients will return for additional visits at week 9 and 12 for safety and efficacy     evaluation.   "
142823|NCT01415037|"     The objective of this research is to improve the care of ocular disease and disorders, in     particular the changes in the eye associated with diabetes, by providing clinicians with     dramatically improved ultrasonic images of the entire eye. The research combines advanced     high-frequency, high-resolution ultrasonic annular arrays transducers with new processing     techniques designed to overcome several limits that have been reached with conventional high     frequency ultrasound systems. The investigators propose that diagnosis of eye diseases using     annular arrays can be more effective than the conventional ultrasound images by at least 50%;     i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be     detected with the annular arrays.   "
142824|NCT01415024|"     Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2     ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral,     gaining a responder rate of approximately 70%. However, the physiological agitation of the     left ventricle takes place over two pathways. Therefore single point stimulation might be     insufficient for a dilated, insufficiently and asynchronously contracting left ventricle,     resulting in either insufficient or no response to the therapy.      In the CRT ICD Dual LV study the patients receive a second LV lead in an anterior vein.     When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity     of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If     there is an increase in LV dp/dt, the patients will be stimulated with both leads     permanently. If not they will be stimulated conventionally.      The patients participating in this study are monitored for 12 months after implantation.   "
142825|NCT01415011|"     The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW 2992)     to treat non-small cell lung cancer patients considered unfit for chemotherapy and have     either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.   "
142826|NCT01414998|"     There are currently two sensorimotor replacement products which may be of benefit in smoking     cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the     purpose of this project is to investigate whether these replacements can help to alleviate     tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be     separated into two studies, following the same design and procedures.      Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of     a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool     (e.g. stress ball) which provides no smoking-related cues.      Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking     (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement     which only delivers some of the conditioned sensorimotor cues (i.e. ECs).      The investigators hypothesise that the EC will be more effective at reducing withdrawal     symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the     Denic will be more effective than the EC.   "
142827|NCT01414985|"     The investigators propose to assess the safety and efficacy of a new administration method to     deliver a biologic to children with a form of Batten disease using an experimental gene     transfer procedure. This gene transfer procedure consists of delivering a good copy of the     mutated gene to the nerve cells via a virus. These children are born with genetic changes     called mutations that result in the inability of the brain to properly recycle proteins. The     recycling failure leads to death of the nerve cells in the brain and progressive loss of     brain function. Children with Batten disease are normal at birth but by age 2 to 4 have motor     and vision problems which progress rapidly to death at age approximately 10 years old. There     are no therapies available to treat the disease.      The investigators previous clinical trial used a virus called adeno-associated virus 2 (AAV2)     as the gene delivery system. That study showed that viral delivery of the gene was safe and     showed small, but significant benefits to the recipient. The investigators currently have an     IRB approved protocol which uses a slightly different virus called AAVrh.10 as the gene     delivery system. This 3rd protocol proposes to use the same virus AAVrh.10 as the gene     delivery system and has expanded the eligibility criteria.   "
142828|NCT01414972|"     The aim of this study is the comparison between the effects of supplementation with 25000 IU     preformed vitamin A (retinyl palmitate) or placebo for 4 months on gene expression of T CD4+     lymphocyte in atherosclerotic patients(documented with angiography).   "
142829|NCT01414959|"     The investigators will measure the pharmacokinetics of doripenem in skeletal muscle,     subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care     patients.   "
142855|NCT01414621|"     The purpose of this study is to evaluate whether angiogenesis is decreased in diabetic     patients with coronary artery disease compared to non-diabetics with coronary artery disease.     The protein expression of angiogenic factors will be examined in atrial tissue prior to     initiation of cardiopulmonary bypass in patients undergoing coronary bypass surgery.      The goal of this project is to evaluate the tissue levels of HIF-1, VEGF and angiostatin in     diabetic and non-diabetic patients coming for on-pump coronary artery bypass graft (CABG).   "
143032|NCT01412216|"     The purpose of this study are twofold:        1. To understand the effects of physical inactivity (sedentarism) on vascular function,          insulin resistance and inflammation;        2. To assess the role of a dietary intervention (fish oil) in counteracting the effects of          physical inactivity on vascular function and inflammation.   "
142830|NCT01414946|"     Loss of muscle protein and mass are the main causes of fatigue after bowel surgery which may     result in a longer hospital stay and a higher rate of complications. This problem is     especially important for patients after surgery for bowel cancer because cancer itself causes     a waste of muscle protein. Anesthesiologists can decrease these negative effects of surgery     by choosing the type of pain treatment (analgesia) and by giving nutrition (sugar and     protein). Our group recently observed that optimal pain relief with epidural catheters (these     are placed in the so called epidural space, which lies between the spine and the skin of the     back) in combination with a low calorie protein diet intravenously (through the vein)     maintains the body's protein stores after bowel surgery.      The goal of our new research program is to find out whether this protein saving effect     depends on how protein depleted the patient is before surgery. In other words we would like     to answer the question: do cancer patients who show protein wasting before the operation     benefit more from feeding than patients who show no signs of protein wasting? A second goal     of this program is to find out if we need to use sugar as part of the diet or whether the     infusion of protein alone is sufficient. Just giving protein would make feeding not only     easier but also would avoid the increase in the patient's own blood sugar during and after     the operation, which typically occurs when sugar is given intravenously during that period.   "
142831|NCT01414933|"     High sensitivity to targeted agents has been observed in patients whose tumor cells present a     genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR     mutations) together with addiction to the given target. More recently, activation of     alternative pathways (Kras mutation, PI3K mutations) have been reported as a common     resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).      From these data has emerged the hypothesis that identification of the deregulated pathway     through new molecular tools could allow to propose a more tailored targeted regimen.      Based on these concepts, numbers of phase I/II trials enrich their populations in patients     presenting specific molecular alterations.      High throughput technologies (array CGH, sequencing, gene expression array) identify     deregulated genes. In addition, these technologies determine whether such genomic alterations     are single (expected efficacy of single agent) or multiple (rationale for combination). In a     pilot study that included 135 patients, we recently performed a combination of array CGH and     hot spot mutation array in order to drive patients into phase I/II clinical trials. This     study led to the conclusions that high throughput technologies i. are feasible (80%) and     robust, ii. identify targetable genomic alterations in around 40% of samples.      In the present study, the investigators will perform high throughput technologies to drive     400 metastatic breast cancer patients into specific phase I/II trials.   "
142832|NCT01414920|"     The purpose of this study is to determine the efficacy and safety of TAK-875, once daily     (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus     (T2DM).   "
142833|NCT01414907|"     The purpose of this study is to evaluate the effect of adding the Health Promotion activities     and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and     drug abusers compared to the usual intervention alone.   "
142834|NCT01414894|"     The purpose of our study is to determine how well Triple-H works and how safe it is. The     investigators are hoping to determine the effects of starting the therapy early and to     explore if hypervolemia and/or hypertension are beneficial, and what the optimal target     ranges are.   "
142846|NCT01414738|"     The investigators hypothesize that avoidance of the hippocampal region with WBRT may delay or     reduce the onset, frequency, and/or severity of NCF decline, as measured with clinical     neurocognitive tools.   "
142836|NCT01414868|"     Background: Therapeutic outcomes of leukotriene receptor antagonist (LTRA) vary in     asthmatics，and there's not an ideal and simple way for prediction at present.      Objective：To investigate whether leukotriene D4 bronchial provocation test (LTD4-BPT) could     be an indicator of actual therapeutic outcome of LTRA.      Methods：A single centre, open-labeled trial was performed in 32 asthmatics with positive     LTD4-BPT result for a month. All subjects were categorized according to airway responsiveness     to leukotriene D4（PD20FEV1-LTD4）. Subjects received montelukast therapy (10mg, once per     night), and reassessment was performed (3~5) days after withholding LTRA. The primary     end-point was the difference in monthly PEFR. Secondary endpoints included the difference in     FENO, PD20FEV1-LTD4, PD20FEV1-MCh, pre-test FEV1, ACT score, AQLQ symptom score, week 4     PEFmax and PEFmin as compared with week 1, gradual decrease in the use of salbutamol and the     days without using salbutamol.   "
142837|NCT01414855|"     This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab     [RO5072759 (GA101)] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine,     Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients     will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle,     during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP     chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction     of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of     approximately 15 patients are planned to be enrolled at a subset of investigational sites.   "
142838|NCT01414842|"     Aim of the present randomized controlled multinational trial is the comparison of a novel     biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy,     with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic     overall and cardiovascular stability.   "
142839|NCT01414829|"     Gastric biopsies will be taken to compare different methods of H.pylori disclosure.Standard     methods will be compared to culture.   "
142840|NCT01414816|"     To identify problems/questions about following items in the clinical practice using Betaferon        1. Unknown adverse event (especially serious adverse event)        2. Identification of adverse event occurred in the real practice        3. Factors that may affect the safety of drug        4. Factors that may affect the effectiveness of the drug   "
142841|NCT01414803|"     Although the combination of statin and fenofibrate is one of the options for patients with     combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In     this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and     rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood     glucose control, and blood cell counts.   "
142843|NCT01414777|"     The investigators hypothesize that given prophylactically, intravenous ondansetron will     attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.      Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in     preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo     elective caesarean section will be enrolled.      Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous     ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of     saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy     will randomize and dispense study drug.      Baseline measurements of vital signs will be taken. Otherwise standard management will then     be used:        -  Patients must be NPO for 8 hours        -  Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3          minutes, more frequently if decided by the provider.        -  Standard lumbar puncture in a sitting position the L3-L4 or L4-L5        -  Whitacre pencil-point, 25 gauge        -  Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20          mcg fentanyl        -  Immediately after completing the subarachnoid injection, patients will be laid supine          with left lateral uterine displacement      The sensory level of anesthesia will be assessed in the standard fashion every five minutes     using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0,     no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee     [only feet]; 3, inability to move any joint in the legs).   "
142844|NCT01414764|"     The aim of this study is to establish if the application of autologous conditioned plasma     (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon     repair beginning within two weeks of surgery, can improve patient outcomes over the course of     12 months. These outcomes will be measured by post-surgical pain and function scores,     shoulder strength and range of motion (ROM), and radiological parameters of tendon healing.     Outcome measures will be compared to a control group of patients receiving placebo injections     following surgery (saline plus local anaesthetic).      This study is significant for being the first double blind randomised control trial, using     two PRP injections to examine the efficacy of a PRP preparation following surgical repair of     supraspinatus tendon. The objective is to prolong and enhance the tendon healing response     initiated by surgery.      The research hypothesis is that enhanced tendon healing following the PRP injections will     lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon     compared to the control group.   "
142845|NCT01414751|"     Few studies have explored how specific formats of effectiveness information effect on real     patients' decisions. We only know little about what kind of format would be the optimal to     help patients make well-informed real-life decisions corresponding to their preferences.      The trial is developed in a clinical randomised design to study risk communication in the     shared decision making between general practitioners (GP) and their patients in primary     prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about     treatment effectiveness and their patients' values on patients' tendency to accept and adhere     to the treatment as well as their feeling of content with the choice made. GPs are randomised     to inform about risk and treatment effectiveness by means of either absolute risk reduction     (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires     concerning their content with decisions and reflections. Patients' redemption of     prescriptions during the following week and the first year are recorded through an electronic     database.      57 GPs and 248 patients have been enrolled in the trial.   "
142850|NCT01414686|"     More than half of individuals post-stroke have residual movement disabilities, including     reduced mobility, balance, and increased risk of falling. There is a need for innovative,     long-term and economically-feasible interventions for those with chronic stroke. Recently, a     focus has been placed on the use of virtual reality and interactive gaming as a low cost and     effective manner of treating movement disorders. Yet few studies have investigated     interactive gaming platforms effect on balance following stroke. The proposed study is a     randomized, single-blind, control group cross-over study for individuals with chronic stroke     designed to examine an innovative therapeutic approach by investigating the effects of     commercially-available gaming systems on balance, mobility and fear of falling in a sample of     individuals with chronic motor deficits following stroke.   "
142851|NCT01414673|"     We recently reported the superiority of the natural cycle to a natural cycle controlled by     the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed     embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on     endometrial receptivity.Based on the above findings we conducted the first prospective study     that assesses whether there is a difference in pregnancy rate after intrauterine insemination     (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural     cycles controlled by hCG for final ovulation.   "
142852|NCT01414660|"     Three different white adipose tissue-related disorders, whether due to its excess (obesity),     absence (lipoatrophies) or aberrant distribution (lipodystrophies), are paradoxically able to     induce metabolic insulin resistance syndrome. The respective roles played by quantitative and     qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and muscle insulin     resistance, low-grade fat inflammation and immune alterations are not yet perfectly     understood. In contrast to most organ transplantations that are often complicated by     post-transplantation diabetes, diabetes cell therapy is associated with body weight loss,     which is possibly related to the antiadipogenic effects of mTOR inhibitors (rapamycin or     sirolimus). The aim of this study is thus to determine and monitor blood interleukin-7 and     other cytokine levels; metabolic parameters; and fat mass distribution with DEXA and RMN,     before and after a immunosuppressive regimen in patients receiving different kinds of     transplantation (liver, kidney or islets) with normal weight and no type 2 diabetes before     transplantation. In these patients, blood samples will be taken before and after     transplantation, as will adipose tissue during the transplantation surgery, in order to     constitute a plasma serum, gene and tissue bank for improving our knowledge of disorders     linking fat mass, insulin resistance and immunity, especially post-transplantation diabetes.   "
142868|NCT01414439|"     This study will examine the efficacy of group therapy utilizing the Existential Approach in     heart failure patients when compared to a control group of patients who are waiting for the     same group treatment. This comparison will be achieved by measuring changes in the variables     studied namely, the levels of psychological distress and levels of psycho-social adjustment.   "
142856|NCT01414608|"     This randomized phase III trial studies how well giving cisplatin and radiation therapy     together with or without carboplatin and paclitaxel works in treating patients with cervical     cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in     chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop     the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from     dividing, or by stopping them from spreading. External radiation therapy uses high-energy x     rays to kill tumor cells. Internal radiation uses radioactive material placed directly into     or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and     external and internal radiation therapy together with carboplatin and paclitaxel kills more     tumor cells.   "
142857|NCT01414595|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research trial studies tissue samples from patients with non-small cell lung     cancer.   "
142858|NCT01414582|"     This study aims to test whether repeated sessions of tDCS result in long-lasting improvements     in motor function in patients with chronic stroke.   "
142859|NCT01414569|"     The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective     as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.   "
142860|NCT01414556|"     Investigation of GIP effects at fasting and hypoglycemia   "
142861|NCT01414543|"     The objective of the proposed research is to gain a detailed understanding and account of     psychologists' experience of client violence in clinical practice. The emphasis is upon a     detailed understanding of how psychologists perceive and understand their experience of     client violence and its impact upon their identity as clinicians and as individuals.   "
142884|NCT01414218|"     1. Senior citizens living in the community who participate in a humor seminar will have          improved health quality of life compared to those not participating in the seminar.        2. Senior citizens living in the community who participate in a humor seminar will have          improved general well being compared to those not participating in the seminar        3. Senior citizens living in the community who participate in a humor seminar will have          decreased psychological distress compared to those not participating in the seminar   "
142862|NCT01414530|"     Muscle or joint pain is one of the most common symptoms during menopausal transition. As this     could be severe enough to affect social and daily life and to reduce quality of life,     attentions should be paid about this.      Although understanding of muscle or joint pain related to menopause is still insufficient,     estrogen can play an important role. Previous studies have shown that estrogen protects     cartilage in both animals and humans.      However, perimenopause is different from postmenopause, in the point that estrogen is still     secreted with a great fluctuation.      Until now, no study has been performed to evaluate the effects of oral contraceptive on     muscle or joint pain in women during menopausal transition. Moreover, since menopausal     symptoms vary according to ethnicity and culture, a study in Korean population is necessary.      Therefore, this randomized controlled trial was designed to evaluate the effects of oral     contraceptive on muscle or joint pain in women during menopausal transition, compared to     NSAID (non-steroidal anti-inflammatory drug).   "
142863|NCT01414517|"     The study will consist of pair of double-blind placebo-controlled trials of dietary     supplementation with 15g/day FructoOligoSaccharide (FOS) for 7.5 weeks in patients with     prostate carcinoma or 5 weeks in patients with cervical or endometrial carcinoma who are to     undergo pelvic radiotherapy with intent to cure.   "
142864|NCT01414504|"     Recently, controversy has emerged regarding the role of the 23vPPV in infants due to     potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat     vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated     protective efficacy against acute lower respiratory tract infection, the investigators feel     it is a matter of urgency to determine if 23vPPV administration provides elevated antibody     concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV     in infants.      Following consent and eligibility assessment, a baseline blood sample and nose swab will be     taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab     will be collected 28 days later. The investigators will also collect data on incidence of     ALRI in all study participants by medical record review.   "
142865|NCT01414478|"     The purpose of our study is to determine if the incidence of emesis can be lowered with the     addition of a high protein drink during labor. Emesis and nausea are the leading causes of     parturient dissatisfaction, results in a delay of returning to normal, daily living and can     hugely impact the mother's postpartum experience. To date, no studies have been done on the     relationship of protein intake during labor and incidence of emesis. To the best of our     knowledge, the use of a high protein drink during labor has not been evaluated in the     literature.   "
142866|NCT01414465|"     Orlistat is a popular drug approved for long-term use which produces weight loss by     inhibiting triglycerides, main components of fats in the diet and reducing dietary fat     absorption by up to 30%. The effect of this drug on human blood fatty acid profile has not     been described yet. The FA composition of RBCs, plasma and platelets can be used to monitor     of many pathological processes. This study presents alteration of FA composition in RBCM and     phospholipids, triglycerides and cholesteryl esters from plasma of health obese female     volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.   "
142867|NCT01414452|"     There is experimental evidence that low levels of adiponectin are associated with more     reperfusion injury. In addition experimental studies have demonstrated that endothelial     progenitor cells may have a favorable effect on remodeling, mainly through stimulation of     neo-revascularisation. Clinical data on these issues are lacking. This clinical project     studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles     in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a     population of 250 infarction patients treated with primary PCI. If the role of these factors     could be confirmed in this clinical setting, those factors might represent a new target for     therapeutic interventions in AMI patients.   "
143187|NCT01410188|"     This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in     the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in     subjects with primary open-angle glaucoma or ocular hypertension.   "
142870|NCT01414413|"     Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence     countries, the majority of people with HIV infection still initiate treatment at an advanced     stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV     diagnosis is, therefore, necessary for both individual and public health benefit and is being     strongly promoted as international and national policy in Malawi. However timely HIV     diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the     relatively high proportion of individuals who defer treatment-seeking for months or years     following diagnosis of HIV.      Here the researchers investigate the extent to which home assessment and initiation of ART     adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry     to, adherence with, and retention in HIV care as the outcome of interest.   "
142871|NCT01414400|"     The aim of this study is to prospectively evaluate the frequency of bacteremia after     ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the     frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.   "
142885|NCT01414205|"     This open-label, multicenter, randomized study compared the efficacy, safety and     pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants     with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles     (28-day cycle) of obinutuzumab (1000 mg intravenous [IV] infusion, on Days 1, 8 and 15 of     Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of     obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each     subsequent cycle up to 8 cycles.   "
143435|NCT01406938|"     This study will assess the safety and efficacy of two different doses and two different dose     regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic,     plaque-type psoriasis.   "
142872|NCT01414387|"     Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment for     narrowing of the carotid arteries in patients at high risk for open surgery. Special devices     are used to protect the brain from particles(emboli) that may break off when the narrowing or     blockage is cleared during the angioplasty and stenting procedure. Although filters are most     frequently used, protection systems consisting of balloons and flow reversal are also     available for cerebral embolic protection. However, there is little information about the     effectiveness of filters compared with balloons and flow reversal for prevention of     embolization during CAS. The aim of our study is to address this major problem. Our study was     designed to answer two specific questions: First, the study will investigate whether     balloon-based protection systems are more effective than filters in reducing the amount of     particles that break off and travel to the brain during CAS. For this purpose two imaging     techniques will be used: magnetic resonance imaging of the brain (MRI), and transcranial     doppler (detection of microparticles in the small brain vessels using ultrasound). Second, it     will be investigated whether the use of balloon-based protection devices are more effective     than filters for prevention of stroke, heart attacks, and death after carotid stenting. The     results of the study will provide important information to find out the best way to protect     the brain from plaque fragments that may break off during CAS.   "
142873|NCT01414374|"     The study aims to investigate the prevalence of genetic polymorphisms in adults with iron     deficiency and anemia, and the responses to two different treatments: iron sulphate and a     composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome will     be hemoglobin, measured before and after 6 weeks.   "
142874|NCT01414361|"     Recent studies have shown that optimal IVUS criteria defining the functional significance     (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of     the coronary tree. Herein, the investigators performed this study to validate these results     and to generalize the IVUS criteria defining functional significance of intermediate coronary     stenosis in a different location of coronary tree in a larger sample size.   "
142875|NCT01414348|"     Successful community participation following acquired brain injury (ABI) continues to be an     elusive goal for patients, clinicians and researchers. Our pilot work shows that community     dwelling survivors of ABI can significantly improve performance on self-identified real-     world performance problems and that they can transfer this learning to improve goals not     trained in the treatment sessions. We will compare two types of rehabilitation intervention     using a randomized controlled trial. We will also interview survivors, their significant     others and clinicians regarding their experiences with each intervention to help us discover     what works best.   "
142876|NCT01414335|"     The purpose of this study is to investigate the effectiveness of a dietary supplement with     high dosage of amino acids and vitamins in the treatment of acute and chronic infection of     pharyngeal area known as common cold. T   "
142877|NCT01414322|"     Phenotype characterization of shortness of breath of pediatric emergency room patients by     objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy     and correlates with overall patient outcomes.   "
142878|NCT01414309|"     Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs     in patients with heart failure (HF). The primary purpose of this study is to document the     natural progression of moderate to severe CSA in heart failure patients.   "
142879|NCT01414296|"     Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an     open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects     with progressive CMPC that has progressed after prior taxane therapy. Subjects who have     participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from     continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.   "
142880|NCT01414283|"     Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label,     dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive,     castration-resistant, metastatic prostate cancer that has progressed after prior taxane     therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.   "
142881|NCT01414257|"     This Investigation is to be performed for the purpose of assessing the following information     in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX     2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher than 8     mg/week.        1. Condition of occurrence of ADRs        2. Factors considered to affect safety        3. Verification of efficacy   "
142882|NCT01414244|"     New and effective treatments are needed for patients with post-infectious irritable bowel     syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy     and safety of glutamine, an abundant amino acid in the body and the principal fuel for     enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with     increased intestinal permeability following an enteric infection.   "
142883|NCT01414231|"     This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is     compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis     involves primarily dosing and application of AraC for induction. It is expected that CR rates     and as a consequence also LFS are higher in protocols using higher AraC compared to lower     doses and that LFS might be superior in the study specific arm compared to the golden     standard published several years ago. In the standard arm, AraC 100mg/m2/day is given as     continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two hours     infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After reaching     CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5. In     contrast the OSHO arm consists of induction therapy with IDA 12 mg/m*2 over 20-30-min-iv on     day 1 - 3 and AraC 2 x 1 g/m*2 bid over 3-h-iv on days 1+3+5+7.      A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using     MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly     diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients     are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates     evaluated.      It is still unclear if two consolidation therapies are needed before allogeneic or autologous     stem cell transplantation. This question is being addressed in the second part of the OSHO     study, where patients are randomized to receive either one or two consolidation therapies.      In this study all patients with AML and an age of 18-60 years except M3 are entered   "
142887|NCT01414179|"     Introduction. The cardiovascular diseases, at the origin of 4 deaths out of 10, remain the     leading cause of mortality in Europe. According to WHO, this tendency will spread in 2020 on     a worldwide scale. These pathologies are avoidable on the whole by the adoption of healthy     lifestyles. To prevent occurred of the cardiovascular affections is, more than ever, a major     goal of Public health. The transborder Great Area, localised zone in the middle of Europe     between the very high cardiovascular risks of the North and the weaker risks of the South,     constitutes a zone privileged for the action against the cardiovascular diseases. However,     there to date does not exist any joint action in this geographical area. The Public Research     centre of the Health of the Grand-Duchy of Luxembourg, the School of Public health of the     University of Liege, the Clinical Center of Investigation of the University hospital of Nancy     and the University hospital of the Saar wish to be linked and mutualiser their means     available and their complementary competences in order to evaluate and to act on the     cardiovascular health of the citizens of the Great Area. Over one 3 years period the     Nutrition project, Environment and Cardiovascular Health (NESCAV) aims at creating on the     level of the Great Area a transborder alliance of prevention and promotion of cardiovascular     health. This great multicentric transverse investigation and poly-set of themes will make it     possible to collect relevant data on cardiovascular health of the population of the Great     area.      Objective of this biomedical research project: It is about multicentric, transverse a     Européenne epidemiological study aiming, through biological questionnaires and analyses, to     collect information on the cardiovascular risk factors within the Great Area.   "
142888|NCT01414166|"     The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination     tablets in a primary prevention population currently not taking or eligible for     lipid-modifying therapy (LMT); the population will comprise participants with low to moderate     risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low     density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated     triglyceride (TG) levels.   "
142889|NCT01414153|"     The purpose of the study is to determine the safety and efficacy of 4 monthly injections of     iSONEP given alone or in combination with Lucentis, Avastin or Eylea in subjects with wet     Age-related Macular Degeneration (AMD). iSONEP not only has an anti-permeability effect, but     also has anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. The drug may     therefore have the ability to achieve better visual outcomes than Lucentis, Avastin or Eylea,     particularly in those subjects who do not demonstrate a robust response to Lucentis, Avastin     or Eylea after several monthly injections. Further, the combination of Lucentis, Avastin or     Eylea and iSONEP may be additive or synergistic. By inhibiting the multiple mechanisms that     contribute to exudative-AMD-related vision loss, better visual outcomes may be possible than     with Lucentis, Avastin or Eylea alone.   "
142890|NCT01414140|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of women who are inserted Mirena for intrauterine     contraception. The objective of this study is to assess safety and effectiveness of Mirena     under real-life practice conditions. A total 550 patients will be recruited and followed for     5 years.   "
142891|NCT01414114|"     The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV)     administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in     hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).   "
142892|NCT01414101|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of     ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in     subjects with active rheumatoid arthritis.   "
142893|NCT01414088|"     The kidneys have numerous salt and water channels and play a major role in the regulation of     sodium and water. We do not know how these channels work in certain water and sodium     accumulating medical conditions.      The purpose of this study is to identify and measure the activity in the water and sodium     channels by measuring urine biomarkers/proteins in young healthy subjects.   "
142894|NCT01414075|"     The purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of     anemia in patients with end-stage renal disease who recently started dialysis.   "
143127|NCT01410968|"     The purpose of this study is to provide a safety and feasibility basis for future studies     addressing the hypothesis that subcutaneous vaccination with dendritic cells loaded with     multiple antigenic epitopes expressed by pancreatic tumor in combination with systemic     administration of Poly-ICLC (Hiltonol) will induce anti-tumor immunity.   "
142895|NCT01414062|"     Hispanic women are 20% more likely to die of breast cancer than non Hispanic white women who     are diagnosed at a similar age and stage. One reason for this disparity may be differences in     post diagnosis dietary behaviors. In order to reduce this disparity, and to improve overall     survivorship, culturally appropriate dietary interventions that teach women how to eat a diet     high in fruits and vegetables and low in saturated fat need to be developed for Hispanic     breast cancer survivors. The investigators propose to conduct a randomized controlled study     (n=70, 35 per arm) to test the effects of the ¡Cocinar para su salud! program on changing     dietary behaviors among Hispanic breast cancer survivors who have recently completed     treatment. The ¡Cocinar para su salud! program is a 12 week course that provides hands on     education and instruction in nutrition education, meal preparation, and food shopping in a     group setting. All participants will be followed for a total of 12 months, have clinical     assessments at baseline, 6 months, and 12 months, and monthly telephone contacts using     motivational interview techniques. The Primary Aims are to determine the effect of the     dietary intervention (¡Cocinar para su salud! program) vs. control (standard written     nutrition education materials for cancer survivors) on 1) daily servings of fruit/vegetable,     and 2) daily servings of fat intake from baseline to 6 months. The investigators hypothesize     that the dietary intervention will result in a larger increase of fruit and vegetable intake     and a larger reduction of fat intake, when compared to the control group. Secondary Aims are     to determine the effect of the dietary intervention vs. control on 1) biomarkers of fruit and     vegetable intake, molecular biomarkers associated with breast cancer risk, and anthropometric     measures at 6 and 12 months; 2) fruit/vegetable and fat intake at 12 months; 3) mediators of     dietary change, including readiness to change, outcome expectations, perceived self efficacy,     food and nutrition skills, self regulation skills, and barriers to adherence; and 4) changes     in quality of life and anxiety/depression at 6 and 12 months.   "
142907|NCT01413867|"     Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of     less postoperative pain compared with excisional surgery, however a still relevant percentage     of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler     device has been designed to overcome these drawbacks by modifying the stapled sutures and by     increasing the space for mucosal resection in the case of the stapler.      This randomized controlled study was aimed to demonstrate whether the new EEA stapler     Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03     Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if     the modified stapled sutures can ensure better intraoperative hemostasis by measuring the     number of overstitches required to get perfect hemostasis during the operation.   "
142908|NCT01413854|"     The purpose of this study is to determine whether diclofenac is effective in the treatment of     depressed patients with a recent suicide attempt.   "
142896|NCT01414049|"     Heart bypass surgery is used to increase blood flow to the heart. This surgery is usually     done using a heart-lung machine (on-pump surgery) allowing the surgeon to perform the     procedure on a still heart. However, this heart-lung machine causes an inflammatory response     and is linked with complications such as heart injury, stroke, brain injury, kidney failure,     need for blood transfusions, irregular heart rhythms and death. An effective way of     counteracting the effects of the heart-lung machine is to not use the pump itself, thus     performing the bypass surgery with a beating heart (off-pump surgery). However, off-pump     surgery is technically more difficult, possibly associated with a decrease in graft patency.     The ongoing Coronary Artery Bypass Graft Off or On Pump Revascularization Study (CORONARY),     is a prospective randomized clinical trial comparing bypass surgery done with and without the     pump. Worldwide, 4700 patients will be included and followed up for 5 years. The proposed     research project, The Patency AssessmenT of grafts pErformed iN CORONARY (PATENCY-CORONARY),     is a prospective clinical trial for the evaluation of patency (or openness) of the bypass     grafts that will enrol 1200 consecutive CORONARY patients reaching their one year follow-up.     Patients will undergo a non-invasive scan using X-rays to safely and quickly evaluate graft     patency. The PATENCY-CORONARY trial will determine if off-pump surgery is associated with     decreased graft patency at 1-year post-surgery compared to on-pump surgery when performed by     skilled surgeons in different clinical settings, whether decreased graft patency is     associated with adverse short and long-term outcomes, and explore other risk factors     associated with decreased graft patency.   "
142897|NCT01414036|"     Cigarette smoking is a highly significant health threat, responsible for more than 430,000     deaths each year. Low-income persons and racial/ethnic minorities are at particularly high     risk, smoking at greater rates and having greater tobacco-related morbidity and mortality     than other persons. Yet poor and minority smokers are less likely to receive advice to stop     smoking or to use tobacco cessation services. Using non-physician members of the health care     team as patient navigators to connect low-income and minority smokers to evidence-based     tobacco treatment services is a promising approach because 1) many primary care providers     (PCPs) are unable to provide counseling to patients who smoke due to time constraints; 2)     minority patients may be less aware of smoking cessation resources and may have     misconceptions about tobacco dependence treatments; and 3) as primary care practices are     redesigned as medical homes, non-physician members of the health care team will increasingly     be taking on tasks previously performed by PCPs. Patient navigators are lay persons from the     community, working as paid employees, who are trained to guide patients through the health     care system to receive services. Information on the efficacy of patient navigation to connect     vulnerable patients to smoking cessation services is needed.      The investigators will implement a patient navigation-based intervention in the primary care     setting to promote engagement of low-income and minority patients in smoking cessation     treatment. To test our intervention, the investigators will conduct a pilot randomized     control trial (RCT), randomizing 240 patients to the intervention condition (patient     navigation) or an enhanced traditional care (ETC) control condition. The investigators will     perform follow-up at three months following the start of the intervention, with a primary     outcome of engagement in smoking cessation treatment.   "
142898|NCT01414023|"     This experiment will examine if the use of computerized tasks that train individuals to     control their attention more effectively will predict individual differences in     obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out     self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to     Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which will     be administered three times over a two week period. At the third visit, participants will     also complete an anagram task and repeat the blood draw for BDNF testing. The investigators     hypothesize that computerized tasks that train individuals to control their attention more     effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally, individuals     training in CCT will show increased ability to disengage from unattainable goals as assessed     by responses to an unsolvable anagram task. Finally, individuals training in CCT will show a     greater increase in BDNF levels as compared to individuals training in PVT.   "
142899|NCT01414010|"     The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes     Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut     microbiota of healthy volunteers. It is expected that treatment will result in the rapid and     reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks     after treatment is discontinued.   "
142900|NCT01413997|"     The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure     (CTMM) -quantifying the functional behavior of perimuscular connective tissues.   "
143176|NCT01410331|"     This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy     of JVS-100 given to adult subjects with critical limb ischemia (CLI).   "
142901|NCT01413984|"     The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma     (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft,     Oklahoma. The purpose of the proposed study is to expand previous findings by including a     comparison group of women that are not receiving treatment but are otherwise eligible, and by     using outside evaluators to conduct the assessments. Furthermore, this study will extend the     outcomes measured in previous evaluations by including measures of sleep disturbance,     posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The     hypotheses for this study are listed below:        1. Incarcerated women with substance use disorders and history of trauma enrolled in the          integrated treatment program (HWR plus BT) will report significantly fewer symptoms on          measures of posttraumatic stress and associated cognitions, substance use, depression,          and related symptoms following treatment than those in the comparison group.        2. Those in the treatment group will improve significantly more than those in the          comparison group on the symptoms listed above.   "
142902|NCT01413958|"     This study will compare the nasal congestion symptom relief of phenylephrine extended release     tablets and placebo in participants with allergic rhinitis.   "
142903|NCT01413945|"     The aim of the current study is to test the hypothesis that patients with IBS may have a     defective ICV pressures and may have small bowel bacterial overgrowth. The goal of the     current study is to identify the role and competence of ileocecal valve (ICV) in patients     with irritable bowel syndrome.      The primary objective is to measure the pressure of the ileocecal valve in patients with and     without irritable bowel syndrome (IBS). The Ileocecal valve reflux pressures during air     insufflation of cecum will be used.   "
142904|NCT01413932|"     This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,     and pharmacokinetics of HT-2157 in healthy normal volunteers      Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose     evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in     patients with major depressive disorder   "
142905|NCT01413906|"     The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923     (XL139) when orally administered on a once daily schedule.   "
142906|NCT01413893|"     An extension study of linifanib in subjects with advanced or metastatic solid tumors.   "
142909|NCT01413841|"     Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary     Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this.     In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent     Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with     acute myocardial infarction (with normal blood saturation. The investigators therefore wanted     to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.   "
142910|NCT01413828|"     Most of the published data support the preferential use of an anthracycline-containing     adjuvant regimen for individuals with HER2-positive tumors. Concurrent anthracyclines and     trastuzumab, however, are contraindicated due to the observation of unacceptably high rates     of cardiotoxicity in a large randomized trial in the metastatic setting. However, in     neoadjuvant setting, trastuzumab concurrently with an anthracycline-containing chemotherapy     regimen had shown high pathological complete response (pCR) and very low cardiotoxicity. All     large adjuvant trials have evaluated only the sequential strategy of administering     anthracyclines and trastuzumab. The safety and efficacy of trastuzumab concurrently with an     anthracycline-containing chemotherapy regimen has never been evaluated in adjuvant setting.     Given the similar patients characteristics, the investigators hypothesize that trastuzumab     concurrently with an anthracycline-containing chemotherapy regimen would not increase     cardiotoxicity but efficacy.   "
142911|NCT01413815|"     The aim of the study is to test whether pre-operative oral supplementation with L-arginine     results in a significant reduction of peri-operative cardiovascular complication rate in     unselected patients undergoing major abdominal or thoracic (non-cardiac) surgery. The second     aim of the study is to assess whether pre-operative determination of plasma ADMA levels     allows to identify patients who are at high risk of experiencing a peri-operative     complication, and whether this subgroup of patients profits specifically from pre-operative     L-arginine supplementation.   "
142912|NCT01413802|"     During thyroid surgery the laryngeal recurrent nerves (and for this reason the voice quality)     are at risk. Therefore intra operative continuous neuromonitoring could help to prevent harm     to these nerves. Electromyographic data (EMG values) are collected during surgery (1). In the     postoperative follow-up period detailed voice analysis is performed (2): subjective auditive     perceptive evaluation and videostroboscopy. Analysis and comparison of (1) and (2) will be     performed in order to find out if we can find a predictive correlation between the EMG data     (1) and the voice quality (2).   "
142913|NCT01413789|"     Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and     hydration?      For this study 16 volunteers and ten patients with healed full thickness burns will be     included.      After a short period of acclimatization four test areas will be determined. For healthy     volunteers the standard zones are located on the inner forearm, two on each forearm.      For patients with healed burns the 4 test zones are located on either the healed donor site     or the healed skin grafted area.      In each test zone baseline measurements will be taken before application of the     products.After application of the three silicone gels and the hydrating gel cream the trans     epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured     by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage & Khazaka).   "
142914|NCT01413776|"     The study will evaluate the effects of a nutrition supplement for pregnant women on birth     weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified     food supplement will produce babies with a higher mean birth weight than those who do not.   "
142915|NCT01413763|"     The purpose of this study is to determine the potential effect of topically applied 3.75%     imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. The primary endpoint is     the change in the 24-hour supraventricular premature beat count. The secondary endpoint is     the change in 24-hour supraventricular premature couplet and run counts and atrial     fibrillation (% time); change in 24-hour mean heart rate; change in 24-hour ventricular     premature beat count, ventricular premature couplet and run counts.   "
142916|NCT01413750|"     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel     together is more effective with or without vorinostat in treating non-small cell lung cancer.   "
142917|NCT01413737|"     This is a retrospective, descriptive analysis of (1) 30 day postoperative results of surgery     for lung cancer, (2) 30 day outcome predictors - compared to an earlier similar study in the     same hospital (St Olav University Hospital, Trondheim, Norway).   "
142918|NCT01413724|"     The study is a national survey of pain and pain management to surgical patients in Norwegian     Hospitals. Data on pain management are gathered from patient records and data on pain and     patient satisfaction are gathered as patients' self report.   "
142919|NCT01413711|"     The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in     neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of     vigabatrin.   "
142920|NCT01413698|"     People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients     suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.      Treatment of cough in these patients consists of many types of expectorants, cough     suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical     therapy (PT) is often prescribed as part of the treatment regime.      The assessment of coughing is currently subjective and based on the symptoms qualitative     description as expressed by the patient or parent. Quantitative and objective methods for     cough assessment are not available beyond the investigative laboratory and are unique to the     specific investigator.   "
142921|NCT01413685|"     The purpose is to define if calcineurin activity is a better biological parameter than blood     concentration for the therapeutic tacrolimus monitoring.   "
142922|NCT01413672|"     The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin     environment will result in reduced peristomal skin irritation.   "
142923|NCT01413659|"     The objective of the study is to investigate whether peri-operative symbiotic treatment could     reduce the risk of postoperative infections in patients undergoing elective colorectal     surgery. This study was also designed to assess the risk-adjusted incidence and predictors of     surgical site infections.   "
142926|NCT01413620|"     Burned patients because of their increased oxidative stress have severely depleted vitamin E,     which is a dietary antioxidant. Oxidative stress is responsible for much of the     pathophysiology seen in burned patients, which leads to acute and chronic morbidity and     mortality, in addition to a decrease in their quality of life. Oral vitamin E will be used to     reverse the oxidative stress of burn injury and, in the process, decrease the secondary     consequences of thermal trauma. This proposal will demonstrate the benefit of maintaining     adequate vitamin E status.   "
142927|NCT01413607|"     The objective of this study is to assess whether using a different type of suture (barbed     sutures) during partial nephrectomy results in fewer postoperative complications than with     traditional sutures (non-barbed). The most common complications are urine leakage and     bleeding. The investigators believe the barbed suture is less technically difficult to use     and will allow the surgeon to better repair the hole left in the kidney after the tumor is     removed.   "
142928|NCT01413594|"     A randomized control trial of bimanual training in children with hemiplegia. The protocols     have been developed at Columbia University to be child friendly and draws upon our experience     since 1997 with constraint-induced movement therapy in children with cerebral palsy. The     investigators will test the hypothesis that bimanual training (HABIT) will result in improved     hand function in children with hemiplegia.   "
142929|NCT01413581|"     The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as     compared with placebo.   "
142930|NCT01413568|"     Determine the safety and tolerability of POL6326 when used as a single mobilization agent.   "
142931|NCT01413555|"     False positive blood culture results due to specimen contamination with bacteria inhabiting     patients' skin is a common problem in emergency departments (EDs) in the United States.     Contaminated blood cultures lead to patient harm through unnecessary hospitalizations and ED     visits, delays in surgery, unneeded antibiotics, and unnecessary procedures. The     investigators have developed a multifaceted quality improvement improvement bundle (The Blood     Culture QI Program) designed to minimize blood culture contamination in the ED. In this     study, the investigators will implement the quality improvement bundle in six community     hospital EDs and evaluate its effectiveness at reducing contamination.   "
142932|NCT01413542|"     The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4     inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people     receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure     medicine. Understanding how these drugs interact in healthy people will help us learn their     potential effects in people who have diabetes.   "
142933|NCT01413529|"     HIV infected drug users have greater difficulty adhering to highly active antiretroviral     therapy compared to non-drug users. As sustained adherence to highly active antiretroviral     therapy is critical to reducing HIV related morbidity, mortality, and reducing the spread of     HIV, innovative and potentially sustainable treatment strategies that can optimize the     durability of adherence enhancing interventions among drug users is urgently needed. The goal     of this study is to further develop and pilot test a smartphone based intervention called     HEART (Helping Enhance Adherence to Retroviral therapy using Technology) to HAART, to enhance     adherence to HAART among HIV infected drug users.   "
142934|NCT01413516|"     This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study     that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr)     smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).   "
142935|NCT01413503|"     This is an ongoing prospective Phase II clinical trial evaluating the efficacy of 131I-MIBG     for the treatment of patients with metastatic or unresectable pheochromocytoma and related     tumors.   "
144526|NCT01392690|"     The purpose of this study is to assess the impact of a primary prevention program for anxiety     disorders.      This study was completed between 2000 and 2002, with the final report transmitted to the     Quebec ministry of health in 2003.   "
142936|NCT01413490|"     Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide.     Current treatment of hepatitis C infection is only successful in about half of those who are     eligible. The current treatment aims to boost the host immune system but does not directly     act on the virus. Many drugs are in various stages of development that target the virus     directly - their specific mode of action is confirmed by showing the virus is forced to adapt     in the presence of the drug. As with many viruses, treating with only one specific drug would     quickly lead to the virus adapting and becoming resistant. We therefore need to find new     combinations of directly acting drugs. Rimantadine has already been shown in the laboratory     to target hepatitis C directly. We have designed this study to see if it happens in real life     as well. If so, we could use rimantadine to help fight hepatitis c more effectively.   "
142937|NCT01413477|"     Nickel contact dermatitis (eczema) is one of the most common allergic conditions affecting     the skin. This is a study looking at potentially desensitizing nickel-allergic patients to     their allergy using anti-inflammatory ointments applied to the skin (arm). Application of     these ointments (ie. modified Vitamin D) has been shown to increase specific immune cells (T     regulatory cells), which play a role in preventing immune activation and subsequently     inflammation. The investigators propose use of topical anti-inflammatory agents     (corticosteroids, modified Vitamin D, or both) may desensitize patients with nickel allergy.   "
142948|NCT01413334|"     Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test,     accurately evaluate anatomic coronary artery stenosis. However, anatomically-obstructive     coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific     ischemia. Recently, with the advance of imaging reconstruction and analysis technique,     several novel parameters computed from CCTA were suggested to have added value in determining     the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal     attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the     presence of hemodynamically-significant coronary stenosis, as determined by fractional flow     reserve (FFR).   "
142956|NCT01413230|"     Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the     skin, the joints, the nervous system and the kidney and may be life threatening.      SLE is associated with production of autoantibodies and perturbations in regulatory T cells     and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).      Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.      Immunomodulatory effects of vitamin D supplementation in VITRO was recently described,     notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and     CD8+ T cells and the decrease of Th17 cells.   "
142938|NCT01413464|"     Clots that develop in the deep veins of the legs or the lungs can result in pain, heart and     lung disease and may lead to death if unrecognized or not treated. Risk factors for     developing clots include surgery, hospitalization and/or being immobile. Up to 10 to 40% of     people may develop a clot during or after their hospital stay or surgery, and sometimes these     clots do not cause symptoms. In order to help reduce the risk of developing a clot in the     legs or lungs, many people undergoing surgery receive a small dose of a blood thinner in     hospital after their surgery is completed. Although prescription of a low dose blood thinner     is routine practice after most surgeries, the risk or benefit of blood thinners after kidney     transplant surgery is still not clear. Given this, many transplant physicians differ in     prescribing practices of low dose blood thinners after kidney transplant surgery. More     information is needed about the risk of clotting and bleeding in people after kidney     transplant surgery so that physicians can become more unified in deciding whether a low dose     blood thinner would protect patients after kidney transplant without producing harm.      The REPORT study is designed to examine the risk of clotting in the legs or lungs in people     after kidney transplant surgery as well as the risk of bleeding. Ultrasounds of the legs will     be performed at various time points after surgery for up to one year to screen for blood     clots. People participating in this study will also be screened and monitored for bleeding     after surgery. Although this study will also examine the prescription practices of     physicians, no blood thinners will be given or withheld from participants as a result of this     study. Physicians will prescribe blood thinners as per their usual practice after kidney     transplant. Overall, the goal of the study is to find out how frequent clotting and/or     bleeding is after kidney transplant surgery, which will help in making recommendations     regarding the use of low dose blood thinners in people after their surgery.      Ultrasound scanning of the legs is a safe test that does not cause physical pain and has no     risk of causing injury. Participation in this study will provide the benefit of additional     monitoring with several ultrasound tests after surgery, screening for clots in the legs which     can cause health risks and even death if unrecognized. If a clot is found, it will be treated     promptly and according to current medical standards under the care of a specialist.      In the long term, the results of this study will help improve health care delivery to people     undergoing kidney transplant with the goal of decreasing potential complications such as     clotting and/or bleeding. Currently, there are no guidelines available to guide physician's     in the use of a low dose blood thinner after kidney transplant surgery. This study will help     determine the risk of clotting or bleeding and help us make recommendations that will reduce     potential risks and complications for people undergoing kidney transplant in the future.   "
142939|NCT01413451|"     Background:      - Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this     substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab     helps the immune system to kill cells that have high levels of mesothelin. However, more     research is needed to determine how safe and effective amatuximab is for treating tumors with     high levels of mesothelin.      Objectives:      - To assess the safety and effectiveness of amatuximab in treating tumors with high levels of     mesothelin.      Eligibility:      - Individuals at least 18 years of age who have a type of cancer that overexpresses     mesothelin.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood tests and tumor assessment studies.        -  Participants will have two intravenous doses of amatuximab several hours apart.          Researchers will monitor them closely and do frequent blood draws. On the same day and          also within 48 hours of the second dose, participants will have imaging studies. These          studies will measure how well the amatuximab is working against the cancer.        -  Participants will have a third imaging study of the cancer about 1 week after the          infusions.        -  Participants will have a followup visit 2 weeks after receiving amatuximab. This visit          will require blood samples. Four weeks after receiving the drug, researchers will review          patients symptoms or side effects. This interview can be done in person or by phone....   "
142963|NCT01413126|"     Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study was     to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic,     insulinemic and selected gut hormone responses, appetite, and food intake over two     consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated     in a randomized crossover trial where 42.5g of whole peanuts (P), peanut butter (PB), or no     peanuts (control-C) were added to a 75g available carbohydrate-matched breakfast meal.     Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids     (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive     sensations and food intake were assessed after breakfast treatments and a standard lunch (75g     available carbohydrate).   "
143225|NCT01409694|"     The purpose of this study is to compare the effect after 24 weeks of the oral intake of     vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive     performance in patients suffering from moderate Alzheimer's disease or related disorders     (ADRD) and receiving memantine.   "
142940|NCT01413438|"     Background:      - Glioblastoma (GBM) is the most common malignant brain tumor in adults. Patients with GBM     are usually treated with surgery, radiation, and chemotherapy. Despite this treatment, most     GBMs start growing again. Bevacizumab, a chemotherapy drug, has shown promise in slowing the     growth of GBMs. More research is needed to find out whether having surgery before starting     bevacizumab is more effective than bevacizumab alone.      Objectives:      - To compare surgery plus bevacizumab to bevacizumab alone in adults with glioblastoma.      Eligibility:      - Individuals at least 18 years old whose glioblastoma has come back after treatment.      Design:        -  All participants will be screened with a physical exam, medical history, blood tests,          and imaging studies.        -  Participants will be divided into two groups. One group will have surgery followed by          bevacizumab. The other group will have the drug without surgery.        -  The first group will have surgery as soon as possible and will begin bevacizumab 4 weeks          after surgery. The second group will start the drug as soon as possible.        -  Both groups will receive the drug as an infusion every 2 weeks. They will be monitored          with frequent blood tests and imaging studies. The infusions will continue for as long          as the drug is effective at preventing tumor regrowth.        -  Participants will be contacted every 4 weeks after they stop taking bevacizumab. They          will answer followup questions either in person or by telephone.   "
142941|NCT01413425|"     Background:      - Smith-Lemli-Opitz syndrome (SLOS) is a genetic disorder that prevents the body from making     enough cholesterol. People who have SLOS often need to take extra cholesterol, either in food     or in supplements, for their bodies to work properly. Cholesterol is very important for the     brain and nervous system. Therefore SLOS is highly related to autism, mental retardation, and     other brain and nervous system disorders. Not much is known about how people with SLOS handle     cholesterol and how taking extra cholesterol helps them. A long-term study of people with     SLOS will help answer these and other questions.      Objectives:      - To study the effects of a high-cholesterol diet on people with Smith-Lemli-Opitz syndrome.      Eligibility:      - Individuals of any age who have Smith-Lemli-Opitz syndrome.      Design:        -  Participants will have study visits up to two times in the first year and once a year          every year after that. Each visit will last between 3 and 5 days.        -  Participants will be screened with a physical exam, medical history, and blood and urine          tests.        -  Participants will provide regular blood, urine, stool, saliva, and skin cell samples for          testing.        -  Participants will keep track of the foods they eat at home. During the study, they will          eat a high-cholesterol diet at all times, except for the second study visit (3 to 6          months after the screening visit). That visit will involve a cholesterol-free diet for 4          weeks.        -  Participants will have special cholesterol tests with blood samples at different times          during the study.        -  At different study visits, participants will have tests of mental and physical skills          (including tests for autism). They will answer questions about their diet and food          habits. They will also have hearing and eye tests, body and bone measurements, and          imaging studies. Not all of the tests will be done at every study.        -  Participants will be allowed to leave the study at any time.   "
142942|NCT01413412|"     This is a prospective randomized study to compare surgical methods for the repair of large     abdominal hernia.   "
142943|NCT01413399|"     The objective of this study will be to assess the frequency of return of spontaneous     circulation (ROSC), survival to admission, survival to discharge from the hospital, and     neurologic function at time of discharge from the hospital among patients experiencing out of     hospital cardiac arrest randomized to receive either intra-arrest induction of therapeutic     hypothermia (IATH) or post-arrest therapeutic hypothermia (TH).      Specific aims        1. Develop and test methodologies for randomizing out-of-hospital cardiac arrest (OOHCA)          patients to receive one of two therapeutic hypothermia treatments in the prehospital          environment.        2. Randomize patients experiencing OOHCA to receive either IATH or post-arrest TH and          assess the frequency of ROSC, survival to admission, survival to discharge, and          neurologic function.        3. Estimate the most efficacious volume of chilled saline administered during the intra          arrest period.        4. Identify barriers and strategies for the successful implementation of this project as a          multicenter randomized trial.   "
142944|NCT01413386|"     Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent     in their patency rate and safety at the 6 months after stenting.   "
142949|NCT01413321|"     Hemiparetic gait following acquired brain injury (ABI) is grossly characterized by decreased     speed of walking, increased stance time on the unaffected side, and decreased stance time on     the affected side.These abnormalities are associated with a complex pattern of dysfunction     including muscle weakness, spasticity, impaired sensory-motor control, long-term mechanical     changes in muscles and joints, and cognitive impairments e.g. attention.\ At this stage of     our knowledge it is still unclear which kinetic and kinematic parameters of hemiparetic gait     provide insight about the different components of the complex pattern of dysfunction.      A novel technique had been introduced in the Motion Laboratory of the Sheba Medical Center     consisting of an ordinary treadmill that is equipped with a 'mat' of more than 5000     high-quality capacitive pressure/force sensors. This treadmill developed by ZEBRIS enables     to analyze gait and roll-off patterns on the treadmill.      Aims of the study:        1. To assess variability of data derived from the Zebris treadmill.        2. To investigate stability of hemiparetic gait.        3. To evaluate variability and relevant gait parameters taking place during recovery after          acute ABI.        4. To compare gait on ground with gait on treadmill.      Rationale of the study- Basic assumptions of the study:        1. No significant change in gait parameters is expected in both groups including healthy          controls and chronic ABI subjects in recurrent examination within one week period.        2. Subacute ABI patients are found to be within the context of neurorehabilitative recovery          due to brain plasticity. Therefore a change in gait parameters is expected within two          consecutive examinations in the chosen time intervals.        3. All measurements are subject to error which contributes to the variance of outcomes.      On the grounds of these assumptions:      A. Two consecutive examinations in both groups including healthy controls and chronic ABI     subjects are intended to estimate the error in measured values.      B. Two consecutive examinations in the subacute ABI patient group are intended to estimate     the contribution of neurorehabilitative recovery due to brain plasticity assessed with this     unique research instrumentation.   "
142950|NCT01413308|"     Developed in the early 1970s, Fontan Operation has provided palliative care for patients with     single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV)     alignment abnormalities double inlet and common inlet ventricles (and rarely, straddling     tricuspid valve), in which there is only one ventricular sinus [1]. Most patients present     with symptoms of congestion , low cardiac output, and deep cyanosis immedietly after birth.     Untreated, these heart anomalies are highly lethal. Neonatal heart transplantation is     implacable because of shortage of donors. Fontan operation is a three staged palliative     procedure: the single ventricle pumping blood to the systemic circulation , while blood flows     laminarly to the lungs through direct anastomosis of the superior and inferior vena cavae     (total cavo pulmonary connections), inevitably by-passing the right heart .      This procedure has been shown to immediately correct the mixed venous blood dysfunction,     providing treatment for the prominent signs of cyanosis.      Along with its beneficial outcomes, Fontan circulation patients have been documented to have     a variety of post-operative late complications. Of most substantial, increased systemic     vascular resistance (mean of 10-15 mmHg higher) [2], systolic dysfunction as a result of     decreased preload and increase afterload [3], and atrial arrhythmias [4].      With the advent of bypassing right-heart circulation with Fontan operation, the pulmonary     vascular bed is exposed to a new atmosphere of blood flow. Instead of physiological pulsatile     flow in normal circulation, the pulmonary vasculature is receiving slow velocity, laminar     flow [5]. Patients post-Fontan operations have been documented to have restrictive-type     pulmonary function, but still yet to be correlated with Fontan circulation or as a possible     result of prior lung tissue injury from the pre/intra-operation high volume blood flow.     Regardless, Fontan patients are described to have decreased pulmonary function.      The purpose of this research effort is to document and analyze the pulmonary function of     those patients post-Fontan operation. It is still unclear as to what the long-term effects of     Fontan operation are towards the pulmonary vascular bed, leaving us questions about the     effects on lung capacities, ventilation-perfusion efficiency, and oxygen saturation.   "
143985|NCT01399749|"     The objective of our study is to compare the safety and effectiveness of the use of     autologous cultured adipose tissue-derived stem cells versus cultured autologous chondrocytes     for the treatment of chondral knee lesions.   "
142951|NCT01413295|"     The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have     increased the mean survival of these patients. This outstanding advance is due to the     extended indications for resection of hepatic metastases and to the use of new     chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal     antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is     curative and the majority of patients are overwhelmed by the illness. The first line of     treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild     type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of     responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells     (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A     randomized phase II trial would be performed, by selecting two groups of patients, one of     them would be treated with the best supportive treatment and the other with DCs plus the best     supportive treatment. The aim of the study would be to analyze the outcome after 4 months of     treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses     would be determined pre and post treatment in lymphocytes stimulated with autologous DCs     pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α,     TGF-β e IL-12, would also be measured.   "
142952|NCT01413282|"     The purpose of this study is to determine whether cardiac CT can improve triage of acute     chest pain patients in the emergency department.   "
142953|NCT01413269|"     Early-stage breast cancer patients treated with breast conservative surgery are enrolled in     this study if they meet defined criteria. Patients are randomized into two groups:     conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is     that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar     efficacy and toxicity.   "
142954|NCT01413256|"     Background:      Respiratory allergic reaction causes great suffering to millions of people worldwide. One of     the most known allergen- is the pollen from vegetation, ragweed. Genus Ambrosia Ambrosia     belonged to the complex ragweed flowers are pollinated by the wind and the plant's male     flowers produce large quantities of small grains of pollen and airborne over long distances     and those causes allergic reactions. The plant blooms between June and October, creating a     second wave after wave of allergy caused by spring blossoms.      This plant originated in North America has invaded many areas in Europe and in recent years,     taking over large areas in Israel, Hula Valley and northern Acre Emek Hefer for a pen and     layers to the south. After ragweed plants are based in particular they spread quickly and     invade agricultural fields and significantly reduce the crop.      High allergenic ragweed is a health hazard to humans. Ragweed plant investigated many aspects     of North America and Europe in recent decades and extensive literature on ambrosia, but this     is the first time ragweed study focuses on Israel.      Working hypothesis and aims:      Goal of this study is to identify the existence and nature of the sensitivity distribution of     ragweed in Israel.      Importance of research:      A. Ragweed allergen testing and comparing the effect of exposure to plants on the sensitivity     of the allergic Israeli patients      B. The inclusion of ragweed allergen in the diagnostic and therapeutic panel   "
142955|NCT01413243|"     Trichuris suis ova (TSO) is a probiotic treatment based on the hygiene hypothesis, that has     proven safe and effective in autoimmune inflammatory bowel disease. Clinical trails indicate     that helminth infections have an immunomodulatory effect in multiple sclerosis as well.     Investigators hypothesize that TSO® 2500 eggs given oral every 2 weeks for 12 months is - due     to its immunomodulatory and antiinflammatory effect - in recurrent remittent multiple     sclerosis and clinically isolated syndrome significantly more effective than an oral placebo     treatment as assed by new T2 lesions in cerebral magnetic resonance imaging and clinical     examination.   "
142957|NCT01413217|"     Which is a better breakfast? Egg or cereal?   "
142959|NCT01413191|"     This phase II trial studies how well giving cixutumumab works in treating patients with     metastatic melanoma of the eye. Monoclonal antibodies, such as cixutumumab, can block tumor     growth in different ways. Some block the ability of tumor cells to grow and spread. Others     find tumor cells and help kill them or carry tumor-killing substances to them.   "
142960|NCT01413178|"     The goal of this clinical research study is to compare Busulfex (busulfan) with or without     Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in     patients who will receive an autologous stem cell transplant. The safety of this combination     therapy will also be studied.      Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may     cause cancer cells to die.   "
142961|NCT01413152|"     The main objective of this one year multidisciplinary research is to estimate the frequency     of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an     undetectable blood viral load (VL) and a detectable VL in semen.      Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments     participating to the research project. To warrant feasibility and diversity of participants     needed, the centers will be located in Paris and nearby suburbs. The study design is based on     one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be     taken in the enrolment centers. Biological and virological analyses will be performed by the     laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological     analyses are planned in a subsequent study. Socio-behavioral data will be collected through a     self-administered questionnaire at day 0 and day 30.      Schedule: Patients' enrolment, collection of biological samples and questionnaires will last     10 months (end of first quarter 2012). Biological and virological analyses will be performed     until the end of the first semester 2012. Quantitative and socio-behavioral data will be     analyzed during the third quarter 2012. Results will be released at the beginning of year     2013.   "
142962|NCT01413139|"     The objective of this clinical investigation is to evaluate puncture site complication rate     as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron     Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal     arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without     the use of a closure device.      The hypothesis is that the primary patency at 12 months is non-inferior to the primary     patency obtained in the Durability study (72.2%).   "
144527|NCT01392677|"     This study intends to compare the efficacy and safety of dapagliflozin versus placebo in     patients with type 2 diabetes who have inadequate glycaemic control on a background     combination of metformin and sulfonylurea.   "
142964|NCT01413113|"     This phase I trial is studying the side effects and best dose of iodine I 131 when given     together with pazopanib hydrochloride in treating patients with recurrent and/or metastatic     thyroid cancer previously treated with iodine I 131 that cannot be removed by surgery.     Radioactive drugs, such as iodine I 131, may carry radiation directly to cancer cells and not     harm normal cells. Pazopanib hydrochloride may stop the growth of tumor cells by blocking     some of the enzymes needed for cell growth. Giving iodine I 131 together with pazopanib     hydrochloride may be an effective treatment for thyroid cancer.   "
142965|NCT01413100|"     This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin     together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil     works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the     patient's blood and stored prior to treatment. To store the stem cells patients are given     colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy (cyclophosphamide) to     help stem cells move from the bone marrow to the blood so they can be collected and stored.     After storage, patients are then given high-dose chemotherapy, cyclophosphamide, and     immunosuppression with anti-thymocyte globulin to suppress the immune system to prepare for     the transplant. The stem cells are then returned to the patient to replace the blood-forming     cells that were destroyed by the chemotherapy and immunosuppression. After the stem cells     have engrafted and have matured enough to support the immune system at approximately 2-3     months, patients are given a medication called mycophenolate mofetil (MMF) or Myfortic. This     medication is given to prevent worsening or reactivation of SSc and is referred to as     maintenance therapy.   "
142966|NCT01413087|"     This is a multicenter, open label, randomized, phase 2b study, designed to evaluate the     safety and efficacy of patients with locally advanced pancreatic adenocarcinoma following     intratumoral administration of BC-819 and intravenously administered gemcitabine.     Intratumoral injections of BC-819 will be performed using endoscopic ultrasound (EUS).      Primary Objective: To assess the effect of intratumoral endoscopic ultrasound injection of     BC-819 administered with intravenous gemcitabine on progression-free survival.      Secondary Objectives: To compare the effects of intratumoral injection of BC-819 administered     in combination with intravenous gemcitabine vs. intravenous gemcitabine alone on:      Overall survival, Response rate, Resectability of the target tumor lesion, Quality of life,     Safety, Serological Tumor Marker: CA 19-9, Duration of response, Failure-free survival   "
142989|NCT01412788|"     Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon     patient's quality of life. Although peri-areolar incision has been widely used in benign     breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary     reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach     in BCS for cancer patients has not been established by randomized, controlled trials.      This trial was design to compare the Safety and aesthetic outcomes of breast conserving     surgery between peri-areolar incision approach and traditional methods.   "
142990|NCT01412775|"     The study will examine the influence of a Cognitive Behavioral Therapy (CBT) short-term group     intervention program on the levels of psychological stress and professional exhaustion     experienced by the nursing staff in a cardiac department.   "
142967|NCT01413074|"     Primary Objective: The primary objective is to prospectively assess and compare survival in     subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or     Hemodialysis (HD) treatment.      Secondary Objectives: The secondary objectives are to prospectively assess and compare the     following parameters in subjects receiving PD or HD treatment:        -  Technique failure        -  Cause of death        -  Comorbidity status at baseline and changes throughout the study        -  Change in residual renal function (RRF)        -  Dialysis adequacy (i.e., Kt/Vurea)        -  Change in blood pressure, hemoglobin, and S-phosphate        -  Change in nutritional status        -  Occurrence of bacterial and other infections        -  Hospitalization, including number, duration, and underlying reason(s)        -  Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP)        -  Quality of life (QOL)      Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious     adverse events (SAEs), including abnormal laboratory test findings with clinical     significance, in subjects receiving PD or HD treatment.   "
142968|NCT01413061|"     The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft     with appropriate rigid internal fixation hardware as an alternative to autograft bone graft     with rigid fixation in subtalar arthrodesis procedures. The primary objective of this     clinical trial is to compare the overall fusion rate of the investigational to the control     treatment. Fusion will be determined by clinical findings, radiographs and computed     tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.   "
142969|NCT01413048|"     The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in     patient with stage 1 to 2 essential hypertension.   "
142970|NCT01413035|"     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells     (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2     diabetes.   "
142971|NCT01413022|"     This phase I trial studies the side effects and optimal dose of PF-04136309 when given with     combination chemotherapy (FOLFIRINOX; 5-fluorouracil, leucovorin, irinotecan, oxaliplatin) in     treating patients with locally advanced or borderline resectable pancreatic cancer. These     patients are not candidates for surgical resection which is the most effective treatment for     pancreatic cancer. Giving PF-04136309 together with FOLFIRINOX may shrink pancreatic tumors     in some patients so that surgery becomes an option   "
142972|NCT01413009|"     The main goal of the proposed Robert Wood Johnson Foundation's Interdisciplinary Nursing     Quality Research Initiative (RWJF INQRI) project is to implement, analyze, and disseminate an     evidence-based, nurse-led, inter-professional, multi-component program focused on improving     the care and outcomes of critically ill adults.   "
142973|NCT01412996|"     This study aimed to compare the short term outcomes between SALC and conventional     laparoscopic cholecystectomy (CLC).   "
142974|NCT01412983|"     The objective of this study is to determine the clinical feasibility and to evaluate the     product performance of investigational contact lenses developed by Bausch + Lomb.   "
142975|NCT01412970|"     The purpose of this study is to evaluate the ability to measure central hemodynamics and     heart-lung interactions non-invasively by electrical impedance tomography and compare it to     clinically established hemodynamic monitoring.   "
142978|NCT01412931|"     Women are being asked to participate in a research study that is looking for new methods to     understand and predict premature birth (birth before 37 weeks of pregnancy—full term     pregnancy is 40 weeks). In this study the investigators will be looking at proteins in     vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new     form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and     stiffness, in order to try to know who will have a preterm birth and who will reach full     term. The investigators will collect the vaginal fluid samples and perform ultrasounds both     in the clinic throughout pregnancy in normal women, and from women admitted to the hospital     because they are in early labor. The investigators will collect the placental tissue after     the baby is born (this is normally discarded). This study will help us to understand the     process of preterm birth and the investigators hope that this will eventually allow us to     develop better methods to treat preterm labor and prevent the birth of premature babies.   "
142979|NCT01412918|"     To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if     there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha     subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not     disturbed by tinnitus.   "
142980|NCT01412905|"     Objective: To test the accuracy of a referral system for diabetic eye disease conducted by a     trained screener using a digital camera, a mobile medical unit and a centralized     image-storing software in underserved, ethnically diverse neighborhoods in San Diego.      Methods and Research Design: Retinal screening exams were offered at 8 community health     centers for 1229 individuals, ages 16-80 years with diabetes throughout San Diego County over     18 months. Images were captured with a special digital camera, securely transferred to a     software system and read independently by a trained technician and retinal specialist. An     analysis was conducted to evaluate who had severe eye disease and how accurate the reading of     the technician were compared to the expert ophthalmologist readings.      The investigators would like to demonstrate that telemedicine retinal screening utilizing a     mobile medical unit with a trained technician in high-risk, ethnically diverse populations     can accurately detect positive and negative disease. This may be a model to increase access     to retinal examination in order to meet current guidelines and can allow more efficient use     of the retinal specialist to evaluate and treat disease leading to a more cost efficient     method of care.   "
142991|NCT01412762|"     The purpose of this study is to learn more about what patients undergoing surgery for thyroid     cancer expect from their surgery. Your input may help us to better prepare and inform     patients about their disease and its treatment.   "
142981|NCT01412892|"     Background:      Patients with the genetic disorder neurofibromatosis Type 1 (NF1) are at increased risk of     developing tumors of the central and peripheral nervous system. These include plexiform     neurofibromas. The conventional treatment of these internal plexiform neurofibromas is     surgery. This surgery can be possible on a single and limited tumor. On the other hand these     tumors are often surgically intractable due to their multiplicity and their infiltrating     characteristics Increased activity of mammalian target of rapamycin(mTOR) protein is seen in     neurofibromas. mTOR inhibitor rapamycin , or its derivatives such as everolimus may slow or     stop tumor growth in patients with NF1.      Objectives:      Primary objectives To determine whether everolimus has an effect on the volume of surgically     intractable and life-threatening internal plexiform neurofibromas in patients with     neurofibromatosis 1.      Secondary objectives To determine whether everolimus has an effect on the number and the     volume of cutaneous neurofibromas; to determine whether everolimus modify the signaling     pathways in cutaneous neurofibromas.      Eligibility:      - Adults with neurofibromatosis type 1 with at least one internal plexiform neurofibroma,     life-threatening or causing significant morbidity through compression of organs. This or     these internal plexiform neurofibroma(s) should be intractable by surgery.      Design:      An open-label, single arm, non-randomized, single stage phase IIa study. Baseline phase:     Baseline evaluations will be performed within 2 weeks, and up to a maximum of 4 weeks for     specific exams, before the first dose of study drug.      Treatment phase/duration of treatment: All patients will be treated with RAD001 10 mg p.o     daily dose for one year except in case of unacceptable toxicity, death, or discontinuation     from the study for any other reason.      Follow-up phase: All patients will have two follow-up visits scheduled at 18 and 24 months     after the first dose of the study drug to follow for adverse events (AEs) and serious adverse     events (SAEs) that may have occurred after discontinuation from the study and for internal     plexiform neurofibromas assessment.      Radiological review: All Magnetic Resonance Imaging (MRIs) obtained at baseline, during the     treatment period and the follow-up period will be reviewed by the Neuroradiologist of the     study.   "
142982|NCT01412879|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.     Others interfere with the ability of cancer cells to grow and spread. Drugs used in     chemotherapy also work in different ways to kill more cancer cells or stop them from growing.     It is not yet known whether rituximab is more effective with combination chemotherapy or     bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing     peripheral blood stem cell transplantation.      PURPOSE: This randomized phase II trial studies how well giving rituximab together with     combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy     and peripheral blood stem cell transplantation works in treating older patients with     previously untreated mantle cell lymphoma.   "
142983|NCT01412866|"     Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood     disorders) smoke cigarettes, and most suffer related health consequences. Although combined     treatment with medication and psychosocial therapy can help people with SMI to quit smoking,     it is rarely used. Motivational interventions can enhance the use of combined treatment, but     motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and     Thresholds investigators have developed an easy-to-use, web-based electronic decision support     system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has     demonstrated excellent usability and increased engagement in smoking cessation treatments.      One critical issue is the use of personalized health feedback. Motivational interventions for     smoking cessation for smokers with SMI, including our EDSS, have included personal feedback     from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke.     Feedback regarding carbon monoxide is thought to motivate the user by personalizing the     health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to     implement, and largely unavailable in public mental health and primary care clinics. Further,     research on use of carbon monoxide monitoring in the general population is equivocal. Another     motivational strategy to personalize the negative health effects of smoking is a health     checklist with feedback. Health checklists have been shown to be effective, are easy to use,     have no expense, but have not been assessed separately from carbon monoxide monitor feedback     among SMI smokers. Testing the effect of feedback from the health checklist compared to     feedback from the carbon monoxide monitor is an essential next step in the development of     this tool.      Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess     whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to     higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist     feedback alone.      Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist     feedback leads to higher rates of the distal outcomes, days of smoking abstinence and     Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.   "
143007|NCT01412554|"     The purpose of this study is to identify risk factors for insulin resistance and to     investigate the influence of insulin sensitivity on development of cardiovascular risk     markers like blood pressure, heart rate, body build (weight, BMI, waist-hip ratio, skinfold     thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and     sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20     years.   "
142984|NCT01412853|"     Context:      Prostate cancer is the most common non-cutaneous cancer and the second most common cause of     cancer-related deaths in European and North-American men.      After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is     often fluctuating and PSA nadir may only be reached after 2 years or more and may remain     detectable several years after the completion of radiation. Moreover, PSA bounces and blips     render patients and physicians very anxious about any possibility of a relapse. In this     context, biomarkers that could predict the response to radiation earlier than PSA for     patients with prostate cancer appear long overdue.      Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive     procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines     and Citrate within the prostate gland.      Objectives:      The investigators are conducting a French prospective study on the Evaluation of the Response     to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of     radiation with 3D MR Spectroscopy during the first year after completion of radiation and its     impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not     there could be a correlation between the time course of PSA and that of Choline and Citrate.   "
142985|NCT01412840|"     Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard     treatment to yield maximal pain relief, a period during which the patient suffers severe to     intolerable pain. It would thus be valuable to further evaluate sterile water injection as a     method for achieving rapid relief for this type of pain.   "
142986|NCT01412827|"     There has been a shortage of nuclear isotopes, not only in Canada but around the world. New,     more sensitive SPECT cameras can obtain better images in shorter scan times. These cameras     have also shown the ability to use a smaller dose of radioisotope to obtain the images. New     software has been tested on the standard camera, the GE Infinia-Hawkeye SPECT/CT. The     Diagnostic Imaging Department of The University of Ottawa Heart Institute has also acquired a     new camera, the Discovery NM530c CZT and has been doing heart scans in shorter times. The     investigators will now be looking at the quality of images using less isotope during SPECT     myocardial perfusion imaging for diagnostic and prognostic purposes.   "
142987|NCT01412814|"     This study aimed to discover the biomechanics of gait pattern adaptation in patients after a     total knee replacement.      The first hypothesis of the project was that center-of-pressure manipulation at the foot     during dynamic loading is capable of changing the forces, torques and muscle activation     patterns of the lower limb.      The second hypothesis of the project was that patient-specific center-of-pressure     manipulation at the foot combined with repetitive perturbation training over time will     improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain,     quality of life and energy consumption in patients after a total knee replacement.   "
142988|NCT01412801|"     The study compared the magnitude of the antibody response and safety of a GBS Trivalent     Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the     study investigated the maternal to fetal transfer of antibodies induced by the     investigational vaccine.   "
142992|NCT01412749|"     The goal of this data review research study is to create a registry database using     information (data) collected from patients who have had Endoscopic Head and Neck Surgery     (eHNS). Researchers want to use the registry database to learn more about short-term and     long-term outcomes for patients who have eHNS.      1.1 Primary Objective: To develop a registry database of patients who have had eHNS.      1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional outcomes,     operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center (MDACC).      1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and     distant failure and survival following eHNS.   "
142993|NCT01412736|"     This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the     effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma     exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.   "
142994|NCT01412723|"     Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and     the leading cause of anemia in the world; this can occur at any age, but preschool children     are at particular risk of developing it. This condition may cause serious repercussions for     life, being a public health threat of considerable importance worldwide.      Food fortification is considered the most effective solution to counter this situation,     because it can help more people than other solutions. It is going to carry out a community     trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a     dietary supplement in preschool children of Medellin with depleted levels of iron; in terms     of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized     that at the end of the study the effect of milk fortified with iron amino acid chelate won't     be less than the effect of fortified with ferrous sulfate.      It is hoped that the results may contribute, albeit indirectly, to improve the health status     of children with depleted levels of iron whom consume iron-fortified products.   "
142995|NCT01412710|"     The purpose of the present pilot study is to determine the effect of vitamin D     supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk     and in improving blood glucose control in type 2 Diabetes subjects . The investigators are     working with Hispanics and African Americans living in Miami, Florida.   "
142996|NCT01412697|"     The investigators implemented a theory-based randomized controlled trial in ten rural     Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including     fruit/vegetable intake as a primary outcome. Schools were randomized to intervention or     control groups. Goal setting, peer leaders, and in-class workshops were intervention     features. Seventh graders filled out surveys on health behaviors, psycho-social variables,     and demographic characteristics. The investigators expected schools receiving the     intervention to report a higher fruit-vegetable intake compared to control schools where     students received standard health information. Sample (n=1,119) was 48.5% female, 50% White,     with a mean age of 12.6 years. Fruit/vegetable intake was significantly higher in     intervention schools at immediate post and at 1-year follow-up compared to controls.   "
143008|NCT01412541|"     The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of     the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal     angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.   "
142997|NCT01412684|"     Most resectable tumors arising in the body or tail of the pancreas are malignancies or     premalignancies which are surgically treated with distal pancreatectomy in combination with     splenectomy. Retrieval of the lymph node tissue which lies along the splenic vessels is     necessary to complete an oncologically sound operation. Two techniques for spleen preserving     distal pancreatectomy have been described, but only a small number of lesions are amenable to     spleen preserving pancreas surgery because these operation compromise oncologic principles.     Removal of a normal spleen usually does not cause immediate consequences but can make     patients vulnerable to life threatening infections. Asplenic patients must be vigilant for     these infections and antibiotic prophylaxis is recommended anytime a fever occurs.     Splenectomy results in measurable changes in the cellular components of the blood. If     thrombocytosis occurs as a result of splenectomy, it requires life-long antiplatelet     treatment.      Some childhood hematologic disorders such as hereditary spherocytosis are successfully     treated with partial splenectomy. The post-surgical remnant spleen has been shown to be     viable and functional. Both hematologic and immunologic function of the spleen seems to be     preserved in most patients. Partial splenectomy has also been successful ly employed to treat     benign and malignant lesions of the spleen. Unfortunately these indications for surgery are     rare and so the experience with partial splenectomy is small.      To date, distal pancreatectomy with partial splenectomy has not been described in the medical     literature. The investigators have devised a surgical procedure combining distal     pancreatectomy with partial splenectomy, in principal allowing preservation of splenic     function without compromise of oncologic principles. This procedure is possible now because     of new technology which allows for near bloodless transection of solid organs. These     instruments are routinely used in liver, kidney and pancreas surgery. There are scattered     reports of successful use of these instruments in splenic transection, but there is no large     experience to date.      The study intends to answer the question, is the proposed procedure, distal pancreatectomy     and partial splenectomy, a viable alternative to the current standard of care, distal     pancreatectomy with total splenectomy, for patients who will undergo surgical treatment of     pancreas lesions arising in the body or tail of the pancreas?   "
142998|NCT01412671|"     This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal     cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational     study for patients with unresectable or advanced RCC under real-life practice conditions. The     objective of this study is to assess safety and effectiveness of Nexavar at some limited     sites which joined to clinical trial of Nexavar, before available of it in the market. The     enrollment period is 2 months, and patients who received Nexavar will be recruited and     followed one year since starting Nexavar administration. The data of this study will be     integrated into the Nexavar PMS and the data will not be analyzed and reported alone.   "
142999|NCT01412658|"     Background: A novel milk peptide has been shown in laboratory setting to have natural     anti-cancer properties and extend lifespan and improve metabolism in animal models. The     purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine     whether this novel milk peptide positively influence blood markers, metabolism and improve     quality of life.   "
143000|NCT01412645|"     The aim of this study is to investigate potential metabolic effects of resveratrol in men     with metabolic syndrome(otherwise healthy).      The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will     increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate     bone-turnover.   "
143001|NCT01412632|"     The primary endpoint is to investigate the difference in pain between patients who receive     deep sedation with spontaneous breathing versus patients who receive general anesthesia.   "
143002|NCT01412619|"     Patients after cardiac surgical operations often exhibit neuropsychological complications. In     particular, the post-operative delirium is associated with a significantly increased     morbidity and mortality.      Intracerebral microembolization in addition to inadequate cerebral perfusion during surgery     was verified as the main cause of this.      The aim of the study is to demonstrate a correlation between intraoperative low measured     cerebral oxygen levels and a loss neurological outcome, especially the development of     postoperative delirium, using non-invasive cerebral oximetry (RSO2).   "
143004|NCT01412593|"     Liver disease is a common medical problem in Saudi Arabia. Early studies indicated that     around 10% of the Saudi population is either infected with hepatitis B or C. An estimated 12%     of chronic HCV and HBV patients undergoing liver biopsy from Saudi centers have cirrhosis. Of     these 3-5% would decompensate yearly thereby requiring liver transplantation. Based on the     most recent national census figures, and a 1-2% prevalence rate of HBV and HCV nationwide, an     estimated 1,000 patients would require liver transplantation on a yearly basis for     decompensated cirrhosis.      Liver transplantation is the only available life saving treatment for patients with end stage     liver disease. Unfortunately less than 100 liver transplantations are performed in Saudi     Arabia in three centers. Around 100 other patients travel abroad for transplantation annually     while all other patients progressively deteriorate and eventually die from the complications     of decompensated liver cirrhosis.      In addition, even in patients who are listed for liver transplantation, often patients are     too sick to wait on the transplant list that often takes more than a year and the on-list     mortality is high. A procedure or an intervention that may help to stabilize liver function     in order to help patients survive on the transplant list while awaiting liver transplantation     would be of immense benefit. Examples of such interventions are already approved and used in     some centers like the MARS system.   "
143005|NCT01412580|"     Because of the high returns of schooling in developing countries, policymakers pay a lot of     attention to increasing school access. But if the mother is deficient in key micronutrients,     brain development can biologically constrain children's demand for education. To execute this     strategy, the investigators collect cohort observational data on a previous randomized     controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar     es Salaam, Tanzania, between 2001 to 2003.   "
143006|NCT01412567|"     Prevention of perinatal transmission is essential to decrease the global burden of chronic     HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to     the newborns of HBsAg positive mothers is the standard of care for prevention of HBV in     babies. Some studies have however, shown that vaccine alone may be equally effective. Hence,     immunoprophylaxis with hepatitis B vaccine with or without HBIG is effective in prevention of     transmission of overt HBV infection to the babies. The primary outcome measure of most of the     trials on immunoprophylaxis was the occurrence of hepatitis B, defined as a blood specimen     positive for hepatitis B surface antigen (HBsAg). However, whether this immunoprophylaxis     also prevents HBsAg negative HBV infection (occult HBV infection) in babies is not known. In     the present study the investigators evaluated the efficacy of the two regimens; vaccination     alone and compared it with vaccination plus HBIG administration at birth in preventing     transmission of both overt and occult HBV infection to the newborn babies.   "
143021|NCT01412372|"     The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in     patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will     evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma     cytokines before and after treatment with Lialda.   "
143009|NCT01412528|"     Today a variety of diagnostic tools to detect allergenic agents are available such as skin     tests, provocation tests and blood tests. Due to its high sensitivity and low costs the skin     prick test is the most commonly used test to identify allergies in patients. By using this     kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin     prick test a cheap, easy-to-handle and rapid diagnostic tool. However, as research proceeds,     new tools appear with the intention to make future applications even more convenient -for     both, the patient and the physician. For that purpose the development of the so called     Easyprick Allergen Test System is under way, consisting of a foil that carries     ready-to-use, allergen-soaked sponges which can easily be applied to the skin after pricking.      Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic     and non-allergenic components. In order to control variability and to achieve consistency and     reproducibility for optimal safety and sensitivity/specificity, it is essential to     standardize the amount of allergen used in prick tests. The present study aims to standardize     eight allergen extracts by using this method. Standardized extracts will then be applied in     the Easyprick Allergen Test System which will be evaluated and compared to the conventional     prick test in a second study.        -  Trial with medicinal product   "
143010|NCT01412515|"     Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8     (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR     inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to     evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients     suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion,     all patients will have at least 10 lesions or more than one limb or 3% of body surface     affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective     response to everolimus after 6 months therapy (complete or partial response per ACTG     criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a     response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%.     Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3     patients responded, 15 patients will be accrued in a second stage.   "
143011|NCT01412502|"     This study concerns the nearest relatives of patients who have passed away within 3 days of     admission to an ICU due to: (1) brain death with multiple organ donation +/- tissues or (2)     death via limitation and / or cessation of active treatment (LATA) without brain death or (3)     sudden death of a previously healthy patient (no physical or mental limitations; MacCabe     score = 0) within 3 days of admission to ICU without LATA nor brain death. Our primary     objective is to determine the proportion of nearest relatives at risk for post traumatic     stress disorder as defined by an Impact of Event Scale score greater than 37, and to compare     this factor between the three above-mentioned groups.   "
143012|NCT01412489|"     The purpose of this study is to evaluate the intrauterine adhesion rate after the application     of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were     tolerance and side effect and subsequent fertility.   "
143013|NCT01412476|"     Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. However, the     relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the prevention     of the risk of MS are still inconsistent. The purposes of this study are going to investigate     the relation of coenzyme Q10, antioxidant vitamins concentration with the blood lipid levels,     the markers of lipid peroxidation (TBARS), antioxidant enzymes activities (catalase,     glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-CRP,IL-6     and adiponectin). The investigators will recruit MS patients (case group, n = 100) and     age-gender matched healthy subjects from previous study(n = 105) as a control group . The     inclusion criteria of MS are according to the Bureau of Health Promotion, Department of     Health in Taiwan (2007).Hopefully, the results of this study could provide the information to     what has been know in MS subjects. The investigators expect coenzyme Q10 or antioxidant     vitamins could be a preventive supplement to reduce the risk of MS.   "
143014|NCT01412463|"     The objective of this study is to evaluate the immediate and long-term (up to 12 months)     safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the     treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal     artery) between 40 mm and 180 mm in length.   "
143015|NCT01412450|"     This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in     patients presenting with a narrowing or blocking at the level of the knee artery, which leads     to a limited walking distance, rest pain or non-healing ulcers.   "
143016|NCT01412437|"     The investigators will use different types of brain imaging (MRI) in patients with     Phenylketonuria (PKU) who are currently not on a strict diet to test the hypothesis that     there is improvement in brain circuitry and biochemistry after return to diet and/or     sapropterin dihydrochloride (Kuvan).   "
143017|NCT01412424|"     MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical     product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety     of MYCAPSSA™ treatment in patients with acromegaly.   "
143018|NCT01412411|"     The purpose of this study has been to understand the prevalence of under nutrition and     develop effective interventions for improving growth and micronutrient status of infants     receiving complementary foods.      In this community based randomized clinical trial, the nutrition education package     implemented aimed to improve hematological parameters including the micronutrient status and     to see effect on growth indicators.   "
143019|NCT01412398|"     This study is a regulatory post marketing surveillance in Japan, and it is a local     prospective and observational study of patients in continuous cyclic peritoneal dialysis     (CCPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to     assess safety and efficacy of using Fosrenol in clinical practice. This study is also all     case investigation of which the enrollment period is one year, and all patients in CCPD who     received Fosrenol for hyperphosphatemia will be recruited and followed one year.   "
143020|NCT01412385|"     The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for     patients with primary immunodeficiency (PID) diseases.   "
144528|NCT01392664|"     Women who had urinary stress incontinence and underwent one of two procedures: the classic     TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.   "
143022|NCT01412359|"     The overall purpose of this study is to determine if replacing standard soybean oil based fat     emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the     progression of parenteral nutrition associated cholestasis. It is a compassionate use     protocol for patients who already have significant cholestasis related to parenteral     nutrition.   "
143023|NCT01412346|"     The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based     foods and fish on indicators of cardiovascular disease risk at two different levels of salt     intake.      The study is a 20-wk randomized controlled crossover trial. The subjects follow a     salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all     subjects. After that the subjects are randomly allocated to one of two groups. Group 1     consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16     weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups     receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).   "
143024|NCT01412333|"     This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy     and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with     relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab     600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the     first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,     with placebo injections matching interferon beta-1a SC three times per week; or interferon     beta-1a 44 mcg SC injections three times per week (with placebo infusions matching     ocrelizumab infusions every 24 weeks).   "
143025|NCT01412320|"     Purpose of the study is to characterize the potential acute and long-term improvement of     dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).      Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a     double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial     effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day     long-term, double blind, placebo-controlled parallel study the chronic effects of dietary     flavanols on vascular function in 52 patients with ESRD will be evaluated.   "
143052|NCT01411943|"     This study examines the relationship among epigenetic alterations and the development and     persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms,     anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early     stage breast cancer. The relationship among inflammatory markers and psychoneurologic     symptoms will also be explored. It is hypothesized:        1. Chemotherapy triggers inflammatory activation, which in turn leads to the acquisition of          genetic alterations. These alterations result in cellular changes and are modified over          time.        2. Inflammatory activation and epigenetic alterations are related to the temporal          development, severity, and persistence of psychoneurologic symptoms.   "
143026|NCT01412307|"     Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation     failure represents a typical unmet medical need prompting active development and validation     of new agents and treatment strategies. The LEBEN protocol combines two agents, lenalidomide     and bendamustine, framing different targets on both tumor and microenvironmental cells of HL.     These agents, while showing a low risk of overlapping extrahematologic toxicities, may hit     the proliferation machinery of H-RS cells and/or their progenitors, synergistically inhibit     tumor-related angiogenesis and interfere on cytokine-mediate circuitries operating in the     microenvironment to support tumor cell survival.      A weekly schedule of bendamustine, at 60 mg/m2, is combined with the continuous     administration of increasing dose of lenalidomide (10, 15, 20 e 25 mg dose levels in a 28-day     cycle). Such schedule of Bendamustine is aimed at enhancing the antiangiogenic and     immunomodulatory activity of continuous Lenalidomide, as studies have shown that low and     protracted doses of alkylators induce a decrease in microvascular density of tumor tissues     and inhibit mobilization and viability of circulating endothelial progenitors.      The Bayesian phase 1/2 dose finding method of Thall and Cook was employed. This method     chooses doses based-on both response and toxicity, and accounts for the trade-off between     these two outcomes.   "
143027|NCT01412294|"     The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for     gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.   "
143028|NCT01412281|"     The purpose of this study is to assess the humoral immune response and safety of the     parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V     using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly     adults, using the EMA (European Medicines Agency) regulation as a guideline.   "
143029|NCT01412268|"     1. Obesity is a big health problem worldwide.        2. Mostly obese people have food addiction and bad eating habits.        3. Bariatric surgery is a good alternative for patients who failed to loose weight with          other measures like behavioral changes, activities and sports, diet, etc..        4. The investigators know the changes occurred after surgery in eating habits due to          restrictive and malabsorptive feature of the surgery performed.        5. There is no study in the literature to measure these changes.        6. The investigators will try to detect these kind of behavioral changes by a survey before          and after surgery.   "
143030|NCT01412242|"     Prospective cohort study aimed at simplifying the diagnostic approach to symptomatic patients     with the clinical suspicion of deep vein thrombosis (DVT) of the lower extremities. All     patients will receive a pre-test clinical probability (PTP) and the determination of D-dimer.     Patients with low PTP and negative D-dimer will have the diagnosis ruled out. All other     patients will undergo compression ultrasonography (CUS) of the proximal vein system. Patients     with negative CUS and either low PTP or negative D-dimer will have the diagnosis ruled out,     while those with high PTP and positive D-dimer will undergo extensive ultrasound     investigation of the calf vein system. All patients in whom the diagnosis of DVT is ruled out     will be followed-up prospectively up to three months for documenting the development of     symptomatic thromboembolic events.   "
143031|NCT01412229|"     This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head     and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged     appropriate for non-surgical definitive therapy.   "
144578|NCT01391988|"     Prospective trial comparing post-operative complications and seroma formation after     mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic     scalpel.   "
143033|NCT01412203|"     Childhood obesity is a major public health threat. Physical activity and healthy eating     contribute to the maintenance of healthy weights. Individually oriented behaviour change     programs may not be able to overcome the influence of what has been called an obesogenic     environment. Action Schools! BC (AS! BC) used a socio-ecological approach to enhance     opportunities for physical activity and healthy eating in elementary schools and created     systemic change at the provincial level. AS! BC helps elementary schools customize action     plans, based upon their local context, to contribute to the health and well-being of children     and the school community. Pilot research showed that AS! BC was an effective and feasible     model. The provincial dissemination of AS! BC has been launched and partners from across many     sectors are involved to enhance the sharing of knowledge and increase the implementation of     the AS! BC model across British Columbia. The dissemination provides an unprecedented     opportunity for evaluating how changing the school environment can promoted healthy weights     in children. The dissemination was evaluated using a cluster randomized design; 30 elementary     schools (n = 1529 consented children) from four (out of five) provincial health authorities     volunteered to participate.      The primary goals of the research are:        1. to determine if the Action Schools! BC (AS! BC) model is an effective approach to          positively change school environments and health related behaviours of children from          diverse geographical regions and cultural groups, and        2. to determine if the supports provided to schools or the community context influence the          uptake and use of the AS! BC model.      This research will contribute to the science of obesity prevention and knowledge use as well     as public health practice.   "
143034|NCT01412190|"     The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White     administered with an injector device on aged skin in the face, hands and décolletage.   "
143035|NCT01412177|"     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of     Meniere's disease.   "
143036|NCT01412164|"     The study aims to further assess the safety, efficacy and the performance of its delivery     system of FIREHAWK rapamycin-eluting stent up to five years.   "
143037|NCT01412151|"     The purpose of this study is to extend findings from the creatine dose-finding study     (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and     clinical impact of high dose creatine.   "
143038|NCT01412138|"     Human endometrium is a very dynamic tissue characterized by cyclical process of     proliferation, differentiation and cellular shedding as part of each menstrual cycle. This     issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence     of endometrium outside the uterine cavity. The existence of a somatic stem cell population in     endometrium could explain the incorrect proliferation of these cells, which would lead to     formation of endometriotic foci.   "
143039|NCT01412125|"     Huntington's disease (HD) is a rare, autosomal dominant, progressive neurodegenerative     disorder typically becoming noticeable in middle age. It is clinically characterized by     progressive involuntary movements (bradykinesia and hyperkinesia), neuropsychiatric     disturbances (depression, irritability), and cognitive impairments progressing to dementia.      The striatum (caudate and putamen) is the primary area of neuronal degeneration in HD. Today,     there is no validated curative treatment. HD affects approximately 6 000 patients in France     and more than 30 000 individuals are considered at risk for this disease.      While the disease gene is discovered and we are capable to do a predictive genetic diagnosis     for asymptomatic patients, there is no clinical or biological way to predict the age of onset     or the progressive profile of patients.      One of the fundamental characteristics of this disease is its extreme variability from one     patient to other both in terms of their evolution and their onset of action. Thus, this     inter-individual variability severely limits the genetic counselling and complicating the     neurological assessment.      Increasingly, it has been assumed that modifier genes may be the source of this     inter-individual variability and that their identification could help the understanding and     prediction of disease progression.      Given that the mutant protein is ubiquitous, the molecular dysfunction of neurons could be     found in peripheral cells from the bloodstream and will be more accessible to investigation.   "
143040|NCT01412099|"     The purpose of this research study is to evaluate the effectiveness of two methods of     delivering information about nutrition and physical activity to non-traditional college     students. Participants will receive either a printed feedback report alone, or the feedback     report in addition to a series of phone calls from a peer counselor. The peer counselors will     provide nutrition and physical activity counseling using motivational interviewing     techniques. Nutrition and physical activity outcomes will be measured for both groups and     compared.   "
143041|NCT01412086|"     This study evaluated the inter- and intra-rater reliability of the GEBA Scale with     photonumeric guide for the assessment of overall eyebrow fullness. There is no treatment     (intervention) associated with this study.   "
143042|NCT01412073|"     trial of 3 protocols to determine the best one to control blood loss during caesarean section   "
143043|NCT01412060|"     The objective of this study is to evaluate the efficacy and safety of cariprazine relative to     placebo in the prevention of relapse of symptoms in patients with schizophrenia.   "
143044|NCT01412047|"     How does long term treatment with Soliris affect HAHA in PNH patients?   "
143045|NCT01412034|"     The available medications used to treat HoFH are targeted at reducing circulating levels of     total and LDL-cholesterol. These measures can retard the progression of cardiovascular     disease, however, they are unlikely to regress existing disease due to years of cholesterol     accumulation in the vessel walls and therefore cannot adequately reduce the existing risk for     an ischemic event. HDL has multiple actions that could lead to plaque stabilization and     regression, such as rapid removal of large quantities of cholesterol from the vasculature,     improvement in endothelial function, protection against oxidative damage and reduction in     inflammation. This study will assess the effects of CER-001, a recombinant human Apo-A-1     based HDL mimetic, on indices of atherosclerotic plaque progression and regression as     assessed by 3Tesla MRI measurements in patients with HoFH.   "
143307|NCT01408615|"     This observational study will examine the safety and efficacy profile of Elonva     (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian     stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for     the development of multiple follicles in an assisted reproductive technology (ART) program.   "
143046|NCT01412021|"     This study of Humira will be conducted to clarify the following with regard to the treatment     of juvenile idiopathic arthritis affecting multiple joints with this drug:        -  Unknown adverse drug reactions (especially important adverse drug reactions)        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting        -  Factors that may affect the safety and effectiveness of Humira   "
143047|NCT01412008|"     Since the use of botulinum toxin in treating spasticity has already been proven effective, we     are now using magnetic resonance imaging to examine the toxin diffusion within muscle (post     injection) in order to determine the specific toxin dose required for an optimal treatment     response.   "
143048|NCT01411995|"     The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain     associated with intrauterine device (IUD) insertion. They will be randomized to either     placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically     via angio-catheter just before IUD insertion. Anticipated pain scores will be assessed using     a visual analog scale prior to insertion. Using the same pain scale, patients will again be     asked at the end of the procedure to rate their pain.   "
143049|NCT01411982|"     This study will identify the role of PACAP (pituitary adenylate cyclase-activating     polypeptide) deficiency in patients with nephrotic syndrome. PACAP is a neuropeptide that has     a putative role as an inhibitor of megakaryopoiesis and platelet function. Patients with     nephrotic syndrome show decreased PACAP plasma levels, due to urinary loss. We hypothesize     that in severe nephrotic syndrome, plasma deficiency of PACAP enhances megakaryopoiesis and     causes blood platelet activation, which contribute to the increased rate of thromboembolic     disease in these patients.      To test our hypothesis, the role of PACAP deficiency on pro-thrombotic state in patients with     nephrotic syndrome will be studied using patient blood and urine samples.   "
143050|NCT01411969|"     The aim of this study is to present new data for a better understanding of the anatomic     correlation of these two notches.      This study included 32 nasal cavities (16 individuals) with external nasal dilator strip     (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol     spray);   "
143051|NCT01411956|"     Researchers have linked media messages such as television programs to multiple problematic     health behaviors. The narrative style of many television programs—involving a plot, recurrent     characters, entertaining situations, and familiar settings—makes them compelling and likely     contributes to the powerful influence these programs can have on behavior. However, narrative     messages are not frequently utilized for prosocial purposes. In particular, health education     embedded in a narrative context has been neither commonly utilized nor carefully evaluated.     Using constructs from two complementary theories of health behavior, family physicians in a     large metropolitan region have developed a situation comedy entitled White Coats that aims     to provide quality patient education. The program currently airs on a local public access     channel. The objective of this project is to evaluate the effect of one particular episode of     White Coats on patient beliefs regarding hypertension.   "
143053|NCT01411930|"     Antipsychotic medicines used to treat mental illnesses have been associated with effects on     blood sugar control. Laboratory studies have shown that certain medications in particular may     alter how insulin works. One purpose of this study is determine if antipsychotic medications     have immediate effects on insulin action in individuals who do not have a mental disorder,     but who have risk factors for diabetes. A second purpose is to demonstrate the feasibility of     using volunteers without psychiatric disorders, and who do not take psychiatric medications,     as a means for studying antipsychotic metabolic effects.   "
143054|NCT01411917|"     Consenting subjects will be randomized to receive injection of bupivacaine or placebo before     surgery for ileostomy takedown (injection administered after general anesthesia has been     administered). Pain and side effects will be assessed periodically after surgery using the     verbal Numeric Rating pain Scores, including at the timepoint of 24 hours after surgery. All     subjects in this study will be given toradol to ensure adequate pain control.   "
143055|NCT01411904|"     The purpose of this study is to determine if the magnetic needle, in combination with     magnetic nanoparticles can accurately identify minimal residual disease in leukemia patients.   "
143056|NCT01411891|"     Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee     arthroplasties (TKA) were performed in the United States which is at a rate of 18.1 per     10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030.     Effective post-operative analgesia is an important component with regards to patient     satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of     surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of     thromboembolic disease in patients undergoing total knee or total hip replacement when     compared with general anesthesia. Post-operatively, regional anesthesia has been shown to     reduce pain scores and/or morphine consumption as well as opioid-related adverse effects.      Epidural catheter or spinal anesthesia has become the standard of care at the University of     Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is still     occasionally used for patients that would strongly prefer a general anesthetic, those that     are taking anticoagulation medications or with a coagulopathy, those with previous back     surgery, and those with certain neurologic conditions such as multiple sclerosis or spina     bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters     (FNC) for postoperative analgesia following TKA show no significant difference in pain     scores, morphine consumption, or post-operative nausea and vomiting. However, epidural     analgesia has been associated with higher incidence of hypotension and urinary retention.     FNC's placed for postoperative pain allow patients to ambulate more effectively as there     should not be much of a lower extremity motor block. Patients with a FNC for postoperative     analgesia also do not require a urinary catheter which eliminates a common source of     infection in postoperative patients. FNCs have also demonstrated improved rehabilitation     times and decreased hospital stays which has led to an increased insertion rate of FNCs for     postoperative analgesia following TKA at the University of Wisconsin.      Pyarthrosis is a fairly common complication occurring at a rate of 2% following primary and     5.6% following revision TKA. Infection can be a devastating complication following     implantation of joint hardware often leading to extended hospitalization/rehabilitation stays     and return trips to the operating room. The average billed charges for all types of revision     TKA procedures was $49,360 with average length of stay of 5.1 days. Indwelling lines are a     known infection risk and indwelling lines in the femoral region are known to be associated     with a high incidence of catheter colonization. At 48 hours, Cuvillon et. al. found that 57%     of FNCs placed without the use of a chlorhexidine impregnated patch had positive bacterial     colonization. They also described three cases of transient bacteremia secondary to FNCs in     the 208 catheters that they analyzed.      Chlorhexidine impregnated patches also known as biopatches have been shown to reduce the     incidence of bacterial colonization and infection of various indwelling lines including     epidurals and central venous catheters. Currently no standard of care exists that requires     the use of biopatches for FNCs. The investigators propose studying the use of the biopatch to     reduce the incidence of bacterial colonization of femoral nerve catheters.      The investigators will study the efficacy of the biopatch at decreasing the rate of bacterial     colonization of FNCs in TKA patients. The FNCs will be inserted in the standard fashion and     removed at the end of therapy. Typically the FNC infusion will continue until the morning of     post-operation day (POD) #1 or 2. The process for FNC insertion first involves sterile prep     and drape of the femoral region. Full sterile technique will be utilized including gown,     gloves, and mask. Ultrasound guidance is then commonly utilized to identify the femoral     nerve. Following patient sedation and skin infiltration with local anesthetic, a tuohy needle     is inserted adjacent to the femoral nerve. A catheter is then threaded through the needle in     close proximity to the femoral nerve. Patients will be randomized to either no chlorhexidine     impregnated patch or to a chlorhexidine impregnated patch that will be located at the     catheter exit site. On the morning of POD 1 or 2, the FNC infusion will be discontinued.     Typically, Twenty-four to forty-eight hours after catheter insertion, it will be removed in a     sterile fashion and the skin surrounding the catheter exit site will be swabbed and the     distal catheter tip will be sent for culture to determine bacterial colonization. In     addition, the investigators will interview patients and review clinical data to determine     signs of infection and/or catheter tip colonization rates.   "
143057|NCT01411878|"     This study is comparing the impact of two teen pregnancy prevention interventions, Reducing     the Risk and Love Note with a non-related training on community building to determine which     is most effective for which participants in delaying sexual initiation, enhancing use of     condoms and other forms of birth control, decreasing sexually transmitted diseases and     decreasing the number of pregnancies. The participants were 1450 youth between the ages of 14     and 19 including those from poor urban settings, those from immigrant and refugee families     and those from the foster care system. Both girls and boys were be in the study. The     investigators predict that girls, immigrants and refugees and foster youth will have better     outcomes when participating in Love Notes, a program focused on healthy relationship     formation and maintenance as a frame for how to manage the sexual aspect of relationships     while boys and urban youth will have better outcomes when participating in Reducing the Risk.     Both groups will have better outcomes than those in the control condition.   "
143058|NCT01411865|"     Diabetes is a common and serious chronic disease. However, there is a large gap between the     level of care that people should receive (based on research and guidelines) and the level of     care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the     Canadian Diabetes Association has a strategy to improve heart disease screening and treatment     for people with diabetes. This study will evaluate whether the strategy works. The focus of     the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them     delivery better care for their diabetic patients. In Ontario, only half of doctors received     this Toolkit. We will compare the quality of care received by diabetic patients whose doctors     received this Toolkit versus those who doctors did not.   "
143074|NCT01411657|"     Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to     enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in     diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery     to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement     (improve vision indices) in ischemic optic neuropathy. Patients in the trial will receive an     NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to     evaluate safety and efficacy.   "
143059|NCT01411852|"     Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the     early treatment of patients with traumatic shock compared to standard fluid resuscitation.      Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive     resuscitation will result in the same volume of early crystalloid (normal saline) fluid     administration compared to standard crystalloid resuscitation. The null hypothesis regarding     safety is that hypotensive resuscitation will result in the same percent of patients     surviving to 24 hours after 911 call received at dispatch compared to standard fluid     resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival     in the Emergency Department or until hemorrhage control is achieved in the hospital,     whichever occurs earlier.   "
143060|NCT01411839|"     The current HIV treatment adherence project was designed to adapt culturally and then pilot     test an empirically supported cognitive-behavioral therapy program for adherence and symptoms     of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.   "
143061|NCT01411826|"     To evaluate online peer support and colorectal cancer screening behavior among individuals     who are not currently meeting colorectal cancer screening guidelines. This is a randomized     controlled trial.   "
143062|NCT01411813|"     This study examines the role of anxiety in food intake among patients with AN by measuring     caloric intake in a standardized, laboratory meal with alprazolam versus a placebo. Patients     will participate in two test meal sessions, one after receiving alprazolam and one after     receiving a placebo. Patients will be administered psychological measures of anxiety, mood,     and eating behavior. Primary outcomes include caloric intake in a laboratory test meal and     pre-meal anxiety levels.   "
143063|NCT01411800|"     The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and     safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.   "
143064|NCT01411787|"     This is a randomized, single-site pilot study incorporating one control group. This research     involves an exercise group and a non-exercise group (control group).      The patients who are in the exercise group will be enrolled in the Dallas County Women's     Adventure Boot Camp. This will require them to undergo exercise training 3 times per week,     under the direction of an experienced personal trainer in a group setting. All Boot Camp     personal trainers are trained in basic cardiac life support (CPR) and are trained to watch     for any signs or symptoms associated with a poor exercise response.      The investigators hypothesize that randomizing women to a supervised exercise program of core     conditioning, muscular/circuit training, and short distance running administered during     neoadjuvant chemotherapy for breast cancer can be performed.      Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their     breast cancer. This will be about 4 - 6 months.   "
143065|NCT01411774|"     The investigators are conducting a randomized double-blind placebo-controlled study to assess     the efficacy of d-cycloserine augmentation of cognitive-behavioral therapy for the treatment     of pediatric obsessive compulsive disorder. This study represents an innovative approach in     translating bench research findings into clinical research and testing a new approach for     optimizing an effective psychotherapy with a safe non-psychotropic medication.   "
143066|NCT01411761|"     Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are     favorable microorganisms that regulate the flora of the gastrointestinal system. In this     study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and     duration of phototherapy on very low birth weight infants.   "
143067|NCT01411748|"     Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal     system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida     colonization. The objective of this study is to evaluate the efficacy of prophylactic S     boulardii in reducing the candida colonization and infection in very low birth weight     infants.   "
143068|NCT01411735|"     BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure     and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and     therapy.      METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with     controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial     of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen     consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI;     Doppler-echocardiography; and vascular ultrasound.   "
143069|NCT01411722|"     The study aims to assess 1) the electrical activity of the diaphragm in mechanically     ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical     activity of the diaphragm may predict the weaning outcome   "
143070|NCT01411709|"     A pilot investigation into the stress relieving properties of Vitano® which will assess the     following hypotheses      Individuals exposed to Vitano® will demonstrate diminished blood pressure and heart rate     responses to mental stress compared to individuals in the control condition      Physiological recovery (BP, HR and cortisol) from mental stress will be enhanced in     individuals exposed to Vitano® compared to individuals in the control condition      Vitano® will have positive effects on cognitive functioning.      Subjective ratings of stress will be reduced in individuals exposed to Vitano® compared to     individuals in the control condition      There will be a significant improvement in subjective well-being in individuals taking     Vitano®.   "
143071|NCT01411696|"     This is a retrospective data collection study to evaluate the efficacy, safety, and     re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following     informed consent, there were no patient study visits. All data was collected via chart     review.   "
143072|NCT01411683|"     This study aims to compare mandibular overdentures retained either by mini or standard size     implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and     oral health-related quality of life. We will also evaluate post surgical discomfort, the     success rate of prostheses and implants in the long term, denture quality and costs.   "
143073|NCT01411670|"     The purpose of this study is to investigate the effects on systemic hemodynamics,     microcirculation and organ function of human Protein C concentrate in patients with sepsis     and septic shock.   "
143075|NCT01411644|"     This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian     dysfunction (WHO III status).   "
143076|NCT01411631|"     There is some evidence that polyphenols can affect cognitive function. Therefore, consumption     of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive     performance. The objective of this study is to investigate the effect of polyphenol     consumption served in the form of Concord Grape Juice (CGJ) on cognitive performance and     driving performance in Mums.      The study design will be a repeated measures, double-blind, randomised, placebo controlled,     crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will     undergo two 12 week dietary interventions which will entail daily consumption of a 12oz     serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period     between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive     performance and driving performance will be assessed (using the driving simulator at the     Institute for Transport Studies). CGJ is a common ingredient in commercially available     products.      Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged     40-50. This population generally have hectic and stressful lifestyles and therefore there is     potential for this population to receive cognitive benefit from polyphenol consumption.   "
143077|NCT01411618|"     The daily removal of supragingival dental plaque is a major factor in the prevention of     caries, gingivitis and periodontitis. Proper control of bacterial plaque is obtained through     the mechanical removal of the biofilm by the proper use of the toothbrush and floss. However,     some studies have shown that the mean time of brushing tooth surfaces is less than that     required to obtain a proper cleaning 1 and only 2-10% of the patients use dental floss     regularly and effectively 2. In addition, it has been demonstrated that even after education     and motivation of the patient to the proper use of toothbrush and floss, its compliance is     reduced with time 3. The result is the persistence of plaque in some areas, particularly on     the interproximal surfaces of teeth. Many studies have demonstrated the effectiveness and     usefulness of antiseptic mouthwashes containing active ingredients such as chlorhexidine     (CHX) and essential oils (EO) to prevent and control the formation of plaque and gingivitis,     when used in addition to mechanical procedures 4-7. Chlorhexidine is still the gold standard     for its antimicrobial action and high substantiveness, but side effects, such as     pigmentation, taste alteration and the formation of supragingival calculus limit its     continued use 8. Essential oil (EO) mouthwashes have been used for years as an adjunct to     brushing in addressing oral hygiene. Their effectiveness in controlling plaque and gingivitis     are well documented in literature 9-14. They kill microorganisms by destroying their cell     walls and inhibiting their enzymatic activity 15,16. Furthermore, phenolic compounds like EOs     are known to interfere with the inflammation process 17,18. The antibacterial action is     particularly effective for the ability of the mouthwash with EOs to penetrate the biofilm     19-21. The traditional EO mouthwashes contain ethanol, a chemical used to dissolve numerous     substances in mouthwashes, including CHX. The concentration of ethanol present in the     mouthwash with EOs is more than 20%, sufficient to dissolve the EOs but not enough to carry     out a direct antibacterial effect 22,23. Many aspects against the use of alcohol in     mouthwashes, such as its effects on the surfaces of composite restorations 24 and its     possible role in the formation of oropharyngeal cancer are being discussed 25,26. Although a     direct correlation of the cause and effect between the occurrence of oropharyngeal cancer and     the use of mouthwashes with alcohol 27, has not demonstrated so far, it is considered     desirable to eliminate ethanol for use in daily mouthwash, bringing in search of new     formulations. Recently, an EOs containing mouthwash without alcohol was introduced on the     European market (Daycare, Curaden, Kriens, and Suisse). To our knowledge, to date there are     no published data on the effectiveness of this antimicrobial product. The rinsing with this     mouthwash can cause fewer side effects but, in contrast, it may be less effective.      The aim of this study was to evaluate the inhibitory properties of a new alcohol free EO     containing mouthwash with respect to the traditional mouthwash containing 21.3% ethanol,     through a standard 3-days plaque regrowth model.   "
143078|NCT01411605|"     Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major     efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is     associated with the development of weight-related comorbid conditions and increased     morbidity.      Regular physical activity is an important modality of obesity management. Despite     controversies, poor exercise tolerance has frequently been reported in youth obesity and the     cause of this limited exercise tolerance remains unknown. Several factors accompanying     obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such     as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary     volumes are associated with obesity and may impact exercise intolerance in this population.     Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to     exercise can become constrained in obesity. A thorough understanding of the mechanisms     underlying this exercise intolerance remains fundamental in order to favour long term     adherence to exercise training. This is especially true in youth populations, in which the     management of overweight and obesity must be undertaken as soon as possible, due to the early     onset of cardiovascular risk factors.      The main purpose of this study is to determine early-onset cardio-respiratory mortality     factors in obese adolescents as well as their relation with exercise intolerance (i.e.     dyspnea) when compared with age and gender-paired normal-weight volunteers.   "
143133|NCT01410890|"     -  The primary objective of this study is to characterize the pharmacokinetics of          alglucosidase alfa manufactured at the 4000 L scale in patients who have a confirmed          diagnosis of Pompe disease.        -  A secondary objective of this study is to evaluate and explore the relationship between          anti-rhGAA antibody titers and the pharmacokinetics of alglucosidase alfa.   "
143079|NCT01411592|"     The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic     RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the     impact of the adhesive system used an established resin cement with an integrated adhesive     monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with     Metal/Zirconia Primer) were compared within the study on a randomized basis.      The aim of the present randomized study was to evaluate wether the difference in bond     strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered     zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome     of all-ceramic RBFDP with a cantilevered single-retainer design.   "
143080|NCT01411579|"     One of the most recent and interesting field of diagnostic imaging is diffusion-weighted MR     imaging (DW-MRI). Various studies evaluated the application of DW-MRI to diffuse liver     disease and focal liver lesions providing controversial results, probably due to the     difficult reproducibility of the apparent diffusion coefficient (ADC) measurements. It is     conceivable that a wide inter/intra-individual variability actually exists in the apparent     diffusion coefficient (ADC)-values, and that each apparent diffusion coefficient (ADC)-value     presents an higher reliability in measuring the temporal changes of water diffusion within     the same individual (longitudinal-evaluation), than in characterizing tissues between     different patients (transverse-evaluation). For these reasons, some previous studies assessed     the application of DW-MRI in predicting the chemotherapy (CHT) outcome in liver metastases.     The rationale of these studies was the overt biochemical changes shown by the neoplastic     cells after CHT and the sensitivity of DW-MRI in the identification of such changes. The same     authors noticed that the metastatic lesions with the lowest ADC-values present also the best     outcome after CHT. Moreover, these studies suggest that it could be possible to assess if     each single patient will respond (R) or not (NR) to the CHT through liver DW-MRI performed     from 3 days to 3 weeks after the beginning of CHT.   "
143081|NCT01411566|"     The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic     patients with comorbid substance use disorder.   "
143082|NCT01411553|"     Null hypothesis: (1) there is no difference in rates of ICU-acquired infection based on using     disposable or cleaned, reusable ECG leadwires and (2) In cardiac surgical telemetry floors,     there is no difference in false or nuisance sightings or crisis calls based on using     disposable or cleaned, reusable ECG leadwires.   "
143083|NCT01411540|"     The purpose of this study is to compare a diet containing whole grains versus an energy     matched diet using refined grains on body composition and metabolism.   "
143084|NCT01411527|"     By clinical examinations and withdrawing of blood samples from a large number of healthy     Danish children, this study will reveal if age of pubertal onset is declining. Furthermore,     the extensive normative data will provide detailed insight into normal ranges and individual     changes of anthropometrics and hormone levels in healthy children during childhood and     adolescence.   "
143124|NCT01411007|"     The purpose of this study is to develop a technique to provide feedback of brain activity and     to use this technique to reduce levels of craving in nicotine dependent smokers. The     researchers will use a brain scan called functional magnetic resonance imaging (MRI). MRI     uses magnets to take pictures of your brain. Functional MRI measures brain blood flow that is     related to brain activity. This measure of brain activity can be presented or feedback to     volunteers.   "
143085|NCT01411514|"     The management of MS-patients requires treatment with immune-modifying or immune-suppressive     agents to prevent new relapses and progression of disability. Several studies have evaluated     the effect of steroid treatment on clinical recovery after an acute relapse. An important     unanswered clinical question is, whether or not an oral tapering dose of corticosteroids     offers any additional advantage over intravenous methylprednisolone alone in improving     neurologic recovery as well as safety and tolerability after a relapse.      This study aims to compare the efficacy, tolerability and safety of tapering doses of oral     prednisone and placebo after short-term high-dose i.v. methylprednisolone on the recovery     from an acute relapse in patients with clinically isolated syndrome (CIS),     relapsing-remitting multiple sclerosis (RR-MS) and primary (PP-MS) or secondary progressive     multiple sclerosis (SP-MS) with superimposed relapses.      Patients will be treated during 25 days with de-escaling doses of prednisone or placebo.      The primary analysis will test whether placebo is equivalent to oral prednisone taper on the     recovery status as measured by EDSS change from baseline to 3 months after baseline.   "
143086|NCT01411501|"     A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25     has the same effect as lactulose in unaided self-defecation frequency of a week and has     better effect in symptoms improvement (in press). The object is to evaluate whether     acupuncture is effective for functional constipation. As an explanatory research, it took one     single point as its intervention and sham acupuncture as its control group (patients were     blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized     controlled trial to further evaluate whether acupuncture is more effective than routine     treatment. Acupuncture prescriptions used in this trial are individually prescribed according     to syndrome differentiation, which can improve clinical effect. .   "
143087|NCT01411488|"     The purpose of the study is to determine the prevalence of anal erosions within a 14 day     period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal     management systems (FMS).      Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal     management systems in a 14 day period.      Alternative Hypothesis: One fecal management system is no worse than the second fecal     management system in the development of anal erosion.   "
143088|NCT01411475|"     The LATINA registry aims at assessing a new classification of bifurcation restenosis in the     prediction of major adverse cardiac events in patients who have previously undergone a     succesful percutaneous bifurcation intervention.   "
143089|NCT01411462|"     VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by     the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which integrates     a predilation catheter with electronic intravascular ultrasound capabilities.   "
143090|NCT01411449|"     This study is a regulatory post marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Primovist for contrast     enhancement in MRI of liver. The objective of this study is to assess safety, especially in     relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total     2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and     followed 7 days after the injection.   "
143146|NCT01410721|"     Up to half of all military service members with combat-related traumatic brain injury (TBI)     also suffer from Posttraumatic Stress Disorder (PTSD). TBI and PTSD are each associated with     cognitive problems in what are called 'executive functions' such as planning actions,     inhibiting behavior, monitoring one's own thoughts and feelings, and solving problems     day-to-day. These types of impairments occur more often among veterans with both TBI and PTSD     than among those with only one of these conditions. The combination of TBI and PTSD in     veterans has also been linked to problems with anger and violence, which are common     complaints of veterans seeking mental health services post-deployment and have been shown to     predict poor treatment outcomes in Iraq and Afghanistan veterans.      Although the relationship between combined TBI/PTSD diagnoses and post-deployment adjustment     problems has been demonstrated, there has been little research into clinical interventions     designed to reduce the severity of cognitive and affective symptoms in veterans with both TBI     and PTSD. Therefore, the investigators propose a randomized clinical trial involving a     cognitive rehabilitation intervention that targets improved executive functioning, with the     participation of N=100 veterans diagnosed with both TBI and PTSD (n=50 in experimental group     and n=50 comparison).      As part of the study, all participants will receive an iPod touch. Participants will be     placed into one of the two study groups randomly. Based on which group participants are     placed in, they will receive one of two different sets of iPod touch apps and programs that     address and aim to improve different facets of cognitive functioning. Regardless of which     group, Veterans will be instructed to daily practice iPod touch applications on cognitive     functioning. Also, family members will be trained as mentors to reinforce use of the     applications in everyday living environments. Trained facilitators will also travel to     participants' homes to meet with veterans and family to observe behaviors in the home     environment, arrive at strategies for applying new skills in their situations, troubleshoot     any iPod technical problems, and review family mentoring processes.      The investigators will measure clinical outcomes using a comprehensive array of functional     and structural methods at baseline and six months. The investigators hypothesize improved     executive function among those in the experimental group as well as reduced     irritability/impulsivity and improved social/occupational functioning. The investigators     further hypothesize that, as a group, veterans participating in the cognitive rehabilitation     program will show significant changes in neural activity associated with executive functions     when comparing pre- and post-treatment EEG and fMRI responses.      Better understanding of the neural circuitry and neurocognitive function underlying executive     function and associated affective control deficits in veterans with both TBI and PTSD, and     how they relate to treatment outcome, will allow us to better identify therapeutic targets     for cognitive rehabilitation. The current proposal aims to explore the relationship between     brain function and connectivity in selective pathways/circuits, neuropsychological     functioning, and cognitive rehabilitation response in veterans with both TBI and PTSD.      This study of the neurobiology and neuropsychology associated with intervention efficacy will     allow us to identify veterans with both TBI and PTSD who are predisposed to positive     treatment outcomes. To our knowledge, this will be the first attempt to integrate     neurobiological and neurocognitive techniques with information about the efficacy of a     theoretically and empirically driven cognitive rehabilitation intervention in veterans with     combined TBI/PTSD diagnoses. This research may suggest additional avenues for assessment of     clinical intervention efficacy and the identification of therapeutic targets (e.g. alteration     of function in fronto-limbic circuits) relevant to the military population. Given links     between TBI/PTSD, executive dysfunction, and anger, impulsivity, and aggression, efforts to     rehabilitate cognitive function will be particularly important to ensure that current and     future veterans adjust successfully when they return home to their families, workplaces, and     communities.   "
143147|NCT01410708|"     This study will examine the anti-tumor activity, safety and tolerability of dasatinib in     adjuvant breast cancer patients in a pre-surgical setting.   "
143091|NCT01411436|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Nexavar for unresectable     hepatocellular carcinoma (HCC). The objective of this study is to assess safety and     effectiveness of Nexavar under real-life practice conditions. This study is an all case     investigation of which the enrollment period is 2 or 3 months (dependent on sites) for     Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with     Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be     recruited and followed one year since starting Nexavar administration.   "
143092|NCT01411423|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have been administered with Nexavar for     unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess     safety and effectiveness of Nexavar under real-life practice conditions. This study is an all     case investigation of which the enrollment period is 15 months, and all patients who received     Nexavar will be recruited and followed one year since starting Nexavar administration.   "
143093|NCT01411410|"     This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946     in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the     recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will     involve multiple participating sites from the US. Following determination of the MTD, an     expansion cohort of 20 evaluable subjects with breast cancer was planned. Finally, 16     patients have been enrolled to treatment (Cohort 3). A new expansion cohort with modified     dosing cohort is now introduced (Cohort 4: breast cancer expansion cohort with modified     dosing) in which another 20 subjects are planned to be enrolled to treatment.   "
143094|NCT01411397|"     Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair     in elective situations is documented, and many studies have reported beneficial outcomes of     mesh hernioplasty in emergency situations. Still there is controversy of using such grafts in     presence of intestinal resection.   "
143095|NCT01411384|"     This study attempts to compare Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF) in     a series of keratoconic eyes before and after Corneal collagen cross-linking (CXL).     Furthermore, among the objectives of the study is to reveal correlations between CH and CRF     and a series of corneal indexes like the Corneal Thickness (CT), mean keratometry (Km) and     corneal astigmatism (Astig).      The study adhered to the tenets of the Declaration of Helsinki and written informed consent     was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ),     in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing     primarily on the conditions of the anterior segment of the eye.      Participants were recruited from the Outpatients Cornea service of the EIT in a consecutive     if eligible basis. Fifty (50) eyes of thirty (30) patients with keratoconus were recruited     for the sake of the study and formed the keratoconus group (KG). Eligible subjects for the     keratoconus group had to present progressive keratoconus in consecutive corneal topographies,     changes in refractive power, and deterioration of the visual acuity within a period of two     years. Exclusion criteria included glaucoma, glaucoma suspicion, and intraocular pressure     (IOP) lowering drugs administration. Further to glaucoma, exclusion criteria included central     corneal thickness (CCT) less than 400μm, K-readings more than 60D, a history of herpetic     keratitis, corneal scarring, severe eye dryness, pregnancy or nursing, current corneal     infection, or underlying autoimmune disease.      Fifty (50) eyes of fifty (50) non-keratoconic, age-matched, individuals who visited our     outpatient service formed the control group (CG). Further to keratoconus, and a spherical     equivalent error above 3D, the same exclusion criteria applied to the control group members,     as well. All participants wearing contact lenses were instructed to discontinue contact lens     wear at least a month before measurements.      CRF and CH parameters were obtained while the patient was sitting on a chair in front of the     Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device.     Upon successful fixation of the patient's eye on a red blinking target, the operator     activated the device. An air puff was released by a non-contact probe, which scanned the     central area of the eye and sent a signal to the ORA. In brief, the air puff causes the     cornea to move inward, past applanation, and into slight concavity. After milliseconds, the     air pumps shut off, the pressure decreases, and the cornea begins to return in its normal     state. The system monitors the entire process and measures two pressure values, which are     determined from the inward and outward applanation processes. The aforementioned measuring     procedure enables the determination of CH which is related to the viscoelastic structure of     the corneal tissue, and is calculated as the difference between the two pressure values at     the two applanation processes, and CRF which is indicative of the overall resistance of the     cornea and is calculated as a linear function of the two pressures associated with the two     applanation. In order to ensure accurate results, ORA was done four times for each eye, by     the same operator. Signals that differ significantly in appearance from the other signals     from the same eye were deleted.      The same surgical procedure was applied to all keratoconus patients that included:     Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of     a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent     de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of     0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops     every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and     aqueous was stained yellow. The ultraviolet A (UVA) radiation source that was used is UV-XTM     (IROC AG, Zurich, Switzerland). In details, an 8.0mm diameter of central cornea was     irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of     3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during     irradiation, as well, in order to sustain the necessary concentration of the riboflavin.     Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.      After treatment all patients were prescribed topical ofloxacin drops qid, fluorometholone qid     and diclofenac nitrate qid, accompanied by frequent instillation of artificial tears. Soft     therapeutic lens was applied until complete re-epithelialization of the cornea was detected.     Follow up visits were performed on the 1st day, 7th day, 1st, 3rd, 6th and 12th month after     the operation.   "
143096|NCT01411371|"     Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity     and mortality associated with the other. The investigators hypothesized that restoration of     normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart     failure. This study randomizes patients with heart failure and persistent AF to medical     treatment of AF or catheter ablation to restore sinus rhythm.   "
143097|NCT01411358|"     The purpose of this study is to evaluate the antibody response to each of the three influenza     vaccine strains included in the licensed seasonal flu vaccine, as measured by     hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly     subjects in compliance with the requirements of the current European Union (EU)     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed     flu vaccine (CPMP/BWP/214/96).   "
143099|NCT01411332|"     1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the          dominant tumor lesion in the prostate as identified by multiparametric MRI will increase          tumor eradication from the prostate.        2. Biomarker expression levels differ in the multiparametric MRI defined regions at high          risk of harboring tumors that determine outcome.        3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related          to an adverse treatment outcome.        4. Quality of life will not differ significantly between the treatment arms.        5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients          will be aware that the dominant tumor will be targeted with higher radiation dose.   "
143100|NCT01411319|"     The hypotheses of this study are:        1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to          the dominant tumor lesion(s) in the prostate as identified by multiparametric functional          Magnetic Resonance Imaging is safe and feasible.        2. Biomarker expression levels differ in the functional MRI identified suspicious tumor          regions and unsuspicious tumor regions. The investigators hypothesize that a significant          source of variation in biomarker levels is due to tumor heterogeneity and that it is          molecular abnormalities in the dominant tumor areas that are angiogenic and determine          outcome.   "
143101|NCT01411306|"     Despite medical advances, half of the patients admitted to hospital for recovery from acute     illness, injury or surgery have swallowing difficulties and those requiring tubes for     breathing support are at even greater risk. Difficulties with swallowing decrease patients'     quality of life, prolong their hospital stay, as well as lead to medical complications such     as pneumonia, malnutrition and death. Presently, there is no screening test for swallowing     difficulties in patients who have required respiratory support. Screening will allow for     early detection of swallowing problems which is important to prevent serious complications,     such as pneumonia. This research will determine the accuracy of a new screening test, the     Toronto Bedside Swallowing Screening Test (TOR-BSST©) previously tested with stroke patients,     to predict the presence of swallowing difficulties in patients who have required breathing     support for longer than 48 hours. The investigators will enroll 100 patients from the     intensive care medical surgical units at the University Health Network. The findings from     this research will help identify those patients with swallowing problems earlier than it is     currently possible. Once identified, at risk patients will be referred to a speech language     pathologist swallowing expert for more comprehensive testing; thereby, decreasing their risk     of experiencing serious complications, such as pneumonia, secondary to swallowing problems.   "
143436|NCT01406925|"     This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of     NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.   "
143102|NCT01411293|"     The purpose of this study is to define whether the acute consumption of low-fat milk protects     against postprandial vascular endothelial dysfunction by reducing oxidative stress responses     that limit nitric oxide bioavailability to the vascular endothelium. The investigators     hypothesis is that the consumption of low-fat milk will improve postprandial vascular     endothelial function in an oxidative stress-dependent manner that allows greater nitric oxide     (NO) bioavailability. The objectives of this study are to 1) examine improvements in     postprandial vascular endothelial function in response to low-fat milk ingestion, 2) define     low-fat milk-mediated improvements in circulating biomarkers of redox status, and 3) define     the mechanism by which low-fat milk improves NO bioavailability. Collectively, the successful     completion of these studies is expected to define NO mediated activities of low-fat milk that     protect against vascular endothelial dysfunction in individuals at high risk for developing     CVD.   "
143103|NCT01411280|"     The purpose of this study is to assess whether methylphenidate is effective in enhancing the     cognitive performance of children with the HbSS or HbSC genotype of SCD who have sustained     neurological complications on laboratory-based measures of sustained attention, reaction     time, and executive functions, and indirectly, verbal short-term and long-term memory.   "
143104|NCT01411267|"     This is a phase I study of the investigational drug AC220 combined with cytarabine and     etoposide in patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous     leukemia (AML).   "
143105|NCT01411254|"     This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for     diabetic macular edema.   "
143106|NCT01411241|"     The aim of the study is to assess whether the second CYD dengue vaccination could be     administered concomitantly with the booster vaccination of a pediatric combination vaccine     (Pentaxim™) during the same day and visit but in 2 different sites of administration.      Primary Objective:        -  To demonstrate the non-inferiority of the antibody response against all antigens          (diphtheria, tetanus, pertussis, polio and Hib) in participants receiving one booster          dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue          vaccine compared to subjects receiving one booster dose of Pentaxim™ vaccine          administered concomitantly with placebo.      Secondary Objectives:        -  To describe the safety of Pentaxim™ vaccine administered concomitantly with the second          dose of CYD dengue vaccine, or administered concomitantly with placebo.        -  To describe the safety of the CYD dengue vaccine in all subjects after each dose.        -  To describe the antibody response to each dengue virus serotype (post-Dose 2 and          post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with          Pentaxim vaccine or administered alone.        -  To describe the antibody response to each dengue virus serotype post-Dose 2 and          post-Dose 3 in all subjects.   "
143107|NCT01411228|"     A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in     pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher     disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase)     or PB-06-005 (naïve treatment with taliglucerase alfa).   "
143125|NCT01410994|"     The purpose of the project is to study the relationship between post-bariatric surgery     changes in weight and renal parameters.   "
143177|NCT01410318|"     The overall objective of this study is to characterize the prevalence and progression rate of     subclinical atherosclerotic lesions and to study their association to the imaging     characteristics of atheroma plaques and to the presence of genetic, epigenetic, metabolomic,     and environmental factors, including dietary habits, physical activity, biorhythms,     psychosocial characteristics, and exposure to environmental pollutants   "
143108|NCT01411215|"     This is an open-label, multicenter and observational study in China, which is designed to     record the data of RA & AS patients within 52 weeks after rheumatologists decided to     prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible     subjects agreed to be recruited in the study and can withdraw anytime if they choose so.      Patients with RA or AS are typically managed by rheumatologists. As this study seeks to     record the data of RA & AS patient in etanercept and evaluate the safety and efficacy of the     treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked     to build up the database for RA & AS patient surveillance prospectively in outpatient dept,     which benefits for the patient treatment outcomes evaluation and clinical management.   "
143109|NCT01411202|"     Patients with cancer may experience problems with their breathing due to a fluid accumulation     around their lungs called malignant pleural effusion (MPE). This fluid can be drained but     draining may not stop the fluid from accumulating again. MPE can cause shortness of breath     during activity and at rest leaving patients feeling as though they cannot catch their breath     enough to be comfortable. Other symptoms can include pain, cough and weight loss.      One way to stop the fluid from accumulating is to create scar tissue between the lung and     chest wall so there is no more room for fluid accumulation. This procedure is called     pleurodesis. Pleurodesis is the standard of care at most centres across Canada. This     procedure is done by injecting a drug into the space between the lung and chest wall through     a catheter, Doxycycline is one of the drugs currently used for this purpose. Traditionally,     patients are admitted for pleurodesis, mostly because the size of the catheter used to inject     the medication is very large but also because of the potential complications that can happen     with these larger chest tubes.      At our centre, most patients with MPE are managed at home with a smaller sized catheter known     as a Pleurx catheter. The Pleurx catheter allows patients to remain at home for treatment and     trained staff come into the home to both drain the MPE and monitor the patient. Sometimes,     patients experience pleurodesis through use of the Pleurx catheter alone.      Pleurodesis with doxycycline can happen faster than with the Pleurx catheter alone. It has     been our experience with a limited number of patients that it is safe to perform pleurodesis     using the Pleurx catheter for doxycycline injection in an outpatient setting.   "
143110|NCT01411189|"     Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy,     endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal     resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric     spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic     therapeutic procedures will be evaluated based on the proportion of patients with suppressed     gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by     an independent committee.      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions     (ADRs) observed between administration and seven days after administration.   "
143148|NCT01410695|"     The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to     methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid     arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least     one biologic drug if patients previously failed methotrexate or to 3. methotrexate in     combination with any DMARD including biologic drugs.   "
143111|NCT01411176|"     Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy,     such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will     receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as     anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment     design based on the proportion of patients with suppressed gastric peristalsis during the     procedures. The degree of gastric peristalsis is assessed by an independent committee.      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions     (ADRs) observed between administration and seven days after administration in comparison with     the placebo group.   "
143112|NCT01411163|"     The purpose of this clinical trial is to extend the Pre-Crest-X study to further assess the     long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for     Huntington's Disease (HD) and to assess whether biomarkers responsive to creatine in     symptomatic individuals are informative in premanifest individuals over a longer duration.   "
143113|NCT01411150|"     The purpose of this clinical trial is to extend the Pre-Crest study (Protocol # (NCT00592995)     to further assess the long-term safety and tolerability of up to 30 grams daily creatine in     individuals at-risk for Huntington's Disease (HD) and to assess whether biomarkers responsive     to creatine in symptomatic individuals are informative in premanifest individuals over a     longer duration.   "
143114|NCT01411137|"     The study had three distinct parts and is described as follows:      Part 1:        -  To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD          IR to IPX066 in subjects with advanced PD        -  To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an          exploratory computer-based system, in assessing dexterity and mobility in a subset of PD          subjects.      Part 2:      • To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions     in eligible subjects who successfully completed Part 1 of the study.      Part 3:      • To further evaluate the long-term safety of IPX066 in eligible subjects who successfully     completed Part 2.   "
143115|NCT01411124|"     This is a double-blind, placebo-and active-controlled 3-period crossover study designed to     assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.   "
143126|NCT01410981|"     The purpose of this study is to understand if small proteins found on the surface of myeloma     cells (called CXCR4 and CD47) or inside the myeloma cells (Pim kinases, sphingolipids, and     pS6) can predict how patients will respond to chemotherapy-treatment and if a small molecule     inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma. A     sample from the bone marrow biopsy (a small amount of tissue removed from the body for     laboratory testing) and aspirate (a small amount of fluid is removed from the body for     laboratory testing) that had been done before the subject entered this study will be provided     for research purposes. Based on preliminary data, it is hypothesized that CXCR4, CD47,     sphingolipids, and Pim kinases could be used as prognostic/predictive markers and that Pim     kinase inhibitors provide a new agent for the treatment of multiple myeloma.   "
143116|NCT01411111|"     Leukotrienes are potent inflammatory molecules produced mainly by mast cells, eosinophils,     monocytes/macrophage and neutrophils in response to allergic or inflammatory stimuli.     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that     attenuates the production of leukotrienes, through the blockage of the first committed step     in the leukotriene pathway, 5 lipoxygenase (5-LO) activation.      GSK2190915 has been shown to be an in vitro inhibitor of human organic anion transporting     polypeptides 1B1 and 1B3 (OATP1B1 and OATP1B3), hence there is a potential for a     pharmacokinetic drug-drug interaction with OATP1/ B1 substrates such as the anti-lipidemic     rosuvastatin.      This study will evaluate the effect of repeat oral dosing of GSK2190915 (30milligram (mg) and     100mg) on the steady-state pharmacokinetics (PK) of rosuvastatin (10 mg). In addition, the     study will evaluate the safety and tolerability of this combination when co-administered to     healthy, adult volunteers in two cohorts.   "
143117|NCT01411098|"     This phase I trial studies the side effects and best dose of radiation therapy when given     together with cisplatin and etoposide in treating patients with non-small cell lung cancer     that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor     cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,     or by stopping them from spreading. Drugs, such as cisplatin, may make tumor cells more     sensitive to radiation therapy. Giving radiation therapy together with cisplatin and     etoposide may kill more tumor cells.   "
143118|NCT01411085|"     Note: In June 2013, the study design was changed from a randomized controlled study of     risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of     risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to     read:        1. To determine whether participants treated with risperidone in combination with          desiprmaine have less alcohol use (fewer drinking days; fewer heavy drinking days)          during the final 8 weeks on these medications as compared to pre-baseline. The primary          hypothesis is that compared to pre-baseline, participants will demonstrate fewer days of          drinking (per week), as well as fewer days of heavy drinking (per week) in the final          eight weeks they are taking risperidone and desipramine, as recorded on the Timeline          Follow-Back assessment        2. To explore changes in symptoms (of schizophrenia and of depression) in the final eight          weeks of treatment with risperidone + desipramine compared to the period before baseline        3. To assess the side effect burden associated with the combination of these two          medications in participants.      The original aims of the study were:      The purpose of this study is to determine whether participants who are treated with     risperidone in combination with desipramine have less alcohol use (fewer drinking days; fewer     heavy drinking days) than do participants who are treated with RISP with placebo. The primary     hypothesis is that compared to treatment with risperidone, participants randomized to a     combination of risperidone plus desipramine will have fewer days of drinking, as well as     fewer days of heavy drinking. The study will also compare the effects of risperidone as     compared to risperidone plus desipramine on participants' symptoms and side effects.   "
143119|NCT01411072|"     Chemotherapy is given after curative surgery for pancreas cancer to try to improve cure     rates. There are two choices of chemotherapy which are currently considered equal treatments:     gemcitabine or 5-fluorouracil (5FU). This study is trying to determine if one of two standard     chemotherapies is better than the other depending on whether patients have high or low human     equilibrative nucleoside transporter 1 (hENT1). hENT1 is a protein that is found in varying     amounts on pancreas cancers.   "
143149|NCT01410682|"     Critical care nursing interventions related to oral care can reduce the microorganisms in the     oropharynx available for translocation to other sites. THis is a randomized, controlled and     double blinded study performed in a pediatric intensive care unit (PICU) from a Brazilian     university hospital which objectives were to analyze 0.12% chlorhexidine digluconate     influence on Gram-negative pathogens colonization of oropharyngeal and tracheal secretions of     mechanically ventilated children.   "
143120|NCT01411059|"     This is an Intervention Development Study (IDS) to quantify the physical demands (using     biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program     designed for community-dwelling older adults. Additionally, the IDS will explore the     adherence and adverse events of participation in the program. Data from the IDS will be used     to develop evidenced-based yoga programs, which the investigators postulate will be     associated with fewer musculoskeletal side effects compared to non-evidence based yoga     programs. The investigators also postulate that evidenced-based tailoring of yoga for seniors     will enhance adherence and efficacy. The programs developed during this IDS will be tested in     an expanded, Phase II, Randomized Controlled Trial.   "
143121|NCT01411046|"     Development of glucocorticoid (GC)-induced adrenal insufficiency is a serious adverse effect     of GC treatment. It is today not possible to predict this adverse effect. The project aims at     investigating a possible individual aspect, which may render subjects more or less sensitive     to glucocorticoids, and thereby influence development of GC induced adrenal insufficiency.     The hypothesis is that subjects with one or another of the polymorphisms in the GC receptor     gene will either have increased or diminished GC sensitivity. This may be responsible for     differences in development of GC induced adrenal insufficiency.   "
143122|NCT01411033|"     The purpose of this study is to evaluate the development and progression of chronic     complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular     events) in patients with type 1 diabetes treated from the onset of the disease with     recommended method of intensive insulin therapy. All patients attended a five-day structured     training program during first hospitalization and re-education once year during the     observation. After five years of observation and next - once a year chronic complications are     assessed. The investigators would like to evaluate also the relationship of the management of     the disease, knowledge about the treatment and diabetes, insulin resistance and inflammatory     markers with development and progression of chronic complications.   "
143123|NCT01411020|"     The purpose of this study is to determine a effect-site concentration of propofol in children     3 to 11 years effective to make a induction of general anesthesia.   "
143178|NCT01410305|"     The relationship of Vitamin D levels in children and young adults to atherosclerosis.   "
143128|NCT01410955|"     Irinotecan is one of key drug used in the treatment of colorectal cancer. The incidence of     irinotecan induced diarrhea varies between 60-90%, with severe diarrhea in 20-40%. The main     cause of diarrhea is one of irinotecan metabolites, SN-38 which is in the liver     glucuronidated and subsequently expelled into the intestine. Due to the bacterial enzyme     beta-D-glucuronidase in intestinal lumen it is deconjugated. This form causes direct damage     of intestinal mucosa associated with malabsorption and the development of diarrhea. It is     known that probiotic bacteria, reduce activity of intestinal beta-D-glucuronidase and     therefore these bacteria could be applied in the prevention of diarrhea in patients treated     by this food supplement. Given their low toxicity, good tolerability, probiotics may be an     important part of supportive therapy. This is a first study aimed to determine the     effectiveness of the probiotics in the prophylaxis of irinotecan induced diarrhea due to     reduction intestinal beta-D-glucuronidase activity.   "
143129|NCT01410942|"     The goal of this clinical research study is to learn about the effect of different     combinations of exercise, supportive counseling, and methylphenidate/placebo for the     treatment of fatigue in patients with prostate cancer. The safety of this treatment     combination will also be studied.      Methylphenidate is a stimulant designed to increase the activity of the central nervous     system.      A placebo is not a drug. It looks like the study drug but is not designed to treat any     symptom, disease or illness. It is designed to be compared with a study drug to learn if the     study drug has any real effect.      The exercise in this study is designed to help improve your physical fitness and energy     levels.      Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression,     pain, and/or sleep disorders.   "
143130|NCT01410929|"     The objective of this post market clinical study is to collect prospective clinical data to     confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the     spine caused by multiple myeloma.   "
143131|NCT01410916|"     This protocol is designed to collect safety and efficacy data on patients that have been or     will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in     Germany.   "
143132|NCT01410903|"     The purpose of this study is to evaluate source data for the survival and the investigation     of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.   "
143452|NCT01406704|"     This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic     acid, antioxidant on patients with pathologically proved NASH (non-alcoholic     steato-hepatitis).   "
143134|NCT01410877|"     It is hypothesized that different inhalation profiles (inhalation flow rate versus time     curves) result from different forms of patient training. Furthermore, significant     inter-subject variability in these profiles should exist that can, under some circumstances,     depend on the design of different inhalation devices; this is because dry powder inhalers     have different airflow resistances. The investigators also hypothesize that the spread of     flow rate versus time profiles for inhalation can be collected. Finally, these profiles can     be analyzed from a group of human subjects and used to define a mean and statistical range of     inhalation flow rate versus time curves.      The investigators propose to collect the inhalation profiles from 20 'inhaler naïve' healthy     volunteers after they have (a) read a typical inhaler package insert and (b) been formally     trained in inhaler use by a pharmacist. No drug exposure will occur. The data will be used     from this pilot study to (a) show the inter-subject variability in the inhalation profiles     used by adults inhaling through realistic airflow resistances (like those in inhalers)     following different types of training (b) show how formal training changes inhalation     technique and (c) provide a database of typical inspiratory profiles for use and improvement     of realistic tests of inhalers in the laboratory. Since pulmonary deposition from inhalers     greatly depends upon the way patients inhale through them, this research will result in a     database to improve the design and in vitro characterization of inhalers.   "
143135|NCT01410864|"     This is a non-randomized, post-approval study to further evaluate the rate of post-operative     Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive     DuraSeal Exact Spine Sealant System.   "
143136|NCT01410851|"     Pulses have the potential to be positioned as a food for body weight and metabolic control     based on their composition, effects on rate of digestion and absorption of fat and     carbohydrates, and effects on satiety. However, the role of individual pulses incorporated     into a mixed meal on regulation of food intake, satiety and glycaemic control remains     unclear. Therefore, the objective of our study was to determine the effects of ad libitum     consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food     intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.   "
143137|NCT01410838|"     This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately     prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and     fat regain following a period of moderate, yet clinically significant weight loss.   "
143138|NCT01410825|"     The Wiskott-Aldrich Syndrome (WAS) is an inherited disorder that results in defects of the     blood and bone marrow. It affects boys because the genetic mistake is carried on the X     chromosome. Normal people have blood cells called platelets that stop bleeding when blood     vessels are damaged. Boys with WAS have low numbers of platelets that do not function     correctly. Boys with WAS are thus at risk for severe life-threatening bleeding. A normal     immune system is made of special blood cells called white blood cells, which protect against     infection and also fight certain types of cancer. In WAS, these white blood cells don't work     as well as they should, making these boys very susceptible to infections and to a form of     blood cancer known as lymphoma. The abnormal white blood cells of patients with WAS also     cause diseases such as eczema and arthritis. Although WAS can be mild, severe forms need     treatment as early as possible to prevent life-threatening complications due to bleeding,     infection and blood cancer.      Over the past decade, investigators have developed new treatments based on the investigators     knowledge of the defective gene causing WAS. The investigators can now use genes as a type of     medicine that will correct the problem in the patient's own bone marrow. The investigators     call this process gene transfer. The procedure is very similar to a normal bone marrow     transplant, in that the old marrow is killed off using chemotherapy, but is different because     the patient's own bone marrow is given back after it is treated by gene transfer. This     approach can be used even if the patient does not have any matched donors available and will     avoid problems such as GVHD and rejection. The investigators wish to test whether this     approach is safe and whether gene transfer will lead to the development of a healthy immune     and blood system.   "
143139|NCT01410812|"     The investigators propose that healthy behaviors such as exercise could be increased through     the use of tying devices - mechanisms that force a coupling of addictive activities     (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior     (exercise).   "
143140|NCT01410799|"     The purpose of the study is to evaluate the effect of a naturally occurring hormone, called     Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body.     GHRH stimulates the production of growth hormone (GH), which regulates the build up of many     tissues in the body, including muscles and bones. Many elderly people have low levels of GH.     The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH     and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in     four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass,     physical performance, and how the body uses sugar.   "
143141|NCT01410786|"     The purpose of this prospective clinical data-collection is to document the performance and     clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and     Conventional Instrumentation.   "
143142|NCT01410773|"     The purpose of this study is to demonstrate that untrained subjects with diabetes can use an     investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from     fingerstick and from Alternative Site (AST) Palm .   "
143143|NCT01410760|"     The PERFORM study is a pilot study investigating the feasibility and usefulness of performing     a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to     normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to     FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be     invited to take part. FOXFIRE is a national randomised controlled trial in which patients     with unresectable liver tumours secondary to colorectal cancer will receive treatment with     standard chemotherapy alone, or with chemotherapy in combination with an internal     radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its     own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be     performed prior to the start of treatment and also three months after the commencement of     treatment to assess the cancer's response to treatment, particularly whether the tumour has     changed in size as a result of treatment. Perfusion CT gives the normal information on     changes in tumour size but also assesses whether the blood flow to the cancer has changed,     which may allow earlier identification of treatment success compared to normal CT scans. All     patients consenting to participate in the PERFORM study will undergo four perfusion CT scans:     one before the treatment starts, and one at the start of each of the second, third and fifth     cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion     for data analysis using perfusion CT and to establish if the tumour perfusion pattern at     baseline or shortly after the start of therapy can predict response to radioembolisation or     chemotherapy. This research is funded by the National Institute for Health Research     Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.   "
143144|NCT01410747|"     To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.   "
143145|NCT01410734|"     The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides     real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as     identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile     duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.   "
143150|NCT01410669|"     This project is a randomized trial to determine if motivational interviewing (MI) is an     effective intervention to help women in abusive intimate relationships. The study objective     is to motivate abused women to identify and achieve their own specific goals that can help     them address the violence in their lives. This project will be integrated into the setting of     a busy family planning clinic in the mid-western United States, which serves a largely rural     population. Intimate partner violence (IPV) is screened using the Women's Experience with     Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger Assessment     Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled, randomized     to the intervention or to usual care group, and complete the 6-month study protocol. All     subjects complete a self-administered computer-based questionnaire at the initial and 6-month     follow up visits to measure self-efficacy (primary outcome), stage of readiness to change,     selected IPV-related health correlates (e.g., depression), and steps taken and resources     used. The MI intervention is an active listening counseling technique aimed at guiding the     patient towards identifying feasible, personalized goals and steps she can take to increase     her self-efficacy and control in the relationship. The trained study interviewer will work     with participants to identify steps they can safely take and local resources to help them     meet their goals. The MI protocol consists of a face-to-face counseling session at baseline     with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to     reinforce the intervention and assess the participants' level safety. The control group will     receive usual care, which includes talking with a Level 3 Domestic Violence Advocate and     receiving a comprehensive list of domestic violence resources. Effectiveness of the MI     intervention will be determined by increased self-efficacy, measured by the Domestic Violence     Coping and Self-Efficacy Scale, a validated tool for use among women with a recent history of     domestic abuse; and by a reduction in depressive symptoms (CESD-10). The impact of the     intervention will be assessed by an increase in participants' readiness-to-change, and extent     of their involvement in a wide variety of self-help and coping activities over the follow-up     period. If successful, this screening and intervention program will be translated to other     clinical settings.   "
143151|NCT01410656|"     The primary purpose of the study is to determine the effects of an implementation intention     intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims     are to (a) compare the effects of a telephone-assisted implementation intention intervention     against a self-administered implementation intention intervention and a standard     recommendation group on physical activity behaviour and (b) document the effects of these     interventions on quality of life (QoL), fatigue, symptom management, and physical     functioning.      Hypotheses: Evidence exists that an implementation intention intervention can lead to     significant improvements in PA levels and that regular PA has been shown to improve QoL,     fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As     such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the     researcher-assisted implementation intention intervention will have higher PA levels at the     1- and 3-month follow-ups compared to the self-completed implementation intention     intervention and the standard recommendation group; (2) prostate cancer survivors in the     researcher-assisted implementation intention intervention will show significant improvements     in QoL, fatigue levels, symptom management, and physical functioning compared to the     self-completed implementation intention intervention and the standard recommendation group at     the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed     implementation intention intervention will have higher PA levels, and better improvements in     QoL, fatigue levels, symptom management, and physical functioning compared to the standard     recommendation group at the 1- and 3-month follow-ups.   "
143179|NCT01410292|"     The aim of this study is to assess the post-prandial response of four breakfast with     different content of dietary fiber and glycemic index on glycemic response and satiety in     patients with type 2 diabetes.   "
143180|NCT01410279|"     The purpose of this study is evaluate the effect the inspiratory muscle training on the     functional capacity of patients with pulmonary hypertension.   "
143181|NCT01410266|"     The purpose of this study is to determine whether an alternative method of follow-up after     medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.   "
143182|NCT01410253|"     Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on     recovery of functional capacity, pulmonary function and respiratory muscle strength in the     period of hospital stay after coronary artery bypass graft.   "
143152|NCT01410643|"     Puberty represents a critical period in terms of metabolic health. Racial differences in     insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a     female's health later in life. Further, the peripubertal period is likely the period of     racial divergence in adiposity noted between European American (EA) and African American (AA)     girls. Diet is a major modifiable risk factor. The identification of simple, cost-effective     dietary strategies for prevention and management of metabolic disease and excess fat mass     accrual during the peripubertal period is a priority. Modification of the diet to affect     metabolic and endocrine outcomes with and without weight loss during the pubertal transition     represents a novel approach to the pediatric obesity epidemic.      It is likely that the two diets used in this project will have different metabolic effects,     including effects on postprandial glycemia, triglyceride concentration, free fatty acid     concentration, and satiety. These factors may in turn, affect development of metabolic     perturbations, especially in susceptible individuals (e.g. AA peripubertal girls).The role of     carbohydrates on metabolic outcomes, particularly among children, has received little     attention. It has been hypothesized that higher postprandial glycemia may be a mechanism for     disease progression. Development of a diet that reduces insulin secretion and optimizes     metabolic-endocrine health among peripubertal girls will likely reduce obesity and related     co-morbidities and future reliance on pharmacologic treatments, even in the absence of weight     loss. However, in light of the current trends in pediatric obesity, a safe and effective     regimen that also promotes weight loss is needed for the pediatric population.      This proposal is significant in that it will shed light on whether diet composition, as a     part of a eucaloric (weight-stable) or hypocaloric diet (weight-loss) can influence the     hyperinsulinemic characteristic of AA peripubertal girls. Existing data suggest that elevated     concentrations of insulin and/or reproductive hormones may contribute to the fat mass accrual     in AA and could elevate risks for development of chronic diseases in adulthood. The results     of this study will lead to the development of dietary means for the reduction of insulin, and     thereby to the prevention of both pediatric obesity and type 2 diabetes.   "
143153|NCT01410630|"     A research study of a new method of visualizing internal organs called 18F-FLT PET/CT that     yields better tracking of cancer treatment progress. PET/CT stands for positron emission     tomography with low dose computed tomography and has been used for many years. 18F-FLT PET/CT     uses a new tracer, fluorothymidine, which is taken up by cells that are actively     proliferating or dividing such as cancer cells. We hope to learn whether this tracer is     superior to the conventional tracer for monitoring treatment of diffuse large B-cell lymphoma     (DLBCL).   "
143154|NCT01410617|"     Coronary artery disease is a major cause of death in patients with renal dysfunction Among     patients who undergo coronary artery bypass grafting ,renal dysfunction is known To be a     major predictor of in-hospital and remote mortality As little is known about the impact of     non-dialysis-dependent renal dysfunction on short and mid term Outcomes following coronary     surgery we have decided to investigate the effect of prophylactic Hemodialysis on the     mortality and morbidity of the patients with ckd (stage 3,4 ) and compare these Effect with     the control group   "
143155|NCT01410604|"     The purpose of this study is to compare serum concentrations of inflammatory cytokines,     interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour     necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese     adolescents with insulin resistance (IR).   "
143156|NCT01410591|"     The purpose of this study is to determine whether transjugular intrahepatic portosystemic     shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing     TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal     bleeding.   "
143168|NCT01410435|"     Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks     studies there is a need to follow-up on long term safety and efficacy of any maintenance iron     therapy.      This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron isomaltoside     1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000 (Monofer®) and its     ability to maintain stable haemoglobin in IBD subjects with Iron Deficiency Anaemia (IDA).   "
143157|NCT01410578|"     The investigators enrolled 144 subjects admitted to ICUs: 60 patients with systemic     inflammatory response syndrome (SIRS) and 84 patients with sepsis. Tests for serum sTREM-1,     PCT, and CRP levels and blood culture were performed on the day of admission and with the     occurrence of FUO (>38.3ºC) during hospitalization. Based on the results of blood culture,     the subjects were divided into bacteremia (33 patients) and non-bacteremia groups (51     patients). Based on 28-day survival, bacteremia patients were also divided into survivor (22     patients) and non-survivor groups (11 patients). Serum sTREM-1 and PCT levels were summarized     as medians (interquartile ranges) and CRP levels were presented as means ± standard     deviations. To explore the early diagnostic value of soluble triggering receptor expressed on     myeloid cells 1 (sTREM-1), procalcitonin (PCT), and C-reactive protein (CRP) serum levels for     identification of sepsis and bacteremia and the prognosis among patients with a fever of     unknown origin (FUO) in the intensive care unit (ICU) and to discuss the clinical application     of the results.   "
143158|NCT01410565|"     This is an international, multicenter, double-blind, placebo-controlled, randomized study.     All eligible patients entering the open label phase of the study will receive a single     immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral     resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double     Blind Phase qualification, patients with confirmed eligibility will be randomized to receive     either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo     cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients     with histologic evidence of recurrent disease during the study will be treated according to     current treatment guidelines or local standard of care. Safety and efficacy assessments will     be performed at 3 month intervals for all randomized patients throughout the study. Patients     who receive single dose of apaziquone immediately following TURBT and are not eligible for     randomization will be followed for 3 months by cystoscopic exam and safety assessments.   "
143159|NCT01410552|"     ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate     shocks, in a general population implanted for primary or secondary prevention with a dual or     tri chamber device at one year follow-up   "
143160|NCT01410539|"     This study is designed to assess the pathophysiology of ST by studying the main procedural     and anatomical factors involved in the genesis of ST such as those related to stent and the     vascular wall, as well as to the individual platelet residual reactivity.   "
143183|NCT01410240|"     The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of     care for hemostasis in subjects undergoing total knee arthroplasty.   "
143184|NCT01410227|"     The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF,     and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding     events in subjects with severe hereditary von Willebrand disease (VWD).   "
143161|NCT01410526|"     Protocol Synopsis      Protocol title: Assessment of peritoneal immune response in patients with severe     intra-abdominal sepsis managed by laparostomy and VAC      Purpose: Assessment of peritoneal immune response in patients with severe intra-abdominal     sepsis      Design: Prospective, single-center study      Patient Population: Male or female adults (>18 years) with severe intra-abdominal sepsis      No. of Subjects: 60 patients divided into two groups, 30 patients with severe intra-operative     sepsis and 30 patients without sepsis scheduled to undergo major abdominal operations (middle     line incision>15cm). The study is estimated up to 2 year to enroll      Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient     discharged or deceased.      Endpoints:        1. To measure the peritoneal cytokines levels in patients with severe intra-abdominal          sepsis.        2. To correlate the cytokines levels in the abdominal cavity and the serum plasma.        3. To correlate cytokines response in serum plasma and peritoneal fluid with mortality and          morbidity.        4. To compare cytokines results in serum plasma and peritoneal fluid between patients with          severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis.        5. To assess the microbial load in the abdominal cavity in patients with severe sepsis.        6. To assess the biofilm formation in VAC polyurethane sponge.   "
143162|NCT01410513|"     Primary Objective:      - To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for     SAR245409 when administered in combination with rituximab or bendamustine plus rituximab      Secondary Objectives:        -  To determine the safety and tolerability of SAR245409 in combination with rituximab or          bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL) Mantle          Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)        -  To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when          used in combination in subjects with iNHL, MCL or CLL        -  To determine the pharmacodynamic (PD) effects of SAR245409 in combination with rituximab          or bendamustine plus rituximab in subjects with iNHL, MCL or CLL        -  To determine the antitumor activity of SAR245409 in combination with rituximab or          bendamustine plus rituximab in subjects with iNHL, MCL or CLL   "
143163|NCT01410500|"     The purpose of this study is to expand upon the safety data for carfilzomib by providing     expanded access to patients with relapsed and refractory multiple myeloma who are unable to     enroll in any other ongoing carfilzomib trial.   "
143164|NCT01410487|"     Obesity is a medical problem of epidemic proportions and is associated with high mortality.     Obesity has significant effects on the cardiovascular system, producing structural     cardiovascular changes including myocardial hypertrophy, fatty infiltration, and fibrosis;     diastolic and systolic dysfunction; changes in pulmonary artery compliance; and increased     aortic stiffness - all of which can lead to heart failure. Indeed, evidence suggests that     obesity increases the risk for heart disease independent of other known risk factors such as     coronary artery disease, hypertension, diabetes mellitus, and obstructive sleep apnea.     Obesity also causes significant changes in pulmonary function, including a decrease in     expiratory reserve volume and functional residual capacity and closure of peripheral airways.     The exact mechanisms for the development of cardiopulmonary disease are not well understood -     the pathophysiology is complex and likely multifactorial, related to altered hemodynamic     load, altered metabolic activity, underlying inflammation, and increased cardiac output.      Newer diagnostic modalities available at our institution such as cardiac MRI and pulmonary     function tests with impulse oscillometry allow us to better evaluate cardiopulmonary     dysfunction in patients with severe obesity. Cardiac MRI is especially promising as a     non-invasive imaging modality in obese individuals, providing more reproducible measurements     of cardiac and vascular anatomy and function relative to echocardiography. Similarly,     pulmonary function testing with impulse oscillometry is more sensitive for detection of     abnormalities in the distal airways especially when spirometry is normal, as frequently     occurs in the severely obese symptomatic patients. The main objective of the proposed study     is to evaluate the effect of obesity on quality of life and health care utilization and its     relationship to cardiopulmonary disease in an ethnically diverse, underserved obese     population by using state-of-the-art diagnostic modalities before and after significant (20%)     weight loss.      The investigators propose to perform stress cardiac MRI and pulmonary function testing with     oscillometry before and after significant surgical weight loss in 150 severely obese patients     with cardiopulmonary symptoms. Patients evaluated in the comprehensive Obesity Center at     Bellevue Hospital who meet NIH Consensus Guidelines for Bariatric Surgery, who have     cardiopulmonary symptoms, and who meet clinical criteria for cardiac stress testing and     pulmonary function testing will be approached by the study personnel and offered enrollment.     Informed consent will be obtained. Enrolled patients will undergo clinical evaluation with a     detailed medical history including the Borg dyspnea scale, physical examination, laboratory     testing including cardiopulmonary biomarkers (brain natriuretic peptide, C-reactive protein,     atrial natriuretic peptide), and non-invasive cardiovascular stress MRI and pulmonary     physiologic evaluation including spirometry, plethysmography and impulse oscillometry (IOS).     Patients with active smoking history and/or asthma will be identified clinically.      Cardiovascular MRI will be performed using a 1.5T (Avanto or Espree, Siemens Healthcare)     system. Standard cardiovascular techniques will be used for the assessment of myocardial and     vascular structure and function, including T1-weighted, T2-weighted, late gadolinium     enhancement, cine, tagged and phase contrast imaging in selected planes. Adenosine stress MRI     will be performed for evaluation of underlying coronary artery or microvascular disease.   "
143165|NCT01410474|"     This study will evaluate the immunogenicity and safety of a single injection of Novartis     Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.   "
143166|NCT01410461|"     Study aims to: (1) evaluate the role of morphological and physiological characteristics of     the pelvic floor, pain-related psychological and -psychophysical variables in prediction of     the success of myofascial physical therapy (MPT) for the treatment of painful bladder     syndrome Patients with clinical symptoms of PBS will undergo physical examination, sensory     testing in the genital area, perineal ultrasound examination for the evaluation of the length     of the levator muscles before MPT and following 10 consecutive sessions of MPT.      Improvement in clinical symptoms will be assessed and evaluated for correlations with     psychophysical examinations.   "
143167|NCT01410448|"     The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant)     administration of everolimus after transplantation reduces the risk of wound healing     complications in comparison with immediate administration in de novo renal transplant     patients (proportion of patients without wound/surgical complications related to initial     transplant surgery) between randomization and 3 months after transplantation.   "
143224|NCT01409707|"     The purpose of this study is to test if provision of an effective psychotherapy for     Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol     dependent patients with PTSD and if it is associated with better treatment outcomes compared     to an active control condition.   "
143169|NCT01410422|"     Metabolomics is a large-scale approach to monitoring the compounds involved in cellular     processes. It may reflect changes in biological function. Collection of exhaled breath is a     newly developed, noninvasive method that may allow clinicians and researchers to assess     biochemical profiles in the airway. This study is conducted for the metabolomic analysis of     the exhaled gas in patients with Chronic Obstructive Pulmonary Disease (COPD) and     bronchiectasis.   "
143170|NCT01410409|"     The purpose of this study is to test whether surgical insertion of total knee replacement     provides further improvement in quality of life, pain and function in addition to an     algorithm for systematic non-surgical treatment consisting of corrective insoles,     neuromuscular training, weight loss, patient education and pharmacological treatment with     paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the     MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).      The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment     results in a greater increase in quality of life and functional capacity and greater     reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up     12months after the start of the treatment.      See statistical analysis plan available under Links for further description of the study.   "
143171|NCT01410396|"     The aim of this study is to determine the yield of 3 weeks outpatient mobile cardiac     monitoring for detection of atrial fibrillation in patients with history of stroke of known     cause.   "
143172|NCT01410383|"     Eprotirome is a liver selective thyroid hormone that can reduce several independent risk     factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic     tissue.      The purpose of this Phase III study is to assess the long-term efficacy and safety of     Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal     standard of care.   "
143173|NCT01410370|"     The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar     infusion combined with radiotherapy for treatment of brain metastases.   "
143174|NCT01410357|"     This project tests a model for improving illness self-management among persons who have both     serious mental illness and diabetes and will be performed within a primary care setting at a     safety net hospital system. The information gained from the randomized trial will be     supplemented with reports from participants about their experiences of trying to improve     illness self-management. Improvements in self-management should result in a reduction of     psychiatric symptoms and improvements in functioning and physical health.   "
143188|NCT01410175|"     Surgical site infection (SSI) is the second commonest hospital infection, despite advances in     prevention that have been achieved.      According to Fernàndes, experimental studies have demonstrated that incorrect use of electric     scalpels may double the rate of SSI during electrocauterization.      Because of the lack of solid data in the literature, in relation to the impact on SSI of     using electric scalpels for making incisions in the skin and all subcutaneous tissues, it was     judged to be opportune to conduct the present study.      Objectives:        -  To compare the incidence of SSI and other complications of the operative wound among          patients undergoing elective abdominal gynecological surgery at Barretos Cancer          Hospital, between the use of electric and cold scalpels.        -  To identify the incidence of SSI and other complications of the operative wound among          patients undergoing elective abdominal gynecological surgery, when using electric          scalpels for skin incisions and for subcutaneous incisions.        -  To identify the main risk factors for SSI among patients undergoing elective abdominal          gynecological surgery.   "
143189|NCT01410162|"     Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or     twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal     allograft function, other relevant biochemical parameters and treatment related adverse     effects.   "
143190|NCT01410149|"     Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of     polysomnography to record sleep patterns while receiving three modes of mechanical     ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV),     Assist control ventilation (ACV), applied in random order. The purpose is to determine the     effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.   "
143191|NCT01410136|"     The overall study objective is to evaluate Chondrofix Osteochondral Allograft (Chondrofix)     for the repair of osteochondral lesions in the knee. This includes, but is not limited to     primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The     study hypothesis is that Chondrofix Allograft will provide pain relief and functional     improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24     months of follow-up.   "
143192|NCT01410123|"     The study is a series of 3 linked randomized clinical trials of 6 month duration, with a     total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking     outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with     unhealthy alcohol use.   "
143193|NCT01410110|"     The initial phase of substance abuse treatment is a vulnerable period for relapse. Cognitive     impairments are common during this phase and may reduce the ability to benefit from other     forms of substance abuse and rehabilitation services. The study compares a rehabilitation     program that combines work therapy with computer-based cognitive training of attention,     memory and executive functions to work therapy alone in a 3 months outpatient substance abuse     program. It is hypothesized that cognitive training will increase days of sobriety during the     active intervention and better substance abuse outcomes at 6 month follow-up.   "
143194|NCT01410097|"     Obesity is associated with physical disability through both direct pathways (e.g., lower     extremity pain, insufficient muscle strength) and indirect pathways (obesity-related     comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health     condition, is associated with increased risk of disability and accelerated declines in     physical and cognitive function. The investigators preliminary data suggest that intentional     weight loss improves physical function, and there is strong circumstantial evidence that it     would also benefit cognitive function.      To evaluate the role of intentional weight loss on physical and cognitive function, the     investigators propose an ancillary study to the on-going Look AHEAD (Action for Health in     Diabetes) trial. Look AHEAD is a multi-center, randomized clinical trial to examine the     effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss     through decreased caloric intake and exercise in overweight or obese men and women aged 45-74     years with type 2 diabetes. The investigators propose to add validated and well-established     measures of physical and cognitive performance to the year 8 follow-up visit - during the     trial's weight maintenance phase - in ~1000 participants at 4 of the 16 Look AHEAD field     sites (Colorado, Memphis, Pennington and Pittsburgh).      The specific aims of this ancillary study are: 1) To determine the long-term effects of a     lifestyle intervention designed to achieve and maintain weight loss on physical function; and     2) To determine the long-term effects of a lifestyle intervention designed to achieve and     maintain weight loss on cognitive function. In addition, the investigators hypothesize that     in the intervention group, larger initial weight loss, better weight loss maintenance, and     higher physical activity will be associated with better physical and cognitive function. The     investigators also hypothesize that in the control group weight loss will be associated with     worse physical and cognitive function than in those who are weight stable or who have gained     weight.      The number of obese older adults is rising rapidly and there are few data to guide an     evidence-based clinical response to their management. The results of this study will provide     the first direct evidence of the role of long-term intentional weight loss on the maintenance     of physical and cognitive function in older obese adults with diabetes. Since this study is     being done as an ancillary study to an on-going trial it can be done in a timely and     cost-efficient manner.   "
143195|NCT01410084|"     In the past two decades, the role of vitamin D has extended beyond bone health to encompass a     wide range of biological activities important to physical function in older adults. A growing     body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels < 75 nmol/L     (< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and     impaired balance as well as falls. Older adults are at risk for low levels of     25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced     efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from     the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank     vitamin D deficiency (serum 25(OH)D < 25 nmol/L [10 ng/mL]) is rare in the U.S. (5% or less),     vitamin D insufficiency (serum 25(OH)D < 75 nmol/L [30 ng/mL]) is prevalent (~75%) among     older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor     dietary intake and nutritional health, nutrition-related health conditions, and functional     decline and disability. The primary goal of this pilot study is to assess the feasibility of     a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in     home-bound older adults receiving home-delivered meals. A secondary goal is to obtain     preliminary data on the effectiveness of vitamin D supplementation on improving vitamin D     levels and reducing falls.   "
143196|NCT01410071|"     The purpose of this research study is to see if there is a significant difference in     improvement of symptoms and quality of life of those undergoing endoscopic therapy versus     those wanting to control their symptoms with medicines or those who just want to wait and     watch.   "
143197|NCT01410058|"     A study will be conducted by scientists from the University of Zimbabwe to determine if     antiretroviral drugs are affected by taking herbs at the same time. This is important because     herbal medicines may interact with modern medicine to increase or decrease the amount of     medication in the body.      The drugs nevirapine and efavirenz will be studied. Both drugs are routinely used as part of     combination therapy for treating HIV. In this study it will be determined whether the     concentrations of the antiretroviral drugs nevirapine and efavirenz are low, high or are in     the desired range when taken together with the herb moringa.   "
143198|NCT01410045|"     Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular     apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation     has been used in an effort to preserve fertility in patients undergoing treatments which lead     to premature and severe ovarian insufficiency. This study aims to assess the relevance of     ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular     density as primary outcome and karyotypic, clinical and hormonal markers as secondary     outcomes, analysis of the study will allow to select the patients to whom the procedure would     benefit the most.   "
143199|NCT01410032|"     The purpose of this study is to compare the clinical and radiographic results of patients     with midshaft clavicular fractures treated with plates or intramedullary flexible nails     fixation.   "
143200|NCT01410019|"     X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in     failure of development of the immune system in boys. This trial aims to treat SCID-X1     patients using gene therapy to replace the defective gene.   "
143201|NCT01410006|"     The Neurofibromatosis Type 1 (NF1) Patient Registry Initiative (NPRI) is a web-based registry     that asks participants to fill out a 30-minute online questionnaire to collect information     about the spectrum of medical and social problems experienced by children and adults with     NF1. The information gained from your participation may one day help doctors develop     personalized treatments for individuals living with NF1.      We are currently enrolling individuals with NF1 who either (1) HAVE previously been diagnosed     with a brain tumor younger than 18 years or (2) HAVE NEVER had a brain tumor. Please note:     there is no therapy associated with this study. Individuals may participate in the registry     by going to https://nf1registry.wustl.edu/   "
143202|NCT01409993|"     The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on     glucose metabolism in persons with prediabetes.   "
143203|NCT01409980|"     A triphalangeal thumb is a thumb with three phalanges. The thumb often appears long and     fingerlike, and can sometimes be in the same plane as the other fingers. Anatomically, the     extra phalanx can have different shapes. Several classification systems have been used, but     the simplest and most often used is the Wood (1976) classification by the shape of the extra     phalanx. If the extra phalanx is triangularly shaped it is classified as a type I. Type II     has a rectangular shaped extra phalanx but it has not developed as a full phalanx. Type III     is a full extra phalanx.   "
143204|NCT01409967|"     The aim of this work is to study the changes of key assays useful for the understanding of     anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays,     hemolysis markers.   "
143205|NCT01409954|"     The purpose of this study is to improve fusion (bony healing) techniques and improve patient     recovery by identifying cells in your body that make bone. Patients with spine problems often     need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together     in order to hold the bones steady allowing them to heal together (fusion). If the vertebrae     (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a     slower recovery and may require revision (another) surgery. By using a small portion of the     graft taken during surgery the investigators hope to define the cells that make bone most     efficiently. This will help reduce the need for revision surgeries and improve patient     recovery.   "
143206|NCT01409941|"     Cerebral oxygen saturation (ScO2) is a measure of cerebral and systemic oxygen delivery to     demand ratio. An observational trial in a heterogeneous cohort of 1078 patients patients     revealed that a ScO2 below 50% absolute during oxygen insufflation is an independent     predictor of short and long term mortality in patients undergoing on-pump cardiac surgery.     Comparably, a low ScO2 was a predictor of postoperative morbidity determined as a combined     endpoint of a high dependency unit stay of more than 9 days and/or at least 2 of the major     postoperative complications. low cardiac output syndrome, stroke, need of renal replacement     therapy or reintubation.      The primary objectives of the present prospective observational study is to determine, if     there is an association between preoperative ScO2 and postoperative organ dysfunction     determined by sensitive markers of organ dysfunction (N-Terminal pro B-type natriuretic     peptide, high sensitive troponin T, growth-differentiation factor 15, soluble -FLT1, and     placental growth factor)   "
143207|NCT01409928|"     This is a prospective, non-randomized, single center study of a laparoscopically placed,     adjustable gastric band medical device for the treatment of adolescent obesity.   "
143208|NCT01409915|"     A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested     for its ability to be tolerated by Alzheimer's disease patients and potentially to improve     their memory.   "
143209|NCT01409902|"     The main objective of the study is to assess the effectiveness of the sheathed speculum in     providing adequate visualization and access to the cervix in patients with excessive vaginal     tissue.      The secondary objective is to rate the patient's comfort evaluation during the sheathed     speculum examination.   "
143210|NCT01409889|"     The purpose of this study is to compare the effectiveness and costs of two programs,the     Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in     an primary care practice.   "
143211|NCT01409876|"     This is a phase II trial looking at the feasibility of HistoScanning- based dose-painting     image- guided interstitial brachytherapy in non- metastatic prostate cancer      Endpoints:      Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image-     guided interstitial brachytherapy      Secondary endpoints        1. Evaluating tumor response using HistoScanning        2. Evaluating locoregional recurrence rates by measuring PSA        3. Analysis of the correlation between tumor response as determined by HistoScanning and          PSA response        4. Evaluating the safety dose-painting image- guided interstitial brachytherapy by          recording serious adverse events   "
143212|NCT01409863|"     The goals of this study will be to compare the safety and efficacy of fractional     photothermolysis (Fraxel) with dermabrasion when used for scar revision.   "
143241|NCT01409486|"     The aim of the study is:      to develop a comprehensive biochemical assay for detection of Pompe disease (glycogen storage     disease type II), to be implemented in the Newborn screening program among the Israeli     population.   "
143213|NCT01409850|"     The most commonly applied treatment against acute temporomandibular signs and symptoms is     pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like     splints) is very low. Two very commonly used splints are the Aqualizer® and the soft     polyester splint. These are splints applied for a short period of time, until the treatment     with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical     short-time efficacy of these two splints for the treatment of acute temporomandibular pain     and compare it to a control group receiving no therapy for that short time.      The study hypothesis is that there is a difference in pain reduction between the three groups     of patients (two intervention and one control group).   "
143214|NCT01409837|"     This study was conceived in order to explain what the investigators previously observed     suggesting that lisinopril, a drug normally used to treat patients with high blood pressure     and heart failure, may be effective in treating infertile men with low sperm count. The     investigators hypothesized, therefore, that the drug will not only improve sperm quantity and     quality but also increase the fertility in such patients. The investigators first of all     reviewed the results of previously published investigations and found out that there was only     a few previous studies done in humans.with this class of drugs. Besides, the methods used in     conducting most of those studies have been so faulted that the results cannot be trusted to     be showing the true picture. The investigators looked at the various faults pointed out with     respect to the their design and conduct and took care of them while designing the     investigators own study. This was an attempt to provide more credible answers to the question     of whether lisinopril, and possibly other drugs of similar mode of action, can be useful in     rectifying the problem of infertility caused by low sperm count and , if so, whether it will     be safe to use it in people who do not have high blood pressure or heart failure. In order to     achieve this the investigators studied 33 patients with sperm of low cell concentration, low     percentage of motile cells and high percentage of abnormal cells from no known cause. The     patients were randomly allocated to receive either lisinopril 2.5mg daily (17 patients) or     daily placebo (16 patients)and their sperm characteristics were examined at intervals,     starting from the beginning of the study until when it ended 282 weeks later. The patients     were also monitored for adverse events throughout the period. The data form all the patients     that took part in the random allocation of treatments at the beginning of the study were     included in the analysis that followed, irrespective of whether they completed the study or     not.   "
143215|NCT01409824|"     Besides a dramatic lack of financial and human resources in developing countries, health care     is additionally endangered by quality deficiencies caused by low staff motivation. This lack     of motivation leads to an insufficient translation of knowledge into optimal utilization of     resources. The know-do gap represents a challenge that must be addressed to strengthen     health services performance towards achieving the Millennium Development Goals (MDGs). This     is in particular true for some sensitive sectors like pre-natal and maternal health care.     General objective of this research is to improve maternal health through better pre-natal and     maternal care services offered by better motivated health workers. A computer-assisted     clinical decision support system (CDSS) will be developed, implemented and tested aiming at     (I) quality improvement of maternal and newborn care and (II) assessment of provider's     performance. Based on this tool a commonly agreed incentive scheme to increase motivation     will be shaped and tested in three SSA - countries, namely Burkina, Ghana, and Tanzania.      The incentive scheme might contain both non-monetary and monetary incentives and will be     designed according to the human resource policy in the three countries. The planned approach     is an implementation study with control arms containing one hospital and 6 first line health     facilities in each of the study districts and an equal number of facilities in the control     arm. A set of indicators for measurement of changes in quality of delivered services will be     identified in order to follow up the sustainability and effectiveness of the strategies after     their implementation. The study findings will allow understanding the important factors of     staff motivation and facilitate adequate management for improvement of maternal and neonatal     health care. Knowing is not enough, we must apply; Wanting to do, is not enough, we must do     it1      - J.W. v. Goethe   "
143216|NCT01409811|"     This pilot clinical trial studies biomarkers in tissue samples from patients with newly     diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue     in the laboratory from patients receiving ZA may help doctors learn more about the effects of     ZA on cells. It may also help doctors understand how well patients respond to treatment.   "
143217|NCT01409798|"     The purpose of this registry is to create a database that collects clinical data to improve     knowledge about primary hyperparathyroidism.   "
143218|NCT01409785|"     The goal of this study is to compare the LMA Unique and LMA Supreme in children having     surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior     to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure     at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view,     feasibility of use, and complications (airway related, gastric insufflation, trauma) will     also be assessed.   "
143219|NCT01409772|"     The purpose of this study is to evaluate the clinical practice of the prophylactic use of     ethanol locks for the prevention of catheter related blood stream infections in pediatric     intestinal rehabilitation program patients requiring total parenteral nutrition.   "
143220|NCT01409759|"     Objective: to evaluate the perforator based interposition plasty in comparison to the     standard technique (full thickness graft) for scar contracture releases.      Study design: A randomised controlled multicentre intervention study.      Study population: Patients, aged 18 years and older, who require surgery for release of a     scar contracture, are eligible for this study. In total 50 patients will be recruited with a     follow-up of 3 months post-operatively.      Intervention: A release of the contracture will be performed in combination with òr the     standard technique (full thickness graft) òr the perforator based interposition plasty.      Main study parameters/endpoints: the main study parameter is the amount of contraction of the     flap/graft after three months.   "
143221|NCT01409746|"     The purpose of this study is to study the role of genes and environment in early brain     development using a twin approach. The investigators will use magnetic resonance imaging     (MRI) to study brain structure and it's relationship to cognitive development. Specifically,     the investigators will study cortical gray and white matter volumes, volumes of subcortical     structures and cerebellum, as well as diffusion properties in major white matter tracts using     DTI tractography.   "
143222|NCT01409733|"     The Aim is to evaluate safety and efficacy of TACE with doxorubicin-loaded DC beads in     melanoma patients with liver metastasis. This is a pilot study with the aim of recruiting 20     patients, this is a feasibility study. the patients profile is patients with stage IV     Melanoma with liver metastases.   "
143223|NCT01409720|"     Standard indications for palliative radiation of bony metastases include pain, spinal cord     compression, and impending pathologic fractures.      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid     complications. Tailored training of the paravertebral musculature may support radiation     therapy and improve above named factors. DISPO was designed to investigate the impact of     tailored physical exercise in patients with vertebral metastases as compared to manual     therapy (massage etc.). The trial includes patients with painful bony metastases, patients     with spinal cord compression or impending pathological fractures are excluded. The     investigations are carried out in a prospective randomized controlled phase-II parallel group     design.   "
143226|NCT01409681|"     Vitamin D exerts antiproliferative and differentiating effects in cancers, including     non-small cell lung cancer (NSCLC). The active form of Vitamin D is 1,25,     dihydroxycholecalciferol (calcitriol) which rapidly induces expression of cytochrome P450     24R-hydroxylase (CYP24A1). CYP24A1 initiates inactivation of calcitriol as a result of     successive hydroxylation/oxidation reactions. This study seeks to prospectively determine the     relationship between Vitamin D gene expression and median survival as a primary outcome, and     between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking     status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.   "
143227|NCT01409668|"     This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing     yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as     gastrointestinal microflora distribution in hyperlipidemic individuals.   "
143228|NCT01409655|"     Our proposal Centralized Off-Site Adherence Enhancement Program or CARE will develop and     test an effective behavioral adherence intervention program for HIV patients with alcohol     and/or substance abuse problems. This project will develop and pilot test a novel program to     help patients with alcohol and/or substance abuse problems take their medications as     prescribed. The intervention will be delivered by phone, and utilize electronic monitoring of     medication-taking, so patients can be treated by therapists from any geographic distance. To     safely monitor data collected for this study, we have laid out a detailed Data Safety     Monitoring Plan, which will cover all the issues required by NIDA.   "
143229|NCT01409642|"     Pediatric obsessive compulsive disorder (OCD) is a chronic, impairing condition that accrues     significant concurrent and long-term risk to affected youth (Piacentini et al. 2003; Pine et     al. 1998). Although a host of pharmacological and psychosocial treatments have proliferated     over the past decade (Barrett et al., 2008), many youth fail torespond to treatment and many     who do respond continue to exhibit lingering symptoms and impairment. Thus, there is still     much to be done by way of optimizing treatment outcomes for pediatric OCD.      Increasingly, efforts to improve existing treatments have focused on aspects of the family     environment that may affect treatment adherence and the maintenance of therapeutic gains.     Such work suggests that parental accommodation and criticism are common characteristics of     the home environment for both adults and children with OCD (Calvocoressi et al., 1999; Peris,     Roblek, Langley, Chang, McCracken, & Piacentini, 2008; Van Noppen et al., 1991) and that, in     adult samples, these family features are associated with poorer treatment outcome and greater     risk of relapse (Amir, Freshman, & Foa, 2000; Chambless & Steketee, 1999;Leonard et al.,     1993). These family-level variables are logical targets for intervention, particularly among     treatment refractory groups of youth with OCD. However, they often are unaddressed in extant     interventions.      The current study tests a novel intervention that specifically targets family accommodation     and conflict in an effort to foster an environment that supports a graded exposure approach     to treatment. The proposed treatment, Positive Family Interaction Therapy (PFIT), is composed     of an innovative blend of techniques that address several potential barriers to treatment.     First, the treatment is guided by the specific needs of youth with OCD and their families     (e.g., accommodation, conflict). The first phase of the proposed study will involve an open     case series in order to assess the utility of the PFIT protocol and feasibility of training     other therapists and using the manual with a range of patient presentations. The second phase     will involve a small controlled feasibility trial evaluating the extent to which recruitment,     randomization, and implementation of the control condition are viable for further study. It     is hypothesized that the PFIT treatment will be feasible to implement and will yield higher     levels of patient satisfaction compared to treatment as usual.   "
143230|NCT01409629|"     Study of activity choices after playing a computer game.   "
143231|NCT01409616|"     The primary objective of this study is to evaluate whether ASA, the combination of ASA and     clopidogrel, and darexaban, which have different effects on blood coagulation, influence each     other in their effects. Also it will be investigated whether the blood levels of either drug     are influenced by the presence of the other drug. In addition, the safety and tolerability of     each drug and the combination of the drugs will be investigated.   "
143232|NCT01409603|"     The primary objective of this study is to evaluate whether naproxen and darexaban which have     different effects on blood coagulation influence each other in their effects. Also it will be     investigated whether the blood levels of either drug are influenced by the presence of the     other drug. In addition, the safety and tolerability of each drug and the combination of the     drugs will be investigated.   "
143233|NCT01409590|"     In this study the investigators will recruit patients with the diagnosis of schizophrenia     that are taking atypical neuroleptics and that are willing to participate in an exercise and     diet program. The investigators will measure weight and abdomen circumference.   "
143234|NCT01409577|"     The investigator will evaluate the clinical outcomes of the patients in whom the treatment     strategy for their coronary stenosis were determined by fractional flow reserve measurement.   "
143235|NCT01409564|"     The purpose of this study is to examine the effects of cilostazol augmentation in mild to     moderate Alzheimer disease patients with subcortical white matter hyperintensities (WMHI)     treated by donepezil.      Dementia is the most disabling disease in the old age. The prevalence of dementia is 5-10% of     the elders. AchEIs (donepezil, galantamine, rivastigmine) are used to treat mild to moderate     dementia, but these drugs only relate to symptomatic improvement and the response rates are     less than 30%.      Cilostazol is a cyclic adenosine monophosphate phosphodiesterase 3 inhibitor (PDE3I) and used     as antiplatelet agent in subcortical vascular disease (WMHI). And it upregulates     phosphorylation of cyclic adenosine monophosphate-pathway response element binding protein     (CREB) which plays a crucial role in memory enhancement and synaptic plasticity related to     neurodegeneration prevention.      The investigators will try cilostazol augmentation in dementia patients with WMHI receiving     donepezil to see the addictive effects of cilostazol using cognitive tasks and PET imaging.   "
143236|NCT01409551|"     Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural     effusions, in terms of safety and efficacy.   "
143237|NCT01409538|"     This study examines the brain activation associated with placebo pain reduction.   "
143238|NCT01409525|"     The purpose of this observational, exploratory study in patients undergoing any cardiac valve     replacement or repair is to assess the rate of bacterial colonization over native     degenerative calcified cardiac valves.   "
143239|NCT01409512|"     The aim of the study is to evaluate changes in autonomic nervous system following treatment     with anticholinergic medication for OAB symptoms.      Heart variability as a measure of the functioning of the autonomic nervous system will be     recorded before and three months following treatment with solifenacin succinate 10 mg daily.   "
143240|NCT01409499|"     The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and     its efficacy is limited. More active treatments were performed in patients with advanced HCC     in China, which include radical hepatectomy or TACE. The study is to investigate whether the     active treatment will profit survival of patients, and to evaluate the safety.   "
143242|NCT01409473|"     The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT)     with simultaneous boost (higher radiation dose) to areas within the prostate with more     prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated     radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with     low- and intermediate-risk localized prostate cancer.   "
143243|NCT01409460|"     The purpose of this study is to evaluate how many patients require the addition of the     obturator nerve block in the recovery room after the total knee surgery. Also to study the     efficacy of blocking the obturator nerve in controlling their knee pain.   "
143244|NCT01409447|"     Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently     used to treat cartilage defects. The investigators had previously developed a biphasic     osteochondral composite as the construct for chondrocyte implantation. The investigators     further conducted this feasibility study of such device to treat patients with osteochondral     lesion of the knee joints.   "
143245|NCT01409434|"     This is a research study of the long term effects on blood sugar and cholesterol of blood     pressure lowering medications. People are invited to participate in this research study if     they participated in the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR 1,     NCT00246519 or PEAR 2, NCT01203852) study and are still taking a thiazide diuretic. In PEAR,     the effects on blood pressure, blood sugar, and cholesterol of the high blood pressure drugs     hydrochlorothiazide and atenolol over an 18 week period were evaluated. This PEAR follow-up     study will determine the effects of thiazide diuretics on blood sugar and cholesterol, but in     the period since the PEAR trial. The study hypothesis is that long term exposure to thiazide     diuretics results in larger increases in blood sugar and cholesterol levels than short term     exposure.   "
143246|NCT01409421|"     The investigators are studying motivational interviewing (MI). MI is a counseling method to     help people adopt healthy behaviors. The investigators will test whether MI improves     patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff     called glaucoma educators to use MI. Up to 250 patients at 3 clinics will be recruited. All     patients will receive their usual eye care. Based on chance, some patients will also be     supported by a glaucoma educator. The groups will be compared on medication adherence using     micro-electro-mechanical system(MEMS). MEMS are electronic bottle caps that track when a     medication bottle is opened. Patients will be aware that their medication use is tracked. The     groups will also be compared on treatment value, outcomes, and cost. The investigators will     also collect data on variables that may predict medication adherence.   "
143247|NCT01409408|"     Assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and     compare theses effects and renin activity and concentration to those obtained with a calcium     channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not     controlled by 100 mg per day of losartan.   "
143248|NCT01409395|"     This study will address the following question: Does nizatidine affect the pharmacokinetics     of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated     that nizatidine may block metformin elimination from the kidney by inhibiting organic cation     transporter efflux of metformin. The investigators hypothesize that the co-administration of     metformin and nizatidine will reduce the renal clearance (CLR) of metformin leading to     increased plasma concentrations and potential risk for toxicities. Knowledge of the     pharmacokinetic interaction profile of metformin with organic transporter inhibitors, such as     nizatidine, is important to help develop safer more effective drug therapy with reduced side     effects.   "
143249|NCT01409382|"     tPA has a pivotal role in placentation, mediationg activation of growth factors, such as     vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of     extracellular matrix and basement membrane (directly or through activation of matrix     metalloproteinases) and formation of hemidesmosomes.      A high-carbohydrate intake combined with lack of physical activity provides a strong stimulus     for maternal insulin production. In this scenario, either β-cells are dysfunctional and     diabetes supervenes, or excessive amounts of insulin are produced, providing pathological     stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor, PAI-1 excess may     affect placentation, increasing the risk of first trimester losses, preterm deliveries and     intrauterine growth restriction.      Our hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a     parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of     insulin.   "
143250|NCT01409369|"     This open-label, two period crossover study will evaluate the effect of multiple doses of     activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy     volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated     by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with     the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period     2, only a single dose of RO4995819 but no activated charcoal will be administered.   "
143251|NCT01409356|"     Overweight/obesity is increasing both in the general population and in patients with     cirrhosis. In compensated patients with cirrhosis increased BMI is a risk factor for clinical     decompensation independent of liver function and portal pressure. Nonetheless, patients with     cirrhosis and obesity show a progressive increase in portal pressure, which might explain     their increased risk of complications. Since obesity is a potentially modifiable risk factor,     we designed this proof-of-concept study to assess the effects of weight loss (obtained by 4     months of diet and exercise) on portal pressure in patients with compensated cirrhosis and     overweight/obesity.   "
143252|NCT01409343|"     This is a prospective, open label, multicenter study evaluating the safety, tolerability and     pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive     cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour     response will also be evaluated.   "
143253|NCT01409330|"     Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2     diabetes.      This study aims to explore the effect of diet lacking red meat, but containing increased     fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.   "
144017|NCT01399333|"     The purpose of this research study is to compare the varying qualities of protein supplements     utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) method and evaluating     the clinical outcome related to protein stores and absorption.   "
143254|NCT01409317|"     Standard high frequency repetitive transcranial magnetic stimulation (HF-TMS) is a     noninvasive method to activate or de-activate neurons in superficial regions of the brain     through the induction of weak electric currents in the brain tissue produced by rapidly     changing magnetic fields. Studies have generally shown standard HF-TMS to be effective in     treating major depressive disorder (MDD), although treatment effects are often highly     variable and there are several negative trials in the specialized literature. One reason for     these discrepant results might be that standard HF-TMS only enables direct stimulation of     superficial brain areas and, consequently, it is possible that the stimulation of deeper and     more widespread brain regions could produce superior and more reliable results. Recently, a     novel form of HF-rTMS (called deep transcranial magnetic stimulation or DTMS), that allows     direct stimulation of much larger and deeper brain regions, has also been shown to be     effective and safe in treating MDD. Neuroimaging studies have shown that standard HF-rTMS     directly affects several superficial areas of the brain, but to date there is no data on the     brain effects of DTMS. Thus, this study aims to explore, for the first time, the brain     effects of DTMS in MDD. More specifically, we, the investigators, hope to identify possible     neural predictors of clinical improvement after DTMS and also clarify the impact of DTMS in     the brain activity over time. In this study, DTMS will be applied over the left side of the     front of the head (a region known as the 'prefrontal cortex'), and will be compared with     standard HF-TMS in terms of its effectiveness and brain effects. For this, subjects with at     least moderate MDD will be randomized to receive daily DTMS or standard HF-rTMS treatment for     4 weeks, and will undergo functional magnetic resonance imaging (fMRI) before and after     treatment. fMRI is a neuroimaging technique that allows us to measure which areas of the     brain are more or less 'active' in response to specific stimuli at a particular time. During     the fMRI sessions, we will use a validated cognitive task on working memory. Our results     could eventually lead us, among other things, to identify which depressed patients would be     best candidates for receiving either standard HF-rTMS or DTMS, and which areas of the brain     should be targeted by these neuromodulation techniques.   "
143255|NCT01409304|"     We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel brain     stimulation technique, is effective for treating major depression. We hypothesize that 4     weeks of DTMS will be associated with significant improvements in depressive and anxious     symptoms without significant side effects.   "
143256|NCT01409291|"     Many Americans are living paycheck to paycheck. This may lead to financial stress and an     increase in overall stress. People under stress are more likely to smoke, consume alcohol,     eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also     increase the risk for heart disease. The purpose of this research study is to test whether     participating in the Financial Success Program improves health outcomes, in both the women     participating and their children.   "
143257|NCT01409278|"     The purpose of this study is to examine three different ways to control pain after hip     replacement:        1. One time injection of ropivacaine before wound closure        2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine          via catheter for 48 hours        3. Standard practice of patient controlled pump   "
143258|NCT01409265|"     The perceptual change on stroke patients during the movement recovery and its relationship     with social participation still remain unclear. The purposes of this study are: 1) to observe     the progression of perception deficit and 2) to understand the relationships among perception     deficit and other functional indicators.      A total of 90 stroke patients will be recruited. Each patient will receive three times     evaluation, including perception tests, motor function test, daily living ability tests and     social leisure participation questionnaires.   "
143259|NCT01409252|"     The investigators retrospectively reviewed all patients with neurosurgical operations for     hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then     telephoned the survivors for neurological and cognitive status.   "
143260|NCT01409239|"     Glycemic variability has been associated with mortality in hospitalized patients with     hyperglycemia. However, it is unknown how modulation of glycemic variability would impact     outcomes. One possibility is that glycemic variability could impact autonomic tone. In     particular, heart rate variability (HRV) measurement is a sensitive marker for measuring     autonomic tone, and aberrations in HRV have been associated with mortality. The current     randomized pilot study will compare the effects of continuous intravenous (IV) insulin and     subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized     non-critically ill patients with diabetes. Non-critically ill patients who are hyperglycemic     or are requiring at least 20 units of insulin per day will be included. Patients with     conditions that preclude accurate HRV readings (such as atrial fibrillation or paced rhythms)     will be excluded. Patients randomized to intravenous insulin will receive the therapy for 24     hours according to our standard hospital guideline. Patients randomized to subcutaneous (SQ)     insulin will receive basal bolus therapy using insulin analogues. All therapies will begin     between 8 and 10 AM. Patients will undergo repeated heart rate variability recordings during     the 24 hour period. Blood draws will be collected at baseline and at 24 hours for measurement     of catecholamines, insulin, and c-peptide. Glycemic variability will be measured using a     continuous subcutaneous glucose monitor and reported as coefficient of variation. The primary     outcome measure is low frequency-to-high frequency power spectrum ratio of heart rate     variability.        1. Glycemic variability is associated with unfavorable changes in autonomic tone, as          assessed by low frequency (LF)/high frequency (HF) HRV ratio, independent of changes in          overall glycemia.        2. Short-term increases in glycemic variability, followed by more prolonged glycemic          stability are observed in generalized hospitalized patients treated with intravenous          insulin compared to standardized basal bolus therapy. LF/HF HRV differs among subjects          receiving intravenous compared to subcutaneous insulin.        3. Glycemic variability differs among subjects receiving intravenous compared to          subcutaneous insulin   "
143261|NCT01409226|"     This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve     in diagnosing breast cancer in women with high-risk of breast cancer.   "
143262|NCT01409213|"     The purpose of this study is to collect information of the risk profile of patients with type     2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of     diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13,     2008   "
143263|NCT01409200|"     The goal of this clinical research study is learn if adding axitinib to hormonal therapy can     help to control prostate cancer when given before surgery. The safety of this drug will also     be studied.   "
143264|NCT01409187|"     The goal of the Phase I part of this clinical research study is to find the highest tolerable     dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A (interferon     alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma. The safety     of this combination will also be studied in Phase I. The goal of Phase II is to learn if this     combination can help to control metastatic melanoma.      Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells     that decrease the immune system's ability to fight cancer.   "
143265|NCT01409174|"     The goal of the Phase I part of this clinical research study is to find the highest tolerable     dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide),     Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to     patients with metastatic melanoma. The safety of this combination will also be studied in     Phase I. The goal of Phase II is to learn if this combination can help to control metastatic     melanoma. Note: The study was closed following Phase I enrollment.      Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells     that decrease the immune system's ability to fight cancer.      Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of     cells). This may stop the cancer cells from dividing into new cells.      Cisplatin is designed to poison the cancer cells, which may cause them to die.   "
143266|NCT01409161|"     The goal of this clinical research study is to learn if the combination of all-trans retinoic     acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to control acute     promyelocytic leukemia (APL). The safety of this drug combination will also be studied.      This is an investigational study. ATRA and ATO are FDA approved and commercially available.     GO is not FDA approved or commercially available. At this time, it is being used for research     purposes only.      Up to 100 patients will take part in the study. All will be enrolled at MD Anderson.   "
143267|NCT01409148|"     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive     monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT     imaging in patients with AL amyloidosis.   "
143268|NCT01409135|"     A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in     subjects with malignant solid tumors that express Nectin-4.   "
143269|NCT01409122|"     This is a four-part study of the safety, tolerability, and PK profile of sodium nitrite     inhalation solution (AIR001) of ascending multiple doses (Part A) and of escalating doses     with steady-state sildenafil (Part B) to healthy male and female subjects, as well as     assessment of the safety and tolerability of multiple doses of AIR001 to patients with     pulmonary arterial hypertension (part C) with a single dose PK study of AIR001 utilizing     three different nebulizers (Part D).   "
143270|NCT01409109|"     Several observations have been made with magnetic resonance imaging (MRI) that characterize     brain connections and brain function in individuals with schizophrenia and other mental     disorders. For example, research investigating schizophrenia focuses on the dysfunction of     connections within and between the medial temporal lobe and the prefrontal cortex as well as     other pertinent brain regions. This database registry will allow for the collection of     clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and     functional magnetic resonance imaging (fMRI) data on individuals with and without mental     disorders to better understand how connections in the brain and various brain regions     function differently while volunteers perform various cognitive tasks. This is an     observational study that is being conducted to collect data and place it in a registry for     current and future investigational questions related to imaging in mental disorders.   "
143271|NCT01409096|"     Primary purpose of this study is to determine if pregnenolone supplementation is associated     with greater improvement in depressive symptoms of patients with bipolar disorder. Also the     study will explore possibilities of improving anxiety and manic symptoms as well as the     patient's cognition.   "
143272|NCT01409083|"     Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The     increase in carbon dioxide production can be detected by measuring the exhaled carbon dioxide     in the lungs.      This study is conducted to access the clinical application of measuring exhaled carbon     dioxide to verify the correct position of intravenous catheters.Once the catheter is in the     correct position the injected bicarbonate will be detected as a distinct elevation of exhaled     carbon dioxide. A similar study was already performed in adults and was found useful. The     investigators now extend the clinical application to children.   "
143273|NCT01409070|"     In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have     been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been     evaluated the head to head comparison of two drugs. This study is a retrospective study to     compare the efficacy of two drugs.   "
143274|NCT01409057|"     Since selenium has demonstrated significant characteristics for a series of biochemical     processes, for antioxidant activity and immune stimulation, this observational study should     represent the effect of heart-lung-machine on selenium status of cardiac surgical patients     undergoing coronary bypass surgery. It will be examined in (approximately 100) adult     patients, under which 50 patients are operated conventionally (meaning with the use of     heart-lung-machine). Another 50 patients are operated on beating heart without the use of     heart-lung-machine (OPCAB = off pump coronary artery bypass). The allocation of individual     patients in these two groups is done according to clinical criteria and is undertaken by the     operating surgeon.   "
143275|NCT01409044|"     Background:      - Studies have shown that listening to music can decrease pain and anxiety. Following     surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and     anxiety. But these drugs can cause side effects such as low blood pressure and confusion. If     listening to music can help lower pain and anxiety levels, less medication might be needed     and these side effects could be avoided.      Objectives:      - To determine the effects of music on patient pain and anxiety in the first few days after     surgery.      Eligibility:      - Individuals at least 18 years of age who are scheduled to have surgery that requires a     24-48-hour stay in intensive care afterward.      Design:        -  All participants will be screened with a medical history before having surgery.        -  Participants will be divided into two groups: one group will listen to music after          surgery, and the other will not.        -  Before surgery, participants will answer questions about their pain and anxiety levels.          They will also be shown how to control the device that lets them administer their own          pain medication after surgery.        -  Following surgery, all participants will be transferred to the ICU and will answer the          same questions about pain and anxiety levels.        -  The music group will listen to a specially created CD of instrumental music for about 50          minutes, four times a day. The standard group will not listen to this music. All other          treatments will be the same in both groups. Both groups will continue to answer the same          questions about pain and anxiety levels.        -  Participants will have a final 15- to 20-minute interview after leaving the ICU. They          will answer questions about the ICU stay and (for those in the music listening group)          the music.   "
143276|NCT01409031|"     The purpose of this study is to determine whether intravenous sildenafil reduces pulmonary     artery pressure and improves oxygenation in near-term and term infants with persistent     pulmonary hypertension.   "
143277|NCT01409018|"     This study investigated repeated-dose pharmacokinetics and safety of itraconazole and its     active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the     development of invasive fungal disease.   "
143694|NCT01402518|"     This is a prospective chart review/data collection study of the per oral endoscopic myotomy     (POEM) procedure, that will include questionnaires administered throughout the study.     Subjects enrolled will be those intending to have a POEM procedure. Data will be collected     and reviewed through 12 months post-op.   "
143278|NCT01409005|"     Although there have been remarkable advances in the treatment of metastatic or recurrent     colorectal cancer (MRCRC), long term survival cannot be expected in most patients with MRCRC     because of inevitably developing resistance to chemotherapeutic drugs except some MRCRC     patients who can undergo complete resection (metastasectomy). Until now, approved cytotoxic     drugs for treatment of MCRC are only 3 categories (fluoropyrimidine, oxaliplatin and     irinotecan). Recently, molecularly targeted drugs are approved for MRCRC patients, and     bevacizumab and cetuximab (for K-ras wild type tumors) are available. When cytotoxic and     targeted drugs are appropriately combined, about 24 months of overall survival (OS) can be     expected in patients with MRCRC. However, when these drugs are all used or patients cannot     afford to receive expensive targeted drugs because of economical problems, there is no option     for chemotherapy and best supportive care is the only option, although some patients still     have good performance status and medical conditions. Therefore, there are unmet needs for     additional salvage chemotherapy regimens for patients with oxaliplatin, irinotecan and     fluoropyrimidine-refractory MRCRC.      In some previous studies, gemcitabine-based chemotherapy showed some antitumor activities in     MRCRC patients. Especially, when combined with fluoropyrimidine, gemcitabine has been shown     to exert synergic effects on antitumor activities. On these backgrounds, this phase 2     clinical study was designed. In this study, efficacy and safety of gemcitabine plus UFTE     chemotherapy will be evaluated in MRCRC patients.   "
143279|NCT01408992|"     This study is aimed to test the sensitivity and specificity of Thai-version Five Minutes     Hearing test against the audiometry to screen hearing problem in community.   "
143280|NCT01408979|"     Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal     duration of this treatment after delivery is still to be established. The hypothesis is that     in stable patients a shorter course of treatment is possible without prejudice to the mother.   "
143281|NCT01408966|"     This study was aimed at testing the hypothesis that supplementing a meal with dark chocolate,     which holds potent antioxidant properties, might attenuate the postprandial increase in the     hepatic venous pressure gradient (HVPG, clinical equivalent of portal pressure) in patients     with cirrhosis   "
143282|NCT01408953|"     Keloid is chronic skin conditions that results in formation of tumor like growths on the     skin. Despite its benign nature, keloid can cause severe aesthetic and, in some cases,     functional problem which negatively impacts person's quality of life.      Keloids do not regress on their own and results of most available treatments such as surgery,     injecting keloids with steroids, chemotherapy injections, or even radiation therapy, have     mostly proven disappointing.      Some laboratory studies have shown that there is excessive amount of a protein called     vascular endothelial growth factor (VEGF) in keloid tissue. This may play role in the     formation and evolution of keloid.      Bevacizumab is a drug that works by targeting vascular endothelial growth factor (VEGF) which     helps new blood vessels form. Without new blood vessels, the growth of the keloid may be     slowed      Based on presence of excess amount of VEGF in keloid tissue, we hypothesize that bevacizumab     will be effective in treatment of keloids. This exploratory clinical trial is to confirm or     reject this hypothesis.   "
143283|NCT01408927|"     The primary objective of this prospective clinical registry is to determine the prevalence     and level of thienopyridine resistance seen in a population undergoing contemporary     percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).   "
143284|NCT01408914|"     The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to     shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses     are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood     concentrations will result in tuberculosis bugs being killed more quickly; and, both of these     will happen without more adverse events. Patients with active, infectious, drug-susceptible     TB who agree to participate will be randomly assigned to 1 of 3 doses of RIF. All patients     will also receive standard doses of regular (3) companion drugs for 2 months of daily,     supervised therapy. The study will assess the following among the 3 study arms (oral doses of     RIF 10, 15 & 20 mg/kg/day) during the initial 8 weeks of treatment: 1) the amount of RIF in     the blood after at least 14 days of treatment; 2) the difference in the number of     tuberculosis bugs killed; 3) the frequency of adverse events.   "
143285|NCT01408901|"     The PROPEL study will test the hypothesis that GM-CSF combined with supervised treadmill     exercise will significantly improve functional performance in patients with PAD more than     GM-CSF alone or supervised treadmill exercise alone. In addition to identifying novel     therapeutic options for patients with PAD, the current proposal is expected to identify     mechanisms by which functional impairment is improved in patients with PAD.   "
143286|NCT01408888|"     The purpose of this study is to study the effect of LY2189265 on how the body absorbs and     processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects     LY2189265 when they are taken together.      The duration of participation in this study is expected to be approximately 61 days. The     study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).      The study involves 3 injections, subcutaneous, of 1.5 milligrams (mg) LY2189265 and 18 daily     doses of 100 mg sitagliptin tablets administered orally.   "
143287|NCT01408875|"     The purpose of this study is to determine if addition of low frequency     electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity     and/or muscular strength in chronic heart failure patients.   "
143305|NCT01408641|"     Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder     (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more     difficult than treating AUDs in the general population. The FDA-approved medication     topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has     also improved symptoms in people with PTSD. This study is designed to investigate whether     topiramate will improve drinking outcomes in Veterans with PTSD.   "
143306|NCT01408628|"     The primary purpose of the study is demonstration that teaching insulin management in small     groups of type 2 diabetes patients in 4 weekly live Internet sessions is safe and provides     an important resource for rural diabetes care providers who may otherwise, because of lack of     time or staff, not be able to put patients on insulin who need it.   "
143288|NCT01408862|"     Novel drugs for the treatment of patients with diabetes are of interest for cardiologists if     they reduce the risk of cardiovascular events. However, as documented by the current     discussion about the potential benefits of glitazones, high hopes can fail. Initial     beneficial cardiovascular effects shown in proof-of-concept studies were muted by the     apparent higher mortality in the metaanalysis of studies with rosiglitazone. The rapidly     increasing use of GLP-1 analogues and DPP-4 (Dipeptidyl protease 4) inhibitors for the     treatment of type 2 diabetes mellitus may be of major interest for the cardiologist.     Potential beneficial actions on the cardiovascular system so far shown in animal experiments     and small proof of concept studies may provide the rationale for using these drugs     specifically in diabetic patients with secondary complications such as macrovascular disease     or diabetic cardiomyopathy. Theoretically, these new therapies could also proof beneficial in     patients with heart failure, independently of concomitant diabetes mellitus. However, many     unanswered questions need to be addressed in the near future to extend the experimental     findings to potential benefits of real life patients. In summary a new class of antidiabetic     drugs, which could possibly directly influence cardiovascular effects of diabetes mellitus     and thus possibly treat or even prevent life threatening complications has become available.      Then our working hypothesis was that incretins may have desirable cardiovascular outcomes     through modulating platelet function. In order to test this hypothesis we propose to assess     the presence of their specific receptors in isolated human platelets. In addition, we     proposed to sudy the effect of the endogenous incretins (glucagon-like peptide 1 and gastric     inhibitory peptide) on human platelet function isolated in a test tube.   "
143289|NCT01408849|"     This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia     Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA     score, secondary endpoint is endoscopic classification (Sydney).   "
143290|NCT01408836|"     The purpose of this study is to test whether additional therapy with plasma exchange improves     the chances of kidney recovery in severe kidney vasculitis.   "
143291|NCT01408823|"     This study will evaluate the pharmacokinetics of antifibrinolytic drug epsilon-aminocaproic     acid (EACA) in children undergoing Posterior spinal fusion surgery (PSF) at The Children's     Hospital of Philadelphia (CHOP) who receive EACA at the standard dose reported in the     literature for this population and currently in use at CHOP.   "
143292|NCT01408810|"     The aim of this study is to assess the relationship between microscopic Geboes index of     inflammation and clinical course of ulcerative colitis in patients treated with infliximab.     The investigators propose to test the hypothesis if infliximab is able to induce histological     remission and then change the clinical course of ulcerative colitis.   "
143293|NCT01408797|"     The objective of this trial is to determine if clonal deletion before kidney transplantation     can effectively reduce the need for post transplant immunosuppression. The investigators will     adapt a DAWN (Drugs (immunosuppressants) Added When Needed) treatment protocol to assess the     effect of clonal deletion and closely monitor acute rejection, renal function, and graft     survival. 15 patients eligible for the study as described below will be enrolled.   "
143294|NCT01408784|"     The purpose of this study is to assess the validity of self-caloric evaluation, the     categories method - a new method based on one categorical score per meal   "
143295|NCT01408771|"     The purpose of this study is to find out whether swallowing has an effect on the degree of     urinary urgency and on the amplitude of detrusor contraction during filling cystometry in     patients with detrusor overactivity (DO).   "
143296|NCT01408758|"     The Virtual Clinician Research Tool (VCRT) will use a virtual format to present our National     Cholesterol Education Program (Brown, 2004) and the Tobacco Use and Dependence Treatment     Clinical Guideline (Fiore et al., 2008) integrated with principles of human motivation from     Self-Determination Theory (SDT) for patients with elevated risk for cardiovascular disease     from LDL-cholesterol or tobacco dependence.   "
143297|NCT01408745|"     The primary objective is to establish if the SternumFix System improves sternal closure. The     study should test the hypothesis that in a high risk patient population with increased risk     for the development of sternal wound complications SternumFix will reduce the incidence of     sternal healing complications. The control group will be treated with wire cerclage, the     standard method of sternal closure.   "
143298|NCT01408732|"     The purpose of this study is to test a novel and tolerable office-based treatment method,     sclerotherapy with sodium tetradecyl sulfate, for recurrent epistaxis (nosebleeds) related to     Hereditary Hemorrhagic Telangiectasia (HHT) disease.   "
143299|NCT01408719|"     The primary aim of this study is to determine whether the cholesterol-lowering efficacy of     barley b- glucan varied as function of molecular weight (MW) and the total daily amount     consumed. Our second aim is to investigate the mechanism responsible for the action,     specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting     cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet     interactions are associated with cholesterol lowering by barley β-glucan. In addition, we aim     to investigate the alteration of the gut microbiota after β-glucan consumption and the     correlation between the altered gut microbiota and cardiovascular disease risk factors.   "
143300|NCT01408706|"     The purpose of this study is to compare reproducibility of the device position and location     of the prostate rectum interface between two immobilization devices for radiation therapy of     prostate carcinoma.   "
143301|NCT01408693|"     The aim of the study is to test the hypothesis that patients older than 60 years with a     femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior     minimal-invasive approach as compared to a standard lateral Hardinge approach show better     functional recovery postoperatively as measured by the Timed up and go-test (TUG).   "
143302|NCT01408680|"     The investigators believe that relieving the oxidative stress experienced by hemodialysis     patients may help improve cardiovascular health.      In this study, the investigators hypothesize that administration of coenzyme Q10, as a     targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by     hemodialysis patients. This will lead to improvements in biomarkers of:        -  oxidative stress status        -  inflammatory status        -  endothelial dysfunction   "
143303|NCT01408667|"     The purpose of the study is to determine the safety and efficacy of TRC150094 in male     patients with cardiometabolic risk. Cardiometabolic risk which is the overall risk of     cardiovascular disease (CVD) and diabetes resulting from the presence of hypertension, HDL     cholesterol, insulin resistance, dysglycemia and visceral obesity.   "
143304|NCT01408654|"     This randomized trial compares peer companionship to care-as-usual in primary care on the     outcome of risk for suicidal behavior in late life. The investigators hypothesize that older     adults assigned to receive peer companionship will report greater social connectedness and     less death and suicidal ideation compared to older adults assigned to care as usual.   "
143308|NCT01408602|"     This study will treat moderate to severe rheumatoid arthritis with MRC375 (either 75 mg 3     times a day, 150 mg 3 times a day or placebo 3 times a day)in patients 18 years of age or     older that can be currently on low doses of methotrexate or can stop treatment of current RA     medications to enter the study. Safety of MRC375 will also be evaluated. There are up to 8     clinic visits over 24 weeks.   "
143309|NCT01408589|"     This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40,     60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited     craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the     fact that it targets NET, neither of which has heretofore been examined in the context of     alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will     provide the PI with sufficient preliminary data to submit a subsequent R01 application to     study atomoxetine and the involvement of specific single nucleotide polymorphisms within the     NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations.     The long-term objective of this research is to develop more efficacious treatment     interventions for alcohol abuse and dependence.      Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine     for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who     receive a placebo.      Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine     for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication)     than subjects who receive a placebo.   "
143310|NCT01408576|"     The primary objective of the study is assess the safety and tolerability of long-term     epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)   "
143311|NCT01408563|"     This trial will use two cord blood units for transplantation using a reduced intensity     regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood     units (double cord blood) are being used, as the numbers of blood cells in one unit are too     few to allow successful growth of these cells.      Because the risk of infection, particularly virus infection, is high after double cord blood     transplant, this study seeks to reduce the rise of virus infection by using a reduced     intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior     cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and     fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The     number of patients with virus infections in this study will be compared to our prior     experience using the ATG.   "
143312|NCT01408550|"     Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national     diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the     exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five     consecutive days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for     therapy of bullous pemphigoid will be evaluated the score using pemphigus disease area index     (PDAI) and pemphigoid activity score involving skin lesion area and Number of new blisters.      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse     events by 57 days after the start of the study treatment.   "
143313|NCT01408537|"     Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia     including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the     total number of clinical cases is about 50,000. Of these cases, about 50% result in permanent     neuropsychiatric sequelae. The disease occurs mostly among children aged <10 years. There is     no specific antiviral treatment for JE. Vaccination is the single most important control     measure. This study aims to evaluate the immunogenicity and safety of inactivated Vero cell     derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da Biotechnology Co., Ltd,     China JEVAC in Thai children.      152 healthy Thai children aged between 1-3 years will be vaccinated with JEVAC in a dose of     0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year     (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at one     year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13 months     study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing P3     strain. Adverse events will be observed for 28 days after each vaccination. Serious adverse     events will be observed throughout the study period.   "
143314|NCT01408524|"     The purpose of this study is to determine the effectiveness of the antihypertensive drugs in     the control of emergence blood pressure after tumor resection craniotomy; compared between     labetalol (Avexa) and diltiazem (Herbessor).      Also the investigators seek to determine the effective dose of the antihypertensive drugs and     their side effects in Thai population.   "
143315|NCT01408511|"     A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat     0.1% ointment in adults with atopic dermatitis.   "
143316|NCT01408498|"     The study aims to establish a clear causal link between testosterone and threat perception     and behavioral responses to threat. Namely, the study focuses whether high levels of     testosterone will cause an individual to exhibit increased physiological responses to threat     (e.g., increased blood pressure, heart rate, and endocrine responses) and a decreased     behavioral response (e.g., ignoring the threat, avoiding the threat, and postponing dealing     with the threat). The threat in this study is a social threat involving public speaking, and     is an outgrowth of previous research on the avoidance of health threats.   "
143317|NCT01408485|"     To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is     effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its     use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse     events.   "
143318|NCT01408472|"     Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to     enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in     diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide     neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in     glaucoma. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into     one eye, and will be carefully followed to evaluate safety and efficacy.   "
143507|NCT01405989|"     The primary objective of this study is to determine the effect of ketoconazole on the blood     concentrations of darexaban and its metabolites (drug degradation products). The secondary     objective of the study is to evaluate the safety and tolerability of a single dose of     darexaban alone and when administered together with ketoconazole.   "
143319|NCT01408459|"     The purposes of this study are to explore the dynamics of adherence, using a simple whole     food intervention strategy, both prior to and during the intervention period and to identify     nutrient shifts in self-selected diets and to determine health risks (blood pressure,     hyperlipidemia, and body weight) that may have resulted from increased tomato product     consumption.   "
143320|NCT01408446|"     Prehypertension and mild hypertension are associated with an increased risk of     atherosclerosis and coronary artery disease, and often complicated with the metabolic     disorder of glucose and lipid. The comprehensive prevention of hypertension is still an     important and complex clinical issue. Peppermint is a popular flavoring agent, and peppermint     tea help relax tension and could lower blood pressure. The effect of oral peppermint on blood     pressure is not consistent, however, our previous animal study has shown that oral     administration of menthol, the main component of peppermint, could reduce 24-hour mean     arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. Furthermore,     menthol increases uncoupling protein(UCP)1 dependent thermogenesis and energy expenditure     through transient receptor potential melastatin(TRPM)8 activation, and helps prevent obesity     and metabolic disorders. In a prospective, double-blind, randomized, and parallel-group     study, we will evaluate the effects of DANSHU capsule(menthol) on blood pressure and     metabolic parameters in prehypertensive and mild hypertensive patients. This study will help     develop future comprehensive prevention and treatment strategies for hypertension.   "
143321|NCT01408433|"     This study seeks to compare the pregnancy and delivery rates of patients who undergo a single     embryo transfer, when the embryo has been tested and determined to be chromosomally normal,     with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer of     untested embryos.   "
143322|NCT01408420|"     In Denmark around 3500 procedures are conducted involving a heart-lung-machine per year. An     increase in the prevalence of postoperative kidney insufficiency have been observed following     these procedures, during the last years. Kidney related complications are associated with a     higher mortality and morbidity.      The reason and mechanisms behind this impaired kidney function is unknown. One possible cause     could be that the blood pressure used in the heart-lung-machine is too low, during surgery.     In the PPC trial we plan to include 100 patients. One half of the patients are operated with     a normal, lower, blood pressure on the heart-lung-machine. The other half receives a blood     pressure of > 60 mmHg during surgery.      The primary goal of the trial is to measure the kidney function (GFR) the day before surgery     compared to day 4 - 6 and 4 months (+/- 14 days) after surgery. During the surgery a catheter     is inserted through the femoral vein into the kidney vein. This makes it possible to measure     several biochemical markers and the oxygen consumption of the kidney, during the surgery.     Urine samples are also collected and analyzed.      The study hypothesis:      The glomerular filtration rate (GFR) is better preserved after cardiac surgery with extra     corporal circulation with an intended increased periprocedural arterial blood pressure     compared to current practice.   "
143323|NCT01408407|"     The purpose of this study is to determine whether Alkagin paste is effective at preventing     radiodermatitis in patients receiving external beam radiation therapy to the perineal area.   "
143324|NCT01408394|"     Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible     diseases. To date, all clinical studies have been done using the ecopipam immediate release     (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been     produced that may be able to improve its effectiveness and reduce its side effects. The main     purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when     given as single oral dose in healthy volunteers.   "
143325|NCT01408381|"     Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group     controlled with three levels of dose.      The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide     progenitor cells with regenerative capacity and besides secrete several angiogenic factors,     and their implantation into ischemic tissues with both elements should contribute to     angiogenesis and tissue regeneration with recovery of the circulation in the affected limb.   "
143326|NCT01408368|"     The extent of thyroid resection in Graves' disease remains controversial. The aim of this     study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total     thyroidectomy in patients with Graves' ophthalmopathy.   "
143327|NCT01408355|"     To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose     via both intravenous and oral routes.   "
143328|NCT01408342|"     The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and     rituximab as first line therapy in aplastic anemia.   "
143329|NCT01408329|"     Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like     device to expose users to controlled fluctuations in air pressure. It is designed to promote     quicker altitude acclimatization, thus promoting improvements in exercise capacity at     altitude and, possibly, at sea level. However, over the past few years, anecdotal stories     from users of the device suggest that the CVAC treatments might be causing changes beyond the     expected endurance exercise performance benefits. Therefore, the purpose of the study is to     obtain data on some of the previous anecdotal claims regarding the device (e.g. increases in     strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint     swelling) as well as to obtain broad questionnaire data in order to identify more specific     variables to investigate in future studies.   "
143330|NCT01408316|"     This is a two part study designed to evaluate the PK profile of PX-866 capsules versus     tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy     volunteers.   "
143331|NCT01408303|"     The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an     optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in     subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.   "
143332|NCT01408290|"     The purpose of this study is to determine the immunogenicity, tolerability and dose-effect     relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent     influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1,     A/H3N2 and B influenza antigens in adults and elderly people.   "
143343|NCT01408147|"     This study will examine the effects of an online behavioral intervention to promote weight     loss in low income postpartum women in the WIC program.   "
143333|NCT01408277|"     Subjects enrolled in this study will either use Santyl daily or follow standard care     procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the     subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will     look at the wound in the office each week (up to 12 weeks) to see if the wound is healing.     Depending on a number of factors at each office visit, the study doctors may also use a     procedure called sharp debridement to remove dead skin from the wound.      This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl     will result in more rapid healing, healthier wounds, and fewer required sharp debridements     over the study period than for diabetic foot wounds treated in other ways.   "
143334|NCT01408264|"     The aim of this study is to determine whether using a smaller wire results in a higher     success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence of     adverse events   "
143335|NCT01408251|"     The purpose of this study is to see if blood obtained from a vein (smaller blood vessel) can     be used instead of blood obtained from an artery (larger blood vessel).   "
143336|NCT01408238|"     The objective of this study is to determine the biologic activity of a Secale cereale     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house     reference preparation (IHRP).   "
143337|NCT01408225|"     The investigators are researching patients with diseases of their plasma cells in order to     improve their quality and length of life. The investigators have created a database of     patient information, blood samples, and bone marrow tissue in order to achieve the following     three goals:        -  Surveillance: The investigators want to track what treatments patients get or don't get,          how effective they are, how they feel, what complications they suffer, how long they          stay in remission, and how long they live.        -  Contact: Because myeloma and amyloidosis are rare, less than 700 patients are diagnosed          in the state of Ohio each year, patients often feel they don't have accurate          information. The investigators want to provide them access to our clinical team (both          phone and email consultations, even office visits for patients that can come to          Columbus) as well as information regarding informational events pertaining to your          disease and local support groups.        -  Research: Because nearly all myeloma and amyloid patients relapse and treatment is          eventually unsuccessful, our focus is to develop more effective treatments that not only          prolong life, but cure the disease. Periodically the investigators will inform them          about clinical trials studying new drugs or treatment paradigms.   "
143338|NCT01408212|"     This study aims for evaluating the effectiveness, safety and feasibility of additional     acupuncture therapy for lung cancer patients who are under chemotherapy in an inpatient     setting. The acupuncture therapy will be administered during a resting period between cycles     of chemotherapy.   "
143339|NCT01408199|"     Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous     involvement at some point during course of their disease. In spite of the esthetic     consequence during the acute phase, the main problem is still related to its disfiguring and     incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the     conventional therapy. Unfortunately, approximately 30% will be refractory to these measures.     For those patients, immunosuppressive therapy can be an alternative with controversial     results. Several series have shown a 90% of clinical efficacy in patients treated with     Thalidomide. Unfortunately, the main drawback has been the serious described side effects     such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide     analogue, more potent, efficient and with better safety profile has been discovered. The main     objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients     with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this     drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare     after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve     patients with refractory cutaneous lupus will be included. Lenalidomide will be started at     5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the     end of follow up.   "
143340|NCT01408186|"     Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in     Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half of     all cases of hospitalizations for peptic ulcer bleeding. Currently, ASA use has contributed     to about one-third of the bleeding ulcers admitted to the investigators hospital that serves     a local population of 1.5 million.      In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced     bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a     major dilemma. In another double-blind randomized trial, the investigators have shown that     discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a     significantly increased in mortality within 8 weeks.      In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the     dominant preventive strategy. Given the vast number of people taking ASA, however, it is only     cost-effective to identify and treat those who are at high risk of ulcer bleeding and who     have a strong indication for ASA use. Data from observational studies and randomized trials     have consistently shown that PPIs are effective in reducing the risk of ulcer bleeding     associated with ASA. Other potential preventive strategies include eradication of H. pylori     infection, substitution of ASA for other non-aspirin anti-platelet drugs, and co-therapy with     misoprostol or H2RAs.   "
143341|NCT01408173|"     The aim of the present Phase III study is to evaluate the safety, efficacy and     pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.   "
143342|NCT01408160|"     This phase I trial studies the side effects and the best dose of deglycosylated ricin A     chain-conjugated anti-cluster of differentiation (CD)19/anti-CD22 immunotoxins when given     together with cytarabine in treating patients with B-cell acute lymphoblastic leukemia that     has come back after a period of improvement (relapsed) or does not respond to treatment     (refractory). Immunotoxins, such as deglycosylated ricin A chain-conjugated     anti-CD19/anti-CD22 immunotoxins, can find certain cancer cells and kill them without harming     normal cells. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or     by stopping them from spreading. Giving deglycosylated ricin A chain-conjugated     anti-CD19/anti-CD22 immunotoxins with cytarabine may kill more cancer cells.   "
143345|NCT01408121|"     This is a genetic and platelet reactivity study of African-American versus Caucasian patients     undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. The     investigators aim is twofold: to describe differences in allele frequencies between     African-Americans and Caucasians, and to explore associations of platelet reactivity and     genetic polymorphisms in these two groups.   "
143346|NCT01408108|"     This study is prospective randomized trial enrolling at least 100 participants which compares     efficacy and safety of two alternative methods of laparoscopic hiatal repair for large (i.e.     with hiatal surface area (HSA) ranging from 10 to 20 sq.cm, which corresponds to diameter of     defect from 5 to 8 cm) types I, II, and III hiatal hernias: primary crural repair and repair     with partially absorbable lightweight mesh. According to the literature, rates of anatomical     failure and recurrence of GERD after primary repair of large hiatal hernias reach 42 %. Mesh     repair decreases rates of failures, however, polypropylene and composite PTFE meshes used     most widely, result in unacceptable rates of long-term dysphagia and oesophageal strictures.     Our own experience of more than 400 repairs using partially absorbable lightweight mesh     Ultrapro (Ethicon) and original sub-lay technique of its fixation precluding contact of the     mesh with the oesophagus, showed low recurrence rate and a few cases of long-term dysphagia.     Thus, final conclusions could be established by prospective randomized study. Our hypothesis     is: original technique of lightweight mesh repair is highly effective for prevention of     recurrences compared to primary repair and safe in terms of mesh-related dysphagia and     oesophageal strictures. The long-term results (24 months post surgery for every patient) will     be studied using symptom questionnaires, quality of life and satisfaction questionnaires,     barium studies, endoscopic examinations, 24-hour pH testing, and analysis of possible     reoperations.   "
143347|NCT01408095|"     The study is designed to see if once daily oral dosing of LY2608204 will help control     diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will also     help to determine the safety of the medication and the most useful doses of the medication.   "
143348|NCT01408082|"     The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared     to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with     Non-bacterial Blepharitis.   "
143349|NCT01408069|"     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two     different associations of drugs in the treatment of patients diagnosed with tensional-type     headache in accordance with International Headache Society guidelines.   "
143350|NCT01408056|"     The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe     and effective in promoting wound healing of infantile ulcerated hemangiomas compared with     standard conservative management with topical antibiotic.   "
143351|NCT01408043|"     This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell     mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such     as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's     bone marrow to the blood so they can be collected and stored.   "
143352|NCT01408030|"     The purpose of the NOSE Study is to carefully examine the efficacy and safety of 3 nasal     sprays (bevacizumab, estriol, and tranexamic acid), compared to placebo, for the treatment of     HHT related nosebleeds.   "
143353|NCT01408004|"     In this study will be examined whether alternating treatment between two classes of drugs     (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal     cancer.   "
143354|NCT01407991|"     The purpose of this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube     placement for efficacy and safety in the placement of NG/OG tube in infants less than 6     months of age. One method is based on the infant's length determined by measurement using a     length board and plotted on a graph derived from a formula to determine the depth for tube     insertion (graph method) and the other method is based on current standard of care, measuring     from the nose to the ear and then the ear to mid abdomen (NEM) and mark the tube to know how     far to insert the tube. Outcome comparison will be xray verification of placement.   "
143355|NCT01407978|"     This is a single-blind, reference drug controlled study to assess safety and tolerability of     FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn     phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To     assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology     testing.   "
143356|NCT01407965|"     Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.   "
143357|NCT01407952|"     This research study is being done to test the effectiveness of a new generation FDA approved     device for treating aneurysms compared to the current standard device for endovascular     aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of     minimally invasive surgery, which is performed on blood vessels. The technique involves the     introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the     skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found     near the groin. The catheter is then maneuvered through the body to the location of the     aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the     catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter.     This is repeated until enough coils fill the aneurysm, blocking the blood flow to the     aneurysm. The body responds by forming blood clots around the coil(s), which helps block the     flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study     will compare the study device to the standard bare platinum coil to see which is better at     preventing future rupturing or leaking. The study device is called the HydroCoil Embolization     System and this study is a post-market clinical trial.      About 600 subjects from multiple institutions will take part in this study.   "
143370|NCT01407783|"     NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington     University in St. Louis. This study explores the co-location of depression treatment within     nurse home visitation and the organizational changes needed to maintain access to     evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment     because it is well suited for use by non-mental health specialists and for in-home treatment.     It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.   "
143358|NCT01407939|"     This proposal describes 2 basic research studies that will be conducted sequentially. Study 1     will test the efficacy of both classic and newly developed generally recognized as a safe     (GRAS) bitter blockers on the perceived bitterness and acceptance of different classes of     bitter-tasting compounds by children and compare their responses to adults. Because     variations among and between children and adults in terms of sensitivity to different bitter     compounds are due in part to genetically determined receptor variation, the investigators     will consider genotype when assessing how well bitter blockers perform. In Study 2, the     investigators aim to evaluate different methods (forced-choice procedures, hedonic face     scales) used for testing children to determine their reliability and reproducibility.   "
143359|NCT01407926|"     Objective: The objective of this study is to evaluate the feasibility, acceptability and     effectiveness of a 6-month nurse-led, interprofessional mental health promotion intervention     aimed at older home care clients with depressive symptoms using personal support services.      Methods/Design: This one-group pre-test post-test study aims to recruit a total of 250     long-stay (> 60 days) home care clients, 70 years or older, with depressive symptoms who are     receiving personal support services through a home care program in Ontario, Canada. The     nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that     involves regular home visits, monthly case conferences, and evidence-based assessment and     management of depression using an interprofessional approach. The primary outcome is the     change in severity of depressive symptoms from baseline to 6 months using the Centre for     Epidemiological Studies in Depression Scale. Secondary outcomes include changes in the     prevalence of depressive symptoms and anxiety, health-related quality of life, cognitive     function, and the rate and appropriateness of depression treatment from baseline to 12     months. Changes in the costs of use of health services will be assessed from a societal     perspective.   "
143360|NCT01407913|"     The study hypothesis is that caudal epidural steroid injections provides short term relief to     patients with persistent low back pain and sciatica due degenerative disc disease or lumbar     spinal stenosis. Patients will be evaluated wiht clinical examination and radiological     examinations before injections. They will be followed up with questionnaires on pain and     disability up to 6 months postinjection.   "
143361|NCT01407900|"     The overall aim is to conduct a human physiologic study to assess the renal and neurohumoral     effects of CD-NP vs placebo in older subjects with stable chronic systolic heart failure and     moderate renal dysfunction.   "
143362|NCT01407887|"     Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for     falciparum malaria treatment in African children: randomised controlled trial.      Design: Mono-centre, two arms, open randomized controlled study in children with     uncomplicated falciparum malaria in Burkina Faso.      Phase: Phase II.      Objectives: The primary objective of this trial is to study the efficacy and safety of the     triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days     in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local     standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.      Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna     Hospital in north-western Burkina Faso.      Sample size: 180 patients (90 per study arm).   "
143363|NCT01407874|"     To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol     in subjects with moderate renal insufficiency.   "
143364|NCT01407861|"     This is a single centre, open label, prospective, randomized study on the prophylactic effect     of moderate aerobic endurance training versus relaxation training in patients with migraine.   "
143365|NCT01407848|"     In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and     term neonates with Transient Tachypnoea.   "
143366|NCT01407835|"     The objective of this study is to determine the biologic activity of a Dactylis glomerata     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house     reference preparation (IHRP).   "
143367|NCT01407822|"     Stage IIIA NSCLC represents a relatively heterogeneous group of pts with ipsilateral     mediastinal (N2) lymph node involvement. The relative roles of treatment modalities are not     clearly defined. Concurrent chemoradiation therapy remains an important treatment for stage     IIIA disease, but its treatment-related life threatening toxicity limits its use. The EGFR     tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary     adenocarcinoma carrying EGFR activating mutations in the metastatic setting. In the OPTIMAL     study, first-line erlotinib versus carboplatin/GEM in advanced NSCLC pts with EGFR activating     mutations, the primary analysis showed significantly prolonged progressive free survival     (PFS) was with erlotinib vs carboplatin/GEM (p<0.0001). The aim of this study is to     investigate the efficacy and safety of erlotinib versus GEM plus cisplatin (GC) as     neoadjuvant treatment in pts with stage IIIA-N2 NSCLC with EGFR activating mutations and to     explore a new treatment strategy for this subset.   "
143368|NCT01407809|"     Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and     is associated with headache and loss of vision. The medical and surgical management of IIH is     problematic and many patients are not treated effectively. Some cases of IIH are associated     with severe stenosis of the large veins of the brain and various researchers have recently     reported significant improvement in patients with IIH after the narrow veins of the brain     were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of     venous sinus stenting in patients with severe IIH refractory to medical management.   "
143369|NCT01407796|"     The overall purpose of this research is to gain understanding of the basic responses of the     lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and     involves red, warm, and often painful swelling of the affected tissue. Acute lung injury     involves a generalized inflammation to the lung that is activated by any of several     conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is     severe, not enough oxygen can get into the body; this can lead to the need for mechanical     support of breathing (mechanical ventilation), problems with brain, heart or other organ     function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to the     development of lung inflammation.   "
144018|NCT01399320|"     Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety     of problems, including infection/abscess and the development of a chronic sinus cavity.here     we try a minimmally invasive method for managing such condition   "
143371|NCT01407770|"     RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy     may cause skin reactions when patients are exposed to high-energy x rays. Studying the     genetic pattern of patients before and after radiation therapy may help doctors prevent     toxicity and plan the best treatment.      PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin     reactions in racial/ethnic groups of patients with breast cancer.   "
143372|NCT01407757|"     RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well     patients will respond to treatment. It may also help doctors learn more about how gemtuzumab     ozogamicin works in the body.      PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients     with acute myeloid leukemia treated on COG-AAML0531.   "
143373|NCT01407744|"     This research trial studies tumor samples from patients with ependymoma treated on the     Children Oncology Group ACNS0121 trial. Studying samples of tumor tissue from patients with     cancer in the laboratory may help doctors learn more about changes that occur in DNA and     identify biomarkers related to cancer. It may also help doctors find better ways to treat     cancer.   "
143374|NCT01407731|"     RATIONALE: Studying protein expression in samples of tumor tissue from patients with cancer     in the laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors find better ways to treat     neuroblastoma.      PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples     from patients with neuroblastoma.   "
143375|NCT01407718|"     This project will address the incidence of anterior knee pain in the approaches used for     tibial nailing. A parapatellar approach, with nail insertion in relative extension, will be     compared to the approaches in which nail insertion requires the knee to be placed in flexion.     The incidence of anterior knee pain will be compared in each group to assess whether the     compared approaches result in similar levels of anterior knee pain. Patients will be given     the 2000 IKDC Subjective Knee Evaluation Form to assess anterior knee pain. The 2000 IKDC     Subjective Knee Evaluation Form is a newer assessment tool created by the International Knee     Documentation Committee. It has been validated for use with broad patient populations dealing     with various knee disorders.19   "
143376|NCT01407705|"     The investigators propose a prospective study, designed to analyze the efficacy of     High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in     subjects with spinal cord injury. Study subjects will not be randomized, as treatment will     follow the doctor's standard of care. Patients will be selected and offered enrollment     based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease     or trauma. Enrollment will be based on the chronology of patient presentation.   "
143377|NCT01407692|"     The purpose of this study is to determine if the phase of the menstrual cycle (opposed versus     unopposed estrogen phase) affects eating behavior, including types of foods preferred,     wanting/desire for specific foods, and perception of hunger.   "
143378|NCT01407679|"     To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE     with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area     and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of     treatment or at the latest assessment for patients who withdrew prematurely. Response is     defined as a reduction of 50% in the total RCLASI compared to the baseline value (RCLASI     50).   "
143379|NCT01407666|"     This prospective, randomized study is intended to assess the efficacy and safety of bilateral     continuous paravertebral blocks compared to continuous epidural block for open liver     resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in     controlling the perioperative pain; and 2) safe, with less frequent complications following     open liver resection when compared to continuous epidural block.   "
143380|NCT01407653|"     Chronic low back pain and sciatica in adults represent a major medical and economic problem.     During the chronic back pain (persisting continuously over 3 months), therapeutic responses     to conventional pharmacologic type are often ineffective and the impact of pain is often     heavy in terms of disability, social and professional avulsion and loss of quality of life.     This failure has led in recent years to propose innovative strategies such as application of     relaxation therapy techniques. An example is a virtual reality which is a technology to     immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion     combined with virtual reality can be effective on chronic pain. The main purpose is to     measure the impact on the intensity of pain at 4 months after using of a new method for     virtual environment, mimicking the colors from low to high frequencies (World Patent Filed,     WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to     therapeutic drugs.   "
143381|NCT01407640|"     Insulin allergy (IA) is still observed even with recombinant human insulin and insulin     analogs.      Obviously, the usual attitude facing an allergy, i. e. exclusion of the allergen, poses     problems in face of IA because insulin is often vital for the patient. IA is thus a complex     situation in which a rigorous diagnostic procedure to identify the exact allergen is     necessary to propose a therapeutic answer; the purpose of the study is 1/ to validate a     diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate     immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA.   "
143382|NCT01407627|"     Fructose is an ingredient that is added to many of our foods. It is a cheaper, sweeter     additive that can be found in everything from soda pop to yogurt to granola bars. In the last     few years a significant number of studies have been published linking consumption of fructose     with obesity, hypertension and more recently, kidney and cardiovascular disease.      Animal studies show a strong link between excessive ingestion of fructose and the development     of kidney and cardiovascular disease mediated by the renin angiotensin system, a hormonal     system whose activation is detrimental to both the kidney and the heart. There has been very     little research done on the potentially pathophysiological relationship between a high     fructose diet and kidney and cardiovascular disease in humans.      The investigators hypothesize that ingestion of fructose will result in upregulation of the     renin angiotensin system in healthy humans.   "
143383|NCT01407614|"     In a prospective randomized controlled trial, the investigators aim to assess whether     external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its     sequelae in patients with an aneurysmal subarachnoid hemorrhage.   "
143384|NCT01407601|"     Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality.     Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein     (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on     vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of     vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed     towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily     vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins in     HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP),     noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).   "
143385|NCT01407588|"     The purpose of this study is to compare manual and magnetic navigation in ablation for atrial     fibrillation.   "
143386|NCT01407575|"     The purpose of this study is to compare the safety and efficacy of buprenorphine with placebo     for adults with treatment resistant depression (TRD).   "
143387|NCT01407562|"     This is an open label, dose escalation study to determine the safety and tolerability and     maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in     patients with advanced solid tumors.   "
143388|NCT01407549|"     Background: Chronic pain is a common condition in the general population, causing great     suffering in both physical and mental aspects. Previous research shows that mindfulness based     interventions help chronic pain patients to cope better with their pain, and improve their     quality of life. Although evidence support the efficacy of mindfulness based interventions     for chronic pain, it is still unclear whether this efficacy involves a direct influence on     sensory aspects of pain perception. Further more, the mechanisms of change responsible for     the improved life quality and the possible moderating factors that may influence treatment     efficacy, are still unknown.      Aim: The purpose of this study is to evaluate the efficacy of mindfulness based intervention     on pain perception and quality of life in individuals suffering from chronic pain. The     investigators will also evaluate potential mechanisms responsible for the change following     mindfulness practice. Finally the investigators will examine the role of personal     characteristics as potential moderating factors of mindfulness effect.      Hypothesis: The investigators hypothesize that 1) compared to a waitlist control group,     chronic pain patients participating in a full mindfulness based program will report greater     improvements in a) pain severity, b) quality of life and psychological symptoms, and c) will     demonstrate changes in physiological characteristics of pain. 2) Changes following the     mindfulness based program will be mediated by change in pain catastrophizing, self regulation     capacity and pain acceptance. 3) The investigators hypothesize that gender, baseline     mindfulness, and anxiety sensitivity will moderate the efficacy of the mindfulness based     program.      Method: A randomized controlled design will be used to evaluate the efficacy of mindfulness     based intervention on pain perception and quality of life in individuals suffering from     chronic recurrent low back pain and osteoarthritis. Participants will be randomized to a     mindfulness based treatment group, or to a waitlist control group, and will be assessed for     psychological variables and psychophysical pain assessment before treatment. Participants     allocated to treatment group will then attend six group meetings in which they will learn and     practice different mindfulness meditation techniques, and will be asked to practice these     techniques on a daily basis. Post treatment assessments will take place at the end of the     intervention for both treatment and control groups.   "
143389|NCT01407536|"     Functional magnetic resonance imaging (fMRI) has confirmed that thermal stimulation (TS) may     facilitate cortical excitability in healthy adults. However, it is unknown whether TS can     increase cortical excitability in stroke patients. Compared to the fMRI, the transcranial     magnetic stimulation (TMS) possesses more concise conditions in temporal resolution, and it     can present the cerebrum activation situation more instantaneously. This study aimed to use     TMS examining the effect on corticomotor excitability, reorganization and functional motor     recovery after TS on affected upper limbs of chronic stroke patients.   "
143390|NCT01407523|"     To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as     adjunctive treatment in subjects with Partial Onset Seizures after switching from the     equivalent Levetiracetam oral dose.   "
143391|NCT01407510|"     A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat     0.1% ointment in Japanese adults with atopic dermatitis.   "
143392|NCT01407497|"     While antiretroviral drugs have shown great promise in reducing HIV replication and thus in     reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial     and side effects are a potentially limiting factor. Development of an effective     safe-affordable vaccine is likely to be the best way to stop further virus spread. The study     aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg     delivered id in combination with MVA-CMDR boost im.   "
143393|NCT01407484|"     BACKGROUND: One couple out of 6 consults for infertility during their sexual life. In 60% of     cases a male factor is associated or is the main infertility factor. Inflammatory Syndrome     (IS), characterized by the presence of a leukocytospermia is found in 12% of the cases.     Leukocyte degranulation causes oxidative stress (OS) through the formation of free radicals     attacking the sperm cell functions.      HYPOTHESIS: To establish the responsibility of the IS, and OS, in chronicle inflammatory male     infertility, the investigators hypothesize that its treatment (as well as its possible cause)     must restore or improve the fertilizing capacity of patients sperm.      METHODS: This prospective randomized study will test the response to the treatment. The     investigators shall measure cellular degradation products due to the OS, thereby certifying     that it does have a deleterious effect on sperm cell. Seminal biochemistry will also assess     the impact of the syndrome on the genital tract glands and follow its evolution.      The patients will be included in the study as soon as the leukocytospermia will be >     0,5*106/ml or as soon as the elastase will be > 500 ng/mL.      The examinations will be performed using flow cytometry, CASA (Computer Assisted Semen     Analysis). The analysis of sperm morphology will be centralized.      Primary endpoint will be a reduction in the percentage of 8OH-dG below 35 %. We anticipate     that it should arrive to 20 % of the patients included in the arm treatment by corticosteroid     therapy. All in all will thus be needed 50 patients in the group placebo and 50 in the group     treated.      Secondary endpoint the improvement of the spermatic parameters and the reduction of the     fragmentation of the DNA of sperm cells to the treated subjects.      All these biological markers will be evaluated 6 month after the treatment:        -  Fragmentation of the spermatic DNA below 37 % during the follow-up in 6 months        -  Leukocytospermia and elastase        -  Seminal biochemistry        -  Other markers of the inflammatory syndrome and oxidative stress (protein carbonyl,          8OHd-Guanosine)        -  Possibly the radiological examinations (Ultrasound and MRI of the genital tract)      In addition it would allow us to propose a policy of prevention towards acquired     post-infectious male infertility.   "
143394|NCT01407471|"     The purpose of this study is to determine whether spironolactone could significantly reduce     cutaneous atrophy due to corticosteroids.   "
143395|NCT01407458|"     To examine the impact of a structured physical activity program focused on bone strength in     elementary school children in the framework of their physical education classes on:        1. Bone strength of children participating in the activity.        2. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal          jumping strength, static balance, dynamic balance and coordination.   "
143396|NCT01407445|"     Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.   "
143397|NCT01407432|"     Unexplained male infertility is increasing, and, nowadays, the investigators only can propose     palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a key for the     maintenance of genome integrity. A dysfunction in this pathway can be responsible of     spermatogenesis defects, and further, of infertility. Few assays have shown that folate     treatment can improve sperm parameters and fertility, till 30% in some of theses studies. The     purpose of the investigators study is to demonstrate the impact of folates treatment on     improvement of sperm parameters and on the rate of success of in VITRO fertilization     procedures.   "
143399|NCT01407406|"     Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese     populations to support future clinical development of BIIB023 in China and Japan.      Study Design: This is a single-dose study to assess the PK, safety, and tolerability of     BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy     volunteers. The Caucasian group is included to allow comparison of PK data from different     groups using data from the same study under the same controlled conditions.      Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up     to 100 days.   "
143400|NCT01407393|"     Glucosanol™, the medical device to be investigated contains a proprietary plant extract that     is a natural inhibitor of alpha-amylase and can reduce starch digestion.      The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body     weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the     efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.   "
143401|NCT01407380|"     This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and     clinical effects of orally administered PWT33597 mesylate in subjects with advanced     malignancies.   "
143402|NCT01407367|"     Chronic kidney disease (CKD) is common, but it is often over-looked in patients with this     disease when they are getting medical treatment. Patients with CKD have special needs for     their medical treatment. When these special needs are not considered their medical care may     lead to unintended harm (called safety events) which can cause hospitalization, more kidney     problems, and even death.      This research study has two purposes. The first purpose is to determine how participants feel     about wearing a medical alert bracelet or necklace that alerts health care workers that the     user of the bracelet or necklace has decreased kidney function. Medical alert bracelets are     often recommended for people who have other medical problems, such as diabetes. This medical     alert bracelet or necklace has an address to an informational website about the safe care of     patients with kidney problems. The investigators think that alerting health care workers that     a person has decreased kidney function may decrease their chances of having a medical injury     and improve the safety of their care.      The second purpose of this research study is to track how often people with kidney problems     may be exposed to medicines, tests, or procedures that might increase their chance of having     an accidental medical injury or safety event. Though some medical injuries can not be     prevented, the investigators want to find out what medical events in patients with kidney     problems might be preventable. The investigators also want to find out if other things might     increase a patient's chances of getting a medical injury, such as physical weakness or     medical instructions that might be confusing.   "
143403|NCT01407354|"     Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and     are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord     injury, individuals are able to walk less both in their home and in their community.     De-conditioning, or a lack of endurance and fitness also occurs. Several methods are     available to try to improve walking ability and the fitness of persons with motor incomplete     spinal cord injury. This study examines two of these methods. The first is the use of     robotically assisted body-weight supported walking using a device called the Lokomat. The     second is aquatic or pool-based exercise. The investigators are researching the impact of     these two techniques on walking ability and fitness in people who experienced motor     incomplete spinal cord injury for at least 12 months.   "
143404|NCT01407341|"     This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients     undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth     in patients undergoing surgery for spine cancer   "
143405|NCT01407328|"     During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the     shoulder and trachea, compressing the upper airway. Although the extravasation is generally     reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or     life-threatening complications. Furthermore, the soft tissue edema around the shoulder may     extend to the thoracic cage, compress the chest and induce the respiratory distress     immediately after surgery. The investigators attempt to determine the effect of shoulder     arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial     blood gases were measured and compared before and after the shoulder arthroscopic surgery.   "
143406|NCT01407315|"     Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped     with the GlucoMen®Day system, over up to 100 hours observation after implantation of the     microdialysis probe. Different meal/hypo procedures will be performed at the study centre.   "
143407|NCT01407302|"     Recently, laryngeal mask airway (LMA) placements are frequently performed for general     anesthesia. The investigators occasionally encounter a clinical situation to perform internal     jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway in     subjects undergoing major surgery. However, anatomic relations of IJV and common carotid     artery (CCA) in patient with LMA placement have been reported to be different from those in     patients with endotracheal tube. The degree of overlapping of the right IJV and CCA after LMA     placement was greater than before LMA placement. Furthermore, there are many cases of     complete overlapping right IJV and CCA after LMA placement. Therefore, the risk of puncturing     CCA increases when the investigators try to cannulate IJV after LMA placement. Furthermore,     the central landmark commonly used for IJV cannulation was proved to show low success rate     after LMA placement in previous report.      The investigators carefully examined the anatomic relations of IJV and CCA after LMA     insertion with ultrasonography, and found that the degree of overlapping is different     according to the degree of head rotation. The investigators postulated that if the degree of     overlapping is different according to the degree of head rotation after LMA insertion, the     investigators can find the angle of head rotation for least overlapping and reduce the risk     of CCA puncture. Therefore, the investigators tried (1) to find the optimal head rotation     angle appropriate for puncturing IJV after LMA placement, and (2) to find suitable landmark     adequate for IJV cannulation after LMA placement.   "
143408|NCT01407289|"     The purpose of the study is to compare the efficacy of enhanced published best practice     paper-based insulin titration protocol for glycaemic control in hospitalised patients with     type 2 diabetes for the length of hospital stay.   "
143410|NCT01407263|"     This study aims to determine how different ways of performing prostate cancer surgery affect     patient outcomes, such as recurrence of cancer or regaining control of bladder function     (continence) after surgery. Surgery to remove the prostate is known as a radical     prostatectomy. Surgeons know many things about the best way to do a radical prostatectomy.     However, there is uncertainty about some methods of surgery.      All of the surgeons who are taking part in this study have used these techniques at different     times. However, they are unsure as to what is the best approach. This trial will evaluate     whether the following two aspects of surgical technique influence outcome:      Lymph node template. Prostate cancer can sometimes spread to the lymph nodes near the     prostate. Surgeons often remove these lymph nodes to make sure that no cancer is left in the     body. However, there is uncertainty about which lymph nodes to remove (the template). In     particular, not all surgeons think that it is important to remove a large number of lymph     nodes. Some believe that prostate cancer found in the lymph nodes is not aggressive. As a     result, these surgeons feel that removing additional lymph nodes does not improve the chance     that a patient will be cured. In the study patients will either have the standard lymph node     dissection or a modified approach.      Port site incision. Some surgeries are conducted with the help of what is called a surgical     robot, or using a laparoscopic approach (sometimes known as keyhole surgery). The     surgeons have to make small cuts (incisions) in order to insert their surgical instruments.     Some surgeons believe that the way in which this cut is made can affect the chance that a     patient will develop a hernia in the months after surgery. This is when tissues in the     abdomen protrude through the incision, creating a small bulge that has to be surgically     corrected. In the study, patients will either have the incision made vertically or     horizontally.      Antibiotics. About a week after surgery, you will return to the hospital to have your     catheter removed. To guard against the chance of infection, you will be given antibiotics.     These do help prevent infection, but are also harmful. Doctors are unsure whether to give a     short course of antibiotics or whether patients really need several days of treatment. In the     study, patients will receive antibiotics for either one or three days.   "
143411|NCT01407250|"     Comparison of the quality of the outpatient clinic electrocardiogram performed on patients     sent to a cardiology consultation with a standard cable and the PhysioGlove-ES     electrocardiograms performed in the cardiology clinic.   "
143412|NCT01407237|"     The purpose of this study is to see if individuals with HIV-infection, particularly those     with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis.     Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the     body, and they may also have effects on sugar metabolism and cardiovascular health. There is     some evidence that individuals with HIV-associated abdominal fat accumulation may have     increased aldosterone, which may contribute to abnormalities in sugar metabolism and     increased cardiovascular disease seen in HIV. The purpose of this study is the measure renin,     angiotensin, and aldosterone activity, as well as other hormonal axes, in people with and     without HIV infection, and with and without increased belly fat. The investigators     hypothesize that aldosterone will be increased in HIV-infected individuals compared to those     without HIV-infection, and that aldosterone will be further increased in HIV-infected     individuals with increased abdominal fat compared to those without abdominal fat     accumulation.   "
143413|NCT01407224|"     The aim of this operational research is to compare the cost-effectiveness of two methods for     capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin     to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and     increase early exclusive breastfeeding in research areas of rural Bangladesh.   "
143414|NCT01407211|"     The aim of this study is the comparison between the effects of supplementation with vitamin A     (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in     multiple sclerotic patient.   "
143415|NCT01407198|"     The study drug, Nilotinib, is believed to slow down tumor growth by regulating a gene     involved in cellular growth of chordoma cells. During this research study, subjects will also     receive radiation therapy which is considered a standard treatment for advanced chordomas. It     is hoped by adding nilotinib, the benefits of radiation therapy can be enhanced without     adding significant toxicities.      The purpose of this research study is to determine the safety of nilotinib when used in     combination with radiation therapy, and the highest dose of nilotinib that can be given     safely with radiation therapy.   "
143416|NCT01407185|"     The purpose of this study is to determine the efficacy of a multi-disciplinary home program     consisting of specific education and home-based individualized combined aerobic and     resistance training exercise program for persons with heart failure (NYHA class II-III). The     investigators will assess effects on endurance, gait speed, lower extremity strength,     hospital re-admission rate and the quality of life in community-dwelling older adults from 60     - 85 years of age over a 12 month period.      Anticipated Results: The researchers expect confirm their hypothesis that there will be a     statistically significant difference between the experimental group receiving the combined     aerobic and resistance training program and the control group receiving usual care based on     strength, endurance, quality of life, falls, and hospital re-admission data.   "
143417|NCT01407172|"     This will be an observational study comparing the plasma levels of free hydrogen sulfide in     patients with and without peripheral arterial disease using a novel recently published method     of measuring hydrogen sulfide. The investigators will also see if there is any difference in     these levels between symptomatic and asymptomatic patients. Will examine the relationship of     these levels to known clinical risk factors as well as plasma nitrite and nitric oxide     levels. In doing the above the investigators hope to explore the utility of free hydrogen     sulfide as a biomarker for peripheral arterial disease.      Atherosclerotic peripheral arterial disease (PAD) of the lower extremities represents a     significant and growing cause of morbidity and mortality. The PARTNERS study of screening     ABIs in a primary care population of nearly 7000 individuals demonstrated a remarkable 29%     incidence of ABI <0.9, which is the commonly accepted level of abnormal ABI diagnostic of     PAD. Also of note in these patients with a new diagnosis of PAD the incidence of asymptomatic     PAD was a striking 48%. The availability of a biomarker will greatly enhance the care of     these patient and hopefully reduce morbidity and mortality.      The investigators believe that hydrogen sulfide (H2S), an endogenously produced     gasotransmitter, holds promise as a clinically useful biomarker for PAD and may also provide     a possible explanation for the paradox of asymptomatic PAD in patients with ABIs less than     0.9. To date, research regarding H2S has demonstrated that it participates in a myriad of     physiological functions including vasodilatation, anti-apoptotic effects, modulation of     mitochondrial respiration, and changes in vascular remodeling.   "
143418|NCT01407159|"     Cohort study according to national regulatory guidelines: Non-interventional, observational     cohort study. Pair-matched comparison with patients chosen from historical series.      To evaluate the clinical and technical success as well as the safety and feasibility of the     E-XL aortic stent used in complicated type B aortic dissection in addition to a classic     stentgraft in a single procedure.   "
143419|NCT01407146|"     The primary aim of this study is to increase our understanding of care-seeking behavior     surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet     based survey to ask individuals how they obtained medical care in the midst of a heart     attack. At present, care-seeking delay among individuals stricken with a heart attack     prevents them from obtaining the full therapeutic benefit of hospital based medical care in a     timely manner to reduce the long term health consequences of a heart attack. By using a     self-tailoring survey instrument the study attempts to take into consideration the complex     social processes by which the individual and their family make decisions to seek medical care     for symptoms of a heart attack. The study is designed to obtain a national sample of ACS     care-seeking behavior in the United States.   "
143420|NCT01407133|"     The objective of the investigators study is to assess conventional repetitive transcranial     magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized,     double-blind, sham-controlled procedure, with four increasing levels of magnetic     pseudo-dose has been designed, in order to characterize the effectiveness of rTMS while     controlling its safety and tolerability. By combining various rTMS protocols with a     twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the     effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected     benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of     therapeutic management.   "
143421|NCT01407120|"     The project is a 15-year follow-up of 240 young adults whose families participated in an     experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for     divorced families. The NBP was provided in late childhood; the follow-up occurred in young     adulthood. Families were randomly assigned to one of three conditions: mother program (MP),     dual-component mother and child program (MPCP), or literature-control (LC) condition.     Programs were designed to change several putative mediators of children's post-divorce mental     health problems using empirically-supported change strategies. The investigators expected     that the NBP would have either main or risk by program interactive effects on mental health     and substance use problems and disorders, developmental tasks, parent-young adult     relationships, physical health problems, and competencies, such that YAs who participated in     NBP will have better functioning than YAs in the control condition. The investigators     expected that the NBP will have either main or risk by program interactive effects on     mothers' mental health; those in the NBP are expected to have fewer mental health problems     than those in the control condition.   "
143422|NCT01407107|"     The purpose of this study is to determine whether topical nitroglycerin in addition to     5-flourouracil and radiation therapy are effective in the treatment of operable rectal     cancer.   "
143423|NCT01407094|"     This study will examine multiple carefully selected clinical and biological markers, using     both existing state-of-the-art technologies as well as pioneering, innovative approaches. The     study is designed to identify moderators and mediators of treatment response for depression     in order to specify a biosignature of treatment response for depression. Evaluation of the     usefulness of these markers in a carefully conducted clinical trial comparing an     antidepressant to placebo will assist in developing a Depression Treatment Response Index     (DTRI) to help clinicians match treatments to patients with MDD, resulting in timely     selection of treatments best suited for individual patients and thus approaching personalized     treatment. The resulting index provides a truly novel means of synthesizing the contribution     of key clinical and biological parameters in an easy to use tool for clinical care.   "
143424|NCT01407081|"     The purpose of this study is to provide evidence for the feasibility and initial     effectiveness of a manualized, telephone-based (telehealth) approach to the delivery of     cognitive interventions (SMARTease) targeted to improve cognitive performance in daily     activities after stroke.   "
143425|NCT01407068|"     The objectives of this study are to assess the safety and efficacy of concurrent     administration of two injections of AA4500 into the same hand of subjects with multiple     Dupuytren's contractures caused by palpable cords.   "
143426|NCT01407055|"     The purpose of this study is to evaluate the potential benefit of targeting patients'     expectations before coronary artery bypass graft surgery through a brief psychoeducational     intervention.   "
143427|NCT01407042|"     Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from     unicompartmental knee osteoarthritis. Two different types of UKA design are available - both     with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an     additional amount of cartilage and bone close to the implantat. It is unclear whether this is     of clinical relevance.      We speculate that the amount of cartilage/bone removal is related to the clinical outcome of     the UKA-surgery.      In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured     during the surgery. The clinical success of the procedure will be determined with certain     knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months     postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling     around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.      The three variables (removed amount of cartilage/bone; clinical success with regard to the     questionnaires; bone remodelling) are then analyzed with statistical methods to find out     potential assoziations among them.   "
143428|NCT01407029|"     This is a prospective, non-randomized, consecutive series, multicenter clinical study that     will include patients who will have total hip replacement with the R3 Acetabular System.   "
143429|NCT01407016|"     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of     metronidazole following single and multiple intravenous infusion in healthy Japanese adult     subjects.   "
143430|NCT01407003|"     This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy     subjects and in patients with T2DM.   "
143431|NCT01406990|"     The purpose of this study is to measure the percentage of women with known Coronary Artery     Disease (CAD) who are hyporesponsive to low dose (81 mg) aspirin.   "
143432|NCT01406977|"     The purpose of the study is to determine tolerability, PK/PD and preliminary efficacy of     BPS804 in adult patients with HPP treated with multiple escalating doses of BPS804.      This study will allow a comparison of several doses of the study drug within the first two     weeks after administration and after a longer assessment period for the highest dose level to     enable selection of dose ranges to be tested in subsequent studies in the HPP indication.   "
143437|NCT01406912|"     A multicentre, randomized, two parallel group study comparing virtual reality using Wii     gaming technology versus Recreational activities in patients receiving conventional     rehabilitation after an ischemic stroke.      Primary Hypothesis: Virtual reality using the Wii gaming system is more efficacious in     improving motor function than recreational therapy among patients receiving conventional     rehabilitation following a recent ischemic stroke.   "
143438|NCT01406899|"     In this behavioral trial 80 substance abusing individuals will be randomly assigned to either     treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR     treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period     of 8 weeks. Primary outcomes will be retention in treatment and reduction in substance use     (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to     demonstrate coping skills through a computerized role-play evaluation will be a secondary     outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.   "
143439|NCT01406886|"     This study will examine the independent and combined effects of energy density and eating     rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy     intake are expected to additively increase energy intake.   "
143440|NCT01406873|"     The purpose of this study is to investigate the effects of mexiletine treatment for 6 months     on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning,     cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).   "
143441|NCT01406860|"     The purpose of this study is to determine if droperidol is equally as effective as     metoclopramide for treatment of primary headaches in the Emergency Department.   "
143442|NCT01406847|"     Body-based interventions have consistently shown clinical effectiveness in patients with back     pain. The primary objective for this study is to compare the effect of body-based     interventions commonly used in the management of low back pain on behavioral and cortical     measures of pain sensitivity and central sensitization of pain. Participants will be randomly     assigned to receive one of the interventions or be in a control group. The central hypothesis     for this proposal is that spinal manipulation, a specific form of body-based intervention,     inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other     interventions. The completion of the proposed study will elucidate underpinning mechanisms of     body-based interventions. Identification of these mechanisms will improve the clinical     application and utilization of these interventions in the management of musculoskeletal pain     conditions, especially back pain.   "
143443|NCT01406834|"     The goal of this project is to test the feasibility, acceptability, and efficacy of a     treatment module addressing the mental health and functional impact of killing in the war     zone.      The investigators will enroll between 12-20 Veterans who have killed in war and have been     diagnosed with post-traumatic stress disorder (PTSD) for a pilot study assessing the efficacy     of the six-session treatment. Veterans will be randomized either to the treatment or to the     waitlist control group.   "
143444|NCT01406821|"     Platelet rich plasma has been used in previous studies to stimulate faster healing of torn     ligaments and tendons in order to help reduce pain and restore normal function. This study     aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries     with platelet rich plasma will reduce the time needed for participants to heal these injuries     and restore function.      We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.   "
143445|NCT01406808|"     The purpose of this study is to see if providing information to a person on their inherited     (genetic) risk of cardiovascular disease (CVD) helps to motivate that person to change their     diet, lifestyle or medication regimen to alter their risk.   "
143446|NCT01406795|"     To study the safety and efficacy of drug coated stents for the treatment of venous occlusions     and stenoses in the lower extremity. The use of the device for the treatment of peripheral     arterial disease is approved by the FDA, however, the use of the device in venous occlusions     and stenoses, although performed by some practitioners, has not yet been studied in detail.   "
143447|NCT01406782|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.     It may also help doctors predict how well patients will respond to treatment.      PURPOSE: This research study is studying DNA isolated from blood samples to see how well it     influences response to rituximab in patients with follicular lymphoma treated on clinical     trial ECOG-E4402.   "
143448|NCT01406769|"     This phase II trial studies bioimpedance spectroscopy in detecting lower-extremity lymphedema     in patients with stage I, stage II, stage III, or stage IV vulvar cancer undergoing surgery     and lymphadenectomy. Diagnostic procedures, such as bioimpedance spectroscopy, may help     doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer     undergoing surgery.   "
143449|NCT01406743|"     The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or     radiography, determining the lumbar pain cause and gravity, to propose a conservative     treatment in first intention or a adapted spine surgery in first or second intention     (Fritzell and al ., on 2001).      The analysis and the correction of postural disorders pass inevitably by a good knowledge of     the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS     ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.      However, the EOS technology ™ is recent and few data were acquired with this technology for     healthy population.      So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the     standing skeleton in position (to an asymptomatic adult population), by displaying the     gravity constraints on the joints, and the compensation phenomena in normal situation. This     functional information for a given age bracket would allow to propose to the patients with     lumbar pain, adapted interventions to the gravity constraints considering the skeleton     evolution for age bracket.   "
143450|NCT01406730|"     The purpose of the study is to determine the effect of 16 weeks of running exercise on     various parameters related to heart, vascular systems, blood, and muscle in untrained males     30-50 years old.      Further, the investigators assess which of the above mentioned parameters may explain the     increase of running performance most accurate.   "
143451|NCT01406717|"     SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in     reducing blood glucose levels. The purpose of study is to establish safety and efficacy of     SPIL1033   "
143453|NCT01406691|"     Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and     manifests as a difficulty in waking up in the morning, going to sleep early enough at night,     and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this     study is to determine if brief flashes of light, that are scheduled to occur during sleep,     are effective in treating DSPD.   "
143454|NCT01406678|"     Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces     myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with     cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study     assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest.     The study also addresses safety and clinical outcome.   "
143455|NCT01406665|"     Early detection of (pre)diabetes, including impaired glucose tolerance is currently deficient     because the best accepted standard, an oral glucose tolerance test (oGTT), is not feasible in     a setting of screening or broad case-finding and other current methods lack in sensitivity. A     previously reported study, and analysis of retrospective skin autofluorescence (AF) data,     suggests that noninvasive skin AF may offer an alternative for detection of (pre)diabetes.     The objective is to test the validity of a decision tree based on skin autofluorescence, and     some simple clinical characteristics, as a detection tool for diabetes and impaired glucose     tolerance. Sensitivity and specificity, positive and negative predictive value of this skin     AF based decision model will be compared to those of fasting plasma glucose (FPG), glycated     haemoglobin (HbA1c), and to two short questionnaires (Finnish Findrisk, and Cambridge score).      Study design: Skin AF, HbA1c and an oGTT (including an FPG) will be simultaneously performed     in at least 120 persons with the characteristics described in the following paragraph. A     Findrisk and Cambridge questionnaire will also be collected.   "
143456|NCT01406652|"     Th study investigates prospectively the cost-savings related to a one-stage bursectomy     (debridement, drainage and closure at the same time) versus two-stage bursectomy     (debridement, left open and closure at a second time) of severe bursitis among hospitalized     patients for surgical treatment of septic bursitis.      We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated     with a significant shortening of hospital stay, consumption of resources and increased     patient satisfaction.   "
143457|NCT01406639|"     This study is for patients with recurrent epistaxis (nosebleeds) as a result of Hereditary     Hemorrhagic Telangiectasia (HHT). The aim is to determine if ranibizumab, topically applied     will diminish epistaxis in patients with HHT as measured by the HHT Epistaxis Severity Score     (ESS), hematocrit, and hemoglobin and serum ferritin levels.   "
143458|NCT01406626|"     This study will implement a health navigation intervention to improve linkage to and     retention in HIV care for inmates released from L.A. county jail into the community.   "
143459|NCT01406613|"     This is a 2year observational study that will recruit patients who have previously completed     a randomised, open label, parallel, single centre study (TRIO Study) of three     bisphosphonates: alendronate, ibandronate and risedronate. These drugs are the most commonly     used group of treatments for postmenopausal osteoporosis in the UK. However, the length of     time for which these treatments continue to work after they are stopped has not been fully     elucidated. Without this information it is unclear as to how long doctors should treat and     whether it would be good practice to give drug 'holidays'.      The investigators plan to compare the effects on bone quantity and quality of stopping these     licensed bisphosphonates in patients who have taken the medication for a duration of two     years. The investigators aim to recruit up to 100 postmenopausal and up to 100 premenopausal     (reference range) subjects. Measurements collected at the final visit of the previous study     will be used for 'baseline' values for this study.      The postmenopausal group will have an initial study visit to secure informed consent, and     then further study visits at 24, 48, 72 and 96 weeks after stopping medication. Visit     procedures will include:      Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the     spine, hip, whole body, forearm Dual-emission X-ray absorptiometry (DXA), and heel dual X-ray     and Laser (DXL) Quantitative Ultrasound of Bone (QUS) Vertebral Fracture Assessment (VFA).      The premenopausal group will have one study visit, 96 weeks after completing the previous     study. Visit procedures will include:      Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the spine     and hip (DXA)      A subgroup of 50 premenopausal women will also have the following measurements:      Bone Mineral Density of the whole body, forearm (DXA), and heel (DXL) Quantitative Ultrasound     of Bone (QUS).   "
143460|NCT01406600|"     Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from     genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte     maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been     investigated about its safety and efficacy comparing with urinary hCG, but still the optimal     dose of rhCG is questionable. From former studies, there only have been proven that high dose     of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the other     hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor responders who     cannot easily provoke OHSS. Hence, this study will assess the comparative efficacy and safety     of 250mcg and 500mcg of rhCG in ART treatment cycle.   "
143461|NCT01406587|"     PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center,     randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of     symptoms associated with uncomplicated urinary tract infection. After the screening, patients     are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and     randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data     about uncomplicated urinary tract infection symptoms are collected from the subjects on     electronic handheld devices throughout the 48-hour study period. The primary endpoint is     burning during urination.   "
143462|NCT01406574|"     The purpose of this study is:      Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate     the efficacy   "
143463|NCT01406561|"     The purpose of this study is to assess the effect of OMS103HP solution for Injection     (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS)     Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms     in subjects undergoing meniscectomy.   "
143464|NCT01406548|"     This study is designed to provide information on the safety, tolerability, pharmacokinetics     (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing     regimens. This information will permit a comparison of the possible risks and benefits of     different dosing regimens of the study drug to enable optimal doses and dose intervals to be     tested in subsequent studies.   "
143506|NCT01406002|"     The primary objective of this study is to determine the effect of rifampicin on the way the     body handles darexaban and its metabolites (drug degradation products). The secondary     objective of the study is to evaluate the safety and tolerability of a single dose of     darexaban alone and when administered together with rifampicin.   "
143465|NCT01406535|"     The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5     inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with     therapy refractory myocardial ischemia due to coronary artery disease judged to be unsuitable     for surgical or percutaneous revascularisation. For proof of efficacy the following tests     will be performed at baseline and one day and 4 weeks after discontinuation of therapy:     Exercise tolerance will be evaluated by bicycle exercise testing. Blood tests will be     performed to evaluate markers of angiogenesis (endothelial progenitor cells, vascular     endothelial growth factor, basic fibroblast growth factor). The improvement of myocardial     perfusion will be tested functionally as increase of coronary flow reserve by positron     emission tomography. Moreover, changes in ventricular function, symptoms and quality of life     will be assessed.   "
143466|NCT01406522|"     No medications are currently available for treatment of psychostimulant addiction, a     compulsive preoccupation with use of cocaine and related compounds. Tacrine, a medication     that is currently prescribed for Alzheimer's disease, can decrease the amount of cocaine     injections that laboratory animals choose to inject by vein. This project will determine if     tacrine can also decrease cocaine-motivated behavior for human subjects in a laboratory     setting.   "
143467|NCT01406509|"     Haemophilus influenzae is an important pathogen which can cause primary infection and     respiratory viral infection in infants and leaded to secondary infections. The infection of     haemophilus is a major cause of morbidity and mortality in infants and children. At present,     the developed conjugant Hib vaccine is proved to be safe and effective, 90-99% of children     will produce antibody of protection after 3 doses. Because Hib vaccine can prevent     meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib     bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune     programming.      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent     years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus     polysaccharide vaccine with a relatively poor immune response in the infants under the age of     two, and the remaining 60% with a low antibody level and a short duration.      According to the present immunization schedule, to reach the median level of antibody levels     there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,     to provide high levels of long-term protection and to reduce the number of injections.      The objective of this study is to evaluate the safety of the group A, C polysaccharide     meningococcal and type b haemophilus Influenzal Conjugate vaccine.   "
143468|NCT01406496|"     Post-meal glucose excursions may contribute to the development of diabetes-related     complications. These glucose excursions are affected by the food content of the meal and the     timing of insulin injection (or insulin pump-bolus) before meal. The best timing for insulin     bolus (by pump) is controversial.      The aim of the study is to examine three different timings of insulin bolus in three types of     breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+ fat.     The 3h post-meal glucose excursions will be recorded by continuous glucose monitoring system.     The results obtained in the diabetic patients will be compared to those obtained in a group     of healthy individuals that will consume similar meals.   "
143469|NCT01406483|"     The primary objective of this exploratory cohort study is to describe levels of platelet     reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).   "
143470|NCT01406470|"     The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune     Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.   "
143471|NCT01406457|"     The goal in this research is to develop better ways to detect and treat the damage caused by     bleeding in the brain.   "
143472|NCT01406444|"     Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in     bone density). A significant decrease in bone density is called osteopenia or osteoporosis.     Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the     bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this     condition often have thin or weak bones that are more likely to break. They also have very     low levels of a chemical called IGF-1 in their body. This chemical is very important for     increasing bone growth in puberty and for maintaining healthy adult bones. The investigators     would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can     lead to an increase in bone formation, bone density, and bone strength in women with anorexia     nervosa.   "
143473|NCT01406431|"     The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan     co-administration and Livalo fixed combination drug in healthy male subjects.   "
143474|NCT01406418|"     The purpose of this study is to assess in healthy subjects the safety, tolerability,     pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal     antibody against influenza A viruses.   "
143475|NCT01406405|"     Purpose The primary purpose of this study is to prospectively compare clinical and     radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions     and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.   "
143476|NCT01406392|"     The purpose of this study is to compare effectiveness and safety of a sublingual misoprostol     12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term     fetus.   "
143477|NCT01406379|"     Although endoscopic colonic polypectomy has been an established procedure for two decades,     the risk of bleeding is still higher after resecting of pedunculated polyps, because of the     presence of a large artery in the stalk. Several preventive methods such as detachable snare     and adrenaline injection have been proposed in the management of postpolypectomy bleeding in     large colonic polyps. For prophylactic clip, there was no prospective randomized study     assessing the efficacy in the prevention of postpolypectomy bleeding for the large     pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy     of application of prophylactic clip and detachable snare in the prevention of postpolypectomy     bleeding in large polyps. Application of prophylactic clip will be as effective and safe     method as detachable snare in the prevention of postpolypectomy bleeding for the large     pedunculated colonic polyps.   "
144232|NCT01396525|"     To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable     Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native     common iliac artery and/or native external iliac artery.   "
143478|NCT01406366|"     Pediatricians serve an important role in promoting health in families. Bright Futures offers     a child and family-centered approach to health promotion in incorporating partnership and     communication skills of providers. Two areas of importance are in promotion of oral health     and prevention of iron deficiency. We plan to study implementing educational curriculum to     pediatric residents through a randomized controlled trial. Randomization will be done through     assignment at the level of pediatric training program. Residents randomized to Group 1 will     receive education about Bright Futures partnership and communication skills with oral health     as the main health promotion topic. Group 2 will receive educational curriculum pertaining to     the topic of iron deficiency prevention. While pediatricians are positioned perfectly to     partner and effectively communicate with families on these two issues, there are gaps in     pediatric education addressing these topics. The CORNET continuity practices of the     Ambulatory Pediatric Association provide a venue through which multiple residency programs     that educate pediatric residents and whose residents provide medical care to underserved     children can participate. The research hypotheses include:        1. Residents in Group 1 will have greater confidence, knowledge and competence in          partnership building and communication with families        2. Residents in Group 1 will have greater knowledge and competence in discussing oral          health promotion        3. Residents in Group 2 will have greater knowledge and competence in discussing iron          deficiency prevention        4. Parent-child dyads in Group 1 will be more likely to have established a dental home        5. Parent-child dyads in Group 1 will be more likely to be satisfied with their healthcare          encounter.      Pediatric practices provide fertile ground for the provision of health promotion on oral     health and iron deficiency prevention. However, evidence for the effectiveness of primary     care clinician interventions of screening, referral and counseling to prevent dental caries     is lacking [14]. The National Survey of America's Families [15] found 47% of children did not     receive the recommended number of dental visits, with the youngest ones being least likely to     receive any dental care.      Although 90% of pediatricians agreed they had important roles in identifying and counseling     patients on prevention of caries, half stated they had received no previous training during     medical school or residency and their knowledge of basic oral health topics was limited [13].     These studies highlight that pediatricians play important roles in oral health and are     capable of being trained to complete oral screening exams, but more education and guidance is     needed.      Iron deficiency is the most common childhood nutritional deficiency in the United States.     Recent prevalence data have determined that 7-30% of children in the United States aged 1-2     years have iron deficiency and 3-10% have iron deficiency anemia [17, 18]. Specific goals in     Health People 2010 include a reduction of iron deficiency to 5% in children less than 3 years     of age.   "
143479|NCT01406353|"     Although percutaneous mitral commissurotomy (PMC) has been accepted as an effective treatment     for symptomatic patients with moderate or severe mitral stenosis (MS), most asymptomatic     patients are not candidates for PMC owing to the small but inherent procedure-related risks.     Asymptomatic patients with MS show good survival rates up to 10 years, but there was a sudden     deterioration precipitated by atrial fibrillation or embolism in half of the patients.     Because the success rates of PMC were improved to more than 95% in ideal patients from highly     selected centers and early PMC may decrease the occurrence of adverse events, such as atrial     fibrillation or embolism, experienced centers tend to perform PMC at an early stage of     disease. However, the potential benefits of early preemptive PMC in asymptomatic patients     should be balanced against the real risks related to the procedure, and further studies of     the efficacy of PMC in the prevention of embolism are necessary to extend its indications to     asymptomatic patients. To the best of our knowledge, No randomized trials have been performed     to ascertain the optimal timing of intervention in asymptomatic patients with significant MS.     The early percutaneous MITral Intervention versus conventional manaGement in Asymptomatic     moderate miTral stEnosis (MITIGATE) trial was designed to compare clinical outcomes of early     intervention with those of a conventional management based on current guidelines in     asymptomatic moderate mitral stenosis.   "
143480|NCT01406340|"     This will be an open-label, parallel-group study to evaluate the pharmacokinetics of     GSK1278863 and metabolites in normal subjects and subjects with impaired renal function,     including those who are hemodialysis dependent. GSK1278863 will be administered once daily     for 14 days to normal subjects and subjects with Stage 3 and Stage 4 renal function, and 15     days to subjects with Stage 5 renal function. Pharmacokinetic assessments will be made on     Days 1 and 14 (normal subjects, subjects with Stage 3 and Stage 4 renal function) or Days 14     and 15 (dialysis and non-dialysis days; Stage 5).   "
143481|NCT01406327|"     The objective of this post-marketing surveillance study is to evaluate the incidence of     adverse events in Japanese subjects with pulmonary arterial hypertension treated with     ambrisentan basd on prescribing information under the conditions of general clinical practice     and also to grasp the following items;        1. Unknown adverse drug reactions (ADRs)        2. Incidence of ADRs to medical products in actual clinical practice        3. Factors influencing safety of ambrisentan        4. Factors influencing efficacy of ambrisentan        5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use          (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)   "
143482|NCT01406314|"     This study aims to provide safety information on the ligand, GSK2315698A. The     pharmacokinetics and pharmacodynamics of the ligand will be determined together with the     differences in routes of dose administration, namely the tolerability between intravenous     versus subcutaneous dose administration. The study will be carried out in patients with     systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid     protein (SAP) will be measured.   "
143483|NCT01406301|"     Fondaparinux, a synthetic and specific factor Xa inhibitor, was granted an ACS indication by     Health Canada in March 2007 and by the EMEA in September 2007. Among ACS patients,     fondaparinux is indicated for the treatment of UA/NSTEMI in patients for whom urgent PCI     (within 2 hours) is not indicated, and for the treatment of STEMI in patients who are managed     with thrombolytics or who are initially to receive no other form of reperfusion therapy. The     approved prescribing information for fondaparinux in ACS provides recommendations for use in     patients undergoing PCI. The purpose of this study is to evaluate physician adherence to this     prescribing information in ACS patients treated with fondaparinux and who undergo PCI. The     primary endpoint is the proportion of patients with ACS treated with fondaparinux, for whom     the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy     administered at the time of PCI). Measurement of the effectiveness or safety of fondaparinux     use in ACS patients is not within the scope of this study.      ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.   "
143484|NCT01406288|"     The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection     with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype. An     outbreak of bloody diarrhea followed by HUS begun after a collective meal with 120 persons on     June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).      At least 9 patients, 8 adults and 1 child have been involved in this HUS outbreak, E. coli of     the O104:H4 serotype being demonstrated in most patients. This outbreak is remarkable by its     preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e. the     kidneys, brain, liver, pancreas, and skin.      Pathophysiology, prognosis, and treatment of typical HUS are poorly defined, particularly in     adults who are usually not involved in typical E. coli O157H7 HUS.      The aim of the present study is to gain knowledge on these different aspects of the HUS,     including response to therapy.   "
143485|NCT01406275|"     This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the     information on proper use, such as safety and efficacy, under actual use conditions,     targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin     infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis,     tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.      (CLAVAMOX is a trademark of the GlaxoSmithKline group of companies.)   "
143486|NCT01406262|"     This study is designed to investigate the effect of treatment with albiglutide on the cardiac     repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a     positive control, or moxifloxacin placebo will be given in order to validate the ability of     the study to detect a change in the corrected QT interval.   "
143487|NCT01406249|"     The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line     treatment of Advanced Gastric Cancer.   "
143488|NCT01406236|"     The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI,     transradial PCI will result in a significant reduction in bleeding and vascular     complications. The primary objective is to compare the efficacy and feasibility of the     transradial approach to percutaneous coronary intervention (PCI) in women compared with the     transfemoral approach.      This study is a multicenter, randomized, open-label active controlled study. Three thousand     women undergoing urgent or elective PCI from at least 50 centers will be randomized to either     transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI     will be randomized before diagnostic angiography. A total of approximately 3000 women will be     randomized to obtain a cohort of approximately 1800 patients undergoing PCI.      The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our     trial is very low, making it unlikely that there will be statistical power to show a     difference between the randomized arms in the SAFE PCI for Women study using the BARC     bleeding definition per protocol. Based on this statistical futility, the DSMB has     recommended stopping enrollment. They also noted, however, that as this is not based on any     safety issues, and since there are a variety of key secondary endpoints (contrast and     radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB     left it to the discretion of the Steering Committee to continue enrollment to meet sufficient     power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these     issues and voted to continue enrollment until the planned sample size for the Quality of Life     substudy was met (300 patients).   "
143489|NCT01406223|"     The purpose of this study is to look at brain function in order to understand how different     treatments work to help people quit smoking. In this study, the investigators will look at     the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.   "
143490|NCT01406210|"     The purpose of the prospective study is to collect information surrounding lung transplant in     order to develop a randomized study to determine if prevention of gastroesophageal reflux     disease (GERD) related aspiration (stomach acid coming up from the stomach into the     esophagus) by surgical fundoplication improves lung rejection. Lung transplantation has     evolved into an effective treatment for patients with end-stage lung disease; however, a     significant limitation to long-term survival is patients develop a condition of scarring     known as chronic lung rejection, which can cause lung function to deteriorate, thereby     reducing a patient's chances for survival. Preliminary research has shown a correlation     between the presence of gastroesophageal reflux disease (GERD) and impaired early lung     rejection as assessed by a breathing test, FEV1 (the amount of forced expired air volume in 1     second).      The Investigator is interested in learning more about this condition and the potential for     aspiration (inhaling fluid) injury. The primary goal of this preliminary study will be to     identify aspiration markers that are correlated with adverse clinical outcomes (increased     early rejection, decreased FEV1) that may be used as inclusion criteria for the future     randomized trial.      The purpose of the retrospective study is to collect information surrounding lung transplant     in order to develop a randomized study to determine if prevention of gastroesophageal reflux     disease (GERD) related aspiration (stomach acid coming up from the stomach into the     esophagus) by surgical fundoplication improves lung rejection.      The goal of this retrospective data collection is to review the following:        1. subject outcome event rates for subjects with and without gastroesophageal reflux          disease (GERD) for survival, Bronchiolitis Obliterans Syndrome (BOS), acute rejection          and Forced Expiratory Volume in the first second (FEV-1),        2. the estimated treatment effect of fundoplication on the above event rates,        3. a threshold effect for Bronchiolitis Obliterans Syndrome (BOS) and/or death are more          likely to occur at higher or more proximal acid or non-acid contact times.      This data will be collected in order to better design and coordinate a multicenter     prospective study.   "
143491|NCT01406197|"     This study will examine the effects of various formulations of progesterone on uterine     electromyographic (EMG) activity in pregnant patients in premature labor to determine if     progesterone will suppress uterine electrical activity and which formulation may be best for     inhibition of uterine activity. Patients will be monitored prior to treatment and following     treatment (every 2 to 4 hours) with one of three different formulations of progesterone for     up to two days. Patients will continue to be observed until they deliver. Comparisons will be     for uterine EMG activity from before treatment to that following treatments at 2, 4, 8, 12 24     and 48 hours and times of delivery after treatments (hours or days following treatments).     Comparisons between mean values for EMG activity between the various treatments at the     various times will also be made.   "
143492|NCT01406184|"     The aim of this randomized controlled trial (RCT) is to evaluate the impact and mechanisms of     the Durham Connects (DC) brief universal nurse home-visiting program to prevent child     maltreatment and improve child well-being. It is the first-ever RCT of a home-visiting     program that is designed to prevent child maltreatment in an entire community population.      Evaluation of program impact will test three hypotheses: 1) Random assignment to the Durham     Connects Program will be associated with lower rates of child maltreatment and emergency     department maltreatment-related injuries, better pediatric care, better parental functioning,     and better child well-being than assignment as control; 2) Intervention effect sizes will be     larger for higher-risk groups; and 3) Community resource use and enhanced family functioning     will mediate the positive impact of Durham Connects on outcomes.   "
143493|NCT01406171|"     The purpose of this study is to determine the effect of isavuconazole at steady state on the     pharmacokinetics of midazolam in healthy adult subjects.   "
143494|NCT01406158|"     A study in healthy volunteers comparing two different liquid formulations of solifenacin with     each other and with the tablet formulation.   "
143495|NCT01406145|"     This study is intended to determine the safety and tolerability of ASP0777 in subjects with     Alzheimer's Disease (AD) taking a stable dose of donepezil.   "
143496|NCT01406132|"     The objective of this study is to evaluate pharmacokinetics, in particular the routes of     excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled     ASP015K.   "
143497|NCT01406119|"     This is an extension study of ABT-806 for subjects with advanced solid tumors.   "
143498|NCT01406106|"     Background information Studies have been conducted on supplementing the daily diet with plant     sterol ester-enriched milk derivatives in order to reduce LDL-cholesterol levels and,     consequently, cardiovascular risk. However, clinical practice guidelines on     hypercholesterolaemia state that there is not sufficient evidence to recommend their use in     subjects with hypercholesterolaemia. The null hypothesis establishes that there is no     relationship between the decrease in blood LDL-cholesterol levels and the consumption of     stanol ester enriched liquid yoghurt. The alternative hypothesis establishes a relationship     between such consumption and the incidence of the primary variable.      The main objective of this study is to determine the efficacy of the intake of 2 g of plant     sterol esters a day in lowering LDL-cholesterol levels in patients diagnosed with     hypercholesterolaemia. The specific objectives are: 1) to quantify the efficacy of the daily     intake of plant sterol esters in lowering LDL-cholesterol, total cholesterol and     cardiovascular risk in patients with hypercholesterolaemia; 2) to evaluate the occurrence of     adverse effects of the daily intake of plant sterol esters; 3) to identify the factors that     determine a greater reduction in lipid levels in subjects receiving plant sterol ester     supplements.      Study design Randomised, double-blind, placebo controlled experimental trial carried out at     family doctors' surgeries at three health centres in the Health Area of Albacete (Spain). The     study subjects will be adults diagnosed with limit or defined hypercholesterolaemia and     who have LDL cholesterol levels of 130 mg/dl or over. A dairy product in the form of liquid     yoghurt containing 2 g of plant sterol ester per container will be administered daily after     the main meal, for a period of 24 months. The control group will receive a daily unit of     yogurt not supplemented with plant sterol esters that has a similar appearance to the     enriched yoghurt. The primary variable is the change in lipid profile at 1, 3, 6, 12, 18 and     24 months. The secondary variables are: change in cardiovascular risk, adherence to the dairy     product, adverse effects, adherence to dietary recommendations, frequency of food     consumption, basic physical examination data, health problems, lipid-lowering medication,     physical activity, smoking habits and socio-demographic variables.   "
143499|NCT01406093|"     A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted     antifungal therapy. In the last years a growing body of knowledge has better characterized     health-care associated (HCA) infections, which have been described in 2002 in outpatients     with MRSA bloodstream infections. So far there is no compelling evidence that patients with     HCA infections may develop candidemia before the usual timing of around 20-25 days after     admission. Risk factors associated with HCA infections are represented by admission from long     term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad     spectrum antibiotics. There are few data HCA features and early onset candidemias in the     published literature.      In this proposal, the investigators aim at studying early-onset candidemia in a retrospective     study in one of the largest referral hospital in Italy with a consistent range of specialties     ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU,     complex surgery). The investigators speculate that patients with candidemia diagnosed within     10 days (early-onset) by the admission have different risk factors and prognosis of those     with a late diagnosis.   "
143500|NCT01406080|"     The purpose of this study is to:        1. Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream 0.05%,          reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation,          investigator evaluation of global response to treatment and subject's evaluation of          improvement.        2. Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin          Emollient cream 0.05% during 24 weeks of treatment.      The study has the clinical hypothesis that Adapalene Gel 0.3% is as effective as Tretinoin     Emollient cream 0.05% in the treatment of cutaneous photoaging.   "
143501|NCT01406067|"     The efficacy of the Treatment Program for Children with Aggressive Behaviour     (Therapieprogramm für Kinder mit aggressivem Verhalten, THAV) which is a social competence     training delivered in an individual format will be evaluated in a randomized controlled trial     with children aged 6 to 12 years with peer-related aggressive behaviour.   "
143502|NCT01406054|"     Sports-related injuries are a serious concern for physically active children and adolescents.     Previous research, including ours at Chicago public high schools, shows our neuromuscular     training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries     in female athletes by up to 88%. However, KIPP is not well-studied in males or younger age     groups. This project aims to determine KIPP's effect on sports-related injuries and physical     fitness among 5th-8th grade students in Chicago public schools. The study will take place     during the 2011-2013 school years. To measure KIPP's effect on sports injuries, we will     recruit 5th-8th grade sports coaches and their athletes, randomize coaches by school into two     groups, then train the intervention group to implement a 10-minute KIPP warm-up before     practices and games. Control group will perform their usual warm-up. Research assistants will     collect athlete participation and injury data from coaches weekly. To determine feasibility     of KIPP in PE classes and measure its effect on fitness, we will recruit PE teachers to     implement the warm-up in PE classes for a minimum of 10 weeks, and record students'     presidential fitness test scores before and after the 10+ weeks. Results of this study will     guide strategies for preventing sports-related injuries and improving physical fitness in 5th     -8th graders.   "
143503|NCT01406041|"     The fluid and electrolyte imbalance (FEI) is pretty common encountered during the clinical     process of patients suffered sellar lesions. Moreover, if the patients are undergone the     surgery for remove the lesion, FEI happens in all cases without exception. Hypo- and     hyper-natremia is the most common electrolyte disorder, which is directly correlated to the     patients' outcome. However, in clinical works, different sellar diseases cause variant     features of FEI. For example, after the surgery of craniopharyngioma, the hyponatremia and     hypernatremia always happen alternatively even without any precursor manifestation. Under     this situation, it is quite difficult for fluid supplement. In contrast, the severe FEI will     cause poor outcome, even death. So it is necessary to systematically collect and review the     clinical data of sellar lesions. Through the analysis of variant FEI patterns of sellar     diseases, more precise strategy for clinical fluid replacement will be proposed.   "
143504|NCT01406028|"     In vitro fertilization for infertility has been associated with a significant amount of     treatment related stress for patients. In addition,stress levels increase between embryo     transfer and pregnancy test, during this waiting period. The investigators evaluated whether     or not brief interventions by phone by trained social workers influenced stress levels. Our     data showed that these interventions did not change levels, but confirmed that stress did     increase during this time and that patients report wanting additional emotional support to     improve stress during this period.   "
143505|NCT01406015|"     The purpose of this study is to find out if spironolactone, a drug that blocks the action of     aldosterone, can make the blood vessels work better in people with obesity. The investigators     also want to find out whether spironolactone causes changes in levels of insulin and markers     of inflammation.   "
144127|NCT01397890|"     This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV     design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva     compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease     (COPD).   "
143508|NCT01405976|"     Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus     continuous positive airway pressure (CPAP) and the historic treatment (weight loss and     oxygen) in Obesity Hipoventilation Syndrome (OHS), with PCO2 and days of hospitalization     analyzed as a primary variables and percentage of dropouts for medical reasons and mortality     as operative variables. As secondary variables: Measure functional and clinical improvement     during sleep and wakefulness, quality of life, and the incidence and evolution of     cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular     inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective,     randomized controlled trial. Patients with OHS will be divided initially into two groups     based on their apnea-hypopnea index (AHI) score, >=30 and < 30, using conventional     polysomnography. The AHI >=30 group will be randomized to CPAP, NIV or historic treatment.     The AHI <=30 groups will be randomized to NIV or historic treatments. Treatment efficacy at     the medium- and long-term will be analyzed by comparing groups. The role of apneic events and     leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the     daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the     evolution of leptin levels in the four branches of the study. The role of apneic events in     metabolic and biochemical alterations and endothelial dysfunction will be analyzed by     comparing basal and post-treatment levels of related substances between groups, with and     without significant AHI.   "
143509|NCT01405963|"     The purpose of this study is to assess the late asthmatic response, safety and tolerability     of AMG 157 following multiple intravenous (IV) dose administration in subjects with mild     atopic asthma.   "
143510|NCT01405950|"     A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety     and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in     Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.   "
143511|NCT01405937|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir     given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin     (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous     therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage     of participants achieving sustained virologic response 24 weeks after completion of all study     therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is     greater than 20% (historical data of standard of care treatment).   "
143512|NCT01405924|"     This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant     (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3     antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting     (CIV) in participants who experienced CIV in the first cycle of moderately emetic     chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching     in at least 20% of participants during the second cycle of MEC in participants who previously     experienced vomiting during the first cycle of MEC.   "
143513|NCT01405911|"     This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin     (MK-0431/ONO-5435) used once daily (qd) for Japanese subjects with impaired glucose tolerance     who have inadequate glycemic control using diet and exercise therapy.   "
143514|NCT01405898|"     We are interested in the effect of diet on blood pressure. Our previous research has shown     that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot     juice has this effect in people with high blood pressure. Beetroot juice is naturally rich in     nitrate (also found in most other vegetables but particularly in green leafy vegetables). We     think that it is the nitrate that lowers the blood pressure.   "
143515|NCT01405885|"     This is a Phase I, parallel design open label study to evaluate safety, tolerability and     immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid     administered intradermally followed by electroporation in healthy adults   "
143516|NCT01405872|"     The primary objective of the study is to determine physician reported persistence with the     Avonex PEN at Month 12/End of Study as well as determining factors associated with     persistence. The secondary objectives for this study are as follows: To evaluate the     tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To     evaluate patient quality of life (QoL) while using the Avonex PEN for treatment     administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the     Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection     procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence     at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate     overall patient satisfaction with the use of the Avonex PEN for treatment administration at     Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12;     and To evaluate the percentage of patients switching from caregiver to self-injection at     Months 3, 6, and 12.   "
143517|NCT01405859|"     Doctors provide a ray of hope to children and their parents with the knowledge that, for most     patients, symptoms of Tourette syndrome improve by the time they are young adults. The     investigators do not know why some improve and others do not. This study is designed to help     answer that question. The investigators will use magnetic resonance imaging (MRI) techniques     to test whether individuals who experience improvement of their Tourette's (tic remission)     have more mature brain connections than those who do not.   "
143518|NCT01405846|"     We are going to use a special type of bronchoscopy test to examine patients who have had     previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine     a) whether we can identify precancerous changes in their airways b) whether this type of     testing is acceptable and c) get an initial idea of whether a new drug called gefitinib has     any effect on precancerous areas in the airway.   "
143849|NCT01401517|"     Sodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound     healing and prevent tissue necrosis in animals. Since patients with PAD experience many of     these problems, this study will seek to determine whether this drug, when given orally, could     provide the same benefits to patients with PAD.   "
144484|NCT01393236|"     Based on prior findings concerning sleep disturbances, in particular REM sleep disturbances,     after fast-track hip and knee arthroplasty (H-2-2010-011) we performed a supplemental     analysis of heart rate variablity after arousals during sleep. We compared preoperative and     postoperative results.   "
143519|NCT01405833|"     The primary objective of the study is to evaluate the safety, tolerability, and     pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed     schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).      Secondary objectives of this study in this study population are to explore the repeated-dose     immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following     multiple-dose administration.   "
143520|NCT01405820|"     The primary objective of this study is to explore the effects of multiple regimens of     natalizumab on disease activity and safety in participants with relapsing-remitting Multiple     Sclerosis (RRMS).   "
143521|NCT01405807|"     Overview:      This open label, randomized, multi-centre study will enroll and treat 24 patients with     refractory AAV.      Aims:      To determine the clinical response and severe adverse event rates associated with alemtuzumab     therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV).      Hypothesis:      Treatment with alemtuzumab induces sustained remission in AAV and will reduce     immunosuppressive and steroid exposure.   "
143522|NCT01405794|"     The investigators propose to study oral commercial silver nanoparticle products on human     enzyme activity.   "
143523|NCT01405781|"     The objective of this study is twofold: First, to determine whether higher levels of     pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff     repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function,     Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically     examine and perform a radiographic analysis of patients at a minimum of 6 months after     reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic     scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator     cuff repair.   "
143524|NCT01405768|"     Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for     their cervical block will experience less injection pain than women who receive plain     lidocaine.   "
143525|NCT01405755|"     Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight     in young children. In Mexico, breastfeeding extends well into the second half of infancy, but     animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo.     This study evaluates whether knowledge and practices about dietary diversity and food     consistency can be improved using a two-component intervention strategy in semi-urban     communities in Mexico. The two components will deliver appropriate complementary feeding     messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio     messages and interviews. The intervention is evaluated using a cluster randomized design in     small semi-urban communities in two states in Mexico with pre- and post-test questionnaires     designed to assess changes in feeding behaviors.   "
143526|NCT01405742|"     The purpose of this pilot R34 trial is to determine the feasibility of a large single dose     Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly     recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint     range of motion, cost, quality-of-life, F.VIII level, and inter-dose hypocoagulability by     thrombin generation. Safety will be measured by inhibitor formation and bleeding events     unresponsive to up to two rescue doses.   "
143527|NCT01405729|"     The purpose of this retrospective study was to determine the accuracy of femoral tunnel     placement utilizing Redfern et al's radiographic method for anatomic femoral attachment     during MPFL reconstruction in addition to the resultant outcome.   "
143528|NCT01405716|"     The primary objective of this study is to determine the effectiveness of a mind-body program     in increasing function and reducing pain among older adults with chronic low back pain   "
143529|NCT01405703|"     This is a prospective, level II evidence comparison between two cohorts. This study is     designed to compare the percutaneous versus open approach for plate fixation of diaphyseal     clavicle fractures. This study includes questionnaires and measurements that will collect     data on incision-related numbness, union rates, overall outcomes, complication rates of the     two methods, infection rates, and overall satisfaction. The surgical procedure, all     radiographs and follow-up visits to a minimum of one year are the principle investigators     (PI's) standard of care for this injury. Measurements and questionnaires are related to the     study.   "
143530|NCT01405690|"     Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to     assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the     detection of coronary artery disease is on the rise, the current technology of the 64-row     multidetector computer tomography (MDCT) is subjected to multiple patient artifacts that can     affect image quality.To eliminate these patient related artifacts a more advanced 320-row     MDCT was recently developed. The investigators therefore propose that the newly developed     320-MDCT can provide an accurate noninvasive assessment of the severity of coronary artery     luminal stenosis as an alternative to an invasive coronary angiogram.   "
143531|NCT01405677|"     The primary purpose of the original study was to assess whether the protection afforded by     the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection     afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a     computer based modelling analysis of the long term protection afforded by the paediatric     dose, and to compare this with the standard dose and also with an alternative hepatitis A     vaccine (Havrix Junior).   "
143532|NCT01405664|"     The rationale for this research study is to evaluate the effect on clinical outcomes of     weight bearing as tolerated after forage surgery for the treatment of osteochondral defects     of the ankle, thus potentially eliminating the need for a period of immobilisation or     non-weight bearing after surgery.      The investigators hypothesize that their will be no difference in functional outcomes between     weight bearing as tolerated as compared to non-weight bearing for six weeks after forage     surgery for OCD of the ankle.   "
143533|NCT01405651|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-6950     across ascending multiple doses in healthy adult male and female subjects. The secondary     objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by     measuring plasma concentrations of ONO-6950 and pulmonary function.   "
143850|NCT01401504|"     A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced     malignancies (solid tumors).   "
143534|NCT01405638|"     Primary Aim: To evaluate the effect of a lifestyle intervention delivered through     telephone-based motivational interviewing (MINT) versus a patient navigation intervention on     blood pressure reduction and CRC screening.      Hypotheses: Among black men, aged > 50 years with uncontrolled HTN and in need of CRC     screening:        1. Hyp. 1: those randomized to the lifestyle intervention will have lower BP compared to          those randomized to the patient navigation intervention at 6 months.        2. Hyp. 2: those randomized to the patient navigation intervention will have higher CRC          screening rates compared to those randomized to the lifestyle intervention at 6 months.   "
143535|NCT01405625|"     Asthma has an especially great impact on poor urban children and their families. In addition     to higher asthma prevalence and morbidity, those in low SES urban areas are at risk for low     health literacy. Low health literacy is associated with poorer asthma outcomes. The provision     of a written asthma action plan has been shown to help with asthma management and to reduce     hospitalizations and ER visits. Poor urban families who may have low literacy may need an     alternative asthma action plan to convey the treatment plan.      This pilot study proposes to investigate whether a plain language asthma action plan can     improve parent understanding and adherence with medication instructions, compared to standard     written materials, among parents of children with asthma. This is an RCT in which parents of     children with asthma will be randomized to either receive a pictogram-based low literacy     asthma action plan, or a standard action plan (AAAAI), to examine whether those who receive     the low literacy plan have improved asthma action plan knowledge when presented with a     hypothetical scenario.      A second part of the study is to examine whether providers who are given the pictogram-based     low literacy asthma action plan will be more likely to counsel about certain aspects of     asthma management (eg. need for daily medications even when sick, spacer use, confusion     between everyday and rescue inhaler)compared to providers who receive use a standard action     plan (AAAAI). This is an RCT in which pediatric providers are randomized to counsel a     hypothetical patient using the pictogram-based action plan or the standard action plan     (AAAAI).   "
143536|NCT01405612|"     An open-label, single centre, randomised, cross-over study to examine the effect of     ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of     ulimorelin in healthy volunteers.   "
143537|NCT01405599|"     Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a     single intravenous (IV) dose in order to identify potential patients at risks in terms of     severity of hepatic dysfunction and to determine whether their dosage should be adjusted.   "
143538|NCT01405586|"     The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy     with gemcitabine in elderly patients with non small cell lung cancer in terms of overall     survival.   "
143539|NCT01405573|"     The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best     supportive care with best supportive care alone in terms of survival in patients with     hepatocellular carcinoma (HCC) with impaired liver function (Child B).   "
143540|NCT01405560|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir     (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and     ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who     have not responded to previous treatment. The primary efficacy objective is to estimate     efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of     participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks     after completion of all study therapy (Sustained Viral Response 24 [SVR24]).   "
143541|NCT01405547|"     Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in     life. Recent evidence indicates that abnormalities that increase risk for diabetes may be     initiated early in infancy. Since the offspring of women with diabetes have an increased     long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic     abnormalities on early nutrition and infant metabolic trajectories is of considerable     interest. The purpose of the study is to investigate the impact of maternal nutrition and     metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the     first year of life.   "
143542|NCT01405534|"     It is an observational, prospective, monocentric study. The purpose of the study is to assess     the acute complications rate caused by a central venous catheter placement.      All the patients who require a central venous placement could be enrolled in the study.      The study will not change the usual practice. The placement will be on day 1 and patients     will be contacted by phone on day 7 to identify potential complications and to assess pain.      Anaesthesia staff will keep patients under surveillance to control the absence of late     complications.   "
143543|NCT01405521|"     Using an established model of human typhoid infection, whereby healthy adults are     deliberately infected with typhoid-causing bacteria, the investigators will determine how     effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously     licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used     works properly.   "
143544|NCT01405508|"     This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety     and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with     epilepsy according to an initiation or a conversion scheme, during repeated dosing (100     mg/administration twice daily for 4.5 days).   "
143545|NCT01405495|"     The goal of this study is to identify the early modifications in fronto-temporal connectivity     in female victims who developed PTSD, compared to female victims who did not develop the     disorder, and to healthy control females. The investigators will compare between all these     groups, structural and functional differences using different techniques (MRI, fMRI, DTI and     ASL), and paradigms (cognitive tasks or at rest).   "
143546|NCT01405482|"     Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the     irritation on the neurovascular structures at the interscalene triangle in subjects with TOS.     This will lead to reductions in pain and paresthesias, and improvements in function when     compared with injection of placebo.   "
143547|NCT01405469|"     This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic     myotomy for the treatment of achalasia in a single center setting in Europe.   "
144201|NCT01396928|"     The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is     able to improve functional results and quality of life after coloanal anastomosis.   "
143548|NCT01405456|"     The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle     modification to affect sugar metabolism, body fat distribution, and cardiovascular health in     HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that     aldosterone, a hormone that regulates salt and water balance, is increased in association     with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals,     aldosterone appears to be higher in individuals with increased belly fat, and increased     aldosterone appears to be strongly associated with impaired sugar metabolism. In this study,     the investigators will test the effects of eplerenone, which is a medication that blocks the     actions of aldosterone, along with lifestyle modification. The investigators hypothesize that     eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce     fat accumulation in liver and muscle.   "
143549|NCT01405443|"     This is a randomized controlled trial evaluating three training intervals using an endoscopy     simulator for novices and comparing performance after training.   "
143550|NCT01405430|"     It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess     the predictive value of VE-cadherin on the objective tumor response.      Biological factors will be correlated to clinical outcome measures.      100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be     enrolled.      Patients will be followed every 10 weeks until progression in spite of bevacizumab or until     they stop bevacizumab because of toxicity.      Bevacizumab will be administered according to investigators appreciation.      Blood samples will be collected at enrollment, at second bevacizumab's administration and     every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or     until one year at most in case that patients still receive bevacizumab.   "
143551|NCT01405417|"     This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic     myotomy for the treatment of achalasia in a multi center setting.   "
143552|NCT01405404|"     The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on     increasing parent participation rates in a preventive parent training program called the     Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the     Chicago Parent Program in childcare centers serving low-income families with young children.   "
143553|NCT01405391|"     Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose     (RD) of PM01183.   "
143554|NCT01405378|"     Every five minutes someone in the UK has a stroke. It is the main cause of long-term     disability among adults in the UK despite a fall in age-specific stroke incidence, with a     growing number of survivors remaining dependent for activities of daily living. While most     people with stroke regain walking ability, upper limb problems with no voluntary arm and hand     activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct     current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through     the application of weak direct currents and has the potential to develop into a useful aid to     treatment strategies in neurorehabilitation. Recent literature into the application of tDCS     in people with arm and hand impairments after stroke has shown promising results on upper     limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot     study evaluated a six-week training programme combining tDCS with robot-assisted hand     training and reported significant improvements in upper limb function. However, the robot in     the latter study focused on single-plane distal movements only and long-term effects of the     tDCS were not assessed. Recent robotic developments included robots with three rotational     degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined     with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES     Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.   "
143555|NCT01405365|"     The purpose of this study is to investigate the effect that obesity may have on the     nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive     periodontal diseases (chronic periodontitis).   "
143556|NCT01405352|"     In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4     month supplementation of vitamin A will be compared with placebo intaking group.   "
143557|NCT01405339|"     Budesonide, a steroid subtype, has been used as an adjunctive treatment for chronic     rhinosinusitis as a topical nasal steroid spray. The current standard of care at St. Paul's     Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). It is     believed that the MAD is a better device than the standard nasal lavage because its fine mist     enhances absorption and improves bioavailability. No studies have been done to determine if     enhanced absorption and improved bioavailability of budesonide via MAD could potentially     affect the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the suppression of our own     body's production of natural steroids.   "
143558|NCT01405326|"     The purpose of the study is to assess whether a 6-month treatment with adalimumab added on     the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days     on sick leave compared to placebo. In addition, the cost-effectiveness and cost-utility of     the intervention compared to the conventional treatment is evaluated, and the patients who     benefit most are characterized.   "
143559|NCT01405313|"     This study will determine if modified adaptive servoventilation (ASV) is as effective as the     conventional ASV in treating periodic breathing. The study will determine if the modified ASV     reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive     airway pressure compared to conventional ASV.   "
143560|NCT01405300|"     Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and     insulin response when incorporated into an acute high fat/high glucose meal. However, it is     unclear whether acute consumption of peanuts can also influence vascular function. This study     will therefore evaluate the effects of acute peanut consumption on vascular function,     glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a     high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve     endothelial function as measured by flow-mediated dilation (FMD).   "
143695|NCT01402505|"     This is a prospective chart review/data collection study of natural orifice translumenal     endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires     administered throughout the study. Subjects enrolled will be those intending to have a     transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months     post-op.   "
143561|NCT01405287|"     OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after     deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered     Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo     native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in     length.      STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed     to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent     versus the commercially available everolimus eluting stent (Xience V or Promus). Patients     will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA)     follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180,     360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all     participants of the study.   "
143562|NCT01405274|"     This study will investigate whether adding a physiotherapy intervention to standard Emergency     Department care will lead to improved recovery following an ankle sprain in the pediatric and     adolescent population as well as to a decrease recurrence of injuries during the year     following the initial ankle sprain. Children will be allocated to standard care or to the     added intervention group. The study hypothesis is that recovery will be better while     recurrence of injury will be less in those receiving the added physiotherapy intervention.   "
143563|NCT01405261|"     This trial is conducted in Europe. The aim of this trial is to investigate safety,     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single     doses of NNC 0113-0987 in healthy male subjects.   "
143564|NCT01405248|"     The purpose of this study is to determine whether butylphthalide are effective for Preventing     Restenosis after Intracranial and Extracranial Artery Stenting   "
143565|NCT01405235|"     Current planning for studies involving patients with recurrent, persistent, or metastasized     cervical cancer must take into consideration that up to 75% of all patients are assumed to     have already been treated with cisplatin in conjunction with radiation therapy. It seems     questionable to continue to treat patients with cisplatin when cancer has recurred. Thus, it     is important to seek alternative active combinations. The studies GOG 169 and 179     demonstrated that a combination of paclitaxel and cisplatin was superior to a cisplatin     monotherapy with respect to therapeutic response and progression-free survival, as was a     combination of topotecan and cisplatin with respect to therapeutic response, progression-free     survival, and total survival. To achieve further improvement in total survival and to answer     questions regarding the value of using a platinum-free combination, we propose that a study     should be conducted to compare the efficacy of a platinum-free combination of paclitaxel and     topotecan to a combination of cisplatin and topotecan.   "
143566|NCT01405222|"     Acute exacerbations of COPD remain a common cause of morbidity and are associated with a     sustained increase in the normal respiratory symptoms of dyspnoea, cough, and sputum volume     and purulence. It has previously been shown that a change in cough symptoms occurs in 51.7%     of exacerbations in COPD. We wish to record cough during a COPD exacerbation to determine     whether this can be a objective marker of exacerbation duration and severity.   "
143567|NCT01405209|"     Atrial fibrillation (AF) is the most common arrhythmia, affecting 1% of adults, with its     prevalence increasing with age [1]. It is associated with increased morbidity and mortality.      Most patients who develop AF have architectural and anisotropic micro changes in the atrial     myocardium. These cause heterogeneous and discontinuous changes in the patterns of impulse     propagation, heterogeneous atrial activation and shortening of atrial refractory period [2,     3].      Since 1911 the standard EKG [4] (approximately 15 seconds of recording and bandwidth 0.05 to     150 Hz) is the most used tool for the evaluation of patients with arrhythmias, due to its low     cost and high availability. Various electrocardiographic patterns are known predictors of AF     as evidenced by direct visual inspection. For example, prolongation of P wave duration during     sinus rhythm would correlate with structural changes such as increasing the size of the left     atrium (the increase in left atrial pressure) or a decrease in driving time [5]. These     changes favor the development of reentry circuits responsible for the development and     maintenance of AF.      The registration of the electrocardiographic activity provides much more information than     evidenced by direct visual inspection. Biosignal processing of these specific techniques to     detect potential delays caused by abnormal conduction of the myocardium that favor re-entry     mechanisms [6-10]. For this purpose prolonged ECG with 1000 Hz sampling frequency. Knowledge     about the prediction of the development of AF with the standard ECG is not obvious on visual     inspection is limited.      Many of these structural changes and anisotropic, occur slowly over time and may be evidenced     by direct variations between 2 ECG from the same individual [11]. Little is known about     whether differences in morphology, axis, scope or duration of P wave related to these     structural changes may predict the development of AF.      Our main purpose is to evaluate the prognostic performance of a set of parameters as     evidenced by direct inspection of the ECG, and ECG changes from 2 to predict the FA     development. The design of this tool could allow future generation of software capable of     identifying and reporting these variations, most useful prognostic risk in patients with AF.   "
143568|NCT01405196|"     The objective of this study is to evaluate and compare efficacy of 3 dose levels of     PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic     Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory     measures as well.   "
143569|NCT01405183|"     The purpose of this study is to determine if there is an association between hepatitis C     infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will     either have a biopsy or surgery will be offered to be tested for hepatitis C. The control     group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).   "
143570|NCT01405170|"     A study to determine whether a new formulation of methylprednisolone suspension is     bioequivalent to methylprednisolone tablets under fed conditions.   "
143571|NCT01405157|"     A study to determine whether a new formulation of methylprednisolone suspension is     bioequivalent to methylprednisolone tablets under fasting conditions.   "
143572|NCT01405144|"     It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic     keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging     while treating Aks was reported.      The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU     use for forearms photoaging.   "
143573|NCT01405131|"     A study to determine whether a new formulation of methylprednisolone suspension is     bioequivalent to methylprednisolone tablets.   "
143574|NCT01405118|"     This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of     metformin, a probe drug for organic cationic transport.   "
143575|NCT01405105|"     Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative     colitis.   "
143576|NCT01405092|"     Use of on-line blood volume monitoring during continuous renal replacement therapy can     improve volume management in acute kidney injury patients requiring renal replacement   "
143577|NCT01405079|"     Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor     receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC.The EGFR     mutation rate was 30% in Chinese Non-small Cell Lung Cancer(NSCLC). Patients harboring these     mutations in their tumors show excellent response to EGFR tyrosine kinase inhibitors     (EGFR-TKIs). This randomized phase III trial is studying gefitinib to see how well it works     compared to cisplatin-based chemotherapy in treating patients who have undergone surgery for     stage II-IIIA(N1-N2) NSCLC with EGFR activating mutation in Asian population.   "
143578|NCT01405066|"     The purpose of this study is to quantify variation in radiation dose levels across CT     technologists, and determine the effectiveness of combining radiation dose audit reports and     an educational seminar as a means to reduce the variation and level of patient exposure to     radiation.      The investigators expect the radiation dose audit reports and educational seminar will lead     to reduced radiation exposure to patients by making technologists more aware of the risks of     radiation exposure from CT exams and identifying technologists with higher radiation exams     compared with their peers.      The investigators expect the degree to which a technologist is concerned and aware about     radiation exposure and cancer risk will be associated with adherence to radiation reduction     protocols and the subsequent level of radiation their patients are exposed to when receiving     a CT examination.   "
143579|NCT01405053|"     This study is designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of     rufinamide on Lennox-Gastaut Syndrome inadequately controlled in pediatric subjects already     taking other anti-epileptic drugs.   "
143580|NCT01405040|"     The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from     existing indwelling femoral arterial Volume View™ catheter and central venous catheters.   "
143581|NCT01405027|"     The purpose of this study is to evaluate the impact of a physician directed education program     on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated     interferon, ribavirin and boceprevir.   "
143582|NCT01405014|"     The objectives of this research pilot project are to assess the efficacy of the Hold Me Tight     Relationship Enhancement Program with couples where at least one partner has an acquired     brain injury.   "
143583|NCT01405001|"     This represents the first prospective examination of advanced airway management under combat     conditions. The findings will have a tremendous impact on both modern prehospital medical     practice and on the treatment of our wounded Soldiers during the Global War on Terrorism.   "
143584|NCT01404988|"     In the VIP (Veterans Intensive Personalized) Treatment in Heart Failure Study we will assess     2 novel interventions to enhance adherence and improve quality of life in veterans with heart     failure. This 3-arm randomized controlled trial will base one active arm on how ready     patients are for change in terms of diet and medication adherence and will tailor the     intervention based on this. The other active arm will also assess how ready patients are for     change, but will also include tailoring based on availability of environment resources, such     as proximity to health food stores or social support, to further tailor the intervention. The     last active arm is simply an attention group where patients will receive general health     counseling in addition to background care that all patients receive. The overarching     hypothesis is that the tailored interventions will lower heart failure (HF) recurrence and     improve quality of life by better medication and diet adherence compared to attention     placebo.   "
143585|NCT01404975|"     Trans-apical aortic valve replacement is a new treatment for severe aortic stenosis. It is     offered to elderly patients with medical problems that would markedly increase the risk of     conventional cardiac surgery. The rate of delirium (acute confusional state) after surgery in     these patients may exceed 50%. Estimated hospital costs associated with delirium at Toronto     General Hospital last year exceeded $1-million CAD. Pain after surgery and the use of opioids     (morphine type of pain-relief drugs) are known to increase the risk of delirium. The     investigators plan to minimize the use of opioids and improve pain management by replacing     the standard intravenous opioid-based pain management with the paravertebral nerve block     using only the local anesthetic. These two management strategies will be compared with     respect to the rate of delirium, duration of hospital stay, and the overall costs.      Hypothesis: Paravertebral analgesia with LA decreases the incidence of delirium after     trans-apical AVR when compared to standard systemic opioid-based analgesia.   "
143586|NCT01404962|"     This is a multicenter, post marketing surveillance study which aims to evaluate the safety     profile of haemophilus influenza type b vaccine when administered to Korean children     according to the product insert.   "
143587|NCT01404949|"     The purpose of this study is to find what effects, good and/or bad, treatment with two drugs     has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA,     or Vesanoid). It is an approved medicine that causes the leukemia cells in APL to mature. It     is related to vitamin A. The second is arsenic trioxide (Trisenox). It is an approved     medicine for APL that comes back after earlier treatment.      APL is most often treated with tretinoin and standard chemotherapy drugs. These chemotherapy     drugs can cause infection and bleeding. They can also damage the heart and normal bone marrow     cells. This can lead to a second leukemia years later.      In this study, the investigators are using tretinoin and arsenic trioxide together. Both     drugs work to treat APL. They have been used together in only a limited number of people. The     investigators want to use these drugs together to reduce the amount of standard chemotherapy     and decrease side effects. The patient will receive standard chemotherapy with a drug called     idarubicin only if they have a higher chance of the leukemia coming back or a higher risk of     side effects.   "
143588|NCT01404936|"     This is a clinical research study of interferon (IFN) plus chemotherapy with the standard     combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be     given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD     improves the immune response against Hodgkin's disease, and will determine whether the     toxicity of ABVD is increased by adding IFN.   "
143589|NCT01404923|"     The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:        -  Strategy A = MeteoSpasmyl®, on-demand therapy        -  Strategy B = standard of care chosen by the physician   "
143696|NCT01402492|"     The aim of this study is to investigate the safety and effectiveness of buprenorphine in the     presence of naltrexone for the treatment of cocaine dependence.   "
143590|NCT01404910|"     Preeclampsia is a syndrome that occurs in approximately 3% to 8% of pregnancies and is     associated with considerable maternal and neonatal morbidity and mortality. Except for     termination of the pregnancy, effective treatments/preventative measures for preeclampsia are     lacking. Although prolongation of pregnancy benefits the fetus, it is detrimental to the     mother, and is associated with hypertension, proteinuria, and symptoms that suggest kidney,     brain, liver and cardiovascular system involvement.      Placental soluble fms-like tyrosine kinase 1 (sFlt-1) is elevated in women with preeclampsia,     with levels that fall after delivery. sFlt-1 is a variant of the vascular endothelial growth     factor (VEGF) receptor Flt-1, and in the circulation, acts as a potent VEGF and placental     growth factor (PlGF) antagonist. Given that sFlt-1 levels are elevated in preeclampsia, we     are investigating if removal of sFlt-1 from the plasma of women with preeclampsia can improve     maternal and fetal outcomes.      Short-term extracorporeal apheresis with the LIPOSORBER LA-15 System will be the primary     intervention using methods that have been previously applied in pregnant women with familial     hypercholesterolemia.   "
143591|NCT01404897|"     The Dietary Approaches to Stop Hypertension (DASH) trial has been shown to reduce blood     pressure and plasma total and LDL-cholesterol (C) compared to a Western diet, but shows no     benefit on other blood lipid variables associated with cardiovascular disease (CVD) risk,     namely HDL-cholesterol and triglycerides. The overall objective of this study is to determine     whether modification of the DASH diet by substituting carbohydrate with fat will result in     improvements in multiple biomarkers of CVD risk. Specifically, the investigators will test     the hypotheses that modification of the DASH diet by reducing carbohydrate, primarily in the     form of simple sugars and glycemic starches, and allowing for a more liberal intake of total     and saturated fat, primarily from dairy foods, will: (1) improve lipoprotein markers of CVD     risk (reduced total/HDL-C ratio, apolipoprotein B, small LDL particles, and increased HDL-C,     apoAI, and large HDL particles); and (2) result in comparable reductions of systolic and     diastolic blood pressure to those achieved with the standard DASH diet. The investigators     will also assess the effects of the modified DASH diet on markers of insulin resistance and     inflammation. Our main hypotheses will be tested by a controlled dietary intervention     conducted in 40 healthy men and women who will be randomly allocated to consume, for 3 weeks     each, a control Western diet, a standard DASH diet, and a modified low-carbohydrate DASH     diet, separated by 2-week washout periods.   "
143592|NCT01404884|"     This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACR     presbyopic excimer laser treatment algorithm for myopic eyes developed for applying to the     cornea of the human eye in a single center.      The developed software algorithm uses the subjective refraction of the eye to create a     treatment for the distance vision correction. This part of the treatment does not show any     difference to a regular aspheric LASIK treatment for myopic cases.      In addition to the treatment for the distance vision an additional central ablation component     will be added to address the near vision.      The study design is applied as a single center unilateral eye safety and effectiveness study     of the SUPRACOR presbyopic algorithm for myopia with a 3 months postoperative follow up.   "
143593|NCT01404871|"     In this study, the investigators hope to study a number of variables the investigators     believe may help us predict why some people respond better to some medications than others.     Participants will be randomly assigned to receive one of two typical medications for OCD,     clomipramine or escitalopram. Individuals who would like to participate but who have     previously tried one or both of these medications may instead take a newer drug, duloxetine,     and undergo the identical procedures. The factors the investigators will be studying include     demographics (i.e. age, gender, age of onset of OCD), genetic markers (such as variants in     genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes     involved in several brain chemical systems, such as serotonin), the dimensions of OCD     symptoms (i.e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition     will be measured transcranial magnetic stimulation and is being studied because deficits in     this process may be important in the development of OCD. The investigators hypothesize that     certain pretreatment clinical characteristics will correlate with poor treatment response     including earlier age of onset, longer duration of illness, increased YBOCS severity and     presence of significant hoarding symptoms. The investigators expect that increasing degree of     deficit in CI pre-treatment will predict poor treatment response, but that increase in CI     from pre- to post-treatment will correlate with a positive treatment response. Differences in     genetic marker status for cytochrome P450 genes will correlate with tolerability and/or     response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A     will correlate with response.   "
143594|NCT01404858|"     The purpose of this study is to prospectively examine the impact of various lifestyle habits     in both men and women on the outcome of in vitro fertilization. There are 25 infertility     centers in the United States which use the electronic medical record collection entity eIVF,     made by Practice Highway, to collect medical and demographic information on the patients who     are undergoing treatment at these centers. Information on every aspect of each cycle is also     electronically collected daily during each cycle. Demographic and lifestyle information will     be collected on all patients prior to cycle start and lifestyle habit information will be     collected each time a patient logs onto the patient portal, which averages every few days.   "
143603|NCT01404741|"     5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS),     but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment     option but is associated with a high risk treatment-related morbidity and mortality. In the     current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only     treatment according to donor availability in elderly patients with MDS (55-70 years).   "
143604|NCT01404728|"     This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal     stenosis in women receiving pelvic radiation therapy for pelvic malignancies.   "
143697|NCT01402479|"     Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated.     Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt     to test the efficacy of ramipril on the prophylaxis of migraine attacks.   "
143698|NCT01402466|"     The study will test an intervention to help HIV-positive people achieve consistency of HIV     care while transitioning in and out of jail.   "
143595|NCT01404845|"     •Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and     visual impairment in industrialized countries. The macular pigment, composed of carotenoid     derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An     increase in macular pigment following dietary supplementation with lutein and zeaxanthin     could allow early treatment with such supplements in subjects with a high risk of AMD, and     encourage them to change their eating habits.      •Primary outcome:      Comparative analysis of the density and evolution of the density of macular pigment:        -  In patients without any retinal pathology who underwent cataract surgery 1 month          previously        -  In the non-exudative eye of patients with exudative AMD in one eye by analyzing the          density and evolution of the density of macular pigment in the non-exudative eye             -  Secondary outcomes:      Analysis of changes in macular pigment density after taking food supplements (Nutrof Total     versus comparator):        -  Time taken to reach the maximum plateau of macular pigment density (no increase in          density between 2 measurements)        -  Time taken to return to the baseline macular pigment density after cessation of          supplementation             -  Study design :      Pilot study -Prospective, randomised, double-masked, comparative, multicenter.   "
143596|NCT01404832|"     Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to     be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed     PPI failures. Esophageal pH monitoring studies have shown that PPI failure rarely is due to     persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has     been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in     which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause     symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis     underlies PPI failure for patients with GERD symptoms.      Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of PPI     failure in patients thought to have heartburn due to GERD.      Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical     Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to     participate in the study. Patients who provide informed consent will have a medical history     taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI     therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for     one week. The patient will return to the clinic one week later. Patients who feel that their     heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation.     During the endoscopic examination, biopsy specimens will be taken as follows: A. Two     specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from     the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal     esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal     esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion     of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more     extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made     if there is at least one high-power field with >25 eosinophils, or two or more high-power     fields with >15 eosinophils.      Potential Benefits: This study will provide an estimate on the frequency with which     eosinophilic esophagitis is the cause of PPI failure in patients thought to have heartburn     due to GERD. This has substantial potential importance for patient management.   "
143597|NCT01404819|"     The objective of this study is to show that, in patients undergoing carotid endarterectomy,     brain damage, assessed by the determination of S100B before removing the clamp, is less     severe with a balanced anesthesia consisting of remifentanil combined with Xenon     (experimental arm) compared with remifentanil anesthesia associated with propofol (reference     arm).   "
143598|NCT01404806|"     The purpose of this study is to describe drug concentrations of an investigational HIV     medication, GSK1349572, in blood plasma, cervicovaginal fluid, vaginal and cervical tissue in     HIV negative women.   "
143599|NCT01404793|"     Standard anesthetic management of liver transplantation patients includes a general     anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium.     Pharmacokinetic modelling of this agent has been poorly described during liver     transplantation, which impacts on appropriate dosing of this agent within this population     where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during the     various phases of liver transplantation. Plasma drug and drug metabolite concentrations will     be measured using the technique of solid phase micro-extraction (SPME). Measuring and     correlating the levels of rocuronium and other liver metabolites with the degree of post     transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid     diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity   "
143600|NCT01404780|"     Patients undergoing chest surgery often require insertion of a breathing tube (double lumen     tube) after they are unconscious. The double lumen tube enables the anaesthetist to ventilate     (assist breathing) one lung at a time. The other lung is partially deflated to enable enough     space for the surgeon to perform the procedure. The breathing tube is inserted with a     laryngoscope (blade with a light at the end) so the vocal cords can be seen. This is standard     medical practise. Two laryngoscopes are commonly used at Toronto General Hospital to insert     the tube. The Macintosh laryngoscope has been is use for over 50 years and the Glidescope for     over 10 years. Both devices have been extensively researched for single lumen tubes insertion     and found to be very safe and effective. Research is limited to say which of the two     laryngoscope is the most effective for double lumen tubes.   "
143601|NCT01404767|"     This study proposes to assess the effect of the standard of care, which is continuation of     the pre op beta blocker dose into the post operative period compared to the administration of     esmolol titrated to a pre determined target HR. The primary outcome will compare     postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on     metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been     withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes     will compare a) the hemodynamic responses, documenting the incidence of unplanned hypotension     and bradycardia and b) to compare the effects of Heart rate to the incidence of myocardial     ischemia, arrhythmias, delirium and infarction.   "
143602|NCT01404754|"     This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on     mood and psychological experience in people trained to practice MDMA-assistant psychotherapy     in a therapy-like setting. Study participants will prepare for the experience with the     investigators. After preparation, they will have two day-long sessions, one with placebo and     one with MDMA, with the second session happening two days after the first. Order of session     will be assigned randomly and the study will be double-blind. Subjects will complete measures     and talk about the experience on the day after each session. Mood, psychological symptoms,     and interpersonal closeness will be measured before and after each session. The investigators     will speak with subjects again one and two months after the second experimental session, and     subjects will complete a personality questionnaire two months after the second experimental     session.   "
143625|NCT01404455|"     The investigators examined the predictability of stroke volume variation for fluid     responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery     bypass graft   "
143605|NCT01404715|"     This study will address the following question: Does imatinib influence the pharmacokinetics     of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated     that imatinib may block metformin elimination from the kidney by inhibiting organic cation     transporter efflux of metformin. 1. The investigators hypothesize that the addition of     imatinib to metformin therapy will reduce the renal clearance (CLR) of metformin leading to     increased plasma concentrations and risk for toxicities 2. Knowledge of the pharmacokinetic     interaction profile of metformin with organic cation transporter inhibitors, such as     imatinib, is important to help develop safer more effective drug therapy with reduced side     effects.   "
143606|NCT01404702|"     Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual     incidence of 10.5 per million children less than 15 years of age. NB accounts for 15% of     childhood cancer deaths. High risk (HR) patients carry a poor prognosis despite treatment     with intensive chemotherapy, surgery and/or radiation, autologous bone marrow transplant, and     treatment with cis-retinoic acid. New therapies are desperately needed for such patients.     Recently, it has been demonstrated that HR NB patients benefit from anti-GD2 antibody therapy     which directs the immune system against NB cells. To further explore means of harnessing the     immune system to attack NB, the investigators are studying the combination of zoledronic acid     (ZOL) and interleukin-2 (IL-2). ZOL has been demonstrated to have direct anti-neuroblastoma     effects in laboratory studies. ZOL also augments the production of tumor killing white blood     cells called gamma-delta T cells. When used in combination with IL-2, ZOL is capable of     eliciting potent anti-cancer effects in patients, in part, via the expansion of gamma-delta T     cells. In this present trial the investigators aim to study the tolerability of the     combination of ZOL and IL-2 in pediatric NB patients. Patients will also be monitored     radiologically for tumor response to therapy. Correlative biological studies will study the     ability of this drug combination to elicit the production of NB killing gamma-delta T cells     in children.   "
143607|NCT01404689|"     Endoscopic retrograde cholangiopancreatography (ERCP) takes a longer time and is more complex     to perform than the other parallel procedures, causing discomfort to patients. It is commonly     performed under sedation endoscopy. Until recently, the combination administration of     midazolam and opioid has been widely used as standard therapy due to its superior sedation     effect compared to the other sedation agents. Midazolam, however, has problems, such as an     insufficient sedation effect and an intermittent paradoxical response.      Unlike midazolam, propofol has no antagonist and may cause problems such as respiratory     depression, and has a narrow therapeutic range for the sedation effect, consequently     requiring supervision by experienced experts, although it has a better sedation effect than     midazolam. Due to these disadvantages, propofol is clinically less useful than midazolam.      Meanwhile, dexmedetomidine, a selective α2 adrenergic agonist, is known to maintain the     proper level of sedation and has a weak influence on respiratory depression. Recent studies     have shown positive results with dexmedetomidine in relation with the sedation effect for     surgery patients under local anesthesia or in intensive care units.      As such, extensive studies are being conducted on the use of dexmedetomidine in endoscopic     procedures due to the increased attention to dexmedetomidine. This notwithstanding, the     clinical usefulness of dexmedetomidine is still debatable. In particular, studies on the use     of dexmedetomidine for ERCP are very rare.      Given the recent idea that dexmedetomidine may exert a synergistic effect in combination with     midazolam, these authors endeavored to prospectively compare and analyze the sedation effect     and adverse events, including respiratory depression, of the combination therapy of midazolam     and meperidine, both of which have been widely used in patients undergoing ERCP, and of the     combination therapy of midazolam, meperidine, and dexmedetomidine.      The small-scale comparative study on the combination administration of propofol and fentanyl,     which has a high risk of causing complications, and on the single administration of     dexmedetomidine is the only study on the sedation effect of dexmedetomidine in the ERCP     procedure that has yet been conducted; there has been no study that investigated the effect     of the combination administration of dexmedetomidine and other drugs in the ERCP procedure.     This study is thus expected to contribute to the development of guidelines on sedation in the     ERCP procedure.   "
143608|NCT01404676|"     The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic     variability, oxidative stress, and endothelial function in patients with type 2 diabetes.   "
143609|NCT01404663|"     Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can     involve brain and nervous system functions such as movement, learning, hearing, seeing, and     thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these     problems occur as the baby grows in the womb, but they can happen at any time during the     first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem     cells are known as a effective therapy.      In this study the investigators evaluate the side effect of bone marrow stem cell     transplantation in patients with cerebral palsy.   "
143610|NCT01404650|"     This is a multicenter, non-randomized, single agent, Phase II study of AUY922 in patients     with refractory Gastrointestinal Stromal Tumor (GIST). The primary endpoint of this study is     to determine progression-free survival (PFS) for patients with GIST receiving AUY922     intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle with restaging at 6 and     12 weeks and then every 9 weeks thereafter. Patients may continue treatment until evidence of     disease progression.   "
143611|NCT01404637|"     The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal®     D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic     benign prostatic hyperplasia as a first line therapy.   "
143612|NCT01404624|"     The problem point of the Prader-Willi Syndrome (PWS) patient is the obesity which is intense     and the plasma ghrelin level which increases unusual from the recently PWS patients was     discovered. The Ghrelin is endogeneous ligand of growth hormone secretagogue receptor with     peptide hormone and the location is 3p26-p25. Becomes the secretion even from nervous system     but from dignity X/A cell it is secreted mainly and growth is important even in the vagal     control against food and intake and a dignity function even on the action outside which     promotes the secretion which drives it operates. It increases food intake specially and in     order to accomplish the action which diminishes fat utilization the obesity with the week     cause which it does the mortar it is thought. Active the ghrelin of the form is essential in     hormonal activity of the ghrelin and appetite and growth hormone it participates to the     secretion promotion which drives. Action of the Ghrelin measuring the quantitative change in     middle acylated of the PWS patient ghrelin in order to happen after the acylation initially     by one interest ghrelin which is attempted the appetite of the PWS patient is is controlled     the method it will be able to prove the thing directly, it used the RIA kit and the ELISA it     will be able to measure kit it will be able to measure the whole ghrelin to pick the PWS     patient and the blood of the normal army and active ghrelin it measured a change.   "
143613|NCT01404611|"     The purpose of this study is to determine if a combination of an antibiotic plus a     corticosteroid is safe and effective in treating middle ear infections in children with ear     tubes.   "
143773|NCT01402726|"     The purpose of this study is to observe the incident of composite cardiovascular events after     renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and     evaluate safety and efficacy of the intervention.   "
143614|NCT01404598|"     This study will be performed in 2 parts conducted in parallel:      Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen     500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the     pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the     elimination of the drug after its administration) of nitrates (metabolite of naproxcinod)     present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for 7     days or naproxen 500 mg bid for 7 days as a reference.      Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod 3000     mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the     absorption, the distribution, the metabolism and the elimination of the drug after its     administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the     transformation of the naproxcinod, after oral administration of a single supratherapeutic     dose of 3000 mg.   "
143615|NCT01404585|"     The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate is     effective in treating moderate to severe rheumatoid arthritis.   "
143616|NCT01404572|"     The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use     (POU) formulations to the current atazanavir POU in healthy participants and to select 1     atazanavir POU that has the sweetness most similar to the current atazanavir POU.   "
143617|NCT01404559|"     Many service members suffering major limb amputation(s) during active duty seek to return to     active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic     differences exist between popular multi-function prosthetic feet that would facilitate return     to duty for soldiers with amputations.   "
143618|NCT01404546|"     This pilot study examined the effect of providing a 4 weeks of cost free quit smoking     medications to smokers identified in a stroke prevention clinic who were interested in     quitting smoking compared to providing a prescription for the medication only.   "
143619|NCT01404533|"     The overall goal of this research is to develop safe and effective iron interventions that     can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in     the systemic circulation not bound to the iron-transport protein transferrin). The appearance     of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after     oral administration of iron supplements in doses similar to those used in the Pemba trial.     This research project will (i) confirm the appearance of plasma non-transferrin-bound iron     after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body     weight, without food), and then determine the effects on production of plasma     non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of     giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a     lower dose of iron (~0.1 mg Fe/kg) — like that used in home fortification — with the standard     rice meal.   "
143620|NCT01404520|"     The purpose of this study is to test a new preventive and restorative intervention for     patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate     the patients' treatment related symptom burden and to explore the effect of the intervention     on length of hospital stay, duration of sick leave and return to work status. Further, to     examine the relationship of the symptom profile with clinical indicators, physiological     response, physical performance and survival.   "
143621|NCT01404507|"     The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended     by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to     potential increase of bleeding. Compared bolus injection followed by continuous infusion of     Gp IIb-IIIa inhibitor, single bolus administration was proposed to decrease bleeding     complication while maintaining decrease ischemic events. It was also reported that direct     intracoronary injection of abciximab might be superior to intravenous injection regarding     myocardial perfusion.      Aspiration thrombectomy is regarded as important adjunctive therapy in the treatment of acute     ST-elevation myocardial infarction (IIa, level of evidence of B). We hypothesized that     combination of intracoronary abciximab bolus injection and aspiration thrombectomy might     enhance adequate myocardial perfusion in patient with acute ST-elevation myocardial     infarction. We will determine whether combination of intracoronary abciximab injection and     aspiration thrombectomy is superior to each treatment only in terms of myocardial perfusion     through index of microcirculatory resistance and cardiac magnetic resonance imaging.   "
143622|NCT01404494|"     Background:      - Previous studies have shown that computer-based devices that simulate everyday tasks can be     helpful for evaluation and rehabilitation in people who have had strokes. Researchers are     interested in studying whether similar devices can be used to evaluate and treat individuals     who have had a traumatic brain injury, to determine if the device should be developed to help     with rehabilitation in the future.      Objectives:      - To evaluate the effectiveness of a computer-based simulation compared with actual     performance of actions in individuals who have had a traumatic brain injury.      Eligibility:      - Individuals at least 18 years of age who have had a non-penetrating mild or moderate     traumatic head injury within the past year and have experience playing computer games.      Design:        -  Participants will be screened with a physical and neurological examination and medical          history.        -  Participants will complete questionnaires and an interview about mood and feelings,          stress levels, quality of life, and how well they function at work or at home.          Participants will also have tests of memory, attention, thinking, and reasoning. Some of          the questionnaires and tests will be completed in writing, some orally, and some on a          computer.        -  Participants will have movement and coordination tests that involve simple tasks such as          putting pegs in a pegboard, using a key, lifting different objects, and folding things.        -  Participants will duplicate the movement and coordination tests by using a computer          program that simulates the tasks with a cursor on a computer screen. Participants will          do four separate simulated tasks (such as arranging letters or hitting a nail with a          hammer) three times.        -  The full visit will take about 4 hours, and no followup visits are required.   "
143623|NCT01404481|"     The purpose of the study is to compare single use of catheters with reuse of catheters for     intermittant self catheterisation.   "
143624|NCT01404468|"     The optimisation of drug absorption through skin is of great value in modern     therapy.Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug     absorption. However,few studies have compared pulsed and continuous modes of therapeutic     ultrasound.This study compared these two modes by investigating the effect of lidocaine     phonophoresis on sensory blockade.      Ninety-three healthy volunteers, assigned at random to one of three ultrasound     groups:pulsed(ultrasound+lidocaine),continuous(ultrasound+lidocaine)and control(sham     ultrasound+lidocaine).      Lidocaine was administered transdermally using a transducer.Two point discrimination, touch     and maximum pain thresholds were assessed before and after the intervention in each group.      Pulsed ultrasound with topical lidocaine gel induced greater anaesthetic effect compared with     continuous ultrasound with topical lidocaine gel and lidocaine application alone. The     mechanical properties of pulsed ultrasound appear to be responsible for greater drug     penetration.   "
143626|NCT01404442|"     Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an     additive to bupivacaine in patients undergoing cesarean section .      Methods:Following Ethics Committee approval and informed patients consent, Ninety patients     18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal     anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were     randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received     bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group     (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group     (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time     to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level     , onset of motor block, duration of blockade, hemodynamics variables, the incidence of     hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen     (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,     dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were     instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain,     10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient     requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for     post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of     administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.   "
143627|NCT01404429|"     To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in     patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2     weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy)     versus the adverse effects.      Hypothesis: There will be no difference in the adverse effects, but better and faster control     of disease when starting with a higher methotrexate dose   "
143628|NCT01404416|"     The follow-up study was based on our previous nutritional intervention trial entitled Impact     of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744). We followed up     all livebirths born to women of the trial to measure their height, weight, and hemoglobin and     to implement a questionaire survey (including developmental milestones, disease history,     breast feeding, passive smoking, et al). We selected a sub-sample of infants to assess their     IQ, emotional and behavioral problem, and language development status. The outcomes of     interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness,     anemia, developmental milestones, IQ, emotional and behavioral disorder, language     developmental status, and disease history. Other interesting exposure includes breast     feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an     impact on offspring's physical, mental, and language development. We also hypothesize that     cesarean delivery including CDMR has an impact on offspring's these outcomes.   "
143629|NCT01404403|"     This is a safety study of the Rapid System for acute ischemic stroke.   "
143630|NCT01404390|"     This study will be conducted as an open label, single centre, Phase I study of PI3K     (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or     refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8     and Day 15 with three weeks on and one week off in each treatment cycle.   "
143631|NCT01404377|"     Prospective double blind randomized evaluation of the effect of surgical wound infiltration     with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph     node dissection   "
143632|NCT01404364|"     The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and     retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes.   "
143633|NCT01404351|"     The objective of this clinical study is to evaluate the operative performance of the PEAK     PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative     pain, adverse events and skin scarring following surgery; and to compare these outcomes to     the HARMONIC SYNERGY® BLADE.   "
143634|NCT01404338|"     Tachyphylaxis occurs when a medication is applied multiple times and a decreased response     takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly     occur. Other believe that tachyphylaxis can be explain by patient non-compliance with topical     medications. This study is looking to prove or disprove the phenomenon of tachyphylaxis by     using topical steroids in the psoriasis patient population. The investigators are looking to     enroll 10 patients with symmetric, bilateral, and small psoriasis plaques. The investigators     will either apply a strong topical steroid or a vehicle ointment to the plaques, which is be     occluded with a band aid for a one week period. Weekly, the investigators will inspect the     plaques for tachyphylaxis. This regimen will be repeated during phase 2, to see if there is     change in the time to tachyphylaxis. This regimen will be repeated during phase 3, however,     both plaques will be treated with steroid in this phase, and time to tachyphylaxis will be     measured.   "
143635|NCT01404325|"     This trial will evaluate the efficacy of Everolimus in combination with a centre specific     standard immunosuppressive regimen versus a standard immunosuppressive regimen concerning     kidney function in lung transplant recipients.   "
143636|NCT01404312|"     HIV-infected people have an increased risk of developing active tuberculosis (TB). The     standard course of treatment for TB is 6 to 9 months of isoniazid (INH). A shorter course of     treatment may be as effective and potentially increase treatment adherence. This study will     compare the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus     a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active     TB.   "
143637|NCT01404299|"     The purpose of this study is to determine whether protein-energy nutritional supplementation     improves geriatric function in community-dwelling frail older adults of low socioeconomic     status.   "
143638|NCT01404286|"     Purpose: The objective of this study was to evaluate the influence of a session of resistance     training on the sleep patterns of elderly people.      Methods: Forty men aged 65 to 80 years, sedentary and clinically healthy were divided into     two groups: the control group (n=18) and the resistance group (n=22). Both groups underwent     two polysomnography tests, one at baseline and another after either a resistance training     session (One Repetition Maximum - Strength Test, resistance group) or without physical     exercise (control group).   "
143639|NCT01404273|"     This research study is being done to examine how meditation and the relaxation response (RR)     may change brain activity in attention-deficit/hyperactivity disorder (ADHD).   "
143640|NCT01404260|"     Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the     standard first-line therapy for advanced non-small cell lung cancer (NSCLC).      Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical     efficacy, as compared with the best supportive care or standard chemotherapy, when given as     second-line or third-line therapy for advanced NSCLC.      Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with     adenocarcinoma, and patients of Asian origin. In these populations, such treatment is     associated with favorable objective response rates, progression-free survival, and overall     survival. These populations also have a relatively high incidence of somatic mutations in the     region of the EGFR gene that encodes the tyrosine kinase domain.      The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to     carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers     or former light smokers in East Asia . In the subgroup of 261 patients who were positive for     the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than     among those who received carboplatin-paclitaxel(HR= 0.48,P<0.001), whereas in the subgroup of     176 patients who were negative for the mutation, PFS was significantly longer among those who     received carboplatin-paclitaxel(HR=2.85,P<0.001). Gefitinib treatment was well tolerated,     with lower in hematologic toxicity, and no treatment-related interstitial lung disease.In     this study(IPASS), only patients with a mutation of the EGFR gene in the tumor could get     benefit from gefitinib as first line treatment.      Tony S. Mok and his colleague also found that intercalating and maintenance administration of     erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line therapy     led to a significant improvement in PFS .   "
143641|NCT01404247|"     Brief Summary      The purpose of this study is to better characterize the retina and optic nerve in newborns     using spectral domain optical coherence tomography (s-oct). This new technology provides a     very detailed cross-section picture of the cellular layers in the retina and a 3-dimensional     picture of the optic nerve head and the fovea (the center of the retina that provides the     most accurate vision). These images have been used by doctors for more than 5 years to help     diagnose and treat adults with eye diseases, such as macular degeneration, diabetic     retinopathy, retinal detachments, and melanoma. But, it has never been studied in newborns.     In newborns, it would potentially help in the diagnoses of glaucoma, optic nerve hypoplasia,     foveal hypoplasia, and colobomata among many other disorders. Prior to diagnosing disorders,     it is necessary to establish normal values. It is the purpose of this investigation to study     the retina and optic nerves in neonates to establish normal values.      After a parent of a normal newborn provides a written consent, the baby will be taken to the     Eye Clinic where the instrument is located. The baby will be swaddled in one or more blankets     as needed. The infants will be held in front of the instrument by a nurse. The technician     will move the lens of the instrument to about 2 to 4 inches from the baby's eye. The mild     light from the instrument will then enter the eye for a few seconds to obtain the desired     image. The image can be captured through an immobile eye within 5 seconds. If the baby is     fussy, he or she may be given a few drops of a sugar (sucrose) solution on a pacifier for     calming. Although the images can usually be secured through a normal pupil, if the pupil is     found to be too small, two drops of Cyclomydril will be placed on the eye for dilation. This     is the eye drop used everyday in the Eye Clinic and nursery to dilate the pupils of babies.     The dilation will last for about 6 to 10 hours. After the test, the baby will return to the     nursery or be discharged home as intended by the Neonatology Division.      There is minimal risk associated with this investigation. The instrument is non-invasive and     does not touch the eye. The babies will be swaddled and held by a nurse to prevent any     contact with the machine. The eye drop to be used if needed for dilation has been used on     babies at Harbor for about 30 years. It has been found to very safe. The fact that we will     study only term (not premature babies) and will apply only two drops if needed should     minimize any risk from the eye drop.      An ethical issue to consider is that while the study will provide important information that     will undoubtedly help babies in the future, it will probably not benefit the baby being     studied. However, if the baby has an undetected retinal or optic nerve problem, the study may     reveal it.   "
143642|NCT01404234|"     This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis     (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three     28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each     followed by 28 days off AZLI. The total treatment duration was to be 6 months.   "
143643|NCT01404221|"     Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of     the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies     and predict maternal and fetal complications?   "
143644|NCT01404208|"     The purpose of this study is to find out if D-Cycloserine (DCS), taken at the same time as a     child gets cognitive behavioral therapy (CBT) can help children with pediatric     obsessive-compulsive disorder.      Cognitive Behavior Therapy is a talking therapy that will teach children new skills to better     cope with his/her OCD. CBT usually uses exposure-based therapy. This means that the person     with OCD slowly learns to deal with things they usually avoid. This is done by moving from     less stressful situations to more challenging ones.      The investigators hope to enroll about 75 children ages 7-17 years old with OCD in this study     at Massachusetts General Hospital (MGH). The National Institute of Mental Health (NIMH) is     paying for this study to be done.      If your child qualifies for the study, the investigators will assign him or her by chance     (like a coin toss) to either the DCS group or the placebo group. You and the study doctor     cannot choose your child's study group. Your child will have an equal chance (1 in 2) of     being assigned to the DCS group.      Your child will be asked to take one or two capsules of the study drug (either DCS or     placebo, depending which study group they were assigned to) one hour before CBT visits 4-10.     The study coordinator will give your child the study drug at the location of the CBT     sessions. This is to make sure that your child takes the study drug one hour before his/her     scheduled therapy session. We will ask you to record any bad side effect from the study drug     that your child may have before each CBT session.      It will take your child about 34 weeks to complete the study. During this time, the     investigators will ask you and your child to make a minimum of 17 trips to the study center.     There may be up to 23 trips when including CBT Booster sessions.      This study uses a placebo. The placebo looks exactly like the DCS, but it contains no DCS.     The investigators use placebos in research studies to learn if the the results are caused by     the study drug or are due to other reasons. This is a double-blind study. A double-blind     study is a study where both the doctor and the study participant do not know whether the     study participant is being given DCS or placebo.   "
143645|NCT01404195|"     1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the          functional impairment experienced by sarcopenic patients with hip fracture using          nutritional intervention. What makes this study different from prior studies is that it          will be conducted in a hospital setting, unlike most prior studies, which were conducted          in a community setting. The association between muscle mass and strength, inflammatory          indices, and functional impairment versus dependence and fragility will also be          measured.        2. HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in          metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for          treating sarcopenia in elderly patients with hip fracture and improves functional level.        3. OBJECTIVES Primary objective is to assess functional improvement after nutritional          intervention in sarcopenic patients with hip fracture, as measured using Barthel index.           Secondary objectives will include: 1) to show the relationship between metabolic and          inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment          influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased          strength; 5) to assess mortality and morbidity.        4. EXPECTED RESULTS The investigators expect to find that the supplemented group          experiences throughout the study period a significant improvement in functional status          (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased          strength and a reduction in associated complications (falls) are also expected. The          investigators hope to be able to show reductions in inflammatory indices and insulin          resistance.      To conclude, by improving muscle strength and mass the investigators expect to find a     reduction in the disability and dependence of this population group.   "
143646|NCT01404182|"     The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB     trivalent influenza vaccine in adults and elderly people.   "
143647|NCT01404169|"     The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy     compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's     Disease.   "
143660|NCT01404000|"     The purpose of this study s to determine whether treatment with Iodinated Active Charcoal can     improve lung function and physical capacity in patients with chronic obstructive lung     disorders. The rational for the study is the observation that COPD patients have an increased     tissue load of mercury interfering with the function by NeuroEpithelial Endocrine (NEE) cells     in the respiratory tract. Mercury binding to these NEE cells leads to an increased smooth     muscle tonus and a reduced response to bronchodilator treatment. Initial observational data     have shown an improved lung function and improved functional capacity after treatment     motivating a larger placebo controlled POC study   "
143648|NCT01404156|"     The best treatment for resectable esophageal cancer or cancer between esophagus and stomach     (GE junction) is unknown. Although an operation to remove the esophagus is the most common     treatment, previous studies have shown that patients live longer when either chemotherapy or     chemotherapy plus radiation (chemoradiation) is given before surgery (preoperative), compared     to surgery alone. However it is unknown which of these treatments (preoperative chemotherapy     or preoperative chemoradiation) is more effective in improving survival. A study where     patients with resectable esophageal / GE junction cancer are chosen at random to receive one     of the two preoperative treatments would help determine if one form of treatment improves     survival compared to the other.      Patients with localized esophageal / GE junction cancer (adenocarcinoma) will be randomized     to receive either preoperative chemotherapy or preoperative chemoradiation followed by     surgery.      The main objective of this pilot trial is to determine the possibility of conducting a larger     study with many centers participating. If this study proves to be feasible with enough     patients enrolled and able to tolerate treatments without major side effects then we can     hopefully proceed to perform a larger multi-center trial to look for survival outcome     differences between patients who receive preoperative chemotherapy and those who receive     preoperative chemoradiation. The results of this trial would ultimately help us choose the     most effective treatment of resectable esophageal cancer and hopefully improve survival.   "
143649|NCT01404143|"     What is the difference in subscapularis strength between two different methods of     subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a     hand-held dynamometer in the belly-press position at one year post operative? It is the     investigators' hypothesis that a peel of the subscapularis will result in greater strength, a     higher healing rate, and a greater improvement in shoulder function and quality of life     following shoulder replacement.   "
143650|NCT01404130|"     This prospective study tested the effects of isotretinoin in a cohort of patients receiving     standard therapy for acne vulgaris. Subjects completed questionnaires and standardised     computer based cognitive testing using CANTAB to test for cognitive effects particularly on     learning and memory. Test were conducted before starting isotretinoin, after 3 months and     again a month after finishing therapy. This was carried out as a pilot study to        1. Test the hypothesis that oral isotretinoin, over its 4-month treatment time, will result          in a decline in learning and memory as measured using the CANTAB series of test.        2. Generate data for sample size calculation for a larger study to determine the changes in          memory over time in drug and control group        3. Test of CANTAB, questionnaires and data collection forms        4. Select most appropriate outcome measures        5. Identify therapy sensitive cognitive tasks which would be used in future functional          brain imaging studies It was not considered to randomise subjects to placebo.   "
143651|NCT01404117|"     A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled     study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod     (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in     relapsing remitting multiple sclerosis (RRMS) subjects   "
143652|NCT01404104|"     Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by     starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink     the cancer. This study will look at the experimental use of temsirolimus, 12 weeks prior to     the surgical removal of the entire kidney or a portion of the kidney that is involved by the     tumor.   "
143653|NCT01404091|"     The purpose of this trial is to conduct an assessment of brain nociceptin/orphanin FQ peptide     (NOP) receptor occupancy (RO) in healthy subjects.   "
143654|NCT01404078|"     This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy     tolerability of low strength Polycap versus two doses of low strength Polycap in patients     with stable cardiovascular disease in reducing blood pressure and LDL.      To evaluate the tolerability and safety of low dose potassium supplementation compared to     placebo in patients with stable cardiovascular disease.      Approximately 500 patients are planned to be randomized.   "
143655|NCT01404065|"     The purpose of this study is to investigate the effects of Transcranial Direct Current     Stimulation (tDCS) combined with watching a visual illusion on chronic pain due to spinal     cord injury. The investigators hypothesize that active tDCS will reduce pain in subjects with     spinal cord injury when compared to sham stimulation. The investigators will also measure     changes in EEG data (alpha and beta frequencies) as well as motor cortex excitability.   "
143656|NCT01404052|"     The purpose of this study is to see the effects of transcranial direct current stimulation     (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize     that there will be a decrease in pain levels with active stimulation, when compared to sham     stimulation. Before, during and after stimulation, the investigators will measure and assess     changes intracranial blood flow with transcranial ultrasound.   "
143657|NCT01404039|"     The purpose of this study is to investigate the effects of different types of interventions     (motor learning, somatosensory learning, observation task, mental imagery and tDCS) on the     perception of pain and motor cortex excitability in healthy male subjects. This is an     exploratory study of healthy subjects only.   "
143658|NCT01404026|"     The purpose of this study is to investigate the effects of transcranial direct current     stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The     investigators hypothesize that the active tDCS group will show a significant pain/itch     reduction when compared to sham stimulation.   "
143659|NCT01404013|"     This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone     or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).      The investigators hypothesize:        1. Cough score and cough reflex sensitivity will be improved after treatment with          montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.        2. Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have          better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON,          is comparable to symbicort.   "
143674|NCT01403818|"     This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide     calcium hydrate in healthy volunteers.   "
143675|NCT01403805|"     Prospective study comparing the effects of interventions (combined oral care and pneumococcal     plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from     pneumonia.   "
143661|NCT01403987|"     The investigators hypothesize that there is significant variability in management of patients     with ascites despite guidelines provided by the American Association for the Study of Liver     Diseases, the professional organization most involved with management of liver patients. This     variability may be attributable to knowledge deficits, skill limitations, or reflect     systems-issues that limit the ability of a care provider to implement the clinical guidelines     (time constraints, inadequate supervision, availability of appropriate equipment, and     obtaining consent for non-emergent procedures). This variability does a disservice to the     patients being treated, and results in trainee development of habits that are not evidence     based. There are simple teaching tools available that may improve learning and retention of     evidence based practice. Using these tools should result in more consistent appropriate     patient care, improve patient outcomes, and provide better education to our trainees.      The purpose of this study is threefold: 1. To improve medical house-staff's technical     performance of and comfort level with paracentesis; 2. To improve adherence to professional     organization guidelines and to determine if this in fact improves clinical outcomes; 3. To     evaluate efficacy of three teaching interventions in inpatient medicine trainee rotations.   "
143662|NCT01403974|"     This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated     dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI     836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in     cancer growth. BI 836845 will be administered for the very first time into cancer patients.      The study will also look at the overall safety of the drug, and examine the drug levels in     the body at specific timepoints during the trial (pharmacokinetic profile); the effect the     drug may have on tumours will also be examined (pharmacodynamics).   "
143663|NCT01403961|"     The purpose of this study is to evaluate Hemoglobin A1c values previous to a surgery in     patients with diabetes type II and the complication incidence in immediate post surgery.   "
143664|NCT01403948|"     The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability,     pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or     refractory non-Hodgkin lymphoma with at least prior treatments.   "
143665|NCT01403935|"     The purpose of this study is to create an institutional registry of sepsis through a     prospective survey based on epidemiological data, risk factors, diagnosis, prognosis,     treatment, monitoring and survival.   "
143666|NCT01403922|"     This is a two part study. Part 1 will determine determine if administration of TC-5214 has an     effect on sitting blood pressure in patients with chronic hypertension.      Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive     Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).   "
143667|NCT01403909|"     The main objective of this study was to evaluate the effect of intermittent pneumatic venous     compression on intra-operative fluid intake by comparing two groups of patients with or     without intermittent pneumatic compression of the lower limbs.   "
143668|NCT01403896|"     Stem cells can be transplanted from a healthy donor to a patient to combat blood cancers and     other disorders. This process is called stem cell transplantation. Stem cells normally live     in the bone marrow. A bone marrow transplantation (BMT) is when the bone marrow is directly     transplanted into a patient. However, stem cells can also be stimulated to move from the bone     marrow to the blood where they can be collected, a process is called mobilization. When these     stem cells are transplanted it is called peripheral blood stem cell transplantation (PBSCT).     Both stem cell sources are used for different reasons, but PBSCT is much more common.      There is considerable debate as to which stem cell source, BMT or PBSCT, is optimal. There     are differences between the two sources in important transplant outcomes. The stem cell     product that is transplanted, also called the stem cell graft, contains more than just stem     cells. Results from studies suggest that the variation in the cells with grafts may account     for the variation in outcomes. Preliminary data from a recent study conducted by the Canadian     Blood and Bone Marrow Transplant Group has associated relative frequencies of particular cell     populations with leukemic relapse and another important outcome called graft versus host     disease (GVHD). While the later essentially equates to a failed transplant, the former is the     most common and devastating complication of stem cell transplantation.      The only drug used to mobilize stem cells into the blood of health donors for collection is     G-CSF. However there is a new mobilization drug recently approved called plerixafor. This     drug is able to mobilize stem cells when G-CSF has failed and pre-clinical studies suggest     that it may produce a superior stem cell graft to G-CSF alone. There is little information     available, besides safety and efficacy data, about the effects that plerixafor has on the     stem cell graft of normal healthy donors.      This study will compare the stem cell graft in normal healthy donors following plerixafor     mobilization versus plerixafor and G-CSF mobilization. Specifically, they will look at the     cell populations that have been previously correlated with important transplantation outcomes     like relapse and GVHD. The investigators suspect that the stem cell graft mobilized by     plerixafor and G-CSF will provide a superior graft to that mobilized by plerixafor alone.   "
143669|NCT01403883|"     In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of     postoperative anastomotic leakage. The aim of the study was to assess the benefit of an     optimal care, i.e., both psychological and enterostomal therapy care.   "
143670|NCT01403870|"     The purpose of this research study is:        1. to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal          Regions) the electrical signals made by the muscles in the lower back during the          treatment of the low back pain, and        2. to study the changes which take place in these muscles with treatment. The device is          non-invasive which means nothing is put into your body. The CERSR® pad is an adhesive          (sticky) array (ordered rows) of electrodes.      The investigators hope to find information about the quality of the muscles' electrical     signals in reaction to injury causing back pain, which will improve understanding of the     nature of back pain and back injury. The investigators also hope to improve treatment by     creating a simple test, which will tell us objectively (through computerized measurement)     whether the treatment is helping.   "
143671|NCT01403857|"     The specific aims of the Grain Study are to determine if sensitivity to bitter taste affects     the liking and acceptability of different grain products, to determine if exposure to     different types of grain products, over a period of 6 weeks, changes liking and acceptability     and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal     function changes with consumption of whole grains or refined grains.   "
143672|NCT01403844|"     The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy     for assessing vegetable and fruit consumption.   "
143673|NCT01403831|"     The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to     Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a     technologically simple solution using unidirectional daily text messages to consisting of     educational materials, trivia questions and challenges promoting healthy lifestyle choices     and reminders to check blood sugar, take medications and go to clinic appointments. The     investigators believe TExT-MED will improve health outcomes including blood glucose control     and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and     can be quickly adapted to other practice environments.   "
143676|NCT01403792|"     The purpose of this study is to assess the safety and tolerability of intravaginal     administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1     will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to     14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or     placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug     to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical     inspections will be performed to determine what effect, if any, the study drug has had on the     site of administration. Adverse event data will be collected throughout the trial.   "
143677|NCT01403779|"     Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and     normofractionated radiotherapy after breast-conserving surgery. However, the treatment in     these studies was carried out with conventional techniques and not with the modern IMRT. Also     the evaluation of quality of life and cosmetic outcome were not standardized.      This study is a two-arm prospective study comparing normofractionated and hypofractionated     radiotherapy in patients with breast cancer using tangential IMRT techniques.      The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint     is the patients' quality of life.      Patients to be included are breast cancer 60 years old patients or older with tumour stages     pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast     cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15     fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25     fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).      In both groups, a tangential intensity-modulated radiation technique aiming to achieve     optimal dose homogeneity is applied.      Since higher single radiation dose to the heart can lead to higher morbidity and/or     mortality, patient stratification according to the diseased side was adopted where the     left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore     there is no randomization.      For classification and grading of adverse cosmetic events, the Common Toxicity Criteria     (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of     life is to be documented with two standardized, validated questionnaires QLQ C30 and BR23     of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires     are to be filled by the patients themselves at different time points during the study period.      A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of     around 20% is expected after 2 years.      Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power     of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need     for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).   "
143678|NCT01403766|"     Glomerular filtration rate (GFR) is the best known measurement of kidney function. Serum     creatinine (blood test) is the most commonly used marker to predict GFR. It is a convenient,     inexpensive test that involves a single blood draw with rapid results. However, creatinine     has several limitations because its blood level is dependent on age, body mass, and sex. One     of the gold standards for measuring GFR is plasma clearance of an IV injected agent, iohexol.     It has been found to be safe and nontoxic in prior studies, but is not practical in the     clinical setting due to the need for several timed blood draws. Recent studies have     investigated the use of cystatin C as an alternative marker to predict GFR. Cystatin C also     involves only a single blood draw, and has less confounding factors than creatinine since it     is independent of age, body mass, and sex. Currently, it remains controversial whether     cystatin C is a significantly better biomarker of estimated GFR than creatinine. To date,     there has not been a large prospective cohort study to compare cystatin C and creatinine in     pediatric kidney transplant patients who are on maintenance immunosuppression (anti-rejection     drugs). Accurate measurement and early detection of deterioration of GFR is critical in the     care of this patient population. The purpose of this study is to assess the accuracy of     estimating GFR by using cystatin C versus creatinine clearance equations when compared to the     surrogate gold standard of iohexol GFR in pediatric renal transplant patients.   "
143679|NCT01403753|"     The purpose of this study was to measure and quantify children's beliefs about the satiating     properties (i.e. expected satiation)of snack foods. The investigators predicted that children     who were especially familiar with snack foods would expect them to deliver greater satiation.   "
143680|NCT01403740|"     Turkish Acquired Haemophilia Registry is a database in which information about clinical     features and therapeutic management of acquired haemophilia is collected in Turkey.This is a     multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for     acquired haemophilia. Patients will be registered and the response to different therapies,     details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy     (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or     other factors and treated for acquired haemophilia can be entered on the registry. Patients     will be treated according to local practice. No additional tests or procedures are required     by the registry. The retrospective period will not be time-limited and data will be collected     from those recorded in the hospital notes. The prospective period will begin in September     1.2011, and will last for two years.   "
143681|NCT01403727|"     The purpose of the trial is to evaluate the differences between PercuNav assisted and     unassisted biopsy in the areas of CT radiation dose, procedure time and biopsy accuracy.      This prospective, randomized, controlled trial will compare the use of electromagnetic     tracking and image guidance (CT) during biopsy procedures verses the typical CT image guided     procedure alone.   "
143682|NCT01403714|"     This study will address the role of percutaneous renal intervention for a hemodynamically     significant renal artery stenosis in patients with heart failure exacerbations. Current     guidelines suggest evaluation for renal artery stenosis in patients with pulmonary edema or     heart failure that cannot be attributed to poor left ventricular function. While case series     have suggested benefit to percutaneous intervention in patients with heart failure, no     randomized study has addressed the potential benefit of renal stenting for heart failure     patients. Two large randomized trial of renal stenting for hypertension or poor kidney     function failed to show benefit in patients with intermediate renal artery lesions. No     evaluation of the potential hemodynamic significance of the lesions was performed prior to     randomization. The investigators will enroll patients with heart failure exacerbations not     attributable to declining left ventricular function, valvular disease, acute coronary     syndrome, or heart transplant rejection, who on non-invasive imaging appear to have renal     artery stenosis. After routine invasive assessment, including renal angiography and     pressure-wire assessment, patients with hemodynamically significant renal artery stenoses     will be randomized to stent implantation or medical therapy. Patients will then be followed     to determine whether stenting impacts cardiac mortality or hospitalization for heart failure.   "
143691|NCT01403597|"     The study is designed to determine the safety, efficacy, patient comfort and patient     satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved     under 510k clearances. The evaluations will include skin condition, physician/subject     improvement assessment, and subject comfort and satisfaction score by questionnaires.   "
143683|NCT01403701|"     i) The primary objective of this study is to determine if physical therapy improves     postoperative quality of life in participants following vaginal reconstructive surgery for     pelvic organ prolapse and urinary incontinence.      ii) Secondary objectives include:        1. Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse          symptoms) in participants undergoing physical therapy compared to standard postoperative          care        2. Comparing sexual function in participants undergoing physical therapy compared to          standard postoperative care;        3. Comparing postoperative pain scales, and activity assessment in participants undergoing          physical therapy compared to standard postoperative care;        4. Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in          participants undergoing physical therapy compared to standard postoperative care.   "
143684|NCT01403688|"     Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from     infertility treatments may increase breast cancer risk, but there has not been enough     research to know for sure. Researchers want to use a method of taking breast tissue cells     from women who are having infertility treatment. The breast tissue cells might show changes     that would indicate an increased risk of cancer. The method of taking the breast tissue cells     is called Fine Needle Aspiration (FNA).      The purpose of this study is to examine the changes in breast tissue, in women at high risk     of breast cancer who are being treated with controlled ovarian hyperstimulation.   "
143685|NCT01403675|"     Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors     may find that they are not able to produce female hormones, and they may not be able to have     a child. Scientists are trying to find ways to help cancer survivors regain their hormonal     function and possibly get pregnant, if they desire. Scientists have developed a method where     ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into     the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back     into her body is called ovarian autotransplantation.      Ovarian autotransplantation is a very new technique, and there have only been a small number     of women who have had this procedure. So far, only five babies in the world have been born     using this technique.      The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope     to find better ways to use this method to help a woman's ovaries start working again after     chemotherapy. If the ovaries start working again, it might be possible to have a baby.   "
143686|NCT01403662|"     Long-term studies have emphasized that depressive symptoms and episodes account for majority     of the illness burden experienced by individuals with bipolar disorder (BD). Previous studies     have shown that blood levels of proteins called pro-inflammatory cytokines are abnormal in     individuals with bipolar depression. The investigators hypothesize that preventing the     production or release of pro-inflammatory cytokines will result in improvement of depressive     symptoms in individuals with bipolar depression. Minocycline is a medication that inhibits     the activation of immune cells (i.e. microglia) in the brain and reduces the production of     pro-inflammatory cytokines. Treatment with minocycline has been shown to have     antidepressant-like effects in animal studies and improve symptoms of individuals with     schizophrenia. In this study, minocycline (100 mg twice a day) will be administered for 8     weeks to determine if it is an efficacious antidepressant for individuals with bipolar     depression.   "
143687|NCT01403649|"     Beginning with the 2009-2010 season, influenza vaccine is universally recommended for     children age 6 months to 18 years old, placing extra burden on health care providers across     the U.S. The focus of this study is to develop new strategies and implement existing     evidence-based strategies to enhance influenza immunization in these children. The     intervention will involve collaboration from different types of primary care providers, the     Colorado Immunization Information System (CIIS), public health departments and visiting     nursing services (VNA). It will be designed and implemented by those involved with delivery     with a focus on sustainability after the completion of the study. Parental input will be     gathered during the planning year through focus groups to assist in developing the     intervention. Qualitative assessments and examination of processes during the first year of     implementation will guide modifications during the second implementation year in order to     assure sustainability. Primary outcome measures in the intervention and control groups: 1)     increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year     compared to the pre-intervention year among children 6 mo.-18 yr. and 2) increase in the rate     of children 6 mo.-18 yr. who were fully immunized (received all required influenza     injections) during the season. 3) measure outcomes by age group (6 mo.-5 yr., 6-8 yr., 9-12     yr., 13-18 yr.) and types of clinical sites (urban Peds, urban FM, rural FM)   "
143688|NCT01403636|"     Primary Objective:      - To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in     patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle     cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small     lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)      Secondary Objectives:        -  To assess duration of response, progression free survival (PFS), and proportion of          patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or          DLBCL treated with SAR245409        -  To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL          or DLBCL        -  To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with          MCL, FL, CLL/SLL or DLBCL   "
143689|NCT01403623|"     The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared     to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing     hyperthermia (> 37.5 degrees C).   "
143690|NCT01403610|"     The Primary Objectives are:        -  To determine the extent by which TH-302 is able to penetrate the blood brain barrier and          affect tumor tissue        -  To assess the safety of single dose TH-302 in patients with high grade glioma undergoing          surgery        -  To assess the safety of TH-302 in combination with bevacizumab for patients with high          grade glioma        -  To determine the MTD and DLT(s) of TH-302 in combination with bevacizumab      The Secondary Objectives are:      To determine the progression-free survival with or without debulking craniotomy for patients     treated with combination bevacizumab and TH-302 following recurrence on single agent     bevacizumab   "
143692|NCT01402544|"     To determine if patients treated early after diagnosis of wet age-related macular     degeneration can return/maintain to their baseline pre-disease BCVA.   "
143699|NCT01402453|"     Despite unequivocal proof that tight control of blood pressure with antihypertensive     medication can prevent hypertensive complications—including strokes, myocardial infarcts,     heart failure, end-stage renal disease, and death— blood pressure remains uncontrolled in the     majority of individuals with hypertension. We propose a novel patient-centered intervention     that combines monetary incentives and a social psychological intervention to help patients     sustain blood pressure control once incentives are no longer offered by strengthening     intrinsic motivation to control blood pressure among two vulnerable populations: African     Americans, who suffer disproportionately from hypertension, and Mexican Americans, who have     the lowest hypertension control rates of any demographic group in the United States. If the     intervention is successful, it could be adapted as a set of tools to apply in clinical     practice to improve outcomes of a range of chronic diseases, by maximizing the motivation of     patients to optimize their treatment.   "
143700|NCT01402440|"     This study has two phases, a dose escalation phase and a dose expansion phase. For dose     escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in     patients with diffuse large b-cell lymphoma. The endpoint for this objective will be     occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to     characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2     dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this     objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs),     assessment of clinical laboratory values, and vital sign measurements.   "
143701|NCT01402427|"     Background Verapamil is traditionally applied prophylactically in transradial procedures to     prevent radial artery spasm. However, verapamil may have side effects and is contraindicated     in some clinical settings.      Methods: During an investigator‐initiated, randomized, double‐blind trial, we evaluate the     need for preventive verapamil administration. After vascular access is established, patients     receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site     conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks     (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural     and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary     end points.   "
143702|NCT01402414|"     In this controlled crossover study we aim to compare the efficacy of narrow-band UVB (NB-UVB)     with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis.   "
143703|NCT01402401|"     This study will assess the safety and efficacy of AUY922, when administered, in combination     with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received     trastuzumab plus chemotherapy in the first line.   "
143704|NCT01402388|"     The study seeks to establish if weight loss achieved through a program of intensive lifestyle     management can result in improvements in GLP-1 and glycaemic control, in patients with newly     diagnosed type 2 diabetes mellitus.   "
143705|NCT01402375|"     There will be 2 randomized, double-blinded clinical trials to help determine which of     commonly prescribed oral opioid combination is most effective in managing acute extremity     pain after discharge from the adult emergency department. The first trial compares     hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg while the second     trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg.   "
143706|NCT01402362|"     High risk population: Screening for impaired glucose tolerance.   "
143707|NCT01402349|"     Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the     paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence     with significant impact on quality of life and substantial health care costs. In this study     we evaluate the prevalence of CRS in Denmark and there is a need for consensus about     diagnosing this disease. Different questionnaires and different tests used for examination     are evaluated together with the patients compliance and days lost through illness.      Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on     CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires     self reported CRS was evaluated. Respondents were invited for clinical examination including     spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy,     acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of     life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was     diagnosed according to the definition on CRS stated by EPOS (European Position Paper on     Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and     paranasal sinus and should be characterized by two or more symptoms one of which should be     either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure,     +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have     been present > 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year     follow up where examination and questionnaires were repeated and treatment compliance and     days lost through illness were evaluated.   "
143708|NCT01403571|"     Canadian statistics indicate that the incidence of obesity is increasing and that the     occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy     weight, making weight control in this population particularly relevant. Preliminary clinical     data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce     after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite.     Its use may therefore have potential implications in long-term weight management, while     improving diabetes.      The objective of this research (weight loss) is to evaluate whether adding Salba to an energy     reduced diet for six months will result in greater weight loss compared to control in     overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or     obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted     diet and their regular diabetes therapy together with regular exercise. Participants were     randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat     bran control supplement matched for energy. The effect of the supplements on weight-loss     (including waist circumference, % body fat) and glucose control (A1c, fasting glucose levels)     will be assessed. In addition, related outcomes such as low-grade body inflammation,     hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT and     prothrombin time) and satiety scores were evaluated.      Modest weight loss has been associated with improved glucose control in individuals with type     2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight loss     and improve glycemic control and CVD risk factors compared to such a diet alone. Salba may     also promote maintenance of weight loss and therefore help prevent weight gain by providing     feelings of fullness that reduce appetite. In light of the high incidence of obesity in     individuals with diabetes, Salba grain may be a useful addition to the diet.   "
143774|NCT01402713|"     The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of     'GC1107' administered intramuscularly in healthy children   "
143709|NCT01403558|"     The aim of this randomized controlled trial is assess the effect of a psychological based     treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese     patients undergoing bariatric surgery.      Hypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational     interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors     and increase pre-surgical intrinsic motivation for lifestyle changes.   "
143710|NCT01403545|"     Aim of the present study is:        -  To evaluate the safety and tolerability of increasing doses of intravenous liposomal          Curcumin in healthy subjects by means of adverse events, vital signs and safety          laboratory assessments.        -  To investigate the pharmacokinetics of increasing doses of intravenous liposomal          Curcumin in healthy subjects.   "
143711|NCT01403532|"     The traditional therapy for induction of spermatogenesis in male hypogonadotropic     hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy     occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the     investigators raise a new sequential therapeutic approach which can make the treatment more     economic and tolerable. The zinc supplement will be also evaluated in patients in this study.     This randomized, parallel, open, and multi-center study will compare the efficacy of     traditional therapy with new therapy and evaluate the safety of the new protocol.   "
143712|NCT01403519|"     Tau pathology and tangles have been associated with cognitive dysfunction causing     neurodegeneration. AD, the most abundant tauopathy is characterized by amyloid plaques and     tau tangles. An abundance of tau inclusions, in the absence of amyloid deposits, defines     Pick's disease (frontotemporal lobar degeneration), progressive supranuclear palsy (PSP),     corticobasal degeneration (CBD) and other diseases including frontal atrophy associated with     cognitive clinical dysfunction of frontal dysexecutive syndrome, progressive nonfluent     aphasia and semantic dementia as recently reviewed (Gozes 2010). It is the investigators aim     to follow other protein expression [as per recent publications (Marksteiner et al., 2011)] in     blood and CSF samples from those tauopathies.      Significance: Results should establish the possibility of using tau and other proteins as     markers for early detection and disease progression in FTD, also in comparison to Alzheimer's     disease (AD).   "
143713|NCT01403506|"     The purpose of this study is to investigate the effect of (NAC) N-Acetyl Cysteine on     biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated     Lipocalin (NGAL) and Intereleukin 18 (IL18).   "
143714|NCT01403493|"     In this randomized controlled study in patients with irritable bowel syndrome (IBS), the     investigators plan to compare the effects of a multidisciplinary structured patient group     education with a compressed nurse based structured patient group education. The effects of     the interventions on gastrointestinal (GI) and psychological symptom severity, knowledge and     quality of life will be assessed with validated questionnaires at baseline and 3, 6 and 12     months after the intervention.   "
143715|NCT01403480|"     Basal Cell Carcinoma (BCC) is the most common malignant growth in the world. Treatment is     primarily surgical with the goal of excising the growth in its entirety. When pathology     results show that this has not been achieved, a re-excision is routinely performed. This     study examines retrospectively the percentage of re-excisions of BCC that actually proved to     be positive (exhibited growth) among those re-excisions performed at Rambam Healthcare Campus     and Zvulun Community Medical Center during the years 2008-10.   "
143716|NCT01403467|"     This current study aimed to demonstrate the effectiveness of the addition of CPAP to the     current conventional therapy in terms of airway obstruction improvement in acute asthma     patients.   "
143717|NCT01403454|"     This study involves Chronic Kidney Disease patients that must choose the type of dialysis     therapy they ultimately wish to perform. These patients receive education regarding dialysis     types from nurses and Nephrologists at a Kidney Function Program. The investigators have     developed a web-based Interactive Health Communication Application that could provide more     education and support to patients about their dialysis choices. The investigators will     compare patients that will receive usual care dialysis education versus patients that will     receive additional education through this web-based application. The investigators feel that     this tool may increase the proportion of patients who start home dialysis, which offers     advantages such as improvement in quality of life and deceased overall healthcare costs, over     hospital hemodialysis.   "
143718|NCT01403441|"     This study is designed to evaluate the safety and effectiveness of an investigational     procedure for treating people with treatment resistant bipolar depression. Precise dose     delivery of radiation to the predetermined targets in the brain will be accomplished with     known Cyberknife stereotactive radiosurgery methods.. This technology is considered to be     noninvasive (does not physically invade your body). We will be studying if the Cyberknife     influences the sensitivity of certain nerves of your brain. Although many clinical treatments     for psychiatric conditions have been done using stereotactive radiosurgery, the present study     is experimental, because we are seeking to use more moderate doses of radiation that are     intended not to destroy any brain cells, but to normalize or modulate their function.   "
143719|NCT01403428|"     Status Asthmaticus is recognized as a common cause of morbidity in children in the United     States (CDC). In recent years, hospitalization rates have reached an all time high. This     study will evaluate the effect of early use of noninvasive positive pressure ventilation     (NPPV) in children admitted to the pediatric intensive care unit (PICU) with moderate to     moderately severe status asthmaticus to test the hypothesis that early initiation of NPPV     plus standard of care will result in decreased length of PICU stay, significant improvement     in clinical asthma score (CAS) and reduced patient care costs when compared to standard of     care alone.   "
143720|NCT01403415|"     This phase I trial studies the side effects and the best dose of temsirolimus when given     together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and     pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or     non-Hodgkin lymphoma. Temsirolimus may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone,     mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase work in different ways to     stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. Giving temsirolimus with combination chemotherapy may be and effective treatment     for acute lymphoblastic leukemia or non-Hodgkin lymphoma.   "
143721|NCT01403402|"     The Congenital Muscle Disease Patient and Proxy Reported Outcome Study (CMDPROS) is a     longitudinal 10 year study to identify and trend care parameters, adverse events in the     congenital muscle diseases using the Congenital Muscle Disease International Registry (CMDIR)     to acquire necessary data for adverse event calculations (intake survey and medical records     curation). To support this study and become a participant, we ask that you register in the     CMDIR. You can do this by visiting www.cmdir.org. There is no travel required.      The registry includes affected individuals with congenital muscular dystrophy, congenital     myopathy, and congenital myasthenic syndrome and registers through the late onset spectrum     for these disease groups. The CMDIR was created to identify the global congenital muscle     disease population for the purpose of raising awareness, standards of care, clinical trials     and in the future a treatment or cure. Simply put, we will not be successful in finding a     treatment or cure unless we know who the affected individuals are, what the diagnosis is and     how the disease is affecting the individual.      Registering in the CMDIR means that you will enter demographic information and complete an     intake survey. We would then ask that you provide records regarding the diagnosis and     treatment of CMD, including genetic testing, muscle biopsy, pulmonary function testing, sleep     studies, clinic visit notes, and hospital discharge summaries.      Study hypothesis:        1. To use patient and proxy reported survey answers and medical reports to build a          longitudinal care and outcomes database across the congenital muscle diseases.        2. To generate congenital muscle disease subtype specific adverse event rates and correlate          with key care parameters.   "
143722|NCT01403389|"     The purpose of this study is to determine if Eculizumab is safe and effective in the     prevention of delayed graft function following deceased donor kidney transplantation.   "
143723|NCT01403376|"     Primary Objective:      Assess the antibody response to influenza vaccine in patients with relapsing form of multiple     sclerosis (RMS) treated with teriflunomide compared to a reference population.      Secondary Objectives:        -  Assess the effect of teriflunomide on immunoglobulin levels;        -  Assess the safety of influenza vaccination in patients with RMS treated with          teriflunomide.      The reference population was defined as multiple sclerosis (MS) patients with a stable     treatment with interferon-β-1. Antibody response was measured using hemagglutination     inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1,     and B as present in the influenza vaccine used.   "
143724|NCT01403363|"     Fentanyl is considered a potent synthetic opioid widely used in anesthesiology, for short and     long-term pain management, and for sedation. The fentanyl patch is constructed like a matrix,     a system based on a polyacrylate net with fentanyl that attaches directly onto the skin. The     doses available today are from 12µg/h, 25, 50, 75, to 100 µg/h. Despite the variable doses     available, often in certain patients as the elderly or children, there is a need for slower     titration than the 12 µg/h currently available.      In this study, the investigators aim to evaluate pain control and to examine the blood     fentanyl concentration of patients on a fix dose of fentanyl patch up to 100 µg/h every two     or three days, and compare it with pain control and concentration levels obtained from a     similar dose patch, but after cutting the patch into two.      The study will take place at the pain clinic of Clalit Health Services-South District     (CHS-SD), and the Negev home palliative care unit. In CHS-SD there are approximately 300     patients treated regularly with opioids and about 120 patients in the home palliative care     unit. A sample of 95 patients will be recruited. Once consent form is signed, blood samples     will be collected twice: 1. At the time of the visit; 2. After 144 hours (about 6 days) from     the first sample, and at least 36 hours after replacing the cut patch. Pain management will     be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI     questionnaire, and rescue doses used before and after the cutting of the patch. The blood     samples will be transferred to the laboratory for testing of fentanyl concentration levels.   "
143725|NCT01403350|"     Malaria is a common, but decreasing, cause of fever in endemic areas. The use of rapid     diagnostic tests could improve treatment of malaria at the local community level. Deployment     of these tests is, however, a considerable cost. The aim of the study is to evaluate their     effect on improving treatment of fever when used by Community Health Workers in Afghanistan.     In phase I of the study, the hypothesis is that an RDT diagnosis deployed with standard     training and support will improve the accuracy of treatment applied to fever by community     health workers when compared to a diagnosis that is based on symptoms alone. In Phase II of     the study, the hypothesis is that the accuracy of treatment can be improved by additional     training and supportive interventions given to community health workers compared to those who     have only had standard training.   "
143726|NCT01403337|"     Vascular surgery is considered a high-risk operation with an anticipated risk of major     cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication     after surgery carries a long-term higher mortality risk. The main objective of this     investigation is to reduce the proportion of patients having major cardiovascular     complications during surgery through a clinical protocol of remote preconditioning that is     safe, effective and reproducible.   "
143727|NCT01403324|"     Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131     administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to     treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the     pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is     to perform intramuscular injection of recombinant human TSH, a hormone produced     pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the     metastases is similar after rhTSH administration or after thyroid hormone withdrawal.   "
143728|NCT01403311|"     This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in     removing malignant brain tumors during surgery.   "
143729|NCT01403298|"     The purpose of this project is to compare the effect of a family-based HIV prevention program     to the effect of an adolescent-only health promotion program on adolescent HIV risk and     marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island     Family Court.   "
143775|NCT01402700|"     The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming     the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System     for the treatment of stenotic, restenotic or occluded lesions in the common and external     iliac artery.   "
143730|NCT01403285|"     BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a     cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells     without harming normal cells.      IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides     (TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T     cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific     T-cell response against tumor cells leading to decreased likelihood of immune evasion of the     tumor by down-regulation of target antigens.      PURPOSE: The primary objective of this study is to determine the safety and tolerability of     IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor     (GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows     sufficient immunogenicity in these patients.      ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and     have stable disease following at least 4 cycles of adjuvant temozolomide.   "
143731|NCT01403272|"     The primary purpose of this research study is to evaluate if DermaTherapy® bedding will     significantly reduce pressure ulcer incidence by decreasing maceration, friction, and     shearing among residents of Nursing Homes.   "
143732|NCT01403259|"     The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus     oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal     carcinoma.   "
143733|NCT01403246|"     This is a phase I-II multicenter, open label study in previously untreated and elderly     patients (> 60 years) with CLL ,which includes 2 sections:      Induction phase with Chlorambucil and Lenalidomide (CL):        -  Phase 1: a non-comparative phase aimed at defining the MTD of lenalidomide given in          combination with chlorambucil and the efficacy and safety of the lenalidomide and          chlorambucil combination;        -  Phase 2: a non-comparative phase aimed at defining the overall response rate of          lenalidomide given at the MTD in combination with chlorambucil.      Maintenance versus clinical observation:      -A comparative phase including lenalidomide or clinical observation aimed at defining the     benefit of lenalidomide given as maintenance therapy.   "
143734|NCT01403233|"     The purpose of the study is to examine the bioavailability of cogniVida™ in 10 healthy male     subjects after consumption of two different doses of cogniVida™ (50 mg and 100 mg) and to     compare the plasma values with values obtained in subjects receiving rebaudioside A (303.68     mg). In addition, also safety and tolerability parameters 24 hours after ingestion of the     study compounds will be determined.      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by     the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug     Administration does not strictly regulate herbs and dietary supplements. The investigators do     not claim that this supplement is meant to treat any ailment.   "
143735|NCT01403220|"     The primary objective of this study is to compare the efficacity of hemodiafiltration and     hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary     objectives include comparing urea clearance, filter duration, and %down-time, between the two     techniques.   "
143736|NCT01403207|"     This pilot study will use tissues and fluids that are normally discarded during the course of     total knee replacement surgery to investigate potential sex differences in knee     osteoarthritis. Basic clinical demographic information will be obtained as well as     preoperative functional and pain assessment scores, functional tests, and pressure pain     threshold measurement. The purpose of the study will be to investigate if any sex differences     can be identified in these tissues and to investigate if there appears to be any relationship     between these differences and functional scores and tests.   "
143737|NCT01403194|"     The hypothesis for this study is that children with sleep disordered breathing will benefit     from treatment with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway     Pressure (BiPAP) in terms of reduction in cardiovascular risk markers and insulin resistance.      The CPAP machine delivers a predetermined level of pressure. It releases a stream of     compressed air through a hose to the nose mask and keeps the upper airway open under     continuous air pressure. This air pressure prevents obstructive sleep apnea, which occurs as     a result of narrowing of the airway due to the relaxation of upper respiratory tract muscles     during sleep. This machine helps to increase the oxygen flow by keeping the airway open.      The BiPAP machine delivers two levels of pressure. Inspiratory Positive Airway Pressure     (IPAP) is a high amount of pressure, applied when the patient inhales and a low Expiratory     Positive Airway Pressure (EPAP) during exhalation.   "
143738|NCT01403181|"     Analysis of HCV-specific T cell responses in patients treated with boceprevir to assess     whether therapy can induce restoration of the T cell function and to what extent this     recovery can be achieved   "
143739|NCT01403168|"     This is an open, prospective, controlled, randomized, comparative study with 2 arms.      The purpose of the study is to assess the efficacy of osteopathy after breast surgery.      80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will     be followed during one year.   "
143740|NCT01403155|"     DNA vaccines consist of small pieces of DNA also known as plasmids, and have several     potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well     tolerated in humans. The investigators have developed a DNA vaccine, INO-3401, which includes     plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be     delivered via electroporation (EP) which uses the CELLECTRA constant current device to     deliver a small electric charge following injection, since animal studies have shown that     this delivery method increases the immune response to vaccine. The vaccine will be given to     up 30 healthy adult subjects who have participated in study FLU-001. It is hypothesized that     a booster dose with INO-3401 + EP will be well tolerated and immunogenic.   "
143776|NCT01402687|"     The goal of this study is to gain new knowledge about genetic risk factors thta may affect     the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus     following HSCT. The study seeks to understand if different forms of genes result in an     increased risk of sores in the mouth and esophagus.   "
143777|NCT01402674|"     Phentermine, an amphetamine congener, is the most widely used anti-obesity drug in the U.S.     Although phentermine is the agent-of-choice among physicians specializing in obesity     treatment, the use of this drug for obesity treatment by other physicians has long been     curtailed because misapprehensions regarding phentermine safety. Concerns of     phentermine-induced adverse cardiovascular reactions and of phentermine-induced addiction are     two fears that have had a profound negative impact on phentermine prescribing. Although     warnings of high incidence rates of adverse cardiovascular and psychiatric effects are     included in FDA labeling and are often repeated in published reviews, the few clinical     reports in the peer-reviewed medical literature of such adverse effects are anecdotal. Fear     of phentermine adverse effects does not inhibit the use of phentermine by obesity treatment     specialists. A 2008 survey of prescribing practices found that 98% of bariatric medicine     specialists used pharmacotherapy in treating obesity and that 97% of those prescribed     phentermine as their first choice.      The fear that phentermine has addiction potential appears to be a factor influencing     curtailment of use. At the time that phentermine was approved in 1959 the expectations were     that it would prove to be addicting, although perhaps less so than amphetamine. These     expectations were based on the chemical structural similarities between phentermine and     amphetamine and on evidence in rats that phentermine stimulated spontaneous activity. No     evidence suggesting the drug had human addiction potential appeared in clinical trials     conducted prior to approval.      After 52 years of use there is no evidence in the peer-reviewed medical literature to support     the hypothesis that phentermine has significant human addiction potential. Research in     addiction medicine has undergone significant development in the last 50 years. Concepts of     addiction have shifted from an early focus on tolerance and withdrawal to a current emphasis     on the psychological components of dependence. Drug addiction has been redefined as drug     dependence and standardized diagnostic criteria have been adopted for drug abuse, dependence     and withdrawal. Psychometric testing methods have been developed, validated, and applied     clinically for measurements of dependence, drug craving, and withdrawal for a wide variety of     substances of abuse including cocaine, heroin, and amphetamine.      Until recently, none of these addiction medicine metrics had been used to study the addiction     potential of phentermine. Presumably, since phentermine is an amphetamine congener, any     clinical characteristics of dependence or withdrawal should mimic those of amphetamine     dependence or withdrawal. One recent retrospective study investigated symptoms occurring when     patients treated with long-term phentermine in a weight management program abruptly ceased     taking phentermine. The study found that patients on long-term phentermine who ceased     phentermine abruptly by their choice did not have an amphetamine-like withdrawal symptom     complex. Significantly there was no evidence of phentermine cravings. Further investigation     is warranted.      The addiction potential of a drug may be investigated by measuring the drug's propensity to     induce dependence, to induce cravings for the drug, and for cessation of the drug to induce     characteristic withdrawal symptoms. In the case of amphetamine withdrawal symptoms appear     very quickly reaching a maximum at 48 hours after drug cessation.      In this prospective study the addiction potential of phentermine will be assessed with     validated psychometric scales to examine patients who have taken phentermine long-term for     two years or more. Patients who have taken phentermine for 7 to 14 days will also be     assessed. Participating patients who have taken phentermine long-term in this study will be     asked to interrupt phentermine therapy for 48 hours to participate in the study. Scale     examinations will be conducted at 24 and at 48 hours after drug cessation.      Hypotheses        1. Long-term phentermine-treated (LPT) patients do not develop phentermine dependence or          cravings.        2. LPT patients who cease taking phentermine abruptly do not experience amphetamine-like          withdrawal symptoms.      Specific Aims        1. To compare the severity of phentermine dependence and craving between LPT patients and          acute phentermine-treated (APT) patients        2. To compare the severity of stimulant withdrawal symptoms before and after phentermine          cessation in LPT patients.        3. To examine the prevalence of phentermine dependence in LPT patients   "
143865|NCT01401309|"     This study is to examine if there is improved sensitivity in detecting hepatic lesions using     respiratory gating and if there is an improvement in confidence defining lesions as benign or     malignant.   "
143742|NCT01403129|"     Keratoconus (KC) is a corneal disease which will in many cases ultimately require corneal     transplantation to maintain vision. Early detection, which is not possible with current     technology, would allow early treatment and prevent severe damage to KC corneas inadvertently     operated upon for correction of vision. Our aim is to combine measurements of different     properties of the cornea to develop means for early detection of KC.   "
143743|NCT01403116|"     The purpose of this study is to determine the safety and efficacy of an oral testosterone     undecanoate formulation for use as testosterone-replacement therapy in men with low     testosterone.   "
143744|NCT01403103|"     This pilot clinical trial studies cholecalciferol in treating patients with colorectal     cancer. The use of cholecalciferol may slow disease progression in patients with colorectal     cancer.   "
143745|NCT01403090|"     The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central     line catheter. The device is designed to be placed in the inferior vena cava via the femoral     vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous     system. The primary endpoint is freedom from serious adverse events (SAE), defined as death,     symptomatic pulmonary embolism or major bleeding .   "
143746|NCT01403077|"     This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the     treatment of subjects with de novo native superficial femoral artery lesions.   "
143747|NCT01403064|"     The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the     course of oral mucositis in subjects with head and neck cancer receiving concomitant     chemotherapy and radiotherapy   "
143748|NCT01403051|"     This study was done with people who were infected with HIV and needed to start treatment for     their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will     help prevent the bone loss that sometimes happens when people start HIV treatment. For this     study, the following HIV treatment (or HAART) were provided in the form of a single tablet     that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These     drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common     for people who are taking HIV drugs for the first time. The risks seen with this HIV     treatment are the same that you would encounter when taking these drugs outside of the study.     The lists of risks of this HIV treatment are included in this document because the drugs are     provided by the study, not because the drugs are being tested. The purpose of the study is     only to look at the impact of high doses of vitamin D and calcium in preventing bone loss.     There are no study objectives related to HIV treatment (EFV/FTC/TDF).   "
143749|NCT01403038|"     This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects     of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve     and to assess the effect of elagolix on selected endocrine/hormone levels.   "
143750|NCT01403025|"     This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and     type of SADRs (serious adverse drug reactions).   "
143751|NCT01403012|"     Metabolomics of systemic psoriasis treatment   "
143752|NCT01402999|"     This is a Hungarian, Multicentre, Observational Study to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
143753|NCT01402986|"     The purpose of this study is to determine whether the addition of tralokinumab to standard     asthma medication is effective in the treatment of adults with asthma.   "
143754|NCT01402973|"     The purpose of this pilot study is to determine whether it is feasible to conduct a     randomized, controlled dietary intervention trial of high versus low dietary intake of     advanced glycation end products (AGEs) in 24 adults; and to gather preliminary data on the     impact of high versus low AGE diet health parameters. The investigators hypothesize that it     will be feasible to conduct a randomized, parallel arm, controlled dietary intervention in a     pilot study involving 24 subjects.   "
143755|NCT01402960|"     The purpose of this study is to assess the effects of high-definition transcranial direct     current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The     investigators hypothesize that subjects will show a decrease in pain symptoms in the active     anodal stimulation group when compared to sham stimulation.   "
143756|NCT01402947|"     This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR     administered alone & in combination with MMX Mesalazine/mesalamine.   "
143757|NCT01402934|"     The investigators hypothesized that pulse pressure variation (PPV) could predict fluid     responsiveness in spontaneously breathing patients undergoing anesthesia induction.   "
143786|NCT01402557|"     Obesity can cause many health problems, including high blood pressure, diabetes, heart     disease, and stroke. Although some people may lose weight through diet and exercise, many     regain weight over time. There is a need to study new ways of helping people maintain their     weight. The purpose of this research is to study the effect of a weight maintenance program     provided through home television sets connected to the Internet.   "
144294|NCT01395706|"     Objectives of Clinical Trial      The main objective of this clinical trial is to show the efficacy of fluorescence     lymphangiography with indocyanine green (ICG) for the detection of sentinel lymph nodes.   "
143758|NCT01402921|"     Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous     insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on     studies carried prior to CEAP classification (2004). Item C3 of this classification relates     to patients suffering from chronic venous disease and permanent oedema. Literature mentions     only one study in which volume reduction in venous-induced oedema was primary endpoint.     Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2     compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative     measure considered nowadays as being gold standard when objectifying oedema variation. It is     therefore particularly relevant in a C3-patient trial (CEAP classification).      The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT     on volume reduction in permanent CVI-oedema after 3 months of treatment.   "
143759|NCT01402908|"     The purpose of this study is to determine if PI-88 is effective and safe in patients who have     had surgery to remove primary liver cancer.   "
143760|NCT01402895|"     The purpose of this study is to determine if a certain treatment for low back pain can change     the way nerves in the leg send messages. Specifically, the investigators will examine whether     a particular type of physical therapy treatment for individuals with low back pain     (neurodynamic techniques) changes the speed that nerves send/receive signals to/from the leg,     as compared to a different physical therapy treatment.   "
143761|NCT01402882|"     The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on     mortality and disability in patients with traumatic brain injury. The effect of tranexamic     acid on the risk of vascular occlusive events and seizures will also be assessed.     Additionally, a nested study will be conducted in a subset of CRASH-3 trial participants.     This nested study (CRASH-3 Intracranial Bleeding Sub-Study [CRASH-3 IBS]) will examine the     effect of tranexamic acid on intracranial haemorrhage and cerebral ischaemia using CT Scans     in approximately 1,000 patients randomised into the CRASH-3 trial.   "
143762|NCT01402869|"     To establish and compare maximum methemoglobin blood levels and times to maximum     methemoglobin blood levels following the administration of the injectable local anesthetics     prilocaine and lidocaine when used for dental treatment in pediatric patients under general     anesthesia. Patients will be randomized into three equal study groups. Two of the study     groups will receive local anesthetic and the third group will not. Methemoglobin blood levels     will be non-invasively monitored and recorded throughout dental treatment for all groups     using a Masimo Radical-7 Pulse Co-Oximeter device.   "
143763|NCT01402856|"     Teenage driving safety continues to be a major public health issue. Two factors have been     found to contribute to a higher teenage driving accident rate than adults: lack of driving     experience, and risky behaviors. Insufficient driving experience puts teenagers at a     disadvantage in detecting and responding to hazards while driving. Factors contributing to     distracted driving (a diversion in the driver's attention from the road) may include: talking     or text messaging on a cell phone, applying makeup, having multiple passengers, listening to     loud music, eating/drinking, smoking or reading while driving.      This is a prospective study designed to evaluate the effect of an educational program on the     risks associated with distracted driving for teenage drivers. The researchers will compare     cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New     Jersey, where cell phone laws exist, and will educate the beginner driver on the potential     dangers associated with driving without a seat belt, substance use, and participating in     distracting driving behaviors. Knowledge of state laws will also be assessed.      Objectives        1. Educate participants on the potential dangers of distracted driving.        2. Evaluate the impact of the educational program on teenage distracted driving behaviors          by obtaining and analyzing information from student surveys, state law quizzes, and          anonymous observation, pre, post, and delayed post education.        3. Quantify distracted driving behavior in teenage driver's attending local area high          schools by obtaining and analyzing information from student surveys, state law quizzes,          and anonymous observation, pre, post, and delayed post education.        4. Qualify distracted driving behavior in teenage driver's attending local area high          schools by obtaining and analyzing information from student surveys, anonymous          observation, and anonymous voicemails, text messages, and/or emails pre, post, and          delayed post education.      Qualify distracted driving behavior in adults through anonymous observations near local area     high schools.      6. Compare teenage driving behaviors as reported and observed between Pennsylvania and New     Jersey.      7. Compare seat belt usage, driving behaviors, and substance use in the study population to     the state and national averages pre and post education.      8. Compare averages of student's knowledge of state driving laws pre and post education.   "
143764|NCT01402843|"     Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a     representative ARB-series anti-hypertensive drug, have been authorized for use also in South     Korea. They have been tested in many countries and proved to be effective and safe. The     concurrence of dyslipidemia and hypertension has a higher rate, hence statin-series drugs and     antihypertensive drugs are simultaneously administered to such patients. The combined     administration of statin-series drugs and CCB-series drugs have.   "
143765|NCT01402830|"     The purpose of this study is to evaluate the relationship between cancer pain and risk of     depression among cancer patients.   "
143766|NCT01402817|"     This is a pilot study to determine if adults and children with neurofibromatosis type 1 who     have plexiform tumors given Sutent® respond to this drug therapy.   "
143767|NCT01402804|"     Introduction:      Different groups already showed in retrospective subgroup analyses, that there is an     increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment.      Methods:      Light-Transmission aggregometry      Hypothesis:      Simultaneous administration of different NSAIDs and ASA impair the platelet inhibiting effect     of ASA.   "
143768|NCT01402791|"     The primary objective of this study is to evaluate the presence/absence and description of     persistent sexual troubles following surgical treatment for endometriosis for women, and     their partners.   "
143769|NCT01402778|"     Major interest in our investigation is to find out whether distinct fixation techniques     influence catheter dislocation and/ or incidence of local inflammation. A systematic     comparison of two different fixation techniques with regard to catheter location, analgetic     potential and signs of local inflammation will be conducted. To ensure identical patients     groups allocation will be strictly randomized. Furthermore, both patient groups will receive     identical pain medication via the peridural catheter in situ. All catheter tips will be     screened microbiologically after removal.   "
143770|NCT01402765|"     The primary objective of this study is to compare the distribution of pressure among pressure     interfaces between two anti-bedsore mattresses.   "
143771|NCT01402752|"     The primary objective of this study is to evaluate the reproducibility of a method of     measuring blood flow rates to the tracheo-bronchial mucosa using diluted dimethyl ether as a     tracer.   "
143772|NCT01402739|"     Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on     several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants,     and postoperative chest tube output. Allogeneic blood transfusion is associated with     transfusion reactions, infection transmission, and postoperative morbidity and mortality. The     aim of this study is to investigate, whether cardiac surgery patients have a reduced     postoperative chest tube output and transfusion need when using a point-of-care guided     transfusion algorithm compared to standard of care transfusion protocols.   "
143778|NCT01402661|"     The Corrona Data Collection Program study is designed to systematically collect and document     use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs),     biologic agents and any other treatments currently used in the management of Rheumatoid     Arthritis (RA), Undifferentiated Arthritis (UA), Psoriatic Arthritis (PsA), and other     rheumatic diseases. Data collected through the Corrona Data Collection Program will be     maintained in a comprehensive database (the Corrona Database), which will be used for     purposes related to clinical, outcomes, and market research. Participating physicians will     have access to information about their own participating patients, and may use this     information for purposes such as research and in providing patient care. It is anticipated     that the study data may help improve the quality of information upon which clinical decisions     are based.   "
143779|NCT01402648|"     The decreased Estrogen Receptor beta (ERβ) expression in the non adenomatous mucosa of     ApcMin/+ mice favours intestinal neoproliferation. The dietary supplementation with a blend     of ERβ agonists and lignin has been shown to recover ERβ to the healthy wild type levels, and     a reduced polyp number and lower dysplasia was also observed in the adenomatous mucosa. In     this randomised, double blind and placebo controlled study, we assessed if ERβ similarly     guides the apoptotic control of cell proliferation in the non adenomatous colon mucosa of     patients affected from sporadic adenopolyposis, prone to polyp recurrence. For 60 day in     advance of the screening colonoscopy, patients were supplemented with a dietary blend of ERβ     agonists and lignin (Eviendep, CM&D Pharma Limited, London, UK) on top their common diet     (left unchanged during the study period), to study if the pro-proliferative behavior of the     non adenomatous mucosa was effected. Sixty patients naïve from previous and concomitant     hormonal or anti-inflammatory CRC chemoprevention were sequentially 1:1 randomised to active     or placebo supplementation. ERα and ERβ (mRNA, Western Blotting, Elisa, immunostaining),     TUNEL, caspase-3 and Ki-67 (immunostaining) were assessed in bioptic normal colon mucosa     samples. Study power: 80%, type 1 error: .05 (two-tails). Statistics: Non parametric Wilcoxon     test for efficacy. MANOVA for proliferative and apoptotic biomarkers relationships to the     common diet and to the 60 day supplementation.   "
143780|NCT01402635|"     The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten     Emergency Department (ED) length of stay (LOS).   "
143781|NCT01402622|"     To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy     (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in     combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased     intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes     stretch and irritation of the peritoneum, is known to play an important role in postoperative     nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases the risk for     PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit (PACU) stay.     In addition, the patient with PONV is also predisposed to severe complications such as     aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged hospital stay,     and eventually increased medical cost.   "
143782|NCT01402609|"     The transition between acute care and community care represents one of the most vulnerable     periods in health care delivery, particularly as the complexity of inpatient populations     increases. Two recent North American studies found an incidence of post-discharge adverse     events between 19-23%, with adverse drug events accounting for 66-72% of these. The     vulnerability of this period has been attributed mainly to a failure of care providers to     adequately reconcile discrepancies between home medications and discharge medications, as     well as a failure to transfer this and other important information about the hospitalization     and discharge to community care providers. While discharge communication with the primary     care physician has traditionally occurred via a handwritten or dictated summary, major     deficits exist with respect to timeliness of information transfer and adequacy of content in     discharge summaries.      Computer-enabled discharge communications can potentially avert such problems. This is     particularly true for web-based solutions that do not require end users to acquire additional     software/training to use them. The purpose of this research is to definitively assess the     efficacy of a web-based seamless discharge communication tool that the Medical Ward of the     21st Century (W21C - see www.w21c.org) team in Calgary has developed through iterative     consultation with multiple clinical stakeholders as well as patients/families. This tool has     great potential to be implemented on a provincial level as well as across Canada and     internationally because it operates on a web interface that does not confine its     applicability to a single type of hospital information system.      The purpose of this research is to definitively assess the efficacy of the web-based     discharge communication tool that our team has developed in partnership with Alberta Health     Services. In doing so, our specific objective will be to answer the following research     questions:        1. Is the seamless discharge communication tool efficacious with respect to reducing          hospital readmission and mortality (at 3 months), as well as reducing adverse events and          adverse drug events?        2. Does the seamless discharge communication tool transfer appropriate, complete, and          accurate discharge information in a timely manner compared to traditional discharge          communication?        3. Is the seamless discharge communication tool efficacious with respect to improving          physician and patient satisfaction?   "
143783|NCT01402596|"     Thousands of children receive sedation for diagnostic and therapeutic interventions annually,     and this number is expected to increase. Children are at higher risk for sedation-related     complications than adults. In different scenarios, multiple drugs are used to achieve     sedation, each one with particular adverse events that must be monitored and reported.      Children that need CT scans for traumatic brain injuries often need sedation, without needing     and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence     of adverse events; however, despite its worldwide use, it's being abandoned due to bitter     taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the     other hand, produces high and fast concentrations on CSF with greater rates of success but     probably with higher adverse events. There are no prospective studies with large series of     patients using intranasal midazolam.      The aim of this study is to determine if nasal midazolam is a safer approach and more     effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT     scans.   "
143784|NCT01402583|"     Menopause represents a critical period in a woman's life as the hormonal changes and the     failing ovarian function not only determine relevant modifications in the reproductive     function but also in many other conditions and organs that apparently are scarcely linked     with hormones. The PI's centre has among its main goals the treatment of chronic liver     disease; in the last years, a increasing interest in gender-related issues has grown.      Goal of this study is to verify the impact of menopause on response to antiviral therapy for     CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve     this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the     University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic,     clinical and biochemical data as well data regarding the reproductive history, time, type,     length of estrogen deprivation and of hormone-replacement therapy will be collected.   "
143785|NCT01402570|"     In this study, people who have symptoms of post polio will take oral glutathione supplements     for three months. Their levels of fatigue, physical activity and sleep efficiency will be     assessed.   "
143787|NCT01402336|"     GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been     accomplished by several randomized controlled trials compared with conventional GnRH agonist     long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating     issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is     to investigate the laboratory and clinical priority during ovarian stimulation for IVF in     patients with PCOS treated with three different protocols.   "
144523|NCT01392729|"     This prospective observational study will evaluate the efficacy and safety of Avastin     (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated     metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.   "
143788|NCT01402323|"     Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic     space closure after extraction of a tooth. They occur in about 35% of the cases. Increased     risk of developing a gingival cleft is given in the mandibular arch. A gingival invagination     impairs aesthetics, orthodontic treatment and periodontal health. The aim of this prospective     split-mouth designed observer blinded study is to evaluate possible differences between tooth     movement in recent or in healed extraction sockets on incidence of gingival clefts. We     hypothesize, that similar to the results originated from an animal study immediate movement     in extraction sockets reduces incidence of gingival clefts during orthodontic space closure.   "
143789|NCT01402310|"     The purpose of this study is to compare Bishop score, sonographic cervical length and     multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to     spontaneous labor and mode of delivery.   "
143790|NCT01402297|"     The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen     species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of     nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after     30, 60 and 120 minutes.   "
143791|NCT01402284|"     Background:      - Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating     multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune     system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is     sometimes used to treat (alone or with other drugs) certain types of cancer, especially     multiple myeloma. This combination of drugs has not been tested in people with multiple     myeloma. Researchers want to see whether it is safe and effective for this group.      Objectives:      - To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in     treating multiple myeloma.      Eligibility:      - People at least 18 years of age who have multiple myeloma that has not been treated.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood and urine tests, a bone marrow sample, and molecular imaging studies.        -  Participants will have eight 28-day cycles of treatment. The combined study drugs will          be given as tablets and injections. Those in the study will be monitored with frequent          blood tests, bone marrow samples, and molecular imaging studies. In addition to current          standard measures to determine clinical responses, molecular tests will be conducted to          define evidence of minimal residual disease.        -  After the first four cycles of therapy, those who are eligible for a stem cell          transplant will have stem cells collected and stored for use if the cancer returns.        -  After stem cell collection, participants will have the second four treatment cycles.           -, If the disease has improved or is stable at the end of eight cycles, those in the          study may have another 12 cycles of low-dose (maintenance) lenalidomide alone.        -  Participants will have regular follow-up visits after the end of the study chemotherapy.   "
143792|NCT01402271|"     RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth     of tumor cells, either by killing the cells or by stopping them from dividing.      PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of     pazopanib hydrochloride when given together with paclitaxel and carboplatin in treating     patients with refractory or resistant ovarian epithelial cancer, fallopian tube cancer, or     peritoneal cancer.   "
143793|NCT01402258|"     The purpose of this study is to determine whether tailored internet-administrated CBT is a     feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive     symptoms in a clinical setting.   "
143794|NCT01402245|"     Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia.     The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc     polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)   "
143795|NCT01402232|"     To raise optimal strategies for reduction of risk of contrast-induced nephropathy according     to several combinations of different risk factors and clinical practice and determine and     supply the guidance for clinical practice   "
143796|NCT01402219|"     The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN)     following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque     320) in patients with chronic kidney disease undergoing coronary angiography.   "
143797|NCT01402206|"     Most people in Sweden with mild to moderate depression are treated in primary care, but     follow-up is unstructured, and we know little about whether structured, follow-up would     affect the prognosis for depression and working life. The purpose of this study is to     determine the effectiveness of regular, structured, patient-centered visits on mild to     moderate depression.   "
143798|NCT01402193|"     The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential     Arimidex in postmenopausal women with breast cancer, as measured by the proportion of     patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy     relative to the pre-treatment baseline.   "
143799|NCT01402180|"     A randomized phase II tials to study whether it's benefit of adding Nimotuzumab to     chemoradiation for patients with esophageal squamous cell carcinoma after radical     esophagectomy who suffer with locoregional lymph nodes recurrence.   "
143800|NCT01402167|"     The primary objective of this study is to compare the volume of injected ciment (polymethyl     methacrylate) between a group of patients treated with vertebroplasty and a group of patients     treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral     height, volume and cyphotic angle between the two techniques, as well as extravation of     ciment and functional and quality of life aspects related to these techniques.   "
143801|NCT01402154|"     The primary objective of this study is to evaluate the predictive value (in terms of     remission) of a new technique for detecting circulating, functional, prostate cells among     patients with localized adenocarcinoma of the prostate, and prior to any treatment.   "
143802|NCT01402141|"     The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction     in a double-blind, randomized, placebo-controlled, human trial   "
143803|NCT01402128|"     Barley, like oats, is a rich source of the soluble fibre β-glucan, which has been shown to     significantly lower LDL-cholesterol (LDL-C). However, barley foods have been less widely     studied.   "
143826|NCT01401829|"     To determine if weekly exercise compared to stretching has an effect on fatigue, depression,     and anxiety in endometrial cancer survivors.   "
143949|NCT01400217|"     This study will compare the absolute and relative effectiveness of asthma management in     patients on inhaled corticosteroid (ICS) maintenance therapy as either extra-fine-particle or     larger-particle formulation beclomethasone dipropionate (BDP) via metered-dose inhalers     (MDIs) using the propellant hydrofluoroalkane propellant (HFA-BDP), namely Qvar® MDI compared     with Clenil® MDI.   "
143804|NCT01402115|"     Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They     are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as     various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can     prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified     β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing     effects. However, no investigation has been conducted on the effect of polycan on bone health     in perimenopausal women.      Therefore, in this study, we investigated the effect of polycan on biochemical markers of     bone metabolism in Korean perimenopausal women.   "
143805|NCT01402102|"     We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects     who were given aged garlic powder over a period of 12 weeks. We measured serum lipids,     including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL)     cholesterol, and triglycerides, and monitored their blood pressure.   "
143806|NCT01402089|"     It is well known that substantial interindividual variability of CYP3A4/1A2-phenotype     activity is an important contributor to individual differences in the sensitivity to the     frequently used tyrosine kinase inhibitors sunitinib and erlotinib. This study tests the     potential for CYP-phenotyping to predict individual pharmacology and derive dosing algorithms     for more tailored treatment of these drugs.   "
143807|NCT01402076|"     The purpose of this research study is to understand whether there is any difference in the     amount of midazolam (including its breakdown product) in the blood when midazolam is given     with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the     blood when rosiglitazone is given with tasimelteon.   "
143808|NCT01402063|"     To obtain preliminary data in a randomized phase II study whether PPX/RT improves     progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT     methylation.   "
143809|NCT01402050|"     OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled     release prostaglandin (Cervidil™) for cervical ripening in term and near term women     presenting for labor induction.      HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley     catheter will decrease the mean time from induction to delivery by six hours compared to     controlled release prostaglandin (Cervidil™).   "
143810|NCT01402037|"     Increased glycemic variability has been proposed as an independent predictor of hypoglycemia     in diabetic patients. Likewise, episodes of dysglycemia have been found to be predictive of     diabetes in antibodypositive nondiabetic individuals. We hypothesise that an in-depth     observational study comparing state-of-the-art measures of functional beta cell mass and     glycemic variability will specify the relationship between both variables over a broad range     of residual function and will identify treatment goals for functional beta cell mass to be     reached in future beta cell therapy trials in order to avoid frequent hypoglycemia in     patients and dysglycemia in risk groups. The available expertise and infrastructure (see     background and (inter)national context) place the promoters of the present project in a     unique position to carry out the planned experiments and support their feasibility.   "
143811|NCT01402024|"     Chemotherapy induced nausea and vomiting (CINV) is one of the few mostly observed distressing     toxicity of cancer treatment. It can occur up to 90% in case of highly emetogenic     chemotherapy use. CINV causes disturbance in daily living of cancer patient and reduces     compliance with treatment Even with the standard anti-emetic measures up to 50% patient can     suffer from this complication. Whereas there is standard anti-emetic guideline exists in case     of adult patients, there no such guidelines made in pediatric population. The new drug     Aprepitant has been recommended for use in adults with high efficacy, there no such concrete     data available in children regarding its use. There are few retrospective reports and limited     data available regarding use of Aprepitant in children with satisfactory efficacy in reducing     CINV. As there no randomized large data to suggests its efficacy and its routine use in     children, we have planned this study.   "
143812|NCT01402011|"     HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments     and tendons of the shoulder is an effective treatment that decreases pain, increases     functional capacity and promotes healing better and in less time than standard treatment with     physiotherapy.      OVERVIEW: 75 subjects with rotator cuff tendinopathy proven by ultrasound will be recruited     and assigned randomly into one of three groups of 25 to receive one of these three different     treatments:      Group A (test): 25% dextrose with 0.1% lidocaine, injected into the tendons and ligaments     Group B (control): 0.1% lidocaine injected in the rotator cuff tendons and ligaments Group     C(control): 0.1% lidocaine injected subcutaneously above these structures All subjects will     receive physiotherapy every other week for three months. To avoid placebo effects, patients,     the radiologist and physiotherapist will not know to which treatment group the patients     belong; the physician administering the injections will not be involved in assessing     disability before or after treatment. (Note: The physician will know which patients belong to     group C because it will be obvious: they are delivering a subcutaneous - versus a joint -     injection).      There will be three sets of injections - one set per month for 3 months. The patients'     condition will be tracked for nine months after the first treatment, to monitor changes in 3     outcome measures: pain (VAS and Rx #s), function (DASH and PESS), and tendon healing (as     assessed by ultrasound).   "
143835|NCT01401712|"     Rib fractures are a common injury of trauma patients and can cause significant pain which, if     inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure.     Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are     used to treat the pain, but placement can be risky as rib fractures are often associated with     other injuries and complications.      An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved     device that automatically and continuously delivers medication to the region of the thoracic     intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system     effectively reduced pain and increased lung volumes after one hour, in patients with three or     more rib fractures. However, that study sample was small and did not have a comparison group.     In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We     hypothesize that trauma patients with three or more rib fractures, who receive pain     management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus     have a shorter hospital length of stay (LOS) when compared with epidural analgesia.   "
143813|NCT01401998|"     In 2005, The University of Alabama at Birmingham established a NIDDK-funded,     interdisciplinary center of excellence in PKD-related research, with specific emphasis on     recessive PKD. In the previous Core Center award period, we developed a Core Resource to     capture clinical and mutational data for ARPKD patients (Core A: ARPKD Clinical and Genetic     Resource, NCT00575705). However, studies in the last several years have demonstrated that     ARPKD and other single gene disorders characterized by renal cystic disease and extra-renal     phenotypes share numerous pathogenic features. In the current competitively- renewed Center,     we have expanded this Core resource to include other hepato/renal fibrocystic diseases.      Goals for the Core A: The Hepato/Renal Fibrocystic Diseases Translational Resource are:        1. - Clinical Database:           • Expand our comprehensive Clinical Database to include information from all patients          who meet the inclusion criteria for hepato/renal fibrocystic diseases.        2. - Mutational Database:             -  Test children with ARPKD and other hepato/renal fibrocystic disease to identify               genetic mutations, establish a DNA bank for patients with hepato/renal fibrocystic               diseases and develop a Mutational Database. This Database will be capable of               linking clinical and mutational information via a unique identifier in a searchable               format to facilitate genetic research (e.g. genotype-phenotype correlations, new               disease gene studies, and modifier gene studies), translational studies, and               clinical trials.                3- Tissue Resource:             -  Much of the research that is performed on diseases of the kidney, including               recessive genetic diseases, requires human tissue from both affected as well as               non-affected (controls) individuals. In this Core Resource, we are establishing an               independent tissue resource which would supply investigators throughout North               America with samples of hepato/renal fibrocystic disease affected tissues for               studies of these disorders.                4- Educational Resource:             -  Expand our multi-media, web-based resource to provide a reliable up-to-date, and               comprehensive informational resource for ARPKD and Hepato/Renal Diseases families,               their physicians, and genetic counselors.      All the information regarding participation in Core A: The Hepato/Renal Fibrocystic Diseases     Translational Resource is available at: http://www.arpkdstudies.uab.edu/.   "
143814|NCT01401985|"     A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects     with Opioid-Induced Constipation   "
143815|NCT01401972|"     In this observational study the investigators will undertake imaging studies on men with     prostate cancer. The primary hypothesis is that ultrasound spectroscopy could be used to     determine the extent of disease inside and outside of the prostate gland in patients with     prostate cancer. It is hoped that the changes in ultrasound backscatter parameters obtained     before radical prostatectomy could be used to correlate with pathological findings from the     prostate specimen after surgery.   "
143816|NCT01401959|"     The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients     who do not achieve pCR following standard neoadjuvant chemotherapy. Three cohorts of patients     will be evaluated separately based on tumor type: triple-negative,     hormone-receptor-positive/HER2-negative, and HER2-positive.   "
143817|NCT01401946|"     The study was done to elucidate relationships between midlife women's self-reported hot     flashes, neuropsychological symptoms, cognitive performance or sleep.   "
143818|NCT01401933|"     This is a phase 1, open-label study designed to determine the interaction of rifampin with     linifanib.   "
143819|NCT01401920|"     The trendelenburg position is usually applied to increase the cross-sectional area of the     IJV. However, trendelenburg position requires a tilt table to place the head in the down     position. Trendelenburg position could also increase intracranial pressure. Passive leg     elevation redistributes more blood from the lower extremity into the central veins and is     proved to increase the cross-sectional area of IJV in adults. However, the effect of leg     elevation on the cross-sectional area of IJV in small infants and children has not been     evaluated.      The investigators evaluated the effect of passive leg elevation on the cross-sectional area     of IJV in subjects undergoing open heart surgery for congenital anomaly.   "
143820|NCT01401907|"     The purpose of this study is to compare two types of care - standard oncology care and     standard oncology care with early palliative care (started soon after diagnosis) to see which     is better for improving the experience of patients and families with advanced lung and     non-colorectal GI cancer. The study will use questionnaires to measure patients' and     caregivers' quality of life, mood, coping and understanding of their illness.   "
143821|NCT01401894|"     The purpose of this research study is to assess what the participant understands about their     illness, prognosis, the goals of the cancer treatment and their communication with their     oncology providers. This study will help us to figure out how the investigators can improve     how other patients understand their illness and goals of treatment and help us improve     communication with their doctors. This research is being done because there is not a lot of     information on how much patients understand about their illness and prognosis.   "
143822|NCT01401881|"     This study will assess relationship between ischemic time and the extent of myocardial     infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation     myocardial infarction) and primary percutaneous coronary intervention.   "
143823|NCT01401868|"     The purpose of this study is to determine the tolerability of ME-143, find the maximum     tolerated dose, and the safety profile in patients with refractory solid tumors.   "
143824|NCT01401855|"     This study will investigate the usefulness of an optical probe in the differentiation of     thyroid cancer from normal thyroid tissue in a thyroidectomy specimen. This is the next step     in the research that this team has conducted through our prior Institutional Review Board     (IRB)H-28135, in which the investigators successfully demonstrated that use of the optical     probe readings on thyroid specimens ex vivo could successfully discriminate benign from     malignant disease. The Elastic Scattering Spectroscopy (ESS) probe has also been IRB approved     and a clinical trial conducted in vivo at Boston University/Boston Medical Center by Dr.     Satish Singh and Dr. Irving Bigio. The investigators intend to now bring this project to the     clinical setting of thyroid disease. The optical real-time readings will be compared to the     histological analysis from the same area. Subjects already undergoing thyroid biopsy for     thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules     will be eligible to participate. During the already scheduled thyroid procedure using a fine     needle aspiration biopsy needle, optical readings will be taken from the thyroid gland and     these same areas will then be analyzed in the usual standard fashion. The reading will then     be correlated with the histological results. In addition, if lymph nodes are biopsied as part     of the evaluation they will also be tested prior to histological standard processing. All     specimens and data will be de-identified once data collection and analysis is complete. Our     goal is to use optical real-time readings to improve the differential diagnosis of benign     from malignant thyroid nodules and avoid surgery for the purpose of diagnosis alone.   "
143825|NCT01401842|"     The investigators will conduct a controlled clinical trial with U.S. Army soldiers training     to become combat medics. The purpose of this study is to determine if a 11-week, high     intensity exercise program targeting the low back muscles using specialized equipment will     result in a 25% increase in low back muscular strength and endurance compared with a lower     intensity general core stability exercise.   "
143827|NCT01401816|"     Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are     unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the     birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%).     It has been estimated that if Emergency Contraception (Plan B) was used after every     contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions     annually.      Previous studies have showed the effectiveness of emergency contraception decreases with time     after intercourse; the sooner it is taken—even if it means a matter of hours—the more     effective it is in preventing pregnancy. Based on previous studies, it is clear that relying     on obtaining emergency contraception on the same day or even the day after unprotected     intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the     adolescent mystery caller did not have the medication available the day of the call and     almost all of the pharmacies not stocking the medication would take greater than 24 hours to     obtain it through their ordering system.      Thus, the concept of advanced provision of emergency contraception has been proposed to     assure that the medication can be taken as soon as possible. Although this practice is known     to be safe and has not shown any association with increased sexual risk or behaviors, it is     unclear how often/if adolescents will fill a prescription for a medication that is not needed     at the time of a medical encounter.      The investigators propose a randomized pilot study (n=60) of a text-messaging intervention     that aims to increase the rate at which prescriptions for emergency contraception are filled.     Based on practice norms in the BMC Adolescent Center, sexually active female adolescents     (ages 13-21) in both the control and intervention groups will be provided a prescription for     emergency contraception. The intervention group, however, will receive follow-up text message     on their phone reminding them to fill the prescription.      Boston Medical Center Health Plan will provide prescription fill data regarding the     prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all     study participants will be contacted for a follow-up survey.   "
143828|NCT01401803|"     The purpose of this study is to provide data to assess Dysport™ injections as a treatment     therapy for brow ptosis. This study will assess the outcome of brow lifting with use of     Dysport.   "
143829|NCT01401790|"     In a Pediatric University Teaching Hospital in Montreal, an Intelligent Distance Patient     Monitoring Program was developed to allow for:        -  Automatic download of blood glucose levels        -  Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical          team        -  Changes in treatment plan by the diabetes professionals        -  E mail exchanges between families and health care professionals        -  Reinforcement of teaching program      Use of this program does not replace the existing diabetes education program nor does it     preclude contacts with the diabetes team. This service was devised to complement the care     already in place for families of children and adolescents with diabetes, hence the term     ''telehomecare-enhanced'' approach.      Hypotheses        -  This approach would not incur more health problems for Web e Phone users when compared          to patients treated by the ''conventional'' approach (telephone and FAX).        -  Use of the Web e Phone would save time for members of the diabetes health providers and          consequently cut costs.        -  This means of communication would be acceptable and user friendly for both families and          health care professionals.      OBJECTIVE - To determine the effects of a telehomecare (THC) program used for 3 months in     families of children and adolescents with newly diagnosed type 1 diabetes.      RESEARCH DESIGN AND METHODS - A bilingual telehomecare program was developed for type 1     diabetes at the Centre Hospitalier Universitaire Sainte-Justine in Montreal. Between February     2008 and August 2009, newly diagnosed patients and their family were randomly assigned to the     standard education program or to the telehomecare-enhanced group. Outcomes of interest were     patients' and parents' health (reported number for total and nocturnal hypoglycemias; quality     of life using the Diabetes Quality of life for Youth questionnaire and a validated Life     Habits survey); knowledge of diabetes (using pre and post intervention questionnaires);     organizational impacts (number and time for contacts with the nurses or with the physician on     call) and family satisfaction with the software application.   "
143830|NCT01401777|"     The objective of this study is to assess and quantify any differences between assisted (using     real-time visualization of tracked cryo-probes) and unassisted cryoablation procedures using     pre-procedure CT scans or CT fluoroscopy with respect to:      Primary Endpoint:      • TRE Target Registration Error (distance between virtual needle position (tracking data)     and the actual needle position (CT confirmation scan))      Secondary Endpoints        -  Accuracy of needle targeting - The vector of each needle insertion (The initial vector          allows us to project the path to the pre-defined target. If the initial entry point is          not ideal, the path to the target will need adjustment) Based on a two-sample t-test          (significance level of 0.05, two-tailed), the study has 89% power to detect a difference          of 2mm in accuracy between the two treatment groups (assuming a standard deviation of          1.9mm).        -  Measure time difference between assisted and unassisted procedure   "
143831|NCT01401764|"     The purpose of the study is to compare local pain experienced after subcutaneous injection of     three excipient buffers for delivering protein drugs.   "
143832|NCT01401751|"     The purpose of this study is to evaluate the performance of an insulin pump controlling     algorithm while the subject is under close medical supervision in the Clinical Research     Center (CRC) setting.   "
143833|NCT01401738|"     This study is a retrospective review of chart. Clinical results including range of motion,     muscle power and scores will be recorded. Arthroscopic surgery of rotator cuff, labrum and     capsule well be re-evaluated for clinical application.   "
143834|NCT01401725|"     Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels     of the legs or lungs. They can block normal blood flow, damage organs, and even cause death.     The risk of VTE is increased in people who are sick or immobile. VTE is the most common     preventable cause of death in hospitalized patients, and its VTE prevention should be a top     patient safety priority. Though there is good evidence that injectable blood thinners and/or     compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton,     Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the     process of introducing electronic order sets - computer programs that help doctors order     medications and other healthcare interventions for their patients. The investigators would     like to study if these electronic order sets can help improve the rate of appropriate VTE     prevention in hospitalized medical patients. The investigators will examine the rate before     and after the introduction of electronic order sets at the Juravinski Hospital and the     Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an     additional computer program, called a computerized decision support system (CDSS), that helps     them decide on the best strategy to prevent VTE in individual patients. The rates of VTE     prevention at each hospital will be compared to each other, and to the rates at St. Joseph's     Healthcare Hamilton, which will receive neither the order sets nor the CDSS.   "
143836|NCT01401699|"     The specific aim of this study is to determine the accuracy of Optical Coherence Tomography     (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a     clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using     the developed OCT imaging probe will be determined and compared with those obtained through     the traditional standard of care endoscopic biopsy .   "
143837|NCT01401673|"     The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic     cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation     is a hyper-excitability of the sensory nerves as they join the central nervous system, and is     believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor[1-3].   "
143838|NCT01401660|"     The purpose of this research study is to measure with CERSR® (Computerized     Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the     muscles in the lower back 1) when the subject has no low back pain 2) during the time low     back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to     study the changes which take place in these muscles as the pain improves with physical     therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan     parameters for normal (pain-free) subjects are different from those of subjects with low back     pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment     which leads to relief of low back pain following no more than eight weeks of physical     therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as     measured using the Oswestry Disability Index.   "
143839|NCT01401647|"     The primary objective of the trial is to determine if survival to hospital discharge is     improved with early therapeutic administration of a new Captisol-Enabled formulation of IV     amiodarone (Nexterone-PM101) compared to placebo.   "
143840|NCT01401634|"     Diabetes and high blood sugar are extremely common among patients presenting to US Emergency     Departments. Intravenous fluids with or without insulin are often used to treat these     patients. However, simple, low-cost interventions, such oral hydration have not been studied     in this context. Oral rehydration may be better than no therapy at all, which is often what     these patients receive in the first few hours when presenting to busy, overcrowded Emergency     Department (ED) with long wait times, or in resource-poor environments such as developing     countries. The investigators propose a study to see if oral hydration for adult patients     presenting to the ED with high blood sugar i.e. finger-stick (FS) values between 250 and 500     mg/dL can help lower blood sugar at the same rate as intravenous fluids. Half the patients     will be given intravenous fluids per our department protocol, while the other half of the     patients will be given 2 liters of water to drink over a 1-hour period. Both groups will have     their blood sugar measured every 30 mins for 2 hours. The investigators will analyze the data     to determine if there is a statistically significant difference in blood sugar between the     two groups within 2 hours.   "
143841|NCT01401621|"     The goal of this project is to determine whether prompting the recipient of a health reminder     mailing to scratch off targeted area.   "
143842|NCT01401608|"     This study will assess the outcomes of using magnetic navigation to treat ventricular     tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons     and are not related to structural heart disease.   "
143843|NCT01401595|"     The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in     the treatment of the Night Eating Syndrome.   "
143844|NCT01401582|"     Caring for people with dementia and treating them is a major challenge for the health care     system in Germany. Among the challenges for population-based health care research are (a)     identification and early recognition, (b) multimorbidity and (c) the integration of persons     with dementia into the health care system. One setting which is identified to meet the     challenges is the primary care setting and there especially the general physician. There have     been a few interventional studies, which have been restricted to selective samples and have     been conducted in inpatient settings.      The purpose of this study is to test the efficacy of implementing a subsidiary support system     for persons with dementia living at home. This subsidiary support system is initiated by a     Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main goals     are to improve quality of life and health care of the person with dementia and reduce     caregiver´s burden.      The study is a general physician based cluster-randomised controlled intervention trial. A     population based sample of general physicians will be asked to participate in a systematic     screening trial to identify people with dementia in primary care in Mecklenburg Western     Pommerania (MV), a federal state in Germany. Upon identification the people will be asked to     participate in the DelpHi-MV study and after having given written informed consent will then     be assigned to an intervention and a control group. Identification of people with dementia     will be achieved by a short screening questionnaire in the physician's office. An extended     in-depth data assessment will be conducted after inclusion into the study and then annually     to measure the course of the people's health. Data assessment will be done at the people's     homes.      People assigned to the intervention group will receive an intervention provided by Dementia     Care Manager. The Dementia Care Manager is a specialised nurse that is going into the     person's home to manage the care of dementia as well as caring for the person's relative/ or     carer.   "
143845|NCT01401569|"     This study investigated the efficacy of an exercise and counseling intervention for depressed     smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8)     in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of     intervention: individually delivered exercise and counseling (for smoking cessation and     physical activity) or control: health education contact control condition.   "
143846|NCT01401556|"     The objective of the proposed research is to improve quality of care for older outpatients     who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist     or other upper extremity fracture. Although most of these patients warrant evidence-based and     guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate     treatment rates less than 10-20% in the year post-fracture. Several trials, including the     investigators own prior studies, have tried to address this osteoporosis care-gap and have     reported that various multifaceted interventions (combinations of patient and physician     education, guidelines, and physician reminders) can modestly improve treatment rates compared     with usual care, although 60-70% of the patients exposed to these interventions still remain     untreated. The investigators believe that a case-manager (who identifies and independently     sees patients in clinic, arranges bone mineral density [BMD] tests, and offers     guideline-based treatment to those with low BMD) represents a potential solution that holds     great promise.      The investigators hypothesize that an osteoporosis case-manager will effectively and     efficiently increase rates of osteoporosis treatment in older outpatients with upper     extremity fractures when compared with a documented effective and cost-saving multifaceted     intervention. To test this hypothesis the investigators propose a pragmatic patient-level     randomized controlled comparative effectiveness trial with blinded outcomes ascertainment     that compares the case-manager strategy with the multifaceted intervention.   "
143847|NCT01401543|"     This study compares LY2452473 taken orally as a 5 mg capsule at the same time as a 5 mg     tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5     mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and tadalafil     circulating in the blood for each treatment. Side effects will be documented. This study is     approximately 34 days not including screening.   "
143848|NCT01401530|"     The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through     observation of dose limiting toxicity (DLT), which is in advance defined, in patients with     peripheral or cutaneous T-cell lymphoma.   "
144295|NCT01395693|"     Assessment of the performance of the Salt Lake mask system acting as a patient interface in     the provision of PAP therapy. This study will assess the suitability of this mask system in     its current form for use.   "
143851|NCT01401491|"     Clozapine has been virtually the only psychopharmacological choice in patients with     schizophrenia who either did not response to typical neuroleptics or experienced severe     extrapyramidal side effects and consequently did not tolerate this medication. There are     patients who do not respond to clozapine, and the need to treat these severely ill patients     frequently compels clinicians to adopt therapeutic innovations that lack a sound empirical     basis. One strategy is the combination of various other somatic treatments with clozapine.      Recently, the investigators conduct a preliminary open trial to evaluate the safety and     efficacy of fluvoxamine coadministration with clozapine in refractory schizophrenic patients.     The combined treatment is well tolerated, and clinical improvement is observed in our     patients. And the concomitant fluvoxamine could attenuate the clozapine-induced weight gain     and metabolic disturbance. However, the effects of fluvoxamine on the safety and therapeutic     efficacy of clozapine need to be further clarified in double-blind study.   "
143852|NCT01401478|"     Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at     thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5     Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the     study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be     assessed during the study.   "
143853|NCT01401465|"     This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with     perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy     of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel     patient-administered assessment, developed and validated to measure patient satisfaction with     and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis     (AR), is utilized in this study.   "
143854|NCT01401452|"     The aim of this post-marketing observational study (PMOS) is the assessment of effectiveness     of Adalimumab in moderate to severe Plaque Psoriasis patients with distinct co-morbidities     and impact of Adalimumab on the quality of life in routine clinical praxis over the period of     9 month. Psoriasis is associated with several co-morbidities such as depression, obesity and     metabolic syndrome. Until now it is unclear if these co-morbidities are due to the     pathophysiology of psoriasis or psoriasis-associated behaviors (e.g. smoking and alcohol     abuse). Disease severity is correlated with smoking and alcohol abuse. The severity of     psoriasis shall be established before and under treatment of Adalimumab by calculation of the     Psoriasis Area Severity Index (PASI) and the analysis of Dermatology Life Quality Index     (DLQI) in Patients with at last one co-morbid disease and/or symptom. Also the prevalence of     co-morbidities in consideration of gender and other parameters of Life Quality (SF-36) and     Life-Quality for specific co-morbidities should be evaluated.   "
143855|NCT01401439|"     The purpose of this study is to find out whether measurement of body composition has a     prognostic value on clinical and overall outcome in pediatric patients with cystic fibrosis.   "
143856|NCT01401426|"     Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been     approved as a treatment of morbid obesity. The standard laparoscopic operation requires five     small incisions for the introduction of instruments and the band into the patient's abdomen.     The investigators have developed a technique for performing this operation through a single     incision at the belly button. This study compares this method to the conventional 5-incision     approach.   "
143857|NCT01401413|"     The purpose of this study is to determine whether the use of the drug ramelteon decreases the     symptoms of REM Sleep Behavior Disorder.   "
143858|NCT01401400|"     Background and rationale Chronic hepatitis B is the most common cause of liver cirrhosis and     hepatocellular carcinoma worldwide.(1) Antiviral therapy with oral nucleoside analogs and     interferon can reduce viral load and hepatic necroinflammation, and may reduce the risk of     hepatocellular carcinoma and cirrhotic complications. (2-4) Peginterferon has both direct     antiviral and immunomodulatory effects. The advantages of this drug include a finite course     of treatment and the lack of drug resistance. However, it requires subcutaneous injections     and carries some side effects. Besides, only 30% to 40% of treated patients have sustained     response to treatment.(5-8) To reduce the costs and side effects of treatment, it is     important to predict if a patient will respond to peginterferon. Genetic host studies on     peginterferon response will provide a lot of knowledge on the interaction between the host     and the virus to induce immune control, also outside the setting of immune modifying therapy.     Recently, genome wide association studies (GWAS) identified genetic polymorphisms of the     IL28B gene that were shown to be associated with treatment response to interferon and     ribavirin in patients with chronic hepatitis C.(9-12) The same polymorphisms are also     associated with natural clearance of hepatitis C virus. Whether the same phenomenon applies     to patients with chronic hepatitis B is unclear. Furthermore, response to conventional     interferon has shown to decrease the risk of hepatocellular carcinoma and to prolong     survival.(13) Virological and serological response to PEG-IFN is durable in a substantial     proportion of patients through 3 years of follow-up (14), but whether treatment benefits are     sustained after that period and amount to clinically meaningful results is unknown. To date,     a GWAS to predict the response to peginterferon in chronic hepatitis B patients has not been     performed. Polymorphisms in genes such as IL28B can be identified through a GWAS and can be     used to assess the chance of response to treatment and select patients who have a high     probability of response to peginterferon.      We aim to perform a GWAS in chronic hepatitis B patients previously treated with     peginterferon to identify polymorphisms in genes that are associated with response to this     treatment regimen.   "
143859|NCT01401387|"     This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical     and mental health status and survival of patients who are diagnosed with pancreatic cancer     and are highly likely to develop exocrine pancreatic insufficiency during their disease     process.   "
143860|NCT01401374|"     The study is an on-line survey posted on survey monkey that addresses some demographic and     environmental issues that could potentially relate to vitiligo vulgaris onset or disease     exacerbation.   "
143861|NCT01401361|"     To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction     with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter        -  Does not result into unacceptable risk of intra-procedural composite serious adverse          events and,        -  Does not affect efficacy of the ablation procedure The study will also evaluate the   "
143862|NCT01401348|"     A research study to evaluate the effect of aging and HIV on neurocognitive dysfunction     (declining ability to process information), physical frailty and heart disease. HIV-infected     participants whose virus is controlled on antiretroviral medications will be studied to     determine the rates and risk factors of developing these conditions.   "
143863|NCT01401335|"     The investigators propose a prospective single arm pilot cohort study of 100 youth (ages     15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be     enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a     district of the Southern province, in Rwanda.   "
143864|NCT01401322|"     Time-to-Progression (TTP)   "
143866|NCT01401296|"     200 persons with depression are recruited via internet depression forums devoted to     depression and are randomly assigned either to the online program deprexis or to a wait-list     control condition. All participants receive free-of-charge online access to deprexis either     immediately or with an eight week delay.      Prior to intervention and eight weeks later, both groups are assessed via an anonymous online     survey which was implemented using the software package OPST®. The survey consists of     different questionnaires. The Beck Depression Inventory (BDI) represents the primary outcome.     It is assumed that the severity of depressive symptoms will improve to a significantly     greater extent in the deprexis than in the wait-list control condition in the course of eight     weeks.   "
143867|NCT01401283|"     This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac     index trending via a radial arterial line versus standard care in general surgical patients   "
143868|NCT01401270|"     The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6     conditions: (a) a control group, (b) a contingency management condition that arranges a 100%     probability of winning a prize with each draw and has 3 prize categories, (c) a contingency     management condition that arranges a 31% probability of winning and has 3 prize categories,     (d) a contingency management condition that arranges a 100% probability of winning and has 7     prize categories, (e) a contingency management condition that arranges a 31% probability of     winning and has 7 prize categories, or (f) usual prize contingency management with a 50%     probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical     across conditions, but lower overall probability conditions arrange for greater chances of     winning larger magnitude prizes. The investigators expect that the new contingency management     conditions will reduce cocaine use relative to the control condition, that 31% probability     conditions will decrease drug use relative to 100% conditions, and that 7-prize category     conditions will reduce drug use compared to 3-prize category conditions. In addition, the     31%/7-category condition is expected to be most efficacious. Results will be instrumental for     further developing prize contingency management to improve outcomes of cocaine-dependent     methadone patients.   "
143869|NCT01401257|"     The present trial is a randomized, placebo-controlled study evaluating 3 different doses of     PXT3003 in patients with CMT1A disease.   "
143870|NCT01401244|"     This trial is conducted in United States of America (USA). The aim of this trial is to     examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.   "
143871|NCT01401231|"     This pilot study will examine the feasibility, acceptability, and effectiveness of a brief     behavioral activation psychotherapy for women with perinatal depression.   "
143872|NCT01401218|"     Postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic     aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases     the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies     for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore,     the investigators tried to evaluate the incidence and risk factors of AKI after thoracic     aortic surgery according to the diagnostic criteria and staging system of AKI reported from     acute kidney injury network. The investigators also tried to develop a risk model with     scoring system of AKI and evaluate the performance of the risk model.   "
143873|NCT01401205|"     The investigators applied upper airway ultrasonographic examination focusing the measurement     of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate     the change of upper airway anatomy before and after the surgery. The investigators also tried     to find any findings of ultrasonographic examination that could reliably predict the dyspnea     or airway compression after extubation. The investigators tried to compare the     ultrasonographic findings with those of chest radiograph to validate the measurements of the     ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to     predict the upper airway obstruction in shoulder arthroscopic surgery.   "
143874|NCT01401192|"     This study trys to evaluate the predictive role of thymidylate synthase expression for     pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).   "
143875|NCT01401179|"     The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis     and neonatal morbidity and mortality, and to review the evidence and provide recommendations     on the use of antibiotics in PPROM.   "
143876|NCT01401166|"     This randomized, open-label, crossover study will evaluate participants' preference and     healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in     HER2-positive early breast cancer. Participants will be randomized to receive either SC     Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other     treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18     cycles), participants will receive IV or SC Herceptin every 3 weeks.   "
143877|NCT01401153|"     Major aim of this study is to add scientifically proven insights into cognitive effects of     meals to the existing recommendations for school meals in Germany. As a first step the     short-term effects of skipping lunch on children's cognitive functioning in the afternoon     will be examined in a cross-over trial. The study is conducted in a large comprehensive     school in Gelsenkirchen (Germany) including about 150 children.   "
143878|NCT01401140|"     An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary     revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac     surgical interventions, it is performed with the heart stopped; this leads to more or less     severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a     duration that varies depending on the number of bypasses required, and on the local     difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes.     Heart protection during coronary revascularization surgery remains a crucial factor in     limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting     post-operatory ventricular dysfunction. Its quality is a determining factor of the     post-operatory issue.      High-performance heart protection solutions such as Custodiol have been used by heart     surgeons for a few years. They are used as an alternative choice to other cardioplegic     solutions, the efficacy of which has already been proven (St Thomas). These two myocardial     protection solutions have never been evaluated in an in vivo, randomized, comparative trial.   "
143879|NCT01401127|"     People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but     problems with metabolism and blood glucose control can make this difficult. Some people with     T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous     insulin infusion (CSII) therapy, in which a background or basal level of insulin is     constantly infused under the skin by a special pump, with bolus doses of insulin given to     accompany food. Clinical experience suggests that this may be particularly useful for     managing diabetes for exercise, but there is limited experimental evidence to support this.     The aim of this research , which is divided into three parts, is to investigate the     hypothesis that the physiological response to sub-maximal (moderate) exercise of a person     with type 1 diabetes treated with CSII, can be made to approximate more closely to the     physiological response of a healthy individual by a prior reduction of their basal insulin     infusion rate. This first part of the research is designed to compare metabolic response to     exercise between people without diabetes and people with T1DM running there insulin pump at     the usual basal rate.   "
143880|NCT01401114|"     This study is a regulatory post marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Wellnara for postmenopausal     osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara     in clinical practice. A total 400 patients will be recruited and followed 3 years since     starting Wellnara administration.   "
143881|NCT01401101|"     The purpose of this study is to conduct a randomized trial of a Post Traumatic Stress     Disorder (PTSD) Care Management (PCM) program to detect, treat, and improve PTSD treatment     processes and outcomes in patients seeking primary care from FQHCs and evaluate its     effectiveness on improving the processes and outcomes of care for PTSD.   "
143882|NCT01401088|"     The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial     Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory     glaucoma.   "
143883|NCT01401075|"     Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus,     aVQ) in patients with gastric cancer receiving oral chemotherapy.   "
143884|NCT01401062|"     The purpose of this study is to test safety of combining fresolimumab and local radiotherapy     and to see if the combination can achieve tumor regression.   "
143885|NCT01401049|"     The purpose of this study is to compare the incidence and intensity of possible pain on     injection as well as patient satisfaction caused by propofol (a lipid based medication);     Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a     local anesthetic commonly used with propofol injection).   "
143886|NCT01401036|"     Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated     stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting     Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction     (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI     between patients receiving Nobori versus uncoated stents.   "
143887|NCT01401023|"     This is a prospective, non-comparative, interventional, observational pilot study of the     safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral     therapy in patients with known mild to severe confirmed Clostridium difficile associated     diarrhea (CDAD).   "
143888|NCT01401010|"     Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic     patients.      Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported     as Probability of Target Attainment (40% Time (fT)> minimum inhibitory concentration (MIC))   "
143889|NCT01400997|"     This is Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy     in paediatric subjects using easypod™ electromechanical device for growth hormone treatment     to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
143890|NCT01400984|"     This is a Slovakian, Multicentre, Observational Study to study Adherence and Long Term     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth     hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
143891|NCT01400971|"     The purpose of this study is to identify specific patient, physician, and health system     related factors associated with the progression to a more intensive regimen from initial     insulin therapy for patients with type 2 diabetes.   "
143892|NCT01400958|"     The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people     receiving external beam radiation therapy for the treatment of malignant gliomas. It is also     being done to determine if Nuvigil® improves cognitive function (perception, thinking,     reasoning, and remembering) and overall quality of life in people receiving external beam     radiation therapy for the treatment of malignant gliomas. Another purpose of this study is to     see if people who receive Nuvigil® have more or less side effects than people who receive     placebo. Placebo is a substance that looks like an active drug but has no active ingredient.   "
143893|NCT01400945|"     The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD)     patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.   "
143894|NCT01400932|"     This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study     in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl     peroxide [BPO] 3% gel) when applied once daily for 12 weeks. This study will also evaluate     the safety of GI148512 when applied topically once daily for 12 weeks.   "
143895|NCT01400919|"     The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming     the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™     Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common     and/or external iliac arteries.   "
143916|NCT01400646|"     The purpose of this study is to explore the pharmacodynamic (what the drug does to the body)     changes when transitioning from rivaroxaban 20 mg once daily to warfarin dosed to a     therapeutic level as measured by the International Normalized Ratio (INR) range of 2.0 to 3.0     in healthy volunteers. In addition, the pharmacokinetics (what the body does to the drug),     safety and tolerability of rivaroxaban during the transition to warfarin will be     investigated. The INR is obtained from a blood test, and is a measure for the clotting     tendency of the blood used for safe and adequate dosing of warfarin.   "
143896|NCT01400906|"     People with asthma suffer from breathlessness because the small tubes (bronchioles) that     carry air in and out of the lungs become inflamed and narrow. Steroids reduce the     inflammation, and are commonly used to control asthma, but they do not work well in some     asthmatics, particularly those who smoke.      This study is done to find out more about why smokers with asthma do not benefit from steroid     treatment. In this study, the effect of Flixotide (fluticasone propionate), a steroid widely     used to treat asthma, is tested in smokers and non-smokers with mild asthma.      16 smokers and 16 non-smokers, aged 18−55 years will be enrolled in this study.      Subjects will take each of the following treatments:        -  100 micrograms Flixotide twice daily for 7 days;        -  500 micrograms Flixotide twice daily for 7 days; and        -  placebo (dummy medicine) twice daily for 7 days.      Study design: subjects will have a screening visit (over 2 days), and will take part in 3     treatment periods (which are separated by interval of at least 14 days); a follow-up visit is     scheduled 7 days after the last intake of study treatment.      The order in which order the subjects will take the treatments is defined at random. Total     study duration: about 11 weeks.      To test the effects of Flixotide, the subject's responses to :        -  an inhaled allergen test        -  a PC20 methacholine test        -  blood, urine and sputum PD markers will be analysed.      This study will take place in 2 centres: 1 in the United Kingdom and 1 in Belgium. The units     will recruit participants by advertising (newspaper, radio, and websites), word of mouth,     from volunteer databases, and via the centres' websites.   "
143897|NCT01400893|"     The purpose of this protocol is to evaluate the safety of a selective cytopheretic device     (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney     injury (AKI).   "
143898|NCT01400880|"     The specific goal of the proposed research is to develop a reliable, non-invasive fetal and     maternal heart rate and contraction monitor that is unaffected by obesity and requires less     nursing intervention than the tocodynamometer and Doppler ultrasound.   "
143899|NCT01400867|"     This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil     in children with skin infections receiving antibiotic therapy in the hospital.   "
143900|NCT01400854|"     Aim of this non-interventional study is to investigate the tolerability of Effentora® in     cancer pain patients with breakthrough pain under real-life conditions in clinical practice.   "
143901|NCT01400841|"     This investigation is a prospective, non-randomized, multi-center trial to evaluate the     safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically     repair a leaking aortic valve using a 3-D intra-annular mounting frame   "
143902|NCT01400828|"     The objective of the study was to determine the efficacy and tolerability of 20 mg of     Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic     Rhinitis.   "
143903|NCT01400815|"     A randomized, active controlled clinical trial in which a total of 216 healthy smokers will     be enrolled and followed over approximately 19 weeks.      The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid.      Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be     randomized in a 1:1 ratio to 1 of the 2 treatment arms:        -  Group 1: X-22 Cigarettes (very low nicotine)        -  Group 2: Active Control Cigarettes The randomization will be stratified by gender.          Efficacy will be assessed by analysis of cigarette consumption using self-report diaries          and measurement of exhaled CO and cotinine concentrations.      Safety will be assessed by evaluation of adverse events, physical examinations, clinical     laboratory tests, and measurement of heart rate, blood pressure, and body weight at each     study visit.   "
143904|NCT01400802|"     The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro     Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter     (PK) and the pharmacodynamic parameter (PD).   "
143905|NCT01400789|"     The aim of this study is to assess the bioequivalence of two premixed formulations of insulin     Lispro, Humalog Mix50/50® and ListroMix 50/50® in healthy subjects based on the     pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).   "
143906|NCT01400776|"     Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due     to vulvovaginal atrophy.   "
143907|NCT01400763|"     Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are     members of the carotenoid family. Epidemiological evidence indicates that a higher intake of     lutein and zeaxanthin is associated with a lower risk to develop age-related macular     degeneration (AMD). The lipid matrix of an egg yolk is an excellent vehicle for the efficient     absorption of dietary lutein and it is possible to increase the natural lutein concentration     in an egg yolk. A fresh lutein-enriched egg yolk beverage has been produced using these     lutein-enriched egg-yolks. However, this beverage has a limited shelf life of maximum three     weeks. Drying this fresh beverage extents the shelf live, however, this should be without     loosing its functional properties concerning lutein bioavailability. At WUR-FBR two types of     drying procedures have been evaluated resulting in two different dried product formulations,     which need to be tested. The question is, whether the lutein bioavailability is not affected     by different drying procedures.   "
143908|NCT01400750|"     Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone     chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new     Pa infection.   "
143917|NCT01400633|"     The purpose of this study is to investigate the overall response rate (ORR) and safety when     treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be     administered as long as there is evidence of clinical benefit.   "
143918|NCT01400620|"     The purpose of this study is to determine whether an oral rinse composed of botanical     extracts is effective in the prevention of severe inflammation of the lining of the oral     cavity caused by chemotherapy and radiation therapy for head and neck cancer.   "
143920|NCT01400594|"     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of     HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.   "
144524|NCT01392716|"     This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in     treatment-naive patients with non-bulky follicular non-Hodgkin`s lymphoma. The anticipated     time on study treatment is 3 months.   "
143909|NCT01400737|"     Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in     extremely premature infants less than 28 weeks. The clinical signs and symptoms of PDA in     preterm infants are non specific and insensitive for making an early diagnosis of significant     ductal shunting. Functional echocardiography is emerging as a new valuable bedside tool for     early diagnosis of hemodynamically significant ductus, even though there are no universally     accepted criteria for grading the hemodynamic significance. Echocardiography has also been     used for early targeted treatment of ductus arterioses, though the long term benefits of such     strategy are debatable. The biomarkers like BNP and N- terminal pro-BNP are currently under     research as diagnostic marker of PDA. The primary mode of treatment for PDA is     pharmacological closure using cyclo-oxygenase inhibitors with closure rate of 70-80%. Oral     ibuprofen is emerging as a better alternative especially in Indian scenario where parenteral     preparations of indomethacin are unavailable and side effects are comparatively lesser.     Though pharmacological closure of PDA is an established treatment modality, there is still     lack of evidence for long term benefits of such therapy as well as there is some evidence for     the possible adverse effects like increased ROP and BPD rates, especially if treated     prophylactically.The aim of this study is to investigate the effect of oral ibuprofen     prophylaxis administrated on the first 24 hours of life and the following two days on     hemodynamically significant patent ductus arterioses and its long term effects such as ROP     and BPD.   "
143910|NCT01400724|"     A prospective, randomized, controlled, open-label study will be carried out on 80     post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP     III). After a written informed consent, women will be randomly treated for 6 months with     hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg     plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty     post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40     treated with myo-inositol 2 g twice per day and forty treated with placebo for six months.     The investigators hypothesize that the administration of myo-inositol would improve the     insulin-receptor activity in these women, reducing insulin resistance.   "
143911|NCT01400711|"     Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating     the stress response to surgery and enabling rapid recovery. There is strong evidence of the     usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of     significantly reduced postoperative complications and shorter length of hospital stay,     compared to the patients of traditional treatment. However, few studies exist about the     implication of ERAS programs in major upper abdominal surgery patients.      The aim of this study was to compare morbidity, mortality and length of stay in patients     undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving     either conventional postoperative care or an ERAS program.   "
143912|NCT01400698|"     Study of safety of Saizen® in children born with serious intra-uterine growth retardation     (IUGR) treated to final height. An open, phase III study involving 17 centers in France.      The study enrolled children who have completed 3 or 2 years of treatment and at least one     year of post treatment observation in the Sponsor Studies GF 4001 (Safety and Efficacy of     Saizen in the Treatment of Young Children Born with Severe IUGR) or GF 6283 (Effect of     Intermittent versus Continuous Saizen Therapy in Young Children Born with Severe IUGR),     respectively.      Detailed description: Serious IUGR is a syndrome characterized by low birth length and weight     for gestational age (less than 10 percentile). The secretion of growth hormone in response to     provocative stimuli (e.g. arginine, insulin) is normal in these children. Apart from low     birth weight, children born with IUGR may have minor or major malformations.      A catch-up period with a supraphysiological growth velocity generally occurs during the first     6 to 24 months of life in 80 to 90 percent (%) of these children. This generally allows them     to reach normal height. That means that conversely, approximately 10 to 20% of children do     maintain a statural handicap. Puberty occurs at a normal age and the retardation in bone     maturation present during the first years of life disappears very quickly. This leads to     short adult stature in subjects who have not shown spontaneous catch-up during the first     years of life. A safe and effective means of promoting growth without accelerating the timing     or tempo of puberty would therefore be desirable.   "
143913|NCT01400685|"     Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify     or regulate the functioning of the immune system. It is an FDA approved drug for people with     multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL),     but it does appear effective in CLL when used alone, and is being studied for use in     combination with chemotherapy in this and other lymphomas and leukemias.      In this research study we are hoping to learn more about the effects of lenalidomide on CLL     when given in combination with bendamustine and rituximab, which is a highly effective     regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest     dose of lenalidomide that can be given safely, without causing any serious or unmanageable     side effects.   "
143914|NCT01400672|"     This is a pilot/feasibility study. The study design represents a modification of current     standard of care for Diffuse Intrinsic Pontine Glioma (DIPG) (5580 cGY involved field     radiation), with the final two doses of radiation given at intervals during the vaccination     phase of treatment.      Patients between the ages of 3 years and 25 years diagnosed with Diffuse Intrinsic Pontine     Glioma (DIPG) will be allowed to participate in the trial. Study enrollment will occur after     the completion of conformal radiation therapy to a dose of 5580 cGy and the post radiation     therapy (RT) magnetic resonance imaging (MRI) shows no disease progression.      Three patients with glioblastoma multiforme, aged 16 years and older, will be entered first     to confirm vaccine safety before enrolling DIPG patients.   "
143915|NCT01400659|"     The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein     (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus in     sensor-augmented pump therapy in children and adolescents with type 1 diabetes. For     fat/protein counting the model used by Pankowska et al. will be applied.   "
143921|NCT01400581|"     The purpose of this study is to evaluate the effectiveness of a collaborative care     intervention for evidence based management of alcohol use disorders in primary care settings     within the Veterans Administration Puget Sound Health Care System (Seattle and American Lake     Divisions). The study will test whether patients offered the collaborative care intervention     have fewer heavy drinking days at 12 months follow-up and to be abstinent or drinking below     recommended limits without problems.   "
143922|NCT01400568|"     This pilot study is planned to assess the suitability of a low dose Lipopolysaccharide (LPS)     inhalation as a challenge model. As LPS effects are based on a different mode of action, this     challenge model will provide the possibility to test a wider spectrum of potential drugs in     the future. Provided that the LPS response is reproducible, it is planned to test whether a     single high dose of inhaled steroid can serve as a positive control in the LPS model. Another     major aim of the study is to test a variety of novel tools for the non-invasive assessment of     airway inflammation induced by LPS challenge.   "
143923|NCT01400555|"     The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate     administered in combination with docetaxel plus prednisone in patients with metastatic     castration-resistant prostate cancer (mCRPC).   "
143924|NCT01400542|"     Obstructive sleep apnea (OSA) is much more common in the elderly than in the young; the     latest studies show prevalence between 45% and 62% in individuals over 60. It is even higher     in patients with dementia such as Alzheimer patients.      Several trials in elderly patients showed modified cognitive functions, particularly     executive and attentional functions, in patients with respiratory sleep disorder. However the     benefit of CPAP (Continuous Positive Airway Pressure) ventilation for Alzheimer patients is     still controversial, as there are few studies documenting its effects on dementia patients'     cognitive abilities, and clinicians appear reluctant to prescribe this type of treatment.      The investigators must keep in mind that Alzheimer patients suffer significant sleep     disorders; advanced- stage patients spend 40% of the night awake and are drowsy a large part     of the day. In dementia patients, sleep disorder is a major cause of hospitalization and     institutionalization. The prevalence of obstructive sleep apnea (OSA) in this population is     estimated at over 50%, and appears to be higher the more advanced the dementia. Trials on     obstructive sleep apnea syndromes in Alzheimer patients show significatively improved scores     on the apnea-hypopnea index (AHI), as well as satisfactory treatment tolerance. However, any     impact on cognitive abilities has yet to be demonstrated.      In addition, cardiovascular pathologies such as arterial hypertension, cardiac arrhythmias,     and strokes are strongly correlated to OSA. In light of its consequences on morbidity and     mortality, OSA should be considered a public health issue.      In this context, the investigators wish to address the impact of CPAP treatment     implementation on the cognitive parameters of patients diagnosed with OSA, particularly on     their executive functions. This should provide evidence for mid-term assessment of the     benefits of CPAP in caring for elderly patients with dementia.      In light of the prevalence of obstructive sleep pathologies in elderly patients reported in     various studies and of the potential impact of CPAP treatment on cognitive abilities, the     investigators propose a study to evaluate the impact of OSA treatment on elderly Alzheimer     patients' cognitive abilities, particularly on their executive functions.      Executive functions are a rather heterogenous group of high-level cognitive processes which     enable individuals to adopt a flexible, context-appropriate behavior. They also include     planning abilities, working memory, cognitive control, abstract thought, rule learning,     selective attention, motor response selection, etc... Executive functions are mainly     associated to the functioning of the brain's frontal lobes, although subcortical structures     also play a role. When the executive functions are affected by disease, daily life is     significantly impeded as the individual becomes unable to perform complex tasks or regulate     his/her behavior. Many tests can help evaluate these functions in dementia patients. A number     of ecological tests, such as the zoo map test from the Behavioural Assessment of the     Dysexecutive Syndrome (BADS) arsenal, are quite relevant for evaluating executive functions.      This project aims to improve the daily life of Alzheimer patients with sleep apnea by     improving their executive cognitive functions through CPAP treatment.      According to the Paquid's trial, there are 12,400 Alzheimer patients in the French Loire     department. [27] The study population will therefore be recruited in the La Charité center     of CHU Saint-Etienne. The target population is older individuals (≥ 65) suffering from     cognitive disorders similar to Alzheimer's disease.      OSA will be diagnosed based on polysomnography, on an outpatient basis. Apnea patients will     receive CPAP treatment for 4 months, which is the minimum duration required to implement and     accept treatment, and to measure its impact on patients' neurocognitive abilities.   "
143925|NCT01400529|"     Nationwide descriptive epidemiology survey aiming to determine lower limb OA prevalence,     based on a validated method previously used to assess inflammatory rheumatism (rheumatoid     arthritis and spondylarthropathy) prevalence in France.   "
143926|NCT01400516|"     Summary:      The investigators propose a randomized controlled open label study of teriparatide in men or     women with rheumatoid arthritis and joint erosions. Specifically, the investigators will     examine whether teriparatide in combination with a biologic can retard the development of     joint erosions. The study will be conducted at Brigham and Women's Hospital Arthritis Center,     several Brigham and Women's Hospital Arthritis Center satellite practices, the University of     Massachusetts Medical Center, and Massachusetts General Hospital.      Hypothesis:      The investigators hypothesize that the combination of teriparatide with biologic will be much     more effective at retarding erosion progression then a biologic alone.   "
143927|NCT01400503|"     The purpose of this study is to evaluate the long-term safety of siltuximab in patients with     multicentric Castleman's disease (MCD).   "
143928|NCT01400490|"     The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a     DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind,     randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of     EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg     of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel     arm design study of 120 healthy adults studied in both the fasting and post-prandial state.     Safety will be monitored by assessing for adverse reactions, measuring vital signs and a     variety of lab tests including a complete metabolic profile and complete blood count.     Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid     ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.   "
143929|NCT01400477|"     The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene     anabaseine sustained release) will provide clinical improvement in cognition in patients with     schizophrenia who are smokers and who are non-smokers. The study drug may also maintain     abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.   "
143930|NCT01400464|"     The factors underlying the large interindividual variability in response to glucocorticoids     in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of     this variability is related to pharmacokinetic factors determined by genetic polymorphism:     hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux     leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The     investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic     cohort study to assess the link between prednisolone clearance and the relapse risk in giant     cell arteritis.   "
143931|NCT01400451|"     Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of     the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and     the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and     feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison     to historical results following treatment with either agent alone.   "
143932|NCT01400438|"     Many studies have been devoted to the quality of life of patients during adjuvant     chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on     the immediate environment (spouse, children) during this difficult time for women. Curiously,     no study to date has been submitted or published about how women with a one-year treatment     extra Herceptin ® live this period in terms of quality of life, in terms of psychological     impact for themselves and their families.      The investigators have no more data on how often they return to work during this treatment or     on the psycho-social parameters which underpin them. It therefore seemed interesting to give     a spotlight on this particular period in these women HER2 + by comparing a patient     population of same age receiving the same adjuvant but with no Herceptin ®.   "
143933|NCT01400425|"     The study is designed to evaluate whether a florbetapir F 18 PET scan can impact clinical     thinking when physicians are determining the likely cause of a subject's cognitive     impairment.   "
143934|NCT01400412|"     The main purpose of this study was to compare the effects on bones of the following two drug     combinations:        -  maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r)        -  tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r)      Additional study objectives were the following:        -  To see how the drug combinations affect the brain and kidneys.        -  To see how well the drug combinations lower the HIV viral load.        -  To see how safe the drug combinations are, how well people are able to take the study          drug combinations, and how well their immune systems respond to the study drugs.   "
143935|NCT01400399|"     This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic     outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy     (BRM) followed by hypofractionated whole breast irradiation. Breast conservation is now an     established method of treatment for early breast cancer. Because breast conservation is     essentially a cosmetic alternative to mastectomy, quality of life, cosmetic outcome and tumor     control are all important considerations during comprehensive treatment planning. Irradiation     schemes have been demonstrated to be efficacious and with excellent short term cosmetic     outcomes. However, their interaction with currently evolving surgical techniques needs to be     examined in order to maintain optimal local control while preserving cosmetic outcome.   "
143936|NCT01400386|"     Coffee contributes to a large extent to our daily intake of phenolic compounds which have     been associated with potential health benefits. A study by Richelle et al. (2001), using an     LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity     which varied depending on the coffee bean source and the degree of roasting. Little is known     about the bioavailability of phenolic compounds from coffee at various roasting degrees.     Therefore, further human studies are required in order to demonstrate the absorption, and     bioavailability of metabolites that may also be efficient in vivo.      The main objective of this clinical trial is to investigate the possible difference in the     bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.   "
143937|NCT01400373|"     Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest     patients has recently been published in the PRINCE-study in Circulation 2010.      The main purpose of this study is to determine whether prehospital intra-nasal cooling     initiated during resuscitation, in addition to systemic cooling at hospital, increases     neurological intact survival measured as cerebral performance category score (CPC-score)at 90     days in witnessed cardiac arrests outside hospital.   "
143938|NCT01400360|"     Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount     of transient or even permanent neurological deficits and poor outcome of the patients.     Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators     represents a rescue therapy for severe CVS. Indication, duration and efficacy of this     treatment, however, is still under debate. Aim of the study is to investigate if such a     rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH.     Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive     intraarterial therapy to more than 50 %.   "
143939|NCT01400347|"     It is generally accepted that the effectiveness of an exercise can be controlled not only by     the weight or resistance applied but also by doing an exercise that would better target the     desired muscle. The purpose of this study is to obtain objective information regarding     selected lower extremity muscle activity during specific exercise and the influence of     fatigue and speed on muscular activation.   "
143940|NCT01400334|"     The hypothesis of PAREPET is that hibernating myocardium (viable myocardium with reduced     resting flow) and/or viable but denervated myocardium can predict the risk of sudden death in     subjects with ischemic cardiomyopathy.   "
143941|NCT01400321|"     The open, prospective, non-controlled observational study is designed to provide information     on the short-, medium- and long-term clinical performance of the Astra Tech OsseospeedTM     implant surface in combination with a special implant design. The study will provide     information on implant survival and soft tissue and bone maintenance as clinical performance     of the OsseoSpeedTM TX Profile Implant in the aesthetic zone or the posterior mandible with     socket like atrophy.   "
143942|NCT01400308|"     Multicenter Clinical Trial, experimental, randomized and prospective study to determine the     effectiveness of two protocols addressing the Corporal Decolonization in patients colonized     by Methicillin Resistant Staphylococcus Aureus (MRSA).      PRIMARY END POINT The aim of this trial is to evaluate the effectiveness of the protocol     Prontoderm® in the decolonization of MRSA patients, compared with the protocol of the     Consensus Document and GEIH-SEIMC SEMPSPH (see attached extract from the document, Annex     7).      Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and     currently available in Spain for the same indications proposed in this trial.   "
143943|NCT01400295|"     To determine a relatively safe contrast media volume to creatinine clearance cut-off value to     avoid contrast-induced nephropathy in patients following coronary angiography   "
143944|NCT01400282|"     The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and     sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation     (Conv SCS) on the patient reported global impression of change, pain intensity and health     related quality of life.   "
143945|NCT01400269|"     The purpose of this study is to assess the efficacy of a parent training program in the     treatment of social and communication deficits in children with autism. Specifically, this     study will evaluate a developmentally based parent delivered intervention in the community     developed by Pacific Autism Center for Education (PACE).   "
143946|NCT01400256|"     The investigators hope to show that valsartan can be used safely in the setting of acute     stroke to lower elevated blood pressure. There are novel properties of this class of drug (an     angiotensive-receptor blocker or ARB), and promising human and animal data, that would     suggest this drug can be safely used to lower blood pressure in the setting of acute stroke     without compromising brain blood flow (i.e. cerebral perfusion). If this is proved to be the     case, this compound could potentially be used routinely in this setting, with the hope of     improving outcome. This pilot study may pave the way for a larger randomized trial looking at     outcome measures in stroke patients. Further, a positive result in the this pilot study will     serve as proof of concept that ARBs maintain cerebral perfusion while decreasing blood     pressure, an overall favorable property.   "
143947|NCT01400243|"     The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus     placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a     randomized, double-blind, and placebo-controlled design. This proposal is in response to     RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with     the goals of this RFA, the overall goal of the proposed project is to assess the impact of     transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving     motivated by negative affect) symptoms in MJ-dependent individuals.   "
143948|NCT01400230|"     Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect     ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive     techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic     intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess     precise anatomical information. Optimal functional criteria and their accuracy of IVUS and     CCTA by fraction flow reserve (FFR) have not been compared yet.   "
143962|NCT01400048|"     The purpose of the present study is to study the effect of aloe vera in the treatment of IBS     patients in a randomized, double-blind placebo controlled study.   "
143950|NCT01400204|"     The aim of the study is to compare hangover effects of MDMA users versus those who used other     drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day     participants complete a questionnaire about the presence and severity of potential hangover     symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On     day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4     weeks, after a drug-free week, the BSI is completed again to serve as a reference.   "
143951|NCT01400191|"     The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy     Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the     study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy     volunteers with functional OCT1-transporters.   "
143952|NCT01400178|"     Objectives: To assess a group of post-lingually children after 10 years of implantation with     regard to speech perception, speech intelligibility, and academic/occupational status.      Study Design: A prospective transversal study. Setting: Pediatric referral center for     cochlear implantation. Patients: Ten post-lingually deafened children with Nucleus and Med-El     cochlear implants.      Interventions: Speech perception and speech intelligibility tests and interview.      Main Outcome Measures: The main outcome measures were score of Hint sentences recognition     (silence and noise), speech intelligibility scores(write-down intelligibility and rating     scale scores) and academic/ occupational status.   "
143953|NCT01400165|"     Generic describes a pharmaceutical product that does not have a brand name or trademark.     Generic medications should be the equivalent of brand medications. Only their price should be     different. The active ingredient of the generic medication has to be within a window of 80 to     125% of the original in the blood. There are reports that this standard is not always     followed after the medication has been on the market. Indeed, it was observed that some     patients previously stable on original medications relapsed when switched to a generic.     Several factors could account for this problem. Such problems have been reported for     Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and     the original brands will be examined for these three medications. The three original     medications used in this study are the Visken, the Seroquel, and the Desyrel. The three     generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all     available on the Canadian market by prescription.   "
143954|NCT01400152|"     Prevention and treatment of hypothermia by active warming in prehospital trauma care is     recommended but scientifical evidence of its effectiveness in a clinical setting is scarce.     The objective of this study was to evaluate the effect of additional active warming during     road or air ambulance transportation of trauma patients.      Patients were assigned to either passive warming with blankets or passive warming with     blankets with the addition of an active warming intervention using a large chemical heat pad     applied to the upper torso. Ear canal temperature, subjective sensation of cold discomfort     and vital signs were monitored.      Mean core temperatures increased from 35.1°C (95% CI; 34.7-35.5 °C) to 36.0°C (95% CI;     35.7-36.3 °C) (p<0.05) in patients assigned to passive warming only (n=22) and from 35.6°C     (95% CI; 35.2-36.0 °C) to 36.4°C (95% CI; 36.1-36.7°C) (p<0.05) in patients assigned to     additional active warming (n=26) with no significant differences between the groups. Cold     discomfort decreased in 2/3 of patients assigned to passive warming only and in all patients     assigned to additional active warming, the difference in cold discomfort change being     statistically significant (p<0.05). Patients assigned to additional active warming also     presented a statistically significant decrease in heart rate and respiratory frequency     (p<0.05).      In mildly hypothermic trauma patients, with preserved shivering capacity, adequate passive     warming is an effective treatment to establish a slow rewarming rate and to reduce cold     discomfort during prehospital transportation. However, the addition of active warming using a     chemical heat pad applied to the torso will significantly improve thermal comfort even     further and reduce the cold induced stress response.   "
143955|NCT01400139|"     The primary objective of this study is to characterize the long-term safety of Hydrocodone     Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and     nonneuropathic pain.   "
143956|NCT01400126|"     We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure     water) in comparison with the use of conventional water which are used in most dialysis units     worldwide. To the best of our knowledge prospective data in that field is sparse.   "
143957|NCT01400113|"     Our proposal is to administer asenapine to patients who are clinically agitated and in need     of immediate intervention. At present there are no controlled studies that we know of that     explores the use of asenapine for this purpose. Establishing the utility of asenapine for     this common clinical problem will support its use as an additional treatment option in     acutely agitated patients.   "
143958|NCT01400100|"     The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg     Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy     in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant.      A primary end-point of the study is a change in pancreatic texture.      A secondary end-point is the rate of postoperative pancreatic fistula.   "
143959|NCT01400087|"     The aim of this prospective randomized controlled trial is to assess the efficacy of     cap-attached colonoscopy to improve cecal intubation in comparison with regular colonoscopy     for trainees.   "
143960|NCT01400074|"     In this study, the efficacy of nilotinib at 400 mg BID will be compared with imatinib at 400     mg BID in suboptimal molecular response patients. To determine study eligibility, suboptimal     molecular response will be defined as patients who have achieved a complete cytogenetic     response (CCyR) but have not achieved a MMR, after at least 18 months of treatment on first     line imatinib therapy at a minimum dose of 400mg daily (Baccarani 2006).   "
143961|NCT01400061|"     According to our experimental experiences w hypothesized that blood boron levels may be     corralated to body mass index.   "
144031|NCT01399151|"     Hypothesis:      Volunteers with vitamin D insufficiency (serum 25(OH)D 25-50 nmol/L) given intermediate or     high dose vitamin D supplements (2,000 or 5,000 IU per day) will have increased production of     anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory     cytokines, increased production of regulatory cytokines and an enhanced T- and B-cell     response to a tetanus vaccine compared to vitamin D insufficient subjects given low dose     vitamin D supplements (400 IU per day).   "
143963|NCT01400035|"     Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an     open, randomized, multi-center control study        1. Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of          cerebral infarction        2. Design Open, randomized, multi-center control study        3. Trial Population:Patients with acute cerebral infarction        4. Number of Subjects 720 patients in test group and 240 patients in control group, totally          960 patients will be recruited.        5. Administration Test group: intravenous infusion drip of Vinpocetine 30 mg and Citicoline          0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel sulfate tablets          75mg once a day.           Control group: intravenous infusion drip of Citicoline 0.4g once daily; additionally          oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day.        6. Outcome evaluation 6.1 Primary end points: 6.1.1 Modified Rankin Scale. 6.1.2          Mini-Mental State Examination (MMSE) 6.2 Second end points 6.2.1 Barthel index 6.2.2          NIHSS score 6.2.3 Transcranial Doppler (TCD) examination 6.3 Safety data 6.3.1 Serology,          hepatic and renal function examination 6.3.2 Adverse events        7. Statistical Analysis: SPSS 11.0 will be used to make the data analysis.   "
143964|NCT01400022|"     Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital     area. Any age group may be affected, although it is seen more often in postmenopausal women.     The current gold standard treatment is topical ultrapotent corticosteroids such as     clobetasol.      Here we compare UVA1 phototherapy with 0,05% clobetasol propionate in vaseline for the     treatment of vulvar lichen sclerosus.   "
143965|NCT01400009|"     Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin     medications that have caused muscle pain for them in the past.   "
143966|NCT01399996|"     In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium     animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or     after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time);     2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human     volunteers. In addition to providing information about the relative efficacy of the delivery     vehicles on probiotic function it will provide novel information about the influence of the     yogurt smoothie alone (control) on all the parameters measured.   "
143967|NCT01399983|"     The 6 minute walk (6MW) gives information about the exercise capacity and it is an important     tool for clinical decisions and for the prognostic evaluation of PH patients. The test is     technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation,     heart rate, walking distance (in this study after every minute) and the level of dyspnea     (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is     evaluated. The test is sometimes criticized, because of the dependence on the patient's     motivation.      The purpose of the present study is to standardize the test by the incorporation of objective     factors. The investigators are correlating the change of heart rate and dyspnea (BORG scale)     with the achieved walking distance during subsequent examinations performed with different     effort.   "
143968|NCT01399970|"     The purpose of the present study is to determine whether a mobile teledermatology care model     can achieve better clinical outcomes as compared to conventional, outpatient care for the     management of severe acne treated with isotretinoin.      The superiority of mobile care in comparison to conventional, outpatient care will be     investigated regarding        1. effectiveness: Global evaluation Acne (GEA) score -response at week 24        2. safety: drop out rates and medication side effects        3. overall patient satisfaction with acne care and therapy        4. overall physician satisfaction with mobile acne care   "
143969|NCT01399957|"     Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in     persons with multiple sclerosis. This project seeks to determine if there are other benefits     to taking dalfampridine besides an increase in walking speed. This is strictly an     observational study and research staff will not be involved in any decisions to stop or start     taking the medication.   "
143970|NCT01399944|"     This single-site, within-subject, experimental study is designed to test the hypothesis that     individuals express taste receptors differently and have different sensitivities to bitter     taste samples, which results from uneven expression. Subjects will include 100 racially and     ethnically diverse, healthy adults. All subjects will provide saliva samples for genetic     analysis and undergo taste testing with common psychophysical stimuli. From the pool of 100     subjects, 36 subjects from the common heterozygous group (PAV/AVI) and two from each     homozygous group (AVI/AVI, nontaster and PAV/PAV, taster) will be invited to return for two     additional sessions. During both sessions the investigators will 1) measure bitterness     thresholds for PROP, a common psychophysical stimulus; 2) measure bitterness perception of     several vegetables; 3) obtain a saliva sample and 4) collect taste papillae. The     investigators will then isolate DNA and RNA from the taste papillae and isolate DNA from     saliva to evaluate molecular differences over time and between individuals and how it relates     to taste psychophysics. All psychophysical and cellular measurements will be done during both     sessions so that the investigators can determine how much variation is observed over a     one-week time period in both cellular phenotype and psychophysical phenotype.   "
143971|NCT01399931|"     To assess specificity and overall accuracy of interim dual-point acquisition PET in     predicting treatment outcome.      The study is aimed at assessing the specificity of interim dual-point PET performed after 2     ABVD cycles to predict treatment outcome in early-stage Hodgkin's Lymphoma patients     presenting bulky lesions at baseline.   "
143972|NCT01399918|"     The purpose of this study is to find out what effects, good and/or bad the combination of two     medications, everolimus and bevacizumab, has on kidney cancer. In this clinical trial we are     now testing these medications in combination. We think that both together might work better     that either drug alone. Importantly, both of these drugs together have been tested in     patients with a different type of kidney cancer and patients tolerated the combination well.   "
143981|NCT01399801|"     The purpose of this study is to determine if optimal lead placement, guided by the largest     improvement in aortic flow measured by Doppler will:        1. Improve the way the heart's left ventricle functions        2. Decrease the number of hospital admissions for heart failure related symptoms        3. Reduces uncoordinated heart contractions        4. Improve quality of life as measured by the Minnesota Living with Heart Failure          Questionaire and NYHA Class assessed after six months   "
143973|NCT01399905|"     Hypothesis: We hypothesize that carbidopa in daily doses of 450mg will enter the central     nervous system and partially inhibit AAAD, thereby reducing the decarboxylation of exogenous     levodopa to dopamine, and thereby blunt the therapeutic effects of levodopa in PD subjects.      The purpose of this study is to see how low dose vs. high dose of the study drug, carbidopa     effect movement in subjects with Parkinson's disease. The low dose of the study drug is 75 mg     and the high dose is 450mg.      Subjects will be recruited from the investigators clinic when they are seen for treatment for     Parkinson's disease. Subjects will also be recruited through flyers hung at OHSU and at the     VA.      Subjects will take part in 2 screening visits one week apart to determine eligibility.     Subjects will be randomly chosen to start either high or low dose carbidopa and take it for 4     weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are     doing after starting this dose of study drug. We will leave them a message if we cannot reach     them. If there are any problems, we will schedule them to come to the clinic within the next     2 days.      Subjects will have an outpatient visit 2 weeks after screening and a hospital admission 2     weeks after that. At the hospital, subjects will stay for 3 days. They will have blood drawn     and their Parkinson's disease assessed by a finger tapping exercise, timing their walking,     and looking at their uncontrolled movements.      The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects will be     called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this     dose of study drug. We will leave them a message if we cannot reach them. If there are any     problems, we will schedule them to come to the clinic within the next 2 days.      The outpatient visit and hospital admission will repeat again. At the end of the second     hospital admission, treatment on the study is over and subjects will go back to their     original Parkinson's disease medications. The study will end with a follow up phone call or     clinic visit 2 - 4 weeks after the final hospital admission.      Subjects will fill out a daily diary that asks about their movement throughout the day for 3     days before they come to the Oregon Clinical and Translational Research Institute.      Carbidopa is used for the treatment of Parkinson's disease with levodopa. This protocol is     using a high dose of 450mg of carbidopa. This study is also using IV levodopa, which is a     different route than is normally given.      Finger tapping rates will be compared between high and low dose study drug use to see if one     group has slower rates than the other.   "
143974|NCT01399892|"     High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition     Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay     glucose absorption and reduce postprandial glycemic excursion. They also appear to have a     beneficial effect on cholesterol levels. It has been shown, in few short term adult studies,     that high fiber foods reduce postprandial blood glucose levels. The American Diabetes     Association feels that there is little evidence confirming the positive effect of high fiber     foods on blood glucose control. It is not clear whether a high fiber diet can improve     glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that     children with type 1 diabetes will benefit from having added fibers in their diet. The     investigators plan to study blood glucose values using a continuous blood glucose monitor     before and after dietary fibers are introduced. This will help us determine whether a diet     rich in fiber should be recommended in all children with type 1 diabetes mellitus   "
143975|NCT01399879|"     The Scanning Kelvin Probe measures surface electrical potential without actually touching the     skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin     Probe measurements. This project will focus specifically on noise arising from physical     movement and environmental electrical field.   "
143976|NCT01399866|"     One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to     a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to     prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria,     and demonstrate response to cue reactivity at the screening visit, will either be:        -  started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose          of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which          method to use to quit smoking will be based on participant choice as well as taking into          account any medical contraindications to either therapy.        -  evaluated to confirm abstinence from smoking. Recently abstinent participants referred          by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm          to confirm abstinence.      Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue     Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study     medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete     2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study     involves twelve visits and will last approximately ten weeks. For recently abstinent     participants referred by a smoking cessation clinic, PCP or self referred, the study involves     7 visits (screening and baseline visit will be merged into one and there is no CBT component)     and will last approximately 7 weeks.   "
143977|NCT01399853|"     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused     by viruses that belong to the enterovirus genus of the picornavirus family. Although most     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71     (EV71) can present with a high rate of neurological complications, including     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic     potential of EV71 clearly requires the attention of world medical community.      The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in     Jiangsu Province in China. The data from the phase I study suggested that the inactivated     EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese     children and infants. In order to provide more evidence for the immunogenicity of the     vaccine, to further explore the probable immunizing dose and the safety profile of this     vaccine, a phase II clinical trial is planed to conduct.   "
143978|NCT01399840|"     This is a two-arm, open-label study to determine the maximum tolerated dose (MTD) and assess     the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMN 673 in     patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic     Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL). Arm 1 will enroll patients with     either AML or MDS; Arm 2 will enroll patients with either CLL or MCL.   "
143979|NCT01399827|"     The purpose of this study is to a) assess the efficacy of omega-3 fatty acids in the     treatment of Deficient Emotional Self-Regulation (DESR) among stimulant treated Attention     Deficit Hyperactivity Disorder (ADHD) adults, b) assess the side effect profile of omega-3     fatty acids in the treatment of DESR among stimulant treated ADHD adults, c) assess effects     of omega-3 fatty acid supplementation on ADHD symptoms and associated features in stimulant     treated ADHD adults, and d) predict value of fatty acids present in RBC cell membranes. This     study will be a 12-week trial with adults 18-55 years of age with ADHD and symptoms of DESR.   "
143980|NCT01399814|"     The purpose of this study is to find out whether perioperative fluid restriction influence on     postoperative immunological function. And discuss the probable mechanism that fluid     restriction regime effect on clinical data.   "
143982|NCT01399788|"     This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against     reference drug in healthy volunteers.   "
143986|NCT01399736|"     The Compare-Acute trial is a prospective randomised trial in patients with multivessel     disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The     purpose of the study is to compare a FFR guided multivessel PCI taking place during the     primary PCI with a primary PCI of the culprit vessel only.      Patients will be enrolled after successful revascularisation of the culprit vessel. Patients     that have at least one lesion with a diameter of stenosis of more than 50% on visual     estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related     artery, will be randomised either to the FFR guided complete revascularisation arm or staged     revascularisation by proven ischemia or persistence of symptoms of angina.      Approximately 885 patients will be entered in the study.      Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting     stenoses in the non-IRA performed within the same procedure as the primary PCI or within the     same hospitalisation will improve clinical outcomes compared to the staged revascularisation,     guided by prove of ischemia or clinical judgment, as recommended from the guidelines.   "
143987|NCT01399723|"     This study seeks to determine whether clinical outcome following initial treatment of severe     pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin.     The study will also provide an estimate of the proportion of Kenyan children with severe     pneumonia who fail treatment with a single antibiotic.   "
143988|NCT01399710|"     RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is     less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD)     has shown promising results in providing uniform accuracy and improving CT colonography     sensitivity.      PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and     CAD-assisted reading in detecting patients with colorectal lesions.   "
143989|NCT01399697|"     This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of     RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra     monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate.     All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus     oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be     randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either     methotrexate or placebo. Anticipated time on study treatment is 28 weeks.   "
143990|NCT01399684|"     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed     to estimate the efficacy of MEGF0444A treatment to disease progression, combined with     oxaliplatin + folinic acid + 5-Fluorouracil (mFOLFOX-6) + bevacizumab therapy in participants     with metastatic colorectal cancer (CRC).   "
143991|NCT01399671|"     Major depression is characterized by vestibular anomalies. The investigators hypothesized     that vestibular stimulation will improve depression symptoms in major depression patients.   "
143992|NCT01399658|"     Standard therapy for gynecologic cancers involves the use of brachytherapy, also called     internal radiation therapy or implant radiation. The treatment being studied consists of     standard brachytherapy with the additional use of MRI to guide the insertion of radioactive     applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is     practical and beneficial when compared to the standard CT-guided brachytherapy placement. The     investigators are hoping that this MRI procedure will decrease the risk of giving too high a     radiation dose to the bladder or bowel.   "
143993|NCT01399645|"     This study is conducted to test the hypothesis that in type 2 diabetic adults with fatty     liver who are resistant to metformin, treatment with liraglutide in combination with     metformin will cause an absolute reduction in liver fat superior to insulin-metformin     treatment within a 3-month period, as measured by magnetic resonance imaging (MRI).   "
143994|NCT01399632|"     Generally, people with low levels of high-density lipoprotein (HDL) in blood are more likely     to get heart disease than those who have normal or high levels. Dietary fat, whether the     harmful type (saturated) or beneficial type (unsaturated) raises HDL levels. Dietary     carbohydrate lowers HDL. The investigators are doing this research study to find out why the     amount of HDL in a person's blood is affected by dietary unsaturated fat and carbohydrate.     The investigators will trace the ability of the HDL in a person's blood to take up     cholesterol, get bigger, and then leave the blood by passing into the liver. The     investigators want to know if dietary unsaturated fat improves the ability of HDL to do this     compared to dietary carbohydrate.   "
143995|NCT01399619|"     the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or     24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation     of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue     PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or     relapsers patients coinfected with HIV   "
143996|NCT01399606|"     This is a multicentric International Phase III,Long term open label study(12 months)assessing     the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive     Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.   "
143997|NCT01399593|"     The purpose of this trial was to determine the safety and efficacy of eculizumab in the     prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor     kidney transplant requiring desensitization therapy.   "
143998|NCT01399580|"     Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter Study.     The study objectives are to evaluate efficacy and safety, including thoracic bioimpedance, of     once daily administration of atrasentan tablets (high dose and low dose) compared to placebo     in type 2 diabetic subjects with nephropathy who are receiving the maximum tolerated labeled     daily dose of a RAS inhibitor.   "
144019|NCT01399307|"     Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large     therapeutic potential for many rare and common diseases that impacts millions of patients     worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to     extract with minimally invasive procedures such as elective liposuction in large quantities     and therefore may be a cost effective source for cellular therapies in a wide range of     medical specialties. In this study we aim to demonstrate the efficacy of Antria Cell     Preparation Process© in obtaining human adipose derived Stromal Vascular Fraction (SVF) by     performing histology, various cell counts, multiple surface marker tests and measurement of     the residual amount of digestive enzymes as a safety measure for human clinical trials.   "
143999|NCT01399567|"     Pain assessment and management deficiencies in nursing homes (NHs) are well documented.     Unrelieved pain in this setting results in poorer resident outcomes, including depression,     decreased mobility, sleep disturbance, and impaired physical and social functioning. This     randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled     with intense diffusion strategies in improving pain, physical function and depression among     NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain     management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain     education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression     among NH residents; 2) Determine the extent to which adherence to the ALG and organizational     factors are associated with changes in resident outcomes and the extent to which changes in     these variables are associated with changes in outcomes; 3) Evaluate the persistence of     changes in process and outcome variables at long-term follow-up and 4) Evaluate the     relationships among behavioral problems and pain in severely cognitively impaired residents     who are unable to provide self-report.   "
144000|NCT01399554|"     Alcohol use disorders are common and few individuals with the disorder ever seek help. This     study proposes to intervene in a novel way - exercise, as it has many mental and physical     health benefits and is an activity that is incompatible with simultaneous alcohol use. If     effective, this non-stigmatizing intervention may increase the utility and acceptability of     interventions for alcohol use disorders and ultimately increase the number of individuals     effectively treated.   "
144001|NCT01399541|"     The specific aims of this translational, interdisciplinary, multi-center, international     research study with 300 Lung cancer patients are to:      Aim 1 Explore how the patients experience the transfer between different locations and     between different levels of care at the same location and how they experienced coming home.      Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and     symptom clusters over time.      Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health     related quality of life and social support.   "
144002|NCT01399528|"     This is an observational study exploring the genetics of lacosamide response. The study will     last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase,     3) genotyping and analysis. Patients initiating lacosamide are recruited and their baseline     seizure frequency is assessed retrospectively. Patients are then monitored for 18 months with     an assessment (via interview and where possible seizure diaries) of seizure frequency and     other treatment related phenotypes every 3 months. The recruitment period will span months     1-12, the observational period will span months 1-30 and analysis of data will be conducted     between months 30-36 (see Figure 2 below). Target sample size is 610.      Primary objective: To determine the clinical relevance of genetic variation in predicting     lacosamide responsive and non-responsive patients.      Secondary objectives: To determine the clinical relevance of genetic variation in predicting:        -  Optimal dose of lacosamide        -  Adverse drug reactions to lacosamide   "
144003|NCT01399515|"     The purpose of this study is to evaluate the efficacy and safety of oral valproic acid to     slow the progression of visual function and/or to improve the visual function in patients     with retinitis pigmentosa (RP).      Enrolled subjects in valproic acid group will be treated with oral valproic acid 500mg daily     for 48 weeks. Visual function and safety will be assess before and after treatment (48 weeks)     between valproic acid and control groups.   "
144004|NCT01399502|"     The purpose of this study is to investigate the effectiveness of health promotion emails for     depression. It is hypothesised that emails containing self-help advice will improve     depression symptoms more than emails containing information about depression.   "
144005|NCT01399489|"     The current study is designed to examine the impact of 16 weeks of moderate intensity aerobic     training on arterial stiffness and blood pressure in stage 3 chronic kidney disease (CKD)     patients. The investigators hypothesize that short term aerobic training will improve the     stiffness of arteries in CKD patients.   "
144006|NCT01399476|"     This is a study of the safety and efficacy of a new surgical procedure using endoscopic     instruments and a tunneling technique to reach the LES for dissection. We hypothesize that     this technique provides an incisionless, less invasive option with similar functional outcome     compared to standard Heller myotomy.   "
144007|NCT01399463|"     The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting     Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel     disease and side branches by pressure wire guided percutaneous coronary intervention.   "
144008|NCT01399450|"     The purpose of this study is changing (improving), after initiating various doses of     Paliperidone ER on schizophrenia patients.   "
144009|NCT01399437|"     Background:      - A special brain circuit is important for helping us keeping an eye open for things that are     going on around us, even when we are not directly paying attention to them. This circuit     seems to work differently in people with schizophrenia than in other people, which may     explain specific deficits with broad monitoring observed in people with schizophrenia.     Researchers want to compare brain function in people with schizophrenia and healthy     volunteers to find out more about how these brain circuits work and affect attention.      Objectives:      - To study how the brain performs broad visual monitoring in people with schizophrenia.      Eligibility:        -  Individuals between 18 to 55 years of age who have been diagnosed with schizophrenia.        -  Healthy volunteers between 18 and 55.      Design:        -  Participants will be screened with physical and psychological exams. They will have a          medical history. Tests for drug and alcohol use will also be done.        -  Participants will have two study visits. The first is a training visit and the second is          a scanning visit.        -  At the training visit, participants will practice computer-based tests of focus, memory,          and concentration. They will also answer questions about mood, psychiatric symptoms, and          smoking habits.        -  At the scanning visit, participants will perform the computer-based tasks that they          practiced at the training visit. They will have magnetic resonance imaging while they          perform these tasks.   "
144010|NCT01399424|"     The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a     saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide     component consists of an average of 3.5 repeat units of the O-SP plus the core region of the     LPS (O-SPC). The O-SPC is covalently bound to the non-toxic recombinant diphtheria toxin     mutant (rDT).      The objective of this phase of the study is to determine if this vaccine is safe and can     induce IgG antibody type-specific immunity to shigellosis in adults. The overall objective is     to determine if this vaccine can elicit higher levels of IgG antibody than the previous     experimental vaccines made with the full length O-SP, shown to be > 70% efficacious in     greater than or equal to 3 year old children. Higher levels of IgG anti O-SP are expected to     induce type specific immunity to shigellosis in younger children.      Sixty 18-49 years-old healthy adults will be recruited in Israel. Volunteers will be     vaccinated on a random basis with one i.m. injection of 10 or 25 ug of the investigational     conjugate vaccine. Local and systemic reactions will be observed at 30 minutes, and the     volunteers will be instructed to take their temperature and examine the injection site for     redness and swelling and fill out a questionnaire at 6, hours and daily for 7 days after     vaccination. The volunteers will visit the clinic at 24 or 48 hours following the injection     and any time they request it. The study will commence with 5 volunteers injected with the     10ug dose to be followed, if no severe adverse reactions occur, by 5 volunteers injected with     the 25ug dose. If a severe adverse reaction occurs on 1 of the 5 volunteers in either group,     5 more will be injected with that dose. If there are no severe adverse reactions the study     will proceed. If there is one more severe reaction the study will be halted and re-evaluated     by the IRB and the FDA.      Vaccine-induced antibodies will be measured at 1 and 6 months after immunization, and     compared to those elicited by our previous S. sonnei conjugate vaccines.      There is a body of evidence that a critical level of serum IgG antibody to the O-specific     polysaccharide domain of LPS confers type-specific immunity to S. sonnei as well as to other     Shigella:        1. Shigellosis is rarely observed in infants up to the age of 4-6 months. The most obvious          explanation for this is that maternally-derived serum IgG provides this immunity;        2. There is an age-related development of IgG anti-LPS antibodies that, in many instances,          is not induced by the homologous bacteria but by non-pathogenic cross-reacting enteric          bacteria;        3. The highest incidence, morbidity, and mortality occur during 6 months to 6 years of age          when the maternally-derived serum anti-O-SP has waned and the naturally-derived          antibodies have not yet appeared;        4. One injection of a S. sonnei-rEPA conjugate showed significant protection against          shigellosis in Israeli Defense Force soldiers. Vaccinees who developed shigellosis          showed significantly lower serum IgG responses to the homologous LPS than those did          not.The high antibody level induced by the conjugate vaccine indicates the positive          correlation between the serum IgG anti-LPS levels and immunity to S. sonnei infection;        5. Following Phase 1 and Phase 2 studies that showed safety and age-related immunogenicity,          a double-blinded randomized and vaccine-controlled Phase 3 evaluation of S. sonnei and          S. flexneri type 2a O-specific polysaccharide (O-SP) protein conjugates was conducted          among 1-4 year-olds in Israel.      For recipients of the S. sonnei conjugate 71.1% efficacy was shown among 3-4 year-old     recipients, no efficacy was shown for recipients of S. flexneri 2a. There was no     statistically significant efficacy for either vaccine in the 1-3 year-olds. Levels of serum     IgG anti-O-SP were elevated according to the vaccine the children received but G.M. levels     declined rapidly several months after the last injection. Our interpretation is that the     age-related efficacy of the Shigella conjugates was due to the conjugate-induced O-SP     antibody levels. Accordingly, we have developed a method to increase the immunogenicity of     the conjugates to approach the antibody levels of Israeli soldiers shown to be protected by     our S. sonnei O-SP.      Low-molecular-mass O-SP-core (O-SPC) fragments were isolated from S. sonnei LPS, and bound by     their reducing ends to the carrier protein. The O-SPC conjugates used oxime linkages between     the terminal Kdo residues at the reducing ends of the S. sonnei saccharides and aminooxy     linkers bound to the carrier. The coupling reaction was carried out at a neutral pH and room     temperature. The carrier protein was a non-toxic recombinant diphtheria toxin mutant. IgG     antibody levels induced in young outbred mice by this new S. sonnei O-SPC conjugate were     significantly higher then those elicited by the O-SP conjugates.   "
144066|NCT01398683|"     Comparison of epidural anesthesia and general anesthesia for laparoscopic cholecystectomy,     patients in the surgery and the effectiveness of anesthesia after surgery, the incidence of     side effects or complications, and postoperative recovery of the body of the differences   "
144011|NCT01399411|"     Background:      - The Agricultural Health Study (AHS) is looking at the long-term health effects of farming     exposures including pesticides, crops, and animals. The chronic health effects of exposure to     pesticides are easier to study in farmers and their spouses. They know what chemicals they     use and tend to live in the same place for most of their adult lives. AHS participants are     expected to report any changes in their health. This includes any new medical conditions.     Researchers want to follow up on these reports to confirm their accuracy.      Objectives:      - To follow up AHS participants who have self-reported that they have a new disease and     confirm their diagnosis.      Eligibility:      - Current AHS participants.      Design:        -  Researchers will confirm self-reported changes in medical conditions by contacting the          AHS participant to ask for more information.        -  The AHS participant will give permission for researchers to contact their doctor to look          at their medical records. They will also be asked to provide a cheek swab or saliva          sample.        -  Diseases of interest are rheumatoid arthritis, lupus, and Sjogren s Syndrome. Other          diseases will be followed up in the future. Other diseases will be followed up in the          future.   "
144012|NCT01399398|"     Background:      - The cannabinoid type 1 (CB1) receptor is a protein found on some brain cells. It may play a     role in obesity or some psychiatric disorders such as schizophrenia. Imaging studies like     positron emission tomography (PET) can show where CB1 receptors are located. A new     radioactive chemical, 11C-SD5024, may be able to show these receptors more clearly than     previous radioactive chemicals. Better images of CB1 receptors in the brain may help improve     our understanding of obesity and psychiatric disorders. This information may lead to better     treatments.      Objectives:      - To test how well a new radioactive chemical, 11C-SD5024, is taken up by the brain during     imaging studies.      Eligibility:      - Healthy volunteers between 18 and 50 years of age who are able to have positron emission     tomography scans.      Design:        -  All participants will be screened with a physical exam, medical history, and blood          tests.        -  Participants will be in one of three groups for the study. Each group will receive          11C-SD5024 and have a different set of imaging studies.        -  Group 1 will have a magnetic resonance imaging (MRI) scan and PET scan of the brain.          They will also have blood and urine tests.        -  Group 2 will have a whole-body PET scan, as well as blood and urine tests.        -  Group 3 will have an MRI scan of the brain, followed by two PET scans of the brain. They          will also have blood and urine tests. The two PET scans can happen on the same day or on          two different days.   "
144013|NCT01399385|"     Background:      - Imaging tests, such as magnetic resonance imaging (MRI), can provide information about     heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing     and vessel wall thickness. This information may help diagnose and treat heart disease and     other conditions that lead to heart attacks. Better MRI methods are needed to improve heart     disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new     techniques to improve the quality of heart MRI, compared with more complex studies like     catheterization or angiography.      Objectives:      - To compare heart MRI techniques with other tests used to diagnose heart disease.      Eligibility:      - People at least 18 years of age who either have or may have heart disease, or are healthy     volunteers.      Design:        -  Participants will be screened with a physical exam, medical history, and blood tests.        -  They will have an angiography to study the inside of blood vessels. This test is an          x-ray study of the blood vessels. It will be done either separately or as part of a set          of tests to diagnose possible heart disease.        -  Participants will have at least one and up to five MRI scans. The scans will involve          different methods of studying the heart and blood vessels. Participants may also have a          computed tomography scan to confirm the findings of an MRI scan.        -  No treatment will be provided as part of this protocol.   "
144014|NCT01399372|"     RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different     ways. Some find cancer cells and help kill them or carry cancer-killing substances to them.     Others interfere with the ability of cancer cells to grow and spread. Drugs used in     chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the     cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill     cancer cells. It is not yet know whether rituximab and combination chemotherapy are more     effective when given with or without radiation therapy in treating patients with primary     central nervous system lymphoma.      PURPOSE: This randomized phase II trial studies how well giving rituximab and combination     chemotherapy with or without radiation therapy works in treating patients with primary     central nervous system lymphoma.   "
144015|NCT01399359|"     RATIONALE: Learning about how patients make decisions about using chemoprevention may help     doctors plan treatment in which more patients are willing to choose chemoprevention to reduce     their breast cancer risk.      PURPOSE: This clinical trial studies factors influencing decision-making about the use of     chemoprevention in women at increased risk for breast cancer.   "
144016|NCT01399346|"     Rationale: For the development of a closed loop system, faster insulin absorption after bolus     administration could help to reduce the system's delay and thus increase patient safety. It     has been shown that regular insulin absorption is faster when injecting insulin with a     sprinkler needle (containing holes in the walls and being sealed at the tip). The current     study will evaluate the impact of different application volumes on pharmacokinetic and     pharmacodynamic properties of rapid acting insulin analogue (insulin aspart).      Objective: To compare the pharmacokinetic response (based on the time to maximum observed     serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart     after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in     patients with type 1 diabetes.      Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study.      Population: Twelve type 1 diabetic subjects      Intervention: The investigational treatment is the subcutaneous administration of insulin     aspart either as one bolus of 18 IU at one injection site or as 9 separately and     simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma     samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an     8-hour clamp experiment. Patients will undergo both investigational treatments in a     randomized order; between the two clamp visits there will be a wash-out period of 5-21 days.      Main study endpoint: Time to maximum observed serum insulin aspart concentration.   "
144020|NCT01399294|"     Constipation is a common problem in palliative cancer patients. However, there were     insufficient randomized controlled trial (RCT) data to identify the best laxative or     combination of laxatives in these patients.      Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients.     More than half had received at least one form of TCM therapy according to the survey carried     in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging     effects simultaneously may be more preferred to relieve constipation by local palliative     cancer patients.      TCM syndrome differentiated by collecting all symptoms and signs through the classic four     diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.      The present study is the first local study to evaluate the bowel habits and TCM syndrome of     advanced cancer patients with constipation. We hope that the results not only can shed light     on patient's own reporting or experience of constipation and the effectiveness of current     practice, but also can draw up a CHM formulation for advanced cancer patients with     constipation.   "
144021|NCT01399281|"     BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric     rheumatic disease (PRD) and an important cause of short and long-term disability. Although     none of the available drugs for JIA has a curative potential, prognosis has greatly improved     as a result of substantial progress in disease management. The therapeutic treatment of     children with JIA encompasses the use of NSAIDs and intra-articular steroid injections. In     those patients not responding to NSAIDs, methotrexate (MTX) has become the disease modifying     anti-rheumatic drug (DMARD) of first choice worldwide. For children not responding to MTX,     biologic agents recently have become treatment options.      PATIENTS AND METHODS: 3-10 year observation study related to children with JIA undergoing     treatment with MTX or biologic agents with the following objectives:        1. To create a long-term observational registry of a large population of prevalent and          incident cases.        2. Use the accumulating data in the registry to conduct (i) a pharmacovigilance/safety          study (primary endpoint) and (ii) estimate effectiveness (frequency and magnitude of          response, disease activity over time inhibition or slowing of joint erosions and other          radiological evidence of disease progression,), and (iii) estimate adherence to the          various treatment regimens. Data from the registry will be used to compare safety and          effectiveness profiles amongst the patient cohorts.        3. To identify clinical and laboratory predictors of safety, response to therapy, including          remission This project has retrospective (first 3 years) and prospective components (up          to 10 years) and will be conducted by the participating centres of the more than 50          countries belonging to the Paediatric Rheumatology INternational Trials Organisation          (PRINTO certified ISO 9001-2008, www.printo.it), or the Pediatric Rheumatology European          Society (PRES at www.pres.org.uk). The main role of these organisations is to provide a          scientific basis for current treatments of paediatric rheumatic diseases.      The overall hypothesis to be tested is:      • Biologic agents ± MTX agents are able to maintain an acceptable safety profile in the long     term in children with different JIA categories while achieving clinical remission and     prevent/stop joint erosion development over time.      The overall aims are to establish the long term safety of biologic agents and MTX, and their     relative effectiveness in children with JIA who need treatment with second line agents.   "
144022|NCT01399268|"     Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a     major marker of inflammation is known to increase during total joint replacement surgery. IL6     has been found to be elevated postoperatively in patients with hip fractures and has been     linked to mental status changes and possibly other complications. It is known to lead to     shock and participate in the inflammatory state seen in sepsis. High levels have further been     linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress     syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low     dose steroids given in two doses in the initial perioperative period decreased the amount of     IL6 released compared to placebo, but this was not sustained past 24 hours.      Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in     urine samples. It is considered to be a marker of lung injury and is found to be elevated in     patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the     investigators have found that urine desmosine levels rise with bilateral total knee     replacement compared to unilateral total knee replacement indicating possible lung injury.      Therefore the investigators hypothesize:      Continued low dose steroids given three times over a 24 hour period will:        1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement          and maintaining this reduction in IL6 beyond 24 hours.        2. Decrease urinary desmosine levels, and hence be protective of lung injury.   "
144023|NCT01399255|"     The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro     formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic parameter     (PK) and the pharmacodynamic parameter (PD).   "
144024|NCT01399242|"     The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus     corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic®     plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate     (cGFR) from baseline to month 12.      The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute     rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in     patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal     at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus corticosteroids.      Patients will be submitted to monthly GFR determination but, for group comparison, only the     GFR measured at month 12 and month 24 of renal transplantation will be used.   "
144025|NCT01399229|"     This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor®     (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term     pregnant patients.   "
144026|NCT01399216|"     We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll     of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in     subjects with low basal body temperature.   "
144027|NCT01399203|"     To investigate the predictive value of the contrast media volume to creatinine clearance     (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and     to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI   "
144028|NCT01399190|"     This prospective observational study will evaluate the efficacy and safety of bevacizumab in     combination with capecitabine and oxaliplatin as first-line treatment in participants with     colorectal cancer. Data will be collected from each participant until disease progression     occurs (for up to 30 months).   "
144029|NCT01399177|"     The purpose of this study is to find out if there is any change in diet on food cravings and     weight loss in the 12 months following bariatric surgery.   "
144030|NCT01399164|"     To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in     subjects with proton pump inhibitor induced achlorhydria.   "
144033|NCT01399125|"     The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon®     patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory     submission and registration of Exelon transdermal patch in China. The study is designed to     confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus     Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease     Assessment Scale-Cognitive Subscale (ADAS-Cog).   "
144034|NCT01399112|"     The investigators propose to recruit patients who have experienced a recent first episode of     psychosis who have a chart diagnosis of Schizophrenia, Schizophrenifom, Schizoaffective     Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features and self identify     themselves as a current cigarette smoker. Aiding this population with smoking cessation is     crucial as the majority of people with schizophrenia spectrum disorders (50-90%) smoke, which     is leading to early mortality. While these individuals can benefit from standard     evidence-based treatment, these treatments are underutilized. Web based programs, such as the     EDSS and thetruth.com, can provide education and motivational tools to help people with a     recent onset of psychosis use evidence-based smoking cessation treatments. This study aims to     test these two web-based programs among young people with a recent episode of psychosis for     usability and likeability and to explore whether use of these two programs will motivate     users to seek smoking cessation treatment or to engage in other quitting behaviors in the     month following use of the programs. Information gathered from this proposal will be used to     help the researchers decide whether either of these two programs will be reasonable to     include in a larger study of a comprehensive treatment for individuals with first episode     psychosis.   "
144035|NCT01399099|"     Neodyne has developed an investigational dressing for post-operative incision care. Neodyne     is conducting this research to study whether the investigational dressing, called the Neodyne     Dressing, can minimize scar formation in a simple manner.   "
144036|NCT01399086|"     This is a retrospective chart-review study that will be based on the collection of data from     electronical or paper-based medical records with available data on patients who have     commenced treatment with fulvestrant after January 1st of 2007. All necessary information for     the purposes of the present study will be collected with the use of a paper-Case Record Form.   "
144037|NCT01399073|"     Compared to the classical paper and pencil-tests, testing patients in our virtual reality     setup might have a higher sensitivity and specificity.   "
144038|NCT01399060|"     This single-site, within-subject, experimental study is designed to test the hypothesis     children who live in a household in which one or both of their parent smoke will exhibit a     higher cough threshold and will prefer more intense sweet tastes than children who live in a     household where neither parent smokes. Subjects will include at least 50 racially and     ethnically diverse, healthy children aged 10 to 17 years (a critical time for experimenting     with tobacco) and a parent. The sample will comprise two groups: Non-Environmental Tobacco     Smoke (ETS) Exposed (neither the child nor parents has ever smoked or been exposed to     environmental tobacco smoke (ETS) in the home), and ETS-Exposed (the parent has smoked at     least 3 cigarettes per day for at least five years in the home, with the child living in the     home continuously). Cough sensitivity will be measured using a standard single-inhalation     challenge, a test of the minimum concentration of capsaicin (the spicy chemical in hot     peppers) needed to elicit cough. Sweet taste preferences will be measured using a     forced-choice paired comparison method of liquids which differ in sucrose content. Measures     of breath carbon monoxide will validate the smoking status of parents and their adolescent     children. The key comparison will be between Non-ETS Exposed and ETS-Exposed children, with     the difference between smoking and non-smoking parents as a positive control. Because smoking     and non-smoking families may differ in ways besides tobacco exposure, the investigators will     obtain health histories (with a focus on respiratory illness), smoking histories, measures of     body weight, diet, and responses to personality tests (including susceptibility to     addiction). The investigators will also obtain genomic DNA from saliva samples. Genes for     chemosensory receptors that are part of the cough reflex pathway and genotype may account for     aspects of cough sensitivity.   "
144039|NCT01399047|"     The primary objective of this trial is to establish the safety and tolerability of short-term     (8 weeks) administration of mycophenolate mofetil in ambulatory children with JNCL. The     secondary objective is to gather preliminary evidence of the short-term (8 week) impact of     mycophenolate mofetil on clinically relevant features of JNCL as measured by the Unified     Batten Disease Rating Scale (UBDRS), including motor features, seizures, behavior, cognitive     and functional measures.      Funding source-FDA Office of Orphan Product Development (OOPD).   "
144040|NCT01399034|"     The overall goal of this research is (1) to identify changes in gene expression and DNA     methylation status in subjects who exhibit advanced chronic periodontal inflammation and (2)     to identify microRNAs (miRNAs) and the interactive pathways associated with obesity as a     modifier of periodontal infection pathogenesis.   "
144041|NCT01399021|"     There is no standard of care of management following parotidectomies. Most practitioners     however place a drain (usually a flat Davol closed suction drain/ Hemovac in the     investigators institutions) in the wound bed at the end of the procedure, which is usually     removed the day following the surgery, or when the drain output reaches a subjective number     (depending on surgeon preference). The investigators hypothesis is that there is no     difference in hematoma/bleeding or infection rate when post parotidectomy drains are removed     in the recovery area on the day of the surgery prior to discharge, compared to drains that     are kept in place for at least 1 day or until drainage is less than 50 cc/24 hrs. The     investigators would therefore like to undergo a randomized control clinical trial to assess     the rate of significant hematoma formation and infection, the need for readmission and length     of admission secondary to these complications when comparing 2 groups: one where drains are     removed prior to discharge from the recovery area and the other where the patients are     discharged with the drain and seen the next post operative day in the office. The drain     output will then be measured and the drain taken out.   "
144042|NCT01399008|"     The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in     combination with allopurinol compared to allopurinol alone when administered orally once a     day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol     alone.   "
144069|NCT01398644|"     Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in     excessive iron overload. Phlebotomy is currently the standard therapy. More recently     Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially     offers a more efficient method to remove iron overload with fewer procedures.In the proposed     clinical trial the investigators will examine whether TE can keep the ferritin levels in     patients requiring maintenance therapy below 50 microg/L, with minimally half the number of     treatment procedures when compared to current standard therapy by P.   "
144043|NCT01398995|"     People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but     problems with metabolism and blood glucose control can make this difficult. Some people with     T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous     insulin infusion (CSII) therapy, in which a background or basal level of insulin is     constantly infused under the skin by a special pump, with bolus doses of insulin given to     accompany food. Clinical experience suggests that this may be particularly useful for     managing diabetes for exercise, but there is limited experimental evidence to support this.     The aim of this research , which is divided into three parts, is to investigate the     hypothesis that the physiological response to sub-maximal (moderate) exercise of a person     with type 1 diabetes treated with CSII, can be made to approximate more closely to the     physiological response of a healthy individual by a prior reduction of their basal insulin     infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion     rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose     (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have an     immediate effect on levels of insulin in the body, and evidence from adults suggests that the     level of insulin in the bloodstream at the start of exercise is an important factor in     whether hypoglycaemia develops during exercise. This suggests that reducing the basal insulin     infusion rate some time before exercise may be useful. The aim of this study is to compare     the effect of a basal insulin reduction on blood glucose levels between visits when this     reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90     minutes before. The null hypothesis to be tested is that there is no difference between these     conditions.   "
144044|NCT01398982|"     Breast reconstruction using a patient's own abdominal tissue is one of the most common     methods for restoring mastectomy defects for breast cancer patients. Despite its increasing     popularity and safety, the abdomen remains a major source of postoperative pain. Adequate     pain control is important as it has been shown to reduce medical complications, in-hospital     death, shortens hospital stay, lessen chronic pain and disability, and in turn lower     health-care costs. The current postoperative pain relief protocol consists primarily of a     patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause     numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties,     bladder and bowel dysfunction. A promising approach to provide postoperative pain control of     the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral     nerve block. Although the TAP block has been found to be an effective pain-relief following     major abdominal surgeries, its use has never been studied for breast reconstruction using     abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a     TAP block in reducing postoperative abdominal pain following abdominal tissue breast     reconstruction. This study has significant implications in improving both clinical care and     health outcomes in patients undergoing this common method of breast reconstruction technique.   "
144045|NCT01398969|"     The goal of this study is to determine the outcome of patients with recurrent CDI treated     with fresh HBT versus frozen-and-thawed HBT in a randomized controlled trial. The specific     objectives are to evaluate the safety of both types of HBT and to compare the clinical     response, treatment failure and relapse rate in patients treated with fresh HBT compared to     those treated with frozen-and-thawed HBT; also to assess the functional health and well-being     of patients in each arm using a validated tool. The metagenomics will also be conducted from     the stool samples collected from select patients from each arm: pre and post treatment and     the matching donors. The metagenomics data will be used to determine the bacteria which may     have contributed to the cure of CDI.   "
144046|NCT01398956|"     The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are     judged to benefit from continued treatment with Levetiracetam by the investigators and who     are willing to continuously receive this drug.   "
144047|NCT01398943|"     More patients with chronic obstructive pulmonary disease (COPD) die from cardiovascular     disease than direct pulmonary complications. Inflammation and oxidative stress,     characteristic in COPD, are likely contributors to the reduction in nitric oxide (NO)     bioavailability and vascular endothelial dysfunction in COPD patients; however, this has yet     to be determined. Thus, the overall objective of this proposal is to identify the role of NO     bioavailability in contributing to vascular endothelial dysfunction in patients with COPD and     to provide insight into the molecular mechanisms involved. Our central hypothesis is that     inflammation and oxidative stress, both independently, contribute to the reduction in NO     bioavailability and vascular endothelial dysfunction in patients with COPD.   "
144048|NCT01398930|"     The objective of this study is to assess the efficacy of acupuncture as an adjunctive therapy     to pharmacological treatment of chronic pain due to knee osteoarthritis, as well as for, the     improvement of physical functioning, reduction of stiffness, and improvement in quality of     life. This is a 3-armed single-blinded randomized sham-controlled trial, comparing     acupuncture along with pharmacological treatment, sham acupuncture including pharmacological     treatment, and pharmacological treatment alone. One-hundred and twenty patients with knee     osteoarthritis were randomly allocated to 3 groups. Group I was treated with etoricoxib,     Group II was treated with acupuncture and etoricoxib, and Group III was treated with sham     acupuncture and etoricoxib.   "
144049|NCT01398917|"     Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract     of unknown origin. Around 50% of patients develop during their disease course narrowing of     the main bile duct with corresponding increase in symptoms such as itching, jaundice and     abdominal pain. These narrowings can be treated by balloon dilatation or temporary insertion     of a plastic endoprosthesis. However, it is not known which of these two therapeutic     modalities is best. This study aims to compare both techniques in order to determine which is     best in terms of postponing recurrence of the narrowing, safety and costs.   "
144050|NCT01398904|"     Body Dysmorphic Disorder (BDD) participants will demonstrate greater attentional biases as     compared to healthy control (HC) participants. Greater attention bias will be associated with     greater distress. Greater attention bias will be associated with greater symptom severity.   "
144067|NCT01398670|"     This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's     Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and     Humalog® Mix in patients with Type 1 Diabetes Mellitus   "
144068|NCT01398657|"     This is an open-label randomized clinical study comparing primary prostate cryoablation alone     (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy     (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.   "
144083|NCT01398462|"     CWP232291 blocks proliferation of cancer cells via activation of caspases. Active caspase     have been shown to target beta-catenin, the hallmark of canonical Wnt signaling, for     degradation through caspase-directed cleavage. CWP232291 targets beta-catenin for degradation     and thereby inhibits the expression of cell cycle and anti-apoptotic genes such as cyclin D1     and survivin.   "
144051|NCT01398891|"     This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for     suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase     enrollment rates and obtain information for patients with a wide range of diagnoses and     illness severity. Enrolled subjects will complete randomly-selected positive psychology     exercises daily (on weekdays) until discharge and will rate the exercises in multiple     domains. Subjects' participation will be complete at the end of their admission or when all     exercises have been completed, whichever comes first.      Overall, our goal is to assess the acceptability and utility of eight possible positive     psychology interventions related to gratitude, optimism, kindness, mindfulness, recollection,     and forgiveness in suicidal inpatients.      This is a single-arm study, completed with patients who have been admitted to the hospital     for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology     treatment aimed at suicidal patients. The study consists of serial completion of different     positive psychology exercises, once daily, during admission, to get subjects' input on their     feasibility and impact. This will allow us to work collaboratively to identify the specific     exercises that best fit this population. Subjects' participation ends when they are     discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and total)     in this study.   "
144052|NCT01398878|"     The purpose of this study is to determine the impact of eliminating traditional resident work     shifts (i.e. greater than 24 hours in length) on patient safety and resident educational     outcomes. In addition, the investigators will explore with key stakeholders (patients and     their families, nurses, resident physicians and attending physicians) their experiences when     residents are undertaking shifts greater than 24 hours in length as compared to 16 hours or     less.   "
144053|NCT01398865|"     The purpose of this study is to find out more about the brain's response to selective     serotonin reuptake inhibitor (SSRIs) treatment in people with body dysmorphic disorder (BDD).     The investigators will use positron emission tomography (PET) and Magnetic Resonance Imaging     (MRI) scans to look at brain activity in people with BDD before and after treatment with an     SSRI. The investigators hope that what is learned will allow prediction of whether someone     will improve with SSRI treatment.   "
144054|NCT01398852|"     The purpose of this research study is to evaluate the long tern safety and effectiveness of     cross-linking in eyes with keratoconus and ectasia.   "
144055|NCT01398839|"     The purpose of this research study is to test the safety, tolerability, and effectiveness of     corneal collagen cross-linking (CXL) when used to treat ectasia.   "
144056|NCT01398826|"     The purpose of this study is to assess the glycemic response to cycling road races (using     continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic     controls. The investigators will also assess the relationship between power/work during     cycling (using a power meter) and the subject's glucose profile.   "
144057|NCT01398813|"     In this survey of X-Lined Hypohidrotic Ectodermal Dysplasia (XLHED) carrier females, Edimer     proposes to review responses to an XLHED Carrier Outlook toward Reproduction Survey in order     to understand attitudes toward reproduction, potential treatments and genetic testing in     order to improve the understanding of the decisions that XLHED carrier females make regarding     their reproductive future.   "
144058|NCT01398800|"     Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee     Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile     bearings in the revision TKA setting include reduction in polyethylene wear, decreasing     fixation stresses, and protection of the constraining mechanisms. Several studies have     reported satisfactory clinical results after revision total knee arthroplasty but no study     with a large number has specifically addressed the clinical outcomes after revision total     knee arthroplasty using the mobile bearing design   "
144059|NCT01398787|"     The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS     contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK®     COLORBLENDS contact lens wearers.   "
144060|NCT01398774|"     The investigators would like to learn more about the metabolic consequences of     pseudohypoparathyroidism type 1a in children, adolescents and adults with this condition.     People with pseudohypoparathyroidism 1a are at risk for development of obesity. To better     understand the cause of overweight or obesity, investigators are measuring body composition     and resting energy expenditure (REE), which is the amount of calories burned while completely     at rest. The investigators also want to determine the amount of body fat.   "
144061|NCT01398761|"     The purpose of this grant is to fund the research necessary to fully understand the impact of     this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. This     information will inform exactly how Partners will move ahead with tools to improve handoffs     in care (i.e., whether the prototype will be adapted further, adopted Partners wide, or     abandoned in favor of other solutions). The investigators hypothesize that a web-based     handoff tool improves provider satisfaction, the quality of written sign-outs, and measures     of continuity of care compared with current handoff tools.   "
144062|NCT01398748|"     Excessive free radical formation and depletion of the brain's primary antioxidant,     glutathione, are established components of Parkinson's disease (PD) pathophysiology. While     there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some     preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles     surrounding currently employed delivery methods have hindered the clinical utility of this     therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM therapy     in patients with PD, and bypasses the obstacles associated with other delivery methods. It     has been used in clinical practice since 2005. The aim of this study is to evaluate safety,     tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I     single ascending dose escalation study.   "
144063|NCT01398722|"     The investigators sought to determine whether intensive insulin therapy can improve prognosis     of infants undergoing cardiac surgery.   "
144064|NCT01398709|"     The purpose of this study is to investigate the relationship between rewarming rate during     cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.   "
144065|NCT01398696|"     To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in     primary care.   "
144070|NCT01398631|"     Various elements of patient history are checked and entered in the admission Case Recor Form     (CRF). Three risk scores are calculated out of these elements, combined with physical     examination, laboratory values and ECG-findings.      The primary aim is to assess the positive and negative predictive values for a cardiovascular     event of the three risk scores for chest pain patients.      Secondary aim is to assess the sensitivity and specificity of various elements in the patient     history for an acute coronary syndrome.   "
144071|NCT01398618|"     Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in     recent years. Further reduction in TB incidence, or even elimination should rely on treatment     for LTBI. However, which is the cost-effective screening method or what is the cost-effective     regimen in Taiwan is still unclear.      Therefore, the investigators designed this prospective study to follow up adult household     contacts with LTBI for 2 years and compare the efficacy of 9-month isoniazid and 4-month     rifampicin).   "
144072|NCT01398605|"     The study is designed to investigate the physical activity and its dose-response relationship     in postmenopausal women on the cardiovascular risks and cardiac function.   "
144073|NCT01398592|"     This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG)     lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a     two weeks treatment on top of metformin.   "
144074|NCT01398579|"     The investigators hypothesis that        1. clinical applicability and overall diagnostic sensitivity and specificity of pCLE for          diagnosing gastric preneoplastic and neoplastic lesions is acceptable        2. pCLE, as compared to white-light endoscopy (WLE), AFI and magnifying NBI has higher          sensitivity and specificity for the diagnosing gastric pre-neoplastic and neoplastic          lesions   "
144075|NCT01398566|"     Today's hospitals need innovative solutions to help patients transition from our care to     self-management at home. The vast majority of the patients seen in Dodd Rehabilitation     Hospital and associated clinics leave our care with persistent and life-altering challenges -     behavioral, cognitive, emotional and/or physical. The period of time immediately following     discharge is an under-addressed stage within the continuum of care. The investigators are     researching solutions to help patients in this transition to self-care and believe that     multiplayer gaming paradigms may be a promising innovation to facilitate this transition.      The investigators believe that Dr. Jane McGonigal's SuperBetter, and positive play games like     it, are promising novel interventions that could make a positive difference in the ability of     our patients to successfully transition to self care after discharge from therapeutic care.      Specifically, the investigators will evaluate feasibility of use of such a game by mild to     moderate brain injured individuals and to record pilot data to help us plan a clinical     effectiveness follow up study. Our goal is to finish this study with an intervention tailored     for use within the clinical continuum of care and sufficient pilot data to prepare for a     randomized clinical control trial of this intervention.   "
144076|NCT01398553|"     The Armeo Spring has proven its effectiveness in the rehabilitation of acute stroke patients.     It neutralizes limb weight, enabling patients to use residual control in both arm and hand     and to follow exercises guided by simulations of real-life challenges. The Armeo Spring     incorporates wrist pronation and supination, allowing patients to enhance functional reaching     patterns.      Aim of the study is to compare the Armeo device with standard physiotherapy in chronic     patients with acquired brain lesions.      The result of the trial should show which treatment is more effective in the clinical     practice. A significant better outcome of one arm should suggest to follow one treatment     strategy more than the other.   "
144077|NCT01398540|"     The aim of this project is to investigate humoral and cellular immune responses before and     after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 65 years     of age.   "
144078|NCT01398527|"     The research question is, does a multifaceted, multidisciplinary intervention including small     groups, chart audits and point of care tools, increase the number of people receiving optimal     vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number     of falls and fractures experienced by the residents in each LTC home and the number of     residents receiving appropriate bisphosphonate therapy.   "
144079|NCT01398514|"     The purpose of the study is to learn how differences in learning under mildly-stressful     circumstances may be changed by taking an antidepressant medication. This medication is     called Lexapro (Escitalopram). The investigators will also examine the impact of any anxiety,     depression, and stress related symptoms on learning processes. The investigators will also     look at the response of these symptoms to Lexapro.   "
144080|NCT01398501|"     Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for     patients with AML with the FLT3-ITD mutation and information from these studies suggests that     sorafenib may help to control leukemia. The purpose of this study is to find the highest dose     of sorafenib for maintenance therapy that can be safely used in participants with AML who     have undergone allogeneic stem cell transplant.   "
144081|NCT01398488|"     Experimental intervention:      Patient education after lung transplantation via Tablet computers. An electronic patient     questionnaire via tablet computer will be collected in addition.      Control intervention:      Conventional Patient education by health care professionals. A paper-based patient     questionnaire will be provided.   "
144082|NCT01398475|"     The purpose of this trial is to assess the effect of 3 formulations on the relative     bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4     separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK)     samples will be collected during each treatment period. Approximately 5 to 7 days of washout     period between each treatment and a follow-up visit will occur approximately 5 to 7 days     after the last dose of study drug.   "
144095|NCT01398306|"     The primary objective of this study is to analyse the concentration dopamine and serotonin in     thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to     the concentrations of these catecholamines in healthy volunteers. The concentration dopamine     and serotonin in thrombocytes with and without medication will also be evaluated.   "
144525|NCT01392703|"     The purpose of the study is to compare the blood levels of dasatinib in healthy participants     who received tablet formulation with those of healthy participants who received liquid and     tablet-dispersed formulations of the drug.   "
144085|NCT01398436|"     The aim of the study is to compare oxygen saturation of blood samples collected from the     superior vena cava, the right atrium, and the pulmonary artery. A secondary target was to     assess whether positioning the tip of central venous catheters in the right atrium causes     more arrhythmias than positioning it in the superior vena cava.      The study is carried out in patients that undergo central venous and pulmonary artery     catheterization for surgical coronary revascularization. In the interventional group (atrium,     A), the tip of the central venous catheter (CVC) is placed in the right atrium; in the     control group (control, C), the tip is placed in the superior vena cava. In both groups, CVC     position is confirmed with transesophageal echocardiography (TEE). At fixed times during     surgery and in the following 72 hours, heparinized blood samples are collected from the     proximal and distal CVC lumens and from the distal lumen of the pulmonary catheter (PC) and     oxygen saturation is measured by an oximeter. Besides, mechanical and electrical     complications potentially influenced by CVC position are registered.        1. The primary aim of the study will be achieved by performing the following analysis on          values from CVC proximal and distal lumens:             1. a Bland Altman analysis between proximal and distal oxygen saturation in group A,               in order to evaluate if the two measures are equivalent             2. a comparison of the difference between proximal and distal oxygen saturation in               groups A and C in order to rule out random errors        2. In addition:             1. differences in oxygen saturation between proximal or distal CVC and distal PC will               be compared in order to evaluate whether distal saturation is more indicative of               mixed venous saturation             2. differences between proximal and distal oxygen saturation will be correlated with               cardiac index and PCWP to investigate if low cardiac output and hypovolemia               increase differences        3. The secondary aim of the study will be achieved by comparing the incidence of cardiac          arrhythmias in groups A and C   "
144086|NCT01398423|"     A randomized, double-blind, active control trial to determine the safety, efficacy and     pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with     hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.   "
144087|NCT01398410|"     The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10     mg tablets administered once daily in participants who were confirmed to have no recurrence     of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in     the E3810-J081-308 (NCI01397448) [Double-Blind Phase] study. From a total of 420 participants     who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.   "
144088|NCT01398397|"     This study is being done to collect information about people who have or may have     Hypohidrotic Ectodermal Dysplasia (HED) or X-linked Hypohidrotic Ectodermal Dysplasia     (XLHED). This study will allow Edimer Pharmaceuticals to know more about HED/XLHED so that     hopefully the investigators can develop a drug to treat this condition. In this study Edimer     will retrospectively review and abstract (summarize) medical records of people that have or     may have HED/XLHED in order to further understand the natural history and disease     characteristics.   "
144089|NCT01398384|"     The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on     Myocardial Infarction Size.   "
144090|NCT01398371|"     Heart failure is a chronic condition in which the heart fails to function as a pump to move     blood around the body. This sets up a complex physiologic response to compensate, which     include activation of many hormonal mechanisms which result in fluid accumulation.      In recent years, medications to block the hormonal response to heart failure are given as     standard drugs, and these include ACE inhibitors, and beta blockers. Mortality is reduced     with these medications, as well as symptoms improved.      Medications that were traditionally used in heart failure include diuretics, which cause     fluid loss, and digoxin, which causes the heart to pump harder. These medications were     introduced before clinical trials as we know them now were run. Since the introduction of ACE     inhibitors and beta blockers, it is not clear whether there is still a role for digoxin.      In this study, we plan to withdraw digoxin from patients with stable heart failure in normal     rhythm, taking stable doses of ACE inhibitors and beta blockers, in a closely monitored     environment and watch for the effect of this on heart failure.   "
144091|NCT01398358|"     The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area     is to reduce the prevalence of obesity among children attending Head Start in Michigan. The     proposed intervention program is based on Social Cognitive theory and the premise that     enhancing children's capacity for emotional and behavioral self-regulation is a key component     of effective obesity prevention. A randomized controlled trial design is proposed to     evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches     to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum     delivered to preschoolers and their parents focused on obesity-related health behaviors; and     (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program     designed to improve preschoolers' emotional and behavioral self-regulation. The research     objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure,     will lead to greater improvements in obesity-related health behaviors and adiposity indices;     and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors     and adiposity indices, and this effect will be mediated by improved self-regulation. The     extension objective is to evaluate the feasibility, fidelity, and educational effectiveness     of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators     within Extension and Head Start. The education objective is to provide Extension and Head     Start staff non-formal training and educational curricula which can be widely disseminated.     The long-term goal of this project is disseminate a novel and effective approach to obesity     prevention in preschoolers.   "
144092|NCT01398345|"     Background      —Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality     of life, and a poor prognosis because of right heart failure. The present study is the first     prospective randomized study to evaluate the effects of exercise and respiratory training in     patients with severe symptomatic PH.      Methods      —Patients with PH on stable disease-targeted medication will be randomly assigned to a     control and a primary training group. Medication will remain unchanged during the study     period. Primary end points will be the changes from baseline to week 15 in the distance     walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life     questionnaire. Changes in WHO functional class, Borg scale, and parameters of     echocardiography and gas exchange also will be assessed.      Prospects      —We hope this study will indicate that respiratory and physical training are a promising     adjunct to medical treatment in severe PH.   "
144093|NCT01398332|"     This is an observational Registry designed to obtain early data on the use of the GORE®     EXCLUDER® AAA Endoprosthesis with C3 Delivery System.   "
144094|NCT01398319|"     The prevalence of alcohol related incidents in technical training is too high. A brief group     alcohol intervention was designed to reduce the number of alcohol related incidents in     Technical Training.      Hypotheses or Research Questions:      Can a brief group alcohol intervention, focused on responsible use of alcohol during     technical training reduce the prevalence of alcohol related incidents?   "
144096|NCT01398293|"     This single-dose, randomized, double-blind, double-dummy, placebo-controlled,     positive-controlled four-way crossover study will evaluate the effect of a single dose of     danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects     will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of     danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D:     placebo, with a washout period of at least 7 days between treatments.   "
144097|NCT01398280|"     The purpose of this study is to determine the effect of topical aminocaproic acid on the     immune system by assessing the levels of antimicrobial peptides in the skin of patients with     rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's     immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.   "
144098|NCT01398267|"     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the     effect of aleglitazar on renal function, the renin-angiotensin system and the     pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with     lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be     randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to     lisinopril for 4 weeks.   "
144099|NCT01398254|"     Primary percutaneous coronary intervention (PPCI) has become the dominant strategy for the     treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is     superior to fibrinolytic therapy. Recent evidence suggests that transradial access (TRA) is     superior to transfemoral (TFA) for patients undergoing PPCI. Two large trials report a     mortality benefit favouring TRA. The results of these two trials could significantly impact     practice guidelines and lead to a recommendation that the approach of choice for primary PCI     be radial rather than femoral. This would have significant implications for both PCI centers     and interventionalists associated with a large impact on practice and education. Yet, many     centers and interventionalists in Canada and in the USA prefer TFA and currently feel     pressured in making the change to TRA. With that said, these trials did not include new     pharmacotherapy and new technology that would likely have closed or eliminated the gap     between TFA and TRA by improving the safety and efficacy of these two approaches.     Furthermore, these trials were not powered to conclusively show a mortality benefit. The     authors of the two large trials emphasized the need for further trials to confirm the     benefits of TRA.      The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary     percutaneous intervention (PPCI). The primary outcome will be defined as all cause mortality     measured at 30 days. The trial will also evaluate: 1) bleeding events and 2) the composite of     death, reinfarction, or stroke defined as major adverse clinical events (MACE). The trial     will include the use of antithrombotic therapy with monotherapy, with either bivalirudin or     unfractionated heparin; the use of glycoprotein inhibitors IIb/IIIa inhibitors will be     avoided. The study will encourage liberal use of vascular closing devices. The trial will     also compare delays to reperfusion between the two strategies. Finally, a cost analysis is     proposed.      In view of recent publications, there is now a need for a large randomized trial using     contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in     PPCI. The proposed trial aims to conclusively show whether there is a survival benefit     associated with the TRA approach.   "
144100|NCT01398241|"     This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate     the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in     healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally     daily for 28 days. Follow-up will be 10 weeks after the last dose.   "
144101|NCT01398228|"     The burden of chronic, non-communicable disease, of which cardiovascular disease comprises a     significant component, has increased rapidly and substantially in China over recent years.     Over the coming decades China is predicted to experience a 69% increase in acute coronary     disease(ACS), amounting to nearly 8 million additional events. A recent randomized trial of     more than 15,000 patients with acute coronary syndromes, the second phase of Clinical Pathway     for acute coronary syndromes in China (CPACS-2) study, showed that a quality improvement     initiative could improve aspects of hospital care, including the proportion of patients     discharged on appropriate medication. The study also identified a number of barriers to     improved care including out of pocket costs and administration systems. However, the study     was not able to determine the impact on clinical outcomes or the cost-effectiveness of the     intervention. The aim of the third phase of the Clinical Pathway for acute coronary syndromes     in China (CPACS-3) study is to determine whether a complex intervention comprising a clinical     pathway for ACS management in combination with a number of physician and patient-oriented     education tools can improve the quality of care and health outcomes among ACS patient     admitted to resource-limited (provincial) hospitals. The effectiveness of the intervention     will be evaluated using a cluster randomized trial (stepped wedge design) of ACS patients     admitted to 104 hospitals in China. The study will incorporate two additional components (1)     a qualitative substudy to identify the barriers and enablers to improved care and (2) a study     comparing the cost-effectiveness of the intervention compared to usual care, from the     perspective of the health care provider. The study will be conducted in conjunction with the     Chinese Ministry of Health and the Chinese Society of Cardiology. The findings from CPACS3     will be able to inform health policy-makers about the extent to which quality improvement     initiatives can reduce the risk of death and disability among the millions of ACS patients     admitted to hospitals in China each year.   "
144102|NCT01398215|"     This is a prospective chart review/data collection study of natural orifice translumenal     endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires     administered throughout the study. Subjects enrolled will be those intending to have a     transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12     months post-op.   "
144103|NCT01398202|"     The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is     five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared     to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week     supplementation study during winter months.   "
144104|NCT01398189|"     To examine the feasibility of molecular imaging markers in clinical psychopharmacology   "
144105|NCT01398176|"     The purpose of this study is to determine whether consuming mushrooms is effective in     enhancing the function of γδ T cells.   "
144106|NCT01398163|"     The purpose of this study is to evaluate the effect of a commercially available fermented     dairy product containing probiotics (4 weeks, twice a day) on the brain activity within     specific neural circuits regulating the subjective experience of emotional valence and     digestive well-being.   "
144107|NCT01398150|"     The purpose of this study is to determine whether consuming a beverage made with cranberry     polyphenols and proanthocyanidins is effective in modifying immune function by enhancing     immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell     proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.   "
144108|NCT01398137|"     This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue     medication usage (as measured by Rescue Medication Score as a Combined Score to inform the     design of a phase III field study with ToleroMune Ragweed.   "
144337|NCT01395147|"     The purpose of this study is to assess the safety and efficacy of Lu AA21004 in participants     with major depressive disorder after completion of an 8-week double-blind treatment period in     a preceding study (Lu AA21004/CCT-003; NCT01355081).   "
144204|NCT01396889|"     Acute upper respiratory tract infections are the most commmon infections in children and are     associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea     is widely used for treatment of upper respiratoty tract infections. The aim of this study is     to evaluate its efficacy as prophilaxis in children 1-5 years old.   "
144109|NCT01398124|"     Despite recent advances in the treatment of patients with resected NSCLC, disease recurrence     and mortality related to lung cancer are common among patients with early stage non-small     cell lung cancer (NSCLC). Therefore novel approaches are necessary to improve the outcome for     early stage NSCLC. The preclinical studies conducted with vaccine based approaches provide     the rationale to evaluate this as an adjunct to surgery for patients with early stage NSCLC.     Administration of the vaccine before surgery will also allow for the evaluation of the tumor     specimen for immunological responses to the vaccine.   "
144110|NCT01398111|"     This study will be carried out in healthy volunteers with the primary objective to evaluate     the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised     metered dose inhaler (pMDI).   "
144111|NCT01398098|"     Ultra-sound study to assess changes in intragastric volume after bowel preparation.   "
144112|NCT01398085|"     IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine ablation     is necessary for low risk differentiated thyroid cancer patients.   "
144113|NCT01398072|"     Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and     exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK.     Bacterial infections play an important role in the development of COPD, however, there is     little information available about the use of long term antibiotics in the treatment of this     disease. Therefore the purpose of this study is to identify the best antibiotic regime for     treating patients with COPD who have persistent bacterial infection in their lung. We will     test a variety of approaches including both older and newer regimes prescribed either on a     daily basis at a lower dose or in pulsed courses (for example, every other day or five days     every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and     doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is     expected that approximately 200 patients will be selected for this study. The information we     get from this study may help us to treat future patients with COPD better.   "
144114|NCT01398059|"     The purpose of this study is to determine whether acute bouts of sedentary behaviour (with or     without breaks and/or structured physical activity) result in measurable changes in metabolic     health in children and youth.   "
144115|NCT01398046|"     The goal of this study is to evaluate the ability of a natural supplement (betaine     hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators     predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers     pre-treated with proton-pump inhibitors (PPIs).   "
144116|NCT01398033|"     There is both a poor life expectancy and a poor prognosis of limb salvage in those patience     with stenoses or occlusions of the lower limb. To date only a small number of these patients     could be helped through medication or surgery. The indications for stent placement are poor     primary results following percutaneous transluminal angioplasty or evidence of a     flow-limiting dissection. The primary success rate after a stent placement is between 80% and     90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which     is expected in 20% to 78% of treated lesions, depending on the stent used. Using only     percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis     reoccurs in 70% to 80% of cases.      The aim of this study is to analyse the primary success and the long term results of     angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in     the treatment of in-stent restenosis of lower limb arteries.   "
144117|NCT01398020|"     The investigators wish to compare the efficacy and patient tolerability of a preparation     consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte.     The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher     efficacy and tolerability.   "
144118|NCT01398007|"     Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as     well as future behavior related to dental problems in children. A common cause of such     anxiety and fear is the procedural intervention that uses needles and syringes since a visual     impact due to the needle acts as a deterrent to the child's cooperation during dental     procedures. We therefore improvised the syringe such that it will camouflage the needle. We     hypothesized that the use of this needle will alleviate the child's anxiety and therefore     will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group     randomized trial to test the efficacy of the camouflage syringe as compared to the     conventional syringe in children.   "
144119|NCT01397994|"     This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener,     nicorandil in patients of chronic stable angina.   "
144120|NCT01397981|"     The purpose of this study is to determine how well people can be trained to produce new and     different movements through the use of haptic feedback. One particular application is     retraining individuals to walk differently in order to reduce knee joint loads to prevent or     treat knee osteoarthritis as an alternative to surgical treatments.   "
144121|NCT01397968|"     This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared     to baseline in subjects with partial onset seizures not fully controlled despite their     treatment with 1 to 3 concomitant anti-epileptic drugs.      Also to evaluate the safety and tolerability of YKP3089.   "
144122|NCT01397955|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Julina for postmenopausal     osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in     clinical practice. A total 100 patients will be recruited and followed 3 years since starting     Julina administration.   "
144123|NCT01397942|"     To investigate if a high dietary intake of bitter and strong tasting vegetables have positive     health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and     postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers,     biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake     of mild and sweet modern vegetables or a normal western diet.   "
144124|NCT01397929|"     First in human, open-label, sequential dose escalation and expansion study of intravenous     BAL101553 in adult patients with advanced solid tumors.   "
144125|NCT01397916|"     The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia     (CLL) is studied.   "
144128|NCT01397877|"     This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of     initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.      Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending     on the group of patients. The primary endpoint is the non-progression rate at 3 months (12     weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the     non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive     disease (high grade tumor = stratum 2).      Disease progression is defined by the RECIST 1.1 criteria   "
144129|NCT01397864|"     This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients     treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form     (Ruconest), to observe adverse events and insufficient efficacy, and to assess the     immunological profile following single and repeated treatment with Ruconest.   "
144130|NCT01397851|"     Preliminary evidence from ongoing research provides strong indications that protecting     farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa.     The study team invests in experimental research to investigate this conjecture in more     detail.   "
144131|NCT01397838|"     Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone     degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to     evaluate the safety of Pro-bone.   "
144132|NCT01397825|"     This is a single-arm, open-label, multicenter, dose escalation, phase 1-2 study of alisertib     (MLN8237) administered in patients with relapsed or refractory diffuse large B-cell lymphoma     (DLBCL)/transformed follicular lymphoma (TFL) treated with rituximab and vincristine. The     study has three parts as follows:      Part 1, Phase 1: Safety lead-in cohort to evaluate alisertib (MLN8237) and rituximab.      Part 2, Phase 1: Dose escalation cohort to evaluate alisertib (MLN8237) + Rituximab +     Vincristine and determine Phase 2 dose. Patients with other types of B-cell lymphoma     (including mantle cell or Burkitt's lymphoma may enroll in Parts 1 and 2.      Phase 2: Alisertib (MLN8237) + Rituximab + Vincristine in patients with relapsed or     refractory DLBCL or TFL at recommended Phase 2 dose.   "
144133|NCT01397812|"     The purpose of this study is to demonstrate and validate a breath test for detection of     biomarkers of heart transplant rejection (Grade 2R heart transplant).   "
144134|NCT01397799|"     This Phase 1b study will determine the maximum tolerated dose of KX2-391 given as a     once-daily dose, in elderly patients with acute myelogenous leukemia.   "
144135|NCT01397786|"     The purpose of this study is to assess the long-term safety, tolerability and efficacy of     oral OPC-34712 as monotherapy in adults with schizophrenia.   "
144136|NCT01397773|"     The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal     dialysis and those in the pre-dialysis period; and to compare these groups with the control     group; so as to investigate the eligibility of it as a reliable marker of inflammation;     relationship with other inflammatory markers and carotis intima media thickness.   "
144137|NCT01397760|"     The purpose of this study is do describe the experience in the use of omalizumabe, in a real     life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient     clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed     will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations,     emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma     medication).   "
144138|NCT01397747|"     The primary objective is to determine the sensitivity and specificity of the Exact Colorectal     Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method.     Lesions will be confirmed as malignant by histopathologic examination.      The secondary objective is to compare the performance of the Exact CRC screening test to a     commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions     will be confirmed as malignant or precancerous by colonoscopy and histopathologic     examination.   "
144139|NCT01397734|"     In this research study, the investigators are looking to see whether the combination of     arsenic trioxide with a tyrosine kinase inhibitor is safe, and what effects it has on chronic     myelogenous leukemia.   "
144140|NCT01397721|"     The Multi-Ethnic Study of Atherosclerosis (MESA) - Chronic Obstructive Pulmonary Disease     (COPD) Study aims to characterize the pulmonary vascular changes and their biology in early     COPD using imaging, gene expression profiling and peripheral cellular measures.   "
144141|NCT01397708|"     This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in     combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a     protein that may improve the body's natural response to disease by enhancing the ability of     the immune system to kill tumor cells and may interfere with blood flow to the tumor.      The main purpose of this study is to evaluate the safety and tolerability of tumor injections     of INXN-2001 given in combination with different doses of INXN-1001.   "
144142|NCT01397695|"     Terence M. Davidson, MD is conducting a research study to find out more about the topical     application of Avastin (proper chemical name is bevacizumab) in the treatment of epistaxis     (nose bleeding) in patients with Hereditary Hemorrhagic Telangiectasia (HHT).   "
144143|NCT01397682|"     The goal of this research study is to collect clinical data, comprehensive geriatric     assessment, risk factors, biological data and blood samples from inpatients aged 65 and older     at the INRCA research hospitals (Italy). All data will be stored in a research bank and used     to better clarify the mechanisms underlying the condition of frailty in aged patients. The     database will be created on the INRCA server platform by establishing a safe HTTPS protocol.   "
144144|NCT01397669|"     To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and     non-acute HIV-infected adults        1. To compare the immunophenotyping of the gut mucosa to that of the peripheral blood in          HIV negative and in non-acute HIV-infected subjects        2. To compare the immunophenotyping of the peripheral blood in HIV negative and non-acute          HIV-infected adults to the findings from acutely HIV-infected subjects in the          WRAIR#1494/RV254/ SEARCH 010 study        3. To compare immunologic markers in the genital compartment compared to the peripheral          blood in HIV negative and non-acute HIV-infected adults to the findings from acutely          HIV-infected subjects in the WRAIR#1494/RV254/ SEARCH 010 study        4. Archive samples for immunologic and virologic testing   "
144145|NCT01397656|"     STUDY OBJECTIVES The overall goal of this study is to compare bystander fatigue and CPR     quality after 5 minutes of continuous chest compressions versus the 2005 30:2 chest     compression to ventilation Resuscitation Guidelines, in a population aged 55 or greater.      More specifically, the investigators will compare each CPR ratio with regard to:        1. The achieved frequency and depth of chest compressions, and        2. Participant rating of their perceived level of exertion.      STUDY HYPOTHESIS      In a population aged 55 or greater, the new CPR recommendations will lead to:        1. less frequent and shallower chest compressions over the 5-minute study period; and        2. higher rating of perceived level of exertion when compared to the 2005 30:2 CPR ratio.   "
144146|NCT01397643|"     Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon     fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence     regarding the optimal treatment and outcome of these fractures within the elderly population     with one case series in the literature describing 13 patients. Our trial includes all     patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic     Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial     will be randomised to operative fixation using one of two treatment methods. Patients in the     nonoperative group will be place in a sling for two weeks and then allowed to mobilise under     supervised physiotherapy as per normal protocol. For those patients in the operative group,     tension band wire of plate fixation will be employed depending on the choice of their     supervising consultant. Patients will be evaluated over a one year period following their     treatment.   "
144147|NCT01397630|"     The ultimate objective is to test the hypothesis that an 'accelerated titration' protocol for     labour augmentation with oxytocin reduces the risk of caesarean births relative to a 'gradual     titration' protocol.      The aims of this pilot feasibility are:        1. To assess the feasibility of a large multi-centre randomized control trial comparing the          two above oxytocin protocols (accelerated titration versus gradual titration for          correction of dystocia).        2. More specifically, to identify potential challenges in the study implementation,          particularly with respect to patient recruitment, randomization, blinding, and          compliance/adherence to the labour management guidelines and study protocols.        3. To obtain preliminary data on the acceptability of the accelerated oxytocin titration          protocol among obstetrical providers and participants.   "
144148|NCT01397617|"     The purpose of this study is to determine the survival rate, marginal bone resorption, soft     tissue health and maintenance of the NobelActive Internal and External implants and to make     comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.   "
144149|NCT01397604|"     The advent of vaccines contributed to major improvements in human morbidity and mortality due     to infectious diseases such as polio, small pox, measles and diphtheria. However infectious     diseases like HIV, malaria and tuberculosis continue to be major causes of death worldwide     and conventional vaccine strategies have not been successful. The fundamental problem is that     current protein based vaccines do not elicit the necessary T-cell immunity. Experimentally,     adjuvants can be given in conjunction with a vaccine to activate and mature the dendritic     cell (DC), which can then direct an immune response to enhance T-cell immunity. One family of     potential adjuvants functions through the activation of Toll-like receptors (TLR) on the DC.     Major gaps exist in our understanding of adjuvant effects in humans. We hypothesize that a     synthetic adjuvant directed to activate TLR4 (GLA) will safely stimulate the innate immune     system when administered subcutaneously (SC) or intramuscularly (IM). Importantly, in     contrast to other adjuvant trials in which adjuvant is combined with an antigen or vaccine,     GLA will be tested in isolation. This is because we anticipate the future administration of     GLA with our dendritic cell targeted HIV vaccine. A DC-targeted vaccine cannot be given     without an immune stimulating adjuvant due to potential risk of inducing immune tolerance.     Therefore, in order to understand the specific contributions of GLA versus the DC-targeted     vaccine, we need to understand the GLA effects in isolation. The safety and tolerability of 2     different formulations of GLA (GLA-SE vs. GLA-AF) administered by 3 different routes (SC, ID,     IM) will be the major focus of this trial. The second focus will be characterizing the innate     immune response by assessing systemic cytokine and chemokine levels and determining global     gene regulation following GLA stimulation. The third focus will be on the cellular effects of     GLA, specifically on blood monocytes and dendritic cells. Monocytes may represent a large     pool of inducible potent DC (monocyte-derived DC), however these cells have not been well     characterized in humans. We will investigate the effects of GLA stimulation on the peripheral     blood monocyte subsets that might give rise to monocyte-derived DC.   "
144150|NCT01397591|"     This phase II trial studies how well giving ofatumumab together with bortezomib works in     treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma     (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block     cancer growth in different ways. Some block the ability of cancer cells to grow and spread.     Others find cancer cells and help kill them or carry cancer-killing substances to them.     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for     cell growth. Giving ofatumumab together with bortezomib may help kill more cancer cells   "
144151|NCT01397578|"     This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to     evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET     imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.   "
144152|NCT01397565|"     Laparoscopic cholecystectomy is one of the most commonly performed operations in general     surgery and is considered the standard of care for cholecystectomy for benign biliary     disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is     associated with less postoperative pain, quicker recovery time and an improved cosmetic     result.      Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the     umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of     two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to as     needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars     with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further     reduce postoperative pain and recovery time as well as improve cosmetic results following     laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing     conventional to minilaparoscopic cholecystectomy.   "
144153|NCT01397552|"     Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will     be conducted on subjects that have not had previous injections or have not had an injection     in the last 12 months. Subjects must be receiving one level injection and not had prior     surgery at that level.   "
144154|NCT01397539|"     The primary objective of the study is to evaluate the safety and tolerability of a range of     BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to     moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study     population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of     BIIB037 after single-dose administration.   "
144155|NCT01397526|"     Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and     hypothermia in children. The oedema formation is due to increased fluid transport from blood     to tissue. This transcapillary fluid transport is dependent on differences in interstitial     and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes     in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary     bypass in children. The study hypothesis is that oedema developed during cardiopulmonary     bypass and hypothermia is caused by increased micro vascular protein leakage and reduced     colloid osmotic pressure gradient through the capillary membrane.   "
144156|NCT01397513|"     The fibrin network is an important component of an arterial thrombus and its structure     influences the degradation of the formed clot. A tighter and less permeable fibrin network,     which is less susceptible to fibrinolysis, is formed in patients with manifest cardiovascular     disease (CVD) or conditions associated with increased risk of atherothrombotic complications.     In a previous study we have shown reduced fibrin network permeability in patients with type 1     diabetes, which may contribute to their increased risk of CVD. Low dose aspirin treatment is     standard in management of CVD; however, the effect seems reduced in patients with diabetes.     Our previous studies have shown that aspirin treatment alters the fibrin network in     non-diabetic individuals and increases the fibrin network permeability. The effect of aspirin     on fibrin network formation in patients with diabetes is unclear.      We hypothesized that patients with type 1 diabetes might need higher doses of aspirin than     the recommended low dose (75mg) treatment to gain effects on fibrin network permeability, and     that the effects of aspirin treatment on fibrin network in these patients are influenced by     the glycemic control.   "
144157|NCT01397500|"     Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury,     ischemic stroke, subarachnoidal hemorrhage): the effects of hormone replacement on cognition,     quality of life and body composition Randomized, controlled, 3 arm (group 2: double-blind;     groups 1 and 3: open), multi-center, pilot study (Phase II)   "
144158|NCT01397487|"     The aim of this study to evaluate the effect of embryo biopsy on blastocyst development and     implantation rate.   "
144159|NCT01397474|"     -  Impaired peripheral perfusion is related to worse outcome in critically ill patients.          Although this is known, these parameters have never been used as target for hemodynamic          therapy.        -  We hypothesize that targeting of fluid administration on parameters of peripheral          perfusion might prevent excessive fluid administration, leading to less formation of          tissue edema, less respiratory dysfunction and shorter duration of mechanical          ventilation in critically ill patients.   "
144160|NCT01397461|"     This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for     ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo     comparison), superiority clinical study comparing ozenoxacin cream versus placebo and     retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or     bullous impetigo.   "
144161|NCT01397448|"     The primary objective of this study to evaluate the effect of preventing recurrence of     gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or     Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose     aspirin and thereby examine the superiority of E3810 over Teprenone.   "
144162|NCT01397435|"     The bone status in Gaucher disease is very difficult to monitor precisely in children. This     is a major problem because lack of optimal treatment, especially enzyme replacement, may     cause irreversible severe bone damage that will impact an affected person's life. Currently,     there are qualitative (subjective) methods, such as Magnetic resonance Imaging (MRI), to     gauge the response to treatment. A quantitative (objective) measurement of Gaucher cell     presence and activity in bone marrow could help with more precise and accurate monitoring of     bone marrow disease in patients both treated and not (yet) being treated with enzyme     replacement. The investigators will evaluate the efficacy of Magnetic Resonance Spectroscopy     (MRS) as a quantitative assessment of bone marrow involvement in Children with Gaucher, and     examine how this result correlates with semiquantitative MRI scales and overall disease     severity.   "
144163|NCT01397422|"     This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group     study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral     capsules, an extended release formulation of amantadine, dosed once daily for the treatment     of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel     pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma     concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms     of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may     reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and     iii) a reduced initial rate of rise in plasma concentration, which is expected to improve     overall tolerability of amantadine.   "
144164|NCT01397409|"     This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of     the safety of AGN-150998 administered as a single intravitreal injection to patients with     advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are     randomized, double-masked, comparisons of the safety and treatment effects on retinal edema     and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive     patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a     fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest     tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on     retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of     AGN-150998.   "
144165|NCT01397396|"     The additional effect of inspiratory muscle training as an adjunct to a general exercise     training program in patients with COPD with inspiratory muscle weakness will be studied. The     main hypothesis is that inspiratory muscle training combined with an exercise training     program improves functional exercise capacity more than an exercise training program without     the addition of an inspiratory muscle training program.   "
144202|NCT01396915|"     This study is designed to assess the effect of a diet-controlled nutrition program utilizing     an egg-based higher protein diet on muscle composition and size, and indices of metabolic     health and markers of systemic inflammation in older men and women who are slightly     overweight.   "
144166|NCT01397383|"     The investigators would like to evaluate the effect of serum 25-hydroxy vitamin D level on     post-operative short-term functional outcomes after total hip arthroplasty (THA).      Hypothesis: Patients with low serum vitamin D level will have less within-patient improvement     in pre- to 6 week, 1 year, 2 year and 5 year post THA WOMAC scores, SF-36 scores, and     performance-based tests(get up and go test and 2 minute walking test) compared to patients     who do not have a low vitamin D levels.      Also, Patients with low serum vitamin D level will have a higher rate of postoperative thigh     pain or periprosthetic fracture.   "
144167|NCT01397370|"     The purpose of the study is to evaluate the safety and tolerability of multiple ascending     oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and     to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple     oral administrations.   "
144168|NCT01397357|"     The purpose of this study is to evaluate CARDIAC MAGNETIC RESONANCE UTILITIES IN THE ISCHEMIC     HEART DISEASE as topographical correlation between ischemic territory injury and coronary     angiography.   "
144169|NCT01397344|"     Doctors' attire has known to impact patients' trust and confidence for better clinical     practice. However, few survey research regarding this topic has been conducted in traditional     asian medicine field. The aim of our study is to determine whether traditional medicine     doctor's attire impacts on patients' confidence and trust.      Participants will be given randomly one set of photographs from the 2 kind of photographs,     i.e., photographs of a male or female doctor, each set dressed in 4 different styles.      After this, they will be asked to report their preferences for the 4 styles of dress     according to given questions and they will answer the degree of their feeling on the     importance of Korean Medicine doctor's appearance.   "
144170|NCT01397331|"     The aim of the study is to delineate and compare the changes in coupled mechanical properties     of left ventricle and arterial vascular bed caused by two popular anesthetic protocols     commonly used in cardiac surgery (intravenous, based on the infusion of propofol, versus     inhalational, based on isoflurane) on different stages of the surgery.   "
144171|NCT01397318|"     Many pregnant women experience stress, fatigue, and poor sleep quality that may influence     infant outcomes such as prematurity and low birthweight through immunologic pathway of     biomarkers (serum cytokines and c-reactive protein). In contrast, TaiChi exercise, one kind     of physical activity, can increase pulmonary and immune functions and reduce stress may     therefore prevent pregnancy complications and further prevent adverse pregnancy outcomes;     however, its effects has not been explored in studies. Therefore, this study aims to     investigate relationships between prenatal stress, fatigue, sleep quality, biomarkers, and     infant outcomes; modified a TaiChi exercise program suitable for pregnant women; and test the     effects of the exercise on reducing stress and fatigue, promote sleep quality, modulate     biomarkers, and prevent adverse infant outcomes. Infant outcomes in the study will be     measured with gestational age and birthweight. The study is a three-stage longitudinal     interventional design.   "
144172|NCT01397305|"     The purpose of this study is to determine whether an optimal dose of [6R]     5,10-methylenetetrahydrofolate (Modufolin) in combination with pemetrexed are effective in     pre-operative treatment of patients with resectable rectal cancer.   "
144173|NCT01397292|"     The purpose of this research study is to examine the safety, tolerability, and effectiveness     of currently available pulmonary procedures when used to diagnose or treat different     diseases.      This study will collect information that may influence the outcome of the procedure and     identify factors that may affect the procedures yield or safety. The information will be     entered into a registry or data storage.   "
144174|NCT01397279|"     Type 2 diabetes is associated with hepatic insulin resistance. One consequence of insulin     resistance of the liver is an altered hepatic glucose metabolism. This study investigates     whether the whole body (M-value) and hepatic insulin sensitivity obtained by hyperinsulinemic     euglycemic clamp is influenced by a preceding intravenous glucose tolerance test (Botnia     Clamp) in subjects with type 2 diabetes.   "
144175|NCT01397266|"     In a randomized, double-blind controlled trial the investigators will evaluate the efficacy     of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative     analysis - such behavior and possible behavioral consequences related.   "
144176|NCT01397253|"     Communication between physicians caring for a patient in the hospital and that patient's     primary care provider is less than optimal, and can lead to diminished health care quality     and safety. This project will lead to better communication between physicians and could     decrease medication errors that tend to occur as the patient goes from hospital to home.   "
144177|NCT01397240|"     The purpose of this study is to research the safety and efficacy of Albis® for the prevention     of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.   "
144178|NCT01397227|"     The purpose of this study is to assess the safety, tolerability and immunogenicity of two     dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad)     Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the     protective efficacy of the higher dose level in an experimental malaria challenge.      The study will be in 3 phases:        1. a dose escalation / vaccination phase in which both dose levels will be tested        2. a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01          5x10^10 vp dose level, together with six infectivity control subjects, will be exposed          to experimental challenge with Plasmodium falciparum        3. a long term follow up phase in which all subjects who received active vaccine from both          dose levels and/or malaria challenge will be included   "
144179|NCT01397214|"     Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety     compared to Megace OS.      Phase I study divided into 3 parts written as belows.      Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace     OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers   "
144180|NCT01397201|"     The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses     twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI)     at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic     patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS)     as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%)     and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at time of randomisation   "
144181|NCT01397188|"     PiCCO has become a widely used haemodynamic monitoring device in the management of shock     patients in ICU patients nowadays. But the effects on outcome of use of Picco, such as     hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical     ventilation-free days and change of lactate and BNP in shock patients has not been     determined. Patients will be randomly assigned to a Picco group or the control group,     hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical     ventilation-free days and change of lactate and BNP will be observed. The conclusion will     supply evidence for the clinical effectiveness of Picco in shock patients.   "
144182|NCT01397175|"     The primary objective of this study is to compare the rate of device-oriented composite     consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget     vessel, and clinically indicated target lesion revascularization among the patients treated     with EES, ZES-R, or BES at 24-month clinical follow-up post-index procedure. Trial end points     are summarized in Table I. The hypothesis is that BES is equivalent to EES or BES is     equivalent to ZES-R at the primary end point.   "
144183|NCT01397162|"     The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses     twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA     MDI) at a dose of 88 mcg b.i.d and placebo b.i.d. over an 8-week treatment period in     asthmatic patients aged 12 to 65 years inadequately controlled on short-acting-beta-agonist     (SABA) prn therapy only as demonstrated by a decrease in forced expiratory volume in one     second (FEV1) range10 to 25% and an asthma control questionnaire (ACQ-6) equal or greater     than 1.5 at time of randomization   "
144184|NCT01397149|"     The aim of this study is to find the appropriate dose of eltrombopag in thrombocytopenic CLL     patients, that shortens the duration of the thrombocytopenia and achieves platelet count of ≥     100/nl prior to the start of chemotherapy containing alkylating agents and/or Purine     Analogues.   "
144185|NCT01397136|"     In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in     embryo culture medium, in order to investigate whether both cell-free nucleic acid types may     provide additional, reliable, predictive parameters for embryo viability and implantation     potential.   "
144186|NCT01397123|"     The purpose of this study is to assess the effects of a six months nutrition intervention,     delivered and taught by classroom teachers with in-service nutrition training, on the     prevention of overweight and obesity among children in grades 1 to 4.      In this randomized controlled trial, 464 children from seven elementary schools were     allocated to a six months nutrition educational intervention by their own teachers or to     standard care. Intervened teachers had 12 sessions of three hours each with the researchers     throughout six months, according to the following topics: nutrition and healthy eating     (sessions 1 to 4); the importance of drinking water (session 5); strategies to encourage     fruits and vegetables consumption and to decrease high energy-density foods intake (sessions     6 to 8); strategies to increase physical activity (sessions 9 and 10); and healthy cooking     activities (sessions 11 and 12). After each session, teachers were encouraged to develop     activities in class that focused on the learned topics. Sociodemographic, anthropometric,     dietary, and physical activity assessments were performed at baseline and the end of     intervention.      We expect that fewer intervened children become overweight and the consumption of fruit and     vegetables will be higher. In addition, we expect a less consumption of low-nutrition high     dense foods.      We also expect to provide further support to decrease overweight epidemic, involving     classroom teachers in a training intervention and making them dedicated interventionists.   "
144187|NCT01397110|"     The purpose of this study is to investigate the influence of physical training on exercise     capacity, quality of life, functional class, oxygen consumption and right ventricular     function in patients with severe associated pulmonary arterial hypertension (APAH) as part of     a congenital heart defect with / without Eisenmenger's Syndrome   "
144188|NCT01397097|"     The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years     inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant     over a period of 12 months.      Secondary objectives are to observe the bleeding patterns, adverse event profiles and the     occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions     and implant site complications will be collected.   "
144189|NCT01397084|"     Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving     rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant     improvement of heartburn after 8-week treatment.   "
144190|NCT01397071|"     Avocados are naturally rich in antioxidants, or beneficial compounds, that can help prevent     many diseases, like atherosclerosis (hardening of the arteries). When foods that are high in     fats are eaten, certain harmful compounds can be absorbed, which can lead to atherosclerosis.     One harmful compound is called malondialdehyde, or MDA. This compound can be measured in the     blood and the urine after a person eats a high fat meal. Antioxidants found in herbs and     spices may lower the absorption of MDA, which could help prevent the development of     atherosclerosis.      This study will determine whether the beneficial compounds of avocado can reduce absorption     of MDA. This will be tested by asking healthy males to eat a high fat ground beef patty with     or without avocado and then measuring the amount of MDA in their blood and urine samples.     Blood flow will also be measured. Healthy men have been chosen for this study because eating     high fat hamburger patties can easily mimic in them the condition that causes     atherosclerosis. Avocadoes are rich in antioxidiants, which have been shown in previous     studies to reduce the absorption of harmful compounds, like MDA, that are formed during     cooking. The results from this study may help to explain how high fat foods can be harmful to     the body and how beneficial antioxidants from herbs and spices can protect the body.      This will be determined from blood and urine samples after the subjects are given two     different meals: a) a plain cooked ground beef patty, and b) or avocado with a cooked ground     beef patty.   "
144203|NCT01396902|"     As a participant in these research program you will be a parent of a child born at Wesley     Medical Center who plan to use Carriage Park Pediatric Clinic for your child's care. Mobile     phone text messages will be sent to remind you of your child's immunizations.      The long term research goal is to increase childhood immunization rates by improving parental     health literacy through an innovative text messaging system regarding immunization schedules     for children under the age of six.   "
144191|NCT01397058|"     Background. Human herpes viruses establish lifelong latency after primary infection and may     reactivate in immunosuppressed patients causing significant morbidity and mortality. In     immunocompetent patients, although reactivation may occur disease development is deterred by     the competent host immune response. Recent studies indicate that approximately one third of     CMV seropositive immunocompetent ICU patients present with CMV reactivation associated with     poor outcome, potentially secondary to the stress incurred. CMV reactivation among     immunocompetent critically ill children has not been assessed.      Study Hypothesis: Identifiable risk factors associated with CMV reactivation exist and may be     used for future assessment of antiviral prophylaxis administration.      Aim: Primary aim is to identify risk factors associated with CMV reactivation and poor     outcome in immunocompetent children and adults under severe stress. Whether CMV reactivation     occurs in critically ill children and its clinical implications remains to be determined.     Secondary aim is to study the role of cellular signaling pathways of inflammation and     specific adaptive immunity during this process.      Work packages: A multicenter observational prospective study will be conducted among CMV     seropositive pediatric and adult ICU patients. Patient clinical progress, laboratory     findings, management, and complications will be recorded during the 28 days following ICU     admission. Salivary free cortisol levels, plasma catecholamines, and serum cytokines levels     will be measured to assess stress. CMV reactivation will be evaluated weekly by detecting     CMV-DNA in peripheral blood and bronchial wash samples with real-time PCR. In a patient     subsample, the nuclear factor κB and intracellular GC receptor will be measured in peripheral     blood monocytes to study cellular signaling pathways of inflammation. The adaptive immune     response to CMV infection following in vitro viral polypeptide stimulation will be     prospectively examined in a subset of patients.      Expected Results: The study will provide original data on critically ill children. Further     knowledge regarding risk factors associated with CMV reactivation and poor outcome will be     accumulated. Novel information regarding the role of cellular inflammation and specific     adaptive immune responses during CMV reactivation will be gathered.   "
144192|NCT01397045|"     Aim of this prospective randomized study is to assess the safety and efficacy of     video-assisted lung segmentectomy (Group B) comparing with mini muscle-sparing thoracotomy     (group A) during diagnostic process for pulmonary nodules.   "
144193|NCT01397032|"     Children with social anxiety will be randomly assigned to either Attention Bias Modification     Treatment (ABMT) designed to direct attention away from threat or a placebo control condition     not designed to change attention patterns. Outcome measures will be depression and social     anxiety symptoms as measured by gold standard questionnaires as well as diagnosis of social     phobia disorder and symptom counts derived from structured clinical interviews with children     and their parents.      We expect to see significant reduction in social anxiety symptoms in the Attention Bias     Modification Treatment (ABMT) group relative to the placebo control group.   "
144194|NCT01397019|"     Treating patients with initial local non-resectable pancreatic cancer with a combination of     oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in     potentially resectable patients, will result in a high rate of tumor shrinkage allowing     subsequent resection in patients with initial borderline resectable tumors and improved     overall survival for all patients.   "
144195|NCT01397006|"     The purpose of the study is to evaluate whether pregabalin is effective in treating subjects     who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for     treatment of fibromyalgia. the purpose of the study is to see if subjects identified through     their primary care physicians who have fibromyalgia and have had symptoms for less than one     year respond to pregabalin and to identify characteristics of that response.   "
144196|NCT01396993|"     Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast     cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are     sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic     surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has     been demonstrated by several authors using restrospective analyses. However, no prospective     observational trial has been done to objectively evaluate cosmetic and oncologic outcome     comparing BCT with iTOP. The aim of this study is to investigate this issue within a     prospective non randomized observational trial at the Medical University Vienna.   "
144197|NCT01396980|"     -  SDF is validated by measuring changes in microcirculation in sepsis patients with MOF          (Boerma studies).        -  SDF is validated by measuring changes in microcirculation in stable chronic hemodialysis          patients (NDT 2009 Bemelmans).        -  Ultrafiltration in stable chronic hemodialysis leads to a decrease in sublingual          microcirculatory flow (NDT 2009 Bemelmans).        -  Trendelenburg position improves the sublingual microcirculatory flow at the end of          hemodialysis treatment (NDT 2009 Bemelmans).        -  Hemodialysis with ultrafiltration leads to a significant reduction of myocardial          perfusion and cardiac output (NDT 2009 Dasselaar)        -  Cardiac output measurement during dialysis is not practical.        -  BVM is a validated method for hypotension due to ultrafiltration to prevent the amount          of ultrafiltration online change based on the measured haemoconcentration (ref Dasselaar          et al NDT 2005).        -  BCM is a validated measurement to the dry weight in hemodialysis patients measured by a          bioimpedance technique (NDT Passauer et al 2009).   "
144198|NCT01396967|"     During cataract operations a capsulorhexis is being performed. This is done in order to     enable the removal of lens material while keeping the capsule intact in order to put inside     the lens capsule an artificial intra ocular lens.      The capsulorhexis must be round and with regular edge and no tears. While performing a     cataract surgery we use phako emulsification machine that sends an ultrasonic wave that     creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and     sucks the fluid and the lens material of the creaked lens.      The round shape and the regularity of the capsulorhexis are a must in these surgeries since     the lens capsule must stay intact and stable in order to enable the phacoemulsification and     the implant of the artificial lens.      Today capsulorhexis are done with a bent needle or with special forceps; the act of     capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve     is relatively long and difficult.      The proposed device enables a capsulorhexis which is round and has regular edges, done almost     automatically and is predicted. The learning curve is short and easy. The capsulorhexis is     done through the original operating wound with no need to widen it.   "
144199|NCT01396954|"     Glucose metabolism disorders (GMD) can be present in an overt and a subclinical way. They     have negative impact in survival of patients with liver cirrhosis (LC). Their prevalence has     not been determined in compensated cirrhotic patients.   "
144200|NCT01396941|"     This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in     comparison to normal sleep, will:        1. Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the          hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.        2. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of          endogenous glucose production, gluconeogenesis and glycogenolysis.   "
144206|NCT01396863|"     The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration     (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.      The study consist of two examination days placed one week apart. 12 HD patients will be     recruited to the study. The patients will be randomly placed in two groups: Pre-dilution     hemodiafiltration during the first examination and low flux hemodialysis during the second     day or vice versa.      Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The     MRI-data will later be processed to estimate brain volume changes during the two types of     treatment.   "
144207|NCT01396850|"     BBB dysfunction has been indicated in some groups of schizophrenia patients by measuring     increased albumin and immunoglobulin (IgG) cerebrospinal fluid (CSF) levels. Most of the     authors described a raised protein level in 5-20% of the schizophrenic patients (Muller &     Ackenheil, 1995). Increased S100B levels were demonstrated in the serum of patients suffering     from schizophrenia as well as depression, and this may reflect increased BBB permeability.     Furthermore, this increase remains in those patients who develop a residual state with     relevant negative symptoms, whereas S100B levels normalize in recovering patients (Shalev,     Serlin & Friedman, 2009). CSF albumin and CSF IgG values correlate significantly with some of     the SANS (Scale for the Assessment of Negative Symptoms) subscales and the SANS total score,     this shows the correlation between BBB permeability and behavioral changes. It is important     to say that although negative symptoms are often signs of chronicity of the disease, the     abnormal CSF findings in Muller's experiment (1995) are not related to the duration of the     disease, because the patients were quite young and the duration of the disease was less than     3 years.      The investigators hypothesize that a primary vascular pathology, which leads to BBB     breakdown, will result a leakage of serum-derived vascular components in to the brain tissue     and may cause brain dysfunction such as disturbed thinking processes, mood and behavior, as     we can see in psychiatric patients.   "
144208|NCT01396837|"     The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in     patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.   "
144209|NCT01396824|"     The purpose of this study is to determine whether nutritional status or body composition     influences the prognosis of heart failure patients.   "
144210|NCT01396811|"     The purpose of this study is to determine if a topical antifungal cream is safe and effective     for the treatment of tinea pedis.   "
144211|NCT01396798|"     Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill     Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through     prospective observational data collection concerning specific items from the clinical and     technical examination in diagnosing serious infections, such as meningitis, sepsis,     pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate     a vital signs and symptoms rule derived from multiple low to high prevalent settings of     acutely ill children.   "
144212|NCT01396785|"     The purpose of this study is to determine if a topical antifungal cream is safe and effective     for the treatment of tinea pedis.   "
144213|NCT01396772|"     The purpose of this study is to determine if a 6-month community-based prediabetes lifestyle     and behaviour change intervention (called, PREPARE) for middle and older adults with     prediabetes will result in positive lifestyle behaviour change.   "
144214|NCT01396759|"     Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted     to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1).     Nasal CPAP (NCPAP) is effective in correcting hypoxemia and contributes to reducing the     number of children requiring endo-tracheal intubation and mechanical ventilation (2). CPAP is     most frequently delivered to neonates using conventional mechanical ventilators, and thus     there is minimal or no cost saving. There are other ways of delivering CPAP, such as     Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an     air-oxygen blender, a humidifier and a T-piece.(3). The expiratory arm is inserted in a     bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory     tubing that remains under water. Robust equipment is now available at a fraction of the cost     of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical     ventilation, such as lower cost, ease of application by nursing staff, lower risk of     complications, and has been proposed as an inexpensive method of delivering CPAP in     developing countries (3).      High flow air/oxygen mix is useful in reducing the indication of mechanical ventilation (4);     however, there is a lack of randomized studies comparing it with bubble CPAP or with standard     flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per     kg per minute of blended air/oxygen mix, usually with a low fraction of inspired oxygen (say     25-40%). It is easy to apply, but requires additional equipment to standard oxygen therapy,     and closer monitoring. High flow delivers uncertain levels of CPAP, so it is not clearly     superior to bubble-CPAP, and there have been no controlled comparative trials of these two     techniques.      Pneumonia and malnutrition are two of the most common co-morbidities in children in     developing countries (5). In hospitals in resource-poor settings, children with severe     malnutrition and pneumonia often present with respiratory distress with or without severe     hypoxaemia and impending respiratory failure (6). They initially receive O2 supplementation     through nasal prong or face mask. Support from bubble CPAP might help to effectively treat     hypoxaemia, improve respiratory function, avoid the need for mechanical ventilation and its     complications, and reduce mortality.      Almost half of the patients admitted in the intensive care unit of the Dhaka hospital of     ICDDR,B present with hypoxaemia, many with impending respiratory failure. Children with     pneumonia also invariably have severe malnutrition with or without diarrhoea (Chisti MJ, MMed     thesis, unpublished data). They often need mechanical ventilation, with attendant costs,     complications and high mortality rates. However, no published data are available about the     use of bubble-CPAP in children with pneumonia and malnutrition and there have been no     controlled trials of CPAP in developing countries.      The Hypothesis is:      In children with severe pneumonia and hypoxaemia the probability of treatment failure (see     definition below) will be significantly lower when respiratory support is initially provided     by bubble-CPAP or high-flow, humidified air/O2 mix by nasal prongs, compared to standard     oxygen flow.   "
144215|NCT01396746|"     The purpose of this study is to explore the relationship between cardiovascular function of     persons with post stroke conditions and their performance in three field tests. This is a     validation study, aiming to determine during which of two activities VO2 measurements better     express the functional restrictions caused by stroke, And to find out whether the Total Heart     Beat Index can be used in the case of stroke survivors for the prediction of mechanical     efficiency when measured during stair-climbing and of energy cost during treadmill walking.      The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity     testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of     external work, and therefore will show stronger correlation with functional tests     demonstrating the same ability, whereas TMW does not utilize the movement capability of     participants to the fullest.      Another hypothesis is that cardiac response to the exertion can be used as a predictor of     those measures during these exertions in the post stroke population.   "
144216|NCT01396733|"     Radioiodine (I-131) therapy is of proven efficacy for treatment of differentiated thyroid     carcinoma (DTC). However, loss of differentiation in recurrent or metastatic DTC which     decrease I-131 uptake may decrease the efficacy of I-131 therapy. Therefore, strategies to     improve I-131 uptake are mandatory. This study is an open label clinical study to evaluate     the effectiveness of alpha-lipoic acid (ALA) for improving I-131 uptake in recurrent or     metastatic of DTC with defective I-131 uptake.   "
144230|NCT01396551|"     Clinical study investigating the feasibility and safety of using an anchored Calypso     transponder in the airways of the lung for real-time monitoring of tumor location during     radiotherapy   "
144231|NCT01396538|"     Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical     detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive     referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to     mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics by     polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc alone in     patients with serum HBV DNA can be measured, then there may be occult HBV infection. In     different countries, Occult HBV infection in the Anti-HBc Alone group had significant     differences in the prevalence (2.9 ~ 22.8%) (2), but prevalence survey in Taiwan there are     very few studies on this , It is hoped to be able to investigation the prevalence of occult     HBV infection Among Anti-HBc Alone.   "
144250|NCT01396291|"     This study is being done to evaluate the efficacy and safety of asenapine as compared to     placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic     mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each     participant will receive open-label asenapine and matching placebo for 12 to 16 weeks.     Participants who meet stabilization criteria may then be randomized into one of the two study     arms (asenapine or matching placebo) to receive double-blind treatment for up to an     additional 26-weeks.   "
144217|NCT01396720|"     Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute     coronary events and coronary interventions. Several studies have shown that some patients are     resistant to clopidogrel. The resistance mechanism is not entirely clear, but at least in     part it is related to interactions between medications. Clopidogrel is a pro-drug converted     in vivo to its active metabolite by CYP2C19 and CYP3A in the liver. Consequently drugs that     inhibit the CYP2C19 can affect the production of the active metabolite and cause clopidogrel     resistance. Therefore the FDA has recently published a safety alert which recommends     avoiding cross treatment with clopidogrel and drugs that are expected to inhibit CYP2C19     (including omeprazole, fluvoxamine, cimetidine, fluconazole and others). Nevertheless there     no clear evidence in the literature for clinical relevance of such interactions.      Selective serotonin reuptake inhibitors (SSRIs) are group of antidepressant drugs that are     widely used for treatment of depression and anxiety. SSRIs are considered to be very safe     with favorable side effect profile, hence many patient after coronary events who suffers from     behavioral and emotional disturbances are treated with those drugs. However there are several     reports that SSRIs can inhibit platelet function and increase bleeding tendency particularly     in concomitant administration with aspirin. The proposed mechanism is blocking of platelets     serotonin reuptake that result in platelet dysfunction.      Fluvoxamine - is a member in the SSRI family and a potent inhibitor of the CYP2C19.     Theoretically fluvoxamine should have two conflicting effects on the response to clopidogrel.     Pharmacokinetically it is expected to decrease the clopidogrel responsiveness due to     inhibition of CYP2C19 and reduction in the production of the active metabolite. On the other     hand pharmacodynamically fluvoxamine may directly inhibit platelet aggregation due its     effect on serotonin reuptake, thus increasing the effect of clopidogrel. Other SSRIs that do     not interact with the CYP2C19 such as citalophram are expected to have only pharmocodynamic     effect on platelet aggregation.      Although both clopidogrel and SSRIs are widely used in the last decade and concomitant     treatment is quite common, no data is available about in influence of the interaction between     those drugs on platelet function and on clinical events. The net effect of fluvoxamine and     other SSRIs on platelet function in the presence of clopidogrel is not known.      The aim of the investigators study is to assess the effect of two SSRIs fluvoxamine and     citalophram on platelet aggregation and to test the effect of these drugs on the laboratory     response to clopidogrel, in healthy individuals.      Study design: randomized, double blinded, controlled crossover trial. Primary study end     point: Change in % platelet aggregation and VASP phosphorylation after treatment with     clopidogrel + fluvoxamine or clopidogrel + citalophram as compared to each drug alone.   "
144218|NCT01396707|"     This is an open-label, multicentre, prospective phase II trial designed to evaluate the     efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as     first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma     of the stomach or gastro-oesophageal junction.   "
144219|NCT01396694|"     All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction     will complete a psychological questionnaire prior to surgery. The 3 month outcomes including     pain and function will be examined using regression analysis to identify psychological     variables that may predict outcomes.   "
144220|NCT01396681|"     This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy     Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.   "
144221|NCT01396668|"     This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by     chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.   "
144222|NCT01396655|"     Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy     differ from those of early breast cancer.      The purpose of this study was to identify the clinical significance of potential predictive     and prognostic factors including serial FDG PET/CT in breast cancer patients treated by     neoadjuvant chemotherapy.   "
144223|NCT01396642|"     Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of     these deaths are attributable to prematurity and infection. With the increasing rate of     premature births in some settings, the mortality rate of over 50% among preterm babies in     some of the developing countries require inexpensive hospital-based strategies to prevent     fatal infections in newborns of these countries. As most of the deaths in preterm neonates     are attributable to their vulnerability of infection, a potential low cost intervention like     topical emollient therapy can be effectively directed to reduce infection related mortality     and morbidity in the developing countries. Topical emollient therapy reduces the rate of     infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss     consequently conserving heat and energy to promote growth.      The broad goal of the study is to improve the survival rate of hospitalized preterm neonates     in the developing countries by decreasing the incidence of infection using low-cost     interventions.      HYPOTHESIS:      It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day     of life in hospitalized preterm neonates reduces the incidence proportion of hospital     acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it     is hypothesized that the weight gain in the neonates receiving prophylactic application of     emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18     more as compared to the weight gain in the routine skin care group.   "
144224|NCT01396629|"     The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the     implantation of foldable intraocular lenses.   "
144225|NCT01396616|"     The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational     stability after implantation of TORIC IOL and to assess the post operative complications     after implantation of TORIC IOL.   "
144226|NCT01396603|"     This study will evaluate a new imaging technology, termed optical frequency domain imaging     (OFDI) for detecting and diagnosing pulmonary malignancy in the central airways.   "
144227|NCT01396590|"     The purpose of this study is to determine that six 2-mg tablets of perampanel are     bioequivalent to one 12-mg tablet of perampanel.   "
144228|NCT01396577|"     The purpose of this study is to determine that three 2-mg tablets of perampanel are     bioequivalent to one 6-mg tablet of perampanel.   "
144229|NCT01396564|"     HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations     and insulin resistance than metformin in children with Type 2 Diabetes (T2D).      MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American     Diabetes Association (ADA) were included, not under treatment or who had been treated     exclusively with diet and exercise or who only received an anti-diabetic agent, as well as     those with a history of insulin use who had not applied insulin within 1 month before the     initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are     recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin.      STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of     resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin     concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired t     test. Lineal or logarithmic regression analysis is used to evaluate the relationship between     homeostasis model assessment of insulin resistance (HOMA-IR) and resistin concentrations. The     statistical significance between variables is determined using ANOVA. The effect of     confounding variables is analyzed with a test of co-variance analysis. Statistical     significance is considered as p <0.05.   "
144233|NCT01396512|"     The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus     Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine     [CD.JEVAX™]) after a single dose vaccination to support product registration.      Primary Objective:        -  To demonstrate the non-inferiority of the antibody response 28 days after administration          of one dose of IMOJEV™ compared to the antibody response 28 days after administration of          one dose of the CD.JEVAX™ control vaccine.      Secondary Objectives:        -  To describe the immune response to Japanese encephalitis (JE) in both vaccine groups          using 50% plaque reduction neutralization assay (PRNT50) assays before and after a          single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.        -  To describe the safety of vaccination in all subjects up to 28 days and all serious          adverse events up to 6-month after vaccination.   "
144234|NCT01396499|"     The goal of this clinical research study is to find the highest tolerable dose of BKM120 that     can be given to patients with relapsed or refractory leukemia. The safety of BKM120 will also     be studied.   "
144235|NCT01396486|"     The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus     inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3     fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the     side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial     with children ages 5-12 years old with bipolar spectrum disorders.   "
144236|NCT01396473|"     The purpose of this study is to design and conduct research to tailor out of school time     evaluation materials so they are applicable to various settings in Boston, are efficient in     that minimal resources and time are used, and are useful to participants.   "
144237|NCT01396460|"     Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of     energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental     and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a     decrease in the values of RQ, which may be associated with increased lipid oxidation in the     postoperative period.      Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would     like to know how it functions among RYGBP patients.      The purpose of this study is to evaluate the RQ and DIT of patients in the post operative     phase and compare the result with a control group consisting of morbid obese population.   "
144238|NCT01396447|"     The objective of this study was to evaluate the efficacy, safety, and tolerability of     cariprazine relative to placebo for the treatment of patients with bipolar depression.   "
144239|NCT01396434|"     Prevenar 13 is safe for administration to Filipinos.   "
144240|NCT01396421|"     The purpose of this study is to compare the effectiveness, safety and tolerability of three     different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.   "
144241|NCT01396408|"     This research is being done because there is no treatment that will cure this type of cancer.     Although some types of chemotherapy can cause this cancer to shrink for a time, better     options are needed.   "
144242|NCT01396395|"     This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart     Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who     are taking standard treatment with stable symptoms will receive a 24-hour ambulatory     electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups.     The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of     the standard treatment for 12 weeks, while the control group will stay on standard treatment.     Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not     affect the primary endpoint may be adjusted per investigators decision.   "
144243|NCT01396382|"     Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The     68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and     resolution specifically for neuroendocrine tumors. The investigators will scan people with     this cancer and compare it to other conventional imaging methods to see if it improves     patient care.   "
144244|NCT01396369|"     PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone     levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the     ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require     2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum     hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic     ovaries.      This study is a prospective randomized pilot study designed to evaluate the effects of     flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in     polycystic ovarian syndrome (PCOS) patients.   "
144245|NCT01396356|"     You are being scheduled to undergo an ablation procedure to treat your atrial fibrillation.     Complications of ablation procedures include damage to structures near the heart from the     heat energy used during the ablation procedure. These complications include damage to the     esophagus (the tube through which food passes when you swallow) and stomach. A rare but often     fatal complication resulting from severe heat damage is called an atrio-esophageal fistula     (an abnormal connection between the heart and esophagus). However, the frequency of minimal     damage to the esophagus or nerves of the gut that may go unnoticed are not known.      This study is designed to determine how often atrial fibrillation ablation causes problems     with the stomach and esophagus.   "
144246|NCT01396343|"     The purpose of this study is to better understand multiple sclerosis (MS) in children and     adolescents, to learn if it differs from adult MS and to investigate if genes or     environmental exposures or a combination of both put children and adolescents at risk for     getting MS.   "
144247|NCT01396330|"     Introduction Stress is part of the investigators daily life, and means to cope with it allow     adaptation and survival. To this end, physiological pathways are activated, including     neuroendocrine, cardiovascular and metabolic responses. In short term, the majority of     consequences are beneficial, in the long run, however, chronic psychosocial stress may     constitute an increased risk for coronary heart disease, type 2 diabetes, and disability.      Acute mental stress induces an exaggerated release of stress hormones e.g. catecholamine and     cortisol which are thought not only to increase heart rate (HR) and blood pressure (BP) but     also to increase blood glucose levels. In clinical practice, patients and health care     providers are often confronted with questions concerning psychological stress as a possible     reason for glucose fluctuations. Whether stress itself or poor treatment adherence is     responsible for the altered glucose control remains often controversial. Differences in the     inter- and intraindividual response to stress have been suggested, but only a few small     studies have addressed the effect of acute psychological stress on glucose control in     patients with diabetes. Patients with type 2 diabetes may overestimate the effect of acute     psychological stress on glucose control but further studies are clearly needed to definitely     exclude or confirm a relevant effect of stress on the glucose control in diabetic patients.     For example, effects of longer lasting or repetitive events of psychological stress on     glucose concentrations still remain elusive. The aim of the present study was therefore to     investigate the effect of prolonged psychological stress by means of repetitive safe driving     training courses on glucose control in patients with diabetes.      Patients and Methods Forty patients with type 1 or insulin-treated type 2 diabetes attending     the outpatient-clinic of the Kantonsspital Frauenfeld or University Hospital of Zurich for     regular visits are invited to participate. Included are patients on any oral glucose-lowering     treatment and at least one daily injection of insulin, a valid driver license and written     informed consent given. Exclusion criteria are diabetes duration <2 years, pregnancy,     unstable coronary artery disease, limited visual acuity or unstable proliferative diabetic     retinopathy, uncontrolled hypertension (BP >160/95mmHg) and pituitary or adrenal disease. The     Ethics committee of the Kanton Thurgau approved the protocol and the study conform to the     principles outlined in the Declaration of Helsinki.      Study protocol Each patient completes a control and a stress testing day which takes place     consecutively in a randomized order. Randomization is performed by an uninvolved third     person. The study is carried out at the driving training area of the Touring Club Switzerland     at Hinwil. Patients are advised to have lunch before 12:00 a.m. and to abstain from food     thenceforth. Drinking mineral water remains allowed during the entire study days, and the     patients have to take their basal insulin and other medication as usual. Patients are advised     to arrive at the driving training area between 2:30 and 3:00 p.m. At arrival, a capillary     glucose measurement is carried out, and glucose concentrations ≥10mmol/l are corrected with     short-acting insulin analogues (glucose target 6 - 8mmol/l). Subsequently, no additional     adjustment with insulin is allowed during the study. Glucose concentrations ≤4mmol/l are     always corrected with administration of 10g carbohydrate (DextroEnergy® or orange juice). On     both study days, patients ingest a standard meal at 4:45 p.m. (i.e. 15min before the driving     training). Immediately after the meal, short-acting insulin is injected in knowledge of the     carbohydrate content (same dose on both days) or oral antidiabetics are ingested as usual.     Measurements of capillary and plasma glucose concentration, blood pressure, heart rate,     stress perception and salivary cortisol concentration are carried out in regular intervals     between 4 and 9 p.m. on both study days.      On the control day, patients are placed in a quiet room and are permitted to read. They also     have the possibility to leave the room and stay on a balcony.      On the stress testing day, patients complete a driving training with their car between 5 and     7 p.m. The driving training consists of 3 consecutive exercises: first, a slalom track on dry     and wet asphalt, secondly, a full braking exercise with water obstacles. Thirdly, the car is     hurled around by a mechanical plate and the patients has to regain control over it.   "
144248|NCT01396317|"     This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess the     tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in patients     with polymyalgia rheumatica (PMR).   "
144249|NCT01396304|"     Calcium alginate dressings with silver have been found to be safe and effective for use for     leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to     AqualCel Ag Dressing on the following parameters: No further progression toward infection     (bioburden), ease of application and removal, and percent progression to closure. The     secondary objective is to obtain photographic documentation of the leg ulcers during the     course of the study.   "
144251|NCT01396278|"     The aim of the study is to assess and compare efficacy and safety of BI 54903 at three     different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose     inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d.     over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately     controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume     in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or     greater than 1.5 at time of randomisation.   "
144252|NCT01396265|"     The objective of the current study is to investigate the effect of the P-gp inducer     rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers   "
144253|NCT01396252|"     The purpose of this clinical study is to assess the safety and tolerability of multiple oral     doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.   "
144254|NCT01396239|"     This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics     (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24     weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).   "
144255|NCT01396226|"     Medical Products Agency   "
144256|NCT01396213|"     A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and     safety of Larazotide Acetate in the treatment of patients with celiac disease who have     persistent symptoms despite being on a gluten-free diet.   "
144257|NCT01396200|"     The purpose of this study is to determine the feasibility of giving (i) rapamycin or (ii)     hydroxychloroquine (HCQ), with standard doses of infusional cyclophosphamide and pulse     dexamethasone (cy/dex) for patients with relapsed/refractory multiple myeloma, as well as the     feasibility of obtaining multiple blood and bone marrow samples during treatment to assess     the pharmacodynamic effects of the treatment.   "
144258|NCT01396187|"     This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability     and pharmacokinetics of multiple ascending doses of PF-05231023.   "
144259|NCT01396174|"     The investigators hypothesize that breast cancer survivors participating in a prosocial     online support group will have a significantly lower mean level of psychological symptoms     (anxiety/depression) and higher mean level of sense of purpose post-intervention than     participants in a standard online support group.   "
144260|NCT01396161|"     The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics     and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and     patients with type 2 diabetes mellitus.   "
144261|NCT01396148|"     Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with     sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be     studied in these patients. In addition, tumor responses and overall survival will be     assessed.   "
144262|NCT01396135|"     This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The     pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be     evaluated in Japanese, healthy, non-smoking subjects.   "
144263|NCT01396122|"     The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE     PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ     Prolapse.   "
144264|NCT01396109|"     Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms     such as loss of control of the bowel or bladder, and may also cause problems with patient's     sex life. The primary treatment is surgery, sometimes a mesh is placed in the pelvis to     support the weakened tissues, but mesh implants can cause complications.      This study is designed to determine the effectiveness and safety of GYNECARE PROSIMA* pelvic     floor repair system compared with the modified total pelvic floor reconstructive surgery with     mesh for the treatment of uterine prolapse.      Patients enrolled into the study will be followed up for up to 3 years after surgery.     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before     and after surgery, patient satisfaction through quality of life and sexual function     questionnaires before and after surgery, and peri-operative complication rates will be     evaluated.   "
144265|NCT01396096|"     This proposal is designed to (1) establish the feasibility of a research strategy for     discovering ethnic differences in the frequency of genotypes in patients after bariatric     surgery and (2) perform a preliminary evaluation of this research strategy. Our goal is to     identify genetic factors that may influence the success of various surgical weight loss     interventions and determine whether these factors are associated with specific patient     populations.   "
144266|NCT01396083|"     This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone     implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a     pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with     sham injections PRN afterwards.   "
144267|NCT01396070|"     The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an     investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically     mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options,     the treatments are associated with short response duration, thus this condition is largely     incurable. This investigational drug may offer less toxicity than standard treatments and     have better tumor specific targeting.   "
144268|NCT01396057|"     This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone     implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a     pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with     sham injections PRN afterwards.   "
144407|NCT01394237|"     The purpose of this study is to determine the long term results of laparoscopic     sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries     required, patients satisfaction and quality of life.   "
144296|NCT01395680|"     Family resilience is an important strength to help family to manage life challenge     successfully, and to reorganize family function. However, few studies have showed the     trajectory of family resilience in adolescents with cancer over time. The purposes of this     study are to know the trend of family resilience in adolescents with cancer from previous 3     months to the first year of newly diagnosed, and to examine the relationships among family     members' stress, family satisfaction, and family resilience in adolescents with cancer.   "
144269|NCT01396044|"     Medical errors account for tens of thousands of deaths and tens of billions of dollars in     healthcare costs in the United States every year. One field that has seen the strongest push     toward quality improvement has been critical care medicine, likely because its particularly     high degree of medical complexity makes it a practice area prone to high error rates with     serious consequences. One of the most commonly used interventions used to help reduce errors     in the intensive care unit (ICU) has been the implementation of checklists.      The investigators propose a clinical trial in a University critical care setting to determine     whether an electronic checklist versus verbal prompting to use a written checklist improves     clinical practice and patient outcomes. The investigators also plan to compare these data     with a time period prior to the study to determine if the electronic checklist or verbal     prompting are better than usual care. The investigators hypothesize that both the electronic     checklist and verbal prompting to use a written checklist will be better for clinical     practice and patient outcomes than usual care, and that verbal prompting will lead to better     outcomes compared to the electronic checklist.   "
144270|NCT01396031|"     Blood and marrow transplantation (BMT) is commonly used in the treatment of oncologic and     hematologic disorders. Patients undergoing Hematopoietic stem cell transplantation (HSCT) are     screened for functional status among other criteria to ensure that they are able to endure     the rigorous treatment involved during Hematopoietic stem cell transplantation (HSCT). The     patient entering the transplant process is possibly already functionally compromised from     their disease, prior cancer treatment, and possible other co-morbidities. Additional factors     of the transplantation that compromise the independent functional status of the patient     include the high dose preparative regimen, pancytopenia, steroid-related side effects,     hospitalization, transplantation complications such as infections, pulmonary alterations,     acute and chronic Graft-versus-host Disease (GVHD), pain, decreased nutritional input, and     other sequelae of transplantation.      Physical Therapy has been utilized in this population primarily as a supportive therapy to     prevent and limit the patient's functional decline. Studies have addressed general and     aerobic exercise in this population but there is a paucity of research investigating the     benefits of a strength-training program, particularly performed in weight-bearing, in     attenuating the detrimental effects of the transplantation on functional status.      This is a feasibility study questioning if an exercise program including weight-bearing     strengthening exercises and cardiovascular exercise is practical for the patients to carry     out as inpatients. The study will also preliminarily determine if this exercise program     influences functional outcomes and level of fatigue. Such outcome measures will include 1)     FiveTimes Sit-To-Stand Test, 2) Six-Minute Walk Test, 3) stair performance, 4) Functional     Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and Functional Assessment     of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scales.      The study population will include patients with lymphomas and acute leukemias undergoing     matched-related donor allogeneic myeloablative Blood and marrow transplantation (BMT).   "
144271|NCT01396005|"     In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will     be given boceprevir. Blood samples will be taken at specified intervals to find out whether     boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.   "
144272|NCT01395992|"     Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for     eligibility for this 26-week extension study in which they will continue treatment. The     primary purpose of this trial is to evaluate the long-term safety of asenapine.   "
144273|NCT01395979|"     Brief Summary: The specific aims of this study are:        1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing          therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in          HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual          abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse          (number and proportion) with serodiscordant partners. The investigators will also          examine the intervention effect on CSA-related trauma symptom severity and cognitions          and behaviors.        2. To examine the degree to which intervention-related reductions in sexual risk behavior          are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.        3. To examine the degree to which the intervention reduces incident sexually transmitted          infections (STIs) during the study period, as well as to explore additional potential          moderators and mediators of intervention efficacy.      Study hypotheses:        1. For the primary outcome, the investigators hypothesize that those who receive the          intervention will have reduced transmission-risk behavior.        2. For the secondary outcome, the investigators hypothesize that those who receive the          intervention will have reduced trauma symptom severity (cognitions and behaviors).   "
144274|NCT01395966|"     The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and     effective in treating middle ear infections in children with ear tubes.   "
144275|NCT01395953|"     The main objective of this exploratory 8 week pilot study is to evaluate the safety and     efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism     spectrum disorders. The study results will be used to generate hypotheses for a larger     randomized controlled clinical trial with explicit hypotheses and sufficient statistical     power.   "
144276|NCT01395940|"     The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with     endometriosis.   "
144277|NCT01395927|"     The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers     before and after the administration of multiple-doses of rifampin.   "
144278|NCT01395914|"     The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia     (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.   "
144279|NCT01395901|"     The primary objective of this study is to evaluate the efficacy of a single palonosetron IV     dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and     vomiting through 24 hours after surgery in children aged from neonates up to less than 17     years undergoing elective surgical procedures requiring general intravenous anesthesia. The     secondary objective is to evaluate the safety and tolerability of IV palonosetron in     pediatric patients.   "
144280|NCT01395888|"     This study is designed to evaluate the effect of fluticasone furoate (FF,     GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness     compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic     pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as     aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group,     multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the     randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment     period. There will be an approximate 7-day Follow-up period after the treatment period.   "
144408|NCT01394224|"     The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the     bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg     and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.   "
144281|NCT01395875|"     Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all     diagnosed COPD patients. Yet limited data exists on characterizing this study population in     terms of drug therapy patterns and COPD-related resource use and costs. The objective of the     following study was to conduct an analysis in the real-world setting to (1) identify and     characterize COPD patients with moderate exacerbations and (2) evaluate the impact of     initiating different maintenance therapies in this population. Maintenance therapy     medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs),     combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and     ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium     [IPR]).   "
144282|NCT01395862|"     The purpose of this study is to detect adverse drug reactions for long-term use (particularly     clinically significant adverse drug reactions) occurring in clinical settings, to examine     factors likely to affect the safety and efficacy in the Japanese asthma patients who are     treated with fluticasone propionate/salmeterol xinafoate.   "
144283|NCT01395849|"     The purpose of this post-marketing surveillance is to detect adverse drug reactions     (particularly clinically significant adverse drug reactions) occurring in clinical settings,     to examine factors likely to affect the safety and efficacy in the Japanese asthma patients     treated with fluticasone propionate and salmeterol xinafoate.   "
144284|NCT01395836|"     One common occurrence following open heart surgery is an irregular rhythm from the top     chambers of the heart known as atrial fibrillation (afib or AF). It is known that about 30%     of patients who have had bypass surgery without having a heart valve replaced at the same     time will develop AF. It is felt that this occurrence leads to factors that will affect a     subjects health for the rest of their life. In studying this the investigators will see if     post operative afib is an indicator of a person having afib and is not a condition that may     only last during the post op recovery period as many physicians feel.The problem in question     is, is post operative afib only transient or is it an indicator for more long term episodes     of afib that may lead to other health concerns like stroke. Fifty subjects will be asked to     participate. There will be to groups of 25 subjects. All subjects will have a device     implanted under the skin that will be able to detect all types of heart rhythms. One group     will get standard treatment and the physicians will be blinded to the recordings. The other     group will be treated by the recording and the information about the amount of time in afib.     The purpose of the study is to determine what the true occurrence of afib is for the first     year after open heart surgery and to see if knowing this will alter the clinical management     of this group of subjects.Currently most subjects are treated without knowing this     information and based on that the arrhythmia will no longer happen after the heart is healed     or recovered from the surgery. Most medications for controlling the heart rate and rhythm are     stopped around 3 months. There is also a tendency to not to use blood thinning medications     for the prevention of stroke after this time period. Stroke is one of the major complications     from afib. Not all subjects are aware of the irregular heart beats so you can not depend on     them to accurately know. They might feel episodes of very fast beating episodes or may become     weak and fatigued. Weakness and fatigue are also normal during the first parts of recover     from bypass surgery. By documenting the true episodes of afib the investigators can better     understand if postoperative afib might need to be treated as a life long issue rather than a     transient post operative issue. This treatment might change clinical management and decrease     mortality.   "
144285|NCT01395823|"     A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D     supplementation, but only one of these is a prospective clinical trial, and it is a small,     single center study lacking a control arm. The investigators propose to conduct a double     blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to     confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and     mineral metabolic parameters in hemodialysis patients.   "
144286|NCT01395810|"     This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to     evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term     exposure in patients with haemophilia B.      This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773     (NCT01386528/paradigm™ 3).   "
144287|NCT01395797|"     The goal of the proposed research is to improve the effectiveness of treatments for opioid     and for nicotine dependence by testing a novel pharmacological strategy. Specifically,     pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be     used as an adjunct to agonist-based treatment.   "
144288|NCT01395784|"     The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been     characterized in a controlled laboratory setting. Accordingly, the proposed investigation     seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused     opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this     investigation is to characterize the subjective effects of oxycodone under maintenance on     various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers.     Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive,     and physiological effects of oxycodone.   "
144289|NCT01395771|"     The adherence rate (95%) to HAART in the intervention group which receives a phone call will     be higher than that(75%)of control group which does not receive a phone call.   "
144290|NCT01395758|"     The purpose of this study is to evaluate progression-free survival among subjects with KRAS     mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib     (ARQ 197) compared to single agent chemotherapy.   "
144291|NCT01395745|"     The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod     administered in addition to standard therapy in subjects with active Systemic Lupus     Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable     corticosteroid therapy.   "
144292|NCT01395732|"     The effect of bosentan on digital ulcers (DU) was studied in two randomized     placebo-controlled trials (RAPIDS-1 and RAPIDS-2). A limitation of these studies was the     heterogeneous study population. More importantly, there were no endpoints that assessed     changes in vasculopathy and / or perfusion. Laser Doppler imaging has been shown to     effectively demonstrate blood flow restrictions in the hands of patients with Systemic     Sclerosis (SSc). The relation between blood flow restriction in the hands measured by laser     Doppler imaging and the extent of DU disease has not been studied. The current study will     attempt to demonstrate this relation. In addition, the impact of bosentan on the blood flow     in the hands, in a defined cohort of SSc-DU patients with a history of DU within the past 2     years and a clinically relevant reduction of blood flow in the hands, will be assessed.   "
144293|NCT01395719|"     The purpose of this study is to determine whether remote ischemic conditioning can improve     the outcome after renal transplantation with deceased donor. Remote ischemic conditioning is     performed on the patient receiving a kidney from a deceased donor. Remote ischemic     conditioning is done during the operation by inflating a tourniquet on the patients leg     before opening the blood circulation to the kidney. The study focus on both the immediate     kidney function after the transplantation, but also on the extended kidney function one year     after the transplantation.   "
144297|NCT01395667|"     In this phase I trial neoadjuvant CCRT combining IMRT with three escalated dose levels (45     Gy, 50 Gy, and 55 Gy in 25 fractions) and BV-fluorouracil/ leucovorin/oxaliplatin (FOLFOX)     regimens is planned for 15 locally advanced rectal cancer patients. The primary goal is to     define the maximally tolerated dose of radiotherapy and the treatment related acute toxicity,     and to demonstrate that preoperative highly conformal IMRT and concurrent BV-chemotherapy     will lead to acceptable acute gastrointestinal morbidity. The secondary goal is to     demonstrate that this treatment modality will elicit a comparable or improved rate of T stage     downstaging and complete response pathologically.   "
144298|NCT01395654|"     Despite the availability of effective anti-tuberculosis agents that exist to treat this     illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as     isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use.     There is no consensus on method of the reintroduction of anti-TB medications. The risk of     reintroducing of a anti-TB medications could be hazardous. There are several differences     between the guidelines from the ATS, BTS and the Task Force of the European Respiratory     Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the     methods of reintroducing of anti-TB medications.      The investigators plan to do a prospective study to evaluate the outcome and safety of     reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment     among TB patients in the investigators hospital.   "
144299|NCT01395641|"     This Phase I/II trial is to prove the efficacy and safety of AAV2-hAADC to treat patients     with AADC deficiency.   "
144300|NCT01395628|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about cancer and the development of drug resistance in patients.     It may also help doctors find better ways to treat cancer.      PURPOSE: This research trial is studying samples from patients with leukemia.   "
144301|NCT01395615|"     This observational study will assess the health related quality of life (HQRL) profiles of     patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data     will be collected from patients currently receiving therapy and from those who have finished     therapy and have undergone an assessment of treatment.   "
144302|NCT01395602|"     The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine     receptor agonist, on body weight and blood glucose in healthy obese adults.      This is a randomized double-blind placebo controlled study. Twenty subjects each will be     randomly assigned either placebo or cabergoline for 16 weeks.      The effect of treatment on body weight and blood glucose and insulin levels will be compared     in the treatment versus the placebo arm.   "
144303|NCT01395589|"     Asthma is a major health problem affecting 22 million in the USA and 300 million people     worldwide.      Recently vitamin D was identified as a possible co-factor and found that low vitamin D was     associated with increased steroid use. In Qatar the prevalence of vitamin D deficiency among     health care professionals was reported as high as 87% and 68.8% among school children.      In 1 year prospective study of patient with vitamin D and moderate -severe asthma will be     followed after slow versus fast correction for asthma control.      This is randomized clinical trial study. INCLUSION CRITERIA: Children 2-14 years of age with     moderate to severe asthma and proved to be Vitamin D deficient by serum level will be     included in this study.      EXCLUSION CRITERIA: Prematurity (Gestational age 34 weeks or less),Patients on vitamin D     therapy,Patients on seizure medication or diuretics,Patients on chronic steroid use for other     reasons than asthma,Patient with chronic liver or kidney disease,Patients with inherited bone     disease,Patients with hypo or hyper parathyroidism,patients with history of chronic lung     disease other than asthma Methodology:- On arrival, patients with asthma with exacerbation     will be assessed by the emergency staff. Children aged 2-14 years admitted to the     inpatient/short stay unit for the treatment of moderate-severe asthma, meeting inclusion and     exclusion criteria will be eligible for the study.      Guardians of eligible patients will be approached regarding the study, explaining the purpose     and the treatment modalities. Patients will be included after obtaining a verbal consent.      All patients will be treated as usual. Blood sample for 25OH cholecalciferol level will be     sent before discharge. Patients with vitamin D deficiency will be called to receive either     daily oral vitamin D or single injection of intramuscular vitamin D and level of vitamin D     will be repeated at 3,6,12 months. Followed up will continue for 1 year with a structured     phone call interview by a research assistant at the first week of each month filling the     survey for the previous month.      Ethical Considerations: Informed consent will be obtained from the guardian.      Sample Size:      a total of 105 patients will be recruited under this study. Statistical Analysis:- Univariate     and multivariate analysis will be performed as required. Cox proportional hazards model will     be used to compare the two treatment groups.   "
144304|NCT01395576|"     Post stroke patients often suffer from decrease in strength, loss of balance and gait     asymmetry. Accordingly, these patients are at high risk for falls and fall-related injury.     The presence of spastic or retracted muscles, e.g. the ankle plantar flexors or the     quadriceps in combination with hamstrings weakness, causes knee hyperextension, which     increases the stance phase duration and makes it difficult to achieve symmetrical gait.     Additionally, this gait disorder can be painful as a result of stress to the ligaments and     tendons at the posterior aspect of the knee.      The Genu Neurexa orthosis is designed to stabilize the knee, enable balance control and     prevent hyperextension. In order to assess the effect of the orthosis on the gait and balance     characteristics of stroke patients the investigators will conduct subjective patient's     satisfactory questionnaire, complete physical and functional evaluation and gait analysis, as     well as dynamic electromyography (EMG) muscle activation patterns. These examinations will be     performed 3 times: at the beginning of the trial, after one month and after two months. The     trial design is explained in the following paragraph.      The investigators hypothesize that the gait pattern will be improved while using the knee     orthosis,as will be expressed by smaller base width and faster walking velocity etc.   "
144305|NCT01395563|"     The purpose of this study is to determine whether prednisone, methotrexate, and     cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both     ears due to autoimmune inner ear disease (AIED).   "
144306|NCT01395550|"     AstraZeneca was interested in knowing how Cardiologists and Physicians treat patients who     have suffered a cardiovascular event.   "
144741|NCT01389843|"     KorAHF is a multi-center registry (prospective cohort) for acute decompensated heart failure     patients in Korea.      The aim of this registry is to analyze several causes affecting prognosis and survival and to     develop new strategies for managing acute decompensated heart failure.   "
144307|NCT01395537|"     RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent     for the treatment of esophageal and GEJ tumors.      PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in     combination with capecitabine or letrozole. It is hoped that by giving lapatinib and     carboplatin and paclitaxel together, their combined effects will further slow or stop the     cancer cells from growing.   "
144309|NCT01395511|"     The purpose of this study is to determine whether acupuncture is effective and safe     therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and     discomfort due to Whiplash associated disorder. (Traumatic car accidents)      We recruit 40 participants who had cervical, shoulder and upper extremity pain and had     discomfort due to Whiplash associated disorder. And then we check initial data of 40     participants (Pain;VAS, Cervical ROM, SF-36, SDS, CMI)      40 participants were randomly allocated to two groups ; acupuncture group or waiting-list     group.      Acupuncture group: participants were given acupuncture treatment three times a week during 2     weeks, for 15 minutes at each session. After 6 times acupuncture treatments, we check     information of participants again after 2 weeks(VAS, ROM, SF-36, SDS, CMI)      Waiting-list group : The waiting-list group did not receive acupuncture treatment. After 2     weeks we check information of participants again (VAS, ROM, SF-36, SDS, CMI)      The waiting-Patients in both groups were permitted to receive usual care including physical     therapy and exercise and were not permitted to take analgesics and antiphlogistics during the     trial periods.   "
144310|NCT01395498|"     The purpose of this study is to determine the incidence of the carriage state (asymptomatic     colonization) with Pneumocystis Jirovecii (Pneumocystic Carinii Pneumonia, PCP) and     Cytomegalovirus (CMV)in the human lung. These are pathogens causing pneumonia in patients     with suppressed immune system, but not known to cause disease in otherwise normal people. The     investigators hypothesis is that a carriage state exists for these two pathogens. To test     this hypothesis the investigators will examine bronchoalveolar lavage fluid for genetic     material of these two pathogens. The study population will be patients undergoing fiberoptic     bronchoscopy and lavage for indications other than diagnosis of a presumed opportunistic     infection.   "
144311|NCT01395485|"     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in     adolescent and adult subjects with intermittent or mild to moderate persistent asthma.   "
144312|NCT01395472|"     The aim of this study is to determine the effects of an acute session of physical exercise on     cognitive functioning and humor of traumatic brain injury patients and to investigate whether     different cognitive responses can be achieved with different intensities of exercise     (moderate and vigorous).      The investigators hypothesize that while moderate intensity physical exercise may be     beneficial to cognitive functioning, vigorous intensity may be detrimental to TBI patients,     as physical fatigue may impair alertness and other higher cognitive functions.   "
144313|NCT01395459|"     Parent study:      A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of     two intervention arms (described below) intended to increase breast, cervical, and colon     cancer screening rates among patients served by community health centers. A central focus of     CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among     populations facing significant cancer disparities.      CATCH was conducted in partnership with the large health clinic in Massachusetts, which     serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice     Response (IVR) telephone technology system, the study is examining the extent to which the     IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be     conducted to inform the intervention), can improve breast, cervical and colon cancer     screening rates compared to a control group. Furthermore, we plan to determine if pairing IVR     with telephone calls from a prevention care coordinator (PCC) will result in higher screening     rates (when compared to the IVR only group). We will determine the cost-effectiveness of IVR     alone vs. IVR + PCC.      Substudy:      We conducted a substudy of the parent study, looking at a comparison of return rates of two     colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal     Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types of     tests to assess barriers and facilitators of returning the completed kit to the health center     for assessment.   "
144314|NCT01395446|"     The purpose of this study is to establish the accuracy with which the eNose can discriminate     patients with invasive pulmonary aspergillosis from controls.   "
144315|NCT01395433|"     This is a bioequivalence study, which is a regulatory requirement to ensure comparable in     vivo performance, i.e. similarities in terms of safety and efficacy, after administration of     two different dosage forms of escitalopram.      All subjects will receive three separate dosages of 20 mg escitalopram, which are 2 x 10 mg     of the conventional dosage form (Treatment A) and 2 x 10 mg of the new dosage form being     tested (Treatment B) and 1 x 20 mg of the new dosage form being tested (Treatment C). Test     treatments B and C will each be compared to Treatment A, which is the active comparator     (reference formulation).   "
144338|NCT01395134|"     Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy     results in lowered fundamental frequency of the voice and worsened voice performance in     producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring     (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice     performance. This study was designed to test that hypothesis.   "
144339|NCT01395121|"     The aim of this study is to see if a drug called nilotinib (Tasigna®) is effective in the     treatment of patients with a rare group of acral and mucosal melanomas that have a change     (mutation) in a protein called cKIT. Nilotinib interferes with signalling inside cells with     this mutation and it is believed that this may lead to shrinkage of tumours. Acral melanomas     are found on the palms and soles and mucosal melanomas start inside body cavities rather than     on the skin.   "
144340|NCT01395108|"     The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in     healthy Chinese volunteers.   "
144342|NCT01395082|"     The purpose of this registry is to study the natural history of vaccination-related     myocarditis and pericarditis and to assess possible risk factors for these conditions.      Primary Objective:      - To document the natural history of confirmed, probable, suspected, and subclinical     myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.      Other Pre-defined Objective:      - To look for potential predictive factors for the prognosis of myopericarditis following     ACAM2000® vaccination.   "
144343|NCT01395069|"     Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing     macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and     randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular     coherence tomography (OCT).   "
144317|NCT01395407|"     Brain metastases are the most common adult intracranial tumor, occurring in approximately 10%     to 30% of adult cancer patients, and represent an important cause of morbidity and mortality     in this population. The standard of care for solitary brain metastasis is surgery followed by     whole brain radiation therapy (WBRT). Without WBRT, there are unacceptably high levels of     local failure that occur. Local recurrence rates ranged from approximately 45% at 1 year to     60% at 2 years after resection alone. However, aside from improvements in intra-cranial     control, it is well documented that WBRT is associated with serious long term side effects,     including significant decline in short term recall by as early as 4 months after treatment.      Many centers are now offering patients stereotactic radiosurgery (SRS) to the cavity after     resection alone to improve local control while avoiding the negative effects of WBRT. There     have been several retrospective studies on the use of SRS to the resection cavity alone, from     which the 1 year actuarial local control rates range from 35% - 82%. The high rate of     in-field local failure suggests that the current dosing regimen used may not be high enough     for adequate local control. Currently, the highest local control rates are approximately 80%,     but there may be room for improvement with increased dose without significantly increasing     the risk of side effects.      The investigators propose a trial for patients after surgical resection of solitary brain     metastases. The purpose of this trial will be to determine the maximum tolerated dose for     single fraction SRS to the resection cavity. There will be three groups based on the     resection cavity size. Dose escalation enrollment will be done sequentially within each     cohort. You will know which cohort and which specific dose level you are randomized to. After     treatment, which will take one day, regardless of cohort, you will be followed closely for     treatment outcome and possible side effects. You will be asked to complete three quick     surveys at each follow-up appointment regarding quality of life and memory in addition to     standard of care surveillance brain MRI and physical exam.   "
144318|NCT01395394|"     The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as     sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial     function in patients with Phenylketonuria (PKU).   "
144319|NCT01395381|"     The benefit of anti-worm therapy as part of the case management of severe acute malnutrition     (SAM) in the outpatient setting has not previously been studied. This study will compare     recovery rates of children with SAM treated in the community with locally-produced     ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their     case management.   "
144320|NCT01395368|"     Tinnitus, commonly referred to as ringing in the ears, affects 50 million people in the     United States and is recognized as a major public health concern. Tinnitus is the most     frequent cause of service-connected disability claims among war veterans. Tinnitus remains a     subjectively diagnosed entity. There is no standardized objective method of diagnosing     tinnitus or describing the functional impact of the condition. Currently, physicians have to     rely on patient-based self reports. Without an objective method of diagnosing tinnitus and     describing the functional implications, adequate treatment delivery is also hampered since     there is no way to objectively stratify patients into severity groups and assess response to     treatment. Because tinnitus is known to negatively affect cognition through the ventral     attention networks and the prefrontal cortex, measuring cognitive processing speed is a     possible way to objectively measure tinnitus. This study builds on previous work the     investigators have done that utilized a quick, easily accessible measure of auditory     processing speed. That earlier study showed a correlation between that measure and self     reported measures of tinnitus severity, and this study attempts determine a more precise     estimate of that correlation. It also better validates those results by including a     traditional neurocognitive measuring cognitive speed and by controlling for the presence of     depression and somatoform disorders.   "
144321|NCT01395355|"     This study aims to develop a manualized and culturally sensitive intervention for adolescent     girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the     feasibility and acceptability of the intervention in a controlled pilot trial. The     investigators hypothesize that this intervention will serve to reduce binge and LOC eating,     as well as improve psychosocial functioning as evidenced by decreased depression, anxiety,     eating disorder cognitions, and impulsivity, and improved quality of life.   "
144322|NCT01395342|"     Introduction:      Hypertensive disorders during pregnancy are an important issue in global public health. It is     current the leading cause of maternal mortality in Brazil.      Objective:      To assess the effect of physical exercise using stationary bicycle through blood pressure and     heart rate measurements, incidence of pre-eclampsia and quality of life survey in pregnant     women with chronic high blood pressure, previous preeclampsia pregnancies or both factors     associated comparing to a group with no intervention. Verify the type of births, maternal and     perinatal outcomes in both groups. Methodology: This randomized clinical trial enrolled     pregnant women presenting chronic hih blood pressure, previous pre-eclampsia experience or     both. Women from 12 to 20 gestational weeks were selected from the prenatal outpatient clinic     and randomly allocated to the study or non-interventional group. Women at the study group     performed physical exercise using stationary bicycle (horizontal bench model) during 20     minutes, once a week. The heart rate was maintained at 20% above resting heart rate and up to     140 bpm. Blood pressure and heart rate measurements were evaluated before and after exercise.     The non-intervention group followed regular prenatal routine with weekly returns for heart     rate and blood pressure measurements. Both groups fulfilled the quality of life survey (SF-36     questionnaire) at three times: between 12 and 20 weeks; 28 and 32 weeks and 36 and 41 weeks     of gestation. After that data of parturition will be analyzed to compare the incidence of     pre-eclampsia, types of birth, maternal and perinatal outcomes.   "
144323|NCT01395329|"     The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone     in adult humans with elevated blood pressure to a greater extent than either metoprolol or     placebo.   "
144324|NCT01395316|"     The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to     protect the brain from inflammation and how it may enhance repair through remyelination.   "
144325|NCT01395303|"     Polymorphisms in the vitamin D system appear to affect the serum 25(OH)D levels. If so one     would expect these polymorphisms to be associated with vitamin D related conditions and     diseases, which will be tested in the present study including DNA analyses in 9700 subjects   "
144326|NCT01395290|"     There are indications that the vitamin D status of an individual is related to susceptibility     to staphylococcal infections. In the present study we will examine nasal colonisation rate in     subjects participating in an ongoing vitamin D intervention study ( 20.000 IU cholecalciferol     per week vs placebo) for the prevention of type 2 diabetes in subjects with impaired glucose     tolerance.   "
144341|NCT01395095|"     The objective is to investigate whether in acute coronary syndrome patients the cardiac risk     profile will improve with 2 new extended cardiac rehabilitation interventions and if these     patients maintain healthier life style habits and a more active life style compared to     patients randomized to standard cardiac rehabilitation.   "
144327|NCT01395277|"     Groups of naturally occurring compounds called flavonoids are found in foods such as fruits     and vegetables, red wine, tea, dark chocolate and cocoa products. Diets rich in flavonoids     are associated with decreased risk for cardiovascular disease and major cardiovascular events     (i.e. myocardial infarction) and have been shown to improve blood pressure, insulin     sensitivity, and vascular function in a variety populations (Type II diabetes, elderly,     smokers, etc.). The presumed beneficial effects of these compounds are thought to act through     their inherent ability to scavenge free radicals. Specifically flavonoids scavenge superoxide     anions which are free radicals that react with nitric oxide (NO) to produce peroxynitrite.     The formation of peroxynitrite ultimately reduces the bioavailability of NO which is     essential for vasodilation and thus vascular health and function. Normal aging is associated     with impaired endothelial function, which presumably is due to less than optimal levels of NO     bioavailability. Therefore, interventions that can increase NO bioavailability would be     expected to improve microvascular function and vascular health in this population. The     purpose of this study is to investigate the effects of dietary flavonoid supplementation on     the vasodilatory capacity of the cutaneous vasculature, as well as on cerebral vascular     reactivity and arterial stiffness in young and old humans. This study will test the     hypothesis that acute dietary flavonoid treatment will improve impaired cutaneous     vasodilatory capacity, cerebral vasomotor reactivity, and reduce arterial stiffness in older     but not young humans.   "
144328|NCT01395264|"     Migraine is one of the commonest neurological disorders, affecting up to 12% of the general     population, but remains relatively under-diagnosed and under-treated. Migraine has a wide     socioeconomic impact and brings a large economic burden; estimates suggest that disability     due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and     impact, migraine pathophysiology is poorly understood. A wider understanding of the     functional changes in this disorder would be beneficial to both diagnosis and treatment.      Saccades are the rapid eye movements we make when moving the eyes to a new object in our     visual field. Reaction time studies have been used to investigate Huntington's disease and     Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements).     Even at rest we make approximately three saccades per second, so a lot of data can quickly be     gathered with non-invasive testing. We hope to understand more of the underlying mechanisms     of migraine by studying reaction time in migraine patients.      Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at     fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed     significantly different saccadic patterns to non-migraineurs.      This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study     in a group of migraineurs, and secondly to explore the specificity of these findings in     migraine by also studying patients with another primary headache syndrome, namely cluster     headache.      Migraine is known to be a dynamic disorder, with previous studies showing longitudinal     changes in the migraine brain. To explore this further we hope to record longitudinally     (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal     changes in saccadic reaction time. Because of the portability of the equipment this could be     done in the subjects own home if they preferred.   "
144329|NCT01395251|"     Rheumatoid arthritis is an inflammatory joint disease often leading to progressive joint     destruction. To prevent disability caused by inflamed joints early diagnosis is important.     Early diagnosis might be a challenge because the diagnosis is mostly based on clinical signs     like swelling of small joints. In clinical practice a therapy with prednisolone is started     although the patients do not have an exact diagnosis. In this cases the prednisolone might     serve as a diagnostic test for an inflammatory process.      The objective of this study is to investigate the diagnostic value of oral prednisolone test     for rheumatoid arthritis.   "
144330|NCT01395238|"     This study focuses on the development of the Fathers Supporting Success in Preschoolers     (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading     to engage fathers in and improve parenting and child behavior.   "
144331|NCT01395225|"     When the bladder is removed for bladder cancer, pelvic lymph nodes (LN) are also removed.     While the anatomic extent of this LN dissection is critical, the investigators often use the     number of LN removed as a measure of the extent, which in turn is essential for determining     the patient's further treatment and prognosis. The LN count, however, is also dependent on     the pathologist's processing of the LN tissue, and the standards for this processing are     poorly defined. The goal of this study is to establish a standardized method for processing     and analyzing lymph node specimens. The investigators hypothesize that if an organic solvent     is used to remove excess fat from the lymph nodes that the investigators will discover more     clinically significant nodes in a more reproducible fashion when compared to the current     method.   "
144332|NCT01395212|"     The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined     (intramyocardial and intracoronary) delivery of autologous BM-MNCs.      The clinical endpoint of this prospective non-randomized observational study is the MACCE,     defined as major adverse cardiac and cerebrovascular events. Patients will be investigated by     echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging will     refine the evaluation with more exact analysis of the intramyocardial injected areas (ROI).   "
144333|NCT01395199|"     This study aims to investigate the use of amlodipine, a drug that blocks the uptake of     calcium into cells, in the prevention and treatment of iron overload in patients with     thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and     other organs, blocking these channels might help to prevent the accumulation of iron in these     tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine     and 30 will serve as controls receiving placebo in a randomized double-blind fashion.     Patients will be monitored through one year. Monitoring will occur through the measurement of     blood ferritin as well as live and heart T2* by MRI initially, at 6 and 12 months.   "
144334|NCT01395186|"     there are many studies studying the effectiveness of surgical treatment in patients treated     for infertility, but only a few reporting the results of varicocelectomy done for pain. This     study attempted to examine the success rate of varicocele ligation when performed for the     treatment of pain and to evaluate all the predictor factors that may affect the pain resolve   "
144335|NCT01395173|"     The purpose of this study is to determine whether position changes during colonoscope     withdrawal affects polyp detection rate. We hypothesize that positions change during scope     withdrawal will increase polyp detection rate.   "
144336|NCT01395160|"     The Female Experiences and Brain Activity study will investigate how different groups of     people process information in different ways. Using electro-physiological methods it will     investigate differences in brain activity between women with ADHD, women with bipolar     disorder and those without a psychiatric illness. It will also investigate the relationship     between patterns of brain activity, mood and functioning.   "
144345|NCT01395043|"     Major abdominal surgery is associated with postoperative pain. Transversus Abdominis     Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal     surgery. However a single block has a short effect of up to 12 hours depending on the type     local-anesthetics used.      With this study we wish to investigate the possibilities to place a TAP-catheter in order to     prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP     catheter and to study the pain and the opioid requirements of patients undergoing elective     colon-resection when given a TAP-catheter preoperatively.      Our hypothesis is that it is practical and technical possible to place bilateral     TAP-catheters pre-operatively and that pain and opioid-requirements will be low.   "
144346|NCT01395030|"     Altered choline phospholipid metabolism is a recently recognized hallmark of cancer and     potential diagnostic and therapeutic target in a number of cancers, including hepatocellular     carcinoma (HCC). The feasibility of detecting HCC on the basis of measuring the     phosphorylation rate of choline in-vivo has been shown using positron emission     tomography/computed tomography (PET/CT) and the investigational tracer compound [18F]     fluorocholine (FCH). This Phase 2 study will evaluate the diagnostic performance of FCH     PET/CT in patients undergoing surgical resection as treatment for HCC. Since the molecular     signaling alterations leading to enhanced choline metabolism in tumors are not fully     elucidated at this time, this study will also collect frozen tissue specimens for     whole-genome gene expression profiling to elucidate genes and signal transduction pathways     related to altered choline metabolism in HCC.   "
144347|NCT01395017|"     The purpose of this study is to determine whether patients with locally advanced pancreatic     cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to     patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.   "
144348|NCT01395004|"     The purpose of this study is to assess safety and efficacy at months 3 and 6 in patients with     Langerhans Cell Histiocytosis given daily oral doses of GSK2110183.   "
144349|NCT01394991|"     The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer     who have chemotherapy-related anemia.   "
144350|NCT01394978|"     The purpose of this post approval study is to further characterize the safety profile of the     ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term     safety over 90 days of follow-up.   "
144351|NCT01394965|"     The purpose of this study is to evaluate a novel non-invasive cardiac electric imaging     methodology for localizing and imaging cardiac electrical activity from body surface     electrocardiographic recordings in patients with ventricular tachycardia (VT). Using     non-invasive means will increase our ability to correctly diagnose cardiac abnormalities, and     aid ablation of cardiac arrhythmias, offering enhanced performance to what currently exists.   "
144352|NCT01394952|"     The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular     events and other serious outcomes in persons with type 2 diabetes, when added to their     anti-hyperglycemic regimen.   "
144353|NCT01394939|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594     (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in     colorectal carcinoma patients who are refractory to or intolerant to standard therapy.   "
144354|NCT01394926|"     The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL,     0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries     when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.   "
144355|NCT01394913|"     This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT®     versus ENBREL®) for treatment of Rheumatoid Arthritis.   "
144356|NCT01394900|"     The study has the following primary aims: (1) to test whether participants assigned to CNU (a     7-session, manualized intervention entitled Connect 'n Unite) engage in lower HIV/STI     behavioral risk compared to participants assigned to WP (a wellness promotion attention     control condition); (2) to test whether participants assigned to CNU have lower cumulative     incidence of STIs—chlamydia and gonorrhea—confirmed via biological assay compared to     participants assigned to WP; and (3) to test whether participants assigned to CNU engage in     less drug use compared to participants assigned to WP.   "
144357|NCT01394887|"     Hypothesis. To determine the effect of metformin on the concentrations of resistin and other     insulin resistance or inflammatory markers (C-reactive protein, cytokines, body weight,     HbA1c, among others) in minors with glucose intolerance.      Children with glucose intolerance are given either metformin or placebo for 12 consecutive     weeks.      High sensitivity C-reactive protein, TNF-alpha, IL-6, IL1-beta, resistin, leptin,     adiponectin, glucose, insulin, HbA1c, lipid profile and transaminases are measured at the     beginning and at the end of the period. Statistical analysis: t Student test; Friedman and     Kruskal Wallis test are used. Variables are adjusted for: sex, age, baseline BMI and     percentage weight change.   "
144358|NCT01394874|"     The purpose of this intervention is to determine whether computer-based telephone counseling     will improve adherence to strength training in a population of elders with knee     osteoarthritis.   "
144359|NCT01394861|"     The purpose of this study is to evaluate the feasibility, ease and safety of flexible     endoscopic robotic system to treat early gastric cancer in humans.   "
144390|NCT01394458|"     Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are     locked into hemodialysis catheters between dialysis sessions to prevent thrombosis. The use     of an ethanol/sodium citrate locking solution may have advantages over either of these agents     alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking     solution is safe and effective in the prevention of catheter-related infections and     thrombosis.   "
144391|NCT01394445|"     The investigators hypothesize that the administration of physostigmine in the postoperative     period after nephrectomy reduces opioid consumption.   "
144392|NCT01394432|"     The investigators hypothesised that endocardial stem cells implantation following after     percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse     remodeling in patients with primary acute myocardial infarction.   "
144393|NCT01394419|"     N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump     coronary artery bypass graft.   "
144360|NCT01394848|"     Thanks to rapid reendothelialization derived from the pro-healing property of the EPC capture     stent, 1-month dual antiplatelet therapy (DAPT) is recommended after EPC capture stent     implantation. Shorter maintenance of dual antiplatelet therapy might minimize the risk for     stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent wasteful     medications and bleeding complications related with dual antiplatelet therapy. Thus, the EPC     capture stent might be valuable for the elderly because they are vulnerable to premature     discontinuation of DAPT.      On the other hand, statin upstream therapy has gained popularity because it seems to reduce     periprocedural myocardial injury especially in ACS through its pleiotrophic effect like     plaque stabilization. However, the benefit of pretreatment of statin in patients with stable     angina remains controversial. It is reported that statin administration could increase EPC     level by accelerated differentiation towards the endothelial progenitor lineage.      We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is     non-inferior to DES in the elderly subjects with stable coronary artery disease. To test this     hypothesis, we will perform a multi-center, randomized, prospective trial aimed at     demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES     with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in     real world practice.   "
144361|NCT01394835|"     Bronchiolitis obliterable syndrome (BOS) is the most common cause of death in long-term     survivors after lung transplantation and refractory to most interventions. Many risk factor     for BOS were identified in previous studies such as acute cellular rejection, lymphocytic     bronchiolitis, cytomegalovirus (CMV) and non-CMV respiratory infections, injury to the     allograft or airways, Primary graft dysfunction, HLA mismatching, and organizing pneumonia.     (Belperio JA. et al.). Neutrophils and their released products may be involved in the     development of BOS. Neutrophilia was repeatedly observed in the bronchoalveolar lavage fluid     of patients after lung transplantation. In addition, infiltration of neutrophils into the     bronchial epithelium has been detected in patients with higher degrees of active airway     damage. Neutrophils are capable of causing severe damage to the lung tissue by releasing     toxic proteases and reactive oxygen species if not counterbalanced by the antiprotease/     antioxidant screen of the lung. Based on this background, a causal relationship between     neutrophilia and the development of BOS has been proposed. (Hirsch J. et al.) Detection of     unopposed Neutrophile elastase (NE) activity in BAL appears to correlate with poor outcome     due to refractory BOS. Unopposed NE in these subjects may not only serve as a marker of     evolving graft dysfunction but also participate in damaging the airways of the allograft and     inhibit adequate bacterial clearance. Prevention of neutrophil sequestration or inhibition of     NE may prevent or attenuate airway damage and improve bacterial clearance mechanisms. (Nutley     D et al.) These data demonstrate the importance of neutrophils and unopposed NE in the     pathogenesis of BOS and call for new approach to prevent or modulate BOS targeting this     mechanism.      AAT is the main inhibitor of neutrophil elastase in the lower airways and patients with AAT     deficiency have low concentrations of the protein in this region of the lung. This explains     the proteinase/antiproteinase theory of the development of emphysema in deficient patients in     which the amount of elastase released in the lung exceeds the amount of AAT. The net result     is persistence of elastase activity leading to lung destruction and the pathological changes     of emphysema. (Abusriwil H. et al.) The administration of the AAT is to address     proteinase/antiproteinase imbalance.      Administration of AAT will help to prevent further destruction of the lung architecture and     reduce the inflammatory dysregulation that causes pulmonary dysfunction. It is expected that     by attacking a specific and previously untreated key component part of the pathophysiological     cycle of BOS, AAT therapy would decrease the prevalence of BOS in lung transplant recipients     and prolong life expectancy of these patients.   "
144362|NCT01394822|"     The purpose of this study is to determine if a new diagnostic technique, called neuromuscular     ultrasound, can improve our ability to diagnose focal nerve disease.   "
144363|NCT01394809|"     The therapy results after distal radius fracture especially of elderly patients are often     suboptimal. The central problem results from the inevitable, 3-6-weeks immobilization, which     leads to reduction in ROM of the wrist, deterioration of muscle strength as well as     malfunction of fine motor skills and coordination. Currently, there are no adequate proactive     strategies to counteract these immobilisation problems. Hence the overall aim of our research     project is to investigate the therapeutic potential of a motor-cognitive therapy on hand     function after distal radius fracture. On the one hand the pilot study should provide     information about the level of recruitment rate necessitated for an adequate sample size     which allows reliable evidence for the therapy effects. On the other hand we want to evaluate     the sensitivity and adequacy of the assessment instruments.      The pilot is conceived as a controlled, randomised, longitudinal intervention study over 6     weeks with 3 groups. One experimental group imagine movements and actions without executing     them. A second experimental group performs mirror training, in which visual feedback through     a mirror activates additionally the contralateral hemisphere. The control group receives     therapy as usual. There are three key domains to be analysed: function (PRWE), impairment     (ROM, strength) and participation in social life/life quality (DASH, EQ5D).   "
144364|NCT01394796|"     There is a mounting evidence of the modulation properties of the major catechin in green tea,     epigallocatechin-3-gallate (EGCG), on dual specificity tyrosine-phosphorylation-regulated     kinase 1A (DYRK1A) gene overexpression in the brains of DS mouse models.The aims are to     investigate the clinical benefits and safety of EGCG administration in young adults with DS,     to establish short-term EGCG effects (three months) on neurocognitive performance, and to     determine the persistency or reversibility of EGCG related effects after three months of     discontinued use.   "
144365|NCT01394783|"     Every year thousands of neonates born in North America need extensive resuscitation which     often includes endotracheal intubation (ETI). In these situations, Pediatricians assume the     role of Neonatal Resuscitation Program (NRP) providers and are responsible of the ETI     procedure. They acquire this skill during residency training in the Neonatal Intensive Care     Unit (NICU) and the delivery room. Difficulties in performing neonatal ETI lie in the small     size of the mouth and airway of the neonate, and their particular anatomy of the larynx. This     limited visibility represents a challenge even for the experienced clinician. Recently, a new     videolaryngoscope (VL) technique has been introduced to the adult and pediatric medical     fields as described respectively by Kaplan et al. and Weiss et al. In 2009, Vanderhal et al.     reported a preliminary experience in the newborn population. Video assisted intubation could     be a method of choice in teaching neonatal ETI.      To the best of our knowledge, there is no human study comparing the VL to the classic     laryngoscope (CL) for acquiring the skill of neonatal ETI in the NICU.      This study aims:        1. To assess if the videolaryngoscope is superior to the classic laryngoscope in acquiring          the neonatal endotracheal intubation skill in the Neonatal Intensive Care Unit; and        2. To assess if once the skill is acquired with the videolaryngoscope this experience is          transferable to the use of the classic laryngoscope by showing a persistent difference          in success rate in favor of the videolaryngoscope group.      The hypothesis are        1. Primary hypothesis:           In the Neonatal Intensive Care Unit, use of the videolaryngoscope will increase success          rate of endotracheal intubation by 20% compared to the classic laryngoscope. Later,          acquired experience from the videolaryngoscope will be transferable to the use of the          classic laryngoscope by showing a persistent difference in success rate of 20% in favor          of the videolaryngoscope group.        2. Secondary hypothesis We expect that the videolaryngoscope will decrease time to          intubation, and decrease rate of esophageal and right bronchial main stem intubations.          It will also improve teaching of endotracheal intubations to pediatric residents by          helping supervisors recognize problems related to intubation and by improving residents'          level of confidence in performing the skill.   "
144366|NCT01394770|"     Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study     was undertaken to ascertain whether aliskiren, a direct renin inhibitor, compared with     amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these     high-risk patients.   "
144388|NCT01394484|"     Does the consumption of dairy foods reduce the rate of bone loss in older women more than     calcium and vitamin D supplements.   "
144367|NCT01394757|"     Alterations of functional brain networks have been frequently demonstrated in schizophrenia,     although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to     exert its schizophrenia-like effects through modulation of the glutamatergic system, thus     facilitating the investigation of the impact of this specific transmitter system on resting     state functional brain networks. The aim of the study is therefore to use pharmacological     functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved     in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects     (15 females) will be examined twice using a double-blind, placebo-controlled, randomized,     crossover, counterbalanced-order design. Resting state fMRI will be investigated before,     during and after either placebo or ketamine intravenous infusion for 20 minutes. Prior to the     main trial 10 additional participants will be included in an open pilot trial.      Hypothesis: Ketamine application will induce changes in resting state networks previously     associated with schizophrenia and in the connectivity of relevant brain regions such as the     striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of     ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed     before and after ketamine infusion.   "
144368|NCT01394744|"     The goal of the study is the analysis of metal ion serum concentrations and of the cytokine     production in the blood of patients with a conventional cementless total hip replacement. The     rationale is that a) the bearing wear releases particles respectively metal ions into the     joint and the blood which will differ in quantity and composition; b) the cytokine production     of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the     metal and the ceramic particles.      The patients from whom the respective samples will be analyzed are randomized in one of the     following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm     bearing is used in all patients. In this separate study, follow-up data of the clinical and     radiographic examinations of the patients are available.   "
144369|NCT01394731|"     The purpose of this study is to determine whether intravenous paracetamol is effective in     treating labor pain.   "
144370|NCT01394718|"     This is a prospective, randomized, double-blinded, placebo controlled trial Potential     subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal     guardians will be approached about study participation at the Anesthesia outpatient     pre-visit. Attending Anesthesiologist will receive e-mail notification about potential     subject participation the day before the scheduled surgery. Study lab (hepatic function     panel) will be collected as soon as possible after anesthesia induction by anesthesia.     Results will be reviewed by study team member and study drug will be ordered by study team if     patient does not meet exclusion criteria. Study drug (IV acetaminophen or placebo) will be     administered at the time of skin closure by anesthesia on completion of the surgical     procedure (after randomization). Study drug will be administered every 6 hours for 2 days.     Subjects will continue to receive standard of care with patient controlled analgesia (PCA)     opiate therapy (morphine or hydromorphone) for analgesia as per the Pain Management Service.     Pain scores, opiate (morphine equivalent) administered, requirements for treatment of opiate     related side effects (treatment for nausea and itching), and certain post-operative     characteristics will be measured for up to 4 days post-operatively (time to mobilization,     time to diet advancement, time to discharge).   "
144371|NCT01394705|"     This pilot study seeks to compare the change in energy expenditure and fitness levels of     patients seen in the Children's Hospital Preventive Cardiology program receiving standard of     care provider exercise counseling to similar patients receiving Frequency, Intensity, Time,     Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an     online interactive tool.      The investigators primary hypothesis is that this interactive technology coupled with support     from a exercise specialist will increase the energy expenditure of the investigators patients     over standard of care provider counseling.      The investigators Secondary hypotheses include greater improvement in measured physical     fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold     (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial     stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group     compared to control.   "
144372|NCT01394692|"     Excision to the maximum possible extent marks the first step of glioma surgery. Depending on     tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre     studies have shown that the presence of residual tumour according to MRI-criteria is a     prognostic factor in this incurable condition.      In order to improve the extent of resection, several methods, in particular intraoperative     imaging techniques, have become available to demonstrate already during surgery whether the     goal of surgery has been achieved. The intraoperative MRI devices currently available differ     in their magnetic field strengths and image resolution, but also in their amount of     interference with the surgical workflow.      Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma     surgery are lacking. To assess whether the rate of radiologically complete tumour resections     can be improved by using intraoperative MRI-guidance, we designed this prospective,     randomized trial. We hypothesized that the extent of resection that can be achieved using an     intraoperative MRI is greater than that of conventional microsurgical tumor resection.   "
144373|NCT01394679|"     The purpose of this study is to determine if the images of the primary lesions of lung cancer     and any metastatic lesions seen from the investigational SPECT/CT 99mTC-EC-DG scans are the     same as the PET/CT 18F-FDG scans.   "
144374|NCT01394666|"     The purpose of this study is to evaluate treatment patterns and associated outcomes for     CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.   "
144375|NCT01394653|"     A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating     tablet with those of conventional tablet. Tablets will be administered with water.   "
144389|NCT01394471|"     Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves     social cognition, psychotic symptoms and social functioning in schizophrenia.      Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one year.      Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal     spray for 12 weeks. Before, during and at the end of the trial, each subject will undergo     psychiatric symptom ratings and tests of mental abilities used in social functioning,     cognition, and social competence.   "
144376|NCT01394640|"     Primary objective      1) To assess whether oncologic and hematologic patients develop a protective immunological     response after pandemic Influenza A (H1N1) vaccine      Secondary objectives        1. To compare the levels of antibody response against A (H1N1) influenza virus between          oncologic and hematologic patients relative to a cohort of healthy volunteers        2. To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic          patients in comparison with a cohort of vaccinated healthy volunteers. To assess the          clinical symptoms attributable to influenza infection in vaccinated oncologic and          hematological patients and healthy volunteers.        3. To compare the levels of antibody response against A (H1N1) influenza virus between the          following subgroups: patients with ongoing chemotherapy; patients who have completed the          chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood          hematopoietic stem cell transplant (PBSCT)      Study procedures: Onco-hematological patients will perform a blood sample collection before     the vaccination, on day +21 after vaccination , on day +50 and on day +90. At the end of the     collection, the investigators will perform immunological test to evaluate the antibody titer     and the cellular response. The titer of antibodies against the vaccine strain will be     measured in all samples by hemagglutination-inhibition (HI) assays with the use of turkey     erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a     protective title of HI test > 1:40. In addition, the investigators will evaluate: geometric     mean titers and a fourfold titer increase compared with prevaccination titers.     Cellular-mediated response will be analysed by flow-cytometry. A control cohort of healthy     volunteers who received A(H1N1) vaccine will perform the same blood sample collection.      Evaluation of clinical response: Oncologic and hematologic patients will be followed as     outpatients or inpatients according to routine controls for their disease. In case that     symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be     recorded in the clinical database, nasal and pharyngeal swaps will be performed according to     the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of     the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further     studies will be performed after 3 months from the vaccination.   "
144377|NCT01394627|"     The purpose of this study is to look at whether blockade of the mineralocorticoid receptor     will result in changes in the cardiovascular and inflammatory response to hypoglycemia. We     are also looking at the effect of hypoglycemia on fMRI.   "
144378|NCT01394614|"     The goal of the study is to assess the risk of occurrence of narcolepsy following the     administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the     province of Quebec, Canada, using different case definitions and time intervals to disease     onset, while controlling for potential confounding variables such as age, gender, season and,     when possible, A/H1N1 pandemic influenza infection. Another aim is to describe the     epidemiology and clinical features of narcolepsy cases with onset during the period January     1st, 2009 to December 31, 2010 in the population of Quebec.   "
144379|NCT01394601|"     RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients     who are hospitalized due to an acutely agitated psychotic episode. The patients should be     managed according to normal clinical practice until discharge time. Data will be collected by     review of medical records of the hospitalisation prior the study visit. During the study the     patients will conduct one visit on the day of their discharge after hospitalisation due to an     acutely agitated psychotic episode. On the study visit data on demographics, diagnosis and     medical history will be recorded. Data on antipsychotic and concomitant medication will be     collected by review of medical records.   "
144380|NCT01394588|"     This is an observational study of continuous glucose monitoring technology during cardiac     surgery. The investigators would like to develop data for descriptive analysis of a     comparison of continuous glucose monitoring with a gold standard under the conditions of     cardiac surgery.   "
144381|NCT01394575|"     This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma     in situ treated by breast conserving surgery, postoperative whole breast irradiation with     inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically     feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and     local control rate in a single center   "
144382|NCT01394562|"     The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves     exercise capacity, physical functioning and quality of life in patients with iron deficiency     and chronic heart failure.   "
144383|NCT01394549|"     Despite efforts of learned societies, community cardiology and more generally of most players     in the health, cardiovascular diseases continue to be the leading cause of death among women     in France and all over the Western world, there where they fell to second place among men.     Clinical practice and the disparity between the sexes are still insufficiently known.      Multicenter observational study on a cross-week comparative basis with men   "
144384|NCT01394536|"     Postoperative nausea and vomiting after outpatient surgery are significant sources of patient     dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally     as important as prevention of pain because both are large sources of patient dissatisfaction     and can necessitate admission after routine outpatient procedures.      None of the currently available pharmacological interventions are able to totally abolish     PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has yet     to be studied when the patient takes the device home with them after leaving an outpatient     facility.   "
144385|NCT01394523|"     The literature has clearly demonstrated that the effective treatment of postoperative pain in     infants and children is challenging. In an effort to improve postoperative analgesia while     limiting opioid-related adverse effects, there continues to be an increased use of regional     anesthetic techniques in infants and children. Although the pediatric caudal remains the most     commonly used pediatric regional anesthetic technique, it has been demonstrated that     effective analgesia can be provided with the use of peripheral nerve blockade even in the     pediatric-aged patient. The purpose of this study is to prospectively compare post-operative     pain relief in pediatric patients undergoing umbilical hernia repair who have received either     a caudal block or bilateral rectus sheath blocks for analgesia   "
144386|NCT01394510|"     Insulin is secreted by cells in the pancreas called beta-cells. Beta-cell dysfunction is a     critical feature of type 2 diabetes (T2DM). High glucose levels can exacerbate beta-cell     dysfunction with oxidative stress proposed as a major mediator of this glucotoxic effect.     High glucose levels have also been shown to contribute to vascular dysfunction and     inflammation and these adverse responses decreased with the use of antioxidants. The     hypothesis is that antioxidants improve beta-cell function in individuals with elevated     glucose levels by decreasing oxidative stress. In this study the investigators will     specifically test whether the antioxidant N-acetylcysteine (NAC) can improve beta-cell     function in individuals with type 2 diabetes by decreasing oxidative stress.      This study will be a dose finding study to determine the tolerability of 600 mg versus 1200     mg twice a day of NAC and the effects on beta-cell function, glucose tolerance and oxidative     stress markers in persons with type 2 diabetes.   "
144387|NCT01394497|"     Randomized prospective study on the impact on the post-LT outcome by the infusion of     N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to     reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).   "
144396|NCT01394380|"     The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can     soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks,     subjects will be randomized to either a 12-week intervention arm in which sweetened beverages     will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The     following measurements will be performed at the end of the run-in period and at the end of     the intervention period        -  intrahepatic fat concentration        -  visceral fat volume        -  changes in day-long metabolic profile from baseline(plasma glucose, insulin, and          triglyceride concentrations)        -  changes in food intake and daily energy, carbohydrate and sugars intake from baseline   "
144397|NCT01394367|"     Aim of this study is to investigate whether and to what extent a cautious respiratory and     exercise therapy can complement medical treatment and change the condition, oxygen uptake,     quality of life, the pulmonary vascular pressures, the size of the right heart and the     6-minute walk distance in patients with pulmonary hypertension.   "
144398|NCT01394354|"     Primary objective of the study is the determination of the maximum tolerated dose (MTD) of     Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and     Dexamethasone (D).      Secondary objectives are:      Assessment of safety and tolerability of VBDD; efficacy data of VBDD.   "
144399|NCT01394341|"     Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is     new and fundamentally different from the classical treatments with oral antidiabetic agents     and insulin. The novel and original aspect of this investigator-initiated study is the focus     on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients     with severely reduced kidney function. At present there is virtually no knowledge of the     physiology and clinical implications of the role of incretin hormones and incretin-based     therapy in this group of diabetic patients.The aim of the study is to establish an     evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of     antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall     hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit     from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and     reducing risk factors of cardiovascular disease   "
144400|NCT01394328|"     The aims of this study were to identify risk factors associated with delirium in hospitalized     persons with dementia, and to describe immediate and post-hospital (1&3 months) trajectory of     cognitive decline and associated outcomes in persons with dementia who develop delirium. It     was hypothesized that factors such as CNS-active medications, urinary tract infection, stage     of dementia, pain, activity level, and dehydration would be associated with an increased risk     of delirium and delirium severity in patients with dementia compared to dementia patients     without delirium. It was also hypothesized that persons with DSD will have worse outcomes     (longer hospital length of stays, decreased functional status, a steeper negative slope of     cognitive decline) than dementia patients without delirium. Lastly, it was hypothesized that     higher delirium severity would be associated with poorer outcomes in persons with dementia.     The long-term objectives were to use the results from this study to design and test an     intervention strategy to improve early recognition, management, prevention, and outcomes in     persons with DSD.   "
144401|NCT01394315|"     The aim of the study is to determine if DOT can detect response early in breast cancer     patients undergoing neoadjuvant chemotherapy.   "
144402|NCT01394302|"     The purpose of this study is to Characterize the population of people who suffer from trigger     finger (TF) in terms of demographic (Gender, age, occupation, etc.); motor skills (hand     function); the Consequences of the disease on a person's daily functioning and impact on     quality of life.      The study will also attempt to examine the suitability of several common assessment tool for     evaluation of hand rehabilitation Patients who suffer from TF.      Information obtained from the study will enable a deeper comprehension of the consequences of     TF on the patient and will be the first step in developing a protocol assessment and     evidence-based treatment in this population.   "
144403|NCT01394289|"     The objective of this study is to determine the biologic activity of a Lolium perenne     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house     reference preparation (IHRP).   "
144404|NCT01394276|"     This observational study will evaluate the efficacy and safety of RoActemra/Actemra     (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis.     Data will be collected from patients for the 12 months following the first infusion of     RoActemra/Actemra.   "
144405|NCT01394263|"     This trial was an open-label, multi-national, randomized, parallel treatment, active-control     multicenter study in adult males with documented metastatic prostate cancer disease who were     judged to be candidates for hormone therapy.   "
144406|NCT01394250|"     The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable     device that provides cold and vibration, in reducing the pain associated with intravenous     (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical     lidocaine cream in reducing the pain associated with IV cannulation.   "
144409|NCT01394211|"     This phase II trial studies how well giving pazopanib hydrochloride and anastrozole before     surgery works in treating patients with stage II-III estrogen receptor-positive breast     cancer. Pazopanib hydrochloride and anastrozole may stop the growth of tumor cells by     blocking some of the enzymes needed for cell growth. Giving pazopanib hydrochloride and     anastrozole together before surgery may make the tumor smaller and reduce the amount of     normal cells that have to be removed   "
144410|NCT01394198|"     The purpose of this study is to correlate the link between palpatory findings of somatic     dysfunction and gastrointestinal endoscopic evidence of changes in mucosa. The investigators'     hypothesis is that there is a direct connection between somatic palpatory changes and     intestinal mucosal changes via a somatovisceral/viscerosomatic mechanism.   "
144411|NCT01394185|"     Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days     in a randomized order. During each dronabinol maintenance period they were able to     self-administer active or placebo cannabis using either a progressive ratio schedule or     choice between cannabis and monetary alternative.   "
144412|NCT01394172|"     The purpose of this study is to quantify the tidal volume generated by the pressure release     immediately following the application of pressure to the chest.   "
144413|NCT01394159|"     The aim of this research study is to identify the best needle for performing biopsy during     EUS procedures. There are two types of needles for performing biopsy: A FNA needle that     provides a small sample of tissue for analysis and a ProCore needle that provides larger     amount of tissue. It is not clear at this point which of the two needles is superior for     performing biopsy. This study will attempt to identify the better needle by assessing the     performance of both needles in a randomized fashion.   "
144414|NCT01394146|"     The purpose of the study is to learn more about how phosphorus-based food additives affect     phosphorus metabolism in people with normal kidney function.   "
144415|NCT01394133|"     Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have higher     amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The     reason for this higher drug exposure has not yet been determined. The primary purpose of this     study is to examine whether a pharmacokinetics (factors that determine the amount of drug in     the body) of anti-HIV drugs change during different phases of the menstrual cycle in women     and ultimately result in higher amounts of drug in the body compared with men. In other     words, we plan to examine whether changes in sex hormones throughout the menstrual cycle     affect the amount of anti-HIV drugs in HIV infected women. The antiretroviral drugs     atazanavir, ritonavir, tenofovir and emtricitabine will be studied.   "
144416|NCT01394120|"     In recent years, treatment of advanced pancreatic cancer is changing. Currently, there are     several active schedules of chemotherapy that can be used, such as gemcitabine as monotherapy     or in combination with capecitabine or erlotinib, and FOLFIRINOX. Moreover, the development     of biomarker (therapeutic targets) that can predicte response to treatment is a new important     tool to be used in clinical practice to select the best scheme for each patient. Preliminary     studies showed that therapeutic target determination, using tumor tissue collected from     patients, could determine the presence of groups of chemotherapy responders. Such is the     case of EGFR amplification and/or K-Ras gene status and correlation with response to     erlotinib. Moreover, Thymidilate Synthase, Thimidine Phosphorylase, ERCC-1 and Topoisomerase     I expression by immunohistochemistry in GI tumor samples has been related to resistance or     response to 5FU-capecitabine, oxaliplatin and irinotecan respectively. Based on this data the     investigators designed a phase II clinical trial to evaluate the efficacy of selected     treatment for pancreatic cancer patients based on the determination of therapeutic targets.     The therapeutic target-driven treatment efficacy will be compared to the prospective     treatment of a control group of patients treated at the discretion of the     physician-researcher   "
144417|NCT01394107|"     The project aims to clarify the effect of the thromboprophylactic LMWH dose on coagulation in     pregnant women just before birth, at the period of maximal physiological hypercoagulable     state and with high risk of thromboembolism, the most common cause of maternal mortality in     developed countries. Although LMWH are now routinely administered as prevention of     thromboembolism, their effect on coagulation in pregnant women was not yet studied. The doses     of LMWH in pregnancy are only derived in terms of coagulation from totally different groups     of patients (surgical, orthopedic). We therefore will map the effect of thromboprophylactic     LMWH dose on coagulation in pregnant women using recently available methods, especially a     complex examination of coagulation within 24 h after LMWH application using     thrombelastography, including examination with heparinase, and monitoring the effect of LMWH     by measuring antiXa and TGT (thrombin generation time) activity. Based on these results we     will also evaluate the possible influence of LMWH prophylaxis on the risk of spinal haematoma     during neuraxial analgesia/anesthesia for delivery/Caesarean section. On the basis of our     pilot results we can presume the current dosage of LMWH in pregnant women is inadequate and     that it would be appropriate to adjust presently used dosage. At the same time we want to     prove that the standard LMWH thromboprophylaxis in pregnant women does not increase the risk     of spinal haematoma during neuraxial blockade. In both situations the targeted outcome is to     increase the safety of pregnant women.   "
144418|NCT01394094|"     Gum chewing can promotes the return bowel function after gynecologic surgery.   "
144463|NCT01393509|"     NOTE: This study is now recruiting only patients with Myeloproliferative Neoplasms (MPN).     Dose escalation has been completed.      The purpose of this study is to test a new drug, called PU-H71 for the first time in humans,     to find out what effects, good or bad, this new drug has on the patient and the cancer at     different dose levels. PU-H71 blocks a protein called Heat Shock Protein-90 (Hsp90). Hsp90 is     found in both normal and cancer cells, but may be more important in cancer cells. Attacking     Hsp90 can stop the function of certain proteins that are needed for cancer cells to survive.     The diseases that are part of this study may be especially sensitive to attacking Hsp90, and     the investigators have seen signs of disease control in patients with MPN. This study is     currently enrolling a cohort expansion for patients with myeloproliferative neoplasms (MPN).   "
144464|NCT01393496|"     To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on     long-term neurodevelopmental outcome in extremely low birth weight infants.   "
144419|NCT01394081|"     The purpose of the Alabama Veterans Rural Health Initiative is to better understand access     and barriers to health care and to enhance veteran enrollment or engagement in health care     services of veterans residing in rural areas. It describes an intervention that is adaptable     for use by other VA facilities that serve veterans in rural settings, and importantly, this     study will improve our understanding of barriers to care and evaluate a method for enhancing     access to care. The anticipated impact is that more veterans in rural areas who were     previously under-utilizing VA services will receive and attend a health care appointment.     This gain may improve preventative and primary care health care and reduce long term health     care morbidity, expense and burden. This study may also identify previously unknown barriers     to care that can be surmounted by innovative access and health care delivery approaches.      The primary objective is to evaluate an innovative approach for enhanced enrollment or     engagement intervention (EEE intervention) for rural veterans in VA health care services.     Phase I entails a two-cell design, addressing this objective with a prospective, randomized     controlled multi-site clinical trial that evaluates an active intervention compared to a     control treatment as usual (TAU)condition on whether or not a rurally-residing veteran     obtains and attends a VA appointment. Phase II encompasses a three-cell design, addressing     the above mentioned objective with a randomized controlled, multi-site clinical trial that     evaluates two active interventions compared to a control intervention.   "
144420|NCT01394068|"     In this observational study the effect of selenium supplementation on the postoperative     inflammatory response and clinical course should be examined in (approximately 100) adult     patients undergoing elective heart surgery combined with extracorporeal circulation.      Selenium is one of the essential trace elements with a variety of important immunological and     antioxidant properties. The pathophysiological relevance of different selenium-dependent     reactions has already been demonstrated in human and in animal experiments. It is essential     for the enzymatic functions of selenium-containing proteins such as the glutathione     peroxidase, which in turn affects the leukotriene, thromboxane and prostacyclin metabolism.     In addition, selenium has a significant influence on various liver enzymes, therefore     selenium deficiency leads to oxidative or chemically induced liver damage.   "
144421|NCT01394055|"     The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK)     profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and     delayed gastric emptying.   "
144422|NCT01394042|"     This is a small study to determine if probe, similar to an ultrasound probe, can detect     prostate cancer more specifically than other imaging studies in patients with a positive     prostate cancer biopsy.   "
144423|NCT01394029|"     This study will observe patients with transfusional hemosiderosis treated with deferasirox in     actual practice setting.   "
144424|NCT01394016|"     The purpose of this study is to determine a safe dose of LY2835219 to be given to     participants with advanced cancer and to determine any side effects that may be associated     with LY2835219 in this population. Efficacy measures will be used to assess the activity of     LY2835219 in this population.   "
144425|NCT01394003|"     The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that     may be safely administered to patients with advanced/metastatic cancer.   "
144426|NCT01393990|"     The objective of this study is to determine a safe dose of LY2228820 that may be given to     patients with advanced cancer. Part A of this study will consist of dose escalation, and Part     B will consist of dose confirmation.   "
144427|NCT01393977|"     The morbidity of spinal cord injury (SCI) is increasing significantly in China. The methods     to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation     therapy is the routine method to treat SCI in sequela stage, its effect to improve the     neurological disorders of these patients, such as the dysfunction of sense, motor, autologous     adjustment of blood pressure control of urination and defecation, perspiration , etc. is     unsatisfying. Rehabilitation Therapy can prevent the process of muscle atrophy and joint     stiffness. However, it can not repair the damaged nerve function. Studies show that     mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI     in animals without any severe side effect.      In this study, the investigators use mesenchymal stem cells derived from umbilical cord to     treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The     investigators also follow-up ten patients who only receive rehabilitation and another ten     outpatients who accept neither stem cell therapy nor rehabilitation. On this basis, the     investigators can compare the efficacy of these two treatments.   "
144428|NCT01393964|"     The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients     with very low kidney function including patients on dialysis.   "
144429|NCT01393951|"     This trial is designed as a blinded, randomized and parallel group study to investigate the     clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and     safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in     healthy adults.   "
144430|NCT01393938|"     Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated     to be around 2% in the general population, and 6% to 7% in women with a history of recurrent     pregnancy loss. Mullerian duct anomalies are associated with recurrent pregnancy loss, intra     uterine growth retardation, and preterm labor and birth. The prevalence of preterm birth and     pregnancy loss varies with the type of MDA. Patients can benefit from surgery or     hysteroscopic interventions like metroplasty based on the type of MDA. Therefore, to optimize     patient outcomes, accurate diagnosis and description of MDAs is essential.      Magnetic resonance imaging (MRI) is an excellent way of evaluating the uterus for MDAs. MRI,     although costly, is less expensive than laparoscopy and hysteroscopy and is non-invasive.     Pellerito et all evaluated 26 women with surgically proven MDAs and found that in 24 cases     MRI was able to correctly diagnose the MDAs. Therefore MRI is generally considered as a     reference standard for uterine evaluation. In a study comparing MRI and endovaginal     Two-Dimensional Ultrasound (2DUS), MRI appeared to be more accurate than 2DUS with a     sensitivity of 77%, specificity of 33%, and a positive predictive value of 83%.      Endovaginal Three-Dimensional Ultrasound (3DUS) is a relatively new technology that creates     three-dimensional volumes from a series of two-dimensional images. This technique allows the     user to acquire coronal or face-on-view of the uterus which is essential in evaluating the     uterus for the presence of MDAs. Kupesic and Kurjak used 3DUS to evaluate 86 patients and     found that it had sensitivity of 98.38%, specificity of 100%, a positive predictive value of     100%, and a negative predictive value of 96% in the diagnosis of septate uteri [7].     Endovaginal 3DUS is less expensive, less invasive, and less-time consuming than hysteroscopy     or MRI and appears to be a very promising technology for the evaluation of MDAs. 3DUS appears     to be at least as accurate as MRI in the diagnosis of MDAs. In addition, 3DUS is less     expensive than MRI and in some patients better tolerated. If validated using prospective     studies, 3DUS has the potential to become the reference standard for the diagnosis of MDAs.   "
146573|NCT01365767|"     The purpose of this study is to determine how relevant dynamic ultrasound scans using     contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared     to dynamic Magnetic Resonance Imaging (MRI) of the small bowel.   "
144431|NCT01393925|"     This prospective, double blind, placebo-controlled, parallel group study will be conducted in     the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged     18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia     will be involved in this study. According to previous studies and our pilot trial, the sample     size was estimated to be 120 subjects. All eligible patients will be randomly assigned to one     of three groups: Group A (single parecoxib) receiving parecoxib 40mg at 30min before the end     of surgery; Group B (multiple parecoxib) receiving parecoxib 40mg at 30min before the end of     surgery, at 8h and 20h after the surgery, respectively, and Group C (Control group) receiving     normal saline. All patients will be managed by a standard propofol-remifentanil based total     intravenous anesthesia protocol. The incidence and intensity of shoulder pain at rest and     with motion will be evaluated by an independent doctor blinding to medication and grouping     using visual analog scale (VAS) at 6h, 24h and 48h postoperatively. Other types of pain (e.g.     trocar wound and visceral pain), side effects (such as postoperative nausea and vomiting,     itching, dizziness, and oversedation) will be assessed as well. At the end of the     observation, the intensity of the maximum pain will be recorded, and the effect of shoulder     pain on the four variables regarding to quality of life (activity, mood, walking and sleep)     will be assessed using modified Brief Pain Inventory(BPI) questionnaire.   "
144432|NCT01393912|"     This is a Phase I clinical trial evaluating crenolanib (CP-868,596), an inhibitor of Platelet     Derived Growth Factor Receptor (PDGFR)-kinase in children and young adults with newly     diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) or in recurrent, progressive or     refractory High Grade Glioma (HGG) including DIPG (Stratum B). This study drug targets the     most commonly amplified region of genome found in DIPG and pediatric high grade glioma (HGG)     which encodes for the PDGF receptor kinase. An oral investigational agent crenolanib will be     administered daily during and after local radiation therapy (RT) in Diffuse Intrinsic Pontine     Glioma DIPG (Stratum A), or daily for children with recurrent/refractory HGG (Stratum B).   "
144433|NCT01393899|"     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to     severe Crohn's disease who completed the double-blind induction treatment in Study A3921083     and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.   "
144434|NCT01393886|"     The aim of this study is to find out the safety and efficacy of Laparoscopic Greater     Curvature Plication (LGCP) procedure. This study procedure is an alternative restrictive     weight loss surgery that has the potential to reduce the complications associated with     gastric banding and sleeve gastrectomy by creating a small sized stomach without the use of     an implant and without cutting stomach.   "
144435|NCT01393873|"     Studies conducted assessing diabetic eye disease have shown a progression of diabetic     retinopathy with rapid improvement of glycemic control during pregnancy and in patients with     type 1 diabetes. It is also well documented that bariatric surgery may result in rapid     improvement of glycemic control in obese patients with type 2 diabetes. To our knowledge the     progression of diabetic eye disease seen in pregnancy and type 1 diabetes has not been     studied in obese type 2 diabetics undergoing bariatric surgery. To this end, this study will     examine the effects of rapid glycemic control which is seen in type 2 diabetics following     bariatric surgery on the progression of diabetic retinopathy.   "
144436|NCT01393860|"     The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of     change in renal function following aliskiren initiation as well as to identify triggering     events that lead to aliskiren initiation.   "
144437|NCT01393847|"     Background:      - Sickle cell disease often causes crises, with episodes of pain. Many people with sickle     cell disease also have pain between crises. Inflammation is an important part of sickle cell     pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that     helps relax blood vessels and may be related to the pain from sickle cell disease.     Researchers want to study the relationship between blood levels of nitric oxide and pain in     people with sickle cell disease. Researchers also want to study how certain genes express     themselves related to sickle cell pain.      Objectives:      - To collect blood samples and other genetic expression information to study sickle cell pain     and its relation to nitric oxide levels in the blood.      Eligibility:        -  People at least 18 years of age who have sickle cell disease.        -  Healthy volunteers at least 18 years of age.      Design:        -  This study requires a screening visit and four study visits scheduled 1 week apart. Each          visit will last about 1 hour.        -  Participants will be screened with a medical history and physical exam. They will          complete questionnaires about pain levels (if any). They will also provide blood samples          for genetic and other testing.        -  Participants will have a breath test to see how much nitric oxide they exhale. They will          also have a test of their ability to detect small changes in temperature and touch.        -  Participants will keep a diary to record daily pain levels and pain medicines taken.          They will write down what they eat to track foods that contain nitrates (such as meats          like ham and bacon and vegetables like beets and spinach).        -  At each of the four study visit, participants will bring the pain diary, provide blood          samples, and have breath nitric oxide tests.   "
144438|NCT01393834|"     This study is being done to evaluate if delaying cord clamping or milking the umbilical cord     of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies     among doctors, but there is information that shows that delaying clamping of the umbilical     cord in premature infants may reduce the rate of the baby needing a blood transfusion,     decrease the risk of infection and bleeding in the head.   "
144439|NCT01393821|"     This clinical trial studies menadione topical lotion in treating skin discomfort and     psychological distress in patients with cancer receiving panitumumab, erlotinib     hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin     discomfort and help alleviate psychological distress and pain in patients receiving treatment     with panitumumab, erlotinib hydrochloride, or cetuximab   "
144466|NCT01393470|"     Summary      For ethical and practical reasons pre-licensure clinical efficacy phase III trials for GSK     Biologicals' HPV-16/18 LI VLP AS04 vaccine used cervical intraepithelial grade 2 and above     (CIN2+) lesions as surrogate efficacy endpoint for cervical cancer. The long-term impact of     HPV vaccination on cervical cancer as well as other HPV-related non- cervical cancers is,     however, an area warranting further exploration in the post-licensure setting. Results of the     multinational phase III trial demonstrated high vaccine efficacy against CIN2+ associated     with HPV-16 and/or HPV-18, significant vaccine efficacy against CIN2+ and CIN3+ irrespective     of HPV type in the lesion as well as evidence of protection against CIN2+ associated with HPV     types 31 and 45 [Paavonen, et al. 2009]. Over time, vaccinated cohorts should benefit from a     substantial reduction in the incidence of cervical cancer considering impact on oncogenic     non-vaccine HPV types. This long-term study is conducted to evaluate the long-term impact of     GSK Biologicals' HPV-16/18 vaccine on the occurrence of cervical pre-cancerous lesions and     cervical cancer with the following objectives:        -  To assess the long-term efficacy of the HPV-16/18 L1 VLP AS04 vaccine on the occurrence          of cervical cancer including its immediate precursors (CIN3+): cervical intraepithelial          neoplasia grade 3 (CIN3) and adenocarcinoma in situ (AIS) by comparing cohorts A and C          (see below).        -  To assess the efficacy of HPV-16/18 L1 VLP AS04 vaccine on the occurrence of the          following potentially HPV related non-cervical cancers such as vulvar intraepithelial          neoplasia, vaginal intraepithelial neoplasia, anogenital neoplasia and oropharyngeal          neoplasia by comparing cohorts A and C (see below)        -  To assess as an explanatory objective the occurrence of CIN3+ breakthrough cases          associated with HPV-16 or HPV-18 infection in subjects vaccinated with HPV-16/18 L1 VLP          AS04 vaccine by close surveillance of cohorts and cross vaccinated cohort B (see below)      This prospective, observational cohort study is undertaken in originally 16-17 year-old     Finnish females who have participated in the GSK Biologicals' HPV-008 trial (NCT00122681)     with regular clinical follow-up, and can be divided in Cohort A: Female subjects from Finland     who received HPV-16/18 L1 VLP AS04 vaccine in the HPV-008 study between May 2004 and May 2005     (N=2409), and Cohort B: Female subjects from Finland who received the Hepatitis A control     vaccine in the HPV-008 study (N=2399). All subjects were offered the HPV-16/18 L1 VLP AS04     vaccine or screening for cervical cancer at the end of the study (age 21-22): 50% of the     subjects, chose not to take cross-over HPV vaccination at HPV-008 study end. Referent Cohort     C: A population-based reference cohort of female subjects from Finland who have not been     exposed to any HPV vaccine (either during a HPV vaccine trial, or commercially available     vaccine; i.e. Cervarix or Gardasil), enrolled in this study in May - September 2003 or May -     September 2005, altogether 15536 subjects).      Prospective data collection will start at the HPV screening invitation for each subject in     2013. Several analyses are planned including an analysis at 8 years post-completion of the     HPV-008 study (by 2020) and will provide a total evaluation time of approximately 15 years     since first vaccination in the Cohort A.      The study is self-contained for the primary and secondary endpoints. Data from the HPV-008     trial will be used to address exploratory objectives mentioned above. Data collection will be     performed using the databases from the University of Tampere.   "
144440|NCT01393808|"     Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for     renal disease progression. More proteinuria is associated with faster progression, whereas     treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic     chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower     is the disease progression in the long term. On the basis of the above findings, proteinuria     has become a target of renoprotective therapy.      Among different antihypertensive medications, those that inhibit the Renin Angiotensin     System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor     blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce     proteinuria and slow renal disease progression. Thus they have become the key component of     renoprotective therapy in patients with proteinuric chronic kidney disease. Observational     studies found that their effectiveness, however, is limited or even fully blunted in patients     who eat large amount of salt.      Experimental evidence indicates a renoprotective role of the vitamin D system in chronic     renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D     receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with     type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor     therapy. This effect, however, was largely restricted to subjects with daily sodium intake     exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with     paricalcitol appears to be effective in particular in those patients who do not appreciably     benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake.     Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt     intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is     worth investigating.      The broad aim of this study is to evaluate the interaction between paricalcitol therapy and     sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable     background RAS inhibitor therapy.   "
144469|NCT01393431|"     Measurement of pH in Exhaled breath condensate has been mentioned as a robust variable from     lung inflammation. It is non-invasive and reproducible. The investigators measured pH in the     water condensed in the trap of expiratory arm of ventilator.In ICU the investigators measured     pH in condensed water without interfering with patients treatment. A group of critically ill     patients mechanically ventilated due to non pulmonary cause were followed until successful     weaning, death or pneumonia. The investigators found that pH did not change along the study     and it did not predict worsening condition.   "
144441|NCT01393795|"     The investigators hypothesise that pre-application of Qutenza® patches to the skin may reduce     pain at the site of Remodulin® SC infusion (sited 1 to 2 weeks later at the site of Qutenza     pre-application), in which case it would greatly improve the quality of life of the patients,     and enable many more to continue with this treatment. It may also provide new information to     support the use of Qutenza® patches for preventing and reducing pain produced by     inflammation.      The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8%     patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary     arterial hypertension patients, as assessed by changes in subjective pain rating score and/or     pain and sensory testing.   "
144442|NCT01393782|"     The investigators propose a dose finding study to determine the feasibility of Angiotensin II     (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to     increase mean arterial pressure, this could lead to future pharmacologic development based on     the AII hormonal pathway. The investigators propose a 20 patient, randomized,     placebo-controlled, blinded study in the treatment of high-output shock. Patients with     high-output shock and a cardiovascular SOFA (sequential organ failure score) score of > 4     will be eligible. In addition, patients must already be receiving cardiac output monitoring     and have a cardiac index > 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII     or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and     dose finding feasibility study. The investigators are starting with a small cohort consistent     with similar types of studies. The investigators estimate that ten patients in each arm will     generate a basis for determining if there is sufficient signal for AII to improve blood     pressure at the doses outlined. The primary endpoint in the study will be the effect of AII     on the standing dose of norepinephrine which is required to maintain a MAP of 65 mmHg.     Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine     clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day     30 will be contacted by telephone for this assessment.   "
144443|NCT01393769|"     For selected cases with advanced Retinoblastoma (RTB) intraocular involvement(stage V of the     Reese-Ellsworth classification) in which enucleation would usually be the standard     therapeutic approach, in this project the investigators propose an alternative conservative     treatment using intra-arterial chemotherapy with melphalan, via direct administration by     catheterization of the ophthalmic artery.   "
144444|NCT01393756|"     The purpose of the study is to assess the efficacy of the association of Lenalidomide     (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone)     in a population of patients with follicular lymphoma as measured by the response rate at the     end of treatment.   "
144445|NCT01393743|"     This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of     perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and     adults maintained on one to two stable antiepileptic drugs (AED).   "
144446|NCT01393730|"     The purpose of this research study is to determine if the addition of dutasteride to a     regimen with abiraterone acetate and prednisone will improve on therapy in patients with     castrate-resistant prostate cancer and metastatic disease. This study will also help     determine the side effects of the study treatment and how often they occur.   "
144447|NCT01393717|"     This phase II trial studies how well brentuximab vedotin before autologous (taken from an     individual's own cells) stem cell transplant works in treating patients with Hodgkin     lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer     growth in different ways by targeting certain cells.   "
144448|NCT01393704|"     The main purpose of this study is to compare blood loss at the time of laparoscopic or     robotically-assisted laparoscopic myomectomy when using different amounts of dilute     vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus.     Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic     surgery; although very little is know about the optimal dosage and administration.      The investigators plan to perform a randomized clinical trial on patients scheduled for     minimally invasive myomectomy. All patients will get the same overall amount of vasopressin.     Patients will be assigned by chance to one of two groups: one group will receive higher     volume of a more dilute vasopressin solution. The other group will receive a lower volume of     a more concentrated solution. The investigators will collect information on operative blood     loss and complications related to surgery.   "
144467|NCT01393457|"     The purpose of this study is to evaluate treatments designed to improve cocaine treatment     success by combining medications that target cocaine-related cognitive impairments.   "
144468|NCT01393444|"     The purpose of this research study is to demonstrate that individuals with upper limb     paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis     and brain stem stroke can successfully achieve direct brain control of assistive devices     using an electrocorticography (ECoG)-based brain computer interface system.   "
145066|NCT01385579|"     The purpose of this study is to determine if the direct mailing of fecal occult blood testing     (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to     improve colorectal cancer screening rates within a low income and racially/ethnically diverse     population.   "
144470|NCT01393418|"     The purpose of the study is to evaluate kidney biomarkers and determine if there is a     correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac     surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and     managing patients at risk for kidney failure after cardiac surgery. To evaluate     Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass     period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).   "
144482|NCT01393262|"     The purpose of the research is to investigate multiple facets of non-traumatic and traumatic     health issues. The majority of our research deals with mind-body aspects of health. The     investigators often correlate different psychological measures against one another or match     psychological and depression scores against standard of care objective measurements (grip     strength and range of motion).      The data repository also serves to streamline our studies and amalgamate many studies that     are no more than minimal risk and do not involve randomization in any way.   "
144449|NCT01393691|"     Nighttime fears (NTF) and sleep disruptions in preschool children continue to be major     problems in clinical services. The aim of this study is to test the efficacy of two     interventions designed for preschool children suffering from NTF: (a) a CBT adaptation     combining parent involved play, which will include multiple standard cognitive-behavioral     techniques, namely psycho-education, problem solving via play, gradual exposure and     reinforcement management; and (b) Triadic Expressive Play Therapy, based on Virginia Axline's     (1947) eight basic principles of play therapy. Parents will take an active part both in and     in between treatment sessions in both intervention groups. In addition to the review of the     outcomes of these interventions, the proposed study aims to identify variables that moderate     and mediate treatment effects.      In an attempt to meet these aims, the investigators will recruit 90 children suffering severe     NTF and their parents who seek treatment. At baseline the investigators will assess     children's NTF and general fears, sleep patterns and disruptions, behavior problems and     potential moderators (i.e. playfulness, oppositionality, desire for control and parental     anxiety). Assessment will be based on both objective and subjective measures, including     interviews with the child and parents, questionnaires and actigraphy. The investigators will     then randomly assign these children to one of two conditions: CBT with parent involved play     or Triadic expressive play therapy. Possible mediators (i.e. the therapeutic alliance,     patient compliance, motivation etc.) will be evaluated after each of the active intervention     sessions. The effects of the interventions will be assessed by comparing four time points:     baseline, first week of intervention, 1 month and 6 months subsequent to administration.      The main hypotheses of the proposed study are: (a) A positive correlation will be found     between the severity of NTF and the severity of sleep disruption at baseline, and a reduction     in NTF will be associated with an improvement in sleep; (b) Both interventions will     significantly reduce nighttime fears, but greater impact will be evident in the CBT group;     (c) Higher levels of playfulness and lower levels of oppositionality and desire for control,     as well as parental anxiety will predict desirable outcomes. (d) Stronger therapeutic     alliances, in addition to higher levels of motivation and compliance will be associated with     greater intervention effectiveness.   "
144450|NCT01393678|"     The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and     garlic oil. This components showed synergistic enhancing effects in previous tests. In phase     2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on     above, this study is phase 3 test to prove efficacy and safety of PENNEL.   "
144451|NCT01393665|"     The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic     oil. The two components were confirmed to have complementary effects because of different     operational mechanism in animal experiments, and were examined on humans in this study. Both     BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity     caused by toxic substances, and the purpose of this study is to confirm efficacy of and     safety on human body of the agent and to determine its optimal dose.   "
144452|NCT01393652|"     This is a two part study. The purpose of the first part (Part A) is the evaluation of the     pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The     second part (Part B) of this study will focus on the exploratory pharmacodynamics of     PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses     selected in Part B will have been administered previously in the Part A of the study.   "
144453|NCT01393639|"     The purpose of this study is to compare the safety and efficacy of multiple doses of     PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo     in the treatment of rheumatoid arthritis. All subjects will also be receiving background     treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for     eight weeks followed by a 4 week period during which the dose of study medication will be     gradually reduced. The efficacy of the study medications will be determined by assessing     severity of the rheumatoid arthritis during the study and safety will be determined by     adverse event reporting, laboratory tests and biomarker analysis.   "
144454|NCT01393626|"     This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to     severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is     more effective than placebo (inactive drug).   "
144455|NCT01393613|"     The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses     of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of     schizophrenia.   "
144456|NCT01393600|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses     (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive     dyskinesia in subjects with schizophrenia or schizoaffective disorder.   "
144457|NCT01393587|"     Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino     Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes     of oxidative stress.      The investigators would like to assess the usefulness of this marker during positive pressure     pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection (ischemia     induced by intra-abdominal pressure and vascualr compromise).   "
144458|NCT01393574|"     The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder     (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an     extent similar to that of stimulants treatment.      In order to check this hypothesis children with a new ADHD diagnosis who also have sleep     difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for     one month. The main outcome will be improvement of the ADHD symptoms.   "
144459|NCT01393561|"     This is a multicenter clinical trial, phase III, superiority, controlled by active medicine,     double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation     upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and     a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel     groups, and will receive the medicines of study, according of the randomization.   "
144460|NCT01393548|"     This is a multicenter clinical trial, phase III, non-inferiority, controlled by active     medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation     upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and     a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel     groups, and will receive the medicines of study, according of the randomization.   "
144461|NCT01393535|"     The purpose of this study is to investigate the relationship between serum adiponectin and     clinical prognosis in patients undergoing cardiac surgery.   "
144462|NCT01393522|"     The purpose of this study is to determine if milnacipran taken twice daily is effective in     reduction of headache pain.   "
144493|NCT01393119|"     The purpose of this study is to determine the appropriate loading and maintenance dose of     GTx-758 to reach and maintain castration for the duration of the study.   "
145067|NCT01385566|"     This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both     intradermally and subcutaneously at various doses.   "
144471|NCT01393405|"     There are fewer therapeutic options for patients with active ulcerative colitis (UC) compared     to patients with active Crohn's disease (CD) and the investigators are facing a persistent     unmet need for additional effective and affordable therapies for patients with UC.     Methotrexate (MTX) 25 mg once weekly administered subcutaneously (sq) or intramuscularly (im)     is an efficient therapy to induce and maintain steroid free remission in patients with CD. To     evaluate the efficacy of a similar approach in patients with active ulcerative colitis the     investigators conduct a double-blind, placebo controlled, randomized, multicenter, parallel     group trial to investigate the safety and efficacy of 25 mg MTX applied subcutaneously once     weekly in patients with active UC, who either failed 5-ASA therapy, or are steroid dependent     or are intolerant or not responding to azathioprine/6-mercaptopurine therapy or have no     response/ lost response to infliximab prior to the study inclusion. The study is designed as     a drug withdrawal trial and includes two periods, the Induction Period (week 0-16) and the     Maintenance Period (week 17-48). In the open label Induction Period every patient will     receive a steroid taper, MTX 25 mg sq once weekly + daily folic acid 1 mg tablets for the     induction of clinical response or remission. Patients responding to the open label MTX     therapy and being off steroids between week 12-16 will be randomized at week 16 1:1 to     Placebo sq once weekly + daily folic acid 1 mg tablets + 2.4 g mesalamine or to MTX 25 mg sq     once weekly + daily folic acid 1 mg tablets+ 2.4 g mesalamine. The Specific Aims of the trial     are: i) To evaluate the safety and tolerability of 25 mg MTX applied sq once weekly over a     time period of 48 weeks; ii) To evaluate the relapse-free survival of MTX maintenance therapy     compared to placebo over a time period of 32 weeks; iii) To evaluate the efficacy of MTX over     a time period of 16 weeks to induce steroid free remission; iiii) To establish a DNA, plasma     and serum library to enable the evaluation of clinical and pharmacogenomic models to predict     the response to MTX therapy in patients with UC. With 25-30 participating centers actively     enrolling, the investigators anticipate to complete enrollment for this study in a time     period of 3 years. Completion of this trial will define the therapeutic value of MTX in UC,     potentially changing the current therapeutic strategy in UC.   "
144472|NCT01393392|"     The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the     immediate and long-term effects of a newly developed, tailored, intensive smoking cessation     intervention among methadone maintained smokers and compared to a control condition     (facilitated referral to the NJ Quitline). The newly developed intervention is evidence     based, addresses the unique needs of methadone maintained smokers, is intensive, can be     tailored to the individual, and builds on the strengths as well as addresses the gaps in     previous treatments for methadone maintained smokers.      The investigators hypothesize that: (1) three months and six months after beginning     treatment, those in the tailored intervention condition will be more likely to be abstinent     from smoking than those in the control intervention condition (primary outcome); (2) there     will be a greater relapse rate in the control intervention condition between the three and     six month follow-up points than in the tailored intervention condition; (3) three and six     months after beginning treatment, those in the tailored intervention condition will have     better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week,     be more ready to quit, have greater self-efficacy for quitting, experience less nicotine     dependence, and be more likely to have made a quit attempt) than those in the control     intervention condition; (4) three and six months after beginning treatment, those in the     tailored intervention condition will have better utilization of and adherence to smoking     cessation pharmacotherapy, better mental and physical health, less perceived stress, greater     social support, less drug and alcohol use, and greater involvement in drug and alcohol     treatment than those in the control intervention condition; and (5) the newly created     tailored intervention will be feasible and acceptable. .   "
144473|NCT01393379|"     The purpose of this study is to investigate the effect of endoscopic valve implantation in     patients with COPD and PH on hemodynamics, symptoms, exercise tolerance and quality of life     in 10 patients in a prospective study. An improvement of objective parameters may also have a     prognostic significance   "
144474|NCT01393366|"     The investigators plan to conduct a nurse-based telephone intervention study to minimize     toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab     (FCR) given frontline to Chronic Lymphocytic Leukemia patients.   "
144475|NCT01393353|"     The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who     have a mild cognitive impairment or mild dementia. The control group is trained using     Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.   "
144476|NCT01393340|"     This pilot study is a double-blinded, randomized controlled, two-centre trial in which     subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or     placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE).     During the treatment period and follow-up, the clinical efficacy of the treatment will be     assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory     Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and     spirometry. Biological activity will be evaluated by measuring peripheral and local (in     serum, in nasal secretions, biopsies) markers of inflammation.      Study hypothesis        1. Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal          polyposis and comorbid asthma.        2. Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal          polyposis        3. Clinical assessment of the IgE theory in the pathogenesis of nasal polyps   "
144477|NCT01393327|"     Purpose of this study is to investigate whether and to what extent a cautious respiratory and     movement therapy can complement medical treatment and the condition, oxygen uptake, quality     of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk     distance in patients with pulmonary hypertension.   "
144478|NCT01393314|"     This is a randomized controlled trial of telemonitoring vs usual care provided by home care     agencies for atients with HF.      The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent     care visits, unscheduled physician appointments, ER visits in patients with heart failure     over the 60 day post hospitalization period.   "
144479|NCT01393301|"     During the 1-year formative phase of a study to develop an integrated treatment for quitting     smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up     activities will include piloting the integrated treatment on a small group of individuals (N     = up to 12), obtaining expert consultant and participant feedback, and development of the     final treatment manual and procedures. The goal during this phase will be to establish     feasibility of treatment delivery, participant acceptability, and potential for a treatment     effect before conducting a pilot randomized trial of the treatment. During the two-year pilot     RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral     and pharmacological smoking cessation intervention for HIV+ smokers with interfering     psychological distress.   "
144480|NCT01393288|"     Every year, more than 5 million patients in the US experience postoperative nausea and/or     vomiting (PONV) and in the ambulatory setting post-discharge nausea and/or vomiting (PDNV) is     the most common cause for unanticipated hospital re-admissions. Similarly, millions of     patients suffer from chemotherapy induced nausea and/or vomiting (CINV), and one out of five     patients discontinues chemotherapy for this reason. Thus, the control of nausea and vomiting     remains a major health concern for the investigators society. The investigatorsoverall goal     is to further the understanding of nausea and vomiting and optimize antiemetic selection in     order to facilitate individualized patient care.      Unfortunately, current antiemetics reduce the incidence of nausea by only about one third. As     a result, antiemetics are often combined, exposing patients to adverse events and drug     interactions without evidence for the most effective combination. Moreover, it remains     unclear why such a large amount of inter-individual variability exists in antiemetic     responsiveness. 5HT3, NK1, and GABA receptors are targets for some of the most commonly     prescribed anti-emetics. Furthermore, these receptors have many known genetic polymorphisms,     including several linked to incidence of nausea and vomiting. Thus pharmacogenomic variation     may in part explain interindividual differences in treatment responses and will be tested in     this proposal.      Leveraging the established infrastructure of the UCSF Clinical and Translational Science     Institute, and the support of 6 patient recruitment sites, the investigators will enroll 1280     high risk patients to three oral interventions with distinct mechanisms of action for nausea     and vomiting. Investigating nausea and vomiting in ambulatory surgical patients is an     excellent model for this trial owing to a high incidence, short observational period, and the     ability to standardize and control potentially confounding variables. In this proposal, 100%     of patients will receive a single intraoperative dose of 4 mg ondansetron, which is similar     to the 80% of patients who receive prophylaxis in common practice. Using a factorial design,     these patients will be randomized to receive one out of eight possible combinations of the     three interventions (ondansetron, aprepitant, lorazepam) versus placebo (ond+aprep+lora,     ond+aprep, ond+lora, aprep+lora, ond, aprep, lora, or placebo). Thus, in this proposal 87.5%     (7 out of 8 patients) will have antiemetic coverage for the postdischarge period, which is     considerably higher than in common practice, where only 4% of patients have antiemetic     coverage after discharge. The primary endpoint will be the prevention of nausea and vomiting     within 48 hours after ambulatory surgery. The advantage of the factorial trial design is its     high efficiency to systematically investigate multiple interventions while allowing us to     test for potential interactions. It is also an ideal format for the simultaneous assessment     of pharmacogenomic interactions of antiemetics in this proposal.      To this end, the investigators will collect DNA samples and take advantage of the unique     opportunity to investigate the effects of variation in candidate receptor genes in the     context of the three treatment interventions for PDNV. This approach may in part explain     inter-individual differences in drug efficacy and allow for future screening of at-risk     patients. Specifically, the investigators will be assessing single nucleotide polymorphisms     (SNPs) and copy number variants (CNVs) of targeted receptors for the antiemetics tested.      Aim 1: To determine efficacy of three interventions for the prevention of PDNV.      Hypothesis 1.1: Each intervention reduces the incidence of PDNV.      Hypothesis 1.2: Efficacy of all interventions is independent so that efficacy of a     combination can be derived from the efficacy of the individual interventions.      Aim 2: To determine if drug response for anti-emetics is dependent upon genetic variance.      Hypothesis 2: Efficacy of ondansetron, aprepitant and lorazepam to reduce PDNV differs with     5HT3, NK1, and GABA receptor gene variation, respectively.   "
144481|NCT01393275|"     The purposes of the study are        -  to determine if a supervised exercise intervention is improving the metabolic parameters          in type 2 diabetes patients        -  to investigate what kind of intervention (strength endurance training versus combined          strength endurance training and rehabilitation exercise intervention)is more effective          in improving the metabolic parameters in patients with type 2 diabetes        -  to assess which exercise intervention induces higher effects to the metabolic rate and          cardiac and pulmonary capacity        -  to investigate what kind of intervention includes highest effects in long term          persistence of these positive effects   "
144483|NCT01393249|"     The purpose of this study is to create a model enabling us to predict pancreatitis,     hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with     Acute Lymphoblastic Leukemia.   "
144485|NCT01393223|"     The purpose of this study is to assess the safety and tolerability of two doses of LP08     compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly     different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis     design will be employed, i.e. the measured outcomes will be subjects' improvements in     quantitative and qualitative measures of the disease condition being assessed prior to and     after LP-08 instillations at four and eight weeks follow-up visits   "
144486|NCT01393210|"     Obesity is an important health problem of modern civilization. In Western societies, almost     half of the adult population has problems with an increased body weight. Products containing     nutritional fiber has been used by humans for thousands of years. However, beta-glucan as     biologically active compound, present in these products, has been identified relatively     lately. This substance is a polymer of glucose and is present in two forms: 1,3D-1,6D and     1,3D-1,4D.      Water-insoluble beta-glucan (1,3D-1,6D) has immunomodulatory properties. The aim of the study     was the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie diet on     insulin sensitivity and the expression of selected proinflammatory cytokines in adipose     tissue and peripheral blood mononuclear cells (PBMC) in obese humans with normal glucose     tolerance.      The study group consisted of 40 subjects with marked overweight or obesity (body mass index,     BMI > 28 kg/m2), without serious concomitant diseases not taking drugs affecting glucose or     lipid metabolism, nonsmokers. Only volunteers, who gave written informed consent, after     receiving a full information about the aim and the design of the study, were recruited.      At the beginning of the study, after subjects' qualification to the project and before the     dietary intervention, the investigators performed:        -  anthropometric measurements.        -  oral glucose tolerance test.        -  euglycemic hyperinsulinemic clamp.        -  PBMC isolation before and after the clamp.        -  biopsy of subcutaneous adipose tissue before the clamp.        -  isolation of mRNA from PBMC and adipose tissue. Then, the expression of the selected          genes with the Real Time PCR was measured.        -  After the initial visit, participants received detailed instructions about low-calorie          diet, with the aim of reduction of 5-7% of body weight and the examples of menu for 14          days.      Then, participants were randomly assigned to a group receiving or not beta-glucan     preparation, as a addition to the low-calorie diet. Each group consisted of 20 subjects.     Subjects assigned to a group receiving beta-glucan, received the preparation (BETA GLUCAN     1,3-1,6 Laboratoria Natury 500mg) together with the detailed instruction of its usage. This     preparation is used as a non-prescription diet supplement, and the dose of 500 mg daily is     indicated by the manufacturer.      After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations     performed at the beginning of the study were repeated.   "
144487|NCT01393197|"     The purpose of this study is to evaluate the effects of Transcatheter Arterial     Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is     better,KMG microsphere or lipiodol?   "
144488|NCT01393184|"     Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence     indicates combination with EGFR Target therapy can bring benefit for the patients. Senile     Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable     treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of     the study Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of     Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN was sponsored to     evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN     patients.   "
144489|NCT01393171|"     The purpose of this study is to evaluate the success rate of cystocele repair using     polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a     prospective randomized fashion. The study will be performed in a randomized, prospective,     single-blinded fashion.   "
144490|NCT01393158|"     The purpose of this study is to obtain preliminary data regarding the safety and tolerability     of apremilast in AD to support the design of larger controlled studies.   "
144491|NCT01393145|"     A study multicenter, phase III, randomized, open label study to evaluate the efficacy and     safety of a fixed-dose combination of formoterol/fluticasone and salmeterol/fluticasone in     patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) that will     enroll 336 subjects aged ≥ 40 years, smokers or former smokers, diagnosed with chronic     obstructive pulmonary disease, classified as moderate chronic obstructive pulmonary disease     or severe according to GOLD spirometric classification. The subjects will be allocated in 2     parallel groups and will receive the medicines of study, according of the randomization     during a 24-week.   "
144492|NCT01393132|"     Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced     day-to-day function and significant discomfort. Tear substitutes are an important part of the     treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often     remains very irregular due to poor surface healing.      The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal     surface and has been studied in patients with recalcitrant corneal ulcers and erosions with     significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May,     2010).      The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface     healing, may be able to promote healing of the corneal surface allowing for more conventional     modalities to take over and maintain a smooth and regular ocular surface. The investigators     hope to be able to demonstrate an improvement in visual acuity, surface healing and a     reduction in dry-eye related symptoms.   "
144494|NCT01393106|"     This study will evaluate the efficacy and safety of idelalisib in participants with relapsed     of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall     response rate.      Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg     twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable     toxicity.   "
144495|NCT01393093|"     The purpose of the study is to evaluate the effects of Transcatheter Arterial     Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular     Carinoma(HCC).   "
144496|NCT01393080|"     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical     efficacy has been shown in adults with head and neck cancer. This study assesses the efficacy     and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy in     patients with NSCLC. This is a randomized, muti-center sites trial of this treatment.   "
144497|NCT01393067|"     Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic     liver transplantation. This study compares endoscopic treatment with implantation of multiple     plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).   "
144521|NCT01392755|"     This randomized, open-label study will evaluate the effect of food, and the effect of     omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be     assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of     danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of     omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.   "
144498|NCT01393054|"     Despite of the development of new anti hypertensive agents, hypertension in elderly is still     a big health problem. Nigella sativa seed extract, derived from a small plant originating in     Middle east which can be found abundantly in Asia, has shown small antihypertensive effect in     adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the effect     but as it also shows anti-inflammatory and vasodilatory activity which are important     contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it     has a superior potential benefit for this population. We will conduct a randomized, double     blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in elderly     patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract twice daily     will have anti-hypertensive effect in the blood pressure of elderly with hypertension.   "
144499|NCT01393041|"     The purpose of this clinical study is to assess device deployment characteristics and     performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6     French device utilizing the SJM collagen.   "
144500|NCT01393028|"     Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve     the workup of patients with stable chest pain complaints. The objective of the study is to     compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven     workup of suspected coronary artery disease in comparison to the standard workup using stress     testing.   "
144501|NCT01393015|"     Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver     automatically oxygen and to enable a remote medical monitoring with a homogeneous patient     population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation.      Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses     and medical personnel and there are advantages to use this system. In comparison with the     common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a     better control of the oxygen saturation in function of designed target, reducing the     desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical     way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse     personnel and to improve the support with centralized monitoring in the FreeO2 group.   "
144502|NCT01393002|"     This is a structured web-based survey in selected hospitals with intensive care units in     Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the field     of invasive mycoses.   "
144503|NCT01392989|"     Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a     treatment option for patients with Myelodysplasia or Myeloproliferative Disorders. During the     course of this study, we will attempt to learn whether a particular type of blood cell,     called a Cytokine Induced Killer (CIK) cell may add benefit to allogeneic stem cell     transplantation. CIK cells are present in small quantities in the bloodstream but their     numbers can be expanded after a brief period of nurturing in a laboratory.   "
144504|NCT01392976|"     The purpose of this study is to compare the pharmacokinetic and safety profiles of two     formulations of CO-1.01 in patients with Advanced Solid Tumors.   "
144505|NCT01392963|"     A 24-week Randomized, Double-blind study treating people who suffer from depression who also     have moderate to severe frown lines in forehead region with Botox injections. Subjects     participating will have their photos taken and complete a questionnaire regarding their     depression. They will see a psychiatrist at every visit who will assess their depression.   "
144506|NCT01392950|"     A clinical study report follows; this clinical study evaluated the safety and efficacy of     SAUFLON CLARITI Soft Silicone Hydrogel Contact Lens with UV Blocker by comparison with Air     Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.).      Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens     maintenance, care and storage.   "
144507|NCT01392937|"     A clinical trial was conducted to assess the safety and acceptability of the Sauflon     Multipurpose Solution when used with four different silicone hydrogel contact lens brands and     one conventional hydrogel control lens was conducted over a period of two months, with a     control group using Ciba Vision Aquify Multi- Purpose Solution. The study was conducted at     six investigator sites and a total of 257 subjects were enrolled. The results of this study     showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose     Solution to the predicate device for its intended use.   "
144508|NCT01392924|"     Primary Objective:      - To confirm safety and tolerability of global recommended phase three dose (RPTD) of     SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with     solid tumors.      Secondary Objectives:        -  To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408          in CDD treatment schedule in patients with solid tumors.        -  To gather preliminary efficacy data after repeated administration of SAR245408 in          patients with solid tumors.   "
144596|NCT01391754|"     The study is a field trial comparing the SafeCare family preservation model to a comparable     usual care model for parents in child welfare. The study also compares two levels of service     quality control.   "
144509|NCT01392911|"     This is the first trial in a series of clinical trials that aim to bring the concept of high     dose rifampicin beyond phase II of clinical development.      The safety, tolerability, extended early bactericidal activity (EBA) and pharmacokinetics of     several doses of Rifampicin with or without standard doses of Isoniazid, Pyrazinamide and     Ethambutol in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB will     be assessed. The objective of this study is to find the maximum tolerable dose of Rifampicin     as monotherapy and in combination with the currently available Isoniazid, Pyrazinamide and     Ethambutol.      The subjects will be in the study for 24-31 days. After a screening period of 9-3 days, the     subjects will receive treatment with Rifampicin as single drug during 7 days (monotherapy).     This treatment will be followed by treatment with 7 days of Rifampicin and Isoniazid,     Pyrazinamide and Ethambutol (combination therapy), and 7-8 days treatment with standard TB     medication.      All subjects will be closely monitored for side effects. This monitoring will include daily     interviews and physical examination, and ECG evaluation and blood and urine analyses at     specific intervals.      During the 7 days of monotherapy, after the second day of the combination therapy and at the     end of the combination therapy, overnight sputum will be collected from the patients to     investigate the potency of high dose rifampicin to reduce this number of bacilli.      The Rifampicin dose will be increased step by step and group by group. The control group will     receive the standard dose of 10 mg Rifampicin/kg, whereas the first treatment group will     receive 20 mg/kg. The Rifampicin dose will only be further increased for a next group of     patients, if this is expected to be safe.      Rifampicin is widely available and not expensive. Physicians all over the world have     experience with this drug and its adverse effects. Should this study be successful, the     highest dose of Rifampicin that this safe and tolerable will be given to a larger group of     patients. in the next study.      If increasing the dose of Rifampicin proves to be safe and effective, a higher dose of     Rifampicin could be implemented broadly and quickly, and it would benefit many patients     worldwide.   "
144510|NCT01392898|"     Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2     diabetes. Although insulin is an effective treatment modality, this is often at the expense     of significant weight gain. Weight gain is obviously undesirable in an already overweight     population, but may also deter further optimization of insulin therapy. Large     inter-individual differences exist in the level of weight gain after initiation of insulin     therapy, but no clear predictive factors have prospectively been identified thus far.      Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic     control and reduces weight. We hypothesize that in patients who show (excessive) weight gain     after introducing insulin therapy, adding liraglutide is effective in reversing body weight     while preserving glycaemic control.   "
144511|NCT01392885|"     To determine the effects of aerobic exercise on hippocampal volumes and severity of psychotic     symptoms in a population of psychosis patients compared to healthy age/gender matched     volunteers. Psychosis patients often suffer from a number of cognitive difficulties,     including poor memory function, poor problem-solving capacity and difficulties with attention     and concentration. These problems are not well addressed by current clinical treatments.     Evidence from aging research strongly suggests that increased cardiovascular fitness may     provide numerous cognitive benefits by promoting brain growth, particularly in the frontal     lobes and the hippocampi. The current study will measure the effects of aerobic exercise on     brain volumes in a population of chronic psychosis patients to determine if 1) hippocampal     volumes increase in response to exercise and 2) if parallel improvements in cognitive     functioning occur.   "
144512|NCT01392872|"     Multiple Sclerosis is the first cause of neurological handicap in France. The importance of     cognitive disabilities, their evaluation and their impact on patients' life have only been     comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS)     but imply a lot of constraints. This study will evaluate the impact of these treatments on     cognitive disabilities, tiredness state, emotion and quality of life in general, on a     lengthened period.   "
144513|NCT01392859|"     Asthma, a chronic disease which produces significant morbidity and mortality in children, is     a significant health problem to a large segment of society. Despite considerable advances in     the diagnosis and treatment of asthma over the past several years, a sizeable portion of     patients do not respond to the core treatments. The investigators are now learning that the     underlying pathophysiology of disease is different among patients with asthma therefore;     treatments which are beneficial in some patient groups may be not achieve affect in other     groups.      Antihistamines have been studied in the past for the treatment of asthma. These studies have     shown that there may be a beneficial effect of antihistamines in patients with allergic     asthma where histamine likely plays a large role in disease and treatment response. However,     there is not enough evidence to include these drugs in the standard treatment of asthma.      The investigators hypothesize that histamine plays a definable, significant role in disease     pathogenesis and treatment response in children with allergic asthma. The investigators plan     to test this overall hypothesis through two specific aims. The first aim will characterize     the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be     accomplished by comparison of the microvasculature response to histamine in children with     allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis     with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences     in the pharmacodynamic response to histamine. The investigators will also investigate the     role of genetic variation in the observed differences in HILD between the two groups. The     second aim will characterize the pharmacodynamic response to antihistamines via HILD in     children with an exaggerated histamine response compared to children with a low histamine     response. This aim will be accomplished through conduct of a randomized, double-blind,     placebo-controlled cross-over trial of levocetirizine (LCT) in the two groups (high histamine     and low histamine) and observing the difference in antihistamine pharmacodynamics in the two     groups. The investigators will also investigate the effect of pharmacokinetic variation and     genetic variation in the histamine pathway on the observed pharmacodynamic drug response.   "
144514|NCT01392846|"     This is a prospective, observational, cohort study to evaluate the relative efficacy and     safety of Resolute Integrity stent compared to other (drug eluting stents) DES.   "
144515|NCT01392833|"     Some years ago the investigators designed a randomised trial to prospectively evaluate     whether adding low-dose azathioprine (1.5 mg/kg/day for six months) to steroids     (methylprednisolone 1 g i.v. for three consecutive days at months 1, 3 and 5, plus oral     prednisone 0.5 mg/kg every other day for six months) can improve long-term renal survival in     adult IgAN patients with proteinuria higher than 1g/24 hours and plasma creatinine <=2.0     mg/dl.      In order to test the efficacy of the combination of steroids with azathioprine at various     degree of renal function deterioration by extending the trial to patients with more advanced     disease (serum creatinine higher or equal to 2 mg/dl) without any time limit for renal     biopsy. Treatment will last one year: methylprednisolone 1 g i.v. for three consecutive days     at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day     for six months, then 0.2 mg/kg every other day for further 6 months. The primary outcome was     renal survival (a 50% increase in plasma creatinine from baseline); the secondary outcomes     were proteinuria over time and the number and types of adverse events in the two groups     assessed every month for the first six months, every two months from the 6th to the 12th     month and every three months thereafter. The planned duration of follow up is five years.   "
144516|NCT01392820|"     The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214     in elderly healthy Japanese volunteers.   "
144517|NCT01392807|"     The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with     impaired hepatic function versus subjects with normal hepatic function.   "
144518|NCT01392794|"     A study to compare time-course changes of plasma concentration of YM060 after intake of     conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be     administered without water.   "
146574|NCT01365754|"     The purpose of this study is to compare posterior dynamic stabilization with fusion in the     treatment of lumbar degenerative disease.   "
144519|NCT01392781|"     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of     anovulatory infertility among reproductive aged women. According to the revised criteria of     2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging evidence     supporting the existence of different levels of cardiometabolic risk between the four     phenotypic groups of the syndrome. The purpose of this study is to determine the     cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the     four phenotypes of the syndrome as well as the levels of low inflammation serum markers and     the possible correlations of the between the outcomes.   "
144520|NCT01392768|"     The purpose of this study is to determine whether levetiracetam as adjunctive therapy is     effective in the treatment of partial seizures, with or without secondary generalization,     associated with refractory focal epilepsy.   "
144522|NCT01392742|"     This observational study will evaluate predictors of early on-treatment response and     sustained virological response in patients with chronic hepatitis C receiving Pegasys     (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24     or 48 weeks) and 24 weeks after the end of treatment.   "
144529|NCT01392651|"     Women with urinary stress incontinence who underwent surgical treatment by either TVTO or     TVTS will be enrolled. The investigators will collect data from charts and use a telephone     questionnaire to check the outcome of these women. Physical examination findings will also be     incorporated.   "
144530|NCT01392638|"     Sildenafil citrate slightly reduces blood pressure in treated hypertensives patients.     However, it is unknown if the simultaneous use of sildenafil plus, at least, 3 classes of     antihypertensive agents in patients with resistant arterial hypertension may have a synergic     effect on the patients blood pressure. Moreover, sildenafil improves the endogen nitric oxide     effects. The nitric oxide is an important signaling molecule in the body that contributes to     vessel homeostasis by inhibiting vascular smooth muscle contraction and growth. Hypertension     often impaired NO pathways. Nitric oxide is produced by an enzyme, called nitric oxide     synthase (NOS3), that show some genetics variants, which means that this enzyme can be     different from person to person. Therefore, the objective of the present study is to examine     the influence of a genetic variant (known to affect NOS3 levels) in sildenafil acute effects     on hemodynamic and cardiovascular function. The investigators hypothesis is that individuals     with the genetic variant associated to higher levels of NOS3 will have more benefits from     sildenafil treatment.   "
144531|NCT01392625|"     The technique of transplanting progenitor cells into a region of damaged myocardium, termed     cellular cardiomyoplasty1, is a potentially new therapeutic modality designed to replace or     repair necrotic, scarred, or dysfunctional myocardium2-4. Ideally, graft cells should be     readily available, easy to culture to ensure adequate quantities for transplantation, and     able to survive in host myocardium; often a hostile environment of limited blood supply and     immunorejection. Whether effective cellular regenerative strategies require that administered     cells differentiate into adult cardiomyocytes and couple electromechanically with the     surrounding myocardium is increasingly controversial and recent evidence suggests that this     may not be required for effective cardiac repair. Most importantly, transplantation of graft     cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a     number of candidate cells have been transplanted in experimental models, including fetal and     neonatal cardiomyocytes5, embryonic stem cell-derived myocytes6, 7, tissue engineered     contractile grafts8, skeletal myoblasts9, several cell types derived from adult bone     marrow10-15, and cardiac precursors residing within the heart itself16. There has been     substantial clinical development in the use of whole bone marrow and skeletal myoblast     preparations in studies enrolling both post-infarction patients, and patients with chronic     ischemic left ventricular dysfunction and heart failure. The effects of bone-marrow derived     mesenchymal stem cells (MSCs) have also been studied clinically.      Currently, bone marrow or bone marrow-derived cells represent highly promising modality for     cardiac repair. The totality of evidence from trials investigating autologous whole bone     marrow infusions into patients following myocardial infarction supports the safety of this     approach. In terms of efficacy, increases in ejection fraction are reported in the majority     of the trials.      Non-ischemic dilated cardiomyopathy is a common and problematic condition; definitive therapy     in the form of heart transplantation is available to only a tiny minority of eligible     patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for     acute MI, but represents a potentially important alternative for this disease.   "
144532|NCT01392612|"     We hypothesized that the effect of erythropoietin may be reflected by changes in thromboxane     B2 (TXB2) and endothelial cell function.      Six male and six female subjects received recombinant human epoetin alpha (Erypo®)     intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48     and 72 hours after administration.   "
144533|NCT01392599|"     The purpose of this study is to investigated and evaluated the effectiveness of a new     surgical technique for the treatment of severe chronic pain stages (Complex Regional Pain     Syndrome Type II).   "
145814|NCT01375777|"     The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG     145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change     from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.   "
144534|NCT01392586|"     SUBMIT is a clinical trial that intends to answer the question whether up front breast     surgery in patients with primary distant metastatic breast cancer will result in an     improvement of the 2-year survival compared to the survival achieved with systemic therapy     and delayed local treatment or systemic therapy alone.      Randomization will take place immediately after the diagnosis of primary distant metastatic     breast cancer. Patients either randomize for up front surgery of the breast tumor (UFS)     followed by systemic therapy or for systemic therapy (ST) potentially followed by delayed     local treatment of the breast tumor.      The primary endpoint of this trial is the 2-years survival. Quality of life is one of the     most important secondary endpoints.   "
144535|NCT01392573|"     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of     this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira)     and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their     pre-trial treatment with metformin throughout the entire trial.   "
144536|NCT01392560|"     This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular     filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects     with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the     safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.   "
144537|NCT01392547|"     This trial is conducted globally. The purpose of this trial is to confirm the efficacy and     safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.   "
144538|NCT01392534|"     One of the most common adverse effects resulting from the therapy with thiazides,     thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of     plasma potassium may be a life-threatening condition due to increased risk of arrythmias.     Moreover, it has been postulated that decrease in plasma potassium level may negatively     affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The     main goal of this study is to assess the efficacy and safety of     telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the     effects of the therapy on plasma potassium level and also on selected parameters of glucose     and lipid metabolism.   "
144579|NCT01391975|"     Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the     blood vessels. Methods of detecting narrowing are available and, more importantly, can detect     narrowings before a fistula fails. It is not known whether treating these narrowings will     actually improve fistula survival or if the majority can be left alone. we wish to see if we     can detect such narrowings with ultrasound scanning and if early detection and treatment     improves patient outcomes.   "
144881|NCT01388023|"     In a previous study the prevention of halitosis by the herbal formula and delivery system     (SmellX), were established both in vitro and clinicaly. The duration of relief was     established as long as 8 hours. In this study the investigators intend examine the day long     efficacy of SmellX.   "
144539|NCT01392521|"     The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated     protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent     treatments in other phase I studies. This study will test the combination of these two drugs     to try and answer the following questions:        1. What are the side effects of the combination of Copanlisib and Refametinib          (BAY86-9766)when given together at different/increasing dose levels?        2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future          clinical research studies?        3. How much Copanlisib is in the blood at specific times after administration and does          adding Refametinib (BAY86-9766) have an affect?        4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration          and does adding Copanlisib have an affect?        5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on          tumors?   "
144540|NCT01392508|"     The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used     as a marker of severe sepsis (including septic shock) in patients presenting to the emergency     department with suspected infection.   "
144541|NCT01392495|"     This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety,     tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension     patients.   "
144542|NCT01392482|"     Multicentre, retrospective observational cohort study based on LHU administrative databases     aimed to described the pharmacoutilization of antipsychotics in patients affected by     schizophrenia and bipolar disorder, the resource consumption and medication adherence. A sub     analysis will be performed for those patients switching from Quetiapine IR to Quetiapine XR     and comparing the periods before and after the switch.   "
144543|NCT01392469|"     This study will investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan     and sildenafil at steady state when co-administered to pulmonary arterial hypertension     patients.   "
144544|NCT01392456|"     The aim of the study is:        1. To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in          Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by          Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient          instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.        2. To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with          implant-supported overdentures with three different types of retention: Retentive          Anchors, Magnets, Locator.   "
144545|NCT01392443|"     The objective of this study is to determine the efficacy of INC424 as assessed by reduction     in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF,     or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the     effects of INC424 on patient reported outcomes and the duration of response as assessed by     reduction in spleen volume will also be assessed.   "
144546|NCT01392430|"     The purpose of this study is to compare the incidence of opportunistic infections between     HIV-infected patients who continue and discontinue primary or secondary prophylaxis for     opportunistic infections in whom receiving combination antiretroviral therapy and achieve     undetectable HIV-1 RNA, but CD4 cell counts are less than 200 cells/mm3.   "
144547|NCT01392417|"     Women who had surgery for pelvic floor prolapse underwent surgery by anterior Prolift or     Posterior prolift at least a year after the surgery.      The data from the charts and from telephone conversations with the patients will be entered     to a database. Physical examination data will also be incorporated.   "
144548|NCT01392391|"     Chronic hemiparetic stroke is associated changes in body composition, skeletal muscle and     cardiometabolic health; specific changes include paretic limb muscular atrophy, increased     intramuscular fat deposition, elevated prevalence of impaired glucose tolerance and type 2     diabetes. This randomized intervention study compares a 6 month task oriented exercise     programs versus control with both groups receiving best medical stroke care according to     American Stroke Association Get with the Guidelines. The hypothesis is that is 6 months of     task-oriented exercise initiated early across the sub-acute period of stroke can prevent or     ameliorate the natural course of these body composition, skeletal muscle and cardiometabolic     health changes.   "
144549|NCT01392378|"     The purposes of this study are assess the immunological response (measure the amount of     antibodies, i.e. proteins that fight off germs) produced by children after they have been     given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months     of age when medications to prevent fever are given on the same day as the vaccination. Also     to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who     receive medications to prevent fever on the day of vaccination.   "
144550|NCT01392365|"     The aim of this study is to develop a scoring system and a prediction model for differential     diagnosis between intestinal tuberculosis and Crohn's disease.   "
144551|NCT01392352|"     Pazopanib is a new cancer drug that works by limiting the growth of new blood vessels in     tumours. About half of patients who take pazopanib develop high blood pressure     (hypertension). This side effect can make patients have to reduce or stop their cancer     treatment, and can cause other health problems. The aim of this study is to find out exactly     how the drug causes high blood pressure.   "
144552|NCT01392339|"     Obstructive sleep apnea is a multi-component disease. This study will test the hypotheses     that hypoxia per se modulates gene expression in animal model of sleep apnea and these     results may be translated with alterations that occur in apneic patients. Thus, we aim to     integrate basic and clinical research to shed light on novel candidate genes involved in     sleep apnea.   "
144553|NCT01392326|"     This study will assess the efficacy and safety of secukinumab in patients with active     psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,     DMARDs and / or TNFα inhibitor therapy.   "
144554|NCT01392313|"     The investigators will measure renal function in subjects ingesting carnitine to determine if     the product alters renal function.   "
144555|NCT01392300|"     The purpose of this study is to determine whether injections of Botulinum toxin type A into     muscles of the upper limb are effective in treating spasticity in patients after stroke.   "
144897|NCT01387815|"     The current study will compare the real - life effectiveness of adalimumab to topical and     traditional systemic agents in the management of psoriasis and its impact on the patient's     quality of life and societal burden of illness.   "
144556|NCT01392287|"     This study involves collaboration between McLean Hospital, Geriatric Medicine at the     Cambridge Health Alliance (CHA) and other sites within the Partners and Harvard Medical     School network. The investigators plan to recruit individuals 55 to 89 years old with     treatment resistant depression. Someone with treatment resistant depression for this study     may be someone who still has sad or low feelings and thoughts even though he/she is taking an     antidepressant medication for at least 8 weeks to help relieve his/her depression. During the     study, subjects will gradually add memantine hydrochloride in dosages up to 20 mg/day for 8     weeks to their standard antidepressant treatment.      The investigators are doing this research study to help answer 3 questions:        1. Do older adults with treatment resistant Major Depression have lower levels of a          chemical in the brain called NAAG than older adults without Major Depression?        2. Do older adults with naturally low NAAG levels do better on memantine hydrochloride          treatment than older adults with higher amounts of this chemical on memantine          hydrochloride treatment?        3. Do older adults with treatment resistant depression have more problems with memory and          concentration than older adults without depression?      The investigators are also interested in looking at electrical and neuronal activity of the     brain, spiritual beliefs, and fatigue in relationship to depression.      The investigators hypothesize that:        1. Older individuals with treatment resistant Major Depression will have lower levels of          NAAG compared with age-matched older control subjects.        2. Older adults with treatment resistant depression and low NAAG levels will do better on          treatment with memantine hydrochloride than older adults on memantine with higher NAAG          levels.        3. Older adults with depression will do better on tests of attention and executive          functioning after treatment with memantine hydrochloride.        4. Healthy controls will do better on tests of attention and executive functioning than          older adults with depression.   "
144557|NCT01392274|"     This study will collect data from patients undergoing an ERCP procedure with probe-based     Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate     the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when     associated with other diagnostic information (standard ERCP and tissue sampling).   "
144558|NCT01392248|"     1. Rationale The inter-individual pain experience immediately after surgery is          considerable. In addition, a number of patients develop chronic post surgery pain          (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both          acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic          back pain, it was demonstrated how subjectively reported pain is associated with          specific electroencephalography (EEG) parameters, namely the N2 and P3 components of the          pain event-related potential (ERP). It was concluded that ERP was associated with          self-reported pain in daily life up to two weeks after the measurement. This resulted in          the current hypothesis that EEG may be a predictor for postoperative pain.        2. Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will          undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be          repeated 6 months postoperatively.           Study population: Female patients with breast cancer who will undergo breast surgery,          between the ages of 18 to 65 years.        3. Main study parameters/endpoints Primary outcome is postoperative pain, measured in a          pain diary 4 days postoperatively. Secondary outcomes are development of chronic post          surgery pain and quality of life. The main goal is to develop a comprehensive prediction          model for acute and chronic postoperative pain after breast cancer surgery, based on the          EEG results of the five vulnerability experiments.   "
144559|NCT01392235|"     RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,     Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.      PURPOSE: This phase II trial is studying how well famitinib works in treating patients with     recurrent and/or metastatic NPC.   "
144560|NCT01392222|"     The purpose of this study is to understand more about why some patients choose to have     surgery to treat their papillary microcarcinoma (PMC) and others choose to have their     papillary microcarcinoma (PMC) regularly watched by their doctor to see if and when they may     need surgery (referred to as active surveillance). The investigators also hope learn more     about what patients and their family members worry about or feel they will gain from surgery     or active surveillance.   "
144561|NCT01392209|"     The best dose of radiation to be given with bevacizumab is currently unknown. This study will     use higher doses of radiation with bevacizumab than have been used before. This study will     test the safety of radiation given at different doses with bevacizumab to find out what     effects, good and/or bad, it has on the patient and the malignant glioma or related brain     cancers.   "
144562|NCT01392196|"     This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary     aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe     and determine the evidence of a response to renal denervation in patients with Heart Failure.   "
144764|NCT01389544|"     This multicenter, open-label study will assess the effect of multiple doses of     danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable     methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive     danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.   "
144563|NCT01392183|"     The goal of this clinical research study is to compare pazopanib to temsirolimus in the     treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be     studied.      Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for     tumor growth. This may prevent or slow the growth of cancer cells.      Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to     die.   "
144564|NCT01392170|"     The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a     (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of     this treatment combination will also be studied.      Pegasys is a form of the drug interferon. It is designed to help the body's immune system to     fight infections. It may also affect the body's response to cancer.      A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a     protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from     growing, and may cause them to die.      You are already receiving a TKI. This consent form will describe the administration of     Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys,     and any risks/benefits there may be from receiving Pegasys.   "
144611|NCT01391559|"     Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are     uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One     possible explanation is that the patient is unable to inhale the dry powder bronchodilator     medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A     PIFR < 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device.     The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured     at two hours after inhalation of the study medication will be higher with arformoterol     solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from     the Diskus.   "
144565|NCT01392157|"     The main side-effect of Implanon is the changes induces in bleeding patterns including     amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any     previous symptom and it was characterized as breakthrough bleeding (BTB). BTB is the main     causes of early discontinuations. Unfortunately, there is no indication to predict prior to     insertion what sort of bleeding pattern any individual woman may have after insertion and the     proposed treatments were disappointed. Nevertheless, previous studies with other     progestin-only contraceptives (including Implanon) provide evidence that the provision of     adequate and intensive counseling to potential users and new acceptors about bleeding changes     can help to improve method continuation.      The availability of Implanon in the public sector could help in the development of strategies     to introduce the method in the public sector network and the training of medical residents.   "
144566|NCT01392144|"     The goal of this clinical research study is to learn if the level of nitric oxide you breathe     out may relate to the amount of breathing complications that you may experience due to     radiation treatment.   "
144567|NCT01392131|"     Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma   "
144568|NCT01392118|"     The purpose of this study is to investigate the risk factor, molecular character and     susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia   "
144569|NCT01392105|"     Early reperfusion strategies in tandem with remarkable advances in drugs and devices for     treating myocardial infarction (MI) have contributed to a reduction in early mortality, but     cardiovascular disease remains the leading cause of death worldwide. Current management     strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart     failure. In this respect, stem-cell therapy has shown potential benefits for repairing the     damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive     therapeutic candidates because of their high capacity for replication: paracrine effect:     ability to preserve potency: and because they do not cause adverse reactions to allogeneic     versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but     only one clinical trial using MSCs via the intracoronary route in the setting of acute     myocardial infarction (AMI) has been carried out. The investigators therefore assessed the     safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in     patients with AMI.   "
144570|NCT01392092|"     N-acetylcysteine (NAC) is a medication that the Food and Drug Administration (FDA) has     approved for several medical uses, such as dissolving mucus in patients with breathing     problems, treating overdose from acetaminophen (Tylenol), and protecting the kidneys from     toxic substances.      Some recent studies suggest that NAC could be useful in the treatment of other disorders     including addictions. One purpose of this study is to determine whether NAC alters the level     of brain glutamate (a chemical that excites brain cells). The other main purpose is to     determine whether NAC affects how much cocaine people use.   "
144571|NCT01392079|"     Aims and objectives        -  Assessment of the efficacy of the study treatment in the study population in terms of          response rate, progression-free survival, failure-free survival and overall survival.        -  Acquisition of further data to expand the data base on the toxicity of the study          treatment.        -  Assessment of the efficacy of the study treatment in biological risk groups.        -  Assessment of response in terms of minimal residual disease. Number of patients and          estimated duration Total no. of patients: 122 (~29 with 17p deletion for first-line          therapy, ~29 with 17p deletion for second- or higher-line treatment, ~65          fludarabine-refractory irrespective of 17p status).      Duration for each patient: Max. 12 weeks of treatment in three 4-week cycles, then up to two     years maintenance treatment.   "
144572|NCT01392066|"     The purpose of this study is to describe psychosocial adjustment in patients with breast     cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study     mutual influences of the partner on the patient and vice versa, and to identify risk and     protective factors that influence the adjustment process in both patients and partners. The     overall aim is to generate knowledge that helps enables us to integrate the partners' needs,     problems and resources in treatment and rehabilitation of breast cancer patients.   "
144573|NCT01392053|"     The objective of this research is to evaluate the effect of massage therapy as a resource for     pain relief during the active phase of labor. The research will be of type randomized     controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral     Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups     (lumbosacral massage) and control (routine maternity) and will be assessed before and after     therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation     will be performed by numerical category scale, Diagram Location of Pain and Pain     Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction     questionnaire.   "
144574|NCT01392040|"     The purpose of this study is to determine whether the new algorithm is safety and effective     in proposing the dosage and the timing of oral anticoagulant therapy.   "
144575|NCT01392027|"     This proposed project is designed to collect data and specimens from patients/subjects     presenting to the University of Michigan with a disease affecting the pancreas (or specific     control populations). This protocol is focused on collecting data, blood samples, and tissue     on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts,     pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy     controls.      We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy     coat are collected and stored according to strict SOPs.   "
144576|NCT01392014|"     Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping     malaria transmission.The addition of primaquine (PQ) - the only drug commercially available     that kills mature transmission stage - to such treatments might be necessary to eliminate     this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine     (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in     Sumatra, Indonesia.   "
144577|NCT01392001|"     This observational study will evaluate the glucocorticoid sparing effect after 12 months of     treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data     will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from     patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 months     .   "
144580|NCT01391962|"     Background:        -  Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less          than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients          with metastatic ASPS. Little is known with regards to relevant molecular markers as          potential therapeutic targets.        -  Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of VEGF          receptor tyrosine kinases, are showing preliminary evidence of activity in patients with          ASPS.      Objectives:        -  Part I: Determine the objective response rate (ORR) of single-agent cediranib and          single-agent sunitinib malate in patients with advanced ASPS.        -  Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm,          and determine the ORR of sunitinib in patients who progress on the cediranib arm.        -  Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and      single-agent sunitinib malate in patients with advanced ASPS.      Eligibility:        -  Patients aged greater than or equal to 16 years with histologically or cytologically          confirmed metastatic ASPS.        -  Patients must show evidence of objective disease progression per RECIST 1 on scans          within the 3-month period immediately preceding enrollment. Both scans used to determine          disease progression should have been obtained within this 6-month period.        -  Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show          clinical evidence of disease progression will be eligible.        -  Patients must not have received treatment with any VEGF receptor tyrosine kinase          inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment          with bevacizumab is allowed.      Design:        -  Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate          (37.5 mg) orally, once a day in 28-day cycles.        -  Part II: At the time of disease progression, patients will cross over to the other          treatment arm after a 2-week wash-out period.        -  Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles          for restaging.        -  The study will be conducted using an optimal two-stage design to rule out an          unacceptably low 15% clinical response rate (PR+CR) in favor of a modestly high response          rate of 40%.      The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10     patients has a clinical response, then no further patients will be accrued. If 2 or more the     first 10 patients have a response, then accrual continues to a total of 22 patients in each     arm.   "
144581|NCT01391949|"     This purpose of this study is to determine the effect of different levels of feedback on     participation in a home exercise regimen and the amount of walking performed by patients     recently discharged from the acute rehabilitation setting.   "
144582|NCT01391936|"     Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon     fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence     regarding the optimal treatment and outcome of these fractures with only one prospective     randomized trial (1992) in the literature comparing tension band wire and plate fixation for     displaced olecranon fracture. Our trial includes all patients under the age of 75yrs     presenting to the Edinburgh Orthopaedic Trauma Unit with an isolated olecranon fracture     requiring operative intervention. Patients who consent to enrol in the trial will be     randomised to operative fixation using one of two recognised fixation techniques - tension     band wire fixation or plate fixation. Patients will be evaluated over a one year period     following their surgery.   "
144583|NCT01391923|"     This study is being performed to reduce unwanted fat in the arm using a new applicator for     the Zeltiq System.   "
144584|NCT01391910|"     The aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as     measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the     significance of response shift on treatment effect.      This is a prospective cohort study. The investigators will recruit patients who are within a     6 month post-functional endoscopic sinus surgery (FESS) timeframe and completed a     pre-operative SNOT-20. The investigators will ask subjects to complete two more SNOT-20 forms     and a Transition Quality of Life (QOL) scale. The SNOT-20 forms will be labelled pre and     post operative. The pre should be completed based on subject's memory of their condition     prior to surgery and post based on how they feel now.   "
144585|NCT01391897|"     This reported observational clinical study aims at identifying epigenetic markers in a sample     of patients undergoing high dose inpatient psychotherapy suffering from a variety of     psychiatric/psychosomatic diseases such as somatoform disorders, posttraumatic stress     disorder (PTSD), depression, anxiety disorders and eating disorders.      The exact epigenetic markers that will be traced are yet to define.      The investigators believe that        1. Epigenetic patterns found in the group of psychiatric patients show differences from          healthy controls        2. Different diagnosis show differences in epigenetic patterns as well        3. Epigenetic patterns correlate to the severity of the psychosocial disorder as measured          in interviews or psychometric ratings        4. Epigenetic patterns can change under inpatient high dose psychotherapy        5. Changes correlate to clinical psychometric variables.   "
144628|NCT01391325|"     This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the     safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy     (ULT) for up to six months. Allopurinol will be dosed according to the local product label,     at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for     each patient.   "
144586|NCT01391884|"     The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is characterized     by a severely impaired incretin effect. The incretin effect refers to the insulinotropic     action of the nutrient-released incretin hormones glucagon-like peptide-1 (GLP-1) and     glucose-dependent insulinotropic peptide (GIP). The incretin effect is defined as the     difference in insulin secretory responses between oral and isoglycaemic intravenous glucose     challenges (OGTT and IIGI, respectively) and in healthy individuals it accounts for as much     as 70% of the insulin response following oral glucose, whereas patients with T2D exhibit an     incretin effect in the range of 0 to 30%. Patients with T2D and non-diabetic patients with     severe kidney failure share several pathophysiological characteristics, including decreased     insulin sensitivity, fasting hyperinsulinaemia and impaired beta-cell function. The reason     for these findings remains to be fully elucidated. An ongoing study in our research group is     investigating the incretin effect and the incretin hormone secretory responses following     OGTT, IIGI and meal ingestion, respectively. In continuation of this study, essential     knowledge of metabolism of incretin hormones in an uremic milieu will be obtained in the     present study prior to evaluation of the use of incretin-based agents in patients with     impaired kidney function. In this second study we evaluate the elimination and biodegradation     of GLP-1 and GIP. The biological active incretin hormones are rapidly degraded by the     ubiquitous enzyme dipeptidyl peptidase-4 (DPP-4), generating inactive metabolites. The active     hormones are however also eliminated by renal clearance, although the importance of this     remains questionable. It is likely that the degradation and elimination of the active     hormones will be significantly affected in patients with severe kidney impairment.      We hypothesize that elimination and biodegradation of the two incretin hormones, both in it´s     active and inactive forms, will be affected in non-diabetic patients with severe kidney     failure.   "
144587|NCT01391871|"     The purpose of this study is to compare vascular healing of the stented segment after     deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting     stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.   "
144673|NCT01390740|"     Study of the prevalence of Abdominal Aortic Aneurysms (AAA) (> 3 cm) in patients with     echocardiography (transthoracic or) during a specific day, with cardiologists in France.      This is a cross-sectional epidemiological investigation, assembling evidence from a routine     ultrasound screening for AAA at the waning of echocardiograms performed during a specific     day.      The study will be offered a list of centers selected by the Scientific Committee in the     complete list of locations being in France, the subsidiary of echocardiography     Echocardiography of French Society of Cardiology. These centers will be 500 in number     representative of the French centers, geographically and by type of centers.   "
144588|NCT01391858|"     This study will compare the effects of oral pregabalin with placebo on postoperative pain and     morphine usage after mastectomy.      Pregabalin is an anticonvulsant agent approved by the United States Food and Drug     Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic     neuralgia and diabetic neuropathy.      Women 18-70 years of age, undergoing unilateral modified mastectomy or lumpectomy with     axillary node dissection will be recruited to participate in the study. Patients unable to     cooperative, those that have known allergy to pregabalin or morphine and a history of drug or     alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, or impaired     kidney function will all be excluded from the study. A pregnancy test will also be performed     to exclude pregnant women from the study.      Oral pregabalin 300 mg (or placebo) will be administered to patients 1-2 hours before surgery     followed by 150 mg 12 hours later. Thereafter, 150 mg of oral pregabalin (or placebo) will be     administered twice daily until day 14. Whether a patient receives pregabalin or placebo will     be decided based on a process similar to tossing a coin.      Patients will receive a standard general anesthetic for their operation and will receive     intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate     postoperative period. Oral opioids will be administered after discontinuation of the PCA.      Subjects will be visited after the operation while in the hospital and intermittently for     three months at the outpatient clinic after discharge from the hospital. Subjects will be     asked to return remaining study drug/empty container when they are at the hospital for their     2 week follow up visit.      Potential adverse effects of pregabalin include dizziness, somnolence, peripheral edema,     weight gain, headache, dry mouth, blurry vision, and ataxia. The incidence of these side     effects occurring ranges variously between 1 and 25%. Investigators will closely monitor all     patients for the occurrence of these side effects.   "
144589|NCT01391845|"     Controlled ovarian stimulation (COS) for FIV increases progesterone (P) and estradiol (E2)     serum levels in supraphysiologic concentrations at the end of follicular phase. Elevated     serum P levels leads to an accelerated endometrial maturation which interferes with the     dialogue between embryo and endometrium. It has been reported that serum progesterone levels     ≥ 1.5 ng/ml on the last day of COS are related to a significant decrease in the ongoing     pregnancy rate following IVF cycles. Also, it has been reported a significant alteration in     the endometrial gene expression profile related to P elevated levels.      Glycodelin-A is an immunomodulatory glycoprotein synthesized by luteal-phase endometrial     epithelium and its expression seems to be related to the action of P. Because glycodelin-A     has immunosuppressive activity, it may facilitate the process of implantation and the     maintenance of pregnancy.      It is already know that ulipristal acetate (UPA) decrease serum P levels. The hypothesis of     this study is that UPA is been able to modify P serum levels and glycodelin-A endometrial     expression pattern on FSH/GnRH Antagonist cycles for FIV.   "
144590|NCT01391832|"     The objective will be to determine if adding repetitive transcranial magnetic stimulation     prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal     symptoms in individuals with combat related post traumatic stress disorder and improves     clinical outcome.      The investigators have assembled a multimodal human performance laboratory including 64     channel EEG and repetitive transcranial magnetic stimulation system. These resources combined     with the neuroimaging capabilities of the Advanced Imaging Research Center (AIRC) at UT     Southwestern and skilled Cognitive Processing Therapy (CPT) practitioners will be used in     this study.      The study involves approximately 19 visits. Treatment is once a week for 12 weeks followed by     a 1 month, 3 month and 6 month follow-up appointments.   "
144591|NCT01391819|"     The aim of this study is to establish an active surveillance in order to generate dengue     disease burden estimates including incidence rates, prevalence data, clinical presentation     and cost of illness in Forteleza (Brazil).   "
144592|NCT01391806|"     The purpose of this prospective observational study is to evaluate the impact of preoperative     breast MRI in patients with breast cancer selected for breast- conserving surgery. MRI is a     more sensitive radiological modality than mammography and ultrasonography. Patients with     small breast cancers are, based on conventional modalities, selected for breast-conserving     surgery. If preoperative breast MRI reveal additional lesions in the breasts, and malignancy     is confirmed histopathologically, this finding leads to a change of surgical method to     mastectomy.   "
144593|NCT01391793|"     In this study the investigators will determine whether corticosteroids given at the time of     urinary tract infection help prevent permanent damage to the kidneys.   "
144594|NCT01391780|"     Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence     (SUI) and urgency urinary incontinence (UUI).      Methods: 51 women were prospectively divided into two groups, according to the symptoms as     SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of     micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for     which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries     were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min     Pad Test. Subjective [urine stream interruption test (UST), visual survey of perineal     contraction and transvaginal digital palpation] and objective (vaginal manometry) evaluations     of PFM were performed in all patients.   "
144595|NCT01391767|"     This study histologically evaluates sites grafted with NuOss XC using ridge preservation     techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone     mineral with self-expanding collagen) will be compared to sites grafted with NuOss     particulate (bovine bone mineral).   "
144597|NCT01391741|"     People with disease (PD) tend to walk with short steps, decreased velocity, and increased     stride time variability. Short steps and increased variability are related to greater fall     risk. In addition, concurrent performance of a cognitive task (dual-task (DT)) has marked     effects on gait in people with PD which is considered to reflect an impaired automaticity of     gait.      Objective: To investigate short and long term effects of high-volume walking with visual     spatial cues (VSC) on gait variables, automaticity, and functional mobility, in people with     Parkinson´s Disease (PD), compared with walking without VSC.   "
144612|NCT01391546|"     PRIMARY OBJECTIVES      Two co-primary objectives are:        -  To demonstrate that ZOSTAVAX administered by intramuscular route (IM) is non-inferior to          ZOSTAVAX administered by subcutaneous route (SC)        -  To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of          varicella zoster virus (VZV) antibody titres from pre to 4-week post-vaccination      SECONDARY OBJECTIVES      Immunogenicity objectives        -  To evaluate the immunogenicity as measured by VZV antibody titres at 4 weeks following          ZOSTAVAX administered by IM or SC route        -  To evaluate the immune response as measured by a second assay, the VZV Interferon gamma          Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or          SC route      Safety objective      - To describe the safety profile of ZOSTAVAX administered by IM or SC route   "
144598|NCT01391728|"     The purpose of the project is to formulate, implement and evaluate a new type of     activity-orientated, evidence-based prevention programme to prevent fall injuries among     elderly people. The question examined by the study is whether the intervention programme can:        -  significantly reduce accidents and incidents involving falling among the participants,        -  influence variables such as satisfaction with life, confidence in one's own ability and          a feeling of involvement,        -  be shown to be cost effective in terms of the use of resources. The intervention          programme - Active lifestyle all your life - is being developed in and for primary care          for the cost effective prevention of fall injuries among elderly people using a method          that results in continued active life. The aim is to ensure that the elderly person is          able to continue living an active life with commitment and involvement, which can in          itself prevent fall injuries. This presupposes a knowledge of how to avoid fall injuries          and the measures and aids that are available to prevent such injuries. The programme          will also provide the participants with a social community in self-supporting groups          which, by their own efforts but also with social support, are able to continue some of          the activities provided through primary care.   "
144599|NCT01391715|"     To the best of our knowledge, there has been no randomized controlled trial to compare double     dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize     that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.   "
144600|NCT01391702|"     When a woman requires a cesarean section after labour, anesthesia is usually provided by a     pre-existing epidural. Occasionally, the epidural does not work. The anesthesiologist then     may give a spinal anesthetic. The spinal space is identified by seeing cerebrospinal fluid     (CSF) in the spinal needle. Rarely a spinal fails after a failed epidural as the fluid seen     is epidural space fluid, not CSF. This study plans to use a bedside glucose monitor to     measure glucose (sugar) in epidural fluid (compared to CSF) allowing the anesthesiologist to     know the spinal needle is in the correct space.      The investigators hypothesize that a bedside glucose measurement device can accurately     quantitate the level of glucose within epidural space aspirate, and therefore could aid     differentiation between CSF and epidural fluid.   "
144601|NCT01391689|"     This phase II/III trial studies how well diindolylmethane (DIM) works and compares it to     placebo in treating patients with breast cancer. DIM may slow the growth of tumor cells and     be an effective treatment for breast cancer.   "
144602|NCT01391676|"     The aim of this study is imaging of trabeculectomy blebs regarding structure and function     with the spectral domain optical coherence tomography.   "
144603|NCT01391663|"     The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of     alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in     healthy Korean subjects.   "
144604|NCT01391650|"     The purpose of this prospective study is to evaluate the influence of both bundles on the     knee stability - anterior-posterior translation, internal and external rotations after the     double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after     single-bundle and double-bundle reconstruction using a computer navigation system.   "
144605|NCT01391637|"     The purpose of this study is to determine the long term safety and preliminary effect of     HuCNS-SC cells transplanted in subjects with Connatal Pelizaeus-Merzbacher Disease (PMD).   "
144606|NCT01391624|"     The purpose of this study is to determine whether essential polyunsaturated acids (omega 3)     are capable of reducing chocolate craving symptoms in healthy patients.      Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize     neuronal functioning in many conditions, including chocolate craving.   "
144607|NCT01391611|"     This study is being done to gather information about the safety (any harmful effects) and     effectiveness (usefulness) of Pazopanib in the treatment of Gastrointestinal Stroma Tumors     (GIST) that cannot be treated by surgery or has spread to other organs. The Food and Drug     Administration (FDA) have approved Pazopanib for the treatment of advanced kidney cancer but     it is not approved for the treatment of GIST. The investigators hope to learn about the     safety and usefulness (effectiveness) of Pazopanib for patients with GIST.      Primary Objective:      Non-progression rate based on RECIST criteria (CR+PR+SD)      Secondary Objectives:        -  Response per Choi criteria        -  6 month progression-free survival        -  Safety and tolerability   "
144608|NCT01391598|"     The study's primary objective is to evaluate the effect of intravenous lidocaine on pain and     plasma interleukin-1 (IL-1), interleukin-6 (IL-6) and substance P in patients with     fibromyalgia.      As secondary objectives: evaluate the clinical manifestations, and plasma concentration of     lidocaine.   "
144609|NCT01391585|"     The investigators are testing whether patients with diabetes can communicate with our health     care system through text messaging. The investigators will look at how often they respond to     prompts for blood pressures, blood sugars, and step counts. The investigators will also see     if they come in for lab tests when prompted by text message. Also, for patients overdue for     medication refills, the investigators will ask them why they have not yet called for the     refill.   "
144610|NCT01391572|"     A randomized phase II trial to estimate the optimal radiation volume of postsurgical     radiation for patients with locoregionally advanced thoracic esophageal squamous cell     carcinoma (T3-4, any N, M0).   "
144619|NCT01391455|"     There are in excess of 1 million operations performed annually to repair inguinal hernias,     mostly in the male population. Unfortunately, some patients continue to suffer both groin or     testicular pain for varying lengths of time postoperatively. This can lead to a severe     degradation of the patient's lifestyle, work habits and sexual function. The origin of the     pain is felt to be secondary to the inflammatory reaction caused by the mesh. This also     involves the spermatic cord and its structures, leading to orchidinia and possibly     azospermia.   "
144659|NCT01390922|"     The objective of this post-marketing surveillance study is to collect safety, efficacy and     usage data on botulinum injection in subjects with upper or lower limb spasticity on the     long-term use in clinical practice and to identify the factors affecting the safety or     efficacy.   "
144882|NCT01388010|"     The purpose of this study is to evaluate the effect of a commercially available fermented     dairy product containing probiotics (4 weeks, twice a day) on the improvement of     gastrointestinal well being and digestive symptoms in adult women reporting minor digestive     troubles among the general population.   "
144613|NCT01391533|"     Primary Objectives:      To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of     SAR125844 when administered as single agent at the MTD.      To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene     amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer     [NSCLC] patients) and in patients with Phospho-MET positive tumors without MET-gene     amplification.      Secondary Objectives:      To characterize the global safety profile including cumulative toxicities. To evaluate the     pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s).      To assess preliminary antitumor activity in patients with measurable/evaluable disease,     according to RECIST 1.1 criteria.      To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification     status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study,     in the escalation part only.      To evaluate other pharmacodynamic biomarkers and help selection of patients who could benefit     from SAR125844.      To explore MET-gene amplification status in circulating DNA.   "
144614|NCT01391520|"     This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron     chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney     Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are     undergoing diagnostic or interventional coronary angiography will be randomized to either     placebo or CRMD001 and followed for 90 days. Subjects will receive 8 days of randomized     therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be     the difference in a composite of specified renal and cardiovascular clinical events occurring     through Day 90.   "
144615|NCT01391507|"     The purpose of this study is to investigate the effect of COR-1 in combination with standard     therapy in patients with heart failure. The safety and tolerability of COR-1 will also be     assessed.   "
144616|NCT01391494|"     Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth     disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family     Picornaviridae.      Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in     the Asia-Pacific region. Notably, there is evidence that the most severe cases from these     epidemic outbreaks are associated with neurological disorders with CNS involvement caused by     EV71 infection. Because of these EV71 infection-related public health issues, the research     and development of EV71 vaccine candidates have been heavily promoted.      Recently, several EV71 vaccine candidates have been evaluated in animals but no final results     of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA     vaccine, epitope peptide vaccine, virus-like particles (VLPs).      Basing on the previous studies of elicited protection in mice and rhesus monkeys, a     formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA     in China, Dec. 2010. The phase I clinical trial has been carried out, during four months, in     Guangxi Province, China. The purpose of this study is to evaluate the safety, tolerability     and immunogenicity of the formalin-inactivated EV71 vaccine in Chinese adults (from 18 to 49     years old), children (from 3 to 11 years old) and infants (from 6 to 35 months old).   "
144617|NCT01391481|"     PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and     biological properties, including high solubility of gas, swiftness of carrying and release,     low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics     in the body. On the basis of the strong animal data suggesting the efficacy of PFC vapor     inhalation in models of lung injury, we performed a randomized clinical trial comparing PFC     vapor inhalation with conventional mechanical ventilation（CMV）in patients with Acute Lung     Injury/Acute Respiratory Distress Syndrome（ALI/ARDS）. The investigators will apply the     Invasive Mechanical Ventilation (IMV) to the vaporized perfluorocarbon inhalation,     objectively evaluate its curative effect on the acute respiratory distress syndrome, and     meanwhile assess the safety of PFC.   "
144618|NCT01391468|"     This is a randomized double blinded placebo control studies are performed in Chronic Kidney     Disease (CKD) patients. After informed consent, intervention group receives probiotics     containing 109 CFU B. bifidum, B.catenulatum, B. longum, and L.plantarm), while placebo group     receives corn starch. In the first year the investigators examine the 60 peritoneal dialysis     (PD) patients, in the second year the investigators do the 60 hemodialysis (HD) patients, and     in the third year the investigators do the 60 stage 3 and 4 CKD patients. Primary endpoint is     cardiovascular event, gastrointestinal symptoms, peritonitis in PD patients, and progression     of stage 3 and 4 CKD. Values are compared between the groups by unpaired t test. X2 testis     used to compare proportions between the groups. Relative risk and the number needed to treat,     both with 95% CI, are used to describe the treatment effect of probiotics. A p value less     than 0•05 is regarded as statistically significant.   "
144629|NCT01391312|"     This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in     glabellar rhytides (frown lines) using a new treatment satisfaction measure.   "
144620|NCT01391442|"     The Stanislas Cohort is a monocentric familial longitudinal cohort comprised of 1006 families     (4295 subjects) from the Nancy region recruited in 1993-1995 at the Centre for Preventive     Medicine (Centre de Médecine Préventive, CMP), Vandoeuvre lès Nancy for a 5-year periodic     health examination, under the auspices of the Caisse Nationale d'Assurance Maladie (CNAM).      This cohort was established with the primary objective of investigating gene-gene and     gene-environment interactions in the field of cardiovascular diseases, based on the study of     inter-individual variability and familial segregation analysis of biological and     morphological intermediate phenotypes of cardiovascular risk. The longitudinal nature of this     study should enable to take into account the evolution of intermediate phenotypes related to     genetic factors throughout the follow-up period. The families, consisting of two parents and     at least two biological children, were deemed healthy, free of declared acute and/or chronic     illness, in order to assess the effect of genetics on the variability of intermediate     phenotypes studied under physiological conditions (without the influence, in the absence) of     pathology.      The Stanislas Cohort is, both nationally and internationally, the only longitudinal familial     cohort of supposedly healthy subjects on such a large scale.      Brief summary of ancillary study Cardiac Functional Indices Comparison Between MRI and     Echocardiography : the ESCIF study is an ancillary study of the Stanislas cohort aiming at     comparing in a cohort of supposedly healthy subjects different cardiac functional indices     between two different modalities : Echocardiography and MRI. Indeed, new cardiac functional     indices have been recently developed in the scope of echocardiography and would be very     useful in MRI. In echography they are computed either from tissue Doppler imaging or from a     specific image analysis called speckle tracking. These two techniques are accessible in MRI     with the Generalized Reconstruction by Inversion of Coupled Systems (GRICS) technology which     provides a motion model from which strains and strain rates may be derived and which allow     longer acquisition without the constraint of breath holding (mandatory to reach high temporal     resolution).   "
144621|NCT01391429|"     Subject preferences for care at the end-of-life show wide variability. In the setting of     advanced disease, some subjects prefer all life-sustaining care while others forgo such     procedures. The wide variability in preferences may be due to subjects' misconception of the     disease condition when using solely verbal descriptions. The failure to participate in     effective goals-of-care discussions may lead to overuse of medical interventions and     life-sustaining measures that are inconsistent with patients' and families' wishes. Using     video images -- in addition to words -- to convey goals-of-care options at end-of-life, adds     a sense of verisimilitude to the condition described and may better inform subjects when     making their preferences.      Specific Aim: To assess the effect of a video decision support tool on preferences for     end-of-life care in patients and surrogate decision makers consulted on by an inpatient     palliative care service. The investigators hypothesize that those subjects who view video     images as a supplement to a standard palliative care consult will be more likely to opt for     comfort oriented care.      In this study, patient subjects and/or their healthcare proxies who are consulted on by an     inpatient palliative care team will be surveyed regarding their preferences for end-of-life     care following either a standard palliative care consult or one which utilizes a short video     to complement verbal descriptions. The primary analysis will involve the proportion of     patient subjects/proxies in each group that prefer comfort oriented care and that die in     accordance with their stated preferences. The investigators will also study the effect of the     video on patient subjects' and/or proxies' uncertainty with regard to treatment preferences     and overall satisfaction with the palliative care consult.   "
144622|NCT01391416|"     It is well recognized that patients with chronic kidney disease (CKD) have an increased risk     for cardiovascular disease (CVD) and hyperhomocysteinemia appears to be a predictor of future     CVD events. Hyperhomocysteinemia has been reported to bo of high prevalence in patients with     CKD. The investigators aim to study the prevalence of hyperhomocysteinemia in Thai CKD     patients by using Thai Screening and Early Evaluation of Kidney Disease (SEEK) study database     and their relationship to CVD.   "
144623|NCT01391403|"     This study will determine the effectiveness of artemisinin plus risperidone in improving     symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study     addresses the Toxoplasma infection hypothesis of schizophrenia.   "
144624|NCT01391390|"     This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on     therapy to antipsychotics will be performed to examine the effects of melatonin on tardive     dyskinesia symptoms and cognitive deficits in 120 patients with established tardive     dyskinesia (TD). This study addresses a free radical hypothesis of TD.   "
144625|NCT01391377|"     Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque     formation in various arteries, causing narrowing of the artery and a limitation in blood     flow. Depending on which artery the plaque is in, different clinical conditions occur. In     adults common areas include in the heart arteries, in the neck arteries and in the aorta and     lower leg arteries. When it affects the lower limbs it is known as peripheral arterial     disease - PAD.      The main symptom of PAD is called claudication and is described as pain or discomfort in     the legs when walking. The aim of PAD treatment is to improve walking distance and quality of     life in those with intermittent claudication, and to decrease long term complications     including illness and death.      An important controlling factor of these cholesterol plaques is a type of cholesterol called     HDL (High density lipoprotein).      This study aims to look at the effect that raising HDL for a prolonged period has on blood     markers of inflammation and on the cholesterol plaque composition in patients with PAD. This     investigation will also have relevance to the effects of HDL elevation on plaque composition     and inflammation in other areas of the body including the heart, neck and brain arteries.      Twenty (20) PAD patients with will be recruited into the study. The investigators anticipate     recruitment of all 20 patients within 12 months. The 20 PAD patients all must have     significant leg pains when walking, and after review by a doctor, be determined to have     narrowings in the leg artery that they will plan to operate on. Patients will be randomized     to either niacin (Tredaptive, 1g/day) or matching placebo for 8 weeks (prior to operation)     After the 8 week period they will then go on to receive the normal interventional treatment     as planned. Blood samples will be taken at enrollment and at the 8 week mark prior to     surgery. The plaque that is removed at the time of operation will also be sent to the lab for     analysis.      The investigators hope to show with this study that by raising the levels of HDL with     extended release niacin, there are positive effects on the amount of cholesterol in the     plaque, and on the markers in the blood of inflammation and thrombosis.      The hypothesis is that elevation of HDL with Niacin will have anti-atherosclerotic actions     including: Lower plaque lipid content, Reduced plaque macrophage infiltration, Reduced     monocyte activation, Reduced neutrophil adhesion, Inhibition of inflammation and Inhibition     of thrombotic markers.   "
144626|NCT01391351|"     In order to search for predictors of response to chemotherapy in patients with ovarian     carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will     define the comparative profiles of miRNA expression of serum polymorphisms and determine     differential in 2 patient populations (with or without recurrence 6 months after completion     of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification     of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the     metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be     studied during the first course in response to chemotherapy. Indeed, the miRNA profile of     serum may be different at baseline among the 2 types of populations (or non-recurrence at 6     months).   "
144627|NCT01391338|"     In this study several doses of ASP3652, given orally for 12 weeks, will be compared with     placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic     Pain Syndrome.   "
144634|NCT01391247|"     Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Up     until today, very little is known about the metabolic alterations in the retina of glaucoma     patients, since only techniques for surrogate measurements of metabolism (like blood flow     velocities and vessel diameter) were available. Oximetry has provided us with an important     tool to study metabolism in glaucoma, and to correlate these findings with the available     blood flow evaluation techniques. Preliminary results by the group of Prof Stefánsson (2011)     with the dual wavelength oximeter pointed out that deeper glaucomatous visual field defects     are associated with decreased arteriovenous differences in retinal oxygen saturation. These     data suggest that a change in oxygen metabolism occurs in glaucomatous retina. This reduced     oxygen metabolism may be related to tissue atrophy. However, this explanation is still     hypothetical, since the relation between these oximetry results and structural changes in the     optic nerve have not been studied yet.        1. What are the oximetry values in a normal population of within the same age group as the          glaucoma population? To answer this question, a normative database of the investigators          retinal oximetry device needs to be constructed for healthy controls.        2. Do glaucoma patients have different retinal oximetry values than these normal patients?          Are there any differences in retinal oxygenation between these glaucoma groups? To          answer these questions, oximetry measurements will be performed in patients with normal          tension glaucoma (NTG) and primary open angle glaucoma (POAG).        3. Is there an association between structural optic disc and retinal nerve fibre layer          changes, using Heidelberg Retinal Tomography (HRT), with alterations in retinal vascular          oxygen saturation in NTG and POAG patients?        4. Are blood flow measurements, using colour Doppler imaging (CDI), correlated with          alteration in retinal vascular oxygen in NTG and POAG patients?   "
144898|NCT01387802|"     The current study will assess the real - life effectiveness of adalimumab in the management     of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of     extra-articular manifestations.   "
144899|NCT01387789|"     An observational, non-interventional study on social, economic and quality-of-life outcomes     of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.   "
144635|NCT01391234|"     The purpose of this research study is to evaluate the safety and effectiveness of an     experimental workflow that may result in a faster way to plan and deliver radiation for the     treatment of pain caused by metastatic bone tumors (tumors that originally came from another     organ and have spread to bones causing pain) or multiple myeloma (a type of cancer that     begins in white blood cells that produce antibodies).      The current standard of care radiation treatment planning and delivery takes 2 to 3 weeks     from start to finish. The investigators have developed an experimental workflow: a radiation     treatment planning and delivery workflow called STAT RT (STAT means right away, and RT     means radiation therapy). This experimental workflow may shorten the time it takes to plan     and treat painful bone metastases to 1 week or less. All steps in this process will be     performed within the current standard of care but in a shorter time frame to allow treatment     to start sooner.      The investigators will evaluate effectiveness by requesting patients to complete pain and     quality of life questionnaires before and after treatment. The investigators will also be     collecting additional information from their treatments that will help us make future     workflows even more efficient.   "
144636|NCT01391221|"     Major depression is accompanied by cognitive changes as well as alterations in multiple     physical functions. The inflammatory system is altered generally toward a pro-inflammatory     state. Antidepressants are associated with a decrease in this proinflammatory state. This     study aims to generate pilot data concerning a possible link between cognition, inflammation     and response to treatment. The cognitive function of subjects with major depression will be     tested before and after treatment with duloxetine. Inflammatory markers will be measured at     both time points.   "
144637|NCT01391208|"     You are invited to participate in a research study to develop new ways to look for abnormal     areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are very     good, but if the area doesn't look different to the naked eye, then the endoscope can't     improve on that. The investigators are looking at using special fluorescent stains in     addition to special endoscopes designed to see abnormal areas that are not obvious to the     naked eye. Currently specialized microscopes and fluorescent stains are used in clinical     laboratories but it takes several days of processing to get results. It may be very helpful     to look for areas to sample for abnormal tissue during the endoscopy procedure.      You are being asked to let us use fluorescent peptides with a special endoscope that allow     us to see of your esophagus with both fluorescent and white light during your upper GI     endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids     (the building blocks that make up proteins) linked together. Our peptide is a chain of 7     amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor).      The investigators have prepared special fluorescent peptides, that will glow when a     special light is used that should help us separate normal tissue from abnormal tissue. In     this study, the investigators will apply the special fluorescent peptides by a spray catheter     to your esophagus to help us target you biopsies. Both routine and targeted biopsies will be     taken as your endoscopist feels is indicated.      This is a phase 1 study. This means that this is the first time the investigators have used     this kind of fluorescent peptide in people. The Food and Drug Administration (FDA) has not     approved this agent, but is allowing us to test it in this study. The main goal of this study     is to see if there are any side effects from using the peptide. Our second goal is to see if     the peptide glows well and if the investigators can take pictures of the areas that do     glow.      This is the first test of this agent, so it won't be used to change how your biopsies are     taken nor how your endoscopy is done.   "
144638|NCT01391195|"     The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of     young women submitted to chronic endurance training program associated to low level laser     therapy when compared to chronic aerobic training alone.   "
144639|NCT01391182|"     You are being asked to take part in this research study because you are scheduled to have     total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the     effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for     patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug     Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA     to prevent bleeding during and after surgery; use of this drug as a means of preventing     bleeding is not currently approved by the FDA.   "
144640|NCT01391169|"     This is a control matched prospective study evaluating the use of seromuscular flap for high     risk anastomoses.   "
144641|NCT01391156|"     The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil     with 0.1% Finasteride lotion for 6 months in male pattern hair loss.   "
144642|NCT01391143|"     The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV)     infusion to patients with refractory cancer. The study will also evaluate how long MGA271     stays in the blood and how long it takes for it to leave the body, what is the highest dose     that can safely be given, and whether it may have an effect on tumors.   "
144643|NCT01391130|"     To compare the progression free survival of LY2510924 plus sunitinib therapy versus sunitinib     in the first-line setting for patients with metastatic clear-cell renal cell carcinoma.   "
144654|NCT01390987|"     Prompt access to care and treatment adherence are the hearth of tuberculosis control.      This is a multicentre observational prospective study aimed at studying the factors     associated with delayed access to care and low adherence to anti-tuberculosis treatment.     Hetero- and self-administered questionnaires will be used at enrollment to assess clinical     presentation and time and modalities of the diagnosis. Treatment adherence will be assessed     during the follow-up with self administered questionnaires.   "
144655|NCT01390974|"     To demonstrate that a strategy of fast genetic testing performed in outpatient clinic allows     to select adequately one of the 2 antiplatelet treatments approved in the same indication     (ACS with PCI - prasugrel 10mg MD or clopidogrel 75mg MD). Patients will reach similar levels     of platelet inhibition with the 2 different thienopyridines suggesting optimal risk/benefit     ratio in most patients with individualized therapy.   "
144644|NCT01391117|"     The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected     participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the     body, how it is distributed within the body and removed from the body over time) and     antiviral activity of repeated doses of TMC649128 given as monotherapy and given in     combination with pegylated interferon + ribavirin. We assess the     pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD)     relationship for antiviral activity, active metabolite and safety of TMC649128 and its     metabolites. We determine the short term safety and tolerability of the co-administration of     TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in     treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated     interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for 14     days in treatment-naive genotype 1 HCV-infected participants. We also assess in a preliminary     way the short term antiviral effect of the combination of TMC649128 with pegylated interferon     + ribavirin during a 14-day dosing period in treatment-naive genotype 1 HCV-infected     participants.   "
144645|NCT01391104|"     Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in     pulmonary vascular resistance leading to shortness of breath and exercise intolerance.     Exercise capacity has been used as the primary endpoint in most recent randomized controlled     trials evaluating PAH-specific therapies as it correlates with functional class and survival     in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there     is commonly some discrepancy between significant clinical improvement and minor changes     (generally <10% from baseline) in 6WMT following therapy. Because important clinical     decisions are based on patients' functional capacity, a reproducible and sensitive exercise     test is needed in PAH. The aim of this study was to compare the reproducibility and the     responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance     test (CET) following pharmacological therapy in this disease.   "
144646|NCT01391091|"     The purpose of this prospective study is to evaluate the effect of catheter ablation on     incidence, prevalence and disease-severity of migraine in AF patients undergoing ablation,     with or without a history of migraine.   "
144647|NCT01391078|"     This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF)     continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma     patients. There are two control measurements: The GAT/Perkins profile in the same eye in the     second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each     eye serves as test eye and also as control for the second test eye.   "
144648|NCT01391065|"     The proposed two stage study will evaluate patterns of local recurrence after EBRT and     brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in     patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The     first stage of the study will focus on developing MR guided interstitial brachytherapy and     validating the concept of high risk gross tumor volume (on the basis of functional imaging     features).      The second stage thereafter will focus on developing biologically modulated interstitial     brachytherapy.      In the proposed two staged study the investigators intend to prospectively evaluate and     validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy.     The demonstration of technical feasibility and clinical safety of biologically modulated     image guided radiotherapy in this pilot study for may pave the way for improving local     control in patients with postoperative recurrences.   "
144649|NCT01391052|"     Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side     effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy     menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of     post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively     slough the endometrium prior to insertion of the LNG IUS.   "
144650|NCT01391039|"     This is a pilot study designed to investigate new techniques to guide the appropriate     diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and     stiffness of the lesion may be prognostic factors that can guide the need for more or less     extensive therapy or perhaps only imaging follow-up may be needed.   "
144651|NCT01391026|"     Patients who have advanced or multiple chronic illnesses present management difficulties for     primary care providers. Acute medical issues and limited time for patient evaluation can     complicate complete assessment of physical symptoms that directly impact a patient's quality     of life. The Cook County Health and Hospitals System (CCHHS) established an Advanced Illness     Management Clinic to provide care for complex patients. Patient entry into the Advanced     Illness Management Clinic is by referral only, a passive process. After discharge, general     medicine clinic patients who do not have a medical provider are given an appointment in the     clinic. Since the hospital is the source of many patients, this guarantees that these     patients will have at least one illness advanced enough to require hospitalization, and most     will have additional chronic illnesses. An outpatient palliative care clinic located in a     specialty clinic setting was initiated in 2004. The goal of the clinic was to extend the     benefits realized by hospital patients, for whom palliative care consultation has been     available for many years, to patients cared for in the outpatient setting. The benefits     provided include physical symptom management, spiritual counseling, and support for social     issues. Until recently, this outpatient palliative care model has mainly served patients with     malignancy. With the addition of the Advanced Illness Management Clinic, palliative care     clinicians now can provide care to patients with other chronic and serious illness in the     primary care setting.      Hypothesis: Complex patients will have improved quality of life and a reduced symptom burden     if seen by a multidisciplinary clinic post-hospitalization, compared to usual care in a     general medicine clinic.   "
144652|NCT01391013|"     The purpose of this study is to compare change of brachial artery flow mediated     vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use     of a single medication) versus a triple combination therapy containing 2 nucleoside reverse     transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected     participants.   "
144653|NCT01391000|"     The purpose of this study is to evaluate the most effective method between Transcutaneous     Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy     carbon dioxide therapy for pain control in the post-surgical rehabilitation of patients     treated with reconstruction of the rotator cuff.   "
144657|NCT01390948|"     This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety,     tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy     with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant     and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically     confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or     infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be     randomly assigned to one of two treatment arms.      Upon approval by the Health Authorities/Ethics Committees in the participating countries, an     additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with     progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO     Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab     and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.   "
144658|NCT01390935|"     The purpose of this study is to survey the guideline compliance of the cardiologists in the     treatment of systolic heart failure in Korea   "
144660|NCT01390909|"     Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy;     however, complete seizure control remains elusive for many patients. Uncontrolled or     refractory epilepsy is associated with a higher risk of mortality, physical injuries, and     depression or anxiety compared with patients with controlled epilepsy. Higher resource     utilization for patients with poor control is likely to be associated with higher economic     costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists,     recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one     seizure per month and 2.) a history of drug failures.      The objective of this study is to identify patients with uncontrolled epilepsy in both a     Medicaid database and a private health plan database, to describe patient characteristics and     AED treatment patterns between cohorts of patients with uncontrolled versus well-controlled     epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled     epilepsy.      For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases     from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second     quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter     1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and     medical and pharmacy claims in an private health plan database.      The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient     records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy     (at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1     epilepsy-related inpatient or emergency department (ED) visit within 365 days),     well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits), and     intermediate epilepsy (not classified as uncontrolled or well-controlled).   "
144661|NCT01390896|"     The purpose of this study is to collect and assess information on safety and efficacy of     fondaparinux in patients undergoing general surgery of the lower limb at high risk of     developing venous thromboembolism.   "
144662|NCT01390883|"     The purpose of this study is to collect and assess information on safety and efficacy of     fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology     departments who are at high risk of venous thromboembolism.   "
144663|NCT01390870|"     Patient-based surveys will be conducted to evaluate the drivers of medication adherence in     patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB)     therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be     evaluated. The researchers believe that the majority of participants will report that they     are compliant with therapy. The data source is a cross-sectional patient survey administered     at one time point.   "
144664|NCT01390857|"     The purpose of this post-marketing surveillance study is to collect and assess information on     safety and efficacy of valaciclovir in pediatric patients with chickenpox   "
144665|NCT01390844|"     This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron     (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared     to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C     (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia     Pacific population. The primary hypothesis is that the proportion of participants achieving     sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to     that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.   "
144666|NCT01390831|"     The purpose of this study is to determine whether renal denervation is safe and effective in     the treatment of Chinese patients with uncontrolled hypertension.   "
144667|NCT01390818|"     This research trial is testing a combination of two experimental drugs, MSC1936369B     (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and     SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR)     inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary     purpose of the study is to determine the maximum tolerated dose of the drug combination.   "
144668|NCT01390805|"     The purpose of this study is to collect and assess information on proper use of valaciclovir     regarding safety and efficacy of long-term use in suppressive therapy for subjects with     recurrent genital herpes.   "
144669|NCT01390792|"     The purpose of this post-marketing surveillance study is to collect information on efficacy     and safety for prophylactic administration of zanamivir in clinical practice in family or     persons living with patients with influenza virus infection.   "
144670|NCT01390779|"     The objectives of this study are to assess the safety and effectiveness of the SENSIMED     Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular     pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous     TF recording.      TF efficacy will be evaluated by demonstrating TF ability to detect:        1. The known phenomenon of increase in IOP when moving from waking state to going to bed,          as reflected in pneumotonometer measurements        2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).      A screening visit and one 24-hour IOP fluctuation recording session are planned for each     patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An     ophthalmological examination of the eyes will be done at screening and prior to and following     the device recording.   "
144671|NCT01390766|"     This post-marketing surveillance (PMS) study is designed to investigate the efficacy and     safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.   "
145089|NCT01385267|"     Objectives:      To evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and     body weight. If we find discordance in fetal lung maturity in twin gestations this will     change current practice of sampling only one amniotic sac for evaluation of fetal lung     maturity.   "
144672|NCT01390753|"     Acute respiratory infections are the leading cause of hospitalization in premature infants     worldwide. Severity rates are particularly high in developing countries. Numerous viruses can     cause severe disease, but the most frequent agent of hospitalization is respiratory syncytial     virus (RSV). In a recent study in Argentina, 58% of RSV infected VLBW infants required     hospitalization and 19% required mechanical ventilation. One every twenty infected infants     died. Unlike industrialized nations, VLBW infants in developing countries often lack access     to prophylaxis against RSV with a commercially available monoclonal antibody (palivizumab).     No vaccine or preventive intervention is available against any respiratory virus for infants     younger than 6 months of age in developing countries and the public sector of most     middle-income countries.      The protective role of breastfeeding against respiratory infections in developing countries     is well established. But while similar beneficial effects have been described for premature     infants, the dropout rate for breastfeeding in families exposed to the uncertainties and     stress of the early months of life in the neonatal intensive care unit is very high. The     World Health Organization recommends the use of Human Milk Donor Banks to feed infants that     cannot be breastfed by their own mothers. These banks are established with the purpose of     collecting, screening, processing (including pasteurizing), testing and distributing donated     human milk. The potential benefit of donated milk against acute disease elicited by RSV is     unknown. The investigators propose to study the role of supplemental donated human milk in     the prevention of hospitalizations caused by RSV in non-breastfeeding premature infants.     Since the investigators expect the benefits of breast milk to extend beyond protection     against RSV, the effect of human milk against respiratory infections elicited by other     viruses will also be evaluated.   "
144912|NCT01387620|"     This prospective study was performed to compare two ophthalmic viscosurgical devices,     DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose     2% in terms of their overall clinical performance during phacoemulsification.   "
144674|NCT01390727|"     Hypertension is a chronic disease that affects about 23% of the brazilian population. The     treatment of hypertension by pharmacological intervention is efficacious, but has side     effects and significant costs. Techniques that reduce the respiratory rate are shown as a     effective non-pharmacological treatment in controlling blood pressure. Evidence has shown     that a slow and deep breathing rate, around 10 breaths per minute or less, significantly     reduces blood pressure. However, the physiological mechanisms involved in blood pressure     decrease due to decreased respiratory rate are not yet known. Therefore the goals of this     study will evaluate the chronic effect of breathing exercise guided on office and 24 hours     blood pressure and analyse the chronic effect of breathing exercise guided over the autonomic     function in hypertensive patients in stages 1 and 2.   "
144675|NCT01390714|"     The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of     E3710 following oral administration to Healthy Male Japanese Subjects   "
144676|NCT01390701|"     The purpose of this study is to compare the blood pressure reducing property of     transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.   "
144677|NCT01390688|"     Individuals with type 2 diabetes have an increased risk of developing cognitive dysfunction     followed by dementia in late life. Obesity, physical inactivity and systemic low-grade     inflammation are strong risk factors and play a crucial role in this network of diseases.      Brain-derived Neurotrophic factor (BDNF) is produced in brain as well as several tissues     outside brain eg muscle cells. Low BDNF are associated with cognitive dysfuction, obesity and     type 2 diabetes.      The investigators include 200 individuals divided into three groups: 80 individuals with type     2 diabetes, 80 age and BMI-matched controls and 40 individuals with impaired glucose     tolerance.      The project will test the hypothesis, that low systemic BDNF are associated with accumulation     of abdominal fat, cognitive dysfunction and insulin resistence with different effect in men     and women.   "
144678|NCT01390675|"     In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an     emerging procedure for high-risk patients that are assumed to be otherwise inoperable. The     investigators want to evaluate the specific intraoperative anesthesiologic characteristics     cardiac anesthesiologists have to face during these procedures.   "
144679|NCT01390662|"     The purpose of this study is to investigate whether patients with depression should be     offered vitamin D supplements, or it has no significance in relation to treatment outcomes.   "
144680|NCT01390649|"     It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not     known in detail. The primary objective of this study was to investigate the specificity of     antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP)     who have shown signs of clinically relevant hemolysis following treatment with the     intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of     hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish     between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an     independent adjudication by a committee was performed for each patient with signs of     hemolysis determined in the laboratory or in the clinic.      This study was requested as a post-marketing commitment study by the United States Food and     Drug Administration (FDA). By September 2014, no case of clinically significant intravascular     hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant     endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol.     The study was not restarted.   "
144681|NCT01390636|"     The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to     determine the degree of variation in glucose levels of individuals with an eating disorder     and type 1 diabetes and only an eating disorder.   "
144682|NCT01390623|"     Urinary tract community infections are one of very frequent reason consultation and     prescription. Urinary tract represents the second site of bacterial community infection after     the respiratory system. The management of the acute uncomplicated pyelonephritis was simply     codified in the past recommendations of the French Agency for Safety Health Products     (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones     with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.      The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally     provides a simplified treatment for patients, a reduced use of fluoroquinolones and a     probable decrease in correlation with the emergence of fluoroquinolones resistance, and     finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.   "
144684|NCT01390597|"     RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may     help doctors learn more about changes that occur in DNA and identify biomarkers related to     cancer. It may also help doctors find better ways to treat the cancer.      PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with     peripheral T-cell lymphoma or natural killer cell neoplasms.   "
144685|NCT01390584|"     RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate,     vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride,     vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer     cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses     high-energy x rays to kill cancer cells. Giving combination chemotherapy together with     radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such     as PET scans and CT scans, done before, during, and after chemotherapy may help doctors     predict a patient's response to treatment and help plan the best treatment.      PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan     works in treating patients with stage I or stage II Hodgkin lymphoma.   "
144686|NCT01390571|"     RATIONALE: Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed     for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Olaparib may help temozolomide kill more tumor cells by making tumor cells more     sensitive to the drug.      PURPOSE: This phase I trial is studying the side effects and best dose of olaparib and     temozolomide in treating patients with relapsed glioblastoma.   "
144687|NCT01390558|"     This is a research study of persons with Down Syndrome between 2 and 80 years old who are     independently walking. The purpose of this study is to see what effect orthotics have on how     people with Down Syndrome walk.   "
144688|NCT01390545|"     This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm     parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of     veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc)     injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative     veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on     continued stable co-medication with methotrexate (MTX).   "
144689|NCT01390532|"     Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with     advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not     clinically improve with CRT. New LVD markers other than QRS duration are needed.      Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated     SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®,     Ceasaria, Israel) to quantify LVD.   "
144690|NCT01390519|"     This is a Norwegian prospective registration, observational study of patients with advanced     renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI)     ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these     patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.   "
144691|NCT01390506|"     After cardiac arrest and successful resuscitation it can happen that the brain function of a     patient is impaired because the brain was without oxygen for a prolonged period of time.     Several strategies have been studied to improve brain function after cardiac arrest. Cooling     of the patients is routinely used today. The trace element selenium has several biological     functions and is important for defense mechanisms against oxidative stress, which occurs     after cardiac arrest and successful resuscitation. critically ill patients have low selenium     blood levels. Therefore the investigators hypothesize that giving selenium after cardiac     arrest and successful resuscitation might improve brain function.   "
144692|NCT01390493|"     The purpose of this study is to determine whether neurofeedback training can significantly     reduce the symptoms of anorexia nervosa (AN) with focus on changes in personality and     psychological well-being. The primary aims of this study include:        1. To examine whether AN patients are able to control their alpha-activity through          neurofeedback.        2. To examine the effects of neurofeedback on symptomatology and personality variables in          AN patients.        3. To examine the long-term effects of neurofeedback in the treatment of AN.   "
144693|NCT01390480|"     In this placebo controlled study the investigators aim to investigate the effects of vitamin     D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine     and metabolic parameters.   "
144694|NCT01390467|"     Randomized study, double-blind, crossover, controlled versus placebo.   "
144695|NCT01390454|"     Our primary objective is to study the relationship between ultra sound data and the pain     associated with tennis elbow.   "
144696|NCT01390441|"     This is a study of the overall safety, tolerability, and pharmacokinetics (PK) of MK-8808     versus rituximab (MabThera® and Rituxan®) in participants with moderate to severe RA with an     inadequate response or intolerance to methotrexate.   "
144697|NCT01390428|"     This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered     to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria     of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy     participants.   "
144698|NCT01390415|"     This study will evaluate whether losartan protects the kidney in hypertensive Type II     diabetic participants with microalbuminuria.   "
144699|NCT01390402|"     The goal of this clinical research study is to learn if giving a kind of immune cell called     natural killer (NK) cells after chemotherapy will improve the response to a stem cell     transplant in patients with CML. The safety of this treatment will also be studied.   "
144700|NCT01390389|"     The investigators propose to study and compare measures of brain energy metabolism in     geriatric bipolar individuals and healthy older adults. The investigators would also like to     investigate changes in brain energy metabolites associated with CoQ10 administration in older     bipolar individuals. Finally, resting state functional Magnetic Resonance Imaging (fMRI) will     be conducted in order to explore frontal and limbic circuitry in geriatric bipolar disorder.        -  Primary Hypothesis: Baseline beta NTP and NAA will be lower, and PCr and lactate higher          in Geri BPD compared with older healthy controls        -  Secondary Hypothesis: Changes in PCr and beta NTP will be demonstrated in Geri BD group          challenged with CoQ 10.   "
144701|NCT01390376|"     Pharmacotherapy for schizophrenia has limitations such as residual positive and negative     symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia     (particularly clozapine-resistant) is still a difficult clinical issue at present. According     to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have     therapeutic benefit. DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing     agents.      The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant     treatment for clozapine-resistant refractory schizophrenia patients in a randomized,     double-blind, placebo - controlled trial.   "
144702|NCT01390363|"     The purpose of this study is to determine whether contacting the parents of adolescents     overdue for routine vaccines or contacting both the parents AND adolescents overdue to     routine vaccines improves immunization rates as compared to usual care.   "
144724|NCT01390077|"     Nitisinone is a potent inhibitor of the enzyme that catalyzes the formation of homogentisic     acid, and should be an even more logical treatment for alkaptonuria than for tyrosinemia, for     which it has been approved by the FDA.The objective of this research is to explore reported     age related differences in toxicity of nitisinone and its pharmacokinetic underpinnings and     to develop an optimal therapeutic requirement for a targeted population of presymptomatic     patients. The additional effect of mixtures of amino acids excluding tyrosine will be     explored to take advantage of protein synthesis to avoid elevations of tyrosine that would     otherwise limit the optimal dosage of nitisinone. The study is designed to treat patients and     find the optimal dosage of nitisinone to obtain maximal reduction in levels of homogentisic     acid and maintain safe levels of tyrosine.      The long term objective in the target population of pre-symptomatic patients is the     prevention of the characteristic effects on joint cartilage and tendons.   "
144703|NCT01390350|"     This is a multi-center double-blind placebo-controlled study to assess the efficacy and     safety of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that     neutralizes IL-1β, in patients with Schnitzler syndrome. Efficacy is assessed by physician's     global assessment (a combined clinical symptom score) and inflammation markers. Following a     baseline period of 1-4 weeks, patients will be randomized to receive single s.c. injections     of either 150 mg canakinumab or placebo (day 0). Treatment response will be assessed on day     7. Patients will then be eligible to enter the 16-week open-label phase and receive     canakinumab injections (150-300mg, dose depends on clinical response on day 7) upon relapse     of symptoms. Visits for investigator's assessments will be scheduled at 4-weekly intervals     following day 7. Overall a max. of 20 subjects with Schnitzler syndrome will be enrolled.        1. Amendment: After successful completion of the 16-week open-label phase patients will be          eligible to enter a one-year open-label extension of the study. During this part of the          study patients will be scheduled at bi-monthly intervals. Canakinumab dosing will be          performed upon relapse of symptoms comparable to the 16-week open-label phase.        2. Amendment: After successful completion of the 1-year open-label study extension patients          will be eligible to enter another 3-year open-label extension. Patients will be          scheduled at 3-month-intervals and Canakinumab dosing will be performed on an individual          basis with optimized dosing intervals to ensure a constant low disease activity.   "
144704|NCT01390337|"     The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when     combined with induction and consolidation therapy and as maintenance therapy following     induction and consolidation.   "
144705|NCT01390324|"     The purpose of this study is to determine whether a fixed-dose combination of naratriptan +     naproxen is effective compared each monotherapy for the acute treatment of migraine.   "
144706|NCT01390311|"     This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the     standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or     myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC     includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or     DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the     function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while     maintaining the anticancer effects.   "
144707|NCT01390298|"     The purpose of this study is to provide preliminary data for a Program Project Grant to the     National Institutes of Health to examine specific explanations regarding identifying patients     at risk for chronic pain after surgery and identifying mechanisms which may be altered to     decrease this risk.      This study will help investigators better understand chronic pain that develops after     surgery. We are proposing to study different factors related to the surgical experience and     factors in the environment to determine if any play a role in the development of chronic pain     after surgery.   "
144708|NCT01390285|"     Background      Central sensitization has recently been documented in patients with knee osteoarthritis. So     far, the presence of central sensitization has not been considered as a confounding factor in     studies assessing the pain inhibitory effect of TENS on osteoarthritis of the knee.      Purpose      First, to explore the pain inhibitory effect of burst TENS in OAk patients. Second, to     explore the prognostic value of central sensitization on the pain inhibitory effect of TENS     in Oak patients.      Methods      Patients with knee pain due to OAk will be recruited through advertisements in local media.     Temporal summation, before and after a heterotopic noxious conditioning stimulation, will be     measured. In addition, pain on a numeric rating score and WOMAC subscores for pain and     function will be assessed. Patients will be randomly allocated to one of two treatment groups     (TENS, sham TENS). Follow-up measurements will be scheduled after a period of 6 and 12 weeks.      Discussion/ conclusion      TENS influences pain through the electrical stimulation of low-threshold A-beta cutaneous     fibers. The responsiveness of central pain-signaling neurons of OAk patients who are     centrally sensitized may be augmented to the input of these electrical stimuli. This would     encompass an adverse therapy effect of TENS. Therefore it might be interesting to identify a     subgroup of symptomatic OAk patients, ie. non-sensitized patients, who are likely to benefit     from burst TENS.   "
144709|NCT01390272|"     This randomized clinical trial examines whether programs aimed at matching resources to     patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic     blood pressure (top number of blood pressure reading) than simply having maintenance phone     calls in addition to usual care. Answering this question will provide important evidence     concerning the overall goal of sustained long-term implementation of the disease management     programs as part of patient aligned care teams in the Veterans Affairs and other healthcare     systems.   "
144739|NCT01389869|"     Obesity is closely related to metabolic diseases and its prevalence is sharply increasing.     However, there is no safe and effective treatment for obesity so far, the investigators need     a breakthrough idea to curtail the constant threat of obesity. It has been recently     demonstrated that emotional tears of women can modify sexual responses, one of basic     instincts, in men. As appetite and food intake is another basic instinct, chemosignals from     tears and plasma may modify appetite and eating behavior in humans.   "
144740|NCT01389856|"     The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled     nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a     supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its     metabolites.   "
144726|NCT01390051|"     The purpose of the study is to investigate if treatment with an anticoagulant drug increases     birth weight in pregnancies complicated by fetal growth restriction.   "
144727|NCT01390038|"     The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder     System in total shoulder arthroplasty.   "
144728|NCT01390025|"     The purpose of this study is to compare the safety profile in healthy volunteers of a single     intravenous administration of TCN-032 as compared with placebo.   "
144729|NCT01390012|"     The purpose of this study is to assess bioequivalence for dexamethasone administered orally     versus intravenously in patients admitted to hospital for pneumonia.   "
144730|NCT01389999|"     The goal of this study is to carry out a transcultural validation of the Back Belief     Questionnaire in order to assess its appropriateness for French-speaking populations.   "
144710|NCT01390259|"     In this protocol the investigators plan to demonstrate management of glucose using a modular     insulin management system based on continuous glucose monitoring and targeted towards the     avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The     protocol is designed to challenge the insulin management system with meals and mild exercise,     so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic     state. This system is designed to both        -  monitor the meal boluses of the patient and correct it in case of observed/predicted          under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and          subjective knowledge of the meal amount, a precise understanding of the subject's day to          day insulin treatment, continuous glucose monitoring, and past insulin injections;        -  predict and avoid hypoglycemic events, based on continuous glucose reading and past          insulin injection.      The investigators plan to enroll 12 adolescent T1DM patients (expected retention 10/12) and     compare glucose control performances under two treatments: standard vs. the new insulin     management system. The protocol will include a total of 5 admissions per subject (3     out-patients and 2 in-patients): screening, CGM insertion 1, CGM insertion 2, inpatient 1 and     inpatient 2. During the 24h inpatient admissions the patients will be challenged with 30     minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on     the chosen treatment, each subject will be exposed to both studied treatments (repeated     measure design). The order of treatment during the inpatient admissions will be randomized.   "
144711|NCT01390246|"     This is a prospective, double-blind placebo-controlled randomized controlled trial of the     preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for     smoking cessation during pregnancy.   "
144712|NCT01390233|"     This study is designed to assess the effectiveness of a combination method of induction of     labor using a urinary balloon catheter and prostaglandin gel.      The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery     rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed     induction in the United States is rising. This has led to a renewed effort to examine the     effectiveness of the varied methods of induction.      The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel     for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto     Health Richland for a scheduled induction of labor will be offered enrollment in the trial.     Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon     catheter only, prostaglandin gel only and combination urinary balloon catheter and     prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication     storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The     investigator will be given the next sequentially numbered study randomization envelope by the     patient's nurse. The randomization assignment will be unblinded to the patient and her     physicians. If the patient is not in active labor 6 hours after initiation of the     intervention, a standardized protocol of oxytocin will commence. Labor management will be at     the discretion of the physician.   "
144713|NCT01390220|"     The purpose of this study is to examine the safety and effectiveness of USL261 for the     outpatient treatment of seizure clusters.   "
144714|NCT01390207|"     The effect of altering the timing of hCG administration on the ongoing pregnancy rate in     patients stimulated with recombinant-FSH (rec-FSH)/gonadotrophin releasing hormone (GnRH)     antagonists for in vitro fertilisation (IVF).   "
144715|NCT01390194|"     The purpose of this study to assess the image quality of the rapid MRI compared to the     standard MRI.   "
144716|NCT01390181|"     The specific aims of this study are to:        -  Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in          individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements          >40mm.        -  Assess the effect on MMP levels during treatment with losartan, an angiotensin II          receptor blocking agent.        -  In the setting of losartan therapy for one year, evaluate the response of MMP levels in          these patients, and clinical outcomes including effects on aortic growth rate   "
144717|NCT01390168|"     The purpose of this study is to determine whether tailored internet-administered cbt is a     feasible treatment for anxiety disorders in clinical settings.   "
144718|NCT01390155|"     Esophageal electrocardiography (eECG) has important advantages compared to standard ECG     recordings.      Coronary artery disease leading to myocardial ischemia is very common and has potentially     severe consequences for patients. To date, the investigators don't know the influence of     ischemia on the eECG. The goal of the present study is to assess ischemic changes of the eECG     induced by balloon occlusion of coronary arteries in patients undergoing coronary     angiography.   "
144719|NCT01390142|"     RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis     that remote ischemic preconditioning initiated at the time of the admission in the cathlab     reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated     with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a     combined approach remote ischemic preconditioning and local ischemic postconditioning can     further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance     imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.   "
144720|NCT01390129|"     RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote     ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in     aortic valve surgery. Infarct size will be determined by 72 hours area under curve of     troponin-I.   "
144721|NCT01390116|"     The purpose of this study is to determine whether consuming capsules of aged garlic extract     is effective in enhancing function of NK and/or γδ T cell resulting in fewer cold and flu     symptoms.   "
144722|NCT01390103|"     The purpose of this project is to determine the effect of hip injections on hip biomechanics     in patients with hip pain.   "
144723|NCT01390090|"     Subjects will have failed conservative treatment, including, but not limited to oral     medications, physical therapy, manual manipulation, and/or alternative medicine. They will be     evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and     will be scheduled for a piriformis muscle (PM) corticosteroid injection.   "
144745|NCT01389791|"     Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on     muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the     rocuronium-priming.   "
144731|NCT01389986|"     Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer,     paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function     through the cephalic-vagal reflex and increased intestinal enzymes secretion.      The objectives of this study are to evaluate effects of adding gum chewing to the     conventional postoperative feeding protocol on the return of bowel function, its related     complications, and patients' satisfaction.   "
144732|NCT01389973|"     The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients     with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.   "
144733|NCT01389947|"     Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients,     mesenteric ischemia appears even when macrocirculatory parameters are controlled especially     in our experience in patients coming in ICU after a cardiac surgery. The investigators     suppose that microcirculatory failure develops and results in suffering of non major organs     like muscle, skin and digestive tracts. In this study the investigators monitor digestive     tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT and     plasma glycocalyx measurements. The population is composed by patients having coronary artery     bypass during cardiopulmonary bypass.      The first aim of this study is to show that digestive tract is suffering with the use of     extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding     Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will     be less than 20 micromol/L.      The second aim is to investigate link between endothelial dysfunction and digestive tract.     Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after     a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve,     resaturation curve and hyperemic response by measurement of area under curve). Endothelial     glycocalyx and NO pathway will be investigate (see under)      Our objective is to enroll 100 patients. The same study will be done in a group of patients     who benefit from coronary artery bypass without extracorporeal circulation to see the effects     of extracorporeal circulation support.   "
144734|NCT01389934|"     Background: The use of local anesthetics as a supplement to conventional techniques in breast     surgery is widely reported in the literature. Currently there is controversy regarding the     efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this     study demonstrate the efficacy of administering a local anesthetic into the surgical bed of     women operated radical mastectomy for breast cancer for the control of postoperative pain.      Material and methods: double-blind randomized clinical trial. The investigators recruited     patients who underwent modified radical mastectomy that met inclusion and exclusion criteria.     The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline     control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic     and rescue medication was identical in both groups.      Statistical analysis: The baseline patient characteristics of the patients were analyzed by     Chi square or Student t always meet criteria of normality, otherwise it will use the     Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse     events will be held on chi-square test.   "
144735|NCT01389921|"     The purpose of this study is to investigate afferent and cortical activities during bladder     filling under different stimulations of the lower urinary tract. The participants of the     study are healthy test persons and patients with overactive bladder.   "
144736|NCT01389908|"     The purpose of this study is to assess the long-term efficacy of Olanzapine Pamoate (OP)     Depot in patients diagnosed with schizophrenia or schizoaffective disorder.   "
144737|NCT01389895|"     This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose     study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of     12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo.     Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140     mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of     Cohort 1 (210 mg) is completed.   "
144738|NCT01389882|"     The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist     (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory     oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison     with currently used standard ventilation (synchronized intermittent mandatory ventilation     with pressure-support ventilation, SIMV+PSV).   "
144742|NCT01389830|"     Objectives:      The primary objective of the research project is to investigate how declining health status     influences the end-of-life (EOL) treatment preferences in Latino Medicare beneficiaries with     cancer and to examine if and how these preferences are modified by predisposing     characteristics (i.e., acculturation, education, medical mistrust, perceived racism) and/or     provider-related characteristics (i.e., ethnicity, language used, provision of interpreters,     or patient navigators). The specific aims are:        1. To determine if declining functional status influences the end-of-life treatment          preferences of older Latino Medicare beneficiaries with cancer.        2. To determine if predisposing characteristics (i.e., acculturation, age, education,          medical mistrust, perceived racism) and/or provider-related characteristics (i.e.,          ethnicity, language used, provision of interpreters, or patient navigators) modify the          association between end-of-life treatment preferences and declining health status in          older Latino Medicare beneficiaries with cancer.        3. To identify if the end-of-life treatment preferences of Latino Medicare beneficiaries          with cancer differ from those of older Medicare beneficiaries without cancer.   "
144743|NCT01389817|"     The overall objective of the proposed research is to test the hypothesis that Near-infrared     Light-emitting Diode (NIR-LED) therapy will stimulate mitochondrial function, attenuate     oxidative stress, and improve cell survival and vision in subjects with Leber's Hereditary     Optic Neuropathy (LHON).   "
144744|NCT01389804|"     The overall long term objective of this research is to improve health care utilization and     quality of life of pediatric solid organ transplant recipients and family. Understanding the     process of transition to a chronic medical condition during the acute (3 weeks after     transplant) and long term (3 and 6 months) will significantly guide the development of     clinical interventions aimed at maximizing adherence and family psychosocial adjustment.   "
144777|NCT01389375|"     Are novel vascular closure devices noninferior to manual compression regarding access site     complications after coronary angiography?   "
144746|NCT01389778|"     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age     women. Women with PCOS have a high risk of prediabetes, type 2 diabetes and heart disease.     The investigators have found a possible change in the DNA (genes of the body that encode all     of our traits) that seems to be related to insulin resistance. In this study, the     investigators will try to determine whether the change in the gene affects a woman's ability     to respond to a common treatment for PCOS, metformin.      These studies will uncover the change in a gene that might be one of the causes of PCOS.     Discovering this gene will help better understand the diabetes and insulin abnormalities that     are common in PCOS and will help us to better diagnose and treat PCOS to prevent the diabetes     in these women.   "
144747|NCT01389765|"     This study will evaluate the effect of food on LY2216684. There will be 2 study periods each     lasting up to 5 days. There will be at least 7 days between the two doses and a follow up     will occur at least 7 days after the last dose. Screening is required within 30 days prior to     the start of the study.   "
144748|NCT01389752|"     The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2     occasions, once with activated charcoal and once without activated charcoal.      The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects     will be documented. There will be 2 study periods each lasting up to 5 days. There will be at     least 7 days between the two doses and a follow up will occur at least 7 days after the last     dose. Screening is required within 30 days prior to the start of the study.   "
144749|NCT01389739|"     Many authors have recognized the need to overcome the different barriers to continuity of     cancer care, such as inadequate communication between specialists and family physicians (FP),     insufficient information provided for the long-term follow-up care and difficulties to     transfer back to FP the responsibility for cancer care at the end of treatments. This study     aims to assess the effectiveness of a multi-faceted intervention to improve continuity of     care for patients with lung cancer. Newly diagnosed lung cancer patients who have a FP will     be randomly assigned to either the intervention group or to usual care and they will be     followed at baseline, 3, 6, 9, 12, 15 and 18 months ( or until death for those with a     survival of less than 18 months). The intervention comprises 4 components: 1) systematic     appointments with FP at 3-month interval ; 2) transmission to FP of a standardized     comprehensive summary before each appointment; 3) systematic transmission to the oncology     team of patients' information resulting from FP visits; 4) development of a priority access     to FP for cancer patients. In both groups, outcomes related to patients and to care processes     will be measured at baseline and then after 3, 6, 9, 12, 15 and 18 months (or until death for     those with a survival of less than 18months). Patients' principal family caregiver will be     invited to participate to the study and they will complete questionnaires at baseline, at 6     months and at the end of the study. In addition, patients' FP will also be invited to     complete a questionnaire at baseline and at the end of the study.   "
144750|NCT01389726|"     This study is a multi-site, four-year long clinical trial study in which several mental     health interventions will be delivered to custodial grandmothers and then compared. The study     will examine effects on the mental health of these grandmothers and the grandchildren they     provide full-time care to in complete absence of the grandchild's birth parents. Grandparents     from diverse racial, ethnic, and socio-economic backgrounds will be recruited to test for     cultural differences in response to these interventions. This study is important because     there is growing evidence that custodial grandchildren are at-risk for psychological     difficulties due to neglect and abuse by birth parents, challenges to parenting faced by     custodial grandparents, and limited access to needed services. This study is funded by the     National Institute of Nursing Research, a division of the National Institutes of Health, and     it is anticipated that more than 500 custodial grandfamilies in four sites across the United     States will partake.   "
144751|NCT01389713|"     Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent     a demanding challenge for clinicians. It has classically been claimed that using higher     dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation     and increase the chances of success. However, scientific evidence supporting this view is     scanty and costs are inevitably much higher. In this study, the investigators hypothesized     that similar chances of pregnancy may be achieved with a mild stimulation using exclusively     Clomiphene citrate (CC).   "
144752|NCT01389700|"     Primary Objective:      - To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356     administered to intensive care unit (ICU) patients on mechanical ventilation      Secondary Objectives:        -  To determine the safety and tolerability of SAR279356        -  To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356        -  Exploratory efficacy of SAR279356 on prevention of bacterial infections   "
144753|NCT01389687|"     The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose     primary and booster vaccination in Japanese infants aged 3 through 68 months.      Primary objective:        -  To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90%          approximately one month following the three dose primary vaccination series with          inactivated polio vaccine (IPV).      Secondary objective:        -  To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine          response rates and Geometric Mean Titers) of IPV before and after the primary          vaccination and before and after the booster vaccination.        -  To describe the safety after each dose of IPV.   "
144754|NCT01389674|"     The investigators will check the feasibility of an intraprocedural vitality diagnostics and     the identification of an indication for Percutaneous transluminal coronary angioplasty     (PTCA).   "
144826|NCT01388738|"     Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's     very important to choose the right way of the management of the patient and an appropriate     drugs.      There is a large number of the so-called neuroprotective drugs, which were effective in     laboratory, but didn't show positive results in clinical studies with using traditional     clinical scales scores as a primary outcome measures.      Specialists suggest, that the investigators could receive better results if the investigators     change design of the studies, particularly if the investigators select more precise and     sensitive method of assessment.      Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation     of the changes in the motor centers and motor tracts after administration of different     cerebroprotective drugs. (The substances won't be compared to each other).   "
144755|NCT01389661|"     This trial pretends to validate for clinical use a bioengineered product composed of MSV     cells (mesenchymal stem cells produced by IBGM, Valladolid, which have already been approved     by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked     matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/     119855) for bone maxillary cysts refilling. These two groups collaborate in the present     project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega,     who leads the clinical trial and deals with the medical aspects. The proposed trial is based     on positive results obtained in previous animal studies performed by the present     multidisciplinary team. The investigators propose a phase I / II clinical trial with 10     patients suffering from bone cysts in the maxillofacial region. Autologous mesenchymal stem     cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and     cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity     filled with the protein matrix containing the mesenchymal cells. Checks will be conducted at     3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and     computerized tomography scan.   "
144756|NCT01389648|"     The purpose of this study is to assess the roll of pre-operative chest physiotherapy, in     addition to the usual care given after major abdominal surgery, in the prevention of     post-operative respiratory complications.   "
144757|NCT01389635|"     Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among     the most hazardous aesthetic procedures currently performed. It was shown, in many studies,     to be associated with a significant complication rate, some of which are life-threatening.     This study describes the investigators experience with a series of abdominoplasties performed     under epidural anesthesia. Outcomes are presented, especially in terms of complication, and     the practical advantages of this method are discussed.   "
144758|NCT01389622|"     Auricular acupressure has been practiced in China and Germany to help people in smoking     cessation programs. The purpose of this clinical trial is to test for the clinical     effectiveness of self-administered auricular acupressure as a non-invasive method for smoking     cessation.   "
144759|NCT01389609|"     To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water     to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition   "
144760|NCT01389596|"     Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter     study to evaluate the safety and efficacy of two dose levels of pregabalin administered in     equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive     therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.   "
144761|NCT01389583|"     A Phase II Study of AUY922, Novel HSP Inhibitor, in Patients with Advanced GIST Failed to or     Intolerance of Imatinib and Sunitinib Therapy      Primary endpoint:      •The primary endpoint of this study is to assess disease control rate (complete response +     partial response + stable disease≧4 months) of AUY922 in patients with advanced GIST failed     to imatinib and sunitinib      Secondary endpoints:        -  To determinate the objective response rate (ORR, complete response + partial response)        -  To determinate the time to tumor progression (TTP)        -  To evaluate the safety and toxicity profiles of AUY922        -  To evaluate the pharmacokinetics profile of AUY922 in Taiwan GIST population        -  To access the pharmacodynamic effect of AUY922 on HSP client proteins in blood and tumor          if feasible , i.e. HSP70, in Taiwan GIST population        -  To access the tissue biomarkers pre-treatment and 4wks post treatment if feasible, i.e.          HSP70, c-KIT, PDGFRA mutation, ...etc in Taiwan GIST population      Exploratory endpoints:      •PET imaging; sSUVmax   "
144762|NCT01389570|"     Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.     However, pharmaceutical prophylaxis can confer unpleasant adverse effects. It would therefore     be appropriate to consider the use of non-pharmacological methods in preventing PONV.     Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and     the adverse effects are minimal. Consequently, the aim of the study is to implement     acupressure in our anaesthetic department procedures. A reduction of the use of antiemetics     will be a parameter on the effectiveness of acupressure. The study will focus on acupressure     as a supplement to the ordinary prophylactic treatment of PONV in adults undergoing     orthopaedic and general surgery, and adults and children undergoing ear, nose, throat     surgery. The primary endpoints are the quantities of antiemetics used before (baseline) and     during the implementation period. The study will be conducted from January to December 2011.   "
144763|NCT01389557|"     Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping     malaria transmission. The addition of primaquine (PQ) - the only drug commercially available     that kills mature transmission stage - to such treatments might be necessary to eliminate     this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine     (DHP) regimens with PQ on malaria transmission on a community wide level in Lempasing,     Lampung, Sumatra.   "
144765|NCT01389531|"     The aim of the study is, primarily, evaluate the safety of the use of the silicone stent     HCPA-1 in patients with clinically significant tracheal and/or bronchial stenosis.     Secondarily, this study aims to evaluate the efficacy of the use of the silicone stent HCPA-1     who are in the same conditions described above and also estimate the costs the use of these     silicone stents involve.   "
144766|NCT01389518|"     The aim of this study is to evaluate the efficacy and safety of a fixed combination of     paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and     flu-like illness in adults in a randomized, double-blind, controlled trial. The investigators     included 146 healthy study subjects aged between 18 and 60 years who presented flu or common     cold moderate to severe onset of less than 3 days (72 hours). After clinical and laboratory     evaluation were randomized to receive active drug or placebo, five capsules a day, every 4     hours for 48-72h.The outcomes to assess the effectiveness involve the measurement of symptom     scores, overall duration of symptoms, return to usual activities, use of rescue medication,     improvement of the fever.   "
144827|NCT01388725|"     The purpose of this study is to describe the value of serum sTREM (soluble triggering     receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP)     concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical     informative value in predicting outcome.   "
144767|NCT01389505|"     This is a prospective, randomized and comparative study is to quantify the functional and     structural alterations of the macula in patients with proliferative Diabetic Retinopathy     submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab     as a adjuvant therapy in preventing the adverse events of that procedure. The patients with     proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation     will be examined by ophthalmologists who will measure the visual acuity and contrast     sensitivity, perform slit lamp examination, fundus examination and optic coherence tomography     before and after laser photocoagulation. Laser photocoagulation will be performed in both     eyes according Early Treatment Diabetic Retinopathy Study that advocate the realization of 3     episodes of laser photocoagulation in 3 weeks. This comparative study analyses the effect of     intravitreal bevacizumab one week before laser photocoagulation and one, three and six months     after the randomization visit. The fellow eye will be submitted only to laser     photocoagulation and will be considered as control. It is estimated a sample of 30 patients.     All procedures, purposes and methods will be explained to all patients.   "
144768|NCT01389492|"     The postprandial increase in MDA level following meat meal could cause modification to LDL     particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will     result in a significant decrease in LDL modification.   "
144769|NCT01389479|"     The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™     in healthy adults aged 18-64 years.   "
144770|NCT01389466|"     This study was designed in two steps with Step 1, a single-center, double-blind, randomized     clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal     study. The investigator evaluate the immunogenicity and safety of the investigational vaccine     in the subjects during their participation in the study.   "
144771|NCT01389453|"     All experimental group patients of 100 patients accept a treatment course stem cell     transplantation, including one time stem cell transplantation through intravenous injection     way at the 10-21th day of cerebral hemorrhage, and the 7—14th day of cerebral infarction     incidence; the second time transplantation through lumbar puncture way at the 7th day after     the First time transplantation. The control group gives injection through intravenous and     lumbar puncture ways separately in the corresponding time, but the transplantation matter is     physiological saline not the stem cell.   "
144772|NCT01389440|"     This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of     Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by     gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy /     day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to     assess the percentage of R0 resections. They have planned a total of 21 visits.   "
144773|NCT01389427|"     This is a multicenter, open label, three arms, Phase IB study.      A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2,     day 8 and day 15 in combination with three chemotherapies regimens for patients in     relapsed/refractory Mantle Cell Lymphoma (MCL):        -  Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered          every 3 weeks for 6 cycles,        -  Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles,        -  Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6          cycles.   "
144774|NCT01389414|"     This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of     panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX).     Eligible subjects will be enrolled and randomized to receive first-line combination therapy     consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame     of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX)     combination compared to GEMOX alone in patients with previously untreated surgically     unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety     profile of the P-GEMOX combination; to assess the objective response rate; to assess overall     survival; to study the correlation between biomarkers with activity and efficacy.   "
144775|NCT01389401|"     -  Saliva plays a key role in the homeostasis of the digestive tract        -  The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal          and pharyngeal mucosas        -  There seems to be no correlation between the severity of reflux episodes and the          intensity of inflammatory changes, suggesting individual protective mechanisms to          refluxate exposure        -  Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux          Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis          (Laryngopharyngeal Reflux- LPR)        -  Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in          patients with GERD and LPR, but it is unclear if these are primary or secondary to the          disease.        -  Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis          is primary and therefore would not change after treatment and control of the disease   "
144786|NCT01389258|"     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 3mm     diameter implant in a Chinese population by evaluation of marginal bone level alteration,     implant stability and implant survival in the posterior maxilla up to 3 years after loading.     Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.   "
144776|NCT01389388|"     Patients with rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) are at greater risk     of developing cardiovascular disease. The reason(s) for this have not been well investigated,     but there is a general understanding that systemic inflammation plays a part in the increased     cardiovascular morbidity and mortality. In spite of the increased risk in these patients,     they have not been included as a high risk patient group in cardiovascular prevention     guidelines.      The investigators have carried out a cardiovascular study of RA and AS patients, as well as     patients with arthritis for the first time. The investigators have demonstrated cholesterol     plaques in the carotid artery in some of these patients. Plaques in the carotid artery     represent a risk for development of cerebral stroke and are significantly associated with     myocardial infarction. These plaques, which are asymptomatic and do not cause     haemodynamically significant narrowing, diameter reduction (i.e. operation is not indicated),     are vascular atheromatous disease. Therefore, according to prevailing cardiovascular     guidelines (SCORE 2007), these patients shall have secondary prevention with a lipid lowering     agent with the LDL-cholesterol goal of 1.8 mmol/L and HDL-cholesterol > 1.0 mmol/L for men     and > 1.1 mmol/L for women.      Statins are cholesterol-lowering drugs, and have been shown to reduce the risk of     cardiovascular disease significantly. In addition, reduction in the size of coronary plaques     has been induced by statins, when the LDL has been reduced to 1.6-1.8 mmol/l. Plaques in the     carotid or coronary arteries have not previously been treated and characterized in patients     with RA, AS and other inflammatory forms of arthritis.      The aim of this study is to treat patients with cholesterol plaques in the carotid artery     with cholesterol-lowering medication, in the form of Rosuvastatin for 18 months, and     characterize the effects on the plaques in the carotid and coronary arteries. In addition,     the investigators want to clarify the connection between plaques in the carotid and coronary     arteries in patients with RA, AS and other inflammatory forms of arthritis.   "
144778|NCT01389362|"     There is now a global epidemic of diabetes and obesity affecting more than 300 million people     worldwide with Asia in the forefront. In Hong Kong, diabetes affects more than 10% of the     population. Patients with diabetes have a 12—25% lifetime risk of developing a foot ulcer.The     abnormal metabolic milieus of hyperglycemia, hyperlipidemia, hypertension, pro-thrombotic     state and chronic inflammation in diabetes causes atherosclerosis.A significant proportion of     subjects have underlying peripheral arterial disease and neuropathy. These subjects are at     great risk of developing infective foot ulceration secondary to impaired vascular supply,     sensory loss and minor trauma.Without prompt and proper medical treatment, these infective     ulcers will deteriorate leading to gangrene and limb amputation. In-vitro and in-vivo studies     revealed that 5 out of the 12 herbs were effective in promoting fibroblast proliferation and     angiogenesis. To minimize potential drug interactions and adverse effects from multiple     components in a recipe of Traditional Chinese Medicine (TCM), the investigators have     developed a simplified formula from the 12 herbs consisting of only two herbs. In this     proof-of-concept study, the investigators hypothesize that the novel recipe of herbal     medicine will expedite healing of early foot ulcer by promoting vascularisation and     granulation as well as modulating inflammatory response.   "
144779|NCT01389349|"     Pain after tonsillectomy can be severe and last ten days.      Various new surgical instruments have been developed over the years in an attempt to reduce     postoperative pain with mixed results and increased costs; no single tonsillectomy technique     is superior to the rest. Patients are discharged to home usually on the day of surgery and     often suffer significant pain and nausea. Pain medication is often prescribed which can cause     nausea, vomiting and constipation. Children in pain are reluctant to take in fluids and may     require intravenous hydration at an emergency department.      Battlefield acupuncture  has been recently developed by the US Air Force and is now being     used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma.     This protocol consists of five acupuncture points on the outer ear.      A recent study has demonstrated decreased pain and agitation in children undergoing ear tube     insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are     able to attend school the next day.      The investigators have been encouraged by the benefits of acupuncture during surgery for ear     tube patients and also wounded warriors recovering from their injuries. These findings     motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and     nausea.   "
144780|NCT01389336|"     The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic     diagnosis and treatment compared to conventional standard care alone in stationary patients     with Fibromyalgia Syndrome.   "
144781|NCT01389323|"     The purpose of this study is to compare the rates of sustained virologic response in each     cohort (Black-African Americans, Latinos) in this study to historical rate.   "
144782|NCT01389310|"     The purpose of this study is to monitor adverse events in HIV-infected children <18 years old     who are exposed to Atazanavir in a real-world setting in Europe.   "
144783|NCT01389297|"     The objective of this research project is to develop, evaluate, and disseminate an     Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be     based on the four point cognitive-behavioral program for SMART Recovery     (www.smartrecovery.org). The goal of the OA program is to help users learn cognitive and     behavioral skills to abstain from drinking, drug use, and problem gambling.      The investigators will evaluate the effectiveness of the OA web application for heavy     drinkers in a randomized clinical trial (RCT) with follow-ups at 3- and 6-months.      The study design has three conditions: 1) participation in face-to-face SMART Recovery     meetings alone; 2) use of the OA web application as a stand-alone intervention; and 3)     combining the OA web application with participation in face-to-face SMART Recovery meetings.      Study Hypotheses:        1. All three groups will reduce their alcohol consumption, drug use (if any), and          alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month          post-baseline assessments.        2. The OA only group (Experimental group 1) will show a greater reductions in drinking,          drug use (if any), and alcohol/drug-related problems relative to the face-to-face only          (Control) group.        3. The OA + face-to-face group (Experimental group 2) will have better outcomes on drinking          and drug use variables compared to the Control group.   "
144784|NCT01389284|"     The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg     tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with     postsurgical dental pain.   "
144785|NCT01389271|"     This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in     the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with     primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial     hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class     and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and     tolerability of the drug and the survival of the patients will be observed.   "
144787|NCT01389245|"     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX implants     in a Chinese population by evaluation of marginal bone level alteration, implant stability     and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early     loading of the posterior maxilla is a safe and predictable procedure.   "
144788|NCT01389232|"     This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in     breast reconstruction surgery.   "
144789|NCT01389219|"     Introduction of a community-based intervention package including prevention strategies, early     recognition and management of common postpartum & neonatal problems, as well as prompt     referral of high risk/complicated cases through trained first level primary health care     workers, will result in a significant reduction in Postpartum maternal and neonatal mortality     in Pakistan   "
144790|NCT01389206|"     This program intends to improve the management of pulmonary arterial hypertension (PAH)     patients through an evidence-based approach aimed at achieving optimal World Health     Organization (WHO) functional class (FC): 1. Improving FC III & IV patients to FC II, 2.     Improving FC II patients to FC I, and 3. Maintaining FC II & FC I patients.   "
144913|NCT01387607|"     The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared     with placebo for management of fibromyalgia in adults.   "
144791|NCT01389193|"     This will be a double-blind, randomised, placebo-controlled, two period cross over study of     ibudilast in the treatment of chronic migraine.      For participants resident in Adelaide, South Australia (i.e. local participants):      The study will involve a screening visit followed by eight visits to the Pain and Anaesthesia     Research Clinic (PARC), within the Royal Adelaide Hospital (RAH), for baseline testing,     initiation of the study medications and ongoing data collection (one baseline and three study     visits during each treatment period).      At the baseline visit, blood samples to assess biomarkers (glutamate, calcitonin gene-related     peptide, glial fibrillary acidic protein and S100β) will be taken. Patients will then be     randomised (in a 1:1 ratio) to commence either ibudilast or placebo treatment, which will     continue for 8 weeks. Subsequently participants will undergo a 4-week washout period. At the     end of the washout period a second 8-week treatment block with the alternative treatment will     commence.      Patients will complete a headache diary daily for at least 4 weeks prior to the baseline     visit, throughout the treatment and washout periods and for 4 weeks after treatment ceases.     The diary will record headache frequency, duration, intensity, pain characteristics and     medication intake for comparison with baseline data.      From screening until the final study visit (over a minimum of 6 months) a total of     approximately 200 mL in blood samples will be taken from each local participant.      For participants located in country or interstate locations:      The same study will be undertaken, but instead of attending the Pain and Anaesthesia Research     Clinic (PARC), within the Royal Adelaide Hospital (RAH) for screening and study visits, these     will be managed remotely through:      basic input from the participant's GP during the screening period correspondence with the PI     and study staff via registered post, phone or Skype scheduled visits to the nearest pathology     collection centre for blood biochemistry and haematology analysis      Interstate or country participants will also be exempt from collection of blood samples for     biomarker analysis, hence a total of approximately 120 mL of blood samples will be taken from     each interstate or country participant.   "
144792|NCT01389180|"     This study will provide critical data regarding the efficacy for reducing drug-and     sex-related HIV transmission risk behaviors, as well as improving methadone maintenance     treatment (MMT) outcomes and patient functioning of two transportable counseling models,     behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as     compared with the current standard of care model in MMT in China. Evidence-based counseling     that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT     will greatly improve the public health benefits of disseminating MMT in China and elsewhere     in the world.   "
144793|NCT01389167|"     The long-term goals of this study are to foster development and dissemination of     evidence-based behavioral and pharmacological treatments to reduce HIV transmission,     injection drug use (IDU), and heroin use in Russia. This study will examine the effects of     combining behavioral therapy with naltrexone pharmacotherapy for the treatment of opiate     dependence and reduction of HIV risks in opiate dependent individuals. Specifically the study     will determine whether extended-release injection naltrexone has greater efficacy and is more     cost-effective than oral naltrexone maintenance, whether behavioral drug and HIV risk     reduction counseling (BDRC) combined with brief, medical management (MM) has greater efficacy     and is more cost-effective than MM only, and whether particular combinations of medication     formulation and counseling (MM only or MM plus BDRC) have greater efficacy or are more     cost-effective than other combinations.   "
144794|NCT01389154|"     The objective of the prospective, multi-center study is to evaluate the ease of use and     effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a     method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and     beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of     similar published historical controls using conventional bronchoscopy.   "
144795|NCT01389141|"     The investigators hypothesize that age-related changes in the number and growth dynamics of     ovarian follicles will be associated with changes in hormone levels and corresponding changes     in musculoskeletal health.   "
144796|NCT01389128|"     The proposed project will be conducted to evaluate the influence of application resources     associated with non-pharmacological during labor for pain relief and accelerated phase of     expansion. Although mothers' access to resources for non-pharmacological pain relief during     labor is recommended, is not seen as the application of routine obstetric practice, although     it has been demonstrated benefits and scientific evidence with your application. It is     believed that the implementation of this protocol based on the application of     non-pharmacological resources in assisting the labor can be introduced into daily practice in     various hospitals in the country, minimizing pain and favoring the shorter duration of labor,     decrease in use of painkillers and inductors, resulting in a reduction of complications,     improves the comfort of the mother making her birth experience more satisfying and rewarding,     being assisted with security and trained by multidisciplinary teams.   "
144797|NCT01389115|"     The purpose of this study is to determine lipid metabolism in chronic liver disease in the     attempt to find a useful biomarker of liver function and of prognostic value of graft     function in those patients who undergo liver transplant. The present study enrolls subjects     with liver cirrhosis (with different ethiology), including subjects eligible for a full-size     liver transplantation, and healthy controls.   "
144798|NCT01389102|"     Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in     postmenopausal women. This study will evaluate the safety and efficacy of Evamist.   "
144799|NCT01389089|"     Edema control after ankle- and hindfoot fractures is important. Multi-layer compression     bandages or A-V Impulse compression may are more effective in reducing edema than ice.   "
144823|NCT01388777|"     Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and     destroy cancer tissue.      The goal of this clinical research study is to learn about the level of effectiveness of     using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of     this procedure will also be studied.   "
144800|NCT01389076|"     Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet had     previous systemic treatment, such as chemotherapy or immunotherapy will be invited to     participate. This research study is being conducted in order to evaluate the combination of     lowdose methotrexate and Iodine I 131 tositumomab (Bexxar) with regards to whether the     combination will reduce the occurrence of the HAMA (Human Anti-Mouse Antibody) response. HAMA     is an immune reaction against the tositumomab protein. Symptoms arising from HAMA can range     from a mild form, like a rash, to a more extreme and possibly life-threatening level. HAMA     can also decrease the effectiveness of the treatment, or create a future reaction if a     patient is given another treatment containing mouse antibodies. In addition to evaluating the     occurrence of HAMA, this research study will also look at the short and long-term     effectiveness of this combination in the treatment of lymphoma, as well as its safety.   "
144914|NCT01387594|"     Study is designed to show a lack of effect on white blood cells circulating in the spinal     fluid.   "
144801|NCT01389063|"     HIV infected patients treated with abacavir might have a higher risk for the occurrence of     cardiovascular events. At time of writing of this protocol the underlying mechanism is not     yet elucidated, however some studies find impaired endothelial function and elevated markers     of chronic inflammation in these patients,suggesting a higher lever of chronic inflammation.     Recently maraviroc (Celsentri®), a CCR5-receptor antagonist, became available for treatment     of patients infected with HIV-1.      Improvement of endothelial function may be a potential beneficial side effect of treatment     with maraviroc, due to the potential reduction of immune activation and chronic inflammation     as a result of blocking the CCR5-coreceptor. Moreover, treatment intensification of HAART     with maraviroc in patients with suppressed plasma HIV_RNA may decrease plasma HIVRNA below     the cut-off of 50 copies/ml as well.      The investigators hypothesize that maraviroc intensification therapy in patients on an     abacavir-containing regimen will improve endothelial function.      The objectives of this study are: First, to assess the effect of addition of maraviroc to an     abacavir-containing regimen on endothelial function; second, to assess the effect of this     intervention on markers of immune activation and chronic inflammation, and on plasma HIV-RNA     below 50 copies/ml.   "
144802|NCT01389050|"     This research study aims at defining 1) how retroperitoneal sarcomas change over the course     of radiotherapy and 2) how radiotherapy affects your well-being. While the investigators know     that radiotherapy before surgery is safe and effective, the amount of tumor motion and size     change during radiotherapy is unknown. There is also very little information that describes     the side-effects of radiotherapy in the treatment of this disease.   "
144803|NCT01389037|"     This clinical trial focuses on helping African Americans with high blood pressure to manage     their disease. The study will target their ability to read and understand health information     (also called health literacy). The research method relies on community participation in equal     partnership with the researchers to provide interactive workshops and home blood pressure     self-monitoring with the assistance of telephone counseling by community health workers.   "
144804|NCT01389024|"     This is a pilot study of hydroxyurea versus placebo to reduce central nervous system     complications (abnormally fast blood flow to the brain, silent cerebral infarct or stroke) in     young children with sickle cell disease. The investigators plan to identify children 12 to 48     months old without central nervous system complications and randomly assign 20 to treatment     with hydroxyurea and 20 to treatment with placebo for 36 months. Neither the study doctors     nor the participants will know which treatment they are receiving.   "
144805|NCT01389011|"     The purpose of this study is to:        1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth          variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after          induction of general anesthesia.        2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and          non-anesthetized limb.   "
144806|NCT01388998|"     Fluid therapy optimization in the perioperative period has been considered as major     contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid     requirements in the anesthetized patient with arterial line is the assessment of difference     in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid     management approach to avoid both hypervolemia and hypovolemia. However, several clinical     factors may impede dPP measurements. Surgical manipulations in abdominal procedures may     interfere with hemodynamic stability due to obstruction of the caval vein. Physiological     considerations make us hypothesize that only intense pressure impedes caval blood flow and     thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after     standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval     vein.   "
144807|NCT01388985|"     Rabies is a viral zoonosis that causes an encephalitis, almost invariably fatal. It is widely     distributed across the globe: the World Health Organization (WHO) estimates that about 2,4     billion people live in endemic areas for canine rabies. Vaccination of domestic animals is     limited to industrialized and middle-income countries.      The development of clinical rabies can be prevented through timely immunization after     exposure: however, preventive vaccination simplifies the post-exposure procedure     considerably, as immunoglobulins are no longer needed and less vaccine administrations are     scheduled. Pre-exposure prophylaxis consists of an intramuscular (IM)of intradermal (ID) dose     given on days 0, 7 and 21 or 28. The development of immunological memory after this     vaccination is critical for the establishment of long lasting immunity. Subjects receiving a     booster dose 1 year after pre-exposure prophylaxis segregate themselves into 'good' and     'poor' responders; the former may not need further boosters for 10 years, whereas the latter     may need more frequent boosters.      Until recently, guidelines in travel medicine recommended pre-exposure vaccination only for     some risk groups. Since recent studies have shown the effectiveness of the ID vaccination,     the policies are changing towards pre-exposure vaccination for a larger population, including     travelers to endemic regions, where immunoglobulins and vaccine are often not readily     available.      Based on the above, the investigators must stress the concept of boostability after a risk     exposure. However, the current pre-exposure vaccination scheme could be improved: a schedule     of 1 week would be less time consuming, would improve compliance and give less interference     with other prophylaxis measures, e.g. mefloquine. Two small studies suggest that a schedule     of 1 week interval is as effective and immunogenic as the standard one.      The investigators will investigate whether the accelerated schedule is as effective as the     classical schedule, by carrying out a randomized, non-inferiority study.   "
144824|NCT01388764|"     The purpose of the study is to assess the safety, tolerability, and effects of L-Arginine on     muscles in boys with dystrophinopathy on corticosteroids. Specifically, to see if L-arginine     reduces muscle signal abnormalities on MRI done pre and post 30 days of L-arginine     administration.   "
144825|NCT01388751|"     Do patients that night splint for 1 month after 6-8 weeks of continuous splinting for a     mallet injury have the same extensor lag 4 months after initiating treatment as patients that     do not perform night splinting?      Secondary Question: Is night splinting a predictor of DASH score or patient satisfaction (on     a 5-Point Likert scale)?   "
144839|NCT01388569|"     RATIONALE: Studying samples of blood from patients treated with sargramostim in the     laboratory may help doctors learn more about the effects of sargramostim on cells. It may     also help doctors understand how patients respond to treatment.      PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV     melanoma previously treated with sargramostim.   "
144895|NCT01387841|"     -  This randomized controlled three arm study compares the effects of a yoga intervention          with jacobsons progressive muscle relaxation training and only standard of care in          chemotherapy naive cancer patients.        -  This study will also assess the neurophysiological correlates of nausea and vomiting and          assess if effects of intervention on nausea and vomiting outcomes are mediated by          changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic          function and sympathetic skin response) or self reported anxiety.   "
144808|NCT01388972|"     Several environmental factors have contributed to the growing pandemic of obesity. It has     been described that some characteristics of food and built environment have an influence on     patterns of food consumption and physical activity of people in a certain place.      We have designed a cross-sectional study to describe some aspects of the food environment     (community and consumer) and the frequency, distribution and characteristics of the space     available to perform physical activity in three neighborhoods of Buenos Aires city.      Three neighborhoods of Buenos Aires (with representativity), from different socioeconomic     strata, will be selected by convenience to conduct this study.      The study will consist on three stages: first, the generation of the sampling frame of food     stores, public and private spaces available for carrying out physical activity, and the     development of a tool designed to evaluate the availability of healthy foods in supermarkets     and grocery stores. Finally, a sample of those stores will be randomly selected for assessing     the availability of selected foods.      In Argentina, the knowledge of the food environment is limited. We believe that the     information obtained in this study will contribute to a better understanding of the subject.   "
144809|NCT01388959|"     This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of     MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal     residual disease after autologous haematopoietic stem cell transplantation (bone marrow or     peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients     with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal     B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2     intravenously once every week. The anticipated time on study treatment is 4 weeks.   "
144810|NCT01388946|"     The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients     undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the     analgesic consumption during the first 24 hours.   "
144811|NCT01388933|"     The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the     treatment of Crohn's disease.   "
144812|NCT01388920|"     A significant proportion of COPD subjects experience muscle wasting, which has been     associated with increased morbidity, impaired physical functioning, and a poor quality of     life.      Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular,     weakness of peripheral muscles has been reported to play an important role in the reduced     functional capacity and impaired exercise performance.      The primary objective of this study is to investigate the effect of tesamorelin, in     conjunction with exercise training, on lean body mass measured by dual energy x-ray     absorptiometry (DXA) scan.   "
144813|NCT01388907|"     The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the     prevention of adhesions in gynaecologic surgery, and to assess post-operative complications     related to adhesions and pregnancy rate after myomectomy by open surgery.   "
144814|NCT01388894|"     Patients who report that exposure to bright light or strenuous physical activity will induce     migraine aura will be provoked using one or both of these methods. Followingly the patients     will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography     will be performed as well. The primary study hypothesis is that the functional MRI signal     will show features similar to those of the electrophysiological phenomenon of cortical     spreading depression.   "
144815|NCT01388881|"     The main objective of this study is to evaluate the effectiveness of music education over a     period of five months (three times per week, one hour per day) on the improvement of reading     skills (decoding, prosody and phonological awareness) in children (8-10 years) with reading     difficulties from poor neighborhoods in the city of Sao Paulo. A second objective is to     develop a theoretical model that may explain how acquired musical skills are correlated with     the supposed changes in each of the covariates and outcomes in this study.      The study will be administered to 270 children with reading difficulties from 10 different     schools (27 children per school). 135 children will have music lessons and 135 will not;     therefore, 5 schools will be the control and 5 schools will be the intervention group. The     analysis will consider the cluster structure, since the randomization was not conducted at     the individual level (i.e., the school level was the randomization unit). For the inferential     analysis, generalized estimation models and structural equation modeling will be used.   "
144816|NCT01388868|"     The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery     is essential for intraoperative motor-evoked potential monitoring. However, the precise     strategy of administering neuromuscular blocking agent for obtaining that goal has not been     established. Therefore, the investigators tried to find the optimal initial dose of     vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by     neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).   "
144817|NCT01388855|"     The purpose of this study is to determine if the methods are feasible for a larger clinical     trial.The study will examine the relationship between vitamin D status, quality of life, pain     and walking distance of individuals living with heart failure.   "
144818|NCT01388842|"     The purpose of this study is to assess if adding inhaled Nitric Oxide to other malaria     treatments can improve the outcome of cerebral malaria in children aged 2months to 12 years.   "
144819|NCT01388829|"     This study is designed to compare the pharmacokinetics of two different lots of tablets.   "
144820|NCT01388816|"     The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in     elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein     cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for     heart disease.   "
144821|NCT01388803|"     A retrospective study to demonstrate the optimal depth of right side bronchial blocker for     complete right lung separation. Data were collected from all patients who completed right     side VATS with right side BB from Jan 2010 through Nov 2010.   "
144822|NCT01388790|"     This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants     with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal     junction (GEJ) who have not previously received systemic chemotherapy for this setting.      All eligible participants will receive the combination of cetuximab plus S-1 (a combination     of tegafur, gimeracil, and oteracil) and cisplatin.   "
144828|NCT01388712|"     The most common cause of children chronic constipation is functional disorders. Functional     constipation is diagnosed after excluding organic causes of constipation (anatomical,     neurological, endocrinological) and identification of two symptoms defined by the Rome III     criteria. There could be low number of bowel movements (below three times a week), defecation     pain, fecal incontinence (once a week), stool consistency or occurrence of large diameter     stools. The treatment is change of diet, defecation training and application of laxatives.      The probiotics are defined as living microorganisms, which provided in a proper doses should     result in beneficial effect on a host health. The assessment of its characteristic is related     to strain of bacteria affiliation.      Taking into the consideration that patients with constipation may experience microflora     intestine disorders, using the probiotics can have the positive impact on process of treating     this disease. The additional reason for using the probiotics during the constipation     treatment is an influence of probiotics on movement of the alimentary canal.      In spite of proved effectiveness of some probiotics' strains further research are required,     because clinical significance is ambiguous and the effect is confirmed among patients with     short medical history. That's way the further analysis of probiotic Lactobacillus reuteri DSM     17938, which was successful treatment method of chronic constipation amongst children     (infants) should be performed.      The primary aim of the study is the assessment of Lactobacillus reuteri DSM 17938 efficacy,     provided with macrogol (Forlax), as treatment of constipation in 3-7 years old children. The     baseline of estimation is the frequency comparison of bowel movement in children belonging     into two groups: Lactobacillus reuteri treatment and placebo.      The secondary aim of the study is the assessment of frequency the additional symptoms     connected with defecation disorders: such as: number of pain episodes during defecation, the     intensity of pain, number of hard stools, number of fecal incontinence per week, number of     macrogol (Forlax) pockets used.      The investigators believe that constipation treatment (laxatives- macrogol) with     Lactobacillus reuteri has better efficacy that the same treatment without Lactobacillus     reuteri in 3-7 years old children with medical history of chronic constipation.   "
144829|NCT01388699|"     Recently, there is evidence that endothelial activation and dysfunction are associated with     migraine, especially in female migraineurs with aura. Our objectives were to determine     whether novel endothelial function markers are altered in female migraineurs with aura     compared to age-matched controls.   "
144830|NCT01388686|"     Structured web-based survey in selected hospitals with intensive care units in Berlin-     Brandenburg to collect data on the overall number of blood cultures (used) and the prevalence     of (positive blood cultures in patients with) CVC - associated sepsis.   "
144831|NCT01388673|"     The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument     indicated for endoluminal trans-oral tissue approximation and ligation in the     gastrointestinal tract. This study explores the specific application of tissue apposition in     dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass     (RYGB) pouch.      The primary objective of this study is to perform an evaluation of the safety of the ACE     Stapler for the treatment of dilated post-surgical gastric anatomy.      The secondary objective of this study is to evaluate the preliminary efficacy of the ACE     Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up     period.   "
144832|NCT01388660|"     This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to     investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg     of Aspirin and the simultaneous administration of the separate formulations of the two drugs     in healthy male volunteers.   "
144833|NCT01388647|"     This study will evaluate the safety and efficacy of eribulin in combination with carboplatin     and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor     receptor (HER)2 positive and are clinically stage IIA to IIIB.      The study regimen will be administered every 3 weeks for a total of 6 cycles followed by     definitive surgery.   "
144834|NCT01388634|"     The aim of the present study was to analyse factors associated with prolonged length of     hospital stay, readmission and death in a nationwide group of patients undergoing elective     ventral hernia repair in search for areas of interest to improve outcome after ventral hernia     surgery   "
144835|NCT01388621|"     The purpose of this trial is to estimate the therapeutic efficacy of the experimental     targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and     either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard     combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian     cancer. It is expected that the progression free survival rate at 12 months is improved by     the targeted regimen.   "
144836|NCT01388608|"     Data on activities of daily living in patients with rheumatoid arthritis are assessed mainly     be the health assessment questionnaire (HAQ). The HAQ generates data by subjective variables.     It would be desirable and advantageous to add objective tools reflecting patients' activities     to the outcome parameters in rheumatoid arthritis. The StepWatch™ activity monitor (SAM) in     an ankle worn step counter and an accurate instrument to measure real world ambulatory     activity. The investigators purpose was to investigate whether activities of daily living     measured by SAM increase during a therapy with the TNF-alpha inhibitor etanercept in patients     with active rheumatoid arthritis (RA).   "
144837|NCT01388595|"     Allergic rhinitis is an under diagnosed global health problem which affects up to 25% of the     population worldwide. It has been reported as being one of the 10 most common causes for     attendance to primary care clinics. It is clinically defined as a symptomatic disorder of the     nose induced by an IgE mediated inflammation following allergen exposure of the membranes     lining the nose and is characterized by varying combinations of nasal symptoms including     sneezing, nasal blockage, rhinorrhoea and itching. Intra nasal corticosteroids form the     cornerstone of anti-inflammatory therapy in allergic rhinitis and there is increasing     interest in the role of intranasal beta 2 agonists in the management of allergic rhinitis.     The question therefore arises as to whether salmeterol exhibits such synergistic activity in     the nose in terms of potentiating the steroid response of fluticasone.   "
144838|NCT01388582|"     The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl     estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or     Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant     growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly     assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or     identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS.     All women will be offered nonhormonal contraceptives prior to randomization. The pairs will     then be followed for four weeks. During this follow-up period, breast-milk intake will be     quantified by administering deuterium oxide to exclusively breast-feeding mothers and     measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known     as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric     measurements will be collected -- both as a value necessary to implement the breast-milk     quantification method, as well as an outcome for analysis, and a daily diary will be kept by     the women participating in the study that records infant feeds and diaper changes.   "
144840|NCT01388556|"     Exercise is often noted as an important component in a comprehensive approach to the     management of Parkinson disease (PD). Most studies of exercise have examined the effects of     short-term interventions and have tested participants on their anti-Parkinson medications. As     such, these studies have not been able to determine whether or not exercise may have a     disease-modifying effect in people with PD. The investigators recent work has shown the     potential benefits of dance as a form of exercise for individuals with PD, but, like previous     work, has only examined short-term interventions. The investigators think that dance may be     ideally suited for study over a longer period of time because dance incorporates many of the     features recommended for inclusion in PD-specific exercise programs in a format that is known     to be engaging and to enhance motivation to participate in healthful behaviors. As such, the     investigators aim to determine both the short- and long-term effectiveness of a     community-based dance program for individuals with Parkinson disease and to determine how     physical function changes over time in individuals with PD who do not exercise as compared to     those who exercise regularly. The investigators hypothesize that:      A) participation in dance will result in improved physical function, cognitive function, mood     and quality of life in people with PD within 3 months,      B) additional improvements will be noted at 6 months as compared to 3 months,      C) improvements will be maintained at one year with continued, regular participation in a     dance class,      D) those who do not exercise will show significant functional decline over a period of one     year, a decline that will not be present in those who dance regularly.   "
144841|NCT01388543|"     This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5     (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people     with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to     people with the normal metabolizing genotype.   "
144842|NCT01388530|"     This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and     feasibility of trigeminal nerve stimulation (TNS) as a treatment for     Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory,     pilot study will provide a basis for a federal grant application and larger controlled     trials.   "
144843|NCT01388517|"     Pityriasis alba (PA) is a frequent cause of consultation in tropical areas due to its chronic     course, trend to relapse and aesthetic impact. Currently, no treatment is widely accepted.     The objective is to assess the calcitriol and tacrolimus ointment efficacy in the treatment     of PA compared with petrolatum. Twenty lesions on the face greater than 3 cm, in individuals     of phototype IV-V, aged 3-18 years are going to be randomly assigned to receive petrolatum,     calcitriol, and tacrolimus twice daily. No photoprotection is going to be indicated, and     hygienic habits will not be modified. Patients will be evaluated at baseline and for 9 weeks,     by means of Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography     control.   "
144844|NCT01388504|"     The research question to be addressed is Does a 2.5 - 5 minute systemic intravenous     injection of sodium nitrite administered immediately before opening of the infarct related     artery result in significant reduction of ischaemia reperfusion injury in patients with first     acute ST elevation myocardial infarction (MI)?   "
144845|NCT01388491|"     This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive     compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy     women.   "
144846|NCT01388478|"     By doing this study, researchers will examine the safety and tolerability of R-pramipexole in     participants with Alzheimer's disease. This study will also examine the body and brain's     response to the study drug by measuring the amount of injury to the cells (oxidative stress)     in the blood and spinal fluid and brain imaging before and after treatment.   "
144847|NCT01388465|"     The investigators are testing the hypothesis that patients who are exposed to daily     text-message (TM) assessments with feedback will have better adherence to prescription than     those patients not exposed to TM-based queries with feedback.   "
144854|NCT01388374|"     The aim of this study is to explore whether the implementation of Nurse Practitioners can     lead to a more accessible and efficient patient care at the primary out of hours service.      The primary objectives of the proposed study are:        1. What are the effects of the implementation of NPs on the primary out of hours service in          comparison with the current out of hours service? Effects in terms of accessibility,          objective and subjective workload of general practitioners, quality of care and patient          satisfaction.        2. How efficient is the implementation of NPs in the primary out of hours services?        3. What is the feasibility of the implementation of NPs in the out of hours services? And          under which conditions?        4. What are the barriers and facilitating factors considering the implementation of NPs?   "
147630|NCT01351870|"     This is an international prospective randomised trial, which will compare two radiotherapy     regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully     staged 'standard risk' medulloblastoma.   "
144848|NCT01388452|"     Purpose: The purpose of this research study is to learn about two HIV tests - a clinical     presumptive diagnosis (PD) that a trained healthcare provider can quickly use to determine     if a child is likely to be HIV-infected and in need of HIV medicines and an expedited gold     standard RNA-PCR test (expedited PCR) that is done at the UNC Project lab located at the     hospital and the result given within 48 hours. Both of these tests can obtain results quickly     while the current test called dried blood spot DNA-PCR goes to a lab and the result may take     up to one month. The performance of PD and expedited PCR will be compared to one another with     respect to HIV-infected infants correctly initiating life-saving antiretroviral therapy.      Participants: Hospitalized children younger than 12 months of age who are HIV DNA-PCR     eligible at Kamuzu Central Hospital (KCH), in Lilongwe, Malawi. Other participants will be     patient caregivers and clinical officers who provide healthcare for children that could be     HIV-infected. Clinical officers will be trained to conduct the presumptive diagnosis test.      Procedures (methods): Patients will be randomized to either standard of care (PD and dried     blood spot DNA-PCR) or expedited PCR. A consultant pediatrician and a clinical officer will     perform the PD. If the PD or expedited PCR test results are positive, hospital care could     include HIV medicine.   "
144896|NCT01387828|"     The purpose of this study is compare two different surgical treatments of splenic artery     aneurysms: open and laparoscopic approach.   "
144849|NCT01388439|"     Oseltamivir dosing in infants < 3 months of age is based on a single pharmacokinetic study in     20 infants from a single center. This dataset is limited by a lack of robustness, because     only 1 sample was collected from each participant. The investigators obtained two blood     samples each from infants receiving oseltamivir after obtaining informed consent from the     infant's parents. The investigators propose to analyze the blood samples to determine the     amount of oseltamivir in the infant's blood. Measurement of these values will increase the     understanding of the absorption and elimination of oseltamivir in preterm and term infants,     and improve our ability to provide the correct doses to this high risk population.   "
144850|NCT01388426|"     Objective of this study is to evaluate the tolerance and potential benefit of moisture     chamber glasses for dry eye in an Asian population. In this clinic based prospective     interventional study, we aim to recruit patients (until 10 patients complete the study) who     have evaporative dry eye due to exposure to environmental stress (such as frequency of out     door activities) and keen to try out moisture chamber glasses/ eyewear from the dry eye     clinic in Singapore National Centre. After informed consent, these patients will be     prescribed 7eye( Panoptx)™ moisture chamber glasses/eyewear for 3 months and will be     monitored on a diary for the amount of time wearing eyewear for 2 weeks and the number of eye     drops for each type of medication used. Other outcomes will be changes in symptoms of dry eye     using visual analog scale, as well as objective signs of dry eye (eg. corneal fluorescence     staining and tear break up time (TBUT). As moisture chamber spectacles are currently not     available as a treatment option for dry eye in Singapore, the findings of this study will     give an insight to the efficacy of this new treatment modality in our population.   "
144851|NCT01388413|"     Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the     main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic     therapy increases the risk of multi-resistant bacterial infections, without reducing the rate     of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral Cyclic     Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and antibiotic Y on     odd weeks) seem to drastically reduce both the number of symptomatic UTIs and the number of     hospitalizations in patients with neurogenic bladder, without affecting bacterial ecology.      The objective of this study is to validate this preliminary work with a large-scale     randomized, parallel-group, multicenter study.   "
144852|NCT01388400|"     Stroke contributes significantly to the incidence of disabilities, with upper limb (UL) motor     impairment being especially prevalent. Animal studies suggest that post-stroke motor recovery     is largely attributable to adaptive plasticity in brain motor areas. While some environmental     training factors contributing to plastic mechanisms have been identified in animals,     translation of this knowledge to the clinical setting is insufficient. Optimal recovery may     be related to both external (e.g., feedback type) and internal factors (e.g., cognitive     ability, motivation). Clinically feasible methods for training are needed. Use of enriched     virtual environments (VEs) may provide a way to address these needs. Outcome measures that     best reflect recovery need to be identified since this is an essential step to evaluate the     effect of novel training programs for UL motor recovery in stroke.      The research question is which clinical and kinematic outcome measures best reflect motor     performance recovery after a targeted upper limb treatment intervention. Aim 1 is to compare     changes in outcome measures recorded before and after an upper limb intervention in stroke     subjects to motor performance in healthy subjects. Aim 2 is to determine motor performance     between-group differences sample size is based on knowledge of expected outcome measure mean     score differences between groups. Hypothesis. 1: Specific clinical and kinematic outcome     measures will be sensitive to within-group (pre-post intervention training) changes.     Hypothesis. 2: Specific clinical and kinematic outcome measures will be sensitive to     between-group (healthy vs. patients in enriched vs. conventional intervention groups. Sixteen     chronic stroke survivors and 8 age- and sex-matched healthy controls will participate.     Patients will be matched on cognitive and motor impairment levels and divided into two     groups. Using an single subject (A-B-A) research design, kinematics during two pre-tests, 3     weeks apart, will be recorded for test-retest reliability. Stroke groups will practice varied     upper limb reaching movements (15 45-minute sessions in 3 weeks) in environments providing     different motivation/feedback levels. Pre- and post motor performance evaluations will be     done with clinical tests and a Test Task with specific motor performance requirements. A     Transfer Task will also be recorded. By comparing data analysis methods (3-Dimensional (3D)     analysis of different markers or placements), the investigators will identify which kinematic     outcome measures best reflect motor improvement in post-test and follow-up sessions     (retention).      The expected results are identification of two primary and two secondary outcome measures     that reflect upper limb motor recovery and can distinguish between motor recovery and     compensation. The results will be used to design a randomized control trial to determine the     efficacy of VE-based treatment on arm motor recovery. The goal is to determine how extrinsic     (environmental) and intrinsic (personal) motivational factors affect motor learning in stroke     survivors with cognitive and physical impairment. Knowledge gained can also be used for     rehabilitation of other neurological and orthopedic pathologies.   "
144853|NCT01388387|"     The choice of an immunosuppressant after hepatic transplant is now more difficult than before     because of the increasing number of drugs available.      Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best     treatment and the best dose for each patient. The genetic polymorphism of enzymes     metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5     activity is a major determinant of the dose needed to reach target concentrations. This study     is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on     tacrolimus exposure in patients with hepatic transplant.   "
144855|NCT01388361|"     This trial is conducted in Europe and North America. The aim of this trial is to compare the     efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest     meal to insulin degludec in subjects with type 2 diabetes.      Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643     (NCT01193309) trial will be randomised to receive treatment intensification while subjects     with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to     receive insulin degludec treatment. Subjects are to continue their pre-trial metformin     treatment.   "
144856|NCT01388348|"     Current gold standard of bladder outlet diagnosis is pressure flow study. This study is     invasive time consuming and requires expensive and complex set-up. In this study the     investigators plan to evaluate an alternative technology that presumably is able to diagnose     bladder outlet obstruction using a Dynamic Urine Vibration Holter based on a Urine Flow     Vibration Analysis technology. The acoustic vibration sensor is a small device that records     the vibration due to urine flow. The patient attaches the sensor to the penis using a     disposable sensor patch for the duration of approximately one minute during one urination.     The analysis is performed off-line and the results are compared to the results of a standard     pressure flow study. The innovative technology for the diagnosis of bladder outlet     obstruction is noninvasive, rapid and does not involve complex setup.   "
144879|NCT01388049|"     To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection,     the investigators conduct a prospective clinical study. In comparison with results from     direct sequencing of Entervirus 71, the investigators evaluate the performance of e- Ab     sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The     potential factors which may interfere with the results would be investigated. With such     technique, the investigators hope to make early diagnosis and give EV71 patients early     treatment to reduce the complications and case-fatality rate.   "
144857|NCT01388335|"     The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein     (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in patients with solid     tumors or lymphomas. Information about any side effects that may occur will also be     collected. This is a drug interaction study so the treatment of the disease will not be the     main purpose of the study.      This is a Phase 1, open label, fixed sequence, 2 period study conducted in patients with     solid tumors or lymphomas. The duration of participation in this study will be up to     approximately 38 days not including screening, after which patients will be allowed to     continue receiving enzastaurin. There is no planned duration for the extension phase of this     study; patients will be allowed to continue to receive enzastaurin until fulfilling one of     the criteria for discontinuation, such as unacceptable toxicity or disease progression.   "
144858|NCT01388322|"     This is a Multicenter, randomized, open‐label, parallel groups study to test the hypothesis     that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks     of gestation could improve maternal and perinatal outcome in women at high risk for     developing placental‐mediated pregnancy complications.   "
144859|NCT01388309|"     This observational study will evaluate in clinical practice the change in Disease Activity     Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who     are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from     eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without     methotrexate) for 12 months.   "
144860|NCT01388296|"     the target of this study is to assess the minimum alveolar concentration of sevoflurane to     maintain theBispectral Index below 50.The minimum alveolar concentration (MAC) for     maintaining Bispectral Index below 50 (MACBIS50) of sevoflurane has been reported previously     in adult with Body Mass Index ( BMI) < 40 to be 0.97 and in enfant to be 2.83%, However,     there is no study assessed theBispectral Index below 50 (MACBIS50 ) in morbidly obese patient     (BMI > 40). The first aim of our study is to assess the MACBIS50 of sevoflurane in morbidly     obese patients BMI 40 - 70 using the Continuous Reassessment Method (CRM) in 80 % of     patients.   "
144861|NCT01388283|"     The purpose of this study is to assess the predictive role of serum inflammatory markers in     pregnant women who subsequently develop preeclampsia.   "
144862|NCT01388270|"     The purpose of this study is to determine whether the heparin-coated dialysis filter is     superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis     (HD) patients.      The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional     filter will be compared by means of statistical tests.   "
144863|NCT01388257|"     The purpose of this study is to demonstrate, in patients treated with adalimumab, the     efficacy of proctological surgery in anoperineal fistula healing after the removal of seton     drain.   "
144864|NCT01388244|"     The Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE) is a randomised     population-based study, including 20,904 Danish women aged 65-81 years, investigating the     effectiveness of a two-step screening programme for osteoporosis, using a questionnaire based     on FRAX® followed by DXA-scan of those at highest risk. Further, the study is expected to     provide knowledge about cost-effectiveness, patient preferences and acceptance of screening     programme to prevent fractures   "
144865|NCT01388231|"     The study aims at examining the effects of additional training in manualized     cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The     investigators will investigate how CBT, specifically the treatment procedures and manuals     proposed by Clark and Wells (1995), can be transferred from controlled trials into the less     structured setting of routine clinical care, and whether the health care system benefits from     such developments. Private practitioners (N=36) will be randomized to one of two treatment     conditions (i.e., training in manualized CBT vs. treatment as usual without specific     training). The investigators plan to enroll 160 patients (80 per condition) to be able to     detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25%     (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and     more widespread dissemination of effective interventions. The following research questions     can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient     care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3)     Will treatment effects in routine psychotherapeutic treatments be comparable to those of the     controlled, strictly manualized treatment of the main study?   "
144866|NCT01388218|"     The purpose of the protocol is to develop final draft PRO instruments of physical activity in     daily life to be used and evaluated in the further validation studies measuring physical     activity in chronic obstructive pulmonary disease (COPD) patients.   "
144878|NCT01388062|"     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor     for influenza virus detection, the investigators conduct a prospective clinical study. In     comparison with results from direct sequencing of influenza virus, the investigators evaluate     the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and     cross-reaction. The potential factors which may interfere with the results would be     investigated. With such technique, the investigators hope to make early diagnosis and give     influenza virus patients early treatment to reduce the complications and case-fatality rate.   "
145026|NCT01386099|"     The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of     PSN821 in patients with type 2 diabetes.      Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the     start of treatment and at the end of a 12 week treatment period as the primary endpoint.     HbA1c, fasting plasma glucose and body weight are secondary endpoints.   "
144880|NCT01388036|"     Beta 1 Adrenergic antagonists (beta blockers) have major role in the treatment of CHF, IHD     and hypertension. However, there is large interindividual variability in the response to beta     blockers.      The hypothesis underlying this study is that genetic differences between individuals will     determine the individual response to esmolol, a betablocker that is administered     intravenously. Esmolol will be administered intravenously to healthy volunteers, and the     effects on heart rate and blood pressure will be monitored. In addition, we will measure     plasma renin activity and plasma levels of norepinephrine.   "
144867|NCT01388205|"     This study aims to implement a new family-based health behavior community program to increase     time spent outdoors and physical activity among Singapore children aged 6 to 12 years in a     1-year randomized clinical trial. 300 children from 250 families will be randomly assigned to     either a family-based intervention or no intervention. The family-based intervention     comprises structured weekend outdoor activities organized by National Parks and incentives     for children to wear a pedometer and increase their daily steps. Families who meet their     monthly step and outdoor activity goals will receive a range of prizes and incentives. Both     groups will receive brochures on the National Myopia Prevention Program and physical     activity. The success of the intervention will be evaluated through light meters, 7-day     outdoor diaries, questionnaires documenting outdoor time and myopia; as well as pedometer     steps, walking tests, and body mass index. A community-based intervention will be developed     to improve the health of Singapore children by increasing outdoor time and physical activity     to prevent myopia and obesity.   "
144868|NCT01388192|"     Pancreaticoduodenectomy (PD) involves removing the head of pancreas, duodenum, common bile     duct, gall bladder, and/or distal stomach. In general, the postoperative changes are thought     to be moderately severe, and about 20% of these patients go on to develop new clinical     diabetes. PD-related factors of glucose metabolism will include removal of half of the     pancreatic endocrine tissue, exclusion of the proximal small intestine, postoperative weight     loss (on average, ~8% of body weight), and removal of putative diabetogenic factor in     resected neoplasm. However, effect of removal of duodenum on glucose metabolism after PD has     never been studied. The investigators plan to examine this issue by comparing fasting plasma     levels of insulin, fasting plasma glucose, C-peptide, HbA1C, HOMA-insulin resistance, GLP-1     response after a standard meal, and body mass index (BMI) of patients before and after PD.   "
144869|NCT01388179|"     Autism is a developmental disorder characterized by abnormalities in speech and     communication, impaired social functioning, and repetitive behaviors and interests. The term     Autism spectrum disorders or ASD is often used to include autistic disorder, Asperger     syndrome and pervasive developmental disorder-not otherwise specified (PDD-NOS).     Epidemiological research suggests that ASDs affect at least 60 per 10,000 youth, with     estimates as high as 120 per 10,000.      Severity of autistic features is not easily defined and the use of different diagnostic tools     compounds the ability to lay a clear cut definition. It is, though, generally accepted that     children with autism and normal IQ (>70) are high functioning regardless of the severity of     their autistic features. The investigators will use the terms autism and ASD     interchangeably, and the term low functioning autism will be used to describe those     children with autism who have, or are presumed to have, IQ<70.      The pathophysiology of autism has been studied extensively in the last decade. Abnormal     neuronal connectivity has been implicated in a growing body of research. In addition, areas     of over and/or under neuronal activation have been detected on functional MRI(Magnetic     Resonance Imaging).      Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive technique that allows to     affect brain activity. The pulses are administered by passing high currents through an     electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric     field in the underlying brain tissue. When the induced field is above a certain threshold,     and is directed in an appropriate orientation relative to the brain's neuronal pathways,     localized axonal depolarizations are produced, thus activating the neurons in the relevant     brain structure.      rTMS has been studied in individuals with high functioning autism. rTMS treatment was found     to have an electrophysiological effect and to reduce repetitive behaviors and improved social     functioning.      In the context of existing pilot data suggesting effect of rTMS treatment in individuals with     high functioning autism, the investigators propose a pilot study to assess the efficacy of     rTMS in children and adolescents with low functioning autism.   "
144870|NCT01388166|"     The objective of this observational study is to collect and evaluate data on medication     adherence of patients on maintenance COPD therapy with long-acting anticholinergic (e.g.     Spiriva® delivered by HandiHaler® or Respimat®) using the MMAS-8 questionnaire.   "
144871|NCT01388153|"     To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken     without or with water and the Glucobay standard tablet taken with water   "
144872|NCT01388140|"     The goal of the project is to investigate the prevalence of dissociative disorders in     psychiatric inpatients in Taiwan. Relevant clinical issues, including common psychiatric     comorbidity (e.g., positive psychotic symptoms), associated psychosocial factors (e.g.,     negative life events, perceived parenting style), and neuro-cognitive underpinning (e.g.,     executive functions) were also targeted. Standardized interview schedules, self-report     scales, and cognitive tasks will be applied. The investigators hypothesized that dissociative     disorders would be associated with positive psychotic symptoms, a history of early     interpersonal adversity, and enhanced executive functions.   "
144873|NCT01388127|"     The investigators will perform a double blind controlled study to investigate the efficacy of     oral administration of 200 mg minocycline, on the neurological and functional outcome after     acute hemorrhagic stroke and the effect on blood brain barrier permeability.   "
144874|NCT01388114|"     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor     for serum PCT level measurement will offer a test with lower cost, and increase the     applicability of serum Procalcitonin (PCT) level in daily clinical practice.   "
144875|NCT01388101|"     To develop a real-time diagnostic technique with e- Ab sensor for specific LECT2 detection in     clinical specimens of Hepatocellular carcinoma (HCC) patients, the investigators conduct a     prospective clinical study. In comparison with results from direct sequencing of LECT2, the     investigators evaluate the performance of e- Ab sensor, including reproducibility,     sensitivity, specificity, and cross-reaction. With such technique, the investigators can     obtain LECT2 information of HCC patients in cost-saving and time-saving way and can offer     more individualized treatment for our patients.   "
144876|NCT01388088|"     The investigators wish to investigate the potential effects of potassium. In this study we     will examine patients with hypertension and increase their potassium-levels using Amiloride     and Spironolactone.      The investigators will examine the changes in the cardiovascular system using a     Sphygmocor-scanner.   "
144877|NCT01388075|"     The genetic factors associated with variability in CYP2C9 induction have not been elucidated.     The hypothesis underlying this study is that following 7 days treatment with rifampicin, a     known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9     expression will be associated with the magnitude of change in INR response to warfarin and in     CYP2C9-mediated warfarin metabolism.   "
144892|NCT01387880|"     This is an open, multicenter phase II trial of therapy with a combination of cetuximab, and     irinotecan every second week combined with a daily dose of everolimus to patients with     metastatic colorectal cancer with Kirsten rat sarcoma viral oncogene (KRAS) mutation or to     patients resistent to cetuximab and irinotecan therapy for metastatic colorectal cancer.   "
144883|NCT01387997|"     To develop a real-time diagnostic technique with e- Ab sensor for high risk human papilloma     viruses(high risk HPV) detection, the investigators conduct a prospective clinical study. In     comparison with results from direct sequencing of HPV, the investigators evaluate the     performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and     cross-reaction (such as detection of low risk HPV). The potential factors which may interfere     with the results would be investigated. With such a real-time diagnostic technique, the     investigators hope to obtain information of patients in cost-saving and time-saving way and     can give patients early treatment and offer more individualized treatment for our patients.   "
144884|NCT01387984|"     In this study, the investigators plan to establish the relationship between plasma     concentration of YKL-40 with various vascular complications in the patients of type 2     diabetes.   "
144885|NCT01387971|"     Currently, due to the advantage of noninvasive, localized, rapid, painless and easily     repeatable of impression specimens, the technique is an ideal method of investigating ocular     surface disorders when the diagnosis is not clinically obvious or detecting the     post-operative change without tissue damage. Using impression cytology for primary diagnosis     and follow-up of ocular surface squamous neoplasia, including after therapy with topical     mitomycin C has been well-studied. [29]. In addition to the applications described above,     pterygium is another disease of interest. Pterygium, a common disease of ocular surface, has     high recurrence rate after surgical excision. [30-33] However, the exact etiology and     mechanism for recurrence is unknown. A transformation of the phenotypic characteristics of     the conjunctival fibroblasts may play an important role. Due to the concern of improvement in     treatment, it is important to explore the change of cytomorphology after pterygium operation,     to identify the risk factors of developing recurrence, and, furthermore, to clarify the     etiology and mechanism. Some ophthalmologists may think this procedure too time-consuming to     be a routine examination in outpatient clinics. [34] However, National Taiwan University     Hospital (NTUH), as one of the largest tertiary medical centers in Taiwan, is now in charge     of a big part of difficult cases of ocular surface. With the need of further precise     diagnosis and delicate clinical skills, the investigators are competent for this meaningful     program.   "
144886|NCT01387958|"     This is a proof of concept study, designed to look at the safety and antiviral activity of     LCQ908 in hepatitis C infected patients.   "
144887|NCT01387945|"     This intervention study will evaluate the feasibility,acceptability and effectiveness of an     e-health enabled model of care by randomly assigning a trained patient navigator and/or a     blood pressure (BP) self-management web portal to patients with uncontrolled hypertension     after a run in period with a home BP monitor (HBPM) and comparing the results on blood     pressure control. We anticipate that patients receiving the combination of a patient     navigator(PN)with a self-management web portal and home BP monitor will have better BP     control than when the only received a home BP monitor.   "
144888|NCT01387932|"     The purpose of this study is to evaluate overall survival in patients treated with     HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with     particle PVA.   "
144889|NCT01387919|"     Several studies have begun to determine the time course of events sensing energy availability     in rodents. In contrast, there is not a single study that has examined this in humans to     date. A better understanding of this energy sensing machinery in humans is of utmost     importance to give us new insights into developing new therapies for common diseases such as     obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases,     disturbances in the energy-sensing machinery possibly play a role. To determine the time     course of energy sensing events in humans, the investigators will measure the concentration     of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time     points during starvation in humans. The investigators choose to study the molecular machinery     in muscle, since muscle is very sensitive to fuel deprivation.   "
144890|NCT01387906|"     The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost     .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is     a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the     Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will     be day 270 period.   "
144891|NCT01387893|"     The objective of this study was to evaluate the effectiveness of the Digital Repetitive     Infrapubic Pressure maneuver, a self-administered procedure used to provide symptomatic     relief in initiating and maintaining urine flow impeded by benign prostatic hyperplasia.   "
147631|NCT01351857|"     Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D)     improves diabetes clinic attendance as well as glycemic control after transition from     pediatric to adult diabetes care.   "
144893|NCT01387867|"     According to Danish and international guidelines the recommended first-line of management for     people with osteoarthritis consist of exercise, education, analgesic medication, and, if     necessary, weight reduction. It is well documented that exercise has a positive effect on     pain and physical function in patients with knee OA, but the effect of exercise on hip OA is     sparsely investigated.      Aim of the study: To investigate the effects of 1) strength training, and 2) Nordic Walking,     and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical     activity, and health related quality of life in patients with osteoarthritis of the hip.      The effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e.,     disease activity, inflammation, and cartilage degradation, are investigated in a subgroup     (n=45) of the participants.      Study hypotheses: Strength training will have a greater effect on physical function and     muscle strength than Nordic Walking and home based exercise; 2) Nordic Walking will have a     greater effect on endurance than strength training and unsupervised home based exercise; 3)     Strength training and Nordic Walking will have a greater effect on pain level and health     related quality of life than unsupervised home based exercise.   "
144894|NCT01387854|"     There is limited information on the long-term effects of treating patients with MPS VI with     Naglazyme® and limited data on the natural history of treated and untreated MPS VI patients.     The Re-survey Study ASB-00-03 will assist in understanding the effects of long-term Naglazyme     treatment and the natural history of the MPS VI patient population.   "
144900|NCT01387776|"     This is a study for the evaluation of the benefits of 1 st Trimester risk markers in     detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a     potential marker for Trisomy 21 and other aneuploidies.      Aim of this prospective nonprofit study is to analyze the benefits of early onset pre     eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood     pressure and Doppler ultrasound), and how the results can permit to modify or influence the     course of the preeclampsia during the pregnancy. The investigators will also evaluate the     potential use of the PIGF as a marker to improve the prenatal screening with the currently     used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta     subunit of human chorionic gonadotropin (fBhCG) parameters.   "
144901|NCT01387763|"     The purpose of the study is to compare the efficacy and toxicity including quality of life of     two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea     (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant     interferon.   "
144902|NCT01387750|"     A single center trial to evaluate the efficacy, tolerance, and acceptability of Oxygenated     Glycerol Triesters (OGT) mentholated cream on acute musculoskeletal pain in normal healthy     adult volunteers suffering from a recent inflammation of muscles and joints. Patient who met     eligibility requirements were instructed to identify one area on their body where they were     experiencing the most acute musculoskeletal pain/discomfort. Patients were provided with     visual analog scales in order to quantify their pain. Patients either received mentholated     cream with or without OGT and instructed to rub on the identified site 3 times a day for 7     days. Pain and other observations were written in a diary for each day.   "
144903|NCT01387737|"     The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or     combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type     2 diabetes mellitus on 52 weeks oral administration.   "
144904|NCT01387724|"     RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory     may help doctors learn more about changes that occur in DNA and identify biomarkers related     to cancer.      PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients     with newly diagnosed neuroblastoma.   "
144905|NCT01387711|"     This trial will be conducted to explore the biological effects in the skin following     treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by     histology.   "
144906|NCT01387698|"     The primary objective of this study is to confirm the long-term efficacy (remission and     maintenance in remission) of current validated treatments. Each patient will be followed     during 3 years in this non-interventional trial.   "
144907|NCT01387685|"     Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The     investigators will compare data from the chart, telephone interviews and physical     examinations between those who underwent mesh placement to those who underwent placement of     PIVS.   "
144944|NCT01387191|"     The objective of this study is to evaluate the incidence of adverse events in Japanese     pulmonary arterial hypertension subjects treated with epoprostenol injection based on     prescribing information under the conditions of general clinical practice and also to grasp     the following items;        1. Unknown adverse reactions (especially, significant adverse reactions)        2. Adverse reaction onset status under practical drug use conditions        3. Factors possibly influential on safety        4. Factors possibly influential on efficacy        5. Patient's prognosis, efficacy and safety in long-term use   "
144908|NCT01387672|"     Purpose: NABT: To compare five widely available nitrate formulations: (1) 15 of nitroglycerin     (NTG) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual NTG, (4) 20 mg of isosorbide     mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch), for their     efficacy on markers of bone formation and resorption and for the incidence and severity of     headache they cause.      Hypothesis: There is one ideal nitrate preparation which balances the clinical efficacy in     bone remodeling against the common side effect of headache.      NABT-B: To determine if nitrates affect markers of bone formation (serum BALP and P1NP) and     resorption (serum CTX and urine NTX) in women who have recently discontinued treatment with     alendronate, risedronate or zoledronate.   "
144909|NCT01387659|"     This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in     diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant     recipient population, our study will determine any different responses, including     autoimmunity, between Hispanic, and Caucasian, patients.   "
144910|NCT01387646|"     The purpose of this Stage II clinical trial is to test the efficacy of a culturally     sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority     adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy     and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging     contraceptive use. Its primary goal is to expand risk-reduction interventions created in     previous studies to further increase intervention efficacy for this particularly vulnerable,     high-risk group. An adolescent intervention has been created and pilot tested in     developmental studies. Results indicated reductions in substance use, risk behaviors,     unintended pregnancy, STI and abuse without reports of adverse outcomes. Specific aims of the     current study include: 1) To obtain a more in-depth understanding of configurations of     psychosocial and situational factors associated with high-risk sexual behavior, substance     use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To     implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention     consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this     group; 3) To evaluate the effects of the adolescent intervention model versus enhanced     counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk     sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and     STI/HIV at 6 and 12 months follow-up. Participants will include a convenience sample of 600     Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or     physical abuse and current STI.   "
144911|NCT01387633|"     The purpose of this study is to evaluate the impact of an educational program for people with     diabetes mellitus based on the family social support.   "
144915|NCT01387581|"     The objective of this study is to determine and compare the performance of dermatologists (in     Germany) on the excision decision against the performance of MelaFind, a non-invasive and     objective multi-spectral computer vision system designed as a tool to aid dermatologists in     the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to     the average excisions sensitivity of dermatologists.      Another objective is to determine and compare the performance of dermatologists (in Germany)     with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity     of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of     dermatologists without the aid of MelaFind.      A similar study was previously conducted with dermatologists in the US (NCT01011153). An     exploratory objective is to compare the excision decisions of dermatologists from the     previous study (in the US) to dermatologists in in this study (in Germany).   "
144916|NCT01387568|"     In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine     in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and     hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten     return of bowel function.   "
144917|NCT01387555|"     This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more     effective in improving survival than best supportive care in patients with advanced     Hepatocellular Carcinoma (HCC) who have failed sorafenib.   "
144918|NCT01387542|"     The purpose of this study is to evaluate the effectiveness and safety of paliperidone     extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of     emotional instability, detachment from reality, often with delusions and hallucinations, and     withdrawal into the self) participants.   "
144919|NCT01387529|"     The objective of this study is to establish reference values for non-invasive hydration     status markers. Although there are no hypotheses associated with this study, the outcome will     help advance the development of non-invasive hydration status monitors (described above and     in H08-12; A-15208) capable of detecting dehydration from a single, static measure. The     outcome that this research effort supports what is recognized by the military community as a     high priority medical technology gap (MOM ICD v1.3, 2008).   "
144992|NCT01386567|"     The purpose of this study is to determine the continued effects of Androxal on morning     testosterone and reproductive status in men with secondary hypogonadism who have completed     protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim     (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5     mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the     lower dose.   "
145051|NCT01385774|"     The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of     two treatment strategies of Intermittent Claudication (IC) due to an iliac artery     obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous     Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.      It is our hypothesis that PTA as first line treatment is more effective than SET as first     line treatment with regard to maximum walking distance, quality of life and costs after one     year.   "
144920|NCT01387516|"     The long-term objective of this research is to increase the investigators understanding of     effective smoking interventions for understudied adolescents at high risk for continued     smoking into adulthood.      This randomized clinical trial uses a 2 x 2 between groups design to investigate Motivational     Interviewing (MI) versus Relaxation Therapy (RT), and Cognitive Behavior Therapy (CBT) versus     Self-Help Programming (SHP). Treatments are provided during brief stay in detention and     adolescents are followed after release. The investigators seek to increase quit rates     post-release, and the investigators will examine the moderating and mediating effects of     motivation, anger, and self-efficacy. The investigators will study main effects for treatment     as well as whether the combination of MI/CBT is more effective than other treatments in     enhancing quit rates.      Frequently, treatment for smoking cessation is unavailable to youths in the juvenile justice     system, and when treatment is available, it may be provided using untested therapies. This     study extends previous research by rigorously evaluating smoking cessation interventions     specifically for teens at highest risk for continued smoking in adulthood. The investigators     will examine processes contributing to the efficacy of treatments. The development of     effective smoking interventions for juvenile detainees has the potential to reduce a     significant public health concern in this undeserved and high-risk population.   "
144921|NCT01387503|"     This clinical trial is aimed at extending the chance of liver transplantation, through     downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding     conventional Milan Criteria.      Those patients that will achieve a sustained tumor response after downstaging will be     randomized either to undergo liver transplantation or to proceed with conventional     non-transplant treatments.      The aim of the study is to demonstrate unequivocally that liver transplantation may provide a     survival benefit, with an acceptable survival rate of at least 60% at 5 years, to patients     that demonstrate a radiological and sustained tumor response after downstaging. Noteworthy is     that response is chosen rather than stage migration as endpoint of downstaging.   "
144922|NCT01387490|"     This study compares the effects of Individualized Scheduled Telephone Support (ISTS) and     Usual Care (UC) for service members with Mild Traumatic Brain Injury (mTBI). A total of 400     service members will participate in this study. ISTS is a telephone intervention that     provides injury-related education, training in problem solving, and focused behavioral     strategies for problems (e.g. anxiety, depression) that commonly co-occur with MTBI. ISTS     also includes access to usual care and web-based and printed educational material. The 12     phone calls included in ISTS will be administered over a 6-month period. UC is the usual care     provided to service members attending the Traumatic Brain Injury (TBI) Clinics at Madigan     Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings     of educational materials over a 6-month period. Subjects will complete major assessments at     study entry and then 6 months and 12 months later. The primary aim of the study is to compare     the effects of ISTS and UC on post-concussive symptoms and emotional distress at the 6-month     assessment. The investigators predict that participants who receive ISTS will report lower     levels of post-concussive symptoms and emotional distress at the 6-month assessment.     Secondary aims include comparing the longer term effects of ISTS and UC at the 12-month     assessment, as well as comparing their effects on other outcomes such as post-traumatic     stress symptoms, quality of life, resilience, and work activity.   "
144923|NCT01387477|"     Tight glucose control in intensive care has become a major concern, allowing a reduction in     morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which     can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG     and measures of brain electrical activity noninvasively. It has already been shown that its     value changes according to hypoglycemia and its correction. Furthermore, if the hormonal     response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case     in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of     glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a     substrate for gluconeogenesis and an energy substrate during critical situations. It has been     shown to improve neurological tests during hypoglycaemia and had cerebral protective     properties after a severe head injury. The hypothesis of this study is that sodium lactate is     superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic     variation, brain function and hormonal response.   "
144924|NCT01387464|"     The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium     in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to     routine cataract surgery.   "
144925|NCT01387451|"     Retrospective studies have combined positron-emission tomography and computed tomography     (PET-CT) to identify adipose tissue with a high rate of uptake of     18F-fluorodeoxyglucose(18F-FDG) as active brown adipose tissue(BAT). In addition, biopsy     specimens and immunohistochemical staining with a UCP1-specific antiserum were used to     indicate that normal adults were able to have BAT. However,these studies only chose few     subjects and limited to the neck tissue. Therefore, the investigators intend to test BAT in     different parts of adults and analyse the clinical factors.   "
144926|NCT01387438|"     Previous studies have shown that active brown adipose tissue (BAT) is present in adults and     may play important roles in material and energy metabolism. However, most of these studies     were tumor-based populations and retrospective study. Due to the large amount in our cohort,     the investigators are able to promote a cross-sectional study of the incidence and factors of     BAT in adult chinese. In addition, the investigators can analyse the metabolic profiles in     healthy adults with active BAT.   "
144993|NCT01386554|"     The purpose of this study is to provide nephrologists with additional clinical evidence     regarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathic     membranous nephropathy. Approximately sixty (60) subjects will be randomized in this     double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and     Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week     observation period. The primary objective of this study is to assess the proportion of     treatment-resistant subjects (defined as subjects who either have had no response or have     suffered a relapse after achieving a partial response to their most recent standard treatment     regimen) who have a complete or partial remission of proteinuria in nephrotic syndrome due to     idiopathic membranous nephropathy after 24 weeks of treatment.   "
144927|NCT01387425|"     Objectives      This protocol is intended to provide information regarding the efficacy and safety of the     nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking     cessation in diabetic subjects who smoke. Given that a better understanding of predictors of     smoking cessation can be useful in identifying potential quitters and likely relapsers and     that little is known about these predictors in diabetics, the role of different predictors of     abstinence at the end of the study will also be examined Study Population The study will     enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and     motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design     The study is a double-blind, placebo-controlled, randomized clinical trial designed to assess     the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking     cessation. The duration of active treatment will be 12 weeks and subjects will be followed in     the nontreatment phase for an additional 12 weeks. This clinical study has an optional     research component to prolong the follow up in the nontreatment phase for a full year.     Predictors of abstinence at the end of the study will also be examined Study Endpoints     Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success rates     will be defined as the Continuous Quit Rate since last visit. Subjects will be classified as     responders if they are able to maintain abstinence from cigarette smoking during this period     of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained     through reports of cigarette use by means of the Nicotine Use Inventory confirmed by a     measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on     the study visit at week 24 Co-primary endpoint: Success rates at week 12 in the varenicline     vs placebo group. Success rates will be defined as Continuous Quit Rate for Weeks 8 to 12 of     treatment. Subjects will be classified as responders if they are able to maintain complete     abstinence from cigarette smoking in each of the last four study visits (week 9, week 10,     week 11, and week 12) with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will     be obtained through reports of cigarette use by means of the Nicotine Use Inventory during     the last four study visits (week 9, week 10, week 11, and week 12) confirmed by a measurement     of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study     visit Secondary Endpoint: Success rates at week 52 in the varenicline vs placebo group.     Success rates will be defined as the Continuous Quit Rate throughout the last three visits     (week 24, week 36, and week 44). Subjects will be classified as responders if they are able     to maintain abstinence from cigarette smoking during this period of time with end-expiratory     exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette     use by means of the Nicotine Use Inventory during the last three study visits (week 24, week     36 and week 44) confirmed by a measurement of an end-expiratory exhaled carbon monoxide     concentration that is ≤ 10 ppm on each study visit Additional Measures: Given that a better     understanding of predictors of smoking cessation can be useful in identifying potential     quitters and likely relapsers and that little is known about these predictors in diabetics,     the role of different predictors of abstinence at week 24 and at week 52 will also be     examined   "
144928|NCT01387412|"     The primary objective of this study is to determine the role of genital warts (GW) on Human     Immunodeficiency Virus (HIV) acquisition among men who have sex with men (MSM) in Peru. The     secondary objectives are to determine Human Papillomavirus (HPV) prevalence in HIV positive     MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM.   "
144929|NCT01387399|"     The purpose of this phase I study is to determine the safety, feasibility, maximum tolerated     dose (MTD), pharmacokinetics and pharmacodynamics of Cisplatin administered as Intraoperative     Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients with Platinum-Sensitive     Recurrent Ovarian Cancer.   "
144930|NCT01387373|"     This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second     week in combination with systemic capecitabine and in patients with a HER2-positive tumour in     combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases     from breast cancer.      Only patients without extrahepatic disease are included.   "
144931|NCT01387360|"     This clinical study has been planned to determine the effectiveness of a special laser     treatment intended to correct both near and distance vision in patients who have undergone     previous cataract surgery.   "
144932|NCT01387347|"     Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide     that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal,     ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that     Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259     (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product     that meets a major unmet medical need in patients with dry eye.   "
144933|NCT01387334|"     Resistance exercise is effective in improving glycemic control in diabetes patients. The     effectiveness of a home-based resistance exercise program has not been establish.   "
145667|NCT01377701|"     Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to     damage of vision. This study aims to evaluate the predictive factors for recovery of vision     in patients with pituitary adenomas following trans-sphenoidal surgery.   "
144934|NCT01387321|"     In this study, BYL719 will be administered to adult patients with advanced solid tumors whose     disease has progressed despite standard therapy or for whom no standard therapy exists. The     trial will investigate the safety and tolerability and determine the MTD of BYL719 in     Japanese patients.   "
144935|NCT01387308|"     Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.   "
144936|NCT01387295|"     This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second     week in combination with systemic capecitabine and in patients with a HER2-positive tumour in     combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases     from breast cancer.      Only patients with limited extrahepatic disease are included.   "
144937|NCT01387282|"     The administration of Anamorelin in patients with Stage III-IV non-small cell lung     cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and     muscle strength.   "
144938|NCT01387269|"     The administration of Anamorelin in patients with Stage III-IV non-small cell lung     cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and     muscle strength.   "
144939|NCT01387256|"     This double blinded, placebo-controlled randomized trial will compare the safety, efficacy     and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period     (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of     mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800     mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the     participant.   "
144940|NCT01387243|"     To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing     to lose weight.   "
144941|NCT01387230|"     The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation     Powder is safe and effective compared with placebo or no active drug intake, when     administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).   "
144942|NCT01387217|"     This protocol describes the first administration of GSK2018682 to humans. The study will     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending     doses of GSK2018682. The study will also provide preliminary evidence of the potential     therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte     counts.   "
144943|NCT01387204|"     GSK1120212 is a reversible and highly selective allosteric inhibitor of MEK1 and MEK2     activation and kinase activity currently being developed for the treatment of malignant     melanoma. This is a Phase I, open-label, non-randomized, single-dose study designed to     characterize the absorption, distribution, metabolism, and elimination (ADME) of a single     oral dose of MEK inhibitor [14C]GSK1120212 as a solution in male subjects with solid tumor     malignancies. A sufficient number of subjects will be enrolled to complete approximately four     evaluable subjects. Following completion of the study, subjects may elect to continue dosing     with GSK1120212 in the rollover study, MEK114375.   "
145052|NCT01385761|"     The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the     current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.   "
144945|NCT01387178|"     Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation     caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in COPD     appears to be irreversible, evidence suggests that the course of COPD can be altered through     measures such as smoking cessation, pulmonary rehabilitation, and the use of pharmacotherapy     for bronchodilation. A primary goal of maintenance pharmacotherapy is to reduce the incidence     of acute exacerbations and the associated hospitalizations and emergency department (ED)     visits. Bronchodilation in COPD maintenance therapy can be accomplished with the long-acting     anticholinergic tiotropium (TIO), long acting beta-agonists (e.g. formoterol, salmeterol),     methylxanthines (e.g. theophylline), or combination therapy with a long-acting beta-agonist     and an inhaled corticosteroid (e.g. fluticasone propionate/salmeterol [FSC]).      The objective of this study is to compare the benefits of combination long-acting     beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The study     compares the risk of COPD exacerbations and COPD-related healthcare utilization and costs for     commercially-insured patients age 40 and older who were prescribed FSC to those prescribed     TIO. The null hypothesis is that no difference exists between the costs and outcomes of COPD     patients treated with TIO and those treated with FSC. The test hypothesis is that patients     treated with either TIO or FSC will incur lower costs and use fewer healthcare resources for     the management of COPD.      The source of data for this study was the Ingenix Impact database (formerly the Integrated     Healthcare Information Services [IHCIS] database). This is an administrative claims database     that includes patient-level data on enrollment, facility, professional, and pharmacy services     from approximately 50 million patients covered by more than 40 managed care health plans     across the United States (US).      The study design is a retrospective cohort study.   "
144946|NCT01387165|"     The DEAL (Diabetes En America Latina) study was a multicenter, cross-sectional,     epidemiological, questionnaire based study carried out between October 2004 and October 2005     in 9 Latin American countries.   "
144947|NCT01387152|"     Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a     nuclear isotope during a stress on the heart that permits taking pictures of the heart     muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of     the nuclear isotope than standard protocols, by utilizing a new, more efficient camera     (called an Alcyone camera) which could decrease radiation dose to patients while still     providing excellent clinical information. Subjects will undergo imaging under the Alcyone     camera after undergoing stress testing with exercise or a standard medication simulating     exercise, and then at rest if needed. Subjects will have follow-up to measure events     occurring after the test, such as death, heart attack, unstable angina, repeat emergency     department visit for chest pain evaluation, or repeat imaging needed to evaluation for     coronary artery disease. Radiation doses and quality of the images from the imaging with the     new protocol will be recorded to compare to those used in standard nuclear imaging protocols.     The primary study hypothesis is that greater than 90% of patients who have a normal very low     dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3 months after     study of death, nonfatal myocardial infarction, unstable angina, and repeat emergency     department visit for chest pain evaluation or repeat anatomical or functional cardiac     imaging.   "
144948|NCT01387139|"     The purpose of this study is to compare the effectiveness of the co-administration of     intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural     sedation in the pediatric emergency department. The investigators hypothesize that patients     receiving co-administration of ketamine and propofol will have a lower rate of adverse     events, compared to patients receiving ketamine for procedural sedation.   "
144949|NCT01387126|"     The aim of this study is to investigate whether the supplementation of a medically supervised     weight management program with a novel fibre supplement, improves body weight, body     composition, and laboratory measurements in overweight and obese individuals. All subjects     will participate in the medical weight management program however the intervention group will     have 5 grams of a novel fibre supplemented to each meal while the control group will not.   "
144950|NCT01387113|"     This is an open label single center phase II trial, evaluating the utility of 64 slice CT     perfusion (CTP) in acute ischemic stroke (AIS) patients. The main aim is to determine which     aspects of CTP imaging can aid in expanding the time window for thrombolysis with IV (rt-PA)     in AIS patients up to 6 hours after symptom onset.   "
144951|NCT01387100|"     The purpose of this study is to explore the effects of a brief vocational rehabilitation     intervention on individuals with arthritis who are concerned about their ability to remain     employed.   "
144952|NCT01387087|"     The objective of the study is to explore safety and tolerability of single ascending doses of     ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and     pharmacodynamics in healthy volunteers.   "
144953|NCT01387074|"     This is a prospective, non-interventional, observational study to collect data on the use of     botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.   "
144954|NCT01387061|"     Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains     controversial. The aim of this study was to investigate the outcome of a consecutive cohort     of patients resected for multiple HCC, without macrovascular invasion, in order to identify     clinically reliable parameters to select patients for surgery.   "
144955|NCT01387048|"     The purpose of this study is to assess the effect of Skinoren® 15% gel compared to no therapy     on the maintenance of clinical therapy success in subjects with mild to moderate acne     vulgaris previously treated for 3 months by a monotherapy of this substance and to assess the     effect of Skinoren® 15% gel, compared to Differin® 0.1% gel on the efficacy and safety during     a 9-month long-term treatment period.   "
144956|NCT01387035|"     The purposes of this study are (I), to evaluate various screening methods for their ability     to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to     evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.   "
144994|NCT01386541|"     This monocenter trial is conducted to obtain first data on safety, tolerability,     pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677     in humans. In addition, the trial should provide preliminary information on a possible     influence of sex, food intake, and posology (once or twice daily administration of BYK324677)     to support the further planning of the drug development programme.   "
144995|NCT01386528|"     This trial is conducted in Africa, Asia, Europe and the United States of America (USA).      The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog     beta pegol) during surgical procedures in patients with haemophilia B.   "
145053|NCT01385748|"     The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to     treat chemoradiation therapy induced severe oral mucositis in patients with head and neck     cancer.   "
144957|NCT01387022|"     The HIV/AIDS pandemic remains among the investigators greatest public health challenges. In     the absence of an effective vaccine, focus has shifted to other prevention strategies such as     pre-exposure prophylaxis. Tenofovir, with potent activity against retroviruses [1], was     developed for oral use as Viread®, which is widely used for HIV treatment. The efficacy of     Viread® has been demonstrated in treatment-experienced and naïve patients [2,3]. In     antiretroviral-naive patients, the combination of tenofovir with lamivudine and efavirenz has     been classified as a preferred regimen in the Department of Health and Human Services     treatment guidelines[4], and has been adopted by the South African Department of health as     the first line regimen in treatment-naïve HIV infected patients since April 2010. The     durability of antiviral response, favourable resistance profile, once daily dosing, and     excellent long term safety profile of tenofovir [5], makes this drug an attractive option in     both treatment and prevention regimens and its long half-life [6], made it an ideal choice as     the first antiretroviral drug to be formulated as a microbicide gel.      The CAPRISA 004 study conducted in South Africa which tested the effectiveness and safety of     1% tenofovir gel showed that the use of tenofovir in a gel formulation reduced HIV     acquisition by 39% overall, and by 54% in women with high gel adherence [7]. There have been     concerns raised regarding the use of tenofovir in both PrEP and treatment regimens due to the     potential for selection of viral mutations and development of resistance in patients who have     become HIV-infected while on PrEP.      There have been no studies conducted to determine whether using tenofovir in pre-exposure     prophylaxis affects treatment outcomes in patients who later use tenofovir, which is part of     the first line ART of South Africa.      This study aims to determine whether prophylactic exposure to tenofovir gel alters the     therapeutic response to a tenofovir containing antiretroviral regimen.   "
144958|NCT01387009|"     The primary objective is to establish normative data for Canadian children for the shoulder,     elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons     surrounding the joint.   "
144959|NCT01386996|"     The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.   "
144960|NCT01386983|"     This retrospective study aims to assess the clinical and economic impact of early initiation     of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP)     receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late     initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health     System databases will be utilized for this study (2000-2008).   "
144961|NCT01386970|"     This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in     men versus women and in those with versus without HIV infection. Additionally, markers of     side effects were correlated with blood levels of the drugs. The hypothesis was that women     and those with HIV would have higher drug levels, as well as markers of side effects.   "
144971|NCT01386840|"     The purpose of this study is to determine the safety and efficacy of oral amoxicillin in     treating WHO defined severe pneumonia(cough and fast breathing with lower chest indrawing) at     home and at hospital using an open labelled multicentric prospective two-arm randomized     clinical trial to determine the differences in failure of treatment with a 7 day course of     oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent     home after enrolment, in children 3 to 59 months old who have severe pneumonia. The     investigators developmental hypothesis were to test whether the community/home based oral     amoxicillin is efficacious for treating severe pneumonia.   "
145155|NCT01384409|"     To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using     multi-center, non-comparative, open-label method in patients diagnosed as disseminated     intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC     criteria.   "
144962|NCT01386957|"     Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in childhood.     Currently, all children with INS are treated at onset with steroids. The optimal duration and     dosage of steroid therapy is debated. For each patient, the challenge is to minimise     potential side effects of steroids, while achieving a good clinical response.      The aim of our study is to assess the benefits and potential adverse effects of a prolonged     initial corticosteroid regimen, for the treatment of the initial episode. The results will be     compared with data obtained retrospectively. In addition genetic studies will be undertaken     with the aim of evaluating pharmacodynamics of steroid treatment with the ultimate goal to     individualise treatment in single patients.        1. Study group: children aged 6 months - 18 years, diagnosed with an initial episode of          idiopathic nephrotic syndrome        2. Control group: data of children with a onset INS between January 2007 and December 2009          from the same area of the study group and treated with a short steroid regimen will be          retrospectively analysed and compared   "
144963|NCT01386944|"     The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome     (RLS) symptoms and augmentation in patients with augmentation associated with previous oral     dopaminergic therapy. In addition, the change in treatment regimen used when switching to     Neupro® will be evaluated.   "
144964|NCT01386931|"     This study is a multicenter prospective randomized controlled trial. Potential participants     in this study include patients referred for Endoscopic Ultrasound-guided fine needle     aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If the     patient meets inclusion criteria and signs the informed consent, they will be randomized into     one of the two study arms in a 1:1 ratio. Patients will either undergo EUS-FNA with or     without an on-site cytopathologist present during EUS-FNA. Patients assigned to the on-site     cytopathologist arm will have the cytopathologist dictate the number of fine needle     aspiration (FNA) passes performed by the endosonographer. This number will be based on the     adequacy of specimen and the ability to provide a preliminary diagnosis. In the other arm, in     the absence of an on-site cytopathologist, the endosonographer will perform a predetermined     number of 7 passes (standard of care in the absence of an on-site cytopathologist). The     technique of performing EUS-FNA (needle type, use of stylet, suction) will be standardized     among all endosonographers in order to rule out confounding factors. After EUS-FNA is     performed all slides will be sent to the pathology department. The slides will be sent for     review regardless of which arm the patient is randomized into, and they will be reviewed by     experienced cytopathologists for the purpose of determining the final diagnoses.      Future clinical intervention will be monitored for the purpose of reporting the impact     EUS-FNA has on the patient's clinical course and determining diagnostic accuracy. Patients     will be followed prospectively for at least one year, and the gold-standard for final     diagnosis of pancreatic malignancy will be defined by the presence of malignant cytology or     histologic evidence (if the patient undergoes surgery) or with clinical and/or imaging     follow-up consistent with pancreatic cancer (death or clinical progression). A detailed     account of medical equipment used during each procedure, procedure time, clinic     visits/hospitalizations due to procedure related complications, and number of repeat     procedures will be recorded systematically.      The investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic     masses improves diagnostic yield, accuracy, and lowers the duration, complications and the     need for repeat procedures.   "
144965|NCT01386918|"     Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for     refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of     studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz)     to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation     (hereby simply referred to as priming) has been shown to enhance the neurophysiological     effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore,     this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to     the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).   "
144966|NCT01386905|"     The purpose of this study is to assess the feasibility of the TransPyloric Shuttle™ (TPS™)     when used to treat obesity.   "
144967|NCT01386892|"     This study seeks to obtain normal samples of blood, saliva and urine to serve as controls for     other approved protocols and for analysis. These include determination of the functional     capabilities of cells, proteins, nucleic acids and microvesicles obtained from peripheral     blood including plasma, serum and cellular fraction from normal individuals. Saliva and urine     will have similar testing which may also be compared to the blood testing results. The     ongoing objective varies from investigation to investigation but in general the     investigational goals are to better understand the immune function of normal volunteers and     compare it to immune function in disease states.   "
144968|NCT01386879|"     The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation,     amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug     Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in     the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a     significant reduction in the incidence of ventilator acquired pneumonia when a ETT with     suction above the cuff is used to remove secretions that accumulate above the inflated cuff.     This will be the first study to evaluate the efficacy of above the cuff suctioning during     general anesthesia and surgery.      One hundred and ten adult patients undergoing elective abdominal surgery (general, colorectal     or gynecological) requiring general anesthesia with an endotracheal tube and mechanical     ventilation will be randomized into 3 groups to receive one of the following three     endotracheal tubes:        1. Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port          Endotracheal Tube (Teleflex ISIS ETT).        2. Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).        3. Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)      The first two groups will be compared to standard ETT (third group) regarding easy of     tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea     with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the     pharynx into the trachea and incidence of post-operative respiratory complications.   "
144969|NCT01386866|"     In order for a tumour to grow and spread to other parts of the body, it needs to have a blood     supply. Certain proteins in the body, called cytokines or growth factors, have been shown to     cause the growth of new blood vessels that supply tumours and therefore help the tumour to     grow and spread. Motesanib (AMG 706) prevents these proteins from working, and may help to     prevent the growth of tumours.      In the first part of this study, we will look at the way your body absorbs this drug into     your blood, how your body changes and breaks down the drug, and then how the drug leaves your     body in your urine and faeces.      In order to provide potential treatment benefit for the subjects who participated in the     first part of the study, the second part of the study will allow subjects to continue on     motesanib (AMG 706) treatment. The estimated length of this part of the study is unknown, and     dependent on how subjects respond to motesanib (AMG 706).   "
144970|NCT01386853|"     This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority     study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and     atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.   "
144972|NCT01386827|"     The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to     cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The     present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro.      Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune     responses in four groups: A) primary immunization with BMJEV, B) primary and secondary     immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization     with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of     serum samples collected before and after vaccination.   "
144973|NCT01386814|"     Aim: To evaluate the influence of oxygen deficit on the cognitive performance and also about     the architecture and sleep efficiency in volunteers subjected to mild and moderate exercise     in a hypobaric chamber. SUMMARY: Participants in this study 30 healthy male volunteers, aged     20 to 40 years, regular physical activity, constituting three groups: 1 - without     exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in     hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10     volunteers who will undergo a protocol exercise physical sea-level, 3 - group exercise and     hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same     in condition of hypoxia (hypobaric chamber). All groups on the first day of the experiment     will undergo baseline assessments, laboratory blood analysis salivary and spirometric     testing. Assessments will be personality and neuropsychological. After baseline assessments,     the last day of the experiment, the groups will be evaluated again 4350m above sea level the     sea, by personality tests, neuropsychological and laboratory. RATIONALE AND BACKGROUND:     During exposure to environments with a partial reduction of oxygen, human body can undergo     several physiological and psychological changes are not prepared for such condition. Few     studies have reported that the elevation changes and cognitive aspects related to sleep.      MATERIAL AND METHOD: They describe the procedures to be performed, and the study conducted in     local with adequate infrastructure.   "
144974|NCT01386801|"     Blood samples and health information (e.g., age at diagnosis, test results) are collected for     the purposes of genetic research. The blood samples are assigned a number and stored in a     repository for safe keeping until they are needed for a research project. Participants are     persons who are healthy (not having high blood pressure, diabetes, or high cholesterol     levels) or persons who have Diabetes Mellitus Type II(T2D) and live in Indiana. Participants     complete a questionnaire at the time the blood sample is drawn. Visits are repeated at 2 and     5 years after initial contact. Researchers apply to the Fairbanks Institute for use of the     blood samples and health information minus participant names and contact information. Their     research is required to be related to find genes or substances made by genes that may be     involved in Diabetes Mellitus Type II with the purpose of improving the investigators     understanding of the illness potentially leading to the development of new diagnostic tools     for identifying the illness, new treatments,or preventative measures.   "
145054|NCT01385735|"     The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct     therapy to levodopa) on affect perception and emotional expressiveness in a double-blind     placebo-controlled study.   "
144975|NCT01386788|"     Cyanide poisoning is commonly viewed as a rare but dramatic event, occurring in industrial or     laboratory settings as the result of accidental releases of hydrogen cyanide (HCN) gas (e.g.     in the case of fire) or salts in the case of suicide attempts.      In fact, cyanide poisoning is considerably more common than is generally appreciated.     Multiple clinical and post-mortal studies have demonstrated that HCN contributes to the     toxicity of fire smoke.      Cyanide acts primarily through its strong affinity for the iron-containing heme moiety,     binding to numerous critical enzyme systems in the body and rendering them inactive. Of late,     increasing attention has been paid to the relationship of cyanide and nitric oxide. The     interactions appear to be complex, with cyanide inducing nitric oxide production by binding     to N-methyl-D-aspartate (NMDA) receptors, as well as binding to nitric oxide synthase. The     latter may be overcome by the presence of nitric oxide synthase inhibitors.      Probably, the majority of the cyanide poisoning cases are due to smoke inhalation in     closed-space fires.      So far, there are no clear data available on the prevalence of cyanide poisoning in smoke     inhalation.      This information would be of great interest for all emergency physicians since a proven or     supposed cyanide poisoning does not only requires an intensive supportive care, including the     administration of supplemental oxygen and artificial ventilation, blood pressure support, and     anticonvulsants, but also a rapid administration of a cyanide antidote.      Therefore, it is the goal of this survey to assess the prevalence of cyanide poisoning in     smoke inhalation victims. Only the data of patients with a cyanide measurement before     specific antidote treatment will be included   "
144976|NCT01386775|"     This study in affected Hypohidrotic Ectodermal Dysplasia (HED) males and unaffected male     controls, age 1 year and up, will use minimally invasive devices to image sweat ducts in     intact skin, to measure stimulated sweat rate, and in a subset of subjects to collect clipped     scalp hair samples for RNA analysis. This study is descriptive in nature and is intended to     assess the ability to use innovative approaches to generate data from subjects over a wide     age spectrum, with particular emphasis on phenotype variability between male siblings (same     mutation).   "
144977|NCT01386762|"     Bone loss is a common secondary complication of spinal cord injury (SCI), and treatments used     to reverse this condition have equivocal effectiveness. The aim of this study is to determine     the effect of intense multi-modal training on bone health, body fat, and quality of life in     persons with SCI. Participants will complete 6 months of training during which various     measures will be obtained at 0, 3, and 6 months. Control subjects are also being recruited to     complete testing but not participate in training.   "
145017|NCT01386216|"     The purpose of this study is to evaluate the safety of administration of marrow-derived     autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for     the treatment of Critical Limb Ischemia (CLI).   "
145072|NCT01385501|"     This research project will develop an educational intervention to improve immunization     acceptance by vaccine hesitant parents. This is prospective interventional case-control     trial, where the investigators will provide the intervention in the clinical setting.     Enrollees will be screened and selected if they meet criteria for vaccine hesitancy. The     investigators will conduct follow up surveys following the intervention to assess change in     attitude and follow immunization rates through 18 month well visit.   "
144978|NCT01386749|"     Diaphyseal long bone fractures are usually associated with high energy trauma in which     femoral shaft fracture is one common fracture in young age group. Surgery is usually needed     for the diaphyseal lone bone fractures and the painful conditions always hinder weight     bearing which is important for fracture healing and functional recovery. Fracture healing in     cortical bone is less predictable than trabecular bone because they are less active and blood     supply is more critical. Therefore accelerating fracture healing and rehabilitation of long     bone fracture will absolutely bring significant economic benefit to the society in term of     hospitalization and sick leave cost.      Low-magnitude, high-frequency vibration (LMHFV) treatment can provide systemic mechanical     stimulation and is reported with multiple effects on musculoskeletal tissues. LMHFV can     enhance the blood circulation and osteogenic effect in normal subjects and animals. Our     previous clinical study also indicated that LMHFV could enhance the balancing ability and     muscular function in normal post-menopausal women after treating whole-body vibration. For     the fracture healing effect, an acceleration of healing by inducing callus formation and     maturation in rat model was also reported in our previous studies.      In this study a total of 50 unilateral closed femoral shaft fracture patients of either     gender aged 20-40 years old will be recruited and they will be randomized to either control     and vibration group. The vibration group will be treated with LMHFV for 6 months. The     findings of this study will provide very useful scientific data to support the application of     LMHFV for fracture healing.   "
144979|NCT01386736|"     The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates that     the physiologic functions of vitamin D are much broader than its well-known role in the     regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is     involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type     I diabetes. Recent epidemiological evidence points to a strong association between vitamin D     insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The     investigators would like to examine the role of vitamin D in the development of insulin     resistance in overweight children and adolescents, which represent a high risk population for     cardiovascular and metabolic complications. The investigators propose a prospective     randomized clinical trial of vitamin D supplementation in overweight, insulin resistant,     vitamin D deficient children. The investigators objective is to assess if changes in insulin     resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these     patients post treatment with vitamin D. Additionally, concomitant changes in calcium and bone     metabolism after vitamin D treatment will be evaluated. This is because, contrary to adults,     the optimal vitamin D concentrations that regulate calcium and bone metabolism have not been     established in pediatrics.   "
144980|NCT01386723|"     This study proposes to observe whether a stable platelet count would be maintained without     additional treatment in the long term in at least a proportion of patients who have     discontinued eltrombopag taken for at least 4 months. This requires that if patients stop     treatment with eltrombopag, they are not immediately transitioned to further treatment unless     it is necessary.      The objective of the study is to assess how frequently patients who have discontinued     eltrombopag attain a stable, treatment-free, unmaintained adequate platelet count 4 to 8     weeks after discontinuing eltrombopag and how long such a response lasts (if it occurs).   "
145009|NCT01386320|"     Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and     is very painful. Local anaesthetic nerve blocks have been used for many years to help     alleviate pain following this surgery. The present study aims to compare a new ultrasound     guided nerve block to a well established nerve stimulator guided technique. Comparisons will     include time taken to carry out the block, speed of onset of numbness and duration and     quality of pain relief after surgery.   "
144981|NCT01386710|"     The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic     astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of     tumors also exhibits the most aggressive behavior, resulting in median overall survival     durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of     either surgical resection, external beam radiation or both. All patients experience a     recurrence after first-line therapy, so improvements in both first-line and salvage therapy     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently     used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators     have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral     Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of     recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that     trial in that the investigators seek to test the hypothesis that repeated dosing of     intra-arterial Bevacizumab is safe and effective in the treatment of recurrent malignant     glioma. Additionally the investigators will analyze if a combination with IA Carboplatin will     further improve the treatment response. By achieving the aims of this study the investigators     will also determine if IV therapy with Bevacizumab with IV Carboplatin should be combined     with repeated selected intra-arterial Bevacizumab plus Carboplatin to improve progression     free and overall survival. The investigators expect that this project will provide important     information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma,     and may alter the way these drugs are delivered to the investigators patients in the near     future.   "
144982|NCT01386697|"     The overall objective is to estimate the actual or potential benefit of deep inspiration     breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3     dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy (IMXT),     as it relates to variability in tumor localization, treatment margins, target volume     definition, doses to organs at risk and variations with treatment planning.   "
144983|NCT01386684|"     The purpose of this study is to evaluate the Canadian Real Life Evaluation of the     Effectiveness of Lupron in the Management of Prostate Cancer.   "
144984|NCT01386671|"     The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus     Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican drug naïve     type 2 diabetes patients, in a 12 months follow up.   "
144985|NCT01386658|"     HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the     Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single     subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with     Hereditary Angioedema (HAE) during an initial acute attack.   "
144986|NCT01386645|"     The study will determine if increasing the highs and lows of blood glucose levels (glycemic     variability) impairs insulin secretion in people with impaired glucose tolerance and/or     impaired fasting glucose who are at risk for developing type 2 diabetes. Furthermore, the     study will determine whether changes in beta-cell function are associated with glycemic     variability and whether they are mediated by oxidative stress. To decrease or increase     glycemic variability the study will provide subjects with special diets containing either low     or high glycemic index foods respectively for 4 weeks. To determine if oxidative stress is a     mediator, subjects on the high glycemic index diet will take either placebo or the     anti-oxidant N-acetylcysteine. The study will address the hypothesis that increased glycemic     variability results in increased oxidative stress and thereby exacerbates beta-cell     dysfunction in individuals with impaired glucose tolerance and/or impaired fasting glucose.     The findings may have important implications for the development of effective strategies     aimed at the prevention and treatment of type 2 diabetes. In addition, understanding the     contribution of dietary glycemic index to beta-cell dysfunction in subjects with pre-diabetes     may have a significant public health impact, including changes to dietary counseling and     promotion of healthier eating patterns.   "
144987|NCT01386632|"     This will be a randomized masked placebo-controlled single-center study to evaluate the     effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and     radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and     Neck (SCCHN). Fifty subjects will be enrolled and randomly assigned on a 1:1 ratio to DCA or     matching placebo given with standard of care treatment consisting of Cisplatin and radiation     treatment.      Patients will receive DCA/placebo PO or per G-tube twice a day for 8 weeks. The first 6     patients of the total study population will represent a safety lead-in cohort. The results of     the safety lead-in of DCA/placebo in combination with Cisplatin and radiation therapy will be     evaluated after the 6th patient has completed 8 weeks of therapy. Recruitment of patients     will be withheld during safety data analysis.   "
144988|NCT01386619|"     This is a phase I/II study of highly selected donor lymphocyte infusions in patients     undergoing HLA-haploidentical hemopoietic stem cell transplantation. Patients will be offered     pre-emptive NK-DLI early after HSCT.      Three schedules of NK-cell infusion will be studied: Basel patients (adult and pediatric)     will receive NK-DLI on days +40 and +100 (pre-emptive-late); Frankfurt patients (pediatric)     will receive NK-DLI on days +3, +40, and +100 (pre-emptive early). Patients not receiving     pre-emptive NK-DLI with loss in donor chimerism or with evidence of minimal residual disease     will be offered therapeutic NK-DLI.   "
144989|NCT01386606|"     The study will determine the effects of three doses of Androxal(enclomiphene citrate)on     morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone     (<350 ng/dL)after 6 weeks of continuous dosing.   "
144990|NCT01386593|"     The purpose of this study is to assess how the pharmacokinetic profiles of each drug of a     cocktail of six approved drugs (so-called Basel cocktail) change when the cytochrome P450     system is inhibited or induced.   "
144991|NCT01386580|"     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK)     of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study     will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with     with solid tumors and brain metastases or recurrent malignant glioma as well as in patients     with various forms of breast cancer with and in combination with trastuzumab in HER2+ breast     cancer patients with brain metastases.   "
145010|NCT01386307|"     The purpose of this study is to determine the prevalence of patients with acute and chronic     pain in the area of inpatient at the Hospital Italiano de Buenos Aires.   "
144996|NCT01386515|"     Background:      We want to learn more about the relationship between the way families function and how     children adapt to having a sibling with Duchenne muscular dystrophy (DMD). What we learn will     help us design better interventions for families.      Objective:        -  To learn more about how families with an individual with DMD function.        -  To learn how siblings adapt in families with an individual with DMD.      Eligibility:        -  One parent and one child, age 13-18, from a family where another child has DMD.        -  The parent and the child must be able to read and write English.      Design:        -  One parent from each family will complete a survey about how family members communicate          and relate with each other. The parent will also answer questions about the behavior of          the child without DMD. This survey will take you about 40 minutes to complete.        -  One child from each family, either a boy or a girl, will also complete a survey. This          survey asks about how he/she views him/herself. It also asks about how he/she interacts          with peers and family members and how he/she behaves. The survey also asks how satisfied          he/she is with how his/her family functions. This survey takes about 30 minutes to          finish.   "
144997|NCT01386502|"     Background:        -  The p53 gene normally helps to stop cancer cells from growing. However, when the p53          gene is mutated or damaged, cancer cells may grow unchecked. Researchers have been          working on a vaccine that will help the immune system recognize and destroy cells that          have the p53 mutation and may be cancerous.        -  CT-011 is another drug that may help the body's immune system to fight cancer. This drug          blocks a chemical found on tumor cells that prevents the immune system from recognizing          and destroying them. Research studies have shown that CT-011 slows the growth of tumors.          By combining the p53 vaccine and CT-011, researchers hope to slow or stop tumor growth          in people whose cancer that has not responded to standard treatments.      Objectives:      - To test the safety and effectiveness of CT-011 and the p53 genetic vaccine to treat adults     with solid tumors that have not responded to standard treatments.      Eligibility:      - People at least 18 years of age who have solid tumors that have not responded to standard     treatments.      Design:        -  Participants will be screened with a medical history and physical exam. They will also          have blood tests and tumor imaging studies.        -  Participants will receive the p53 vaccine as an injection in the arm or thigh.        -  Two days after receiving the p53 vaccine, those in the study will receive CT-011 as an          infusion over about 2 hours. Participants will be monitored during the infusion for any          side effects.        -  The combination of p53 vaccine and CT-011 will be repeated every 3 weeks (one cycle).          Treatment will continue as long as the side effects are not severe and the tumor does          not grow.        -  Three weeks after the second dose of p53 vaccine and CT-011, participants will have a          full physical exam. They will also have blood tests, and tumor imaging studies. This          exam set will be repeated after every two cycles of p53 vaccine and CT-011.        -  Participants will have regular follow-up visits for up to a year after stopping          treatment.   "
145031|NCT01386034|"     The specific aim of this study is to determine whether oral citrulline administration     enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism     will be assessed using an intravenous infusion of stable isotope labeled leucine. The     investigators hypothesize that citrulline supplementation will decrease leucine oxidation     without altering proteolysis, and consequently stimulate protein synthesis.   "
144998|NCT01386489|"     Background:      The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for     HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response     to two experimental HIV vaccines currently in development at the VRC. One is known as the     rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces     of manufactured DNA. They do not contain live or killed HIV. It is impossible for study     vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these     experimental vaccines have been given to people before in other research studies. They have     not been approved for treating or preventing HIV infection.      Purpose:      The main purpose of this study is to look in detail at the body s immune responses after the     experimental HIV vaccines are given and to assess safety of the study vaccines.      Eligibility:      Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet     the eligibility requirements.      Design:      Participants will be screened with a medical history (including questions about sexual     history and drug use), physical exam, and blood tests.      The study will have two groups:      <TAB>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over     3 months.      <TAB>The second group will have three injections of the DNA vaccine, one injection of the     rAd5 vaccine, and have 12 clinic visits over 6 months.      All participants will be asked to provide blood and body fluid samples for testing during the     study.      Payment for participation will be provided.   "
144999|NCT01386476|"     Background:      - The blood-brain barrier helps protect the brain from infections and toxins in the blood     stream. But it can also prevent certain drugs from reaching the brain to treat diseases or     other problems. Researchers are interested in chemicals that will help show how the barrier     works. One possible chemical, (18F)FCWAY, may be useful for studying the barrier. More tests     are needed to determine how effective it is.      Objectives:      - To test whether (18F)FCWAY can be used to help study the blood-brain barrier.      Eligibility:      - Healthy volunteers between 18 and 50 years of age.      Design:        -  This study requires a screening visit and two scanning visits.        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests.        -  At the first scanning visit, participants will have a magnetic resonance imaging scan to          provide baseline images of the brain.        -  Before the second visit, some participants will stay overnight in the hospital. They          will receive the drug tariquidar, which may help the (18F)FCWAY show the blood-brain          barrier more clearly.        -  At the second scanning visit, all participants will have a positron emission tomography          scan with (18F)FCWAY to see how well the drug shows the blood-brain barrier on the scan.   "
145000|NCT01386437|"     Background:      - The immune system is made up of special cells, tissues, and organs that fight infections.     Problems with this system may lead to frequent, severe, or unusual fungal infections. These     infections are often difficult to treat. Researchers want to collect blood and tissue samples     from people who have unusual, persistent or severe fungal infections or immune problems that     increase the risk of these infections.      Objectives:      - To collect medical information and samples for a long-term study of people with immune     system problems that lead to fungal infections.      Eligibility:        -  People with a history of fungal infections caused by immune system problems.        -  Parents, children, and siblings of this group.        -  Healthy volunteers not related to the first two groups.      Design:        -  This long-term study may last for up to 10 years. Those in the study may need to provide          new information about every 6 months. The procedures for each person may vary with the          particular diagnosis and the extent of fungal infection. Healthy volunteers may have          only one or two visits.        -  At the first visit, those in the study will have a full medical history and physical          exam. They will also provide blood.        -  Research procedures may include the following:        -  Saliva, urine or stool testing        -  Mouthwash collection for DNA testing        -  Collection of cheek cells, nail clippings, or vaginal fluid        -  Tests of leftover tissue or body fluid from previous medical procedures        -  Skin or oral mucous membrane biopsy        -  Collection of white blood cells        -  Followup visits will involve a physical exam and updated medical history. Blood, saliva,          urine, or nail clipping samples may be taken for ongoing studies. Any additional tests          or exams required by the study doctors may also be done.        -  Participants may withdraw from the study pool at any time.   "
145011|NCT01386294|"     The purpose of the study is to assess the safety and effectiveness of intravaginal 1%     tenofovir gel in preventing Human Immunodeficiency Virus (HIV-1) infection and Herpes Simplex     Virus (HSV-2) infection in sexually active women.   "
145012|NCT01386281|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Julina for postmenopausal     osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in     clinical practice. A total 100 patients will be recruited and followed 3 years since starting     Julina administration.   "
145001|NCT01386424|"     Background:      - Influenza (the flu) is highly infectious and contagious. It causes considerable illness in     the United States each year. The most severely affected are the very young, sick, and     elderly. Researchers want to find healthy volunteers for influenza challenge studies. In     these studies, doctors expose a person to a flu virus. Then they study the flu through the     body's natural healing process. This information will help to find better ways to prevent the     flu. It may also improve the treatment of people who get the flu.      Objectives:      - To screen healthy volunteers for future influenza challenge studies.      Eligibility:        -  Healthy people between the ages of 18 and 65 who do not routinely smoke.        -  People who share the same apartment or house with people at least 65 years of age or          children under age 5 will not be eligible.        -  People who share living quarters with nursing home residents, people with chronic or          acute medical conditions, or people with cancer or a compromised immune system are also          ineligible.      Design:        -  The 3- to 5-hour screening exam includes the following:        -  Medical history and physical exam        -  Standard blood tests including pregnancy and HIV tests        -  Standard urine drug testing        -  Electrocardiogram (ECG) to test heart rhythm and function        -  Chest x-ray        -  Eligible volunteers are enrolled in the study for up to 1 year, until they take part in          a virus challenge study, or are found to be ineligible to participate.        -  Volunteers may withdraw from the study pool at any time.   "
145032|NCT01386021|"     The primary objective of this observational study is to evaluate the function (patency) of     cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for     patients with occlusive coronary artery disease.   "
145033|NCT01386008|"     The purpose of this study is to evaluate the performance of the investigational CooperVision     silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to     30 days of daily lens wear.   "
145156|NCT01384396|"     To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using     multi-center, non-comparative, open-label method in patients diagnosed as disseminated     intravascular coagulation (DIC) by the diagnostic criteria for DIC established by the     Japanese Ministry of Health and Welfare.   "
145002|NCT01386411|"     Genes are the blueprints for our bodies. Some people are born with an abnormal copy     (mutation) of a gene. These people may have a higher chance of getting a disease. Different     mutations in different genes cause different diseases. Some women get breast cancer because     they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These women also have a     higher chance of getting ovary cancer. Women with breast cancer and an abnormal copy of BRCA1     or BRCA2 also have a higher chance of getting a second breast cancer in their other breast.     Because of this, women who might have a mutation may have genetic testing soon after their     breast cancer diagnosis to learn about their risks of getting another cancer.      Genetic testing may be done right after a woman has been diagnosed with breast cancer. It may     also be done later, after surgery is done to treat the cancer. The investigators do not know     when it is best to do genetic testing. The investigators are doing this study to try to     understand whether women prefer testing before or after surgery. The investigator also want     to find out how they feel about their choice later on, when their diagnosis in more in their     past.   "
145003|NCT01386398|"     RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of     the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective     when given alone or when given together with bortezomib in treating patients with refractory     or recurrent cutaneous T-cell lymphoma.      PURPOSE: This randomized phase III trial is studying how well vorinostat works when given     alone compared with vorinostat given together with bortezomib in treating patients with     refractory or recurrent stage IIB, stage III, or stage IV cutaneous T-cell lymphoma.   "
145004|NCT01386385|"     This phase I/II partially randomized trial studies the side effects and best dose of     veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see     how well it works in treating patients with stage III non-small cell lung cancer that cannot     be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells     and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in     different ways to stop the growth of tumor cells either by killing the cells, by stopping     them from dividing, or by stopping them from spreading. It is not yet known whether radiation     therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating     non-small cell lung cancer.   "
145005|NCT01386372|"     Hyponatremia is a common electrolyte disorder encountered in hospitalized patients. A     preliminary, observational, feasibility analysis finalized to assess retrospectively the     incidence of hyponatremia (Serum sodium < 135 mEq/L) in a general medical-surgical hospital     and the distribution of the cases of hyponatremia among different referral units showed that     over one year observation there were more than 1500 cases of hyponatremia. Conventional     therapy for hyponatremia depends on its causes, speed of onset, extracellular fluid volume     status, and severity. Treatment consists in fluid restriction, normal or hypertonic saline,     furosemide. Recent development of arginine vasopressin antagonists has provided a new     therapeutic option for treatment of hyponatremia.Tolvaptan, an orally administered,     nonpeptide, selective vasopressin V2 receptor antagonist reported to increase free water     clearance and limit fluid retention in subjects with congestive heart failure or liver     cirrhosis, has been also shown to be effective in the treatment of chronic hyponatremia in     patients with SIADH, chronic heart failure, liver cirrhosis. Thus the investigators designed     a clinical study to explore the incidence of severe hyponatremia in hospitalized patients in     the setting of large general hospital and to evaluate whether tolvaptan is effective and safe     in increasing serum sodium concentration in patients with normovolemic and hypervolemic     hyponatremia in the setting of daily clinical practice. Moreover this study may help     understand the cost-effectiveness of tolvaptan therapy compared to traditional treatments of     hyponatremia.   "
145006|NCT01386359|"     To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant     Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive     Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant treatment,     occur in patients taking Nulojix (belatacept) in a real-world setting.   "
145007|NCT01386346|"     The purpose of this study is to see whether giving azacitidine before each cycle of     chemotherapy prior to surgery is safe.   "
145008|NCT01386333|"     Oxytocin is a hormone produced by the brain that appears to have important roles in social     cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin     on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia     were investigated. The results from the pilot study suggested that oxytocin may be associated     with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal     Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the     present study will examine the safety and tolerability of three different doses of intranasal     oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.   "
145014|NCT01386255|"     Despite the use of proton pump inhibitors and available prokinetics, medical therapy is     ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal     reflux disease (GERD), and failure of medical therapy is associated with a substantial     morbidity. Many patients, particularly children with CP and GERD, continue to experience     complications despite aggressive therapy because antisecretory medications do not address the     primary reflux mechanism (TLESR). Furthermore, in patients with CP, surgical options are     fraught with serious complications and long-term morbidity. Because the available treatment     options for children with CP and intractable GERD are limited, new therapies are urgently     needed. Baclofen, which has been shown in animals and humans to decrease TLESRs, may be a     good alternative for the treatment of children with CP with intractable GERD.   "
145015|NCT01386242|"     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor     and anti-virus protein for injection in treating patients with metastatic colorectal cancer     after failure of second-line and more than second-line treatment.   "
145016|NCT01386229|"     The aim of this study is to determine whether ketamine is an acceptable alternative to     etomidate for anesthesia induction in coronary artery bypass graft surgery in terms of     hemodynamic stability and also to compare these agents regarding their effect on adrenal     gland steroid synthesis in these patients.   "
145018|NCT01386203|"     Analysis of volatile organic compounds (VOCs) is a new attractive non-invasive field in     medical diagnostics. These VOCs can be detected via the exhaled breath.      Together with Prof Haick group at the Technion Inst (Israel), the investigators data shows     that there is a relation between the VOCs patterns of NSCLC and control cell lines and     equivalent states in exhaled breath. The investigators demonstrated that there is a clear     discrimination between the lung cancer and the healthy clusters . The investigators also     analyzed the headspace of NSCLC and SCLC cell lines and the investigators could discriminate     significantly between SCLC versus NSCLC based on their VOCs patterns. This analysis allowed     us to identify the specific VOCs consumed or omitted by cancerous cells. Therefore, a     non-invasive and highly sensitive test would be extremely valuable for the classification and     early screening of lung cancer and for targeted therapy. In this study, the investigators     will monitor the VOC pattern of patients with lung cancer as well as high risk cohort and     patients under risk/evaluation for lung cancer. Likewise the investigators will monitor pts     under and after therapy. In addition, the investigators will compare teh breath signature to     other biomarkers of lung cancer, like circulating tumor cells and others.   "
145019|NCT01386190|"     This research consists of a novel intervention designed to increase physical activity of     premature babies in their first year of life. The potential beneficial impact of augmented     physical activity on:        1. Body composition        2. Associated biochemical and cellular mechanisms of growth and inflammation        3. Quality of maternal care will be measured   "
145020|NCT01386177|"     The purpose of this study is to determinate the effect of a pre-treatment with doxazosin, a     alpha1-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of     3,4-methylenedioxymethamphetamine (MDMA, ecstasy). The investigators hypothesize that     doxazosin will attenuate the cardiovascular and subjective response to MDMA.   "
145021|NCT01386164|"     The purpose of this study is to analyze and compare the immunogenicity of Bivalent and     Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.   "
145022|NCT01386151|"     This study will look at the permeability, or 'leakiness' of the airway epithelium (the inner     lining of the lung) in asthmatic patients. Increased leakiness of this lining has been shown     in asthmatic patients by other studies, not only in the lung but also possibly in the gut,     perhaps reflecting a widespread defect. This leakiness may underline the interaction between     the environment and a person's genetic make up, and may contribute to why some people get     asthma, and how severe it is. Increased leakiness may allow increased exposure to inhaled     allergic substances, helping to perpetuate the inflammation in the lungs that is a hallmark     of asthma.      Specifically, this study will attempt to modify and reduce this permeability through the use     of a substance called 'keratinocyte growth factor', or 'kgf'. KGF is a naturally occuring     human protein, which is involved in stimulating the growth of cells lining the layers of the     skin and gut, helping to repair damage and maintain their structure. It has been manufactured     in a laboratory as the commercial compound 'Palifermin', which has already been used in     humans to reduce damage to the lining of the mouth after chemotherapy. The study will see if     Palifermin can similarly improve the lining of the lung in asthma patients and improve their     symptoms. To date no treatments have been used in this area in asthma, and if successful the     study will open up a whole new area of therapy   "
145023|NCT01386138|"     The purpose of this study was to develop and initially evaluate an efficacious,     comprehensive, culturally sensitive, women-centered model of care for pregnant South African     women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the     same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's     Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC.   "
145024|NCT01386125|"     This study will evaluate the effectiveness and safety of MFNS in improving nasal     congestion/obstruction and in reducing bilateral nasal polyps.   "
145025|NCT01386112|"     Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by     eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological     treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by     published case series and controlled trials in children and adults, the most widely used drug     treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal)     action.      This study will evaluate the safety and tolerability of orally administered EUR-1100 once or     twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The     Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening     visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom     assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.   "
145027|NCT01386086|"     Currently there are no controlled data on the management of postpartum depression that fails     to respond to adequate antidepressant therapy. The investigators recently reported that a     large number of patients responded to the addition of atypical neuroleptics after having     failed antidepressant trials. Aripiprazole used adjunctively to antidepressants is effective     in patients with resistant depression but it has not been studied in patients with resistant     postpartum depression. The investigators propose to conduct a 6 week open-label study to     assess the effectiveness and tolerability of aripiprazole used adjunctively to     antidepressants in patients with resistant postpartum depression.   "
145028|NCT01386073|"     The purpose of this study is to compare the efficacy of FreshKote and Systane for the     reduction of dry eye signs and symptoms.   "
145029|NCT01386060|"     The study purpose is to evaluate efficacy of a mindfulness training intervention and learn     about cognitive and physiological markers of stress.   "
145030|NCT01386047|"     Clinical prediction rules (CPRs) are frontline decision aids that help physicians make     evidence-based, cost-effective decisions that benefit their patients. The aims of this     project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule     and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record     System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated     CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).   "
145694|NCT01377350|"     The purpose of this study is to explore the feasibility of monitoring hemodynamic changes,     which result from heart failure exacerbations, by recording the respiratory effort, chest     wall dynamics and quantifying the development of dyspnea by using miniature mechanical     sensors that are attaches to the chest.   "
145034|NCT01385995|"     The investigators performed a randomized, cross-over controlled clinical trial comparing 8     weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with     moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A     rigorous assessment of metabolic responses to SDB treatment in this group is of great     clinical significance because this sample is at high risk for developing diabetes. The     paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of     both primary care and sleep medicine.   "
145035|NCT01385982|"     Clinically significant test results require timely clinician follow-up including the     non-urgent clinically significant, or actionable, test results that have received less     standardized management and attention. Unfortunately, failure to correctly manage actionable     test results is not infrequent and may be associated with important delays in diagnosis and     treatment and patient harm. The investigators have designed a safe practice intervention to     improve the management of actionable test results for ambulatory patients in a large     healthcare system.   "
145036|NCT01385969|"     The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and     allowing them to recoil will put the pressure of the LMA cuff within the safety range. It     will also determine if remaining within this safety range has an effect on complications     after surgery..   "
145037|NCT01385956|"     The goal of this clinical research study is to learn if the study drug SOM 230 in addition to     standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The     safety and tolerability of different doses of SOM 230 will also be studied. The participants'     physical state, changes in the size of the tumor, and laboratory findings taken while     on-study will help us (the study doctor and Moffitt Cancer Center) decide if SOM 230 is safe     and effective.   "
145038|NCT01385943|"     The goal of this study is to test a protocol that uses clinical pictures, confocal     reflectance microscopy images and dermoscopic information in a telemedicine platform. This     protocol will test the technologies and diagnostic performance of dermoscopy and confocal     reflectance microscopy in a randomized prospective multicenter study in five different     centers in Europe.   "
145039|NCT01385930|"     The aim of the study is to evaluate self-reported adherence to and the effects of an     intervention model consisting of individualized prescribed dietary advice (DAP) in     combination with Motivational Interviewing (MI), social support and mobile services in obese     patients in primary health care. The specific aim is to relate effects of the intervention     model to self-reported health, biomarkers for coronary heart disease, diabetes, some cancer     forms, sleep duration and quality, health economy, oral health, dietary intake and physical     activity.      This is a two-armed randomized controlled study. The arms are: 1) Control group (care as     usual) and 2) Experimental group (MoR). The volunteers will be consecutively, for each sex,     randomized to the experimental and the control group, respectively.      The experimental group will receive DAP together with Motivational interviewing up to six     months after the start of the study. From six months up to 24 months the participants will     receive social support online and mobile services.      The control group will receive dietary information according to the Habo model. The     previously mentioned diet will be recommended to both the control group and the experimental     group since it is the method in which the investigators give the information they want to     study and not the diet per se. Thus, it is only the way the investigators give dietary     information that differs between the groups.      The study also includes qualitative interviews. The aim of these studies is to gain     understanding of patients' and health professionals' experience and attitudes around food,     lifestyle and support functions associated with dietary change. The sampling approach     involves the purposeful selection of cases with a wide range of variation, which means that     the researcher selects people who are able to provide rich information about the current     issue. To achieve diversity, it is useful that both women and men are involved in the     studies, as well as people of different ages and with different experiences of providing or     receiving dietary advice. About 15-20 people will participate in each interview study.   "
145040|NCT01385917|"     PreU7-53 is a natural history study. The objective is to monitor the clinical and     radiological course of upper limb muscle impairment in patients with Duchenne Muscular     Dystrophy (DMD), potentially treatable with AAV-mediated exon 53 skipping.   "
145055|NCT01385722|"     A research study to learn about the biologic features of cancer development, growth, and     spread. We are studying components of blood, tumor tissue, normal tissue, and other fluids,     such as urine, cerebrospinal fluid, abdominal or chest fluid in patients with cancer. Our     analyses of blood, tissue, and/or fluids may lead to improved diagnosis and treatment of     cancer by the identification of markers that predict clinical outcome, markers that predict     response to specific therapies, and the identification of targets for new therapies.   "
145041|NCT01385904|"     The purpose of this research study is to measure how much, if any, ketamine is absorbed into     the blood stream after ketamine gel is applied to the skin. The investigators expect that the     topical administration will provide pain relief locally, at the site of pain, but not be     absorbed into the bloodstream and thus not cause side effects. This research will help assess     the safety of this drug by measuring the blood concentrations of the drug.      Ketamine is a general anesthetic drug but also has excellent pain relieving qualities. It has     been used to relieve chronic pain by administering intravenously, by mouth, or as an     injection beneath the skin. When given these ways ketamine can occasionally cause side     effects like dizziness, nausea, nightmares, agitation, hallucinations. Recently it has been     used topically for patients with neuropathic pain in order to avoid the dizziness and nausea     side effects.      Neuropathic Pain can be partially caused by the misfiring of small nerve fibers close to the     area of pain. By applying it on the skin, it is expected the drug can penetrate the skin and     act directly on the small nerve fibers. The advantage is that less drug will get into the     blood circulation. Up to now, it has not been carefully studied how much of the drug appears     in the circulation after application on the skin.   "
145042|NCT01385891|"     Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able     to induce remission in resistant/refractory acute leukemias in pediatric.      Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute     Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40     mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day)     in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet     recovery (CRp) and toxicity   "
145071|NCT01385514|"     The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin and     soft tissue infections in soldiers during infantry training.      This study will be conducted on three different bases among groups of male recruits to IDF     training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two     time points: 1. before mixing and training in confined settings, reflecting carriage acquired     before entering 2. After 14-30 days. All soldiers will be under surveillance for skin     infection until the end of the training program.   "
145043|NCT01385878|"     Cataract surgical techniques have significantly changed in recent years with the widespread     adoption of smaller and smaller clear corneal incisions for phacoemulsification.     Microincision surgery has many advantages, including reduced surgically induced astigmatism,     faster visual recovery, and reduced intra and postoperative inflammation. Curently,     microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions.     However, there is still a debate as to which is the best absolute incision size for     microcoaxial cataract surgery.      The aim of this study is to evaluate incision stability following microcoaxial     phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare     intraoperative performance and postoperative outcomes following microcoaxial     phacoemulsification performed through these two incision sizes.   "
145044|NCT01385865|"     The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose     in subjects with impaired fasting glucose.   "
145045|NCT01385852|"     Understanding and modulating fluid parameters is an important, but often overlooked aspect of     phacoemulsification. In a previous study we compared the impact of using high fluid     parameters versus low fluidic parameters on real-time IOP measured during     phacoemulsification. The investigators found that using high parameters resulted in a higher     absolute rise in IOP as well as higher fluctuations in the IOP when compared to low     parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber     instability. Based on the results of this study, the investigators decided to take it further     and study the impact of using high parameters (and thus, higher chamber instability) on     macular edema and thickness following surgery, in an otherwise uncomplicated surgery.      Higher fluid parameters during phacoemulsification predisposes the eye to increased macular     thickness   "
145046|NCT01385839|"     The purpose of this study is to look at the safety, as well as the efficacy of hair     transplantation compared with irritation with hypodermic needles in the treatment of subjects     with refractory alopecia areata.      With this study, the investigators hope to demonstrate that trauma is just as effective as     hair transplant in the treatment of recalcitrant alopecia areata of the scalp.   "
145047|NCT01385826|"     The investigators propose to study the efficacy of adalimumab versus placebo (double-blind     randomization on inclusion into 2 equal groups) on reduction of ocular inflammation     quantified by laser flare photometry after two months of treatment in patients with active     uveitis despite well conducted treatment with steroid eye drops and MTX. The primary     objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus     the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2     months after inclusion, presents at least 30% reduction of inflammation on laser flare     photometry and improvement or a stable appearance on slit lamp examination. After the second     month, all patients wishing to continue the trial and presenting a satisfactory clinical     state will be treated with adalimumab for a total of one year after inclusion to     descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.   "
145048|NCT01385813|"     This is an investigation of inflammatory markers in women destined to develop preeclampsia.   "
145049|NCT01385800|"     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising     vaccine, currently being developed for the treatment of grass allergy.      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune     Grass in grass allergic subjects following challenge with with grass in an Environmental     Exposure Unit (EEU).   "
145050|NCT01385787|"     This is a non-therapeutic study. Pediatric AML patients undergoing HCT with a myeloablative     preparative regimen may be enrolled. Subjects can be enrolled 10-40 days prior to HCT. Three     samples for MRD (measured by WT1 PCR and flow cytometry) will be collected from peripheral     blood and bone marrow: 1) pre-HCT (<3 weeks prior to starting the preparative regimen), 2)     day 42 +/- 14 days post HCT (early post-engraftment), and 3) day 100 (+/-20 days) post HCT.     For two years after transplant, the subject's follow-up data will be collected using the     Research Level Forms in the CIBMTR Forms Net internet data entry system. The main objective     is to determine whether there is any association between level of pre-transplant and     post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year event-free-survival,     and to estimate the strength of that association in terms of the predictive accuracy of MRD.     The investigators hypothesize that measurable MRD at either time point will be associated     with decreased 2-year event-free survival.   "
145056|NCT01385709|"     The aim of this study is to determine whether blood levels of lithium or sertraline are     affected by different phases of the menstrual cycle and whether there is an effect on     psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and     one visit during the follicular phase of the menstrual cycle. On each visit, they will fill     out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will     be drawn to measure progesterone level and either a lithium or sertraline level, depending on     which medication the patient takes. The primary hypothesis in this study is that blood levels     of lithium and sertraline will be significantly lower in women during the luteal phase of the     menstrual cycle than during the follicular phase. Examination will also be made of whether     symptoms will increase in severity during the luteal phase as compared to the follicular     phase. The investigators expect a negative linear association between symptom severity and     blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline     decrease.   "
145057|NCT01385696|"     Preference study: Genuair vs HandiHaler inhalers in COPD patients.   "
145069|NCT01385540|"     This will be an experimental task-based functional MRI pilot study involving the neuroimaging     assessment of patients with severely bothersome tinnitus, defined by a global bothersome     scale. The investigators plan to enroll a total of 12 participants (6 severely bothered     tinnitus and 6 age-matched non-tinnitus controls) over the course of six months to undergo     task-based imaging. Subjects in the tinnitus group may have previously participated in the     CTRWU study (HRPO: 07-0689) conducted by Dr. Jay Piccirillo at Washington University and have     given permission to be contacted for consideration in future studies. The selected paradigm     will allow us to advance knowledge about the role of the attention, control, and other     cortical networks in the development and maintenance of bothersome tinnitus.   "
145058|NCT01385683|"     Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous     thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at     least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation     and the treatment of venous thromboembolism. It is administered with fixed dose and does not     require laboratory monitoring because of the low inter and intra individual pharmacokinetic     (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is     very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic     polymorphism. The inhibition of this protein can cause a significant increase in intestinal     absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major     drug interactions have been identified : quinidine (cons-indication) and amiodarone     (precautions). It is likely that other interactions exist and can be clinically significant     in patients not selected such as testing. The development of tools to study the influence of     P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic     polymorphism, the study of the latter is an important element in the detection of drug     interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to     evaluate the primary mechanism of drug interaction of dabigatran and optimize the     experimental design of studies to be conducted.   "
145059|NCT01385670|"     The objective of this study is to determine the safety, performance, and effectiveness of the     SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who     are amenable to percutaneous closure of their PFO defects.   "
145060|NCT01385657|"     The purpose of this study is to assess the safety and tolerability of repeated subcutaneous     (SC) doses of REGN668 in patients with moderate-to-severe atopic dermatitis (AD).   "
145061|NCT01385644|"     The primary objective of this study is to establish the feasibility and safety of infusions     of placental Mesenchymal Stem Cells (MSC) from related or unrelated HLA identical or HLA     mismatched donors in the treatment of Idiopathic Pulmonary Fibrosis (IPF).      The secondary objectives are to document changes in lung function, 6 minute walk distance     (6MWD), gas exchange and radiological appearance following infusion of MSC over a six month     evaluation period.   "
145062|NCT01385631|"     The purpose of the study is to examine the effect of the cholesterol lowering agent Ezetimibe     when used in addition to optimal treatment with Atorvastatin in patients with acute     ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.      An area with arteriosclerosis not demanding intervention in a coronary vessel other than the     infarct related is used as measuring point and is examined at time of the infarction and     after 12 month using intravascular ultrasound and optical coherence tomography. At the same     time the same techniques are used to examine the implanted stent.   "
145063|NCT01385618|"     Estradiol is synthesized by granulosa cells of ovaries under control of follicle-stimulating     hormone (FSH) and luteinizing hormone (LH). It is known that Estradiol plays a crucial role     in maturation and fertilization of oocytes. Furthermore it is involved in development of     secondary female sexual organs, fertility and maintenance of pregnancy.      Estradiol influences these processes by binding to estradiol receptors (ER). They are     ligand-depending transcription-factors. In humans there are two subtypes: ERa and ERb, which     are synthetized from gene ESR1 on chromosome 6 and ESR2 on chromosome 14. Both subtypes are     expressed in the ovary. Both genes are polymorph. Especially for ERa subtype several     polymorphisms and mutations are known which can be linked to breast cancer, spontaneous     abortions, osteoporosis and the point in time of menarche. Furthermore some studies have     shown a relationship between certain polymorphisms and the risk of infertility associated     gynecological malfunctions and the result of IVF treatments.      Progesterone is a hormone which plays a crucial role in initiation and maintenance of     pregnancy. It induces the transformation of the endometrium, which facilitates the     implantation of the fertilized oocyte and supports the pregnancy. Progesterone acts by     binding to its receptor. The gene for this receptor is polymorph within the population,     whereas some variants seem to account for implantation failure of embryos.      In the investigators study the investigators will analyse the role of ERP and PRP     polymorphisms in the context of IVF treatment. The analyzed genotypes are two polymorphisms     of ESRI, called Pvu and Xba, as well as a variant of ESRII, ER2. In the progesterone receptor     gene a single nucleotide exchange at position +331 (G->A) plays a role.      The parameters correlated with are concentrations of estradiol, progesterone and FSH, number     of follicles, number of fertilized oocytes and pregnancy rate.      The investigators hope to optimize established treatment protocols and to improve the chances     of success of IVF treatments depending on the genotype of the patient.   "
145064|NCT01385605|"     Environmental pollutants might be jointly responsible for increase of infertility among     women. Especially endocrin active substances seem to be of particular importance. These     substances are chemicals which interfere with the physiological system of humans and animals.     They have a negative impact on the endocrine system and disturb the functions of organs whose     hormones regulate the male and female reproductive system.      It is known that exposition to these chemicals lead to subfertility, infertility, raised     abortions, birth defects and ovarian malfunction.      Additionally it was shown that human embryos have a decreased cleavage rate after IVF when     developing from oocytes with elevated concentrations of environmental pollutants.      In this study the main focus concentrates on Nonylphenols (NP). Follicular fluids of women     with subfertility will be analyzed by a newly developed principle including HPLC and     NMR-Spectroscopy. This enables quantitative and qualitative analysis of enantiomers of NP.      The results will allow risk estimations for several endocrine active substances, especially     NP.      Additionally conclusions concerning the correlation between thes substances and subfertility     can be drawn.   "
145065|NCT01385592|"     This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's     Disease L-dopa Induced Dyskinesias (PD-LID)   "
145068|NCT01385553|"     Social service systems rarely acknowledge the status of men as fathers in the     conceptualization and delivery of treatment for substance abuse or domestic violence.     Although there has been extensive focus on the treatment of mothers who abuse substances, are     victims of intimate partner violence (IPV) (defined as physical aggression and/or     psychological abuse and control at the hands of an intimate partner), or maltreat their     children there has been little consideration of the need for interventions for fathers with     histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8     million children are witness to violence in their homes each year. National and regional     samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance     abuse have children under the age of seven. Large percentages of these men continue to live     with or have consistent contact with their young children despite aggression and substance     use.      Court mandated treatments for perpetrators of domestic violence have become the norm, however     the efficacy of these treatments is questionable and most do not speak to the broader needs     of batterers and their families. How batterer's treatments might impact parenting and     father-child relationships and the psychosocial functioning of children is vastly     understudied and not currently understood. Since batterer treatments are court mandated and     require tremendous financial and community resources, the efficacy of these interventions in     stopping the cycle of domestic violence and improving the health and well-being of the     batterer, his partner and children is crucial. There are currently NO evidence-based     treatments that address co-morbid substance abuse and domestic violence perpetration with     emphasis on paternal parenting and the father-child relationship. Consequently, the proposed     psychotherapy development project will develop and evaluate the potential efficacy of a     novel, relational parent intervention for fathers with co-morbid substance abuse and IPV who     have young children. The goals of this intervention are to decrease aggression and substance     abuse by increasing focus on fathering and an improved father-child relationship.   "
145073|NCT01385488|"     -  Breast cancer treatment-related lymphedema requires life-long self-care is required.        -  No objective measurement mechanism exists that can easily be used to self-monitor arm          volume.        -  Bioelectrical impedance devices approved for lymphedema measurement may be able to be          used for self-monitoring.        -  The investigators will conduct a two-part study to first develop an impedance driven          self-measurement protocal and then test the protocol in home settings.        -  The investigators hypothesize in part two of the study that when compared to          participants who are not self-monitoring, those who self-monitor limb volume will: 1)          report more days of garment use, skin care, and simple-MLD; and, 2) have fewer, less          distressful, less intense symptoms, better productivity/activity, report higher          perceived self-management/self-efficacy and QOL; experience fewer missed days of work,          lymphedema treatment days, arm infections, and have a smaller number of antibiotic          prescriptions.   "
145074|NCT01385475|"     The primary purpose of this study is to examine the effectiveness of the current resistance     training guidelines for older adults proposed by ACSM/AHA to improve physical function in     individuals with reduced physical abilities. A randomized controlled intervention trial will     be used to compare change in physical function pre- and post-intervention between a treatment     group receiving the minimum recommendations of the guidelines and a control group asked not     to change their physical activity participation. To better understand the clinical     significance of such an occurrence, a secondary purpose was to determine if older adults with     reduced physical abilities who adhere to the recommended intervention dosage will experience     a change such that they can be reclassified to a more favorable level of functioning. It is     hypothesized that the minimum recommended dosage of the guidelines would be sufficient to     both improve physical function and improve functional classification in older adults with     reduced physical abilities.   "
145075|NCT01385449|"     The primary hypothesis is that those patients who choose an interscalene catheter will have     less pain postoperatively than those with single injection blocks. Secondary hypotheses     examine physical therapy outcomes and incidence of parasthesia or pain following surgery for     up to 3 months.   "
145076|NCT01385436|"     Human papillomavirus (HPV) of high-risk genotype is a necessary risk factor in development of     cervical cancer. There is a vaccine available to prevent cervical lesions associated with     high-risk HPV genotypes 16 and 18. In Croatia HPV vaccination has not yet been introduced in     obligatory vaccination schedule. The aim of this study is to describe the pre-vaccination     distribution of HPV genotypes in women with high grade cervical squamous intraepithelial     lesion (HSIL) and cervical cancer in Croatia. The investigators hypothesis is that HPV-16 is     the most frequently found genotype but the distribution of other HPV genotypes is     heterogeneous and includes genotypes currently not covered by vaccination.   "
145077|NCT01385423|"     This is a single center, modified standard design dose escalation study designed to     determine the maximum tolerated, minimum efficacious dose (MTD/MED) of IL-15 (Intravenous     Recombinant Human IL-15) and incidence of donor natural killer (NK) cell expansion by day +14     when given after haploidentical donor NK cells in patients with relapse or refractory acute     myelogenous leukemia (AML).   "
145078|NCT01385410|"     This behavioural support intervention trial will investigate the potential to increase     exclusive breastfeeding rates in an urban Kenyan community through peer mother support     delivered either by cell phone or through group meetings. It will follow a cohort of more     than 800 women attending antenatal care at a large public hospital, and compare indicators of     breastfeeding and infant and maternal health between groups receiving one or other type of     peer mother support. The main part of the study will test the primary hypothesis that peer     group and cell phone based support can both increase rates of EBF at 3 months by 20% relative     to a control group.   "
145079|NCT01385397|"     Obesity is an important public health problem that is taking epidemic proportions worldwide.     Indeed, nearly 50% of Canadians are obese and their number has increased dramatically in the     last 20 years. Direct costs of obesity added to those of sedentary represent nearly 5% of the     health system's budget. Also, obesity is linked with multiple co-morbidities; furthermore,     modest weight loss has significant impact on type 2 diabetes, blood pressure and even reduces     mortality. The investigators group has implemented an interdisciplinary team that has     demonstrated its effectiveness for obesity management. However, the majority of obese     subjects should be treated by primary care physicians (PCPs) that often feel uncomfortable     when faced with the management of obesity. The investigators have therefore developed a     clinical preceptorship for PCPs; this continuing medical education (CME) activity aims at     engaging PCPs in obesity/overweight management. The current research proposal is aimed at the     development and implementation of an innovative, integrated, interdisciplinary obesity care     management system involving both primary and secondary health care professionals.      The investigators hypothesize that CME based on preceptorships in combination with electronic     tools (web site and virtual community), networking primary care (FMGs) and secondary care     health professionals, will increase the knowledge, modify attitudes and perceptions of health     care professionals and increase their sense of self-efficacy. Furthermore, this intervention     should modify health care organization regarding obesity management and eventually improve     accessibility to optimal obesity care.      The investigators will use both action (objectives 1-2) and evaluative (objectives 3-5)     research in order to attain specific objectives: 1) Develop and implement a     preceptorship-based CME complemented by a web site for physicians and nurses working in     Family Medicine Groups (FMGs). This CME will be based on needs assessment and will be     validated by one FMG using questionnaires and semi structured interviews. Also, references     and teaching tools will be available for participants on the web site. 2) Establish a     collaborative intra/inter-regional interdisciplinary network to enable on-going expertise     update and networking for FMG teams. This tool consists of a discussion forum including     exchanges about difficult cases and a monthly virtual meeting of all participants. 3)     Evaluate the implementation of this integrated system at the level of the ability to form a     number of 8 FMGs/year, access and utilization of the electronic tools and participants'     satisfaction (physicians, nurses and experts). This will be measured with the help of     questionnaires and web logging tools. Questionnaires and group interviews will also be     performed in order to evaluate participants' satisfaction. 4) Determine the impact for the     participants at the level of knowledge and expertise, attitudes and perceptions, and     self-efficacy regarding the management of obesity. Questionnaires and interviews will be used     to this purpose. 5) Deliver transferable knowledge for health professionals and     decision-makers. Strategies and pitfalls of setting up this program will be identified,     performance indicators series will be developed and accessibility to care will be evaluated     for each FMG and the 2nd line team. A knowledge transfer plan will be elaborated and applied.   "
145080|NCT01385384|"     Permanent dependency of breathing apparatus due to spinal cord injury is traditionally     treated with different types of mechanical ventilation. However, the electric ventilation     became a possibility through their most current versions, such as diaphragmatic pacemakers.      Diaphragmatic pacemakers rhythmically stimulates the diaphragm to replace the functions of     the respiratory center that doesn't works well or is inaccessible. However, this modality has     the prerequisite that the phrenic nerve and diaphragm muscle are normal. The reason for the     development of diaphragmatic pacemaker freeing the patient from the ventilator.      By using the mechanical energy of the diaphragm of the patient, the patient may come not need     the ventilator tubing, tracheostomy, and with the help of their caregivers, the inconvenient     mechanical ventilators.   "
145081|NCT01385371|"     This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243)     versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms.     Participants will receive either the sublingual grass tablet or a placebo tablet during the     study. It is expected that those participants receiving the active sublingual grass tablet     will have less hayfever symptoms and need less medications to treat hayfever symptoms during     the grass pollen season.   "
145082|NCT01385358|"     Atrial fibrillation(AF)is the commonest arrhythmia worldwide and can lead to significant     morbidity and mortality, posing an increasing public health burden. Restoration of sinus     rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with     anti-arrhythmic drugs (AAD) are poor. The alternatives to AAD are two-fold.Firstly, catheter     ablation (CA)- a technique that uses catheters (thin tubes) to deliver small 'heat lesions'     to areas of the heart to eliminate AF. Secondly, surgical ablation, where multiple incisions     are made in the atria to restore SR. Long term results from this traditional surgical     approach are excellent however as it is technically difficult open-heart procedure with     significant morbidity and mortality, it is seldom used.      CA is very effective in restoring SR in the early stages of AF when it is a paroxysmal     (intermittent) rhythm disturbance. If not treated at this stage AF inevitably evolves into a     more persistent or permanent state and becomes more difficult to treat with CA. Therefore,     the optimum approach to treat patients with symptomatic long standing persistent AF has yet     to be determined and remains a key area of on-going research.      New minimally invasive, thoracoscopically assisted surgical(closed-heart)approaches have     recently developed which ablate a wide area around the pulmonary veins, and may offer     advantages over the best current strategies in CA. There are also clear advantages for     patients with greater safety and less discomfort when compared to traditional surgical     open-heart procedures.      At present there is small amount of encouraging data on this thoracoscopic surgical technique     but there is no data comparing these two modalities of treatment in persistent AF patients.     The investigators therefore wish to prospectively investigate the safety and efficacy of this     thoracoscopic surgical technique and compare with CA in this group of patients. MRI scanning     will also be used to visualise the effects of ablation by analysis of scar formation.      The study hypothesises that thoracoscopics surgical ablation is a   "
145083|NCT01385345|"     This study will test the hypothesis that 6 months of periodic high dose Vitamin D3     replacement (200,000 and 100,000 units cholecalciferol, oral liquid drops at 6 to 8 week     intervals) followed in-between by daily 1000 units, decreases insulin resistance by HOMA2-IR     ≥ 0.36, in comparison to control, standard dose Vitamin D3 1000IU/ day for 6 months, in south     Asians with both Vitamin D deficiency (defined as 25 Hydroxy vitamin D < 25nmol/l) and     insulin resistance (defined as HOMA1 -IR≥ 1.93).      The hypothesis formed suggests that insulin resistance developed in South Asians is     explained, at least in part, by the presence of Vitamin D Deficiency (VDD). Therefore if the     VDD is reversed/ 'normalised into target range' using Vitamin D therapy in individuals at     risk of diabetes, then markers of insulin resistance should reduce from baseline values.     However, current UK recommended doses of Vitamin D do not adequately replenish severe VDD,     common in South Asians, back into the target range and therefore will not reduce insulin     resistance markers. Therefore only higher pharmacological doses are able to replace severe     Vitamin D deficiency adequately and improve insulin resistance markers.   "
145084|NCT01385332|"     The purpose of this study is to determine the efficacy and safety of two new patterns of     controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study     will be performed in egg donors but these new patterns will be implemented in fertility     preservation patients.   "
145085|NCT01385319|"     To prospectively evaluate in a multicenter open label trial whether the use of     zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high     bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac     events (MACE) including overall death, any myocardial infarction (MI) or any target vessel     revascularization (TVR).   "
145086|NCT01385306|"     The objective of this feasibility research study is to gather preliminary clinical data     regarding the safety and potential clinical benefit of noninvasive neurostimulation of the     vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to     asthma.   "
145087|NCT01385293|"     The purpose of this study is to evaluate the effects of the study drug, BKM120. The study     drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This     protein is found in normal cells and in cancer cells, but often in many cancer cells this     protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this     has not been tested yet in men with prostate cancer.   "
145088|NCT01385280|"     RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic     estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though     estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some     clinical experience indicate that it may have the opposite effect on such cells, once they     have become resistant to estrogen deprivation. In laboratory models, there is death of the     resistant population after estradiol treatment, followed by restoration of sensitivity of     the remaining cells to estrogen deprivation, as with an aromatase inhibitor. Exemestane may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     therapeutic estradiol together with exemestane may kill more tumor cells.      PURPOSE: This clinical trial studies therapeutic estradiol and exemestane in treating     post-menopausal patients with hormone receptor-positive metastatic breast cancer   "
145090|NCT01385254|"     The proposed study will explore longitudinally the impact of a very low birthweight (VLBW)     infant on mother-sibling interactions and sibling adjustment. The study will also include a     comparison group of fullterm infants to determine which sibling adjustment problems are     typical of having a new baby in the home and which are associated with the unique stress of     having a VLBW infant. This study will be the initial step in identifying factors affecting     the adjustment of siblings of VLBW infants.   "
145091|NCT01385241|"     The purpose of this study is to test the feasibility of a stigma reduction intervention in     Human Immunodeficiency Virus(HIV)-positive women using a video of first-person narratives     delivered via personal Ipod Touch.   "
145092|NCT01385228|"     The primary purpose is to define the safety and tolerability of docetaxel/prednisone in     combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer     (mCRPC).   "
145093|NCT01385215|"     The purpose of this study is to determine the safety and effectiveness of the influenza     vaccine when administered nasally and intra-muscular (a shot of medicine given into a     muscle). The investigators will measure the systemic (through out the body) and mucosal     immune responses (how your body recognizes and defends itself against bacteria) to nasally     administered influenza vaccine, and determine if nasal immunization results in immunity (your     body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral     and reproductive), in comparison with intramuscular administration and placebo (inactive     substance given in the same form as the active drug).   "
145094|NCT01385202|"     The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL®     SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug     refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology     mapping and RF procedures.   "
145095|NCT01385189|"     This study is designed to evaluate the safety, reactogenicity, and immunogenicity of Na-GST-1     adsorbed to Alhydrogel® with or without two different dose concentrations of a novel     adjuvant, GLA-AF (1 µg or 5 μg) among healthy adult volunteers.   "
145096|NCT01385176|"     The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve     stimulation in heart failure patients with a New York Heart Association Class III, an     ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than     130 ms.   "
145122|NCT01384838|"     This randomized trial aims to assess if a well defined subgroup of breast cancer patients     benefit from a controlled physical activity program.      All patients will be screened for their physical ability to complete the interventional     exercise program. Only patients capable and willing to take part in this study and meeting     all inclusion and exclusion criteria will be randomized.      All patients are to receive identical counseling for ideal nutritional, life-style and     physical activity.      Patients randomized to Arm 2 will additionally undergo a controlled and observed program of     physical activity for a period of 6 months. Thereafter the patients are expected to adhere to     a comparable, unobserved exercise program at home.   "
145097|NCT01385163|"     The Democratic Republic of the Congo (DRC) has become synonymous with sexual violence by     armed groups within the last 2 decades. Reportedly, tens of thousands of women and girls have     been raped, sexually assaulted, attacked and abducted in the Eastern Provinces including     North and South Kivu, targeted by armed groups with unparalleled levels of brutality.      Access to services in North and South Kivu—both emergency and longer term care—remains a     major challenge. Limited services as well as the potential stigma of seeking services mean     that many survivors have never received adequate care. Results of a preliminary study found     many survivors have substantially reduced ability to function, including reduced ability to     perform basic tasks and activities related to earning, self care, caring for family, and     contributing to their communities. These survivors also describe high rates of mental health     and social problems including mood disorders, anxiety, withdrawal, and stigmatization and     rejection by family and community.      While social and economic development in conflict affected areas like DRC relies on     populations who are ready and able to work, the psychological effects of conflict may mean     that a percentage of the population living in these low-resource areas are less able to     engage in economic opportunities even when they are available. However, there is little data     on the best strategy to deal with this.      This study will be run as two parallel randomized impact evaluations to investigate the     impacts of two different intervention programs to be implemented as part of standard     programming of the collaborating NGO. The first study will focus on the impact of IRC's     social-economic intervention, Village Savings and Loans Associations (VSLA) compared to a     wait-control sample. The VSLA impact evaluation study will be conducted in communities served     by 9 community-based organization (CBO) partners. The second study will focus on the impact     of a mental health intervention, Cognitive Processing Therapy (CPT) compared to a     wait-control sample. The CPT impact evaluation study will be conducted in communities     serviced by NGO partners currently providing psychosocial support. As an exploratory     investigation, the researchers will follow the CPT program with the VSLA program to look at     the effect of receiving a mental health intervention prior to the VSLA on rates of retention     and impact.   "
145098|NCT01385150|"     RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help     doctors identify and lean more about biomarkers related to cancer.      PURPOSE: This research study is studying biomarkers in blood samples from patients with acute     myeloid leukemia.   "
145099|NCT01385137|"     RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and     bone pain and stiffness caused by hormone therapy in patients with breast cancer.      PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in     treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III     breast cancer receiving hormone therapy.   "
145100|NCT01385124|"     Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing     allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence     of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical     sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated     transplants. More effective prevention and treatment strategies are needed.      The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in     animal models of various inflammatory diseases including multiple sclerosis, inflammatory     bowel disease and rheumatoid arthritis.      Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and     immunosuppressive effects.      As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell     transplantation.   "
145101|NCT01385111|"     This study aims to investigate a diagnostic yield and performance characteristics according     to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA)     and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration     (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a     better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in     a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform     EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first     applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic     yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the     EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate     diagnostic yields and performance characteristics of each group.   "
145117|NCT01384903|"     The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to     plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative     method in patients with Disseminated Intravascular Coagulation (DIC) associated with     infection.   "
145102|NCT01385098|"     As the use of bariatric surgery for treatment of extreme obesity adults continues to rise,     clinicians must be aware of pre-existing nutritional deficiencies in overweight and obese     patients. Nutritional deficiencies are common in patients undergoing bariatric surgery and     these deficiencies should be detected and addressed early to avoid post-operative     complications. To improve long-term outcomes following bariatric surgery, nutritional     screening and prescribing appropriate supplementation to prevent nutrient deficiencies is     needed. Vitamin D deficiency is common following bariatric surgery and has been reported to     occur in 50-80% bariatric patients.The goal of this pilot study is to help develop nutrient     supplementation interventions following two types of bariatric surgery: Roux-en Y gastric     bypass and sleeve gastrectomy.      Recently, several studies in adults have revealed an inverse relationship between body fat     and blood 25-hydroxyvitamin D3 [25(OH)D] levels, the relevant marker of low vitamin D status.     Although vitamin D is well known for its essential role in bone metabolism and calcium     homeostasis, increasing evidence is linking vitamin D to obesity. This study will evaluate     vitamin D status during post operative daily supplementation of 2,000 IU of vitamin D3 and     1500 mg of calcium through assessment of changes in serum 25(OH)D, parathyroid hormone (PTH),     calcium and phosphorus at baseline, 4 weeks, and 12 weeks following surgery. The dietary     contribution of vitamin D and calcium will be estimated by food records analyzed using the     University of Minnesota 2010 Nutrition Data System for Research (NDSR) program.      Primary Hypothesis: Daily supplementation with 2,000 IU of vitamin D3 for 12 weeks will     significantly increase mean serum 25(OH)D levels in obese subjects following bariatric     surgery compared to baseline levels.      Secondary Hypothesis: The percent response above baseline to daily supplementation with 2,000     IU of vitamin D3 will significantly differ between Roux-en Y and sleeve gastrectomy patients.   "
145103|NCT01385085|"     Three types of workers exposed to different levels of natural sunlight will be tested for     Vitamin D blood level, PTH, Ca, P, albumin and alkaline phosphatase.      In addition, each tested worker will be asked to fill a questionnaire for demographic,     medical and personal habit information.   "
145104|NCT01385072|"     Patients with active acute leukemia have dismal prognoses even with allogeneic     transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse     rates are needed.      Relapse risk after double umbilical cord transplantations have been shown to be significantly     lower compared to matched sibling and matched unrelated donor transplantations due to better     graft versus leukemia effect.      The investigators hypothesize, that concomitant transplantation from 2 matched siblings may     improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and     other high risk hematological malignancies.   "
145105|NCT01385059|"     This randomized phase II trial studies how well axitinib works in treating patients with     high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor     cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery     may make the tumor smaller and reduce the amount of normal cells that have to be removed   "
145106|NCT01385046|"     Project FIT is a collaboration between the public school system, local health systems,     physicians, neighborhood associations, businesses, faith-based leaders, community agencies     and university researchers to develop a multi-faceted approach to promote physical activity     and healthy eating toward the general goal of preventing and reducing childhood obesity among     children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school,     community, social marketing, and school staff wellness - all that focus on: 1) increasing     access to safe and affordable physical activity and nutrition education opportunities in the     schools and surrounding neighborhoods; 2) improving the affordability and availability of     nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge,     self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school     staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to     incorporate healthful values; and 5) encouraging dialogue among all community partners to     leverage existing programs and introduce new ones.   "
145107|NCT01385033|"     The purpose of this study is to evaluate radiolabeled [18F]MK-3328 as a PET tracer for     estimating the regional distribution and extent of amyloid plaques in participants suffering     from amnestic mild cognitive impairment (aMCI) and Alzheimer's Disease (AD) versus healthy     young and elderly participants. The study hypotheses will test whether [18F]MK-3328 can     discriminate between AD participants and cognitively normal elderly control participants as     measured by brain regional tracer uptake.   "
145108|NCT01385020|"     Red yeast rice capsule (LipoCol Forte)is a nature product that has been demonstrated a     significant cholesterol lowering effect which might be caused by addictive and/or synergistic     effects of lovastatin (monacolin K) with other monacolins and substances in capsules. The     usual dose of red yeast rice capsule(LipoCol Forte)for hypercholesterolemia is one capsule     twice/day.      Gemfibrozil is a fibric acid derivative (fibrate). It can reduce the levels of triglycerides     and increase the levels of high-density lipoprotein cholesterol (HDL-C). Patients with mixed     lipid disorders may therefore benefit from a combination of a statin and a fibrate. Although     the combination of a fibrate and a statin is highly effective,concerns about an increased     incidence of myopathy and even rhabdomyolysis have limited the widespread use of such     combinations. Such combination therapies are prone to drug-drug interactions, which can lead     to altered pharmacokinetic profiles of either drug, an effect observed for many statins in     combination with fibrates. However, the drug-drug interactions have not been reported between     red yeast rice capsule and gemfibrozil.      The objective of the study is to evaluate the effect of gemfibrozil on the plasma     concentrations of lovastatin and its active form, lovastatin acid, from red yeast rice     capsule in healthy volunteers. In addition, the investigators also measure the plasma     concentration of creatine kinase (CK) and co-enzyme Q10 for safety assessment.   "
145118|NCT01384890|"     This will be a prospective longitudinal study describing clinical throughput metrics and     patient reported quality of life outcome measures for patients undergoing Volumetric     modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head     and neck carcinoma at the British Columbia Cancer Agency.        1. VMAT for the treatment of patients with HNC will provide opportunities for image-guided          radiotherapy using CBCT online correction to reduce systematic and random error.        2. Analysis of patient reported quality of life outcomes during VMAT, with and without CBCT          acquisition, will be hypothesis generating.   "
145119|NCT01384877|"     This study's primary objective is to test the hypothesis that a single infusion of     subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48 hours     of infusion and lasting a minimum of 7 days. Subjects will receive either lidocaine or     placebo, followed at least 3 weeks later by the alternate agent.   "
145298|NCT01382550|"     The aim of this study is to estimate the incidence of spontaneous and provoked recurrent VTE     and the bleeding events during a 10-year follow-up in subjects experiencing a first VTE     stratified according to % AT levels and to treatment schedule (long-term vs 6-12 months oral     anticoagulation+transient prophylaxis during high risk periods)   "
145109|NCT01385007|"     Aggression, a common symptom in persons with dementia, is linked with multiple treatable     etiologies such as pain, depression, caregiver burden, and caregiver relationships. Pain, the     main predictor of aggression, is a common symptom that is inadequately assessed and treated     in persons with dementia. The main treatment for aggression is antipsychotic medications that     are ineffective, costly, and possess considerable adverse side effects. There is a need to     test psychosocial interventions that address treatable causes of aggression. Preliminary data     suggest the potential utility of Preventing Aggression in Veterans with Dementia (PAVeD), an     evidence-based psychoeducational intervention aimed to prevent aggression, with urban     dwelling Veterans. PAVeD, an in-home intervention that requires significant clinician time     and expense has yet to be evaluated in a rural culture with Veterans who are in poorer health     compared to urban Veterans.      The purpose of this intervention demonstration pilot study is to pilot test and evaluate the     PAVeD-Telephone intervention. Twenty rural Veterans with dementia and pain and their     caregivers from the Home Based Primary Care (HBPC) Program will be invited to participate.     Clinical activities directed toward caregivers are supported by policies and procedures set     forth by the Veterans Health Administration (Appendix A). Mixed-methods will be used to     collect data using semi-structured interviews and standardized data collection measures     suitable for persons with dementia and their caregivers. The interviews go beyond an     evaluation of the outcomes by exploring how the intervention was experienced by the dyad.      The specific aims of the study are to:        1. Describe the feasibility and acceptability of the PAVeD-Telephone intervention (number          of dyads recruited and completing the study) by rural Veterans and their caregivers.        2. Describe the preliminary outcomes (aggression, depression, Veteran/caregiver          relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6          months.        3. Understand the cultural beliefs and practices of this population and the impact of the          intervention.      The PAVeD-Telephone intervention is an innovative approach to shift the paradigm of treating     aggression with antipsychotic medications. This study is consistent with the goals of the     South Central Mental Illness Research Education and Clinical Center (MIRECC) to improve     evidence-based practices in rural Veterans and their caregivers. The next step in this     program of research is to submit a Health Services Research and Development Service (HSR&D)     application for pilot funding to further develop and test the telephone-based intervention     and an appropriate control condition.   "
145129|NCT01384747|"     -  Fimasartan will be more beneficial in stabilizing the plaque vulnerability compared to          control group in deferred coronary lesions.        -  Fimasartan will be more beneficial in reducing total plaque volume compared to control          group in deferred coronary lesions.        -  Fimasartan will be more beneficial in reducing functional impairment of stenotic lesions          (assessed by FFR:Fractional Flow Reserve) in deferred coronary lesions.   "
145130|NCT01384734|"     The purpose of this study is to assess the safety, efficacy, tolerability and     pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil     Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well     tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1     infected subjects.   "
145706|NCT01377194|"     The purpose of this study is to evaluate the efficacy, safety, and tolerability of     Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).   "
145110|NCT01384994|"     Up to 50% of patients with colorectal cancer (CRC) develop liver metastasis during the course     of their disease. In 30-40% of patients metastasis is confined to the liver. In these     patients R0-resection of metastases may contribute to marked improvement of overall survival.     Primary resection of liver metastasis is possible in about 15-20% of patients (Scheele 2005,     Petrelli 2005). Recent studies indicate that perioperative chemotherapy may improve survival     after resection of liver metastases (Portier 2007, Nordlinger 2007). Nevertheless, there is     evidence that 70-80% of patients have recurrent disease after resection of liver metastasis.     Stratification for the risk of recurrence may be performed using the FONG-score (Fong 1999).      This study is designed to investigate the efficacy of postoperative chemotherapy combined     with an anti-EGFR treatment using panitumumab.      The majority of patients present to the surgeon after chemotherapeutic pretreatment with     various not necessarily standardized regimens. Also postoperative therapy after resection of     liver metastasis is not a clearly defined standard of care in Germany.      Based on the study by Nordlinger et al. an oxaliplatin-based regimen is chosen for     postoperative therapy (Nordlinger 2008). For reasons of practicability mFOLFOX6 was selected     as the chemotherapy backbone for additive treatment (Allegra 2010).      Also, there is evidence that the combination of FOLFOX with panitumumab is associated with     enhanced antitumor activity (Douillard et al. ESMO 2009). The experimental treatment arm will     therefore evaluate the combination of FOLFOX plus panitumumab. Since in colorectal cancer     monoclonal antibodies directed against the EGFR are not active in KRAS mutant patients, the     experimental arm including panitumumab will only be performed in KRAS wild-type patients     (Amado 2008).      The planned study aims to assess the efficacy of postoperative therapy with FOLFOX plus     panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type patients,     compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by     a randomised control group without the antibody. (Figure 1: Study Design).      The study will allow preoperative treatment with regimens such as FOLFIRI, XELIRI, FOLFOX or     XELOX +/-bevacizumab or +/- cetuximab. However, only those patients will be considered     eligible who did not progress during preoperative therapy.      After surgery, a treatment-free interval of at least 4 weeks, but no longer than 8 weeks will     be granted.      KRAS-wild-type patients (60% of all pts) will then be randomized in a 2:1 ratio to an     experimental arm with FOLFOX + panitumumab or to a reference arm with FOLFOX alone.     Combination treatment will be performed for a duration of 3 months, after which patients in     the experimental arm will receive maintenance therapy with panitumumab for further 3 months.     In the reference arm, treatment will, however, be ended after 3 months.   "
145111|NCT01384981|"     The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary     rehabilitation increases exercise capacity and quality of life more than pulmonary     rehabilitation alone.   "
145112|NCT01384968|"     Six days of dietary nitrate (NO3-) supplementation in the form of beetroot juice (~0.5 L•d-1;     5.1-11.2 mmol NO3- •d-1) has been purported to reduce pulmonary oxygen uptake (VO2) during     submaximal exercise and increase tolerance to high-intensity workloads. These results suggest     that dietary nitrate supplementation has the potential to act as an ergogenic aid. Recently,     we assessed submaximal oxygen uptake and 10 km time trial performance after 6 d of dietary     nitrate supplementation in trained cyclists. We demonstrated an improvement in time trial     performance compared to the nitrate-depleted placebo. However, the minimal dosage and     duration of nitrate supplementation that is needed to elicit these performance effects remain     largely unknown. Therefore, the purpose of the study is to assess performance capacity     following an acute dose of nitrate supplementation consumed 3 h prior to the onset of     exercise in trained cyclists. We will test the hypothesis that a single dose (140 mL; ~8 mmol     NO3-) of dietary nitrate supplementation in the form of beetroot juice, ingested 3 h prior to     exercise will improve time trial performance in trained cyclists compared to a     nitrate-depleted placebo.   "
145113|NCT01384955|"     We attempt to investigate the influence of physiotherapy and physical activity education     applied in adolescence on physical fitness, curve progression, pulmonary function, physical     activity and quality of life in adulthood. Quality of life assessment includes mental and     social functioning, body image, self - esteem, depression and anxiety surveillance. The     follow - up period ranges from 15 to 26 years. Also a group of shorter follow - up of 9 - 13     years is available.      The null hypothesis is that scoliosis specific exercise program applied in adolescence does     not influence HRQoL and functioning in adulthood.   "
145114|NCT01384942|"     Given that individuals in bereavement tend to experience substantial psychological distress     in the first two years following loss, individuals seeking psychological support will need     appropriate services grounded in sound empirical scholarship. There is a lack of studies     assessing bereavement groups, despite groups being one of the most common forms by which such     services are offered. The prominent and emerging process of meaning-reconstruction in     bereavement research is theorized to lead to better psychological adjustment and prevent more     prolonged grief reactions. The principal objective of this study is to compare two types of     group counseling for individuals in bereavement: A novel meaning-based bereavement counseling     group and a conventional bereavement support group.   "
145115|NCT01384929|"     There is scant data on the casemix and practices in Indian intensive care units (ICUs). Most     of the available data comes from single centre studies. There is a dire need to have data     from Indian ICUs to reflect the vast spectrum of critical care illness, services and     practices. INDICAPS planned to collect data of all patients in the ICU on one particular day,     and four such days spread throughout a one-year period were selected: the second Wednesday of     July and October this year, i.e. July 14 and October 13, 2010 and the second Wednesday of     January and April next year, i.e. January 12 and April 13, 2011. As many ICUs all over the     country as possible were asked to participate. The investigators aimed to gather information     about ICUs, patients in ICUs, the types and severity of illness, monitoring and therapeutic     modalities used, types of infections,mortality rates, etc.   "
145116|NCT01384916|"     The purpose of the study is to investigate whether yoga or a health education group alleviate     depressive symptoms for an individual with a partial response to antidepressant medication.   "
145120|NCT01384864|"     The overall objective of this pilot study is to determine whether multispectral imaging     increases the diagnostic accuracy of the current standard of high-definition white-light     endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or     cancer). The investigators goal is to develop a multispectral endoscopic platform that can be     used to survey a large surface area and, potentially, serve as a 'red flag' for     microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily     determine the accuracy of these modalities during the endoscopic surveillance of Barrett's     esophagus.   "
145121|NCT01384851|"     The purpose of this study is to determine the therapeutic effect of the chronic application     of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition     of environmental stress. The effect will be studied in terms of changes in tear physiology     and the inflammatory biomarkers on the ocular surface.   "
145131|NCT01384721|"     The study aims at pooling a large population of patients with suspected coronary artery     disease (CAD) who underwent Computed Tomography Coronary Angiography (CTCA) and who were     adequately stratified in the first place. Then the investigators will be able to assess the     incremental value of CTCA in the stratification of prevalence of disease (non     obstructive/obstructive) and prognosis of patients with suspected CAD). The added information     to current evidence is how reliable and to what extent CTCA can define the actual burden of     disease and cardiovascular risk.   "
145123|NCT01384825|"     The presence of abnormalities in the cerebral venous circulation, defined as Chronic     Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with     Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological     diseases. These reports have aroused much interest both in the scientific world and, above     all, among the communities of patients and Associations having the aim of aiding people with     MS and of promoting scientific research into this disease.      In the literature published so far there is a lack of verification in large samples of the     prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with     other diseases of the nervous system.      This is an observational study investigating the prevalence of CCSVI in subjects with MS and     comparing it with the prevalence observed in a control population consisting of Healthy     Controls (HC) and in a population affected by other neurological diseases of the central     nervous system of degenerative, vascular, inflammatory and autoimmune origin.      A total of at least 1,200 adults with MS will be included in the study, as well as 400     healthy subjects and 400 subjects with other neurodegenerative diseases.   "
145124|NCT01384812|"     The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation     of brain vessels in migraine patients without aura.   "
145125|NCT01384799|"     This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin     and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a     multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human     epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is     designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101     when administered in combination with concurrent cisplatin and radiation over an 8-week     treatment course, consisting of a one week run-in period of CUDC-101 administered alone,     followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation     therapy.   "
145126|NCT01384786|"     Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan     before they are treated with radioiodine for their thyroid disease. Because the investigators     do not get a histologically/final diagnosis the investigators want to make sure, that the     patients treated do not have a thyroid cancer when treated.      The investigators have found that thyroid cancer is not overlooked.   "
145127|NCT01384773|"     Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and     post surgical ectasia is an iatrogenic condition. These diseases are characterized by     weakening of the front part of the eye that causes thinning and distortion. This distortion     results in unevenness of the cornea and produces progressive near-sightedness and     irregularity, which causes loss of vision when using eyeglasses. When eyeglasses fail to give     enough vision, the the investigators use rigid contact lenses to create an artificial front     eye surface. This improves visual acuity in many patients although they eventually fail     either because they cannot be tolerated or the surface irregularity has become so severe that     they are rejected. At this stage there is usually thinning and loss of clarity of the eye.      There has been no treatment for this other than corneal transplantation, a complex surgical     procedure with a significant complication rate and a delay in visual recovery. The treatment     the investigators wish to perform strengthens the front of the eye by a chemical reaction     using light and riboflavin. This technique has been studied over a decade and is widely used     throughout the world. The FDA approved multicenter American clinical study is being analyzed     in anticipation of its submission to the FDA for PreMarket approval. Because this is a     progressive condition, the investigators wish to be able to offer this on a limited basis to     patients in need with vision loss.      Any treatment that can delay or prevent corneal transplantation is of great benefit. The     investigators believe the evidence is compelling that this treatment is the sole alternative     to surgical transplantation.   "
145138|NCT01384630|"     This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in     subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of     RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42     for a total of 3 injections. Study drug will be administered under close observation in a     facility equipped to handle medical emergencies. Subjects will not be discharged from the     facility until at least 1 hour following the end of the injection or 1 hour after their vital     signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements     of vital signs, clinical laboratory assessments, and the recording of adverse clinical     events.   "
145139|NCT01384617|"     The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases     pancreatic fistula following distal pancreatectomy, compared with stapling closure of the     pancreatic stump.   "
145128|NCT01384760|"     Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB)     characterized by repetitive episodes of cessation of breathing during sleep due to upper     airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired     cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal     and fatal cardiovascular consequences including sudden death, in addition to an increased     risk of road traffic accidents. Continuous positive airway pressure (CPAP) is considered as     the first-line treatment for OSA. Oral appliance has been shown to reduce the severity of     sleep disordered breathing and leads to symptomatic improvement especially in mild to     moderate OSA. The compliance with CPAP is low particularly in mild or moderate OSA patients     and it is not a curative treatment of OSA. It has to be used in every night on a regular     basis. Weight reduction has always been advocated in patients with OSA who are overweight and     may lead to improvement in the severity of OSA. The existing studies about weight loss are     limited by small sample size, short duration (<6 months), focus on very low calorie diet     program or surgically induced weight loss program only. However, none of them have applied     lifestyle modification program (LMP) which emphasizes on long term lifestyle and behavior     change. Therefore, the investigators plan to conduct a randomized controlled trial among     Chinese OSA patients by comparing the efficacy of LMP against usual clinical lifestyle advice     alone on the improvement of OSA symptoms.   "
145157|NCT01384383|"     This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral     efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451     + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in     treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC     genotype.   "
145132|NCT01384708|"     The overall objective of this study is to determine whether high-resolution imaging of the     esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and     discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME)     was developed by our collaborators at Rice University and provides > 1000x magnified images     of the esophageal mucosa. The purpose of this study is to determine whether this device can     be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell     cancer of the esophagus.   "
145133|NCT01384695|"     The overall objective of this study is to obtain data to evaluate whether high-resolution     imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic     (precancerous) areas. This is an exploratory study of a confocal endoscope designed to     evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of     subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope     provides real-time in vivo microscopic images of the mucosa which resemble standard     pathology.   "
145134|NCT01384682|"     MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients     who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will     be randomized (1:2:2) to one of three treatment groups: to continue their current treatment     regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily     with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic     assessment of tropism cannot be used to determine tropism, instead we will employ the     genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim     of this study is to investigate whether switching to maraviroc, in combination with either     RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI     with PI/r. The other aim is to see if switching to these combinations with maraviroc will     improve some of the side effects that can be seen when people take combination therapy     including RTI and PI/r.      The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200     copies/mL) patients with no history of prior virological failure, a switch to either MVC     dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC     dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the     investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral     efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.   "
145135|NCT01384669|"     In this study, the investigators look at the genetic expressional alteration which influenced     on the early lateral neck node metastasis in thyroid papillary microcarcinoma.   "
145136|NCT01384656|"     Patients undergoing multivessel off-pump coronary bypass surgery (OPCAB) inevitably     experience cumulative ischemia-reperfusion injury at myocardium. Glucose-insulin-potassium     (GIK) is a potentially useful adjunct to myocardial protection. This study was designed to     evaluate the effects of GIK infusion on myocardium in patients undergoing OPCAB. Patients     undergoing OPCAB with acute coronary syndrome are randomly assigned to GIK or Control group.     The trial is double-blind and conducted at a single center.   "
145137|NCT01384643|"     Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting     patient outcome following cardiovascular surgeries. Propofol, an intravenously administered     anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to     investigate the ability of propofol to protect kidneys against I/R injury in the patients     undergoing valvular heart surgery.   "
145175|NCT01384149|"     The purpose of this study is to evaluate the advantages and disadvantages of external     selective laser trabeculoplasty (SLT) in treating open angle glaucoma,compared to traditional     SLT.   "
145140|NCT01384604|"     The overall goal of this project is to identify intermediate phenotypes for psychosis across     the schizophrenia and bipolar disorders boundary with implications for future genetic     studies. Recent studies provide considerable evidence that schizophrenia and psychotic     bipolar disorder may share overlapping etiologic determinants. Identifying disease-related     genetic effects is a major focus in schizophrenia and bipolar research, with enormous     implications for diagnosis and treatment for these two disorders. Efforts have been     multifaceted, with the ultimate goal of describing causal paths from specific genetic     variants, to changes in neuronal functioning, to altered brain anatomy, to behavioral and     functional impairments. Parallel efforts have identified and refined several alternative     endophenotypes that are stable, heritable, have (partly) known biological substrates, and are     associated with psychosis liability. Although many such endophenotypes have been individually     studied in schizophrenia, and to a lesser extent in bipolar disorder, no study has     comprehensively assessed a broad panel of these markers in the two disorders with parallel     recruitment, and the extent to which they mark independent aspects of psychosis risk, or     their overlap in the two disorders. In this research project, we will examine a broad panel     of putative endophenotypes in affected individuals and their first degree, biological     relatives in order to: 1) characterize the degree of familial phenotypic overlap between     schizophrenia and psychotic bipolar disorders; 2) identify patterns of endophenotypes unique     to the two disorders; and, 3) contrast the heritability of endophenotypes across the     disorders. We will obtain measures of neurophysiology (e.g., eye tracking, P50 gating, PPI,     and P300), neurocognition (e.g., attention/vigilance, episodic and working memory), and brain     structure (e.g., volumes of gray and white matter in specified brain regions). Blood samples     will also be collected and stored for formal DNA linkage analyses using the independent     phenotypes identified above. All volunteers will also be given the option to donate dermal     biopsies for future research studies.      Establishing similarities and differences in the endophenotypic signatures within     schizophrenia and bipolar families will provide important insights for future genetic     studies, and clarify concepts about common and distinct aspects of pathophysiology,     potentially meaningful heterogeneity with disorders, and the clinical boundaries of the two     most common psychotic disorders in adult psychiatry. This line of investigation will     potentially impact our conceptualization of psychotic disorders, help us make critical     strides to identify the pathophysiology of psychosis, and guide development of new specific     treatments targeting particular deficits.   "
145151|NCT01384461|"     This observational study will evaluate the safety, tolerability and efficacy of     RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to     severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on     treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate     (weekly dose at the discretion of the physician).   "
145152|NCT01384448|"     The purpose of this study is to determine whether stress echocardiography or computed     tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to     select appropriate candidates for hospitalization and further work-up.   "
145153|NCT01384435|"     The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to     placebo in patients with Spinocerebellar Degeneration (SCD).   "
145154|NCT01384422|"     -  Thirty six patients suffering from active rheumatoid arthritis despite continued          treatment with methotrexate will be evaluated for improvement of disease activity when          taking GLPG0634 or matching placebo for 4 weeks.        -  During the course of the study, patients will also be examined for any side effects that          may occur, and the amount of GLPG0634 present in the blood as well as the effects of          GLPG0634 on disease- and mechanism of action-related parameters in the blood will be          determined.   "
145141|NCT01384591|"     The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and     impaired capacity for building of muscles. In aging populations, this decreased ability to     build muscles may represent a tipping point in the progression towards chronic physical     frailty and disability. The goal is to examine whether novel pharmacologic therapies can     improve nutritive blood flow to the muscles and muscle building in the elderly.      The purpose of this study is 1) to determine if losartan administration will enhance the     building of muscles via proteins and suppress muscle breakdown 2) to determine if     N-acetylcysteine (NAC) will enhance blood flow to muscles and the building of muscles via     proteins.      The investigators will study community dwelling, healthy older men and women (60-85 years).     Subjects will be randomized to one of three groups:      Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group     2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3:     N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo      Subjects will admit the night before and get their first dose of NAC/ losartan/ placebo with     dinner. Subjects will be fasted after 10 pm. The next morning at 6 am blood samples will be     taken and leg blood flow (LBF) will be measured. Subjects will receive their second dose of     NAC/ losartan/ placebo. As from 6 am every hour blood will be drawn until 1 pm. At 8am, the     second biopsy is taken and LFB and CEU will be measured. At 11am they get their third dose of     NAC/ losartan/ placebo together with leucine (oral) and again a muscle biopsy is taken and     LBF is measured. Leucine is anabolic to skeletal muscle of elderly and so the investigators     will use it to stimulate muscle building.   "
145142|NCT01384578|"     120 patients of biopsy proven NASH will be randomized into two groups. Cases group will     receive combination of pentoxiphylline and Vitamin E, and control group will receive only     Vitamin E.   "
145143|NCT01384565|"     Study Design      50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I B)      Investigations:      Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver function     testing, AFP Kidney function testing Etiology of chronic liver disease Infectious etiology:     total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune markers, copper     studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal bleed Infection (     blood culture, urine culture, sputum culture, chest xray) Surgery Drugs Alcohol intake     Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis     CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing Histology ( by     transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD 54, CD 123, BDCA 2     staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells measurement in     hepatic venous blood, peripheral blood and liver biopsy by flow cytometry Markers of     proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver biopsy Markers     of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of Hepatic venous     pressure gradient ( HVPG)   "
145144|NCT01384552|"     The objective of this study is to determine the independent and combined effects of weight     status and the level of dietary restraint on the relationship between package unit size and     food intake.   "
145145|NCT01384539|"     The purpose of this study is to determine whether nutritional (cholecalciferol) or active     vitamin D (calcitriol) supplementation improves vascular endothelial function in patients     with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The     investigators hypothesize that the use of calcitriol supplementation will result in improved     vascular endothelial function as compared to cholecalciferol supplementation.   "
145146|NCT01384526|"     Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal     women receiving treatment for early stage breast cancer. However, the impact of long-term     endocrine therapy on ovarian function is not established, and to our knowledge, has never     been directly studied. Understanding the effects of hormone therapy on ovarian aging will     help breast cancer patients of reproductive age make more informed and empowered decisions     regarding their treatment. The purpose of this study is to explore the relationship between     tamoxifen therapy and ovarian aging. Patients will be identified through the UCSF Cancer     Registry and California Pacific Medical Center Cancer Registry and will be evaluated based on     age and menopausal status. Women who read about the study from clinicaltrials.gov and contact     the study coordinator will also be considered for enrollment. The age of menopause onset will     be assessed through surveys and will be compared to the accepted national average age of     natural menopause. Biomarkers of ovarian reserve will be assessed in premenopausal women     between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched     premenopausal controls from an ongoing RO1- funded prospective longitudinal ovarian aging     (OVA) study.   "
145147|NCT01384513|"     The purpose of this research study is to compare the survival rates of patients with better     risk disease undergoing hematopoietic stem cell transplant (HSCT) to the survival rates     reported in the medical literature of similar patients undergoing reduced intensity HSCT from     matched related donors.   "
145148|NCT01384500|"     Patients who are intubated (breathing tube in windpipe) are often transported by air     ambulance. Changes in atmospheric pressure during flight may cause pressure increases in the     air-filled cuff holding the tube in the windpipe. Studies show that more than half the     patients had potentially harmful pressures in the cuff during flight. High pressures lead to     complications, such as injury to the windpipe. To avoid injury, cuff pressures must be kept     at a safe level. There are many ways to avoid unsafe cuff pressures. One is to inflate the     cuff with sterile fluid instead of air. Fluids are not subject to changes in atmospheric     pressure. Using fluid, instead of air, in the cuff causes less pressure increases and less     windpipe injury. The use and safety profile of this during transport by air ambulance has not     been studied. This study compares tracheal tube cuff pressures, filled with air or fluid, at     routine flying altitudes during patient transports by air ambulance.   "
145149|NCT01384487|"     The primary objective of this clinical study is to compare the Nidek RS-3000 Optical     Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to     evaluate any adverse events found during the clinical study.   "
145150|NCT01384474|"     This multicenter cluster-randomized trial will evaluate the impact of Crew Resource     Management training on the occurrence of postoperative complications and the adherence to a     surgical safety checklist, among a large sample of French surgical departments.   "
145158|NCT01384370|"     In both the ASC-US Study and Adjunct Study populations, the objectives are to:        -  evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical          disease in women with APTIMA HPV Assay positive results and        -  evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45          in women with APTIMA HPV Assay positive results.   "
145159|NCT01384357|"     The objective of the present study was to compare ultrasound (US) characteristics and     ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA)     in the assessment of different malignant cervical lymphadenopathies. Patients with malignant     cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to     2010 Dec were retrospectively reviewed. There are two major study groups according to the     treatment status of the patient's population, including patients who had pathology proofed     previous cancer and with clinically cervical lymphadenopathies after treatment. The second     group included patients with cervical lymphaenopathies but without previous diagnosis of     malignancy and treatment. The results of cytology, or pathology and time of needle biopsy to     final diagnosis were traced and recorded. Morphologic US parameters and vascular features     were thoroughly evaluated and compared in different disease.   "
145160|NCT01384344|"     Cognitive and memory disorders are characterized of Alzheimer disease. In addition,     psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents     and play an important role in prognostic and intervention. These symptoms are noticed before     the diagnostic of dementia, their prevalence and their intensity increase with the evolution     of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent     of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest, initiative     and blunting emotional are noticed. Fundamentally, apathy is considered as a decrease of     cognition and behaviour to go in goal. Assessment of psychological and behavioural symptoms     is realised principally with neuropsychiatric scales. These contribute to obtain particular     informations about health of patient allowing by patient and caregiver discussions and     impressions of clinician. These scales are simples but loss of subjectivity. An alternative     of this method is the use of gerontechnology as actigraphy (system out-patient which records     locomotive activity with the help of piezo-electrical sensor fixed on a bracelet) and video     recording which is associated to an informatic treatment of signal in order event     recognition.      The aim of study is to realise an objective assessment of activities go in goal during     experimental sequence which has well-characterized acts, using at the same time an     actigraphic record of activity motive (system of assessment indirect of apathy fit) and a     video records which uses an informatic event recognition system. The assessment will realise     with participants controls (n=30) and Alzheimer disease patients with (n=20) or without     (n=20) apathy, during well-characterized records. The final aim is to obtain a particular     assessment of some disorders behaviours, as apathy, which is principally characterize by a     decrease of behaviours to go in goal.   "
145176|NCT01384136|"     The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in     cases of genetic instability and secondary to stress.      The investigators aim is to study the telomere system in cord blood and in the placenta     immediately after the delivery in pregnancies defined as high risk pregnancies following     sterss events such as placental insufficiency, preeclampsia, diabetes.      The investigators intend to compare the telomere system in maternal blood to cord blood and     to placental biopsies and to study the influence of different stressogenes on this system.   "
145161|NCT01384331|"     Most Implanon users experience a reduction in the frequency and volume of menstrual bleeding,     but a substantial minority experience unpredictable and frequent and/or prolonged episodes of     bleeding. This is a double blind, placebo controlled, randomised study with an additional     randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are     Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be     recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon     7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily     menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled     into the treatment phase provided that they have met one of the World Health Organization     criteria for prolonged or frequent bleeding Following the initial 90 day record, eligible     women will begin designated treatment on day 1 of the next episode of bleeding or spotting.     Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting     episode and will continue through 90 days.   "
145162|NCT01384318|"     In common clinical practice, one means of ensuring an acceptable cuff pressure in     endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O     and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of     this study is to validate this technique by checking the intracuff pressure using a manometer     after the cuff is inflated using the CPAP technique.   "
145163|NCT01384305|"     Even though rare disorders usually have limited case numbers, they have induced huge impacts     on patients and their families, and has heavily burdened on our society and healthcare system     as well. Therefore, it is essential to detect the occurrence of disorders and thus take     appropriate measures as early as possible. The preventive goal is based on comprehensive     understanding on rare disorders, available diagnostic and therapeutic approaches. However,     studies related to rare disorders are often impeded by limited sample sizes and infrequent     exchange of research materials among institutes. After referring to foreign experiences, the     investigators have noticed that a non-profit tissue bank which can reposit biological samples     and thus provide researchers access to samples, may be a solution. Through sharing this     public asset, the investigators believe not only quantity and quality of rare disorder     studies will be improved, the collaboration between various research institutes can also be     strengthened afterwards. Most important of all, those achievements can ultimately benefit     patients, families and the whole society.   "
145164|NCT01384292|"     The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment     of opioid-induced constipation (OIC) in patients with cancer-related pain, including those     patients that have inadequate response to laxative therapy (LIR).      The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week     extension with active treatment (part B).   "
145165|NCT01384279|"     The primary aim of the study is to investigate the efficacy of metformin and topiramate on     second-generation antipsychotic-induced obesity. The secondary domain we look at is the     adverse effects of both drugs. The investigators hypothesize that metformin and topiramate     are effective in treating obesity induced by second-generation antipsychotics.   "
145166|NCT01384266|"     Patients are routinely given steroid eye drops following cataract surgery. This study will     compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used     following cataract surgery. Patients will be randomly assigned to one drop or the other, and     evaluated for inflammation and intraocular pressure as part of the comparison. The study     Doctor will be masked as to which drop the patient receives to avoid bias.   "
145167|NCT01384253|"     Monoclonal antibodies can transport and deliver radioactive elements capable of releasing     sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study     alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path     length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for     metastatic diseases.      This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab,     its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive     intraperitoneal cancers.   "
145168|NCT01384240|"     The overall objective of this study is to obtain data to evaluate whether high-resolution     imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and     neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope     device which can be used during standard endoscopy to image the gastrointestinal epithelium.     Theoretically, by visualizing superficial mucosal changes at a high-resolution and     magnification, the investigators will be able to obtain optical images that can be used to     guide endoscopic biopsy and polypectomy. This may foster the selective targeting of     dysplasia/neoplasia, thereby improving diagnostic accuracy.   "
145169|NCT01384227|"     The overall objective of this study is to obtain data to evaluate whether high-resolution     imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic     (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope     device which can be used during upper endoscopy to image the gastrointestinal epithelium.     This is an exploratory, not a comparative, study designed to evaluate the feasibility of     using this instrument in Barrett's esophagus.   "
145170|NCT01384214|"     The purpose of this study is to evaluate swallowing efficiency in patients with cervical     dystonia following treatment with botulinum toxin Type A.   "
145171|NCT01384201|"     This is a prospective randomised study investigating the use of chromoendoscopy and confocal     laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of     gastric cancer.   "
145172|NCT01384188|"     The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and     morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal     women.   "
145173|NCT01384175|"     The aim of the present study was to assess the efficacy of thoracic epidural anesthesia     followed by postoperative epidural infusion and patient-controlled epidural analgesia with     ropivacaine/fentanyl in off-pump coronary artery bypass grafting   "
145174|NCT01384162|"     This is an open label safety and tolerability continuation study of intracerebroventricular     administration of sNN0029, containing the growth factor VEGF165, in patients with amyotrophic     lateral sclerosis that have previously participated in study sNN0029-001. The intention of     the study is to investigate safety and tolerability of intracerebroventricular administration     of sNN0029 and whether it can improve motor function and prolong survival in patients with     ALS.   "
145177|NCT01384123|"     Sarcoidosis is a heterogeneous multisystem disorder of unknown etiology which often presents     with bilateral hilar lymphadenopathy, pulmonary infiltration and ocular and skin lesions. In     addition to possible changes in forced vital capacity (FVC) and carbon monoxide transfer     factor (TLCO), a higher prevalence of clinical depression, reduced health status and exercise     intolerance have been observed in patients with sarcoidosis.      Reduced health status has been related to decreased pulmonary function, depressive symptoms,     and to respiratory muscle weakness. Exercise capacity is believed to be limited by dyspnea,     an insufficient heart rate response, decreased arterial oxygen tension during exercise,     excessive and inefficient ventilation and by respiratory muscle weakness.      In the past, exercise capacity was shown to be limited by skeletal muscle weakness in     patients with chronic pulmonary or cardiac disease. 67% of the sarcoidosis patients studied     by Miller et al terminated their peak exercise test due to leg complaints. Skeletal muscle     weakness is therefore still assumed to be present in patients with sarcoidosis.      Treatment with oral corticosteroids, clinical symptoms of depression, myositis, self-reported     complaints of fatigue and high circulating levels of tumour necrosis factor-α (TNF-α) are all     present in patients with sarcoidosis and can all affect skeletal muscle force and exercise     capacity. Additionally, low levels of circulating insulin-like growth factor I (IGF-I), which     can be induced by high levels of TNF-α, and high circulating levels of interleukin (IL)-6 and     IL-8 (CXCL8) have been associated with skeletal muscle weakness. These interleukins are part     of the current concept of the immunopathogenesis of sarcoidosis16 and may be raised in     patients with stable sarcoidosis.      Recent studies have shown that pulmonary rehabilitation program can lead to improve in the     health status and anxiety among patients with chronic obstructive lung disease .However, no     study has evaluated the role of pulmonary rehabilitation among patients with sarcoidosis.   "
145178|NCT01384110|"     The primary endpoint of this trial will be to evaluate if a single administration in human of     a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce     postprandial glycemia and insulinemia.   "
145179|NCT01384097|"     A systematic literature search a goal-directed haemodynamic algorithm was created. The     hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and     can improve clinical outcome.   "
145180|NCT01384084|"     The investigators have performed colposacropexy in women with uterovaginal prolapse for many     years with satisfactory results.      This study was designed to compare whether, in the treatment of patients with uro-genital     prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure     such as mini-sling is associated with a reduction of post-operative urinary incontinence     (correction of pre-existent urinary incontinence and prevention of masked urinary     incontinence).   "
145181|NCT01384071|"     Some physicians, physiotherapists and nurses use or even suggest unstable shoes in cases of     low back pain. No studies on the real effects of these shoes on low back pain in health care     professions have been carried out and therefore as yet there is no real evidence of their     effectiveness. Thus the investigators assume that wearing unstable shoes over a period of six     weeks could reduce low back pain and functional disability due to the changes of the gait and     posture and may increase the quality of life.      The purposes of this study are:        1. To evaluate the modifications of pain level, functional capacity and quality of life          among individuals with moderate level of non-specific chronic low back pain after          wearing unstable shoes.        2. To quantify biomechanical modifications of gait and posture.   "
145182|NCT01384058|"     It is of interest how ezetimibe alone or in combination with statin may influence atherogenic     dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary     objective of this study will be whether there is a change of the concentrations of     Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.   "
145350|NCT01381874|"     The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate     plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane,     each compared with oral exemestane alone, in postmenopausal women with estrogen     receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after     treatment with letrozole or anastrozole.   "
145183|NCT01384045|"     Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive     diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP), carry     out a randomized-controlled trial of usual care versus an outreach intervention designed to     increase guideline concordance with American Diabetes Association (ADA) recommendations for     blood pressure, Low-density lipoprotein (LDL), and glycosylated hemoglobin (A1c) goals,     referrals for retinal exams, and aspirin therapy.Primary hypotheses: The proportion of     patients meeting goal will be 10% higher in the intervention compared with control group in     the following domains: 1. LDL<100 mg/dL; 2. A1c<7.0%; and 3. Systolic blood pressure<130 mm     Hg or diastolic blood pressure<80 mm Hg.   "
145184|NCT01384032|"     Cardiovascular disease (CVD) is recognised as one of the main causes of death in the western     world. LDL- cholesterol ('bad' cholesterol) and other lipids (fats) are important CVD risk     factors. Apolipoprotein E (apoE) is an important transporter of fats in the blood. ApoE comes     in E2, E3 and E4 forms, depending on your genetic make up. Approximately 60% of the UK     population are E3/E3, 25% E4 carriers and 15% E2 carriers. There is some evidence to suggest     that an E4 genotype may put you at modestly higher risk of CVD. Furthermore although very     inconclusive previous studies have suggested that E4 individuals are slightly more sensitive     to the LDL-cholesterol modifying effects of dietary fats (saturated fat, total fat, fish oil)     showing slightly, greater reductions when low levels of these fat are consumed, and greater     increases when high levels of these fat are consumed. Therefore, the aims of the Satgene     study is to examine the impact of modifications in dietary total fat and saturated fat     intakes, alone and in combination with fish oil supplement on LDL-cholesterol and other blood     lipids, in individuals with an E3 and E4 genotype. The levels of total fat and saturated fat     used in the current study are within the range observed in a typical UK population.   "
145185|NCT01384019|"     The investigators examined the mechanism underlying the lack of benefit from distal     protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial     Infarction (STEMI) in a prospective, randomized trial.   "
145186|NCT01384006|"     To expand the donor pool for pancreas allografts. For detailed description please see below.   "
145187|NCT01383993|"     In this study we will measure the concentration of the drug called voriconazole which is used     to fight infections caused by fungus in children who usually are cancer patients and have     their immune system down. Since we know the dose in adults, and we think we know the matching     doses in the young patients ages 2 to less than 15 years old, we will compare the amount of     drug that goes into the system with what we know works in adults. We give the drug by a     needle directly into the blood, then few days later we stop that and give the drug by mouth.     Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.   "
145188|NCT01383980|"     Surgical patients fed up until the point of surgery will have safe delivery of more calories     compared to a group whose feeding is held at midnight prior to surgery.   "
145210|NCT01383694|"     Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of     substance P. These actions may accelerate the oropharyngeal swallow response, improving the     swallowing of dysphagic patients.   "
145211|NCT01383681|"     This is a retrospective study of patients with spasticity in the Spanish population.   "
145189|NCT01383967|"     This is a two part study. Part A is a multiple-ascending dose study in up to 6 different     groups of healthy subjects, with approximately 12 subjects in each of the groups. Part A will     allow investigation of up to 6 different doses of LY2979165. The drug will be administered     for a total of 14 days. Subjects will be resident in the clinical research unit (CRU) from     Day -1 (the day before dosing) until Day 15.      Part B will investigate a dose of LY2979165 previously administered in Part A in up to 12     subjects. The drug will be administered for a total of 14 days. In addition to the same     assessments as would have been completed in Part A, subjects in Part B will also have     cerebrospinal fluid samples taken from the lower lumbar region of their spine.   "
145190|NCT01383954|"     The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA)     patients using the diclofenac gel.   "
145191|NCT01383941|"     This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic     characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17     years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.   "
145192|NCT01383928|"     This will be a phase 1/2, multicenter, open-label study using the oral formulation of     IXAZOMIB administered twice weekly in combination with lenalidomide and low-dose     dexamethasone. Both phases of the study will include patients who have newly diagnosed     multiple myeloma and have not previously received systemic treatment.      Both the phase 1 and the phase 2 portions of the study will include induction therapy     consisting of 1 year of therapy followed by maintenance therapy that will continue until     progressive disease or unacceptable toxicity. Maintenance therapy will be IXAZOMIB alone on     Days 1,4,8, & 11 of a 21-day cycle.   "
145193|NCT01383915|"     Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode     of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors     of the disease development.      Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of     Bipolar Disorder (BPD) or schizophrenia.      Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will     differentiate between individuals developing BPD and schizophrenia.   "
145194|NCT01383902|"     This comparative pilot study is designed to compare the rates of gastric emptying and by     inference rates of digestion of challenge meals. Two types of meal will be compared,     chocolate mousse style dessert and chocolate bars. The information from this study will then     be compared to the elicitation times for both objective and subjective symptoms in the     allergic patients who have been challenged in a different study using the same two meals.   "
145203|NCT01383785|"     Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the     thrombus occlusion is better than normal injection during primary percutaneous intervention     (PCI) for the treatment of acute myocardial infarction. Using this modification of injection     method the investigators can achieve less microvascular damage and a reduction of the infarct     size with a significant improvement of the outcome at six months.   "
145732|NCT01376843|"     The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and     Quantiferon-TB Gold In tube assay in health care workers.   "
145195|NCT01383889|"     This will be an open randomized clinical trial involving pregnant women between 35 and 37     weeks randomized to two modalities of exercise: treadmill or stationary bike. The study     hypothesis is that exercise on a stationary cycle causes less maternal and fetal effects in     relation to treadmill exercise.We will study the acute effects of exercise for both the     mother and the fetus, monitoring the parameters before, during and after exercise for 20     minutes. The exercise intensity will be moderate, remaining between 60% and 80% of maximum     heart rate. Women will be monitored with a recording equipment of ABPM (ambulatory blood     pressure monitorization) and continuous cardiotocography and blood will be collected to     measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and     after exercise. The analysis variables are: maternal heart rate and blood pressure, fetal     heart rate, number of fetal movements, transient accelerations, decelerations, short-term     variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total     cholesterol and HDL.The analysis will be based on intention to treat, according to the     recommendations of the CONSORT (2010).   "
145196|NCT01383876|"     Cervical collars are commonly used to provide external immobilization after elective     Posterior Cervical Laminectomy and Interbody Fusion (PCLIF). The rationale for collar use is     the perception and assumption that it can prevent early instrumentation failure and promote     successful spinal fusion. However, there are a number of potential complications associated     with cervical collars such as skin breakdown, ulceration, neck pain, impedance upon     activities of daily living, and impaired swallowing. Considering these conflicting factors,     there is wide disagreement among spinal surgeons about the utility, benefits, and necessity     of collar use following elective PCLIF.      Hypothesis: Wearing a cervical collar for 12 weeks after posterior cervical laminectomy and     instrumented fusion will not demonstrate substantial benefits as measured by the incidence of     instrumentation failure, rate of nonunion, or clinical outcome measures.      Specific Aim I: To compare the outcomes of surgery in patients who will wear a cervical     collar for 12 weeks following surgery versus those who will have the collar removed prior to     discharge after surgery.   "
145197|NCT01383863|"     The purpose of the protocol is to assess the rate of castration resistance, disease     progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT)     induction in a study cohort of patients with advanced disease.   "
145198|NCT01383850|"     Infants born between 28 and 32 weeks' gestation with radiological findings and clinical     symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway     Pressure (NCPAP) within the first hour of life, were randomized to receive either standard     medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life,     followed by medical air until NCPAP was needed. The aim of the study was to assess the     therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20%     oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in     terms of reducing the rate of mechanical ventilation (MV).   "
145212|NCT01383668|"     This phase I trial studies the side effects and best dose of sirolimus and gold sodium     thiomalate when given together in treating patients with advanced squamous non-small cell     lung cancer (NSCLC). Sirolimus and gold sodium thiomalate may stop the growth of tumor cells     by blocking some of the enzymes needed for cell growth   "
145252|NCT01383148|"     This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the     efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV     non-small cell lung cancer (NSCLC).      TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain)     carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has     been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1     antigen.      TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a     non-specific activation of several components of the immune system.   "
145199|NCT01383837|"     Adolescents with substance use disorders (SUD) are at substantial risk for contracting     HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction     interventions have been developed to meet their unique needs, and none use a family-based     intervention approach, which the literature recommends as the focus for intervention for     youth. Current state policies neither require providers in clinics delivering substance use     treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for     HIV/STI prevention. There is clear public health need to develop innovative methods of     service delivery and effective strategies of HIV/STI sexual risk reduction that address     multiple contexts of risk (i.e. family) for this high risk population. The current proposal     addresses this need by developing a provider-delivered HIV sexual risk reduction intervention     to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help     families under their care to more comfortably address the adolescent's sexuality; 2) promotes     youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents     with SUD in care.   "
145200|NCT01383824|"     The purpose of this study is to monitor the performance and of the Silent Hip™ in the     treatment of patients with hip joint disease requiring a total hip replacement. Patients who     enter the study will be evaluated at regular intervals following hip surgery using patient,     clinical and x-ray assessments.   "
145201|NCT01383811|"     The objective of this study is to determine the effects of adjunct exercise in treatment     resistant depression. The central hypothesis for the research is that adjunct exercise with     usual care in Treatment Resistant Depression (TRD) will have significant effects in improving     the psychiatric symptoms in comparison to usual care alone.   "
145202|NCT01383798|"     The specific aims of the current study were: 1) To determine the prevalence of IDNA in a     sample of female rowers at the beginning of a training season; 2) To determine how IDNA     affects endurance training and performance at the beginning of a training season; 3) To     determine how iron supplementation affects iron status, training and performance in IDNA     female collegiate rowers. The researchers hypothesized that IDNA affects endurance     performance in female collegiate rowers both in and outside of the laboratory, and that iron     supplementation of IDNA rowers will improve iron status, and consequently, training quality     via increased energetic efficiency.   "
145204|NCT01383772|"     The purpose of this study is to determine the risk of failing the visual field criteria to     hold a driving license following retinal laser treatment delivered with a multi-spot     photocoagulator.   "
145205|NCT01383759|"     The goal of this clinical trial is to determine the toxicity and also the efficacy of a     treatment that includes the following treatment: Two medications, bortezomib and     dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged     course of treatment with bortezomib and dexamethasone after transplantation. This type of     treatment has been very effective in multiple myeloma. However, there is little experience     with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD)     or amyloidosis. The investigators and others have treated patients who have MIDD and     amyloidosis with bortezomib and autologous stem cell transplantation and have had success     with this treatment. But the combination of autologous transplant with BD given before and     after the transplant is a new way of treating these diseases, which the investigators believe     will be very effective.   "
145206|NCT01383746|"     Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor     prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from     curative surgical resection and most patients have medical treatment by palliative treatment     by palliative chemotherapy. It is not standard first-line chemotherapy validated for     unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are     observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4     months). In case of tumor progression ater this first line therapy, no treatment is currently     being validated.      RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium     microspheres.      In the patients with unresectable CCK , the first pilot studies showed interesting results     with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.      Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic     CCK in tumor progression after first-line therapy.   "
145207|NCT01383733|"     This multicenter, open-label, multiple ascending dose study will evaluate the safety,     tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with     advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640     intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or     unacceptable toxicity occurs.   "
145208|NCT01383720|"     This is a prospective, single-arm feasibility study designed to assess the acute safety and     performance of the Lotus Valve System for transcatheter aortic valve replacement in     symptomatic patients with calcified aortic valve stenosis and who are at high risk for     surgical intervention.   "
145209|NCT01383707|"     The multicenter, open-label, single-arm, non-randomized, two-stage Simon's design, phase II     study (The CLMO-001 Trial) will evaluate the efficacy and safety of bevacizumab in     combination with mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU] and oxaliplatin) in     participants with colorectal cancer and liver metastases. Participants will receive     combination therapy of bevacizumab 5 milligrams per kilogram (mg/kg) intravenous (IV) dose     and mFOLFOX-6 every 2 weeks during Cycles 1-5 and Cycles 7-12. Participants will receive     mFOLFOX-6 alone (without bevacizumab) on Cycle 6. In between Cycle 6 and 7, participants will     undergo liver surgery if operable. Thereafter participants will receive bevacizumab (5 mg/kg     IV every 2 weeks) alone for 52 weeks (26 cycles) after the end of the post-operative phase     (maintenance therapy). At the end of the preoperative treatment phase (Cycles 1-6),     participants showing different alternative conditions admitted by the protocol will undergo     different management (alternative study designs 1 to 3).   "
145213|NCT01383655|"     In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing     symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always     satisfactory.      The purpose of this trial is to investigate the effectiveness of iv-magnesium in the     treatment of moderate or severe bronchial obstruction associated with viral infection in     small children.      The study population will include the children attending the Pediatric Emergency Department     of Oulu University Hospital because of respiratory infection and bronchial obstruction that     is not relieved with conventional treatment. After written consent from the parents, the     children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The     primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from     the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points     and length of hospital stay.      The sample size is 64 children at the age of 6 months to 4 years.      If iv-magnesium is effective in relieving viral infection associated bronchial obstruction,     that would be an important addition to the treatment of this common disease.   "
145214|NCT01383642|"     Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a     precursor to the frailty phenotype seen in the elderly population. A recent study found that     vestibular dysfunction is common in the US population, and that the prevalence of this     impairment increases steeply with age. However, it is unknown whether the aging process has     global effects on the vestibular end-organ or whether specific structures, e.g. the     semicircular canals or the otoliths, are selectively impaired. Moreover, the clinical     implications of specific deficits of the vestibular end-organ are unclear. As such, the aims     of this proposed research are: 1) to evaluate whether the normative aging process is     predominantly associated with dysfunction of the semicircular canals (as measured by caloric     and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by VEMP     testing); 2) to determine if there are any characteristic clinical features associated with     the subtypes of vestibular dysfunction; and 3) to assess whether dysfunction of the     semicircular canals or of the otoliths is associated with a higher risk of frailty and falls.     The investigators plan to pursue these aims through a cross-sectional and prospective cohort     study of a group of individuals age 70 and above. Vestibular physiologic tests will be     administered to all study participants, and test results will be correlated with baseline     clinical symptoms and frailty status as well as prospective one-year fall risk. A greater     understanding of vestibular physiologic deficits and their clinical implications in older     individuals can inform the development of rational vestibular rehabilitation strategies that     may more effectively mitigate the frailty phenotype and reduce fall risk.   "
145215|NCT01383629|"     This RCT aims to study the effect of preoperative counselling in reducing patients fear and     visual perception during vitrectomy under local anaesthesia.   "
145351|NCT01381861|"     The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with     recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.   "
145216|NCT01383616|"     Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression     fractures has been shown to be successful in providing acute pain relief, enabling improved     function, and restoring of vertebral body height. However, limited prospective data exists in     the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to     bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to     compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon     kyphoplasty.   "
145217|NCT01383603|"     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with     allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide     desensitising vaccine currently being developed for treatment of cat allergy.      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at     the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently     exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical     development of peptide immunotherapy vaccines, in addition to providing an improved     understanding of the underlying molecular mechanisms of efficacy, thus providing new leads     for therapeutic intervention.   "
145218|NCT01383590|"     Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with     allergic rhinoconjunctivitis. Cat-PAD is a novel synthetic, allergen derived peptide     desensitizing vaccine currently being developed for the treatment of cat allergy.      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at     the conclusion of therapy. The aim of this study is to identify changes in potential     biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that     equate with clinical efficacy.   "
145219|NCT01383577|"     Rubber band ligation is a widely adopted treatment of internal hemorrhoids in busy     coloproctology institutions. All three major hemorrhoidal clusters (left lateral, right     anterior and right posterior) use to be ligated in order to obtain therapeutic success. It is     commonly performed either through the ligation of a single hemorrhoid per session spaced by     some few weeks to the second and third sessions, or of all three major hemorrhoids in one     single session. Advocates of either method of hemorrhoidal ligation have arguments to defend     their choice in terms of advantages, supported mainly on personal preferences. The     investigators objective is to determine, through a controlled double-blinded randomized     study, if there is any superiority of single hemorrhoidal ligation per session (in a total of     three sessions) over the method of ligation of all three main hemorrhoids in a sole session     in terms of therapeutic success (resolution of pre-ligation symptoms), morbidity, patient     satisfaction and costs (institutional, labor and patient-related).   "
145231|NCT01383421|"     This study is a non-confirmatory post-marketing observational study to explore and describe     the effectiveness of adalimumab on rheumatoid arthritis (RA) treatment course and participant     satisfaction over time in context with utilization of a patient support program (PSP). The     core elements of the PSP were call centers (in and outbound)/hotlines, nursing services,     starter packs, provision of educational materials (print and digital) regarding RA and     adalimumab, and injection guides. Other elements of the PSP, which varied between countries,     included (but were not limited to) refill reminders, email contacts, support groups, and     newsletters.   "
145232|NCT01383408|"     Previous studies have shown that specially trained sniffer dogs are capable to discriminate     breath samples of patients with lung cancer and healthy individuals. So far it is not known     whether this differentiation is specific for lung cancer or just identifies any form of     (solid) tumor. Therefore, the dog's ability to differentiate between lung cancer, breast     cancer and ovarian cancer is tested.   "
145220|NCT01383564|"     Obstructive sleep apnea syndrome (OSAS) and asthma are both common disorders in Hong Kong,     with prevalence of at least 4% among the middle-aged male Hong Kong (HK) Chinese populations     and 7.2% in young adults respectively. OSAS is characterized by repetitive episodes of upper     airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime     sleepiness, impaired cognitive function and poor health status. Continuous positive airway     pressure (CPAP) is the first line of therapy for sleep apnea. CPAP provides a pneumatic stent     for the upper airway, eliminating the airway collapse during inspiration.      Asthma is a chronic inflammatory disorder of airways, characterized by airway     hyperresponsiveness that leads to recurrent episodes of wheezing, breathless, chest     tightness, and coughing, particularly at night or in the early morning. Nocturnal asthma is     not a different condition from asthma and is defined as a variable worsening of asthma at     night, in which the mechanisms are not completely understood.      The prevalence of OSAS in asthmatic patients has not yet been studied, but several studies     have reported an increased prevalence of OSAS symptoms in asthmatic patients. OSAS and asthma     share some common risk factors, which include obesity, gastroesophageal reflux and rhinitis.     CPAP treatment has been shown in prospective clinical studies to have a positive impact on     asthma outcome in patients with concomitant OSAS, for example, improvement of asthma related     quality of life in subjects with stable mild-to-moderate asthma, but there was no change in     the airway responsiveness or forced expiratory volume in one second. Although important,     these studies included small numbers of participants used nonrandomized designs. This study     is to assess the impact of CPAP treatment on asthma control among patients with nocturnal     symptoms and moderate OSAS.   "
145221|NCT01383551|"     The proposed of this study is to determine if an intervention, known as the Becoming     Parents programme, is more effective in improving the mental health, marital relationship     and parental competence of expectant couples in a Chinese community.   "
145222|NCT01383538|"     The purpose of this phase I study to determine the optimal dose for the combination of     IPI-926 plus FOLFIRINOX (5-fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin)     chemotherapy in patients with pancreatic cancer.   "
145223|NCT01383525|"     The trial objectives are to establish the safety & efficacy of using a DLTP laser to perform     laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle     glaucoma (Including Pigmentary & Exfoliative Glaucoma), that did not achieve adequate IOP     control by conventional therapy.   "
145224|NCT01383512|"     Upper limb motor control after a stroke may be improved with rehabilitation robotics at a     subacute stage. The aim of this multicenter controled randomized single blind study is to     define the place of rehabilitation robotics at this phase of the rehabilitation process. Both     groups will realize the same time of rehabilitation. The cost benefit ratio will be compared     in each group through medical assessment of improvement and definition of the costs due to     the rehabilitation process.   "
145225|NCT01383499|"     The aim of this trial is to select an optimum dose may be selected based on bronchodilator     efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.   "
145226|NCT01383486|"     A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their     own use based on expected duration of pain greater than 12 hours.   "
145227|NCT01383473|"     Many children with cancer cannot participate regularly in school due to frequent     hospitalizations for treatment or treatment related effects such as pain, nausea, and     fatigue. Prior studies have shown that children with cancer desire to attend school while     receiving therapy despite these challenges, and that they report psychological and     psychosocial difficulties if unable to attend. While school attendance has been found to     correlate with Health-Related Quality of Life (HRQoL), self-efficacy beliefs, and     self-esteem, little is known about how children with cancer experience school attendance     while receiving active cancer therapy. The purpose of this study will be to explore how 6-12     year old children with cancer perceive school attendance pre and post diagnosis during active     therapy as measured at one-time point, 6 months (± 2months) into active therapy.   "
145228|NCT01383460|"     50 patients of Acute-on-chronic liver failure (ACLF) will be enrolled and randomized into     G-CSF+EPO or Placebo arms      Treatment protocol To administer G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at     days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with     Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).      Standard medical therapy included as per requirement lactulose, bowel wash, albumin,     terlipressin, antibiotics (if indicated) will be continued and recorded. Pentoxiphylline in     alcoholic hepatitis and Tenofovir in Hep B reactivation Controls: Standard medical therapy     will be given along with placebo in similar prefilled syringes.      Follow up Physical examination will be done daily, after 1 week and at 4 weeks, at 2 months,     at 3 months and at 6 months CBC on alternate day for 1 week, at end of 1 week and then at end     of 4 weeks , at 2 months, at 3 months and at 6 months      KFT on alternate day for 1 week, at end of 1 week and then at end of 4 weeks, at 2 months, at     3 months and at 6 months LFT along with PT/INR on alternate day for 1 week, at end of 1 week     and then at end of 4 weeks, at 2 months, at 3 months and at 6 months AFP at baseline, after 4     weeks, at 3 months and at 6 months Liver regenerative potential efficacy testing at baseline     and after 4 weeks   "
145229|NCT01383447|"     This phase I/II trial is studying the side effects and best dose of entinostat when given     together with imatinib mesylate and to see how well it works in treating patients with     relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.     Entinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the     enzymes needed for cell growth   "
145230|NCT01383434|"     Patients with severe, refractory aplastic anemia have a severe, life threatening disease in     their bone marrow. Refractory disease means that disease has come back or not responded after     receiving one or more immunosuppressive treatments. High dose chemotherapy followed by bone     marrow transplantation (BMT) has been used to treat blood diseases like aplastic anemia but     complications from Graft vs Host disease (GVHD) and graft failure have limited the survival     for those patients.      Another study done here at Johns Hopkins has shown that in patients with other diseases     (blood cancers) some immunosuppressive drugs given after the BMT has decreased how often     patients had complications of GVHD and engraftment failure.      This research is being done to find if this approach will help patients with aplastic anemia     who have failed other treatments will have better outcomes.   "
145233|NCT01383395|"     To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult     subjects.   "
145253|NCT01383135|"     The purpose of the study is to conduct a pilot test of a new tracer in healthy human     volunteers to define normal tracer biodistribution (where the tracer goes), stability (how     much metabolises), pharmacokinetics (how much stays in which organs and for how long), and     radiation dosimetry (organ radiation dose). The same radiopharmaceutical will then be tested     in cancer patients.   "
145234|NCT01383382|"     Using individualized patient estimates of procedural risks and benefits, this project will     transform the process of informed consent for coronary angioplasty into a dynamic educational     tool for patients and physicians and is a direct response to the Institute of Medicine's call     for a more evidence‐based, efficient, patient‐centered healthcare system. It is hypothesized     that patients will develop a greater understanding of their individual risks and benefits     from PCI, will be empowered to more actively engage in shared decision-making, as well as     have improved awareness of their responsibility to adhere to dual anti-platelet therapy if     treated with a drug eluting stent (risks for target vessel revascularization with bare metal     and drug eluting stents are also provided in the new consent form). It is also anticipated     that physicians, in turn, will use these individualized estimates to better discriminate     between risks and benefits among different bleeding avoidance therapies so as to improve the     safety and cost-effectiveness of PCI.   "
145235|NCT01383369|"     The purpose of this study is to evaluate sleep cycle before and after fast-track arthroplasty     (3 days before and 10 days after) combined with cognitive testing preoperatively, on     postoperative day 1,2,10.   "
145236|NCT01383356|"     The data from this study will be used to compare the kinetic profile of metformin 500mg in     linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference     product administered concomitantly with linagliptin 2.5 mg tablet.   "
145237|NCT01383343|"     This phase I trial studies the side effects and best dose of sorafenib tosylate when given     together with bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil in     treating patients with colorectal cancer that has spread to other parts of the body. Drugs     used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Sorafenib tosylate may stop     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal     antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and     spread. Sorafenib tosylate and bevacizumab may also block tumor growth in different ways by     targeting certain cells. Giving sorafenib tosylate and bevacizumab together with combination     chemotherapy may be a better treatment for colorectal cancer.   "
145238|NCT01383330|"     The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml,     Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed     condition.   "
145422|NCT01381068|"     This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the     delivery room. The use of the monitor is compared with clinical assessment of ventilation.     The hypothesis is that using the monitor would results in a decrease in the incidence of     hypo- or hypercapnia on admission to the NICU.   "
145239|NCT01383317|"     Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in     patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving     procedure many people have a significant amount of postsurgical pain. Severe postsurgical     pain may lead to chronic pain in some people. Remote Ischemic Preconditioning may reduce     the amount of postsurgical pain. Remote ischemic preconditioning is done by inflating a     balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a     few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to     three times. This procedure causes the body to increase its natural pain relief system that     may help to decrease the amount of postsurgical pain.   "
145240|NCT01383304|"     Previous studies indicate that patients with cardiovascular disease have a variable response     to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial     infarction. This has given rise to the phenomenon aspirin low-responsiveness. Laboratory     aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet     production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a     low platelet response to aspirin results in an increased risk of future thrombotic events is     of great clinical significance, but is still unknown.      The investigators hypothesize that patients with a reduced response to aspirin, determined by     platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher     risk of thrombosis.      The purpose of this study is to investigate whether a higher incidence of cardiovascular     events is found in patients with coronary artery disease (CAD) having a reduced biochemical     response to aspirin compared with CAD patients having a normal biochemical response to     aspirin. In addition to CAD, all patients have at least one of the following risc factors:     previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.   "
145241|NCT01383291|"     -  Women who underwent mesh or sling procedures to correct pelvic organ prolapse will be          enrolled.        -  Their data will be collected from the files.        -  Comparison between two groups will be carried our: Those who underwent a posterior IVS          and those who underwent posterior prolift procedure.        -  The data will be obtained by questionaires by a telephone interview by a physician who          did not participate in the surgery.        -  Follow-up physical examination data will also be obtained.   "
145242|NCT01383278|"     This is a 2-group RCT in 380 tobacco-using medical patients that will compare a single     session, computer-directed 5 A's intervention for smoking (experimental condition) to     screening and resource provision (control condition). Follow-up visits will occur at 1 and 3     months post study enrollment. Measures will focus on tobacco use and related psychosocial     outcomes (e.g. mood, stress). We will compare resources used and economic costs needed to     implement each intervention.      The Investigators hypothesize that patients receiving the computer-directed intervention will     have significantly higher tobacco abstinence rates at 3 months post study enrollment compared     to the control group. If indeed the computerized intervention increases tobacco abstinence     rates compared to the control group, this intervention could be used to increase access to     treatment for the millions of US smokers, ultimately reducing tobacco mortality and morbidity     rates in this country.   "
145243|NCT01383265|"     In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a     dilute solution of Indigocarmine (IC) delivered by the water method (study method) will     improve adenoma detection rate compared with the water method with plain water alone (control     method).   "
145244|NCT01383252|"     In a prospective, randomized, controlled study, two methods (water method vs. air method) of     performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC     screening. The investigators hypothesize that:        1. Study method increases overall cecal intubation with comparable assessment of current          experience and patient willingness to repeat future colonoscopy compared with          conventional colonoscopy        2. Study method improves bowel preparation and increases polyp pickup rate   "
145245|NCT01383239|"     Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to     increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million     physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of     $17,427 per patient in 2004. As the population ages, the number of rotator cuff repair     surgeries is increasing; in New York State, rotator cuff repairs increased by 50% over a 5     years span 48. Unfortunately, surgically repaired rotator cuff tears fail in at least 20% and     up to 94% of individuals 3, 9, 13, 20, 28, 40, 52, 58. While many non-modifiable variables     have been associated with failure of repair, postoperative rehabilitation is a modifiable     variable that has received little attention. The investigators propose a multicenter     randomized controlled trial to study one important strategy for postoperative rehabilitation:     early versus delayed onset of physical therapy. This pilot study will enroll patients with     isolated supraspinatus tears who undergo a standard surgical repair technique. The     investigators hypothesize that delaying the onset of physical therapy will improve healing     and patient outcomes. Our primary outcome variable is the Western Ontario Rotator Cuff (WORC)     Index (a disease specific validated outcome measure). Because outcome measures may not always     correlate with healing of rotator cuff repairs 50, our secondary outcome measure will be     healing based on MRI scans 12 months after surgery.   "
145246|NCT01383226|"     Patients are often referred for E(B)US examination and sampling of enlarged mediastinal     and/or hilar lymph nodes that are not visible on a standard chest X-ray but are discovered by     accident on CT scan performed outside the context of lung cancer or extrathoracic     malignancies. Since CT scan is largely used and E(B)US is a minimally invasive technique,     these cases are explored more frequently but so far nothing is known, however, on the     prevalence of abnormal findings in EBUS sampling in this particular population and on the     clinical implications (mainly therapeutical implications) of E(B)US findings.   "
145247|NCT01383213|"     The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2     administration by a Venturi mask in terms of achievement of criteria for endotracheal     intubation during severe acute respiratory failure caused by pneumonia   "
145352|NCT01381848|"     The purpose of this study is to measure drug levels of doripenem in blood samples collected     before and after administration of doripenem to infants less than 12 weeks of age who are     hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and     are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will     also be assessed.   "
145248|NCT01383200|"     In this study the investigators will be comparing two different types of anesthetic, a     numbing eye drop and a numbing gel, to test if they are equally effective or if one has a     better outcome in terms of the level of comfort you experience one hour and one day after     your surgery. The two medications are commonly used and appear to be equally effective for     other types of eye surgery, such as cataract surgery. This study will show if one type of     anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure,     you will be given a short questionnaire to determine the baseline comfort of your eyes. In     the operating room, one type of anesthetic will be put in one eye, and the other medication     will be put in the other eye. Which anesthetic you get in each eye will be chosen in a random     way (similar to flipping a coin). After your LASIK surgery, the investigators will ask you if     you felt more comfort in your right eye, your left eye, or if they were equal, and the     investigators will ask you the same survey questions that were asked prior to your LASIK to     get more details about your experience.      *Of note- the randomization being done is for which eye will be receiving the lidocaine and     which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and     tetracaine in the other eye, the randomization is for each individual eye. This means, of 11     patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes     received tetracaine.      when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for     tetracaine, giving a total of 22 eyes. This is important to note since the randomization     refers to EYE for each individual patient, and not for the patient (ie: participant means 1     eye, not 1 person in the descriptions below).   "
145249|NCT01383187|"     Deep skin burn injuries, especially extensive deep burns or/and deep burns extending on the     face, hands, feet, genitalia and perineum, remain one of the most challenging therapeutic     problems. Surgical excision of the necrotic burned tissue with subsequent skin grafting of     the affected area has become the golden standard for the treatment of deep partial thickness     and full thickness skin burns and represents the treatment of choice. Despite of all the     progress achieved in the treatment process (artificial skin, cultured keratinocytes), the     therapeutic results are sometimes unacceptable due to functional and cosmetic deficits     causing severe psychological and emotional distress, particularly in the form of disfiguring     and disabling scarring - i.e. hypertrophic scars, joint contractures restricted movement,     peripheral neuropathy, psychiatric and physiological diseases, as well as thermoregulation     disorders. Consequently, the quality of life is markedly decreased. That is why new methods     of burn wounds covering are intensively searched. Based upon the results of available     pre-clinical studies, the local use of autologous platelet concentrate with their active     growth factors appears to be a good and promising possibility how to improve faster and     higher quality of healing deep skin burn wounds.   "
145250|NCT01383174|"     The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn),     improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina     counselors who have had breast cancer provide support to recently diagnosed women. The     investigators call these counselors peer support counselors.   "
145251|NCT01383161|"     This project is designed to study the effects of the dietary supplement curcumin on     age-related cognitive impairment. In particular, the study seeks to determine the effects of     curcumin on cognitive decline and the amount of abnormal amyloid protein in the brain.     Genetic risk will also be studied as a potential predictor of cognitive decline.      Subjects will be randomly assigned to one of two treatment groups: either a placebo or the     curcumin supplement (465 milligrams of Theracurmin™ of which 30 mg is curcumin). The     investigators expect the people receiving the curcumin supplement to show less evidence of     decline and fewer after 18 months than those receiving the placebo. The investigators believe     cognitive decline and treatment response will vary according to a genetic risk for     Alzheimer's.      The investigators will study 132 subjects with memory complaints aged 50-90 years. Initially,     subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic     risk and to rule out other neurodegenerative disorders linked to memory complaints.     Subsequently, subjects will undergo an     -(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile (FDDNP)PET     scan and a baseline neuropsychological assessment to confirm MCI or normal aging diagnosis.     Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo), and     be asked to return every three months for regular MRIs and review sessions. Every 6 months,     subjects will also neuropsychological assessments. At the conclusion of the study, subjects     will be asked to complete a final neuropsychological assessment, MRI scan, PET scan and blood     draw. Additional blood will be drawn at baseline and at 18 months and frozen to assess     inflammatory markers if outcomes are positive.      FDDNP-PET scans will be used to measure the amount of abnormal amyloid plaque- and tau     tangle- proteins in the brain; the MRIs will be used to monitor supplement side effects and     measure brain structure; the neuropsychological assessments will monitor rates of cognitive     decline; the blood draws will be used to test levels of inflammatory markers.   "
145254|NCT01383122|"     Pain following Cesarean delivery remains the most common post-operative complaint, and the     provision of effective and safe analgesia is very important. Pain can impede the mother's     ability to mobilise, and to care for and breastfeed her newborn baby.      Pulsed electromagnetic field (PEMF) devices have been used in various clinical settings,     especially after plastic surgeries, to reduce postoperative swelling and pain, as well as to     accelerate wound repair. PEMF therapy is simple to use, cost-effective and has no known side     effects.      Despite advances in post-operative analgesia, pain relief and maternal satisfaction remain     inadequate in some patients. Improving the quality of post-Cesarean analgesia while limiting     undesirable side effects will enhance maternal satisfaction and reduce the risk of     post-operative complications.      The investigators hypothesize that the continuous use of a PEMF device for 48 hours after     Cesarean delivery will result in decreased post-operative pain scores on movement at 48     hours.   "
145255|NCT01383109|"     The combination of pyronaridine and artesunate is an antimalarial therapy in development.     This Mass Balance study is intended to determine the rate and extent of excretion of total     radioactivity in urine and faeces following administration of a single oral micro-dose of     14C-pyronaridine in humans.   "
145256|NCT01383096|"     This study is designed to assess prototype formulations compared to the aqueous dispersion of     Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped     that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that     observed when given after food. This will improve the utility of OZ439 in the field as well     as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very     important for an antimalarial drug product destined for use in developing counties.   "
145337|NCT01382043|"     The safety and efficacy of drug-eluting stents (DES) with a biocompatible polymer have been     demonstrated in randomized clinical trials as well as in real world practice. Theoretically,     a new DES with a biodegradable polymer should reduce the incidence of late in-stent     thrombosis, however, the long-term safety and efficacy of these stents remains unknown. This     study was aimed to compare the safety and efficacy of the Excel DES with a biodegradable     polymer to the Endeavor DES with a biocompatible polymer in same individuals.   "
145257|NCT01383083|"     The prevalence of PAH associated with congenital systemic-to-pulmonary shunts in Western     countries has been estimated to range between 1.6 and 12.5 cases per million adults, with     25-50% of this population affected by Eisenmenger's syndrome. The rarity of this syndrome,     combined with its complex pathophysiology, account for the insufficient understanding of the     principles underlying its proper treatment.Recent decades have seen developments in pulmonary     hypertension pathophysiology which have led to the introduction of new groups of drugs:     prostacycline analogs (Epoprostenol, Treprostinil, Beraprost, Illoprost), phosphodiesterase     inhibitors (Sildenafil, Tadalafil), endothelin receptor antagonists (Bosentan, Sitaxantan,     Ambrisentan) and nitric oxide. These drugs should be administered to patients in III-IV NYHA     class. Despite successful early results, the therapeutic effect on patients with Eisenmenger     syndrome has not been conclusively established The treatment strategy for patients with PAH     associated with congenital systemic-to-pulmonary shunts and, in particular, those with     Eisenmenger's syndrome is based mainly on clinical experience rather than being evidence     based. Although Eisenmenger's syndrome is uncurable disease, the survival rate is relatively     higher than primary PAH, and the patients with Eisenmenger's syndrome are relatively younger     group. So the improvement of exercise tolerance and quality of life is very important.     Several randomized controlled trial reported favourable short- and long-term outcomes of     treatment with the orally active dual endothelin receptor antagonist bosentan in patients     with Eisenmenger's syndrome. However, there was scare data of outcomes of treatment with the     inhaled iloprost in patients with Eisenmenger's syndrome. In Korea, most of patients with     Eisenmenger's syndrome are treated with conservative therapy instead of administration of     PAH-specific drug, because of lack of clinical experience. Moreover, oral agent such as     bosentan, sidenafil is preferred than iloprost becase of more evidence and convenience. Our     therapeutic efforts should be directed mainly towards preventing complications. As a rule, we     should avoid agents with no established therapeutic efficacy and try to alleviate symptoms     without any additional risk, so as not to disrupt the existing clinical balance.      In this study, we investigate to know the clinical benefit of iloprost on patients with     Eisenmenger's syndrome by the use of functional and hemodynamic parameters, which would add     the evidence of PAH-specific agents on the Eisenmenger's syndrome   "
145258|NCT01383070|"     Primary hypotheses      In a hospital-based CRCT, cell phone lactational counseling starting in the third trimester     of pregnancy to 24 weeks after delivery will improve the prevalence of EBF by 7.5 % (7.5%     increase in EBF by retraining in BFHI alone in both groups from baseline and a additional     7.5% improvement in intervention group as compared to the control) compared with women with     from hospitals with only retraining BFHI.      Secondary hypotheses As compared to women from hospitals receiving only retraining in BFHI,     those with additional cell phone lactational counseling will experience the following        -  Increase in the percentage of EBF(breast milk and no other foods or milk based liquids)          at 24 weeks after delivery,        -  Increase in the mean duration of any breastfeeding,        -  Increase in the percentage with TIBF,        -  Reduction in use of pre lacteal feeds        -  Reduction in percentage of infants being bottle fed(any liquid or semi-solid food from a          bottle with nipple/teat) any time before or at 24 weeks        -  Increase in the percentage of infants at 26 weeks after delivery who receive TICF,        -  Increase in growth velocity (weight, length and head circumference)        -  Reduction in the number hospitalizations or mortality in the mother-infant dyad till 26          weeks after delivery        -  Increase in adherence to visit schedules        -  Greater ratio of effectiveness as compared to costs incurred for cell phone counseling.   "
145259|NCT01383057|"     The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to     create a clear corneal incision during cataract surgery.   "
145260|NCT01383044|"     Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in     prophylaxis of the first bleeding. The efficacy & safety of combining EVL and carvedilol in     prophylaxis of the first bleeding is still unknown. This study aims to investigate the value     of combination therapy.   "
145261|NCT01383031|"     The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic     results of transumbilical laparoendoscopic single site cholecystectomy.   "
145262|NCT01383018|"     The purpose of this observational registry is to collect and better understand real-world     outcomes for men undergoing penile implant surgery to treat erectile dysfunction.   "
145263|NCT01383005|"     Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease     inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).      Since once-a-day dosing is actually a driver for human immunodeficiency virus (HIV)-infected     patients to request a specific antiretroviral, the aim of this study is to assess both     patient's perception of and adherence to Kaletra once-a-day, as well as with which factors     they are related.   "
145264|NCT01382992|"     EGFR mutations plays an essential role in EGFR-TKIs treatment. However, for some patients,     tissue samples are not available. The purpose of this study is to determine whether blood     sample is feasible for EGFR mutation detection.For late stage NSCLC, we hypothesis plasma     sample is an alternative for detecting EGFR mutations.   "
145265|NCT01382979|"     The study examined whether an online course for college freshmen (AlcoholEdu) had an effect     on alcohol misuse and related problems, using a randomized controlled design with 30     universities.   "
145277|NCT01382823|"     The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to     create a clear corneal incision during cataract surgery.   "
145266|NCT01382966|"     Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans,     was originally believed to be a non-classical Bone morphogenetic protein (BMP)     antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH)     signal transduction.      Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral     metabolism.New advances in the pathogenesis of renal osteodystrophy (ROD) change the     perspective from which many of its features and treatment are viewed. Calcium, phosphate,     parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of     survival associated with kidney diseases. Now ROD dependent and independent of these factors     is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an     underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the     elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the     view of ROD.      Emerging current data suggests a promising role for serum measurements of sclerostin in     addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients     (dialysis patients).      Because of the close relationship between ROD and cardiovascular disease, the aim of this     study is to investigate the association between sclerostin, arteriovenous fistula thrombosis,     echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients.   "
145338|NCT01382030|"     Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic     control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide,     ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An     additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed     by MRI and CT scans and FDG-PET in a subgroup of patients.   "
145267|NCT01382953|"     The purpose of this research is to simplify the standard recording system of the heart     rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24     hours. The investigators intent is to use a very small, innovative monitoring patch system     that relieves the patient of wearing a cumbersome and uncomfortable recording system. This     research trial will carry the title The Simple ECG Monitoring for Comparison of a Sternal     ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data     from the investigational device is for comparative purposes only. It will not be used by     medical personnel for study subject treatment or diagnostic purposes.   "
145268|NCT01382940|"     This study was designed to evaluate the safety of administering rituximab at a more rapid     infusion rate in patients with moderate to severe rheumatoid arthritis who have had an     inadequate response to biopharmaceuticals that treat diseases by interfering with tumor     necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than     eight weeks.   "
145269|NCT01382927|"     General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation,     especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In     this study, the investigators are comaparing obese patients undergoing hip arthroplasty in GA     versus spinal anesthesia. Distribution of ventilation during and after anesthesia is assessed     by eletrical impedance tomography (EIT).   "
145270|NCT01382914|"     The purpose of this study is to daily monitor the discoloration of teeth when participants     rinse with a mouth rinse and black tea and to determine the time point when unacceptable     discoloration occurs.   "
145271|NCT01382901|"     The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV)     iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs     Syndrome (RLS)   "
145272|NCT01382888|"     The primary objective of this study is to evaluate the effect of topically applied heparin in     comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in     patients planned for haemodialysis at 7th week (± 1 week) after first study drug     administration.   "
145273|NCT01382875|"     Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and     account for 12% of the disease burden in elderly aged 65 or above.      A good management healthcare program and training helps elderly to restore full functional     level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong     lacks of such program. Some reports from other countries pointed out a well-organized     multi-disciplinary management programs are cost-effective to identify and treat osteoporosis,     reduce the fracture rate, improve quality of life and raise awareness of fragility fracture.      This study aims to compare the cost-effectiveness of multi-disciplinary management program     with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall     rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility     hip fracture patients in New Territories East receiving the proposed management program will     be compared with those from Kowloon Central with usual care as controls. The findings will     provide useful data for the policy maker to evaluate the current clinical service for     fragility fracture patients and consider the implementation of new multi-disciplinary     management program into our healthcare system.   "
145274|NCT01382862|"     The purpose of this prospective study in acute ischemic stroke patients is to compare     alarm-to-needle time during randomly allocated periods with and without availability of a     specially staffed ambulance equipped with computed tomography (CT) and point-of care     diagnostics. The investigators hypothesize that compared to regular care the investigators     will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke     emergency mobile unit.   "
145275|NCT01382849|"     Florbetapir F 18 is an experimental radioactive drug that may allow doctors to image changes     in the brain using a PET (Positron Emission Tomography) scanner. The purpose of this study is     to evaluate the imaging characteristics of, Florbetapir F 18 (also known as 18F-AV-45) in     patients who have previously undergone bleeding in their brains. Florbetapir F 18 binds to     amyloid-ß peptide (Aß) that accumulates in the brains of patients with bleeding. These     accumulations are called amyloid plaques and when extensive are labeled cerebral amyloid     angiopathy (CAA). Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low     level of gamma rays which can be detected by a PET camera.      MRI detected microbleeds have been identified as markers of clinically silent hemorrhage from     bleeding-prone vessels. Another imaging marker of vessel damage and risk of bleeding is the     spot sign (SS). Finally, certain genetic signatures (ApoE genotype) have been shown to be     associated with Aß deposition in the brain or predispose patients to higher risks of     bleeding. This research study will explore the interactions of these factors and understand     the physiology of intracerebral bleeding.   "
145276|NCT01382836|"     As part of ongoing efforts to determine the causes of asthma and the progression of the     disease, this study will gather data to explore the interaction of genetic and environmental     factors in the cause and severity of asthma in inner city children.   "
145280|NCT01382784|"     There is growing evidence that psoriasis is a systemic disorder which enhances     atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an     independent association between psoriasis and atherosclerosis, stroke and coronary artery     disease. The main goal of this on-going study is to register data which will enable the     identification of new markers of atherosclerosis activity and carotid plaque instability in     patients with severe psoriasis.   "
145281|NCT01382771|"     Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment     and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who     have failed conservative therapy including physical therapy, have had an initial >80% pain     relief on a diagnostic medial branch block, and are scheduled to undergo a routine second     medial branch block for facet mediated pain will be randomized. Both groups will receive the     standard of care, a medial branch block. The treatment group will also receive one set of     intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive     intra-articular normal saline.   "
145423|NCT01381055|"     The purpose of this study is to determine whether pentoxifylline associated to pentavalent     antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous     leishmaniasis.   "
145282|NCT01382758|"     One in a hundred children is born with a heart defect. Some children require heart surgery     within the first few days of life, while others can wait until they are older. A complication     of open-heart surgery is low blood flow due to the heart-lung machine that can cause sudden     loss of kidney function known as acute kidney injury (AKI). AKI causes complications that can     increase hospital length of stay and increase risk of death. Current ways to identify AKI are     not able to it until 2 or 3 days after it has occurred. Because of this, there is not a     specific treatment for AKI. If the investigators diagnose AKI early, they might be able to     treat it and improve outcomes in children. NIRS is a skin monitor that can detect low blood     flow to the kidney and might help diagnose AKI when it occurs in the operating room. The use     of NIRS to diagnose AKI early is the focus of this study.   "
145283|NCT01382745|"     The objective of this study is to demonstrate the feasibility of using Nimotuzumab and     radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve     a 65% local control rate with a better toxicity profile than the conventional treatment.     Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this     study.   "
145284|NCT01382732|"     Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients     with severe preeclampsia there is an increased risk of postpartum hemorrhage but the     hemodynamic changes associated with this pathology make the management of any kind of     bleeding particularly troublesome. There are many pharmacological options, being oxytocin the     first line of treatment. However there is no evidence about the safety and efficacy of     carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin     for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.   "
145285|NCT01382719|"     This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of     bremelanotide, administered subcutaneously on an as-needed basis under conditions of home     use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire     disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.   "
145286|NCT01382706|"     This phase II trial studies how well giving docetaxel and lapatinib ditosylate together as     second-line therapy works in treating patients with stage IV bladder cancer that cannot be     removed by surgery. Drugs used in chemotherapy, such as docetaxel, work in different ways to     stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the     enzymes needed for cell growth. Giving docetaxel and lapatinib ditosylate together may kill     more tumor cells.   "
145287|NCT01382693|"     This project, a small-scale pilot study, will attempt to determine if involvement in a     group-based creative expression program may correlate with a reduction in use of psychotropic     drugs for persons with dementia.   "
145288|NCT01382680|"     In ERCP practice, most often a combined use of guidewires is necessary to attain a     therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a     stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new     guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip.     The investigators test the hypothesis that the use of this new guidewire would decrease     number of guidewires used within one ERCP session.   "
145289|NCT01382667|"     The specific aim of the study is to investigate the relationship between the development of     dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides     (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well     controlled for emesis.   "
145290|NCT01382654|"     The objectives of this study were to:        -  Examine the tolerability of two formulations and two dose concentrations of epinastine.        -  Select formulation(s) of epinastine for future studies by evaluating the individual          sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected          after each study drug administration and the subject preference ranking assessed at the          completion of the study.        -  Compare the preference of two formulations and two dose concentrations of epinastine          compared to azelastine following a single dose of each in a randomized, double-blind,          two-cohort, three-period crossover design.   "
145291|NCT01382641|"     The doctors participating in this study are looking to show improved vision with the HOYA     AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of     Revital Vision (neuro-sensory testing) in providing the highest potential for improved     vision.   "
145292|NCT01382628|"     This is a pilot study examining tendon collagen, collagen cross-linking, and markers of     tendon extracellular matrix metabolism in the Achilles tendon of diabetic patients with     ulcerations and amputations of the lower extremity.   "
145293|NCT01382615|"     The purpose of this study is to collect a blood or bone marrow sample from patients with     multiple myeloma and from volunteers without myeloma.   "
145294|NCT01382602|"     This is a clinical trial is to study the safety and effectiveness of autologous     muscle-derived cells (AMDC) for the treatment of female stress urinary incontinence (SUI).   "
145295|NCT01382589|"     The purpose of this study is to determine whether afamelanotide and narrow band UVB are     effective in the treatment of non-segmental vitiligo (NSV).   "
145299|NCT01382537|"     This study will focus on the efficacy of treating 80 patients who have functional limitations     in activity because of chronic/recurrent neck or shoulder pain.      Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks     1-2.      Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared     to those who received placebo treatment.      Hypothesis 3: Chronic neck and shoulder pain is more prevalent in patients who exhibit     radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.   "
145346|NCT01381926|"     The purpose of this study is to determine changes in bone turnover markers and calcitonin     following the initiation of exenatide compared to placebo in postmenopausal women wtih type 2     diabetes.      Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline     phosphatase) will be lower and bone formation (measured by type I collagen crosslinked     aminoterminal peptide in urine (Urine NTX)) will be higher when subjects are treated with     exenatide compared to when subjects are treated with placebo.      Hypothesis 1b: Calcitonin levels will not vary significantly between periods of treatment     with exenatide vs. placebo.   "
145300|NCT01382524|"     Approximately 300 million short peripheral intravascular catheters (PIVs) were sold in the     U.S. in 2009. These short (< 3 inches) peripherally inserted IV catheters are vital for     providing patients with needed: 1) fluid, electrolyte, nutrient and blood product     replacement, 2) medicines and 3) diagnostic solutions (dyes). However, these IV catheters     have inherent risks or potential complications which may result from poor catheter securement     or stabilization.      When a PIV catheter is not properly secured, motion and micro-motion within the vessel cause     injury to the vein. This damage to the vein is a primary cause of phlebitis, a distressing     complication of PIV therapy. Additional complications of inadequate stabilization of the PIV     catheter are infiltration, leaking at the insertion site, pain, infection and dislodgement.     According to Royer (2003), the most common reason for PIV catheter failure is infiltration     and dislodgement. Infiltration is more dependent on keeping the extremity still, where     phlebitis is dependent on injuries due to the chemical nature of the drugs and fluids infused     or by the physical trauma to the endothelium from IV pushes.      The results of these complications are costly and can be serious if another vein cannot be     immediately accessed or if the infiltrated infusate causes tissue necrosis. An unscheduled     restart of another PIV catheter causes a delay in patient treatment, patient discomfort,     patient dissatisfaction, safety concerns, nursing interruptions and additional costs. Actual     costs associated with PIV catheter restarts include materials and nursing resources; yet     intangibles such as, treatment for patient complications and patient dissatisfaction may be     far more costly.      One way to reduce the incidence of PIV catheter-associated complications is to use     technologies that help reduce catheter movement thereby improving catheter stabilization. In     addition to stabilization platforms added to the peripheral IV catheter design, catheter     stabilization devices and modified transparent film dressings also help to reduce catheter     movement and could possibly eliminate the need for routine catheter site changes.      Therefore, the purpose of this study is to: 1) compare the number of PIV securement-related     complications and PIV catheter restarts of one stabilization system to another stabilization     system and 2) to determine which system provides a cost savings.   "
145301|NCT01382511|"     Simvastatin and related statins, such as compactin, are able to inhibit the constitutive     expression of inducible/repressible keratin genes such as K6a and K17. This effect is due to     the reported ability of statins to inhibit STAT1 expression (Lee et al., 2007). The     constitutive K6a promoter activity is dependent on STAT1 and blocked by simvastatin or siRNA     against STAT1. This STAT1-dependent constitutive expression of K6a, is independent of JAK     (Janus family of kinases).      Thus simvastatin is capable of down-regulating both the constitutive and interferon-inducible     expression of PC-related keratins such as K6a and K17. Therefore, this class of molecule has     potential for the treatment of PC or related inherited disorders where the causative mutation     resides in an inducible/repressible keratin gene such as K6a or K17.      Simvastatin or other statins approved for human use might be delivered either orally, as is     currently the case for cholesterol-lowering treatment or, if higher therapeutic doses are     required in skin for reduction of hyperkeratosis in PC or in related keratinizing disorders,     this might be achieved by topical formulations.   "
145302|NCT01382498|"     Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2     diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of     diabetic retinopathy showing a slowdown of the progression of the disease after long-term     oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent     vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the     failure of autoregulation that it is an important and often early feature of diabetic     retinopathy.several studies have been confirmed that inflammation besides oxidative stress     are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in     detecting inflammation in these patients. The aim of this study was to determine the effects     of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.   "
145303|NCT01382485|"     The specific question the investigators will seek to answer is: can the Reamer Irrigator     Aspirator (RIA) provide a bone graft source for the treatment of nonunions that is equally     effective to Autogenous Iliac Crest Bone Graft (AICBG) while resulting in a decreased amount     of post-operative pain and a lower rate of complications?   "
145304|NCT01382472|"     In this mechanistic pilot study in 40 patients the investigators will compare the findings in     patients treated with very early high dose statin therapy with historic controls from the     KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose     statin therapy in patients treated with primary PCI:        1. reduces area of myocardial infarction, reduces volumes and improves remodelling as          assessed by MRI at 2 days and at 2 months        2. improves microcirculation (Decreased number of patients with MO) as assessed by first          pass time estimated with MRI 2 days        3. have impact on coronary blood flow as assessed by intravascular registrations and TIMI          frame count immediately after PCI        4. reduce levels of CK-MB and TnT measured as area under the curve during the hospital stay          at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and          neurohormones at discharge and at 2 months follow-up        5. improves endothelial function assessed by flow mediated vasodilatation at discharge        6. alters Peak VO2 at 1 and 6 month        7. reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at          follow-up alters collagen turnover   "
145305|NCT01382459|"     The investigators assume that an intervention program that includes home visits and trainings     of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic     balance, a decrease in complications' rate, a reduction of hospitalizations and an economic     streamlining.   "
145306|NCT01382446|"     Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol     for trauma patients on ventilator support to decrease the incidence of Ventilator Associated     Pneumonia and oral bacterial load.   "
145332|NCT01382108|"     The purpose of this study is to look at both the meibomian glands and the tear film using a     new clinical instrument marketed in Canada which was recently acquired by the Centre for     Contact Lens Research. These will be compared between two groups of individuals, one group     with visible meibomian gland dysfunction (MGD) and one group of individuals with normal     meibomian gland appearance. The hypothesis is that there will be a difference between normal     individuals and individuals with MGD with respect to the appearance of the meibomian glands     and certain tear film attributes.   "
145333|NCT01382095|"     The purpose of the study is to determine if immunization with a recombinant E. coli protein,     dscCfaE, is safe and immunogenic when administered through the skin using a patch.   "
145347|NCT01381913|"     Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor     prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed     in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor     control compared with NAC. This feasibility trial explored the feasibility and safety of     neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.   "
145307|NCT01382433|"     The aim of the current study is set out to find a human model for negative symptoms based on     clinical observation that chronic cannabis users express negative symptoms and characterize     by the same neurocognitive and electrophysiology characteristics like patient suffer from     schizophrenia. Towards that end the first part of the study is set out to explore weather     chronic cannabis user's express negative symptoms similar to patient suffer from     schizophrenia. The second part of the study will explore the neurocognitive and     electrophysiology characteristics of those cannabis users that express negative symptoms.     This data will be compared to parallel data of schizophrenia patients with predominantly     negative symptom.      Several lines of biological and genetic evidence support the cannabinoid hypothesis for     schizophrenia. Particularly, it is most significant clinically that the possible involvement     of the cannabinoid system in the neural basis for the negative symptoms. This hypothesis     based on clinical findings that chronic cannabis use causes a combination of symptoms     including apathy, avolition, lack of interest, passivity, and cognitive impairments, the     so-called amotivational syndrome, which resembles the core negative symptoms of     schizophrenia in behavioral level as well as the brain level. Both are associated with the     functions or integrity of the frontal lobe due to its role in creating self-directed     behaviors, deficits in which may underlie alogia, anhedonia, and flat affect. Despite the     aforementioned similarities, to date, there is no documentation for such a relationship.     Recognition that chronic cannabis users share the same or similar constellation of symptoms     and similar neurocognitive and electrophysiology characteristics could provide a key to     develop a human model for negative symptoms and an essential tool to comprehensive     understanding of the etiology of negative symptoms and development of an innovative therapy.      The investigators Hypothesize That Chronic Cannabis Users Would Express the Same     Constellation of Behaviors as Negative Symptoms of Schizophrenia; as well as similar     neurocognitive and electrophysiology characteristics   "
145308|NCT01382420|"     Objective:      To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of     adrenal incidentaloma.      Methods:      234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two     groups(e.g adrenalectomy group and conservative treatment group).   "
145309|NCT01382407|"     The hypothesis of this study is that patients who suffered from acne vulgaris during     adolescence are at greater risk of developing acneiform skin rash due to cetuximab.   "
145310|NCT01382394|"     Brain natriuretic peptide (BNP) is involved in the regulation of blood pressure and fluid     volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to     the emergency room with dyspnea. Interleukin-6 (IL-6) is a cytokine marker of inflammation     that exhibits significant prognostic value in predicting severity and outcome of sepsis.     Recently, it was suggested that inflammatory cytokines play an important role in the     development of heart failure. Procalcitonin (PCT) is a propeptide of calcitonin which is     normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT     remain very low, a dramatic increase in serum PCT levels is observed during severe systemic     infections. These properties make procalcitonin less useful for the diagnosis of simple     infections but a very promising marker of severe infections especially in the critical care     setting.      To investigate the co-relation between BNP, IL-6 and procalcitonin in two groups of patients;     those presenting with the diagnosis of decompensated heart failure and in patients presenting     with the diagnosis of sepsis without cardiovascular or hemodynamic dysfunction.   "
145311|NCT01382381|"     The goal of the study is to evaluate long term durability and hemodynamic effect of implanted     stents in the aortic arch and in pulmonary artery branches.   "
145312|NCT01382368|"     -  Pulmonary diseases are increasingly important causes of morbidity and mortality in the          modern world.        -  Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets          the nitric oxide (NO) pathway. The drug was first approved for the treatment of          Pulmonary Arterial Hypertension (PAH) in 2005.        -  The aim of the suggested study is to examine the acute effect of oral intake of          sildenafil on exercise tolerance and functional capacity in Chronic Obstructive          Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy          patients.        -  The investigators hypothesize that oral ingestion of sildenafil prior the exercise may          enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy          patients.        -  Patients and Methods:      Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD     III-IV) [9, 39] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study.        -  All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on          bicycle ergometer in different days; 60 min after intake of placebo and 60 min after          intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order.        -  In first meeting prior exercise test at rest standard pulmonary function test, diffusion          of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and blood          samples for NT-proBNP will be taken prior and post each CPET.        -  After 15-20 minute of passive recovery post exercise test all patients will perform 3          short functional tests including 6 minute walk test to assess functional capacity.   "
145313|NCT01382355|"     Advances in transplant pharmacotherapy have led to improved one-year patient and graft     survival in kidney transplant recipients, but have not translated to enhanced long-term     survival. An explanation for the disparity in outcomes is the negative role of antibodies in     transplant graft survival. There currently does not exist maintenance immunosuppression that     targets antibodies and standard of practice aims at removing circulating donor specific     antibodies upon detection of antibody mediated graft damage but not prior to the detection of     rejection. There exists an insufficiency of data regarding patient and donor characteristics,     changes in immunosuppression, the risk of viral donor and patient seropositivity and the risk     of non-compliance on the development of antibodies. By measuring antibody levels in the blood     at specific time periods after transplant, we may have a better understanding of what types     of patients will develop antibodies, when these antibodies appear and how changes to     transplant medications may affect antibodies.      The proposed project will examine the multifactorial risks associated with the development     and appearance of donor-specific antibodies in the first year post-kidney transplant. The     data collected will provide a historical perspective and preliminary pilot data to support a     proposal for prospective antibody monitoring and to justify pre-emptively treating the     antibodies in the absence of clinical signs of rejection.   "
145334|NCT01382082|"     Cognitive impairments in cancer patients represent an important clinical problem. Studies to     date estimating prevalence of difficulties in memory, executive function, and attention     deficits have been limited by small sample sizes and many have lacked healthy control groups.     More information is needed on promising biomarkers and allelic variants that may help to     determine the etiology of impairment, identify those most vulnerable to impairment, and     develop interventions for these difficulties.      This is a longitudinal observational study of cognitive function in breast cancer and     lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive     difficulties (i.e., problems with memory, executive function, and attention) in these     populations.   "
145314|NCT01382342|"     While Parkinson's disease has historically been defined in terms of its motor symptomatology,     studies have shown that non-motor deficits form an important part of the syndrome. Cognitive     deficits can occur even in the early stages of Parkinson's disease. These deficits are often     subtle and do not rise to the level of impairment necessary for a diagnosis of dementia;     however these deficits are discernable with neuropsychological testing and may produce     subjective complaints of cognitive decline and mild functional difficulties in some patients.     The traditional pharmacological interventions for Parkinson's disease have focused on     controlling and alleviating motor symptoms with levodopa and dopamine agonists. However,     these medications treat the symptoms of PD, but do not alter the course or progression of the     underlying disorder. In contrast, rasagiline, an MAO-B inhibitor, has recently shown benefits     consistent with a possible disease-modifying effect. Given the positive and intriguing     findings seen with treatment with rasagiline, the investigators propose to study the effects     of this medication on cognition in patients with mild to moderate stage Parkinson's disease.      Hypotheses:        1. Rasagiline will improve cognitive function, as measured by performance on          neuropsychological tests in PD patients who do not suffer from dementia.        2. Rasagiline will not negatively affect neuropsychiatric functioning.   "
145315|NCT01382329|"     The purpose of this study is to obtain immunogenicity and safety data of two different dose     levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18     to 59 years.   "
145316|NCT01382316|"     This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a     manual-guided intervention designed to help alcohol and drug dependent clients connect with     individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was     determined by comparing abstinence rates of participants recruited during ON (MAAEZ     intervention) and OFF (usual care) conditions and by studying the effect of the number of     MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12     months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from     alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ     session received. MAAEZ appeared especially effective for those with more prior AA exposure,     severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ     (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having     a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents an     evidence-based intervention that is easily implemented in existing treatment programs.   "
145317|NCT01382303|"     This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline     on proteinuria in Korean type 2 diabetic patients.   "
145318|NCT01382290|"     Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established method     for detecting acute injury to the brain and is used on all children undergoing an MRI brain     scan at Children's Healthcare of Atlanta. The possibility of using DW MRI to study other     areas of the body, such as the spinal cord, has been recognised as having great clinical     potential. However, two main problems have hindered the clinical application of the     technique; firstly, the extreme motion sensitivity of the technique meant that respiratory     motion have hampered clinical studies. Secondly, the close proximity of the spinal cord to     the bones in the spinal column complicates the application of the techniques developed for     the brain to the spine. Recently, several techniques have been developed which address these     problems and these are now available on the MRI scanners used at Children's Healthcare of     Atlanta.      We now wish to evaluate how well these techniques work on children in a routine clinical     setting. For this reason we wish to add a single scan of the spine to the imaging protocol of     children receiving a routine scan of the brain or spine. This will permit us to evaluate the     image quality in both normal and abnormal spines. We plan on enrolling 60 patients with     normal spines and 30 patients with abnormal spines. No additional sedation and/or contrast     will be required and the additional imaging time for the diffusion studies will be less than     10 minutes. Parental consent will be a pre-requisite for any patient to be enrolled into the     study.   "
145319|NCT01382277|"     This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20     mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart     disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice     spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also     evaluated.   "
145320|NCT01382264|"     The primary purpose of this study is to determine whether the use of a computer assisted     decision support (CADS)system by primary care providers (PCPs) for their patients with type 2     diabetes mellitus (T2DM) changes the quality of care relative to a usual care group in     terms of objective outcome measures of glycemic control (e.g., A1C, mean blood glucose,     frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.   "
145321|NCT01382251|"     The purpose of this study is to assess the functional recovery of older ambulatory surgical     patients and the impact of the current model of care on the caregivers of these patients.     This study will provide unique insight into the challenges patients and their families face     following surgery.      The primary objective of this study is to:        1. Assess the impact of ambulatory surgery on functional capacity as assessed by the          Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following          surgery in a population of surgical patients 65 years of age and older.           Secondary objectives are to determine if:        2. Changes in the patient's functional capacity result in increased burden of care as          assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.        3. Changes in functional capacity are correlated with decrements in quality of life as          assessed by the Short Form 12 (SF12).        4. Changes in functional capacity are correlated with inadequate postoperative analgesia as          assessed by the Brief Pain Inventory (BPI).   "
145335|NCT01382069|"     The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU)     as a male hormonal contraceptive.      The study has two parts. The first is a dose escalating study in healthy to assess the safety     and tolerability of single dose oral administration of DMAUin healthy men.(Completed)      The second is to study the safety and tolerability of DMAU after 28 days of repeated daily     dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will     also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral     administration of DMAU.   "
145322|NCT01382238|"     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials     for the treatment of human immunodeficiency virus (HIV) infection. A granule formulation has     been developed as an alternative to the current tablet formulation for administration in     pediatric populations.      This is a single-center, randomized, open-label, 5-way crossover study in healthy adult     subjects. The study will evaluate the relative bioavailability of a 50 mg granule formulation     of dolutegravir when administered 1) directly to mouth; 2) with purified water; 3) with     Contrex brand water; and 4) with milk-based infant formula compared to the current 50 mg     tablet formulation administered with tap water. Safety evaluations and serial PK samples will     be collected during each treatment period. A taste assessment of the granule will also be     performed. A follow-up visit will occur 5-7 days after the last dose of study drug.      Pharmacokinetic assessments during the study will include area under the concentration-time     curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)), area under     the concentration-time curve from time zero (pre-dose) to last time of quantifiable     concentration within a subject across all treatments (AUC(0-t)), maximum observed     concentration (Cmax), terminal phase half-life (t½), lag time before observation of drug     concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), concentration at     24 hours post-dose (C24), and apparent clearance following oral dosing (CL/F).   "
145323|NCT01382225|"     The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in     treating the signs and symptoms of dry eye disease.   "
145324|NCT01382212|"     The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages     10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal     dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will     be in the dosing period of the study for 12 weeks in order to evaluate the incidence of     hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and     all 12 will receive paricalcitol capsules.   "
145325|NCT01382199|"     The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human     Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult     Patients.   "
145326|NCT01382186|"     Deployment of Secure Messaging (SM) in primary care and women's clinics throughout the     Veteran Health System by 2011 was an implementation priority for the Secretary and Under     Secretary for Health for FY11 under the VHA T21 initiative. Secure Messaging is in early     phases of implementation, this eHealth tool requires thoughtful evaluation to promote the     successful implementation and dissemination of this tool. The primary aim of this project is     to describe Veterans' experiences when using the SM feature on MyHealtheVet (MHV). This     project has local, VISN, and national impact on the implementation and sustainability of the     SM feature on MHV through its qualitative and quantitative examination of users' experiences.     Findings from this research explores why Veterans choose to, or not to, use the SM feature on     MHV, identify facilitators and barriers, and examine if experiences differ by health literacy     or computer literacy. In addition to the interview data, findings from the usability testing     and the quantitative survey findings build knowledge about Veterans' experiences using the SM     feature on MyHealtheVet. These data will inform systems improvements, educational approaches,     and marketing strategies to increase adoption and long-term utilization among Veterans.   "
145327|NCT01382173|"     Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes,     the overall aim of this study is to investigate structural injuries and biochemical     alterations in the acutely injured knee and to relate these findings to clinical outcomes at     various time points.   "
145328|NCT01382160|"     Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α)     approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs     (DMARDs) and for the treatment of severe, active and progressive RA in adults not previously     treated with methotrexate.      However, almost one third of patients have no response and approximately 15% develop     antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a     relationship between adalimumab concentration and clinical response obtained after 6 month of     treatment. Furthermore adalimumab concentration measured 3 months after initiation seems to     predict the clinical response at 6 months.      There is an important inter individual pharmacokinetic variability of adalimumab. Side     effects may occur at the recommended dose and more than 3 months of treatment are generally     required to estimate the clinical response.      A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the     response and to avoid dose related side effects. To date there is no definite adalimumab     target concentration predictive of the clinical response to allow such a pharmacologic     monitoring.   "
145329|NCT01382147|"     Evaluation weather early chemotherapy attempts for remission induction can improve the     results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.   "
145330|NCT01382134|"     Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of     aspirin, hemodilution and mild hypothermia      Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to     increased surgical bleeding and increased transfusion requirement during surgery. Although     this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is     not always possible or desirable.      Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in     uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a recent     study, we have found that subcutaneous injection of 1.5 mcg (1/10th the usual dose) is     already sufficient to fully reverse the platelet dysfunction seen at 32oC. We have     demonstrated in another study that prolongation of the bleeding time in a 20% hemodiluted     sample predicts increased postoperative bleeding after total knee replacement.      We have therefore designed this study as a follow up to our last two studies on DDAVP and     hypothermia, to investigate whether hemodilution affects hypothermia induced platelet     dysfunction and the response to DDAVP. In addition, another common cause of perioperative     platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients.     Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response     to DDAVP, will also be investigated.   "
145331|NCT01382121|"     The purpose of this study is to implement a peer modeling intervention to improve     self-efficacy and aerobic fitness in obese youth. A total of 40 obese (defined as Body Mass     Index greater than the 95th percentile for age and gender) youth will participate in this     study.   "
145339|NCT01382017|"     This study has been designed to explore dose-depended effects of lacosamide (LCM) on motor     cortex excitability with TMS in a randomized, double-blind, placebo-controlled crossover     trial in young healthy human subjects, and to compare the pattern of excitability changes     induced by LCM with those of carbamazepine (CBZ). LCM selectively enhances slow inactivation     of voltage-gated sodium channel, and, in contrast to CBZ, does not affect steady-state fast     inactivation (Errington et al., 2006). The enhancement of slow inactivation of sodium     channels by LCM is a novel manner to modulate sodium channels and leads to normalization of     activation thresholds and a reduced pathophysiological hyper-responsiveness, thereby     effectively controlling neuronal hyperexcitability without affecting physiological activity     (Beyreuther et al., 2007). Therefore, it is thought that LCM, compared to CBZ, will be better     tolerated in clinical settings while being as or even more effective in controlling seizure     activity. On the basis of the results from nonhuman studies, it is hypothesized that the TMS     profile of LCM will be distinguishable from that of CBZ. CBZ, like other 'classical' sodium     channel blockers such as phenytoin, predominantly demonstrated elevated TMS motor thresholds     indicating reduced neuronal membrane excitability, without developing significant changes of     synaptic intracortical inhibition and facilitation (Ziemann et al., 1996; Chen et al., 1997;     Lee et al., 2005). Because of its novel mode of action it can only be speculated which TMS     parameters LCM might affect. For example, more than exclusively affecting neuronal membrane     excitability, LCM could possibly also affect inhibitory mechanisms such as short- and     long-latency intracortical inhibition (Valls-Sole et al., 1992; Kujirai et al., 1993). This     would in line with other well-tolerated modern antiepileptic drugs (Ziemann et al., 1996;     Reis et al., 2002; Lang et al., 2006).   "
145340|NCT01382004|"     Yaws, an endemic treponematosis and as such a neglected tropical disease (NTD), is currently     making a comeback in children in rural areas. Injectable long acting penicillin remains the     drug of choice for the treatment of yaws. However, on the basis of successful experience with     venereal syphilis in large-scale studies, oral azithromycin has emerged as a potential     alternative that overcomes the major medical and logistic disadvantages of the current     regimen.      In this non-inferiority randomized clinical trial the investigators propose a comparable     scheme for the treatment of yaws, to test the efficacy of a single, oral dose of azithromycin     versus a single, i.m. dose of benzathine penicillin G.Sample size has been calculated to     detect a non-inferiority margin of 10%. Children < 15 years of age with a confirmed diagnosis     of yaws will be randomly assigned to receive 30mg/Kg (maximum 2g) of azithromycin orally or     50.000units/Kg (maximum 2.4MU) of penicillin-G-benzathine intramuscularly. The primary     outcome is treatment efficacy, with cure defined serologically (a decline in the VDRL titer     of at least two dilutions by six months after treatment) and, in primary yaws, also by     epithelialization of ulcers within two weeks.   "
145341|NCT01381991|"     Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal     reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be     assessed. However, there were some limitation in diagnosis of GERD using endoscopy        1. More than half of patients with GERD reveal no visible abnormality on conventional          endoscopy, it is possible that minute mucosal changes are underestimated by conventional          endoscopy due to the limitation of visual ability        2. In addition of uncertainty in detecting mucosal breaks, uncertainty in describing          severity of mucosal injury can lead to inconsistency among interpreters. Interobserver          agreement regarding diagnosis and classification of GERD using endoscopy is          unsatisfactory to apply daily practice.      Thus, the development of a new method to define the intra-esophageal injury for use in daily     practice is a worthwhile endeavor and developed, such as narrow−band imaging (NBI), Fuji     Intelligent Chromoen−doscopy (FICE) and i-scan.      Among them, i-scan technology is the most recently developed image enhancing technology,     which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast     enhancement (CE), and tone enhancement (TE).      Thus, the investigators examined the hypothesis that i-scan can improve the detection rate of     reflux esophagitis and inter-observer agreement between endoscopists compared with     conventional white light (WL) endoscopic examination.   "
145342|NCT01381978|"     Hypothesis: Obesity in children of Cuenca is related with socioeconomical status and physical     activity habits.      Summary:      The prevalence of obesity and overweigh in all age groups are increasing rapidly in the     world. Some factors like physical activity, socioeconomical status, dietary habits, gender,     besides genetic factors influence in the development of obesity.      In Cuenca - Ecuador lack information related to prevalence of overweight and obesity in     children and the risk factors related.      Socioeconomical status and quality of physical activity are assessed using specially designed     questionnaires in a randomized sample of children 6 to 9 years of age of Cuenca city.     Nutritional status is assessed using body mass index, relation weight/age and height/age.     These data are helpful to develop programs focused to improve nutritional status in scholars     of Cuenca.   "
145343|NCT01381965|"     Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the     repair of photoreceptor cone outer segment tips defect is significantly correlated with the     visual outcomes after macular hole surgery.   "
145344|NCT01381952|"     ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise     reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose     significantly. This is realized by anatomy-specific optimization of the full acquisition     chain (grid switch, beam filtering, pulse width, spot size, detector and image processing     engine) for every clinical task individually. Furthermore, smaller focal spot sizes and     shorter pulses are used, which are known to positively influence image quality . The final     effect on the clinical image quality is investigated in this study.   "
145383|NCT01381575|"     This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals'     HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and     0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule     (0,1,6 months) in 15-25 year old females.   "
145345|NCT01381939|"     Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common     procedure in management of ICP to avoid fetal complications. Surprisingly, this empirical     approach has not been evaluated as to delivery complications and fetal outcome as yet. The     investigators now examine weather ICP affects (i) delivery procedures chosen, in particular     the incidence of caesarian section, (ii)fetal and maternal outcome in induced labor, and     (iii)possible impact of bile acids and UDCA treatment in a retrospective cohort study based     on approximately 5000 induced deliveries at Danderyd Hospital, Karolinska Institutet,     Stockholm. The investigators analyze data on on previous deliveries, BMI, medical history and     medical book data. Primary endpoint is the risk of caesarian section.   "
145348|NCT01381900|"     The purpose of this study is to assess the safety, tolerability, and efficacy of the addition     of canagliflozin relative to the addition of placebo in patients with inadequate glycemic     control on metformin alone or in combination with a sulphonylurea.   "
145353|NCT01381835|"     The purpose of this study is to assess the steady-state pharmacokinetics of TMC435 in     participants with severe renal impairment and to compare these with the TMC435     pharmacokinetics in matched participants with normal renal function. We will also study the     short-term safety and tolerability of TMC435, when administered in participants with severe     renal impairment and in participants with normal renal function. Steady-state is a term that     means that the drug has been given long enough so that the plasma concentrations will remain     the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic     hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into     the bloodstream, distributed in the body, and eliminated from the body.   "
145354|NCT01381822|"     The primary objectives are:      Dose escalation:      1. To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib.      Dose expansion:        1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib          as determined by the response rate and the progression-free survival in subjects with          advanced RCC treated at the RP2D        2. To assess the safety of TH-302 in combination with sunitinib and determine a recommended          Phase 2 dose of the combination.      The secondary objectives are:      Dose expansion:      1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib     as determined by stable disease or better rate, duration of response and overall survival in     subjects with advanced RCC treated at the RP2D.      The exploratory objective is:      1. To explore the association of serum hypoxia biomarkers with efficacy endpoints.   "
145355|NCT01381809|"     The purpose of this study is to demonstrate that epoetin alfa works better than placebo in     improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of     epoetin alfa will also be evaluated.   "
145356|NCT01381796|"     The purpose of this research is to:        1. Compare two study patches having minor differences in patch components        2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates          medication) of NP101 (study patches) versus a currently approved oral formulation of          Imitrex        3. Collect resistance data during application of NP101 (study patch)   "
145357|NCT01380821|"     Ionizing radiation has a number of harmful effects in humans. The most important among these     is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell     can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks     (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.      The investigators are already conducting several other studies to prospectively compare the     inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending     these examinations to investigate the induced DSBs by myocardial scintigraphy allows a     comparison of all three relevant imaging methods of the heart that incorporate ionizing     radiation.      To evaluate this, the investigators are planning to examine patients who are scheduled for a     clinically indicated myocardial scintigraphy. These examinations are routinely done by the     Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the     diagnostic reference values of the Federal Department for Radiological Protection. Blood     samples will be taken from these patients at predefined time steps before and after the     examination and DNA double-strand breaks will be determined from these blood samples     specifically considering the applied activity of the tracer and the exposition kinetics.   "
145360|NCT01380782|"     BIBF 1120 is a newly discovered compound that may stop cancer cells from growing abnormally.     This drug is currently being used in treatment for other cancers in research studies and     information from those other research studies suggests that this agent, BIBF 1120, may help     to stop recurrent malignant glioma cells from multiplying and it may also prevent the growth     of new blood vessels at the site of the tumor. In this research study, the investigators are     looking to see how well BIBF 1120 works in patients with recurrent malignant gliomas.   "
145361|NCT01380769|"     The purpose of this study is to compare median overall survival of patients with advanced     non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best     supportive care (BSC).   "
145362|NCT01380756|"     This study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The     dose escalation part of the study is aimed at evaluating the safety, tolerability and PK     (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects     may be enrolled in dose escalation. The dose expansion part of the study will consist of 20     subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from     the dose escalation part of the study.   "
145363|NCT01380743|"     This study will look at Drug-Drug Interactions Between AT2220 (duvoglustat hydrochloride) and     alglucosidase alfa (ERT) in Patients with Pompe Disease.   "
145364|NCT01380730|"     To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered     every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from     baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.   "
145365|NCT01380717|"     Patients with reduced kidney function have a higher risk of heart disease and death. Studies     have shown that blood vessels in patients with hypertension change with a decrease of lumen     size and growth of the vessel wall. By treating patients with antihypertensive certain     medication vessel lumen and walls normalize. Treating hypertension in patients with chronic     kidney disease slows the progression of kidney function loss.      The aim is to compare different degrees of antihypertensive medication in patients with     chronic kidney disease and hypertension will slow the progression of kidney loss.   "
145366|NCT01380704|"     This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically     healthy subjects with mild to moderate depressive symptoms who are not taking any     antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of     this study.   "
145367|NCT01381783|"     The purpose of this study is to determine if topical anesthesia is safe for     phacoemulsification in eyes with comorbidities.   "
145368|NCT01381770|"     The purpose of this study is to demonstrate that platelet-derived repairing factors are     effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label,     single arm, single centre has been designed. Sample size will be 25.   "
145769|NCT01376362|"     The objective of this study is to investigate the safety and efficacy of ocular instillations     of interferon gamma-1b as a potential treatment for cystoid macular edema (CME) secondary to     uveitis.   "
145369|NCT01381757|"     Background:      -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed     with a test that is fast and inexpensive but not always accurate. The purpose of this study     is to test a new method for diagnosing TB, called the microscopic-observation     drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also     gives information on which drugs will work best in each case.      Objective:      -To test a new method for diagnosing tuberculosis called the microscopic observation drug     susceptibility test.      Eligibility:        -  Participants must be 12 years of age or older.        -  They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an          x-ray indicating that TB is present.      Design:        -  Participants will take part in the study from 6 months to 21 months and be assigned to          one of three groups, depending on what type of TB they have.        -  At the first visit, researchers ask questions about general health and symptoms of TB.          They check vital signs, draw blood, and ask for a sputum sample. The blood is used to          check for HIV infection and for the number of CD4 cells, which measures the severity of          the HIV infection.        -  The 2-, 5-, and 6-month visits are similar to the first. Those who do not have          multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR          TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants with          MDR TB will remain in the study for 21 months.        -  No treatment is provided as part of this study.   "
145370|NCT01381744|"     Plague is an infectious disease of animals and humans caused by bacteria, Yersinia pestis.     Modern antibiotics are effective against plague, but if an infected person is not treated     promptly the disease is likely to cause illness or death. The purpose of this study is to     evaluate at the safety, immunogenicity (bodily defense reaction), and tolerability of a new     research vaccine. Up to 48 people will be enrolled in this study at the Center for Vaccine     Development at Saint Louis University. Four groups of 12 volunteers will be given vaccine or     placebo (inactive substance) one group at a time starting with the lowest dose working up to     the highest dose. Shots will be given in the arm 2 times separated by 28 days. Study     procedures include: physical exam, blood samples, and recording temperature and side effects     in a memory aid. Participants will be involved in study related procedures for about 13     months.   "
145371|NCT01381731|"     The objectives of this trial are to:        -  Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus          placebo following one week of treatment in subjects undergoing photorefractive          keratectomy (PRK).        -  Evaluate the potential of diquafosol to accelerate corneal wound          healing/re-epithelialization following PRK.   "
145372|NCT01381718|"     RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer     treatment.      PURPOSE: This phase II randomized trial studies how well modafinil works in treating children     with memory and attention problems caused by cancer treatment for a brain tumor.   "
145373|NCT01381705|"     RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer. It may also help doctors predict how well patients will respond     to treatment.      PURPOSE: This research study is studying biomarkers in predicting response to rituximab     treatment in samples from patients with indolent follicular lymphoma.   "
145408|NCT01381250|"     A trial testing the outcome of an Internet-based treatment of pathological gambling with the     hypothesis that there will be improvements both immediately and up to 36 months. It is also     hypnotized that treatment response can be predicted from background variables.   "
145374|NCT01381692|"     This randomized phase I/II trial studies the side effects and the best dose of temsirolimus     when given together with bortezomib, rituximab, and dexamethasone and to see how well they     work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with     untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or     follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of     cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab,     can block cancer growth in difference ways. Some block the ability of cancer cells to grow     and spread. Others find cancer cells and help kill them or carry cancer-killing substances to     them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the     growth of cancer cells, either by killing the cells or by stopping them from dividing. It is     not yet known whether bortezomib, rituximab, and dexamethasone are more effective with     temsirolimus in treating non-Hodgkin lymphoma.   "
145375|NCT01381679|"     This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol     Screening and Treatment project (ACT I), which assessed the cholesterol status, including     achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in     participants with coronary heart disease (CHD) already being treated with a statin. In this     study, participants without adequate LDL-cholesterol reduction with a statin underwent     extension of therapy with ezetimibe with the goal of achieving target levels.   "
145376|NCT01381666|"     The objective of the present work is to explore and compare the diagnostic quality of sputum     specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316     in patients diagnosed with interstitial lung diseases.   "
145377|NCT01381653|"     An existing face-to-face HIV prevention intervention (The Young Men's Health Project, YMHP;     R01DA20366) will be iteratively adapted and pilot-tested to target difficult to engage     high-risk young men who have sex with men (YMSM) via online social networking and aims to     reduce both high-risk sexual behavior and drug use.   "
145378|NCT01381640|"     This is a single dose pharmacoscintigraphic study investigating the differences in     paracetamol absorption between two formulations.   "
145419|NCT01381107|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose     study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with     buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are     inadequately/partially responding to current treatment with a stable dose of a     serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor     (SNRI).   "
145420|NCT01381094|"     The purpose of this study is to evaluate the dose response (efficacy), safety, and     tolerability of orally administered AKB-6548 in pre-dialysis subjects with anemia with repeat     dosing for 42 days.   "
145379|NCT01381627|"     Lung cancer is the second most commonly diagnosed primary neoplasia in Canada accounting for     22 865 new cases in 2007. Recent randomized trials have shown a significantly better     diagnostic yield and fewer unnecessary thoracotomies with endobronchial ultrasound-guided     transbronchial needle aspiration (EBUS-TBNA) when compared to conventional TBNA for various     clinical conditions including peripheral pulmonary lesions and sarcoidosis. EBUS-TBNA are now     routinely performed in our institution for staging of pulmonary and mediastinal cancer.     EBUS-TBNA are performed under monitored anesthesia care (MAC) in the endoscopy suite at the     Centre de soins ambulatoires of the Hôpital Maisonneuve-Rosemont.      Remifentanil, used in combined regime or as single agent proved to be effective and safe for     MAC. Nonetheless, anesthesiologists are still confronted to the respiratory depression     profile of remifentanil and other commonly used agents. An analysis of the ASA Closed Claims     demonstrated that respiratory depression remains a significant drawback during MAC in remote     locations. Furthermore, patients with coexisting pulmonary diseases scheduled for EBUS-TBNA     are at increased risk of such complications.      The investigators hypothesize that compared to the use of remifentanil-based MAC protocol,     the use of dexmedetomidine-based MAC protocol for EBUS-TBNA will result in a lower incidence     of major respiratory and hemodynamic adverse events (bradypnea, apnea, oxygen desaturation,     hypotension, hypertension, bradycardia and tachycardia) with equivalent overall procedure     conditions.   "
145380|NCT01381614|"     Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom     burden is limited in commercially insured patients (age >= 18 years and < 65 years).     Additionally, limited information exists on economic burden of adverse events associated with     treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is     to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic     RCC in a US real-world setting. Another objective is to quantify the economic burden of     severe adverse events with agents used in management of first line advanced/metastatic RCC     (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective     cohort design. Analyses of health insurance claims data from a large commercially insured     population will be employed in the current study. Study subjects will consist of all persons,     aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009;     these persons will be identified based in part on case-ascertainment algorithms. Analyses     will be directed at estimating annual rates of incidence and prevalence of     advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events     associated with treatments used in management of advanced/metastatic RCC (sunitinib,     sorafenib, bevacizumab, and pazopanib).   "
145381|NCT01381601|"     Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom     burden is limited in commercially insured adult patients. Additionally, limited information     exists on economic burden of adverse events associated with treatments for     advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate     the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US     real-world setting. Another objective is to quantify the economic burden of severe adverse     events with agents used in management of first line advanced/metastatic RCC (sunitinib,     sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design.     Analyses of health insurance claims data from a large commercially insured population will be     employed in the current study. Study subjects will consist of all persons, aged ≥18 years,     with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons     will be identified based in part on case-ascertainment algorithms. Analyses will be directed     at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as     symptom burden and costs of common severe adverse events associated with treatments used in     management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).   "
145382|NCT01381588|"     This is an observational study to investigate the prevalence of osteoporotic fractures in     post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including     GHs(general hospitals) and clinics will be enrolled.   "
145384|NCT01381562|"     This study is being conducted to evaluate the safety, efficacy and     pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal     infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use     in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity     that includes pathogens responsible for cIAI.   "
145385|NCT01381549|"     This study is being conducted to evaluate the safety, efficacy (clinical and     microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it     would be a suitable antibiotic for the treatment for febrile lower cUTI and     pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to     imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections.     GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for     cUTI.   "
145386|NCT01381536|"     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and     pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus     (SLE).   "
145387|NCT01381523|"     The goal of this study is to measure medical resource utilization, treatment patterns, and     costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of     sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who     are switched from one triptan to either SumaRT/Nap or a different single-entity triptan. The     analysis will compare the mean number of prescription tablets used (including triptans,     NSAIDs, opioids, and ergots) and migraine-specific medical resource utilization/costs and     pharmacy costs incurred by health plan members who switched to SumaRT/Nap from a     single-entity triptan. The null hypothesis for the triptan-naïve analysis is that no     difference will be observed between resource utilization and costs incurred by patients     treated with SumaRT/Nap and those treated with a single-entity triptan. The test hypothesis     is that one group will incur significantly fewer costs and/or significantly lower health care     utilization. For the triptan switch analysis, the null hypothesis is that no difference will     be observed in the costs or health care utilization between triptan patients who are switched     to SumaRT/Nap compared with those switched to a new triptan. The test hypothesis is that one     treatment group will experience significantly lower costs and/or lower health care     utilization.      The source of data for this analysis is the Lifelink Health Plan Claims Database (owned by     IMS Health, Inc). This claims database includes more than 60 million covered lives. In     addition to inpatient and outpatient records, this database includes standard and mail-order     pharmacy claims with paid and charged amounts and dates of service.      Data from July 1, 2008 to December 31, 2009 (study period) will be used to conduct these     retrospective analyses. Patients with at least one pharmacy claim for SumaRT/Nap between     January 1, 2009 and June 30, 2009 (enrollment period) will be identified. The date of the     first SumaRT/Nap pharmacy claim will be the index date for those patients. Each patient will     be propensity score matched with an oral triptan patient based on the following pre-index     covariates: age; gender; payer; geographic region; average monthly number of tablets of     triptans, NSAIDs, and opioids; and average number of hospitalizations, emergency department     visits, and physician visits in the month immediately preceding the index date as well as the     mean number of hospitalizations, emergency department visits, and physician visits in the     5-month pre-index period. SumaRT/Nap patients and their single-entity matched controls who     had no pharmacy claims for triptans prior to the index date will be analyzed in the triptan     naïve group, and the SumaRT/Nap patients and their single-entity matched controls who     switched to a new triptan will be analyzed in the switch analysis.   "
145388|NCT01381510|"     Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be     associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health     care costs.      The objective of this retrospective database analysis is to quantify the relationship between     adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention     (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic     hyperplasia (BPH). The study will also measure the economic impact associated with these     medical encounters.      The MarketScan database contains data from people with commercial health insurance and     Medicare and includes both medical and pharmacy data that are sourced directly from health     plans and employers. Approximately 18 million covered lives will be utilized for this study     in the time period from January 1, 2003 to September 30, 2009.      This study is a retrospective cohort analysis of medical claims data.   "
145389|NCT01381497|"     Migraine headaches lead to absenteeism and can restrict on-the-job productivity     (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce     migraine-associated productivity losses and return migraineurs to normal functioning within a     few hours of treatment.      This study is an observational, multicenter, parallel-group study of employed patients who     have been prescribed either a combination product containing sumatriptan and naproxen sodium     (SumaRT/Nap) or oral triptan monotherapy to treat acute migraine attacks. The study will     report results from 4 migraine attacks per patient. Eligible migraine attacks will be defined     as those preceded by a 24-hour, headache-free period with onset between 2 hours prior to the     start of and 4 hours before the end of a scheduled work shift. Data will be collected at time     of treatment and hourly until the end of the attack or the end of the workday. To estimate     baseline productivity, data will be collected from 50 randomly selected subjects during a     migraine-free workday.      The primary objective of this study is to compare migraine-related, work productivity losses     (absenteeism and presenteeism) reported by patients treated with SumaRT/Nap to losses     reported by patients treated with triptan monotherapy. The null hypothesis is that no     difference will be observed between the number of hours of productivity lost for patients who     treat workday migraine attacks with SumaRT/Nap and patients who treat migraine attacks with     an oral triptan alone. The alternative hypotheses are that patients in either treatment group     experience significantly fewer hours of lost productivity associated with migraine compared     to patients in the other treatment group.      The secondary objectives of this study are to measure the time between treatment and return     to patient-reported, normal functioning; to evaluate rescue medication use after initial     treatment; to measure total productivity loss following treatment at hourly time points; and     to estimate the probability of absenteeism when a migraine begins before or during the     workday. The null hypotheses for the secondary endpoints are that no differences will be     observed between the results reported by patients treating with SumaRT/Nap and patients     treating with triptan monotherapy. The alternative hypotheses are that either treatment is     superior to the other for each endpoint.   "
145390|NCT01381484|"     The purpose of this study is to determine whether La Jolie gel is effective in the treatment     of periorbital wrinkles.   "
145391|NCT01381471|"     The specific aim of this study is to describe 1 year Advair dispensing rates for patients     with COPD, and to measure the association between Advair adherence and healthcare utilization     (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD     exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat     are adherent versus those that are not.   "
145392|NCT01381458|"     This retrospective database study will assess differences in the risk of re-hospitalization     and other COPD-related exacerbations and costs for patients receiving fluticasone     propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i.e.     tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred     to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the     treatment of COPD.      This is a hypotheses testing study. Associations are compared between FSC and AC cohorts.      Hypotheses for the primary outcome and key secondary outcomes are presented below:      Specifically the study hypotheses for the primary outcome being tested were:      Ho: There is no difference in risk of COPD-related hospitalization between FSC and AC Ha:     There is a difference in risk of COPD-related hospitalization between FSC and AC      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:      Ho: There is no difference in COPD-related costs between FSC and AC Ha: There is a difference     in COPD-related costs between FSC and AC   "
145393|NCT01381445|"     This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to     explore the potential for skin thinning in healthy adult volunteers after 42±2 days of     treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086     2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or     clobetasol propionate 0.05% cream.   "
145394|NCT01381432|"     This post-marketing surveillance study is to investigate the efficacy and safety of     azathioprine tablets in subjects whom lung transplantation is performed.   "
145395|NCT01381419|"     This study described in the present protocol consists of two sections. Part A is the first     administration into man to evaluate the safety, tolerability and pharmacokinetics of single     ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled     design in healthy male and female (of non-childbearing potential) subjects. Part B will be an     open-label design in healthy male subjects to assess the GSK1144814 neurokinin-1 (NK1)     receptor occupancy by positron emission tomography (PET) scanning with [11C]-GR205171   "
145396|NCT01381406|"     This was a retrospective cohort design using administrative claims data from Jan 1, 2003     through Sep 30, 2007, representing the years of available data, were used for this study.     Managed care enrollees having at least one pharmacy claim for tiotropium (TIO) during the     study period were identified as the target population. An index TIO prescription was defined     as the first chronologically occurring pharmacy claim for TIO during the period Jan 1, 2004     to Aug 31, 2006, called the enrollment period. The date of the index TIO prescription was     termed as the index Rx date, and the 1-year period before the index Rx date was termed as the     pre-index period. The period after the index date was termed as the post-index date, and is     further divided into a 30-day combination assessment period and a 1-year follow-up period.     COPD clinical and economic outcomes were measured in a variable length follow up period.      The combination assessment period, defined as the 30-day period following the index Rx date,     was used to categorize patients into 2 cohorts: TIO alone or TIO + FSC (fluticasone     propionate/salmeterol xinofoate combination) depending on whether they use FSC in combination     with TIO during this period. Combination therapy with TIO + FSC was defined as having an FSC     claim on the same date as the TIO claim or a TIO and FSC pharmacy claim with overlapping days     supply occurring within 30 days of index Rx date. Enrollees adding FSC for the first time     after the 30-day combination assessment period were excluded from the sample, thus ensuring     that the TIO-alone cohort is not using FSC. No outcomes were assessed in the 30-day     combination assessment period. The 1-year period after the end of the 30-day combination     assessment period was termed as the follow-up period and was used to assess all study     outcomes. Enrollees were required to be continuously eligible in their health plans during     the pre-index and post-index periods for a total of 25 months. An intent-to-treat approach     was used for the analyses. Thus, patients identified to be in a drug therapy cohort were     considered to be using that therapy during the entire follow-up period, regardless of therapy     discontinuations.      Specifically the study hypothesis for the primary outcome being tested was:      Ho: There is no difference in risk of any COPD-related exacerbation between TIO+FSC and TIO     cohorts Ha: There is a difference in risk of any COPD-related exacerbation between TIO+FSC     and TIO cohorts      Hypothesis for the key secondary outcome of COPD-related costs that was tested was:      Ho: There is no difference in COPD-related costs between TIO+FSC and TIO cohorts Ha: There is     a difference in COPD-related costs between TIO+FSC and TIO cohorts   "
145397|NCT01381393|"     This is an open label, multi-centre, non-interventional post-marketing surveillance.   "
145398|NCT01381380|"     This study is a pain intensity evaluation in patients with myofascial pain submitted     kinesitherapy after trigger point injection.   "
145433|NCT01380925|"     The research team is studying why some African American families have multiple cases of     breast cancer.      This study will help to better understand if there are undiscovered genes unique to African     Americans that may predict early breast cancer risk.      Breast cancer survivors AND their relatives who are also breast cancer survivors are being     recruited to the study.   "
145399|NCT01381367|"     Streptococcus pneumoniae is the most common causes of community-acquired pneumonia and     exacerbations in chronic obstructive pulmonary disease (COPD) patients, which are associated     with morbidity, mortality, and higher health-care cost. In addition, recently high daily dose     of inhaled corticosteroid (ICS) therapy became more evident to be beneficial in     moderate-to-severe COPD patients, but excess risk of pneumonia shown in database analysis was     worried about by primary physicians. The use of pneumococcal polysaccharide vaccination     (PPSV23) has protective efficacy to eliminate infection of Streptococcus pneumoniae from     previous studies. If the use of PPSV23 can reduce the incidence of pneumonia or exacerbations     in COPD patients using high daily dose of ICS, the benefit of ICS can be preserved and risk     of pneumonia can be reduced. However, there is only limited data supporting this hypothesis.     In this study, the investigators will conduct a double-blinded, randomized controlled trial     to evaluate the clinical efficacy of PPSV23 in severe COPD patients using high daily dose of     ICS.   "
145400|NCT01381354|"     The study will use a multimodal therapeutic lifestyle intervention consisting of a study     diet, stressing more vegetables and fruit, elimination of foods at greatest risk for food     allergy, meditation, self massage, progressive exercise and neuromuscular electrical     stimulation for rehabilitation of gait and fatigue disability in the setting of secondary and     primary progressive multiple sclerosis with gait disability.   "
145401|NCT01381341|"     A pharmacokinetic study to compare 2 clinical formulations of linifanib.   "
145402|NCT01381328|"     The purpose of this study is to correlate the different patterns of resistance mutations     observed in vivo in patients failing RAL treatment with the fold-change resistance determined     by the phenotypic assay.   "
145403|NCT01381315|"     It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic     drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk     for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node     dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of     the breast during the procedure would potentially decrease the incidence of arm lymphatic     disruption and subsequent development of lymphedema while providing adequate axillary breast     nodes needed for staging.   "
145404|NCT01381302|"     The study population will include 100 parkinsonian patients in early stage of disease, with     total duration not exeeding 5 years.      The patients will undergo neurologic examination and evaluation of disease severity using the     unified PD rating scale. Subsequently a brain SPECT will be performed using Tc-99m-Trodat1.   "
145405|NCT01381289|"     The purpose of this expanded access program is to provide VX-770 prior to its commercial     availability to people with cystic fibrosis (CF) who have at least one copy of the G551D-CFTR     mutation and who are in critical medical need and who are not eligible for participation in     other Vertex-sponsored studies.   "
145406|NCT01381276|"     The purpose of this study is to determine the vitamin A equivalents in high-carotenoid     varieties of cassava.   "
145407|NCT01381263|"     Recurrent pain, such as headache, stomach pain and musculoskeletal pain is common in children     and adolescents. Children and adolescents are reported to have restrictions in daily life     activities, social contacts, and school attendance, and to have poorer academic skills and as     well as an increased utilization of heath care services due to pain problems. The treatment     approaches available today for teenagers with pain are often biological/physiological and     little evidence for their effectiveness has been shown. It is urgent to try new interventions     for pain problems in early ages in order to prevent disability, development of maladaptive     coping strategies and to avoid negative impact on daily activities.      The optimal treatment regime for paediatric pain patients has been suggested to be cognitive     behavioural approach integrated with physical therapy The aim of this project is to develop     and evaluate in a randomized controlled trial a treatment program with a behavioural medicine     approach (suitable to use in primary care or school based health care context) compared with     standard treatment for adolescents with persistent pain problems. The aim is also to compare     short and long-term costs for patients and for the health care system related to the two     interventions, in order to determine strategies for future cost-effective care of children     and adolescents experiencing recurrent pain.   "
147791|NCT01349777|"     This study is an open label, multi-center, randomized trial, which is designed to evaluate     the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in     patients undergoing PCI compared to conventional clopidogrel (Plavix®).   "
145409|NCT01381237|"     Due to the many problems associated with reduced balance and mobility, providing an effective     and engaging rehabilitation regimen is essential to progress recovery from impairments and to     help prevent further degradation of motor skills. The purpose was to examine effects of     physical therapy based on the task-oriented approach delivered in an engaging, interactive     video game paradigm. The intervention focused on performing targeted dynamic tasks, which     included reactive balance controls and environmental interaction. Thirty community dwelling     and ambulatory older adults attending the Day hospital for balance and mobility limitation     treatment participated in this study. Participants were randomly assigned to either a control     group or experimental group. The control group received the typical rehabilitation program     provided at the Day Hospital, consisting of strengthening and balance exercises. The     experimental group received a program of dynamic balance exercises coupled to video game     play, using a centre of pressure (COP) position signal as the computer mouse. The tasks were     performed while standing on a fixed floor surface with progression to a compliant sponge pad.     Each group received 16 sessions, scheduled two per week, each lasting 45 minutes. Balance     performance measures and spatial-temporal gait variables were obtained pre- and     post-treatment Findings demonstrated significant improvements for both groups in balance     performance scores post-treatment, and change scores were significantly greater in the     experimental compared to control group. No significant treatment effect was observed in     either group for the spatial-temporal gait variables. In conclusion dynamic balance exercises     on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based     exercise. This in turn resulted in a greater improvement in dynamic standing balance control     compared to the typical exercise program. However there was no transfer of effect to gait     function.      Key Words: Balance, Postural; Rehabilitation; Therapy, computer-assisted; Video Games; Center     of Pressure.   "
145410|NCT01381224|"     The purpose of this project is to determine the effect of lower back injections on select     biomechanical outcomes, walking patterns, lower back flexibility and balance.   "
145421|NCT01381081|"     The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in     degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing     effect on knee cartilage degenerative injuries are not conclusive to establish a standard of     behavior, although PRP has shown to improve joint functionality and reduce pain.      Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to     a more effective and lasting functional recovering than corticosteroid intra-articular     injections.   "
145411|NCT01381211|"     Hepatocellular carcinoma (HCC) is a primary malignant tumor of the liver that accounts for an     important health problem worldwide. In only 10% - 15% of all patients with HCC, tumors are     considered resectable at presentation. In contrast to metastatic liver disease, there is no     role for systemic chemotherapy in the treatment of HCC. Today only evidence is available for     Sorafenib, a tyrosine kinase inhibiting agent. The arsenal of non-surgical therapies can     roughly be divided into local ablative, transarterial and systemic therapies. In well     selected patients, local ablative therapy can offer favorable long term results.      For patients with disease confined to the liver, but locally more advanced, transarterial     treatment modalities are proposed. These therapies exploit the dual blood supply to the     liver. HCC derives its blood supply almost entirely from the hepatic artery, while liver     parenchyma derives > 75% of its blood supply from the portal vein. Antitumoral agents, such     as cytotoxic drugs or radionuclides, can be delivered in close proximity of the tumor.      Examples of transarterial therapies are: transarterial chemoembolization (TACE), bland     transarterial embolization (TAE), transarterial chemoembolization with drug eluting beads     (TACE-DEB) and transarterial radioembolization with Iodine-131 or Yttrium-90.      TACE is currently the gold standard for treatment of patients with intermediate stage HCC,     with a reported median survival of around 17 months. A novel development in the TACE     treatment for HCC is the drug-eluting bead (DEB). Recently performed small clinical trials     reported the efficacy of DEBs in the treatment of intermediate stage HCC, which is     substantially higher compared to conventional TACE.      Yttrium-90 radioembolization (90Y-RE) is a relatively recently developed technique which     implements transarterial administration of minimally embolic microspheres loaded with     Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.      In this study the investigators want to prospectively compare TACE-DEB and 90Y-RE, two novel     treatments that both have theoretical and/or proven advantages compared to the use of     conventional TACE, in patients with intermediate stage HCC.   "
145412|NCT01381198|"     The purpose of this study is to evaluate the effects of an additional distal rectus femoris     transfer carried out as a part of single-event multilevel surgery in children with spastic     diplegic cerebral palsy.   "
145413|NCT01381185|"     The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet     therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of     acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA)     will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin,     clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of     clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles) will     be performed.   "
145414|NCT01381172|"     The objective of this investigation is to evaluate the safety and effectiveness of the     OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.   "
145415|NCT01381159|"     The high burden of asthma appears to be related to poor asthma control, which is associated     with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and     worse pulmonary function. Despite the availability of effective treatments, more than 58% of     asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is     considered by experts to be one of the most important behavioural factors linked to achieving     optimal asthma control. However, there is a paucity of research on interventions specifically     designed to improve ICS adherence among adult asthmatics. The vast majority of intervention     studies to date used atheoretical interventions to target behaviour change, relying mainly     upon educational approaches which have been criticised for failing to translate knowledge     into action. This may be due to the fact that most education-based approaches do not     specifically address or help patients overcome ambivalence about behaviour change, which is     necessary for ensuring daily adherence. Motivational communication (MC) is a client-centred     intervention that focuses on enhancing intrinsic motivation to change a particular behaviour,     and exploring and resolving ambivalence about behaviour change. Brief MC sessions (e.g., 1-5     x 15-30 minute sessions) have been shown to improve a variety of health behaviours (e.g.,     reduce alcohol consumption, improve dietary habits, increase exercise behaviour, and improve     medication adherence) and health outcomes (reduce blood pressure, body mass index, and     cholesterol levels). However, no studies to date have assessed the efficacy of using MC to     improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MC to     improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent     asthmatics. It is hypothesized that patients randomized to the MC condition will exhibit     significantly improved ICS adherence at 6 and 12-months post-intervention, independent of     baseline levels and covariates, relative to patients randomized to the usual care control     condition.   "
145416|NCT01381146|"     The purpose of this study is to evaluate feasibility of modularized delivery of the Impact of     Crime (IOC) group intervention with jail inmates, and obtain preliminary data on its     effectiveness in reducing post-release recidivism, substance abuse, and HIV risk behavior.   "
145417|NCT01381133|"     The purpose of this study was to evaluate the effectiveness and cost-effectiveness of two     types of outpatient treatment with and without Assertive Continuing Care (ACC) for 320     adolescents with substance use disorders. Study participants were randomly assigned to one of     four conditions: (a) Chestnut's Bloomington Outpatient Treatment (CBOP) without ACC; (b) CBOP     with ACC; (c) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session model     (MET/CBT7) without ACC; and (d) MET/CBT7 with ACC. Based on prior quasi and experimental     studies, the investigators hypothesized that MET/CBT would be more effective and     cost-effective than CBOP in terms of increasing days abstinent and decreasing substance abuse     problems. Additionally, the investigators hypothesized that the groups receiving ACC would     have significantly better outcomes than the groups without ACC. Lastly, the investigators     hypothesized that adding ACC to MET/CBT would be the most cost-effective option in terms of     days abstinent.   "
145444|NCT01380652|"     The aim of this study is to investigate the change of physical activity in COPD-patients     performing a whole body vibration training additional to a standard three-week rehabilitation     program in comparison to patients performing merely a standard rehabilitation program.   "
145445|NCT01380639|"     The aim of this study is to investigate the exercise capacity in COPD-patients performing a     vibration training additional to a standard three-week rehabilitation program in comparison     to patients performing merely a rehabilitation program.   "
145418|NCT01381120|"     Most ureteral stent insertions follow ureteroscopy procedures for stone management. Stents     are essentially designed to prevent the blockage of the ureter. Such blockage is often a     result of inflammation caused by ureteroscopy procedures. The stent provides a secure     passageway for urine as it travels from the kidneys to the bladder, circumventing potential     urinary retention. In our community, only one kind of stent is used, and it is manufactured     by Bard. Standard protocol involves the removal of the stent 5 to 8 days following insertion.     If stenting is required for greater than 8 days, special accommodations will be made for you     in this study.      Unfortunately, pain and lower urinary tract symptoms are often associated with the insertion     and removal of stents. It is our goal to determine whether VESIcare is capable of relieving     such symptoms.      As a prospective member of this study, you will be asked to complete three surveys. The first     survey will ask you about your experiences of urinary urgency and pain before your surgery.     If you are an emergency patient, you will be asked to remember your condition before the     surgery, completing this questionnaire at your first post-op visit. If you are not an     emergency patient, this survey will be completed before your surgery. If your stent is     removed within 5 to 8 days of surgery, you will be asked to complete the second survey at the     time of removal. You will then complete the final survey at a scheduled post-operative     check-up 4 to 5 weeks later. If your stent remains inserted for greater than 8 days after     surgery, you will be asked to complete the second survey 3 to 4 days after your stent was     inserted. You will then complete the final survey, 7 to 8 weeks post-op.      Throughout this study, both VESIcare and non-VESIcare patients will be important in     determining whether VESIcare truly is capable of relieving stent pain. As such, you will be     randomly assigned to one of the two groups, those receiving VESIcare, and those who are not.   "
145434|NCT01380912|"     A randomised double-blinded study, in which the patients either get methylprednisoloneacetate     or saline solution in the mastectomy cavity to evaluate the efficacy of     methylprednisoloneacetate in preventing seroma in patients operated for primary breast     cancer.   "
145424|NCT01381042|"     Previous studies have shown active brown adipose tissue (BAT) is present in adults and may     play important roles in regulating energy homeostasis. However, the majorities of these     studies were done in patients undergoing scanning for cancer surveillance, and may not     reflect BAT behavior in healthy individuals. In addition, little is known about the ethnic     variation in BAT activity, particularly in Chinese adults. Due to the large amount in our     cohort, we are able to look at the difference between subjects for cancer surveillance (CS)     and subjects for medical check-up (MC), and to clarify the impact of clinical and lifestyle     parameters.   "
145425|NCT01381029|"     Investigators in the Division of Infectious Diseases are carrying out a study to determine if     human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza     vaccination develop an adequate antibody response. The study group will consist of     individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the     Seasonal Influenza vaccine.   "
145426|NCT01381016|"     The sole purpose of this study is to evaluate pathophysiology of disease. The disease state     that is being evaluated is the obesity-related alterations in reproductive hormones        -  The obesity epidemic in the United States is advancing at an accelerated pace. It is          estimated that by 2015, 41% of U.S. adults will be obese as defined by a body mass index          (BMI) of greater than 30 kg/m2. The U.S. government's 2010 Dietary Guidelines regard          obesity as the single greatest health hazard in this century. Female adult obesity is          associated with menstrual cycle irregularities, ovulatory dysfunction and a higher risk          of obstetrical complications. This reproductive phenotype of obesity is worsened by          further increases in BMI and is not solely due to anovulatory infertility. While the          association of adiposity with subfertility is well documented in population studies, the          underlying mechanisms remain poorly understood. The main objective of this proposal is          to clarify the nature of the obesity-related reproductive endocrine abnormalities and          identify potential etiologies amenable to therapy.        -  Hypothesis: The hypothalamic-pituitary axis is abnormally sensitive to estradiol          negative feedback in obesity.   "
145427|NCT01381003|"     Chronic Granulomatous Disease (CGD) is a rare inherited disorder in which patients suffer     from severe infection and inflammation. The first indication of disease usually appears in     early childhood. The basic defect found to be lie in specialised white blood cells called     phagocytic cells, which are responsible for engulfing and destroying germs. In CGD, there is     a defect in an enzyme (known as NADPH-oxidase) that is responsible for generating bleach like     substances that are important for killing some important germs. In the form of the disease     known as X-CGD (which accounts for two thirds of patients), there are defined mistakes in a     gene called gp91-phox, which is a key part of the NADPH-oxidase.      In many cases, patients can be protected from infection by constant intake of antibiotics.     However, in others potential life-threatening infections break through. In some cases     patients also develop serious inflammation requiring high doses of drugs such as steroids.     CGD can be cured by bone marrow transplant, but the best results are available when there is     matched donor available. Transplant from unmatched donor have a much worse outcome.      Gene therapy of CGD can be performed by introducing a normal copy of human gp91-phox gene     into the blood forming stem cells of patients' bone marrow by using a gene carrier (in this     study called lentiviral vector). After treatment of the bone marrow cells in a specialised     laboratory are given back to the patient and will grow into functional phagocytic cells.   "
145815|NCT01375764|"     The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG     145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein     cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective     dose of a statin.   "
145428|NCT01380990|"     Adenosine Deaminase (ADA) is an enzyme, needed by body to develop lymphocytes of the immune     system. Children who are born in mutations with mutations in ADA gene have severe combined     immunodeficiency (SCID). Children with ADA-deficient SCID generally die in the first year of     life from severe infections because they do not have immune system that can fight against     infections. ADA deficient individuals can be cured by bone marrow transplant, but the best     results are obtained when there is fully matched family donor is available. In the absence of     a matched related donor, transplants from unrelated or mismatched donors have a much worse     outcome. There is a form of enzyme therapy (PEG-ADA) for ADA-deficient SCID, in which     children receive injections of purified ADA enzyme 1-2 times each week. These injections can     allow the immune system to recover to a level that protects children from infections.      However, these injections have to be given weekly and are very expensive (£ 125,000 - 200,000     annually) and the recovery of the immune system is not sustained over time.      Gene therapy for ADA-deficient SCID could be performed by introducing a normal copy of the     human ADA gene into the blood forming stem cells of the patient's bone marrow by using a new     type of gene delivery system (in this trial called a lentiviral vector). The gene corrected     cells are then transplanted back into the patient after small dose of chemotherapy. These     gene corrected stem cells can survive into the body and make lymphocytes. In this trial, we     will determine whether gene therapy for ADA-deficient SCID using lentiviral vector is safe,     feasible and effective   "
145429|NCT01380977|"     This pilot study is designed to evaluate the efficacy of the Impact of Crime (IOC) group     intervention for jail inmates. The hypothesis is that participants in IOC will show decreases     in criminogenic thinking, decreases in shame, increases in guilt, and increases in empathy,     which in turn will be reflected in reduced recidivism (official records and self report),     relative to those randomly assigned to a treatment as usual group.   "
145430|NCT01380964|"     The purpose of this study is to identify potential biomarkers for the diagnosis, disease     progression assessment and response to treatment in patients with Duchenne Muscular     Dystrophy.   "
145431|NCT01380951|"     Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory     and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is     considered to be appropriate for the antiviral treatment on CHB patients with liver     cirrhosis.   "
145432|NCT01380938|"     WRITE study aim at identifying the effectiveness of an innovative individualized schedule of     treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.   "
145435|NCT01380899|"     Parkinson's disease (PD) is a degenerative disease that can be difficult to diagnose. The     clinicopathological studies had demonstrated a 76% accuracy in the clinical diagnosis of PD.      At the beginning of PD is difficult for the clinician to distinguish from Parkinsonism Plus     Syndromes (PPS) due to the similarity of symptoms and the lack of specific diagnostic tests.      Specific biomarkers to help improve the accuracy of diagnosis and to separate these two     entities are highly needed      The histological hallmark for definite diagnosis of PD is the presence of fibrillar     aggregates of phosphorylated alpha-synuclein called Lewy bodies (LBs) and Lewy neurites.     Previous autopsy-based studies have revealed that alpha-synuclein is deposited in the     peripheral autonomic nervous system including the enteric nervous system of the alimentary     tract, cardiac plexus, adrenal medulla and skin.      For this reason, in patients with parkinsonism, an alternative tool could be to demonstrate     alpha-synuclein fibrillar aggregates in the skin, allowing early and appropriate diagnosis.   "
145436|NCT01380886|"     This is a randomized, multi-center, double blind, parallel study to compare growth and     tolerance of healthy term infants fed either control or experimental infant formula.   "
145437|NCT01380873|"     This trial is conducted to        1. assess whether SLM0807 alters pharmacodynamics of HKB0701        2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and          multiple co-administration of HKB0701/SLM0807 in healthy subject   "
145438|NCT01380860|"     The purpose of this study is to compare rates of hernia formation between colostomies created     with no hernia preventing mesh versus colostomies created with a particular mesh.   "
145439|NCT01380847|"     The investigators have shown that epithelial-to-mesenchymal transition (EMT) markers in early     protocol biopsies of the renal allograft predicts the progression of fibrosis during the     first year post-transplantation.      The investigators will develop a non-invasive approach for predicting fibrosis as a     substitute for the invasive allograft biopsy procedure, by longitudinal assessment of the     mRNA expression level of genes implicated in EMT/fibrogenesis and inflammation in urinary     cells from kidney transplant recipients during the first year post-transplantation.   "
145440|NCT01380834|"     The objective of this study is to assess the efficacy of paravertebral nerve blocks, single     shot, with ropivacaine 0.5% for postoperative pain control after elective laparoscopic     cholecystectomy as compared with incisional administration of same local anesthetic at     laparoscopic insufflation ports by the surgeon.   "
145441|NCT01380691|"     This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684     with Alcohol in Healthy Subjects. This study will run approximately for 34 days.   "
145442|NCT01380678|"     The purpose of this study is to evaluate that intralesional injection of bevacizumab on     primary pterygium can reduce the corneal pterygium area, inflammation, redness and other     symptoms.   "
145443|NCT01380665|"     The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when     applied to either the hip or knee area over a surgical cut for the time you are hospitalized.   "
145816|NCT01375751|"     The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous     evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in     adults with heterozygous familial hypercholesterolemia (HeFH).   "
145446|NCT01380626|"     Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and     Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation     in regard to improvement of 6-minute-walking distance. The aim of this study is to     investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency     patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with     strength and endurance training. In addition to conventional diagnostic procedures, muscle     biopsies from the M. vastus lateralis will be conducted before and after rehabilitation     program followed by biochemical, histochemical and immunohistochemical analysis of the     probes.   "
145447|NCT01380613|"     The goal of this study is to examine how social networks, neighborhood, and depression are     related to HIV risk. The intervention is designed to train individuals to cope with feelings     of depression or stress as a way to reduce their risk for HIV.   "
145448|NCT01380600|"     The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594     (Pexa-Vec) administered intravenously every 2 weeks in colorectal carcinoma patients who are     refractory to or intolerant of oxaliplatin, irinotecan, and Erbitux treatments.   "
145449|NCT01380587|"     The purpose of the study is to determine the utility of XCL1 in the prognosis of acute     lymphoblastic leukemia.   "
145450|NCT01380574|"     The purpose of this study is to investigate the complications of cardioversion of acute (<48     hours duration) atrial fibrillation (AF).      Primary Outcome Measures:      - Incidence and predictors of thromboembolic complications, especially stroke, and death <31     days after cardioversion of acute AF      Secondary Outcome Measures:        -  Number of therapy non-responder and early recurrence of AF        -  Bleeding complications during the 31 days follow-up        -  Hemodynamic complications of cardioversion      Estimated Enrollment: 3000 cases      Study Start Date: Jun 2011      Estimated Study Completion Date: December 2011   "
145451|NCT01380561|"     This is an open label, single center, metabolite identification, mass balance, and PK study     in healthy male volunteers.   "
145452|NCT01380548|"     This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in     subjects with iron deficiency anemia.   "
145453|NCT01380535|"     The purpose of this study is to evaluate the safety and effectiveness of extracorporeal     photopheresis therapy when added to standard drug therapies administered to patients with     moderate to severe chronic graft-versus-host disease.   "
145454|NCT01380522|"     The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.     Searle, Inc.   "
145455|NCT01380509|"     The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.     Searle, Inc.   "
145456|NCT01380496|"     The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen     doxycycline monohydrate 100 mg.   "
145457|NCT01380483|"     The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen     doxycycline monohydrate, 100 mg.   "
145460|NCT01380444|"     The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus     sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52     weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery     rates, fracture healing rates, fracture related adverse events, and health-related quality of     life, including the Parker mobility score and Harris Hip Score.   "
145461|NCT01380431|"     The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets     and IPR Pharmaceuticals, Inc. Zestril (R).   "
145462|NCT01380418|"     Some overweight individuals develop problems with their breathing such that they gradually     breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the     blood, called ventilatory failure. As a consequence, if such a person develops a chest     infection, they are more likely to become seriously ill and need intensive care. In addition     they are much more likely to develop severe complications during and following operations.     This problem can be treated with a machine at home used overnight to help breathing. It is     interesting that ventilatory failure only happens in some overweight individuals, and the     investigators do not understand what factors make this complication develop. There are a     number of theories: for example the distribution of the fat, additional lung disease (such as     asthma), the addition of obstructive sleep apnoea, a condition when there are periods of     cessation of breathing overnight (which is more common in obese individuals), weak muscles of     breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and other     hormonal changes.      The investigators intend to measure many potential factors in a range of overweight     individuals, some who have ventilatory failure, and some who do not, to try and work out     which are the important factors that cause this problem. If the investigators can identify     such factors, then this will help predict in advance who is at risk from chest infections and     during operations; thus allowing for earlier provision of an overnight breathing machine.     This should reduce complications and potentially deaths in such individuals.   "
145463|NCT01380405|"     Given the importance of the correct use of inhalers by patients with Chronic Obstructive     Pulmonary Disease (COPD) for the appropriate treatment of the disease, the self-care     programme which will be assessed will consist of an educational intervention on the correct     use of inhalers.      For this aim, we have designed this study to assess the influence of both individualized and     collective self care programmes about the correct use of inhalers improves the functional     state of patients with COPD compared to when there is no educational intervention.   "
145464|NCT01380392|"     The aims of this study are to (1) understand the uncertainty , personality and coping     strategies in patients with HCC, and identify the significant factors for coping.   "
145653|NCT01377909|"     Objective: The goal is to improve peginterferon sensitivity in previous poor responders.     Sensitivity here means the host's ability to kill more HCV.      Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin     monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.   "
145465|NCT01380379|"     Previous research has shown that self-defense training can lead to gains in women's     assertiveness, self-esteem, self-efficacy, and physical competence, and decreases in anxiety,     helplessness, fear, and avoidant behaviors. However, most of this research has been conducted     with healthy women who had not previously experienced physical or sexual violence. The     investigators believe that women with such trauma histories require additional care because     of potential triggering symptoms. As such, the investigators are mindful of the potential for     triggering trauma symptoms and will work with the women so that they feel safe and     comfortable in their participation. This pilot study aims to examine whether similar     psychological gains from self-defense training are made in women who have previous     experiences of physical and/or sexual violence.   "
145466|NCT01380366|"     Patients who are being asked to participate in this study have a short small bowel and will     be prescribed to take the medication: Zorbtive® (Zorbtive/Somatropin/(rHGH)). Zorbtive® is     an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if     taking this medication improves small bowel function by helping it to take in food,     nutrients, vitamins and minerals. The investigators also believe that if the small bowel is     absorbing food and nutrients better, liver function will improve as well. Therefore, liver     function will also be monitored during the course of the study by performing blood tests.   "
145467|NCT01380353|"     The purpose of this study is to look for ways to improve breast cancer treatment by giving     breast cancer drugs through the skin of the breast.      The drug used in this study is a diclofenac epolamine patch and is a nonsteroid     anti-inflammatory pain reliever. The drug amount that gathers in the breast, after     application of a patch to the skin of the breast, will be measured and compared to the amount     that is found in the breast when the patch is applied to the skin of the belly.   "
145468|NCT01380340|"     This study will investigate the effects of a new form of early intervention for senior     drivers who are at risk of changes to their driving status. The early intervention consists     of group activities involving planning and professionally facilitated discussion.      There are three main research hypotheses for this study. Firstly, it is hypothesised that     early intervention, in the form of the information and planning group, will not be associated     with either increases or decreases in driving assessment failure or driving cessation.     Secondly, it is hypothesised that early intervention will be associated with patterns of     reduced depression and less persistent negative mood states. Thirdly, it is hypothesised that     early intervention will be associated with patterns of sustained levels of important quality     of life indicators such as community participation and social relationships.   "
145469|NCT01380327|"     This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is     designed to study biomarkers of the immune response to allergen immunotherapy and the safety     of this therapy in a pediatric population.   "
145470|NCT01380314|"     Cutaneous leishmaniasis is endemic in the New World from approximately the US-Mexican border     through Central America and the Northern part of South America down to the level of Rio de     Janeiro.      Until recently, the standard treatment for the leishmaniases was pentavalent antimony     (Glucantime or Pentostam). The cure rate for L panamensis in Colombia is 91%-93% [Soto, 1993;     Velez, 1997], a large study with several formulations of antimony found a combined     Bolivia-Colombia cure rate of 86% [Soto, 2004b], and in work just completed, the cure rate in     Palos Blancos, Bolivia is 15 of 16 = 94% [ Soto, manuscript in preparation]. Nevertheless,     pentavalent antimonials have the disadvantages of multiple injections and mild-moderate     clinical toxicity [gastrointestinal complaints, liver enzyme elevations, pancreatic enzyme     elevations], all of which are particularly unpleasant for a moderate clinical problem such as     cutaneous leishmaniasis.      The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and     Bolivia. In Colombia, the cure rate for miltefosine was 91% [Soto 2004a] and in the     just-completed trial in Palos Blancos, the cure rate for miltefosine was 32 of 37 = 88 % .     Side effects seen in patients with cutaneous disease that can be specifically attributed to     the drug are nausea and vomiting of mild grade in approximately 25% of patients, and     low-grade elevation of creatinine also in approximately 25% of patients [Soto 2001; Soto     2004].      The 6-month cure rate did not reach 100%, and miltefosine was relatively slow to cure     compared to Sb. 31 of 44 evaluable miltefosine patients (70%) were cured by 1 month after     therapy, compared to 16 of 16 evaluable Glucantime patients (100%).      Imiquimod (Aldara; 3M Pharmaceuticals) is a novel immune response-activating compound,     approved by the FDA for cervical warts, that activates macrophage killing of Leishmania     species. Combined imiquimod plus Glucantime was used as rescue treatment in 12 patients with     Peruvian cutaneous leishmaniasis who had previously not responded to Glucantime alone. 90% of     patients were cured at the 6-month follow-up period [Arevalo, 2001]. In a follow up study     [Miranda-Verastegui et al, 2005], naïve patients were randomized between the combination of     Sb plus imiquimod (18 patients) vs Sb plus placebo (20 patients). The cure rate at 1 month     after therapy was 50% in the imiquimod +Sb group compared to 15% in the placebo+Sb group (p =     0.02). By 12 months after therapy, the Sb+placebo group had caught up, and the cure rate was     72%-75% in each group. Local side effects were evaluated. Edema, itching, burning, pain were     equal in the two groups. There was more erythema in the imiquimod grup (55% of patients)     compared to the placebo group (25% of patients).      The Imiquimod studies in neighboring Peru suggest that combination with this immunomodulator     is capable of decreasing the time to cure, and potentially increasing the cure rate, in     Andean cutaneous leishmaniasis. The present study will evaluate the combination of oral     miltefosine plus topical imiquimod for cutaneous leishmaniasis in Bolivia. If in the first     group of patients, cure rate at 1 month after therapy is appreciably above the 70% historic     value for miltefosine alone and the cure rate at 6 months is greater than the 88% historic     value for miltefosine alone, subsequent patients will be randomized between     miltefosine+imiquimod and miltefosine+placebo cream.   "
145482|NCT01380158|"     The primary objective of this study, is to determine the effect of a Cup pessary, a device     that is currently readily available in the USA and similar in design to the Arabin pessary,     on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous     birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length     prior to 23 weeks.   "
145471|NCT01380301|"     Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard     treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and     the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the     disadvantages of multiple injections and mild-moderate clinical toxicity all of which are     particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.      The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and     Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that     can be specifically attributed to the drug are nausea and vomiting of mild grade in     approximately 25% of patients, and low-grade elevation of creatinine also in approximately     25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks     have not been evaluated for cutaneous disease.      Combination therapy is now being used for many infectious diseases, such as tuberculosis,     malaria, and HIV. Combination therapy offers the potential of preventing drug resistance,     because organisms resistant to one of the drugs may be susceptible to the other drug; and     also the potential to diminish drug therapy duration and thus side effects. These two     potential benefits to some extent contradict each other: preventing resistance is best done     if full courses of both drugs is used; diminishing therapy duration means using less than the     full course of each drug. The optimum combination regimen is one in which sufficient amounts     of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare     patients unnecessarily long courses of drug.      In the present protocol, the combination of a half-course of miltefosine and a half-course of     antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and     antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the     combination was additive to mildly synergistic against a standard leishmania strain.   "
145472|NCT01380288|"     The purpose of this study is to evaluate and compare the changes of cognitive function (as     measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated     with and without white matter changes after rivastigmine patch therapy.   "
145473|NCT01380275|"     The purpose of this study is to estimate the control rate (CR,PR,SD) of docetaxel and     irinotecan (DI) combination chemotherapy for recurrent or refractory bone and soft tissue     sarcomas.Al so, this study is to evaluate the toxicity profile of Docetaxel and Irinotecan     (DI) combination chemotherapy.   "
145474|NCT01380262|"     Up to 60% of patients with metastatic colorectal cancer can be treated with one of monoclonal     antibodies targeted against epidermal growth factor receptor (EGFR). This treatment is     associated with a specific spectrum of toxicity: acne-like rash from limited up to erythema,     often with severe pruritus, sometimes combined with other types of skin toxicities (hair and     nail changes). Previously in STEPP study investigators shown that pre-emptive treatment with     oral doxycycline (200 mg daily), topical steroids and sun blockers reduces the number of more     severe skin side effects of panitumumab.      The study is designed to described the profile of skin toxicity of EGFR blocking drugs     combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.   "
145475|NCT01380249|"     This phase I study in adult patients with advanced solid tumours is designed to evaluate     toxicity, drug exposure (pharmacokinetics) and drug action (pharmacodynamics) of a new     molecule, PDM08, administered twice a week cycles of 4 weeks. This drug has shown antitumoral     activity in several murine cancer models.   "
145476|NCT01380236|"     The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when     given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe     asthma.   "
145477|NCT01380223|"     This study will assess the safety, tolerability, and pharmacodynamics of omecamtiv mecarbil     infusion in healthy male volunteers.   "
145561|NCT01379196|"     The purpose of this study is to examine the effects of Azithromycin (a macrolide class     antibiotic), given three times weekly, for patients with active moderate-severe, non     sight-threatening, Graves Orbitopathy.      Indices for follow-up will include:        -  Clinical activity score        -  Anti-TSH receptor antibody levels        -  Thickening of extraocular muscles per ultrasound        -  Quality of life score for Graves Orbitopathy patients   "
145478|NCT01380210|"     Carbon dioxide intoxication is a rare condition and only few case reports are found in the     literature. There were six patients who suffered from carbon dioxide intoxication in our     hospital about two years ago. Two of them are more severe with conscious change and brain MRI     studies of the two patients were performed. Reviewing the literature, no any report has     mentioned about the encephalopathy associated with carbon dioxide intoxication. We want to     review the brain lesions on the diffusion weighted images and the laboratory data of the     patients for further diagnostic help.   "
145479|NCT01380197|"     The pathophysiology of sickle cell disease (SCD) manifestations, are complex with     interactions of intracellular hemoglobin, membrane and endothelial activation but the     hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes     are thought to result from ischemia caused when small blood vessels are occluded by     misshapen, inflexible erythrocytes. Painful episodes are the most common cause of     hospitalization, morbidity, and impairment for SCD patients. There is no therapy that     completely prevents or directly aborts painful events for all patients. Consequently,     treatment for acute VOC is primarily supportive using hydration and medicinal pain control.     Every pain medication has the potential to relieve pain but is associated with significant     limitations and side effects.      The primary hypothesis to be tested in this double blind, randomized controlled trial is that     Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes     of acute chest syndrome. The investigators also expect subjects will report fewer side     effects from respiratory depression, abdominal distention from reduced peristalsis, reduced     histamine release causing pruritis and still be provided adequate pain control. Further     hypotheses to be tested is ability to recruit patient participants while being treated in the     Emergency Department and that continuous infusion of Nalbuphine with accompanying patient     controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total     opiates consumption, while decreasing length of hospitalization.   "
145480|NCT01380184|"     Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of     ridaforolimus after administration of single and multiple 40 mg doses in Chinese participants     with advanced cancer. Part 2 of the study is optional; participants can continue to receive     the study drug in a weekly regimen of daily oral doses of ridaforolimus 40 mg for 5     consecutive days followed by 2 days off-drug.   "
145481|NCT01380171|"     Children who are born with cleft palate need surgery in order to correct the problem. The     surgery is needed because the defect allows food to leak into the nose. It also causes the     patient to be unable to speak correctly, producing a problematic nasal sound. Sometimes the     first surgery does not completely correct the problem and a second surgery is needed. Looking     at the records of patients who have had corrective surgeries done in the past would allow the     surgeons to improve their success rate and reduce the need for secondary surgeries. It would     also create greater patient safety and reduce cost for families.   "
145483|NCT01380145|"     This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the     immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma     who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the     International Myeloma Working Group (IMWG) criteria and who were eligible for high-dose     chemotherapy with autologous stem cell transplant (auto-SCT). The primary objective was to     determine the safety and tolerability of immunizations when administered prior to stem cell     mobilization and multiple times after stem cell reinfusion. Secondary objectives were to     assess the humoral and cellular immunogenicity and clinical outcomes of immunization.   "
145484|NCT01380132|"     The purpose of this study is to determine whether anorectal application of Nasha Dx is safe     and effective for treatment of anal incontinence.   "
145485|NCT01380119|"     This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic     benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among     Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be     compared to placebo combined with standard ATT therapy. The trial will consist of one stage     with sputum evaluation at months 1 and 2.   "
145486|NCT01380106|"     This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in     combination with low dose dexamethasone in patients with relapsed multiple myeloma.      The investigators propose to use the need for dose reduction as a criterion to judge     tolerability from various causes. In the veteran population which predominantly is in the     older age category with number of co-morbidities, a lower dose regimen may be safer and     advantageous.      This study expects to enroll approximately 80 subjects from participating VA sites across the     nation.      The investigators will evaluate the safety of the two dose regimens by comparing frequency of     dose reductions. The investigators will also measure how long the responses last with each     dose.      Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of     specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for     patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM     are cancers of the blood. It is currently being tested in a variety of cancer conditions. In     this case it is considered experimental.      At the time of enrollment, one-half of the subjects will be chosen at random to receive the     15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide.     Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d.     or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will     be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose     reduction on the same schedule if the patient cannot tolerate the higher dose of     dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis.     Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended.     Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.   "
145487|NCT01380093|"     The primary purpose of this study is to determine the abuse potential of EMBEDA compared to     controlled release morphine when crushed and taken orally by non-dependent recreational     opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA     relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with     crushed controlled-release morphine and crushed placebo.   "
145654|NCT01377896|"     'Real life' retrospective patient cases (10) to provide an objective and robust analytical     report of patient management and prescriptions behaviours for Schizophrenia, Bipolar     disorders and Major depressive disorders.   "
145488|NCT01380080|"     People with HIV have a high chance of becoming infected with TB, especially when they live in     areas where TB infection is common. It can be difficult to diagnose TB in people who need to     start HIV treatment right away. Within about 6 months after starting HIV treatment, some of     these people can become very sick with TB and can even die from it.      This study is being done in people who are starting HIV treatment and who live in areas where     the TB infection rate is high. The purpose of this study is to test an experimental approach     to TB treatment to see if it is better than the usual approach. The experimental approach is     to start TB treatment at the same time as HIV treatment, even when TB infection has not been     found. The usual approach is to start TB treatment only if TB infection is found.      In this study, half of the people will start TB treatment at the same time as they start     their HIV treatment. The other half will start TB treatment only if TB infection is found.      The study will also test how safe and effective it is to start TB treatment at about the same     time as HIV treatment even when TB infection has not been found. The study will collect     information about diet, whether (and when) people in the study become sicker or die, how well     their HIV is controlled, how they are feeling, how they are taking their medications, whether     it matters where they live or what kind of HIV and TB care is standard, how many people are     diagnosed with TB while in the study, and how the cost of the two treatment options on a     national level could be compared.   "
145489|NCT01380067|"     laparoscopic hernia sac high-ligation        -  has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral          umbilicus ligament covering the hernia opening        -  The investigators developed a method of laparoscopic hernia repair by applying a new          concept in hernia repair. The hernia opening was tightened, and hernia opening region          repaired with a lateral umbilicus ligament in a tension-free manner. This method          combines the advantages of a secure repair achieved by the open method with the minimal          invasiveness of the laparoscopic method. The investigators hypothesized that the lateral          umbilicus ligament covering the internal hernia opening region after the laparoscopic          purse-string knot would result in lower recurrence and the same operation relative          complication.   "
145490|NCT01380054|"     The investigators aim to :        -  describe and analyse psychological characteristics, cognitive factors and          representations in patients with Pulmonary Hypertension, a rare disease.        -  assess the psychological characteristics impact on quality of life, check the          association between disease and QoL evolution, and the variability of QoL parameters          over severity class changes and follow-up   "
145491|NCT01380041|"     Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain     MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies     are also expected to improve MS care. Cytokine arrays provide measure of many different     inflammation-related molecules that could help understanding the disease. Moreover,     individual prognosis could be linked with the level of such molecules in the CSF of MS     patients. The investigators will analyze the cytokine profile of MS and control patients CSF     to determine a specific profile of MS and look for prognosis implication in a cohort of     patients with clinically isolated syndromes (first manifesatation of MS).   "
145770|NCT01376349|"     RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer     survivors.      PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to     placebo in treating postmenopausal cancer survivors with vaginal symptoms.   "
145492|NCT01380028|"     The chronic subdural hematoma is a common disease in the population over 60 years. For     example, in patients over 70 years, it occurs every year 7 new cases per 100,000 people. A     chronic subdural hematoma is an accumulation of blood in the intracranial space between brain     membrane (dura mater) and the brain. The origin of blood in this area follows a minor brain     injury, which causes the rupture of small vessels in the area. During its evolution, the     volume of the hematoma increases. After a few weeks, the amount of fluid build-up can     compress the brain. That's when clinical symptoms occur: persistent headaches, neurological     deficits, seizures, impaired consciousness, cognitive functions (memory loss, impaired     intellectual function, or hallucinations, etc.). The compression of the brain may cause     impairment of consciousness resulting in more severe cases coma and death. At this stage, a     neurosurgical intervention is necessary. Recurrences are numerous (15 to 25% recurrence over     six months after neurosurgery). That is why in France, about 20% of medical teams administer     a postoperative treatment with corticosteroids to reduce the risk of recurrence. Until now,     the potential benefit of this treatment has not yet been confirmed by a clinical study. So     the purpose of this research.   "
145493|NCT01380015|"     The purpose of this study is to investigate the benefits of daily consumption of a high     rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain,     physical function and disease activity in osteoarthritis of the knee.      The investigators hypothesize that a spearmint tea high in rosmarinic acid is efficacious in     mitigating the symptoms of osteoarthritis of the knee through its actions in reducing     cartilage degradation, oxidative stress and inflammation.   "
145494|NCT01380002|"     -  Liver/renal transplantations are now tending to be the most important treatment for          terminal liver and renal disease. Although transplantation can prevent recipients from          suffering with critical and fatal symptoms, patients may experience the complication          from surgery and immunosuppressive drugs. Furthermore, they might have many unmet needs          in daily life, and so as their spouses. The purpose of this study is to explore the          home-care needs among the post liver or renal transplant recipients and their spouses,          and identify the significant factors for care needs.        -  A cross-sectional correlated design will be used and patients will be recruited by          purposive sampling from an organ transplant outpatient department at a medical center in          northern Taiwan. A set of structured questionnaires will be used to collect data.        -  The result of this study will be helpful for clinical nurses to understand liver or          renal recipients' physical and mental distress, also identify the potential risk of          home-care needs and the degree of satisfaction as well.   "
145495|NCT01379989|"     The objective of this multicentric, randomised, Phase III study is to demonstrate     superiority, in terms of prolonged survival, of trabectedin and Pegylated Liposomal     Doxorubicin (PLD) versus carboplatin and PLD.      Patients will be randomised to:      Arm A: PLD 30 mg/m2 and carboplatin AUC 5 Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2     Patients'/subjects' characteristics: patients over 18 years of age with advanced, progressive     ovarian cancer 6-12 months after completion of first line treatment with platinum-based     chemotherapy.   "
145496|NCT01379976|"     Study objectives Primary: To compare toxicity free survival of patients treated with ALC     (acetylcarnitine) plus cisplatin-containing chemotherapy (CHT) versus those treated with     placebo plus cisplatin-containing chemotherapy.      Secondary: To compare progression free survival, overall survival, the compliance to     treatment, the number of episodes of grade 3-4 National Cancer Institute Common Terminology     Criteria for Adverse Events, version 3.0, neurotoxicity, as well as the proportion of     patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for     Adverse Events, neuropathic pain intensity, the clinical signs and/or symptoms (such as     burning, numbness, itching, etc.) of the sensorial neuropathy between the two treatment arms.     Study design Multicentre, randomised, double-blind, placebo-controlled, phase III,     superiority study in patients with advanced or metastatic NSCLC (non small cell lung cancer).      Patients to be screened for study inclusion are those for which the decision to start a     cisplatin-containing treatment has been already taken in the context of the clinical     practice. The type of cisplatin-based treatment is not fixed, but each single investigator is     free to choose for each single patient among those already approved for first line treatment     of advanced or metastatic NSCLC.      Patients meeting the eligibility criteria will be randomized with a 1 : 1 ratio to receive     ALC + cisplatin-containing CHT or Placebo + cisplatin-containing CHT until patient refusal,     disease progression, unacceptable toxicity or death. The study will be conducted in Italy in     approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month     period.      Both efficacy and safety data will be collected. Follow-up will be according to the clinical     practice. Data capture will continue, for each patient, until death or study closure.   "
145497|NCT01379963|"     This retrospective observational study will evaluate the hemoglobin levels in patients with     renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).   "
145498|NCT01379950|"     There is a growing body of evidence to suggest that the resolution of an inflammatory     reaction is an active process. This process requiring signals that turn off early     inflammatory stages, as neutrophil infiltration and promote resolution phase, as clearance of     apoptotic cells. In this array,the relationship between neutrophils, monocytes, and     macrophages is crucial for the concert process.      Macrophages possess a plasticity of phenotype that explains their protective as well as     potentially detrimental role in chronic inflammation and tissue injury. Such heterogeneity     arises as macrophages differentiate from monocytes and are exposed to specific tissue- and     hematopoietic cell-derived stimuli. It is important to be able to identify the different     types of macrophages in this setting. Today's literature can distinguish between 3 main     phenotypic groups of macrophages. The classically activated M1 macrophages, the alternatively     activated-M2 macrophages and the resolution phase - rMs macrophages. The third phenotypic     macrophage might play a crucial rule in the resolution phase, and is called the resolving     macrophage.      All of those pro-resolving lipid mediators promote the return to tissue homeostasis .      The investigators hypothesis is that in periodontal patients the inflammatory process     continues because the process does not reach the resolution phase, and in that milieu, the     macrophage might be a key component.      Within the overall concept of periodontal disease as a model for an inflammatory disease with     an stoppable inflammatory reaction, the primary aim of the study is to check the macrophage     characteristics in periodontal patients and to compare it to healthy people.   "
145499|NCT01379937|"     The purpose of this study is to assess the safety and immunogenicity of a prime-boost     schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.   "
145584|NCT01378897|"     The purpose of this study is to evaluate a new educational program for people who have     recently had gastric bypass surgery. This program involves both the use of newly developed     wireless home monitoring technology (medication box, weight scale, and pedometer) and     telephone-based, individually tailored health counseling with a bariatric dietician.   "
145500|NCT01379924|"     1. Specific Aims        1. To evaluate the effects of life skills/parenting groups that are embedded within a          comprehensive multidisciplinary clinic for adolescent parents (the Young Parents          Program), using a randomized control design. Specifically, the effect of group          participation on the following adolescent parent outcomes will be investigated:             -  Parenting attitudes and skills including empathy, non-violent discipline, role               appropriateness and developmentally appropriate expectations.             -  Skills of daily living, social relationships, and work/study at follow-up, as               measured by the Ansell-Casey Life Skills Assessment Scale.             -  Depression and perceived social support using the CESD-C and Duke Social Support               scale.             -  Repeat pregnancy rates at 12 and 24 months after first delivery.        2. To evaluate the overall Young Parents Program service delivery as required by the Office          of Adolescent Pregnancy Programs (project funder) using a cross cutting evaluation of          health services utilization, social needs and work/educational outcomes.   "
145501|NCT01379911|"     Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming     food. Being able to effectively measure satiety is an important concept that has implications     in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is     recognized a useful strategy for weight management. Recently, the category of foods marketed     as having satiating effects has seen significant growth and this trend is expected to     continue. The purpose of this project is to develop and validate methods for assessing the     degree of satiety induced by foods and natural health products using commercially available     food products.      This trial will examine the effects of a commercially available yogurt (containing added     protein and fibre) on self-reported satiety and hunger, as well as food intake in both     controlled and uncontrolled settings.   "
145502|NCT01379898|"     -  Rationale: The optimal preoperative medical management for patients with a          pheochromocytoma is currently unknown. In particular, there is no agreement with respect          to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor antagonist          to be administered before surgical resection of a pheochromocytoma. We hypothesized that          the competitive alfa1-antagonist doxazosin is superior to the non-competitive alfa1- and          alfa2-antagonist phenoxybenzamine.        -  Objective: comparing effects of preoperative treatment with either phenoxybenzamine or          doxazosin on intraoperative hemodynamic control in patients undergoing surgical          resection of a pheochromocytoma.        -  Study design: Randomised controlled open-label trial.        -  Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign          pheochromocytoma.        -  Intervention: Patients are randomised to receive oral treatment with either          phenoxybenzamine or doxazosin preoperatively.        -  Main study parameters/endpoints: The main study parameter is defined as the percentage          of intraoperative time that blood pressure is outside the predefined target range after          pretreatment with either phenoxybenzamine or doxazosin.      In this multicenter trial, we compare the effects of two commonly used drugs in patients     being medically prepared for resection of a benign pheochromocytoma. Participants are not     subjected to an experimental treatment of any kind, as we merely aim to describe in detail     the perioperative course in general and, in particular, the intraoperative hemodynamic     control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A     routine diagnostic work-up for pheochromocytoma will be performed in all participants. One     extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and     participants need to record their symptoms in a diary. In addition, patients who are     pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with     an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least 2     - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment with     an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by the     nursing staff. The final site visit is planned at 30 days after surgery, in line with current     practice.   "
145576|NCT01379001|"     This research study will look at how medications affect the pattern of blood flow in the     brain. This study will use a special type of MRI (magnetic resonance imaging) scan called     perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will     use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine     (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive     testing will also be obtained, and correlated with the blood flow patterns in the brain.   "
145503|NCT01379885|"     The purpose of this study is to compare the effectiveness of a more feasible method for     reducing the pain and distress of childhood immunization with the standard method in use at     the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental     involvement on the parent and child satisfaction with the immunization experience.      Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there     will be no statistically significant group differences between PPT and ST with respect to:        1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary          outcome);        2. Parent report of child pain using the FPS-R;        3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and          Consolability (FLACC) scale14;        4. Parent and child satisfaction with pain management during immunization measured by a          5-point Likert type scales;        5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes          after completion of the last injection.   "
145504|NCT01379872|"     The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of     Health and Ageing to undertake a project to assess new Radiation Oncology Technology and     Treatments. This project is being undertaken in response to a recognised need for the     Medicare Benefits Schedule to support appropriate new radiation oncology technologies and     treatments as they become available, to ensure optimal patient care.      The first phase of the project required TROG to develop a Generic Research Framework (the     Framework) capable of collecting and generating information to substantiate the safety,     clinical efficacy and cost effectiveness of new technologies and treatments.      The second (and current) phase of the project requires that the Framework be piloted to     assess the safety, clinical efficacy and cost effectiveness of Intensity Modulated Radiation     Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) in four tumour site specific     regions:      A. Post Prostatectomy(IMRT) B. Anal Cancer (IMRT) C. Nasopharynx (IMRT) D. Intermediate Risk     Prostate Cancer (IGRT)      The aims of the site specific components of the ANROTAT protocol are as follows:      Protocol A. Develop an approach for applying the Framework to evaluate the safety, clinical     efficacy and cost-effectiveness of IMRT compared to 3DCRT in patients with prostate cancer     (PP).      Protocol B. Develop an approach for applying the Framework to evaluate the safety, clinical     efficacy and cost-effectiveness of IMRT compared to 3DCRT in AC.      Protocol C. Develop an approach for applying the Framework to evaluate the safety, clinical     efficacy and cost-effectiveness of IMRT compared to 3DCRT in NPC.      Protocol D. Develop an approach for applying the Framework to evaluate the safety, clinical     efficacy and cost-effectiveness of IGRT compared to non-IGRT in patients with intermediate     risk prostate cancer.   "
145505|NCT01379846|"     The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when     administered to healthy Japanese infants as multiple subcutaneous doses.   "
145506|NCT01379833|"     Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a demyelinating chronic     progressive or relapsing neuropathy believed to be secondary to an autoimmune response     against peripheral nerve antigens.5 We have observed two patients with CIDP with decreased     corneal sensation who also suffered neurotrophic corneal ulcers and severe visual loss in the     affected eyes. We want to explore the relationship of CIDP and corneal sensitivity. Our     hypothesis is that people with CIDP have decreased corneal sensation compared to those     without. We plan to perform a prospective study measuring corneal sensation in patients     (proposed n=10) with CIDP and without to determine (1) if a difference exists in patients     with CIDP compared to controls and (2) the magnitude of the difference. If a difference is     detected in corneal sensitivity in patients with CIDP, this awareness amongst physicians and     patients may help prevent blinding complications.   "
145585|NCT01378884|"     The purpose of this study is to determine whether domperidone can be used safely and     effectively for patient with gastroparesis.   "
145507|NCT01379820|"     Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of     pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the     pressure in the airway is variable, the investigators evaluate a closed system with a     intubated baby with a orotracheal system but with a elastic reservoir , the reservoir distend     and the pressure in the airway is constant ,with this system the investigators protect the     lungs for damage . The investigators want compare the use of nasal CPAP, mechanical     ventilation and orotracheal CPAP with a compensation bag (gregory system) in newborns with     respiratory failure .   "
145508|NCT01379807|"     The clinical hypothesis of this study is that the addition of Panitumumab to the first line     treatment combination of docetaxel plus cisplatin will provide benefit to patients with     advanced gastric or gastroesophageal junction adenocarcinoma.   "
145509|NCT01378754|"     Interstitial cystitis is a condition where a defect in the protective lining of the bladder     causes the urinary symptoms such as urgency, frequency and pain/burning on urination. One way     to help ease the symptoms of this disease is to fill the bladder full of water every 4 to 6     months.      Since this is a painful procedure an anesthesiologist will give you a drug that will make you     unconscious for the procedure. General anesthesia can be given to you through an IV tube that     is placed in a vein in your arm. There are only a few agents that induce sedation and these     agents have certain disadvantages such as waking up slowly, low blood pressure, and pain at     the injection site and a prolonged time to consciousness.      This study will be comparing doses of a new IV sedation induction agent drug to put you to     sleep called fospropofol (Lusedra®).   "
145510|NCT01378741|"     The objective of this study is to reduce the incidence of postoperative delirium after     cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce     delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation     protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist     (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource     utilization analysis will be performed to determine cost effectiveness of the new treatment     modality.   "
145511|NCT01378728|"     The primary objective of this clinical study is to evaluate the use and effectiveness of our     'handheld' fluorescence digital imaging device platform for real-time non-invasive clinical     monitoring of chronic wounds for healing and bacterial contamination/infectious status over     time. This will enable us to determine if the device can detect and longitudinally track     intrinsic changes that may occur during the wound healing process including, but not limited     to, collagen re-modeling and bacterial infection of the wound site.   "
145512|NCT01378715|"     The aim of this study is to determine whether a pre-treatment with high-dose statin (one day     prior and just before intervention, rosuvastatin 20mg/day) has a positive impact on the     occurrence of periprocedural myocardial infarction during percutaneous coronary intervention     (PCI).   "
145513|NCT01378702|"     The objective of this clinical trial is to describe safety, tolerability and the course of     parameters of the immune system during administration of different doses of two     subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta     tota) in healthy volunteers, compared to placebo.   "
145577|NCT01378988|"     The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety     of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through     <24 months, administered as an intravenous loading dose followed by continuous infusion for a     minimum of 6 hours and up to 24 hours in an intensive care setting.   "
145514|NCT01378689|"     This quality improvement project is aimed at improving health care by identifying low cost     strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with     their physicians about osteoporosis prevention and treatment (improving doctor-patient     communication). The investigators will implement a direct to patient intervention to the     population of interest (patients on chronic glucocorticoids) via story-telling, using an     Internet based video. The target audience is people on chronic glucocorticoids not already     receiving bones-specific osteoporosis medications to determine differences in     post-intervention rates of osteoporosis care, and the rates of prescription anti-osteoporosis     therapies.   "
145515|NCT01378676|"     The study will generate data on safety and tolerability after multiple daily doses of     CK-2017357 in patients with ALS. Patients will be randomized into one of four different     treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of     CK-2017357 for 14 days.   "
145516|NCT01379781|"     Postpartum depression (PPD) is undertreated and the consequences of this are substantial for     women and children. Studies show that infant cry/fuss and sleep behavior are associated with     PPD, and that parenting interventions can change infant behavior, yet these findings have     never been applied to PPD. In this study, the investigators are teaching parenting skills to     increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD     to see if the investigators can prevent the onset of this disorder.   "
145517|NCT01379768|"     The purpose of this study was to count and analyze the white blood cells in tear samples     collected from study participants following sleep. The results from contact lens wearers were     compared with the results from non-contact lens wearers.   "
145518|NCT01379755|"     This is a comparison of the functional results and Varus-Valgus Stability in Single-radius     versus Multi-radius Femoral Component for Total Knee Arthroplasty.   "
145519|NCT01379742|"     This study will investigate health related quality of life factors in patients undergoing low     dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for     use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel,     sexual function and bother will be measured by the EPIC questionnaire at various time     intervals.   "
145529|NCT01379612|"     The aim of this study is to recruit 50 rectal cancer patients planned to receive standard     radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy     and followed by re-scans two and six weeks after initiation of treatment. The objective     quantitative elastography findings are compared with the TRG score.      The purpose is to elucidate ultrasonic elastography's ability to predict treatment response     at an early stage by comparing quantitative ultrasound parameters before, during and after     treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after     operation.   "
145520|NCT01379729|"     Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT.     Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during     hyperglycemic clamp at 180 mg/dl.      The investigators hypothesize that functional beta-cell mass will be more than 20% compared     to healthy controls.      Secondary outcome measurements:      Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.      The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against     base-line (base-line = before first intraperitoneal transplantation):        -  metabolic control        -  safety parameters        -  episodes of hypoglycemia        -  islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and          alloantigens using pre-transplant measurements as base-line The investigators          hypothesize that metabolic control and prevalence of hypoglycemia, will be significantly          improved till PT month 12.      Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time     of the second implant. Comparison with composition of graft, identification of     microenvironment of host origin and correlation with functional assessment will be performed.   "
145521|NCT01379716|"     Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are     damaged following an outbreak of shingles.      The purpose of this study is to identify and study abnormalities in the nerves and cells in     the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be     responsible for causing nerve pain. This data will be compared to the tissue of healthy     volunteers. Our goal is that this information will lead to the development of better     treatment options for people with painful nerve conditions.   "
145522|NCT01379703|"     KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which     lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the     local marketing authorization with regards to dose, population and indication. No additional     procedures (other than the standard of care) are to be applied to the patients.      The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter     format. The study was carried out in two (2) parts: the first part was initiated in 2004 with     the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the     lopinavir/ritonavir tablets had become available in the participating countries.      The aim of this post-marketing observational study was to obtain further data on clinical,     biological, and virological outcomes, compliance and tolerability of Kaletra®-containing     regimen during routine clinical use in the participating countries.   "
145523|NCT01379690|"     Type 2 DM patients are at increased risk of falls as a consequence of long term hyperglycemic     complications including retinopathy and neuropathy, and also as a result of hypoglycaemic     therapy. Values of A1C <= 7% has been shown to increase the risk of falls in elderly T2DM     patients .      Increased fall risk may explain why T2DM patients are at increased risk of hip fractures ,     despite having a higher bone mineral density as compared to non-T2DM patients. Given the high     morbidity and mortality (25% mortality in 1st year post-fracture) associated with hip     fractures , all care must be given to prevent hip fractures in T2DM patients.      There is controversial data on T2DM medications and fracture risk. Vestergaard showed that     use of metformin and sulphonylureas decreased the risk of all fractures, while there was     there was a similar trend with insulin.      The present study sought to evaluate the relationship between A1c values and the risk of     fractures in treated patients with T2DM.   "
145524|NCT01379677|"     The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82     PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).   "
145549|NCT01379352|"     The vecuronium requirements may be reduced for recipients of living donor liver     transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the     requirements may be different according to the phase of surgery. The requirements may also be     different according to the preoperative hepatic function as measured by MELD score during     prehepatic phase, or graft to recipient body weight ratio (GRWR) during neohepatic phase.     Therefore, the investigators are trying to investigate the difference of vecuronium     requirements according to the phase of surgery or MELD score, GRWR.   "
145525|NCT01379664|"     Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile     anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble     but more expensive anesthetic sevoflurane. Even a small reduction in the duration of     hospitalization would easily compensate for the modest additional cost of sevoflurane. The     investigators therefore propose to test the primary hypothesis that duration of     hospitalization is longer with isoflurane than sevoflurane.      The investigators will also test the secondary hypotheses that: 1) pain scores are greater in     patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption     is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be     adjusted for age, gender, race, baseline risk, 9 and procedure.   "
145526|NCT01379651|"     To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in     inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe     IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental     exposure to egg.   "
145527|NCT01379638|"     The purpose of this study is to determine whether the patients cardiac output measured before     cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the     estimated cardiac output from Ficks principle, and thereby prevent organ failure.   "
145528|NCT01379625|"     Humans eat long-chain fat in their diet and use it for energy during exercise and during     periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use     dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with     exercise or illness. They can also develop a heart that does not function properly. These     patients are tired and expend less energy than people who do not have a long-chain fatty acid     oxidation disorder. However, they can use a supplement oil called medium chain triglyceride     or MCT. This study will determine if a new experimental oil called Triheptanoin can decrease     the muscle pain and increase the heart function and the amount of energy in patients with     long-chain fatty acid oxidation disorders. Funding source - FDA's OOPD   "
146026|NCT01372930|"     Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin     concentration after myocardial infarction/reperfusion and also beneficial for the patients     undergoing percutaneous coronary intervention (PCI).   "
145530|NCT01379599|"     The goal of the proposed project is to determine the effectiveness of a brief motivational     intervention among Emergency Department (ED) patients who use cocaine and/or heroin to     prevent Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) by     comparing cumulative incidence and frequency of safe sex behavior between intervention and     standard voluntary counseling, testing and referral to substance abuse treatment (control)     groups over a one year follow-up period.   "
145531|NCT01379586|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-4053     across ascending single and multiple doses in healthy adult male and female subjects. The     secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053     in healthy adult male and female subjects.   "
145532|NCT01379573|"     Women with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a     child with a life threatening heart condition regardless of whether they have very active     lupus, are in remission, or have only vague symptoms. This heart problem is referred to as     congenital heart block (the most serious being third degree complete block) and represents     damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and     almost all children require permanent pacemakers before the age of 20. Importantly, women who     have had one child with heart block have a ten-fold higher risk of having another child with     the same heart condition. Unfortunately, even close monitoring by special techniques during     pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed     at prevention are critical. This study will evaluate for the first time whether     hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this     heart condition. Data from laboratory experiments suggests that this drug, which crosses the     placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the     fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage 1     and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on     hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that     fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur     out of all 54 patients if Stage 2 is reached. The results of this study are expected to     become an integral part of the counseling of women with anti-Ro/La antibodies who are     considering pregnancy.   "
145533|NCT01379560|"     The purpose of this study is to determine the pharmacodynamics of ocular blood flow     measurements with multiple drop unoprostone isopropyl administration versus placebo in     subjects with dry age-related macular degeneration (AMD).   "
145534|NCT01379547|"     The trial is aimed to show that implementation of a procalcitonin-guided antibiotics     algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior     outcome as compared to the conventional therapy   "
145535|NCT01379534|"     This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study     to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either     FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.   "
145536|NCT01379521|"     This study will evaluate the role of everolimus in combination with local Transcatheter     Arterial Chemoembolization (TACE) procedure in patients with localized unresectable     Hepatocellular Carcinoma (HCC).   "
145550|NCT01379339|"     The primary objective of this study is to determine the first-cycle maximum tolerated dose     (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and     Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of     the head and neck for three cycles.   "
145905|NCT01374555|"     The study is designed to evaluate the predictive accuracy of the CardioSond digital     electronic stethoscope in the detection of coronary artery disease (CAD) in patients with and     without known disease who are referred to cardiac computed tomography angiography (CT scans).   "
145537|NCT01379508|"     The purpose of this study is to evaluate the efficacy and safety following the Roadmap     Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg     negative CHB patients. The data from the study should allow for the validation of the Roadmap     concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative     CHB patients. As part of a post-approval commitment to the European Health Authorities, the     data will also be used to provide an optimized clinical treatment strategy for better     clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from     the study will contribute to a better scientific understanding, disease management and     treatment of HBeAg negative CHB patients.   "
145538|NCT01379495|"     The purpose of this study is to assess the effect of an educative program including telephone     follow-up for burn patients regarding the impact of this intervention on the health status     and return to work at six months after hospital discharge.   "
145539|NCT01379482|"     The aims of this study are to investigate whether multimodal treatment of peritoneal     carcinomatosis from gastric cancer is feasible and to evaluate the clinical outcomes and     clinical effectiveness of neoadjuvant systemic chemotherapy followed by cytoreductive surgery     + hyperthermic intraperitoneal chemotherapy + early postoperative intraperitoneal     chemotherapy, as compared to systemic chemotherapy only, in patients with peritoneal     carcinomatosis from gastric cancer.   "
145540|NCT01379469|"     The primary objective is to determine if the medication Carbamazepine, can be used as a     therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .   "
145541|NCT01379456|"     To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6     months after the fracture. The investigators hypothesis is that exercises performed after the     initial rehabilitation, which focuses on specific components of gait control will improve     gait and increase level of activity.   "
145542|NCT01379443|"     The objective of the study is to compare the usual care and treatment of children and youth     (0-19 years) with multiple developmental delays and disabilities and their families in Simcoe     York with a co-ordinated, navigated approach to care using the Children's Treatment Network     (CTN) services.   "
145606|NCT01378520|"     Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter     the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases     blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce     ratings of breathlessness induced by resistive breathing loads.   "
145543|NCT01379430|"     The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and     MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The     regime proposed in this trial has protected non-immune volunteers against sporozoite     challenge in clinical trials performed by Oxford, and so may be protective against naturally     acquired infection in Kenya.The study population will comprise 30 healthy adult males aged     18-50.      The investigators do not propose to include a placebo group. At this stage the investigators     objective is to describe the safety profile in a small number of individuals, and the     confidence intervals for the proportion of individuals with a particular event would be too     wide for meaningful comparison with a placebo group. Immunogenicity will be judged by     comparison with baseline.   "
145544|NCT01379417|"     The main objective is to assess the nutritional benefit of probiotics supplementation on     premature infants growth. As secondary objectives, different parameters related to probiotics     tolerance will be measured.   "
145545|NCT01379404|"     Patients with severe infections initially require large amounts of fluid as part of     resuscitation. Later on however, problems may arise from excess fluid such as increased time     on a ventilator and kidney damage. The amount of fluid a patient has is difficult to assess.     One approach is to determine the amount of fluid that is present in a large central vein.     This can be done by physical examination of the jugular veins, or by placing a catheter     within the vein. Unfortunately this method is unreliable and does not predict the amount of     fluid a patient has.      Bioimpedance analysis (BIA), is a device that can determine the amount of fluid in the body     by measuring the body's electrical properties. It is a quick and painless test that assesses     volume. The primary objective of this study is to determine if BIA measurements are     associated with patient important outcomes such as time on a ventilator, risk of kidney     failure requiring dialysis and death. We will also determine whether BIA is a measure of     fluid status in ICU patients. This study will assess feasibility in establishing a     multi-centre study assessing if BIA's role in predicting adverse outcomes and thereby     prognosis and fluid status. We hypothesize that shorter vector lengths will be associated     with hypervolemia and less ventilator free days.   "
145546|NCT01379391|"     Factors influencing platelet engraftment after allogeneic hematopoietic stem cell     transplantation (Allo-HSCT) includes previous chemotherapy courses, conditioning regimen, HLA     compatibility, source of stem cell, CD34+ cell count, infection of virus/bacteria/fungal,     graft-versus-host disease (GVHD), etc. Large-scaled clinical trials have demonstrated that     platelet count below 20G/L on 14 days after transplantation is an predictive factor for     delayed platelet engraftment, which lead to increased platelet infusion requirement and high     risk of bleeding. Multivariable survival analysis indicated that delayed platelet engraftment     in Allo-HSCT is independent predictive factor for transplantation related mortality (TRM).     But effective treatment approaches for delayed platelet recovery after Allo-HSCT are still     lacking now.      Recombinant human thrombopoietin (rHuTPO) is a fully modified recombinant human     thrombopoietin accurately expressed in mammalian cells. The rHuTPO agent manufactured by the     3Bio Pharmaceutical Limited Liability Company (LLC) in Shenyang is approved by the State Food     and Drug Administration (SFDA) of China in 2005 and is the first rHuTPO agent available     globally. RHuTPO was approved for for immune thrombocytopenia and chemotherapy-related     thrombocytopenia in China. Animal experiments showed that TPO-mobilizing stem cell could     promote platelet engraftment in Allo-HSCT in mice. As for efficacy and safety of TPO on     platelet engraftment after Allo-HSCT, it's marginally addressed in clinical trials.      Based on preliminary research results, investigator designed a phase IV, open-label,     prospective, multicenter Study of the efficacy and safety of recombinant human thrombopoietin     injection (rHuTPO, TPIAO)on platelet engraftment in Allo-HSCT in China.   "
145547|NCT01379378|"     The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier     to sexual satisfaction/frequency/desire and if surgical correction of incontinence will     improve these aspects of sexual health.   "
145548|NCT01379365|"     This is a prospective, non-randomized study to evaluate the performance of the MyoScience     Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.   "
145551|NCT01379326|"     Objectives:      The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted     Helminths (STH).      The primary objective is:      (1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against     Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR) and     Cure Rate (CR).      The secondary objectives are:        1. to assess the occurrence of Necator americanus and Ancylostoma duodenal.        2. to assess the occurrence of β-tubulin mutations related to resistance before and after          drug administration.        3. to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.   "
145552|NCT01379313|"     In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the     disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure.     The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on     pulmonary gas exchange by randomized controlled trial.   "
145553|NCT01379300|"     This is a study to investigate biomarkers after single oral doses of the anticoagulant agents     dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly     subjects.   "
145554|NCT01379287|"     Iso-fludelone is a type of chemotherapy drug called an epothilone. Epothilones are drugs that     attach to proteins in your body called tubulins. Tubulins help cells to grow, and are found     in both normal and cancer cells. When research animals with cancer were given the study drug,     Iso-fludelone, the drug attached itself to tubulin and slowed or stopped the cancer cells     from growing. Other types of epothilones have been tested in cancer patients and were found     to be safe. A similar epothilone drug and other drugs called taxanes are currently approved     by the FDA for treating certain types of cancers.      The purpose of this study is to see the effects, good and/or bad, of this investigational     drug, Iso-fludelone, on cancer. The term investigational means the study drug being tested     has not been approved by the United States Food and Drug Administration (FDA) or other     regulatory agencies. This study is the first time the investigators are using iso-fludelone     in people. This is a Phase I study. In a Phase I study, the first people to receive the drug     are given a fairly low dose.   "
145555|NCT01379274|"     This phase II study will evaluate the safety and efficacy of combining two active     agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of     patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale     for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination     therapy will result in higher response rates, and potentially longer response duration than     that achieved with either agent.      STUDY OBJECTIVES:      Primary:      To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and     low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q     deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy      Secondary:      To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q     deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza®     (azacitidine), as defined by the IWG 2006 Revised Response Criteria   "
145556|NCT01379261|"     The purpose of this study is to determine whether treatment of patients suffering from     ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous     catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous     coronary intervention (PCI) result in a reduction in infarct size.   "
145557|NCT01379248|"     The purpose of this study is to examine the benefit of thrombus aspiration in patients with     ST-elevation myocardial infarction presenting late after symptom onset.   "
145558|NCT01379235|"     Background: The elderly population in western countries and in Israel is constantly growing.     Falls are one of the common problems among this population. Thus there is a need for falls     prevention exercise program to be offered in the different settings elderly reside. Most     methods for physical exercise are dedicated to muscle strengthening and improving balance by     strengthening external muscles. Pilatis exercise program focuses mainly on strengthening the     in-depth muscles. The advantage of this method is in its simplicity and availability. This     method is suitable also for special populations as patients in acute hospitalization. In this     study, the investigators will evaluate if the pilatis exercise can improve balance of elderly     population. Physical exercise usually improves the mood. Like any physical exercise, Pilatis     exercise has a mental advantage, therefore, this study will also examine if pilatis exercise     can improve quality of life of elderly population.      Working hypothesis and aims: Pilatis exercise will improve balance and stability     measurements, and quality of life among elderly population.      Methods: Randomized, prospective study among elderly patients aged 65 and above belonging to     Clalit Health Services primary care clinic . Participants of the intervention and control     group will receive a brochure that will include nutrition and healthy life style     recommendations. Intervention group: will receive 12 weeks of pilatis exercise 3 times a     week. The control group will be offered the same intervention at the end of the study period.     Balance evaluation will be performed using the: Tinetti Balance Gait Scale, Berg Balance     Scale, Multidirectional Reach Test, Timed Up and Go, Step execution test. The SF-36     questionnaire will be use to evaluate quality of life.      Importance: This study will examine the influence of pilatis exercise on balance among the     elderly. If findings will determine that pilatis does improve balance in the elderly, the     investigators can further examine pilatis's influence on falls prevention, and minimizing     falls damages.      Probable implications to the welfare and health of the aged population:      Improving balance, falls preventing and minimizing falls damages among elderly; improvement     in elderly quality of life.   "
145559|NCT01379222|"     The purpose of the study is to demonstrate the long term safety and effectiveness of the     Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic     aneurysms in a post-approval environment, through the endpoints established in this protocol.      The clinical objective of the study is to evaluate the long term safety and effectiveness of     the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related     Mortality (ARM).   "
145560|NCT01379209|"     The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to     evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients     undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment.      The study will be separated into two parts; a dose escalation phase to assess safety,     followed by a large expansion phase to further evaluate the pharmacologic effects of either a     Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of     RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include     higher risk patients and limit the unrelated donor transplants. After safety is established     in part 1 of the study, the second portion of the study will expand the enrollment criteria     and allow transplantation by either related or unrelated donors.      This study will endeavor to identify the dose range at which RGI-2001 has an acceptable     safety profile, at which biologic activity is observed, and to guide possible dose levels to     utilize in later phase studies based on biological activity.   "
146071|NCT01372345|"     The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000 mg     ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation     in healthy, adult, non-smoking subjects under fasting conditions.   "
145562|NCT01379183|"     Magnetic Resonance Imaging (MRI) has proven to be a valuable imaging technique for suspected     small bowel disease. This technique depends, in part, on adequate distension of the small     bowel. This is accomplished by administering large volumes of a non-absorbable oral contrast     material prior to the examination, which typically produces excellent distension of the     distal small bowel and stomach, but poor distension of the proximal small bowel. Erythromycin     is a common antibiotic that is known to promote stomach emptying and is used to treat     diabetics with gastroparesis (poor stomach emptying.) The hypothesis of this study was that     erythromycin will increase gastric emptying and hence improve small and large intestinal     distention during MRI.   "
145563|NCT01379170|"     Background of the study:      Thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to promote weight loss,     which could be beneficial for treating obesity, and type 2 diabetes. Thyroid hormone     treatment stimulates energy expenditure resulting in increased body heat production, in which     brown adipose tissue play an important role. It is hypothesized that thyroid hormones would     induce increased energy expenditure via a process called mitochondrial uncoupling, thereby     creating an inefficient energy status. Indeed, an in vivo study showed a 70% increased flux     through the tricarboxylic acid cycle (TCA) and an unchanged ATP synthesis rate upon T3     treatment in lean, healthy young men. The disproportionate increase in TCA flux compared with     ATP synthesis suggests increased mitochondrial uncoupling. It is however unknown whether     increased mitochondrial uncoupling would increase fat oxidation and exerts favorable effects     on insulin sensitivity. There is compelling evidence that type 2 diabetic patients have high     levels of fat accumulation in non-adipose tissues, such as skeletal muscle, heart and liver.     Ectopic fat accumulation is related to insulin resistance, however, why this fat accumulates     in peripheral organs is not known. Recently, studies reported compromised mitochondrial     oxidative capacity in type 2 diabetic patients and first-degree relatives of diabetic     patients, suggested to play an important role. Therefore, subjects suffering from overweight     and/or type 2 diabetes with overt hypothyroidism form an interesting group for examining the     metabolic effects of thyroid hormone treatment, as less is known about the effects of thyroid     hormone treatment in these groups.      Objective of the study:      The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type     2 diabetic patients suffering from overt hypothyroidism, will improve muscular mitochondrial     function, lower ectopic fat accumulation in muscle and liver, increase brown adipose tissue     activity and enhance insulin sensitivity.      Study design:      Type 2 diabetic patients diagnosed with hypothyroidism will undergo 3 months of thyroid     hormone replacement therapy (THRT) (Euthyrox®, Merck, Germany). Patients will be     metabolically characterized (such as insulin sensitivity and fat accumulation in peripheral     tissues) before and after this thyroid hormone replacement therapy.      Study population:      17 type 2 diabetic patients diagnosed with overt hypothyroidism (9 from the Netherlands, 8     from Germany which will only do the PET-CT)      Primary study parameters/outcome of the study:      Thyroid hormone-induced change in whole body insulin sensitivity (change in     insulin-stimulated glucose disposal) and muscle mitochondrial function.      Secondary study parameters/outcome of the study (if applicable):      Thyroid hormone-induced change of lipid content in skeletal muscle and liver and brown     adipose tissue activity.   "
145564|NCT01379157|"     Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against     Gram-negative and Gram-positive bacteria. This agent is often used as the last line of     therapy for highly resistant Gram negative bacilli nosocomial infections. In common with     other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that     correlates with the therapeutic efficacy is the time that concentrations in the tissue and     serum are above the MIC and administration by continuous infusion is the preferred mode of     administration to maximize this parameter.      However, in tropical countries, the stability of carbapenem antibiotics is an important     consideration when considering continuous infusion. Therefore, prolonged infusion may be a     useful mode of administration to maximize bactericidal activity. This study will demonstrate     the stability of imipenem in clinical use at room temperature in tropical countries.   "
145565|NCT01379144|"     The primary objective of this study was to compare the change in intraocular pressure (IOP)     of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50     ug/ml dose, in a dose ranging study.   "
145566|NCT01379131|"     Some myocardial infarctions (MI) occur as the first manifestation of atherosclerotic disease.     Such MIs are important because of the high likelihood of missed opportunities for prevention.     A recent analysis using CALIBER data estimated this proportion at 60%.      Further to this research, another level of complexity can be added to improve our     understanding of these MIs. This is the concept of a completely 'unanticipated' MI, which can     be defined as: MI occurring as the first manifestation of atherosclerotic disease and without     any traditional cardiovascular risk factors and without any prior chest pain. Such     'unanticipated' MIs cannot be foreseen by the medical profession and their frequency in the     population is unknown.      Therefore the aim of this study is to describe the distribution of previously diagnosed     cardiovascular disease, cardiovascular risk factors and chest pain in patients with first MI.     This will provide an estimate of the number of 'unanticipated' MIs and of the levels of risk     factors in unheralded, compared to heralded MI.   "
145567|NCT01379118|"     This study is to determine the relevancy of clinical scales for outcome measures as compared     to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee     Society Score and the WOMAC Score will be obtained from patients. Gait data will also be     obtained from total knee replacement (TKR) patients at pre-operative and post-operative     times. Gait data will be measured on unaffected normal controls as a second baseline.      The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait     dependent outcomes amd functional performance of the total knee replacement.   "
145568|NCT01379105|"     The objective of this experimental study was to compare the electromyographic responses of     sedentary youth with and without the administration of static stretching and neural     mobilization. The sample was composed of sedentary students, divided, randomly, into neural     mobilization practitioners (NMG; n=15; age=22±3 years), static stretching practitioners (SSG;     n=15; age=23±4 years) and a control group (CG; n=15; age: 24±4 years). For this evaluation,     an electromyograph (EMG; a four channel system) was used to monitor electrical activity in     the femoral bicep muscles). In neural mobilization, hip flexion was conducted passively with     the knee extended, and 30 plantar-to-dorsal flexion oscillations were completed per minute.     For the static stretching, hip flexion with was completed passively with the knee extended     and held for 6 seconds. The perception of effort was evaluated using the Perceived Force in     Flexibility Scale. The statistical significance level was p<0.05. Descriptive statistics such     as the average, standard deviation, median, standard error and absolute change within groups     (post-test - pretest) were calculated. The sample normality was evaluated using the     Shapiro-Wilk test. For the response variable analysis, the paired Student's t-test (paired)     or Wilcoxon test (nonparametric) was used for intragroup analysis. For the intergroup     analysis, the multivariate analysis of variance (ANOVA) test was used, followed by the Tukey     Post-Hoc test. A p<0.05 significance level was adopted for the statistical evaluations.     Microsoft Excel and the Statistical Package for Social Science (SPSS) version 14.0 were used     for evaluation of the results.   "
145569|NCT01379092|"     The objective of this study is to evaluate the image quality and operation of a     self-contained direct digital radiography system for breast specimen imaging.   "
145570|NCT01379079|"     Aspirin is a cornerstone in the secondary prevention of cardiovascular disease (CVD) and is     usually taken on awakening, although evidence regarding optimal time of intake is lacking.     Recent studies in healthy subjects with mild hypertension showed that aspirin at bedtime     decreases blood pressure (-7/5mmHg), whereas intake of aspirin on awakening does not.     Additionally, the investigators found that aspirin at bedtime decreases plasma renin     activity, catecholamines and cortisol over 24hrs. Time-dependent effects of aspirin have     never been studied in patients with CVD, who may use concomitant antihypertensive drugs.     Moreover, platelet reactivity has a circadian rhythm, and intake of aspirin at bedtime may     attenuate the morning peak in platelet reactivity. The investigators hypothesize that aspirin     intake at bedtime compared with on awakening decreases both blood pressure and platelet     reactivity over 24h.      A randomized open-label blinded endpoint crossover trial in which 250 patients, recruited     from primary care, will be included who use aspirin for secondary prevention of CVD and have     a stable blood pressure of 149/94mmHg or lower. Study subjects will randomly use both aspirin     on awakening and at bedtime during two intervention periods of three months. Blood pressure     will be recorded for 24hrs at the end of each treatment period in the patients' normal daily     situation. To assess effects on platelet inhibition, thromboxane-B2 levels will be measured     in a 24h urine sample at the end of both treatment periods. The investigators will asses     differential effects according to time of intake on gastrointestinal complaints and potential     minor bleeding events, as well as compliance.      The aim of this study is to evaluate the effect of aspirin taken at bedtime compared with on     awakening on blood pressure of subjects with stable CVD. In addition, it will generate     insights into the effect of aspirin on platelet reactivity over 24hrs, potential side effects     and compliance.   "
145580|NCT01378949|"     A psoas compartment block has been used with good results for postoperative pain relief after     total hip arthroplasty (THA). However, case reports describing serious complications after     the use of this block, have been reported. The fascia iliaca compartment block (FICB) has     been shown to be a reliable block for postoperative pain relief for procedures and injuries     involving the hip. The investigators have not found any literature that has compared these     two blocks. This study will compare the two blocks when used for post-operative pain relief     after THA.   "
145581|NCT01378936|"     The purpose of this study is to evaluate whether the Impact of Crime (IOC) group intervention     with jail inmates reduces post-release recidivism, substance abuse, and HIV risk behavior.   "
145582|NCT01378923|"     This is a pilot study to examine the acceptability and effectiveness of the Re-Entry Values     and Mindfulness Program (REVAMP), a group intervention for jail inmates. It is hypothesized     that REVAMP will reduce post-release recidivism, substance abuse, and HIV risk behavior.   "
145571|NCT01379066|"     The Pulmonary Colonization Test is a non-invasive breath test for markers of lower     respiratory tract infection, which may predict the probability of mycobacterial organisms in     the lower respiratory tract. It consists of:        -  A breath collection apparatus for collection of volatile organic compounds in breath          onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample          of room air.        -  Analysis of the volatile organic compounds in breath and room air by short acoustic          wave/gas chromatography.        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order          to predict the probability of lower respiratory tract colonization and infection.        -  Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas          chromatography.      This study will test the hypothesis that the investigators can identify the presence of     mycobacteria in an individual by sampling the breath of patients with active tuberculosis and     by sampling head space above culture media of sputum provided. This study will test the     hypotheses:        -  that the investigators can identify positive cultures for mycobacterium tuberculosis          through sampling of the headspace above the cultures prior to standard laboratory          culture identification        -  that the investigators can identify control of tuberculosis by sampling exhaled breath   "
145572|NCT01379053|"     The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus,     which may predict the probability of bacterial organisms in the anterior nares, throat and     respiratory tract, wounds, and anus and therefore be able to replace or supplement current     active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists     of:        -  A collection apparatus for collection of volatile compounds from suspected infection          sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate          sample of room air.        -  Analysis of the volatile organic compounds from suspected infection sites and room air          by short acoustic wave gas chromatography.        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order          to predict the probability of Staphylococcus aureus infection and colonization.      This study will test the hypothesis that we can identify the presence of MRSA by sampling the     head space above culture media of anterior nare samples provided by patients with MRSA.     Additionally, this study will test the hypothesis that we can identify the presence of MRSA     by sampling air exhaled through the nostrils (nasal exhalant).   "
145573|NCT01379040|"     This experiment is designed to test the effectiveness of a new electronic nose device, which     allows a non-invasive breath test for markers of lower respiratory tract infection, which may     predict the probability of bacterial organisms in the lower respiratory tract. It consists     of:        -  A breath collection apparatus for collection of volatile organic compounds in breath          onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample          of room air.        -  Analysis of the volatile organic compounds in breath and room air by short acoustic          wave/gas chromatography.        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order          to predict the probability of lower respiratory tract colonization and infection.      This study will test the hypothesis that the investigators can identify the presence of     Pseudomonas aeruginosa by sampling the head space above culture media of sputum provided by     patients with cystic fibrosis. This study will test the additional hypothesis that the     investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath     from the patient providing the sputum.   "
145574|NCT01379027|"     Evidence-based treatments (EBTs) for mental health conditions are often not available to     persons needing them in the community. Our aim is to test a novel Internet intervention that     has the promise of eventually improving the Reach and Implementation of mental health EBTs,     speeding the translation of research successes into improved community care.   "
145575|NCT01379014|"     A decision aid tool (DAT) to assist mental health service users in reaching disclosure     decisions in the context of employment was developed in a previous study (IRAS REC ref:     07/Q0706/21). The initial feasibility and acceptability was assessed in a group of 15 mental     health service users with mean decisional conflict scores reduced from 51.98 to 35.52 after     completion. 60% of participants reported that the DAT was quick to complete, 40% that it was     easy, 60% that it was relevant and 80% that they would definitely or probably use it in     making disclosure decisions. This current study (CORAL: Proof of concept RCT) aims to     determine whether a full randomised controlled trial of the DAT is justifiable and feasible,     and to optimise its design. This will consider: 1) effects of the intervention; 2) baseline     predictors of disclosure; and 3) exploration of the relationship between use of the DAT and     the rate of disclosure.      Eighty people who are on the caseload of a vocational specialist working with people with     mental illness will be included in this study. All participants will be receiving treatment     from an Improving Access to Psychological Therapies (IAPT) service or a Community Mental     Health Team (CMHT). An equal number from each group will be allocated to receive either the     DAT intervention or treatment as usual. Individuals from both groups will complete baseline     assessment and 3month followup assessments. Those allocated to the intervention will also     complete an assessment immediately following the intervention. Qualitative interviews will     also be conducted at 3 months with a maximum of 15 people from the intervention group and 6     people from the control group.   "
145578|NCT01378975|"     This open-label, single-arm, multicenter study will evaluate the efficacy and safety in     participants with metastatic melanoma who developed brain metastases. Participants may or may     not have received prior systemic treatment for metastatic melanoma [except treatment with     v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase     (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily     until disease progression, unacceptable toxicity or consent withdrawal.   "
145579|NCT01378962|"     This single-arm, open-label study will evaluate the efficacy and safety of Tarceva     (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer.     Patients will receive daily oral doses of 150 mg Tarceva. The anticipated time on study     treatment is 12 months.   "
145583|NCT01378910|"     CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with     suppressed viremia who experience antiretroviral-related toxicity. The assessment of HIV-1     tropism in proviral DNA could be helpful to inform in which of these subjects CCR5     antagonists could be efficacious.   "
145586|NCT01378871|"     This clinical trial will be a multicenter phase II fixed-dose trial in which a minimum of 10     patients with immunophenotypically confirmed ATL with at least 50% of the blasts expressing     CD25 as measured by flow cytometry at relapse, will receive Imtox-25. Patients are eligible     for repeat courses of treatment every two weeks if they do not experience a dose limiting     toxicity (DLT) as defined in Section 5.2 and do not have a HAMA/HARA level > 1 μg/ml. The     treatment will be administered in the in-patient setting. If no response is observed among     the initial 9 patients, the study would be terminated early and declared negative; if at     least one response is observed, accrual would continue to a total of 17 evaluable patients     (total study size=19 to account for 10% of the patients being unevaluable for any reason).   "
145587|NCT01378858|"     This randomized trial will evaluate whether varenicline directly observed therapy provided at     a methadone clinic is more efficacious than self-administered varenicline for promoting     smoking cessation and enhancing adherence.   "
145588|NCT01378845|"     The purpose of this study is to evaluate the prognostic influence of light rheography     measurement at the fingertips from subjects with secundary Raynaud syndrome.   "
145589|NCT01378832|"     Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.   "
145590|NCT01378819|"     The 3-midline-ports technique is a safety approach and associates lower postoperative pain,     when compared with the standard French technique.   "
145591|NCT01378806|"     Young children who are overweight or at risk for overweight are at increased risk for     becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To     date, there have been no interdisciplinary interventions that targeted predominantly ethnic     minority low-income children and parents and taught them to work together to improve     nutrition and exercise. Using a two-group, repeated measures experimental design, this     proposed study will test a 12-week intensive intervention on nutrition, exercise and coping     skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd,     3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight     status, and adiposity. The study will take this intervention to the community in which     children and parents live, working with four schools in Alamance-Burlington County, NC, and     four schools in Wilson County in the early evening. A total of 356 Black, Hispanic, and White     children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be inducted     over 3 ½ years and randomized by school to either the experimental or control group. Data     will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3     (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up). Data collected will     include scores on the Health Promoting Lifestyle Profile II in the parents; eating     self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise     self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors     in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement);     weight status in the children (BMI percentile) and parents (BMI); and adiposity in the     children and parents (waist circumference and triceps and subscapular skinfolds). Data     analysis will use general linear mixed models to test the hypotheses. Decreasing overweight     in children and parents is urgently needed, and helping children and parents to work together     to improve their nutrition and exercise patterns by making small lifestyle pattern changes     may decrease future health care costs and decrease morbidity and mortality. The knowledge to     be gained from this study may provide a foundation for extending this intervention to other     Black, Hispanic, and White children and parents in other communities to assist them to manage     their weight.   "
145592|NCT01378793|"     The purpose of this study is to examine the effect of 6-weeks of relaxation acupressure     compared to stimulating acupressure or a standard of care on sleep and daytime functioning.     Also, to evaluate the ability of teaching acupressure using web-based applications.      It is believed that self-administered relaxation acupressure will result in improvements of     sleep quality and quantity as compared to stimulating acupressure or a standard of care.   "
145639|NCT01378091|"     Primary objectives:      To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given     every three weeks and prednisone, as combination therapy to subjects with androgen     independent prostate cancer      To evaluate the safety profile of the combination of daily lenalidomide and every three week     docetaxel and prednisone when given to subjects with androgen independent prostate cancer      Secondary objective:      To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week     docetaxel and prednisone when given to subjects with androgen independent prostate cancer.   "
145593|NCT01378780|"     Stroke is a disease with tremendous individual, family, and societal impact. It is the number     one cause of adult disability and third leading cause of death in the United States. Between     now and the year 2050, the cost of stroke in the United States will exceed 2 trillion     dollars. There is a tremendous ethnic disparity with respect to stroke in the United States.     Mexican Americans are much more likely to have a stroke compared with European Americans. In     Mexican Americans strokes occur at younger ages, are more likely to recur and have the same     severity as they do in European Americans. Mexican Americans are the overwhelming largest     sub-population of Hispanic Americans, the nation's largest minority group. This proposal, a     scientifically-based rigorous behavioral education intervention trial, seeks to aggressively     prevent stroke, especially in Mexican Americans.      Faith and family are strong components of Mexican American culture. This project works with     these positive fundamental elements in order to affect stroke prevention. This project will     take place in Nueces County, Texas. The project investigators have worked in this community     for the past 14 years and have published extensively regarding the stroke health disparity in     this stable, non-immigrant community of Mexican Americans and European Americans. We have     established a strong partnership with the Catholic Diocese of Corpus Christi and assembled a     team with tremendous experience at successful health behavior intervention research.     Together, a proposal has been crafted that will directly speak to aggressive stroke risk     factor reduction in Mexican Americans and European Americans in this representative United     States community.      The significance of such research is tremendous. As the Mexican American population grows and     ages, the stroke impact will be felt with greater and greater intensity. Now is the time to     develop aggressive, scientifically tested interventions to limit the burden of this disease     on this important segment of the United States population, and to reduce the costs of this     disease to the country as a whole, in keeping with the Government Performance and Results Act     (GPRA) goal to identify culturally appropriate, effective stroke prevention programs for     nationwide implementation in minority communities by FY2010.   "
145594|NCT01378767|"     The investigators hypothesized that individuals supplementing with krill oil capsules (two     grams per day) would experience enhanced improvements in health-related variables during a     21-day Daniel Fast.   "
145595|NCT01378663|"     One of the main problems that faces children undergoing congenital cardiac surgery is     posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled     Analgesia) are the main means of pain management here at NCH. In this study, the     investigators will review the difference between different PCA and NCA modalities. Also, the     investigators aim to find out if there are differences between age groups in terms of type of     drug used, total drug used, side effects and length of use of the PCA or NCA.   "
145604|NCT01378546|"     Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle     weakness and limited reflex activity. More than half of LEMS cases are associated with a     malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not     coupled with malignant cells.      3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating     the weakness associated with LEMS as it increases strength and improves autonomic symptoms in     LEMS patients. It is not currently approved by the FDA for use in the United States. The     investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University     MDA/ALS Research Center.   "
145596|NCT01378650|"     1. Overview of tinnitus Tinnitus is a noisy sound which is perceived without any external          sound source. According to the survey of the US, 10-20% of adult have the symptom of          tinnitus and 3-5% of tinnitus patients have severe discomfort of daily life. Severe          tinnitus can result in psychiatric problems such as depression and anxiety disorders.          Enhancement of environmental sound, hearing aids, sound generators, cognitive therapy,          transcranial magnetic therapy, and drug therapy have been tried for treatment of          tinnitus. Nitric oxide(NO) is a well-known neurotransmitter acting as a vasodilator          through regulation of production of cyclic guanosine monophosphate(cGMP) and can be          found in various sites of cochlea. It is reported that cGMP enhances activity of protein          kinase A (PKA), a mediator of platelet aggregation inhibition and vasodilatation and          results in increase of vascular flow.        2. Characteristics of the clinical research drug, cilostazol Cilostazol inhibits          phosphodiesterase type 3 (PDE3) selectively and increases amount of cAMP by inhibition          of degradation of cyclic adenosine monophosphate(cAMP). cAMP again by increasing the          active form of PKA suppress the production of blood clots and increase blood flow by          expanding blood vessels. Anti-platelet activity and vasodilatation effect of cilostazol          have been used for improvement of diabetic peripheral vascular disorders and suppression          of stroke recurrence. Previous studies reported that by increasing the activity of NO          and PKA, the blood flow of stria vascularis and cochlear hair cells can be improved.          These studies implies that cilostazol, which causes inhibition of PDE3 and increase of          PKA, can have a potential effect on improvement of tinnitus by increase of blood flow to          peripheral cochlear cells. Thus, we hypothesized that cilostazol, which has been widely          used for enhancing peripheral blood flow, can bring improvement of tinnitus by causing          better peripheral blood flow of cochlea.        3. The aim of the study We planned this study to validate the assumptions of the          background. The aim of our study is whether administration of cilostazol can improve          tinnitus in terms of subjective degree of symptoms in chronic tinnitus patients.   "
145597|NCT01378637|"     The purpose of this protocol is to determine if individuals who had a stroke more than one     year before entering the study and whose ankles remain substantially impaired are able to     sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy     device (AMES).   "
145598|NCT01378624|"     Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune     cells derived from bronchoalveolar lavage after segmental allergen challenge in patients with     asthma and pilot study to assess local inflammation induced by segmental allergen challenge     by magnetic resonance imaging.   "
145599|NCT01378611|"     Clinical randomized controlled observer blinded add-on design. Additionally there will be a     non-controlled follow-up phase of the study. Children (Age 4-18 years) with intractable     epilepsy, and not eligible for resective surgery will be treated with VNS.      Aim of the study:        1. To evaluate tolerability and effectiveness of VNS in children with intractable epilepsy          and cognitive and behavioural problems in a controlled study.        2. To evaluate the effect of VNS on the immune system which, in its turn, will lead to          changes in the serotonin metabolic pathway        3. To link the therapeutic effect of VNS to changes in the serotonin (5HT) metabolic          pathway.      In addition the investigators hope to detect some markers of immune and neurotransmitter     function that enable us to predict 1) Neuronal cell loss in relation to cognitive decline 2)     the response to therapeutic treatment of VNS.      Hypothesis:      The investigators aim to explore neuronal correlates for cognitive morbidity in children with     intractable epilepsy and to relate this to morphologic changes, biochemical markers, and to     epilepsy characteristics.      Correction of the stressed pro-inflammatory status of monocytes/macrophages via an     electrical stimulation of the vagus nerve will prevent/ameliorate seizures as well as     behavioural mood symptoms in children with refractory epilepsy, characterized by the     pro-inflammatory monocyte signature   "
145600|NCT01378598|"     Research has found that patients sometimes have trouble obtaining oral (by mouth) cancer     medications, understanding how to take these pills, handling side effects related to these     drugs, and remembering to take these medications. The purpose of this research study is to     have direct care nurses (DCNs) in the Thoracic Oncology Program (TOP) clinic provide teaching     and follow-up to patients starting erlotinib (using a teaching tool) and to test the     feasibility of providing education and follow-up. This study will also evaluate if increasing     knowledge about erlotinib helps participants manage side effects and stay on their erlotinib     without interruptions.   "
145601|NCT01378585|"     The objective of this study are:        1. To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject        2. To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject   "
145640|NCT01378078|"     Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in     healthy subjects and depressed patients. In this study, patients with treatment resistant     negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI     measures will be performed.   "
145641|NCT01378065|"     This is a prospective, multi-center study designed to assess the palpability of the     Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.   "
145602|NCT01378572|"     With the present study the investigators intend to identify the morphologic and     electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated     cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of     sudden cardiac death. Moreover, the investigators also aim to identify if there is any     electrophysiological substrate modification at the time of the first arrhythmic event in     these patients. To this aim, the investigators will prospectively correlate electroanatomic     mapping and cardiac magnetic resonance findings with arrhythmic events, in order to identify     substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy, who     are therefore more likely to benefit from a defibrillator implantation. Furthermore,     electroanatomic mapping will be repeated at the time of the first arrhythmic event and     compared with that at baseline, in order to evaluate any electrophysiological substrate     changes.   "
145603|NCT01378559|"     The purpose of this study is to assess patient satisfaction with the Titan one touch release     penis prosthesis and to register complications with this prosthesis. This will regard the     first prostheses inserted at Herlev Hospital/Frederikssund Hospital.      Patient satisfaction will be assessed by mailing out the Erectile Dysfunction Inventory of     Treatment Satisfaction (EDITS) Questionnaire and recording the patient answers. The most     important question will be Overall how satisfied are you with penile prosthesis?.      Complications (including infection, bleeding, and mechanical failure) will be assessed by a     patient chart review and confirmed by a brief phone interview.   "
145605|NCT01378533|"     The purpose of this trial is to compare the 3 years DFS of dose-dense epirubicin and     cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy     for triple-negative breast cancer.      The other purpose of this trial is to observe the patient's tolerance.   "
145607|NCT01378507|"     Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of     endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The     purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.   "
145608|NCT01378494|"     Utilizing an extremely well-characterized HIV cohort under observation as ART-naïve or since     their first exposure to HIV treatment, the investigators will conduct a cross-sectional study     with prospectively collected data to determine BMD in 200 subjects. Subjects identified were     initially treatment naïve when entering the University of Alabama at Birmingham (UAB) 1917     HIV Clinic between 1999 and 2010; some have been under observation without being treated with     ART therapy and others were newly started on ART therapy while under observation. For each     subject, the investigators will determine associations between BMD and 1) cumulative viremia,     2) ART duration, and 3) ART type.      Hypothesis 1a: BMD will be lowest in HIV+ subjects with the highest levels of cumulative     viremia.      Hypothesis 1b: BMD will be greatest in HIV+ persons with longest duration of ART therapy,     after excluding those subjects treated with tenofovir.      Hypotheses 1c: BMD will be lower in subjects treated with tenofovir vs. other ART agents,     after controlling for duration of therapy.      Additionally, the investigators will conduct a retrospective study in 100 patients HIV+ and     were ART-naïve at the time of entry into the 1917 Clinic in whom the investigators will     longitudinally evaluate the relationship between HIV viral load, inflammation, and bone     turnover (through the measurement of HIV copy-years viremia, interleukin-6 {IL-6}, tumor     necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}, osteocalcin, and     urine C-telopeptide {CTX}). The investigators will compare HIV patients at a similar stage of     their disease who remain treatment naïve (either due to concerns for compliance or sufficient     CD4 counts without treatment) (ART-) vs. those newly started on ART (ART+).      Hypothesis 2: Viral load, markers of inflammation, and markers of bone resorption will all     decrease in ART+ vs. ART- persons.   "
145609|NCT01378481|"     This study is being done to determine if an investigational cancer treatment called     vorinostat combined with fractionated stereotactic radiation therapy (FSRT) is effective in     treating recurrent high grade gliomas. The main goal of this research study is to determine     the highest dose of vorinostat that can be given to patients with recurrent tumors. The study     will also determine the potential side effects and safety of these treatment combinations.     Vorinostat is a small molecule inhibitor of histone deacetylase (HDAC). HDAC inhibitors help     unravel the deoxyribonucleic acid (DNA) of the cancer cells and make them more susceptible to     the treatment with radiation.   "
145610|NCT01378468|"     Non-fasting triglyceride levels are thought to play a role in stroke. The investigators     hypothesise that the results of a standardised oral triglyceride tolerance test in the     subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of     recurrent stroke within 12 months after the index event.   "
145611|NCT01378455|"     Visual perception impairment and upper limb disability will affect the handwriting     performance. Children with cerebral palsy (CP) who have good function on upper extremity may     associated with visual perception impairment, which will impact the handwriting performance.     However, there were few studies to investigate the handwriting problems in children with CP     who have good upper limb functions. To date, there are no studies to investigate the     effectiveness of computerized handwriting training programs on handwriting performance in     children with CP. The aims of this study were to establish the relationships of visual     perception, visual motor integration, and motor coordination of handwriting performance in     children with typical development (TD) in Taiwan, to establish the norms of handwriting     performance in children with TD in Taiwan, to compare handwriting performance in children     with CP and children with TD, to clarify the relationship of visual perception function and     handwriting performance in children with CP, and to examine the effectiveness of interactive     computerized handwriting training program (ICHTP) on handwriting performance in children with     CP.      The investigators will collect 90 children with TD and 48 children with CP in the 1st phase.     All children will receive clinical and Chinese handwriting assessment tool (CHAT)     assessments. The CHAT and ICHTP will be modified as Taiwan-version handwriting assessment     tool and training programs for children in Taiwan, respectively. Clinical assessments include     the visual perception, visual motor integration, fine motor skill, and handwriting     performance. The CHAT assessed the handwriting legibility, accuracy, pen pressure and writing     speed. In the 2nd phase, the investigators will collect 48 children with CP, who were     randomly classified into ICHTP group and Traditional Handwriting Training Program (THTP). All     children with CP will receive clinical and CHAT assessments before and after interventions.      The expected results of this study are the visual perception function is related to     handwriting performance in children with CP, and the improvements in the handwriting     legibility, accuracy, pen pressure and writing speed of ICHTP training group are greater than     THTP training group.   "
145642|NCT01378052|"     Many studies previously showed the significant association between urinary arsenic profiles     and urothelial carcinoma (UC) risk and observed the increased UC risk in people with lower     plasma folate and higher homocysteine than those with higher plasma folate and lower     homocysteine. The investigators would expect to explore the interactions among global DNA     methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and UC.   "
145612|NCT01378442|"     In the first year, all subjects received clinical assessments include subjective assessment,     basic data, nutritional status and fitness assessments. Laboratory assessments include body     composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone     strength (by calcaneal ultrasound) and bone metabolism.      In the 2nd year, were randomized into three groups. The high level training group (20     children) will receive high frequency fitness training program(Frequency: three times one     week, Duration: thirty minutes). The low level training group (20 children) will receive low     frequency fitness training program(Frequency: two times one week, Duration: thirty     minutes).The control group (20 children) will not receive fitness training program but     maintain the usual life style.      In the 3rd year, all subjects received post-training clinical assessments include subjective     assessment, basic data, nutritional status and fitness assessments. Laboratory assessments     include body composition, bone density(lumbar spine and femur by dual energy X-ray     absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.      These data provided in this study could establish the bone quality and fitness data of     children with diplegic CP, and provide us to plan treatment strategies in the management of     bone and fitness problems in the future.   "
145613|NCT01378429|"     This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety     study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered     once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of     PAR.   "
145614|NCT01378416|"     The purpose of this study is to determine the pharmacokinetics (PK) of decitabine     administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).   "
145615|NCT01378403|"     Schizophrenia patients in comparing to normal controls show decreased ability to identify     objects with decreased level of fragmentation, a task that is associated with magnocellular     pathway function.   "
145616|NCT01378390|"     The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem     cells) for treatment of complex perianal fistulas in patients with Crohn's disease.   "
145617|NCT01378377|"     The research trial is testing the experimental drug MSC1936369B (Pimasertib) and the drug     TORISEL, given together, in the treatment of advanced solid tumors. The primary purpose of     the study is to determine the maximum tolerated dose and the recommended Phase II dose (RP2D)     of the drug combination.   "
145618|NCT01378364|"     The aim of the study is to investigate safety, tolerability and pharmacokinetics of single     rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to     healthy male volunteers.   "
145619|NCT01378351|"     The purpose of this study is to characterize the accompanying symptoms, evaluation and     management of patients with chronic vestibular dysfunction presenting with nausea and     vomiting.   "
145620|NCT01378338|"     Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD     in Korea-an observational study.   "
145621|NCT01378325|"     Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload)     to be more effective in terms of managing hypotension as compared to administering     crystalloid before spinal anesthesia (preload).      Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of     hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of     high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid     coload up to two liters (administration at the time of SA). However, incidence of reactive     hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise     concern in patients in whom increase of blood pressure may be detrimental, like chronic     hypertension and in the presence of a compromised uteroplacental blood flow. A recent study     found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with     more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min     respectively. However, there was no reduction in the number of physician interventions     (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood     pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have     limited application in clinical practice, and a variable rate (i.e. modifying the rate     according to hemodynamics) has been advocated. The bolus administration of phenylephrine to     treat hypotension is still commonly used, but requests multiple interventions from the     anesthesiologists and is time consuming.      Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to     one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated     Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will     receive infusion of normal saline (placebo) and patients in group II variable infusion rate     of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed     infusion rate). The number of interventions needed to maintain maternal systolic blood     pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting,     and umbilical cord blood gases will be compared between the two groups.      We will define a reliable and safe method to ensure maternal hemodynamic stability during     spinal anesthesia for cesarean delivery with the least physician interference.   "
145622|NCT01378312|"     This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study     in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of     tuberculosis infection. The study will be conducted at one clinical research site in India.      The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete     protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or     booster, while not toxic, does not provide much additional protection. AERAS-402 presents     tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine     that may increase T cell-mediated immunity and thus protection from tuberculosis. Since     BCG-vaccinated individuals are the population for which AERAS-402 might be indicated,     AERAS-402 will be administered to individuals already vaccinated with BCG.   "
145623|NCT01378299|"     Testosterone (T) replacement prevents bone loss and relieves symptoms associated with     androgen deficiency in male patients with hypogonadism, but at the expense of an increase in     prostate-related adverse events and in the hematocrit values above the normal which may lead     to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by     its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the aromatase     (CYP19A1) gene result in enzymes with variable activity and variable levels of E2 and T. This     project is designed to determine if genetic variations in the CYP19A1 gene will result in     differences in the skeletal response and incidence of side effects from T treatment in     patients with low T. A large number of male Veterans are on T. Results from this project will     help identify patients who would benefit from the therapy from those at risk for side     effects, and would definitely have an impact in the future care of these patients and male     patients in general once genetic profiling becomes part of the standard of care.   "
145655|NCT01377883|"     Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin     (BTX) injections that are administered several times a year. While clown care reduces     preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized     that medical clowning reduces pain and anxiety during BTX injections.   "
145624|NCT01378286|"     Primary Objective:      - To demonstrate the non-inferiority of corrected adequate clinical and parasitological     response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine      Secondary Objectives:        -  To assess the non inferiority on the same way as the main criteria:        -  at Day 28 before corrected cure rate        -  at Day 14 and Day 42 before and after corrected cure rate        -  To compare the two groups of treatment in terms of:        -  Efficacy:             -  Proportion of aparasitaemic patients at 24, 48 an 72 hours             -  Proportion of afebrile patients at 24, 48 and 72 hours             -  Percentage of gametocyte carriers during follow-up             -  Evolution of the mean of gametocytes during the 42 days of follow-up             -  Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28        -  Clinical and biological tolerability:             -  Proportion of any adverse event             -  Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells,               neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino               transferase/ALT), bilirubins)             -  ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old               and above   "
145625|NCT01378273|"     Recombinant human erythropoietin (Epo) is a promising novel neuroprotective agent. Epo     decreases neuronal programmed cell death resulting from brain injury; it has     anti-inflammatory effects, increases neurogenesis, and protects oligodendrocytes from injury.      We hypothesize that neonatal Epo treatment of ELGANs will decrease the combined outcome of     death or severe NDI from 40% to 30% (primary outcome), or the combined outcome of death plus     moderate or severe NDI from 60% to 40% (secondary outcome) measured at 24-26 months corrected     age.        1. To determine whether Epo decreases the combined outcome of death or NDI at 24-26 months          corrected age. NDI is defined as the presence of any one of the following: CP, Bayley          Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Scale < 70          (severe, 2 SD below mean) or 85 (moderate, 1 SD below mean). CP will be diagnosed and          classified by standardized neurologic exam, with severity classified by Gross Motor          Function Classification System (GMFCS).        2. To determine whether there are risks to Epo administration in ELGANs by examining, in a          blinded manner, Epo-related safety measures comparing infants receiving Epo with those          given placebo.        3. To test whether Epo treatment decreases serial measures of circulating inflammatory          mediators, and biomarkers of brain injury.        4. To compare brain structure (as measured by MRI) in Epo treatment and control groups at          36 weeks PMA. MRI assessments will include documentation of intraventricular hemorrhage          (IVH), white matter injury (WMI) and hydrocephalus (HC), volume of total and deep gray          matter, white matter and cerebellum, brain gyrification, and tract-based spatial          statistics (TBSS based on diffusion tensor imaging). As an exploratory aim, we will          determine which of the above MRI measurements best predict neurodevelopment (CP,          cognitive and motor scales) at 24-26 months corrected age.      Anticipated outcomes: Early Epo treatment of ELGANs will decrease biochemical and MRI markers     of brain injury, will be safe, and will confer improved neurodevelopmental outcome at 24-26     months corrected age compared to placebo, and will provide a much-needed therapy for this     group of vulnerable infants.   "
145678|NCT01377558|"     The purposes of the study are        -  to determine which kind of supervised exercise intervention (aerobic endurance training          versus strength endurance training versus combined aerobic endurance and strength          endurance training) is more effective in improving the metabolic parameters in typ 2          diabetes patients        -  to investigate what kind of intervention is more successful in reduction of concomitant          diseases and improving quality of life        -  to assess what kind of intervention induces highest effects in long term persistence of          these positive changes   "
145626|NCT01378260|"     The specific aim of this study is to prospectively compare outcomes (functional, quality of     life, risk-adjusted clinical event) of medical management, surgical or endovascular     (angioplasty or stent placement) interventions for the treatment of claudication caused by     peripheral arterial disease. This study will test two major hypotheses;      Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements     in function, claudication symptoms, and health-related quality of life (HRQoL) than     endovascular procedures or medical management.      Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with     greater improvements in function, claudication symptoms, and HRQoL than medical management.   "
145627|NCT01378247|"     The purpose of this study is to determine whether Family Focused Nursing are effective in the     treatment of heart failure outpatients with respect to health-related quality of life.   "
145628|NCT01378234|"     The Enhanced Discharge Planning Program (EDPP) is an intervention designed to help older     adults safely transition to the community after discharge. This is achieved through     telephonic care coordination facilitated by social workers. EDPP social workers ensure full     implementation of the discharge plan, assist with coordinating community resources and     follow-up appointments, and intervene around other issues that may arise as a result of a     complex transition.      The EDPP intervention is currently being offered to some older adult patients discharged from     Rush University Medical Center. Case managers refer older adult patients on selected units     who they believe may be at risk for adverse events post-discharge. While this service is     being provided to patients, it has not yet been formally evaluated. This randomized     controlled trial will provide data necessary for a more rigorous evaluation of the efficacy     of this intervention.   "
145629|NCT01378221|"     Advanced age is associated with an increase in postoperative morbidity and mortality in     cardiac surgery patients. In detail, compared with younger patients those aged 75 years and     older have significantly higher rates of in-hospital mortality, cerebrovascular events,     pneumonia, and dialysis. In addition, older cardiac surgery patients have longer mechanical     ventilation times. Vitamin D exerts several beneficial effects on the cardiovascular system.     Moreover, it has immuno-modulatory and anti-inflammatory properties. The hormonal form of     vitamin D, 1,25-dihydroxyvitamin D, is an independent predictor of mid-term mortality in     cardiac transplant recipients. 1,25-dihydroxyvitamin D also predicts mid-term and long-term     mortality in patients with a high risk for cardiovascular disease. Mild renal impairment,     insufficient vitamin D levels, and secondary hyperparathyroidism are common in frail elderly     individuals. The present study aimed to investigate whether cardiac surgery exerts     age-dependent effects on calciotropic hormones, components of the immune system, and     inflammatory processes.It is hypothesized that (i) baseline 1,25-dihydroxyvitamin D levels     are lower in patients <= 75 years of age compared to younger patients, (ii) cardiac surgery     results in a transient decrease in circulating 1,25-dihydroxyvitamin D, and (iii) that the     decrease in 1,25-dihydroxyvitamin D is probably more pronounced in older than in younger     cardiac surgery patients.   "
145643|NCT01378039|"     Asthma and chronic obstructive pulmonary disease(COPD) are common diseases, which tend to     even increase in many countries. Both from a clinical and a pathophysiological point of view,     this is an important issue. However, an understanding of the relationship between the complex     array of cells and mediators involved in asthma and COPD is not yet fully dissected which     makes difficult to find a specific and sensitive panel of biomarkers that can reflect     intensity of these pathological processes and can help to predict the individual outcome.   "
145684|NCT01377480|"     This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of     asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg     twice daily improves therapeutic response compared to placebo in participants with a     diagnosis of asymptomatic chronic Chagas disease.   "
145630|NCT01378208|"     The Danish Food Administration recommends eating three main meals and three small meals a day     in order to maintain a healthy lifestyle. However, there is little research to support this     concept- moreover, many studies shows that fasting can have a positive impact on our health.      HYPOTHESIS AND PURPOSE The investigators hypothesize, that the number of meals per day in     order to maintain a healthy lifestyle will not differ in normal weight subjects.      The investigators will include 1) healthy, normal weight subjects. The investigators will     study the effects of two daily meals.      More specifically, the investigators want to better understand how the body reacts to     long-term, intermittent fasting (14 h /day for 4 weeks). The investigators will assess     cognitive function, dietary intake, appetite regulation, fitness, glucose and insulin     responses, as well as fat and muscle composition of the body before, during, and after the     study.      Our long-term goals are to compare the effects of intermittent fasting with acute fasting.     All of this is in an effort to establish how our eating habits ultimately affect our health     and to, perhaps, contribute to new recommendations for healthy eating in normal weight     population.      BACKGROUND Obesity and diabetes are increasing health threats facing the Western world today,     despite abundant research efforts and campaigns to prevent such outcomes. Throughout the     years, as the incidence of both obesity and diabetes in the general population has increased,     so too has the typical number of daily meals. A once common three meals per day has now     increased to six meals per day, in many instances. Recent animal research has shown that     intermittent fasting (one or two meals per day) over a long period of time can improve     cardiovascular health and prevent chronic diseases. Biochemically, fasting leads to an     activation of metabolic mechanisms designed to preserve carbohydrates and increase the     dependence on energy produced by the metabolism of fat. There is little scientific evidence     regarding the number of meals per day that proves to be the healthiest, and those studies     that do exist have opposing conclusions. Several theories do exist regarding the number of     meals per day that affect us in the most favorable way, but these are just theories. Our     study is the first to assess, in both a systematic and controlled setting, how long-term,     intermittent fasting affects the human body.   "
145631|NCT01378195|"     Photozig and Stanford University are creating a program to help cope with caregiving,     alleviate related stress, and enhance quality of life for caregivers, with funding from the     National Institute on Aging. This home-based program includes a free DVD, printed materials,     and resource website. In addition, after completing the program, participants will have free     access to final online resources for 1 year. There are no face-to-face meetings, and     participants can live anywhere in the United States.   "
145632|NCT01378182|"     Wilson's disease is an autosomal recessive genetically inherited disorder of copper     metabolism, causing neurological, psychiatric and liver disease. The ATP7B gene on the 13th     chromosome is responsible for the disease. Liver has a critical role on copper metabolism. It     is the main site of copper accumulation and bile secretion is the only physiologic way of     copper elimination. Due to defective production of ceruloplasmin which carries copper, wide     amount of free copper precipitates throughout the body but particularly in the liver, eyes     and brain. Patients are bound to lifelong chelating agents such as penicillamine, trientine     and tetramine dihydrochloride. Unfortunately, these medications may cause severe side-effects     such as hypersensitivity reactions, bone marrow suppression, auto-immune disease and     sideroblastic anemia. Medical treatment of liver cirrhosis, the last stage of the illness     that leads to morbidity and mortality in the Wilson Disease, is difficult. Liver     transplantation is still the most effective treatment for the patients with liver cirrhosis     in Wilson Disease. However, serious problems are accompanied with liver transplantation. Lack     of liver donors, complications during and after the surgery, graft rejection and high costs     are the main problems.      There are cells in the human body that are capable to renew themselves and differentiate to a     diverse range of specialized cell types. These are called stem cells. Stem cells can be     differentiated to specialized cells in appropriate medias in the laboratory. Recently, the     differentiation potential of mesenchymal stem cells into hepatocytes is proved by     demonstrating hepatocytes containing Y chromosome in the female who has had bone marrow     transplantation from male donors. In many laboratory studies, it is observed that human bone     marrow derived mesenchymal stem cells, transplanted to animals with induced liver damage,     differentiate into the albumin producing hepatocytes without fusion. By these studies, it is     understood that mesenchymal stem cells are more potent than other bone marrow elements in     context of differentiation to hepatocytes. Even though the number of studies on human for the     same purpose is few, findings are supporting those of animal experiments. Mesenchymal stem     cells are non-immunogenic. Safety and feasibility of allogeneic transplantations between     individuals without need of immunosuppressive drug regimen are proven. Proofs of correcting     metabolic defects by this way are also presented in some publications. For the reasons     mentioned above, allogeneic mesenchymal stem cell transplantation is a promising treatment     modality especially for the hereditary metabolic diseases. By this way, non-immunogeneic     mesenchymal stem cells which have healthy genetic structure, can manufacture the required     enzyme, will be repopulated in the damaged tissue and contribute to the clinical improvement.      In this study, mesenchymal stem cells will be derived from healthy volunteer donor's bone     marrow and be expanded in-vitro, and then 1 million cells per kg will be infused to patients     with liver cirrhosis related to Wilson disease, 50 million cells via hepatic artery and the     remaining cells via peripheral vein. It is aimed to enable liver regeneration, decrease     fibrosis rate, improve patient's health conditions, increase ceruloplasmin synthesis,     ameliorate disorder of copper metabolism, decrease the need for chelating agents, increase     living standards of patients, and prolong waiting time for liver transplantation. Finally it     is aimed to establish a new and regenerative treatment protocol alternative to liver     transplantation. For observation of clinical and laboratory improvement, patients are planned     to be monitored by histopathologic examination of liver biopsies before and at 6th month     after the treatment, monthly biochemical and hematologic blood tests and periodic radiologic     examinations. This is a hopeful, avant garde and sophisticated study which may constitute new     horizons in context of cellular therapies.   "
145668|NCT01377688|"     We propose to pilot a telehealth approach to evaluate components of risk communication by:        1. Providing personalized tailored patient feedback to help initiate and maintain specific          diabetic kidney disease (DKD)-related behaviors (e.g., medication adherence, weight,          exercise, diet, smoking cessation) to reduce their risks.        2. Evaluating how this feedback can be incorporated into clinical care by examining 6 month          patient outcomes.      Specific Aims are:        1. To evaluate the feasibility and acceptability of providing both patients and their          provider feedback on individuals' DKD risk via the telehealth intervention and          incorporating it into regular clinical practice.        2. If improvements in outcomes are found, to estimate the cost of the program in terms of          the patient, provider, and overall costs of implementing the program.   "
145633|NCT01378169|"     Aim of the study : The primary aim of the investigators study is to highlight the presence of     biomarkers (biological indicators of the presence of inflammation or infection) of infectious     processes during the systemic inflammatory response (SIRS) allowing, first to discriminate     non-infectious inflammation from infectious processes and secondary to determine the     microbial pathogen responsive of the infection. For this purpose the investigators will     conduct a combinatorial approach of several blood markers including usual markers of     inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA)     known to inhibit determined gene expression, will also be analysed in monocytes (a specific     group of white blood cells involved in the fist line of defences against microbes.      Study design : For this purpose the investigators will include 300 patients admitted to the     intensive care unit with suspicion of infection. Serial blood sample will be take for     biological parameters analysis. Efficiency of each single parameters and of different     combinations of different markers to determine the presence or absence of infection     responsive of clinical inflammation will be studied.   "
145634|NCT01378156|"     GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia     who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test.     This study has 3 phases. The first phase is the vaccination phase, where patients are     vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second     phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12     week period approximately 8 weeks following the last vaccination. The third phase occurs     after the 12 week treatment interruption phase and is called the treatment reinstitution     phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The     primary objective is to evaluate the safety of the vaccines during the three phases of the     study. A secondary objective is to evaluate the immunogenicity of the vaccines during the     vaccination phase of the study.   "
145635|NCT01378143|"     The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS     in combination with standard of care as a second line treatment in subjects with unresectable     and locally recurrent or metastatic colorectal cancer.   "
145636|NCT01378130|"     Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore     further investigations are needed. During this study patients with an acute episode of     central serous chorioretinopathy are observed with established ophthalmologic methods     (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further     insides in etiology, course and prognosis of this disease.   "
145637|NCT01378117|"     High blood glucose levels in hospitalized patients with diabetes are associated with     increased risk of medical complications and death. Improved glucose control with insulin     injections may improve clinical outcome and prevent some of the hospital complications.     Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the     hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose, but has not been     tested in the hospital. It is not known if sitagliptin is as effective in controlling blood     sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine)     injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar     in hospitalized patients with diabetes.      In this pilot study, patients with known history of diabetes treated with diet and/or OAD or     with low total daily dose insulin therapy (<0.4 unit/kg/day) will be randomized to receive     sitagliptin once daily (group 1), sitagliptin plus basal (glargine) insulin once daily (group     2), or basal bolus regimen with glargine once daily and lispro insulin before meals (group     3). If needed, patients in the 3 treatment groups will receive correction doses of     rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia (BG > 140 mg/dl) per     sliding scale. The overall hypothesis is that treatment with sitagliptin once daily alone or     in combination with basal insulin in patients with type 2 diabetes will result in a similar     improvement in glycemic control and in a lower frequency of hypoglycemic events than     treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before     meals.      A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will be     recruited at Grady Memorial Hospital and Emory University Hospital.   "
145638|NCT01378104|"     1. Randomized controlled multicenter study        2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis          C genotype 1        3. IL28B polymorphism in Koreans with CHC   "
145644|NCT01378026|"     G72 gene is located on the common linkage locus in bipolar disorder and schizophrenia, and it     encodes D-amino acid oxidase activator (DAOA). There are evidences that elucidated G72 and     D-amino acid oxidase(DAO) together playing a critical role in the pathophysiology of     schizophrenia. Recently, reports discovered missense mutations in the DAO (R199W DAO and R38H     DAO) are associated with familial amyotrophic lateral sclerosis (FALS), and our preliminary     data showed that the level of G72 autoantibody decreases in patients with ALS compared with     normal control. Thus, we want to find out whether G72 plays a role in ALS and     neurodegenerative diseases including Alzheimer disease and Parkinson's disease. First, we     detect G72 protein and its autoantibody in sera of neurodegenerative diseases patients using     ELISA and Western blotting, and the data are compared with normal control. We hypothesize the     levels of G72 protein and its autoantibody in neurodegenerative diseases are less than those     in normal control. Then, we extract genomic DNA of neurodegenerative diseases patients, and     use polymerase chain reaction(PCR) to detect single nucleotide polymorphism (SNP) of G72. We     aim to detect G72 missense SNP variants presented in ALS, AD and PD.   "
145669|NCT01377675|"     This study involves the development and evaluation of a web-based, interactive education     program on chronic obstructive pulmonary disease (COPD) for primary care clinicians.      The research questions that this proposal addresses include:        1. Can an interactive, web-based COPD course be developed to disseminate evidence-based,          best practice recommendations to primary care clinicians?        2. Can assessment tools be developed to evaluate the impact of the program on clinician          behavior in clinical practice and on patient care?   "
145679|NCT01377545|"     The investigators propose to test the hypothesis that when placing a perineural catheter for     a continuous peripheral nerve block, injecting the initial local anesthetic bolus via the     insertion needle results in a faster-onset sensory block than injecting the initial bolus via     the perineural catheter. The study results will help define the optimal local anesthetic     bolus introduction technique—needle versus catheter—for peripheral nerve blocks when placing     a perineural catheter.   "
145645|NCT01378013|"     This work will use a new approach to measure how surgery effects human biochemistry and     metabolism. It will create a metabolic signature or 'phenotype' for surgical injury that will     help clinicians choose the right surgical treatments for an individual. This is because     metabolism is based on an individual's genes, disease burden and environmental influences     such as gut microbiota. This study will use a scientific method based on computational     analysis of spectra taken from techniques known as Mass Spectrometry (MS) and Nuclear     Magnetic Resonance (NMR) spectroscopy. This science is called 'metabonomics' and it has many     advantages. Firstly, it provides a measure of thousands of metabolites at a single moment in     time that are unique to the individual and it therefore gives a 'systems' overview of a     persons metabolism. Secondly it is able to process many hundreds of samples quickly. The     investigators are aiming to integrate the investigators metabolic data with genetic     information about patients or bacteria wherever possible. This will be the first time that a     'systems biology' approach has been used in surgery, with potentially significant gains to me     made in pre operative risk stratification and optimisation. By performing this analysis at     all stages of the surgical journey (preoperatively, during the operation and after the     surgery) it will ensure the right treatments are given to the right patient at the right     time. By creating longitudinal models of the biochemical responses to surgery, predict at a     much earlier stage those patients at risk of developing complications. This will improve     outcome after surgery. This work will use a metabonomic approach to create new tools for     surgeons to use during operations based on tissue biology. For example the investigators will     be able to measure the metabolic content of tumours in real time by measuring the biological     content of diathermy smoke. This has the potential to change intra-operative decision making     and further improve outcome.   "
145646|NCT01378000|"     A clinical trial to study the effects of dosage, infusion methods and complications of     unfractionated heparin (UFH) treating acute progressive cerebral infraction was conducted. In     this study, we observed the effects of four UFH treatments on 480 acute progressive cerebral     infraction patients during from the 6th and the 72nd hour after the attack. It was concluded     that the ultra-slow continuous intravenous infusion of UFH can significantly reduce the     neurological deficit score of patients with progressive cerebral infarction, increase the     cure rate, decrease the recurrence rate, and improve long-term quality of daily life. It is     more effective than the treatment of intravenous infusion of low- molecular- weight UFH at     once a day, and the risk of bleeding may not necessarily be increased.   "
145647|NCT01377987|"     The ultimate goal is to improve our understanding of the pathophysiology and resistance to     effective treatment of sleep disordered breathing in patients with heart failure, with a     focus on selecting patients that will benefit specifically from acetazolamide treatment.      The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the     apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients     with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the     most severe ventilatory control instability (strongest chemoreflex response to carbon     dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory     control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary     congestion, and cardiac function.   "
145648|NCT01377974|"     The purpose of this study is to determine whether miltefosine is effective in the treatment     of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.   "
145649|NCT01377961|"     Type 2 diabetes mellitus (DM2) is a growing social health problem world-wide, in particular     with respect to its contribution to cardiovascular disease. The progressive increase in     prevalence of DM2 has reached epidemic proportion and is a major cause of morbidity and     mortality in all populations around the world. Conventional stepwise treatment of DM2     generally focuses on controlling blood glucose concentration. However, the risk for     side-effects associated with the use of pharmacological intervention often delays initiation     of therapy, with the potential implication on worsening morbidity and mortality from     complications. On the other hand, non-pharmacological intervention in the form of dietary     restrictions, exercise and weight loss, is safe but often difficult to accomplish. The     availability of nutrients that affect glucose and lipid metabolism would provide an important     practical tool to establish early intervention in newly diagnosed DM2 and perhaps even in     patients who are only at risk for DM2. The investigators have recently obtained preliminary     data on beneficial effects of combined supplementation of lycopene and isoflavones on glucose     metabolism of normoglycemic volunteers with insulin resistance. This clinical trial will     explore the role of isoflavones and lycopene dietary supplementation in the improvement of     glucose metabolism of patients at increased risk or with established but mild DM2. The     overall hypothesis is that supplementation of laflavon, provided as a new formulation that     increases bioavailability of the individual components (Laflavon CamMedica contains 7 mg of     Lycopene and 50 mg of Soy Isoflavones), determines improvement in glucose tolerance and     insulin resistance of patients with the metabolic syndrome and also reduces HbA1c in patients     with mild DM2.   "
145650|NCT01377948|"     The purpose of this study is to determine whether Anger Control Therapy (ACT) with Regulate     and Gain Emotional-Control (RAGE-Control) is a feasible behavioral therapy to provide on a     pediatric inpatient psychiatric unit.   "
145651|NCT01377935|"     The purpose of this study is to compare the incidence of hospitalization for acute kidney     injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those     who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl     peptidase IV (DPP4) inhibitors.   "
145652|NCT01377922|"     A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients     with Lambert-Eaton Myasthenic Syndrome (LEMS).   "
145665|NCT01377753|"     Background:      - One way to treat prostate cancer is to use a laser to direct extreme heat to a small area     of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors     want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI     will be used to help locate tumor cells and guide the laser during surgery. However,     MRI-guided laser therapy has not been used to treat many people with prostate cancer. More     studies are needed to see whether it can destroy tumor cells permanently.      Objectives:      - To test the safety and effectiveness of treating prostate tumors with laser therapy guided     by magnetic resonance imaging.      Eligibility:      - Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has     not spread to other parts of the body.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood tests and imaging studies, and will complete questionnaires about their          health.        -  Participants will have the MRI-guided laser treatment in the hospital. The doctor will          use the MRI to control how much energy is delivered by the laser and how much tissue is          destroyed. The entire procedure usually takes from 1.5 to 3 hours.        -  After the treatment, participants will have a catheter put in to keep the bladder          emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and          bladder spasms will be given. Participants will leave the hospital once they are well          enough to go home.        -  Participants will have followup visits 3, 6, 9, 12, 18, 24, and 36 months after the          therapy. They will have physical exams, and blood and urine tests. They will also answer          questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the          therapy. They will have a prostate biopsy to see if there is any tumor every 12 months          for the first 2 years. Another biopsy may be done in the third year.   "
145666|NCT01377740|"     This study is being performed to reduce unwanted abdominal fat using two different     applicators for the Zeltiq System.   "
145656|NCT01377870|"     Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which     affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter     problems. The disease is caused by an autoimmune mechanism, ie the immune system produces     antibodies and cells which attack the self myelin antigens, causing therefore demyelination.     The disease is clinically evident with relapses of neurological disability due to the     dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs.     Disability can accumulate with time and the disease enters a progressive phase due to damage     of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist     which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of     MS (like Copaxone and interferons), there is no effective means today to stop the progression     of disability and induce rebuilding of the destroyed myelin.Adult bone marrow derived stromal     cells (MSC) were shown to induce similar (to the neuronal stem cells) immunomodulatory and     neuroregenerative effects and were shown in our laboratory to induce neuroprotection in the     animal model of chronic experimental autoimmune encephalomyelitis (EAE). These bone marrow     derived MSCs offer practical advantages for clinical therapeutic applications, since they can     be obtained from the adult bone marrow and therefore the patient can be the donor for     himself, without any danger for rejection of the cells. In addition, MSCs carry a safer     profile and are less prone to malignant transformation.      Our center will perform a clinical trial with intra venous transplantation of bone marrow     derived mesenchymal stem cell.our purpose is to evaluate the safety and feasibility of cell     transplantation after 1year following up.   "
145657|NCT01377857|"     Over twenty percent of HIV-positive persons in the United States are unaware of their     infection, leading the Institute of Medicine to recently urge further work to compare the     effectiveness of HIV screening strategies. This study will use a randomized trial to compare     several variants of emergency-room-based HIV-testing policies in order to determine how HIV     test acceptance rates can be increased. The testing policies will be designed using     principles from behavioral economics, varying the choice architecture and offering small     monetary incentives. This will be the first study to measure differences in take-up rates     across a variety of promising but largely untested approaches within a unified randomized     trial. Three defaults will be tested: traditional opt-in (test only those patients who     request testing), opt-out (routinely testing unless patients decline), and active-choice     testing (patients are required to state whether they want to be tested). The study will also     be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up.     An additional novel study contribution will be to test the hypothesis that compliance with     large requests (accept an HIV test) increases after making a small request or pre-commitment     - this foot in the door technique has not been previously studied in this setting. The     factorial design will permit a direct comparison of all interventions, as well as     interactions. The study will contribute a nuanced empirical understanding of how testing     protocols from behavioral economics theory affect the effectiveness and efficiency of     screening programs in an actual scaled- up setting (San Francisco General Hospital). This     will assist in implementing and assessing recent CDC guidelines on HIV screening, while also     more generally advancing scientific knowledge related to applying behavioral economics in     comparative effectiveness research.   "
145658|NCT01377844|"     The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated     Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels     at 24th week from baseline, when compared to placebo group(no diabetic medication given). The     secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting     blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study     assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American     Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with     placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures,     body weight and compare with the respective placebo groups.This study also assess the change     from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of     EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).   "
145659|NCT01377831|"     To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer   "
145660|NCT01377818|"     Objective: To analyze the additional benefits of exercise training application by the     non-invasive home mechanical ventilation in patients with stable COPD and hypercapnic     respiratory failure. SUBJECT: moderate-severe COPD (FEV1 <60%) in chronic respiratory failure     (hypoxemia and hypercapnia PaCO2> 45mmHg). GROUPS: 45 patients included prospectively and     randomly into 3 groups of 15: a) training + NIPPV group, b) Group training, c) Group NIPPV.     Hypothesis: A training program to the effort associated with treatment with NIPPV     significantly increase the effects compared with each treatment. MAIN OBJETIVE: Effects on     exercise capacity as measured by the test of endurance cycling and test 6-minute walk     (distance). SECONDARY OBJECTIVES: Impact on quality of life and dyspnea, as measured by     questionnaire and CRQ, systemic inflammatory response (CRP, IL-8, TNF-α), changes in     peripheral muscle strength (1RM test, isometric) and effects score BODE index.   "
145661|NCT01377805|"     Multiple sclerosis patients commonly develop generalized ventricular dilation with or without     cerebral atrophy over time. Case studies in the literature have noted some multiple sclerosis     patients develop the typical normal pressure hydrocephalus triad of dementia, gait     disturbance and incontinence which were responsive to shunts.      Many patients with connective tissue disorders (Ehlers-Danlos Syndrome) develop Multiple     Sclerosis and studies indicate that in the Multiple Sclerosis population, there exists over     10% more Ehlers-Danlos patients than in the normal population.      Because studies are indicating a form of external communicating hydrocephalus in the     Ehlers-Danlos population, the author hypothesizes the same type of hydrocephalus may occur in     the Multiple Sclerosis population.      To evaluate this hypothesis, investigators will retroactively evaluate the head circumference     of Multiple Sclerosis patients between birth and 15 months (before the skull sutures have     closed).   "
145662|NCT01377792|"     A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open     and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The     purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10     ml) increases the free time without pulmonary exacerbation, and if this increase is superior     to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.   "
145663|NCT01377779|"     This is a prospective single blind randomized controlled pilot study was designed to     investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of     intrauterine adhesions following hysteroscopic treatment for retained products of conception.   "
145664|NCT01377766|"     The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine     whether psychological factors are the potential risk factors for the occurrence of BP.   "
145670|NCT01377662|"     The main purpose of this study is to determine the outcome of a drug combination treatment on     detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The     combination regimen consists of oral administration of a generic immediate-release     methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release     formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools     and functional magnetic resonance imaging (fMRI) will be used to assess the treatment     outcome. In addition to the treatment outcome measures, we will determine whether the 14-day,     once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic     (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and     drug-drug interactions between the two drugs.   "
145671|NCT01377649|"     Contrast ultrasound is a technique that can quantify blood flow in the tissues of the body by     ultrasound detection of microbubble contrast agents that behave in the circulation similar to     red blood cells. In this study, the investigators hypothesize that contrast ultrasound of     blood flow in the leg (thigh and calf) at rest and during stress produced by medications that     mimic exercise (vasodilator stress) can provide information on the location and severity of     peripheral vascular disease (blockages of the blood vessels in the leg). The investigators     will also determine whether symptom improvement after revascularization (procedures to open     up or bypass the blockages) is directly related to the improvement in blood flow.   "
145672|NCT01377636|"     Isoproterenol is used as a cardiac stimulant in electrophysiology studies (EP). Preliminary     data suggests that administration of isoproterenol increases the Bispectral index (BIS). BIS     is used to monitor neuronal signals under anesthesia. The BIS level is suggested to     correspond to the level of consciousness. We hypothesize that isoproterenol increases BIS     values because it increases the patient's level of consciousness through its central nervous     system (CNS) stimulatory effects. In this study, we will administer increasing doses of     isoproterenol to EPS patients. We will measure the BIS levels continuously before and after     isoproterenol administration. In addition, we will test the level of awareness of patients by     their response to a modified isolated forearm technique.   "
145673|NCT01377623|"     The aim of the proposed study is to examine the effect of DEX on the inflammatory response in     major surgery. More importantly, the investigators will correlate changes in the     concentration of inflammatory mediators with meaningful clinical outcomes.   "
145685|NCT01377467|"     The primary objective of the study is to examine the effect of denosumab on lumbar spine bone     mineral density (BMD) after one year of treatment in newly transplanted renal allograft     recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck,     changes in body height, changes in bone mineral metabolism parameters, incidence of     fractures, and allograft function at one year. Safety measurements include the occurrence of     rejection episodes, infectious complications, graft loss and mortality.        -  Trial with medicinal product   "
145686|NCT01377454|"     The purpose of this pilot project is to determine whether using one inertial sensor on the     waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS)),     will be a more immediate, objective, reliable and sensitive way to measure and quantify     balance deficits in individuals with mild Traumatic Brain Injury (mTBI).   "
145713|NCT01377090|"     The CAP study is a multicenter, observational, clinical study in patients with systemic     sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and     patient-specific disease-related factors in predicting the occurrence of digital ulcers     within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis     (limited or diffuse), with or without history of digital ulceration are eligible. The study     will enroll 500 patients at 70 centers.   "
145674|NCT01377610|"     The investigators will randomize 210 opioid-dependent participants to one of two outpatient     detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper     from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single     administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day     15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient     naltrexone induction procedure, consisting of a single day of buprenorphine followed by a     washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of     injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy     for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term     outcome of the initial treatment. The primary outcome will be percentage of patients in each     group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence     at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day     detoxification, and percentage of patients in each group who return for additional Vivitrol     injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop     an improved outpatient opioid detoxification strategy, with particular relevance to newly     diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist     maintenance.      Specific Aim #1: To develop procedures for outpatient opioid detoxification which include     naltrexone to facilitate detoxification.      Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and     buprenorphine groups following short-term outpatient opioid detoxification approach for     initiating treatment for opioid dependence.   "
145675|NCT01377597|"     The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly     intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment     due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the     applicability of the phase III study results of BRAVO and CRUISE in this indication, in the     Japanese ethnic patients.   "
145676|NCT01377584|"     The purpose of this research study is to examine the effect of a couple-oriented education     and support intervention on patient- and partner -reported outcomes (positive airway pressure     (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).   "
145677|NCT01377571|"     The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced     by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in     Vietnam. In addition, we evaluate different dosages and schedules to determine the best     regimen to test in a clinical trial.   "
145680|NCT01377532|"     This is a compassionate use protocol to allow palliative therapy for patients with malignant     pheochromocytoma and paragangliomas.   "
145681|NCT01377519|"     This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved     treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis     is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham     MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic     uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1     ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants     will remain blinded to their group assignment for 3 months. After 3 months, participants will     be told their treatment group and those assigned to the sham group will be offered     complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate     candidates for a 3 month delay in fibroid treatment, such as those with significant anemia.     The investigators will assess the change from baseline to 1 and 3 months after treatment in     fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.   "
145682|NCT01377506|"     Obesity is a major public health problem among older adults, with 31% of     non-institutionalized older persons (60 years+) in the US obese and projections indicating     that this will rise to 40% by 2010. A second public health challenge on the horizon for the     aging US population is the increasing number of individuals experiencing cognitive decline,     dementia or Alzheimer 's disease. Recent clinical trials have demonstrated efficacy in     reducing risks associated with both of these significant and increasingly pervasive health     problems, which are more common among rural, low income and ethnic minority populations. The     Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in     a large, diverse population of high-risk individuals and dramatically reduced rates of type 2     diabetes onset, particularly among older adults. SeniorWISE produced improvements in memory     in community dwelling older persons. Transferring these exciting technologies to community     settings where they can benefit older adults is a pressing public health need. Therefore, the     current project seeks to transfer these two evidence-based interventions to older adults in a     rural state using senior centers as the venue for dissemination and lay health educators to     deliver the interventions. Senior centers are a particularly attractive context for     translation of evidence-based health promotion technologies in predominantly rural states     like Arkansas because they have a well-established infrastructure in communities and share a     common goal of promoting healthy aging and reducing health care costs. The 3-year randomized,     controlled trial will evaluate translation of the interventions by randomizing senior centers     (N=16) across Arkansas to implement either (1) the DPP Lifestyle Weight Loss Program or (2)     the SeniorWISE Cognitive Training Program. Older (age > 60) adults (N=288) nested within     senior centers will receive the programs delivered in a group format by a trained lay health     educator. Primary outcomes are changes in body weight and cognitive functioning at 12 months.     The multi-level evaluation plan will characterize reach, effectiveness, adoption,     implementation and maintenance of the interventions, with a cost effectiveness component.   "
145683|NCT01377493|"     There were no differences in the degree of enamel remineralization of subsurface lesions     among the chewing gums containing or not containing POs-Ca and fluoride.   "
145792|NCT01376063|"     The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the     plasma pharmacokinetic of rosiglitazone in healthy adult subjects.   "
145687|NCT01377441|"     The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has     not been studied extensively. Subjects are being asked to participate in this study because     they are scheduled for surgery and because the investigators want to study ways to improve     recovery from surgery. Ibuprofen will be given several times before and after surgery. The     investigators will ask questions to determine recovery and the investigators will draw blood     to determine inflammatory response.   "
145688|NCT01377428|"     The study will be a 12 week treatment (84 days), parallel group, randomized, double blind,     double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol     (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).      Patients will be enrolled after giving informed consent and then begin a screening/run-in     period for 14 days. Patients will be randomized to one of two treatment groups using an     allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to     formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of     12 weeks.   "
145689|NCT01377415|"     The investigators wanted to re-evaluate the effects of subacromial bupivacaine infusion after     shoulder arthroscopy with standard surgical techniques, including rotator cuff operations.     The investigators hypothesized that patients having 5.0 mg/ml bupivacaine infusion at a rate     of 2 ml/h subacromially would need less opioids than patients receiving a placebo infusion.   "
145690|NCT01377402|"     The first aim of this trial is to assess the long-term prognostic value of Omega-3 index,     which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to     other fatty acids in the erythrocyte membrane, in an unselected, regional multicenter     observational study of 982 chest pain patients admitted to the emergency unit, employing     blood samples collected at admission.      The second purpose of this study is to evaluate the prognostic utility of vitamin D in the     same population.      The third purpose of this study is to assess the incremental prognostic value of B-type     natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).   "
145691|NCT01377389|"     The goal of this clinical research study is to learn if ipilimumab in combination with either     Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect     prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also     want to learn if these drug combinations affect the body's immune system. The safety of these     drug combinations will also be studied.   "
145692|NCT01377376|"     The primary objective of this study is to determine if the combination regimen of ARQ 197     with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in     subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have     received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.   "
145693|NCT01377363|"     This is a Prospective Clinical Trial without drugs, to determine the HER2 status in the     metastasis of patients with primary breast cancer HER2. 236 patients have been recruited and     32 Sites have been taking part in this Clinical Trial.      Primary Objective:        -  To determine prospectively the probability of stage HER2 conversion between the          different subtypes of primary breast cancer (luminal, triple negative and HER2) and          their metastasis.      Secondary Objective:      - To determine the probability of changes in ER and PR between different subtypes of primary     breast cancer and their metastasis.        -  Analyze the variability in the measurement of HER2, ER and PR between local laboratories          and central laboratory.        -  Evaluate HER2 conversion rate compared to previously received treatment.        -  Evaluate whether the location of metastasis biopsied relates to the probability of          conversion of HER2.        -  Compare the disease-free survival (DFS) and survival post relapse (SPR) of patients with          or without conversion of HER2 and ER/PR.        -  Compare the response rate (RR) and time to progression (TTP) for subsequent anti-tumor          treatment of patients with or without conversion of HER2.        -  Analyze the extent to which discrepancies in the HER2 receptor status, ER and PR between          the primary tumor and metastasis alter the clinical management of patients.        -  Analyze the feasibility of performing biopsies.        -  Evaluate whether the HER2 status conversion really is associated with activation of          intracellular markers of the HER2 signaling pathway: pMAPK, PERK, pAKT, PTEN, PIGF-1R in          paired samples (primary tumor and their metastasis).        -  Check if there is any change in the molecular subtypes (luminal, triple negative, HER2)          between primary tumors and metastases in patients with HER2 conversion.   "
145695|NCT01377337|"     Out-of-hospital cardiac arrests (OHCA) account for over 60% of deaths from coronary artery     disease. The annual incidence of OHCA treated by Emergency Medical Systems (EMS) is 41-89 per     100,000 population. Outcome of OHCA and cardiopulmonary resuscitation (CPR) is very poor:     Less than 1/3 of the victims regain spontaneous circulation (ROSC), 40-60% of those achieving     ROSC suffer significant neurological disability due to brain hypoxia and only 1.7-6.4% are     discharged from the hospital. In order to minimize hypoxia time, the primary goal of CPR is     to achieve return of spontaneous circulation (ROSC) as fast as possible. Metabolic (lactic)     acidosis develops rapidly during CA and is considered detrimental to CPR outcome. Sodium     bicarbonate (SB), a generic, commonly used acid buffer, was subjected only to a single,     small, prospective controlled trial that found a trend towards improved outcome in prolonged     OHCA and CPR. Another study indicated that EMS's that used SB early and often during CPR had     significantly higher ROSC rates and better long-term outcome compared with EMS's that used SB     more seldom and administered it late in the course of CPR.      Aim of the Study:      To determine whether early administration of SB during OHCA and CPR improves short-term CPR     outcome.   "
145696|NCT01377324|"     The dose of fulvestrant to optimally downregulate estrogen receptors (ER) is currently     subject of debate. Effects of fulvestrant on the ERs may be evaluable by molecular imaging     using positron emission tomography with the ER-specific FES tracer. In this pilot study we     will evaluate the effects of the new dose of fulvestrant (500mg i.m.)on the availability of     ER binding sites in 15 metastatic breast cancer patients.   "
145697|NCT01377311|"     Name of the project：The application of cornea stem cells cultured on amniotic membrane in     patients suffering from corneal stem cell insufficiency      Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell     cultured on amniotic membrane for treatment of patients suffering from limbal stem cell     insufficiency   "
145698|NCT01377298|"     Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity     profile comparing with sunitinib, the investigators plan this phase II trial of pazopanib in     cisplatin-refractory recurrent or metastatic HNSCC.   "
145793|NCT01376050|"     The purpose of this study is to determine whether low level laser light therapy is effective     as an adjunctive therapy to the healing of venous stasis leg ulcers.   "
145794|NCT01376037|"     The purpose of this study is to determine if the Erchonia® ML Scanner (MLS) low level light     laser device can help to reduce the circumference of the upper arms.   "
145699|NCT01377285|"     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial to     investigate the renoprotective efficacy of combined pentoxifylline (PTX) and angiotensin     receptor blockers (valsartan), compared with placebo and valsartan in 700 patients with     Chronic Kidney Disease (CKD) stages 3 and 4. The effect on cardiovascular comorbidity will     also be observed. The observation period will be 3 years. The primary endpoints consists of     doubling of serum creatinine, end stage renal disease (ESRD), and death from any cause. The     secondary endpoints include changes of microalbuminuria or proteinuria, serum and urinary     levels of TNF-a(tumor necrosis factor-alpha ), MCP-1(monocyte chemotactic protein),     TGF-beta1(transforming growth factor ), collagens III (amino terminal peptide of procollagen     III) and IV, and fibronectin, urinary N-acetyl-beta-glucosaminidase, as well as serum     fibrinogen and high-sensitive CRP(C reactive protein), and development of heart failure,     nonfatal myocardial infarction, and stroke or transient ischemic attack.   "
145700|NCT01377272|"     Data will be extracted from the National Taiwan University Hospital (NTUH) medical records     database, geocoded according to the street address so that the case number, incidence, etc     could be mapped. The spatial data would be used to detect the aggregation of HIV cases,     existence of hot spots and then determine if they may merit further investigation or may     have occurred by chance. The results from these GIS-based analyses would address local     variations in HIV prevalence and transmission.   "
145701|NCT01377259|"     Neuraxial anesthesia affords a less interventional way to desensitization of the lower body     for surgical procedures. After introduction of neuraxial anesthesia, vasodilatation of body     part below the anesthetic level is theoretically appeared as the sympathetic nerve efferent     is blocked. The vasodilatation effect is related to hypotension, hypothermia, shivering and     the response of volume redistribution. It is believed that vasodilatation leads to better     regional tissue perfusion and better regional tissue oxygenation. Previous reports of laser     doppler flowmetry and thermography showed their effectiveness on monitoring blocked level but     they were not easily available in the operation room. Recently Near-infrared     spectroscopy(NIRS) demonstrates real-time tissue oxygen saturation(rSO2) which is applied     generally in non-invasive brain oximeter. We use NIRS in spinal anesthesia to monitor the     tissue oxygenation change over the upper and lower limbs during the induction of neuraxial     anesthesia.   "
145702|NCT01377246|"     The general aim of the trial is to assess the efficacy of one year treatment with long-acting     somatostatin analogue (Octreotide LAR) compared with placebo in slowing kidney and liver     growth rate in patients with ADPKD and moderate/severe renal insufficiency and to assess     whether and to which extent this translates into slower renal function decline over 3-year     follow-up.   "
145703|NCT01377233|"     The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics     of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.   "
145704|NCT01377220|"     Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver.      Recently, several research studies reported that 11C-choline PET has shown a high detection     rate of well differentiated HCC, which is an early stage of primary liver cancer. The aim of     this study was to prospectively evaluate the diagnostic accuracy of 11C-choline PET-CT to     detect HCC in cirrhotic or non cirrhotic patients.   "
145705|NCT01377207|"     Recent studies suggest important gender differences in the pathophysiology and prognosis of     ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled     study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus     formation in patients presenting with STEMI treated with primary angioplasty. Gender-related     mechanisms of plaque rupture or erosion will be investigated using a combination of     Quantitative Coronary Angiography, high resolution Optical Coherence Tomography of the     culprit vessel and histopathologic analyses of thrombus aspirates of the infarct related     lesion, performed by independent core laboratories, blinded to group (male or female) and     clinical variables.   "
145707|NCT01377181|"     The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic     hernia repair is especially advantageous for bilateral diseases and minimally invasive     technique in children because it avoids vas injury. However, the problem of recurrent rate     has not been resolved. The aim of this study was to refine the current criteria used the     lateral umbilicus ligament covering the internal hernia opening region, and eliminated     recurrence in laparoscopic inguinal hernia (LIH) repair in children. The investigators     hypothesized that the lateral umbilicus ligament covering the internal hernia opening region     after the laparoscopic purse-string knot would result in lower recurrence and the same     operation relative complication   "
145708|NCT01377168|"     This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be     randomized to receive either oral naltrexone for the treatment of alcohol use disorder or     placebo. Men with acute, recent or established HIV infection will receive antiretroviral     treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is     to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral     load suppression, among men with alcohol use disorder. The study will also assess the impact     of oral naltrexone on alcohol use behaviors in this population.   "
145709|NCT01377155|"     This study will evaluate two methods of starting basal insulin to see which method may     achieve a faster-to-goal titration.   "
145710|NCT01377142|"     The purpose of this study is to evaluate surgical success or failure one year after surgery     for pelvic organ prolapse.   "
145711|NCT01377129|"     The main objective of this study is to compare, using MRI measures with a specialized splint,     the persistent rotatory laxity after anterior cruciate ligament reconstruction using single     bundle and double bundle surgical techniques, between the seventh and eighth months after     surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).   "
145712|NCT01377103|"     The purpose of this study is to evaluate whether benefits of topical testosterone on symptoms     and function of male HF patients, and its effects on rehospitalization rates and quality of     life.   "
146085|NCT01372163|"     The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after     administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to     evaluate the plasma drug concentrations after multiple doses.   "
145714|NCT01377077|"     Rationale: Punch grafting is a safe, simple and widely used technique for in vitiligo.     However, no reliable data are available on the effect of punch depth and punch size.      Objectives: Primary: to compare the efficacy and safety of different punchdepths and     punchsizes in punch grafting in patients with segmental and non-segmental vitiligo.     Secondary: to assess the practical aspects and patients preference of different punch     grafting techniques.      Study design: Prospective observer blinded randomised controlled study. Study population: 35     patients ≥ 18 years with segmental or stable non-segmental vitiligo who will receive regular     treatment by punch grafting at the Netherlands Institute for Pigment Disorders (SNIP) at the     Academic Medical Centre University of Amsterdam.      Methods: Four depigmented regions on the trunk or upper extremities will be randomly     allocated to either epidermal 1,5 mm punch grafting, epidermal 1mm punch grafting, dermal 1,5     mm punch grafting and dermal 1 mm punch grafting. After grafting, all regions will receive     UV-therapy twice a week for 3 months. Three and six months after grafting, the repigmentation     of the lesions will be assessed by measuring the outgrowth.      Main study parameter/endpoint: Outgrowth of pigment after six months.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: The study involves 16 additional punch grafts but no additional visits to our     institute. Patients will not miss any regular treatment. The extra time due to participation     in the study will be about 40 minutes. No increase of the risk of side effects is expected by     placing 16 additional punch grafts. 1.   "
145715|NCT01377064|"     Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living longer,     but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise and     increased physical activity can reduce the risk factors for these diseases in PLWHA, but no     studies have tested an at-home exercise program that would benefit low income people and     others who do not have access to exercise facilities. This study will test the feasibility of     an at-home exercise program for PLWHA and prepare for a full-scale intervention study, which     may lead to a reduction in CVD risk among PLWHA.   "
145716|NCT01377051|"     The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is     effective in the acute treatment of COPD and in particular on reducing lung hyperinflation     and dynamic volumes.   "
145717|NCT01377038|"     The primary objective of this study is to evaluate the relative efficacy of a     centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical     diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary     objectives include the determination of which self-report and experimental pain measures best     differentiate those who respond better to duloxetine than diclofenac.   "
145718|NCT01377025|"     Uveal melanoma is the most common primary intra-ocular malignancy in adults with an incidence     of 0.6 - 0.7 per 100,000 per year.      Prognosis of metastatic uveal melanoma is poor. In retrospective analyses a median survival     time after detection of metastases of 5 months (Flaherty et al, 1998) and 7 months (Kath et     al, 1993) was reported. For patients receiving no treatment reported median survival was 2.0     months compared with 5.2 months for those receiving treatment for metastases (Gragoudas et     al, 1991).      Up to now there is no established treatment of metastatic uveal melanoma. Some therapeutic     approaches with locoregional treatment or systemic chemotherapy have been undertaken:      In case of metastatic disease which is confined to the liver in about 85% of patients with     uveal melanoma surgical resection led to a median survival of 14 months (Mariani et al, 2009)     or 19 months and a 5-year survival rate of 22% in a selected patient population (Adam et al,     2006).      As locoregional treatment option treatment with fotemustine via direct intra-arterial hepatic     infusion was investigated and led to a median survival of 15 months (Peters et al, 2006).     This was not a randomized trial, but a report on 101 consecutive treated patients. Additional     debulking surgery was performed whenever feasible.      A randomized phase III trial comparing intra-arterial hepatic fotemustine administration with     intravenous systemic fotemustine and overall survival as primary endpoint is still ongoing     (EORTC 18021).      Thus, no systemic chemotherapy is approved for metastatic uveal melanoma. Although no     specific genes have been linked to the pathogenesis of uveal melanoma, preclinical studies     suggest potential benefit of inhibitors of Bcl-2, ubiquitin-proteasome, histone deactylase,     mitogen-activated protein kinase and phosphatidylinositol-3-kinase-AKT pathways, and receptor     tyrosine kinases.      Thus, sorafenib as inhibitor of b-Raf and Raf-1 (c-Raf or c-Raf-1), pro-angiogenic vascular     endothelial growth factor receptor (VEGFR), and platelet-derived growth factor receptor     (PDGFR) may potentially lead to a benefit for patients with metastatic uveal melanoma in     terms of disease control and prolongation of survival.   "
145719|NCT01377012|"     The core and extension studies assessed the safety and efficacy of secukinumab when added to     a background therapy in patients with active rheumatoid arthritis who are intolerant to or     have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab,     placebo. The core study was completed. However, the extension study was terminated early     (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy     of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading     to closing of the AIN457 RA program.   "
145720|NCT01376999|"     The aim of the study is to evaluate if the Step up protocol is equal or superior regarding     efficacy and security than the step down protocol. In couple submitted two intrauterine     insemination.   "
145721|NCT01376986|"     The aim of the study is to investigate different novel IC technologies for promoting physical     activity and health and preventing obesity in young men. The purpose is to provide new     evidence-based knowledge on the effectiveness of an ICT-based physical activation and to     identify factors predicting a positive response.      Specific objectives        -  to identify the factors associated with physical activity and physical activity          relationship in young men        -  to develop an interactive method, based on peer networks, aimed at activating young men          with use of their own skills, participation and modern ICT        -  to assess the effectiveness of the chosen activation on the physical activity, weight,          fitness, health, and relationship towards physical activity among young men      The study population consists of all conscription aged men in the Oulu area in 2011-2013     (n=4000). Conscription-aged men provide a large, population based representative sample of     young men. In Finland military service is mandatory and annually all 18-year old men are     called for military service. In the call-ups fitness for service is determined based on     medical examination.      All those who are determined fit for service or who are granted postponement due to obesity     will be invited for the activation intervention study. Those with severe obesity are exempted     from service, but will also participate in the trial. After the call-up, the men will be     randomised to an intervention group and a control group. The primary outcome variable is     change in physical activity.      The study will be conducted during 2011-2015. The study includes technology development (ICT     platform), collection of cross-sectional data at the call-ups, and a 6-month physical     activity intervention (a randomized controlled trial) implemented between the call-up and     start of military service. Game mechanics are integrated into the ICT platform to increase     user engagement and participation.      Physical activity, fitness (aerobic and muscular), body composition,lifestyle and     psychological and physical health will be followed. In addition, the subjects' entry into     military service and its course will be followed.   "
145722|NCT01376973|"     Stress is an important cause factor of temporomandibular disorder (TMD) and Police Officers     are exposed to stress. Aim of the study was to evaluate clinical and electromyographically     the effect of two different occlusal splints on police officers with TMD   "
145817|NCT01375738|"     This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in     patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood     glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to     evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in     gastric cancer patients with diabetes.   "
145723|NCT01376960|"     The purpose of this study is to compare, for the first time ever, single shot popliteal fossa     blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The     primary outcome variable for this study is the percentage of patients that convert to general     anesthesia following either a single shot popliteal fossa block or ankle block.      H0: There is no difference in the percentage of patients that convert to general anesthesia     between single shot popliteal fossa blocks and ankle blocks.      HA: There will be a lower percentage of patients receiving a single shot popliteal fossa     block that convert to general anesthesia compared to patients receiving an ankle block.   "
145724|NCT01376947|"     In this study the investigators compare the difficulty at insertion of IUD between     nulliparous and parous women. The investigators compare the pain reported by the patient to     the difficulty reported by the professional that performed the insertion.      The investigators hypothesis is that there is no difference between nulliparous and     multiparous patients.   "
145725|NCT01376934|"     Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine     cavity and investigate of abnormal uterine bleeding . The success of the procedure is based     on the distension of the cavity . It can cause pain and discomfort and sometimes the     procedure fails. . There are two techniques to make the procedure , one with gas and the     other with saline solution. Objective: to compare two techniques concerning pain , procedure     duration and image quality   "
145726|NCT01376921|"     This is a Spanish, Multicentre, Observational Study to study adherence and long term outcomes     of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone     treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.   "
145727|NCT01376908|"     This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate     efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in     less than 4 year-old infants and children with phenylketonuria (PKU).   "
145728|NCT01376895|"     The goal of this study is to develop and test a program to help Black men who have sex with     men and women reduce their chances of getting or giving HIV infection to their sex partners.     The program is designed to be delivered via the internet so that it would be available to     more men. Men who agree to participate in the study will be assigned by chance to receive the     POWER intervention or a similar program that is focused on general health called     POWER-HEALTH. They will also complete a computer administered interview when they first     enroll in the study, 2 weeks following the last session of the program and 3 months after     that. Participants will receive a small compensation for their time and effort.   "
145729|NCT01376882|"     The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as     compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood     flow effects will also be assessed in a subset of participants. The role of caffeine     abstinence/maintenance in the acute effects of caffeine will also be explored.   "
145730|NCT01376869|"     Hops have been used for many years for their supposed sedative and anxiety reducing     properties and can be found in many natural remedies for stress, anxiety and sleeping that     are already available to buy.      However, human trials investigating the effects of hops have so far been limited to the     effects of the combination of hops and valerian in relation to sleep. Such studies have     identified that a valerian-hops mixture can result in improved sleep but Valerian alone has     no effect.      The current study aims to investigate the effect of hops alone in healthy human participants     aged 18-35 years.   "
145731|NCT01376856|"     The purpose of this study is to analyze pathologic and radiologic characteristics of     mediastinal lymph nodes with false positive FDG PET/CT results in lung cancer staging and     assess relationship between false positive mediastinal lymph node and TB/latent TB.   "
145733|NCT01376830|"     Respiratory virus infections are a common cause of COPD exacerbations and antiviral therapies     have potential as treatments for exacerbations. However it is likely that treating patients     when they present with an exacerbation with antiviral drugs will be too late to be effective     and earlier treatment at the time of the initial upper respiratory tract infection (URTI)     will be required. The incidence of exacerbations following URTIs in COPD patients, and     whether there are host factors and biomarkers that can identify the risk of this, is unknown.     The aims of this study are to establish the proportion of viral URTIs that progress to an     acute exacerbation in COPD patients and identify clinical, viral and biological markers that     predict risk of an exacerbation following an URTI. In addition we will determine the     frequency of, and risk factors for, bacterial infection following viral URTIs in COPD     patients. This data will permit development of a model combining baseline patient     characteristics, clinical measurements and biomarkers to predict exacerbation risk following     viral URTI in COPD patients. The results will open the way for trials of antiviral therapy in     COPD exacerbations and targeting of treatment to high risk patients.   "
145734|NCT01376817|"     The purpose of this study is to comparatively assess the potential antiinflammatory effects     of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil     versus intravenous lipid emulsions made exclusively with MCT and LCT on the evolution of     patients with severe acute pancreatitis during the period in needing artificial nutrition     support with total parenteral nutrition so unique.   "
145735|NCT01376804|"     This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte     (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant     recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte     orally daily for up to 200 days post-transplant and will be followed for 52 weeks     post-transplantation.   "
145736|NCT01376791|"     We propose to examine a population of Native Americans who have had little or no dental care,     and to determine if periodontal disease is associated with early signs of vascular     dysfunction or systemic inflammation. We then propose to treat the periodontitis and     re-evaluate vascular function. We will determine if gingivitis or mild/moderate periodontitis     is associated with detectable vascular dysfunction. Microbial metagenomics will be correlated     with vascular function.   "
145737|NCT01376778|"     Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects.     When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue,     weakness, fever, swollen glands). Most people in the United States are infected during     childhood or as adults if they work around children. Pregnant women, who have not been     infected with CMV in the past and become infected during pregnancy (i.e. a primary     infection), may cause their babies to get infected with CMV. Babies that are infected may     develop permanent disabilities including hearing loss and a small portion will die from the     infection.      Currently it is not routine practice to screen pregnant women for CMV infection.     Additionally, there is no agreement about how to evaluate and manage pregnant women infected     with CMV for the first time. There is also no evidence that treatment is beneficial for the     baby.      The purpose of this research study is to determine whether treating pregnant women who have a     primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.   "
145738|NCT01376765|"     This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study.     Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and     Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by     Protein Sciences Corporation), two doses, administered at 28 day interval. 1. S Protein     Severe Acute Respiratory Syndrome (SARS) Vaccine without adjuvant: 5.0, 15.0 and 45.0 mcg per     0.5 ml dose. 2. S Protein SARS Adjuvanted Vaccine: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose.     PLACEBO: diluents/placebo without vaccine (Phosphate Buffer Saline (PBS) with lower phosphate     concentration). Approximately 84 healthy male and nonpregnant female subjects 18 to 40 years     of age will be enrolled.   "
145739|NCT01376752|"     CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial     ovarian cancer is able to improve the median OS by 12 months. In that hypothesis, with alpha     risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years     follow-up, the number of patients to include is 404. Taking into account a 10% failure, an     overall number of 444 patients is required.   "
145740|NCT01376739|"     This study is a regulatory post-marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received Magnevist at a dose of more     than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging from the     abdomen to the lower extremities. The objective of this study is to assess safety, especially     in relation to renal dysfunction, and efficacy of using Magnevist in clinical practice. A     total 2,000 patients will be recruited.   "
145741|NCT01376726|"     The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in     healthy, HIV-uninfected adults who have participated in a previous HIV vaccine clinical trial     and in healthy, HIV-uninfected adults who have not participated in a previous HIV vaccine     clinical trial.   "
145742|NCT01376713|"     The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w     Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable     stage III or stage IV melanoma.   "
145743|NCT01376700|"     The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg     ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype     (ie, joint bleeding), together with the minimization of immunological danger signals, can     reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe     hemophilia A.   "
145744|NCT01376687|"     Back pain affects the majority of the population at some time. Currently there are no     published and scientifically accepted objective measures to support manual medicine     diagnostic and treatment techniques for back pain. The purpose of this project is to collect     and evaluate objective (pressure and motion) data from standard clinical diagnostic tests.   "
145899|NCT01374633|"     Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure     (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped     with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12     hours. Sedation will be controlled with BIS.   "
145745|NCT01376674|"     Immunological effects of radiotherapy have been described before, but not evaluated in a     time-dependant manner.      In order to identify a possible time frame for combination therapies, white blood cells are     isolated of samples taken at different time points before during and after standard     radiotherapy in patients with localised prostate cancer. The overall activity of the     T-cell-system as well as tumor-specific T-cell-response are evaluated.   "
145746|NCT01376661|"     The purpose of this research study is to monitor the feasibility and outcome of the Active     Surveillance Program for men with low risk prostate cancer.   "
145747|NCT01376648|"     Brown adipose tissue (BAT) is important in energy expenditure through thermogenesis although     the regulatory factors are not well known in humans. There is evidence suggesting that the     thyroid hormones affect BAT functions in lower mammals, but the effects of the thyroid     hormones on BAT activity in humans are still unclear. The objective of this study was to     investigate the effects of thyroid hormones on glucose metabolism of BAT and other organs in     humans.   "
145748|NCT01376635|"     Background/Aims: To evaluate the sympathovagal balance in patients with chronic kidney     disease (CKD) on conservative treatment. Methods: In a cross-sectional study, patients with     CKD stages 3, 4 and 5 not yet on dialysis (CKD group) and age-matched healthy subjects (CON     group) underwent continuous heart rate recording during two twenty-minute periods in the     supine position (pre-inclined), followed by passive postural inclination at 70° (inclined     period). Power spectral analysis of the heart rate variability was used to assess the     normalized low frequency (LFnu), indicative of sympathetic activity, and the normalized high     frequency (HFnu), indicative of parasympathetic activity. The LFnu/HFnu ratio represented     sympathovagal balance.   "
145749|NCT01376622|"     Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands,     particularly the pituitary gland, remains common in patients with transfusion dependent     anemias. We would like to establish accurate population norms of pituitary R2 and volume and     understand the progression of pituitary iron in transfused patients on Deferasirox.   "
145750|NCT01376609|"     Previous research has shown there wasn't inevitable relationship between mismatch area and     infarct growth according to Volumetric-subtraction mismatch volume.The recently published on     Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace     ischaemic penumbra, and it reignites hope for clinical application of the PWI/DWI mismatch.     But the correlation between the mismatch, calculated by Coregistration mismatch method,and     the clinical outcome of the patients with acute ischemic stroke is still unknown. so the     investigators plan to conduct a prospective observational cohort study.   "
145751|NCT01376596|"     This study will explore the helpfulness of a short psychological group treatment called     cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and it     aims to improve difficulties that are related to behaviors and emotions by first working on     identifying and changing negative inaccurate thoughts. The main goal of this intervention is     to see if group CBT reduces the symptoms of social anxiety in people with schizophrenia so     that they can improve their social functioning and help their psychotic symptoms. The study     compares the usefulness of adding CBT to standard services.   "
145752|NCT01376583|"     The study investigates the explanation for the positive relation found between exercise and     breastcancer.   "
145753|NCT01376570|"     This study will test whether contingency management (monetary vouchers contingent on     abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads     to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a     randomized controlled trial, the investigators propose to test whether an     abstinence-reinforcing contingency management intervention improves viral load suppression in     HIV-infected drug users.   "
145754|NCT01376557|"     This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in     combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate     glycemic control on metformin monotherapy.   "
145755|NCT01376544|"     During assist control ventilation and pressure support ventilation (PSV), the start of     ventilator inflation is determined by the start of the infant's inspiratory effort. During     PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In     a randomized trial, no significant differences were found between assist control and pressure     support ventilation with regard to the duration of weaning, time to successful extubation,     work of breathing, rate of asynchrony and level of respiratory muscle strength.   "
145756|NCT01376531|"     The aim of the study is to characterize the influence of continuous veno-venous hemodialysis     on the cerebrovascular autoregulation.   "
145757|NCT01376518|"     The aim of the present study is to characterize the influence of an elevated positive     end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung     injury on the cerebrovascular autoregulation.   "
145758|NCT01376505|"     This phase I trial studies the side effects and best dose of vaccine therapy in treating     patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined     with tumor cells may help the body build an effective immune response to kill tumor cells.   "
145759|NCT01376492|"     The purpose of this study is to establish the relationship between performance of patients     with schizophrenia and relationship with perceived quality of sleep. The secondary objectives     are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to     assess the potential epidemiological risk factors associated with the perceived impairment of     quality of sleep; to establish the relationship between the clinical condition and the     quality of sleep perceived; to assess the performance level of patients.   "
145760|NCT01376479|"     The purpose of this study is to evaluate the safety and immune response of an inactivated     vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).   "
145761|NCT01376466|"     The purpose of this study is to determine whether computed tomography is reliable     investigation in the diagnosis of acute appendicitis.   "
145784|NCT01376167|"     The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with     Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the control     Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be     co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the     selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax     Malaria.   "
145762|NCT01376453|"     The main purpose of this study is to find the maximum tolerable dose of sorafenib when     administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about     whether these drugs, along with radiation, can help people with rectal cancer when given     before surgery. 5-FU and radiation are both approved by the US Food and Drug Administration     (FDA) for use in people with rectal cancer.      The investigators will utilize a standard 3 + 3 phase I study design. In the phase I part of     the study, the investigators will attempt dose escalation of sorafenib in combination with     standard infusional 5-FU and external beam at standard doses. Clinical staging should be done     by endorectal ultrasound (ERUS) and/or pelvic magnetic resonance imaging (MRI) for T and N     stage; chest and abdomen computed tomography (CT) for staging of metastatic disease; undergo     sigmoidoscopy and/or colonoscopy done by crude odds ratios (CORS); biopsy is taken for     diagnosis and extra is sent for tissue bank. At the maximum tolerated dose (MTD) of sorafenib     we will expand the cohort to 6 more patients to further evaluate toxicity profile and     efficacy.   "
145763|NCT01376440|"     The Millenium development goals (MDGs) call for reducing by half the proportion of people     without sustainable access to safe drinking water. This goal was adopted in large part     because safe drinking water has been seen as critical to fighting diarrheal disease. Source     protection is considered the main intervention area to achieve this goal. However, research     worldwide that has shown that even drinking water which is safe at the source is subject to     frequent and extensive fecal contamination during collection, storage and use in the home.     This contamination is through the introduction of cups, dippers or hands, contamination by     flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can     pose infectious disease risks if they become contaminated due to unsanitary collection,     storage conditions and practices within households.      To reduce this problem, point-of-use water treatment has been advocated as a means to     substantially decrease the global burden of diarrhea and to contribute to the MDGs. However,     research indicates that there are many unanswered questions around Household water treatment     (HWT) that require small or medium scale epidemiological studies and randomized controlled     trials, especially with regard to effectiveness, acceptability and identifying suitable     target populations. Some of the most urgent questions to be resolved are:(1) How much of the     currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on     nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted?     (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease     is high.      hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive     children? hypothesis: Do household water treatment with chlorine acceptable in the community?   "
145764|NCT01376427|"     This study proposes to provide adequate treatment and is based on current scientific evidence     for elderly patients with ALL Bcr / Abl positive.      To determine whether low-dose chemotherapy associated with imatinib or dasatinib has     acceptable tolerability in elderly patients.      To determine whether this association can increase the rate and quality of referrals to the     results of the literature of imatinib as monotherapy for elderly patients   "
145765|NCT01376414|"     This pilot study aims to estimate the prevalence of Helicobacter pylori (H. pylori)     colonization in patients presenting with non-specific abdominal pain (NSAP) in an urban     academic emergency department (ED) located in Washington, DC.   "
146086|NCT01372150|"     This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release     vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive     Disorder (MDD).   "
145766|NCT01376401|"     This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy     (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone     (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or     unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous     transplant receive four cycles of BVP, hematopoietic stem cell collection and administration     of two cycles BVP over followed by autologous transplant.      In addition to the overall response rates, will also be analyzed time to progression (TTP),     progression-free survival (PFS) and overall survival.      Finally, the results will be compared with BVP with those obtained in 120 patients included     in our protocol VMP GEM10MAS65.      Patients will be evaluated at scheduled visits up to 3 periods of study:      pretreatment, treatment and monitoring.   "
145767|NCT01376388|"     The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444     Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry     Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary     Disease (COPD). This is a multi-centre, open-label study evaluating the safety of     GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the     morning. The target enrolment is approximately 120 subjects at approximately 20 study centres     in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a     7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects     meeting all of the inclusion criteria and none of the exclusion criteria at screening visit     (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of     baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2,     eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment     period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily     in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects     will be instructed to administer medication once daily in the morning for the duration of the     52-week treatment period. Each subject should be advised to adhere to this dosing regimen     throughout the study. There will be a total of 8 study visits including at screening (Visit     1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks,     52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by     the phone contact approximately 1 week following the completion/withdrawal of treatment     period. A subject will be considered to have completed the study upon completion of the last     on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed     appropriate COPD medication at the investigator's discretion.   "
145768|NCT01376375|"     Background:      - Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate     specific points in the body. Previous studies have found that acupuncture can be useful in     treating low back pain. This study will explore how acupuncture affects low back pain.     Researchers will look at blood samples for changes in different chemicals related to     inflammation and pain.      Objectives:      - To test the effect of acupuncture on blood chemicals associated with chronic low back pain.      Eligibility:        -  People at least 18 years of age who have chronic low back pain.        -  Those who have had back surgery or had acupuncture for any medical condition may not          participate.      Design:        -  This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2 hours.        -  At the first study visit, participants will give a medical history and complete two          questionnaires about their low back pain. They will also spend 30 minutes lying down on          a bed, relaxing quietly.        -  The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will          receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic          the standard procedure, but no needles will be used. The standard procedure will be          performed in the same location. A licensed, experienced acupuncturist will insert small          disposable needles into acupuncture sites on the back, arms, and legs. Those in the          study will not know whether they are receiving the sham or the standard acupuncture          procedure.        -  At some visits, participants will provide blood samples for testing. At every visit,          participants will complete the questionnaires about low back pain.   "
145771|NCT01376336|"     Environmental health-related pathogens include faecal-oral, diarrhoeagenic microbes that may     be transmitted via drinking water and are related to sanitation and hygiene. Previous     research has suggested that safeguarding household drinking water against recontamination may     be a critical intervention that can reduce risks of diarrheal diseases and may be especially     important for people living with HIV/AIDS (PLWHA) and other vulnerable populations (Clasen et     al. 2007). The investigators propose here a randomised, controlled trial of a household safe     storage container for drinking water in a well defined, HIV-impacted population in peri-urban     Lusaka, Zambia. After a baseline data collection period (9 months) half of all households     (150 households) will be given a safe water storage container specifically designed to     prevent recontamination of water in household use. All households will be followed for an     additional 9 months. Results of this study will help determine whether this promising water     quality intervention can reduce diarrhoea and related outcomes in this and similar vulnerable     populations.   "
145772|NCT01376323|"     The aim of this combined, two part study is to evaluate the safety and glucose lowering     effects of GSK256073 when administered to diabetic subjects for 12 weeks.   "
145773|NCT01376310|"     This is an open-label study which will permit subjects with solid tumors or leukemia, who are     currently clinically benefitting on another GSK sponsored trial with GSK1120212 either     monotherapy or in combination continued access to GSK1120212.   "
145774|NCT01376297|"     NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two     antiemetic drugs, both given with oral dexamethasone. The objective of the study is to     evaluate if netupitant and palonosetron are safe when administered to prevent nausea and     vomiting after administration of repeated cycles of chemotherapy.   "
145775|NCT01376284|"     The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg     collected from the required number of Japanese subjects with benign prostatic hyperplasia     (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its     use at post-marketing clinical settings.   "
145776|NCT01376271|"     The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use     in Japanese Social Anxiety Disorder (SAD) subjects.   "
146087|NCT01372137|"     This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to     identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in     patients with anemia of chronic disease (inflammation).   "
145777|NCT01376258|"     Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be     associated with improved clinical outcomes for patients with enlarged prostates (EP) and     lower health care related costs.      The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and     length of therapy and the likelihood of acute urinary retention (AUR), prostate-related     surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or     prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and     Medicare population. The null hypothesis is that no differences will be observed in the     outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The     test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period     of time will experience significantly fewer adverse outcomes and significantly lower     treatment costs.      The data source for this analysis is the MarketScan database, which contains medical and     pharmacy claims for commercial health plan members and Medicare recipients. Medical and     pharmacy claims data are sourced directly from health plans and employers. The database     represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid     enrollees from multiple states. The database includes the Medicare-covered portion of     payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary.      The study design is a retrospective cohort analysis. Each patient's index date was defined as     the date of the first fill for a 5ARI prescription.   "
145778|NCT01376245|"     The purpose of the study is to investigate the efficacy and safety of fluticasone     furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period     in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).   "
145779|NCT01376232|"     Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an     Inhibitor of CYP2C8 (gemfibrozil),]   "
145780|NCT01376219|"     The economic cost of asthma is considerable both in terms of direct medical costs (such as     the cost of pharmaceuticals and hospital admissions) and indirect medical costs (such as time     lost from work and premature death).      The costs of asthma depend on the severity of disease and the extent to which exacerbations     are avoided. Moreover, poor control of asthma symptoms is a major issue that can result in     adverse clinical and economic outcomes.      According to GINA guidelines, the goal of asthma treatment is to achieve and maintain asthma     control. Such an objective can be reached in a majority of patients with a pharmacologic     intervention strategy developed in partnership between the patient/family and the doctor.     Validated measures for assessing asthma control score goals as continuous variables and     provide numerical values to distinguish different levels of control. Among them, the Asthma     Control Test (TM - QualityMetric Incorporated) is widely recognized. Few data exist on the     relationship between asthma control and health care consumption.      Some models for predicting asthma costs have been proposed. However, these models only     attempt to assess costs associated with medications and/or asthma exacerbations. Furthermore,     in such studies, asthma control was not defined accordingly to current international     criteria.      Considering the increasing interest of health authorities in reducing asthma associated costs     and improving quality of care, it appears necessary to study the relationship between the     cost and the level of control.   "
145781|NCT01376206|"     To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray     in Japanese subjects with allergic rhinitis under the practical use conditions   "
145782|NCT01376193|"     The study is designed to investigate the information on safety and efficacy of naratriptan     tablets on Japanese subjects with migraine headache during Japanese post-marketing     surveillance period.   "
145783|NCT01376180|"     The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to     collect information for using lamotrigine tablet effectively and safely as well as to grasp     onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women,     subjects with poor renal and hepatic functions.   "
145786|NCT01376141|"     The study is designed to detect adverse drug reactions (particularly clinically significant     adverse drug reactions) occurring in clinical settings, to examine factors likely to affect     the safety and efficacy of sumatriptan tablet, and to discuss the need of special     investigation and postmarketing clinical study.      A special focus was placed on the investigation of occurrence of ischaemic heart     disease-like events including arrhythmia, angina pectoris, and myocardial infarction in the     present study.   "
145787|NCT01376128|"     The objectives of this survey was to retrospectively collect and evaluate the information on     the efficacy and safety of PAXIL tablets (PAXIL, hereinafter) in pediatric subjects (aged     under 18) with panic disorder under conditions of actual use.   "
145788|NCT01376115|"     To investigate safety and efficacy on Japanese subjects treated with nelarabine injection for     intravenous use in clinical settings of the following diseases:        1. T-cell acute lymphocytic leukemia (T-ALL)        2. T-cell lymphoblastic lymphoma (T-LBL) Also, any adverse events involving neurological          disorder, hypotension, and blood disorder and their details are to be investigated as          an item of particular concern. In addition, subject outcome (alive or dead) at one year          after the start of treatment will also be investigated.   "
145789|NCT01376102|"     This is an open label, multi-centre, non-interventional post-marketing surveillance   "
145790|NCT01376089|"     The purpose of this study is to evaluate and compare overall patient comfort profile between     the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast     media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed     Tomographic (CECT) imaging of the abdomen/pelvis.   "
145791|NCT01376076|"     This study will evaluate the effects of sequential multiple dose regimens of cariprazine on     cardiac repolarization in patients with schizophrenia.   "
145795|NCT01376024|"     The study hypothesizes that there exist effective non-operative and operative treatments for     certain patient populations with basal joint arthritis of the thumb. There also exists a     functionally superior, cost effective, and low risk non-operative or minimally invasive     operative treatment regime to alleviate pain and slow the progression of disease in those     with less advanced disease. Likewise, there is significant functional, health utility, and     economic advantage to surgically treating advanced basal joint arthritis with one of the     popularized procedures currently in practice.      Arthritis at the base of the thumb is a common condition associated with considerable patient     discomfort. Many non-operative and operative treatments have been described, but few     prospective studies involving multiple centers comparing these treatments have been done. By     following patients from the start of their arthritis treatment and assessing their progress     at certain time points using questionnaires and radiographs the investigators believe patient     outcomes and satisfaction can improve. This study will include patients who are treated     non-operatively and operatively and will not change patients' standard of care. By     establishing standardized outcome measures and collecting data prospectively from the time of     initial presentation through all treatment interventions it will be possible to directly     compare treatments during the conservative and operative care of basal joint arthritis of the     thumb. This multi-center study will identify those specific procedures or conservative     treatments that have the greatest potential to be studied in subsequent focused and     well-designed randomized control trials.   "
145796|NCT01376011|"     The purpose of this study is to find out if quercetin can increase blood levels of     hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a     corresponding increase in blood flow to the brain.   "
145797|NCT01375998|"     This study is a regulatory post marketing surveillance in Japan, and it is a local     prospective and observational study of patients who have received YAZ for dysmenorrhea. The     objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A     total 3,000 patients will be recruited and followed 3 years since starting YAZ     administration.   "
145798|NCT01375985|"     The purpose of this study is to characterize the safety and pharmacology of single     administrations of AVI-7100, a candidate treatment for influenza.   "
145799|NCT01375972|"     To select a better agent between S-1 or gemcitabine in combination with cisplatin for the     conventional chemotherapy platform for future development in advanced Biliary Tract     Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and     cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.   "
145800|NCT01375959|"     Resveratrol is a substance found in many plants, including grapes and red wine, which is     widely used as a nutritional supplement. Studies in cells and lower animals show that     resveratrol has many potential benefits, including prolonging lifespan, preventing cancer and     heart disease and normalization of glucose metabolism. Although use of this agent shows great     promise in the treatment and/or prevention of diabetes, there have been no studies reported     to date in humans. As an initial step, this proposal is for a 6 week pilot study of     resveratrol treatment in older adults with impaired glucose tolerance (IGT) in order to     explore its effects on post-meal blood glucose metabolism. Preliminary studies will also be     conducted to explore how resveratrol works by studying cellular function (in muscle samples     obtained from study participants) and by testing resveratrol's effect on blood vessel     function.   "
145801|NCT01375946|"     A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal     delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and     external conditions of heat, humidity, cold water and exercise.   "
145802|NCT01375933|"     The purpose of this study is to assess the comparability of the phase 3 lot and a single     commercial lot of NicVAX in healthy smokers.   "
145846|NCT01375348|"     Patients with chronic pain can experience considerable changes in their cognitive function     such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and     morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead     to worsening of the cognitive function. The interaction between pain, treatment and cognitive     function is very complex and is far from understood.      The hypothesis of the present study is that by use of experimental pain in healthy volunteers     it will be possible to elucidate the interaction between pain, treatment and cognitive     function.   "
145900|NCT01374620|"     The aim of the study is to determine the MTD of Paclitaxel in association with metronomic     Cyclophosphamide.   "
145803|NCT01375920|"     Depression is one of the most common mental health problems, with at least one in six adults     suffering from this at some time in their life. It can become long-lasting and frequently     recurs. Depression has a large negative impact on quality of life of patients and their     carers and it has also been shown to be one of the leading causes of working age adults     receiving disability payments in the UK. The need for improved treatment has been recognised     by the Department of Health and others. Improvements in drug treatments are therefore     required. There has been recent increased understanding of some of the causes of the frequent     lack of complete response seen with antidepressants. The stress hormone, cortisol, is often     elevated or poorly controlled in depression and there is laboratory and clinical research to     show that this hormonal change reduces the benefits from antidepressants with associated poor     outcome and memory problems. Recently it has been shown in small studies that giving     treatments that reduce cortisol or block its harmful effects for between 1 and 3 weeks     overcome these negative consequences. Our group is particularly interested and experienced in     this topic. The investigators plan to study a drug that decreases cortisol levels in people     who have not recovered with standard antidepressants so that the investigators can find out     the usefulness of this treatment (compared with placebo (dummy tablet)) in day to day life as     well as checking closely for side-effects (the initial studies have shown that the particular     drug the investigators wish to study (metyrapone) has few side effects). The investigators     will also measure cortisol and see if its level can tell us which people do best with this     treatment. The investigators will carry out this study in 3 centres across the UK. The     investigators will carry out some additional tests of specific sorts of memory and decision     making and also do this while scanning the brain (in a painless test). The results of these     tests, along with tests of brain wave patterns, should help us understand more fully how this     new treatment is working and who responds best to it. The study will help us find out if this     drug should be used more widely for people not responding to standard treatments and will     also lead on to the development of other new treatments with an anti-cortisol effect to help     tackle the major problem of poor outcome from depression.   "
145804|NCT01375907|"     The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for     Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.   "
145812|NCT01375803|"     This study will critically evaluate the effects of a novel dietary fiber administered to     subjects at high risk for developing diabetes to determine if this intervention will improve     insulin sensitivity compared to control product administration and, thus, decrease risk for     developing diabetes.      The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly     decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic     subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening)     compared to consumption of the control product.   "
145813|NCT01375790|"     This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.      The principal hypothesis is that whole-body vibration training plus exercise improves the     body balance and prevents falls more than only exercise training in institutionalized older     people. The number needed of patients is 160 (80 per group).   "
145805|NCT01375894|"     The ability to understand the other's perspective and respond accordingly is the most     important normal process of daily social life and is probably one of the foundations of human     existence. This capability is reflected, inter alia, as an imitation - an important and     effective form of learning which is very developed in humans. When we are required to imitate     a particular movement, speed of response depends on the perspective of the movement.     Imitative response is implemented faster when the movement is observed from first-person     perspective, than if the motion is presented from the perspective of a third party.      While healthy individuals don't find it difficult to imitate, or to understand the other's     emotion expression, there are psychiatric populations (such as autism and schizophrenia) who     find it difficult to demonstrate these capabilities (Park, Matthews et al. 2008). Beyond     these capabilities impairment, schizophrenic patients have difficulty distinguishing between     their arm movements and those of a foreign hand and find it difficult to leave the boundaries     of egocentric interpretation of reality and adopt the other's point of view. These behavioral     disorders arise from defects in the network of mirror neurons (Buccino and Amore 2008;     Langdon, Coltheart et al. 2010).      Therefore, the investigator expect that schizophrenic patients will not see a preference for     movements that will be displayed in first-person perspective from the same movements that     will be displayed from the perspective of a third party. Consequently, the investigator     speculate that these subjects will not exhibit differences at imitating the response of which     will be presented from different perspectives (Jackson, Meltzoff et (al. 2006.   "
145806|NCT01375881|"     The purpose of this non-interventional study is a description of use of darunavir in daily     practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual     manner and in accordance with the terms of marketing authorization. The assignment of a     patient to a particular therapeutic strategy will not be decided in advance by this study     protocol but instead, it will be part of the current clinical practice. The prescription of     the medicinal product will be clearly separated from the decision to include the patient in     the study. No additional diagnostic or monitoring procedures will be applied to the patients,     and epidemiological methods will be used for the analysis of collected data. After having     agreed with the patient on starting treatment with darunavir, and provided that all inclusion     and exclusion criteria apply, the physician will document the patient's data. Patients will     be observed for at least 48 weeks from baseline visit except for those who withdraw from the     study earlier. Patients data will be collected at approximately 0, 1, 3 and 6 months after     starting treatment and subsequently every 3 months in accordance with routine practice. The     expected number of patients to enroll is about 900. The patients will be treated with     darunavir according to the Italian label. The patient must be withdrawn from the study if the     treatment with darunavir has been stopped. A last evaluation must be documented when     possible, and a resistance test will be collected if available for patients discontinuing for     virologic failure. At the end of study visit, information on therapy given after darunavir     discontinuation will be collected. For patients discontinuing for virologic failure, data     will be collected until the end of the present study, and at least two consecutive     measurements of viral load after starting new antiretroviral therapy will be collected, if     available. All data collected must be the result of the normal medical care of the patient.     The patient's baseline data will be collected within the first week before darunavir     administration (at Visit 1). For patients already in treatment with darunavir, baseline and     follow up data will be collected retrospectively and prospectively. Further data collection     will occur approximately at 1, 3, and 6 months and subsequently about every 3 months     according to routine practice, after initiating darunavir treatment.   "
145807|NCT01375868|"     Vaccines against human papillomaviruses are now commercially available. One of the commercial     vaccine contains antigens of both LR HPV types which cause virtually all cases of RRP.     Clinical trials have documented the safety and immunogenicity of this vaccine as well as its     effectiveness in prevention of incident and persistent infection of the vaccinal types as     well as a development of lesions caused by these types. After vaccination the antibodies     level increases dramatically and the high levels of antibodies are present in the blood still     after 6 years. Furthermore, the neutralization antibodies to the vaccinal antigens have been     detected in the cervical mucus of vaccinated women. The preliminary data are now available     showing the presence of HPV-specific antibodies in the oral cavity in women after     vaccination. The level of antibodies has been dependent on time since vaccination.   "
145847|NCT01375335|"     The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly     intact contraction of the heart. This study aims to elucidate the efficacy of low-dose     dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.   "
145922|NCT01374321|"     Objectives of the phase 2 prospective, multicenter, randomized, double-blind,     placebo-controlled study is to assess safety and efficacy of TRO40303 administered just     before balloon inflation during percutaneous coronary intervention (PCI) for limitation of     infarct size in patients treated for acute myocardial infarction (AMI).      The study is being conducted in 9 centres in Sweden, Denmark, Norway and France. One hundred     eighty patients will be included. It will last one month per patient and its overall duration     will be 11 months.      The efficacy will be assessed by infarct size expressed as area under the curve for creatine     kinase and troponin I (blood sampling at D1, D2 and D3), and also evaluated by Cardiac     Magnetic Resonance.      Safety will be assessed by        -  clinic evaluation,        -  blood samples (hematology, biochemistry, renal and hepatic function),        -  Recording and follow-up of major adverse events occurring during the first 48h after          reperfusion (death, heart failure, AMI, stroke, recurrent ischemia, the need for repeat          revascularization, renal or hepatic, vascular complication and bleeding).        -  ECG        -  Recording cardiac events during one month after AMI        -  Follow-up of global left ventricular function by Echocardiography at D3 and D30.      Demographic and medical history at inclusion and non-cardiac events occurring during the     first 30 days will be recorded. TRO40303 plasma concentration will be assessed at 15 min, 6h,     and 12h post the end of administration.      Sample size calculation assuming a reduction of 35% of the AUC for Troponin I release, for a     statistical power of 85% and a probability of type I error of 0.05.      Main analysis: between-group comparisons of AUCs for serum troponin I and CK release will be     performed using O'Brien's method for multiple endpoints testing.      Secondary analysis: comparisons of the CMR criteria described above will be performed using     mixed model of ANCOVA.      All analyses will be performed on the Full Analysis Set and Per protocol populations.      Safety analysis: A comparison of the incidence of cumulative adverse clinical events between     the groups will be performed by Fisher's exact tests.      Subjects will undergo primary PCI and receive concomitant medications according to current     standard of care.      After coronary angiography is performed but just before balloon inflation is performed,     patients who meet the enrollment criteria will be randomly assigned to either the control     group or the TRO40303 group. Randomization is ensured by taking the treatment units in     ascending and consecutive order in each strata (anterior/posterior as determined on ECG).     Just before balloon inflation, ideally less than 5 minutes, and with a maximum of 15 minutes     before balloon inflation and stenting, the patients in the TRO40303 group will receive an     intravenous slow-bolus (35 mL/min) injection of 6 mg/kg of TRO40303 injected in peripheral     IV. The patients in the control group will receive an equivalent volume of the placebo.     Patients will be hospitalized for as long as there is a medical indication. CMR and     echocardiography will accordingly be conducted as in/out patient between day 3 (ideally) and     5. A follow-up visit will be conducted one month after PCI.   "
145808|NCT01375855|"     Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent     implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion     (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by     means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months     follow-up. The investigators sought to compare the two stent types with the same drug to     verify the polimer role. The polimer itself seems to provoke inflammation and     hypersensibility if the arterial wall and it seems to be the base of a process of positive     remodeling found at drug eluting stent implantation site.      This positive remodeling is the mechanism producing late stent malapposition which on its     turn can determine stent thrombosis, as demonstrated by pathological studies. At the same     time the investigators will study the incidence of clinical events like myocardial     infarction, stent thrombosis, TLR and death along with the incidence of angiographic     restenosis at 2 years follow up.   "
145809|NCT01375842|"     This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate     the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as     single agent to participants with locally advanced or metastatic solid malignancies or     hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort     and Expansion cohort.   "
145810|NCT01375829|"     This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in     treating patients with solid tumors that have spread from the primary site to other places in     the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ixabepilone,     work in different ways to stop the growth of tumor cells, either by killing the cells, by     stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving     ixabepilone together with temsirolimus may kill more tumor cells.   "
145811|NCT01375816|"     RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride     PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways     to stop the growth of tumor cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether giving liposome-encapsulated irinotecan hydrochloride     PEP02 together with leucovorin calcium and fluorouracil is more effective than giving     irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line     therapy in treating patients with metastatic colorectal cancer.      PURPOSE: This randomized phase II trial is studying liposome-encapsulated irinotecan     hydrochloride PEP02 given together with leucovorin calcium and fluorouracil to see how well     it works compared with giving irinotecan hydrochloride together with leucovorin calcium and     fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.   "
145818|NCT01375725|"     The purpose of this study is to measure prothrombin time (PT) expressed in International     Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an     experimental device and a commercially available device. This study will involve taking a     finger-puncture and testing onto a strip and meter system for the experimental and     commercially available devices.   "
145819|NCT01375712|"     The objective of this study is to evaluate if consumption of fermented milk containing     Lactobacillus casei strain Shirota has an impact on stool consistency, stool frequency,     constipation-related symptoms, and quality of life in subjects who frequently have hard or     lumpy stools.   "
145820|NCT01375699|"     Sildenafil increases the therapeutic effect of doxorubicin used as treatment for cancers of     solid tumors through both an increase in anti-tumor effects and protection from cardiac     toxicity.   "
145821|NCT01375686|"     The study will complete up to 500 subjects across 9 clinical sites to evaluate the precision     and accuracy of SCOUT DS (Diabetes Screening) subjects at risk for type 2 diabetes. The study     will involve up to two unique Scout devices at each clinical site. Each site will initially     contain only a CS-1 (Commercial SCOUT 1) A for collection of data. As they become     available, CS-1 Bs operating with latest version of SCOUT software will be shipped to each     site.      The NSEEDS study will enroll patients at-risk for type 2 diabetes who meet the study     inclusion criteria (and do not meet one or more of the exclusion criteria) at approximately 9     clinical sites distributed across the United States. Eligible subjects must be at least 18     years old, not have an existing diagnosis of diabetes and, if less than 45 years old, must     have a body mass index (BMI) ≥ 25 and at least one other risk factor for type 2 diabetes.      The data will be collected and a partial area under the receiver operator curve (pAUC) will     be computed via the method of moments between the 20% and 50% false positive rates based on     the first valid Scout A measurement for each patient. The impaired glucose tolerance status     will be determined by the average of the two hour, post challenge plasma glucose samples     measured at the central laboratory. This will be compared to 1000 bootstrap re-samplings of     the calibration data pulling a cohort that matches that collected during this study. A test     will be conducted to assure that the SCOUT performance lies within a 95% empirical confidence     interval based on the bootstrap re-sampling.   "
145822|NCT01375673|"     Heart Failure (HF) is a significant healthcare concern in the US, with a 120% rise in     mortality rates over 15 years costing the country an estimated $37.2 billion in 2009.     Veterans are currently impacted at a rate of 5.2%, and cost an average of     $14,959/individual/year for those utilizing the VA's Healthcare services. Research has shown     that exercise training (ET) improves aerobic capacity, endothelial dysfunction, quality of     life, and the ability to tolerate activity within the overall HF population. The purpose of     this study is to examine the effects of structured exercise training and specific types of     exercise training, walking, bicycling, and resistance training, on the symptom of fluid     volume over load or edema in advanced heart failure patients.   "
145823|NCT01375660|"     This study will supplement African American male (AAM) veterans at risk for diabetes and     newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps     to improve early markers of diabetes. The study will be done at Veteran Administration     Medical Center in Chicago.   "
145873|NCT01374984|"     This is a post-marketing study to verify the clinical benefits of VIGIV [CNJ-016, Vaccinia     Immune Globulin Intravenous (Human), sterile solution] in the resolution of complications     resulting from smallpox vaccination in eligible patients treated with VIGIV.   "
145824|NCT01375647|"     Oral polio and rotavirus vaccines are significantly less effective in children living in the     developing world. Tropical enteropathy, which is associated with intestinal inflammation,     decreased absorption and increased permeability, may contribute substantially to oral vaccine     failure in developing country settings. Other possible causes of oral vaccine     underperformance include malnutrition, interference with maternal or breastmilk antibodies,     changes in gut microbiota, and genetic susceptibility.      Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral     polio and rotavirus vaccines in children in Bangladesh.      Secondary Objectives: 1) to determine the impact of an inactivated polio vaccine (IPV) boost     on the efficacy of oral polio vaccine and 2) to determine the efficacy of oral rotavirus     vaccine to prevent rotavirus diarrhea      The polio and rotavirus randomized clinical trials are embedded as secondary objectives     within the exploratory study of tropical enteropathy. The primary and secondary outcome     measures are relevant to the randomized clinical trials.   "
145825|NCT01375634|"     Nasogastric tube placement involves insertion of a flexible tube through the nose into the     stomach. Placement of the tube can irritate the nose and palate and trigger gagging, causing     discomfort, even if topical or local anesthetics are used. This study aims to determine if     administration of an ultra-short acting sedative agent (midazolam) into a vein before the     procedure, in addition to topical local anesthetic, will decrease the level of discomfort.   "
145826|NCT01375621|"     Background:      - MRSA is a type of bacteria that causes serious health problems. It can cause severe     infections and is difficult to treat. MRSA has been found in a high number of people who work     with some kinds of livestock, such as pigs. Researchers want to study people in rural areas,     where more people work with or around livestock. They want to see if MRSA is more common or     causes more serious infections in these areas.      Objectives:      - To look at the relationship between livestock handling (especially pigs) and MRSA bacteria     in people in rural areas.      Eligibility:        -  Participants in the Agricultural Health Study in Iowa, including those who are exposed          to livestock.        -  Healthy volunteers who are not exposed to livestock.      Design:        -  This study requires an initial visit and monthly follow-up surveys for 18 months.        -  At the first visit, participants will have throat and nose swabs to collect cell and          bacteria samples. They will also complete a questionnaire about their health habits.          Other questions will ask about any work that brings them into contact with livestock          like cows, pigs, or chickens.        -  Every month for the next 17 months, participants will complete another questionnaire to          record any changes in their health and livestock contact information. They will also          collect throat and nose swabs. They will send the questionnaires and the swabs to the          study researchers.        -  Participants will be paid for the first visit and for every monthly survey and swab          collection they return.        -  No treatment will be given as part of this protocol.   "
146088|NCT01372124|"     This is a multi center, open label, parallel group, single administration, phase I trial, in     subjects with mild, moderate or severe renal impairment and a control group with normal renal     function.   "
145827|NCT01375608|"     Background:        -  In sickle cell disease (SCD), the proteins in the red blood cells that carry oxygen do          not behave normally. In parts of the body where there are low levels of oxygen or where          oxygen is used more, the sickle hemoglobin proteins may change shape and stick together.          This causes the red cells to clump, which reduces blood flow. This leads to even lower          oxygen levels and causes damage and/or pain.        -  One way to stop the red blood cells from sticking together is to increase the levels of          fetal (baby or good ) hemoglobin. The good hemoglobin then takes the place of the sickle          hemoglobin.        -  Hydroxyurea is the only approved drug for SCD. But hydroxyurea works in only about          two-thirds of people with SCD. Even in those cases it sometimes stops working over time.        -  Researchers are interested in testing decitabine. The drug may help to increase fetal          hemoglobin levels. But it has not yet been approved to treat SCD.      Objectives:      - To test the safety and effectiveness of decitabine in increasing fetal hemoglobin levels     and improving the symptoms of sickle cell disease.      Eligibility:      - People at least 18 years of age who have sickle cell disease that has not improved after at     least 6 months of hydroxyurea therapy. Those who cannot take hydroxyurea because of side     effects may also participate.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood and urine tests, a lung function test, and other tests as required.        -  Participants will receive decitabine injections up to twice a week for 1 year. Depending          on the response to treatments, the dose will remain the same or be reduced to once a          week.        -  Participants will be monitored with frequent blood tests and other studies as directed          by the study doctors.        -  After the study is completed, participants will go back to their usual sickle cell care.          If decitabine has improved a participant's SCD, treatment may be continued under regular          health coverage insurance if this can be arranged.   "
145828|NCT01375595|"     Background:      - Studies have shown that animals such as monkeys and dogs have excellent sight and touch     memory but perform poorly on sound memory tasks. Human brains have certain areas that are     important for speaking and understanding language. These areas may be involved in sound and     spoken word memory. Researchers want to study these areas of the brain to find out if the     memory for sounds requires brain structures that are usually associated with language     learning and are unique to humans.      Objectives:      - To use magnetic resonance imaging to study areas of the brain involved in sound memory.      Eligibility:      - Healthy right-handed volunteers between 18 and 50 years of age. They must be native English     speakers and have completed high school.      Design:        -  The study requires a screening visit and 1 or 2 study visits to the National Institutes          of Health Clinical Center.        -  At the screening visit, volunteers will have a medical history taken. They will also          have physical and neurological exams, and complete a questionnaire. Women of          childbearing age will give a urine sample. Participants who have not had a magnetic          resonance imaging (MRI) scan in the past year will have one at this visit.        -  At the second visit, participants will have tests of sound memory. They will listen to a          set of nonsense words spoken through earphones and memorize the words. Then they will          listen to the words again to judge if the words were part of the earlier list.          Participants will have a 1 hour break, then do the sound memory test again. During the          second test they will have repetitive transcranial magnetic stimulation (rTMS), which          stimulates different regions of the brain.        -  If the group results from the testing sessions are positive, there will be a third          visit. At this visit, participants will have a sound perception test. They will listen          to words spoken through earphones and judge whether the words in the pair are the same          or different. Participants will have rTMS during these tests as well.   "
145829|NCT01375582|"     This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.   "
145874|NCT01374971|"     The purpose of this study is to conduct an Investigator-Sponsored Study to determine the     potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of     disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre     treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.   "
145875|NCT01374945|"     Use of Clearpath to facilitate successful completion of colonoscopy procedures with     sub-optimal preparation.   "
145923|NCT01374308|"     The general objective of the present clinical trial is to compare the therapeutic efficacy of     a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and     hepatitis B core antigen (HBcAg) [later called NASVAC] with a commonly used antiviral drug,     pegylated interferon in patients with chronic hepatitis B (CHB).   "
145830|NCT01375569|"     Background:      - TRC105 is an experimental cancer drug. It is designed to slow or stop the growth of tumors.     It does this by preventing the growth of new blood vessels that feed these tumors. People     with hepatocellular carcinoma (or liver cancer) sometimes do not respond to standard     treatments. This includes the cancer drug sorafenib.      Objectives:      - To test the safety and effectiveness of TRC105 to treat liver cancer that has not responded     to standard therapy.      Eligibility:        -  People at least 18 years of age who have hepatocellular carcinoma (or liver cancer) that          has not responded to standard therapy. Participants also will not be eligible for a          liver transplant.        -  No anticoagulation therapy is allowed with the exception of low-dose aspirin.        -  No history of bleeding disorders, peptic ulcer disease or gastritis.      Design:        -  Participants will have a physical exam and medical history. They will also have blood          and urine tests, and imaging studies.        -  Participants will receive TRC105 once a week. They will also have two daily doses of a          steroid the day before each treatment. This will help prevent known side effects.        -  Participants will be monitored with blood and urine tests. They will also have imaging          studies every two months to study the effect of the drug on tumor growth.        -  Participants will continue to have TRC105 as long as they do not have severe side          effects and their liver cancer stops growing or shrinks. After stopping TRC105, they          will have yearly visits with physical exams and blood tests.   "
145831|NCT01375556|"     Background:      - Previous research has shown that a person s genes can influence how they respond to     alcohol. But researchers do not yet know all the genes that might be involved.      Objectives:      - To identify genes that are related to how non-alcoholic individuals respond to alcohol.      Eligibility:      - Healthy people between 21 and 30 years of age who have no history of alcohol or drug     dependence.      Design:        -  The study requires one or two 9-hour visits to the National Institutes of Health          Clinical Center.        -  Participants must not take any medicines (except birth-control pills for women) for at          least 3 days before the visit. They must not drink alcohol for at least 2 days before          the visit.        -  Screening includes a medical history, physical exam, and a urine test for drugs of          abuse.        -  Participants will be given alcohol over about 2.5 hours. This will have about the same          effect as having three to four drinks. Frequent breathalyzer tests will check breath          alcohol level during the infusion.        -  Before and during the infusion, participants will complete questionnaires about mood and          feelings. Other tests will study thinking, balance, judgment, and risk-taking. Blood          samples will be collected four times during the infusion.        -  Participants will have breakfast at the start of the visit (around 8:00 AM). They will          have a snack before the start of the alcohol infusion (around 10:45 AM). Lunch will be          served after the alcohol infusion is complete (around 2:20 PM). After the tests, those          in the study will have to stay in the Clinical Center until their breath alcohol level          falls below 0.02%. This can take up to 2.5 hours. A final blood sample will be drawn at          that time. Participants will not be able to drive themselves home after the study          visits. Also, they should not take any medicines or operate any machinery for at least 2          hours after leaving NIH.   "
145832|NCT01375543|"     Background:      - The purpose of this study is to identify changes in genes that cause human diseases. We     would like to obtain some of you or your child s DNA and test for changes in genes that may     contribute to a disease in you or your family.      Objective:      -To allow for exomic or genomic sequencing of NICHD patients or family members in order to     identify changes in genes that cause or contribute to a specific disease.      Eligibility:        -  Children who are enrolled in an NICHD clinical study where the condition being studied          may have a genetic cause.        -  Family members of a child who is eligible for this study.      Design:        -  Children and family members will supply DNA samples. If the samples are already          available, no further DNA will be needed.        -  If DNA is not available, samples of either blood or skin will be taken.        -  We will use these samples with new DNA sequencing technology that looks at all the human          genes we know about. This is known as exome and genome sequencing.   "
145864|NCT01375101|"     Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic     etiology ,which has number of different clinical forms. Alternative natural or herbal origine     drugs with antioxidant and anti-inflammatory properties have been used individually or in     combination with systemic corticosteroids in order to decrease adverse drug reactions.      This study was conducted to evaluate the effect of quercetin on treatment of erosive     -atrophic lesions of oral lichen planus (OLP).   "
145865|NCT01375088|"     The purpose of this study is to determine whether propolis is effective in the treatment and     prevention of radiotherapy induced oral mucositis.   "
145833|NCT01375530|"     Background:      - The National Institute of Allergy and Infectious Diseases (NIAID) at the National     Institutes of Health needs healthy volunteers for vaccine clinical trials. These trials will     allow researchers to study vaccines and injection devices. These studies will also allow     researchers to understand the immune system and how vaccines work. In this protocol,     researchers will screen healthy volunteers for these future trials.      Objectives:      - To screen healthy volunteers for clinical trials at the NIAID.      Eligibility:      - Healthy people between 18 and 70 years of age. They must be available to take part in     clinical trials and be able to provide blood for research studies.      Design:        -  Screening for a clinical trial may begin several months before the vaccine clinical          trial begins.        -  Volunteers will be screened with a physical exam and medical history. They may also          answer questions about sexual activity and drug use.        -  Volunteers will provide blood samples and possibly urine samples. They may have other          tests as needed for the study.        -  Volunteers will not receive any treatment in this screening trial.   "
145834|NCT01375504|"     This study is designed to assess the effect of a mindfulness training program with special     focus on diet and nutrition vs. dietary counseling in 40 obese adults (BMI range 30-40) and     their partner/spouses (irrespective of their BMI), in a 6-month pilot randomized controlled     trial.   "
145835|NCT01375491|"     Obesity is a heightened state of inflammation in which production of cytokines and matrix     metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin     resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance     insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes     (DM2).   "
145836|NCT01375478|"     This open-label, retrospective, observational study will evaluate the compliance to     RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid     arthritis. Six months data will be collected from patients records.   "
145837|NCT01375465|"     The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary     intervention (PCI) to assess the clinical success, efficacy and safety of the     Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial     bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the     stenotic site branch.   "
145839|NCT01375439|"     Introduction: Preterm labor (PTL) is an important obstetric intercurrence that affects 5 to     10% of pregnancies. Among the known factors of PTL etiology are PTL occurrence in previous     pregnancies, multiple pregnancies, polyhydramnios, vaginal bleeding during pregnancy,     premature membrane rupture (PMR) and bacterial vaginosis. Despite the advancement achieved in     Neonatology, morbidity and mortality resulting from high rates of preterm births have     remained constant in the last few decades. Objective: This study aims at evaluating maternal     and perinatal outcomes of pregnant women with a history of preterm labor in previous     pregnancies and submitted to active search for vaginal infection. Material and Method: It is     a prospective-cohort epidemiological study to be conducted in Botucatu/SP. Two study groups     (G1 and G2) will be formed, and each of them will comprise 140 pregnant women with a history     of preterm childbirth. G1 will be related to the active search and etiological diagnosis of     lower genital tract infections, and G2 will be related to non-search for such infections, for     which the routine care protocol of primary health units in the city of Botucatu will be     maintained. Care propedeutics for the pregnant women (G1) will include the performance of     direct examination of vaginal content stained by the Gram method, culture in Diamonds medium,     polymerase chain reaction (PCR) of endocervical secretion collected in the primary health     care services in the city at two moments: prior to the 20th gestational week (M1) and at the     36th week (M2). Moment M3 will take place after childbirth for evaluation of the perinatal     outcome.   "
145840|NCT01375426|"     Over a period of years there have been numerous reports from many developing countries     including Pakistan showing a rising treatment failure rate with first line drugs (amoxicillin     and cotrimoxazole) in non-severe pneumonia in children. The reasons for this rise in     treatment failure rates are not entirely clear but one of the reasons is thought to be     increasing antimicrobial resistance of H. influenzae and Strep. pneumoniae to first line     drugs. There is microbiological data which suggests that this resistance can be overcome by     increasing the dose of amoxicillin. The investigators propose to treat non-severe pneumonia     with double dose amoxicillin in an attempt to demonstrate a decrease in treatment failure     rates. This will be a multicentre, double blind randomized controlled trial in children 2-59     months of age with non-severe pneumonia comparing the clinical outcome between the standard     and double dose groups.      It has been felt that the WHO criteria for treatment failure in children with pneumonia are     too stringent and have never been systematically evaluated in the community. The     investigators also propose to modify WHO criteria and field test them in this trial in an     attempt to demonstrate that less stringent treatment failure criteria would have an impact on     the overall treatment failure rates in pneumonia.      Hypothesis:      Therapy outcome with double dose of oral amoxicillin is not different than the standard dose     of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59     months old children.   "
145866|NCT01375075|"     The purpose of this study is to determine if 12 weeks of treatment with LY2484595     administered as a monotherapy will significantly increase high-density lipoprotein     cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) in Japanese     participants.   "
145867|NCT01375062|"     The purpose of this study is to isolate and culture stem cell from adult human testicular     biopsies for future transplantation in fertility preservation.   "
145933|NCT01373632|"     Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating     patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW     Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical     trials. Here the investigators design a prospective, multicenter, randomized clinical study     in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD     patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel     SES.   "
145841|NCT01375413|"     The ability to perform two or more tasks together is impaired in Parkinson's Disease (PD).     Based on pilot work we hypothesize that dual tasking is amenable to training in PD and will     not compromise safety. In the proposed study we will therefore collect high level evidence on     whether 6 weeks of integrated dual task gait training is more effective than consecutive task     practice. The investigators will use a randomized, single blind study design and conduct the     same protocols in two academic centers (Katholieke Universiteit Leuven and Radboud     Universiteit Nijmegen). The investigators intend to test an experimental condition which     consists of focused dual task training in the home using a novel program of personalized     cognitive tasks. The aim of dual task training is to teach motor-cognitive task integration     and achieve optimal levels of automaticity and functionality. The control arm will receive     gait practice and separate cognitive training of the same intensity, but offered     consecutively. We will test the hypothesis that dual task training (integration) will have     more pronounced effects on complex gait than consecutive task training.      Sub-analysis will be conducted on patients with and without freezing of gait. The     investigators expect that integrated dual task training may be less effective in patients     with freezing, due to the increased fall risk and impaired cognitive profiles.      Overall, this project will provide evidence to support future directions for motor learning     and innovative rehabilitation targets.   "
145842|NCT01375400|"     Aspirin is the only anti-platelet medication used at the acute phase of ischemic stroke. The     investigators would like to study laboratory effect of the first oral 300 mg dose of aspirin,     given at hospital, after an ischemic event.      The principal hypothesis is that platelet activity would be able to recover during this day     and could lead to ischemic recurrences.      Two blood samples are accomplished. The first 2 hours after aspirin intake and the second 23     hours after. Photometric aggregometry are performed with arachidonic acid and collagen     induced platelet aggregation, measure of thromboxan B2 levels and reticular platelets count.   "
145843|NCT01375387|"     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of     lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in     healthy male Chinese and Japanese subjects.   "
145844|NCT01375374|"     The purpose of the trial is to investigate whether changes in lipids and hormonal parameters     can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment,     while Levetiracetam treatment remains unchanged.   "
145845|NCT01375361|"     This is a randomized trial of the use of Albuterol in the setting of acute decompensated     Congestive Heart Failure with radiographic evidence of Cardiogenic Pulmonary Edema.   "
145848|NCT01375322|"     The purpose of the study is to compare the change from baseline in blood pressures (DBP/SBP)     to 16-week regimen between Amtrel® and Co-Diovan®. The secondary objectives were listed as     the following.        -  To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of          study        -  To evaluate the change from baseline in albumin-to-creatinine ratio with          antihypertensive medications in whole group (combined treatment groups) and each          treatment group (Amtrel®, Co-Diovan®) at Week 16        -  The change from baseline in glycosylated hemoglobin (HbA1c) at Week 16        -  The change from baseline in fasting plasma glucose (FPG) at Week 16        -  The change from baseline in fasting lipid profiles (triglyceride, total cholesterol,          high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at Week 16        -  The change from baseline in arteriosclerosis marker (brachial-ankle pulse-wave velocity          (ba-PWV) and ankle-brachial pressure index (ABI), using Colin-VP1000) at Week 16        -  The change from baseline on the body mass index (BMI) and waist-hip ratio (WHR) at each          specified study time point        -  To ascertain the safety and tolerability of Amtrel® versus Co-Diovan® including AE/SAE,          and laboratory examinations   "
145849|NCT01375309|"     Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal     intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm     infants who received Bifidobacterium bifidum early after birth. In order to evaluate these     beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is     conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to     preterm infants improve enteral feeding and growth in very low birth weight infants.   "
145850|NCT01375296|"     Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with     significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary     syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and     the effect of SES in these patients remains unclear. Here the investigators hypothesize that     application of China-made SES may improve the clinical outcomes in these setting.   "
145851|NCT01375283|"     This is a prospective observational cohort study on changes in sensory mapping.   "
145852|NCT01375270|"     Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory     function of the pancreas. This is known as glucolipotoxicity. However, few studies have     examined this in detail. This investigation will examine pancreatic insulin secretory     function in physiological models of glucolipotoxicity such as obese and type 2 diabetic     individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or     Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response     to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal     ingestion, will be examined. the investigators hypothesize that experimental     glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that     seen in type 2 diabetics.   "
145853|NCT01375257|"     Background Current management of infective endocarditis include admission and treatment with     parenteral antibiotics for 4 weeks - 6 weeks. Resource demands and psychological issues of     present management strategy make it highly relevant to seek for alternative more lenient     alternatives. Experiences with oral treatment are only sporadically described, but     observational data suggest that oral treatment could be a feasible option. The investigators     have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100%     success rate.      Study design The POET study is a Danish multicenter, prospective, randomized, open label     study. The primary aim is to show non-inferiority of partial oral treatment with antibiotics     of endocarditis compared to full parenteral treatment. Stable patients (n=400) with     streptococci, staphylococci or enterococci infecting the mitral valve or the aortic valve     will be included. After a minimum of 10 days of parenteral treatment, patients will be     randomized to oral therapy or parenteral therapy. Special recommendations for oral treatment     have been developed based on expected minimal inhibitory concentrations and pharmacokinetic     calculations. Patients will be followed for 6 months after completion of antibiotic therapy.     The primary endpoint is a composition of all cause mortality, unplanned cardiac surgery,     embolic events and relapse of positive blood cultures with the primary pathogen.   "
145854|NCT01375244|"     The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets     and IPR Pharmaceuticals, Inc. Zestril (R).   "
145855|NCT01375231|"     The investigators posit that it would be advantageous to reproduce the height of the entire     patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its     preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient.     For example the quadriceps mechanism would have to work harder if the total patellofemoral     (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may     occur if the overall PF height is increased. The investigators theorize that either of these     sizing errors could lead to anterior knee pain. The purpose of this study is to compare the     clinical outcomes between two surgical techniques: 1) a technique of reproducing the total PF     joint on both sides of the articulation (Group 1) and 2) the traditional technique of     reproducing only the patellar thickness on one side of the joint (Group 2).   "
145856|NCT01375218|"     The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction     brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip     (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and     the Pavlik harness. The investigators hope to learn which brace treatment is best for a     definable population so the appropriate brace can be chosen initially avoiding the time,     expense, and frustration of a failed technique.   "
145857|NCT01375205|"     The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on     babies' skin versus Johnson & Johnson baby lotion and skin cleanser.   "
145858|NCT01375179|"     This study is designed as a proof of concept of KRP203 for induction of remission in     ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203     in subjects with moderately active refractory ulcerative colitis.      The study will provide safety and tolerability data in this subject population up to eight     weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a     clinical response to KRP203 by following up responding subjects for an additional 12 weeks.   "
145859|NCT01375166|"     The prevalence of diabetes is increasing and the management of the disease is nowadays     considered a major challenge. Affected patients have increased mortality and morbidity as     well as a significant drop in the quality of life. The complications of diabetes can be     classified as microvascular (e.g. nephropathy, neuropathy or retinopathy) or macrovascular     (e.g. cardiovascular or cerebrovascular).      Several large-scale epidemiologic studies indicating that wider retinal venous caliber is     strongly associated with the fasting glucose level as well as with diabetes. Another retinal     vascular abnormality that is associated with diabetes is an abnormal retinal vascular     response to flicker stimulation. Retinal vessel dilatation in response to stimulation with     diffuse flicker light occurs due to a phenomenon called neurovascular coupling. This means     that increased activity of neurons is associated with an increased retinal metabolism. This     leads to a release of endogenous vasodilator substances and increased blood flow. However,     previous studies were limited by the fact that retinal vessel diameters and blood flow were     not measured simultaneously.      The present study aims to investigate whether the response of retinal vessel diameters and     blood flow velocities to flicker stimulation is altered in patients with diabetes. Both     parameters will be measured in real time using Fourier Domain Doppler OCT.   "
145860|NCT01375153|"     Chronic heart failure is accompanied by anorexia and increased release of B-type natriuretic     peptide (BNP) from the ventricular myocytes. The pathophysiological mechanisms linking heart     failure and appetite-regulation remain unknown. This study aims to examine the impact of     exogenous BNP administration on subjective ratings of hunger and satiety, and on     appetite-regulating hormones in a placebo-controlled cross-over study performed in ten     healthy human volunteers.   "
145861|NCT01375140|"     The goal of this clinical research study is to learn if the combination of ruxolitinib and     lenalidomide can help to control MF. The safety of this study drug combination will also be     studied.      Ruxolitinib is designed to stop certain proteins (called JAK1 and JAK2) that are found in MF     cells from sending signals that may lead to the growth of cancer cells.      Lenalidomide is designed to change the body's immune system. It may also interfere with the     development of tiny blood vessels that help support tumor growth. This may decrease the     growth of cancer cells.   "
145862|NCT01375127|"     This is an observational study designed to collect follow-up clinical date on subjects who     were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued     treatment prematurely or did not elect to enroll in long-term extension studies.   "
145863|NCT01375114|"     The goal of this clinical research study is to learn if panax ginseng (commonly called     ginseng) can help to control fatigue and other symptoms such as depression, anxiety, and mood     changes in patients with cancer. The safety of ginseng will also be studied.   "
145934|NCT01373619|"     Heart failure with normal ejection fraction is often under diagnosed and certainly under     treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine,     a pure heart-rate lowering agent without effects on blood pressure, is of potential     therapeutic utility.   "
145868|NCT01375049|"     This is an open-label, multi-center study in pediatric patients age 3 months to less than 18     years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary     colonization/infection. All eligible participants will be treated with a 28-day course of     Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug,     subjects will be followed up through Day 196 for safety and recurrence of PA.      The primary objective is to evaluate the proportion of participants with PA-negative cultures     at all time points during a 6-month monitoring period (through Day 196) after cessation of     AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI     treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after     completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).   "
145869|NCT01375036|"     This is a prospective, longitudinal, 5-year study that will enroll participants from the     existing Cystic Fibrosis Foundation (CFF) patient registry. Each enrolled participant will     provide samples for microbiological evaluation, obtained upon enrollment and then once per     year thereafter for 5 years.   "
145870|NCT01375023|"     The purpose of this study is to evaluate the engraftment, toxicity and anti-tumour activity     of allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG     conditioning regimen in patients with refractory Triple Negative breast cancer.   "
145871|NCT01375010|"     The purpose of this study is to determine the effects of vitamin D on measures of bone health     and immune function in HIV infected postmenopausal women. The investigators prior research     with this population revealed that low vitamin D levels are very common. Prior research with     this population also revealed that Vitamin D is necessary for the body to absorb calcium and     is important for the health of the bones. When vitamin D levels are low, there are increased     risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also     been associated with impaired immune function. This study will help us learn whether two     different doses of vitamin D will improve bone health and immune function.   "
145872|NCT01374997|"     Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called     alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function     properly. As a result, the lipid accumulates in the body, this leads to multisystem     impairment, including progressive renal failure.      Several studies have focused on the detection of this disease in end-stage renal failure     patients, transplant or hemodialysis.      This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a     glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90     and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine     level greater than 0,5 g/l.      This screening will be conducted by a blood test to measure the level of alpha-galactosidase     A activity by micromethod from samples taken from blood spots on filter paper. If this assay     was positive, confirmation of diagnosis of Fabry disease will done the standard method:     macrodosage of leukocytic alpha-galactosidase A activity.      This multicenter prospective study, openly contacted in medical practice, with patient     follow-up corresponding to the management of renal insufficiency, will be offered to all     departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.      The objective of this study is to assess the prevalence of Fabry disease in the target     population and to identify previously undiagnosed patients, enabling them to benefit from     appropriate management of their disease, including whether need enzyme replacement therapy.   "
145876|NCT01374932|"     The CPASMA trial is a descriptive, prospective, multicentre clinical trial, with a     before/after Continuous Positive Airway Pressure (CPAP) assessment in participating patients.     It aims to answer the following question: Is there an improvement in asthma in those patients     with both asthma and obstructive sleep apnoea syndrome (OSAS) treated with CPAP after six     months?. It is hypothesized that treatment of OSAS with CPAP in patients with both OSAS and     asthma concommitantly, may have a beneficial effect also on asthma outcomes. This clinical     effect in asthma could be assessed objectively by applying validated questionnaires for     quality of life and asthma control.   "
145877|NCT01374919|"     The aim of the study is to recruit 30 patients who have been referred to Auerach Hematology     Oncology Assoc. for the treatment of iron defeciency anemia with iv iron (Ferumoxytol 1020     mg) administered via infusion pump over 15 minutes.      To ascertain acute safety and tolerability of ferumoxytol during immediate post dosing     observation period.      Assess additional safety profile and laboratory assessment at follow up visit and interim     telephone follow up.   "
145878|NCT01374906|"     This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and     efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with     Cushing's disease.   "
145892|NCT01374724|"     The prevalence of tobacco use in the military is too high. This study is designed to take     advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and     develop effective interventions to prevent tobacco relapse.      Hypotheses or Research Questions:        -  Are there differences in the rate of relapse between three groups participating in a          tobacco abstinence maintenance intervention?        -  Do the tobacco abstinence maintenance interventions delay relapse?   "
145935|NCT01373606|"     This is an open-label, multi-center study, investigating the efficacy and safety of     terlipressin in Japanese patients with hepatorenal syndrome type 1.   "
145936|NCT01373593|"     In this controlled study the investigators will examine the analgesic and sensory effects of     ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in     persistent postherniorrhaphy pain patients.   "
145879|NCT01374893|"     Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to     assess the effectiveness of an intrahospital strength and walk program during short hospital     stays for improving functional capacity of patients aged 75 years or older.      Methods Patients aged 75 years or older admitted for a short hospital stay (≤14 days) will be     randomly assigned to either a usual care (control) group or an intervention (training) group.     Participants allocated in the usual care group will receive normal hospital care and     participants allocated in the intervention group will perform multiple sessions per day of     lower limb strength training (standing from a seated position) and walking (10 min bouts)     while hospitalized. The Primary outcome to be assessed pre and post of the hospital stay will     be functional capacity, using the Short Physical Performance Battery (SPPB), and time to walk     10 meters. Besides length of hospitalization, the secondary outcomes that will also be     assessed at hospital admission and discharge will be pulmonary ventilation (forced expiratory     volume in one second, FEV1) and peripheral oxygen saturation. The secondary outcomes that     will be assessed by telephone interview three months after discharge will be mortality,     number of falls since discharge, and ability to cope with activities of daily living (ADLs,     using the Katz ADL score and Barthel ADL index).      Results Results will help to better understand the potential of regular physical activity     during a short hospital stay for improving functional capacity in old patients.      Conclusions The increase in life expectancy has resulted in a large segment of the population     being over 75 years of age and an increase in hospitalization of this same age group. This     calls attention to health care systems and public health policymakers to focus on promoting     methods to improve functional capacity of this population.   "
145880|NCT01374880|"     The objective of this work is to investigate and then to sequence new biomarkers in the     plasma of patients presenting with dyspnea secondary or not to heart failure, and study their     diagnostic and prognostic value.   "
145881|NCT01374867|"     The aim of CardShock Study is to recognise significant prognostic factors in order to detect     patients with increased mortality risk to which one could possibly direct more intensive     treatments.      The study will provide clinical, functional and invasive haemodynamic measures with     systematic serial sampling and evaluation. In addition, the knowledge on the pathophysiology     of cardiogenic shock is increased.   "
145882|NCT01374854|"     Umbilical mesenchymal stem cells (UC-MSCs) infusion is supposed be a promising regeneration     therapy with mild side effect as indicated by large quantities of animal experiments and some     clinical trials. There are few UC-MSCs clinical trials with regard to diabetes mellitus. The     investigators hypothesize that infusion of USC-MSCs may provide multiple signals for     beta-cell regeneration and even re-differentiate into local tissues in diabetes mellitus     patients, resulting in improvement of diabetic control, of which the effect may be promoted     by concomitant infusion of bone marrow mononuclear cells and maximized by intra-arterial     pancreatic infusion through angiography.   "
145883|NCT01374841|"     The purpose of this study is to determine if engraftment can be achieved safely in patients     with high-risk hematologic malignancies who undergo non-myeloablative transplant with     peripheral stem cells from Human Leukocyte Antigen (HLA) haploidentical donors with pre and     post-transplant cyclophosphamide as immunosuppression.   "
145884|NCT01374828|"     Pain control following surgery is a critical aspect of patient care. Pain at incision sites     in laparoscopic surgery contributes to overall pain felt by a patient. There is no definitive     proof that the typical medications (such as lidocaine) injected at incision sites during     surgery improve pain control. This study looks at a different type of medication (ketorolac -     an NSAID) to better control pain at laparoscopic incision sites.   "
145896|NCT01374672|"     This research study is studying biomarkers in predicting response to chemotherapy in samples     from young patients with osteosarcoma. Studying samples of tumor tissue from patients with     cancer in the laboratory may help doctors learn more about changes that occur in DNA and     identify biomarkers related to cancer. It may also help doctors predict how patients will     respond to treatment.   "
145897|NCT01374659|"     Several studies have indicated that [124I]-PET/CT or [18F]-FDG-PET/CT may be useful to locate     recurrent differentiated thyroid carcinoma lesions in patients with elevated thyroglobulin     levels but who do not show pathological lesions when conventional imaging modalities are     used. Thus, the investigators evaluated the effectiveness of PET/CT using both [124I] and     [18F]-FDG in such patients.   "
145898|NCT01374646|"     This study will evaluate the effectiveness of a comprehensive community based program on     reducing excess weight in children and teens. This study will recruit 150 participants     between the ages of 6-12 and 13-17.   "
146400|NCT01368042|"     The purpose of this study is to assess health-related Quality of Life (QoL) changes in     participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT)     undergoing hemodialysis and receiving paricalcitol intravenous (iv).   "
145885|NCT01374815|"     In this study, the investigators will be using The Online Advocate, a Web-based     health-related social problems screening and referral tool, to explore the relationship     between health-related social problems and children's diet quality among families with young     children attending the Children's Hospital Primary Care Center. The Online Advocate consists     of a 60-80 question screening survey for health-related social problems (such as food     insecurity, employment and income, homelessness) and allows participants to select referrals     for local health and social service agencies that might help them with the problems     identified through the survey. Layered into The Online Advocate for this study is an     adaptation of the Harvard Service Food Frequency Questionnaire (HSFFQ) that can assess     children's diet quality. The investigators plan to recruit 350 parent/guardians of otherwise     healthy children age 3-10 years who are presenting to the primary care center for routine     well child care. Eligible parent/guardians will have the opportunity to take The Online     Advocate (plus HSFFQ) on a laptop computer in the waiting area before seeing their     pediatrician or healthcare provider. Participants will receive a small incentive for their     time as well as written information on healthy nutrition and an age appropriate coloring book     for the child. At one month, participants will be contacted by the study team by email or     phone and asked follow up questions about the status of their health-related social problems     identified through The Online Advocate and whether the referrals they received were helpful.     Participants will receive a small incentive for their time, along with a reminder message     promoting healthy nutrition for their child. At three months, participants will be contacted     by the study team by email or phone and asked follow up questions about the status of their     health-related social problems identified through The Online Advocate and whether the     referrals they received were helpful. They will also re-take the adapted HSFFQ. Participants     will receive another small incentive for their time. Participants will also have the     opportunity to re-take The Online Advocate at three months, though this is optional. The     investigators believe this pilot study will provide foundational knowledge about the     intersection between health-related social problems and children's diet quality and may     inform future research studies and interventions.      Our Study Aims are:        1. To use The Online Advocate to evaluate the association between health-related social          problems and diet quality in children in a cross-sectional sample.        2. To evaluate the relationship between resolution of health-related social problems using          The Online Advocate and change in diet quality in children over a 3 month period.      Our Study Hypotheses are:        1. A greater number of health-related social problems per family will be associated with          poorer diet quality in children at baseline.        2. After 3 months, families demonstrating resolution of one or more health-related social          problems addressed with The Online Advocate will demonstrate greater improvement in diet          quality in children.   "
145886|NCT01374802|"     The objective of the current study is to investigate the effect of multiple oral daily doses     of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with     ritonavir.   "
145887|NCT01374789|"     The primary objective of the study is to assess the efficacy of the combination consisting of     gemcitabine/cisplatin and panitumumab in patients with urothelial carcinoma and wild-type     HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared     to expectations derived from historical data, which are verified by a randomised control     group without the antibody.   "
145888|NCT01374776|"     Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/     kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic     premenopausal women with iron deficiency on      Primary objective:      - Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of     the lower leg muscle)      Secondary objectives:        -  Maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at          submaximal power during a constant-load cycling exercise test        -  Plantarflexor muscle fatiguability as assessed by isokinetic dynamometry        -  Trial with medicinal product   "
145889|NCT01374763|"     The aim of the study is to describe the effects of oxycodone/naloxone combination in     comparison to oxycodone for the treatment of postoperative pain in patients undergoing     cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and     the need of laxatives will decrease.   "
145890|NCT01374750|"     The purpose of this study is to evaluate the anti-tumor effect of sirolimus-based     immunosuppressive regimen in patients following living donor liver transplantation for     hepatocellular carcinoma exceeding Milan criteria with respect to recurrence-free survival.   "
145891|NCT01374737|"     There are several recommended doses of dexmedetomidine for prevention of emergence agitation     in children. In this study, the investigators examine ED50 in prevention of emergence     agitation after tonsillectomy or adenoidectomy in children.   "
145893|NCT01374711|"     The human body knows a biphasic immunological reaction to sepsis. First, the pro-inflammatory     reaction takes place, marked by the release of pro-inflammatory cytokines like TNF-α, as a     reaction to the bacterial toxins. Secondly, the counter regulatory anti-inflammatory reaction     arises. This phase is acting as negative feedback on the inflammation by inhibition of the     pro-inflammatory cytokines. This is called immunoparalysis, a pronounced immunosuppressive     state, which renders patients vulnerable to opportunistic infections. Most of the septic     patients survive the initial pro-inflammatory phase, but die during this second     stage.Research in the past has shown that immunostimulatory therapy with GM-CSF or IFN-γ has     promising effects on the pro-inflammatory reaction during immunoparalysis ex vivo. Both drugs     are known for their immunostimulatory effects. Recent pilot studies have showed in septic     patients, that long-lasting monocyte deactivation in sepsis ex vivo can be reversed by these     two immunostimulants. However, the mechanism and extent of immunoparalysis recovery may be     different between the two compounds. Previously it has been shown that human endotoxemia     (induced by LPS), leads to marked immunosuppression in healthy individuals, characterized by     a transient refractory state to a subsequent LPS challenge (endotoxin tolerance).     Consequently, human endotoxemia can serve as a standardized, controlled model for     sepsis-induced immunoparalysis. Until now, all studies have focused on the ex vivo tolerance.     However, we have recently proved, that the ex vivo condition is not completely representative     for the in vivo situation. Ex vivo, leukocyte tolerance to LPS resolves within one day, while     the in vivo immunoparalysis persists for two weeks. In this project, we will investigate the     effects of both GM-CSF and IFN-γ in a parallel double-blind placebo controlled randomized     manner on the immunoparalysis following human endotoxemia, both in-vitro and in vivo. As a     result, we hope to get more insight in the pathophysiology of sepsis-induced immunoparalysis     and thereby develop new immunostimulatory therapies that improve patient outcome   "
145894|NCT01374698|"     This is a prospective, randomized study conducted in patients undergoing coronary     revascularization procedures (PCI) through angioplasty. All patients who meet the eligibility     criteria will be randomized to receive, before the procedure, an oral aspirin reload (325 mg)     and to be re-evaluated at 60 minutes, 120 minutes, 6 hours, 48 hours, 5 and 30 day, 3 and 6     months.   "
145895|NCT01374685|"     Background:      - Certain genetic mutations are linked to higher rates of cancer. It is important for people     with these mutations to tell their families about it. This is because others in the family     may also be at greater risk for developing these cancers. They can also pass these genes to     their own children. But not much is known about how African Americans tell their family     members about the results of their genetic testing. The information from this study can be     used to improve genetic counseling services. These services will then be more effective in     early cancer detection and prevention in the African American community.      Objectives:      - To learn more about how African Americans who have tested positive for BRCA1/2 mutations     tell their families about their genetic risk.      Eligibility:      - African American (or of African descent) women who recently received positive test results     for BRCA1/2 mutations.      Design:        -  Participants will be screened with a basic medical history.        -  They will be asked general questions about their personal and family history. These          include questions on marital and health insurance status, education, and income.        -  Those in the study will have a 45- to 60-minute phone interview. They will answer          questions about how they told their family members about their genetic test results.          They will also be asked what that experience was like.   "
145901|NCT01374607|"     It is crucial to rapidly identify cardiac ischemia in the care of patients with suspected     acute coronary syndrome (ACS). Cardiac troponins are a major factor in the diagnostic of     myocardial infarction. New methods have been developed to improve the accuracy of the assay     and determine low troponin concentrations. Elecsys® (highly sensible T troponin) TnT-HS assay     is supposed to help early detection of myocardial infarction after onset of symptoms. It     should therefore shorten the transit time to emergencies by a more rapid intervention or a     faster return home. The aim of the study is to compare TnT-HS assay to the standard troponin     assay in the detection of early cardiac ischemia in patients with ACS.   "
145902|NCT01374594|"     PURPOSE      The goal of the present project is to unravel the importance of bile acid-induced GLP-1     secretion (via the G protein-coupled receptor TGR5) in human physiology.      In the present study the investigators examine the GLP-1 secretion in healthy subjects and in     Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with     T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and,     consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1     responses (primary endpoint).   "
145903|NCT01374581|"     This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to     investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for     example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in     RDCongo, on malaria incidence and its potential selection of resistant strains.      Patients will be followed-up for efficacy and safety during 42 days after treatment with the     first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda     and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or     an other ACT or oral Quinine + clyndamicin.      The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14     days is as efficacious as any other rescue treatment, without the risk of selecting drug     resistant strains.   "
145904|NCT01374568|"     The purpose of this study is to determine if the use of sitagliptin increases bone formation     and reduces bone turnover in postmenopausal women with type 2 diabetes.   "
145906|NCT01374542|"     Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy.     The diagnostic yield, technical factors and complications for all patient sub-populations is     still not clearly defined. This may result in inappropriate or even dangerous application of     such procedures. The aim of the study is to collect data on these aspects of respiratory     endoscopy and identify important trends, as well as, areas for improvement. This data will     also provide baseline comparative data for new bronchoscopic techniques such as endobronchial     ultrasound and navigational bronchoscopy.      Method: Prospective data collection. Technical details regarding these procedures are     currently keyed into the OTM system by the endoscopy operators for documentation and billing.     The department of Respiratory and Critical Care Medicine gets monthly downloads of all the     fields from the OTM system for audit purposes.(See data collection form) The research project     proposes to make the data non identifiable by removing the patient's name and IC number.     Additionally the yield of the procedure will be checked by a chart review of the histology     and microbiology results. There are no restrictions on patient recruitment because all     procedures will be performed for clinical indications only and no patient will be recruited     for the sole purpose of the study. Waiver of consent has been approved by the IRB.   "
145907|NCT01374516|"     The aim of the study is to assess the efficacy of sanofi pasteur's CYD dengue vaccine in     preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin     America.      Primary Objective:      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in     preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due     to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of     inclusion.      Secondary Objectives:      To describe the occurrence of serious adverse events (SAEs), including SAEs of special     interest in all subjects throughout the trial period.      To describe the efficacy of CYD dengue vaccine after each dose in:        -  Preventing symptomatic virologically-confirmed dengue cases due to any of the four          serotypes        -  Preventing symptomatic dengue cases, either virologically-confirmed or probable based on          serological criteria, due to any of the four serotypes   "
145908|NCT01374503|"     The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor     ALX-0651 is safe and effective after single or multiple intravenous administrations to     healthy male volunteers.   "
145909|NCT01374490|"     This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg     twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive     (HIV+) subjects with diarrhea.   "
145910|NCT01374477|"     Hypertensive disorders of pregnancy are one of the most frequent complications of pregnancy,     being a serious health problem around the world.      Previous studies have suggested that there is an association between a short period of     exposure to paternal sperm of a new sexual partner and the development of an immunological     reaction that could trigger a hypertensive disorder of pregnancy. For this reason we want to     study the relationship between the primipaternity concept (exposure to male antigens present     in semen over a short period of time previous to the pregnancy) and the development of     preeclampsia in adolescents.   "
145924|NCT01374295|"     In order to compare two different forms of patient education; patients who receive Lortab     medication or prescription during their ED visit are randomized to receive either standard     patient education (from healthcare provider) or video assisted education. After education,     patient completes a survey, estimated to take 5 minutes to complete.   "
145925|NCT01373736|"     The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic     imaging agent in evaluating patients with known or suspected neuroendocrine tumors.   "
145926|NCT01373723|"     The aim of this study was to compare the effectiveness and the costs of three types of     population interventions to increase the number of female participants in the screening     programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care     Areas.   "
146117|NCT01371747|"     This study determined the optimal starting dose of patiromer in treating hyperkalemia in     participants with hypertension and diabetic nephropathy who were already receiving ACEI     and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and     safety of patiromer and the long term use of patiromer.   "
145911|NCT01374464|"     Shoulder surgery is known to be extremely painful requiring high doses of opiate analgesics     (morphine) to control pain. Morphine has numerous unwanted side effects including sedation,     hallucinations and vomiting.      It is now standard procedure for patients undergoing shoulder surgery to have their pain     controlled by means of an injection made around the nerves where they pass through the neck     to supply the shoulder with sensation (similar to the numbing injections made by the dentist     before a dental procedure). This injection is called a 'nerve block'.      Nerve blocks provide complete analgesia after shoulder surgery allowing clinicians to     discharge patients home on the day of surgery, pain free and with no opiate side effects.     However, a side effect of nerve blocks at this level is involvement of the phrenic nerve,     which is anatomically close to the injection point. This may cause (temporary) paralysis of     the diaphragm and in some cases, severe respiratory dysfunction.      Research shows that reducing either the volume or the concentration of the drug injected, can     reduce the consequent respiratory dysfunction. However no study has compared both volume and     concentration in parallel, to see which of these has the more significant effect in reducing     respiratory dysfunction. Furthermore there has been no assessment of how these changes may     affect the duration of analgesia received and patient coping after discharge.      The investigators propose to conduct a double blind randomised controlled trial at the Royal     Surrey County Hospital, enrolling patients presenting for elective day case arthroscopic (key     hole) surgery over a period of 6 months. Patients will receive one of four treatment     allocations:        1. Low concentration-high volume of local anaesthetic        2. Low concentration-low volume of local anaesthetic        3. High concentration-high volume of local anaesthetic        4. High concentration-low volume of anaesthetic drug of local anaesthetic.      The aim of this study is to inform an optimum dosing regimen for patients in order to     facilitate maximal pain relief and quality of recovery with minimum respiratory dysfunction.   "
145912|NCT01374451|"     This study will estimate the treatment effect of everolimus in combination with pasireotide     LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced     progressive PNET.      A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet     its primary objective, which was based on progression-free survival (PFS) as per local     radiology assessment and was prematurely terminated with the last patient last visit on     19-Feb-2015. However, it is important to note that the data did not reveal any new safety     concerns. It was decided to stop the study and this decision was shared with the study sites     on 31-Jul-2014.   "
145913|NCT01374438|"     This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to     the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in     older persons with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this     population will also be studied. These results will be used to design larger studies of     MSDC-0160 in persons with mild Alzheimer's disease.   "
145914|NCT01374425|"     This will be a randomized, open-label, multicenter, Phase II study with primary objectives to     assess whether expression of select chemotherapy markers is associated with progression-free     survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and     oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan     (FOLFIRI). The study population will consist of participants with first-line mCRC.   "
145937|NCT01373580|"     This study will be a prospective, multicenter clinical trial in which a total of 400 subjects     will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of     15 clinical sites participating. Qualified subjects will provide informed consent for entry     into the study.   "
146108|NCT01371864|"     Purpose:      -To evaluate the peri-operative communication between families and the pediatric cardiac     surgery team.      Method:      -In this study the investigators plan to utilize structured interview and survey of     parents/legal guardians and health care providers of children undergoing cardiac surgery in     the United States of America.   "
145915|NCT01374412|"     Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and     localized microcirculation in test animals with osteoporosis, fractures and after placement     of bone substitute material with volume computed tomography (VCT) (animals only) and     functional magnetic resonance imaging (MRI). Furthermore patients with multiple myeloma (MM)     will be examined before and after placement of a commercially available bone substitute     material. Osseous structures before intervention and structural changes of the bone     especially at the junction of substitute material and residual bone will be documented. At     this, the proposed techniques allow imaging of the dynamic healing processes in the living     organism.      As next step patients with asymptomatic MM will be investigated with functional Imaging     longitudinally to predict the occurence of osteolyses at time of Progression.      Hypothesis: Affection of microcirculation at the junction of bone and bone substitute     material can be displayed by VCT and functional MRI   "
145916|NCT01374399|"     The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an     one-year physical exercise intervention on prognosis, side-effects and complications after     allogeneic stem cell transplantation.      The exercise intervention includes both, resistance and endurance training. Patients assigned     to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen)     and have the same frequency of social contact.   "
145917|NCT01374386|"     The purpose of this study is to gather information on how much exercising with video games     (ExerGaming) can increase the physical activity among overweight and youth. This study will     try to see if participating in physical activity and exercising with video games at the same     time can make overweight children move around more to better their own health. The hypothesis     is that those in Exergaming arm will physiological changes and increase physical activity.   "
145918|NCT01374373|"     The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® )     administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia     (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.   "
145919|NCT01374360|"     This study is a collection of data to evaluate safety and characterize progression of     Paroxysmal Nocturnal Hemoglobinuria (PNH).   "
145920|NCT01374347|"     The study will be an open label one and will include 30 patients who underwent ischemic     stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain     SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second     brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor     matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study     will be performed 24 hours after the last dose.   "
145921|NCT01374334|"     Aging is associated with loss of muscle strength and a serious import of physical disability.     Treatment of age-related physical disability should focus on the prevention of the condition     rather than the consequences. Need to modify daily tasks is an early sign of future mobility     disability. Many older adults who utilize daily task modifications report no mobility     difficulty. Neglect to self-report task modification may delay intervention. Identifying     objective marker of task modification will help to identify task modifiers.   "
145927|NCT01373710|"     The purpose of this study is:      Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated     by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL)     near the conventional therapeutic concentration and depending on the dose-limiting toxicity     (DLT)      Phase II: Determination of antitumor activity trastuzumab when administrated by IT or     intra-ventricular in terms of neurological progression-free survival at 2 months   "
145928|NCT01373697|"     The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety     treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or     myofascial compared to Profenid 25mg/g gel.   "
145929|NCT01373684|"     This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative     chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the     degree of HBsAg decline.   "
145930|NCT01373671|"     The primary objective of this protocol is to collect the 2-dimensional (2D) screening and     diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from     patient mammography examinations acquired on various commercially available Full Field     Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.   "
145931|NCT01373658|"     Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and     delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from     a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may     prevent these complications.   "
145932|NCT01373645|"     Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and     delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from     a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may     prevent these complications.   "
145938|NCT01373567|"     Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting     approximately 2% of the world's population.This phase IV study is planned to monitor     performance of Tinefcon in patients suffering from psoriasis under conditions of actual use     and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients     treated with Tinefcon. This study will add to literature on the risks and benefits of     Tinefcon the novel oral TNF-alpha release inhibitor.   "
145939|NCT01373554|"     Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)     activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1     (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the     development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some     research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in     SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of     lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c.     Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c     pathway in liver.   "
145940|NCT01373541|"     The purpose of this study is to determine the effect of infant formula with high percentage     of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general     gastrointestinal tolerance in Chinese formula-fed term infants.   "
145941|NCT01374282|"     Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a     Compassionate Special Permit issued by the Bureau of Food and Drugs. Physicians were able to     request the drug for their patients from the Sponsor. A Clinical Study Report form was     completed for each purchase of Cuprimine.   "
145942|NCT01374269|"     Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and     improving function and quality of life during a 6-months follow-up of a therapeutic exercise     program compared to pharmacological treatment with NSAIDs in patients with subacute low back     pain attending the physiatrist consultation of several ambulatory health centers in Medellín     during the years 2009-2010.   "
145943|NCT01374256|"     Infections caused by imipenem-resistant Acinetobacter baumannii are associated with high     mortality and morbidity. The treatment choices for this resistant pathogen are limited.      The objective of the present proposal is to evaluate the effectiveness of combination therapy     of imipenem and sulbactam in patients contracted with A. baumannii, and to correlate the     clinical effect with the in vitro synergistic results.   "
145944|NCT01374230|"     This study has been designed to document the long-term outcome of the E1® Tibial Bearings     used with the Vanguard® Knee System in 50 patients receiving total knee arthroplasty. All     patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic     analysis and patient reported outcomes will be used as follow-up measures to track wear,     mechanical performance, and patient satisfaction.   "
145945|NCT01374217|"     The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in     combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.   "
145946|NCT01374204|"     Few data about epilepsy-associated stigma in France are available. The only study we have     found showed that in France 66% of people with epilepsy felt stigmatized by their condition     and are often single, compared with the other European patients interviewed (Baker et al.,     2000). The purpose of this study is to assess the association between type of epilepsy (drug     resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in     patients recruited in the Limousin region .   "
145947|NCT01374191|"     The purpose of this study is to determine if botulinum toxin type A (Btx-A) is an effective     treatment for painful neuromas. The ideal therapy for painful neuromas would be effective,     non-addictive, safe, localized, and cost-effective treatment. At the same time, the therapy     would also address the complex peripheral and central mechanisms. Btx-A is a potential     treatment that addresses each of these requirements while preserving the existing sensation     and function.      Study Hypothesis: Btx-A injection relieves neuroma pain better than a placebo   "
145948|NCT01374178|"     The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of     LY2963016 compared to those of basal insulin. The study will also gather information on the     safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12     weeks.   "
146118|NCT01371734|"     This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR)     versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive     Disorder (MDD).   "
145949|NCT01374165|"     Prolong proposes to test safety, tolerability and pharmacokinetics of SANGUINATE™ in sickle     cell disease (SCD) patients. Prolong's preclinical studies showed that SANGUINATE™ was safe     in a number of different animal models and toxicology studies. In this Phase I trial, Prolong     will test whether it is also safe and tolerable in sickle cell patients. The study will be     conducted in 15 adult (>18 years) patients.   "
145950|NCT01374152|"     The cognitive sensory motor training therapy (Perfetti's technique) might be more     effectiveness than conventional occupational therapy on upper extremity function recovery     after acute stroke patients.   "
145951|NCT01374139|"     The purpose of this study is to demonstrate the bioequivalence of the clinical tablet     formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects     under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the     pharmacokinetics of bosutinib after administration of the proposed commercial tablet     formulation (100 mg x 4) in healthy subjects (Cohort 2).   "
145952|NCT01374126|"     A randomized controlled trial to assess the safety and efficacy of azithromycin combination     therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated     malaria patients in southeastern Bangladesh.   "
145953|NCT01374113|"     The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the     compound in the body) of safinamide in subjects with different degrees of renal impairment in     comparison to matched subjects with normal renal function.   "
145974|NCT01373840|"     Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained     muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in     the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather     rudimentary. A better understanding of neural mechanisms of dystonias is not only an     invaluable prerequisite for developing better treatment options but also a step toward better     understanding of the complex network of basal ganglia. In this study I will investigate if     there is any difference between the dopamine receptors and dopamine in people with dystonia     and healthy subjects.   "
145954|NCT01374100|"     Cancer patients face a number of symptoms related to treatment or disease which may impair     quality of life, such as decreased functional capacity, fatigue, nausea an vomiting,     distress, depression and unmet psychological needs. Due to this array of symptoms, cancer     patients often seek supportive complementary and alternative medicine, which many patients     use along with conventional treatments. Qigong, a type traditional chinese medicine, is a     mind-body exercise that combines meditation, slow physical movements, and controlled     breathing. The investigators hypothesise that Qigong therapy is better in the reduction of     anxiety and depression levels and the improvement of quality of life in patients with lung     and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to     standard exercise training.   "
145955|NCT01374087|"     The primary objective of the study was to compare the efficacy of brachytherapy versus     brachytherapy + triptorelin 22.5 mg (single injection) in subjects with recurrence of     prostate cancer previously treated with radiotherapy. Efficacy was to be assessed by     biochemical failure-free survival (BFFS) curves from treatment initiation up to 5 years.      Secondary objectives included comparing the following: the differences in time to progression     of subjects receiving brachytherapy + triptorelin 22.5 mg versus subjects receiving     brachytherapy only, the BFFS percentages between both treatment groups at 5 years from     treatment initiation, overall survival between both treatment groups, total testosterone     changes (from baseline visit up to 12 months) and Prostate Specific Antigen (PSA) levels     (from baseline visit up to 60 months of treatment) between both treatment groups, quality of     life (QoL) modifications (Spanish version of the Expanded Prostate Cancer Index Composite     (EPIC) questionnaire) between the baseline score and the rest of measurements, and to compare     safety between both treatment groups.   "
145956|NCT01374074|"     The goal of the proposed research is to investigate the molecular mechanisms of racial     disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma.     Specifically, the investigators hypothesize that environmental factors, genetic factors, and     potentially gene environment interactions play crucial roles in the observed racial disparity     in developing Barrett's esophagus.      Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy     (EGD). Participants complete a questionnaire, have body measurements obtained, and have     blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH     impedance test.   "
145957|NCT01374061|"     The objective of this work is to compare standard intubation with video laryngoscope (Glide     scope Ranger ) in French pre hospital multicentric study.   "
145958|NCT01374048|"     Patients are subjected to simultaneous intracranial and lumbar puncture pressure     measurements. This study focus on intracranial pulse amplitude. Hypothesis: Intracranial     pressure amplitude is reflected by lumbar puncture pressure amplitude.   "
145959|NCT01374035|"     The main object to this trial is to study the function of referral letters as a mean to     coordinate the care process for adult people when referred from Primary Care to Specialised     Mental Health Care. The study will explore if and to what degree the quality of these     referral letters can be improved, and the potential improvement's impact on defined patient-,     professional and organisational related outcomes. According to Medical Research Council     guidelines for evaluating complex interventions, a stepwise design with the use of both     qualitative and quantitative methods will be used to conduct a controlled intervention study.   "
145969|NCT01373905|"     Acute respiratory distress syndrome is a severe lung disease caused by a variety of direct     and indirect issues. It is characterized by inflammation of the lung parenchyma leading to     impaired gas exchange and persistent hypoxemia. This condition is often fatal, usually     requiring mechanical ventilation. Recruitment maneuver aimed to enhance the effect of     mechanical ventilation.The objective of this study was to compare safety and efficacy of two     lung recruitment maneuvers.   "
146027|NCT01372917|"     The study is a prospective multi-centered cohort study designed to determine the safety and     efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the     study is designed to determine if sterility of human acellular dermal matrix results in a     lower incidence of infection and seroma. The study will determine if gamma radiation, as a     method of terminally sterilizing human acellular dermal matrix, has a negative impact on     graft incorporation into the host tissue.   "
145960|NCT01374022|"     Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit.     Discussions about it is exponentially growing up due its high mortality rates all over the     world and low quality of life among survivors. Mechanical ventilation is recognized to play     an important role in treatment of patients with ARDS. However, mechanical ventilation itself     has the potential to produce or worsen alveolar injury if inadequate strategies are chosen.     Several studies compared different mechanical ventilation strategies in ARDS but the results     remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a     multicentric randomized controlled trial, with allocation concealment and intention to treat     analysis to investigate if maximum alveolar recruitment maneuver in association to Positive     end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART     strategy) is able to increase 28 days survival in patients with moderate to severe ARDS     compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy).     Patients considered to this trial are those in mechanical ventilation with diagnosis of     moderate to severe ARDS less than 72hours. Patients included will be randomized to receive     ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6     months.   "
145961|NCT01374009|"     The goal of this study it to rapidly create a brief registry of pregnant women who receive     the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1     2009/2010 influenza season.   "
145962|NCT01373996|"     The purpose of this study is to determine whether wireless transmission of invasive arterial     blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor     is feasible, safe and as accurate as conventional cable connection.   "
145963|NCT01373983|"     The purpose of this study is to evaluate if the effect of ziconotide can be tested by     intrathecal bolus doses.   "
145975|NCT01373827|"     Patients enrolled in this study will come from the Investigator's patient population and be     ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no     different if they participate than if they do not. The study is only to observe the patients     before, during and after their usual treatment.   "
145976|NCT01373814|"     The goal of this study is to determine if nutritional therapy can effectively treat/prevent     T2DM and its consequent cardiomyopathy.   "
145977|NCT01373801|"     The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR     compared to standard bandaging in subjects with post partum hemorrhage as a result of     cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30     minutes after insertion of the dressing.   "
145978|NCT01373775|"     To identify the risk factors of the revisit of the adult HF patients in emergency department.   "
146201|NCT01370629|"     This non-interventional prospective study is a post-authorization safety study (PASS) of     vernakalant conducted to collect information about normal conditions of use and appropriate     dosing, and to quantify possible medically significant risks associated with the use of     vernakalant in real-world clinical practice.   "
145964|NCT01373970|"     Proton pump inhibitors (PPI) have been shown to cause acid reflux related symptoms at     withdrawal in healthy volunteers, a phenomenon known as Rebound Acid Hyper Secretion. Whether     this also applies for patients with dyspeptic symptoms but without true reflux disease     (functional dyspepsia) treated with PPI is unknown. If this is the case, it could lead to an     unfortunate long term use of PPI, since the acid rebound renders withdrawal too difficult.      This is a single centre, randomized, double-blinded, placebo-controlled cross over study.     Study period is 12 weeks per study subject. Study subjects are referred to the study from     General Practitioner (GP) and the gastroenterology department or endoscopy clinic of the     investigational centre.      The study population consists of patients who seek their GP because of dyspepsia without     alert signs, and whom the GP may consider starting on PPI. Out patients referred to the     gastroenterology department or endoscopy clinic of the investigational centre because of     dyspepsia without specific exclusion criteria are also invited to participate.      Baseline interview, upper endoscopy and pH monitoring are performed one week before inclusion     to exclude patients with GERD. Helicobacter Pylori (Hp.) status is assessed by Helicobacter     Urease Test (HUT). Hp. positive subjects without ulcus are not excluded.      Patients with a positive pH monitoring will not be included in the analysis regarding the     primary endpoint (Development of GERD) but will be included in the analysis regarding one of     the secondary endpoints (Effect of PPI on Functional Dyspepsia).      Study subjects are randomized to either pantoprazol followed by cross over to placebo or to     placebo. Escape medication in the form of Gaviscon can be used on demand.      Internet based questionnaires are answered weekly. Questionnaires consist of the     Gastrointestinal Symptom rating Scale (GSRS) in combination with items assessing postprandial     fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease     (GERD).      Compliance to protocol is assessed at hospital visits every fourth week. At the end of study     endoscopy and pH monitoring are repeated.   "
145965|NCT01373957|"     EPICOR-RUS is a multi-centre, observational, prospective, longitudinal cohort study which     will include patients, in a real-life setting, who are hospitalized for acute coronary     syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable     Angina (UA), ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial     Infarction (NSTEMI). Patients will undergo clinical assessments and receive the standard     medical care as determined by the treating cardiologist. Patients will not receive     experimental intervention or experimental treatment as a consequence of their participation     in the EPICOR-RUS observational study.   "
145966|NCT01373944|"     The purpose of this study is to compare clinical efficiency and patient outcomes using ultra     low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.   "
145967|NCT01373931|"     This study involves a single dose of 18 mg LY2216684 taken as 1 or 2 tablets by mouth. The     study will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive     Ortho Cyclen®. This study will run approximately 93 days.   "
145968|NCT01373918|"     Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral     Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to     prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of     standard intravenous fat emulsions have implicated in the development and progression of     PNAC.      In this study, neonates with congenital/acquired gastrointestinal disorders will be     randomized, in a unblinded fashion, to receive either the standard dose of an intravenous     omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion     throughout their course of PN or until hospital discharge, death or 100 days of life,     whichever comes first. The primary outcome will be the presence of cholestasis.   "
146010|NCT01373138|"     This is an open label randomised, 2-way crossover, comparative bioequivalence study.   "
146119|NCT01371721|"     This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate     sustained release (DVS SR) in the treatment of child and adolescent outpatients with major     depressive disorder (MDD).   "
145970|NCT01373892|"     The objectives of this study are to measure effect of obesity on brain structure and     molecular pathways, food-stimuli mediated brain activation response, on hormones affecting     both feeding and energy balance as well as on bone metabolism and bone marrow fat. In the     first phase the studies are performed at baseline before bariatric surgery and in the second     phase post-operatively after 6 months. Regional free fatty acid uptake are studied with PET     and 14(R, S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). Changes in body fat     distribution are investigated with magnetic resonance imaging (MRI) Brain reward system     response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter     volumes using diffusion tensor imaging (DTI). Brain neurotransmitter system will be measured     with [11C]raclopride and [11C]carfentanil and PET. In the second part of the study the same     variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or     Roux-en-Y gastric bypass.   "
145971|NCT01373879|"     The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and     AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria     endemic region. The regimen proposed here has protected non-immune volunteers in Oxford     against sporozoite challenge, and so may be protective against naturally acquired infection     in The Gambia.   "
145972|NCT01373866|"     -  The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from          drug-resistant multisensory hallucinations will be tested by the implementation of a          double-blind randomized controlled trial (RCT)        -  This study will use a combination of different MRI modalities (fMRI and DTI) to define          with precision rTMS brain-targets in the case of multisensory hallucinations        -  The investigators anticipate that multimodal MRI-guided rTMS will allow a significant          improvement in the efficacy of neuromodulation treatment of refractory hallucinations   "
145973|NCT01373853|"     This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye     study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted     lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL     implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the     CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and     height dependent on anterior chamber depth, pupil diameter and ocular lens size.      The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation     the required ultrasound energy used for phacoemulsification can be reduced in a safe and     effective way.   "
146202|NCT01370616|"     This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of     moderate to severe diabetic foot infections. The primary hypothesis was that treatment with     ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in     achieving clinical improvement or cure.   "
145979|NCT01373762|"     The purpose of this study is to determine whether an interactive exercise videogame bike is     effective in improving physical activity adherence, motivations to do physical activity, and     physical fitness among families. Families receive either an interactive videogame bike and     gaming console, or a traditional stationary bike which is placed in front of the television,     to keep in their home for six months. It is expected that families within the videogame bike     condition will show greater exercise adherence. It is also expected that these families will     have higher self-reported physical activity levels, greater motivation to do physical     activity, and improved cardiovascular fitness at the end of the three month period compared     to the families in the stationary bike condition.   "
145980|NCT01373749|"     Nitro Oxide (NO) inhalation was recognized as an effect treatment of Neonatal Persistent     Pulmonary Hypertension (PPHN), while the safety of NO long term application was under     investigation. Several research suggested too much NO2 was generated in the lung after long     term (> 72h) use of NO inhalation, which cause bad effects on PS production.      Sildenafil was proved to be effective to PPHN as NO. This medication has a similar clinical     effect but need monitoring of blood pressure. The possible hypotension effect restrict the     dosage of sildenafil, which limit the usage of sildenafil in severe PPHN. But we recommend     sildenafil to The purpose of the study was to establish if NO continued with sildenafil has     the same effect as single NO inhalation.   "
145981|NCT01373528|"     Chronic rhinosinusitis (CRS) is a complex inflammatory disease that is treated primarily with     sinus surgery and the long-term use of topical steroid therapy. Budesonide irrigation is a     common method of topical steroid treatment for these patients. However, the effects of     budesonide irrigation on the hypothalamic-pituitary-adrenal (HPA) axis in patients with CRS     following sinus surgery, is as of yet not defined. The objective of this study is to     determine if topical sinonasal budesonide steroid irrigation leads to acute recoverable     and/or long-term suppression of the HPA axis. Participants in this prospective cohort study     will have CRS and have recently undergone endoscopic sinus surgery. They will also have had     planned use of budesonide irrigations as their postoperative medical treatment. The acute     effects of this treatment on the HPA axis will be evaluated using serial serum cortisol     measurements both the day before and the day of the first budesonide irrigation. The     long-term effect of sinonasal budesonide irrigation will be evaluated using both a pre- and     post-treatment adrenocorticotropic hormone (ACTH) stimulation test as well as repeated urine     free cortisol levels over the length of the study. The results will determine the need for     additional steroids when patients stop treatment or with a physiologic stressful event.   "
145982|NCT01373515|"     This is an open label phase 1 feasibility and safety dose escalation study. The main     objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.   "
145983|NCT01373502|"     The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy     of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic     lesions in native coronary arteries.   "
145984|NCT01373489|"     The purpose of this study is to help low income patients achieve and maintain better     self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood     pressure monitoring system and nurse case management. Patients must be served at a Federally     Qualified Health Center (FQHC) in coastal South Carolina.   "
145985|NCT01373476|"     Objectives of study: To preliminarily evaluate the efficacy and safety of Qideng Mingmu     Capsule in the treatment of patients with diabetic retinopathy (deficiency of Qi-Yin     syndrome, blood stasis syndrome), to discuss the appropriate dose and period of treatment.   "
145986|NCT01373463|"     This study is open to patients that have been diagnosed with non-squamous Stage III Non Small     Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.      The purpose of this study is to:        -  Test a combination of two chemotherapeutic drugs along with radiation therapy, when          given prior to surgery and see what effects (good or bad) it has on someone with this          type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and          tissues.        -  Test the safety of different dose levels of radiation when given with each combination          of chemotherapy;        -  Determine what side effects are associated with combining radiation with these two          chemotherapy combinations.   "
145987|NCT01373450|"     This was a four-period crossover study to assess the glycemic effects of a single dose of     oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus     (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4     treatment periods, with a 7-day wash-out between each treatment period. The primary     hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or     better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly     enhancing insulin secretion.   "
145988|NCT01373437|"     The purpose of this study is to assess the applicability of using ultrasonography in     confirmation of the position of the endotracheal tube (ETT) after intubated to patients.   "
145989|NCT01373424|"     Dystonia is a disorder characterized by excessive involuntary contraction of muscles with     repetitive and patterned movements. The isolated dystonias are the most common type of     dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic     torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias     (like blepharospasm). The purpose of this study is to create resources to help learn more     about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop     and validate various dystonia rating scales.   "
145990|NCT01373411|"     Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and     randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48     hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which     time they will receive telephone follow-up one and nine months following CABG and clinic     visits three, six, and twelve months following CABG.   "
145991|NCT01373398|"     The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical     instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).   "
146203|NCT01370603|"     The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg     combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin     40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.   "
145992|NCT01373385|"     The purpose of this research is to provide a clearer understanding of quality and outcomes     for three types of surgical procedures performed at Connecticut Children's for treatment of     vesicoureteral reflux. In order to consistently gather data over time, the investigators     propose to establish database for surgical intervention for vesicoureteral reflux.      Specific Aim 1: To consistently collect performance and outcomes data for the surgical     treatment of vesicoureteral reflux in order to increase internal understanding of these     procedures.      Specific Aim2: To consistently collect performance and outcomes data for the surgical     treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for     publication.   "
145993|NCT01373372|"     Chronic abdominal pain is the most common persistent pain condition in children and     adolescents, affecting 10-15% of children at any given time. One of the most often diagnosed     types of abdominal pain is functional dyspepsia (FD). FD is an abdominal pain or discomfort     (e.g., nausea, bloating) in the upper abdomen that does not get better by going to the     bathroom.      For some people it appears that stress can make FD worse. In adults, stress can cause the     release of a hormone called corticotropin releasing hormone (CRH). The release of CRH can     cause abdominal pain by affecting how fast things move through a person's stomach and     intestines. This makes the organs in the abdomen more sensitive to pain, causing tenderness     of the inside lining of the stomach and intestines.      Different people react differently when the body releases CRH. Some people have abdominal     pain without feeling any stress or anxiety while other people who have a lot of stress or     anxiety don't have any abdominal pain. Some people have neither stress, anxiety, or abdominal     pain when CRH is released into the body.      In order to see how the bodies of children with functional dyspepsia and those without     functional dyspepsia react to CRH, we will do a CRH stimulation test. A CRH stimulation test     is routinely done in endocrine patients. It is not routinely done for patients with     functional dyspepsia or for patients who do not have functional dyspepsia.      Part of the CRH stimulation test is giving a synthetic type of corticotropin, Acthrel® (brand     name for Corticorelin), as injection. Acthrel® has been approved by the Food and Drug     Administration (FDA) for use.      The purpose of this research study is to see if there are differences in how the bodies of     children with functional dyspepsia react to CRH versus children who don't have functional     dyspepsia.      Being in this study involves one clinic visit where an IV placed and a CRH stimulation test.     In this test the child will be given an injection of CRH and then observed for one hour.     During that hour the child will have five blood draws through the IV and will be asked     questions about their anxiety and abdominal pain. This visit will take about 4 hours.      The following things will happen:        -  Your child will be asked to come to the clinic between 8a.m. and 10a.m. fasting. This          means your child will have had nothing to eat or drink for 8 hours before coming to the          clinic.        -  If your child is a female ten years of age or older, or has started having periods, a          urine pregnancy test will be done before receiving the CRH infusion.        -  You and your child will each be asked to complete a survey that measures your child's          anxiety.        -  Your child will have a biofeedback session that will measure your child's stress. In a          biofeedback session, sensors are placed on your child's fingers, wrists and forehead.          These sensors are connected to a computer that monitors your child's heartbeat, skin          temperature and electrical pulses on your child's skin.        -  Your child will have an IV inserted into a vein in his/her arm. Your child may have a          cream put on their arm to help with the pain of the IV insertion. The IV will be used to          inject the CRH and draw blood. If the IV stops working and blood samples can no longer          be drawn from it, your child may have another IV started or blood samples may be drawn          by needle stick.        -  Your child will then have 30 minutes to relax.        -  Your child will then have CRH infused through the IV over one minute.        -  Your child will have blood drawn through the IV five times; right before the CRH          stimulation test begins and 15, 30, 45 and 60 minutes after the CRH infusion. The total          amount of blood drawn for the study will be about 2 ½ tablespoons.        -  Your child will be asked about their abdominal pain, nausea, bloating, stress and          anxiety at three separate times during the 60 minutes.        -  Your child's heart rate will be measured throughout the CRH stimulation test.   "
145994|NCT01373359|"     Sublingual misoprostol produces rapid peak concentration and is more effective than oral     misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test     whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have     30 ml less average blood loss than women receiving oxytocin, the standard of care for     prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial     of .652 consenting, eligible pregnant women admitted to the labor room of the teaching     hospital at J N Medical College, Belgaum, India. Women participating in the study were     assigned by computer generated randomization to receive the study medications and placebos     within one minute after clamping and cutting the umbilical cord. We also looked at the drugs     effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent     of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.   "
145995|NCT01373346|"     We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric     cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en     Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.   "
145996|NCT01373333|"     Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton     Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with     LEMS and hopefully will decrease the need for prednisone and all other therapies that were     previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if     he/she is seeing benefits from the medication or experiencing side effects that will prevent     them from continuation in the study.   "
145997|NCT01373320|"     The study purpose is to evaluate the effectiveness of a set of culturally appropriate,     faith-placed lay health advisor interventions aimed at facilitating smoking cessation and     increasing cancer screening among Appalachian participants.   "
145998|NCT01373307|"     The study purpose is to evaluate the effectiveness of a culturally appropriate, faith-placed     lay health advisor intervention aimed at increasing fruit and vegetable intake and physical     activity among intergenerational Appalachian individuals and families.   "
145999|NCT01373294|"     The purposes of this study are to:        -  find out whether participants' cancer returns or gets worse while they are taking          lenalidomide and Bacille Calmette-Guerrin (BCG);        -  evaluate the safety and tolerability of the combination of lenalidomide and BCG;        -  compare the cancer progression of participants taking lenalidomide and BCG versus          participants taking only BCG   "
146011|NCT01373125|"     The investigators propose a study comparing the morphological and functional aspects of the     neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)     to that of native squamous epithelium in normal controls as well as gastroesophageal reflux     disease (GERD), non-Barrett's Esophagus (BE) subjects.   "
146000|NCT01373281|"     The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing     symptomatic, virologically-confirmed dengue cases.      Primary Objective:      To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in     preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due     to any of the four serotypes in children aged 2 to 14 years at the time of inclusion.      Secondary Objectives:      To describe the efficacy of CYD dengue vaccine after each dose in:        -  Preventing symptomatic virologically-confirmed dengue cases due to any of the four          serotypes        -  Preventing symptomatic dengue cases, either virologically-confirmed or probable based on          serological criteria, due to any of the four serotypes      To describe the occurrence of serious adverse events (SAEs), including serious adverse events     of special interest in all subjects throughout the trial period.   "
146001|NCT01373255|"     Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted     into the uterine myometrium. The most significant complication is intense bleeding, mainly     during labor. The most important risk factors are previous cesarean delivery, placenta     previa, and advanced maternal age. Cesarean hysterectomy is the recommended management.     During the recent years, inserting intravascular balloon catheter for occlusion and/or     arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss     during cesarean hysterectomy or in conduct with conservative management with the intent of     avoiding hysterectomy in selective cases. Contradicting reports exist regarding the     effectiveness and safety of the catheters in cases of placenta accreta. The objective of this     study is to estimate the efficacy of the balloon catheters among women diagnosed with a     placenta accreta.   "
146002|NCT01373242|"     The goal of this study will be to increase the reaction threshold (desensitization) of peanut     allergic children using peanut sublingual immunotherapy and to determine if the nonreactive     state of the immune system persists after treatment has been discontinued (tolerance).   "
146003|NCT01373229|"     In research studies, lenalidomide (also called Revlimid) has shown some response in chronic     lymphocytic leukemia (CLL); however, responses are usually partial responses that occur after     several months of taking the study drug. It is thought that by adding the drug plerixafor     (also called Mozobil) responses may be improved and/or occur sooner.      The main purpose of this study is to determine the dose of plerixafor that is safe to use in     combination with lenalidomide. The study will also look at the response rates of the     combination of lenalidomide and plerixafor and the effect the study drugs have on CLL cells.   "
146017|NCT01373047|"     The purpose of this study is to collect data on the safety and potential effectiveness of 2nd     generation designer T cells delivered into the hepatic circulation in patients with liver     metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white     blood cells from the participant, and then modifying these cells in the laboratory so that     they recognize the tumor antigen, CEA. These modified cells are then given back into the     participant so that they can attack and kill tumor cells. The investigators hypothesize that     regional delivery of the designer T cells directly into the hepatic artery will minimize     systemic toxicity and optimize the changes for therapeutic effect.   "
146004|NCT01373216|"     GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects     on cardiac function and metabolism in both experimental models and in patients with type 2     diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and     glucose control in patients undergoing cardiac surgery are not known. Based on the results of     experimental studies there is a potential for exenatide to positively influence both cardiac     function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes     mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative     administration of exenatide affects perioperative hemodynamics, echocardiographic parameters,     necessity of antiarrhythmic and inotropic treatment and glucose control in patients with     coronary atherosclerosis and decreased left ventricular function undergoing elective coronary     artery bypass grafting operation (CABG). In addition, safety and tolerability of     peri-operative administration of exenatide in these patients will be examined as a secondary     study objective.   "
146005|NCT01373203|"     The important character of acute lung injury (ALI) is alveolar capillary membrane damage     caused by different diseases, such as sepsis, trauma and shock. One of the important     pathological stages is the varying degrees of interstitial fibrosis and semi-permeable     alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived     factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated     that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by     ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was significantly     increased in asthmatic patients with pulmonary fibrosis, which companies with increased CTGF     expression. Therefore, this project assumes that fibrocyte will differentiation to     fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to     progression of fibrosis. The central hypothesis of this project is that peripheral progenitor     cell fibrocytes play an important role in alveolitis caused by acute lung injury. The overall     objective of this project is to study the role of fibrocytes in acute lung injury.   "
146006|NCT01373190|"     The specific aim is to determine if there are patterns of temperature differences in the     abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a     non-epileptic control group. The hypothesis is that individuals with partial/focal onset     epilepsy will have colder recorded temperatures in the abdominal area than individuals in a     matched control group.   "
146007|NCT01373177|"     The objective of this randomized study is to test the hypothesis that scores on the Bayley     Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of     Infant Development-II (BSID-II) in the same group of infants who were born very preterm.   "
146008|NCT01373164|"     Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with     gemcitabine in patients with solid malignancy      Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable     pancreatic cancer when treated with a combination of LY2157299 and gemcitabine with that of     gemcitabine plus placebo.   "
146009|NCT01373151|"     The purpose of this study is to determine the effective dose of BMS-945429 in subjects with     inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid     Arthritis.   "
146012|NCT01373112|"     Infection remains a difficult-to-treat complication of total knee arthroplasty. The gold     standard treatment is two-stage removal of the prosthesis with later replacement of permanent     implants. The first stage consists of removal of the infected arthroplasty components and the     surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary     antibiotic-impregnated cement spacer. This spacer typically is left in place six weeks,     during which time the patient receives intravenous antibiotics. After the surgeon feels that     the infection has been eradicated, or if the patient requires repeat debridement, a second     operative procedure is performed. While the use of an antibiotic-loaded spacer is well     accepted, whether the spacer should immobilize the knee (a so-called static spacer) or     allow for range of motion (a so-called articulating spacer) is controversial. Proponents of     articulating spacers argue that they prevent scarring of the musculature surrounding the knee     resulting in easier reimplantation, improved long-term knee function, and improved range of     motion. Proponents of static spacers argue that immobilization of the periarticular soft     tissues aids in clearance of the infection and is simpler to fashion intraoperatively. While     good results have been described with both methods, comparative trials have been conflicting     as to whether spacer design alters knee function, operative time, and range of motion.     Equipoise exists within the literature, and no randomized clinical trial has been conducted     to evaluate this issue.      The purpose of this study is to compare articulating and static antibiotic-impregnated     spacers for the treatment of chronic periprosthetic infection complicating total knee     arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to     determine the effect of spacer design upon eradication of infection, knee function, ease of     reimplantation, and range of motion. The investigators hypothesize that articulating spacers     will provide shorter operative times at reimplantation, while improving knee function and     range of motion.   "
146013|NCT01373099|"     Infection remains one of the most difficult-to-treat complications of total hip arthroplasty.     The gold standard treatment is two-stage removal of the prosthesis with later replacement of     permanent implants.The first stage consists of removal of the infected arthroplasty     components and the surrounding devitalized tissue, copious pulsed irrigation, and placement     of a temporary antibiotic-impregnated cement spacer. This spacer is typically left in place     six weeks, during which time the patient receives intravenous antibiotics. After the surgeon     feels that the infection has been eradicated, or if a second debridement is required, a     second operative procedure is performed. While the use of an antibiotic spacer is well     accepted, whether the spacer should immobilize the hip (a so-called static spacer) or allow     for range of motion (a so-called articulating spacer) is controversial. Proponents of     static spacers argue that immobilization of the periarticular soft tissues aids in clearance     of the infection and that these spacers are simpler to fashion intraoperatively. Proponents     of articulating spacers argue that they improve hip function, prevent damage to the     musculature surrounding the hip, allow easier reimplantation, improve hip function, and     prevent dislocation following hip reimplantation. While good results have been described with     both methods, comparative trials have been conflicting as to whether spacer design alters hip     function, operative time, and dislocation rates. Equipoise exists within the literature, and     no randomized clinical trial has been conducted to evaluate this issue.      The purpose of this study is to compare articulating and static antibiotic-impregnated     spacers for the treatment of chronic periprosthetic infection complicating total hip     arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to     determine the effect of spacer design upon eradication of infection, hip function, ease of     reimplantation, and dislocation rates. The investigators hypothesize that articulating     spacers will provide shorter operative times at replantation while improving hip function and     hip dislocation rates following hip reimplantation.   "
146014|NCT01373086|"     This study will assess the efficacy and safety of LFF269 compared to placebo after treatment     in subjects with essential hypertension.   "
146015|NCT01373073|"     The purpose of this study is to assess growth of preterm infants fed human milk supplemented     with an experimental human milk fortifier.   "
146016|NCT01373060|"     This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of     ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.   "
146020|NCT01373008|"     Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly     treated with inhaled steroids, an optional treatment according to textbooks and guidelines .     However, the evidence supporting this treatment in spontaneously breathing infants is     limited, and based on only two randomized, placebo-controlled trials (RCT) with relative     small number of infants . The Cochrane review concluded that these studies do not allow firm     conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants . Thus,     there is no doubt that there is a need for more RCT in order to ascertain the role of inhaled     steroids in infants with BPD. Because of its physical properties that theoretically make QVAR     an attractive therapy in infants and studies showing it to be as effective as and with     similar safety profile as other inhaled steroids in children, the investigators hypothesized     that inhaled QVAR will be an effective therapy in infants with BPD.   "
146021|NCT01372995|"     The increasing rate of hospital-acquired infection and antibiotic resistance are major causes     of prolonged ICU stay and death in hospitalized patients. The enormous impact of ICU-related     infection demands the need for cost-effective therapies that can be rapidly implemented to     improve patient immune response to control infection. Unfortunately, little high-quality     comparative effectiveness research has been performed on micronutrient treatment regimens as     methods to decrease hospital-acquired infection in critically ill patients. Critically ill     medical and surgical patients have an extremely high prevalence of vitamin D insufficiency.      We will perform a rigorous, double-blind, randomized, controlled, pilot clinical trial in     ventilator-dependent ICU patients to test the clinical/metabolic safety and efficacy of two     doses of oral high-dose vitamin D3 therapy versus standard therapy (no supplemental vitamin     D). The primary endpoint is to test whether high-dose regimens [either 50,000 or 100,000     international units (IU) of enteral vitamin D3 given daily for 5 consecutive days (total dose     = 250,000 or 500,000 IU, respectively) increase plasma 25(OH)D concentrations into a     desirable range (> 30 ng/mL).   "
146022|NCT01372982|"     The purpose of this study is to compare bioavailability in healthy, post menopausal women     subjects under fed conditions.   "
146023|NCT01372969|"     The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem     cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.   "
146024|NCT01372956|"     This is a multi-centre, cross-sectional, chart review study to investigate cholesterol goal     attainment rates defined by modified NCEP-ATP III guidelines and define its possible     determinants among Korean dyslipidemic patients   "
146025|NCT01372943|"     CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which     may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse.     Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. Stool     transplant (infusing donor stool into the intestine of the recipient), is not very palatable     to either patient or medical personnel. The investigators will isolate intestinal bacteria     from donor stool and use this purified mixture of donor bacteria instead of stool transplant.     The investigators hypothesize that this cleaner mixture of purely isolated intestinal     bacteria from a healthy donor would be equally effective as conventional fecal     bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and     anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora     reconstitution. However our approach would provide a more controlled, reproducible, cleaner     and more aesthetically acceptable method of administration, and from a patient safety     perspective, would also be a safer strategy than using freshly defecated donor fecal matter.   "
146028|NCT01372904|"     Cisplatin is a widely used chemotherapeutic agent for the treatment of various malignant     neoplasms, including testicular, ovarian, bladder, cervix uteri, head and neck and lung     cancers.      One of the common side-effects of this drug is bilateral, symmetric, progressive and usually     irreversible sensorineural hearing loss.      Cisplatin induces cochlear toxicity by the production of reactive oxygen species (ROS).      Dexamethasone treatment is currently practiced for various pathologies afflicting the inner     ear. The positive effect of Dexamethasone is attributed to it's anti ROS activity and it's     capability to up-regulate cochlear anti ROS enzymes.      In order to reach higher inner ear concentration of the drug while avoiding it's undesirable     systemic side-effects, Intratympanic (IT) delivery of Dexamethasone became vastly used in the     last decades for the treatment of sudden sensorineural hearing loss and Meniere's disease.      Dexamethasone inserted IT, diffuse across the round window into the inner ear perilymph where     it exerts its therapeutic effects.      The investigators review of the literature yielded three animal studies which examined the     protective effect of IT dexamethasone in the prevention of cisplatin-induced hearing loss.     These studies demonstrated promising results pointing to the potential for IT dexamethasone     in the prevention of cisplatin ototoxicity in humans.      The purpose of this study is to examine possible protective effect of IT dexamethasone on     cisplatin-induced hearing loss, in humans.      The study hypothesis is that IT dexamethasone treatment would prevent cisplatin-induced     hearing loss.   "
146029|NCT01372891|"     The present study is to determine the ability of urinary total adiponectin and its isoforms     excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing     PCI.   "
146030|NCT01372878|"     This study was design to establish the effectiveness of PillCam® Platform with the PillCam®     COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to     optical colonoscopy.   "
146031|NCT01372865|"     The primary objective will be to compare the impact of the study formulations on alergic     rhinitis carriers.   "
146032|NCT01372852|"     The objective of present study were to compare plasma adiponectin isoform status, their     bioactivities newly diagnosed Chinese with healthy volunteer.   "
146035|NCT01372813|"     Background:        -  One way tumors are able to grow is by forming new blood vessels that supply it with          nutrients and oxygen.        -  Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface          of tumor and blood vessel cells that are involved with the formation of new blood          vessels.        -  Blocking these proteins may prevent the tumor cells or blood vessels from continuing to          grow.      Objectives:        -  To determine whether vandetanib can cause tumors to shrink or stabilize in patients with          advanced kidney cancer.        -  To determine how vandetanib may work in people with kidney cancer and to develop tests          that may be helpful in studying kidney cancer.      Eligibility:      -Patients 18 years of age or older with advanced clear cell kidney cancer whose disease has     worsened after treatment with one or more of the following drugs: sunitinib, sorafenib,     interleukin-2 and temsirolimus; or patients who have had to stop treatment with these drugs     due to unacceptable side effects; or patients who are unable to receive standard treatment.      Design:        -  Patients take a vandetanib pill once a day in 28-day cycles.        -  Patients are followed in the clinic every 2 weeks during the first month of treatment          and then every 4 weeks for a physical examination, blood and urine tests,          electrocardiogram and a review of any drug side effects.        -  Patients have imaging scans (computed tomography (CT) or magnetic resonance imaging          (MRI)) about every 8 weeks to monitor tumor growth. MRI scans are also done to look at          tumor blood flow when treatment begins, 24 hours after the first dose of treatment, and          again about 4 and 8 weeks after starting treatment        -  Optional tumor biopsies (surgical removal of a sample of tumor tissue) may be done          before starting vandetanib treatment and after 4 weeks of treatment to look for drug          effects on the tumor.   "
146036|NCT01372800|"     Adiponectin (Ad) is an abundant protein in human body, and reports have shown that it act as     a novel risk factor for brain and heart ischemia injury. This 5 years follow-up study will     focus on serum adiponectin concentration, activity and isoforms in Chinese population and its     correlation to these diseases.   "
146037|NCT01372787|"     This clinical trial studies the quality of life and care needs of patients with persistent or     recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer. Studying quality of     life in patients with cancer may help determine the effects of gynecologic cancer and may     help improve the quality of life for future cancer survivors.   "
146038|NCT01372774|"     RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and     cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor     cells. It is not yet known whether stereotactic radiosurgery is more effective than     whole-brain radiation therapy in treating patients with brain metastases that have been     removed by surgery.      PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works     compared to whole-brain radiation therapy in treating patients with brain metastases that     have been removed by surgery.   "
146039|NCT01372761|"     The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and     effective.   "
146040|NCT01372748|"     The primary aim of the trial is to compare survival to hospital discharge after continuous     chest compressions (CCC) versus standard American Heart Association (AHA) recommended     cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients     with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the     rate of survival to hospital discharge is not affected by use of continuous compressions with     passive or positive pressure ventilation (intervention group) versus CPR with compressions     interrupted for ventilation at a ratio of 30:2 (control group).   "
146052|NCT01372592|"     The Spine TRACK Spinal Surgery Registry is a prospective multi-center observational data     collection initiative, to capture clinical and radiographic outcomes in candidates for spine     surgery with degenerative, deformity, and traumatic pathologies. As an observational     database, there are no initial driving hypotheses, but rather data will be mined to answer     unforeseen questions, but which may include broad topics such as comparative effectiveness     between and among various surgical treatment options, and/or outcomes in various subgroups of     patients such as defined by demographics, comorbidities, indications and symptoms, treatment     variables, and/or outcome variables.   "
146053|NCT01372579|"     This phase II trial studies how well giving eribulin mesylate and carboplatin together before     surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used     in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop     the growth of tumor cells, either by killing the cells or by stopping them from dividing.     Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal     tissue that needs to be removed.   "
146120|NCT01371708|"     This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate     Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major     Depressive Disorder (MDD).   "
146041|NCT01372735|"     The current standard treatment for patients with primarily resectable pancreatic tumors     consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable     group, long term survival is disappointing because of high local and distant failure rates.     Postoperative chemoradiation has shown improved local control and overall survival compared     to surgery alone but the value of additional radiation has been questioned in case of     adjuvant chemotherapy. However, there remains a strong rationale for the addition of     radiation therapy considering the high rates of microscopically incomplete resections after     surgery. As postoperative administration of radiation therapy has some general disadvantages,     neoadjuvant and intraoperative approaches theoretically offer benefits in terms of dose     escalation, reduction of toxicity and patients comfort especially if hypofractionated     regimens with highly conformal techniques like intensity-modulated radiation therapy are     considered.      Therefore the NEOPANC trial has been designed as a prospective, one armed single center study     to investigate a combination of neoadjuvant short course intensity-modulated radiation     therapy (5x5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy)     followed by adjuvant chemotherapy according to german treatment guidelines in patients with     primarily resectable pancreatic cancer. The primary objectives of the NEOPANC trial are to     evaluate the general feasibility of this approach and the local recurrence rate after one     year. Secondary endpoints are progression-free survival, overall survival, acute and late     toxicity, postoperative morbidity and mortality and quality of life.   "
146042|NCT01372722|"     Hypothesis to be tested:      Bilateral Deep Brain Stimulation to the Nucleus Accumbens is associated with clinically and     statistically significant improvement in patients with treatment resistant bipolar disorder.      Overall Objective:      The aim in this interdisciplinary, psychiatric-neurosurgical project is to evaluate safety     and efficacy of bilateral Deep Brain Stimulation to the Nucleus Accumbens (NAcc) using the     Medtronic Activa RC Neurostimulator in patients with treatment resistant Bipolar Disorder.   "
146043|NCT01372709|"     This is a prospective observational post-market study of subjects receiving the Ovation™ or     Ovation Prime™ Abdominal Stent Graft System (Ovation™ or Ovation Prime™ Abdominal Stent     Graft System Post-Market Study) in the treatment of abdominal aortic aneurysms (AAA). The     Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to     expand the clinical knowledge base by collecting data on subjects treated with the Ovation™     or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following     commercial approval.   "
146044|NCT01372696|"     The purpose is to investigate whether polyps that look different at colonoscopy, have formed     via different mutations and have different risks of turning into cancer.   "
146045|NCT01372683|"     This study is designed to test the hypothesis that on an equivalent calorie basis, oat based     breakfast cereals do not provide the same satiety benefit. The study will also demonstrate     the satiety comparison of the cereals related to product density.   "
146046|NCT01372670|"     The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment     of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with     an eating disorder who are underweight. The investigators want to find out if hydroxyzine     given before meals will improve meal-related anxiety compared to no hydroxyzine.   "
146047|NCT01372657|"     Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement     methods before and after cataract surgery improved formulas are tried be developed.   "
146048|NCT01372644|"     Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) increases breast     cancer risk. In post menopausal women, SERMS are standard chemopreventive agents. The     investigators have previously shown insulin-like growth factor-I (IGF-I) is required to     permit estrogen (E2) and progesterone action in the mammary gland, and that a novel     somatostatin analog, SOM230, that inhibits IGF-I action can prevent E2 action on the mammary     gland. It reduces cell proliferation and increases apoptosis (cell death) in the rat mammary     gland. This study was designed to determine whether women at high risk for breast cancer     respond to SOM230 in the same way that rats do. Methods: Women with atypical ductal     hyperplasia or lobular carcinoma in-situ by core biopsy were treated for 9.5 days with SOM230     (600mcg BID). Surgical excision was performed on day 10. Sections were examined before and     after SOM230 treatment for cell proliferation (Ki67) and apoptosis (TUNEL). Serum IGF-I,     fasting glucose, insulin, and HbA1C were measured in anticipation of changes.   "
146049|NCT01372631|"     The goal of this research is to further develop novel optical assay systems for intra     operative assessment of tumor margins in partial mastectomy or mastectomy specimens.   "
146050|NCT01372618|"     This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230)     in women with ductal carcinoma in situ (DCIS) of the breast. Surgery and radiotherapy are     used as treatment for DCIS and subsequent treatment with antiestrogens has been effective in     reducing the occurrence of invasive breast cancer. Unfortunately, treatment with     antiestrogens carries potential serious side effects and toxicities that are intolerable to     some patients. Preliminary data suggest that inhibition of IGF-1 action in the breast will be     at least as effective as tamoxifen. Pasireotide is a somatostatin analog that prevents     mammary development by inhibiting IGF-1 action directly in the mammary gland and also     indirectly without causing menopausal symptoms. This study is an expansion of work that we     have previously done in women with atypical hyperplasia of the breast, which showed that     treatment with pasireotide for 10 days caused a reduction in the cellularity of these     precancerous lesions. In our present study, women with DCIS will be treated with pasireotide     for 20 days prior to surgical excision. Endpoints will be as follows:        1. To determine whether pasireotide will inhibit cell proliferation and angiogenesis (signs          of tumor growth), and stimulate apoptosis (cell death) in surgically excised tissue in          comparison to core biopsies from women with estrogen receptor (ER) positive DCIS. Both          the core biopsy and surgical excision are standard of care procedures that women with          DCIS have regardless of participation in this trial.        2. To use dynamic contrast enhanced MRI to assess patients before and after treatment with          pasireotide and evaluate for changes in tumor volume and other tumor related features        3. In our previous study we found that many women experienced a slight elevation in blood          sugar with 10 days of treatment with pasireotide. Other work has shown that this effect          often resolves with greater duration of treatment. We are therefore expanding the          duration of treatment in this study to 20 days to assess if the initial hyperglycemia          seen with pasireotide improves as treatment duration progresses.   "
146051|NCT01372605|"     This project will integrate a depression treatment and brief medication adherence counseling     intervention into clinical care at three HIV clinics and will use a randomized controlled     trial to assess whether, relative to usual care, the intervention leads to improved HIV     medication adherence. The depression treatment intervention uses a model known as     Measurement-Based Care which equips Depression Care Managers with systematic measurement     tools, a decision algorithm, and psychiatric backup and trains them to provide decision     support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.   "
146054|NCT01372566|"     The goal of this study is to assess the safety, tolerability and effectiveness of platelet     rich plasma in the treatment of photoaged skin. This study will be divided into two parts.     The first part will assess the safety and tolerability of platelet rich plasma injections as     compared to sterile saline injections in subjects' arm with six months follow-up. The second     part will assess the effect of platelet rich plasma on the appearance of facial skin in a     split face study with platelet rich plasma injections on one side of the face and sterile     saline on the other. Outcomes will be recorded for twelve months.   "
146055|NCT01372553|"     -  Genomic medicine, using genetic information to improve health outcomes, is heralded as          the answer to rising medical costs by focusing on prevention and tailored care. Despite          its potential, little investigation has focused on how genomic medicine can be applied          in health care. To be effective, it requires new ways to learn, deliver, and communicate          medical information. It will also raise new ethical questions.        -  The overall goal of Guilford Genomic Medicine Initiative (GGMI) is to identify the          specific challenges in re-structuring an existing medical system to integrate genomic          medicine, and create solutions that can be used by other medical systems, such as the          extensive military medical care system. To accomplish this goal, GGMI includes the          development of a large-scale genomic medicine education initiative targeted at the          community, providers, and patients, and a clinical systems model to implement strategies          to facilitate the integration of genomic medicine into several pilot practices.   "
146056|NCT01372540|"     This study is divided into study groups, as described below. The goal of Groups 1A and 2A of     this clinical research study is to find the highest tolerable dose of the combination of     ARRY-520 and carfilzomib that can be given to patients with multiple myeloma or plasma cell     leukemia.      The goal of Groups 1B and 2B of this study is to learn if the combination of carfilzomib and     ARRY-520 can help to control multiple myeloma or plasma cell leukemia. Researchers would also     like to learn if ARRY-520 can help carfilzomib to work in patients who have built up a     resistance to carfilzomib or carfilzomib alone has not helped to control the disease.      The safety of the study drugs will be studied in all groups.   "
146204|NCT01370590|"     The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg     combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin     20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.   "
146057|NCT01372527|"     Although there is considerable evidence that current health IT can improve certain elements     of care, the most effective and efficient implementation of health IT systems for primary     care population management are not currently known. Indeed, while many systems currently take     a case-management approach to identify and address clinical care issues for high risk     patients, no systems to our knowledge apply a risk-based approach that accounts both for     adverse clinical outcome risk (e.g. breast cancer in a woman who has not had indicated     screening for 4 years) and for clinical process risk (e.g. the likelihood that a specific     patient will ignore a reminder letter and would therefore benefit from direct phone or in     person contact). The investigators propose to directly test the hypothesis that implementing     a health IT platform that 1) provides novel risk-based decision support using data derived     from the electronic health record (EHR) and 2) leverages each clinician's unique knowledge of     his or her patient panel will result in more effective and more efficient population-based     primary care. The investigators will test this hypothesis in a practice-randomized clinical     trial of preventive cancer screening within our primary care Practice-Based Research Network     (PBRN).   "
146058|NCT01372514|"     The purpose of this study is to create an institutional registry of Thromboembolic disease     through a prospective survey based on epidemiological data, risk factors, diagnosis,     prognosis, treatment, monitoring and survival.      The main goal is to describe the occurrence of thromboembolic disease and the characteristics     of clinical presentation, evolution and predisposing factors of these episodes in the     population of the Hospital Italiano de Buenos Aires.   "
146059|NCT01372501|"     The purpose of this study is to determine whether the GI Endobarrier Liner can be     reimplanted.   "
146060|NCT01372488|"     1. Hypothesis           If patients who are sutured with non-absorbable sutures in the Emergency Department (ED)          are provided with the proper equipment and knowledge on how to remove their own sutures,          they will be willing and capable of removing their own sutures.        2. Primary and Secondary Questions      Primary Question What number of patients in the study group will successfully remove their     own sutures if they are provided with the equipment and information on how to do so compared     with a control group who are treated and advised in the usual fashion? (follow up with family     doctor or local medical clinic for suture removal)      Secondary Questions        1. Number of complications related to self removal of sutures as compared to traditional          treatment. Complications measured were wound infections, dehiscence and prolonged          bleeding (>30 min)        2. Number of physician visits related to self removal of sutures as compared to traditional          treatment.        3. Patient satisfaction and comfort level related to self removal of sutures as compared          with traditional treatment.   "
146061|NCT01372475|"     Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a     new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS]     in subjects with symptomatic osteoarthritis of the knee.   "
146062|NCT01372462|"     Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive     Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe     Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during     constant work rate exercise in subjects with severe COPD.   "
146063|NCT01372449|"     This study will attempt to study the effect of memantine, on memory, and motor     praxis/expressive language skills in children with autism.      The investigators will recruit children ages 6-12 years who are verbal and meet criteria for     Autism Spectrum Disorder. The children will be assessed for memory function, expressive     language output and motor skills/praxis. They will then be randomized to memantine or placebo     for 6 months. The effects of this medication and its safety in this population will be     studied over the 6 month period.   "
146121|NCT01371695|"     The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated     sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical     Intraepithelial Neoplasia III (CIN III), and cervical cancer.   "
146064|NCT01372436|"     Identification of caries high risk subjects. Studying the relevance and the distribution of     caries risk factors as defined by the HAS, and the part played by the zone of schooling     (priority education area or not) Studying the interest of bacteriological tests using the     technique of real-time PCR and the laser fluorescence device in the caries risk assessment     Thanks to a prospective cohort study conducted over a period of 4 years on a representative     sample of pupils and students chosen at random from the 360 primary schools and 89 high     schools in the Alpes Maritimes (678 subjects).   "
146065|NCT01372423|"     The objective of this study is to evaluate the clinical equivalence and safety of the Test     formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA®     (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed     chronic idiopathic constipation.   "
146066|NCT01372410|"     The purpose of this study is to further characterize the dose response of GSK573719 at doses     of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary     disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to     further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the     Handihaler will be included as an active control. A placebo treatment will be included in     order to evaluate absolute treatment effect of the different doses of GSK573719.   "
146067|NCT01372397|"     The overall purpose of this study is to determine if weight loss is beneficial for obese     patients with diastolic heart failure.   "
146068|NCT01372384|"     This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients     with locally advanced, metastatic or recurrent non-small cell lung cancer who have not     received previous chemotherapy for their disease and who present epidermal growth factor     receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease     progression or unacceptable toxicity occurs.   "
146069|NCT01372371|"     Hypothesis: Directly applying antibiotic powder onto the site of surgery along with     perioperative intravenous antibiotics, before closing the wound, is more effective than     intravenously applied perioperative antibiotics alone in controlling post-operative wound     infection. The investigators also think powders that control both gram positive and gram     negative bacteria are more beneficial.   "
146070|NCT01372358|"     The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000 mg     ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation     in healthy, adult, non-smoking subjects under non-fasting conditions.   "
146205|NCT01370577|"     The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly   "
146072|NCT01372332|"     The purpose of this explorative study, targeting subjects with homonymous visual field loss,     is threefold:      (i) to identify the perimetric / psychophysical method, that is most closely correlated with     an individually assessed quality of life (QoL) score, using a validated questionnaire     (NEI-VFQ 25) (ii) to determine, whether gaze-related (exploratory eye movements) or visual     field-related (eyes steadily fixating) parameters are better for the characterization of the     visual capacities that are necessary for activities of daily living (ADL), as represented by     (iia) a standardized visual search task (supermarket special offer search task) (iib) by an     on-road car driving pilot study.   "
146073|NCT01372319|"     The purpose of this explorative study, targeting subjects with advanced binocular     glaucomatous visual field loss, is: (i) to identify the perimetric / psychophysical method,     that is most closely correlated with an individually assessed quality of life (QoL) score,     using a validated questionnaire (NEI-VFQ 25), (ii) to determine, whether gaze-related     (exploratory eye movements) or visual field-related (eyes steadily fixating) OR     attention-related parameters are better for the characterization of the visual capacities     that are necessary for activities of daily living (ADL), as represented (iia) by a     standardized visual search task and (iib) by an on-road car driving feasibility study.      Further this study is intended to introduce and analyse a novel diagnostic method for     recording and evaluating exploratory eye movements (gaze-related perimetry) in a clinical     setting. A similar procedure has recently been introduced by Murray et al. However, their     set-up is based on a video monitor and, therefore, restricted to the central visual field     (eccentricity < 25°) and limited with regard to the dynamic range of the stimulus luminance.     Since our new gaze-related perimetry is designed to be implemented in a conventional cupola     perimeter, it should be widely available as a potent diagnostic tool, for screening purposes,     or for clinical surveys by general ophthalmologists or clinical research groups.   "
146074|NCT01372306|"     Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.   "
146075|NCT01372293|"     An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify     for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has     been suggested in previous studies.      Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors,     the investigators hypothesis is that women with PCOS and with the variant allele G have a     poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive     pill (OCP) treatment for 6 months.   "
146076|NCT01372280|"     Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting     condition.   "
146101|NCT01371955|"     The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the     investigators choose to look about some oxidative stress genes. Today a one-gene explanation     is not really possible. So the theory of some genetic predisposition to DN is more likely.      The aim of the study is to look about the association of the C282T polymorphism of P22phox, a     sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the     occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also     investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation     end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX     12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last     polymorphism is correlated to albuminuria in diabetic patients.   "
146137|NCT01371474|"     The objective of this survey was to understand the safety and efficacy of PAXIL tablets     (PAXIL, hereinafter) when it was started at 20 mg/day in subjects with depression or in a     depressed state.   "
146077|NCT01372267|"     The present intervention is a Stage II randomized controlled efficacy trial of a group-based     intervention that integrates Cognitive Behavioral Therapy (CBT) for pain and substance use     disorders (SUDs) compared to a Supportive Psychoeducation Control (SPC) group in a sample of     patients receiving residential SUD treatment with co-occurring chronic pain. A total of 452     patients (226 male and 226 female) with current pain rated as moderately severe or greater     and comorbid drug or alcohol use disorder(s) will be recruited from a large residential SUD     treatment program. These participants will be randomly assigned to either a 4-week     (8-session) group of integrated CBT for pain and SUDs or a 4-week (8-session) SPC group. All     participants will be re-assessed immediately post-treatment (1 month) and again at 3, 6, and     12 months post-intervention. Through this randomized controlled trial, the investigators hope     to gain insight on how to improved treatment of pain in those with SUDs that could result in     enhanced quality of life and improved pain-related, substance use, and other health outcomes.     Evaluating a psychosocial intervention for pain and substance use that can be delivered     during a SUD treatment episode would significantly extend available treatment options for the     large numbers of patients with pain seen by SUD treatment providers. The investigators also     hope to determine the efficacy of an evidence-based psychosocial pain management approach in     men and women from a large and diverse residential addiction treatment program.   "
146078|NCT01372254|"     The objective of the proposed project is to develop a novel, behavioral approach to smoking     cessation that can be integrated with residential drug use treatment for low income substance     using smokers with elevated depressive symptoms. The approach utilizes behavioral activation     strategies which have been shown to reduce smoking among community samples and which can be     easily targeted for the particular needs of low income substance users.   "
146079|NCT01372241|"     The purpose of this study is to determine whether a faith-placed lay health advisor     intervention is effective in increasing use of Pap smears among middle-aged and older     Appalachian women.   "
146080|NCT01372228|"     The goal of this research study is to establish chimerism and avoid graft-versus-host-disease     (GVHD) in patients with inherited metabolic disorders.   "
146081|NCT01372215|"     In this study, participants, who are scheduled to have a breast biopsy, will have several     extra spot mammogram images taken of the suspicious area. These images will be acquired with     varying levels of compression. The images will then be analyzed to determine whether the type     of lesion (malignant or benign) can be determined from the image data alone. The biopsy     results will be used as a gold standard to determine the true malignancy status   "
146082|NCT01372202|"     This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum     Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status     in Diagnostic Biopsies.   "
146083|NCT01372189|"     The study aims to:        1. Achieve molecular imaging of EGFR in patients with colorectal neoplasia in vivo using          confocal laser endomicroscopy.        2. Compare the results of in vivo EGFR-specific molecular imaging with CLE and ex vivo          immunohistochemistry .   "
146084|NCT01372176|"     An increasing number of patients survive critical illness and intensive care, but describe     having impaired physical function several years after discharge as a consequence of extensive     loss of muscle mass. Reasons for loss of muscle mass and physical function are multiple, but     insufficient nutrition is likely to contribute.      This randomised trial will investigate the effect of an optimised nutrition therapy during     intensive care, on short term clinical outcome and physical quality of life. We hypothesise,     that early nutritional therapy, directed towards patient-specific goals for energy and     protein requirements, will improve both short- and long-term outcomes.   "
146089|NCT01372111|"     Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for     treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC),     though many clinical questions remain. Prior experience has revealed locoregional control     (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after     treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and     concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This     multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL)     and toxicity profile. The current trial is an attempt to maintain high LRC, while further     minimizing both acute and chronic toxicities, and maximizing QOL.   "
146090|NCT01372098|"     The purpose of this study is to determine whether the Intimate Partner Violence (IPV)     intervention in the context of Nurse-Family Partnership (NFP) program improves women's     quality of life and reduces violence relative to the NFP alone using a cluster randomized     controlled trial. Our hypothesis is that an IPV intervention can be designed that is     acceptable to participants in the NFP, feasible to implement, and that this intervention will     improve quality of life for women and reduce exposure to violence.   "
146091|NCT01372085|"     This is a single-centre, placebo-controlled, two-part study in healthy subjects.      Part A will be a single dose, single period, placebo-controlled pilot study to explore the     safety, tolerability, absorption and pharmacodynamic (effect of drug on a biological     marker-pS6 levels in skin biopsies) of a single dose of 25 mg LY2584702 Reference formulation     (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily     evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of     LY2584702.   "
146092|NCT01372072|"     Noninvasive ventilation (NIV) is a form of ventilation delivered by a mask and is an     important mode of treatment in patients with both acute and chronic respiratory (breathing)     failure. Humidification is widely accepted as an essential part of the ventilation strategy     in patients receiving invasive ventilation (i.e. via a tube inserted into the mouth), but its     role during NIV use is not proven. Consequently, there is a variation in practice with regard     to humidification during NIV. Humidification is important in maintaining upper and lower     airway mucosal function and patients requiring NIV often report symptoms, such as throat     dryness, due to a lack of airway humidity. Success of NIV in the acute setting is dependent     on many factors including, patient tolerance of NIV during the acute phase. In patients with     chronic obstructive airways disease (COPD), poor tolerance results in NIV failure, which     necessitates endotracheal intubation or treatment failure. Furthermore, invasive ventilation     increases the risk of a hospital acquired pneumonia, which is associated with a worse     outcome. In the long term setting of NIV use, again patients frequently report symptoms due     to drying of the airways and adherence to NIV can be highly variable. Adherence in these     patients is important in improving both quality and length of life. Humidification devices     may be technically effective, but clinicians have concerns regarding potential negative     effects of these devices. There is a requirement to evaluate the use of humidification in     both the acute and long term use of NIV, particular, in terms of patient ventilator     interaction, which will impact on comfort and adherence to NIV. This will effect the overall     effectiveness of ventilation. The investigators propose a randomised controlled trial to     investigate the effects of a humidification system during noninvasive ventilation.   "
146093|NCT01372059|"     The initiative to the study is based on the fact that various forms of enriched environments     and multimodal stimulation are found to have positive influences on motivation and     psychosocial well-being and have been shown to facilitate multiple processes in the brain     leading to structural regeneration and functional recovery. Since there is a lack of     rehabilitation programs that encompass all dimensions of a stroke survivor's life researchers     agree upon the need for a rehabilitation program that addresses both the social and physical     needs of the patients. The aim with the project is to investigate whether it is possible to     improve the life situation among patients with a history of stroke through a rhythm and music     method and therapeutic riding. To get insights in the underlying mechanisms our research also     focuses on relevant physiological, neurobiological and psychosocial mechanisms induced by the     interventions. The hypothesis is that both treatment methods will mainly enhance     participants' degree of participation.      The study is a randomized controlled trial where about 123 participants (50-75 years old) who     had their stroke incident 1 - 5 years ago will be consecutively included and randomly     allocated to the following three groups: a) Ronnie Gardiner Rhythm Music Method (RGRM) b)     therapeutic riding c) a control group receiving RGRM after 9 months. Treatment proceeds     during 12 weeks and evaluation takes place pre- and post intervention, and 12 and 24 weeks     after the treatment is finalized. The evaluation consists of a thorough neuropsychological     assessment, a physiotherapeutic assessment, sampling of blood and questionnaires covering     mental, psychosocial, physical and psychological well-being. Interviews are also conducted in     order to map the participants' experiences from the two treatment programs. Specially     designed interviews are also planned to be carried through with participants having aphasia.      So far, there is only empirical support suggesting that RGRM has positive effects for     individuals with a history of stroke making it significant to carry out research with the aim     to contribute to strengthening the evidence of the method. A positive outcome would increase     the scientific basis for this alternative treatment thus facilitating further research and     implementation in everyday clinical practice.   "
146094|NCT01372046|"     1. Assess the impacts of implementing a juvenile assessment, referral, placement, and          treatment planning (J-ARPP) protocol, and of different strategies for transferring          J-ARPP technology, on service utilization of youth entering the juvenile justice system.        2. Assess the impacts of implementing J-ARPP, and of different strategies for transferring          J-ARPP technology, on measures of organizational readiness and motivation, and staff          attitudes about assessment and service.        3. Assess the impacts of implementing J-ARPP, and of different strategies for transferring          J-ARPP technology, on measures of systems integration.        4. Assess fidelity to the J-ARPP protocol and the relationship between fidelity to the          J-ARPP protocol and service utilization of youth entering the juvenile justice system.   "
146095|NCT01372033|"     The specific aims of this project are:        1. To conduct a randomized block experiment to test the effectiveness of different models          of the seamless supervision/treatment system and traditional criminal justice          supervision on reducing recidivism and drug use, and improving social adjustment among          offenders;        2. To understand the differential impacts based on offender risk factors (e.g., propensity          to engage in further criminal behavior) on criminal justice outcomes and to determine          whether differences found between seamless and traditional system participants are          moderated by offender risk level;        3. To understand differential treatment and social adjustment outcomes (e.g., treatment          progress, employment status) of different types of offenders participating in various          treatment services; and        4. To examine levels of systems and service integration between the supervision and          treatment systems pre- and post-intervention and to measure the impact of integration on          outcomes over time.   "
146096|NCT01372020|"     The use of neuromuscular electrical stimulation in the treatment of venous ulcers with     difficulty of repair could be an alternative therapeutic favoring devitalized tissues and     hence the pain.      The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on     pain and area of venous ulcers in patients with venous insufficiency.   "
146223|NCT01370343|"     The primary purpose of this study is to evaluate the pharmacokinetics, safety and     tolerability of a single dose of PF-04991532 in healthy adult subjects with and without     co-administration of cyclosporine.   "
146097|NCT01372007|"     Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal     lymph nodes within the mesorectal envelope. It is becoming universally recognized and     accepted as the standard technique for surgical excision of rectum carcinomas. TME results in     lowest rates of local recurrence, especially when combined with pre-operative     chemo-radiotherapy.      Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be     important. The quick decrease of this drainage will enable the early mobilisation of the     patient and may shorten the time of hospitalization. If this decrease in fluid production can     be achieved, it will have a positive effect on the Quality of Life of the patient and will     ensure health economic savings by reduction of hospitalization time and resources.      Somatostatin analogues have shown to be able to decrease the secretion of numerous types of     bodily fluids.      The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the     fluid discharge in patients that underwent a TME for rectumcarcinoma.      Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid     discharge in the drain of the patient that underwent a total mesorectum excision (TME) for     rectal carcinoma. Patient planned to have a TME will be asked to participate in the study.     When they have provided written informed consent, they will be randomized 1:1 to receive     either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily     post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication or placebo     will be administered. After administration the volume of the drain fluid will be measured     every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24     hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride     analysis afterwards. If the patient has a hematocrit >10% in his drain fluid for a period of     5 days, this patient can not be randomized.   "
146098|NCT01371994|"     The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of     solifenacin succinate versus placebo in participants who are incontinent after Robotic     Assisted Radical Prostatectomy.      This study will also assess the effect of 12 weeks of treatment with solifenacin succinate     versus placebo on quality of life (QOL) as measured by questionnaires.   "
146099|NCT01371981|"     This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in     treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib     tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell     growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells,     either by killing the cells or by stopping them from dividing. Giving bortezomib and     sorafenib tosylate together with combination chemotherapy may be an effective treatment for     acute myeloid leukemia.   "
146100|NCT01371968|"     This study aims to determine the optimal dose of alfentanil in suppressing the airway     reflexes during supreme LMA removal in anaesthetized adult.   "
146115|NCT01371773|"     The purpose of this study is to devise repositioning method of a left-sided double lumen tube     into left mainstem bronchus in case of misplacement into right mainstem bronchus.   "
146116|NCT01371760|"     To assess in a double blinded randomized control trial (RCT) study design safety and     effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in     multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).      Mean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be     randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.   "
146102|NCT01371942|"     The aim of this study is to investigate mutational changes occurring in colorectal tumors,     from benign polyps, malignant cancer and metastatic tumors. The investigators also plan to     establish the clinical correlation, emphasizing on aspects such as the diagnosis and     prognosis of disease and the specific treatment outcome. For the purpose, the investigators     plan to obtain specimens from patients with colorectal tumors to extract DNA material. The     specimens include tissues from either primary (mostly endoscopic biopsies specimens) or     metastatic tumors (obtained from sonogram or other imaging modalities guided biopsy), as well     as other humors including blood (for serum), malignant ascites, pleural effusions or other     body fluids that could be related to CRCs. These patients would receive detailed explanations     with regard to the investigations before signing IRB consent. At the initial stage, Wanfang     Medical Center would be the only medical institution where endoscopic specimens would be     collected. The project would eventually be extended to the Taipei Medical University Hospital     and Shuan-Ho Hospital.   "
146103|NCT01371929|"     The primary objective is to demonstrate that the plasma inducible nitric oxide synthase     (iNOS) assay (PliNOSa® test) has an acceptable relative risk ratio for predicting the onset     of sepsis within 72 hours of testing when performed on the first day a patient is admitted or     transferred to the intensive care unit (ICU) and is considered to be at risk of becoming     septic. The PliNOSa® test measures inducible nitric oxide synthase (iNOS) in plasma and uses     a pre-determined iNOS cut-off value to identify patients at risk for the onset of the sepsis     pathology.   "
146104|NCT01371916|"     Early and reliable diagnosis of tuberculous meningitis (TBM) still poses a great challenge.     One of the underlying difficulties is due to the fact that tubercle bacilli are mainly not     present in the cerebrospinal fluid (CSF) but in the phagocytotic macrophages. The present     study was designed to demonstrate early secretory antigenic target 6 (ESAT-6), a     mycobacterium-specific antigens, in the macrophages in infected CSF samples and compare the     efficiency of this antigen in the laboratory diagnosis of TBM.   "
146105|NCT01371903|"     Emergency department patients receiving opioid pain medicine such as morphine, fentanyl or     Dilaudid are eligible. After medication exhaled carbon dioxide is measured. and recorded.   "
146106|NCT01371890|"     The purpose of this study is to determine the role of dialysate exposure and fluid removal     during hemodialysis in the pathophysiology of intradialytic hypertension.   "
146107|NCT01371877|"     This clinical study was designed based on our hypothesis that vitamin D plays an important     role in chronic urticaria and that high dose supplementation with vitamin D in subjects with     chronic urticaria will improve clinical response.      This clinical study will investigate our hypothesis in three Specific Aims:        1. Determine whether high dosing vitamin D supplementation (4000 IU/day) reduces medication          usage (primary outcome) and urticaria severity score (secondary outcome) in subjects          with chronic urticaria as compared to low dosing (600 IU/day).        2. Determine if high dosing of vitamin D (4000 IU/day) is safe and well-tolerated in          subjects with chronic urticaria with or without baseline vitamin D deficiency.        3. Investigate whether there is an association with serum 25-hydroxyvitamin D levels,          vitamin D receptor mRNA expression, and chronic urticaria severity.   "
146224|NCT01370330|"     This is a compassionate use protocol to allow patients with advanced neuroblastoma palliative     access to 131I-metaiodobenzylguanidine (131I-MIBG).   "
146109|NCT01371851|"     Psychostimulant dependence is a major public health problem and no medications have been     shown to be very effective in treating this disorder. Thus, the investigators wish to study     whether a blood pressure drug thought to reduce drug craving through its interaction at     particular adrenergic receptors - doxazosin - can dredge cocaine use relative to placebo in     psychostimulant dependent participants enrolled in an 8-week, randomized, double blind,     placebo-controlled outpatient clinical trial. Our hypothesis is that doxazosin will reduce     cocaine use relative to placebo in psychostimulant dependent participants.   "
146110|NCT01371838|"     This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline     Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With     Community-Acquired Bacterial Pneumonia in Asia.   "
146111|NCT01371825|"     This is an open-label, repeat-dose, intra-subject dose escalation study of SBC-102 (USAN:     sebelipase alfa) in children with growth failure due to LAL Deficiency. Eligible subjects     will receive once-weekly (qw) infusions of sebelipase alfa for up to 5 years   "
146112|NCT01371812|"     The purpose of this first time into human study is to investigate the safety, tolerability,     pharmacokinetics and pharmacodynamics of GSK2239633 in healthy male subjects.   "
146113|NCT01371799|"     This will be a double blind, randomised, placebo controlled, cross over study in which up to     20 otherwise healthy male nicotine abstinent smokers will be tested following 3 acute     treatment conditions (placebo, 4 and 8mg of GSK1034702). Each subject will undergo screening     assessments within 30 days prior to administration of the first dose of study medication.     There will be 3 treatment sessions and dosing will be separated by a minimum 1 week washout     period. There will be two testing days (day 1 and day 2) per treatment session. On each     treatment session subjects will be admitted on day 1. On day 1, subjects will be administered     placebo and approximately 3 hours later, there will be a Baseline EEG/ERP recording,     neuropsychological (Cogstate battery) testing and mood/craving/dependence questionnaire     assessments . Subjects will be allowed to smoke until approximately midnight on day 1. On day     2, subjects will undergo a pre-drug neuropsychological (Cogstate battery) testing and     questionnaire assessments of mood/craving. This will be conducted approximately 1 hour prior     to dosing. Subjects will be randomized to one of six treatment sequences. Post dose EEG/ERP     recording, neuropsychological (Cogstate battery) testing and mood/craving measurements will     be conducted between 3 and 6 hours post treatment to coincide with peak pharmacokinetic     effects. This testing will be performed approximately at 12pm following at least 12hrs of     nicotine abstinence. Blood samples will be collected at baseline (pre-drug) and following     drug administration to quantify exposure levels.   "
146114|NCT01371786|"     This study is an open label, single dose, single site, randomized, cross over study that will     assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide     radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone     furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14     patients with symptomatic allergic rhinitis, aged 18-65 years.   "
146122|NCT01371682|"     This is an open-label, randomised, two-period crossover, single dose study to demonstrate     bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two     different sites in healthy subjects. Dosing will be under fasting conditions and there will     be a minimum one week washout between doses. Domperidone will be administered to control     dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety     assessments will include screening and follow-up vital signs, ECGs and safety laboratory     tests. Vital signs and adverse events will be monitored periodically throughout the study.   "
146123|NCT01371669|"     In the investigators study, and regarding results of small cohorts in the literature, the     investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators     will explore these patients with a one night polysomnography and transcutaneous capnography,     searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.   "
146124|NCT01371656|"     This randomized phase III trial studies how well levofloxacin works in preventing infection     in young patients with acute leukemia receiving chemotherapy or undergoing stem cell     transplant. Giving antibiotics may be effective in preventing or controlling early infection     in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It     is not yet known whether levofloxacin is effective in preventing infection.   "
146225|NCT01370317|"     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose     treatment with MK-1029 in adults with mild to moderate persistent asthma.   "
146125|NCT01371643|"     This is a randomized, multicenter trial with stratification done by a single radiologist at     the coordinating center (NYU), and patients with comparable disease will be randomized to     Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before     (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo     transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to     Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine     whether surgery (debulking of pituitary adenomas) improves the response of patients with     acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.   "
146126|NCT01371630|"     The goal of the Phase I part of this clinical research study is to test 2 dose levels of the     drug inotuzumab ozogamycin to find the highest tolerable dose that can be given in     combination with chemotherapy. The goal of Phase II is to learn if inotuzumab ozogamycin     given in combination with chemotherapy can help to control acute lymphoblastic leukemia     (ALL). The safety of the study drugs will also be studied.      Participants in this study are at least 60 years of age and have newly diagnosed ALL or have     refractory-relapsed ALL regardless of age.      Inotuzumab ozogamycin is designed to attach to a protein that is often found in leukemia     cells. This may cause the cancer cells to die.      Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to     die.      Hyper-CVD includes a combination of cyclophosphamide, vincristine, dexamethasone,     methotrexate, Ara-C (cytarabine), and Neulasta (pegfilgrastim). The maintenance therapy used     in this study is called POMP, which includes a combination of mercaptopurine, methotrexate,     vincristine, and prednisone. These chemotherapy drugs are designed to interfere with the     multiplication of cancer cells, which may slow or stop their growth and spread throughout the     body. This may cause the cancer cells to die.   "
146127|NCT01371617|"     The purpose of this study is to determine the safety and efficacy of IPI-926 in patients with     myelofibrosis (MF) (primary myelofibrosis [PMF], post-polycythemia vera myelofibrosis     [post-PV MF], or post-essential thrombocythemia myelofibrosis [post-ET MF]).   "
146128|NCT01371604|"     The purpose of this study is to assess the safety and antiviral activity of IDX184 in     combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype     1 chronic hepatitis C virus (HCV) infection.   "
146129|NCT01371591|"     The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED     patients with suspected upper GI hemorrhage. A prospective multicenter randomized control     trial was designed to investigate the safety of this approach.   "
146130|NCT01371578|"     This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response     Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451)     with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic     Genotype 1 Hepatitis C Virus (HCV) Infection.   "
146131|NCT01371565|"     This is a compassionate use study. In addition to providing compassionate use access to     mifepristone, objectives of the study will be to evaluate the safety and utility of     mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when     given on a compassionate use basis. The study will only enroll subjects whose physicians have     determined that medical treatment is needed to control the symptoms or signs of     hypercortisolemia.   "
146132|NCT01371552|"     The purpose of this study was to compare a new daily disposable, silicone hydrogel contact     lens to marketed daily disposable, silicone hydrogel contact lenses.   "
146133|NCT01371539|"     The purpose of this study was to compare visual performance measures between two multifocal     contact lenses on presbyopic wearers.   "
146134|NCT01371526|"     Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune     attack progressively destroys the adrenal cortex. Untreated it is universally fatal and     treated people are absolutely dependent upon steroid medications lifelong, with a consequent     excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are     responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This     study aims to regenerate adrenocortical steroidogenic cell function in patients with     established autoimmune Addison's disease (AAD) by stimulating proliferation and     differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using     daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we     will investigate whether regeneration of adrenal steroidogenic function through revival of     ACSC activity is a realistic possibility.   "
146135|NCT01371513|"     This is to investigate Korean urologist's practice patterns for screening prostate cancer     according to PSA level.   "
146136|NCT01371487|"     The purpose of the this study is to evaluate the effect of a high-fat, high calorie meal on     the single dose PK of GSK1120212 in subjects with solid tumors.   "
146138|NCT01371461|"     Overall improvement, severities and changes of specific clinical symptoms were surveyed in     outpatients with depression or in a depressed state to evaluate the efficacy and safety of     PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a     constant dose.   "
146139|NCT01371448|"     This surveillance study is designed to detect adverse events (particularly clinically     significant adverse drug reactions) occurring in clinical settings and to examine factors     likely to affect the safety and efficacy of paroxetine in long-term use (1 year).   "
146140|NCT01371435|"     This post-marketing surveillance study is designed to detect adverse events (particularly     clinically significant adverse drug reactions) occurring in clinical settings and to examine     factors likely to affect the safety and efficacy of paroxetine.   "
146141|NCT01371422|"     This is a randomized control trial (meaning the selection is random as when flipping a coin)     to assess the benefit of paravertebral blockade (PVB) in Percutaneous     nephrolithotomy/nephrolithotripsy (PCNL) surgery.   "
146294|NCT01369420|"     The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low     Energy Direct Current (LEDC) System when used to treat unresectable pancreatic     adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including     serious adverse events, laboratory data, physician exam findings, and vital signs.   "
146142|NCT01371409|"     After a stroke the excitability of the brain decreases on the stroke side and increases on     the opposite, non-stroke side. These changes make use of the stroke-affected arm difficult     and slow recovery. Rehabilitation exercises that increase arm use after stroke help increase     brain excitability, but the net effect of this approach is low. New therapies are needed that     restore more equal levels of brain excitability between the two sides. Brain stimulation is a     noninvasive way to affect activity the excitability of brain cells. Pairing brain stimulation     with exercises that require patients to learn new movements may help the brain to learn.     Using stimulation that reduces activity in the side opposite to the stroke can increase     activity on the stroke -affected side, through connections between the two brain hemispheres.     The purpose of this study is to test if brain stimulation on the side opposite to the stroke,     paired with arm movement exercises, can help patients learn new arm movements and improve arm     function.      In this study people with stroke will receive brain stimulation over two different areas on     the side of the brain opposite to the stroke: 1) those areas responsible for movement and 2)     those responsible for sensation. These experiments will test both the short and long term     effects of brain stimulation on patients' learning and arm function and will allow us to     identify which area of the brain best improves learning and arm function. These experiments     have the potential to improve the effectiveness of rehabilitation after stroke. The proposed     study is among the first to test stimulation over the side of the brain opposite to the     stroke damage and at multiple sites. This unique approach may help stimulate the development     of new methods for stroke rehabilitation.   "
146143|NCT01371396|"     The purpose of this study is to understand why Hispanics who are overweight have a higher     incidence of fatty liver disease.   "
146144|NCT01371383|"     The first part is a double-blind placebo-controlled trial to identify the effects of omega-3     polyunsaturated fatty acids (PUFAs) monotherapy in depression. The second part is a     double-blind trial to identify the effects of eicosapentaenoic acid (EPA) and docosahexaenoic     acid (DHA) on different symptom clusters in patients with depression.   "
146145|NCT01371370|"     -  Obesity is a major risk factor for premature arterial abnormalities including high blood          pressure and increased stiffness. Previous studies have shown that weight loss via          lifestyle modifications is associated with a decrease in large artery (aorta) stiffness.          However, along with decreases in fat mass, hypocaloric diet reduces muscle mass.          Low-intensity resistance exercise training (LIRET) results in similar increases in          muscle mass and strength than those observed after high-intensity resistance exercise.        -  The investigators hypothesis is that weight loss via diet combined with LIRET would          additively reduce arterial stiffness and blood pressure (BP) in obese women. The          investigators also hypothesize that the improved arterial function with weight loss          would be associated with beneficial changes in the main mechanisms involved in BP          regulation.   "
146146|NCT01371357|"     A methyl-group acceptor such as guanidinoacetic acid (GAA) could induce hyperhomocysteinemia     with the effects of GAA expected to be dose-dependent. Due to the fact that     hyperhomocysteinemia is thought to be an independent risk factor for cardiovascular and     neurodegenerative diseases, different dietary agents were used in the past for the treatment     of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or     folic acid. In the context of GAA loading the question arises whether intake of betaine,     choline (betaine precursor) or folic acid during GAA loading could affect plasma T-HCy in     healthy humans. Forty healthy physically active men and women aged 20 to 30 years will take     part in this GAA-controlled, double-blind and parallel-group intervention study. Subjects     will be allocated to four randomly assigned trials, with treatment lasting for 8 weeks and     washout period of 28 days. The 4 test treatment-groups will include TEST1 (GAA only), TEST2     (GAA, choline, B6, B12 and folic acid), TEST3 (GAA, betaine, B6, B12 and folic acid) and     TEST4 (GAA, B6, B12 and folic acid). Plasma T-HCy will be the primary outcome measure     assessed every second week throughout the study. Plasma B-vitamins and blood and urine     metabolites (GAA, creatine, methionine, arginine) will be secondary outcome measures along     with adverse-effects indicators assessed every second week throughout the study. Selected     body composition indicators will be obtained at 0, 2, 8 and 12 weeks throughout the study to     monitor the effects of experimental treatments on body hydration and protein synthesis. This     research will test the hypothesis that a combination of GAA with homocysteine lowering     nutrients attenuates the elevation of T-hcy, and will further display the size-effect of each     additive used.   "
146147|NCT01371344|"     The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and     effective Modigraf® is (Part A) and to see how safe and effective it is to change your     child's medication from Modigraf® to Prograf® (Part B).   "
146148|NCT01371331|"     The purpose of this study is to find out how much of Modigraf is absorbed and used in the     body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide     how much Modigraf in future can be given safely to children and young people following     transplantation.   "
146149|NCT01371318|"     The purpose of this study is to determine whether using the OWEMR as part of the standard of     care for Diabetic Foot Ulcers reduces the rate of lower limb amputations and to quantify the     relationship between glycemic control and the rate of amputation secondary to chronic foot     ulcers in Type II Diabetes.   "
146150|NCT01371305|"     The primary objective of this study is to evaluate the safety and tolerability of     subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized     monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as     STX-100) in participants with IPF. The Secondary objectives are to estimate the     pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple,     escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011     in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from     bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.   "
146151|NCT01371292|"     The purpose of this Randomized Controlled Tria (RCT) is to evaluate the effects of a     transformational teaching intervention in comparison to 'standard educational practices'     within school-based physical education classes (within three Canadian provinces; British     Columbia, Ontario and Nova Scotia) across 5 months.   "
146152|NCT01371279|"     This is a 2- component, single center study, witch aims to evaluate the efficacy of multisite     intracardiac echocardiography (mICE) imaging of left atrial appendage (LAA) and in detecting     thrombus located in LAA as compared to transesophageal echocardiography (TEE). The study     group will consist of patients eligible for atrial fibrillation (AF) ablation procedure     (Component I) or cardioversion (Component II).      First component will enroll 100 patients; these patients will undergo clinically indicated     TEE & cardiac catheterization procedures with ICE(AF ablation). Second component will enroll     15-20 patients with AF or atrial flutter in whom a thrombus in LAA was detected by TEE prior     to electrical cardioversion. The ICE probe will be located in multiple positions in the right     atrium (RA), coronary sinus (CS), pulmonary artery (PA), right ventricular outflow tract     (RVOT) and esophagus. This will enable the investigators to compare sensitivity and     specificity of mICE and TEE.      This study will examine two hypotheses in AF patients undergoing invasive cardiac procedures:      Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of LAA from multiple     positions (RA,CS,PA,RVOT and esophagus ). This will be evaluated during the component I of     the study.      Hypothesis 2: That ICE can identify low risk patients, CHADS Score < 2,0 in whom immediate     cardioversion during the procedure is as safe as based on conventional strategy.   "
146153|NCT01371266|"     Honey has been used as a sweetener for centuries. Recent data indicate that honey consumption     may have beneficial effects upon glucose intolerance, a health issue currently affecting 57     million Americans of every age and ethnicity. In order to evaluate the glycemic effect of     honey, the investigators will carry out a human trial assessing biomarkers of blood glucose     responses, insulin sensitivity, oxidative stress, and inflammatory markers. Our primary     objective is to determine the glycemic effects of honey in comparison to sucrose and high     fructose corn syrup (HFCS). The investigators hypothesize that honey will promote improved     glucose tolerance and insulin sensitivity compared to both sucrose and high fructose corn     syrup in normal glycemic and glucose intolerant adults.   "
146154|NCT01371253|"     On a yearly basis roughly 40.000 individuals aged 65+ contact the emergency departments in     Denmark as a result of an accidental fall, and in about 30% of these cases hospitalization is     required. The cost of these admissions vary according to the type of injury with hip     fractures being the most expensive accident {{113 Chrischilles,E. 1994; }}. The total average     cost of a severe hip fracture in the Danish healthcare system resulting in nursing home     placement has been estimated to approximately 365.000 Danish Kroner (Dkk) per year {{288     Christensen,P.M. 2005;}}. In addition, about 20 % of the elderly individuals who sustain a     hip fracture will die within 6 months {{200 Brot,C. 2006; }}. For the society the outcome of     falling in the elderly population is therefore not only associated with severe human but also     economical consequences. Hence, it is essential to refine, develop and think out of the box     when future intervention programs are designed and employed in the elderly community.      One such out of the box intervention could be balance training with a Nintendo Wii Fit     board (Nintendo Wii, Nintendo Co Ltd, Minami-ku Kyoto, Japan). The Nintendo Wii Fit board is     a new generation of computer game which uses 3D tracking of the participants' motion and     gestures. This means that the user interacts in and controls elements of the 3D gaming world     with their own body {{307 LaViola,J.J.,Jr 2008;}}. In the case of the Wii Fit board, it     detects the body sway and center of pressure (COP) of the participant and displays it onto a     TV screen in different balance sceneries. A virtual character on the TV then reacts according     to the user's movement and gesture (ex. skiing down a ski slope passing thru gates). This     enables the user to perform tasks that, they may not be able to execute safely or at all in     real-world situations. Interestingly in this context a study by Sihvonen et al from 2004     showed a compliance of 97,5% using the same technique as the Wii Fit only in 2D and with a     poor graphical display. Further, the Sihvonen-study showed that 2D biofeedback intervention     of only 4 weeks proved successful in terms of improved postural balance, physical activity     and life quality {{297 Sihvonen,S. 2004;}}. Finally, traditional methods when promoting     physical activity in the elderly population has been limited by lack of motivation or poor     compliance (REFS), which possibly has prevented the elderly from reaching a maximum     rehabilitation potential(REFS). Furthermore, in the follow-up period after these traditional     intervention studies, it has been documented how difficult it is for the elderly to sustain     the same training volume on themselves (REFS).      Virtual reality systems like the Nintendo Wii Fit have been developed specifically for     rehabilitation of the upper- {{301 Kuttuva,M. 2006;300 Dvorkin,A.Y. 2006;}} and     lower-extremities and gait training {{298 Deutsch,J.E. 2007;}}. Further virtual reality     platforms have been use for rehabilitation and training of reaching movements {{302 Piron,L.     2001;}}, motor coordination {{303 Broeren,J. 2002;}}, hand strength and range of motion,     speed of hand movement{{304 Jack,D. 2001;305 Merians,A.S. 2002;}}. But so far most of these     systems have not become commercially available possible due to a very high cost {{294     Deutsch,J.E. 2008;}}. Moreover in some cases the virtual rehabilitation environment has to be     constructed from scratch making the hole process and implication very complicated {{306     Weiss,P.L. 2004;}}. Thus, designing an intervention program that utilizes the low-cost     ready-to-use Wii Fit platform could be a possible research direction to explore. At the     moment few studies have been conducted using the Nintendo Wii console. Among the few some     have investigated the energy expenditure in kids (11-17 years of age) playing Wii Sports     (bowling, tennis and boxing) compared to sedentary xbox games and actual bowling, tennis and     boxing {{ 295 Graves,L.E. 2008; 296 Graves,L. 2008; }} while others have explored the     Nintendo Wii console for rehabilitation of an adolescent with cerebral palsy {{294     Deutsch,J.E. 2008; }}.      To the authors knowledge no studies have investigated the effect of 10 weeks of Nintendo Wii     Fit balance training in seniors (+65 years). The main purpose of the study is to investigate     the hypothesis: That 10 weeks of Nintendo Wii Fit balance training in a group of seniors (+65     years of age) have a significant effect on postural balance and muscle strength.   "
146155|NCT01371240|"     Accurate preoperative tumor detection and staging are fundamental for treating patients with     pancreatic adenocarcinoma. Patients with unresectable tumors can benefit from being spared an     extensive operation associated with substantial morbidity and mortality, cost, and pain. On     the other hand, patients with localized disease, which is amenable to surgical removal, have     the option of operation. Therefore, accurate staging of pancreatic cancer requires the     detection of the tumor, and evaluation of its size, its relationship to major peri-pancreatic     vascular structures and portal venous system, locoregional lymph nodes, and distant     metastases. Multiple imaging techniques have been used to evaluate the pancreas. Although, at     this point, no consensus exists as to the best staging algorithm, multidetector (MD) computed     tomogrophy (CT) and Magnetic resonance imaging (MRI) provide sufficient information for the     management of most patients.      Patients with a tumor larger than 3 cm are characterized as non-surgical. CT sensitivity in     detecting small pancreatic tumors of less than 2 cm is low. Multiple methods have been     suggested to increase the sensitivity of CT. The sensitivity of CT increases with using     multidetector CT which now has an accuracy rate of about 95-97% for initial detection and     approximating that of 100% for staging.      Secretin (a natural hormone produced by the duodenal mucosal cells) is known to increase     blood flow to the pancreas. The principal use of secretin in imaging today is in exocrine     function of the pancreas or morphological evaluation of the pancreatic duct under ultrasound     or MRI. Theoretically, pancreatic contrast enhancement should also increase after secretin     administration. This would imply that tumor conspicuity might also be increased if contrast     enhancement of the normal pancreas increases. Secretin CT has been advocated by other centers     to improve depiction of the ampulla and periampullary/duodenal diseases and to improve     contrast enhancement. O'Connell et al, used secretin in patients suspected or with known     pancreatic mass and concluded that administration of intravenous secretin leads to greater     enhancement of the pancreas with greater tumor conspicuity, than imaging without secretin.      MRI of the pancreas has undergone a major change because it can provide noninvasive images of     the pancreatic ducts and the parenchyma. MR cholangiopancreatography (MRCP) enables detection     of anatomic variants such as pancreas divisum. Although contrast material-enhanced CT is     still considered the gold standard in acute pancreatitis and for the detection of     calcifications in chronic pancreatitis, MR imaging and secretin-enhanced MRCP are useful in     evaluating pseudocysts and pancreatic disruption.      The role of MR is still debated in pancreatic neoplasms except the cystic lesions where MR     imaging provides critical information regarding the lesion's content and a possible     communication with the pancreatic ducts. Although some articles have shown that MRI was     equivalent to CT in diagnosis and staging, others have shown the opposite. Nishiharu et al.     found comparable tumor detection but a benefit with CT, notably for peripancreatic and     vascular invasion. Comparing CT, echoendoscopy, and MRI, Soriano et al. demonstrated that CT     showed the highest level of precision in primary tumor staging, local-regional staging,     vascular invasion, distant metastases, Tumor, node, metastasis (TNM) staging, and tumor     resectability. MRI retains its originality in imaging the parenchyma, the pancreatic and     biliary ducts, and vascular structures; however, in many institutions, CT remains the     reference imaging choice for diagnosing and staging pancreatic cancer. Other than CT's     advantages for the tumor, its excellent spatial resolution also provides detailed     reconstructions in all planes and arterial mapping and therefore makes it possible to search     for surgical contraindications such as celiac trunk stenosis. MRI is still used today as a     second-intention tool when there is doubt or when CT and echoendoscopy are not sufficiently     conclusive; it is not currently recommended to use MRI in first-intention diagnosis of     pancreatic cancer.      The aim of this pilot study is to determine whether the administration of intravenous     secretin before contrast-enhanced CT and MRI improves pancreatic enhancement and pancreatic     tumor conspicuity and to evaluate which technique is more appropriate for pancreatic tumor     detection, staging and evaluation of resectability.   "
146156|NCT01371227|"     The purpose of this study is to evaluate tolerability of the combination therapy of JNS002     and bortezomib in Japanese bortezomib-naive patients with multiple myeloma who have ever     received at least 1 line of chemotherapy.   "
146157|NCT01371214|"     The primary goal of this study is to perform a 36-week pilot study with a cross-over design     to study the safety and efficacy of a novel integrative exercise program called PLIÉ     (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and     Western exercise traditions and is specifically designed to target the muscles and movements     needed to help individuals with mild-to-moderate dementia maintain physical function and     independence.   "
146158|NCT01371201|"     The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter     study which aims to determine the efficacy of Sunitinib on the progression-free survival at     12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated     with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).   "
146159|NCT01371188|"     Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and     prevalent professional activity of agribusiness segment of the Brazilian economy, exposes     workers and people of neighboring towns to high concentrations of pollutants and, therefore,     potentially several risks to health hazards.      Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers     and volunteers from a nearby town in non-harvest and harvest periods.   "
146160|NCT01371175|"     The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and     recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.      Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled     at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of     up to 10% (approximately 10 additional volunteers) will be permitted in the study.   "
146161|NCT01371162|"     This 2-part, randomized, double-blind, placebo-controlled study will assess the safety,     pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with     hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending     doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).   "
146162|NCT01371149|"     To evaluate a novel advanced physiological monitoring system to improve nocturnal     non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD),     Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS)     patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn,     will improve ventilatory failure, quality of life and reduce length of admission during     initiation of therapy. We aim to incorporate this technology into routine clinical practice.   "
146173|NCT01371006|"     Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when     administered together.      To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe     , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.   "
146163|NCT01371136|"     Although a significant amount of work has been done to validate simulators as viable systems     to teach technical skills outside the operating room, the next necessary step is to integrate     simulator training into a comprehensive curriculum. The purpose of this study is to develop     and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery. This     curriculum will include training on a virtual reality simulator, cognitive training and     cadaver lab training. The investigators will assess the effectiveness of the curriculum by     conducting a randomized single blinded controlled trial. The investigators will be comparing     the technical performance of curricular trained and non-trained residents in the operating     room, during a procedure on a patient. The investigators hypothesize that surgical residents     who participate in the curriculum will have superior technical proficiency and cognitive     knowledge relating to performing laparoscopic colorectal surgery compared to conventionally     trained residents.   "
146164|NCT01371123|"     The purpose of this study is to determine whether children on long-term parenteral nutrition     (>6 weeks) have serum aluminum concentrations that are higher than children (aged and gender     matched) that have never received parenteral nutrition.   "
146226|NCT01370304|"     The purpose of this study is to treat participants with a diagnosis of depressive disorder to     assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in     the treatment of depressive disorders compared venlafaxine only (the optimal medication) and     to rTMS only. fMRI will be performed to determine if treatment response is related to changes     in fMRI, and use it to investigate the respondence to the treatments.   "
146165|NCT01371110|"     Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading     cause of worldwide disability that presents a significant public health problem. Treatment     options are limited and many OCD patients fail to respond completely or quickly to standard     treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to     respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral     therapy, have few additional treatment options aside from deep brain stimulation. Therefore,     despite advances in current pharmacological and behavioral treatments, and the utility of     serotonergic drugs, it is likely that other neurotransmitter systems are involved and that     targeting these systems may increase treatment efficacy. Despite little evidence for     serotonergic dysfunction in OCD, there is significant evidence that glutamatergic     dysregulation may contribute to the development and progression of the disorder. Also,     preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine),     particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The     NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single     intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is     to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant     OCD.   "
146166|NCT01371097|"     The aim of the study is to evaluate the effect of progressive resistance strength training     (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional     training would improve the rehabilitation and increase the level of activity of daily living.   "
146167|NCT01371084|"     The primary aim of this pilot study is to test the efficacy of a worksite intervention for     reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g.,     measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary,     overweight, full-time working adults as compared to a waitlist control. A secondary aim will     be to test pedal time at work as a measure of compliance with the intervention.   "
146168|NCT01371071|"     A majority of patients with multiple sclerosis initially presents with a single demyelinating     event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically     isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple     sclerosis but in those patients who do, irreversible damage of the central nervous system,     e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of     immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at     high risk for the development of multiple sclerosis. Vice versa identification of low risk     patients could help to avoid an unnecessary therapy. In this prospective observational study     we want to follow up patients with CIS and early multiple sclerosis over a period of four     years and obtain clinical, laboratory and MRI - data in order to identify risk factors for     relapses, prognostic factors and therapy response markers.   "
146169|NCT01371058|"     Thrombotic event is one of the most serious complications of coronary artery disease, which     often result in myocardial infarction and even death. Even according to the standard     guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic     events, in high-risk patients, the proportion is higher, this phenomenon is called     anti-platelet drug resistance in clinical practice      The aim of this multicenter prospective, randomized, controlled study is to observed     policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after     Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and     short-term prognosis to find new ways to the prevention of platelet aggregation .   "
146170|NCT01371045|"     The purpose of this study is to test the effect of long-acting somatostatin analog     medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in     comparison to healthy controls who are not receiving the medication in order to see whether     or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance     Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH responses     in non-acromegaly subjects taking somatostatin analog treatment, the relative contribution of     the medication and the underlying disease state can be analyzed.   "
146171|NCT01371032|"     The purpose of this study is to compare:      the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy     during tracheal intubation to the VideoMiller device (the standard pediatric blade with a     camera attached, giving indirect view of the vocal cords in the screen). This intubation     device is used to place the tube in the trachea to keep the patient breathing during the     surgery procedure.      The anesthesiologist obtains a better view of the vocal cords looking at the screen provided     by the VideoMiller.   "
146172|NCT01371019|"     The purpose of this study is to to collect and store blood samples that will be utilized to     develop a multimarker test to predict preterm delivery.   "
146175|NCT01370980|"     The purpose of this study is to implement a support interdisciplinary program(oncologists,     pharmacists, physicians, nurses, leagues against cancer) of medication adherence to oral     oncology treatments. The aim is to ensure continuity of care between     professionals,effectiveness of treatment and patient safety.   "
146176|NCT01370967|"     The purpose of this study is to assess stool consistency, in combination with additional     health-related parameters including gastrointestinal tolerance and health-related quality of     life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and     reasons for changes in the choice of formula or method of feeding among infants in this     sample, as well as incidence of common infant illness and associated healthcare usage.     Anthropometric measures and the frequency and duration of physician- and parent-reported     gastrointestinal and other adverse events will be evaluated.   "
146227|NCT01370291|"     The aim of the study is to evaluate the effects of repetitive transcranial magnetic     stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings   "
146228|NCT01370278|"     The goal of this clinical research study is to compare the effects of sodium bicarbonate to     normal saline when used for clearing mucus blockage in patients with airway stents.   "
146177|NCT01370954|"     This study will be an observational study in which patients who have been prescribed     CerefolinNAC® are invited to participate in surveys regarding their experiences with     CerefolinNAC®. CerefolinNAC® is a medical food indicated for the distinct nutritional     requirements of individuals under treatment for early memory loss with particular emphasis     for those individuals diagnosed with or at risk for neurovascular oxidative stress and/or     hyperhomocysteinemia; mild to moderate cognitive impairment with or without vitamin B12     deficiency, vascular dementia or Alzheimer's disease. The purpose of this study is to     increase the understanding of the role of CerefolinNAC® in managing proper neuronal function     in the brain, provide patients with personalized education and support, and contribute to the     overall understanding of the needs and concerns of patients being treated for early memory     loss.   "
146178|NCT01370941|"     An adequate calcium intake is important for bone turnover and the risk of developing     osteoporosis. Yet many studies have documented that supplementation with calcium tablets are     often associated with a poor compliance, therefore it is important to explore ways to better     calcium influx.      Calcium consumed through dairy products must first be cleaved from the molecules which it is     bound to before it can be absorbed. Chymosin is an enzyme which cleaves the protein binding     between some amino acids in κ-casein. The reaction occurs after ingestion of milk and causes     a process whereby the time the milk is staying gastrointestinal tract is extended, this can     lead to enhanced uptake of calcium.      When the body's calcium balance is in equilibrium excretion in urine (24 h) in roughly the     size of the intake, whereby a measurement of circadian urine excretion of calcium can     determine the amount of calcium absorbed from the intestine.      The investigators want to clarify whether the addition of chymosin to milk increases calcium     absorption. Secondary to explore issues of significance for this effect, including vitamin D     status and amount of daily calcium intake and whether a change in calcium absorption has     immediate effects on bone turnover (measured as plasma osteocalcin, bone specific alkaline     phosphatase (BSAP), and the renal excretion of cross-linked N-terminal telopeptide of type 1     collagen (NTx/Cr) ratio) and on the parathyroid function (measured as PTH). Finally we will     explore relations between bone mineral density (BMD) and the measured parameters (in terms of     P-PTH, P-25OHD, P-1,25(OH)2D, P-osteocalcin, P-BSAP, and U-NTx/Cr).   "
146179|NCT01370928|"     The purpose of this study is to compare the performance of a new prototype colonoscope with a     standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a     smaller diameter than the standard colonoscope. The hypothesis to be tested is that the     prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the     patient. Both colonoscopes are manufactured by the same company.   "
146180|NCT01370915|"     Pregabalin is used for the treatment of neuropathic pain and has shown analgesic efficacy in     postoperative pain. The aim of this randomized, double-blinded, placebo-controlled trial was     to investigate the efficacy and safety of pregabalin for reducing postoperative pain in     patients after septoplasty. Persons who scheduled for elective septoplasty under general     anesthesia were randomly assigned to groups that received either pregabalin (150 mg twice) or     placebo, one hour before surgery and 12 hours after the initial dose. Assessments of pain     (verbal numerical rating scale) and side effects were performed at one, six, 12, and 24 hours     postoperatively.   "
146181|NCT01370902|"     This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the     safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug)     and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated     doses of NNC141-0100 in subjects with Rheumatoid Arthritis.   "
146182|NCT01370889|"     This pilot phase I trial studies resveratrol in postmenopausal women with high body mass     index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of     resveratrol may keep cancer from forming. Studying samples of blood and urine in the     laboratory from postmenopausal women who are taking resveratrol may help doctors learn more     about the effects of resveratrol on biomarkers.   "
146183|NCT01370876|"     To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with     recurrent or metastatic head and neck cancer and to assess the safety profile of these     treatment regimen.   "
146184|NCT01370863|"     The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters     of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal     Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump     inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability     will be evaluated.   "
146185|NCT01370850|"     To perform a clinical validation study of RTVue features in volunteers with various ocular     pathology or no ocular pathology.   "
146272|NCT01369706|"     Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are     restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest     EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part     of security screening processes in e.g. airport controls.      The objective was to determine the safety of screening procedures for ferrous materials with     regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.   "
146186|NCT01370837|"     Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in     arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's     disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly     develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot     fractures. After these fractures have healed, the shape of the foot can be dramatically     altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves     are important in regulating the inflammatory response. This study aims to investigate whether     the inflammatory response is different in patients with polyneuropathy with and without a     history of Charcot's disease.   "
146199|NCT01370655|"     This study is being done to evaluate the antihypertensive efficacy and tolerability of     MK-7145 in participants with mild-to-moderate hypertension.      The primary hypotheses for the study were as follows:        1. Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood          pressure (SBP) in male participants with mild to moderate hypertension that is superior          to placebo, as measured by time weighted average change from baseline over 24 hours          postdose (TWA0-24hrs) on dosing Day 28        2. Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male          participants with mild to moderate hypertension that is similar to hydrochlorothiazide          (HCTZ), as measured by TWA0-24hrs on dosing Day 28        3. The effect of MK-7145 and HCTZ on natriuresis (UNaV) as well as SBP and diastolic blood          pressure (DBP), both as measured by TWA0-24hrs, will be estimated        4. Multiple dose administration of MK-7145 for 4 weeks will be generally safe and          well-tolerated.   "
146187|NCT01370824|"     Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most     frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its     incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the     suspected lesion, in order to determine the subtype of BCC. There are three different     histological subtypes of BCC, from least to most aggressive: superficial, nodular and     aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin     is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes     according to the Dutch guidelines. Recent developments of non-invasive therapies for     superficial BCC might be the first choice of treatment in the future. These non-invasive     treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better     cosmetic results than SE and are therefore also used in the Maastricht University Medical     Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes grow     deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin     respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic     surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the     subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment. A     potential better or equal way to determine the BCC subtype might be the clinical diagnosis.     To our knowledge, there is no literature about the diagnostic value of the clinical diagnosis     to determine the subtype of BCC seen in the SE/MMS specimen. We want to confirm the     hypothesis that the clinical diagnosis is as good as, or even better than the histological     diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this case, patients     don't have to undergo an extra procedure, diagnostic route is shortened.      - Primary objective: to establish the observed agreement of clinical diagnosis compared to     histological diagnosis by to determine the most aggressive subtype of BCC      - Secondary objectives: inter-observer and intra-observer variability of dermatologists and     pathologists to determine subtype BCC.   "
146188|NCT01370811|"     The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution     is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with     excessive salivation.   "
146189|NCT01370798|"     Hypospadias is a congenital abnormality of the penis that is caused by incomplete development     of the anterior urethra. This pathology is one of the most common genital anomalies in     paediatric urology .The incidence is reported to be 1 out of 250 live male births and is     increasing regularly. The hypospadias surgeries present a high risk of post operative     complications requiring re-interventions.      A great part of the post operative complications is related to imperfect healing issues. If     androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact     positively on the skin healing process. This point leads to the hypothesis that local     transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the     number of skin healing post-operative defects.      The objective of the study is to assess the effect of oestrogen (applied once daily for 2     months prior to surgery) on the post-operative complications.   "
146190|NCT01370772|"     Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase monotherapy     before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in previously untreated     symptomatic B-cell chronic lymphocytic leukemia CLL.      A Study from the Goelams GCFLLCMW intergroup   "
146191|NCT01370759|"     The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.   "
146192|NCT01370746|"     In this study, doctors will observe how and when pediatric patients who have received a solid     organ transplant take their prescribed medication, and determining if there are reasons that     keep these patients from taking all of their medicine.   "
146193|NCT01370733|"     This study is designed to evaluate the safety and efficacy of synchronized transcranial     magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects     with Major Depressive Disorder. This is a multicenter study in which subjects will be     randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of     double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy     or antidepressant medications during the follow-up phase of the study. Follow-up evaluation     visits will be conducted during those four weeks, with the frequency of the visits determined     by the treatment choice during that timeframe.   "
146194|NCT01370720|"     Despite the pathophysiology of IBS remains largely unsettled, several mechanisms have been     proposed to explain symptom generation. These include psychosocial factors, altered     gastrointestinal motor function and altered perception of visceral stimuli because of chronic     low-grade inflammation and increased nociceptive mediator release by inflammatory cells,     particularly mast cells.      The aim of this pilot study is to provide evidence of:        1. intestinal mast cell (MC) infiltration and activation in IBS patients;        2. down-modulation of MC activation by the oral administration of the association of          palmitoylethanolamide (PEA) and polydatin in IBS patients.   "
146195|NCT01370707|"     The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.   "
146196|NCT01370694|"     This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in     combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single     agent, for participants with B-lymphocyte antigen cluster of differentiation 20     (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study     hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a     single agent.   "
146198|NCT01370668|"     Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of     the population. Recent research point at the relevance and persistence of cognitive     dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment     has been classically associated with schizophrenia and not bipolar disorder. Current findings     suggest that some intervention is needed in order to improve not only affective symptoms but     also cognitive dysfunctions, so that patients could benefit from cognitive remediation     techniques to improve cognitive impairment and the functional outcome. There is no previous     research on the efficacy of cognitive remediation programs on bipolar disorder.   "
146200|NCT01370642|"     The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir     given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus     treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic     hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of     participants achieving sustained virologic response 24 weeks after completion of all study     therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of     participants achieving SVR24 in the control arm.   "
147653|NCT01351571|"     This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in     combination with interferon alpha-2a as first-line treatment in patients with advanced and/or     metastatic renal cell carcinoma. Data will be collected from each patient for up to 4 years.   "
146206|NCT01370564|"     This chronic, prospective, non-randomized feasibility study is designed to evaluate the     Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic     Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter     Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers     Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) Extension     Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling     pressures from the Chronicle device to provide timely medication adjustments (diuretics) to     subjects.   "
146207|NCT01370551|"     The purpose of this study is to assess the longterm safety and efficacy of the vaginal     application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on     atrophic vaginitis in postmenopausal breast cancer patients who have been treated with     aromatase inhibitors.   "
146208|NCT01370538|"     This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of     frequent heartburn   "
146209|NCT01370525|"     This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of     frequent heartburn   "
146210|NCT01370512|"     The hypothesis is that pyridostigmine will improve the safety factor of ganglionic neural     transmission, while Droxidopa will replete the postganglionic neuron of norepinephrine (NE).     This combination should result in enhanced orthostatic release of NE. The investigators have     already demonstrated that pyridostigmine does not raise supine blood pressure.   "
146211|NCT01370499|"     The primary objective of this study is to evaluate the long-term safety and tolerability of     LY2216684 administered once daily in the adjunctive treatment with an Selective Serotonin     Reuptake Inhibitors (SSRI) for up to approximately 1 year in patients with Major Depressive     Disorder (MDD) who were partial responders to their SSRI treatment.   "
146212|NCT01370486|"     Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome,     various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences.     The tonic seizure occur mostly at night.      The hypothesis is that the melatonin could have a positive effect in that syndrome, by     reducing the epileptic activity (assessed in the polysomnographic record by counting the     number of interictal and ictal discharges) and stabilizing the structure of sleep.      The study is double blind, randomised, cross-over designed.   "
146213|NCT01370473|"     The purpose of this study is to create an institutional and population-based registry of     Hyponatremia with a prospective survey based on epidemiological data, risk factors,     diagnosis, prognosis, treatment, monitoring and survival.      This study will also describe the occurrence of hyponatremia in the population of HIBA in the     Central Hospital, as well as the characteristics of clinical presentation, evolution and     predisposing factors of hyponatremia.   "
146214|NCT01370460|"     This study aims to assess postoperative blood loss and transfusion rates in total knee     replacement after one-time administration of topical tranexamic acid.   "
146215|NCT01370447|"     This study evaluates the safety and efficacy of EPI-743 in patients with severe mitochondrial     respiratory chain diseases who are considered to be within 90 days of end-of-life care.   "
146216|NCT01370434|"     Based the proven efficacy and the ability to induce rapid response of various combinations of     bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple     Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination     (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of     harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.   "
146217|NCT01370421|"     This is an observational study (not a treatment study) of pain and physical functioning after     total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery.     You may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery,     do not have a serious heart condition or certain other medical conditions, and are not taking     certain types of medications. The study includes evaluation of peoples' pain, physical     functioning, medication use, and physiological responses to sensory stimuli such as heat and     cold.   "
146218|NCT01370408|"     In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30     minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy.     On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be     administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen     is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be     administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given     orally for 2 days following chemotherapy.   "
146284|NCT01369550|"     The purpose of this clinical trial is to evaluate whether the omega-3 fatty acid stearidonic     acid (SDA), when used as a food ingredient, increases the level of the long-chain omega-3     fatty acid eicosapentaenoic acid (EPA) in red blood cell (RBC) membranes in men and women.   "
146219|NCT01370395|"     Elderly patients are often admitted to hospital because of chest pain that is atypical for     angina pectoris. In case of inconclusive electrocardiograms, determination of troponin is     important for the diagnosis of an acute coronary syndrome. A highly sensitive assay for     troponin T has recently been developed, permitting measurements of concentrations that are     lower by a factor 10 than those measureable with conventional assays. In patients with stable     coronary artery disease these concentrations were significantly associated with the incidence     of cardiovascular death and heart failure but not with myocardial infarction. Copeptin, a     novel biomarker of endogenous stress, may improve the diagnostic performance of troponin for     an acute coronary syndrome in elderly patients. Other biomarkers such as     MR-pro-adrenomedullin and endothelin-1 could improve both the diagnostic and prognostic     assessment of the physician in these patients.   "
146220|NCT01370382|"     The planned cohort study shall clarify whether the use of biomarkers leads to improved     diagnostic assessment of elderly patients. The study will evaluate the clinical value of     biomarkers (highly sensitive Troponin T, Troponin T of the 4th generation) in elderly     patients. These biomarkers are analyzed together with the symptoms and other parameters     collected at admission. The diagnosis of myocardial infarction could be made earlier and more     accurately with the help of biomarkers, in particular the highly sensitive troponin T.   "
146221|NCT01370369|"     This is an open-label study of a single and repeated application of three dose levels of     topical testosterone in hypogonadal males with morning serum testosterone concentrations <     297 ng/dL.   "
146222|NCT01370356|"     This study will determine whether varenicline is safe and helps people to quit smoking     through reduction when they are not willing/able to make an abrupt quit attempt.   "
146229|NCT01370265|"     Blockage of the heart arteries (coronary artery disease) can lead to angina (chest pain),     heart attacks, heart failure, and/or death. Positron emission tomography (PET) stress     myocardial perfusion imaging (MPI) is a powerful tool to help identify blockages in the     coronary arteries. During the PET MPI test, a drug is given to mimic the effects of exercise     on the heart. The study was done to measure blood flow to the heart using two similar drugs     approved to mimic the effects of exercise on the heart in people during a heart stress test.     The first drug, called adenosine, has been approved for this use for several decades. The     second drug, called regadenoson, was approved in 2008. The investigators were looking at     whether the increase in blood flow to the heart with the newer drug (regadenoson) was similar     to the increase in blood flow with the older drug (adenosine). This information is important     for the use of these drugs in patients and for interpreting the blood flow values.   "
146230|NCT01370252|"     Post-operative pain will be measured using a pain diary for one week post-surgery. The     purpose is to test the assumption that the arthroscopic technique leads to less     post-operative pain and results in shorter hospital stays when compared to the open     technique. It is believed that the arthroscopic technique will result in minimal pain when     compared to the open technique, allowing this procedure to be performed as day surgery.   "
146231|NCT01370239|"     The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to     be safe in previous studies and has also been indicated as potential intervention in breast     cancer. The study of this new agent in advanced breast cancer may contribute to the     development of new strategies for patients that progressed after hormonal treatment.   "
146232|NCT01370226|"     The aims of the study are to develop and refine tailored motivational brief interventions     that are parallel in structure but have varied delivery modalities (computer vs. therapist)     for patients with at-risk or problematic alcohol use, and to conduct a randomized controlled     trial comparing the efficacy of these BI approaches (CBI, TBI, control) on subsequent alcohol     consumption and alcohol consequences, including alcohol-related injury, mental and     physical-health functioning, and HIV risk behaviors at 3-, 6-, and 12-months post-ED visit.   "
146233|NCT01370213|"     This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative     haploidentical transplantation for the treatment of high-risk acute myeloid diseases.     Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early     stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free     neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28     patients will be enrolled for a total of 43 patients. Patients will be followed for disease     response for 2 years.   "
146234|NCT01370200|"     The investigators want to compare the efficacy of plasma exchange treatment with using two     different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment.      The efficacy of plasma exchange treatment is better with using 15% trisodium citrate as     anticoagulant during the plasma exchange procedure.   "
146235|NCT01370187|"     The aim of the current study is to evaluate the effect of Montelukast in treatment of acute     bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age     in Bandar Abbas Children' hospital.   "
146236|NCT01370174|"     Falls and their consequences are among the major problems in the medical care of older     individuals. The long-term goal of this research is to establish the efficacy of a     scientifically grounded and mechanism-based therapeutic intervention for improving balance     function and preventing falls in older people. When human balance is challenged, protective     stepping is a vital strategy for preventing a fall during activities of daily life. Many     older people at risk for falls have particular difficulties with successfully stepping     sideways as a protective response to loss of balance in the lateral direction. We propose     that age-related declines in lateral balance function through impaired protective stepping     that precipitates falls, result from neuromechanical (NM) limitations in hip     abductor-adductor (AB-AD) muscle strength (torque and power). Moreover, we hypothesize that     these functional and NM impairments are reversible with combined high intensity induced step     training (IST) and muscle strengthening.   "
146237|NCT01370161|"     The purpose of this study is to determine whether early use of transjugular intrahepatic     portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to     prolong the survival in cirrhotic patients with high risk acute variceal bleeding.   "
146238|NCT01370148|"     The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour     continuous infusion of conivaptan in subjects with severe liver impairment compared to     subjects with normal liver function.   "
146239|NCT01370135|"     Proliferative ischemic retinopathies lead to a formation of abnormal vessels on the iris     surface induced by an increased level of vascular endothelial growth factor (VEGF). In     progressive stages fibrovascular membranes occlude the anterior chamber angle which inhibits     aqueous outflow resulting in neovascular glaucoma. The increased intraocular pressure is     often difficult to control and frequently results in loss of vision.      The aim of this study is to analyze the short- and long-term outcome after adjuvant     intraocular Ranibizumab application in patients with neovascular glaucoma and rubeosis and to     analyze the role of ranibizumab within a holistic treatment regime.   "
146240|NCT01370122|"     Pelvic Floor dysfunction affects the quality of life of women. However, the prevalence and     risk factors for pelvic floor disorders (PFD) in survivors of gynecologic malignancies are     not known. The investigators plan to perform an observational study including survivors of     gynecologic malignancies. Questionnaires for diagnosis of pelvic floor disorders will be     mailed to survivors to generate prevalence rates and risk factors for PFD in women with a     history of a gynecologic cancer diagnosis.   "
146241|NCT01370109|"     Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell     carcinoma and have significant off-target effects with cardiac toxicity and resultant     ventricular cardiac dysfunction being a major concern. However, the mechanisms of these     effects in humans remains poorly defined, as are the clinical methods to risk stratify and     identify patients who will ultimately suffer from cardiac dysfunction. The goal of this     multi-center study is to characterize the cardiovascular measures of cardiac function; 2)     comprehensive measures of arterial function and left ventricular afterload; 3) biomarkers     reflective of the pathophysiologic alterations. Through this work, the investigators will     translate our basic understanding of sunitinib cardiotoxicity to humans and identify early     predictors of sunitinib cardiotoxicity.   "
146242|NCT01370096|"     To diagnose pulmonary hypertension, children have a cardiac catheterization to check the     blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure     in their lungs. The right ventricle of the heart has to do more work to pump against this     higher pressure. The investigators do not know the best medicine(s) to help children with     pulmonary hypertension when their right ventricles fail. The purpose of the study is to look     at the effects of two different medicines on the blood pressure in the lungs of a child with     pulmonary hypertension. The investigators hope to then be able to choose the best medicine     for children with pulmonary hypertension and right ventricular failure.      The first medicine is called vasopressin. It is a hormone that your body makes on its own.     The investigators will be giving it through an intravenous infusion. The investigators think     that vasopressin works differently in different parts of your body. The investigators are     looking to see the different effects that vasopressin has in the lungs compared to the rest     of the body.      The second medicine is called prostacyclin and is something that your body also makes by     itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary     hypertension as it decreases pressure in the blood vessels. In the catheterization     laboratory, patients breathe in this medicine to measure specific changes in the blood     pressure in their lungs.   "
146243|NCT01370083|"     People with swallowing impairment experience particular difficulty swallowing thin liquids     safely; the fast flow of liquids makes them difficult to control. The tongue plays a critical     role in containing liquids in the mouth, channeling the direction of their flow towards the     pharynx (throat) and controlling their flow along that channel. The investigators are engaged     in a program of research to better understand tongue function in swallowing, particularly     with respect to controlling the flow of liquids. In this study the investigators will compare     two different tongue-pressure resistance training protocols, to determine whether a protocol     that emphasizes strength-and-accuracy or one that emphasizes pressure timing work better for     improving liquid flow control in swallowing.   "
146244|NCT01370070|"     To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic     nasopharyngeal carcinoma (NPC)   "
146245|NCT01370057|"     The purpose of this study is to compare the risk of curve progression in Adolescent     Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.   "
146246|NCT01370044|"     The aim of this clinical trail is to evaluate the efficacy of a Carbogen inhalation in     patients with febrile seizures compared to a placebo-inhalation.      Further aims are the evaluation of the safety of the Carbogen inhalation via a low-pressure     can with a breathing mask in a home-setting, the manageability of the Carbogen inhalation via     a low pressure can with a breathing mask in a home-setting or on the way (mobility), the     quality of life of the parents and children using the low pressure can with a breathing mask     in a home-setting or on the way (mobility) and the contentment and anxiety of the parents.   "
146247|NCT01370031|"     The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung     deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation     of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™     spacer device without or with charcoal block.   "
146248|NCT01370018|"     For more than 20 years, alpha-1-Proteinase Inhibitor therapy (Zemaira®) has been the standard     treatment for patients who have too little alpha-1-Proteinase Inhibitor in blood. Adult     patients with this condition eventually develop emphysema. Most HIV-1 patients who have low     viral load also have too little alpha-1-Proteinase Inhibitor in blood. Recent strong evidence     shows that the number of CD4 cells in blood goes up when alpha-1-Proteinase Inhibitor goes     up. Patients were asked to participate in a pilot study to see whether the use of Zemaira®     (alpha-1-Proteinase Inhibitor) would increase blood levels of alpha-1-Proteinase Inhibitor     and consequently increase CD4 cells.   "
146249|NCT01370005|"     This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2     diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and     macrovascular complications, assessment of both glucose and blood pressure lowering effects     of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly     relevant, new information for the use of BI 10773   "
146320|NCT01369082|"     The purpose of this study is to provide patients who have received at least one islet     transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT)     clinical trial with maintenance immunosuppressive medications and to collect information     about the safety of the medications and islet function.   "
146250|NCT01369992|"     Cancers are among the most frequent leading causes of death in Taiwan, and many of them show     their respective unique epidemiological and pathophysiological features in Taiwanese     population. One of the distinguishing features of cancers includes their potential to     metastasize outside the primary tumor. Pleural cavity and peritoneum are two of the most     frequent sites of metastases when serosal surfaces are involved. The prognoses of such     patients are extremely poor with a median survival of months. The understandings of cancer     biology of tumor metastasis demand more in-depth studies at the molecular and cell levels.     Studies based on cell culture are excellent approaches for this purpose as the cell culture     provides a relevant and renewable model for studying the pathological and molecular changes     underlying human malignant tumors.   "
146251|NCT01369979|"     The investigators wish to determine the lumped constant (LC), which is a correction factor     necessary for converting measurements of hepatic FDG metabolism (measured by PET) to those of     regular glucose in patients with cirrhosis and healthy subjects.      Working hypothesis        -  LC for FDG in liver tissue is not significantly different from unity in healthy subjects        -  LC for FDG in liver disease is significantly different from LC in healthy liver        -  Insulin changes the LC for FDG in liver tissue, but not by the same factor in liver          disease and healthy subjects.   "
146288|NCT01369498|"     This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow     fibrosis either alone or in combination with ruxolitinib in participants with Primary     myelofibrosis (PMF) and Post Polycythemia Vera or Post Essential Thrombocythemia     Myelofibrosis (ET/PV MF).      The study is designed as a two stage trial. In the stage 1, patients will be randomized into     two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, patients on     ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.   "
146289|NCT01369485|"     The purpose of this study is to evaluate the change from baseline between the active and sham     treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).   "
146290|NCT01369472|"     This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg,     64mg, 128mg in healthy male volunteers.   "
146252|NCT01369966|"     Background:      - Smoking is associated with serious health risks. People who have mental illness are more     likely to smoke. Researchers are studying the brain circuits linked with smoking and nicotine     craving. This study will look at whether a specific brain circuit can explain the high rate     of smoking in people with schizophrenia.      Objectives:      - To study brain activity in smokers and nonsmokers with and without schizophrenia, as well     as their family members.      Eligibility:        -  Current smokers (at least 100 cigarettes in the past year) and nonsmokers between 18 and          62 years of age in one of the following groups:        -  Have been diagnosed with schizophrenia.        -  Family members of those with schizophrenia.        -  Healthy adults with no history of severe mental illness or brain trauma.        -  Family members of the healthy adults.      Design:        -  People in the study will be screened with a physical exam, medical history,          questionnaires, and blood tests.        -  They will have up to three visits: the screening visit and two study visits (each given          1 year apart).        -  At the first study visit, those taking part will be trained in the tests they will do          during the magnetic resonance imaging (MRI) scan. Then they will have the MRI scan.        -  After the first study visit, current smokers will receive phone calls from the study          researchers every other month for 1 year. They will be asked about their smoking habits.        -  At the second study visit, current smokers and some nonsmokers will have another MRI          scan and the same tests as before.        -  Current smokers will receive a final phone call 1 year after the second study visit.          They will be asked to give information about their smoking habits.   "
146253|NCT01369953|"     Since 2007, the cost of sequencing a diploid human genome has fallen dramatically, from     approximately $70 million to $20,000. As affordable sequencing platforms become more widely     available, the advancement of biomedical science will draw increasingly on whole genome     sequencing research requiring large cohorts of diverse populations. Key policy, ethical and     legal implications of these developments will need to be understood in order to promote the     efficacy and effectiveness of genomic research going forward.      An overall aim of this project is to obtain feedback on the informed consent process from     some of the earliest particpants in studies using whole genome sequencing. A more specific     goal is to characterize the salient personal and public references accessed by participants     around the time of the informed consent process. By highlighting trends in participants views     about study participation around the time of the initial informed consent process, we aim to     advance the development of an ethically and socially relevant vocabulary with which to     negotiate future terms of use for personal sequence data in genomic research.      Participants will be asked to complete a one-time, semi-structured telephone interview     lasting approximately 45 minutes in the period 2-8 weeks following their initial informed     consent session at the NIH. They will be recruited from two NIH protocols employing whole     genome sequencing for distinct purposes. They The ClinSeqTM Study is a large-scale medical     sequencing project investigating the causal role of genetics in cardiovascular disease     enrolling both symptomatic and healthy individuals. The Whole Genome Medical Sequencing for     Gene Discovery Study (WGMS) enrolls children and adults for full sequencing with the aim of     discovering the genetic etiology of rare conditions.   "
146270|NCT01369732|"     During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and     reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the     lower extremities and successive reperfusion results in injury to remote organs, including     kidneys. So, there has been considerable interest in the development of therapeutic     strategies aimed at attenuating IR injury. One such group of agents that are attracting     interest due to their potential protective effects on vascular endothelium is the     erythropoietin.      However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not     been fully clarified. Therefore, the purpose of this study is to determine whether the     prophylactic administration of erythropoietin reduce the incidence of acute kidney injury     (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The     investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min     before the commencement of ischemia. The differences between the control and study groups are     observed by clinical indicators such as serum creatinine, TNF-α, NGAL.   "
146254|NCT01369940|"     Background:      -Normal growth and development of twins are important for a healthy pregnancy and the     long-term health of the children. This study will look at how twins grow and develop inside     the womb. This knowledge may reduce and/or prevent pregnancy and newborn health problems in     the future.      Objective:      -To describe how twins grow.      To describe how identical (from the same egg) and fraternal (from different eggs) twins grow.        -  To compare growth patterns between twin and single pregnancies.        -  To find out how many babies have growth problems and why they have them.      Eligibility:      -Women from nine U.S. clinical centers who are in the first three months of a twin pregnancy.      Design:        -  Participants will answer questions about personal characteristics (age, education,          race). They will also answer questions about pregnancy history, health behavior, and          their environment. This will take about 30 minutes. They will also fill out a          questionnaire about physical activity, and mood and depression. An ultrasound will be          done to check on the babies measurements.        -  Participants will return for six visits during their pregnancy. Each follow-up will          include an ultrasound and a test to measure the length of the cervix. We will ask          questions about health and any events or symptoms since the visit before. We will also          take body measurements.        -  A nutrition questionnaire will be completed at the first visit and at follow-up visits 2          and 5.        -  Blood will be drawn at the beginning of the study, at three follow-up visits, and just          before delivery.        -  When the babies are born, they will have placenta and cord blood samples, measurements,          and swabs from the inside of the mouth.   "
146255|NCT01369927|"     The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a     saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide     component consists of an average of 3.5 repeat units of the O-SP plus the core region of the     LPS (O-SPC). The O-SPC is covalently bound to the recombinant non-toxic exoprotein B of     Clostridium difficile.      The objective of this phase of the study is to determine if this vaccine is safe and can     induce IgG antibody type-specific immunity to shigellosis in adults. The overall objective is     to determine if this vaccine can elicit higher levels of IgG antibody than the previous     experimental vaccines made with the full length O-SP, shown to be >70% efficacious in greater     than or equal to3 year old children, to induce type-specific immunity to shigellosis in     younger children.      Sixty 18-49 years-old healthy adults will be recruited in Israel. Volunteers will be     vaccinated on a random basis with one i.m. injection of 10 or 25 micrograms of the     investigational conjugate vaccine. Local and systemic reactions will be observed at 30     minutes, and the volunteers will be instructed to take their temperature and examine the     injection site for redness and swelling and fill out a questionnaire at 6, hours and daily     for 7 days after vaccination. The volunteers will visit the clinic at 24 or 48 hours     following the injection and any time they request it. The study will commence with 5     volunteers injected with the 10ug dose to be followed, if no severe adverse reactions occur,     by 5 volunteers injected with the 25ug dose. If a severe adverse reaction occurs on 1 of the     5 volunteers in either group, 5 more will be injected with that dose. If there are no severe     adverse reactions the study will proceed. If there is one more severe reaction the study will     be halted and re-evaluated by the IRB and the FDA.      Vaccine-induced antibodies will be measured at 1 and 6 months after immunization, and     compared to those elicited by our previous S. sonnei conjugate vaccines.      There is a body of evidence that a critical level of serum IgG antibody to the O-specific     polysaccharide domain of LPS confers type-specific immunity to S. sonnei as well as to other     Shigella:        1. Shigellosis is rarely observed in infants up to the age of 4-6 months. The most obvious          explanation for this is that maternally-derived serum IgG provides this immunity;        2. There is an age-related development of IgG anti-LPS antibodies that, in many instances,          is not induced by the homologous bacteria but by non-pathogenic cross-reacting enteric          bacteria;        3. The highest incidence, morbidity, and mortality occur during 6 months to 6 years of age          when the maternally-derived serum anti-O-SP has waned and the naturally-derived          antibodies have not yet appeared;        4. One injection of a S. sonnei-rEPA conjugate showed significant protection against          shigellosis in Israeli Defense Force soldiers. Vaccinees who developed shigellosis          showed significantly lower serum IgG responses to the homologous LPS than those did          not.The high antibody level induced by the conjugate vaccine indicates the positive          correlation between the serum IgG anti-LPS levels and immunity to S. sonnei infection;        5. Following Phase 1 and Phase 2 studies that showed safety and age-related immunogenicity,          a double-blinded randomized and vaccine-controlled Phase 3 evaluation of S. sonnei and          S. flexneri type 2a O-specific polysaccharide (O-SP) protein conjugates was conducted          among 1-4 year-olds in Israel.      For recipients of the S. sonnei conjugate 71.1% efficacy was shown among 3-4 year-old     recipients, no efficacy was shown for recipients of S. flexneri 2a. There was no     statistically significant efficacy for either vaccine in the 1-3 year-olds. Levels of serum     IgG anti-O-SP were elevated according to the vaccine the children received but G.M. levels     declined rapidly several months after the last injection. Our interpretation is that the     age-related efficacy of the Shigella conjugates was due to the conjugate-induced O-SP     antibody levels. Accordingly, we have developed a method to increase the immunogenicity of     the conjugates to approach the antibody levels of Israeli soldiers shown to be protected by     our S. sonnei O-SP.      Low-molecular-mass O-SP-core (O-SPC) fragments were isolated from S. sonnei LPS, and bound by     their reducing ends to the carrier protein. The O-SPC conjugates used oxime linkages between     the terminal Kdo residues at the reducing ends of the S. sonnei saccharides and aminooxy     linkers bound to the carrier. The coupling reaction was carried out at a neutral pH and room     temperature. The carrier protein was a mutant non-toxic Clostridium difficile exotoxin B. IgG     antibody levels induced in young outbred mice by this new S. sonnei O-SPC conjugate were     significantly higher than those elicited by the O-SP conjugates.   "
146256|NCT01369914|"     Background:        -  Stem cell transplantation (SCT) is used to treat some kinds of cancer, blood cell          disorders, and immune disorders. Stem cells from a donor s blood are used to replace the          recipient s stem cells in the bone marrow. The recipient s bone marrow can then produce          new blood cells. Some of these new cells involved in the immune system are like the          donor s cells. Sometimes immune cells from the SCT attack the recipient s normal          tissues, including the eyes. This type of immune attack is called graft-versus-host          disease, or GVHD.        -  The symptoms of ocular GVHD include eye pain, irritation, dryness, and inflammation.          When it is severe and if it does not respond well to treatment, ocular GVHD may also          cause vision loss.      Objective:      - To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had     stem cell transplantation.      Eligibility:        -  Participants must be at least 18 years of age.        -  They must be taking part in a study at the National Cancer Institute (NCI) or the          National Heart, Lung and Blood Institute (NHLBI).        -  They must have a SCT scheduled within the next 30 days.      Design:        -  The study lasts for 1 year and includes six visits to the National Eye Institute. (There          is an optional visit about 1 month before your SCT.) When possible, visits for this          study will be scheduled so that they can be done on the same day as your visits for the          NCI or NHLBI protocol that you are taking part in.        -  At each visit, participants will have a medical exam and an eye history will be taken.          They will have an eye exam and a test to measure the ability to make tears. Those in the          study will also have tear fluid collected for analysis in a lab. Tear fluid collection          is a painless process. Blood will be drawn during certain visits if it has not already          been collected by the transplant team.   "
146291|NCT01369459|"     The goal of this project is to develop and test a brief protocol designed to systematically     integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD)     into behavioral treatment services for adolescent substance users with co-morbid ADHD in     everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and     fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services     utilization, medication acceptance and compliance, and satisfaction with treatment services.   "
146257|NCT01369901|"     Background:      -Spinal and bulbar muscular atrophy (SBMA) is an inherited disorder that affects men. People     with SBMA often have weakness throughout the body, including the muscles they use for     swallowing, breathing, and speaking. We do not know if exercise helps or harms people with     SBMA.      Objective:      -To see if a 12-week program of either functional exercise or stretching exercises will     improve strength, function, or quality of life in people with SBMA      Eligibility:        -  Participants will be men 18 years of age or older who have genetic confirmation of SBMA.        -  They must be able to walk at least 50 feet with or without an assistive device such as a          cane or a walker and stand for 10 minutes without using an assistive device.        -  They must have access to a computer with an Internet connection.      Design:        -  At the first visit to NIH (2 days), participants will have a medical history taken and          undergo a physical exam. They will also have blood tests and an EKG, and complete          questionnaires about mood, health, and exercise. Tests of muscle strength, balance, and          endurance will also be done.        -  Participants who qualify for the study will receive instruction about either          strengthening or stretching exercises. They will do these exercises at home one to three          times a week for 12 weeks.        -  They will wear a small activity monitor while they exercise and record their exercise in          a diary.        -  At the end of 12 weeks, participants will return to the NIH for 2 days. They will          undergo the same tests as they had on the first visit.        -  Participants will receive follow-up phone calls and e-mails during the study and for 4          weeks after the last visit.   "
146258|NCT01369888|"     Background:      - Researchers have developed an experimental cancer treatment called cell therapy. White     blood cells called lymphocytes are taken from a tumor, grown in large numbers in the lab, and     then given back to the patient. Interleukin-15, given to the patient after the cells (now     called Young tumor-infiltrating lymphocytes of Young TIL cells) are replaced, helps the cells     to grow and boosts the immune system. This process changes your normal cells into cells that     are able to recognize your tumor has been studied in the lab. These cells can destroy tumor     cells in the test tube, but scientists want to see if they work inside the body.      Objectives:      -To test the effectiveness of lymphocytes drawn from tumor cells combined with interleukin-15     in treating metastatic melanoma.      Eligibility:        -  Patients must be 18 - 66 years of age and have a diagnosis of metastatic melanoma.        -  They will have heart and lung function tests, lab tests, and imaging procedures.        -  Patients may not have conditions such as active systemic infections, blood clotting          disorders, or other active major medical illnesses.        -  Patients may not be pregnant or nursing.   "
146271|NCT01369719|"     Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral     iron chelators reduce iron overload in transfusion dependent patients. The aim of this study     is to compare the efficacy and safety of osveral and desferal in transfusional iron overload     patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.   "
146346|NCT01368744|"     The study will determine the sensitivity, specificity, negative predictive value and positive     predictive value of the OSNA Breast Cancer System by comparing its performance to an     extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during     standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.   "
146259|NCT01369875|"     Background:      - Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor     tissue. The cells are modified to help them kill tumor cells, then given back to the person     with cancer. By giving these cells to patients, researchers hope to improve the current     treatments available for patients with melanoma that has not responded to standard therapies.     The TIL will be given after treatments that will suppress the immune system. This makes it     easier for the TIL to attack the cancer cells. The TIL will also be given with aldesleukin     (IL-2), which is designed to help keep the TIL cells alive in the body.      Objectives:      - To study the safety and effectiveness of specially modified tumor infiltrating lymphocytes     to treat melanoma that has not responded to other treatments.      Eligibility:      - Individuals at least 18 years of age who have metastatic melanoma that has not responded to     other treatments.      Design:        -  Participants will be screened with a physical exam and medical history. They will also          have blood tests and imaging studies.        -  A piece of tumor will be collected and white blood cells will be separated to make the          TIL for the treatment.        -  Participants will take drugs to suppress the immune system for 7 days before the start          of treatment.        -  Participants will receive the TIL in a single dose. Then they will receive IL-2 every 8          hours for up to 15 doses. Participants will remain in the hospital for up to 2 weeks          after treatment. They will be monitored with frequent blood tests and other studies.        -  After leaving the hospital, participants will have regular followup visits every 1 to 4          months for the first year. Then they will return for followup every 3 to 4 months, as          directed by the study researchers.   "
146260|NCT01369862|"     The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose     of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza     virus infection. It is also performed to assess immunogenicity and pharmacokinetics     (shedding).   "
146261|NCT01369849|"     This phase I/II trial studies the side effects and best dose of v-akt murine thymoma viral     oncogene homolog 1 (Akt) inhibitor MK2206 when given together with bendamustine hydrochloride     and rituximab and to see how well they work in treating patients with refractory chronic     lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth     of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth     of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal     antibodies, such as rituximab, can block cancer growth in different ways. Some block the     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or     carry cancer-killing substances to them. Giving Akt inhibitor MK2206 with bendamustine     hydrochloride and rituximab may be an effective treatment for relapsed chronic lymphocytic     leukemia or small lymphocytic lymphoma.   "
146262|NCT01369836|"     The purpose of this study is the following:        -  To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered          tafamidis in Japanese and Western healthy volunteers at single dose.        -  To compare Japanese and Western PK profiles.        -  Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a          validated ex vivo assay.   "
146263|NCT01369823|"     The purpose of this study is to examine whether pump treatment combined with the use of     continuous glucose monitoring system is a mena to normalize glycaemic control.   "
146264|NCT01369810|"     To investigate how a switch from fixed combination treatment (ICS and LABA) to other     treatments influence asthma or COPD treatment failure   "
146292|NCT01369446|"     The purpose of this study is to demonstrate that the Eeva System may be used to identify     embryos on Day 2 that are most likely to form blastocysts.   "
146265|NCT01369797|"     Background :      The evolving concept of frailty was born in the United States under the term of  frail     elderly . It allows describing geriatrics situations, dominated by the weakness or the     functional instability of aged person, illustrating situations at risk. It is about an     effective concept, especially in the field of the prevention where it determines strategies     of specific care. The ageing, changing according to individuals, is characterized by a     decrease of the physiological reserves leading to a precarious balance and to a     destabilization.      Epidemiological studies show a very uneven distribution of three categories of old persons     according to their health status. Every year, approximately, 12 % of the independent     population of 75 years of age and older and living at home, lose their autonomy for one of     the activities of the daily life and turn into frailty.      Identifying frailty of old subjects is interesting in order to apply preventive and specific     care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA)     is the gold standard to detect frailty in this population. The beneficial effects of the GGA     during the hospitalization have been recognized in international literature.      The ageing heterogeneousness complexity and the high time-consuming character of GGA led to a     difficult approach for the nurses or family practioners in taking care of old persons at     home.      To balance these difficulties and to optimize prevention of dependence in the elderly, an     experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis of     Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital University     of Limoges. It is an innovative organizational structure because, for the first time, the     geriatric expertise is proposed freely to the elderly at home. A multidisciplinary     gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an     occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA     to detect the risks of loss of autonomy and to propose a coordination of preventive actions.      Purpose :      UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This     action is led in partnership with all the professionals working around old persons.      The randomized study endpoint is to evaluate elderly from 75 years of age and older at home     and to select two homogeneous groups: reference and  specific intervention .   "
146266|NCT01369784|"     The purpose of this study is to evaluate the prognostic value of clinical and biological     factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.   "
146267|NCT01369771|"     The objective of this study is to investigate corneal confocal microscopic findings, ocular     signs and symptoms in patients on treatment with the preserved prostaglandin analogue     latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free     prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using     latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion     criteria including the specified ocular symptoms and signs, will switch from latanoprost     0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve     (12) months.   "
146268|NCT01369758|"     The objective of this study is to demonstrate the safety and effectiveness of community     gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the     MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.   "
146269|NCT01369745|"     Thus study will test an experimental drug called Z-102 (combination of prednisolone and     dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.   "
146273|NCT01369693|"     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users     will be given repeated doses of four different types of portion snus: General, Catch,     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.   "
146274|NCT01369680|"     The study is a maximum tolerated dose finding study for oral, chronic, daily administration     of oral ketamine (by mouth) in children with long-term daily pain.   "
146275|NCT01369667|"     The purpose of this study is to determine whether vitamin D supplementation is effective in     the prevention of relapse in Crohn's disease.   "
146293|NCT01369433|"     Open-label, multi-center, multi-national rollover study to allow continued access to     tivozanib for subjects who have participated in other tivozanib (monotherapy or combination)     protocols. Eligible subjects will continue to receive tivozanib at the same dose and schedule     as per the original (parent) protocol. The length of time that a subject must be on the     parent protocol before rolling over to this protocol will be dictated by the (original)     parent protocol. Subjects will be seen by the investigator every 4 weeks (± 5 days). Adverse     events and blood pressure will be recorded. At the beginning of Cycle 1 and at the beginning     of every odd-numbered cycle (Cycle 3, Cycle 5, etc), clinical laboratory values will be     recorded. CT scans to assess disease will be performed at the end of even-numbered cycles     (Cycle 2, Cycle 4, etc).   "
147681|NCT01351207|"     The objective of this randomized, double-blinded, placebo-controlled, 3-way crossover pilot     study is to determine whether eggs can favorably alter biomarkers of postprandial metabolism     when included with other cooked breakfast foods typically selected by older Americans.   "
146276|NCT01369654|"     The investigators propose to conduct formative research to gain an understanding of patients'     needs and desires regarding elective Bilateral Salpingo-Oophorectomy (BSO) decision making,     and to develop and pilot test a BSO Decision Support Guide, in preparation for a randomized,     controlled trial of the effect of this decision aid on decision quality and use of BSO. The     proposed study will consist of 3 phases. In phase 1, the investigators plan to conduct focus     groups among women who have had a hysterectomy with or without bilateral     salpingo-oophorectomy (BSO) to gain an understanding of what they understood about BSO and     its possible outcomes at the time of their hysterectomy and what they would have liked to     have known, the extent and manner in which they were included in decision making regarding     BSO, and how they feel about the decision now. The investigators also will collect     qualitative data from women who are scheduled for hysterectomy and currently facing the     decision whether or not to undergo elective BSO. In phase 2, the investigators plan to create     a BSO Decision Support Guide using information obtained from the literature, from our     formative research, and the experience of providers who have counseled women about this     choice. In phase 3, the investigators plan to pilot test the BSO Decision Support Guide among     women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and     usability for patients and their providers and to prepare for a randomized study of its     impact on decision quality and use of BSO. 62 women who are scheduled to undergo hysterectomy     for a non-cancerous uterine condition will participate in the pilot study. These women will     participate in a baseline interview, during which they will be provided access to the BSO     Decision Support Guide, and 2 follow up telephone interviews (one as they are making their     final BSO decision and a second after they have undergone and recovered from their     hysterectomy (with or without BSO). Data will be used to generate the final version of the     Decision Support Guide, to finalize evaluation measures for future studies of the     effectiveness of the guide, and to determine effect sizes for the outcomes of knowledge, BSO     use, decision satisfaction and decisional conflict.   "
146277|NCT01369641|"     This is a pilot, randomized, self-controlled study of the effects of intratympanic sodium     thiosulfate (STS) on the degree of hearing loss in patients receiving cisplatin therapy.     Sodium thiosulfate is an inactive ingredient contained in sulfacetamide ophthalmic solution     which is used routinely as an otic solution delivered to the middle ear space.      The hypothesis of this study is that local administration of sodium thiosulfate (STS) will     result in improved hearing compared to ears not receiving the study drug in patients     receiving systemic cisplatin therapy.   "
146278|NCT01369628|"     The sponsor electively terminated the study because the risk mitigation measures, deemed     necessary after an unforeseen safety event, could not be effectively implemented within this     protocol while maintaining study timelines within a reasonable time frame.   "
146279|NCT01369615|"     The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride     (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17     years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid     therapy who completed the 4 -week treatment period in OTR3001.   "
146280|NCT01369602|"     The primary purpose of this study is to evaluate the pharmacokinetics, safety and     tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.   "
146281|NCT01369589|"     The primary objective of this clinical study is to determine the impact of P-552 oral rinse     on salivary volume after administration of a single dose of P-552and versus vehicle rinse.     Changes in oral mucosal wetness will be assessed via collection of salivary output and via     measurement of oral wetness using the Periotron 8000 instrument.   "
146282|NCT01369576|"     The clinical population targeted will be newly diagnosed patients with polysomnographically     diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia.     Outpatients who are also judged to be capable to follow the study procedures (consent,     timelines, visits, questionnaires) and who do not have any concurrent disease that in the     view of the investigator will interfere with participation in the trial to completion will be     included. Approximately 160 subjects were recruited (80 per treatment arm) in the recent     trial of eszopiclone. This size is expected to be able to discern an important difference of     80 minutes per night. In the current clinical population newly prescribed CPAP at Mount Sinai     Hospital, the average compliance after 4 weeks of initiation of nCPAP was 4:01 (SD 2:59)     hours per night. To be able to discern a difference of at least 1 hour (60 minutes) in usage     per night, including entirely non-adherent patients who do not use treatment at all as 'zero     hour' users, would require randomization of 264 patients (132 per group).      Our hypothesis for this study is that initial titration of CPAP treatment of OSA may be     improved by initial prescription of a common hypnotic, zopiclone. To answer this question we     intend to recruit 264 consecutive consenting subjects with OSA confirmed by a physician (ABSM     or by a respirologist with extensive sleep medicine experience) with supportive     polysomnography results who are willing to initiate long-term CPAP treatment.   "
146283|NCT01369563|"     To assess the efficacy, safety and tolerability of ciclesonide 200 mcg once daily, applied as     a nasal spray for four weeks. The main outcome will be the improvement on global and     individual typical and associated symptoms of intermittent or persistent rhinitis.   "
146285|NCT01369537|"     Two hundred million adults worldwide have major surgery every year. A million of these     patients will have an obvious stroke after their surgery. Another 10 million patients may     have silent strokes. Although silent strokes are not diagnosed immediately, they are likely     to reduce patients' short-term memory, concentration, and ability to function at home.     However, the investigators do not know how common silent strokes are after noncardiac     surgery, nor the extent to which they affect brain function.      The investigators will first perform a pilot trial to determine the feasibility of the larger     study that will provide the definitive answer to this question. Participating patients will     be assessed by questionnaire before and after surgery, and will have a magnetic resonance     imaging (MRI) study of the brain after the surgery to look for silent strokes. Combining the     results of the MRI and the questionnaires will allow us to determine the frequency of silent     strokes after non-cardiac surgery, and their effect on brain function. The NeuroVISION Pilot     Study will determine the feasibility of a large study to examine the frequency and the impact     of silent stroke in patients who undergo noncardiac surgery.   "
146286|NCT01369524|"     Although the investigators take many measurements to monitor the fluid state of the patients,     it is not known exactly whether the fluid has real effect on the organ perfusion. The main     focus of fluid is to improve the organ perfusion. Recent research has focused on the     investigation of sublingual microcirculatory alterations.   "
146287|NCT01369511|"     The primary objective of this study is to test the hypothesis that appendicular lean body     mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older     participants undergoing elective total hip arthroplasty (eTHA).   "
147706|NCT01350882|"     Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a     composite TREATMENT FAILURE   "
146295|NCT01369407|"     REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory     patients with chronic, advanced, systolic heart failure that will provide a greater     understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD     use and death), and of how baseline clinical risk measures are related to prognosis.   "
146296|NCT01369394|"     The goal of this study is to determine whether a computer-based intervention that delivers     individually-tailored educational messages about the MMR vaccine increases MMR     vaccine-hesitant parents' intentions to have their children vaccinated.   "
146297|NCT01369381|"     Current methods for endotracheal intubation in the presence of cervical spine (c-spine)     instability are not evidence-based. This is so because the relationships between the forces     applied during intubation (by the laryngoscope) and the resulting c-spine movement have not     yet been quantitatively characterized. As a result, with the current level of knowledge, it     is not known, and it is not possible to predict, which types of c-spine instability have the     greatest risk of cervical spinal cord injury with intubation. This shortcoming makes it     impossible to know which intubation devices and techniques are likely to be safest in the     presence of c-spine instability.      To address this critical lack of knowledge, the overarching purpose of the proposed research     is to: 1) quantitatively relate c-spine movement that results from the forces applied to the     peri-airway tissues during intubation (force-motion relationships), and 2) use these data to     develop a mathematical model of the c-spine that will predict which types of c-spine     instability result in the greatest amount of abnormal c-spine motion and associated spinal     cord compression during intubation.      This clinical study will utilize laryngoscope blades that are instrumented with a high     resolution pressure mapping system to make high-resolution measurements of the forces and     pressures of intubation while making simultaneous measurements of c-spine motion. In this     study, study subjects will be intubated using both a conventional (Macintosh) laryngoscope     and an alternative (Airtraq) laryngoscope. By using two different laryngoscopes, we, the     investigators, will introduce forces of differing magnitudes and distributions to peri-airway     tissues. The Airtraq does not require a direct line of sight to visualize the vocal cords,     and among the various new alternative laryngoscopes it is the only one that has been shown to     result in 30-50% less cervical motion than a conventional (Macintosh) laryngoscope.     Accordingly, we hypothesize 1) 30-50% less force will be applied with the Airtraq     laryngoscope than with the conventional (Macintosh) laryngoscope and 2) 30-50% less c-spine     motion will occur with the Airtraq. By studying (intubating) each subject twice, any     differences in the c-spine force-motion relationships between devices will be due to the     devices themselves. By studying each subject twice, we can account for (and eliminate)     differences among study subjects in c-spine biomechanical properties.   "
146298|NCT01369368|"     Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis     is that a combination therapy can stabilize the disease for patients with early relapse after     allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg     daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans     retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle.     Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day     10 is allowed from the second cycle.   "
146299|NCT01369355|"     The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance     regimens of ustekinumab administered subcutaneously to patients with moderately to severely     active Crohn's disease who responded to treatment with intravenous ustekinumab in studies     CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.   "
146300|NCT01369342|"     This study (UNITI-2) will compare the effects (both positive and negative) of an initial     treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely     active Crohn's disease.   "
146301|NCT01369329|"     This study (UNITI-1) will compare the effects (both positive and negative) of an initial     treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely     active Crohn's disease who have either failed or could not tolerate at least one     TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab     pegol).   "
146302|NCT01369316|"     That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at     least as safe but more effective than conventional EMR for injection assisted EMR of large     laterally spreading tumour and sessile polyps of the colon.   "
146303|NCT01369303|"     The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics     (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing     regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex     acts.   "
146304|NCT01369290|"     Current methods of choosing treatment for major depressive disorder (MDD) are inefficient.     The Strategic Treatment to Achieve Remission of Depression (STAR*D) Trial revealed that only     about 1/3 of patients treated with antidepressant drugs will go into remission with the first     medication chosen. We hypothesize that pattern recognition software using Machine Learning     methods can accurately predict response to a variety of antidepressant medications (ADM) or     cognitive behavior therapy (CBT) after training using pre-treatment demographic, clinical,     laboratory or electroencephalographic (EEG) data. These algorithms might assist the clinician     to chose, for any given patient, an antidepressant treatment option with greater probability     of favourable response than is achievable using current best practise methods.   "
146305|NCT01369277|"     This study is to investigate the safety, tolerability and pharmacokinetics of single     ascending oral doses of PF-04991532 in Japanese healthy subjects. The secondary objective is     to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532     in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western     healthy subjects.   "
146306|NCT01369264|"     The proposed study is designed to determine whether small changes in the positioning of a     transcranial magnetic stimulation coil over the frontal parts of the brain cause different     patterns of brain activation measured by electroencephalography (EEG) and quantitative EEG     (QEEG).   "
146307|NCT01369251|"     The purpose of this study is to determinate whether in newborns just cleaning the umbilical     stump when changing diapers (with water and soap if necessary)is effective in preventing     local cord infections and not delaying cord separation as just as cord care alcohol, usually     applied in our hospital and suggested to parents at dismission.   "
146308|NCT01369238|"     1. Purpose of study             1. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom               Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale             2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom               Acupuncture Therapy on Whiplash-Associated Disorders using NDI, BDI, SF-36, and               EQ-5D.        2. Interventions & Groups             1. group 1: Bee-Venom Acupuncture Therapy             2. group 2: zaltoprofen             3. group 3: Bee-Venom Acupuncture Therapy & zaltoprofen   "
146309|NCT01369225|"     This is a study to evaluate the safety and tolerability of multiple doses of AAB-003     (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete     study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each     patient's participation will last approximately 52 weeks.   "
146310|NCT01369212|"     This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks     followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir     alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome     will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained     off-treatment response).   "
146311|NCT01369199|"     The investigators propose to evaluate the safety and efficacy of a short lead-in course (8     weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40     weeks. The investigators hypothesize that using a potent nucleos(t)ide analogue will provide     a higher rate of loss of HBeAg loss and suppression of HBV DNA.   "
146312|NCT01369186|"     Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and     pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel,     ticagrelor)   "
146313|NCT01369173|"     The foods eaten daily are considered the dietary pattern of a culture or country. The     dietary pattern of Mexico is different from that of the United States. To look at the effects     of these patterns, participants in this study eat a Mexican menu for three and a half weeks     and an American menu for the same length of time. At the beginning and end of each menu     period participants provide blood and urine samples which we analyze to compare the effects     of each diet. More info at www.ProyectoCOMIDAS.info   "
146314|NCT01369160|"     The research proposed is a pilot study of pediatric and adolescent/young adult patients who     have received the curative intervention (MSD-SCT), disease-modifying interventions (HU or CT)     or SCC (control), with respect to three clinically important outcomes: quality-of-life (QOL),     neurocognitive function, and reproductive potential. Comparable cohorts will be identified     for each of the groups, drawing from patients treated by the SCD program of Children's     Healthcare of Atlanta (CHOA). QOL measures and neuropsychiatric testing and will be     administered. Reproductive endocrine function markers (laboratory studies and pubertal     staging), will be collected and analyzed. A tracking system of such patients will also be     developed, gathering available retrospective data and setting up a mechanism for collection     of new data.   "
146315|NCT01369147|"     Protein and/or energy deficits are associated with increased rates of hospital infection,     skeletal muscle weakness, impaired wound healing, and prolonged convalescence in ICU     patients. To prevent or treat malnutrition, enteral nutrition (EN) and/or parenteral     nutrition (PN) are routinely given worldwide to a significant proportion of ICU patients.     Optimal caloric requirements in critically ill patients are unknown due to a lack of rigorous     randomized clinical trials. The comparative efficacy of energy doses in critically ill     patients is unknown and clinical recommendations are conflicting and controversial; this     issue is the focus of our study.      The investigators have designed this pilot, single-center Randomized Clinical Trial (RCT) to     prospectively compare, for the first time, the clinical efficacy of different energy doses in     ICU patients requiring PN due to intestinal failure/dysfunction. A total of 60 patients will     be studied (20 per energy dose group) to generate critical preliminary data needed to inform     subsequent appropriately powered Phase III multicenter trials.      The primary aim of this study is to perform a controlled, double-blind, prospective,     randomized, intent-to-treat Phase II clinical trial to test the efficacy of three specific     energy doses [0.6, 1.0 and 1.3 x measured REE (resting energy expenditure), respectively],     given for 28 consecutive days during the ICU and post-ICU course, on 28-day total     hospital-acquired infections (primary endpoint), Blood Stream Infections ( BSI), and other     important clinical outcomes in medical/surgical ICU patients requiring specialized parenteral     ± enteral feeding. The investigators would also determine, in these subjects A) the impact of     cumulative and mean daily 28-day energy deficits [energy intake-measured REE] on clinical     outcome endpoints; and B) the practical utility of estimated REE determined by     Harris-Benedict equation versus measured REE across different energy doses. The investigators     would also like to determine the impact of administered energy dose and energy deficits on     global metabolomic patterns over time and their association with key clinical outcomes.      This study will allow us to generate needed data on the effect of energy dose and energy     deficits on global metabolomic patterns over time that may be associated with key clinical     outcomes in ICU patients. This exploratory research is also needed to develop new methods     that evaluate the metabolic responses to nutrition support and their potential relationships     to clinical outcomes.   "
146316|NCT01369134|"     Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and     dentin is as effective as a one-step etch and rinse approach.   "
146317|NCT01369121|"     This study is being conducted to evaluate the safety and tolerability of Xerecept® in     children with central nervous system tumors and to identify appropriate doses of Xerecept® to     be used in subsequent pediatric clinical trials.   "
146318|NCT01369108|"     Study hypothesis: a new, low polymerization stress flowable composite performs no differently     to a conventional, highly filled composite filling material when used as a restorative in     small cavities in back teeth.      Study will evaluate the clinical performance of a low shrinking flowable composite filling     material, compared with a conventional, highly filled composite restorative when used to     permanently fill small cavities in molar and premolar teeth in adult patients.   "
146319|NCT01369095|"     The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared     with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant     depression (TRD).   "
146321|NCT01369069|"     The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized,     controlled clinical trial of 1400 patients that will include approximately 60 enrolling     sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke     patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in     improved 3 month outcome after stroke.      Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and     glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will     include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites     from all over the United States. The study will evaluate the safety and efficacy of targeted     glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control     therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The     primary outcome will be functional outcome at 3 months as measured by the modified Rankin     Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40     mg/dL. Enrollment will occur over 3.5 - 4 years.   "
146322|NCT01369056|"     The general objective of this study is to evaluate HAART adherence in Estonia and the factors     affecting adherence; and the impact of an individual adherence enhancement counselling and     treatment monitoring model (Advanced Adherence, AdvAdh), compared to the regular counselling     received by HAART patients.   "
146323|NCT01369043|"     Moderate exercise is thought to be one of the best known means to improve how insulin works     in people. Taking vitamin C and vitamin E is also thought to have the same effect. This study     is being done to see if taking vitamin C and vitamin E improves or hinders how insulin works     when people do not exercise and when they do exercise.   "
146324|NCT01369030|"     This study will be an observational study in which patients who have been prescribed Deplin®     are invited to participate in surveys regarding their experiences with Deplin®. The purpose     of this study is to increase the understanding of the role of L-methylfolate among patients     who are candidates for Deplin®, provide patients with personalized education and support, and     contribute to the overall understanding of the needs and concerns of patients being treated     for depression.   "
146325|NCT01369017|"     The investigators want to see if healthy people who are given 2 doses of a medication called     anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then     exposed to a form of air pollution, called Endotoxin, have less inflammation with the     medication. Endotoxin is believed to be one of the causes of asthma attacks.   "
146326|NCT01369004|"     The purpose of this research project is to assess the efficacy of a weight loss intervention     for chronic disease prevention that focuses on daily self-weighing as the primary     self-monitoring strategy compared to a delayed-intervention control group. While daily     self-weighing has been shown to be effective for weight loss in observational research, there     is limited experimental evidence testing this association and most is derived from intensive     interventions that may overshadow the effects of self-weighing. To mitigate this, the     investigators will examine whether daily self-weighing is effective for weight loss under     self-directed conditions using a randomized-controlled design.      The investigators will conduct a 6-month randomized trial in 88 overweight and obese adults     to compare a daily self-weighing intervention to a delayed-intervention control group.     Changes in weight, diet and physical activity, and psychosocial measures will be examined.      Main Study Hypothesis: Participants in the group randomized to receive the daily     self-weighing intervention will have greater percent weight loss at 6 months compared to     those in the delayed control group.      Secondary Hypothesis: Participants in the group receiving the daily self-weighing     intervention will report greater engagement in diet and physical activity behaviors that     produce caloric deficits, greater self-efficacy and motivation, and no differences in body     satisfaction, disordered eating, or depressive symptoms compared to those in the control     group.   "
146327|NCT01368991|"     Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic     surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac     surgery patients at high risk for sternal wound complications. The investigators have     designed a randomized clinical trial of 48 high risk patients, with a 1:2 randomization of     kryptonite to conventional closure. The primary outcome will be quality of life. Secondary     outcomes include sternal complications, pain, hospital length of stay, and respiratory     function.   "
146328|NCT01368978|"     This study is a prospective, single-center, open label, randomized; two-arms cross over     study.      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin     delivery into the blood when the insulin is infused using an insulin-infusion pump by     controlled heating of the area surrounding the point of infusion.   "
146329|NCT01368965|"     This prospective, multi-center, single treatment clinical trial evaluates the clinical     outcomes associated with non-invasive treatment to obtain lift and tightening of facial     tissue and improve jawline definition in subjects with darker skin color utilizing the     Ulthera® System to deliver focused ultrasound energy below the skin surface.   "
146330|NCT01368952|"     Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI)     and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep Apnea.   "
146343|NCT01368783|"     Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in     Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with     tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to     investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and     Caucasian volunteers and compare the ethnic differences.   "
146344|NCT01368770|"     The use of coronary computed tomographic angiography(CTA)is rapidly increasing, but there is     lack of data which supports their use in the initial evaluation of patients who are     asymptomatic or mildly symptomatic. The hypothesis underlying this proposal is that the use     of stress-rest myocardial perfusion imaging (MPI) as an initial test for the evaluation of     asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events     will result in less further non-invasive and invasive testing and result in reduced costs,     without adversely affecting clinical outcomes in the short term.   "
146345|NCT01368757|"     In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide     in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started     once an optimal dose has been found. The primary endpoint will concern the efficacy of     lenalidomide in patients with CMML according to the WHO diagnostic criteria.   "
146331|NCT01368939|"     This research protocol is designed to evaluate a novel imaging camera, only one of three of     it's kind in existence, in the diagnosis of breast cancer. The Molecular Breast Imaging     Camera (MBI) is a gamma camera that images accumulation of 99mTc-Sestamibi, a     radiopharmaceutical with high affinity for tissues of high cellularity and mitochondrial     content; a common characteristic of breast cancers.      This camera represents a significant advancement over its predecessors as it has improved     imaging geometry since it can be in direct contact with breast tissue and improved gamma     photon detection capability through the use of cadmium zinc telluride (CZT) crystals (a     semiconductor material) instead of NaI used in standard gamma cameras.      This project involves imaging patients with a baseline population risk of breast cancer,     referred for myocardial perfusion imaging (MPI). This is possible because 99mTc-sestamibi is     also used to image myocardial tissue. After the MPI study is performed to standard clinical     specifications, the patient is simply imaged with the MBI.      The primary endpoint of this project is to assess acceptability of this imaging device by the     patient through the use of a patient survey. Secondary endpoints are to correlate any     findings on the MBI studies with standard breast imaging modalities including mammogram,     ultrasound, and MRI. Image quality will be evaluated by the interpreting physicians. Also, in     an effort to reduce radiation absorbed dose to the female breast, low injected dose images,     obtained through post-processing by reframing acquired images, will be assessed for     acceptable image quality and diagnostic accuracy.   "
146332|NCT01368926|"     This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the     pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In     Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either     RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy     Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523     or placebo orally daily for 14 days.   "
146333|NCT01368913|"     Desmopressin in treatment of nocturnal enuresis (bedwetting).   "
146334|NCT01368900|"     The purpose of this prospective, multi-center, single treatment study is to evaluate the     clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the     eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of     the skin.   "
146335|NCT01368887|"     The purpose of this study is to test the effectiveness of DermiPsor's DPS-102 (test product)     in patients with scalp Psoroasis. The study is also intended to assess the safety of the     product.   "
146336|NCT01368874|"     This prospective, multi-center, single treatment clinical trial evaluates the clinical     outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and     neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner     below the surface of the skin.   "
146337|NCT01368861|"     The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's     (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with     sucrose, during routine immunizations at 2 and 4 month well child visits.   "
146338|NCT01368848|"     Despite recent advances in the treatment of NSCLC overall survival within these patients     remains dismal and there is yet an unmet medical need for additional treatment options. In     this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and     bevacizumab) is tested to determine the objective response rate in patients with unresectable     and advanced non-small cell lung cancer. This response rate will be compared with historical     data.   "
146339|NCT01368835|"     The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment     to obtain lift and tightening of the cheek tissue and improve jawline definition and     submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a     focused manner below the surface of the skin   "
146340|NCT01368822|"     Several studies have shown that renal function in patients who have donated a kidney (but are     otherwise healthy) remains stable and within normal limits. However, it is unclear how donor     nephrectomy affects patient subsets with comorbidities, an issue that becomes relevant in the     current environment where inclusion criteria are continuously becoming less stringent and     more patients are being considered as potential donors.      In the present study, the investigators plan to evaluate long-term renal function in obese     patients who have donated a kidney as part of a living donor renal transplant procedure. The     investigators have selected this group because it is at higher risk for developing     obesity-related complications such as diabetes and hypertension that may impair renal     function, it is rapidly becoming a major subgroup in the kidney donor population, and no     studies have systematically followed obese patients after kidney donation. Establishment of     an appropriate control group is of primary importance in studies examining long-term     outcomes. The investigators will also evaluate a 2-kidney control group to allow us to     compare the individual and interactive effects of obesity and kidney donation on long-term     renal function. Study participants will complete a medical questionnaire, undergo blood     pressure measurements, and provide blood and urine samples for analysis of various metabolic     parameters. Some study participants will have ambulatory blood pressure monitoring performed     which involves application of an automated blood pressure cuff for 24 hours. Some study     participants will also undergo direct measurements of glomerular filtration rate (GFR) with     iohexol.      In the proposed research, the investigators hypothesize that obesity in kidney donors     increases the likelihood of developing renal dysfunction and risk factors for cardiovascular     disease (CVD) and may increase the likelihood even more than in healthy controls.   "
146341|NCT01368809|"     The purpose of this research is to evaluate the effectiveness of fentanyl for reducing     coughing during the perioperative period (i.e., insertion of an LMA [Laryngeal Mask Airway]     device, maintenance period during surgery, and awakening [emergence] from general anesthesia)     for ambulatory surgery procedures. Also to assess the effects of fentanyl on the     postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel     function [constipation], resumption of normal activities of daily living).      Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of     its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation     of the patient's airway.   "
146342|NCT01368796|"     Based on information from several years of looking at Influenza vaccination doctors know     that:        -  Older adults suffer the worst illness and most deaths caused by Influenza illness of all          age groups.        -  Older adults do not seem to get as good a level of protection as younger adults after          getting the usual seasonal Influenza vaccine.      Because of this information doctors wonder if one of the new seasonal Influenza vaccines is     more effective or more acceptable.      This study has been designed to answer some of these questions. On this study doctors will     compare 2 new vaccines against the usual seasonal influenza vaccine for protectiveness using     several different testing methods (including the usual tests) and for acceptability.   "
146347|NCT01368731|"     The hypothesis of this study is that prophylactic coagulation therapy with coagulation     forceps to visible vessels within the mucosal defect for colonic Endoscopic Mucosal Resection     (EMR) will reduce the rate of delayed bleeding when compared with current established     standard EMR technique.   "
146364|NCT01368510|"     Even with the best available treatments for obsessive-compulsive disorder (OCD), most     patients only partially recover and many patients do not respond at all. Such incomplete and     inadequate response contributes to greater public health costs in terms of morbidity and     patient care expenses. This study aims for a better understanding of abnormal brain chemistry     in OCD and how it is affected by cognitive-behavioral therapy (CBT) in order to develop novel     therapies and improve the success of existing therapies. The main hypothesis is that CBT will     change levels of the excitatory neurotransmitter glutamate in OCD patients in a region of the     brain involved in OCD known as the cingulate cortex.   "
146348|NCT01368718|"     Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be     induced or aggravated by underlying sleep disturbances. The relationship between sleep     quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep     quality on fatigue, a randomized controlled and cross-over trial with nasal continuous     positive airway pressure (nCPAP) is carried out in patients who present with a primary     complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index     (AHI) >= 15 on polysomnography (PSG).      The aim of this study is to address the issue of Continuous Positive Airway     Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with     obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness.     The answer to this question may shed further light on the enigmatic relationship between     sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure     responsiveness regarding sleepiness and general health in the same target population.     Zero-hypothesis: there is no effect.   "
146349|NCT01368705|"     The objective is to the amount of protein infants require after cardiopulmonary bypass     surgery.   "
146350|NCT01368692|"     The purpose of this study is to determine whether the shoulder retraction by placing a saline     bag between the scapula influences a success rate of subclavian vein catheterization.   "
146351|NCT01368679|"     This is a prospective multicenter observational study with 20 patients to evaluate the     performance of SCITECH stent for treatment of AAA. Will be enrolled the patient demographics,     laboratory tests, medical history, clinical evaluation, physical examination, adverse events.      The benefits and risks of the study should be explained before any specific test or procedure     of the study. The written consent must be obtained from the patient. No action specifies the     study should be performed while the patient has not signed the form of consent.   "
146352|NCT01368666|"     The primary objective of this clinical investigation is to assess the safety and     effectiveness of the Perceval S valve at 12 months after implantation when used to replace a     diseased or dysfunctional aortic valve or aortic valve prosthesis.   "
146353|NCT01368653|"     This clinical trials tests whether a new treatment designed to help smokers prepare to quit     smoking by practicing quitting several times helps more smokers quit and stay quit than     standard treatment with nicotine patch and smoking cessation counseling. The practice     quitting treatment being tested involves quitting for progressively longer periods of time     tailored to individual patterns of smoking. This clinical trial will also test whether     non-nicotine cigarettes can help smokers become smoke free after slipping during a stop     smoking attempt.   "
146354|NCT01368640|"     Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM     based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and     measurement data of the BIA devices on the other hand. The equations are necessary to use the     device as a Body Composition Analyzer with an acceptable accuracy level for clinical     practice.   "
146355|NCT01368627|"     E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the     treatment of unselected, high risk patients having coronary Artery blockage in the real world     clinical practice.   "
146356|NCT01368614|"     The purpose of this study is to evaluate the feasibility of using of the Average Volume     Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP)     and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed     with Obesity Hypoventilation syndrome.      The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will     yield daytime gas exchange values which are equivalent or no worse when compared to using     CPAP and bilevel PSV modes of ventilation in the OHS population.   "
146357|NCT01368601|"     This is a randomized placebo-controlled trial studying the effects of intraoperative     continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer     undergoing lobectomy.   "
146358|NCT01368588|"     RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation     therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy     x-rays to kill tumor cells.      PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation     therapy in treating patients with prostate cancer.   "
146359|NCT01368575|"     The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate     and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact     on heart failure and progress of mitral regurgitation.   "
146360|NCT01368562|"     This is an open label compassionate use study of subcutaneously administered MNTX in subjects     with advance medical illness and opioid-induced constipation. Eligible subjects were to     initially receive a single dose of MNTX delivered SC. Subsequent dosing could have been     adjusted upward to achieve a desired clinical response or lowered to alleviate drug related     adverse events (AEs).   "
146361|NCT01368549|"     This study will be an observational study in which patients who have been prescribed Metanx®     are invited to participate in surveys regarding their experiences with Metanx®. The purpose     of this study is to increase the understanding of the role of Metanx® in managing diabetic     neuropathy, provide patients with personalized education and support, and contribute to the     overall understanding of the needs and concerns of patients being treated for diabetic     neuropathy.   "
146363|NCT01368523|"     The purpose of this study is to provide patients with imatinib resistant/intolerant chronic     myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been     previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib     (AMN107) in Poland until such time as the treatment with this drug is financed by the     National Health Found in Poland (via 'therapeutic program') or for a period of 18 months,     whichever comes first.   "
146365|NCT01368497|"     The purpose of this study is to determine the safety and efficacy of treatment using a     combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old     with immunotolerant chronic hepatitis B.   "
146366|NCT01368484|"     The aim of this study is evaluated the effect of dietetic supplementation with DHA on human     sperm quality, antioxidant capacity and sperm DNA damage.   "
146367|NCT01368471|"     The goal of this study is to demonstrate the superiority of the MGuard™ stent over     commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better     myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation     myocardial infarction (STEMI).   "
146368|NCT01368458|"     This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to     determine whether patients with chronic schizophrenia or schizoaffective disorder receiving     two different antipsychotics simultaneously will have any significant change in     psychopathology following conversion to antipsychotic monotherapy. Additionally, the effects     of conversion to antipsychotic monotherapy will be assessed by neurocognitive tests.      The study will be conducted at the Clinical Research and Evaluation Facility (CREF), a     specialized research unit jointly operated by the Nathan S Kline Institute for Psychiatric     Research (NKI) and Rockland Psychiatric Center (RPC). Patients will be recruited from the     regular in-patient units of RPC and transferred to the CREF. Following baseline assessments,     patients will be randomized to continued antipsychotic polypharmacy treatment or to     systematic conversion to monotherapy.      Conversion to antipsychotic monotherapy will be assessed across multiple domains of     psychopathology using the Positive and Negative Symptom Scale (PANSS). The primary outcome     measure is PANSS total score. The secondary outcome measure is time on medication (all-cause     dropouts). Mixed Model Repeated Measures (MMRM) will test the hypothesis that conversion to     antipsychotic monotherapy will show minimal change from the control group.   "
146369|NCT01368445|"     The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine     hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice     daily in patients with seasonal allergic rhinitis.   "
146370|NCT01368432|"     This research is being done to see if a drug called escitalopram (Lexapro) is helpful to     people who are suffering from depression after traumatic brain injury (TBI).   "
146371|NCT01368419|"     This study is to explore the clinical efficacy of continuous Endostar infusion combined with     radiotherapy in esophageal cancer patients.   "
146372|NCT01368406|"     The aims of this study were to evaluate the efficacy of an intervention for weight gain     management for patients from schizophrenia spectrum compared to treatment as usual (TAU), and     to evaluate the effects of this program on metabolic profile, symptoms and quality of life.   "
146373|NCT01368393|"     Background:      Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA)     has been used successfully to treat pain of various origins, but few good-quality studies     have evaluated its role in treating pain and anxiety during colonoscopy.      Objective:      To investigate the efficacy of EA in reducing procedure-related pain and the consumption of     sedatives/analgesics during colonoscopy.      Design:      Prospective, randomized, double-blind, sham-controlled study.      Subjects:      One hundred and twenty eight consecutive patients undergoing first-time elective day-case     colonoscopy without previous experience of acupuncture will be recruited.      Interventions:      Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA)     before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including     Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed     (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to     stabilize the needles and to blind the patients and endoscopists to the treatment allocation.     EA and SA will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil,     delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both     groups.      Outcome measures:      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes:     pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time,     and episodes of hypotension/desaturation.   "
146374|NCT01368380|"     This study evaluates the effect of a psychological intervention to breast cancer patients and     their partners compared to a control group receiving usual care   "
146375|NCT01368367|"     The purpose of this study is to determine whether a high intensity aerobic and resisted     exercise program will improve physical, functional and psychological outcomes in patients     post burn injury.   "
146376|NCT01368354|"     Summary Diseases due to T. solium and soil transmitted helminths (STHs) are of cosmopolitan     distribution and strongly linked with poor sanitation and poverty. These infections are to a     great extent perpetuated by open defecation (OD). Community-Led Total Sanitation (CLTS) is an     approach in which people in rural communities are facilitated to do their own appraisal and     analysis, come to their own conclusions, and take their own actions. To date no rigorous     study has been conducted to evaluate the impact of CLTS on the transmission of     taeniasis/cysticercosis or STHs, despite the worldwide acclaim which CLTS has received as an     approach to improve sanitation. The overall aim of the study is to contribute to the     reduction and subsequent control of T. solium and STH infections through the implementation     of CLTS approaches in 1 districts in the Eastern Province of Zambia. By using CLTS it is     hypothesised that toilet acquisition and usage will be increased with a resultant reduction     in OD which will in turn reduce the transmission of T. solium and STH infections in the     district. This will be measured by porcine/human cysticercosis prevalence (serological test)     and STH infections in humans (quantitative coprological test).   "
146377|NCT01368341|"     Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection.     Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement     about what antibiotic treatment that should be given. An RCT with the three most common     antibiotics used, will support data for revision of national guidelines.   "
146378|NCT01368328|"     The role of micronutrients in diabetes is not well understood. Studies have demonstrated the     relationship between low chromium serum levels and insulin resistance. This study aims to     evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with     type 2 diabetes.   "
146379|NCT01368315|"     A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327     in the Atopy Patch Test model.   "
146442|NCT01367496|"     This is an open-label, Phase I study. Study treatments will entail a four-way crossover among     three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy     normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics,     dose proportionality for subcutaneous doses, and absolute bioavailability versus an     intravenous dose.   "
146380|NCT01368302|"     Patients with Post Traumatic Stress Disorder (PTSD) will be randomly assigned to either     Attention Bias Modification Treatment (ABMT) designed to normalize threat-related attention     biases or a placebo control condition not designed to change attention patterns. Outcome     measures will be Post Traumatic Stress Disorder (PTSD), depression, and anxiety symptoms as     measured by gold standard questionnaires and symptom counts derived from structured clinical     interviews.      We expect to see significant Post Traumatic Stress Disorder symptom reduction in the     Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in     which no symptomatic relief is expected.   "
146381|NCT01368289|"     A prospective, multicentre, observational study of all patients referred for endoscopic     resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat     analysis.   "
146382|NCT01368276|"     The purpose of this study is to learn about the safety and the risks of using talimogene     laherparepvec in patients who already received treatment with talimogene laherparepvec in     study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec     can destroy melanoma tumors.   "
146383|NCT01368263|"     This phase II trial studies the impact of a presurgical endocrine therapy, consisting of     goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage     II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2     (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body.     E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth.     Giving goserelin together with letrozole or anastrozole before surgery may enhance the     effectiveness of, or eliminate the need for, chemotherapy   "
146384|NCT01368250|"     Aortic valve stenosis represents the clinically most important valvular heart disease in the     elderly patient population. For several decades, surgical aortic valve replacement has been     considered the standard in the treatment of symptomatic patients with aortic stenosis.     Patients deemed at excessive-risk for conventional aortic valve replacement were treated     conservatively with a very poor prognosis. In the search for less invasive treatment options     for this elderly patient population, transcatheter aortic valve implantation (TAVI) was     introduced in 2002 and since then has been established as an alternative, less invasive     treatment option for non-operable or high-risk patients for conventional surgery. The purpose     of this prospective multi-center, observational national registry in Switzerland is to obtain     clinical baseline, procedural and follow-up data of all patients treated with TAVI in     Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved     devices. All centers in Switzerland implanting the CE approved devices for TAVI will be     invited to include patients in the registry. Each site will collect baseline and procedural     data as well as clinical outcome data up to five years.   "
146385|NCT01368237|"     Recent advances in technology have resulted in the development of scanners that can image the     heart blood vessels within 10 to 20 minutes but without the need for admission to hospital or     insertion of catheters. Further advances in technology allow the visualisation of both the     blood vessels and the supply of blood to the heart muscle. Here we propose to assess the     latest and most powerful computed tomography scanner and compare it to magnetic resonance and     conventional coronary angiography.   "
146386|NCT01368224|"     In recent decades, the incidence of subjects presenting reactive skin has considerably     increased in industrialized countries. Probiotics are live microorganisms which, when     ingested in sufficient amounts, have beneficial effects on human health. The mechanism     underlying the effect of probiotics involves, in part, regulation of the composition and/or     metabolic activity of the intestinal microbiota.. It is postulated that following interaction     of probiotics with the intestinal epithelium, associated intestinal cells become activated     and consequently mediators are released into the blood circulation. Mediators, activated     intestinal epithelial cells and possibly bacterial fractions might reach the skin through the     bloodstream where they potentially could exert effects.The objective of this study was to     assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus     paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum     NCC3001 in a randomized, double-blind study. The two strains were selected for their     immune-modulatory properties demonstrated in in vitro and other preclinical studies as well     as in a pilot clinical trial.      Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L.     paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The     supplements were administered by the oral route for 58 days (1010 CFU/day).      The objective of the clinical trial was to determine, in vivo, the effect of food supplements     on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier     function post-repeated tape stripping).      The secondary objectives were to determine the effect of the food supplements on leg skin     dryness and facial skin roughness and the associated biochemical, immunological and     microbiological factors.      Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The     reconstruction of barrier function was determined by measuring the trans-epidermal water loss     (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin     dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg     and facial skin dryness themselves. Each analysis was conducted at the various time points.      In parallel, assessment of the skin moisturizing factors and serum inflammatory and     immune-regulatory cytokines were performed. Finally, key components of the intestinal     microbiota were analyzed.   "
146387|NCT01368211|"     The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen     that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet     products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the     correlation between the TEG® parameters and platelet count increments after platelet     transfusions in thrombocytopenic subjects.   "
146388|NCT01368198|"     The primary objective of this investigation will be to quantify the increase in tear film     break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular     Emulsion in dry eye sufferers.   "
146389|NCT01368185|"     This was a retrospective, chart review, observational study to assess the effect of MK-0954A     (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period     of at least three months on serum uric acid levels.   "
146390|NCT01368172|"     The first evidence-based physical activity guidelines for people with spinal cord injury were     released in March, 2011. This project will evaluate the implementation of the new physical     activity guidelines in a community exercise setting in Hamilton, Ontario. The investigators     hypothesize that persons who follow the guidelines will experience increased aerobic fitness     and muscle strength. The investigators also hypothesize that participants will find the     guidelines easy to follow and that their self-efficacy for participating in physical activity     will be improved following the study period.   "
146443|NCT01367483|"     This is an open-label, radiotracer study, to be conducted in healthy, normal, male     volunteers. It will entail intravenous administration of a single dose of 14C-MNTX,     collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be     sampled as a measure of the extent of possible metabolic MNTX demethylation.   "
146391|NCT01368159|"     The trial objectives are to compare efficacy relative to pain, along the route of the vein     following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous     vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg)     versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be     the comparison between the first two groups mentioned. All other contrasts will be secondary.     The Class I compression versus The two class III compressions contrast will also be     studied.      Efficacy will be measured by totalling the VAS scores for maximum pain experienced since the     morning and evaluated by the patient at the end of the day.      Consumption of analgesics or the number of days of analgesic treatment necessary for the 3     compression types used will be compared.      One of the trial objectives is also to show that regular use of a class III compression     product leads to a reduction in complications following sclerosis (by reducing the number of     non-serious/serious complications specific to sclerosis: matting, pigmentation, inflammation,     development of sclerosis requiring drainage, DVT, pulmonary embolism, etc.). The trial also     aims to compare the rate of successful sclerosis between the three devices, success being     defined by complete or partial occlusion of the great saphenous vein, leading to the     disappearance of reflux at the crural level.      The other secondary objectives will be patient evaluation of comfort, ease of putting on and     taking off the compression hose and a global appreciation of the procedure for echoguided     endovenous injection of sclerotherapeutic foam into the great saphenous vein, followed by     wearing compression hose.   "
146392|NCT01368146|"     The purpose of this study is to determine whether contact sensitization occurs to the skin of     normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and     Silicone Vehicle Control dressings.   "
146393|NCT01368133|"     The major purpose of this study is to evaluate the changes of multiple organs in patients     with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples     and pituitary tumor tissues will be kept for further analysis.   "
146394|NCT01368120|"     The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV     Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.   "
146395|NCT01368107|"     The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4     lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic     breast cancer patients.      The primary objective is to determine the optimal schedule to deliver CYT107 during     chemotherapy based on restoration of CD4 count.      This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.      24 patients will be included in the study.   "
146396|NCT01368094|"     Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This     intervention is associated with a high rate of postoperative complications including:        -  pancreatic fistulas (PF);        -  surgical site infections (intra-abdominal abscess, wound infection);        -  delayed gastric emptying (gastroparesis);        -  and hemorrhage.      The incidence of SSI (superficial and deep) is about 35% and seems influenced by the     prolonged intra-abdominal drainage. For several years, there has been a global trend to     reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical     trials have shown that prophylactic drainage does not decrease the incidence of postoperative     complications during elective hepatectomy, colectomy, and cholecystectomy and could increase     the number of SSI. However, the role of prophylactic drainage after PD is so far unclear.      The aim of this prospective randomized multicenter study is to evaluate the influence of     early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice)     drainage removal of the abdominal cavity after PD, on the rate of SSI.      Materials and Methods: The technique of PD is left at the discretion of the operator as well     as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of     one or two round silicone close suction drains or open multichannel silicone drains placed in     the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated     on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd     postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In     case of pancreatic fistula, the patient is excluded from randomization and drainage of the     abdominal cavity is left in place depending on the different teams' practice. Patients     without fistula are randomized to either drainage removal 4 days after surgery (D4) or     standard drainage.   "
146397|NCT01368081|"     The objective of the study is to investigate the long-term safety and efficacy of BI 10773     given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2     diabetes mellitus with insufficient glycaemic control.   "
146398|NCT01368068|"     Many perimenopausal women experience severe mood symptoms for the first time in their life,     with no past psychiatric history. The importance of clearly identifying and treating a     disorder that is increasingly referred to as perimenopausal depression is highlighted by     the wide-reaching impact this can have on the lives of women suffering from it. This is not a     minor or short term mood disturbance; it is a severe depressive illness, needing effective     and early treatment. Relationships, employment, participation in social roles and individual     well-being can all be disrupted by the combination of the mood, hormonal and physical changes     associated with the transition to menopause. The term perimenopausal depression denotes the     onset of depression coinciding with the onset of reproductive hormone changes.      Many women with this type of depression experience serious and long term debilitating     symptoms. Treatment commonly draws on traditional approaches for the management of major     depression including the use of antidepressants such as selective serotonin reuptake     inhibitors (SSRIs) as the first line response. However, standard treatment of perimenopausal     depression using antidepressants has only shown small improvements at best and at worst, is     associated with severe side effects. Some SSRIs have been shown to be less effective in     postmenopausal women compared to child bearing age women. Hormone treatments directly     targeting the fluctuating reproductive hormone systems (in particular estrogen) through the     administration of compounds such as tibolone, have significant potential as a better overall     treatment.      To date, there is still a lack of clear clinical evidence about the best approach for the     biological treatment of women with perimenopausal depression. The project we now propose to     conduct is a 12-week randomised controlled trial (RCT) of 2.5 mg/day tibolone compared to     10mg/day of escitalopram (an SSRI that has targeted serotonin action)compared to placebo to     discover the best treatment approach for a hitherto understudied depression that affects a     large proportion of women in their late forties and fifties.   "
146399|NCT01368055|"     The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that     has as little side effects on normal bladder and rectal tissues as the usual longer course (8     weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.   "
146424|NCT01367730|"     In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone,     as well as changes in cortical porosity will play a major role, and thus also affect bone     strength. In developing therapeutics the response of individual compartments, regional     variations post-therapy will have considerable impact on selecting the therapies as well as     monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay     the ground-work for the future.   "
146401|NCT01368029|"     This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus     rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated     influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of     several strains of Lactobacilli that is used as a probiotic or microorganism administered to     confer health benefits. Our research is focused on studying the possible therapeutic     effects of LGG. The study hypotheses are:        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly          subjects who have just received the trivalent inactivated influenza vaccine        2. The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the          influenza season will be higher in the LGG group than the placebo group        3. The occurrence rate of influenza like illness during the influenza season will be lower          in the LGG group than in the placebo group        4. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56          and at the end of the influenza season will be greater in the LGG group than the placebo          group.   "
146402|NCT01368016|"     A comparison of two products for oral nicotine replacement with respect to relief of urges to     smoke after single doses of nicotine.   "
146403|NCT01368003|"     In this research study, the investigators are looking to determine the safety and efficacy of     an investigational drug, STA9090 alone and in combination with dutasteride for the treatment     of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to slow down or     shrink by targeting proteins required for the cancer to grow. The investigators are also     looking to determine whether the use of dutasteride to lower male hormone levels will enhance     the effect of STA9090 in the treatment of castrate resistant prostate cancer.   "
146404|NCT01367990|"     The study will evaluate the safety of topical norepinephrine in head and neck cancer patients     who are receiving treatment with intensity modulated radiotherapy (IMRT).      The study will also provide information about whether topical norepinephrine can prevent or     decrease the severity of the radiation-induced alopecia experienced by these patients.   "
146405|NCT01367977|"     It is known that 33-50% of Classic and Hypermobile Ehlers-Danlos Syndrome patients eventually     develop dysautonomia, otherwise known as POTS (Postural Orthostatic Tachycardia Syndrome).     Some of these patients develop dysautonomia as a result of a retroflexed odontoid, Chiari 1     Malformation or cranial settling and the resulting basilar impression. Many Ehlers-Danlos     patients suffer with the same symptomology with no evidence of a cause according to MRI     imaging.      It is the author's hypothesis that low-level External Communicating Hydrocephalus appears to     be responsible for the constellation of autonomic and cranial nerve symptoms, and if present     in the very young, an analysis of head circumference growth in the first 15 months of life     should reflect abnormally rapid head growth, supporting this hypothesis.   "
146406|NCT01367964|"     West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three     features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on     electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this study     is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether treatment     with ACTH will prevent WS.   "
146407|NCT01367951|"     Unstable chest injuries are common in poly trauma patients. They can lead to severe pulmonary     restriction, loss of lung volume, difficulty with ventilation and can render the patient to     require intubation and mechanical ventilation. Traditionally these injuries have been treated     non-operatively, however in the past decade there has been numerous studies suggesting     improved outcomes with surgical fixation. Surgical fixation can significantly decrease time     spent in ICU as well as day on mechanical ventilation. The investigators aim is to conduct a     randomized control trial of these injuries, to compare non-operative treatment with surgical     fixation. The investigators' hypothesis is that surgically treated patient will have     significantly improved outcomes compared to those treated non-operatively.   "
146408|NCT01367938|"     This study tracks the clinical outcomes associated with the OK knee Total Knee Arthroplasty     (TKA) system.   "
146409|NCT01367925|"     This study compares the clinical and radiographic outcomes obtained with the use of the     Stryker Triathalon Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.   "
146410|NCT01367912|"     To test the hypothesis that adding estradiol (E2) to progesterone supplementation later in     the luteal phase of in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)     cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (PRs).   "
146411|NCT01367899|"     The objective of this post-approval study is to provide scientifically valid and reliable     evidence that supports claims of longer term safety and effectiveness with regard to Month     120 device survivorship rates.   "
146412|NCT01367886|"     This study is being done to evaluate the use of a new technology (urine proteomics) - the     study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a     simple voided urine specimen.   "
146413|NCT01367873|"     This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose     study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196     in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses     of VIA-3196 or matching placebo.   "
146437|NCT01367561|"     This is a double-blind, randomized, study at a single clinical site investigating the effect     of methylnaltrexone and naloxone versus placebo in healthy males who have received a     short-acting opioid, remifentanil.   "
146438|NCT01367548|"     A double-blind, randomized, parallel-group study designed to evaluate the safety and activity     of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental     colectomies via laparotomy.   "
146439|NCT01367535|"     This study is a single-center, randomized, open-label, active and placebo-controlled,     parallel-group, conducted in healthy male volunteers who have been shown to be extensive     metabolizers of dextromethorphan.   "
146440|NCT01367522|"     This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will     receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight     subjects from each classification of hepatic impairment will be enrolled. Plasma samples will     be collected before and at specified intervals after dosing and the concentration of MNTX     will be analyzed.   "
146414|NCT01367860|"     Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by     disc herniation.      Among the various surgical techniques practiced the percutaneous discectomy occupies its     space since the first description of the technique by Hijikata, 1975. Throughout, many     techniques have been described. Studies indicate that the treatment was successful for pain     and disability resulting from herniated disc associated with radiculopathy small.      However, some methods remove very small amounts of tissue with little change in volume of the     disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed more     macroscopic changes of the disc with a predictable amount of removal and significant disc     material.      The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy which     creates a suction effect in tissues adjacent to the exit point of the fluid and the opening     point of the collector. However, no studies have examined the effect of the Percutaneous     Diskectomy by SpineJet ® in humans about the disk size after treatment or measures of disc     degeneration by imaging methods or how these characteristics might correlate with clinical     outcomes.      Thus, the study will compare outcomes of patients with contained or extruded disc herniation,     with complaints of radiculopathy, concordant with the imaging findings. With treatment by     surgical technique or the traditional by SpineJet ®, in order to determine whether     percutaneous discectomy with SpineJet ® will produce results comparable to open     microdiskectomy.   "
146415|NCT01367847|"     The aim of this pilot study is to determine whether a technology-enhanced version of an     established behavioral treatment protocol, Helping the Noncompliant Child (HNC; McMahon &     Forehand), enhances the engagement and treatment outcomes of lower income parents of 3 to 8     children with externalizing problems in treatment. It is predicted that families in both the     HNC and technology-enhanced HNC (TE-HNC) programs will evidence significant improvement in     parenting behavior and child externalizing problems; however, it is predicted that     parent-child dyads in the TE-HNC program will require fewer sessions, will be more likely to     be retained in the program, will be more likely to remain engaged in the program (e.g.,     practicing skills between sessions etc.), and will be more likely to have active involvement     from their coparenting partners (i.e., other adults and family members who participate in     childrearing).In turn, it is expected that the TE-HNC program will boost treatment outcomes.   "
146416|NCT01367834|"     The purpose of this research study is to learn about brain development in very young girls     with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain     development.   "
146417|NCT01367821|"     Patients with obstructive jaundice (OJ) often require surgical, endoscopic or radiological     interventions to facilitate biliary drainage and relieve jaundice. However it is known that     patients with OJ have increased surgical risks than non-jaundiced patients undergoing the     same procedures. Surgery for severe OJ is associated with a significant post-operative     mortality (10-15%) and morbidity (30-65%). The commonest complications are related to sepsis     but the pathophysiological mechanisms behind this susceptibility to bacterial infection are     not clear. Recent work has shown a pivotal role of bile in the maintenance of enterocyte     tight junctions and the expression of tight junction-associated proteins which could account     for the translocation of enteric bacteria and bacterial products to mesenteric lymph node     complexes, the portal circulation and subsequently the liver. Some of these bacterial     products, such as endotoxin and quorum sensing signalling molecules (QSSMs), have     immunomodulatory properties which may dampen normal immune responses to infection resulting     in life-threatening organ dysfunction. Bacterial endotoxin and quorum sensing signalling     molecules (QSSMs) represent good candidates for the mediators of this immune suppression and     although there is a compelling case for their involvement in the pathogenesis of sepsis,     evidence to support their involvement in the aetiology of infection in OJ is currently     lacking.   "
146418|NCT01367808|"     Variability in drug response can be due to either pharmacokinetic or pharmacodynamic factors.     The reasons why people differ in pharmacokinetics or pharmacodynamics are manifold and     include, e.g., genetic factors, diseases, age and concomitantly administered drugs. Oxidation     reactions are dominant in the metabolism of drugs and cytochrome P-450 enzymes (CYP) have     been recognized as chief contributors. We have previously shown that drug interactions     mediated by the inhibition of CYP enzymes may be of major clinical significance.      This study is aimed to examine the possible interactions of low-dose sublingual buprenorphine     with posaconazole and voriconazole.      The study will be conducted using a randomized, balanced cross-over design in three phases.      Twelve male or female adult non-smoking subjects aged 18-40 years with body weights within     ±15% of the ideal weight for height will be recruited for the study. The subjects will be     submitted to physical examination, determination of previous or present chronic diseases, and     comprehensive laboratory testing to ascertain that they are in good health. The subjects will     fill in a modified Finnish version of the Abuse Questions to assess their vulnerability for     opioid abuse. Laboratory screening will include CBC (including hemoglobin, hematocrit,     differential WBC, platelet count), SGOT, SGPT, alkaline phosphatase, BUN and creatinine, and     for women a pregnancy test. Urine will be screened for glucose, proteins and drugs with     addiction potential. Blood pressure in sitting position must be within normal limits. Base     line ECG must be normal.      The subjects will be given in a randomized, cross-over, balanced manner at intervals of four     weeks either placebo, vorikonazole or posakonazole. On day 5, the challenge dose of 0.4 or     0.6 mg of sublingual buprenorphine (Temgesic, Schering-Plough) will be administered at 11.00,     i.e. 1 h after the last dose of placebo, voriconazole or posaconazole. The dose is 0.6 mg     after placebo and 0.4 mg after posaconazole and voriconazole. If necessary, naloxone     (Naloxone B. Braun, Braun) will be given in sufficient doses to counteract the severe adverse     effects of buprenorphine. For nausea and vomiting, intravenous tropisetron will used, if     needed.      On day 4, a forearm vein will be cannulated with a plastic cannula for blood sampling. Timed     venous blood samples will be drawn before the administration of buprenorphine and 0.5, 1,     1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18-20 hours after administration. Another venous cannula     will be inserted to the opposite forearm for the intravenous administration of naloxone.     Urine will be collected for 18-20 hours.      The psychomotor effects of buprenorphine will be assessed with visual analog scales (Bond and     Lader 1974) and digit symbol substitution test (Stone 1984) at 1-2 hour intervals up to 12     hours after buprenorphine administration. Visual analogue scales will be used for the     following items: alert / drowsy, good / poor performance, no / strong drug effect, unpleasant     /pleasant feeling, no / extreme nausea. For each pharmacodynamic variable, the area under the     response-time curve will be determined by trapezoidal rule for 12 hours.      The analgesic effect of buprenorphine will be evaluated using the cold pressor test.   "
146419|NCT01367795|"     Patients in a known palliative setting and with localized symptoms due to tumor growth will     be evaluated for their quality of life before and after a surgical intervention (primary     endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a     intensive care unit, complications, reinterventions will be recorded (secondary endpoints).     The investigators will also observe patients with conservative treatment.   "
146420|NCT01367782|"     The purpose of this study is to test the effects of low frequency deep rTMS using the novel     H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's     disease (PD), to establish its safety in this population and to test effects of maintenance     treatments.   "
146421|NCT01367769|"     Background:      Contrast-enhanced ultrasound (CEUS) visualization of the adventitial vasa vasorum. Late phase     CEUS detect inflammation by visualizing microbubbles phagocytosed by monocytes. The     inflammatory process of the vessel wall associated with perivascular angiogenesis at the time     of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may important in     the development of post-thrombotic syndrome (PTS). Therefore the investigators will test the     value of CEUS to detect venous perivascular vascularization and inflammation in patients with     acute DVT or SVT.      Aims:      To determine the presence and degree of venous perivascular vascularization and inflammation     assessed with CEUS in patients with acute DVT or SVT, and compare this to controls without     thrombosis.      Expected results:      The investigators hypothesize that venous perivascular vascularization and inflammation     assessed by contrast agent enhancement can be quantified and will be significantly more     pronounced in the perivascular tissue of the thrombotic vein than in the non affected vein     and in controls, and will correlate with level of inflammatory markers and leg volume.      Significance:      These results would provide new information on the pathophysiological concept of thrombosis     and thrombus resolution. It might help to better understand the pathophysiologic mechanisms     that promote the development of chronic venous insufficiency and PTS.   "
147365|NCT01355354|"     The purpose of this study is to investigate the drug interaction between fostamatinib and     digoxin by comparing the safety, tolerability and plasma concentration of digoxin when     administered alone and with fostamatinib in healthy subjects.   "
146422|NCT01367756|"     This randomized, double-blind, parallel-arm study will assess the safety and tolerability of     RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive     citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo     in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.   "
146423|NCT01367743|"     The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after     reperfused myocardial infarction will be compared, by following cardiac index evolution as     main criteria. The study is a pilot pathophysiological study, randomized, double blind and     multicenter.   "
146425|NCT01367717|"     Background: Creatinine (Crn) concentration is used to assess renal function via calculation     of GFR (Glomerular Filtration Rate). By RIFLE (Risk, Injury, Failure, Loss, End Stage Kidney     Disease) criteria, acute kidney injury (AKI) and acute renal failure (ARF) are defined by a     two-fold and three-fold increase in serum Crn, respectively. Crn is a breakdown product of     proteins and circulating creatine, and it is generally a benign product present in serum.     Creatine is a nutritional supplement that has been available since 1993, and it is widely     used among athletes today.      Methods: In an IRB approved, blinded crossover trial, 25 human volunteers ingested 2 creatine     supplements to determine any associated statistically significant increase in serum Crn and     clinically significant increase in serum Crn to a degree associated with AKI or ARF. Urine     samples were also collected to examine excretion patterns after an ingested sample.     Participants ingested 10 gm of creatine ethyl ester (CEE) or creatine monohydrate (CrM) and     had serum Crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. Urinary Crn levels were assayed at 0,     1.5, 3, 5 and 24 hours. Exclusion factors were any history of renal disease or use of     creatine within the last month. Statistical analysis was performed by Wilcoxon Matched-Pair     Signed Ranks Test and descriptive summary statistics were performed.   "
146426|NCT01367704|"     Despite the high prevalence of adolescent relationship abuse (ARA) reported among adolescent     females and substantial reports of perpetration by young males, effective prevention programs     to prevent ARA are limited. Male athletes are an important target for prevention efforts     given their higher rates of abuse perpetration compared to non-athlete peers as well as their     social influence among their peers. This cluster-randomized school-based investigation     examines the effectiveness of a program for the primary prevention of ARA. Coaching Boys     into Men (CBIM) is a social norms theory-based program intended to alter norms that foster     ARA perpetration, promote bystander intervention, and reduce ARA perpetration by engaging     athletic coaches as positive role models to deliver violence prevention scripts and tools to     high school age male athletes. Coaches receive a 60-minute training session to administer the     intervention to their athletes via 11 lessons across a sport season. Trained high school     coaches talk to their male athletes about 1) what constitutes disrespectful and harmful vs.     respectful behaviors, 2) promoting more gender-equitable attitudes, and 3) modeling bystander     intervention when disrespectful behaviors toward women and girls are witnessed. The current     investigation evaluates the intervention in 16 urban high schools randomized either to     receive the CBIM program (i.e., intervention schools, n=8) or to a control condition (n=8).     Baseline computer-based surveys are collected for all intervention and control site student     athletes entering grades 9 through 12 at the start of each of three sports seasons across     Year 1 (Time 1). Follow up surveys are collected for these same athletes at the end of their     first sports season (Time 2). Participating athletes in grades 9 - 11 at baseline are     re-surveyed 12 months after Time 1 to examine the longer term effects of the CBIM     intervention (Time 3; N of athletes completing all 3 waves of data collection = 1500).     Primary assessment of intervention effects are based on intent-to-treat estimates, utilizing     generalized linear mixed models to account for clustering arising from school randomization.     Hypothesized outcomes for male athletes include a) an increase in recognition of what     constitutes abusive behaviors, b) more gender-equitable attitudes, c) an increase in     intentions and reports of bystander intervention regarding ARA, and through these     intermediate outcomes, d) a decrease in perpetration of ARA among adolescent male athletes.   "
146427|NCT01367691|"     Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients     with CRT.      Goals are to demonstrate that        -  differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences          in myocardial activation        -  differences in LV-RV pacing delays cause differences in LV/RV hemodynamics      and to use these data to optimize CRT.   "
146428|NCT01367678|"     In the following randomized non-crossover study, the investigators test the hypothesis that     directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and     the i-Gel in paralyzed anesthetized females.      Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA     Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA     Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx;     C, hypopharynx; and D, pyriform fossa.      Insertion success rate and oropharyngeal leak pressure were also measured.   "
146430|NCT01367652|"     The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted     conditions.   "
146431|NCT01367639|"     Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a     substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be     detected. The only proven modality for active risk reduction (rather than passive early     detection), is prophylactic surgery - prophylactic mastectomy and oophorectomy. While the     majority of Jewish mutation carriers elect to undergo prophylactic oophorectomy at about age     40 years, in Israel only a minority perform prophylactic mastectomy. Another ramification of     being a mutation carrier is the emotional stress associated with that discovery.Genetic     information has profound implications for mutation carriers. The IBSR (Inquiry-based stress     reduction) intervention, developed by Byron Katie, trains participants to reduce their     perceived level of stress by self-inquiry of their thoughts and beliefs connected to     stressful circumstances or symptoms. This meditative process, named The Work, enables the     participants to identify and question the stressful thoughts that cause their suffering. The     core of IBSR is simply four questions and a turnaround, which is a way of experiencing the     opposite of what the participant believes. This process is simple, powerful and provides     skills for self-inquiry and management of stressful thoughts that can be easily implemented     in daily life [ ]. Therefore, on the basis of previous data and beneficial observations we     postulate that the clinical utility of IBSR mediation program may improve psychological and     physical symptoms and quality of life among asymptomatic (oncologically healthy) BRCA1/ BRCA2     mutation carriers. Thus, we will conduct a pilot randomized controlled trial to     scientifically investigate the effect of this intervention effects on BRCA1/2 mutation     carriers.   "
146432|NCT01367626|"     The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed     conditions.   "
146433|NCT01367613|"     This is a 3 month open-label extension study that allows patients who completed Protocol MNTX     302 to receive SC MNTX.   "
146434|NCT01367600|"     This study is an open-label extension allowing patients who have completed Protocol MNTX 301     to continue to receive SC MNTX.   "
146435|NCT01367587|"     This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.   "
146436|NCT01367574|"     This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous     methylnaltrexone to be conducted in patients with advanced medical illness and poorly     controlled opioid induced constipation. Patients will be randomized to one of three fixed     dose levels of SC MNTX.   "
146444|NCT01367470|"     The newborn immune system is influenced by maternal immunity through both placenta and     breastfeeding.      There exists a close interaction between the mother and the baby during gestation and     lactation. Maternal milk contains a number of factors that protect the newborn against     infections including 1) cytokines and their receptors which are also thought to play a role     in the protection against allergies; 2) oligosaccharides with low molecular weight and 3)     probiotic bacteria that contribute to the development of the newborn immune system.      Probiotics have a potent immunogenic activity as well as an immunoprotective potential in     maternal milk after administration of probiotics during pregnancy and breastfeeding. In     addition probiotics are supposed to play a role in the increased production of     sphingomyelinase.   "
146445|NCT01367457|"     The principal objective of the study is to evaluate the efficacy and safety of temsirolimus     use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.   "
146446|NCT01367444|"     Primary Objective:      To assess the safety and tolerability of ascending doses of SAR422459 in patients with     Stargardt's Macular Degeneration.      Secondary Objective:      To evaluate for possible biological activity of SAR422459.   "
146447|NCT01367431|"     The purpose of this study is to determine the pharmacokinetics (PK) of xanthohumol (XN).     Small amounts of xanthohumol occur naturally in hops, used to make beer, and XN is also found     in beer itself. Studies in animals have shown that XN can lower blood sugar and blood lipids     such as triglycerides, which can contribute to heart disease. The purpose of this study is to     see how much of the XN is absorbed into the blood and how fast it leaves the body when taken     by mouth. Once the PK study has been done, the investigators' long-term goal is to learn if     xanthohumol can lower risk factors for heart disease and type-2 diabetes in humans.   "
146448|NCT01367418|"     Several recently published retrospective studies show that regional anaesthesia (RA) can     reduce cancer-related mortality following surgical treatment of colorectal, breast and     prostate cancers and malignant melanoma. If these results are true, then the choice of     perioperative pain management is as beneficial, or even better, than the current oncological     therapies. This theory needs to be investigated in a prospective, randomized and controlled     trail. We shall perform a prospective, randomized study comparing the effects of Thoracic     epidural analgesia (TEA) or patient controlled analgesia (PCA) on postoperative immunological     and inflammatory markers in order to understand whether the protective effects, if any, of     regional analgesia are due to changes in these markers or whether the underlying mechanisms     is not mediated via this stress signalling pathway.   "
146449|NCT01367405|"     Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical     entity. The most characteristic feature is the disproportionate more motor impairment of the     arms and especially the hands than the legs, bladder dysfunction and sensory.      Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal     cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord     lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact     incidence is not known.      Uncertainty about the treatment exists. A good recovery has been described after conservative     treatment. Conservative treatment was usually considered when a fracture or dislocation of     the spine were absent. It is often seen in hyperextension trauma in the elderly with     degenerative spondylotic stenotic cervical spine. However, some reports suggest a better     outcome after surgical decompression. Randomized trials have not been performed. To avoid     discussion about possible confounding or effect modification related to the mechanism of     trauma, this study will focus on ICSCL in patients without fracture or instability of the     cervical spine on radiological examination. Also the problem of crossover from the     conservative group to the surgical one due to the nature of spinal instability will be     reduced.      Goal of the study: To compare the efficacy of early decompressive surgery to improve     functional outcome in patients with ICSCL without a fracture or instability of the cervical     spine compared to those receiving conservative treatment.      Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a     cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that     could indicate a fracture of the cervical spine or instability. An overt sequestrated     herniated disc should not be present since this will always necessitate immediate surgery.     Involvement of the cervical spinal cord should be established at physical examination     (symptomatic arm or hand dysfunction is obligatory).   "
146450|NCT01367392|"     The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle     Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations .     The device used in this study is designed to assist the physician in guiding the needle     towards the suspected area. This device does not change the procedure of liver biopsy or     ablation. The only difference is that a small adhesive pad is placed on the skin and a     miniature video camera is attached to the end of the needle. This camera does not enter the     body.   "
146451|NCT01367379|"     The investigators will study in the possibility of cardiovascular disease, caused by the duty     loading, of physician of internal medicine. The investigators will also explore if there     {dose response effect} between the duty loading and the stress response of physicians of     internal medicine. Therefore, the investigators will compare the stress responses of     physicians of internal medicine during with different duty loading ( non-duty day, one duty     area with 3 wards, 2 duty areas with 6 wards) in a observational method. Those stress     response will be measured by cardiovascular risk indicators, including blood pressure, heart     rate variability, blood sampling and urine sampling.   "
146452|NCT01367366|"     Lung cancer is the leading cause of death in Taiwan. The outcomes of the disease vary     depending on early detection, histologic types and staging. Because the mediastinal     involvement including lymph node status is a significant prognostic factor for survival,     lymph node biopsy is necessary for clinical staging of some patients. Although     fluorodeoxyglucose-positron emission tomography (FDG-PET) is suggested for precise evaluation     of mediastinum, tissue proof of PET positive lesions are recommended due to its limited     diagnostic specificity for identifying mediastinal metastases. Cervical mediastinoscopy     remains the gold standard for mediastinal lymph node sampling. However, it is invasive,     requires general anesthesia. Another new minimally invasive method of mediastinal biopsy is     real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The     aim of this study is to compare the accuracy of PET and EBUS-TBNA for correct staging of the     mediastinum for lung cancer patients.   "
146466|NCT01367184|"     Inferior vena cava (IVC) filter is an important therapeutic device used in the management of     venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation     therapy. While there has been significant increase in the use of filters , unfortunately     there are no standardized collection of data to track, compare outcomes, report safety and     efficacy.   "
146468|NCT01367145|"     The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy     on surrogate markers of disease severity and/or prognosis in patients with PAD.      Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.      Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation     using brachial artery ultrasound.      Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse     wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.   "
146453|NCT01367353|"     Specific aims: Identification and characterization of cancer stem cell-like population     (cancer stem cells or cancer initiating cells) from primary tumor tissue, primary ascites and     peripheral blood of ovarian cancer patients and genetically engineered mouse ovarian cancer     cell lines.      Objectives: In the future, individualized therapy must incorporate analysis of the cancer     stem cells or cancer initiating cells of ovarian cancer cells when designing therapeutic     strategies for ovarian cancer patients.      Aims of this project:        1. Isolation and identification of cancer stem cell-like population (cancer stem cells or          cancer initiating cells) from primary tumor tissue, primary ascites and peripheral blood          of ovarian cancer patients        2. In vivo tumorigenicity assay will be performed to measure tumor formation from these          cancer stem cell-like population when equal numbers were injected into the dorsal fat          pad of nude mice.        3. To establish a standard protocol of stem cell-like population maintenance        4. Screening of potential specific biomarkers involved in these ovarian cancer stem          cell-like population.   "
146454|NCT01367340|"     The purpose of this study is to investigate the effects of a 6-month physical activity     intervention program on mobility and participation after the termination of a 6-week     functional strengthening program for school-age children with spastic diplegia cerebral     palsy. The primary outcomes are gross motor function, participation, and physical activity     behavior.   "
146455|NCT01367327|"     The purpose of study is to investigate the effects of PSE Music with a home-based loaded     STS exercise program on the functional strength, gross motor function, daily participation,     exercise involvement, motor control, and gait speed for children with spastic diplegia.   "
146456|NCT01367314|"     This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5%     NVC-422 topical gel in children with impetigo.   "
146457|NCT01367301|"     This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating     patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells.     Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to     stop the growth of tumor cells, either by killing the cells or stopping them from dividing.     Giving radiation with chemotherapy may kill more tumor cells.   "
146458|NCT01367288|"     Breast cancer is the leading female cancer by a very wide margin in France. Despite     widespread breast cancer screening, many cases of breast cancer are discovered at a locally     advanced stage. The tumoral consequences of a cancer size greater than 3 cm are: increased     risk of metastasis and death and, most often, impossibility of performing breast-conserving     surgery (a mastectomy is usually advisable in case of a first surgical procedure). It is     increasingly recommended to treat locally advanced breast cancers with neoadjuvant     chemotherapy. Very numerous studies have shown that by proceeding that way, the oncologic     prognosis was not harmed and, on the contrary, it was possible to obtain sufficient tumor     response to allow breast-conserving treatment in more than 60% of cases.      The use of zoledronic acid (Zometa) has an established place in the management of     malignancies with a predilection for skeletal involvement (in particular metastasis).     Although the main target of biphosphonates is the osteoclast, there is also preclinical data     indicating that biphosphonates can have effects on cells other than osteoclasts, including     tumor cells. Anti-tumor activity including inhibition of tumor cell growth and induction of     tumor cell apoptosis, inhibition of tumor cell adhesion and invasion, and anti-angiogenic     effects have been demonstrated. In addition several in vitro studies have shown that Zometa     causes synergistic induction of breast cancer cell apoptosis when combined with clinically     relevant concentrations of chemotherapy drugs such as paclitaxel and doxorubicin. Therefore     testing of combinations of biphosphonates with these agents in breast cancer is of     significant interest.      In the context of locally advanced breast cancers, the combination of a bisphosphonate with     neoadjuvant chemotherapy appears to have an important potential: preventing possible bone     metastases, but also possibly amplifying the efficacy of the chemotherapy's tumoricidal     activity, both on the primary tumor and on potential metastatic localizations.      So it appears that, the use of bisphosphonates in a neoadjuvant situation presents a     potentially favorable benefit-risk ratio. That is why we are proposing to perform a     prospective randomized multicenter comparative study to evaluate 2 systemic neoadjuvant     treatments, one with Zometa and the other without Zometa, in patients with locally advanced     breast cancer. Zometa will be administered according to the usual administration procedure:     one infusion every 3 weeks.      The therapeutic response will be evaluated by studying the different biological markers     (circulating blood and bone marrow tumor cells, serum cell apoptosis and neoangiogenesis     markers, bone resorption markers, etc.), but also by analyzing clinical, radiologic, and     histologic response and by breast conservation rates. The impact of other factors that may     affect therapeutic response will be taken into account: aggressivity of the tumor, presence     or absence of tumor receptors, tumor stage, etc.      The purpose of the study is to show a marked benefit of treatment with Zometa in managing     locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy and     improvement in the laboratory parameters of tumor aggressivity. These markers will be used as     surrogate markers of long term outcome.   "
146459|NCT01367275|"     The goal of this clinical research study is to learn if adding brivanib to irinotecan can     help control the disease in patients with colorectal cancer that has spread. The safety of     this drug combination will also be studied.   "
146460|NCT01367262|"     An open-label study being conducted to determine the metabolism and physiological disposition     of radiolabeled LY2886721 after a single dose in healthy male subjects.   "
146461|NCT01367249|"     This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.   "
146462|NCT01367236|"     The purpose of this study is to compare two different combination anti-HIV therapies over 48     weeks and to assess if differences in improvement in the function of the brain are observed     over this period.      The study will compare anti-HIV therapy combinations which are currently in use.      The patients will not have had any previous treatment for their HIV infection.   "
146463|NCT01367223|"     This study aims to describe the use of glutamine supplementation in the modulation of     inflammatory response in critically ill pediatric patients and to determine if this decrease     leads to clinical improvement in morbidity and mortality in these patients. Thus, these     patients' diet could be supplemented with glutamine in order to improve their evolution.      Hypothesis:      From the data obtained in the study of the literature the investigators consider that:      Critically ill patients have a deficit of glutamine either because of an increase in its     consumption or a decrease in its availability, and therefore blood glutamine levels are low.      Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).      In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The     administration of glutamine supplements to these patients decreases oxidative stress due to     the increase in HSP-70.      Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.      The administration of glutamine supplements in these patients increase IL-10 levels.      Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.   "
146464|NCT01367210|"     Objectives of the study:        1. To verify the safety and the efficacy of the study treatment, defined as the persistent          control of the virus' replication at 48 weeks after the simplification to maraviroc +          darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.        2. To collect relevant information about the safety, the immunologic and the economic          impact of this strategy.   "
146465|NCT01367197|"     PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic     heart failure, while little is known about the effect in atrial fibrillation (AF). The     investigators studied the effect of physical exercise on cardiac output (CO), max. exercise     capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of     physical exercise training three times weekly for twelve weeks.      HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers     and quality of life (Qol) in patients with AF.      METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and     muscular strength was performed before and after 12 weeks.      Resting echocardiography was done at baseline. CO was measured using impedance cardiography     at rest and during maximal exercise testing on an ergometer bicycle. Body composition,     muscular strength and six minutes walking capacity were measured before and after the     training period. Qol was evaluated by the use of the standardized validated questionnaires     Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).      Training consisted of aerobic exercise at 70 percent of max. capacity estimated by     Borg-scale.   "
146469|NCT01367132|"     The primary objective of this study is to determine the detection rate of two- or     three-vessel umbilical cord at the time of nuchal translucency screening between 11 and 13     6/7 weeks gestation.      Hypothesis: Detection rate of the number of vessels during first trimester will be as     accurate as the detection of vessels during the second trimester.   "
146470|NCT01367119|"     Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT)     accelerate the antidepressant effect of ECT?      The study hypothesis was that depressed subjects receiving ECT with ketamine as the     anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression     ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic     agent.   "
146471|NCT01367106|"     The main objective of this study is to show that the fetal exposure to excess of     glucocorticoids is associated with a deficiency of the function beta insulin in the offspring     adult.   "
146472|NCT01367093|"     The purpose of this study is to identify within a cohort of ICU patients admitted for severe     illness those who are at risk of death in the year following the discharge from ICU.   "
146473|NCT01367080|"     To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride     film-coated tablet 10mg & 25mg   "
146474|NCT01367067|"     The objective of the study is to search for possible predictors for claustrophobia during     magnetic resonance (MR) imaging. A claustrophobic event shall be defined by an incomplete     examination, or a complete examination that requires coping actions by the staff. Coping     actions may consist of the administration of sedatives, prism glasses, an MR imaging test run     with the patient, a pause, the prone position, an escort in the scanner room, and supportive     communication. The investigators hypothesize that there is a difference between patients with     and without events in their scores on the Claustrophobia Questionnaire and several further     psychometric questions. Other factors may also favour events like patient characteristics,     examined region, duration of the examination and scanner type. Therefore, predictors could     identify patients who are likely to experience claustrophobia during MR imaging so that they     can receive the appropriate support by the staff to complete their examination. Thus a larger     patient population could benefit from MR imaging.   "
146475|NCT01367054|"     The objective is evaluate, in healthy volunteers, the bioavailability of two products     containing metformine 500 mg to determine if they are bioequivalent and identify the     occurrence of adverse events.   "
146476|NCT01367041|"     The aim of this study is to investigate effects of femur exposed to vibration on the rest     muscle electrical activity of hip adductors in cases with postmenopausal osteoporosis.      Among patients who will be admitted to the investigators clinic for out-patients and whose     bone densitometric measurement will be made with a prediagnosis postmenopausal osteoporosis,     a total of 80 voluntaries [40 having postmenopausal osteoporosis (femur neck or total hip T     score < -2.0) and 40 Controls (Hip and lumbar bone mineral density normal)] are planned to     include in this study.      After the left hip bone mineral density (BMD) and BMC is measured in all cases, whole body     vibration will be applied in PMO groups and Controls. The rest muscle electrical activity of     left hip muscles will be evaluated at pre-treatment, post-treatment and, during treatment in     patients with PMO and then their data will be compared with Controls data.      Plasma sclerostin level will be measured before and 10th minute after vibration.      Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and     amplitude of 2 mm for 30 + 30 seconds. WBV will be applied one session only. The left hip BMD     and BMC will be evaluated by bone densitometer (Norland).      The rest muscle electrical activity of hip adductor muscles at rest will be measured by     PowerLab (data acquisition system, ADInstruments, Australia) device.      This project is planed to be completed in 3 months.   "
146477|NCT01367028|"     Multicenter randomised phase II study of neoadjuvant therapy in HER2 positive early breast     cancer. Primary aim is to evaluate the cardiac toxicity of the combined treatment     (trastuzumab, docetaxel, bevacizumab, NPLD) in comparison to the standard therapy.   "
146478|NCT01367015|"     The purpose of the study is to compare early versus late initiation of enteral feeding in     premature growth restricted babies below the gestational age of 35 weeks born to mothers with     prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the blood     flow from the mother to the baby brings all the nutrients required for growth and the very     vital oxygen required for survival. These deprived babies with poor blood flow adapt to the     not so conducive uterine environment by certain adjustments in blood supply to internal     organs. This permits the best possible blood flow to brain heart etc., which are the vital     organs and whose adequate functioning is required for survival. As a consequence, the gut     (intestines) gets poor blood supply and hence its appropriate functioning may be jeopardized.     Such 'premature growth restricted' babies are at increased risk of further growth faltering     if not fed adequately as also to a condition called 'Necrotising enterocolitis' if fed     liberally like other healthy neonates, characterized by abdominal distension, blood in stools     and inability to feed for longer durations thereby further affecting growth. In the past such     babies (after birth) were not fed for days together which compromised their growth even     further. It is not clear whether continuing to withhold feeds for prolonged duration will     prevent NEC but lead to growth faltering and initiating feeds early will potentiate NEC with     further compromised growth and increased morbidity. There are no randomized trials on feeding     strategies in this group of neonates and hence the investigators planned to carry out this     study on comparison of early versus delayed initiation of feeding in preterm SGA infants with     AREDF.   "
146479|NCT01367002|"     The primary objective of this study is to estimate whether the addition of trastuzumab to     paclitaxel and carboplatin chemotherapy improves progression free survival when compared to     paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients     overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence     in situ hybridization (FISH).   "
146480|NCT01366989|"     The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle     Arthroplasty in patients having a calcaneal stem.   "
146524|NCT01366404|"     About 10,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for     the natural history of coronary lesions at 2 year clinical and imaging follow-up.   "
146481|NCT01366976|"     Acute kidney injury is a major complication of cardiac surgery requiring cardiopulmonary     bypass (CPB). Hemolysis and rhabdomyolysis frequently occur during CPB. Hemolysis leads to an     increase in free hemoglobin, whereas rhabdomyolysis leads to an increase in myoglobin. Free     plasma hemoglobin and myoglobin have been shown to be independent predictors of the acute     kidney injury that results from CPB. When these hemeproteins are released into the plasma,     they undergo redox cycling, generating radical species that initiate lipid peroxidation and a     cascade of oxidative damage to cellular membranes, notably in the kidney. F2-isoprostanes and     isofurans are sensitive and specific markers of oxidative stress in vivo, and are increased     after CPB, particularly in those patients with acute kidney injury. Acetaminophen inhibits     the lipid peroxidation catalyzed by myoglobin and hemoglobin. Moreover, in an animal model of     rhabdomyolysis-induced kidney injury, acetaminophen significantly attenuated the decrease in     creatinine clearance compared to control. The current proposal tests the central hypothesis     that acetaminophen will attenuate the lipid peroxidation associated with the hemolysis and     rhabdomyolysis that occur in patients undergoing CPB. Demonstration that acetaminophen     inhibits the lipid peroxidation resulting from CPB would provide a rationale for a     prospective randomized trial to test the hypothesis that acetaminophen will reduce the acute     kidney injury that results from CPB.   "
146482|NCT01366963|"     A common complaint among people with Postural Tachycardia Syndrome (POTS) is brain fog or     difficulty concentrating. This is very poorly understood. To better understand this cognitive     dysfunction, the investigators will test people with POTS and people without POTS using     various neuropsychiatric instruments. The investigators hypothesis is that people with POTS     will have greater abnormalities on neuropsychiatric testing than normal controls.   "
146483|NCT01366950|"     The purpose of this study is to determine if intelligent physical exercise training can     increase the productivity of office workers in Denmark. Effects of intervention is measured     after 1 and 2 years.      The project is driven as a change project.      The investigators measure productivity as:        -  Individual health        -  Sick leave        -  Retention at the workplace   "
146484|NCT01366937|"     The hypothesis of this study is that chicken eggs can be enriched in vivo with 14C-B12 and     fed to healthy human subjects to determine B12 bioavailability from eggs.      The goal of this research is to enrich eggs in vivo with radioactively labeled vitamin B12 to     a level that allows us to feed the enriched eggs to humans and determine how much of the     vitamin B12 is digested and absorbed into the body. This will tell us if eggs are a good     dietary source of vitamin B12. Importantly, sensitive technology available at the Lawrence     Livermore National Laboratories allows us to measure very low amounts of radioactive vitamin     B12. This allows us to do this experiment with a level of radioactive B12 that is not harmful     to animals or humans. The results of the investigators first experiment indicate that the     investigators can inject radioactively labeled vitamin B12 into a laying hen and detect the     radioactive vitamin B12 in the eggs at a level sufficient for feeding to humans in a     bioavailability study.   "
146485|NCT01366924|"     The modern warfighter faces numerous physiological challenges including sleep deprivation,     sustained intense physical activity, and caloric restriction, the combined effects of which     may result in the loss of lean body mass and decreased physical performance. Dietary     interventions may help preserve lean body mass and facilitate recovery from periods of     intense physical demand. For example, dietary strategies that increase amino acid     availability have been shown to stimulate protein synthesis in skeletal muscle following     resistance exercise. Because military tasks also incorporate endurance exercise components,     studies regarding the effects of increasing dietary amino acids following endurance exercise     are warranted. The objectives of this study are to characterize the effect of endurance     exercise on protein synthesis and breakdown as well as the ability of an essential amino acid     supplement to influence skeletal muscle protein metabolism and its cellular and molecular     regulation following endurance exercise.   "
146486|NCT01366911|"     This is a pilot study to provide preliminary data of the association between bone mineral     denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT),     at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays,     obtained at time of surgery, and to begin to evaluate if stem cells can predict orthopaedic     surgical outcomes.   "
146487|NCT01366898|"     The protocol objective is providing adequate treatment and based on broad consensus in     elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that     enables a joint analysis of results strong enough to make conclusions on specific subgroups     of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of     age or associated diseases). Provide results of a treatment to consider standard against     which to compare the results of phase II trials of experimental drugs that undoubtedly will     be activated in the coming years   "
146488|NCT01366885|"     The purpose of this study is to determine whether by administering vitamin D to mothers who     already have at least one child with autism and who are pregnant, that the vitamin D will     prevent the recurrence of autism in the newborn sibling.   "
146489|NCT01366872|"     This is a research study which is being done to determine the outcomes following Agility LP     ankle replacement. This implant was approved by the FDA in 2007 and has been used since then     with good early results. You are being asked to volunteer for this study because you have     undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to     compare the range of motion, level of pain and function during daily living prior to and     after your ankle surgery.   "
146490|NCT01366859|"     This study will evaluate the effects of a cysteine-rich whey protein isolate supplement     (Immunocal®) on autistic behavior in pre-school children with autism.   "
146491|NCT01366846|"     ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).      Peanut Allergy, a recognized public health concern, is a common and potentially     life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study     evaluated whether early exposure to peanut promotes tolerance and provides protection from     developing peanut allergy in children who are allergic to eggs or who have severe eczema.     ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect     of twelve months of cessation of peanut consumption in LEAP Study participants who consumed     peanut and those who avoided peanut over the previous five years.   "
146492|NCT01366833|"     According to the Canadian Cancer Society there are approximately 1700 new cases of esophageal     cancer per year in Canada. As most of these patients are diagnosed in advanced stages of the     disease, 1800 deaths are estimated from this cancer annually . Progressive dysphagia is the     most common presenting symptom and impacts not only the patient's quality of life but the     ability to tolerate life prolonging treatments such as systemic chemotherapy.      Although there are several therapeutic modalities to alleviate malignant dysphagia including     laser, photodynamic therapy and cryotherapy , the use of stents and radiotherapy are the most     commonly employed. However, the optimal approach to effective, timely treatment of malignant     dysphagia remains a challenge. The investigators conducted a preliminary retrospective review     to investigate such palliation procedures and found that a multi-modality approach may yield     the most favourable results .      Therefore, our clinical trial will examine the effectiveness of adding a single dose of     brachytherapy to patients with severe dysphagia who have already been treated with a     endoscopically placed self-expanding metallic stent.   "
146493|NCT01366820|"     The purpose of this study is to determine whether NNZ-2566 is safe and effective in the     treatment of Traumatic Brain Injury (TBI).   "
146494|NCT01366807|"     Screening of nutritional status is unsolved problem in cardiac surgery. Applicability of such     criteria as body mass index and albumin and screening scales (MNA, NRS-2002, SGA, SNAQ) in     cardiac surgery is controversial and insufficiently studied. Furthermore, there is some known     predictors of poor outcome, which closely related to nutritional status (C-reactive protein,     total lymphocyte count). The aim of this study is assessment of several nutritional screening     scales, objective nutritional criteria and predictors for the purpose of detection of most     informative one or its combination.   "
146495|NCT01366794|"     Study hypothesis is to examine the relative contribution of macronutrients for gut hormone     secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes.     Individual macronutrients or a mixed meal will therefore be served and gut hormones are     measured during the following 300 min.   "
146496|NCT01366781|"     The study hypothesis is that the release of gut hormones is increased proportionally to     caloric load in each meal. Three different meals with different meal size will therefore be     served and gut hormones determined.   "
146497|NCT01366768|"     The study hypothesis is that gut hormones are released after oral but not intravenous amino     acids which result in stimulation of insulin secretion.   "
146498|NCT01366742|"     The natural history of human papillomavirus (HPV) is most likely influenced by both innate     and adaptive mucosal immunity. More specifically, we hypothesize that Toll like receptors     (TLR) play an important role in cervical innate immunity to HPV through secretions of     proinflammatory, chemotactic and anti-viral cytokines. Up-regulated TLR expression will also     result in activation of dendritic cells and T cells that in turn will promote a T helper (Th)     l like response through secretion of several cytokines and consequently, the induction of a     successful cell mediated immune (CMI) response.   "
146499|NCT01366729|"     Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30%     remain unable to walk and up to 60% are left with moderate to severe walking disability.      Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side     influence ipsilesional cortical plasticity and improve functional outcomes. Canes are     commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle     activity. We have shown that an orthosis TheraTogs ( elastic corset supporting hemiplegic     side) significantly increases hemiplegic muscle activity during gait.      To date no clinical studies have investigated the long term effects of these techniques on     gait recovery following stroke.      This study aims to determine if advances in the understanding of cortical plasticity and its     relation to functional recovery following stroke can be applied to clinical gait     rehabilitation to improve long term outcomes.      Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and     inhibit balance reactions. In the long term this causes poorer walking ability and balance     and consequently reduced social participation.      Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and     facilitate balance reactions. In the long term this improves walking ability and balance     leading to increased social independence and participation.      Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke     patients Intervention When subjects can walk unaided on even ground whilst requiring verbal     prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into     intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip     extensor and abductor musculature according to a standardized procedure. Cane walking with     cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the     day with the assigned walking aid. Standard therapy treatments and usual care will remain     unchanged and documented.The intervention will continue for five weeks or until patients have     reached FAC 5 (independent walkers on all surfaces).      Measures: the day before intervention begin, the day after intervention completion (max 5     weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed up and go     test Secondary outcomes surface EMG of hemiplegic lower extremity musculature,     temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale.      Results Significance levels will be 5% with 95% CI`s. ITT analyses will be performed.     Descriptive statistics will be presented. Relevant co-variables will be identified and     analysed. Discussion This study could have significant implications for the clinical practice     of gait rehabilitation after stroke in particular the effect and appropriate use of walking     aids   "
146500|NCT01366716|"     Contingency management (CM) is a demonstrably efficacious intervention for substance abuse     and dependence. Although CM protocols have employed a variety of reinforcers, they have     almost exclusively relied upon non-cash privileges (e.g., take-home methadone doses), prizes,     or vouchers that can be exchanged for goods or services. Despite the strong empirical support     for CM, our research suggests that concerns relating to its cost and safety (e.g., potential     for harm caused by rewards undermining intrinsic motivation or being sold to purchase drugs)     have hindered its transfer to real-world practice. The exclusive use of non-cash CM likely     stems from the untested assumption that clients will use cash incentives to buy drugs or     engage in other high-risk behaviors. This assumption is problematic for two reasons. First,     the use of non-cash incentives may add substantial costs and complexity to CM protocols.     Second, the use of non-cash incentives may reduce the efficacy of CM interventions, as     research suggests that cash may be a more effective reinforcer than vouchers. This study     examines both practical and ethical issues relating to cash-based CM procedures. This study     consists of three phases; a main experiment, a Cash Bowl pilot, and a Thinning Pilot.   "
146525|NCT01366391|"     Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2     Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome,     gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary     syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation.     In every day medical practice lower doses of Metformin are administered searching for the     continuation of the treatment.      However, there is no clinical study to support this assertion. The objective of this study is     to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking     daily doses of 1500mg and 1000mg.   "
146501|NCT01366703|"     Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission     for heart failure. New methods have been developed to continuously monitor arrhythmia's and     heart failure parameters. One such method is implantation of an implantable loop recorder.     Also home-monitoring is available for continuous monitoring and information sending to the     treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever     arrhythmia's we hope to improve patient care.      Objective of the study:      To investigate the clinical efficacy in detecting clinically relevant arrhythmia's     (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated     risk factor for stroke and transient ischemic attack (TIA)(CHADS-score >2), currently not     treated with oral anticoagulation (OAC).      Study design:      In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class)     2-3, a CHADS2-score>2 and no indication for a implantable cardioverter-defibrillator (ICD) or     pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward     clinic visits. The number of relevant arrhythmia's detected will count for the primary     endpoint. Also the number of medication changes and institution of OAC.      Study population:      50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT     implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.      Primary study parameters/outcome of the study:      Primary endpoints        -  AF burden and AF episodes detected        -  Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias          (VT's) or bradycardias        -  % patients on OAC after 1 year follow-up        -  Number of clinically relevant patient activated events        -  Number of treatment policy changes based on the Reveal XT      Secondary study parameters/outcome of the study        -  specificity of AF detection algorithm by the Reveal        -  Predictive value of the cardiac Compass data to predict worsening heart failure          episodes.   "
146502|NCT01366690|"     The provision of HIV care and prevention services in resource-limited settings (RLS) entails     substantial challenges due to a human resource crisis.[1] One strategy to address this human     resource crisis is task shifting—the redistribution of tasks from higher trained providers to     health workers with less training. Peer supporters, a group of community health workers who     are people living with HIV (PLHIV), are an underutilized cadre to whom tasks can be shifted.     Peers have been used extensively and effectively in HIV/AIDS programs in RLS, typically as     peer educators who provide HIV prevention and education services.[2] Peers may be a potential     source for not only providing care, but also impacting patient behaviors through peer     counseling, education, and psychosocial support.      With the scale up of HIV counseling and testing in RLS, increasing numbers of PLHIV know     their serostatus and could potentially be engaged in care and prevention services. While     antiretroviral therapy (ART) is a critical component of care which has been a source of much     attention, PLHIV who are not yet on ART can also benefit from being engaged in care and     utilizing other evidence-based health interventions besides ART. Also, many HIV/AIDS care     programs have difficulty both retaining PLHIV in care prior to ART and initiating ART in a     timely fashion. Additionally, many PLHIV not yet on ART still engage in risky sexual     behaviors and do not fully utilize a proven basic preventive care package (BCP) set of     interventions (cotrimoxazole prophylaxis, bed nets, and safe water systems). Peers may be     able to impact PLHIV not yet on ART by improving linkages to care, facilitating timely     initiation of preventive interventions and ART, and decreasing risky sexual behaviors.     However, well-designed and evaluated operations research is needed to assess peer support     effects on these care and behavioral outcomes.      The objective of this study is to assess the impact of a peer support home visit intervention     on patient engagement in care, utilization of a basic care package (BCP) of preventive care     interventions, and risky sexual behaviors among people living with HIV (PLHIV) not on     antiretroviral therapy (ART) through an individually randomized, operations research,     community-based trial. We will compare outcomes between PLHIV who receive the peer-led     intervention to those who do not. The primary outcomes will be engagement in care, BCP     adherence, and condom use. The study hypotheses are as follows: (1) PLHIV who receive the     peer intervention will have improved engagement in care compared to PLHIV not receiving the     intervention; (2) PLHIV who receive the peer intervention are more likely to adhere to a BCP     of interventions to prevent illness compared to PLHIV not receiving the intervention; (3)     PLHIV who receive the peer intervention will have less risky sexual behaviors compared to     PLHIV not receiving the intervention.   "
146503|NCT01366677|"     This study aims to provide novel information on the feasibility of yoga interventions for     secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood     states, fall risk and balance. This information will be important for determining safe,     cost-effective and reliable practices for the benefits of yoga as an alternative means for     improved health and well-being. A yoga intervention that is integrative and evidence-based     will benefit the blind population through effective treatments and prevention of secondary     symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in     the future.   "
146504|NCT01366664|"     The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug     has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60     mg when concomitantly administered in participants taking terazosin.   "
146505|NCT01366651|"     The purpose of this study is to characterize the penetration of doripenem in the cerebral     spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented     or suspected infection and are planning to, or undergoing treatment with intravenous (IV)     antibiotics.   "
146506|NCT01366638|"     The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination     with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus     (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser     or non-responder to Interferon-based therapy) in Japan.   "
146507|NCT01366625|"     The purpose of this study is to investigate the clinical utility of renal denervation for the     treatment of resistant hypertension coexisting with obstructive sleep apnea.   "
146508|NCT01366612|"     This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan     and low dose total body irradiation in patients undergoing allogeneic stem cell     transplantation. A study population of 80 subjects will be enrolled from The John Theurer     Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive     allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will     be consented and enrolled. Subjects will be randomly assigned to receive one of 2     conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total     body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess     the relapse rate in each arm and transplant-related toxicity.      The combination of fludarabine and busulfan is the current standard of care for patients with     myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing     allogeneic transplantation at HUMC. In this study we will be comparing in a randomized     fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.   "
146509|NCT01366599|"     Describe cardiovascular events in a cancer population receiving highly emetogenic     chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).   "
146510|NCT01366586|"     The study aims to:        1. Achieve molecular imaging of MG7 antigen in patients with gastric cancer in vivo using          confocal laser endomicroscopy.        2. Compare the results of in vivo MG7-specific molecular imaging with CLE and ex vivo          immunohistochemistry .   "
146511|NCT01366573|"     The aim of the study is to assess the safety and tolerability of GSK1521498 in combination     with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you     have been given these together. The study will also determine whether GSK1521498 will have an     effect on alcohol liking and consumption.   "
146526|NCT01366378|"     This open-label study assesses the single-dose pharmacokinetics of intravenously-administered     MNTX in healthy adult male and female subjects in the absence of, and in the presence of,     orally-administered cimetidine.   "
147707|NCT01350869|"     The objective of this study is to evaluate effectiveness and safety of everolimus-eluting     stents (XIENCE, Abbott) in the real world daily practice as compared with first-generation     drug-eluting stents (sirolimus-eluting stents).   "
146512|NCT01366560|"     GSK962040 is a selective non-peptide motilin receptor agonist which is in development for the     treatment of conditions associated with slow rates of gastric emptying. Single ascending     doses (1 to 150 mg), and 14-days repeated doses (10 to 125 mg daily) have been investigated     in two randomized, placebo-controlled trials. Results show that these doses were well     tolerated with few mild to moderate adverse events (AE), and no clinically significant     abnormal vital sign measurements, ECG changes or abnormal clinical laboratory findings.     GSK962040 exhibited predictable PK with and without food. The mean within subject time for     half a [13C]-containing meal to empty from the stomach (GE t½) decreased by 22-43% from     placebo with GSK962040 50-150 mg single doses, and shortening of gastric emptying was     confirmed at doses of 50 mg and above in the repeat dose study.      Several studies have shown that motilin agonists increase lower oesophageal sphincter (LOS)     pressure and have various dose dependent effects on oesophageal peristaltic amplitudes and     propulsive contractions in both healthy volunteers and patients with gastro-oesophageal     reflux disease (GORD). The purpose of the present study is to examine the effect of GSK962040     on oesophageal function, using techniques such as high resolution oesophageal manometry, and     pH/gastric transit using a wireless motility capsule.   "
146513|NCT01366547|"     Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in     phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations     (FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of     tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first line     regimen due in large part to its convenient presentation as a full treatment regimen in a     single product, other options are needed. A fixed-dose combination of DTG/abacavir     (ABC)/lamivudine (3TC) is one such opportunity.      This is a single-center, randomized, open-label, 3-period crossover study in healthy adult     subjects to evaluate the single-dose relative bioavailability of two experimental oral DTG 50     mg/ABC 600 mg/3TC 300 mg FDC tablet formulations compared to co-administration of the     separate tablet formulations (DTG 50 mg tablet and EPZICOM), with each dose administered in     the fasted state. Approximately 18 subjects will be enrolled and randomized to one of 6     different treatment sequences. There will be a screening visit within 30 days prior to the     first dose of study drug and a follow up visit within 7-14 days after the last dose. There     will be a 7 day washout between doses in each treatment period.      The following PK parameters for DTG, ABC and 3TC will be measured: area under the     concentration curve from time zero (pre-dose) extrapolated to infinite time     (AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the     time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration     (Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax     (tmax), terminal phase half-life (t½), apparent clearance following oral dosing (CL/F) and     apparent terminal phase volume of distribution (Vz/F).   "
146514|NCT01366534|"     This study will evaluate whether administration of two investigational malaria vaccines     (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection     against malaria infection as compared to protection induced by the 257049 vaccine alone. The     study will also evaluate the safety and the immune response to the new combination of the two     experimental malaria vaccines.   "
146515|NCT01366521|"     A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients     with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of     mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety,     pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as     safety/tolerability assessments will be collected throughout the study   "
146516|NCT01366508|"     GSK is planning to undertake two anti-obesity drug studies in the area of obesity. In     addition to assessment by questionnaires, it would be of significant value to incorporate an     objective non-interventional measure of cognitive or motivational processing associated with     evaluating and responding to food stimuli. Obesity is associated with increased attentional     bias to palatable foods. The aims of this protocol are two-fold, first to characterize Event     Related Potentials (ERPs) of two common aspects of food stimuli relevant to eating disorders     -presence of food and its palatability, and secondly, to assess the modulation of these ERPs     by appetite. Following a successful completion of this study, it is the intention to use the     paradigm developed in future studies in the area of obesity.   "
146517|NCT01366495|"     The investigators propose to conduct both a randomized trial of HIV testing in community     corrections, and a randomized trial of linkage to HIV care for people with HIV recruited     through community corrections (probation and parole).   "
146518|NCT01366482|"     The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the     use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment     with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone     in patients with peripheral arterial disease.   "
146519|NCT01366469|"     The primary objective of this pilot study is to identify and quantify inflammatory and     genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history     of chronic obstructive pulmonary disease (COPD) undergoing elective coronary     revascularization (CABG) to determine the risk of developing post operative respiratory     failure. To achieve this objective, this proposal outlines the following specific aims:      Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in     patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at     the time of intubation immediately prior to surgery and again upon skin closure immediately     after the surgical procedure.      Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with     post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24     hours), pneumonia, and/or tracheostomy.      Aim #3. To inform the development and implementation of a large pivotal trial which may     impact clinical decision-making during the initial pre-operative outpatient assessment of     COPD patients undergoing CABG.   "
146520|NCT01366456|"     The purpose of this study is to evaluate efficacy of Shingigu and Charcoal moxibustion     scientifically and objectively.   "
146521|NCT01366443|"     Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately     diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in     clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.   "
146522|NCT01366430|"     The purpose of this study was to compare the immediate efficacies of each treatment maneuvers     in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).   "
146523|NCT01366417|"     The primary objective of this study is to measure the antimicrobial effectiveness of     ChloraPrep One-Step Frepp Applicator.   "
146527|NCT01366365|"     This double-blind, randomized, two-cohort, placebo-controlled, parallel group study     characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses     and at steady-state during multiple dosing and assessed the effects of aging on the     pharmacokinetics, safety and tolerability of MNTX.   "
146528|NCT01366352|"     This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal,     healthy volunteers. Study treatment entailed single doses of two different formulations of     MNTX tablets.   "
146529|NCT01366339|"     This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy     volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of     each active treatment group is further randomized to a second, replicate dose of MNTX, and     the placebo group receives an additional placebo dose.   "
146530|NCT01366326|"     MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to     evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC)     injection for a period of seven days. Blood samples will be obtained at screening and for     drug concentration data.   "
146531|NCT01366313|"     The aim of our study is to define the median effective analgesic doses (ED50) of paracetamol,     morphine, and their combination and determination the nature of their interaction     administered IV for postoperative pain after moderate painful surgery using up-and-down and     isobolographic methods.   "
146532|NCT01366300|"     The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine     infusion initiated and maintained during surgery, on propofol requirements during general     anesthesia.   "
146533|NCT01366287|"     The primary purpose of this study is to estimate the relative bioavailability and food effect     of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical     studies.   "
146534|NCT01366274|"     This single-blinded randomized study aims to compare two methods of manual hyperinflation     (protective - moderate tidal volumes with positive end expiratory pressure) and     non-protective (large tidal volume and no positive end expiratory pressure) in ventilated     acute trauma patients, to investigate the effect on inflammatory markers, lung compliance,     oxygenation and sputum volume.   "
146535|NCT01366261|"     The purpose of our study was to compare the size and the quality of biopsy samples together     with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in     prospective, randomized fashion. The second aim was to compare safety and tolerability of     both types of procedure, performed in local anesthesia with addition of intravenous sedation     and analgesia.   "
146536|NCT01366248|"     This NIH-NCCAM funded epidemiologic research is being conducted as an observational     prospective case-control study of the use of Complementary and Alternative Medicine (CAM) and     Integrated Oncology (IO) and their effects on breast cancer patients in community settings.      Hypothesis: IO services improve patients' quality of life and decrease cancer recurrence     rates in breast cancer patients as compared to women with similar disease states and     prognoses who do not receive IO care, and may or may not use CAM treatment on their own.   "
146537|NCT01366235|"     Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic     differences of therapeutic effect of chloroquine and search the cause of these ethnic     differences. For this purpose, chloroquine will be administered to four ethic groups of     Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be     measured. The result of this study will be helpful in finding more adequate dosing regimen of     chloroquine in patients with malaria.   "
146538|NCT01366222|"     The purpose of this study is to determine whether food concentrates supplementation     (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma     symptoms and lung function in children due to asthma.   "
146539|NCT01366209|"     PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the     Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study     objectives are to confirm the treatment effect of pirfenidone compared with placebo on change     in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary     fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo     in patients with IPF.   "
146540|NCT01366196|"     Acute pain management is challenging in patients after spinal fusions, particularly since     most have taken analgesics for prolonged periods before choosing the surgical alternative.     Many of these patients are either preoperatively or become after surgery narcotic dependent.     In addition, the narcotic based anesthetic required for the procedure, may induce a     postoperative hyper-analgesia which may be partially responsible for the acute postoperative     pain which is refractory to traditional doses of narcotics. Both the persistent nociceptive     and neuropathic pain which these patients experience and narcotic-induced hyper-analgesia is     mediated via non-conventional neural pathways. It is for these reasons, that in these     patients postoperative pain is refractory to narcotic treatment. Postoperative pain in this     situation is best managed using a multimodal approach. This technique allows the application     of a number of treatment modalities which maximize pain reduction and minimize treatment side     effects.      Pregabalin (Lyrica) has been shown to be effective in the treatment of neuropathic pain.     Pregabalin has a similar mechanism of action as gabapentin. Notably it has a rapid consistent     absorption, linear pharmacokinetics, and a low potential for pharmacokinetic drug     interactions. Hence, pregabalin should be a beneficial addition to the multi-modal pain     regimen after spinal surgery; particularly in narcotic tolerant patients who respond poorly     to conventional narcotic analgesics after surgery.   "
146541|NCT01366183|"     This trial studies the chemotherapy toxicity on quality of life in older patients with stage     I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or     fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may     help doctors plan better ways to treat cancer.   "
146542|NCT01366170|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about biomarkers related to cancer. it may also help doctors     predict how patients will respond to treatment.      PURPOSE: This research trial studies biomarker expression in tissue samples from young     patients with anaplastic large cell lymphoma.   "
146543|NCT01366157|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors identify and learn more about changes that occur in DNA and identify biomarkers     related to cancer. It may also help doctors predict how patients will respond to treatment.      PURPOSE: This research trial is studying protein biomarker levels in tissue samples from     young patients with low-risk Hodgkin lymphoma.   "
146544|NCT01366144|"     This phase I trial studies the side effects and the best dose of veliparib when given     together with paclitaxel and carboplatin in treating patients with solid tumors that are     metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs     used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the     growth of tumor cells either by killing the cells, by stopping them from dividing, or by     stopping them from spreading. Giving veliparib together with paclitaxel and carboplatin may     kill more tumor cells.   "
146545|NCT01366131|"     This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed     to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin +     bevacizumab therapy in patients with histologically or cytologically documented inoperable,     locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.   "
146546|NCT01366118|"     The parameter that best correlates with 5 years disease-free survival (DFS ) in patients     (pts) with localized rectal cancer (RC) is the pathological TNM staging (ypTNM) after     chemo-radiotherapy (Ch-RT). DFS is 97% in pts with ypT0N0M0 = ypCR and 42% in pts with ypN +.     Standard 5-FU Ch-RT achieves 15% of ypCR. The use of IMRT achieves a high proportion of ypCR     . This study aimed to demonstrate in a prospective manner the feasibility of personalizing Ch     regimen base in TT in combination with IMRT in patients with RC. Secondary objectives     included the number of ypCR and safety.   "
146547|NCT01366105|"     In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid     in wound healing along the lines of closure for lower extremity amputation and complex     abdominal wounds. This study is designed to be a prospective, randomized clinical trial to     evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these     wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs.     standard dressing) prior to surgery, and will be followed in the post operative period to     monitor the effects on their surgical closures. The experimental group will consist of     participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device     placed intra-op along the line of closure. The control group will receive a standard surgical     dry sterile dressing. The surgical closures will be assessed after three days of treatment as     well as the first outpatient post-op visit and any subsequent visits through the following 6     months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult,     at risk surgical closures. Additionally, the investigators hope to show a difference in     clinical outcome of incisions treated by NPWT over our current standard technique.      All patients in the principal and co-investigators practice who are scheduled to undergo     lower extremity amputation or complex abdominal closure will be eligible for enrollment in     this prospective randomized study. There are no exclusion criteria. Informed consent will be     obtained pre-operatively. Data collection will include basic demographic data, disease     history, past medical and social history as well key data relating to wound healing     (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative     complications). The investigators will use simple statistical methods (ANOVA and chi-squared     analysis) to compare surgical wound healing between the two populations. The only deviation     from current standard of care in these populations includes utilizing a V.A.C. system on the     closure line of the experimental group versus the standard dry sterile dressing.   "
146548|NCT01366092|"     Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord     blood transplant. The donor's immune system may recognize the your body (the host) as foreign     and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought     that IL-2 may help control chronic GVHD by stopping the donor's immune system from     'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in     combination with steroids to treat cGVHD.   "
146549|NCT01366079|"     There was an only single operator study reporting dynamic position change during colonoscopy     withdrawal significantly improved polyp and adenoma detection. So we designed a prospective,     randomized multicenter study to verify the effect of dynamic position change in colonic     adenoma detection. We think position change improve luminal distension and has the potential     to improve adenoma detection rate.   "
146550|NCT01366066|"     During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in     pressure was observed in the external urethral sphincter along with an increase in bladder     capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve     Stimulation (TMNS) in women could induce pressure increment of the external urethral     sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33     women suffering from urinary stress incontinence were able to contract their pelvic floor     muscles and had become free of symptoms. Another pilot study has shown promising effect on     the overactive bladder syndrome.      The present study aims to treat urinary incontinence and includes 2 groups of patients with     30 patients in each group: Women suffering from urinary stress incontinence and women     suffering from urge incontinence. A medical vibrator is used and in each group the subjects     will be randomized to vibration treatment or no vibration treatment. All patients will     receive pelvic floor training and all women suffering from urge incontinence will receive     anticholinergic medications.      The stimulation will be performed at the perineum every day for 6 weeks with an amplitude of     2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires,     micturition diaries and diaper tests.      If the investigators are able to demonstrate a significant reduction in the incontinence     symptoms in the subjects the investigators asses that vibration can be a way of     reestablishing a normal function of the pelvic floor muscles and bladder function in     incontinent patients.   "
146551|NCT01366053|"     This Phase IV observational trial is intended to identify patients who are failing GnRH     agonist therapy as evidenced by a rising PSA and who have yet to initiate secondary     manoeuvres involving antiandrogens. This group may include both non-metastatic as well as     metastatic patients. The trial will determine if these patients will benefit from switching     to Degarelix. It will assess the effect of Degarelix's direct mode of action on androgen     levels and whether continuous use of Degarelix improves disease progression.      As per the CUA Guidelines for the Management of CRPC, because the androgen receptor remains     active in most patients who have developed castration resistant disease, it is recommended     that ADT should be continued (LEVEL 3, GRADE C). Therefore, it is logical to continue     patients on Degarelix throughout the castrate resistant period. This will allow for the     gathering of data that is currently unknown within this setting, such as the effect of     combined treatment with antiandrogens as well as chemotherapy and other castrate resistant     treatments.   "
146552|NCT01366040|"     This is an open-label, multicenter, survey-based study to determine subject satisfaction with     using the single-use autoinjector for the delivery of AVONEX PS. Enrollment will consist of     200 subjects in a single cohort who have been prescribed AVONEX PEN in accord with its     Product Monograph. All subjects must be experienced AVONEX PS users (i.e., using it for at     least 12 weeks without any support person to help with the injections administered in the     vastus lateralis) and enrolled in MS AllianceTM program (hereinafter, MS Alliance). The     clinic nurse investigator will instruct the patient on the correct method of using AVONEX PEN     and the first injection with Autoinjector, using the subject's own supply, will be completed     in the clinic, with the clinic nurse investigator present. All further injections of AVONEX     PEN will be self-administered at home. The subjects will complete the first set of     questionnaires, including Subject Satisfaction Questionnaire, Ease of Use Grading Scale and     the Autoinjector Instructions Grading Scale, within 10 minutes after the first injection at     the clinic, and will be given another set of questionnaires to be completed at home within 10     minutes following the last study injection 2 months later, provided the subjects still     continue to self-administer their AVONEX PEN. The first set of questionnaires will be left     with the clinic nurse investigator to be sent to the CRO by fax or e-mail, while the second     set will need to be mailed to the CRO by study subjects using the provided self-addressed,     postage-paid envelope.   "
146553|NCT01366027|"     PBA is a neurologic condition that is estimated to impact over a million patients and their     families in the United States. PBA occurs secondary to an otherwise unrelated neurologic     disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying     and/or laughing. Progress has been made in better understanding this debilitating condition,     but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar     Affect RegIstry Series), has been initiated.      The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in     patients with underlying neurologic conditions including        -  Alzheimer's disease        -  Amyotrophic lateral sclerosis        -  Multiple sclerosis        -  Parkinson's disease        -  Stroke        -  Traumatic brain injury      Because this is an observational registry, it doesn't require you to intervene with any     specific treatment or procedure. Your participation allows the PRISM registry to collect and     analyze data from your site and also compare it to national numbers captured in the PRISM     registry about PBA across all of the major at-risk neurologic populations.   "
146554|NCT01366014|"     This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of     investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe     pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety.     Approximately 150 patients from the US will be enrolled in this study.   "
146555|NCT01366001|"     The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when     administered to opioid-experienced cocaine abusers.   "
146556|NCT01365988|"     Objective- To use fMRI to compare brain activity at rest and during memory and decision     making tasks in normal children and in children exposed in utero to drugs of abuse.      Study population- All participants will be 14-20 year-olds enrolled in an ongoing     longitudinal follow up study of children exposed to drugs of abuse in utero funded by NIH. A     subgroup of this study cohort will be invited to participate based on added criteria needed     for scanning studies, such as absence of metal in the body, no significant CNS disease, and     ability to tolerate the scanning environment.      Design- Participants will undergo fMRI scans while performing a memory task, a decision     making task and at rest. Data from participants in the current study may be combined with     those from a previous study (NIDA protocol 417) which now reside in our repository protocol,     8002 and NIDA protocol 455.      Outcome measures- The primary outcome measures will be the difference in BOLD fMRI activation     between drug-exposed participants and those without prenatal exposure to drugs of abuse.   "
146557|NCT01365975|"     Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects     (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate     levels during pregnancy, and/or certain variants in the gene that encodes     methylenetetrahydrofolate reductase (MTHFR), a key enzyme that catalyzes synthesis of     5-methyltetrahydrofolate [the primary methyl donor in most metabolic pathways involving     methylation including DNA methylation] from 5,10 methylenetetrahydrofolate may be associated     with reduced risks of certain adverse events during the prenatal period, birth weight and     certain serious diseases in offspring, while other studies have raised concerns about     increased risks of specific serious disorders. Only one study has examined late health     effects in mothers that might be associated with use of periconceptional folic acid     supplements.      We propose to study potential health benefits and adverse effects of periconceptional folic     acid supplements in a 15-year follow-up of offspring and mothers. In the offspring, we will     evaluate whether periconceptional folic acid supplements reduced risk of external congenital     birth defects and childhood acute lymphoblastic leukemia, and whether risks are reduced or     increased for other pediatric disorders linked with periconceptional folic acid supplements     including asthma, pervasive developmental disorders and autism, diabetes, obesity and blood     pressure. In the mothers, we will assess cardiovascular diseases and associated risk factors,     breast and colorectal cancers and precursor conditions, and other cancers. We will also     conduct exploratory assessment of other serious diseases in mothers.      To increase the limited data on the morbidity and survival of children born with a major     birth defect, particularly in low- or middle-income countries, we plan to assess morbidity     and mortality outcomes in children identified with neural tube defects as part of our     follow-up.      The women and children who participated in the joint China-U.S. Community Intervention     Program (CIP) trial (N=243,779 women treated or not treated with folic acid in the     periconceptional period and their offspring) represent unique cohorts whose periconceptional     exposure to folic acid is well documented. We propose to follow a sample of 22,000 CIP     mothers and their offspring (currently 14 to 17 years of age), to ascertain vital status,     medical history, and lifestyle habits. The study will clarify whether there are differences     with respect to growth, physical development during the puberty period, selected serious     morbidity and mortality in offspring and risks of serious health outcomes and mortality in     mothers associated with periconceptional folic acid supplements. Data from this study will     inform us about cohort participation rate, cost, and effective approaches for future     follow-up of the full cohort.      The current protocol focuses on a pilot study (Pilot Study # 1) in which we will carry out     two specific aims in 500 families. We will test and evaluate the most effective approaches to     trace the mothers who enrolled in the CIP in 1993-1995 in CIP counties, fathers, and     children. If the child is not living with the biological mother, we will trace the caretaker     or next of kin with whom the child is living. We will also conduct in-person interviews,     obtain anthropometric and blood pressure measurements and determine cohort participation rate     in a sample of 500 CIP families from two of the 21 CIP project counties to obtain health     information, medical history, and vital status. We will attempt to enroll in the pilot study     500 mothers/caretakers and 500 offspring, and 500 fathers (Total N=1500). Excluded from the     Pilot Study #1 at this time are the families in which the mother or the child is deceased. We     will seek permission from the IRB to enroll these families at a later date.   "
146558|NCT01365962|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with     rhabdomyosarcoma.   "
146559|NCT01365949|"     RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.      PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing     sarcoma.   "
146560|NCT01365936|"     There have been some controversies regarding the use of preparations with LH activity in     patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity. In this     research we aimed to compare urinary menotrophin versus recombinant FSH (rFSH) with respect     to the prevention of OHSS   "
146561|NCT01365923|"     During recovery from general anesthesia the stimuli of endotracheal tube lead to the     coughing, hypertension, tachycardia, which can cause a serious complication. Especially the     postoperative course of patients emerging from general anesthesia after intracranial surgery     is frequently complicated by the occurrence of hypertension and coughing event.      It has been demonstrated that opioid, intravenous or topical lidocaine administration can     attenuate the coughing reflex. Administered the opioid before emergence, it is effective to     prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.      However, remifentanil is an opioid widely used because of rapid context-sensitive half-life,     target-controled infusion method to adequately maintain the effect site concentration could     help to predict the recovery time to the alert state from the general anesthesia. It is     considered proper method of continuous infusion of remifentanil for reducing emergence cough.      Dexmedetomidine , a potent alpha adrenoceptor agonist which dose-dependently reduces arterial     blood pressure and heart rate, decreases the hemodynamic and and catecholamine response to     intubation and extubation. It is thus theologically appropriate for reducing airway and     circulatory reflexes during emergence from anesthesia.      In this study, the investigators used bolus dexmedetomidine immediately before extubation,     and compared the effects on coughing, hemodynamic response and recovery profile to a     continuous infusion of remifentanil.   "
146562|NCT01365910|"     This phase II trial studies how well Linifanib works in treating patients with advanced,     refractory colorectal cancer expressing k-Ras mutations. Linifanib may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
146565|NCT01365871|"     The current standard for pain relief during prostate biopsy is the injection of local     anesthetic agents into or around the prostate at various sites including apex, base, lateral     aspects and into the prostate itself. Despite such anesthetic injection, some men still     experience severe pain and often at the base of the penis. The study audits current practices     comparing the degree of pain relief provided by injection at basal versus basal+apical sites.     All these injection sites are standard practice at our hospital.   "
146566|NCT01365858|"     -  Background : The general experience with the Virtual Reality application approach          suggests that this treatment concept is promising in stroke rehabilitation        -  Purpose : In shopping activity in a real supermarket and in simulated with the          investigators virtual shopping simulation (VAP-S = virtual action planning supermarket),          the investigators will compare people who had undergone a stroke who receive          conventional rehabilitation or virtual training in VAP-S.   "
146567|NCT01365845|"     The purpose of this study is to determine if proton radiation therapy will reduce the amount     of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of     any cardiac side effects.   "
146568|NCT01365832|"     C-reactive protein (CRP) is directly implicated in atherogenesis and associated     cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous     Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and     thus consequently improve disease-related cardiovascular morbidity. However, the influence of     gender on the CRP evolution pattern has never been assessed before. The aim of our study was     to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months     after the start of effective CPAP treatment.   "
146569|NCT01365819|"     Methamphetamine (MA) dependence is a source of continuing danger for both individuals and     society. While there are some behavioral treatments, they are not always effective. To date,     there are no medications available to treatment methamphetamine dependence. There is some     early evidence suggesting that varenicline (also known as Chantix(tm)) may help people to     stop or reduce their use of methamphetamine. Varenicline is already on the market in the U.S.     for cigarette smoking cessation and shows promise for treating alcohol dependence. In order     to determine if varenicline can help people stop using methamphetamine, we will enroll 90     methamphetamine-dependent people who are looking for treatment into the study at the UCLA     Vine Street Clinic operated by Dr Shoptaw of UCLA. Half will receive varenicline (n=45) and     half will receive placebo (n=45) which will be determined randomly. Everyone will receive     talk therapy for methamphetamine dependence. People will take the medication for 9 weeks     followed by a 4 week follow-up period. Before receiving any medication, participants will     complete a maximum 2 week (6 study visits) lead-in to complete baseline assessments,     psychological and medical evaluation, and comprehensive assessment of drug use to determine     study eligibility. If a person is eligible for the study, s/he will receive either     varenicline or placebo. Participants will visit the UCLA Vine Street Clinic (UCLA VSC) three     times a week study visits. At the end of the medication phase, subjects will complete a four     week follow up period for safety monitoring.   "
146570|NCT01365806|"     The long-term goal of this research is to apply novel technology for detection of donor organ     (allograft) rejection to improve patient outcomes following heart transplantation. The     specific goal of this study is to determine whether daily monitoring of the transplant     recipient's electrocardiogram (ECG) using a simple home device with transmission to an ECG     Core Laboratory would provide an early biomarker for acute rejection. Despite routine     immunosuppressant drug therapy, acute rejection is common, especially within the first 6     months following transplant surgery. To detect rejection, frequent endomyocardial biopsies of     heart tissue are performed. An endomyocardial biopsy is a costly and invasive procedure     performed in a hospital cardiac catheterization laboratory that has associated risks. Recent     evidence suggests that acute allograft rejection causes delays in ventricular repolarization     resulting in a longer QT interval on the ECG. The specific aims of the study are to: 1)     determine whether an increase in the QT interval during the first 6 months following heart     transplant is a sensitive and specific biomarker for acute rejection; and 2) determine the     timing of QT interval increases relative to biopsy-diagnosed stages of mild/moderate/severe     rejection. The potential benefit of finding a simple ECG biomarker of allograph rejection     that could be measured at home is that it might yield earlier detection of rejection, allow     more timely therapy and reduce mortality from acute allograft rejection.   "
146571|NCT01365793|"     The investigators will conduct a randomized controlled trial comparing four different     intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two     rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of     these two basic rehydration protocols, the investigators will vary the type of rehydration     fluid used (0.9% saline or 0.45% saline). The investigators will compare the different     treatments by conducting assessments of neurological injury, by measuring the frequency of     significant cerebral edema, and by measuring long-term neurocognitive function.      These studies will allow us to determine whether variations in IV fluid treatment protocols     affect acute neurological outcomes of DKA. Additionally, they will provide important data     regarding the impact of DKA and DKA treatment on long-term neurocognitive function in     children. In this way, the investigators hope to identify a more ideal fluid management     strategy for children with DKA.      Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and     that brain injury might result from this reduction in blood flow and/or the effects of     re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The     investigators hypothesize that more rapidly re-establishing normal blood flow to the brain     during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt)     content, will help to minimize brain injury caused by DKA.   "
146572|NCT01365780|"     This project is meant to show wether the HBOT can fasten the recovery process after surgical     treatment of distal Radius fractures. For this propose the microcirculation is measured,     together with the level of pain on a visual analog scale (VAS) and the remaining force of the     hand after surgery is examined. Furthermore the sonography with contrast medium which is long     established for examination of organs of the parenchyma, is meant to be verified at the     muscular-skeletal system in this project.   "
146575|NCT01365741|"     The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a     thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.      The study aims to mimic the treatment Danish patients receive when admitted to the hospital     with a ST-elevation myocardial infarction since these patients are refereed to acute     Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic     inhibition.      Current guidelines recommend the administration of Efient right before the PCI procedure,     while the patient is lying down, either in the ambulance or in the operating room. We, the     investigators, believe that this is suboptimal for the patient, since any sort of prolonged     inhibition time will possibly worsen the patients prognosis and make the patient more prone     to later clotting issues.      Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright     position and making them sit up for 2 minutes after ingestion, the effect of the pills will     commence faster than if taken in a supine position. This will possibly lead to faster     inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting     issues during and after the procedure.   "
146576|NCT01365728|"     The purpose of the study is to compare the results of LASIK surgery when using two versions     of a femtosecond laser in patients with nearsightedness with and without astigmatism.   "
146577|NCT01365715|"     The main purpose of this study is to assess the efficacy of preoperative embolization in     decreasing operative blood loss, decreasing the need for intraoperative transfusion and     facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at     describing the vascularity in a series of spinal metastasis, and to correlate this with     perioperative blood loss.   "
146578|NCT01365702|"     The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow     obstruction due to Tuberculosis (TB) destroyed lung.   "
146579|NCT01365676|"     2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as     antidepressant will be prescribed together for treating women with Premenstrual Syndrome     (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE®     prescription alone.   "
146580|NCT01365663|"     The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.   "
146581|NCT01365650|"     This was an open label, three way study in participants with symptomatic allergic rhinitis.     The following 3 treatments were administered to each subject during dosing periods 1, 2 and     3, respectively:        -  Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray          into each nostril) on Day 1 of Period 1.        -  Treatment B: Single intranasal dose of oxymetazoline hydrochloride followed by a single          intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30          minutes later on Day 1 of Period 2.        -  Treatment C: Seven days of treatment with intranasal fluticasone propionate (between          Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine          (one 15 mg spray into each nostril) on Day 1 of Period 3.      Subjects remained resident in the Clinical Unit from Day 1 until the morning of Day 2 in each     period and there was a washout period of 2 to 7 days between periods. A post study medical     was performed within 7 days of Period 3.      The objectives of this study were:        -  To assess the pharmacokinetics (PK) of intranasal ketorolac in participants with          symptomatic allergic rhinitis.        -  To assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the          pharmacokinetics and tolerability of intranasal ketorolac in participants with          symptomatic allergic rhinitis.        -  To assess the effects of chronic administration of fluticasone propionate on the          bioavailability and tolerability of intranasal ketorolac in participants with          symptomatic allergic rhinitis.   "
146582|NCT01365637|"     The purpose of the study is primarily to determine the safety and toleration and     pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.     Dosing will either be administered twice or three times daily. Secondary objectives will be     to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on     the PK of PF-05089771.   "
146583|NCT01365624|"     This study had an open-label, single-dose design. All subjects received a single dose of 30     mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were     obtained pre-dose and at specified time points over 24 hours post-dose.      The primary objective of this trial was to compare the pharmacokinetics of intranasal     ketorolac between elderly and nonelderly adult subjects. The secondary objective was to     evaluate the safety profile of intranasal ketorolac in elderly subjects.   "
146584|NCT01365611|"     This was a non-randomized, open label study in healthy male and female volunteers. A single     intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1     and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone     propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of     Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7,     and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study     medical was performed within 7 days of study completion.      The objective of this study was to assess the effects of chronic administration of     fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and     female subjects.   "
146585|NCT01365598|"     The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine     compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the     infected human host to prevent transmission of falciparum malaria to the anopheles mosquito     vector.   "
146586|NCT01365585|"     The objective of this observational study is to gain clinical insight on the actual use of     sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The     primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three     times daily for the treatment of PAH.   "
146600|NCT01365403|"     This open-label, fixed sequence, two-period study will assess the effect of multiple dose     carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a     single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of     3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose     of RO4917838 on Day 16.   "
146601|NCT01365390|"     The aim of this study is to provide baseline acute otitis media data in East European     countries.   "
146587|NCT01365572|"     The purpose of this study is to evaluate the feasibility, safety, and effectiveness of     EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following     drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic     and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM     or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment     with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators     will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent     implantation in patients with restenosis after DES   "
146588|NCT01365559|"     This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple     Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the     same bortezomib-containing combination regimen to which a MM patient has progressed while     receiving. This study will enroll 45 patients total. These patients will be resistant to     bortezomib as demonstrated by progressive disease while on bortezomib or have relapsed within     12 weeks of the last dose of bortezomib in a combination regimen. Patients will be     sub-divided into 2 groups in this study, treatments containing (Group A) or not containing     immunomodulatory drugs (IMiDs) (Group B). Thirty patient will be enrolled into Group A and 15     patients into Group B for a total of 45 patients. Patients must have received 4 doses of a     minimum of 1.0 mg/m^2 of bortezomib in no more than 4 weeks per cycle. Patients must have     received at least one cycle meeting this definition and have shown progressive disease to be     considered eligible. Patients who have been refractory to or relapsed within 12 weeks of the     last dose of bortezomib in their most recent bortezomib-containing regimen that does not     include either thalidomide or lenalidomide are eligible regardless of when patients received     that regimen, as long as they meet the above criteria.      Carfilzomib will subsequently replace bortezomib using the patient's most recent     bortezomib-containing regimen to which the patient progressed while receiving. Patients will     be eligible if they progressed from bortezomib with an alkylating agent (melphalan or     cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin) and/or a     glucocorticosteroid (prednisone, dexamethasone or medrol)and IMiD (thalidomide or     lenalidomide). The study will consist of a screening period, followed by up to eight open     label treatment cycles, a final assessment to occur 28 days after the end of the last     treatment cycle, a follow-up period and maintenance cycles of single agent carfilzomib.      Patient who complete the combination treatment period without progressive disease will be     eligible for maintenance therapy with single-agent carfilzomib. During maintenance therapy     carfilzomib will be administered at the same dose given during the last cycle of combination     treatment.   "
146589|NCT01365546|"     Proportion of surgeries in which the primary endpoint (overall assessment) is classified as     success.   "
146590|NCT01365533|"     The study was a double-blind, placebo-controlled, crossover study to evaluate the efficacy of     roflumilast on airway inflammation and function in patients with allergen-induced asthma.      Individuals with stable, mild to moderate allergic asthma, with a history of episodic wheeze     and shortness of breath, were eligible for enrollment.   "
146591|NCT01365520|"     This trial is conducted in Asia and Europe. The aim of the trial is to investigate the     pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single     dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A.     Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part     B) (NCT00840086).   "
146592|NCT01365507|"     This trial is conducted in Asia and North America. The aim of this trial is to compare the     efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve     subjects with type 2 diabetes mellitus when using two different titration algorithms (dose     individually adjusted) as add-on to subject's ongoing treatment with metformin.   "
146593|NCT01365494|"     This study was planned to establish the non-inferiority of Rabipur administered as simulated     post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult     subjects.   "
146594|NCT01365481|"     The purpose of this study is to assess the long-term safety and tolerability profile of     valsartan and valsartan-based treatments in children with hypertension, with or without     chronic kidney disease.   "
146595|NCT01365468|"     This study was to evaluate the antitumor activity and safety of RAD001 in patients with     Plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).      The aim of the study was to :        1. determine whether RAD001, administrated orally daily on a continuous dosing schedule          might:             1. Increases time to disease progression (TTP) based on volumetric MRI measurements in               children and adults with NF1 in inoperable documented progressive PN (stratum 1).             2. Results in objective radiographic responses based on volumetric MRI measurements in               children and adults with NF1 and inoperable PN in the absence of documented               radiographic progression at the trail entry (stratum        2. To evaluate the tolerability and toxicity of chronic RAD001 administration in this          patient population as assessed by the NCI Common Toxicity Criteria, version 4.0.   "
146596|NCT01365455|"     This study will assess the safety and efficacy of secukinumab compared to placebo in patients     that have moderate to severe, chronic, plaque-type psoriasis.   "
146597|NCT01365442|"     The purpose of this study is to provide evidence for policymakers and key opinion leaders on     the pilot implementation of cholera vaccination using the newly licensed Oral Cholera Vaccine     (OCV) in India. The pilot introduction will provide the evidence for the feasibility, costs     and population acceptance of large-scale cholera vaccination using the Indian vaccine (using     vaccination coverage rates and other measures).   "
146598|NCT01365429|"     Human donor lungs that do not meet the standard clinical criteria for donor lung utilization     but fit into the study inclusion criteria will be retrieved from the donor using current     donor lung retrieval techniques.   "
146599|NCT01365416|"     The prevalence of morbid obesity (BMI > 40 kg/m2) is increasing rapidly in the UK, but the     investigators lack a coherent strategy for detailed assessment and treatment of the     individuals affected, who are at high risk of morbidity and early mortality. The     investigators already know that more than 1 in 20 severely-obese individuals have a simple     genetic cause of their obesity (usually inherited in an autosomal dominant pattern. Bariatric     surgery is the most effective treatment for morbid obesity and certain surgeries can result     in the remission of type 2 diabetes. However, some patient fail to achieve the weight loss or     experience complications and re-operations. The investigators are unable to predict the     outcomes of bariatric surgery particularly in relation to type 2 diabetes remission which is     crucial for the assessment of risk to benefit balance before wider future applications of the     surgery.      The investigators want to investigate the mechanism underlying Type 2 diabetes remission     after bariatric surgery by A) examining the effect of Mendelian forms of obesity and diabetes     on T2D remission, B) studying changes in expression profiling patterns in insulin-responsive     tissues, C) identifying of eQTLs, and of other genetic variations affecting T2D remission and     D) studying the role of epigenetic variation in T2D remission.   "
146674|NCT01364428|"     This trial is conducted in the United States of America (USA). The aim of this trial is to     compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in     subjects with type 2 diabetes.   "
146602|NCT01365377|"     Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk     factors are known: disease severity, age, gender. Another risk factor is lack of information     from the medical staff and nurses.      Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS).     Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R)     is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey     (SF-36) is an assessment of life quality.      In the following study, the investigators will evaluate the impact of a brochure as     complement of oral information on Anxiety developed by relatives and family of ICU patients.      The medical and surgical ICU is composed by two different units (different medical and nurse     team, different location in the same hospital) of 12 beds on one side, 14 beds on the other     side.      During a year, in the first unit, the investigators will use the booklet as support and     complement of oral information : booklet arm. The information process will be as usual in     the other unit : control arm. During the second year, the booklet will be used in the     second unit while the first unit will return to the usual oral information (cross-over).      For each included patient, one relative or family member is pointed to be the referring     family member or referent. This referent receives the HADS questionnaire at Day 3 after     admission, at day of discharge if the patient is alive, at one month after discharge. The     IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36     questionnaire is given to the referent and the living patient at day 30. The day 30     questionnaires are send by mail at the referent address.   "
146603|NCT01365364|"     Restless legs syndrome and periodic limb movement (PLM)are sleep-related movement disorders     and studies have shown changes in striatal dopaminergic activity in patients with these     disorders. Physical exercise has been shown to improve the symptoms of restless legs syndrome     and PLM, as has treatment with dopamine agonists. However, the mechanism by which physical     exercise acts as a non-pharmacological treatment in improving symptoms of restless legs     syndrome and PLM remains unknown. The investigators evaluated dopamine transporter density     profiles in 16 sedentary patients (control and experimental - with PLM, groups) and the     influence of acute physical exercise on its concentration after a maximal exercise test. Each     patient underwent baseline polysomnography to evaluate sleep patterns and PLM index values.     After obtaining the polysomnography baseline, the single photon emission computer tomography     baseline was determined. Subsequently, the volunteers performed a maximal exercise test in     the morning, followed by a single photon emission computer tomography two hours later and     polysomnography that night, to assess the effect of acute physical exercise on dopamine     transporter and sleep patterns. The results showed significant lower dopamine transporter     baseline densities in the striatum region for the experimental group. The results also showed     a significant reduction in the periodic leg movement rate in the experimental group and a     significant increased percentage of stage-1 non-REM sleep in both groups after maximal     exercise test. Significant differences between the groups were only observed for Stage 2     sleep and slow wave sleep. Our results show that patients with PLM had a lower dopamine     transporter density in the left putamen region compared to the control group and an acute     physical exercise (maximal exercise test) did not alter this profile, providing evidence that     this improvement is the result of chronic physical exercise.   "
146604|NCT01365351|"     The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary     short stature in children with insufficient growth hormone production and/or short stature     caused by Turner syndrome.   "
146605|NCT01365338|"     This study aims to determine whether the drug affects brain activity in healthy volunteers,     either when the participants are performing a memory task, or when lying at rest. Subjects     will undergo a brain scan under both of these conditions after a dose of either the study     drug or a placebo is administered.   "
146606|NCT01365325|"     The aim of the study is to compare two different home monitoring care programs in patients     with chronic heart failure in functional class NYHA III, one of them based on clinical and     electrocardiographic evaluations, the other one using also periodical handled     echocardiographic examinations.   "
146607|NCT01365312|"     Appropriate delivery of adequate nutrition and medications in premature infants often     requires central venous access in the form of a special IV called a PICC (peripherally     inserted central catheter). While a necessary feature of neonatal intensive care, PICCs pose     significant risk: among the most serious of these is infection. One common, successful     infection control practice used in older children and adults involves the use of a lock, in     which a fluid-filled syringe is attached to the end of an IV when it is not in use in order     to prevent and/or treat clotting or infection. The solution is left for some period of time     and is then either withdrawn from the line or flushed into the patient. The solution could be     saline, antibiotics, other antiseptics, or any combination of these. However in the premature     infant, use of antibiotics as a locking compound risks leaving behind organisms resistant to     treatment; antiseptics can irritate vessels and cause breakage to sensitive premature skin;     saline has neither sterilization nor anti-infective properties. By contrast, ethanol     neutralizes or kills most bacteria, viruses, and fungi without the risk of resistance, and     because it is not externally applied there is no risk to baby skin. Ethanol-based lock     protocols have been used safely and effectively in both adult and pediatric populations     without adverse effects, but this has not been tested in premature babies because fluids and     medication are delivered continuously: placement of a lock traditionally requires an extended     pause (hours or days) in fluid and medication administration.      To overcome these key limitations, a periodic, brief ethanol lock protocol was designed such     that both infant exposure and interruptions to fluid and medication delivery would be     minimized. The lock is practical, cheap, easy to place, and takes advantage of an existing     daily pause during which IV tubing and fluids hooked up to the PICC are changed. The     objective of this study is to test the hypothesis that use of a 70% ethanol lock, every 3rd     day, for 15 minutes, will safely and effectively reduce PICC infection in our unit.   "
146608|NCT01365286|"     The purpose of this study is to investigate heart rate lowering efficacy and respiratory     safety of ivabradine in patients with asthma and COPD.   "
146609|NCT01365273|"     This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5     centres in the US with deep-partial of full thickness burns in need of skin grafts will be     enrolled.The subjects will be equally randomised to either treatment with Mepitel One or     bridal veil together with staples.      The primary objective is to compare pain at the time of dressing change for the use of     Mepitel One versus bridal veil together with staples on deep partial or full thickness burns     requiring skin grafts.   "
146610|NCT01365260|"     The purpose of this study is to determine whether MM-II is effective in the treatment of     osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.   "
146611|NCT01365247|"     This treatment intervention trial is designed for men and women with substance dependence and     comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one     of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and Substance     Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy] and an active     monitoring control group) and will be evaluated at baseline and four follow-up points     (post-treatment, 1-month, 2- month and 3-month post-treatment).   "
146675|NCT01364415|"     This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced     Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics     and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.   "
146612|NCT01365234|"     Heart failure is a progressive disease that decreases the pumping action of the heart. This     may cause a backup of fluid in the heart and may result in heart beat changes. When there are     changes in the heart beat sometimes an implantable heart device is used to control the rate     and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of     the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may     be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the     upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles     through three leads (flexible insulated wires) that are inserted through the veins to the     heart. The purpose of this study is to evaluate a new lead for delivering energy to the left     ventricle (bottom left chamber of the heart).   "
146613|NCT01365221|"     The primary objective of this study is to compare platelet reactivity between patients     receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients     receiving only a loading dose of prasugrel.   "
146614|NCT01365208|"     The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow     earlier and more detection of drug response in advanced NPC than RECIST method, in patients     with previously untreated advanced NPC who will receive platinum-based chemotherapy. This     study will also determine if this new method can predict survival in these patients. This     study may have far-reaching impact on drug development in NPC as it may offer a more optimal     way of evaluating drug efficacy in clinical trials and also in clinical management.   "
146615|NCT01365195|"     The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic     adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management     and on the later recovery after surgery in patients undergoing colorectal surgery.   "
146616|NCT01365182|"     This intervention program combines biofeedback PFME with a telephone or support group     intervention to treat persistent urinary incontinence (UI). The study's primary aims are to     improve continence, quality of life, and mood through enhancing adherence to PFME and     self-management of incontinence symptoms. The secondary aims are to examine the physiological     effects and cost effectiveness of the proposed interventions.   "
146617|NCT01365169|"     Objectives:      To explore the feasibility and acceptability in diverse samples of cancer patients of     wireless collection and transmission of data for transfer into the open-source     cyberinfrastructure (CI) called CYCORE   "
146618|NCT01365156|"     The goal of this clinical research study is to learn if a surgical procedure called an     extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation     therapy can help to control the disease for a longer time than standard-of-care chemotherapy     and whole pelvic radiation therapy.   "
146619|NCT01365143|"     To date, no study has prospectively compared open versus robotic radical prostatectomy in a     randomized fashion for patients with prostate cancer. For patients with newly diagnosed     prostate cancer who choose surgical management, the choice of surgical approach is often     limited to surgeon preference and experience. This study will prospectively randomize     patients with localized prostate cancer who are candidates for surgical management to open     versus robotic radical prostatectomy.   "
146620|NCT01365130|"     The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety     and side effects for patients with advanced gastroesophageal cancer   "
146621|NCT01365117|"     Phase 1 clinical trial to evaluate insulin exposure using different formulations of     Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.   "
146622|NCT01365104|"     The purpose of this study is determine if the iron chelator, desferrioxamine can increase     blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there     is a corresponding increase in blood flow to the brain.   "
146623|NCT01365091|"     To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin,     5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with     saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted     and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin     in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and     metformin, 1000-mg XR tablets administered together in both the fasted and fed states.   "
146624|NCT01365078|"     Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the     risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or     C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this     conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus,     providing oils rich in SDA may increase the endogenous synthesis of EPA. This may     subsequently lower serum triacylglycerol concentrations, an effect frequently observed after     EPA supplementation, especially in people with increased triacylglycerol levels.      The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol     concentrations in healthy overweight and slightly obese men and women. The minor objective is     to study the effects of echium oil on the omega-3 index, which is negatively related to     cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.   "
146625|NCT01365065|"     The objective of the study is to assess the safety and ability of vorinostat, a drug     currently licensed for the treatment of a type of lymphoma, to 'turn on' dormant HIV infected     CD4 T-cells.   "
146626|NCT01365052|"     The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and     diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to     placebo (capsules containing no drug) when taken for 10 days.   "
146627|NCT01365039|"     This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact     lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by     current soft contact lens wearers on a daily disposable wear basis.   "
146676|NCT01364402|"     This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule     for primary PCI or elective PCI will randomly allocated to receive either a single dose of     EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.      The investigators assume that the incidence rate of CIN will be significantly lower in the     EPO group compared to placebo. In addition, EPO administration will result in a decrease of     infarct size.   "
146628|NCT01365026|"     The potential health gains from healthy lifestyles are very well-known, what is still not     known is how to help people to adopt these lifestyles, by means of brief interventions     feasible in routine general practice. This study was designed to explore the feasibility and     efficacy of innovative implementation strategies for the promotion physical activity, diet     and smoking abstinence in primary care. The investigators hypothesize that collegiate     planning between practitioners, researchers and managers, with a socio-ecological perspective     and taking into account the real context of collaborating centers, will guarantee the     sustainability and effectiveness of these programs.   "
146629|NCT01365013|"     The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN     Euskadi program for the primary prevention of type-II diabetes in high-risk population seen     in primary care centers (Osakidetza-Basque Health Service) in which such intervention is     implemented, compared to usual care control centers.   "
146630|NCT01365000|"     The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy     Subjects.   "
146631|NCT01364987|"     This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in     healthy volunteers.   "
146632|NCT01364974|"     The objective of this study is to explore safety and tolerability of multiple oral doses of     ASP015K in healthy volunteers.   "
146633|NCT01364961|"     Although much effort has been done to lower LDL-cholesterol concentrations, there is still a     substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD     is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that     elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite     many initiatives, no new widely applicable intervention strategies with proven efficacy have     been developed.      Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower     risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert     a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has     been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to     elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human     intervention studies.   "
146634|NCT01364948|"     The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits     even more vulnerability to the environment due to poor self regulatory heat mechanisms,     paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight     as water loss from their skin during the first week of life. Many strategies have been     utilized by neonatologists to decrease this water loss. Oil application on the skin can act     as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut     oil, often used for traditional massage of babies by Indian communities, is culturally     acceptable and Hence the investigators decided to undertake this study to objectively assess     the reduction in water loss from skin after oil application   "
146635|NCT01364935|"     Comparative study to determine whether several fertility monitoring products - the     DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are     substantially equivalent in performance, and secondarily to determine the appropriateness of     labeling information for the DuoFertility monitor.   "
146636|NCT01364922|"     The primary purpose of this study was to evaluate the analgesic effect and safety of     hydrocodone/acetaminophen extended release compared to placebo.   "
146637|NCT01364909|"     This study will investigate whether early exercise in critically ill patients will decrease     inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.   "
146638|NCT01364896|"     This is an observational cohort study with two time points (baseline and after at least 6     months of treatment with a non-corticosteroid immunosuppressive agent for inflammatory bowel     disease (IBD)). Approximately 40 participants, both male and female, 18 years of age and     older will be recruited from the Pittsburgh IBD Cohort.      Participants will have a histological diagnosis of IBD (Ulcerative Colitis (UC) or Crohn's     Disease (CD)) and will be attending for colonoscopy prior to starting a non-corticosteroid     immunosuppressive agent as part of standard medical care. Immediately following the     colonoscopy, an anal exam will be performed for research purposes to include:        1. Perianal inspection        2. Anal canal HPV swab        3. Anal cytology        4. Digital anal examination        5. High resolution anoscopy (HRA) and biopsy of all lesions with visual criteria consistent          with high-grade anal dysplasia        6. For female participants a self- or clinician-taken vaginal swab for HPV typing.      These procedures will be repeated at routine colonoscopy following at least 6 months but     within 12 months of non-corticosteroid immunosuppressive treatment.   "
146639|NCT01364883|"     This is an open label phase I study, to assess the safety and immunogenicity of novel     schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP.     These vaccines have been evaluated previously in a number of clinical trials proved to be     safe and capable of inducing protective cellular immune response following challenge with the     parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63     ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA     ME-TRAP according to various schedules.. Safety data will be collected for each of the seven     regimens. Secondary aims of this study will be to assess the immune responses generated by     each of these regimes.   "
146640|NCT01364870|"     Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia.     Minimizing the severe pain experienced during required activities in the immediate     postoperative period will promote functional recovery and prevent the development of new     chronic pain syndromes.   "
146641|NCT01364857|"     Port Wine Stain on a limb can be either isolated or associated with complications (venous or     orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes     (Klippel-Trenaunay syndrome,Parkes-Weber syndrome).      Little is known about epidemiology of port wine stains: their evolution during the growth of     the child, the frequency of complications, genetic data, and prognostic factors.      This prospective french national cohort will help for : description of the evolution of port     wine stain and possible complications; prognostic factors for complications ; association     with mutations of RASA1 gene; quality of life of these children. It will also help for global     appreciation of the management of this disease in France.   "
146642|NCT01364844|"     This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability,     identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your     body does to process the drugs and how your body gets them out of your system.) and     pharmacodynamics (PDy) (Pharmacodynamics is a study of what a drug does to your body)     properties in subjects with advanced solid malignant tumors. This study will include 2 parts:     part 1-Dose Escalation and part 2-Dose Expansion.      Study Hypothesis: DS-7423 will be safe and tolerable, and will exhibit acceptable PK and PDy     properties in subjects with advanced solid malignant tumors for whom standard therapy has     failed or for whom no standard therapy exists.   "
146643|NCT01364831|"     In the last few decades much knowledge has been accumulated on the connection between     healthy, sufficient sleep and overall health, cognitive function, memory and job or school     performance, motor vehicle accidents and work accidents. There has been growing awareness     recently of the connection between physical activity and competitive sports performance, and     the amount and quality of sleep. Despite the dearth of scientific studies, there is a     constant effort to improve understanding in this field.      An appropriate procedure designed to evaluate the influence of the quality and amount of     sleep on ability and athletic performance must fulfill a number of basic requirements:        1. Isolating the influence of components related to sleep homeostasis and factors relating          to circadian rhythm.        2. Neutralizing as much as possible the influence of motivation on the evaluation - one          must presumably include a significant competitive event (it is not always possible to do          a simple extrapolation between physiological measurements and competitive performance).        3. Isolating and canceling as much as possible additional factors affecting performance,          such as: home advantage, weather, injury and field conditions.      Athletic activity includes not just competitions but also training towards competitions,     since it is difficult to control for influences of competitions and other occasional events,     in this study the investigators focus on evaluation of the connection between sleep and     athletic performance in training.      Towards the end of adolescence, youth are busy in multiple activities related to studies,     social obligations and athletic activity. This is also the age they learn to drive. This is     an age in which physiologically a person needs more sleep relative to at other ages (9.25     hours of sleep a day), and paradoxically due to the multiple obligations the amount of sleep     is lower than needed.      Beyond the effect on mood, cognitive performance and memory, sleep deprivation causes     far-reaching changes in multiple systems, such as:      Cardiovascular System:        -  Many studies show that shortened sleep duration constitutes an independent cause of          increased cardiac events.        -  Resting heart rate and maximum heart rate decrease after 30 hours of sleep deprivation.      Respiratory System:        -  Significant decline in respiratory function as measured by: FVC, Maximal voluntary          ventilation, Maximal static inspiratory/expiratory pressures, Time to exhaustion with          exercise, Peak O2 consumption, Peak CO2 production.        -  Worsening of respiratory sleep disturbances.      Digestive System:      • Changes in food consumption accompanied by changes in body weight.      Neurophysiological System      • Disturbance of thermoregulation.      Endocrine System:        -  Hormonal changes associated with hypothalamic-hypophyseal axis        -  Influence on secretion of Ghrelin and leptin        -  Influence on secretion of growth hormone.      In light of this, there is sound basis for the presumption that athletic performance is     connected to these influences directly and indirectly.      The purpose of this study is to evaluate the connection between sleep quality and duration     and athletic performance among young athletes living and training at the Sport-Gifted Centre     at the Wingate Institute.   "
146644|NCT01364818|"     The purpose of the proposed research is to study the potential changes in biomarkers of     patients with neurodevelopmental disorders in response to treatment in clinical trials or in     private psychiatry practice utilizing non-invasive psychophysiological measurements. The     investigators plan to obtain psychophysical measurements throughout several periods of     treatment.   "
146645|NCT01364805|"     In the United States, approximately 30,000 new cases of pancreatic cancer are diagnosed each     year and an almost equal number of deaths are related to this cancer. Different types of     chemotherapeutic treatments are used that target different parts of the cancer cell with some     success, but there is room for other treatment options.      It is known that people with cancer are using high doses of intravenous vitamin C also known     as ascorbate, as a cancer treatment and this is occurring frequently. When Vitamin C is given     in this manner, it is not taken by mouth; instead, it enters your body through an IV     (intravenous) site, or tube that is inserted through a needle into your vein. If you have a     port-a-cath in place, the IV will be given using your port. When Vitamin C enters your body     through an IV site, it is known that it acts like a drug and not a vitamin. It produces a     substance around the cancer cells called hydrogen peroxide. It has been seen in animal     research studies that hydrogen peroxide kills the cancer cells while leaving the normal cells     unharmed.      Currently the FDA does not approve the use of high-dose intravenous Vitamin C as a cancer     treatment. The use of intravenous Vitamin C in this study is experimental. Furthermore, it is     important to know that we do not expect the intravenous Vitamin C given in this study to be     healing for the treatment of your cancer.   "
146646|NCT01364792|"     This is a one-week, randomized, double blind add-on study of valaciclovir versus placebo in     24 clinical patients with Schizophrenia according to DSM IV, currently experiencing psychosis     as is defined by the positive items of the Positive and Negative Syndrome Scale (PANNS)     score, being five or higher on one item or four on two items of this scale. Each patient will     be randomized to double blind treatment with either valaciclovir or placebo for one week.      The main objective is to find a pre- and post-valaciclovir treatment difference in     hippocampal inflammation, as measured with positron emission tomography. The secondary     objective is to improve cognition by the supposed anti-inflammatory effect on the hippocampus     of valaciclovir. This is measured by pre- and post-treatment performance on the PANSS, the     attention and memory test.      Both the treatment team and the patient will remain blinded during the course of the study.     Following the active treatment phase, patients will receive treatment as clinically     indicated.   "
146647|NCT01364779|"     The primary objective of the study is to determine the prevalence of aspirin resistance in     chronic kidney disease patients. The secondary objectives are to determine possible risk     factors contributing to aspirin resistance in this population.   "
146648|NCT01364766|"     The purpose of this study is to find the impact of continuous blood glucose sensors use in     the classroom/school environment. We will be asking the subject,subject's parent and     subject's teachers to complete a short survey/questionnaire. The survey will take     approximately 10-15 minutes.   "
146649|NCT01364753|"     Our overall goal has been twofold: 1) to evaluate whether there are significant age-related     changes in flight simulator performance near age 60, and 2) to assess whether there is an     alternative model that can explain longitudinal flight simulator performance on the basis of     measures of cognitive function and expertise.   "
146650|NCT01364740|"     Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep     Apnea.   "
146651|NCT01364727|"     A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or     thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for     thymic cancers.   "
146652|NCT01364714|"     Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors     report persevering limitation of physical capacity for years after discharge. Limited     information is available about the underlying biomechanical properties responsible for this     muscle function impairment.   "
146653|NCT01364701|"     Clinical effectiveness is of the finest tools to evaluate treatment success and is combined     of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3     main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics,     it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be     beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to     compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus     single maximal dose PDE5i therapy.   "
146654|NCT01364688|"     Active vitamin D at therapeutic dose may prevent vascular calcification but in     supraphysiologic dose may precipitate it.   "
146655|NCT01364675|"     The purpose of this study is to determine whether treating pre-diabetic & pre-hypertensive     individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus     anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower     Cardiovascular Disease (CVD) events.   "
146656|NCT01364662|"     This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and     safety study in children with impulsive aggression comorbid with     Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and     female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120     subjects will be randomized across approximately 30 US centers to one of four treatment     groups.   "
146657|NCT01364649|"     The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily     (QD), compared with escitalopram on sexual functioning.   "
146658|NCT01364636|"     Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF     patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a     prognostic marker of mortality in Acute HF;NGAL is a novel biomarker of Acute Kidney Injury     released in 2 hours, and addressed in several different clinical scenarios(contrast injury,     cardiopulmonary bypass, critical illness.      Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER).      Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL     to predict the development of CRS type 1 in patients admitted to the Emergency Room.      Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes     (length of hospitalization, death, institution of renal replacement therapy, use of     vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in     adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of     renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF     that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the     association of drugs commonly used for HF management, which might influence the evolutionary     behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision     making.      Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to     the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense.      Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis;     Predictive performance of the cut-off: sensibility, specificity, likelihood ratio, predictive     value, accuracy; Identification of variables to predict CRS: logistic regression and     square-Qui test; Correlations analysis of normally distributed variables: Pearson's linear     correlation test; Mean values for normally distributed variables: Mann-Wittney test;     Significance on p<0,05; Intra-assay variation analysis.      Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days;     Manuscript preparation for paper submission: 30 days.   "
146659|NCT01364623|"     The purpose of this study is to assess the bioavailability of total testosterone through     pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2     b) multiple administration TBS-2.      In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG     and estradiol through pharmacokinetic profiles will also be conducted.   "
146660|NCT01364610|"     Gastroesophageal reflux disease (GERD) is a common and potentially debilitating disorder.     Typical symptoms include heartburn and regurgitation of acid tasting substances. GERD is a     chronic disease and in some cases, more alarming symptoms including food sticking in the     esophagus, pain with swallowing, bleeding, anemia and weight loss develop.      In Alberta, upper endoscopy is the first line of investigation accompanied by an ambulatory     24-hour esophageal pH monitoring for patients with symptoms that are unresponsive to     acid-suppressing therapy or who exhibit alarm symptoms.      Current standard of care in Alberta for esophageal pH monitoring first requires an esophageal     manometry test to identify the location of the lower esophageal sphincter followed by the     placement of a thin catheter with one or more pH probes inserted through the nose and taped     in place to the face for 20 -24 hours. The patient wears a small battery powered data logger     and maintains a diary of GERD symptoms and activity. This system enables the recording and     correlation of specific symptoms with reflux episodes over extended periods and provides     direct evidence of GERD. The nasally passed pH catheter is uncomfortable and restrictive for     some patients often resulting in abnormal eating, drinking, activity and sleeping patterns.     The data collected may not be representative of the patient's typical experience and may not     reflect the true severity of the disease.      A wireless diagnostic pH monitoring system called Bravo pH Monitoring System developed by     Medtronic is approved for use in Canada and is commercially available. This system eliminates     the need for a catheter by utilizing a capsule the size of a gel-cap and radio frequency     technology to monitor esophageal pH. It has been shown to be safe and as sensitive as     conventional catheter-based pH probe monitoring. The Bravo system can be sited either     endoscopically or manometrically.      The goal of this study is to test the Bravo Wireless pH system in Alberta using manometric     siting to assess feasibility, patient outcomes and tolerance.      Hypotheses:        1. Patient tolerance of the Bravo system is superior to standard pH-metry.        2. Manometric placement of Bravo is as successful as standard pH-metry.      Our aims:        1. To assess patient tolerance of Bravo versus standard pH-metry.        2. To compare the success rate of manometric peroral placement of Bravo pH probe versus          standard pH-metry.   "
146662|NCT01364584|"     Previous research in our lab and others has established that type 2 diabetes (T2D) is     associated with significantly impaired functional exercise capacity, a factor which is     potentially associated with an increased risk of cardiovascular disease in those with type 2     diabetes. Of great concern, the majority of people with type 2 diabetes are sedentary and one     possible reason may be that exercise, even at low levels, is perceived as being a harder     effort than for nondiabetic people. Thus, treatments that may motivate patients with type 2     diabetes to be more physically active have great potential benefit.      Recent observational studies suggest that glucagon-like peptide-1 agents, such as exenatide,     may have a beneficial effect on endothelial and cardiac function. Because these two factors     have been shown to be associated with exercise dysfunction in type 2 diabetes, the     investigators hypothesize that exenatide may improve exercise capacity in those with type 2     diabetes. The aims of this study are to (1) assess whether exenatide will improve functional     exercise capacity in persons with type 2 diabetes and (2) investigate the effect of exenatide     on specific metabolic, endothelial, cardiac and peripheral circulatory measures of function     related to changes in exercise capacity. The Investigators primary hypothesis is that     exenatide will improve functional exercise capacity in people with type 2 diabetes. Having a     drug that improves exercise capacity could motivate patients to exercise more and hence be a     significant benefit.   "
146663|NCT01364571|"     This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of     three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The     main goal of the study is to determine how safe and well tolerated the vaccine is as well as     to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65     years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence     of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy     adults aged 18 to <65 years.   "
146664|NCT01364558|"     The purpose of this clinical research study is to assess the bioavailability and     pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and     injectable diazepam after intravenous (I.V.) administration   "
146665|NCT01364545|"     Parkinson's disease is a progressive condition that harms nerve cells of the brain     (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep     brain stimulation) improve certain symptoms but are not thought to improve the underlying     neurodegenerative disease process (they are not a cure). The cause of Parkinson's disease     is unknown. However, some evidence suggests that tiny structures in the investigators cells     called mitochondria might be involved. Mitochondria are the powerhouses that produce fuel     for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of     certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a     food called 'ketones' might be able to enhance the function of mitochondria and improve     Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study,     the investigators would like to investigate this possibility by giving patients with     Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators will     then assess if this improves symptoms of Parkinson's disease.      The study design is a prospective, double blinded, randomised, controlled trial.   "
146666|NCT01364532|"     The transradial route is increasingly used as an access site in percutaneous coronary     interventions, as it is considered equivalent to transfemoral approach in terms of efficacy     but with a decreased vascular complication risk. Information concerning the efficacy and     safety of transulnar approach is sparse. This is a prospective, randomized,     investigator-initiated study to compare transradial versus transulnar approach as a default     strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention     (PCI). Consecutive eligible patients with an indication for coronary angiography, will be     randomized after written informed consent in a 1:1 ratio to either transradial or transulnar     access. Assessment of angiographic and procedural characteristics(including amount of     contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular     or other peri-procedural complications of the cases enrolled, will be performed. After     hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound     assessment of the forearm vessels and documentation of major adverse cardiovascular events     (defined as death, myocardial infarction, target vessel revascularization and stroke.     Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500     or 5000 IU of unfractioned heparin.   "
146667|NCT01364519|"     Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled     lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment     of inflammation will be via sputum induction.   "
146668|NCT01364506|"     Objective: To assess the relationship between maternal cardiovascular capacity and aerobic     water exercise during the gestational periods of hemodynamic overload. Study design:     randomized clinical trial, with 41 healthy pregnant women assigned to one of two groups:     Control and Water exercise. Maternal cardiovascular capacity (maximum oxygen consumption,     cardiac output, stroke volume, heart rate and mean arterial pressure), physical performance     (relative HR, treadmill speed and self-perceived exertion) and neonatal outcome (gestational     age, weight, Apgar index and length of infant's hospitalization) were assessed. Means were     evaluated by dependent and independent t-tests, and proportions by the chi-square method     (p<0.05). Results: The control variables showed that the groups were homogeneous. Water     exercise was associated with maintenance of VO2max, increase in stroke volume and cardiac     output, and better performance on stress tests in the third trimester of gestation. No     significant difference in neonatal variables was observed. Conclusion: Water exercise     maintained cardiovascular capacity and performance under submaximal stress, and did not     affect hemodynamic adaptation to gestation or neonatal outcome.   "
146669|NCT01364493|"     Although the overall incidence of gastric cancer has steadily declined in many Western     countries during the last few decades, it is still one of the most common tumors in China. It     is now well recognised that combination chemotherapy regimens improve patient outcomes, but     there is no accepted global standard regimen for advanced gastric cancer.      The ToGA study was the first randomized, prospective, multicenter, phase III trial to show     the efficacy and safety of Trastuzumab in HER2- positive GC. Trastuzumab reduced the risk of     death by 26% (HR 0.74; 95% CI 0∙60, 0∙91; p=0∙0046) when combined with a reference     chemotherapy (Capecitabine plus Cisplatin) and prolonged the median survival by nearly 3     months (from 11.1 to 13.8 months) in patients with HER2-positive(FISH+ or IHC3+) advanced GC.      Oxaliplatin has been shown to be as effective as cisplatin, and exhibits a favorable toxicity     profile with a substantially lower rate of nephrotoxicity, ototoxicity, and myelosuppression.      In the current study, the efficacy and safety of Trastuzumab in combination with     Oxaliplatin/capecitabine chemotherapy will be evaluated in Chinese patients with HER2     positive advanced or recurrent gastric cancer.   "
146670|NCT01364480|"     The purpose of this research study is to demonstrate the safety and efficacy of using two     NeuroPort Arrays (electrodes) for long-term recording of brain activity.   "
146671|NCT01364467|"     This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of     oral guaifenesin for the therapy of Chronic Rhinitis in 36 children between the ages of 7 and     18 years. The study investigates the effectiveness of guaifenesin in the relief of nasal     symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to nasal     airway volume, and biophysical properties of nasal secretion. The investigators hypothesize     that Guaifenesin use over a period of 14 days improves subjective nasal complaints in     pediatric patients with chronic rhinitis and nasal congestion, as measured by the SN-5 survey     compared to use of placebo. There will be an observed improvement in nasal volume and     cross-sectional area following use of guaifenesin, and nasal secretions will have more     favorable mucociliary and sneeze clearability compared to use of placebo.   "
146672|NCT01364454|"     Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence     that it reduces mortality from CRC and that it's cost-effective. In France, there is a     national CRC screening programme inviting people aged 50-74 years by mail to consult their     General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two     years. Participation is a key factor for the screening programs success. High levels of     screening uptake and the continued participation to regular screening must be achieved and     maintained in the targeted population if the enormous potential of CRC screening is to be     realised. Screening rates of various international programs vary widely (20-52%) and the     participation is insufficient in the most settings. Therefore, a better understanding of     facilitating and hindering factors of patient participation can guide interventions to     improve CRC screening rates. They include patients and physicians' factors. One issue is     about GPs practice. GP involvement has been shown to improve the participation in the CRC     screening. This study aims to assess the effectiveness of an intervention targeting GPs to     increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned     to either the intervention group or to usual care (control group) and they will be followed     one year. The intervention consists in providing every four months to the experimental group     a list of their patients who are eligible but did not proceed yet to the screening. In both     groups, patient participation in the screening will be measured at the end of the study.   "
146673|NCT01364441|"     The primary objective of this study is to evaluate the safety and tolerability of ONO-2952     across ascending single doses in healthy adult male and female subjects. The secondary     objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary     objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile     of ONO-2952.   "
146677|NCT01364389|"     The study is a two-week, single-blinded, double-dummy, randomized, active-controlled,     parallel group design, with a follow-up period up to a total study duration of 6-month,     non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare.     It is a multicentric, multinational study. The protocol will seek to enroll a total of 30     patients, who will be randomized to the 3 arms at a ratio of 1:1:1.      Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing     period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after     their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the     case of a disease flare.   "
146678|NCT01364376|"     This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus     5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative     chemotherapy for advanced gastric cancer.      Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric     cancer.   "
146679|NCT01364363|"     The purpose of this study is to provide an opportunity for patients with malignancies or bone     marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic     progenitor cell transplantation using cells from unrelated individuals or cord blood     registries.   "
146680|NCT01364350|"     The purpose of this study is to continue to follow participants in the TODAY clinical trial     as they transition to non-blinded, non-randomized standard diabetes care and management with     monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are     analyzed and findings interpreted to develop a long-term observational protocol (phase 2).     Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.   "
146681|NCT01364337|"     Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given     to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly     prescribed with medications without comprehensive instructions on dietary therapy. DASH diet     has been proven to be an effective dietary approach to reduce blood pressure for hypertension     patients in US. However, dietary difference and patient profiles across countries are     evident. In addition, hypertensive patients are often combined with hyperglycemia.     Carbohydrate burden of DASH diet may be higher than most dietitians desire. Therefore, the     investigators in tend to design a Taiwanese DASH diet and a lower carbohydrate DASH diet and     test their efficacy on both blood pressure and fasting glucose lowering.   "
146682|NCT01364324|"     The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile     of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).   "
146683|NCT01364311|"     Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory     response on the ocular surface. Common symptoms include ocular discomfort, visual impairment     and instability of the tear film with potential damage to the ocular surface.      In addition, an intact tear film is important to provide a smooth optical surface, to act as     a barrier to pathogens, to nourish the epithelial cells of the ocular surface and to prevent     exsiccation. Alterations in the tear film composition, which can have their origin in several     conditions, lead to tear film hyperosmolarity or instability resulting in DES.      Regardless of the cause of DES, chronic dryness of the ocular surface leads to an increased     susceptibility to oxidative stress, which is triggered by reactive oxygen species (ROS). This     results in cell damage and activation of the immune system, keeping up inflammatory processes     . In order to prevent ROS damage, several micronutrients such as vitamin C, E, and certain     carotenoids, omega-3 free fatty acids, flavonoids and minerals have been used because of     their antioxidant capacities.      Based on this knowledge the potential of these antioxidant dietary supplements has been     discussed as a treatment option for DES. Preliminary data support the hypothesis that     antioxidant supplementations, in particular, supplementation with omega 3 fatty acids may be     beneficial for patients with DES.      The purpose of the present study is to test the hypothesis that treatment with dietary     supplements improves subjective and objective symptoms of DES.   "
146684|NCT01364298|"     This is a multicenter, randomized, open-label, parallel, Phase 4 clinical trial to compare     efficacy and safety of gabapentin/B-complex versus pregabalin in diabetic peripheral     neuropathy pain (DPNP) management.   "
146685|NCT01364285|"     The investigators know little about how patients feel following radiosurgery treatment of     trigeminal neuralgia. Patient satisfaction may ultimately be one of the most important     outcome measures for an individual patient; however, this has not been adequately assessed or     followed. Multiple questions remain unanswered, including whether there is a correlation     between patient satisfaction, the level of their current pain score, and the presence and     degree of facial numbness, a possible side effect after radiosurgery. Therefore, the goal of     this study is to gather this information from the patients who received radiosurgery for     trigeminal neuralgia at Stanford and evaluate post-treatment patient satisfaction, the degree     of facial numbness, and current pain score. This data will help the investigators understand     outcomes that are important for patient satisfaction following treatment of a chronic pain     syndrome.   "
146686|NCT01364272|"     Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that     significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has     been shown to provide pain relief in majority of patients treated. However, a common side     effect of radiosurgery is facial numbness. To better understand how radiosurgery can bring     about pain relief and facial numbness, we are conducting a study in which brain MRI scans     will be done following stereotactic radiosurgery to learn if there are any changes in the MRI     scans that correlate with symptoms.   "
146687|NCT01364259|"     Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that     significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has     been shown to provide pain relief in majority of patients treated. However, a common side     effect of radiosurgery is facial numbness. Our goal is to maximize pain control while     minimizing side effects. To this end, the purpose of this study is to evaluate whether adding     a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.   "
146702|NCT01364064|"     This is a Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose Intensive     Temozolomide in Patients with Newly Diagnosed Glioblastoma.   "
146688|NCT01364246|"     Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune     demyelinating disease of the central nervous system, along with a considerable pathological     heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease,     and its clinical characteristics include recurrent optic neuritis and longitudinally     extensive transverse myelitis.      Current therapies provide only modest control of progressive Multiple Sclerosis and     Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an     efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of     Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients     with progressive MS and NMO.   "
146689|NCT01364233|"     Surgically repair of large abdominal hernias requires prosthetic materials such as mesh-like     products. A relatively new synthetic product cPTFE is designed as a cost effective     alternative to reduce associated post surgical complications. The study will monitor patients     over a one year period.   "
146690|NCT01364220|"     It is anticipated that 548 subjects will be recruited from approximately 27 centres in South     Korea.      This is an investigator-sponsored, double-blind, placebo-controlled, randomized, multi-centre     study to assess the effects of rosuvastatin 20 mg compared to placebo in acute ischemic     stroke patients, with the first dose within 18 hours after baseline MRI and continued     treatment for 14 days.      Subjects will be male or female, over 20 years, with diagnosis of acute ischemic stroke with     baseline MRI, and who are either statin-naïve or untreated with statin for the previous 3     months.      The objective would be to compare the recurrence rate of ischemic stroke by comparing the     imaging parameters during 14 days of treatment and clinical improvement as defined by percent     improvement based on NIHSS scores measurements at baseline, 5 days and 14 days of treatment.   "
146691|NCT01364207|"     High intraocular pressure (IOP) is a known risk factor for developing primary open-angle     glaucoma (POAG). There is controversy in the literature regarding the degree to which     caffeine influences IOP, with some studies reporting minimal changes in IOP while others     report up to 4 mmHg increases. To date there are no double-masked randomized controlled     trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for     primary open-angle glaucoma. The investigators aim to better understand the relationship     between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a     double-masked, crossover randomized controlled clinical trial.   "
146692|NCT01364194|"     The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25%     bupivacaine for controlling pain after total knee replacement to improve the quality of     post-operative care.   "
146693|NCT01364181|"     Pulmonary hypertension (PH) is a serious complication of COPD which is associated with     shorter survival, more frequent exacerbation, and increased use of health resources. There is     no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators     wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on     exercise capacity of severe COPD patients.   "
146694|NCT01364168|"     The primary aim of the study is to derive and validate risk scores for vascular endpoints     (recurrent stroke, myocardial infarction, and other complications of stroke) and for death     following an incident stroke. For this purpose patients with an incident stroke will be     followed for 36 months with additional assessments at 3, 12, 24 and 36 months.   "
146695|NCT01364155|"     Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects     on weight in obese and diabetic rodent models. Results from a Phase 1b clinical study,     conducted in healthy volunteers, indicate that LIM-0705 and a major metabolite may be     potential insulin sensitizers by OGTT.   "
146696|NCT01364142|"     One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji     Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice.     We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic     bronchoscopy.   "
146697|NCT01364129|"     This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect     diabetic retinopathy when compared to traditional surveillance methods, 2) identify the     health belief factors related to adherence with annual diabetic eye exams, and 3) determine     the cost-effectiveness of the telemedicine system from the perspective of the community     clinic, the third-party payer, and the individual patient.   "
146698|NCT01364116|"     Measuring total hemoglobin(tHb) is a precious step to decide to start or to stop transfusion     during operation. The newly developed instrument pulse CO-Cooximetry (Masimo) makes     noninvasive monitoring of venous hemoglobin level (SpHb).      The objective of this study        -  to compare the simultaneous level of tHb and SpHb during operation and after volume          expansion in children        -  to assess the accuracy of amount of acute change of SpHb on Masimo and tHb   "
146699|NCT01364103|"     The purpose of this study is to evaluate static and dynamic parameters, echocardiographic     parameters, and pleth variability index for predicting fluid responsiveness in children.     Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate,     central venous pressure, systolic pressure variation, pulse pressure variation, delta down,     aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth     variability index will be measure before and after volume expansion. Patients will be     classified as responders to volume loading if stoke volume index increase by at least 15%.   "
146700|NCT01364090|"     This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and     effective for patients who are current injection drug users or receiving opiate substitution     therapy and who are responding well to treatment early on.   "
146701|NCT01364077|"     A significant association between resting heart rate (HR) and both all-cause mortality and     cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the     general population and for patients with cardiovascular disease.      Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study     reported that the 48-hr mean HR is an independent predictor of cardiovascular events in     normotensive hemodialysis patients.      Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial     antianginal effects and mortality reduction linked to HR reduction in ischemic patients.      Aim:      To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with     increased pre-dialysis HR (> 80 bpm)   "
146703|NCT01364051|"     This phase I trial studies the side effects and best dose of cediranib maleate and     selumetinib in treating patients with solid malignancies. Cediranib maleate and selumetinib     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.     Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the     tumor.   "
146704|NCT01364025|"     Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of     hysterectomy?      The answers to these questions will facilitate the treatment of many American women. With the     results of this study, the investigators would anticipate a reduction in the number of     surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was     shown to be ineffective, it would not be used routinely in the setting of hysterectomy and     women will be spared the additional procedure and possibility of side effects or     complications.      The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at     the time of hysterectomy in women without symptomatic prolapse symptoms have never been     studied prospectively.   "
146705|NCT01364012|"     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety     of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in     participants with advanced or recurrent non-squamous non-small cell lung cancer who have not     received prior chemotherapy for advanced disease. Participants will be randomized to receive     either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) or placebo on Day 1     of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. Anticipated time on     study treatment is until disease progression or unacceptable toxicity occurs. After     progression, participants in the bevacizumab arm may continue to receive bevacizumab in     combination with approved second- and third-line treatment at the discretion of the     investigator, up to the third progression.   "
146706|NCT01363999|"     A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and     atorvastatin from prototype fixed dose combination formulations in healthy volunteers.     Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four     treatment periods.   "
146707|NCT01363986|"     This single-arm, multicenter, open-label study will evaluate the efficacy and safety of     Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in     patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg     (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on     study treatment is 18 weeks.   "
146708|NCT01363973|"     Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke.     Despite its enormous impact on functional capacity, quality of life, and survival, OD is both     underestimated and underdiagnosed as a cause of major nutritional and respiratory     complications in stroke patients. A recent systematic review on the effects of rehabilitation     therapy on OD concluded that although some positive effects were found, the number of studies     was small, many of them had methodological problems and there was a need for further research     using randomized controlled trials. Transcutaneous electrical stimulation was approved by the     FDA as a treatment of dysphagia in June 2001 and is traditionally used to activate pharyngeal     muscles through stimulation of peripheral motor nerves (neuromuscular electrical     estimulation, NMES). However, their real effectiveness and safety in the treatment of     dysphagia is still matter of discussion (Logemann Dysphagia 2007, Ludlow dysphagia 2007) and     studies evaluating NMES therapy, present discordant results. On the other hand, in recent     years, transcutaneous electrical stimulation is beginning to use as a sensory strategy     (Gallas 2010), avoiding muscle contraction during the treatment.Our research strategy     includes the assessment of the therapeutic effect of these two main strategies using     transcutaneous electrical stimulation on swallow physiology and clinical outcomes of     post-stroke dysphagic patients.   "
146709|NCT01363960|"     The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity     screening.   "
146710|NCT01363947|"     Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A     administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to     participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The     study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.   "
146711|NCT01363934|"     This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active     controlled, Dose-escalation Study to investigate the safety, tolerability, and     Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous     Administration in Healthy Male Subjects.   "
146712|NCT01363921|"     The purpose of this study is to determine whether high porous membranes are effective in the     treatment of cardiovascular events in chronic dialysis patients.   "
146713|NCT01363908|"     This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability     of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single     16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which patients will     receive an additional 48 weeks of SSP-004184AQ dosing. Two age groups will be studied: 6-<12,     and 12-<18 years old. The study is designed to initially assess the pharmacokinetics and     safety of SSP-004184AQ in older children (adolescents, 12-<18 years old) and then if deemed     safe, in younger children (6-<12 years old).   "
146714|NCT01363895|"     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, associated with an     increased risk of morbidity and mortality1. The management of AF patients is aimed at     reducing symptoms and at preventing severe complications associated with AF. In the last     years, two new strategies have emerged with different objectives. In the PROTECT AF study2,     percutaneous closure of the Left Atrial Appendage (LAA) with a closure device provided an     alternative strategy to oral anticoagulation for stroke prophylaxis. The AFFIRM trial3 has     shown that drug-based management of AF with a rhythm-control strategy conferred no advantage     over a rate-control strategy in cardiovascular mortality and might be associated with an     increased noncardiovascular death rate4. Catheter ablation has gained a greater place in the     rhythm control strategy, showing superiority in maintaining sinus rhythm in comparison with     AAD5. However, in persistent AF, repeat ablation procedures are necessary in up to 70% of     patients to achieve sinus rhythm at a long-term follow-up6-7.      This prospective, randomized trial will compare the percutaneous closure of the LAA combined     with a rate-control strategy to catheter ablation in the management of patients with     persistent AF. Patients who are eligible for catheter ablation as well as LAA closure device     implantation and are willing to participate in the study will be randomly assigned to     catheter ablation or percutaneous closure of the LAA by a closure device implantation in the     relation 1:1. The primary endpoint of the study is a composite endpoint at 12 months of all     cause death, thrombo-embolic events, major bleeding (BARC type 3), re-hospitalisation and     severe symptoms due to arrhythmias. Secondary endpoints include a composite endpoint of     bleeding, a composite endpoint of thrombo-embolic events, cardio-vascular mortality, total     duration of hospitalisation, sustained discontinued anticoagulation, quality of life     improvement, use of Antiarrhythmic Drugs (AAD), total costs, freedom from arrhythmia and     average ventricular frequency in 7-day holter ECG at 12 months.      The objective of the study is to assess the superiority of percutaneous closure of the LAA     combined with rate-control to catheter ablation in patients with oligosymptomatic AF.   "
146715|NCT01363882|"     Use of noninvasive ventilation (NIV, also known colloquially as Bipap) has been associated     in some studies with improvement in pulmonary function, quality of life and survival. NIV is     typically applied during sleep, and without the benefit of sleep study to determine the     optimal settings. The investigators have shown that when NIV is used in this fashion, failure     of nocturnal oxygenation and ventilation is prominent. This study is randomizing patients to     standard application of NIV vs application guided by use of sleep study data to determine the     effect of titrated therapy on pulmonary function, quality of life and survival.   "
146716|NCT01363869|"     Green tea has been extensively investigated for several potential health benefits. Previous     studies have suggested that green tea may lower serum uric acid level in human. The purpose     of this study is to investigate uric-lowering properties of green tea in healthy individuals.   "
146717|NCT01363856|"     The primary aim of the study is to derive and validate risk scores for vascular endpoints     (recurrent stroke, myocardial infarction, and other complications of stroke) and for death     following an incident stroke. For this purpose patients with an incident stroke will be     followed for 36 months with additional assessments at 12, 24 and 36 months.   "
146718|NCT01363843|"     The purpose of this study is to find out how well patients with cancer of the rectum do if     they get all of their other treatment - chemotherapy by itself followed by chemotherapy and     radiation together - before surgery. Patients have recently been diagnosed with rectal     cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the     cancer before removing it.   "
146719|NCT01363830|"     Post-operative restrictions following lumbar discectomy is a controversial topic. While the     most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks     following discectomy, a number of studies support an early return to full activity without     restriction. Since the goal of discectomy is to promptly provide pain relief and a return to     a fully active lifestyle, perhaps post-operative restrictions are more hindering than     beneficial.      Hypothesis: Post-operative restrictions following lumbar discectomy do not influence     reherniation rate.      Specific Aim 1: To compare the reherniation rates between the 6-weeks of restriction and the     2-weeks of restriction groups.      Specific Aim 2: To determine the return to full activity and return to work dates of both the     6-weeks of restriction and 2-weeks of restriction groups.      Specific Aim 3: To assess the health outcomes of both the 6-weeks of restriction and 2-weeks     of restriction groups.   "
146720|NCT01363817|"     The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either     alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic     leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from     standard therapies   "
146721|NCT01363804|"     This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile     of tivozanib.   "
146722|NCT01363791|"     Diabetes and heart associations continue to discourage high intakes of dietary fructose, a     constituent part of the sucrose molecule that is found in fruits and vegetables as a natural     sugar and in some processed foods and beverages as an added sweetener. The concern relates to     its ability to increase certain blood fats and cholesterol, which increase the risk of     cardiovascular disease. The evidence for an adverse effect of fructose on these risk factors,     however, is inconclusive. To improve the evidence on which nutrition recommendations for     fructose are based, the investigators therefore propose to study the effect of fructose on     blood fats, cholesterol, sugars, blood pressure, and body weight, by undertaking a systematic     synthesis of the data taken from all available clinical studies in humans. This technique has     the strength of allowing all of the available data to be pooled together and differences to     be explored in groups of different study participants (healthy humans of different sex,     weight, and age and in those with diseases which predispose to disturbances in metabolism,     such as diabetes) with dietary fructose in different forms, doses, and with differing     durations of exposure. The findings generated by this proposed knowledge synthesis will help     improve the health of consumers through informing recommendations for the general public, as     well as those at risk of diabetes and cardiovascular disease.   "
146723|NCT01363778|"     This study is designed to evaluate the effect ketoconazole on the Pharmacokinetic profile of     tivozanib.   "
146724|NCT01363765|"     Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and     inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of     sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4     to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique,     named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in     addition to identification of cases resistant to certain drugs used to treat TB. The test is     expensive, but several studies have demonstrated its accuracy, and since most steps are     automatized, savings can be expected from human resources work. The aims of our study are (1)     to evaluate this tool as a substitute test for sputum smears in routine conditions; (2)     evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the     extra cost, and (3) evaluate the acceptability of the test among patients and health care     workers.   "
146725|NCT01363752|"     The purpose of this study is to compare the effect of two anti-rejection therapy regimens on     kidney function in kidney transplant recipients.   "
146726|NCT01363739|"     -1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a     role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of     metastatic colorectal cancer patients. The present study aims to prospectively evaluate the     predictive role of this polymorphism in metastatic colorectal patients receiving the same     treatment.   "
146727|NCT01363726|"     The purpose of this study is to monitor diarrheal disease and observe changes after the     introduction of the rota vaccine.   "
146728|NCT01363713|"     Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic     conjunctivitis, in an open-label, multicenter study.   "
146729|NCT01363700|"     The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution     compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients     with allergic conjunctivitis.   "
146731|NCT01363674|"     This is a National, Multicentre, Observational Registry to study adherence and long term     outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth     hormone treatment from hospitals in Greece and to assess the level of adherence of subjects     receiving SAIZEN® via Easypod™.   "
146732|NCT01363661|"     Molsidomine used as an add-on treatment on standard care therapy should be superior to     placebo used also as an add-on treatment on standard care therapy on improving the     endothelial function (endothelium score measured by reactive hyperemia - peripheral arterial     tonometry [RH-PAT]) after 12 months of treatment in patients with stable angina patients and     undergoing elective percutaneous coronary intervention.      The study will be double-blind, parallel-group, randomised, multicentre, sequential,     placebo-controlled study.      The device used to determine RH-PAT will be EndoPAT. Duration of the treatment = one year.   "
146733|NCT01363648|"     To date, there are no approved treatments for vascular cognitive impairment (VCI) and the     main therapeutic efforts are aimed at controlling vascular risk factors for countering VCI     development or progression. Several studies have reported cholinergic deficits in brain and     cerebrospinal fluid of patients with VCI. The effect of choline alphoscerate in clinical     studies of Alzheimer's disease and VCI improved memory and attention impairments. The purpose     of our study is to determine effectiveness of choline alphoscerate vs placebo in improving     cognition in post-stroke patients with VCI-non dementia (VCI-ND).   "
146734|NCT01363635|"     Severe sepsis/septic shock are serious complications of infection with high morbidity and     mortality. Recent information showed that early and aggressive resuscitation with goal     directed therapy help improving survival and outcome especially the resuscitation within the     first 6 hours. In surgical patients, either severe sepsis/septic shock bought them to the     operating room or this sepsis might be found after surgery resulting in higher morbidity and     mortality. Not only knowledge management, others possible risk factors should also be     identified and corrected for outcome improving. This prospective observational study will be     done in 800 adult surgical patients admitting to the general surgical intensive care unit.     Incidence of severe sepsis/septic shock on admission along with risk factors associated with     poor outcomes [organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length of,     stay, ICU death] will be recorded especially effect of amount and type of fluid replacement     in the first 6 hours, 24, 48 and 72 hours after diagnosis. Knowledge about severe     sepsis/septic shock was implemented among the associated personal, outcome as major organ     failure, ICU length of stay, ICU death will also be compare between this prospective study     and historical controlled.   "
146735|NCT01363622|"     The aim of this study was to investigate circulating concentrations of vaspin in fetal and     neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum     vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA     singleton full-term fetuses and neonates on cord blood and postnatal day 5.   "
146736|NCT01363609|"     The aim of this study is to investigate if endogenous Glucagon Like Peptide -1 (GLP-1) has an     effect on brain satiety and reward systems and if there are alterations in obese patients     with type 2 diabetes (T2DM). Secondly, the aim is to investigate whether treatment with a     GLP-1 analog, liraglutide, restores these signals in obese patients with type 2 diabetes.     Finally, also the endogenous GLP-1 effects will be investigated in obese individuals before     and after gastric bypass surgery on brain satiety and reward systems.   "
146737|NCT01363596|"     NaProTechnology (NPT) is a treatment option for infertility or miscarriage that identifies     issues in a couple's fertility and fixes them to the extent possible by medical intervention.     An important part of NPT is teaching couples to monitor the signs and symptoms of the woman's     fertility cycle (menstrual cycle) with the Creighton Model FertilityCare System (CrMS).      The purpose of the study is to look at outcomes among couples who consider or get NPT     treatment to help them have a live birth. Results from the study will be used to answer     questions such as:      How many couples who use NPT get pregnant and have a baby? How can NPT treatment be improved?     Does NPT treatment have fewer long-term health risks for the resulting children than other     fertility treatments? What types of characteristics or environmental exposures influence     whether NPT will be successful for a specific couple?      To be eligible for the iNEST study, a couple must have a consultation with a NPT-trained     clinician who is participating in iNEST.   "
146738|NCT01363583|"     This study is a prospective consecutive double-blinded randomized study on the effect of     PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe     traumatic brain injury. All patients with severe traumatic brain injury were eligible for     inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at     intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure     (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma.      Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a     lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.      A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers,     measured by different cytokines.   "
146751|NCT01363414|"     Eyes with abnormal tear film function have been found to show larger optical aberrations than     normal eyes which may be attributed to the unstable and irregular tear film, uneven ocular     surface, and increased scatter due to the exposure of the rough surface of corneal epithelium     after tear break-up.      These hypotheses have been supported by the findings that instillation of artificial tears     (sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular     aberrations, improving the optical quality of the retinal image.      However, the previous studies only evaluated the short-term effects of a single     administration of an artificial tear but did not determine the duration of action or     inflection point at which the ocular aberrations increase back to baseline. Also, there has     clearly been no such clinical trial that has been a well randomized controlled study to date.      This report is the first randomized controlled trial that investigated the long-term effects     of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in     patients with dry eye.   "
146854|NCT01362062|"     This observational study will evaluate the safety, tolerability and efficacy of tocilizumab     in participants with moderate to severe RA who have an inadequate response to current     non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant     during tocilizumab therapy and on follow-up for a total of 12 months.   "
146739|NCT01363570|"     Age Related Macular Degeneration (AMD) is the leading cause of blindness in North America.     This condition causes a progressive loss of central vision, the part of your vision that     allows you to read, drive and see images in sharp detail directly in front of you. The wet     form of AMD is characterized by the growth and leakage of small blood vessels into the     choroid layer of the eye, or the back of the eye. These leaking blood vessels disrupt the     structure and function of the eye, causing loss of vision, particularly the sharp vision     created by the macula area of the eye.      Currently, the best treatment for wet AMD is a series of injections of an anti-vascular     endothelial growth factor (anti-VEGF) drug, ranibizumab (Lucentis). The clinical response to     treatment is varied. Approximately 70% of patients see a moderate vision gain (3-line gain on     a visual acuity chart), but there are 30% who do not see a similar improvement in vision.     There is no way to identify those patients who will respond with significant vision gain     versus those who will not experience moderate vision gain. Recent research into AMD has     demonstrated that genetic mutations are proving to be key risk factors for patients     developing wet AMD, with up to 80% of wet AMD cases explained by inherited genetic     variations. Scientists have theorized that there may be a genetic difference between those     patients who see significant responses to treatment and those who do not. The investigators     will be testing participant's genetic profile using the Macula Risk test and following their     progress through the standard treatment for wet AMD over the course of this study. This study     aims to demonstrate the association between known genetic variations and patient responses to     treatment.   "
146740|NCT01363557|"     Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in     addition to Gefitinib for the management of brain metastasis in lung cancer patients with a     mutated EGFR.   "
146741|NCT01363544|"     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that has a severe     impact on a child's life and society. The core symptoms are attention problems, hyperactivity     and impulsivity. These symptoms are related to disruptions in neurocognitive functions (such     as inhibition: the ability to stop behavior) and disruptions in cortical regulation (such as     'cortical underarousal' as measured with the electroencephalogram). To date, the only     evidence-based treatment is pharmacological. Medication is not effective in 20-30% of the     children with ADHD and it can have side effects. The lack of alternatives for medication is a     severe problem for these children and society.      Neurofeedback is becoming increasingly popular for treating ADHD. Neurofeedback is a training     in which a person learns to alter its cortical regulation. Neurofeedback has been classified     as 'probably effective' but its treatment effects need further empirical evidence. Non     specific training effects, such as individual attention, may also contribute to treatment     success. In this research project the investigators compare the efficacy of neurofeedback     with exercise, a second non-pharmacological treatment, that may be comparable with     neurofeedback in terms of non-specific effects. Exercise is also a promising treatment     because of its positive effects on behavior, neurocognition in several patient groups. For     these reasons, exercise deserves systematic research in ADHD. Furthermore, the investigators     compare the efficacy of these two treatments with an optimal pharmacological treatment with     methylphenidate (MPH). The main question is if neurofeedback and exercise are comparable in     efficacy with MPH for treating ADHD. The primary outcome measure is behaviour (symptoms of     ADHD). Secondary outcome measures include neurocognition and cortical regulation. This     research project will give answer to the question if neurofeedback and exercise are as     effective as MPH. Furthermore, it will give insight in how these interventions will give rise     to improvements in behavior.   "
146742|NCT01363531|"     The general hypothesis is that delayed antibiotic treatment strategies present similar     effectiveness, when compared with non-prescription of antibiotics or the prescription of     antibiotics, in the non-complicated acute respiratory tract infections.   "
146743|NCT01363518|"     The subject's broken humerus (arm) is suitable for treatment with a fracture brace or     operative fixation with plate and screws. Both of these types of treatments are often used by     doctors to fix broken bones. If the subject agrees to participate in this study, the subject     will be assigned by the treating surgeon to one of the following groups:      Group B: Non-operative treatment with a fracture brace Group P: a plate & screws - a metal     device placed on top of the bone.      The investigators will collect information about the subject's arm fracture as it is treated     with examinations and X-rays. X-rays will be obtained often in the first several months,     depending on how the fracture is healing. This is determined by the doctor and will not be     determined by the subject's participation in this research study.      Both treatments are routinely used and this study hopes to provide information regarding each     type of treatment on the subject's functional outcome. A subject's treatment will not be     affected whether they choose to participate in this research study or not.      The treatment of these subjects is no different because of this study. The treating surgeon     will discuss with the patient their preferred treatment for the isolated humeral shaft     fracture. If they meet the inclusion/exclusion criteria, they will be approached for     participation in one of two treatment groups depending on a previous decision by the patient     and the treating surgeon.      Hypotheses:        1. Patients with an isolated humeral shaft fracture that are plated will have a more rapid          return to ADL's, work and full functional capacity than patients treated conservatively.        2. Patients treated with plate technique will have a more rapid improvement in functional          outcome scores, decreased pain scores and patient satisfaction than those managed          conservatively.        3. Complication rates of infection and iatrogenic neurologic injury will be higher in          patients treated operatively.        4. Nonunion and malunion will be higher in patients managed conservatively.   "
146744|NCT01363505|"     Studies have shown that more than 30% of the overall acute decompensated heart failure (ADHF)     patients develop renal dysfunction.      Several studies have tried to find a correlation between hemodynamic Parameters (blood     pressure , heart rate, central venous pressure CVP) and worsening of renal function in acute     decompensated heart failure patients.      Results showed that there were no correlation between baseline hemodynamics or change in     hemodynamics and worsening of renal function.      Another study showed that intra-abdominal pressure (IAP) measuring was a better corollary to     renal failure status then measuring cardiovascular hemodynamics using pulmonary artery     catheterization in ADHF patients.. An increased IAP was associated with worse renal function     and that level of IAP far below abdominal compartment syndrome may adversely affect renal     function in patients with ADHF.   "
146745|NCT01363492|"     The purpose of this study is to assess the safety of Replagal in children with Fabry disease     who who have not previously been treated with enzyme replacement therapy (ERT).   "
146746|NCT01363479|"     PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of     palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic     drug), both given with oral dexamethasone. The objective of the study is to demonstrate that     oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to     prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24     hours after administration of a single cycle of highly emetogenic chemotherapy.   "
146747|NCT01363466|"     GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional     relapse, especially in patient with a reduced metastatic risk and who received a local     chemoradiation therapy with an increase of radiotherapy doses (45 grays).   "
146748|NCT01363453|"     The aim of the non-interventional study is to document the daily doses in acute and remission     therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are     added and, when and how long steroids are given.   "
146749|NCT01363440|"     The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection     (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early     treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema     (DME) with central involvement.   "
146752|NCT01363401|"     The purpose of this study is to evaluate the safety and efficacy of autologous bone     marrow-derived stem cells(HYNR-CS inj), through intrathecal delivery for the treatment in     patients with ALS.      This study consists of 2 steps. First step is a safety study of the intrathecal(IT) injection     of HYNR-CS inj in 8 patients with ALS. In this phase 1 study, AE, laboratory test, physical     examination, vital signs, Electrocardiogram, and Chest X-Ray examination were evaluated in     terms of safety.      Second step is to compare the efficacy and safety between test group and control group of     total 64 patients with ALS.   "
146753|NCT01363388|"     The aim of this trial is to optimize the treatment to induce remission for patients with     non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to     reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating     entirely the use of systemic corticosteroids during the induction period with an inhibitor of     the complement C5a receptor plus cyclophosphamide or rituximab.   "
146754|NCT01363375|"     Excessive repetitive loading concentrating upon plantar fascia is considered as the most     influential factor in plantar fasciitis development. Abnormal foot structure may lead to high     risk of plantar fasciitis. However, the biomechanical factor that may cause plantar fasciitis     has not been thoroughly investigated. Orthotic device is a common treatment used for plantar     fasciitis. However, there is no direct and quantitative data, such as stress and strain     distribution of plantar fascia for patient with foot orthosis during gait. Therefore, the aim     of this three-year project study is to investigate the biomechanical mechanism of different     foot structures and to understand the biomechanical response of plantar fascia during stance     phase of gait cycle by dynamic finite element analysis, gait analysis as well as plantar     pressure measurement. In addition, the efficacy of foot orthoses will be evaluated by the     same research process. The hypotheses are that flat foot and high arch foot may result in     higher stress and strain upon plantar fascia during gait; the foot orthosis, such as total     contact insole, carbon fiber plate and rocker bottom sole, would reduce stress and strain     distribution around the calcaneal medial tuberosity; rigid and curved geometric bottom will     be able to relief plantar fascia stretching during push-off phase.   "
146755|NCT01363362|"     Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma     patients. This study investigates, if there are changes in different ocular hemodynamic     parameters prior and after SLT.   "
146756|NCT01363349|"     This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the     cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy     endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints     will occur after 12 and 24 weeks of treatment.      Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study     will utilize a flexible dose escalation scheme designed to allow patients to titrate to their     maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of     35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg     daily). To ensure effective blinding across all treatment groups, all patients will be     treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design).   "
146757|NCT01363336|"     This study is a post-marketing surveillance in Japan, and it is a local prospective, company     sponsored and observational study of patient who have been treated by Adalat CR for     hypertension with diabetes and/or chronic kidney disease. The objective of this study is to     assess safety and efficacy profile of using Adalat CR in real clinical practice. A total     2,000 patients will be recruited and be observed for 6 months. Then, patient of whom     microalbumin urea and serum creatinine are continuously monitored are additionally followed     for 6 months.   "
146758|NCT01363323|"     This study will employ a single-center, randomized, double-blind parallel-group design for     MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm     methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained     after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to     placebo.   "
146759|NCT01363310|"     Most individuals with major depressive disorder manifest clinically significant agitation.     Concurrent agitation in a depressed individual is associated with an intensification of mood     symptoms, decreased probability of recovery, increased recurrence risk, suicidality, and     increased medical-service utilization. The occurrence of anxiety/agitation phenomenology in     the depressed patient often invites the need for augmentation strategies (e.g. atypical     antipsychotics, benzodiazepines, etc.) and complicated polypharmacy regimens. Moreover,     individuals with major depressive disorder often report worsening of symptom severity,     irritability, hostility, dysphoria, and significant subjective distress (This response     pattern is similar to individuals with bipolar disorder).      Results from large research studies provide evidence indicating that quetiapine is capable of     offering clinically significant multidimensional symptom relief in bipolar depression.     Moreover, results from several trials in major depressive disorder and generalized anxiety     disorder have established the efficacy of quetiapine therapy for unipolar depression and     anxiety syndromes. So far, no atypical antipsychotic agent has been evaluated specifically     for the treatment of agitated depression.      In this study, it is hypothesized that persons with major depressive disorder and prominent     agitation (i.e. agitated depression) will exhibit a more favourable response and tolerability     profile to quetiapine XR when compared to escitalopram.   "
146760|NCT01363297|"     The Phase 1 portion of this study will assess the safety, tolerability and efficacy at     increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or     refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2     dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of     inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in     second or later salvage status.   "
146761|NCT01363284|"     The purpose of this study is to identify, prior to prescribing, which neuropathic pain     patients will benefit from duloxetine more specific the investigators aims are to:        -  Verify whether presence of chronic pain alters the pain modulation mechanisms, such as          DNIC (diffuse noxious inhibitory control) and TS (temporal summation).        -  Investigate whether anti-neuropathic medications such as duloxetine indeed change the          pain modulation profile, and whether this profile change is associated with a reduction          of clinical pain.   "
146762|NCT01363271|"     This is a retrospective, observational, non-interventional drug study using de-identified     data from two administrative claims datasets. The study design and analysis will reflect the     perspective of the commercially insured. The objectives of this study are twofold:        1. To compare the rates of re-hospitalization among patients treated with either linezolid          orally or IV, or vancomycin IV for complicated skin and skin structure infections          (cSSSI) or pneumonia hospitalization.        2. To compare the total direct medical costs of patients treated with linezolid orally or          IV, or vancomycin IV for cSSSI or pneumonia hospitalization.   "
146763|NCT01363258|"     The main purpose of this study is to test a method of providing mouth care to persons with     dementia who live in nursing homes. The method of providing mouth care is designed to reduce     fear in persons with dementia, so that these persons do not resist mouth care.   "
146764|NCT01363245|"     The investigators plan to compare the effectiveness and cost effectiveness of an inpatient     smoking cessation intervention for all smokers hospitalized at two urban public hospitals.   "
146765|NCT01363232|"     This is an open label, dose finding, phase Ib clinical trial to determine the maximum     tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered     phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2     inhibitor MEK162. This combination will be explored in patients with epidermal growth factor     receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR     inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal     cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or     BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with     overdose control. At MTD or RP2D, two expansion arms will be opened in order to further     assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.      Study drugs will be administered once daily orally on a continuous schedule. A treatment     cycle is defined as 28 days.   "
146766|NCT01363206|"     The study is an open-label, single arm single Center Phase II study to evaluate the safety     and efficacy of the combination of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF,     Leukine) and Ipilimumab (Yervoy) as therapy for patients with unresectable metastatic     malignant melanoma.   "
146767|NCT01363193|"     Standard weight-based IV heparin for normal weight patients is based on actual body weight     (ABW). However, no well-defined guidelines have been established for patients considered to     be obese or morbidly obese. In current practice, the calculated ABW based heparin initial     bolus dose and infusion rates are quite high, and therefore often not used for obese/morbidly     obese patients for fear of bleeding.      Heparin is distributed in the body approximately the same as blood and does not get     distributed to adipose tissue. There are some studies suggesting that lean body weight (LBW)     might be a better basis for dosing heparin. LBW is a calculated weight that excludes the     weight of fat.      The investigators hypothesize that intravenous heparin dosing based on the Lean body weight     of obese/morbidly obese patients would be safe and effective in achieving a therapeutic level     of heparin in 24 hours compared to the usual practice in this patient population.   "
146768|NCT01363180|"     This project is the first to use a clinical laboratory method in emerging adults to test the     hypothesis that a trauma history with or without concommitant posttraumatic stress disorder     (PTSD) alters response to a stressor and promotes drinking compared to normal controls. The     study will be the first to explore whether trauma-exposed (TE) and PTSD groups differ on     these outcomes. It will also examine the relationship between stress reactivity and     subsequent stress-induced drinking in these samples. The goal of this program is to better     understand the relationship between stress and factors related to the development and     maintenance of alcohol problems in early adults, so that ultimately, better treatments may be     developed that reduce the incidence and severity of alcohol related problems.   "
146769|NCT01363167|"     This study is to determine the amount of vitamin D required for a very low birth weight     infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.   "
146770|NCT01363154|"     The purpose of this clinical trial is to examine the effect of non-invasive cortical     activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two     Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has     indicated that such evoked activity (i.e. by specific music) can result in significant     reductions, or even complete termination of epileptiform activity and/or seizures across a     broad range of individuals with epilepsy. A hypothesis is generated that specific music     activation would beneficially effect photoparoxysmal based epileptiform abnormalities.   "
146771|NCT01363141|"     The investigators have previously demonstrated that Advanced Glycation End products (AGEs)     are associated with several chronic diseases in humans and that blood AGE levels can be     significantly reduced by simply changing the way food is cooked.      This is an interventional-randomized study in which we are trying to determine whether a diet     low in AGE followed for 1 year can effectively reduce circulating AGE levels as well as     markers of the metabolic syndrome in a group of patients with these abnormal markers.   "
146772|NCT01363128|"     The goal of this clinical research study is to learn if ofatumumab combined with standard     chemotherapy can help to control ALL. The safety of these drug combinations will also be     studied.   "
146773|NCT01363115|"     The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D)     supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese     adults.   "
146774|NCT01363102|"     The investigators hypothesize that by applying a validated algorithm to accomplish early     mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a     higher level of mobility which translates to shorter ICU length of stay and improved     functional status at discharge. Additionally, the investigators hypothesize that genetic     polymorphisms related to muscle strength and sleep will also explain some variance in these     outcome variables.   "
146787|NCT01362933|"     Treatment of venous thromboembolism in cancer patients is specific and has been validated in     trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K     Antagonist) treatment during 6 months. International recommendations have diffused this     option.It is necessary to evaluate the compliance of physicians to this treatment by     measuring the number of patients with cancer treated with long term use of LMWH.   "
146775|NCT01363089|"     This was an open label, two way crossover study in healthy male subjects. Two treatments were     administered to each subject, one treatment per study period, in a randomized manner.     Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning     of Day 2 of each period and there was a washout period of at least 2 days between treatments.     A post study medical examination was performed prior to discharge in Period 2.      The objective of this study was to assess the effects of a single dose of intranasal     oxymetazoline hydrochloride on the pharmacokinetics of intranasal ketorolac in healthy male     subjects.   "
146776|NCT01363076|"     This was an open-label PK study in pediatric subjects who had undergone general surgery. Each     subject's study participation consisted of a screening visit, a single-dose treatment with     intranasal ketorolac (IN) tromethamine, and a follow-up visit.      Following surgery, subjects received IN ketorolac 15 mg (weight < 50 kg) or 30 mg (weight >     or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the     subjects had access to an opioid analgesic administered by patient-controlled analgesia     (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points     following the dose of ketorolac.   "
146777|NCT01363063|"     This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each     subject participated in only one part of the study. In Part A subjects received one dose of     15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril     and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the     other nostril, in a randomized manner. In Part B subjects were randomized to receive a single     intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into     one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine     containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study,     subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a     post-study medical was performed prior to discharge.      The objective of this study was to compare the tolerability of formulations of ketorolac     tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A     and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy     volunteers.   "
146778|NCT01363050|"     This was a phase 1, open label, multiple dose study in healthy male and female volunteers.     Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for     three days (seven doses in total). Doses were administered every eight hours.      The objective of this study in healthy volunteers was to determine the safety, tolerability,     and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.   "
146779|NCT01363037|"     The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and     maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by     healthy women in the United States.   "
146780|NCT01363024|"     This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability     and Pharmacokinetics of MGFR1877S.   "
146781|NCT01363011|"     This study is to characterize the effect of cobicistat-based regimens on parameters of renal     function in participants with HIV infection and who have mild to moderate renal impairment,     and to assess the safety and tolerability of the regimens in order to generate appropriate     dosing recommendations.   "
146782|NCT01362998|"     For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot     epidural preservative free morphine with a continuous epidural fentanyl infusion. The     investigators will be comparing the patient's pain level and satisfaction with the two     techniques, as well as the side effects that the patients experience, such as itching,     nausea, back pain and respiratory depression.   "
146783|NCT01362985|"     Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the     European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of     plerixafor will be collected for data entered over a 5 year time span (i.e., data entered     into the registry between the date of European Union (EU) marketing authorization [31 July     2009] and 31 July 2014).      The EBMT is a non-profit, scientific society representing more than 600 transplant centers     mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation     or cellular therapy, which includes registering all the activity relating to stem cell     transplants. Data are entered, managed, and maintained in a central database with internet     access; each EBMT center is represented in this database.      The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor     shall provide information of a substantial number of patients who are representative of the     patient population receiving plerixafor off-label.   "
146784|NCT01362972|"     In the European Union (EU), plerixafor is indicated in combination with granulocyte colony     stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells (HSCs) to the     peripheral blood (PB) for collection and subsequent autologous transplantation in patients     with lymphoma and multiple myeloma (MM) whose cells mobilise poorly.      This is a clinical outcome analysis of a prospectively defined cohort of patients with data     reported retrospectively to the European Group for Blood and Marrow Transplantation (EBMT)     who have lymphoma or multiple myeloma (MM), whose cells mobilize poorly, and who have     undergone autologous haematopoietic stem cell (HSC) transplantation during the years 2008 up     to and including 2012.      The EBMT is a non-profit, scientific society representing more than 600 transplant centers     mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation     or cellular therapy, which includes registering all the activity relating to stem cell     transplants. Data are entered, managed, and maintained in a central database with internet     access; each EBMT center is represented in this database.      The analysis of data from a well established registry like the EBMT registry allows for     follow up of a large number of patients who are representative of the patient population     receiving plerixafor.   "
146785|NCT01362959|"     The purpose of this study is to determine whether transdermal nicotine replacement therapy is     safe and effective for treating nicotine withdrawal symptoms in the critically ill smoking     patient.   "
146786|NCT01362946|"     The purpose of this study is to modify behavior therapy so that it is optimized for children     with conduct problems and callous-unemotional traits by emphasizing reward components and     de-emphasizing punishment components.   "
146788|NCT01362920|"     In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with     other laboratory markers to aid in the risk assessment of critically ill patients with severe     infection (sepsis). Although considerable literature exists regarding the usefulness of     Procalcitonin (PCT) as a marker of sepsis, there are still potential uses for PCT     measurements that are not yet explored and its value among the critically ill patients     remains unclear. This study seeks to better understand the usefulness of measuring PCT values     in patients admitted to the Medical ICU for a variety of reasons and in particular with     severe infection (sepsis).   "
146789|NCT01362907|"     The purpose of this trial was to compare the performance of an investigational daily     disposable contact lens to a commercially available daily disposable contact lens.   "
146790|NCT01362894|"     The purpose of this trial was to compare the performance of two contact lenses commercially     available for people with astigmatism.   "
146792|NCT01362868|"     The purpose of this study is to investigate the investigational device capacity to detect an     intraocular pressure increase (IOP)induced by water intake.   "
146793|NCT01362855|"     The purpose of the study is to inform decision-makers of the best strategies to implement     advanced care planning (ACP).      An advanced care plan (ACP) is a verbal or written instruction describing what kind of care     an individual would want (or not want)if they are no longer able speak for themselves to make     health care decisions.   "
146794|NCT01362842|"     The lung cancer is the most has the life minacity in all kinds of cancers, and it also     remains the most common cause of cancer-related death in the world. The group of lung cancer     patients are suffer from huge disease impact that came from high mortality. Not only the     course of treatment that patients has been diagnosis through operation is more faster, but     also those who could be capable of operated are stabilized to keep follow-up at out-patient     clinic. But in the next following five years after operation, they may take different     dysfunctional level or some kinds of symptom distress. The effect has a great influence on     those patients that have to face extended emotional impact, symptom distress and life style     change. In addition, most of them concern about recurrent all the time in the remission.     These situation needs us to place importance on it.      The purposes of this study are to investigate psychological and physical distress and care     needs in operable lung cancer patients receiving surgery. This survey includes two parts of     physical and mental condition. First, the investigators are scoring their symptom severity     and quality of life to check physical condition. Seconded, the mental condition will use     validated questionnaires to realize the relationship of anxiety, depression, uncertainty,     fear of recurrence, self-efficacy and needs. Final, compare all of the data to patients'     needs.      This study is a cross-sectional designs with convenience sampling that conform to the     investigators recruited requirements. The investigators will recruit from the clinic of     thoracic surgery in one medical center in Taipei and take five structured requirements. And     the investigators are going to collect data from January, 2011 to December, 2012. Also expect     results are lung cancer outpatients after surgery that more physical dysfunction or more     depress of mental condition, it will lead patients' needs increased or significant     difference. In conclusion, this study analyzes their needs in the remission that consequences     can be medical professionals' reference material.   "
146795|NCT01362829|"     The investigators perform a prospective observation study to search for the outcome     predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.   "
146796|NCT01362816|"     The rising incidence of cancer and the rapidly increasing number of people living longer with     incurable disease, accentuates the need for optimal symptom management throughout the disease     trajectory. Thanks to the medical and technological development, and the increased interest     in palliative care research, palliative medicine has gradually become more evidence based.     Patients with advanced cancer experience multiple symptoms at the time with fluctuating     intensity and severity. Pain, fatigue, nausea/vomiting, dyspnea, loss of appetite and     depression are among the most common and experienced by more than 50%. However, the     prevalence rates of these symptoms vary considerably across studies, with a range from 35 to     90 % for pain as an example. These differences may in part be explained by different     assessment tools, study methods and design and population characteristics. There is also lack     of agreed-upon, common criteria to describe the main characteristics of a palliative care     cancer population and few standardized tools for assessment and classification of symptoms     exist. These shortcomings limit the possibility to design randomized controlled treatment     trials in palliative care; the optimal way to improve clinical symptom management. To do     this, a better understanding of how symptoms evolve and how they should be assessed and     classified throughout the palliative care disease trajectory is important, supplemented with     registrations of the treatment provided. The primary aim of this international research     project the European Palliative Care Cancer Symptom study (EPCCS) is to extend the knowledge     about and gain new insight in the prevalence and development of the most frequent cancer     related symptoms during the course of disease, in a large sample of palliative care cancer     patients. The clinical usefulness of the new assessment and classification system developed     by the European Palliative Care Research Collaborative (EPCRC) / European Association for     Palliative Care Research Network (EAPC RN) will be examined and data on the organization and     delivery of palliative care at participating centers will be collected. The project also aims     to further develop and consolidate international research collaboration through the European     Palliative Care Research Centre (PRC). Taken together, these efforts will increase the     understanding of the palliative disease trajectory and provide necessary knowledge and     structure for future randomized controlled trials (RCTs)   "
146808|NCT01362660|"     This study will examine post-natal neurologic and cognitive development of infants who may     have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program     (whether the exposure is through maternal or paternal participation in a tanezumab clinical     study).   "
146900|NCT01361698|"     The aim of this trial is to evaluate the effectiveness of the Illness Management and Recovery     program for people diagnosed with schizophrenia or bipolar disorder in according to their     level of functioning.   "
146901|NCT01361685|"     Lead survivability will be summarized.   "
146902|NCT01361672|"     Lead survivability will be summarized.   "
146797|NCT01362803|"     Background:      - Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat     them is with surgery. Some of these tumors cannot be completely removed. The tumors may be     too large, too numerous, or in a bad location for surgery. An experimental drug called     AZD6244 hydrogen sulfate may be able to prevent the tumors from growing, slow down their     growth, or shrink them. This drug has been tested in adults with cancer and in children with     some types of brain cancer. This study will test how well this drug works with these types of     tumors.      Objectives:      - To study the safety and effectiveness of AZD6244 hydrogen sulfate in children and young     adults with plexiform neurofibromas that cannot be completely removed by surgery.      Eligibility:      - Children and young adults between 12 and 18 years of age who have plexiform neurofibromas     that cannot be completely removed by surgery.      Design:        -  Patients will be screened with a physical exam, medical history, blood tests, and          imaging studies.        -  They will take the study drug twice a day with 8 ounces of water, every day for 28-day          cycles of treatment. During study visits, participants will have blood and urine tests          and physical exams. They will also have imaging studies to examine the tumor sizes and          locations. They will answer questions about their health. They may have other tests as          needed.        -  Participants will continue to receive the study drug as long as they have no severe side          effects and the disease is not getting worse.   "
146798|NCT01362790|"     Background:        -  Malignant mesothelioma is a form of cancer that develops on the protective lining that          covers the body s internal organs. It most often occurs on the lining of the lungs and          chest wall or the lining of the abdomen. There is no known cure for malignant          mesothelioma, so researchers are searching for new ways to treat it.        -  Mesothelin is a protein that is found in mesothelioma and other types of cancer cells.          An experimental cancer drug called SS1P is designed to attack cells that have mesothelin          while leaving healthy cells alone. Researchers want to test how effective SS1P is when          it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune          system and may make the SS1P more effective.      Objectives:      - To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat     malignant mesothelioma.      Eligibility:      - Individuals at least 18 years of age who have malignant mesothelioma in the chest or     abdomen.      Design:        -  Participants will be screened with a physical exam, medical history, and blood tests.          They will also have imaging studies.        -  The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will          follow.        -  In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will          have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.        -  On the next three cycles, participants will have pentostatin on day 1.They will have          cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.        -  Participants will have frequent blood tests and other studies. They will receive all          four cycles of treatment as long as there are no severe side effects.        -  Participants will have regular followup visits as directed by the study doctors.   "
146799|NCT01362777|"     The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general     population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated     with various metabolic disorders such as metabolic syndrome, type 2 diabetes. OSAS is a risk     factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS patients suffer     from excessive daytime sleepiness (EDS), a symptom also responsible for at least 30% of     traffic accidents but also other cognitive disorders with significant impact on quality of     life. OSAS generates oxidative stress, inflammation and resistance to insulin and other     systemic metabolic dysregulation of many whose levels are correlated with the severity of the     disease.      Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its     effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept     and/or poorly tolerated, limiting its effectiveness.      Weight loss and regular physical activity are clearly recommended but rarely done in clinical     practice. A few studies have applied to study the effects of rehabilitation training (REE) on     the sleep apnea patients and have shown an improvement in sleep quality, reduction of     awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but their     methodology was questionable, and the number of patients included was too low.      The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program     comprising educational activities, dietary management and individualized exercise training     (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL).     This IET program (24 sessions during 4 weeks) could also help to improve many metabolic     dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk).     Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory control     is increased in OSA (mechanism of leptin resistance). The improved sensitivity to leptin may     play a role in enabling a better control of ventilation in these patients.   "
146800|NCT01362764|"     The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is     absorbed in the body, distributed within the body, and how it is removed from the body) of     the solution formulation to the tablet formulation; therefore the lowest dose available in     the tablet formulation (250 mg) was selected.   "
146801|NCT01362751|"     In this study the investigators aimed        1. to investigate the prevalence of orthostatic hypotension in elderly nursing home          residents.        2. to investigate whether the presence of orthostatic hypotension influences the chance of          successful rehabilitation.   "
146802|NCT01362738|"     The purpose of this prospective randomized study is to assess whether empirical Left Atrial     Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI)     and ablation of extra-pulmonary triggers is superior to the standard approach alone in     enhancing the long-term success rate of catheter ablation in persistent or long-standing     persistent atrial fibrillation (AF) patients.   "
146803|NCT01362725|"     The primary objectives of this feasibility study are to determine the safety of spinal cord     stimulation (SCS) as a therapy in patients with systolic heart failure and to gather     observational information for potential efficacy markers   "
146804|NCT01362712|"     This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an     exploratory Phase I trial designed to collect information as this IP is administered and     evaluated for the first time in humans. The trial will evaluate safety, biodistribution and     dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and     tumor to background imaging data, and correlate image data with caspase 3 activity level on a     surgical specimen analyzed by immunohistochemistry in the cancer subjects. All study results     will be evaluated and analyzed in order to consider the design for future clinical trials.     The information collected under this exploratory, Phase I study will not be used for     diagnostic purposes, to assess the subject's response to therapy, or for clinical management     of the subject.   "
146805|NCT01362699|"     The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge     to drink alcohol in alcohol-dependent study participants who are not seeking treatment.   "
146806|NCT01362686|"     Conduct a comparative effectiveness clinical trial of medication treatment for behavioral     symptoms of Alzheimer's disease in a group of real-world memory care clinics with enhanced     access to the Indiana Network for Patient Care.   "
146807|NCT01362673|"     This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed     to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of     PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed     conditions.   "
146809|NCT01362647|"     Several studies have documented that neuromuscular block often persists in the postanesthesia     care unit (PACU). Residual paralysis is associated with postoperative complications such as     hypoxia, weakness, and respiratory failure. The data in the current literature on residual     paralysis in the PACU were almost exclusively obtained with acetylcholinesterase inhibitors     as they were the only reversal agents available prior to the introduction in clinical     practice of sugammadex (Bridion®) in the European Union and in some other countries, except     for the USA. Reassessment of practice in this regard is relevant, now that sugammadex     (Bridion®) has become available in our country since 2009.      This study is an observational/non-interventional, non-randomized study involving adult     patients undergoing different types of elective surgical procedures requiring general     anesthesia with neuromuscular blocking drugs (NMBDs). Administration of NMBDs and reversal     agents (as well as all drugs which will be used during anesthesia) will be performed in     accordance with routine anesthetic practice.      The study population will comprise about 600 surgical patients. Immediately after the     patients' arrival in the PACU, a study nurse will record the acceleromyographic responses of     their adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the     ulnar nerve. A TOF of 90% will be used as cut-off value to exclude residual paralysis. Pulse     oximetry (SpO2) will be measured continuously throughout the PACU admission, and SpO2 values     will be recorded at 1-min intervals for the first 30 min. PACU nurses caring for the patient     will document the occurrence of any of the following events during the first 30 min of PACU     admission: the number of episodes of hypoxemia (SpO2<90%), the lowest SpO2 observed by     nursing staff, the requirement for either tactile or verbal stimulation to maintain SpO2     greater than 90%, and any clinical evidence of airway obstruction.      The primary objective is to evaluate the incidence of postoperative residual curarisation at     PACU arrival in patients reversed with sugammadex (Bridion®), neostigmine and in case of     spontaneous recovery.      The secondary objectives are to evaluate:        -  Oxygen saturation (SpO2) at PACU arrival        -  Possible episodes of SpO2 <90% in the PACU        -  Airway maneuvers and/or stimulation required to maintain SpO2 >90% in the PACU        -  Need for re-intubation.   "
146810|NCT01362634|"     The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be     randomly assigned (using a random number table) to the interviewer-administered intervention,     the self-administered intervention, and waitlist control conditions upon completion of     screening, informed consent, HIV pretest counseling and test administration, and collection     of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.   "
146811|NCT01362621|"     The study was designed to collect data about inadequately controlled moderate to severe     allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.   "
146812|NCT01362608|"     The purpose of this pivotal Phase III study is to support the registration of canakinumab for     the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by     demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are     contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout     flares relieves the signs and symptoms and prevents recurrence of gout flares compared to     triamcinolone acetonide 40 mg i.m.   "
146813|NCT01362595|"     This study will determine the safety and possibility of giving the amino acid, leucine, in     patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell     transfusions.      The leucine is expected to produce a response in patients with DBA to the point where red     blood cell production is increased. Red cell transfusions can then be less frequent or     possibly discontinued.      The investigators will study the side effects, if any, of giving leucine to DBA patients.     Leucine levels of leucine will be obtained at baseline and during the study.      The drug leucine will be provided in capsule form and taken 3 times a day for a total of 9     months.   "
146814|NCT01362582|"     A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic     adenocarcinoma receiving defined second or higher line chemotherapy and additionally     parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).   "
146815|NCT01362569|"     Chronic kidney disease is widespread in the western world with bacterial infection and sepsis     as common complication. It has been shown that innate immune defence, represented by     dysfunction of neutrophil granulocytes, is impaired in chronic kidney disease. Another impact     of chronic kidney disease on innate immunity is the chronic activation of neutrophils leading     to high levels of inflammatory cytokines, thus contributing to protein oxidation. Oxidation     of human serum albumin (HSA), the major plasma protein, occurs in chronic kidney disease and     leads to further activation of neutrophils. Another important impact of HSA oxidation is the     decrease of its binding capacity leading to impaired detoxification ability of albumin. This     includes reduced clearance of endotoxin, a major component of the gram negative bacterial     cell wall. Circulating endotoxin is recognized by complex formation with lipopolysaccharide     binding protein (LBP) followed by binding to CD14 and toll-like receptor (TLR) 4. High     systemic endotoxin levels occur in chronic kidney disease and may be the result of decreased     clearance ability of HSA and increased gut permeability in combination with intestinal     bacterial overgrowth. High systemic endotoxin is associated with worse outcome in several     diseases and could be used as predictor for mortality in chronic kidney disease patients.      Endotoxemia in renal insufficiency leads to impaired neutrophil function and to increased     albumin oxidation. Oxidized albumin is not able to bind endotoxin adequately any more, which     leads to a further increase in oxidative stress and neutrophil dysfunction, resulting in a     vicious cycle.      195 patients with renal dysfunction will be enrolled and divided into 5 groups. Additionally,     samples of 25 age and sex-matched healthy controls will be collected.      This concept will change the understanding of several aspects of chronic kidney disease and     will potentially help to stratify patients into different groups at risk according to their     endotoxin status, and their immune and albumin dysfunction. The results of this study will     have important implications into the development of novel therapeutic strategies   "
146816|NCT01362556|"     The debate over the administration of sodium bicarbonate in cardiac arrest has been going on     for several decades, swinging like a pendulum from first-line drug to not indicated to     the recent guidelines advocating a small bolus under special conditions (metabolic acidosis,     intoxication, long-term resuscitation). A targeted, blood-gas controlled application under     optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary     studies have shown that an arterial puncture/line as well as measurement of blood gases is     feasible in preclinical conditions. This multicentre trial including 5 centres and 10     physician-staffed emergency systems is designed to compare, in a prospective randomised     controlled study, the effect of a calculated dosage of sodium bicarbonate based on the     patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the     secondary survival of cardiac arrest patients. The null hypothesis is that there is no or     negative impact on survival.   "
146817|NCT01362543|"     The Competence Centre for Transcultural Psychiatry is a clinic specialised in the treatment     of traumatised refugees. There is a lack of studies on treatment effect in traumatised     refugees. There are several studies indicating an effect of cognitive behavioural therapy     (CBT) in Posttraumatic Stress Disorder (PTSD). A few studies point to that CBT could be     effective in traumatised refugees. There are no studies examining if some methods used in CBT     are more useful than others in traumatised refugees. The aim of this study is to examine the     effect of CBT with focus on Stress Management versus cognitive restructuring. Patients     included in this study will be randomised to either Stress Management or cognitive     restructuring. All referred patients will receive medical treatment as usual (described in     the clinic's manual for medical doctors, 2011). All patients that fulfill the inclusion     criteria will be included in the study. Hopefully this study will contribute to improve the     psychotherapeutic treatment offered to traumatised refugees.   "
146818|NCT01362530|"     This study will compare the safety and efficacy of a three-day oral aprepitant regimen     (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced     nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in     pediatric participants. Those who complete this first cycle of treatment and meet certain     eligibility criteria will have the option of continuing for 5 additional cycles of open-label     aprepitant.   "
146819|NCT01362517|"     The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine     (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H.     influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4     months of age according to the local Expanded Programme on Immunisation (EPI) schedule   "
146820|NCT01362504|"     The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level     in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study.     Eighty healthy matched neonates served as a control group.   "
146821|NCT01362491|"     This study will compare the ability of a single-dose of a novel ibuprofen formulation to     relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type     headache   "
146822|NCT01362478|"     Schizophrenia is a disabling mental disease affecting about 1% of the worldwide population.     There is an overall heritability estimate of 68% for the underlying liability to     schizophrenia. Molecular epigenetic studies can overcome the complexities of traditional     genetic studies and provide a new framework for the search of etiological factors in     schizophrenia.      DNA methylation provides an example of an epigenetic process that affects gene expression.     Several postmortem experiments have found that increased DNA methylation at the glutamic acid     decarboxylase (GAD67) and reelin promoter, and hypomethylation of membrane-bound     catechol-O-methyltransferase (MB-COMT) promoter gene in prefrontal cortex of schizophrenia     patients.      Because it is impossible to obtain brain tissue from schizophrenia patients clinically, the     peripheral blood mononuclear cell (PBMC) can partly represent the brain gene expression. It     has been reported to use PBMC as biomarkers for epigenetic abnormalities, such as histone     acetylation and methylation, in schizophrenia. To the investigators best knowledge, gene     promoter DNA methylation abnormalities in schizophrenia have been limited to postmortem     study. It warrants to studying the DNA methylation using schizophrenia's PBMC.      Recently, endophenotype strategy has emerged as an important tool in understanding the     genetic architecture of schizophrenia. Some cognitive functions, such as attention and     working memory (WM), have been used as candidate endophenotypes for genetic studies in     schizophrenia. Synchronized GABA neurotransmission in the dorsolateral prefrontal cortex is     required for adequate attention and working memory, suggesting that impairments in     GABA-mediated inhibition in the prefrontal cortex could contribute to the endophenotype     presentations in schizophrenia.   "
146823|NCT01362465|"     This study is an effort to use left ventricular (LV) lead based measurements to identify late     electrical activation and avoid scar.   "
146824|NCT01362452|"     The goal of this clinical research study is to learn if an infusion of white blood cells     (called T cells) that have been genetically changed is safe to give patients who have     received an umbilical cord blood transplant (UCBT). Researchers want to learn if these     genetically changed T-cells are effective in attacking cancer cells in patients with advanced     B-cell lymphoma or leukemia after they have received an UCBT, how long the changed T-cells     stay in the body, and if adding them to standard transplant could improve how patients     respond to treatment.      Funding Source - FDA OOPD   "
146825|NCT01362439|"     The purpose of this study is to evaluate the effectiveness and safety of paliperidone     extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder     with symptoms of emotional instability, detachment from reality, often with delusions and     hallucinations, and withdrawal into the self) who were receiving treatment with any oral     (having to do with the mouth) antipsychotic medication and who needed to be switched to     paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or     due to side effects.   "
146826|NCT01362426|"     The primary objective of this study is to determine if Australian patients with schizophrenia     treated with paliperidone palmitate under conditions of continuous monitoring of outcomes     over a 12-month period achieve relapse rates comparable to published literature.   "
146827|NCT01362413|"     The aim of the study is to determine whether the evaluation of pro-osteogenic activity of     autologous serum may predict the effectiveness of platelet gel in regenerating bone tissue in     patients with nonunions of long bones.      Serum samples will be collected before the surgery, and their pro-osteogenic activity will be     evaluated by using a bioactivity test (mineralization assay).      In order to determine whether the pro-osteogenic activity of the serum is able to     discriminate between individuals who will achieve or will not achieve bone consolidation, the     laboratory results will be correlated with clinical and radiographic results at 12 months,     when patients will be considered as healed or not healed.   "
146828|NCT01362400|"     The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel     to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell     Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of     the study is to determine the effect of IPI-504, in combination with docetaxel, verses     placebo in, combination with docetaxel, on the growth of cancer   "
146829|NCT01362387|"     Purpose: This randomised trial will compare outcomes and acceptability of an alternative     medical abortion follow-up protocol using standardised text messaging, on-line questionnaire,     or a phone interview and a low sensitivity pregnancy test with the current standard of care     which consists of either a clinic visit and ultrasound scan or a telephone call and high     sensitivity pregnancy test.      Hypothesis: The use of alternative methods to assess outcomes after early medical abortion     will achieve a higher rate of follow-up than women undergoing standard follow-up      Primary aim: To determine the follow-up rate after early medical abortion with an alternative     protocol as compared to a standard follow-up protocol      Secondary aims:        -  To assess complication rates and receipt of further treatment among women in the two          study arms        -  To ascertain women's preferences for mode of communication regarding their post-medical          abortion status        -  To determine provider opinions and preferences for different follow-up modalities   "
146830|NCT01362374|"     This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the     safety, tolerability, and pharmacokinetics of oral GDC-0068 administered in combination with     either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6     chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or metastatic     solid tumors for which standard therapy either does not exist or has proven ineffective or     intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics of GDC-0068     administered in combination with enzalutamide in participants with metastatic     castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this     study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1,     approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be     evaluated to determine the maximum tolerated dose (MTD) of GDC-0068 in a given combination.     Additional participants will be enrolled in Stage 2 (cohort expansion), to further     characterize the safety and tolerability of GDC-0068 in these combinations and to confirm a     potential recommended Phase II dose of GDC-0068 for each regimen.   "
146831|NCT01362361|"     The purpose of this study:      To explore the comparative effectiveness of BIBF 1120 in terms of :        -  Progression-free survival (PFS), objective response, overall survival        -  Evaluate and compare safety   "
146833|NCT01362335|"     In many surgical procedures, anaesthesiological care is provided according to the best     scientific and clinical information available. However, since hemodynamic monitoring until     recently did not allow for beat-to-beat information of the haemodynamical changes, many     fast-changing events may have been unnoticed or have not been investigated as precisely as is     possible today. Moreover, in several surgical procedures - like eye surgery - the     invasiveness of the classical haemodynamical monitoring devices was of such a degree that     until now, in these circumstances these vital parameters were not investigated yet.      Therefore, the availability of this new device, which allows for noninvasive beat-to-beat     assessment of these haemodynamical parameters gives a unique opportunity to investigate our     anaesthesiological management and to elucidate whether improvements are desirable and     possible.      The Nexfin monitor consists of a cuff-micromanometer that is located around the third finger.     It simultaneously uses continuous pressure readings and light-absorption spectrometry to     determine valuable haemodynamical information. Data is recorded and available for subsequent     offline analysis.   "
146834|NCT01362322|"     The purpose of the study is to compare the immunogenicity and safety of a booster dose of     BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in     the previous syringe presentation in healthy adolescents aged 10-15 years.   "
146835|NCT01362309|"     There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form     of dysregulated learning and are influenced by classical conditioning. This is based on     numerous studies indicating that conditioned contextual cues influence craving for alcohol     consumption. As a result, there has been considerable interest in extinction-based treatments     for AUDs (i.e., treatments that focus on extinguishing the associations between alcohol cues     and motivation to drink), referred to as cue exposure treatment To date, extinction-based     treatment for AUDs has resulted in disappointing outcomes in clinical trials and there is     considerable interest in improving this form of treatment. One novel strategy is the use of     pharmacological adjuncts to enhance extinction. Medications that maximize extinction may     minimize subsequent reactions to alcohol cues and, in turn, subsequent clinical outcomes.     This study is examining whether the medication d-cycloserine (DCS) can enhance extinction to     alcohol cues. Recent basic research has revealed that DCS enhances extinction to fear cues     and several lines of evidence suggest that DCS may also enhance extinction to alcohol cues.     Therefore, DCS may serve as a useful pharmacological adjunct to extinction-based treatment     for AUDs. Our primary aim is to examine whether, compared to placebo, DCS (50 mg) will     enhance extinction to alcohol cues under controlled laboratory conditions in     treatment-seeking individuals with alcohol use disorders. We hypothesize that DCS will     generate greater extinction compared to placebo during the subsequent extinction session as     measured by attenuated craving in response to alcohol cues. Furthermore, we hypothesize that     DCS will generate greater extinction compared to placebo at follow-up assessments. This study     is a proof-of-concept test of whether DCS can reduce reactions to alcohol cues under     controlled laboratory conditions. It is a preliminary study using a subclinical number of     extinction sessions and medication administrations to establish whether or not DCS improves     extinction in the laboratory. If proof-of-concept is supported, it will suggest that a     clinical trial is warranted. A clinical sample and clinical context are used to maximize the     potential generalizability from this exploratory study.   "
146836|NCT01362296|"     This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and     safety of GSK1120212 compared with docetaxel in the second line setting for subjects with     locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS     mutation who have failed one platinum-containing chemotherapy regimen. A small subset of     NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the     primary KRAS population, for exploratory purposes.   "
146837|NCT01362283|"     The purpose of this study is investigating the proportion of Cardiovascular disease risk     factors of hypertensive patients.   "
146838|NCT01362270|"     BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical     ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is     helping a patient breathe if he can't breathe on his own. Because of the mechanical     ventilation, these patients also require some medication to help keep them calm. These are     called sedatives or anxiolytics.      The purpose of this study is to see if acupuncture can lower the amount of sedation and     anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a     medical procedure. Hair-thin sterile needles are inserted at specific points on the body.      PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By     using 'fake' acupuncture, no one other than the acupuncturists will know which group a     subject is in. Subjects and the team do not get to pick which subject is in which group.     Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a     day for five days.      Standard of care - Both groups will receive the standard of care while in the study. They     will be mechanically ventilated and given sedatives and analgesics based on the TICU     protocol.      Real acupuncture group - This group will receive real acupuncture with real needles. These     are stainless steel, one time use, needles. This group will also receive ear tacks which     are like little needles that can stay on the ear for a few days. The ear tacks will be     covered with a bandage so no one can tell which group the subject is in.      Sham acupuncture group - This group will receive sham needles. These needles retract into     themselves much like a 'magic sword' rather than poking the skin. Subjects in this group will     not get ear tacks. In order to hide the group the subject is in, a bandage will be used to     cover part of the ear.      HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when     compared to the sham acupuncture group.   "
146852|NCT01362088|"     In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous     Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From     there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate,     the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are     subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number,     the microvascular flow index (MFI).   "
146853|NCT01362075|"     The purpose of this study is to determine the efficacy of local infiltration analgesia as     compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The     investigators hypothesize a reduced pain score and use of supplemental analgesic medication     during the first three postoperative days using local infiltration analgesia.   "
146839|NCT01362257|"     This will be a two-period, open-label study conducted at a single site. Six healthy male     subjects will participate in the study to ensure at least four fully evaluable subjects. Each     subject will receive a single 1000 μg (microgram) oral dose containing 50 μCi (Micro Curie)     of [14C]-GSK573719 and a 65 μg intravenous infusion containing 7.1 μCi of [14C]-GSK573719.     Whilst subjects are in-house, urine and faecal samples will be collected for a minimum of 168     hours (7 days) after dosing or for up to 240 hours (10 days) depending on the amounts of     radioactivity still being excreted after Day 5. Faecal sample collection may continue at home     for up to 14 days. Bile samples will be collected using Entero-Test string sampling of     duodenal bile. Whole blood and plasma samples will be collected at various sample times after     dosing to measure parent drug (plasma only) and total radiolabelled drug related material     (blood and plasma). Urine and faeces aliquots will be taken to measure total radiolabelled     drug-related material. Samples of urine, faeces and plasma will be transferred into a     separate study to characterize and, where possible, quantify metabolites in these matrices.   "
146840|NCT01362244|"     A two-part, randomised, double-blind, placebo controlled, multi-centre study to investigate     the use of mepolizumab (SB-240563) in reducing the need for surgery in subjects with severe     bilateral nasal polyposis.   "
147966|NCT01347489|"     There is no exact scientfic data about gender relationship with cronic pressure wounds (CPW).     This research is aimed first to reveal gender relationship with CPW and aimed secondarily to     reveal the gender related couse(es).   "
146841|NCT01362231|"     The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind,     placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with     Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.      Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in     subjects with IPF and is currently enrolling.   "
146842|NCT01362218|"     This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the     cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril)     as compared to the effect on LDL cholesterol of the reference products (simvastatin,     ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized     in order about 238 subjects to finish the study.   "
146843|NCT01362205|"     This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of     dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol     withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults.      The investigators hypothesize that the integration of dexmedetomidine (Precedex®) with usual     therapy for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal     delirium/delirium tremens (AWD) in critically ill adult patients will reduce the time to     resolution of AWS/AWD, increase the number of delirium-free and ventilator-free days in the     first 28 days of hospitalization, reduce the length of ICU and hospital stays, and improve     neurocognitive and quality of life scores on hospital discharge.   "
146844|NCT01362192|"     The purpose of this study is to evaluate the safety and effectiveness of a new laser for the     removal of unsightly spider veins on the legs. The device used in this study is the Cutera     Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064     nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received     510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological     and vascular conditions, like spider veins.   "
146845|NCT01362179|"     This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized     peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that     the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated     hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized     PBSC donors.   "
146846|NCT01362166|"     The main purpose of this study is to detect the frequency response in the electric wave     transmission through the channels inside human body. With the electric signals in different     frequencies, analyzed by the digital signal processing technique, the adaptability of the     channel for different frequencies may be revealed. With this study there will be a feasible     connection between the physiological signals and the channel theory in Chinese medicine, and     the basis of the physiological signals can be drew out for the description of the internal     organs, the strong or weak, the truth or falsity.      The Zu-San-Li is the open acupoint on foot-Yangming channel, the stomach channel. Qi, the     main concept in TCM, will flow from the open acupoint to go into deep internal organs.     Xian-Gu is another Yu acupoint on foot-Yangming channel. The inborn original Qi flows from     the Yu acupoint infuse into blood vessels. So in this study the investigators will take these     two acupoints for the acupuncture. Since the direction of the channel is from Zu-San-Li to     Xian-Gu, the investigators pick Zu-San-Li as the input and Xian-Gu the output for the     electrical signals.      For this experiment, the investigators planned enrolling 30 male sub-healthy volunteers, aged     in 20-35 years old, to finish the whole experiment procedures.      After the acupuncture, the electric signals of different modes will be input from the     subject's open acupoint (Zu-San-Li), and measure the frequency respond voltage from the     output acupoint (Xian-Gu).      Each subject must complete the acupuncture of Zu-San-Li and Xian-Gu, and be input 5 sets of     the electric signals of different modes two times on the trial. The variety conditions of the     wave form and electric voltage will be recorded and measured respectively.      The investigators plan to obtain the data in six months, and complete the data analysis and     sorting in two months.   "
146847|NCT01362153|"     This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous     administered golimumab in patients with rheumatoid arthritis.   "
146848|NCT01362140|"     The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the     incidence of red blood cell transfusions during the 24-week double-blind treatment period in     anemic patients with low or intermediate-1 risk MDS.   "
146849|NCT01362127|"     The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a     higher degree of complete histological response than neoadjuvant chemotherapy before surgery     in patients undergoing treatment for cancer of the esophagus or cardia.   "
146850|NCT01362114|"     In this randomized, double blinded, Placebo-control Trial, the investigators planned to give     Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.   "
146851|NCT01362101|"     This study is ancillary. Participants will be recruited as part of a separate clinical trial     on effects of two intensive behavioral training programs that evaluates feasibility and     efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to     traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to     compare the effect of MT to that of traditional CBT on a physiological marker of stress,     salivary cortisol concentration, and physiological responses to smoking cues in tobacco     smokers. The investigators will use electrophysiological reactivity to smoking cues in the     form of audio recordings of personalized scripts describing the scenarios associated with the     strongest urges to smoke that will provide a physiological validation to a behavioral     intervention. The investigators will also explore correlations between these biological     markers and self report of stress, craving and negative affect to supplement self report and     behavioral outcome measures with biological and physiological markers to represent     improvement attributed to the intervention.   "
146855|NCT01362049|"     The research objective is to determine which physical therapy (PT) treatment is the most     efficacious for patients with lower back pain (LBP), who have been subgrouped based on     certain clinical features. There is only limited evidence that supports any one PT treatment     for patients with LBP since PT treatment outcomes for exercise protocols are equivocal, given     the heterogeneous clinical features of patients with LBP. Thus, classification of patients     with LBP into subgroups with shared clinical features has been identified as a research     priority by several groups in order to prescribe the most efficacious PT treatment for each     homogeneous subgroup. The investigators hypothesize that particular PT treatments are most     efficacious when applied to patients with LBP, who present with particular clinical and     neuromuscular features.   "
146856|NCT01362036|"     Phase 1, single-center, open-label, sequential cohort dose escalation study. This is a 3 + 3     design study involving at least 3 subjects in ascending dose cohorts, with subjects     participating up to 10 weeks.      The overall study objectives are to evaluate the safety and tolerability of TXA127 in     thrombocytopenic subjects with low or intermediate-1 risk MDS.      Evaluation of the platelet response and the erythroid and granulocytic responses to TXA127     will provide preliminary efficacy data.   "
146857|NCT01362023|"     Our hypothesis is that a regular systematic educational intervention in primary school     improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate     the effects of a 3-year school-based program of lifestyle improvement, including diet and     physical activity, implemented by university students acting as health promoting agents     (HPA) on the prevalence of obesity.   "
146858|NCT01362010|"     The purpose of this study is to evaluate the tolerability and safety and to determine whether     FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.   "
146859|NCT01361997|"     The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior     preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70%     isopropyl alcohol.   "
146860|NCT01361984|"     This is a PI-initiated study taking place only at UCLA, sponsored by Sunovion. The     investigators plan to enroll about 20 subjects who are at least 40 years old and have Chronic     Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the     effectiveness of Brovana and Serevent in helping relieve COPD symptoms. Specifically, the     investigators are looking at how much and for how long the two drugs can open up the small     airways in the lungs. This will be done with breathing tests on all subjects, and with high     resolution CT scans on subjects who agree to this optional part of the study. Half of     subjects will take Brovana (arformoterol tartrate inhalation solution) for 2 weeks and then     Serevent (salmeterol xinafoate inhalation powder) for 2 weeks; the other half will take     Serevent the first two weeks and Brovana the second two weeks. All subjects will also take     Spiriva (tiotropium) and will be provided with albuterol for immediate relief of symptoms.     After a Screening Visit to determine eligibility, subjects will be randomly assigned to     receive Brovana or Serevent for the first 2 weeks, complete Test Visit 1, then receive the     other study drug for 2 weeks, and finally complete Test Visit 2. Visits will include     questionnaires, review of health and medications, and breathing tests before and after taking     the study drug. Subjects who agree to be in the sub-study will also undergo CT scans before     and after taking the study drug at both test visits.   "
146861|NCT01361971|"     Obesity is an epidemic in Western society and is the biggest risk factor for insulin     resistance and type 2 diabetes. The investigators have preliminary evidence showing that     hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires     confirmation in a larger population, and with this study the investigators will also test for     mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress     response proteins following changes in tissue oxygenation may contribute to these     improvements. This study has the potential to yield new and important insights into the     insulin resistance in obesity.   "
146862|NCT01361958|"     The aim of the present study was to evaluate the ability of several doses of NOMAC in     combination with E2 to inhibit ovulation and to assess changes in the gonadotropin and     ovarian hormone profiles, in comparison to a control cycle in healthy-volunteer premenopausal     women.      The study was also designed to check whether the combined administration of E2 and NOMAC at     the dose of 2.5 mg daily induces any changes in the effects of the progestin compared to when     it is given alone.   "
146863|NCT01361945|"     The purpose of this study is to find out what effects, administering infusions of AUY922 with     hormonal therapy (letrozole) and oral targeted drug (lapatinib) will have on the patients     with advanced breast cancer known as ER+ HER2 +.   "
146864|NCT01361932|"     This project will evaluate the effectiveness of 38 videos of discharge instructions for     patients seen in, and discharged from, the emergency department (ED). The investigators will     (1) assess how many ED patients chose view the website, and (2) interview patients who viewed     a video, as well as those who didn't view a video (and therefore received standard care), to     determine whether patients who viewed a video understood their diagnoses and discharge     instructions better.   "
146865|NCT01361919|"     The goal of this study is to compare three methods of teaching medical and nursing students     basic life saving skills. The standard method will teach students how to push on the chest     and to analyze the heart rhythm using a regular monitor. The newer approach will teach the     same skills but use a special heart monitor that provides both visual and verbal reminders.     The third approach will combine both the standard and newer approaches to teaching. Our study     would like to find out the better way to teach these skills and to create a standard way to     grade how well students perform. This study will measure how deep and how fast the students     push on the manikin's chest in a certain amount of time. Other goals include measuring how     well the students use the heart monitor to deliver shocks and analyze the heart rhythm, how     many breaths per minute they give, how long their hands are off the manikin and how well they     think they performed overall.   "
146866|NCT01361906|"     The purpose of this study is to determine whether sensomotoric training can reduce     neck/scapular pain in people with visual disability.   "
147109|NCT01358708|"     Irritable bowel syndrome is a complex condition with a high unmet medical need for effective     and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and     symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a     potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).   "
146867|NCT01361893|"     The overall purpose of this investigation is to better understand factors contributing to the     high incidence of prone sleep positioning in African-American infants. In addition, the     investigators are interested in investigating other races and ethinicities to understand     their beliefs and perceptions and determine differences socioeconomically and socioculturally     within and between groups. The investigators will address the following specific aims:      (-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents     of higher and lower SES.      (-) To identify risk factors for non-use of recommended supine sleep position in families     with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made     by parents of higher SES and lower SES who do nt use recommended supine sleep position, using     qualitative techniques.   "
146886|NCT01360671|"     To determine the efficacy of iv sildenafil in term and near term infants with PPHN     (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric     oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control     group not treated with sildenafil.   "
147967|NCT01347476|"     Patients aged 70 years or older had a higher possibility of high risk cancer than younger     patients.   "
146868|NCT01361880|"     The overall purpose of this randomized trial is to develop and evaluate a systematic approach     to improve African-American parental behaviors specifically with regards to the infant sleep     environment. African-American parents of newborn, healthy term infants will be randomized to     receive either a standard message to avoid bedsharing, eliminate use of soft bedding and soft     sleep surfaces, and to place infants in the supine position for sleep to reduce the risk of     SIDS or an enhanced message to avoid these behaviors to both reduce the risk of SIDS and to     prevent infant suffocation.   "
146869|NCT01361867|"     The aim of the study is to assess the ability of healthy subjects to generate a motor     adaptation in response to a mechanical perturbation generated by a robotic system for     treadmill-based gait training (Lokomat by Hocoma AG, a device that received 510K FDA     clearance).   "
146870|NCT01361854|"     Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected     of sleep-disordered breathing.      First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with     the portable monitoring.      Second one: hook-up is performed home, around 7 PM, and the patient has not to move after     hook-up.   "
146871|NCT01361841|"     Intraocular pressure (IOP) is considered to be the main risk factor for progression of     glaucoma and therefore the main target of therapy. Pharmacologic treatment of glaucoma has     changed considerably during the last decades due to the introduction of prostaglandin     analogues. Three of these are commonly used in North America: latanoprost (Latanoprost T,     Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan).      There have been several studies to evaluate their effectiveness. The three seem to be     equivalent, according to the only study that has compared the molecules. Latanoprost is     employed initially, due to its paucity of side effects when compared to the other two     analogues. However, if it is not effective, several studies ahve shown that a result is     possible using either travoprost or bimatoprost. No study has been conducted to date     systematically comparing the three molecules in cases of resistance to latanoprost. In     actuality, the investigators patients will receive treatment identical to current practice     with the exception of the group continuing with latanoprost. Several studies confirm the     benefit of changing prostaglandin analogues if the first has not signficantly decreased the     IOP (Palmberg et al. 2004). Each prostaglandin has unique properties which may cause the     mechanism of action to vary slightly among patients. (cf. Pharmacological Aspects)      The goal of the study is thus to evaluate the efficaciousness of latanoprost, bimatoprost and     travoprost in their IOP-lowering capacity in patients who do not initially respond to     latanoprost.   "
146872|NCT01361828|"     The purpose of this study is to investigate the possible affection of optic nerve and retinal     functions following intravitreal bevacizumab injection in human eyes.   "
146873|NCT01361815|"     The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep     Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake     Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued     the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol#     CTP-0001-00).   "
146874|NCT01361802|"     The development of a new Ambroxol spray formulation for the treatment of sore throat pain     associated with acute pharyngitis requires an initial phase II study to be conducted in order     to select the most appropriate dose for pain relief.   "
146875|NCT01361789|"     Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID     or COX-2 selective inhibitor gives better pain relief than either of the drugs used     separately. The investigators group has also shown that adding dexamethasone on top of a     regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest     after ambulatory breast cancer surgery.      The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The     investigators want to evaluate whether a selective COX-2 selective inhibitor or a     glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can     provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL     surgery.   "
146876|NCT01361776|"     Antibody titers after tick-borne encephalitis (TBE) vaccination are less in elderly and     vaccination breakthroughs are more common in this age group. This has prompted Swedish     authorities to recommend an additional dose in the initial vaccination schedule (= 0+30+90     days instead of the usually recommended 0+30 days. The investigators intend to evaluate this     regime.   "
146877|NCT01361763|"     This study is a Phase II, randomized, crossover trial designed to compare one fixed dose of     dabigatran with open-label use of ASA in patients affected by CADASIL; the study is a safety     trial, and the primary objective is to assess that dabigatran is not less safe than ASA in     subjects with CADASIL.   "
146878|NCT01361750|"     This study is to investigate the effects of narrowed gastric tube on postoperative     nutritional status and the quality of life in esophageal cancer patients treated with     Ivor-Lewis esopagectomy in a 12-month follow-up period.   "
146903|NCT01361659|"     There is an increasing number of patients with a coronary anatomy that does not allow     additional revascularization procedures, while the patients suffer from angina pectoris at     rest or at minimal exercise levels despite optimised medical therapy. There is a lack of     therapeutic options for this group of so called no-option patients. Goal of the project is     to implement the shockwave therapy for no-option coronary artery disease patients and to     evaluate its potential benefit on regional myocardial perfusion, on regional myocardial     function and on the potential improvement in symptoms and quality of life.   "
146885|NCT01360684|"     Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7     couples. Measuring basal body temperature is a technique that has been used since the 1930's     to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT     charts to predict ovulation, as it has not been established to reliably confirm ovulation.      The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure of     axilla temperature whilst worn under the arm.      The investigators plan to compare the temperature measurements of the DuoFertility sensor     with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's     menstrual cycles, up to 10 cycles per women.      The investigators aim to investigate if continuous axillary skin temperature measurement     obtained from the DuoFertility sensor, provides comparable results for identifying the     occurrence of ovulation as the gold standard transvaginal ultrasound scan.   "
146879|NCT01360762|"     Visceral leishmaniosis (VL) is widely reported in Ethiopia, with about 30% of cases being     associated with human immunodeficiency virus (HIV). In absence of antiretroviral treatment     (ART), poor prognosis, high mortality and high relapse rates are characteristic of Ethiopian     VL patients with HIV co-infection. Conversely, co-infection can be successfully managed via a     combination of effective treatment of the initial episode, timely ART and prevention of     relapses.      Actually, until cellular immunity returns with ART, the patient is at risk of VL relapses,     which can result in death, severe illness, reduced ART efficacy, drug-resistance and possibly     transmission of drug-resistant Leishmania donovani. Patients most vulnerable to relapses are     those with high levels of immunosuppression, with previous VL episodes, or with opportunistic     infections (OIs). The most important factor to prevent relapses seems to be the clearance of     visible parasites.      Limited studies in Europe show that HIV co-infected patients may benefit from secondary     prevention with antimonials (part of mainstay treatment for VL in Ethiopia) and pentamidine     (PM), not used for VL treatment in Africa. Such maintenance treatment has not been studied in     African VL, but the poor outcomes without secondary prevention highlight a need of better     care to patients at risk of relapse.      This prospective cohort study aims at documenting the patient's outcomes of secondary     prophylaxis with PM in VL-HIV co-infection, in terms of time to relapse or death, safety and     feasibility, before it can be considered for general use in Ethiopia. A placebo group is not     included, due to the clear advantages of the intervention to the patient population.   "
146880|NCT01360749|"     Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina     (lidocaine cream) in reducing pain associated with laser hair removal in women.   "
146881|NCT01360736|"     The investigators propose to test the efficacy of a brief, readily accessible, and     personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown,     2012).   "
146882|NCT01360723|"     The investigators previously pointed out the significant association between urinary arsenic     profiles and urothelial carcinoma (UC) risk through a 12-year follow-up study. Further, the     investigators observed the increased UC risk in people with lower plasma folate and higher     homocysteine than those with higher plasma folate and lower homocysteine in 2010.     S-adenosylmethionine (SAM) is one factor included in one-carbon metabolism pathway and is the     main donor of methyl group in cells. The ratio of SAM and its metabolite     S-adenosylhomocysteine (SAH) not only reflected the intake level of dietary folate but also     demonstrated the extent of global DNA methylation. These factors might play important roles     in UC carcinogenesis. The investigators would expect to take three years to explore the     interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary     arsenic profiles, the polymorphisms and haplotype of Glycine N-methyltransferase (GNMT) and     UC. In the first year, the investigators would measure the levels of plasma folate,     homocysteine, SAM and SAH and evaluate the associations between these factors and UC risk. In     the second year, the investigators would set up the method of immunohistochemistry stain and     compare the differences between the global DNA methylation from bladder tissues and blood. In     the last year, this investigators would analyze the GNMT gene polymorphism and haplotype     variation. At the same time, the investigators would explore the impact of GNMT genetic     variation and global DNA methylation on UC risk. Based on the results from our research, the     investigators might propose that the decreased ratio of SAM/SAH resulted in UC risk     increased. This mechanism might be through the changed levels of urinary arsenic profiles and     global DNA methylation.   "
146883|NCT01360710|"     Obesity is a major risk factor for the development of hypertension. Based on population     studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension     can be directly attributed to obesity. Obesity per se is commonly associated with activation     of the sympathetic nervous system with a predominant increase in sympathetic outflow to the     kidneys and the peripheral vasculature and there is now conclusive evidence that heightened     sympathetic nerve activity is a major contributor to the elevation in blood pressure     associated with obesity, particularly in young subjects. In line with these findings, dietary     weight loss has repeatedly been demonstrated to result in reduced sympathetic nerve activity     and lower blood pressure levels.      Several lines of evidence have well documented the significant role of SNS activation in     obesity associated hypertension and target organ damage. Weight loss is the preferred     treatment option for obesity and its consequences and reduces both SNS activation and blood     pressure. In the real world however, weight loss maintenance is rarely achieved in obese     patients highlighting the urgent need for alternative treatment strategies. Given the crucial     involvement of SNS activation in various aspects of the obesity related increase in blood     pressure, target organ damage and cardiovascular risk, the use of sympatho-inhibitory agents     at an early stage is an obvious choice.      The investigators therefore plan to examine the effects of the centrally sympatholytic agent     moxonidine on blood pressure and the morning surge in blood pressure, sympathetic activity,     regression of early target organ damage (heart, kidney and endothelium), metabolic and     inflammatory markers in young obese subjects with hypertension in a randomized, double-blind     clinical trial with the angiotensin receptor blocker irbesartan as an active comparator to     achieve similar blood pressure reductions in both groups. The investigators hypothesize that     moxonidine treatment will result in significant improvements in these outcome parameters and     beneficial effects beyond simple blood pressure reduction.      Findings from this study could pave the way for an early and pathophysiology- tailored     treatment strategy of obesity related hypertension and its detrimental consequences.   "
146884|NCT01360697|"     In this demonstration project (JADE in Jiangsu & Anhui Program, JADE-JA in short) led by key     opinion leaders in the field of diabetes and endocrinology in Jiangsu and Anhui area and     supported by the ADF, shall recruit 4800 type 2 diabetic patients attending medical     out-patient clinics in the area to compare the effects of usual versus structured care     (non-JADE vs JADE) on metabolic control, quality of life and behavioral changes. After     explanation by trained doctors and nurses and with written informed consent, patients will be     randomized to either the JADE or non-JADE group. The former encompasses all components of the     structured care delivered by a trio-team of doctor, nurse and Healthcare Assistant (HCA)     while the non-JADE group only consists of comprehensive assessments (CA) at baseline and     12-month with patients managed in the usual manner thereafter. At the end of 12 months, all     patients will undergo repeat comprehensive assessments for comparison of rates of attainment     of treatment targets, behavioral changes, quality of life and default rates. The     acceptability of the JADE-JA Program by patients and the trio-team will also be evaluated.      The investigators hypothesize that the use of state of the art information technology to     record, manage and analyze the large amount of clinical information generated during various     consultation visits will improve the effectiveness and efficiency in implementing these care     protocols through decision support and regular feedback to both patients and care team.   "
147110|NCT01358695|"     The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of     ANT-1207 in the treatment of Crow's Feet.   "
146887|NCT01360658|"     Solar urticaria is a rare but debilitating disease that can severely impact the quality of     life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic     drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or     immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic     urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7     patients, to dramatically improve 71% of patients. In an open-label prospective multicenter     study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10     patients affected with severe and refractory solar urticaria.   "
146888|NCT01360645|"     To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive     substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in     patients with Major Depressive Disorder who demonstrate an incomplete response to a     prospective trial of the same assigned FDA approved ADT   "
146889|NCT01360632|"     To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive     substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in     patients with Major Depressive Disorder who demonstrate an incomplete response to a     prospective trial of the same assigned FDA approved ADT   "
146890|NCT01360619|"     The researchers believe that the multifunction Keito devices shares with TANITA TBF-300     (K014009) the same efficacy on the body fat measurement. Even if the body contact points are     not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate     gives results as similar as the multifunction keito does.   "
146891|NCT01360606|"     This is a phase I dose escalation study. Dose escalation will be via the traditional up and     down scheme. SBRT:      Patients will receive one of the following radiation regimens:        -  50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.        -  60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.        -  75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period.   "
146892|NCT01360593|"     The current study seeks to further investigate the impact of up-front systemic therapy in     combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic     adenocarcinoma.   "
146893|NCT01360580|"     Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged     invasive ventilation (more than seven days), using a clinical statement. All consecutive     patients are screened, and clinical evaluation is performed during 48h after patient's     extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be     created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data     complementary are notified at day 28 (pneumonia? nutritional status?)   "
146894|NCT01360567|"     The aim of the study is to examine whether the extract of green tea is effective on type 2     diabetes and hyperlipidemia.   "
146895|NCT01360554|"     This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the     efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients     with advanced non-small cell lung cancer, previously treated with at least one prior regimen.     Analyses of primary objective (Progression Free Survival) will be done in two co-primary     populations as defined in the protocol.   "
146896|NCT01360541|"     Radiofrequency ablation versus endoscopic surveillance in the management of low grade     dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.   "
146897|NCT01361737|"     Could possible markers in serum obtained in the first trimester predict the human-pregnancy     specific disorder pre-eclampsia?   "
146898|NCT01361724|"     Problems with balance and walking that affect mobility are an inevitable cause of decreased     quality of life in older people with chronic neurologic conditions such as Parkinson's     disease (PD). Although there is evidence that exercise can improve mobility in the elderly,     the investigators don't know: 1) What is the best mode of exercise intervention delivery     (i.e. individual therapy in a clinic, home exercise program, or a group class)? and 2) how do     other problems common in people with PD and/or the elderly affect outcomes? Although most     physical therapy is carried out individually, a group or home program would be most     cost-effective so the investigators need to know if they are just as effective. Since most     older people with chronic neurologic diseases also have other problems affecting mental     function, muscles and joints and/or pain, it is important to understand how these other     problem affect the success of their therapy. The purpose of this study is to investigate how     PT intervention should be delivered to patients with chronic neurologic disease who also have     other problems. The investigators will using elderly people with PD who have one or more     co-morbidities associated with PD and/or aging. Sixty people PD and co-morbidities will be     randomized into 1of 3 groups; home program, individual PT or group exercise class. Each of     the 3 groups will be led by the same PT providing a novel sensory-motor agility program     developed by our laboratory. All groups will perform the same type of exercises 3 X/week for     4 weeks. Improvement in the Physical Performance Test of disability will be used to determine     the success of therapy. To determine how and why mobility was improved by therapy, changes in     gait, balance, and quality of life will be measured. Gait and balance will be measured with     new, wearable motion sensors (iPOD size) while standing up from a chair, walking, turning     around and sitting back down. The findings from this study will help guide rehabilitation     treatment for complex , chronic problems affecting mobility in older people.   "
146899|NCT01361711|"     This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab     together works in treating patients with previously untreated chronic lymphocytic leukemia     (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in     different ways. Some block the ability of cancer to grow and spread. Others find cancer cells     and help kill them or carry cancer killing substances to them. Giving alemtuzumab together     with ofatumumab may kill more cancer cells   "
146904|NCT01361646|"     This will be a dose block-randomized, double-blind, active and placebo controlled, single and     multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic /     pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and     laboratory tests will be conducted for safety/tolerability evaluation and serial blood     samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be     conducted at specified time points.   "
146905|NCT01361633|"     The goal of this study is to determine whether a study medication (d-cycloserine) improves     the ability of older adults to perform on tests of neuropsychological functioning. Tests of     neuropsychological functioning assess attention, memory, and executive functioning skills     (for example, problem-solving, planning and organizing skills). It was hypothesized that     participants who received study medication would perform better on neuropsychological tests     than would participants who received the sugar pill.   "
146906|NCT01361620|"     The study seeks to identify genomic markers associated with aspirin resistance.   "
147968|NCT01347463|"     Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle     advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.      The investigators attempt to validate this long-standing statement.   "
146907|NCT01361607|"     This 9-week study aimed to determine the efficacy, safety and tolerability of Sativex®     (Nabiximols) as an adjunctive treatment, compared with placebo in relieving uncontrolled     persistent chronic pain in patients with advanced cancer.      Eligible patients were not required to stop any of their current treatments or medications.   "
146908|NCT01361594|"     High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are     associated with increased risk of hospital complications. Blood sugar control with     intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac     bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before     or after surgery). It is not clear what the best insulin regimen is or what is the best blood     sugar target in these patients. Accordingly, this research study aims to determine optimal     blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will     be divided in two groups. The intensive insulin group will be maintained at blood glucose     between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180     mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are     approved for use in the treatment of patients with diabetes by the FDA (Food and Drug     Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery     will be recruited in this study. Patients will be recruited at Emory University Hospital,     Emory Midtown Hospital and Grady Memorial Hospital.   "
146909|NCT01361581|"     Citrate anticoagulation is associated with metabolic side effects which are linked to a     portion of citrate reaching systemic circulation. Data on significance of systemic gain of     citrate and its relationship to method configuration are missing. Patient might also receive     certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution     is used. The authors test variable methods of indirect estimate of systemic dose of citrate     which would allow to quantify the metabolic input without mostly unavailable measurements of     citrate levels.   "
146910|NCT01361568|"     The primary purpose of this study is to determine if CR845 is effective in treating the pain     associated with a laparoscopic hysterectomy.   "
146911|NCT01361555|"     The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836     in patients with depression.   "
146912|NCT01361542|"     Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of     unknown etiology primarily affecting the spine and sacroiliac joints. In addition to     formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a     prominent feature in AS-thus showing the paradox of new bone formation at abnormal sites     coexisting with reduced bone mass & increased fracture risk. Osteoporosis is a common     complication of AS, with an incidence between 18.7% and 62%. TNF alpha has a central role in     disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and     decreased strength- i.e. osteoporosis. The investigators hypothesis that anti TNF therapy is     effective in active AS resistant to conventional therapy and helps in improving the bone     density and over all bone health.   "
146913|NCT01361529|"     The purpose of this study is to determine the tolerance and maximum tolerated dose (MTD) for     FLP Injection with multiple dose in tumor patients.   "
146914|NCT01361516|"     The aim of the study is to compare the impact intravenous sedation versus general anesthesia     on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.   "
146915|NCT01361503|"     The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and     imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20     children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For comparison,     MRS and MRI will also be obtained from 10 healthy control subjects, matched to the 20     subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be administered     a detailed assessment battery consisting of cognitive assessments (neuropsychological battery     including subsets of the DANVA2 and the CANTAB) and measures of psychosocial functioning     (SAICA and M-FES). The study includes 1-3 visits for the screening period at Massachusetts     General Hospital (approximately 4 hours of assessments) and one scanning visit at McLean     Hospital (approximately 1.5 hours).      The investigators hypothesize that youth with ASD versus controls will exhibit increased     glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho     concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize     that compared to neurotypical controls, the structural integrity of white mater tracts will     be disrupted in ASD.   "
146916|NCT01361490|"     Obesity may have implications on the individual's participation in working life through     different mechanisms such as comorbidity and loss of functional level. The investigators also     know that when exiting the working force, it is difficult to get back later. As     rehabilitation back to working life is often not a very focused aim with weight loss     treatment, this study sets this as a primary aim by involvement in a 4 week stay at a     rehabilitation clinic followed by 48 weeks work practice programme at one of three different     companies.   "
147211|NCT01357369|"     This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron)     given routinely to pregnant women who are planning to deliver via cesarean section. The     investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental     transfer over time, and the subsequent metabolism of the transferred drug in the neonate.   "
146917|NCT01361477|"     As general surgical intensive care units of the biggest tertiary referral university of     Thailand with more than 1,000 admissions/year. Recently, more complicated perioperative care     surgical patients were accepted with high complications and resource utilization. Good data     registration was needed to provide information for quality improvement and resource     allocation. This prospective observational (crosssectional) study was designed to register     patient > 18 years who will be admitted to these ICUs for 1 years to explore the adequacy of     these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU     complications and adverse outcome /ICU readmission within 72 hours after discharging from     ICU.   "
146918|NCT01361464|"     This phase II trial is studying how well tipifarnib works in treating older patients with     acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of     the enzymes needed for cell growth.   "
149179|NCT01331473|"     To compare the incidence of new ischemic brain injury detected with magnetic resonance     imaging (MRI) after carotid artery stenting in patients treated with and without proximal     cerebral protection (Gore Flow Reversal System).   "
146919|NCT01361451|"     There are 24,000 admissions each year to Intensive Care Units (ICU) in the United Kingdom due     to pneumonia, asthma and a common condition called chronic obstructive pulmonary disease     (COPD), with rates of death of 10%, 40% and 50%, respectively. These conditions account for     10% of all ICU admissions. It is therefore important to find out if it would be possible to     detect deteriorations in patients with breathing problems early, in order to increase     appropriately their level of care.      Clinical early warning scores (EWS) are used in many hospitals to detect patients whose     medical condition is getting worse, and who are likely to need admission to intensive care or     high dependency care units. EWS are usually calculated from several measurements taken from     the patient, such as blood pressure, temperature and heart rate. However, they are often     inaccurate as they need to be calculated manually by nursing staff from a number of     measurements taken from a variety of different devices. Furthermore, even when accurately     calculated, it is not clear how helpful EWS are in predicting whether or not patients will     deteriorate.      Neural respiratory drive (NRD) is an objective indicator of breathlessness, and can be     derived from the amount of electrical activity occurring in certain muscles used in     breathing. The Myotrace system measures this electrical activity, as well as measurements     such as rate of breathing and heart rate. It then analyses these measurements together to     help identify patients at risk of deterioration.      This study will use Myotrace to monitor patients with severe breathing difficulties due to an     acute worsening of chronic obstructive pulmonary disease, for early identification of failure     to respond to medical treatment.      Patients will be recruited at St. Thomas' Hospital.      This research is funded by the Guy's and St. Thomas' Charity.   "
146921|NCT01361425|"     Introduction: Hypertensive emergency in pregnant women with pre-eclampsia should be treated     for preventing stroke and placental abruption. However, the benefit of antihypertensive     medication maintenance remains unclear, mainly due to the potential risk of fetal growth     restriction.   "
146922|NCT01361412|"     The aim of the study is to identify changes in potential biomarkers after peptide     immunotherapy for that may subsequently be developed as biomarkers that correlate with     clinical efficacy.   "
146923|NCT01361399|"     The purpose of this study is to investigate the analgesic efficacy of a single dose of a     fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult     patients with sore throat associated with a common cold in comparison to a single treatment     with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active     ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to     provide relief from sore throat pain by sequential action. A very fast inset of action will     be achieved by the locally acting Lidocaine and a long duration of action will be achieved by     the systemically acting Aspirin.   "
146924|NCT01361386|"     The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years     following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e.     STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality     of life of these AMPs in a 'real-life' setting.   "
146925|NCT01361373|"     Background:      Cerebral palsy (CP) is the main cause of childhood immobility and is defined as a non     progressive injury to the developing central nervous system in children younger than 3 years,     resulting in neurological and musculoskeletal abnormalities. The main pathophysiological     causes are encephalopathy of prematurity (periventricular leukomalacia) hypoxic ischemic     encephalopathy. Infections, infracts and migration defects are other less common causes of     CP. The brain injury leads to functional motor impairment impacting on daily activities     commonly manifests as a movement disorder: pyramidal, leading to spasticity and     extra-pyramidal leading to dystonia and chorea. In most cases extensive brain injury causes a     mixed movement disorder. Dystonia is defined as involuntary muscle contractions causing     twisting and abnormal postures. While the neurological underpinnings of CP remain unknown, a     link between low dopamine and increased acetylcholine release has recently been reported in     dystonia. Dopamine is considered the first line of treatment in children with dystonia and CP     followed by anticholiergic treatment with trihexphenidyl. The recommendation of dopaminergic     treatment is based on need to rule out dopamine-responsive-dystonia, a rare genetic disorder,     and on single case study reporting improvement in CP. A double blind study support or refute     the use of dopamine treatment for dystonic CP was never reported. Working hypothesis and      Aims:      In children with CP due to a clear underlying pathology, dopamine treatment will not improve     daily function. Methods: the investigators will perform a double blinded randomized     controlled crossover study. 50 children ages 4-18 years with a clear pathophysiological cause     for CP will be enrolled. Each child will receive dopamine and placebo treatment for 2 weeks     with a 2 week washout interval. Participants will be randomized into 2 groups; one will     receive placebo followed by dopamine and the other vice versa. The primary outcome measure,     goal-attainment-scale, and secondary outcome functional measures (such as box and blocks, 9     hole pegs, pronation/ supination, finger sequencing) will be assessed at the beginning and     end of each treatment as well as parent questionnaires regarding satisfaction and side     effects.      Expected results:      No functional improvement with dopamine treatment compared to placebo.      Importance:      supplying sufficient data to support or refute the use of dopamine treatment for dystonic CP.      Probable implications to Medicine:      this may lead to a change in medical treatment guidelines for children with CP.   "
146926|NCT01361360|"     In the US, every year approximately 30,000 infants are born very prematurely, with birth     weight less than 1000 grams. These infants usually require ventilators to help them breath     normally during the first few weeks of life. Although the ventilator is lifesaving, it can     also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called     permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury.     Importantly, there is new research showing that high carbon dioxide may cause brain injury.     In our proposed research, we will use magnetic resonance imaging methods to evaluate the     brain in 40 very premature infants at term−equivalent age (Half of them had permissive     hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse     effect on brain development.   "
146927|NCT01361347|"     The purpose of this study is to study the number of Participants with Adverse Events as a     Measure of Safety and Tolerability.   "
147212|NCT01357356|"     The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray     formulations in patients with nocturia for a total duration of 14 weeks.   "
146928|NCT01361334|"     Long term disease-free survival (DFS) of patients with acute myeloid leukemia (AML) is still     poor. Recently, so-called targeted therapy for cancer has been introduced to the treatment     of patients with AML. This phase II clinical trial will explore the efficacy, safety, and     pharmacodynamics of the tyrosine kinase inhibitor pazopanib in patients with relapsed or     refractory AML or patients with AML who are not eligible for intensive treatment. Biomarker     studies will be included to study whether the targets are indeed inhibited and whether this     leads to decreased BM angiogenesis. Toxicity assessments will be included, and the     antileukemic effectiveness will be studied.   "
147096|NCT01358877|"     This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and     efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in     participants with operable HER2-positive primary breast cancer. After surgery, participants     will be randomized to receive either pertuzumab or placebo intravenously (IV) every 3 weeks     (q3w) for one year, along with 6-8 cycles of chemotherapy and 1 year of trastuzumab IV every     3 weeks. This study will be carried out in collaboration with the Breast International Group     (BIG).   "
146929|NCT01361321|"     Edentulism refers to a state of full or partial lack of teeth. This situation may interfere     with essential functions such as mastication, speech and even appearance.      Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to     restore edentulus alveolar ridges by providing support and anchorage for removable or fixed     dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of     sufficient bone tissue volume to support the dental implant.A situation like this may     originate from a variety of reasons such as residual bone atrophy, prior alveolar bone     destruction due to periodontal disease and even a traumatic tooth extraction. In such cases,     a routine alveolar bone augmentation is done to enable a dental implant installation at this     site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone     ridges. It relies on an inert membrane covering a bone substitute placed over the bony site     requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by     the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to     the bony defect area.      The investigators research is a aimed to preform a follow up after patients who already went     through a GBR procedure and before inserting a dental implant. Patients answering the     inclusion but not the exclusion criteria will go through an alveolar computerized tomography     (C.T) done routinely before inserting dental implants.At the day of Dental implantation -     residual bone left from the site of implantation (after preparing the site with a trephine     bur) will be taken to a histological analysis. The results from the C.T and the histological     examination will be analyzed for bone quantity (volume) and quality and will allow a     comparison of bone characteristics obtained by using different routinely used bone     substitutes.   "
146930|NCT01361308|"     The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine     mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with     menopause.   "
146931|NCT01361295|"     Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state,     which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The     induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a     non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter     has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be     expected that these procedures induce a lower level of procoagulation.      Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients     undergoing cooled-tip catheter ablation of AF. In this study there will be used to different     catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter     is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis     and CE may be increased.      The goal of this study is to determine the effect of two different ablation catheters on the     induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF     undergoing PVI.      Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show     a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF     undergoing PVI with the cooled-tip catheter.   "
146932|NCT01361282|"     Many patients with endothelial dysfunction also present with cataracts. It is therefore     common practice to perform cataract extraction and intraocular lens (IOL) implantation during     the same operation and immediately prior to Descemet's Stripping Automated Endothelial     Keratoplasty (DSAEK), in order to minimize trips to the operating room and the associated     risks of ocular surgery. However, the unique posterior corneal anatomy of the DSAEK recipient     makes it difficult to predict pre-operatively the proper power of IOL to place, and some     patients end up with a mismatched lens that requires spectacle correction. The current gold     standard for IOL power calculation (A-Scan optical biometry) takes measurements of the     anterior surface of the cornea and makes assumptions about the posterior surface that are     violated by the unique hourglass shape of the donor DSAEK graft. New optical coherence     tomography (OCT) technology provides us with the ability to measure curvature in both the     anterior and posterior aspects of the cornea in order to generate an IOL calculation that has     the potential to give more accurate results for our DSAEK patients.      The investigators will be using the Optovue to perform corneal power analysis on patients who     have already received DSAEK and cataract surgery, in order to compare the post-op Optovue     power calculations to the pre-operative power calculations provided by the A-Scan. If the OCT     is shown to provide accurate IOL power calculations, then some patients might be better     served by a two-stage procedure where DSAEK is performed and then followed six months later     by cataract surgery using the OCT to calculate IOL power.   "
146933|NCT01361269|"     Few efficient drugs for malaria treatment are available so far. Due to increased exposure of     these drugs and due to the high risk of development of drug resistant strains of Plasmodium     falciparum, new drug combinations have to be actively investigated. The investigators will     test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment     in acute uncomplicated malaria in children aged 3-10 years.   "
146934|NCT01361256|"     This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in     patients with bilateral moderate to profound central vision impairment due to end-stage     age-related macular degeneration.   "
146935|NCT01361243|"     The purpose of this study is to evaluate the efficacy of a parent intervention (NOURISH+)     aimed at reducing the problem of overweight and obesity in children.   "
146936|NCT01361230|"     The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial     comparing sedation management using a protocol based on responsiveness with standard sedation     management. The hypothesis is that responsiveness will improve a range of patient-based and     economic outcomes, including the duration of mechanical ventilation and duration of coma in     the ICU. The purpose of the pilot study is to gather information for designing a full study     that might show the validity of the outcome hypothesis.   "
147065|NCT01359280|"     Persistent adherence to antiretroviral therapy is necessary for the successful treatment of     HIV infection. The proposed research will test a theory-based behavioral intervention that     includes objectively monitoring HIV treatment adherence with corrective feedback delivered by     cell phone. The study will also test the independent effects of an automated text message     reminder system for sustaining adherence improvements. The intervention under study has     utility for people living with HIV/AIDS In resource limited rural and urban settings.   "
147097|NCT01358864|"     The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or     24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in     chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.   "
147098|NCT01358851|"     The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to     cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch     biopsies).   "
146937|NCT01361217|"     Inhibitory drug-drug interactions (DDIs) are a considerable concern as inhibition of drug's     clearance can lead to increased plasma concentrations and subsequent adverse events and     toxicities. Fluoxetine (Prozac®) is a widely prescribed antidepressant, but is also a potent     inhibitor of cytochrome P450 (CYP) enzymes. Fluoxetine was chosen as the model inhibitor for     this study because it is a clinically important inhibitor of multiple CYP enzymes with     varying potencies for each isoform. From in vitro data, fluoxetine is predicted to be a     moderate inhibitor of CYP2D6, but a strong inhibitor of CYP2C19 and CYP3A4. However, in vivo     fluoxetine causes a potent interaction with CYP2D6 and a weak-to-no interaction with CYP3A4.     The magnitude of the in vivo interaction of fluoxetine with CYP2C19 is not known. This in     vitro-to-in vivo discrepancy is of concern for two reasons: 1) In clinical drug development,     in vivo drug-drug interactions are tested only when in vitro experiments predict a risk for     in vivo DDIs and 2) Because in vivo DDI's are tested using a rank order approach of going     from the most potent in vitro interaction to the least potent until no interaction in vivo is     observed. In this study the interaction between fluoxetine and CYP3A4, CYP2C19 and CYP2D6     will be quantified simultaneously and the quantitative in vitro-to-in vivo predictions     tested. Fluoxetine will be orally administered daily for 14 days and CYP1A2, CYP3A4, CYP2C19     and CYP2D6 activity will be tested in the end of fluoxetine dosing using a cocktail of CYP     probes including caffeine, midazolam, omeprazole and dextromethorphan. Lovastatin will be     administered on a separate day and used as a second CYP3A4 probe to test whether CYP3A4     inhibition by fluoxetine depends on the contribution of intestinal CYP3A4 to the probe     clearance. Plasma and urine samples will be collected for 12 and 24 hrs, respectively, during     the control sessions (before fluoxetine administration) and for 24 hrs during the treatment     sessions (fluoxetine multiple dose). The concentrations of each of the probe drugs and their     metabolites (when applicable) as well as fluoxetine and its metabolites will be measured in     the collected samples and pharmacokinetic analysis will be performed. The primary outcome     measures for CYP inhibition will be the increase in the area under plasma concentrations time     curve (AUC) of each of the probes.The null hypothesis of this study is that the area under     plasma concentrations time curves (AUCs) of caffeine, dextromethorphan, omeprazole, midazolam     or lovastatin are the same between the control session and the fluoxetine session. Because     lovastatin has the greatest variability in its baseline pharmacokinetics the study was     powered based on the specific null hypothesis for lovastatin. The alternative hypothesis is     that fluoxetine decreases the clearance of the probe drugs resulting in a significant     increase in the AUCs between the control and study sessions.   "
146938|NCT01361204|"     Long-term practices in a hospital setting and community pharmacy might induce chronic stress     in students. Alterations of salivary amylase activity will be measured in students during     pharmacy practices as a marker of stress. Theanine is reported to have anti-stress effect on     experimental animals under chronic stress and on humans under short-term stress. The purpose     of this study is to measure stress symptoms in students during long-term pharmacy practices     and to evaluate the efficacy of theanine in suppressing chronic stress, by measuring the     salivary amylase activity.   "
146939|NCT01361191|"     The aim of the study is to evaluate the event free survival at three years in patients with     diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction     therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage     treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET     after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP     without transplant.   "
146940|NCT01361178|"     Immunosuppressive therapies have led to remarkable improvements in survival in lung     transplantation (LT) patients. However, one important adverse effect of these therapies has     been the increasing emergence of hypogammaglobulinemia (HGG) which has been previously seen     mostly in patients with primary immunodeficiency (PID).      The goal of treatment of HGG in PID has been to maintain the trough IgG level above 500 mg/dl     which might provide better protection against infections than do lower IgG serum     concentrations. Although IgG therapy is of substantial benefit, the doses and trough levels     of IgG that are optimal are not yet clearly established. The impact of high versus low IgG     dosing on the frequency and severity of infections and rejection has not been studied before     in LT patients with HGG. The specific aims for this study are to compare the incidence of     infections in lung transplant recipients receiving higher versus lower dose of SQ IgG and to     compare the incidence of infections in lung transplant recipients with mild     hypogammaglobulinemia versus normal IgG levels. This study will be a single center study of     all lung transplant recipients, age 18 years or older, at the University of Pittsburgh     Medical Center (UPMC), with a randomized treatment arm and an observational arm.      The hypotheses for the research study are:        -  Therapy with IV or SQ IgG is of substantial benefit in reducing the number of infections          in lung transplant recipients with severe hypogammaglobulinemia (IgG < 500)        -  A higher dose of SQ IgG, with subsequent higher trough IgG levels, may have a higher          impact on the frequency and severity of infections and rejection episodes, compared to a          lower dose of SQ IgG, with subsequent lower IgG trough levels        -  Lung transplant recipients with mild hypogammaglobulinemia ( IgG= 500-750) have a higher          incidence of infections compared to patients with normal IgG levels   "
146941|NCT01361165|"     We plan to analyze the data to meet the primary objective of the study:      To characterize the change in bone mineral density (BMD), as measured by lumbar spine DEXA,     during and following treatment with tenofovir DF-containing antiretroviral therapy in     HIV-infected children.      In addition, we plan to analyze the data to meet 2 secondary objectives of the study:        1. To study and monitor markers of bone metabolism - calcium, phosphorus, parathyroid          hormone (PTH), vitamin D levels, bone resorption markers (urinary collagen cross-linked          N-telopeptide and free deoxypyridinoline), bone formation markers (bone specific          alkaline phosphatase and osteocalcin) - in HIV-infected children treated with tenofovir          DF-containing antiretroviral therapy.        2. To study immunologic, virologic and clinical effects of tenofovir DF administered to          HIV-infected children in combination with other antiretroviral therapies.   "
146942|NCT01361152|"     The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of     prospective total knee arthroplasties performed in patients younger than fifty years of age     with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to     compare        1. functional scores        2. rates of radiographic failure        3. revision rates        4. survivorship   "
146943|NCT01361139|"     This is a study that seeks to characterize data obtained from patients with a variety of lung     diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound     instrument in the doppler mode (not the imaging mode used in examination of pregnant women     for instance) is placed on the chest wall and the unique software the investigators have     developed analyzes the signal reflected back from within the lung. On the basis of pilot     studies performed previously the investigators expect to receive different signals from     different diseases. The investigators seek to further characterize these signals to enable     accurate diagnosis of different lung diseases using our technology.   "
146944|NCT01361126|"     This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX     Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in     subjects who have previously received factor replacement therapy for hemophilia B. The study     consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5     month treatment period. Subjects will receive weekly routine prophylactic therapy and     on-demand treatment for bleeding episodes. In addition, subjects who are not on routine     factor replacement therapy prior to the study will receive only on-demand treatment for     bleeding episodes.   "
146945|NCT01361113|"     This study will be a single arm phase II clinical trial of 8 weeks of daily, oral     neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically     confirmed localized renal cell carcinoma (RCC).   "
147066|NCT01359267|"     The purpose of this study is to obtain preliminary information on the potential of 99m     Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.   "
147213|NCT01357343|"     This study is being conducted to compare the effectiveness of integrated chiropractic and     acupuncture care for the management of low back pain.   "
146946|NCT01361100|"     This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study     includes 2 steps. The first one aims to validate the algorithm defined at the time when the     test was developed in patients with different tumour stages. Patients will be enrolled before     any treatment. They will immediately undergo the test. No follow-up will be realized. In     total, 100 patients will be included in this first step. The estimated period of inclusion is     6 months.      If the algorithm is validated, the second step of the study will start. The purpose is to     determine the characteristics of the test. Enrollment will concern smokers and alcohol     drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract.     Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum     of one year. In total, 385 patients will be enrolled in this step during an estimated period     of 18 months.   "
146947|NCT01361087|"     Transforming Growth Factor Beta (TGF-β) is a protein that controls proliferation, cellular     differentiation, and other functions in most cells. TGF-β levels play a major role in the     pathogenesis of Marfan syndrome, a disease characterized by disproportionate height, long     extremities, lens dislocation in the eyes and heart complications such as mitral valve     prolapse and aortic enlargement increasing the likelihood of aortic dissection. While the     underlying defect in Marfan syndrome is faulty synthesis of the glycoprotein fibrillin I,     normally an important component of elastic fibers it has been shown that the Marfan syndrome     phenotype can be relieved by addition of a TGF-β antagonist in affected mice.   "
146948|NCT01361074|"     The aim of this study is to explore the differential efficacy of in vivo exposure versus     augmented reality exposure in the treatment of specific phobia (small animals).      The hypothesis is: There will not be significant statistical differences in the efficacy of     in vivo exposure therapy versus augmented reality exposure in the treatment of specific     phobia (small animals).   "
146949|NCT01361061|"     Hepatocellular carcinoma (HCC) is one of the tumors with a rising incidence worldwide. The     aim of this trial is to improve the detection of early HCC nodules in the liver. At the     moment screening for HCC in patients with liver cirrhosis is performed by ultrasound and     measurement of alpha- fetoprotein (AFP). In this trail the tumor markers AFP- L3 (a     subfraction of AFP) and Des-y- carboxyprothromib (DCP) are measured in addition in order to     receive information about the course of these markers before the detection of a HCC nodule.   "
146950|NCT01361048|"     The investigators are trying a combination vaginal product of higher dose metronidazole     combined with miconazole to see if it is effective in treating vaginal trichomonas.   "
146951|NCT01361035|"     What's the purpose of this study? This 4-year study is designed: (1) to teach primary care     physicians how to recognize low health literacy patients and effectively counsel them on     cancer screening using risk communication and shared decision making and (2) to assess the     impact of training on changes in physician communication behavior and changes in low health     literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis     that physician training in cancer screening guidelines, health literacy, and communication     skills will improve provider-patient interactions during encounters dealing with preventive     health maintenance especially cancer screening.      How will the proposed study be implemented? Thirty-two physicians in the New Orleans     metropolitan area will be recruited and randomly assigned to one of two groups. The unit of     randomization will be the health care organization or clinic. The intervention group will     receive training in health literacy, cancer screening, risk communication and shared     decision-making. The control group will not receive communication training until the end of     the study. Physicians in both groups will undergo three clinic visits with standardized     patients (actors trained to portray real patients; mystery shoppers) but they will not be     aware that they are conducting visits with actors. The visits will occur at study enrollment     and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate     the physicians' communication skills. Each physician assigned to the intervention group will     receive verbal feedback on communication skills from the standardized patients and complete a     web-based tutorial. Physicians in the control group will not have access to the web-based     tutorial until the end of the study.      For each physician, 10-15 patients with limited health literacy will be recruited to the     study. Each patient will rate his/her perceived involvement with care and global satisfaction     with care at study enrollment and annually for three years. Age and gender-appropriate     referral rates for breast, cervical and colorectal cancer screening and patients' receipt of     such screening will be assessed annually for three years. All study physicians, regardless of     group assignment, will receive performance feedback (report cards) on their cancer screening     rates among low health literacy patients in their clinic.   "
146952|NCT01361022|"     The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm     Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration   "
146953|NCT01361009|"     This is an open-label, multicenter, non-interventional, prospective observational study. we     collect the safety information of pramipexole over 12w treatment. Parkinson disease patients     with different severity who have already used pramipexole could be observed in this study. In     the whole observation period, treatment decision was determined by physician and patient     completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient     withdraw, laboratory test.   "
146954|NCT01360996|"     The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder     characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal     gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS     effectively reduces circulating androgens. Although OCs are the most common and one of the     oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular     menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of     PCOS women with different body mass index (BMI) are limited. This study is being done to     compare the hormone and metabolic changes after treatment with low-dose oral birth control     regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with     different body weights.   "
146955|NCT01360970|"     Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability     to induce protective immunity in immunosuppressed travellers are scarce. The investigators     assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis     (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).   "
146956|NCT01360957|"     The purpose of this clinical trial is to study the therapeutic effect of black cumin water     extract (Nigella sativa L.) on obesity and overweight   "
146957|NCT01360944|"     The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a     Psoriasis Plaque Test (PPT).   "
147056|NCT01359410|"     The investigators propose a randomized, controlled trial of stapled pancreatic transection     versus mesh reinforced stapled pancreatic transection. For the duration of the study period,     participating surgeons will utilize a standardized staple technique. Either a reabsorbable     polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium     (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the     test group. In order to have a uniform test method, the investigators will utilize a     laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple     size (4.8mm).   "
146958|NCT01360931|"     Lung cancer is the leading cause of cancer death in Hong Kong. Lung adenocarcinomas is the     most common type, accounting for 70% of lung cancer and the molecular target of epidermal     growth factor receptor (EGFR) gene mutation at exons 18 - 21 is present in about 50% of lung     adenocarcinomas. The v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations     are commonly present in the other 50% that are EGFR wildtype. EGFR and K-ras mutations are     found to be mutually exclusive in the same tumor. EGFR-tyrosine kinase inhibitor (TKI) can be     used as treatment for EGFR mutated tumors while no specific targeted therapy can be     recommended for EGFR wildtype tumors and these patients often receive chemoirradiation, which     is toxic and clinical response is suboptimal. There is a need to find alternative molecular     pathways/targets in EGFR wildtype lung adenocarcinomas.      Even with EGFR mutations, good clinical response to EGFR-TKI is achieved in about 70% of     these patients. This would mean suboptimal targeting of the EGFR gene or the presence of     alternative pathways mediating tumor progression and susceptibility to therapy. Exploration     of molecular pathways in lung cancer may allow for discovery of new molecular targets for     therapeutic development.      Neutrophil infiltration is frequently observed in lung cancer. Recognized similarities     between neutrophils and cancer cells include (i) ability to circulate as single cells; (ii)     target attachment via vascular system; (iii) target invasion. The major difference is that     migrated neutrophils will undergo apoptosis while cancer cells can escape apoptosis.      This led to the postulation that neutrophils and cancer cells may share similar inflammatory     cascades by secreting a similar panel of proteases, and one of these could be neutrophil     elastase (NE). Animal studies demonstrated that NE from neutrophils moves into lung tumor     cells and mediates lung tumor growth via degradation of Insulin receptor substrate-1 (IRS-1),     leading to activation of intracellular phosphoinositide-3-kinase (PI3k) and the v-akt murine     thymoma viral oncogene homolog 1 (Akt) signaling pathways and the intracellular tyrosine     kinase of the platelet-derived growth factor receptor (PDGFR).      The aims of this study are to demonstrate NE activities and the subsequent signaling cascades     activated in lung cancer cells, and to verify NE and its related pathway activation in     clinical lung cancer specimen.      This study will conclude the roles of NE and the therapeutic potential of NE/IRS-1/PI3K/PDGFR     pathways in EGFR wildtype lung adenocarinomas.   "
146959|NCT01360918|"     Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a     superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal     atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac     surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is     beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the     concomitant treatment of AF. The investigators aim to establish the effectiveness of     incorporating epicardial pulmonary vein isolation into elective cardiac surgery.   "
146960|NCT01360905|"     The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA     approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre     term labor.   "
146961|NCT01360892|"     This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements     will predict prospectively the incidence of hepatocellular carcinoma, the incidence and     severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C     patients.   "
146962|NCT01360879|"     This is a multi-center cross-sectional study in which the Real-time Tissue Elastography®     measurements will be collected prospectively from patients with chronic hepatitis B or C     virus presenting for liver biopsy.   "
146963|NCT01360866|"     To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in     addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major     Depressive Disorder (MDD)   "
146964|NCT01360853|"     The question being asked in this study is: Will patients with advanced pancreatic cancer live     significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na     than if they are treated with Gemcitabine alone? There are two parts to this study. In the     first part of the study, patients with metastatic pancreatic cancer who have received no     prior chemotherapy for this disease will be assigned by chance either to the group that will     be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group)     or, to the group that will be treated with Gemcitabine only (about 50 patients will be in     this group). How long patients survive in the 2 groups will be compared. If it looks like     there is no difference between the groups, the study will stop. If it looks like patients in     the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study     will continue into a second part where more patients will be treated in order to confirm and     better understand the findings of the first part of the study.   "
146965|NCT01360840|"     The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD     525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free     survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic     castrate-resistant prostate cancer (mCRPC).   "
146966|NCT01360827|"     The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a     novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin     and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell     carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the     dose levels.   "
146967|NCT01360814|"     This randomized clinical trial studies structured multidisciplinary intervention or standard     medical care in improving quality of life (QOL) in patients receiving active cancer     treatment. A structured multidisciplinary intervention may improve the QOL in patients     receiving treatment for cancer. It is not yet known whether structured multidisciplinary     intervention is more effective than standard medical care in improving QOL   "
146968|NCT01360801|"     The investigators seek to test the hypothesis that the improved version of high definition     white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual     Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments     than current versions of these endoscopes.   "
146976|NCT01360450|"     Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines     to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive     care units. While the use of these agents are undisputedly beneficial in reducing pain and     anxiety, improving ventilation, reducing pulmonary vascular resistance and improving     outcomes; the consequence is often the development of tolerance and physiologic dependence -     similar to prenatal exposure from these same classes of drugs. The investigators have     recently reported the results of randomized placebo control trial showing that the addition     of clonidine (central alpha 2 agonist) to tapering doses of opioids was efficacious and safe     in treating opioid dependence in infants who had moderate to severe neonatal abstinence     syndrome from prenatal drug exposure to opioids. Currently, the investigators propose to     perform a double-blind, randomized placebo control trial in a cohort of critically ill     infants without prenatal drug exposure at Johns Hopkins Hospital to test the overall     hypothesis that early addition of clonidine to a cohort of critically ill neonates on     mechanical ventilation who are receiving opioids and benzodiazepines for analgesia and     sedation will be efficacious and safe in reducing both the incidence and severity of     withdrawal symptoms (NICU-NAS); as well as, reducing the time to complete sedative and     analgesic drug detoxification. The hypothesis will be tested by addressing 2 specific aims     that will determine: 1) the efficacy and safety of clonidine in critically ill infants, and     2) pharmacokinetics and pharmacodynamics using population-based pharmacokinetics in this     vulnerable infant population who have only been exposed to these drugs as part of their     routine care. Many standard of care practices are incorporated in neonatal and pediatric     care prior to evidence based studies. This proposal will fill a much needed gap in     translating what the investigators have learned about basic mechanisms mediating dependence     and withdrawal to proven therapies for vulnerable pediatric populations.   "
146969|NCT01360788|"     Recently integrated in clinical practice, the Global Initiative for Chronic Obstructive Lung     Disease (GOLD) classification states that a mild (stage I) chronic obstructive pulmonary     disease (COPD) is present, in a smoker, when the postbronchodilator forced expired volume in     1 second (FEV1) to forced vital capacity (FVC) ratio is < 0.7. A major change that was     introduced by the GOLD classification system was that COPD could be diagnosed despite an FEV1     that is within normal predicted values (above 80% predicted). Because it suggests diagnosing     and detecting COPD earlier than done until very recently in medical practice, the GOLD     standards bring in a new reality to clinicians. In fact, this novel COPD classification comes     with new research challenges because the functional impacts and systemic consequences related     to COPD are mostly documented in patients with moderate to severe stages with little     information specifically in GOLD stage I COPD. This information is important if the     investigators are to convince physicians that GOLD stage I COPD needs to be diagnosed and     eventually treated.      The investigators aimed to characterize GOLD stage I COPD patients according to     activity-related dyspnea. More specifically, our objectives were to compare:      i) baseline pulmonary function ii) exercise capacity iii) quadriceps muscle function iv)     levels of physical activity in daily life      between symptomatic (Sx) GOLD stage I COPD patients, asymptomatic (ASx) GOLD stage I COPD     patients and healthy control subjects (CTRL). The investigators reasoned that exercise     tolerance and physical activity levels would be decreased in Sx GOLD stage I COPD patients as     it would be similar between ASx GOLD stage I COPD patients and CTRL.   "
146970|NCT01360775|"     Objective: To assess the effect of a nutritional educational intervention on the risk of     malnutrition dependent patients aimed at the caregivers.      Material and methods:      Intervention study with control group, with 200 patients randomized selected, in a Home Care     Program of 5 Primary Care Centers, malnourished and dependents, older than 65 years and with     a caregiver.      Socioeconomic and cultural characteristics of the patient and the caregiver are collected.     Mini Nutritional Assessment (MNA), food intake, anthropometric and serum parameters of     nutritional status: albumin, prealbumin, transferrin, hemoglobin, lymphocyte count, iron,     ferritin, are evaluates on 0- 6-12 months. Also evaluated dentures, basic activities of daily     living (Barthel test), cognitive state (Pfeiffer test) status of mood (Yesavage test).      Prior to the intervention, the educational procedure and the design of educational material     are standardized among nurses. The nurses make an initial session for caregivers and     monitored the education at home monthly (4 visits) up to 6 months. NANDA (NORTH AMERICAN     NURSING DIAGNOSIS ASSOCIATION) specific methodology of the Nursing profession is used. The     investigators studied the effect of the intervention on the caregivers on the patient's     nutritional status by the MNA test, diet, anthropometry and biochemical parameters.      Bivariate normal test statistics and multivariate models were created to adjust the effect of     the intervention.      The program SPSS / PC was used.   "
146971|NCT01360528|"     Therefore preterm infants must need folic acid replacement than term babies.   "
146972|NCT01360515|"     This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety     and tolerance.   "
146973|NCT01360502|"     This is a prospective study designed to assess safety and potential influence of the MiroCam     on cardiac pacemaker and implantable cardiac defibrillator.   "
146974|NCT01360476|"     This project seeks to reduce the disparity in hypertensive heart disease which exists for     African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure     (BP). The investigators are targeting a highly vulnerable, often neglected subject population     which stands to benefit tremendously from better BP control and a corresponding decrease in     heart damage. HTN occurs early in life and more often in African-Americans, reducing both     quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency     department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency     disproportionately affects African-Americans. Vitamin D is thought to play an important role     in cardiovascular health. Vitamin D replacement in those who are deficient has been thought     to reduce the cardiovascular disease, especially if initiated early before irreversible     damage has occurred, but this has yet to be tested in a prospective clinical trial.     Accordingly, this proposal was designed to investigate the relationship between vitamin D and     cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of     African-American, vitamin D deficient hypertensive patients without prior history of heart     disease.      The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in     vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which,     if shown to be effective could improve the existing approach to a widely accessible,     cost-effective option.   "
146975|NCT01360463|"     According to UNAIDS, Indonesia is experiencing one of the most rapidly expanding HIV/AIDS     epidemics in Asia. The epidemic in Indonesia has been fueled by injection drug use among     heroin users and the national response includes the scale-up of methadone maintenance     treatment.      Drug counseling is considered to be an integral part of methadone treatment, but few studies     have been designed to assess its benefits and costs. In settings such as Jakarta, data     regarding the costs and benefits of drug counseling have critical public heath relevance.      The investigators propose to conduct a prospective randomized trial to evaluate the efficacy     of integrated drug and HIV counseling among injecting drug users. This study will be     conducted at six methadone clinics in Jakarta, Indonesia where the HIV prevalence among     injecting drug users ranges between 50- 86%, with collaborators from the Drug Dependence     Hospital in Jakarta, the University of Pennsylvania and Yale University. The specific aims of     this four year study are to evaluate the impact of Behavioral Drug and Risk Counseling     (BDRC)—a low intensity, cognitive behavioral approach that integrates drug counseling and     risk reduction intervention. Those assigned to the BDRC arm will be compared to those who     receive treatment as usual which includes an initial risk reduction intervention and     counseling as needed. The investigators hypothesize that the structured, low intensity BDRC     approach will be more cost effective and result in higher rates of retention in treatment,     lower rates of drug use and lower rates of HIV risk.      To test these hypotheses, the research team in Jakarta will recruit 300 injecting drug users     as they enter treatment at the Drug Dependence Hospital and its five satellite programs.     Following informed consent procedures, research staff will randomize participants to either     the BDRC intervention or to treatment as usual. All subjects will be fuly assessed at     baseline and months 3, 6, 9, and 12.      The proposed work will be build on collaborations that have been established with the     Indonesian Investigator Adhi Nurhidayat,MD during his NIDA INVEST Fellowship at University of     Pennsylvania when he spent time with David Metzger, PhD and George Woody, MD. It will also     extend findings from a WHO study on substitution therapy of opiates and HIV/AIDS that was     completed by Riza Sarasvita, MS,MHS (former NIDA Humphrey Fellow at Johns Hopkins University)     and her colleagues at The Drug Dependence Hospital Jakarta, Indonesia.   "
147067|NCT01359254|"     The primary objective of this study is to assess the rate of engraftment with combined     haploidentical-cord blood transplantation in patients with pre-existing donor specific     antibodies and in those with active disease.   "
147231|NCT01357109|"     The purpose of the study is to investigate if oral treatment with bosentan improves     endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.   "
146977|NCT01360437|"     This is a single-center, randomized, single-blind, investigator-initiated pharmacological     study with a crossover design. Patients with acute coronary syndrome (ST-elevation myocardial     infarction, non-ST elevation myocardial infarction, unstable angina) and presenting high     on-clopidogrel platelet reactivity as assessed with the VerifyNow assay (platelet reactivity     units PRU≥235) 24 hours post percutaneous coronary intervention (PCI), will be randomized     after informed consent in a 1:1 ratio to either prasugrel 10mg/d or ticagrelor 90mg twice a     day for 15 days. Platelet reactivity assessment will be performed at Day 15±2 days and then a     crossover directly to the alternate treatment group for an additional 15 days period, without     an intervening washout period will be carried out. Patients will return at Day 30±2 days for     platelet reactivity assessment.   "
146978|NCT01360424|"     The purpose of this study is to analyse efficacy of teriparatide treatment in patients with     new forms of inherited low-turnover osteoporosis.   "
146979|NCT01360411|"     In this single centre study we study the use of endoscopic ultrasonography (EUS) combined     with elastography in order to separate malignant tissue from benign tissue in and adjacent to     the upper gastrointestinal tract.   "
146980|NCT01360398|"     The aim of this study is to generate epidemiological data to further explore determinants of     Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral     pathogens to Acute Exacerbation of COPD (AECOPD) episodes.   "
146981|NCT01360385|"     Recent studies have shown a remarkably positive effect of 6 monthly injections of Ranibizumab     on eyes with CRVO. The disease may cause severe sight threatening complications, partly due     to restrictions in blood flow and oxygenation . Although Ranibizumab has been shown affective     to reduce oedema of the retina, it is not known whether the drug ameliorates or aggravates     restrictions in oxygenation.      The Oxymap oximeter allows a non-invasive measurement of the oxygen saturation in retinal     vessels and thus the state of retinal oxygenation.      The primary objective of the study is to evaluate the effects of injections of Ranibizumab on     the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion     (CRVO),      The secondary objective is to evaluate the effects of injections of Ranibizumab on visual     acuity and retinal oedema in eyes with different degree of ischemia.   "
146982|NCT01360372|"     It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates)     in patients will result in increased tube feeding rates with more frequent nutrition at goal     calorie rate.   "
146983|NCT01360359|"     The purpose of this randomized clinical trial of low back pain exercise programs is to     determine if trunk control can be changed by core stabilization exercises. The proposed     mechanism of pain reduction and functional improvement of core stabilization exercises is     that it enhances trunk movement and muscle control. This study will provide preliminary     evidence of the link between patient outcomes and treatment mechanisms.      The investigators hypothesize that:        -  both treatment groups will demonstrate significant improvements in pain and function;        -  only subjects in the core stabilization group will demonstrate significant improvements          in trunk movement and muscle control.   "
146984|NCT01360346|"     Recent studies suggest the employment of 'conscious' sedation (1) for critically high - risk     patients (2), showing more efficacy then deep sedation (3). The investigators want to compare     intravenous injection versus enteral sedative drugs administration, purposing to maintain a     'conscious' sedation level compatibly with the needed cares, invasive procedures, and medical     and nursing surveillance.   "
146985|NCT01360333|"     When subjected to fluid loss or fluid deficiency irrespective of disease or environmental     factors it is discussed how to rehydrate or how to hydrate prophylactic.      In medical care it is common to give infusions. However it has increasingly become common to     hydrate the patient through the mouth even early after bowel surgery. Moreover it is more     simple to provide energy the natural way.      Which fluid to give, depends on several factors such as possibility to drink, the volume and     emptying of the stomach as well as the fluid absorption in the bowel.      The provided fluid can also influence this process depending on temperature,     osmolality/tonicity and composition (carbohydrates or salts).      In this study we wish to study the speed with which the provided fluid is absorbed by the     bowels and how fast the fluid is distributed to the different body compartments depending on     it's composition.      The three fluids will be either tap water, high sodium chloride and a carbohydrate rich     fluid.   "
146986|NCT01360320|"     This is a randomized, placebo controlled, multicentric trial to investigate the effect of     diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG),     the major polyphenol of green tea, on the recurrence of colon adenomas.   "
146987|NCT01360307|"     The Clinically Useful Depression Outcome Scale (CUDOS) is a brief, self-administered     instrument that not only evaluates depressive symptoms but also both functioning and quality     of life. The assessment of patients´ perspective may provide valuable information that could     be lost if relaying only on clinician evaluation. The purpose of this study is to achieve a     psychometric validation into Spanish of the CUDOS scale in patients with major depression     disorder in a primary care setting.   "
146988|NCT01360294|"     The aim of this study is to develop a patient reported outcome tool specific to small airways     disease, which assesses symptoms and signs of small airways disease and may help in addition     to FEF50% to discriminate between asthmatic patients with and without small airways disease.   "
146989|NCT01360281|"     The purpose of this study is to compare the efficiency of neuromuscular electrical     stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and     on recovering motor function of patients with knee osteoarthritis.   "
147040|NCT01359618|"     This is a two part study. Part A will determine the maximum tolerated dose of TC-5214     administered to healthy male subjects in single ascending oral doses. This part of the study     will define the highest dose of TC-5214 to be administered in Part B. Part B of this study     will investigate the effect of TC-5214 on the electrical activity of the heart following     single oral administration. The study will be carried out healthy male subjects in a four     period crossover study with TC-5214 compared to placebo and oral moxifloxacin as a positive     control. The safety, tolerability and pharmacokinetics of TC-5214 will also be evaluated.   "
147041|NCT01359605|"     The purpose of the study is to characterize the metabolism and excretion (ADME) of a single     oral dose of [14C]varespladib methyl.   "
146990|NCT01360268|"     Rationale for this study:      Correction of hypocholesteremia and insulin resistance after successful eradication of HCV by     combination therapy of interferon and ribavirin has been shown in several studies. The     majority of these studies examined genotype 1 and some genotype 3 patients, but it is not     clear if the same results can be achieved in other genotypes of HCV.      Moreover, clinical data of the relationships between different adipocytokines, metabolic     profiles, and HCV and treatment is of value to further understand the mechanisms for     HCVrelated metabolic alterations. The present proposal is designed to address the paradox of     HCV-related metabolic alterations/adipocytokine alterations and to determine how BMI     influences the HCV-related metabolic alteration/adipocytokine aterations by collecting and     analyzing the samples from humans with HCV infection prior to and after combination of     peginterferon alpha-2b plus ribavirin      For metabolic alternations:      Lipid profile: After treatment, responders in both genotype I and II will experience more     increase of cholesterol levels and LDL levels than nonresponders/ relapseres. Insulin     resistance: After treatment, responders with both genotype I and II will experience more     decrease of HOMA-IR than nonresponders/ relapseres; higher percentage of responders will     achieve HOMA-IR < 2 than nonresponders/ relapseres B. For adipocytokine alternation, this     study is more of exploratory propose as there is still little well established consensus.   "
146991|NCT01360255|"     Hepatocellular carcinoma (HCC) is one of the tumors with an increasing incidence worldwide.     Often treatment possibilities are limited and only palliative treatment such as a     transarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three     months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker AFP     ( alpha-fetoprotein) is elevated, but not all patients show this elevation. In the last years     new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin (DCP) have     been examined. In this clinical trial the course of these markers are examined after TACE in     order to receive hints if the patient will be a therapeutic responder.      Furthermore the investigators are interested in the quality of life after TACE. Patients     receive a questionnaire with regard to the quality of life before and 3 months after TACE.   "
146992|NCT01360242|"     In the setting of primary Percutaneous Coronary Intervention (PCI), the investigators     hypothesize that a 24-48 hour delay strategy of stenting after successful thrombus aspiration     and establishment of Thrombolysis In Myocardial Infarction (TIMI)-3 flow with optimal     antithrombotic therapy may decrease the risk of MicroVascular Obstruction (MVO) as assessed     by Cardiac Magnetic Resonance Imaging (CMRI).   "
146993|NCT01360229|"     This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can     safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will     receive either real or sham acupuncture twice weekly for six weeks.   "
146994|NCT01360216|"     The purpose of the study is to measure whether an education and training intervention for     clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will     result in greater use of the methods among contraceptive patients.   "
146995|NCT01360203|"     The purpose of this study is to compare the effect of implementing wireless remote monitoring     combined with structured telephone monitoring, versus current care, on variation in     rehospitalization among older patients hospitalized with heart failure at six medical     centers.   "
146996|NCT01360190|"     The overall goal of this proposal is to study quantitative electroencephalography (QEEG ) as     a method for the detection of antidepressant treatment response. The investigators have     developed a QEEG algorithm called cordance that appears to provide much the same     information about brain function as PET or SPECT scanning, and has shown patterns of brain     function that appear to be indicative of depression. Of greatest interest is that these     patterns appear to normalize in response to antidepressant treatment.   "
146997|NCT01360177|"     This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT     pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS     [Na+I- symporter, sodium iodide symporter] and demonstrate radioiodide uptake on 124I PET/CT     scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a     cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid     irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25     to 100 mCi.   "
146998|NCT01360164|"     The Hereditary Ataxias are a group of genetic disorders characterized by slowly progressive     incoordination of gait and often associated with poor coordination of hands, speech, and eye     movements. Current treatments for Hereditary Ataxias are mainly pharmacological,     rehabilitative, or psychological treatments，while no effective treatment available. Stem Cell     therapy is a novel and promising therapeutic strategy for Hereditary Ataxias treatment. In     this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells     transplantation will be evaluated in patients with Hereditary Ataxias.   "
146999|NCT01360151|"     This is a prospective, comparative control analysis. The investigators want to evaluate the     aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal     vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic     therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.   "
147000|NCT01360138|"     Ligamentum flavum in the cervical region is thin or not fused at the midline. The     investigators inferred that the size and elasticity of the ligamentum flavum, in combination     with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in     some patients. If so, the investigators hypothesized that the paramedian approach would be     advantageous for finding cervical epidural space more easily during cervical epidural steroid     injections (CESIs).   "
147001|NCT01360125|"     RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the     laboratory may help doctors predict how well patients will respond to treatment.      PURPOSE: This research study studies biomarkers in samples from patients with newly diagnosed     acute myeloid leukemia treated with cytarabine-based chemotherapy.   "
147064|NCT01359306|"     The purpose of this study is to determine the predictors of right ventricular damage (RVD)     assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement     (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI)     and its prognostic significance.      The investigators hypothesize that ischemia related changes of the myocardium are also     visible in the right ventricle and that they have an impact on patient outcome.   "
147002|NCT01360112|"     A vaccine which interrupts malaria transmission is a critical tool to achieve the ultimate     goal of eradication of this disease. Transmission blocking vaccines work by inducing antibody     in vaccinated individuals that inhibits the development of malaria parasites in the mosquito,     thus interrupting the cycle of transmission to the next human host. Efficacy of these     vaccines may be estimated by in vitro membrane feeding assays using immune sera and     laboratory strain mosquitoes, but these assays need to be qualified to determine to what     extent they are predictive of transmission blocking in the field. Clinical trials of     transmission blocking vaccines are also anticipated and have started in this community. This     protocol will use a nested casecontrol cohort design to compare results of mosquito feeding     assays in a malaria exposed population in Bancoumana and surrounding villages in Mali.     Households will be identified using census data and individuals will be consented for     participation. Malaria smears will be obtained at monthly visits, and gametocytemic     individuals will be asked to participate in direct feed experiments using insectary-raised     mosquitoes. Infectivity in these mosquitoes will be compared against those of mosquitoes fed     in membrane feeding assays in Mali and the USA. Data will also be obtained on gametocyte and     parasite carriage rates through the year. A total of 250 volunteers from Bancoumana, ages 3     months to 50 years, were initially enrolled in 2011. In 2012, an additional 250 adults from     Bancoumana were enrolled and participants older than 5 years of age who were enrolled in 2011     and wanted to continue participation were re-enrolled into the study. A transmission blocking     vaccine trial started in May 2013, and has enrolled participants from this adult cohort in     that study. Up to 50 new adults from Bancoumana and surrounding villages will be enrolled in     2014 and those volunteers previously enrolled into the study over theage of 5 years old will     be offered re-enrollment into the study.   "
147003|NCT01360099|"     Background:      - Osteoporosis is a condition where the bone becomes more brittle and more likely to break as     a person ages. The drugs that people take to treat this condition have prevented many common     hip fractures. But these drugs may be associated with problems in the shape and structure of     the hip bone after many years of use. These changes in the hip bone may lead to an unusual     kind of hip fracture. These fractures are very rare, so it is hard to study them. Researchers     want to learn more about these fractures.      Objectives:      - To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for     several years, those who have just started taking them, and those who have never taken these     drugs.      Eligibility:        -  People at least 50 years of age who have been taking osteoporosis drugs for at least 5          years.        -  People at least 50 years of age who have been taking these drugs for less than 1 year.        -  People at least 50 years of age who have never taken these drugs.      Design:        -  All participants will have three total visits over 3 years.        -  At the first visit, those taking part will have a medical history and physical exam.          They will complete a questionnaire about medication use and bone health. They will also          have an x-ray of the hips and pelvis, and have a bone density scan (the kind used to          test for osteoporosis) of the hips.      Those in the study will repeat these exams and medical history questions at followup visits.     These visits will take place 18 months and 36 months after the first study visit.        -  At any of these visits, participants who may have a hip fracture that does not show up          on the x-rays will have an imaging study to examine the bone more closely.        -  Participants who receive a hip replacement or suffer from a broken bone at any time          should inform the study researchers as soon as possible.   "
147004|NCT01360086|"     RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin     calcium, work in different ways to stop the growth of tumor cells, either by killing the     cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.     Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving     more than one drug (combination chemotherapy) together with cetuximab before surgery may make     the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving     these drugs after surgery may kill any tumor cells that remain after surgery.      PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin,     and leucovorin calcium together with cetuximab and to see how well they work in treating     patients with adenocarcinoma of the stomach or gastroesophageal junction.   "
147005|NCT01360073|"     The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary     death associated with use of monotherapy low dose ASA (single antiplatelet) as well as     concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in patients     with serious coronary heart disease using two UK primary care databases.   "
147006|NCT01360060|"     Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia     in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an     effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of     magnesium in parturients undergoing Cesarean section.   "
147007|NCT01360047|"     The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary     death associated with use of monotherapy low dose ASA (single antiplatelet) as well as     concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time     users of low dose ASA for secondary prevention using a UK primary care database.   "
147008|NCT01360034|"     The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin     as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).   "
147009|NCT01360021|"     This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the     Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.   "
147010|NCT01360008|"     Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation     will be investigated in a cohort study design in experienced electrophysiologic (EP) centers     analyzing propensity-matched cohorts.   "
147011|NCT01359995|"     The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients     with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan     University hospital.   "
147012|NCT01359982|"     The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001     for injection in subjects with advanced solid tumors or lymphomas for which there are no     currently accepted curative therapies. This study will also conduct an exploratory evaluation     of objective tumor response using CT or MRI.   "
147013|NCT01359969|"     This open-label study is being conducted to confirm the safety, pharmacokinetic profile and     efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema     attacks in patients, from 2 up to and including 13 years of age.   "
147014|NCT01359956|"     This study evaluated two chemotherapy regimens with and without the addition of interferon in     patients with advanced or recurrent melanoma.   "
147015|NCT01359943|"     The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous     (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo,     followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite     treatment with Methotrexate.   "
147016|NCT01359930|"     The study is to primarily measure safety and interactions between oral doses of     Naltrexone/Bupropion and i.v. Methamphetamine.   "
147017|NCT01359917|"     The hypotheses of this study were that:        1. HIV lipodystrophy is associated with psychological morbidity relating to body image,          anxiety and depression.        2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or          Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical          volume of treated areas.        3. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D          volume.   "
147018|NCT01359904|"     Background:      Type II diabetes is a disease that affects more than 246 million people worldwide. Most     importantly, one of the complications of type II diabetes is kidney damage and this has lead     to many patients seeking hemodialysis treatment, a type of kidney replacement therapy.     However, during hemodialysis treatment, many patients are greatly at risk for having their     blood sugar drop below normal and this can lead to neurological problems. Also, it has been     reported that hemodialysis patients who have poorer control of blood glucose levels are at     risk to developing heart problems. It has been shown that adding 5.5 mmol/L of glucose in the     hemodialysis treatment can reduce the chances of having an abnormal decrease in blood glucose     levels. Currently, some institutions use 10 mmol/L of glucose (instead of 5.5 mmol/L) in the     hemodialysis treatment, however, there is little documented support to justify for this     action.      Objective:      The investigators are would like to explore the effects of use of 10 mmol/L of glucose in     hemodialysis treatment and to determine if it worsens control of blood glucose levels, both     during the treatment sessions and over the long term in type II diabetes patients. Also,     patients on hemodialysis are prone to infection, so we will also observe if there is any     change in infection rate among these patients with increased glucose in the treatment.      Methods:      The study will consist of 40 patients who will be randomly split into 2 groups. One group     will be treated with 5.5 mmol/L glucose in the hemodialysis treatment and the other group     will have 10 mmol/L glucose in the treatment. During the hemodialysis treatment, patient     blood glucose will be measured at set intervals to check for any acute drops in glucose     levels. Also, to assess long-term control of blood glucose levels, each patient will have 2     blood tests, one at the start and another at the end of the experiment. Signs of infection     will be checked at the start of each session. Each patient will remain in their group for the     duration of the study, which is 12 weeks.   "
147019|NCT01359891|"     The protein ST2 is a member of the interleukin-1 receptor family. Blood concentrations of the     soluble isoform of ST2 (sST2) are increased in inflammatory and heart diseases and are     considered a prognostic marker in both. The Presage™ST2 assay was recently shown to meet the     needs of quality specifications of laboratory medicine. Soluble urokinase plasminogen     activator receptor (suPAR) levels reflect inflammation and elevated suPAR levels are found in     several infectious diseases and cancer. Both sST2 and suPAR have recently been introduced as     sensitive biomarkers for patients with septicemia. Both may be promising or even superior     alternatives to currently established sepsis markers leading to an improvement of outcome in     patients with septicemia. However, a clinical study which clarifies kinetics of values over     time/possible correlation with causative pathogen/progress/deterioration of septic patients     is urgently needed before these biomarkers can be established in clinical routine.      Primary study objectives To clinically evaluate sST2 and suPAR in patients with bacteremia     /septicemia. To correlate results with causative bacterial organisms, response to or failure     of antiinfective treatment, severity of clinical status as well as outcome.      To study the kinetics of the test results and to correlate the sST2/suPAR results with other     well established infection markers (e.g. C-reactive protein, procalcitonin, blood counts).      Natural endpoints of the study will be patient's death or complete recovery.      This is an explorative study. To meet the objectives both novel biomarkers will be clinically     evaluated in a cohort of 500 in-patients with septicemia at the University Hospital Graz.     Starting the day a patient's blood culture turned positive the investigators will collect     samples every 12h within the first two days and then every 24h.Measurement of sST2 and suPAR     values will be done retrospectively. To analyze clinical sensitivity/specificity of the novel     biomarkers sST2 and suPAR as prognostic factors for development of bacteremia/septicemia, a     second cohort consisting of 250 in-patients will be investigated in a longitudinal matter.     Patients without a previous positive blood culture test during the current episode of disease     for which blood cultures are ordered by a physician will be included and sST2 and suPAR     levels will be determined from samples taken simultaneously with this first blood cultures.   "
147020|NCT01359878|"     Severe maternal bleeding is a serious complication of birth and causes 125.000 deaths     worldwide each year. The investigators aim to investigate if early treatment with fibrinogen     concentrate versus saline can reduce the incidence of blood transfusion in women with     postpartum haemorrhage.      A low level of fibrinogen has been associated with increased blood loss and transfusion     requirements in different clinical settings including obstetrical bleeding. Early up-front     treatment with fibrinogen may reduce incidence of transfusion by securing optimal haemostatic     capacity in women with postpartum haemorrhage.      The investigators plan to enrol 245 patients on four hospitals in the Capital Region of     Denmark during a two year period.      As safety measure the investigators plan to use TEG®/Functional Fibrinogen/Rapid-TEG as     haemostatic monitoring of all participants during the trial: Baseline test is taken at     inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken     immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the     providers of treatment - the rest is clinically available.   "
147021|NCT01359865|"     To compare analgesia and orthopedic rehabilitation milestones in patients receiving either     spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with     lumbar plexus block.   "
147022|NCT01359852|"     The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult     volunteers.   "
147023|NCT01359839|"     The goal of this research is to evaluate whether group therapy combining Relaxation Response     (RR) training and Cognitive Behavioral Therapy (CBT) in a group format merits further     investigation in the treatment of Major Depressive Disorder (MDD). Specifically, the primary     aim of this waitlist-controlled study is to gather preliminary data evaluating the     effectiveness of RR-CBT group as treatment for patients with current MDD or a history of MDD,     including patients who continue to be depressed despite taking antidepressants and patients     who choose not to take antidepressants due to the fear of side effects and/or for personal     reasons.   "
147024|NCT01359826|"     Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting the     physical, social, psychological health and quality of life of patients. Fatigue and pain are     aspects of SLE patients which affect their health related quality of life (HRQOL). The     purpose of this study is to determine the effect of milnacipran on fatigue in SLE patients     with widespread pain (WSP) or fibromyalgia syndrome (FMS). A secondary objective will be to     determine the effect of milnacipran on pain and quality of life measurements. Fifty SLE male     and female patients, 18 years and older, will be recruited for a 15-week study, in which     patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo.     Measurements of fatigue, pain, and HRQOL will be compared between the milnacipran and placebo     groups at the screening visit, baseline visit, week number 6, and week number 14. Milnacipran     has been shown to be an effective treatment for pain, fatigue and physical function in FMS     patients. To date, no clinical trials have demonstrated efficacy for the treatment of fatigue     in SLE patients with concomitant WSP or FMS. The investigators hypothesize, based on FMS     studies, that the milnacipran treated patients will have less fatigue than those in the     placebo group. In addition, compared to control arm, those treated with the study drug will     have less pain and improved quality of life.   "
147055|NCT01359423|"     Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in     the treatment of long (≥80 mm) femoropopliteal artery lesions.      Study design :        -  Prospective, randomized, multi-center study        -  A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who          meet all inclusion and exclusion criteria will be included.        -  Patients will be randomized in a two by two factorial manner according to the strategy          of stenting (long versus short stenting) and the additional use of cilostazol. Each          randomization of the enrolled subjects will be done 1:1.        -  Patients will be followed clinically for 1 year after the procedure.        -  Angiographic or CT follow-up will be performed at 1 year.   "
147025|NCT01359813|"     Patients with cirrhosis present an increased susceptibility to bacterial infections.     Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe     circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is     a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP     infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal     failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However,     little is known regarding the effect of albumin administration in patients with non-SBP     infections. Two recent prospective studies demonstrated that non-SBP infections are     associated with impairment of the effective circulating volume and precipitate renal failure     whatever the presence of ascites.      The aim of this randomized clinical trial is to evaluate the effects of albumin, associated     with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and     survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and     presenting with a Child-Pugh score > 8.   "
147026|NCT01359800|"     Tat is a key HIV regulatory protein produced very early after infection, prior to virus     integration, and necessary for viral gene expression, cell-to-cell virus transmission and     disease progression. Previous studies in natural HIV infection, indicated that the presence     of a Tat-specific immune response correlates with a lower incidence and reduced risk of     progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune     response to Tat may exert a protective role and control the progression to AIDS in vivo.      On the basis of the above mentioned consideration, the present study was directed at     investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African     patients.   "
147027|NCT01359787|"     The purpose of this study is to evaluate the efficacy and safety of three concentrations of a     development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).   "
147028|NCT01359774|"     The purpose of this study is to identify and quantify a brain energy deficit in Huntington     patients, using 31P-RMN spectroscopy.   "
147029|NCT01359761|"     This study will implement and empirically evaluate the efficacy of a cognitive behavioral     intervention program, titled, Post Admission Cognitive Therapy(PACT), for military service     members and beneficiaries [with Veterans expected to be added] admitted for inpatient care     due to severe suicide ideation and/or a recent suicide attempt.   "
147030|NCT01359748|"     The purpose of this trial is to determine the accuracy of the Blood Pressure (BP) measurement     of multifunction KEITO devices under test requirements of the Standard American National     Standards Institute(ANSI)/Association for the Advancement of Medical     Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO     81060-2:2009.   "
147031|NCT01359735|"     This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs     surgery.   "
147032|NCT01359722|"     The purpose of this study is to determine the possible effect nephroprotective of     N-acetylcysteine in patients with chronic kidney disease undergoing elective coronary artery     bypass grafting by serial evaluation of renal function and to evaluate whether treatment     reduces cardiac mortality, cardiac events and Global mortality, if it interferes with     oxidative stress and inflammation and the need for dialysis.   "
147033|NCT01359709|"     Cigarette smoking is an important public health concern, and it is most often initiated in     adolescence. Despite substantial research on smoking cessation in adults, however, relatively     little effort has focused on therapeutic approaches to reduce adolescent smoking.      Behavioral interventions, such as contingency management (CM), and pharmacotherapies, such as     nicotine replacement therapy (NRT), each have some efficacy in reducing adolescent smoking,     and in adults, combination of behavioral and pharmacological approaches is more effective in     reducing smoking than either one alone. Little is known about combining these therapeutic     approaches in adolescent smokers, and research in this area has been hindered, in part, by     the expense and complexity of large-scale clinical trials of the combined treatments and the     relative dearth of a cost-effective laboratory procedure. Developing and validating a     laboratory model to evaluate the combined effects of CM and pharmacological adjuncts for     adolescent smoking is important because such studies can be conducted more rapidly and     efficiently, and could provide information on the optimal conditions (e.g., dose) under which     pharmacotherapies might augment the positive effects of CM.      The investigators propose to conduct a randomized, placebo-controlled, double-blind,     between-groups, 2-week laboratory study. Participants will be randomly assigned to one of the     following four groups: CM+nicotine patches, CM+placebo patches, noncontingent control     (NC)+nicotine patches and NC+placebo patches. Fifteen participants will be enrolled in each     of the four groups, totaling 60 participants. On day 1, participants will arrive to the     laboratory for a 1-h session. During this session, breath carbon monoxide (CO) levels, saliva     or urinary cotinine levels will be evaluated. Participants will also complete questionnaires     on craving, withdrawal and cigarette dependence. Participants will then receive seven     patches, to wear for seven days, one patch daily. Five sessions during the days 8 to 12 will     serve as CM or noncontingent sessions, and participants will continue wearing patch daily. On     these sessions, breath CO levels will be evaluated, and participants will have opportunity to     receive payments based on their CO levels, according to the group assignment. If successful,     the proposed study will provide a human laboratory model for use in studies of the combined     CM and pharmacological approaches for modifying adolescent smoking behavior.   "
147034|NCT01359696|"     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with     and without gemcitabine.   "
147035|NCT01359683|"     The purpose of this study is to investigate non-linear heart rate variability indexes as     predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery,     including coronary artery bypass graft (CABG) and valvular surgery.   "
147036|NCT01359670|"     This study, supported by Parent Project Muscular Dystrophy, will determine if tadalafil or     sildenafil can improve muscle blood flow during exercise in boys with Duchenne muscular     dystrophy.   "
147037|NCT01359657|"     The purpose of this study is to determine 1) the safety and tolerability of multiple     intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the     maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or     Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.   "
147038|NCT01359644|"     The purpose of the study is to determine whether therapy with the combination of PSI-7977 and     daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus     (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response     with undetectable HCV RNA 12 weeks post treatment   "
147039|NCT01359631|"     Hypothesis:      Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological     parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter.      Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological     parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel     diameter.   "
147042|NCT01359592|"     RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride,     vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by     killing the cells or by stopping them from dividing. Radiation therapy uses high-energy     x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer     growth in different ways. Some block the ability of cancer cells to grow and spread. Others     find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled     monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and     carry cancer-killing substances to them without harming normal cells. Comparing results of     diagnostic procedures, such as PET scan and CT scan, done before, during, and after     chemotherapy may help doctors predict a patient's response to treatment and help plan the     best treatment.      PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating     patients with limited-stage diffuse large B-cell lymphoma.   "
147043|NCT01359579|"     The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and     the safety of varespladib methyl in mild or moderate renal impairment patients and healthy     volunteers.   "
147044|NCT01359566|"     To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo     for the treatment of spasticity in subjects with multiple sclerosis (MS).   "
147045|NCT01359553|"     The purpose of this study is to clarify the potential of intra-articular ultrasound imaging,     non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and     arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and     compared with the arthroscopic findings.   "
147046|NCT01359540|"     This study compares the change in bone density which occurs after hip replacement with     different femoral stem devices.   "
147047|NCT01359527|"     This study compares the change (loss) of bone mineral density (BMD) that occurs in the     proximal femur after hip resurfacing and total hip replacement.   "
147048|NCT01359514|"     Mechanism-based choice of therapy for neuropathic pain:      Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain     modulation profile?   "
147049|NCT01359501|"     This is a two-year double blind, placebo-controlled, and randomized clinical trial, which is     aimed to evaluate the effects of Chinese medical treatment on leucopenia after chemotherapy     in breast cancer patients.   "
147050|NCT01359488|"     The purpose of this research study is to determine the safety and tolerability of up to five     doses of VRS-317 in Adult Growth Hormone Deficient patients.        -  Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes          from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and          bone turnover (bone alkaline phosphatase)        -  Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3)          will be determined by standard model independent methods based on the plasma          concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg,          AUC0-inf, and t1/2.        -  The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range          (for appropriate age/gender) for IGF-I levels in adult patients for up to one month          after administration of a single dose   "
147051|NCT01359475|"     Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly     broken down primary teeth since 1950. They are generally considered more expedient to place     than large multi-surface amalgam or composite restorations and have a longer life. They have     been used successfully in clinical practice for many years and have presented little in the     way of adverse events. The major drawback is the poor esthetics along with lingering concerns     over potential health hazards associated with the nickel content. Several attempts have been     made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and     occlusal surfaces and substituting composite resin for the entire crown, but to date none of     these approaches have been very successful.      Acetal resin has been used in a number of applications in medicine and dentistry, and     recently has met with early success when tested as a substitute for stainless steel crowns.     It has a number of excellent physical and mechanical properties including a low coefficient     of friction, good wear resistance, high fatigue resistance, good impact strength and     resistance to creep.      The purpose of this trial is to compare the clinical performance of preformed acetal resin     crowns and preformed stainless steel crowns.      2.0 OBJECTIVES      The objective of this study is to compare the clinical performance of acetal resin crowns     with preformed stainless steel crowns when used to restore primary molar teeth.   "
147052|NCT01359462|"     For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics,     pharmacology, and safety of the drug under fasting condition.   "
147053|NCT01359449|"     The purpose for this study is to demonstrate the safety and immunogenicity of two doses of     Menactra® administered between 12 and 18 months of age and concomitantly with routine     immunization with two different provincial schedule      Primary Objectives:        -  To describe the immunogenicity of Menactra® administered concomitantly with routine          immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants          (measured by serum bactericidal assay using baby rabbit complement [SBA-BR])        -  To describe the immunogenicity of MenC administered concomitantly with routine          immunizations at 12 months of age (measured by SBA-BR)      Secondary Objectives:      Safety        -  To describe the safety profile of Menactra® and MenC vaccines after each dose when given          concomitantly with routine immunization.      Immunogenicity        -  To describe the immunogenicity of both vaccines using serum bactericidal assay using          human complement [SBA-HC]        -  To describe the immunogenicity of Pediacel administered at 18 months.   "
147054|NCT01359436|"     The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor     for specific EGFR mutation detection in clinical specimens of NSCLC patients, the     investigators conduct a prospective clinical study. In comparison with results from direct     sequencing of EGFR, the investigators evaluate the performance of e- Ab sensor, including     reproducibility, sensitivity, specificity, and cross-reaction (such as detection of EGFR     mutations other than L858R and DelL746-A750). The potential factors which may interfere with     the results would be investigated. With such technique, the investigators can obtain EGFR     mutation information of NSCLC patients in cost-saving and time-saving way and can offer more     individualized treatment for the investigators patients.   "
147057|NCT01359397|"     Background: It is estimated that in the Netherlands each year approximately 900 patients with     gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for     chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have     shown that survival and quality of life are prolonged with chemotherapy. However, no     chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore,     tolerability of treatment and ease of administration (outpatient compared to inpatient) are     important considerations for the development of novel treatment schedules. Study design: This     is an open-label, multicentre, phase II trial designed to evaluate the efficacy and safety of     bevacizumab in combination with docetaxel, oxaliplatin and capecitabine chemotherapy (B-DOC)     as first-line therapy in patients with inoperable locally advanced or recurrent and/or     metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In case of HER2     positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the     stomach or gastro-oesophageal junction trastuzumab is added to this regimen (B-DOCT).      Study Endpoints:      Primary endpoint Progression free survival defined as the time measured from B-DOCT study,     Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first     progression or death. Secondary endpoints Toxicity Overall survival, defined as the time from     registration to death Response rate defined as the percentage of partial and complete     responses Duration of response defined as time from response to first progression     Translational research on pharmacogenomic and biological factors that may predict treatment     response.   "
147058|NCT01359384|"     The purpose of the clinical trial is to gain a more substantial understanding of bronchial     inflammation in patients with severe primary immundeficiency under immunoglobulin therapy. It     is intended to characterize the systemical such as the bronchial inflammation (IL-1, IL-2,     IL-6, IL-8, IL-17, TNF-a, NFkB, IFN-gamma, TGF-beta, TLR2 und TLR4)in children with severe     immune deficiency in order to generate new treatment strategies based on the results.      The methods being used for characterization purposes within this trial include specific lung     function tests ( spirography, bodyplethysmographie w. helium) such as the analysis of eNO and     eCO. Furthermore, sputum and serum samples are being analyzed by quantitative real-time     polymerase chain reaction (PCR),(qRT-PCR) and by cytometric bead assay (CBA). Components of     the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant     proteins) are genetically determined from sputum or blood respectively. In the conduct of the     study the investigators will retrospectively and systematically evaluate the available     high-resolution computed tomography (HRCT) studies of affected patients.   "
147059|NCT01359371|"     The purpose of this study is to evaluate the peer telephone cessation counseling that has     been and continues to be implemented at the Ann Arbor VA as part of the Tobacco Tactics     intervention.   "
147060|NCT01359358|"     This project has as general objective to determine if there is any Methicillin-resistant     Staphylococcus aureus (MRSA) strain disseminating in the hospital of Belo Horizonte. If this     is the case, the investigators will determine if this is an international known strain by     typing it by PFGE and MLST.      The detection of mecA gene will be performed by PCR. Their susceptibility profile to several     drugs will also be accessed and it will be possible to compare the response to those drugs     commonly in use to that of Daptomycin, a new drug available in Brazil.      It will be screened for reduced susceptibility to vancomycin by Macromethod Etest (MET) in     order to search for VISA or hetero-VISA. Also, due to the discussions at the literature about     mutations in genes that are said to be responsible for reduced susceptibility to vancomycin,     the investigators will sequence these genes in all PFGE type strain of this study looking for     mutations already described to compare to the screening results.   "
147061|NCT01359345|"     Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with     severe renal failure mainly in patients under dialysis in whom gadollinum is being used.      The investigators will evaluate the prevalence and severity of NSF in patients with different     degree of renal failure whom underwent imaging with Gadolinum.   "
147062|NCT01359332|"     Status EPILEPTICUS (SE) is a major medical emergency. The incidence per 100,000 population     has been estimated at 9.9 episodes in Europe and 41 episodes in the US. The overall morbidity     and mortality associated with convulsive SE (CSE) is 60% at three months. The alteration of     functional prognosis of these patients is more conventionally attributed to the cause than to     CSE itself. Longer seizure duration, progression to refractory status EPILEPTICUS and     presence of cerebral insult are strong factors independently associated with a poor     functional outcome. These three factors offer may be amenable to improvement and hope for     preventive strategies. Current guidelines recommend the use of anticonvulsant treatment whose     goal is prompt cessation of clinical and electrical seizures. None of these treatments has     demonstrated NEUROPROTECTICE property. Therapeutic moderate hypothermia (between 32 and 34 °     C) showed interest in neuroprotection of post anoxic coma patients after a cardiovascular     arrest on ventricular fibrillation by reducing morbidity and mortality in about 20% without     major side effects. This technique has been used successfully in various pathologies such as     stroke or traumatic brain injury. Pathophysiological mechanisms involved in epileptogenesis     and neurotoxicity induced by persistence of seizures can be blocked by therapeutic     hypothermia. Recent work on experimental models of SE demonstrated neuroprotective and     anticonvulsant interest of therapeutic hypothermia. Therapeutic hypothermia has also been     successfully used in some cases of particularly refractory CSE. Its early use in patients     with SE would have a double interest: neuroprotective and anticonvulsant. There is currently     no published studies or ongoing to determine the interest of its early use in patients with     CSE.   "
147063|NCT01359319|"     Hereditary Inclusion Body Myopathy (HIBM) is a severe progressive metabolic myopathy caused     by a defect in the biosynthetic pathway for sialic acid (SA), a critical component of many     muscle proteins, resulting in a deficiency in SA in the muscles of HIBM patients.      The effective replacement of the missing SA substrate is theoretically simple, and, in animal     models, replacement with SA showed significant restoration of sialylation biochemistry and     excellent reduction in muscle disease. These data show that replacement can achieve     significant clinical benefit in muscle pathology, function, and survival.   "
147068|NCT01359241|"     The main objective of this study is to evaluate the efficacy and safety of 24 hours of     closed-loop glucose control compared with standard diabetes treatment, in patients with type     2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied     as it is representative of patients with glucose dysregulation.   "
147071|NCT01359202|"     This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres.     Patients coming to the emergency department with bleeding in the brain not due to trauma or     other known causes who can be treated within 6 hours of onset will undergo CT angiography     using standard CT scanners (CAT scan). Those with a spot sign, a type of marker on the CT     scan that shows the brain is still bleeding, will be randomly assigned to a single injection     of factor 7(a blood clotting drug used in hemophilia) or placebo (inactive saline);     patients without a spot sign will not be treated. The researchers will look at how much     bleeding happens after the treatments are administered, as well as clinical outcomes such as     death and disability. The researchers think that factor 7 will cause the bleeding to stop     faster and possibly decrease death and disability.   "
147072|NCT01359189|"     This is a feasibility, exploratory, and proof-of-concept study to evaluate rectal probe     scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent     (ProstaScint®) in patients with suspected primary prostate cancer. ProxiScanTM is a small     cadmium zinc telluride (CST)-based compact gamma camera the size of a trans-rectal ultrasound     (TRUS) developed by Hybridyne Imaging Technologies, Inc.To explore the adjunctive     benefit/feasibility of PSMA distribution in the normal prostate versus prostate cancer gland     utilizing TRUS and CT/SPECT hybrid imaging, biopsy negative patients will be considered as     normal controls. Prostate cancer sextant biopsy histology results will be correlated with     ProxiScanTM, TRUS, and pelvis planar and SPECT/CT. Our hypothesis is that it will be safe and     feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific     ProstaScint® uptake in primary prostate cancer.   "
147073|NCT01359176|"     Capnography is the non-invasive monitoring of the concentration or partial pressure of carbon     dioxide (CO2) in the expired respiratory gases; it is thus a non-invasive monitoring     technique which allows fast and reliable insight into ventilation, circulation and     metabolism. The capnogram is a direct monitor of the inhaled and exhaled concentration or     partial pressure of CO2, and an indirect monitor of the CO2 partial pressure in the arterial     blood. The purpose of this study is to create a waveform library by collecting CO2 waveform     data from healthy volunteers.   "
147074|NCT01359163|"     A pivotal study to determine bioequivalence between a the current marketed formulation of     Femulen tablets and reformulated Femulen tablets in healthy female subjects.   "
147075|NCT01359150|"     A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response     Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid     Arthritis receiving CP-690,550 with and Without background Methotrexate   "
147076|NCT01359137|"     This is a Cochise County experiment with innovative probation supervision practices. Subjects     are assigned to one of three supervision conditions.   "
147077|NCT01359124|"     The primary objective is to evaluate water based treadmill exercise, land based treadmill     exercise, and upright cycling in meeting American College of Sports Medicine exercise goals     for moderate exercise.      The secondary objective is to compare exercise tolerance for water based treadmill, land     based treadmill, and upright cycling in meeting American College of Sports Medicine exercise     goals for moderate exercise.      The tertiary objective is to evaluate quality of life improvements for water based treadmill     exercise, land based treadmill exercise, and upright cycling.   "
147078|NCT01359111|"     The purpose of this study is to evaluate whether an investigational vaccine delivery device     (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the     skin.   "
147079|NCT01359098|"     The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3%     Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of     Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7     days.   "
147080|NCT01359085|"     Arthroscopic rotator cuff (RC) repair is often associated with severe post operative pain and     discomfort. Many analgesic protocols have been proposed for pain relief following RC repair     and controversy remains regarding the optimal postoperative analgesic protocol. Despite     significant advancement in analgesic techniques over the last decades 50-70% of patients who     undergo surgical procedures still experience moderate to severe postoperative pain.     Postoperative pain has both inflammatory component (i.e. related to traumatic tissue damage     and inflammatory reaction due to the surgical incision and procedure) and neuropathic     component (i.e. related to over sensitization of the peripheral and central nervous system).     Opioids are commonly used for postoperative pain reduction, however their use is associated     with numerous adverse events and should be limited.      Regional nerve block techniques have been emerged over the past decade and have become a     standard of practice recently. Recent studies indicate that a single-dose interscalene     brachial plexus block (ISBPB) is effective in providing postoperative analgesia following     shoulder surgery, reduces the need for opioid medication, and has a very high success rates     (≥94%) and few major complications (≤0.4%). However, regional nerve blockade, including     ISBPS, has a frequent incidence of temporary postoperative neurological symptoms within the     first postoperative week (4 -16%), is technically demanding and might be time consuming.      Pregabalin (Lyrica) is an anticonvulsant drug with membrane stabilizing and anti-nociceptive     effects commonly used for neuropathic pain relief and anxiety disorder. It desensitizes the     presynaptic terminals of hyperexcited neurons in peripheral and central nervous system (i.e.     reduces the transmission of excitatory neurotransmitters including glutamate, norepinephrine,     substance P, and calcitonin gene-related peptide) by reducing calcium influx through     high-voltage-activated calcium channels containing the alpha2/delta subunit. Pregabalin is     rapidly absorbed from the gut with bioavailability of approximately 90%, achieves peak plasma     concentration approximately 1h after administration, has half-life of about 6h and is     eliminated by renal excretion. Many studies over the past decade have evaluated pregabalin     roll in the treatment of acute postoperative pain. Pregabalin effect in reducing opioid     consumption and opioid adverse events (AEs) has been well established. Its analgesic effect     on acute postoperative pain remains questionable, and further studies are still required to     compare pregabalin analgesic potential with other standard post-operative analgesic regimens.     Pregabalin doses used in previous studies ranged from 75 to 600 mg given as a single dose     1-2h preoperatively with or without additional doses at 12h and 24h postoperatively. Doses of     150 mg and higher seemed to offer better results in terms of postoperative analgesia and     opioids sparing. However higher doses were associated with higher rate of AEs, mainly     sedation, dizziness and visual disturbances.      Nervous system desensitization by oral medication (e.g. pregabalin) rather than by invasive     means (e.g. ISBPB) may reduce adverse reactions, increase patient satisfaction and save     valuable time in the operation theater. To the investigators knowledge no previous study has     compared the efficacy of pregabalin to ISBPB for acute pain relief following arthroscopic     shoulder surgery. The investigators hope to contribute to the discussion regarding the     optimal pain relief method following arthroscopic shoulder surgery.   "
147081|NCT01359072|"     -  Approximately 30% of all patients with cancer report levels of psychological distress          indicative of the need for psychological intervention.        -  Research suggests that learning more adaptive coping strategies improves psychological          adjustment to cancer.        -  It is imperative to develop cost-efficient, feasible psychosocial interventions.        -  The aim is to test the efficacy of the self administered format of a psycho-educational          intervention (NUCARE) in reducing distress and enhancing adaptive coping strategies for          cancer patients.      It is hypothesized that:        -  patients would show significant reductions in distress (i.e., depression and anxiety)          over the 6-week treatment period, and that treatment would produce superior results          compared to wait-list; patients would maintain or even increase their improvement up to          3 months following treatment.        -  the treatment would enhance more adaptive coping strategies.        -  greater self-reported adherence to the treatment/homework would be associated with          symptom improvement, more autonomous self-regulation and higher perceived competence for          adhering to the coping intervention program.   "
147082|NCT01359059|"     Hypothesis      No studies considered the comparison of preemptive vs. post-surgery Pregabalin (PGL) only     administration. The investigators believe that the administration of PGL preemptively would     diminish pain sensation and therefore the need for opioids administration in     orthopedic-oncologic patients more effectively than if administered starting postoperatively.   "
147094|NCT01358903|"     This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and     efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing     malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously     at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1     and/or 2, followed by RO5429083. For all patients there will be an option to continue     treatment with RO5429083 until disease progression or unacceptable toxicity occurs.   "
147095|NCT01358890|"     -  The primary aim of this study is to determine the adherence of low- carbohydrate among          Chinese.        -  Then compare the effect of low-carbohydrate and traditional Chinese but          restricted-calories diet on weight loss and metabolic traits.   "
147232|NCT01357096|"     The hypothesis of this project is to examine whether the integrated health care program as     the intervention group can reduce the recurrence and mortality of coronary artery-related     diseases than the traditional one as the comparison group.   "
147083|NCT01359046|"     Urinary catheters are used routinely in the postoperative care of urogynecology patients     after surgery involving the genitourinary tract. However, Urinary tract infections(UTI)     associated with indwelling catheter is the second leading cause of nosocomial infections. 20%     of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.      There are many different types of catheters available for use. Standard indwelling catheters     are made from a variety of materials including polyvinyl chlorine, plastic, plain latex,     polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer.     Specialized catheters have been developed with the aim of reducing infection. Strategies     generally involved coating the inner, outer or both surfaces of the catheter with     antimicrobial materials. These materials can be antibiotic or antiseptic with the most common     antiseptic material used being silver. Silver ions are bactericidal, are used safely when     applied topically to humans and used in controlling infections.      Previous studies comparing UTI rates in transurethral catheters have reported a significant     reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard     catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy     supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that     this study will show a statistically significant decrease in UTI rate among the individuals     with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.   "
147084|NCT01359033|"     The study aims to investigate the differences in survival trajectories and hospital     variability in myocardial infarction (MI) mortality rates in the UK and Sweden.   "
147085|NCT01359020|"     The purpose of this study was to compare the efficacy and tolerability of acetaminophen,     dipyrone and ibuprofen to fever control in children.      For the efficacy asses were compared:        -  the time to start the action;        -  the action duration;        -  the difference between the basal temperature and the lower temperature in the study          period.      For the tolerability asses all adverse events were recorded, as well as your intensity and     the relation to the treatment.   "
147086|NCT01359007|"     The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and     the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging     sufficient to allow surgical resection, could improve the overall survival of patients with     locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic     cancer, a phase II study of this regimen in patients with locally advanced unresectable and     borderline pancreatic cancer is planned to determine the rate of conversion to operability.   "
147087|NCT01358994|"     From a central registry at the National Board of Health and Welfare in Sweden collect all     patients in the city of Malmö prescribed metformin during two years. Glomerular filtration     rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control     material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU     admission were also sought. The study hypothesis is that metformin is prescribed to patients     with lower GFR than anticipated with very few cases of lactic acidosis registered.   "
147088|NCT01358981|"     This will be the first study in which LY2881835 is given to humans in order to evaluate the     safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the     body and its effect on blood sugar levels.      The study consists of two parts. In part A, healthy subjects will participate and in part B,     patients with type 2 Diabetes Mellitus (T2DM) will participate.   "
147089|NCT01358968|"     The purpose of this study is to assess the effect LY2603618 on a protein (enzyme CYP2D6)     which is involved in the metabolic pathway of Desipramine in patients with cancer. This is a     drug interaction study so the treatment of the disease will not be the main purpose of the     study.      The study involves two single doses of 50mg, 1 tablet by mouth, on Day 1 of Period 1 and 2.     In Period 1 Desipramine will be administered alone, In Period 2 Desipramine will be     administered in combination with LY2603618. LY2603618 will be administered as a 275mg IV     infusion over 1hr.      Desipramine will be administered at the end of the LY2603618 infusion. Information about any     side effects that may occur will also be collected.   "
147090|NCT01358955|"     -  There will be a significant difference in cognitive function between cognitive          intervention group (group therapy) and a wait list control group.        -  There will be a significant difference in cognitive function between a home-based          cognitive intervention group and a wait list control group.   "
147091|NCT01358942|"     This prospective observational study will evaluate the evolution of lung cancer related     symptoms and their correlation with the disease control rate (complete response, partial     response and stable disease) in patients with non-small cell lung cancer initiating     first-line treatment with standard platinum-based chemotherapy with or without Avastin     (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of     chemotherapy.   "
147092|NCT01358929|"     This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety,     tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive     multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8     weeks.   "
147093|NCT01358916|"     Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a     major driving force for the development of resistance. Thus optimization of antibiotic     prescription and reduction of unnecessary antimicrobial treatment are essential in the     prevention and reduction of antimicrobial resistance rates.      The goal of this study is the improvement of antibiotic prescription in outpatient care. The     study will take place within a Swiss-wide sentinel surveillance network of physicians. The     participating physicians will be randomised in a control and intervention group. The     intervention group will receive therapeutic guidelines for the treatment of upper and lower     respiratory tract infections and lower urinary tract infection as well as regular feed-backs     on the prescription pattern of the sentinel physicians during the past months. Sentinel     physicians will collect information about each antibiotic prescription, its indication and     characteristics of the patient.      Our hypothesis is that the prescription pattern in the intervention group will be optimised     and unnecessary antibiotic therapy will be reduced compared to the control group.   "
147907|NCT01348256|"     In this randomized multicentric phase II study, patients with colorectal carcinoma with     resectable hepatic metastasis will be randomized to treatment with dendritic cells or to     observation, following conventional treatment with surgery and chemotherapy.   "
147099|NCT01358838|"     Rationale: Scars can be highly disfiguring and may result in functional impairment and     psychosocial problems. Recently, fractional laser therapy (FLT) has been introduced as a     promising novel treatment modality for scars.      Objectives: The primary objective of this study is to assess the efficacy and safety of 10600     nm FLT for the treatment of different types of scars.      Study design: Prospective observer blinded randomised controlled split-lesion trial.      Study population: Thirty consecutive patients, aged at least 18 years, with hypertrophic or     atrophic scars who give written informed consent.      Methods: Two similar test regions of the scar will be randomly allocated to either 3 sessions     of FLT (UltraPulse Encore 10600 nm Total FX) with an interval of 4 weeks or no treatment.      Main study parameters/endpoints: Blinded Physicians Global Assessment is the main outcome     variable. Secondary variables are Patient's Global Assessment, blinded clinical assessment of     the scar on a scale from 0-3 (erythema, pigmentation, texture, hypertrophy, atrophy,     pliability), Patient and Observer Scar Scale (POSAS), objective colour measurements by     reflectance spectroscopy (LAB) and chromameter (erythema index, melanin index).      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: Subjects participating in the study will be requested to visit the SNIP     (Amsterdam) 3 times for treatment and 2 times for follow-up. The time investment per visit     will be 30 minutes for treatment sessions and 20 minutes for follow-up visits. FLT using a     10600 nm laser device is a minimally invasive laser procedure with FDA approval for both the     device (Lumenis Encore 10600 nm) and the indication (scar). Local side effects are erythema     (always; 1-2 weeks), oozing (often; 1-3 days), swelling (always, 1-4 days), blisters < 0.5cm     (occasionally) and blisters > 0.5cm (very rare). No systemic side effects are known for this     laser device.      All outcome measures involve non-invasive procedures. The laser treatment (FLT) requires     local anesthesia. The amount of topical anesthetic used for infiltration is low     (approximately 5% of the maximum dose) which minimizes the risk for local or systemic side     effects due to the anesthetic agent.      All together the burden due to the study is moderate, side effects are generally local and     mild. Systemic side effects are not reported with this treatment. There is an indirect     benefit for the participating subject. In case of improvement of the treated test regions,     this therapy can be directly utilized to treat the whole scar.      Considering the relative lack of alternative treatment options in many of these scars, the     balance between burden, possible side effects and prospect for improvement is very favorable.   "
147100|NCT01358825|"     The aim of this study is to assess antibody persistence in infants who received three doses     of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11     months of age in study NCT00307034.   "
147101|NCT01358812|"     The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in a     phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and     associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other RAS     rare mutations have been suggested as additional potential biomarkers for anti-EGFR agents in     metastatic colo-rectal cancer. The present study aims to demonstrate the feasibility and the     activity of the first-line combination of the GONO-FOLFOXIRI regimen and Panitumumab in     molecularly selected metastatic colo-rectal cancer patients.   "
147102|NCT01358799|"     The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay     for Chlamydia trachomatis (CT; ACT Assay), which is cleared for use on the TIGRIS DTS     (Direct Transfer) System (TIGRIS System), can be tested on the PANTHER System. The intended     use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER     System. ACT Assay performance on the PANTHER System is comparable to performance on the     TIGRIS System.   "
147103|NCT01358786|"     Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are     used for membership (between the aponeurosis of the abdominal flap and underlying muscles)     for closing the donor area, where there is reduced incidence of complications.   "
147104|NCT01358773|"     Obese adolescents are submitted to a multiprofessional weight loss program, which is formed     by doctors, nutritionists, physiotherapists, psychologists,and physiologists. The volunteers     have intervention 3 times a week during one year, where they practice exercises, have     nutrition and psychology counseling, and physiotherapy orientation. Once a month they have an     appointment with the doctor. The hypothesis of this study is that a multiprofessional therapy     is able to improve anthropometric and biochemical parameters, and also the quality of life of     obese adolescents.   "
147105|NCT01358760|"     The purpose of this Phase III trial is to evaluate the efficacy of intravaginal     dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.   "
147106|NCT01358747|"     All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is     hoped that patients will achieve a good response to both induction therapies consisting     either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide,     Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD     (Adriamycine, Bléomycine, Vinblastine, Décarbazine).      The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2)     in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc     therapy continuation to those patients who achieved only a partial response after 2     BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2     negative patients. For all patients included in the trial the achievement of a good response     to induction treatment will be checked after four cycles of induction treatment including a     centrally reviewed PET assessment      Patients will be randomized after verification of eligibility and before the start of the     protocol treatment.Patients will be randomly assigned to the standard treatment arm not     monitored by early PET, or the experimental treatment arm driven by the PET2 result.   "
147107|NCT01358734|"     The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential     azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed     acute myeloid leukemia (AML).   "
147108|NCT01358721|"     The purpose of this study is to evaluate the pharmacodynamic and biologic properties of     BMS-936558 in subjects with metastatic renal cell carcinoma.   "
147120|NCT01358552|"     This is an observational study in which patients who have been prescribed Néevo®/NéevoDHA®     are invited to participate in surveys about their pregnancy and experiences with     Néevo®/NéevoDHA®. The purpose of this study is to increase the understanding of the role of     L-methylfolate among patients who are candidates for Néevo®/NéevoDHA®, provide patients with     personalized education and support during their pregnancies, and contribute to the overall     understanding of the needs and concerns of women facing intermediate- to high-risk     pregnancies.   "
147197|NCT01357551|"     Obesity is the second leading cause of preventable deaths in the United States and is     associated with a wide range of diseases. In people who are obese, weight loss improves blood     pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for several     disease processes; increases physical functioning; and enhances health-related quality of     life. The current study evaluated a theoretically informed maintenance intervention. If     effective, this intervention could reduce the need for future clinic visits to treat obesity     and its many associated illnesses.   "
147111|NCT01358669|"     Although hip replacement surgery is a successful way of dealing with the pain and immobility     caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10     years. The main reason for this is the development periprosthetic osteolysis, that is, loss     of bone around the site of the hip replacement. The osteolysis is thought to be due to the     small particles of debris worn from the surfaces of the hip implant. These particles cause a     reaction in the blood cells around the joint which in turn affects bone cells and leads to a     loss of bone around the implant. The joint implant will then eventually become loose and     unstable, a condition known as aseptic loosening. At present the only way to treat aseptic     loosening is to have another operation to secure the hip joint, known as revision surgery.     Revision surgery is not always successful and exposes the patient to the risk of major     surgery.      In this study we explore the potential for giving a medication (denosumab) that may prevent     the loss of bone around the hip replacement implant. We will recruit patients who have been     listed for revision surgery. One group of patients will be given a single dose of denosumab;     another group will be given a placebo (dummy drug). At the time of the revision surgery a     small sample of the bone from around the hip replacement will be taken and examined under the     microscope. Comparisons will be made between the patients having the denosumab and those     having placebo to find out whether the denosumab is having a beneficial effect on the bone     surfaces. If successful, this study will lead to further studies to develop the use of     denosumab to prevent aseptic loosening.   "
147112|NCT01358656|"     Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20     years. However, data in the literature reveal that approximately 15-25% of patients     undergoing surgery still do not present optimal outcomes, which suggests that there is room     for improvement of the procedure. A possible explanation for this fact is that most ACL     reconstructions consider only one of the functional bundles of the ligament. Our hypothesis     is that the ACL reconstruction with the double-bundle technique will be effective in reducing     the patients' rotation of the knee joint for high-demanding tasks compared to the patients     who had ACL reconstruction with the single-bundle technique.   "
147113|NCT01358643|"     The purpose of this pilot is to assess the feasibility and potential effectiveness of three     specific e-health approaches. One approach, SparkPeople.com, involves the use of social media     and can be accessed through a free website. This approach has the potential to provide     support through an on-line community as well as a number of diet/weight and physical activity     related tools. A mobile phone application is also available for those with smart phones. The     second approach, BodyMedia, involves the use of an objective monitoring device that tracks     all activity. This information can be uploaded to a website to provide ongoing monitoring and     feedback about activity and energy expenditure. The third approach, P90X, involves a DVD     based resistance focused exercise program. While DVD programs are not necessarily considered     e-health, participants will be encouraged to participate in online community forums     associated with the program. All participants, regardless of randomization, will be given 4     point of decision prompts that are laminated 8.5x11 posters encouraging healthier behaviors     to display in various areas of their home.      The specific aims are:        1. To assess the effect of the intervention on weight, activity levels, depression, and          adherence.        2. To determine level of interest, perceptions, feasibility and satisfaction of the          proposed interventions (i.e. SparkPeople.com vs. BodyMedia vs. P90X) with particular          attention to: 1) social media; 2) food logs; 3) objective monitoring of physical          activity; 4) use of point systems   "
147114|NCT01358630|"     The purpose of this study is to analyze genetic polymorphisms in genes encoding     pro-inflammatory cytokines, and study the genetic predisposition to chronic periodontitis     (CP) in combination with atherosclerotic cardiovascular (ACD) and aneurysmal diseases. The     investigators will also try to identify oral bacteria in atherosclerotic plaques and     aneurysmal walls and thrombus. Histological analyses of atherosclerotic plaques and     aneurysmal wall will be performed.   "
147115|NCT01358617|"     This research study is studying biomarkers in tumor tissue samples from young patients with     neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may     help doctors identify biomarkers and learn more about biomarkers related to cancer   "
147116|NCT01358604|"     RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the     laboratory may help doctors learn more about changes that occur in DNA and identify     biomarkers related to cancer.      PURPOSE: This research study studies biomarkers in samples from young patients with     neuroblastoma.   "
147117|NCT01358591|"     The purpose of this study is to assess the effect of a high calcium breakfast on substrate     metabolism during exercise and appetite throughout the day.   "
147118|NCT01358578|"     This study will assess the safety and efficacy of secukinumab compared to placebo and     etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.   "
147119|NCT01358565|"     This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic     dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules.      An adaptive 2-stage study design will be implemented. Initially (Stage 1), a group of 9     subjects with moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive) followed by a     group of 9 healthy volunteer subjects with normal hepatic function who are comparable in age,     gender, and weight to the hepatically impaired subjects will be enrolled to receive a single     oral 20 mg dose of Fx-1006A each.      Data obtained from the first 2 groups will be analyzed and reviewed by the Sponsor to     determine whether Fx-1006A PK is altered by hepatic dysfunction. If it is determined that     hepatic dysfunction affects Fx-1006A PK, then Stage 2 will be commenced. During Stage 2, a     group of 9 subjects with mild impairment (Child-Pugh score of 5-6, inclusive) will be     enrolled to receive a single oral 20 mg dose of Fx-1006A each. Additional subjects with     normal hepatic function may be enrolled to ensure appropriate demographic matching to the     mild hepatically impaired subjects, with respect to age, gender, and weight.      During Screening, subjects will provide written informed consent to participate in the study     and be reviewed against the study entrance criteria (including assessment of hepatic     function) to determine eligibility. All subjects will provide blood and urine samples for     clinical laboratory testing, drug testing, and pregnancy testing to determine eligibility.      Subjects who meet the entrance criteria during Screening will check in to the clinical site 1     day prior to dosing (Day 0) in the evening, and will be reviewed against the entrance     criteria to confirm eligibility. Subjects will remain inpatient overnight for pre-dose     assessments. Subjects will be fasted for a minimum of 8 hours prior to dosing the following     day (water is allowed).      The single Fx-1006A dose will be administered on Day 1 under supervision of the Investigator     or appropriate clinical site staff. Subjects will remain fasted for 4 hours after dosing     (water is allowed) and will remain inpatient overnight for safety monitoring and PK sample     collection.      Subjects will be discharged on Day 2, after they have completed the study procedures and the     Investigator has determined that the subject is clinically stable. Subjects will return to     the clinical site for out-patient visits on Days 3, 4, 6, 9, 12, and 16 for safety     evaluations and PK sample collection. Day 16 will be the end of study visit.   "
147278|NCT01356498|"     This is an open-label extension phase of two double-blind, placebo-controled Phase 3     protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic     gout. The purpose of this study is to provide a continuation of treatment to subjects     completing the double-blind studies and obtain long-term safety and efficacy data.   "
147121|NCT01358539|"     Rationale: Although radiotherapy is an effective palliative treatment for patients with     painful bone metastases with over 70% responders, pain intensity is not always sufficiently     controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients     show that during weekly follow up, 35% of the patients remain above a pain intensity level of     4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO     criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline     'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain     control. However, the effect of a nurse-led education of patients undergoing palliative     radiotherapy for painful bone metastases has not been investigated yet.      Objective: This project investigates whether nurse-led pain education in addition to standard     care results in better control of pain in patients referred for palliative radiotherapy.      Study design: A national multicenter phase 3 study (n=450).      Study population: Patients with painful bone metastases referred for short schedule     radiotherapy.      Intervention: Patients will be randomized between standard care or standard care with the     Pain Education Program, a nurse-led pain education. The pain Education Program will be     provided on the same day the radiotherapeutic treatment will start. The nurse will first     assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will     be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses     will telephone patients at regular intervals during follow-up to monitor their needs.      Main study parameters/endpoints: The primary outcome of this randomized multicenter study is     a decrement of the number of patients whose worst pain intensity remains above 4 at any time     during the 12 weeks of follow up with regard to the control group. The secondary outcome is     improvement of quality of life.      Nature and extent of the burden and risks associated with participation, benefit and group     relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and     the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.   "
147122|NCT01358526|"     The primary objective of this study is to assess the efficacy and safety of OXN compared to     placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back     pain who require around-the-clock opioid therapy.   "
147123|NCT01358513|"     The aortic valve is the main outlet valve from the heart. This valve can become diseased and     narrowed when it needs to be replaced with an artificial valve. Currently, this is the     commonest reason for someone to undergo a heart valve operation in the UK. Unfortunately,     there are no medical treatments that can prevent or delay the progression of this disease     process. Here, the investigators propose to use new state-of-the-art imaging techniques to     better understand the disease process so that the investigators can effectively design and     assess potential new treatments. The ultimate aim is to stop this disease before patients     need to have surgery. In addition the investigators believe this technique will allow us to     predict the rate of progression of the disease   "
147124|NCT01358500|"     This study seeks to determine the suitable doses of fentanyl with acceptable adverse effect     and safety profile in opioid-dependent patients. The investigators anticipate that a well     tolerated dose of fentanyl which produces demonstrable analgesia will be found and will be     related to the patient's maintenance opioid dose.   "
147125|NCT01358487|"     The purpose of the study is:        1. to study whether individuals WHO ARE NOT CURRENTLY SERIOUSLY DEPRESSED will participate          in an online study to prevent clinical depression and        2. to estimate the percentage of participants who will complete online assessments at 1, 3,          and 6 months when receiving either a) email reminders + monetary online incentives or b)          email reminders + monetary incentives + phone calls.      NOTE: RECRUITMENT IS COMPLETED.   "
147126|NCT01358474|"     The purpose of this study is to determine if participants have changes in dopamine cells in     their brain using DaTSCAN™ brain imaging. Dopamine cell loss occurs in Parkinson's disease     (PD) and other degenerative Parkinsonian disorders, but does not occur in most other movement     disorders such as essential tremor or dystonia. DaTSCAN, which is also known as     123I-Ioflupane, is a new compound that has been developed by General Electric, Inc. and has     been approved by the US Food and Drug Administration (FDA) to help doctors detect changes in     dopamine. This test is performed by injecting DaTSCAN into a vein in the arm, and after a few     hours, a large amount of DaTSCAN temporarily accumulates in an area of the brain where there     are a lot of dopamine brain cells. Because DaTSCAN contains a small amount of radioactive     iodine, it allows doctors to use a special machine called single photon emission computed     tomography (SPECT) scanning to detect the location and amount of radioactivity in the brain     and help determine if there are changes in brain dopamine. It is hoped that this study will     help doctors detect the presence of dopamine changes even before symptoms are present. This     study will evaluate DaTSCAN in people with PD, those who are at risk for developing PD (e.g.,     those with idiopathic rapid eye movement sleep disorder (iRBD) and those who are heterozygous     or homozygous for Gaucher's disease (GBA) mutations) and those who are healthy volunteers.   "
147127|NCT01358461|"     Context      The investigators recently demonstrated a highly significant increase in muscarinic receptor     density in the myocardium of infants deceased from sudden infant death syndrome (SIDS)     compared to those of infants deceased from identified causes 1. Muscarinic receptor     overexpression was found in all SIDS samples studied to date. It was associated with an     average increase in acetylcholinesterase activity, appearing as a compensatory mechanism to     oppose the cardiac muscarinic receptor overexpression. Similar vago-cardiac abnormalities     were detected in a rabbit model of vagal hyperreactivity that the investigators first     described some years ago2. In these hyperreactive animals, expression of muscarinic receptors     was also enhanced in blood white cells. Noticeably, the pattern of changes in these cells     paralleled the pattern of changes in the heart. Thus, muscarinic abnormalities in cardiac     tissues could be inferred with high confidence from those measured in lymphocytes.This was     the first report of a vago-cardiac abnormality in sudden infant death syndrome. The     investigators findings also provided original and important perspectives for the     identification and therapeutic management of infants at risk of sudden death. As such, the     publication of the investigators work raised a major interest from the population and from     the scientific and medical communities, in particular cardio-pediatricians. ObjectivesThe     objective of the present clinical project is to validate, in human lymphocytes, muscarinic     receptor expression level (assessed by quantitative RT-PCR) as a circulating biomarker of     autonomic nervous system dysfunction and more specifically, of vagal hyperactivity and of     risk of sudden death. The project will include 2 major items, conducted in parallel:1.     evaluation of the muscarinic receptor expression in lymphocytes from adults with vagal     syncopes (n=60 patients from an existing file versus 60 controls) (Cardiology unit + Clinical     Investigation Centre (CIC) + Laboratory of Neurobiology and Cardiovascular Pharmacology); 2.     evaluation of the muscarinic receptor expression in lymphocytes from children with vagal     syncopes (n=60 versus 60 controls) (Pediatry unit + Clinical Investigation Centre +     Laboratory of Neurobiology and Cardiovascular Pharmacology).PerspectivesThis project     represents the first step of validation of a circulating marker of vagal hyperactivity and of     risk of SIDS in human. Once this step is completed, the investigators will start with the     prospective study  muscarinic receptor expression in lymphocytes and SIDS  (cord blood     collected at birth and follow up of the new-borns) (Maternity ward + CIC + Laboratory of     Neurobiology and Cardiovascular Pharmacology). Then therapeutic preventive management becomes     a realistic objective. A therapeutic clinical study will then be started with atropinic     drugs, in order to test their potential protective action against sudden death. The final     objective of the investigators research is the prevention of SIDS through i) identification -     as soon as birth - of new-borns at high risk and ii) appropriate prophylactic therapy. The     investigators work also opens exciting perspectives in the field of the still poorly     understood vagal disorders in children and adults such as vagal pauses.1 Livolsi et coll,     Plos One 5, e9464, 2010 ; 2 Livolsi et coll, Circulation 106, 2301-2304, 2002   "
147128|NCT01358448|"     In 2007 the Expert Committee published recommendations on the prevention and treatment of     childhood obesity. These recommendations outlined four interventions intended for advancement     based on the child's age, body mass index (BMI), and response to treatment. The initial     stage, Prevention Plus, is to be implemented in the primary care setting and focuses on     primary care providers monitoring growth monthly and delivering intervention messages that     target dietary and leisure-time behaviors that most contribute to energy imbalance in     children. Little research has evaluated the efficacy of these recommendations. Thus the     primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus     stage for treating childhood overweight and obesity in a primary care setting. As the cost of     interventions is a large barrier to the translation of evidence-based research into primary     care settings, a second goal of the project is to evaluate program cost-effectiveness.   "
147129|NCT01358435|"     The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30     with regard to its total and to its maximum serum insulin concentrations.   "
147168|NCT01357928|"     As part of a system wide reagent verification plan Haemoscope Corporation will be running a     study to verify the reference intervals of many of the reagents. Reference intervals will be     constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls     for a reference interval to be constructed from at least 120 donors. Some reagents currently     have ranges in place based on fewer donors than that stated in the guideline. This procedure     will provide additional testing results to meet the requirements outlined in the CLSI     guideline. Reagents that currently have no reference intervals will be tested and will     include a minimum of 146 donors.   "
147198|NCT01357538|"     This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of     Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.   "
147199|NCT01357525|"     The current study seeks to further investigate the impact of Stereotactic Body Radiation     Therapy following pancreatic resection with a close or positive margin. The investigators     hope to improve local control, and through the use of a shortened treatment schedule, allow     patients to begin systemic therapy earlier.   "
147130|NCT01358422|"     Research questions:        1. What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE)          associated with the use of dual anti-platelet therapy as compared with aspirin alone in          this population?        2. What is the absolute risk increase for clinically significant bleeding during the same          period associated with the use of dual anti-platelet therapy as compared with aspirin          alone in this population?      In brief the design of the study is as follows:        -  We will study patients undergoing non-cardiac surgery within four years of coronary          stenting.        -  We will record the anti-platelet agents taken by patients before, during and after          surgery.        -  We will record cardiac and bleeding events that occur whilst the patient is in hospital.        -  We will use the statistical technique of propensity scoring to match patients who have          similar risk factors and who received different anti-platelet regimens.        -  We will compare the incidence of cardiac events and bleeding in the matched groups.   "
147131|NCT01358409|"     Within large number of patients with obesity, it is crucial to determine who is at the     greatest risk for development of chronic heart disease. The investigators previous studies     suggest that an excessive accumulation of fat in heart cells precedes the development of     obesity-related pathologies and may serve as a biomarker of heart disease in high-risk     population. Until now, the evaluation of fat in the human heart was possible postmortem or by     biopsy. The investigators novel magnetic resonance spectroscopy technique enables the     quantification of intracellular lipid content non-invasively and repeatedly in humans in     vivo. It could be used to better screen and treat obese patients at risk for the development     of metabolic disease. The investigators hypothesize that in obese humans with elevated     myocardial triglycerides, treatment with Nebivolol will reduce myocardial fat and will     improve heart function.   "
147132|NCT01358396|"     Does diabetic patients' glycemic control affect their response to laser and/or intravitreal     injection therapy in terms of visual and anatomical outcomes.   "
147133|NCT01358383|"     This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult     volunteers.   "
147134|NCT01358370|"     This is a Natural History study to characterize key aspects of the clinical course of     lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.   "
147135|NCT01358357|"     This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study     designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or     divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without     rapid cycling and /or psychotic features.   "
147136|NCT01358344|"     The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high     percentage of drug as the free base are equivalent to tablets with the standard percentage     when given to participants.   "
147137|NCT01358331|"     This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given     as single agent oral therapy for participants with advanced solid tumors will be done into     two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum     tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2     dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants     with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to     see if MK-8353 is effective as single agent therapy.   "
147138|NCT01358318|"     The purpose of this study is to determine whether ingestion of a bar containing either added     soy protein or soy fiber or both, increases subjective and objective measures of satiety     compared to a control bar.   "
147139|NCT01358305|"     Soy protein is a high quality, plant-based protein that is comparable to milk, meat and eggs.     Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein (slow).     This intermediate rate may allow soy protein to have an extended window of muscle protein     synthesis that has not been monitored in previous studies. While most of the sports nutrition     recovery products are dairy-based protein blends (high in branched-chain amino acids), soy     protein offers additional benefits that can make an important contribution to these types of     sports nutrition products. Soy protein contains approximately 300% more arginine and 30% more     glutamine compared to whey protein and these two amino acids may bring additional benefits     (immunity and hydration, respectively) to athletes. A blend of high-quality proteins (soy     and dairy) may be the optimal sports nutrition product for athletes to consume following     training.   "
147140|NCT01358292|"     Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for     extra-articular tibial fractures treated with Smith& Nephew's Trigen META intramedullary     nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee     flexion) and Group B=with the semi-extended surgical technique. (2*100 patients)      Research Objectives:      The primary research objectives are to evaluate:      i) anterior knee pain and ii) the nail position and overall fracture alignment      Outcome Measures:        1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.        2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by          means of Patient questionnaires        3. Knee-related adverse events        4. Overall fracture alignment   "
147141|NCT01358279|"     This study is conducted to investigate the therapeutic efficacy and safety of transcranial     direct current stimulation (tDCS) over the primary motor cortex of patients with acute     migraine attack.   "
147142|NCT01358266|"     The purpose of this study is to evaluate the safety and efficacy of intravitreal injections     of DE-109 ophthalmic solution.   "
147143|NCT01358253|"     The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined     with chemotherapy in CD20+ adult acute lymphoblastic leukemia.   "
147144|NCT01358240|"     This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle     in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week     study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will     also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for     blinding purposes only.   "
147145|NCT01358227|"     The purpose of this study is to determine the side effects and best weekly dose of PR104 in     patients with advanced solid tumors.   "
147146|NCT01358214|"     Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a     TiLOOP® TAPE surgical mesh for stabilization of the urethra.   "
147147|NCT01358201|"     The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are     fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and,     consequently, the results of treatment are substantially lower. Additionally, elderly     patients tolerate the drugs considered relatively low-key in the management of the LAL and     suffer more toxicity. Although the LAL is much more common in patients over 60 years of age     than in younger adults, older adults with ALL are clearly underrepresented in prospective     controlled studies. A good portion of elderly patients are not able to tolerate the intensity     of the standard treatment applied to children or young adults and a significant portion of     them receive only palliative or supportive treatment. The data in the literature relating     specifically to the elderly population are scarce and most of them have obtained a     stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date,     the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients     because this protocol less aggressive than those used in high-risk ALL. However, the     development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a     relatively common type of LAL in the older patient, requires a differentiated treat these     patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol     has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a     significant benefit in survival related to the reduction of treatment (removal of the     L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a     reduction in toxicity   "
147148|NCT01358188|"     Gaucher disease (GD), the inherited deficiency of the lysosomal enzyme glucocerebrosidase is     characterized with accumulation of abnormal lipid in cells of the immune system, called     macrophages. Lipid engorged macrophages, then become activated, and are also called Gaucher     cells. The mechanisms leading to macrophage activation is not fully known, however several     findings in individuals with GD, such as non-specific inflammation,clinically resembling a     rheumatic disease with an increased sedimentation rate, joint pain, and extreme fatigue, in     addition poor wound healing, and a predisposition to diabetes may suggest an inappropriately     functioning immune system in GD. The pathways leading to macrophage activation could be     related to the accumulation of lipid metabolites or through the effects of other immune     cells. In this study, immunologic profiling and functional assays will be performed in     peripheral blood samples from patients with GD. The identification of the immunologic basis     of GD will lead to the the development of new disease markers and different treatment     options.   "
147149|NCT01358175|"     This study will assess the efficacy and safety of secukinumab in patients with active     ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs,     DMARDs and / or TNFα inhibitor therapy.   "
147150|NCT01358162|"     Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the     safety and tolerability and pharmacokinetics.   "
147151|NCT01358149|"     Today, there is an important lack of knowledge on child metabolism and the effects of     phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods. Here,     the investigators will monitor the metabolism of children using minimally invasive techniques     at rest, and with physical/mental activities and assess the changes associated with the     intake of cocoa-based food.   "
147152|NCT01358136|"     The hypothesis of the study is that among patients that do not develop overt hypothyroidism     after hemithyroidectomy, weight gain is a clinical manifestation of a postoperatively lowered     set point of thyroid function - even if the thyroid function is lowered within the laboratory     reference range. The investigators refer to this hypothesized condition as individual     subclinical hypothyroidism.      Thyroid hormones are major regulators of mitochondrial function and subclinical     hypothyroidism affects mitochondrial activity. The aim of the study is to examine if a     lowered set point of thyroid function after hemithyroidectomy can be measured in the     mitochondrial function, the body weight and the basal oxygen consumption.   "
147153|NCT01358123|"     In patients with liver cirrhosis elevated levels of von Willebrand factor antigen (vWF-Ag)     are found frequently but the clinical significance is unclear. vWF-Ag plays an important role     in primary haemostasis and development of thrombotic vascular obliteration is discussed as a     possible mechanism leading to portal hypertension. Invasive measurement of hepatic venous     pressure gradient (HVPG) is the current gold standard for the diagnosis of portal     hypertension. The investigators hypothesize that vWF-Ag levels in plasma may correlate with     portal pressure and predict clinically significant portal hypertension (CSPH, HVPG >=10mmHg)     and its complications.   "
147154|NCT01358110|"     The purpose of this study is to: 1) identify the palliative care needs of Emergency     Department patients with advanced cancer, and determine if these needs can be rapidly     assessed in the ED; 2) determine whether early palliative care consultation improves     survival, quality of life and other burdensome symptoms and decreases utilization as compared     to usual care.   "
147155|NCT01358097|"     The purpose of this study is to investigate the role of the immune system in the response of     squamous cell cancers of the head and neck to treatment that includes radiation therapy.     Current research demonstrates that several natural immune cells and molecules affect the way     the body's immune system interacts with a cancerous growth. Some cancers may be related to     infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of the     immune system in head and neck cancers, especially cancers related to HPV infections, can     provide valuable information to better understand the body's interaction with cancer cells.   "
147156|NCT01358084|"     The main objective of the trial is to document the efficacy of NGR-hTNF administered as     maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma   "
147157|NCT01358071|"     The primary objective of this randomized phase II trial is to compare progression-free     survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients     randomized to an anthracycline alone   "
147158|NCT01358058|"     In this research study the investigators are looking at a type of radiation called proton     radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area     of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects     that patients would normally experience with conventional radiation therapy.      In this research study the investigators are looking to determine if proton radiation with a     reduced field size will be as effective in controlling tumor growth as photon therapy, while     reducing the treatment-related side effects observed in patients with brain tumors.   "
147159|NCT01358045|"     Basal cell carcinoma (BCC) is the most frequent malignant tumor in Caucasians and the     incidence is still increasing with 3-8% each year. Since BCCs generally occur on sun-exposed     areas of the skin, the rice in incidence is mainly explained by the increasing exposure to     (intermittent) ultraviolet radiation. Surgical excision is still the standard treatment for     (micro)nodular BCCs. The costs as well as the increased workload are stressing the health     care system even further and posing BCC an important health care problem. Since half of the     BCCs arise primarily on the face & (bald) head and treatment by surgical excision may result     in disfiguring scars, patients often experience a dramatic decrease of their quality of life.     Hence, there is an urgent medical and societal need for a simple and cheap (targeted)     treatment, preferably to be performed by the patients themselves. This treatment must be safe     and effective. Such treatment is not available yet. BCC tumorigenesis is complex and must be     multifactorial. Genetic alterations of multiple components of the Sonic Hedgehog (SHH)     pathway are involved in sporadic BCC pathogenesis; inactivating mutations in Patched-1     (PTCH1) and activating mutations of Smoothened (SMO) and Suppressor of Fused (SU(FU)). With     this knowledge, inhibition of the SHH pathway by SMO antagonists was successfully     administered, however treatment resulted only in partial clinical response ofBCC. Recently,     involvement of the Wingless (Wnt) pathway has been proven to be essential in BCC tumorigenic     response. Moreover, a recent study of our own department provides the first evidence that     epigenetic alterations, particularly promoter hypermethylation, influence both the SHH and     Wnt pathway (own data, not published), which can serve as therapeutic targets. Both     non-steroidal anti-inflammatory drugs (NSAlDS) and vitamin D derivatives are able to directly     or indirectly target the Wnt pathway. Furthermore, vitamin D3 is able to inhibit Smoothened     (SMO) in vitro, resulting in inhibition of the SHH pathway. Although in vivo studies are     lacking, the investigators assume that topical application of these drugs may inhibit BCC     growth and/or may cure BCC and thus might provide very promising future perspectives.     Calcitriol and NSAlDs ointments are both already available for other indications and save in     use. Eventually, our approach may result in a systematic approach to BCC, targeting     (epi)genetic changes to treat and/or prevent further tumour growth.   "
147160|NCT01358032|"     The main objectives of this study are:        1. an effect evaluation of an in-home multicomponent cognitive behavioural program on          concerns about falling and related avoidance of activity (primary outcomes), as well as          disability, fall incidents (secondary outcomes) and several additional outcomes in frail          community-dwelling older people,        2. a process evaluation of the feasibility of the program, with the following main          outcomes: population reached, performance according to protocol, exposure and          engagement, opinion on the program of participants and facilitators, perceived benefit          or achievement, and experienced barriers and potential solutions, and        3. an economical evaluation on the impact of the program on healthcare utilization and          related costs.   "
147161|NCT01358019|"     The primary objective of this study is to examine a recommended dose for subsequent phase     trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients     with advanced and/or metastatic cancer. The secondary objectives are to study the     pharmacokinetics and antitumor effect.   "
147162|NCT01358006|"     The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible     dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A     binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male     volunteers.   "
147163|NCT01357993|"     The main purpose of this study is to evaluate long-term safety and tolerability of JNS001 at     18 to 72 mg per day in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).   "
147164|NCT01357980|"     The purpose of this study is to determine the efficacy and safety of a single dose of 750 U     of Dysport compared to placebo for the improvement in the daily incontinence episode     frequency for each administration mode in subjects suffering from neurogenic detrusor     overactivity following spinal cord injury or multiple sclerosis.   "
147165|NCT01357967|"     Recently, there are increasing data about intensity dependent amplitude change (IDAP: N100     amplitude slope) of auditory evoked Event Related Potential (ERP) components for its role on     surrogate marker of central serotonergic activity. A high N100 amplitude slope reflects low     serotonergic neurotransmission and vice versa. There are a couple of studies reporting     associations of N1 amplitude slope with response to Citalopram (positive correlation) and     Reboxetine (negative correlation) treatment in major depressive disorder patients (2,3). The     investigator also published a case series about SSRI super-sensitivity and SSRI induced mania     in patients with aberrantly high N100 slope (4). And serotonin transporter gene polymorphism     was studied for its role about pathophysiology of bipolar disorder (5, 6, 7). Serotonin     promoter gene was known to have significant relationship with N100 amplitude slope (8).     Furthermore previous study showed that N100 amplitude slope was well correlated with     hypomanic and hyperthymic personality (9).      Conclusively from above results, the investigator hypothesized that if depressive patients     show aberrant high or low N100 amplitude slope (N100 response outliers), they will not     response well to SSRI medication. They will response better to quetiapine XR adjunctive     therapy. In this study, the investigator will confirm it by comparing treatment effect     between SSRI monotherapy and quetiapine XR adjunctive in aberrant N100 responder.      Hypothesis First visit depressive patients might have monopolar or bipolar depression. If     depressive patients show aberrantly high or low N100 amplitude slope, they will not response     to SSRI medication.      Patients who have aberrantly high or low N100 amplitude slope will response better to     quetiapine XR adjunctive therapy.   "
147166|NCT01357954|"     The project aims to test the effectiveness and explore the possibility of performing a novel     therapeutic approach, targeting to increase strength and coordination around the trunk,     giving a more active and functional seating and head control in those children with cerebral     palsy (CP) who are wheelchair users. The project will also try to determine the muscle     physiological effect of treatment using indirect measures of strength in the spinal     musculature.   "
147167|NCT01357941|"     Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of     recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with     prior VTE are based primarily on expert opinion and the optimal clinical management strategy     remains unclear.      This multicentre, prospective cohort study aims to test the following hypotheses:        1. Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe,          convenient and associated with an acceptably low risk of recurrent VTE in women with a          single prior episode of VTE that was either unprovoked or associated with a minor          transient risk factor. (Moderate risk cohort)        2. Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with          a single prior episode of VTE provoked by a major transient risk factor. (Low risk          cohort)      All study patients will receive 6 weeks of postpartum prophylaxis.   "
147289|NCT01356355|"     The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation     ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent     discomfort.   "
147169|NCT01357915|"     The purpose of this study is to evaluate the persistence of the vaccine induced immune     responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses     of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the     primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in     naturally infected subjects who participated in the screening visit of the primary study     108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value     (seropositive reference group). In addition, this study will continue to assess the     occurrence of CMV infections as well as the continued development and validation of read-outs     in the CMV project.      The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting     (NCT00435396).   "
147170|NCT01357902|"     It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four     eligible, healthy, Chinese male subjects will be enrolled after providing written informed     consent. Subjects will be randomised into two treatment groups 1 day prior to the first     dosing day and will be assigned to regimen sequences (AB or BA) in a balanced fashion in     accordance with the randomisation schedule. Regimen A is five lamotrigine 5 mg     chewable/dispersible tablets and Regimen B is one lamotrigine 25 mg standard/compressed     tablet.      Subjects will receive their allocated regimen on the morning of Day 1 and will undergo study     assessments for 7 days (until Day 8). Subjects will receive their alternate randomised     treatment after a washout period of 14-21 days from Day 1. Subjects will undergo a further     assessment period of 7 days and will attend a follow-up visit during 8-12 days after the     second treatment. The total observation period in this study will be 23~34 days.      Subjects will arrive at the research unit on the evening before each lamotrigine dosing     occasion and will remain in the unit until the 24-h post-dose evaluations have been completed     (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h). After this, subjects will return     home but must return to the unit for further assessments to be made at 36, 48, 72, 96, 120,     144 and 168 h after dosing Study Endpoints/Assessments A total of 19 serial blood samples (5     mL each) will be collected for the measurement of plasma lamotrigine concentrations at each     study assessment. Safety and tolerability assessments (monitoring of adverse events and     serious adverse events, routine laboratory determinations, vital sign measurements and     12-lead electrocardiogram) will be conducted throughout the study.   "
147171|NCT01357889|"     The first part of the study includes a single dose treatment period to evaluate the     pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug     substance compared with process 3 drug substance. The second part of the treatment period     will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and     tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug     substance compared with process 3 drug substance. Subjects with type 2 diabetes whose     glycemia is inadequately controlled on their current regimen of diet and exercise or stable     dose of metformin will be recruited into the study.   "
147172|NCT01357876|"     Metformin is a biguanide that is marketed as an oral anti-diabetic drug. Metformin treatment     in concert with diet and exercise is the consensus first-line treatment for type 2 diabetes     mellitus (T2DM), and therefore it will likely be an adjunct therapy for all assets in     development by GSK for the treatment of T2DM. Metformin has potent effects in lowering     circulating glucose concentrations, and it is believed to have additional benefits in     improving macrovascular outcomes, fatty liver disease and polycystic ovarian syndrome. Its     use in a significant proportion of T2DM subjects is limited by contraindications of heart     failure and renal insufficiency or gastrointestinal side effects. The mechanisms underlying     its glucose-lowering effect and adverse event profile of metformin are not well understood.     Whilst activation of AMP kinase may be important for therapeutic effect, changes in incretin     secretion and bile acid excretion have been described, but not consistently linked to its     therapeutic effect or AE profile. The aim of this study is to recruit T2DM patients on     prescribed metformin monotherapy to further investigate how the glucose effects are related     to the alterations in bile acid absorption, incretin and lipid profiles by studying these     parameters on and off the drug. This will be done in combination with frequent capillary     blood glucose monitoring to ensure patient safety. This study will facilitate the development     of a pharmacodynamic model that can be used by clinical teams developing non-absorbable NCEs     such as iBAT inhibitors.   "
147173|NCT01357863|"     The study will be conducted as a multicenter prospective observational cohort study, trying     to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast     cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing     outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after     1st Trastuzumab progression (second line treatment), and Group 2: patients receiving     Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression     (third line or greater).   "
147174|NCT01357850|"     This exploratory proof of concept study will be conducted in patients with stable New York     Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is     to test the hypothesis that GSK716155 administration will increase glucose uptake and     utilization in the myocardium, resulting in increased myocardial efficiency and increased     exercise capacity. A positive result, defined as either statistically significant effects on     one or more of the efficacy endpoints or as an overall signal suggesting a clinically     relevant effect on myocardial physiology, would provide evidence for potential progression     into further development in a chronic heart failure population.   "
147175|NCT01357837|"     The purpose of the trial is to determine whether GRT6005 is effective in patients with pain     due to osteoarthritis of the knee.   "
147176|NCT01357824|"     The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on     the throat, just below the Adams apple, to occlude the esophagus, in order to prevent     aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this     study will be participate in the discussion of the importance of Sellick´s Maneuver.   "
147186|NCT01357694|"     The major purpose of this study is to determine whether psychotherapeutic contacts for     surgical patients with psychological distress are an effective treatment during the     postoperative period to improve the rate of treatment participation in subsequent     psychosocial treatment programs.   "
147217|NCT01357291|"     A a multi-site trial to measure the efficacy of the Recidivism Reduction Program, a prison     based, twenty-one module reentry program operated by the New Mexico Department of     Corrections.   "
147177|NCT01357811|"     The primary objective of this study is to determine the effect of repeat oral doses of     eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the     pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This     will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects. The     study will comprise a screening period (between Day -45 and Day -2), treatment period 1 (Day     -1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day 24 ±     1). There will be a 10-day washout between dosing of study drug in Period 1 and Period 2. The     duration of each subject's participation in the study, inclusive of the screening and     follow-up visits, will be approximately 10 weeks.   "
147178|NCT01357798|"     The objective of this study is evaluated if the Botulinum Toxin Type A is superior to 0,9%     saline in treatment of cranial Allodynia in patients with headache.      Hypothesis      H(0): Botulinum Toxin Type A is not superior to 0,9% saline in treatment of cranial Allodynia     in patients with headache      H (1): Botulinum Toxin Type A is superior to 0,9% saline in treatment of cranial Allodynia in     patients with headache   "
147179|NCT01357785|"     The purpose of this clinical trial is to both clarify the efficiency of autologous     periodontal ligament (PDL) stem cells to regenerate periodontal tissue in periodontitis     patients with deep intraosseous defects (>5 mm) and to confirm the safety of using autologous     stem cells in clinical periodontal regenerative medicine. This is a single-centre,     randomized, placebo-controlled study. This study has been approved by the ethical committees     of School of Stomatology, Fourth Military Medical University. The study will be conducted     according to the Declaration of Helsinki.   "
147180|NCT01357772|"     The long-lasting phase of precursors of invasive cancer, i.e. dysplasia or intraepithelial     neoplasia (IEN), is particularly relevant among risk determinants. At present, about 15-20%     of all breast cancers are diagnosed in a non-invasive phase. Despite their good prognosis,     women with breast IEN (lobular and ductal intraepithelial neoplasia, LIN and DIN) have a     10-15/1000 annual risk of invasive disease (8-10 times the same age general population), and     thus represent an important target for chemoprevention. In the National Surgical Adjuvant     Breast and Bowel Project (NSABP-P1 trial), tamoxifen use at 20 mg/day was associated with a     86% reduction of invasive breast cancer in women with previous atypical ductal hyperplasia     (ADH) (RR=0.14, 95% IC, 0.03-0.47) and with a 56% risk reduction in women with previous     Lobular Carcinoma in situ (LCIS) (RR=0.44, 95% IC, 0.16-1.06). However, tamoxifen use in this     setting is hampered by serious adverse events attributable to its partial estrogenic     activity, such as increased risk of endometrial cancer and of venous thromboembolism, which     have significantly limited its broad use in chemoprevention.      To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed.     Recent trials from our group have shown that the dose can be reduced up to 1 mg/day with no     loss of tamoxifen antiproliferative activity on breast cancer. By contrast, a dose of 5     mg/day does not increase endometrial proliferation and is associated with a decrease of the     estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding     globulin (SHBG) and antithrombin-III, with a potential decrease of venous thromboembolic     events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day     attains at the breast tissue level a concentration 10 times higher than that needed to     inhibit cell growth in vitro. The promising clinical activity of 5 mg/day of tamoxifen is     supported by an ongoing 2x2 phase IIb trial of low-dose tamoxifen and fenretinide in     premenopausal women, where tamoxifen lowers breast cancer events compared with placebo. The     cytochromeP450 2D6 (CYP2D6) enzyme mediates oxidation of N-desmethyl tamoxifen to endoxifen,     the most active metabolite of tamoxifen. The single nucleotide polymorphism (SNP) CYP2D6*4     (1846G>A) allele accounts for 75% of CYP2D6 poor metabolizer phenotype and poor metabolizers     showed a trend to a higher risk to develop a breast event compared to wildtype.   "
147181|NCT01357759|"     This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in     healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine     the safety and tolerability of MORAb-022.   "
147182|NCT01357746|"     This is a non-invasive study using a standard doppler echocardiographic transducer which     records signals emanating from the lungs (TPD). These signals are caused by pulsation of     blood vessels in the lung tissue.      The innovations in this study are:        1. The software processing of the reflected ultra-sound waves from the lung rendering a          reproducible, clear and strong signal in sync with the cardiac cycle,        2. The observation based on pilot studies that blowing hard against resistance during          recording (something called a Valsalva maneuver), affects the lung signal weakening it          and even obliterating it as the pressure rises.      The investigators hypothesis is that since the signal comes from the blood vessels in the     lung, the pressure at which the recorded signal disappears during the Valsalva maneuver     represents the blood pressure in the lungs.   "
147183|NCT01357733|"     Newly diagnosed diffuse large B cell lymphoma (DLBCL) patients who enter this study will     receive baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) computed     tomography (CT) scan at the time of initial staging. The patients will be diagnosed and     undergo initial staging according to The Catholic University Lymphoma Group (CULG) Protocol.      After 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone     (R-CHOP) chemotherapy, early interim FDG PET/CT will be obtained after the patient recovers     from nadir (usually 13 to 16 days after) following the administration of first cycle of     R-CHOP,immediately before the second cycle of R-CHOP. The result of early interim FDG PET/CT     study will not impact patient management, except in rare case where newly developed lesion is     found and biopsy confirmed.      The same PET/CT system and analysis software will be used for all scans from baseline to     surveillance for all patients enrolled in this study.      After 3 cycles of R-CHOP, a mid-therapy interim FDG PET/CT will be obtained. Patients with     newly developed lesion will receive different chemotherapy regimen, while patients with     stable disease, partial metabolic response or complete metabolic response will continue to     receive 3 more cycles of R-CHOP.      After the completion of 6 cycles of R-CHOP, the patients will receive a FDG PET/CT scan for     response assessment. Selected patients with persistent disease or very bulky tumor volume on     initial staging images will receive additional radiation therapy.      The patients will be followed up every 3 months for 2 years from beginning of therapy.     Physical examination and lab studies will be done usually every 3 months. Imaging studies     will be performed every 3 months alternating between enhanced CT and FDG PET/CT and noted     when different schedule is applied for surveillance.      The end points are changes in FDG uptake measurements between the baseline and early interim     FDG PET/CT, and between baseline and mid-therapy interim FDG PET/CT scans; response     assessment following completion of 6 cycles of R-CHOP with or without radiation therapy     assessed by International Workshop Criteria (IWC)+PET and PET Response Criteria in Solid     Tumors (PERCIST) guideline; and the 2 year disease free survival.   "
147184|NCT01357720|"     This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by     Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for     all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface     antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and     anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.   "
147185|NCT01357707|"     The project strives to discover novel genetic defects that cause monogenic epilepsy or that     genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes     for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral     malformation, lissencephaly or metabolic disorders and which have a comparatively benign     prognosis.      The investigators hypothesize that mutations in genes coding for ion channels or genes that     modify the action of ion channels might be causative.      For that the investigators will perform a sequence analysis of the coding exons of a large     set of genes in all recruited patients and verify found mutations in their parents.   "
147187|NCT01357681|"     Huntington's disease (HD) is an inherited autosomal dominant, progressive neurodegenerative     disease. Clinically, HD is characterized by a triad of movement disorders, cognitive     impairments and psychiatric disturbances. These symptoms represent a tremendous burden for     patients and caregivers. HD is a fatal disorder with neither cure, nor evidence-based     standard therapy available.      The green tea polyphenon (2)-epigallocatechin-3-gallate (EGCG) was shown to have beneficial     effects in cell and animal models of HD. The aim of this study is to evaluate the efficacy     and tolerability of EGCG in HD.      The investigators hypothesize that Sunphenon EGCG administered at a maximal daily dose of     1200 mg compared to placebo during a period of 12 months improves cognition in patients with     HD. As primary outcome measure, the change of cognitive functions (as measured by the Unified     Huntington's Disease Rating Scale (UHDRS)-Cognition composite score of Stroop test, Verbal     fluency & Symbol Digit Modalities Test) after 12 months in comparison to Baseline was     defined.      The investigators further expect a positive influence of EGCG on other clinical     manifestations of HD, measurable effects of EGCG on HD biomarkers and good safety and     tolerability of EGCG in HD patients.   "
147188|NCT01357668|"     The purpose of this study is to examine the long-term safety of Abatacept for the treatment     of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of     serious infections, autoimmune disorders, and malignancies.   "
147189|NCT01357655|"     The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP)     CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.   "
147190|NCT01357642|"     This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation     Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in     comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist     (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.   "
147191|NCT01357629|"     This study examines the long term Safety Follow-up of first patients vaccinated with AD02.   "
147192|NCT01357616|"     The purpose of this study was to compare the intraocular pressure (IOP)-lowering efficacy and     safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily     versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution,     each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular hypertension     who were insufficiently responsive to monotherapy.   "
147193|NCT01357603|"     The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to     its total and to its maximum serum insulin concentrations.   "
147194|NCT01357590|"     ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending     thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a     0.035 guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit     technique may be required to allow access to the arterial system. The soft tapered tip allows     atraumatic insertion into the vessel, while the catheter and sheath are designed to provide     excellent flexibility and control through tortuous arterial anatomy.      Each individual stent graft device is supplied sterile and pre-loaded in a single-use     delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin     wall woven polyester and nitinol ring stents, which are attached to the fabric with braided     polyester sutures. The delivery system central catheter is a stainless steel braided     co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide     significant torque control and strength, while also maintaining superior flexibility. The     outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless     steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant     coating. These materials provide very low friction force during device insertion and     deployment together with enhanced flexibility of the delivery system. The handle components     are moulded from thermoplastic polyurethane.      The materials of the endoprosthesis are identical to those of the current Conformité     Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal     aortic aneurysm repair. The materials of the delivery system are well established in medical     applications. The design of ThoraflexTM is based on the same principles as other clinically     established thoracic endovascular devices. The endoprosthesis is constructed of     self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the     endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery     system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal     deployment position can be enhanced.      The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the     descending thoracic aorta, which is identical to other CE approved thoracic endovascular     devices.   "
147195|NCT01357577|"     With this research, the investigators hope to learn if cognitive behavioral therapy (CBT) for     posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with     drugs or alcohol. In the past, people who had problems with drugs and alcohol were not given     treatment for their PTSD. It was believed that PTSD treatment would get in the way of their     drug and alcohol treatment. Now the investigators believe that the PTSD symptoms may make it     harder to avoid using drugs and alcohol, so the investigators want to see if people can get     treatment for both problems at the same time.      One hundred-sixty Veterans from 3 VA sites will be in this study. All Veterans will be     getting outpatient substance abuse treatment. In order to know if the PTSD treatment is     helpful, half of the Veterans in this study will receive PTSD treatment and half will     continue to get their usual substance abuse treatment. Who gets which treatment will be     decided by a random process. The investigators will then compare the 2 groups to see if there     are differences in their PTSD symptoms.   "
147196|NCT01357564|"     This proposed study addresses this call by testing the efficacy of a transformative     patient-centric intervention designed to reduce the burden of NPS in Veterans with dementia     who live at home with family caregivers. The innovative intervention, the Tailored Activity     Program (TAP-VA), involves 8 sessions over 4 months in Veterans' homes. An occupational     therapist conducts a systematic assessment to identify a Veteran's preserved capabilities and     deficit areas, and previous roles, habits and interests from which to develop and introduce     activities tailored to the Veteran's profile. Family caregivers are then trained to     incorporate tailored activities into daily care routines. The intervention was pilot tested     in an NIMH funded study with 60 community-living individuals with dementia. Findings from     this pilot showed statistically significant and clinically meaningful reductions in NPS,     specifically agitation and less time being on duty by family caregivers. Results of this     pilot phase support moving forward with a full-scale Phase III efficacy trial. The     investigators plan to test TAP-VA in a randomized two-group parallel design in which 160     racially and ethnically diverse Veterans with dementia and their family caregivers (dyads)     will be randomly assigned to receive TAP-VA or an attention control group. All dyads will be     evaluated at baseline and 4-months (main trial endpoint), and then reassessed at 8-months to     evaluate long-term treatment effects (baseline to 8 months), including continued activity     use, caregiver well-being, and costs.   "
147322|NCT01355926|"     The purpose of this study is to help us to better understand the effects of two different     types of surgical techniques on pain and quality of life in patients with precancerous     lesions or early stage mouth cancers.   "
147200|NCT01357512|"     The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging     (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer     based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized     to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided     biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI     evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.   "
147201|NCT01357499|"     The purpose of this study is to investigate if remote ischemic preconditioning by combining     limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better     results in preconditioning the human heart than limb ischaemia alone does.   "
147202|NCT01357486|"     The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in     France and about 2 / 3 of patients, are not eligible for curative treatment at the time of     diagnosis. The palliative management of patients with advanced and symptomatic disease is     complex and requires treatment combining anti-tumor activity and safety in patients with     impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the     benefit of sorafenib in patient with altered liver function is uncertain. The aim of this     trial is to study the interest of sorafenib in patients with HCC and impaired liver function     compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination     sorafenib/pravastatin or to best supportive care (usually used in these patients).   "
147203|NCT01357473|"     The proposal of this study is to evaluate the association between the achievement of ongoing     pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH-     antagonist cycles.   "
147204|NCT01357460|"     Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might     benefit from endoscopic implantation of intrabronchial valves.   "
147205|NCT01357447|"     Patients with Sjogren's disease have destruction of the mucus secreting cells in the airway.     This manifestation of the disease leads to the common complaint of persistent dry cough that     is seen in many of these patients. This study is aimed at determining whether the regular use     of Pulmozyme will result in decreased cough and improved quality of life.   "
147206|NCT01357434|"     Rating systems are intended to guide consumer choices. This project will determine if a     previously developed scale that evaluates the healthiness of a restaurant is correlated     with the actual choices consumers make when they patronize the restaurants. The study will     also assess whether a restaurant marketed as healthy (Subway) rates higher on this scale     than another restaurant that makes no such claims (McDonald's). Finally, the investigators     will compare the calorie purchases from these two restaurants among youths and their families     who eat at each of the restaurants.   "
147207|NCT01357421|"     This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers     participating in an endotoxin challenge.   "
147208|NCT01357408|"     The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL     Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass)     data to predict future cardiac events in heart failure (HF) patients recently discharged     after a hospitalization for heart failure who have or plan to have a implanted loop recorder     (ILR), specifically, the Reveal XT device. The study will enroll 40 HF patients (with LV     function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for     heart failure who either have a Reveal XT device in place or plan to have the ILR device     inserted for clinical indication within 14 days of discharge from the hospitalization. HF     patients will be followed for 6 months. Device date will be captured during normal clinic     visits and at 6 months.   "
147209|NCT01357395|"     The purpose of the study is to evaluate the safety and potential benefit of combination     amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small     cell lung cancer (SCLC) subjects.   "
147210|NCT01357382|"     Current obesity prevention emphasizes caloric restriction and avoidance of high fat foods.     The result is an approach that replaces dietary fat with carbohydrates. There has, however,     since been an obesity epidemic with an increased prevalence of metabolic syndrome (MetS) and     type II diabetes. Negative results from trials of low fat diets for weight loss, prevention     of heart disease and malignancies are consistent with the inadequacy of low fat/high     carbohydrate approach. One of the findings of trials comparing low fat, calorie reduced diets     to ad lib carbohydrate restricted diets is that subjects randomized to a low carbohydrate     intake lose more weight despite equivalent intake. This equates to a 200 kcal/day greater     weight loss on a carbohydrate restricted diet. Some investigators have speculated the     metabolic advantage of carbohydrate restriction is due to increased energetic costs of     gluconeogenesis. Alternatively, carbohydrate restriction is associated with increases in     spontaneous physical activity.      This protocol has three aims. First, adherence to a carbohydrate restricted diet in subjects     with metabolic syndrome will cause an increase in spontaneous physical activity, independent     of weight changes. Second, cardiometabolic risk factors (ApoB, TG, HDL, blood pressure, CRP)     will show greater improvement on a carbohydrate restricted diet compared to a low-fat, high     carbohydrate diet. Finally the investigators will interview a sub-sample of participants to     better understand quality of life issues with respect to the dietary assignment or lifestyle     intervention.      The investigators will recruit 72 participants with MetS, from the Metabolic Syndrome Program     at St. Paul's Hospital, Vancouver. Individuals will be randomized to either a     low-carbohydrate diet or a calorie restricted, low fat diet and followed for 6 months. The     investigators will measure body composition with bioelectrical impedance at baseline, 3 and 6     months. The investigators will also examine cardiometabolic changes due to the standard     lifestyle intervention compared to the carbohydrate restricted treatment. The investigators     will examine blood pressure, triglycerides, LDL-chol, HDL-chol, C-reactive protein,     apolipoprotein B, glucose, insulin, hemoglobin A1c and leptin at baseline, 3 and 6 months.     The investigators will use accelerometers to assess changes in physical activity. The     investigators will use three-way repeated-measures ANOVA, with changes in body weight and     insulin levels as covariates in the model with time as the repeated factor for statistical     analyses.   "
147214|NCT01357330|"     Primary Objective:      - To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D)     of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or     metastatic solid tumors.      Secondary Objective:        -  To characterize the safety and tolerability of SAR245408 and MSC1936369B combination          therapy administered orally to adult patients with locally advanced or metastatic solid          tumors        -  To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in          combination        -  To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by          assessing target and pathway inhibition   "
147215|NCT01357317|"     Objective: To examine the effects of three commonly applied treatments of disordered     phosphorus homeostasis on biochemical markers and vascular characteristics in patients with     moderate and advanced non-dialysis dependent chronic kidney disease.   "
147216|NCT01357304|"     The purpose of this study is to determine the effects of group treatment including physical     activity referral (PAR) on level of physical activity and quality of life in patients     diagnosed with type 2 diabetes and/or hypertension in a primary health care setting   "
147218|NCT01357278|"     The main objective of this study is to target risk factors for falling, such as improved     quadriceps muscle strength,balance and bone mineral density (BMD), to reduce the risk of     osteoporotic fractures. Furthermore, to improve quality of life for patients with     osteoporosis through an active rehabilitation program.      Sub-goals:        1. To assess the effect of active rehabilitation on risk factors for osteoporotic fractures          (muscle strength, bone mineral density, balance and frequency of falling) in women with          low bone mineral density (BMD)(t-score<1.5) and radius fracture?        2. To assess how active rehabilitation affect the quality of life of women with low bone          mineral density(BMD) (t-score<1.5) and radius fracture?   "
147219|NCT01357265|"     This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when     administered to adult and elderly subjects.   "
147220|NCT01357252|"     The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd     as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled     with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting     the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in     the treatment of type 2 diabetes.   "
147221|NCT01357239|"     This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective     in treating the behavioral symptoms of Fragile X Syndrome.   "
147222|NCT01357226|"     Context: Use of automated blood pressure (BP) measurement devices in the office setting is     increasingly recognized as superior to manual BP measurement. Current recommendations are to     have the patient alone in a quiet room, with no interactions with health care professionals     during the readings. However, this may not be practical in primary care offices where the     exam rooms are constantly being used.      Objective: To compare measurements with an automated BP device in private examination rooms     with measurements in non-private areas of a primary care office.      Design: Randomized controlled trial with cross-over.      Setting: Community based primary care office participating in the NorTReN Practice Based     Research Network in Toronto, Ontario.      Participants: Fifty consecutive consenting patients over the age of 18 having their BP     checked as part of their routine care.      Intervention: Patients will be randomly allocated to either automated BP measurement in an     exam room, or in a non-private area of the clinic. After being tested in the first location     they will subsequently be tested in the second location with the same device.      Main outcome measure: The primary outcome measure is a comparison between the mean systolic     values of the automated BP measurements in the two office areas. The investigators will use     the t-test for paired samples. The secondary outcome is a comparison of systolic values for     patients with previously documented hypertension. The investigators define a clinically     meaningful result as a difference of 5 mmHg or more in systolic BP.      Conclusion: New technology is more readily adopted if barriers to use are minimized. If the     investigators find no differences in BP readings between office locations, physicians will     then have the convenience of an additional office area to implement the automated BP     measurement device.   "
147223|NCT01357213|"     This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study     of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be     hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the     24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum     monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in     which they will receive a single intravenous infusion of active drug or placebo. Placebo will     be normal saline. Volunteers will be followed for safety for up to 120 days after infusion     depending on dose cohort.   "
147224|NCT01357200|"     This study will assess enteral feeding in an obese critically ill population with a higher     protein whey based peptide formula.   "
147225|NCT01357187|"     The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the     reduction of the tenacity and frequency of soft tissue adhesions during the removal of     segmental posterior lumbar instrumentation.   "
147226|NCT01357174|"     This study will collect demographic and safety information on the use of ROTATEQ™ in the     Philippines.   "
147227|NCT01357161|"     This is a study of the safety and efficacy of MK-1775 in combination with paclitaxel +     carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with     the P53 mutation. In Part 1, a small group of participants will receive MK-1775 along with     paclitaxel and carboplatin to find the maximum tolerable MK-1775 dose for this combination.     Pharmacokinetics will also be assessed during this period. In Part 2, participants will be     randomly assigned to receive either MK-1775 + paclitaxel + carboplatin or placebo +     paclitaxel + carboplatin.   "
147228|NCT01357148|"     The primary objective of this study is to obtain safety information on the use of sitagliptin     phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists,     internists, and general practitioners.   "
147229|NCT01357135|"     This is an observational study to compare the effectiveness of dual therapy of Type II     diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine     clinical practice in France.   "
147230|NCT01357122|"     This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer     Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current     standard forceps insertion DSAEK technique. The goal of this study is to examine the damage     to the corneal endothelium resulting from the use of the NCI device in comparison to the use     of our standard surgical DSAEK technique over time.   "
147233|NCT01357083|"     One of the main points in the biological trends is, the circadian rhythm and disturbance in     this cycle, which cause mood disorders and irregularity in this bio clock, to get depression.     The pineal gland with the precise regulation of circadian rhythm of melatonin regulates the     brain haemostasis. The abnormal function of this gland gives rise to psychiatric disorders.      In the period of youth and early of middle-age cause biochemical changes and disturbance in     biorhythm including melatonin secretion.      This process can change the peak of melatonin phase. In addition, a decrease in the level of     serum melatonin, can change the function of immune system of depressed patients. This     function facilitates the process of cancerous cell formation and tumor growth.      With respect to the conflicting results and that the positive and negative roles of melatonin     in the creation of depression is unknown, the aim of this study was to compare the morning     and nocturnal serum melatonin rhythm levels in the patients with Major Depressive Disorder.     The second purpose was to measure the morning and nocturnal serum melatonin levels in the     depressed and healthy men and women.   "
147244|NCT01356940|"     A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect     on ambulatory activity in people with multiple sclerosis   "
148778|NCT01336725|"     The purpose of this study is to determine whether the participants have improved their scores     on health related quality of life (HRQL) 1 year after completing a learning and mastery     course and whether sociodemographic variables are associated with HRQL.   "
147234|NCT01357070|"     Atherosclerosis is the disease process that leads to hardening of the arteries which causes     them to become narrowed. This occurs because fat is first deposited on the inside walls of     the arteries, then becomes hardened by fibrous tissue and calcium deposition forming a     semi-hardened accumulation of material known as plaque. As this plaque grows, it narrows the     channel within the artery and causes a reduction in blood and oxygen supply to the affected     organ - such as the heart and brain. The investigators now understand that this process is     caused by inflammation and activation of the immune cells over a period of time. It has been     proposed that targeting these immune cells and reducing the levels of immune activation can     protect against cardiovascular diseases.      Previously it has been observed that consumption of fruit and vegetables rich in     anti-oxidants can confer a protective effect against cardiovascular diseases. The use of     anti-oxidants experimentally has shown protective benefits against activation. The     investigators suggest that inducing anti-oxidant enzymes indirectly may be an effective means     of providing vascular protection.      Sulforaphane, a naturally occurring compound found in green vegetables (including broccoli,     brussel sprouts and cauliflower) is able to protect against cell inflammatory stress by     inducing a number of anti-oxidant molecules. Targeted studies on the consumption of broccoli     and related vegetables have been shown to be associated with reduced risk of coronary artery     disease.      In the present study the investigators want to test whether the consumption of a broccoli     smoothie containing sulforaphane can protect white blood cells from becoming activated in     the presence of an experimental stress and how long this protective effect lasts for. To do     this, the investigators will be analysing inflammatory changes in blood samples taken at     different times during the study.   "
147235|NCT01357057|"     The goal of this observational study is to develop and validate a predictive score of 1-year     outcomes in subarachnoid hemorrhage (SAH) patients receiving aneurism coiling.      Using our database filled up prospectively, the investigators plan to collect clinical,     biological and radiological admission characteristics of coiled SAH cases and their 1-year     Rankin outcome score during 5 years (2003-2007). The investigators plan to confirm our score     in a validation cohort (from 2008 to 2009).   "
147236|NCT01357044|"     this is a prospective randomized placebo-controlled double-blinded trial investigating the     effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The     investigators hypothesize that these plant extracts will improve semen quality.   "
147237|NCT01357031|"     The purpose of this study is to determine the effectiveness of melatonin 3 mg compared to     placebo and amitriptyline 25 mg in the preventive treatment of migraine.   "
147238|NCT01357018|"     Chronic joint complaints are prevalent in clinical practice. If chronic arthritis such as     rheumatoid arthritis (RA) or ankylosing spondylitis (AS) is not adequately controlled, it can     not only affect patient's working ability but also produce indirect cost in patient's family.     Quality of life will also be affected. Health-related quality of life issues are assuming     increasing importance in chronic rheumatic diseases. However, studies on quality of life in     rheumatic patients are limited. Factors related to quality of life are not clear. Application     of quality of life measurement for improving clinical care of RA and AS patients is still     difficult. The objective of this study was to evaluation the validity of EQ-5D life quality     measurement in chronic arthritis patients in Taiwan. Factors associated with life quality     will be addressed. This will also provide useful information for public health policy making.   "
147239|NCT01357005|"     This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications     that propose to enrich pre-existing resources for schizophrenia in the NIMH Human Genetics     Initiative and to apply genomic methods to further our understanding of the molecular     etiology of the disorder. The overarching aims of this proposal are to quickly and     cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to     discover causal variants for the disorder in the first family-based genome-wide association     study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind     of GWAS study as it is a very expensive study, including collecting large family samples and     genome-wide SNP scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang     and his intended subcontracted researchers to apply for this project. The investigators, the     research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia.      The investigators will meet the overarching goals of this project by accomplishing several     Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese     clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending     all clinical data and biomaterials to the appropriate repositories; 3) Assess the association     of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their     constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset     ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6)     Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions,     such as the well-established effect of season of birth.   "
147240|NCT01356992|"     This non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®,     Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main justification     is the search for scientific evidence to prove the Versa® effectiveness for this new     therapeutic indication, since it is a product with potential for reducing costs, with     effectiveness and safety comparable to the reference drug.   "
147241|NCT01356979|"     Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in     the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant     pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous     pleuritis make confusion in clinicians. Whether these patients are firmly followed or not ?     The investigators do not know the answer of this question.      In this study the investigators aimed to investigate the outcome of the patients who are     diagnosed as fibrinous pleuritis on MT biopsies.   "
147242|NCT01356966|"     Patients with chronic kidney disease have profound exercise intolerance which contributes to     an increased risk of cardiovascular disease. The investigators have found that chronic kidney     disease patients have an exaggerated increase in blood pressure during certain forms of     exercise that could certainly contribute to exercise dysfunction as well as cardiovascular     risk. The investigators will test the mechanisms underlying this exaggerated blood pressure     response, as well as the potential benefits of short-term tetrahydrobiopterin (BH4) with     folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney     disease. The investigators will test whether short-term treatment with tetrahydrobiopterin     (BH4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular     health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.   "
147243|NCT01356953|"     The purpose of this study is to determine if a single session of aerobic exercise effectively     controls the blood pressure (BP) of individuals with type 2 diabetes mellitus (T2DM) over the     24h of post-exercise period, and the effects of intensity of aerobic exercise on these BP     responses.   "
147245|NCT01356927|"     Contraception after abortion is an important public health issue, as women who have an     abortion are at high risk for additional unintended pregnancy. In the context of first     trimester medical abortion, the standard of care is to administer long-acting reversible     contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone     acetate (DMPA), at a follow-up appointment after the abortion.      The investigators plan to conduct a prospective observational pilot study to evaluate the     satisfaction of subjects who have selected either the contraceptive implant or DMPA given on     the first day of medical abortion, as opposed to at a follow-up appointment. The     investigators will also assess the continuation of DMPA and Implanon at 3, 6, 9, and 12     months after the initial date of administration. In addition, the investigators will assess     the total days of bleeding after the abortion, follow-up rate for evaluation of completion of     medical abortion, and efficacy of medical abortion.      A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA.     They will be asked to fill out questionnaires during the course of the study, and will be     followed for one year. The study duration including data analysis will be two years.   "
147246|NCT01356914|"     The purpose of the study is to determine whether treatment with BMS-914392 is safe, well     tolerated and associated with a reduction of atrial fibrillation burden in patients with     paroxysmal atrial fibrillation and permanent pacemaker.   "
147247|NCT01356901|"     The purpose of this observational study is to measure the real-life persistence, adherence     and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.   "
147248|NCT01356888|"     The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with     the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss     in a non-inferiority study in de novo coronary lesions at 9 months.   "
147249|NCT01356875|"     Transfusional dependence has been associated closely and independently with low survival in     patients with myelodysplastic syndrome (MDS), especially in patients at low risk according to     IPSS. Treatment of patients with hydralazine + valproic acid as an alternative to treatment     with 5-azacytidine has lower cost and possibly as effective with fewer side effects. The     objective of this phase II study is to determine the effectiveness of combination therapy     with hydralazine + Ac. Valproic compared with best supportive care. The investigators will     select 42 patients per group, and after 14 weeks of treatment the investigators will study in     both groups the hematological response (transfusion-dependent, hemoglobin, cytogenetics and     morphology) and treatment safety (adverse reactions and vital signs) to 1 year after starting     treatment. The concentration of hemoglobin, the number of transfusions, platelets,     neutrophils and other continuous variables in both groups will be compared by Student t or     Mann-Whitney, as appropriate. For comparison of cytogenetic and morphological response and     other categorical variables between groups Chi square will be used. And within each group the     investigators will compare each of these variables before and after treatment by t-test for     paired data or Wilcoxon test.   "
147250|NCT01356862|"     The principal morbidity following axillary node dissection within the scope of breast cancer     surgery is the post-operative development of lymphocele. According to the literature,     incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is     inserted or a compression dressing applied and the time at which the drain is removed… In our     experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70 patients     between November 2008 and February 2009]      Encouraging results in terms of reducing postoperative lymphoceles as well as drainage     duration and volume using Octreotide have been recorded in two recent studies. A new molecule     developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog possessing     strong affinity for several somatostatin receptors (30 to 40 times greater for sst1 and sst5,     5 times greater for sst3 and equivalent for sst2)      The purpose of this trial is to assess the efficacy of a pre-surgical injection of     pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following     axillary node dissection.      The secondary objectives are to assess the efficacy of prolonged release pasireotide on the     duration of postoperative drainage, the daily drainage volume, the total drainage volume, the     number of repeated lymphocele aspirations and the volume, the total volume of lymph     aspirated, the incidence of postoperative febrile episodes, the length of hospital stay, and     the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of     prolonged release pasireotide.      The primary objective of this study is to assess the efficacy of a preoperative prolonged     release pasireotide injection in the reduction in the incidence of symptomatic, postoperative     axillary lymphoceles following mastectomy-axillary node dissection.   "
147260|NCT01356732|"     Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU)     however their treatment remains unclear. This prospective pharmacodynamic study relates to     the analgesia of procedural pains. The primary objective was to determine the 90% effective     dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral     Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated     patients.      Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation,     reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were     included.      During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of     sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new     LD until BPS was at 3 or 4.   "
147359|NCT01355432|"     This is a prospective pilot study to quantify the changes in heart rate when propofol is     administered after inhalational anesthesia induction.   "
147939|NCT01347840|"     The objective of this study is to determine whether the metabolic, endocrine and energetic     response to short term caloric restriction are factors in weight loss in subjects having     gastric bypass (GB) surgery.   "
147261|NCT01356719|"     Tracheostomies are artificial airway devices inserted into the neck. They can become     displaced and lead to patient harm. Other than external visual inspection, there is no     currently described system for describing the position of a tracheostomy tube within the     airway. The investigators propose to undertake endoscopic inspection of the tracheostomy tube     with a small fibre-optic camera from above and also through the tube to visualise its     position within the airway. The investigators will take anonymised paired images and then     score these using 6 different scoring systems. The investigators will determine which scoring     system provides the simplest and most reproducible scores between 6 blinded assessors. A     clinically useful scoring system could be used in future to predict problems with     tracheostomy positioning.   "
147262|NCT01356706|"     Only few reports exist on long-term survival after minimally invasive liver surgery (MILS for     colorectal liver metastases. No data are available assessing prognostic factors in the era of     current modern treatment strategies. The aim of the current study is to analyze the long-term     oncologic outcome after MILS for metastases from colorectal cancer and determine prognostic     indicators.   "
147251|NCT01356849|"     Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of     the study is to evaluate the efficacy and safety of once daily administration of atrasentan     tablets (low dose and high dose) compared to placebo in reducing residual albuminuria in Type     2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose     of a Renin Angiotensin System (RAS) inhibitor. If the patient is already receiving a maximum     tolerated labeled daily dose of RAS inhibitor and a diuretic, he/she will complete 4 weeks of     the Run-in Period on a dose that has not been adjusted. If the patient is currently not     receiving a maximum labeled daily dose of a RAS inhibitor then the dose will be titrated up     to the maximum tolerated labeled dose over the course of 4 to 8 weeks during the Run-in     Period. It is expected that subjects not receiving a diuretic will have a diuretic added or     titrated during this period to maximize RAS inhibition. Following titration to the maximum     tolerated labeled dose, the patient will complete an additional 4 weeks of Run-In Period on     an unchanged doses of RAS inhibitor and diuretics, unless medically contraindicated. The     randomization will be stratified based on country where subjects are enrolled into the study,     and the Week -1 Urinary Albumin to Creatinine Ratio (UACR) levels (< or = 1000 mg/g [113     mg/mmol], or > 1000 mg/g [113 mg/mmol]). Within each stratum, subjects will be randomly     assigned in a 1:2:2 ratio to one of the following blinded treatment groups: Group A - Placebo     once daily (QD) Group B - low dose atrasentan QD Group C - high dose atrasentan QD After the     12 weeks of study drug treatment, subjects will be followed up to 30 days.   "
147252|NCT01356836|"     Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia.     Collateralization helps to restore blood flow and as a result salvages myocardium in severely     ischemic myocardial regions. Thus, good collateral development in patients with severe     coronary artery disease (CAD) improves ventricular function and prognosis (1-3).      However, coronary collateral development is different among patients even with similar     degrees of coronary artery stenosis. Several factors, such as diabetes mellitus (4) and     duration of myocardial ischemic symptoms (5) have been reported to effect coronary collateral     development. At the cellular level, inflammatory cells, especially monocytes have an     important role in collateralization. In a series of experimental studies with animals, it has     been shown that monocytes are important elements for development of collateral vessels (6-7).     In a recent study, it has been demonstrated that increased circulating monocyte count is     related to good collateral development in patients with stable coronary artery disease (8).      Monocytes in human blood are heterogeneous and can be classified into two subsets according     to the presence or absence of the FcγRIII receptor CD16 (9): CD14++CD16- monocytes     characterized by high level expression of the CD14 cell surface receptor but no expression of     CD16 receptor, and CD14+CD16+ monocytes characterized by the co-expression of CD16 receptor     with either high or low level expression of the CD14 receptor. These subsets differ in     function and response to several cytokines.      Our aim in this study was to find out any possible relationship between the levels of     circulating monocyte subsets and coronary collateral development.   "
147253|NCT01356823|"     This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine     expressed in E. coli.      The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce     higher antibody and at the same time caused less adverse events.      The secondary purpose of this study is to to evaluate the safety and immunopersistence of the     study vaccine.   "
147254|NCT01356810|"     Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course     which is presented in 15 to 20% of patients admitted to general wards. It is a potentially     life - threatening complication which can be prevented. It is the objective of this     randomized controlled trial to evaluate whether a multicomponent environmental intervention     could reduce the incidence of delirium in a general medical ward.   "
147255|NCT01356797|"     Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia     technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been     validated for this surgery. Both selective techniques are specially indicated for ambulatory     surgery because of PACU fast track, low discharge home time and high patient satisfaction.     This study compares both spinal techniques for knee arthroscopy surgery.   "
147256|NCT01356784|"     TEst the effect of Tailored Physical Activity or Chronic Pain Self-management Program on     Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body   "
147257|NCT01356771|"     The investigators are conducting a study to provide evidence about the comparative     effectiveness of mailed, tailored intervention materials on cancer prevention behavioral     outcomes. The investigators will send out three (3) tailored mailings for participants who     are assigned to the intervention group. Second, during the eligibility screening, the     investigators will be assessing the relative yield and functioning of two risk assessment     tools (BRAT and FEARS) on determining an individual's level of risk for skin cancer.   "
147258|NCT01356758|"     Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3%     in the caucasian population of Northern Europe and the US. Similarly to other inflammatory     diseases there is now substantial and accumulating evidence that psoriasis has a systemic     inflammatory component.      It is known that patients suffering from psoriasis have increased prevalence of traditional     cardiovascular risk factors, such as hypertension, dyslipidaemia, obesity, tobacco use and     diabetes mellitus. This would logically explain an increased rate of cardiovascular events,     but even when adjusting for theses risk factors, psoriasis carry an independent risk for     developing cardiovascular disease.      Recent large epidemiological studies have shown a strong correlation between psoriasis and     myocardial infarction.      Atopic dermatitis has been linked to ischemic stroke in one study, but besides this, the     disease has not been associated with cardiovascular disease.      In conclusion, convincing and increasing evidence is supporting that psoriasis induce     accelerated atherosclerosis and hence cardiovascular disease and mortality. In particular,     this is seen in young patients with early disease onset.      Psoriasis is believed to be driven by cytokines produced by Th1 and Th17 lymphocytes. A     number of these cytokines are suggested to be atherogenic. In contrast, another chronic     inflammatory disease, atopic dermatitis, is predominantly driven by Th2 lymphocyte derived     cytokines, some of which may inhibit atherosclerotic processes. It is therefore, of interest     to compare the presence of cardiovascular disease in these two inflammatory skin diseases.      Hypothesis: That the risk of developing cardiovascular disease and especially coronary artery     disease is increased in psoriasis patients and that this process can be influenced by     treatment of psoriasis with biological treatment.   "
147259|NCT01356745|"     Less than 10% of patients with a traumatic pain have been managed by a physician before to be     admitted in an emergency service. 50 % of those patients have been carried by paramedics.     Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies have     demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of premixed     nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.   "
147263|NCT01356693|"     Cough is the most bothersome symptom for patients with the common cold.      The objective of the study is to compare the phytotherapic Bromelin, a compound preparation     of honey from the bee apis mellifera with the extract of the pineapple (Ananas comosus) with     placebo in reducing cough episodes in patients with the common cold.   "
147264|NCT01356680|"     This study is designed to test the non-inferiority of the experimental arm compared to the     standard arm in terms of progression free survival (PFS).   "
147265|NCT01356667|"     Drum-Assisted Recovery Therapy for Native Americans (DARTNA) is an R-21 NIH/NCCAM-funded     study aimed to complete the development and pilot a new substance abuse treatment protocol     utilizing drumming for American Indians/Alaska Natives with substance use disorders. The     study includes activities to complete the protocol, followed by a randomized-controlled     clinical trial.   "
147266|NCT01356654|"     This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the     recovery of postural control in stroke rehabilitation.   "
147267|NCT01356641|"     Appendectomy for acute appendicitis has recently been questioned as being the only correct     treatment for appendicitis. Appendectomy has been reported to have significant early and late     morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of     life and lower costs have been associated with antibiotic treatment alone. Five clinical     trials in selected patients (males, older than 18 years) comparing appendectomy and     antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone     is safe and effective in 48-95% of the patients Conclusive evidence with regard to the     efficacy of antibiotic treatment alone in children with proven acute appendicitis however is     lacking. We propose a prospective cohort study to answer the following questions:   "
147268|NCT01356628|"     This is a Phase 2 Study of PD-0332991 in the treatment of patients with Advanced     Hepatocellular Carcinoma (HCC), a type of adenocarcinoma and the most common type of liver     tumor. PD-0332991 is a compound that stops the tumor cell from entering the Synthesis phase     of the cell cycle, therefore stopping DNA multiplication and decreased tumor cell copying.   "
147269|NCT01356615|"     Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as     anticoagulation during hemodialysis (HD) therapy. In this study the investigators have     compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.   "
147270|NCT01356602|"     This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison     to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent     flares of acute gouty arthritis.   "
147271|NCT01356589|"     This retrospective observational study will assess the incidence of hemoglobin cycling in     chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera     (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a     9-month treatment period.   "
147272|NCT01356576|"     The purpose of this study is to determine if there is a drop in platelet count after     hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in     platelets and sometimes in white blood cells. The investigators are going to study one of the     membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.   "
147273|NCT01356563|"     The investigators propose that pharmacist interventions would reduce the amount of unresolved     medication-related problems in hemodialysis patients.      Condition:Hemodialysis patients      Intervention:Behavioral,Pharmacist intervention      Study Design:Randomized Allocation      Control: Active Control      Endpoint Classification: Efficacy Study      Intervention Model: Parallel Assignment      Masking: Double Blind (Caregiver, Outcomes Assessor)      Primary Purpose: Treatment   "
147274|NCT01356550|"     This open-label, single-dose, parallel group study will assess the pharmacokinetics and     safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic     hepatic impairment. Patients and healthy volunteers will receive a single oral dose of     RO4917838.   "
147275|NCT01356537|"     The purpose of this study is to proof increasing patient satisfaction and preservation of     quality of life in patients with Gaucher's Disease receiving their enzyme replacement therapy     with VPRIV (Velaglucerase alfa)at their home setting compared to receiving the infusions at     the clinic or at doctor's practice.   "
147276|NCT01356524|"     In Assisted Reproductive Techniques (ART) there is a need for luteal support using     progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of     administration and dose has not yet been determined.      The aim of the study is to investigate whether high levels of mid-luteal serum progesterone     are related to higher pregnancy rates in ART cycles. We also plan to investigate whether     using higher doses of vaginal progesterone results in higher pregnancy rates.   "
147277|NCT01356511|"     The project was undertaking by Qilu Hospital of Shandong University and other 11 well-known     hospitals in China. In order to report the efficacy and safety of high-dose dexamethasone     compared to conventional dose prednisone for the first-line treatment of adults with primary     immune thrombocytopenia(ITP).   "
148001|NCT01347034|"     The purpose of this study is to determine if injection of the participant's our own immune     related white blood cells (called dendritic cells) into their tumor will strengthen their     immune system to fight against their cancer.   "
147279|NCT01356485|"     Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells are     discoid and can deform and move through small blood vessels to carry oxygen to all parts of     the body. In sickle cell disease, as red blood cells circulate and oxygen is released in the     circulatory system, the deoxygenated abnormal hemoglobin S can begin to polymerize. When this     occurs, the red blood cells can become sticky and elongated. These sickled red blood cells     are less flexible and will obstruct small blood vessels and block normal red blood cells from     traveling through the circulatory system, which limits oxygen delivery to tissues and organs.     This is known as a sickle crisis.      Patients suffering from a sickle crisis experience severe pain and are at risk of stroke,     heart attack or even death. By lowering the level of oxygen pressure at which sickling occurs     and opening the vasculature and rapidly delivering oxygen directly to ischemic tissues, the     addition of MP4CO to existing treatment protocols may alleviate pain associated with a sickle     cell crisis, abort a crisis and/or potentially reduce the duration of a crisis. This could     mean less time in the hospital and an improved quality of life for patients with sickle cell     anemia.   "
147280|NCT01356472|"     As previous studies showed that the synergy between linezolid and carbapenem in vitro and in     vivo (animal studies), our study is aim to investigate the activity of linezolid, alone and     in combination with carbapenem against methicillin-resistant Staphylococcus aureus (MRSA) in     ventilator-associated pneumonia (VAP) patients.   "
147281|NCT01356459|"     The study is designed as a randomised controlled trial of trauma patients admitted to the     Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the     Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly     allocated to either the control group that will receive usual pressure ulcer prevention     strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum     dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in     the ED.      Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate of     sacral and heel pressure ulcer development than patients receiving standard care.   "
147282|NCT01356446|"     The study investigates the impact of the implementation of a surgical checklist on the     mortality 30 days and 90 days after surgery. Patients scheduled for elective surgical     procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible. Surgery is     performed in a single tertiary care center. The study is an open trial before and after     intervention (implementation of the checklist safe surgery saves lifes).   "
147283|NCT01356433|"     Subclinical inflammation is a common phenomenon in patients receiving maintenance     hemodialysis (MHD). This is because various pro-inflammatory cytokines are promoted due to     metabolic acidosis, volume overload, and / or non-sterile dialysate.      As important antioxidants, vitamin C was prominently consumed by oxidative stress and     inflammation. So patients receiving dialysis therapy usually had a low plasma vitamin C     level.      It was documented that inflammation was associated with increased risk of cardiovascular     morbidity and mortality in patients on dialysis. But the relationship between plasma Vitamin     C and each of inflammatory markers and prealbumin was lacking. Because vitamin C had     anti-inflammation effect on behalf of its electron receiving ability, the investigators made     a hypothesis that vitamin C supplementation can reduce inflammation status in patients on     maintenance dialysis   "
147284|NCT01356420|"     The purpose of this study is to learn about Smith-Lemli-Opitz Syndrome (SLOS). SLOS is an     inherited condition that is caused by the body not making an enzyme as it should. The body     needs the enzyme to help make cholesterol. SLOS can cause many health problems including slow     growth and development, eating disorders, sleep disorders, behavior disorders, and eye     diseases. Severe SLOS leads to birth defects and mental retardation and in many cases early     death. The investigators plan to measure cholesterol and other sterol levels, perform     clinical observations, whole body testing and imaging (brain MRIs), to learn more about the     disease and its progression, differences in the clinical features among individuals with     SLOS, and look at the effect of cholesterol supplementation in this condition.      The study is an interventional study to characterize disease progression and correlations     between clinical, biochemical and physiological features of the disease. The main hypothesis     is that dietary cholesterol supplementation does not improve features of SLOS related to the     brain (e.g. IQ, behavior).   "
147285|NCT01356407|"     Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or     polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its     effectiveness, tolerability and safety.   "
147286|NCT01356394|"     Metabolic syndrome (MS) is a clustering of risk factors for cardiovascular disease (CVD) such     as hypertension, hypertriglyceridemia, low HDL-cholesterol levels, disorders of glucose     metabolism, and insulin resistance. A number of associated conditions are included in the MS     spectrum such as abdominal obesity, systemic inflammatory activation, endothelial     dysfunction, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome,     and microalbuminuria. As a consequence, the diagnosis of MS identifies patients who are at     increased risk for type 2 diabetes mellitus and CVD. In the last few years, the potential for     MS to trigger renal damage and accelerate the progression of pre-existing nephropathy has     become a focus of research. Some studies have suggested that MS can influence the development     of CKD, although the underlying mechanisms are not well understood. In this study, the     investigators hypothesized that modifying a key component of the MS, namely obesity, could     attenuate renal damage. The investigators examined the impact of weight loss on creatinine     clearance and urinary albumin excretion in non-diabetic obese patients with MS.   "
147287|NCT01356381|"     The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to     placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with     metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic     euglycemic clamp.   "
147288|NCT01356368|"     The study aims at piloting the concept of customization of chemotherapy based on molecular     markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤     2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or     compare individual regimen but rather it will test the approach of customization concept as a     whole.      The results of this pilot study will help in designing more definitive trials in our patient     population.   "
147290|NCT01356342|"     This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects     aged between 6 months old to 18 years old. All participants will be divided into three age     cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL     vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2     doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years     will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the     time of vaccination, solicited local and systemic reactions within 7 days after each     vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood     samples will be collected from each subject immediately prior to, and 4 weeks after each     vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO     haemaglutination inhibition reference technique. The analysis will be observer-blinded. All     participants will be followed, either by clinical visit or by telephone contact, for 6 months     after the first vaccination for safety reasons.   "
149180|NCT01331460|"     The purpose of this study is to determine how drug abuse treatment interventions can be     integrated with established Human Immunodeficiency Virus prevention approaches to optimize     their combined effectiveness.   "
147291|NCT01356329|"     Prophylactic treatment will start from surgery until the patients are discharged from the     hospital(18). Then each patient will have 2 follow up visit in gyne- oncology clinic. The     first visit will be 2 weeks from discharge & the second visit will be 3 months after surgery.     In each visit patient will be evaluated for any evidence of thrombo-embolic events clinically     & radiologically if needed ( spiral CT, V/Q scan & lower limp Doppler ). Any side effect or     adverse reaction will be reported & it will be evaluated if it is related to the drug used or     not.   "
147292|NCT01356316|"     Each potential subject will be screened before the start of the study to determine their     eligibility for participation. Just prior to vaccination, a 10 mL venous blood sample will be     taken from each eligible subject, for baseline titration of circulating anti-HA antibodies.     Immediately thereafter, each subject received one dose of vaccine (0.5 mL) by intramuscular     injection into the upper arm. Subjects will be asked to stay at the site for 30 minutes     post-vaccination to observe for immediate reaction. Subjects will be monitored for adverse     events during the study. At three weeks (±3 days) after the vaccination, subjects will be     asked to return to the site for final collection of blood samples.   "
147293|NCT01356303|"     This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients     with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical     City, Riyadh.      Sub-sites will be open for patient accrual in selected centers in the Kingdom.   "
147294|NCT01356290|"     Patients with relapsed medulloblastoma have a very poor prognosis whether treated with     conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or     combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment     option in solid malignancies. The frequent, metronomic schedule targets both proliferating     tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators     will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs     (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide     and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and     liposomal cytarabine. The aim of the study is to extend therapy options for children with     recurrent or progressive medulloblastoma, for whom no known curative therapy exists, by     prolonging survival while maintaining good quality of life. The primary objective of the     MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these     heavily pretreated children and young adults. Additionally, progression-free survival (PFS),     overall survival (OS), as well as feasibility and toxicity will be examined.   "
147295|NCT01356277|"     The broad aim of the proposed study is to improve medication adherence in adolescent kidney     transplant recipients. The investigators hypothesize that a multi-component intervention will     improve medication adherence in the adolescent kidney transplant population. The specific     aims are to determine, in a randomized clinical trial, the efficacy of a structured,     multi-component intervention in improving adherence to anti-rejection medications and graft     outcomes, and to identify characteristics of healthcare systems that are independently     associated with adherence.   "
147296|NCT01356264|"     Despite advances in surgical care, the incidence of postoperative complications and prolonged     recovery following colorectal surgery remains high. Efforts to improve the recovery process     have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural     blockade) and post-operative periods (eg, fast track early nutrition and mobilization. The     pre-operative period may in fact be a better time to intervene in the factors that contribute     to recovery. The process of enhancing functional capacity of the individual in anticipation     of an upcoming stressor has been termed prehabilitation. Based on the notion that     preoperative exercise would have an impact on recovery of functional capacity after     colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup     analysis identified that patients whose functional exercise capacity improved preoperatively,     regardless of exercise technique, recovered well in the postoperative period. However,     one-third of patients deteriorated preoperatively despite the exercise regimen, and these     patients were also at greater risk for prolonged recovery after surgery. These results     suggested that exercise alone is not sufficient to attenuate the stress response in all     patients. In the present trial, the impact of a multimodal prehabilitation intervention     composed of exercise, nutritional supplement and psychological well-being begun in the     preoperative period will be compared to one begun in the postoperative period.   "
147297|NCT01356251|"     The aim of this study is to learn about how mesothelioma affects patients' emotional and     physical well-being. Also, the investigators would like to learn more about what patients     need and how they deal with this illness. This information can help us find ways to lessen     physical and emotional strains. Part of the study tests an alternate way of giving emotional     support through the Internet. By providing support online, patients can participate in the     comfort of their home.   "
147360|NCT01355419|"     In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor.     The investigators can suppose that with continuous positive airway pressure (CPAP) therapy,     there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep     schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The     investigators have planned to study sleep schemes before and after CPAP therapy in moderate     to severe sleepy OSA patients.   "
147298|NCT01356238|"     Quality-controlled commercial media have been used in many in-vitro fertilization (IVF)     laboratories. However, commercial media are costly and difficult to compare directly because     their exact compositions are not clearly indicated. Although commercially available media     have commonly been used in most IVF programs worldwide, there are several advantages to the     use of in-house synthetic sequential media at IVF laboratories. First, the results of quality     control should be reliable due to a stringent protocol setting-up. Second, any direct     supplementations or deletions of specific components are feasible to obtain good quality     embryos and high pregnancy rates since those components can be defined. Finally, dependence     on commercially available media diminishes so that the laboratory can more easily accommodate     unexpected situations or problems, such as a sudden increase in IVF patients. Therefore, the     present study was conducted to compare the efficacy of in-house MRC media in the human     IVF-embryo transfer (ET) program to that of commercially available media.   "
147299|NCT01356225|"     The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN)     administration of ketorolac after dental impaction surgery.   "
147300|NCT01356212|"     This was a randomised three-way crossover design study. The study consisted of three study     periods each separated by a minimum 44 hour washout period. During the course of each study     period, scintigraphic images were acquired at planned intervals after dosing. Subjects were     able to leave the clinical unit after the completion of study specific procedures at 6 hours     post-dose.      The primary objective of the study was to determine whether any of the radiolabelled     ketorolac formulation was deposited in the lungs of healthy volunteers following nasal     inhalation under three different conditions (gentle sniff-inhalation with subject standing,     vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject     semi-supine). The secondary objectives were to determine the deposition pattern of     radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a     six-hour period.   "
147301|NCT01356199|"     The purpose of this study is to determine whether the nutritional supplement ARTRONAT     improves the quality of life of patients with osteoarthritis.   "
147302|NCT01356186|"     The broad objective of this research is to effectively utilize a unique window of opportunity     during the hospitalization period following a recent suicide attempt to deliver a brief and     targeted intervention for traumatized individuals.   "
147303|NCT01356173|"     This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,     tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).   "
147304|NCT01356160|"     This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response     Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a     and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus     Infection.   "
147305|NCT01356147|"     To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator     associated pulmonary infections. Dornase alfa has been effective in the treatment of     pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria     causing pulmonary infections in cystic fibrosis patients is similar to those infecting     preterm infants. The investigators expect that dornase alfa therapy will improve recovery     from ventilator associated pulmonary infections in preterm infants.   "
147306|NCT01356134|"     The investigators propose that evidence of chronic cerebrospinal venous insufficiency (CCSVI)     may be evident in the vasculature of the fundus. The investigators will be examining fundi of     multiple sclerosis patients and Ehlers-Danlos patients to see if evidence of CCSVI can be     found in these patients having high risk for CCSVI. The investigators will read the fundus     photos, compared to age-matched normals in a blind fashion.   "
147307|NCT01356121|"     To compare effects of sedation for upper gastrointestinal endoscopy with propofol and     midazolam on psychometric tests and critical flicker frequency (CFF) in cirrhotics   "
147308|NCT01356108|"     The purpose of this registry is to retrospectively and prospectively obtain clinical data in     consecutively treated patients, in order to demonstrate that the commercially available     Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for     patients with pulmonary regurgitation or stenosis.   "
147309|NCT01356095|"     Despite increased emphasis on evidence based practice in recent years a gap remains between     evidence and practice, particularly in resource poor countries. Few studies to date have     examined the use of knowledge translation strategies to improve health care outcomes in low     income countries. However, given that the majority of health care in these settings is     provided by workers with less training and limited resources, the theoretical potential for     knowledge translation strategies to improve health care delivery and outcomes by integrating     best evidence into routine practice may be greatest in these settings.      Knowledge translation (KT) is an approach to changing health care provider behavior to reduce     the gap between evidence and practice in health care delivery. There has been a tendency for     knowledge translation interventions to employ generic, off the shelf, strategies, and apply     them to deal with specific issues. This generic approach, fails to recognize the variability     in the specific characteristics of health care settings, in terms of their patient     populations, health care systems, and health care providers. These characteristics, whether     they function as barriers or facilitators to change, make a generalized approach to KT     ineffective, where a tailored strategy, which specifically adjusts its approach to measured     local barriers and facilitators may achieve better alignment of practice to evidence. This is     likely to be particularly true in low income countries where the majority of health care is     provided by non-physician health care workers, working within a wider range of health care     systems, with variable and unique patient populations and resource constraints. Given the     potential to significantly impact health care outcomes at relatively low cost, further     research is needed both to develop methods for identifying potential barriers and     facilitators to KT strategies in specific resource poor settings, and to evaluate the     effectiveness of KT strategies tailored to address the identified barriers.      This study will assess the effectiveness of a two part knowledge translation intervention     tailored to address factors identified in a previous study as functioning as barriers and     facilitators to treatment adherence among patients on treatment for tuberculosis or combined     tuberculosis and antiretroviral treatment, targeting improved patient adherence and health     outcomes, in a specific low income country.   "
147310|NCT01356082|"     A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™     Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings     and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical     decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we     will test it during the perioperative care of children.   "
147361|NCT01355406|"     This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to     cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal     artery. The arteries are often abbreviated as femoropopliteal.      The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding     Stent System is safe and effective for the treatment of patients with peripheral arterial     disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy     performance goals established for Femoropopliteal bare nitinol stents in patients with     symptomatic peripheral arterial disease.   "
147323|NCT01355913|"     In myelodysplastic syndromes (MDS) the knowledge about chromosomal aberrations is important     for diagnosis, pathogenesis, prognosis and treatment. Usually, chromosomal anomalies in MDS     patients are detected in bone marrow cells by chromosome banding analyses of metaphases.     Alternatively or additionally they can be diagnosed by Fluorescence-in-Situ-Hybridization     (FISH). The investigators here present a novel method for cytogenetic monitoring of MDS     patients from peripheral blood which is representative for the clone size in bone marrow     cells. The purpose of this prospective multicenter non-interventional diagnostic study is to     detect and to follow chromosomal aberrations from peripheral blood closely, to assess     karyotype evolution, to detect rare abnormalities and to correlate the molecular-cytogenetic     results with peripheral blood counts, bone marrow morphology and treatment modalities and     responses.   "
147324|NCT01355900|"     Different strategies of tourniquet application during elective primary total knee     arthroplasty are thought to be associated with different outcomes. In that context, the study     investigates different tactics in the search of optimal application of the tourniquet and the     related fluid management during 24 perioperative hours.   "
147311|NCT01356069|"     Subjects affected with severe Borderline Personality Disorder (BPD) are often heavy users of     Mental Health Services (MHS). This study evaluates the efficacy of the addition of Sequential     Brief Adlerian Psychodynamic Psychotherapy (SB-APP) to the treatment-as-usual (TAU) for BPD     compared to the TAU alone for a naturalistic group of heavy MHS users with BPD. The efficacy     was evaluated after at 6 time points along a two years of follow-up.      Thirty-five outpatients eligible for the study were randomly assigned to two treatment groups     (TAU=17; SB-APP=18). The Clinical Global Impression (CGI) and the CGI-modified (CGI-M) for     BPD, the Global Assessment of Functioning (GAF), the State-Trait Anger Expression Inventory     (STAXI), and the Symptom Checklist-90 Revised (SCL-90-R) were administered at T1, T3, T6,     T12, T18, and T24. At T12 also the Working Alliance Inventory-Short Form (WAI-S) was     filled-in by participants and compared between groups. In the one-year follow-up the SB-APP     group did not receive any individual psychological support. MHS was specifically trained in     BPD treatment and had regular supervisions.      Scores of the CGI, GAF, and STAXI improved after 6 and 12 months, irrespective of treatment.     SB-APP group displayed a better outcome for impulsivity, suicide attempts, chronic feelings     of emptiness and disturbed relationships. The results displayed a good stabilization during     follow-up year even after the interruption of psychotherapy in the SB-APP group.      Even though the TAU for BPD applied to heavy MSH users displayed some efficacy in reducing     symptom expression and improving global functioning, the adjunct of a specific time-limited     and focused psychotherapeutic treatment reached a better outcome. In particular the     possibility of a focus on patients' personality functioning (SB-APP) with a specific     psychotherapeutic approach seemed to be more effective than the general support to social     impairment offered by the TAU approach.   "
147312|NCT01356056|"     The purpose of this research study is to design, implement, and clinically assess a portable,     user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard     in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective,     qualitative ranking system. The main goal of this research is to develop a quantitative     system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a     home based system which can capture those symptom changes over the course of a day and aid in     evaluating treatment protocol efficacy.   "
147313|NCT01356043|"     The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of     S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine     monotherapy.   "
147314|NCT01356030|"     The two most commonly used methods to biopsy suspected pancreaticobiliary masses are (1)     endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) and (2) cytology brush biopsies     obtained during endoscopic retrograde cholangiopancreatography (ERCP). At most centers, the     specific method used depends on the availability of the technology and local expertise.     Although it is believed that EUS-FNA is more accurate than ERCP brushings, there have been no     head-to-head comparisons. The investigators' hypothesis is that EUS-FNA is superior to ERCP     in obtaining tissue biopsies of pancreaticobiliary tumors, and the investigators aim to     directly compare the two techniques.   "
147315|NCT01356017|"     The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of     Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan     monotherapy.   "
147316|NCT01356004|"     Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis     may be difficult and cyclosporine can induce some remission.      The investigators hypothesized that the combined use of live attenuated varicella vaccine as     an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis     can give positive responses.   "
147317|NCT01355991|"     To determine the acute and chronic effects of a short course of treatment on spinal cord     injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂     agonist (Salmeterol) on:        -  Fraction of expired NO (FeNO)        -  Selected Biomarkers of inflammation in exhaled breath condensates (EBC)        -  Pulmonary function, as measured by pulmonary function tests and body plethysmography   "
147318|NCT01355978|"     When using the Breathe Technologies Ventilation System during simulated activities of daily     living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD)     will be comfortable and report acceptability.   "
147319|NCT01355965|"     To determine the safety and manufacturing feasibility of IV autologous chimeric immune     receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a     single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell receptor     domain and the 4-1BB costimulatory domain.   "
147320|NCT01355952|"     The aim of this study is to collect pilot data to compare the effectiveness of treatment with     Alpha Lipoic Acid (ALA) for reduction in body weight in 40 obese outpatients with     schizophrenia or schizoaffective disorder in an open-label pilot trial. The investigators     also plan to test the feasibility of utilizing ALA as a weight loss agent for obese     outpatients with schizophrenia or schizoaffective disorder in terms of tolerability,     schizophrenia symptoms, cognition and side effects. We have run a total of 12 non-diabetic     participants and are now recruiting diabetic patients in hopes of comparing the two groups.   "
147321|NCT01355939|"     The proposed study will compare the benefits, harms, and comparative effectiveness of     intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in     reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual     patient subpopulations and clinical circumstances. A subset of the data will be analyzed to     compare the benefits, harms, and comparative effectiveness of the laparoscopic and open     approaches to adhesiolysis. A comprehensive array of health-related risk factors and     patient-centered outcomes will be assessed in the investigators diverse patient population     for proper multivariate data analysis.      Specific Aim I: To evaluate and compare the adhesion characteristics of intraperitoneal     barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior     ventral hernia repair.      Specific Aim II: To evaluate and compare the adhesion-related complications and     adhesiolysis-related complications of intraperitoneal barrier-coated versus     non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.      Specific Aim III: To determine the comparative effectiveness of intraperitoneal     barrier-coated versus non-barrier-coated ventral hernia repair mesh in reducing adhesions,     adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations     and clinical circumstances.      Specific Aim IV: To evaluate and compare the adhesiolysis-related complications of the     laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior     ventral hernia repair.      Specific Aim V: To determine the comparative effectiveness of the laparoscopic and open     approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair.   "
148002|NCT01347021|"     The purpose of this study is to compare the vaginal sacrospinous colpopexy and high     uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with uterus.   "
147325|NCT01355887|"     The purpose of this study is to better comprehend the benefits and efficacy of portal triad     clamping with infrahepatic IVC clamping during complex hepatectomy. A randomized comparative     trial was performed to compare PTC(pringle triad clamping) with either infrahepatic IVC     clamping or low central venous pressure in complex liver resections.   "
147326|NCT01355874|"     Primary Objective:      To evaluate the effect of iferanserin ointment on cessation of bleeding when administered     intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal     hemorrhoids.      Methodology:      Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group,     placebo-controlled part of the study. Extension: Multicenter, open-label part of the study.      Study Treatment Duration:      Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12     months (open-label part of the study in which there will be a scheduled visit every three     months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be     treated with open-label iferanserin for 7 days followed by a 21-day follow-up period).      Criteria for Evaluation:      Primary Endpoint:      The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the     remainder of the treatment period (through Day 14).   "
147327|NCT01355861|"     The purpose of this study is to determine the benefits of negative work progressive     resistance exercise (PRE) for the conservative management of sarcopenia in older male     Veterans at the DC VAMC. Efficacy will be assessed by examining post-exercise changes in     metabolic and inflammatory markers, muscle morphology, strength, and functional status.   "
147328|NCT01355848|"     The aim of the study is to refine, elaborate, and pilot a brief intervention for adult     patients following a suicide attempt provided during hospitalization in an acute medical     setting. 40 participants will be randomized to receive the brief intervention + care as usual     or only care as usual. It is hypothesized that the intervention will be acceptable and     feasible to both patients and intervention clinicians.   "
147329|NCT01355835|"     12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best     individual subthalamic nucleus stimulation and dopaminergic medication will be included into     this randomised double-blind cross-over two-armed clinical trial. The treatment consists of     two different stimulation settings using (i) conventional stimulation of the subthalamic     nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the     subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata     [STN+SNr].   "
147330|NCT01355822|"     Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical     underlying placental pathology revealing small placentas and maldevelopment of the decidual     blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide     (NO) donors can improve decreased uteroplacental perfusion without any negative effects on     fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.      The aim of this study is to evaluate the effectiveness of the long-lasting NO donor     pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes     (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm     delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid     gestation.   "
147331|NCT01355809|"     The purpose of this study is to evaluate effects of inspired gas mixtures on the distance     walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a     Six-Minute Walk test.   "
147332|NCT01355796|"     Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and     recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt     concentration has been shown to increase activity of salt sensitive antimicrobial peptides.      Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate     immunity.In this study, the investigators plan to study the safety and efficacy of 2 weeks of     inhaled xylitol compared to 2 weeks of hypertonic saline in a randomized crossover design in     stable subjects with cystic fibrosis   "
147333|NCT01355783|"     The purpose of this study is to evaluate whether treatment of E7777 in combination with CHOP     has superior efficacy compared with CHOP alone in improving complete response rate (CRR) in     first line treatment of subjects with Peripheral T-cell Lymphoma (PTCL).   "
147334|NCT01355757|"     Randomized controlled trial on efficacy of single injection or continuous interscalene     brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.   "
147335|NCT01355744|"     About spider bites in Middle Europe, there are published only a dozen cases. The     investigators suspect that they may be much more frequent than reflected by the literature     analysis (but much less dangerous than thought by people). From June 1st 2011 to November     30st 2012 the investigators collect clinical data on patients treated for spider bites in     Switzerland.   "
147410|NCT01354756|"     Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric     surgery. There is a need for alternative screening tools for sleep apnea detection in the     pre-operative period. The investigators would like to compare ApneaLink and complete     polysomnography in this population.   "
147336|NCT01355731|"     Professional therapeutic boundaries are defined as the limits that protect the space between     a professional's power and patient's vulnerability. It is important to develop therapeutic     alliances while maintaining boundaries, thus ensuring nurses develop safe connections with     patients and their families based on therapeutic needs. Due to the professional nature of     nursing, boundary violations are common. For example, closeness and familiarity develops     between the healthcare provider, patient, and caregiver that encompass the physical,     emotional, and spiritual realms. This provides an opportunity for intense bonds with patients     and families. Furthermore in oncology healthcare, providers deliver compassionate care and     empathize with patients and families while sharing in the patient's illness journey. As a     result of these bonds and relationships the nurse may over disclose personal information,     provide excessive patient attention, meeting their own personal needs instead of the patient     and family. In addition, continuity of care contributes to boundary crossings because there     is frequent repeated contact with the same patients and families which allows blurring of     boundary lines. When staff spend weeks, months, or even years with the same patient the     opportunity to connect and talk about personal life details exist. At the national level, the     National Council of State Boards of Nursing (NCSBN) has created materials for educating     nurses in maintenance of therapeutic boundaries. Adherence to therapeutic boundaries has now     become an education objective, with the development of educational interventions within many     health care settings. Likewise, St. Jude nurses are at an increased risk of crossing     therapeutic boundaries due to long term care relationships and vulnerable family members.     However, nursing administration has not formally assessed the attributes or behaviors of the     nursing staff. This proposal will describe the attributes and behaviors of the St. Jude staff     nurse towards nurse-patient/family boundaries, providing knowledge to nursing leadership that     will facilitate therapeutic boundaries focus groups with direct care nurses.   "
149181|NCT01331447|"     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under     fasted conditions   "
147337|NCT01355718|"     This trial is conducted in Asia. The primary objective of this study is to evaluate the     clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue     combination therapy in type 2 diabetes under normal clinical practice conditions in Korea     while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of     NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical     practice conditions in Korea.   "
147338|NCT01355705|"     To assess if amrubicin is safe and useful for patients with multiple myeloma requiring     additional treatment.   "
147339|NCT01355692|"     The population of people suffering from diabetes is rapidly increasing, from an estimated 110     million in 1994 to 221 million in 2010. Diabetic macular edema is the most common reason for     reduction in visual acuity in diabetic patients.      The standard care for diabetic macular edema is focal and /or grid retinal photocoagulation.     During photocoagulation, small laser burns are applied to the retina, the sensory tissue that     lines the back of the eye. Studies have shown that photocoagulation of clinically significant     diabetic macular edema substantially reduces the risk of visual loss, increase the chance of     visual improvement and decrease the frequency of persistent macular edema. However, it     remains unknown whether the destruction of sensory layer of the retina during     photocoagulation that may cause visual field defects is necessary for successful treatment or     is just an unwanted and unnecessary side effect.      Based on these concept, a photocoagulation technique was developed to treat the retina     selectively (SRT - Selective retinal therapy), with minimal or no damage to the sensory     layers. While the treatment is very similar to regular photocoagulation, the SRT laser uses     much lower energy and very short pulses. As a result, treatment does not result in visible     burns to the retina and previous studies have shown that the sensory layer remains intact.      The aim of this study is to determine the effect of SRT on the resolution of the edema.   "
147340|NCT01355679|"     The purpose of this study is to test the feasibility (ability to be done) of an experimental     test to help plan your cancer treatment. This study plan is not studying the effectiveness of     the proposed combinations of therapy for your cancer that you may receive after the     experimental testing.      This study will look at an experimental technology to determine a tumor's molecular makeup     (gene expression profile). This technology (called OncInsights) is being used to discover     new ways to understand cancers and potentially predict the best treatments for patients with     cancer in the future. The experimental technology has not been approved by the U.S. Food and     Drug Administration.   "
147341|NCT01355666|"     The primary purpose of this research study is to evaluate if DermaTherapy® bedding will     significantly reduce pressure ulcer incidence by decreasing maceration, friction, and     shearing among residents of Nursing Homes.   "
147342|NCT01355653|"     This study is designed to compare the safety, as measured by skin findings and adverse     events, of two different heat devices in elderly, overweight, and elderly and overweight     subjects.   "
147343|NCT01355640|"     1. The purpose of this study is to research and compare two sucking modes'          effect(breast-feeding and non-nutritive sucking) and difference,hypothesis is that these          two kinds of methods can decrease pain for Chinese term infants receiving heel stick.        2. A convenient sample of 90 neonates from a hospital in Beijing undergoing heel stick for          Newborn Screening Program Blood Test were enrolled. They were randomized into three          groups:             -  breast-feeding group             -  non-nutritive sucking group             -  control group        3. The results showed that:             -  Breast-feeding can reduce crying and grimace time, increase oxygen saturation.             -  Non-nutritive sucking can delay grimace's starting time, increase oxygen               saturation.   "
147344|NCT01355627|"     The primary objective is to demonstrate superiority of TachoSil® compared to current practice     as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be     evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as     an adjunct in sealing the dura mater.      The trial population will consist of 726 randomised (1:1) patients elected for skull base     surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1     weeks and safety follow-up 28±2 weeks after surgery.   "
147345|NCT01355614|"     This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's     disease.   "
147346|NCT01355601|"     This clinical trial will determine the effect of varying types of carbohydrates on children's     concentration.   "
147347|NCT01355588|"     This was a phase 1, double-blind, 4-way crossover study in healthy male and female     volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg.     There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects     were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine     alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine     hydrochloride. At the end of the study each subject had received all 4 treatments.      The primary objective of this study in healthy volunteers was to compare the safety,     tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary     objective was to monitor lidocaine hydrochloride plasma levels.   "
147348|NCT01355575|"     TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Proof-of-principle, open-label,     randomised, cross-over, controlled study HYPOTHESIS Reduction in gut flora by the antibiotic     Rifaximin reduces hepatic inflammation in Non-Alcoholic Steatohepatitis (NASH).      AIMS To provide proof-of-concept data on the therapeutic potential of gut flora modification     in NASH OUTCOME MEASURES      Primary:      • Change in serum ALT from baseline by 25 IU/L or to within normal range after 6 weeks of     therapy      Secondary:        -  Change in intrahepatic triglyceride, estimated by in vivo proton magnetic resonance          spectroscopy (1H MRS)        -  Change in hepatic insulin resistance, estimated by the hyperinsulinaemic euglycaemic          clamp        -  Changes to the faecal bacterial microbiome assessed by faecal DNA pyrosequencing and          fluorescent in-situ hybridisation (FISH)        -  Differences in urinary metabolic profiles as assessed by high-resolution proton nuclear          magnetic resonance spectroscopy      POPULATION Patients with biopsy-confirmed non-alcoholic steatohepatitis and persistently     raised serum aminotransferase levels      TREATMENT The non-absorbable antibiotic Rifaximin DURATION Study duration 18 months.     Individual patients' participation 18 weeks, with clinical follow-up 3 months after the end     of the study.   "
147349|NCT01355562|"     The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.   "
147350|NCT01355549|"     Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by     overuse injuries to the muscles and tendons that can occur during wheelchair propulsion,     transfers, and other activities of daily living. Normally, shoulder pain resolves with     conservative treatments such non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen,     naproxen, etc.) and physical therapy. However, when these treatments fail, shoulder surgery     may be the only option.      Platelet Rich Plasma therapy, or PRP, is a treatment option for non-healing muscle and tendon     injuries such as those that cause shoulder pain in persons with SCI. Using one's own blood,     cells within the blood called platelets are concentrated and then re-injected into the     muscle and tendon of the shoulder. These platelets release substances known as growth     factors that lead to tissue healing. By concentrating the platelets we increase the growth     factors up to eight times which will promote the healing of tendons. PRP therapy has shown     promise in treating tendon and muscle injuries in able-bodied persons; however, its     effectiveness in persons with SCI is unknown. The purpose of this study is to explore the     feasibility, safety, and efficacy of PRP therapy for chronic shoulder pain in persons with     SCI. The human body has a remarkable ability to heal itself and we hypothesize that     re-injecting concentrated platelets will facilitate the natural healing process and will     reduce shoulder pain in persons with SCI.   "
147351|NCT01355536|"     The prevalence of preterm birth is rising in most western countries. The causes of preterm     birth is not fully understood and seem to be multifactorial. The endocrine and metabolic     aspects are scarcely investigated.The main purpose of this study is to test the hypothesis     that endocrine and metabolic factors associate to preterm births.   "
147352|NCT01355523|"     The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week     preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive     function and sleep disturbances in breast cancer patients. Furthermore the investigators will     examine whether a specific clock-gene (HPER3) is correlated with an increased risk of     depression, sleep disturbances or cognitive dysfunction.   "
147353|NCT01355510|"     Electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial     pressure in patients with refractory hypertension. The reduction in blood pressure seems to     be mediated through sympathetic inhibition with concomitant reduction in the activity of the     renin-angiotensin system. Indeed, switching on and off the stimulation is accompanied by     decreases and increases in central sympathetic vasoconstrictor outflow, respectively. Plasma     renin concentration also decreases with acute electrical baroreflex stimulation.      In some patients chronic baropacing is associated with long-term blood pressure reduction.      However, there is sparse information as to the relative contribution of blood pressure     regulating systems to account for the acute and chronic effects of baropacing. Sympathetic,     renal, and vascular mechanisms are of special interest. Furthermore, technical aspects of     electrical baroreflex stimulation may play a role, e.g. worsening of the electrical contact     between the stimulating electrodes and the baroreceptor afferents.      This study is designed to answer the following primary questions:        1. Does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic          vasoconstrictor tone also in the long-term?        2. Does sympathetic vasoconstrictor tone increase on switching off chronic baropacing? Such          an increase would confirm electrical integrity of the system and proper contact to the          baroreceptor afferents.        3. Does acute electrical baroreflex stimulation decrease renal vascular resistance?        4. Does acute electrical baroreflex stimulation influence glucose delivery to skeletal          muscle and change insulin sensitivity? The study follows an open-label observational          design and it is planned to recruit up to 30 patients over 3 years.   "
147354|NCT01355497|"     The purpose of this study is to determine if the investigational drug GTx-024 can help     patients with non small cell lung cancer increase physical function and maintain or gain     muscle.   "
147355|NCT01355484|"     The purpose of this study is to determine if the investigational drug GTx-024 can help     subjects with non-small cell lung cancer increase physical function and maintain or gain     muscle, also called lean body mass.   "
147356|NCT01355471|"     This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial     erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied     topically once daily is more efficacious than vehicle and provides an acceptable safety     profile in the treatment of facial erythema associated with rosacea.   "
147357|NCT01355458|"     Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema     associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once     daily is more efficacious than vehicle and provides an acceptable safety profile in the     treatment of facial erythema associated with rosacea.   "
147358|NCT01355445|"     This is an international open-label, randomized, multicenter phase II study of VIT and VI for     the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will     evaluate the safety and efficacy of these combinations in patients with recurrent or     refractory rhabdomyosarcoma.   "
147362|NCT01355393|"     This randomized phase I/II trial studies the side effects and best dose of rintatolimod when     given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in     treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive     breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an     effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies,     such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary     treatment to lower the risk that the cancer will come back and are one way to help vaccines     produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or     GM-CSF may be a safe and effective treatment for breast cancer.   "
147363|NCT01355380|"     This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for     treatment with Ventavis.      Typical clinical measures and quality of life will be prospectively followed in 12 months     period.   "
147364|NCT01355367|"     This is a clinical study evaluating the safety and efficacy of long term administration of     oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for     whom the test drug is tolerable during the 8 week double blind treatment phase of Study     13176.   "
149182|NCT01331434|"     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under     fed conditions.   "
147366|NCT01355341|"     More specifically, the present invention relates to a 'Herbal Preparation' that is useful for        -  Treatment of Renal calculi        -  Reduction in the stone size & surface area        -  The expulsion of stone        -  Decreased need of Analgesic(Antiinflammatory Effect)        -  Stops the recurrence and reformation of renal   "
147367|NCT01355328|"     In this study, the investigators will evaluate the potential of multiphoton microscopy as a     non-invasive imaging modality for monitoring of the radiofrequency-tissue and light-tissue     reaction. The investigators will also investigate drug delivery using multiphoton microscopy.   "
147368|NCT01355315|"     Enhanced external counterpulsation (EECP) is a noninvasive circulatory assist device that has     been as a treatment option for refractory angina in left ventricular (LV) dysfunction.     Recently, its potential role in heart failure management has been shown. However, although     the concept of EECP was introduced almost four decades ago, and despite growing evidence     supporting the clinical benefit and safety of this therapeutic modality, little is firmly     established regarding the mechanisms responsible for the benefit of EECP include improvement     in endothelial function, promotion of coronary collateralization, enhancement of ventricular     function, and peripheral effects. Therefore, the major aim of this study is to provide an     alternative treatment, EECP, for those unsuitable for standard procedures, especially for     patients whose heart failure was caused by repeated myocardial infarction, called ischemic     cardiomyopathy (ICMP), and to evaluate the clinical outcome and the endothelial function     before and after 35 hours of EECP treatment.   "
147369|NCT01355302|"     The purpose of this study is to determine the following: 1. Find the maximum tolerated dose     of E7050 when given in combination with cisplatin and capecitabine in patients with advance     or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and     capecitabine is more effective in patients with previously untreated gastric cancer versus     cisplatin and capecitabine alone.   "
147370|NCT01355289|"     The study will have three phases: Prerandomization, Randomization (Core Study), and     Extension. The Randomization Phase may include Treatment Periods A1 and A2 (depending when/if     subjects enter the open-label extension, and a follow-up period (for those subjects not     continuing into the open-label extension). The open-label extension may include Treatment     Periods B1, B2, and B3 (depending on when subjects enter the open label extension), and a     follow-up period. Subjects may be followed for sustained viral response, if appropriate. In     the Core Study (randomization phase) subjects will be randomized (in a 1:1:1:1 ratio) to     receive one of four treatments (placebo or E5501 [10mg, 20mg, and 30mg] for up to 21 days.     Subjects will successfully complete Treatment Period A1 once their platelet counts are     sufficient to enable initiation of antiviral treatment with PEG-IFN. The open label extension     period will consist of up to three (depending on if/when subjects enter) Open-label Treatment     Periods (B1, B2, and B3) and a follow-up period. During open-label treatment, all subjects     will begin once-daily treatment with E5501 at a dose of 20 mg. In Treatment Periods B2 and     B3, subjects will be allowed to have their E5501 dose titrated up or down in accordance with     their individual response, within the range of a minimum of 5mg and a maximum of 50mg.   "
147371|NCT01355276|"     The purpose of this study is to compare Cinitapride tablets with domperidone tablets     (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment     of mild to moderate functional dyspepsia.   "
147372|NCT01355263|"     The investigators plan to perform a randomized, mutual-control and double-blinded cohort     study to further exploit the vitamin A supplementation on iron metabolic homeostasis     (including iron reserve, mobilization and absorption status in the same population) compared     with solely iron and vitamin A plus iron.   "
147373|NCT01355237|"     This research study is being done to understand the outcomes of back pain treatment and costs     associated with it in an academic hospital outpatient setting. The investigators will conduct     a prospective observational cohort study to assess the clinical outcomes and utilization of     health care services of 175 Osher Clinical Center (OCC) patients with chronic low back pain     (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated within Brigham     and Women's Hospital. Outcomes will include assessment of functional status, symptom relief,     satisfaction with care, health-related quality of life, and worker productivity, and will be     measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3,     6, and 12 months.   "
147374|NCT01355224|"     This study will examine the impact of providing genetic risk information for obesity on     people's attitudes and beliefs about obesity, health behaviors and weight outcomes.     Specifically, this study will examine the feasibility of using genetic information to     motivate efforts to reduce obesity among individuals recruited to the Coriell Personalized     Medicine Collaborative (CPMC), see below for description of CPMC.   "
148006|NCT01346969|"     The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing     skin scarring in subjects undergoing revision of scars from prior surgery. The study will     also evaluate the safety and tolerability of EXC 001 and placebo.   "
147375|NCT01355211|"     The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless     electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying     abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status epilepticus)     in emergency department (ED) patients with altered mental status. Comparing the the accuracy     of EEG recordings and interpretations of Micro-EEG to those of standard EEG will allow the     investigators to assess the utility of this novel device in the ED patients with altered     mental status. The unique qualities of Micro-EEG device could potentially facilitate easier     access to EEG test in all ED patients.      This study will also provide valid information regarding the prevalence of non-convulsive     seizure in ED patients with altered mental status.The gold standard for diagnosing     non-convulsive seizure would be standard EEG.      All study participants will undergo electroencephalography using the two devices (standard     EEG and micro-EEG) and a combination of standard electrodes and Electro-Cap in a randomized     order: 1. Standard EEG with standard EEG electrodes, 2. Micro-EEG with standard EEG     electrodes, and 3. Micro-EEG with Electro-Cap electrodes.   "
147414|NCT01354704|"     The objectives of the study are:      o Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing     ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA      o Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these     patients compared with the original drug Lovenox ®.   "
147376|NCT01355198|"     HIV infection is associated the development of increased oxidative stress and deficiency of     glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms     contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been     studied in HIV patients, in whom the burden of risk factors promoting oxidative stress is     highest. Our previous studies in non-HIV human subjects with diabetes-related oxidative     stress and GSH deficiency have demonstrated that the latter is due to decreased synthesis of     GSH. Importantly, short-term dietary supplementation with the simple GSH precursor     amino-acids cysteine and glycine, boosted GSH synthesis and cellular concentrations,     corrected GSH deficiency, and reduced oxidative stress and oxidant damage. The current     proposal will study whether (1) defective synthesis underlies GSH deficiency in patients with     HIV, and will test a simple, inexpensive and rational therapy based on protein     supplementation to improve GSH synthesis and concentrations and lower markers of oxidative     stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is     asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and     insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry;     (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in     these subjects.   "
147377|NCT01355185|"     There are substantial uncertainties with contemporary seed placement techniques in prostate     brachytherapy, particularly with the impact of seed movement after an implant due to edema     and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20     patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at     specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these     phenomena.   "
147378|NCT01355172|"     The purpose of this study is to evaluate the antibody response to each of the three influenza     vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by     hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart,     in infants between 6 and 12 months of age.   "
147379|NCT01355159|"     The hypothesis of the study is: high dose (4.0 mg per day) supplementation for pregnant women     at high risk of developing preeclampsia starting in early pregnancy and continued throughout     the entire pregnancy will lower the incidence of preeclampsia.   "
147380|NCT01355146|"     The purpose of this study is to proof increasing patient satisfaction and preservation of     quality of life in patients with Morbus Fabry disease receiving their Enzyme Replacement     Therapy with Replagal (Agalsidase alfa) at home compared to receiving the infusions at the     clinic or at doctor's practice.   "
147381|NCT01355133|"     The purpose of this pilot clinical study is to determine if intrasphincteric autologous     myoblast injections in combination with electrical stimulation are safe and effective in     treating stress urinary incontinence, confirming the optimal dose and assessing tolerability     of the procedure.   "
147382|NCT01355120|"     This is an open-label, multi-center, single-arm clinical phase II study to further     characterize the efficacy and safety of ipilimumab in patients with or without systemic     pretreatment metastatic ocular melanoma.      The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because     sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In     order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma     it is mandatory to focus the recruitment to this patient population. Only this will guarantee     a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from     uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE Pathology of ocular     melanomas British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and     treatment procedure as those used before will be applied for the patients with advanced     ocular melanoma. Since no treatment standard in those patients does exist, also patients     without prior systemic treatment can be included in this study. Therefore, the 5th inclusion     criterion has been adapted in order to enrol the eligible patients.   "
147383|NCT01355107|"     The incidence of hepatocellular carcinoma (HCC) is rising worldwide.One important etiology is     a chronic inflammation due to hepatitis c (hcv) infection. Over the steps of a chronic     inflammation over the stadium of cirrhosis of the liver it is possible that neoplastic     nodules appear in the liver which can rise up to a HCC. In the pathogenesis of HCC oxidative     stress seems to play an important role and as selenium is a key micronutrient in this process     its levels could differ between the different stages of disease in hcv- infected patients.     The aim of this trial is to examine these differences.   "
147411|NCT01354743|"     The purpose of this study is to provide data to support combination treatment of the upper     face with Perlane-L® and Dysport™. This study will assess the outcome of upper face     rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also     be assessed as a secondary endpoint.   "
147486|NCT01353768|"     GSK is conducting a global retrospective chart review of patients treated with zanamivir as     part of the Compassionate Use Program (CUP), in an effort to collect as much information as     possible on the use of this investigational drug. The retrospective chart review is intended     to gain a better understanding of the safety profile of investigational zanamivir and of     clinical outcomes in the large number of patients treated outside of a clinical trial     setting.   "
147397|NCT01354925|"     Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for     all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can     induce harmful effects and complications in patients with diabetes. Several studies have     demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during     fasting. When treating diabetic patients with a treatment guideline the rate of these     complications can be reduced. Little data is available on patients with type 2 diabetes     treated with insulin. The investigators therefore propose to assess the effect of a protocol     containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in     patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard     care patients receive during this period. The investigators assume that patients receiving     the intervention will have better glucose control during the Ramadan compared to patients     receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes     and most of them fast during the Ramadan the results of this intervention may be significant     and may improve the care of these patients allowing Muslims to respect their religious     obligations without compromising their health.   "
147384|NCT01355094|"     This pilot study will evaluate the effectiveness in actively removing the peritoneal fluid     through the use of a commercial suction device compared to passive drainage of the same     peritoneal fluid drained through standard surgical drains under bulb suction only, in     critically ill patients who require an open abdomen. Both techniques being used, the     commercial KCI AbThera™ device and home made Stampede VAC system, are currently approved     for use in Canada and used in our facility.      The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension     (IAH) and the abdominal compartment syndrome (ACS), the level of IAH must be treated and if     so how should be treated - remain controversial. The ultimate treatment for IAH/ACS is to     leave the abdominal fascia open after laparotomy, utilizing some form of temporary abdominal     closure (TAC) techniques, resulting in an open abdomen(OA). The decision to accept an OA     can only be made in the operating room and is typically made quite arbitrarily (there is no     current standard or protocol),and the TAC used is based on the surgeon's best judgment. The     study intends to randomize patients after it has been decided that a TAC is required, which     will be applied in the operating room while the patient is fully anesthetized. The only     intervention required is to obtain small aliquots (a teaspoonful-15ml) of blood for the     evaluation of inflammatory mediators levels, as well as the same volume of intra-peritoneal     fluid-that is typically discarded in patients with OA.   "
147385|NCT01355081|"     The purpose of this study is to assess the efficacy, safety and tolerability of 8-week     treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with     major depressive disorder.      The purpose of this study is to assess the efficacy, safety and tolerability of 8-week     treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive     disorder.   "
147386|NCT01355068|"     In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and     Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a     pivotal bioequivalence study.   "
147387|NCT01355055|"     Primary hypothesis:      Catheter-based renal denervation reduces central sympathetic activation in patients with     refractory hypertension.      Secondary hypotheses:        1. The magnitude of the individual depressor response after catheter-based renal          denervation depends on the extent of sympathoinhibition.        2. Both, the reduction in arterial pressure and in central sympathetic activation are          sustained over time up to 24±3 months after catheter-based renal denervation.        3. Catheter-based renal denervation resets the sympathetic baroreflex to lower blood          pressure values.   "
147388|NCT01355042|"     Severe sepsis (ie. life-threatening infections) is triggered by harmful microorganisms or     their toxins in the blood or tissues. These harmful agents damage the lining of blood vessels     which can lead to inflammation, blood clot formation, and vessel obstruction. In Canada,     there are approximately 90,000 patients with severe sepsis each year. Of these, 30% to 50%     will die. The identification of highly reliable outcome predictors in severe sepsis patients     is important for several reasons including: to help describe the severity of sepsis, to     classify patients for enrollment in clinical studies, and to monitor a patient's response to     treatment and procedures. In the investigators lab, the investigators examined the     incremental usefulness of adding multiple biomarkers to clinical scoring systems for     predicting ICU mortality in patients with severe sepsis. In a preliminary study of 80     patients with sepsis, the investigators found that high levels of plasma DNA predicted ICU     death better than any other clinical or biological factor. In this grant, the investigators     propose to confirm these findings in an external group of 400 patients in a blinded fashion.     The investigators also plan to study how plasma DNA levels change over time and whether high     plasma DNA levels can be used to distinguish sepsis from other critically ill conditions. For     this the investigators will compare the investigators septic patients to a cohort of 600     patients in the ICU with other conditions. The investigators believe this research has the     potential to significantly improve the management and treatment of septic patients.   "
147389|NCT01355029|"     The study will be evaluating to a 4 week education and support program for stroke caregivers.     The 4 week program will provide education, information, and strategies for dealing with areas     that caregivers may find challenging in their caregiving role. The study will evaluate the     effectiveness of the program to decrease the caregiver's stress, strain and burden, increase     the caregiver's knowledge of strategies and community services and increase their role     satisfaction as a stroke caregiver and quality of life two weeks after the program and 6     months after the program.   "
147390|NCT01355016|"     The purpose of this study is to determine the range of single inhaled doses of a new dry     powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects     on pulmonary function and determination of blood levels of MDT-637 following inhalation.   "
147391|NCT01355003|"     This study will collect safety information on the use of GARDASIL™ in the Philippines.   "
147392|NCT01354990|"     The primary objective of this study is to obtain safety information on the use of sitagliptin     (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.   "
147393|NCT01354977|"     The purpose of this research is to study the effects of a medication called resveratrol on     the body's response to insulin (a hormone to control blood sugar), on inflammation and/or on     specific cells and processes in fat tissue, and on skeletal muscle metabolism and on brain     function.   "
147394|NCT01354964|"     The purpose of this research is to study the effects of Vitamin D supplementation on the     body's response to insulin (a hormone that controls blood sugar), on inflammation and/or on     specific cells and processes in fat tissue, and on function of skeletal muscle and joints.   "
147395|NCT01354951|"     The purpose of this study is to see what side effects a type of radiation treatment called     focal brachytherapy has in treating early stage prostate cancer. The study is also looking at     how useful focal brachytherapy will be in treating prostate cancer. Additionally, the     investigators would like to see how this type of treatment impacts quality of life.   "
147396|NCT01354938|"     The objective of this study was to evaluate the role of Klaricid XL (clarithromycin modified     release) in the treatment of acute exacerbation of chronic bronchitis (AECB) and its impact     on improving the quality of life.   "
147436|NCT01354418|"     This study will assess the food-effect bioavailability of an extended release formulation of     phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl     product.   "
147398|NCT01354912|"     Nontuberculous mycobacteria (NTM) are ubiquitous organisms in the environment and are now     increasingly being recognized as significant causes of chronic pulmonary infection in     immunocompetent individuals (1). The most frequently encountered NTM lung disease worldwide     is caused by Mycobacterium avium-intracellular complex (MAC) (2-4).      In several studies with chest computed tomography (CT), researchers have demonstrated that     the presence of bilateral multifocal bronchiolitis (well-defined small nodules and branching     centrilobular nodules, or tree-in-bud pattern) and bronchiectasis distributed mainly in the     right middle lobe and lingular segment are indicative of NTM pulmonary infection (7-11).     Accordingly, it is believed that radiologic findings of bilateral bronchiolitis and     bronchiectasis on chest CT scans specifically suggest NTM pulmonary infection (1). These CT     findings, however, may not be specific for NTM pulmonary infection. CT patterns of     bronchiectasis and bronchiolitis in the pulmonary infections caused by various NTM organisms     have been reported, and these organisms include Mycobacterium kansasii, Mycobacterium xenopi,     and rapidly growing mycobacteria such as Mycobacterium abscessus, Mycobacterium fortuitum,     and Mycobacterium chelonae (12-14). In addition, not all patients with bronchiectasis and     bronchiolitis have NTM pulmonary infection. Two recent studies showed that only about 50% of     patients with such CT features have MAC pulmonary infection (9,15). To the best of our     knowledge, however, there is no report about the incidence of NTM in patients with     bronchiectasis or bronchiolitis in countries with low incidence of TB. Thus, the purpose of     our study was to determine the frequency of NTM pulmonary infection in patients with     bilateral bronchiectasis and bronchiolitis at chest CT and to investigate whether these CT     findings are specifically indicative of MAC infection or other specific pathogen.   "
147399|NCT01354899|"     The rational for the study is to add a thin self-adherent dressing on critically ill     patients. Evaluate if the dressing might protect the skin for further breakdown.Participants     will be followed for the duration of hospital stay, an expected average of 5 days.   "
147400|NCT01354886|"     The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a     single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed female     volunteers, in comparison with two marketed comparator products.   "
147401|NCT01354873|"     The investigators seek to compare the accuracy of the existing colonoscope model to determine     the magnitude of the improvement the investigators can expect in polyp discrimination as     neoplastic or non-neoplastic.   "
147402|NCT01354860|"     This study aims to assess the feasibility, effectiveness and safety of moxibustion for     symptom management and function improvement in patients with knee osteoarthritis, compared to     usual care group.   "
147403|NCT01354847|"     This study is planned to investigate the relationship between duration of extracorporeal     circulation and the extent of (acquired) platelet dysfunctions in patients undergoing cardiac     surgery.   "
147404|NCT01354834|"     The purpose of this study is to assess the effectiveness of Menopur to achieve clinical     pregnancy in females undergoing intrauterine insemination in clinical practice.   "
147405|NCT01354821|"     The aim of this study is to prospectively compare the perioperative mortality severe     morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and     3 thoracal abdominal aortic aneurysms.   "
147406|NCT01354808|"     The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance     to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major     adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients     with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary     intervention (PCI).   "
147407|NCT01354795|"     EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of     gastrointestinal track lesions and other organ lesions including mediastinal and     intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA     depends on several factors. For example, experience of the endosonographers, adequate     sampling, sample preparing, accurate interpretation by the cytopathologist and on-site     cytopathology interpretation. However, in many hospitals, no cytopathologist can be present     during EUS-FNA. Therefore, determining appropriate methods to obtain and prepare EUS-guided     FNA are important to make correct a diagnosis without on-site cytopathologist.      Suction with a self-retracting 10-mL syringe will likely bring in more cellularity but also     more blood. Some endosonographers use no suction, others use constant suction. Usually     specimen is expelled from a needle with pushing the stylet into the needle. But use of the     stylet during EUS-FNA is difficult and time consuming process. Injecting air was not     recommended, because of spraying out uncontrollably, increasing risk of air artifact and     specimen clotting. However, there is no further study which one is the appropriate, suction     or no suction and pushing the stylet or injecting air until now.      The hypothesis and aim of the prospective randomized controlled trials are as follows:      First hypothesis: There was no difference in the adequacy, cellularity, bloodiness,     contamination, air artifact in specimen obtained by each methods, suction or no suction and     pushing the stylet or injecting air.      Aim #1 : To compare the adequacy, cellularity, bloodiness, contamination, air artifact in     specimen obtained by each methods, suction or no suction and pushing the stylet or injecting     air.      Second hypothesis: There was no difference in sensitivity, specificity, diagnostic accuracy,     positive predictive value, negative predictive value and statistical agreement in specimen     obtained by each methods, suction or no suction and pushing the stylet or injecting air.      Aim #2 : To compare the sensitivity, specificity, diagnostic accuracy, positive predictive     value, negative predictive value and statistical agreement in specimen obtained by each     methods, suction or no suction and pushing the stylet or injecting air.   "
147408|NCT01354782|"     The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its     metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast     500 μg in healthy Chinese subjects.   "
147409|NCT01354769|"     Capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in     the expired respiratory gases; as such, it is a non-invasive monitoring technique which     allows fast and reliable insight into ventilation, circulation and metabolism. Capnography     has proven to be more effective than clinical judgement alone in the early detection of     adverse respiratory events. The shape of a capnogram is identical in all humans with healthy     lungs; any deviations in shape must be investigated to determine a physiological or a     pathological cause of the abnormality.      Data from a previous pilot study yielded two major findings:        1. Prediction of requirement for intubation, by the creation of an Integrated Pulmonary          Index (IPI) based on non-invasive physiological parameters        2. Breathing patterns during weaning in order to identify specific patterns used to predict          extubation success/failure      The intent of the current study is to gather sufficient data to either prove or disprove the     findings of the previous study   "
147412|NCT01354730|"     This was a retrospective cohort study of pregnant women who had received the AdimFlu-S     (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed     by chart review. If subject meets the eligibility criteria during the study period, data from     the medical chart were extracted retrospectively from the date of vaccination and the infant     (s) health status were followed until 8 weeks after the delivery.The unexposed cohort     included pregnant women who did not receive any influenza vaccine during pregnancy. Within     each participated study center, women who were gestation after April 2009 were randomly     selected according to maternal age matching. The pregnancy outcome, including the status of     delivery, abortion and gestational age, were extracted retrospectively by chart review.   "
147413|NCT01354717|"     This is a double-blind, randomized, placebo-controlled, three treatment parallel study in     which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the     face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals     (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be     counted at the baseline visit and at the visit four weeks following cessation of treatment.   "
147415|NCT01354691|"     For many, Alzheimer's disease is the number one medical issue facing our aging society. It is     a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and     cognitive performance. There are no known treatments that can either prevent or reverse its     progression. Consequently, there still remains a need to evaluate treatments which can better     stabilize the symptoms of this disease. These symptoms frequently include decreased     functional capacity and negative psychological attributes (e,g, depression, anxiety) in     association with the memory and cognition deficits. This current study is being done to     assess an investigational compound that has been designed to not only improved the cognitive     status of affected patients but to also better manage all symptoms. Hence, the ultimate goal     is to provide patients with an improved quality of life by slowing the progression of this     neurodegenerative disease   "
147416|NCT01354678|"     Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells     transplantation by intramyocardial multiple precision injection in ischemic heart failure     patients.   "
147417|NCT01354665|"     This study aims to evaluate the occurence and severity of fatigue and depression in multiple     sclerosis patients and the impact of Betaferon treatment on symptoms alterations.      The study is conducted in routine practice setting hence no interference with standard care     takes place.      Pharmacologic treatments of MS-fatigue and depression will also be recorded.   "
147418|NCT01354652|"     The purpose of this study is to investigate whether entecavir treatment increases the     incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase     inhibitors (NRTI), lamivudine, and/or no NRTI treatment, in patients with cirrhosis or     hepatic failure whose Model for End stage Liver Disease (MELD) scores are over 18.   "
147419|NCT01354639|"     The robotic thyroidectomy (RT) has excellent cosmetic and several functional results. But     there were no definite evidence of oncological safety of robotic thyroidectomy yet. To assure     the surgical completeness of robotic thyroidectomy, the investigators compared robotic     thyroidectomy and conventional open thyroidectomy (OT) by means of the postoperative     radioactive iodine (RAI) uptake of possible remnant thyroid tissue and stimulated TG level.   "
147420|NCT01354626|"     The objective of this study is to investigate the potential beneficial effect of increasing     protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.      The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid     accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced     lipid accumulation.   "
147421|NCT01354613|"     Heart failure with preserved ejection fraction (HFpEF) accounts for over 50% of heart failure     cases in the United States, affecting a primarily elderly population. No treatment has been     shown to affect mortality in HFpEF, which is more than 50% at five years a hospitalization.     This project explores the underlying cardiovascular physiology of patients with HFpEF with     the goal of identifying new therapeutic targets that would allow improved treatment of this     devastating disease.   "
147422|NCT01354600|"     The purpose of this research study is to examine the effects of overfeeding and exercise on     blood levels of hormones associated with regulating appetite, also thought of as feelings of     hunger and satiety (fullness). Previous studies have shown that non-obese people have     different amounts of these hormones in their blood compared to obese people.      The investigators hypothesize that exercise will promote improved insulin sensitivity and     corresponding beneficial changes in obese individuals. The investigators predict exercise     induced changes in 24-hour plasma hormone levels will be associated with improved appetite     during overfeeding in obese individuals.   "
147423|NCT01354587|"     The purpose of this study is to measure the changes in the Treatment Satisfaction     Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of     administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects     transitioning from subcutaneous Vivaglobin® to Hizentra®.   "
147424|NCT01354574|"     The purpose of this study is to determine if consumption of meals containing carbohydrates     with different glycemic index (a high glycemic index meal and a low glycemic index meal)have     different effects on energy expenditure, type of metabolic fuels used for energy, blood     lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to     satiety.   "
147437|NCT01354405|"     The aim of this study is to determine the effect of Lanreotide on polycystic liver and     kidneys in patients with autosomal dominant polycystic kidney disease.   "
147487|NCT01353755|"     To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail     of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with     rhinoconjunctivitis caused by grass pollen with/without controlled asthma.   "
148179|NCT01344694|"     Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty     liver, a condition carrying a high risk of cardiovascular disease. The independent role of     epicardial fat deposition in cardiovascular risk remains unclear.   "
147425|NCT01354561|"     The present study investigated the influence of respiratory affections on the heart rate     variability (HRV) of paediatric patients. We have hypothesised that respiratory physiotherapy     would promote a beneficial effect on the cardiac autonomic modulation. Twenty-four children,     who were divided into respiratory disease group (RG) and control (CG) groups, were studied.     Analysis of HRV was performed with the RG in the dorsal decubitus position during four     different moments: basal record (30 minutes); 5 minutes after respiratory physiotherapy by     means of airway clearance techniques (10-minute record); 5 minutes after nasotracheal suction     (10-minute record); and 40 minutes after nasotracheal suction (30-minute record). CG group     was submitted to the same protocol, except nasotracheal suction, which was not performed due     to ethical reasons.   "
147473|NCT01353937|"     Diabetic foot ulcers, a complication of diabetes leading to 80.000 lower limb amputations     annually in the US, are a significant burden to our health system, costing more than a     billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and     Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells)     from the bone marrow and traffic them toward the wound, increasing the blood supply that     subsequently improves wound healing. Because we are using the human body's own resources to     regenerate itself by targeting and correcting the underlying pathophysiology, we believe that     this novel therapy yields great promise in the treatment of diabetic foot ulcers.   "
147474|NCT01353924|"     The only disease-modifying treatment for allergic disorders nowadays is allergen-specific     immunotherapy (SIT). To induce hyporesponsiveness increasing doses of the disease-eliciting     allergens are applied. One major problem of this treatment is, that it has to combat with an     already established immune response against the disease-eliciting allergen. To circumvent     this problem the investigators want to perform the proof of principle study towards     prophylactic treatment. Prophylactic vaccination is used since many years for many infectious     diseases. The investigators want to adopt this successful principle for the treatment of type     I allergies.      For this purpose non-allergic healthy individuals will be immunized with adjuvant-bound     hypoallergenic derivatives of the major birch pollen allergen, Bet v 1. As usual for     allergen-specific immunotherapy, injections will be applied subcutaneously. Three injections     in one-monthly intervals will be given to establish the immune response and a further     injection after one year will determine how the vaccine-induced immune response can be     boosted.      The vaccine will be composed of an equimolar mixture of two adjuvant-bound hypoallergenic     derivatives of the major birch pollen allergen, Bet v 1. The first investigational product     (IP) designated as Bet v 1aF1 is a protein of 73 amino acid residues and represents the first     half (1-73aa) of the Bet v 1 molecule. The second IP, Bet v 1aF2, is a protein of 86 amino     acid residues and represents the second half (74-160aa) of Bet v 1. Both proteins are     expressed in Escherichia coli. The hypoallergenic derivatives lost their IgE binding     capacities by the disruption of the conformational IgE epitopes of the Bet v 1 molecule.      In several preclinical and clinical studies it has been shown that the two hypoallergenic     fragments, Bet v 1aF1 and Bet v 1aF2 have a strongly reduced allergenic reactivity and almost     no sensitization potential, requisite for a prophylactic treatment. In a multi-centre     placebo-controlled double blind clinical trial including 124 allergic patients no relevant     sensitization against new epitopes could be observed after vaccination of the Alum-bound Bet     v 1 derivatives.      In contrast, the vaccine induced a strong IgG response in animals as well as in clinical     studies. Vaccine-induced antibodies showed protective properties as they could inhibit the     binding of allergic patients' IgE. An improvement of clinical symptoms and a reduction of the     skin reactivity was correlated with an increase of IgG antibodies and could be shown only in     actively treated patients in a multi-centre placebo-controlled double blind clinical trial.      The investigational products will be tested in a Phase I clinical trial for prophylactic     allergy vaccination in healthy non-allergic subjects. The two IPs will be coupled either to     Alum and an equimolar mixture will be injected subcutaneously. The immune responses will be     compared to placebo. In total 20 non-allergic healthy male subjects (10 per group) will be     included in this clinical trial. For safety precautions the subjects will be monitored by     skin prick testing using the two uncoupled IPs and commercial birch pollen extract in short     intervals to recognize possible vaccine-induced sensitizations. The primary endpoint of phase     I clinical trial is the evolution of Bet v 1-specific and Bet v 1 fragment-specific IgG1-4,     IgE and IgM antibody levels in serum and in nasal fluids after vaccination of rBet v 1     derivatives.   "
147426|NCT01354548|"     Trismus (limited jaw mobility), can occur in patients undergoing radiotherapy to specific     areas of the head or neck. Trismus leads to difficulty in eating, swallowing, speech and     general mouth hygiene, which all have negative effects on quality of life. Research in the     area of trismus is limited; it is not known exactly when trismus develops, one study suggests     that some patients have experienced a diminished opening at as low doses as 15 Gy. Literature     suggests benefits of a training programme, but there is a lack of evidence to support the use     of a training programme during radiotherapy.      The purpose of this study is to investigate the effectiveness of a training programme during     and after radiotherapy, and report the incidence of trismus in patients who receive     radiotherapy to the jaw muscles. The study also investigates quality of life during     radiotherapy and up to one year after completed treatment.      Patients who meet the criteria and give their consensus to the study are divided into two     groups:      Group 1: Training with TheraBite Jaw Motion Rehabilitation System, which is a portable system     utilizing repetitive passive motion and stretching to restore mobility and flexibility of the     jaw musculature. Individuals train five times a day.      Group 2: Conventional treatment (jaw measurements once a week). If the individuals jaw     mobility decreases 15% from the original start measurement, the patient is automatically     offered a trainings program (as in group 1).      During radiation therapy a hospital specialist dentist measures the jaw mobility once a week,     thereafter at 3,6,12 months after completed Radiation Therapy. On 5 different occasions the     patients are requested to complete a Quality of life questionnaire. Patient's record their     training frequency in a log book.   "
147427|NCT01354535|"     The purpose of this study is to compare two different but standard treatments for the     fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction     internal fixation using a locked plating system versus plating and strut allograft with     cerclage wiring to determine which treatment results in a faster return to function as     measured by the TUG test at 6 weeks post-op.   "
147428|NCT01354522|"     Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative     breast cancer, while capecitabine is more effective in this group of patients.      This is a prospective, randomised phase III trial, to compare the efficacy and safety     profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive     breast cancer patients.      Control Arm: This includes 6 cycles of TAC 75/50/500 mg/m2 day 1 every 3 weeks. Experimental     Arm: This includes 6 cycles of TC 75/500 mg/m2, day 1 every 3 weeks, concurrently with     capecitabine 950 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest     period.      Women with hormone receptor positive tumours must receive 5 years endocrine after the end of     chemotherapy.      Patients may receive radiotherapy when clinically indicated.   "
147429|NCT01354509|"     Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)        1. Normothermia Protocol is successful in achieving and maintaining normal temperature in          moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs          from admission to Neuro ICU)        2. Normothermia is translated into improved neurologic Outcome and survival compared to          standard of care (Physician management)   "
147430|NCT01354496|"     The purposes of this study are to compare how much of LY2409021 enters the bloodstream and     how long the body takes to get rid of the drug when different formulations of LY2409021 are     given, and when LY2409021 is taken with or without food.      The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of     3 formulations of LY2409021. Subjects in each cohort will receive the same all 3 formulations     using a randomized sequence crossover design. There is a washout period of at least 14 days     between dosing periods.      There will be an interim analysis after Cohort 1 completes study period 2. Cohort 2 will not     begin enrolling until this analysis is complete. The need to enroll cohort 2 will be     determined by the outcome of the interim analysis.   "
147431|NCT01354483|"     The purpose of this study is to investigate the feasibility, safety, efficacy and optimal     dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal     cord injuries.   "
147432|NCT01354470|"     The proposed study will establish the safety and efficacy of modafinil in the treatment of     methamphetamine dependence, as well as assess the affects of modafinil on cognitive function     in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient     trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or     placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions.     This study will be conducted at the Addiction & Pharmacology Laboratory in San Francisco, CA,     and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.   "
147433|NCT01354457|"     The purpose of this study is to determine whether fractionated RIT with Epratuzumab and     radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.   "
147434|NCT01354444|"     This is a 6-month pilot randomized double-blind placebo-controlled trial of carvedilol, with     the primary objective being to determine whether carvedilol treatment is associated with     improvement in Alzheimer's Disease (AD) as compared to placebo treatment. Secondary     objectives are to monitor changes in cerebrospinal fluid amyloid levels and whether this dose     will be safe and well-tolerated in AD patients. Clinical assessments will be performed at     baseline, 3 months, and 6 months, while cerebrospinal fluid and blood samples will be     obtained at baseline and 6 months.   "
147435|NCT01354431|"     The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal     Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response     relationship exists.   "
147475|NCT01353911|"     This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir     (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin     (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.   "
147476|NCT01353898|"     This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and     pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants     will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice     per day) or placebo. Part II will begin after the results of Part I are known; participants     will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The     primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1     infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.   "
147438|NCT01354392|"     Diffuse large B-cell lymphoma is the commonest type of aggressive non-Hodgkin's lymphoma, a     type of cancer of a cell called a lymphocyte which makes up part of the immune system.     Although most patients are cured with chemotherapy used as initial treatment, about 20-30% of     patients still experience relapse. Curing relapsed disease is much less successful, even with     the use of high doses of chemotherapy and stem cell transplant. There is then an urgent need     for effective, new agents to treat patients with diffuse large B-cell lymphoma who have     relapsed or who have developed resistance to other forms of chemotherapy.      This trial is using a drug called AZD1152 which interferes with the ability of a cancer cell     to divide and grow. It has been used before in patients with other types of cancer, but never     before in lymphoma patients. Responses in other cancers have been seen, particularly in     leukaemia which is a disease related to lymphoma. The investigators are planning to use this     agent in 15 patients with diffuse large B-cell lymphoma in which potentially curative     treatments have failed. The main aim is to see whether the drug shows any activity in this     type of lymphoma. This will be mainly assessed using CT and PET scans. The investigators are     also investigating how well a blood test can predict both the response to the drug and the     toxicity of the drug - this is called a biomarker study and forms part of the clinical trial.     The other main aim of the study is to assess the toxicity of the treatment. Previous studies     in humans suggest the drug is reasonably well tolerated, although side effects such as     stomatitis (soreness of the mouth) and suppression of the bone marrow (leading to risk of     infection and bleeding) have been seen.   "
147439|NCT01354379|"     The purpose of this study is to test the safety and immune response of a new intranasal     vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that     is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a     vaccine work better), called W805EC. In a prior clinical study this vaccine showed promising     results in terms of being well tolerated and eliciting mucosal and systemic immune responses     after administration by a dropper. In this study NB-1008 is being administered by dropper as     well as a nasal sprayer to determine if the sprayer further enhances the immune response.   "
147440|NCT01354366|"     This clinical trial will evaluate two investigational hypoallergenic infant formulas with a     differing protein content to determine if they provide normal growth and are well tolerated     by term infants as compared to a marketed hypoallergenic formula.   "
147441|NCT01354353|"     This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and     tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated     therapeutic exposure under clinical investigation. In the event of poor tolerability in part     A of this study part B may be conducted to explore higher doses using titration. Subjects in     both parts A and B will participate in a 9 day wash-out period of current medication (Study     days 1-9); subjects coming into the study on aripiprazole will remain on their current     therapy throughout.   "
147442|NCT01354340|"     The principal objective of this study is to investigate the dose-effect of the Limicol food     supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.   "
147443|NCT01354327|"     The principal objective of this study is to investigate the effects of a novel food     supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate     hypercholesterolemia.   "
147444|NCT01354314|"     The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a     treatment for problems with memory, concentration, thinking, and judgment in people who are     infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major     depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal     infections.   "
147445|NCT01354301|"     Despite the improvement of efficacy results with current immunosuppressive regimens (about     15% of incidence of acute rejection), the security schemes used do not show the same     results.The most worldwide used regime is tacrolimus, mycophenolate and prednisone. Despite     the favorable efficacy results in our population, the use of this combination is associated     with higher incidence of viral infections such as cytomegalovirus, and gastrointestinal     events, two common causes of hospital readmissions after renal transplantation at our     institution.Given this, the investigators propose a study of our own initiative that attends     our local needs: identify the best strategy among the therapeutic options available to     maintain the result of current effectiveness and improve the safety profile for kidney     transplant recipients.This protocol is a prospective, randomized, single center, designed to     compare the safety and efficacy of three immunosuppressive regimens: (1) single dose of     antithymocyte globulin, reduced exposure to tacrolimus, everolimus starting on day 2 after     transplantation and prednisone; ( 2) basiliximab, reduced exposure to tacrolimus, everolimus     starting on day 2 after transplantation and prednisone; (3-control group) basiliximab,     reduced exposure to tacrolimus, mycophenolate and prednisone.Our hypothesis is that a single     dose of antithymocyte globulin or basiliximab induction therapy in combination with low doses     of tacrolimus, everolimus and prednisone results in comparable efficacy observed in patients     receiving tacrolimus / mycophenolate / prednisone, but with a better safety profile.      To ensure efficacy, the investigators added to the regimes the induction with monoclonal or     polyclonal antibody. To improve the toxicities associated with the current scheme, the     investigators replace the use of mycophenolate by everolimus and the investigators reduced     the dose of tacrolimus.      Patients will be monitored for blood levels of tacrolimus and everolimus to ensure adequate     exposure to immunosuppressive agents.   "
147446|NCT01354288|"     DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific     educational tool in order to assess its impact on glycemic control, quality of life,     knowledge about the disease and its daily management, over a period of 2 years. The     investigators plan to include 300 type 1 diabetic children in 10 french hospitals.   "
147447|NCT01354275|"     Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone     (GnRH) agonist and GnRH Antagonist fixed protocol.   "
147448|NCT01354262|"     This is a prospective, randomized, non-blinded interventional study that will investigate the     effect of a vitamin D supplement on HbA1c in patients with uncontrolled type 2 diabetes     mellitus (DM) and vitamin D deficiency. The goal is to investigate whether correcting vitamin     D deficiency will alter the HbA1c level in patients with type 2 DM and lower than normal     vitamin D level. My hypothesis is that correcting vitamin D deficiency decreases HbA1c levels     in patients with type 2 DM and vitamin D deficiency.   "
147449|NCT01354249|"     Prolonged fasting may increase the organic response to trauma. Carbohydrate-based drinks have     been tested and they may reduce insulin resistance. No study so far has aimed to examine the     possible benefits of whey protein drink in the composition of preoperative drinks.   "
147450|NCT01354236|"     This study aims to investigate psychosocial risk- and protective factors such as psychiatric     disorder, socio-economic background and family functioning among school dropouts and to     compare the findings with those by a matched control group of regularly enrolled students.   "
147451|NCT01354223|"     This study seeks to evaluate a new daily disposable contact lens compared to an existing     daily disposable contact lens.   "
147452|NCT01354210|"     The purpose of the proposed study is to test SMS (short message service) text messaging     technology to improve medication adherence among youth living with HIV (YLH). The proposed     study is a randomized controlled trial of the effect of text message reminders on ART     (anti-retroviral therapy) adherence among non-adherent YLH. Daily text message reminders will     be sent to patients randomized to the intervention group according to their medication     schedule, for 6 months. The investigators will enroll non-adherent YLH, ages 16-29. Half of     the sample, randomized to the intervention, will receive daily SMS text message medication     reminders and half will be randomized to the control condition and receive standard of care     (SOC) only. For the controlled trial, adherence levels and viral load will be collected at     baseline, 3-month and 6-month follow-up. In addition, at the end of the initial 6-month     enrollment period, participants in the control condition will cross-over to the SMS     intervention and participants in the intervention condition will cease to receive the SMS     intervention. Adherence and viral load data will be collected from each group at 9- and     12-month follow-up points. The investigators hypothesize that youth in the intervention     condition will demonstrate a clinically meaningful increase in adherence at 3 and 6 months     post-baseline, from approximately 70% to 90% adherence to ART.   "
147453|NCT01354197|"     The study observed the 28 days mortality of 9 participated University base surgical intensive     care unit (SICU) as well as the occurrence of adverse events in SICU.   "
147454|NCT01354184|"     This is an investigation of the efficacy and safety of CRD007 compared to placebo in the     treatment of patients with abdominal aortic aneurysm.   "
147455|NCT01354171|"     This is a multi-centre, prospective, randomized phase III trial to determine if     multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible     for active surveillance through better detection of clinically significant cancer.   "
147456|NCT01354158|"     The investigators seek to determine the efficacy, duration of action and safety of escalating     dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive hormones and     catecholamines during upright seated posture.      Primary Question:      1. What is the lowest dose of droxidopa that increases seated SBP to 115±5 mmHg in men and     105±5 mmHg in women?        -  When does the defined increase in SBP occur after oral ingestion of droxidopa?        -  How long does this dose of droxidopa sustain SBP at these levels?        -  What are the vital signs and the subjective symptomology following droxidopa          administration?      Secondary Question:      1. What is the MFV response to droxidopa administration in hypotensive individuals with SCI?        -  Does an increase in SBP correspond to an increase in MCA MFV?      Tertiary Question:      1. What is the vasoactive hormone and catecholamine response to droxidopa administration in     hypotensive individuals with SCI?        -  Does droxidopa administration result in a change in APR, Aldo or NE in hypotensive          individuals with SCI?   "
147457|NCT01354145|"     The main purpose of this study is to compare the cartilage volume loss at the Baseline visit     and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN)     1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.   "
147458|NCT01354132|"     The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early     phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and     Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur     during the pre-illness phase and around the transition to psychosis. Therefore, studying new     treatments that could target changes occurring during this period is of critical importance.      Aims:      Does add-on NAC treatment in early psychosis influence:        -  positive and negative symptoms        -  extrapyramidal side-effects of other medication        -  plasma concentration of glutathione        -  Mismatch Negativity, a physiological marker   "
147459|NCT01354119|"     Background: Aortic stent-graft is useful to occlude intimal tear and prevent further     dilatation of the false lumen in patients with aortic dissection. The long-term benefit of     aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well     demonstrated, especially in patients at high risk of aneurysmal change and death.      Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft     insertion performed just after the acute phase into the descending thoracic aorta in patients     with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.   "
147460|NCT01354106|"     The objective of this study is to determine the relative gentleness of two tapes recognized     for gentleness. A three-prong multidimensional evaluation consisting of laboratory     assessments, expert skin grader and subject discomfort assessment will be used.   "
147461|NCT01354093|"     Macular telangiectasia type 2 (MacTel Type 2) is an uncommon eye disorder that results in     slow vision loss beginning in middle age. The macula is the central part of the retina, which     lines the back of the eye like the film of a camera. The macula is responsible for central or     reading vision. Telangiectasis refers to dilated, leaky vessels, for example varicose veins     in the legs. One of the earliest manifestations of macular telangiectasia type 2 is an     acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal     center. Currently, the biochemical mechanisms and clinical significance underlying these     changes are not known, but it seems likely that better understanding of this phenomenon could     lead to new interventions against MacTel.      The objectives of this study are to image the maculas of MacTel subjects using two-wavelength     autofluorescence imaging and resonance Raman imaging to target the 7-degree radius pigment     ring characteristic of macular telangiectasia type 2 in order to gain further insight into     the significance of this early clinical sign, and to evaluate whether supplementation with     oral zeaxanthin can normalize macular pigment distribution in MacTel subjects   "
147462|NCT01354080|"     The purpose of this study is to compare the effectiveness of massage based on the tensegrity     rule and classical abdominal massage in persons with constipation.   "
147472|NCT01353950|"     The purpose of this study is to investigate the expression of a certain class of molecules,     called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic     disorder which renders the lung susceptible to persistent inflammation which, at times, can     worsen, resulting in accelerated decline in lung function and eventually death or transplant.     Our goal is to determine if the levels of costimulatory markers can be used to predict     exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.   "
147463|NCT01354067|"     The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients     resulting in increased dyspnea during physical activity restricts many COPD patients ability     to perform exercises in general and whole-body exercises in particular. Single limb training     performed as one-legged cycling has been shown effective in patients with COPD. This exercise     regime results in less stress on the ventilatory system as training is executed using a     simultaneously smaller muscle mass. However, the positive physiological effects of exercise     training only occur in the involved muscle(s). To be of benefit for patients daily life, all     relevant muscles should be included in exercise training. The aim of the current randomized     controlled multicenter trial (RCT) is to determine the effects of high-repetitive single limb     exercises (HRSLE) in combination with COPD specific patient education, compared to the COPD     specific patient education alone in patients with moderate to very severe (stage II-IV) COPD.   "
147464|NCT01354054|"     TENS is a non pharmacological intervention to control pain. Both high (>50 Hz) and low (<10     Hz) frequency TENS are used in the clinic and it is thought that each type works through     different mechanisms (see for review Sluka and Walsh, 2003). Hyperalgesia, an increased     response to a noxious stimuli, is one component of pain and occurs both at the site of     injury, primary hyperalgesia, and outside the site of injury, secondary hyperalgesia. Recent     studies in animals with arthritis of the knee show that low and high frequency TENS     differentially modulate primary and secondary hyperalgesia.      Therefore the investigators hypothesize that TENS will reduce hyperalgesia and pain with     movement resulting in increased function.   "
147465|NCT01354041|"     The primary objective of this pilot study is to examine the feasibility and acceptability of     a randomized, controlled study of a mindfulness and values-based living intervention targeted     at reducing fear of recurrence in breast cancer survivors compared to treatment as usual     control. Furthermore, the secondary objective of this randomized, controlled pilot study is     to determine preliminary efficacy and effect size of the mindfulness and values-based living     intervention compared to the treatment as usual control condition in reducing fear of     recurrence in breast cancer survivors.   "
147466|NCT01354028|"     Premature infants sometimes require sedation to ensure minimal movement during diagnostic     procedures such as MRIs. However, sedatives may produce adverse effects. The purpose of this     two-day study is to determine whether massage therapy will promote sleep in preterm infants     and also help them to stay asleep, providing a safer way to sedate infants for procedures. A     small instrument called a sleep watch or actigraph will be placed around the infant's ankle     to measure muscle activity and provide an indication of sleep. Infants will receive a 10-     minute massage on one morning of the study and no massage on the alternate morning.     Recordings from the actigraph will show whether there is difference in sleep pattern with and     without massage. Infants will be monitored for any heart rate and oxygen saturation changes     on both mornings of the study.   "
147467|NCT01354015|"     DRMS is a system that communicates with patients via text message using cellphones, computers     and other devices. It reminds patients about multiple health care and disease related issues     such as to test their blood sugars and send the result back to the system via text message.     The system will then decided based on automated algorithms whether to send another message     advising patients on changing their medication etc.      This pilot will enroll 100 injectible insulin dependent patients with uncomplicated Type 1     and Type 2 diabetes mellitus, using insulin, who will be enrolled to participate in the     pilot. Patients will be randomized 1:1 to either DRMS or standard care. The patients in the     DRMS program will undergo interactions with the system using multiple communications channels     including cell phones, IVR, email, web and SMS messaging. The goals of the interactive     programs are the following:        1. Monitor and intervene to remind patients to fill their prescriptions        2. Monitor and track insulin unit consumption utilization and timing of that dosage        3. Monitor and intervene when the patient does not use or take their medications as          prescribed.        4. Monitor and track insulin unit consumption and timing of that dosage        5. Ask the patient for their glucose levels and then provide customized information to the          patients regarding how to modify their medication to achieve the desired glucose level        6. Deliver automated dose adjustment directions based on the providers instructions        7. Coordinate personalized educational programs and messages into the automated          intervention programs        8. Provide feedback to the patients, including performance and reinforcement to both          providers and to patients.        9. Provide feedback to providers on patients performance as well as exception based          reporting      The System will manage interventions in an automated fashion. Providers will intervene on an     exception basis and only when automated interventions have not worked or the protocol     requires immediate action by the provider. For example, if the glucose exceeds certain danger     levels, as defined by the provider, a requirement might be to call and notify the doctor     immediately.   "
147468|NCT01354002|"     The aims of this protocol are: to collect and store diseased and normal tissue and body fluid     samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH),     affiliated sites and collaborating institutions; to collect and store samples from relatives     of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding     clinical and laboratory data on disease characterization, treatment, and outcome; and to     serve as a source of human biological samples and corresponding laboratory and clinical data.   "
147469|NCT01353989|"     A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A     IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people     above 40 years of age have a slower immune response to hepatitis A vaccination. However, a     lot of travelers seek pre-travel advice only shortly before their journey. More information     about the time to adequate antibody response after hepatitis A vaccination is required to     provide good protection during travelling. Alternative protection with immunoglobulins are     available.      Study design: Observational, longitudinal pilot study Study population: 20 adults over 60     years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis     A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as     controls.      Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent     is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28.      Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the     burden and risks associated with participation, benefit and group relatedness: hepatitis A     vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of     blood.   "
147470|NCT01353976|"     This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam     vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is     a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.   "
147471|NCT01353963|"     This is a non-interventional study to review safety data on administration of desvenlafaxine     succinate among Filipino patients with MDD and VMS per usual clinical practice within the     first three years post commercial distribution.   "
147520|NCT01353326|"     The purpose of this study is to compare the bone mineral density of patients who have     undergone either cemented or cementless hip resurfacing.   "
147477|NCT01353885|"     Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises     the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by     the breakdown of cartilage that lines the bones at your joints from daily wear and tear and     results in pain and restricted function. Total hip arthroplasty (THA) or total hip     replacement, is currently one of the most successful and cost-effective treatments used to     eliminate pain and restore function in those suffering from osteoarthritis. There are     multiple ways to perform a THA. The main difference between each type is the point of     incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The     incision performed can be anterior (in front of the muscle), anterolateral (in front and to     the side of the muscle), or posterior (from the back). Each of these approaches has its own     advantages and disadvantages, but there is no evidence available that makes one better than     the other. The purpose of this study is to determine which of the three approaches to THA is     the most effective. The main outcome that will determine the most effective approach is the     functional ability of the patients included in this study at 52 weeks. The investigators will     also compare whether the patient's: length of hospital stay, use of assistive devices, need     for revision surgery, ability to return to work, ability to relieve pain, complication rate,     and quality of life. The investigators hypothesize that the anterior approach will be the     most effective approach in reducing the rate of post-operative complications after THA.   "
147478|NCT01353872|"     The main objective of this study is to investigate the effects of ingestion of different     sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis     tournament simulation.   "
147479|NCT01353859|"     This multicenter, open-label, single arm study will assess the safety and efficacy of     RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active     rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying     antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously     every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly.     Anticipated time on study treatment is 24 weeks.   "
147480|NCT01353846|"     The purpose of this study is to compare the natural cycle (without any medication) with the     well-established artificial cycle in an egg donation program.   "
147481|NCT01353833|"     IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to     control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The     investigators recently showed that low dose IL-2 is well tolerated in patients with an     autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D     patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg     induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg     induction, the investigators aim to protect the remaining/regenerating β-cells from     autoimmune destruction, thus improving or even curing T1D.   "
147482|NCT01353820|"     The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis     (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol     concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus     control product.   "
147483|NCT01353807|"     The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of     long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant     women, while they were in gestational week 30, were randomized to fish oil supplements     providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no     supplements; they were asked to take the supplements until delivery. Health outcomes were     assessed during pregnancy and delivery. Further, offspring health and development has been     examined during the ensuring two decades by making linkages to the rich Danish health and     administrative registries, by asking the offspring to complete web-based questionnaires, and     by examining the offspring physically.   "
147484|NCT01353794|"     The objective of this Non-Interventional study is to evaluate the effectiveness & safety of     Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions     based on age of the patient (older (age >70 years) and younger patients (age <70 years).     Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of     cycles) and incidence of Hand foot Skin Reaction.   "
147485|NCT01353781|"     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and     preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing     schedules in Japanese patients with advanced solid malignancies.   "
147575|NCT01352611|"     The purpose of this study is to determine if intrathecal administration of baclofen can     reduce symptoms of severe tactile defensiveness and autism spectrum disorder.   "
147576|NCT01352598|"     This study will evaluate the local control rate as well as acute and late toxicity rates of     stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.   "
147488|NCT01353742|"     This is a phase I study being conducted to support the clinical development program of a FDC     product of the nucleoside analogue lamivudine and the nucleotide analogue adefovir dipivoxil.     To establish bioequivalence, the exposure of lamivudine and adefovir dipivoxil when     administered as the FDC will be compared to that of Heptodin (lamivudine) and Hepsera     (adefovir dipivoxil) when administered separately. In this study, the FDC product will     contain 100mg lamivudine/10mg adefovir dipivoxil.      Total 40 healthy adult subjects will be enrolled. The study will include a screening visit     and two treatment sessions. The screening visit will be conducted up to 3 weeks prior to the     first dose of Session 1. All subjects will receive Regimen A through B according to the     randomization schedule. Eligible subjects will be enrolled in the study and randomized to     receive the following treatment regimens in table below in one of the following treatment     sequences: AB, or BA. There will be a seven to ten days washout period between each treatment     session. Pharmacokinetic sampling for measurement of plasma lamivudine and adefovir dipivoxil     concentrations will be conducted over a 48-hour period following the morning administration     of study medication in each study session. During this time, all subjects will remain in the     unit for pharmacokinetic (PK) sample collection. The total duration (from screening to the     end of the study) of each subject's participation will be approximately four weeks.   "
147524|NCT01353274|"     Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in     patients with Hypertension   "
147489|NCT01353729|"     Approximately 40 healthy subjects will be enrolled. Each subject will participate in the     study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day     washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each     dosing period and will remain in the unit until Day 2. Each subject will receive a single     dose of each of the four treatments on Day 1 of each treatment period in a randomized     fashion. Subjects will be discharged from the clinical research unit after the completion of     all assessments on Day 2 of each period and return approximately 5-7 days later for the next     dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following     each treatment.   "
147490|NCT01353716|"     Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment of     human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of     Shionogi-ViiV Healthcare LLC. DTG is metabolized primarily by uridine diphosphate     glucuronyltransferase (UGT)1A1, with a minor role of cytochrome P450 (CYP)3A, and with renal     elimination of unchanged drug being extremely low (< 1% of the dose). Fifty-three percent of     the total oral dose is excreted unchanged in the feces but it is unknown if all or part of     this is due to unabsorbed drug or some percentage of biliary excretion of the glucuronide     conjugate which can be further degraded to form the parent compound in the gut lumen. The     current Food and Drug Administration (FDA) draft guidance for renal impairment studies states     that a pharmacokinetic (PK) study in patients with renal impairment should be conducted even     for those drugs primarily metabolized or secreted in bile, because renal impairment can     inhibit some pathways of hepatic and gut drug metabolism and transport.      This study is planned as an open label, single-dose, pharmacokinetic study to evaluate plasma     DTG pharmacokinetics following oral administration to subjects with severe renal impairment     (creatinine clearance < 30 ml/min) and matched healthy controls. Results from this study are     expected to enable the development of appropriate dosing recommendations in patients with     renal impairment.   "
147491|NCT01353703|"     This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when     administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks     or a 2-4-6 months schedule.   "
147492|NCT01353690|"     The aim of this clinical study is to investigate the safety and feasibility of Autologous     Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for     patients with advanced heart failure caused by ischemia.   "
147493|NCT01353677|"     This is a multi-institution, non-randomized, prospective pilot study to evaluate the     feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult     allogeneic Hematopoietic stem cell transplantation (HCT) recipients.   "
147494|NCT01353664|"     This study is intended to provide access to Romidepsin for participants who received     Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and     for participants whom the investigator feels may benefit from continuing treatment with     Romidepsin.   "
147495|NCT01353651|"     Even though the indication for endovascular therapy has been enlarged, open repair of common     femoral artery is still considered as the treatment of choice. A recent pilot study showed     that endovascular repair of the CFA seems to be a safe technique of revascularization with     acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in     press). TECCO, a French randomized and controlled trial, has been set up to compare open and     endovascular procedures for the treatment of CFA atherosclerotic lesions.   "
147496|NCT01353638|"     Peritoneal dialysis (PD) is a cost effective and safe form of renal replacement therapy in     patients suffering from end stage renal disease.      However currently available PDF (peritoneal dialysis fluids) are not biocompatible for the     peritoneal cavity and its cells. Acute cytotoxic effects of the majority of the current     glucose-based PDF are caused by low pH, lactate, high glucose and its degradation products     (GDP).      Toxic effects of PDF can thus be extended to suppression of mesothelial HSR (heat shock     reactions) following PDF exposure resulting in increased susceptibility of mesothelial cells     against PDF exposure: PDF inherent stress factors fail to adequately induce HSP as effectors     of the cellular stress response - the adequate HRS rather seems to be blocked.      Hence, therapeutic approaches to activate and enhance the HSR will reduce peritoneal damage     and organ failure and improve the survival of organisms.      Preclinical results demonstrated that supplementation of PDF with pharmacological doses of     alanyl-glutamine restored HSP expression and increased the resistance of mesothelial cells in     in-vitro models of PD and preserved peritoneal integrity in in-vivo models of PD.      After these positive preclinical results, this study shall now clarify, whether the addition     of alanyl-glutamine to the most commonly used glucose-based PDF is safe and tolerable.     Therefore PDFs will be drained in a randomized cross-over study. Main outcomes measures will     be total HSP expression in peritoneal cells and changes of the peritoneal transport kinetics     and the presence/absence/severity of side effects.   "
147577|NCT01352585|"     This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on     the treatment response to anagrelide hydrochloride   "
147497|NCT01353625|"     The main purpose of this first human study with CC-115 is to assess the safety and action of     a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with     advanced tumors unresponsive to standard therapies and to determine the appropriate dose and     tumor types for later-stage clinical trials. The bioavailability of tablet and capsule     formulations under fasting and fed conditions will also be evaluated in some patients.   "
147498|NCT01353612|"     This is a prospective, multi-center imaging study expecting to enroll approximately 1350     patients scheduled for clinically-indicated coronary angiography. Following informed consent,     patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and     non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up     period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography     as well as carotid ultrasound examination.      Additionally, patients will be contacted by phone on an annual basis for 5 years to collect     cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be     made using invasive and non invasive imaging tools in order to assess correlations between     vascular beds, imaging technologies and main cardiovascular events.   "
149183|NCT01331421|"     The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under     fasted conditions   "
147499|NCT01353599|"     Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due     to complete or partial loss of respiratory muscle innervation which is dependent upon the     level and completeness of injury [2]. In addition, they share many aspects of obstructive     airway physiology commonly associated with asthma. In asthma, physiological responses such as     decrease in baseline airway caliber, bronchodilatation following inhalation of a     beta-2-adrenergic agonist or anticholinergic agent, airway hyperreactivity, are all closely     related to airway inflammation. The cause of such inflammation is unclear, and may be     multi-factorial and attributable to: recurrent respiratory infections due to inability to     effectively clear secretions, unopposed parasymphathetic innervation, and loss of functional     sympathetic innervation to the airways. Therefore, the investigators propose to test for the     possible involvement the above mechanisms by pharmacological intervention, and to study     effects of such intervention on overall pulmonary function and indirect measures of pulmonary     inflammation: levels of FeNO, exhaled breath condensate (EBC) inflammatory biomarker profile,     pulmonary function tests, and cellular profile of the induced sputum.   "
147500|NCT01353586|"     The purpose of this study is to assess the safety and effectiveness of the Circular and     Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated     Pulmonary Vein Isolation System when used for the treatment of drug refractory symptomatic     paroxysmal atrial fibrillation (PAF).   "
147501|NCT01353573|"     Radiosurgery is precisely delivered high dose radiation. It can be performed using multiple     cobalt sources, a modified traditional gantry-based linear accelerator or a robotic linear     accelerator. The treatment of brain metastases represents the most common indication for     radiosurgery while new indications for this technology are continually being discovered. With     the increasing importance of radiosurgery and the resource implications for radiotherapy     programs the investigators have proposed the first direct technological comparison of robotic     to linear accelerator radiosurgery for brain metastases.   "
147502|NCT01353560|"     Despite widespread and growing popularity of complementary and alternative medicine (CAM) in     the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical     effectiveness, safety and cost- effectiveness. With previous funding support from NCCAM, the     Harvard Medical School (HMS) Osher Research Center established and trained a     multidisciplinary integrative team of CAM and conventional providers to work collaboratively     to provide state-of-the-art integrative care in a coordinated and individualized fashion.     The Osher Integrative Care Center (OCC) was opened in fall 2007, physically located within     the Ambulatory Care Center of the Brigham and Women's Hospital (BWH) at 850 Boylston Street     in Chestnut Hill, MA. The focus of this survey study is to characterize the decision-making     process of both patients and conventional providers with respect to communication about and     referral to an integrative care team in an academic hospital outpatient setting.   "
147503|NCT01353547|"     The purpose of the research study is to identify the genetic, environmental and immune     profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is     not a disease caused by a single variation in genetic material (DNA), a single environmental     factor, or a single malfunction in immune cells, there are genetic alterations, environmental     exposures and immunologic factors that make the development of MS more likely. Obtaining     information about who is at risk for MS will be beneficial in the future if the investigators     can identify effective ways to prevent or slow down the progression of this disease.   "
147504|NCT01353534|"     Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg     A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will     receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered     IM but followed by the topical application of a VEP at the vaccination site. Group 4 will     receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of     a VEP at the vaccination site.      The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)   "
147505|NCT01353521|"     Complex renal cysts are often incidentally detected on imaging. The differential diagnosis of     the complex renal cyst includes various benign cystic lesions, which are based on the Bosniak     classification scheme. Currently the standard of care in evaluating a complex renal cyst is     using a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic     resonance imaging (MRI) scan. Since both of these modalities present adverse events due to     frequent high doses of radiation, a technique such as a contrast-enhanced ultrasound (CEUS)     can be used to obtain the same results, without having to impose high doses of radiation upon     a patient.   "
147506|NCT01353508|"     Assess mechanism of action of LCZ696 related to sodium excretion.   "
147507|NCT01353495|"     Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM)     in 12 weeks.   "
147578|NCT01352572|"     The purpose of this study is to determine whether alteration of signal transduction     components after antidepressant targeting, predict antidepressant responsiveness in advance     before the appearance of the drug effects until 4~6 weeks after drug administration, or     represent the clinical status of depressed patients.   "
147508|NCT01353482|"     Mesothelioma is a relatively rare cancer which is becoming more common. It can affect one of     two areas; the pleura (the lining of the lung) or the peritoneum (the lining of the abdomen).     Cancer affecting the pleura is the more common of these and is called Pleural Mesothelioma.     This is most commonly caused by exposure to asbestos.      Unfortunately mesothelioma is usually diagnosed at an advanced stage and so treatment is     based around controlling the disease and managing the symptoms, rather than curing the     disease.      The standard treatment for Advanced Malignant Pleural Mesothelioma is a combination of two     anticancer drugs; Pemetrexed and Cisplatin.      The trial will look into whether there are benefits of adding a third drug called Vorinostat     to the treatment.   "
147509|NCT01353469|"     Primary Objective:      To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a     24-week treatment period in patients with type 2 diabetes mellitus.      Secondary Objectives:        -  To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2          diabetes mellitus on fasting plasma glucose (FPG)        -  To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients          with type 2 diabetes mellitus   "
149184|NCT01331408|"     The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume     restoration and shaping of the buttocks.   "
147510|NCT01353456|"     Recently, multimodal approach for postoperative pain control has been advocated.Combinations     of traditional and novel pharmacological agents are administered, aiming to improve     analgesia, spare opioid consumption, minimise adverse effects, and improve postoperative     bowel function in colorectal surgery.      One of the novel agents suggested is dexmedetomidine. It is a selective alpha-2 adrenoceptor     agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing     effects. Furthermore, a significant reduction in postoperative morphine consumption by using     patient-controlled analgesia (PCA) has been achieved when dexmedetomidine was administered     before operation. The drug also reduces cate-cholamine secretion, thereby reducing stress and     leading to a modest reduction in heart rate and blood pressure, which may be particularly     beneficial in patients with cardiovascular disease, while respiratory rate is not affected.      In this study, the investigators would like to evaluate the analgesic effects of     dexmedetomidine, which is administered intraoperatively with morphine, followed by     postoperative PCA morphine infusion, for postoperative pain for open and laparoscopic     colorectal surgery. Cyclooxy-genase-2 (COX-2) inhibitors and rescue intramuscular pethidine     will also be incorporated as part of the multimodal analgesia regimens.      Good pain control can help to decrease cardiovascular complications. Emerging data has     suggested a key role of soluble CD40L as inflammatory mediators of atherosclerotic lesion     progression. The investigators would like to evaluate the effect of our analgesic regimens on     soluble CD40L peri-operatively.      The investigators hypothesize that intraoperative dexmedetomidine can reduce postoperative     pain and improve recovery and outcomes.   "
147511|NCT01353443|"     AIDA Study is a prospective, multicentre, randomized, controlled clinical investigation with     patients undergoing median laparotomy for Abdominal Aortic Aneurysm (AAA) repair.      The primary objective of the clinical investigation is to test the hypothesis that insertion     of an Optilene® Mesh Elastic mesh - a monofilament, light-weight, large pore sized,     polypropylene mesh manufactured by Aesculap AG - is superior to suturing alone and will     reduce the hernia formation rate within the first 2 years.      A reduction from 30% to 10% of the patient population is assumed.   "
147512|NCT01353430|"     The investigators are researching families with inherited inclusion body myopathy (IBM)     and/or Paget disease of bone (PDB) and/or dementia (FTD) which is also called IBMPFD. IBMPFD     is caused by mutations in the VCP gene. Our main goal is to understand how changes in the VCP     gene cause the muscle, bone and cognitive problems associated with the disease.      The investigators are collecting biological specimen such as blood and urine samples, family     and medical histories, questionnaire data of patients with a personal or family history of     VCP associated disease. Participants do not need to have all symptoms listed above in order     to qualify. A select group of participants may be invited to travel to University of     California, Irvine for a two day program of local procedures such as an MRI and bone scan.      Samples are coded to maintain confidentiality. Travel is not necessary except for families     invited for additional testing.   "
147513|NCT01353417|"     This non-interventional study intends to collect epidemiological data in patients with stable     kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the     approved indication.   "
147514|NCT01353404|"     The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate     160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.   "
147515|NCT01353391|"     Insulin is the standard treatment for the management of type 2 diabetes in pregnancy, however     despite treatment with insulin, these women continue to face increased rates of adverse     maternal and fetal outcomes. The investigators hypothesize that metformin use, in addition to     treatment with insulin, will help with blood sugar control, lower the dose of insulin needed,     lower weight gain, and improve baby outcomes.   "
147516|NCT01353378|"     The purpose of this study is to determine whether dexmedetomidine is effective in the     treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.   "
147517|NCT01353365|"     Acute dyspnea and chest discomfort are common complaints. Distinguishing between the entities     that may present with such symptoms can be difficult. This project aims to study - venous     thromboembolism (VTE) - a difficult diagnosis that can easily be missed yet its treatment is     highly effective.      VTE represents a spectrum of disease ranging from deep vein thrombosis to pulmonary embolism     (PE). Early diagnosis of PE is usually based on suspicion raised by clinical symptoms     combined with a medical history of obvious predisposing factors. However, in around 30% of     cases PE occurs in the absence of any predisposing factors. Individual clinical signs and     symptoms are neither sensitive nor specific.      PE is generally associated with hypoxaemia, but up to 20% of patients with PE have a normal     arterial oxygen pressure .Classic ECG changes are generally associated with the more severe     forms of PE.      Bio-markers such as Plasma D-dimer (DD) have been investigated extensively in recent years.     It has been shown that a normal DD level renders acute PE or DVT unlikely; on the other hand     DD is not useful for confirming VTE.      CT angiography(CTA) has become the method of choice for imaging the pulmonary vasculature for     suspected PE. Yet as in DD the pre-test probability of PE based on the clinician's abilities     highly affects the results of the CT.      While VTE is a fairly common and sometimes lethal condition its diagnosis is difficult and     based more on clinical hunches than on highly sensitive and specific diagnostic tools. It's     quite evident that finding a novel, sensitive and even more importantly specific biomarker     for PE would change the current approach and work-up needed for reaching a diagnosis.      We propose using serum levels of surfactant associated protein (SAP) as such a bio-marker.     Surfactant is a unique phospholipoprotein secreted solely by type II alveolar cells in the     lungs. About 90% of the surfactant structure is composed of phospholipids and the remaining     10% is composed of specific proteins.      Working hypothesis and aims: PE causes ischemic damage to lung tissue. Such damage will     ultimately lead to a rise of serum SPA. The primary objective of this project is to ascertain     the fact that indeed there is a rise of serum SPA among patients diagnosed with PE, what is     the time-concentration profile of such rise and is the rise correlated to the size of the     embolus.      Methods: The study will be designed as a prospective study consisting of several steps. The     measurement of serum SPA will be done by commercially available ELISA kits. All patients will     be enrolled by researchers from both the ER and internal B ward at the Rambam Medical Center.      Probable implications to Medicine: If indeed SPA levels will be proven to be a novel     bio-marker for PE this could ultimately lead to a totally different approach in the     classification and treatment of patients presenting with signs that may be associated with     PE.   "
147518|NCT01353352|"     Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases     being seen annually in U.S. and Canadian EDs. While the majority of these cases represent     soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and     approximately 10,000 suffer spinal cord injury. There are no readily available national     Canadian data on ED visits such as those provided by the U.S. National Hospital Ambulatory     Medical Care Survey. The prevalence of potential neck injury can, however, be reasonably     estimated for Canadian EDs. Extrapolation, on a population basis, from reliable U.S. figures     suggests that 1.3 million potential neck injury patients are seen annually in Canada. Only     0.9% of these patients are found to have cervical spine fractures or dislocations.   "
147519|NCT01353339|"     Primary Research Questions:      Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be     assessed.        1. Under efficacy, this pilot will determine whether levofloxacin can decrease the          incidence of BK viruria and peak urine BK viral load.        2. Under safety, this pilot will determine the incidence of adverse events with          levofloxacin.        3. Under feasibility, this pilot will determine the number of kidney transplant patients          randomized over an eight month enrolment period, adherence to the levofloxacin and          frequency of patient drop-out and loss to follow-up   "
147521|NCT01353313|"     The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course     of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who     are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or     placebo. This study will determine if hydrocortisone improves infants'survival without     moderate or severe BPD and will be associated with improvement in survival without moderate     or severe neurodevelopmental impairment at 22 - 26 months corrected age.   "
147522|NCT01353300|"     RATIONALE: The identification of gene mutations in young patients with pleuropulmonary     blastoma syndrome may allow doctors to better understand the genetic processes involved in     the development of some types of cancer, and may also help doctors identify patients who are     at risk for cancer.      PURPOSE: This research study studies gene mutations in samples from young patients with     pleuropulmonary blastoma syndrome at risk for developing cancer.   "
147523|NCT01353287|"     The primary objective of this clinical trial is to evaluate safety of patients who underwent     Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission     as compared to those without procedure transmission.   "
147525|NCT01353261|"     This study is being done to learn more about platelet reactivity (how well the small cells in     the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for     stable and unstable (acute myocardial infarction) indications. Stable means you have not     demonstrated any acute injury to your heart prior to your PCI; unstable means you have     demonstrated some acute injury to your heart prior to your PCI. The investigators intend to     determine if there is a change in platelet reactivity from the time of PCI to 30days post-PCI     and does this change differ depending upon the conduction in which you present for PCI. This     is going to be done with a variety of platelet reactivity assays.   "
147526|NCT01353248|"     The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when     given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and     tolerable in the treatment of Chronic Genotype 1 HCV Infection.   "
147527|NCT01353235|"     Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on     therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care     unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded.      Randomization is stratified according to ventilatory support: non invasive or conventional     ventilation.The major outcome is the ICU mortality rate in overall population and stratified     according to ventilatory mode (noninvasive ventilation (NIV) versus conventional).      Secondary outcomes are superinfection necessitating a new antibiotic course, Length of     mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency of     gastric bleeding episodes that of frequency of hyperglycemic episodes.   "
147528|NCT01353222|"     This study was conducted to examine survival, disease-free survival, safety, and the     magnitude of the immune response induced following administration of DN24-02 in subjects with     HER2+ urothelial carcinoma.   "
147529|NCT01353209|"     The hypothesis in this study is that estrogen suppression by an aromatase inhibitor in     postmenopausal women with Lymphangioleiomyomatosis (LAM) will prevent or delay progression of     lung disease and result in a decrease in the rate of decline in FEV1   "
147530|NCT01353196|"     Carotid artery plaques are known to cause stroke. Cognitive impairment is an insidious but     poorly understood problem in patients with carotid plaques. Cognitive function describes how     people perform mental processes such as thinking, learning and problem solving. Asymptomatic     carotid plaques may affect 1 million Veterans who may be at risk for cognitive impairment. In     this study, the investigators will uncover the extent of cognitive impairment in Veterans     with carotid stenosis who are currently labeled asymptomatic. Programs to prevent or     mitigate cognitive impairment will depend on identifying the mechanisms by which this occurs.     The investigators will use sophisticated 3D imaging techniques developed by the group to     measure the structure and composition of plaques, number of particles breaking off from them,     blood levels of chemicals that could disrupt them, and blood flow restriction to the brain     from them. This will help identify patients at risk for cognitive impairment who may benefit     from preventative measures and improve selection of patients to decrease unnecessary surgical     procedures.   "
147531|NCT01353183|"     The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and     other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy)     based upon the detection of pathological alpha-synuclein species in routine colonoscopic     biopsies.   "
147532|NCT01353170|"     The study was designed in order to investigate the effects of 3 different dialysate calcium     concentrations may exert on mineral metabolism and hemodynamic stability in standard     hemodialysis (hd).   "
147533|NCT01353157|"     Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations,     associated with a systemic inflammatory response syndrome. The aim of this study is to assess     the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting     systemic inflammation. This correlation might identify peri-operative clinical outcomes, then     forecast further systemic inflammation in cardiac and hepatic surgical patients.   "
147534|NCT01353144|"     Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of     aspirin-related peptic ulcers.   "
147535|NCT01353131|"     Prevention of myocardial functional deterioration and sudden cardiac death among individuals     of intermediate risk remains one of the most elusive frontiers of contemporary medicine.     While most of these individuals are known to have had contact with the medical system, they     are frequently not considered to be at high risk until far advanced along one or multiple     disease processes leading to irreversible myocardial loss and electric instability. The goal     of this proposal is to determine the prognostic power of combining specific measures of     ventricular architecture, myocardial structure and electrical function for the early     identification of individuals at risk to develop ventricular arrhythmias and progressive     myocardial failure leading to severe cardiovascular outcomes and death.   "
147579|NCT01352559|"     The purpose of this study is to determine whether pharmacogenomic study of bioamine     transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant     responsiveness in advance before the appearance of the drug effects until 4~6 weeks after     drug administration.   "
147536|NCT01353118|"     Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations     can cause rapid and uncontrolled reductions in blood glucose. There is limited information on     whether:        -  metabolic surgery is superior to modern medical care for glycaemic control and type 2          diabetes remission.        -  metabolic surgery is safe for microvascular complications of Type 2 diabetes        -  good glycaemic control pre surgery has any effects on the long term glycaemia and          complications of type 2 diabetes.      This study aims to assess:        1. whether metabolic surgery is better for diabetes control compared to medical treatment.        2. whether metabolic surgery is safe for eye, nerve and kidney complications.        3. whether good sugar control before metabolic surgery improves the long term effects of          sugar control and microvascular complications.   "
147537|NCT01353105|"     Only about 15% of the potential candidates for lung donation are considered suitable for     transplantation. A new method for ex vivo lung perfusion (EVLP) has been developed and can be     used for evaluation and reconditioning of marginal and unacceptable lungs. The ´purpose of     this study is to analyse the executability and safety of ex vivo lung perfusion pulmonary ex     vivo in marginal donors.   "
147538|NCT01353092|"     In this study patients with treatment resistant depression, as defined by Harold Sackeim, is     subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment     (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are     randomized into two groups. In group A patients receive active treatment both morning and     afternoon. In group B patients receive one sham and one active treatment. The study is     double-blind as neither the assessors or patients are aware of treatment allocation. Each     session lasts 30 minutes. Patients are psychometrically assessed weekly for depression     severity and side effect. After this intervention period patients are followed for further     three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the     study period.   "
147539|NCT01353079|"     The primary objective of this study is to demonstrate that SLIT administered pre-and     co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short     ragweed pollen season.   "
147540|NCT01353066|"     Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for     cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV     risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial     intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at     the control of CVRF in T2DM may not translate in the reduction of CV events.      Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP)     could be superior in the control of the progression of subclinical atherosclerotic disease,     as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9     kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment     (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the     carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to     baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients   "
147541|NCT01353053|"     The aim of this the study is to the assess whether the graft and patient survival, rejection     rates and renal graft function after the first year will not differ between both study arms.     The investigators will also the evaluate the reduction in the incidence of cytomegalovirus     the and improvement of renal function of the everolimus after 1 year.   "
147542|NCT01353040|"     The purpose of this study is to characterize the safety and pharmacology of single     administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg     virus.   "
147543|NCT01353027|"     The purpose of this study is to characterize the safety and pharmacology of single     administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.   "
147544|NCT01353014|"     This study's primary objective is to determine if providing individuals with personal genetic     information impacts dietary intake behaviour. Specifically, the investigators will be     examining whether providing dietary advice based on genes that affect the metabolism of or     sensitivity to caffeine, vitamin C, sugar and sodium will impact the intake of these dietary     components. The study hypothesis is that providing dietary advice based on genetics will     impact dietary behaviour to a greater extent than general dietary recommendations.   "
147545|NCT01353001|"     The purpose of this study is to examine the effect of weight loss and exercise on     cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive     Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III     obese women during a 12 week training intervention.   "
147546|NCT01352988|"     The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters     (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of     responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI)     activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest     assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).   "
147547|NCT01352975|"     Background:        -  Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals          over 55 years of age. It can cause permanent loss of central vision, which is important          for seeing fine details and long distances. AMD has two forms: wet AMD and dry AMD. Most          people with AMD have dry AMD. But dry AMD can progress to wet AMD. Wet AMD is the more          serious form and can result in severe vision loss.        -  A method to identify and monitor the early to middle stages of AMD may help researchers          develop new treatments to stop the disease before it becomes severe. In early dry AMD,          people cannot see well at night. Researchers want to study whether a procedure that          measures how the eye adjusts to the dark can help to identify and monitor early to          middle dry AMD.      Objectives:      - To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor     early to middle dry age-related macular degeneration.      Eligibility:      - People at least 50 years of age who have no AMD. Others who have early to middle dry AMD in     at least one eye.      Design:        -  People will be screened with a physical examination, medical history, blood and urine          tests, and a full eye exam.        -  This study will last 5 years and require at least 9 visits to NIH. (First visit; study          visits at months 3, 6, 12, 18, and 24; and 3 yearly followup visits).        -  Up to 10 people will be asked to come back to the clinic 1 week after their first visit.          They will be asked to test the device to be used in the study.        -  Participants will have baseline exams. These questions will be about problems that          affect their eyes under different lighting conditions.        -  At every visit, participants will answer questions about general health and current          medications (including any vitamins or supplements). They will also have a full eye exam          and a 20- to 40-minute test. This test measures how fast the eyes recover in response to          decreasing levels of light. The test also measures how sensitive the eyes are to these          conditions.        -  Participants will continue to have these tests at the yearly followup examinations. They          will be treated with the standard of care for any eye conditions they have or may          develop during the study.   "
147548|NCT01352962|"     Background:      - Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer,     including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that     prevents the growth of new blood vessels in tumors, has been approved for treatment of     certain blood cancers, but it has not yet been approved for use in combination with     gemcitabine and carboplatin. Researchers are interested in determining the safest and most     effective dose of this combined form of chemotherapy for solid tumors, particularly for     urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis).      Objectives:        -  To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and          carboplatin as a treatment for solid tumor cancers.        -  To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and          carboplatin as a treatment for urothelial (bladder) cancer.      Eligibility:        -  Individuals at least 18 years of age who have been diagnosed with solid tumors that have          not responded to standard treatments.        -  Individuals at least 18 years of age who have been diagnosed with urothelial cancer that          has not responded to standard treatments.      Design:        -  Participants will be screened with a physical examination, medical history, blood tests,          and tumor imaging studies.        -  Participants with urothelial cancer will receive lenalidomide alone for the first 14          days of a 21-day cycle before starting the first full treatment cycle.        -  All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1          only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the          first 14 days of each cycle. Participants will be asked to take aspirin or other          medications to prevent the possibility of blood clots.        -  Participants may receive up to six cycles of treatment with this combination. If after          six cycles the cancer has not grown or has shrunk, participants may continue to take          lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until          the cancer recurs.        -  Participants will be monitored with blood samples, physical examinations, and tumor          imaging studies through the cycles of treatment.        -  After the end of the last treatment cycle, participants will have followup visits every          3 months for the next 18 months, then every 6 months for another 18 months, and then          yearly....   "
148795|NCT01336478|"     The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of     NK cells that will be selected from sibling donors and infused to patients with hematological     malignancies early following allogeneic stem cell transplantation.   "
147549|NCT01352949|"     Background:      - Stereophotogrammetry (SP) uses four sets of digital cameras to generate a three-dimensional     computer image. Unlike other types of evaluations which require radiation, SP only uses     computer images to learn more about physical deformities such as scoliosis or about the     placement of fat on the body. To refine the SP process, researchers are interested in     collecting images and body data from individuals with skeletal structural problems such as     scoliosis or chest wall deformities, individuals who are overweight or obese, and healthy     volunteers.      Objectives:      - To use stereophotogrammetry to study different individual body types and refine existing     imaging techniques.      Eligibility:      - Individuals at least 2 years of age who have spine, rib, or chest wall deformities; are     overweight or obese (body mass index greater than 25); or are healthy volunteers.      Design:        -  Participants will be screened with a physical examination and medical history. The          physical examination will include measurements of range of motion and joint mobility,          torso width and length, and other observational data.        -  Healthy volunteers and participants in the obesity group will also have bioelectric          spectroscopy (bioimpedance), which uses an additional machine to measure how fat is          spread in different parts of the body.        -  After the physical examination has been completed, participants will have SP photographs          taken. Participants will be asked to remove all clothing from the torso, stand with arms          raised at the center of four cameras, and remain still while several images are taken. A          complete image takes less than 1 second.        -  Participants with spine or rib deformities, or who are in the obesity group, may also          volunteer to return for followup SP imaging, once a year for 5 years, to study progress          over time.   "
147550|NCT01352936|"     Staphylococcus aureus, the most virulent of the many staphylococcal species, has been     recognized as one of the most important and lethal human bacterial pathogens. With the     increased incidence of methicillin-resistant staphylococcus aureus (MRSA) infection in     community and hospitalized patients, MRSA infections are associated with greater lengths of     stay, higher mortality, and increased costs. Vancomycin and teicoplanin, are the two most     commonly used glycopeptides and are the first-choice of treatment for MRSA infection.     Vancomycin-induced nephrotoxicity is still a point of controversy. Teicoplanin is not known     to have any nephrotoxicity. Acute kidney injury is a common complication of critical illness,     which is reported in 5 to 7% of hospitalized patients. It is associated with significantly     increased mortality, length of stay, and costs across a broad spectrum of conditions.   "
147551|NCT01352923|"     In this study PEAR1 polymorphisms effects will be analyze in blood platelets to determine how     PEAR1 regulates platelet activation.   "
147552|NCT01352910|"     Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy,     physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always     satisfactory with persistent symptoms after long-term follow-up. In a preliminary     retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ±     16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor cortex     at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9), with an     immediate or quasi-immediate recovery in 73% of patients (n=51).      We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to     the restoration of an appropriate cerebral connectivity by activating a suppressed motor     cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out.      A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be     done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis     at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be     performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz) with     an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the paralysis     at D2 (quantified by a videotape) and D60 (quantified by an interview and a standardized     examination), 2- the number and gravity of side effects.      If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be     considered a useful early therapeutic option.   "
147553|NCT01352897|"     The objective of this follow-up retrospective study is to evaluate the long term efficacy and     safety of rosuvastatin in reducing lipid parameters in clinical practice.   "
147554|NCT01352884|"     This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult     patients with cancer that is not responding to standard therapy. This study will be conducted     in two stages consisting of a Dose-Escalation stage and an Expansion Stage.   "
147555|NCT01352871|"     The innate immune response is the first line of defense against invading pathogens. Ideally,     the inflammatory response is tightly regulated leading to both adequate protection to     invading pathogens as well as limitation of an exuberant or unwanted immune response such as     seen in sepsis or auto-immune diseases. It has become increasingly clear that the autonomic     nervous system (ANS) and the innate immune response are intimately linked. Activation of the     sympathetic division of ANS dampens inflammation via β2-adrenoceptors. On the other hand, in     some cases, sympathetic drive can also stimulate the inflammatory response via     α2-adrenoceptors. The parasympathetic branch of the ANS modulates the inflammatory response     as well, since it was discovered that electrical stimulation of the efferent vagus nerve in     rats greatly inhibits the innate immune response. Generally, the ANS is regarded as pure     autonomic which can not be influenced by behavior. However, trough special     concentration/mediation techniques mastered by certain individuals, it might be possible to     modulate ANS activity. In addition, recent unpublished findings indicate that these     concentration/meditation techniques can also influence the inflammatory response ex vivo.      In this study the investigators wish to investigate the effect of concentration/meditation on     the innate immune response in vivo. In addition the investigators wish to elucidate the     mechanism via which this effect is mediated. The investigators aim to use the so called human     endotoxemia model. This model permits elucidation of key players in the immune response to a     gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential     novel therapeutic strategies in a standardized setting.      Objectives:      Primary objective: The primary objective of the study is to determine the effect of     concentration/meditation on the innate immune response induced by a lipopolysaccharide (LPS)     challenge.      Secondary Objective(s):        1. To determine the effects of concentration/meditation on ANS activity.          Electroencephalography (EEG), heart-rate variability (HRV), muscle sympathetic nerve          activity and plasma concentrations of catecholamines will be measured for this purpose.        2. To determine if concentration/meditation can attenuate (subclinical) renal damage known          to occur during human endotoxemia, markers of proximal and distal tubular damage will be          measured at various time points.   "
147565|NCT01352741|"     The main objective of the study is to evaluate the effectiveness, safety, and tolerability of     increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination     of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring     additional analgesia after titration to tapentadol PR 300 mg per day.      This is a clinical effectiveness trial designed to establish a link between anticipated     clinical outcomes and the clinical practice by means of selected measures of clinical and     subject reported outcomes. Since, severe low back pain with a neuropathic component, the     targeted study population, is frequently treated with a combination therapy (monotherapy is     often not effective enough) it is of interest to determine if tapentadol alone (combining 2     mechanisms of action in a single molecule) could be as effective as a combination of     tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus     combination are of interest.   "
147566|NCT01352728|"     The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving     transarterial chemoembolization is improved with addition of axitinib.   "
149185|NCT01331395|"     The purpose of this study is to determine the value of combining Traditional Chinese Medicine     (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).   "
147556|NCT01352858|"     This is a study which will look at safety, feasibility and acceptability of a new therapy     called tolerogenic dendritic cells (TolDC), derived from the patient's own white blood cells,     which will be injected into the knee joints of rheumatoid arthritis patients, using a     procedure called arthroscopy (a camera examination of a joint). The investigators are also     looking to see if the drug has any effect on the disease activity (if it can help in RA) and     whether the drug can affect the immune system. The investigators aim to treat 12 patients in     total, 9 with TolDC and 3 with a control treatment. Three doses of TolDC will be tested, 3     patients per dose. Subjects will have RA and at least one swollen knee joint. They will     undergo a knee ultrasound scan, fill in a series of questionnaires, have their knee aspirated     (fluid taken out) and finally undergo a procedure called leukapheresis (removal of white     blood cells) from which the treatment will be manufactured. Subsequently they will undergo 3     arthroscopies (camera examination of the knee joint) over a period of about 12 weeks. On the     first arthroscopy they will have the TolDC injected into their knee joint. They will then     spend the night at the Clinical Research facility for observation. Over the next 5 days they     will be telephoned daily by the study doctor to check how they are, and will be reassessed if     needed. About 2 weeks later they will have their second arthroscopy to look for effects of     treatment, and the third will take place at 13 weeks (end of study) or sooner if the knee     appears to get worse.   "
147557|NCT01352845|"     This study is looking at a new vaccine that might prevent meningococcal disease, and will     study the immune response elicited by this vaccine when given to healthy young adults. The     study will also look at the safety of the new vaccine as well as how it is tolerated.   "
147558|NCT01352832|"     The investigators propose a two-year group randomized trial of physician practices to test     the effectiveness of an interactive DVD that presents a culturally appropriate communication     training program for patients called How To Talk To Your Doctor (and Get Your Doctor to Talk     to YOU!) in promoting safe prescription and use of Nonsteroidal anti-inflammatory drugs     (NSAIDs) in the outpatient setting (HTTTYD-NSAIDs).      The outcome of interest is safer use of NSAIDs as reported by patients. The aims are to:      Aim 1. Develop an interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs)     that presents culturally appropriate stories through which a viewer can learn risk factors     for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs     with their doctor.      Aim 2. Conduct a group-randomized trial to test the following three hypotheses about the     effectiveness of the interactive DVD in promoting safer use of NSAIDs:      Hypothesis 1: Intervention group patients will be more likely to report that they had a     conversation with their doctor about safe NSAID use than control group patients.      Hypothesis 2: Intervention patients will report significantly fewer risky NSAID ingestion     behaviors (e.g., concomitant use of OTC and prescription NSAIDs) than control patients.      Hypothesis 3: There will be no difference in the intervention's effectiveness between African     American and White participants.   "
147559|NCT01352819|"     The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an     adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive     Parkinson's disease that are not adequately controlled with medication.      It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation     system using constant current instead of constant voltage and using a lead with an active     electrode tip.   "
147560|NCT01352806|"     The of epidurals and spinals, relies primarily on palpation of anatomic landmarks that are     not always easy to find, More so, even after correct identification of palpable landmarks,     Variability exists leading to performing neuraxial injection in undetermined intralaminar     level. The most accurate method for identifying the interspace is the using of the     fluoroscopy or CT technique, but exposure to radiation and availability make it unpractical     in majority of cases. As ultrasound technology becomes more accessible to the clinician, it     holds great potential to facilitate performing neuraxial anesthesia by the anesthesiologist     in routine cases.      The aim of this study to compare the accuracy of identifying the intervertebral space,     between manual palpation, versus ultrasound versus fluoroscopy.   "
147561|NCT01352793|"     A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to     receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will     receive HAVRIX vaccine at month 0 and 6 and saline at month 2.      All subjects will be followed for 6 months after the last vaccination to assess safety and     tolerability.   "
147562|NCT01352780|"     The aim of this study is to evaluate clinical and health economic parameters in relation to     individual motivational counseling by phone.   "
147563|NCT01352767|"     A randomised, controlled, cross-over study with inpatient and outpatient phases. The     inpatient phase length will be two days, which include a Control day without activating the     InSuPad and a Test day where the InsuPad is activated. The outpatient phase length is 8     weeks: 4 weeks without the device-Control, and 4 weeks with the device-Test.   "
147564|NCT01352754|"     Background: Patients undergoing hip fracture surgery are elderly and usually have     co-morbidities; hence they are at risk for perioperative MI. Troponin is the gold standard     for diagnosis of myocardial damage and currently the cornerstone of MI diagnosis.     Perioperative troponin elevation is a poor prognosis factor. The significance of minor     troponin elevation, detected by highly sensitivity troponin T assay, is unknown.      Objectives: To determine the frequency of perioperative troponin T elevation using highly     sensitivity troponin T assay, and to determine the clinical significance of this elevation.      Methods: Serum Troponin T levels of patients undergoing hip fracture surgery will be tested     prior to surgery 48 hrs and 72 hrs after surgery, using highly sensitivity troponin T assay.      Patients will be followed for 1 year. Primary outcomes- The number of patients with elevated     troponin levels perioperatively and cardiac mortality at 3 months, 6 months and 1 year.   "
147593|NCT01352377|"     Assessing the precise MIC for the Ceftriaxone using E-test. To determine what proportion of     susceptibility reports will be reclassified based on the new CLSI guidelines.Antibiotic     susceptibility reports of blood cultures, urine cultures,aseptic body fluid cultures growing     Enterobacteriaceae organism generated by the Phoenix machine will be obtained on a daily     basis.MIC for Ceftriaxone will be noted.If the MIC is <=2 for Ceftriaxone,those cultures     would be used to run an additional test - E- test.E-test gives us more precise MIC values     compared to Phoenix machine.We will analyze the data collected over 2 months. We will     determine the proportion of susceptibility reports reclassified based on the new CLSI     guidelines.   "
147567|NCT01352715|"     The study was conducted on people who were taking their first anti-HIV drug regimen     (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV     drug) but the drugs in this regimen were not doing a good job of fighting their HIV     infection.      The main purpose of this study was to compare two other anti-HIV drug regimens to see how     well they fight HIV. The study also looked at how well participants tolerate the drug     regimens and how safe they are.      The study was designed to determine whether taking the combination of lopinavir/ritonavir     (LPV/r) plus raltegravir (RAL) works as well as what is usually used for second-line therapy:     LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI)     combination. Testing a regimen that does not include any NRTIs was important because NRTIs     may no longer work for patients who received them as part of their first treatment regimen.   "
147568|NCT01352702|"     The aim of this study is to evaluate whether dabigatran reduces clopidogrel mediated ADP     induced platelet aggregation measured by MEA as compared to phenprocoumon after a two-week     treatment with either agent.   "
147569|NCT01352689|"     The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed     Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.   "
147570|NCT01352676|"     Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan     utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million     per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to     $13.8 billion with advanced imaging such as CT scanning largely responsible. CT represents     only 11% of radiologic examinations but is responsible for two-thirds of the ionizing     radiation associated with medical imaging in the U.S. Recent estimates suggest that there     will be 12.5 cancer deaths for every 10,000 CT scans. Renal colic is a common,     non-life-threatening condition for which CT is overused. As many as 12% of people will have a     kidney stone in their lifetime, and more than one million per year will present to the     emergency department (ED). CT is now a first line test for renal colic, and is very accurate.     However, 98% of kidney stones 5mm or smaller will pass spontaneously, and CT rarely alters     management. A decision rule is needed to determine which patients with suspected renal colic     require CT. While the signs and symptoms of renal colic have been shown to be predictable, no     rule has yet been rigorously derived or validated to guide CT imaging in renal colic. A     subset of patients with suspected renal colic may have a more serious diagnosis or a kidney     stone that will require intervention; however the investigators maintain that clinical     criteria, point of care ultrasound and plain radiography (when appropriate), will provide a     more comparatively effective and safer approach by appropriately limiting imaging.   "
147571|NCT01352663|"     This is an open label, randomized, parallel group comparison of the immunogenicity safety of     Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics     patients.   "
147572|NCT01352650|"     The hypothesis of this proposal is that combining plerixafor, an inhibitor of stromal cell     derived factor - 1α (SDF-1α), with decitabine, a DNA methyltransferase inhibitor, as     induction and postremission therapy for older patients with Acute Myeloid Leukemia (AML) will     improve treatment outcomes via mobilization of leukemia stem cells and alteration of the     pharmacodynamics of decitabine. The protocol will establish the safety and feasibility of     combining two different doses of plerixafor with a fixed dose and schedule of decitabine.   "
147573|NCT01352637|"     The purpose of this study is to test the differences between four active treatment conditions     for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality exposure therapy     (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or placebo, as well as to     examine predictors for PTSD and response to treatment in active duty military personnel,     veterans, and civilians who served in Iraq and Afghanistan.   "
147574|NCT01352624|"     Veterans with psychiatric disabilities face unique challenges concerning money management.     Financial strain, money mismanagement, and homelessness have been well documented among     veterans with psychiatric disabilities and linked to poor outcomes. The investigators'     long-term goal is to promote recovery among veterans with psychiatric disabilities by     addressing an 'unmet need' of developing basic money skills necessary for independent     functioning in living, working, and social environments. The investigators' objective in the     current application is to rigorously evaluate a pilot-tested, stakeholder-informed     intervention grounded in principles of psychiatric rehabilitation designed to help develop     money management skills and informed financial judgment among veterans with psychiatric     disabilities. $teps for Achieving Financial Empowerment ($AFE) is an individualized,     psycho-educational intervention that aims to teach veterans with psychiatric disabilities how     to save money, create a viable budget, avoid money scams and financial exploitation, and     access vocational and mental health resources. To evaluate the $AFE, the investigators will     randomly assign N=200 veterans with psychiatric disabilities to either (a) the $AFE     intervention (n=100); or (b) a usual care control (n=100). The investigators will interview     veterans with psychiatric disabilities at baseline and six months. The investigators' central     hypothesis, based on strong preliminary data, is that by fostering financial skills and     judgment, the $AFE will concurrently increase employment, boost work motivation, and reduce     disablement. If these outcomes are met, the investigators hypothesize the intervention will     also lead to reduced psychiatric symptoms and homelessness among veterans with psychiatric     disabilities.   "
147580|NCT01352546|"     The use of Botox injections intravaginally and progressive dilation under anesthesia has been     shown to cure vaginismus. This study expands the use of Botox injections to include     progressive dilation, post procedure supervised dilation and sex counseling to help women     transition from dilators to intercourse. Since 2005 patients continue to experience a cure     rate in excess of 90%. As of December 2012 more than 200 vaginismus patients have been     treated this way.      In this completed study of 30 patients with a minimum of one year follow-up 29 vaginismus     patients were able to advance to pain free intercourse (97%) and one patient failed to     achieve her goals presumably due to uncontrolled anxiety relating to vaginal penetration.   "
147669|NCT01351363|"     Following arthroscopic shoulder surgery a small but significant number of people suffer     severe postoperative pain.      This study aims to predict which patients are at risk of developing severe post operative     pain so that they may be targeted with a more aggressive post operative pain regimen.   "
147581|NCT01352533|"     The goal of this study is to assess whether wound closure with skin adhesive or running     stitches combined with skin adhesive will be superior to standard wound sutures. This is a     split-wound study that will compare two methods of skin closure within one standard closure     technique, thereby providing an internal control of running stitches within each wound. The     investigators plan to measure outcomes by assessing for scar appearance, the incidence of     wound opening, scar elasticity and subject satisfaction.   "
147582|NCT01352520|"     The goal of this clinical research study is to learn if SGN-35 (brentuximab vedotin) can help     to control ALCL, LyP or MF in patients with at least 1 of the 3 skin lymphomas. The safety of     the study drug will also be studied.   "
147583|NCT01352507|"     The primary objective of this study is to evaluate whether, after two 8-week treatment     periods, male patients with erectile dysfunction (ED) in China prefer 20 milligram (mg)     tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each     and an extension phase of 8 weeks, for a total of 24 weeks.   "
147584|NCT01352494|"     The purpose of this study is to assess the response of docetaxel and gemcitabine in the     neoadjuvant setting in women with locally advanced breast cancer.   "
147585|NCT01352481|"     -  The aim of the present study is to examine the effectiveness of a short, highly          structured parent based speech intervention program on speech development in very          preterm children with a Speech Sound Disorder (SSD) at 2 years of age.        -  The hypothesis of this study is that early intervention on speech development is          effective in improving the speech development in preterm children with SSD at 2 years of          age compared to a no treatment group (usual care at this age).   "
147586|NCT01352468|"     After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only     two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a     well-established evidence-base supporting their efficacy for children with ADHD. Both of     these interventions have inherent limitations. Recently multiple studies have demonstrated     that cognitive training may improve neuropsychological and behavioral functioning in children     with ADHD. The magnitude of treatment effects for cognitive training has been comparable to     treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes). A     limitation of existing cognitive training programs that may limit their efficacy is that each     has employed a unifaceted approach. Each intervention program has targeted a single cognitive     domain (e.g., working memory). This is problematic since as a group, children with ADHD have     multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition,     delay aversion, intra-individual variability) and thus a unifaceted intervention does not     address the multifaceted array of cognitive dysfunction in children with ADHD. Also, because     individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive     training approach may target areas which are non-deficient and miss areas of significant     deficit in individual patients depending on their ideographic cognitive profile. The primary     goal of the proposed research is to develop and test a multifaceted cognitive training     intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby     ensuring that children's unique areas of cognitive deficit are targeted. During Phase I (R21     grant), software and a manual will be developed consisting of four training tasks targeting     response inhibition, verbal working memory, attention, and delay aversion. Each task will     possess advancing levels of difficulty. On each task, children will receive feedback on     performance accuracy as well as on intra-individual variability in reaction times. The     software will be pilot tested in Phase I to determine performance thresholds and intervention     duration. Also, focus groups will be conducted to obtain patient perceptions of each task's     difficulty and interest level. In Phase II (R33 grant), a preliminary randomized clinical     trial will be conducted in order to obtain initial estimates of treatment efficacy. Pre-,     post-, and follow up outcomes will be collected on a wide range of neuropsychological,     behavioral, and academic measures. Effect size estimates across outcomes will be used to     guide sample size determinations for future clinical trials of multifaceted cognitive     training.   "
147587|NCT01352455|"     A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body.     Many children with permanent kidney failure undergo dialysis, a life saving procedure that     takes the place of a kidney. Currently, many children with permanent kidney failure only     receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on     dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than     their healthy counterparts. Survival for these children has not improved over the last 20     years. These data indicate that the current dialysis treatment strategy is unacceptable.      This research project will study if more frequent dialysis, performed 5 days per week, will     improve the health of children with permanent kidney failure compared to the current     treatment strategy. Children will be treated with both traditional and more frequent dialysis     schedules to measure improvements in their health and well being.   "
147588|NCT01352442|"     The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will     provide an effective method of for the correction of presbyopia in patients who have normal     distance vision but need correction such as glasses or contact lenses to see clearly at near.   "
147589|NCT01352429|"     This is a study to first establish feasibility of the study and then to register the     treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer     presenting for definitive radiation treatment with either proton radiotherapy or Intensity     Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated     strategy with our image guided treatment to further improve cancer control and decrease     toxicity.   "
147590|NCT01352416|"     The objective of this study is to show that ranolazine is a safe, viable and potent     alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac     surgery   "
147591|NCT01352403|"     The purpose of this study is to investigate the effects of gastric bypass in comparison to a     intensive life style intervention on cardiac function and quality of life in patients with     morbid obesity.   "
147592|NCT01352390|"     The goal of this project is to determine whether prompting the recipient of a health reminder     mailing to ask his or her 4-9 year-old child to color on the reminder could increase     engagement with the targeted health behavior   "
147719|NCT01350713|"     Skin burns are one of the causes of disability, suffering and death in humans. Anecdotal,     uncontrolled studies have shown the efficacy of povidone-iodine ointment in human skin burns,     provided the preparation was applied shortly after the exposure to the heat source. The     proposed study will conduct a controlled study in which the effect of povidone-iodine     ointment will be tested in large group of patients and will be compared with standard cold     water treatment.   "
147594|NCT01352364|"     This study aimed to assess and reassess the balance and motor skills of deaf children, passed     six weeks of intervention and to verify whether a program of physical therapy intervention     can match or improve motor skills. This study was quasi-experimental before and after, with     10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and     post test KTK Coordination Body, and the activities were held once a week for six weeks in     sessions of forty minutes. It was used for statistical analysis the Student t test dependent     and independent (p ≤ 0.05).   "
147595|NCT01352351|"     The University of North Carolina (UNC) and Partners for Development (PFD), an American     non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in     Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for     increasing the proportion of participants who exclusively breastfeed their infants until 6     months. The investigators will build upon PFD's existing microcredit and reproductive health     program by adding face-to-face breastfeeding education during borrowers' meetings and     bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will     remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention     group will increase by 15%. The investigators will measure the effectiveness of the     intervention by conducting baseline and final surveys with a cohort of 485 female borrowers     who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be     analyzed using logistic regression adjusting for possible confounders and the effect of     clustering.   "
147596|NCT01352338|"     Study Phase: phase 1 and phase 2      Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in     patients with relapsed multiple myeloma previously treated with lenalidomide      Study design: prospective, multicenter, non-randomized   "
147597|NCT01352325|"     The purpose of this study is to investigate the efficacy of system constellations in a     monocentric, single-masked randomized controlled trial.      The method of system constellations refers to an approach which integrates ideas from family     systems therapy with elements from psychodrama. The constellations are conducted in a group     based seminar-setting, each seminar lasting three days.      Based on the model of a general psychotherapy and the consistency theory, the effects of     system constellations on psychological functioning are explored.      It is predicted that participation in a system constellation seminar changes the level of     psychological functioning at 4 months.   "
147598|NCT01352312|"     This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab     (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell     Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal     dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how safe     these three drugs work together.   "
147599|NCT01352299|"     Orotracheal intubation the commonest method used to secure and maintain airway during     anaesthesia. A variety of methods are available for orotracheal intubation such as digital or     tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA (which is     becoming increasing popular, particularly in cased of anticipated difficult intubation),     fibreoptic endoscopic orotracheal intubation (also used when a difficulty is predicted), and     conventional and most common method, direct laryngoscopy. Orotracheal intubation is most     commonly achieved after visualization of laryngeal inlet with direct laryngoscopy following     induction of general anaesthesia and muscle relaxation achieved by administration of a muscle     relaxant.      Due to the hazards seen with failed intubation, anaesthetists are also on the lookout for     techniques which will improve visualization of the laryngeal inlet, i.e. glottis. View     obtained during laryngoscopy can be classified in a variety of ways such as Cormack Lehane     grading, the percentage of glottic opening (POGO Score)Literature suggests that straight     blade gives better glottic visualization while tracheal intubation is easier with the curved     blade. We therefore wanted to compare the Macintosh and Miller laryngoscope blades in terms     of visualization of Laryngeal inlet and ease of intubation in patients with normal predicted     intubation. We also compared the McCoy blade, a modified curved blade, and the Trueview     Laryngoscope, which incorporates a prism in a straight blade, for glottic view and ease of     intubation.   "
147600|NCT01352286|"     The purpose of this study is to 1) evaluate the safety and tolerability of autologous     genetically modified T cells transduced to express the high affinity NY-ESO-1c259 TCR in     HLA-A2+ subjects and 2) measure the incidence of GVHD in patients following infusion of TCR     modified autologous T cells.   "
147601|NCT01352273|"     This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two     stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and     tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part     to further assess the safety and preliminary anti-tumor efficacy of this oral combination     within two separate patient populations: i) patients with advanced solid tumors harboring     BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.   "
147602|NCT01352260|"     The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients     undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System,     Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to     determine which modality best correlates with jugular venous oxygen saturation   "
147603|NCT01352247|"     In the majority of patients with osteoarthritis of the knee the disease originates in the     medial compartment. There are two different approaches to replacing this arthritic area. Some     surgeons feel that it is always best to replace both the knee compartments with a Total Knee     Replacement (TKR). Others feel it is best to replace just the damaged component of the knee     with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee     surgeons. Both interventions are established and well documented procedures, yet little     evidence exists to support either practice. Each intervention is considered standard care.     There exists little evidence, however, to prove the clinical and cost effectiveness of either     management option.      The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the     clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee     Replacements in patients with medial osteoarthritis. This will be examined using an     appropriate patient base and long term assessments.      The trial has a combined device/expertise based allocation depending on the local situation.     Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR,     randomisation and allocation can be based on device (UKR or TKR). The same surgeon will     perform the operation for both arms of the study.      For surgeons who hold a preference for one treatment over the other, an expertise based     randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients     recruited to the study from these sites will be randomised to one of the treatment options     and treated by the appropriate surgeon. In such cases the patient is internally referred to     the other surgeon's operating list.      Patients will be recruited by their consultant knee surgeons in collaboration with the local     research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the     trial.   "
147668|NCT01351376|"     This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast     cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy     (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition     of LLLT to CDT will result in statistically significant improvements and greater long-term     benefits as measured by changes in arm volume and girth, pain levels, tissue texture,     symptoms experienced, and quality of life when compared to the benefits of CDT alone for the     treatment of breast cancer-related lymphedema.   "
147604|NCT01352234|"     Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth     retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic     use of aspirin on the recurrence of placental insufficiency and its complications, mainly     preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity     in medical practice in Canada and around the world in terms of the dose of aspirin used.      The objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is     associated with greater improvement in placental function assessed by biochemistry (sFlt-1     and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a     history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by     a test used in several Canadian centers (PFA-100).   "
147605|NCT01352221|"     The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation,     is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with     non-active Crohn's Disease (CD).   "
147606|NCT01352208|"     The study has three parts. Part 1 is a dose escalation to investigate the safety and     tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial     anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.   "
147607|NCT01352195|"     The primary purpose of this study is smoking cessation. The investigators are conducting a     research study to learn how well the information from the program helps participants to quit     smoking and remain smoke-free.   "
147608|NCT01352182|"     The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to     determine the effect on inflammatory biomarkers for pioglitazone in patients with severe     sepsis and septic shock.   "
147609|NCT01352143|"     The primary goal of this investigation is to determine the ability of recombinant activated     factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation     in neonatal plasma after CPB.   "
147610|NCT01352130|"     Postoperative nausea and vomiting [PONV] are common and distressing symptoms after surgery     performed under general anaesthesia. 5HT3 antagonists are routinely used for prevention as     well as treatment of PONV. After IRB approval we compared the effects of ondansetron and     granisetron on the various intervals on ECG in 70 patients undergoing elective surgery for     carcinoma breast after written informed consent. The demographic data was collected. The     administration of the anaesthetic was left to the discretion of the operating room staff     specialist. In the Postoperative Recovery Room patients were randomised to receive 8 mgs of     ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at 0 mins (before     injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours. Pulse rate,     Non-invasive blood pressure and SpO2 were also recorded. T   "
147611|NCT01352117|"     AIDS-related Kaposi's sarcoma (AIDS-KS) occurs in persons with HIV infection who are also     infected with the Kaposi's sarcoma herpesvirus (KSHV). Several chemotherapy (anti-cancer)     drugs work well in treating KS, but there is no treatment that cures KSHV infection. One     chemotherapy drug called etoposide (VePesid®, ET) has caused KS tumors to get smaller in some     people.      Antiretroviral therapy (anti-HIV drugs or ART) is a group of medicines taken together to     treat HIV infection. These medicines help to stop HIV from growing in the body. When this     happens, the immune system, which fights infection and some cancers like KS, gets stronger.     For some people, limited stage KS often improves or stays the same when they take ART.     However, in some people KS continues to get worse when taking ART. These people may need     chemotherapy at a later date.      This study was done to find out if taking ART with immediate etoposide (ET) is better than     taking ART alone or ART with delayed ET to treat limited stage KS. The study also tried to     better understand KSHV and to see what kind of side effects are caused by ART and ET and how     safe ART and ET are.   "
147612|NCT01352104|"     Investigating effectiveness of the cognitive-behavioral based teacher training under routine     care conditions by comparison of a baseline-interval with no special intervention to a     following interval of PEP for the kindergarten teachers only each focussing on one child (3-6     years old) that the teacher herself indicated as needing special attention for externalising     behaviour. Effects on child symptoms and teachers behavior and burden within     intervention-period are expected to be stronger than those during waiting-period.   "
147613|NCT01352091|"     The present study is a randomized open-label -phase III study that aims to compare the     efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and     Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years     for premenopausal breast cancer women with hormone receptor positive, lymph node positive or     tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as     endocrine responsive and endocrine response uncertain categories (table 3-1), and only those     with ER or PR expression undetectable were considered as HR negative. The pathological     evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary     nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or     directly through ALND when axillary nodes appeared to be positive in clinical examination.     Based on the operating standard of local medical institution, identifying the numbers of     lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station     nodes accurately.   "
147614|NCT01352078|"     The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health     records to study the reasons why some patients heal quickly and some have problems healing     wounds. All patients seen with an open wound or hidradenitis suppurativa are invited to     participate. Information from this research may help to understand how to prevent and treat     certain diseases.   "
147628|NCT01351896|"     This randomized phase II trial studies how well giving lenalidomide together with vaccine     therapy works in treating patients with early-stage asymptomatic chronic lymphocytic leukemia     or small lymphocytic lymphoma. Lenalidomide may stop the growth of cancer cells by blocking     blood flow to the cancer. It may also stimulate the immune system in different ways and stop     cancer cells from growing. Vaccines may help the body build an effective immune response to     kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger     immune response and kill more cancer cells.   "
147629|NCT01351883|"     Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines     and reduce postoperative infectious complications and length of hospital stay after major     upper gastrointestinal surgery.      (ANOM®)immunonutrition product name   "
147615|NCT01352065|"     Endothelin receptors antagonists (ERA), such as bosentan and ambrisentan, are a class of     vasoactive drugs that have been developed for the treatment of pulmonary arterial     hypertension. It has been anecdotally reported that ERA is frequently used among top-level     athletes to counteract exercise-induced rise in pulmonary vascular pressures and increase     exercise performance. Yet, the effects of ERA on exercise capacity in healthy humans are     puzzling, with the drugs not included in the current Prohibited List, since the ergogenic     potential is yet to be fully understood and determined. Furthermore, the urinary excretion of     ERA metabolites following administration has not been studied systematically at rest and     during exercise in athletes, as a way to detect its intake if performance-enhancing potential     is confirmed. In the planned study ERA will be administered in newly approved doses for 8     weeks in order to assess the presumed doping potential for both male and female athletes, and     to monitor serum and urinary ERA excretion dynamics after single- and multiple-dose     administration. The possible effects of prolonged ERA administration in higher doses on     exercise performance may be relevant, if further confirmed, in terms of their possible     fraudulent utilization to influence exercise performance in sports, raising the difficult     question of whether, particularly in some circumstances, the ERA might be considered as     prohibited substances in athletes.   "
147616|NCT01352052|"     The primary objective of the current study is to evaluate the outcome of an interdisciplinary     multi-component rehabilitation programme customized to patients with chronic widespread pain     (CWP) based on multidimensional diagnostic assessment including sub-grouping, and aiming to     improve functional ability in everyday life. The hypothesis is that a patient-focused     multi-disciplinary rehabilitation approach will improve both functional ability and quality     of life for patients with CWP.   "
147617|NCT01352039|"     The primary objective and endpoints of the study is compare the efficacy of two products     containing heparin sodium, evaluating if the formulation produced by Eurofarma can be     considered non-inferior to the reference product.   "
147618|NCT01352026|"     Treatment of PAH includes exercise limitation, non specific agents (anticoagulants, diuretics     and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents.      Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic     drug metformin, used in France since 1959 in diabetic type II patients, significantly acts at     the pulmonary arteries level.      According to these results, and knowing that metformin is a widely used drug, with a     favorable safety profile, the investigators decided to set up a pilot study, in order to     evaluate the activity of metformin in PAH treatment. In parallel, the investigators will     focus on metformin mechanism of action.   "
147619|NCT01352013|"     The purpose of this study is to find out if omega-3 fatty acid supplements are more effective     than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients     with fibromyalgia.   "
147620|NCT01352000|"     The study primary purpose is smoking relapse prevention. This study is a collaboration     between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt     Cancer Center in Tampa, Florida, and those associated with the New York State Smokers'     Quitline (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York.   "
147621|NCT01351987|"     To analyze the change in International Prostate Symptom Score (IPSS) and serum     prostate-specific antigen (PSA) level from baseline.   "
147622|NCT01351974|"     Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure     in breast cancer patients. However, ALND is accompanied by a considerable morbidity, and     sentinel lymph node biopsy (SLNB) evolved as a mean to decrease this morbidity. Between     September 2000 and January 2004 breast cancer patients were included in the Swedish Sentinel     Node Multicenter Cohort Study with the intent of studying axillary recurrence after negative     SLNB for patients in which completion ALND were omitted. The patients were followed     prospectively and events (local, regional and distant recurrences and deaths) were     registered. The primary endpoint was axillary recurrence and secondary endpoints were     disease-free, cancer-specific and overall survival.   "
147623|NCT01351961|"     In the cross sectional study Adelahyde 1 which took place between 2001 and 2005, the     investigators data suggest that vascular alterations may play a role in the setting of     subjective memory complaints.      This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the     evolution of cognitive function and dementia.   "
147624|NCT01351948|"     This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine     candidates administered alone and with adjuvants in various schedules. These vaccines consist     of inactivated viruses which have been modified, so they cannot reproduce in humans, and also     to include genetic material for malaria protein AMA1 which is expressed by the malaria     parasite during blood stage infection. The vaccines are designed to stimulate an immune     response to this malaria protein and thus provide protection against malaria infection.     Adjuvants are a crucial component of modern vaccine regimens, increasing the immunogenicity     and potency of protein vaccines. In this study we will assess whether virus vectored vaccines     combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909 adjuvant (emulsion     containing TLR agonist) can induce stronger and more durable immune response.   "
147625|NCT01351935|"     The purpose of this study is to evaluate the safety and tolerability of AVL-292 as     monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL),     chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).   "
147626|NCT01351922|"     This study is conducted in Asia. The aim of this observational study is to evaluate the     current status of diabetes management, control, and complications in diabetic subjects in     India. Perceptions and practices of physicians and subjects about diabetes management will     also be evaluated.   "
147627|NCT01351909|"     This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib     when given together in treating patients with breast cancer that has spread from where it     started to nearby tissue or lymph nodes or to other places in the body. Drugs used in     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor     cells, either by killing the cells, by stopping them from dividing, or by stopping them from     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes     needed for cell growth. Giving cyclophosphamide together with veliparib may work better in     treating breast cancer.   "
147632|NCT01351844|"     Patients have been asked to participate in the CEASE study because their treating oncologist     has recommended that they start an aromatase inhibitor medication. These medications are     associated with joint complaints. The purpose of this study is to see whether a     computer-based educational module is a feasible intervention to help address these symptoms.     If the patients agree to participate, a research coordinator will test their grip strength     and give them a computer log-on code. They will be shown how to log-on to complete the     educational module and a few simple questionnaires. Patients have the option to do this from     home if they wish. In 3 months time, the investigators will ask patients to return to the     clinic and have another grip strength evaluation and complete some additional questionnaires.     The computer module and the follow up visit will each take about 30 minutes of time.   "
147633|NCT01351831|"     Background and purpose:      In the early phase after a total knee replacement (TKA), patients experience a decrease in     leg muscle strength with up to about 80%. This considerable loss of muscle strength is     related to reduced functional performance at this point in time. As the loss of muscle     strength and functional performance is most pronounced early after TKA, rehabilitation     including strength training initiated early after TKA seems a logical choice. However,     tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain     and slow recovery of knee joint range of motion, have typically precluded strength training     early after TKA.      Hypothesis:      Our hypothesis is that the effect of early rehabilitation including strength training will be     greater than rehabilitation without strength training. If the hypothesis is confirmed,     strength training early after TKA could be implemented directly into clinical rehabilitation     practice.      Participants and methods:      Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand     and speak Danish, have given informed consent, will be included in this study.The study is a     single-blinded randomized controlled study, where the participants receive supervised 1)     rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components     of the rehabilitation program (balance-, and mobility training etc.) are the same in both     groups except the strength training exercises. Instead of the strength training exercises,     the group without strength training spend more time on warm-up exercises, mobility- and     balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed     twice per week. The participants perform a test battery 4 times from before to 6 months after     the TKA. The test battery assesses the participants' walking ability, leg strength, knee     pain, knee joint swelling- and range of motion, and self-reported function and quality of     life.      Ethical issues:      From a pilot study conducted in the beginning of 2010, the investigators found, that strength     training initiated early after TKA seems feasible, and does not increase knee joint swelling     and knee pain. None of the financial supporters, or any of the authors, have any potential     conflicts of interest with regard to the study.   "
147634|NCT01351818|"     To assess the influence of exogenous GH (growth hormone) administration on adipocyte     endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children     with delayed growth due to GH deficiency.      Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and     ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a     regulatory effect on such hormones.   "
147635|NCT01351805|"     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in     25,876 U.S. men and women investigating whether taking daily dietary supplements of vitamin     D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing     cancer, heart disease, and stroke in people who do not have a prior history of these     illnesses. This ancillary study is being conducted among VITAL participants and will examine     whether vitamin D or fish oil have effects upon A) autoimmune disease incidence, B)     biomarkers of systemic inflammation, and C) chronic knee pain. Blood samples at baseline and     in follow-up will be collected in a randomly selected subcohort of 2000 individuals and     analyzed for changes in biomarkers of systemic inflammation: C-reactive protein,     interleukin-6, and tumor necrosis factor-receptor 2. Approximately 2000 individuals with     chronic, frequent knee pain will be followed with annual questionnaires to evaluate the     effects of the supplements on chronic knee pain.   "
147636|NCT01351792|"     The purpose of the present study is to demonstrate the higher efficacy of small particles     Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations     b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic     Obstructive Pulmonary Disease (COPD) patients.   "
147637|NCT01351779|"     Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows     progressive damage with characteristic loss of visual field. Glaucoma is very commonly     associated with raised pressure in the eye (intraocular pressure [IOP]). IOP has been shown     to increase when lying down in normal subjects as well as patients with glaucoma. It is     possible that this effect can make glaucoma worse. This study is designed to investigate the     effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each     patient will be required to attend for 2 separate 24 hour visits. On one visit the patient     will be required to sleep flat and on the other visit at a 30° head up sleeping position.     During this time the patient will be required to wear a soft contact lens (SENSIMED     Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP     measurements are wirelessly transmitted to a recorder.   "
147638|NCT01351766|"     Evidence suggests a significant percentage of adolescent regular smokers are interested in     trying to quit smoking and frequently make attempts to quit, yet are unsuccessful in     maintaining abstinence on their own. Despite a genuine desire to quit on the part of many     adolescents, there is an increasing incidence of smoking among older adolescents that runs     counter to the overall trends of smoking reduction seen in the general population.     Unfortunately, psychosocial and pharmacological smoking interventions have yet to indicate     clear effectiveness with youth. Moreover, depression-related vulnerabilities, particularly     currently elevated depressive symptoms, are highly comorbid with smoking behavior and     dramatically reduce cessation rates. As a result, new approaches to smoking cessation are     needed for adolescent smokers with currently elevated depressive symptoms. Thus the objective     of the present study is to develop a specialized behavioral activation treatment for smoking     in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus     groups and pilot testing with 15 youths to develop the behavioral activation smoking     treatment for youth (BATSY). In Phase II, we will conduct an open-label trial of BATSY plus     nicotine replacement therapy with 30 youths who will also take part in a neuroimaging     protocol examining reward sensitivity. Participants will be followed over 26 weeks post-quit     date.   "
147649|NCT01351623|"     The purpose of this study is to test a new drug called carfilzomib. It is a type of drug     called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to     the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins     cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma cells     make a lot of protein and are especially in need of a functional proteasome to survive.      Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It     is considered an experimental drug. Previous studies have shown that carfilzomib is safe to     use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.   "
147639|NCT01351753|"     Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality,     but is difficult to treat. Partly this is due to the transient, arduous and modest nature of     lifestyle interventions. Partly it is due to the limited efficacy and safety problems of     existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity;     but its effects on weight are relatively small. There are drugs that have been approved for     other diseases but which also reduce weight. One promising approach to treating obesity is     combination therapy with orlistat and one or more of these other agents. The investigators     propose an innovative approach to developing new therapies for obesity coupling the use of     combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a     quantitative surrogate clinical endpoint that has been strongly and independently linked to     future cardiovascular events.      Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular     function in obese human subjects. The co-primary endpoints will be weight and vascular     function.   "
147640|NCT01351740|"     A drug-drug interaction between the anti-HIV drugs tenofovir DF (TDF) and atazanavir (ATZ)     results in lower ATZ plasma levels when the drugs are given together, particularly in     patients not taking ritonavir to boost ATZ levels. Lower plasma drug levels may make the     anti-HIV regimen less effective in controlling the HIV virus levels in the blood. For this     reason, current treatment guidelines recommend that ATZ always be boosted with ritonavir in     regimens also containing TDF. However, withdrawal of ritonavir is often desirable given the     tolerability and toxicity issues with this agent, even at the low dose (100 mg daily) used to     boost ATZ. For example, ritonavir can cause stomach upset, nausea, diarrhea, high cholesterol     levels, and liver enzyme abnormalities.      However, there is evidence that plasma ATZ levels may not predict treatment success on     unboosted ATZ regimens, particularly among people whose plasma HIV virus is already under     control and unboosted ATZ is being used as a maintenance strategy. In the BC Centre for     Excellence in HIV/AIDS Drug Treatment Program (DTP), nearly 100 patients originally treated     with ritonavir-boosted ATZ + TDF (+ FTC or 3TC) are receiving successful maintenance therapy     with unboosted ATZ and the same TDF-based backbone.      The study will examine the hypothesis that switching to maintenance therapy with unboosted     ATZ 400mg daily will have similar 48-week virologic efficacy to continuing ATZ/ritonavir     300/100mg daily among HIV-infected adults with stable viral load suppression on regimens     comprising ATZ/ritonavir 300/100mg daily with TDF plus either FTC or 3TC, despite potentially     lower ATZ trough levels with the unboosted regimen. In other words, patients whose HIV viral     load is undetectable while receiving TDF (+FTC or 3TC) and ATZ/ritonavir will continue to     maintain an undetectable viral load after switching to unboosted ATZ without ritonavir, in     the same proportions as those continuing on their boosted ATZ/ritonavir regimen.   "
147641|NCT01351727|"     The purpose of this proposed research is to identify individuals in southeastern Arizona aged     65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them     for at least two years. In doing so the investigators will be able to describe the public     health burden of this condition and to identify factors that predict clinical outcomes and     health care needs in this population, using quantitative, administrative, and qualitative     data. The aims of this proposed research are 1) to determine the two-year incidence of newly     diagnosed epilepsy in the target population, 2) describe health care resource utilization of     the target population using Medicare data, 3) validate the use of Medicare beneficiary data     to estimate incidence of epilepsy, and 4) describe the burden of this condition in different     ethnic groups.   "
147642|NCT01351714|"     When performing a resection of the right colon due to cancer one aims not only to remove the     tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph     nodes are located along the arteries supplying the right colon. Through using a preoperative     CT scan which can map these arteries very precisely one can ligate these vessels closer to     their origin and thus remove more lymph nodes which may potentially harbor cancer cells. This     study aims to compare patients operated more radically through use of preoperative CT which     maps the mentioned arteries with patients operated in the standard way.   "
147643|NCT01351701|"     The pattern of organism causing diabetic foot infection are presumed to vary from location to     location depending on the antibiotic prescription practice, geographical locations,     environmental variations and therapeutic interventions for various patients. Our hypothesis     is look to finding out common similarities with diversified subgroups spread across various     geographical locations of eastern part of India, thus to create a data base for treating     patient with diabetic foot infections.The sensitivity pattern is anticipated to be different     from institution to institutions and place to place but the gross sensitivity data of local     pathogen could guide physician for choosing right empirical antibiotic. Practice guideline     could be postulated from the collated data of distribution of pathogens, their sensitivity     pattern as well as co-morbid conditions of the sufferers.   "
147644|NCT01351688|"     The primary aim of study is to gain an initial assessment of safety and tolerability of     AZD3514 in Japanese patients together with assessing Pharmacokinetics (PK) and gaining a     preliminary assessment of anti-tumour action. In this study, AZD3514 will be administered to     Japanese patients with metastatic castration resistant prostate cancer.   "
147645|NCT01351675|"     This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying     progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with     Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.   "
147646|NCT01351662|"     Linking a psychosocial stress intervention with clinical measures of stress in African     American lupus patients will assess the utility of this method in reducing perceived stress,     and provide the necessary preliminary steps toward future investigations of potential     mechanisms.   "
147647|NCT01351649|"     Specific aims are:        1. Evaluate the feasibility of the intervention related to (1) girls' participation; (2)          adherence to protocols; and (3) user and provider (nurse and PA Club instructors)          satisfaction.        2. Explore if participants in the intervention group, compared to those in the control          group, show improvement in the primary outcome of minutes of moderate to vigorous          physical activity (MVPA; measured by accelerometer), and also secondary outcomes of          self-report of MVPA, cardiovascular fitness, body mass index, percent body fat, and          waist circumference at 6 months.        3. Explore if the primary outcome is mediated by cognitive (perceived benefits of PA,          perceived barriers to PA,PA self-efficacy, social support, norms, models) and affective          (enjoyment of PA) variables.        4. Explore if participants in the intervention group, compared to those in the control          group, have greater minutes of MVPA at 7 months.   "
147648|NCT01351636|"     The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality     and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.   "
147650|NCT01351610|"     MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow     derived stem cells for the treatment of Critical Limb Ischemia   "
147654|NCT01351558|"     There is ample evidence that exercise therapy is beneficial with respect to pain in patients     with osteoarthritis of the knee. However, the pain relieving mechanisms are unknown. To     enhance the efficacy of exercise therapy a deeper understanding of the involved mechanisms is     needed.      Different exercise types may affect the pain sensitivity differently. It is hypothesized that     non-specific exercises (i.e. exercises that does not involve the knee) reduces the processing     of pain in the central nervous system (central sensitivity) to knee joint pain in healthy     subjects. It is also hypothesized that exercises that involve the knee (i.e. specific knee     exercises) reduce the sensitivity of pain receptors in the knee (peripheral sensitivity) in     healthy subjects.      Healthy volunteers are recruited and randomised to one of four interventions: 1: Muscle     strengthening exercises involving the thigh muscles; 2: Muscle strengthening exercises     involving the shoulder muscles; 3: Cardio-vascular fitness exercises; or 4: Control (no     exercises). The active interventions include exercises three times per week for 12 weeks.     Pain sensitivity and a range of explanatory variables is measured before the interventions,     after 4 weeks and after 12 weeks.   "
147655|NCT01351545|"     This study is an access and distribution protocol for unlicensed cryopreserved cord blood     units (CBUs) in pediatric and adult patients with hematologic malignancies and other     indications.   "
147656|NCT01351532|"     The purpose of this research is to apply this smoking cessation program on oral cancer     patients, and to analyze the effectiveness of it.   "
147657|NCT01351519|"     In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA)     prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor     tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light     in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink     allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The     aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue     improves the surgeon's ability to completely resect or remove the brain tumor.   "
147658|NCT01351506|"     Aims of study        1. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in          28 days        2. Determination cut point of maximum weight change to outcome treatment   "
147659|NCT01351493|"     The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore     recovery.   "
147660|NCT01351480|"     The purpose of this study is to determine if the use of sub-cutaneous (SC) abatacept provides     any structural benefit in patients with rheumatoid arthritis who have failed prior use of TNF     therapy.   "
147661|NCT01351467|"     The purpose of this study is to examine how genes and environment affect risk for Parkinson's     disease.   "
147662|NCT01351454|"     The objective of the current study is to test a novel, behavioral approach to treat     depressive symptoms and improve HIV medication adherence and subsequent physical health     outcomes among African American HIV-infected substance users residing in inner-city     Washington, DC. This treatment will serve as a compliment to standard residential and     follow-up outpatient substance use treatment, with the goal of reducing depressive symptoms     and improving HIV medication adherence, physical health, and substance use outcomes.   "
147663|NCT01351441|"     It has been shown that patients can improve their safety through informed choice, safe     medication use, and complication reporting. This includes not only the potential problems     that occur from prescription medication use but also issues that may arise through the     improper use of over-the-counter medications. The willingness of a patient to take on safety     action is known to be complicated by an unwillingness to behave in a manner that might     challenge a physician's judgment or actions. Community pharmacists are in the unique position     to provide perspective on the physician's recommendation and act as an advocate to facilitate     necessary change. Through supportive and repeated interaction with their community pharmacist     patients will develop assertiveness toward their own health care, an increased frequency and     quality of interaction with their physician, and thus a minimized risk of harm and maximized     opportunity to optimize clinical outcomes.   "
147664|NCT01351428|"     Preeclampsia is associated with significant maternal and fetal morbidity and mortality. Early     identification and subsequent management of patients at risk of developing preeclampsia     presents an ongoing challenge in prenatal care. Some at risk pregnancies may be identified     from:        -  serum screening abnormalities in the first or second trimester        -  placental shape and texture at the 18-20 anatomical ultrasound        -  uterine artery blood flow.      Early identification and effective treatment of patients would permit the safe completion of     the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular     monitoring have enabled the study of maternal hemodynamics in normal and at-risk pregnancies.     This study hopes to identify the earliest significant changes in maternal hemodynamics which     may allow targeted therapeutic interventions in patients at high risk of developing     preeclampsia.      The hypothesis of this study is that systemic vascular resistance rises during the     pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance     technology. Treatment of the abnormally high vascular tone may decrease the severity and     postpone the onset of clinical disease.   "
147665|NCT01351415|"     This open-label, randomized, multicenter study will evaluate the efficacy and safety of     bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants     with advanced non-squamous NSCLC. Participants will be enrolled at documentation of     progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a     platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance     treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to     receive either bevacizumab plus SOC treatment or SOC treatment alone.   "
147666|NCT01351402|"     This study will investigate the effects of 15 minutes of massage compared to 15 minutes of     quiet rest on physiological variables. Specifically, the investigators will measure the     effects on levels of the social hormone oxytocin, and on other physiological variables that     interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin,     and IL-1alpha). The investigators will also investigate whether, in the case of hormones     changes, these influence social decision making.   "
147667|NCT01351389|"     This brief alcohol and sexual risk taking intervention has the potential to influence the     public health by reducing alcohol use and sexual risk taking behavior in individuals who are     seeking treatment in an Emergency Department.   "
147671|NCT01351337|"     Resection of brain tumors in eloquent areas involves the risk of postoperative motor     deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor     resection while preserving motor function is crucially important.we used DTI-based     tractography to visualize the spatial relationship between brain lesions and the nearby     pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional     connections of the illustrated PT by direct electrical stimulation. We evaluated the     reliability of DTI-based tractography for PT mapping using intraoperative subcortical     stimulation ) and the usefulness of the combination of two techniques.   "
147672|NCT01351324|"     Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and     insulin sensitivity but the impact of NEFA composition is unknown.      The objective was to test the effect of acute elevation of NEFA enriched with either     saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3     PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser     Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a     hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.   "
147673|NCT01351311|"     The aim of the present study is to assess the effectiveness of resistance training with swiss     ball in the treatment of patients with ankylosing spondylitis.   "
147674|NCT01351298|"     Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This     diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in     outpatients. The purpose of this randomized controlled double-blind study is to determine     whether there is a difference in the degree of discomfort experienced by children undergoing     flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo     (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C)     decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine     hydrochloride).      Null hypothesis: There is no difference in the degree of reported discomfort experienced     (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after     receiving either intra-nasal topical placebo, decongestant, or decongestant with local     anesthetic.   "
147675|NCT01351285|"     It has been reported that target-controlled infusion of remifentanil can reduce cough against     endotracheal tube during emergence from general anesthesia. We hypothesized that effective     concentration of remifentanil for preventing cough during anesthetic emergence varies     depending on the type of main anesthetic agents which is administered with remifentanil     during general anesthesia. The purpose of this study is to evaluate the effective     concentrations of remifentanil to prevent coughing during emergence from general anesthesia     according to main anesthetic agent (sevoflurane, desflurane, and propofol).   "
147676|NCT01351272|"     In this study the investigators will measure the functional brain activity of adult Attention     Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype,     during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH     for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic     effect of MPH treatment on cognitive functions.   "
147677|NCT01351259|"     Underinflation and overinflation of tracheal cuff are common in intubated patients, including     those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the     efficiency of a pneumatic device in controlling cuff pressure.   "
147678|NCT01351246|"     Cognitive-behavioral based guided self-help for parents of children with     Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and     effectiveness study. The treatment is offered under routine-care conditions of the     health-care system in Germany. Practicability, treatment participation and effectiveness is     documented and tested in a one-group pre-test/post-test design.   "
147679|NCT01351233|"     The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric     intraocular lens in the bag in high myopic subjects.   "
147680|NCT01351220|"     Filipino Americans have lower rates of colorectal cancer (CRC) screening, later stage of     diagnosis and poorer survival relative to other racial/ethnic groups. To address this     disparity, the investigators developed a multi-component intervention to increase CRC     screening and have determined its efficacy in a randomized trial (Maxwell,et. al., 2010).     This study aims to determine how an intervention to increase CRC screening can best be     integrated within the cultural norms and existing structures of churches and community based     organizations (CBOs) with predominantly Filipino American membership to ensure broad     dissemination to those in need of screening.      The investigators will provide our partner CBOs with resources and technical assistance,     including training of community volunteers as health advisors, to enable them to promote CRC     screening to their constituents. Using a scientifically rigorous research design, the     investigators will compare two dissemination strategies: Basic dissemination which consists     of a single kick-off event during which community health advisors will receive print     materials and FOBT kits for distribution and training on how to conduct educational     small-group sessions; and Organizational dissemination aimed at integrating CRC screening     dissemination into organizational practices and processes that can be sustained after the end     of the study. The study will be implemented in 20 CBOs and will train 100 community health     advisors (CHAs). The impact of the two dissemination strategies will be comprehensively     assessed by collecting data at the CBO level, from the CHAs and from 1000 Filipino American     participants. The investigators will compare the proportion of Filipino American participants     who obtain CRC screening by dissemination strategy, but the investigators will also assess     how many are reached, if the intervention is implemented as planned, how CBOs support the     screening efforts at their regular activities, and if CBOs and CHAs maintain their efforts     over the 4 years of the study.      The investigators hypothesize that CBOs can implement evidence-based strategies to promote     CRC screening and CHAs in the organizational dissemination arm will reach more participants     and more screened participants than CHAs in the basic dissemination arm; and organizations in     the organizational dissemination arm will adopt more CRC screening activities and maintain     these better than organizations in the basic dissemination arm.   "
147682|NCT01351194|"     Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms     of overall survival and disease-free survival. This has prompted some authors to suggest that     PRFA could be more suitable than HR for early stage HCC. Some authors also have suggested     that PRFA can be considered the treatment of choice for patients with single HCC ≤ 2.0 cm,     even when HR is possible. On the other hand, some tumors (subcapsular location, adjacent to     intestinal loops or main bile ducts) may be unsuitable for PRFA because of the risk of     bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our previous     experience, some tumors (with deep locations, which were included as central HCC) may be     also unsuitable for HR because of risks of more injury of normal liver tissue, blood loss     after resection, and so on. Therefore, the appropriate therapeutic option for these HCC     tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the     investigators conducted a study that included a consecutive series of patients with single     resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.   "
148796|NCT01336465|"     This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to     evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe     ulcerative colitis.   "
147683|NCT01351181|"     Type II diabetes is an important condition with a UK prevalence of 3.54% affecting     approximately 2.5 million people across the country. Diabetics have a fivefold increased risk     of cardiovascular disease and over 65% of diabetics will die from coronary heart disease or     stroke. Exercise is one of the management tools along with medication and weight reduction     available to improve diabetic control reducing morbidity and mortality. Exercise promotion     might be more effective at a population level if it could be incorporated in a simple form as     part of pre-existing routine care. This case control study seeks to assess the effectiveness     of written exercise advice given to Type II diabetics at the time of their annual review. The     study will be open to all Type II diabetics in a single general practice attending their     routine nurse led annual review. The intervention uses leaflets prepared as part of a     previous study the Time2Act study and assessment will be by self-reported questionnaires.     Follow up will be over 12 months but the study design will allow for longer durations.     Previous studies have demonstrated the effectiveness of exercise as an intervention but have     often been hospital-based and used exercise interviews as the main intervention rather than     incorporating exercise advice into structures already established in routine Primary Care. If     this study demonstrates that a simple intervention carried out as part of routine care has a     positive effect if only at a low level then disseminating this knowledge across the country     would bring significant benefits to Type II diabetics.   "
147684|NCT01351168|"     Levodopa treatment is associated with long-term complications. Dopamine deficiency is     associated with abnormal activity in certain parts of the brain. Zolpidem may change this     abnormal activity and, by doing so, may work in a different way than levodopa to help     parkinsonism.      The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving     motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind,     cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2     doses of ZLP in a randomized order on 4 different occasions, about one week apart.   "
147685|NCT01351155|"     In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV),     the main complication of the use of the mask is the development of decubitus, sometimes so     severe and painful as to force a suspension of the NIV itself . The lesions are mainly     located at the nasal bridge, as at this level the skin thin and placed directly on the bone     is particularly vulnerable to the injury as consequence of the friction and pressure induced     by the movement of the mask. The strategy of prevention and treatment commonly adopted is the     application of hydrocolloids.      However, precise data are lacking about the demonstration of the effectiveness of these     devices and the possibility of using other protective devices.      The purpose of this study was to evaluate the usefulness of large-scale three different     systems of protection vs. no protection in preventing the development of decubitus lesions in     patients receiving NIV for an episode of ARF.   "
147686|NCT01351142|"     Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks     of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in     the brain of patients with AD.      The main objective of our study is to analyse the correlation between the value of plasma     cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive     decline in AD over a 2-year follow-up.      Secondary objectives include:        -  the predictive value of the cytokines on the cognitive decline after 6 months and one          year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)        -  correlation between plasma cytokines levels and expression of the protein kinase PKR          (involved in death cell) in blood mononuclear cells.   "
147687|NCT01351129|"     The primary purpose of this study is to evaluate the pharmacokinetics, safety and     tolerability three different formulations of PF-04991532 in healthy adult subjects.   "
147688|NCT01351116|"     A trial to improve the quality of life of patients with advanced non-small cell lung cancer     (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external     radiation with or without high dose internal radiation.   "
147689|NCT01351103|"     This primary purpose of this study is to find the recommended dose of LGK974 as a single     agent and in combination with PDR001 that can be safely given to adult patients with selected     solid malignancies for whom no effective standard treatment is available.   "
147690|NCT01351090|"     This was a randomized, double blind, placebo-controlled study in subjects who have undergone     major surgery. Each subject's study participation consisted of a screening visit, a 2-day     treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned     to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain     intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter,     subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain     not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered     via patient controlled analgesia (PCA).      The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN)     doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and     tolerability of this dosing regimen.   "
147752|NCT01350284|"     The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the     gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood     glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a     healthy adult population.   "
147691|NCT01351077|"     The aims of this study are to (1) Expand and modify an existing computer-based decision     support system (CHICA) to include the 2006 AAP developmental surveillance and screening     algorithm; (2) Evaluate the effect of the CHICA system on the developmental surveillance and     screening practices of four pediatric clinics; (3) Evaluate the effect of the CHICA system on     referrals for developmental and medical evaluations as well as early developmental     intervention/early childhood services for those children identified as having concerning     developmental screening results; and (4) Develop a cohort of children with identified     developmental disabilities that can be followed over time in order to look at the end     results/effects of developmental screening   "
147721|NCT01350687|"     Pulmonary hypertension is a new complication described in hemodialysis patients. in the last     year these patients were treated by calcium carbonate orally to control serum phosphor.     Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators     want to investigate the new phosphor non calcium containing agents in hemodialysis patients     and to measure the pulmonary pressure.   "
147692|NCT01351064|"     Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral     disorder in children. Prevalence rates in the United States range from 2% to 18% depending on     diagnostic criteria and population studied. Primary care physicians, especially     pediatricians, have historically played a large role in the diagnosis and treatment of ADHD.     Despite the existence of authoritative guidelines to assist primary care physicians, ample     evidence demonstrates that they continue to diagnose and treat this disorder suboptimally.     This is due, in part, to a lack of training and cumbersome delivery system designs. Modern     computer decision support strategies offer the best hope of equipping general practitioners     to deal with the mental health epidemic of ADHD.      The investigators have developed a novel decision support system for implementing clinical     guidelines in pediatric practice. CHICA (Child Health Improvement through Computer     Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a     dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing     electronic medical record systems. The result is a system that both delivers just-in-time     patient-relevant guidelines to physicians during the clinical encounter, and accurately     captures structured data from all who interact with it. Preliminary work with CHICA has     demonstrated the feasibility of using the system to implement and evaluate clinical     guidelines. The investigators propose to expand CHICA to include ADHD diagnosis and treatment     guidelines. The investigators hypothesize that implementation of the ADHD guidelines will     result in better outcomes, including higher rates of adherence to recommendations and     improved patient functioning.   "
147693|NCT01351051|"     This study will aim to identify genetic, medical, dietary and environmental factors     associated with the development of endometrioma and/or deep infiltrating endometriosis in     order to move towards early diagnosis and implementation of potential preventative measures.   "
147694|NCT01351038|"     This is an open label, multicenter, single-arm phase II trial with primary     eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with     resectable, histologically proven gastric or esophageal cancer.   "
147695|NCT01351025|"     ACTG A5275 was a prospective, double-blind, randomized, placebo-controlled cross-over design     pilot study evaluating the effect of atorvastatin on biomarkers of inflammation,     coagulopathy, angiogenesis, and T-lymphocyte activation in HIV-1 infected individuals with     suppressed HIV-1 RNA on stable protease inhibitor based antiretroviral therapy with fasting     LDL cholesterol < 130 mg/dL.      Atorvastatin is a drug approved by the Food and Drug Administration (FDA) for treating high     cholesterol. Atorvastatin has also been able to lower the level of inflammation blood tests     in certain other diseases but has not been studied for this purpose in people who have HIV.     The main goal of this experimental study is to see how taking atorvastatin affects     inflammation blood tests in people infected with HIV who do not need to take medicine for     high cholesterol. In addition to observing the effects of atorvastatin on the level of     inflammation measured in the blood, this study evaluated if atorvastatin is safe for people     with HIV who are also taking medication for HIV.   "
147696|NCT01351012|"     The purpose of the study is to examine how the consumption of different dietary oil varieties     affects a broad range of metabolic responses that are important in the development of     cardiovascular diseases. This study will examine the relationship between dietary oil     consumption and arterial function, blood fat content, and blood markers of cardiovascular     disease risk. Additionally, the efficiency of the body in converting fat from dietary oils     into other specific fat compounds with know health benefits will be examined. Also, the     correlation between psychosocial parameters and vascular function will be studied.   "
147697|NCT01350999|"     The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD)     or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in     participants with hypertriglyceridemia undergoing lifestyle modification.   "
147698|NCT01350986|"     The efficacy of cognitive-behavioral based guided self-help for parents of children with     externalizing problem behavior is tested in a randomized clinical trial. Parents work through     cognitive-behavioral self-help booklets and additionally receive counseling telephone calls     every two weeks. In the control condition parents are provided non-directive self-help     booklets and additionally receive counseling telephone calls. It is hypothesized that the     cognitive-behavioral treatment is superior.   "
147699|NCT01350973|"     The purpose of this study was to determine the efficacy and safety of TAK-085, once daily     (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily     (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.   "
147700|NCT01350960|"     The purpose is to study Safety and Tolerability.   "
147701|NCT01350947|"     The primary objective of this study is:      Response to treatment will be evaluated according to the revised International Working Group     (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The     primary objective is:      To determine the rate of complete hematologic response and hematologic improvement (according     to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.   "
147702|NCT01350934|"     This study will evaluate whether the once weekly administration of the combination tablet     alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD)     more than the daily use of calcitriol.   "
147703|NCT01350921|"     Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken     together in healthy volunteers   "
147704|NCT01350908|"     Circulating tumor DNA detection and quantification in patients with ovarian cancer.   "
147705|NCT01350895|"     To study the clinical and biochemical characteristics women with polycystic ovary syndrome     (PCOS) in different aged groups.   "
147720|NCT01350700|"     In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed     by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of     enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not     other parts of the skin).      The burn wound, like any other wound, heals by the formation of scar at the injured site in     order to replace the destroyed tissues. Scarring is not a static process, but rather a     dynamic one, changing over time, especially during the first 24 months post-injury.      Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in     order to evaluate the long term influence of damaged skin removal and wound care techniques     on scar formation and maturation.   "
147708|NCT01350856|"     Because the artemisinins are the most potent antimalarial drugs, the reduction in parasite     numbers is rapid. Therefore, early measures of reducing parasite counts are needed. This     study will look at conventional markers of parasite reduction e.g. parasite clearance time,     parasite reduction ratio, and the time to achieve a fall of 50%, 90% and 99% of the     pre-treatment parasitaemia.      Defining artemisinin resistance requires the use of artesunate (AS) alone because it is now     appreciated that the partner drug in a combination treatment has a significant impact on the     rate of parasite clearance. This study will dose patients for 3 days with AS alone (or longer     until parasites clear) and measure the parasite count frequently in order to be able to     define an accurate regression line of a graph of the natural logarithm of the parasite count     (Y axis) versus time (X axis). This will be followed by a full course of an artemisinin     combination therapy (ACT). Two different dose regimens of artesunate will be compared at all     sites except those in western Cambodia, as unpublished observations from the Thai-Myanmar     border suggest the standard lower daily dose of 2mg/kg may enable the earlier detection of     low level resistance than a 4mg/kg daily dose.   "
147709|NCT01350843|"     The aim of this study is primarily to investigate the ability of antioxidants found in orange     juice (OJ) to improve the serum lipid profile. Overweight or mildly obese men, who are     otherwise healthy, but with elevated serum total cholesterol concentration will be recruited.     The time commitment for subjects is ~14wks. Subjects will attend the laboratory on 5     occasions after fasting from midnight. The 1st is a medical screening. Laboratory visits 2 &     5 will take ~90min and will be separated by 3 months, during which time subjects will consume     250ml of an orange drink (either OJ or an orange flavoured control drink) once a day. During     visits 2 & 5, subjects will have a scan to assess their %body fat using a low-dose x-ray     machine, a 20ml blood sample taken and a small sample of fat tissue (about the size of a     haricot bean)taken from underneath the skin of the belly. Subjects will record their food     intake for 3-days in weeks 3, 7 and 11 of consuming the drink, and come to the lab for visits     3&4 during weeks 4&8. Laboratory visits 3&4 repeat measurements taken in the 1st (screening)     visit.   "
147710|NCT01350830|"     Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two     anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space     to assess any differences in term of chronic pain and early and late complications   "
147711|NCT01350817|"     This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib     plus docetaxel therapy versus docetaxel alone as second line treatment in patients with     recurrent non-small cell lung cancer. Patients will be randomized to receive in group     1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per     os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.      The anticipated time on study treatment is until disease progression. Target sample size is     156.      The main of this study is to determine the relevance of the association sequential erlotinib     and docetaxel in terms of progression-free survival .   "
147712|NCT01350804|"     The core and extension studies assessed the safety and efficacy of secukinumab when added to     a background therapy in patients with active rheumatoid arthritis who are intolerant to or     have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab,     placebo or abatacept (active comparator). The core study was completed. However, the     extension study was prematurely terminated after the primary endpoint analysis of the core     study at week 24 had demonstrated numerically higher efficacy for the active comparator     abatacept compared to secukinumab.   "
147713|NCT01350791|"     This study is a non-randomized, prospective, open-label registry to compare the efficacy and     safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients     with coronary artery disease.   "
147714|NCT01350778|"     The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the     real world daily practice as compared with first-generation drug-eluting stents (sirolimus-     or paclitaxel-eluting stents).   "
147715|NCT01350765|"     The present study will be carried out in close collaboration with the National Program for     Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering     60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional     Birth Attendant will provide care to the mothers and newborns at household level. A Basic     Health Unit will take care of non complicated referrals and provide injectable antibiotics     for neonatal sepsis. Complicated (definitions given in methods section) cases will be     referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning     neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of     Health, Sindh and the Federal Ministry of Health are study collaborators, therefore,     guaranteeing scaling up of interventions at national level.      Hypothesis:      In comparison to a basic package of existing training program of LHWs, enhanced training of     LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn     infections and LBW (combined with prompt referral) will result in an additional 30% reduction     in neonatal mortality.   "
147716|NCT01350752|"     The objective of the REACT project is to evaluate the effectiveness and cost-effectiveness     implications of interventions designed to improve health worker practice in providing     treatment for uncomplicated malaria to febrile patients attending health facilities in     Cameroon and Nigeria.   "
147717|NCT01350739|"     The aim of this study is to access to the abdominal cavity using different incision-types     within the umbilical area.      Effects of different incisions on scarring and on the umbilical form will be investigated.   "
147718|NCT01350726|"     The aims of this study were divided into three parts:        1. To develop a new software to carry out the functional-three- dimensional-reconstruction          of the liver by 99mTc-GSA-SPECT scintigraphy        2. To probe a new dynamic model of the metabolism of the 99mTc-GSA.        3. To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical          treatment.      Study design:        1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.        2. Patients: The subjects were from different hospitals including: Peking Union Medical          College Hospital (PUMCH).      Study arrangement:      This study was consisted of three parts:   "
148007|NCT01346956|"     Twenty healthy smokers will be subjected to measurement of Pulse, Blood Pressure,     electrocardiogram (ECG) and Echo at baseline and after smoking a cigarette. The measurements     will be compare for any cardiovascular effects of a cigarette smoking on these parameters.   "
147722|NCT01350674|"     This is an observational prospective study. Role of EBUS-TBNA (endobronchial ultrasound     transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal and/or     hilar lymph nodes.      The investigators analyse the specificity and sensibility of this technique to diagnose     tuberculosis in mediastinal and/or hilar lymph nodes.      Patients with mediastinal and/or hilar lymph nodes on X-ray or CT thorax where a tuberculosis     is the most probable cause and who have no parenchymal lesions suspected for tuberculosis and     without other lymph nodes that are more easily accessible or palpable will be included in     this study.   "
147723|NCT01350661|"     This observational study aims to assess the correlation between many questionnaires designed     to assess the level of control of asthma. The five questionnaires will be submitted, at the     same time and in a random order, to asthma patients. Some other parameters will be recorded     (e.g. lung function, epidemiological data). The hypothesis is that the results of the     questionnaires will be the same. If not, we will try to understand why.      The investigators will include 100 patients, stratified with relation to their level of     asthma severity (25 patients for each level of severity - described by the GINA guidelines).   "
147724|NCT01350648|"     Background:      - Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness,     including liver cancer, and even death. This study will follow people who have hepatitis B or     hepatitis C. The purpose is to understand more about how these viruses affect the immune     system over the long term (up to 10 years). The study will also compare how these viruses     affect people who do and do not have HIV, the virus that causes AIDS.      Objectives:        -  To do a long-term study of hepatitis B and hepatitis C infection.        -  To study the effects of hepatitis B and hepatitis C infection in people do and do not          have HIV.      Eligibility:      - People at least 18 years of age who have hepatitis B or hepatitis C and have a regular     doctor for their medical care.      Design:        -  Participants will be screened with a physical exam and medical history. Those who do not          have a regular doctor to provide medical care during the study will not be able to take          part.        -  Participants will have yearly visits with study researchers for up to 10 years. These          tests will be done at each visit.        -  Medical history and physical exam.        -  Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and          quality of life.        -  Blood and urine tests, including HIV testing.        -  Tissue sample collections for those who have had a liver or other tissue biopsy.        -  Participants may leave the study at any time. They will receive the standard of care          from their regular doctor throughout the study.   "
147725|NCT01350635|"     The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins     exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to     grass pollen allergic patients   "
147726|NCT01350622|"     The primary objective of this study is to compare the pain relieving effect and speed of     onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a     growth curve approach to pain measurement. The investigators will test the hypothesis that     PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The     secondary goal of the proposed work is to discover and model the onset and course of pain     relief during the emergency department (ED) visit.   "
147727|NCT01350609|"     Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence     of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the     corresponding loose combination under fed conditions.   "
147728|NCT01350596|"     An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the     pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral suspension     versus alivium ® 50mg/ml (mantecorp indústria química e farmacêutica ltda.) Oral suspension,     in healthy fasting volunteers.   "
147729|NCT01350583|"     The purpose of this study is to:        -  Determine how well people tolerated sodium bicarbonate taken by mouth in higher doses          than those usually given for heartburn.        -  Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the          investigators do not know for sure if these higher doses will be well tolerated or if          they will reduce the pain associated with cancer. The investigators are doing this study          to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for          pain medications.   "
147730|NCT01350570|"     This trial is to assess the effectiveness of three types of acupuncture for patients with     functional diarrhea comparing to a positive drug control.   "
147731|NCT01350557|"     Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility     problems that usually results in costly hospital stays and lengthy rehabilitation procedures.     The purpose of this study is to compare the costs and effectiveness of three care models-     acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.   "
147732|NCT01350544|"     The investigators hypothesize that participants in the treatment advocacy intervention will     show significantly better HIV treatment adherence than will participants in the no-treatment     (wait-list) control group.   "
148008|NCT01346943|"     The purpose of this study is to evaluate the safety of deploying and implanting the Altura     Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in     subjects who are candidates for open surgical aneurysm repair.   "
147753|NCT01350271|"     Mebendazole tablets which are produced by most pharmaceutical manufacturers, including the     State Pharmaceutical Manufacturing Corporation (SPMC) of Sri Lanka, contain a mixture of     polymorphs A and C. However, there is some evidence to show that mebendazole polymorph C is     the only form effective against the soil-transmitted helminths. This protocol describes a     stratified, randomized, placebo-controlled trial that examined the efficacy of different     mebendazole polymorphs produced by the SPMC in the treatment of hookworm infections.   "
147843|NCT01349101|"     It is hypothesized that engraftment when administering cyclophosphamide post the stem cell     infusion will increase, the incidence of graft versus host disease (GVHD) and day 100     mortality will decrease, and the use of cyclophosphamide post stem cell infusion with     alternative donors will be as safe and as effective as traditional matched transplants.   "
149269|NCT01330290|"     The study objective is to evaluate advantages and disadvantages of Neupro® versus oral     anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease     patients requiring caregiver support in nursing home or outpatient care settings.   "
147733|NCT01350531|"     To date, attempts to construct effective weight loss interventions for African American     adolescents with obesity (AAAO) have largely failed. While effective weight loss strategies     and skills have been identified, lifestyle changes require youth and their families to learn     new dietary and exercise behavior with repeated skills practice in natural ecology of the     family. A major barrier is motivation of both parents and adolescents to engage in treatment     and to adhere to behavior change recommendations. Advances in the science of increasing human     motivation (both intrinsic and extrinsic) that could inform intervention development for     minority youth with obesity have been insufficiently applied to date to the process of     intervention development. The study brings together a multidisciplinary research group     comprised of obesity intervention researchers with extensive experience in adolescent health     behavior change research, basic behavioral scientists with experience in motivation and     learning research and communication scientists with experience in provider-family     interactions within urban populations. Basic science obesity researchers will inform     intervention development by contributing a strong background in the physiological correlates     of obesity. Finally experts in the area of community interventions for African American     adolescents will contribute to the effective transport of these interventions to real-world     settings. The overarching aims of the study are: To refine intervention protocols from our     preliminary studies that maximize adolescent and parent skills, informed by learning theory,     through the use of home and community-based interventions in which in-vivo opportunities are     used to promote practice in making changes in dietary, exercise and sedentary behaviors in     AAAO and their families (PHASE I); To develop intervention protocols that utilize findings     from basic science regarding intrinsic and extrinsic motivation to maximize adolescent and     family adherence to recommendations for obesity-related behavior change in AAAO and their     families (PHASE I); To develop an adaptive intervention using a sequential multiple     randomized assignment trial (SMART design) (PHASE II); To refine the intervention including     qualitative analysis of interviews from participant families and to develop further community     participation in preparation for a confirmatory randomized clinical trial (PHASE III).      There are two proposed hypotheses for this study:        1. Families initially receiving home/community delivery of Motivational Interviewing          (MI)/skills training will show greater weight loss over the course of the study than          families receiving initial office-based delivery of MI/skills training.        2. Non-responders receiving home/community delivery of MI/skills training with Contingency          Management (CM) will show greater weight loss than non-responders receiving MI/skills          training alone.   "
147735|NCT01350505|"     To examine the change in balance that occurs in older individuals when exposed to different     colored lights at night.   "
147736|NCT01350492|"     This study is intended to test the influence of weight training on physical symptoms,     physical activity and brain structure and function in Gulf War Veterans with chronic     widespread muscle pain.   "
147737|NCT01350479|"     Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and     mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by     health care workers. The use of gowns, gloves and hand washing prevents this spread; however,     their use detracts from a patient-centered, home-like environment which is an important     priority for nursing homes. The goal of this project is to determine when it is most     important for health care workers to wear gowns and to wash their hands when caring for MRSA     colonized Veterans in community living centers.   "
147738|NCT01350466|"     The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune,     infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus     surgery (FESS) is the therapy of choice. From literature it is known that 10% of patients     that undergo FESS, need revision surgery within the 3 years following initial surgery. Causes     of failure are multiple and not fully understood.      As is the case in patients suffering from occupational rhinitis (OR), a subgroup of patients     with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology induced     by occupational factors as well. No data are currently available on how these factors may     contribute to the disease manifestation, whereas negligence of these factors as potential     causes of disease may lead to the chronicity of rhinosinusitis, aggravate the mucosal     condition and even give rise to the induction of bronchial symptoms. There exists no     documentation on the role of the occupational agents on chronic sinus disease.      This prospective study aims at providing data about the exposure levels of patients that     undergo sinus surgery and correlate them with both subjective and objective postoperative     parameters. This will be done by providing a questionnaire that was developed at our     department to all patients that are planned for sinus surgery at the participating centers.     This questionnaire asks for medical history, current sinonasal symptoms, professional history     and recreational occupation. An extensive list of occupational agents is given and patients     are asked to indicate those that they encounter at work or during recreational activities.     This will be followed by an extensive clinical investigation including nasal endoscopy. These     investigations (questionnaire and clinical examination) will be repeated at 3 months and 12     months after surgery.   "
147739|NCT01350453|"     When a person has had a stroke they often lose their confidence, motivation and the ability     to move one arm and hand. Recent research has shown that intensive exercise assists recovery     of movement, but people are often discouraged by slow progress and stop using their weak     limb.      A new idea, called Constraint Induced Therapy (CIT), has been shown to overcome this habitual     'non-use'. CIT involves wearing a mitt on the unaffected hand for several hours a day to     prevent it from being used. Use of the weak arm and hand is encouraged by intensive     exercises. CIT is not available in the NHS because of lack of therapist time for supervision     and patients lack the confidence and motivation to carry out CIT alone at home.      This study will have two stages.      Stage 1.      The aim of this part of the study is to develop a web-based therapy programme ('LifeCIT') to     support patients carrying out CIT at home (with their carer where possible) with online     therapist support. The investigators will develop the therapy programme working closely with     at least 12 patients, 6 carers and 6 therapists to identify and resolve any problems.      Stage 2      The investigators will then carry out a pilot trial in three centres with 40-60 patients who     have just been discharged from hospital and who have loss of arm and hand function. To test     LifeCIT the investigators will randomly allocate patients to receive either the LifeCIT     intervention or usual care. A researcher, who doesn't know which group patients have been     allocated to, will measure their arm and hand function, record the problems this causes and     how it affects their quality of life. Tests will be repeated after treatment (3 weeks) and 6     months later. The investigators will also examine the cost-effectiveness of treatment and ask     both therapists and patients for their views.   "
147740|NCT01350440|"     This is a preliminary study to determine the safety and efficacy of intravenous immune     globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in     clinical measures of disease severity before and after treatment.   "
147741|NCT01350427|"     This study aims to evaluate the effects of leucine and branched-chain amino acids     supplementation on skeletal muscle remodeling signaling pathways induced by resistance     exercise.   "
147815|NCT01349465|"     The purpose of this study is to investigate durability of SVR in chronic HCV patients who     achieved SVR in the previous study with TMC435-containing regimen and time for resistance     associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in     the previous study with TMC435-containing regimen.   "
147816|NCT01349452|"     Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of     herpetic keratitis and shows potential for effectiveness against other viral ocular     infections. The majority of adenoviral conjunctivitis will resolve without damaging vision,     however, the investigators have no way to determine which cases will progress to ocular     complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate the     efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after adenoviral     conjunctivitis.   "
147742|NCT01350414|"     The objective of this study is to evaluate durability of effectiveness (beyond one year) of     the Alair System in patients with severe persistent asthma. The study will consist of     Alair-group subjects who are currently in the follow-up phase (out to 5 years) of the AIR2     Trial (Protocol #04-02, clinicaltrials.gov number NCT00231114).      Durability of the treatment effect will be evaluated by comparing the proportion of subjects     who experience severe exacerbations during the first year after Alair treatment with the     proportion of subjects who experience severe exacerbations during subsequent 12 month periods     out to 5 years.      All Alair group subjects in the AIR2 Trial are being followed out to 5 years as per the AIR2     Trial protocol. The data that are to be used to determine durability of effectiveness as     described in the present protocol (Protocol #10-01) are being collected under the existing     AIR2 Trial protocol (Protocol # 04-02).      Study Hypothesis: An empirical demonstration of the durability of the treatment effect will     be used to show that the proportion of subjects experiencing severe exacerbations for the     first year compared with the proportions of subjects experiencing severe exacerbations in     subsequent years do not get substantially worse.      The primary statistical objective is to demonstrate that the proportion of subjects who     experience severe exacerbations in the subsequent 12-month follow-up (for Year 2, Year 3,     Year 4 and Year 5 [in 12-month periods]) is not statistically worse when compared with the     proportion of first 12-months, which begins 6-weeks after the last Alair treatment. This     objective will be met if the upper 95% confidence limit of the difference in proportions     (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than     20%.   "
147743|NCT01350401|"     The purpose of this early (phase I/II) clinical trial is to assess the effects (both good and     bad) of genetically modified T cells after chemotherapy on your cancer and general health.   "
147744|NCT01350388|"     Hyperuricemia is emerging as a risk factor for development of diabetes and metabolic     syndrome. Recently, it was shown in in-vitro cell culture experiments that hyperuricemia     induces redox-dependent signaling and oxidative stress in adipocytes. By targeting levels of     uric acid with febuxostat it is hypothesized that the levels of oxidative stress in adipose     tissue (obtained by fat biopsy) will decrease.      Primary aims of the study are to determine whether febuxostat therapy in overweight or obese,     diabetic patients with stage 3 Chronic Kidney Disease (CKD) and high serum uric acid levels        1. will affect adipose tissue concentrations of thiobarbituric acid reactive substance          (TBARS), a marker of oxidative stress        2. will affect adipose tissue expression and concentrations of adiponectin; and        3. will affect urinary concentrations of transforming growth factor (TGF)- B1.   "
147745|NCT01350375|"     This study will investigate the therapeutic utility of BOTOX in reducing the degree of     Forward Head Posture (FHP) with associated headache and myofascial pain, decreasing the     frequency of headache, and improving the overall quality of life.   "
147746|NCT01350362|"     The main purpose of this study is to evaluate the cognitive changes after administration of     tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in     patients with mild to moderate Alzheimer's disease.      After the 26 week core treatment period, the patients may continue in the study under blinded     conditions for an optional extension period up to a maximum of 39 additional weeks (total     study duration up to 65 weeks), until the last patient in the study has completed the 26 week     of treatment.   "
147747|NCT01350349|"     Among older adults the combination of depression, cognitive impairment (memory problems), and     disability contribute to a worsening of physical and mental health and to poor treatment     outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems     achieve remission from their depression. Interventions involving talking therapy are     underdeveloped and understudied. Therefore, this research study will test the efficacy of     Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders     with major depression, memory problems, and disability. PATH focuses on the subject's     ecosystem (the patient, the caregiver, and the home-environment) and targets behavioral     problems related to both depression and disability.      PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most     of their difficulties. Local Home Delivered Meals programs will refer clients who have     symptoms of depression and are interested in research. All participants will have an     available caregiver (family, significant other, or professional) and will be randomized to 12     weekly sessions of PATH or Supportive Therapy, the current standard of care for talking     therapy. The study will test whether home-delivered PATH is more effective than     home-delivered Supportive Therapy in reducing the subjects' depression and disability and in     increasing self-efficacy over the 12-week treatment period.   "
147748|NCT01350336|"     As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific     to generate data to assess the durability of the BT treatment effect as well as safety data     in the intended use population in the United States.   "
147749|NCT01350323|"     This is a pilot, prospective, interventional, case-control study investigating aqueous levels     of vascular endothelial growth factor (VEGF) in eyes with AMD-related neovascularization     treated with intravitreal bevacizumab at the Medical Retina Department, University of Molise,     Campobasso.   "
147750|NCT01350310|"     BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell     transplantation has been shown to improve exercise capacity, reduce ventricular remodelling     and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the     diseased heart can be further enhanced by direct intramyocardial delivery route.      AIMS.        1. To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with          non-ischemic dilated cardiomyopathy.        2. To directly compare clinical effects of intracoronary and intramyocardial stem cell          delivery.      METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to intramyocardial     transplantation of CD34+ cells (Study Group), and 30 will receive intracoronary stem cell     therapy (Control Group). In both groups peripheral blood stem cells will be mobilised by     daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and     labelled with technetium. In the Study Group electromechanical mapping will be used to     identify viable myocardium and intramyocardial injections in the target areas will be     performed with NOGA catheter. In the Control group patients will undergo myocardial perfusion     scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments     of reduced viability. Patients will be followed for 1 year. Primary endpoints will include     changes in left ventricular ejection fraction and left ventricular dimensions (measured by     echocardiography). Secondary endpoints will include changes in exercise capacity and changes     in NT-proBNP values.      HYPOTHESES.        1. At 1 year, intramyocardial stem cell therapy will be associated with improved left          ventricular ejection fraction, reduced left ventricular dimensions, improved exercise          capacity and reduced levels of NT-proBNP.        2. Beneficial effects of intramyocardial stem cell therapy will be superior to those          observed with intracoronary stem cell delivery.   "
147751|NCT01350297|"     This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in     tetraplegic patients with ventilatory insufficiency.   "
147754|NCT01350258|"     This is a research study involving the treatment of patients with hematological cancers with     allogeneic (cells from a donor) hematopoietic stem cell transplant (HSCT). HSCT is often     referred to as bone marrow transplant. Patients who are not expected to have long term     survival after conventional therapy will undergo HSCT as a curative therapy after receiving     front line therapy for their disease. This project is based on an HSCT approach that has been     used at TJU since 2006 with the goal of optimizing this type of treatment further. In this     new study, the investigators will substitute the chemotherapy agent, Melphalan (Mel), for     cyclophosphamide (CY). Cyclophosphamide was used in the original trial. The research question     is whether side effects are less using Mel and if donor T cells can be made tolerant to the     recipient with the use of Mel. The proposed study is also more specific in terms of     performance status and organ function entry criterion. The investigators observed in the     original trial that patients with poor performance upon admission for transplant did not have     as good outcomes.      Because many older patients are treated according to this type of transplant, the     chemotherapy and radiation used are less intensive than other types of transplant. The name     for this in the transplant field is a reduced intensity hematopoietic stem cell transplant.     The abbreviations most used in this document are RIC for reduced intensity conditioning, HSCT     which refers to the transplant itself, and MEL which refers to the drug, Melphalan.   "
147755|NCT01350245|"     The primary hypothesis of this research study is that patients in remission undergoing     myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas     Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS)     rate at 1 year that is the same or better than the historical DFS of patients with similar     diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS     rate of 50% or better at 1 year would meet the criterion for an effective alternative     therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach     over T-replete matched sibling HSCT.   "
147756|NCT01350232|"     This is a clinical research trial in which a novel preparatory regimen was developed for bone     marrow transplant (BMT) which eliminates the primary obstacle to transplant, the lack of a     matched sibling donor. It is believed this regimen is sufficiently efficacious and     sufficiently gentle to apply to patients with sickle cell anemia and related disorders. It is     proposed to characterize the efficacy and toxicity of this regimen in high risk patients with     sickle cell anemia using criteria for patient selection that have been accepted in prior BMT     trials in patients with sickle cell disease, specifically only the subset of patients whose     prior clinical behavior indicates that they are at high risk for serious morbidity and early     mortality. In addition, it is proposed to characterize the pathophysiology of a consistent     febrile response seen in the haploidentical BMT regimen the investigators have developed at     Thomas Jefferson University (TJU).      The primary goal of this study is to determine the response rate to a reduced intensity     conditioning regimen which consists of fludarabine, cytarabine, low dose total body     irradiation and cyclophosphamide in patients with severe sickle cell anemia.   "
147757|NCT01350219|"     The translational potential to the clinical applications of cord blood stem cells has     increased enormously in recent years, mainly because of its unique advantages including no     risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid     availability, and large resource worldwide. Human cord blood contains several types of stem     cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess     multiple biological properties including the expression of embryonic stem (ES) cell     characteristics, giving rise to different types of cells and immune modulation. Specifically,     CB-SC can function as an immune modulator that can lead to control of the immune responses,     which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes     (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel     Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of     Educator therapy in T1D patients.   "
147758|NCT01350206|"     The treatment for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT) is     still controversial, and there is no universally agreed protocol for its treatment.     Transarterial chemoembolization (TACE) has become the most popular palliative treatment for     patients with unresectable HCC, and it is no longer considered as a contraindication to HCC     with PVTT. Unfortunately, the long term outcomes are generally poor for HCC treated with     TACE, especially for HCC with PVTT. HR remains the only therapeutic option that may still     offer a chance of cure. With advances in surgical techniques, it has become feasible to     remove all gross tumors, including PVTT which has extended to the main portal vein, safely by     surgery. This study aimed to evaluate the safety and efficacy of HR as compared with TACE to     treat patients with HCC with PVTT. The investigators also aimed to identify patient groups     that might benefit more from either treatment with HR or TACE.   "
147769|NCT01350063|"     When shallow tubewells replaced highly contaminated surface water as the primary source of     drinking water in Bangladesh in the late 20th century, contemporary studies demonstrated no     reduction in diarrheal disease with this improvement in water source. This lack of     improvement in transitioning to tubewells is consistent with the lack of significant health     gains observed in intervention studies focusing on water quality improvements at the source.     In contrast, high quality intervention studies that improve water quality at the point of use     through treatment of water in households show a 39% reduction in diarrhea.      The primary objective of this study is within a typical setting in rural Bangladesh where     households use shallow tubewell water for drinking. The investigators will randomly assign     1800 households who have a child between the ages of six months and two years to one of three     groups. Group 1 will receive a safe water storage vessel with a lid and a narrow mouth/tap     and Aquatabs, an effervescent water purification tablet that utilizes sodium     dichloroisocyanurate (NaDCC) as the chlorine donor. Group 2 will only receive a safe water     storage vessel with a lid and a narrow mouth/tap. Group 3 will receive no water intervention     and continue their standard habits and practices. Every month a field research assistant will     visit each participating household and collect information on the prevalence of diarrhea     among children between the ages of six months and two years, as well as children between the     ages of two and five years if present in the household. Diarrhea prevalence in the 48 hours     and 7 days preceding the visit will be recorded. The investigators will compare the     longitudinal prevalence of diarrhea between the following groups: (1) households that receive     chlorine and storage container versus households that only receive storage container to     assess the effect of chlorination, (2) households that only receive storage container versus     households that receive no intervention to assess the effect of safe storage, and (3)     households that receive chlorine and storage container versus households that receive no     intervention to assess the combined effect of chlorination and safe storage.      Hypothesis:      Drinking water from shallow tubewells that are intermittently contaminated with enteric     pathogens contributes importantly to diarrhea among children in rural Bangladesh.   "
147817|NCT01349439|"     The purpose of this study is to test whether propranolol is capable of reducing subsequent     physiological trauma-related conditioned responses, as well as self-reported post-traumatic     stress disorder (PTSD) symptoms.   "
149283|NCT01330082|"     The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the     adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source     in the treatment of chronic periodontitis.   "
147759|NCT01350193|"     All adult (over 19 years) patients undergoing sinus surgery for chronic rhinosinusitis (CRS)     or allergic fungal sinusitis (AFS) that do not meet the exclusion criteria will be included     in the study.      All participants enrolled in the study will receive antibiotic (Clavulin) therapy 1-week     pre-and post-operatively and oral steroid therapy 1-week pre-operatively and     post-operatively.      Randomization of patients to the Manuka Honey irrigation (treatment arm) and Saline     irrigation (standard of care) will occur on the day of surgery.      Participants in both study arms will undergo the standard post-operative endoscopic sinus     surgery follow-up. This includes follow-up appointments at 6 days, 5 weeks, 3 months, and 6     months of the post-operative period. During these appointments, the surgeon will assess the     post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain,     and 1st week post-operative bleeding (only at 6 day visit).      The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study     participants at 6 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a     5-minute questionnaire consisting of 22 questions, which asks participants to rate their     sinus symptoms and social/emotional consequences of their nasal disorder from no problem to     problem as bad as it can be.   "
147760|NCT01350180|"     One of the biggest problems facing prostate cancer patients and their treating physicians is     who needs to be treated and when. Common clinical and pathological parameters are useful     (PSA, Gleason score, etc.) but do not clearly predict who will benefit from treatment and who     will fail. Genetic markers for tumor aggressivity would be of greater value. The finding that     the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression is     important. TMPRSS2 is controlled by androgen (testosterone) and ERG is part of a family of     proteins which have a role in controlling cell growth, cell specialization and producing     tumors. As a consequence of this gene fusion, production of the ERG protein increases in the     presence of testosterone and could be key to the development of prostate cancer, resistance     to treatment and poor outcome. The PTEN gene is known to have a role as a tumor suppressor.     Its deletion is a contributing factor in the development of prostate cancers and poor     outcome. The coexistence of the two markers could be associated with a higher risk of     recurrence.      To date there have been no studies regarding the presence of either of these two markers or     their coexistence in high risk prostate cancer patients who, despite radiation therapy and     androgen suppression, develop biochemical failure (their PSA levels rise once again).     Patients participating in the PCS IV study (high risk prostate cancer treated with radiation     therapy plus either 18 or 36 months of hormonal suppression) who have had biochemical failure     or 3 years of follow-up post hormonal therapy will be approached.      Tumor blocks from consenting patients will be collected and analyzed for the presence of the     TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish     General Hospital. Statistical analysis will be carried out to see whether either or both     markers are present, whether they are associated with certain clinical and pathological high     risk factors, and whether they can be used to predict which patients will fail treatment.   "
147761|NCT01350167|"     The purpose of this study is to determine whether ultrasound or CT scanning is more effective     at detecting early liver cancer in patients with advanced liver disease.   "
147762|NCT01350154|"     This study is done to evaluate whether treatment with the drug sildenafil (Revatio®) can     improve muscular, cardiac, cerebrovascular or cognitive function in patients with Beckers     muscular dystrophy when compared to placebo (inactive medication). The study is based on the     recent findings of an improved cardiac function in a mouse model of muscular dystrophy (Adamo     et al 2010) and the previous findings of changed cognitive function in people with Becker     dystrophy.      In muscular dystrophy, the cellular protein, dystrophin is affected. During normal     conditions, the enzyme neuronal nitric oxide synthase (nNOS), which produce nitric oxide     (NO), is attached to dystrophin. NO is important in normal vascular function in each of     muscle, heart and brain by stimulating production of cyclic GMP. However, in muscular     dystrophy with dystrophin deficiency, nNOS do not have the normal cellular anchor, resulting     in decreased NO levels and subsequent reduced cyclic GMP production. Sildenafil inhibits     degradation of cGMP thus prolonging and increasing a cGMP response. Such effects are the     basis for use of sildenafil in pulmonary hypertension and erectile dysfunction. Current     hypothesis: Sildenafil restores the cyclic GMP function affected in muscular dystrophy wit     nNOS deficiency resulting in improved muscle, cardiac, cerebrovascular and cognitive     function.   "
147763|NCT01350141|"     PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this     study to evaluate if it can lower LDL cholesterol.   "
147764|NCT01350128|"     The overall objective of this study is to determine an optimal dose and dosing regimen of     PT001 MDI for further evaluation in later stage studies.   "
147765|NCT01350115|"     This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial     evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult     patients with NBCCS. This was an exploratory study designed to demonstrate preliminary     efficacy of LDE225 in this indication. This study included a Screening period of     approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of     approximately 6-8 weeks followed by a long-term follow-up period.   "
147766|NCT01350102|"     The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic     wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health     Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will     be done to evaluate impact on time to wound closure.   "
147767|NCT01350089|"     The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks     has an effect on perceived alcohol intoxication.   "
147768|NCT01350076|"     The objectives of this study are 1) to investigate the influence of different fluid regimen     (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as     weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of     USCOM monitoring using serum lactate and base deficit as control parameters.   "
147770|NCT01350050|"     Topical Pharyngeal anesthesia (TPA) is widely used during upper endoscopy. Articaine is local     anaesthetic that have not been previously evaluated in pharyngeal anesthesia for upper     endoscopy. The aim of this study was to compare pharyngeal anesthesia with 4% articaine to     placebo (Na0,9%) during gastroscopy in terms of benefit on patients` and endoscopists`     satisfaction.   "
147771|NCT01350037|"     Self-administration of propofol and opioid mixture by the patient him- or herself     (patient-controlled sedation, PCS) could be successful alternative to the     anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography     (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of     this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.   "
147856|NCT01348932|"     The objective of this study was to investigate the relationship between single nucleotide     polymorphism of chitinase 3-like 1 and human asthma.   "
147772|NCT01350024|"     Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a     posterior approach. Patients who undergo this procedure are often given local anesthesia to     alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal     nerve block or subconjunctival injection combined with sedation in most cases. Both     techniques are currently acceptable options for local anesthesia, however postoperative pain     has not been systematically evaluated between these two techniques.      The investigators aim to compare intra-operative and postoperative pain with these two     techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will     be randomized to receive local anesthesia via frontal nerve block or via subconjunctival     injection. In addition, the investigators will measure the surgical outcomes of the ptosis     surgery with standard measures.   "
147773|NCT01350011|"     Drug addiction treatment patients, including those in treatment for opioid dependence, have a     high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates     an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid     treatment patients, those in buprenorphine maintenance. The specific aims of the study are to     test the efficacy and the cost effectiveness of the IS.      A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs     between participants who achieve abstinence from cigarettes during the study, and those who     do not.   "
147774|NCT01349998|"     The purpose of this study is to examine the long-term safety of treating recurrent episodes     of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or     tinea cruris for 7 days for each recurrence with Product 33525.   "
147775|NCT01349985|"     Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which     uses the text messaging and internet capabilities of modern cellular phones to address the     problem of medication adherence in clinical care and clinical trial contexts. This trial will     evaluate whether AGATE improves medication adherence in the context of a pharmacotherapy     trial of naltrexone to treat problem drinking. All participants will be treatment-seeking     problem drinkers who will receive naltrexone and medication monitoring over 8 weeks.   "
147776|NCT01349972|"     This randomized phase II trial is studying how alvocidib, cytarabine, and mitoxantrone     hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating patients     with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of cancer cells by     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as     cytarabine, mitoxantrone hydrochloride, and daunorubicin hydrochloride work in different ways     to stop the growth of cancer cells, either by killing the cells or by stopping them from     dividing. It is not yet known whether giving alvocidib, cytarabine, and mitoxantrone     hydrochloride is more effective than giving cytarabine and daunorubicin hydrochloride in     treating patients with acute myeloid leukemia.   "
147777|NCT01349959|"     This phase II trial studies how well giving azacitidine and entinostat work in treating     patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work     in different ways to stop the growth of tumor cells, either by killing the cells or by     stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some     of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill     more tumor cells.   "
147778|NCT01349946|"     Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study 2 (DEFUSE     2) is a multi-center pilot study to determine if cerebral perfusion imaging can help identify     which patients, who are ineligible for intravenous tissue plasminogen activator (iv tPA)     therapy or have failed iv tPA therapy, are most likely to benefit from an endovascular clot     removal procedure.   "
147779|NCT01349933|"     This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with     recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of     tumor cells by blocking some of the enzymes needed for cell growth.   "
147780|NCT01349920|"     This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy     with infliximab and determine whether changes in the levels of the selected biomarkers can be     used to predict endoscopically assessed gut mucosal status changes.   "
147781|NCT01349907|"     This study will investigate the safety and tolerability of a flexible dosing regimen of     asenapine for the long-term treatment of manic or mixed episodes associated with bipolar     disorder I in children and adolescents who completed study P06107.   "
147782|NCT01349894|"     The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System     for the treatment of skin cancer excision sites and split thickness skin grafts (STSG). The     secondary purpose will be to compare the prospective patients to retrospectively treated skin     cancer excision sites and STSGs to further evaluate efficacy and safety.   "
147783|NCT01349881|"     The investigators hypothesize that the combination of eflornithine and sulindac will be     effective in reducing a three-year event rate of adenomas and second primary colorectal     cancers in patients previously treated for Stages 0 through III colon cancer.   "
147784|NCT01349868|"     The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI     compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic     obstructive pulmonary disease (COPD).   "
147785|NCT01349855|"     Primary Objective:      To assess the safety and tolerability of two dose levels of a new insulin glargine     formulation in a once-daily multiple dosing regimen      Secondary Objective:      To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new     insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen   "
147786|NCT01349842|"     Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of     chemotherapy for metastatic breast cancer.   "
147787|NCT01349829|"     This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides     protection that is non-inferior to the protection afforded by vaccination with Havrix 720     Junior.   "
147788|NCT01349816|"     The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its     individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic     obstructive pulmonary disease (COPD).   "
147789|NCT01349803|"     This study is primarily a safety study. The primary and secondary endpoints are based on     24-hour Holter monitor assessments obtained on Day 14 relative to baseline.   "
147792|NCT01349764|"     When Vitamin D replacement is initiated in patients with history of urolithiasis, there will     be higher incidence of hypercalciuria but with careful follow-up of these patients,     hypercalciuria could be appropriately managed with thiazide diuretics so that the risk of     newly diagnosed renal stones will be equivalent to control groups without Vitamin D     replacements.the purpose of the study is to determine the effect of vitamin D replacement in     patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms     of changes in 24-hour urine collection parameters and to evaluate the lithogenic effect of     vitamin D replacement in terms of development of urolithiasis. Eighty-six eligible patients     will be included in terms of having suboptimal vitamin D with history of calcareous     urolithiasis and urinary calcium excretion <7.5 mmol/day. Patients will be randomly divided     into 2 equal groups depending on whether they will receive vitamin D replacement with     follow-up at 3, 6, 12, & 24 months.   "
147793|NCT01349751|"     The authors would like to investigate the blocking characteristics, surgical quality and side     effects of intrathecal levobupivacaine whether there are any differences between the     hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block     level than the urological surgeries.   "
147794|NCT01349738|"     The goal of this research program is to understand the natural history of asymptomatic     bacteriuria in the renal transplant patients, to determine if screening for asymptomatic     bacteriuria and identification of key host characteristics and virulence factors present on     uropathogenic bacteria identifies a sub-population of patients with asymptomatic bacteriuria     that are at risk to develop symptomatic urinary tract infection. Ultimately, the knowledge     obtained from this study will prevent inappropriate antibiotic use and may identify whether     certain bacterial isolates predispose to renal allograft injury. We will test the hypothesis     that (i) asymptomatic bacteriuria is common in the renal allograft recipient and (ii) that     symptomatic urinary tract infection and renal allograft dysfunction do not occur unless key     host susceptibility factors and uropathogenic bacterial virulence factors are present.   "
147795|NCT01349725|"     This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of     investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects     from the United States will be enrolled in this study.   "
147796|NCT01349712|"     The purpose of this study is to measure prothrombin time (PT) on an experimental device and a     commercially available device on persons receiving coumadin (warfarin)treatment.   "
147797|NCT01349699|"     Iron affects immunity. However, the exact effect of iron on the innate immune response is not     known. Animal data suggest that iron administration induced oxidative stress which enhances     the innate immune response, whereas iron chelation has the opposite effect. The investigators     tested the hypothesis that administration of iron sucrose 1.25 mg/kg augments the innate     immune response, and iron chelation by deferasirox 30 mg/kg attenuates the innate immune     response during human experimental endotoxemia.   "
147798|NCT01349686|"     Fasting during labour is a usual conduct in many hospitals around the world (due to the     theorical risk of bronchoaspiration). There is little evidence supporting this conclusion.     Besides, there are several studies that suggest that food intake during labour can be     associated with shorter labours and a lower cesarean rate. The aim of the investigators study     is to show if the oral intake of fluids during labour can reduce the first stage of labour     with minimum risk to the patient.   "
147799|NCT01349673|"     The purpose of this study is to evaluate safety and tolerability of cyclically dosed rectal     budesonide foam in subjects with active ulcerative proctitis (UP) or ulcerative     proctosigmoiditis (UPS).   "
147800|NCT01349660|"     In this phase I/II study,investigators are evaluating the feasibility and efficacy of the     combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of     patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120     dose to be administered with a standard dose of bevacizumab will be determined in patients     with refractory solid tumors. Although it is unlikely that the concurrent administration of     bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will     be performed on all patients treated during the Phase II portion of the study. Assuming this     combination is feasible, the Phase II portion of the study will proceed, using the doses     determined in the Phase I portion. In the phase II portion, eligible patients will be limited     to those with recurrent/progressive GBM following 1st line combined modality therapy.   "
147801|NCT01349647|"     Even when small cell lung cancer responds well to treatment with chemotherapy, it has a     tendency to grow back and to spread. The investigators are interested in testing new     therapies aimed at decreasing this risk. This study tests a vaccine, which is a substance     injected under the skin which can cause an immune response. The hope is that the body will     make antibodies to the vaccine which will also react against the cancer. The vaccine is     specific for small cell lung cancer. It combines several components (small cell lung cancer     targets) that have been tested individually in patients with small cell lung cancer or other     cancers (GD2, GD3, Globo H, Fucosyl GM1 and N-propionylated polysialic acid). Two other     substances (KLH and OPT-821) are added which boost the immune system.      This study will have two groups of patients. The first group will receive the vaccines along     with one cycle of chemotherapy. The second group will receive the vaccines without     chemotherapy.   "
147812|NCT01349504|"     Hypothesis:      Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory     Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in     patients with IBD. These factors can be identified using qualitative testing in order to     develop a validated instrument to measure the adherence profile of an individual patient,     and design appropriate behavioral interventions to reduce non-adherence.      Objectives:      To test a novel interview instrument that determines the medication adherence profile of     patients with IBD prescribed mesalamine by correlating with objective measures of adherence   "
147813|NCT01349491|"     The investigators hypothesize that ranolazine would decrease the incidence of recurrence of     Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with     persistent AF who are candidates for electrical cardioversion will be randomized to either     placebo or ranolazine after successful electrical cardioversion.   "
147857|NCT01348919|"     The primary objective of the study is to determine the maximum tolerated dose (MTD) of     CEP-18770 in combination with lenalidomide and dexamethasone in patients with relapsed or     refractory multiple myeloma.   "
147802|NCT01349634|"     Many school children in Ethiopia and their mothers are known to be iodine deficient.     Prevalence in the Amhara region is around 29%. Micronutrient Initiative, a development     organization based in Ottawa, plans to help iodize the salt by providing iodization machines     and iodine to the salt producers in Lake Afdira where salt is produced and distributed to the     population of Ethiopia. Although it is generally assumed that iodine is important for     cognitive development, very few studies examining the effects of iodized salt have been     conducted. Studies using a single dose of iodine capsules with children 6 to 12 years showed     mixed outcomes with approximately 25% yielding positive outcomes for the intervention     children. Sixty districts in Amhara will be randomly selected and randomly assigned so that     half receive early delivery of iodized salt. Approximately 6200 mothers and their children     6-, 18-, or 60-months old will be recruited from 1-2 villages in each of the 60 districts,     with the help of government-paid Health Extension Workers, for a 12-mo longitudinal study     starting in May 2011, prior to the introduction of iodized salt. These same mothers and     children will be visited 12 months later for repeated measures. Measures include nutritional     status such as height and hemoglobin, along with iodine sufficiency (e.g., goitre, urinary     iodine, thyroglobulin), and child development (Bayley Scales of Infant and Toddler     Development III, Wechsler Preschool and Primary School Intelligence test for older children).     Comparisons will be made within and between groups to determine whether iodized salt has an     effect on children's mental development.   "
147803|NCT01349621|"     This is a prospective study to compare unpolarized (conventional) to polarized light     colposcopy. Subjects will be asked to participate in the study when they arrive for their     prescheduled colposcopic examination. The study doctor will use a conventional or standard     colposcope to perform the examination. His/her impression of the exam will be noted and if     necessary a biopsy specimen will be obtained. The study doctor will then perform a colposcopy     using a polarized light. His/her impression of the exam will be noted and a biopsy specimen     will be obtained if necessary.      This study is designed to test the hypothesis that polarized light colposcopy is more     sensitive and more specific than standard, un-polarized light colposcopy.   "
147804|NCT01349608|"     This study is designed to explore a new approach to help people with chronic obstructive     pulmonary disease (COPD) become more physically active. Through weekly telephone sessions     with a health coach utilizing motivational interviewing, participants will be empowered to     set goals for increased physical activity (emphasis on walking). The objective of the study     is to determine if telephone-based health coaching is a reasonable and effective way to     increase physical activity, as measured by a gold-standard activity monitor, in people with     COPD.   "
147805|NCT01349595|"     The purpose of this study is to see if treating patients who have high levels of donor     specific alloantibodies post-transplant with bortezomib might prevent the development of     transplant glomerulopathy and preserve allograft function.   "
147806|NCT01349582|"     Flow diverters are a recent addition to the range of endovascular devices now available for     the treatment of intracranial aneurysms. The FIAT trial aims at comparing flow diversion to     best standard treatment in the context of a randomised controlled trial. Best standard     treatment may include any of the following and will be left to the treating physician to     decide : 1) conservative management; 2) coiling with or without high porosity stenting; 3)     parent vessel occlusion with or without bypass; 4) surgical clipping. If the only treatment     alternative is deemed to be flow diversion for compassionate use, then randomisation will not     be carried out, but patient will enter a registry and her data recorded according to same     schedule as randomised patients.      The primary hypothesis is that flow diversion can be performed with an acceptable immediate     complication rate, defined as less than 15% morbidity and mortality, AND increase the number     of patients experiencing successful therapy, defined as complete or near complete occlusion     of the aneurysm from 75 to 90%, relative to best standard treatment.   "
147807|NCT01349569|"     This research is being done to find out if the investigators can improve outcomes for     multiple myeloma patients by giving a myeloma vaccine to patients who are already on     lenalidomide (Revlimid) and in a near complete remission.   "
147808|NCT01349556|"     This research is being done to study whether using of topical tretinoin can help prevent the     common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I)     medications such ascetuximab or erlotinib.      Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their     face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and     topical or oral antibiotics. However, there has not yet been a study looking at a way to     prevent this common side effect from occurring, and topical tretinoin may be useful in     reducing the rash.      Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the     treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing     rashes associated with EGFR-I's.   "
147809|NCT01349543|"     The aim of this study is to understand the immune response (how the body fights infection) to     Respiratory Syncytial Virus (RSV). This virus usually causes a simple 'common cold' illness     in healthy adults, but can cause wheezing and lung problems in young infants and the elderly.     The investigators want to understand why this is, in order to develop vaccines and     treatments.      Participants will include 30-40 healthy adults age 18-55 years. Study procedures will include     brief medical exams, breathing tests, a diary of symptoms, blood tests, samples of fluid     (lavage) and cells from the nose, throat and lungs. All participants will receive the virus     via drops in the nose. The duration of the study for all subjects will be 6 weeks.   "
147810|NCT01349530|"     Main objective: To evaluate the impact of CREATIF (an anticoagulation clinic in Ile de     France) on monitoring and management of patients treated with VKAs compared with usual     primary care.      Study hypothesis: The investigators suppose that patients will have a better quality of     anticoagulation when they are managed by CREATIF than by their usual General Physicians (GP)   "
147811|NCT01349517|"     The purpose of this multi-center prospective cohort study is to study the health-related     quality of life (HRQL) together with other outcomes of patients with esophageal cancer after     surgery in China.   "
147814|NCT01349478|"     The purpose of this study is to determine whether a three times per week, 2 month robotic     assisted treadmill gait training program, will beneficially affect the fitness, physical and     psychological well-being, and the vascular and metabolic cardiovascular risk factors in     individuals with complete motor Spinal Cord Injury (SCI).   "
147818|NCT01349426|"     Surgical staplers have become standard for ligation, division, resection, anastomosis and     closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for     pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition,     closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally     safe and efficacious, staplers and staple loads are expensive, and can result in micro air     leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive     alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat     generated via bi-polar radiofrequency energy and precise jaw pressure to denature the     collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator     and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer     improved performance in terms of tissue sticking due to an improved sealing algorithm, and to     the jaw configuration of the Impact. The study main objective is to compare the quality of     parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with     LigaSure.   "
147819|NCT01349413|"     Background:      Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of     functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the     first line treatment for functional dyspepsia. However, the results on effectiveness of PPI     are conflicting and it has been suggested that PPI is only effective for acid-related     symptoms.      The investigators plan to use a wireless pH monitoring system positioned at the junction of     esophagus and stomach to evaluate the chronological relationship between acid exposure at     this region and symptoms of dyspepsia as well as its impact on the efficacy of acid     suppressive therapy in treatment of functional dyspepsia.      Indication:      Functional dyspepsia patients      Study center(s):      Prince of Wales Hospital, Hong Kong      Aims:        1. To evaluate the chronological relationship between acid exposure at squamo-columnar          junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia        2. To evaluate the relationship between acid exposure at squamo-columnar junction and          dyspeptic symptom response to PPI        3. To compare the efficacy of PPI and placebo in treating functional dyspepsia patients      Study medication:      Esomeprazole 20mg vs Placebo o.d.      Study design:      Double-blind randomized placebo-controlled trial      Number of subjects: 130      Patient population:      Functional dyspepsia patients without concomitant gastroesophageal reflux disease (GERD)      Duration of study:      1 June 2010 - 30 May 2012      Primary variable(s):      Proportion of patients who report positive response to adequate relief of dyspeptic symptoms     at week 8      Secondary variable(s):      Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation     to esophageal pH of less than 4 as measured at 1 cm above SCJ.      Number of visits: 2      Hypothesis:      Increased acid exposure at SCJ contributes to dyspeptic symptom and predicts treatment     response to PPI in FD patients without concomitant GERD   "
147820|NCT01349400|"     Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic     incisional hernias in terms of pain and discomfort during normal activities.   "
147821|NCT01349387|"     Main objective : Show that treatment with metformin in patients with type 2 diabetes has an     effect on alternative splicing of the insulin receptor.      Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with     discontinuation of treatment with metformin can be réversé by the resumption of metformin     treatment.   "
147822|NCT01349374|"     The main objective of this study is the Obtention of skin micro-samples collected from     healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to     obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.   "
147823|NCT01349361|"     Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however     the inconvenience of clinic attendance and discomfort during therapy are significant     drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of     BCC.   "
147824|NCT01349348|"     To evaluate the efficacy and safety of Tolvaptan 7.5mg and 15mg in treatment of patients with     cirrhosis ascites who fail to response adequately to treatment with common diuretics.   "
147825|NCT01349335|"     To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis     with ascites and exploring the dosage-effect relations of the drug.   "
147826|NCT01349322|"     RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as     effective as standard per daily radiation therapy in treating breast cancer.      PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per     daily radiation therapy with concomitant boost works compared to standard per daily radiation     therapy with a sequential boost in treating patients with early-stage breast cancer that was     removed by surgery.   "
147827|NCT01349309|"     The purpose of this study is to find out if doing prophylactic or preventative swallowing     exercises from the start of cancer treatment can improve the ability to swallow when the     treatment is completed and beyond.   "
147828|NCT01349296|"     BIBF1120 and RAD001 in solid tumors   "
147829|NCT01349283|"     The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to     the comparator vaccine both at impeding hepatitis B transmission from mothers positive for     chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in     children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion     of the immunization schedule.   "
147830|NCT01349270|"     Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a challenge because     disease may generate important disability in patients including young adults. Randomized     trials showed that corticosteroids, plasma exchanges and intravenous immunoglobulin (IVIg)     can reduce impairment on a short term period but the treatment of a chronic disease doesn't     agree with it. Corticosteroids and IVIg are the first line CIDP treatments. No study permits     to demonstrate the superiority of one treatment to the other. Long term adverse effects of     corticosteroids and IVIg cost are the respective limitation of their use. The investigators     scheduled to recruit 40 CIDP patients in 23 French centres to receive either 0,8mg/kg/day of     prednisone progressively tapered over 6 months or a monthly 2g/kg cure of IVIg during 6     months. Patients will be followed during 6 months after the treatment.   "
147831|NCT01349257|"     The aim of this clinical study is to compare the lung exposure of the contents of the trial     drug after administration of the fixed combination between beclomethasone and formoterol     delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and     formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device.     To determine lung exposure, the treatments are administered with charcoal block.   "
147832|NCT01349244|"     The purpose of this study is to determine the overall sensitivity and specificity of     hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to     hydronephrosis found by CT.   "
149589|NCT01326013|"     The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the     presence or absence of gastrointestinal (GI) pathogens from human stool specimens.      The objective of this study is to establish diagnostic accuracy of the xTAG GPP.   "
147833|NCT01349231|"     Roughly one-third of patients with obsessive-compulsive disorder (OCD) do not experience     significant clinical benefit from first-line interventions such as pharmacotherapy with     selective serotonin reuptake inhibitors (SSRI) or cognitive behavioral therapy (CBT).     Furthermore, OCD patients typically experience the full treatment benefits of first-line     interventions only after a time-lag of two to three months. Inadequate symptom relief and     delay of symptom relief from first-line treatments are sources of substantial morbidity and     decreased quality of life in OCD patients. Converging lines of evidence from neuroimaging,     genetic and pharmacological studies support the importance of glutamate abnormalities in the     pathogenesis of OCD.      The investigators are conducting an open, uncontrolled study of ketamine in     treatment-refractory OCD. Ketamine is a potent antagonist of the N-methyl-D-aspartate (NMDA)     receptor and has been demonstrated to have rapid anti-depressant effects in patients with     Major Depressive Disorder. The investigators have additionally provided evidence for rapid     improvement of comorbid OCD and trichotillomania after ketamine infusion in a depressed     woman.      Failure of symptom relief and delay of symptom relief from first-line treatments are a source     of substantial morbidity and decreased quality of life in OCD patients. Ketamine represents     the possibility to provide rapid symptom relief to OCD patients and may provide the mechanism     for future drug development to treat OCD more rapidly and effectively.   "
147834|NCT01349218|"     The purpose of this study is to find out whether there is a correlation (link) between the     level of potassium in blood samples drawn from a vein and those drawn from a heel stick in     infants scheduled for elective surgery.   "
147835|NCT01349205|"     The aim of this study is to evaluate whether a smaller dose of caffeine sodium benzoate 10     mg/kg IV is as effective as 20 mg/kg IV in decreasing the number of children who develop post     extubation adverse upper airway respiratory events compared to placebo.   "
147836|NCT01349192|"     Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant     Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in     2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing     this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung     infections in CF it is unclear how the onset of MRSA should be approached. This randomized,     controlled, interventional study seeks to determine if an early eradication protocol is     effective for eradication of MRSA and will provide an opportunity to obtain data regarding     early clinical impact of new isolation of MRSA.      Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory     culture on a routine clinic visit.      Procedures (methods): Randomized, open-label, multi-center study comparing use of an     eradication protocol to an observational group who receives the current standard of care i.e.     treatment for MRSA only with pulmonary exacerbations.   "
147837|NCT01349179|"     The couple of friction metal-polyethylene is regarded as the couple of reference in spite of     the osteolysis induced by the wear of the polyethylene which remains the independent factor     of long-term failure. This is all the more true as the patients are young, thus justifying     the recourse to alternate couples of friction. The Metasul® couple was introduced on the     French market under its current form in 1995 (year of its marking EC). The use of a couple of     friction metal-metal (MM) is justified because it would be likely to improve longevity of the     total arthroplasties of the active subjects by the reduction in osteolysis related to the     wear of polyethylene. Various studies highlight evolutions different according to the types     of fixing acetabular; favourable results of the not cemented cups contrasting with unsealings     and the evolutionary edgings of the Metasul® cups cemented of or the cups of cemented Weber     type.   "
147838|NCT01349166|"     The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity     and mortality associated with type 2 diabetes, it is imperative to propose methods of     prevention and this in early stage of abnormal glucose metabolism.      This study will assess the beneficial effects of physical activity (acute and chronic     effects) (the subjects being their own controls) on cardiometabolic and inflammatory     biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated     conditions: postprandial response to a standardized meal preceded or not by an exercise bout.      The investigators hypothesized that an acute bout of exercise will decrease the postprandial     inflammatory response to a standardized meal and that this effect of exercise will be     increased after 3 months of exercise training.   "
147839|NCT01349153|"     The purpose of this study is to determine the feasibility and efficacy of a behavioral     intervention, delivered through an existing social networking website (Facebook), on physical     activity (moderate-intensity minutes per week) among young adult cancer survivors compared to     a self-help education condition. For this research study, investigators will conduct a     12-week randomized trial. After a baseline survey, weekly messages, a pedometer, goal-setting     tool, physical activity log and discussion prompts will be delivered to the intervention     group. Comparison group participants will receive links to websites with self-help education     materials. After 12 weeks, a follow-up survey will be given to both groups. Changes in     physical activity, quality of life and psychosocial factors will be examined. The     investigators hypothesize that those receiving the intervention will have improved physical     activity behaviors at 12-week follow-up relative to those in the comparison group.   "
147840|NCT01349140|"     EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic     (numbing medicine) that is designed to be longer acting than the currently-available local     anesthetics. The purpose of this study is to determine the effect on thigh muscle strength     and skin sensitivity of various doses of EXPAREL when placed next to the nerve that goes to     the thigh.   "
147841|NCT01349127|"     This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg     cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to     assess vitamin D requirements in lactating women and to ascertain whether vitamin D     supplementation at levels sufficient to achieve defined thresholds of maternal serum     25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will also     report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and describe     the relationship between them. Information on maternal iPTH levels, anthropometry, diet and     sun exposure will also be reported.   "
147842|NCT01349114|"     The study will evaluate the effects of the direct renin inhibitor, aliskiren, on     flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic     patients with pre-hypertension or Stage 1 hypertension.   "
147844|NCT01349088|"     In 2008 there were more than 40,000 deaths caused by metastatic breast cancer in the United     States. The development of new treatment strategies is essential to improve outcome for     patients with metastatic breast cancer      There is significant preclinical and clinical evidence indicating that creating new blood     vessels (neoangiogenesis) to provide nutrients to solid tumors, including breast cancer,     provides the necessary conditions to allow tumor growth. Vascular endothelial growth factor     (VEGF) is one of the important molecules regulating new blood vessel formations and     subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial     interest for the treatment of advanced diseases.      This study will further the body of research of motesanib which has been shown in preclinical     pharmacology and clinical pharmacology studies to be a potent, orally bioavailable     multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively     targeting all known VEGF, platelet-derived growth factor (PDGF), and Kit receptors.   "
147845|NCT01349075|"     TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has     been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere),     it can be injected into the liver through a blood vessel. This allows a large local dose of     radiation to be delivered to the tumor with less risk of toxic effects from radiation to     other parts of the body or to healthy liver tissue.   "
147846|NCT01349062|"     This research work is important for the cure/control of HIV infection. The study is intended     to confirm the efficacy of Kallunk Oxide (Immunotherapy) molecules in the Treatment of HIV     infection. The study will investigate the T- Lymphocytes (immune) response to HIV in order to     boost the body's natural immune ability against infection. The basic study is directly     inhibit a protein's increased functions, not only in the CD4+T cell but also CD3+ and CD8+ T     cells and the CD45+. cells.      The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and     lifestyle can be more easily studied.   "
147847|NCT01349049|"     The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels     (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed     or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be     considered based on safety and efficacy observations.   "
147848|NCT01349036|"     The objective of this study is to evaluate the response of subjects with recurrent     glioblastoma to continuous therapy of PLX3397.   "
147849|NCT01349023|"     Pre-portioned entrées are commonly consumed to help control portion size and limit energy     intake. Few studies, however, have investigated the influence of the characteristics of     pre-portioned entrées on energy intake. This study investigates how the characteristics of     solid pre-portioned entrées, specifically, variations in their energy content and energy     density influence energy intake over a day. The investigators hypothesize that reducing the     energy content and energy density of compulsory entrées will act independently and add     together to reduce daily energy intake.   "
147850|NCT01349010|"     The purpose of this study is to evaluate the efficacy and safety of imported Probucol in     hyperlipidemia patients.   "
147851|NCT01348997|"     This study will develop and examine the effectiveness of an intervention that utilizes     technology to improve cancer survivors' access to mental health care and increase their     ability to manage the stressors involved in cancer survivorship. The intervention, referred     to as Project Onward, uses an interactive website and an online social network. The purpose     of this study is to pilot a novel intervention that can reduce costs, examine methods to     improve adherence to internet based treatment and overcome numerous barriers to treatment for     mental health concerns.   "
147852|NCT01348984|"     The purpose of this study is to determine whether transdermal fentanyl patch   "
147853|NCT01348971|"     The purpose of this study is to determine whether oral sodium nitrate administration prior to     coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition,     plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.   "
147854|NCT01348958|"     This study is to compare scans of the knee performed using new software designed specifically     to look at the knee joint with those performed using approved software designed for scans of     the hip.   "
147855|NCT01348945|"     Anterior cruciate ligament (ACL) is known to serve a number of functions in the knee joint.     Besides providing mechanical stability, it also contributes to proprioceptive function.     Numerous studies reported ACL is rich in mechanoreceptors contribute in proprioceptive     function. ACL augmentation, or selective ACL bundle (AM, anteromedial or PL, posterolateral)     reconstruction, a relatively new technique for partial torn ACL, preserves and augments the     ACL remnant aiming at maintaining or facilitating proprioception, is now gaining its     popularity. Preserving ACL stump is also reported to have merits in providing better     mechanical protection and promoting revascularization to the newly reconstructed graft.      In local setting, stump preserving ACL surgery is the usual practice in handling partial ACL     tear. With the background of the surgery's potential benefits in restoration of knee     function, a single-blinded, comparative study on the difference in proprioception, postural     stability and clinical outcome between stump preserving ACL surgery and reconstruction is     conducted.   "
147858|NCT01348906|"     This study aims to determine the effect of intermittent normoxic cardiopulmonary bypass (CPB)     on inflammatory response, oxidative stress and myocardial reperfusion injury in adult     patients undergoing valve replacement. The investigators hypothesized that nuclear factor     kappa B (NFkB) was involved in regulating gene expression of myocardial inflammatory factor.   "
147859|NCT01348893|"     The purpose of this preliminary study is to evaluate the effects of a yoga-based program on     high school students' psychological health. Results will be used to generate specific     hypotheses of how yoga may improve adolescent mental health.   "
147880|NCT01348607|"     RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and     improve the quality of life of patients with excessive daytime sleepiness after cancer     therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more     effective than a placebo in reducing daytime sleepiness in these patients.      PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or     modafinil to see how well they work compared with a placebo in treating young patients with     excessive daytime sleepiness after cancer therapy.   "
147860|NCT01348880|"     The study will be conducted as a multi-center, randomized, double-blinded, placebo     controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating     Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT     during Period 1 or 2; the blinded matching placebo will be given as a single administration     during the opposing period. The random code will determine the order of active drug     (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be     recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non     investigational drug product (vasodilator), Procardia XL, will be background treatment for     hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for     at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the     requirement that all subjects will be male, are between the ages of 65 and 80 years, and will     have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size     will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this     analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the     ages of 70 and 80 years. The total duration of the study will be approximately one year from     first subject treated to last subject treated, including replacement of any subjects who fail     to complete both periods of crossover dosing.   "
147861|NCT01348867|"     The investigators hypothesize a diabetes nurse consultant led team with particular emphasis     on compliance and attainment of treatment targets in Type 2 diabetic patients will achieve     metabolic control, improve clinical outcomes and levels of self efficacy compared to usual     clinic-based care.   "
147862|NCT01348854|"     To determine if arcuate incisions performed with the iFS femtosecond laser are safe and     effective in reducing corneal astigmatism.   "
147863|NCT01348841|"     Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in     the community for most of these is coordinated by the local Community Care Access Centre     (CCAC). One or more health professionals might deliver treatment, individually or as part of     a wound care team, with different members having different kinds of training     (interdisciplinary team), which may or may not include wound care. Community treatment by     interdisciplinary teams has been shown to be more effective and cost-effective for some     long-standing health problems, but further scientific evidence is needed to determine if this     is also true for chronic wounds.      This study compares the usual way chronic wounds are being managed in the community with a     so-called intermediate care approach. In this study, intermediate care will involve health     service providers following certain agreed-upon steps (evidence-based best practice) from     first contact with the client through assessment, treatment, and on to referral to a hospital     specialty wound care team, if needed.   "
147864|NCT01348828|"     The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated     Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.   "
147865|NCT01348802|"     Pain is a problem for many Canadians. Unfortunately, many doctors, nurses, therapists, and     psychologists have trouble keeping up to date and applying the latest research that might     help patients suffering with pain. This study will determine whether sending alerts about new     pain research directly to these health professionals, and providing them with access to     accumulated alerts, will help. The study will compare knowledge and decisions made by health     professionals about managing pain problems. The investigators will compare physicians,     nurses, rehab therapists and psychologists at the beginning of the study and after having     access to different ways to find out about new pain research. One group will receive alerts     about new pain studies that have been found to be high quality and relevant to patient care,     and will be able to search the alerts database. The other group will be able to find the same     studies,but must go to the database of research studies to locate them. The investigators     will include 670 doctors, nurses, rehab therapists, and psychologists in this study. A     process like tossing a coin will determine which way they are able to get pain research     information. The investigators will monitor how much information they access and how they     apply it to managing pain problems. The investigators expect that reminding health care     providers about new research findings directly will help them, since difficulty finding     studies and lack of time prevent them from using the latest research. The investigators     expect that reminders about the latest research will help them make better decisions about     caring for patients' pain.   "
147866|NCT01348789|"     To measure the safety of hair removal device when used frequently.   "
147867|NCT01348776|"     The purpose of this study is to determine efficiency of Hair2Go device for short-term and     long-term removal of unwanted hair adjunctive to shaving using a before-after study design.   "
147878|NCT01348633|"     Canadians fear loss of vision more than any other disability. Vision loss has an enormous     impact on quality-of-life and is extremely costly from a societal and economic perspective.     In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting     for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by     65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial     cost of vision loss in Canada is $15.8 billion per year. There is a general perception that     vision loss is normal with aging but 75% of vision loss is estimated to be preventable. The     major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma,     particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is     headed for an epidemic of age-related eye disease and, unless something is done to prepare     for this, severe vision loss will have significant consequences in terms of societal and     economic costs. Through this proposed Research Program, and in conjunction with our     international academic and private sector partners, we will build and develop unique     quantitative imaging technologies to permit non-invasive assessment of visual changes,     structural changes in the thickness of the retina at the back of the eye and also changes in     the amount of blood flowing through the blood vessels that feed the retina with oxygen. This     research will add to our basic knowledge in predicting the development of sight-threatening     change in patients with the three diseases, and facilitate earlier detection of the problem     to help us discover earlier treatments for people with these conditions. The reliability of     each imaging technology will be assessed by determining its ability to differentiate between     diseased and healthy eyes. Cross-sectional analyses at yearly intervals, as well as change     over time analyses, will be undertaken.   "
147915|NCT01348152|"     The primary objective of this study is to evaluate the improvement in the severity of     constipation (from Baseline to Day 28), determined by the constipation severity instrument     (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100     administered for 28 consecutive days in adult subjects with functional constipation.   "
149622|NCT01325584|"     The purposes of this study are to make Omegaven® available to cancer patients with liver     disease and to determine if Omegaven® can improve or prevent further liver disease. The study     will also look at the effects Omegaven® has on immune function.   "
147868|NCT01348763|"     This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects     currently attending for HIV care at St. Mary's Hospital, London will be eligible.      The study will describe the steady state pharmacokinetic parameters and short term safety of     maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without     tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.      Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be     receiving antiretroviral therapy comprising:        -  tenofovir/emtricitabine 245/200 mg daily plus        -  darunavir/ritonavir 800/100 mg daily      On day 1, subjects will modify their current antiretroviral therapy to the following:        -  tenofovir/emtricitabine 245/200 mg daily plus        -  darunavir/ritonavir 800/100 mg daily plus        -  maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic          visit.      On day 11, subjects will modify their current antiretroviral therapy to the following:        -  darunavir/ritonavir 800/100 mg daily plus        -  maraviroc 150 mg daily (i.e. tenofovir/emtricitabine will be discontinued) On day 20          subjects will undergo an intensive pharmacokinetic visit. Following completion of this          study phase, subjects will recommence their usual antiretroviral treatment regimen and          attend for a study follow up visit.   "
147869|NCT01348750|"     This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a     complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces     Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in     returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims     will evaluate the effect of HT and GI on measures of depression, hostility, and general     health status in this population.   "
147870|NCT01348737|"     The purpose of the study is to assess the safety, tolerability and blood concentration of     AZD3839 following oral administration of single doses in healthy men and women of     non-childbearing potential   "
147871|NCT01348724|"     Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a     Single-Dose Oral Administration.   "
147872|NCT01348711|"     To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination     in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of     gestation   "
147873|NCT01348698|"     Background:      - Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are     no tests that can accurately tell which adrenal tumors are cancerous and which are not. The     only way to tell is to remove the tumor with surgery and then examine it. Researchers have     been using new methods to study samples of adrenal tissue. These methods may help identify     whether the cells are or may become cancerous without an operation. This information will     help doctors determine which tumors will need to be removed.      Objectives:      - To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods     that may help identify cancerous or precancerous cells.      Eligibility:      - Individuals at least 18 years of age who have an adrenal tumor that may or may not be     cancerous.      Design:        -  Participants will be screened with a physical examination, medical history, blood and          urine tests, and imaging studies.        -  Participants will be examined to determine whether they have a specific type of adrenal          tumor      (pheochromocytoma).        -  Participants whose tumor does not secrete hormones will have a tumor biopsy to collect          tissue for study.        -  Participants who have a large tumor or one that secretes hormones will have standard          surgery to remove the tumor. Tissue will be collected for study.        -  Researchers will examine the collected tissue. They will try to determine whether the          cells are cancerous or may become cancerous.        -  Participants will be asked to return to the National Institutes of Health Clinical          Center every year for about 5 years. During these visits they will have imaging studies,          lab tests, and a physical examination....   "
147874|NCT01348685|"     To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its     component mixtures and whey protein on subjective appetite and food intake in young men.   "
147875|NCT01348672|"     Canadians fear loss of vision more than any other disability. Vision loss has an enormous     impact on quality-of-life and is extremely costly from a societal and economic perspective.     In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting     for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by     65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial     cost of vision loss in Canada is $15.8 billion per year. There is a general perception that     vision loss is normal with aging but 75% of vision loss is estimated to be preventable. The     major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma,     particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is     headed for an epidemic of age-related eye disease and, unless something is done to prepare     for this, severe vision loss will have significant consequences in terms of societal and     economic costs. Through this proposed Research Program, and in conjunction with the     investigators international academic and private sector partners, the investigators will     build and develop unique quantitative imaging technologies to permit non-invasive assessment     of visual changes, structural changes in the thickness of the retina at the back of the eye     and also changes in the amount of blood flowing through the blood vessels that feed the     retina with oxygen. This research will add to the investigators basic knowledge in predicting     the development of sight-threatening change in patients with the three diseases, and     facilitate earlier detection of the problem to help us discover earlier treatments for people     with these conditions. The reliability of each imaging technology will be assessed by     determining its ability to differentiate between diseased and healthy eyes. Cross-sectional     analyses at yearly intervals, as well as change over time analyses, will be undertaken.   "
147876|NCT01348659|"     The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch     solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass     grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir of     the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight and     extracellular water from baseline to the first postoperative morning.   "
147877|NCT01348646|"     The purpose of this study was to see whether a brief intervention given in adolescence has an     effect on smoking in adulthood. The investigators also wanted to clarify the significance of     some known psychosocial risk factors of smoking in adulthood.   "
147879|NCT01348620|"     This is a single-institution, prospective, randomized controlled trial. Subjects determined     to need a cholecystectomy will be consented for surgery and study participation prior to     enrollment in this study. Patients will then be randomized to receive either a single port     laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.   "
149623|NCT01325571|"     To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis     who are inadequately treated by glucocorticoid.   "
147881|NCT01348594|"     Infertility is a common and psychologically devastating problem for 20% of Canadian couples.     Approximately, 20% of infertile couples are diagnosed with unexplained infertility and left     without an explanation for their inability to have a baby. Pathological uterine receptivity     and embryo implantation are hypothesized mechanisms underlying sub-fertility in these     couples. Embryo implantation requires a complicated sequence of events involving the     differentiation of endometrial cells to attain uterine receptivity and the synchronized     interaction between maternal and embryonic tissues. Vitamin D has been hypothesized to play a     role in this poorly understood process. Vitamin D is a known regulator of signal transduction     pathways involved in embryo implantation and its receptors are involved in calcium-regulation     in various reproductive tissues including, the ovary, uterus, and placenta. In Canada, the     prevalence of Vitamin D insufficiency is approximately 34-50%. The goal of the proposed study     is to determine the prevalence of vitamin D insufficiency in an infertile population and     whether this prevalence is higher than in average Canadian reproductive age women. More     importantly, we will investigate whether vitamin D insufficiency in our infertile population     translates to impaired implantation and reduced clinical pregnancy rates. Insight into     vitamin D's role in reproduction is essential not only to provide scientific understanding of     the mechanism underlying embryo implantation, but also because vitamin D supplementation     could provide an easy and safe means of treating infertility.   "
147882|NCT01348581|"     The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of     fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.      The wound dressing is indicated for the management of difficult to heal and chronic wounds.     The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary     dressing is put on top. Further dressing of the wound depends on the etiology.      The indications for use are:        -  partial and full-thickness wounds        -  pressure ulcers        -  venous ulcers        -  diabetic ulcers        -  chronic vascular ulcers        -  tunneled/undermined wounds        -  trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)   "
147883|NCT01348568|"     Healthy individuals with type 2 diabetes will receive intensive counseling on food selection     to improve glucose control using either high cereal fiber dietary strategies or low glycemic     index foods especially canola oil containing bread. The treatments will last 3 months with     bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or     both diets, then use of high fiber, and/or low glycemic index foods with canola oil, may     provide another potential way to improve glucose control and lower cholesterol levels in     non-insulin dependent diabetes.   "
147884|NCT01348555|"     Pulmonary administered anticholinergic agents have shown their importance in the chronic     obstructive pulmonary disease (COPD) management to reduce morbidity, disability and     mortality. To date, the recommended treatment of moderate to severe COPD patients consist in     the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a     medical need in new product that could exhibit both anti-inflammatory and strong     bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.      Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound     and could bring new option in the treatment of this life-threatening disease.   "
147885|NCT01348542|"     The purpose of this study is to evaluate the effect of a 3 month medication trial of     Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic     insomnia.   "
147886|NCT01348529|"     The main aim of this study is to test whether cognitive behavior therapy could be effective     in treating obsessive compulsive disorder. Here, the investigators test the in group effects     of a 15 week long treatment delivered via the Internet for residents in Stockholm County.   "
147887|NCT01348516|"     The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after     single/multiple dosing.   "
147888|NCT01348503|"     The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and     Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with     surgery.   "
147889|NCT01348490|"     To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms     and potential side effects in patients with PMF, PPV-MF and PET-MF who have platelet counts     of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose optimization from     the starting ruxolitinib level of 5 mg bid will be associated with reductions in     splenomegaly, MF-associated symptoms and inflammatory cytokine levels.   "
147890|NCT01348477|"     The investigators describe a new surgical technique for inguinal hernia open repair, which     will be compared with the Lichtenstein technique. The investigators seek to find the     difference between the two techniques in postoperative pain.   "
147891|NCT01348464|"     The aim of this study is to compare patients who undergone single-port access laparoscopic     appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA)     in a prospective randomized trial   "
147892|NCT01348451|"     This is a first-in-human trial of spinal derived stem cells transplanted into the spinal cord     of patients with Amyotrophic Lateral Sclerosis (ALS). The goal of the study is to see if the     cells and the procedure to transplant them are safe.   "
147893|NCT01348438|"     The purpose of the study is to evaluate the safety and clinical performance of the Engager     Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis     who are at high risk for surgical valve replacement.   "
147894|NCT01348425|"     This randomized, post-market clinical study is intended to evaluate the delivery and     deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80     mm) for treatment of lesions of the above-the-knee femoropopliteal artery.   "
147916|NCT01348139|"     The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single     doses of three different dry powder inhalation formulations of AZD3199 administered via     Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and     compared to placebo in patients with persistent asthma.   "
147917|NCT01348126|"     The purpose of this study is to determine whether combining ganetespib (STA-9090) with     docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced     non-small cell lung cancer.   "
147895|NCT01348412|"     Standard treatment of metastatic colorectal cancers relies on fluoropyrimidines, irinotecan     alone or in association with fluoropyrimidines, oxaliplatin in association with     fluoropyrimidines, bevacizumab and anti EGFR antibodies. After failure of classical regimen     the national reference frame on the basis of phase II study proposes an association of     fluoropyrimidine and mitomycin. These treatments give response rates of 10-20% with     progression free survivals from 2 to 3 months. Hepatic intra-arterial chemotherapy is logical     in the case of isolated hepatic metastases nonaccessible to curative resection: 1) hepatic     metastases are vascularized by hepatic arterial system in contrast to nontumoral hepatic     parenchyma; 2) arterial perfusion of oxaliplatin leads to a strong extraction by the liver     during the first passage, a high intra-tumoral concentration and a low systemic     concentration. So oxaliplatin is a drug of choice for arterial treatment but combination with     fluoropyrimidines is impossible because of need for prolonged perfusion. Floxuridin is not     available in France. Raltitrexed, a definitive inhibitor of the thymidylate synthase, does     not require a prolonged perfusion and could be a good substitute.In a previous pilot study we     demonstrated the feasibility, safety and efficacy of combination of raltitrexed and     oxaliplatin arterial perfusion. Now we propose a phase II randomized clinical trial to     evaluate the efficacy of hepatic arterial infusion of raltitrexed and oxaliplatin association     versus standard chemotherapy for patients with metastases of colorectal origin restricted to     the liver after failure of conventional chemotherapy.   "
147896|NCT01348399|"     The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in     the real world daily practice as compared with other drug eluting stents (DESs)   "
147897|NCT01348386|"     BACKGROUND:      Molluscum contagiosum is a non-serious children viral infection. Because of its natural     history, being highly contagious and the aesthetic and psychotherapeutic effects of its     treatment, the investigators intend to test the use of different concentrations of potassium     hydroxide solution in the primary care setting.      METHODS:      A double blind, randomized clinical trial, in three groups of topic treatment is designed.     The intended treatment consists on a daily application of potassium hydroxide in aqueous     solution at 10% and 15% concentration, versus a placebo administered to the control group. 4     follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and     tolerance.      The main target of the trial is to determine the healing rate, defined as lesion     disappearance in the affected zones after the topic application of the treatment. Secondary     targets are the main characteristics and evolution of the affected zone (surface, number of     lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching,     burning, pain), recurrence rate estimation and natural evolution of lesions in the control     group.   "
147898|NCT01348373|"     The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated     stent in patients with STEMI with other drug-eluting stents (DESs).   "
147899|NCT01348360|"     The objective of this study is to evaluate effectiveness and safety of Nobori stent in the     real world daily practice as compared with first-generation drug-eluting stents (sirolimus-     or paclitaxel-eluting stents).   "
147900|NCT01348347|"     This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib in     Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose     (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1     (Plk1) inhibitor in advanced cancer patients.   "
147901|NCT01348334|"     The purpose of this study is to determine the clinical results contributions to surgical     success,and complications of mixed type of mesh materials as well as prolen mesh materials in     sling surgery in a 3 year follow-up the first time in literature.   "
147902|NCT01348321|"     Different immunologic mechanisms contribute to development of inflammation in acne vulgaris     and immunologic effect of levamisole has been demonstrated.      Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin     alone in the treatment of acne vulgaris.   "
147903|NCT01348308|"     The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a     combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients     counts may accelerate the kinetics of immune restoration and decrease the risk of disease     progression and death.      It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.   "
147904|NCT01348295|"     This observational study includes questionnaires send to doctors in all units treating     pediatric patients with mechanical ventilation in Finland. Additionally all units treating     pediatric patients with mechanical ventilation are invited to perform a quality control-like     follow up for 3 months. Patient identity data is not collected, and no interventions to     treatment are made.   "
147905|NCT01348282|"     The current project proposes the comparison of two pharmacologic strategies as adjunctive     treatments for the improvement of HIV-associated neurocognitive disruption, additionally to     use of HAART. The investigators propose the use of the compound that has shown greatest     benefits in this context to date, the lithium, versus the use of a well-tolerated and     promising drug in other pathologies with neurocognitive affectation, such as Alzheimer or     Parkinson diseases, which is the rivastigmine. In those other diseases, this second compound     has recently offered a good tolerability, but also benefits on attention, memory and other     neurocognitive areas. Both study groups, patients on therapy with lithium and patients on     therapy with rivastigmine, will be compared to a control group, which will not initiate any     other treatment (therefore only continuing antiretroviral therapy). The investigators are     aware that this proposal will offer new relevant data for the study of neurocognitive     improvement in HIV infection, as well will allow a better knowledge of clinical management of     HIV-infected patients with CNS disease, an aspect that is a common clinical concern today.   "
147906|NCT01348269|"     The primary aim is to test the reduction of bone marrow edema syndrome after a singular     intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of     the edema is defined as biometric data measured by the use of MRT before and six weeks after     treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the     treatment of painful bone marrow edema. A statistically significant reduction of the edema in     the MRT is considered as evidence for efficacy.   "
147908|NCT01348243|"     Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis.      The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at     least as effective as daily oral therapy and appears more effective than intermittent     intravenous treatment. Intramuscular clodronic acid in particular has also been associated     with improvements in back pain. The drug is well tolerated, with no deleterious effects on     bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal     adverse effects that may be seen in patients receiving oral bisphosphonates therapy.      In order to simplify the therapeutic dosing regimen, reducing the number of administrations     per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new     formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has     been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at the     same concentration as in the 100 mg clodronic acid formulation.      The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200     mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy     post-menopausal volunteers. Two formulations were similar in terms of amount and rate of     clodronic acid urinary excretion and in terms of safety profile.   "
147909|NCT01348230|"     When babies are premature, or born before they are fully developed, they face many different     medical problems, some of which are quite devastating, such as cerebral palsy, mental     retardation, blindness, deafness, severe intestinal problems, and developmental delays.     Unfortunately, in more than half the cases of premature births, there is no procedure or test     that an obstetrician can employ to predict if a fetus is at risk for premature birth,     especially when the mother is healthy. This study seeks to determine if certain factors found     in the urine undergo specific changes that can be used to detect premature births of this     type before they happen.   "
147910|NCT01348217|"     Exclusive concomitant radiochemotherapy (RCT) at a dose of 50 Gy delivered over 5 weeks,     according to the RTOG 85-01 protocol, has led to improved 5-year survival in 25% of patients,     whereas no patients survived for 5 years using radiotherapy alone for patients with     esophageal cancer. Surgery, even when combined with preoperative RCT, also gives     disappointing results for locally advanced tumors, which casts serious doubts on the     usefulness of preoperative radiotherapy. By varying the fractionation schedule, the length of     treatment or the radiotherapy volumes, it has become possible to obtain levels of     loco-regional relapse of around 35 to 45%. After reviewing the results for loco-regional     relapse according to the dose of radiation and the recommended radiotherapy volumes, we aimed     to investigate why increasing the dose of radiation has no impact in esophageal cancers.     Although INT-0123 phase III trial showed no benefit of dose escalation in esophageal cancer,     some issues remain unclear as most of the patients who died in the experimental arm were     treated above 50Gy. Moreover, only the tumor was treated up to 64Gy while involved nodes were     not considered for dose escalation in this trial. In the RTOG 85-01phase III trial, an     elective nodal irradiation from subclavicular fossa up to the esophagogastric junction was     performed with a 2D technique, delivering 30Gy which could be considered as not appropriate.      In this randomized phase II/III trial, we aim to test an exclusive concomitant     chemoradiotherapy for patients with non resectable esophageal cancer with a dose escalation     up to 66Gy on the primary tumor as well as the involved nodes using a 3D conformal technique     combined with a 40 Gy elective nodal irradiation on lymph node stations (as defined by the     RTOG) with a risk of microscopic involvement ≥ 20%.   "
147911|NCT01348204|"     The purpose of the study is to develop new biomarkers for studies of cystic fibrosis (CF).     Defects in the gene encoding Cystic Fibrosis Transmembrane Regulator (CFTR) cause CF, an     autosomal recessive disorder affecting mainly the pulmonary and digestive tract, leading to     early death largely due to progressive loss of pulmonary function. In vitro experiments show     that quercetin - a dietary supplement with a well-established safety profile for human use,     including clinical trials in a variety of disorders encompassing cancer, heart disease, and     as an anti-inflammatory agent - induces activation of CFTR. The nasal potential difference     (NPD) test is a measurement of voltage across the nasal membrane and as a fundamental     biomarker for CFTR activity in vivo. The NPD is a useful, well-established tool in CF     research to determine both diagnoses as well as to measure the effect of new therapies. In     vitro experiments show that quercetin induces activation of CFTR additive to that seen with     current NPD reagents. In addition, it activates rescued mutant CFTR in vitro (∆F508 CFTR the     most common cause of CF), whereas conventional agonists do not. Preliminary in vivo     experiments mirrored these results and show that quercetin activates CFTR in human (n=12) NPD     tests. Importantly, quercetin perfusion was well-tolerated by a validated sinus questionnaire     and physician assessed nasal examination rating. These studies provide strong support for use     of quercetin as potentiator of CFTR Cl- channel function by nasal administration. By adding     quercetin to the sequence of perfusion solutions for NPD, the investigators may be better     suited to detect ∆F508 CFTR activity of rescued mutant protein in the CF patient population.   "
147912|NCT01348191|"     It has been recognized for many decades that high thyrotrophin (TSH) levels in pregnant women     are associated with poor obstetric outcome. Also, there is evidence that high TSH is related     to fetal position at term, including breech which in turn is associated with obstetric     complications.      However, the mechanism behind remains to be elucidated.      The current project is of basic-fundamental nature. It is used to better understand basis     physiological processes. As in many other studies of similar basic nature, few numbers are     always included.      If a TSH receptor will be detected, future randomized controlled trials (RCT) might be     worthwhile with large numbers of women who will be treated with thyroxine to possibly prevent     abnormal fetal position during normal pregnancy.      The aim of the current study is to evaluate whether a TSH receptor can be demonstrated in     human myometrium. If so, the pathophysiology of high TSH in relation to obstetric outcome     will become more clear. Furthermore, the aim is to test the myometrium in vitro for its     relaxation and contractility and for the conductance of electropotentials.   "
147913|NCT01348178|"     This is a retrospective study assessing pre- and postoperative radiographic indices of hip     dysplasia in order to identify factors predicting failure following Periacetabular Osteotomy     (PAO).   "
147914|NCT01348165|"     Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy     Male Volunteers   "
147918|NCT01348113|"     Excessive alcohol consumption is a worldwide major public health problem. Brief interventions     have shown to be an efficient treatment modality for problem drinkers, but have never been     tested in scheduled surgery.      Patients will be recruited in various surgery units in 7 hospital in France. All patients     attending a scheduled surgery will be screened during the visit with the anaesthesist by the     Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between     7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study     and randomized between a brief intervention by a trained nurse during the post-surgery     hospitalisation and no intervention. Twelve months after the surgery, a research technician     will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last     month.   "
147919|NCT01348100|"     This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation     of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in     support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the     safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and     safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected     for assessment in Phase C. Phase C of this study is designed to define the dose-exposure     relationship of the selected form and to provide information that will permit a comparison of     the risk-benefit ratio of several doses of the study drug to enable optimal dose selection     for later studies.   "
147920|NCT01348087|"     The purpose of this study is to generate long-term safety, tolerability and efficacy data for     AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212     (NCT01253629).study and patients who have participated in the previous proof-of-concept study     CAFQ056A2204 (NCT00718341).   "
147921|NCT01348074|"     It is not known how to best restart warfarin after temporary withdrawal. Participants will be     randomized to two groups. Group 1 will restart warfarin at their usual maintenance dose,     group 2 will restart warfarin at double their maintenance dose for two days followed by their     usual maintenance dose. The main outcome parameter will be the number of patients who are     back in therapeutic INR (international normalized ratio) range 4, and 9 days after restarting     anticoagulation with warfarin. Thromboembolic and/or bleeding events will be recorded as     additional parameters. These data will be collected by a standardized telephone interview at     1 month. In addition, the investigators will evaluate a possible prothrombotic state by     measuring the potential of thrombin generation and D-dimers in the subset of patients     visiting HHS-General Hospital for their INR tests.   "
147922|NCT01348061|"     This is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF)     biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP)     compared to healthy controls using a heavy water (2H2O) labeling method. This study is     exploring the time profile of appearance and disappearance of pulse deuterium-labeled cargo     proteins in CSF of subjects with AD and/or PSP, which is different from healthy controls, due     to deficits in fast axonal transport.   "
147923|NCT01348048|"     Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in     patients with a life threatening disease such as advanced cancer. Many patients with advanced     cancer are not in contact with SPC. Previous studies have shown that among advanced cancer     patients not referred to SPC there is a significant prevalence of symptoms, problems and     needs. The aims of the present study are to investigate whether patients with metastatic     cancer, who report palliative needs in a screening, will benefit from being referred to SPC     and to investigate the economical consequences of such a referral.   "
147924|NCT01348035|"     Increased water intake slows autosomal dominant polycystic kidney disease (ADPKD) progression     in animal models, but clinical implication is unknown. Encouraged water intake in patients     with ADPKD for one year resulted in accelerated kidney enlargement and functional     deterioration. Increased urine sodium and/or unknown factors concurrent with increased urine     volume might stimulate disease progression more strongly than decrease in plasma vasopressin     ameliorated it.   "
147925|NCT01348022|"     This study is a multicenter, open label, prospective, single arm trial      Single arm group; following angiography, eligible patients with unprotected LMCA stenosis     >50% by visual estimation, which is equally treatable by the both treatment strategy (EES     stenting or CABG), will be treated with EES   "
147926|NCT01348009|"     Cisplatin, an intravenously administered platinum agent, in combination with an intravenously     administered taxane and capecitabine has been shown to improve time to disease progression     and overall survival in previously untreated patients with gastric cancer.      This study is being performed to evaluate an orally administered taxane (tesetaxel) in     combination with cisplatin and capecitabine in previously untreated patients with gastric     cancer.   "
147927|NCT01347996|"     Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia     Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This     is an international, multicenter, open-label study to evaluate the effects of remission     maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune     system cells (T and NK cells) and prospectively defined markers of immune response that are     known to reflect T and NK cell ability to combat AML.   "
147928|NCT01347983|"     24 week open-labeled extension study to continue monitoring the same group of patients in the     previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of     tocilizumab.   "
147929|NCT01347970|"     This randomized phase II trial studies the side effects and how well low-dose carvedilol     works in preventing congestive heart failure (CHF) in younger cancer survivors exposed to     high dose anthracyclines for management of childhood cancer. Carvedilol may help lower the     risk of cardiovascular complications   "
147930|NCT01347957|"     Preclinical studies showed the Nitric Oxide (NO) gel significantly promoted hair follicle     formation and growth in both rat and mouse models. The NO gel induced major physiological,     developmental, and structural changes in the skin of mammals to increase the number of hair     follicles, follicle stem cell development and regeneration as well as hair shaft elongation,     and accelerated hair growth rate. Based on our animal model findings, the investigators     hypothesize that the nitric oxide releasing gel could be used as a medical treatment for hair     growth in humans. The objective of this trial is to evaluate the safety and efficacy of this     NO gel (XN-001), in comparison with a placebo gel in subjects in a 24-week treatment     schedule.   "
147931|NCT01347944|"     The purpose of this study is to collect clinical and laboratory data for patients affected by     intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were     prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these     patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA)     issued according to a National law named 648/96.   "
147932|NCT01347931|"     The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic     respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system     will accomplish this by providing oxygen under pressure and augmenting the subject's     spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted     ventilation, and a comfortable low-profile device, will result in a mean improvement in     perceived well-being and ability to perform ADLs, as measured by patient-reported outcome     (PRO) instruments.   "
147933|NCT01347918|"     The aim of this project is to demonstrate and validate the ionizing radiation free and non     invasive assessment of small intestinal anatomy, content and function in healthy and disease     by a newly developed combined proton (1H) and fluorine (19F) magnetic resonance imaging (MRI)     framework. Meal induced and pathology related alterations in small intestinal motor activity,     gas distribution and anatomy of healthy volunteers and patients with irritable bowel syndrome     (IBS) will be analyzed with this non invasive MRI approach.      The multinuclear imaging framework consists of a 1H and 19F capable clinical 3T MRI system     with standard 1H abdominal surface coils, a dual-channel transmit-receive abdominal 19F     surface coil, fluorine labelled impermeable and biocompatible capsules for oral     administration (19F capsule) and a 19F projection imaging sequence allowing for the     non-invasive detection of the gastrointestinal positions of single and multiple ingested     capsules in real time. Dedicated post-processing algorithms are applied to extract parameters     of intestinal motor activity from the detected intraluminal capsule movements.      The proposed unique imaging modality allows for the concurrent, non invasive and repeated     analysis of important physiologic parameters of intestinal function together with detailed     anatomical information and thus presents an ideal tool for the evaluation of the analyzed     parameters as potential biomarkers in IBS.        -  Trial with medical device   "
147934|NCT01347905|"     The objective of this study is to investigate if weight loss, in particular due to adipose     tissue loss, in obese patients will reverse the obesity-related reduction of iron absorption,     and if this is due to a decrease in hepcidin concentrations. Additionally, the investigators     will investigate changes in iron incorporation into erythrocytes due to a reduction of iron     sequestration by the adipose tissue and reticuloendothelial system. The investigators expect     that by decreasing adiposity, circulating hepcidin levels will decrease, iron absorption and     incorporation into erythrocytes will increase and as a result iron status will be improved.   "
147935|NCT01347892|"     The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT     Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting.     Outcomes to be assessed include pain, function, activity levels and healthcare resource use.   "
147936|NCT01347879|"     This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy     (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that     Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is     different compared to vehicle PDT at week 12.   "
147937|NCT01347866|"     After the fourth protocol amendment two study arms are evaluated in this clinical protocol:     PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and     PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and     pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum     tolerated doses are identified, further assessment of these combinations will be done in     patients with previously treated metastatic colorectal or pancreatic cancer for the     PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small     cell lung cancer for the combination of PF-05212384 plus PD-0325901.   "
147938|NCT01347853|"     This was a randomized, double-blind, placebo-controlled study in subjects who underwent major     surgery. Each subject's study participation consisted of a screening visit and a treatment     period of up to 5 days. Following surgery (Day 0), subjects were randomly assigned to receive     intranasal ketorolac 30 mg or intranasal placebo when the pain intensity (PI) rating equaled     at least 40 mm on a 100-mm visual analog scale (VAS). Subjects received study drug every 8     hours for 48 hours and then 3 times daily for up to 5 calendar days in total; the frequency     of dosing could be reduced after 48 hours. Starting at the time of the first dose of study     drug and continuing for the first 48 hours after surgery, the subjects had access to morphine     sulfate (MS) administered via patient controlled analgesia (PCA). After PCA was no longer     required, backup pain relief was provided by another standard nonsteroidal anti-inflammatory     drug (non-NSAID) analgesic regimen. If the subjects were discharged before postoperative Day     4, they could self-medicate at home through postoperative Day 4. A safety follow-up     evaluation was conducted by telephone approximately 14 days after the end of dosing in a     subset of subjects (n = 60).      The primary objective was to evaluate the analgesic efficacy of multiple intranasal doses of     ketorolac administered for up to 5 days. The secondary objective was to evaluate the safety     and tolerability of this dosing regimen.   "
147940|NCT01347827|"     The goal of this study is to determine if off-pump CABG surgery is associated with better     cerebral tissue oxygenation when compared with on-pump CABG. In addition, the investigators     would like to compare the results of two different monitors of brain tissue oxygenation with     each other, and assess the correlation between brain tissue oxygenation and oxygenation     measurements in renal and muscular tissue, as well as with conventional hemodynamic and     metabolic variables, such as central venous oxygen saturation (ScvO2). Finally, the     investigators aim to determine if duration and extent of cerebral oxygen desaturation predict     outcome variables such as postoperative cognitive performance.   "
147941|NCT01347814|"     The purpose of this study is to determine whether domperidone was sufficient to accelerate     gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult     population.   "
147942|NCT01347801|"     The purpose of this study is to determine the role of inflammation and the insulin regulating     hormone GLP-1 during critical illness.   "
147943|NCT01347788|"     Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib     works by blocking the angiogenesis, or the growth of new blood vessels, to the tumor. This     is similar to how several other cancer drugs work but in addition Cabozantinib also blocks     other pathways that may be responsible for allowing cancer cells to become resistant to these     other anti-angiogenic treatments. So far cabozantinib has been investigated in treating     brain cancer and a rare form of thyroid cancer. This study will explore lower doses of     cabozantinib with the goal to find the most effective, safe, and tolerable dose without     undesirable side effects.   "
147944|NCT01347775|"     This study will investigate whether inspiratory muscle training in patients with end stage     renal failure can improve strength and function.   "
147945|NCT01347762|"     Cannabis use disorders are an important public health problem in the United States, but there     are no effective medications available to treat these disorders. The investigators intend to     test a medication with interesting properties, nabilone, as a treatment for cannabis     dependence and to study the relationship of this treatment with the brain using functional     MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and the human     body, suggesting that nabilone may decrease cannabis withdrawal symptoms while allowing     treatment-seeking patients to benefit from behavioral treatments when they are trying to stop     using cannabis. The investigators propose to assess the relationship of nabilone, when added     to behavioral treatment, on cannabis use patterns in cannabis-dependent patients. The     investigators also aim to determine the effects of nabilone on performance on     neuropsychological tests and to assess the correlation of neuropsychological performance to     brain changes using functional MRI brain scans. The investigators hypothesize that patients     receiving nabilone will reduce their use of cannabis more than patients receiving placebo     during this 10-week treatment trial.   "
147946|NCT01347749|"     This project will study whether a new therapy that includes the practice of forms of     meditation is helpful for combat veterans returning from deployments in Iraq or Afghanistan     suffering with posttraumatic stress disorder (PTSD). Mindfulness meditation cultivates     present-focused, non-judgmental attention to ones body, emotions, and thoughts, and is     proposed to lead to a greater sense of well-being and acceptance and better tolerance of     painful and distressing emotions. Compassion and loving-kindness meditations help     stabilize positive emotions like love and compassion, and may also be helpful for chronic     pain, and possibly depression and PTSD.      This study will compare a 16 week psychotherapy group for PTSD involving Mindfulness and     Self-compassion meditation, with a more standard form of group psychotherapy known as     Present-centered group therapy. Both therapies will be conducted at the VA Ann Arbor PTSD     clinic by VA psychotherapists. (The study is also approved by the IRB of the VA Ann Arbor).     Combat veterans will be randomly assigned to either the Meditation or the standard group     psychotherapy. All patients will also receive fMRI brain scans before and after the therapy,     as well as assessment interviews before, at 8 weeks, and immediately post-therapy, and at 3     mo and 6 mo follow-ups. Saliva cortisol and measures of attention will also be obtained at     each assessment.   "
147947|NCT01347736|"     This pilot clinical trial studies how well scrambler therapy works treating chronic pain in     patients with rash from varicella zoster virus infection. Scrambler therapy may help relieve     pain from a rash caused by varicella zoster virus infection   "
147948|NCT01347723|"     This pilot clinical trial studies scrambler therapy in treating pain and peripheral     neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help     relieve pain from peripheral neuropathy caused by chemotherapy   "
147949|NCT01347710|"     The primary objective of the study is to assess the diagnostic efficacy (specificity and     sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to     single photon emission computed tomography (SPECT) MPI in the detection of significant     coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a     documented history of Myocardial Infarction (MI).   "
147950|NCT01347697|"     The trial compares two different techniques for reconstruction of the lesser pelvic floor     after an extended abdominoperineal excision for locally advanced rectal cancer. The     alternative reconstruction techniques in the trial are:        -  a technique using a gluteus maximus myocutaneous flap or        -  a technique using an acellular porcine collagen implant      The primary endpoint will be physical performance six months from operation and our     hypothesis is that the technique using an acellular porcine implant will cause less impaired     physical performance compared to the technique using a myocutaneous flap.      The study is interventional, randomized and by definition a comparative effectiveness     research project.   "
147951|NCT01347684|"     The primary aim of the pilot data proposal is to compare usual care (medications) versus     multi-disciplinary treatment in temporomandibular disorder (TMD) patients.   "
147952|NCT01347671|"     The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients     with painful diabetic neuropathy.   "
147953|NCT01347658|"     The purpose of this clinical trial is to characterize drug interactions between one medicinal     herb: Echinacea purpurea and the protease inhibitor etravirine.   "
147954|NCT01347645|"     The purpose of the Phase Ib portion is to find out the highest dose of study drug that can     safely be given when tested in a small group of subjects.      The purpose of the Phase II portion is to find out how safe the study drug is when taken at     the highest dose in a larger group of subjects.   "
147963|NCT01347528|"     TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine     the efficacy of an electronic Medication Adherence Support System (MASS) in improving and     monitoring patients' medication adherence; to (2) i determine the effect of medication     adherence on hospitalization and health care consumption.   "
147964|NCT01347515|"     Hypothesis: A functional olive oil tailored to provide the best relationship between phenolic     compounds (amount and type) phenolic bioavailability and bioactivity (antioxidant and     anti-endothelial dysfunction) will be a useful tool for increasing not only circulating HDL     cholesterol concentration, but also the functionality (antioxidant, anti-inflammatory, and     reverse cholesterol transport capacity) of human HDL in vivo.   "
147965|NCT01347502|"     Using smartphone is increasing in hospital with various purpose and it has more extended     surface than non-smart phone. Therefore investigators can consider the bacterial     contamination rate of smartphone will be higher than that of non-smartphone.   "
147955|NCT01347632|"     This is a research study to determine whether bacterial vaginosis (BV) changes the     cervico-vaginal tissue (skin covering the cervix and vagina) and makes women at higher risk     for getting HIV (Human Immunodeficiency Virus). Vaginal and cervical tissue biopsies from     women with BV will be obtained and infected OUTSIDE the body (ex vivo) with HIV.      BV is a vaginal infection that develops when there is an imbalance in the normal bacteria     found in a woman's vagina. It is the most common cause of vaginal discharge among women of     child-bearing age. BV infections potentially harm the safety of the tissue surrounding the     cervico-vaginal region. When the cervico-vaginal tissue is not well protected, the risk of     acquiring HIV from an infected partner might increase significantly. Studies have shown that     HIV is more common in women with BV than in women with normal vaginal bacteria.      Treatment of BV typically involves the use of antibiotics. Antibiotics kill harmful bacteria     and provide a temporary relief from the symptoms caused by the infection. Women participating     in this study will use the generic antibiotic metronidazole, also known as Flagyl. The Center     for Disease Control and Prevention (CDC) recommends Flagyl for the treatment of BV.      The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3     different time periods:        1. During a BV infection        2. Approximately 1 week after completing a 7-day course of metronidazole therapy        3. Approximately 1 month after completing the 7-day course of metronidazole therapy      You will not come in contact with HIV during this study - only your samples (after we have     removed them from your vagina/cervix) come in contact with HIV.   "
147956|NCT01347619|"     The investigators propose to evaluate the effectiveness of 3 different methods to promote the     dissemination and adoption of evidenced-based review guides into the nursing home setting.     Specifically, the investigators will adapt Comparative Effectiveness Research (CER) Review     products developed by the Agency for Healthcare Research and Quality (AHRQ), specifically     related to off-label use of atypical antipsychotic drugs, to improve their penetration into     practice in the nursing home (NH) setting.      The investigators propose the following specific aims:      AIM 1: NEEDS ASSESSMENT To conduct a needs assessment for the NH setting relevant to the AHRQ     Comparative Effectiveness Research Summary Guide (CERSG) entitled Off-Label Use of Atypical     Antipsychotic Drugs. The assessment will identify: (a) interest in and barriers to the use     of the AHRQ atypical antipsychotic CERSG in the NH setting; (b) the key audiences and     stakeholders that influence atypical antipsychotic drug use in NHs; and (c) approaches to     integrating comparative effectiveness research products into the NH setting.      AIM 2: PRODUCTION OF THE TOOLKIT Guided by the needs assessment, the investigators will     produce a toolkit containing tailored CERSG-based products targeting key audiences and     stakeholders in the NH setting. The target audience(s) of the final CERSG-based products will     be identified in Aim 1, and will potentially include: (a) facility leadership [NH     administrator, Medical Director, Director of Nursing]; (b) prescribers and consultant     pharmacists; (c) nursing staff [registered nurses, licensed practical nurses, and certified     nurse assistants].      AIM 3: EVALUATING THE EFFECTIVENESS OF THE TOOLKIT To evaluate the effectiveness of the     toolkit and three dissemination strategies using a matched, cluster randomized trial. NHs in     the first arm will receive the toolkit only and web access to the materials; NHs in the     second arm will receive the toolkit, web access, periodic audit and feedback reports of     antipsychotic prescribing to NH leadership, and faxed educational messages adapted from the     AHRQ atypical antipsychotic CERSG to prescribers; and NHs in the third arm will receive the     previous items plus face-to-face academic detailing. Primary outcomes of the evaluation are     the RE-AIM evaluation domains (reach, efficacy, adoption, implementation, and     maintenance).The investigators will also include an assessment of facility-level changes in     the use of atypical antipsychotic drugs.   "
147957|NCT01347606|"     Thyroid surgery has potential risks. Intraoperative organ (such as parathyroides) extraction     and vascular or neural (such as recurrent nervus) injuries are most important ones. This     research is aim to prevention of these via intraoperative methylene blue using.   "
147958|NCT01347593|"     Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.   "
147959|NCT01347580|"     The aim of this study is to determine whether initiation of ticagrelor as early as in the     ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore     facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the     patient.      The study will assess the efficacy and safety of pre-hospital compared to in-hospital     administration of ticagrelor in co-administration with aspirin, on restoring the blood flow     in the occluded heart artery and improving the myocardial perfusion in patients suffering     from myocardial infarction and planned to have a PCI. Patients can be randomised in either     one of the 2 arms:      re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the     pre-hospital administration and placebo for in-hospital administration.      or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital     administration and 180 mg ticagrelor loading dose for in-hospital administration.      Patients are initially managed by ambulance physician/personnel in pre hospital settings.     They are then transferred into a Catheterization room to undergo a PCI.      After the administration of the loading dose of ticagrelor (double blind), patients will     continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.   "
147960|NCT01347567|"     The purpose of this study is to determine if heart failure subjects whose treatment is     assisted by home BNP measurements integrated into a home health management system will have     better clinical outcomes than subjects whose treatment includes home health management     without BNP or than subjects treated by standard care.   "
147961|NCT01347554|"     Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was     derived from studies comparing EES with bare metal stent (BMS) or EES with paclitaxel-eluting     (PES). Although sirolimus-eluting stents (SES) have been shown to be the most efficacious     drug regarding inhibition of neointima and late loss, there have been no previous head to     head comparisons between EES and zotarolimus-eluting stent (ZES). Both everolimus and     sirolimus are macrocyclic lactones that target the mTOR (mammalian target of rapamycin) to     reduce vascular smooth muscle proliferation after vessel injury and therefore in principle     may show similar results after stenting in humans. Data pooled from the EES arm that received     follow up angiography in the SPIRIT III trial and the SES arm in the SIRIUS trial show     similar rates of binary restenosis and late loss. However, the stent and polymer platform is     not the same between the EES and ZES and it is reported that the EES system has the thinnest     stent + polymer thickness (88.6um) of all of the previously KFDA-approved drug-eluting stent     (DES). In addition, there are no data available on the efficacy of the EES and ZES in real     world lesions other than the selected lesions studied in the previous trials, such as acute     myocardial infarction.   "
147962|NCT01347541|"     This pilot study will evaluate the implementation of a stepped care intervention that     combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications,     and information technology innovations at a level 1 trauma center to community linkage     components to reduce the symptoms of posttraumatic stress disorder and related comorbidities     in injured trauma survivors treated in the emergency department and surgical inpatient     settings.   "
147969|NCT01347450|"     Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these     compounds have displayed both in vitro and in vivo antioxidant activity.      Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and cocoa     powder, over plasma lipids of young males subjected to ex vivo lipid peroxidative conditions.      Design: Single-blind, controlled and randomized clinical trial including 100 healthy men,     divided into two groups: 50 subjects received 30 g of cocoa powder and 50 g of dark     chocolate/d for 1 wk, and the other 50 subjects received placebo.   "
147970|NCT01347437|"     HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,     when taken correctly (≥ 90% of prescribed doses taken), can vastly improve life expectancy.     However, adherence among HIV-infected young people is suboptimal, and few interventions are     available to help adolescents adhere to treatment.      The study is a randomized controlled trial (RCT) pilot trial of Positive STEPS (the adapted     form of the Life-Steps behavioral intervention) to improve medication adherence among     HIV-infected youth. The study will allow us to demonstrate participant acceptance, ability to     recruit, feasibility of intervention delivery with study counselors and all study procedures,     and initial clinically significant improvement in medication adherence via MEMS caps. This     research will lay the groundwork for a federal grant application for a multi-site randomized     controlled intervention trial.   "
147971|NCT01347424|"     Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion     liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow     perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus     paclitaxel and carboplatin regimen.   "
147972|NCT01347411|"     The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is     enough scientific evidence that supports the association between apnea-hypopnea syndrome     (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of     this study is to estimate the effectiveness of the continuous positive pressure airway (CPAP)     in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction     and sleep disordered breathing during the sleep.   "
147973|NCT01347398|"     The diagnosis of OSASH requires expensive sleep tests that generate long waiting lists, so we     need simplified and rapid diagnostic tools. The ApneaLinkTM, is a device that allows the     assessment of respiratory events by measuring the flow ventilation with a nasal cannula     connected to a pressure transducer.   "
147974|NCT01347385|"     The objective of this study is to determine if the use of a new type of barbed suture     material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional     approach of suturing with conventional suture material to close the uterine defect once the     fibroid has been removed, improves surgical outcomes. Specifically, the investigators will     investigate the effect of barbed suture on operative time, blood loss, adverse post-operative     events and hospital stay.   "
147975|NCT01347372|"     Peer support (including informational, emotional, appraisal support) has been shown to help     persons with chronic conditions. The goal of this research is to examine the impact of early     peer support on the health and quality of life of individuals with early inflammatory     arthritis (EIA). The investigators hypothesize that early peer support will result in     improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment,     self-efficacy, coping efficacy, social support, health-related quality of life,     self-management, and disease activity score as well as reduced anxiety for individuals with     EIA within 2 years of their diagnosis. In this study, persons with IA will be trained as peer     mentors using a training program developed for a pilot study. Individuals with EIA will be     randomized to receive either peer support program or standard care. Peer mentors will be     paired with a person with EIA to provide one-on-one support (face-to-face or telephone) once     a week for approximately 30 minutes over a 12-week period. All standard care participants     will receive the peer mentoring intervention at the end of study. Both groups will be     evaluated using self-administered questionnaires and clinical assessments, and results of the     two groups will be compared. This information will be used to design a larger study.   "
148003|NCT01347008|"     Early phases of systemic sclerosis is characterized by inflammatory and microvasculature     alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance     vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on     hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.   "
148004|NCT01346995|"     The purpose of this study is to evaluate the effects of experimental knee pain on the muscle     strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized     that experimental knee pain will reduce the muscle strength gain following strengthening     exercises in healthy volunteers.   "
147976|NCT01347359|"     Peer support (including informational, emotional, appraisal support) has been shown to help     persons with chronic conditions. The goal of this research is to examine the impact of early     peer support on the health and quality of life of individuals with early inflammatory     arthritis (EIA). The investigators hypothesize that early peer support will result in     improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment,     self-efficacy, coping efficacy, social support, health-related quality of life,     self-management, and disease activity score as well as reduced anxiety for individuals with     EIA within two years of their diagnosis. In this study, persons with IA will be trained as     peer mentors using a training program developed for a pilot study. Individuals with EIA will     be randomized to receive either peer support program or standard care. Peer mentors will     be paired with a person with EIA to provide one-on-one support (face-to-face or telephone)     once a week for approximately 30 minutes over a 12-week period. All standard care     participants will receive the peer mentoring intervention at the end of study. Both groups     will be evaluated using self-administered questionnaires and clinical assessments, and     results of the two groups will be compared. This information will be used to design a larger     study.   "
147977|NCT01347346|"     This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell     genetherapy for the Wiskott-Aldrich Syndrome.   "
147978|NCT01347333|"     This study will evaluate the local control rate as well as acute and late toxicity rates of     stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary     liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.   "
147979|NCT01347320|"     The investigators want to evaluate if preoperative MRI improves the surgical results,     especially in respect to surgical margins. The impact on the surgical procedure will be     evaluated.      In addition the investigators will examine the accuracy of tumor detection, localization and     staging.   "
147980|NCT01347307|"     This study will evaluate the local control rate as well as acute and late toxicity rates of     stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine     tumors.   "
147981|NCT01347294|"     The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and     bleomycin and fibrovein in the treatment of venous malformation.   "
147982|NCT01347281|"     The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with     [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with     blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4     PET imaging (iv) compare [18F] HX4 PET uptake with [18F] FDG PET uptake before and after     treatment.   "
147983|NCT01347268|"     Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation     induction and is a life threatening iatrogenic complication. In patients with GnRH agonist     protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated     with a reduction in (E2) levels with subsequent decreasing the incidence and severity of     OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which     GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients     at risk of severe OHSS.   "
147984|NCT01347255|"     The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous     spray ointment, using the psoriasis plaque test modified from the method developed by KJ     Dumas and JR Scholtz.   "
147985|NCT01347242|"     This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell     genetherapy for the Wiskott-Aldrich Syndrome.   "
147986|NCT01347229|"     The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting     and supine body positions and correlate the values obtained with conventional tonometers to     the output provided by the investigational device.   "
147987|NCT01347216|"     In view of the manifold options for mono- and combination therapy that have now emerged for     patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can only     provide part of the information needed for optimal management. In order to gather adequate     data on PAH/PH treatment in routine clinical care, the ongoing COMPERA registry prospectively     documents consecutive patients with newly initiated treatment of PAH/PAH since May 2007. The     internet-based registry fulfills high quality standards through several measures (planned     minimum centre contribution of at least 10 patients per year, automated plausibility checks     of data at entry, queries, monitoring with source data verification in >50% of participating     centers). It can be applied, among further purposes, for quality assurance: individual     centers can confidentially compare their results with the combined outcome of other centers     and the recommendations from guidelines. It is expected that the register contributes to     optimization of specific drug therapy for PAH and PH.      Since July 2013, also children of any age can be documented (COMPERA-KIDS).   "
147988|NCT01347203|"     This will be a study existing of 4 periods, to evaluate for a single dose of 4 different     tablets of DPOC-4088 the absorption and elimination from the body and the potential effect on     blood clotting. The differences between the tablets are the dose (100 or 200 mg) and the rate     of release of DPOC-4088 from the tablet (16 or 20 hours). The allocation of the tablets in     each period will be determined by chance but is known upfront.   "
147989|NCT01347190|"     Study to assess safety and tolerability of a single dose of study-drug administered to Cystic     Fibrosis (CF) patients.   "
147990|NCT01347177|"     Adhesive bridges are becoming popular in patients with congenitally missing teeth and these     are type of bridges that can be done with only minimal or with no preparation to replace the     missing tooth/teeth. The best clinical gain is the minimal tooth preparation or no need for     the removal of tooth substance. Treatment for this type of bridges does not usually require     anaesthesia. In addition, adhesive bridges can provide reasonable aesthetical outcome with     minimal cost and reduced chair time.      The biggest issue is that high failure rate in the long term, and gray colour shining through     the metal wing cemented onto the abutment tooth. This can compromise the aesthetical outcome.     The aesthetical problem can be solved by the use of zirconia all ceramic material to     construct the bridge.   "
148005|NCT01346982|"     This is a clinical trial to characterize drug interactions between silimarine and the     protease inhibitor darunavir/ritonavir.   "
147991|NCT01347164|"     Black men who have sex with men (MSM) have the highest rates of HIV infection in the United     States and represent a population in need of new HIV prevention interventions. Although 20 to     40% of Black MSM are estimated to have female partners, no interventions tailored to the     needs of Black MSM/W have been developed and rigorously evaluated. This project will develop,     implement, and evaluate an individual-level intervention (ILI), titled RISE, that will     assist Black MSM/W to reduce their risk for acquiring and transmitting HIV infection. This     intervention will address the effect of individual level factors, interpersonal relationships     including sexual, peer and family relationships, and socio-cultural influences on the sexual     risk behaviors of MSM/W. The intervention will consist of six counseling sessions held     between a trained counselor and participant, and will be guided by three theoretical     perspectives: an ecological perspective of behavior, stress and coping theory, and social     cognitive theory. The COLOURS Organization, the sole agency in Philadelphia dedicated to     exclusively serving the Black LGBT community, will be a key collaborator in the development     and implementation of the intervention. The evaluation design utilizes a randomized     controlled trial to test the effectiveness of the proposed intervention. Chain referral,     based on principles of respondent-driven sampling, will be used to recruit 250 HIV-positive     and HIV-negative Black bisexually-active men into this study.      The specific aims of this research are to:        -  develop a new theoretically-based individual-level HIV prevention intervention          culturally tailored to the needs of HIV-positive and HIV-negative Black MSM/W;        -  evaluate the intervention with a randomized control group design, using RDS to recruit          250 Black MSM/W who do not inject drugs and who report recent unprotected sex;        -  assess the efficacy of the intervention and test the intervention model through the          collection of behavioral risk assessments and HIV and STD testing at three time points:          baseline, immediately post-intervention and three-months post-intervention;        -  examine and describe individual factors, interpersonal relationships and network          factors, and socio-cultural factors that may affect risk behaviors for HIV infection and          transmission among Black MSM/W;        -  develop recommendations for recruiting Black bisexually-active men and providing them          with targeted HIV prevention interventions.      Evaluation data collection will be conducted using ACASI. Data analysis will include Repeated     Measures ANOVA to make assessments of changes over time and intervention dose effects and     structural equation modeling to assess causal associations between factors in the conceptual     model. This proposed study has significance for increasing our understanding various types of     factors that may affect sexual risk behaviors of Black MSM/W as well as potentially providing     an important new tool for HIV prevention specifically targeting the needs and risk behaviors     of Black MSM/W.   "
148168|NCT01344837|"     This research study is studying biomarkers in blood and tissue samples from patients with     uterine cancer. Studying samples of blood and tissue from patients with cancer in the     laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers     related to cancer.   "
147992|NCT01347151|"     Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view     with minimal cervical spine movement. This study wants to compare cervical spine movement     during intubation when using these two devices. The C-spine motion will be recorded by using     fluoroscopic video to measure the angular displacement of the vertebrae.   "
147993|NCT01347138|"     Depression in late life has been associated with losses in functioning and quality of life,     mortality, and increased health care costs. Although late life depression can be successfully     treated with antidepressant medication or psychotherapy, few older adults receive adequate     trials of such treatment in community in Korea. Barriers, such as loss of loved ones, medical     illnesses, and social stigma associated with depression, lack of social and financial     support, to effective treatment of depression can be especially problematic for older adult.     Screening has been valuable in overcoming barriers to diagnosis. Over 60 year old community     dwelling people will be screened for symptoms of four geriatric conditions (depression,     dementia, urinary incontinence, and sleep disorder). Those who will be screened positive for     each condition will be refer to clinic for diagnosis. Among them only those cases confirmed     as depression by psychiatrists will be enrolled in this study. Enrolled patients will be     randomly assigned to either case management or usual care conditions.      The objective of the study is to test whether a system of screening, assessment, and     follow-up provided by case manager improves in recognizing the target geriatric conditions     (depression, dementia, urinary incontinence, and sleep disorder) and healthcare outcomes.   "
147994|NCT01347125|"     This study is designed to evaluate the ImCardia safety and to demonstrate system     functionality in patients undergoing AV replacement with respect to 36 months follow up.   "
147995|NCT01347112|"     Alcohol dependence is a significant and prevalent public health problem affecting     approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively     seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the     high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk     for both morbidity and mortality related to alcohol consumption and tobacco dependence.     Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering     alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently     drinking alcoholic smokers.      Varenicline is the most effective medication currently available for treating tobacco     dependence. While some randomized trials have included recovering alcoholics, active     alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the     first such clinical trial in currently drinking alcoholic smokers. In addition to helping     smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in     rats. The goal of this proposal is to explore the potential efficacy of varenicline for     treating tobacco dependence and reducing drinking among alcohol dependent smokers.      The investigators hypothesize that 12 weeks of treatment with varenicline, a partial     nicotinic acetylcholine receptor agonist will be more effective than placebo in treating     tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic     smokers. The investigators will also explore whether varenicline has an effect on drinking     behavior among currently drinking alcoholics. The investigators propose the following     specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited     at the Mayo Clinic in Rochester, Minnesota.   "
147996|NCT01347099|"     Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder     (OCD) but there is a lack of properly trained CBT therapists. One possible treatment     alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study     was therefore to evaluate ICBT for OCD.   "
147997|NCT01347086|"     The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and     Caucasian healthy male volunteers administered BI 207127 NA.   "
147998|NCT01347073|"     This non-randomized, open-label study was approximately one year in duration and consisted of     a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a     12-month long term treatment period involving monthly visits.   "
147999|NCT01347060|"     The objective of this study is to compare healthcare utilization and costs in     Medicare-eligible asthma patients (aged >65) who receive fluticasone propionate/salmeterol     xinafoate combination or inhaled corticosteroids in a typical clinical practice using a     retrospective observational cohort study design of large managed care database. Outcomes on     interest include asthma related severe exacerbations defined as asthma related emergency     department visits, hospitalizations or combined emergency department/hospitalization. Other     outcomes of interest include use of albuterol, oral corticosteroids and overall asthma     related costs. Outcomes of interest will be compared between the two treatment cohorts     (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids).     Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox     regression hazards analysis assessing time to first event for each asthma related endpoint     adjusting for differences in baseline demographics such as age, gender, previous asthma     medication use, co morbidities, costs, and plan demographics. Total asthma related costs will     also be compared using generalized linear models adjusting for baseline differences.   "
148000|NCT01347047|"     1. Creating a population-based registry system Amyloidosis prospective epidemiological          survey             -  risk factors             -  diagnosis             -  prognosis             -  treatment             -  monitoring             -  survival        2. Describe the occurrence of amyloidosis in the population of HIBA, Hospital Italiano de          Buenos Aires.        3. Describe the characteristics of clinical presentation, evolution and predisposing          factors of amyloidosis.   "
148009|NCT01346930|"     The MUSIC OL study is an open-label extension study, in which all eligible patients having     completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once     daily. The study objective is to assess the long-term safety and tolerability of macitentan     in patients with idiopathic pulmonary fibrosis (IPF).   "
148010|NCT01346917|"     The purpose of this study is to determine whether intravenous lidocaine increase the     tolerability of early oral feeding after laparoscopic colorectal surgery in patients with     colorectal cancer.        -  Degree of nausea/vomiting.        -  Degree of postoperative pain and opioids requirement.        -  Time to first flatus, time to first stool, time to tolerance of regular diet, rate of          postoperative complications and duration of postoperative hospital stay.   "
148011|NCT01346904|"     Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across     optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex;     the neural degenerations could be identified through the whole visual tract, which suggests     the central nerve system may play a vital role in the progression of glaucoma. The     investigators used MRI to investigate changes of visual pathway in vivo.   "
148012|NCT01346891|"     The purpose of this study is to detect if there are any differences in the coding region of     SLC12A3 gene in individuals who have had hyponatremia associated to the use of thiazides, and     those thiazides consumers without hyponatremia that have demonstrated good tolerance to the     drug.   "
148013|NCT01346878|"     This study aims to analyze the association between the baseline detection of resistance     mutations through Ultra deep Sequencing (UDS) and the virological outcome of salvage     antiretroviral therapy, in comparison with conventional genotypic resistance tests. Based on     the data generated in this study, new resistance interpretation tools and algorithms will be     developed to improve the prediction of antiretroviral therapy outcomes. The final aim of the     study is to improve the clinical care of HIV-1-infected patients through the incorporation of     improved new antiretroviral resistances tests in the clinical practice.   "
148014|NCT01346865|"     The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase     4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual     antiplatelet therapy in patients treated with DES for Coronary Artery Disease.      The primary objective of this study is to compare the safety and efficacy of triple     antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with     drug-eluting stent (DES) implantation for the treatment of coronary artery disease.   "
148015|NCT01346852|"     The purpose of this study is to assess the predictive ability of three asthma risk markers:     the ratio of controller medication to total asthma medication, an albuterol only marker, and     an oral corticosteroid use marker, as well as to compare the precision of these tools between     adult and pediatric patient populations. This retrospective longitudinal analysis will use 2     different databases: a large managed care database and a large fee for service Medicaid     database.   "
148016|NCT01346839|"     Diagnostic delays in ambulatory care are often due to breakdowns of related care processes.     Electronic systems can improve follow-up and reduce delays by detecting missed appointments     or incomplete procedures so that patients are called back to conduct timely investigations     when appropriate. To achieve high standards of patient safety in cancer diagnosis, the     investigators not only need to use information technology appropriately but also improve the     processes, policies, and procedures of monitoring, communication, and coordination of care.      Given the importance of cancer-related diagnostic delays in ambulatory care, the     investigators need effective methods to detect them, understand their causes, and intervene     to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and     random chart reviews, have limited effectiveness. Our proposed study focuses on testing     methods to proactively identify delays using certain triggers as they occur and intervene     in a timely manner.   "
148017|NCT01346826|"     This study aims to test the hypothesis that the accelerated infusion of infliximab is not     inferior to the conventional 2 hour infusion with respect to the frequency of infusion     reaction.   "
148018|NCT01346813|"     Sick or premature neonates are exposed to frequent painful and stressful procedures during     their stay in neonatal intensive care units. Although neonates do feel pain and may have long     term effects induced by painful experiences, prevention and treatment of neonatal pain is far     from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and     pediatric intensive care units in France in 2005 showed that painful procedures were     extremely frequent and that analgesics treatments varied a lot among units. Since many     guidelines have been issued by international scientific societies to manage neonatal pain,     one may expect that the prevention and treatment of neonatal pain has improved over the last     6 years.      Although awake endotracheal intubations are extremely difficult or impossible in older     children or adults, such intubations are still frequently performed without     sedation/analgesia in neonates. Recent studies have shown that premedications facilitate     intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed     at assessing the risks and benefits of different sedations/analgesia strategies are urgently     needed in neonates. We also need a tool to assess at the same time the technical conditions     of intubations and the tolerance of the neonate to the procedure so that data from different     studies can be compared.      The objectives of the present study are:        1. To describe the incidence of painful and stressful procedures performed in the neonate          in intensive care units as well as in neonates transported by the medical emergency          system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study          conducted in the same region and same type of population in order to assess the          evolution of practices. The description of painful and stressful procedures will be          completed with a real-time around-the-clock assessment of the pain induced by procedures          using a validated behavioral pain scale.        2. To link this study with The Epipage study 2 in order to look for associations between          the number of painful and stressful procedures and/or analgesic treatments of the          neonatal period and the neurological outcome of children that will be followed in the          Epipage cohort. The Epipage study is a separate study that will follow for 13 years a          cohort of premature neonates recruited in 2011.        3. To describe the incidence of painful or stressful procedures and analgesic treatments in          neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France          region in France.        4. To obtain initial validity of a tool permitting to assess intubations in neonates. An          observational detailed description of endotracheal intubations conditions will be          conducted in neonates transported and intubated by SMUR and in neonates intubated in          intensive care units        5. To describe continuous sedation and analgesia practices in ventilated neonates in          intensive care units. For these neonates, data from medical records will be recovered up          to 2 months of admission in intensive care units        6. To describe the frequency of heel sticks for glycemia measurement and blood gazes          practices among centers. Relate heel stick practices to the normality or abnormality of          glycemia results   "
148027|NCT01346696|"     The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 6 mm     implants in a Chinese population by evaluation of marginal bone level alteration, implant     stability and implant survival in the posterior mandible and maxilla up to 3 years after     loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the     posterior region is safe and predictable.   "
148028|NCT01346683|"     To investigate the clinical efficacy of Osseospeed™ TX implants in a Chinese population by     evaluation of marginal bone level alteration, implant stability and implant survival in the     posterior mandible up to 3 years after loading. Hypothesis: Early loading of the posterior     mandible is a safe and predictable procedure.   "
148019|NCT01346800|"     HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit     multiple known risk factors for CVD. Of specific concern is the fact that use of the non     nucleosidic reverse transcriptase inhibitors (NNRTI) and/or protease inhibitors (PI) drug     classes is associated with dyslipidemia known to increase the risk of coronary heart disease     particularly among older subjects with normalized CD4 cell counts and suppressed HIV     replication. HIV patients could thus potentially receive anti-aggregant therapy concomitantly     with their antiretroviral treatment. Prasugrel is an anti-aggregating agent indicated to     prevent the recurrence of ischemic events after coronary arteries stenting. It is a pro-drug     mainly metabolized by cytochromes P450 (CYP) 3A and 2B6 and to a lesser extent by CYP2C9 and     2C19. Ritonavir is an anti-protease and CYP3A4 and CYP2B6 inhibitor used in anti-HIV therapy.     The aim of the present study is to assess the potential drug-drug interaction between     prasugrel and the CYP3A/2B6 inhibitor ritonavir. Ten healthy volunteers will receive     prasugrel 10mg alone or after 100mg ritonavir. The effect of ritonavir on prasugrel     pharmacokinetics will be assessed. The two sessions will be separated by a one-week wash     out period. During each session, CYP3A, 2B6, 2C9 and 2C19 activities will be assessed by a     micrococktail approach with microdoses of midazolam, bupropion, flurbiprofen and omeprazole.     The pharmacokinetics of prasugrel active metabolite will be assessed during the two sessions.   "
148020|NCT01346787|"     The purpose of this study is to determine whether the association of Carfilzomib,     Cyclophosphamide and Dexamethasone (CCd) as induction treatment is safe and provides benefits     in patients with newly diagnosed Multiple Myeloma (MM).   "
148021|NCT01346774|"     Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter     associated urinary tract infection (CAUTI) in the post operatory period, as bladder     catheterization is a common practice in gynecologic surgery. Cranberry products provide     alternative means for preventing CAUTI and could result in decreased use of antimicrobials.     In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to     take either cranberry powder capsules or placebo powder capsules. The low risk of harm     associated with using cranberry to reduce UTI coupled with its potential benefit makes it a     desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot     /feasibility study will prepare us for the conduct of a large scale clinical trial.   "
148022|NCT01346761|"     Individuals living in geographically underserved areas encounter considerable barriers to     access of quality cancer genetic services. Although in-person genetic counseling has     generally been accepted as the standard of care, the use of telecommunications to deliver     clinical genetic services may help reduce this disparity in access to such services. However,     before the widespread adoption of telephone-delivered cancer genetic services occurs, it is     critical to analyze the efficacy and safety of this mode of communication. This two-group     randomized equivalency/non-inferiority trial will determine whether telephone-based cancer     genetic counseling is an acceptable alternative to the traditional in-person mode among women     who have a personal or family history of breast and/or ovarian cancer strong enough to     warrant genetic counseling and testing. This study's findings will provide important     information to cancer centers and cancer control policies about the safety, efficacy, and     costs of delivering telephone-based clinical cancer genetic services for geographically     challenged women at risk for having Breast Cancer susceptibility gene (BRCA) 1/2 mutations.   "
148023|NCT01346748|"     Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and     mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in     the last years. Phase II randomized clinical trials have demonstrated that statin decreases     the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage.     Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though     some articles have shown that statins provide better prognosis, some issues remain in debate,     e.g., treatment duration and the choice of the statin.   "
148024|NCT01346735|"     Most literature on ICU infections and the resistant patterns comes from the western     literature. This data may not truly reflect the incidence, epidemiology and resistance     patterns in developing countries such as India. However, empiric antibiotic therapy is     generally initiated using western guidelines. This can potentially lead to inadequate,     inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian     setting. Hence in this multi-center observational study, we seek to:        1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India        2. To explore the microbiology, resistance and treatment patterns of these infections   "
148025|NCT01346722|"     It is well documented that zinc supplementation to low-income population results in the     reduced incidence of childhood diarrhoea and pneumonia, and improves growth of stunted     children. Implementation of large scale programmes are needed for prevention of zinc     deficiency in areas where it is common. In Bangladesh, the risk of zinc deficiency is     considered to be high and children could benefit greatly by improving their zinc intakes on a     daily basis. Zinc supplementation at a national scale would be a formidable task and even if     implemented might not be sustainable in the long range. There thus is a need to find an     alternative. It might be sustainable to improve intake of zinc through fortified staples,     e.g. rice with increased amounts of zinc; in fact such biofortified rice has been developed     through conventional breeding, which is designed to contain an amount of zinc that could meet     at least 40% of the daily requirement.      To assess the potentials for biofortified rice in providing a good, bioavailable source of     additional zinc, the investigators propose to measure zinc absorption from rice-based meals     among Bangladeshi preschool children. Specifically, the investigators will measure the amount     of zinc absorbed from zinc-biofortified rice (Diet-ZBfR, 24 mg Zn/kg), compared to that     absorbed from a conventional Bangladeshi rice (Diet-CR, 16 mg Zn/kg) (control). The     investigators will also compare the zinc absorption from biofortified rice with that from     zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized,     controlled clinical study. In total, 42 children aged 36-59 months of either sex will be     recruited from a peri-urban community in Dhaka, and they will be individually randomized, in     equal numbers, to one of the two comparison groups, A and B. The group A children will     receive zinc biofortified rice-based diet (Diet-ZBfR) and conventional rice-based diet     (Diet-CR) using a randomized, cross-over design. Similarly, the group B children will receive     zinc biofortified rice-based diet (Diet-ZBfR) and a zinc fortified rice based diet     (Diet-CR+Z), also using randomized, cross-over design. The investigators will use zinc stable     isotope tracer techniques to measure the fractional absorption of zinc, in which tracer :     tracee ratios will be measured in spot urine samples following administration of an     intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided     with test meals over a two-day period. If zinc from biofortified rice is found to be     adequately bioavailable, it will be tested in a randomized, controlled, efficacy trial among     rural Bangladeshi children.   "
148026|NCT01346709|"     Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe     (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of     patients undergoing a nonobstetric in-hospital surgical procedure under general or regional     anaesthesia during a continued 7-day period of recruitment.   "
148029|NCT01346670|"     The objective of the study is to evaluate the relative bioavailability of lovastatin and its     ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor®     Tablet after single oral administration in healthy subjects using a 2x2 crossover design.   "
148030|NCT01346657|"     The objective of the study is to evaluate the effect of LipoCol Forte® Capsules on the     pharmacokinetics of nifedipine after administering single-dose combination to healthy     subjects using a 2x2 crossover design.   "
148031|NCT01346644|"     In the last years manipulation of intestinal microbiota with probiotics has gained an     increasing interest, specially in infant nutrition since recent studies has demonstrated the     presence of probiotics in human milk. However, there are few studies studying the effects of     probiotics in newborns. The objective of the present study is to analyze safety and tolerance     of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.   "
148032|NCT01346631|"     Prospective studies concerning diet and male fertility are lacking. Observational studies     suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm     counts. The investigators wanted to see if a paleolithic diet consisting of meat, fish,     fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm     counts.   "
148167|NCT01344863|"     This randomized, open-label, parallel, 2-arm, multicenter study will compare the     administration of Herceptin (trastuzumab) with a single-use injection device versus a     handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600     mg Herceptin. The anticipated time of the study is 21 weeks.   "
148198|NCT01344512|"     The Pharm A project is a French national collaborative project aiming to determine the     population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric     patients aged one month to five years.   "
148033|NCT01346618|"     Bone age assessment is currently an important tool in final height implication in children.     It is an important tool in the phases of investigation and treatment of short stature, tall     stature, pubertal timing and various endocrinological pediatric situations. It is currently     assessed using hand x-ray. This method has several limitations, including: requirement of     specialized medical staff to interpret results, exposure radiation and usage of equipment     which is only in radiology centers. The investigators aim to study a new equipment, radiation     free, with simple and swift operation which provides an immediate answer, no need for an     experienced observer, a mobile equipment with easy accessibility. The aim of the study is to     assess its reproducibility, validity and safety compared to the x-ray method.      The investigators hypothesize it is as accurate and valid.   "
148034|NCT01346605|"     This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion     (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical     facilities. The study uses an electronic data capture tool to collect the de-identified data     to create a global multi-center registry. This registry will be used for scientific analysis     and publication of pertinent medical trends such as CT utilization, radiation dose, and     common cardiovascular findings.   "
148035|NCT01346592|"     This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted     Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza     Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to <     72 Months of Age.   "
148036|NCT01346579|"     This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit     alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast     cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory     may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and     identify biomarkers related to cancer.   "
148037|NCT01346566|"     The purpose of this study is to report the intraoperative performance and postoperative     outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated     lenses.   "
148038|NCT01346553|"     The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous     Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way     venous valve and a sensor that identifies the movement of the calf muscles pump. The external     device is located above the failed deep vein and exerts synchronized intermittent regulated     pressure on it. Alteration in the vein structure is occurred and the blood flows in the     cephalad direction, preventing the return toward the feet. The device is synchronized with     the calf muscles pump to function as a one-way venous valve. This study was design in order     to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic     venous insufficiency.   "
148039|NCT01346540|"     The LUME-Lung3 study is in 2 parts:      Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that     can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and     cisplatin.      Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles     of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2     previous courses of the chemotherapy   "
148040|NCT01346527|"     Background: The health of the next generation is likely programmed in the womb (i.e.in     utero), and our understanding of how that programming happens will allow us to favorably     influence the health of future generations. The focus of this proposal is to examine the     effect of in utero programming on heart function in children born to women with type 2     diabetes (T2DM). Specifically, neonates born to diabetic women have abnormal heart structure     and weaker heart function at birth, which may predispose them to long-term heart problems in     childhood, adolescence and adulthood. At present, the reason for these heart abnormalities in     children born to women with diabetes is unknown and is the focus of this proposal.      Objective(s) and Hypothesis(es): The objectives are to examine the relationships among     maternal lipid (fatty acid, triglyceride, very low density lipoprotein) metabolism and     neonatal heart structure and function in diabetes and to identify clinical markers during     pregnancy for heart dysfunction in infants born to diabetic women. The overall hypothesis is     that maternal lipid metabolism is abnormal in diabetes, and this metabolic dysregulation     increases fatty acid delivery to the fetus in utero and leads to abnormal accumulation of     lipid in the fetal heart, resulting in altered neonatal heart structure and function in     infants born to diabetic women. In addition, the investigators hypothesize that decreased     maternal fatty acid oxidation (fat burning) rate, elevated lipolytic (fat breakdown) rate     and elevated blood total free fatty acid level predicts abnormal neonatal heart structure and     function in infants born to women with type 2 diabetes.      Methods and Procedures: The investigators will test these hypotheses by using clinical     metabolism studies (infusion of stable isotope labeled fatty acid, serial blood and breath     sampling, and mass spectrometry) to quantify whole-body fat (fatty acid oxidation, lipolysis,     and serum fatty acid , triglycerides, VLDL-cholesterol levels) metabolism in 25 diabetic     women during the 3rd trimester of pregnancy, and compare these lipid metabolism kinetics to     25 body mass index matched healthy non-diabetic women during pregnancy and determine if     alterations in maternal lipid metabolism predict abnormal neonatal heart function in children     born to these women.      Potential Impact: Type 2 diabetes is an epidemic in the United States and is steadily     increasing worldwide. Diabetes has detrimental health effects in pregnant women and in their     offspring. The investigators know that children born to women with diabetes have an increased     risk for developing diabetes, obesity and cardiovascular disease, than children born to     healthy women. This proposal will address an important knowledge gap regarding the role of     maternal lipid (and potentially other nutrients) metabolism on the cardiovascular health of     the global and increasing population of children born to diabetic women. Findings from this     project will be novel and innovative, and will likely point to clinical interventions that     target and correct lipid and other metabolic abnormalities in women with pre-gestational     diabetes. The impact will be great because the long-term goal is to ameliorate heart problems     in children born to diabetic (both pre-gestational and gestational) women. In addition, this     project will establish a small cohort of children that can be followed long-term to address     novel questions about the progression of heart and other metabolic abnormalities in children     born to diabetic women.   "
148041|NCT01346514|"     The study examined intensive case management for homeless Veterans in addiction treatment by     integrating addiction/housing case managers (AHCM), operating from a Life Skills Training     perspective, into an addiction specialty program. The primary aim was to determine whether     the AHCM intervention increases number of days housed during the year following treatment     entry. Secondary aims were to compare costs and cost-effectiveness of AHCM vs. time and     attention control, determine if AHCM improves addiction outcomes and functional status, and     examine treatment process variables associated with improved outcomes.   "
148042|NCT01346501|"     The main objective of this study was to determine the ability to maintain response after     discontinuation of adalimumab treatment and the secondary objective was to determine     radiographic progression in participants participating in the study, including the percentage     who displayed minimal progression.   "
148043|NCT01346488|"     This is a single-arm, multi-center, prospective cohort study (post-marketing observational     study). The observation period for each participant is 48 weeks.      This study is designed to provide additional data on treatment effects of adalimumab during     48 weeks of treatment in patients with RA under conditions of routine rheumatology care.     Course of work productivity and work ability, the course of health-related quality of life,     and changes in functionality during 48 weeks treatment with adalimumab are to be documented.   "
148108|NCT01345630|"     The purpose of this study is to assess whether maraviroc administered once daily is     non-inferior to emtricitabine/tenofovir also administered once daily each in combination with     darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48     of treatment.   "
148044|NCT01346475|"     On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to     NCT00362297. On 28 April 2011, the two records were split for administrative purposes and     each trial was given its own unique study record. Please refer to the History of Changes on     posting NCT00362297 for a detailed summary of the modifications.      The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir     compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in     persons with genital herpes.      The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by     blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at     least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and     willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females     only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an     effective form of birth control.      Involvement in the study will last 11-weeks and you will be asked to visit the clinic every     2-weeks. At each visit, you will be given medication to take daily (either once daily     valacyclovir or high dose valacyclovir; you will receive both medications at some point     during this study). We will ask you to give a blood sample for liver, kidney and blood count     testing at each visit. There will be a total of 8 study visits and each visit will last     approximately 30 minutes. We will ask that you complete a daily symptom diary and collected     daily home swabs 4-times a day, everyday during the study. Each daily home swab will take     less than 3 minutes to perform.   "
148045|NCT01346462|"     The investigators propose a pilot randomized controlled trial of a care transitions     intervention in which trained Community Health Workers will act as supports for     socioeconomically vulnerable patients who are being discharged from the Hospital of the     University of Pennsylvania and Presbyterian Hospital. CHWs or IMPaCT Partners will help     patients to overcome the challenges of transition, including arranging primary care provider     (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based     social services. As our primary outcome, the investigators will examine the effect of the     IMPaCT intervention on rates of primary care follow-up. The investigators will also examine     the effect of IMPaCT on secondary outcome variables including patients' satisfaction with the     experience of transition, quality of discharge communication, medication adherence, self-     rated health, and inpatient readmission within 30 days after discharge.   "
148046|NCT01346449|"     The purpose of the study is to better understand how individuals make decisions regarding the     meals they order. Participants' ordering decisions at lunchtime at a chain restaurant will be     recorded over several weeks to study ordering habits over time. Lunch menus will be provided     by the study, and the menu format will vary the way in which information on caloric content     is displayed.      The impact of different labeling formats on total calories in the chosen meal will be     assessed.   "
148047|NCT01346436|"     The purpose of this randomized double blind controlled study is to assess the value of     robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare     perioperative and functional outcomes to the laparoscopic approach.   "
148048|NCT01346423|"     Musculoskeletal pain is very common in the normal population, and the reason for about 50 %     of the long term sickness absence in Norway. Most of these patients have common, but     troublesome subjective health complaints where pathological findings are absent or     substantially less than expected compared to the reported intensity of the complaints.     Psychosocial factors are important in the development of chronic complaints. In a large     meta-analysis job satisfaction was found to be associated with mental health and subjective     physical health. Individual factors are also important. Uncertainty related to the     understanding of pain mechanisms, treatment strategies and management contribute to the     problem.      Among patients sicklisted for musculoskeletal complaints, low back pain is the largest     diagnose group. Most of these patients also have many other complaints. Previous studies have     shown that for low back pain patients a brief intervention at a spine clinic with     examination, information, reassurance, and encouragement to engage in physical activity as     normal as possible, had significant effect in reducing sick leave. Other studies have shown     that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A     Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for     patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs, pain,     and function.      A treatment team consisting of various professionals is expensive, and in this study we will     compare the simple, standardized brief intervention model with the more resource demanding     interdisciplinary treatment for patients sicklisted for musculoskeletal complaints.      Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal     complaints - is it beneficial for reducing sickness absence?   "
148049|NCT01346410|"     This study will evaluate the local control rate as well as acute and late toxicity rates of     stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.   "
148050|NCT01346397|"     After alemtuzumab induction, followed with kidney transplantation, patients will be randomly     assigned to receive either tacrolimus or cyclosporine microemulsion in combination with     mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month     posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr     virus (EBV) and BK virus (BKV) in urine and blood.      The investigation is undertaken to clarify the reason for equal survival rates for patients     on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.   "
148051|NCT01346384|"     The purpose of this study is to investigate the time-related intracuff pressure and volume     change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.   "
148052|NCT01346371|"     The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye     drop on the quality of your tears.   "
148053|NCT01346358|"     A dose escalation study to establish the safety profile and characterize the pharmacokinetic     profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to     standard therapy or for which no standard therapy is available.   "
148054|NCT01346345|"     Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary     laterals and mandibular incisors   "
148055|NCT01346332|"     The study will recruit healthy volunteers to undergo the iontophoresis procedure using the     Acclarent Iontophoresis System with Headset.   "
148056|NCT01346319|"     Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of     testosterone in hypogonadal males.   "
148068|NCT01346163|"     This study will look at the impact of dosing as well as ongoing treatment with an     investigation medication identified as PF-03654746, on cognitive and physiologic indicators     of brain function. Data from this study will assist with the evaluation of the utility of     functional magnetic resonance imaging, arterial spin labeling (ASL), and electrophysiologic     measures in the detection of early signals of the effectiveness of medications developed to     target cognitive impairment in schizophrenia. Safety and tolerability of PF-03654746 in this     population will be also be evaluated.   "
148057|NCT01346306|"     Among antidepressant treatments, ECT stands as the most effective in treating acute     depression. However, patient concerns with the cognitive side effects of ECT have encouraged     the development of new and more focal forms of brain stimulation such as transcranial Direct     Current Stimulation (tDCS). However, not all patients may respond to this treatment in the     way that it is currently administered and this has raised interest in finding alternative,     possibly more optimal ways of administering tDCS. This study will investigate whether tDCS     stimulation using an alternative electrode montage has antidepressant effects. Further     sessions of tDCS, spaced less frequently, will be trialed for maintenance treatment. Mood,     cognitive test performance and biomarkers will be measured periodically in the duration of     the trial.   "
148096|NCT01345786|"     For the contraceptive application a film-coated tablet has been developed which combines     nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized,     single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at     two sites, one site per study part. The primary objective of Part 1 was to assess the     bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process     (commercial batch) versus the Phase 3 drug product (Batch A). The primary objective of     Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using     the commercial process (commercial batch) versus the Phase 3 drug product (Batch B).   "
148199|NCT01344499|"     Measurement of residual peritoneal fluid after laparoscopic surgery   "
148058|NCT01346293|"     The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® +     IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico     who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.      Primary Objectives:        -  To compare the pertussis [Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA),          Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)] booster responses and geometric mean          concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay [ELISA])          following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination          when administered as a 5th dose.        -  To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA)          following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL®          vaccinations when administered as a 5th dose .        -  To compare the Inactivated Poliovirus Vaccine booster responses (as measured by          neutralizing assay) following DTap-IPV vaccination with those elicited following          DAPTACEL® + IPOL® vaccinations.      Observational Objectives:        -  To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV          vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.        -  To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered          as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL          and/or Pentacel vaccines.   "
148059|NCT01346280|"     Background:      -Coordinated cancer care provided by doctors, nurses, social workers, and other care     providers is believed to improve patient and physician satisfaction and patient evaluation     for enrollment in clinical trials. But no research has been done to show that this approach     improves patient experiences and outcomes. Researchers want to study this model to better     understand how it can improve cancer treatment and patient outcomes.      Objectives:      - To assess the relationship between coordinated care and cancer treatment processes and     outcomes.      Eligibility:      - Individuals who are at least 18 years of age. Those who take part must have been diagnosed     with colon, rectal, or non-small-cell lung cancer. They also must be receiving or have been     treated at one of the 16 NCI Community Cancer Center program sites.      Design:        -  Researchers will collect medical records data from participants.        -  Participants will complete a questionnaire about 8 weeks after the end of all planned          cancer treatment. They will be asked questions about their experience with coordinated          cancer care. They will also be asked for any comments or concerns they had during and          after treatment.        -  No treatment or additional tests will be provided as part of this protocol.   "
148060|NCT01346267|"     RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It     is not yet known whether standard care is more effective with or without acupressure     wristbands in controlling acute and delayed nausea.      PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work     with or without standard care in controlling nausea in young patients receiving highly     emetogenic chemotherapy.   "
148061|NCT01346254|"     Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious     complication after kidney transplantation. Patients who develop NODAT are at increased risk     for loss of the transplanted organ and for diseases of the cardiovascular system.      It is believed that in many patients the development of overt NODAT is preceded by a phase of     impaired glucose tolerance that is called pre-diabetes.      This study aims at improving glucose metabolism in patients after kidney transplantation who     are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT)     after kidney transplantation are randomized to either receive vildagliptin (Galvus),     pioglitazone(Actos) or placebo for three months.      The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to     improved glycemic control compared to placebo.   "
148062|NCT01346241|"     The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA     community based outpatient clinics (CBOCs).   "
148063|NCT01346228|"     The purpose of this study is to see if a new Smart Phone application can help Veterans manage     their panic symptoms after completing a two-day treatment for panic attacks.   "
148064|NCT01346215|"     The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect     and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.)     compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under     hemodialysis treatment.   "
148065|NCT01346202|"     Complex and chronified pain syndromes requires a specialized therapeutic concept. From     patients with chronic low back pain the investigators know, that an interdisciplinary     multi-modal approach may improve the therapeutic success. In this observational study the     investigators investigated if the multi-modal pain therapy is also effective in patients with     mixed chronic pain syndromes.   "
148066|NCT01346189|"     Using a 4-arm, cluster-randomized controlled trial, the investigators will test the     effectiveness of different behavioral economic interventions in increasing statin use and     reducing LDL cholesterol among patients with poor cholesterol control who are at very high     risk for CVD. The investigators will test these approaches among primary care physicians and     their patients at very high risk of CVD at Geisinger Health System and University of     Pennsylvania outpatient clinics.   "
148067|NCT01346176|"     The investigators aim to assess the influence of default options in advance directives on     older patients selections of life- extending therapies and to determine whether alerting     patients to the spectrum of possible default options in advance directives influences their     selections of life-extending therapies by manipulating the default options of advance     directives given to patients in with severe respiratory disease   "
148134|NCT01345292|"     This study is for people with sensitive teeth and involves going to the dentist for 4 visits     over 6 weeks.      During the first 2 weeks, you will just brush your teeth two times a day with the fluoride     toothpaste provided.      Then you will be assigned to a group if you qualify to continue in the study. All groups will     get a marketed toothpaste and one group will also get a mouthwash with an experimental     ingredient. You will have an equal chance of being assigned to any one of the three groups.      For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your     assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth,     teeth, tongue and gums and check for sensitive teeth. The investigators will see if the     mouthwash helps to reduce tooth sensitivity during the study.   "
148069|NCT01346150|"     People with Primary Immune Deficiency (PID) may develop severe, life-threatening infections     as a result of inherited defects in the genes that normally instruct blood-forming cells to     develop and to fight infections. PID diseases include Severe Combined Immune Deficiency     (SCID), leaky SCID, Omenn syndrome (OS), and Reticular Dysgenesis (RD). PIDs may be treated     by transplantation of bone marrow stem cells from a healthy person or, in some cases, by     enzyme replacement or by gene therapy. Patients with SCID were among the first to receive     bone marrow stem cell (also called hematopoietic cells) transplantation (HCT) more than 40     years ago, and HCT is the standard treatment today for this group of diseases. Since PID     diseases are rare, there are not enough patients at any single center to determine the full     range of causes, natural history, or best methods of treatment. For this research study many     PID centers across North America have organized into the Primary Immune Deficiency Treatment     Consortium (PIDTC) to pool their experience and study PIDs together. Researchers will collect     information on your general health, psychological and developmental health, and the current     status of your immune system to help better define future approaches to PID treatments.   "
148070|NCT01346137|"     In this study the investigators propose to evaluate a COX-2 inhibitor(meloxicam) to assess     its effect on follicular development and find out if this regimen delays or blocks ovulation     while maintaining ovarian cyclicity. The investigators intend to administer 15 mg or 30 mg of     meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous     cycles. The 3 treatment cycles will be preceded and followed by control cycles with no     treatment. Ovulation or lack there of will be monitored by transvaginal ultrasound     examinations (TVUs), estradiol, luteinizing hormone (LH), and progesterone levels in multiple     blood samples in each cycle. The investigators will recruit a total of 56 women. Each woman     will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women assigned to     each of the 2 dose regimens. Participating women will demonstrate an ovulatory cycle before     starting meloxicam treatment and will be protected from pregnancy by prior sterilization.   "
148071|NCT01346124|"     There are two types of external radiation treatments; proton beam and photon beam radiation.     What type of therapy participants will receive will depend upon the location of their tumor.     Standard treatment would involve receiving either proton or photon radiation delivered by a     three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a     technique where the beams of radiation used in the treatment are shaped to match the tumor in     order to avoid damaging the healthy surrounding tissue. Standard treatment also may include     photon radiation delivered by intensity modulated (IMRT) technique. In this research study we     are using an investigational technique to deliver proton radiation therapy called intensity     modulated proton radiation treatment (IMPT) which is used to target cancer while sparing     healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned down during     the treatment. This control over the intensity of the radiation dose has the potential to     provide accuracy and allows us to more safely increase the amount of radiation delivered to     the tumor. This accuracy may potentially reduce side effects that patients would normally     experience with 3-D proton radiation therapy. Surgery is often an important component of the     treatment for these tumors and may be integrated with the IMPT.   "
148072|NCT01346111|"     The purpose of the study is to generate and valid a co-morbidity score with updated     definitions and suitable for use in Argentina in both public and private settings. These     tools would allow us to compare different populations in Argentina adjusting for     comorbidities. Also, this would potentially help attending physicians and health     administrators.   "
148073|NCT01346098|"     The goal of the proposal is to demonstrate that, in patients with disease of the pancreatic     head with very high-risk of complications of pancreatojejunal reconstruction (soft pancreas     and pancreatic duct diameter <3 mm), total pancreatectomy with islet autotransplantation     (IAT) is associated with a lower morbidity (in terms of surgical or medical complications)     and mortality compared with pancreaticoduodenectomy and pancreatojejunal anastomosis.   "
148074|NCT01346085|"     Our final objective is to develop an adoptive therapy with tolerogenic donor-specific Tr1     cells in T1D patients undergoing pancreatic islet transplantation (Tx). The achievement of     this objective depends by the availability of an immunosuppressive treatment (IS) compatible     with the survival, function, and expansion of the transferred Tr1 cells. For this purpose the     investigators design a CNI-free single-group, phase 1-2 trial excluding the ATG or anti-CD25     induction therapy after the 1st islet infusion   "
148075|NCT01346072|"     This pilot study will investigate the association between levels of the peptide copeptin and     response to tolvaptan, a drug that blocks the action of the water retaining hormone     vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45)     selected by targeting upper and lower quartile copeptin levels at screening (10 each). The     treatment phase of the study will be a prospective, single-arm, open label protocol. All     patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan     with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.      For analysis of study endpoints, patients in the single intervention arm will be stratified     by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10     pmol/L). The copeptin level used for the two group stratification will be the blinded     copeptin value obtained at baseline from the hospital phase prior to administration of     tolvaptan.   "
148076|NCT01346059|"     Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in     patients after recent antibiotic use. The current standard of care treatment for severe C.     diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is     unsuccessful, it can lead to need for removal of the entire colon or even death. In fact,     mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted     mortality rate is 14% for severe infection. It is believed that the failure of treatment may     stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral     vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin     functions by direct contact with the colon. Therefore, if the vancomycin is instilled     directly into the colon, it can come into contact with and be its intended target. : The     objective of the study is to improve treatment of severe C. diff. colitis . C. diff.     infection is defined as severe if there is evidence of ileus accompanied by any one of the     following: fever greater than 38.30C, , acidemia, serum albumin less than 2.5, or white blood     cell count greater than 14,000.   "
148079|NCT01346020|"     This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using     different approaches and to identify a possible association with disease progression, i.e.     therapy initiation.        1. Samples This monocentric study is carried out using representative bioarchived leukemic          samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived          samples were collected locally at our center during years of diagnostic activity, and          were accurately pathologically, cytogenetically and molecularly characterized.        2. Clinical data The clinical data were retrospectively collected through collaboration          with the referring physicians.        3. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2)          fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the          array data sets, significant results will be validated and in addition, results will be          correlated with clinical data.   "
148080|NCT01346007|"     The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine     safely induces immune responses and immunological memory in children with idiopathic     nephrotic syndrome in remission.   "
148081|NCT01345994|"     This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine     how this central fMRI biomarker is modulated by acupuncture. This study will also investigate     the behavioral consequences of maladaptive cortical plasticity in this disease population.   "
148082|NCT01345981|"     To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg,     and without lidocaine.   "
148083|NCT01345968|"     The primary purpose of this study is to evaluate the safety and efficacy of preoperative     intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement   "
148084|NCT01345942|"     This open label, two period, crossover study will evaluate the safety and the effect of food     on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy     subjects will be randomized to receive a single oral dose of RO5428029 with or without food,     with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after     last dose. Anticipated time on study will be up to 21 days.   "
148085|NCT01345929|"     This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of     CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the     treatment of adults with a cUTI (including pyelonephritis).   "
148086|NCT01345916|"     The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the     corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in     terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.   "
148087|NCT01345903|"     This pilot clinical trial studies robotic-assisted surgery in treating patients with spine     tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may     have fewer side effects and improve recovery   "
148088|NCT01345890|"     The investigators aim is to try to rehabilitate post stroke dysphagia using electrical     stimulation of the mylohyoid muscles.   "
148089|NCT01345877|"     Pain is a complex experience influenced by gender and genetics, and, by psychosocial and     sensory experiences. Pain sensitivity is thus highly variable between individuals.      In the present study we evaluate individuals´ pain perception in response to a number of     different pain stimuli in 100 healthy volunteers (50 females and 50 males).      The data will allow us to assess pain sensitivity, to predict pain responses and to     investigate gender related differences in pain perception.      A second aim is to evaluate the robustness of the different pain-tests since the tests are     repeated with an interval of 2-4 weeks.   "
148090|NCT01345864|"     This study is designed to look at the potential for an investigational drug (PF-04995274,     under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to     reverse changes in memory and learning/problem solving skills caused by co-administration of     a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory     and learning/problem solving skills that are similar to those seen in people with alzheimer's     disease(AD).   "
148091|NCT01345851|"     This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given     together with hypofractionated RT boost and combination chemotherapy in treating patients     with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT     uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays     directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy,     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,     either by killing the cells or by stopping them from dividing. Giving RT together with     combination chemotherapy may kill more tumor cells and allow doctors to save the part of the     body where the cancer started   "
148092|NCT01345838|"     A prospective case-control study of the clinical and radiographic outcome of periacetabular     osteotomy in patients with and without preoperative acetabular labral tears.   "
148093|NCT01345825|"     The purpose and Study hypotheses:      The purpose of the study is to investigate the effect of progressive resistance training in     the early postoperative phase on patients who has had unicompartmental knee replacement. The     hypotheses are that this group compared to a control group will achieve greater muscle     strength and functional ability in terms of gait and working capacity.      Study design:      The subjects will be randomized into two groups; intervention and control. Intervention     group: strength training two times a week supervised by a physiotherapist.      Control group: Training at home, following extradited guidelines.      Endpoint:      Primary endpoint is two months postoperative. The following test will be used: muscle power     test (by a Power Rig), instrumented gait analysis using a combined accelerometer and     gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step     test.      Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.      Sample size:      The power calculation is based on an expected improvement in muscle power by 25%. The risk of     a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that 24     patients are needed in both groups, but 30 patient will be included in both groups to account     for dropouts.      Perspectives:      This study is, to our knowledge, the first study to investigate the effect of strength     training after unicompartmental knee replacement. Moreover it has , to our knowledge not     been. At the moment no guidelines for rehabilitation exist, and research showed that this     group of patients has a decreased function in their daily living compared with the background     population. If, as expected, cases have an overall increased function compared to controls,     this study can provide a basis for future rehabilitation.   "
148094|NCT01345812|"     The primary purpose of the investigation is to identify differences in embryo development     after follicle stimulation with two different gonadotrophins.   "
148095|NCT01345799|"     In Crohn's Disease Patients        -  To evaluate the efficacy of TRK-170        -  To evaluate the PK characteristics of TRK-170        -  To assess the safety of TRK-170   "
148097|NCT01345773|"     Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of     cancer patients. Several guidelines recommendations have been made about the use of     anticoagulation for the prevention and treatment of VTE in Western patients with cancer. In     Western VTE guidelines, all solid cancer patients receiving abdominal major surgery are     strongly recommended to receive pharmacologic prophylactic anticoagulation such as low     molecular weight heparin (LMWH) in the perioperative periods. These guideline recommendations     are based on high incidence of postoperative VTE development in Western cancer patients.     However, there have been many cumulative data about the effect of different ethnicity on the     VTE development and more and more investigators and clinicians admit that Asian ethnicity has     lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply     Western guidelines as it is to the clinical situation of Asian cancer patients.      Although gastric cancer is the common cancer in Asia, there is no prospective data on the     incidence of VTE development during the postoperative period of gastric cancer surgery. In     other words, Asian doctors including Korean clinicians don't know the exact incidence of     surgery-related VTE. From their clinical experiences, most Korean surgeons think that the     incidence of postoperative VTE development is rare. They also have much concern about the     complications such as bleeding that might be caused by routine use of pharmacologic     thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation,     Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW.     Considering these clinical situations in Korea, the uncritical acceptance of Western     guidelines is inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be     answered only from the results of the prospective study on the incidence of postoperative VTE     development after gastric cancer surgery. Moreover, current surgical trend in cancer patients     is minimally invasive approach such as laparoscopic surgery. However, the necessity of     pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not     been evaluated even in Western countries. Western guidelines also cannot exactly answer     whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving     laparoscopic cancer surgery. On above backgrounds, this study was designed.   "
148098|NCT01345760|"     MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length,     capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs     (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of     complementarity. miRNAs have recently been shown to play pivotal roles in diverse     developmental and cellular processes and linked to a variety of skin diseases and cancers. In     the present study, the investigators examines the expression profiles of the microprocessor     complex subunit DGCR8 and the RISC components TARBP1, TARBP2, argonaute-1, argonaute-2 and     PACT in epithelial skin cancer and its premalignant stage.   "
148099|NCT01345747|"     This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV),     end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the     insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective     gynecological laparoscopic surgery.   "
148100|NCT01345734|"     This trial is conducted in Asia. The aim of this trial is to investigate the safety profile     of liraglutide under normal conditions of use.   "
148101|NCT01345721|"     The primary purpose of this study is to evaluate the persistence of bactericidal antibodies     in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study     who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is     measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8     directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the     response one month post an additional dose of Novartis MenACWY will be measured by percentage     of subjects with hSBA titers ≥ 1:8 and GMTs.   "
148102|NCT01345708|"     The aim of this prospective study was to evaluate the activity, safety and the duration of     the response of low dose rituximab associated with standard oral prednisone as first line     therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease,     and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral     prednisone. Further aim was to correlate the clinical response to biological parameters     (cytokine and anti-erythrocyte antibody production in cultures).   "
148103|NCT01345695|"     This study will conduct an evaluation of the World Health Partners (WHP) private provider     project to see if the social franchising and telemedicine project has an impact on health     outcomes in treatment vs. control areas. The evaluation will also estimate specific     parameters of the WHP program that can be used to maximize financial sustainability and     replicability/scalability of the program.   "
148104|NCT01345682|"     This randomised, open-label, phase III study will be performed in patients with R/M head and     neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The     objectives of the trial are to compare the efficacy and safety of afatinib versus     methotrexate   "
148105|NCT01345669|"     This randomised, double-blind phase III trial will be performed in patients with head and     neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy     and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have     received definitive chemo-radiotherapy.   "
148106|NCT01345656|"     A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and     randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally   "
148107|NCT01345643|"     Guidelines for blood transfusion have been issued for years. According to these guidelines,     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the     guidelines, the determination of whether RBCs should be administered when the hemoglobin     level is in the range of 7~10g/dL is based on the judgment from anesthesiologists or     surgeons. Index of transfusion trigger for patients with hemoglobin level between 7/dL and     10g/dL is necessary and important in clinical practice. Based on the aim of blood transfusion     that maintain the balance of oxygen supply and oxygen consumption, the investigators     hypothesize that index of transfusion trigger for patients with hemoglobin level between 7/dL     and 10g/dL could be calculated by their history about heart and blood pressure, and routine     monitoring parameters including pulse oximetry, temperature, and the use of vasoactive     medications. To verify this hypothesis, the investigators present West China Perioperative     Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history     and monitoring parameters, and the investigators design a randomized controlled clinical     trial to test this score.   "
148109|NCT01345617|"     The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat     chloride results that are equivalent to the results from traditional sweat testing. The     secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum     Sweat Test compared to traditional sweat testing.   "
148162|NCT01344928|"     The objectives of this study are to investigate the effects of short-time high-intensity     interval training on tissue glucose and fat metabolism in healthy lean subjects and type 2     diabetic patients using modern and noninvasive imaging methods positron emission tomography     (PET), magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).   "
148110|NCT01345604|"     his study is being done because total knee replacements can leave patients with considerable     pain after surgery. Therefore, many studies have been done to find the best ways to control     knee pain after the surgery. Currently, a popular approach is to use many different     techniques to control the pain. This includes injecting freezing (local anesthetic) into the     spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and     using various kinds of medications (e.g. narcotics and anti-inflammatory medications).     Studies have shown using this a combination of techniques can reduce pain and allow earlier     discharge from the hospital. However, one downside to this approach is it does not usually     control the pain in the back of the knee. One new technique has been used to try and overcome     this. This technique is called a posterior cruciate ligament block or PCL block. It     involves injecting a drug into the back of the knee which will block the nerves in this area.     Sometimes the investigators refer to this as freezing.      The purpose of our study is to determine whether this PCL Block will improve pain after the     total knee replacement surgery. The investigators will also determine whether this technique     will improve movement in the knee and lessen narcotic usage after the surgery.   "
148111|NCT01345591|"     Injuries resulting in facial trauma are common, and can have devastating consequences on your     quality of life. While the facial bones can often be reconstructed, physicians strive to find     better ways to accurately restore injured facial features.      In this clinical trial funded by the Department of Defense, the investigators are evaluating     how effectively fat grafting can restore facial features, and how the filling effect of the     fat graft lasts over time in participants with visible facial injuries. All procedures for     this research study will be performed at the University of Pittsburgh Medical Center.   "
148112|NCT01345578|"     The purpose of this research study is to determine whether partial irradiation of the liver     and liver cell transplantation can provide help for patients with life-threatening     liver-based metabolic diseases who are unlikely to survive without extensive medical therapy     or transplant. The goal of this research study is to determine if liver cell transplants can     be effective as an alternative to organ transplantation. At the present time, liver cell     transplants are experimental and have been done in a limited number of human subjects.   "
148113|NCT01345565|"     The purpose of this research study is to determine whether liver cell transplantation can     provide help for patients with liver failure who are unlikely to survive without some form of     liver support. The goal of this research study is to determine if liver cell transplants can     be effective until a liver transplant is received or until patients recover from their liver     failure.   "
148114|NCT01345552|"     The purpose of this study is to evaluate feasibility of stereotactic body radiation (SRS) in     patients with recurrent oligometastatic disease.   "
148115|NCT01345539|"     The purpose of this study is to evaluate feasibility of radiosurgery for all metastatic sites     for patients presenting with oligometastatic disease.   "
148116|NCT01345526|"     The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to     evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to     doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving     first line cetuximab treatment.   "
148117|NCT01345513|"     This research is being done to find out what types of gene mutations are present in people     with cancer. This study is designed to help researchers and doctors understand more about     cancer. With this information, doctors may have a better idea as to which cancer treatments     are most appropriate for certain patients. The information will also help researchers find     out the how to identify genes in cancers from biopsies and blood samples and how to use this     information to help doctors and patients make treatment decisions.   "
148118|NCT01345500|"     The purpose of the Take Charge Study is to determine among overweight and obese men and women     with type 2 diabetes whether 1) participating in a commercial weight loss program promotes     great weight loss and weight loss maintenance at one year compared to usual care conditions     and 2) whether there is a differential weight loss response to different dietary     macronutrient composition (lower carbohydrate/higher fat diet versus a higher     carbohydrate/lower fat).   "
148119|NCT01345487|"     New Nordic diet guidelines advocate a reduction in consumption of protein from animal sources     such as beef and pork, due to environmental concerns. Instea